Detailed Description
The drawings illustrate the present invention as a surgical instrument having two portions such that the detachable instrument shaft portion may be disposable and the reusable handle portion may be sterilized and reused multiple times. This allows for a higher quality instrument handle portion while keeping the instrument reasonably priced overall.
The instrument of the present invention may be used to perform minimally invasive surgical procedures. By "minimally invasive procedure" is meant herein a procedure in which a surgeon performs an operation through a small incision or incision that is used to access a surgical site. In one embodiment, the length of the incision is in the range from 1mm to 20mm in diameter, preferably from 5mm to 10mm in diameter. This procedure is different from those requiring a large incision to access the surgical site. Therefore, it is preferred to use flexible instruments for insertion through such small incisions and/or through a body lumen or cavity in order to position the instrument at a target site within the body for a particular surgical or medical procedure. The introduction of the surgical instrument into the anatomical site may also be achieved by percutaneous or surgical access to a lumen, vessel or cavity, or by introduction through a natural orifice in the anatomical site.
In addition to use during laparoscopic surgery, the instruments of the present invention may be used in a variety of other medical or surgical procedures, including, but not limited to, colonoscopic, upper gastrointestinal, arthroscopic, sinus, thoracic, prostate, vaginal, orthopedic, and cardiac surgical procedures. Depending on the particular surgical procedure, the instrument shaft may be rigid, semi-rigid, or flexible.
Although referred to herein as "surgical instruments," it is contemplated that the principles of the present invention are also applicable to other medical instruments, not necessarily for surgery, and including, but not limited to, other instruments such as catheters and diagnostic and therapeutic instruments and implements.
There are a number of unique features that are embodied in the devices described herein. For example, a locking mechanism is provided which is constructed using a ball and socket arrangement disposed about a proximal motion member which moves with a bending action, and wherein a ring-shaped fastening ring (cinch ring) is used to hold the ball and socket arrangement in a fixed particular position, and thus also to hold the proximal and distal bendable members in a particular bent state, or in other words locked in that position. The cinch ring includes a locking lever that is conveniently located adjacent the instrument handle and easily manipulated to lock and unlock the cinch ring, and thus the position and unlocking of the end effector. The fastening ring is also preferably rotatable so that the locking bar can be conveniently positioned or can be switched (rotated) between left-handed and right-handed users. This locking control allows the surgeon to reduce one degree of freedom to focus on when performing certain tasks. This allows the surgeon to have more hands free by locking the bendable portion in a particular position to control other degrees of freedom of the instrument, such as manipulation of a rotation knob, which in turn controls the orientation of the end effector.
The main feature of the invention relates to the partly disposable and partly reusable nature of the apparatus. In this way, the cost of the instrument is greatly reduced since the entire instrument does not have to be replaced for each surgical procedure. In previous instrument configurations, the proximal bending member has been mounted directly to the rotation knob, but here the connector and associated receiver enable the bending member to be removed from the rotation knob. In one embodiment, a disconnect is provided at a location on the handle where the distal motion member, tool, instrument shaft and proximal motion member can be separated from the instrument handle. This enables the distal assembly to be engageable with, disengageable from, or releasable from the handle. Because the handle portion of the instrument is reusable, the cost of this portion of the instrument is substantially distributed over the use of multiple instruments.
FIG. 1 is a perspective view of one embodiment of a surgical instrument 10 of the present invention. Fig. 2-11 provide more detail of this embodiment. Figures 12-17 illustrate a second embodiment of the invention in which the instrument is adapted for use as a cauterization tool and employs a detachable tip. Fig. 18-20 illustrate a third embodiment of the invention in which the instrument is adapted for use as a rotary cutting tool.
In the embodiment of fig. 1, both the tool and handle moving or bendable members are bendable in any direction. They are interconnected by cables (preferably four cables) such that bending action at the proximal member causes an associated bend at the distal member. Proximal bending is controlled by movement or deflection of the control handle by the user of the instrument. In other words, the surgeon grasps the handle and, once the instrument is in place, any movement (deflection) at the handle immediately controls the proximal bendable member, and thus the corresponding bending or deflection at the distal bendable member, via the cable. This action in turn controls the positioning of the distal tool.
Preferably, the proximal member is generally larger than the distal member to provide enhanced ergonomic control. In the illustrated embodiment, the ratio of diameters of the proximal and distal bendable members may be on the order of 3 to 1. In one form according to the invention, a bending action may be provided in which the distal bendable member bends in the same direction as the proximal bendable member. In an alternative embodiment, the bendable, swivelable or flexible member may be arranged to bend in opposite directions by rotating the actuation cable through 180 degrees, or may be controlled to be able to bend in virtually any other direction, depending on the relationship between the proximal and distal support points of the cable.
As described above, the amount of bending motion produced at the distal bending member is determined by comparing the dimensions of the proximal bending member with the dimensions of the distal bending member. In such embodiments, the proximal bendable member is generally larger than the distal bendable member, and therefore the magnitude of motion produced at the distal bendable member is greater than the magnitude of motion at the proximal bendable member. The proximal bendable member may be bent in any direction (about 360 degrees) to control the bending of the distal bendable member in the same or opposite direction but in the same plane at the same time. Furthermore, as depicted in fig. 1, the surgeon is able to bend or rotate the tool of the instrument into any orientation about its longitudinal axis simply by rotating the axial rotation knob 24 about the rotational direction indicated by the rotation arrow R1 in fig. 1.
These members are referred to as bendable members in this specification. These members may also be referred to as swivelable members, bendable portions, or flexible members. In the description herein, terms such as "bendable portion," "bendable segment," "bendable member," or "swivelable member" refer to an element of an instrument that is controllably bendable as compared to an element that pivots at a joint. The term "movable member" is considered to be generic to bendable portions and joints. The bendable elements of the invention enable the manufacture of an instrument: can be bent in any direction without any singularity, and is further characterized by the ability to prepare for bending in any direction, all preferably with a single unitary or one-piece construction. The definition of "unitary" or "one-piece" structure is a structure constructed from only a single, unitary member, and not a structure formed from multiple assembled or mated components.
These bendable members are defined as instrument elements formed as control devices or controlled devices and capable of being forced by tension or compression to deviate from a straight line into a curved configuration without any significant break points or sharp corners. The bendable members may be in the form of a unitary structure, such as the type of proximal bendable member shown in FIG. 3 herein, may be constructed from engageable discs or the like, may comprise a bellows arrangement or may comprise a movable ring assembly. In fig. 2 herein, the unitary bendable structure includes a series of alternating flexible disks 130 defining slots 132 therebetween. An "integral" or "unitary" structure may be defined as a structure that is configured for use in a single piece and does not require assembly of parts. Connecting ribs 131 are shown extending between adjacent disks 130. Both bendable members preferably have the form of ribs, wherein the ribs are arranged in a manner that varies preferably by 60 degrees from one rib to the adjacent rib. For the various forms of bendable members, reference is made to co-pending application having application number 11/185,911 filed on 7/20/2005, application number 11/505,003 filed on 8/16/2006 and application number 11/523,103 filed on 9/19/2006, the entire contents of which are incorporated herein by reference.
FIG. 1 illustrates one embodiment of the instrument of the present invention. Figures 2 to 11 show more detail. Fig. 1 illustrates a surgical instrument 10 in perspective view, as may be present during a surgical procedure. For example, the instrument may be used for laparoscopic surgery through the abdominal wall 4. An insertion site provided with a cannula or trocar is provided for this purpose. The shaft 14 of the instrument 10 is adapted to pass through a cannula or trocar, shown schematically at 6, in order to position the distal end of the instrument at the surgical site. The end effector 16 is shown in FIG. 1. The embodiment of the instrument shown in FIG. 1 is generally used with a sheath 98 covering the distal member 20 to prevent bodily fluids from entering the distal bending member 20.
A separate sheath (not shown) may be temporarily used to cover the entire distal bendable member and end effector. Such a sheath is used only for transporting the instrument and is discarded once the instrument is in place on the handle. The sheath holds the jaws in an open position, as shown in FIG. 2, and also holds the distal bendable member in a substantially straightened position. For a more detailed construction of the temporary sheath, please see related application No.11/900,417 filed on 9, 11, 2007, which is hereby incorporated by reference in its entirety. In this way, the actuation cable is held in a particular aligned position and ready for engagement with the handle portion of the instrument. Instead of using a pre-formed sheath, optionally, a biasing means in the instrument can be used to hold the instrument cable in a predetermined position, typically a position in which the jaws are held open.
Rotation may be effected by the instrument of the present invention. This may be accomplished by rotating the rotation knob 24 about a longitudinal axis relative to the handle 12. This is indicated in fig. 1 by the rotation arrow R1. When the rotation knob 24 is rotated in either direction, this causes a corresponding rotation of the instrument shaft 14. This is indicated in fig. 1 by the rotation arrow R2. This motion also causes the distal bendable member and end effector 16 to rotate about an axis corresponding to the instrument tip, shown in FIG. 1 as rotating about the longitudinal tip or tool axis P. See rotation arrow R3 at the instrument tip in fig. 1.
Any rotation of the rotation knob 24 when the instrument is locked (or unlocked) will cause the instrument tip to remain in the same angular position, but will cause the orientation of the tip (tool) to rotate. To further illustrate the rotational nature of the tip, reference is made to co-pending application No.11/302,654 filed on 12/14/2005, particularly FIGS. 25-28, which is hereby incorporated by reference in its entirety.
The handle 12 may be angled away from the instrument shaft longitudinal central axis by the proximal bendable member 18. This tilting, deflecting or bending is three-dimensional. This action causes, via the cable, a corresponding bending at the distal bendable member 20 to a position where the tip is directed along an axis and at a corresponding angle to the instrument shaft longitudinal central axis. The surgeon controls the bending at the proximal bendable member 18 from the handle 12 by manipulating the handle in substantially any direction, including directions into and out of the plane of the paper in FIG. 1. This manipulation directly controls the bending at the proximal bendable member. For further explanation regarding the flexing and locking features, reference is made to co-pending application Ser. No.11/528,134 filed on 27.9.2006 and application Ser. No.11/649,352 filed on 2.1.2007, which are hereby incorporated by reference in their entirety.
Thus, control at the handle is used to bend the instrument at the proximal motion member, thereby controlling the positioning of the distal motion member and the tool. The "position" of the tool is primarily determined by this bending or motion action and may be considered as the coordinate position at the distal end of the distal motion member. Indeed, it is contemplated that there may be coordinate axes at the proximal and distal motion members and the instrument tip. This positioning is three-dimensional. Of course, instrument positioning is also controlled to some extent by the surgeon's ability to pivot the instrument at the point of the incision or at the cannula or trocar. On the other hand, "orienting" the tool involves rotationally positioning the tool about the illustrated distal tip or tool axis P from the proximal rotational control member (knob 24).
A set of jaws is shown in the drawings, but other tools or devices may be readily adapted for use with the instrument of the present invention. These include, but are not limited to, cameras, detectors, optics, scopes, fluid delivery devices, syringes, and the like. The tool may include various articulating tools, such as: jaws, scissors, clamps, needle holders, microdissectors, stapler applicators (stapleappliers), patches (tacks), suction irrigation tools, and clip appliers. Further, the tool may comprise a non-articulating tool, such as: cutting blades, probes, irrigators, catheters, or suction nozzles.
The surgical instrument of fig. 1 illustrates one embodiment of a surgical instrument 10 according to the present invention, which is in use and is insertable through the skin of a patient via a cannula at an insertion site. Many of the components shown herein, such as the instrument shaft 14, end effector 16, distal bending member 20, and proximal bending member 18, may be similar to and interact in the same manner as the instrument components described in co-pending U.S. application No.11/185,911 filed on 7/20 2005, the entire contents of which are hereby incorporated by reference. Some of the other assemblies shown herein, particularly the assembly located at the handle end of the instrument, may be similar to that described in co-pending U.S. application No.11/528,134 filed on 27.9.2006, the entire contents of which are hereby incorporated by reference. The following applications are also incorporated by reference in their entirety: U.S. application No.10/822,081 filed on 12.4.2004, U.S. application No.11/242,642 filed on 3.10.2005, and U.S. application No.11/302,654 filed on 14.12.2005, all of which are commonly owned by the present assignee.
For example, as shown in FIGS. 1-3, control between the proximal bendable member 18 and the distal bendable member 20 is provided by a bend control cable 100. In the illustrated embodiment, four such control cables 100 may be provided to provide the desired bending in various directions. However, in other embodiments of the invention, a lesser number of bend control cables may be employed. The bend control cables 100 extend through the instrument shaft 14 and through the proximal and distal bendable members. The bend control cable 100 may be constrained along substantially its entire length so as to facilitate "push" and "pull" actions, as described in further detail in co-pending application No.11/649,352, filed on.1-2 of 2007. The cables 100 are preferably constrained as they pass through the conical cable guide portion of the proximal bendable member and through the proximal bendable member itself.
The locking means interacts with the ball and socket arrangement to lock and unlock the positioning of the cable, which in turn controls the angle of the proximal bending member and thus the angle of the distal bending member and end effector. This locking control allows the surgeon to have one less degree of freedom to focus on when performing certain tasks. By locking the bendable portion in a particular position, the surgeon is enabled to more free hands to control other degrees of freedom of the instrument, such as manipulation of the rotation knob 24 and, in turn, manipulation of the orientation of the end effector.
The instrument shown in fig. 1 is considered to be of the pistol grip type. However, the principles of the present invention are also applicable to other forms of handles, such as linear handles. In fig. 1, a jaw clamping or actuating device 30 is shown that basically comprises a rod 22, which rod 22 may have a single finger hole in a gimbaled ball 27. A ball 27 is mounted on the free end of the rod 22. The surgeon controls the rod 22 with the ball 27. In an alternative embodiment, the ball 27 is optional, instead of it being a simple through hole or blind hole at the free end of the rod 22. There may also be an associated release function controlled directly by the lever 22 or by a separate release button. The release function is used to release the tip of the instrument for interchange.
In the illustrated instrument, when the proximal bendable member is constructed and arranged to preferably enable a full 360 degree bend, the handle end of the instrument may then be tilted or deflected in any direction. This movement of the handle relative to the instrument shaft bends the instrument at the proximal bendable member 18. This action, in turn, causes the distal bendable member to bend in the same direction by bending the control cable 100. As previously mentioned, the opposite direction of bending may be obtained by rotating the control cable through 180 degrees or twisting it through 180 degrees from one end to the other.
In the main embodiment illustrated herein, the handle 12 is in the form of a pistol grip and includes a horn 13 to facilitate a comfortable interface between the action of the surgeon's hand and the instrument. Fig. 1 shows the tool actuation lever 22 pivotally attached at the base of the handle. The lever 22 actuates a linkage that controls a tool actuation cable 38 (see fig. 2 and 3). The cable 38 controls the opening and closing of the jaws, and the different positions of the lever control the force applied to the jaws.
The instrument 10 has a handle portion 12 and a detachable shaft portion 14, as shown in fig. 1. Many of the components of the instrument are similar to those shown in application No.11/649,352 filed on 2.1.2007, particularly the configuration of the bendable member, the instrument shaft, the end effector, the rotation member, and the locking mechanism. The instrument 10 includes means for enabling the shaft and proximal bendable member to rotate within the bearing means or bearing surfaces 208 and 210 (fig. 3). Bearing 208 is coupled between adapter 26 and ball 120, while bearing surface 210 is located between neck portion 206 and the instrument shaft. The separate portions 12 and 14, or alternatively the assembled device, may be sealed in a sterile package or packages prior to storage or shipment.
Reference is now also made to co-pending application No.11/900,417 filed on 11/9/2007 (the entire contents of which are incorporated herein by reference) for an illustration of a related instrument structure including a releasable shaft. The present invention is directed to other features, particularly those relating to locking devices for shafts and for cable joints. The locking means for the cable is driven by the actuating lever and includes a spring-loaded compensation means or member 152 (see fig. 5) for applying a constant jaw pressure to tools or tissues of different thicknesses and a ratchet arrangement 154 to maintain the applied pressure. The members 152 and 154 are discussed in further detail below.
Fig. 2 shows the instrument in a rest position, wherein the distal part of the instrument comprises the instrument shaft 14, the instrument shaft 14 being joined to the proximal part of the instrument comprising the control handle 12. On the other hand, fig. 3 shows the instrument in a use position, in which the lever 22 is at least partially depressed (moved in the direction of arrow 22A towards the handle). In both views, the distal portion of the instrument is engaged with the proximal portion of the instrument and the actuation cables are considered to be interlocked or engaged such that operation of the lever 22 controls movement of the actuation cables and thus actuation of the end effector 16. FIG. 4 is an exploded, partial cross-sectional view showing the distal end portion (instrument shaft portion) of the instrument removed from the control handle (instrument handle portion).
As shown in fig. 4 and 8, the shaft portion 14 can be easily separated from the handle portion 12 by releasing the fastening ring 200. For more details on axial portion release, please refer to co-pending application No.11/900,417 filed on 9, 11, 2007. The shaft portion 14 includes a shaft connector 212 (see fig. 4). The proximal flange 210 of the shaft portion 14 is captured in the shaft receiver portion 34 of the rotation knob 24. The clamping block 182 captures the proximal flange 210. The shaft connector 212 is linearly locked, but the shaft locking device or member 150 allows the shaft portion to rotate relative to the handle portion. The cable lug 40 is captured by its engagement with the cable engagement means 84.
The instrument includes an angle locking device 140 as shown in fig. 1-4. The angle locking arrangement includes a split hub 202, the split hub 202 being constructed and arranged to enable the ball 120 and the entire distal shaft portion to be pulled out of the split hub 202. The fastening ring 200 is used to lock and unlock the split hub 202, as described in more detail later, and as further described in co-pending application No.11/900,417 filed on 9, 11, 2007.
The split hub 202 comprises a plurality of portions or hub lobes, each preferably having a tapered surface to act as a ramp (ramp) to force the hub lobes apart when the ball 120 is pushed proximally against the ramp during insertion of the shaft portion into the handle portion. These inward facing surfaces or edges of the sections are sloped or tapered to enable easier passage of the ball. The split hub 202 is supported by the handle through a bracket 230, the bracket 230 being thinned to act as a flexible living hinge, allowing the hub petals to more easily expand. This structure facilitates engagement and disengagement between the shaft portion and the handle portion.
The fastening ring 200 may have two flanges that straddle (ride) within corresponding circumferential grooves provided on the outer surface of the split hub 202. This interface captures the fastening ring while allowing the split hubs to separate along a line. The fastening ring 200 is substantially controlled by the angle locking member or means 140. The angle locking member 140 is pivotably attached to the fastening ring 200. The angle locking member 140 basically includes a release/lock lever 220 that controls the length or outer circumference of the fastening ring 200. The angle locking member 140 is configured and arranged to enable the fastening ring 200 to not only be slack enough to adjust the angle of the shaft relative to the handle but also be expandable to a size sufficient to allow the split hub portion to expand sufficiently to enable removal or insertion of the ball 120 (and the entire distal shaft portion) from or into the split hub 202. This enables the shaft portion to be easily disengaged from the handle portion. For further details of the construction of the fastening ring, please refer to co-pending application Ser. No.11/649,352 filed on 2/1/2007 and Ser. No.11/900,417 filed on 11/9/2007.
The fastening ring 200 is operated by an eccentric locking lever 220, and the eccentric locking lever 220 is connected to the end of the fastening ring 200 by a corresponding pin. When the rod 220 is released, the fastening ring 200 is free to rotate about the split hub 202. This allows the instrument to be operated with either the left or right hand. When the locking lever 220 is moved to its locking position, this causes the tightening ring 200 to be compressed and contract, closing the hub against the spherical outer surface 204 of the ball member 120. This locks the handle against the ball member 120, thereby holding the ball member 120 in whatever position the ball member was in when the locking occurred. This also holds and secures the proximal bendable member in a particular position by holding the ball member in a fixed position. This in turn holds the distal bendable member and tool in a fixed position, but the instrument orientation can be controlled by controlling a rotation knob that controls the orientation of the instrument tip by rotating the distal bendable member and tool about the tip axis P (see FIG. 3).
Another feature of the instrument of the first embodiment is the use of a separate shaft release lever 160 as shown in fig. 2 and 3. The lever 160 operates a linkage mechanism, which in turn controls the shaft locking member 150. The sleeve 176 is controlled by a linkage mechanism and controls the opening and closing of the clamping blocks 182. These clamping blocks 182 capture the post 214 and the entire shaft portion. In an alternative embodiment, the gripping blocks can capture the cable in different ways, such as by having a projection on each gripping block engage a slot or hole in the cable.
The instrument of the present invention provides the ability to reuse the handle portion of the instrument while the distal portion or shaft portion is disposable or replaceable. This is achieved by providing a disconnect means substantially at the proximal bendable member. For example, as shown in FIG. 4, the shaft portion 14 includes a shaft connector 212 attached to the proximal bendable member 18. It is the shaft connector 212 that is engageable with or releasable from the receiver portion 34 of the rotation knob 24. The shaft connector 212 may be seated in the receiver portion 34 of the rotation knob and bolted to the rotation knob 24 through splines 238 of the connector 212 and grooves 240 in a seat 246 of the receiver portion 34. See also fig. 8 and 9 for further details. The reduced diameter portion 242 of the shaft connector 212 passes through the clearance hole 244 in the seat portion 246 of the receiver portion 34 and abuts the clamping block 182 (see FIG. 6), which when closed, loosely fits around the post 214 extending proximally through the semi-circular bore 184. The proximal flange 210 at the end of the post 214 is relatively loosely captured by the clamping blocks, allowing the shaft connector 212 to rotate but not allow axial movement thereof. Reference is made to fig. 7 and 9.
The proximal end of the push/pull cable 38 is attached to a tube 39, the tube 39 being free to slide within the internal bore 41 of the post 214, as shown in FIG. 5. The tube 39 can be attached to the cable 38 in any of a number of different ways, such as by adhesive, welding, or tying. Tube 39 is not shown as being biased in any particular direction (proximally or distally), but tube 39 may be spring-loaded proximally or distally to bias the jaws (or other end effector) to a desired "rest" position. For example, as in fig. 5, a spring may be disposed in the hole 41. The tube 39 has a nipple 40 adapted to be captured by the cable engagement means 84. The cable engagement member 84 basically includes a door 260. The door 260 at the handle portion is controlled by the actuation lever 22. The adapter 40 has a tapered portion 42 to facilitate insertion of the shaft into the handle and to provide clearance for the door 260. When the lever 22 is initially grasped and the carriage 82 is pulled proximally, the door 260 catches the tab 40, as best shown in fig. 5A, with the notch 271 of the door 260 engaging the tab 40. The door 260 moves up and down within a guide slot 262 in the carriage 82. As best shown in fig. 11, the door is biased to the closed position by a spring 264. The spring is retained by an arm 266 that is threaded down to the top of the carriage 82. The lower end of the spring is seated in a well 268 in the door. When the door is in the closed position, two semi-circular flanges 270 with gaps 271 between them extend into a central aperture 272 in the carriage 82, capturing the cable lug 40 in the gap between the flanges.
As shown in fig. 11, the bore 272 has a taper 274 at its distal end to guide the adapter 40 into position when the shaft is inserted into the handle. The gate 260 bottoms out at a location 276 corresponding to the end of the guide slot 262 to allow a radial clearance between the flange 270 and the tube 39 to allow the joint and tube to rotate freely within the carriage 82. The ramp 278 on the door 260 interacts with the cam block 86 at the distal end of carriage travel to push the door open when the lever 22 is at rest to release the joint 40. This means that the cable lug 40 generally allows removal of the shaft whenever the lever 22 is released or parked, such as in the position shown in fig. 4.
When the lever 22 is grasped, the carriage 82 is pulled proximally in the direction of arrow 279 (see fig. 3, 5A, 6, and 11), the ramp 278 slides down the cam block 86, the proximal flange 270 rides over the tapered edge 42 of the joint 40, and the distal flange 270 contacts the distal surface of the joint 40. This action causes the joint 40 to begin to be pulled in the direction 279. When the stroke reaches approximately the position of FIG. 11, the ramp 278 drops off of the cam block 86 and the cable lug 40 is fully captured. Further gripping of the lever 22 toward the handle causes operation of the ratchet device 154. The lever 22 can then be fully gripped to release the ratchet member 154 and the cable engagement device 84. This action returns the carriage 82 under bias from the spring 71 until the tapered portion 274 of the carriage rides over the tapered portion 216 of the flange 210, thus aligning the engagement means 84 with the nipple 40.
The compensating device 152 best shown in fig. 5 and 6 will now be described. The compensation member 152 provides a biasing force while accommodating different sized needles or other objects located at the end effector. For simplicity, the compensation means are not shown in fig. 1-4. The compensating device or member mainly comprises a link 79 constructed of two relatively sliding portions 79A and 79B. The link 79 is supported in a guide 290 on the portion 79A so that the portion 79A can be biased proximally toward the portion 79A by a spring 292. A shoulder 294 on portion 79B acts as a stop. As shown in fig. 2 and 3, one end of the connecting rod 79 is supported by the crank 76 at pin 80, while the opposite end is supported by the carriage 82 at pin 81. The crank 76 pivots at pin 78. The connecting rod 74 is attached to the crank 76 at pin 77 and is located intermediate the pins 77 and 78. The pin 80 supports the connecting rod 79 from the crank 76. When the lever 22 is gripped, the jaws 44, 46 of the end effector 16 approach the needle 45. After contacting the needle, link portion 79A stops moving while portion 79B continues to be pulled in the proximal direction under the tension of spring 292, thereby applying a constant clamping force to the jaws while compensating for the thickness of the needle.
The ratchet mechanism 154 includes a spring-loaded pawl 156 that acts on a rack 158 in a one-way ratcheting manner. A rack 158 is secured to the inner surface of the handle. Note that in fig. 2 and 5 the pawl 156 has not yet engaged the rack 158. Fig. 3 shows the lever substantially depressed and the pawl 156 near the end of its travel. The pawl moves along the rack until it passes the rack, which is the condition just past the position shown in figure 6. The pawl 156 is then free to pivot past the teeth of the rack 158 and thereby release the crank 76 to return it to the starting position of fig. 5 under the action of the lever return spring 71. Once the pawl has passed the end of its travel, it automatically returns to the position of figure 5 under the control of the return spring 71. This action also opens the door 260, allowing the more distal shaft portion to be released.
Shaft portion release
The fastening ring 200 is released so the ball 120 of the shaft portion 14 can be pulled out of the split hub 202. The fastening ring is released by the operating rod 220. Shaft locking device or member 150 is released by pushing lever 160 at the base of the handle in the direction of arrow 161 shown in fig. 3, causing lever 160 to pivot in a clockwise direction about pivot post 162. This action is transmitted through a linkage 164, with one end of linkage 164 connected to lever 160 by pin 166 and the opposite end connected to bell crank 168, with bell crank 168 connected to linkage 164 by pin 169 (see fig. 5). When the lever 160 is actuated, the bell crank 168 pivots counterclockwise about the pin 170 and the slot 171 in the bell crank drives the pin 172, which in turn drives the bracket 174 in the distal direction of the arrow 163 as shown in FIGS. 4, 5, 7 and 9. Bracket 174 (see also fig. 10) is mounted to rectangular sleeve 176 by screws or rivets 175. The sleeve 176 has a ramped notch 178 (see fig. 9 and 10) that acts against a pin 180 mounted in a clamping block 182. This action causes the gripping blocks 182 to separate (splay apart) in the direction of the arrows 165 shown in fig. 7 and 9. The clamping block 182 is prevented from lateral movement by guide pins 186 that ride within bores 188 in the clamping block. The guide pin 186 is supported on the arm 90 (see fig. 5 and 6), and the arm 90 is fastened to the support pipe 94 in a fixed position by the guide pin 91 and the screw 92. The guide pin 186 passes through a slot 190 in the sleeve 176, as shown in fig. 11.
Top arm 90 also supports post 88, and cam block 86 is mounted on post 88. The post 86 also passes through a slot 190 in the sleeve 176. The opening of the clamping block 182 leaves the proximal flange 210 of the shaft connector 212 clear so that it is withdrawn through the channel formed by the semi-circular internal bore 184 in the clamping block (fig. 7 and 9). The shaft connector 212 can then be removed from the shaft receiver portion 34 of the rotation knob 24 while the ball portion 120 of the shaft is pulled out of the split hub 202, as shown in fig. 4 and 7-9.
Shaft portion insertion
The following description relates to the insertion sequence of the shaft portion 14. When the shaft portion is inserted, the ball 120 passes over the distal edge of the split hub 202. The distal edge may be tapered as shown in fig. 4 to facilitate insertion and provide some guidance. The shaft connector 212 is guided into position by at least the taper 36 on the shaft receiver portion 34 and the taper 239 on the splines 238 of the shaft connector 212. Fig. 6 and 8 also show how tapered portion 216 of proximal flange 210 facilitates insertion by engaging tapered portion 274. In addition, each clamping block 182 is provided with a taper 183 to facilitate alignment of the shaft portion 14, as shown in fig. 9. These various tapers help center the cable lug 40 as it passes into the carriage 82, as illustrated in fig. 7.
When the end of the spline 238 contacts the seat 246 (see fig. 9), the shaft portion 14 can then be rotated until the spline 238 is aligned with the groove 240. Shaft connector 212 may be inserted all the way into receiver portion 34 until seat 246 prevents further proximal movement by contacting shoulder 248 of connector 212. The shoulder 250 of the shaft connector 212 simultaneously contacts the face 252 of the clamping block 182. The shaft release lever 160 can then be pulled proximally (in the direction opposite to arrow 161 in FIG. 3), causing the sleeve 176 to move proximally in the direction of arrow 167 in FIG. 10, thereby closing the clamp block 182 about the post 214, thereby capturing the annular flange 210. The closing and capture of the flange 210 is illustrated by the arrows 173 shown in fig. 10 and 11. The release lever 160 may be provided with a detent means to hold it in a clamped or released position so that the shaft portion is not released by mistake. Once the shaft portion 14 is captured in the handle portion 12, actuation of the end effector may be controlled with the lever 22. For example, fig. 3 shows the lever at least partially depressed and the carriage 82 moved proximally and the jaws 44, 46 closed to grip the needle 45.
Cauterization tool embodiments
Figure 12 illustrates an alternative embodiment of the present invention in which the instrument 310 is particularly suited for use in intraoperatively performed cauteries. More details are shown in fig. 13-17. This embodiment also provides an alternative shaft with a different release mechanism, as described below. In the previous embodiment described herein, a set of jaws is shown. In this embodiment, the end effector has been replaced with a collet mechanism 316, the collet mechanism 316 releasably grasping the cautery tool 320 and providing an electrical connection to an electrical contact 322 (see fig. 12B) of the tool for enabling selective triggering of the cautery tool. The cable 38 is used to clamp the collet 316 and provide electrical current to heat the cautery tool. The cable is split into two portions, one portion 38A integral with the shaft 314 and electrically insulated by a sheath 315 (see fig. 12B), the sheath 315 also preferably being constructed of a low friction material to enable the cable to slide easily within the sheath 315. The cable portion 38B also has an insulating sheath 317 (see fig. 13). The cable portion 38B passes through the sheath 317 and its more proximal end is connected to the slider 28 at the sleeve 66.
The interior of the handle is not shown in detail here, but earlier applications that have been incorporated by reference herein disclose more details of the slider and sleeve arrangement that can be used to actuate the cable 38. See, for example, application No.11/185,911 filed on 20/7/2005; application No.11/302,654 filed on 12/14/2005; application No.11/505,003 filed on 8, 16.2006; no.11/528,134 filed on 27/9/2006 and No.11/649,352 filed on 2/1/2007. In an alternative embodiment, the sleeve 66 may not be needed and the cable may be clamped directly to the slider, since the cable 38A is free to rotate independently at the connector 384. The proximal end of cable 38B then passes into a handle extension 324 attached to the end of handle 12. Handle extension 324 houses a tubular electrical contact 326, electrical contact 326 allowing the cable to slide proximally and distally while maintaining an electrical connection with a variable voltage source 328, variable voltage source 328 in turn being connected to contact 326 at node 330 by a flexible cable 332. A switch (not shown) may be conveniently supported at or adjacent the extension or variable voltage source to enable selective application of voltage to the tool 320.
The collet mechanism 316 is shown in fig. 12A and 12B, and the collet mechanism 316 is used to receive tools 320 of different sizes, shapes, types, etc. Depending on the particular surgical procedure, the tools are typically arranged in a curved configuration. According to the invention, it is not necessary to use a different overall instrument for each type, a single instrument can be used, and different instrument tips can be exchanged only at the tip of the instrument in order to change the tool type, size or shape. The collet 360 is made of an electrically insulating material such as hard plastic and is attached to the distal bendable member 20 and the distal end of the cable 100. The jaws 364 are activated to grip and release the tool 320. Four such jaws are used in the disclosed embodiment, however, it should be understood that a different number of jaws may be employed. The base 362 of the jaw 364 houses electrical contacts 366 that may be soldered to the distal end of the cable 38A. The contacts 366 mate with the contacts 322 on the cautery tool. As shown in FIG. 12B, the base 362 may be constructed of a metallic material and may be soldered at 368 to provide further electrical contact between the cable 38A and the contact 322 of the cautery tool.
The cautery tool is adapted to be grasped and released by the collet and jaw arrangement shown in fig. 12A and 12B. The clamping or release is controlled by an actuation cable 38. Because the cautery tool is a non-articulating tool, there is no need for a main cable for tool actuation, which is used to selectively capture the cautery tool itself. Cauterization tool 320 is advanced into the relaxed jaws until contact 322 of the tool bottoms out against contact 366 within base 362. The lever 22 can then be gripped (depressed inward toward the handle) causing the cable 38A to pull the jaws 364 into the collet 360. The relative movement between the jaws and the collet substantially tightens the jaws closed against the tool. This is shown in the direction of arrow 369 in fig. 12B. The cautery tool is thus secured within the collet 360 and electrically connected to the voltage source 328. The electrically energized jaws 364 and contacts 322 are recessed from the distal end of the insulative collet 360 to prevent electrical shock to the patient. The lever 22 may be provided with one or more positioning means enabling the lever to be held in a particular desired position, either locked or released.
This embodiment of the invention also discloses an alternative method of engaging a shaft portion of an instrument. An alternative cable engagement device or member 284 is shown in fig. 13-17. This embodiment also shows the proximal bendable member 18 having ribs that define adjacent slots in the aforementioned instruments as shown in the applications incorporated herein. Many of the components in this embodiment are the same as shown in the first embodiment herein, such as the shaft connector 212, the ball 120, the rotation knob 24, and the proximal flange 210. Primarily, the optional cable engagement member 384 is discussed in further detail herein. In the first embodiment described herein, the capture of the shaft portion involves action at a release lever 160 located at the proximal-most end of the handle. In this second embodiment, a separate member is employed that includes a cable release button 388 and a release lever 430. The button 388 is used to engage the contact between the cable segments, while the lever 430 is used to lock the shaft portion 314 in place relative to the handle.
As shown in fig. 13 and 15, a slidable sleeve 386 is supported within a handle support tube 394. The sleeve 386 functions as a collet that controls the clamping fingers 392, which is connected to and operated by the release button 388. The sleeve 386 is slidable proximally and distally within a support tube 394 formed as part of the handle. A tapered portion 387 (see also fig. 16 and 17) at the distal end of the sleeve 386 opens or closes the fingers 392 around the joint 340. The sleeve 386 functions as a slide for the connector 390 when the cable 38B is pulled or released by the lever 22 during engagement or release of the cautery tool. The fingers 392 may be made of a metallic material for electrical conduction with the tab 340. As shown at 395 in fig. 13, the base 393 of the finger 392 may be welded to a metal core 396, the core 396 is welded at 397 to the exposed end of the cable 38B. Electrical contacts in the form of springs 398 may be attached to the core 396 to ensure good electrical contact with the metal fitting 340, and the metal fitting 340 may be soldered to the cable 38A or attached in any other suitable manner. The plastic insert 400 having a notch 402 for receiving the finger 392 includes a seat 404 (see fig. 17) for engaging the taper 342 on the fitting 340.
The inserter 400 also has a taper 406 at the distal end (see fig. 17) to aid in the alignment of the hub 340 with the connector 390 when inserting the shaft into the instrument. As can be seen in fig. 16, the cable lug 340 is free to rotate within the connector 390 but remains in electrical contact with the cable 38B. The release button 388 is attached to the sleeve 386 through a narrow neck 408 (fig. 15), the narrow neck 408 protruding through a slot 410 in the handle. The release button 388 slides in and out of a recess 412 in the top of the handle just behind the horn 13. The button 388 tab 413, in both the locked and unlocked positions the tab 413 snaps into the detent 414 in the recess 412. When the button 388 is pulled in the direction 389 depicted in fig. 15, this action pulls the sleeve 386 back from the fingers 392, spreading the fingers apart, thereby providing clearance for removal or insertion of the fitting 340. When in this outer or extended position, the button 388 protrudes significantly above the surface of the handle, as shown in solid outline in FIG. 15, as a clear indication that the cable is not locked in place. If the button 388 is moved distally, this action causes the sleeve 386 to slide against the connector 390 and thereby lock the cable at the fingers 392, as shown in solid outline in FIG. 13.
An alternative embodiment of a shaft locking device is shown at 350 and will now be described as shown in FIGS. 12-15. Instead of the clamping blocks closing around the neck 214 as in the first embodiment described herein, a gate 420 with a semi-circular edge 422 (see fig. 14) captures the flange 210 on the shaft connector 212. The door 420 spans a guide slot 424 formed in the support tube 394. A stop 426 (see fig. 15) at the bottom of the notch keeps the edge 422 from contacting the post 214. A boss 428 on the top of the door 420 is connected to the release lever 430 by a pin 432. The lever 430 is seated in a slot 434 on the underside of the horn 13 and pivots on a pin 436. The tab 438 on the lever 430 snaps into a detent 440 on the side of the slot 434 in both the unlocked and locked positions. The lever 430 may be used by inserting a thumb nail at the top of the slot and pushing down. When the lever is in the unlocked position, shown in phantom in fig. 13 and in solid lines in fig. 15, it is clearly indicated that the shaft is not locked in place. When both the button 388 and the lever 430 are in their recessed positions, the instrument is ready for use.
Rotary cutting tool embodiments
Fig. 18 illustrates an alternative embodiment of a surgical instrument for use as a rotary cutting tool. Additional details are shown in fig. 18A, 18B, 18C, 19 and 20. The end effector 516 has a collet clamping mechanism 516 that holds a tool, such as a rotary cutter 520 in this particular embodiment. It will be appreciated that other forms of rotating tools may be used as well as other forms of stationary tools. Collet clamping mechanism 516 allows collet 560 and cable portion 38A to rotate freely. The cable portion 38A passes through a low friction sheath 515 (see FIG. 18B) in the main instrument shaft and is connected to the cable portion 38B by a cable engagement device or member 584. The mechanism 584 rotatably and laterally bolts the two cable portions together. The cable portion 38B then passes through a low friction sheath 517 (see fig. 18) in the stiffening tube 64 to the slider 28, except where the stiffening tube and sheath end lacks the sleeve 66. The exposed cable is then clamped to the sleeve 66. The sleeve 66 is made of a low friction material so that the sleeve 66 can rotate freely within the slider 28 when the cable 38B is driven by the motor 526. The cable 38B is then threaded through another short section of the sheath (not shown), through the end of the handle to a splined chuck 522 on the motor shaft 524 of the motor 526. The cable is connected to the chuck 522. The spline chuck 522 allows limited lateral movement of the cable while transmitting rotational force from a motor, which may be battery powered or externally connected to a power source and may be controlled by a switch 528. The motor 526, switch 528, and battery and/or external power connectors are housed within the housing extension 530.
The collet mechanism 516 shown in fig. 18A-18C will now be described. The mechanism is used to lock and/or release a tool at the distal tip of the instrument. For this purpose, the collet 560 is supported in bearings 562 within a housing 564, which housing 564 is in turn connected to the distal bendable member 20 and the cable 100, as shown in FIG. 18B. The four jaws 566 grip the tool 520 when the cable 38A, secured to the jaw base 568 by the square fitting 570, is pulled by gripping the lever 22. This action draws the tool into the collet to securely hold the tool. The lever 22 may be provided with one or more positioning means enabling the lever to be held in a particular desired position, either locked or released. The tool 520, shown as a rasp, may then be rotated at high speed by the motor 526.
Fig. 18-20 illustrate a cable locking device or member 584 that is similar to the cable locking device 384 but instead transmits rotational force from the cable portion 38A to the cable portion 38B, rather than electrical current. Connector 590 is supported and operates by a slidable sleeve 586 and a tapered portion 587 similar to sleeve 386 and tapered portion 387 shown in the previous embodiments of fig. 12-17. Fingers 592 are supported by base 593. These fingers 592 have slightly raised rims 594 and 595 that act as bearing surfaces against the sleeve 586. They are primarily used to reduce rotational friction when the connector is rotated within the sleeve when the motor is running. They can be made of metal or plastic, since they do not have to have current through them.
The fingers and base are mounted on a core 596 of metal or plastic material, which core 596 is fastened to the end of the cable portion 38B. The core 596 has a notch 602 for a corresponding finger 592, the notch 602 allowing the finger to pass through but capture the adapter 540. The core 596 has a seat 604 for receiving the adapter 540 and the taper 606 to help guide the adapter during insertion. The core has an open-ended slot 608 with a taper 610. The notches and tapers guide and capture four contacts 544 having a taper 546, the taper 546 being located on the circumference of each cable contact 544. Fig. 19 shows the tab members 540 with each tab 544 captured in a corresponding slot 608 and the fingers 592 compressed, thereby capturing the tab members 540. Rim 594 forms a bearing means against the inner surface of sleeve 586. On the other hand, fig. 20 shows the released mechanism 584 with the fingers 592 deployed and the joint member 540 disengaged from the fingers. Mechanism 584 extends partially out of sleeve 586.
Having thus described a limited number of embodiments in connection with the principles of the present invention, it should now be apparent to those skilled in the art that numerous other embodiments and modifications of the invention are contemplated as falling within the scope of the invention as defined by the appended claims. For example, in the first embodiment disclosed herein, the cables are engaged by engagement between the cable lug 40 and the door 260. In alternative embodiments, instead of a tab, a recess may be provided in the cable, and instead of a slot or slit in the door, a protrusion may be employed for engagement with the recess. Further, the respective linkage and slider mechanisms may be interchanged between the various embodiments described herein.