Surgical driver

Abstract

The present application relates to a surgical driver comprising: a handle having a body, the body having a shaft extending distally therefrom; a driver interface at a distal end of the shaft, the driver interface configured for attachment to a fixture; and a rotatable adjustment mechanism, the rotatable adjustment mechanism being located within the body of the handle.

Description

[0001] This application is a divisional application of the invention application with the application date of August 9, 2019, application number 201980060837.6, and name “Fixation device for tenodesis”. Technical Field

[0002] The present invention relates generally to a surgical system and, more particularly, to an implant and driver for securing soft tissue in a desired position relative to bone. Background Art

[0003] There are several medical procedures in which surgeons need to attach soft tissues such as tendons or other soft connective tissues to bones. A common example is a rotator cuff tear, in which the supraspinatus tendon has been separated from the humerus, causing pain and loss of the ability to raise and externally rotate the arm. In order to repair a torn rotator cuff, surgery is usually used to suture the torn tendon to the bone by a variety of methods. Some surgeries utilize large incisions and involve complete detachment of the deltoid from the acromion. Small diameter holes are made in the bone so that suture material passes through the bone to fix the tendon. Such large incision surgeries are traumatic, resulting in prolonged pain and recovery time. Other surgeries make small incisions and use arthroscopic techniques to attach sutures through small diameter holes or flexible tips. Other injuries requiring similar techniques include biceps tendinitis (e.g., biceps tenodesis surgery) and ACL tearing. In addition, there are enhanced surgeries that require placement of bone tunnels adjacent to other bone tunnels, such as lateral extra-articular tenodesis. In these cases, it is best to have a shallower anchoring device to prevent tunnel convergence.

[0004] Currently, there are a variety of nails and anchoring devices for attaching soft tissue to bone. However, many of these devices suffer from low pull-out strength, lack of adequate suture attachment sites, the need to tie complex knots with sutures, complex threading procedures, the inability to assist the surgeon in positioning the soft tissue in contact with the bone prior to suturing to maximize adhesion of the soft tissue to the bone, and overall difficulty in physically handling these devices during surgery.

[0005] Typically, injuries to joints such as the shoulder and knee involve the tearing of ligaments or separation from their natural position on the bone. The injury results in chronic instability of the joint, which requires surgical intervention. Modern surgical procedures involve the use of one or more arthroscopic devices. These devices include a surgical cannula through which a camera or surgical device is passed. Arthroscopic methods generally reduce trauma to the patient than previous methods, and a faster recovery can be expected.

[0006] In short, the surgical procedure involves visualization and localization of the injury, preparation of the bone surface, implantation of the soft tissue anchors, and suturing of the tissue to the anchors. By bringing the ligament or other soft tissue into close contact with the properly prepared bone surface, the two materials bond together during the healing process.

[0007] Fixing devices are often used during such surgical procedures to fix soft tissue to bone. Fixing devices such as implants are often inserted into a prepared bone socket so that sutures can extend from the bone socket to be sutured to the soft tissue. A driver is used to insert and impact the implant into the bone socket. Conventional drivers may damage the implant due to the impact force. In addition, some drivers do not have a mechanism that can be used to organize and tension the suture. Therefore, the surgical procedure may take more time.

[0008] Therefore, there is a need for an implant that is securely grasped on a soft tissue graft for insertion into a prepared bone socket, and a driver for inserting and impacting the implant into the prepared bone socket.

[0009] Related Art Section Disclaimer Description: With respect to specific patents / publications / products discussed above in the Related Art Section Description or elsewhere in this disclosure, such discussion should not be considered an admission that the discussed patents / publications / products are prior art for patent law purposes. For example, some or all of the discussed patents / publications / products may not be sufficiently early in time, may not reflect subject matter that was developed early enough in time, and / or may not be sufficient to achieve prior art equivalents for patent law purposes. With respect to specific patents / publications / products discussed above in the Related Art Section Description and / or throughout the application, their descriptions / disclosures are incorporated herein by reference in their respective entireties. Summary of the invention

[0010] Embodiments of the present invention relate to a surgical fixation device and a driver for fixing soft tissue in a desired position relative to bone. According to one aspect, the present invention is a surgical fixation device. The fixation device includes a forked upper portion having two or more arms extending proximally from the forked upper portion to the top surface of the upper portion. Each of the two or more arms constitutes a side of the upper portion. The sides of at least two of the two or more arms are opposite sides. The flange extends outward around each of the opposite sides. The fixation device also includes a forked lower portion having two or more legs extending distally from the forked lower portion, and there is a space between at least two of the two or more legs.

[0011] According to another aspect, the fixture may include a forked lower portion having two or more legs extending distally therefrom with a space between at least two of the two or more legs. The fixture may also include an upper portion having a top surface and two or more side surfaces. At least two of the two or more side surfaces have a first slot extending therebetween. Additionally, the fixture has a central hole extending into the top surface of the upper portion and through the lower portion.

[0012] According to another aspect, the present invention is a surgical driver. The driver has a handle having a body having a shaft extending distally therefrom. The driver interface at the distal end of the shaft is configured for attachment to a fixture. The driver also includes a rotatable adjustment mechanism located within the body of the handle.

[0013] These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] One or more aspects of the present invention are particularly pointed out and clearly claimed as examples in the claims at the end of the specification. The foregoing and other objects, features and advantages of the present invention will become apparent from the following description in conjunction with the accompanying drawings, in which:

[0015] Figure 1 is a schematic side view of a fixing device according to one embodiment;

[0016] Figure 2 is a top schematic view of a fixing device according to one embodiment;

[0017] Figure 3 is a perspective schematic diagram of a fixation device used in a pre-deployment configuration according to one embodiment;

[0018] Figure 4 is a perspective schematic diagram of a fixture for use in a deployed configuration according to one embodiment;

[0019] Figure 5 is a schematic cross-sectional side view of a fixture for use in a deployed configuration according to one embodiment;

[0020] Figure 6 is a schematic top view of a fixing device according to an alternative embodiment;

[0021] Fig. 7A is a perspective schematic diagram of a press-fit driver interface according to one embodiment;

[0022] Figure 7B is a perspective schematic diagram of a threaded driver interface according to one embodiment;

[0023] Figure 7C is a perspective schematic diagram of a slotted drive interface according to one embodiment;

[0024] Fig.7D is a perspective schematic diagram of a keyed actuator interface according to one embodiment;

[0025] Figure 8 is a schematic side view of a fixing device according to an alternative embodiment;

[0026] Fig. 9 yes Figure 8 A front view schematic diagram of a fixing device;

[0027] Fig.10 yes Figure 8 A top view schematically showing a fixing device;

[0028] Fig.11 is a schematic side perspective view of a driver according to one embodiment;

[0029] Fig.12 According to an implementation scheme Fig.11 A perspective schematic diagram of a drive of the invention, the drive being loaded with a fixture;

[0030] Fig.13 According to an implementation scheme Fig.11 A partial exploded schematic diagram of an adjustment mechanism of a driver;

[0031] Fig.14 is a top perspective schematic diagram of a distal end of a handle of a driver according to one embodiment;

[0032] Fig.15 is a schematic top view of a spinning reel according to one embodiment;

[0033] Fig.16 is a schematic side view of a spinning reel according to one embodiment;

[0034] Fig.17 is a top perspective schematic diagram of a cover on a handle of a driver in a closed position according to one embodiment;

[0035] Fig.18 According to an implementation scheme Fig.17 A top perspective schematic diagram of a cover on a handle of a driver in an open position;

[0036] Fig.19 is a top perspective schematic diagram of a cover on a handle of a driver in a closed position according to an alternative embodiment; and

[0037] Fig. 20 According to an alternative embodiment Fig.19 A top perspective schematic diagram of a cover in an open position on the handle of a driver. DETAILED DESCRIPTION

[0038] Aspects of the present invention and certain features, advantages and details thereof are explained more fully below with reference to the non-limiting examples shown in the accompanying drawings. Descriptions of known structures are omitted so as not to unnecessarily obscure the present invention in detail. However, it should be understood that the detailed description and specific non-limiting examples, although indicating aspects of the present invention, are given only in an illustrative manner, rather than in a limiting manner. Various substitutions, modifications, additions and / or arrangements within the spirit and / or scope of the basic concepts of the present invention will be apparent to those skilled in the art in light of this disclosure.

[0039] Referring now to the drawings, wherein like reference numerals refer to like parts throughout, Figure 1 A schematic side view of a fixation device 100 according to one embodiment is shown. The fixation device 100 is a solid surgical implant. The fixation device 100 can be made of metal and / or polymer materials. The fixation device 100 includes an upper portion 102 and a lower portion 101. The upper portion 102 is wider than the lower portion 101 because the size and configuration of the lower portion 101 is designed to be inserted into a prepared bone socket.

[0040] like Figure 1 As shown, the lower portion 101 is forked so that a plurality of legs 104 extend therefrom. In the depicted embodiment, the lower portion 101 includes two legs 104. Each of the plurality of legs 104 terminates in a sharp edge 105. The sharp edge 105 helps the fixation device 100 grip the prepared bone socket. When the lower portion 101 is forked, there is a space 106 between at least two of the plurality of legs 104. The size and configuration of the space 106 are designed to accommodate soft tissue.

[0041] Still see Figure 1 , the upper portion 102 of the fixation device 100 is also forked, so that a plurality of arms 108 extend therefrom. In the depicted embodiment, the upper portion 102 includes two arms 108. Each of the plurality of arms 108 includes an outer flange 107. The flange 107 is located below the top surface 109 of the upper portion 102. In other words, the flange 107 is located between the top surface 109 and the lower portion 101. In one embodiment, the flange 107 is a few millimeters from the top surface 109 to provide fixation below the dense cortical layer of the bone.

[0042] Now go to Figure 2 , shows a top view schematic diagram of a fixing device 100 according to one embodiment. Figure 2 As shown, flange 107 extends outwardly from arm 108. Fixation device 100 also includes one or more material releases 110 located in upper portion 102. In the depicted embodiment, fixation device 100 includes two releases 110, and the releases 110 are located on opposite sides 112, 114 of fixation device 100. Using the releases 110 located on opposite sides 112, 114 of fixation device 100, soft tissue is moved downward from one side 112 and then reaches space 106 ( Figure 1 ) below and then return upward to the opposite side 114.

[0043] See now Figures 3 to 5 , showing various perspective and side views of a fixation device 100 in use according to one embodiment. Prior to using the fixation device 100, a bone socket 201 of appropriate size is prepared in a bone 200. Thereafter, the fixation device 100 is loaded onto the soft tissue 203 and positioned above the prepared bone socket 201, as shown in FIG. Figure 3 Soft tissue 203 is located in the space 106 between the legs 104 of the lower portion 101 of the fixation device 100. Note that the size and configuration of the lower portion 101 is designed to fit within the prepared bone socket 201. The sides 112, 114 of the upper portion 102 of the fixation device 100 are slightly released (via Figure 2 The release portion 110 in the bony socket 201 is provided to allow the fixation device 100 to extend from the prepared bone socket 201, but to provide compression once secured.

[0044] Figure 4 The fixture 100 is shown being impacted into the prepared bone socket 201. When the upper portion 102 of the fixture 100 is impacted into the prepared bone socket 201, the upper portion 102 is compressed. The compression causes the leg 104 to rotate outward around the soft tissue 203 (like a fulcrum), as shown in FIG. Figure 5 The outward deformation of the legs 104 allows the fixation device 100 to be anchored in the prepared bone socket 201. As described above, the sharp edge 105 of each leg 104 is caught on the prepared bone socket 201, thereby facilitating anchoring.

[0045] Now go to Figure 6 , shows a top view schematically showing a fixing device 100 according to an alternative embodiment. Figure 6 In the illustrated embodiment of the fixture 100, the top surface 109 of the upper portion 102 includes a connection feature 116 ( FIG. 7A to FIG. 7DIn one embodiment, the connection feature 116 is a hole. When the connection feature 116 is a hole, the fixture 100 can be engaged with various driver interfaces 12 at the distal end 14 of the driver 10, such as FIG. 7A to FIG. 7D shown.

[0046] Fig. 7A The illustrated driver interface 12 is a press-fit attachment that is sized and configured to fit within the aperture 116 . Figure 7B The illustrated driver interface 12 is a threaded attachment that is also sized and configured to fit within the bore 116; however, the bore 116 has complementary threads (not shown). Fig.7D The driver interface 12 is shown as a keyed attachment that is sized and configured to engage Figure 6 The connection feature 116 is shown. Figure 6 The illustrated connection feature 116 is a hole 116 and an elongated recess 118 extending through the hole 116 across the top surface 109 of the upper portion 102 . Fig.7D The driver interface 12 in FIG. 1 is sized and configured to fit within the aperture 116 and the elongated recess 118. Figure 7C , the driver interface 12 is slotted or includes a slotted attachment including one or more slots 16 extending along the distal end 14 of the driver 10. The driver 10 having slots 16 is preferably used with a suture (not shown), as described in detail below.

[0047] See now Figures 8 to 10 , various schematic diagrams of a fixing device 100 according to an alternative embodiment are shown. Figure 8 and Fig. 9 Shown are side and front views of fixture 100. Fixture 100 includes one or more ribs 120 extending across the sides 112, 114 of upper portion 102. Ribs 120 increase the surface contact area and extend over fixture 100. In addition, ribs 120 increase the load distribution on the bone and accommodate varying cortical thicknesses. In the depicted embodiment, at least one of the ribs extends in a plane substantially parallel to the top surface 109 of upper portion 102.

[0048] Fig.10 A schematic top view of the fixing device 100 is shown. The upper portion 102 includes one or more release slots 122. Fig.10 In the embodiment shown, the top surface 109 of the upper portion 102 has two release slots 122. The two release slots 122 are located on opposite sides of the hole 116. Fig.10As shown, the release slot 122 is configured radially around the hole 116 to optimize the wall thickness of the driver interface 12 to accommodate a larger driver interface 16 (e.g., Fig.7D ). This, in turn, provides sufficient clearance to contain a suture passing through the central hole 116 while maintaining sufficient strength of the driver interface 12.

[0049] Now go to Figures 11 to 20 , various schematic diagrams of the driver 10 and its components are shown according to one embodiment. Fig.11 A schematic side perspective view of a driver 10 is shown, the size and configuration of the driver being designed to impact a fixture 100 into a prepared bone socket 201 having a defined diameter and depth ( Figures 3 to 5 ). The driver 10 includes a proximal end 18 and a distal end 14. The proximal end 18 includes a handle 20 connected to a shaft 22 that extends from the handle 20 to the distal end 14. The shaft 22 allows for axial impact to insert the fixture 100. The handle 20 can be curved and ergonomically shaped for comfortable use.

[0050] like Fig.11 As shown, the shaft 22 extends to a stop 24 at the distal end 14. In the depicted embodiment, the stop 24 is a positive stop that is sized and configured to be used at a predetermined position relative to the fixture 100. The positive stop 24 controls the insertion depth of the fixture 100 to ensure that the top surface 109 of the fixture 100 is relatively flush with the outer cortical layer of the bone. Fig.11 As shown, the positive stop 24 is formed of a flexible member such as an O-ring. In the depicted embodiment, the positive stop 24 is an O-ring having an outer diameter greater than the outer diameter of the shaft 22. The O-ring serves as an indicator as to when the proper anchor insertion depth is reached while preventing damage to the cortex when the driver 10 strikes the bone.

[0051] Fig.12 A perspective schematic diagram of a driver 10 according to an alternative embodiment is shown. In the depicted embodiment, a fixation device 100 is attached to the distal end 14 of the driver 10. The fixation device 100 has one or more sutures 300 threaded or otherwise attached thereto to capture soft tissue, suture the soft tissue to the fixation device 100, or tie off a portion of a fixed tendon above the top surface 109 of the upper portion 102 of the fixation device 100. The driver 10 may also include one or more slots 26 along at least a portion of the length of the shaft 22 (see Fig.7D The slot 16 in the Fig.12 In the embodiment, the driver 10 has two slots 26. The two slots 26 extend along at least a portion of the shaft 22 on opposite sides of the driver 10. Specifically, Fig.12The slot 26 is shown to be substantially aligned with the sides 112 , 114 of the fixture 100 .

[0052] Still see Fig.12 , the size and configuration of the slot are designed to receive the suture 300. The suture 300 extends from the lower portion 101 of the fixation device 100. Specifically, the suture 300 is folded to form a distal loop 302 having two branches 304, 306 extending proximally therefrom. The distal loop 302 extends from the lower portion 101, and the two branches 304, 306 extend through the fixation device 100 and then through the hole 116 ( Fig.10 ), and leaves the drive 10 through the slot 26, as Fig.12 As shown. Therefore, the branches 304, 306 can freely travel within the space 106 of the fixture 100 and along the axis 22. In one embodiment, the branches 304, 306 are collected and tensioned at the adjustment mechanism 28 of the handle 20.

[0053] Now go to Fig.13 , shows a partially exploded schematic diagram of the adjustment mechanism 28 of the driver 10 according to one embodiment. The adjustment mechanism 28 in the handle 20 of the driver 10 is rotatable. Specifically, the adjustment mechanism 28 is a winding wheel 30 located in a cavity 32 of the handle 20, such as Fig.13 The branches 304, 306 of the suture 300 extend along the shaft 22 and are coupled to the adjustment mechanism 28 (winding wheel 30), as shown. Fig.12 The winding wheel 30 can be rotated clockwise to increase the size of the distal ring 302, and can be rotated counterclockwise to reduce the size of the distal ring 302 (and vice versa). Therefore, the adjustment mechanism 28 is used to adjust the size of the distal ring 302.

[0054] Now go to Figures 14 to 16 , various schematic diagrams of the adjustment mechanism 28 of the handle 20 are shown according to one embodiment. Fig.14 A close-up top view of the adjustment mechanism 28 of the handle 20 is shown. Fig.14 As shown, the distal end 34 of the handle 20 includes a slot 36 located in the body 21 of the handle 20. The slot 36 begins at or near the distal end 34 of the handle 20 and extends to the adjustment mechanism 28. In some cases, the slot 36 extends to the cavity 32 in the handle 20. The slot 36 allows the suture 300 (and in some cases, the needle attached thereto) to be separated from the handle 20.

[0055] Fig.15 A schematic top view of the winding wheel 30 is shown, and Fig.16 30. The winding wheel 30 includes a slot 38. The slot 38 extends through the top surface 40 of the winding wheel 30, as shown in FIG. Fig.15 and Fig.16 The narrow groove 38 allows the suture 300 to be wound around the central hub 42 ( Fig.15 The narrow slot 38 also allows the suture 300 to be wrapped around the winding wheel 30 and released from the winding wheel 30.

[0056] See now Figures 17 to 20 , showing a plurality of top perspective schematic views of the handle 20 of the driver 10 according to one embodiment. Fig.17 and Fig.18 A top perspective view of the handle 20 of the driver 10 with a flip-top (or rotatable cover) 44 is shown. Fig.17 As shown, the handle 20 includes a cover 44 that is flush with the body 21 of the handle 20 in the closed position. Fig.18 As shown, the cover 44 is rotated in a direction away from the body 21 of the handle 20, thereby exposing a compartment 46 within the handle 20. The compartment 46 extends into the body 21 of the handle 20. In the depicted embodiment, the cover 44 is rectangular, but any suitable geometric shape may also be used. The size and configuration of the compartment 46 are designed to accommodate or otherwise contain a needle (not shown) for suturing the suture 300. The needle is typically attached to the ends of the branches 304, 306 of the suture 300 to facilitate the ability to suturing the suture 300 to additional soft tissue to be fixed to the fixation device 100.

[0057] Fig.19 and Fig. 20 A top perspective view of the handle 20 of the driver 10 with the slide cover 44 is shown. Fig.19 As shown, the handle 20 includes a proximal cover 44 that is flush with the body 21 of the handle 20 in the closed position. Fig. 20 As shown, the cover 44 slides away from the body 21 of the handle 20 in the proximal direction, thereby exposing the compartment 46 within the handle 20. The compartment 46 extends into the body 21 of the handle 20. In the depicted embodiment, the cover 44 is rectangular, but any suitable geometric shape may be used. For the reasons described above, Fig.19 and Fig. 20 The illustrated compartment 46 is sized and configured to store a needle. Since the compartment 46 is out of the user's hand during insertion of the fixture 100, the compartment 46 is a safe location for storing a needle.

[0058] All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and / or ordinary meanings of the defined terms.

[0059] Although various embodiments have been described and shown herein, a person of ordinary skill in the art will readily conceive of various other devices and / or structures for performing functions and / or obtaining results and / or one or more of the advantages described herein, and each of such variations and / or modifications is considered to be within the scope of the embodiments described herein. More generally, it will be readily understood by those skilled in the art that all parameters, dimensions, materials, and configurations described herein are exemplary, and that actual parameters, dimensions, materials, and / or configurations will depend on the teachings of the present invention for one or more specific applications thereof. Using only routine experiments, those skilled in the art will recognize or be able to determine many equivalents of the specific embodiments described herein. Therefore, it should be understood that the foregoing embodiments are given only by way of example, and within the scope of the appended claims and their equivalents, embodiments may be practiced in a manner different from that specifically described and protected by the claims. The embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, if these features, systems, articles, materials, kits, and / or methods are not mutually contradictory, any combination of two or more such features, systems, articles, materials, kits, and / or methods is also included within the scope of the present disclosure.

[0060] The terms used herein are only used for the purpose of describing specific embodiments and are not intended to limit the present invention. As used herein, unless the context clearly indicates otherwise, the singular forms "a", "an" and "the" are also intended to include plural forms. It should also be understood that the terms "comprise" (and any form of "comprise", such as "comprises" and "comprising"), "have" (and any form of "have", such as "has" and "having"), "include" (and any form of "include", such as "includes" and "including"), and "contain" (and any form of "contain", such as "contains" and "containing") are open-ended copulas. Therefore, "including", "having", "including" or "containing" a method or device of one or more steps or elements. Likewise, a method step or an apparatus element that "comprises," "has," "includes," or "contains" one or more features has those one or more features, but is not limited to having only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed.

[0061] All means or steps in the claims plus corresponding structures, materials, operations, and equivalents of functional elements, if any, are intended to include any structure, material, or operation for performing a function in combination with other claimed elements as specifically claimed. The description of the present invention has been given for the purpose of illustration and description, but the description is not exhaustive or limits the invention to the disclosed form. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiments are selected and described in order to best explain the principles and practical applications of one or more aspects of the invention, and to enable others of ordinary skill in the art to understand one or more aspects of the invention for various embodiments with various modifications suitable for the specific purposes contemplated.

Claims

1. A surgical driver comprising: a handle having a body with a shaft extending distally therefrom; a driver interface at a distal end of the shaft, the driver interface configured for attachment to a fixture; as well as A rotatable adjustment mechanism is located within the body of the handle.

2. The surgical driver of claim 1, further comprising one or more slits extending proximally from the distal end of the shaft along at least a portion of the shaft.

3. The surgical driver of Claim 1 wherein said adjustment mechanism comprises a winding wheel positioned within a recess of said body of said handle.

4. The surgical driver of claim 3, further comprising a slot located at or near a proximal end of the body of the handle, the slot extending to the recess.

5. The surgical driver of claim 3, further comprising a slot extending through a top surface of the winding wheel.

6. The surgical driver of claim 1 further comprising a compartment within said body of said handle.

7. The surgical driver of claim 6, further comprising a removable cover attached to the body of the handle, wherein in an open position the cover exposes the compartment and in a closed position the cover conceals the compartment.

8. The surgical driver of claim 7 wherein said cover is rotatable away from said body of said handle.

9. The surgical driver of claim 7 wherein said cover is slidable along said body of said handle.

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