US20080200758A1 - Endo-surgical Device and Method - Google Patents

Abstract

What is provided is an endo-surgical tool that includes imaging optics therein, the various components of which, including its tools, electronics and visualization components, can be used in the sterile surgical field. In one particular embodiment of the invention, the cannula portion of the tool is adapted to a particular type of endo-surgical procedure, while the handle, which includes at least a portion of the imaging circuitry for the device, can be used with a plurality of differently adapted cannulas.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• The present application claims priority from the following co-pending provisional patent applications:
• U.S. Patent Application Ser. No. 60/889,064, filed on Feb. 9, 2007, entitled METHOD AND APPARATUS FOR THE TREATMENT OF CARPAL TUNNEL SYNDROME;
  U.S. Patent Application Ser. No. 60/969,484, filed on Aug. 31, 2007, entitled CANNULA APPARATUS AND METHODS FOR USE;
  U.S. Patent Application Ser. No. 60/981,656, filed on Oct. 22, 2007, entitled ENDO-SURGICAL DEVICE AND METHOD;
  U.S. Patent Application Ser. No. 60/983,436, filed on Oct. 29, 2007, entitled ENDO-SURGICAL DEVICE AND METHOD; and
  U.S. Patent Application Ser. No. 60/992,930, filed on Dec. 6, 2007, entitled CANNULA APPARATUS AND METHODS OF USE. The above-listed applications are being incorporated herein, by reference, in their entireties.
FIELD OF THE INVENTION
• The invention relates to an endo-surgical device of the type including components such as tools, electronics and visualization components, and more particularly, to endo-surgical instruments for use in a system and method for minimally invasive endo-surgery.
BACKGROUND OF THE INVENTION
• Systems and devices useful for performing endo-surgery are known. A number of devices have been developed for use in minimally invasive surgical procedures, including orthopedic and podiatric soft tissue surgeries such as nerve and tendon release procedures. In particular, certain devices have been developed for performing “carpal tunnel” surgery to relieve the symptoms of “carpal tunnel syndrome”, in which the flexor retinaculum or “transverse carpal ligament” (TCL) is severed.
• Carpal tunnel syndrome refers to numerous clinical signs and symptoms resulting from pressure on the median nerve inside the carpal tunnel. Splints that immobilize the wrist in a neutral position are the most commonly used nonsurgical treatment for carpal tunnel syndrome because an unbent wrist maximizes the size of the carpal tunnel, which reduces pressure on the median nerve. Physical therapy and special hand exercises are also used to relieve mild to moderate symptoms of carpal tunnel syndrome. However, when the symptoms persist or become intolerable, surgical decompression of the nerve by release of the transverse carpal ligament, or flexor retinaculum, is performed.
• In early techniques, open carpal tunnel release surgery (OCTR) was performed to relieve carpal tunnel syndrome.
• OCTR is typically performed under local anesthesia, where a longitudinal incision is made in the base of the palm and sometimes extending into the wrist. This incision opens the skin, subcutaneous fat, palmar fascia and palmaris brevis muscle to expose the transverse carpal ligament, which is cut with a surgical blade. The cut ligament springs open and immediately provides more space for the median nerve to pass through the carpal tunnel. The incision is then closed with sutures.
• Although OCTR is currently the most commonly performed surgical carpal tunnel release procedure, it can lead to postoperative pain and morbidity lasting up to six months.
• Recent advances involve endoscopic carpal tunnel release surgery (ECTR), which is performed as a single-portal technique or a double-portal technique. For a single-portal technique, one incision is made either in the palm or in the forearm proximal to the wrist. For a double-portal technique, two incisions are made, one in the palm and one in the forearm proximal to the wrist.
• In 1987, the first reports of endoscope use in carpal tunnel release surgery were provided by Okutsu, a Japanese orthopedist. In Okutsu's technique, an incision is made 3 cm proximal to the distal wrist crease. Then, a clear plastic cannula is inserted into the carpal tunnel with an endoscope inside; under direct visualization, the transverse carpal ligament (TCL) is divided distally to proximally, with a hook knife.
• The next development occurred in the early 1990's with John Agee and Francis King, who created a single-portal endoscopic carpal tunnel release system having a probe with a trigger-activated mechanism for engaging a blade to cut the TCL. The Agee technique involves activating the trigger mechanism to engage the blade and elevating it perpendicularly above the upper surface of the probe. The instrument is then withdrawn, and under direct visualization, the TCL is divided in a distal to proximal direction. The Agee systems and techniques are disclosed in Agee, et al. U.S. Pat. No. 4,962,770; U.S. Pat. No. 4,963,147; U.S. Pat. No. 5,089,000; U.S. Pat. No. 5,306,284; and U.S. Pat. No. 5,613,976.
• Jay Menon created another single-portal technique involving a cannula with a D-shaped cross-section and an obturator. In Menon's technique, dilators are inserted through the antebrachial fascia into the carpal tunnel. Then, a cannula is passed under the TCL and a forward knife is used to cut the ligament proximally to distally while visualizing the TCL with an endoscope immediately following the knife.
• Ather Mirza created yet another single-portal technique involving a cannula, a scope mounted cutting blade and a tapered obturator. The Mirza technique involves inserting an elongate insertion member through the cannula and introducing the combined cannula and insertion member under the TCL. Then, after advancing the obturator beneath the TCL, the scope mounted cutting blade is inserted through the cannula to operatively engage the tissue. Mirza's systems and techniques are disclosed in Mirza U.S. Pat. No. 5,366,465; U.S. Pat. No. 5,578,051; U.S. Pat. No. 5,968,061; and U.S. Pat. No. 7,041,115.
• The first reports of double-portal ECTR were provided by James Chow in 1989, who developed a slotted cannula and obturator, synovial elevator, probes, and a series of knives for use in his technique. The Chow system is disclosed in U.S. Pat. No. 5,029,573. Then, in 1992, Michael Brown introduced an improved double-portal technique, where a slotted cannula is inserted in the carpal tunnel under the TCL and a surgeon's dominant hand is used to cut the ligament distally to proximally. The Brown system is disclosed in U.S. Pat. No. 5,323,765.
• The ECTR procedures described above significantly reduced the postoperative pain, morbidity and recovery time associated with OCTR procedures.
• However, there is a continuing need to improve ECTR and provide simple, workable systems and techniques that better protect the nerves and other portions of the hand during surgery. What is further needed is an improved, less cumbersome endo-surgical system that can be adapted for use with many other types of delicate endo-surgery, and not just for ECTR.
• Certain prior art systems have been developed wherein endoscopic images of the surgical procedure are obtained and displayed in monitors outside of the sterile surgical field to aid the surgeon during the procedure. Such prior art systems, by displaying obtained images on a monitor that is remote from the surgical field, require the surgeon to direct his gaze away from the surgical procedure. This leads to constant readjustments of focus by the surgeon's eyes as the alternates his gaze between the monitor and the patient, and also generates a distraction from the surgical activity itself.
• Furthermore, certain prior-art systems require that an optical scope with a video camera attached be inserted through the handle and/or the surgical cannula. The scope is, in turn, connected by a fiber optic cable to a light source and the video camera via a multi-wire cable to a monitor. Since both monitor and light source are located remotely from the immediate surgical field, these long cable connections tend to make the handle or holder relatively heavy and cumbersome, and thus, potentially limiting the surgeon during the performance of a fine, delicate surgery. The weight added by these cables further limits the number of patients that the surgeon can treat before becoming fatigued.
• What is needed is a system for endo-surgery wherein the imaging electronics and display can be located within the sterile surgical field. Such a system will not generate distractions from the surgical procedure. What is additionally needed is a system that, when held, does not encumber the surgeon's ability to perform delicate surgery or burden the surgeon with unnecessary weight.
SUMMARY OF THE INVENTION
• It is accordingly an object of the invention to provide an endo-surgical device, system and method that overcomes the above-mentioned disadvantages of the heretofore-known devices, systems and methods of this general type.
• What is provided is a lightweight endo-surgical tool that includes imaging optics therein and that is capable of transferring images to a display. In one particular embodiment of the invention, the cannula portion of the tool is adapted to a particular type of endo-surgical procedure, while the handle, which includes at least a portion of the imaging circuitry for the device, can be used with a plurality of cannulas adapted to perform different endo-surgical procedures.
• Other features which are considered as characteristic for the invention are set forth in the appended claims.
• Although the invention is illustrated and described herein as embodied in a particular type of endo-surgical device and method, it is nevertheless not intended to be limited to the details shown, since various modifications and structural changes may be made therein without departing from the spirit of the invention and within the scope and range of equivalents of the claims.
• The construction of the invention, however, together with additional objects and advantages thereof will be best understood from the following description of the specific embodiment when read in connection with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
• Like reference numerals refer to like items throughout the drawings.
• FIG. 1 is a perspective view of an endo-surgical system in accordance with one particular embodiment of the instant invention.
• FIG. 2 is an exploded view of a portion of the endo-surgical system ofFIG. 1.
• FIG. 3A is a perspective view of an endo-surgical system in accordance with another particular embodiment of the instant invention.
• FIG. 3B is a perspective view of an endo-surgical system in accordance with a further particular embodiment of the instant invention.
• FIG. 4A is a perspective view of another embodiment of an endo-surgical system in accordance with the present invention, including an exploded view of an endo-surgical device useful in that system.
• FIG. 4B is a perspective view of an endo-surgical system in accordance with another particular embodiment of the instant invention.
• FIG. 4C is a perspective cross-sectional view of an endo-surgical system in accordance with another particular embodiment of the instant invention.
• FIG. 4D is a perspective view of an endo-surgical system in accordance with another particular embodiment of the instant invention.
• FIG. 5A shows the typical anatomy of a portion of a hand.
• FIG. 5B shows a prior art cannula and the anatomy of the portion of the hand.
• FIG. 5C shows a cannula with a curved prow in accordance with one particular embodiment of the subject invention and the anatomy of the portion of the hand.
• FIG. 6 shows a perspective drawing of a cannula with a prow shaped geometry at the distal end in accordance with another preferred embodiment of the present invention.
• FIG. 7A is a side, partial cross-sectional view of an endo-surgical device with the blade at rest, in accordance with one particular embodiment of the present invention.
• FIG. 7B is a side view of an endo-surgical device with the blade deployed, in accordance with one particular embodiment of the present invention.
• FIGS. 8A and 8B are partial perspective views of the cannula shown inFIGS. 7A and 7B.
• FIG. 8C is a partial, cross-sectional view taken from the side of the cannula shown inFIGS. 7A and 7B.
• FIG. 8D is a partial, cross-sectional view taken from the side of a cannula for an endo-surgical device with the blade deployed, in accordance with one particular embodiment of the present invention
• FIGS. 9A-9C show straight, curved and angled cannulas with prow shaped distal end geometry that are particular embodiments useful with the present invention.
• FIG. 10A is a partial, cross-sectional view, taken from the side of the cannula showing in dotted line the arcuate deployment of the blade in accordance with one particular embodiment of the present invention.
• FIG. 10B is a partial, cross-sectional view, taken from the side of a cannula, in accordance with one particular embodiment of the present invention, having its blade at rest.
• FIG. 10C is a partial, cross-sectional view, taken from the side of a cannula, in accordance with one particular embodiment of the present invention, having its blade deployed.
• FIG. 11A is a cross-sectional view, taken from the side, of a fixed prow, single-action cannula, in accordance with one particular embodiment of the present invention, having its blade at rest.
• FIG. 11B is a side view of a fixed prow, single-action cannula ofFIG. 11A, having its blade deployed.
• FIG. 12A is a cross-sectional view, taken from the side, of a drop-prow, single-action cannula, in accordance with one particular embodiment of the present invention.
• FIG. 12B is a side view of the single action cannula ofFIG. 12A, having its prow dropped.
• FIG. 13A is a cross-sectional view, taken from the side, of a double-action cannula, in accordance with one particular embodiment of the present invention.
• FIG. 13B is a side view of the double-action cannula ofFIG. 13A, having its prow dropped and its blade deployed.
• FIG. 14 is a cross-sectional view of the prow of a cannula in accordance with one particular embodiment of the present invention, performing the transverse carpal ligament release procedure.
• FIG. 15 is a cross-sectional view of prior art device performing a transverse carpal ligament release procedure.
• FIG. 16 is a cross-sectional view of prior art device performing a transverse carpal ligament release procedure.
• FIGS. 17A-17C show a technique for performing an ECTR using a cannula according to an embodiment of the subject invention, whereinFIG. 17A shows insertion,FIG. 17B shows retraction, andFIG. 17C shows ligament division.
• FIGS. 18A-18B show one particular embodiment of the subject cannula in connection with an ECTR system.
• FIGS. 19A-19C show a technique for performing an ECTR using a cannula according to another embodiment of the subject invention, whereinFIG. 19A shows insertion,FIG. 19B shows deployment, andFIG. 19C shows ligament division.
• FIGS. 20A-20B show one embodiment of a cannula including a slot and pin release mechanism of the curved prow, for use with the system ofFIGS. 19A-19C.
• FIGS. 21A-21B show another particular embodiment of a cannula including a tool for use in accordance with the present invention.
• FIGS. 22A-22B show another particular embodiment of an endo-surgical device including a tool for use in accordance with the present invention.
• FIGS. 23A-23B show another particular embodiment of an endo-surgical device including a tool for use in accordance with the present invention.
• FIG. 23C shows one particular use of the tool ofFIGS. 23A and 23B.
• FIG. 24 show the use of another particular endo-surgical instrument in accordance with another embodiment of the present invention.
• FIGS. 25-34 show particular embodiments of an inventive spreader device and assembly that can be used in connection with different embodiments of the present invention.
• FIGS. 35A-35C show another particular embodiment of an endo-surgical device including a tool for use in accordance with the present invention.
• FIGS. 36A-36C show another particular embodiment of an endo-surgical device including a tool for use in accordance with the present invention.
• FIG. 37 is a cross-sectional view of a handle including an electronics module, in accordance with one particular embodiment of the present invention.
• FIG. 38 is a side view of an electronics module, in accordance with one particular embodiment of the present invention.
• FIG. 39A is a perspective view of an electronics module, in accordance with a particular embodiment of the present invention.
• FIG. 39B is an exploded view of the electronics module ofFIG. 39A.
• FIGS. 40A-40D are block diagrams showing various embodiments of systems useful with the present invention for providing image data between the end of a cannula and a display.
• FIG. 41A is a partial, isometric view of a cannula of one particular embodiment of the present invention.
• FIG. 41B is a plan view taken from the top of a cannula in accordance with one particular embodiment of the present invention.
• FIG. 41C is a plan view taken from a side of the cannula ofFIG. 41B.
• FIGS. 42A,42B and42C show, respectively, a top, front and cross-sectional view of a first prior art.
• FIGS. 43A,43B and43C show, respectively, a top, front and cross-sectional view of a second prior art.
• FIGS. 44A,44B and44C show, respectively, a top, front and cross-sectional view of a third prior art.
• FIGS. 45A,45B and45C show, respectively, a top, front and cross-sectional view of a particular embodiment of the current invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring now toFIGS. 1-4D, there is shown asurgical system10 for minimally invasive, minimally encumbered endo-surgery in accordance with particular embodiments of the instant invention. As will be discussed more particularly below, the endo-surgical system10 includes acannula20, a handle orhandpiece30, an electronics module (EM)40 and adisplay50.
• Thecannula20 ofsystem10 includes a straight, angled or curved, rigid shaft that is designed for a specific surgical, therapeutic and/or diagnostic purpose. In some embodiments, thecannula20 can be disposable and, in others, it may be sterilized for reuse. In the present system, the cannulas are designed to be procedure-specific (i.e., each is individually designed for a specific visualization and/or surgical procedure). For example, in one particular embodiment for the endoscopic carpal tunnel release procedure, acannula20 is provided that has a curved (or angled) distal end that protrudes from its main body. This curved distal end facilitates tactile identification of the distal edge of the transverse carpal ligament (TCL) and is capable of displacing a fat pad located distally of the TCL to allow clear visualization of the distal edge of the TCL before dividing the TCL.
• In thesystem10, a desiredcannula20 can be attached to and/or detached from a sterile or sterilizable light-weight handle30. As with thecannula20, thehandle30 can be disposable or, if desired, can be capable of being re-sterilized for re-use. The ability to detach thecannula20 from thehandle30 also permitsdifferent cannulas20, (i.e., each adapted for different surgical procedure) to be used on a single,universal handle30. When attached, thecannula20 is mechanically coupled to thehandle30.
• In order to permit visualization of the surgical procedure at the surgical site, thecannula20 includes at least a portion of an optical or electronic imaging device, as defined further below. In one preferred embodiment, another portion of the imaging device is incorporated into anelectronics module40. Theelectronics module40 is located within thehandle30. For example, in one particular embodiment, the handle may be hollow and adapted to receive theelectronics module40. Because theelectronics module40 is accepted into the sterile/sterlizable handle30, theelectronics module40 may be non-sterile and reusable.
• Upon insertion of theelectronics module40 into thehandle30, the handle is sealed with thesterile cap32, isolating thenon-sterile electronics module40 from the sterile surgical field. Once thesystem10 is assembled (i.e., theelectronics module40 is inserted into thehandle30, sealed with thecap32, and thecannula20 attached at the distal end), theelectronics module40 becomes connected to thecannula20.
• The images obtained by the imaging device ofsystem10 are processed and displayed on adisplay50, which will be discussed more particularly below. Thedisplay50 may be attached to thehandle30, or detached, but located within or close to the sterile surgical field. Additionally thedisplay50 can be tethered to theelectronics module40 to receive image information obtained by the imaging device in the cannula. Alternately, thedisplay50 can receive image information wirelessly from theelectronics module40. Images obtained by the imaging device in the cannula and processed by the electronics module can be displayed on thedisplay50, so that the surgeon can visualize an image of the surgical procedure substantially in-line with, and without having to significantly shift his/her gaze from, the surgical field.
• As discussed above, thehandle30 can accept a variety ofdifferent cannulas20 used for different surgical procedures, while being serviced by essentially thesame electronics module40 anddisplay50.
• In an alternate embodiment (FIG. 4D), thecannula20 and thehandle30 are built into one single disposable unit and theelectronics module EM40 is located outside of the handle and connected to it by means of a cable connection. Furthermore, theelectronics module40 anddisplay50 may be linked together and sealed within ansterile enclosure60 suitable for location within the sterile surgical field. Alternatively, the display, with or without the electronics module may be sterilizable.
• Each of the parts of thesystem10 will be described in more detail, herebelow.
The Cannula:A. Cannulas for Endo-Surgical Procedures.
• As discussed above, the present invention relates to a surgical system and instruments for minimally invasive endo-surgery, which can be used within the sterile surgical field. This field encompasses orthopedic and podiatric soft tissue surgeries such as nerve and tendon release procedures. Also, the field of endo-surgery, and for use of the present inventive device, includes plastic surgery procedures such as endoscopic face lifts and general or vascular surgery procedures, such as saphenous vein harvesting as well as others. As such, the cannula of the present invention can be adapted to the specific endo-surgical procedure it is designed to perform, so as to facilitate initial soft tissue separation or dissection by imparting to it a specific geometry at its shaft and at its distal end. Each cannula useful with the instant invention may also be designed to perform surgical manipulation of the tissues and other therapeutic purposes using procedure-specific tools.
• For example, as shown inFIGS. 9A-9C, thecannula20 is rigid but can have a straight, angled or curved shaft; it is introduced into the human body through either a small incision or through percutaneous means to allow visualization and/or diagnosis and/or surgical and/or therapeutic manipulation of the tissues.
• Visualization can be provided by an “imaging device”, which can include an image sensor (CMOS, CCD, FOVEON, or similar device) and lens, at least a portion of which is located close to the distal end of the cannula. Additionally, a transparent housing may encapsulate the lens and sensor or the lens can be molded into the transparent housing. Alternately, the imaging device can be an optical endoscope originating in the handle and passing through a lumen in the cannula.
• The imaging device can also include illumination, which may be provided by either LED's located close to or at the distal end of the cannula (preferred embodiment), or by fiberoptic or light pipe transmission from a light source in the handle. If desired, the fiberoptic may be integral to an endoscope or the cannula, itself, may serve as the light pipe.
• The cannula may also house and allow the deployment of one or more surgical tools or instruments such as a knife, scissor, tissue spreader or other device to allow the surgeon to perform manipulation of the tissues or other diagnostic or therapeutic procedures.
• In one embodiment disclosed below, the entire procedure can be performed with a single cannula without the need for other instruments. In an alternate embodiment a separate surgical instrument may be used in conjunction with a cannula that is intended solely for visualization (i.e., without tools that allow separation, dissection or surgical manipulation of tissues).
• Further, in a preferred embodiment discussed herein, the cannula is designed to be detachably connected to the handle. Upon attachment, the cannula becomes mechanically coupled to the handle and optically or electrically connected to the electronics module contained within the handle.
• As such, a tool kit can be provided that includes a single handle, electronic module and display, but also a plurality of different cannulas adapted for different surgical, therapeutic or diagnostic procedures.
• The cannula may be reusable or disposable. If disposable, the cannula comes sterile within a pack and is intended to be used only once and discarded.
• The cannula may include one or more actionable triggers, levers or buttons to operate the tools that may have been provided. Alternatively, some or all triggers, levers or buttons may be included in the handle.
• Additionally, the cannula and/or the handle can be provided with one or more mechanisms, such as levels, bubbles or transverse wings or pegs, to aid in indicating rotational position of the cannula.
B. Exemplary Cannulas Adapted Specifically for an Endoscopic Carpal Tunnel Release (ECTR) Procedure.
• In one particular example of the system of the present invention, the system will be described in connection with a cannula designed specifically to perform an endoscopic carpal tunnel release surgical procedure. The ECTR cannula of the present invention is intended to be used as a single instrument expressly designed to perform all of the following functions: (i) separate the synovium and/or other tissue from the TCL; (ii) inhibit tendons, nerves or other tissue from invading the surgical space defined by the cannula as the cannula is advanced; (iii) encourage the cannula to self-center within the carpal tunnel as the cannula is advanced; (iv) inhibit the rotation of the cannula within the carpal tunnel; (v) provide tactile feedback to the surgeon at the moment when the carpal tunnel has been fully traversed and the distal edge of the TCL has been reached; (vi) displace the fat pad found beyond the distal edge of the TCL to permit good visualization of the location where division of the TCL should begin, and (vii) execute the division of the TCL, without damaging other tissue. Traditional endoscopic carpal tunnel release methods use a straight cannula. However, a straight cannula has certain limitations with respect to the anatomy of the hand being operated.FIGS. 5A-5C show a comparison of the effects of using a curved cannula, in accordance with one particular embodiment of the invention, and with a straight cannula, as per the prior art. In particular, referring toFIG. 5A, the typical anatomy of a hand in the region of the transversecarpal ligament110 is shown to include a synovial orfat pad112 within which important arteries andnerves113 can be found. Theligament110 tends to be airfoil shaped. When a prior art straight cannula100 (i.e., the tip being in the same plane as the shaft) is inserted into the patient's hand between the tendon/nerve111 and theligament110, thecannula100 may travel under thefat pad112. Thestraight cannula100 does not allow for good visualization of the distal edge of theligament110 because of the interposition of thefat pad112. This may cause an incision of thefat pad112 when theknife102 is deployed, as shown inFIG. 5B possibly severing the arteries and/or nerves within.
• In contrast, as shown inFIG. 5C, acannula100′ with a curved-tip104 according to embodiments of the subject invention is capable of displacingfat pad112. By displacingfat pad112, acannula100′ incorporating a curved-tip104 can provide a clear view of the edge of theligament110. An angled-tip can be used in place of the curved-tip104. This angled or curved tip will hereafter be referred to as the “prow”. Note that, as used herein, references in the specification and the claims to the “curved-tip” and “angled-tip”, or “curved end” and “angled end”, of the cannula are interchangeable and are not intended to be exclusive of any embodiments that might fall under one term or the other. Rather, as will be readily understood by the skilled artisan, whether the distal end of the cannula protrudes upward as a result of a relatively abrupt angle or a more gradual curve, it will facilitate displacement of the fat pad, and is thus within the scope of the subject invention.
• Additionally, certain embodiments of the subject invention will be described as having a curved tip, which, for purposes of the present application means that the distal tip of the prow is above the top surface of the cannula (i.e., in a different plane that lies above the plane of the top surface of the cannula's shaft) when the prow is in its resting position. In addition, the configuration of the prow facilitates identification of the far edge of the TCL by providing tactile feedback that the TCL has been crossed, a characteristic not seen in the prior art.
• More particularly, referring now toFIG. 6 of the instant application, there is shown one particular preferred embodiment of a cannula including a flared prow, not unlike that of an ocean going ship with a high freeboard. As can be seen fromFIG. 6, the upper edges of theprow180 of thecannula160 gradually diverge, reaching a maximum width at point “A”, and then, gradually converge towards thedistal end180b. The maximum width of the prow180 at the point “A” is greater than the width of the shaft of thecannula160. The width of the prow is also greater than the height of the prow at point “A”. Additionally, the flaredprow180 of the cannula is open at the top, between a portion of the upper edges, such that the walls and bottom of said prow define a bowl or cavity, therebetween.
• As the cannula is advanced, it is this flared prow180 that cleanly and clearly separates synovium and/or other tissue from the TCL and inhibits the invasion of nerves, tendons and other tissues into the surgical space defined by the cannula. As can be seen from the drawings, and more particularly, fromFIG. 6, the cross-section of the flaredprow180 is shaped like an inverted bell and, being relatively wide, occupies more space within the carpal tunnel than prior art devices. Since the greater width inhibits the lateral displacement of the prow in the confined space of the carpal tunnel, there is a greater assurance that the center line of thecannula160 will tend to coincide with the center line of the carpal tunnel, minimizing the risk of a displacement that could lead to injuring the ulnar nerve and/or artery which lie on the hamate side of the tunnel. Upon reaching the distal edge of the TCL, the flaredprow180 also displaces the fat pad exposing the distal edge of the TCL to visualization by the surgeon.
• Additionally, as shown inFIG. 6, the upper edges of thecannula160 become more flared asdistal end180bis approached. The top surface of the prow180 curves upward, whereas the bottom surface of the prow180 projects downward. Seen on a longitudinal section, the top surface of the prow180 is curved or angled upwards so that it mostly lies above the projected upper surface of the shaft of the cannula while the lower surface of the prow projects downwards so that its bottom lies below the bottom surface of the shaft, as shown at point “B”. This geometry, in combination with the geometry described in the previous section, makes the prow bulbous, not unlike a lollipop. In other words the short, distal-most portion of the cannula has a greater cross-sectional area than the longer, more proximal part, which has a smaller cross-section. Since carpal tunnel syndrome is a form of compartment syndrome, or disorder caused by increased tissue pressure, this design feature provides the surgeon with a propioceptive or tactile feedback effect that informs him that he has traversed through the area of increased pressure or disease condition, and helps the surgeon determine the proper depth of insertion of the instrument before initiating the division of the TCL.FIGS. 41A-41C show one particular embodiment of a cannula of the present invention having a geometry suitable for creating the above-described “lollipop” effect during use. Note that in the device in accordance with the present invention shown inFIG. 45, contrary to the prior art cannulas shown inFIGS. 42-44, the short, distal-most portion of the cannula has a greater cross-sectional area than the longer, more proximal part, which has a smaller cross-section.
• The above-mentioned feature of the invention is useful in either distal to proximal surgical divisions, as well as proximal to distal surgical divisions.
• Further, in particular embodiments of the invention, as shown more particularly inFIGS. 7A,7B,9A and9C, theupper surface181 of theprow180 of the cannula has an increased flat contact area, which, optionally, includes theribs182, extending between the prow180 and the TCL of the patient. Theribs182, which are closely spaced in the present preferred embodiment, also prevent the resting (i.e., not yet deployed) knife from unintentionally cutting tissue that may project into the cavity. This flat or ribbed surface also inhibits the rotation of the cannula around its longitudinal axis in such a way that the knife, when later deployed, will do so on a plane perpendicular to the surface of the TCL to be divided. The flat contact area also prevents the prow180 from snagging with the multiple fibers of the TCL upon insertion and advancement by the surgeon.
• Referring now toFIGS. 7A-13B, there are shown a plurality of preferred embodiments of an endo-surgical device for use in ECTR wherein the prow is curved or angled relative to the shaft of the cannula (i.e., the tip of the prow being above the plane defined by the upper surface of the cannula shaft) and incorporates a flared prow. As described herein, each cannula can be specifically adapted to a particular application, which, in the present embodiment, is ECTR.
• More particularly,FIGS. 7A and 7B are side views of an endo-surgical device155 in accordance with one particular embodiment of the present invention. Thedevice155 includes ahandle170 with adetachable cannula160 connected thereto. Thecannula160 is a curved-tip cannula (i.e., thedistal surface163 being above the upper surface of the shaft169), wherein theblade165 is deployed by pulling amechanical actuator168 which causes the knife to project above the cavity. Note that thecannula160 can include an imaging assembly (162 ofFIGS. 7A-7B) in communication with an EM module, all or portions of which may be located in thehandle170, as discussed in connection withFIGS. 1 and 2, above, or can include an optical endoscope (167 ofFIG. 4B or8D), of a type known in the art.
• In the instant example, theprow180 of thecannula160 is fixed (i.e., does not drop) and theactuator168 is connected by a linkage and rod (172 ofFIGS. 8B-8D) to the proximal end of theblade165. Theblade165 is fixed at apivot point166 to the distal end of thecannula160. Thus, theblade165 can be deployed in an arcuate (i.e. curvilinear) path from the cavity in the prow of the cannula by moving theactuator168 to push the proximal end of theblade165 with the rod, as shown inFIG. 7B. By reversing the direction of theactuation mechanism168, and resultantly pulling therod172, theblade165 is retracted in a reverse arcuate trajectory to its resting position in the prow of thecannula160, as shown inFIG. 7A. It can be seen by one skilled in the art that such a trajectory will reduce the incidence of loose tissue which may be lying above the prow, from becoming pinched during retraction of the blade.
• Referring more particularly toFIGS. 8A-8C, enclosed within the distal portion of the shaft of thecannula160, close to the proximal end of the flared prow is, at least, part of animaging device162. In the present preferred embodiment, theimaging device162 preferably includes an image sensor184 (such as a CMOS, CCD or FOVEON) fitted with alens162aor, alternatively, an optical scope (167 ofFIG. 8D). If desired, theimage sensor184 andlens162amay be encapsulated within a separate transparent housing. Also, close to location of thelens162ais alight source186 such as one or more LEDs or, alternatively, the output end of a light tunnel or light transmitting fibers channeling light from a source outside of the cannula. Additionally, if desired, the flared prow of the cannula may be made of transparent material such as acrylic and may be fixed or movable.
• Referring now toFIG. 9A, there is shown a perspective view of the fixed prow detachable cannula of one particular embodiment of the present invention, as described above in connection withFIGS. 7A-8C. In this embodiment, the shaft of thecannula160 is straight.Cannula160 can be detachably connected to a handle, such as thehandle170 ofFIGS. 7A and 7B, via theconnector161. Theconnector161 provides both a mechanical connection with the actuation mechanism of the device, as well as an electrical connection with the electronics in thehandle170. For example, theconnector161 includes female connections that mate with pins on the electrical module (410 ofFIGS. 39A-39B), if used. Alternately, as shown inFIGS. 4B and 8D, anendoscope167 can be passed through theconnector161. Note that, theendoscope167 includes a connector that engages the EM module, such that images obtained by theendoscope167 are provided to electronics on theEM40.
• FIGS. 9B and 9C show alternate embodiments of a fixed prow cannula including a deployable knife, in accordance with the present invention. More particularly, thecannula160′ includes a flared fixed prow located at the distal end of thecannula160′, the shaft of which is curvilinear. This curvilinear disposition of the shaft of thecannula160′ permits the prow to be elevated even more than in the embodiment ofFIG. 9A, which is useful in pushing the fat pad out of the way during ECTR.
• Similarly, the shaft ofcannula160″ ofFIG. 9C includes an angle bend atpoint160″a.
• This curvilinear and angled shaft permits easy access to surgical sites that may be less accessible when using a straight shaft cannula (i.e. access from the palm of the hand towards the wrist in the case of ECTR).
• Referring now toFIGS. 10A-10C, there is shown in greater detail an illustration of the deployment of the blade from the prow portion of thecannula160 ofFIG. 9A. More particularly,FIG. 10B shows thecannula160 having theblade165 at rest. To deploy theblade165, an actuation mechanism at the handle is deployed, which in the present embodiment, pushes therod172, resultantly moving theblade165 along an arcuate path defined by thepin166 and theblade slot169.FIG. 10A illustrates (in dotted line) the arcuate path followed by theblade165 during deployment. Additionally,FIG. 10C shows the fully deployedblade165, having thepin166 resting at the deployed end of theblade slot169.
• Referring now toFIGS. 11A,11B,12A,12B,13A and13B, there are shown three particular embodiments of a cannula that can be used in connection with the system of the present invention to perform ECTR. More particularly, the cannula shown inFIGS. 11A and 11B is a fixed prow cannula with amovable blade165, as discussed above in connection withFIGS. 7A-10C. In thecannula160 ofFIGS. 11A and 11B, the prow is fixedly attached to the shaft of thecannula160 and does not move separately therefrom, while theblade165 can be selectively actuated, as described above.
• In contrast to thecannula160 ofFIGS. 11A and 11B, thecannula190 shown inFIGS. 12A and 12B has amovable prow192 and a fixedblade195. In thecannula190 ofFIGS. 12A and 12B, it is theblade195 that is fixedly attached to the shaft of thecannula160 and does not move separately therefrom, while the prow192 can be actuated selectively to drop, thereby exposing the TCL to theblade195.
• Both of the above-described cannulas are “single-action” cannulas, because only a single action is performed to deploy the blade (i.e., the prow is dropped or the blade is raised). Thecannula200 shown inFIGS. 13A and 13B is a “double-action” cannula, wherein the blade is exposed by both dropping the prow202 and raising theblade205. More particularly, in one particular embodiment, an actuation mechanism is incorporated into thecannula200, that communicates with an actuation mechanism or lever on the handle of the device to simultaneously drop the prow202 and deploy theblade205, pivoting it along an arcuate path defined by apivot pin207 and theblade slot206.
• In operation, the purpose of theblade165,195,205 stored within the prow of thecannula160,190,200 is to divide the TCL. During insertion and advancement of thecannula160,190,200, the flared prow and, if included, theribs182 shield theblade165,195,205 from any contact with tissue. When the prow reaches a desired position at the distal edge of the TCL, the surgeon can deploy theblade165,195,205 to initiate the division of the TCL. If the flared prow is movable, as in the embodiment ofFIGS. 12A-12B, the deployment of theblade195 is accomplished by a mechanism that drops the flared prow downwards while theblade195 remains fixed. If the flared prow is fixed, the knife can be deployed by a mechanism that projects it upwards, following an arcuate path, until it protrudes above the upper edge of the flared prow, as described in connection withFIGS. 10A-10C and11A-11B. Alternatively, a mechanism can both drop the movable flared prow while, simultaneously, projecting the knife upwards along an arcuate path, as described in connection with the particular embodiment ofFIGS. 13A-13B.
• Note that, although one particular mechanism for dropping the prow/raising the blade is described herein, this is not meant to be limiting, as other actuation mechanisms can be employed while still being within the spirit of the present invention. For example, the blade and/or prow of cannula of the present invention can be deployed using an electronic solution, such as electromagnets and/or solenoids and/or other mechanisms, electrically actuated by a button on the handle of the device. Additionally, the cannula may include one or more actionable triggers, levers or buttons to operate the movable flared prow, movable blade or both. Alternatively, some or all triggers, levers or buttons may be included in the handle.
• Referring now toFIG. 14, there is shown a cross-sectional view of theprow180 of acannula170, in accordance with one particular embodiment of the present invention, performing the carpal tunnel ligament release procedure. As shown inFIG. 14, and in contrast to the prior art ofFIGS. 15 and 16, the flaredprow180 of the instant invention limits the displacement (FIG. 15) and rotation (FIG. 16) of the cannula, reducing the potential of the knife approaching the ulnar nerve and/or artery. Note that the flare of the prow180 collides with the hook of the hamate (H), which limits displacement of the cannula, while the flat and wide upper surface of prow is tight against the TCL, which inhibits rotation of the cannula.
• In connection with the present invention, the flared edge can be formed along the whole length of the cannula. Alternately, the flared edge can extend only through the prow, or even on a limited portion of the prow. Advantageously, this flared edge serves to create space between the TCL and the carpal bursa (or other tissues) by dissecting or separating tissue layers as it is advanced. Additionally, the flared edge can provide a greater field of view and, further, inhibit tendons and nerves from interfering with the surgical space created by the cannula. Further, in one particular embodiment of the present invention, the ribs provide a narrow protective slit to insure isolation of tissue from the blade, reducing the potential of injury as the cannula is advanced.
• If desired, the distal most portion of the cannula prow can incorporate a dissector tip embodied in a flared edge of the distal prow. In such an embodiment, the tip of the distal prow having the flared edge should be somewhat rounded and can serve to separate pre-existing tissue planes such as to create space between the ligament and the carpel bursa by dissecting as it is introduced and advanced. Accordingly, the flared edge can create its own space as the cannula is advanced.
• Note that, the above-described embodiments of cannulas are not meant to be limiting, as other cannula designs can be used for ECTR, while remaining within the spirit of the invention. For example,FIGS. 17A-17C illustrate another particular embodiment of a curved-tip cannula140 having a distal prow, in accordance with the present invention. As with the previously described embodiments, thecannula140 includes aknife125 and anoptical device130. Note that, in the particular embodiment shown, theoptical device130 is an endoscope in optical communication with theeyepiece144. Additionally, the curved-tip cannula140 can expose theknife125 and theoptical device130 along the length of the cannula140 (i.e., thecannula140 being a channel open at its top surface). In one embodiment, theknife125 andoptical device130 can be exposed along the top surface of thecannula140 from distal to proximal ends such that theknife125 andoptical device130 can be moved together along the longitudinal axis of the cannula after theknife125 is released. In another particular embodiment, thecannula140 can have a substantially “U” shaped cross-section such that theknife125 andoptical device130 can be pocketed within thecannula140. In an embodiment where the curved-tip cannula140 is independent from the knife/optical device assembly, theligament110 can be cut after separating theknife125 from thecannula140 by pulling the knife/optical device assembly proximally. In another embodiment, the cutting edge of theknife125 can be deployed using a deployment mechanism before using the knife to cut theligament110.
• Referring more particularly toFIG. 17A, in one particular embodiment of the invention, the curved-tip cannula140 conceals the knife's edge such that the knife edge is protected during insertion of thecannula140. In the particular embodiment shown inFIGS. 17A-17C, a unitary knife/optical device assembly132 is used. The knife/optical device assembly132 can incorporate anoptical device130 fixedly attached to aknife125 having a knife edge.
• Referring now toFIG. 17B, after insertion of thecannula140, the knife/optical device assembly132 can be retracted while thecannula140 remains in place. In one embodiment, theknife125 can have atip engagement nipple126 that can engage the distal end of thecannula140 for securing theknife125 within thecannula140. In an embodiment, theknife125 can be retracted from within thecannula140 by depressing a release mechanism (see, for example168 ofFIG. 7A) that disengages thetip engagement nipple126 from the distal end of thecannula140. In this embodiment, rotation between thecannula140 and the knife/optical device assembly132 can be limited by matching cross sections that inhibit rotation.
• Referring toFIG. 17C, theligament110 can then be divided as the knife/optical device125,130 is pulled proximally through theligament110. In one particular embodiment, thecannula140 can be kept in place by a securing means. In a specific embodiment, the securing means can be atack135 inserted through a patient's skin into a tack opening at the tip of thecannula140. Thetack135 can be inserted through the skin and the tack opening of thecannula140 once the distal prow of the cannula is in place permitting a view of the distal edge of theligament110 through theoptical device130. In other embodiments, the securing means can be non-percutaneous device, such as a strong magnet attracting the prow of the cannula through the patient's skin.
• Theoptical device130 ofFIGS. 17A-17C can be cylindrical in shape and can have a distal end cut at anangle131, as shown. In a specific embodiment, the distal end of theoptical device30 can be at an angle close to or equal to 45°. In another embodiment, the distal end of theoptical device130 can be at an angle close to or equal to 30°. In one particular embodiment, at least a portion of the curved-tip141 of thecannula140 can be formed of a clear material. For example, acrylic can be used to form at least a portion of the curved-tip cannula140.
• Referring toFIGS. 18A and 18B, the curved-tip cannula140 and knife/optical device assembly132 can incorporate aneyepiece144 or otherwise be connected to an electronics module (see, for example,FIG. 4B). In one embodiment, the curved-tip cannula140 can be part of a disposable blade assembly. As shown inFIG. 18B, thecannula140 can be independent from the knife/optical device assembly132. In use, a surgeon can insert thecannula140 with knife/optical device assembly132 into a patient's hand under endoscopic visualization and can then deploy the knife/optical device assembly132 to cut the ligament. Note that the presently described endo-surgical system ofFIGS. 18A-18B may or may not use an electronics module, as described elsewhere herein. This is not meant to be limiting, as the knife/optical device assembly132 of the instant embodiment can additionally be adapted to use an optical system and electronics module, as will be described more particularly in connection withFIGS. 1-4D, among others.
• Note that, the cannula of the present invention is not meant to be limited to that shown inFIGS. 18A and 18B. For example, if desired, the cannula and knife/optical device assembly can be combined into a single non-independent assembly. Additionally, if desired, the cannula need not be open along the top surface and need not expose the length of the knife and optical device. Rather, in such embodiments, the cannula will have a small opening at the tip, sufficient to permit cutting and, optionally, optical viewing when the knife is exposed.
• Referring now toFIGS. 19A-19C, there is shown one particular embodiment of a curved-tip cannula150 that covers or conceals the edge of theknife125 such that the knife edge can be protected during insertion of thecannula150. In this embodiment, the blade edge of theknife125 can be in a protected position during insertion of the cannula. As with the embodiment ofFIGS. 17A-17C, the knife/optical device assembly132′ can incorporate anoptical device130 fixedly attached to aknife125 having a knife edge.
• Referring toFIG. 19B, after insertion of thecannula150, theknife125 can be deployed. In the embodiment shown, theknife125 can be exposed by straightening thedistal prow150bof cannula150 (i.e., dropping the tip such that the plane of the tip approaches the plane of the top surface of the cannula prow).
• As shown more particularly inFIGS. 20A and 20B, live hinges, pins and/or traditional hinges can be used to facilitate activation of thedistal prow150b, and thus opening and closing of thedistal prow150b. Other embodiments are additionally possible. For example, one particular embodiment wherein the blade edge of theknife125 begins in a retracted position, the blade edge can be deployed into an extended position to cut theligament110 using a deployment mechanism. In the embodiment illustrated inFIGS. 20A and 20B, arelease mechanism160 can be used to straighten thedistal prow150bof the cannula. Therelease mechanism160 can incorporate atransverse pin154 andslot152, as shown inFIGS. 20A and 20B. In one particular preferred embodiment, theslot152 can be placed in thedistal prow150bat thetip151 of thecannula150.
• In another embodiment of the instant invention, theknife125 can be retracted proximally or distally a short distance, preferably less than 10 mm and, more preferably, less than 2-3 mm. By retracting theknife125, a transverse pin can be moved on a slot formed in thedistal prow150b. If desired, an engagement mechanism (not shown) can be incorporated on the cannula to engage the release mechanism. The engagement mechanism can be depressed to expose the knife125 (see, for example, theengagement mechanism168 ofFIG. 7B). For example, an engagement/actuation mechanism can be provided, depression of which moves thetransverse pin154 along theslot152.
• Referring toFIG. 19C, theligament110 can then be divided as thecannula150 and knife/optical device assembly132′ are pulled proximally as a unit through theligament110. It is possible that more than one pass of theblade125 will be required to sever the ligament.
• Referring more particularly toFIGS. 20A-20B, theslot152 can be formed at different angles and can also be shaped as an arc segment concentric to the center of rotation of the curved tip.FIGS. 20A and 20B illustrate only one possible embodiment for the slot and pin combination. As shown, thedistal prow150bcan be straightened by pushing the release mechanism. As the release mechanism is pushed, thepin154 can be moved up theslot152 in the cannula causing thedistal prow150bof the cannula to straighten. As the distal prow straightens out, it exposes the knife125 (FIG. 19B) to allow cutting of theligament110. From the foregoing, it is understood that other slot orientations are possible while still keeping with the spirit of the present invention
• As with the previous embodiment, thedistal prow150bof thecannula150 can be formed of clear material. In a specific embodiment, thedistal prow150bof thecannula150 can be formed of acrylic.
• Cannula with Spreader Device
• In the preferred embodiment of the invention, the endo-surgical system can be used with various surgical, diagnostic or therapeutic tools, and can incorporate one or more actuators. Examples of tools that can be utilized can include scissors, a blade, grasping claw, spreader, and pushing tool. Accordingly the subject cannula can be adapted to include and operate the various tools. Thus, actuators for operating the various tools can be integrated with the cannula and/or with the handle. Additionally, if an actuator is integrated on the cannula, the handle can have a cut-out near the attachment site to provide trigger/actuator space for different cannula attachments.
• More particularly, referring now toFIGS. 21A-24, there is shown aspreader device210 for creating or maintaining a soft tissue surgical cavity in endo-surgical procedures. For example, in contrast to the carpal tunnel cannulas shown inFIGS. 7-13, the spreader device shown inFIGS. 21A-24 is specially adapted for use in surgeries where it is necessary to create a relatively large temporary tissue cavity in order to access the specific anatomical structures that are to be surgically manipulated. These procedures include, but are not limited to, tendon sheath release surgeries such as triggerfinger release, Dequervain's release and posterior tibial tendon release. The spreader device ofFIGS. 21A-24 can also be used for connective tissue transection surgeries such as tennis elbow release, plantar fasciotomy and fasciotomies in general. Furthermore, the spreader device ofFIGS. 21A-24 is particularly adapted to perform nerve release operations such as cubital tunnel release, pronator tunnel release, Morton's neuroma release and tarsal tunnel release. Common to all these surgical procedures, the anatomical structure to be operated upon is covered by a substantial amount of subcutaneous tissue that must be displaced.
• As shown inFIGS. 21A-21B, the spreader device includes aspreader cannula212 component that is introduced into the body and an expansible mesh orscaffold component214 that is deployed through this cannula. This scaffold, after deployment, tents or supports adjacent tissue away from the anatomical structure of interest in order to allow its endoscopic visualization and surgical manipulation.
• In one particular embodiment of the present invention, as shown inFIGS. 22A and 22B, thespreader device210 is a separate unit and can matingly engage with the endo-surgical imaging cannula portion of a device similar to the one shown inFIGS. 1 to 4D. Thespreader cannula212 would be introduced into the body first. This would be followed by insertion and deployment of the spreader mesh and expansion of the surgical cavity. Afterwards, thecannula216 on the endo-surgical device would be introduced into the surgical cavity through the already introduced spreader cannula, as shown, more particularly, inFIGS. 22A and 22B. In other words, a first cannula that allows introduction of a spreader device is inserted into the surgical area. The surgical cavity is maintained by inserting the spreader device. Finally, asecond cannula216 containing an imaging device and a surgical, diagnostic or therapeutic tool connected to a handle and an electronics module EM, as described above in connection withFIGS. 1-4D, is inserted through thefirst cannula212 and into the surgical cavity in order to perform the surgical procedure under visualization in a display desirably located within the sterile surgical field.
• In another embodiment shown inFIGS. 23A and 23B, aspreader device220 can be incorporated into an endo-surgical instrument, such as the device shown inFIGS. 1 to 4D. Through an actuator mechanism, the spreader can be expanded inside the body to produce the surgical cavity. This embodiment would allow the endoscopic instrument to simultaneously create the working space, illuminate the area, deliver a tool (as shown, for example, inFIGS. 23B and 24) and provide imaging for surgical procedures. In other words, a cannula containing an imaging device, a medical tool and fitted with the spreader device ofFIG. 21 (i.e., which is deployed by an actuator), can be connected to a handle and an electronics module as described above in connection withFIGS. 1-4D, which communicates to a display within the sterile surgical field where the surgeon can visualize the procedure in real-time.
• As an alternative to making the device in two parts (as shown inFIGS. 23A and 23B), the spreader device, imaging device, surgical tool, the handle, and the cable could be incorporated into a single sterile disposable unit that would connect to a separate electronics module and display unit enclosed in a sterile disposable enclosure and placed within the sterile surgical field as shown inFIG. 4D.
• In another embodiment of the present invention, the endo-surgical instrument could include the imaging device for visualization, together with the spreader device shown inFIG. 21, but may omit any type of surgical device. As shown inFIG. 23C, using an endo-surgical device in accordance with this embodiment, a separate surgical tool222 can be introduced into the surgical cavity through another small incision and between the mesh elements. This would give the surgeon the ability to manipulate the surgical tool with one hand while stabilizing the imaging instrument with the other hand and therefore avoiding distortion.
• In another embodiment shown inFIG. 24, the endo-surgical device224 includes the imaging device and a surgical tool, but not a spreader device. In this embodiment, thespreader device226 alone is first inserted through its own cannula to create and/or maintain the desired surgical cavity. After the spreader has been positioned and actuated, an endo-surgical device in accordance with one embodiment of the invention is inserted separately through another small incision and between the mesh elements into the surgical cavity to perform the procedure. The device ofFIG. 24, and the method described herewith, takes the function of maintaining the surgical cavity away from the endo-surgical instrument, consequently removing resistance to motion and facilitating delicate surgical maneuvers. If desired, as additionally shown inFIG. 24, aseparate knife228 or other instrument can be introduced into the surgical cavity through a third small incision. In this manner the function of maintaining a surgical cavity, the imaging function and the surgical tool function can be separated. If a separate surgical tool, such as a knife or other instrument, is used, the surgical instrument at the tip of the endo-surgical device ofFIG. 24 may be omitted or, alternately, not used, or only minimally used, in a particular procedure. This may be a good alternative for difficult procedures where precise control and stability is needed.
• The cannula and spreader device ofFIGS. 21-24, upon insertion and deployment, may be used to create the surgical cavity. Alternatively, the actual space to be maintained by the spreader may be created prior to insertion of the cannula and spreader by the surgeon using a different instrument, such as a hemostat, which is a commonly available generic surgical instrument.
• FIGS. 25-34 show particular embodiments of an inventive spreader device and assembly that can be used as described herein.
• Referring now toFIGS. 35A-36C, there is shown another surgical tool that can be implemented in connection with the instant invention. Referring toFIG. 35A, an embodiment of the present invention can include interchangeable cannulas with different tips for different purposes. A reusable ordisposable handle300 can be used with aninterchangeable cannula302. Anendoscope301 or, alternately, an electronic imaging device, can be included in thehandle300.FIG. 35B illustrates a retracted position of a tool, andFIG. 35C illustrates an exposed position of a tool. In an embodiment, the cannula can include two actuators. The first actuator can be anengagement mechanism304. Theengagement mechanism304 can be used to retract an angleddistal end303 of the cannula to expose a tool. The second actuator can be atrigger305 that can be used to control movement of a tool. In one embodiment, the tool can be a scissor-type. The scissor-type tool308 can include astatic blade306 and arotating blade307.
• It is further possible to include a plurality of actuatable tools in the cannula, as shown inFIGS. 36A-36C. More particularly, these figures show the operation of a cannula attached to a handle including a plurality of actuators, wherein the cannula includes both a spreader device to spread a fat pad or other interfering element away from a site and a scissor-type tool, for cutting. Thespreader310 can be used, for example, to isolate a region for imaging, cutting or performing other surgical, diagnostic or therapeutic procedures. In one embodiment, thespreader310 can be controlled using theengagement mechanism304 to retract thedistal end303 of thecannula302.
• Other tools can be used in addition to and/or instead of, the tools shown in the present figures.
The Handle:
• The system of the present invention additionally includes a light weight sterile handle connected to the cannula, a non-sterile reusable electronics module (EM) and a receiver-monitor unit. In another embodiment the EM can be disposable. In one particular embodiment of the invention, the non-sterile EM is inserted into a chamber in the handle and sealed closed. After closing this handle, it is sterile on the outside and can therefore be used as a surgical instrument in the sterile field. For example, such an endo-surgical device in accordance with the instant invention is shown inFIG. 1, wherein a disposable cannula including at least a portion of the imaging device and having a tip adapted for a particular surgical procedure is connected to the handle using a connector, for example, the feed-throughconnector35 ofFIG. 4A. Said connector connects the electronics of the cannula to the EM that has been inserted into the endo-surgical device handle. Once inserted into the handle, the EM becomes sealed in, for example, by thesterile cap32 of FIG.1,2,3,4A-4C which additionally may include a seal, so that, after closing it, the handle and cap assembly is sterile on the outside and can be used as a surgical instrument in the surgical sterile field.
• As also shown inFIG. 4A, theEM40 inside thehandle30 of the endo-surgical tool can communicate data, including processed image data, to areceiver42 which captures the data and relays it to adisplay50. Although shown inFIG. 4A as wirelessly communicating with the receiver, further embodiments include a wired connection between the handle and the receiver.
• The handle30 (FIGS. 1 and 2) fits in the surgeon's hand and is either sterilizable or, in another embodiment (FIG. 4D) comes incorporated with the cannula and cable connector as a unit in a sterile pack. It may include part of the surgical instrument activating mechanism such as the trigger orlever168. The unsterile EM40 (FIG. 2) is housed within the handle. The EM includes components that because of heat intolerance and chemical sensitivity may be difficult to sterilize. The handle section creates a barrier between the sterile field and the EM. In one particular embodiment (FIG. 2), before surgery, thereusable electronics module40 is dropped into an opening in the handle and sealed with acap32. Electrical connections to the imaging device in the cannula are established through a feed throughconnector35. In the case of fiberoptic lighting, fiberoptic cables will connect to the reusable electronic module which will include a light source. The handle section is then closed in a sealed fashion by thecap32. The seal can be provided by means such as a sealing ring, threaded engagement or tightly fitting surfaces. Actuators, such asactuator34, buttons and/or other means of controlling the functions can be present on the handle, with sealed feed-throughs to the EM. As mentioned previously, in one embodiment the cannula is disposable and the handle would be reused after sterilization, such as, in an autoclave. In another embodiment, the handle, the cannula and the connector cable are integrated and come as one single sterile packed unit which can be discarded after use.
• Additionally, in one particular embodiment (FIG. 3A), thehandle30 may include anarm36 to which adisplay54 can be attached. Theattachment port38 provides for connection of the display to the EM. The arm provides a mechanism for rotation of the display in any or all of three axes to accommodate the visualization needs of the surgeon.
Electronics Module
• Referring now toFIGS. 37-39, there is shown an integrated electronics module (EM)400, which may be of the same as, or similar to, theEM40 ofFIG. 2. TheEM400 is sized to be received within thehandle300 and designed to perform one or more of the following functions:
• • (1) provide power to the imaging device, part of which is located within the cannula;
  • (2) provide control signals to the cannula electronics, if necessary;
  • (3) provide power to one or more LEDs located within the imaging device or the prow of the cannula or, alternatively, provide light to be transmitted to the distal end of the cannula via the light channel of an endoscope, optical fibers or light tunnel;
  • (4) electronically process the image captured by the image sensor within the cannula or, alternatively, video capture and process an optical image from an endoscope inserted into the cannula;
  • (5) transmit the processed image wirelessly to a receiver coupled to a display or, alternatively, transmit the image via wire (USB or other) to a tethered monitor or display;
  • (6) record processed images for future downloading;
  • (7) provide power to the image processor, video camera, wireless transmitter and recorder within the EM and/or the display outside the EM; and.
  • (8) transmit raw data for processing outside the handle.
• The EM400 (FIG. 37) may include one, all or any combination of the following components: an image sensor, a video camera, an image processor, a light source, a power supply, a battery (rechargeable or not), a wireless transmitter, a recorder, a memory module (memory stick or chip), a connector, such as a USB type connector (see, for example,FIG. 4B). Note that, in one preferred embodiment, at least the image sensor and LED light source are located in the cannula, and not on theintegrated electronics module400. However, in such an embodiment, the EM would be in electrical communication with the electronics in the cannula through an electrical connector of which prongs410amay be part.
• TheEM400 is an integrated removable module that includes, among other components, the circuitry necessary for providing the functionality to the handle and/or cannula. For example, in an embodiment wherein the image sensor is located remotely from theEM400, i.e., towards the distal end of the cannula, theEM400 of that embodiment can include theelectronic circuitry420 needed to process and/or forward the information from the image sensor in the cannula. Additionally, in one preferred embodiment, theEM400 includes apower supply430 to power the instrument. If an image sensor, video camera, light source, etc., are included in theEM400, then thepower supply430 will additionally power those devices. In one particular embodiment, thepower supply430 is a rechargeable battery.
• Additionally, in one particular embodiment wherein the signals from the image sensor and/or image processor are relayed wirelessly to a display, the electronic circuitry on thecircuit board420 of theEM400 will additionally include a wireless transmitter to transmit the data to a remote receiver and/or display. TheEM400 can also include, if desired, a device for recording data, a light source, and/or a cable connector for connecting thehandle300, and thus theEM400, to a tethered display for displaying images captured at the distal end of the cannula. Aconnector434, (such as a USB connector, RCA jack, coaxial connector, FIREWIRE connector, or similar other) can also be included in thehandle300 in communication with theEM400, to provide an external connection to theEM400, through which images collected by the device can be output. Additionally, in one particular embodiment wherein thepower supply430 is rechargeable, theconnector434 can be of a type (such as USB) that, when connected to a source of power will recharge thepower supply430. A memory card or chip (not shown) can be incorporated into the EM and/or could interface with the EM, via a connector on the handle, to record image data sourced from the imaging device. Note that, if desired, thepower supply430 and/or other items making up theEM400 can be provided in a separate stand-alone unit connected to theEM400 through theconnector434.
• TheEM400 may be non-sterile and reusable. For example, theEM400 can be inserted into the handle for use in a procedure, and then removed after the procedure, so that the handle can be re-sterilized or disposed of. TheEM400 can then be replaced into the sterilized handle, or into a new handle, for immediate reuse in another procedure. Once theEM400 is inserted into the handle and sealed with a sterile cap432 (or32 ofFIGS. 1-4B), it is isolated in such a way that the outside surface of the completed assembly remains sterile and can be used within a sterile surgical field.
• In another embodiment (FIG. 4D) all or portions of theEM40 are located outside the handle and connected to the handle via acable52, which carries the raw image data from the imaging device at the tip ofcannula20.
Monitor or Display
• Referring back toFIGS. 1,3A-3B and4, it can be seen that thesystem10,10′,10″,10′″ and10″″ of the present invention includes adisplay50,54 that is, desirably, located within the surgical field. The purpose of thedisplay50,54 is to provide the surgeon with a real-time image without shifting their gaze from the sterile surgical site, as captured by the imaging device located in thecannula20.
• As shown more particularly inFIG. 3A, adisplay54 can be attached to thehandle30′ through anarm36 with adirect connection38 to the EM (40′ ofFIG. 4A). Thearm36 permits rotation of thedisplay54 in any and all of three axes. Alternately, or in addition, as shown inFIGS. 1 and 4D, adisplay50 may be detached from thehandle30 and placed in any location that accommodates the visualization needs of the surgeon. When detached from the handle, thedisplay50 can receive image data from the EM wirelessly (as shown inFIG. 3B) via areceiver56, and/or through a wired connection (as shown inFIG. 1) or by direct connection to the EM (FIG. 4D). Thewired connection52 ofFIG. 1 can be accomplished using any type of suitable cable or connector, such as a coaxial cable, a USB cable, a FIREWIRE connection, or equivalent.
• Additionally, thedisplay50,54 can be of a known type of display, including, but not limited to, an LCD flat panel display or a TV monitor. Alternatively or in addition, images may be transmitted from the EM to one or more monitors or projectors that can display or project images to alternate locations inside or outside of the sterile surgical field.
• In one particular preferred embodiment, thedisplay50,54 receives processed images from theEM40′ located in the handle of the device. However, it should be understood that, if desired, thedisplay50,54 can be attached to a processing device that receives raw image data from the electronics module and processes the image data, externally from the handle, for display on thedisplay50.54.
• Referring toFIGS. 40A-40D, there are shown some alternate paths that could be used by the instant invention to carry image data to the display. For example, referring now toFIG. 40A, theimage sensor510 and theimage processor520 are located in the cannula and/or handle500, wherein processed images are provided to adisplay module530, which includes adisplay540, via thewired connection550. Note that, although the cannula/handle assembly500 is shown as a unitary group, for purposes of illustration, it is understood that the cannula can be detachably removable from the handle, or formed integrally with the handle, as described herein. Additionally, theimage sensor510 andimage processor520 can be located in the handle, in the cannula and/or distributed with some portion in each of the cannula and handle.
• Referring now toFIG. 40B, there is shown an embodiment wherein theimage sensor510 is located in the cannula and/or in the handle of theassembly560, while at least a portion of theimage processor520 is located in thedisplay module580. As such, the cannula/handle assembly560 sends raw image data from theimage sensor510 to thedisplay module580, via thewired connection550.
• The system ofFIG. 40C is substantially similar to that ofFIG. 40B, except that the cannula/handle assembly560′ includes awireless transmitter570, and thedisplay module580′ includes awireless receiver590, and the raw image data from theimage sensor510 is transmitted to theimage processor520, wirelessly. Similarly, the system ofFIG. 40D is substantially similar to that ofFIG. 40A, except that the cannula/handle assembly500′ includes awireless transmitter570, and thedisplay module530′ includes awireless receiver590, and the image data processed by theimage processor520 is transmitted from theassembly500′ to thedisplay module530′, wirelessly.
• Referring more particularly toFIG. 3A, there is shown one particular embodiment of an inline endo-surgical carpeltunnel release cannula20 that is connected to ahandle30′ including adisplay54. Thecannula20 can be straight, angled or curved as described elsewhere herein. Additionally, as shown inFIG. 3A, thehandle30′ can incorporate aconnector38, through which themonitor arm36 can connect thedisplay54 to theEM40′ handle30′. Additionally, cables, wires, and/or other connectors (not shown) can be wired through thearm36 to connect with or contact components within thehandle30′. For example, in one particular embodiment, a cable (not shown) extending between thedisplay54 and an EM in thehandle30′ can run within a lumen in thedisplay arm36. Alternately, thedisplay54 can receive images wirelessly from the EM in the handle.
• In one embodiment, the monitor can rotate about an axis perpendicular to the longitudinal plane of the handle. Additionally, thedisplay54 can be positioned for ease of viewing without moving thecannula20. Although shown in FIG.3A as being inline with thecannula20, if desired, the handle can be offset from the display, instead of inline. Further, if desired, the display can be detached from thehandle30′ and used wirelessly or through a wired connection (i.e., set on table while performing surgery).
• As discussed above in connection with the EM, thedevice10,10′,10″,10′″ and10″″ can include, a power supply (430 ofFIG. 39A). If desired, the power supply (430 ofFIG. 39A) can also provide power for thedisplay50,54.
• Additionally, to ensure that the system including thedisplay50,54 is sterile, thedisplay50,54 can be encased within a sterile plastic bag or case (60 ofFIG. 4D) that includes a pass-through connector, whenever it is within the surgical field. Such a pass-through connector can be of any known connection mechanism such as, for example, female connectors, coaxial, RCA, etc., that can provide electrical contact between thedisplay50,54 and/orEM40 inside the bag and components within thehandle30 orcannula20 while maintaining sterility. Additionally, the plastic bag can include a zip-lock closure mechanism or other air-tight closure mechanism. In one particular embodiment of the present invention, the plastic bag can include a flat or rigid section for maintaining a clear view of the monitor screen through the bag wall. In a further embodiment, the bag can include VELCRO™ or other adhesive to prevent bunching of the bag in front of the screen and/or to keep the flat or rigid section in place in front of the screen.
• If desired, the plastic bag can be omitted and the casing of thedisplay50,54 andEM40 can be made to be watertight. In such an embodiment, thewaterproof display50,54 is capable of being disinfected by a disinfectant solution such as, for example, CIDEX™, in order to render it sterile. Additionally, the joints, display, and handle of all of the present embodiments can be made waterproof for disinfection in a liquid disinfectant solution, to be rendered sterile.
• Alternately, or in a addition thereto, a conventional non-sterile monitor can be provided, which is of the type commonly found in surgical suites, on endoscopic towers, to which a non sterile receiver has been connected and to which a recording or printing device can be attached.
• Although some of the above-embodiments describe the use of thedisplay50,54 with an EM located in the handle, this is not meant to be limiting as can be readily seen in the embodiment illustrated inFIG. 4D. Rather, it can be seen how the cannulas and handles of the instant invention could provide images to a display connected to a video camera at the proximal end of an endoscope in communication with the EM. Such an embodiment is described in connection withFIG. 4B.
• FIGS. 42-44 show representative top, front and cross-sectional views of certain prior art devices, and illustrate that the cross-sectional dimensions of those devices either do not change over their lengths or taper proximally to distally. Referring now toFIG. 45, it can be seen in the top, front and cross-sectional views of one embodiment of the present invention that the cannula's geometry changes to achieved the before mentioned advantages.
• Among other advantages, by providing a display within the surgical field and, in particular, “inline” with the cannula, a surgeon can see the display while performing the surgical procedure, without turning to view an image to the side or far away from the operating site. The display of the instant invention eliminates the need for attaching the surgical device to an external monitor via a heavy video cable, and additionally eliminates the need for another heavy fiber optic cable to connect to a light source. The instant invention can shorten the labor required of nurses and technicians to set-up the system, thereby cutting set-up time.
• While the invention has been described with reference to certain embodiments, it will be understood by those skilled in the art that various changes can be made and equivalents can be substituted for elements thereof without departing from the scope of the invention. In addition, many modifications can be made to adapt a particular situation or material to the teachings of the invention without departing from the essential scope thereof. Therefore, it is intended that the invention not be limited to the particular embodiments disclosed as the best or preferred modes contemplated for carrying out this invention, but that the invention will include all embodiments falling within the scope of the appended claims.

Claims (73)

1. An endo-surgical device for use in a sterile surgical field, comprising:

a handle including a chamber therein, an opening in said handle providing access to said chamber;

an electronics module sized to be received into the chamber of said handle through said opening;

a cap, matingly coupled to said handle to close said opening after said electronics module has been received in said chamber, said cap mating with said handle to create a sterile seal usable in a sterile surgical field;

a cannula, including an imaging device therein, said imaging device being connected with said electronics module.

2. The endo-surgical device ofclaim 1, wherein said cannula further includes an implement for performing a surgical procedure.

3. The endo-surgical device ofclaim 1, wherein said electronics module is removably located within said chamber.

4. The endo-surgical device ofclaim 1, wherein said handle is reusable.

5. The endo-surgical device ofclaim 1, wherein said electronics module is reusable.

6. The endo-surgical device ofclaim 1, wherein said cannula is disposable.

7. The endo-surgical device ofclaim 2, wherein said cannula is removably connected to said handle and said handle includes at least one connector for connecting the imaging device in the cannula to the electronics module in the chamber, and for connecting controls on the handle to the actuators of the implement in the cannula.

8. The endo-surgical device ofclaim 1 wherein the electronics module in the chamber transmits image data received from the imaging device to a display.

9. The endo-surgical device ofclaim 1, wherein the image data is transmitted wirelessly to a receiver in communication with a display external to the endo-surgical device.

10. The endo-surgical device ofclaim 1, wherein the tip of the cannula distal from the handle is prow-shaped.

11. The endo-surgical device ofclaim 1, wherein the imaging device includes an image sensor located within said cannula and electrically connected with said electronics module.

12. The endo-surgical device ofclaim 1, wherein the imaging device includes an optical endoscope inserted into said cannula through a lumen and said endoscope is optically coupled with said electronics module.

13. A system for performing endo-surgery, comprising:

an endo-surgical device, including:

a handle including a chamber therein, an opening in said handle providing access to said chamber;

an electronics module sized to be received into the chamber of said handle through said opening;

a cap, matingly coupled to said handle to close said opening after said electronics module has been received in said chamber, said cap mating with said handle to create a sterile seal usable in a sterile surgical field;

a cannula, including an imaging device therein, said imaging device being connected with said electronics module; and

a display for displaying images from said electronics module, corresponding to image data received from the imaging device.

14. The system ofclaim 13, wherein said cannula further includes an implement for performing a surgical operation.

15. The system ofclaim 13, wherein said electronics module processes the raw data received from said imaging sensor and provides processed image data to said display.

16. The system ofclaim 13, wherein said image data is transmitted to said display wirelessly.

17. The system ofclaim 13, wherein said image data is transmitted to said display via a cable connector.

18. The system ofclaim 13, wherein said cannula is removably connected to said handle.

19. An endo-surgical device for use in a sterile surgical field, comprising:

a handle including a chamber therein, an opening in said handle providing access to said chamber;

an electronics module sized to be received into the chamber of said handle through said opening;

a cap, matingly coupled to said handle to close said opening after said electronics module has been received in said chamber, said cap mating with said handle to create a sterile seal usable in a sterile surgical field;

a cannula, including an imaging device therein, said imaging device being connected with said electronics module;

said cannula further including a medical device therein.

20. The endo-surgical device ofclaim 19, wherein said medical device is for performing a therapeutic procedure.

21. The endo-surgical device ofclaim 19, wherein said medical device is a cutting implement for performing a surgical operation.

22. The endo-surgical device ofclaim 19, wherein said medical device is a diagnostic implement.

23. The endo-surgical device ofclaim 19, wherein said medical device is a tissue spreader.

24. A method for performing an endo-surgical procedure, comprising the steps of:

providing an endo-surgical device including a cannula and a handle, the cannula including an imaging device therein, the handle including a chamber accessible through an opening in the handle;

inserting an electronics module into the chamber through the opening;

after inserting the electronics module, fixing a cap to the handle to close the opening and to create a sterile seal usable in a sterile surgical field; and

performing a surgical procedure with the endo-surgical device.

25. The method ofclaim 24, wherein a spreader is included within the cannula of the endo-surgical device and actuated using a device located at the handle.

26. The method ofclaim 24, wherein a spreader is included within the cannula of the endo-surgical device and actuated using a device located in the cannula.

27. The method ofclaim 26 wherein the endo-surgical device additionally includes a surgical implement for performing a surgical cutting operation.

28. The method ofclaim 25, wherein the spreader is separate from the endo-surgical device and is inserted separately from the endo-surgical device.

29. The method ofclaim 24 wherein the endo-surgical device includes a cutting implement for performing a surgical cutting operation.

30. The method ofclaim 29, wherein the cutting implement for performing the surgical cutting operation is introduced into the surgical cavity separately from the endo-surgical device.

31. The method ofclaim 24, further including the steps of:

removing the electronics module from the handle after the procedure; and

reusing the electronics module in another procedure.

32. An endo-surgical device, comprising:

a handle including a chamber therein, an opening in said handle providing access to said chamber;

an electronics module sized to be received into the chamber of said handle through said opening;

a cap, matingly coupled to said handle to close said opening after said electronics module has been received in said chamber, said cap mating with said handle to create a sterile seal usable in a sterile surgical field;

a cannula, including an imaging device therein, said imaging device being connected with said electronics module; and

said cannula further including at least one implement for performing a procedure during surgery.

33. The endo-surgical device ofclaim 32, wherein said implement is a spreader.

34. The endo-surgical device ofclaim 32, wherein said implement is a cutting implement.

35. A method for performing an endo-surgical procedure on a patient, comprising the steps of:

providing a medical device including a cannula and a handle, the cannula including an imaging device therein, the handle including a chamber accessible through an opening in the handle;

inserting an electronics module into the chamber through the opening;

after inserting the electronics module, fixing a cap to the handle to close the opening and to create a sterile seal usable in a sterile surgical field; and

inserting the cannula into the patient.

36. The method ofclaim 35, wherein a surgical cavity is created using the cannula during the inserting step.

37. The method ofclaim 35, wherein said medical device additionally includes a surgical implement.

38. The method ofclaim 37, further comprising the step of performing a surgical operation in the surgical cavity with the surgical implement.

39. The method ofclaim 38, wherein the surgical implement is a spreader.

40. The method ofclaim 38, wherein the surgical implement is a cutting instrument.

41. The method ofclaim 35, further comprising the step of performing a surgical operation in the surgical cavity.

42. An endo-surgical device, comprising:

a handle including a chamber therein, an opening in said handle providing access to said chamber;

an integrated electronics module sized to be received into the chamber of said handle through said opening, said integrated electronics module being removable from said handle;

said handle including a first connector for matingly engaging a second connector on said integrated electronics module when said integrated electronics module is seated in said chamber;

a cap, matingly coupled to said handle to close said opening after said electronics module has been received in said chamber; and

a cannula, including an imaging device therein, said imaging device being connected with said electronics module, via said first and second connector.

43. The endo-surgical device ofclaim 42, wherein said cannula is integral with said handle.

44. The endo-surgical device ofclaim 42, wherein said cannula is detachably connected to said handle via a third connector.

45. The endo-surgical device ofclaim 42, wherein said cannula further includes a medical device therein.

46. The endo-surgical device ofclaim 45, wherein said medical device is for performing a therapeutic procedure.

47. The endo-surgical device ofclaim 45, wherein said medical device is a cutting implement for performing a surgical operation.

48. The endo-surgical device ofclaim 45, wherein said medical implement is a diagnostic implement.

49. The endo-surgical device ofclaim 45, wherein said medical device is a spreader implement for at least one of creating and maintaining a surgical cavity in soft tissue.

50. An endo-surgical device for use in a sterile surgical field, comprising:

a sterile instrument including an imaging device;

an image processor located remotely from said sterile instrument and within the sterile surgical field;

a sterile display, in communication with said image processor, for receiving image information from said sterile instrument; and

said sterile display additionally being located within the sterile surgical field.

51. The endo-surgical device ofclaim 50, wherein said sterile display is rendered sterile by virtue of its inclusion in a sterile enclosure.

52. The endo-surgical device ofclaim 51, wherein said sterile enclosure is disposable.

53. The endo-surgical device ofclaim 51, wherein said sterile enclosure is reusable.

54. The endo-surgical device ofclaim 50, wherein said sterile instrument is disposable.

55. The endo-surgical device ofclaim 50, wherein the image information is transmitted from said instrument to said remote image processor wirelessly.

56. The endo-surgical device ofclaim 50, wherein the image information is transmitted from said instrument to said remote image processor via a cable connector.

57. The endo-surgical device ofclaim 50 wherein power for said sterile instrument is provided to said sterile instrument from a power source in said remote image processor.

58. The endo-surgical device ofclaim 50, wherein said sterile instrument includes a tool for performing a surgical procedure.

59. The endo-surgical device ofclaim 58, wherein said tool is a cutting implement.

60. The endo-surgical device ofclaim 58, wherein said sterile instrument includes actuators to deploy said tool.

61. The endo-surgical device ofclaim 50, wherein a power source is enclosed in said remote image processor.

62. The endo-surgical device ofclaim 50, wherein power is provided to said remote image processor via a cable from a power source located outside the sterile field.

63. The endo-surgical device ofclaim 56, wherein said cable connector is disposable.

64. The endo-surgical device ofclaim 50, wherein said remote image processor is reusable.

65. The endo-surgical device inclaim 50, wherein said imaging device wirelessly transmits image data to a receiver in said remote image processor.

66. The endo-surgical device ofclaim 50, wherein the distal end of the instrument prow-shaped.

67. The endo-surgical device ofclaim 50, wherein the sterile instrument further contains a battery for providing power to the instrument.

68. The endo-surgical device ofclaim 67, wherein said imaging device includes an image sensor located within said sterile instrument and electrically coupled with said remote image processor.

69. The endo-surgical device ofclaim 50, wherein said sterile instrument is a cannula containing a lumen and said imaging device includes an optical endoscope inserted into said cannula through said lumen, said optical endoscope being optically coupled with said remote image processor.

70. A method for performing an endo-surgical procedure in a sterile field, comprising the steps of:

providing in a sterile surgical field an endo-surgical device including:

a sterile instrument including an imaging device;

an image processor located remotely from the sterile instrument and within the sterile surgical field;

a sterile display, in communication with the image processor, for receiving image information from the sterile instrument; and

the sterile display additionally being located within the sterile surgical field;

inserting at least a portion of the sterile instrument into a surgical cavity.

71. The method ofclaim 70, wherein the sterile display is rendered sterile by virtue of enclosing a display in a sterile enclosure prior to bringing at least the display into the sterile surgical field.

72. The method ofclaim 70, wherein the sterile instrument includes a spreader actuated by a mechanism located on the sterile instrument.

73. The method ofclaim 70, wherein the sterile instrument includes a surgical implement for performing a surgical cutting operation.

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