US20060200155A1 - Surgical file instrument - Google Patents

Abstract

A reciprocating surgical file system for precisely removing bone and/or other tissue is described. The system allows a user to maneuver the system and navigate into hard-to-access sites under a direct vision mechanism. A transmission mechanism converts rotary motion from a motor into reciprocating motion and provides it to the surgical file for precision removal of bone or other tissue. A pulsatile pump mechanism is operatively coupled with the transmission mechanism and provides irrigating fluid to the surgical site.

Description

RELATED APPLICATIONS
• This application is a continuation-in-part of U.S. application Ser. No. 10/675,068, entitled SHIELDED RECIPROCATING SURGICAL FILE, filed Sep. 29, 2003, which claims the benefit of U.S. Provisional Application No. 60/414,690, filed Sep. 27, 2002, and this application also claims the priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 60/621,843, filed Oct. 25, 2004, U.S. Provisional Application No. 60/621,853, filed Oct. 25, 2004, and U.S. Provisional Application No. 60/701,727, filed Jul. 22, 2005, all of which are hereby incorporated by reference in their entireties.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• The invention relates generally to systems and methods for tissue cutting and removal. More particularly, the invention relates to a reciprocating surgical file system for cutting, removing, grinding, shaping and sculpturing bone and/or tissue material under direct vision.
• 2. Description of the Related Art
• Adjacent spinal vertebrae are spaced by intervertebral discs that are tough and semi-elastic. The discs act as a flexible spacer between the vertebrae that makeup the backbone. Vertebrae are shaped to provide a bony tubular shaped tunnel between upper and lower pairs of vertebrae and this tunnel is made-up in part by the spacing disc. These tubular shaped tunnels are called neuroforamen and serve as a passageway foSSr nerve roots. The size of the neuroforamen tubular shaped tunnels is a close fit for the nerve roots that pass through these tunnels on their way from the spinal cord to the arms, legs and other muscles.
• Each year millions of people encounter neck and back injuries. Many million suffer from truly problematic back pain that either keeps them out of work or debilitates them in some way. Many vertebral and disc injuries result in pain from nerve irritation and compression.
• When an intervertebral disc is damaged, often it is because of a physical overrotation between two vertebrae and normal wear and tear. When a vertebra is overrotated, small facet joints called the zygopophyseal capsules that are located to the left and right sides of the disc are damaged. When the body incurs damage to these small joints, unwanted osteophytes and bony overgrowths frequently occur at the edges of these tiny joints. The unwanted bony overgrowth restricts the neuroforamen and pinches the delicate and sensitive nerve roots.
• Also, with age, for many people, the sensation of thirst is somewhat reduced. As a result, sometimes less water is consumed than needed by the body. The intervertebral discs depend on water as well as other materials to maintain a healthy function. When a disc looses a part of its fluid mass it is the to desiccate. When a disc is desiccated it reduces in height and reduces the space between the two vertebras it is connected to, that is, the neuroforamen becomes constricted and pinches nerve roots.
• Pinched nerves that are constrained in between vertebras can cause neck and back pain. The bony overgrowth and a reduction in the space between vertebras pinch the nerves causing irritation, pain and numbness. The pinching can potentially result in a loss of use of the limbs controlled by the affected nerve.
• Thus, when intervertebral discs are damaged from accident, age and/or general wear and tear the intervertebral nerve roots in the neuroforamen are irritated and pinched and can cause unwanted involuntary muscular contractions. The muscle contractions can come in the form of a continuous low-grade ache or become more severe as a spasm. The muscle contractions can act to further compress the space between the vertebras, which further pinches the nerve. This becomes a severely painful, self-destructive and self-feeding problem.
• One current technology to treat a patient with nerve compression that causes pain and numbness involves the removal of the disc and fusion of the vertebra below with the vertebra above it. Vertebral fusion removes a disc that was flexible and fuses one vertebra together with the adjacent vertebra resulting in a rigid joint between two vertebrae. This causes added strain on the disc above and below the now rigid bone fusion. Sometimes the attempted fusion of one vertebra onto another vertebra is unsuccessful and does not provide the intended fusion.
• Disadvantageously, the intervertebral fusion is an invasive and relatively complicated procedure. In addition, and undesirably, the fusion process can result in a long hospital stay for the patient, a long recuperation and rehabilitation period and high costs for both the patient and care providers.
SUMMARY OF THE INVENTION
• Embodiments of the invention overcome some or all of the above disadvantages by providing systems and methods for tissue cutting and removal including a reciprocating surgical file and a direct vision apparatus. Some embodiments provide surgical instrumentation that allows a surgeon to navigate into small neuroforamina-next to delicate nerves under direct or indirect vision, and locate and remove obstructions of tissue that can cause nerve compression and irritation. Advantageously, this offers many patients a minimally invasive surgical option that can result in shorter hospital stays and lower cost.
• In some embodiments, a surgical instrument comprises a handle assembly and a distal assembly connected to the handle assembly. The distal assembly comprises: a blade having a first width, a lower blade structure having an upper face which has a second width extending between a first lateral side and a second lateral side, the blade being movably mounted to the lower blade structure and slidably coupling with the lower blade structure, wherein the first width is equal to or less than the second width. In some embodiments, the first width is at least about 95% of the second width. In some embodiments, the first width is at least about 80% of the second width. In some embodiments, the blade comprises an exposed cutting surface, the cutting surface configured to perform at least one of grinding, filing, and cutting of tissue. In some embodiments, the blade is axially movable along the lower blade structure. In some embodiments, at least a portion of the lower blade structure is tapered in the distal direction. In some embodiments, the distal assembly forms an minimally traumatic tip that is dimensioned so as to fit into a neuroforamen without appreciable trauma to a nerve extending through the neuroforamen. In some embodiments, the lower blade structure defines a shield on one side of the distal assembly, and the blade is disposed on another side of the distal assembly. In some embodiments, the blade and the upper face are curved about a long axis of the lower blade structure. In some embodiments, the lower blade structure defines a fluid delivery channel, the blade is axially moveable between a proximal position and a distal position. A window for expelling fluid is at a distal end of the fluid delivery channel which is defined between the blade and the lower blade structure when the occupies a proximal position.
• In some embodiments, the blade has a cutting zone comprising a cutting surface. The cutting surface can be convex. In some embodiments, the cutting zone comprises cutting elements configured to remove tissue. In some variations, the cutting elements are self-sharpening. The cutting elements can be spaced evenly or unevenly along the cutting zone.
• In some embodiments, a surgical instrument has a distal assembly comprising a blade and a lower blade structure. The blade can have a first blade edge and a second blade edge. The lower blade structure comprises an upper face between a first structure edge and a second structure edge. The blade is positioned upon the upper face and is movable relative to a lower blade structure. The first blade edge is proximate to the first structure edge and the second blade edge is proximate to the second structure edge. In some embodiments, the first blade edge and the second blade edge are opposing, longitudinally extending lateral edges of the blade. The first and second blade edges define a blade width. The first structure edge and the second structure edge are opposing, longitudinally extending lateral edges of the lower blade structure. The first and second structure edges define a lower blade structure width. The blade width is equal to or greater than the lower blade width. A blade width is defined between the first blade edge and the second blade edge, a lower blade structure width is defined between the first structure edge and the second structure edge. The blade width is substantially similar to the lower blade structure width. The periphery of at least a portion of the blade has a similar shape to a periphery of at least a portion of the lower blade structure. In some embodiments, at least a portion of a surface of the blade conforms to a periphery of at least a portion of the lower blade structure. In some embodiments, the lower blade structure has a shield surface opposing the upper face, and the shield surface forms a tip that curves towards the blade. The lower blade structure has a shield surface opposing the upper face, and at least a portion of the shield surface is convex towards the blade. In some embodiments, the lower blade structure has a shield surface opposing the upper face, and at least a portion of the shield surface is concave towards a nerve extending through a neuroforamen, when the lower blade structure is positioned at least partially in the neuroforamen. In some embodiments, the lower blade structure has a shield surface opposing the upper face, and at least a portion of the shield surface is concave about a longitudinal axis of the lower blade structure. In some embodiments, the lower blade structure has a longitudinally extending fluid delivery channel disposed along the lower blade structure and a plurality of channels in communication with the delivery channel. In some embodiments, the blade further comprises a plurality of throughholes, the blade is movable between a proximal position and a distal position, at least one throughhole is positioned near the first structure edge and at least one throughhole is positioned near the second structure edge. In some embodiments, the lower blade structure further comprises an elongate delivery channel and a plurality of channels. The elongate delivery channel extends along the lower blade structure. The plurality of channels are in communication with the delivery channel. At least one of the delivery channels is aligned with at least one of the throughhole blade. In some embodiments, the distal assembly forms a tip that is dimensioned so as to fit into a neuroforamen without producing appreciable trauma to a nerve extending through the neuroforamen.
• In some embodiments, an instrument comprises a blade and a lower blade structure. The blade has an upper filing surface. The blade is slidably coupled with the lower blade structure. The blade and the lower blade structure are each convexed away from the upper filing surface. In some embodiments, the distal assembly further comprises a tip. The tip is dimensioned so as to fit into a neuroforamen without producing appreciable trauma to a nerve extending through the neuroforamen. In some embodiments, the blade has a first transverse width and the lower blade structure has a second transverse width. The first transverse width is about the same as the second transverse width. In some embodiments, the blade has a first transverse width and the lower blade structure has a second transverse width. The first transverse width is less than the second transverse width. In some embodiments, the blade has a first transverse width and the lower blade structure has a second transverse width. The first transverse width is greater than the second transverse width. In some embodiments, the blade has a first transverse width and the lower blade structure has a second transverse width. The first transverse width is less than about 95% of the second transverse width.
• In some embodiments, the blade has a cutting zone having a transverse width that is generally similar to a transverse width of the blade. In some embodiments, the cutting zone has a transverse width that is generally similar to a transverse width of a lower blade structure. In some embodiments, the cutting zone comprises one or more of the following: cutting teeth, filing elements, sharpened edges, and the like. In some embodiments, the cutting zone has a generally rectangular shape. In some embodiments, the cutting zone is an array of cutting elements positioned evenly or unevenly through the cutting zone. In some embodiments, the cutting zone is an array of cutting elements forming throughholes. The cutting elements can be positioned evenly or unevenly through the cutting zone.
• In some embodiments, an instrument has a distal assembly for removing tissue. The distal assembly forms an atraumatic tip that is dimensioned so as to fit into a neuroforamen without appreciable trauma to the nerve extending through the neuroforamen. In some variations, the distal assembly has a movable blade configured to remove tissue.
• In some embodiments, a surgical instrument comprises a filing surface configured to cut, grind, and/or file tissue. A shield surface is coupled to the filing surface. The instrument is configured to be positioned at least partially in a neuroforamen having a nerve extending therethrough. At least a portion of the shield surface is concave towards the nerve when the instrument is positioned at least partially in the neuroforamen. In some variations, the neuroforamen is a vertebral foramen.
• In some embodiments, a surgical instrument comprises a filing surface configured to cut, grind, and/or file tissue. A shield surface is coupled to the filing surface. At least a portion of the shield surface is convex towards the filing surface. In some variations, the instrument is configured to be positioned at least partially in a mammalian neuroforamen having a nerve extending therethrough.
• In some embodiments, a surgical instrument comprises means for grinding a first tissue, means for shielding a second tissue from the means for grinding when the second tissue is in proximity to the first tissue, and at least part of the means for shielding is convex towards the means for grinding.
• In some embodiments, an instrument has a distal assembly that forms an atraumatic tip. The atraumatic tip is dimensioned so as to fit into a vertebral foramen, having nerve extending through the vertebral foremen, without appreciable trauma to the nerve. The distal tip can have an actuatable member for cutting, filing, and/or grinding tissue. The tissue can be bone tissue.
• In some embodiments, a method of treating a patient is provided. The method comprises placing a distal assembly of an instrument at least partially in a neuroforamen having a nerve extending therethrough. At least a portion of the distal assembly is concave towards the nerve. Tissue is removed from the patient by operating the distal assembly. In some variations, the removing of tissue comprises at least one of cutting, filing, and grinding. In some embodiments, the removing of tissue comprises at least one of cutting, filing, and grinding. In some embodiments, the method further comprises oscillating a blade of the distal assembly to remove the tissue. In some embodiments, the method further comprises coupling a powered handpiece to the distal assembly of the instrument, and the powered handpiece has a drive system for driving a movable blade of the distal assembly. In some embodiments, the powered handpiece is a rotary handpiece and the instrument further comprises a mechanical transmission that converts rotary motion of the powered handpiece to reciprocating, linear motion. In some embodiments, the method further comprises positioning an access device in a patient's body, and advancing the distal assembly through the access device until the distal assembly reaches a target location for tissue removal. In some embodiments, the tissue is removed by reciprocating a blade while at least a portion of the distal assembly remains in the neuroforamen.
• In some embodiments, method of treating a patient comprises: placing a distal assembly of an instrument at least partially into a neuroforamen between target tissue and a nerve; removing the target tissue from surrounding tissue with the distal assembly; after removing the target tissue, drawing the target tissue into the distal assembly; and moving the target tissue through the distal assembly. In some embodiments, the drawing the target tissue into the distal assembly comprises drawing the target tissue through an inlet port of the distal assembly and through a lumen extending from the inlet port through the distal assembly. In some embodiments, the method further comprises: delivering irrigation fluid out of the distal assembly as the distal assembly removes the target tissue such that the irrigation fluid is mixed with the target tissue; and drawing the mixture of target tissue and irrigation fluid into and through the distal assembly. In some embodiments, the distal assembly is substantially L-shaped and has a cutting blade for removing tissue.
• In some embodiments, a surgical instrument comprises a housing that contains a drive system. A distal assembly has a distal tip configured to perform at least one of grinding tissue, filing tissue, and cutting tissue. The distal assembly extends from the housing and engages the drive system of the housing. A lumen extends through the housing and the distal assembly. The lumen is configured to receive at least a portion of an endoscope such that an optical element of the endoscope is positioned to provide endoscopic viewing of the distal tip. In some embodiments, the instrument is further configured to permit releasable engagement of the endoscope to the housing. In some embodiments, the distal tip is curved and comprises a blade and a lower blade structure. The blade is slidably disposed on the lower blade structure. In some embodiments, the distal assembly has a longitudinal axis, wherein the endoscope provides viewing of the distal tip when the distal tip is offset from the longitudinal axis.
• In some embodiments, a surgical instrument comprises a body assembly that has a distal tip configured to remove bone from a mammal. The body assembly is configured to hold releasably an endoscope such that the endoscope is positioned to provide viewing of the distal tip when the distal tip removes bone. In some embodiments, the surgical instrument further comprises a passageway extending through the body assembly, wherein the passageway is sized to receive the endoscope. In some embodiments, the distal assembly has a curved distal tip that comprises a movable blade coupled to a lower blade structure. In some embodiments, the body assembly has a longitudinal axis, wherein the endoscope provides viewing of the distal tip when the distal tip is offset from the longitudinal axis. In some embodiments, the surgical instrument further comprises the endoscope.
• In some embodiments, a method of assembling an instrument is provided. The method comprises placing a distal end of a visualization instrument into a body assembly. The body assembly has an outwardly extending distal assembly which is configured to remove bone from a mammal. The distal end of the visualization instrument is advanced through a lumen extending through the distal assembly. The distal end of the visualization instrument is positioned so that the visualization instrument is capable of providing viewing of at least a portion of the distal assembly. In some embodiments, the method further comprises locking the visualization instrument to the body assembly. In some embodiments, the body assembly has a longitudinal axis. The visualization instrument is configured to provide viewing of a distal tip of the distal assembly when the distal tip is offset from the longitudinal axis. In some embodiments, the distal assembly is configured to perform at least one of grinding tissue, filing tissue, cutting tissue, when driven by a drive system of the housing. In some embodiments, the method further comprising removing the visualization instrument out of the lumen after performing a surgical procedure. In some embodiments, the visualization instrument is an endoscope.
• In some embodiments, a surgical distal module comprises a distal body configured to attach to a handle assembly. The surgical distal module further comprises a blade coupled to the distal body. The blade is configured to be slidably moved in a reciprocating linear way by rotary motion emanating from the handle assembly. The module is further configured to remove bone from a mammal. In some variations, the module further comprises a protrusion extending from the distal body. The protrusion is configured to be gripped by a clinician while the blade removes the bone. The protrusion can be dimensioned so as to be gripped between a thumb and a finger of a user. In some embodiments, the module further comprising a protrusion extending from the distal body, wherein the protrusion is configured to be gripped by a clinician while the blade removes the bone. In some embodiments, the protrusion is dimensioned so as to be gripped between a thumb and a finger of a user. In some embodiments, further comprising a transmission that converts the rotary motion to linear reciprocating motion. The transmission can be a toroidal drive system. In some embodiments, the blade and the protrusion are on substantially opposite sides of the distal tip body. In some embodiments, the module comprises a coupling assembly at a proximal end of the distal body. The coupling assembly is configured to releasably couple to the handle assembly. In some embodiments, the blade has a convex surface. In some embodiments, the convex surface is configured to perform at least one of grinding, cutting, or filing the bone. In some embodiments, the blade has a concave surface configured to perform at least one of grinding, filing, and cutting the bone.
• In some embodiments, a blade for removing tissue comprises an elongated blade body having an upper surface and an opposing lower surface. A plurality of raised cutting elements extends from the upper surface, each of the cutting elements defining a cutting edge for removing tissue. The cutting edge is substantially parallel to at least one of the upper surface and lower surface. In some embodiments, the cutting elements are adapted to remove bone by at least one of grinding, cutting, and filing. In some embodiments, the raised cutting elements each have a throughhole extending through the elongated blade body. In some embodiments, the elongated blade body has an arcuate transverse axis. In some embodiments, the cutting edge is substantially flat. In some embodiments, the cutting edge is substantially parallel to the transverse axis. In some embodiments, the cutting edge is arcuate. In some embodiments, the raised cutting elements each have a substantially frusto-conical shape. In some embodiments, the raised cutting elements are substantially self-sharpening. In some embodiments, the blade is movably coupled to a lower blade structure of a surgical instrument. In some embodiments, the blade is dimensioned so as to fit at least partially within a neuroforamen.
• In some embodiments, a blade for removing tissue comprises a blade body having an upper face and a lower face. The upper face and the lower face extend between a first edge and a second edge. A plurality of raised elements for removing tissue is provided. The raised elements extend from the upper face. Each of the raised elements has a cutting edge that is substantially concentric to an arcuate transverse axis of the blade body. In some embodiments, the blade body is dimensioned so as to fit at least partially within a neuroforamen. In some embodiments, the raised elements form an array of cutting elements that effectively remove tissue when the blade is actuated. In some embodiments, the raised elements each have a throughhole extending through the blade body. In some embodiments, the cutting edge is substantially flat. In some embodiments, the raised elements are substantially frusto-conical in shape. In some embodiments, the cutting edge is defined at a junction of an outer surface and an inner surface of the cutting element. In some embodiments, the raised elements are substantially self-sharpening.
• In some embodiments, a blade for removing tissue comprises a blade body that has an upper face and a lower face. The upper face and the lower face extend between a first edge and a second edge. A plurality of cutting elements for removing tissue extend from the upper face. Each of the raised elements has a cutting edge that is substantially concentric to an curved transverse axis of the blade body.
• In some embodiments, a surgical instrument comprises a blade for removing tissue. The blade has a plurality of throughholes. A lower blade structure couples to the blade. The lower blade structure comprises a fluid delivery channel that extends substantially along a long axis of the lower blade structure. At least a portion of the fluid delivery channel is aligned with at least one of the throughholes in the blade so as to permit flow through the at least one of the throughholes. The blade is configured to move along the long axis with respect to the lower blade structure. In some embodiments, the instrument is configured to produce pulsatile flow of fluid when the blade is moved reciprocally along the long axis. In some embodiments, the instrument is configured to produce a substantially pulsatile flow of fluid when the blade is moved reciprocally along the long axis, and while the fluid is supplied to the fluid delivery channel at a substantially constant pressure. In some embodiments, at least one of the throughholes is adjacent to the fluid delivery channel such that fluid can flow substantially continuously through the at least one of the throughholes. In some embodiments, at least one of the throughholes is aligned with the fluid delivery channel to permit fluid through the at least one of the throughholes when the blade is in a first position with respect to the lower blade structure, and wherein the at least one of the throughholes is not aligned with the fluid delivery channel when the blade is in a second position with respect to the lower blade structure. In some embodiments, the fluid delivery channel comprises a elongate portion extending along the long axis and a plurality of side channels extending from the elongate portion. In some embodiments, the instrument is configured to permit fluid flow from at least one side channel through at least one of the throughholes when the at least one throughhole is aligned with the at least one side channel. In some embodiments, the instrument is configured to substantially obstruct fluid flow from the at least one side channel through the at least one of the throughholes when the at least of the one throughholes is not aligned with the at least one side channel. In some embodiments, the blade is configured to move reciprocally such that the at least one of the throughholes and at least one of the side channels are alternatingly aligned and not aligned.
• In some embodiments, a surgical instrument comprises means for removing tissue from a mammal and means for delivering fluid through the means of removing tissue. Movement of the means for removing tissue produces substantially pulsatile flow.
• In some embodiments, a surgical instrument comprises a blade configured to remove tissue from a patient. A lower blade structure couples with the blade. Reciprocating motion of the blade with respect to the lower blade structure generates substantially pulsatile flow of fluid through the blade when the fluid is supplied to the lower blade structure at a substantially constant pressure.
• In some embodiments, the tissue is bone. In some embodiments, the lower blade structure comprises a fluid delivery channel configured to permit fluid flow therethrough. In some embodiments, the blade comprises at least one throughhole that is adjacent to the fluid delivery channel such that fluid can flow substantially continuously through the at least one throughhole. In some embodiments, the blade comprises at least one throughhole that is aligned with the fluid delivery channel to permit fluid through the at least one throughhole when the blade is in a first position with respect to the lower blade structure, and wherein the at least one throughhole is not aligned with the fluid delivery channel when the blade is in a second position with respect to the lower blade structure. In some embodiments, the fluid delivery channel comprises an elongate portion extending along a long axis of the lower blade structure and a plurality of side channels extending from the elongate portion. In some embodiments, the blade comprises at least one throughhole, wherein the instrument is configured to obstruct substantially fluid flow from the at least one of the plurality of side channels through the at least one throughhole when the at least one throughhole is not aligned with the at least one of the plurality of side channels. In some embodiments, the blade is configured to move reciprocally such that the at least one throughhole and at least one of the plurality of side channels are alternatingly aligned and not aligned.
• Kits can be provided that include at least one of the components, devices, or assemblies disclosed herein. The kits can include instructions for using the components, devices, or assemblies in a procedure. The instructions can be recorded on a suitable recording medium. For example, the instructions may be printed on a substrate, such as paper, plastic, packaging, etc. As such, the instructions may be present in the kits as a package insert, in the labeling of the container of the kit or components thereof (e.g., packaging, sub-packaging, etc.). In other embodiments, the instructions are present as an electronic storage data file present on a suitable computer readable storage medium. The instructions may take any form, including complete instructions for how to use, assemble, or perform other methods described herein.
• Embodiments of the invention can desirably be adapted and tailored to serve at least three surgical fields. These include, but are not limited to, neurosurgery, orthopaedic surgery and plastic surgery. The neurosurgical embodiments enable surgeons to safely enlarge the constricted neuroforamen and provide more space for the nerve roots to pass through the rigid bony vertebral structure, thereby relieving the nerve pinching and compression.
• The orthopaedic embodiments provide improved bone and/or tissue removal instrumentation and methodology, for example, for orthopaedic surgical procedures such as knee surgery. The plastic surgery embodiments provide improved bone and/or tissue sculpturing instrumentation and methodology, for example, for cosmetic surgical procedures such as nose reshaping or rhinoplasty.
• Some embodiments include a surgical instrument comprising a blade; a housing in which the blade moves, the housing having a long axis; a transmission that converts rotary motion to reciprocating, linear motion, wherein the transmission is coupled to the blade such that the blade moves reciprocally in the housing; a first opening in the housing through which a portion of the blade is exposed; and a cutting surface on the exposed portion of the blade, the surface configured to perform at least one of grinding, filing, and cutting of tissue.
• In some embodiments the housing is concave about at least a portion of its long axis, such as at least a distal portion of its long axis. In some embodiments, the housing is convex about at least a portion of its long axis, such as at least a distal portion of its long axis. In some embodiments, the first opening is in an opening surface on the housing. In some embodiments, the housing is curved along its long axis, to assist in placing the surgical instrument in the body of a patient. In some embodiments the blade is substantially flat.
• In some embodiments, the housing is curved along its long axis in a direction toward the opening surface. Some embodiments further comprise at least one bearing retainer for reducing friction. In some embodiments the at least one bearing retainer has at least one slot configured to transmit fluid toward a distal end of the instrument. Some embodiments further comprise at least one fiberoptic in or on the housing, for transmission of at least one of a video signal and illumination light. In some embodiments the housing has at least a second opening at a distal end of the housing.
• Some embodiments further comprise at least two lenses coupled to the at least one fiberoptic. In some embodiments, at least one of the at least two lenses is disposed at a distal end of the housing, and another of the at least two lenses is disposed in proximity to the first opening in the housing. Some embodiments further comprise a pump for pumping fluid through the surgical instrument. In some embodiments the pump is mechanically coupled to the transmission. In some embodiments, the transmission comprises: two surfaces that are a substantially fixed distance apart; a cam that rotates about a central axis, the central axis being at an angle to a plane extending between the two surfaces; and the cam having a curvilinear body, the body having a nonuniform thickness, wherein the body continuously contacts the two surfaces as the cam rotates about the central axis, such that the two surfaces remain at the substantially fixed distance apart as they move linearly in response to the cam's rotation about the central axis.
• In some embodiments, the cam's central axis is substantially parallel to a direction of the linear motion of the two surfaces. In some embodiments, the central axis is substantially perpendicular to the plane extending between the two surfaces. In some embodiments the two surfaces move linearly back and forth in reciprocating motion in response to the cam's rotation about the central axis. In some embodiments the curvilinear body has a shape comprising at least two toruses, the at least two toruses being partially superimposed, and each of the at least two toruses has a central axis, wherein the central axes of the at least two toruses are at an angle to each other. In some embodiments at least one bearing comprises the two surfaces. In some embodiments two bearings respectively comprise the two surfaces.
• In some embodiments the curvilinear body is disposed at an angle to the central axis of the cam. Some embodiments include an apparatus for translating a rotary motion to a linear motion, the apparatus comprising: two surfaces that are a substantially fixed distance apart; and a cam that rotates about a central axis, the central axis being at an angle to a plane extending between the two surfaces; the cam having a curvilinear body, the body having a nonuniform thickness, wherein the body continuously contacts the two surfaces as the cam rotates about the central axis, such that the two surfaces remain at the substantially fixed distance apart as they move linearly in response to the cam's rotation about the central axis.
• In some embodiments, the cam's central axis is substantially parallel to a direction of the linear motion of the two surfaces. In some embodiments the central axis is substantially perpendicular to the plane extending between the two surfaces. In some embodiments the two surfaces move linearly back and forth in reciprocating motion in response to the cam's rotation about the central axis. In some embodiments the curvilinear body has a shape comprising at least two toruses, the at least two toruses being partially superimposed, and each of the at least two toruses has a central axis, wherein the central axes of the at least two toruses are at an angle to each other.
• In some embodiments at least one bearing comprises the two surfaces. In some embodiments two bearings respectively comprise the two surfaces. In some embodiments the curvilinear body is disposed at an angle to the central axis of the cam. In some embodiments a pump comprises: a fluid path; two plungers configured to at least partially occlude the fluid path; a cam configured to cause the two plungers to at least partially occlude the fluid path alternatingly; and at least one check valve along the fluid path for reducing backflow of fluid within the fluid path.
• In some embodiments the cam translates in a direction that is substantially perpendicular to a long axis of at least one of the two plungers. In some embodiments the cam translates in a direction that is substantially perpendicular to a long axis of each of the two plungers. In some embodiments, the pump comprises: a fluid path; two plungers configured to at least partially occlude the fluid path; a cam configured to cause the two plungers to at least partially occlude the fluid path alternatingly; and at least one check valve along the fluid path for reducing backflow of fluid within the fluid path.
• In some embodiments the cam translates in a direction that is substantially perpendicular to a long axis of at least one of the two plungers. In some embodiments the cam translates in a direction that is substantially perpendicular to a long axis of each of the two plungers. Some embodiments of the instrument further comprise at least one opening in the exposed portion of the blade, for transmitting fluid. In some embodiments the cutting surface comprises an abrasive material. In some embodiments the cutting surfaces comprises diamond. In some embodiments the blade comprises stainless steel.
• In some embodiments, a blade may have one or more throughholes. As used herein, the term “throughholes” has a broad meaning that includes, but is not limited to, any channel or passageway that permits fluid flow from one side of structure to another.
• Some embodiments further comprise a handpiece coupled to the housing. Some embodiments further comprise a video camera. In some embodiments the camera is configured to couple with a fiberoptic that extends to a distal end of the housing. In some embodiments a video camera is located in the handpiece. Some embodiments further comprise a watertight seal in the handpiece. In some embodiments the handpiece is configured to contain the video camera in a chamber such that the watertight seal reduces or prevents ingress of at least one of water and bacteria from outside the handpiece into the chamber containing the video camera in the handpiece.
• Some embodiments further comprise a motor in the handpiece, the motor configured to power the rotary motion. In some embodiments the motor comprises a gas turbine. Some embodiments further comprise a cord configured to couple to a proximal end of the surgical instrument, the cord comprising at least one of a fiberoptic, an electrical line, an irrigation channel, a suction line, and a gas tube for powering a gas turbine motor in the surgical instrument.
• For purposes of summarizing the invention, certain aspects, advantages and novel features of the invention have been described herein above. Of course, it is to be understood that not necessarily all such advantages may be achieved in accordance with any particular embodiment of the invention. Thus, the invention may be embodied or carried out in a manner that achieves or optimizes one advantage or group of advantages as taught or suggested herein without necessarily achieving other advantages as may be taught or suggested herein.
• All of these embodiments are intended to be within the scope of the invention herein disclosed. These and other embodiments of the invention will become readily apparent to those skilled in the art from the following detailed description of the preferred embodiments having reference to the attached figures, the invention not being limited to any particular preferred embodiment(s) disclosed.
BRIEF DESCRIPTION OF THE DRAWINGS
• Having thus summarized the general nature of the invention and some of its features and advantages, certain preferred embodiments and modifications thereof will become apparent to those skilled in the art from the detailed description herein having reference to the figures that follow, of which:
• FIG. 1 is a schematic view of a surgical file system illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 2 is a perspective view of the surgical file system ofFIG. 1.
• FIG. 3 is a perspective view of a surgical file device with a curved distal tip configuration illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 4 is a perspective view of a surgical file device with a straight distal tip configuration illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 5 is a side view of a surgical file device illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 6 is a partially exploded view of the surgical file device ofFIG. 5.
• FIG. 7 is a perspective view of the surgical file device ofFIG. 5 with the distal cover removed illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 8 is a perspective view of a distal tip assembly of the surgical file device ofFIG. 5.
• FIG. 9 is a simplified exploded perspective view of the distal tip assembly ofFIG. 8 illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 10 is a sectional view along line10-10 ofFIG. 5 illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 11 is a sectional view along line11-11 ofFIG. 5 illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 12 is a simplified perspective view of a surgical cutting blade illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 13 is a simplified schematic cross-section view of a convex surgical file cutting surface illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 14 is a schematic cross-section view of a concave surgical file cutting surface illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 15 is a schematic side view sectional view of surgical file distal tip with a top cutting surface illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 16 is a schematic side sectional view of a surgical file distal tip with a top cutting surface illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 17 is a perspective view of a surgical file cutting surface with abrasives illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 18 is a perspective view of a surgical file cutting surface with irrigation fluid openings illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 19 is a schematic view of a surgical file cutting blade with irrigation fluid flow therethrough illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 20 is a cross-section view of a surgical file distal cutting tip with irrigation fluid passageways illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 21 is a side sectional view of a surgical file distal cutting tip with a linear reciprocation stroke illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 22 is a side sectional view of a surgical file distal cutting tip with fiber optic probes illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 23 is a sectional view along line23-23 ofFIG. 22 illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 24 is a simplified side sectional view of a surgical file distal cutting tip with an illumination and vision system illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 25 is a schematic view of an arrangement of lenses of a surgical file illumination and vision system illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 26 is a schematic view of display images provided by a surgical file illumination and vision system illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 27 is a simplified perspective view of a dual torus and drive shaft illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 28 is a simplified side view of the dual torus and drive shaft ofFIG. 27.
• FIG. 29 is a simplified schematic view of a dual torus partial superposition illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 30 is a schematic graphical representation of variation in outer rim thickness of a dual torus or toroid illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 31A is a sectional view along line31-31 ofFIG. 28 illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 31B is a sectional view along line31-31 ofFIG. 28 illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 31C is a sectional view along line31-31 ofFIG. 28 illustrating features and advantages in accordance with yet another embodiment of the invention.
• FIG. 32 is a perspective view of a distal cutting blade and a reciprocating slide plate that connects to the blade illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 33 is a schematic side view of a distal cutting blade connected to a slide blade illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 34 is a schematic view of toroid drive and associated bearings illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 35 is a schematic view of toroid drive and associated bearings illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 36 is a perspective view of a surgical file transmission system in a test set-up illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 37 is a side cross-sectional view of a surgical file pulsatile pump system illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 38 is a side cross-sectional view of a surgical file pulsatile pump system illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 39 is an exploded perspective view of a surgical file powered handpiece illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 40A is a sectional view along line40-40 ofFIG. 39 illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 40B is a sectional view along line40-40 ofFIG. 39 illustrating features and advantages in accordance with another embodiment of the invention.
• FIG. 40C is a sectional view along line40-40 ofFIG. 39 illustrating features and advantages in accordance with yet another embodiment of the invention.
• FIG. 41 is a schematic view of a bone and/or tissue removal procedure illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 42 is a simplified perspective view of a bone and/or tissue removal procedure on a plastic anatomical model of the human spine illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 43 simplified side view of an orthopaedic surgical file instrument illustrating features and advantages in accordance with an embodiment of the invention.
• FIG. 44 is a simplified front view of a distal cutting assembly of the surgical file instrument ofFIG. 43.
• FIG. 45 is a simplified bottom view of the distal cutting assembly ofFIG. 44.
• FIG. 46 is a perspective view of a surgical instrument in accordance with another embodiment.
• FIG. 47 is an exploded view of the surgical instrument ofFIG. 46.
• FIG. 48 is a perspective view of the surgical instrument ofFIG. 46 being assembled.
• FIG. 49 is a partial cross-sectional view of the surgical instrument ofFIG. 46. A portion of the surgical instrument is positioned through an access device.
• FIG. 50 is a cross-sectional side view of a body assembly of the surgical instrument ofFIG. 49.
• FIG. 50A is an enlarged cross-sectional side view of the surgical instrument ofFIG. 49 taken along50A-50A.
• FIG. 51 is a cross-sectional side view of a distal end of the surgical instrument ofFIG. 49 performing a procedure.
• FIG. 52 is a perspective view of the distal end of the surgical instrument ofFIG. 51.
• FIG. 53 is a longitudinal cross-sectional view of the distal end of the surgical instrument ofFIG. 51.
• FIG. 54 is a simplified side view of a bone and/or tissue removal procedure on a human spine.
• FIG. 55 is a side view of a bone and/or tissue removal procedure on a human spine in accordance with another embodiment.
• FIG. 56 is a partial cross-sectional view of a surgical instrument having a drive system in accordance with another embodiment.
• FIG. 57 is a front view of a slide plate connector of a drive member of the drive system ofFIG. 56.
• FIG. 58 is a side view of the slide plate connector ofFIG. 57.
• FIG. 59 is a front view of a slide plate of the drive system ofFIG. 56.
• FIG. 60 is a perspective view of a surgical instrument in accordance with another embodiment. The surgical instrument has a removable distal tip assembly attached to a handle assembly.
• FIG. 61A is a cross-sectional view of a distal tip assembly that is attached to a handle assembly.
• FIG. 61B is a cross-sectional view of the distal tip assembly ofFIG. 61A having a blade assembly removed.
• FIG. 62 is a cross-sectional view of a distal tip assembly in accordance with another embodiment.
• FIG. 63 is a perspective cross-sectional view of the distal tip assembly ofFIG. 62.
• FIG. 63A is a perspective cross-sectional view of the distal tip assembly ofFIG. 62 outputting a fluid.
• FIG. 64 is another perspective cross-sectional view of the distal tip assembly ofFIG. 62.
• FIG. 65 is a perspective view of a distal tip assembly in accordance with another embodiment.
• FIG. 66 is another perspective view of the distal tip assembly ofFIG. 65.
• FIG. 67 is a side view of the distal tip assembly ofFIG. 65.
• FIG. 68 is a perspective view of a distal tip assembly in accordance with another embodiment.
• FIG. 69 is a perspective view of a surgical instrument in accordance with another embodiment.
• FIG. 70 is an elevation view of the surgical instrument ofFIG. 69.
• FIG. 71 is an enlarged top view of the surgical instrument ofFIG. 70 taken along71-71.
• FIG. 72A is a cross-sectional view of the surgical instrument ofFIG. 71 taken along theline72A-72A.
• FIG. 72B is a cross-sectional view of the surgical instrument ofFIG. 71 taken along theline72B-72B.
• FIG. 73 is a perspective view of the surgical instrument ofFIG. 69. A blade of the instrument has been removed.
• FIG. 74 is a perspective view of a distal end of the surgical instrument ofFIG. 73.
• FIG. 75 is a perspective view of a blade assembly of the surgical instrument ofFIG. 69.
• FIG. 76 is a longitudinal cross-sectional view of the blade assembly ofFIG. 75.
• FIG. 77 is a longitudinal cross-sectional view of the distal end of the surgical instrument ofFIG. 69.
• FIG. 78 is a perspective view of the distal end of the surgical instrument ofFIG. 69 having a blade in a distal position.
• FIG. 79 is a perspective view of the distal end of the surgical instrument ofFIG. 69 having the blade in a proximal position.
• FIG. 80 is a perspective view of internal components of the surgical instrument ofFIG. 69.
• FIG. 81 is a longitudinal cross-sectional view of a portion of the surgical instrument ofFIG. 69.
• FIG. 82 is a longitudinal cross-sectional view of a portion of the surgical instrument ofFIG. 69, wherein components have been removed.
• FIG. 83 is a longitudinal cross-sectional view of a portion of the surgical instrument ofFIG. 69 delivering out a fluid.
• FIG. 84 is another perspective view of the surgical instrument ofFIG. 69.
• FIG. 85 is perspective view of a power device attached to the surgical instrument ofFIG. 84.
• FIG. 86 is a perspective view of the assembled instrument ofFIG. 85 held in a clinician's hand.
• FIG. 87 is a perspective view of a blade for a surgical instrument.
• FIG. 88 is a cross-sectional view of the blade ofFIG. 87 taken along the line88-88.
• FIG. 89 is a cross-sectional view of a distal tip assembly of a surgical file instrument, the distal tip assembly is positioned between vertebral bone and a nerve.
• FIG. 90 is a perspective view of another embodiment of a surgical instrument.
• FIG. 91 is a perspective view of a distal tip of the surgical instrument ofFIG. 90 taken along91-91.
• FIG. 92 is a side elevational view of the surgical instrument of FIG..90.
• FIG. 93 is an enlarged side view of a distal tip of the surgical instrument ofFIG. 92 taken along93-93.
• FIG. 94 is a longitudinal cross-sectional view of the distal tip of the surgical instrument ofFIG. 90.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The preferred embodiments of the invention described herein relate generally to systems and methods for tissue cutting and removal and, in particular, to a reciprocating surgical file system for cutting, removing, shaping and sculpturing bone and/or tissue material under direct vision.
• While the description sets forth various embodiment specific details, it will be appreciated that the description is illustrative only and should not be construed in any way as limiting the invention. Furthermore, various applications of the invention, and modifications thereto, which may occur to those who are skilled in the art, are also encompassed by the general concepts described herein.
• FIGS. 1 and 2 show asurgical file system10 generally comprising a motorized reciprocating surgical file instrument, apparatus, assembly ordevice12 and a mobileportable control system14 connected via a flexibleumbilical cable16. Thesurgical file device12 generally comprises adistal tip assembly18 and apowered handpiece20. Reciprocating as used herein generally includes back and forth motion and to and from motion.
• Thesystem14 generally comprises a mobile portable stand, cabinet ortrolley22 that supports a controller or control unit orbox24 and acomputer system26. In on embodiment, thesystem14 has a footprint of about 0.2 m²(2 square feet (ft²)) and a height of about 1.8 m (6 feet (ft)). In modified embodiments, other suitable dimensions may be efficaciously used, as needed or desired. Thesystem14 may also utilize wireless communication.
• Thecabinet22 has a plurality of drawers orcompartments28 to store system parts, including spare parts, such as cables, connection lines,powered hand piece20 and an array of various disposable distal cutting tip assemblies, for example, for neurosurgery, orthopaedic surgery and plastic surgery. Thestorage drawers28 also serve to store instructions.
• Thecabinet22 has a plurality ofwheels30 such as caster wheels to enable movement of thesystem14. In the illustrated embodiment, thecabinet22 has fourwheels30. Thecaster wheels30 have wheel locks or other suitable fastening mechanisms to enable stationarily locking the unit at the desired position in the operating room or other area.
• Thecomputer system26 comprises a central processing unit (CPU)32, amonitor34, akeyboard36 including a mouse and a color printer to produce color pictures. TheCPU32 may be supported on (see, for example,FIG. 1) or within (see, for example,FIG. 2) themovable cabinet22. TheCPU32 includes a video processing system, such as but not limited to a data acquisition board and the like, to process video signals from thesurgical file device12 and supply the signals to the monitor orvideo display34. TheCPU32 has a printer port to interface it with the color printer.
• The display monitor34 can comprise any one of a number of suitable commercially available monitors. In one embodiment, thedisplay34 is a 17-inch (43 cm) liquid crystal display (LCD) monitor.
• Thestorage cabinet22 includes a substantially vertical pole orrod38 to support themonitor34. The height and tilt angle of thedisplay34 is adjustable to allow suitable viewing for the operating surgeons. In one embodiment, themonitor34 is positioned at a height of about 1.5 meters (5 feet). As discussed further below, themonitor34 can display a magnified visual picture of the view from the distal end of the cuttingtip assembly18.
• Thecabinet22 includes one or more hooks or supports42 for mounting of an irrigation fluid bag, container orpouch44. Thehooks42 can be positioned at a suitable position, for example, on thepole38. Theirrigation bag44 is provided sterile irrigation water from asource46 through afeedline48. The sterile water is transported to the distalcutting tip assembly18 during device operation throughfeed line50.
• In one embodiment, sterile water is provided to the distalcutting tip assembly18 through thecontrol unit24 viafeedline50a.In a modified embodiment, the sterile water is provided directly to the distalcutting tip assembly18 viafeedline50b.
• Thecontrol unit24 is supported at a suitable working height by thecabinet structure22. Thecontrol unit24 is operatively interfaced or connected thecable16 at itsproximal end40. In the illustrated embodiment, thecable16 connects to afront face52 of thecontrol box24. Thecontrol box24 and theCPU32 can be housed in a single unit.
• Thecontrol unit24 and thecomputer system26 are powered by a conventional 115-Volt ACelectrical power supply54, for example, by connecting a male plug to a wall receptacle. In modified embodiments, the system may be powered by a portable power supply such as a generator and the like.
• In one embodiment, thecontrol unit24 connects to a pressurized gas orair source supply56 viafeedline58. As discussed further below, the pressurized gas is used to power an air turbine motor of thepowered handpiece20. The pressurized gas is supplied by the hospital or house supply. In modified embodiments, a portable pressurized gas source such a cylinder may be efficaciously used, as needed or desired.
• In one embodiment, the pressurized gas and the irrigation water are supplied from thecontrol unit24 and through theumbilical cable16 to thesurgical file device12. In addition, thecable16 provides video signals from thesurgical file device12 to thecontrol unit24 andcomputer system26. Theumbilical cable16 provides a mechanical and waterproof connection for electrical, video, pressurized gas and irrigation water supply. In modified embodiments, one or more of the electrical and video signals, gas and water may be transmitted through separate cables with efficacy, as needed or desired.
• Thecable16 can be any suitable length, for example, about 16 feet long. Thecable16 is sterilizable. Thecable16 may also be used to provide a suction line, as needed or desired.
• Thecontrol box24 houses switches and valves to control the flow of the pressurized gas and irrigation water. Thecontrol unit24 has electrical controls for thehandpiece20 and video signals for thecomputer system26. Thecontrol unit24 may also include sensors such as pressure sensors, flow rate sensors and the like to monitor the flow of the pressurized gas and irrigation water.
• Software is provided that interfaces with thecontrol unit24 to monitor and control system operation and perform various other related functions. For example, the software allows the operating room personnel to enter the patient identification and date and other pertinent data into the computer for record reference.
• The software also allows operating room personnel to change video picture zoom ratios and to control and modify details of the picture for clarity. The computer-based system enables the operating personnel to save pictures of the patient's anatomy, including before and after pictures, to a computer file and to print out color pictures in seconds.
• The software is used to control the pressurized gas and irrigation liquid flow to thesurgical file device12. The software can also be used to turn thedevice12 on and off and control the frequency of cutting blade reciprocation during filing procedures.
• Thecontrol unit24 accommodates connection to existing cauterizing equipment. As discussed further below, and as shown in phantom inFIG. 1, thecontrol unit24 can be connected to acauterizing system60 throughconnection line61 to stop or prevent undesirable bleeding during surgery.
• In brief, to enable the surgeon to stop the bleeding of freshly cut bone tissue, the cutting blade surface can feature an electrically conductive surface that is operatively connected to an electric circuit, for example,60. This allows a controlled pulse of electricity to generate a small amount of heat applied directly onto the bone surface to coagulate the blood and stop the bleeding at the freshly cut bone surface only, while insufating delicate nerve roots from unwanted heat damage. The irrigation water also works in conjunction to assist in keeping heat precisely localized and preventing heat injury to the nearby delicate nerve roots and spinal cord.
• FIG. 3 shows thesurgical file device12 with adistal tip assembly18 having a generally curved and/or angled configuration.FIG. 4 shows thesurgical file device12 with adistal tip assembly18′ having a generally straight configuration. Thepowered handpiece20 has at its proximal end62 a quickconnect docking feature64 to enable connection to theumbilical cable16 that provides a mechanical and waterproof connection for electrical, pressurized gas and irrigation water supply.
• FIG. 5 shows thesurgical file device12 connected to theumbilical cable16 at itsdistal end66. The interface or connection between aproximal end330 of thepowered handpiece18 and thecable16 includes a cover orhousing68. In the illustrated embodiment, thecover68 is generally frusto-conical in shape, though in modified embodiments other suitable shapes such as cylindrical and the like may be efficaciously utilized, as needed or desired.
• Thedistal tip assembly18 at its proximal portion or end70 includes a cover orhousing72. In the illustrated embodiment, thecover72 is generally frusto-conical in shape, though in modified embodiments other suitable shapes such as cylindrical and the like may be efficaciously utilized, as needed or desired.
• Thepowered handpiece20 includes acover74 intermediate the front and back covers68 and72. In the illustrated embodiment, thecover74 is generally cylindrical in shape and can include a longitudinally extending bulgingportion76 for housing a video camera. In other embodiments, thecover74 may be efficaciously contoured in suitable ergonomic shapes that facilitate operation by a surgeon or other operator.
• Thecovers68,72,74 can be formed from a number of suitably durable materials. In one embodiment, thecovers68,72,74 are formed from a suitable plastic such as a thermoplastic. In another embodiment, thecovers68,72,74 are formed from a suitable metal such as stainless steel. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Thecovers68,72,74 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
• FIG. 6 shows a partially exploded view of thesurgical file device12. As discussed further below, thepowered handpiece20 includes avideo camera78 and a micro-motor80 that provides rotary motion which is converted to linear reciprocating motion within thedistal tip assembly18.FIG. 7 shows another perspective view of thesurgical file device12 with thedistal cover72 removed illustrating some of the features of the distal tip assembly.
• Distal Tip Assembly
• FIGS. 8 and 9 show thedistal tip assembly18 in greater detail. In one embodiment, thecomposite tip18 has a length of about 10 cm (4 inches) to about 15 cm (6 inches), including all values and sub-ranges therebetween. In one embodiment, thecomposite tip18 has a length of about 5 cm (2 inches) to about 30 cm (12 inches), including all values and sub-ranges therebetween. In modified embodiments, other suitable lengths may be efficaciously utilized, as needed or desired.
• Thedistal tip assembly18 is sterile to maintain appropriate surgical standards and is provided in a sterile packaging. In one embodiment, thedistal tip assembly18 is for one time use and is disposable thereafter. As described further below, embodiments of thedistal tip assembly18 include a cartilage or other tissue and bone removal file with vision, illumination, irrigation and cauterization features.
• Thedistal tip assembly18 generally comprises adistal tip portion92 that has adistal-most end94 and a proximal portion extending into thecover72 that encloses ahousing96 that receives a toroidalpower converter system98 and a water pump system. Thedistal tip assembly18 further includes aninterface member102 and acoupling104 that facilitate connection between thedistal tip assembly18 and thepowered handpiece20.
• In some embodiments, thedistal tip portion92 generally comprises a reciprocating cutting orfiling blade106 that is enclosed in a protective case orshield108. Theshield108 has an aperture, window, opening112 to expose acutting surface114 of thefiling blade106 proximate thedistal end94. Desirably, the shieldedblade106 permits surgical bone and/or tissue removal substantially without risk of damage to nearby delicate tissues such as nerve tissue.
• Thedistal tip portion92 can be configured to be small and thin so it is minimally intrusive and can go around corners and into any small inaccessible blind channels where nerves are located. Thedistal tip portion92 can be configured to fit any desired cavity or contoured shape. Thetip portion92 can be supplied in a variety of sizes and shapes to suit a particular application such as, but not limited to, neurosurgery, orthopaedic surgery and plastic surgery.
• Theblade cutting surface114 can be located on the end of an extension with abend116 of any desired angle. In the illustrated embodiment ofFIGS. 8 and 9, thetip portion92 has a curved, angled or bent configuration with thebend116. In another embodiment, thedistal tip portion92 has a substantially straight and/or planar (flat) configuration.
• Thetip portion92 further includes alinear bearing retainer118 within theshield108. Thereciprocating blade106 is precision fitted within the bearingretainer118 that allows free linear motion of the reciprocation blade stroke. Advantageously, the bearingretainer118 provides low friction bearing surfaces for the reciprocating motion of theblade106.
• The bearingretainer118 comprises a plurality of stationarylinear bearings120 which are positioned on the top, bottom and both sides of the reciprocation blade. The toplinear bearing120 has an aperture, opening orwindow122 that is substantially aligned with theshield aperture112 to expose the blade-cuttingsurface114. In one embodiment, the tip portion92 (and hence the lengths of theblade cutting surface114 and theapertures112,122) are configured so that substantially the entireblade cutting surface114 is exposed during the full blade reciprocation cycle.
• The bearingretainer118 can be formed from a number of suitably durable materials. In one embodiment, the bearingretainer118 is formed from a suitable plastic such as a thermoplastic. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• The bearingretainer118 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
• As described in more detail below, thedistal tip portion92 further includes a pair of fiber optic probes124,126 that are part of an on-board optical illumination and vision system. The fiber optic probes124,126 optically connect or interface at their proximal ends to thevideo camera78.
• The bottom or lowerfiber optic probe124 is below thelower bearing120. Thefiber optic probe124 may be housed within theshield108 or it may have its independent protective jacket below theshield108. Thefiber optic probe124 has adistal end128 at about thedistal-most end94 of thetip portion92.
• The top or lowerfiber optic probe126 is above theupper bearing120. Thefiber optic probe126 may be housed within theshield108 or it may have its independent protective jacket above theshield108. Thefiber optic probe126 has adistal end130 proximal to aproximal end132 of theaperture112 and/or the cuttingsurface114.
• Theshield108 can include theaperture112 on any one of its sides depending on the positioning of the cuttingsurface114. This includes the top (as shown in, for example,FIGS. 8 and 9), the bottom and the sides of theshield108 and even itsdistal end134. Theshield108 has a longitudinally extending cavity that houses theblade106, the bearingretainer118 and in some embodiments the fiber optic probes124,126. In the illustrated embodiment, thedistal end134 closes the longitudinal shield cavity.
• In one embodiment, theshield108 is capable of deflecting and bends at predetermined and/or low loads (for example about 2 lbs.) in order to prevent injury or damage to tissue, such as nerve tissue, engaged by theshield108. Theshield108 has a predetermined stress-strain curve and spring constant to provide the desired deflection and can comprise, for example, a suitable polymer and the like. Theshield108 may bend at thebend location116 or at a location proximate to the contact with the tissue. One or more of the associatedtip portion92 components such as theblade106,bearings120 and the fiber optic probes124,126 can also bend with theshield108, as needed or desired.
• Theshield108 can be formed from a number of suitably durable materials. In one embodiment, theshield108 is formed from a suitable plastic such as a thermoplastic. In another embodiment, theshield108 is formed from a polymer that is flexible or can bend under a predetermined load. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Theshield108 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
• Theshield108, the bearingretainer118 and the fiber optic probes124,126 generally conform in shape to the longitudinal profile of theblade106. In the illustrated embodiment ofFIGS. 8 and 9, this is a curved, angled or bent profile with a bend at around116.
• FIG. 10 shows a cross-sectional view of thedistal tip portion92 at a location proximal to theaperture112 and thebend116. Theblade106 is substantially centrally located within the shield orouter jacket108. Theblade106 is precision fitted within the bearingretainer118 including thelinear bearings120. The respective lower and upper fiber optic probes124,126 are buffered from theblade106 by thestationary bearings120.
• The cutting bladelinear bearing120 has a series ofshallow slots190 running substantially longitudinally in line with the proximal to distal axis. Theslots190 serve as water passageways to enable irrigation water to be transported from a proximal to a distal location. The irrigation water serves several functions and provides several advantages.
• The water is a lubricant for the interface between the movingblade106 and the stationarylinear bearings120, which in one embodiment are positioned on the top and bottom and both sides of thereciprocation blade106. The water cools the blade and bearing material, and in the embodiment the bearing material is plastic, prevents the plastic bearing material from getting hot and softening. The water also serves to wet the cutting blade surface. The water is also used to clean tissue and transport the cut tissue away from thecutting blade106. Additionally, water transported across thelinear blade106 intimately irrigates the volume of water in the distal blade area to clear the optical vision field for clear viewing.
• FIG. 11 shows a cross-sectional view of thedistal tip portion92 at theshield aperture112. The cuttingsurface114 of theblade106 is exposed and is above thelower bearing120, the lowerfiber optic probe124 and alower portion192 of theshield108. The drawing also shows portions of theshield108 and theupper bearing120 at the tipdistal end94. In this embodiment, the cross-sectional profile of the cuttingsurface114 is convex and the associated portions of theshield108,bearings120 and lowerfiber optic probe124 generally conform to this shape.
• In one embodiment, and as described further below, thetoroidal drive system98 is substantially mounted within thehousing96 and generally comprises arotatable toroid drive136 and adrive slide138. Adrive shaft140 is connected to thehandpiece motor80 and transfers rotary motion to the toroid drive136 which engages thelinear slider138 to convert rotary motion into reciprocating motion that is provided to theblade106 for performing bone and/or tissue removal operations. In modified embodiments, other suitable rotary to reciprocating motion mechanisms or devices may be used, as needed or desired, to reciprocatingly drive theblade106.
• As discussed further below, thedrive shaft140 is connected to thetoroid drive136 and has a specially designed female receptor hole. The receptor hole allows thedrive shaft140 to substantially irrotationally mate with a power drive shaft of themotor80.
• Thehousing96 has adistal end142 and aproximal end144 and a generally flat recessedsurface146 extending from thedistal end142 towards theproximal end144. Thelinear slide138 is reciprocatingly seated on or within the recessedsurface146. Thehousing96 includes acavity148 intermediate the recessedsurface146 and the housingproximal end144 that receives therotatable toroid drive136. The housingproximal end144 has anopening149 that receives a power shaft of thehandpiece motor80 that connects to thedrive shaft140.
• Thehousing96 can be formed from a number of suitably durable materials. In one embodiment, thehousing96 is formed from a suitable plastic such as a thermoplastic. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Thehousing96 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired. Thehousing96 and bearingretainer118 may comprise an integral unit, for example, they may be formed by molding and the like.
• Thetoroid drive136 is connected with thedrive shaft140. Thetoroid drive136 has anouter rim150 that is engaged with theslider138 and transmits rotary motion that is converted into reciprocating motion by theslider138.
• Theslide plate138 has adistal end152, aproximal end154 and a specially contouredslot156 proximate to theproximal end152 with a pair of generally opposed bearing surfaces164,166. As described in greater detail below, theslot156 receives the rotatingouter rim150 of thetoroid drive136.
• Theblade106 is connected to theslide138. As described in greater detail below, this connection utilizes shear pins to provide a safety mechanism against blade buckling.
• Theslide138 can be formed from a number of suitably durable materials. In one embodiment, theslide138 is formed from a suitable plastic such as a thermoplastic. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Theslide138 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
• Theinterface member102 has anopening158 which allows passage of the fiber optic probes124,126 for connection to thecamera78. Theinterface member102 has anopening160 that receives that receives a power shaft of thehandpiece motor80 that connects to thedrive shaft140.
• Thecoupling104 has anopening162 that receives that receives a power shaft of thehandpiece motor80 that connects to thedrive shaft140. Theopenings149,160 and162 are substantially aligned with one another.
• Theinterface member102 andcoupling104 can be formed from a number of suitably durable materials. In one embodiment, theinterface member102 andcoupling104 are formed from a suitable plastic such as a thermoplastic. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Theinterface member102 andcoupling104 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
Blade Embodiments
• Embodiments of the invention provide reciprocating cutting blade for precision bone and/or tissue removal. In one embodiment, the reciprocating cutting blade is shielded or covered or guarded on five sides to provide a shielded surgical file. As used herein, the term “blade” is a broad term and includes, without limitation, any of various grinders, filers, cutters, surfaces that are configured to grind, file, and/or cut tissue.
• The shielded file can be flat, planar, convex or concave in its cross-section. The shielded file can extend generally straight or be curved, angled or bent along its longitudinal axis. Advantageously, the angled configuration allows the cutting surface to travel around a corner to reach into usually inaccessible body cavities. Desirably, this provides the ability to remove unwanted tissue in a blind tunnel or body cavity while enabling direct vision through the illumination and vision probes.
• The shielded file can be dimensioned in a number of manners. The shielded file can be any length or width suitable for the human or mammalian anatomy proportions. For other non-medical applications, the shielded file can be of any length or width to suit the material removal application.
• The thickness of the shielded file can be varied to be very thin. In one embodiment, the thickness can be of the order of 1/10^thof an inch. Advantageously, this enables the shielded file to fit into small spaces such as between a nerve and the foramen opening that it is passing through. In other embodiments, the thickness of the shielded file can be greater, as needed or desired.
• The cutting blade can be shaped and contoured in several configurations. In one embodiment, the reciprocating cutting blade is straight and planer (in one flat plane). In another embodiment the reciprocating cutting blade that is curved convex or concave in its cross sectional shape. In yet another embodiment, the reciprocating cutting blade that is substantially straight in its longitudinal axis. In still another embodiment, the reciprocating cutting blade is curved in its longitudinal axis.
• The thickness of thecutting blade drive106 can be varied. In one embodiment, the cutting blade thickness is in the range from about 100 microns or μm (0.004 inches) to about 300 μm (0.012 inches). In another embodiment, the cutting blade thickness is in the range from about 50 μm (0.002 inches) to about 600 μm (0.024 inches). In yet another embodiment, the cutting blade thickness is in the range from about 25 μm (0.001 inches) to about 2.5 mm (0.1 inches). In modified embodiments, other suitable dimensions may be efficaciously utilized, as needed or desired.
• Thecutting blade106 can be formed from a number of suitably durable materials. In one embodiment, thecutting blade106 is formed from steel. In another embodiment, thecutting blade106 comprises spring stainless steel. In modified embodiments, other suitable metals, alloys, plastics, ceramics, hard carbon (e.g., graphite, diamond, etc.), composites, laminates, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Thecutting blade106 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
• In one embodiment, thecutting blade106 is flexible. Advantageously, this allows the cutting blade to be easily bent, angled or curved along its length as it is enclosed in a bent, angled or curvedouter shield108. In another embodiment, the cutting blade is substantially rigid. This can be suitable for blade configurations that are generally straight. The rigid blade may also be bent by suitable techniques, as needed or desired. In modified embodiments, thecutting blade106 may efficaciously comprise one or more flexible portions and one or more rigid portions, as needed or desired.
• FIG. 12 shows an embodiment of thecutting blade106. Theblade106 comprises a thin flexible material that is capable of bending along its length. Theblade106 includes a distal section or,portion194 with the cuttingsurface114, a medial section orportion196 and a proximal section orportion198. When enclosed within the curved, angled orbent shield108 theblade106 flexes like a thin spring to conform to the shape of the shield or guidecover108. Thus, themedial section196 is curved, angled or bent while the respective distal andproximal sections194,198 extend generally straight.
• FIG. 13 shows a cross-section of a cutting surface114aand an associatedportion202aof theshield108ahaving a generally convex configuration suited for some particular bone and/or tissue removal applications. The convex curvature of the cutting surface114acan also be advantageous in providing enhanced rigidity to the thin cutting surface114aand/or the associatedblade106.
• FIG. 14 shows a cross-section of a cuttingsurface114band an associated portion202bof theshield108bhaving a generally concave configuration suited for particular bone and/or tissue removal applications. The concave curvature of the cuttingsurface114bcan also be advantageous in providing enhanced rigidity to thethin cutting surface114band/or the associatedblade106.
• FIG. 15 shows a lengthwise-section of thedistal tip portion92 having a cuttingsurface114con the top or upper side of thereciprocating blade106 within thenon-moving shield108. This configuration is suited for some particular bone and/or tissue removal applications. Thebend116 allows the cuttingsurface114cto pass into a cavity that involves traveling around a corner. The direction of blade travel is generally denoted byarrows204.
• FIG. 16 shows a lengthwise-section of thedistal tip portion92 having a cuttingsurface114don the bottom or lower side of thereciprocating blade106 within thenon-moving shield108. This configuration is suited for some particular bone and/or tissue removal applications. Thebend116 allows the cuttingsurface114dto pass into a cavity that involves traveling around a corner. The direction of blade travel is generally denoted byarrows204.
• FIG. 17 shows the cuttingsurface114 including an abrasive material orabrasives206 for cutting, removing, filing or grinding bone and/or tissue materials. For clarity, one side of theshield108 has been removed in the drawing. Any one of a number of suitable abrasives may be used that are safe to use within a patient's body or are biocompatible and hard. In one embodiment, theabrasives206 comprise embedded diamonds or diamond particles.
• Also shown inFIG. 17 is a lateral slot or opening at the tip portiondistal end94. Advantageously, thedistal opening208 allows the removal of any bone and/or tissue debris that may collect within the distal and provides for flushing out of the debris as theblade cutting surface114 reciprocates and the irrigation fluid flows out of the instrument.
• FIG. 18 shows theblade cutting surface114 including a plurality of micro holes oropenings212 for the flow of irrigation fluid therethrough. For clarity the abrasives are not shown in the drawing. Theholes212 are in fluid, liquid or hydraulic communication with thelongitudinal slots190 of the lowerlinear bearing120. Theslots190 of the upperlinear bearing120 also provide irrigation water to the cutting area.
• FIG. 19 schematically depicts the fluid, liquid or hydraulic communication between the bearing slot(s)190 and the cutting surface holes212. The flow of water from the bearing slots(s)190 and themicro hole openings212 is generally indicated byarrows214. The water is forced to flow up, down or out through theopenings212 in thecutting blade surface114 and away from theblade cutting surface114. The water washes away cut material and keeps debris from clogging the cuttingsurface114 to maintain optimum cutting and material removal performance, and to keep the cutting area cool to prevent tissue necrosis damage.
• The water also flows over the moving (reciprocating)cutting blade106 and drive mechanism orbearings120 to provide cooling and lubrication. The water can be forced into the cuttingcavity112 to flush away micro cutting debris and maintain a clear field of view for video navigation and visualization. The water can be forced into the cuttingarea cavity112 to clean and remove freshly cut bone cells and bone fragments to prevent repopulation and unwanted bone growth in the area.
• FIG. 20 is another schematic depiction showing the fluid, liquid or hydraulic communication between the irrigation fluid holes212 and thebearing irrigation passageways190. The drawing also shows the abrasive material orabrasives206 of theblade cutting surface114.
• FIG. 21 shows the reciprocation blade stroke direction as generally indicated byarrows216. The free linear motion of the reciprocation blade stroke is a linear stroke. In one embodiment, for applications within the human body, the linear stroke is in the range from about 2.5 mm (0.1 inches) to about 7.6 mm (0.3 inches), including all values and sub-ranges therebetween. In another embodiment, the linear stroke is in the range from about 1.3 mm (0.05 inches) to about 12.7 mm (0.5 inches), including all values and sub-ranges therebetween. In yet another embodiment, the linear stroke is in the range from about 0.25 mm (0.01 inches) to about 25.4 mm (1 inch), including all values and sub-ranges therebetween. In modified embodiments, the linear stroke may efficaciously be lower or higher depending on the particular application, as needed or desired.
Cauterization
• In accordance with one embodiment, thesurgical file instrument12 can stop the small amount of bleeding of freshly cut or sculpture shaped bone or other tissue by accommodating connection to existingcauterizing equipment60. In this embodiment, the special feature the system has is a non-electricallyconductive shield108, which is covering an electrically conductivemetal file blade106.
• When bleeding of the freshly cut bone is detected, thefile cutting blade106 can be brought back into contact with the freshly shaped bone that may be bleeding slightly. A pulse of electricity can be momentarily applied that will flow from the metal blade file surface into the bleeding bone or other tissue surfaces. This will heat the bleeding bone or other tissue surfaces, coagulate the blood flow and advantageously stop the bleeding of the bone and/or tissue surface. Desirably, the irrigation flow facilitates localizing the heat and cooling while theshield108 protects the adjacent nerves and spine from heat.
Illumination and Vision Probes
• FIG. 22 shows a fiberoptic vision system218 including the fiber optic probes124 and126. The fiberoptic vision system218, in some surgical embodiments, enables surgeons to visually see and verify the presence of unwanted bone and cartilage buildup that is causing nerve root compression and damage to normal body functions. This information on the unwanted material can be documented and recorded by saving visual pictures into a computer database and printing color pictures immediately for reference and record.
• The lowerfiber optic probe124 includes a plurality ofoptical fibers220athat optically terminates at a distal lens array orarrangement222a.Thelens array222ais positioned at substantially the tipdistal end94. Thefiber optic probe124 may be placed within theshield108 or it may have a separate housing. The lowerfiber optic probe124 generally follows the longitudinal profile of thedistal tip portion92, theblade106 and/or theshield108.
• The upperfiber optic probe126 includes a plurality ofoptical fibers220bthat optically terminates at a distal lens array orarrangement222b.Thelens array222bis positioned proximal to theblade cutting surface114. Thefiber optic probe126 may be placed within theshield108 or it may have a separate housing. The upperfiber optic probe126 generally follows the longitudinal profile of thedistal tip portion92, theblade106 and/or theshield108.
• Advantageously, the fiberoptic vision system218 enables visual viewing of the patient's body cavities all during insertion and placement of the cutting blade. This is intended to enable the surgeon to safely navigate the tiny body cavities such as neuroforamina and other tubular canals, and avoid damage to fragile nerve roots.
• FIG. 23 shows theoptical fibers220ain more detail. The upperoptical fibers220b(220b′,220b″) have a similar configuration and functioning though they may have a different curvature or be flat and planar. Theoptical fibers220acomprise a central plurality ofoptical vision fibers220a′ flanked by light orillumination fibers220a″. Theoptical vision fibers220a′ are connected at their proximal end to thevideo camera78.
• The fiberoptical illumination fibers220a″ illuminate the body cavity and enable video visualization. An LED located at the proximal end of the fiberoptics illumination fibers220a″ is used transmit light to the distal end of theillumination fibers220a″ to provide illuminating light. Advantageously, the direct visionoptical system218 enables surgeons to safely navigate into blind cavities of the human body and to illuminate and see specific body anatomy such as nerves and bony buildups that could be irritating and pressing against nerves causing nerve compression.
• In the illustrated embodiment, the direct visionoptical system218 desirably provides an integrated illumination and optical vision system. The optics for vision and illumination are included within thedistal tip assembly18 which in some embodiments is a docking sterile one time use assembly.
• Referring in particular toFIG. 24, the distal opticalsystem lenses arrangements222aand222bare each arrayed in three segments. The loweroptical segments222aare arranged with avideo imaging lens222a′ centered medially and with illuminatinglenses222a″ positioned on the right and left lateral sides. The upperoptical segments222bare arranged with avideo imaging lens222b′ centered medially and with illuminatinglenses222b″ positioned on the right and left lateral sides.
• FIG. 25 shows thelens arrays222a,222bin more detail. The lateral sides of thecentral lenses222a′,222b′ have a respective semi-arc male shape224a′,224b′ to each of their left and right sides. The illuminatinglenses222a″,222b″ are shaped to have mating female semi-arcmedial sides226a″,226b″ on there medial sides which mate into the male mating features224a′,224b′ of the central lens sides.
• Advantageously, suchmating lens arrays222a,222bcan accommodate a wide range of instrument sizes while using substantially the same basic lens assembly design. Different lenses may be used in the design and the curvature of the lens array adjusted and changed to provide the desired illumination and/or field of view. For example, for a particular medialvideo imaging lens222a′,222b′ the curvature of theside illuminating lenses222a″,222b″ can be adjusted or changed to illuminate the desired field of view. This desirably saves on cost since micro lenses are very expensive to tool up and make. Thedistal tip assembly18 can have numerous sizes with varying cross sections of thedistal tip portion92 depending on the particular application and advantageously substantially the same basiclens assembly design222a,222bcan be utilized with the different sizes.
• Additionally themating lenses222a′,222b′ and222a″,222b″ allow the black out of the respective mating surfaces224a′,224b′ and226a″ and226b″ to substantially prevent illumination light from passing laterally into theimaging lens222a′,222b′ and degrading the optical quality of the resulting picture. A lens set comprising thecentral imaging lens222a′,222b′ and one each right and left illuminatinglenses222a″,222b″ can be assembled onto a wide range of instrumentdisposable cutting tips18 in an assembly that has an optical distal lens system which is very thin in cross section and that the lenses follow the instrument cross sectional curve. Advantageously, for embodiments of the invention and in particular the neurosurgery embodiments, having a very thin cross section enables the instruments distal tip to fit into the tiny space between a nerve root and its neuroforamen opening.
• As shown inFIG. 26 the images from the direct visionoptical system218 can be viewed on theLCD monitor34. The drawing shows an example of the display with aview228 from the upper fiberoptic126 looking onto theblade106 and aview230 from the lower fiberoptic124 looking out from the instrumentdistal end92.
Toroidal Transmission System
• The toroidal transmission orpower conversion system98 is a mechanical conversion device that converts rotary to reciprocating motion or action. Thepowered handpiece20 houses arotating motor80 to power the cutting action of the tissue removal instrument orblade106. The rotating mechanical action of themotor80 is converted into reciprocating mechanical motion of a suitable reciprocal stroke length. It is desirable that the mechanical motion conversion device be simple and have few parts.
• Having a video camera system mounted directly into a reciprocating motion mechanical device can create a stability problem with respect to inherent vibration that is usually inherent in all reciprocating motion mechanical devices. Advantageously, thetoroidal drive system98 of embodiments of the invention provides a desirable solution for the vibration problem since it has low or minimum levels of associated vibration. This advantageously provides a stable platform for the capture of high quality pictures by the video system including thecamera78 housed in thehandpiece20.
• Thetoroidal drive system98 inherently has few parts and can be built to be very low vibration due to low mass of the reciprocating components. Thus, thetoroidal drive system98 can provide thepowered handpiece20 with a stable platform and a smooth running mechanical action. The transmission system of embodiments of the invention has utility in a number of fields and applications where conversion of rotary motion to reciprocating motion is desired.
• FIGS. 27 and 28 show thetoroid drive136 and the femalereceptor drive shaft140. In one embodiment, thetoroid drive136 and thedrive shaft140 comprise an integral unit and are formed as a single piece. In another embodiment, thetoroid drive136 and thedrive shaft140 can be rigidly connected to one another.
• Thetoroid drive136 and thedrive shaft140 can be formed from a number of suitably durable materials. In one embodiment, thetoroid drive136 and thedrive shaft140 are formed from a suitable plastic by molding. The plastic material may comprise a suitable thermoplastic. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Thetoroid drive136 and thedrive shaft140 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
• Thetoroid drive136 and thedrive shaft140 are rotatable about a substantiallycentral rotation axis232. Thetoroid drive136 has a generally circular orcurvilinear cam portion234 and a generallycentral shank portion236. As discussed further below, thecam234 has a specially designed generally circular or curvilinearouter rim150 with a varying or non-uniform thickness.
• Thecam234 and/or theouter rim150 have a substantially centralside view plane238. Thecam234 and/or theouter rim150 are tilted relative to a vertical plane oraxis240 by a predetermined angle α and hence to the rotation axis by an angle β where β=90°−α. Thus, typically β and α are less than 90°.
• In one embodiment, α is about 20° and β is about 70°. In another embodiment, α is in the range from about 10° to about 40° and β is in the range from about 50° to about 80°, including all values and sub-ranges therebetween. In yet another embodiment, α is in the range from about 5° to about 80° and β is in the range from about 10° to about 85°, including all values and sub-ranges therebetween. In modified embodiments, α and β may be lower or higher, as needed or desired.
• As schematically illustrated inFIG. 29, in one embodiment, thecam234 and/or theouter rim150 are designed to provide a variable thickness for theouter rim150 by the partial superimposition of two toruses ortoroids242,244 of substantially uniform rim thickness with respectivecentral axes246,248. By controlling the degree of superposition, therim150 of variable and controlled thickness is created. Thus, the transmission orpower conversion system98 is also referred to as a “hybrid dual or twin toroid” system.
• Advantageously, theouter rim150 thickness is varied such that therim150 substantially continuously contacts the bearing surfaces164 and166 as thecam234 rotates about thecentral axis232. Thus, desirably the twosurfaces164 and166 can remain at a substantially fixed distance apart as they move linearly back and forth in reciprocating motion in response to the cam's rotation about thecentral axis232.
• In the illustrated embodiment, the toruscentral axes246,248 are at an offset angle θ to produce the desiredvariable thickness rim150. The slightly dimpled orgrooved surface250 is indicative of the partial superposition of the two toruses ortoroids242,244. In modified embodiments, more than two toruses and/or toruses with variable rim thickness may be utilized to create the desired outer rim profile.
• Advantageously, the dual torus or toroid (one toroid partially inside another) configuration provides an elegant solution of for maintaining a uniform distance between the bearingsurfaces164,166 or driven rollers. The rotation of the toroid ortorus cam234 moves theouter rim150 in a reciprocating motion with the motion being generally parallel to therotary axis232. The reciprocating motion of theslide plate138 is also generally parallel to therotary axis232 which is then transmitted to theblade106.
• FIG. 30 shows the thickness profile of theouter rim150 in accordance with one embodiment. The thickness varies across therim150 in a generally offset sinusoidal profile with a minimum thickness T_minand a maximum thickness T_max. In modified embodiments, other suitable rim thickness profiles may be efficaciously utilized, as needed or desired.
• The disposablecutting blade assembly18 includes theintegrated transmission system98 within thedistal cover72. Thetransmission system98 converts the rotary motion of thedrive motor80 into the reciprocating motion of the tissue-cutting blade106. Thetransmission system98 is a sterile assembly of the disposablecutting blade assembly18 that is sterile packaged.
• Thetransmission system98 is an internal mechanism and is generally housed within thehousing96. This is important in that the “one time use disposable”tip assembly18 embodiments because easy separation from the re-sterilizable motor drive portion of thepowered handpiece20. In theses embodiments, thepowered handpiece20 with itsrotary motor80 comprises an independent assembly from the disposable distalcutting tip assembly18. Numerous sizes and shapes of distalcutting tip portion92 are available to be connected onto the motor drive poweredhandpiece20.
• Since the disposable distalcutting tip assembly18 has an internal mechanism to convert rotary motion into reciprocating motion, it advantageously enables a simple and cost effective means of disconnecting the twoassemblies18 and20. Thedrive shaft140 at itsproximal end253 includes afemale receptor hole254 that is configured to substantially irrotationally mate with a matching male distal shaft drive protruding out of themotor drive80.
• FIG. 31A shows a simple femaletriangular hole254ain thedrive shaft140 that can engage a triangular shaped distal shaft drive protruding out of the motor drive assembly. When thedistal tip assembly18 and thepowered handpiece20 are connected both the femaletriangular receptor hole254aand the motor's male triangular drive shaft can rotate in tandem. The male and female features are free to mesh and align during the axial motion of connecting the disposablecutting tip assembly18 onto the reusablesterilizable motor handpiece20.
• A triangular shaped male mating drive is desirable because it facilitates sterilization of the male triangular shaft. The surfaces that are steam sterilized and reused are desirably simple surfaces that are easy to wash and clean. The surfaces should also enable reliable cleaning prior to sterilization. A triangular male shaft has three flat surfaces that are both easy to see and clean.
• In modified embodiments, other suitable male-female mating drive polygonal or non-polygonal interlocking configurations may be utilized with efficacy, as needed or desired. For example,FIG. 31B shows a generally square or rectangularfemale receptor hole254bandFIG. 31C shows a generally hexagonalfemale receptor hole254c.
• FIG. 32 and33 show thecutting blade106 and thedrive slide138. Theouter rim150 of thetoroid drive136 engages theslide slot156 and abuts against the bearing surfaces164,166 as it rotates to reciprocatingly displace theslide138 connected to theblade106. Theslide138 can be generally above the toroid drive136 or it can be generally below thetoroid drive136. In modified embodiments, theslide138 can be to the sides of thetoroid drive136 as long as theouter rim150 rotates within theslide slot156 and causes the slide to move in a reciprocating motion.
• It is important that thedistal filing blade106 maintain its structural rigidity and not to fail in a buckling mode that would cause thefile blade106 to become bent or distorted into a shape that may result in an undesirable thicker profile. To safeguard against this, in one embodiment, a safety shear system is provided.
• Theslide138 includes a pair of posts or pins260,262 that engage respective blade holes256,258. In one embodiment, theposts260,262 are formed from a molding process in which theslide138 including theposts260,262 comprises a plastic. Theposts260,262 in one embodiment are heat staked and the like to mushroom and formrespective heads264,266 to affix theblade106 and theslide138. The mushroomed pins260,262 prevent undesirable blade buckling by being configured to shear at a force much lower than the force that could potentially buckle thefile blade106.
• Thus, advantageously, thefile blade106 is driven by a structure that has an intentional weak point that will shear away the driving reciprocating action of theblade drive106 to prevent a potentialdistal blade106 buckling. The configuration of the shear pins260,262 is tailored to the specific file blade configuration (which varies in width and length and cross sectional curve). Thus, the shear pin connection including the diameter and/or cross-section of the mushroomed heads264,266 and/or the shank portions of thepins260,262 is configured such that the mushroomed pins260,262 shear at a force lower than a force that would buckle the specificdistal cutting blade106 and allow safe disengagement and disconnection of theblade106 from theslide138.
• Advantageously, the diameter(s) of thepins260,262 provides a desirable shear pin safety mechanism. Thepins260,262 allow the connection between thedrive slide138 and theblade106 to shear at a predetermined force. This force can be determined for a particular cutting blade configuration by a number of methods including modeling, numerical analysis, computer simulation, experimental and empirical testing and the like, among others. Accordingly, eachdiffering cutting blade106 is provided with a shear connection feature to shear and stop the blade driving action before the blade could conceivably buckle. Aclearance space268 in theslide138 is provided in the proximal direction behind a bladeproximal end270 to allow theblade106 to move proximally in theslide part138 when shear disconnection occurs so that theblade106 is substantially decoupled from the reciprocating motion.
• The safety shear force F_shearcan be calculated as a function of the blade buckling force F_bucklein a number of ways to provide suitable protection. In one embodiment, the shear force F_shearis about ⅓^rdof the blade buckle force F_buckle. In another embodiment, the shear force F_shearis in the range from about 0.25F_buckleto about 0.75F_buckle, including all values and sub-ranges therebetween. In yet another embodiment, the shear force F_shearis in the range from about 0.1F_buckleto about 0.9F_buckle, including all values and sub-ranges therebetween. In modified embodiments, the shear force F_shearmay be lower or higher, as needed or desired.
• FIGS. 32 and 33 illustrate a connection between theblade106 and theslide plate138 in accordance with an embodiment that provides a safety shear decoupling between the106 and theslide plate138. In modified embodiments, as the skilled artisan will appreciate, theblade106 and theslide138 may be connected utilizing other suitable techniques, as needed or desired.
• FIG. 34 shows the hybriddual toroid drive136 with a pair of associatedbearings272,274 operatively mounted on theslide plate138. Thebearings272,274 and theirtoroid abutting surfaces276,278 are spaced by a predetermined distance that allows the variable thickness camouter rim150 to be in substantially continuous contact while rotating. In this embodiment, therotation axis232 is substantially perpendicular to aplane280 between the bearingsurfaces276,278.
• The specially configuredbearing abutting surfaces282,284 of theouter rim150 advantageously provide an increased surface contact area with respective bearing surfaces276,278. This desirably decreases the pressure load between drivingtoroidal surfaces282,284 and the driven linearslide follower bearings272,274 and theirrespective surfaces276,278. Thebearings272,274 also provide for a low friction contact with the drivingtoroidal surfaces282,284 and advantageously improve wear-resistant properties.
• FIG. 35 shows a modified embodiment wherein thetoroid drive136 has anouter rim150athat substantially contacts the bearing surfaces276,278 mounted on theslide138 in a low surface area or point contact arrangement. In further embodiments, the camouter rim150 can directly contact theslide bearing surfaces164 and166, as needed or desired.
• FIG. 36 shows the operation of the toroidal transmission andpower converter system98 in a laboratory system set-up. Rotation of thetoroid drive136 is about the centralrotary axis232 is converted into linear reciprocating motion of theslide138 as generally indicated byarrows204. The slide is connected to thecutting blade106. Also shown are theslide bearings272 and274.
Irrigation Pump System
• A pulsatilewater pump system290 is incorporated into the disposablecutting blade assembly18 and is housed within thedistal cover72. The pulsatingwater pump290 supplies sterile water into a patient and in one embodiment is disposed after one use to insure no “patient to patient” bio-contamination. The pulsatile pump system of embodiments of the invention has utility in a number of fields and applications where fluid transport is desired. In one embodiment, a pulse of water is provided after each linear motion stroke.
• The integrated cutting bladewater pump system290 is advantageously driven by blade motion and insures that theblade106 will automatically be cooled and lubricated whenever thecutting blade106 is in reciprocating motion. In modified embodiments, an external pump system may be utilized, as needed or desired.
• Thewater pump system290 lubricates the reciprocating blade moving parts. Thewater pump system290 cools the reciprocating blade moving parts. Thewater pump system290 provides clear water for optical vision capability.
• The pulsatingwater pump system290 more effectively clears debris from the cutting blade surface for better cutting performance by providing pulsed jets of irrigation fluid. The pulsatilewater pump system290 is driven by reciprocating cutting blade motion pumps water whenever reciprocatingblade106 is driven. In modified embodiments, the system may have a manual override feature for pump operation.
• FIG. 37 shows the pulsatile dual directionwater pump system290 in accordance with an embodiment. Thepump system290 has astationary pump body292 that includes aninlet294, aflow chamber296 and anoutlet298. Theinlet294 is fed water from theumbilical cord16 or through another feedline. Theoutlet298 provides water to the bearingretainer118 within theblade shield108. The general direction of flow or the fluid path through thepump290 is generally indicated byarrows302.
• Theinlet294 has a one-way orcheck valve304 and theoutlet298 has a one-way orcheck valve306 to prevent undesired back-flow. Any one of a number of suitable valves may be used such as, but not limited to, pressure relief valves, ball-spring devices and the like.
• Thepump system290 includes a pair of spaced spring-biased or -loadedplungers308,312. In modified embodiments, other suitable resilient biasing or loading mechanisms may be efficaciously utilized, as needed or desired. Theplungers308,312 can move back and forth into thepump chamber296 to selectively occlude thepump chamber296 and/orfluid path302 to displace fluid and pulsatingly pump it to the desired site. Water is drawn in from theinlet294 through thevalve304 as theplungers308,312 move back towards their undepressed position.
• Theslide138 has alower surface314 with a pair of specially contoured and spaced cam surfaces316,318 that operatively couple theslide138 with thepump plungers308,312. During a forward linear stroke motion thedistal cam surface316 contacts or abuts thedistal plunger308 and depresses it to pump water out of theoutlet298. During a backward linear stroke motion theproximal cam surface318 contacts or abuts theproximal plunger312 and depresses it to pump water out of theoutlet298.
• Thus, the reciprocating linear stroke blade drive motion moves cam surfaces316,318 to alternatingly depress pump plungers and thereby pump water in a pulsing modality whenever the drivencutting blade106 is moved through a linear stroke by thetransmission system98. Desirably, thetransmission system98 provides the motion, force or energy to substantially simultaneously and synchronously drive thereciprocating blade106 and thepulsatile pump system290.
• In embodiments of the invention, thewater pump290 is integrated into the reciprocating blade mechanism. The pulsatile (pulsating with each linear stroke) water pump feature pulses a jet of water out through the cutting blade irrigation holes212 to keep the cuttingsurface114 clean for optimum cutting action. The pulse poweredpump290 is powered by the reciprocating action of thecutting blade106. Advantageously, this direct drive eliminates a separate pump drive source. This desirably saves parts and cost by eliminating a separate water pump.
• The disposablecutting tip assembly18 is sterile. It incorporates thewater pump290 which is also sterile. Thepump290 is very close or proximate to the site where the pressurized water is provided. Advantageously, this reduces pressure losses that would be incurred if the pump is at a distance from the point of use. It desirably also solves the problem of sterilizing a far away water pump.
• When thereciprocating blade device106 is cutting it should be provided lubrication and cooling and the cuttingsurface114 should desirably also remain clean and clear of tissue debris. Thewater pump290 pumps water when the cuttingsurface114 is activated as the same drive mechanism drives both. Thus, an operator need not remember to activate thepump290 since its operation is automatically actuated withcutting blade106. Desirably, this provides a safety feature to prevent damage, galling, a freeze up and also prevents cutting debris buildup and thermal glazing.
• Thepump system290 can be formed from a number of suitably durable materials. In one embodiment, thepump system290 is formed from a suitable plastic. The plastic material may comprise a suitable thermoplastic. In modified embodiments, other suitable plastics, metals, alloys, ceramics, combinations thereof, among others, may be efficaciously utilized, as needed or desired. Suitable surface coatings or finishes may be applied, as required or desired.
• Thepump system290 can be fabricated by using a number of manufacturing techniques. These include, but are not limited to, molding, machining, casting, forging, laser cutting and/or processing, laminating, adhesively fixing, welding, combinations thereof, among others, with efficacy, as needed or desired.
• FIG. 38 shows a pulsatile single directioneater pump system290ain accordance with another embodiment. Thepump system290aincludes aplunger320 connected to theslide138. During forward linear stroke motion theplunger320 occludes thepump cavity296 to displace water form theoutlet298 to the desired site. During backward linear stroke motion theplunger320 moves in an outward direction from thepump cavity296 and water is drawn into thecavity296 through theinlet294.
• Powered Handpiece
• FIG. 39 shows thepowered handpiece20 including the cover orhousing74, thevideo camera78, themotor assembly80 and adistal interface member322 for connecting to theinterface member102 andcoupling104 of thedistal tip assembly18. Theinterface member322 has anopening324 substantially aligned with theinterface opening158 which allow passage of the fiber optic probes124,126 for connection to thecamera78.
• Theproximal end70 of thedistal tip assembly18 and the handpiece's distal end orportion326 are configured and adapted to provide a quick and reliable connection or mating. This includes, but is not limited to, mechanical docking, electrical docking, optical docking and hydraulic docking.
• Thehousing74 andmotor assembly80 are steam sterilizable. The steam sterilization process involves the application of hot water and steam under pressure to kill germs followed by a partial drying process. The drying process is not always fully complete in that the instruments and parts processed, often come back partially wet. Usually there are small pockets of standing water trapped in small pools created by part shapes with water-titer pockets that end up facing upward due to there placement in the holding trays used to contain the parts and instruments to be steam sterilized.
• With the routine use of steam sterilization it is desirable that any optical or electronic parts that are used with the steam sterilized instruments be designed to provide solutions to residual water and the problems it can create with electromechanical and opto-mechanical components. As discussed further below, the motor housing also houses the video camera module, which in inserted into the freshly sterilized motor housing. The hermetically sealed video camera module is designed to specifically address the specialized problems of residual water in a freshly steam sterilized surgical instrument in a sterile surgical setup environment.
• Thehandpiece housing74 has amotor housing328 that receives themotor assembly80 and thevideo housing76 that receives thevideo camera78. Thevideo camera78 is contained in thevideo housing76 which provides a hermetically sealed housing. Thevideo housing76 desirably provides a water and gas sealed environmentally protective housing. Thevideo camera78 optically connects to theproximal end70 of thedistal tip assembly18 and interfaces with the imaging fiberoptics.
• Thecable16, thecover68 and the components of thehandpiece20 are sterilizable except for thevideo camera78 that is hard to sterilize. During assembly in a sterile field operating room, thenon-sterile video camera78 is inserted into a freshly sterilizedhandpiece housing74. A hermetic (gas and liquid) seal is created by O-ring seals or the like. The O-rings are part of the interface at the handpiece'sproximal end330 and thedistal end interface322. Advantageously, this hardware and procedure combined together enables a non-sterile delicate electronic video camera to be made bacteriologically safe inside the sterileouter housing74 of the sterilizedhandpiece20.
• Thehousing74 also contains anLED illuminator332 that connects to the illumination fiberoptics of thedistal tip assembly18. The LED (Light Emitting Diode)332 is also mounted into thevideo housing74 in a waterproof and gas-tight method to prevent intrusion and damage from water or water vapor accumulation. In one embodiment, a distalvideo imaging lens334 is recessed to help prevent accidental damage.
• Thecamera78 can be provided in amount336 with an outer shape that is designed to prevent the incorrect insertion into thehousing74. Themount336 has amale structure338 that is received within a matingfemale receptor opening340 within thehousing74. Themale structure338 provides themount336 with an asymmetrical cross sectional shape that is intended to create a visually obvious shape that can be readily inserted into its matingfemale receptor opening340 in the correct or desired orientation.
• In one embodiment, thecamera78 and themount336 comprise avideo module342 with thecamera78 housed in a waterproof and air-tight manner as discussed above in connection with thevideo housing74. The hermetically sealedvideo module342 can then be fitted within in thehousing74. TheLED332 can also be hermetically sealed within themodule342, for example, in anopening344.
• Thecamera78 can comprise any one of a number of suitable video or digital devices. In one embodiment, thevideo camera78 comprises a device as available from Toshiba. Advantageously, the integration of thevideo camera78 within thehandpiece20 greatly enhances the capability, compactness, utility and versatility of the system.
• As discussed above, the sterilizable poweredhandpiece20 contains a non-sterilenon-sterilizable video camera78 contained inside the sterile hand piece assembly. Advantageously, the sterilepowered handpiece20 hermetically seals thenon-sterile video camera78 in asterile housing74 or336, which permits safely using the sealed assembly in the sterile field and inside a patient's body.
• Thehandpiece20 can include one or more switches or buttons that allows the user to operably control the surgical file operation. Alternatively, or in addition, the controls can be provided on a separate platform and/or on thecontrol system14.
• Theprecision motor80 can comprise any one of a number of suitable rotary motion creating devices such as, but not limited to, gas turbines and electric motors and the like. In one embodiment, themotor80 comprises a gas or air turbine rotary motor that is fed pressurized air or gas through theumbilical cord16.
• In one embodiment, thegas turbine motor80 is provided air or gas at about 80 psi to run the device. In another embodiment, air or gas is provided at a pressure in the range from about 50 psi to about 100 psi, including all values and sub-ranges therebetween. In modified embodiments, the pressure can be lower or higher, as needed or desired.
• Themotor assembly80 at its distal end orportion342 includes arotatable power shaft344 connected to arotatable drive shaft346. The motordistal end342 docks with theproximal end70 of thedistal tip assembly18. Thepower shaft344 is generally received in the distal tip assembly holes162,160 and149.
• Themotor80 powers thereciprocating blade106. Themale drive shaft346 is substantially irrotationally received within the matching female receptor hole of thedrive shaft140 to provide rotary motion to thetransmission system98 that converts it into linear reciprocating motion.
• FIG. 40A shows a simpletriangular shaft346a that can engage thetriangular receptor hole254a.When thedistal tip assembly18 and thepowered handpiece20 are connected both the femaletriangular receptor hole254aand the motor's maletriangular drive shaft346acan rotate in tandem. The male and female features are free to mesh and align during the axial motion of connecting the disposablecutting tip assembly18 onto the reusablesterilizable motor handpiece20. This docking feature has a simplified rotary triangular shaped drive shaft, even though it drives a reciprocating (push-pull) motion-cutting blade.
• A triangular shaped male mating drive346ais desirable because it facilitates sterilization of the maletriangular shaft346a.The surfaces that are steam sterilized and reused are desirably simple surfaces that are easy to wash and clean. The surfaces should also enable reliable cleaning prior to sterilization. The triangularmale shaft346ahas three flat surfaces that are both easy to see and clean.
• In modified embodiments, other suitable male-female mating drive polygonal or non-polygonal interlocking configurations may be utilized with efficacy, as needed or desired. For example,FIG. 40B shows a generally square or rectangularmale shaft346bandFIG. 31C shows a generally hexagonalmale shaft346c.
• Surgical Methods
• The methods which are described and illustrated herein are not limited to the sequence of acts described, nor are they necessarily limited to the practice of all of the acts set forth. Other sequences of acts, or less than all of the acts, or simultaneous occurrence of the acts, may be utilized in practicing embodiments of the invention.
• The surgical instrument of embodiments of the invention enable the removal of obstructions in the tubular spaces (neuroforamen) between the vertebras of the neck and back. Desirably, this allows surgeons to navigate into the tiny (neuroforamen) canals between delicate nerve roots and remove small amounts of bony overgrowth (osteophytes) under direct vision.
• Embodiments of the invention allow a surgeon to safely navigate down into the neuroforamen canal next to the nerve roots and see and remove obstructions that cause nerve compression with direct vision. The surgeons can perform a new surgical procedure, a “micro foramentomy” through as small as about a ½ inch to about 1 inch incision. This advantageously represents a truly minimally invasive surgical procedure which would serve to benefit patients and surgeons.
• FIGS. 41 and 42 show a bone and/or tissue cutting procedure using thesurgical instrument12. The shieldedcutting blade106 is inserted into aneuroforamen348 between avertebra350, unwanted bone and/ortissue352 and anerve root354. Theshield108 protects thenerve root354 while theblade cutting surface114 removes the bone and/ortissue354 to relieve nerve compression by enlarging theneuroforamen348.
• Advantageously, embodiments of the invention provide a high level of cutting blade control and enable surgeons to reach into previously inaccessible areas to remove unwanted bone with precision, sensitivity and complete safety and confidence. The shielded cross sectional profile of embodiments of the cutting tip permit protection of delicate nerves during the neuroforamen enlargement process to relieve nerve compression.
• As seen inFIG. 42, the shieldedportion108 of the file is facing thedelicate nerve354 and theopposite cutting surface114 is facing the bone that is to be removed352 to enlarge the bony and cartilage structural opening. Advantageously, the surgical instrument of embodiments of the invention has a cuttingsurface114 that can travel around corners. A direct vision system allows surgeons to safely navigate into blind cavities of the patient's body and also assists visualization of the actual tissue cutting action and its results.
• In the embodiments of a sterile disposable (one time use) cuttingtip assembly18, the cuttingtip assembly18 is used typically, in one embodiment, for about three minutes in a two-hour surgical procedure. The tip of thedistal assembly18 can provide the surgeon with a picture of the area, and enable the doctor to see the cavity and its anatomical features.
• The view is magnified so the user sees a full screen image of the small tunnel, which is typically, in one embodiment, about one quarter of an inch in diameter. The enlarged view of the area allows surgeons to inspect and find the exact location and size of nerve irritation and compression, and determine where and how much bone and cartilage to remove to eliminate the nerve compression and relieve the pain.
• Orthopaedic File Embodiments, Components, and Procedures
• FIGS. 43-45 show different views of an orthopaedic shielded reciprocating surgical file instrument or apparatus12a.The surgical file instrument12agenerally comprises adistal tip assembly18adocked to and powered by ahandpiece20a.
• Thedistal blade assembly18agenerally comprises areciprocating blade106awith a cutting surface114aand a shield or guard108a.The cuttingsurface114 has an abrasive material orabrasives206a.
• Thedistal blade assembly18afurther includes ahandle356 above theblade106a.Thehandle356 is used by a surgeon to press against or down on the bone and/or tissue material to be removed. Thehandle356 is shaped to facilitate manipulation and has a suitable ergonomic shape or the like. Thehandle356 further includes anopening358 to facilitate operation.
• FIGS. 46-48 illustrate asurgical instrument400 in accordance with another embodiment. The illustratedsurgical instrument400 is a surgical file device that includes ahandle assembly403 and adistal tip assembly405. Thehandle assembly403 has apowered handpiece410 that is connected to amodular body assembly416. Themodular body assembly416 comprises ahousing418 that is connected to thedistal tip assembly405. Thedistal tip assembly405 includes adistal tip portion420 that has a somewhat L-shapeddistal tip422. Thesurgical file device400 also includes avisualization system430 that provides viewing of a target surgical area. When thedistal tip422 is used to perform a surgical procedure, thevisualization system430 provides viewing, preferably direct viewing, of the surgical site. The illustratedvisualization system430 includes anendoscope432 that can be connected to animaging capturing device434. Theendoscope432 can extend through themodular body assembly416 such that aviewing element470 is positioned to provide viewing of thedistal tip422.
• FIG. 47 illustrates thesurgical file device400 when unassembled. Thepowered handpiece410 is a powered device that can be used to operate thebody assembly416. The illustratedpowered handpiece410 is in the form of a standard motorized rotary handpiece that can be pneumatically powered, electricity powered, and/or mechanically powered. Other types of handpieces can also be used to drive thebody assembly416.
• Thehandpiece410 has adistal handpiece connector440 and aproximal handpiece connector442. Abody446 of thehandpiece410 extends between theconnectors440,442. Thedistal handpiece connector440 is configured to mate with ahandpiece docketing assembly446 of thebody assembly416. Preferably, thedistal handpiece connector440 is in the form of a quick connector that can be easily coupled to and removed from thehandpiece docketing assembly446. Various types of connectors can be utilized depending on the configuration of thebody assembly416 and thehandpiece410.
• To switch handpieces, the illustratedhandpiece410 can be decoupled from thehandpiece docketing assembly446. Another handpiece can then be coupled to thehandpiece docketing assembly446. The quick connection thus allows a user to quickly change between any number of handpieces. A single handpiece can be used with more than one body assembly.
• With reference again toFIGS. 46-48, theproximal handpiece connector442 is configured to be connected to anumbilical cord447 that can deliver power to thehandpiece410. Non-limiting exemplary umbilical cords can be pressurized air lines, electrical lines, and other types of lines that are used for effectively powering surgical devices. The illustratedumbilical cord447 ofFIG. 48 has anumbilical cord connector444 for coupling to theproximal handpiece connector442. To couple theline447 to thehandpiece410, theconnector444 can be inserted over theproximal handpiece connector442.
• As shown inFIG. 49, thedistal handpiece connector440 includes adrive shaft448 that can be coupled to a proximal end of adrive system480. The illustrateddrive shaft448 can be moved distally until it is coupled to thedrive system480. Thedrive shaft448 can be rotated by adrive motor450. Themotor450 is surrounded and protected by ahousing452. Thehousing452 provides a comfortable gripping surface for the user. Thehousing452 can advantageously provide a thermal barrier to limit heating of an outer gripping surface of thehandpiece410. As such, thehousing452 can form a surface that is maintained at a suitable temperature for gripping, even when themotor450 reaches elevated temperatures. In some cases, thehandpiece410 can drive a disposabledistal tip assembly405. After thedistal tip assembly405 is spent, thedistal tip assembly405 can be discarded and replaced with another distal tip assembly. If desired, the handpiece can be a standard handpiece. These types of powered handpieces are often found in hospital surgical rooms. Accordingly, themodular body416 can be used with standard power devices without the need of additional tools or power sources.
• With reference again toFIG. 46, themodular body assembly416 is configured to receive theendoscope432. Theendoscope432 extends through thehousing418 and thedistal tip portion420 so that theviewing element470 is positioned near thedistal tip422. When theendoscope432 is in the illustrated position, thebody assembly416 can securely hold theendoscope432. If desired, theendoscope432 can be retracted and pulled out of thebody assembly416 to perform maintenance on the endoscope, replace the endoscope, or for any other reason.
• To position theendoscope432, thehousing418 has a pair of guides476 (seeFIG. 47) configured to receive anillumination light port481 of theendoscope432. Theillumination light port481 of theendoscope432 can extend outwardly between theguides476 such that theguides476 inhibit rotation of theendoscope432 with respect to thehousing418. Theguides476 can advantageously maintain proper alignment of theendoscope432 during a surgical procedure, even if thesurgical file device400 is subjected to external forces or sudden acceleration, for example. The illustrated guides476 are protrusions that define a U-shaped channel that is sized to receive thelight port481. Other types of guides can also be used to position theendoscope432. One or more clamps, pins, ties, brackets, or other suitable structures can be used to position theendoscope432. Thus, various types of arrangements can be used to lock an endoscope tobody assembly416.
• With respect toFIG. 49, thebody assembly416 includes thedrive system480 for drivingly connecting thepowered handpiece410 to a cutting blade at thedistal tip422. Thedrive assembly480 is a mechanical transmission that converts rotary motion of thepowered handpiece410 to reciprocating, linear motion for driving the cutting blade.
• FIG. 50 illustrates thedrive system480 disposed in thehousing418. Thedrive system480 comprises atoroidal drive500 that is driven by themotor450 of thehandpiece410. Adrive shaft502 of thetoroidal drive500 can be permanently or temporarily coupled to thedrive shaft448 of thehandpiece410. Arim cam504 of thetoroidal drive500 is interposed between andcontacts follower bearings510 of aslide plate512. When thetoroidal drive500 rotates about its longitudinal axis, thecam504 pushes and pulls on thebearings510 because theslide plate512 is restrained so that it slides linearly along thehousing418.
• Thedrive system480 also includes adrive member516 extending through adrive member passageway530 formed in thehousing418. Thedrive member516 connects theslide plate512 to thedrive ribbon600. Alternatively, thedrive member516 can be directly connected to the blade.
• A sealingmember522 can surround thedrive member516 to inhibit fluid flow past thedrive member516 through thedrive member passageway530. Thedrive member516 and sealingmember522 cooperate to isolate fluid in thebody assembly416 in order to avoid damage to components of thesurgical file device400.
• Thedrive member516 can have any suitable configuration to engage the sealingmember522. Non-limitingexemplary drive members516 can have a polygonal, elliptical, circular, or any other suitable axial cross-section depending on the intended application. Thedrive member516 can be a tube, plate, rod, and the like. Thedrive member516 is preferably securely coupled to theslide plate512. As thetoroidal drive500 rotates, theslide plate512 and thedrive member516 are actuated together in a linear direction.
• The sealingmember522 can be disposed in a recess formed in thedrive member passageway530. The sealingmember522 is somewhat compressed against the outer surface of thedrive member516 and the wall of thepassageway530. In such a configuration, the sealingmember522 can effectively inhibit fluid flow along thedrive member passageway530 past the sealingmember522. Other sealing arrangements can also be employed to seal portions of thebody assembly416.
• With respect again toFIG. 49, thebody assembly416 can have afluid system550 for providing fluid irrigation and/or fluid removal at the surgical site. When thedistal tip422 is positioned at a surgical site, thefluid system550 can deliver irrigation fluid (preferably sterile irrigation fluid) to the surgical site to enhance tissue removal. Alternatively, or in addition, thefluid system550 can remove substances, such as irrigation fluid, tissue (including detached tissue, particulate, debris, contaminants) and the like, from the surgical site.
• Thebody assembly416 has aninlet connector560 and anoutlet connector562 that are configured to connect to aninput fluid line571 and anoutput fluid line573, respectively. SeeFIG. 48. Fluid delivered into theinlet connector560 can be circulated through thebody assembly416 and is eventually expelled out of thedistal tip422 at the surgical site.
• In some embodiments, material at the surgical site (e.g., tissue and the irrigation fluid) can be sucked into thedistal tip422 and is eventually drawn through thesurgical file device400 until it reaches theoutlet connector562. The fluid can then be delivered out of theoutlet connector562 and into theoutlet line573. Thus, fluid can flow continuously into and out of thesurgical file device400 to irrigate a surgical site and/or remove undesirable substances at the surgical site.
• The irrigation fluid can be delivered by any suitable means to theinlet connector560. To aid fluid flow through thefluid system550, one or more pressurization devices can be employed to pressurize the irrigation fluid. For example, pumps, such as a parastolic pump, can be connected to the fluid line. The pump can pressurize the irrigation fluid to enhance fluid flow through thefluid system550.
• Theinlet connector560 and theoutlet connector562 can have various configurations as are known in the art. Preferably, theconnectors560,562 are quick connectors configured to couple to standard fluid lines. In some embodiments, theconnectors560,562 have a different configuration from each other so that a clinician can visually distinguish between the connectors. This can help the clinician determine which line should be attached to a particular connector. Theinlet connector560 ofFIG. 48 can be specifically designed to receive theinlet fluid line571 but not theoutlet fluid line573. Similarly, theoutlet connector562 can be specifically designed to receive theoutlet fluid line573 but not theinlet fluid line571. Accordingly, theconnectors560,562 may reduce the likelihood that an improper line is connected to the corresponding connector. Alternatively, theconnectors560,562 can have similar or identical configurations, if desired.
• With reference toFIG. 50, anirrigation system551 includes aninlet connector passageway570 of that extends to avalve system574. Thevalve system574 of theirrigation system551 regulates fluid flow through thebody assembly416. Thevalve system574 is in the form of a check valve that permits one way flow therethrough. The illustratedvalve system574 comprises amovable valve member580 and a biasingmember582. Avalve member chamber584 houses themembers580,582. Themovable valve member580 bears against a narrowingportion569 of thevalve member chamber584. The biasingmember582 is interposed between thevalve member580 and an upper end of thevalve member chamber584. Fluid can flow through thevalve system574 by lifting thevalve member580 away from the surface of the narrowingportion569, but pressure in the opposite direction will force thevalve member580 against the narrowingportion569 inhibit fluid flow in the reverse direction.
• The illustrated biasingmember582 permits fluid flow through thevalve system574 when a relatively low pressure differential exists. For example, when the upstream pressure is equal to or greater than 3 psi greater than the downstream pressure, thevalve system574 can open. The pressure differential moves thevalve member580 thereby compressing the biasingmember582 to open thevalve system574. Once the pressure differential drops to less than3 psi, the biasingmember582 moves thevalve member580 to the closed position. The stiffness of the biasingmember582 can be chosen based on the desired actuation pressure for opening and closing of thevalve system574. Other types of check valves, gate valves, flow regulators, and the like can be used to control fluid flow through thedevice400.
• Thefluid system550 can also have apumping chamber590 that is in fluid communication with thevalve system574 and thedistal tip422 illustrated inFIG. 46. Thepumping chamber590 is configured to contain fluid that can be pressurized to a sufficiently high pressure such that the fluid flows through adelivery lumen614 that extends along the length of thedistal tip portion420. The pressurized fluid ultimately can be expelled out of thedistal tip422.
• To pressurize fluid in thepumping chamber590, thedrive member516 can be actuated between a first position and a second position. In some embodiments, including the illustrated embodiment ofFIG. 50, thedrive member516 reciprocates in a forward and backward motion.
• The pressure in thepumping chamber590 is increased or decreased as thedrive member516 is moved distally or proximally, respectively. When thedrive member516 is displaced proximally, the pressure in thepumping chamber590 can be sufficiently reduced so that fluid flows through thevalve system574 and into thepumping chamber590. When thedrive member516 moves distally through thepumping chamber590, the pressure within thechamber590 is increased. The increased pressure causes thevalve system574 to close. Additionally, the pressurized fluid flows from thepump chamber590 through aribbon passage602 and thedelivery lumen614.
• With reference toFIGS. 50 and 50A, thedelivery lumen614 of thedistal tip portion420 extends from theribbon passage602 to thedistal tip422. Fluid flowing distally through thedelivery lumen614 can proceed along thedistal tip portion420 until it is ultimately expelled out of thedistal tip422. One of ordinary skill in the art can select the size of thedelivery lumen614 to achieve a desired fluid flow through thedistal tip portion420.
• As shown inFIG. 51, thedistal tip422 outputs irrigation fluid, F, to irrigate a surgical site. In the illustrated embodiment, the irrigation fluid F flows out of ablade592 mounted to alower blade structure593. To remove the freshly cut tissue and expelled irrigation fluid, thefluid system550 can also comprise anoptional removal system594. Theremoval system594 can draw in the mixture of freshly cut tissue and irrigation fluid to improve visibility of the surgical site.
• Theremoval system594 includes an inlet -port595 positioned so that material at the surgical site can be drawn into thedistal tip422. The position and configuration of theinlet port595 can be chosen based on the flow dynamics of the irrigation fluid. The illustratedinlet port595 is position at the distal-most portion of thelower blade structure593 of thedistal tip422. Adistal face597 of thelower blade structure593 can define theinlet portion595. Irrigation fluid can flow distally along theblade592. Once the fluid reaches the end of thedistal tip422, the fluid flows around thedistal tip422 towards theinlet port595. As shown inFIG. 51, the mixture of solids (e.g., particulate, contaminates, tissue, etc.) and irrigation fluid can be pulled into theinlet port595 and then flows proximally along areturn lumen620 towards thehousing418.
• The illustratedinlet port595 is a single aperture. However, theinlet port595 can include a plurality of apertures for receiving material at the surgical site. The positions and the sizes of the apertures can be selected to achieve the desired flow dynamics for effective irrigation of the surgical site. In some embodiments, thedistal tip422 can have a plurality of inlet ports positioned along the lateral sides and/or the front surface of thedistal tip422.
• With reference toFIGS. 50 and 51, thereturn lumen620 provides fluid communication between theinlet port595 and the outlet connector562 (seeFIG. 49) of theremoval system594. In some embodiments, thereturn lumen620 extends through thedistal tip portion420, thehousing418, and thehandpiece410. Suction or aspiration can be provided by thefluid line573 attached to theoutlet connector562. Thus, theremoval system594 and theoutlet line573 can cooperate to remove material from the surgical site that may undesirably obstruct a physician's viewing. As such, the visual sight field can remain substantially free of debris for a clear line of sight for enhanced viewing of the cutting blade and the tissue removal process. Theremoval system594 can also remove contaminates, debris, detached tissue, and the like. Alternatively, or in addition, thesurgical file device400 can have one or more pumps for drawing fluid through thereturn lumen620.
• With reference again toFIG. 50, the reciprocatingdrive ribbon600 couples thedrive member516 to thecutting blade592. In some embodiments, the reciprocatingdrive ribbon600 can be a somewhat thin, flexible band that is sized to fit within aribbon passageway602. In some non-limiting embodiments, thedrive ribbon600 is constructed of metal (e.g., stainless steel) and has a thickness of about 0.004 to 0.008 inches. In such an embodiment, thedrive ribbon600 can bend easily through thecurved ribbon passageway602. Other materials can also be used to form thedrive ribbon600. Thedrive ribbon600 can preferably flex and assume a curved shape, even whendrive ribbon600 is reciprocated. As used herein, the term “reciprocate” is a broad term and includes, but is not limited to, the concept of moving an object alternatingly in substantially opposite directions. If thedrive ribbon600 is made of a stainless steel, the ribbon660 can be flexible with high deflection limits. In alternative embodiments, thedrive member516 can be connected to theblade592 by a flexible rod or other suitable structure. The rod can comprise a flexible material so that it can assume various curved configurations. The rod can be a single element or may comprise multiple elements. Alternatively, thedrive member516 can be directly coupled to the proximal end of thecutting blade592.
• Because thedrive ribbon600 ofFIG. 50 can assume a curved configuration, thetoroidal drive500 can be positioned away from the longitudinal axis of thedistal tip portion420. Thetoroidal drive500 can thus be spaced from theendoscope432 extending through thehousing418. Accordingly, thehousing418 can have a somewhat compact configuration.
• Thedistal tip portion420 ofFIGS. 50 and 50A has abody598 that has a workinglumen610 extending the entire length of abody598. Thedelivery lumen614 and thereturn lumen620 also extend axially through thebody598. The upper portion of theblade590 may or may not be disposed within thedelivery lumen614 or the workinglumen610. The illustratedworking lumen610 extends axially along thedistal tip portion420 to a distal tip portion opening614 ofFIG. 51. During a surgical procedure, irrigation fluid can flow through thebody598 via thedelivery lumen614.. The irrigation can flow out into the surgical site. Fluid and cut tissue can be sucked in thedistal tip422 and can flow proximally through the thereturn lumen620. As detailed above, the fluid can then flow through thehousing418 and through thepowered handpiece410 until it eventually flows out of thefluid outlet connector562 and into theoutlet line573.
• Thebody598 can be constructed of metal, polymers, plastics, combinations thereof, or any other suitable material having appropriate structural properties for the intended application of thedevice400. Additionally, thebody598 can have any number of lumens. The illustratedbody598 has four lumens, but the body can have any number of lumens nding on the application. The lumens of thebody598 can have polygonal (including rounded polygonal), elliptical, circular, or any other cross-section as desired.
• FIG. 47 illustrates areceptor port618 of thehousing418 that is configured to receive adistal end620 of theendoscope432. To assemble themodular body assembly416 and theendoscope432, thedistal end620 of theendoscope432 can be inserted into thereceptor port618. Theendoscope432 can then be advanced along theinstrument lumen610, until an enlargedproximal portion619 of theendoscope432 contacts aseat622 of thehousing418, as shown inFIG. 50. Theenlarged portion619 and theseat622 can have a similar shape. When theendoscope432 is assembled with thebody assembly416, theguides476 andseat622 cooperate to hold securely theendoscope432.
• Anelongated body640 of theendoscope432 can have such a length that theendoscope432 extends through thehousing418 and thedistal tip portion420. Thedistal end620 of theendoscope432 preferably extends out of the distal portion opening614 (seeFIG. 51). The illustratedelongated body640 is a cylindrical body sized to fit within the workinglumen610 of thedistal tip portion420.
• As shown inFIG. 48, theendoscope432 can be inserted into thereceptor618 in the direction indicated by thearrow483. Theendoscope432 can be inserted into thebody assembly418 until theenlarged portion619 of theendoscope432 rests against theseat622 of thehousing418.
• FIG. 52 illustrates thedistal tip422 of thesurgical file device400. Thedistal end620 of theendoscope432 extends out of thedistal portion opening614 and is near the cutting surfaces of thecutting blade592. The illustratedendoscope432 ofFIG. 53 is aligned to provide a field of vision for direct visualization of a surgical site. The line of sight of theendoscope432 can be generally aligned with the longitudinal axis of theblade592. If the endoscope is in such a position, the user can view thecutting blade592 cutting tissue during a surgical procedure. However, theendoscope432 can be at other orientations depending on the surgical procedure. For example, theendoscope432 can have a line of sight that is offset or angled from the centerline of thecutting blade592. In the illustrated embodiment, thedistal tip portion420 has alongitudinal axis453. Theendoscope432 provides viewing of adistal tip422 when thedistal tip422 is offset from thelongitudinal axis453.
• In the illustrated embodiment ofFIG. 53, thedistal end620 of theendoscope432 defines theviewing element470 in the form of optical prism. The configuration of the prism can be chosen based on the desired range of viewing. The illustratedviewing element470 is in a 70 degree prism (i.e., δ is about 70 degrees) that defines a field of vision having an angle α. The illustratedviewing element470 has a 50 degree field of vision, although theviewing element470 can have any desire field of vision. For example, field of vision can have an angle a that is about 40 degrees, 50 degrees, 60 degrees, or any other angle suitable for providing adequate visualization to an operator. Thisviewing element470 provides direct visualization during navigation of thesurgical file device400 and positioning of thedistal tip422. This enables an operator to navigate in areas of the body having sensitive nerve roots, blood vessels, or other delicate structures under direct vision.
• Various types of diagnostic tests can be performed to evaluate and determine an appropriate treatment for a patient. A patient may have a disorder (e.g., facet joint disorder) that adversely affects the patient. Thesurgical file device400 can be used to perform a procedure that may alleviate discomfort, improve spine functioning, or otherwise improve functioning or health of a patient.
• Thedistal tip portion420 extends away from thehousing418 and terminates at adistal tip422 that is curved away from the longitudinal axis of thedistal tip portion420. The illustrateddistal tip422 has a somewhat L-shape. However, thedistal tip422 can have other configurations depending on the intended use of thesurgical file device400. For example, thedistal tip422 can have a somewhat J-shaped configuration. Theblade592 is positioned above thelower blade structure543. Thelower blade structure543 supports theblade592 when theblade592 is actuated. The illustratedlower blade structure543 is wider then theblade592.
• FIG. 54 illustrates thecutting blade592 of thedistal tip422engaging tissue630 on a facet joint629. The upwardly facing cutting surface of thecutting blade592 can cut off tissue630 (e.g., boney overgrowth). In some instances, thetissue630 can be a bone spur or a portion of an enlarged region of the joint629. Thecutting blade592 can be actuated to remove (e.g., grind, cut, file, etc.) a desired amount oftissue630. The physician can view the surgical procedure using thevisualization instrument430 to ensure accuracy of the treatment. In the illustrated procedure, theviewing element470 of theendoscope432 is proximate to the surgical site for viewing thecutting blade592 and thetissue630.
• The illustrateddistal tip422 is interposed between the facet joint629 and anerve root631. Thedistal tip422 can be slid between the facet joint629 and thenerve root631 without injuring thesensitive nerve root631. The blunt,atraumatic tip422 has ashield641 that protects thenerve root631. Thus, thedistal tip422 can be configured to fit safely between the anterior portion of the facet joint629 and nerves (e.g.,nerve roots631 or ganglion) for safely removing a portion of the facet joint629. The curve and angle of thedistal tip portion420 can be chosen such that thedistal tip422 can be easily inserted between the facet joint629 and an adjacentvertebral body643. In some embodiments, thedistal tip422 is shaped to match the angle of a neural foramen canal. For example, if the neural foramen canal is angled at20 degrees sloping down from horizontal when a patient is positioned face down, thedistal dip422 can also have a 20 degree angle. As such, the configuration of thetip422 can be selected to match the patient's physiology. The surgical instrument described herein can be used in neuroforamina anywhere in the body, including the spine, skull, and other bones through which nerves extend.
• As tissue is removed from the facet joint629, theirrigation system551 andremoval system594 can be used for continuously (or intermittently) irrigating and cleaning the surgical site thereby avoiding debris buildup and improving viewing of the surgical site. Thedistal tip422 can be moved along the facet joint629 as theblade592 reciprocates to remove target tissue. Thedistal tip422 can also be used for general bone sculpturing, if desired.
• Thedistal tip422 can also have other configurations to treat other portions of a patient's body.FIG. 55 illustrates anotherdistal tip644 that is positioned to remove tissue from avertebral body643. Thedistal tip644 is generally similar to thedistal tip422, except as detailed below.
• Thedistal tip644 has a downwardly facingcutting blade690 and anopposing shield692. To removetissue642 from thevertebral body643, thedistal tip644 can be inserted between thenerve root631 and thevertebral body643. Theshield692 can contact and protect thenerve631. Thedistal tip644 can be utilized to remove tissue from the posterior portion of thevertebral body643 in the neural foramen area. To move thedistal tip644 to the illustrated position, thedistal tip644 can be slid over the dura mater and then between thenerve631 and the vertebral body. The dura mater is a tough fibrous membrane that envelopes the spinal nerves that can be navigated through to remove tissue from the spine. Thedistal tip644 can be delivered to the target site with or without using an access device, such as the introducer discussed above. Additionally, thedistal tip644 may or may not have an irrigation system and/or removal system.
• An access device can optionally be used for positioning a surgical instrument, such as thefile device400.FIG. 49 illustrates thedistal tip portion420 extending through anaccess device638 in accordance with one embodiment. In some embodiments, including the illustrated embodiment, theaccess device638 is an introducer. A standard tubular introducer for lumber spine surgery has an inner diameter of about 22 mm. If such an introducer is used, thedistal tip portion420 can have a spin diameter that is less than 22 mm. However, thedistal tip portion420 can have other spin diameters, if desired. The spin diameter can be selected based on the surgical procedure and/or the type and size of introducer utilized.
• After theintroducer638 is positioned in the patient, thedistal tip422 can be inserted through anupper end639 of theintroducer638 and then advanced through theintroducer638. Thedistal tip portion420 can be advanced distally until thedistal tip422 is exposed fromlower end651 theintroducer638 and is positioned at the target surgical site. Theintroducer638 provides a delivery path to the target surgical site. Non-limiting exemplary access devices can be a tube, sleeve, or other device capable of providing a delivery path for insertion of a surgical instrument to a target surgical site.
• In some embodiments, one or more of the components of thesurgical file device400 are disposable. As used herein, the term “disposable” when applied to a component, such as a body assembly (e.g., thebody assembly416, distal tip assembly, etc.) is a broad term and means, without limitation, that the component in question is used a finite number of times and then discarded. Some disposable components are used only once and then discarded. Other disposable components are used more than once and then discarded. In some embodiments, the body assembly of the surgical file device is a single-use component. Such body assemblies assures that sterile irrigation fluid is delivered to a surgical site, if the surgical file device has a fluid system. In alternative embodiments, the body assembly of thesurgical device400 is a multiuse component that may or may not be sterilized after each use.
• FIG. 56 illustrates adrive system700 of a surgical instrument for actuating a cutting blade. The surgical instrument699 can be similar to thesurgical instrument400, except as detailed below. InFIG. 56, many of the internal components of the instrument have been removed to more clearly illustrate thedrive system700.
• Thedrive system700 translates rotary motion to linear motion. Theillustrated drive system700 comprises adrive member702 that has adrive connector706, aslide plate connector708, and adrive member body710 therebetween.
• Thedrive connector706 is configured to engage a portion of a powered handpiece, such as thehandpiece410 ofFIG. 46. Thedrive connector706 can be coupled to a rotatable output shaft of a handpiece. If thehandpiece410 ofFIG. 46 powers thebody assembly416 ofFIG. 56, thedrive connector706 can be adapted to mate and lock with thereceptor shaft448 of thehandpiece410. Alternatively, thedrive connector706 can be adapted to mate with other output structures based on the design of the powered handpiece. Thedrive connector706 is preferably coupled to a structure that imparts rotary motion to thedrive member702.
• Thedrive member body710 extends between thedrive connector706 and theslide plate connector708. Thedrive member body710 can be a shaft, rod, tubular member, or other suitable member for imparting rotary motion. Thebody assembly416 can have brackets, a drive member passageway, or other structure for pivotally holding thedrive member710. As such, thebody assembly416 and drivemember body710 are arranged so that thedrive member702 is rotatable about its longitudinal axis.
• Theslide plate connector708 is connected to an axiallymovable slide plate716. As shown inFIGS. 56-59, theslide plate connector708 can have apin722 that extends through aslot726 of theslide plate716. Thepin722 extends outwardly from adistal face727 of theslide plate connector708. As thedrive member702 rotates, thepin722 travels along a somewhat circular path about thelongitudinal axis713 of thedrive member702. The traverse dimension of the travel path of thepin722 determines the axial travel stroke of theslide plate716. Thepin722 slides back and forth in theslot726 when thedrive member702 rotates about its longitudinal axis. Therotating pin722 also axially displaces theslide plate716 towards or away from the elongatedistal tip portion420 as indicated by thearrows732. Hence, theslide plate716 is reciprocated as thedrive member702 is rotated.
• Theslide plate716 ofFIGS. 56 and 59 has the elongatedslot726 that is sized to receive thepin722. The longitudinal axis of theslot726 is somewhat perpendicular to the direction of travel of theslide plate716. The length of theslot726 is preferably greater than the diameter of the travel path of thepin722. Theslide plate716 is connected to theupper end738 of the cutting blade. In such embodiments, theslide plate716 and cutting blade can be reciprocated together.
• With continued reference toFIG. 56, the instrument699 also includes a working lumen for receiving a visualization instrument. The illustrated instrument699 has a workinglumen721 configured to receive a visualization instrument, such as an endoscope, although other visualization instruments can be employed.
• FIGS. 60-64 illustrate another embodiment of a surgical instrument. In the illustrated embodiment, thesurgical instrument800 comprises a straight distal tip cutting blade, straight ribbon drive or tube drive, with suction and irrigation. This design can be powered by a standard specialized power handpiece. This illustrateddistal tip assembly802 is configured to be mated to an existing rotary motor poweredhandpiece816.
• Thedistal tip assembly802 can have a relatively simple design and can be mounted onto a standard powered surgical hand piece. These standard powered surgical hand pieces are often built to drive rotary cutting tools. Thedistal tip assembly802 converts the rotary handpiece into a reciprocating cutting instrument. Rotary instruments may often have a rotating cutter. Unfortunately, these rotating cutters skip sideways, especially when the rotating cutter touches hard to cut tissue, such as bone. Additionally, rotary cutting tools may not be suitable for forming a smooth or flat sculptured surface. By comparison, the illustratedreciprocating cutting instrument800 can avoid sideways skipping. Thedistal tip assembly802 cuts an inherently smoother and flatter surface with dramatically improved control, and therefore reduces fatigue of the surgeon's hands. Thus, thesurgical file system800 is easier to operate and can be safer for the patient than systems employing rotary cutting instruments.
• As shown inFIGS. 60 and 61A, thedistal tip assembly802 is coupled to adistal end812 of ahandle assembly816. A quickconnect docking mechanism822 connects thedistal tip assembly802 to the handpiece or handleassembly816. In some embodiments, thedistal tip assembly802 is removably coupled to thehandle assembly816. Threads of thedistal tip assembly802 can engage threads of thehandle assembly816. For example, themechanism822 can have internal threads that mate with external threads of thedistal tip assembly802. Alternatively, pins, screws, snap structures, or the like can be utilized to temporarily couple thedistal tip assembly802 to thehandle assembly816. If desired, thedistal tip assembly802 can also be permanently coupled to thehandle assembly816
• Thedistal tip assembly802 has adrive system826 and ahousing830 that surrounds thedrive system826. Aninlet connector836 ofFIG. 60 of a fluid system extends outwardly from thehousing830. The modifieddistal tip assembly802 ofFIGS. 61A and 61B does not have an inlet connector. Thedistal tip assembly802 tapers distally and has a substantially straightdistal tip840.
• In the illustrated embodiment, thedistal tip assembly802 is in the form of a removal, disposable tip. As such, thedistal tip assembly802 can be conveniently removed from thehandle assembly816 when desired. Accordingly, one or more distal tip assemblies can be used to perform a surgical procedure. The embodiment ofFIG. 61 is illustrated without an irrigation system. However, thedistal tip assembly802 can have an irrigation system and/or a removal system, as shown inFIGS. 62-64.
• With respect toFIGS. 62-63, acoupling assembly817 is configured to be coupled to a handle assembly. Thecoupling assembly817 is operatively connected to ashaft844 of thedrive system821. The illustratedcoupling assembly817 is rotatable about its longitudinal axis and one ormore ports831 in fluid communication with theshaft844. That is, thecoupling assembly817 is fixedly attached to theshaft844. In such an arrangement, thecoupling assembly817 and theshaft844 can rotate together. The coupling assembly design can be selected based on the handpiece.
• Theshaft844 can form part of thefluid system838. The illustratedshaft844 has ashaft passageway846 that permits transportation of waste fluids from thedistal tip assembly802 into thehandle assembly816. A shown inFIG. 62, theshaft844 can be a hollow or tubular shaft that is suitable for transporting fluids while also being capable of transmitting rotational forces. If thedistal tip assembly802 does not have thefluid system838, theshaft844 can be a solid shaft that extends between the drive motor of thehandle assembly816 and thedistal tip assembly802. Thus, various types of shafts can be used for operatively coupling thedistal tip assembly802 to thehandle assembly816. Of course, other types of coupling structures can also be utilized.
• Thedrive system821 includes theshaft844, atoroidal drive850, and aslide plate852 operatively connected to a cutting blade. Thedrive system821 preferably converts rotary motion into linear motion. Thetoroidal drive850 is rotatably mounted to aface plate862 and atoroidal holder864. In some embodiments, thetoroidal drive850 is supported by a pair of bearings.
• In the illustrated embodiment ofFIG. 62, thetoroidal drive850 and therotating shaft844 are supported by twobearings853,856, respectively. Theshaft passageway846 extends proximally from the bearing856 through theface plate862 and into thehandle assembly816. To seal the fluid from the toroidal drive, a sealing member867 (e.g., an O-ring) is positioned between thehousing810 and theshaft844. In such an embodiment, thedrive system821 can remain dry during operation to avoid contamination and damage of its components.
• Anouter rim857 of thetoroidal drive850 is positioned somewhat midway between theface plate862 and theholder864. The toroidouter rim857 warbles as thetoroidal drive850 rotates. Thetoroid rim857 drives a pair offollower bearings861 that are connected to theslide plate852. Rotation of thetoroidal drive850 causes liner movement of theslide plate852.
• Theslide plate852 can be guided in its linear travel by one or morelinear guides870 as shown inFIGS. 63 and 64. Theslide plate852 is preferably connected to ablade assembly880. Theslide plate852 drives the cuttingassembly880 as thetoroidal drive850 rotates. The cuttingassembly880 extends distally from theslide plate852 through thedistal tip assembly802. The cuttingassembly880 includes anelongated body882 and acutting blade884 at thedistal end886 of thebody882. The illustrated cutting assembly can be a multi-piece structure that has a movableupper cutting surface885 mounted toslidable plate887. Alternatively, the cutting assembly can be similar to blade assembly of the instrument illustrated inFIG. 69.
• Theelongated body882 has an elongatedbody passageway891 for transporting fluids. The illustratedelongated body882 is a tubular body that defines theelongated passageway891 extending between thepassageway846 and thecutting blade884. Fluid (including irrigation fluid, tissue, etc.) can flow proximally from the distal end ofdistal tip assembly802 through theelongated body882 via thepassageway891. The fluid then proceeds along thepassageway891 and into thepassageway846.
• Because theelongated body882 is subjected to axial loads during operation, its axial cross section can be chosen to avoid buckling or other failure modes. Theelongated body882 can be comprised of metal, such as steel (including stainless steel), titanium, or other suitable material. For example, theelongated body882 can be comprised of a high strength plastic.
• Theelongated body passageway891 of thehousing810 surrounds at least a portion of theelongated body882, and can limit flexing of theelongated body882. Hence, theelongated body passageway891 can inhibit buckling of theelongated body882.
• With reference again toFIG. 62, thefluid system838 has aninlet connector836 in communication with adelivery passageway910. Thedelivery passageway910 extends through thehousing810. A tapered or narrowing portion of thehousing810 defines theelongated passageway891 that cooperates with the outer surface of theelongated body882 of theblade assembly880 to form adistal portion908 of thedelivery passageway910.
• Irrigation fluid922 can be introduced through theinlet connector836 into thehousing810. The fluid proceeds through thedelivery passageway910 until it reaches thedistal portion908. The fluid then flows through thedistal portion908 of thedelivery passageway910. In some embodiments, the irrigation fluid acts as a lubricant to the cutting blade guides and also cleanses thecutting blade884 by exhausting out cutting holes920.
• The irrigation fluid can clean the surgical site. As shown inFIG. 63A the cleansing fluid and the freshly cut bone andtissue debris926 are hydrodynamically drawn along aflow path927 away from the cutting surface and into thelower blade structure921. In particular, the tissue and fluid are drawn into theinlet port928. The mixture then flows proximally through theelongated body passageway891. After the mixture exits theelongated body passageway891, it flows through thedrive system821, and is ultimately removed from thedistal tip assembly802.
• FIGS. 65-67 illustrate anotherdistal tip assembly950 in accordance with another embodiment. Thedistal tip assembly950 has adistal tip body951 and ahandle960 connected to thedistal tip body951. Thehandle960 is used to help a user control the movement of thedistal tip assembly950. Additionally, thehandle960 can be used for pressing anactuatable cutting blade964 against tissue.
• Thecutting blade964 and thehandle960 are on opposing sides of adistal end970 of thedistal tip assembly950. Thecutting blade964 protrudes out of anaperture974. The illustratedcutting blade964 has a somewhatconcave cutting surface970 as shown inFIG. 65. In some embodiments, the cuttingsurface970 is concave along the length of thecutting blade964. However, the cuttingsurface970 can have other shapes, if needed or desired. For example, thecutting blade964 can have a generally flat cutting surface for preparing a flat surface. Alternatively, thecutting blade964 can have aconvex cutting surface970.
• As shown inFIG. 67, theportion966 of thecutting blade964 extending out of theaperture974 has a height, H, of about 1 mm, 2 mm, 3 mm, 5 mm, and ranges encompassing such distances. In some non-limiting embodiments, theportion966 has a height H of more than about 5 mm. In some non-limiting embodiments, theportion966 has a height H of more than about 8 mm, 10 mm, and 20 mm. Theportion966 can have other heights also. In other embodiments, thecutting blade964 is generally flush with theaperture974. Thecutting blade964 can also be similar to the cutting blades described above.
• Thehandle960 is designed to be comfortably gripped between a user's thumb and index finger while the user's other hand holds an handle assembly to which the distal tip assembly is attached. The operator can use thehandle960 to provide a mechanical advantage in order to remove tissue at a desired rate. As thecutting blade964 cuts tissue, for example, thehandle960 can be used to press thecutting blade964 against the tissue. As such, the applied pressure and rate of tissue cutting can be accurately controlled. Thus, thehandle960 can be used for accurately positioning thecutting blade964 and/or controlling the rate of cutting.
• The illustratedhandle960 has depressions to enhance traction. The illustratedhandle960 hasdepressions963 on either side for receiving a finger or thumb of a user. Surface texturing, protrusions, or other structures can be used to help a user grip thehandle960. The illustratedhandle960 extends longitudinally along thedistal tip assembly950. However, thehandle960 can be at other orientations, if desired.
• The illustrateddistal tip assembly950 has asingle handle960. Other distal tip assemblies can have a plurality of handles. The configurations and positions of the handles can be selected based on the intended use of the surgical file device. In alternative embodiments, thestructure960 can be a guide that assists in positioning of thecutting blade964. Theguide960 can be positioned against tissue to help align thedistal tip950.
• FIG. 68 illustrated another distal tip assembly. The illustrateddistal tip assembly990 has a cutting blade992 that is somewhat recessed. Thedistal tip assembly990 may or may not have a handle depending on its intended use. The illustrateddistal tip assembly990 does not have a handle and has a low profile configuration.
• Advantageously, a single handpiece or handle assembly can be used with more than one distal tip assembly. During a single surgical procedure, the surgeon can use a plurality of distal tip assemblies to perform specific procedures. Thus, various portions of a patient's body can be treated without the need of several handpieces.
• FIG. 69 shows another embodiment of a surgical instrument. Thesurgical instrument1400 can be generally similar to the embodiments described above, except as detailed below. Generally, thesurgical instrument1400 can be used to remove tissue, such as unwanted bony overgrowth of the spine. Bony overgrowths can affect the neural foramen and can cause nerve root compression. The illustratedinstrument1400 is well suited for treating this type of nerve compression, although the instrument can be used to treat other conditions.
• Thedistal tip assembly1402 extends from ahandle assembly1403 and has along axis1401. Generally, thedistal tip assembly1402 comprises adistal tip portion1404 that includes a cutting implement or filing blade1412 (e.g., the blade of the blade assembly shown inFIG. 48).
• Thedistal tip portion1404 preferably comprises theblade1412 that overlays at least a portion of alower blade structure1420. Theblade1412 is preferably slidably coupled with thelower blade structure1420. The illustrateddistal tip portion1404 preferably forms an atraumatic tip. In some embodiments, the atraumatic tip is configured to engage a patient's body without causing traumatic injury. Such atraumatic tip can be a generally blunt tip, although the atraumatic tip can have any suitable design for minimizing trauma to a patient. The shape and configuration of the atraumaticdistal tip portion1404 can be chosen based on the application of thesurgical file instrument1400. In some embodiments, however, the distal tip portion may not comprise an atraumatic tip. For example, the distal tip portion may form a cutting edge for severing tissue. Thus, both sides of thedistal tip portion1404 can be used to perform a procedure on a patient.
• Ashield1408 can be formed by a lower portion of thelower blade structure1420. Theblade1412 can be positioned on one side of thedistal tip portion1404 and theshield1408 can be positioned on the opposing side of thedistal tip portion1404. Theblade1412 can be movably mounted to thelower blade structure1420 to provide cutting action. The exposed portion of theblade1412 is unrestrained by thelower blade structure1420. Irrigation of a surgical site can be provided via thedistal tip portion1404, as detailed below. Additionally, thedistal tip portion1404 can also have one or more inlet ports for tissue removal, although not illustrated.
• FIGS. 70-71 are elevation views of theinstrument1400 that has theblade1412 having a similar shape to thelower blade structures1420. Thelower blade structure1420 can have an average width that is similar to the average width of theblade1412. Anouter periphery1493 of theblade1412 can have a similar shape as aperiphery1405 of thelower blade structure1420. Thus, the overall shapes of theblade1412 andlower blade structure1420 can be similar to one another, as viewed from above.
• FIG. 72A is a cross-sectional view of theinstrument1400 taken along theline72A-72A ofFIG. 71. A lower surface1415 of theblade1412 can mate with anupper face1416 of thelower blade structure1420. Theblade1412 preferably extends longitudinally along theupper face1416.
• Theblade1412 can extend laterally across a substantial portion of thedistal tip portion1404. In some embodiments, the average width, Wb, of theblade1412 is at least 50%, 60%, 70%, 80%, 90%, or 95% of the average width, Wdt, of theshield1408,lower blade structure1420, and/orupper face1416. In the illustrated embodiments, theblade1412 has a width that is substantially similar to the width of thelower blade structure1420. Thelower blade structure1420 has the upper face1416 (seeFIGS. 73 and 74) that mates with theblade1412. In non-limiting embodiments, the width of theblade1412 is equal to or less than the width of theupper face1416. In some embodiments, the width of theblade1412 is at least about 95%, 90%, 85%, 85%, and ranges encompassing such percentages of the width of theupper face1416. In one exemplary non-limiting embodiment, the width of theblade1412 is at least about 95% of the width of theupper face1416. In another exemplary non-limiting embodiment, the width of theblade1412 is at least about 80% of the width of theupper face1416.
• Theblade1412 can have a shape that is generally similar to the shape of theupper face1416 of thelower blade structure1420. In the illustrated embodiment, theblade1412 and theupper face1416 of thelower blade structure1420 have a curved shape. However, theblade1412 can have other suitable shapes for cutting tissue. For example, theblade1412 can have a substantially arcuate, U-shaped, V-shaped, curved, linear, polygonal, combinations thereof, or any other suitable cross-sectional profile. Although not illustrated, theblade1412 can have a generally U-shaped cross-sectional profile and can extend vertically along both sides of thelower blade structure1420.
• When theblade1412 is utilized to treat tissue, thelower blade structure1420 may not limit cutting of theblade1412. That is, thelower blade structure1420 preferably does not extend laterally from theblade1412 to limit appreciably the vertical movement of theblade1412 into tissue. Of course, thelower blade structure1420 can extend slightly from theblade1412 without appreciably limiting the vertical cutting ability of theblade1412. Additionally, if thelower blade structure1420 extends laterally from theblade1412, theblade1412 can be moved horizontally (e.g., theblade1412 can be slid across tissue) for effective cutting action of thesurgical file instrument1400.
• FIGS. 73 and 74 illustrated thedistal tip assembly1402 with theblade1412 removed. Thelower blade structure1420 has along axis1401 and theupper face1416 extending between a firstlateral side1417 and an opposing second lateral side1419 (seeFIG. 72). Thedevice1400 has anirrigation system1417 having a fluiddelivery channel system1423 of thelower blade structure1420. Thedelivery channel system1423 extends longitudinally along theupper face1416.
• Thedelivery channel system1423 can cooperate with theblade1412 to expel irrigation fluid. Thedelivery channel system1423 includes anelongate delivery channel1424 and a plurality ofside delivery channels1422. Theelongate delivery channel1424 can be in communication with an irrigation fluid source via aninlet connector1480 of an adapter1652 (seeFIG. 71). Irrigation fluid can flow through thehandle assembly1403, thedelivery channel system1423, and ultimately out of thedistal tip portion1404.
• With respect toFIG. 74, theelongate delivery channel1424 can be sloped in the distal direction. In the illustrated embodiment, abottom surface1440 of theelongate delivery channel1424 is sloped towards theupper surface1416 in the distal direction. Theelongate delivery channel1424 can have a generally uniform or varying width along its length. The illustratedelongate delivery channel1424 has a generally constant width and has a generallyflat bottom surface1440, although thebottom surface1440 can have other configurations. Although not illustrated, theelongate delivery channel1424 can have a generally uniform height and can have any suitable cross-section for delivering fluid to thechannels1422. For example, theelongate delivery channel1424 can have a generally U-shaped, V-shaped, semi-circular, or curved axial cross-section.
• Thechannels1422 are spaced along a portion of thelower blade structure1420 and are in fluid communication with theelongate delivery channel1424. Theelongate delivery channel1424 is interposed between two rows ofchannels1422. Any suitable number ofchannels1422 can be positioned along thedistal tip portion1404. In the illustrated embodiment, eightchannels1422 are positioned on either side of theelongate delivery channel1424. Eachchannel1422 can have a generally semi-circular shape, polygonal shape (including rounded polygonal), or other shape suitable for delivering fluid out of thedistal tip portion1404. Thechannels1422 can be depressions formed in thelower blade structure1420. The number, sizes, and configurations of thechannels1422 can be selected to achieve the desired fluid flow out of thedistal tip portion1404. When theblade1412 mates with theupper surface1416, at least one of thechannels1422 can be covered by theblade1412. Theside delivery channels1422 can be formed by any suitable process, such as by a molding process (e.g., an injection molding process), cutting or machining process, or other suitable manufacturing process.
• FIG. 75 illustrates theblade assembly1413 having theblade1412 connected to anelongated body1460. Theblade1412 can comprise a cutting zone or cuttingsurface1432 configured to remove tissue as theblade1412 is actuated. In some embodiments, thecutting zone1432 comprises a plurality of cutting members, cutting teeth, sharp edges, and combinations thereof. Theblade1412 can have afirst blade edge1428 and asecond blade edge1430. The illustrated thefirst blade edge1428 and thesecond blade edge1430 are free edges that are not restrained by thelower blade structure1420. Thecutting zone1432 can be positioned between the blade edges1428,1430. Theblade1412 can be perforated for providing fluid flow therethrough. The illustratedcutting zone1432 comprises an array ofthroughholes1434. In some embodiments, at least one throughhole1434 is positioned near thefirst blade edge1428 and at least one throughhole1434 is positioned near thesecond blade edge1430. Thethroughholes1434 can be positioned near the sides of thecutting zone1432. Any number ofthroughholes1434 can be positioned along thecutting zone1432. Thecutting zone1432 can have a transverse width that is similar to, less than, or greater than a transverse width of theblade1412.
• In some embodiments, a plurality ofthroughholes1434 is positioned near thefirst blade edge1428 and a plurality ofthroughholes1434 is positioned near thesecond blade edge1430. In some embodiments, at least one throughhole1434 is positioned near the firstlateral side1417 and at least one throughhole1434 is positioned near the secondlateral side1419 of thelower blade structure1420. For example, in the embodiment ofFIG. 72A, the plurality of throughholes (e.g., cutting elements having a throughhole) is positioned near the firstlateral side1417 and a plurality of throughholes is positioned near the secondlateral side1419 of thelower blade structure1420. Thethroughholes1434 can be evenly or unevenly spaced along thecutting zone1432.
• With respect toFIG. 76, theblade assembly1413 can be actuated linearly by theelongated body1460 in the form of a drive member. Thedrive member1460 can be temporarily or permanently coupled to theblade1412. Theblade1412 can be used for a single procedure, or a plurality of procedures. In some embodiments, theblade assembly1413 is disposable and can be easily replaced with a new blade assembly after use. Alternatively, theblade assembly1413 can be a non-disposable component configured for one or more procedures. Any suitable attachment means, such as welding, mechanical fasteners, adhesives, or the like can be used to attach theblade1412 to thedrive member1460.
• In some embodiments, thedrive member1460 is operatively coupled to theblade1412 by a plurality of welds. The welds can have significant structure integrity and reliability. Theblade assembly1413 can comprise one or more of the following: metals (e.g., titanium, aluminum, steel and its alloys, such as stainless steel), plastics, polymers, ceramics, composites, and combinations thereof. Alternatively, theblade assembly1413 can have a one-piece construction. For example, theblade assembly1413 can be monolithically formed through a machining or molding process. Thus, theblade assembly1413 can have a one-piece or multi-piece construction.
• Theblade1412 is preferably movable between a distal position (FIGS. 77-78) and a proximal position (FIG. 79). Theblade1412 can be rapidly reciprocated between the distal position and the proximal position to remove tissue. In non-limiting embodiments, theblade1412 can be actuated 1,000 times/min., 2,000 times/min., 3,000 times/min., or 4,000 times/min. Theblade1412 can also be actuated at other rates. As theblade1412 slides along thelower blade structure1420, at least some of thethroughholes1434 of theblade1412 can be matched and unmatched with thechannels1422 to provide pulse irrigation. In some embodiments, a substantial number or all of thethroughholes1434 can cooperate with theelongate delivery channel1424 to provide pulse irrigation. The illustratedblade1412 and thelower blade structure1420 can cooperate to provide pulsatile flow even if the fluid is delivered to the distal tip at a constant or varying pressure.
• Any number of thethroughholes1434 can be positioned over theelongate delivery channel1424. As shown inFIG. 77, a series ofthroughholes1434 is adjacent theelongate delivery channel1424. Thus, some of thethroughholes1434 can be periodically aligned with thechannels1422 while at least some of thethroughholes1434 can be disposed over theelongate delivery channel1424. As such, some of thethroughholes1434 can provide pulse irrigation whileother throughholes1434 can provided somewhat continuous irrigation.
• In the illustrated embodiment ofFIG. 77, a center row ofthroughholes1434 is constantly fed irrigation fluid. The fluid can be provided at a generally constant or varying pressure, although the irrigation fluid can be provided at any pressure depending on the application. In some embodiments, the center row ofthroughholes1434 is fed irrigation fluid at varying pressures, preferably delivered in synchronization with the reciprocating rate of theblade1412. However, the irrigation fluid can be delivered in other relationships with the movement of theblade1412. The pressurized irrigation fluid can be delivered at varying rates to create an enhanced cleaning action to keep thecutting zone1432 clean and to remove tissue debris.
• The centrally disposed throughholes1434 can remove a substantial portion or most of the debris material and therefore may need constant fluid flushing. The flushing can be accomplished by variations in the pressure and flow rate of the irrigation fluid. The laterally offset throughholes1434 may remove less material during operation and can also benefit from variations in irrigation flow. In some embodiments, the nearly on and nearly off flow of the irrigation fluid effectively cleans the laterally offset throughholes1434. The variations in irrigation fluid temperature, flow rates, and pressure can be chosen to clean effectively tissue debris from theblade1412.
• The irrigation fluid can also be used to control the temperature of at least a portion of thedistal tip portion1404. For example, the frictional interaction between theblade1412 and thelower blade structure1420 can cause localized heating at the interface of theblade1412 and theupper surface1416. During operation, the irrigation fluid can be at a relatively low temperature and used to absorb heat generated by the frictional interaction. Accordingly, heat can be transferred to the irrigation fluid which then carries the heat away from thedistal tip portion1404 to cool the components of thedistal tip portion1404. In some cases, the irrigation fluid can be a chilled fluid to ensure that thedistal tip portion1404 is maintained below a target temperature. The irrigation fluid can be heated/cooled as desired.
• Irrigation fluid can function as a lubricant for the interface between the movingblade1412 and the stationarylower blade structure1420. The irrigation fluid can thus be used to clean theblade1412 and transport the cut tissue away while also lubricating thedistal tip portion1404. The lubricant irrigation fluid can minimize wear of one or more components of thesurgical file instrument1400.
• FIG. 78 illustrates theblade1412 in a distal position. When theblade1412 occupies the distal position, thedistal end1444 of theblade1412 is preferably proximate to adistal end1446 of thelower blade structure1420. Theblade1412 can be actuated proximally along thelower blade structure1420 to a proximal position shown inFIG. 79. When theblade1412 occupies the proximal position, thedistal end1444 is preferably distanced from thedistal end1446 such that at least a portion of thedelivery channel system1423 is exposed. In some embodiments, theblade1412 is moved laterally and/or longitudinally between two or more positions, if needed or desired.
• With respect toFIG. 79, when theblade1412 occupies a proximal position, theblade1412 and thelower blade structure1420 cooperate to define awindow1450. A fluid can be expelled through thewindow1450. The irrigation fluid delivered from thewindow1450 can be used to dislodge and flush tissue debris from thedistal tip portion1404, as well as for irrigating the surgical site. As theblade1412 moves in the distal direction, thewindow1450 is reduced in size. In some embodiments, when theblade1412 reaches its distal position (FIGS. 77 and 78), theblade1412 completely covers theelongate delivery channel1424 thereby completely closing thewindow1450. In the illustrated embodiment, theblade1412 and thelower blade structure1420 are configured to open and close thewindow1450 repeatedly for a somewhat on and off fluid flow. The pulsing fluid flow from thewindow1450 can aid in breaking up of clots and tissue debris. However, in other embodiments, theblade1412 and thelower blade structure1420 can be configured to provide continuous fluid flow out of thewindow1450. For example, thedistal end1444 of theblade1412 can be positioned at some point above thedelivery channel system1423 when theblade1412 occupies its distal-most position and its proximal-most position. In such an embodiment, fluid can be continuously delivered during reciprocation of theblade1412.
• The cyclic nature of the pertubated irrigation fluid can enhance cleaning and debris removal. The frequency and magnitude of the pulsed irrigation fluid flow can be selected to achieve the desired cleaning and debris removal effect. In some embodiments, the fluid perturbations can hold the tissue debris (e.g., bone particles, cartilage, and other debris material) in suspension. The suspension can be easily removed from the surgical site. For example, the suspension can be sucked out of the surgical area by a surgical suction wand, suction tube, or other tissue or removal device. Alternatively, or in addition, thedevice1400 can have a removal system for waste fluid removal. In some embodiments, for example, thedevice1400 can have a removal system similar to the removal system illustrated inFIG. 51.
• FIG. 80 illustrates theblade assembly1413 connected to internal components of thehandle assembly1403. Thedrive member1460 extends from thehandle assembly1403. As shown inFIG. 77, thedrive member1460 can be a generally tubular member that defines at least onelumen1476. As such, thedrive member1460 can have a reduced weight to therefore reduce the overall weight of thesurgical file instrument1400. Thedrive member1460 can have any suitable cross-section.Exemplary drive members1460 can have a generally circular cross-section, elliptical cross-section, polygonal (including rounded polygonal) cross-section, although thedrive members1460 can have other cross-sections depending on the application. The size and configuration of thedrive member1460 can be selected to minimize or avoid buckling, deflection, bending, and/or fatigue failure.
• In some embodiments, thelumen1476 can be in communication with thedistal tip portion1404. Thelumen1476 can be used to transport water to and/or from thedistal tip portion1404. Alternatively, thelumen1476 can be used to provide suction to draw in material (e.g., debris and suspension) from the surgical area through thedistal tip portion1404. Any fluid (e.g., lubricants, medicants, irrigation fluid, or combinations thereof) or material can be passed through thelumen1476 depending on the application.
• With respect toFIG. 81, to deliver fluid F (e.g., irrigation fluid) through thedistal tip portion1404, fluid can be delivered to theinlet port1480 of afluid delivery system1482. Thefluid delivery system1482 also comprises anadapter1652 and afluid supply tube1488 that connects theinlet port1480 to thedrive member1460. The irrigation fluid can pass through theinlet port1480 and theadapter1652. The irrigation fluid then flows through thesupply tube1488 and eventually through thedistal tip portion1404.
• The fluid F can flow distally along thesupply tube1488 and eventually to ajunction1490. The fluid F can then flow distally between adelivery tube1492 and thedrive member1460. Thedrive member1460 extends through the length of thedelivery tube1492. In some embodiments, thedrive member1460 and thedelivery tube1492 are generally concentric and define a fluid channel. The fluid channel can be defined by the outer surface of thedrive member1460 and the inner surface of thedelivery tube1492. The fluid F can flow distally through the fluid channel.
• Thesupply tube1488 can be made of a flexible material, such as silicon, rubber, or other suitable flexible material. However, thesupply tube1488 can also be made of generally rigid materials, such as metals or hard plastics. In the illustrated embodiment, thesupply tube1488 is connected to acoupler1502. Adistal end1504 of thesupply tube1488 is received by afemale receptor hole1506 of theconnector1502. Preferably, a water-tight seal is accomplished by coating thesupply tube1488 with a sealant (e.g., silicon rubber sealant, gels, and the like) and inserting thedistal end1504 into thefemale receptor hole1506. Additionally, one or more sealing members (e.g., annular sealing members) can be used to further seal in irrigation fluid. It is contemplated that other arrangements can be employed to connect thesupply tube1488 to thejunction1490.
• In operation, as shown inFIG. 82, the fluid F flows through thejunction1490 and through a flow chamber defined by thedrive member1460 and thedelivery tube1492. The fluid F flows distally along the fluid chamber until it reaches thedistal tip portion1404 and is eventually expelled out of thesurgical file instrument1400. In some embodiments, however, the fluid F can be delivered through a lumen within thedrive member1460. For example, the fluid F can be delivered through thelumen1476 of thedrive member1460 illustrated inFIG. 77. Thedrive member1460 can be disposed in theelongated channel1424.
• With reference again toFIGS. 81 and 82, theconnector assembly1510 can hold thedistal end1504 of thetube1488 and both thedelivery tube1492 and thedrive member1460. Theconnector assembly1510 surrounds both thedelivery tube1492 and thedrive member1460. In some embodiments, thedrive member1460 extends all the way through theconnector assembly1510. Thedistal end1504 of thetube1488 is positioned within theconnector assembly1510.
• Theconnector assembly1510 can include aconnector housing1512 that can define aconnector chamber1514. Thedelivery tube1492 and thedrive member1460 can extend centrally through thechamber1514. In the illustrated embodiment, thechamber1514 is tapered in the proximal direction. However, theconnector chamber1514 can have any other suitable shape and configuration depending on the application.
• As shown inFIG. 81, theconnector housing1512 is configured to receive a distal tip structureproximal end1520 of thedistal tip1522. The distal tip structureproximal end1520 is configured to fit within theconnector chamber1514. As such, theconnector chamber1514 and the distal tip structureproximal end1520 can have a similar shape so that the distal tip structureproximal end1520 is tightly held by theconnector housing1512. The illustrated distal tip structureproximal end1520 has a generally frusto-conical shape, although the distal tip can have other configurations.
• Theconnector system1510 can comprise asealing system1511 used to seal the fluid within thesurgical file instrument1400. Thesealing system1511 can comprise a plurality of sealing members that are strategically positioned at various points throughout thesurgical file system1400 to inhibit or prevent fluid from leaking. In the illustrated embodiment, thesealing system1511 comprises a first O-ring1530 that is positioned between the distal tip structureproximal end1520 and theconnector housing1512. The sealingmember1530 surrounds thetube1492 and substantially prevents fluid flow from escaping between thetube1492 and theend1520 and theconnector housing1512.
• Asecond sealing member1532 can be positioned proximal of thejunction1490. The illustratedsealing member1532 surrounds thedrive member1460 and prevents fluid flow proximally past the sealingmember1532. The sealingmembers1530,1532 can be any suitable sealing members for containing the fluid F. For example, the sealing members can comprise one or more O-rings, gaskets, sealing gels, or other suitable sealing structures and can comprise plastic, polymers, rubber, and the like.
• Theconnector housing1512 can comprise one or more ribs extending along its side. In the illustrated embodiment ofFIG. 80, theconnector housing1512 comprises a pair of diametrically opposed longitudinally extendingribs1533a,1533b.Thelongitudinal ribs1533a,1533bcan lock theconnector assembly1510 into position relative to thedistal tip1522. Theribs1533a,1533bcan be spaced at any location along the periphery of thehousing1512. Any number of longitudinally extending ribs can be used to orient theconnector assembly1510 with thedistal tip1522. Exemplary ribs can have generally U-shaped, V-shaped, semi-circular, polygonal, or any other shaped cross-sections.
• Theconnector housing1512 can comprise acylindrical collar1551 that engages thetip1522. Thecylindrical collar1551 can be positioned somewhat proximally along theconnector housing1512. Thecylindrical collar1551 can engage sealing members to absorb excessive linear forces, which may be due to reciprocation of theblade assembly1413.
• With reference again toFIG. 81, thesurgical file instrument1400 can comprise adrive assembly1540. Thedrive assembly1540 can comprise ashear pin1546. Thepin1546 is configured to shear by linear forces caused by the drive plate orsled1557 and the linear cylindrical drive shaft. The illustratedshear pin1546 has a plurality of elements extending through thedrive member1460. The elements are movably retained in aretainer member1544. Other retaining means can be employed to connect thedrive member1460 to thedrive assembly1540. Thedrive assembly1540 can comprise a toroidal drive system or transmission, or other type of drive system. The illustrated assembly has atoroidal drive system1541.
• FIG. 83 illustrates theinstrument1400 outputting irrigation fluid F (preferably a sterile fluid). Aninlet line1651 delivers the fluid to thesurgical file instrument1400. The fluid is transported by means of theadapter1652 via theinlet port1480. Theadapter1652 extends into the body housing and is in communication with thesupply tube1488. Theadapter1652 can be attached to various types of conduits or supply systems. In view of the present disclosure, theadapter1652 can be designed to couple temporarily or permanently to theinlet line1651. One end of theadapter1652 is connected to thedistal end1631 of theconduit1651. The other end ofadapter1652 is connected to aproximal end1621 of thesupply tube1488.
• Relatively large axial compressive forces can be applied to theadapter1652, especially because of its relatively small size, when conduits are connected and disconnected. Theadapter1652 can have a fitting structure to locate theadapter1652 relative to theouter housing1670. The illustrated fitting feature is in the form of acylindrical ring1653 configured to fit within a corresponding annular recess in theouter housing1670. The fitting structure can comprise one or more of the following: a ring, flange, recess, pin, and adhesives. The fitting structure can be positioned at any point between the ends of theadapter1652.
• Theadapter1652 operatively connects to thesupply tube1488. The fluid path continues running distally into the delivery lumen between thedrive member1460 and thedelivery tube1492. The fluid continues to flow distally until it is expelled out of theinstrument1400 at thedistal tip portion1404 and thru the tissue cutting holes. The pulsatile nature of the exiting fluid that is expelled directly thru the actual cutting teeth has several advantages. As detailed above, the fluid can cool the device mechanism or other moving components. The fluid can also lubricate the moving components of theinstrument1400. The fluid suspends the bone debris so it can be safely extracted from the tissue removal site by a surgical wand vacuum.
• With respect toFIGS. 84 and 85, apower device1650 is connected to aproximal adapter1641 of thesurgical file instrument1400. Thesurgical file instrument1400 can be driven by various types of electrical motors, power devices and other motor systems known in the art. Power devices can be rotary devices for driving thesurgical file instrument1400. Thepower device1650 can be small and light. In some cases, the small motors that can be used to power thesurgical file instrument1400 may become very hot to the touch. The surgeon can advantageously grip thesurgical file instrument1400 without touching the hot motor housing.
• The overall geometric shape of thesurgical file instrument1400 provides for comfortable gripping. As shown above inFIG. 86,surgical file instrument1400 can be designed to fit the human hand by a natural grip between thethumb1643 and anindex finger1644.
• The illustratedsurgical file instrument1400 has a body shape that is somewhat similar to the shape of a radish. The relaxed human hand generally features a curved opening between the thumb and index finger that fits the general shape and curve of an outer bodyhandle grip area1645 of thesurgical file instrument1400.
• The outer body of thesurgical file instrument1400 features finger grip depressions1646 (on both sides) that assist in adding hand traction without the tiring of a hard grip. This enables a surgeon to relax their grip and work in more comfort, and with better hand control and long term stamina. Indicia (e.g., the instrument name, trademark, etc.) can be featured in raised letters1647 (seeFIG. 85) in an area of the finger grip areas to improve grip traction. The illustrated instrument has raised indicia comprising SURGIFILE™ to improve traction. The superior grip and hand traction can be achieved even if the surgeon wears a glove. A wet surgical gloved hand can engage the indicia to enable the surgeon to have a good grip.
• FIG. 87 illustrates one embodiment of a blade of a surgical file instrument. Theblade1700 is perforated and comprises acutting zone1719. The illustratedcutting zone1719 comprises a plurality of cuttingelements1702. Thecutting elements1702 also define throughholes extending through theblade1700. As shown inFIG. 88, thecutting elements1702 extend outwardly from anupper face1706 of theblade1700. Thecutting elements1702 can have any configuration suitable for grinding, cutting, filing, or otherwise removing tissue. Ablade body1747 of theblade1700 is defined between theupper face1706 and alower face1741.
• The illustratedcutting elements1702 are raised elements that are somewhat conical in shape and definethroughholes1710. In some embodiments, an irrigation fluid can pass through thethroughholes1710 as discussed in detail above. Each of thecutting elements1702 can comprise one or more cutting edges for engaging tissue. In the illustrated embodiment ofFIG. 88, each of thecutting elements1702 comprises atip1733 that defines anouter cutting surface1720 and aninner cutting surface1722. As the cutting surfaces1720,1722 move along tissue, thecutting elements1702 remove tissue.
• Tips1733 of thecutting elements1702 can havecutting edges1742 for engaging tissue. The cutting edges1742 defineupper ends1751 of thethroughholes1710. The cutting edges1742 can be general parallel to theupper face1706 and/or thelower face1741 of theblade1700. The illustratedbody1747 has a somewhat arcuatetransverse axis1759, as shown inFIG. 88. The cutting edges1742 can be somewhat arcuate to match the curvature of thebody1747. In some embodiments, thecutting edges1742 are substantially concentric to the arcuatetransverse axis1759 of theblade1700. In alternative embodiments, thecutting edges1742 are substantially flat. Thus, thecutting edges1742 can be curved, flat, or combinations thereof. The cutting edges1742 are preferably capable of grinding, cutting, or filing tissue (e.g., bone or other somewhat hard tissue).
• The cutting edges1742 can be formed at the junction of thesurfaces1702,1722. In the illustrated embodiment, thetips1733 have a substantially V-shaped portion forming the cutting edges1742. However, thetips1733 can have other configurations. The cutting edges1742 can form substantially contiguous cutting edges.
• In alternatively embodiments, thecutting zone1719 does not comprise throughholes corresponding to each cutting element. For example, cutting elements, without throughholes, can extend from a substantial planar surface.
• Theblade1700 can be self-sharpening to retain effectiveness over extended periods of use. As thecutting elements1702 treat tissue (e.g., remove tissue), thecutting elements1702 generally do not become dull. In the illustrate embodiment, thecutting elements1702 are generally circular as view from above. However, in exemplary embodiments, thecutting elements1702 can be ellipsoidal, polygonal, or having any other shape and size suitable for treating tissue. The cutting elements may or may not define throughholes. For example, the blade may have throughholes spaced from the cutting elements.
• Theblade1700 can be formed by a punching process to form thecutting elements1702. Etching processes (e.g., chemical etching), machining, molding, or other manufacturing techniques can be employed to form thecutting elements1702.
• FIG. 89 is a cross-sectional view of the distal tip assembly of a surgical file instrument positioned to treat tissue of a patient. The distal tip assembly can be similar to the distal tip assembly ofFIGS. 69-72B.
• Adistal tip assembly1800 of the surgical file instrument comprises ablade1802 and a lower blade structure1810. The illustrateddistal tip assembly1800 is positioned between anerve1812 andtissue1814, although thedistal tip assembly1800 can be positioned at other treatment sites in a patient's body.
• In some embodiments, thedistal tip assembly1800 can be used to removetissue1814 in a form of vertebral bone made up of one or more facets. In the illustrated embodiment, thedistal tip assembly1800 is positioned to remove material from theinner periphery1816 of the vertebral bone.
• Theblade1802 can comprise anupper filing surface1820 configured to engage thetissue1814. Theblade1802 is configured to mate with the lower blade structure1810. Theblade1802 and the lower blade structure1810 can be configured to promote and guide movement of theblade1802. In some embodiments, including the illustrated embodiment, theblade1802 is slideably coupled to the lower blade structure1810. Theblade1802 and the lower blade structure1810 are convexed away from thefiling surface1820.
• The lower blade structure1810 can be configured to reduce or minimize trauma to thenerve1812. The lower blade structure1810 can define anatraumatic surface1830 suitable for contacting thetissue1812. In some embodiments, theatraumatic surface1830 is concaved towards thenerve1812. As such, thedistal tip assembly1800 can be positioned between thebone1814 and thenerve1812 without substantially traumatizing thenerve1812. That is, this atraumaticdistal tip assembly1800 is dimensioned so as to fit into a neuroforamen without appreciable trauma to a nerve extending through the neuroforamen. In some embodiments, thedistal tip assembly1800 can have a shape similar to the shape of the opening defined between thebone1814 and thenerve1812. The target tissue is removed by reciprocating theblade1802 while thedistal tip assembly1800 remains in the neuroforamen.
• Theblade1802 can have a transverse width that is generally similar to a transverse width of the lower blade structure1810. In some embodiments, theblade1802 has a transverse width that is greater than the transverse width of the lower blade structure1810. In some embodiments, theblade1802 has a width that is generally similar to the transverse width of the lower blade structure1810. In some embodiments, theblade1802 has a transverse width that is less than the transverse width of the lower blade structure. In some embodiments, theblade1802 can overhang or extend vertically along the edges of the lower blade structure1810.
• Theblade1802 can have a cutting zone. A plurality of cutting elements can define the zone which has a width that is generally similar to the transverse width of theblade1802. That is, the lateral most cutting elements on either side of theblade1802 can define a width that is substantially similar to the width of the lower blade structure1810. In some embodiments, the lateral most cutting elements of theblade1802 can define a width that is about 95%, 90%, 85%, 80%, 70%, 60%, or other percentages of the width of the lower blade structure1810. The cutting elements can therefore define an enlarged cutting zone for effectively and rapidly removing tissue from thebone1814.
• FIGS. 90 and 91 illustrate asurgical instrument2000 in accordance with another embodiment. Thesurgical instrument2000 has a curveddistal tip assembly2010 and is generally similar to thesurgical instrument1400, except as detailed below.
• Thedistal tip assembly2010 has ablade2014 positioned above alower blade structure2016. Thedistal tip assembly2010 has an angledsection2020. As shown inFIG. 92, theangle section2020 defines an angle θ. The angle θ is the angle between thelongitudinal axis2040 of the upper portion of thedistal tip assembly2010 and thedistal tip2050. The angle θ can be about 110 degrees, 120 degrees, 130 degrees, 140 degrees, or ranges encompassing such angles. Distal tip assemblies can also be at other angles or orientations. Such distal tip assemblies can be used for general bone sculpturing, for example. The illustratedinstrument2000 can be used to remove tissue from the spine or any other region of the body, such as a shoulder. For example, theinstrument2000 can be used remove tissue from the scapula, humerus, clavicle, cartilage or any other tissue. Theinstrument2000 can also be used in neuroforamina anywhere in the body, including the spine, skull, and other bones through which nerves extend. The shape and size of thedistal tip assembly2010 can be chosen based on the surgical procedures.
• Except as further described herein, the embodiments, features, systems, devices, materials, methods and techniques described herein may, in some embodiments, be similar to any one or more of the embodiments, features, systems, devices, materials, methods and techniques described in U.S. application Ser. No. 10/675,068 (U.S. Publication No. 2004-0122459) entitled SHIELDED RECIPROCATING SURGICAL FILE, filed Sep. 29, 2003.
• From the foregoing description, it will be appreciated that a novel approach for precision bone and/or tissue removal surgery has been disclosed. While the components, techniques and aspects of the invention have been described with a certain degree of particularity, it is manifest that many changes may be made in the specific designs, constructions and methodology herein above described without departing from the spirit and scope of this disclosure.
• Various modifications and applications of the invention may occur to those who are skilled in the art, without departing from the true spirit or scope of the invention. It should be understood that the invention is not limited to the embodiments set forth herein for purposes of exemplification, but is to be defined only by a fair reading of the appended claims, including the full range of equivalency to which each element thereof is entitled.

Claims (44)

1. A surgical instrument comprising:

a handle assembly; and

a distal assembly connected to said handle assembly, said distal assembly comprising:

a blade having a first width;

a lower blade structure having an upper face which has a second width extending between a first lateral side and a second lateral side, said blade being slidably coupled to said lower blade structure, wherein said first width is equal to or less than said second width.

2. The surgical instrument ofclaim 1, wherein said first width is at least about 95% of said second width.

3. The surgical instrument ofclaim 1, wherein said first width is at least about 80% of said second width.

4. The surgical instrument ofclaim 1, wherein said blade comprises an exposed cutting surface, said cutting surface configured to perform at least one of grinding, filing, and cutting of tissue.

5. The surgical instrument ofclaim 1, wherein said blade is axially movable along said lower blade structure.

6. The surgical instrument ofclaim 1, wherein at least a portion of said lower blade structure is tapered in said distal direction.

7. The surgical instrument ofclaim 1, wherein said distal assembly forms a minimally traumatic tip that is dimensioned so as to fit into a neuroforamen without appreciable trauma to a nerve extending through said neuroforamen.

8. The surgical instrument ofclaim 7, wherein said lower blade structure defines a shield on one side of said distal assembly, and said blade is disposed on another side of said distal assembly.

9. The surgical instrument ofclaim 1, wherein said blade and said upper face are curved about a long axis of said lower blade structure.

10. The surgical instrument ofclaim 1, wherein said lower blade structure defines a fluid delivery channel, said blade is axially moveable between a proximal position and a distal position, a window for expelling fluid at a distal end of said fluid delivery channel, wherein said window is defined between said blade and said lower blade structure when said blade occupies a proximal position.

11. A surgical instrument having a distal assembly, said distal assembly comprising:

a blade having a first blade edge and a second blade edge; and

a lower blade structure comprising an upper face between a first structure edge and a second structure edge, said blade being positioned upon said upper face and movable relative to said lower blade structure, and said first blade edge proximate to said first structure edge and said second blade edge proximate to said second structure edge.

12. The surgical instrument ofclaim 11, wherein said first blade edge and said second blade edge are opposing, longitudinally extending lateral edges of said blade, said first and second blade edges define a blade width,

wherein said first structure edge and said second structure edge are opposing, longitudinally extending lateral edges of said lower blade structure, said first and second structure edges define a lower blade structure width; and

wherein said blade width is equal to or greater than said lower blade width.

13. The surgical instrument ofclaim 11, wherein a blade width is defined between said first blade edge and said second blade edge, a lower blade structure width is defined between said first structure edge and said second structure edge, wherein said blade width is substantially similar to said lower blade structure width.

14. The surgical instrument ofclaim 11, wherein a periphery of at least a portion of said blade has a similar shape to a periphery of at least a portion of said lower blade structure.

15. The surgical instrument ofclaim 11, wherein at least a portion of a surface of said blade conforms to a periphery of at least a portion of said lower blade structure.

16. The surgical instrument ofclaim 11, wherein said lower blade structure has a shield surface opposing said upper face, and said shield surface forms a tip that curves towards said blade.

17. The surgical instrument ofclaim 11, wherein said lower blade structure has a shield surface opposing said upper face, and at least a portion of said shield surface is convex towards said blade.

18. The surgical instrument ofclaim 11, wherein said lower blade structure has a shield surface opposing said upper face, and at least a portion of said shield surface is concave towards a nerve extending through a neuroforamen, when said lower blade structure is positioned at least partially in said neuroforamen.

19. The surgical instrument ofclaim 11, wherein said lower blade structure has a shield surface opposing said upper face, and at least a portion of said shield surface is concave about a longitudinal axis of said lower blade structure.

20. The surgical instrument ofclaim 11, wherein said lower blade structure has a longitudinally extending fluid delivery channel disposed along said lower blade structure and a plurality of channels in communication with said fluid delivery channel.

21. The surgical instrument ofclaim 11, wherein said blade further comprises a plurality of throughholes, said blade and is movable between a proximal position and a distal position, at least one of said throughholes is positioned near said first structure edge and at least one of said throughholes is positioned near said second structure edge.

22. The surgical instrument ofclaim 21, wherein said lower blade structure further comprises an elongate delivery channel and a plurality of side channels, said elongate delivery channel extending along said lower blade structure, said plurality of side channels in communication with said delivery channel, wherein at least one of said side channels is aligned with at least one of said throughholes in the blade.

23. The surgical instrument ofclaim 11, wherein said distal assembly forms a tip that is dimensioned so as to fit into a neuroforamen without producing appreciable trauma to a nerve extending through said neuroforamen.

24. An instrument, comprising:

a blade having an upper filing surface; and

a lower blade structure, wherein said blade slidably couples with said lower blade structure, wherein said blade and said lower blade structure are each convex away from said upper filing surface.

25. The instrument ofclaim 24, wherein said distal assembly further comprises a tip, said tip dimensioned so as to fit into a neuroforamen without producing appreciable trauma to a nerve extending through said neuroforamen.

26. The instrument ofclaim 24, wherein said blade has a first transverse width and said lower blade structure has a second transverse width, wherein said first transverse width is about the same as said second transverse width.

27. The instrument ofclaim 24, wherein said blade has a first transverse width and said lower blade structure has a second transverse width, wherein said first transverse width is less than said second transverse width.

28. The instrument ofclaim 24, wherein said blade has a first transverse width and said lower blade structure has a second transverse width, wherein said first transverse width is greater than said second transverse width.

29. The instrument ofclaim 24, wherein said blade has a first transverse width and said lower blade structure has a second transverse width, wherein said first transverse width is less than about 95% of said second transverse width.

30. A surgical instrument comprising:

a filing surface configured to cut, grind, and/or file tissue;

a shield surface coupled to said filing surface;

wherein said instrument is configured to be positioned at least partially in a neuroforamen having a nerve extending therethrough; and

wherein at least a portion of said shield surface is concave towards said nerve when said instrument is positioned at least partially in said neuroforamen.

31. A surgical instrument comprising:

a filing surface configured to cut, grind, and/or file tissue; and

a shield surface coupled to said filing surface;

wherein at least a portion of said shield surface is convex towards said filing surface.

32. The instrument ofclaim 31, wherein said instrument is configured to be positioned at least partially in a mammalian neuroforamen having a nerve extending therethrough.

33. A surgical instrument comprising:

means for grinding a first tissue; and

means for shielding a second tissue from said means for grinding when said second tissue is in proximity to said first tissue;

wherein at least part of said means for shielding is convex towards said means for grinding.

34. A method of treating a patient comprising:

placing a distal assembly of an instrument at least partially in a neuroforamen having a nerve extending therethrough;

wherein at least a portion of said distal assembly is concave towards said nerve; and

removing tissue from said patient by operating said distal assembly.

35. The method ofclaim 34, wherein said removing of tissue comprises at least one of cutting, filing, and grinding.

36. The method ofclaim 34, further comprising oscillating a blade of said distal assembly to remove said tissue.

37. The method ofclaim 34, further comprising coupling a powered handpiece to said distal assembly of said instrument, and said powered handpiece has a drive system for driving a movable blade of said distal assembly.

38. The method ofclaim 37, wherein said powered handpiece is a rotary handpiece and said instrument further comprises a mechanical transmission that converts rotary motion of said powered handpiece to reciprocating, linear motion.

39. The method ofclaim 34, further comprising positioning an access device in a patient's body, and advancing said distal assembly through said access device until said distal assembly reaches a target location for tissue removal.

40. The method ofclaim 34, wherein tissue is removed by reciprocating a blade while at least a portion of said distal assembly remains in said neuroforamen.

41. A method of treating a patient, said method comprising:

placing a distal assembly of an instrument at least partially into a neuroforamen between target tissue and a nerve;

removing said target tissue from surrounding tissue with said distal assembly;

after removing said target tissue, drawing said target tissue into said distal assembly; and

moving said target tissue through said distal assembly.

42. The method ofclaim 41, wherein drawing said target tissue into said distal assembly comprises drawing said target tissue through an inlet port of said distal assembly and through a lumen extending from said inlet port through said distal assembly.

43. The method ofclaim 41, further comprising:

delivering irrigation fluid out of said distal assembly as said distal assembly removes said target tissue such that said irrigation fluid is mixed with said target tissue; and

drawing said mixture of target tissue and irrigation fluid into and through said distal assembly.

44. The method ofclaim 41, wherein said distal assembly is substantially L-shaped and has a cutting blade for removing tissue.

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