JP2018525129A - Medical device for removing implants using a laser cutting hypotube - Google Patents

Abstract

A method and device for isolating an implant, such as a pacemaker lead, from tissue surrounding an implant in a patient's vasculature system. Specifically, the surgical device includes a handle, an elongated inner sheath, and a circular cutting blade that extends from the distal end of the sheath when the handle is actuated. The circular cutting blade is configured to engage the tissue surrounding the implanted lead and cut such tissue in a coring manner as the surgical device translates along the length of the lead. This allows not only the lead, but any tissue that remains attached to the lead to enter the elongated shaft of the device. The surgical device has a cylindrical cam cylinder that rotates the blade in the handle assembly and a separate cam mechanism at the tip of the outer sheath assembly that extends and retracts and controls the blade. A first actuation of the handle causes the blade to rotate in a first direction, extends from the outer sheath and retracts into the outer sheath, and a second actuation of the handle causes the blade to rotate in a second direction; The cylindrical cam cylinder and cam mechanism cooperate to extend from the outer sheath and retract into the outer sheath. The inner and outer sheaths are constructed from laser cutting hypotubes, which allows surgical devices, particularly the sheath assembly, to have a smaller profile for navigating smaller vasculature.

Description

Cross-reference of related applications
[0001] This application is a "MEDICAL DEVICE FOR REMOVING AN IMPLANTED OBJECT" filed on February 20, 2015 claiming the benefit and priority of US Patent Act 119 and / or US Patent Act 120. Is a continuation-in-part of US patent application No. 14 / 627,851, which is filed on March 13, 2014, “SURGICAL INSTRUMENT FOR REMOVING AN IMPLANTED”. This is a continuation-in-part of International Application PCT / US Patent Application Publication No. 2014/026496 entitled “OBJECT”. International Application PCT / US Patent Application Publication No. 2014/026496 was filed on March 15, 2013. “SURGICAL INS RUMENT FOR REMOVING AN IMPLANTED OBJECT "claiming the benefit of and priority to names of U.S. Provisional Application No. 61 / 793,597 No. 35 USC §119 (e) paragraph referred. US patent application No. 14 / 627,851 entitled “MEDICAL DEVICE FOR REMOVING AN IMPLANTED OBJECT”, filed on February 20, 2015, is filed “MEDICAL DEVICE FOR REMOVING AN” on March 3, 2014. US Provisional Application No. 61 / 947,377 entitled “IMPLANTED OBJECT” and US Provisional Application No. 62 / 058,790 entitled “MEDICAL DEVICE FOR REMOVING AN IMPLANTED OBJECT” filed on October 2, 2014. And US Provisional Application No. 62 /, filed on February 9, 2015, named “MEDICAL DEVICE FOR REMOVING AN IMPLANTED OBJECT”. And No. 13,865, are also claimed under 35 USC 119 (e) term benefit and priority. This application is filed on August 28, 2015, US Patent Act 119 (e) of US Provisional Application No. 62 / 211,151 entitled “MEDICAL DEVICE FOR REMOVING AN IMPLANTED OBJECT USING LASER CUT HYPOTUBES”. It also claims the benefit and priority of the paragraph. The entirety of the above applications are hereby incorporated by reference for all of their teachings and purposes.

  [0002] The present disclosure relates generally to devices, methods and systems for separating tissue in a patient's vasculature, and more specifically, tissue attached to an implant, such as a lead, in the patient's vasculature. And a device for removing such implants.

  [0003] Surgically implanted cardiac pacing systems such as pacemakers and defibrillators play an important role in the treatment of heart disease. In 50 years since the first pacemaker was implanted, technology has made dramatic progress, and these systems have saved or improved countless quality of life. Pacemakers handle slow heart rhythms by increasing heart rate or by adjusting heart contractions for patients with some heart failure. Implantable defibrillators hold dangerous fast heart rhythms by sending electric shocks.

  [0004] Cardiac pacing systems typically include a timing device and a lead that are placed in the patient's body. Part of the system is a pulse generator that contains an electrical circuit and a battery, usually placed on the chest wall under the subcutaneous clavicle. To replace the battery, the pulse generator must be replaced by simple surgery every 5 to 10 years. Another part of the system includes a wire or lead that runs between the pulse generator and the heart. In pacemakers, these leads allow the device to increase heart rate by sending a small timed burst of electrical energy to make the heart beat faster. In a defibrillator, the lead is special to allow the device to convert a potentially dangerous fast rhythm (ventricular tachycardia or fibrillation) into a normal rhythm with a high-energy shock. It has a simple coil. In addition, the lead transmits information about the electrical activity of the heart to the pacemaker.

  [0005] For both of these functions, the lead must be in contact with heart tissue. Most leads pass through veins under the clavicle that connect to the right side of the heart (right atrium and right ventricle). In some cases, the lead is inserted through the vein and guided to the heart chamber where it is attached to the heart. In other cases, the lead is attached to the outside of the heart. Most leads have an anchoring mechanism such as a machine screw and / or hook at the end in order to remain attached to the myocardium.

  [0006] After the lead is implanted in the body, in a relatively short time, the body's natural healing process forms scar tissue along the lead and possibly at the tip thereof, thereby making it more secure to the patient's body. Fixed. The leads usually last longer than the device's battery, so when replacing, the leads are only reconnected to each new pulse generator (battery). Although the leads are designed to be permanently implanted in the body, sometimes it may be necessary to remove or remove these leads. Many reasons for removing a lead from a patient include, but are not limited to, infection, lead life, and lead failure.

  [0007] Lead removal or removal may be difficult. As mentioned above, the body's natural healing process forms scar tissue on the lead, along the lead, and possibly at the tip thereof, so that at least a portion of the lead is covered and applied to the patient's body. Furthermore, it is fixed firmly. In addition, leads and / or tissue become attached to the walls of the vasculature. Thus, both results increase the difficulty of removing the lead from the patient's vasculature.

  [0008] Various tools have been developed to extract leads more safely and successfully. Current lead extraction techniques include mechanical traction, mechanical devices, and laser devices. Mechanical traction is achieved by inserting a locking stylet into the hollow portion of the lead and then pulling and removing the lead. An example of such a lead locking device is described and shown in US Pat. No. 6,167,315 to Coe et al., Which is hereby incorporated by reference herein in its entirety for all of its teachings and purposes. Incorporated in the description.

  [0009] A mechanical device for extracting a lead includes one or more flexible tubes, called sheaths, that pass over the lead and / or surrounding tissue. As one of the sheaths advances, the tip (and possibly cooperating sheaths) expands, separates to separate the scar tissue from other scar tissue, including the scar tissue surrounding the lead, and A tip having a dilator, a separator and / or a cutting blade is included for cutting. In some cases, the tip (and sheath) also separates the tissue itself from the lead. Once the lead is separated from the surrounding tissue and / or the surrounding tissue is separated from the remaining scar tissue, the lead is inserted into the hollow lumen of the sheath for removal and / or Taylor Several other mechanical devices, such as the mechanical traction device previously described in US Patent Application Publication No. 2008/0154293, are removed from the patient's vasculature. The entirety of this patent application publication is hereby incorporated herein by reference for all of its teachings and purposes.

  [0010] Some lead extraction devices include a mechanical sheath having a trigger mechanism for extending a blade from the distal end of the sheath. An example of such a device and method used to extract a lead is described and shown in Grace U.S. Pat. No. 5,651,781, which is hereby incorporated by reference in its entirety. All are hereby incorporated herein by reference. Another example of a device having a trigger mechanism for extending a blade from the distal end of a sheath is US Patent Application No. 13 / 834,405 filed March 14, 2013. The entire patent application publication is hereby incorporated herein by reference in its entirety for all of its teachings and purposes.

  [0011] Controlling the amount of extension and retraction of the blades within the patient's vasculature is such that when the sheath and blades traverse a refracted path present in a particular vessel or physiological environment, and / or This is particularly important when trying to cut and / or separate tough surrounding tissue. Moreover, the use of such mechanical devices for lead removal can provide more fine control in certain cases, such as when the lead is placed and / or attached to a weak portion of the vasculature. Needed. For example, a typical human lead passes through the brachiocephalic vein, past the superior vena cava (“SVC”), and enters the right atrium of the heart. Tissue growth that occurs along the SVC and other locations along the brachiocephalic vein causes the lead to be removed from such locations, especially when the vein walls are thin and the surrounding tissue is especially fibers Risk and difficulty.

  [0012] Therefore, there is a need for devices, methods and / or systems, such as surgical devices that have the ability to accurately control the extension, retraction and rotation of the blades from within the outer sheath. For example, the blade initially rotates in one direction as it extends from the outer sheath and retracts into the outer sheath, and then rotates in the opposite direction during the same operation of the surgical device during subsequent expansion and retraction. Is desirable. The present disclosure relates to a surgical device having a cylindrical cam cylinder that rotates a blade in a handle assembly and a separate cam mechanism at the distal end of the outer sheath assembly that extends, retracts and controls the blade. It will be discussed. The cylindrical cam cylinder and cam mechanism rotate the blade in one direction when the blade initially extends from the outer sheath and retracts into the outer sheath, and extends from the outer sheath a second time and retracts into the outer sheath. Cooperate to rotate the blade in the second direction. For each operation of the handle, the blade rotates in one direction when it initially extends from the outer sheath and retracts into the outer sheath, and later when the blade extends from the outer sheath a second time and retracts into the outer sheath. Rotate in the direction of 2. Alternating the direction of rotation during rotation with the extension and retraction of the blade provides the effect of cutting the blade in one direction for each extension and retraction, thereby minimizing the possibility of the blade becoming stuck in the surrounding tissue. To do.

  [0013] A device for removing an implant from a blood vessel of a body according to this disclosure comprises an outer sheath assembly, an inner sheath assembly, and a sheath assembly comprising a pin, the outer sheath assembly comprising an outer sheath and An outer band, the outer band is coupled to the pin, the inner sheath assembly includes an inner sheath and a tip, the tip has a cutting surface, the inner sheath includes a proximal end and a distal end; The distal end of the inner sheath is coupled to the tip, the tip includes a cam slot for receiving the pin and cooperating with the pin, the handle assembly includes a trigger and a cylindrical cam cylinder, and the trigger includes the trigger pin. The cylindrical cam cylinder includes a cylindrical cam cylinder slot for receiving the trigger pin and cooperating with the trigger pin, and the proximal end of the inner sheath moves proximally in the longitudinal direction of the trigger pin The cylindrical cam cylinder rotates in both clockwise and counterclockwise directions, so that the tip is moved both clockwise and counterclockwise while the tip is moving in the longitudinal direction. It is connected to the cylindrical cam cylinder so as to rotate in the direction of.

  [0014] A device for removing an implant from a blood vessel of a body according to this disclosure or alternatively comprises a sheath assembly comprising an outer sheath assembly, an inner sheath assembly, and a pin, wherein the outer sheath assembly and the inner sheath The sheath assemblies each have a proximal end and a distal end, the distal end of the outer sheath assembly being pinned to the distal end of the inner sheath assembly, the inner sheath assembly being a distal end An inner sheath and a tip at the end, the tip has a cutting surface, the tip includes a slot for receiving the pin and cooperating with the pin, the handle assembly includes a trigger and a cylindrical cam cylinder; The trigger includes a trigger pin, the cylindrical cam cylinder includes a cylindrical cam cylinder slot for receiving the trigger pin and cooperating with the trigger pin, the proximal end of the inner sheath being proximal in the longitudinal direction of the trigger pin When moving, the cylindrical cam cylinder is coupled to the cylindrical cam cylinder by a trigger pin so that the cylindrical cam cylinder rotates in the first direction and the second direction, and the first direction is different from the second direction. The tip moves in the longitudinal direction while the cylindrical cam cylinder rotates in the first direction, and the tip moves in the longitudinal direction while the cylindrical cam cylinder rotates in the second direction. Moving.

  [0015] There is a need for devices, methods and / or systems, such as surgical devices that have the ability to accurately control the extension, retraction and rotation of the blades from within the outer sheath. For example, the blade initially rotates in one direction as it extends from the outer sheath and retracts into the outer sheath, and then rotates in the opposite direction during the same operation of the surgical device during subsequent expansion and retraction. Is desirable. The present disclosure relates to a surgical device having a cylindrical cam cylinder that rotates a blade in a handle assembly and a separate cam mechanism at the distal end of the outer sheath assembly that extends, retracts and controls the blade. It will be discussed. The cylindrical cam cylinder and cam mechanism are: (1) during the first operation of the device, the cylindrical cam cylinder rotates in a first direction, thereby causing the blade to (2) during the second actuation of the device, the cylindrical cam cylinder rotates in the second direction, thereby rotating the blade in the second direction while the blade extends and retracts To collaborate. Alternating the direction of rotation with the extension and retraction of the rotating blade provides a cutting action, thereby minimizing the possibility of the blade becoming stuck in the surrounding tissue.

  [0016] A device for removing an implant from a blood vessel of a body according to this disclosure comprises an outer sheath assembly, an inner sheath assembly, and a sheath assembly comprising a pin, the outer sheath assembly comprising an outer sheath and An outer band, the outer band is coupled to the pin, the inner sheath assembly includes an inner sheath and a tip, the tip has a cutting surface, the inner sheath includes a proximal end and a distal end; The distal end of the inner sheath is coupled to the tip, the tip includes a cam slot for receiving the pin and cooperating with the pin, the handle assembly includes a trigger and a cylindrical cam cylinder, the trigger being a trigger pin The cylindrical cam cylinder includes a cylindrical cam cylinder slot for receiving the trigger pin and cooperating with the trigger pin, and the proximal end of the inner sheath is (1) proximally in the longitudinal direction of the trigger pin. During the first actuation of the trigger to be moved, the cylindrical cam cylinder rotates in the first direction, thereby rotating the tip in the first direction while the tip moves in the longitudinal direction; (2) During the second actuation of the trigger to move the trigger pin proximally in the longitudinal direction, while the cylindrical cam cylinder rotates in the second direction, thereby moving the tip in the longitudinal direction, The front end portion is coupled to the cylindrical cam cylinder so as to rotate in the second direction.

  [0017] A device for removing an implant from a blood vessel of a body according to this disclosure comprises a sheath comprising a proximal end and a distal end, and a tip coupled to the distal end of the sheath, the tip The portion has a cutting surface, the handle assembly rotatably conveys the sheath, the handle assembly includes a trigger with a trigger pin, and the cylindrical cam assembly receives a trigger pin and cooperates with the trigger pin A cylindrical cam cylinder having a cylindrical cam cylinder slot, the cylindrical cam cylinder slot including a first slot portion and a second slot portion, and a follower guide that is rotatably conveyed by the cylindrical cam cylinder; During a first actuation of the trigger that moves the trigger pin proximally in the longitudinal direction, the follower guide causes the trigger pin to traverse the first slot portion, thereby causing the cylindrical Upon a second actuation of the trigger that rotates the cylinder and tip in a first direction and moves the trigger pin proximally in the longitudinal direction, the follower guide causes the trigger pin to traverse the second slot portion, thereby The cylindrical cam cylinder and the tip are rotated in the second direction.

  [0018] A device for removing an implant from a blood vessel of a body according to this disclosure comprises an outer sheath assembly, an inner sheath assembly, and a sheath assembly comprising a pin, the outer sheath assembly comprising an outer sheath and An outer band, the outer band is coupled to a pin, at least a portion of the outer sheath includes an outer hypotube, the inner sheath assembly includes an inner sheath and a tip, the tip has a cutting surface, and the outer At least a portion of the sheath includes an inner hypotube, the inner sheath includes a proximal end and a distal end, the distal end of the inner sheath is coupled to the tip, and the tip receives the pin and cooperates with the pin The handle assembly includes a trigger and a cylindrical cam cylinder, the trigger includes a trigger pin, and the cylindrical cam cylinder receives the trigger pin and receives the trigger pin. A cylindrical cam cylinder slot for cooperating with the inner sheath, wherein the proximal end of the inner sheath is (1) when the first actuation of the trigger moves the trigger pin proximally in the longitudinal direction, A second trigger that rotates in the direction of 1, thereby rotating the tip in the first direction while the tip is moving in the longitudinal direction, and (2) moving the trigger pin proximally in the longitudinal direction. The cylindrical cam cylinder rotates in the second direction during the operation of the cylindrical cam cylinder so that the distal end portion rotates in the second direction while the distal end portion moves in the longitudinal direction. Is bound to. Since the inner and outer sheaths are constructed from laser-cut hypotubes, the overall profile of the surgical device, particularly the sheath assembly, is smaller and the ability of the surgical device to navigate smaller vasculature is improved. .

  [0019] In the device according to paragraph [0018], the outer sheath assembly is stationary and the inner sheath assembly can rotate.

  [0020] In the device according to paragraph [0018] or [0019], the pin couples the distal end of the inner sheath assembly to the outer band of the outer sheath assembly.

  [0021] In the device according to any of the paragraphs [0018]-[0020], the handle assembly further comprises a spring assembly coupled to the trigger.

  [0022] In the device according to any one of paragraphs [0018] to [0021], the spring is a constant load spring.

  [0023] In the device according to any one of paragraphs [0018] to [0022], the outer hypotube is laser cut, and the inner hypotube is laser cut.

  [0024] In the device according to any of the paragraphs [0018] to [0023], the outer hypotube comprises a first outer segment and a second outer segment, and the inner hypotube comprises a first inner segment and a second outer segment. With an inner segment.

  [0025] In the device according to any of the paragraphs [0018]-[0024], the first outer segment is distal to the second outer segment and the first inner segment is distal to the second inner segment. It is in.

  [0026] In the device according to any one of paragraphs [0018] to [0025], the first outer segment has a first outer flexibility and a first outer length, and the second outer segment is the first outer segment. The first inner segment has a first inner flexibility and a first inner length, and the second inner segment has a second inner segment. It has an inner flexibility and a second inner length, the first outer flexibility is higher than the second outer flexibility, and the first inner flexibility is higher than the second inner flexibility. Is also expensive.

  [0027] In the device according to any one of paragraphs [0018] to [0026], the first outer flexibility is constant along the first outer length, and the second outer flexibility is the second. The first inner flexibility is constant along the first inner length, and the second inner flexibility is variable along the second inner length. It is.

  [0028] In the device according to any one of paragraphs [0018] to [0027], the first outer length is shorter than the first inner length.

  [0029] In the device according to any one of paragraphs [0018] to [0028], the first outer flexibility is lower than the first inner flexibility.

  [0030] In the device according to any one of paragraphs [0018] to [0029], the second outer flexibility is lower than the second inner flexibility.

  [0031] In the device according to any paragraph of [0018]-[0030], the inner distal end of the first inner length is axially aligned with the outer distal end of the first outer length; The first inner length is longer than the first outer length so as to overlap the first outer length in the axial direction.

  [0032] In the device according to any of the paragraphs [0018]-[0031], the second outer length has an outer distal end and an outer proximal end, and the second inner length is the inner distal end. And an outer proximal end of the second inner length and an axial direction relative to the second outer distal end of the second outer length and the proximal end of the third outer length. Overlap.

  [0033] In the device according to any one of paragraphs [0018] to [0032], the first inner segment has a constant pitch.

  [0034] In the device according to any of the paragraphs [0018] to [0033], the second inner segment has a variable pitch that increases from the distal end toward the proximal end.

  [0035] In the device according to any of the paragraphs [0018] to [0034], the first outer segment has a constant pitch.

  [0036] In the device according to any of the paragraphs [0018] to [0035], the second outer segment has a variable pitch that increases from the distal end toward the proximal end.

  [0037] In the device according to any of the paragraphs [0018]-[0036], the second outer segment has a variable angle that increases from the distal end toward the proximal end.

[0038] The phrases "at least one", "one or more", and "and / or" are unrestricted expressions and serve as both binding and separation. For example, “at least one of A, B, and C”, “at least one of A, B, or C”, “one or more of A, B, and C”, “A, B, or C” Each of the expressions “one or more of” and “A, B, and / or C” means A alone, B alone, C alone, A and B together, and A and C together. , B and C together, or A, B and C together. In the above expression, when each of A, B, and C refers to an element such as X, Y, and Z or a class of elements such as X _{1 to} X _n , Y _{1 to} Y _m, and Z _{1 to} Z _o The phrase includes a single element selected from X, Y and Z, a combination of elements selected from the same class (eg, X ₁ and X ₂ ), and a combination of elements selected from two or more classes It is intended to refer to (eg, Y ₁ and Z _o ).

  [0039] An entity of the term "a" or "an" refers to one or more of that entity. As such, the terms “a” (or “an”), “one or more”, and “at least one” are used interchangeably herein. It should also be noted that the terms “including”, “comprising”, and “having” are used interchangeably.

  A “cylindrical cam cylinder”, sometimes referred to as a “cylindrical cam”, is generally a groove (slot or channel) carved on the surface of a cylinder and a follower such as a pin that goes through the groove. Including. Cylindrical cam cylinders are generally used to convert rotational motion into linear motion parallel to the cylinder axis of rotation, or to convert linear motion parallel to the cylinder axis into rotational motion. For the purposes of this disclosure, unless otherwise specified, a cylindrical cam cylinder refers to a cylinder and a follower.

  [0041] A "groove" is a slit. For example, in this disclosure, slits are made in inner and outer sheaths that can be constructed from hypotubes. The kerf is made by using a laser, which cuts a slit in the hypotube.

  A “lead” is a conductive structure, and is generally an electrically insulated coil wire. The electrically conductive material is any conductive material, usually metals and intermetallic alloys. The outer sheath of insulating material is biocompatible and biostable (eg, does not dissolve in the body) and generally includes organic materials such as polyurethane and polyimide. Lead types include, without limitation, epicardial and endocardial leads. The lead is typically implanted through the skin or surgically into the body.

  [0043] The term "means" as used herein is to be given the broadest interpretation in accordance with 35 USC 112 (f). Thus, a claim incorporating the term “means” is intended to cover all structures, materials, or acts described herein, and all equivalents thereof. Furthermore, the structure, material, or operation, and equivalents thereof, include all that is described in the summary of the invention, the brief description of the drawings, the mode for carrying out the invention, the abstract, and the claims themselves. .

  [0044] "Serration", "saw edge", "saw blade" or other variations, as used herein, is a cutting surface having a notched edge or saw-like tooth It shall mean the configuration of A scored edge results in a plurality of smaller points (and thus a smaller contact area) to contact the material to be cut compared to an unscored blade. In addition, the pressure applied by each serrated contact is relatively large, and the contact is at a sharper angle with respect to the material to be cut. An example of a saw blade includes one where one notch touches another adjacent notch and the blade in between (if any) is very small, thereby providing a contact. There are numerous variations and / or features of serrations. For example, one type of serrated feature is referred to as a “crown”. As used herein, a “crown” -shaped saw blade or other variation, particularly when the blade is circular, is a combination of a knurled area and a knurled area that is royalty (eg, A blade having a plurality of indented areas and an adjacent indented area, similar to the crown of a king, queen, etc.). Additional types of “crowns” include “hook crowns”. As used herein, a “hook crown” -shaped saw blade or other variation shall mean a blade composed of a plurality of indentations and adjacent indented areas. The length of the unscored area rises to the next adjacent point at an angle that enhances the action of cutting in one direction of rotation, and the notch increases each engagement to promote tissue engagement at the hook-shaped point. Produced at an angle that provides a hook feature at the point.

  [0045] A "surgical implant" or "implant" is to replace, assist or stimulate a lost biological structure, or to treat a damaged biological structure, or A medical device manufactured to enhance, stimulate, or treat an existing biological structure. Medical implants are man-made devices as opposed to transplanted tissue, which is a living tissue that has been transplanted. In some cases, implants include, without limitation, electronic devices including artificial pacemakers, defibrillators, electrodes, and cochlear implants. Without limitation, some implants affect the living body, including subcutaneous drug delivery devices in the form of implantable tablets or drug eluting stents.

  [0046] A "vasculature" or "vasculature" is any part of the circulatory system and includes the heart, blood, and blood vessels such as arteries, veins, capillaries.

  [0047] All maximum numerical limits given throughout this disclosure are, as an alternative, any smaller numerical limits, as if such smaller numerical limits were explicitly written herein. It should be understood that All minimum numerical limits given throughout this disclosure, as an alternative, include any larger numerical limits as if such larger numerical limits were expressly written herein. Considered. All numerical ranges given throughout this disclosure are intended to include any narrower numerical ranges contained in such wider numerical ranges as if all such narrower numerical ranges were explicitly written herein. Is considered to be included.

  [0048] The foregoing is a simplified summary of the disclosure in order to provide an understanding of some aspects of the disclosure. This summary is not an extensive overview or an exhaustive overview of the present disclosure and the various aspects, embodiments, and configurations of the disclosure. It is not intended to identify key or critical elements of the disclosure or to delineate the scope of the disclosure, but as an introduction to the more detailed description presented below. It is a simplified representation of selected concepts of disclosure. As will be appreciated, other aspects, embodiments and configurations of the present disclosure may utilize one or more of the features specified above or described in detail below, either alone or in combination. can do.

  [0049] The accompanying drawings are incorporated into and form a part of the specification to illustrate some examples of the present disclosure. Together with the description, these drawings illustrate the principles of the present disclosure. These drawings are merely illustrative of the preferred and alternative manners in which the present disclosure may be made and used, and are to be construed as limiting the present disclosure to only those shown and described. Should not. Additional features and advantages of various aspects, embodiments, and configurations of the disclosure will become apparent from the following more detailed description, when illustrated by the drawings referenced below.

[0050] FIG. 5 is a perspective view of a human with the lead of the pacemaker placed in the venous system and the terminal electrode fixed to the heart chamber of the ventricle. One embodiment of a surgical device is shown inserted into the body and partially advanced over the lead. [0051] FIG. 12 is a front view of one embodiment of a surgical device. [0052] FIG. 10A is a cross-sectional view of a sheath assembly inside a blood vessel having an extensible and rotatable blade for removing a lead, according to one embodiment of the present disclosure. [0053] FIG. 3 is an internal view of one embodiment of the handle assembly of the surgical device shown in FIG. [0054] FIG. 4B is a perspective view of one embodiment of a trigger for the handle assembly shown in FIG. 4A. [0055] FIG. 4B is a front view of one embodiment of a cylindrical cam cylinder for the handle assembly shown in FIG. 4A. [0056] FIG. 4C is a cross-sectional view of one embodiment of the cylindrical cam cylinder shown in FIG. 4C. [0057] FIG. 4D is an end view of one embodiment of the cylindrical cam cylinder shown in FIG. 4C. [0058] FIG. 4B is an enlarged perspective view of one embodiment of the spool for the handle assembly shown in FIG. 4A. [0059] FIG. 4C is a front view of the cylindrical cam cylinder shown in FIG. 4C at a fixed position. [0060] FIG. 4C is a front view of the cylindrical cam cylinder shown in FIG. 4C when rotated in the clockwise direction and / or the counterclockwise direction by about 136.5 degrees. [0061] Fig. 4C is a front view of the cylindrical cam cylinder shown in Fig. 4C when it is rotated about 273.1 degrees in the clockwise direction. [0062] Fig. 4C is a front view of the cylindrical cam cylinder shown in Fig. 4C when it is rotated 307.6 degrees counterclockwise toward a fixed position. [0063] Includes an indication of the amount of angular rotation of the cam cutter at each position of the cylindrical cam cylinder shown in FIGS. 5A, 5B, 5C, and 5D of the cylindrical cam cylinder shown in FIG. 4E. It is an end view. [0064] FIG. 6 is a front view of one embodiment of a sheath assembly. [0065] FIG. 7 is a front view of an isolated embodiment of the distal end of the sheath assembly shown in FIG. 6; [0066] FIG. 7 is a front view of an isolated embodiment of the proximal end of the sheath assembly shown in FIG. 6; [0067] FIG. 6 is a front view of one embodiment of an outer sheath assembly. [0068] FIG. 6 is a front view of one embodiment of an inner sheath assembly. [0069] FIG. 7 is a cross-sectional view of one embodiment of the sheath assembly shown in FIG. [0070] FIG. 8A is an enlarged cross-sectional view of the distal end of the inner sheath assembly disposed within the outer sheath assembly shown in FIG. The blade is retracted and positioned within the outer sheath assembly. 8A 'is an enlarged cross-sectional view of the distal end of the inner sheath assembly disposed within the outer sheath assembly shown in FIG. The blade extends and is positioned outside the outer sheath assembly. [0072] FIG. 9 is a view of the distal end of the inner sheath assembly disposed within the outer sheath assembly shown in FIG. [0073] FIG. 9 is an enlarged cross-sectional view of the inner key of the inner sheath assembly disposed within the outer key of the outer sheath assembly shown in FIG. [0074] FIG. 13 is a perspective view of an outer band member according to an embodiment of the present disclosure. [0075] FIG. 9B is an end view of the outer band member shown in FIG. 9A. [0076] FIG. 9B is a cross-sectional view of the outer band member shown in FIG. 9A taken along line 9C-9C in FIG. 9B. [0077] FIG. 12 is a perspective view of a cutting tip according to an embodiment of the present disclosure. FIG. 10B is a side view of the cutting tip shown in FIG. 10A. [0079] FIG. 10B is an end view of the member at the cutting tip shown in FIG. 10A. [0080] FIG. 10B is a cross-sectional view of the cutting tip shown in FIG. 10A taken along line 10D-10D in FIG. 10C. [0081] A cam slot profile of the cutting tip representing the longitudinal position of the cutting tip in combination with the longitudinal position of the trigger for a specific amount of angular rotation by both the cutting tip and the cylindrical cam cylinder; It is a figure of the cam slot of a cylindrical cam cylinder. [0082] FIG. 9 is a perspective view of a human with a pacemaker lead placed in a venous system and a terminal electrode fixed to the heart chamber of the ventricle. One embodiment of a surgical device is shown inserted into the body and partially advanced over the lead. [0083] FIG. 12 is a front view of one embodiment of a surgical device. [0084] FIG. 12 is a cross-sectional view of a sheath assembly inside a blood vessel having an extensible and rotatable blade for removing a lead, according to one embodiment of the present disclosure. [0085] FIG. 14 is an internal view of one embodiment of the handle assembly of the surgical device shown in FIG. [0086] FIG. 15B is a perspective view of one embodiment of a trigger for the handle assembly shown in FIG. 15A. [0087] FIG. 15B is a front view of one embodiment of a cylindrical cam assembly for the handle assembly shown in FIG. 15A. [0088] FIG. 15C is a front view of the cylindrical cam cylinder of the cylindrical cam assembly shown in FIG. 15C. [0089] FIG. 15D is a cam slot profile view of the cam slot of the cylindrical cam cylinder shown in FIG. 15D. [0090] Fig. 15D is a longitudinal sectional view of the cylindrical cam cylinder shown in Fig. 15D. FIG. 15D is a cross-sectional view of the cylindrical cam cylinder shown in FIG. 15D. [0092] FIG. 15C is a front view of the follower guide of the cylindrical cam assembly shown in FIG. 15C. [0093] FIG. 15H is an aperture profile view of the follower guide shown in FIG. 15H. [0094] FIG. 15F is an end view of the cylindrical cam assembly of FIG. 15C showing the relative rotation blocking mechanism in a first relative rotation blocking position. [0095] FIG. 15F is an end view of the cylindrical cam assembly of FIG. 15C showing the relative rotation blocking mechanism in a second relative rotation blocking position. [0096] FIG. 15B is an enlarged perspective view of one embodiment of a spring assembly for the handle assembly shown in FIG. 15A. [0097] Fig. 12 is a front view of one embodiment of a sheath assembly. [0098] FIG. 17 is a front view of an isolated embodiment of the distal end of the sheath assembly shown in FIG. [0099] FIG. 17 is a front view of an isolated embodiment of the proximal end of the sheath assembly shown in FIG. [00100] FIG. 48 is a front view of one embodiment of an outer sheath assembly. [00101] FIG. 6 is a front view of one embodiment of an inner sheath assembly. [00102] FIG. 17 is a cross-sectional view of one embodiment of the sheath assembly shown in FIG. [00103] FIG. 18 is an enlarged cross-sectional view of the distal end of the inner sheath assembly disposed within the outer sheath assembly shown in FIG. The blade is retracted and positioned within the outer sheath assembly. 18A 'is an enlarged cross-sectional view of the distal end of the inner sheath assembly disposed within the outer sheath assembly shown in FIG. The blade extends and is positioned outside the outer sheath assembly. [00105] FIG. 19 is a view of the distal end of the inner sheath assembly disposed within the outer sheath assembly shown in FIG. [00106] FIG. 19 is an enlarged cross-sectional view of the inner key of the inner sheath assembly disposed within the outer key of the outer sheath assembly shown in FIG. [00107] FIG. 6 is a perspective view of an outer band member according to an embodiment of the present disclosure. [00108] FIG. 19B is an end view of the outer band member shown in FIG. 19A. [00109] FIG. 19B is a cross-sectional view of the outer band member shown in FIG. 19A taken along line 19C-19C of FIG. 19B. [00110] FIG. 10 is a perspective view of a cutting tip according to one embodiment of the present disclosure. [00111] FIG. 20B is a side view of the cutting tip shown in FIG. 20A. [00112] FIG. 20B is an end view of the member at the cutting tip shown in FIG. 20A. [00113] FIG. 20D is a cross-sectional view of the cutting tip shown in FIG. 20A, taken along line 20D-20D in FIG. 20C. [00114] FIG. 4 is a two-dimensional view of a cam slot profile of one embodiment of a cutting tip, a cam slot profile of one embodiment of a cylindrical cam cylinder, and an opening profile of one embodiment of a follower guide. [00115] A cam slot profile of the cutting tip that represents the longitudinal position of the cutting tip in combination with the longitudinal position of the trigger for a specific amount of angular rotation by both the cutting tip and the cylindrical cam cylinder, It is a figure of the cam slot of a cylindrical cam cylinder, and the profile of the opening of a follower guide. The follower guide is shown in the first relative rotation blocking position as compared to the cylindrical cam cylinder. [00116] The cutting slot cam slot profile representing the longitudinal position of the cutting tip combined with the longitudinal position of the trigger for a specific amount of angular rotation by both the cutting tip and the cylindrical cam cylinder FIG. 5 is another view of the profile of the cam slot of the cylindrical cam cylinder and the opening of the follower guide. The follower guide is shown in the second relative rotation blocking position as compared to the cylindrical cam cylinder. [00117] and the cutting slot cam slot representing the longitudinal position of the cutting tip in combination with the trigger longitudinal position for a specific amount of angular rotation by both the cutting tip and the cylindrical cam cylinder. FIG. 6 is another view of a profile, a cam slot of a cylindrical cam cylinder, and an opening profile of a follower guide. The follower guide is again shown in the first relative rotation blocking position compared to the cylindrical cam cylinder. [00118] FIG. 15C is a front view of the cylindrical cam assembly shown in FIG. 15C in a first home position. [00119] FIG. 15C is a front view of the cylindrical cam assembly shown in FIG. 15C when rotated away from the first home position. [00120] FIG. 15C is a front view of the cylindrical cam assembly shown in FIG. 15C when it is further away from the first fixed position. [00121] FIG. 15C is a front view of the cylindrical cam assembly shown in FIG. 15C in a second fixed position. [00122] FIG. 15C is a front view of the cylindrical cam assembly shown in FIG. 15C when rotated away from the second home position. [00123] FIG. 15C is a front view of the cylindrical cam assembly shown in FIG. 15C when it is further away from the second home position. [00124] FIG. 10 is a perspective view of one embodiment of a cylindrical cam assembly for a surgical device. [00125] FIG. 25 is an exploded perspective view of the cylindrical cam assembly of FIG. [00126] FIG. 25 is a side view of the cylindrical cam cylinder of the cylindrical cam assembly of FIG. [00127] FIG. 25 is a side view of the follower guide of the cylindrical cam assembly of FIG. [00128] FIG. 25 is another side view of the follower guide of FIG. [00129] FIG. 25 is a partial perspective view of one embodiment of a cylindrical cam assembly for a surgical device. [00130] FIG. 30 is another partial perspective view of the cylindrical cam assembly of FIG. [00131] FIG. 10 is a perspective view of one embodiment of a cylindrical cam assembly for a surgical device. The follower guide of the cylindrical cam assembly is translucent for illustration. [00132] FIG. 12 is a perspective view of one embodiment of a cylindrical cam assembly for a surgical device. The follower guide of the cylindrical cam assembly is translucent for illustration. [00133] FIG. 10 is a perspective view of one embodiment of a cylindrical cam assembly for a surgical device. Hidden features are indicated by light gray lines. [00134] FIG. 34 is another perspective view of the cylindrical cam assembly of FIG. [00135] FIG. 5 is a two-dimensional view of a cam slot profile of one embodiment of a cutting tip, a cam slot profile of one embodiment of a cylindrical cam cylinder, and an opening profile of one embodiment of a follower guide. [00136] The cam slot profile of the cutting tip representing the longitudinal position of the cutting tip in combination with the longitudinal position of the trigger for a specific amount of angular rotation by both the cutting tip and the cylindrical cam cylinder; It is a figure of the cam slot of a cylindrical cam cylinder, and the profile of the opening of a follower guide. The follower guide is shown in the first relative rotation blocking position as compared to the cylindrical cam cylinder. [00137] The cam slot profile of the cutting tip representing the longitudinal position of the cutting tip in combination with the longitudinal position of the trigger for a specific amount of angular rotation by both the cutting tip and the cylindrical cam cylinder; It is another figure of the cam slot of a cylindrical cam cylinder, and the profile of the opening of a follower guide. The follower guide is shown in the second relative rotation prohibition position as compared with the cylindrical cam cylinder. [00138] The cam slot profile of the cutting tip representing the longitudinal position of the cutting tip in combination with the longitudinal position of the trigger for a specific amount of angular rotation by both the cutting tip and the cylindrical cam cylinder; It is another figure of the cam slot of a cylindrical cam cylinder, and the profile of the opening of a follower guide. The follower guide is again shown in the first relative rotation blocking position compared to the cylindrical cam cylinder. [00139] FIG. 6 is a two-dimensional view of a cam slot profile of one embodiment of a cylindrical cam cylinder. [00140] FIG. 10 is a front view of one embodiment of a distal end of a sheath assembly. [00141] FIG. 39 is an enlarged cross-sectional view of the distal end of the sheath assembly of FIG. 38 including an inner sheath assembly disposed within the illustrated outer sheath assembly. The blade is retracted and positioned within the outer sheath assembly. [00142] FIG. 39B is a front view of an isolated embodiment of the distal end of the sheath assembly shown in FIGS. 38 and 38A. [00143] FIG. 10 is a front view of one embodiment of the distal end of the outer sheath assembly. [00144] FIG. 41 is an enlarged cross-sectional view of the distal end of the outer sheath assembly of FIG. [00145] FIG. 48 is a front view of one embodiment of the distal end of the inner sheath assembly. [00146] FIG. 42 is an enlarged cross-sectional view of the distal end of the inner sheath assembly of FIG. [00147] FIG. 6 is a front view of a hypotube used as an outer sheath. [00148] FIG. 43 is a cross-sectional view of the hypotube obtained along line AA of FIG. [00149] FIG. 43 is an enlarged view of the hypotube segment obtained with respect to circle B of FIG. [00150] FIG. 5 is a front view of a hypotube used as an inner sheath. [00151] FIG. 44 is a cross-sectional view of the hypotube obtained along line AA of FIG. [00152] FIG. 44 is an enlarged view of the hypotube segment obtained with respect to circle B of FIG. [00153] FIG. 44 is an enlarged view of the hypotube of FIG. 42 and / or the hypotube of FIG. [00154] FIG. 6 is a block diagram illustrating the axial alignment of the segments of the outer sheath (outer hypotube) relative to the inner sheath (inner hypotube). [00155] FIG. 6 is an alternative block diagram representing the axial alignment of the segments of the outer sheath (outer hypotube) relative to the inner sheath (inner hypotube). [00156] FIG. 6 is another alternative block diagram representing the axial alignment of the segments of the outer sheath (outer hypotube) relative to the inner sheath (inner hypotube). [00157] FIG. 12 is a further alternative block diagram representing the axial alignment of the segments of the outer sheath (outer hypotube) relative to the inner sheath (inner hypotube).

  [00158] It should be understood that these drawings are not necessarily to scale. In certain instances, details that are not necessary for understanding the present disclosure or that make it difficult to notice other details have been omitted. Of course, it is to be understood that this disclosure is not necessarily limited to the specific embodiments illustrated herein.

  [00159] Before describing any embodiment of the present disclosure in detail, the present disclosure, in its application, will be disclosed in the following description or illustrated in the following drawings with structural details and component features. It should be understood that the present invention is not limited to the above. The present disclosure is capable of other embodiments and may be practiced or carried out in various ways. It should be understood that the language and terminology used herein is for the purpose of description and should not be considered limiting. As used herein, the use of “comprising”, “including”, or “having” and its endings means including the item listed thereafter and equivalents, as well as additional items.

  [00160] A sheath assembly included in a surgical device provided by embodiments according to the present disclosure can be safely placed within a patient's vasculature to remove an implant such as a lead from the patient's vasculature. To separate. FIG. 1 represents a surgical device 106 in which a sheath assembly 112 has been inserted into an exemplary patient 104. The sheath assembly 112 surrounds an implanted lead (not shown), passes along the left brachiocephalic vein, passes through the SVC, and is connected into or around the right ventricle of the heart. When a user of the surgical device 106 surrounds the lead with the sheath assembly 112, the handle assembly 108 is actuated to expand, separate, and / or cut tissue surrounding the lead in the patient's SVC. First, a cutting blade (not shown) is extended beyond the distal end of the sheath assembly 112 while rotating.

  [00161] When the handle assembly is actuated, the cutting blade extends and retracts into the sheath multiple times according to the cam slot profile of the cutting tip disclosed below. The cutting blade rotates in both clockwise and counterclockwise directions according to the cam slot profile of the cylindrical cam cylinder discussed below. When the clinician releases the handle assembly, the cutting blade is guaranteed to remain inside or return to the sheath assembly 112 so that the clinician can move the sheath assembly away from further uncut tissue. It is possible to proceed by pressing the place. As the clinician repeats the actuation steps, the cutting blade reappears and extends beyond the distal end of the sheath assembly 112 to cut adjacent tissue. Each time actuation occurs, the proximal portion of the implanted lead and / or surrounding tissue further enters a hollow passage within the sheath assembly 112. This process is repeated again until the implanted lead and / or surrounding tissue is completely or substantially expanded, separated, and / or cut from tissue attached to the SVC. The implanted lead is then safely removed from the patient's SVC.

  [00162] Referring to FIG. 2, an exemplary surgical device 106 is illustrated. Surgical device 106 includes a handle assembly 108 and a flexible sheath assembly 112. The flexible sheath assembly 112 is discussed in more detail below and generally includes a flexible inner sheath assembly (not shown) disposed within the flexible outer sheath assembly. Desirably, the inner sheath can move (eg, rotate and extend) relative to the outer sheath while the outer sheath remains stationary. Both the inner and outer sheaths can be flexible, rigid, or a combination thereof.

  [00163] Referring to FIG. 4A, an exemplary handle assembly is depicted. Handle assembly 108 includes some or all of the following components: handle frame 404, trigger 408, spring assembly 412, strain relief component 416, cylindrical cam cylinder 420, bushing 424, and end cap 427. The handle frame 404 is constructed from a single part or multiple parts, such as two halves as shown in FIG. 4A.

  [00164] Referring to FIG. 4B, an example trigger 408 is shown. The trigger 408 depicted in FIG. 4A includes one opening 430 through which a clinician's finger can be inserted. However, the trigger may have multiple openings. In addition, the trigger may consist of a straight or non-linear member without an opening. In addition, the trigger may be in the form of a button that can be depressed. As long as the trigger is ergonomically appropriate and comfortable for the clinician, alone or with the handle frame, the trigger may have various sizes and shapes.

  [00165] The trigger 408 shown in FIG. 4B includes a trigger pin 428 extending vertically from the top of the trigger 408. FIG. The trigger pin 428 is formed from a metal, such as a copper alloy (eg, brass or bronze, particularly C630 nickel aluminum bronze), and includes a termination that is shaped like a truncated cone to facilitate insertion into the handle frame 404. The trigger pin 428 cooperates with the groove of the cylindrical cam cylinder 420 and functions as a follower of the cylindrical cam. The trigger 408 also includes a pair of sliders 432 that project horizontally from the proximal end of the trigger 408 and a pair of sliders 436 that project horizontally from the distal end of the trigger 408. When the trigger 408 is disposed within the handle assembly 108, the sliders 432, 436 are in corresponding grooves within the handle frame 404 and slide therein. The trigger 408 also includes a post 440 extending vertically from the top of the trigger 408 (preferably from the distal end of the top of the trigger 408). Post 440 connects to spring assembly 412.

  [00166] The handle assembly 108, including the trigger 408 and the cylindrical cam cylinder 420 discussed above, is an example of a mechanical actuation means for rotating the inner sheath assembly. In an alternative embodiment, the actuating means comprises an electromechanical component. For example, the driven shaft of an electric motor (not shown) included in the actuation means is coupled directly or indirectly to the inner sheath, cylindrical cam cylinder, trigger pin, and / or any combination thereof. The motor shaft is indirectly coupled to the inner sheath by one or more of the tools discussed above. The motor is controlled by a switch, which causes the inner sheath to rotate in a clockwise and / or counterclockwise direction when a switch that also acts as a trigger is activated. The electric motor is either a direct current (DC) motor or an alternating current (AC) motor. Therefore, the motor is powered by a DC power source such as a battery or an AC power source such as a conventional power cord. In addition, those skilled in the art will appreciate that there are many other ways to actuate and drive a surgical device with a rotatable sheath.

  [00167] As described above, the handle assembly 108 includes a strain relief component 416. The strain relief component 416 is attached to the distal end of the handle frame 404 as shown in FIG. 4A and tapers from the proximal end toward the distal end. The strain relief component 416 also has a lumen therethrough, which allows the sheath assembly 112 to extend through the lumen and into the handle assembly 108. The strain relief component 416 is constructed from a flexible material such as Santoprene ™ thermoplastic vulcanizate produced by ExxonMobil. The material of the strain relief component and the shape of the strain relief component provide a flexural modulus to protect the flexible shaft as it extends into the rigid handle. The lumen of the strain relief component also includes a counterbore that allows the auxiliary outer sheath to be merged during device preparation.

  [00168] Referring to FIGS. 4C, 4D, and 4E, a front view, a cross-sectional view, and an end view of the cylindrical cam cylinder 420 are shown, respectively. As shown in FIGS. 4C and 4D, the cylindrical cam cylinder 420 has an outer surface with a cam slot (or channel) 444 that cooperates with the trigger pin 428 to provide a cylindrical cam. Cam slot 444 provides a two-dimensional linear cam profile and / or non-linear cam profile, discussed in more detail below. A lumen 456 extends through the proximal end 448 and the distal end 452 of the tubular cam cylinder 420.

  [00169] FIG. 4E shows an end view of the distal end 452 of the cylindrical cam cylinder 420. FIG. The distal end 452 of the lumen 456 of the cylindrical cam cylinder 420 is designed to coincide with the exterior of the proximal end of the inner key 612, which will be discussed in more detail below. The cross-section of the distal end 452 of the lumen 456 of the cylindrical cam cylinder 420 is preferably non-circular. For example, one embodiment of a non-circular lumen includes two chamfered side surfaces 464, one of the chamfered side surfaces 464 is not offset and the other of the chamfered side surfaces 464 is (eg, about 8 degrees). It is offset. The distal end of the tubular cam cylinder 420 coincides with the exterior of the proximal end of the inner key 612 to transmit torque from the tubular cam cylinder 420 to the inner sheath assembly via the inner key 612. As designed, the outer cross-section of the proximal end of the inner key 612 will have a complementary profile of the lumen 456. Although the cross-sectional shape of a non-circular lumen has been described as having two chamfered side surfaces 464, the present disclosure is not limited to such a shape, and is square, rectangular, D-shaped, triangular, diamond-shaped , Trapezoids, pentagons, hexagons, octagons, parallelograms, ellipses, and other non-circular shapes. Alternatively, the inner key can be coupled to the outside of the cylindrical cam cylinder.

  [00170] The proximal end of the cylindrical cam cylinder 420 coincides with the bushing 424. Specifically, the outer distal end of bushing 424 is disposed within the proximal end of lumen 456. Both the outer distal end of the bushing 424 and the proximal end of the lumen 456 are circularly shaped so that the bushing 424 and the cylindrical cam cylinder 420 can rotate relative to each other. However, the outer proximal end of the bushing 424 is disposed within a groove inside the handle frame 404 so that the bushing 424 and the cylindrical cam cylinder 420 move longitudinally within the handle assembly 108. To prevent.

  [00171] Referring to FIG. 4F, an exemplary spring assembly 412 is depicted. The spring assembly 412 includes a constant load spring 472 and a spool 474. One end of the constant load spring 472 is connected to the spool 474, and the other end of the constant load spring 472 is connected to a post 440 extending from the trigger 408. As the clinician pulls the trigger 408 proximally, the sliders 432, 436 slide through the grooves in the handle frame 404, thereby causing the trigger 408 to move vertically into the handle assembly 108. Preventing and allowing movement along the longitudinal axis of the surgical device 106 only from the distal end to the proximal end and / or vice versa. As trigger 408 moves proximally, constant load spring 472 extends, thereby creating tension and distal force. Therefore, when the clinician releases the trigger 408, the constant load spring 472 contracts, pulling the trigger 408 back to its original, most distal position.

  [00172] Referring to FIG. 6, a front view of one embodiment of the assembled sheath assembly 112 of the present disclosure is depicted. The sheath assembly 112 includes an inner sheath assembly and an outer sheath assembly. Referring to FIG. 6A, an exploded view of the distal end of the sheath assembly 112 is shown, FIG. 6B is an exploded view of the proximal end and center of the sheath assembly 112, and the sheath assembly 112 is Some of the parts such as band 636, guide pin 640, cutting tip 632, flexible inner sheath 620, flexible outer sheath 624, outer jacket 628, inner key 612, outer key 608, and rigid inner tube 616 Or include everything.

  [00173] Referring to FIG. 7A, one embodiment of an outer sheath assembly 602 of the present disclosure is illustrated. The outer sheath assembly 602 includes an outer band 636 disposed and attached to the distal end of the elongate flexible outer sheath 624 and an outer key 608 disposed and attached to the proximal end of the flexible outer sheath 624. Including. The outer band 636 is attached to the distal end of the flexible outer sheath 624 by means of an interlock or other known attachment means such as welding, adhesives, press fit techniques, bamboo shoot fittings. All such attachment techniques within the knowledge of those skilled in the art are considered to be within the scope of this disclosure. Similarly, the outer key 608 is attached to the proximal end of the flexible outer sheath 624 by means of an interlock or other known attachment means such as welding, adhesives, press-fit techniques, bamboo shoot fittings. Although not shown in FIG. 7A, the outer sheath assembly also includes a flexible outer jacket 628 that covers the outer sheath 624 and contacts the outer band 636, thereby providing a relatively smooth, continuous, uninterrupted exterior. An outer sheath assembly having a profile is provided. The flexible jacket also includes a blood outlet from the system.

  [00174] Referring to FIG. 7B, one embodiment of an inner sheath assembly 604 of the present disclosure is illustrated. Inner sheath assembly 604 includes a cutting tip 632, a flexible inner sheath 620, an inner key 612, and a rigid inner tube 616. The proximal end of the cutting tip 632 is attached to the distal end of the flexible inner sheath 620, and the distal end of the inner tube 616 is attached to the proximal end of the flexible inner sheath 620, Key 612 is attached to the proximal end of inner tube 616. Means for attaching these parts include welding, adhesives, press fit techniques or other known means of attachment. As discussed below, the guide pin 640 couples the outer band 636 with the cutting tip 632, and the guide pin 640 is included in either the inner sheath assembly 604 or the outer sheath assembly 602.

  [00175] Preferably, a portion of either the inner sheath 620 and / or the outer sheath 624 is rigid and a portion of the outer sheath is flexible. Both the rigid and flexible portions are constructed from materials suitable for insertion into the human body. For example, the rigid portion is constructed from stainless steel and the flexible portion is constructed from a plastic polymer such as polytetrafluoroethylene or a thermoplastic elastomer. Assuming that both rigid and flexible portions are used, these will form a unitary inner and / or outer sheath. As shown in FIG. 7B, the rigid inner tube 616 is not only attached to the inner key 612 but also inserted through the inner key 612 and from both the proximal and distal ends of the inner key 612. Elongate. The rigid tube 616 can be attached to and extend from the inner key 612 to increase the amount of torque that can be transmitted from the cylindrical cam to the rigid tube 616 via the inner key 612, eventually The amount of torque that can be transmitted to the cutting tip 632 via the sheath assembly 604 can be increased. The rigid tube extends through the handle, providing an access point for introducing other medical devices. This stretching also provides a means of controlling the blood outlet after the lead has been withdrawn.

  [00176] It is desirable that at least a portion of the outer sheath 624 and the inner sheath 620 be generally flexible to receive, contain and advance the patient's vasculature. In addition to being flexible, the inner sheath 620 receives torque transmitted from the cylindrical cam cylinder / inner key and transmits sufficient torque to the cutting tip 632, discussed in more detail below. In addition, it has high rigidity. Inner sheath 620 (and / or outer sheath 624) is formed from polymer extrusion, mesh reinforced polymer extrusion, coil, double coil, triple coil, laser cut metal tube and any combination thereof. The inner sheath (and / or outer sheath 624) is a multi-part integrated structure.

  [00177] Referring to FIG. 8, a cross-sectional view of one embodiment of a sheath assembly 112 comprising an inner sheath assembly 604 disposed within an outer sheath assembly 602 is depicted. Referring to FIG. 8C, an enlarged view of the inner key 612 of the inner sheath assembly 604 disposed within the outer key 608 of the outer sheath assembly 602 is shown. As discussed above, the exterior of the inner key 612 is designed to coincide with the lumen 456 at the distal end of the cylindrical cam cylinder 420. Thus, the outer cross-section of the proximal end of the inner key 612 will have a complementary profile with respect to the distal end of the lumen 456 inside the cylindrical cam cylinder 420. For example, the distal end 452 of the lumen 456 of the cylindrical cam cylinder 420 is non-circular and has two chamfered sides, one of the chamfered sides is not offset and the other is chamfered. Assuming that the sides are offset (eg, about 8 degrees), the exterior of the proximal end of the inner key 612 also has a non-circular profile with two chamfered sides, where one chamfered side is Without offset, the other chamfered side will be offset (eg, about 8 degrees). Inner key 612 and outer key 608 provide a means for rotationally coupling. The inner key 612 is a means for rotationally coupling the inner sheath assembly 604 to the cylindrical cam, and the outer key is a means for rotationally coupling the outer shaft assembly to the handle. is there. Inner key 612 and outer key 608 provide journal bearings for other keys.

  [00178] As further shown in FIG. 8C, the inner key 612 has a circular cross section in which the outer distal end of the inner key 612 matches the circular cross section of the proximal end of the inner lumen of the outer key 608. At least partially so that it can rotate freely within the outer key 608. In addition, because the inner key 612 and the outer key 608 are softly coupled, the inner key 612 and the outer key 608 can move longitudinally relative to each other. For example, assuming the outer key 608 is fixed so that it does not rotate or move longitudinally, the inner key 612 can rotate within the outer key 608 and advance longitudinally. You can also. Therefore, when the cylindrical cam cylinder 420 rotates, the inner key 612 will rotate inside the outer key 608 and the inner sheath assembly 604 will include rotation of the cutting tip 632 inside the outer band 636. Thus, the outer sheath assembly 602 rotates. Also, the cam slot profile of the cutting tip 632 includes the longitudinal movement of the inner key 612 relative to the outer key 608 and the longitudinal movement of the cutting tip 632 relative to the outer band 636 of the outer sheath assembly 602. Controls the longitudinal movement of the inner inner sheath assembly 604.

  [00179] With continued reference to FIG. 8C, the lumen inside the outer key 608 has a step-down or abutment as it proceeds from the proximal end to the distal end, so that the lumen is directed toward the proximal end. Increases and decreases toward the distal end. Because there is a transition from a large lumen to a small lumen within the outer key 608, the distal end of the larger lumen of the outer key 608 is located between the distal end of the inner key 612 and the abutment. An adjustable gap 610 is shown. This gap increases, decreases and / or remains the same according to the cam slot profile of the cutting tip 632. The abutment of the outer key 608 ensures that the inner key 612 advances only a limited longitudinal distance inside the outer key 608, thereby moving the cutting tip 632 distal to the outer band 636. Limiting the possible longitudinal movement of the inner sheath assembly 604 within the outer sheath assembly 602, including restricting the longitudinal movement of the inner sheath assembly 604.

  [00180] Referring to FIG. 8A, an enlarged cross-sectional view of the distal end of the sheath assembly 112 having an inner sheath assembly 604 coupled to the outer sheath assembly 602 via a guide pin 640 is shown. The blade 822 of the tip 632 is in the retracted position and is disposed inside the outer sheath assembly 602. As discussed above, the outer band 636 included at the distal end of the outer sheath assembly 602 is constructed from a biocompatible metal, such as stainless steel, and is polished smoothly throughout, with its most distal Uniformly rounded at the point so that it can act as a dilator when pressed against the tissue. The distal end 822 of the cutting tip 632 includes a cutting surface that can cut tissue. The inner sheath assembly 604 is coupled to the outer sheath assembly 602 via a guide pin 640 by a cutting tip 632 and an outer band 636, respectively. One end of the guide pin 640 is fixed inside the outer band 636, and the other end of the guide pin 640 is disposed inside the cam slot 814 of the cutting tip 632. As the inner sheath 620 rotates, the inner sheath 620 is fixedly attached to the cutting tip 632 so that upon operation of the trigger assembly discussed above, the cutting tip 632 also rotates. As the cutting tip 632 rotates, the cutting tip 632 also extends distally in the direction of the arrow (→) as represented in FIG. 8A ′ according to the profile of the cam slot 814. As the cutting tip 632 extends distally and rotates, the guide pin 640 and the outer sheath assembly 602, particularly the outer band 636, remain stationary. Thus, when the cutting tip 632 extends distally (possibly retracts proximally according to the cam slot profile) and rotates, the cutting surface at the distal end 822 of the cutting tip 632 is relative to the tissue. The tissue can be cut by performing a cutting action.

  [00181] Further, FIG. 8A depicts the cutting tip 632 in a retracted (possibly inactive) position because the cutting tip 632 is in a proximal position. In other words, the distal end 822 of the cutting tip 632 of FIG. 8A is disposed within the outer sheath assembly 602, particularly the outer band 636, and extends beyond the distal end of the outer band 636. There is no. Referring to FIG. 8A ', the cutting tip 632 is shown in an extended (and actuated) position as it extends beyond the distal end of the outer sheath assembly 602 and the outer band 636.

  [00182] FIG. 3 depicts the distal portion of the flexible outer sheath and flexible inner sheath of FIG. 8A surrounding the lead 330 inside the patient's vein 334, with the cutting tip 632 in the extended position. . Due to the surrounding nature of the cutting surface at the distal end of the cutting tip 632 (eg, a knurled blade), the surgical device acts as a coring device, whereby the tissue 338 around the lead or implant being extracted. Are cut partially (ie, less than 360 degrees) or completely (ie, 360 degrees). The amount of tissue that the cutting surface cuts depends on the size, shape and configuration of the leads and the diameter and thickness of the circular cutting blade. For example, if the diameter of the circular cutting surface is substantially larger than the diameter of the lead, this cutting surface will cut and decenter more tissue compared to a cutting surface with a smaller diameter. become. Once the desired cut is made, the operator releases the trigger and the cutting tip 632 (including the cutting surface) returns to the retracted position. When the cutting surface returns to the retracted position, the distal tip of the outer band 636 (and / or other part of the outer sheath assembly) acts safely as an expansion device so that the outer sheath assembly can be withdrawn. When moving over the implant, spread the tissue.

  [00183] With full gripping of each of the triggers, the cutting tip (and inner sheath) will rotate clockwise / counterclockwise while extending / retracting. When the trigger is released after full clamping and is fully compressed and / or remains retracted, the cutting tip (and inner sheath) retracts into the outer sheath tip. . The trigger does not reset when partially squeezed, and when the trigger is released, the movement of the cutting tip (and inner sheath) will be reversed, returning the blade to the retracted position. Returning to the fully returned trigger position results in a rotation of approximately 35 degrees due to the profile at the distal cam, keeping the cut in the retracted position.

  [00184] Although the inner sheath and outer sheath are coupled to each other via a cutting tip, an outer band and a guide pin, the inner sheath assembly and the outer sheath assembly may be coupled to each other in other ways. In other words, after understanding the present disclosure for joining the sheath in a manner that allows the cutting surface to extend and rotate beyond the distal end of the outer sheath, those skilled in the art will be disclosed. It should be understood how to make and use the various aspects, embodiments, and / or configurations. All such configurations within the purview of those skilled in the art are considered to be within the scope of this disclosure.

  [00185] Referring to FIGS. 9A, 9B, and 9C, an example outer band 636 is illustrated. The outer band 636 is a generally cylindrical sleeve of a hollow cylinder. The exterior of the outer band 636 is non-uniform, but the hollow cylinder can be uniform. The inside of the outer band 636 is not uniform. For example, within the outer band 636, a cutting tip (not shown in FIGS. 9A, 9B, and 9C) advances further from the proximal end 912 to the distal end 908 inside the outer band 636. An abutment 916 for preventing is included. Outer band 636 also includes a hole 904 for receiving and possible attachment of a radially inwardly projecting guide pin (not shown in FIGS. 9A, 9B and 9C). As discussed in more detail above, the guide pin engages the cam slot of the cutting tip. The size, shape and configuration of the outer band 636 can vary depending on how it is attached to the flexible outer sheath. As discussed above, the outer sheath is stationary. If so, the outer band 636 and the guide pin remain stationary as the cutting tip moves (eg, rotates and travels longitudinally) relative to them. The outer band also includes a journal bearing surface for aligning the cutting blade during operation and providing a surface that separates tissue as the cutting blade retracts into the interior of the device.

  [00186] Referring to FIGS. 10A, 10B, 10C, and 10D, an exemplary cutting tip 632 is illustrated. The cutting tip 632 has a hollow cylindrical shape as a whole. Cutting tip 632 includes a proximal portion 1024, an intermediate portion 1028, and a distal portion 1032. The outer diameter of the proximal portion 1024 is determined by insertion and / or engagement of the proximal portion 1024 with respect to the inner diameter of the inner flexible sheath (not shown in FIGS. 10A, 10B, 10C, and 10D). Otherwise, the size is such that installation is possible. The distal end of the cutting tip 632 includes a cutting surface 1012 having a serrated sharp blade profile. Inside the outer surface of the intermediate portion 1028 is provided a cut channel (or cam slot) 1016. As the inner flexible sheath rotates within the outer sheath, from the proximal end to the distal end, the outer sheath and pin remain stationary. If so, an inner sheath (not shown) connected to the cutting tip 632 forces the cutting tip 632 to rotate. The cam slot 1016 engages the guide pin, and the shape and profile of the cam slot 1016 controls the speed and distance that the cutting tip 632 advances in the longitudinal direction. That is, the configuration of the cam slot 1016 controls the direction and amount of longitudinal progression, such as distal movement of the cutting tip toward the extended position and / or proximal movement toward the retracted position, The cutting tip 632 rotates either in a clockwise direction or in a counterclockwise direction.

  [00187] Referring again to FIGS. 10A, 10B, 10C, and 10D, the cutting tip 632 also includes a step-up 1020 such that the diameter of the intermediate portion 1028 is greater than the distal portion 1032. As the cutting tip 632 rotates and the cutting surface 1012 extends beyond the distal end of the outer band to the extended position, the step-up 1020 of the cutting tip 632 contacts the abutment of the outer band, thereby Even when the pin is sheared, it limits the distance traveled by the cutting tip 632 and / or the cutting tip 632 exits or extends beyond the distal tip of the outer sheath assembly, particularly the outer band. To prevent.

  [00188] The profile of the cutting slot cam slot is disclosed in US patent application Ser. No. 13 / 834,405 entitled “Retractable Blade For Lead Removable Device” filed on Mar. 15, 2013. The entire patent application is hereby incorporated herein by reference for all of its teachings and purposes. For example, the cam slot has a substantially linear profile, a substantially sinusoidal profile, or an individual combination and / or a combination of linear and non-linear profiles. In addition, the cam slot may have an open continuous configuration to allow the cutting tip to rotate continuously or when the cutting tip reaches a fully extended position. The cam slot has a closed and discontinuous configuration so that the trigger tip must be released or flipped so that the cutting tip is actuated again after returning to its original retracted position. Also good. For example, the cam slot 1016 in FIG. 10A is discontinuous because it does not go around the entire circumference outside the cutting tip 632. Although certain figures of this disclosure show only one of an open cam slot configuration or a closed cam slot configuration, either configuration is the inner cam disclosed and / or discussed herein. Can be used with any of these embodiments and are considered within the scope of this disclosure. In addition, a partial lobe cam (including a cam slot that surrounds the outer surface of the cutting tip by less than 360 degrees), a single lobe cam (a cam slot that surrounds the outer surface of the cutting tip by 360 degrees). Various types of cams are possible, including double-lobe cams (including cam slots that surround the outer surface of the cutting tip 720 degrees) and / or other multi-lobe cams.

  [00189] The distal end of the cutting tip 632 is disclosed in US patent application Ser. No. 13 / 834,405 entitled “Retractable Blade For Lead Removable Device” filed Mar. 15, 2013. The entire patent application is hereby incorporated herein by reference in its entirety for all of its teachings and purposes. For example, the plane of the cutting surface 1012 at the distal end of the cutting tip shown in the figures of this disclosure is parallel to the plane of the proximal end of the cutting tip. However, the plane of the cutting surface may be offset (0 degrees to 90 degrees) from the plane of the proximal end of the cutting tip. Also, as discussed above, the profile of the cutting surface 1012 of FIGS. 10A-10D has a plurality of serrations. The profile of the cutting surface 1012 need not be serrated, and may comprise other configurations, such as a constant profile and / or a profile combining smooth and sharp portions. The profile of the cutting surface 1012 of FIGS. 10A-10D has six serrations (saw blades). However, it may be desirable to have fewer than six serrations or more than six serrations. It is also desirable to have a number of serrations between 5 and 7, a number of serrations between 4 and 8, or a number of serrations between 6 and 10.

  [00190] Although the cutting surface 1012 shows a certain number of serrations, FIGS. 10A-10D are not intended to represent the only number and type of serrations included in the saw-shaped cutting surface. Those skilled in the art, after understanding the present disclosure for adjusting the number, size, and configuration of serrations, rely on the size of the surgical device, including the sheath and cutting tip, to disclose the disclosed aspects, embodiments, and One will understand how to make and / or use a configuration. All such configurations within the purview of those skilled in the art are considered to be within the scope of this disclosure. In addition, serrations include, but are not limited to, squares, rectangles, rhombuses, parallelograms, trapezoids, triangles, circles, ellipses, folds, etc. and any number of different shapes and configurations.

  [00191] As discussed above, FIGS. 10A, 10B, and 10D represent an intermediate portion 1028 of a cutting tip 632 having a cam slot (or channel) 1016 cut into its outer surface, 4C and 4D represent a cylindrical cam cylinder 420 having a channel (or cam slot) 444 that provides a non-linear cam profile on its outer surface. Referring to FIG. 11, a two-dimensional view of the profile of the cam slot 1016 for the cutting tip 632 is shown in the upper part of the figure, and the profile of the cam slot 444 for the cylindrical cam cylinder 420 is shown in the lower part of the figure. A two-dimensional diagram is represented. The horizontal axis, which is the same for the upper and lower figures, is the rotation (degree) of the cutting tip 632 and the cylindrical cam cylinder 420. For example, as shown in FIG. 10A, when the profile of the cam slot 1016 of the cutting tip 632 is discontinuous, the rotation of the cutting tip 632 is less than 360 degrees. The rotation of the cutting tip 632 is between 5 and 355 degrees, between 180 and 355 degrees, between 210 and 325 degrees, between 240 and 295 degrees, or between 270 and 275 degrees. Between is desirable. The rotation of the cutting tip 632 is approximately 180 degrees, 185 degrees, 190 degrees, 200 degrees, 205 degrees, 210 degrees, 215 degrees, 220 degrees, 225 degrees, 230 degrees, 235 degrees, 240 degrees, 245 degrees, 250 Degrees, 255 degrees, 260 degrees, 265 degrees, 270 degrees, 275 degrees, 280 degrees, 285 degrees, 290 degrees, 300 degrees, 305 degrees, 310 degrees, 315 degrees, 320 degrees, 325 degrees, 330 degrees, 335 degrees, 340 degrees, 345 degrees, 350 degrees or 355 degrees are also desirable. The pull of the first half triggers about 273 degrees clockwise viewing the tip from the handle, thereby returning the cam blade to the retracted position. The latter trigger pull results in a rotation of about 273 degrees counterclockwise when looking at the tip from the handle, thereby returning the cutting blade back to the retracted position. The blade remains in the retracted position for a complete return to the previous position of the trigger. The vertical axis in the upper diagram is the amount of movement of the cutting tip 632 in the longitudinal direction including the cutting surface, if any. The vertical axis in the lower figure is the amount of displacement (in inches) in the longitudinal direction of the trigger assembly (and trigger pin).

[00192] Referring to FIG. 11 in combination with FIGS. 5A-5E, the following discussion is based on the rotation of the cylindrical cam cylinder 420, the rotation of the cutting tip 632, and the position of the handle (its trigger pin 428). The interaction between the longitudinal movement and the longitudinal movement of the cutting tip 632 is described. The following is a description of the positions CT1 to CT6 of the guide pin 640 inside the cam slot of the cutting tip 632.
CT1-guide pin 640 is in a fixed position inside cam slot 1016 of cutting tip 632, and cutting tip 632 is in a retracted position inside outer sheath assembly 602 (including outer band 636).
CT2—Cutting tip 632 is in the most extended position outside the outer sheath assembly 602 after approximately half of a predetermined clockwise rotation relative to the guide pin 640 inside the cam slot 1016.
CT3—Cutting tip 632 has completed a clockwise rotation relative to guide pin 640 inside cam slot 1016 and is in a retracted position inside outer sheath assembly 602.
CT4—Cutting tip 632 is in the most extended position outside the outer sheath assembly 602 after approximately half of the predetermined counterclockwise rotation relative to the guide pin 640 inside the cam slot 1016.
CT5 (not shown) —The cutting tip 632 has completed a counterclockwise rotation relative to the guide pin 640 inside the cam slot 1016 and is in a retracted position inside the outer sheath assembly 602.
CT6—Cutting tip 632 has completed counterclockwise rotation with respect to guide pin 640 within cam slot 1016 and is in the most retracted position within outer sheath assembly 602.

[00193] Positions CT1 to CT6 of the guide pin 640 inside the cam slot of the cutting tip 632 correspond to positions BC1 to BC6 of the trigger pin 428 inside the cam slot of the cylindrical cam cylinder 420. The following is a description of the positions BC1 to BC6 of the trigger pin 428 inside the cam slot of the cylindrical cam cylinder 420.
BC1—Trigger pin 428 is in place within cam slot 444 of cylindrical cam cylinder 420 (along with trigger 408 of trigger assembly 106).
The BC2-trigger pin 428 has been moved longitudinally in the proximal direction, thereby rotating the cylindrical cam cylinder 420 in the clockwise direction. At this point, the cylindrical cam cylinder has completed about half of the predetermined amount of clockwise rotation.
The BC3-trigger pin 428 has completed approximately half of its longitudinal movement and continues to move longitudinally in the proximal direction, and the cylindrical cam cylinder 420 has completed its clockwise rotation.
BC4-Trigger pin 428 has moved longitudinally in the proximal direction, thereby causing cylindrical cam cylinder 420 to rotate in a counterclockwise direction. At this point, the cylindrical cam cylinder has completed about half of the predetermined amount of counterclockwise rotation.
The BC5-trigger pin 428 has completed almost all of its longitudinal movement in the proximal direction, and the cylindrical cam cylinder 420 has completed its counterclockwise rotation.
The BC6-trigger pin 428 has been moved longitudinally in the distal direction, thereby causing the cylindrical cam cylinder 420 to rotate in the counterclockwise direction by some remaining amount.

  [00194] With continued reference to FIGS. 11 and 5A-5E, when the trigger assembly 106, particularly the trigger 408, is in its initial distal position, the trigger pin 428 is in its home position (BC1). Referring to the upper diagram of FIG. 11, when the trigger pin 428 is in its home position (BC1), the guide pin 640 of the sheath assembly 112 is in its initial position (CT1) and the cutting tip 632 is in the outer sheath assembly. It is in a retracted (or retracted) position inside the solid 602. When the clinician pulls trigger 408 to move trigger pin 428 proximally, both cylindrical cam cylinder 420 and cutting tip 632 are rotated clockwise (as viewed from the proximal perspective of the cylindrical cam cylinder). Rotate in the direction. When the cutting tip 632 rotates from position CT1 to CT2 adjacent to the guide pin 640, the cutting tip 632 follows the cam slot profile in the cutting tip 632 from the retracted position to the extended position in the distal direction. In the longitudinal direction. When the trigger pin 428 is in position BC2, (i) the cylindrical cam cylinder 420 and the cutting tip 632 are rotating about half of their predetermined allowable rotation in the clockwise direction; (ii) the guide pin 640 is at position CT2, and (iii) the cutting tip 632 is in the most extended position.

  [00195] As the clinician continues to pull the trigger, the trigger pin 428 continues to move proximally and the cylindrical cam cylinder 420 and cutting tip 632 continue to rotate in the clockwise direction. Specifically, the cutting tip 632 rotates adjacent to the guide pin 640, and the cutting tip 632 is moved to CT3, which is a retracted position from CT2, which is the extended position, according to the cam slot profile of the cutting tip 632. Move in the longitudinal direction. When the trigger pin 428 is in position BC3, (i) the cylindrical cam cylinder 420 and the cutting tip 632 are rotating about half of their predetermined allowable rotation in the clockwise direction, and (ii) the guide The pin 640 is in position CT3 and (iii) the cutting tip 632 is in a retracted position inside the outer sheath assembly 602 (including the outer band 636).

  [00196] Referring to the upper diagram of FIG. 11, the cam slot of cutting tip 632 extends beyond position CT3. As discussed above, both the inner and outer sheath assemblies are flexible. To accommodate for additional lengths that may be provided by the flexibility of the sheath assembly, as well as to accommodate manufacturing tolerances, the cam slot 1016 of the cutting tip 632 defines the position CT3. Extend beyond. For example, if the home position of the guide pin 640 is slightly to the right of the position CT1 during use of the surgical device, rather than the exact position CT1, the length of the cam slot will increase the guide pin 640. Can proceed to the right of position CT3, so that the cutting tip can rotate in a clockwise direction without disturbing the total amount of its allowable rotation.

  [00197] When the trigger pin 428 moves from the position BC1 to BC3 in the cylindrical cam cylinder 420 and the cylindrical cam cylinder 420 rotates in the clockwise direction, the trigger pin 428 is positioned inside the cam slot 444 of the cylindrical cam cylinder 420. Move along the edges of However, when the trigger pin 428 moves from the position BC3 to BC5 in the cylindrical cam cylinder and the cylindrical cam cylinder 420 rotates in the counterclockwise direction, the trigger pin 428 is positioned outside the cam slot 444 of the cylindrical cam cylinder 420. Move along the edge.

  [00198] When the guide pin 640 reaches the position CT3 in the cutting tip 632 and the trigger pin 428 reaches the position BC3 in the cylindrical cam cylinder 420, the trigger assembly 106, in particular the trigger 408, has its predetermined length in the longitudinal direction. Only about half of the allowable distance is advanced. As the user continues to pull trigger assembly 106, trigger 408 and trigger pin 428 continue to move proximally. When this occurs, the rotating direction of the cylindrical cam cylinder 420 and the cutting tip 632 switches from clockwise to counterclockwise. Further, when the cutting tip 632 moves to CT4 after passing the position CT3 adjacent to the guide pin 640, the rotation direction is switched from clockwise to counterclockwise, so that the outer sheath assembly 602 (the outer band 636 is moved). From the retracted position inside the outer sheath assembly 602 (including the outer band 636) to an extended or partially extended position. When the trigger pin 428 is in position BC4, (i) the cylindrical cam cylinder 420 and the cutting tip 632 rotate counterclockwise a distance (or half) that is slightly less than half of its predetermined allowable distance. (Ii) the guide pin 640 is at the position CT4, and (iii) the cutting tip 632 is at the most extended position.

  [00199] When the user pulls trigger 408 further, trigger pin 428 continues to move proximally from position BC4 to position BC5 in cylindrical cam cylinder 420, thereby causing cylindrical cam cylinder 420 and cutting tip 632 to counterclockwise. Continue to rotate around. Specifically, the cutting tip 632 rotates from position CC4 to CC6 adjacent to the guide pin 640, and moves from the extended position to the retracted position by the cam slot profile of the cutting tip 632. When the trigger pin 428 is located at position BC5 in the cam slot of the cylindrical cam cylinder 420, the trigger 408 has reached the end of its longitudinal movement in the proximal direction. When trigger pin 428 exceeds position BC5 in the cam slot of cylindrical cam cylinder 420, the constant load spring reverses the direction of trigger 408 and trigger pin 428 and advances it toward the distal position.

  [00200] As discussed above, when the cam slot of the cutting tip 432 is discontinuous, the clockwise or counterclockwise rotation of the cutting tip 432 is less than 360 degrees. Assuming that the predetermined amount of allowable rotation is about 275 degrees, the amount of clockwise angular rotation from BC1 to BC3 by the cylindrical cam cylinder 420 and from CT1 to CT3 by the cutting tip 632 The amount of angular rotation in the clockwise direction is about 275 degrees. The amount of angular rotation in the counterclockwise direction from BC3 to BC5 by the cylindrical cam cylinder 420 and the amount of angular rotation in the counterclockwise direction from CT3 to CT5 by the cutting tip 632 are about 275 degrees. Only 9 degrees larger. Additional rotation (or over-rotation) in this counterclockwise direction by the cylindrical cam cylinder 420 and the cutting tip 632 causes the cutting tip 632, including its cutting surface, to include the outer sheath assembly 602, particularly the outer band. Guaranteed to be protected by 636. When the trigger 408 reaches the last position BC5 of its longitudinal movement in the proximal direction, the cylindrical cam cylinder 420 and the cutting tip 632 move counterclockwise to positions BC6 and CT6, respectively. Keep doing. Specifically, the cylindrical cam cylinder 420 rotates about 17 degrees counterclockwise from position BC5 to BC6, thereby causing the cutting tip 632 to retract most from the position CT5 (not shown) at the cutting tip. It is rotated counterclockwise by the same amount to the position CT6 which is the position.

  [00201] When the trigger pin 408 is at the position BC6 in the cylindrical cam cylinder 420 and the guide pin 640 is at the position CT6 inside the cutting tip 632, the cylindrical cam cylinder 420 and the cutting tip 632 are still in their positions. It is necessary to return to the home positions BC1 and CT1. To return the cylindrical cam cylinder 420 and the cutting tip 632 to their home positions BC1 and CT1, the cylindrical cam cylinder 420 is moved from position BC6 to BC1, and the cutting tip 632 is moved from CT6 to CT1 in the clockwise direction. Rotate about 34.5 degrees. When the trigger pin 428 returns to its home position (BC1), (i) the cylindrical cam cylinder 420 and the cutting tip 632 are rotated 307.6 degrees counterclockwise (also 34.5 degrees clockwise). (Ii) the guide pin 640 is in the position CT1, and (iii) the cutting tip 632 is in the retracted position. That is, the cutting tip 632 (and the cylindrical cam cylinder 420) rotates in both the counterclockwise direction and the clockwise direction at the position of the reverse-extend-retreat (fixed position) sequence, but the reverse ( Rotation is net 273.1 degrees in the clockwise direction at the position of the fixed position) -extension-retract sequence, and 273.1 counterclockwise at the position of the reverse-extension-retract (fixed position) sequence. It is rotating. The user then repeats this process as necessary.

  [00202] A sheath assembly included in a surgical device provided by embodiments according to the present disclosure can be safely placed within a patient's vasculature to remove an implant such as a lead from the patient's vasculature. To separate. FIG. 12 depicts a surgical device 1206 with a sheath assembly 1212 inserted into the example patient 1204. The sheath assembly 1212 surrounds an implanted lead (not shown), passes along the left brachiocephalic vein, passes through the SVC, and is connected into or around the right ventricle of the heart. When the user of the surgical device 1206 surrounds the lead with the sheath assembly 1212, the handle assembly 1208 is actuated to expand, separate, and / or cut tissue surrounding the lead in the patient's SVC. First, a cutting blade (not shown) is extended beyond the distal end of the sheath assembly 1212 while rotating.

  [00203] When the handle assembly is actuated, the cutting blade extends and retracts into the sheath according to the cam slot profile of the cutting tip disclosed below. The cutting blade rotates in a first direction, i.e., a clockwise direction, according to the cam slot profile of the cylindrical cam cylinder, discussed below, during the initial or first operation of the handle assembly. When the clinician releases the handle assembly, the cutting blade is guaranteed to stay inside or return to the sheath assembly 1212 so that the clinician can move the sheath assembly away from further uncut tissue. It is possible to proceed by pressing the place. During subsequent or second actuation of the handle assembly, the cutting blade rotates in a second or counterclockwise direction according to the cam slot profile of the cylindrical cam cylinder discussed below. Each time actuation occurs, the proximal portion of the implanted lead and / or surrounding tissue further enters a hollow passage within the sheath assembly 1212. This process is repeated again until the implanted lead and / or surrounding tissue has been fully or significantly expanded, separated, and / or cut from tissue attached to the SVC. The implanted lead is then safely removed from the patient's SVC.

  [00204] Referring to FIG. 13, an exemplary surgical device 1206 is depicted. Surgical device 1206 includes a handle assembly 1208 and a flexible sheath assembly 1212. The flexible sheath assembly 1212 is discussed in more detail below and generally includes a flexible inner sheath assembly (not shown) disposed within the flexible outer sheath assembly. Desirably, the inner sheath can move (eg, rotate and extend) relative to the outer sheath while the outer sheath remains stationary. Both the inner and outer sheaths can be flexible, rigid, or a combination thereof.

  [00205] Referring to FIG. 15A, an exemplary handle assembly 1208 is depicted. Handle assembly 1208 includes some or all of the following components: handle frame 1504, trigger 1508, spring assembly 1512, strain relief component 1516, cylindrical cam assembly 1519, bushing 1524, and end cap 1527. The handle frame 1504 is constructed from a single part or multiple parts, such as two halves as shown in FIG. 15A.

  [00206] Referring to FIG. 15B, an example trigger 1508 is shown. The trigger 1508 depicted in FIG. 15B includes one opening 1530 through which a clinician's finger can be inserted. However, the trigger may have multiple openings. In addition, the trigger may consist of a straight or non-linear member without an opening. In addition, the trigger may be in the form of a button that can be depressed. As long as the trigger is ergonomically appropriate and comfortable for the clinician, alone or with the handle frame, the trigger may have various sizes and shapes.

  [00207] The trigger 1508 shown in FIG. 15B includes a trigger pin 1528 extending vertically from the top of the trigger 1508. FIG. The trigger pin 1528 is formed from a metal such as a copper alloy (eg, brass or bronze, in particular C 630 nickel aluminum bronze) and includes a termination that is shaped like a truncated cone to facilitate insertion into the handle frame 1504. The trigger pin 1528 cooperates with the groove of the cylindrical cam cylinder of the cylindrical cam assembly 1519 and functions as a follower of the cylindrical cam cylinder. The trigger 1508 also includes a pair of sliders 1532 that project horizontally from the proximal end of the trigger 1508 and a pair of sliders 1536 that project horizontally from the distal end of the trigger 1508. When the trigger 1508 is disposed within the handle assembly 1208, the sliders 1532, 1536 are in corresponding grooves within the handle frame 1504 and slide therein. The trigger 1508 also includes a post 1540 that extends vertically from the top of the trigger 1508 (preferably from the distal end of the top of the trigger 1508). Post 1540 connects to spring assembly 1512.

  [00208] As described above, the handle assembly 1208 includes a strain relief component 1516. The strain relief component 1516 is attached to the distal end of the handle frame 1504 as shown in FIG. 15A and tapers from the proximal end toward the distal end. The strain relief component 1516 also has a lumen therethrough, which allows the sheath assembly 1212 to extend through the lumen and into the handle assembly 1208. The strain relief component 1516 is constructed from a flexible material such as Santoprene ™ thermoplastic vulcanizate produced by ExxonMobil. The material of the strain relief component and the shape of the strain relief component provide a flexural modulus to protect the flexible shaft as it extends into the rigid handle. The lumen of the strain relief component also includes a counterbore that allows the auxiliary outer sheath to be merged during device preparation.

  [00209] Referring to FIG. 15C, an exemplary cylindrical cam assembly 1519 is shown. The cylindrical cam assembly 1519 includes a cylindrical cam cylinder 1520 that conveys the follower guide 1521 rotatably. As described in more detail below, a cylindrical cam cylinder 1520 and follower guide 1521 cooperate with trigger pin 1528 to provide a cylindrical cam.

  [00210] The cylindrical cam cylinder 1520 is formed from one or more biocompatible materials, such as polyethylene filled Delrin®, stainless steel, anodized aluminum, brass, titanium, and the like. As shown in FIG. 15D, the cylindrical cam cylinder 1520 has an outer surface with a cam groove (or slot or channel) 1544 that receives the trigger pin 1528 in a translatable manner. FIG. 15E represents a two-dimensional view of the profile of the cam slot 1544 of the cylindrical cam cylinder 1520. Cam slot 1544 defines a generally “hourglass” or “eighth-shaped” path for a follower (ie, trigger pin 1528). As described in more detail below, when an initial or first actuation is applied to trigger 1508, trigger pin 1528 traverses approximately half of cam slot 1544 and subsequent or second actuation triggers. When added to 1508, the trigger pin 1528 traverses the remainder of the cam slot 1544, ie about half of the cam slot 1544. In each case, the follower guide 1521 causes the trigger pin 1528 to go straight through the intersection (or intersection) 1545 of the cam slot 1544 during actuation of each trigger 1508, as will be described in more detail below. In other words, the follower guide 1521 causes the trigger pin 1528 to advance from the first leg 1547 of the cam slot 1544 to the second parallel leg 1549 of the cam slot 1544 and then from the third leg 1551 of the cam slot 1544. Proceed to the fourth parallel leg 1553 in slot 1544.

  [00211] FIGS. 15F and 15G show a longitudinal sectional view and a sectional view of a cylindrical cam cylinder 1520, respectively. A lumen 1556 extends through the proximal end 1548 and the distal end 1552 of the cylindrical cam cylinder 1520. The distal end 1552 of the lumen 1556 of the cylindrical cam cylinder 1520 is designed to coincide with the exterior of the proximal end of the inner key 1612, which will be discussed in more detail below. The cross section of the distal end 1552 of the lumen 1556 of the cylindrical cam cylinder 1520 is preferably non-circular. For example, one embodiment of a non-circular lumen includes two chamfered side surfaces 1564, one of the chamfered side surfaces 1564 is not offset and the other of the chamfered side surfaces 1564 is offset (eg, about 8 degrees). Has been. The distal end of the tubular cam cylinder 1520 coincides with the exterior of the proximal end of the inner key 1612 to transmit torque from the tubular cam cylinder 1520 via the inner key 1612 to the inner sheath assembly. As designed, the outer cross-section of the proximal end of the inner key 1612 will have a complementary profile of the lumen 1556. Although the cross-sectional shape of a non-circular lumen has been described as having two chamfered side surfaces 1564, the present disclosure is not limited to such a shape, but is square, rectangular, D-shaped, triangular, diamond-shaped , Trapezoids, pentagons, hexagons, octagons, parallelograms, ellipses, and other non-circular shapes. Alternatively, the inner key can be coupled to the outside of the cylindrical cam cylinder.

  [00212] The proximal end of the cylindrical cam cylinder 1520 coincides with the bushing 1524. Specifically, the outer distal end of bushing 1524 is disposed within the proximal end of lumen 1556. Both the outer distal end of the bushing 1524 and the proximal end of the lumen 1556 are shaped circularly so that the bushing 1524 and the cylindrical cam cylinder 1520 can rotate relative to each other. However, the outer proximal end of the bushing 1524 is disposed within a groove inside the handle frame 1504 so that the bushing 1524 and the cylindrical cam cylinder 1520 move longitudinally within the handle assembly 1208. To prevent.

  [00213] The follower guide 1521 is formed from one or more biocompatible materials such as stainless steel, anodized aluminum, titanium, and the like. In some embodiments, the coefficient of friction between the follower guide 1521 and the cylindrical cam cylinder 1520 is relatively large. The follower guide 1521 is rotatably conveyed by the cylindrical cam cylinder 1520. Therefore, the follower guide 1521 is preferably made of a different material from the cylindrical cam cylinder 1520 so as not to be worn out. In some embodiments, the inner surface of the follower guide 1521 has a slightly different cross-section than that of the outer surface of the cylindrical cam cylinder 1520 to prevent accidental rotation of the follower guide 1521 relative to the cylindrical cam cylinder 1520. Has a shape. For example, the outer surface of cylindrical cam cylinder 1520 has a circular cross-sectional shape, and the inner surface of follower guide 1520 has a slightly non-circular cross-sectional shape.

  [00214] As shown in FIG. 15H, the follower guide 1521 is a generally cylindrical component that includes an opening 1565. The trigger pin 1528 extends through the opening 1565 and enters the cam slot 1544 of the cylindrical cam cylinder 1520. As described in more detail below, the first wall 1567 and the second wall of the opening 1565 extend diagonally (ie, extend diagonally relative to the longitudinal axis of the tubular cam assembly 1519). A wall 1569 engages the trigger pin 1528 to advance the trigger pin 1528 straight through the intersection 1545 of the cam slot 1544. In addition, as described in more detail below, the follower guide 1521 includes a first wall 1567 and a second wall extending diagonally between the first and second actuations of the trigger 1508. In order to properly position the wall 1569, it rotates relative to the cylindrical cam cylinder 1520. Opening 1565 includes first and second longitudinally extending walls 1571 and 1573 (ie, cylindrical cams) that engage trigger pin 1528 to facilitate rotation of follower guide 1521 relative to cylindrical cam cylinder 1520. Wall extending parallel to the longitudinal axis of assembly 1519).

  [00215] A first wall 1567 and a second wall 1569 extending diagonally, a first wall 1571 and a second wall 1573 extending longitudinally, and other walls defining an opening 1565 are: The follower guide 1521 extends from the inner surface to the outer surface. In some embodiments, these walls extend radially between the inner and outer surfaces. In some embodiments, the walls extend diagonally between the inner surface and the outer surface (ie, the walls form a bite between the inner surface and the outer surface).

  [00216] Referring now to FIGS. 15J and 15K, the relative rotation blocking mechanism 1575 that the cylindrical cam assembly 1519 further includes, as the name implies, provides some rotation of the follower guide 1521 relative to the cylindrical cam cylinder 1520. Is to prevent. In general, the relative rotation prevention mechanism 1575 allows the follower guide 1521 to occupy the first relative rotation prevention position and the second relative rotation prevention position. In the first relative rotation prevention position, the mechanism 1575 allows the follower guide 1521 to rotate in the first direction (ie, toward the second relative rotation prevention position) with respect to the cylindrical cam cylinder 1520; The follower guide 1521 is prevented from rotating in the second direction with respect to the cylindrical cam cylinder 1520. In the second relative rotation prevention position, the mechanism 1575 allows the follower guide 1521 to rotate in the second direction (ie, toward the first relative rotation prevention position) with respect to the cylindrical cam cylinder 1520; The follower guide 1521 is prevented from rotating in the first direction with respect to the cylindrical cam cylinder 1520.

  [00217] In some embodiments, as shown in FIGS. 15J and 15K, the relative rotation blocking mechanism 1575 is a longitudinally extending tab (or arm) 1577 (FIG. 15C) conveyed by a follower guide 1521. And FIG. 15H) and a semi-annular flange 1579 (see also FIGS. 15C and 15D) conveyed by the cylindrical cam cylinder 1520. FIG. 15J shows one such embodiment of the relative rotation blocking mechanism 1575 in the first relative rotation blocking position (the arm 1577 engages the first side of the semi-annular flange 1579), and FIG. One such embodiment of the relative rotation blocking mechanism 1575 is shown in the second relative rotation blocking position (the arm 1577 engages the second side of the semi-annular flange 1579).

  [00218] In some embodiments, the relative rotation blocking mechanism 1575 employs other forms. For example, the mechanism 1575 includes one or more magnets that maintain the follower guide 1521 in a first relative rotation blocking position and a second relative rotation blocking position.

  [00219] Referring to FIG. 15L, an exemplary spring assembly 1512 is depicted. The spring assembly 1512 includes a constant load spring 1572 and a spool 1574. One end of the constant load spring 1572 is connected to the spool 1574, and the other end of the constant load spring 1572 is connected to a post 1540 extending from the trigger 1508. As the clinician pulls the trigger 1508 proximally, the sliders 1532, 1536 slide through the grooves in the handle frame 1504, thereby causing the trigger 1508 to move vertically within the handle assembly 1208. Preventing and only allowing movement from the distal end to the proximal end and / or vice versa along the longitudinal axis of the surgical device 1206. As the trigger 1508 moves proximally, the constant load spring 1572 extends, thereby creating tension and distal force. Therefore, when the clinician releases the trigger 1508, the constant load spring 1572 contracts, pulling the trigger 1508 back to its original, most distal position.

  [00220] Referring to FIG. 16, a front view of one embodiment of an assembled sheath assembly 1212 of the present disclosure is depicted. The sheath assembly 1212 includes an inner sheath assembly and an outer sheath assembly. Referring to FIG. 16A, an exploded view of the distal end of the sheath assembly 1212 is shown, FIG. 16B is an exploded view of the proximal end and center of the sheath assembly 1212, and the sheath assembly 1212 is Some of the parts such as outer band 1636, guide pin 1640, cutting tip 1632, flexible inner sheath 1620, flexible outer sheath 1624, outer jacket 1628, inner key 1612, outer key 1608, and rigid inner tube 1616. Or all of them.

  [00221] Referring to FIG. 17A, one embodiment of an outer sheath assembly 1602 of the present disclosure is illustrated. Outer sheath assembly 1602 includes an outer band 1636 disposed and attached to the distal end of elongate flexible outer sheath 1624 and an outer key 1608 disposed and attached to the proximal end of flexible outer sheath 1624. Including. The outer band 1636 is attached to the distal end of the flexible outer sheath 1624 by an interlock or other known attachment means such as welding, adhesives, press-fit techniques, bamboo shoot fittings. All such attachment techniques within the knowledge of those skilled in the art are considered to be within the scope of this disclosure. Similarly, the outer key 1608 is attached to the proximal end of the flexible outer sheath 1624 by an interlock or other known attachment means such as welding, adhesives, press-fit techniques, bamboo shoot joints. Although not shown in FIG. 17A, the outer sheath assembly 1602 also includes a flexible outer jacket 1628 (see FIG. 16A) that covers the outer sheath 1624 and contacts the outer band 1636, thereby allowing relatively The outer sheath assembly 1602 has a smooth, continuous, uninterrupted outer profile. The flexible jacket also includes a blood outlet from the system.

  [00222] Referring to FIG. 17B, one embodiment of an inner sheath assembly 1604 of the present disclosure is illustrated. Inner sheath assembly 1604 includes a cutting tip 1632, a flexible inner sheath 1620, an inner key 1612, and a rigid inner tube 1616. The proximal end of the cutting tip 1632 is attached to the distal end of the flexible inner sheath 1620, and the distal end of the inner tube 1616 is attached to the proximal end of the flexible inner sheath 1620, Key 1612 is attached to the proximal end of inner tube 1616. Means for attaching these parts include welding, adhesives, press fit techniques or other known means of attachment. As discussed below, guide pin 1640 couples outer band 1636 with cutting tip 1632, and guide pin 1640 is included in either inner sheath assembly 1604 or outer sheath assembly 1602.

  [00223] Preferably, a portion of either the inner sheath 1620 and / or the outer sheath 1624 is rigid and a portion of the outer sheath is flexible. Both the rigid and flexible portions are constructed from materials suitable for insertion into the human body. For example, the rigid portion is constructed from stainless steel and the flexible portion is constructed from a plastic polymer such as polytetrafluoroethylene or a thermoplastic elastomer. Assuming that both rigid and flexible portions are used, these will form a unitary inner and / or outer sheath. As represented in FIG. 17B, the rigid inner tube 1616 is not only attached to the inner key 1612 but also inserted through the inner key 1612 and from both the proximal and distal ends of the inner key 1612. Elongate. The rigid tube 1616 is attached to and extends from the inner key 1612 to increase the amount of torque that can be transferred from the cylindrical cam to the rigid tube 1616 via the inner key 1612, eventually The amount of torque that can be transmitted to the cutting tip 1632 via the sheath assembly 1604 can be increased. The rigid tube extends through the handle, providing an access point for introducing other medical devices. This stretching also provides a means of controlling the blood outlet after the lead has been withdrawn.

  [00224] It is desirable that at least a portion of the outer sheath 1624 and the inner sheath 1620 be generally flexible to receive, contain, and advance the patient's vasculature. In addition to being flexible, the inner sheath 1620 receives torque transmitted from the cylindrical cam cylinder / inner key and transmits sufficient torque to the cutting tip 1632, discussed in more detail below. In addition, it has high rigidity. Inner sheath 1620 (and / or outer sheath 1624) is formed from polymer extrusion, mesh reinforced polymer extrusion, coil, double coil, triple coil, laser cut metal tube and any combination thereof. The inner sheath (and / or outer sheath 1624) is an integral structure consisting of multiple parts.

  [00225] Referring to FIG. 18, a cross-sectional view of one embodiment of a sheath assembly 1212 comprising an inner sheath assembly 1604 disposed within an outer sheath assembly 1602 is depicted. Referring to FIG. 18C, an enlarged view of the inner key 1612 of the inner sheath assembly 1604 positioned within the outer key 1608 of the outer sheath assembly 1602 is shown. As discussed above, the exterior of the inner key 1612 is designed to coincide with the lumen 1556 at the distal end of the cylindrical cam cylinder 1520. Therefore, the outer cross section of the proximal end of the inner key 1612 will have a complementary profile with respect to the distal end of the lumen 1556 inside the cylindrical cam cylinder 1520. For example, the cross section of the distal end 1552 of the lumen 1556 of the cylindrical cam cylinder 1520 is non-circular and has two chamfered sides, one of the chamfered sides is not offset and the other is chamfered. Assuming that the lateral sides are offset (eg, about 8 degrees), the exterior of the proximal end of the inner key 1612 also has a non-circular profile with two chamfered sides, with one chamfered side Will not be offset and the other chamfered side will be offset (eg, about 8 degrees). Inner key 1612 and outer key 1608 provide a means for rotational coupling. The inner key 1612 is a means for rotationally coupling the inner sheath assembly 1604 to the cylindrical cam, and the outer key is a means for rotationally coupling the outer shaft assembly to the handle. is there. Inner key 1612 and outer key 1608 provide journal bearings for other keys.

  [00226] As further shown in FIG. 18C, the inner key 1612 has a circular cross section in which the outer distal end of the inner key 1612 matches the circular cross section of the proximal end of the inner lumen of the outer key 1608. At least partially so that it can rotate freely within the outer key 1608. In addition, because the inner key 1612 and the outer key 1608 are softly coupled, the inner key 1612 and the outer key 1608 can move longitudinally relative to each other. For example, assuming that the outer key 1608 is fixed so that it does not rotate or move longitudinally, the inner key 1612 can rotate within the outer key 1608 and advance longitudinally. You can also. Therefore, when the cylindrical cam cylinder 1520 rotates, the inner key 1612 will rotate within the outer key 1608 and the inner sheath assembly 1604 will include rotation of the cutting tip 1632 within the outer band 1636. Thus, the outer sheath assembly 1602 is rotated. Also, the cam slot profile of the cutting tip 1632 includes the longitudinal movement of the inner key 1612 relative to the outer key 1608 and the longitudinal movement of the cutting tip 1632 relative to the outer band 1636 of the outer sheath assembly 1602. Controls the longitudinal movement of the inner inner sheath assembly 1604.

  [00227] With continued reference to FIG. 18C, the lumen inside the outer key 1608 has a step-down or abutment as it proceeds from the proximal end to the distal end, so that the lumen is directed toward the proximal end. Increases and decreases toward the distal end. Because there is a transition from a large lumen to a small lumen within the outer key 1608, the distal end of the larger lumen of the outer key 1608 is between the distal end of the inner key 1612 and the abutment. An adjustable gap 1610 is shown. This gap increases, decreases and / or remains the same according to the cam slot profile of the cutting tip 1632. The abutment of the outer key 1608 ensures that the inner key 1612 travels only a limited longitudinal distance inside the outer key 1608, thereby moving the cutting tip 1632 distal to the outer band 1636. Limiting the possible longitudinal movement of the inner sheath assembly 1604 within the outer sheath assembly 1602, including limiting the longitudinal movement of the inner sheath assembly 1604.

  [00228] Referring to FIG. 18A, an enlarged cross-sectional view of the distal end of a sheath assembly 1212 having an inner sheath assembly 1604 coupled with an outer sheath assembly 1602 via a guide pin 1640 is depicted. The blade 1822 of the distal end portion 1632 is disposed in the outer sheath assembly 1602 in the retracted position. As discussed above, the outer band 1636 included at the distal end of the outer sheath assembly 1602 is constructed from a biocompatible metal, such as stainless steel, and is polished smoothly throughout, with its distal most Uniformly rounded at the point so that it can act as a dilator when pressed against the tissue. The distal end 1822 of the cutting tip 1632 includes a cutting surface that can cut tissue. The inner sheath assembly 1604 is coupled to the outer sheath assembly 1602 via guide pins 1640 by a cutting tip 1632 and an outer band 1636, respectively. One end of the guide pin 1640 is fixed inside the outer band 1636, and the other end of the guide pin 1640 is arranged inside the cam slot 1814 of the cutting tip 1632. As the inner sheath 1620 rotates, the cutting tip 1632 also rotates upon actuation of the trigger assembly discussed above because the inner sheath 1620 is fixedly attached to the cutting tip 1632. As the cutting tip 1632 rotates, the cutting tip 1632 also extends distally in the direction of the arrow (→) as represented in FIG. 18A ′ according to the profile of the cam slot 1814. As the cutting tip 1632 extends distally and rotates, the guide pin 1640 and the outer sheath assembly 1602, particularly the outer band 1636, remain stationary. Thus, when the cutting tip 1632 extends distally (possibly retracts proximally according to the cam slot profile) and rotates, the cutting surface at the distal end 1822 of the cutting tip 1632 is against the tissue. The tissue can be cut by performing a cutting action.

  [00229] FIG. 18A further illustrates the cutting tip 1632 in a retracted (possibly non-actuated) position because the cutting tip 1632 is in a proximal position. In other words, the distal end 1822 of the cutting tip 1632 of FIG. 18A is disposed within the outer sheath assembly 1602, particularly the outer band 1636, and extends beyond the distal end of the outer band 1636. There is no. Referring to FIG. 18A ', the cutting tip 1632 is shown in an extended (and actuated) position as it extends beyond the distal end of the outer sheath assembly 1602 and the outer band 1636.

  [00230] FIG. 14 depicts the distal portion of the flexible outer sheath and flexible inner sheath surrounding the lead 330 inside the patient's vein 334, with the cutting tip 1632 in the extended position. Due to the peripheral nature of the cutting surface at the distal end of the cutting tip 1632 (eg, a knurled blade), the surgical device acts as a coring device, thereby causing tissue 338 around the lead or implant being extracted. Are cut partially (ie, less than 360 degrees) or completely (ie, 360 degrees). The amount of tissue that the cutting surface cuts depends on the size, shape and configuration of the leads and the diameter and thickness of the circular cutting blade. For example, if the diameter of the circular cutting surface is substantially larger than the diameter of the lead, this cutting surface will cut and decenter more tissue compared to a cutting surface with a smaller diameter. become.

  [00231] The inner and outer sheaths are coupled to each other via a cutting tip, an outer band and a guide pin, but the inner and outer sheath assemblies may be coupled to each other in other ways. In other words, after understanding the present disclosure for joining the sheath in a manner that allows the cutting surface to extend and rotate beyond the distal end of the outer sheath, those skilled in the art will be disclosed. It should be understood how to make and use the various aspects, embodiments, and / or configurations. All such configurations within the purview of those skilled in the art are considered to be within the scope of this disclosure.

  [00232] Referring to FIGS. 19A, 19B, and 19C, an exemplary outer band 1636 is illustrated. The outer band 1636 is a generally cylindrical sleeve of a hollow cylinder. The exterior of the outer band 1636 is non-uniform, but the hollow cylinder can be uniform. The inside of the outer band 1636 is uneven. For example, within the outer band 1636, the cutting tip (not shown in FIGS. 19A, 19B, and 19C) moves further from the proximal end 1912 to the distal end 1908 inside the outer band 1636. An abutment 1916 is included. Outer band 1636 includes a hole 1904 for receiving and possible attachment of a radially inwardly projecting guide pin (not shown in FIGS. 19A, 19B and 19C). As discussed in more detail above, the guide pin engages the cam slot of the cutting tip. The size, shape and configuration of the outer band 1636 can vary depending on how it is attached to the flexible outer sheath. As discussed above, the outer sheath is stationary. If so, the outer band 1636 and the guide pin remain stationary as the cutting tip moves (eg, rotates and moves longitudinally) relative to them. The outer band includes a journal bearing surface for aligning the cutting blade during operation and providing a surface that separates tissue as the cutting blade retracts into the interior of the device.

  [00233] Referring to FIGS. 20A, 20B, 20C, and 20D, an exemplary cutting tip 1632 is illustrated. The cutting tip 1632 has a hollow cylindrical shape as a whole. Cutting tip 1632 includes a proximal portion 2024, an intermediate portion 2028, and a distal portion 2032. The outer diameter of the proximal portion 2024 is sized to allow insertion and / or engagement (otherwise attachment) of the proximal portion 1024 to the inner diameter of the inner flexible sheath (not shown). is there. The distal end of the cutting tip 1632 includes a cutting surface 2012 having a serrated sharp blade profile. A cut channel (or cam slot) 2016 is provided inside the outer surface of the intermediate portion 2028. As the inner flexible sheath rotates within the outer sheath, from the proximal end to the distal end, the outer sheath and pin remain stationary. If so, an inner sheath (not shown) connected to the cutting tip 1632 forces the cutting tip 1632 to rotate. The cam slot 2016 engages the guide pin, and the shape and profile of the cam slot 2016 controls the speed and distance that the cutting tip 1632 moves in the longitudinal direction. That is, the configuration of the cam slot 2016 controls the direction and amount of longitudinal movement, such as distal movement of the cutting tip toward the extended position and / or proximal movement toward the retracted position, The cutting tip rotates either in a clockwise direction or in a counterclockwise direction.

  [00234] Referring again to FIGS. 20A, 20B, 20C, and 20D, the cutting tip 1632 also includes a step-up 2020 such that the diameter of the intermediate portion 2028 is greater than the diameter of the distal portion 2032. As the cutting tip 1632 rotates and the cutting surface 2012 extends beyond the distal end of the outer band to the extended position, the step-up 2020 of the cutting tip 1632 contacts the abutment of the outer band, thereby Even if the pin is sheared, it limits the distance traveled by the cutting tip 1632 and / or the cutting tip 1632 exits or extends beyond the distal end of the outer sheath assembly, particularly the outer band. To prevent.

  [00235] The profile of the cam slot at the cutting tip is disclosed in US patent application Ser. No. 13 / 834,405 entitled “Retractable Blade For Lead Removable Device” filed on Mar. 15, 2013. The entire patent application is hereby incorporated herein by reference for all of its teachings and purposes. For example, the cam slot has a substantially linear profile, a substantially sinusoidal profile, or an individual combination and / or a combination of linear and non-linear profiles. In addition, the cam slot may have an open continuous configuration to allow the cutting tip to rotate continuously or when the cutting tip reaches a fully extended position. The cam slot has a closed and discontinuous configuration so that the trigger tip must be released or flipped so that the cutting tip is actuated again after returning to its original retracted position. Also good. For example, the cam slot 2016 in FIG. 20A is discontinuous because it does not go around the entire circumference of the cutting tip 1632. In some embodiments, as shown in FIGS. 21 and 22A-22C, the cam slot 2016 is symmetric with respect to a longitudinally extending plane. Although certain figures of this disclosure show only one of an open cam slot configuration or a closed cam slot configuration, either configuration is the inner cam disclosed and / or discussed herein. Can be used with any of these embodiments and are considered within the scope of this disclosure. In addition, a partial lobe cam (including a cam slot that surrounds the outer surface of the cutting tip by less than 360 degrees), a single lobe cam (a cam slot that surrounds the outer surface of the cutting tip by 360 degrees). Various types of cams are possible, including double-lobe cams (including cam slots that surround the outer surface of the cutting tip 720 degrees) and / or other multi-lobe cams.

  [00236] The distal end of the cutting tip 1632 is disclosed in US patent application Ser. No. 13 / 834,405 entitled “Retractable Blade For Lead Removable Device” filed on Mar. 15, 2013. Cutting surface 2012 having various blade profiles, the entirety of which is hereby incorporated herein by reference for all of its teachings and purposes. For example, the plane of the cutting surface 2012 at the distal end of the cutting tip shown in the figures of this disclosure is parallel to the plane of the proximal end of the cutting tip. However, the plane of the cutting surface may be offset (0 degrees to 90 degrees) from the plane of the proximal end of the cutting tip. Also, as discussed above, the profile of the cutting surface 2012 of FIGS. 10A-10D has a plurality of serrations. The profile of the cutting surface 2012 need not be serrated, but may comprise other configurations such as a constant profile and / or a profile combining smooth and sharp portions. The profile of the cutting surface 2012 of FIGS. 20A-20D has six serrations. However, it may be desirable to have fewer than six serrations or more than six serrations. It is also desirable to have a number of serrations between 5 and 7, a number of serrations between 4 and 8, or a number of serrations between 6 and 10.

  [00237] Although the cutting surface 2012 shows a certain number of serrations, FIGS. 20A-20D are not intended to represent the only number and type of serrations included in the saw-shaped cutting surface. Those skilled in the art, after understanding the present disclosure for adjusting the number, size, and configuration of serrations, rely on the size of the surgical device, including the sheath and cutting tip, to disclose the disclosed aspects, embodiments, and One will understand how to make and / or use a configuration. All such configurations within the purview of those skilled in the art are considered to be within the scope of this disclosure. In addition, serrations include, but are not limited to, squares, rectangles, rhombuses, parallelograms, trapezoids, triangles, circles, ellipses, folds, etc. and any number of different shapes and configurations.

  FIG. 21 shows a two-dimensional view of the profile of the cam slot 2016 for the cutting tip 1632, the profile of the cam slot 1544 of the cylindrical cam cylinder 1520, and the profile of the opening 1565 of the follower guide 1521. 22A-22C show that actuation of the trigger 1508 and resulting movement of the trigger pin 1528 is dependent on rotational movement of the cylindrical cam cylinder 1520, follower guide 1521 and cutting tip 1632 and translational motion of the cutting tip 1632. It expresses how to bring In these drawings, the horizontal axis of the profile of the slots 2016 and 1544 is the rotation (degree) of the cutting tip 1632 and the cylindrical cam cylinder 1520. For example, as shown in FIG. 20A, when the profile of the cam slot of the cutting tip 1632 is discontinuous, the rotation of the cutting tip 1632 is less than 360 degrees. The rotation of the cutting tip 1632 is between 5 and 355 degrees, between 180 and 355 degrees, between 210 and 325 degrees, between 240 and 295 degrees, or between 270 and 275 degrees. Between is desirable. The rotation of the cutting tip 1632 is approximately 180 degrees, 185 degrees, 190 degrees, 200 degrees, 205 degrees, 210 degrees, 215 degrees, 220 degrees, 225 degrees, 230 degrees, 235 degrees, 240 degrees, 245 degrees, 250 Degrees, 255 degrees, 260 degrees, 265 degrees, 270 degrees, 275 degrees, 280 degrees, 285 degrees, 290 degrees, 300 degrees, 305 degrees, 310 degrees, 315 degrees, 320 degrees, 325 degrees, 330 degrees, 335 degrees, 340 degrees, 345 degrees, 350 degrees or 355 degrees are also desirable. The vertical axis of the profile of the cam slot 2016 for the cutting tip 1632 is the amount of displacement (if any) in the longitudinal direction of the cutting tip 1632. The vertical axis of the profile of the cam slot 1544 of the cylindrical cam cylinder 1520 is the amount of displacement in the longitudinal direction of the trigger assembly (and trigger pin 1528).

  [00239] In FIGS. 22A-22C, the opening 1565 of the follower guide 1521 is shown as a dashed line and is placed on the profile of the cam slot 1544 of the cylindrical cam cylinder 1520 to indicate the rotational position of the opening 1565 relative to the cam slot 1544. ing. As shown in FIGS. 22A-22C and described in more detail below, the rotational position of the opening 1565 relative to the cam slot 1544 changes during operation of the trigger 1508.

  [00240] Generally, by an initial actuation of trigger 1508, a first actuation (ie, pulling trigger 1508 to the extent allowed by the handle assembly and then releasing trigger 1508 back to its home position). As a result, a rotational displacement of about 254 degrees occurs in one direction (clockwise when the tip is viewed from the handle) in the cutting tip 1632 and the cylindrical cam cylinder 1520. Also, with the first actuation, cutting tip 1632 extends from outer band 1636 as it rotates and then returns to the retracted position. Subsequent actuation of trigger 1508, the second actuation, results in cutting tip 1632 and cylindrical cam cylinder 1520 having approximately 254 in the opposite direction (counterclockwise when viewing the tip from the handle). Degree of rotational displacement occurs. Also, due to the second action, the cutting tip 1632 extends from the outer band 1636 as it rotates, and then returns to the retracted position. The additional “odd-numbered” actuation (ie, third actuation, fifth actuation, etc.) results in the same device motion as during the first actuation of trigger 1508, resulting in an additional “even-numbered” actuation (ie, (4th actuation, 6th actuation, etc.) results in the same device motion as during the second actuation of trigger 1508.

  [00241] The following discussion includes rotation of the cylindrical cam cylinder 1520, rotation of the follower guide 1521, rotation of the cutting tip 1632, movement of the handle in the longitudinal direction (via the position of the trigger pin 1528), The interaction between the cutting tip 1632 and the longitudinal movement of the cutting tip 1632 will be described more specifically.

[00242] First, with particular reference to FIGS. 22A, 23A, 23B, and 23C, the following is a description of the positions BC1′-BC3 ′ of the trigger pin 1528 inside the cam slot 1544 of the cylindrical cam cylinder 1520. At these positions, the follower guide 1521 is in the first relative rotation prevention position and rotates together with the cylindrical cam cylinder 1520.
BC1′—Trigger pin 1528 is in a first home position within the cam slot of cylindrical cam cylinder 1520. The trigger 1508 of the trigger assembly is also in its home position.
BC2'-trigger pin 1528 has been moved longitudinally in the proximal direction, thereby rotating cylindrical cam cylinder 1520 in a clockwise direction. The trigger pin 1528 engages a wall 1567 extending on the first diagonal of the opening 1565 of the follower guide 1521.
BC3′-trigger pin 1528 has undergone further longitudinal movement in the proximal direction, thereby further rotating cylindrical cam cylinder 1520 in the clockwise direction. The trigger pin 1528 engages with a wall 1571 extending in the first longitudinal direction of the opening 1565 of the follower guide 1521.

[00243] Positions BC1 'to BC3' of the trigger pin 1528 inside the cam slot 1544 of the cylindrical cam cylinder 1520 correspond to positions CT1 'to CT3' of the guide pin 1640 inside the cam slot of the cutting tip 1632. The following is a description of the positions CT1′-CT3 ′ of the guide pins 1640 inside the cam slot of the cutting tip 1632.
CT1'-guide pin 1640 is in a first home position within the cam slot 2016 of the cutting tip 1632 and the cutting tip 1632 is in a retracted position inside the outer sheath assembly 1602 (including the outer band 1636). .
CT2′—Cutting tip 1632 completes about half of its predetermined rotation in the clockwise direction relative to guide pin 1640 inside cam slot 2016. Cutting tip 1632 is in the most extended position, outside outer sheath assembly 1602.
CT 3 ′ —Cutting tip 1632 has undergone further rotation in a clockwise direction relative to guide pin 1640 inside cam slot 2016. The cutting tip 1632 is in an intermediate position between the extended position and the retracted position inside the outer sheath assembly 1602 or the retracted position inside the outer sheath assembly 1602.

  [00244] By starting the first operation of the trigger 1508 as described above, the trigger pin 1528 moves from its first home position BC1 'to the intersection 1545 (position BC2') of the cam slot 1544 of the cylindrical cam cylinder 1520. Move to. By this action, the cylindrical cam cylinder 1520 and the cutting tip 1632 rotate by about 127 degrees in the clockwise direction. The trigger pin 1528 engages a wall 1567 extending in the first diagonal of the opening 1565 of the follower guide 1521 at the position BC2 ′ so that the trigger pin 1528 passes straight through the intersection 1545 of the cam slot 1544 of the cylindrical cam cylinder 1520. Guarantee to go forward. In other words, the trigger pin 1528 advances from the first leg 1547 of the cam slot 1544 to the second leg 1549 of the cam slot 1544. In other words, the follower guide 1521 ensures that the trigger pin 1528 traverses the first slot portion defined by the first leg 1547 and the second leg 1549. This ensures that the cylindrical cam cylinder 1520 continues to rotate in the clockwise direction. Engagement of the trigger pin 1528 with the wall of the opening 1565 of the follower guide 1521 tends to rotate the follower guide 1521 in the clockwise direction with respect to the cylindrical cam cylinder 1520. However, such movement is blocked by the relative rotation blocking mechanism 1575 in the first relative rotation blocking position.

  [00245] By continuing the first actuation of trigger 1508, trigger pin 1528 moves from position BC2 'to position BC3'. By this action, the cylindrical cam cylinder 1520 and the cutting tip 1632 rotate by about 50 degrees in the clockwise direction. The trigger pin 1528 engages with a wall 1571 extending in the first longitudinal direction of the opening 1565 of the follower guide 1521 at the position BC3 '. As described in more detail below, when trigger pin 1528 moves past position BC3 ', follower guide 1521 rotates counterclockwise with respect to cylindrical cam cylinder 1520.

[00246] Referring now to FIGS. 22B and 23D, the following is a description of the positions BC4′-BC6 ′ of the trigger pin 1528 within the cam slot 1544 of the cylindrical cam cylinder 1520. At these positions, the follower guide 1521 is in the second relative rotation prevention position and rotates together with the cylindrical cam cylinder 1520.
BC4'-trigger pin 1528 has completed almost all of its longitudinal movement in the proximal direction, and cylindrical cam cylinder 1520 has completed its clockwise rotation. The follower guide 1521 has been rotated to the second relative rotation prevention position by the trigger pin 1528.
BC5′—Trigger pin 1528 has been moved longitudinally in the distal direction. The cylindrical cam cylinder 1520 remains stationary.
BC6'-trigger pin 1528 has undergone further longitudinal movement in the distal direction. The trigger pin 1528 is in a second fixed position inside the cam slot of the cylindrical cam cylinder 1520. The trigger 1508 of the trigger assembly is also in its home position.

[00247] Positions BC4 'to BC6' of the trigger pin 1528 inside the cam slot of the cylindrical cam cylinder 1520 correspond to positions CT4 'to CT6' of the guide pin 1640 inside the cam slot of the cutting tip 1632. The following is a description of the positions CT4′-CT6 ′ of the guide pins 1640 inside the cam slot of the cutting tip 1632.
CT4′—Cutting tip 1632 completes rotation in a clockwise direction relative to guide pin 1640 inside cam slot 2016. Cutting tip 1632 is in the most retracted position within outer sheath assembly 1602.
CT5 '(not shown)-Cutting tip 1632 has not moved relative to position CT4'.
CT6'-guide pin 1640 is in a second home position within the cam slot 2016 of the cutting tip 1632 and the cutting tip 1632 is in a retracted position inside the outer sheath assembly 1602 (including the outer band 1636). .

  [00248] By continuing the first actuation of trigger 1508, trigger pin 1528 moves from position BC3 '(FIG. 22A) to position BC4'. By this action, the cylindrical cam cylinder 1520 and the cutting tip 1632 rotate by about 110 degrees in the clockwise direction. Also, due to this action, the trigger pin 1528 rotates the follower guide 1521 by about 110 degrees counterclockwise with respect to the cylindrical cam cylinder 1520. That is, the follower guide 1521 rotates from the first relative rotation prevention position to the second relative rotation prevention position. The follower guide 1521 ensures that in the second anti-rotation position, the trigger pin 1528 then advances straight through the intersection 1545 of the cam slot 1544 of the cylindrical cam cylinder 1520, intersecting its previous path. To be arranged.

  [00249] Trigger pin 1528 is moved distally (eg, by releasing trigger 1508) after reaching position BC4 '. By this action, the trigger pin 1528 moves from the position BC4 'to the position BC5' and then to the position BC6 '. When the trigger pin 1528 moves from the position BC5 'to the position BC6', the cylindrical cam cylinder 1520 and the cutting tip 1632 rotate about 33 degrees in the counterclockwise direction. Therefore, when the trigger pin 1528 moves from the position BC1 'to the position BC6', the cylindrical cam cylinder 1520 and the cutting tip 1632 are rotationally displaced by about 254 degrees in the clockwise direction. Trigger pin 1528 remains in its second home position, position BC6 ', until the clinician initiates a second actuation of trigger 1508.

[00250] Referring now to FIGS. 22B, 23E, and 23F, the following is a description of the positions BC7′-BC8 ′ of the trigger pin 1528 within the cam slot 1544 of the cylindrical cam cylinder 1520. At these positions, the follower guide 1521 is in the second relative rotation prevention position and rotates together with the cylindrical cam cylinder 1520.
BC7'-trigger pin 1528 has been moved longitudinally in the proximal direction, thereby rotating cylindrical cam cylinder 1520 in a counterclockwise direction. The trigger pin 1528 engages a wall 1569 extending on the second diagonal of the opening 1565 of the follower guide 1521.
BC8'-trigger pin 1528 has undergone further longitudinal movement in the proximal direction, thereby further rotating cylindrical cam cylinder 1520 in a counterclockwise direction. The trigger pin 1528 engages with a wall 1573 extending in the second longitudinal direction of the opening 1565 of the follower guide 1521.

[00251] Positions BC7 'to BC8' of the trigger pin 1528 inside the cam slot of the cylindrical cam cylinder 1520 correspond to positions CT7 'to CT8' of the guide pin 1640 inside the cam slot of the cutting tip 1632. The following is a description of the positions CT7 ′ to CT8 ′ of the guide pins 1640 inside the cam slot of the cutting tip 1632.
CT7′—Cutting tip 1632 has completed about half of a predetermined rotation in a counterclockwise direction relative to guide pin 1640 inside cam slot 2016. Cutting tip 1632 is in the most extended position, outside outer sheath assembly 1602.
CT 8 ′ —Cutting tip 1632 has undergone further rotation in a counterclockwise direction relative to guide pin 1640 inside cam slot 2016. The cutting tip 1632 is in an intermediate position between the extended position and the retracted position inside the outer sheath assembly 1602 or the retracted position inside the outer sheath assembly 1602.

  [00252] By starting the second operation of the trigger 1508 as described above, the trigger pin 1528 moves from its second home position BC6 'to the intersection 1545 (position BC7') of the cam slot 1544 of the cylindrical cam cylinder 1520. Move to. By this action, the cylindrical cam cylinder 1520 and the cutting tip 1632 rotate by 127 degrees in the counterclockwise direction. The trigger pin 1528 engages a wall 1569 extending in the second diagonal of the opening 1565 of the follower guide 1521 at position BC7 ′ so that the trigger pin 1528 passes straight through the intersection 1545 of the cam slot 1544 of the cylindrical cam cylinder 1520. Guarantee to go forward In other words, the trigger pin 1528 advances from the third leg 1551 of the cam slot 1544 to the fourth leg 1553 of the cam slot 1544. In other words, the follower guide 1521 ensures that the trigger pin 1528 traverses the second slot portion defined by the third leg 1551 and the fourth leg 1553. This ensures that the cylindrical cam cylinder 1520 continues to rotate in the counterclockwise direction. Engagement of the trigger pin 1528 with the wall of the opening 1565 of the follower guide 1521 tends to rotate the follower guide 1521 counterclockwise with respect to the cylindrical cam cylinder 1520. However, such movement is blocked by the relative rotation blocking mechanism 1575 in the second relative rotation blocking position.

  [00253] By continuing the second actuation of trigger 1508, trigger pin 1528 moves from position BC7 'to position BC8'. By this action, the cylindrical cam cylinder 1520 and the cutting tip 1632 are further rotated by 50 degrees in the counterclockwise direction. The trigger pin 1528 engages a wall 1573 extending in the second longitudinal direction of the opening 1565 of the follower guide 1521 at the position BC8 '. As described in more detail below, when the trigger pin 1528 moves past the position BC8 ', the follower guide 1521 rotates in a counterclockwise direction with respect to the cylindrical cam cylinder 1520.

[00254] Referring now to FIGS. 22C and 23A, the following is a description of the positions BC9′-BC10 ′ of the trigger pin 1528 within the cam slot of the cylindrical cam cylinder 1520. At these positions, the follower guide 1521 is in the first relative rotation prevention position and rotates together with the cylindrical cam cylinder 1520.
BC9'-trigger pin 1528 has completed almost all of its longitudinal movement in the proximal direction, and cylindrical cam cylinder 1520 has completed its counterclockwise rotation. The follower guide 1521 has been rotated back to the first relative rotation prevention position by the trigger pin 1528.
BC10′—Trigger pin 1528 has been moved longitudinally in the distal direction. The cylindrical cam cylinder 1520 remains stationary.

[00255] The positions BC9 'to BC10' of the trigger pin 1528 inside the cam slot of the cylindrical cam cylinder 1520 correspond to the positions CT9 'to CT10' of the guide pin 1640 inside the cam slot of the cutting tip 1632. The following is a description of the positions CT9′-CT10 ′ of the guide pins 1640 inside the cam slot of the cutting tip 1632.
CT9′—Cutting tip 1632 completes counterclockwise rotation relative to guide pin 1640 inside cam slot 2016. Cutting tip 1632 is in the most retracted position within outer sheath assembly 1602.
CT10 '(not shown)-Cutting tip 1632 has not moved relative to position CT9'.

  [00256] By continuing the second actuation of trigger 1508, trigger pin 1528 moves from position BC8 '(FIG. 22B) to position BC9'. By this action, the cylindrical cam cylinder 1520 and the cutting tip 1632 are further rotated by 110 degrees in the counterclockwise direction. Further, by this action, the trigger pin 1528 rotates the follower guide 1521 by 100 degrees in the clockwise direction with respect to the cylindrical cam cylinder 1520. That is, the follower guide 1521 rotates back from the second relative rotation prevention position to the first relative rotation prevention position. The follower guide 1521 again moves the trigger pin 1528 straight forward through the intersection 1545 of the cam slot 1544 of the cylindrical cam cylinder 1520, intersecting its previous path, in the first relative rotation blocking position. Arranged to guarantee.

  [00257] After trigger pin 1528 reaches position BC9 ', trigger 1508 is moved distally (eg, by releasing trigger 1508). By this action, the trigger pin 1528 moves from the position BC9 'to the position BC10' and then to the position BC1 '. When the trigger pin 1528 moves from the position BC10 'to the position BC1', the cylindrical cam cylinder 1520 and the cutting tip 1632 rotate by about 33 degrees in the clockwise direction. Therefore, when the trigger pin 1528 moves from the position BC6 'to the position BC1', the cylindrical cam cylinder 1520 and the cutting tip 1632 are rotationally displaced by about 254 degrees in the counterclockwise direction.

  [00258] Trigger pin 1528 remains in its first home position, position BC1 ', until the clinician initiates a third actuation of trigger 1508. As described above, additional “odd-numbered” actuations of trigger 1508 (ie, third actuation, fifth actuation, etc.) result in the same device motion as during the first actuation of trigger 1508, and trigger 1508 The additional “even-numbered” actuation (ie, fourth actuation, sixth actuation, etc.) results in the same device motion as during the second actuation of trigger 1508.

  [00259] Referring now to FIGS. 24-28, an exemplary cylindrical cam assembly 2419 is illustrated. The tubular cam assembly 2419 is used with a surgical device, such as the surgical device 1206 described above, instead of the tubular cam assembly 1519. The cylindrical cam assembly 2419 includes a cylindrical cam cylinder 2420 that conveys the follower guide 2421 rotatably. The cylindrical cam cylinder 2420 and follower guide 2421 can be any one of the cylindrical cam cylinder and follower guide described herein, with the exception of the relative rotation blocking mechanism (eg, cam groove 1544 and follower opening 1565, respectively). Have the same characteristics.

  [00260] The cylindrical cam assembly 2419 includes a relative rotation blocking mechanism 2475 that blocks some rotation of the follower guide 2421 relative to the cylindrical cam cylinder 2420. In general, the relative rotation prevention mechanism 2475 is configured such that the follower guide 2421 is moved from a first relative rotation prevention position (referred to as “first lock position” for simplicity) to a second relative rotation prevention position (for simplicity). (Referred to as “second locking position”) and vice versa. In the first locked position, the mechanism 2475 initially prevents the follower guide 2421 from rotating in the first direction (ie, toward the second locked position) relative to the cylindrical cam cylinder 2420, and then The follower guide 2421 is prevented from rotating in the second direction with respect to the cylindrical cam cylinder 2420. In the second locked position, the mechanism 2475 initially prevents the follower guide 2421 from rotating in the second direction (ie, toward the first locked position) relative to the cylindrical cam cylinder 2420, and then The follower guide 2421 is prevented from rotating in the first direction with respect to the cylindrical cam cylinder 2420.

  [00261] Relative rotation blocking mechanism 2475 includes a protrusion 2402 formed near the proximal end of cylindrical cam cylinder 2420 and projecting radially outward. The protrusion 2402 is formed on the cylindrical cam cylinder 2420 in the machining process. The protrusion 2402 includes a curved recess 2404 facing proximally. The protrusion 2402 also includes a first laterally facing engaging surface 2406 and a second laterally facing engaging surface 2408.

  [00262] Relative rotation blocking mechanism 2475 includes first spring pin 2410, second spring pin 2412 (see FIG. 25), first laterally facing engagement surface 2413, and follower guide 2421 proximal. Also included is a second laterally facing engagement surface 2414 (see FIG. 25) formed near the end. The spring pins 2410 and 2412 and the engagement surfaces 2413 and 2414 are formed on the follower guide 2421 by a laser cutting process.

  [00263] The first spring pin 2410 is cantilevered from the remainder of the follower guide 2421 and extends partially around the periphery of the follower guide 2421. The curved tip 2418 included in the first spring pin 2410 selectively engages the curved recess 2404 of the protrusion 2402 to prevent the follower guide 2421 from rotating relative to the cylindrical cam cylinder 2420. This aspect is described in more detail below. In some embodiments, the curved tip 2418 has a radius of about 0.040 inch and a 0.015 inch interference fit with the curved recess 2404 of the protrusion 2402. Such dimensions facilitate both fixing the first spring pin 2410 to the protrusion 2402 and sliding separation.

  [00264] The second spring pin 2412 is cantilevered from the rest of the follower guide 2421. The second spring pin 2412 extends partially around the periphery of the follower guide 2421 and faces the first spring pin 2410 in a circumferential direction. A curved tip 2422 included in the second spring pin 2412 selectively engages with the curved recess 2404 of the protrusion 2402 to prevent the follower guide 2421 from rotating relative to the cylindrical cam cylinder 2420. This aspect is described in more detail below. In some embodiments, the curved tip 2422 has a radius of about 0.040 inch and a 0.015 inch interference fit with the curved recess 2404 of the protrusion 2402. Such a dimension facilitates both fixing and sliding separation of the second spring pin 2412 with respect to the protrusion 2402.

  [00265] The interaction of the first and second spring pins 2410, 2412 and the protrusions 2402 and the resulting movement of the follower guide 2421 relative to the cylindrical cam cylinder 2420 is illustrated in FIGS. 22A-22C. This will be described with reference to the cam slot and the opening profile. Referring first to FIG. 22A, during the first actuation of the trigger assembly, the trigger pin initially moves from position BC1 'to BC3'. When the trigger pin moves in this manner, the follower guide 2421 rotates together with the cylindrical cam cylinder 2420 because the curved tip 2418 of the first spring pin 2410 is engaged with the curved recess 2404 of the protrusion 2402. In other words, the first spring pin 2410 engages the protrusion 2402 to initially maintain the follower guide 2421 in the first locked position relative to the cylindrical cam cylinder 2420.

  [00266] Referring to FIG. 22B, continuing the first actuation of the trigger assembly moves the trigger pin from position BC3 'to BC4'. The trigger pin engages the wall of the follower guide opening at position BC3 '. By applying force to the follower guide 2421 by moving the trigger pin toward the position BC 4 ′, the curved tip 2418 of the first spring pin 2410 slips and separates from the curved recess 2404 of the protrusion 2402. As a result, the follower guide 2421 is “unlocked” and rotates relative to the cylindrical cam cylinder 2420 when the trigger pin moves from position BC3 ′ to BC4 ′. As the trigger pin approaches position BC4 ', the curved tip 2422 of the second spring pin 2412 slips into engagement with the curved recess 2404 of the protrusion 2402. Accordingly, the follower guide 2421 enters the second lock position with respect to the cylindrical cam cylinder 2420.

  [00267] When the user releases the trigger assembly, the trigger pin moves from position BC4 'to BC6'. When the trigger pin moves in this manner, the follower guide 2421 rotates together with the cylindrical cam cylinder 2420 because the curved tip 2422 of the second spring pin 2412 is engaged with the curved recess 2404 of the protrusion 2402. In other words, after the first actuation of the trigger assembly, the second spring pin 2412 engages the protrusion 2402 to maintain the follower guide 2421 in the second locked position relative to the cylindrical cam cylinder 2420.

  [00268] Still referring to FIG. 22B, upon a second actuation of the trigger assembly, the trigger pin initially moves from position BC6 'to BC8'. When the trigger pin moves in this manner, the follower guide 2421 rotates together with the cylindrical cam cylinder 2420 because the curved tip 2422 of the second spring pin 2412 is engaged with the curved recess 2404 of the protrusion 2402. In other words, the second spring pin 2412 engages the protrusion 2402 to initially maintain the follower guide 2421 in a second locked position relative to the cylindrical cam cylinder 2420.

  [00269] Referring to FIG. 22C, continuing the second actuation of the trigger assembly moves the trigger pin from position BC8 'to BC9'. The trigger pin engages the wall of the follower guide opening at position BC8 '. By applying force to the follower guide 2421 by moving the trigger pin toward the position BC 9 ′, the curved tip 2422 of the second spring pin 2412 slips and separates from the curved recess 2404 of the protrusion 2402. As a result, the follower guide 2421 is “unlocked” and rotates relative to the cylindrical cam cylinder 2420 when the trigger pin moves from position BC8 ′ to BC9 ′. As the trigger pin approaches position BC9 ', the curved tip 2418 of the first spring pin 2410 slips into engagement with the curved recess 2404 of the protrusion 2402. Accordingly, the follower guide 2421 returns to the first lock position with respect to the cylindrical cam cylinder 2420.

  [00270] When the user releases the trigger assembly, the trigger pin moves from position BC9 'to BC1'. When the trigger pin moves in this manner, the follower guide 2421 rotates together with the cylindrical cam cylinder 2420 because the curved tip 2418 of the first spring pin 2410 is engaged with the curved recess 2404 of the protrusion 2402. In other words, after the second actuation of the trigger assembly, the first spring pin 2410 engages the protrusion 2402 to maintain the follower guide 2421 in the first locked position relative to the cylindrical cam cylinder 2420.

  In addition, as shown in FIG. 24, the first engagement surface 2413 of the follower guide 2421 engages with the first engagement surface 2406 of the protrusion 2402 in the first locked position, and the follower The guide 2421 is prevented from rotating in the direction away from the second lock position. The second engagement surface 2414 of the follower guide 2421 engages with the second engagement surface 2408 of the protrusion 2402 at the second lock position, and the follower guide 2421 rotates in a direction away from the first lock position. To prevent it.

  [00272] Referring now to FIGS. 29-30, an exemplary cylindrical cam assembly 2919 is illustrated. The tubular cam assembly 2919 is used with a surgical device, such as the surgical device 1206 described above, instead of the tubular cam assembly 1519. The cylindrical cam assembly 2919 includes a cylindrical cam cylinder 2920 that conveys the follower guide 2921 rotatably. The cylindrical cam cylinder 2920 and follower guide 2921 can be any of the cylindrical cam cylinder and follower guide described herein, with the exception of the relative rotation blocking mechanism (eg, cam groove 1544 and follower opening 1565, respectively). Have the same characteristics.

  [00273] The cylindrical cam assembly 2919 includes a relative rotation blocking mechanism 2975 that blocks some rotation of the follower guide 2921 relative to the cylindrical cam cylinder 2920. In general, the relative rotation prevention mechanism 2975 is configured such that the follower guide 2921 moves from a first relative rotation prevention position (referred to as “first lock position” for simplicity) to a second relative rotation prevention position (for simplicity). (Referred to as “second locking position”) and vice versa. In the first locked position, the mechanism 2975 initially prevents the follower guide 2921 from rotating in the first direction (ie, toward the second locked position) relative to the cylindrical cam cylinder 2920, and then The follower guide 2921 is prevented from rotating in the second direction with respect to the cylindrical cam cylinder 2920. In the second locked position, the mechanism 2975 initially prevents the follower guide 2921 from rotating in the second direction (ie, toward the first locked position) relative to the cylindrical cam cylinder 2920, and then The follower guide 2921 is prevented from rotating in the first direction with respect to the cylindrical cam cylinder 2920.

  [00274] Relative rotation blocking mechanism 2975 includes a radially outwardly projecting protrusion 2902 that is conveyed near the proximal end of cylindrical cam cylinder 2920. Pin 2902 is coupled to cylindrical cam cylinder 2920 in various ways. For example, the pin 2902 is press-fitted into or glued to a hole formed on the cylindrical cam cylinder 2920. In some embodiments, the relative rotation prevention mechanism 2975 also includes a radially outwardly curved recess 2904 formed near the proximal end of the cylindrical cam cylinder 2920. The curved recess 2904 is offset from the pin 2902 at an angle around the longitudinal axis of the cylindrical cam cylinder 2920.

  [00275] The relative rotation blocking mechanism 2975 includes a spring arm 2908, a first laterally facing engagement surface 2913, and a second laterally facing engagement formed near the proximal end of the follower guide 2921. A surface 2914 is also included.

  [00276] The spring arm 2908 is a cantilever from the remainder of the follower guide 2921 at the first end. Spring arm 2908 includes a radially inwardly curved finger 2910 at the opposite end. The finger 2910 selectively engages with the curved recess 2904 of the cylindrical cam cylinder 2920 to prevent rotation of the follower guide 2921 relative to the cylindrical cam cylinder 2920. This aspect is described in more detail below.

  [00277] The interaction of the spring arm 2908 and the cylindrical cam cylinder 2920 and the resulting movement of the follower guide 2921 relative to the cylindrical cam cylinder 2920 refer to the cam slot and opening profiles shown in FIGS. 22A-22C. Explained. Referring first to FIG. 22A, during the first actuation of the trigger assembly, the trigger pin initially moves from position BC1 'to BC3'. When the trigger pin moves in this way, the follower guide 2921 rotates with the cylindrical cam cylinder 2920 because the finger 2910 is engaged with the curved recess 2904 of the cylindrical cam cylinder 2920. In other words, the finger 2910 engages the curved recess 2904 to initially maintain the follower guide 2921 in a first locked position relative to the cylindrical cam cylinder 2920.

  [00278] Referring to FIG. 22B, continuing the first actuation of the trigger assembly moves the trigger pin from position BC3 'to BC4'. The trigger pin engages the wall of the follower guide opening at position BC3 '. When the trigger pin moves toward the position BC 4 ′ and applies force to the follower guide 2921, the finger 2910 slips and separates from the curved recess 2904 of the cylindrical cam cylinder 2920. As a result, the follower guide 2921 is “unlocked” and rotates relative to the cylindrical cam cylinder 2920 when the trigger pin moves from position BC3 ′ to BC4 ′. Finger 2910 slips and engages with the outer surface of cylindrical cam cylinder 2920 when follower guide 2921 rotates relative to cylindrical cam cylinder 2920. As the trigger pin approaches position BC 4 ′, finger 2910 remains engaged with curved recess 2904 of cylindrical cam cylinder 2920. Accordingly, the follower guide 2921 enters the second lock position with respect to the cylindrical cam cylinder 2920.

  [00279] When the user releases the trigger assembly, the trigger pin moves from position BC4 'to BC6'. When the trigger pin moves in this manner, the follower guide 2921 rotates together with the cylindrical cam cylinder 2920 because the finger 2910 is engaged with the outer surface of the cylindrical cam cylinder 2920. In other words, after the first actuation of the trigger assembly, the finger 2910 is positioned on the outer surface of the cylindrical cam cylinder 2920 so as to maintain the follower guide 2921 in a second locked position relative to the cylindrical cam cylinder 2920. It remains engaged.

  [00280] Still referring to FIG. 22B, upon a second actuation of the trigger assembly, the trigger pin initially moves from position BC6 'to BC8'. When the trigger pin moves in this manner, the follower guide 2921 rotates with the cylindrical cam cylinder 2920 because of the frictional force between the finger 2910 and the outer surface of the cylindrical cam cylinder 2920. In other words, the finger 2910 engages the outer surface of the cylindrical cam cylinder 2920 so as to initially maintain the follower guide 2921 in the second locked position relative to the cylindrical cam cylinder 2920.

  [00281] Referring to FIG. 22C, continuing the second actuation of the trigger assembly moves the trigger pin from position BC8 'to BC9'. The trigger pin engages the wall of the follower guide opening at position BC8 '. The trigger pin moves toward the position BC <b> 9 ′ to apply a force to overcome the frictional force between the finger 2910 and the outer surface of the cylindrical cam cylinder 2920 to the follower guide 2921. As a result, the finger 2910 slips against the outer surface of the cylindrical cam cylinder 2920 and the follower guide 2921 is “unlocked” so that the trigger pin moves from position BC8 ′ to BC9 ′ relative to the cylindrical cam cylinder 2920. Rotate. When the trigger pin approaches position BC 9 ′, finger 2910 slips and engages with the curved recess 2904 of cylindrical cam cylinder 2920. As a result, the follower guide 2921 returns to the first lock position with respect to the cylindrical cam cylinder 2920.

  [00282] When the user releases the trigger assembly, the trigger pin moves from position BC9 'to BC1'. When the trigger pin moves in this way, the follower guide 2921 rotates with the cylindrical cam cylinder 2920 because the finger 2910 is engaged with the curved recess 2904 of the cylindrical cam cylinder 2920. In other words, after the second actuation of the trigger assembly, finger 2910 engages pin 2902 to maintain follower guide 2921 in a first locked position relative to cylindrical cam cylinder 2920.

  In addition, as shown in FIG. 29, the first engagement surface 2913 of the follower guide 2921 is engaged with the pin 2902 of the cylindrical cam cylinder 2920 in the first locked position, and the follower guide 2921 is engaged. Is prevented from rotating in a direction away from the second locked position. The second engagement surface 2914 of the follower guide 2921 engages with the pin 2902 in the second locked position, and prevents the follower guide 2921 from rotating in a direction away from the first locked position.

  [00284] In some embodiments, a second radially outwardly curved recess (not shown) included in the cylindrical cam cylinder 2920 causes the finger 2910 to be in the second locked position of the follower guide 2921. receive. In some embodiments, the cylindrical cam cylinder 2920 does not have a radially outwardly recessed recess. Instead, the finger 2910 remains engaged with the outer surface of the cylindrical cam cylinder 2920 in the first locked position, the second locked position, and the unlocked position.

  [00285] Referring now to FIG. 31, an exemplary cylindrical cam assembly 3119 is illustrated. The tubular cam assembly 3119 is used with a surgical device, such as the surgical device 1206 described above, instead of the tubular cam assembly 1519. The cylindrical cam assembly 3119 includes a cylindrical cam cylinder 3120 that conveys the follower guide 3121 rotatably. The cylindrical cam cylinder 3120 and follower guide 3121 may be any of the cylindrical cam cylinder and follower guide described herein, with the exception of the relative rotation prevention mechanism (eg, cam groove 1544 and follower opening 1565, respectively). Have the same characteristics.

  The cylindrical cam assembly 3119 includes a relative rotation prevention mechanism 3175 that prevents some rotation of the follower guide 3121 with respect to the cylindrical cam cylinder 3120. In general, the relative rotation prevention mechanism 3175 is configured such that the follower guide 3121 is moved from a first relative rotation prevention position (referred to as “first lock position” for simplicity) to a second relative rotation prevention position (for simplicity). (Referred to as “second locking position”) and vice versa. In the first locked position, the mechanism 3175 initially prevents the follower guide 3121 from rotating in the first direction relative to the cylindrical cam cylinder 3120 (ie, toward the second locked position), and then The follower guide 3121 is prevented from rotating in the second direction with respect to the cylindrical cam cylinder 3120. In the second locked position, the mechanism 3175 initially prevents the follower guide 3121 from rotating in the second direction relative to the cylindrical cam cylinder 3120 (ie, toward the first locked position), and then The follower guide 3121 is prevented from rotating in the first direction with respect to the cylindrical cam cylinder 3120.

  [00287] Relative rotation blocking mechanism 3175 includes a projecting pin 3102 that projects radially outward and is conveyed near the proximal end of cylindrical cam cylinder 3120. The pin 3102 is coupled to the cylindrical cam cylinder 3120 in various ways. For example, the pin 3102 is press-fitted into a hole formed on the cylindrical cam cylinder 3120 or bonded.

  [00288] The relative rotation prevention mechanism 3175 also includes a first spherical element 3108 and a second spherical element 3110. The first spherical element 3108 and the second spherical element 3110 are fixedly accommodated in a cylindrical blind hole formed on the outer surface of the cylindrical cam cylinder 3120. The first spherical element 3108 and the second spherical element 3110 protrude from this hole and engage with the inner surface of the follower guide 3121. Therefore, the first spherical element 3108 and the second spherical element 3110 promote frictional engagement between the cylindrical cam cylinder 3120 and the follower guide 3121.

  [00289] In some embodiments, the first spherical element 3108 and the second spherical element 3110 are press fit into a hole on the cylindrical cam cylinder 3120. In some embodiments, the first spherical element 3108 and the second spherical element 3110 are disposed near the proximal and distal ends of the cylindrical cam cylinder 3120, respectively. In some embodiments, the first spherical element 3108 and the second spherical element 3110 are formed from steel, polyethylene, or the like. In some embodiments, the first spherical element 3108 and the second spherical element 3110 are similar to ball bearing rolling elements or balls.

  [00290] Relative rotation blocking mechanism 3175 has a first laterally facing engagement surface 3113 and a second laterally-facing engagement surface 3114 formed near the proximal end of follower guide 3121. In addition.

  [00291] In some embodiments, the relative rotation prevention mechanism 3175 further includes a through hole 3112 formed on the follower guide 3121. The through hole 3112 has a diameter that is smaller than the diameter of the first spherical element 3108. The through hole 3112 receives the first spherical element 3108 at the first locked position of the follower guide 3121. When the first spherical element 3108 enters the through hole 3112, tactile feedback is provided to the user of the device.

  [00292] The interaction between the first spherical element 3108 and the second spherical element 3110 and the follower guide 3121 and the resulting movement of the follower guide 3121 relative to the cylindrical cam cylinder 3120 are illustrated in FIGS. 22A-22C. This will be described with reference to the cam slot and opening profile shown. Referring first to FIG. 22A, during the first actuation of the trigger assembly, the trigger pin initially moves from position BC1 'to BC3'. When the trigger pin moves in this way, the follower guide 3121 rotates together with the cylindrical cam cylinder 3120 by the friction force between the first spherical element 3108 and the second spherical element 3110 and the follower guide 3121. In other words, the first spherical element 3108 and the second spherical element 3110 maintain the follower guide 3121 initially in the first locked position relative to the cylindrical cam cylinder 3120.

  [00293] Referring to FIG. 22B, continuing the first actuation of the trigger assembly moves the trigger pin from position BC3 'to BC4'. The trigger pin engages the wall of the follower guide opening at position BC3 '. The trigger pin moves toward the position BC <b> 4 ′ and applies a force to the follower guide 3121 to overcome the frictional force between the first spherical element 3108 and the second spherical element 3110 and the follower guide 3121. As a result, the first spherical element 3108 and the second spherical element 3110 slip relative to the follower guide 3121 and the follower guide 3121 is “unlocked” so that the cylinder moves when the trigger pin moves from position BC3 ′ to BC4 ′. The cam cylinder 3120 rotates. The trigger pin no longer applies force to the follower guide 3121 when it reaches position BC4 '.

  [00294] When the user releases the trigger assembly, the trigger pin moves from position BC4 'to BC6'. When the trigger pin moves in this way, the follower guide 3121 rotates together with the cylindrical cam cylinder 3120 by the friction force between the first spherical element 3108 and the second spherical element 3110 and the follower guide 3121. In other words, after the first actuation of the trigger assembly, the first spherical element 3108 and the second spherical element 3110 maintain the follower guide 3121 in a second locked position relative to the cylindrical cam cylinder 3120.

  [00295] Still referring to FIG. 22B, upon a second actuation of the trigger assembly, the trigger pin initially moves from position BC6 'to BC8'. When the trigger pin moves in this way, the follower guide 3121 rotates together with the cylindrical cam cylinder 3120 by the friction force between the first spherical element 3108 and the second spherical element 3110 and the follower guide 3121. In other words, the first spherical element 3108 and the second spherical element 3110 maintain the follower guide 3121 initially in the second locked position relative to the cylindrical cam cylinder 3120.

  [00296] Referring to FIG. 22C, continuing the second actuation of the trigger assembly moves the trigger pin from position BC8 'to BC9'. The trigger pin engages the wall of the follower guide opening at position BC8 '. The trigger pin moves toward the position BC <b> 9 ′ and applies a force to the follower guide 3121 to overcome the frictional force between the first spherical element 3108 and the second spherical element 3110 and the follower guide 3121. As a result, the first spherical element 3108 and the second spherical element 3110 slip relative to the follower guide 3121 and the follower guide 3121 is “unlocked” so that the cylinder moves when the trigger pin moves from position BC8 ′ to BC9 ′. The cam cylinder 3120 rotates. The trigger pin no longer applies force to the follower guide 3121 when it reaches position BC9 '.

  [00297] When the user releases the trigger assembly, the trigger pin moves from position BC9 'to BC1'. When the trigger pin moves in this way, the follower guide 3121 rotates together with the cylindrical cam cylinder 3120 by the friction force between the first spherical element 3108 and the second spherical element 3110 and the follower guide 3121. In other words, after the second actuation of the trigger assembly, the first spherical element 3108 and the second spherical element 3110 maintain the follower guide 3121 in a first locked position relative to the cylindrical cam cylinder 3120.

  In addition, as shown in FIG. 31, the first engagement surface 3113 of the follower guide 3121 is engaged with the pin 3102 of the cylindrical cam cylinder 3120 in the first locked position, and the follower guide 3121 is engaged. Is prevented from rotating in a direction away from the second locked position. The second engagement surface 3114 of the follower guide 3121 engages with the pin 3102 in the second lock position, and prevents the follower guide 3121 from rotating in a direction away from the first lock position.

  [00299] In some embodiments, the cylindrical cam assembly 3119 includes one spherical element or more than two spherical elements. In some embodiments, one or more of the spherical element 3108 and / or the spherical element 3110 are in a through hole formed on the follower guide 3121 in the first locked position and / or the second locked position. Be contained. Entering the spherical element in the through hole provides tactile feedback to the user of the device.

  [00300] Referring now to FIG. 32, an exemplary cylindrical cam assembly 3219 is illustrated. The tubular cam assembly 3219 is used with a surgical device, such as the surgical device 1206 described above, instead of the tubular cam assembly 1519. The cylindrical cam assembly 3219 includes a cylindrical cam cylinder 3220 that conveys the follower guide 3221 rotatably. The cylindrical cam cylinder 3220 and follower guide 3221 may be any one of the cylindrical cam cylinder and follower guide described herein, with the exception of the relative rotation prevention mechanism (eg, cam groove 1544 and follower opening 1565, respectively). Have the same characteristics.

  [00301] The cylindrical cam assembly 3219 includes a relative rotation blocking mechanism 3275 that blocks some rotation of the follower guide 3221 relative to the cylindrical cam cylinder 3220. In general, the relative rotation prevention mechanism 3275 is configured such that the follower guide 3221 is moved from a first relative rotation prevention position (referred to as “first lock position” for simplicity) to a second relative rotation prevention position (for simplicity). (Referred to as “second locking position”) and vice versa. In the first locked position, the mechanism 3275 initially prevents the follower guide 3221 from rotating in the first direction relative to the cylindrical cam cylinder 3220 (ie, toward the second locked position), and then The follower guide 3221 is prevented from rotating in the second direction with respect to the cylindrical cam cylinder 3220. In the second locked position, the mechanism 3275 initially prevents the follower guide 3221 from rotating in the second direction (ie, toward the first locked position) relative to the cylindrical cam cylinder 3220, and then The follower guide 3221 is prevented from rotating in the first direction with respect to the cylindrical cam cylinder 3220.

  [00302] Relative rotation blocking mechanism 3275 includes a longitudinally extending tab 3277 formed near the proximal end of follower guide 3221. Tab 3277 engages a semi-annular flange 3279 formed near the proximal end of cylindrical cam cylinder 3220. As shown in FIG. 31, the tab 3277 engages one surface of the flange 3279 in the first locked position to prevent the follower guide 3221 from rotating in a direction away from the second locked position. The tab 3277 engages with the other surface of the flange 3279 in the second locked position to prevent the follower guide 3221 from rotating in a direction away from the first locked position.

  [00303] The relative rotation prevention mechanism 3275 also includes a friction element 3208 that is fixedly conveyed by the cylindrical cam cylinder 3220. The friction element 3208 engages the follower guide 3221 to provide a frictional engagement between the cylindrical cam cylinder 3220 and the follower guide 3221. In some embodiments, the friction element 3208 is formed of Teflon, polyethylene, nylon, or the like. In some embodiments, the friction element 3208 has a disc shape, a spring washer shape, or a wave washer shape. In some embodiments, the friction element 3208 is glued to the cylindrical cam cylinder 3220.

  [00304] The interaction between the friction element 3208 and the follower guide 3221 and the resulting movement of the follower guide 3221 relative to the cylindrical cam cylinder 3220 refer to the cam slot and opening profiles shown in FIGS. 22A-22C. Explained. Referring first to FIG. 22A, during the first actuation of the trigger assembly, the trigger pin initially moves from position BC1 'to BC3'. When the trigger pin moves in this way, the follower guide 3221 rotates together with the cylindrical cam cylinder 3220 by the frictional force between the friction element 3208 and the follower guide 3221. In other words, the friction element 3208 initially maintains the follower guide 3221 in the first locked position relative to the cylindrical cam cylinder 3220.

  [00305] Referring to FIG. 22B, continuing the first actuation of the trigger assembly moves the trigger pin from position BC3 'to BC4'. The trigger pin engages the wall of the follower guide opening at position BC3 '. The trigger pin moves toward the position BC <b> 4 ′ and applies a force to the follower guide 3221 to overcome the frictional force between the friction element 3208 and the follower guide 3221. As a result, the friction element 3208 slips relative to the follower guide 3221 and the follower guide 3221 is “unlocked” and rotates relative to the cylindrical cam cylinder 3220 as the trigger pin moves from position BC3 ′ to BC4 ′. The trigger pin no longer applies force to the follower guide 3221 when reaching the position BC4 '.

  [00306] When the user releases the trigger assembly, the trigger pin moves from position BC4 'to BC6'. When the trigger pin moves in this way, the follower guide 3221 rotates together with the cylindrical cam cylinder 3220 by the frictional force between the friction element 3208 and the follower guide 3221. In other words, after the first actuation of the trigger assembly, the friction element 3208 maintains the follower guide 3221 in a second locked position relative to the cylindrical cam cylinder 3220.

  [00307] Still referring to FIG. 22B, upon a second actuation of the trigger assembly, the trigger pin initially moves from position BC6 'to BC8'. When the trigger pin moves in this way, the follower guide 3221 rotates together with the cylindrical cam cylinder 3220 by the frictional force between the friction element 3208 and the follower guide 3221. In other words, the friction element 3208 initially maintains the follower guide 3221 in the second locked position relative to the cylindrical cam cylinder 3220.

  [00308] Referring to FIG. 22C, continuing the second actuation of the trigger assembly causes the trigger pin to move from position BC8 'to BC9'. The trigger pin engages the wall of the follower guide opening at position BC8 '. The trigger pin moves toward the position BC <b> 9 ′ and applies a force to the follower guide 3221 to overcome the frictional force between the friction element 3208 and the follower guide 3221. As a result, the friction element 3208 slips relative to the follower guide 3221 and the follower guide 3221 is “unlocked” and rotates relative to the cylindrical cam cylinder 3220 as the trigger pin moves from position BC8 ′ to BC9 ′. The trigger pin no longer applies force to the follower guide 3221 when it reaches position BC9 '.

  [00309] When the user releases the trigger assembly, the trigger pin moves from position BC9 'to BC1'. When the trigger pin moves in this way, the follower guide 3221 rotates together with the cylindrical cam cylinder 3220 by the frictional force between the friction element 3208 and the follower guide 3221. In other words, after the second actuation of the trigger assembly, the friction element 3208 maintains the follower guide 3221 in a first locked position relative to the cylindrical cam cylinder 3220.

  [00310] In some embodiments, the cylindrical cam cylinder 3220 transports a plurality of friction elements in a fixed manner. In some embodiments, the follower guide 3221 fixedly conveys one or more friction elements that engage the outer surface of the cylindrical cam cylinder 3220.

  [00311] Referring now to FIGS. 33 and 34, an exemplary cylindrical cam assembly 3319 is illustrated. The tubular cam assembly 3319 is used with a surgical device, such as the surgical device 1206 described above, instead of the tubular cam assembly 1519. The cylindrical cam assembly 3319 includes a cylindrical cam cylinder 3320 that conveys the follower guide 3321 rotatably. The cylindrical cam cylinder 3320 and follower guide 3321 may be any one of the cylindrical cam cylinder and follower guide described herein, with the exception of the relative rotation prevention mechanism (eg, cam groove 1544 and follower opening 1565, respectively). Have the same characteristics.

  [00312] The cylindrical cam assembly 3319 includes a relative rotation blocking mechanism 3375 that blocks some rotation of the follower guide 3321 relative to the cylindrical cam cylinder 3320. In general, the relative rotation prevention mechanism 3375 is configured such that the follower guide 3321 moves from a first relative rotation prevention position (referred to as “first lock position” for simplicity) to a second relative rotation prevention position (for simplicity). (Referred to as “second locking position”) and vice versa. In the first locked position, the mechanism 3375 initially prevents the follower guide 3321 from rotating in the first direction relative to the cylindrical cam cylinder 3320 (ie, toward the second locked position), and then The follower guide 3321 is prevented from rotating in the second direction with respect to the cylindrical cam cylinder 3320. In the second locked position, the mechanism 3375 initially prevents the follower guide 3321 from rotating relative to the cylindrical cam cylinder 3320 in the second direction (ie, toward the first locked position), and then The follower guide 3321 is prevented from rotating in the first direction with respect to the cylindrical cam cylinder 3320.

  [00313] Relative rotation blocking mechanism 3375 includes a longitudinally extending tab 3377 formed near the proximal end of follower guide 3321. Tab 3377 engages a semi-annular flange 3379 formed near the proximal end of cylindrical cam cylinder 3320. As shown in FIGS. 33 and 34, the tab 3377 engages with one surface of the flange 3379 in the first locked position, so that the follower guide 3321 rotates in a direction away from the second locked position. Stop. Tab 3377 engages the other surface of flange 3379 in the second locked position to prevent follower guide 3321 from rotating away from the first locked position.

  [00314] The relative rotation blocking mechanism 3375 also includes a first magnetic element 3308 that is conveyed in a fixed manner by a cylindrical cam cylinder 3320. The first magnetic element 3308 is a magnet or is formed from one or more ferromagnetic materials (eg, steel) that are attracted to the magnet. The relative rotation blocking mechanism 3375 further includes a second magnetic element 3310 and a third magnetic element 3312 that are transported fixedly by the follower guide 3321. The second magnetic element 3310 and the third magnetic element 3312 are magnets or, if the first magnetic element 3308 is a magnet, one or more ferromagnetic materials (eg, steel) that are attracted to the magnet. ).

  [00315] The interaction of the first magnetic element 3308 with the second magnetic element 3310 and the third magnetic element 3312 and the resulting movement of the follower guide 3321 relative to the cylindrical cam cylinder 3320 is illustrated in FIGS. This will be described with reference to the cam slot and opening profile shown in FIG. 22C. Referring first to FIG. 22A, during the first actuation of the trigger assembly, the trigger pin initially moves from position BC1 'to BC3'. When the trigger pin moves in this way, the follower guide 3321 rotates together with the cylindrical cam cylinder 3320 by the magnetic attractive force between the first magnetic element 3308 and the second magnetic element 3310. In other words, the first magnetic element 3308 and the second magnetic element 3310 initially maintain the follower guide 3321 in the first locked position relative to the cylindrical cam cylinder 3320.

  [00316] Referring to FIG. 22B, continuing the first actuation of the trigger assembly moves the trigger pin from position BC3 'to BC4'. The trigger pin engages the wall of the follower guide opening at position BC3 '. The trigger pin moves toward the position BC 4 ′ to apply a force to the follower guide 3321 that overcomes the magnetic attraction between the first magnetic element 3308 and the second magnetic element 3310. As a result, when the first magnetic element 3308 and the second magnetic element 3310 move and separate, the follower guide 3321 is “unlocked” and the trigger pin moves from position BC3 ′ to position BC4 ′, the cylindrical cam cylinder Rotate relative to 3320. As the trigger pin approaches position BC4 ', the first magnetic element 3308 and the third magnetic element 3312 are magnetically attracted to each other. Accordingly, the follower guide 3321 enters a second lock position with respect to the cylindrical cam cylinder 3320.

  [00317] When the user releases the trigger assembly, the trigger pin moves from position BC4 'to BC6'. When the trigger pin moves in this way, the follower guide 3321 rotates together with the cylindrical cam cylinder 3320 by the magnetic attractive force between the first magnetic element 3308 and the third magnetic element 3312. In other words, after the first actuation of the trigger assembly, the first magnetic element 3308 and the third magnetic element 3312 maintain the follower guide 3321 in a second locked position relative to the cylindrical cam cylinder 3320.

  [00318] Still referring to FIG. 22B, upon a second actuation of the trigger assembly, the trigger pin initially moves from position BC6 'to BC8'. When the trigger pin moves in this way, the follower guide 3321 rotates together with the cylindrical cam cylinder 3320 by the magnetic attractive force between the first magnetic element 3308 and the third magnetic element 3312. In other words, the first magnetic element 3308 and the third magnetic element 3312 initially maintain the follower guide 3321 in the second locked position relative to the cylindrical cam cylinder 3320.

  [00319] Referring to FIG. 22C, continuing the second actuation of the trigger assembly moves the trigger pin from position BC8 'to BC9'. The trigger pin engages the wall of the follower guide opening at position BC8 '. The trigger pin moves toward the position BC <b> 9 ′ to apply a force to the follower guide 3321 to overcome the magnetic attraction between the first magnetic element 3308 and the third magnetic element 3312. As a result, the cylindrical cam cylinder is moved when the first magnetic element 3308 and the third magnetic element 3312 are moved apart and the follower guide 3321 is “unlocked” and the trigger pin moves from the position BC8 ′ to BC9 ′. Rotate relative to 3320. As the trigger pin approaches position BC9 ', the first magnetic element 3308 and the second magnetic element 3310 are magnetically attracted to each other. Accordingly, the follower guide 3321 returns to the first lock position with respect to the cylindrical cam cylinder 3320.

  [00320] When the user releases the trigger assembly, the trigger pin moves from position BC9 'to BC1'. When the trigger pin moves in this way, the follower guide 3321 rotates together with the cylindrical cam cylinder 3320 by the magnetic attractive force between the first magnetic element 3308 and the second magnetic element 3310. In other words, after the second actuation of the trigger assembly, the first magnetic element 3308 and the second magnetic element 3310 maintain the follower guide 3321 in a first locked position relative to the cylindrical cam cylinder 3320.

  [00321] In some embodiments, the follower guide 3321 carries one magnetic element and the cylindrical cam cylinder 3320 carries two magnetic elements.

  [00322] FIG. 35 illustrates a cutting tip slot 3516 profile, a cylindrical cam slot 3544 profile, a cutting tip portion, a cylindrical cam cylinder, and a follower guide, respectively, described herein. FIG. 6 represents a two-dimensional view with the profile of the aperture 3565 of the follower guide formed on top of any. 36A-36C show that actuation of the trigger (any trigger described herein) and the resulting movement of the trigger pin 3528 (any trigger pin described herein) is a cylindrical cam cylinder. FIG. 2 illustrates a state in which a rotational motion of a follower guide and a cutting tip and a translational motion of the cutting tip are brought about. In these figures, the horizontal axis of the profile of the slots 3516 and 3544 is the rotation (degree) of the cutting tip and the cylindrical cam cylinder. The vertical axis of the profile of the cutting tip cam slot 3516 is the amount of displacement (if any) in the longitudinal direction of the cutting tip. The vertical axis of the profile of the cam slot 3544 of the cylindrical cam cylinder is the amount of displacement in the longitudinal direction of the trigger assembly (and trigger pin).

  [00323] In FIGS. 35A-35C, the follower guide opening 3565 is shown as a dashed line and is positioned on the profile of the cam slot 3544 of the cylindrical cam cylinder to indicate the rotational position of the opening 3565 relative to the cam slot 3544. . As shown in FIGS. 35A-35C and described in more detail below, the rotational position of the opening 3565 relative to the cam slot 3544 changes during actuation of the trigger.

  [00324] Generally, by the initial actuation of the trigger, ie, the first actuation (ie, pulling the trigger to the extent that the handle assembly permits, and then releasing the trigger back to its home position), the cutting tip This results in a net rotational displacement of about 254 degrees in one direction (clockwise when looking at the tip from the handle) in the part and cylindrical cam cylinder. Also, with the first actuation, the cutting tip extends from the outer band and then returns to the retracted position as it rotates. Subsequent actuation of the trigger, or second actuation, results in the cutting tip and the cylindrical cam cylinder having a net of about 254 degrees in the opposite direction (counterclockwise when viewing the tip from the handle). Rotational displacement occurs. Also, the second operation causes the cutting tip to extend from the outer band and then return to the retracted position as it rotates. Additional “odd-numbered” actuations (ie, third actuation, fifth actuation, etc.) result in the same device motion as during the first actuation of the trigger. Additional “even-numbered” actuations (ie, fourth actuation, sixth actuation, etc.) result in the same device motion as during the second actuation of the trigger.

  [00325] Referring particularly to FIG. 36A, prior to the first actuation of the trigger, the trigger pin is in a first home position (BC1 ″) within the cylindrical cam cylinder and the guide pin is in its initial position (CT1). ''), The cutting tip is in the retracted position inside the outer sheath. In addition, the follower guide is in its first relative rotation blocking position (GS1 ″) relative to the cylindrical cam cylinder. When starting the first actuation of the trigger, the trigger pin moves proximally, and the tubular cam cylinder, cutting tip, and follower guide rotate clockwise (from the proximal view of the tubular cam cylinder) relative to the trigger pin. Rotate in the direction of. The trigger pin is at the intersection 3545 of the cylindrical cam slot 3544 when in the position BC2 ″. In addition, when the trigger pin is in position BC2 ″, (i) the cylindrical cam cylinder and the cutting tip have been rotated about 127 degrees in the clockwise direction since starting the first actuation of the trigger. , (Ii) the guide pin is at position CT2 ″ and (iii) the cutting tip is in a partially extended position.

  [00326] With continued reference to FIG. 36A, the trigger pin contacts the first curved wall 3567 of the follower guide opening 3565 when in the position BC2 ''. Since the first curved wall 3567 of the follower guide opening 3565 is aligned along one path of the intersection point 3545 of the cylindrical cam slot 3544, the follower guide replaces when the trigger pin passes through the position BC2 ''. The path is prevented and the trigger pin is guided straight through the intersection 3545 of the cylindrical cam slot 3544. In some embodiments, the apex between the first curved wall 3567 and the second curved wall 3569 does not engage the trigger pin longitudinally from the wall of the cylindrical cam slot 3544 (eg, Offset by approximately 0.025 inches). This facilitates guiding the trigger pin straight through the intersection 3545 of the cylindrical cam slot 3544. In some embodiments, when the trigger pin passes the intersection 3545, the trigger pin can be smoothly moved and the misalignment between the cylindrical cam and the follower guide can be relatively small. The first curved wall 3567 extends beyond the wall of the cylindrical cam slot 3544 (eg, the vertical distance between the cylindrical cam slot 3544 and the furthest point on the first curved wall 3567 is about zero). .010 inches).

  [00327] When the user continues to pull the trigger and the trigger pin continues to move proximally, the cylindrical cam cylinder, the cutting tip, and the follower guide rotate in a clockwise direction from position BC2 ″ to position BC3 ″. Continue to rotate. When the trigger pin is in position BC3 ″, (i) the cylindrical cam cylinder and the cutting tip have been rotated about 140 degrees in the clockwise direction since starting the first actuation of the trigger, (ii ) The guide pin is at position CT3 ″, and (iii) the cutting tip is in a fully extended position.

  [00328] As the user continues to pull the trigger and the trigger pin continues to move proximally, the cylindrical cam cylinder, cutting tip, and follower guide continue to rotate in a clockwise direction. Specifically, the trigger pin moves from position BC3 ″ to position BC4 ″. When the trigger pin is in position BC4 ″, (i) the cylindrical cam cylinder and the cutting tip have been rotated about 177 degrees in the clockwise direction since starting the first actuation of the trigger, (ii ) The guide pin is at position CT4 ″ and (iii) the cutting tip is in a partially extended position.

  [00329] When the trigger pin is at the position BC4 ", it contacts the wall 3571 of the opening 3565 of the follower guide. When the trigger pin moves from the first fixed position (BC1 ″) to the position BC4 ″, the follower guide and the cylindrical cam cylinder rotate together due to the presence of one of the aforementioned relative rotation prevention mechanisms. . For example, the cylindrical cam cylinder and follower guide include a relative rotation blocking mechanism 2475 (see FIGS. 24-28). In this case, the first spring pin 2410 on the follower guide is engaged with the curved concave portion 2404 of the projection 2402 of the cylindrical cam cylinder, so that the follower guide and the cylindrical cam cylinder move rotationally with respect to each other. To prevent. Referring to FIG. 36B, the trigger pin engages the follower guide wall 3571 when moving beyond the position BC4 ″ toward the position BC5 ″, thereby causing the follower guide to move relative to the cylindrical cam cylinder. It is rotated counterclockwise and pushed from the first relative rotation prevention position (GS1 ″) to a movable position. That is, when the trigger pin moves from the position BC4 ″ to the position BC5 ″, the follower guide is in a position where it can move with respect to the cylindrical cam cylinder. Once the trigger pin reaches the position BC5 ″, the follower guide and the cylindrical cam cylinder are in the second relative rotation prevention position (GS2 ″). In the second relative rotation prevention position (GS2 ″), for example, the second spring pin 2412 on the follower guide is used to prevent the follower guide from rotating further in the counterclockwise direction with respect to the cylindrical cam cylinder. Engages with the curved recess 2404 of the projection 2402 of the cylindrical cam cylinder, and the first engagement surface 2413 on the follower guide engages with the projection 2402.

  [00330] Referring still to FIG. 36B, when the user continues to pull the trigger and moves the trigger pin from position BC4 ″ to position BC5 ″, the cylindrical cam cylinder and cutting tip are in a clockwise direction relative to the trigger pin. Continue to rotate. However, the follower guide does not continue to rotate relative to the trigger pin, thereby rotating relative to the cylindrical cam cylinder. Specifically, the follower guide rotates about 110 degrees counterclockwise with respect to the cylindrical cam cylinder to the second relative rotation prevention position (GS2 ″). When the trigger pin is in position BC5 ″, (i) the trigger has finished moving proximally, and (ii) the cylindrical cam cylinder has been in the clockwise direction since it has initiated the first actuation of the trigger. (Iii) the guide pin is at position CT5 ″ and (iv) the cutting tip is in the most retracted position. In addition, the cutting tip has been rotated about 284 degrees in total in the clockwise direction from the start of the first actuation of the trigger. Since the guide pin engages the wall of the slot 3516 of the cutting tip before the trigger pin reaches the position BC5 ″ (ie, the guide pin reaches the position CT5 ″), the rotation of the cutting tip is a cylindrical cam. Less than the rotation of the cylinder. After the guide pin engages the wall of the slot 3516 at the cutting tip, the cylindrical cam cylinder rotates about 3 degrees in the clockwise direction. As a result, when the trigger pin approaches the position BC5 ″, the cylindrical cam cylinder rotates about 3 degrees with respect to the cutting tip. The relative rotation between the cylindrical cam cylinder and the cutting tip is manifested by the rotational deflection of the flexible inner sheath.

  [00331] The user can release the trigger after the trigger pin reaches position BC5 ''. When the user releases the trigger, a constant load spring attached to the trigger causes the trigger and trigger pin to reverse direction and advance toward their distal position. When the trigger and trigger pin begin to move toward the distal position, the rotation of the cylindrical cam cylinder and cutting tip relative to the trigger pin is stationary. Therefore, when the user releases the trigger, the trigger pin moves from position BC5 "toward position BC6". When the trigger is in position BC6 ″, (i) the cylindrical cam cylinder has been rotated about 287 degrees in the clockwise direction since starting the first actuation of the trigger, and (ii) the guide pin is Still in position CT5 ″, (iii) the cutting tip is still in the most retracted position. However, the trigger pin is not yet at the most distal position at position BC6 ''. In order to reach the most distal position BC7 '' of the trigger pin, the cylindrical cam cylinder rotates about 33 degrees in the counterclockwise direction. In some embodiments, when the trigger pin moves from position BC6 ″ to position BC7 ″, the wall of the cylindrical cam slot 3544 and / or the wall of the follower guide opening 3565 is rounded (eg, Engage with corner (radius 0.050 inch). Such a structure makes it easy to reliably slide the trigger pin to the position BC7 ″. The trigger pin is in a second home position within the cylindrical cam cylinder when in the position BC7 ''. When the trigger pin is in position BC7 ″, (i) the cylindrical cam cylinder and cutting tip have been rotated about 254 degrees in total in the clockwise direction since starting the first actuation of the trigger; (Ii) The guide pin is at position CT7 ″, and (iii) the cutting tip is retracted into the outer sheath.

  [00332] Still referring to FIG. 36B, when the trigger pin is in its second home position (BC7 "), the follower guide is in its second relative rotation blocking position (GS2"). When starting the second actuation of the trigger to move the trigger pin proximally, the follower guide and the cylindrical cam cylinder remain stationary relative to each other, and the cylindrical cam cylinder, the cutting tip, and the follower guide are Rotates counterclockwise. When the trigger pin is in position BC8 ″, (i) the cylindrical cam cylinder and the cutting tip have been rotated about 114 degrees counterclockwise since starting the second actuation of the trigger, ( ii) The guide pin is at position CT8 ″, and (iii) the cutting tip is at the most extended position.

  [00333] When the user continues the second actuation of the trigger and the trigger pin continues to move proximally, the cylindrical cam cylinder, cutting tip, and follower guide rotate counterclockwise with respect to the trigger pin Keep doing. When the trigger pin is in position BC9 ″, (i) the cylindrical cam cylinder and the cutting tip have been rotated about 127 degrees counterclockwise since starting the second trigger operation, ii) the guide pin is at position CT9 ″, (iii) the cutting tip is in a partially extended position, and (iv) the trigger pin is at the intersection 3545 of the cylindrical cam slot 3544. The trigger pin contacts the second curved wall 3569 of the follower guide opening 3565 when in the position BC 9 ″. Since the second curved wall 3569 of the follower guide opening 3565 is aligned along one path of the intersection point 3545 of the cylindrical cam slot 3544, the follower guide replaces when the trigger pin passes through the position BC9 ''. The path is prevented and the trigger pin is guided straight through the intersection 3545 of the cylindrical cam slot 3544.

  [00334] When the user continues to actuate the trigger and the trigger pin continues to move proximally, the cylindrical cam cylinder, the cutting tip, and the follower guide continue to rotate in the counterclockwise direction. When the trigger pin is at position BC10 ″, (i) the cylindrical cam cylinder and cutting tip have rotated about 177 degrees in the clockwise direction since starting the second actuation of the trigger, (ii ) The guide pin is at position CT10 ″, (iii) the cutting tip is in a partially extended position, and (iv) the trigger pin contacts the wall 3573 of the follower guide opening 3565.

  [00335] When the trigger pin moves from its second home position (BC7 ") to position BC10", the follower guide and the cylindrical cam cylinder rotate together due to the presence of the relative rotation prevention mechanism. For example, the second spring pin 2412 on the follower guide is engaged with the curved recess 2404 of the projection 2402 of the cylindrical cam cylinder, which causes the follower guide and the cylindrical cam cylinder to rotate relative to each other. To prevent. Referring to FIG. 36C, the trigger pin engages the follower guide wall 3573 as it moves beyond position BC10 ″ toward position BC11 ″, thereby causing the follower guide to move relative to the cylindrical cam cylinder. Rotate clockwise and push from the second relative rotation prevention position (GS2 ″) to a movable position. That is, when the trigger pin moves from the position BC10 ″ to the position BC11 ″, the follower guide is in a position where it can move with respect to the cylindrical cam cylinder. Once the trigger pin reaches the position BC11 ″, the follower guide and the cylindrical cam cylinder are returned to the first relative rotation prevention position (GS1 ″). In the first relative rotation prevention position (GS1 ″), in order to prevent the follower guide from rotating further in the clockwise direction with respect to the cylindrical cam cylinder, for example, a first spring pin 2410 on the follower guide is provided. A cylindrical cam cylinder projection 2402 engages with a curved recess 2404, and a second engagement surface 2414 (see FIG. 25) on the follower guide engages with the projection 2402.

  [00336] With continued reference to FIG. 36C, when the user continues the second actuation of the trigger and the trigger pin continues to move proximally, the cylindrical cam cylinder and cutting tip continue to rotate in a counterclockwise direction. . However, the follower guide does not continue to rotate with respect to the trigger pin, and the trigger pin rotates only with respect to the cylindrical cam cylinder. Specifically, the follower guide rotates about 110 degrees in the clockwise direction with respect to the cylindrical cam cylinder up to the first relative rotation prevention position (GS1 ″). When the trigger pin is in position BC11 ″, (i) the trigger has finished moving proximally, and (ii) the cylindrical cam cylinder and cutting tip have started the second actuation of the trigger; It has been rotated about 287 degrees counterclockwise, (iii) the guide pin is at position CT11 ″, and (iv) the cutting tip is in the most retracted position.

  [00337] The user can release the trigger after the trigger pin reaches position BC11 ''. When the user releases the trigger, a constant load spring attached to the trigger causes the trigger and trigger pin to reverse direction and advance toward their distal position. When the trigger and trigger pin begin to move toward the distal position, the rotation of the cylindrical cam cylinder and cutting tip relative to the trigger pin is stationary. Therefore, when the user releases the trigger, the trigger pin moves from position BC11 "toward position BC12". When the trigger is in position BC12 ″, (i) the cylindrical cam cylinder and cutting tip are still in a position that has been rotated about 287 degrees counterclockwise since starting the second actuation of the trigger. , (Ii) the guide pin is still in position CT11 ″ and (iii) the cutting tip is still in the most retracted position. As the trigger and trigger pin continue to move toward their distal position, the cylindrical cam cylinder and cutting tip rotate about 33 degrees in a clockwise direction relative to the trigger pin, and the trigger pin is in its first home position ( Return to BC1 ″). In some embodiments, when the trigger pin moves from position BC12 ″ to position BC1 ″, the wall of the cylindrical cam slot 3544 and / or the wall of the follower guide opening 3565 is rounded (eg, Engage with corner (radius 0.050 inch). Such a structure makes it easy to securely slide the trigger pin to the position BC1 ″. When the trigger pin returns to its first home position (BC1 ″), the guide pin returns to its initial position (CT1 ″) and the cutting tip remains in the retracted position inside the outer sheath. The user then repeats this process as necessary.

  [00338] FIG. 37 depicts a two-dimensional view of the profile of the cylindrical cam slot 3744 formed in any of the cylindrical cam cylinders described herein. The cam slot 3744 defines a path for the follower (eg, trigger pin 1528), generally like an “hourglass”, or like a “figure 8”. When an initial or first actuation is applied to the trigger, the trigger pin traverses approximately half of the cam slot 3744, and when a subsequent or second actuation is applied to the trigger, the trigger pin is cam Cross the remainder of the slot 3744 (ie about half of the cam slot 3744). In each case, as described in more detail below, a follower guide, eg, follower guide 1521, causes the trigger pin to pass straight through the intersection (or intersection) 3745 of the cam slot 3744 during each actuation of the trigger. move on. In other words, the follower guide causes the trigger pin to advance from the first leg 3747 of the cam slot 3744 to the second leg 3749 of the cam slot 3744 and then from the third leg 3751 of the cam slot 3744 to the first of the cam slot 3744. Go to 4th leg 3753.

  [00339] Each of the legs 3747, 3749, 3751, and 3753 advances through the intersection 3745, and is possibly coupled to the cylindrical cam assembly, and the trigger pin is connected to the walls of the legs 3747, 3749, 3751, and 3753. Shaped to prevent engagement. In some embodiments, each of legs 3747, 3749, 3751, and 3753 gradually increases in width toward intersection point 3745. Specifically, a first angular wall 3760 included in the first leg 3747 is disposed on the distal side of the first leg 3747 adjacent to the intersection 3745. First angled wall 3760 is angled away from first trigger pin path 3762 (ie, the path traversed by the trigger pin during the first actuation of the trigger) toward intersection 3745. The first angular wall 3760 has a length in the range of about 0.25 to 0.40 inches, more specifically about 0.33 inches, and in the range of about 1 to 7 degrees. An angle, more specifically about an angle of about 4 degrees, leaves the first trigger pin path 3762. Similarly, a second angular wall 3764 included in the second leg 3749 is disposed on the distal side of the second leg 3749 adjacent to the intersection 3745. Second angular wall 3764 is angled away from first trigger pin path 3762 toward intersection 3745. Second angular wall 3764 has a length in the range of about 0.18 to 0.32 inches, more specifically about 0.25 inches, in the range of about 4 to 10 degrees. An angle, more specifically about 7 degrees, leaves the first trigger pin path 3762. A third angular wall 3766 included in the third leg 3751 is disposed on the distal side of the third leg 3751 adjacent to the intersection 3745. The third angular wall 3766 is angled away from the second trigger pin path 3768 (ie, the path traversed by the trigger pin during the second actuation of the trigger) toward the intersection 3745. The third angular wall 3766 has a length in the range of about 0.25 to 0.40 inches, more specifically about 0.33 inches, and in the range of about 1 to 7 degrees. Leave the second trigger pin path 3768 at an angle, more specifically at an angle of about 4 degrees. A fourth angular wall 3770 included in the fourth leg 3753 is disposed on the distal side of the fourth leg 3753 adjacent to the intersection 3745. Fourth angular wall 3770 is angled away from second trigger pin path 3768 toward intersection 3745. The fourth angular wall 3770 has a length in the range of about 0.18 to 0.32 inches, more specifically about 0.25 inches, and in the range of about 4 to 10 degrees. An angle, more specifically about an angle of about 7 degrees, leaves the second trigger pin path 3768.

  [00340] The above discussion describes a cylindrical cam cylinder and follower guide in the context of a medical device. However, cylindrical cam cylinders and follower guides according to the present disclosure are used with other types of devices (eg, non-medical devices) that convert translational input into rotational output. That is, in a cylindrical cam cylinder and follower guide according to the present disclosure, a first translation input (eg, a first actuation of a translatable trigger) provides a first rotational output (eg, rotation of a shaft in a first direction). , A second translational input (eg, a second actuation of a translatable trigger) is used to provide a second rotational output (eg, rotation of the shaft in a second direction).

  [00341] The above discussion discusses an inner sheath that includes a cutting tip that travels at a specific speed (eg, constant speed and / or variable speed). However, this speed also depends on the rotational speed of the inner sheath and the traveling speed in the longitudinal direction (i.e. the extension direction and / or the retraction direction), and as a result, the longitudinal movement of the trigger and the rotational movement of the cylindrical cam cylinder. It also depends on the speed of operation of the included trigger assembly. Therefore, discussion and / or comparison of the speed at which the blades travel assumes that the means for actuating causes the inner sheath to stretch at a relatively constant speed. Regardless of whether this assumption is accurate, the greater the amount of extension of the blade per given amount of rotation, the greater the rate and speed at which the blade will extend, thereby allowing more tissue per revolution. A surgical device having the ability to cut is provided.

  [00342] Referring to FIG. 38, a front view of an alternative embodiment of the distal portion of the assembled sheath assembly 3812 of the present disclosure is depicted. The sheath assembly 3812 includes an inner sheath assembly and an outer sheath assembly. Referring to FIG. 38A, a cross-sectional view of the distal end of the sheath assembly 3812 is shown, FIG. 39 is an exploded view of the distal end of the sheath assembly 3812, and the sheath assembly 3812 includes an outer band 3836, Guide pin 3840, cutting tip 3832, flexible inner sheath 3820, flexible outer sheath 3824, outer jacket 3828, inner key (not shown), outer key (not shown), and rigid inner tube (shown) Including some or all of the components (not shown). Although the inner key, outer key, and rigid inner tube are not shown in FIG. 38, these items are represented in FIGS. 6-8 and 16-18.

  [00343] The sheath assembly 3812 illustrated in FIGS. 38 and 39 is similar to the sheath assembly 112 illustrated in FIGS. 6-8 and the sheath assembly 1212 illustrated in FIGS. However, the embodiment of the sheath assembly 3812 depicted in FIGS. 38-39 provides a smaller profile. That is, the total diameter of the sheath assembly 3812 shown in FIGS. 38 and 39 is the outer diameter of the sheath assembly 112 shown in FIGS. 6 to 8 and the sheath assembly 1212 shown in FIGS. Smaller than. As shown in FIGS. 6 and 8, the flexible inner sheath 620 is applied in an overlapping manner with respect to the cutting tip 632. Specifically, the proximal end of cutting tip 632 is inserted into the distal end of flexible inner sheath 620 such that flexible inner sheath 620 overlaps the proximal end of cutting tip 632. . The sheath assembly 1212 depicted in FIGS. 16-18 has an overlapping design similar to the sheath assembly 112 depicted in FIGS. This overlapping design increases the overall thickness and diameter of the sheath assembly, thereby increasing the difficulty of the surgical device's ability to travel through the small diameter vasculature, especially the sheath assembly. there's a possibility that.

  [00344] The sheath assembly 3812 depicted in FIG. 39 has a smaller profile compared to the sheath assembly 112 depicted in FIGS. 6-8 and the sheath assembly 1212 depicted in FIGS. Which improves the ease and ability of the surgical device to move through the small diameter vasculature, particularly the ability of the sheath assembly. As shown in FIGS. 38 and 39, the sheath assembly 3812 has a non-overlapping design. That is, the flexible outer sheath 3824 contacts the outer band 3836 in a non-overlapping manner and the inner sheath 3820 contacts the flexible inner sheath 3820 in a non-overlapping manner. In other words, the outer band 3836 is not inserted into the flexible outer sheath 3824. Rather, the proximal end of the outer band 3836 is welded against the distal end of the flexible outer sheath 3824 so that the lumen diameter of the outer band 3836 and the diameter of the flexible outer sheath 3824 are exactly the same. Is done. Similarly, the cutting tip 3832 is not inserted into the flexible inner sheath 3820. Rather, the proximal end of the cutting tip 3832 touches the distal end of the flexible inner sheath 3820 so that the diameter of the cutting tip 3832 lumen is exactly the same as the diameter of the flexible inner sheath 3820 lumen. And welded.

  [00345] As a result of the non-overlapping design, the sheath assembly 3812, in particular the outer jacket 3828, the outer sheath 3824, and the inner sheath 3820 have the following dimensions.

  [00346] Referring to FIGS. 40 and 40A, an enlarged view of the distal end of the outer sheath assembly 3802 is shown. As discussed in more detail below, the outer sheath assembly includes a hypotube 3824. As will also be discussed in more detail below, the hypotube 3824 includes a plurality of flexible segments resulting from the kerf design. However, it is desirable that the most distal end of the hypotube 3824 includes an uncut segment 3842 that abuts the proximal end of the outer band 3836. This uncut segment 3842 of the hypotube 3824 is welded to the outer band 3836 in a non-overlapping manner such that the lumen diameter of the outer band 3836 and the lumen diameter of the flexible outer sheath 3824 are completely aligned. Is done. With reference to FIGS. 41 and 41A, the inner sheath assembly includes a hypotube 3820. Desirably, the most distal end of the hypotube 3820 includes an uncut segment 3862 that abuts the proximal end of the cutting tip 3832. This uncut segment 3862 of the hypotube 3820 has a cutting tip 3832 in a non-overlapping manner such that the lumen diameter of the cutting tip 3832 and the lumen diameter of the flexible inner sheath 3804 are completely aligned. Welded to.

  [00347] Referring to FIGS. 42, 42A and 42B, an outer sheath 3824 constructed from a hypotube having a plurality of segments 3842, 3844, 3846, 3848 is illustrated. Segment 3842 is the most distal segment and segment 3848 is the most proximal segment. Segments 3842 and 3848 are uncut segments and segments 3844 and 3846 are cut segments. That is, segments 3842 and 3848 do not include kerfs, and segments 3844 and 3846 include kerfs. Segments 3844, 3846 include kerfs, but segment 3844 has a constant flexibility from the distal end to the proximal end, and segment 3846 has a variable flexibility from the distal end to the proximal end. That is, the flexibility of segment 3846 changes to be lower at the proximal end and higher at the distal end. In other words, the flexibility of the segment 3846 changes to decrease from the distal end to the proximal end. In addition, the distal cut segment 3844 is more flexible than the proximal cut segment 3846. Although there are only four segments of the hypotube as described herein and represented in FIG. 42, fewer or more segments may be included within the hypotube. These segments include various cut and uncut configurations to give the hypotube a flexible property.

  [00348] With continued reference to FIGS. 42 and 42B, the uncut segment 3842 has a length of about 0.025 inches, and the constant-flexible (cut) segment 3844 has a length of about 3. The variable-length (cut) segment 3846, having a length of 0 inches, has a length of about 3.732 inches, and the uncut segment 3848 has a length of about 2.0 inches. Have The segment 3844 has a certain flexibility over its entire length because it has a certain pattern in which the kerfs 3849 and non-kerfs 3851 alternate. For example, the pattern of segments 3844 with alternating kerfs 3849 and non-kerfs 3851 is about 0.001 inches wide 3850 and about 120 ° circumference over a length of 3.0 inches in the longitudinal direction. It includes a kerf 3849 having a line length 3852 followed by a non-kerf portion 3851 having a circumferential length 3854 of about 31.5 ° over a 3.0 inch longitudinal length. Also, the kerfs 3849 (or portions thereof) are disposed adjacent to each other along the axial length of the segment 3844, consistently spaced at a constant pitch (P) of about 0.025 inches. Is desirable. Also, as shown in FIG. 44, the kerf 3849 is about 2.0 ° to about 3.0 °, specifically about 2.0 ° from an axis perpendicular to the longitudinal axis of the outer sheath 3824. 2.1 °, 2.2 °, 2.3 °, 2.4 °, 2.5 °, 2.6 °, 2.7 °, 2.8 °, 2.9 ° or 3.0 ° Are offset by a pitch angle (Θ) of. The pitch angle may be the same throughout the length of segment 3844, may increase from the distal end of segment 3844 to the proximal end, or may decrease from the distal end of segment 3844 to the proximal end.

  [00349] With continued reference to FIG. 42, the variable-flexible (cut) segment 3846 is flexible as the pitch of the kerf 3849 increases from the distal end to the proximal end. Drop from the distal end to the proximal end. That is, segment 3846 spans its longitudinal length of 3.732 inches, for example, a portion of a kerf 3849 with a circumference of about 120 ° followed by a portion of a kerf 3851 with a circumference of about 31.5 ° The kerfs 3849 and non-kerfs 3851 have an alternating pattern, but the distance between adjacent kerfs 3849 (or portions thereof) is about 0.025 inches at the distal end. Increasing along the axial length of segment 3844 from a pitch of .about.0.080 inches to the proximal end.

  [00350] In addition, the kerf 3849 includes about 2.0 ° to about 10.0 ° from the axis perpendicular to the longitudinal axis of the outer sheath 3824, specifically including any increments of 0.1 °. About 2.0 °, 3.0 °, 4.0 °, 5.0 °, 6.0 °, 7.0 °, 8.0 °, 9.0 ° or 10.0 ° pitch angle ( Offset by Θ). The pitch angle (Θ) may be constant along the segment 3846 or may vary. That is, the pitch angle may be the same over the entire length of segment 3846, may increase from the distal end of segment 3846 to the proximal end, or may decrease from the distal end of segment 3846 to the proximal end. For example, for the entire segment 3844, the pitch (eg, 0.025 inch pitch) and pitch angle (eg, 2.0 °, 2.2 °, 2.6 ° pitch angle (Θ)) are the same, and the segment The pitch and / or pitch angle of 3846 varies from the distal end (eg, having a pitch of 0.025 inches and a pitch angle (Θ) of 2.0 °, 2.2 °, 2.6 °) to the proximal end ( (E.g., having a pitch of 0.0080 inches and a pitch angle (Θ) of 6.3 °, 7.1 °, 8.2 °), while segments 3844 and 3846 are both kerfs. 3849 portions (for example, a cut 120 ° circumference) and uncut grooves 3851 portions (eg, a not cut 31.5 ° circumference) maintain the same pattern. A change in the pattern of segment 3846 results in a relatively small transition in flexibility from distal, flexible cut segment 3844 to proximal, non-cut segment 3848. A sheath 3824 is provided.

  [00351] Referring to FIGS. 43, 43A, and 43B, an inner sheath 3820 constructed from a hypotube having a plurality of segments 3862, 3864, 3866, 3868 is illustrated. Segment 3862 is the most distal segment and segment 3868 is the most proximal segment. Segments 3862 and 3868 are uncut segments, and segments 3864 and 3866 are cut segments. That is, segments 3862, 3868 do not include kerfs, and segments 3864, 3866 include kerfs. Segments 3864, 3866 include kerfs, but segment 3864 has a constant flexibility from the distal end to the proximal end, and segment 3866 has a variable flexibility from the distal end to the proximal end. That is, the flexibility of segment 3866 changes to be lower at the proximal end and higher at the distal end. In other words, the flexibility of the segment 3866 changes to decrease from the distal end to the proximal end. In addition, the distal cut segment 3864 is more flexible than the proximal cut segment 3866. Although there are only four segments of the hypotube as described herein and represented in FIG. 43, fewer or more segments may be included within the hypotube. These segments include various cut and uncut configurations to give the hypotube a flexible property.

  [00352] With continued reference to FIGS. 43 and 43B, the uncut segment 3862 has a length of about 0.025 inches, and the constant-flexible (cut) segment 3864 has a length of about 3. Segment 3866 having a length of 0 inches to about 3.50 inches, variable flexibility (cut), has a length of about 3.725 inches, and uncut segment 3868 is about It has a length of 7.0 inches. The segment 3864 has a certain flexibility over its entire length because it has a certain pattern in which the kerfs 3869 and non-kerfs 3871 alternate. For example, the pattern of segments 3864 with alternating kerfs 3869 and non-grooved 3871 portions is about 0.001 inches wide 3870 and about 120 ° circumference over a length of 3.0 inches in the longitudinal direction. A portion of a kerf 3869 having a line length 3872 followed by a portion of a non-kerf 3871 having a circumferential length 3874 of about 31.5 ° over a 3.0 inch longitudinal length. Including. The spacing between adjacent kerfs 3869 (or portions thereof) ranges from about 0.025 inch pitch at the distal end of segment 3864 along the axial length of segment 3864 to about 0.00 at the proximal end of segment 3864. It is also desirable to have a variable pitch (P) to a pitch of 080 inches. Further, the kerf 3869 is about 2.0 ° to about 4.0 ° from the axis perpendicular to the longitudinal axis of the inner sheath 3820, specifically about 2.0 °, 2.1 °, 2.2. °, 2.3 °, 2.4 °, 2.5 °, 2.6 °, 2.7 °, 2.8 °, 2.9 °, 3.0 °, 3.1 °, 3.2 Offset with a pitch angle (Θ) of °, 3.3 °, 3.4 °, 3.5 °, 3.6 °, 3.7 °, 3.8 °, 3.9 ° or 4.0 ° ing. The pitch angle may be the same over the entire length of segment 3864, may increase from the distal end of segment 3864 to the proximal end, or may decrease from the distal end of segment 3864 to the proximal end.

  [00353] With continued reference to FIG. 43, the variable-flexible (cut) segment 3866 increases flexibility as the kerf pitch increases from the distal end to the proximal end. Decreasing from the distal end to the proximal end. That is, segment 3866 is cut over its 3.846 inch longitudinal length, for example, about 120 ° circumferential kerf portion followed by about 31.5 ° circumferential kerf portion. The groove portions and non-grooved portions have an alternating pattern, but the distance between adjacent kerfs 3870 (or portions thereof) is closer to the distal end pitch of about 0.025 inches. Increasing along the axial length of segment 3864 to a pitch of 0.080 inches at the distal end.

  [00354] The kerf also includes about 5.0 ° to about 15.0 ° from an axis perpendicular to the longitudinal axis of the inner sheath 3820, specifically including any increment of 0.1 °, Offset by a pitch angle (Θ) of about 5.0 °, 6.0 °, 7.0 °, 8.0 °, 9.0 °, 10.0 ° or 15.0 °. The pitch angle (Θ) may be constant along the segment 3866 or may vary. That is, the pitch angle may be the same over the entire length of segment 3866, may increase from the distal end of segment 3866 to the proximal end, or may decrease from the distal end of segment 3866 to the proximal end. For example, for the entire segment 3864, the pitch (eg, 0.025 inch pitch) and pitch angle (eg, 2.4 °, 2.8 °, 3.3 ° pitch angle (Θ)) are the same, and the segment The pitch and / or pitch angle of 3846 varies from the distal end (eg, having a pitch of 0.025 inches and a pitch angle (Θ) of 2.4 °, 2.8 °, 3.3 °) to the proximal end ( (E.g., having a pitch of 0.0080 inches and a pitch angle (Θ) of 7.6 °, 8.8 °, 10.4 °), while segments 3864 and 3866 are both cut off. The same pattern of alternating groove portions (eg, a cut 120 ° circumference) and non-cut grooves (eg, an uncut 31.5 ° circumference) is maintained. The change in the pattern of segment 3866 causes the inner transition to move from a relatively flexible cut segment 3864 to a proximal, rigid, uncut segment 3868. A sheath 3820 is provided.

  [00355] The inner sheath (inner hypotube) 3820 is more flexible when compared to the outer sheath (outer hypotube) 3824. Specifically, the flexible segment 3864 of the inner sheath 3820 is more flexible than the flexible segment 3844 of the outer sheath 3824, and the flexible segment 3866 of the inner sheath 3820 is more flexible than the outer sheath 3824. More flexible than the flexible segment 3846.

  [00356] Referring to FIG. 45A, a block diagram illustrating the axial alignment of the outer sheath (outer hypotube) 3824 with respect to the corresponding segment of the inner sheath (inner hypotube) 3820 is shown. The entire uncut distal segment 3842 (including its distal and proximal ends) of the outer hypotube 3824 is substantially the same as the uncut distal segment 3862 (its distal end) of the inner hypotube 3820. And the proximal end) in an axial alignment. The distal ends of the segments of the flexible segments 3844, 3864 having a certain flexibility are substantially axially aligned along the longitudinal axis of the outer hypotube 3824 and the inner hypotube 3820, but the inner The length of the flexible segment 3864 of the hypotube 3820 is longer than the length of the flexible segment 3844 of the outer hypotube 3824 so that the proximal end of the flexible segment 3844 and the flexible segment 3864 are near. The proximal end of the flexible segment 3864 of the inner hypotube 3820 (having some flexibility) and the flexible segment 3844 of the outer hypotube 3824 Both with a proximal end (with constant flexibility) and a distal end with flexible segment 3846 (with variable flexibility) Bring overlap. Therefore, the distal end of the flexible segment 3846 and the distal end of the flexible segment 3866 are not axially aligned, thereby causing the flexible segment 3846 of the outer hypotube 3824 (variable flexibility The distal end of the flexible segment 3864 (having constant flexibility) and the distal end of the flexible segment 3866 (having variable flexibility) Results in an overlap between both. Also, the proximal end of flexible segment 3846 and the proximal end of flexible segment 3866 are not axially aligned. The proximal end of the flexible segment 3866 (having variable flexibility) of the inner hypotube 3820 is proximal to the proximal end of the flexible segment 3846 (having variable flexibility) of the outer hypotube 3824. Overlaps both the uncut segment 3848 and the distal end. Also, the uncut segments 3848, 3868 of the outer hypotube 3824 (eg, distal, central and proximal) overlap the inner hypotube 3820. This mechanism of overlapping between the inner hypotube segment and the outer hypotube segment provides different flexibility between the inner hypotube and the outer hypotube, thus allowing for possible torsion of the hypotube Prevent sex.

  [00357] FIG. 45A represents a block diagram of an outer sheath (outer hypotube) 3824 with respect to an inner sheath (inner hypotube) 3820 having a particular axial alignment of the corresponding segments, but the outer sheath (outer hypotube). The segment of the tube) 3824 and the segment of the inner sheath (inner hypotube) 3820 may have alternative forms of features. For example, referring to FIG. 45B, the entire uncut distal segment 3842 ′ (including its distal and proximal ends) of the outer hypotube 3824 ′ is substantially cut off of the inner hypotube 3820 ′. An axial alignment of the entire distal segment 3862 ′ (including its distal and proximal ends). The distal ends of the segments of flexible segments 3844 ', 3864' having a certain flexibility are aligned substantially axially along the longitudinal axis of the outer hypotube 3824 'and the inner hypotube 3820'. The length of the flexible segment 3864 'of the inner hypotube 3820' is shorter than the length of the flexible segment 3844 'of the outer hypotube 3824', thereby the proximal end of the flexible segment 3844 ' And the proximal end of the flexible segment 3864 ′ to prevent axial alignment, and the proximal end of the flexible segment 3844 ′ (having a certain flexibility) of the outer hypotube 3824 ′; Proximal end of flexible segment 3864 '(with constant flexibility) of inner hypotube 3820' and flexible segment 3866 '(variable flexibility) Resulting in overlap between both the distal end of a). Therefore, the distal end of the flexible segment 3846 ′ and the distal end of the flexible segment 3866 ′ are not axially aligned, thereby causing the flexible segment 3866 ′ of the inner hypotube 3820 ′. The distal end (with variable flexibility), the proximal end of the flexible segment 3844 '(with constant flexibility) of the outer hypotube 3824' and the flexible segment 3846 '(variable flexibility) Resulting in an overlap between both of the distal ends. Also, the proximal end of flexible segment 3846 'and the proximal end of flexible segment 3866' are not axially aligned. The proximal end of the flexible segment 3866 '(with variable flexibility) of the inner hypotube 3820' is the proximal end of the flexible segment 3846 '(with variable flexibility) of the inner hypotube 3820'. And the distal end of the proximal uncut segment 3848 '. Also, the uncut segments 3848 ', 3868' of the outer hypotube 3824 '(eg, distal, central and proximal) overlap the inner hypotube 3820'.

  [00358] Referring to FIG. 45C, the entire uncut distal segment 3842 '' (including its distal and proximal ends) of the outer hypotube 3824 '' is substantially the same as the inner hypotube 3820 '. It is axially aligned with the whole of the uncut distal segment 3862 ″ (including its distal and proximal ends). The distal ends of the segments of the flexible segments 3844 ″, 3864 ″ having a certain flexibility are substantially axial along the longitudinal axis of the outer hypotube 3824 ″ and the inner hypotube 3820 ″. The length of the flexible segment 3864 '' of the inner hypotube 3820 '' is shorter than the length of the flexible segment 3844 '' of the outer hypotube 3824 '' so that it is flexible. Prevent the proximal end of the flexible segment 3844 '' and the proximal end of the flexible segment 3864 '' from axially aligning, and the flexible segment 3844 '' (constant constant) of the outer hypotube 3824 ''. The proximal end of the inner hypotube 3820 ″ (with certain flexibility) and the flexible segment. Resulting in overlap between both cement 3866 '' distal end (with variable flexibility). Therefore, the distal end of the flexible segment 3846 '' and the distal end of the flexible segment 3866 '' are not axially aligned, thereby allowing the flexibility of the inner hypotube 3820 ''. The distal end of segment 3866 ″ (with variable flexibility) and the proximal end and flexible segment of flexible segment 3844 ″ (with constant flexibility) of outer hypotube 3824 ″ This provides an overlap between both of the distal ends of 3846 ″ (with variable flexibility). Also, the proximal end of the flexible segment 3846 "and the proximal end of the flexible segment 3866" are not axially aligned. The proximal end of the flexible segment 3846 '' (with variable flexibility) of the outer hypotube 3824 '' is the flexible segment 3866 '' (with variable flexibility) of the inner hypotube 3820 ''. And both the proximal end of the proximal uncut segment 3868 ″. Also, portions of uncut segments 3848 ", 3868" of outer hypotube 3824 "(eg, distal, central and proximal) overlap with inner hypotube 3820".

  [00359] Referring to FIG. 45D, the entire uncut distal segment 3842 "'(including its distal and proximal ends) of the outer hypotube 3824'" is substantially the same as the inner hypotube. Axisally aligned with the entire uncut distal segment 3862 '' '(including its distal and proximal ends) of 3820' ''. The distal ends of the segments of the flexible segments 3844 '' ', 3864' '' having a certain flexibility are substantially along the longitudinal axis of the outer hypotube 3824 '' 'and the inner hypotube 3820' ''. And the length of the flexible segment 3864 '' 'of the inner hypotube 3820' '' is greater than the length of the flexible segment 3844 '' 'of the outer hypotube 3824' ''. Longer, thereby preventing axial alignment of the proximal end of the flexible segment 3844 '' 'and the proximal end of the flexible segment 3864' '' and the inner hypotube 3820 '' '. The proximal end of the flexible segment 3864 '' '(with constant flexibility) and the flexible segment 3844' '' (with constant flexibility) of the outer hypotube 3824 '' '. Resulting in overlap between both the distal end of that) the proximal end of and flexible segments 3846 '' '(with variable flexibility). Therefore, the distal end of the flexible segment 3846 ′ ″ and the distal end of the flexible segment 3866 ′ ″ are not axially aligned, thereby preventing the outer hypotube 3824 ′ ″. The distal end of the flexible segment 3846 '' '(with variable flexibility) and the proximal of the flexible segment 3864' '' (with constant flexibility) of the inner hypotube 3820 '' ' An overlap is provided between both the end and the distal end of the flexible segment 3866 '' '(with variable flexibility). Also, the proximal end of the flexible segment 3846 "" and the proximal end of the flexible segment 3866 "" are not axially aligned. The proximal end of the flexible segment 3846 ′ ″ (with variable flexibility) of the outer hypotube 3824 ′ ″ is flexible segment 3866 ′ ″ (variable flexible) of the inner hypotube 3820 ′ ″. ) And the distal end of the proximal uncut segment 3868 '' '. Also, the uncut segments 3848 ′ ″, 3868 ′ ″ of the outer hypotube 3824 ′ ″ (eg, distal, central and proximal) and the inner hypotube 3820 ′ ″ Wrap.

  [00360] Although not shown in a particular figure, the scope of this disclosure is any combination of inner and outer hypotubes as represented in FIGS. 45A, 45B, 45C and 45D. And any combination of cut and uncut segments of such hypotubes.

  [00361] In the accompanying drawings, like parts and / or features have the same reference label. In addition, various parts of the same type are identified by following the reference label with letters that identify between similar parts. Where only the first reference label is used in the specification, the description is applicable to any similar part having the same first reference label, regardless of the second reference label. It is.

  [00362] Many variations and modifications of the disclosure may be utilized. Some features of the present disclosure may be provided without providing other features.

  [00363] In some embodiments, the systems and methods of this disclosure include a dedicated computer, programmed microprocessor or microcontroller and peripheral integrated circuit elements, ASICs or other integrated circuits, digital signal processors, discrete element circuits, etc. This is implemented together with a wiring-connected electronic circuit or logic circuit, a programmable logic device, a gate array such as PLD, PLA, FPGA, PAL, or any equivalent means. In general, any device or means capable of practicing the techniques presented herein will be used to implement various aspects of this disclosure. Exemplary hardware used in the disclosed embodiments, configurations and aspects include computers, portable devices, telephones (eg, cellular telephones, internet connectable telephones, digital telephones, analog telephones, hybrid telephones, etc.), and the like. Other hardware known in the art is included. Some of these devices include processors (eg, single or multiple microprocessors), storage devices, non-volatile storage devices, input devices, and output devices. Moreover, alternative software implementations include, but are not limited to, distributed processing or distributed processing of components / objects, parallel processing, or construct virtual machine processing to implement the methods described herein. Is done.

  [00364] The disclosure includes parts, methods, processes, systems, and / or devices in various aspects, embodiments, and / or configurations as substantially represented and described herein. Including various aspects, embodiments, configuration embodiments, subcombinations, and / or subsets thereof. Those skilled in the art will understand how to make and use the disclosed aspects, embodiments, and / or configurations after understanding the present disclosure. The present disclosure may be used to describe and / or describe in various aspects, embodiments, and / or configurations in various aspects, embodiments, and / or configurations, for example, to improve performance, achieve ease, and / or reduce cost of implementations. Providing devices and processes in the absence of any items, or in the various aspects, embodiments, and / or configurations, in the absence of items such as those used in previous devices or processes. .

  [00365] For example, although pin and slot cam configurations are discussed in this disclosure, other possible cam configurations may be used. For example, a captured ring cam configuration can be used. The ring included in the captured ring cam configuration is attached to at least one of an inner sheath (or inner member attached to the inner sheath) or an outer sheath (or outer member attached to the outer sheath); Captured by the two lobes that form the corners on the other sheath (or member). Even if the ring is captured by one lobe, the ring (on each side of the ring 1) so that the cutting surface is pushed in both the proximal direction (retracted direction) and the distal direction (extension direction). It is desirable to be captured by two lobes. A spring or other force that forces the inner sheath (or inner member) and cutting surface back into the outer sheath (or outer member) due to the benefit of being able to push the cutting surface in both directions with the aid of a captured cam configuration. A pull back mechanism is potentially unnecessary.

  [00366] Another example of an alternative embodiment includes replacing the cutting tip with a dilator top or separator tip. Further examples of alternative embodiments include changing the angle of rotation of the inner sheath assembly or cylindrical cam cylinder in a clockwise and / or counterclockwise direction. A further example of an alternative embodiment includes first rotating the cylindrical cam cylinder and inner sheath assembly in a counterclockwise direction followed by a clockwise direction.

  [00367] The foregoing discussion has been presented for purposes of explanation and explanation. The foregoing is not intended to limit the present disclosure to the form disclosed herein. For example, in the foregoing “Summary of the Invention”, various features of the present disclosure are grouped into one or more aspects, embodiments, and / or configurations in order to streamline the present disclosure. Features of aspects, embodiments, and / or configurations of the present disclosure may be combined with alternative aspects, embodiments, and / or configurations other than those discussed above. This method of disclosure is not to be interpreted as reflecting an intention that it requires more features than are expressly recited in each claim. Rather, the inventive aspects lie in less than all the features of the single disclosed aspect, embodiments and / or configurations described above, as reflected in the following claims. Accordingly, the following claims are hereby incorporated into this “Summary of the Invention”, with each claim standing on its own as a separate preferred embodiment of the disclosure.

  [00368] Moreover, the description includes descriptions of one or more aspects, embodiments, and / or configurations, specific variations, and modifications, but other variations, combinations, and modifications are For example, within the scope of the present disclosure, as is within the skill and knowledge of one of ordinary skill in the art after understanding the present disclosure. Such alternative, interchangeable and / or equivalent configurations, functions, including alternative, interchangeable and / or equivalent configurations, functions, ranges or steps to the claimed ones. Regardless of whether a scope or step is disclosed herein, it is intended to acquire rights to cover alternative aspects, embodiments, and / or configurations to the extent permitted, and any patent rights The subject that can be received is not intended to be made public.

Claims (20)

A device for removing an implant from a body vessel, said device comprising:
An outer sheath assembly, an inner sheath assembly, and a sheath assembly including a pin and a handle assembly including a trigger and a cylindrical cam cylinder;
The outer sheath assembly includes an outer sheath and an outer band, the outer band is coupled to the pin, and at least a portion of the outer sheath includes an outer hypotube;
The inner sheath assembly comprises an inner sheath and a tip, the tip has a cutting surface, and at least a portion of the outer sheath comprises an inner hypotube;
The inner sheath comprises a proximal end and a distal end, and the distal end of the inner sheath is coupled to the tip;
The tip comprises a cam slot for receiving the pin and cooperating with the pin;
The trigger comprises a trigger pin; the tubular cam cylinder comprises a tubular cam cylinder slot for receiving the trigger pin and cooperating with the trigger pin; and the proximal end of the inner sheath comprises:
(1) During the first operation of the trigger for moving the trigger pin proximally in the longitudinal direction, the cylindrical cam cylinder rotates in the first direction, whereby the tip portion moves in the longitudinal direction. While rotating the tip in the first direction,
(2) During the second operation of the trigger for moving the trigger pin proximally in the longitudinal direction, the cylindrical cam cylinder rotates in the second direction, whereby the tip portion moves in the longitudinal direction. While rotating the tip in the second direction,
Coupled to the cylindrical cam cylinder,
device.   The device of claim 1, wherein the outer sheath assembly is stationary and the inner sheath assembly is rotatable.   The device of claim 1, wherein the pin couples the tip of the inner sheath assembly to the outer band of the outer sheath assembly.   The device of claim 1, wherein the handle assembly further comprises a spring assembly coupled to the trigger.   The device of claim 4, wherein the spring is a constant load spring.   The device of claim 1, wherein the outer hypotube is laser cut and the inner hypotube is laser cut.   The device of claim 1, wherein the outer hypotube comprises a first outer segment and a second outer segment, and the inner hypotube comprises a first inner segment and a second inner segment.   The device of claim 7, wherein the first outer segment is distal to the second outer segment and the first inner segment is distal to the second inner segment.   The first outer segment has a first outer flexibility and a first outer length; the second outer segment has a second outer flexibility and a second outer length; The first inner segment has a first inner flexibility and a first inner length; the second inner segment has a second inner flexibility and a second inner length; 9. The device of claim 8, wherein the first outer flexibility is higher than the second outer flexibility, and the first inner flexibility is higher than the second inner flexibility.   The first outer flexibility is constant along the first outer length, the second outer flexibility is variable along the second outer length, and the first outer flexibility is variable along the second outer length. The device of claim 9, wherein inner flexibility is constant along the first inner length and the second inner flexibility is variable along the second inner length.   The device of claim 10, wherein the first outer length is shorter than the first inner length.   The device of claim 11, wherein the first outer flexibility is lower than the first inner flexibility.   The device of claim 9, wherein the second outer flexibility is lower than the second inner flexibility.   An inner distal end of the first inner length is axially aligned with an outer distal end of the first outer length, and the first inner length is an axis of the first outer length. 9. The device of claim 8, wherein the device is longer than the first outer length so as to overlap in a direction.   The second outer length has an outer distal end and an outer proximal end; the second inner length has an inner distal end and an inner proximal end; and 15. The device of claim 14, wherein the outer distal end axially overlaps the second outer distal end of the second outer length and a proximal end of a third outer length.   The device of claim 8, wherein the first inner segment has a constant pitch.   The device of claim 16, wherein the second inner segment has a variable pitch that increases from a distal end to a proximal end.   The device of claim 8, wherein the first outer segment has a constant pitch.   The device of claim 18, wherein the second outer segment has a variable pitch that increases from a distal end to a proximal end.   The device of claim 19, wherein the second outer segment has a variable angle that increases from a distal end to a proximal end.

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