The present invention includes surgical instruments that are configured to secure tissue and pass a needle through the secured tissue where the needle is equipped to deliver a suture through the tissue. Typically such suture passing instruments are used for tissue repair procedures.
Suturing devices are commonly used for open and endoscopic surgical procedures that require the use of a suture to ligate, join, re-attach tendon to bone, or otherwise secure adjoining tissue. Many such suturing devices grasp the tissue with a jaw assembly and pass the suture through the tissue using a needle that undergoes deformation either when loaded into the device, or upon exiting the device. Many of these devices rely on super-elastic needles that must be replaced.
However, the use of needles that undergo deformation can present problems in that the needles often fail by breaking and must be replaced. On many occasions, the needle fails during the surgical procedure and must be removed from inside a patient, which causes added difficulty, time and cost to the procedure. The cost of replacement needles, especially those fabricated from a superplastic material, can be excessive.
Accordingly, there is a need for a suture passing instrument that may be operated in the manner similar to conventional suture passing devices but employ a pre-curved needle that does not experience deformation within the suturing device or during deployment of the suturing device. Elimination of the deformation of the needle can allow for a device with a fixed needle, that can optionally be reusable, which can result in a cost savings.
In view of the above, there remains a need to provide an improved suture passing device.
The illustrations and variations described herein are meant to provide examples of the methods and devices of the invention. It is contemplated that combinations of aspects of specific embodiments or combinations of the specific embodiments themselves are within the scope of this disclosure.
The present disclosure includes suture passing instruments having a curved needle that does not experience deformation within the suture passing device and during deployment. Such a suturing device can provide a fixed needle rather than a disposable or replaceable needle.
In one example the suture passing device comprises a shaft having a far portion and a near portion; a handle assembly located at the near end of the shaft and comprising a needle actuator moveably coupled to a handle portion, a trigger lever moveably coupled to the handle portion, the handle portion coupled to the near end of the shaft; a jaw assembly comprising an actuating jaw moveably coupled to a fixed jaw, the fixed jaw located at the far portion of the shaft, where actuation of the trigger lever moves the actuating jaw relative to the fixed jaw to open and close the jaw assembly; a curved needle nested within the fixed jaw and slidable within a curved track of the fixed jaw, where a curvature of the curved needle and a curvature of the track are matched to permit movement of the curved needle through the curved track in without being deformed, the curved needle having a suture carrying slot at a distal portion allowing for loading of a suture external to the shaft; and a needle linkage having a first end coupled to a proximal section of the curved needle at a pivot joint and a second end coupled to the needle actuator, such that movement of the needle actuator advances the needle linkage in a forward direction to move the curved needle through the curved track and out through a top of the jaw assembly without deformation of the curved needle, where the pivot joint permits axial movement of the needle linkage without deformation.
The suture passing device can also include a variation the fixed jaw comprises an opening at a distal end exposing the suture carrying slot for loading of the suture external to the shaft. This slot may be through the center or side of the lower fixed jaw.
In another example, the suture passing device of can comprise an actuating jaw having an opening at a distal end to further expose the suture carrying slot when the jaw assembly is closed.
In another variation, the suture passing device further comprises a jaw linkage located within the shaft and having a first end and a second end, the first end of the jaw linkage engaged with the actuating jaw, the second end of the jaw linkage engaged with the trigger lever, such that movement of the trigger lever relative to the handle portion causes movement of the jaw linkage causing movement of the actuating jaw relative to the fixed jaw.
Variations of the suture passing device can include a trigger lever that comprises a first actuator portion pivotally coupled to the handle portion and a second locking portion pivotally coupled to the first actuator portion, where the second locking portion comprises a trigger locking surface moveably engaged with a handle locking surface, such that when engaged, the trigger locking surface and handle locking surface locks the trigger lever in place to lock the jaw assembly in place.
In an additional variation, the suture passing device can include a second locking portion that is spring biased against the first actuator portion, and where relative movement between the first actuator portion and the second locking portion causes disengagement of the trigger locking surface from the handle locking surface to release the jaw assembly. In additional variations, the device can be used with or without a ratchet lock configuration.
In an additional variation, the pivot joint comprises a bore in the proximal section of the curved needle and a slot in the first end of the needle linkage. Alternatively, variations of the device can comprise a curved needle and needle linkage that are continuous and the pivot joint comprises a living hinge between the curved needle and needle linkage.
In another variation, the suture passing device described herein can include a needle actuator that is spring biased against the handle portion to cause the curved needle to remain within the curved track until a force is applied to the needle actuator. Variations of the device can also include a locking mechanism to prevent motion of the needle in the locked position.
In additional variations, the trigger lever can be spring biased against the handle portion to cause the jaw assembly to remain open until a force is applied to the trigger lever.
Variations of the suture passing devices include a needle actuator that is moveably coupled to the handle portion at an end of the handle portion opposite to the shaft.
Each of the following figures diagrammatically illustrates aspects and variation to better understand the invention. Variation of the invention from the aspects shown in the figures is contemplated.
The handle assembly 104 shown in
The actuating jaw 154 also includes a channel 158 that allows for delivery of the needle and suture (not shown in
The fixed jaw 152 includes a suture channel 166 that permits loading of the suture onto the needle 162. In the example show in
As noted above, a variation of the device includes a non-deformable, high strength, and/or rigid needle fabricated from a hardened material. Since the needle is pre-curved and does not undergo deformation when in the device, the hardened needle can be driven through thick, fibrous, calcified, or other difficult tissue that would cause deformation of the conventional type of needles (such as shape memory or Nitinol materials) that are often used in suture passing devices. In one example, the needle material comprises a hardened stainless steel alloy with a UTS (ultimate tensile strength of 230,000 PSI. In such a case, the stainless steel is handed and then is shaped through an electrical discharge machining (EDM) process that cuts or forms the hardened material into a naturally curved state that remains in a permanently non-deformed curved state. This material, combined with a larger cross sectional surface (such as the rectangular cross-sectional profile shown in the figures) provides the ability of the device to apply significant force to the needle when compared to conventional deformable needles (e.g., Nitinol needles). In one example, the pre-curved needle was fabricated from a custom 455 ® Stainless steel with a hardness of H900 provided by Carpenter Technology Corporation (PA).
The pivot joint 180 coupling the needle 162 and the needle linkage 168 allows the needle to freely pivot relative to the needle linkage 168 as shown in
In some variations of the device 100 the first spring 136 is configured a lower spring constant (or is less stiff) than the second needle spring 138. This balancing of springs allow a user to position the device appropriately and then squeeze the trigger lever 108 while applying force on the needle actuator 110. Because the first spring 136 is less stiff than the second spring 138, the trigger lever 108 pivots at its coupling point and moves in direction 140 to drive the jaw linkage 120 and 124 towards the jaw assembly 150. A variation of the device 100 can include a trigger locking surface 128 that engages a handle 130 locking surface 130 coupled to a handle portion 106. Such surfaces can comprise a ratchet and pawl system or detent system. In the illustrated variation, and as discussed below, the trigger locking surface 128 can be spring biased to remain against the handle locking portion 130 such that movement of trigger in direction 140 is prevented from reversing while the trigger locking surface 128 remains engaged with the handle locking surface 130.
Once the jaws close (as shown in
A number of embodiments of the invention have been described. Nevertheless, it will be understood that various modifications may be made without departing from the spirit and scope of the invention. Combination of the aspect of the variations discussed above as well combinations of the variations themselves are intended to be within the scope of this disclosure.
Various changes may be made to the invention described and equivalents (whether recited herein or not included for the sake of some brevity) may be substituted without departing from the true spirit and scope of the invention. Also, any optional feature of the inventive variations may be set forth and claimed independently, or in combination with any one or more of the features described herein. Accordingly, the invention contemplates combinations of various aspects of the embodiments or combinations of the embodiments themselves, where possible. Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “and,” “said,” and “the” include plural references unless the context clearly dictates otherwise.
This application is a continuation of U.S. patent application Ser. No. 15/261,521 filed Sep. 9, 2016, which is a continuation of U.S. patent application Ser. No. 15/072,243 filed Mar. 16, 2016 (now U.S. Pat. No. 9,439,647 issued Sep. 13, 2016), which is a non-provisional of U.S. Provisional Application No. 62/302,190 filed Mar. 2, 2016, the entirety of which is incorporated by reference.
| Number | Name | Date | Kind |
|---|---|---|---|
| 1822330 | Ainslie | Sep 1931 | A |
| 2748773 | Vacheresse | Jun 1956 | A |
| 3470875 | Johnson | Oct 1969 | A |
| 3807407 | Schweizer | Apr 1974 | A |
| 3842840 | Schweizer | Oct 1974 | A |
| 3901244 | Schweizer | Aug 1975 | A |
| 3946740 | Bassett | Mar 1976 | A |
| 4569131 | Falk et al. | Feb 1986 | A |
| 4890615 | Caspari et al. | Jan 1990 | A |
| 4923461 | Caspari et al. | May 1990 | A |
| 4957498 | Caspari et al. | Sep 1990 | A |
| 5176702 | Bales et al. | Jan 1993 | A |
| 5254126 | Filipi et al. | Oct 1993 | A |
| 5312422 | Trott | May 1994 | A |
| 5314424 | Nicholas | May 1994 | A |
| 5387227 | Grice | Feb 1995 | A |
| 5391174 | Weston | Feb 1995 | A |
| 5425743 | Nicholas | Jun 1995 | A |
| 5431666 | Sauer et al. | Jul 1995 | A |
| 5437681 | Meade | Aug 1995 | A |
| 5454823 | Richardson et al. | Oct 1995 | A |
| 5474565 | Trott | Dec 1995 | A |
| 5483952 | Aranyi | Jan 1996 | A |
| 5499998 | Meade | Mar 1996 | A |
| 5522820 | Caspari et al. | Jun 1996 | A |
| 5613977 | Weber et al. | Mar 1997 | A |
| 5626608 | Cuny et al. | May 1997 | A |
| 5676675 | Grice | Oct 1997 | A |
| 5690653 | Richardson et al. | Nov 1997 | A |
| 5730747 | Ek et al. | Mar 1998 | A |
| 5814054 | Kortenbach et al. | Sep 1998 | A |
| 5824009 | Fukuda et al. | Oct 1998 | A |
| 5980538 | Fuchs et al. | Nov 1999 | A |
| 6077286 | Cuschieri et al. | Jun 2000 | A |
| 6117158 | Measamer et al. | Sep 2000 | A |
| 6245079 | Nobles et al. | Jun 2001 | B1 |
| 6299624 | Cuschieri et al. | Oct 2001 | B1 |
| 6511487 | Oren et al. | Jan 2003 | B1 |
| 6527785 | Sancoff et al. | Mar 2003 | B2 |
| 6533795 | Tran et al. | Mar 2003 | B1 |
| 6638283 | Thal | Oct 2003 | B2 |
| 6770084 | Bain et al. | Aug 2004 | B1 |
| 6896686 | Weber | May 2005 | B2 |
| 6916332 | Adams | Jul 2005 | B2 |
| 6921408 | Sauer | Jul 2005 | B2 |
| 6984237 | Hatch et al. | Jan 2006 | B2 |
| 7004951 | Gibbens, III | Feb 2006 | B2 |
| 7011668 | Sancoff et al. | Mar 2006 | B2 |
| 7037315 | Sancoff et al. | May 2006 | B2 |
| D523554 | Weisel | Jun 2006 | S |
| 7063715 | Onuki et al. | Jun 2006 | B2 |
| D529173 | Weisel | Sep 2006 | S |
| 7112208 | Morris et al. | Sep 2006 | B2 |
| D530421 | Topper et al. | Oct 2006 | S |
| 7131978 | Sancoff et al. | Nov 2006 | B2 |
| 7131979 | DiCarlo et al. | Nov 2006 | B2 |
| 7131980 | Field et al. | Nov 2006 | B1 |
| 7166116 | Lizardi et al. | Jan 2007 | B2 |
| 7232448 | Battles et al. | Jun 2007 | B2 |
| 7338513 | Lee et al. | Mar 2008 | B2 |
| 7377926 | Topper et al. | May 2008 | B2 |
| 7381212 | Topper et al. | Jun 2008 | B2 |
| 7407505 | Sauer et al. | Aug 2008 | B2 |
| 7431188 | Marczyk | Oct 2008 | B1 |
| 7458966 | Frank et al. | Dec 2008 | B2 |
| 7543730 | Marczyk | Jun 2009 | B1 |
| 7565993 | Milliman et al. | Jul 2009 | B2 |
| 7572265 | Stone et al. | Aug 2009 | B2 |
| 7585305 | Dreyfuss | Sep 2009 | B2 |
| 7727256 | McGregor | Jun 2010 | B2 |
| 7879046 | Weinert et al. | Feb 2011 | B2 |
| 7879048 | Bain et al. | Feb 2011 | B2 |
| 7922744 | Morris et al. | Apr 2011 | B2 |
| 7935128 | Rioux et al. | May 2011 | B2 |
| 7938839 | DiFrancesco et al. | May 2011 | B2 |
| 7972344 | Murray et al. | Jul 2011 | B2 |
| 8123764 | Meade et al. | Feb 2012 | B2 |
| 8177796 | Akyuz et al. | May 2012 | B2 |
| 8460318 | Murray et al. | Jun 2013 | B2 |
| 8821518 | Saliman et al. | Sep 2014 | B2 |
| 8920441 | Saliman | Dec 2014 | B2 |
| 9173655 | Martin | Nov 2015 | B2 |
| 20020065526 | Oren et al. | May 2002 | A1 |
| 20020103493 | Thal | Aug 2002 | A1 |
| 20020138084 | Weber | Sep 2002 | A1 |
| 20020147456 | Diduch et al. | Oct 2002 | A1 |
| 20030083695 | Morris et al. | May 2003 | A1 |
| 20030220657 | Adams | Nov 2003 | A1 |
| 20030220659 | Schmieding et al. | Nov 2003 | A1 |
| 20030233106 | Dreyfuss | Dec 2003 | A1 |
| 20040010273 | Diduch et al. | Jan 2004 | A1 |
| 20040015177 | Chu | Jan 2004 | A1 |
| 20040249394 | Morris et al. | Dec 2004 | A1 |
| 20040260314 | Lizardi et al. | Dec 2004 | A1 |
| 20050043748 | Oren et al. | Feb 2005 | A1 |
| 20050085832 | Sancoff et al. | Apr 2005 | A1 |
| 20050222597 | Frank et al. | Oct 2005 | A1 |
| 20050234479 | Hatch et al. | Oct 2005 | A1 |
| 20050245932 | Fanton et al. | Nov 2005 | A1 |
| 20050288690 | Bourque et al. | Dec 2005 | A1 |
| 20060020273 | Hatch et al. | Jan 2006 | A1 |
| 20060190016 | Onuki et al. | Aug 2006 | A1 |
| 20060271073 | Lam et al. | Nov 2006 | A1 |
| 20060271074 | Ewers et al. | Nov 2006 | A1 |
| 20060282098 | Shelton et al. | Dec 2006 | A1 |
| 20070016248 | Cuschieri et al. | Jan 2007 | A1 |
| 20070060953 | Morris et al. | Mar 2007 | A1 |
| 20070123914 | Lizardi et al. | May 2007 | A1 |
| 20070149986 | Morris et al. | Jun 2007 | A1 |
| 20070225735 | Stone et al. | Sep 2007 | A1 |
| 20070255317 | Fanton et al. | Nov 2007 | A1 |
| 20070260259 | Fanton et al. | Nov 2007 | A1 |
| 20070270885 | Weinert et al. | Nov 2007 | A1 |
| 20080027468 | Fenton et al. | Jan 2008 | A1 |
| 20080208221 | Murray et al. | Aug 2008 | A1 |
| 20080255588 | Hinman | Oct 2008 | A1 |
| 20080275469 | Fanton et al. | Nov 2008 | A1 |
| 20080312669 | Vries et al. | Dec 2008 | A1 |
| 20090062816 | Weber | Mar 2009 | A1 |
| 20090062819 | Burkhart et al. | Mar 2009 | A1 |
| 20090088781 | Prestel et al. | Apr 2009 | A1 |
| 20090131956 | Dewey et al. | May 2009 | A1 |
| 20090177039 | Frank | Jul 2009 | A1 |
| 20100121352 | Murray et al. | May 2010 | A1 |
| 20100152751 | Meade et al. | Jun 2010 | A1 |
| 20100256656 | Park | Oct 2010 | A1 |
| 20110060350 | Powers et al. | Mar 2011 | A1 |
| 20110087245 | Weinert et al. | Apr 2011 | A1 |
| 20110118760 | Gregoire et al. | May 2011 | A1 |
| 20110152891 | McLawhorn et al. | Jun 2011 | A1 |
| 20110251626 | Wyman et al. | Oct 2011 | A1 |
| 20120116422 | Triplett et al. | May 2012 | A1 |
| 20120277767 | Powers et al. | Nov 2012 | A1 |
| 20130030450 | Dreyfuss et al. | Jan 2013 | A1 |
| 20140236193 | Chin et al. | Aug 2014 | A1 |
| Number | Date | Country |
|---|---|---|
| 4235602 | Apr 1994 | DE |
| 4334746 | Apr 1995 | DE |
| 0812572 | Aug 2003 | EP |
| 1067872 | Mar 2006 | EP |
| 1498075 | Aug 2009 | EP |
| 9639948 | Dec 1996 | WO |
| 9710756 | Mar 1997 | WO |
| Entry |
|---|
| Arthrotek, BiPass Suture Punch, 2006, 6 pages. |
| International Search Report for Application No. PCT/US2017/016854 dated Apr. 17, 2017. |
| Number | Date | Country | |
|---|---|---|---|
| 20170333030 A1 | Nov 2017 | US |
| Number | Date | Country | |
|---|---|---|---|
| 62302190 | Mar 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 15261521 | Sep 2016 | US |
| Child | 15479143 | US | |
| Parent | 15072243 | Mar 2016 | US |
| Child | 15261521 | US |