Surgical Scalpel

Surgical scalpel and system particularly for use in a transverse carpal ligament surgical procedure

Abstract
The subject invention is a surgical scalpel, scalpel instrument and/or scalpel system (collectively, scalpel), particularly designed for use in a transverse carpal ligament surgical procedure, that evaluates an incision path with respect to a nerve in the incision path, and is used to perform the incision if appropriate. The scalpel emits an evaluation signal through a potential incision path through tissue captured by the scalpel. The scalpel utilizes the emitted evaluation signal to determine the presence of a nerve in the incision path. The dissection and evaluation (surgical) instrument includes a blade that is retractable relative to a target tissue capture area thereof. Evaluation may include determining the presence of a nerve before incision and/or the evaluating whether the target tissue has been appropriately captured. A warning is provided when the evaluation determines that a nerve is in the incision path and/or when the captured target tissue is determined to be inappropriate. Alternatively, the surgical instrument may disable extension of the blade when the evaluation determines that a nerve is in the dissection path and/or when the captured target tissue is determined to be inappropriate.

Claims
What is claimed is:

1. A method of incising a tissue structure comprising the steps of: capturing a tissue structure of a patient in an evaluation and incision instrument; evaluating an incision path through the captured tissue structure utilizing the evaluation and incising instrument; and performing an incision of the captured tissue structure utilizing the evaluation and incision instrument based on the evaluation.

2. The method of claim 1, wherein the step of performing an incision on the captured tissue structure utilizing the evaluation and incision instrument includes: extending at least a portion of a blade from an interior of a body of the evaluation and incision instrument to a position for incision of the tissue structure.

3. The method of claim 2, wherein the step of extending at least a portion of a blade from an interior of a body of the evaluation and incision instrument to a position for incision includes: extending the portion of the blade into a reception area formed by prongs of the evaluation and incision instrument.

4. The method of claim 1, wherein the step of evaluating a path of incision for the captured tissue structure utilizing the evaluation and incision instrument includes: applying an evaluation signal via the evaluation and incision instrument to an area proximate to and including the captured tissue structure; detecting the applied evaluation signal; and processing the detected evaluation signal to determine whether the evaluated incision path may be safely incised.

5. The method of claim 4, wherein detecting the applied evaluation signal includes utilizing a signal sensor located on the patient proximate the captured tissue structure to detect the applied signal; and wherein processing the detected evaluation signal to determine whether the incision path under evaluation may be safely incised includes determining whether a nerve is in the incision path.

6. The method of claim 4, wherein detecting the applied signal includes utilizing a portion of the evaluation and incision instrument to detect the applied signal.

7. The method of claim 6, wherein processing the detected evaluation signal to determine whether the incision path under evaluation may be safely incised includes determining impedance of the captured tissue structure.

8. The method of claim 7, further comprising: comparing the determined impedance of the captured tissue structure to a similar known tissue structure impedance value; and determining whether the incision path under evaluation may be safely incised based on the comparison.

9. The method of claim 1, wherein the tissue structure comprises a transverse carpal ligament.

10. A system for performing an incision on a tissue structure, the system comprising: a surgical instrument configured to i) capture a tissue structure; ii) evaluate whether an incision path of the capture tissue structure is clear of a nerve, and iii) incise the capture tissue structure when the incision path of the captured tissue structure is clear of a nerve; and a control unit in communication with the surgical instrument and configured to process evaluation data obtained via the surgical instrument in order to determine whether the incision path is clear of a nerve.

11. The system of claim 10, wherein the tissue structure comprises a transverse carpal ligament.

12. The system of claim 10, wherein said control unit is internal to the surgical instrument.

13. The system of claim 10, wherein said control unit is external to the surgical instrument.

14. The system of claim 10, wherein said surgical instrument includes: a first prong carrying an electrical evaluation signal emitter; and a second prong carrying an electrical evaluation signal detector.

15. The system of claim 14, wherein said first and second prongs are spaced to capture the tissue structure therebetween.

16. The system of claim 10, further comprising: a sensor in communication with the control unit and adapted to receive the evaluation signal, the sensor configured to be attached to skin of the patient proximate the tissue structure.

17. A surgical instrument comprising: a body; a channel formed in said body and open on one side thereof, said channel configured to receive target tissue for incising; a blade disposed in said body and configured to retractably extend into said channel; a signal transmitter carried by said body and adapted to transmit an evaluation signal into said channel; a signal receiver carried by said body and adapted to receive the transmitted evaluation signal; and circuitry coupled to said signal transmitter and said signal receiver and adapted to control said signal transmitter, monitor said signal receiver, and evaluate an incision path through the target tissue.

18. The surgical instrument of claim 17, wherein the blade is manually extendable from and retractable into said body.

19. The surgical instrument of claim 17, wherein said circuitry is internal to said body.

20. The surgical instrument of claim 17, wherein said circuitry is external to said body.

21. The surgical instrument of claim 17, wherein said body includes: a first prong carrying said signal transmitter; and a second prong carrying said signal receiver; said channel being defined between said first and second prongs.

22. The surgical instrument of claim 17, wherein said circuitry is adapted to evaluate an incision path through the target tissue by analyzing signal attenuation of an evaluation signal transmitted by said signal transmitter and received by said signal receiver caused by the target tissue captured within said channel.

23. A surgical instrument comprising: a body; a channel formed in said body and open on one side thereof, said channel configured to receive target tissue for incising; a blade disposed in said body and configured to retractably extend into said channel; a signal transmitter carried by said body and adapted to transmit an evaluation signal into said channel; circuitry coupled to said signal transmitter and said signal receiver and adapted to control said signal transmitter, monitor said signal receiver, and evaluate an incision path through the target tissue; and a signal receiver connected to said circuitry and adapted to receive the transmitted evaluation signal.

24. The surgical instrument of claim 23, wherein said signal receiver comprises a skin attachable band.

25. The surgical instrument of claim 23, wherein circuitry is adapted to evaluate an incision path through the target tissue by monitoring a nerve for a response signal caused by an evaluation signal transmitted by said signal transmitter and received by said signal receiver.

Medical Supplies Patent

Description
entire or full dissection).

[0048] The system 10 includes a surgical instrument 12 that is connected to a control or processing unit, module or the like 14. The surgical instrument 12 is adapted, configured and/or operative to receive, hold or capture tissue (e.g. a TCL) targeted for dissection or incising (i.e. target tissue) and evaluate the target tissue (itself) and/or a dissection or incision path through the target tissue before dissection/incision. Evaluation includes, but is not limited to, determining the presence of a nerve in the dissection/incision path, and/or evaluating whether the target tissue is appropriate and/or has been appropriately retained.

[0049] The control/processing unit 14 is adapted, configured and/or operative to provide control and/or similar signals to the surgical instrument 12 for operation of the surgical instrument 12 as described herein. The control/processing unit 14 is further adapted, configured and/or operative to receive evaluation and/or similar signals from the surgical instrument 12 in order to provide the functionality and/or features of the system 10 and/or scalpel 12 as described herein.

[0050] The system 10 may also include an independent nerve or evaluation signal sensor 16 that is connected to the control/processing unit 14. The nerve sensor 16 is configured, adapted and/or operative to receive or detect a nerve evaluation (evaluation) signal from a nerve and provide a nerve detection signal to the control/processing unit 14. The nerve sensor, in one form, particularly monitors a nerve or nerves for conduction of an evaluation signal input to the nerve(s) at a remote location. The remote location, in this case, is the surgical instrument 12. The control/processing unit 14 is further adapted, configured and/or operative to receive the nerve detection signal from the nerve sensor 16 in order to provide the functionality and/or features of the system 10 as described herein. Nerve sensor data, without being limiting, allows the control/processing unit 14 to determine whether the target tissue is correct and/or whether the incision path is clear for incision.

[0051] The control/processing unit 14 includes processing circuitry/logic represented by block 17. Program instructions (software or firmware) 18 may be provided for operation of the system 10. Additionally, the control/processing unit 14 may include data storage 19 in the form of a hard drive, memory or the like as necessary for storage of data, program instructions 18 as necessary, tables and/or the like. The control/processing unit 14 may operate on DC (such as via a battery or batteries) or AC electricity as appropriate, and as represented by the power box 13. In accordance with an aspect of the subject invention, warning indicia 15 is provided. Such warning indicia may be in the form of a light, lights or other visual indicia, or in the form of a sound, sounds or other audible indicia. The warning indicia 15 may be a combination of visual and audible indicia. A warning is provided to the user of the surgical instrument 12 when an evaluation determines that a nerve is in a dissection/incision path and/or when the captured target tissue itself is determined to be inappropriate. Alternatively, or in addition to the audible and/or visual warning indicia, the surgical instrument may disable extension of the blade when the evaluation determines that a nerve is in the dissection path and/or when the captured target tissue is determined to be inappropriate (as represented by the blade intervention box 20 associated with the surgical instrument 12).

[0052] A display 21 may also be provided in the system 10. The display 21 is connected to the control/processing unit 14 and is configured, adapted and/or operative to receive video signals from the control/processing unit 14 and show or present the video information. Such video information may include a visual indication of the outcome of a target tissue (dissection/incision path) evaluation (i.e. visually indicating whether there is or is not a nerve in the dissection/incision path) as well as other video information or data.

[0053] The system 10 utilizes the surgical instrument 12 to perform an evaluation of a dissection/incision path through target tissue captured by or retained in the surgical instrument. The surgical instrument 12 may perform a dissection/incision path evaluation with or without the independent nerve sensor (detector) 16 typically depending on the system embodiment. The surgical instrument 12 includes an evaluation signal emitter/transmitter or emitters/transmitters (collectively, emitter) 24 as well as an evaluation signal detector/receiver or detectors/receivers (collectively, detector) 26. The signal emitter 24 provides an evaluation signal. The signal detector 26 monitors for any portion of the evaluation signal. The emitter and detector pair may be used for evaluating the appropriateness of one or both of the captured tissue and the potential incision path.

[0054] In the case where the nerve sensor 16 is used, particularly for one aspect of evaluation, one form thereof may be a wrist band sensor, wrap sensor or similar device that is adapted to fit on the arm or wrist of the patient. The nerve sensor 16 detects evaluation signals from the ulnar and/or median nerves after an evaluation signal is applied to an upstream connecting nerve by the emitter 24 of the surgical device 12. The emitter 24 is configured, adapted and/or operative to emit, transmit, radiate or the like, an evaluation signal. The evaluation signal is directed through the target tissue preferably, but not necessarily, under the control of the control/processing unit 14. The form of the evaluation signal and thus the emitter/detector pair but may be any such form and/or type.

[0055] The detector 26 is adapted, configured and/or operative to detect or sense any portion of the emitted evaluation signal. The detector 26 either provides a detection signal (i.e. a signal indicating that the evaluation signal has been detected) to the control/processing unit 14 when the evaluation signal has been detected, or provides the detected signal to the controller 14 for the controller to determine whether the detected signal was the evaluation signal. The control/processing unit 14 utilizes the detection and/or evaluation signal for making and/or implementing the various evaluations and/or control features/functions.

[0056] Referring now to FIG. 2, there is depicted another exemplary scalpel system, generally designated 30, for performing evaluation of tissue of a patient with respect to a potential dissection/incision path of the tissue in the same or like manner as the system 10. Without being limiting, the scalpel system 30 is adapted, configured and/or operative to receive, capture, surround, retain, etc. an amount of tissue such as a ligament for incising an amount thereof, evaluate a proposed incision path through the tissue (i.e. target tissue), and incise the target tissue based on the evaluation. In one form, the evaluation comprises determining if a nerve is in the incision path. In another form, the evaluation comprises determining if the tissue itself is proper for incising. The scalpel system 30 preferably, but not necessarily, provides visual and/or audible feedback regarding the evaluation.

[0057] The system 30 allows the dissection/incision (collectively, incision) of the tissue with respect to the particular dissection/incision path (collectively, incision path). Particularly, the system 30 provides a system, method and/or apparatus for evaluating the appropriateness of the target tissue itself and/or an incision path through target tissue, particularly internal target tissue, of a patient and for dissecting or incising the target tissue based on the evaluation during a surgical procedure. It should be appreciated that while the present principles will be described in connection with surgery on a transverse carpal ligament of a patient, the present principles are not applicable exclusively to the evaluation and incision of the transverse carpal ligament. Thus, while the present principles are utilized in describing evaluation and/or incision with respect to the transverse carpal ligament, the present principles are applicable to evaluation and incision of other body tissue.

[0058] In general, the system, method and/or apparatus 30 is provided for evaluating the appropriateness of target tissue and/or a dissection or incision path through target tissue and for dissecting or incising the target tissue based on the evaluation. The system, method and/or apparatus is particularly suited for use on a transverse carpal ligament (TCL) during a surgical procedure undertaken thereon from a small incision/dissection of a portion or part thereof up to a standard carpal tunnel release (CTR) procedure (i.e. on an entire or full dissection).

[0059] The system 30 includes a surgical instrument 32 that is connected to a control or processing unit, module or the like 34. The surgical instrument 32 is adapted, configured and/or operative to receive, hold or capture tissue (e.g. a TCL) targeted for dissection or incising (i.e. target tissue) and evaluate the target tissue (itself) and/or a dissection or incision path through the target tissue before dissection/incision. Evaluation includes, but is not limited to, determining the presence of a nerve in the dissection/incision path, and/or evaluating whether the target tissue is appropriate and/or has been appropriately retained.

[0060] The control/processing unit 34 is adapted, configured and/or operative to provide control and/or similar signals to the surgical instrument 32 for operation of the surgical instrument 32 as described herein. The control/processing unit 34 is further adapted, configured and/or operative to receive evaluation and/or similar signals from the surgical instrument 32 in order to provide the functionality and/or features of the system 30 and/or scalpel 32 as described herein.

[0061] The system 30 may also include an independent nerve or evaluation signal sensor 36 that is connected to the control/processing unit 34. The nerve sensor 36 is configured, adapted and/or operative to receive or detect a nerve evaluation (evaluation) signal from a nerve and provide a nerve detection signal to the control/processing unit 34. The nerve sensor, in one form, particularly monitors a nerve or nerves for conduction of an evaluation signal input to the nerve(s) at a remote location. The remote location, in this case, is the surgical instrument 32. The control/processing unit 34 is further adapted, configured and/or operative to receive the nerve detection signal from the nerve sensor 36 in order to provide the functionality and/or features of the system 30 as described herein. Nerve sensor data, without being limiting, allows the control/processing unit 34 to determine whether the target tissue is correct and/or whether the incision path is clear for incision.

[0062] The control/processing unit 34 includes processing circuitry/logic represented by block 37. Program instructions (software or firmware) 38 may be provided for operation of the system 30. Additionally, the control/processing unit 34 may include data storage 39 in the form of a hard drive, memory or the like as necessary for storage of data, program instructions 38 as necessary, tables and/or the like. The control/processing unit 34 may operate on DC or AC electricity as appropriate, and as represented by the power box 33. In accordance with an aspect of the subject invention, warning indicia 35 is provided. Such warning indicia may be in the form of a light, lights or other visual indicia, or in the form of a sound, sounds or other audible indicia. The warning indicia 35 may be a combination of visual and audible indicia. A warning is provided to the user of the surgical instrument 32 when an evaluation determines that a nerve is in a dissection/incision path and/or when the captured target tissue itself is determined to be inappropriate. Alternatively, or in addition to the audible and/or visual warning indicia, the surgical instrument may disable extension of the blade when the evaluation determines that a nerve is in the dissection path and/or when the captured target tissue is determined to be inappropriate (as represented by the blade intervention box 40 associated with the surgical instrument 32).

[0063] A display 41 may also be provided in the surgical instrument 32 such as in the form of an LCD module or the like. The display 31 is connected to the control/processing unit 34 and is configured, adapted and/or operative to receive video signals from the control/processing unit 34 and show or present the video information. Such video information may include a visual indication of the outcome of a target tissue (dissection/incision path) evaluation (i.e. visually indicating whether there is or is not a nerve in the dissection/incision path) as well as other video information or data. Other video and/or visual information may also be shown on the display 31.

[0064] The surgical instrument 32 is utilized to perform an evaluation of a dissection/incision path through target tissue captured by the surgical instrument 32. The surgical instrument 32 may perform a dissection/incision path evaluation with or without the nerve sensor 36. In this regard, the surgical instrument 32 includes an evaluation signal emitter/transmitter or emitters/transmitters as well as an evaluation signal detector/receiver or detectors/receivers (collectively, emitter) 44 as well as an evaluation signal detector/receiver or detectors/receivers (collectively, detector) 46. The signal emitter 44 provides an evaluation signal. The signal detector 46 monitors for any portion of the evaluation signal. The emitter and detector pair may be used for evaluating the appropriateness of one or both of the captured tissue and the potential incision path.

[0065] In the case where the nerve sensor 36 is used, particularly for one aspect of evaluation, one form thereof may be a wrist band sensor, wrap sensor or similar device that is adapted to fit on the arm or wrist of the patient. The nerve sensor 36 detects evaluation signals from the ulnar and/or median nerves after an evaluation signal is applied to an upstream connecting nerve by the emitter 44 of the surgical device 32.

[0066] The emitter 44 is configured, adapted and/or operative to emit, transmit, radiate or the like, an evaluation signal. The evaluation signal is directed through the target tissue preferably, but not necessarily, under the control of the control/processing unit 34. The form of the evaluation signal and thus the emitter/detector pair but may be any such form and/or type.

[0067] The detector 46 is adapted, configured and/or operative to detect any portion of the emitted evaluation signal. The detector 46 provides detection signals to the control/processing unit 34 for processing thereof as necessary. The control/processing unit 34 utilizes the detection signals for making and/or implementing the various evaluations, warnings, video, and/or control features/functions as necessary.

[0068] The systems 10 and 30 may be embodied in various designs. FIGS. 3 and 4 depict two such exemplary embodiments. While not every feature of the systems 10 and 30 is particularly shown in the embodiments of FIGS. 3 and 4, it should be understood that the embodiments of FIGS. 3 and 4 (and other embodiments) have the various features and/or functions of the systems 10 and/or 30.

[0069] Referring to FIG. 3 there is shown an exemplary embodiment of a surgical instrument or scalpel generally designated 50. The surgical instrument 50 has a body 52 that is preferably made of a metal, but may be made of a plastic, ceramic, composite and/or any other suitable surgical grade material. The body 52 has a handle or handle portion 54 in the shape of a rod. The body 52 defines a tissue reception/evaluation portion or head 56 disposed at one end of the handle portion 54. The tissue reception/evaluation portion 56 of the exemplary embodiment of the surgical instrument is in an exemplary shape of a U, tuning fork or the like and thus defines an open channel, slot or the like 62. In this embodiment, a first prong 58 and a second prong 60 define the head 56 and thus also defines the tissue reception or capture area 62. Other manners of defining a reception area and/or reception area configurations in a body for the purposes of the present invention are contemplated. The tissue reception area 62 is sized to accommodate the target tissue.

[0070] The first prong 58 carries one or more evaluation signal emitters 64 each of which is in communication with a control/processing unit 68 that is here carried in the handle 54. Each emitter 64 is operative to generate or produce an evaluation signal and emit or transmit the evaluation signal into the reception area 62. The second prong 60 carries one or more evaluation signal detectors 66 each of which is in communication with the control/processing unit 68. Each detector 66 is operative to receive or detect the evaluation signal emitted by the emitter(s) 64 into the reception area 62 and/or through target tissue.

[0071] The body 52 also has a channel, slot or the like 70 that extends from a point interior to the reception area 62 to inside the handle portion 54. The channel 70 is configured to receive a blade, knife, scalpel or the like (collectively, blade) 72. The blade 72 is extendable and retractable relative to (from) the handle 54. Particularly, while the blade 72 is shown in FIG. 3 in a fully retractable position, the blade 72 is movable within the channel 70 (represented by the double-headed arrow) such that at least a portion of the blade 72 (e.g. a tip 73 of the blade 72) extends into the tissue reception area 62. In one form, the blade 72 may be manually extendable and/or retractable from and/or into the handle 54. In another form, the blade 72 may be automatically extendable and/or retractable from and/or into the handle 54. In yet another form, the blade 72 may be a combination of both manual and automatic manners of extending and/or retracting the blade 72 or blade tip/portion 73 from and/or into the handle 54.

[0072] It should be appreciated that a blade is only exemplary of a cutting means that is associated with the surgical instrument or scalpel. Thus other cutting means such as a laser, radio frequency energy, other electromagnetic energy, ultrasound and/or the like may be used in place of the blade 72. In all cases, the cutting means (collectively, "blade") is configured to be retracted, off, idle, or the like when not used and extended, on, active or the like when in use. Moreover, the blade may be carried and/or stowed in places other than the handle.

[0073] The body 52 carries a display 74 that is connected to the control/processing unit 68. Without being limiting, the display 74, preferably in the form of an LCD screen or the like, is used to provide evaluation results and/or warnings in the form of symbols, text, charts, and/or the like. The surgical instrument 50 may also provide audible warnings and/or results.

[0074] An external nerve sensor 80 in the form of a band or wrap may provide detection signals to the surgical instrument 50 via a connector 78 that is configured to be received in a receptacle 76. The receptacle 76 allows signals from the wrap 80 to be received by the control/processor 68. The control/processor may also provide signals to the wrap 80. While not specifically shown, the surgical instrument 50 may incorporate blade intervention as discussed in connection with FIGS. 1 and 2.

[0075] Referring now to FIG. 4 there is shown another exemplary embodiment of a surgical instrument generally designated 90. The surgical instrument 90 has a body 92 that is preferably made of a plastic, but may be made of a metal or any other suitable surgical grade material. The body 92 has a handle or handle portion 94 in the shape of a rod. The body 92 defines a tissue reception/evaluation portion or head 96 disposed at one end of the handle portion 94. The tissue reception/evaluation portion 96 is curved in shape and thus defines an open channel, slot or the like 62. In this embodiment, a first curved finger 98 and a second curved finger 100 define the head 96 and thus also defines the tissue reception or capture area 102. Other manners of defining a reception area in a body for the purposes of the present invention are contemplated. The tissue reception area 102 is sized to accommodate the target tissue.

[0076] The first finger 98 carries one or more evaluation signal emitters 104 each of which is in communication with a control/processing unit 108 that is here carried in the handle 94. Each emitter 104 is operative to generate or produce an evaluation signal and emit or transmit the evaluation signal into the reception area 102. The second finger 100 carries one or more evaluation signal detectors 106 each of which is in communication with the control/processing unit 108. Each detector 106 is operative to receive or detect the evaluation signal emitted by the emitter(s) 104 into the reception area 102 and/or through target tissue.

[0077] The body 92 also has a blade, knife, scalpel or the like (collectively, blade) 112. The blade 112 is preferably fixed in position, but may be extendable and retractable relative to (from) the handle 94 if desired. A tip 113 of the blade 112 extends into the tissue reception area 102. The control/processing unit 108 is connectable to other devices and/or power (if not provided for by batteries carried in the handle 94) as represented by the double-headed arrow 116.

[0078] In FIG. 4, a transverse carpal ligament (TCL) is shown as captured, received, held, retained or the like by the surgical instrument 90. It should be appreciated that while the subject invention is shown and/or described herein in connection with incising a transverse carpal ligament, (such as in a carpal tunnel release (CTR) procedure), the principles of the subject invention are applicable to other types of tissue and/or surgical procedures.

[0079] The surgical instrument 90 of FIG. 4 is ready to perform an evaluation on the TCL having already captured the TCL in the reception area 102. One or more emitters 64 provide the evaluation signal. The evaluation signal may comprise one or more evaluation signals from one or more of the emitters 104. Each evaluation signal from an emitter 104 is under control of the control/processing unit 108 such that any pattern or arrangement of evaluation signals may be emitted. Various purposes may require various patterns.

[0080] One or more of the detectors 106 receive the evaluation signal(s) as transmitted through the TCL. Each detector 106 provides a detection signal to the control/processing unit 108. Each detector/detection signal and/or a collective detection signals provides data to the control/processing unit 108.

[0081] Referring now to FIG. 5, there is depicted a representation of a manner of utilizing an embodiment of the surgical instrument to perform a surgical procedure, particularly a surgical procedure on a transverse carpal ligament (TCL). In FIG. 5, there is depicted a hand or upper forearm 120 of a patient. A wrist area 122 has been opened to reveal the transverse carpal ligament 124. It should be appreciated that the opening to the wrist is not intended to be a surgical guide, but is only intended for illustrative purposes. As such, the size of the opening depends on the nature of the surgical procedure and/or the size of surgical instrument 126. The surgical instrument 126, as with all of the surgical instruments described herein, may be any size overall but particularly with respect to certain portions thereof. The surgical instrument 126 may be sized according to the type of surgical procedure and/or target tissue to be incised.

[0082] The surgical instrument 126 is shown ready to capture the TCL 124 in its reception area 128. A nerve sensor wrap 130 is shown on the forearm of the patient for remotely (from the TCL and/or the surgical instrument 126) detecting nerve evaluation signals emitted from the surgical instrument 126. In this embodiment, the remote nerve sensor 130 is coupled via communication line 131 to the surgical instrument 126 (or direct to the controller). The nerve sensor 130 thus provides its nerve evaluation detection signals to the surgical instrument. The surgical instrument 126 may be coupled to a computer 132. The computer 132 or controller may receive and utilize data from the surgical instrument 126 and/or may provide control signals to the surgical instrument 126.

[0083] The nerve is thus evaluated to determine the presence of the emitted signal. The emitted signal may be in a particular pattern, form, or shape. The detector or sensor may determine whether the particular emitted signal is the received signal and provide a signal indicating same (detector does the evaluation). The detector or sensor may merely receive the signal and provide the received signal to the computer or controller for the computer or controller to make an evaluation.

[0084] Referring now to FIG. 6, there is depicted a flowchart, generally designated 140, of an exemplary manner of performing a procedure on a transverse carpal ligament in accordance with the present principles using any one of the systems described herein. It should be appreciated that while the technique is described in terms of a procedure on a transverse carpal ligament, the principles are applicable to other tissue structures.

[0085] In step 142, a transverse carpal ligament (TCL) is captured in the surgical instrument. Capturing includes, but it not limited to, holding, retaining and/or surrounding the TCL. Once captured, a prospective incision path is evaluated in step 144. The surgical instrument defines the prospective incision path. Particularly, the configuration and/or placement of the knife of the surgical instrument that is within the tissue reception area defines the incision path in the target tissue (e.g. the TCL). Evaluation of the incision path determines whether the prospective incision path is free or devoid of any nerves and/or whether the captured TCL (tissue) itself is appropriate for incising.

[0086] Thereafter, in step 146, the TCL may be incised through the incision path utilizing the surgical instrument based on the evaluation. Particularly, if it is determined by the evaluation that there is a nerve in the incision path and/or that the captured tissue is inappropriate, a warning or warnings are provided by or via the surgical instrument, and/or the blade is blocked from the ability to incise tissue or caused to not extend into the tissue reception area of the surgical instrument. If the evaluation determines that the incision path is clear of nerves and/or that the appropriate tissue (type and/or amount) has been captured, the surgical instrument is used to perform the incision.

[0087] FIG. 7 depicts a flowchart illustrating an exemplary manner of performing the evaluation step 144 of the flowchart of FIG. 6. It should be appreciated that the evaluation of the incision path may take various forms and/or may involve several types of evaluations. The flowchart of FIG. 7 provides one method with respect to the presence of a nerve or nerves in the incision path.

[0088] In step 150, the surgical instrument generates and emits an evaluation signal. In step 152, the emitted evaluation signal is monitored. In one form, the surgical instrument itself monitors the evaluation signal with integral detectors. In another form, an external nerve sensor is utilized that is placed on the patient. In step 154, the detected evaluation signal is the processed to determine whether a nerve is in the prospective incision path.

[0089] FIG. 8 depicts a flowchart illustrating another exemplary manner of performing the evaluation step 144 of the flowchart of FIG. 6. It should be appreciated that the evaluation of the incision path may take various forms and/or may involve several types of evaluations. The flowchart of FIG. 8 provides another method with respect to the presence of a nerve or nerves in the incision path.

[0090] In step 156, the surgical instrument generates and emits an evaluation signal. In step 158, the emitted evaluation signal is monitored. The surgical instrument itself monitors the evaluation signal with integral detectors. In step 160, the detected evaluation signal is the processed to determine if the captured tissue (TCL) is appropriate.

[0091] It should lastly be appreciated that the methods described in connection with the flowcharts of FIGS. 6-8 may utilize more steps or may utilize less steps than shown and/or described herein. Moreover, the sequence of steps may change.

[0092] There is a plurality of advantages of the subject invention arising from the various features of the subject invention described herein. It will be noted that further alternative embodiments of the subject invention may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of the subject invention that incorporate one or more of the features of the subject invention and that fall within the spirit and scope of the subject invention.

  1. Guarded surgical scalpel with blade stripper lock to prevent accidental or inadvertent ejection of the blade
  2. Multi-bladed surgical scalpel
  3. Disposable surgical scalpel
  4. Surgical scalpel and system particularly for use in a transverse carpal ligament surgical procedure
  5. Disposable guarded surgical scalpel
  6. Lock-type disposal safe surgical scalpel
  7. Surgical scalpel with protective sheath
  8. Spring-actuated, retractable-bladed surgical scalpel
  9. Surgical scalpel
  10. Surgical scalpel incinerating device
  11. Surgical scalpel
  12. Multi-bladed surgical scalpel
  13. Shielded surgical scalpel
  14. Micromachined surgical scalpel
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