WO2017172688A1

WO2017172688A1 - Apparatus and method for coupling soft tissue to bone

Info

Publication number: WO2017172688A1
Application number: PCT/US2017/024431
Authority: WO
Inventors: Brett Sanders
Original assignee: Brett Sanders
Priority date: 2016-03-29
Filing date: 2017-03-28
Publication date: 2017-10-05

Abstract

A flexible member is provided for coupling tissue and includes a collapsible self-locking flexible construct which has a through passage therethrough extending from a first end thereof to a second end thereof, and further includes suture tails respectively secured to and extending from first and second ends of the construct. The construct is constructed whereby application of opposed tensile load to the suture tails collapses the construct from a first open profile to a second closed engaging profile for locking suture elements received in the through passage. A flexible suture shuttle is received in and passes through the through passage of the construct with opposite ends of the shuttle exposed beyond the first and second ends of the construct for engaging and shuttling suture elements through the through passage of the construct from first or second ends of the construct.

Description

APPARATUS AND METHOD FOR COUPLING SOFT TISSUE TO BONE

CROSS REFERENCE

[0001] This application claims the benefit of US Provisional Patent Application No. 62/314,499, filed on March 29, 2016, entitled METHOD AND APPARATUS FOR COUPLING SOFT TISSUE TO BONE, the contents of which are incorporated herein by reference in their entirety.

BACKGROUND OF THE INVENTION

[0002] The present disclosure relates to an apparatus and method for coupling soft tissue to bone, such as repairing a torn rotator cuff or other tendons. Arthoscopic procedures are commonly employed to secure soft tissue to bone. The present invention pertains to an apparatus and method for reattaching tendon to bone through the use of transosseous tunnel arthroscopically without the requirement of special hardware fasteners, such as hard suture anchors and hard suture buttons, as required by prior art techniques as disclosed in US Patent Nos. 7,601,165; 7,658,751; 8,118,836; 8,608,777 and 8,672,968. It is accordingly an object of the present teachings to provide an alternative apparatus and method for coupling soft tissue to bone with flexible suture elements without the additional requirement of suture anchoring hardware. SUMMARY

[0003] To overcome the aforementioned deficiencies, a flexible member is provided for coupling tissue which, in its most basic embodiment, is comprised of a collapsible self- locking flexible construct which has a through passage defined therethrough from a first end thereof to a second end thereof, and includes leads or suture tails respectively secured to and extending from the first and second ends of the construct. The collapsible self-locking flexible construct is actuated by applying opposed tensile load to the suture tails, thereby placing the construct under tensile load, which collapses the construct from a first open profile to a second closed engaging profile for locking suture elements received in the through passage of the construct. A flexible suture shuttle is received in and passes through the through passage of the construct with opposite ends of the suture shuttle exposed beyond the first and second ends of the construct for engaging and shuttling suture elements through said through passage from either end.

[0004] The collapsible self-locking construct in one embodiment may be constructed as a braided body. However, constructs of different construction are usable as taught in the prior art. Padding, in the form of tape or various suture configurations, may be secured to one or more of the suture tails at regions where they engage the soft tissue. The flexible suture shuttle in one embodiment may be provided by an endless loop of suture. Other flexible suture shuttle devices may be substituted which also provide a means to temporarily attach other suture elements to either end of the suture shuttle in order to draw them through the through passage of the collapsible self-locking flexible construct in either direction. Soft tissue is coupled to bone with this flexible member by providing a through passage or bore through bone to which the soft tissue or tendon is to be attached. The construct is positioned within the bone bore with the suture tails of the construct respectively exposed from opposite ends of the bone bore. Thereafter free ends of the exposed suture tails may be respectively passed through the tissue to be coupled and on through the through passage of the construct from opposite ends of the construct and out opposite ends of the bone bore with the sequential use of multiple suture shuttles. The free ends of the suture tails which extend from opposite ends of the bone bore are simultaneously pulled, thereby placing the construct under tensile load and collapsing the construct to lock portions of the suture tails, and any additional suture elements, contained in the through passage of the construct to thereby couple the tissue to the bone without the required use of any suture anchor or suture button hardware.

[0005] Positioning the collapsible self-locking construct in the bone bore and passing of the suture tails through the through passage of the collapsible construct is carried out by manipulation or pulling of flexible suture shuttles sequentially positioned in the through passage of the collapsible flexible construct.

[0006] Multiples of this flexible member and technique may be utilized. For example, two adjacent through bone bores may be provided in the bone with two of the afore-described flexible members respectively positioned or received in the bone bores. Tissue is then secured to the bone in the same manner. However, in this instance the free ends of the respective suture tails may be passed through the through passage of an opposite one of the collapsible self-locking flexible constructs. This permits the crossing of suture elements between the respective bone bores in order to provide a more secure coupling of the soft tissue to the bone by the suture elements which are engaging the tissue to be attached. [0007] Hard protective collar elements may be positioned in one or more of the openings of the bone bore or bone bores in order to prevent migration of or cutting of the bone by the suture elements exiting the bone bores. In addition, in order to ensure securement of the coupling, one or more cinch rings may be positioned around the suture elements exiting one or more of the bone bores and the cinch rings are crushed to lock the suture elements in position. Friction in the construct provides fixation in addition to suture knots or other external fixation constructs.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] Other objects and advantages appear hereinafter in the following description and claims. The accompanying drawings show, for the purpose of exemplification, without limiting the scope of the present invention or the appended claims, certain practical embodiments of the present invention wherein:

[0009] FIG. 1 illustrates a plan view of the basic flexible member for coupling tissue;

[0010] FIGS. 2 though 5 are sequential illustrations showing how the basic flexible member of FIG. 1 is applied to affix a rotator cuff tendon to a humeral head using the present flexible member;

[0011] FIG. 6 illustrates an enlarged sagittal view of the upper portion of a humerus with a rotator cuff tendon affixed to the humerus head using the flexible member illustrated in FIGS. 1 through 5; and [0012] FIG. 7 illustrates an enlarged sagittal view of the upper portion of a humerus with a rotator cuff tendon affixed to the humerus using multiples of the present flexible member.

DETAILED DESCRIPTION

[0013] Referring to FIG. 1, the flexible member 10 for coupling tissue includes the collapsible suture self-locking flexible construct 11 which is made of a braided body having a tubular configuration constructed of polyethylene or other suitable fibers and which defines a longitudinally formed through passage 12 having a lead aperture 13 shown at the left side of construct 11 and a trailing aperture 14 at the right side of the construct 1 1. The figure illustrates the left side of the braided body construct 11 being cut away to disclose the interior passage 12 and the suture shuttle 15 consisting of an endless loop of flexible suture passing therethrough, with its opposite ends 16 and 17 completely exposed from opposite ends of construct 11.

[0014] Braided construct 11 is constructed and braided whereby when leading lead or suture tail 18 and trailing lead or suture tail 19 are pulled outwardly and simultaneously in opposite directions, the braided construct 11 constricts about the parallel portions of the suture elements contained within the longitudinal passage 12, since the leading and trailing suture tails 18 and 19 are respectively connected to fibers of opposite twist and extension within the braided construct 11. Accordingly when the suture tails 18 and 19 are stretched under tension in opposite directions outwardly from construct 1 1 , the constriction of braided construct 11 reduces the diameter of the longitudinal passage 12 thus forming a mechanical interface between the exterior surface of the fibers of opposite direction, extension and wind in construct 1 1 whereby the construct 1 1 collapses and the interior surface of the longitudinal passage 12 constricts in tight locking engagement with any suture elements, such as sutures or leads, passing therethrough. Thus, the braided construct 11 functions in a similar manner as the well known toy which is generally referred to as the Chinese finger lock of trap.

[0015] Referring in addition to FIGS. 2 through 5, the right side end of braided construct 11 is secured to a C-shaped steel cinch ring 20 which services two functions. The metal cinch ring 20 first of all has portions 20' in the form of a C-shaped sleeve which serves as a stop that engages the cortex of the bone to prevent bone cut through the bone by sutures or leads passing through construct 11 , and secondly serves as a clamping ring which may be clinched shut as by a pair of plyers to tightly clamp and retain any sutures or leads passing therethough in order to ensure locking capabilities of the construct 11.

[0016] Other locking mechanisms can also be utilized in place of cinch ring 20, such as a screw placed inside an end aperture of construct 1 1, or a knot mechanism. Also, multiple collapsible braided constructs 11 can be used in conjunction with each other and locked together in a "daisy chain", as will be illustrated hereinafter with reference to FIG. 7. Reference will now be made sequentially to FIGS. 2 through 5 in order to illustrate how the flexible member 10 is singularly applied to bone structure in order to secure soft tissue to bone.

[0017] Referring first to FIG. 2, humeral head 30 is schematically illustrated together with torn rotator cuff tendons 31 wherein the tendons of the cuff have been torn away from connection with head 30, the task being the re-attachment of torn rotator cuff tendons 31 to humeral head 30 by utilizing the flexible member 10. [0018] Bone bore 32 is first created through head 30 in any desired conventional manner and an endless transosseous suture loop, which provides first suture shuttle 33, is transosseously passed through bone bore 32 whereby opposite ends 34 and 35 thereof are exposed as illustrated. At this point, suture tail 18, together with end 16 of endless loop suture shuttle 15, are passed through open loop end 35 of suture shuttle 33 as illustrated in FIG. 2.

[0019] Thereafter, end 34 of suture shuttle 33 is pulled firmly in the direction of arrow 36 to thereby pull the opposite end 35 with the suture tail 18 and suture shuttle end 16 entirely through bone bore 32, thereby completely positioning construct 1 1 within bone bore 32 as illustrated in FIG. 3. Suture shuttle end 16, together with suture tail 18 are completely drawn through bone bore 32 and are thereby exposed at the opposite ends of bone bore 32 as illustrated in FIG. 3.

[0020] After passing suture tail 18 and end 16 of suture shuttle 15 through bone bore 32, they are also passed through a puncture passage or passages made through the free end of rotator cuff tendons 31 as is also illustrated in FIG. 3.

[0021] At this point, the split metal cinch ring 20 rests against the cortex of bone head 30 with its sleeve portion 20' received in the opening of bone bore 32, thereby acting as a stop, and additionally preventing any leads or sutures exiting through ring 20 from cutting into the cortex of bone head 30. As an alternative, cinch ring 20 need not be provided with sleeve portion 20' if so desired. At this stage, as further illustrated in FIG. 3, trailing suture tail 19 is passed through the open loop end 16 of suture shuttle 15. Then, end 17 of suture shuttle 15 is grasped and pulled continuously in the direction of arrow 40 to thereby pull suture tail 19 all the way through the central through passage 12 of construct 11 together with the captured end of suture tail 19 and captured suture loop end 35 of suture shuttle 33 to thereby obtain the result and configuration illustrated in FIG. 4 wherein suture tail 19, after being entirely passed through construct 11 , is tightly snugged or pulled as indicated by arrow 41 in FIG. 4 to snugly secure the free end of rotator cuff tendons 31 to head 30 as illustrated,

[0022] At this stage, the free end of suture tail 18 is then passed downwardly through the open loop end 35 of suture shuttle 33 as illustrated in FIG. 4. Thereafter the free end 34 of suture shuttle 33 is then firmly grasped and pulled as indicated by arrow 43 to thereby entirely pull suture shuttle 33 through the central through passage 12 of construct 1 1 together with the captured suture tail 18 and the capture loop end 16 of suture shuttle 15, thereby ultimately obtaining the configuration illustrated in FIG. 5 wherein both suture tails 18 and 19 snugly secure the free end of rotator cuff tendons 31 to head 30. At this point the free ends of suture tails 18 and 19 are simultaneously pulled under tension as indicated by arrows 46 and 47 which not only tightly snugs up the suture tails 18 and 19 to securely secure the free end of cuff tendons 31 to head 30, but in addition, cause the braided body of construct 11 to stretch out and collapse the construct and thereby constrict and automatically cause longitudinal through passage 12 to constrict about suture tails 18 and 19 and suture shuttle 15 (referred to in combination as suture elements) confined therein, whereby they are mechanically retained and locked therein against possible reversal of movement of suture tails 18 and 19, thereby permanently securing the free end of rotator cuff tendons 31 to bone head 30. Suture shuttle 15 may be removed, if desired, before collapsing construct 11. [0023] In order to ensure securement of the arrangement, metal cinch ring 20 is additionally compressed by plyers about suture tails 18 and 19 and the suture lines of suture shuttle 33, if remaining, to lock them against possible movement. The free ends of suture tails 18 and 19, and the free ends of suture shuttle 33, may then be cut or additionally tied and knotted as desired.

[0024] The completed procedure is illustrated in FIG. 6. The collapsible self-locking flexible construct 1 1 of flexible member 12 has been collapsed to its second closed engaging profile for locking the suture elements received in through passage 12 by applying opposed tensile load to the suture tails 18 and 19. Thereafter cinch ring 20 has been crimped or crushed to insure that the suture elements are retained in position. The remaining free ends of suture tails 18 and 19 and suture shuttle 15 may either be cut or tied off. The entire procedure can be readily carried out arthoscopically through a cannula. Note also that one or more of the suture tails 18 and 19 may be applied with padding 45, such as tape or various suture configurations, where they engage the outer surface of cuff tendons 31. In addition, suture leads 18 and 19 have a tape-like cross sectional area to prevent cut-through on the cuff tendons 31.

[0025] As previously mentioned, multiple of the flexible members 10 may be utilized in a "daisy chain" configuration to more securely attach tendons 31 to the bone 30. This is illustrated in FIG. 7, wherein elements of the two flexible members 10 are indicated with the same reference numerals, but with prime marks to distinguish parts of the separate assemblies.

[0026] In this configuration two adjacent through bone bores 32 and 32' are provided in bone 30 and the respective collapsible self-locking constructs are respectively received in these adjacent bone bores 32 with their respective suture tails exposed from opposite ends of the through bone bores 32 and 32'.

[0027] The free ends of the exposed suture tails 18 and 19 and 18' and 19' are respectively passed through tissue in the form of tendons 31 (note that multiple puncture apertures through tendons 31 may be utilized as indicated) and then on through selected ones of the through passages of the two constructs from opposite ends of the constructs. However, in this instance the free ends of the respective suture tails 18 and 19 and 18' and 19' are also passed through the through passage of an opposite one of the collapsible self-locking flexible constructs confined within the respective bone bores 32 and 32'. This permits the crossing of suture elements, here the suture tails 18 and 19 and 18' and 19', between the respective bone bores 32 and 32' in order to provide a more secure coupling of the soft tissue tendons 31 to the bone 30 by the suture element portions which are engaging the tissue tendons 31 to be attached.

[0028] The suture shuttles 15 and 33 may take on configurations other than endless suture loops. Any elongated flexible suture shuttle may be substituted as long as it has means to secure suture elements to opposite ends thereof.

Claims

I claim:

1. A flexible member for coupling tissue comprising:

a collapsible self-locking flexible construct having a through passage defined therethrough from a first end thereof to second end thereof, and including suture tails respectively secured to and extending from said first and second ends, wherein applying opposed tensile load to said suture tails collapses said collapsible self-locking flexible construct from a first open profile to a second closed engaging profile for locking suture elements received in said through passage; and

a flexible suture shuttle received in and passing through said through passage with opposite ends thereof exposed beyond said first and second ends for engaging and shuttling suture elements through said through passage from said first or second end.

2. The flexible member of claim 1 , wherein said self- locking construct is a braided body.

3. The flexible member of claim 1 , including padding secured to one of said suture tails.

4. The flexible member of claim 1 , wherein said flexible suture shuttle is an endless loop of suture.

5. The flexible member of claim 1, wherein said construct is contained within a bone bore with said suture tails and opposite ends of said suture shuttle exposed from opposite ends of said bone bore.

6. A method for coupling tissue to bone with a flexible member including a collapsible self-locking construct having a through passage defined therethrough and suture tails extending respectively from opposite ends thereof for collapsing said construct when said suture tails are simultaneously pulled in opposing directions to apply a tensile load to said construct;

positioning said construct within a through bone bore with said suture tails respectively exposed from opposite ends of said bone bore;

passing free ends of said exposed suture tails respectively through tissue to be coupled to said bone and on through said through passage from opposite ends of said construct and out opposite ends of said bone bore;

simultaneously pulling said suture tail free ends extending respectively from opposite ends of said bone bore thereby placing said construct under tensile load and collapsing said construct to lock portions of said suture tails contained in said through passage to thereby couple said tissue to said bone.

7. The method of claim 6, wherein a cinch ring is positioned around said suture tails and crushed to lock said suture tails in position.

8. The method of claim 7, wherein portions of said cinch ring protrude into one of said ends of said bone bore.

9. The method of claim 6, wherein portions of a ring sleeve are inserted into one of said ends of said bone bore to prevent bone cut by suture elements.

10. The method of claim 6, wherein padding is secured to at least one of said suture tails where tissue is engaged by said suture tails.

1 1. The method of claim 6, wherein the steps of positioning and passing are carried out by pulling flexible suture shuttles positioned in said bone bore and said construct through passage and temporarily connected to suture elements to be positioned or passed.

12. A method for coupling tissue to bone with a pair of flexible members, each member including a collapsible self-locking construct having a through passage defined therethrough and suture tails extending respectively from opposite ends thereof for collapsing said construct when said suture tails are simultaneously pulled in opposing directions to apply a tensile load to said construct;

positioning said constructs respectively within adjacent through bone bores with their respective suture tails exposed from opposite ends of said through bone bores;

passing free ends of said exposed suture tails respectively through tissue to be coupled to said bone and on through selected ones of said through passages from opposite ends of said constructs and out opposite ends of said bone bores;

simultaneously pulling said suture tail free ends of each said construct thereby placing said constructs under tensile load and collapsing said constructs to lock portions of said suture tails contained in said through passages to thereby couple said tissue to said bone.

13. The method of claim 12, wherein cinch rings are positioned around said suture tails and crushed to lock said suture tails in position.

14. The method of claim 13, wherein portions of said cinch rings protrude into ones of said bone bores.

15. The method of claim 13 , wherein portions of a ring sleeve are inserted into one of said ends of said bone bores to prevent bone cut by suture elements.

16. The method of claim 1 1 , wherein padding is secured to at least one of said suture tails where tissue is engaged by said suture tails.

17. The method of claim 1 1 , wherein the steps of positioning and passing are carried out by pulling flexible suture shuttles positioned in said bone bore and said construct through passage and temporarily connected to suture elements to be positioned or passed.