A bone suture assembly including a flexible generally cylindrical sleeve, a plurality of lengths of suture extending through the generally cylindrical sleeve, and at least one sleeve securing thread associated with the generally cylindrical sleeve. A bone suture retaining method including engaging a suture with a bone engaging sleeve, inserting the suture and the bone engaging sleeve engaged thereby into a transosseous tunnel formed into a bone by pulling the bone engaging sleeve into the transosseous tunnel and retaining the suture and the bone engaging sleeve in the transosseous tunnel by virtue of the bone engaging sleeve being unable to fit through an aperture in the bone.

FIELD OF THE INVENTION

The present invention relates to transosseous sutures and methods of use thereof.

BACKGROUND OF THE INVENTION

Various types of transosseous sutures are known in the art.

It is appreciated that the term “suture” as used throughout the description of the present invention refers to any suitable suture and also refers to a transfer wire or pull wire which is used to pull a suture through the bone. Typically, a transfer wire is used with the system and method of the present invention and is formed of Nitinol. Typically, a transfer wire used with the system and method of the present invention is folded over to form a loop at one end.

SUMMARY OF THE INVENTION

The present invention seeks to provide improved transosseous sutures.

There is thus provided in accordance with a preferred embodiment of the present invention a bone suture assembly including a flexible generally cylindrical sleeve, a plurality of lengths of suture extending through the generally cylindrical sleeve, and at least one sleeve securing thread associated with the generally cylindrical sleeve.

Preferably, the generally cylindrical sleeve is deformable. Additionally, the bone suture assembly includes at least one thread associated with the deformable cylindrical sleeve for selectively deforming the generally cylindrical sleeve. Additionally, the at least one thread for selective deforming includes a thread which is looped through apertures at opposite ends of the generally cylindrical sleeve and when pulled, draws the opposite ends towards each other, thereby deforming the generally cylindrical sleeve.

Preferably, the generally cylindrical sleeve is bendable but not deformable. Additionally or alternatively, the generally cylindrical sleeve is formed at one end thereof with a flange. Alternatively or additionally, the at least one sleeve securing thread includes at least one thread attached to the generally cylindrical sleeve at an end thereof. Additionally or alternatively, the at least one sleeve securing thread includes at least one thread looped through an aperture formed in the generally cylindrical sleeve at an end thereof. Also additionally or alternatively, the at least one sleeve securing thread includes at least one thread stitched along the generally cylindrical sleeve and having free ends extending beyond ends of the generally cylindrical sleeve.

In accordance with a preferred embodiment of the present invention the bone suture assembly also includes a flexible second outer sleeve affixed to and at least partially enclosing the flexible generally cylindrical sleeve. Additionally the flexible second outer sleeve is not deformable and includes a cylindrical portion and a conical portion, the cylindrical portion having a diameter approximately matching that of the exterior of the generally cylindrical sleeve and the conical portion extending outwardly of the generally cylindrical sleeve. Alternatively, the flexible second outer sleeve is generally cylindrical, is generally shorter than the generally cylindrical flexible sleeve and is deformable.

In accordance with a preferred embodiment the flexible generally cylindrical sleeve is a generally cylindrical braided sleeve. Additionally, the generally cylindrical sleeve may be pre-stressed to cause a torus shaped portion to be formed adjacent one end of the generally cylindrical braided sleeve and the pre-stressed generally cylindrical braided sleeve is stretchable to a generally cylindrical shape.

There is also provided in accordance with another preferred embodiment of the present invention a bone suture retaining method including engaging a suture with a bone engaging sleeve, inserting the suture and the bone engaging sleeve engaged thereby into a transosseous tunnel formed into a bone by pulling the bone engaging sleeve into the transosseous tunnel and retaining the suture and the bone engaging sleeve in the transosseous tunnel by virtue of the bone engaging sleeve being unable to fit through an aperture in the bone.

Preferably, the aperture in the bone is formed in bone cortex. Alternatively, the aperture in the bone is formed in bone medulla.

Preferably, the pulling is effected by pulling a flexible elongate element attached to the sleeve. Additionally or alternatively, the method includes deforming the bone engaging sleeve within the transosseous tunnel by pulling an elongated element attached to the bone engaging sleeve and thereby further engaging the bone engaging sleeve in the transosseous tunnel.

In accordance with a preferred embodiment of the present invention the bone suture retaining method includes deforming the bone engaging sleeve together with a flexible and deformable outer sleeve affixed thereto. Alternatively, the method includes expanding a flexible non-deformable conical outer sleeve affixed to the bone engaging sleeve following entry of the bone engaging sleeve into the transosseous tunnel.

In accordance with a preferred embodiment of the present invention the bone engaging sleeve is braided and the method includes pre-stressing the bone engaging sleeve to form a torus shaped portion adjacent one end thereof, stretching the bone engaging sleeve prior to the inserting and subsequent to the inserting and releasing the bone engaging sleeve thereby allowing re-expansion of the torus shaped portion.

There is thus further provided in accordance with another preferred embodiment of the present invention a suture including a threadable padding and at least one suture engaged with an outside surface of the padding, the padding having a shape to enable the suture to be threadable through an interior of the padding.

There is yet further provided in accordance with yet another preferred embodiment of the present invention, a suture including a threadable padding, a threader passed through the padding, the threader having a loop thereon at one end of the threader and a threader passed through the padding, the threader having a loop thereon at one end of the threader and at least one suture to be engaged through an outside surface of the padding and to be threaded through the loop, the padding having a shape to enable the loop to be threaded therethrough.

It will be appreciated that for simplicity and clarity of illustration, segments shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the segments may be exaggerated relative to other segments for clarity. Further, where considered appropriate, reference numerals may be repeated among the various figures to indicate corresponding or analogous segments.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

Reference is now made toFIGS. 1A & 1B, which are simplified respective pictorial and sectional illustrations of a transosseous suture assembly constructed and operative in accordance with a preferred embodiment of the present invention in a first operative orientation. As seen inFIGS. 1A & 1B, the transosseous suture assembly preferably includes a flexible and deformable sleeve100, preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton. Flexible and deformable sleeve100includes a generally circularly cylindrical main portion102having a first outer diameter of, typically slightly less than 3.2 mm in the first operative orientation where sleeve100is in a relaxed, extended state, and an outwardly extending flange portion104, having a second outer diameter greater than the first outer diameter of main portion102. A bore106extends from a first end108of the flexible and deformable sleeve100to a second end110of the flexible and deformable sleeve100at flange portion104.

A first flexible thread112is attached to flexible and deformable sleeve100adjacent first end108thereof and has a free end113extending beyond first end108and a second flexible thread114is attached to flexible and deformable sleeve100adjacent second end110thereof and has a free end115extending beyond second end110. A sleeve shortening thread120is preferably threaded through an aperture126at one end122of the flexible and deformable sleeve100adjacent first end108thereof and extends along most of the length of the sleeve to and through an aperture124adjacent the second end110of the flexible and deformable sleeve100and is looped back and fastened to first end125of the sleeve shortening thread120near aperture126and has a free end130extending beyond end108.

A plurality of lengths of suture, typically three in number, here collectively designated by reference numeral140, extend through flexible and deformable sleeve100and beyond both ends108and110thereof.

Reference is now made toFIGS. 2A & 2B, which are simplified respective pictorial and sectional illustrations of the transosseous suture assembly ofFIGS. 1A & 1Bin a second operative orientation, which results from pulling on the free end130of sleeve shortening thread120while holding flexible and deformable sleeve100. As seen inFIGS. 2A and 2Band comparing them withFIGS. 1A & 1B, the overall length of the loop of sleeve shortening thread120, which extends through apertures124and126is shortened, thus longitudinally shortening and deforming the flexible and deformable sleeve100, typically as shown. This effectively widens the diameter of the flexible and deformable sleeve100.

Reference is now made toFIGS. 3A & 3B, which are simplified respective pictorial and sectional illustrations of a transosseous suture assembly constructed and operative in accordance with another preferred embodiment of the present invention in a first operative orientation. As seen inFIGS. 3A & 3B, the transosseous suture assembly preferably includes a flexible and deformable sleeve300, preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton. Flexible and deformable sleeve300includes a generally circularly cylindrical main portion302having a first outer diameter of, typically slightly less than 3.2 mm in a relaxed, extended state, and an outwardly extending flange portion304, having a second outer diameter greater than the first outer diameter of main portion302. A bore306extends from a first end308of the flexible and deformable sleeve300to a second end310of the sleeve at flange portion304.

A first flexible thread311is attached to flexible and deformable sleeve300by being looped through an aperture312formed therein adjacent first end308thereof and has two free ends313extending beyond first end308and a second flexible thread314is attached to flexible and deformable sleeve300adjacent second end310thereof and has a free end315extending beyond second end310. A sleeve shortening thread320is preferably threaded through an aperture326at one end322of the flexible and deformable sleeve300adjacent first end308thereof and extends along most of the length of the sleeve to and through an aperture324adjacent the second end310of the flexible and deformable sleeve300and is looped back and fastened to first end325of the sleeve shortening thread320near aperture326and has a free end330extending beyond end308.

A plurality of lengths of suture, typically three in number, here collectively designated by reference numeral340, extend through flexible and deformable sleeve300and beyond both ends308and310thereof.

Reference is now made toFIGS. 4A & 4B, which are simplified respective pictorial and sectional illustrations of the transosseous suture assembly ofFIGS. 3A & 3Bin a second operative orientation, which results from pulling on the free end330of sleeve shortening thread320while holding flexible and deformable sleeve300. As seen inFIGS. 4A and 4Band comparing them withFIGS. 3A & 3B, the overall length of the loop of sleeve shortening thread320, which extends through apertures324and326is shortened, thus longitudinally shortening and deforming the flexible and deformable sleeve300, typically as shown. This effectively widens the flexible and deformable sleeve300and increases the diameter thereof to a second outer diameter greater than the first outer diameter of the first operative orientation shown inFIGS. 3A & 3B.

Reference is now made toFIGS. 5A & 5B, which are simplified respective pictorial and sectional illustrations of a transosseous suture assembly constructed and operative in accordance with yet another preferred embodiment of the present invention in a first operative orientation. As seen inFIGS. 5A & 5B, the transosseous suture assembly preferably includes a flexible and deformable sleeve500, preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton. Flexible and deformable sleeve500includes a generally circularly cylindrical main portion502having a first outer diameter of, typically slightly less than 3.2 mm in a relaxed, extended state, and an outwardly extending flange portion504, having a second outer diameter greater than the first outer diameter of main portion502. A bore506extends from a first end508of the flexible and deformable sleeve500to a second end510of the sleeve at flange portion504.

A first flexible thread512is attached to flexible and deformable sleeve500adjacent first end508thereof and has a free end513extending beyond first end508and a second flexible thread514is attached to flexible and deformable sleeve500adjacent second end510thereof and has a free end515extending beyond second end510. A sleeve shortening thread520is preferably threaded through an aperture526at one end522of the flexible and deformable sleeve500adjacent first end508thereof and extends along most of the length of the sleeve to and through an aperture524adjacent the second end510of the flexible and deformable sleeve500and is looped back and fastened to first end525of the sleeve shortening thread520near aperture526and has a free end530extending beyond end508.

A plurality of lengths of suture, typically three in number, here collectively designated by reference numeral540, extend through flexible and deformable sleeve500and beyond both ends508and510thereof. Attached near first end508of flexible and deformable sleeve500is an outer second sleeve550whose diameter is approximately equal to that of the exterior of the generally circularly cylindrical main portion502so that flexible and deformable sleeve500may be inserted into outer second sleeve550and become engaged within. Outer second sleeve550extends typically two-thirds to three-quarters the length of flexible and deformable sleeve500to end560, is preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton and is flexible and deformable. First flexible thread512, in addition to being attached to flexible and deformable sleeve500, is also attached to outer second sleeve550adjacent first end508of flexible and deformable sleeve500.

Reference is now made toFIGS. 6A & 6B, which are simplified respective pictorial and sectional illustrations of the transosseous suture assembly ofFIGS. 5A & 5Bin a second operative orientation, which results from pulling on the free end530of sleeve shortening thread520while holding flexible and deformable sleeve500. As seen inFIGS. 6A and 6Band comparing them withFIGS. 5A & 5B, the overall length of the loop of sleeve shortening thread520, which extends through apertures524and526is shortened, thus longitudinally shortening and deforming the flexible and deformable sleeve500, typically as shown, with both the flexible and deformable sleeve500and the outer second sleeve550contracting between the end560of the outer second sleeve550and the first end508of the flexible and deformable sleeve. This effectively increases the diameter of the combined flexible and deformable sleeve500and the outer second sleeve550between the end560of the outer second sleeve550and the first end508of the flexible and deformable sleeve500. Inclusion of the outer second sleeve550significantly increases the total amount of material in the contracted region between the end560of the outer second sleeve550and the first end508of the flexible and deformable sleeve, as compared to only the flexible and deformable sleeve500, and thus results in the dual sleeve having a greater total diameter.

Reference is now made toFIGS. 7A & 7B, which are simplified respective pictorial and sectional illustrations of a transosseous suture assembly constructed and operative in accordance with still another preferred embodiment of the present. As seen inFIGS. 7A & 7B, the transosseous suture assembly preferably includes a flexible sleeve700, preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton. Flexible sleeve700including a generally circularly cylindrical main portion702having a first outer diameter of, typically slightly less than 3.2 mm, and an outwardly extending flange portion704, having a second outer diameter greater than the first outer diameter of main portion702. A bore706extends from a first end708of the flexible sleeve700to a second end710of the sleeve.

A flexible thread712is loosely stitched along the length of flexible sleeve700from a location adjacent first end708thereof and has a free end713extending beyond first end708to a location adjacent second end710thereof and has a free end715extending beyond second end710. Flexible thread712, in this embodiment, is an alternative to having first and second threads attached to flexible sleeve700(seeFIG. 13Dbelow); flexible sleeve700may be manufactured with flexible thread712imbedded, thus obviating the need for manual affixing or looping of threads into flexible sleeve700. A plurality of lengths of suture, typically three in number, here collectively designated by reference numeral740, extend through flexible sleeve700and beyond both ends708and710thereof.

Reference is now made toFIGS. 8A & 8B, which are simplified respective pictorial and sectional illustrations of a transosseous suture assembly constructed and operative in accordance with a further preferred embodiment of the present. As seen inFIGS. 8A & 8B, the transosseous suture assembly preferably includes a flexible sleeve800, preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton. Flexible sleeve800including a generally circularly cylindrical main portion802having a first outer diameter of, typically slightly less than 3.2 mm, and an outwardly extending flange portion804, having a second outer diameter greater than the first outer diameter of main portion802. A bore806extends from a first end808of the flexible sleeve800to a second end810of the sleeve at flange portion804.

A first flexible thread812is attached to flexible sleeve800adjacent first end808thereof and has a free end813extending beyond first end808and a second flexible thread814is attached to flexible sleeve800adjacent second end810thereof and has a free end815extending beyond second end810. Optionally as shown, a tightening thread820is threaded through an aperture826at one end822of the flexible sleeve800adjacent first end808thereof and extends along most of the length of the sleeve to and through an aperture824adjacent the second end810of the flexible sleeve800and is looped back and fastened to first end825of the tightening thread820near aperture826and has a free end830extending beyond end808.

A plurality of lengths of suture, typically three in number, here collectively designated by reference numeral840, extend through flexible sleeve800and beyond both ends808and810thereof. Attached near first end808of flexible sleeve800is a flared outer second sleeve850, having a cylindrical portion and a conical portion whose cylindrical portion has a diameter approximately matching that of the exterior of the generally circularly cylindrical main portion802near the first end808and whose diameter increases toward the second end810of the flexible sleeve800. Flared outer second sleeve850has a horn-like shape, open at end860, and is flexible.

Reference is now made toFIGS. 9A & 9B, which are simplified respective pictorial and sectional illustrations of a transosseous suture assembly constructed and operative in accordance with a yet further preferred embodiment of the present. As seen inFIGS. 9A & 9B, the transosseous suture assembly preferably includes a flexible sleeve900, preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton. Flexible and deformable sleeve900includes a generally circularly cylindrical main portion902having a first outer diameter of, typically slightly less than 3.2 mm, and an outwardly extending flange portion904, having a second outer diameter greater than the first outer diameter of main portion902. A bore906extends from a first end908of the flexible sleeve900to a second end910of the sleeve.

A first flexible thread912is attached to flexible sleeve900adjacent first end908thereof and has a free end913extending beyond first end908and a second flexible thread914is attached to flexible sleeve900adjacent second end910thereof and has a free end915extending beyond second end910. A plurality of lengths of suture, typically three in number, here collectively designated by reference numeral940, extend through flexible sleeve900and beyond both ends908and910thereof.

Reference is now made toFIGS. 10A & 10B, which are simplified respective pictorial and sectional illustrations of a transosseous suture assembly constructed and operative in accordance with a still further preferred embodiment of the present invention in a first operative orientation. As seen inFIGS. 10A & 10B, the transosseous suture assembly preferably includes a flexible and deformable braided sleeve1000, preferably formed of a polyester mesh such as polyester peek or nylon, or nitinol or cotton. Flexible and deformable braided sleeve1000including a generally circularly cylindrical main portion1002having a first outer diameter of, typically slightly less than 3.2 mm in a relaxed, extended state, and an outwardly extending flange portion1004, having a second outer diameter greater than the first outer diameter of main portion1002. A bore1006extends from a first end1008of the flexible and deformable braided sleeve1000to a second end1010of the sleeve at flange portion1004.

A first flexible thread1011is attached to flexible and deformable braided sleeve1000by being looped through an aperture1012formed therein adjacent first end1008thereof and has two free ends1013extending beyond first end1008and a second flexible thread1014is attached to flexible and deformable braided sleeve1000adjacent second end1010thereof and has a free end1015extending beyond second end1010. In an alternative embodiment, first flexible thread1011is affixed to flexible and deformable braided sleeve1000at aperture1012adjacent first end1008and has a free end1013extending beyond first end1008. A tightening thread1020is preferably threaded through an aperture1026at one end1022of the flexible and deformable braided sleeve1000adjacent first end1008thereof and extends along most of the length of the sleeve to and through an aperture1024adjacent the second end1000of the flexible and deformable braided sleeve1000and is looped back and fastened to first end1025of the tightening thread1020near aperture1026and has a free end1030extending beyond end1008.

A plurality of lengths of suture, typically three in number, here collectively designated by reference numeral1040, extend through flexible and deformable braided sleeve1000and beyond both ends1008and1010thereof. Adjacent flange1004at second end1010of the flexible and deformable braided sleeve1000, the flexible and deformable braided sleeve1000has been pre-stressed or pre-formed and, as shown, a torus shaped portion1050is made in the flexible and deformable braided sleeve1000with an outer diameter typically about 6 mm. As shown inFIGS. 10A & 10B, the pre-stressed flexible and deformable braided sleeve1000is in a relaxed state. In an alternative embodiment, flexible and deformable braided sleeve1000is not pre-stressed and is thus generally circularly cylindrical with no torus shaped portion1050pre-formed.

Reference is now made toFIGS. 11A & 11B, which are simplified respective pictorial and sectional illustrations of the transosseous suture assembly ofFIGS. 10A & 10Bin a second operative orientation, which results from pulling on the free ends1013of first flexible thread1011while holding second flexible thread1014. As seen inFIGS. 11A and 11Band comparing them withFIGS. 10A & 10B, the overall length of the flexible and deformable braided sleeve1000is increased, thus longitudinally stretching the flexible and deformable braided sleeve1000, specifically flattening the pre-formed torus shape1050, typically as shown. This effectively narrows the diameter of the flexible and deformable braided sleeve1000to a near uniform diameter, typically slightly less than 3.2 mm.

It is understood that, in an alternative embodiment with a non pre-stressed flexible and deformable braided sleeve1000, the flexible and deformable braided sleeve1000will appear as is shown inFIGS. 11A & 11B, when in a relaxed state.

Reference is now made toFIGS. 12A, 12B, 12C, 12D & 12E, which are together a simplified illustration of some preliminary stages of the insertion of a transosseous suture assembly of any of the embodiments illustrated inFIGS. 1A-11B;

Referring specifically toFIG. 12A, which is a simplified illustration of a first stage of the insertion of a transosseous suture assembly into a bone, it is seen that a first looped transfer wire1200has been inserted into a side bore1202made in a bone and has been pulled through the bone until it exits a top bore1204made in the bone. Loop1206of first looped transfer wire1200extends outside top bore1204and a pair of loose ends1208of first looped transfer wire1200extend outside side bore1202. It is noted (shown below inFIGS. 13A-13G) that top bore1204is generally narrower than side bore1202and intersects side bore1202within the osseous portion of the bone at nearly a right angle.

Referring now specifically toFIG. 12B, which is a simplified illustration of a second stage of the insertion of a transosseous suture assembly into a bone, it is seen that a second looped transfer wire1210has been inserted into loop1206of first looped transfer wire1200extending outside top bore1204in bone. Loop1216of second looped transfer wire1210extends through loop1206of first looped transfer wire1200while a pair of loose ends1218of second looped transfer wire1210extend outside other side of loop1206of first looped transfer wire1200. Following this second stage of the insertion of a transosseous suture assembly into a bone, the first looped transfer wire1200is pulled through the bone from the top bore1204through the side bore1202, pulling the second looped transfer wire1210through the bone with it.

Reference is now made toFIG. 12C, which is a simplified illustration of a third stage of the insertion of a transosseous suture assembly into a bone. In this stage it is seen that the second looped transfer wire1210has been pulled through the top bore1204(as described above in reference toFIG. 12B) and out the side bore1202; loop1216now extends outside side bore1202with the pair of loose ends1218extending out of top bore1204resulting in the second looped transfer wire1210being in the reverse position of the first looped transfer wire1200, as seen inFIG. 12A.

Referring now specifically toFIG. 12D, which is a simplified illustration of a fourth stage of the insertion of a transosseous suture assembly into a bone, it is seen that a transosseous suture1240has been inserted through the loop1216of the second looped transfer wire1210, which extends outside side bore1202in bone. Transosseous suture1240comprises a generally cylindrical portion1242with a plurality of sutures1244, typically three, threaded through a bore1246formed in generally cylindrical portion1242and extending from first end1248to second end1250of generally cylindrical portion1242of transosseous suture1240, and an outwardly extending flange portion1251. It is understood that, when referring here to the transosseous suture1240, reference is being made to any one of the above defined flexible sleeve embodiments of the current invention. Sutures1244have free ends1252at first end1248, shown extending through loop1216of the second looped transfer wire1210, and free ends1254extending from second end1250of the generally cylindrical portion1242of the transosseous suture1240. Following this fourth stage of the insertion of a transosseous suture assembly into a bone, the second looped transfer wire1210is pulled through the bone from the side bore1202through the top bore1204, pulling the transosseous suture1240into the side bore1202in the bone. Sutures1262and1264, now extending from top bore1204and side bore1202, respectively, are affixed and/or looped through apertures in transosseous suture1240.

Reference is now made toFIG. 12E, which is a simplified pictorial illustration of a fifth stage in the insertion of a transosseous suture assembly into a bone. It is seen that transosseous suture1240has become engaged within side bore1202in the bone and sutures1244have been pulled through top bore1204in bone. In this stage, the free ends1252of the transosseous suture1240extend outside the top bore1204, while the free ends1254at the opposite end of the transosseous suture1240extend outside the side bore1202in the bone. Transosseous suture1240has become engaged in side bore1204and cannot progress into top bore1204because top bore1204is narrow and because nearly right angle formed at intersection of top bore1204and side bore1202both inhibit passage, as described above in reference toFIG. 12A, and because of outwardly extending flange portion1251which inhibits complete passage of the transosseous suture1240into the side bore1204, being generally wider than the diameter of the side bore1204. It is understood and described below that, some embodiments may become more tightly engaged in bone by pulling on locking suture1280, when locking suture1280is present.

Reference is now made toFIGS. 13A, 13B, 13C & 13D, 13E, 13F & 13G, which are simplified sectional illustrations of the penultimate stage of the insertion of the transosseous suture assembly, as described above in relation toFIG. 12E, of the various embodiments illustrated inFIGS. 1A-2B,FIGS. 3A-4B,FIGS. 5A-6B,FIGS. 7A& B,FIGS. 8A& B,FIGS. 9A& B andFIGS. 10A-11B, respectively. Each ofFIGS. 13A, 13B, 13C, 13D, 13E.13F &13G demonstrate the effect on the sleeve of pulling a suture attached to the sleeve from the top bore, engaging the sleeve within the side bore of the bone. It is understood that each ofFIGS. 13A-13Gare respective sectional illustrations ofFIG. 12E, one illustration per preferred embodiment of the present invention, as described and shown in connection withFIGS. 1A-11B

Reference is now made toFIG. 13A, which is a simplified sectional illustration of the penultimate stage of the insertion of the transosseous suture assembly of the embodiment illustrated inFIGS. 1A-2B. As shown, the flexible and deformable sleeve100, described in relation toFIGS. 1A-2B, becomes tightly engaged in the side bore1302of the bone after first being pulled into the side bore1302when first flexible thread112is pulled from outside top bore1304, then having sleeve shortening thread120pulled from outside top bore1304. Pulling sleeve shortening thread120causes distension of the middle section of the flexible and deformable sleeve100widening it and further engaging it in the bone. A plurality of lengths of suture140are seen to extend from both the side bore1302and the top bore1304.

Reference is now made toFIG. 13B, which is a simplified sectional illustration of the penultimate stage of the insertion of the transosseous suture assembly of the embodiment illustrated inFIGS. 3A-4B. As shown, the flexible and deformable sleeve300, described in relation toFIGS. 3A-4B, becomes tightly engaged in the side bore1302of the bone after first being pulled into the side bore1302when first flexible thread311is pulled from outside top bore1304, then having tightening suture320pulled from outside top bore1304. Pulling tightening suture320causes distension of the middle section of the flexible and deformable sleeve300widening it and further engaging it in the bone. Optionally, first flexible thread311may be pulled from top bore of bone by one of free ends313so that it is removed from flexible and deformable sleeve300, once flexible and deformable sleeve300is fully engaged in side bore of bone. A plurality of lengths of suture340are seen to extend from both the side bore1302and the top bore1304.

Reference is now made toFIG. 13C, which is a simplified sectional illustration of the penultimate stage of the insertion of the transosseous suture assembly of the embodiment illustrated inFIGS. 5A-6B. As shown, the flexible and deformable sleeve500, described in relation toFIGS. 5A-6Band having an outer second sleeve550, becomes tightly engaged in the side bore1302of the bone after first being pulled into the side bore1302when suture512is pulled from outside top bore1304, then having sleeve shortening thread520pulled from outside top bore1304. Pulling sleeve shortening thread520causes distension of the middle section of both the flexible and deformable sleeve500and the outer second sleeve550, widening them and further engaging the flexible and deformable sleeve500in the bone. A plurality of lengths of suture540are seen to extend from both the side bore1302and the top bore1304.

Reference is now made toFIG. 13D, which is a simplified sectional illustration of the penultimate stage of the insertion of the transosseous suture assembly of the embodiment illustrated inFIGS. 7A & 7B. As shown, the flexible sleeve700, described in relation toFIGS. 7A & 7B, becomes engaged in the side bore1302of the bone after being pulled into the side bore1302when flexible thread712is pulled from outside top bore1304. In other embodiments, a suture either fixed to, or looped through an aperture in sleeve is used to pull the sleeve into the bone. A plurality of lengths of suture740are seen to extend from both the side bore1302and the top bore1304.

Reference is now made toFIG. 13E, which is a simplified sectional illustration of the penultimate stage of the insertion of the transosseous suture assembly of the embodiment illustrated inFIGS. 8A & 8B. As shown, the flexible sleeve800, described in relation toFIGS. 8A & 8B, becomes tightly engaged in the side bore1302of the bone after being pulled into the side bore1302when first flexible thread812is pulled from outside top bore1304. When flexible sleeve800is pulled into bone, the flared outer second sleeve850flexes and its outer diameter is decreased as it passes into the side bore1302. Once inside the osseous portion of the bone, the flared outer second sleeve recovers to near the original shape and, thus widened, causes tighter engagement in the bone. When optional tightening thread820is attached to flexible and deformable sleeve800, it may be used to further tighten the engagement of the flexible sleeve in the bone by tying it together outside bone, similar to what is shown inFIG. 14below. A plurality of lengths of suture840are seen to extend from both the side bore1302and the top bore1304.

Reference is now made toFIG. 13F, which is a simplified sectional illustration of the penultimate stage of the insertion of the transosseous suture assembly of the embodiment illustrated inFIGS. 9A & 9B. As shown, the flexible sleeve900, described in relation toFIGS. 9A & 9B, becomes engaged in the side bore1302of the bone after being pulled into the side bore1302when first flexible thread912is pulled from outside top bore1304. A plurality of lengths of suture940are seen to extend from both the side bore1302and the top bore1304.

Reference is now made toFIG. 13G, which is a simplified sectional illustration of the penultimate stage of the insertion of the transosseous suture assembly of the embodiment illustrated inFIGS. 10A-11B. As shown, the flexible and deformable braided sleeve1000, described in relation toFIGS. 10A-11B, becomes tightly engaged in the side bore1302of the bone after first being stretched then pulled into the side bore1302when first flexible thread1011is pulled from outside top bore1304. The stretching causes the torus shaped portion1050of flexible and deformable braided sleeve1000to compress and the flexible and deformable braided sleeve1000to approximate a generally circular cylindrical shape, allowing passage of the flexible and deformable braided sleeve1000into the side bore1302of the bone. Upon entry into the osseous portion of the bone, and once tension caused by pulling on the first flexible thread1011is relaxed, the flexible and deformable braided sleeve1000relaxes and the pre-formed torus shaped portion1050reasserts itself, tightly engaging the flexible and deformable braided sleeve1000in the bone, as shown. Optionally, tightening thread1020, when present, may tied together outside bone thus further tightening engagement of the transosseous suture in the bone. Optionally, first flexible thread1011may be pulled from top bore of bone by one of free ends1013so that it is removed from flexible and deformable sleeve1000, once flexible and deformable braided sleeve1000is fully engaged in side bore of bone. A plurality of lengths of suture1040are seen to extend from both the side bore1302and the top bore1304.

Alternatively, when the flexible and deformable braided sleeve1000has not been pre-stressed or pre-formed and flexible and deformable braided sleeve1000is generally circularly cylindrical in a relaxed state, the flexible and deformable braided sleeve1000becomes tightly engaged in the side bore1302of the bone after first being pulled into the side bore1302when first flexible thread1011is pulled from outside top bore1304, then having tightening thread1020pulled from outside top bore1304. Pulling tightening thread1020causes distension of the middle section of the flexible and deformable braided sleeve1000widening it and further engaging it in the bone. Optionally, first flexible thread1011may be pulled from top bore of bone by one of free ends1013so that it is removed from flexible and deformable sleeve1000, once flexible and deformable sleeve1000is fully engaged in side bore of bone.

Reference is now made toFIG. 14, which is a simplified illustration of a final stage of the insertion of the transosseous suture assembly of each of the various embodiments illustrated inFIGS. 1A-11B. As shown, two loose ends1413and1415of sutures1412and1414attached to a sleeve now loosely engaged within the side bore1402in the bone, one extending through the top bore1404and one extending through the side bore1402respectively, are tied and knotted together tightly outside the bone, forming a knot1480. This further engages the transosseous suture assembly within the bone. This final step is typically done for all embodiments of the current invention described above inFIGS. 1A-11B.

Applicants have realized that although the transosseous approach efficiently fixates a suture in the bone, padding the inner walls of the tunnel would be advantageous in protecting the bone.

Applicants have realized that passing a transosseous suture through a protective sleeve may protect the bone and may also assist in fixating the suture within the transosseous tunnel, preventing its movement and subsequent displacement from within the tunnel during deployment and thereafter.

Reference is now made toFIG. 15A, which illustrates a padded transosseous suture (PTS)1540, constructed and operative in accordance with a preferred embodiment of the present invention, and shown in situ after PTS1540has been implanted in bone1530. PTS1540may comprise a suture1541, seen in the side view ofFIG. 15A, and a padding1546. Suture1541may be divided, generally into three segments, a tunnel segment1542, a padded segment1544and an extending section1552, where padding1546around a portion of padded segment1544. Tunnel segment1542may connect to a rear section1548of padding1546and may extend, when in situ, from the back of first tunnel1526up through tunnel1528and through tendon1529. It may continue on top of tendon1529to padding segment1544.

When in situ, padding1546may be folded inside of first tunnel1526. Padding segment1544may extend into first tunnel1526where it may pass through padding1546and thus, may also be folded. It may extend back out of tunnel1526, becoming extending segment, labeled1552, which may also be used to tie off suture1541.

Reference is now briefly made toFIG. 15Bwhich is an isometric solid drawing of PTS1540after implantation. Suture1541can be seen going through tendon1529to bring it in contact with the bone1530, with extending segment1552extending from first tunnel1526. As shown hereinbelow inFIG. 16A, suture1541may be threaded through or otherwise connected to padding1546, thereby to provide two of each suture segment. Thus, the two extending segments1552may be tied together in a knot at the opening1527of first tunnel1526once padding1546is in place. This will prevent suture1541from moving in the tunnels and will keep tendon1529in place.

Applicants have realized that an unpressed fold in a fabric generally is an area where the fabric is thick. Thus, the area of the fold, labeled1554, may be an area of greater friction and may serve to hold PTS1540in place in first tunnel1526. Thus, padding1546may be sized such that, at fold1554, padding1546may push against first tunnel1526. Moreover, since second tunnel1528may be at an angle, such as between 40 and 170 degrees, with first tunnel1526, padding1546may not move into second tunnel1528.

It will be appreciated that padding1546may both hold PTS1540in situ and may pad padded segment1544to keep it from rubbing against the inner surface of first tunnel1526. Moreover, due to the connection of tunnel segment1542at the back of fold1554, tunnel segment1542may be held largely in the middle of second tunnel1528and thus, may also not rub against the inner surface of second tunnel1528.

It will also be appreciated that PTS1540may be self-locking inside tunnel1528due to the friction against fold1554. Accordingly, PTS1540will generally not move from its final position.

PTS1540may be placed into tunnels1526and1528by pulling tunnel segment1542(which may already be in the tunnels, as described in more detail hereinbelow) from the entrance of first tunnel1526towards second tunnel1528. Since tunnel segment1542may be connected to rear segment1548, it may force padding1546to fold in order to enter first tunnel1528. Pulling tunnel segment1542further may pull padding1546into first tunnel1528.

Reference is now made toFIGS. 16A and 16B, which illustrates PTS1540before it is implanted in the bone and shows suture1541passing through padding1546, thereby to connect suture1541to padding1546. As a result of passing through or otherwise being connected to padding1546, suture1541may have two strings, labeled1541A and1541B, enabling the two ends of suture1541to be easily tied.

As can be seen inFIG. 16B, padding1546may be of a cylindrical shape and suture1541may pass through any appropriate section of its interior. Moreover, suture1541may generally be connected at midpoint1554of padding1546.

In an alternative embodiment, strings1541A and1541B may be separately connected to padding1546or they may be formed from a doubling over of suture1541.

Padding1546may be formed of any suitable material which may be bio-compatible and may be flexible enough to fold and through which suture1541may be threaded and pulled. For example, as shown inFIG. 16A, padding1546may be a generally cylindrical shape made of a braided material and/or may be made with a braid similar to that of a shoestring. Alternatively, padding1546may be formed from a bio-compatible silicone or plastic. Furthermore, padding1546may be any suitable bio-compatible material which may be flexible and foldable, and through which suture1541may be threaded, as described hereinbelow.

Reference is now made toFIGS. 16C and 16D, which illustrate a threader1558useful in threading PTS1540. As shown inFIG. 16C, threader1558may comprise a handle1560and a threading loop1562, typically made of any suitable, thin, flexible wire. Prior to implantation and/or during manufacture, handle1560may be threaded through padding1546, with threading loop1562left external to padding1546. As shown inFIG. 16D, suture1541may be threaded through loop1562prior to its being pulled through padding1546during the implantation process, thereby threading both strings of suture1541through padding1546.

Reference is now made toFIGS. 17A-17K, which illustrate the process of implanting PTS1540into bone1530.FIGS. 17A-17Kgenerally show the bone in a side view and thus, for clarity, do not always show both strings of suture1541.

FIG. 17Ashows bone1530after creating transosseous tunnels1526and1528. The transosseous process leaves a wire shuttle1570threaded through tunnels1526and1528, and through a cut1571in the skin. Note that tendon1529is not yet connected to bone1530.

Shuttle1570has a loop1572into which a surgeon may thread strings1541A and1541B of suture1541, as shown inFIG. 17B. At this stage, handle1560is still held within padding1546.FIG. 17Balso shows a second set of exit holes1573for the second PTS1540so that a surgeon may tie a criss-cross stitch. The remaining discussion will show the process on only one PTS1540.

The surgeon may pull wire shuttle1570through bone1530, thereby replacing wire shuttle1570with suture1541. Using appropriate surgical tools, such as suture passers, the surgeon may then pass suture1541through tendon1529and back out of the body through cut1571. The result is shown inFIG. 17C.

Typically a tendon to be repaired will have non-straight edge. The surgeon may pass suture1541through a point1545some distance behind the tear. During the process described hereinbelow, this point may be pulled forward towards the opening of the transosseous tunnel.

Outside of the body, the surgeon may now thread suture1541through wire loop1562of handle1560, as shown inFIG. 17D. Pulling handle1560(FIG. 17E) may pull suture1541through padding1546, thereby creating a loop from suture1541, which is now looped through padding1546.

Due to the threading of suture1541within padding1546, continued pulling on the portion1580of suture1541, which is outside of the body and not past padding1546, may bring padding1546towards cut1571in the skin (FIG. 17F). As shown inFIG. 17G, further pulling on portion1580may cause padding1546to bend, due to the connection of suture1541to generally the middle of padding1546, as padding1546is pulled through cut1571. Still further pulling on portion1580may pull bent padding1546towards and into opening1527of first tunnel1526(FIG. 17H).

Continued pulling on portion1580will fold padding1546and bring it fully into first tunnel1526(FIG. 17I). The surgeon may pull padding1546through tunnel1526until padding1546stops. This may be at any point within tunnel1526but it will not extend beyond the intersection of the first tunnel and the second tunnel1528where the angle would require applying additional force to be applied in order to overcome the friction and resistance of moving around the angle of the turn. At this point, with padding1546fixed in place, suture1541may be tightened. There are two steps to this:

1) Pulling on extending segment1552, exiting first tunnel1528. This will pull suture1541through padding1546such that suture1541will lie tightly on the bone, as shown inFIG. 17J; and

2) Still further pulling on extending segment1552, until it cannot be pulled any more. This will stretch tendon1529and bring it to its place over second tunnel1528, as shown inFIG. 17K.

Finally, with suture1541tightly fastened and tendon1529in place, extending segment1552of suture1541may be tied together (recall that there are two of them) in a knot over cut1571, in a criss-cross knot, a button closure or with any other suitable closure. After this, suture1541may be cut.

It will be appreciated that suture1541may be fixed due to frictions in tunnel1526, from padding against the walls of tunnel1526but also from the fact that padding1546is folded. Moreover, pulling on the portions of suture1541external to the skin may pull on fold1554of padding1546, which, in turn, may pull on padding segments1544, which are connected to the external pulled portions.

It will be appreciated that, at any time during the process, padding1546may be pulled out of the joint, by pulling backwards on segment1580or on extending segment1552. Similarly, padding1546may be pulled out after cutting suture1541.

It will be appreciated that, by pulling padding1546from behind and through a thin opening, padding1546may be forced to bend, which creates a strong friction connection to first tunnel1526in the bone.

It will be appreciated that the present invention may be utilized with any suitable transosseous tunnel(s). For example and as shown inFIG. 18, to which reference is now made, PTS1540may be threaded through a circular tunnel1590rather than through two tunnels1526and1528.