HK1238523B - Padded transosseous suture - Google Patents

Description

Padded transosseous sutures

Reference to related applications

Reference is made to U.S. Provisional Patent Application No. 62/047,674, filed on September 9, 2014, entitled “Padded Transosseous Suture,” the contents of which are hereby incorporated by reference and priority is hereby claimed under 37 CFR 1.78(a)(4) and (5)(i).

Technical Field

The present invention relates to a bone-penetrating suture and a method of using the same.

Background Art

Various types of transosseous sutures are known in the art.

It is understood that the term "suture" as used herein refers to any suitable suture and also refers to a delivery wire or a pull wire used to pull a suture through bone. Typically, a delivery wire is used in the systems and methods of the present invention and is formed from nickel-titanium alloy (Nitinol). Typically, a delivery wire used in the systems and methods of the present invention is folded to form a loop at one end.

Summary of the Invention

The present invention seeks to provide improved transbone sutures.

Therefore, according to a preferred embodiment of the present invention, a bone suture assembly is provided, which includes: a flexible, generally cylindrical sleeve; multiple lengths of suture extending through the generally cylindrical sleeve; and at least one sleeve fixing yarn associated with the generally cylindrical sleeve.

Preferably, the generally cylindrical sleeve is deformable. Furthermore, the suture assembly includes at least one yarn associated with the deformable cylindrical sleeve for selectively deforming the generally cylindrical sleeve. Furthermore, the at least one selectively deformable yarn includes a yarn that is looped through a plurality of perforations located at opposite ends of the generally cylindrical sleeve and, when pulled, draws the opposite ends toward each other, thereby deforming the generally cylindrical sleeve.

Preferably, the approximately cylindrical sleeve is bendable but not deformable. Additionally or alternatively, the approximately cylindrical sleeve is formed with a flange at one end thereof. Additionally or alternatively, the at least one sleeve-fixing yarn comprises at least one yarn, the at least one yarn being attached to the approximately cylindrical sleeve at one end thereof. Additionally or alternatively, the at least one sleeve-fixing yarn comprises at least one yarn, the at least one yarn being looped at one end thereof through a perforation formed in the approximately cylindrical sleeve. Still additionally or alternatively, the at least one sleeve-fixing yarn comprises at least one yarn, the at least one yarn being sewn along the approximately cylindrical sleeve and having two free ends extending beyond both ends of the approximately cylindrical sleeve.

According to a preferred embodiment of the present invention, the suture assembly further comprises a flexible second outer sleeve, the flexible second outer sleeve being fixed to and at least partially surrounding the flexible, generally cylindrical sleeve. In addition, the flexible second outer sleeve is non-deformable, and the flexible second outer sleeve comprises a cylindrical portion and a conical portion, the cylindrical portion having a diameter approximately matching the diameter of the exterior of the generally cylindrical sleeve, and the conical portion extending beyond the generally cylindrical sleeve. Alternatively, the flexible second outer sleeve is generally cylindrical and is generally shorter than the generally cylindrical flexible sleeve, and the second outer sleeve is deformable.

According to a preferred embodiment of the flexible generally cylindrical sleeve, the flexible generally cylindrical sleeve is a generally cylindrical braided sleeve. Furthermore, the generally cylindrical sleeve can be pre-stressed such that a convex portion is formed adjacent to one end of the generally cylindrical braided sleeve; and the pre-stressed generally cylindrical braided sleeve can be stretched into a generally cylindrical shape.

According to another preferred embodiment of the present invention, a bone suture retaining method is provided, which includes: engaging a suture and a bone engaging sleeve; pulling the bone engaging sleeve into a transbone tunnel formed in a bone, so that the suture and the bone engaging sleeve engaged therethrough are inserted into the transbone tunnel; and preventing the bone engaging sleeve from properly passing through a perforation in the bone, thereby retaining the suture and the bone engaging sleeve in the transbone tunnel.

Preferably, the perforation in the bone is formed in the cortical bone. Alternatively, the perforation in the bone is formed in the bone marrow.

Preferably, the pulling is achieved by pulling a flexible elongated member attached to the sleeve. Additionally or alternatively, the method comprises deforming the bone engagement sleeve within the transbone tunnel by pulling an elongated member attached to the bone engagement sleeve, and thereby further engaging the bone engagement sleeve in the transbone tunnel.

According to a preferred embodiment of the present invention, the suture retention method includes deforming the bone engagement sleeve and a flexible and deformable outer sleeve fixed thereto together. Alternatively, the method includes expanding a flexible, conical outer sleeve fixed to the bone engagement sleeve after the bone engagement sleeve enters the transbone tunnel.

According to a preferred embodiment of the present invention, the bone engaging sleeve is knitted, and the method includes: pre-pressing the bone engaging sleeve to form a convex portion near one end thereof; stretching the bone engaging sleeve before the insertion; and releasing the bone engaging sleeve after the insertion to allow the convex portion to re-expand.

Therefore, according to another preferred embodiment of the present invention, there is further provided a suture comprising: a threadable pad; and at least one suture engaged with an outer surface of the pad, the pad having a shape that allows the suture to be threaded through an interior of the pad.

According to yet another preferred embodiment of the present invention, there is further provided a suture comprising: a threadable liner; a threader that passes through the liner, the threader having a loop thereon at one end of the threader; and at least one suture that is engaged through an outer surface of the liner and threaded through the loop, the liner having a shape that enables the loop to be threaded through the liner.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will be more fully understood and appreciated from the following detailed description with reference to the accompanying drawings, in which:

1A and 1B are respectively a simplified schematic diagram and a cross-sectional view of a bone-penetrating suture assembly constructed and operating in a first operating position according to a preferred embodiment of the present invention;

2A and 2B are respectively a simplified schematic diagram and a cross-sectional view of the bone-penetrating suture assembly of FIG. 1A and FIG. 1B in a second operational orientation;

3A and 3B are respectively a simplified schematic diagram and a cross-sectional view of a bone-penetrating suture assembly constructed and operated in a first operating position according to another preferred embodiment of the present invention;

4A and 4B are respectively a simplified schematic diagram and a cross-sectional view of the bone-penetrating suture assembly of FIG. 3A and FIG. 3B in a second operational orientation;

5A and 5B are respectively a simplified schematic diagram and a cross-sectional view of a bone-penetrating suture assembly constructed and operated in a first operating position according to yet another preferred embodiment of the present invention;

6A and 6B are respectively a simplified schematic diagram and a cross-sectional view of the bone-penetrating suture assembly of FIG. 5A and FIG. 5B in a second operational orientation;

7A and 7B are respectively a simplified schematic diagram and a cross-sectional view of a bone-penetrating suture assembly constructed and operated in a first operating orientation according to yet another preferred embodiment of the present invention;

8A and 8B are respectively a simplified schematic diagram and a cross-sectional view of a bone-penetrating suture assembly constructed and operated in a first operating orientation according to a further preferred embodiment of the present invention;

9A and 9B are respectively a simplified schematic diagram and a cross-sectional view of a bone-penetrating suture assembly constructed and operated in a first operating orientation according to a further preferred embodiment of the present invention;

10A and 10B are respectively a simplified schematic diagram and a cross-sectional view of a bone-penetrating suture assembly constructed and operated in a first operating orientation according to a further preferred embodiment of the present invention;

11A and 11B are simplified schematic and cross-sectional views of the bone-penetrating suture assembly of FIG. 10A and FIG. 10B , respectively, in a second operational orientation;

12A , 12B, 12C, 12D, and 12E are simplified schematic diagrams of some preliminary stages of insertion of a transbone suture assembly of any of the embodiments depicted in FIGS. 1A to 11B ;

13A, 13B, 13C, 13D, 13E, 13F, and 13G are simplified cross-sectional illustrations of the penultimate stages of insertion of the various embodiments of the transbone suture assembly depicted in FIGS. 1A to 2B, 3A to 4B, 5A to 6B, 7A and 7B, 8A and 8B, 9A and 9B, and 10A to 11B;

14 is a simplified schematic diagram of the final stage of insertion of the entire transbone suture assembly of the various embodiments depicted in FIG. 1A to 11B ;

15A and 15B are cross-sectional and solid schematic views of a padded transosseous suture configuration constructed and operated in situ according to yet another further embodiment of the present invention, wherein the suture is passed through a protective fixation sleeve;

16A and 16B are respectively a schematic diagram and a cross-sectional view of a protective retaining sleeve and a cross-sectional view of a suture passing through the sleeve before implantation;

FIG16C is a schematic diagram of a needle threader for the suture of FIG16A;

FIG16D is an intentional view of the sleeve and suture of FIG16A prior to implantation, with the threader of FIG16C passed through the sleeve;

17A, 17B, 17C, 17D, 17E, 17F, 17G, 17H, 17I, 17J and 17K are schematic diagrams illustrating a process of implanting the padded transosseous suture of FIG. 16A to 16D; and

FIG. 18 is a schematic diagram of an alternative embodiment of the present invention.

It will be appreciated that for simplicity and clarity of illustration, the line segments shown in the drawings are not necessarily drawn to scale. For example, the dimensions of some of the line segments may be exaggerated relative to other line segments for clarity. Furthermore, where deemed appropriate, reference numerals may be repeated among the various drawings to indicate corresponding or similar line segments.

DETAILED DESCRIPTION

In the following detailed description, numerous specific details are disclosed in order to provide a complete understanding of the present invention. However, it will be appreciated by those skilled in the art that the present invention may be practiced without these specific details. In other instances, well-known methods, procedures, and components have not been described in detail to avoid obscuring the present invention.

Reference is now made to Figures 1A and 1B, which are simplified schematic and cross-sectional views, respectively, of a transbone suture assembly constructed and operating in a first operating orientation according to a preferred embodiment of the present invention. As shown in Figures 1A and 1B, the transbone suture assembly preferably includes a flexible and deformable sleeve 100, which is preferably formed of a polyester mesh (such as polyester polyetheretherketone or nylon, or nickel-titanium alloy or cotton). The flexible and deformable sleeve 100 includes: a generally circular cylindrical main portion 102 having a first outer diameter, the first outer diameter being generally slightly less than 3.2 mm in the first operating orientation when the sleeve 100 is in a released, extended state; and an outwardly extending flange portion 104 having a second outer diameter that is larger than the first outer diameter of the main portion 102. A through hole 106 extends from a first end 108 of the flexible and deformable sleeve 100 to a second end 110 of the flexible and deformable sleeve 100 at the flange portion 104 .

A first flexible yarn 112 is attached to the flexible and deformable sleeve 100 at a first end 108 adjacent to the flexible and deformable sleeve 100 and has a free end 113 extending beyond the first end 108; and a second flexible yarn 114 is attached to the flexible and deformable sleeve 100 at a second end 110 adjacent to the flexible and deformable sleeve 100 and has a free end 115 extending beyond the second end 110. A sleeve shortening yarn 120 is preferably threaded through a perforation 126 at one end 122 thereof adjacent the first end 108 of the flexible and deformable sleeve 100, and extends along most of the sleeve length to and through a perforation 124 at the second end 110 adjacent the flexible and deformable sleeve 100, and is looped back and secured to the first end 125 of the sleeve shortening yarn 120 adjacent the perforation 126, and has a free end 130 extending beyond the end 108.

Multiple lengths of suture (typically three in number) are collectively designated herein by reference numeral 140 and extend through the flexible and deformable sleeve 100 and beyond the ends 108 and 110 of the flexible and deformable sleeve 100 .

Reference is now made to Figures 2A and 2B, which are simplified schematic and cross-sectional views, respectively, of the transosseous suture assembly of Figures 1A and 1B in a second operational orientation, achieved by pulling on the free end 130 of the sleeve shortening yarn 120 while simultaneously maintaining the flexible and deformable sleeve 100. As shown in Figures 2A and 2B, and compared to Figures 1A and 1B, the entire length of the loops of the sleeve shortening yarn 120 extending through the perforations 124 and 126 is shortened, thereby longitudinally shortening and deforming the flexible and deformable sleeve 100, generally as shown. This effectively widens the diameter of the flexible and deformable sleeve 100.

Reference is now made to Figures 3A and 3B, which are simplified schematic and cross-sectional views, respectively, of a transosseous suture assembly constructed and operating in a first operating orientation according to another preferred embodiment of the present invention. As shown in Figures 3A and 3B, the transosseous suture assembly preferably includes a flexible and deformable sleeve 300, which is preferably formed from a polyester mesh (such as polyester-polyetheretherketone or nylon, or nickel-titanium alloy or cotton). The flexible and deformable sleeve 300 includes a generally circular cylindrical main portion 302 having a first outer diameter, which is typically slightly less than 3.2 mm in a released, extended state; and an outwardly extending flange portion 304 having a second outer diameter that is larger than the first outer diameter of the main portion 302. A through hole 306 extends from a first end 308 of the flexible and deformable sleeve 300 to a second end 310 of the sleeve located at the flange portion 304.

A first flexible yarn 311 is attached to the flexible and deformable sleeve 300 by being looped through a through-hole 312 formed adjacent to the first end 308 of the flexible and deformable sleeve 300, and has two free ends 313 extending beyond the first end 308; and a second flexible yarn 314 is attached to the flexible and deformable sleeve 300 at the second end 310 adjacent to the flexible and deformable sleeve 300, and has a free end 315 extending beyond the second end 310. A sleeve shortening yarn 320 is preferably threaded through a perforation 326 at one end 322 thereof located adjacent the first end 308 of the flexible and deformable sleeve 300, and extends along most of the sleeve length to and through a perforation 324 at the second end 310 adjacent the flexible and deformable sleeve 300, and is looped back and secured to the first end 325 of the sleeve shortening yarn 320 near the perforation 326, and has a free end 330 extending beyond the end 308.

Multiple lengths of suture (typically three in number) are collectively designated herein by reference numeral 340 and extend through the flexible and deformable sleeve 300 and beyond the ends 308 and 310 of the flexible and deformable sleeve 300 .

Reference is now made to Figures 4A and 4B, which are simplified schematic and cross-sectional views, respectively, of the transosseous suture assembly of Figures 3A and 3B in a second operational orientation, achieved by pulling on the free end 330 of the sleeve shortening yarn 320 while maintaining the flexible and deformable sleeve 300. As shown in Figures 4A and 4B and compared to Figures 3A and 3B, the entire length of the loops of the sleeve shortening yarn 320 extending through the perforations 324 and 326 is shortened, thereby longitudinally shortening and deforming the flexible and deformable sleeve 300, as generally shown. This effectively widens the diameter of the flexible and deformable sleeve 300 and increases its diameter to a second outer diameter that is larger than the first outer diameter in the first operational orientation shown in Figures 3A and 3B.

Reference is now made to Figures 5A and 5B, which are simplified schematic and cross-sectional views, respectively, of a transbone suture assembly constructed and operating in a first operating orientation according to yet another preferred embodiment of the present invention. As shown in Figures 5A and 5B, the transbone suture assembly preferably includes a flexible and deformable sleeve 500, which is preferably formed from a polyester mesh (such as polyester polyetheretherketone or nylon, or nickel-titanium alloy or cotton). The flexible and deformable sleeve 500 includes a generally circular cylindrical main portion 502 having a first outer diameter, which is typically slightly less than 3.2 mm in a released, extended state; and an outwardly extending flange portion 504 having a second outer diameter that is larger than the first outer diameter of the main portion 502. A through hole 506 extends from a first end 508 of the flexible and deformable sleeve 500 to a second end 510 of the sleeve located at the flange portion 504.

A first flexible yarn 512 is attached to the flexible and deformable sleeve 500 at a first end 508 adjacent to the flexible and deformable sleeve 500 and has a free end 513 extending beyond the first end 508; and a second flexible yarn 514 is attached to the flexible and deformable sleeve 500 at a second end 510 adjacent to the flexible and deformable sleeve 500 and has a free end 515 extending beyond the second end 510. A sleeve shortening yarn 520 is preferably threaded through a perforation 526 at one end 522 thereof located adjacent the first end 508 of the flexible and deformable sleeve 500, and extends along most of the sleeve length to and through a perforation 524 at the second end 510 adjacent the flexible and deformable sleeve 500, and is looped back and secured to the first end 525 of the sleeve shortening yarn 520 near the perforation 526, and has a free end 530 extending beyond the end 508.

A plurality of lengths of suture (typically three in number) are collectively designated herein as reference numeral 540 and extend through the flexible and deformable sleeve 500 and beyond both ends 508 and 510 of the flexible and deformable sleeve 500. Attached proximate the first end 508 of the flexible and deformable sleeve 500 is an outer second sleeve 550 having a diameter approximately equal to the diameter of the exterior of the generally circular cylindrical main portion 502 so that the flexible and deformable sleeve 500 can be inserted into and engaged within the outer second sleeve 550. The outer second sleeve 550 typically extends two-thirds to three-quarters of the length of the flexible and deformable sleeve 500 to an end 560 and is preferably formed of a polyester mesh (such as polyester polyetheretherketone or nylon, or nickel titanium alloy or cotton) and is flexible and deformable. The first flexible yarn 512 , in addition to being attached to the flexible and deformable sleeve 500 , is also attached to the outer second sleeve 550 adjacent the first end 508 of the flexible and deformable sleeve 500 .

6A and 6B , which are simplified schematic and cross-sectional views, respectively, of the transosseous suture assembly of FIG5A and 5B in a second operational orientation, achieved by pulling on the free end 530 of the sleeve shortening yarn 520 while maintaining the flexible and deformable sleeve 500. As shown in FIG6A and 6B and compared to FIG5A and 5B , the entire length of the loop of the sleeve shortening yarn 520 extending through the perforations 524 and 526 is shortened, thereby longitudinally shortening and deforming the flexible and deformable sleeve 500, generally as shown, with the flexible and deformable sleeve 500 and the outer second sleeve 550 both contracting between the end 560 of the outer second sleeve 550 and the first end 508 of the flexible and deformable sleeve 500. This effectively increases the diameter of the combined flexible and deformable sleeve 500 and outer second sleeve 550 between the end 560 of the outer second sleeve 550 and the first end 508 of the flexible and deformable sleeve 500. Including the outer second sleeve 550 significantly increases the total amount of material in the constriction region between the end 560 of the outer second sleeve 550 and the first end 508 of the flexible and deformable sleeve compared to the flexible and deformable sleeve 500 alone, and thus creates a dual sleeve having a larger overall diameter.

Reference is now made to Figures 7A and 7B, which are simplified schematic and cross-sectional views, respectively, of a transbone suture assembly constructed and operated according to yet another preferred embodiment of the present invention. As shown in Figures 7A and 7B, the transbone suture assembly preferably includes a flexible sleeve 700, which is preferably formed of a polyester mesh (such as polyester polyetheretherketone or nylon, or nickel-titanium alloy or cotton). The flexible sleeve 700 includes: a generally circular cylindrical main portion 702, the cylindrical main portion 702 having a first outer diameter, the first outer diameter being generally slightly less than 3.2 mm; and an outwardly extending flange portion 704, the outwardly extending flange portion 704 having a second outer diameter, the second outer diameter being larger than the first outer diameter of the main portion 702. A through hole 706 extends from a first end 708 of the flexible sleeve 700 to a second end 710 of the sleeve.

A flexible yarn 712 is loosely stitched along the length of the flexible sleeve 700 from a position adjacent to the first end 708 of the flexible sleeve 700, with a free end 713 extending beyond the first end 708 to a position adjacent to the second end 710 of the flexible sleeve 700, with a free end 715 extending beyond the second end 710. The flexible yarn 712 in this embodiment is an alternative to having first and second yarns attached to the flexible sleeve 700 (see FIG. 13D below); the flexible sleeve 700 can be manufactured so that the flexible yarn 712 is embedded therein, thereby eliminating the need to manually secure or loop the yarn within the flexible sleeve 700. Multiple lengths of stitching (typically three in number) are collectively designated herein as reference numeral 740 and extend through the flexible sleeve 700 and beyond the ends 708 and 710 of the flexible sleeve 700.

Reference is now made to Figures 8A and 8B, which are simplified schematic and cross-sectional views, respectively, of a transbone suture assembly constructed and operative according to a further preferred embodiment of the present invention. As shown in Figures 8A and 8B, the transbone suture assembly preferably includes a flexible sleeve 800, which is preferably formed of a polyester mesh (such as polyester polyetheretherketone or nylon, or nickel-titanium alloy or cotton). The flexible sleeve 800 includes: a generally circular cylindrical main portion 802 having a first outer diameter, which is typically slightly less than 3.2 mm; and an outwardly extending flange portion 804 having a second outer diameter, which is larger than the first outer diameter of the main portion 802. A through hole 806 extends from a first end 808 of the flexible sleeve 800 to a second end 810 of the sleeve located at the flange portion 804.

A first flexible yarn 812 is attached to the flexible sleeve 800 adjacent a first end 808 of the flexible sleeve 800 and has a free end 813 extending beyond the first end 808; and a second flexible yarn 814 is attached to the flexible sleeve 800 adjacent a second end 810 of the flexible sleeve 800 and has a free end 815 extending beyond the second end 810. Optionally, as shown, a tightening yarn 820 is threaded through a through-hole 826 at one end 822 of the flexible sleeve 800 adjacent the first end 808, extends along most of the sleeve length to and through a through-hole 824 adjacent the second end 810 of the flexible sleeve 800, is looped back and secured to a first end 825 of the tightening yarn 820 adjacent the through-hole 826, and has a free end 830 extending beyond the end 808.

Multiple lengths of suture (typically three in number) are collectively designated herein by reference numeral 840 and extend through the flexible sleeve 800 and beyond both ends 808 and 810 of the flexible sleeve 800. Attached near the first end 808 of the flexible sleeve 800 is a flared outer second sleeve 850 having a cylindrical portion and a conical portion, the cylindrical portion having a diameter that approximately matches the diameter of the outer portion of the generally circular cylindrical main portion 802 near the first end 808 and increasing in diameter toward the second end 810 of the flexible sleeve 800. The flared outer second sleeve 850 has a horn-like shape that is open at end 860 and is flexible.

Reference is now made to Figures 9A and 9B, which are simplified schematic and cross-sectional views, respectively, of a transbone suture assembly constructed and operated in accordance with a further preferred embodiment of the present invention. As shown in Figures 9A and 9B, the transbone suture assembly preferably includes a flexible sleeve 900, which is preferably formed of a polyester mesh (such as polyester polyetheretherketone or nylon, or nickel-titanium alloy or cotton). The flexible sleeve 900 includes: a generally circular cylindrical main portion 902, the cylindrical main portion 902 having a first outer diameter, the first outer diameter being generally slightly less than 3.2 mm; and an outwardly extending flange portion 904, the outwardly extending flange portion 904 having a second outer diameter, the second outer diameter being larger than the first outer diameter of the main portion 902. A through hole 906 extends from a first end 908 of the flexible sleeve 900 to a second end 910 of the sleeve.

A first flexible yarn 912 is attached to the flexible sleeve 900 adjacent a first end 908 of the flexible sleeve 900 and has a free end 913 extending beyond the first end 908; and a second flexible yarn 914 is attached to the flexible sleeve 900 adjacent a second end 910 of the flexible sleeve 900 and has a free end 915 extending beyond the second end 910. Multiple lengths of suture (typically three in number) are collectively designated herein as reference numeral 940 and extend through the flexible sleeve 900 and beyond both ends 908 and 910 of the flexible sleeve 900.

Reference is now made to Figures 10A and 10B, which are simplified schematic and cross-sectional views, respectively, of a transbone suture assembly constructed and operating in a first operating orientation according to a further preferred embodiment of the present invention. As shown in Figures 10A and 10B, the transbone suture assembly preferably includes a flexible and deformable braided sleeve 1000, which is preferably formed from a polyester mesh (such as polyester polyetheretherketone or nylon, or nickel-titanium alloy or cotton). The flexible and deformable braided sleeve 1000 includes: a generally circular cylindrical main portion 1002 having a first outer diameter, which is generally slightly less than 3.2 mm in a released, extended state; and an outwardly extending flange portion 1004 having a second outer diameter, which is larger than the first outer diameter of the main portion 1002. A through hole 1006 extends from a first end 1008 of the flexible and deformable braided sleeve 1000 to a second end 1010 of the sleeve at the flange portion 1004 .

A first flexible yarn 1011 is attached to the flexible and deformable braided sleeve 1000 by being looped through a through-hole 1012 formed therein adjacent a first end 1008 of the flexible and deformable braided sleeve 1000 and has two free ends 1013 extending beyond the first end 1008; and a second flexible yarn 1014 is attached to the flexible and deformable braided sleeve 1000 adjacent a second end 1010 of the flexible and deformable braided sleeve 1000 and has a free end 1015 extending beyond the second end 1010. In an alternative embodiment, the first flexible yarn 1011 is secured to the flexible and deformable braided sleeve 1000 at the through-hole 1012 adjacent the first end 1008 and has a free end 1013 extending beyond the first end 1008. A tightening yarn 1020 is preferably threaded through a perforation 1026 at one end 1022 of the tightening yarn 1020 located adjacent the first end 1008 of the flexible and deformable braided sleeve 1000, and extends along most of the sleeve length to and through a perforation 1024 at the second end 1010 adjacent the flexible and deformable braided sleeve 1000, and is looped back and secured to the first end 1025 of the tightening yarn 1020 near the perforation 1026, and has a free end 1030 extending beyond the end 1008.

A plurality of lengths of suture (typically three in number) are collectively designated herein as element number 1040 and extend through the flexible and deformable braided sleeve 1000 and beyond both ends 1008 and 1010 of the flexible and deformable braided sleeve 1000. At a flange 1004 adjacent the second end 1010 of the flexible and deformable braided sleeve 1000, the flexible and deformable braided sleeve 1000 has been pre-stressed or pre-formed as shown, with a ridge 1050 formed therein having an outer diameter typically of about 6 mm. As shown in Figures 10A and 10B, the pre-stressed flexible and deformable braided sleeve 1000 is in a released state. In an alternative embodiment, the flexible and deformable braided sleeve 1000 is not pre-stressed and is therefore generally cylindrical without the ridge 1050 pre-formed.

Reference is now made to Figures 11A and 11B, which are simplified schematic and cross-sectional views, respectively, of the transbone suture assembly of Figures 10A and 10B in a second operational orientation, achieved by pulling on the free end 1013 of the first flexible yarn 1011 while simultaneously retaining the second flexible yarn 1014. As shown in Figures 11A and 11B and compared to Figures 10A and 10B, the overall length of the flexible and deformable braided sleeve 1000 is increased, thereby longitudinally stretching and deforming the flexible and deformable braided sleeve 1000, particularly flattening the preformed convex portion 1050, as generally shown. This effectively reduces the diameter of the flexible and deformable braided sleeve 1000 to a nearly uniform diameter, typically slightly less than 3.2 in diameter.

It will be appreciated that in an alternative embodiment having a flexible and deformable braided sleeve 1000 that is not pre-stressed, the flexible and deformable braided sleeve 1000 will appear as shown in Figures 11A and 11B when in a released state.

Reference is now made to Figures 12A, 12B, 12C, 12D, and 12E, which together are simplified schematic illustrations of some preliminary stages of insertion of a transbone suture assembly of any of the embodiments depicted in Figures 1A-11B.

With particular reference to FIG12A, which is a simplified schematic diagram of a first stage of insertion of a transbone suture assembly into a bone, it can be seen that a first coil of a transmission wire 1200 has been inserted into a side through-hole 1202 formed in a bone and has been drawn through the bone until it exits a top through-hole 1204 formed in the bone. The loop 1206 of the first coil of the transmission wire 1200 extends out of the top through-hole, and a pair of loose ends 1208 of the first coil of the transmission wire 1200 extend out of the side through-hole 1202. It should be noted (as shown in FIG13A through 13G below) that the top through-hole 1204 is generally narrower than the side through-hole 1202 and intersects the side through-hole 1202 at a substantially right angle within the bony portion of the bone.

12B , which is a simplified schematic diagram of a second stage of insertion of a transbone suture assembly into a bone, shows that a second coil of transmission wire 1210 has been inserted into loop 1206 of the first coil of transmission wire 1200 extending beyond the top through-hole 1204 in the bone. Loop 1216 of the second coil of transmission wire 1210 extends through loop 1206 of the first coil of transmission wire 1200, while a pair of loose ends 1218 of the second coil of transmission wire 1210 extend beyond loop 1206 of the first coil of transmission wire 1200. Following this second stage of insertion of the transbone suture assembly into the bone, the first coil of transmission wire 1200 is drawn from the top through-hole 1204 through the bone and through the side through-hole 1202, while the second coil of transmission wire 1210 is drawn through the bone.

12C , which is a simplified schematic diagram of a third stage of insertion of a transbone suture assembly into a bone. At this stage, it can be seen that the second coil of transmission wire 1210 has been drawn through the top through-hole 1204 (as described above with reference to FIG. 12B ) and out of the side through-hole 1202. The loop 1206 now extends out of the side through-hole 1202, while the pair of slack ends 1218 extend out of the top through-hole 1204, thereby positioning the second coil of transmission wire 1210 in the reverse position of the first coil of transmission wire 1200, as shown in FIG. 12A .

12D , which is a simplified schematic diagram of a fourth stage of insertion of a transbone suture assembly into a bone, showing a transbone suture 1240 having been inserted through the loop 1216 of the second coil of delivery wire 1210 extending beyond the lateral through hole 1202 in the bone. The transbone suture 1240 comprises a generally cylindrical portion 1242 having a plurality of sutures 1244 (typically three) threaded through a through hole 1246 formed in the generally cylindrical portion 1242 and extending from a first end 1248 to a second end 1250 of the generally cylindrical portion 1242 of the transbone suture 1240, and an outwardly extending flange portion 1251. It will be understood that when referring to the transbone suture 1240 herein, any of the embodiments of the flexible sleeve of the present invention as defined above is intended. The suture 1244 has a free end 1252 at a first end 1248 (shown as extending through the loop 1216 of the second coil of the delivery wire 1210) and a free end 1254 (extending from the second end 1250 of the generally cylindrical portion 1242 of the transbone suture 1240). After this fourth stage of insertion of the transbone suture assembly into the bone, the second coil of the delivery wire 1210 is drawn from the side through-hole 1202 through the bone and through the top through-hole 1204, drawing the transbone suture 1240 into the side through-hole 1202 in the bone. Sutures 1262 and 1264, now extending from the top through-hole 1204 and the side through-hole 1202, respectively, are secured and/or looped through the perforations in the transbone suture 1240.

Reference is now made to FIG12E , which is a simplified schematic diagram of a fifth stage of insertion of a transbone suture assembly into a bone. It can be seen that transbone suture 1240 has been engaged within lateral through-hole 1202 in the bone, and suture 1244 has been drawn through top through-hole 1204 in the bone. At this stage, free end 1252 of transbone suture 1240 extends beyond top through-hole 1204, while free end 1254 at the opposite end of transbone suture 1240 extends beyond lateral through-hole 1202 in the bone. The transbone suture 1240 has become engaged in the side through-hole 1204 and is unable to advance into the top through-hole 1204 because the top through-hole 1204 is narrow and because the nearly right angle formed at the intersection of the top through-hole 1204 and the side through-hole 1202 inhibits passage, as described above with reference to FIG12A, and because the outwardly extending flange portion 1251, which is much larger than the diameter of the side through-hole 1204, inhibits the transbone suture 1240 from passing entirely into the side through-hole 1204. As will be understood and described below, when a locking suture 1280 is present, some embodiments can achieve a tighter engagement in the bone by pulling on the locking suture 1280.

Reference is now made to Figures 13A, 13B, 13C, 13D, 13E, 13F, and 13G, which are simplified cross-sectional views of the penultimate stage of insertion of the various embodiments of the transbone suture assembly depicted in Figures 1A to 2B, Figures 3A to 4B, Figures 5A to 6B, Figures 7A and 7B, Figures 8A and 8B, Figures 9A and 9B, and Figures 10A to 11B (as described above with respect to Figure 12E). Figures 13A, 13B, 13C, 13D, 13E, 13F, and 13G each demonstrate the effect on the suture of pulling a suture attached to a sleeve from the top through-hole while the sleeve is attached to the side through-hole of the bone. It will be appreciated that each of Figures 13A to 13G is a cross-sectional view of Figure 12E, each of which is a preferred embodiment of the present invention, as described and illustrated with respect to Figures 1A to 11B.

Reference is now made to FIG13A , which is a simplified cross-sectional view of the penultimate stage of insertion of the transbone suture assembly of the embodiment illustrated in FIG1A through 2B . As shown, after the flexible and deformable sleeve 100 is first drawn into the side through-hole 1302 as the first flexible yarn 112 is drawn from outside the top through-hole 1304, and after the sleeve shortening yarn 120 is then drawn from outside the top through-hole 1304, the flexible and deformable sleeve 100 described with reference to FIG1A through 2B becomes tightly engaged in the side through-hole 1302 of the bone. Drawing the sleeve shortening yarn 120 expands the midsection of the flexible and deformable sleeve 100, widening it and further engaging it in the bone. Multiple lengths of suture 140 can be seen extending from both the side through-hole 1302 and the top through-hole 1304.

Referring now to FIG. 13B , which is a simplified cross-sectional view of the penultimate stage of insertion of the transbone suture assembly of the embodiment illustrated in FIG. 3A to 4B , as shown, the flexible and deformable sleeve 300 described with reference to FIG. 3A to 4B becomes tightly engaged within the lateral through-hole 1302 of the bone after the first flexible yarn 311 is pulled from outside the top through-hole 1304, first being pulled into the lateral through-hole 1302, and then having the tightening suture 320 pulled from outside the top through-hole 1304. Pulling the tightening suture 320 expands the midsection of the flexible and deformable sleeve 300, widening it and further engaging it within the bone. Optionally, once the flexible and deformable sleeve 300 is fully engaged in the side through-hole of the bone, the first flexible yarn 311 can be pulled through the top through-hole of the bone by one of the free ends 313, thereby being removed from the flexible and deformable sleeve 300. Multiple lengths of suture 340 can be seen extending from both the side through-hole 1302 and the top through-hole 1304.

Referring now to FIG. 13C , which is a simplified cross-sectional view of the penultimate stage of insertion of the transbone suture assembly of the embodiment illustrated in FIG. 5A through 6B , as shown, the flexible and deformable sleeve 500 described with reference to FIG. 5A through 6B and having an outer second sleeve 550 becomes tightly engaged within the bone through-hole 1302 after the flexible and deformable sleeve 500 is first drawn into the side through-hole 1302 and the sleeve shortening yarn 520 is then drawn from outside the top through-hole 1304 as the suture 512 is drawn from outside the top through-hole 1304. Drawing the sleeve shortening yarn 520 causes the midsections of both the flexible and deformable sleeve 500 and the outer second sleeve 550 to expand, widen them, and further engage the flexible and deformable sleeve 500 within the bone. Multiple lengths of suture 540 can be seen extending from both the side through-hole 1302 and the top through-hole 1304 .

Reference is now made to FIG13D , which is a simplified cross-sectional view of the penultimate stage of insertion of the transbone suture assembly of the embodiment illustrated in FIG7A and 7B . As shown, after the flexible sleeve 700 is drawn into the side through-hole 1302 as the flexible yarn 712 is drawn from outside the top through-hole 1304, the flexible sleeve 700 described with reference to FIG7A and 7B becomes engaged in the side through-hole 1302 of the bone. In other embodiments, a suture, either fixed to or looped through a perforation in the sleeve, is used to draw the sleeve into the bone. Multiple lengths of suture 740 can be seen extending from both the side through-hole 1302 and the top through-hole 1304.

Reference is now made to FIG. 13E , which is a simplified cross-sectional view of the penultimate stage of insertion of the transbone suture assembly of the embodiment illustrated in FIGs. 8A and 8B . As shown, after the flexible sleeve 800 is drawn into the side through-hole 1302 as the first flexible yarn 812 is drawn from outside the top through-hole 1304, the flexible sleeve 800 described with reference to FIGs. 8A and 8B becomes tightly engaged within the side through-hole 1302 of the bone. As the flexible sleeve 800 is drawn into the bone, the flared outer second sleeve 850 bends and its outer diameter decreases as it passes into the side through-hole 1302. Once the flared outer second sleeve is within the bony portion of the bone, it returns to a near-original shape and, thereby, widens, creating a tighter fit within the bone. When the optional tightening yarn 820 is attached to the flexible and deformable sleeve 800, the tightening yarn 820 can be used to further tighten the engagement of the flexible sleeve in the bone by tying it together outside the bone, similar to that shown below in Figure 14. Multiple lengths of suture 840 can be seen extending from both the side through-hole 1302 and the top through-hole 1304.

Reference is now made to FIG13F, which is a simplified cross-sectional view of the penultimate stage of insertion of the transbone suture assembly of the embodiment depicted in FIG9A and FIG9B. As shown, after the flexible sleeve 900 is drawn into the side through-hole 1302 while the first flexible yarn 912 is drawn from outside the top through-hole 1304, the flexible sleeve 900 described with reference to FIG9A and FIG9B becomes engaged in the side through-hole 1302 of the bone. Multiple lengths of suture 940 can be seen extending from both the side through-hole 1302 and the top through-hole 1304.

13G , which is a simplified cross-sectional view of the penultimate stage of insertion of the transbone suture assembly of the embodiment illustrated in FIGs. 10A to 11B , as shown, the flexible and deformable braided sleeve 1000 described with reference to FIGs. 10A to 11B becomes tightly engaged within the lateral through-hole 1302 of the bone after the flexible and deformable braided sleeve 1000 is first stretched and then drawn into the lateral through-hole 1302 as the first flexible yarn 1011 is drawn from outside the top through-hole 1304. The stretching compresses the carina 1050 of the flexible and deformable braided sleeve 1000 and causes the flexible and deformable braided sleeve 1000 to approach a generally circular cylindrical shape, thereby allowing the flexible and deformable braided sleeve 1000 to pass into the lateral through-hole 1302 of the bone. Upon entering the bony portion of the bone, and once the tension created by pulling on the first flexible yarn 1011 is released, the flexible and deformable braided sleeve 1000 releases and the preformed protuberance 1050 collapses, firmly securing the flexible and deformable braided sleeve 1000 within the bone, as shown. Optionally, if a tightening yarn 1020 is present, the tightening yarn 1020 can be tied together outside the bone, thereby further tightening the transosseous suture engagement within the bone. Optionally, once the flexible and deformable braided sleeve 1000 is fully engaged within the lateral through-holes of the bone, the first flexible yarn 1011 can be pulled from the top through-hole of the bone via one of its free ends 1013, thereby being removed from the flexible and deformable braided sleeve 1000. Multiple lengths of suture 1040 can be seen extending from both the lateral through-holes 1302 and the top through-holes 1304.

Alternatively, when the flexible and deformable braided sleeve 1000 is not pre-stressed or pre-formed and the flexible and deformable braided sleeve 1000 is in a generally circular cylindrical shape in the released state, when the first flexible yarn 1011 is pulled from outside the top through-hole 1304, the flexible and deformable braided sleeve 1000 becomes tightly engaged in the side through-hole 1302 of the bone after the flexible and deformable braided sleeve 1000 is first pulled into the side through-hole 1302 and then the tightening suture 1020 is pulled from outside the top through-hole 1304. Pulling the tightening yarn 1020 causes the midsection of the flexible and deformable braided sleeve 1000 to expand, widen it, and further engage it in the bone. Optionally, once the flexible and deformable braided sleeve 1000 is fully engaged in the side through hole of the bone, the first flexible yarn 1011 can be pulled from the top through hole of the bone through one of the free ends 1013 so that it is removed from the flexible and deformable braided sleeve 1000.

Reference is now made to FIG. 14 , which is a simplified schematic diagram of the final stage of insertion of the transbone suture assembly for each of the various embodiments depicted in FIG. 1A through 11B . As shown, the two loose ends 1413 and 1415 of sutures 1412 and 1414 (one extending through top through-hole 1404 and the other extending through side through-hole 1402) attached to a sleeve and now loosely engaged in the bone are tightly bound and tied together outside the bone to form a knot 1480. This further secures the transbone suture assembly within the bone. This final step is generally performed for all embodiments of the present invention described above in FIG. 1A through 11B .

Applicants have recognized that while transosseous methods are effective in securing a suture in bone, lining the inner walls of the tunnel will be beneficial in protecting the bone.

Applicants have learned that passing a transbone suture through a protective sleeve protects the bone and also helps secure the suture within the transbone tunnel, preventing movement and subsequent displacement within the tunnel during deployment and subsequent procedures.

Referring now to FIG. 15A , a padded transosseous suture (PTS) 1540, constructed and operative in accordance with a preferred embodiment of the present invention, is illustrated in situ after the PTS 1540 has been implanted in bone 1530. The PTS 1540 may include a suture 1541 (seen in side view in FIG. 15A ) and a liner 1546. The suture 1541 may be generally separable into three segments, a tunnel segment 1542, a liner segment 1544, and an extension segment 1552, with the liner 1546 surrounding a portion of the liner segment 1544. The tunnel segment 1542 may be connected to a trailing section 1548 of the liner 1546 and, when in situ, may extend upward from the posterior portion of the first tunnel 1526, through the tunnel 1528, and through the tendon 1529. It may continue to the pad line segment 1544 on top of the tendon 1529.

When in place, the liner 1546 can be folded within the first tunnel 1526. The liner segment 1544 can extend into the first tunnel 1526 (where it passes through the liner 1546) and can thus also be folded. It can be extended back out of the tunnel 1526 to become an extended segment (reference numeral 1552) which can also be used to tie the suture 1541.

Referring now briefly to FIG. 15B , which is a perspective view of the PTS 1540 after implantation, it can be seen that the suture 1541 is threaded through the tendon 1529 into contact with the bone 1530, while the extension segment 1552 extends from the first tunnel 1526. As shown below in FIG. 16A , the suture 1541 can be threaded through or connected to the liner 1546, thereby providing two separate suture segments. Thus, once the liner 1546 is in place, the two suture segments 1552 can be tied together in a knot at the opening 1527 of the first tunnel 1526. This will prevent the suture 1541 from moving within the tunnel and will keep the tendon 1529 in place.

Applicants have learned that an uncompressed fold in a fabric is typically a thicker area of fabric. Therefore, the folded area (reference numeral 1554) can be an area of greater friction and can be used to position the PTS 1540 within the first tunnel 1526. Therefore, the pad 1546 can be sized so that the pad 1546 can be pressed against the first tunnel 1526 at the fold 1554. Furthermore, because the second tunnel 1528 can be at an angle (e.g., between 40 and 170 degrees) to the first tunnel 1526, the pad 1546 will not migrate into the second tunnel 1528.

It can be appreciated that pad 1546 can hold PTS 1540 in place and can cushion pad segment 1544 from rubbing against the inner surface of first tunnel 1526. Furthermore, due to the connection of tunnel segment 1542 behind fold 1554, tunnel segment 1542 can be significantly retained within the center of second tunnel 1528 and, therefore, also does not rub against the inner surface of second tunnel 1528.

It will also be appreciated that the PTS 1540 can be self-locking within the tunnel 1528 due to friction against the fold 1554. Therefore, the PTS 1540 will generally not move from its final position.

PTS 1540 can be placed within tunnels 1526 and 1528 by pulling tunnel segment 1542 (which can already be located within the tunnels, as described in greater detail below) from the entrance of first tunnel 1526 toward second tunnel 1528. Because tunnel segment 1542 can be connected to trailing segment 1548, it can force liner 1546 to fold in order to enter first tunnel 1528. Pulling tunnel segment 1542 can further pull liner 1546 into first tunnel 1528.

16A and 16B , which illustrate PTS 1540 before it is implanted into bone, show suture 1541 passing through pad 1546, thereby connecting suture 1541 to pad 1546. Passing through or connecting to pad 1546, suture 1541 can have two straps (reference numerals 1541A and 1541B) to allow both ends of suture 1541 to be easily tied.

16B , the liner 1546 can have a cylindrical shape, and the suture 1541 can pass through any suitable section inside it. In addition, the suture 1541 can be connected approximately at the midpoint 1554 of the liner 1546.

In an alternative embodiment, straps 1541A and 1541B may be individually connected to pad 1546 , or straps 1541A and 1541B may be formed by one fold of suture 1541 .

The liner 1546 can be formed from any suitable material that is biocompatible and sufficiently flexible to be foldable, and the suture 1541 can be threaded and drawn through the liner 1546. For example, as shown in FIG16A , the liner 1546 can be generally cylindrical in shape, can be formed from a braided material, and/or can be formed with a braid similar to a shoelace. Alternatively, the liner 1546 can be formed from a biocompatible silicone or plastic. Furthermore, the liner 1546 can be formed from any suitable biocompatible material that is flexible and foldable, and the suture 1541 can be threaded through the liner 1546, as described below.

16C and 16D , which illustrate a threader 1558 for threading the PTS 1540. As shown in FIG16C , the threader 1558 may include a handle 1560 and a threading loop 1562, which is typically formed from any suitable thin, flexible thread. Prior to implantation and/or during manufacture, the handle 1560 may be threaded through the liner 1546, leaving the threading loop 1562 outside the liner 1546. As shown in FIG16D , before the suture 1541 is drawn through the liner 1546 during the implantation procedure, the suture 1541 may be threaded through the loop 1562, thereby threading both strips of suture 1541 through the liner 1546.

17A to 17K, which illustrate the process of implanting a PTS 1540 into a bone 1530. Figures 17A to 17K generally show the bone from a side view, and therefore, for clarity, the two strips of suture 1541 are not always shown.

17A shows the bone 1530 after the creation of the transbone tunnels 1526 and 1528. The transbone process leaves a thread shuttle 1570 being threaded through the tunnels 1526 and 1528 and through an incision 1571 in the skin. It should be noted that the tendon 1529 is still not connected to the bone 1530.

Shuttle 1570 has a loop 1572 into which a surgeon can thread suture strips 1541A and 1541B of suture 1541, as shown in FIG17B . At this stage, handle 1560 remains within liner 1546. FIG17B also shows a second set of exit holes 1573 for a second PTS 1540 so that a surgeon can tie a cross-shaped knot. The remaining discussion will show the process for only one PTS 1540.

The surgeon can pull the wire shuttle 1570 through the bone 1530, replacing the wire shuttle 1570 with the suture 1541. Using appropriate surgical tools, such as a suture passer, the surgeon can then pass the suture 1541 through the tendon 1529 and back out of the body via the incision 1571. The result is shown in FIG17 .

Typically, a tendon to be repaired will have non-straight edges. The surgeon can pass suture 1541 through a point 1545 some distance behind the tear. During the process described below, this point can be pulled forward toward the opening of the bone tunnel.

Outside the body, the surgeon can now thread suture 1541 through the thread loop 1562 of handle 1560, as shown in Figure 17D. Pulling handle 1560 (Figure 17E) can pull suture 1541 through pad 1546, thereby establishing a loop from suture 1541, which is now looped through pad 1546.

Because suture 1541 is threaded within liner 1546, continued pulling on portion 1580 of suture 1541 (which is located outside the body and not passing through liner 1546) can bring liner 1546 toward incision 1571 in the skin ( FIG. 17F ). As shown in FIG. 17G , as liner 1546 is pulled through incision 1571, further pulling on portion 1580 can cause liner 1546 to bend because suture 1541 is connected approximately to the middle of liner 1546. Further pulling on portion 1580 can pull the bent liner 1546 toward and into opening 1527 of first tunnel 1526 ( FIG. 17H ).

Continuously pulling on portion 1580 will fold the liner 1546 and bring it completely into the first tunnel 1526 ( FIG. 17I ). The surgeon can pull the liner 1546 through the tunnel 1526 until the liner 1546 stops. This can be at any point within the tunnel 1526, but it will not extend beyond the intersection of the first tunnel 1526 and the second tunnel 1528, where the angle requires additional force to be applied in order to overcome friction and resistance to movement around the angle of rotation. At this point, with the liner 1546 secured in place, the suture 1541 can be tightened. There are two steps to this:

1) Pull extension wire segment 1552 out of first tunnel 1528. This pulls suture 1541 through liner 1546, causing suture 1541 to lie tightly against the bone, as shown in FIG17J ; and

2) Pull the extension wire segment 1552 still further until it can no longer be pulled. This will stretch the tendon 1529 and bring it to its position above the second tunnel 1528, as shown in FIG17K .

Finally, with the suture 1541 securely fastened and the tendon 1529 in place, the extended segments 1552 of the suture 1541 can be tied together (recall that there are two) in a knot above the incision 1571 in the form of a cross knot, a button closure, or any other suitable closure. After this, the suture 1541 can be cut.

It can be appreciated that suture 1541 can be held in place due to friction within tunnel 1526 (which comes from the padding against the walls of tunnel 1526 and also from the fact that padding 1546 is folded over). Additionally, pulling the portion of suture 1541 outside the skin can pull on fold 1554 of padding 1546, which in turn can pull on padding segment 1544, which is connected to the portion being pulled outside.

It will be appreciated that at any point in the process, the liner 1546 can be pulled out of the joint by pulling back on the lead wire segment 1582 or pulling on the extension wire segment 1552. Similarly, after the suture 1541 is cut, the liner 1546 can be pulled out.

It will be appreciated that by pulling the liner 1546 from the rear and through a skin opening, the liner 1546 can be forced to bend, which creates a strong friction connection to the first tunnel 1526 in the bone.

It will be appreciated that the present invention can be used with any suitable transosseous tunnel. For example and as shown in FIG18 , referring now to FIG18 , the PTS 1540 can be threaded through a circular tunnel 1590 rather than through two tunnels 1526 and 1528 .

While certain features of the present invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those skilled in the art. It is therefore intended that the appended claims encompass all such modifications and changes that fall within the true spirit of the invention.

Claims (12)

1. A bone suture assembly, characterized in that it comprises: A flexible, roughly cylindrical bushing; Multiple lengths of stitches extend through the generally cylindrical bushing; At least one bushing secures the yarn and is associated with the generally cylindrical bushing; and A flexible second outer bushing, the flexible generally cylindrical bushing being attached to the flexible second outer bushing. 2. The bone suture assembly as claimed in claim 1, wherein the generally cylindrical bushing is deformable. 3. The suture assembly of claim 2, wherein the suture assembly further comprises at least one yarn associated with the deformable cylindrical bushing for selectively deforming the generally cylindrical bushing. 4. The suture assembly of claim 3, wherein the at least one yarn for selective deformation comprises a yarn that loops through a plurality of perforations located at two opposite ends of the generally cylindrical bushing, and when pulled, pulls the opposite ends toward each other, thereby deforming the generally cylindrical bushing. 5. The bone suture assembly according to any one of claims 1 to 4, characterized in that the generally cylindrical bushing has a flange formed at one end. 6. The suture assembly according to any one of claims 1 to 4, wherein the at least one bushing fixing yarn comprises at least one yarn attached at one end to the generally cylindrical bushing. 7. The suture assembly according to any one of claims 1 to 4, wherein the at least one bushing fixing yarn comprises at least one yarn that passes through a perforation formed in the generally cylindrical bushing at one end. 8. The suture assembly according to any one of claims 1 to 4, wherein the at least one bushing fixing yarn comprises at least one yarn that is sewn along the generally cylindrical bushing and has two free ends extending beyond both ends of the generally cylindrical bushing. 9. The bone suture assembly according to any one of claims 1 to 4, wherein the flexible second outer bushing at least partially surrounds the flexible, generally cylindrical bushing. 10. The bone suture assembly as claimed in any one of claims 1 to 4, characterized in that: The flexible second outer bushing includes a cylindrical portion and a conical portion; The cylindrical portion has a diameter that approximately matches the diameter of an outer portion of the generally cylindrical bushing; and The conical portion extends beyond the generally cylindrical bushing. 11. The bone suture assembly according to any one of claims 1 to 4, wherein the flexible second outer bushing is a generally cylindrical bushing, and is generally shorter than the generally cylindrical flexible bushing, and the second outer bushing is deformable. 12. The suture assembly according to any one of claims 1 to 4, wherein the flexible, generally cylindrical bushing is a generally cylindrical braided bushing.