This invention relates to a suture anchor for use in reattaching soft tissue to hard tissue.
During some injuries, soft tissue, such as tendons or ligaments, can tear away from hard tissue, such as bone. Accordingly, it becomes necessary to reattach the soft tissue to the bone in order to facilitate the healing process. Various types of devices are used to reattach tissue, such as screws, staples and suture anchors. The instant invention relates to this latter type of attachment device.
Suture anchors may be inserted into a preformed hole made in the hard tissue, while other anchors are self-tapping. The anchors typically include an eyelet or other structure through which lengths of repair suture or working suture are threaded, which working suture is inserted simultaneously with the anchor into the hard tissue. In this regard, in some anchors, the eyelet is disposed exteriorly on the anchor, for example adjacent to or even forming part of a drive head located on the proximal end of the anchor, and in other anchors is formed interiorly within a bore defined inside the anchor. The eyelet may be formed from suture material, as disclosed in U.S. Pat. No. 6 641 597, and in other instances is formed as a rigid and integral component of the anchor body, as disclosed in U.S. Pat. No. 5 584 836. A further suture-engaging structure is disclosed in U.S. Patent Publication No. 2005/0222618, wherein the anchor incorporates a rigid pin disposed transversely across an interior bore defined in the anchor. In this variation, the working sutures are inserted into the proximal end of the anchor bore and looped over the pin to secure the suture to the anchor.
An inserter device or driver may be utilized in conjunction with the anchor to install or drive same into hard tissue and may carry working sutures thereon. For the purpose of providing pull-out resistance once the anchor is installed, some anchors are exteriorly threaded, while others are ribbed or barbed to provide appropriate pull-out resistance.
It has been discovered that increasing the biological integration of the suture anchor with the bone in which the anchor is implanted can reduce rejection potential and speed healing. In this regard, one embodiment of a suture anchor according to the invention is hollow and includes a continuous through-bore, so that the tip or distal end of the anchor, which is embedded in the bone tissue, is open, allowing the permeation/migration of blood, bone marrow, and their components (including platelets and messenchymal stem cells) into the repair site. Such permeation of blood into the through-bore leads to the formation of a blood clot which provides a matrix for tissue growth and releases cytokines and other factors that induce tissue regeneration. Additionally, the anchor may be formed of a bio-absorbable material, which also enhances healing and integration of the suture and anchor into the bone tissue.
The suture anchor according to the invention includes an anchor body having a distal end configured for insertion into hard tissue and a proximal end spaced from the distal end. The anchor body carries thereon a suture engagement structure which cooperates with working suture to attach same to the suture anchor. The suture-engaging structure may, according to one embodiment, be defined by suture material, and may be formed as a continuous loop of suture material having a portion thereof located interiorly of the anchor, such that the working suture is looped over this interior portion of the suture loop to engage the working suture with the anchor.
The suture anchor according to the invention is configured for cooperation with an inserter or driver device. The inserter device includes a handle for manipulating the device and an inserter shaft which supports the suture anchor at the distal end thereof. The inserter device carries working sutures, which working sutures are engaged with the anchor via the suture engagement structure as discussed above, and then extend proximally either interiorly or exteriorly of the inserter device.
Additionally, the suture anchor according to the invention includes a pair of passages which extend generally transversely to the anchor axis, which passages open inwardly into the anchor through-bore and outwardly through the exterior surface of the anchor. The suture-engaging structure, which may be in the form of a loop of suture material as discussed above, extends through these passages which effectively secures the structure to the anchor. In one embodiment, the loop of suture material is knotted and the knot located distally. The knot may be located completely within the bore or only partially within the bore such that a portion of the knot projects distally from the distal end of the suture anchor. The anchor body defines a surface adjacent the knot at the distal end which serves to fix the knot axially in position at the distal end of the anchor when same is loaded with force.
One possible use of the arrangement is in arthroscopic shoulder surgery, wherein the dislocation of soft tissue relative to the bone is a fairly common injury. However, this arrangement may also be utilized for the repair of small joints, such as the elbow, wrist, ankle, hand or foot. The arrangement may additionally be used to reattach small ligaments in the knee or the labrum in the hip.
Certain terminology will be used in the following description for convenience in reference only, and will not be limiting. For example, the words “upwardly”, “downwardly”, “rightwardly” and “leftwardly” will refer to directions in the drawings to which reference is made. The words “inwardly” and “outwardly” will refer to directions toward and away from, respectively, the geometric center and designated parts of thereof. The word “distally” will refer to the direction towards the end of the arrangement located closest to the patient, and the word “proximally” will refer to the direction towards the end of the arrangement located remote from the patient. Said terminology will include the words specifically mentioned, derivatives thereof, and words of similar import.
Referring to
The inserter device 12 is defined by an elongate and rigid inserter shaft 16 having a distal end 17 which engages the suture anchor 11. The inserter device 12 is of a known construction and includes a handle (not shown) which defines the proximal end of inserter device 12, which handle may include a suitable gripping surface similar to a screwdriver for use when manipulating the arrangement 10 with the hand. One type of inserter shaft which may be utilized in accordance with the invention is disclosed in U.S. Patent Publication Nos. 2009-0234387 and 2009-0082807, the entireties of which are incorporated by reference herein. Inserter shaft 16 may also include a tubular sidewall 20 which defines a bore 21 extending throughout the longitudinal length of shaft 16. Alternatively, the inserter shaft 16 may be a solid cylindrical shaft.
The distal end 17 of the inserter shaft 16 mounts thereon a projection 25. In the illustrated embodiment, projection 25 is polygonal in configuration so as to engage with the proximal end of the suture anchor 11. In one embodiment, the projection 25 has a rectangular cross-section. Projection 25 defines therein a centrally-located bore 26 which communicates with bore 21 of inserter shaft 16. It will be appreciated that other configurations of projection 26 are within the scope of the instant invention.
Turning now to suture anchor 11 as shown in
The central bore 33 has a proximal bore portion 38 which extends from the proximal end 32 of the anchor body 30 to an annular end face or surface 39 of anchor body 30 located proximate of the distal end 31 and oriented transversely to the axis A, and an intermediate bore portion 41 which extends axially from end face 39 towards distal end 31 of anchor body 30 and has a lesser diameter than bore portion 38. Bore 33 additionally includes a distal bore portion 43 defined by an annular surface 44 of anchor body 30, which surface 44 faces distally and is oriented transversely to axis A, and a further annular surface 45 oriented transversely to surface 44. In the illustrated embodiment surface 45 is oriented generally parallel to axis A and perpendicular to surface 44. Distal bore portion 43 opens distally through opening 36. Proximal bore portion 38 has a cross-sectional profile which matches the external configuration of the projection 25 of the inserter device 12. Further, the projection 25 is of a length to allow for full-length insertion into proximal bore portion 38 of bore 33 of the suture anchor body 30, and in the illustrated embodiment has a rectangular profile. The projection 25 can also have other profiles, such as hexagonal, oval, or star-shaped, and remain within the scope of the invention.
A pair of passages 50 and 51 extend transversely relative to the longitudinal axis A of the anchor 11, from the intermediate bore portion 41 of the bore 33 outwardly to the exterior of the anchor body 30. The passages 50 and 51 open outwardly into a circumferential groove 52 defined in the exterior surface of the anchor body 30, which groove 52 extends around the entire circumference thereof. In the illustrated embodiment, passages 50 and 51 open outwardly at diametrically opposite positions (i.e. about 180 degrees from one another) on the exterior surface of anchor body 30.
As best shown in
As mentioned above, suture anchor 11 carries thereon the suture engaging structure 14, which effectively serves as an attachment point for the working or repair sutures 13. In the illustrated embodiment, the suture engaging structure 14 is defined by suture material which is fixed to the anchor body 30. Specifically, and with reference to
Knot 84 and the diameter of intermediate bore portion 41 are of a size such that knot 84 substantially seats within distal bore portion 43, and surface or shoulder 44 effectively prevents movement of the knot 84 in the proximal direction through bore portion 38. In this regard, the knot 84 may be of a size which causes same to project outwardly somewhat from distal end 31 of anchor body 30, or may be in its entirety located completely within distal bore portion 36. The suture material thus forms a closed loop 86 having an interior section 87 (
One method of assembling the suture anchor 11 onto the inserter device 12 is as follows. The working suture 13 is loaded into inserter device 12, and free ends of two separate working sutures 13 (only one of which is shown in
The bore 38 which opens at the proximal end of anchor 11 is circumferentially or rotationally aligned with the projection 25 of inserter device 12 at the distal end 17 of inserter shaft 16, and the projection 25 is inserted into the proximal bore portion 38 of the suture anchor 11 until the projection 25 extends the full depth of the bore portion 38 to end face 39 of anchor body 30. The projection 25 thereby fully supports the length of the suture anchor 11, and increases the bearing surface between the projection 25 and the central bore 33 of the suture anchor 11. A given force is necessary to drive the suture anchor 11 into bone, and the increased bearing surface between the projection 25 and the suture anchor 11 distributes this force over a greater area, thereby diminishing the shearing force exerted on the material of the anchor body 30. The projection 25 further provides full length support of the hollow suture anchor 11 to prevent its collapse during insertion into bone. In the illustrated embodiment, the anchor 11 is not self-tapping, and thus requires a pilot hole be prepared in the bone before insertion. The free ends of the working sutures 13 located adjacent the handle of the inserter device 12 are then pulled in a proximal direction so as to tension the working sutures 13 and are then secured to the inserter device 12 to maintain the sutures 13 in a fixed position relative to inserter device 12.
It will be appreciated that suture loop 86 may be defined by a single strand of suture material, double or triple strands. In this regard, it may be desirable to use a single strand of suture material to form loop 86 if such material has sufficient strength, so as to simplify assembly, minimize materials, and reduce the volume of suture material within anchor body 30. Also, it may be desirable to use triple strands if the suture material utilized has a smaller diameter but is not of sufficient strength such that additional strands are necessary.
The suture anchor 11 is intended for implanting within hard tissue, such as bone 100. One method of implanting anchor 11 will be described with reference to
As shown in
The arrangement as discussed above includes the projection 25 on the distal end 17 of inserter device 12 which cooperates with the proximally-opening bore 38 of the suture anchor 11. It will be appreciated that this configuration could be reversed, for example, the suture anchor 11 could include a projection or external drive head which engages within a corresponding recess formed in the distal end 17 of the inserter device 12. However, forming the anchor 11 with an internal construction for allowing cooperation with the inserter device 12 is believed advantageous as compared to conventional anchors which include externally projecting drive heads at their proximal ends. In this regard, configuring the anchor in this manner allows same to be made smaller, so as to cause less trauma to the patient, and also allows the anchor to be provided with a greater thread length within the available anchor length, and thus is believed to result in a better engagement of the anchor within the bone.
As shown in
The suture anchor 11 according to the invention may be constructed of any suitable bio-absorbable material or non-absorbable material. In the preferred embodiment of the invention, the anchor 11 is constructed of bio-absorbable material. An example of a bio-absorbable material which may be utilized is BIOSTEON® (HA/PLLA), which is an absorbable polymer manufactured by Biocomposites Ltd. PLLA, which is a bio-absorbable plastic, may also be utilized. Alternatively, the anchor may be constructed of non-absorbable plastic, such as PEEK, or non-absorbable metal, such as titanium. It will be appreciated that other types of materials may be utilized in accordance with the invention, and the above are presented only as examples.
The suture anchor 11 may have a length dimension of about 10.8 mm, and may have an outside diameter of about 4.5mm, 5.5mm or 6.5mm. These dimensions are presented only as an example of relative dimensions of anchor 11, and are not intended to be limiting.
The inserter device 12 discussed above includes projection 25 at distal end 17 thereof. The shaft 16 and projection 25 of the inserter device 12 include centrally located bores 21 and 26 through which working sutures 13 are passed, as described above. In the alternative, suture anchor arrangements are known which integrate a suture/needle combination. The common curved needle configuration precludes passage of the suture through a cannulated inserter device, such as device 12. Therefore, a non-cannulated inserter or a partially cannulated inserter (not shown) in such an application would be compatible for use with the suture anchor 11, with the working suture 13 passing over the exterior surface of the inserter device.
Although a particular preferred embodiment has been disclosed in detail for illustrative purposes, it will be recognized that variations or modifications of the disclosed apparatus, including the rearrangement of parts, lie within the scope of the present invention.
Number | Name | Date | Kind |
---|---|---|---|
146023 | Russell | Dec 1873 | A |
197933 | Harvey | Dec 1877 | A |
2570465 | Lundholm | Oct 1951 | A |
3233500 | DeVellier | Feb 1966 | A |
3997138 | Crock et al. | Dec 1976 | A |
4175555 | Herbert | Nov 1979 | A |
4340184 | Poss | Jul 1982 | A |
4507817 | Staffeld | Apr 1985 | A |
4537185 | Stednitz | Aug 1985 | A |
4632100 | Somers et al. | Dec 1986 | A |
4640271 | Lower | Feb 1987 | A |
4738255 | Goble et al. | Apr 1988 | A |
4741330 | Hayhurst | May 1988 | A |
4854311 | Steffee | Aug 1989 | A |
4863383 | Grafelmann | Sep 1989 | A |
4870957 | Goble et al. | Oct 1989 | A |
5037422 | Hayhurst et al. | Aug 1991 | A |
5047030 | Draenert | Sep 1991 | A |
5100417 | Cerier et al. | Mar 1992 | A |
5156616 | Meadows et al. | Oct 1992 | A |
5224946 | Hayhurst et al. | Jul 1993 | A |
5258016 | DiPoto et al. | Nov 1993 | A |
5370662 | Stone et al. | Dec 1994 | A |
5417533 | Lasner | May 1995 | A |
5456685 | Huebner | Oct 1995 | A |
5472452 | Trott | Dec 1995 | A |
5549633 | Evans et al. | Aug 1996 | A |
5571139 | Jenkins, Jr. | Nov 1996 | A |
5573548 | Nazre et al. | Nov 1996 | A |
5584836 | Ballintyn et al. | Dec 1996 | A |
5601557 | Hayhurst | Feb 1997 | A |
5601558 | Torrie et al. | Feb 1997 | A |
5628766 | Johnson | May 1997 | A |
5643320 | Lower et al. | Jul 1997 | A |
5647874 | Hayhurst | Jul 1997 | A |
D385352 | Bales et al. | Oct 1997 | S |
5690676 | DiPoto et al. | Nov 1997 | A |
5709708 | Thal | Jan 1998 | A |
5725529 | Nicholson et al. | Mar 1998 | A |
5733307 | Dinsdale | Mar 1998 | A |
5814070 | Borzone | Sep 1998 | A |
5871486 | Huebner et al. | Feb 1999 | A |
5891146 | Simon et al. | Apr 1999 | A |
5891168 | Thal | Apr 1999 | A |
5893880 | Egan et al. | Apr 1999 | A |
5911721 | Nicholson et al. | Jun 1999 | A |
5941882 | Jammet et al. | Aug 1999 | A |
5951560 | Simon et al. | Sep 1999 | A |
5957953 | DiPoto et al. | Sep 1999 | A |
5964764 | West, Jr. et al. | Oct 1999 | A |
5964768 | Huebner | Oct 1999 | A |
5964783 | Grafton et al. | Oct 1999 | A |
6030162 | Huebner | Feb 2000 | A |
6079921 | Gauthier et al. | Jun 2000 | A |
6096060 | Fitts et al. | Aug 2000 | A |
6117162 | Schmieding et al. | Sep 2000 | A |
6139565 | Stone et al. | Oct 2000 | A |
6214031 | Schmieding et al. | Apr 2001 | B1 |
6264677 | Simon et al. | Jul 2001 | B1 |
6299615 | Huebner | Oct 2001 | B1 |
6436124 | Anderson et al. | Aug 2002 | B1 |
6468277 | Justin et al. | Oct 2002 | B1 |
6511499 | Schmieding et al. | Jan 2003 | B2 |
6517564 | Grafton et al. | Feb 2003 | B1 |
6517578 | Hein | Feb 2003 | B2 |
6569188 | Grafton et al. | May 2003 | B2 |
6610080 | Morgan | Aug 2003 | B2 |
6616665 | Grafton et al. | Sep 2003 | B2 |
6635074 | Bartlett | Oct 2003 | B2 |
6641597 | Burkhart et al. | Nov 2003 | B2 |
6648892 | Martello | Nov 2003 | B2 |
6652563 | Dreyfuss | Nov 2003 | B2 |
6685728 | Sinnott et al. | Feb 2004 | B2 |
6726707 | Pedlick et al. | Apr 2004 | B2 |
6730092 | Songer | May 2004 | B2 |
6773436 | Donnelly et al. | Aug 2004 | B2 |
6840953 | Martinek | Jan 2005 | B2 |
6887259 | Lizardi | May 2005 | B2 |
6916333 | Schmieding et al. | Jul 2005 | B2 |
6923824 | Morgan et al. | Aug 2005 | B2 |
7081126 | McDevitt et al. | Jul 2006 | B2 |
7090675 | Songer | Aug 2006 | B2 |
7163540 | Martello | Jan 2007 | B2 |
7189251 | Kay | Mar 2007 | B2 |
7195634 | Schmieding et al. | Mar 2007 | B2 |
7217279 | Reese | May 2007 | B2 |
7226469 | Benavitz et al. | Jun 2007 | B2 |
7232455 | Pedlick et al. | Jun 2007 | B2 |
7309337 | Colleran | Dec 2007 | B2 |
7322978 | West, Jr. | Jan 2008 | B2 |
7500983 | Kaiser et al. | Mar 2009 | B1 |
7530990 | Perriello et al. | May 2009 | B2 |
7588587 | Barbieri et al. | Sep 2009 | B2 |
7611521 | Lubbers et al. | Nov 2009 | B2 |
7678134 | Schmieding et al. | Mar 2010 | B2 |
7695495 | Dreyfuss | Apr 2010 | B2 |
7780701 | Meridew et al. | Aug 2010 | B1 |
7828820 | Stone et al. | Nov 2010 | B2 |
7846180 | Cerier | Dec 2010 | B2 |
7862585 | Li et al. | Jan 2011 | B2 |
7883528 | Grafton et al. | Feb 2011 | B2 |
7883529 | Sinnott et al. | Feb 2011 | B2 |
7909851 | Stone et al. | Mar 2011 | B2 |
8029536 | Sorenson | Oct 2011 | B2 |
8114127 | West, Jr. | Feb 2012 | B2 |
8114128 | Cauldwell et al. | Feb 2012 | B2 |
8197511 | Miller et al. | Jun 2012 | B2 |
8439946 | Miller et al. | May 2013 | B2 |
8545536 | Mayer et al. | Oct 2013 | B2 |
20020173822 | Justin et al. | Nov 2002 | A1 |
20030171778 | Lizardi | Sep 2003 | A1 |
20040093030 | Cox et al. | May 2004 | A1 |
20040106950 | Grafton et al. | Jun 2004 | A1 |
20040153103 | Schwartz | Aug 2004 | A1 |
20040167576 | Pedlick et al. | Aug 2004 | A1 |
20040172062 | Burkhart | Sep 2004 | A1 |
20040254580 | Boock et al. | Dec 2004 | A1 |
20050075636 | Gotzen | Apr 2005 | A1 |
20050222618 | Dreyfuss et al. | Oct 2005 | A1 |
20050222619 | Dreyfuss et al. | Oct 2005 | A1 |
20050245932 | Fanton et al. | Nov 2005 | A1 |
20050267479 | Morgan et al. | Dec 2005 | A1 |
20060161159 | Dreyfuss et al. | Jul 2006 | A1 |
20060189993 | Stone | Aug 2006 | A1 |
20060190042 | Stone et al. | Aug 2006 | A1 |
20060293675 | Li et al. | Dec 2006 | A1 |
20070005069 | Contiliano et al. | Jan 2007 | A1 |
20070032792 | Collin | Feb 2007 | A1 |
20070060922 | Dreyfuss | Mar 2007 | A1 |
20070073299 | Dreyfuss et al. | Mar 2007 | A1 |
20070142836 | Schmieding et al. | Jun 2007 | A1 |
20070142837 | Dreyfuss | Jun 2007 | A1 |
20070173845 | Kim | Jul 2007 | A1 |
20070185494 | Reese | Aug 2007 | A1 |
20070219557 | Bourque et al. | Sep 2007 | A1 |
20070219558 | Deutsch | Sep 2007 | A1 |
20080009904 | Bourque et al. | Jan 2008 | A1 |
20080167660 | Moreau et al. | Jul 2008 | A1 |
20080306510 | Stchur | Dec 2008 | A1 |
20090082807 | Miller et al. | Mar 2009 | A1 |
20090234387 | Miller et al. | Sep 2009 | A1 |
20100094355 | Trenhaile | Apr 2010 | A1 |
20100100127 | Trenhaile | Apr 2010 | A1 |
20100152773 | Lunn | Jun 2010 | A1 |
20110054526 | Stone | Mar 2011 | A1 |
20110224727 | Housman | Sep 2011 | A1 |
20120095506 | Mayer et al. | Apr 2012 | A1 |
20120197296 | Mayer et al. | Aug 2012 | A1 |
Number | Date | Country |
---|---|---|
0784963 | Nov 2002 | AU |
2 386 621 | Nov 2002 | CA |
1 260 182 | Nov 2002 | EP |
1 300 115 | Apr 2003 | EP |
1 486 171 | Dec 2004 | EP |
1 530 951 | May 2005 | EP |
1 762 187 | Mar 2007 | EP |
1 797 827 | Jun 2007 | EP |
2 254 298 | Nov 1975 | FR |
02 588 332 | Apr 1987 | FR |
2003010198 | Jan 2003 | JP |
01034734 | Aug 1983 | SU |
Number | Date | Country | |
---|---|---|---|
20130253581 A1 | Sep 2013 | US |