The present invention relates to methods and instruments for fixation of sutures and tissue to bone.
When soft tissue tears away from bone, reattachment becomes necessary. Various devices, including sutures, screws, staples, wedges, anchors and plugs have been used in the prior art to secure soft tissue to bone. Surgical methods utilizing suture anchors alone are disadvantageous for reattachment of large areas of detached tissue because they often do not allow good tissue to bone contact.
Reattachment of soft tissue to bone typically requires the surgeon to pass suture material through selected tissue, form a plurality of surgical knots extracorporeally and then move the knots into position adjacent the desired tissue to be sutured. In such procedures, the surgeon must manually tie the knots on the suture strands after the suture is threaded through the selected tissues to be sutured. Knot tying during surgery, particularly arthroscopic surgery, is tedious and time-consuming. There is also a tendency for the knots to deform or collapse as the surgeon manually forces the knots down into the proper position. Also, the suture knots often are exposed to abrasion or cutting by sharp or rough areas along the walls of the bone canal into which anchors are typically inserted to provide fixation of tendon to bone.
Accordingly, a need exists for an improved method for attaching soft tissue to bone which does not require multiple suture knots and which allows the tendon to remain securely in place until the ligaments naturally attach to bone. A need also exists for such a knotless method of attaching tissue to bone which employs an implant with a fenestrated configuration that promotes healing of tissue.
The instruments and methods of the present invention overcome the disadvantages of the prior art, such as those noted above, by providing an implant at the distal end of a driver that securely engages and locks into a cannulated interference plug or screw. The implant receives a strand attached to a graft.
In one embodiment of the invention, the strand is passed through the graft at desired points. A cannulated plug or screw is pre-loaded onto a driver provided with a swivel lock twist-in anchor at its distal end. The strand attached to the graft is passed through an aperture of the implant, which is located at the distal end of the driver. The distal end of the driver together with the implant is inserted directly into the bone. The driver may be rotated (in a clockwise direction, for example) to advance a screw over the anchor to complete insertion.
Other features and advantages of the present invention will become apparent from the following description of exemplary embodiments of the invention described with reference to the accompanying drawings.
The present invention provides apparatus and methods for knotless tissue fixation using a swivel anchor device.
First, and as illustrated in
Subsequent to the formation of the pilot holes, and as shown in
Referring to
The swivel anchor and instruments of the present invention are now described in greater detail. As shown in
During installation of the knotless anchor having a swiveling implant 30, the screw 42 is first inserted onto cannulated rod 20 of the driver 68. As shown in
The knotless fixation device of the present invention advantageously minimizes or eliminates the need to tie knots. The use of such a swivel anchor also provides secure fixation of the suture construct—the secure suture construct results from the suture being pushed into a hole and held tightly by an anchors.
In the preferred embodiment of the present invention, as mentioned above, suture tape is used with the swivel anchor to fix tissue to bone. However, the swivel anchor of the present invention can be used with any type of flexible material or suture. In another preferred embodiment, an allograft or biological component may be used instead of suture or tape. The allograft or biological component may be comprised of tendon or pericardium, for example, which provides improved tissue repair. In yet additional embodiments, any combination of suture, suture tape, and allograft or biological component may be employed, depending on the characteristics of the specific surgical repair and/or as desired.
As illustrated in
Preferably, the fixation device 600 is preloaded on the driver 68. As described above with reference to the three exemplary embodiments, the fixation device 600 is advanced into the bone socket by holding the thumb pad 50 as the driver handle 22 is turned clockwise. When the fixation device 600 is fully seated, the shaft of the anchor implant 30 or the swivel implant 500 is fully engaged by the fixation device 600 to optimize the stability of the swivel anchor construct (composed of swivel anchor or implant 30, 500 and fixation device 600).
As illustrated in
The fixation device 600 of the present invention may be formed of a biocompatible and/or biosorbable material. Preferably, screw 600 is formed of a bioabsorbable material, such as poly-(L-lactic acid) (PLLA), poly-(D,L-lactide), and poly glycolic acid (PGA), for example, or other bioabsorbable, non-metallic materials, which may be especially tailored for hardness, tensile strength and compressive strength. Alternatively, fixation device 600 may be formed of titanium, titanium alloy, stainless steel or stainless steel alloy. Other biocompatible materials which could be used include plastics, allograft bone and inert bone substitute materials.
A growth material may be advanced through the cannulated driver and into the screw 600 by employing a plunger, for example. As the driver is pulled out, the plunger pushes the flow material through the cannulation of the driver and into the body of the screw 600. The growth material will subsequently harden to allow better fixation of the interference screw 600 against the bone and the shaft of the swivel anchor 30 or swivel implant 500.
The growth material may be any solid, semi-solid, viscous, flowable, gel or elastic composition or mixture that allows its easy manipulation and insertion into the body 612 of the interference screw 600. The growth material may contain growth factors such as autogenous growth factors, for example platelet-rich plasma (PRP), optionally in combination with hyaluronic acid (HY acid) and/or with a coagulant such as thrombin.
The term “growth factor” as used in the present application is intended to include all factors, such as proteinaceous factors, for example, which play a role in the induction or conduction of growth of bone, ligaments, cartilage or other tissues associated with bone or joints. In particular, these growth factors include bFGF, aFGF, EGF (epidermal growth factor), PDGF (platelet-derived growth factor), IGF (insulin-like growth factor), TGF-β. I through III, including the TGF-β. superfamily (BMP-1 through 12, GDF 1 through 12, dpp, 60A, BIP, OF).
Optionally, the growth material may comprise additional osteoconductive bone adhesives, calcium carbonate, fatty acids, lubricants, antiseptic chemicals and/or antibiotics. In this case, other solution excipients such as buffer salts, sugars, anti-oxidants and preservatives to maintain the bioactivity of the growth material and a proper pH of the growth material may be also employed. The additional lubricants and/or the antiseptic and/or the antibiotic will typically be present in the growth material in a predetermined concentration range, which will be dependent upon the particular bone site and application, as well as the specific activity of the antiseptic and/or the antibiotic.
Although the present invention has been described in relation to particular embodiments thereof, many other variations and modifications and other uses will become apparent to those skilled in the art. It is preferred, therefore, that the present invention be limited not by the specific disclosure herein.
This is a continuation of application Ser. No. 15/976,157, filed May 10, 2018, which is a continuation of application Ser. No. 14/707,861, filed on May 8, 2015, now U.S. Pat. No. 10,881,388, which is a continuation of application Ser. No. 13/403,366, filed Feb. 23, 2012, now abandoned, which is a continuation of application Ser. No. 12/418,391, filed on Apr. 3, 2009, now abandoned, which is a continuation-in-part of application Ser. No. 12/368,946, filed on Feb. 10, 2009, now abandoned, which is: (i) a continuation-in-part of application Ser. No. 12/043,008, filed on Mar. 5, 2008, now abandoned, which in turn is a continuation-in-part of application Ser. No. 11/802,057, filed on May 18, 2007, now U.S. Pat. No. 9,005,246, which claims the benefit of Provisional Application No. 60/801,097, filed on May 18, 2006; and (2) a continuation-in-part of application Ser. No. 11/392,798, filed on Mar. 30, 2006, now U.S. Pat. No. 7,803,173, which claims the benefit of Provisional Application No. 60/666,518, filed on Mar. 30, 2005. The entire disclosures of all of these priority applications are incorporated herein by reference.
Number | Name | Date | Kind |
---|---|---|---|
4484570 | Sutter et al. | Nov 1984 | A |
4632100 | Somers et al. | Dec 1986 | A |
4870957 | Goble | Oct 1989 | A |
5084050 | Draenert | Jan 1992 | A |
5129904 | Illi | Jul 1992 | A |
5152790 | Rosenberg et al. | Oct 1992 | A |
5236445 | Hayhurst | Aug 1993 | A |
5249899 | Wilson | Oct 1993 | A |
5258016 | DiPoto | Nov 1993 | A |
5368595 | Lewis | Nov 1994 | A |
5423860 | Lizardi et al. | Jun 1995 | A |
5500000 | Feagin et al. | Mar 1996 | A |
5540718 | Bartlett | Jul 1996 | A |
5545180 | Le et al. | Aug 1996 | A |
5584835 | Greenfield | Dec 1996 | A |
5827285 | Bramlet | Oct 1998 | A |
5860973 | Michelson | Jan 1999 | A |
5891168 | Thal | Apr 1999 | A |
5935129 | McDevitt | Aug 1999 | A |
5968047 | Reed | Oct 1999 | A |
6045574 | Thal | Apr 2000 | A |
6048343 | Mathis et al. | Apr 2000 | A |
6143017 | Thal | Nov 2000 | A |
6214007 | Anderson | Apr 2001 | B1 |
6355043 | Adam | Mar 2002 | B1 |
6368326 | Dakin | Apr 2002 | B1 |
6517542 | Papay et al. | Feb 2003 | B1 |
6527794 | McDevitt et al. | Mar 2003 | B1 |
6544281 | ElAttrache et al. | Apr 2003 | B2 |
6554281 | Flannery | Apr 2003 | B2 |
6589245 | Weiler et al. | Jul 2003 | B1 |
6840953 | Martinek | Jan 2005 | B2 |
6863671 | Strobel et al. | Mar 2005 | B1 |
6939135 | Sapian | Sep 2005 | B2 |
7037324 | Martinek | May 2006 | B2 |
7083637 | Tannhauser | Aug 2006 | B1 |
7083647 | Sklar et al. | Aug 2006 | B1 |
7261716 | Strobel et al. | Aug 2007 | B2 |
7300439 | May | Nov 2007 | B2 |
7329272 | Burkhart et al. | Feb 2008 | B2 |
7572283 | Meridew | Aug 2009 | B1 |
7585311 | Green et al. | Sep 2009 | B2 |
7588587 | Barbieri et al. | Sep 2009 | B2 |
7645293 | Martinek et al. | Jan 2010 | B2 |
7717947 | Wilberg et al. | May 2010 | B1 |
7803173 | Burkhart et al. | Sep 2010 | B2 |
7976565 | Meridew | Jul 2011 | B1 |
7981140 | Burkhart | Jul 2011 | B2 |
7993369 | Dreyfuss | Aug 2011 | B2 |
8012174 | ElAttrache et al. | Sep 2011 | B2 |
8100942 | Green | Jan 2012 | B1 |
8109969 | Green | Feb 2012 | B1 |
8114127 | West, Jr. | Feb 2012 | B2 |
8663279 | Burkhart et al. | Mar 2014 | B2 |
9005246 | Burkhart et al. | Apr 2015 | B2 |
10881388 | Burkhart | Jan 2021 | B2 |
11571200 | Burkhart | Feb 2023 | B2 |
20020013608 | ElAttrache | Jan 2002 | A1 |
20020147463 | Martinek | Oct 2002 | A1 |
20020156476 | Wilford | Oct 2002 | A1 |
20030065332 | TenHuisen | Apr 2003 | A1 |
20030125739 | Bagga et al. | Jul 2003 | A1 |
20030153947 | Koseki | Aug 2003 | A1 |
20040093030 | Cox et al. | May 2004 | A1 |
20040093031 | Burkhart et al. | May 2004 | A1 |
20040138706 | Abrams | Jul 2004 | A1 |
20040193217 | Lubbers et al. | Sep 2004 | A1 |
20040225292 | Sasso et al. | Nov 2004 | A1 |
20050089552 | Altman et al. | Apr 2005 | A1 |
20050119698 | Martinek | Jun 2005 | A1 |
20060004364 | Green et al. | Jan 2006 | A1 |
20060074422 | Story et al. | Apr 2006 | A1 |
20060079904 | Thal | Apr 2006 | A1 |
20060100630 | West, Jr. | May 2006 | A1 |
20060235413 | Denham et al. | Oct 2006 | A1 |
20060247642 | Stone et al. | Nov 2006 | A1 |
20060259076 | Burkhart et al. | Nov 2006 | A1 |
20070038221 | Fine et al. | Feb 2007 | A1 |
20070060922 | Dreyfuss | Mar 2007 | A1 |
20070135843 | Burkhart | Jun 2007 | A1 |
20070191849 | ElAttrache | Aug 2007 | A1 |
20070225719 | Stone et al. | Sep 2007 | A1 |
20080004659 | Burkhart et al. | Jan 2008 | A1 |
20080009904 | Bourque et al. | Jan 2008 | A1 |
20080154314 | McDevitt | Jun 2008 | A1 |
20080208253 | Dreyfuss et al. | Aug 2008 | A1 |
20080215091 | Dreyfuss | Sep 2008 | A1 |
20080275431 | Stone et al. | Nov 2008 | A1 |
20080281325 | Stone et al. | Nov 2008 | A1 |
20090192546 | Schmieding et al. | Jul 2009 | A1 |
20090281581 | Berg | Nov 2009 | A1 |
20090287259 | Trenhaile | Nov 2009 | A1 |
20100248888 | Hamperl | Sep 2010 | A1 |
20100249854 | Thomas | Sep 2010 | A1 |
20100331896 | Le Couedic et al. | Dec 2010 | A1 |
20110106252 | Barwood | May 2011 | A1 |
20110313455 | ElAttrache et al. | Dec 2011 | A1 |
20120022588 | Berg | Jan 2012 | A1 |
20120165868 | Burkhart et al. | Jun 2012 | A1 |
20130035721 | Brunelle | Feb 2013 | A1 |
20130158597 | Hernandez | Jun 2013 | A1 |
20130345750 | Sullivan | Dec 2013 | A1 |
20140364906 | Palese | Dec 2014 | A1 |
20170209139 | Burkhart | Jul 2017 | A1 |
Number | Date | Country |
---|---|---|
1 857 054 | Nov 2007 | EP |
WO 0221999 | Mar 2002 | WO |
WO 2006060035 | Jun 2006 | WO |
WO 2006099109 | Sep 2006 | WO |
Entry |
---|
Petition for Inter Partes Review (IPR) of U.S. Pat. No. 9,179,907 (Case No. IPR 2017-00275). |
Claim Construction Memorandum and Order, Arthrex, Inc. v. Smith & Nephew, Inc et al., Case No. 2:15-cv-01047 (RSP) (E.D. Texas Aug. 10, 2016). |
Letter from Celia M. Witten, M.D., to Edward F. Kent, Re: K974345 (Feb. 13, 1998). |
Letter from Celia M. Witten, M.D., to Mark Ritchart, Re: K012125 (Sep. 17, 2001). |
Declaration of Dr. David R. McAllister. |
Aaron T. Hecker et al., “Pull-out Strength of Suture Anchors for Rotator Cuff and Bankart Lesion Repairs,” American Journal of Sports Medicine, vol. 21, No. 6, 874-879 (1993). |
F. Alan Barber et al., “Suture Anchor Failure Strength—An In Vivo Study,” Arthroscopy: the Journal of Arthroscopic and Related Surgery, vol. 9, No. 6, 647-652 at 647 (1993). |
F. Alan Barber et al., “Suture Anchor Strength Revisited,” Arthroscopy: the Journal of Arthroscopic and Related Surgery, vol. 12, No. 1, 32-38 (1996). |
F. Alan Barber et al., “Suture Anchors—Update 1999,” Arthroscopy: the Journal of Arthroscopic and Related Surgery, vol. 15, No. 5, 719-725 (1999). |
Number | Date | Country | |
---|---|---|---|
20230048745 A1 | Feb 2023 | US |
Number | Date | Country | |
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60801097 | May 2006 | US | |
60666518 | Mar 2005 | US |
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Child | 14707861 | US | |
Parent | 12418391 | Apr 2009 | US |
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Child | 12043008 | US | |
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