Source: https://patents.justia.com/patent/9955963
Timestamp: 2020-04-08 06:41:06
Document Index: 643851802

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 61', 'Application No. 12810809', 'Application No. 2012282919', 'Application No. 12810809', 'Application No. 2014', 'Application No. 201280043613', 'Application No. 201280043613', 'Application No. 2014']

US Patent for Soft tissue repair Patent (Patent # 9,955,963 issued May 1, 2018) - Justia Patents Search
Justia Patents Mechanical Suture Or Ligature ApplierUS Patent for Soft tissue repair Patent (Patent # 9,955,963)
Nov 17, 2014 - Smith & Nephew, Inc.
Methods and instruments for repairing soft tissues of a skeletal joint, such as, for example, of the foot or hand are presented. Disclosed techniques include techniques for the repair of a palmar plate of a hand or foot, including advancing a foot of a suture passer through, or adjacent to, a joint space and advanced into a flexor tendon sheath a distance to produce an amount of suture purchase on a plantar/palmar plate. The foot of the suture passer can also be moved medially or laterally away from a joint midline but still within the flexor tendon sheath to further locate stitches. The sutures can then be secured to restore the function of the plantar/palmar plate.
This application is a divisional of U.S. patent application Ser. No. 13/781,281, filed on Feb. 28, 2013, which, is a continuation-in-part of U.S. patent application Ser. No. 13/623,837, filed Sep. 20, 2012, which is a continuation-in-part of U.S. patent application Ser. No. 13/527,424, filed Jun. 19, 2012, and is also a continuation-in-part of U.S. patent application Ser. No. 13/527,765, now U.S. Pat. No. 8,801,727, filed Jun. 20, 2012, both of which claim the benefit of U.S. Provisional Application No. 61/568,137, filed Dec. 7, 2011, U.S. Provisional Application No. 61/505,992, filed Jul. 8, 2011, U.S. Provisional Application No. 61/506,000, filed Jul. 8, 2011, U.S. Provisional Application No. 61/506,004, filed Jul. 8, 2011. All of the cross-referenced non-provisional and provisional applications are herein incorporated by reference.
In another aspect of the invention, a soft tissue to be repaired includes a volar ligament.
In another aspect of the invention, a distal portion of a suture passing instrument is inserted into a space adjacent the metapodial and phalangeal bones.
In another aspect of the invention, a distal portion of a suture passing instrument is inserted into a tendon sheath.
FIG. 8 is a side elevation view of the component of FIG. 7;
FIG. 78 is a perspective view of an illustrative example of a suture passer according to the present invention similar to that of FIG. 52;
FIGS. 79-101 illustrate the suture passers of FIGS. 5 and 52 in use to repair soft tissues; and
FIGS. 102-105 illustrate the suture passer of FIG. 5 in use to repair soft tissue.
The following illustrative examples illustrate instruments and techniques for treating skeletal joints. Instruments and techniques according to the present invention may be used in conjunction with any skeletal joint hut the illustrative examples are shown in a size and form most suitable for the joints of the hand and foot. The hand and foot have a similar structure, as shown for example, by at least FIGS. 2-4. Each has a volar aspect. In the hand, the volar, or palmar, aspect includes the palm of the hand and is the gripping side of the hand. In the foot, the volar, or plantar, aspect is the sole of the foot and is the ground contacting surface during normal walking. Both the hand, and foot have a dorsal aspect opposite the volar aspect. Both the hand and foot include long bones referred to as metapodial hones. In the hand, the metapodial bones may also be referred to as metacarpal bones. In the foot, the metapodial hones may also be referred to as metatarsal bones. Both the hand and foot include a plurality of phalanges that are the bones of the digits, the fingers and toes. In both the hand and foot, each of the most proximal phalanges forms a joint with a corresponding metapodial bone. This joint includes a volar plate or band of connective tissue on the volar side of the joint. The Joint also includes collateral ligaments on the medial and lateral sides of the joint. A transverse ligament connects the heads of the metapodial hones. In the hand, the joint is typically referred to as the metacarpophalangeal joint having a palmar plate on the palmar side, collateral ligaments medially and laterally, and a transverse ligament connecting the metacarpals. In the foot the joint is typically referred to as the metatarsophalangeal joint having a plantar plate on the plantar side, collateral ligaments medially and laterally including proper collateral ligaments and accessory collateral ligaments, and a transverse ligament also known as the transverse metatarsal ligament or transverse intermetatarsal ligament (IML).
The barrel assembly 400 includes a barrel bushing 410, a barrel 430, and a foot or support structure 450. The bushing 410 has a generally cylindrical body 412 having a through bore 414 with a longitudinal axis 416 extending from a proximal end 418 to a distal end 420. A flange 422 extends radially outwardly from the body 412 at a position intermediate the proximal and distal ends. An enlarged counter bore 424 (FIG. 12) is formed coaxial with the through bore 414 at the distal end 420 of the body 412. The barrel 430 includes an elongated hollow cylinder 432 having an outer diameter and an inner bore 434 defining a longitudinal axis 436 extending from a proximal end 438 to a distal end 440. The foot 450 is a generally hook-shaped member having a hollow post 452 having an outer diameter and an inner bore 454 defining a longitudinal axis 456 extending from a proximal end 458 of the cylinder to a distal end 460 of the foot 450. The foot will be described in greater detail below. The foot post 452 outer diameter fits within the inner bore 434 of the barrel at its distal end 440. The barrel 430 outer diameter, near its proximal end 438, fits within the counter bore 424 of the bushing. A coiled compression spring 250 fits coaxially over the needle assembly 300 within the bore 204 of the receiver 202 and rests against the distal end of the piston flange 322. The barrel assembly 400 fits coaxially over the needle assembly 300 and the outer diameter of the bushing 410, near its proximal end 418, fits within the counter bore 208 of the receiver 202 and is pressed proximally until the flange 422 abuts the receiver distal end 210. The proximal end of the bushing retains the spring 250 within the bore 204. The joints between the foot 450 and barrel 430, the barrel 430 and bushing 410, and the bushing 410 and receiver 202 are secured by pressing, gluing, pinning, welding, or other suitable securing means. Alternatively, the bushing, barrel, foot, or any combination of them may be made as a single piece. Pressing the button 390 distally translates the needle assembly from a first, proximal, retracted position distally along the needle axis 354 compressing the spring 250 and extending the needle 350 through the foot 450 to a second, distal, extended position. Releasing the button 390 allows the spring 250 to expand and bias the needle assembly 300 back toward the first position. The needle assembly 300 of the illustrative example of FIGS. 5-17 is a linear arrangement mounted for linear, coaxial translation in the housing 200 and barrel assembly 400 with the needle projecting straight through the foot to increase rigidity and power facilitating driving the needle 350 through difficult to penetrate materials and access confined spaces. The barrel 430 may have a circular, polygonal, or any other cross sectional shape.
FIGS. 13 and 14 illustrate the foot 450 of the illustrative example of FIGS. 5-17 in greater detail. The hooked portion of the foot 450 includes an elbow 462 having a first, proximal portion 464 extending distally from the post 452 along a proximal portion axis 465 diverging from the bore axis 456 at a first angle 466 relative to the bore axis 456. A second, distal portion 468 extends distally from the first portion 464 along a distal portion axis 469 converging toward the bore axis 456 at a second angle 470 relative to the bore axis 456. The first and second angles 466, 470 are chosen to allow the foot to extend into a confined space, for example behind material such as a portion of soft tissue such as a tendon or ligament, and position the receiver 202 so as not to obstruct the users view of the foot and needle. The first angle 466 is in the range of 0 to 180 degrees; preferably 0 to 90 degrees; more preferably 25 to 55 degrees; more preferably 35 to 45 degrees. In the illustrative example of FIG. 14, the first angle 466 is approximately 42 degrees. The second angle 470 is in the range of 0 to 90 degrees; preferably 25 to 55 degrees; more preferably 35 to 45 degrees. In the illustrative example of FIGS. 13 and 14, the second angle 470 is also approximately 42 degrees. Further, the proximal facing surface 474 can be at an obtuse angle relative to the axis of motion 456, as shown for example in FIG. 14. An eye 472 is formed through the second portion 468, from a proximal facing surface 474 to a distal facing surface 476, coaxial with the bore axis 456 for receiving the distal end of the needle 350 when the needle is in the second position. A hole 478 defining a hole axis 480 extends through the second portion 468 from the distal surface 476 and intersecting the eye 472. The hole 478 permits passing a suture strand from the distal surface 476 of the second portion 468 to the eye 472. The hole axis 480 forms an angle 482 relative to the bore axis 456. The angle 482 is between parallel to the proximal facing surface 474 of the second portion 468 and parallel to the distal facing surface of the first portion 464; preferably in the range of 45 to 135 degrees; more preferably 45 to 90 degrees. In the illustrative example of FIGS. 13 and 14, the hole angle 482 is approximately 90 degrees relative to the bore axis 456. A groove 484 is formed in the proximal surface 474 of the second portion 468 communicating from the eye 472 to the distal end 460. A notch 486 is formed through the distal end 460 from the proximal surface 474 to the distal surface 476 and communicating with the groove 484. The groove 484 and notch 486 are sized to receive a suture strand and retain the strand on the distal end of the foot 450. The proximal surface 474 of the second portion 468 of the foot 450 provides a supporting platform for material through which the needle 350 is passed. The eye 472 allows the needle 350 to penetrate all the way through the material and intercept a suture strand extending from the hole 478 to the groove 484.
FIG. 78 illustrates an illustrative example of an alternative configuration of the suture retriever 1300 of FIG. 52. In the illustrative example of FIG. 78, a suture retriever 1800 includes first and second guides 1810, 1812 each having a longitudinal guide axis 1814, 1816 and each mounted to the distal end of a handle 1822. The guide axes 1814, 1816 may be coplanar or they may lie in different planes. The guide axes 1814, 1816 may be parallel, they may bypass one another, or they may converge at a point. If they converge, they may converge distal to the foot 1818, at the foot 1818, or proximal to the foot 1818. For example, the guides 1810, 1812 may be oriented such that their axes do not converge and they can be used to guide a cutter to form non-converging holes in a bone. In another example, the guides 1810, 1812 may be oriented such that their axes converge proximal to the foot between the distal ends of the guides 1810, 1812 and the foot 1818 and they can be used to guide a cutter to form holes that intersect within, for example, a bone. In an exemplary method, the foot may be located at a desired location relative to a bone with a sharp tip 1820 embedded in the bone to help maintain the position of the retriever 1800. The first guide 1810 may be used to guide a cutter such as a drill to form a first tunnel in the bone. The second guide 1820 may be used to guide a cutter to form a second tunnel in the bone without the need to relocate the retriever 1800 to a second position.
FIGS. 102-105 depict an illustrative method to repair a volar ligament. For example, the technique may be used to repair a palmar plate of a human hand or a plantar plate of a human foot. A repair of the plantar plate of a human foot will be shown by way of example.
FIG. 102 depicts a cross section of a human foot taken through the head of the metatarsus 1900 near the MTP joint and looking back toward the heel. Extensor tendons 1902 run dorsal of the joint. Flexor tendons 1904 run plantar of the joint in a flexor tendon sheath 1906 below the plantar plate 1908. The IML 1890 extends from the plantar plate 1908 and connects the metatarsus 1900 to adjacent metatarsal bones 1910. Lumbrical tendons 1912 run below the IML 1890 between adjacent metatarsal bones and within a lumbrical tendon sheath 1914. Thin vertical bands 1914 of plantar aponeurosis form spaces housing adipose bodies. A preflexor adipose cushion 1916 is housed plantar to the flexor tendon sheath 1906 and above a longitudinal band of plantar aponeurosis 1918. Additional adipose bodies 1920 between adjacent rays cover neurovascular bundles 1922 and are housed in a space 1924. A transverse component 1926 of the plantar aponeurosis extends below these structures.
FIG. 104 depicts a partial side section view of the MTP joint showing the dorsal portion of the foot from the dorsal skin surface plantar to the flexor tendons 1904 and flexor tendon sheath 1906. The plantar plate 1908 may have a partial or complete tear. Typically, such tears originate at the insertion 1928 of the plantar plate on the medial or lateral aspect of the proximal phalanx 1931. A partial tear may be symptomatic. A partial tear may also progress to a full tear acutely or chronically. FIG. 104 illustrates a complete tear for simplicity of illustration.
Referring to FIGS. 103 and 104, a midline incision 1930 has been made over the MTP joint, the flexor tendons and joint capsule split, and the joint exposed. The flexor tendon sheath 1906 is exposed, if necessary, to allow visualization of the flexor tendons 1904. For example, in a partial tear it may be necessary to dissect through the plantar plate dorsally into the dorsal aspect of the flexor tendon sheath 1906 to gain access to the interval or space within the flexor tendon sheath 1906 and surrounding the flexor tendons 1904. Alternatively, the surgeon may sever the plantar plate to facilitate access. In a complete tear of the plantar plate 1908, the flexor tendon sheath 1906 may be readily identified by simply following the flexor tendons 1904 back to the plantar plate 1908. Once the flexor tendon sheath 1906 is identified, the distal end 460 of the foot 450 of the suture passer 100 is passed through, or adjacent to, the joint space and inserted into the flexor tendon sheath 1906 (FIG. 103). The foot 450 is advanced into the flexor tendon sheath 1906 a distance to produce the desired amount of suture purchase on the plantar plate 1908 (FIG. 104). The foot 450 may be moved medially or laterally away from the joint midline but still within the flexor tendon sheath 1906 to further locate stitches. For example, a first stitch 1932 may be placed on one side and a second stitch 1934 placed on another side (FIG. 105). The stitches are placed as described above relative to the operation of the suture passer 100. The sutures may then be secured to restore the function of the plantar plate 1908. For example, the sutures may be passed through tunnels in the proximal phalanx 1931 as in the illustrative methods described above.
Positioning the suture passer 100 by placing the distal end 460 in the flexor tendon sheath 1906 is advantageous in that it provides a clear anatomic landmark for suture placement well away from sensitive structures such as neurovascular bundles 1922. It also facilitates visualization of the flexor tendons and avoiding placing a stitch through the flexor tendons 1904. For example, by visualizing the flexor tendons 1904 and flexor tendon sheath 1906, the foot 450 of the suture passer 100 may be placed in the flexor tendon sheath and on top of the flexor tendons such that the suture will be passed through the plantar plate 1908 above the flexor tendons 1904.
Other anatomic landmarks and suture placements may also be utilized. For example, the interval between the lumbrical tendon 1912 and its sheath 1914 may also be identified and the foot 450 of the suture passer 100 placed in the sheath 1914 and on top of the lumbrical tendon such that the suture will be passed through the plantar plate, or more laterally, the IML 1890. While this interval may be used and may be preferred where a more lateral suture placement is desired, the lumbrical tendon 1912 and sheath 1914 may be more difficult to identify than the flexor tendons 1904 and flexor tendon sheath 1906 and the plantar plate/IML tissue at this more lateral location may not be as strong as it is midline.
Another example landmark is the interval defined by the space 1924 surrounding the adipose bodies 1920 and neurovascular bundles 1922. The foot 450 of the suture passer 100 may be placed in the space 1924 and on top of or away from the neurovascular bundles 1922. While this interval may be used and may be preferred where a more lateral suture placement is desired, this space 1924 may have the same difficulties as the lumbrical tendon sheath 1914 and further places the suture passer nearer the neurovascular bundle 1922.
inserting a portion of a suture into a suture hole at a distal facing surface of a distal portion of a suture passing instrument;
extending a piece of the suture from the suture hole, across an eye in a proximal facing surface of the distal portion, and over a distal end of the distal portion, the proximal facing surface and the distal facing surface being positioned on opposite sides of the distal portion;
inserting the distal portion of the suture passing instrument into a space adjacent the metapodial and phalangeal bones;
supporting at least a length of a portion of the soft tissue to be repaired against the proximal facing surface of the distal portion of the suture passing instrument;
intercepting, by a needle, a bight of the piece of the suture that extends across an inlet of the eye in the proximal facing surface of the distal portion, the inlet being adjacent to the supported soft tissue; and
moving the needle of the suture passing instrument to pass the suture through the supported soft tissue to be repaired, and wherein the soft tissue to be repaired comprises a volar ligament.
2. The method of claim 1 further comprising passing the suture through the volar ligament near a distal end of the metapodial bone and reattaching the volar ligament to the proximal phalanx.
3. The method of claim 2 further comprising making an incision on the dorsal aspect of the extremity to expose the dorsal aspect of the extremity and wherein the step of inserting the distal portion of the suture passing instrument comprises inserting the distal portion through the incision on the dorsal aspect of the extremity.
inserting the distal portion into a tendon sheath connected to a volar plate; and
passing a portion of a suture through the volar plate.
5. The method of claim 4 wherein passing a portion of a suture through the volar plate further comprises:
positioning the suture passing instrument medially within the tendon sheath;
passing a portion of a suture through a medial aspect of the volar plate;
positioning the suture passing instrument laterally within the tendon sheath; and
passing a portion of a suture through a lateral aspect of the volar plate.
6. The method of claim 5 wherein the portion of suture passed through the medial aspect and the portion of suture passed through the lateral aspect are portions of two separate sutures.
7. The method of claim 4 wherein the suture passing instrument comprises:
a housing defining a motion axis extending proximally to distally;
the needle being mounted for movement along the motion axis between a first proximal position and a second distal position; and
the distal portion comprising the distal facing surface and the proximal facing surface, the proximal facing surface forming an angle relative to the motion axis, the eye in the proximal facing surface aligned with the motion axis and able to receive the needle in the second position, the proximal facing surface having first and second lateral borders opposing one another on opposite sides of the eye and defining a support structure profile normal to the proximal facing surface, the support structure including a suture path able to positively receive a suture wrapped around the distal end of the distal portion such that the suture does not extend outside of the support structure profile.
8. The method of claim 1 wherein the suture passing instrument includes:
a support structure mounted to the housing, the distal portion of the support structure defining the proximal facing surface forming an obtuse angle relative to the motion axis.
inserting the distal portion of the support structure into a tendon sheath connected to a volar plate; and
10. The method of claim 1, wherein the suture hole is configured to provide a passage for the suture through the distal portion from the distal facing surface of the distal portion to the eye.
11. The method of claim 10, wherein the intercepting the bight of the suture includes intercepting a portion of the suture that extends across the eye between the suture hole and a groove of a support structure, the groove being in communication with the eye and extending along a portion of a proximal facing surface of the distal portion to the distal end, the distal end being at a tip of the distal portion, and wherein the groove is arranged non-parallel to the suture hole.
12. The method of claim 10, wherein the intercepting the bight of the suture includes displacing, by pressing, from a first position to a second position a button that is coupled to the needle to displace the needle toward a distal end of the suture passing instrument, the button being at a proximal end of the suture passing instrument.
13. The method of claim 12, wherein the moving the needle of the suture passing instrument to pass the suture through the supported soft tissue to be repaired includes releasing the pressed button, and wherein, when released, the button is biased to return from the second position to the first position by a spring.
14. A method of repairing soft tissue of a joint of a human extremity, the joint including a metapodial bone and a proximal phalanx, the extremity having volar and dorsal aspects, the method comprising:
positioning the proximal facing surface of the distal portion of a support structure of the suture passing instrument against a length of one side of the soft tissue, the suture passing instrument comprising a housing defining a linear motion axis extending proximally to distally, a needle mounted for translation along the motion axis between a first proximal position and a second distal position, and the distal portion, the proximal facing surface extending along a distal portion axis crossing the motion axis, the eye being aligned with the motion axis to receive at least a portion of the needle when the needle is in the second position;
supporting the soft tissue along a length of the proximal facing surface of the support structure;
extending the needle through the supported soft tissue and into the eye in the distal portion;
intercepting, by the needle, a bight of the piece of the suture that extends across a portion of the eye, the bight of the suture extending across the eye at an angle that is non-parallel to a central axis of the eye; and
retracting the needle to retrieve the bight of the suture through the soft tissue, and wherein the soft tissue to be repaired comprises a volar ligament.
15. The method of claim 14 further comprising making an incision on the dorsal aspect of the extremity to expose the dorsal aspect of the extremity and wherein the step of positioning the proximal facing surface of the distal portion of the support structure of the suture passing instrument comprises inserting the distal portion through the incision on the dorsal aspect of the extremity.
16. The method of claim 15 further comprising inserting the distal portion of the suture passing instrument into a tendon sheath connected to the volar ligament and passing the suture through the volar ligament.
17. The method of claim 14, wherein the suture hole is configured to provide a passage for the suture through the distal portion from the distal facing surface to the eye.
18. The method of claim 17, wherein the intercepting the bight of the suture includes intercepting a portion of the suture that extends across the eye between the suture hole and a groove of the support structure, the groove being in communication with the eye and extending along a portion of the proximal facing surface to the distal end, the distal end being at a tip of the distal portion.
19. The method of claim 17, wherein the intercepting the bight of the suture includes displacing, by pressing, from a first position to a second position a button that is coupled to the needle to displace the needle toward a distal end of the suture passing instrument, the button being at a proximal end of the suture passing instrument.
20. The method of claim 19, wherein the retracting the needle to retrieve the bight of the suture includes releasing the pressed button, and wherein, when released, the button is biased to return from the second position to the first position by a spring.
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Patent Publication Number: 20150073441
Assistant Examiner: Christie Bahena
Application Number: 14/543,377
International Classification: A61B 17/04 (20060101); A61B 17/17 (20060101); A61F 2/08 (20060101); A61B 17/06 (20060101);