Suture anchor insertion assembly and method of use

Abstract

A suture anchor insertion assembly includes a needle pre-attached to a suture or suture tape, the needle being located within a housing of an inserter. The suture extends around a suture bridge of a suture anchor having at least one rib extending through an interior volume. An outer surface of a shaft of the inserter includes a groove sized to receive both the rib of the suture anchor and a length of the suture while still allowing the suture to slide relative to the inserter.

Description

TECHNICAL FIELD

[0001] The present disclosure relates to surgical repair of tissue, and more particularly to devices and methods for inserting suture anchors used in such repairs. BACKGROUND

[0002] During surgical repair of tissue, surgeons often use suture anchors to attach tissue or tissue grafts to bone. Typically, the surgeon uses an inserter tool to implant a suture anchor into a drilled hole in the bone. In some cases, the surgeon also connects one or more sutures or suture tapes having attached needles to the suture anchor. The surgeon uses the needles to thread the sutures through the tissue and subsequently ties the sutures to secure the tissue to the bone.

[0003] Some suture anchor inserters store both a portion of the suture and a pre-attached needle within the handle, allowing the user to easily deploy. Additionally, such inserters provide tension on the suture, allowing the suture anchor to remain engaged with the inserter during the repair. However, pre-attaching the needle to the suture and storing it within the inserter presents problems. The needle cannot pass through the center of the shaft without requiring an open slot in the shaft, which can weaken the insertion properties of the inserter. Additionally, misalignment of the inserter with the suture anchor and improper sizing or bulk of the suture and / or suture tape can prevent the suture from sliding after the suture anchor is inserted into the bone. SUMMARY

[0004] The suture anchor insertion assemblies described herein include a needle pre-attached to a suture or suture tape, which is located within the housing of the inserter. The suture extends around a suture bridge of the suture anchor, which has at least one rib extending through an interior volume. The outer surface of the shaft of the inserter includes a groove sized to receive both the rib of the suture anchor and a length of the suture, while still allowing the suture to slide relative to the inserter. In comparison to current assemblies, the suture anchor insertion assemblies of the present disclosure advantageously allow for the use of larger cross-sectional areas and quantities of suture or suture tape without requiring external voids in the shaft of the inserter, which can increase the risk of insertion failure.

[0005] Other examples of suture anchor insertion assemblies and methods of the present disclosure can include one or more of the following in any suitable combination.

[0006] In an example, a suture anchor insertion assembly of the present disclosure includes a suture anchor having a body with a proximal end and a distal end. The body defines an interior volume. At least one rib extends through the interior volume between the proximal end and the distal end of the body. The suture anchor insertion assembly further includes an inserter having a handle assembly and a shaft extending from the handle assembly. An outer surface of the shaft defines at least one channel extending along a length of the shaft. A distal end of the shaft is configured for insertion within the interior volume of the suture anchor. The suture anchor insertion assembly further includes a flexible member having at least one leg. The at least one leg includes an end region coupled to a needle disposed within a proximal component of the handle assembly. The suture anchor is disposed on the distal end of the shaft such that the at least one rib engages the at least one channel and the at least one leg of the flexible member extends through the interior volume of the suture anchor and along the at least one channel.

[0007] In other examples, the body of the suture anchor has a plurality of turns of thread extending from the proximal end to the distal end of the body, the orifice being defined by spaces between the plurality of turns of thread. In an example, the body of the suture anchor further includes a suture bridge at the distal end of the body. The flexible member extends around a distal end of the suture bridge. In an example, the distal end of the shaft includes an open slot defined between prongs extending proximally, and a partition member extending proximally from the open slot. The suture bridge is positioned within the open slot such that a proximal end of the suture bridge is adjacent to a distal end of the partition member. In an example, the at least one rib, the partition member, and a sidewall of the distal end of the shaft define at least one passageway for the at least one leg of the flexible member to pass through the interior volume of the suture anchor. In an example, a cross-section of the partition member has a jigsaw cut. In an example, a central component of the handle assembly is configured to rotate relative to the proximal component of the handle assembly to release the end region of the flexible member and the needle from the handle assembly, and / or to release the at least one leg of the flexible member from the at least one channel of the shaft. In an example, an additional flexible member is attached to the at least one leg of the flexible member. In other examples, another leg of the flexible member is attached to the at least one leg of the flexible member.

[0008] In an example, a method of the present disclosure of inserting a suture anchor into bone includes inserting a suture anchor into a suture anchor insertion assembly into bone. The suture anchor insertion assembly includes a suture anchor having a body with a proximal end and a distal end. The body defines an interior volume. At least one rib extends through the interior volume between the proximal end and the distal end of the body. The suture anchor insertion assembly further includes an inserter having a handle assembly and a shaft extending from the handle assembly. An outer surface of the shaft defines at least one channel extending along a length of the shaft. A distal end of the shaft is configured for insertion within the interior volume of the suture anchor. The suture anchor insertion assembly further includes a flexible member having at least one leg. The at least one leg includes an end region coupled to a needle disposed within a proximal component of the handle assembly. The suture anchor is disposed on the distal end of the shaft such that the at least one rib engages the at least one channel and the at least one leg of the flexible member extends through the interior volume of the suture anchor and along the at least one channel. The central component is rotated relative to the proximal component of the handle assembly and the inserter is removed from the bone.

[0009] In an example, the rotation of the central component relative to the proximal component releases the end region of the flexible member and the needle from the proximal component of the handle assembly and / or the at least one leg of the flexible member from the at least one channel of the shaft of the handle assembly. In an example, the body of the suture anchor has a plurality of turns of threads extending from the proximal end to the distal end of the body, the orifices being defined by spaces between the plurality of turns of threads. In an example, the body of the suture anchor further includes a suture bridge at the distal end of the body. The flexible member extends around the distal end of the suture bridge. In an example, the distal end of the shaft includes an open slot defined between prongs extending proximally, and a partition member extending proximally from the open slot. The suture bridge is positioned within the open slot such that a proximal end of the suture bridge is adjacent to a distal end of the partition member. In an example, the at least one rib, the partition member, and a sidewall of the distal end of the shaft define at least one passageway for the at least one leg of the flexible member to pass through the interior volume of the suture anchor. In an example, the partition member has a puzzle cut cross-section.

[0010] In an example, the kit for surgical repair disclosed herein includes a suture anchor insertion assembly comprising a suture anchor having a body with a proximal and a distal end. The body defines an internal volume. At least one rib extends through the internal volume between the proximal and distal ends of the body. The suture anchor insertion assembly also includes an inserter having a shank assembly and a shaft extending from the shank assembly. An outer surface of the shaft defines at least one channel extending along the length of the shaft. The distal end of the shaft is configured for insertion into the internal volume of the suture anchor. The suture anchor insertion assembly also includes a flexible member having at least one leg. The at least one leg includes an end region that engages with a needle disposed within a proximal portion of the shank assembly. The suture anchor is disposed on the distal end of the shaft such that at least one rib engages at least one channel, and at least one leg of the flexible member extends through the internal volume of the suture anchor and along at least one channel. The kit also includes another suture anchor insertion assembly different from the suture anchor insertion assembly, and a drill. In an example, the kit also includes a guide.

[0011] The advantages of these and other features will become clear from reading the following detailed description and consulting the accompanying drawings. The foregoing general description and the following detailed description are for illustrative purposes only and do not limit the aspects of the claimed disclosure. Attached Figure Description

[0012] This disclosure will be more fully understood in conjunction with the following detailed description and accompanying drawings, wherein:

[0013] Figure 1 An example of the suture anchor insertion assembly of this disclosure is shown in an assembled view;

[0014] Figure 2A -C shows Figure 1 An example of an inserter for a suture anchor insertion assembly;

[0015] Figure 3A It shows Figure 1 An example of a suture anchor insertion component;

[0016] Figure 3B It shows the relationship with Figure 3A An example of an inserter used in conjunction with suture anchors at the distal end;

[0017] Figure 3C It shows Figure 3A suture anchors and Figure 3B Components of the inserter;

[0018] Figure 3D It shows Figure 3C The cross-section of the component;

[0019] Figure 4A and 4B Another example of a suture anchor / insertor assembly (100) and the distal end (102) of its insertor is shown; Figure 4A Figure 4B

[0020] Figure 5A and 5B Another example of a suture anchor / insertor assembly (100) and the distal end (102) of its insertor is shown; Figure 5A Figure 5B

[0021] Figure 6A and 6B Other examples of suture anchor / insertor assemblies are shown;

[0022] Figure 7A -C shows a method of attaching additional sutures to the suture anchor insertion assembly of Figure 1

[0023] Figure 8A -D shows a method of attaching one suture branch to another suture branch of the suture anchor insertion assembly of Figure 1

[0024] is an example of a kit comprising the suture anchor insertion assembly of Figure 9 Figure 1 DETAILED DESCRIPTION

[0025] In the following description, like parts are marked with the same reference numerals, regardless of whether the example is shown in different drawings. The drawings can not necessarily reflect the proper proportions of the parts, and some features can be shown in a somewhat schematic form for the sake of clarity and conciseness. The disclosure can describe and / or illustrate a feature in one example, and describe and / or illustrate the feature in the same manner or in a similar manner in one or more other examples, and / or describe and / or illustrate a feature in combination with or in place of the feature in one or more other examples.

[0026] In the specification and claims, the terms "about" and "approximately" mean an inherent degree of uncertainty that is expected by one of ordinary skill in the art in making a quantitative comparison, measurement, or other representation of a value, a quantity, or other representation. The terms "about" and "approximately" also mean that a quantitative representation that is nearly the same as a true value does not cause the failure of an intended function of the subject matter at issue. Open terms, such as "comprising," "including," and / or the plural form of each of these terms, include the recited parts and can include additional parts that are not recited, while terms such as "and / or" include one or more of the recited parts and combinations of the recited parts.

[0027] Figure 1 ​​​​​​​An example of a suture anchor insertion assembly 10 of the present disclosure is shown in assembled view. A surgeon can use the suture anchor insertion assembly 10 to insert a suture anchor 100 into bone, for example, during an Achilles tendon repair. As shown in Figure 1 The suture anchor insertion assembly 10 generally includes an inserter 30 having a shaft 20 for engaging the suture anchor 100, as shown in

[0028] Figure 2A An example of an inserter 30 of the present disclosure is shown in perspective view. As shown in Figure 2A The shaft 20 of the inserter 30 includes a distal end 20a configured to engage a suture anchor, a proximal end 20b coupled to a handle 11, and at least one external channel 20c extending along a length of the shaft 20. In examples, the at least one channel 20c includes two opposing channels 20c, or more or less than two channels 20c. The handle 11 generally includes a proximal component 12, a central component 13, and a distal component 14. As described further below, the proximal component 12 houses a needle pre-attached to a suture. The central component 13 rotates relative to the proximal component 12 along a longitudinal axis L of the handle 11. The central component 13 includes a top surface 13a having a groove 13c and a bottom surface 13b having a groove 13d. The grooves 13c, 13d allow the suture to pass through the respective surfaces 13a, 13b of the central component 13 to the proximal component 12. The distal component 14 includes a suture retainer 14d that extends within the channel 20c to retain the suture within the channel 20c prior to advancing the suture anchor into bone.

[0029] Figure 2B The inserter 30 is shown in transparent view showing a needle 37 coupled to an end 36a of a suture 36. The end 36a of the suture 36 is housed within the channel 20c of the shaft 20 and extends through the grooves 13c, 13d of the central component 13 Figure 2A and into a hole 12a in the proximal component 12. As described further below, the central component 13, the proximal component 12, and the end 36a of the suture 36 interact to allow the end 36a of the suture 36 to be retained in the grooves 13c, 13d. Also, the hole 12a of the proximal component 12 retains the needle 37 prior to rotation of the central component 13 relative to the proximal component 12 due to the central component 13 covering the hole 12a.

[0030] Figure 2CThe central component 13 is shown rotated about a 90° angle relative to the proximal component 12, with other angles between about 0° and about 90° also within the scope of the present disclosure. Rotating the central component 13 allows the suture retainer 14d to be removed from the channel 20c of the shaft 20 and exposes the hole 12a in the proximal component 12. Such rotation allows the suture and needle to be removed from the channel 20c, the grooves 13c, 13d, and the hole 12a. Other non-limiting examples of the handle 11 configured to house a needle pre-attached to a suture are shown and described in U.S. Patent No. 9,050,077 to Smith & Nephew, Inc. (Memphis, TN), which is incorporated herein by reference.

[0031] Figure 3A An example of a suture anchor 100 of the present disclosure is shown in a detailed view. The suture anchor 100 includes a proximal end 101 and a distal end 102. A majority of the suture anchor 100 includes a thread 103 in the form of an open helical coil. The open helical coil has a connected series of continuous, regularly spaced multiple turns of thread 103 extending substantially in a helix or spiral form from the proximal end 101 to the distal end 102 of the suture anchor 100, with an aperture 104 defined by the space between the multiple turns of thread 103. The suture anchor 100 defines an interior volume 110 that is in communication with the area outside of the suture anchor 100 through the aperture 104. Additionally, longitudinally extending ribs 106 extend along the interior volume 110 of the suture anchor 100. For the purposes of the present disclosure, two longitudinally extending ribs 106 extend along the interior volume 110. However, the present disclosure can include more or less than two ribs 106. The distal end 102 of the suture anchor 100 also includes a suture bridge 105 extending between the ribs 106 along a portion of the length of the suture anchor 100. The suture bridge 105 includes a proximal end 105a and a distal end 105b. In examples, the ribs 106 extend equally or distally beyond the suture bridge 105. However, in other examples, the distal end 105b of the suture bridge can extend distally beyond the ribs 106. In examples, the distal end 105b of the suture bridge 105 has a concave shape. However, the present disclosure includes other shapes of the distal end 105b of the suture bridge 105, such as bulbous or flat. The suture anchor 100 houses a suture 36 such that the suture 36 extends around the distal end 105b of the suture bridge 105 and the legs 38 of the suture 36 extend through the interior volume 110 of the suture anchor 100. Other non-limiting examples of suture anchors configured for use with the suture anchor insertion assembly 10 of the present disclosure are shown and described in U.S. Patent No. 9,949,820 to Smith & Nephew, Inc. (Memphis, TN), which is incorporated herein by reference.

[0032] Turning now to Figure 3BThe distal end 20a of the shaft 20 of the inserter 30 includes an opening slot 202 defined by a semi-circular fork 204 extending distally. This disclosure contemplates two distally extending forks 204, as well as more or fewer forks 204. A channel 20c extends proximally from the slot 202 on each side of a separating member 210 extending along the distal end 20a of the shaft 20. The distal end 20a of the shaft 20 has a gradually decreasing diameter, such that the distal end 20a of the shaft 20 has a smaller diameter than the rest of the shaft 20. Therefore, an annular neck portion 206 is formed between the distal end 20a of the shaft 20 and the rest of the shaft 20. Furthermore, the circle defined by the fork 204 has a smaller diameter than both the diameter of the distal end 20a of the shaft 20 and the diameter of the rest of the shaft 20. A portion of the channel 20c in the distal end 20a of the shaft 20 has a greater depth than the portions of the channel 20c in the rest of the shaft 20, in order to accommodate the rib 106 of the suture anchor 100. Therefore, a first wall 208 is formed between the portion of the channel 20c extending through the distal end 20a of the shaft 20 and the portion of the channel 20c extending through the rest of the shaft 20. A sidewall 20a' of the distal end 20a of the shaft and a partition member 210 extending from the first wall 208 define the portion of the channel 20c extending through the distal end 20a of the shaft. In this example, the partition member 210 is integrally formed with the sidewall 20a'.

[0033] like Figure 3C As shown, the suture anchor 100 is located on the distal end 20a of the shaft 20, such that the suture bridge 105 is received within the groove 202, the rib 106 is received within the channel 20c, and the proximal end 105b of the suture bridge 105 is near the distal end of the separator 210. A webbed portion 112 may extend between multiple turns of thread 103 in the region of the suture anchor 100 that engages with the fork 204 to increase the stiffness of the distal end 102 of the suture anchor 100 and improve the insertion performance of the suture anchor 100. A suture 36 extends around the distal end 105a of the suture bridge 105 and through the internal volume 110 of the suture anchor 100, such that the legs 38 of the suture 36 protrude from the proximal end 101 of the suture anchor 100 within the channel 20c in the region between the proximal end 101 of the suture anchor 100 and the neck portion 206 of the shaft 20. The suture anchor 100 is also located on the distal end 20a of the shaft 20, so that no gap or void is formed between the thread 103 of the suture anchor 100 and the distal end 20a of the shaft 20.

[0034] Figure 3D A cross-section of a suture anchor 100 disposed on the distal end 20a of shaft 20 is shown. As shown, the rib 106 of the suture anchor 100, the sidewall 20a' of the distal end 20a of shaft 20, and the opposing surfaces of the separating member 210 define a passage 212. Figure 3DIn this example, the partition member 210 extends between the sidewalls 20a' of the distal end 20a of the shaft 20, such that each passage 212 has a substantially equal area. The passage 212 allows the corresponding legs 38 of the suture 36 (not shown) extending around the suture bridge 105 to pass through.

[0035] Figure 4A Another example of a cross-section of a suture anchor 100 disposed on the distal end 20a of the shaft 20 of this disclosure is shown. Figure 4A In this example, one of the ribs 106a of the suture anchor 100, the sidewall 20a', and the surface of the separator 210 define only a single passage 212. In this example, the separator 210 advantageously provides support for the other ribs in the ribs 106b to improve the insertion performance of the suture anchor 100. The passage 212 allows two corresponding legs 38 of the suture 36 extending around the suture bridge 105 to pass through. Figure 3D Compared to other examples, a single passage 212 advantageously allows a larger amount of suture or suture tape to pass through it. Additionally, Figure 4A The example allows the suture or suture tape to be aligned with the suture bridge 105 so that the suture can slide within the passage 212.

[0036] Figure 4B The image shows the part before it is attached to the suture anchor 100. Figure 4A The construction of the distal end 20a of the shaft 20. Specifically, Figure 4B A second wall 214 is shown, formed distal to the first wall 208 by offset placement of the separator 210 relative to the center of the axis 20. The separator 210 extends distally from the second wall 214 to approach the proximal end 105a of the suture bridge 105.

[0037] Figure 5A Another exemplary cross-section is shown of a suture anchor 100 disposed on the distal end 20a of the shaft 20 of this disclosure. Figure 5A In this example, the separator 210 has a "puzzle-like cut" cross-section and extends between the sidewalls 20a', such that each passage 212 has a substantially equal area. In this example, the separator 210 advantageously provides partial support for two of the ribs 106 to improve the insertion performance of the suture anchor 100. The passage 212 allows the passage of corresponding legs 38 of the suture 36 extending around the suture bridge 105. The webbed portion 112 may extend between multiple turns of thread 103 in the region of the anchor 100 that engages with the distal end 20a of the shaft 20 to increase the stiffness of the proximal end 101 of the suture anchor 100 and improve the insertion performance of the suture anchor 100. Figure 3A Compared to the examples, Figure 5A The example allows the suture or suture tape to be aligned with the suture bridge 105 so that the suture can slide within the passage 212.Figure 5B The image shows the connection to the suture anchor 100 before the suture is attached. Figure 5A Construction of the distal end 20a of shaft 20.

[0038] Figure 6A Another exemplary cross-section is shown of a suture anchor 100 disposed on the distal end 20a of the shaft 20 of this disclosure. Figure 6A In this example, the cross-section of the sidewall 20a' has a "dovetail" cut. Separating members 210 extend between the sidewalls 20a' such that each passage 212 has a substantially equal area. In this example, the sidewalls 20a' provide partial support for two ribs in the ribs 106 to advantageously improve the insertion performance of the suture anchor 100. The passages 212 allow the passage of corresponding legs 38 of the suture 36 extending around the suture bridge 105. Webbed portions 112 may extend between multiple turns of thread 103 in the region of the anchor 100 that engages with the distal end 20a of the shaft 20 to increase the stiffness of the proximal end 101 of the suture anchor 100 and improve the insertion performance of the suture anchor 100. For example, as... Figure 6B As shown, the dovetail cut of the sidewall 20a' can have any shape, angle, or construction.

[0039] Now go to Figure 7A In this embodiment, the suture anchor insertion assembly 10 of this disclosure may include an additional suture band or suture 40 pre-assembled to the leg 38 of the suture 36. Pre-assembling the additional suture 40 to the leg 38 of the suture 36 allows the surgeon to use the additional suture 40 while performing repairs using a single suture anchor, with fewer passes of the needle 37 through the tissue. Figure 7A As shown, pre-assembly involves first passing the loop of the suture threader 42 through one or more regions 44 of the leg 38 of the suture 36. Then, an additional suture 40 is passed through the loop of the suture threader 42. Figure 7B As shown, the additional suture 40 is then pulled through the leg 38 region 44 using the suture threader 42. Thus, as... Figure 7C As shown, apart from the branch 38 of the suture 36, the needle 37 can carry one or more additional sutures 40 through the tissue in one pass.

[0040] exist Figure 8A In the alternative example shown in -C, instead of attaching additional sutures to the legs of suture 36, the pre-assembly may instead include attaching a first leg 38a of the suture 36 extending from the suture anchor 100 to a second leg 38b of the suture 36 extending around the suture bridge of the suture anchor 100. In this example, the first leg 38a may pass through two regions 44 of the second leg 38b. Figure 8AIn other instances, the first leg 38a may extend through three or more regions 44 of the second leg 38b. Figure 8B In other instances, the first leg 38a may pass through only one region 44 of the second leg 38b. Figure 8C ).exist Figure 8D In other examples shown, both the additional suture 40 and the first leg 38a can pass through the region 44 of the second leg 38b.

[0041] like Figure 9 As shown, the kit 50 for surgical repair (e.g., Achilles tendon repair) may include at least one suture anchor insertion assembly 10 of this disclosure. In an example, the kit 50 may also include a suture anchor insertion assembly 52, which is different from the suture anchor insertion assembly 10 of this disclosure. In an example, the kit 50 may also include at least a guide 54 and / or a drill 56 for use in surgical repair.

[0042] While preferred embodiments have been specifically shown and described in this disclosure, those skilled in the art will understand that various variations in form and detail may exist without departing from the spirit and scope of this application as defined by the appended claims. The scope of this application is intended to cover these variations. Therefore, the foregoing description of the examples in this application is not intended to limit the full scope conveyed by the appended claims.

Claims

1. A suture anchor insertion assembly comprising: a suture anchor comprising: a body having a proximal end and a distal end, the body defining an interior volume; and at least one rib extending through the interior volume between the proximal and distal ends of the body; an inserter comprising: a handle assembly; and a shaft extending from the handle assembly, an outer surface of the shaft defining at least one channel extending along a length of the shaft, a distal end of the shaft configured for insertion into the interior volume of the suture anchor; and a flexible member comprising at least one leg having an end region coupled to a needle disposed within a proximal component of the handle assembly; wherein the suture anchor is disposed on the distal end of the shaft such that the at least one rib engages the at least one channel and the at least one leg of the flexible member extends through the interior volume of the suture anchor and along the at least one channel, wherein the body of the suture anchor further comprises a suture bridge at the distal end of the body, and wherein the flexible member extends around a distal end of the suture bridge, the distal end of the shaft comprises an open slot defined between prongs extending proximally, and a partition member extending proximally from the open slot, wherein the at least one rib, the partition member, and a sidewall of the distal end of the shaft define at least one passageway for the at least one leg of the flexible member to pass through the interior volume of the suture anchor.

2. The suture anchor insertion assembly of claim 1, wherein the body of the suture anchor further comprises a plurality of turns of thread extending from the proximal end to the distal end of the body, an aperture defined by a space between the plurality of turns of thread.

3. The suture anchor insertion assembly of claim 1, wherein: the suture bridge is positioned within the open slot such that a proximal end of the suture bridge is adjacent to a distal end of the partition member.

4. The suture anchor insertion assembly of claim 3, wherein a cross-section of the partition member has a jigsaw cut.

5. The suture anchor insertion assembly of claim 1, wherein a central component of the handle assembly is configured to rotate relative to the proximal component of the handle assembly to release the end region of the flexible member and the needle from the handle assembly.

6. The suture anchor insertion assembly of claim 1, wherein a central component of the handle assembly is configured to rotate relative to the proximal component of the handle assembly to release the at least one leg of the flexible member from the at least one channel of the shaft.

7. The suture anchor insertion assembly of claim 1, wherein an additional flexible member is attached to the at least one leg of the flexible member.

8. The suture anchor insertion assembly of claim 1, wherein another leg of the flexible member is attached to the at least one leg of the flexible member.

9. A kit for surgical repair comprising: the suture anchor insertion assembly of any one of claims 1-8; Another suture anchor insertion assembly different from the suture anchor insertion assembly; And Drill.

10. The kit of claim 9, wherein the kit further comprises a guide.

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