Systems and methods for harvesting tendons
Patent Information
- Application Number
- CN202180036254.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2021-03-03
- Filing Date
- 2021-06-09
- Publication Date
- 2026-08-21
- Estimated Expiration
- 2041-06-09
AI Technical Summary
纤维肌腱组织可能使相关技术装置偏离其预期切割路径,导致不均匀且可能无用的移植物条带横截面
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Figure CN115666407B_ABST
Abstract
Description
[0001] Cross-reference to related applications
[0002] This application claims the benefit of U.S. Provisional Patent No. 63 / 036,562, filed June 9, 2020, entitled “System for Harvesting a Tendon”; and U.S. Provisional Patent No. 63 / 156,187, filed March 3, 2021, entitled “System and Method for Harvesting a Tendon”, which are incorporated herein by reference in their entirety.
[0003] This application relates to the international patent application filed on October 16, 2020, entitled “Tendon Harvesting Assemblies and Methods”, which is jointly owned and incorporated herein by reference in its entirety. Technical Field
[0004] This disclosure relates to a system and method for harvesting tendons, particularly for harvesting quadriceps tendons (QT). Background Technology
[0005] The quadriceps tendon is frequently used as a source of tissue grafts for ligament surgeries, such as anterior cruciate ligament (ACL) reconstruction. However, harvesting grafts from the QT presents several challenges because the QT is larger and stronger than other tendons, resulting in tough fibrous bundles of tissue that are difficult to dissect precisely and consistently. Furthermore, to minimize incisions around the target area, harvesting is preferably performed through a small incision near the knee. This may require a second person to retract the skin from the anterior QT surface while the surgeon is already working on the tendon tissue. Existing devices may require multiple cuts to dissect this tough tissue. Fiber tendon tissue can cause the associated techniques to deviate from their intended cutting path, resulting in uneven and potentially useless graft strip cross-sections. Further difficulties arise when terminating the graft at the proximal end of the strip and at the furthest point from the skin incision near the knee. This proximal incision may be performed somewhat blindly without creating a larger or second skin incision, thus being time-consuming and risking accidental tissue damage. Therefore, an improved system and associated method are needed that can consistently remove target-sized tendon tissue strips from the natural tendon, overcoming the problems disclosed herein. Summary of the Invention
[0006] This document describes a system comprising multiple devices for harvesting tissue grafts from surrounding tissue, such as QT. The entire QT is defined as the natural tissue, and the systems and methods described herein are configured to disconnect a portion or strip of this natural tissue from itself. Prior to harvesting or disconnection, the portion or strip is continuous and indistinguishable from the natural tissue. In other words, the portion or strip disconnected by the system disclosed herein is initially continuously attached to the natural tissue along the entire length of the resulting strip, including at least three lateral surfaces of the resulting strip. The system for forming the graft strip dissects along the entire length of the resulting strip or portion through a continuous length of the natural tissue. The shape of the resulting portion or strip is defined by the system disclosed herein and can be varied with different sizes and the methods of use and cutting tools of the disclosed system. In contrast, for example, a vascular harvesting tool disconnects a target vessel from the surrounding connective tissue along its length, which may include smaller vessels as well as other connective tissue and adipose tissue without preserving the natural vessel. Thus, the exemplary harvested vascular tissue strip (target vessel) is disconnected from multiple tissues different from the target natural vessel; the target natural vessel is not a removed portion of itself along the entire length of its harvested vessel. The target natural blood vessel can be identified from the surrounding connective tissue. It connects to multiple tissues along its length, and these tissues differ in composition from the target natural blood vessel. Furthermore, the blood vessel itself at least partially defines the shape and size of the harvesting tool or the tissue being harvested. As another example, a polyp removal device disconnects the polyp from the base tissue, which is not the same tissue; the polyp only connects to the base at its first end. Furthermore, the polyp is identifiable from the base tissue, and the device disconnecting the polyp does not define the boundaries of the removed polyp. The entire polyp is removed, and the polyp defines the boundaries.
[0007] This document discloses a system for forming graft strips from natural tendons. It includes a static retractor that is flexible for insertion through a small skin incision and self-supporting once under the skin. The retractor is configured to allow instruments to enter the working cavity along the tendon and may include features to improve access to the tendon. For example, the retractor may include a recess to selectively engage a guide and position the guide along the tendon. When mounted within the retractor, the guide may be configured to guide the cutting trajectory and depth of a double-blade scalpel along the tendon, thereby forming the side of the graft strip. The retractor may also provide access to the proximal end of the tendon, allowing a proximal cutter to transversely cut the proximal end of the graft.
[0008] This document discloses a retractor that is self-supporting to maintain the openness of an anatomical space formed within a patient. The retractor can be configured to maintain the openness of an anatomical space adjacent to a tendon (e.g., a QT), the space being configured for harvesting a tendon graft from a portion of a natural tendon. The retractor can define an elongated body having a proximal end, a distal end, a top defining a curved surface, and a bottom defining a planar surface for engagement with a surface adjacent to the tendon or tissue. The retractor can define an elongated working cavity extending from the open distal end. The top may include at least one opening extending through it, defining the boundaries of bilateral wings at the distal end of the elongated body. The retractor is configured to resiliently contract to be inserted into the skin and into the anatomical space through a relatively small incision. The retractor can be resiliently contracted from a first (neutral) configuration to a second configuration by external force on the bilateral wing body, the second configuration contracting or having a smaller profile than the first configuration. Release of the external force on the retractor is configured to relax the retractor toward the first configuration and maintain the openness of the anatomical space without external support.
[0009] In some exemplary embodiments, the top may include a top notch at the proximal end of the elongated body, the top notch defining a 360-degree bounded aperture configured to increase the flexibility of the retractor and thereby further reduce the contraction profile of the retractor in the second configuration. In some exemplary embodiments, the bottom planar surface includes an elongated opening therethrough, the opening being sized to provide visibility of the entire tendon width and lateral width for tool access. In some exemplary embodiments, the retractor further includes means for engaging and orienting a cutting guide along the working cavity. In this example, the engaging and orienting means may orient the axis of the cutting guide along the working cavity, parallel to the longitudinal axis of the elongated body. In this example, the engaging and orienting means may include a recess extending from the proximal end of the working cavity for receiving the cutting guide end therein. In some exemplary embodiments, the retractor may provide audible feedback when the cutting guide is properly engaged in the recess. In some exemplary embodiments, the distal end of the retractor defines an entrance into the working cavity for simultaneously receiving a guiding tool and a harvesting tool therethrough.
[0010] This document discloses another exemplary embodiment of a self-supporting retractor. The retractor can keep an anatomical space formed within a patient open for tendon harvesting. The retractor may include an elongated body formed of a flexible material and includes a proximal end, a distal end, a longitudinal axis, a top having a curved surface, and a bottom having a planar surface for engaging the tendon surface. The elongated body may define an elongated working cavity extending from the open distal end. The distal end may define bilateral wings having a free distal end. These bilateral wings are configured to press toward each other to temporarily reduce the profile of the retractor for easier insertion through a skin incision. Release of the bilateral wings is configured to relax the wings away from each other, allowing the retractor to stretch and open the anatomical space without external support.
[0011] In some exemplary embodiments, the top may include an elongated top opening defining the top boundaries of the bilateral wings. Squeezing the bilateral wings causes them to move toward each other and into the elongated top opening. In some exemplary embodiments, the retractor includes a top notch at its proximal end defining a 360-degree bounded aperture configured to further reduce the profile of the retractor during insertion through a skin incision. In some exemplary embodiments, the bottom includes an elongated opening therethrough defining the bottom boundaries of the bilateral wings. In some exemplary embodiments, the retractor includes a recess extending from the proximal end of the working chamber for receiving a cutting guide end therein. The retractor may also include a tab opening configured to engage with a cutting guide when the cutting guide engages within the recess, the tab opening being configured to provide audible feedback during engagement. In some exemplary embodiments, the distal end defines an entrance into the working chamber for simultaneously receiving a guiding tool and a collection tool therein.
[0012] An exemplary system for harvesting tendon grafts is also disclosed, comprising a retractor, a guide, and a harvesting tool. The retractor is self-supporting to maintain an open anatomical space formed above the tendon within the patient. The retractor includes a flexible, elongated body comprising a proximal end, a distal end, a longitudinal axis, a curved top, and a bottom having a planar surface for engaging the tendon surface. The retractor defines an elongated working cavity extending from the open distal end. The guide has a handle end, a working end, and an elongated shaft extending therebetween. The guide is configured to assemble with the retractor and fix the guide shaft along the working cavity. The working end of the guide may define an anatomical anterior edge. The harvesting tool includes a handle end and a working end, with the elongated shaft extending therebetween. The working end of the harvesting tool includes a blade edge for cutting into the tendon and a contoured surface for engagement and translation along the guide shaft when in the working cavity. The guide shaft and the contoured surface are configured to limit the range of translation of the harvesting tool along the tendon's trajectory.
[0013] In some exemplary systems, the retractor may include bilateral wings having their free distal ends. The bilateral wings may flex and compress toward each other to temporarily reduce the profile of the retractor for insertion through a skin incision. Release of the bilateral wings is configured to relax the wings laterally away from each other and to stretch and open the anatomical space without external support. The retractor may include a recess extending from the proximal end of the working chamber for receiving the working end of a guide therein and thereby orienting the guide axis along the working chamber. In some exemplary systems, the retractor has a distal opening sized to simultaneously receive both the guide and the acquisition tool therein. Some exemplary systems may also include a proximal cutter configured to extend along the working chamber and transversely cut the tendon graft. Attached Figure Description
[0014] This disclosure will be more fully understood by referring to the following detailed description in conjunction with the accompanying drawings, wherein:
[0015] Figure 1 A schematic diagram of an exemplary tendon acquisition system of this disclosure is shown;
[0016] Figure 2A An isometric view of the retractor according to this disclosure is shown;
[0017] Figure 2B An isometric view of the bottom side of the retractor according to this disclosure is shown;
[0018] Figure 2C An isometric view of the distal end of the retractor according to this disclosure is shown;
[0019] Figure 2D A side view of the retractor according to this disclosure is shown;
[0020] Figure 2E A top view of the retractor according to this disclosure is shown;
[0021] Figure 2F A bottom view of the retractor according to this disclosure is shown;
[0022] Figure 2G A distal view of the retractor according to this disclosure is shown;
[0023] Figure 2H A proximal view of the retractor according to this disclosure is shown;
[0024] Figure 2I A cross-section of the proximal end of the retractor according to this disclosure is shown;
[0025] Figure 2J A cross-section of the proximal end of the retractor according to this disclosure is shown;
[0026] Figure 3The extrusion or contraction configuration of the retractor according to this disclosure is shown;
[0027] Figure 4A An isometric view of the blunt dissector of this disclosure is shown;
[0028] Figure 4B A side view of the blunt dissecter of this disclosure is shown;
[0029] Figure 4C A top view of the blunt dissecting apparatus of this disclosure is shown;
[0030] Figure 4D The proximal end of the blunt dissecter of this disclosure is shown;
[0031] Figure 4E A cross-section of the blunt dissecting axis of this disclosure is shown;
[0032] Figure 5A A side view of a blunt dissecter operatively connected to a retractor according to the present disclosure is shown;
[0033] Figure 5B The proximal end of a blunt dissecter operatively coupled to a retractor according to this disclosure is shown;
[0034] Figure 6A An isometric view of the dual-blade cutter of this disclosure is shown;
[0035] Figure 6B An isometric view of the lower side of the dual-blade cutter of this disclosure is shown;
[0036] Figure 6C A view of the working end of the dual-blade cutter of this disclosure is shown;
[0037] Figure 6D A view of the working end of a dual-blade cutter with blades assembled according to this disclosure is shown;
[0038] Figure 7A A side view of a blunt dissecting instrument and a double-blade cutter relative to each other, and the tendon surface at a distal position along the tendon, is shown according to this disclosure.
[0039] Figure 7B A side view of a blunt dissecting instrument and a double-blade cutter relative to each other, and the tendon surface at a proximal position along the tendon, is shown according to this disclosure.
[0040] Figure 7C The working end of the double-blade cutter relative to the retractor when in a proximal position along the tendon, according to this disclosure, is shown.
[0041] Figure 7DA blunt dissector and a dual-blade cutter relative to each other at the proximal end of the stroke of the dual-blade cutter are shown according to this disclosure, wherein the retractor is removed;
[0042] Figure 7E A cross-sectional view of the blunt dissecting tool axis and the double-blade cutter axis according to the present disclosure is shown when cutting into tendon tissue;
[0043] Figure 7F It shows that it is in Figure 7A Longitudinal cross-sectional view of the blunt dissecter axis and the double-blade cutter axis at the positions shown;
[0044] Figure 7G It shows that it is in Figure 7B Longitudinal cross-sectional view of the blunt dissecter axis and the double-blade cutter axis at the positions shown;
[0045] Figure 8A An isometric view of a proximal cutter with a blade shown in exploded form, according to this disclosure, is shown;
[0046] Figure 8B A side view of a proximal cutter with a blade shown in exploded form, according to this disclosure, is shown;
[0047] Figure 8C A longitudinal cross-sectional view of a blade assembled to a proximal cutter according to the present disclosure is shown;
[0048] Figure 8D An isometric view of the working end of a proximal cutter according to this disclosure is shown, with the blade assembled thereon, and the cutter housing is shown as translucent for ease of understanding;
[0049] Figure 8E A side cross-sectional view of the working end of a proximal cutter according to the present disclosure is shown, with the blade assembled thereon, and the cutter housing is shown as translucent for ease of understanding;
[0050] Figure 8F A side cross-sectional view of the working end of the proximal cutter according to the present disclosure is shown, wherein the blade is assembled thereon, the cutter housing is shown as translucent for ease of understanding, and is in the blade retracted configuration;
[0051] Figure 8G A side view of the proximal cutter handle in a locked configuration according to this disclosure is shown;
[0052] Figure 8H A side view of the proximal cutter handle end according to this disclosure is shown, wherein the handle is unlocked and actuated;
[0053] Figure 9 A top view of a proximal cutter disposed at the proximal end of a retractor, according to the present disclosure, is shown;
[0054] Figure 10 An isometric view of another exemplary retractor for accessing a tendon, according to this disclosure, is shown;
[0055] Figure 11 An isometric view of a retractor assembled with a first modular insert according to this disclosure is shown;
[0056] Figure 12 A view of another double-blade cutter for harvesting tendons, according to this disclosure, is shown;
[0057] Figure 13 An isometric view of a retractor assembled with another modular insert according to this disclosure is shown;
[0058] Figure 14 A view of a proximal cutter for harvesting tendons according to this disclosure is shown;
[0059] Figure 15 A cross-section of a transverse tendon band according to the present disclosure is shown;
[0060] Figure 16A-16J An exemplary method for forming tendon strips from natural tendons using the disclosed system is shown. Detailed Implementation
[0061] In the following description, similar parts have been given the same reference numerals, regardless of whether they are shown in different instances. To illustrate instances clearly and concisely, the figures may not necessarily be drawn to scale, and some features may be shown in a slightly schematic manner. Features described and / or shown with respect to one instance may be used in the same or similar manner in one or more other instances, and / or in combination with or in place of features of other instances.
[0062] As used in the specification and claims, for the purposes of describing and defining the invention, the terms “about” and “approximately” are used to indicate the inherent uncertainty attributable to any quantitative comparison, numerical value, measurement, or other representation. The terms “about” and “approximately” are also used herein to indicate the extent to which a quantitative representation may deviate from the stated reference without causing a change in the essential function of the subject matter under discussion. The plural forms of “comprising,” “including,” and / or each” are open-ended and include the listed portions and may include additional portions not listed. “And / or” is open-ended and includes one or more listed portions and combinations of listed portions. The use of the terms “up,” “down,” “up,” etc., is intended only to help clearly describe the disclosure and is not intended to limit the structure, positioning, and / or operation of the disclosure in any way.
[0063] Now for reference Figure 1 A schematic diagram of an exemplary system 1000 is shown, comprising a retractor 1100 and a plurality of instruments, including but not limited to a blunt dissecter 1200, a double-blade scalpel 1300, and a proximal cutter 1400. All or some portions of the disclosed system can be used in combination with other instruments to harvest tendon strips or grafts from natural tendons. System 1000 is configured to consistently and reliably remove tendon tissue strips from natural tendons according to predetermined strip length, width, and depth. System 1000 may be configured to be positioned between the patient's knee and the quadriceps muscle, located proximally. Therefore, in this disclosure, the term "distal" relative to a portion of the system defines a portion closer to the knee, and the term "proximal" defines a portion of the system closer to the patient's thigh or quadriceps muscle. In other words, in this specification, the terms proximal and distal are patient-related, not instrument-related.
[0064] The system includes a retractor 1100, which is self-supporting and configured to be inserted into a small incision near the knee. The retractor 1100 is preferably placed subcutaneously and along the surface of the quadriceps tendon (hereinafter referred to as "QT"). The retractor is preferably located on the anterior surface of the QT. The retractor 1100 forms a working chamber for accessing and making the QT visible. The retractor 1100 is configured to provide access to the tendon via the working chamber for multiple instruments of the system. The retractor 1100 is configured to keep the working chamber open or to stretch the skin away from the tendon surface without the need for external force, and is therefore self-supporting. Unnecessary external force includes, for example, a positioning arm or support, a robotic arm, or a second person with a paddle retractor. The retractor 1100 is configured to receive and / or operatively engage and guide multiple instruments, such as a dissecter 1200, a harvester 1300, and a proximal cutter 1400, while forming a band of tendon tissue.
[0065] The blunt dissecter 1200 can perform multiple functions, both independently of the rest of the system 1000 and when assembled into the system. For example, the blunt dissecter 1200 can dissect tissue prior to the insertion of the retractor 1100. The blunt dissecter 1200 can also be operatively coupled to the retractor 1100 to provide a handle for retractor insertion and manipulation. The blunt dissecter 1200 can also provide a trajectory guide to limit the trajectory of the harvester 1300. In some system embodiments, the separate tool can dissect tissue first. The harvester 1300 can be configured to use portions of the retractor 1100 and the blunt dissecter 1200 as guides to control the cutting trajectory while simultaneously forming both sides of the tendon band. The proximal cutter 1400 can slide along the working chamber of the retractor and along the partially dissected tendon band, detaching the proximal end of the tendon band from the natural tendon.
[0066] Now turn to the details of the individual components of system 1000, starting with the retractor 1100, at least in Figure 2A-2J Various views are shown. The retractor 1100 can be a monolithic or single molded element formed of flexible material. The retractor is configured to contract or narrow its profile and then be inserted under the skin through an incision. Once inserted, the retractor 1100 is generally self-supporting and configured to keep the anatomical space in which it is inserted open for the performance of minimally invasive surgery. The retractor 1100 defines an elongated body having a proximal and distal end and may have a generally arched or “C”-shaped cross-section defining a channel and longitudinal working cavity along it. The retractor 1100 preferably includes a circular, conical, or streamlined shape along its length to facilitate insertion along the anatomical space anterior to the tendon while minimizing tissue trauma. The proximal end 1110 of the retractor 1100 may be closed, with its profile smaller than that of the distal end 1120. The base of the retractor defines a planar lower surface 1118 along its length to lie relatively flat on the anterior surface of the QT. The QT is not necessarily perfectly flat, but is considered to be substantially planar along its length to engage a large portion of the planar lower surface 1118. The retractor 1100 may be formed of plastic and may be translucent to facilitate better tissue visualization. In addition to being formed of a flexible material, the retractor 1100 includes multiple notches to improve its elastic deformation, making it easier to pass through the incision and insert under the skin. However, the retractor 1100 is rigid enough to return to its undeformed shape once under the skin and push the skin upward to form a tent or working cavity. This provides the surgeon with a working cavity on the target tendon, which can be easily visualized through the incision and the open distal end 1120 of the retractor 1100. The retractor 1100 may include flanges 1117a, 1117b extending radially from the distal end 1120 of the retractor 1100. The flanges 1117a, 1117b may be mirror images of each other on both sides of the longitudinal axis of the retractor 1100 and may extend perpendicular to the longitudinal axis. The flanges 1117a, 1117b can maintain the position of the retractor relative to the skin incision. When the retractor 1100 is inserted, the flanges 1117a and 1117b can remain outside and directly adjacent to the skin incision. The flanges 1117a and 1117b can act as stops to limit the depth of insertion of the retractor 1100 into the anatomical space.
[0067] Retractor 1100 defines a conical proximal end 1110 and a distal end 1120, the distal end defining an opening for the surgeon to directly observe the target tendon and through which instruments are placed. Retractor 1100 can have any length suitable for harvesting QT, and its overall length is generally between 3 and 5 inches, defining a working cavity with a cross-sectional dimension “W” between 1 and 2 inches. Because the skin incision is as small as possible, preferably no more than one inch, the retractor is configured to contract and fit through this small incision, and then spring open once inserted.
[0068] Retractor 1100 may define a housing. Retractor 1100 may include multiple notches 1115 and 1116. Proximal notch 1115 may provide additional retractor flexibility and also provide an access window for optional mirrors or light sources. These optional instruments may extend directly through the skin adjacent to notch 1115 and then through notch 1115. Notch 1115 may define a 360-degree (°) bounded aperture, the boundary of which is entirely defined by retractor 1100. Notch 1115 may be rectangular in shape, having a longer opening dimension across the width of retractor 1100.
[0069] A top notch 1116 extends from the distal end 1120 of the retractor 1100 to and includes its distal edge. Therefore, the top notch 1116 defines a groove with an open distal end. The top notch 1116 may define a boundary with elongated ribs 1119 extending around at least a portion of the boundary of the notch 1116. The ribs 1119 can help further stretch the skin and can add some elasticity to limit skin contraction of the retractor 1100 during insertion. The top notch 1116 defines the inner boundaries of the bilateral wings 1112a, 1112b on both sides of the retractor 1100. The wings 1112a, 1112b can be pinched or squeezed together during insertion into the skin incision. Figure 3 As shown, wings 1112a and 1112b have sufficient flexibility to contact or approach contact to facilitate insertion through a relatively small cut. During compression, wings 1112a and 1112b move into the space of the top notch 1116.
[0070] The puller preferably has a wider cross-sectional width W than QT. Figure 2E To better identify surrounding structures, the retractor 1100 defines an upper curved top portion 1124, bilateral sidewalls 1125a, 1125b (including wings 1112a, 1112b), and bilateral supports 1126a, 1126b. The upper curved top portion 1124 and bilateral sidewalls 1125a, 1125b are configured to lift or stretch the skin. The bilateral supports 1126a, 1126b may define a planar surface of a bottom 1118 that may engage the anterior surface of the QT and tissue lateral to the QT. For access to the anterior QT surface, the bilateral supports 1126a and 1126b are laterally disposed and define an elongated inner opening 1130 along the retractor 1100. The bilateral supports 1126a and 1126b may define a smaller-width opening (G2) toward the proximal end 1110. The narrow opening G2 can be uniform along its entire length and can extend all the way to the proximal end of the retractor 1100. This opening 1130 can restrict the cutting tool along the retractor 1100 and thus along the trajectory of the target tendon. The medial opening 1130 can extend from the most distal edge of the retractor 1100 and along most of the length of the retractor, at least in… Figure 2B and 2F The inner opening 1130 can be best viewed from the center. It can be defined by straight edges 1131a and 1131b parallel to the longitudinal axis LL of the retractor. The inner opening 1130 can extend together with the notch 1115. The inner opening is configured to provide a passage for the collector 1300 to the front surface of the QT.
[0071] At least in Figure 2C , 2G As best seen in 2I, the proximal end 1110 includes a nose 1132 extending proximally from a notch 1115. The nose 1132 includes a recess 1133 continuous with the working cavity. The recess 1133 is configured to selectively engage with the working end of a guide tool (e.g., dissecter 1200). In some embodiments, the guide tool may assist in the insertion and general operation of the retractor 1100. The guide tool may have a handle end opposite the working end, which extends along the retractor 1100 and protrudes from the distal end 1120 of the retractor. Figure 5A and 5B As shown, the recess 1133 can be operatively engaged with a guide tool. The recess 1133 may also include means for reliably engaging with an exemplary tool. The recess 1133 may be sized to slidably receive the working end of the guide tool, except for small gaps at several discrete locations (where the extrusion rib 1137 is located). Figure 2J An exemplary location of the extrusion rib 1137, which may extend a distance along the longitudinal axis, is shown. The extrusion rib 1137 is sized to locally reduce the size of the recess and to more reliably engage the working end of the guide.
[0072] The recess 1133 may also include means for providing the user with reliable audible feedback indicating that the guide tool is properly engaged with the recess 1133. For example, the hole 1134 may snap when a corresponding mating tab engages therein and engages with the hole 1134. The blunt dissector 1200 may include a protruding key or tab received by the hole 1134, at least as shown in the image. Figure 4A As shown in the diagram. Hole 1134 can define an axis perpendicular to the long axis of the retractor. Hole 1134 can combine with a tab on dissecter 1200 to increase the holding force between retractor 1100 and blunt dissecter 1200. Once correctly inserted, auditory feedback or a snapping sensation can compensate for the obscured visibility of the guide tool (dissecter 1200) when retractor 1100 is inserted. Correct insertion of the guide tool (dissecter 1200) is important because it defines the trajectory of the cutting tool into the tendon. Removing dissecter 1200 from retractor 1100 may require deformation of the flexible retractor 1100 adjacent to hole 1134 to remove mating tab 1226 from hole 1134.
[0073] The details of the blunt dissecting instrument 1200 are at least in Figures 4A-4E As shown in the diagram. The blunt dissecter 1200 typically includes a handle end 1210, a working end 1220, and a shaft 1230 extending therebetween. The working end 1220 includes a leading edge 1222, which may be linear and generally blunt over its entire extent, configured to separate tissue layers. The blunt dissecter 1200 can be inserted through an incision near the knee and advanced under the skin to bluntly separate the skin layer from the anterior QT surface. Thus, the leading edge or dissecting edge 1222 is preferably not so sharp as to cut or puncture tissue. However, it may pass through the connective tissue connecting the anterior surface of the QT from the skin layer. The blunt dissecter 1200 may be configured to remove the subcutaneous fat pad. The blunt dissecter 1200 can perform this separation prior to the insertion of the retractor 1100.
[0074] The handle end 1210 can be offset at an angle from the working end 1220. The shaft 1230 may include a bend to form the angular offset. The shaft 1230 defines a distal length portion 1230a extending directly from the handle 1212. The distal length portion 1230a may define a circular first cross-section. The angular offset may be formed along the distal length portion 1230a. The angular offset may be between 140 and 160 degrees and is configured to align with the proximal length portion 1230b along the tendon surface, while angled around a bent knee and not obstructing the path. The proximal length portion 1230b may be non-circular. The proximal length portion 1230b may define a straight length configured to lie on or parallel to a relatively flat QT front surface. The cross-section of the proximal length portion may include at least one planar surface 1233 on its top side, said planar surface extending along the proximal length portion 1230b, such as... Figure 4E As best illustrated. In some embodiments, the cross-section defines an inverted "V" cross-section or an inverted truncated "V". This cross-section, including the planar surface 1233, is configured to engage and guide the translation of a tendon cutting tool, such as a double-blade scalpel 1300, which will be described in more detail later. Other possible configurations for guiding and limiting the trajectory of the cutting tool may include elongated slots or tracks along the dissecter 1200, which operatively engage mating features of the cutting tool.
[0075] The proximal end of the blunt dissector 1200 is shown in more detail in 4D. The proximal length portion 1230b may include a length indicator 1232 to indicate the length of the QT or the insertion depth of the dissector 1200 along the QT. In some embodiments, the working end 1220 may include an indicator or mark (not shown) along the leading edge 1222, traversing the longitudinal axis of the shaft 1230, for estimating the width of the tissue. The working end 1220 may be wider than the shaft 1230 and may be referred to as a scraper. A tapered edge 1225 may extend between the proximal length portion 1230b and the leading edge 1222. The tapered edge 1225 may extend bilaterally from both sides of the shaft 1230 and, in some embodiments, may include a fan-shaped or cutting edge that can dissect connective tissue while the blunt dissector 1200 is retracted (moved distally). The tapered edge 1225 may also limit the trajectory range of the cutting tool, as described later.
[0076] The top side of the working end 1220 may include a tab or key 1226 to reliably engage the mating features of the retractor 1100. The tab 1226 may be rectangular and define a protruding element in the insertion hole 1134. The tab 1226 may define a length smaller than the main length of the hole 1134, allowing some lateral movement between the tab 1226 and the hole 1134 while limiting translation along the longitudinal axis of the retractor. Figure 4E An exemplary cross-section of the proximal portion 1230b of the shaft is shown; it includes a lower side or surface 1231, which may be flat to engage the front surface of the QT. The upper surface 1233 is configured to engage and guide the trajectory of the cutting tool, as will be explained below. The upper surface 1233 may be an inverted "V" shape or a truncated "V" shape, and the shaft portion 1230b may define three surfaces angled relative to each other.
[0077] Figures 5A-5B Various views of the dissecting apparatus 1220 assembled with the retractor 1200 are shown. For ease of understanding, the retractor 1100 is... Figure 5BThe middle part is translucent. The working end 1220 of the blunt dissecter can be selectively received by the recess 1133 of the retractor 1100. The recess 1133 can frictionally engage with the working end 1220. The recess may include a plurality of discrete ribs 1137 to increase the gripping force between the retractor 1100 and the dissecter 1200. The recess 1133 may be sized relative to the working end 1220 such that the retractor 1100 can deform or flex to receive the working end 1220 therein. The recess 1133 and the blunt dissecter 1200 may be coupled to assist the retractor 1100 in insertion along the anterior surface of the QT. Alternatively, the blunt dissecter 1200 may be coupled once the retractor 1100 has been inserted. When inserted along the anterior surface of the QT, the lower surface 1231 may engage a portion of the anterior surface of the QT, and the axial portion 1230b may be aligned with the longitudinal axis or the retractor 1100, and preferably aligned along the target cutting trajectory of the tendon. The blunt dissector 1200 can help move the retractor while identifying the target cutting trajectory.
[0078] Figures 6A-6D Various views of a dual-blade harvester 1300 are shown, configured to simultaneously form both sides of the resulting tendon strip 50′, hereinafter referred to as the “harvester”. Relative to the patient, the harvester 1300 forms two elongated incisions along the tendon 50, including a lateral incision and a medial incision. The harvester 1300 includes a handle 1310 and a working end 1320, with an elongated shaft 1330 therebetween. Both the shaft 1330 and the handle 1310 may extend along the same longitudinal axis. In other words, the handle 1310 and the shaft 1330 may be free from any bending or angular deviation, similar to the blunt dissecter 1200. The handle 1310 and the shaft 1330 may include reusable or multiple-use components with a detachable working end 1320. In some embodiments, the working end 1320 is coupled to the shaft 1330 via a release sleeve (not shown). In other embodiments, the working end 1320 may define a housing 1322 fixedly coupled to the shaft 1330 and include an engagement device 1325 for selective attachment to the blade 1340, such as Figure 6DAs shown in the diagram. The engagement device 1325 may include elongated tabs, each tab on the lateral outer surface of the housing 1322. The engagement device may be oriented at an angle that defines the position of the front cutting edge of the blade 1340, thereby defining the depth of incision into the tendon. The blade 1340 may be a standard surgical scalpel blade. The blade 1340 is preferably disposable, thus ensuring consistent sharpness for each surgery, as sterilization methods for reusable surgical instruments tend to dull sharp edges. The collector 1300 may be provided in various configurations that may define selectable widths and depths through and along the tendon. Different configurations may have different widths and / or different angles at which the blade 1340 is positioned to define the width and depth of the cut through and along the tendon. The two blades 1340 may preferably be parallel to each other and simultaneously form two equal cutting depths within and along the QT. An exemplary lateral distance between the blades 1340 defined by the housing 1322 may be between 5 and 15 mm, and more preferably between 8 and 12 mm.
[0079] Now go to Figure 6B and 6C The housing 1322 defines a lower surface, which may include an elongated channel 1324 having a cross-section in which a proximal guide shaft 1230b is received and operably slidable. The channel 1324 may define a cross-sectional shape that can form a sliding fit with the shaft 1230b of the guide 1200, such as... Figure 7D and 7E As shown in the diagram, channel 1324 can mate with and slide along the mating surface 1233 of the blunt dissector. Channel 1324 and the blunt dissector shaft 1230b are configured to guide the trajectory and cutting depth of the collector 1300, thereby guiding the blade 1340 along the retractor 1100 into the tendon. The lower surface 1231 of the blunt dissector 1200 can engage the anterior surface of the tendon. In other embodiments, only the lower surface of the retractor can engage the anterior surface of the QT. Therefore, the cutting depth D can be defined and controlled by the configuration of the blade 1340, the working end 1320, and the shaft 1230b.
[0080] Figure 7A A retractor 1100 is shown placed on the anterior surface 51 of the tendon, wherein a dissecter 1200 is assembled and inserted into the retractor recess 1133, and a collector 1300 enters the distal end 1110 of the retractor and cuts into the tendon 50. Figure 7B The collector 1300 is shown after translation along the tendon 50 at the proximal end of the retractor 1100. Figure 7C A view of the proximal end 1110 of the retractor is shown, in which the housing 1322 is visible through the notch 1115. Figure 7D It shows a state similar to Figure 7B and 7CThe collector 1300 and dissecter 1200 are shown in the position shown, with the retractor 1100 removed for ease of understanding. In this position, the blunt dissecter 1200 can abut the surface of the collector 1300 to limit the range of the trajectory, thus limiting the translation of the collector proximally. The tapered edge 1225 of the dissecter 1200 can, for example, be configured to limit the trajectory of the collector 1300 by abutting the distal surface 1326 and thereby preventing further translation. In other embodiments, the surface of the retractor can limit the translation of the collector 1300.
[0081] Figure 7F It shows the corresponding Figure 7A The first position is engaged with the cross-section of the collector 1300 of the dissecting device 1200. The collector 1300 may be located at the distal end 1110 of the retractor. Figure 7G It shows the corresponding Figure 7B The second position engages the cross-section of the collector 1300 of the dissecter 1200, wherein the collector 1300 has been translated along the guide 1200 toward the proximal end of the retractor 1100. Figure 7F and Figure 7G By comparison, it can be seen that the collector angle α decreases as the collector 1300 further translates into the working cavity of the retractor. Channel 1324 preferably forms a profile along its longitudinal axis to at least partially compensate for the change in approach angle and maintain a substantially constant cutting depth. For example, in the first position, the collector is oriented with a larger approach angle (angle α) relative to the axis 1230 and the anterior surface 51 of the tendon. The proximal profile surface portion 1324a of channel 1324 (middle) Figure 6C (As shown in the diagram) Engage dissecter axis 1230b. Contour surface portion 1324a may define a convex surface extending coexisting with the blade leading edge 1340a. In a second position, the collector 1300 is oriented with a shallower approach angle (angle α), and the distal contour surface portion 1324b of the channel 1324 engages the dissecter axis 1230b. Contour surface portion 1324b may define linear surfaces axially spaced and remote from the blade leading edge 1340a. As long as the contour surface portions engage the surface 1233 of the dissecter 1200, contour surface portions 1324a and 1324b define the same cutting depth “D”, but the approach angle varies.
[0082] System 1000 may also include a proximal cutter 1400 configured to separate the proximal end of the tendon band from the natural tendon 50, details of which are at least Figures 8A-8EAs shown in the diagram. This cutting operation occurs at the point furthest from the skin incision, making reliable cutting in the target area more difficult to achieve. Without the proximal cutter 1400, the cut end might be uneven, serrated, hindering subsequent suturing and fusion techniques. The proximal cutter 1400 forms a clean and uniform cut end, which makes the later processing of the tendon graft easier. The proximal cutter 1400 includes a replaceable blade 1410, which is selectively and operably coupled to the distal end of the proximal cutter shaft 1440. A new blade 1410 for each procedure ensures a consistently sharp edge and a more consistent and precise uniform slice through the fibrous tendon tissue. Sterilization methods for reusable instruments can dull the sharp edges.
[0083] The proximal cutter 1400 includes a handle end 1430 and a guillotine cutter at a working end 1450 of the cutter 1400. A shaft 1440 extends between the working end 1450 and the handle end 1430. The shaft 1440 may include a length estimation mark along it and may include a static outer shaft and an axially movable inner pull rod 1436, which may be coaxially arranged along the outer shaft. A blade housing 1452 may extend from the shaft 1440. The blade housing 1452 may extend from both sides of the shaft 1440, with the longitudinal axis of the shaft centered relative to the blade housing 1452. The blade housing 1452 may define a longitudinal axis that coincides with and is parallel to the longitudinal axis of the shaft. In other words, the longitudinal axis of the blade housing 1452 is preferably not angularly offset from the longitudinal axis of the shaft.
[0084] Blade 1410 defines a generally thin planar element having a connecting end 1414 and a cutting end 1415 extending therefrom. The cutting end 1415 includes a hole 1412 configured to receive a tendon strip therethrough. The hole 1412 may define a 360-degree (°) bounded opening with curved edges. The hole 1412 may be rectangular and sized to receive a tendon strip including a bone fragment therethrough. Therefore, the hole 1412 may define a cross-section larger than the width or cross-section of the target graft strip because the bone fragment may be slightly larger and more rigid than the graft strip. This is referred to as a full-thickness graft. The hole 1412 may have an effective diameter of up to 12 mm configured to receive both the graft and the bone fragment. The hole boundary may define a sharp arc length 1412a. The arc length 1412a may transition to a less sharp arc length 1412b. Arc lengths 1412a and 1412b may generally face each other, with the sharp arc length 1412a defining the proximal side of the aperture 1412 along the edge furthest from the handle 1430. During operation, the tendon strip slides through the aperture 1412, and the working end 1450 slides along the tendon strip to the proximal end of the prepared tendon strip. Tension on the tendon strip tends to cause it to slide along the distal edge of the aperture 1412 or arc length 1412b when the working end 1450 is positioned. Some weak tissue bridges may be present, forming some hooked discrete connections between the posterior surface of the tendon strip and the anterior surface of the remaining natural tendon. Therefore, although arc length 1412b may preferably not be as sharp as 1412a to avoid any accidental damage to the graft strip when the working end 1450 is placed proximal to the strip, it is preferable that the distal side of the aperture 1412b be configured to break these hooked tissue bridges. Therefore, the arc length 1412b can have a certain sharpness sufficient to rupture these tissue bridges along the tendon when the cutter 1400 is advanced.
[0085] The housing 1452 defines a slot 1454 extending through the longitudinal axis of the housing for receiving a blade attachment end 1414 therein. The blade attachment end 1414 extends through the distal or handle side of the housing 1452 to engage with a pull rod 1436. The housing 1452 may include a curved leading edge 1456, which may be sharp to engage with the blade 1410 when slicing a tendon band. The leading edge 1456 may also be combined with an arcuate aperture length 1412b to aid in severing hooked tissue bridges while advancing the proximal cutter 1400 along the band 50′. The housing 1452 includes an inlet leading to the slot 1454 for receiving the blade 1410 therein. The leading edge of the slot may be asymmetrical, such as... Figure 8EAs best shown, a first distal edge surface 1453 is provided on the first side of the groove, which is tapered and axially spaced from a second distal edge surface 1455. The second distal edge surface 1455 is provided on a second opposite side of the blade 1410 and may extend further along the blade 1410. This offset in the distal edge surfaces (1453, 1455) forms an inlet portion in the blade 1410.
[0086] The housing 1452 includes an arcuate opening at least partially defined by an edge 1456, which approximates the size and shape of the hole 1412. In operation, the cutter 1400 has two configurations. Figure 8D The first configuration shown defines an open configuration for receiving the tendon band through the aperture 1412. When in the target position, retraction of the blade 1410 can move the blade distally, toward the handle, and into the housing 1452 to transection the tendon band. In this second or cutting configuration, the aperture 1412 is preferably reduced to less than zero, such that the arc length 1412a can be recessed or covered by the housing 1452.
[0087] Actuation of the handle 1430 retracts the blade 1410 to cut tendon tissue. The handle 1430 may include two levers 1432a, 1432b pivotally coupled to each other, and may include at least one biasing member 1434 between them. Lever 1432a may be fixed or stationary. Lever 1432b is operatively coupled to a first end of the lever 1436, and actuation (movement) of lever 1432a may axially retract the lever 1436 and thereby retract the blade 1410. The handle 1430 may define a pistol grip handle 1430. Lever 1432b may include a slot 1433 through which a lever pin 1427 is received, such that rotation of lever 1432b toward lever 1432a causes pin 1437 to slide and retract the lever 1436. Releasing the actuating force on lever 1432b causes lever 1432b to spring back, moving blade 1410 to an open configuration via biasing member 1434. The inventors have envisioned other mechanical configurations known in the art that allow the lever to retract. In other embodiments, either or both lever arms can move relative to each other. Activation of the handle is configured to move blade 1410 from a position where a tendon can be received to a position where the housing 1452 covers the entire blade bore 1412. Thus, in some exemplary embodiments, housing 1452 can move, and blade 1410 can remain stationary. In other embodiments, both housing 1452 and blade 1410 can move toward each other.
[0088] The handle 1430 may include a locking element 1455 configured to prevent unintentional actuation of the handle. The locking element 1455 may be operably coupled to a torsion spring 1458 configured to hold the locking element 1455 in a position preventing actuation of the handle 1432b. Figure 8F An exemplary mechanism is shown, illustrating a surface 1457 of a locking member 1455 that can engage a surface 1435b of a handle 1432b, thereby restricting rotation of the handle. Rotation of the locking member 1455 causes surface 1457 to move away from the handle surface 1435b, thus allowing it to be actuated, as... Figure 8G As shown in the image.
[0089] The proximal cutter 1400 defines a longitudinal axis L, and levers 1432a, 14232b extend along a first plane passing through the longitudinal axis L. A housing 1452 defines a maximum width Wm for receiving a corresponding maximum width of the blade 1410 therein. This orients the hole 1412 such that the central axis through the hole 1412 is perpendicular to the first plane. In use, this orientation preferably orients the lever laterally away from the longitudinal axis of the graft strip. Relative to the patient's anatomy, this orients the levers 1432a, 1432b medially or laterally to the patient's anatomy. This lever orientation preferably orients the lever away from the knee joint and out of sight along the tendon 50. Furthermore, the guillotine blade 1410 defines a thin planar element having a planar surface defining the blade thickness, which extends along a plane parallel to the longitudinal axis L. The cutting edge 1412a is axially translated during actuation to move toward the handle end 1430. The cutting edge 1412a moves along a plane parallel to the first plane and parallel to the longitudinal axis L. The cutting edge 1412a defines a segment (arc length) of a 360° (degree) bounded aperture 1412 through the blade thickness, the size of which is defined to pass through the entire cross-section through which the tendon strip 50′ is received. The 360° (degree) bounded aperture 1412 may also include an arc length 1412b, which is configured to anatomical tissue but is not as sharp as the cutting edge. The arc lengths 1412a and 1412b may be opposite each other and may have a range of approximately equal lengths.
[0090] The blade 1410 can operatively engage and disengage from the pull rod 1436. The connecting portion 1414 can extend along a lateral slot of the outer shaft 1440 and selectively engage with the pull rod 1436. The connecting portion 1414 and the pull rod 1436 can include means for selectively engaging and disengaging from each other. The connecting portion 1414 can include at least one lateral tab 1417 that helps disengage the connecting portion 1414 from the pull rod 1436. The connecting portion 1414 can include two tabs 1417. The connecting portion 1414 can include holes 1418 disposed between the tabs 1417 for engaging with a pin or protrusion on the pull rod 1436, such as... Figure 8C The cross-sectional view shown is optimal. One or more tabs 1417 can provide a handle to manipulate the blade 1410, connecting and disconnecting it from the blade 1410 via a lever. Thus, one or more tabs define a boundary with blunt edges and can be held by the user's hand.
[0091] In alternative embodiments, both the housing 1452 and the blade 1410 can be disposable, replaceable sub-assemblies. In some embodiments, the entire cutter 1400 can be disposable. In other embodiments, the blade 1410 can be stationary during cutting, and the housing 1452 can move and advance over the blade 1410.
[0092] The proximal cutter 1400 is configured to fit within the retractor 1100, wherein the guide 1200 and the harvester 1300 are removed. The housing width Wm can approximate the width W of the retractor. The proximal cutter 1400 can slide along the graft strip and along the retractor 1100 to the proximal end of the tendon, as... Figure 9 The best result is shown in the middle.
[0093] Figure 10-15 A second system embodiment configured for tendon harvesting is disclosed. The system includes a retractor 2100 for improving tendon visualization in a manner similar to retractor 1100. System 2000 may also include at least one modular insert (2150, 2200), a dual harvester 2250, and a proximal cutter 2300. Retractor 2100 includes means coupled to the modular insert (2150, 2200) that guides the formation of a consistent graft strip from the natural QT.
[0094] Similar to retractor 1100, retractor 2100 is preferably flexible and retractable, then placed through a subcutaneous incision. Upon release, retractor 2100 forms a “tent” providing the surgeon with visualization of the surgical site. Retractor 2100 may be tapered along its length, having a large distal opening 2120 for inserting instruments and modular inserts. The proximal end 2125 of the retractor may close, preventing tissue and fluid from entering the working chamber 2130. Retractor base 2140 may engage the anterior surface of the QT and may include means for engaging modular inserts (2150, 2200). For example, base 2140 may include a track 2145 therein receiving inserts (2150, 2200) to assist the surgeon in making the incision required for tissue harvesting.
[0095] More specifically, the system may include a retractor 2100, a longitudinal bottom insert 2150, a proximal bottom insert 2200, a dual-blade harvester 2250 used with the longitudinal bottom insert 2200, and a proximal cutter or scalpel 2300 used with the proximal bottom insert 2300.
[0096] One method of use may include making an incision through the patient's skin near the patella and inserting the proximal end 2125 of a retractor 2100 through the incision and advancing it along the anterior surface of the QT. The retractor 2100 may be reduced or constricted in profile to facilitate insertion through a skin incision smaller than the neutral profile of the retractor 2100. The proximal end 2125 may include a lip 2126 that inserts proximally beyond the end of the QT. A retractor base 2140 slides along and rests on the anterior surface of the QT. Advancement occurs until the open end 2120 is adjacent to the initial skin incision and may be inserted externally to the patient's skin or slightly intradermally and subcutaneously while keeping the incision open. This provides improved visibility of the target tissue and improved access for inserting the instrument and modular insert. The longitudinal base 2150 can then be inserted along the base ( Figure 11The bottom 1150 can slide along the track 2145 of the base 2140. The bottom 1150 can be located on the planar surface of the retractor base 2140. The bottom 2150 may include an elongated slot 2142 therethrough, which can be selected according to the desired graft width and length. The bottom 2140 may include a mark 2146 indicating the length. The slot 2142 can define the width and length of the graft and can be of various sizes. A cutting tool or harvester (e.g., harvester 2250) can then be inserted into the working chamber 2130 of the retractor and through the elongated slot 2142 to dissect a portion of the tendon from the natural tendon. The edge surface 2144 of the elongated slot 2142 can guide the trajectory of the harvester 2250. The elongated slot can define a 360-degree bounded aperture, which can limit the translation of the harvester 2250 in the proximal and distal directions.
[0097] Collector 2250 may be a dual-blade tool similar to collector 1300, and may simultaneously form two parallel cuts into and along the QT. The two blades 2252a and 2252b may be parallel to each other and laterally spaced to define the desired width of the QT to be cut. At least one of the blades 2252a or 2252b may slide along one of the edge surfaces 2144 of the groove 2142 to keep the cut aligned along the QT. The planar surface 2254 of collector 2250 may engage with and slide along the top surface 2148 of bottom 2150 to control the depth of cut into the QT.
[0098] The longitudinal base 2150 and harvester 2250 can then be removed from the base 2140 through the distal opening 2120. The posterior aspect of the graft and the patellar end can then be cut using a scalpel to release the QT graft, excluding the proximal end of the remaining graft strip. The proximal base 2200 can then be installed together with the base 2140. Figure 13 The patellar end of the graft can be lifted to slide proximal to the base 220° below the graft tissue at 50′ (see below). Figure 15 The proximal bottom 2200 includes a graft elevation ramp 2220 at the proximal end, the ramp extending at an angle to the bottom 2200. The ramp 2220 extends across the width of the bottom 2200 and includes a groove 2222. The scalpel 2300 can then slide along the top surface of the bottom 2200 and through the groove 2222 to remove the proximal end of the graft 50. The scalpel blade 2320 can be set at a non-zero angle with the shaft and handle, and the blade 2320 can be flush with the underside 2330 to be positioned along the top surface of the bottom 2200.
[0099] Methods of forming grafts in Figure 16A-16J This method can begin by creating a minimally invasive incision at the superior pole of the patella. Figure 16AThe length of the incision 62 can be between 0.5 and 1 inch. A blunt dissecter 1200 can then be inserted through the incision 62 to dissect around the tendon 50. Figure 16B The blunt dissecter 1200 can remove the subcutaneous fat pad. This dissection can be performed before the retractor 1100 is inserted. The dissecting edge 1222 can be configured to separate tissue layers. A length indicator along the axis 1230 of the blunt dissecter 1200 can be used to verify that the tendon 50 has been sufficiently separated from the subcutaneous layer of skin. The blunt dissecter 1200 can then be removed from the subcutaneous layer and can be attached to the retractor 1100. Figure 16C The retractor 1100 may include a recess 1133 configured to receive the working end 1220 of the blunt dissector 1200 therein. The recess 1133 may include a plurality of discrete compression ribs 1137 that form a localized interference fit between the working end 1220 and the recess 1133 to improve grip. Once properly engaged, the user can receive reliable feedback, such as an audible snap. The recess 1133 may include an opening 1134 that receives a tab 1226 upon proper insertion, which inserts into the opening 1134 to provide auditory feedback. The retractor 1100 is preferably formed of a flexible material, and the recess 1133 can be elastically and plastically deformable when operatively coupled to the working end 1220 of the blunt dissector. For example, the compression ribs 1137 can be plastically deformable, while the recess 1133 can be elastically deformable. The blunt dissecter 1200 is coupled to the retractor 1100 such that the guide surface of the blunt dissecter 1200 is oriented along the length of the retractor 1100. The guide surface is configured to guide the trajectory and translation range of the harvesting tool, thereby forming a consistent graft tendon strip. Alternatively, a guide tool different from the blunt dissecter 1200 may be coupled to the retractor 1100 to orient the guide surface along the retractor. For example, a modular insert similar to the bottom 2150 may be operatively coupled to the base of the retractor 1100.
[0100] With the shaft and handle ends of the blunt dissecting instrument 1200 extending from the retractor end 1120, the retractor 1100 can be inserted through the skin incision 62 and along the tendon 50. Figure 16D The retractor 1100 is preferably flexible, and thus, insertion of the retractor 1100 may include using external forces to contract or deform the retractor to fit through a skin incision. These external forces may come from the device, the surgeon's hand, and / or the patient's anatomy. For example, the wings 1112a, 1112b may flex medially during insertion (in... Figure 3(As shown in the diagram). Flexural wings 1112a, 1112b allow the retractor 1100 to reduce its profile and pass through a relatively small incision. The retractor wings 1112a, 1112b can be released primarily once within the subcutaneous layer between the skin 60 and the anterior surface 51 of the tendon and the subcutaneous layer. A blunt dissecter 1200 can be used to position the retractor 1100 along the tendon in a target orientation, wherein the retractor end 1120 is adjacent to or coincides with the skin incision 62. Releasing the external force on the retractor 1100 stretches the skin away from the anterior surface 51 of the tendon. This provides the surgeon with a retraction opening at the skin incision, corresponding to a distal opening 1120 with an expanded working cavity leading to the tendon. Preferably, the retractor 1100 remains stationary and defines a working cavity at least as long as the target tendon strip and wider than the target graft strip width. Preferably, the working cavity is wider than the entire width of the target tendon. Insertion can be completed when the distal radial flanges (1117a, 1117b) are adjacent to incision 62. The flanges 1117a, 1117b can engage the outer surface of the skin, limiting further translation of the retractor under the skin.
[0101] Optionally, the retractor 1100 can be inserted at least partially through the incision without assembling the blunt dissector 1200, and the blunt dissector 1200 can be inserted after the retractor 1100 is substantially in place. When the blunt dissector 1200 is not present, the retractor 1100 can be more fully contracted or narrowed in profile, which can allow the skin incision to remain smaller. Combining the multiple openings and notches through the retractor 1100 with the retractor's flexibility helps to minimize the retractor's profile. According to this exemplary method, the retractor 1100 can be inserted at least partially through the skin incision in a contracted configuration, and once substantially under the skin, it can be released to stretch the skin away from the anterior surface of the QT. The blunt dissector 1200 can then be inserted through the skin incision 62 into the recess 1133 along the retractor 1100. The user can manipulate the dissector 1200 within the recess 1133 until feedback is detected that the indicator tab 1226 has engaged with the opening 1134, thus correctly inserting the blunt dissector 1200 into the recess 1133.
[0102] Optionally, such as Figure 16E As shown, a second port through the skin 60 can be formed at the proximal end of the tendon 50, and a mirror 1500 and / or a light source can be placed through the hole 1115 of the retractor 1100. The target width and depth of the tendon strip can then be determined, and the working end of the collector 1300 can be selected and assembled corresponding to these target values. For example, the collector 1300 can be selected to form two lateral cut surfaces forming the tendon strip 50′, thereby defining a tendon strip width of approximately 8 mm. Other widths may include a 10 mm wide strip or a 12 mm wide strip. The collector 1300 can then be inserted into the working cavity through the retractor end 1120. Figure 16F The collector 1300 engages the axis 1230 of the dissecter 1200 to guide the trajectory of the blade 1340 into and along the tendon 50. This simultaneously forms two sides of the graft strip. The collector 1300 may include a grooved surface 1324 disposed between the two blades 1340, which slides along the upper surface of the dissecter axis 1230 to limit the depth of the incision into the tendon and the trajectory of two lateral incisions along the tendon 50 to the proximal end of the tendon. In other embodiments, the collector 1200 may include a single blade and may form only one side at this stage. As the collector 1300 translates, the dissecter axis 1230 may engage the anterior surface of the tendon 50. The retractor end 1120 allows simultaneous access to both the dissecter 1100 and the collector 1300 while providing visibility of the target tendon through them. The blunt dissecter 1200 may include at least one edge 1225 that limits the extent of the proximal trajectory of the collector. Therefore, the harvester 1300 can slide along the dissecter axis until it abuts the edge 1225. The harvester 1300 can define an arcuate blade edge such that the retraction along the dissecter axis toward the knee can also form the side of the graft strip, or at least separate some remaining tissue bridges between the side of the graft strip and the remaining tendon 50. The harvester channel 1324 can be profiled such that, regardless of the approach angle of the harvester 1300, the depth of the incision into the tendon 50 is relatively consistent along the length of the incision. The harvester 1300 can begin cutting distally at a first approach angle, wherein the distal arcuate profile portion of the channel 1324 engages the axis 1230. As the harvester advances proximally, the approach angle can gradually become shallower such that the linear surface 1324b of the channel 1324 can engage the axis to limit the depth of the cut into the QT.
[0103] Then the dissecter 1200 and collector 1300 can be removed, leaving the retractor 1100 in place. Figure 16F As shown in the illustration, the two lateral surfaces of strip 50′ are now separated from the natural tendon 50. Distal and posterior separation can then be performed, as... Figure 16G As shown, the graft strip 50' is attached to the natural tendon 50 only at its proximal end. This separation can be performed with a scalpel, with the retractor 1100 holding it in place. The distal end of the graft strip can then be passed through the hole 1412 of the proximal cutter 1400. Figure 16H The graft strip can be fed through the orifice 1412 and the working end of the proximal cutter 1400 can extend along the strip through the retractor end 1120 to reach the proximal end of the graft strip, as shown. Figure 16I As shown in the image. Figure 16JA close-up of the proximal incision cutter 1400 is shown, with the graft strip 50' extending through the hole and the retractor 1100 removed for ease of understanding. The lever of the proximal incision cutter 1400 can extend inward or outward from the knee to improve visibility. The locking member 1455 of the proximal incision cutter 1400 can then be moved, actuating the proximal incision cutter 1400 to remove the graft strip 50'. The blade 1410 retracts into the housing 1452 to remove the graft strip 50'. The graft strip 50', proximal incision cutter 1400, and retractor 1100 can then be removed.
[0104] Those skilled in the art will recognize that this disclosure may be practiced in other specific forms without departing from its spirit or essential characteristics. Therefore, the foregoing examples are to be considered illustrative in all respects and not to limit the disclosure described herein. The scope of this disclosure is therefore indicated by the appended claims rather than by the foregoing description, and thus all variations in the meaning and scope of the equivalents of the claims are intended to be included therein.
Claims
1. A self-supporting retractor for maintaining an open anatomical space formed within a patient for harvesting tendons therein, said retractor comprising: An elongated body defining a proximal end, a distal end, a top defining a curved surface, and a bottom defining a planar surface for engaging an anterior surface of a tendon; the elongated body defining an elongated working cavity extending from the distal end. The top includes at least one opening that defines bilateral wings at the distal end of the elongated body, and the at least one opening (1116) defines a groove with an open distal end, wherein the elongated body is configured to elastically contract from a neutral configuration to a contracted configuration by an external force on the bilateral wings for insertion through a skin incision, and upon release of the external force, the elongated body is configured to relax toward the neutral configuration and remain open of the anatomical space without external support.
2. The retractor of claim 1, wherein the top includes a top notch at the proximal end of the elongated body, the top notch defining a 360-degree bounded aperture configured to reduce the profile of the retractor in the contracted configuration.
3. The retractor of claim 1, wherein the bottom includes an elongated opening therethrough, the elongated opening having a width greater than the entire width of the tendon.
4. The retractor of claim 1, further comprising means for engaging the cutting guide and orienting the cutting guide along the working cavity.
5. The retractor according to claim 4, wherein the engaging and oriented means orient the axis of the cutting guide along the working cavity and parallel to the longitudinal axis of the elongated body.
6. The retractor of claim 4, wherein the engaging and oriented means includes a recess extending from the proximal end of the working chamber for receiving the cutting guide end therein.
7. The retractor of claim 6, wherein the retractor is configured to provide auditory feedback when the cutting guide is properly engaged within the recess.
8. The retractor of claim 1, wherein the distal end defines an entrance into the working chamber for simultaneously receiving a guide tool and a collection tool therethrough.
9. A self-supporting retractor for maintaining an open anatomical space within a patient for tendon harvesting, said retractor comprising: An elongated body formed of a flexible material, the elongated body including a proximal end, a distal end, a longitudinal axis, a top having a curved surface, and a bottom having a planar surface for engaging an anterior surface of a tendon, the elongated body defining a working cavity extending from the distal end; The distal end defines bilateral wings with a free distal end, wherein the top (1124) includes an elongated opening (1116) defining the top boundary of the bilateral wings (1112a, 1112b), and the elongated opening (1116) defines a groove with an open distal end, wherein the bilateral wings are configured to press toward each other to temporarily reduce the profile of the retractor for insertion through a skin incision, and upon release, the bilateral wings are configured to relax away from each other, such that the retractor stretches and opens the anatomical space without external support.
10. The retractor of claim 9, wherein the retractor includes a top notch at the proximal end defining a 360-degree bounded aperture, the bounded aperture being configured to increase the flexibility of the retractor and reduce the profile of the retractor during insertion through a skin incision.
11. The puller of claim 9, wherein the bottom includes an elongated opening therethrough, the elongated opening defining the bottom boundary of the dual wings.
12. The retractor of claim 9, further comprising a recess extending from the proximal end of the working chamber for receiving the cutting guide end therein.
13. The retractor of claim 12, wherein the retractor recess includes a tab opening configured to engage with a cutting guide tab, the tab opening being configured to provide auditory feedback when engaged between the tab opening and the tab.
14. The retractor of claim 9, wherein the distal end defines an inlet into the working chamber for simultaneously receiving a guiding tool and a collecting tool therein.
15. A system for harvesting tendon grafts, comprising: The puller according to any one of claims 1-14; A guide that defines a handle end, a working end, and an elongated shaft extending therebetween; The guide is configured to assemble with the retractor and to orient the elongated shaft along the working cavity; A harvesting tool defining a handle end and a working end therebetween, the working end of the harvesting tool including a blade edge for cutting into the tendon and a contour surface for engaging and translating along a guide axis when in the working cavity, the guide axis and the contour surface being configured to cooperate to limit the cutting depth and the range of the blade edge relative to the trajectory and translation of the tendon.
16. The system of claim 15, wherein the retractor includes a recess extending from the proximal end of the working cavity for receiving the working end of the guide therein and thereby orienting the guide shaft along the working cavity.
17. The system of claim 15, wherein the retractor defines a distal opening, the distal opening being sized to receive both the guide and the acquisition tool therethrough.
18. The system of claim 15, further comprising a proximal cutter configured to extend along the working cavity and transversely cut the tendon graft.
Citation Information
Patent Citations
Endoscopic dissector
CN101141921A
Direct vision subcutaneous tissue retractor and method for use
US6196968B1