Abstract:
The present disclosure relates to an instrument and method of manipulating soft tissue during a soft tissue repair procedure. The instrument and related method may include use of a handle and a shaft coupled to the handle, the shaft including a proximal portion and a distal portion, wherein the distal portion of the shaft comprises a tip including at least two prongs and a channel located between the prongs.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a continuation of U.S. patent application Ser. No. 12/725,686, filed Mar. 17, 2010, which claims priority to U.S. Provisional Patent Application No. 61/161,124, filed Mar. 18, 2009, and is related to U.S. patent application Ser. No. 14/642,337, filed on Mar. 9, 2015, which is a divisional of U.S. patent application Ser. No. 12/725,686; the disclosures of all of which are incorporated by reference herein in their entirety. 
    
    
     BACKGROUND 
     Field of Technology 
     The present disclosure relates to a device and method for manipulating soft tissue during a soft tissue repair procedure. 
     Related Art 
     During repair of soft tissue, such as biceps tenodesis repair, the biceps tendon is placed and temporarily secured in a prepared hole in the humerus prior to final fixation of the tendon via a fixation device, such as an interference screw. Devices that would accomplish this temporary placement and fixation are needed. 
     SUMMARY 
     In one aspect, the present disclosure relates to an instrument for manipulating soft tissue during a soft tissue repair procedure. The instrument includes a handle; and a shaft coupled to the handle, the shaft including a proximal portion and a distal portion, wherein the distal portion of the shaft comprises a tip including at least two prongs and a channel located between the prongs. In an embodiment, the instrument is cannulated. In another embodiment, the distal portion includes marks, the marks representing a measured distance from an end of at least one of the prongs to the marks. In yet another embodiment, an outer diameter of the tip is between about 4.5 mm to about 5.5 mm. 
     In another aspect, the present disclosure relates to a method of tissue repair. The method includes creating a hole in bone; placing the soft tissue over the hole; providing a cannulated instrument for inserting the soft tissue into the hole, the instrument including a handle and a shaft coupled to the handle, the shaft including a proximal portion and a distal portion, wherein the distal portion includes a tip including at least two prongs and a channel located between the prongs; inserting the soft tissue into the hole via use of the instrument, wherein the soft tissue is housed within the channel; and inserting a fixation device into the hole to fix the soft tissue to the bone. In an embodiment, the method further includes inserting a guide assembly through the cannulation of the instrument and into the bone prior to inserting the fixation device into the hole, the guide assembly comprising a guide wire and a vice coupled to the guide wire, the guide assembly inserted through the cannulation until a bottom portion of the vice engages with the handle. In yet another embodiment, the method further includes inserting the fixation device into the hole via use of the guide wire. 
     In a further aspect, the present disclosure relates to a soft tissue manipulator assembly. The manipulator assembly includes a soft tissue manipulator instrument having a handle, a shaft coupled to the handle, a tip coupled to the shaft, and a cannulation extending an entire length of the instrument; and a guide assembly disposed within the cannulation, the assembly comprising a guide wire and a vice coupled to the guide wire, the vice including a bottom portion and a top portion, the bottom portion in engagement with the handle. 
     In yet a further aspect, the present disclosure relates to a kit. The kit includes a soft tissue manipulator instrument including a handle, a shaft coupled to the handle, and a tip coupled to the shaft; a guide wire; a vice including a top portion and a bottom portion, the bottom portion having a channel and a hole extending perpendicular to the channel; and a fixation device. In an embodiment, the kit further includes a drill bit; a reamer; and a driver. 
     Embodiments of the invention may include a method of attaching a biceps tendon to a humerus. Methods may include creating a hole in the humerus of a first diameter; severing a proximal end of the biceps tendon; pushing a portion of the biceps tendon into the hole with an instrument that captures the biceps tendon at a distal end of the instrument; inserting a distal portion of a guide wire though the biceps tendon and into humerus in the hole in the humerus; and inserting a fixation device over the guide wire to fix the biceps tendon to the humerus. 
     Still other embodiments of the invention may include a method of tissue repair that includes creating a hole in a bone of a first diameter; pushing a portion of soft tissue into the hole with an instrument that captures the soft tissue in a channel adjacent to one or more prongs of a tip at a distal end of the instrument; inserting a distal portion of a guide wire though the soft tissue and in the hole in the bone; and inserting a fixation device over the guide wire to fix the soft tissue to the bone. 
     Embodiments of the invention may be directed to an instrument with a proximal end and a distal end, the instrument configured to manipulate soft tissue during a soft tissue repair procedure. The instrument may include a cannulated instrument body and a first prong coupled to the cannulated instrument body, wherein the first prong is the most distal element of the instrument and is offset from the cross-sectional center of the cannulated instrument body. The instrument may also include markings on the instrument representing a measured distance from a distal end of the first prong to the markings. 
     Other embodiments of the invention include an instrument with a proximal end and a distal end, the instrument configured to manipulate soft tissue during a soft tissue repair procedure. The instrument may include a cannulated instrument body, a first prong coupled to the cannulated instrument body, wherein the first prong is the most distal element of the instrument and is offset from the cross-sectional center of the cannulated instrument body, and a second prong coupled to the cannulated instrument body opposite from the first prong to form a channel between the first prong and the second prong, wherein the channel aligns at least in part with a cannulation of the cannulated instrument body. The first prong and the second prong may be rounded and blunted at their respective distal ends to not readily penetrate bone when pushed against the bone. 
     Yet other embodiments includes an instrument with a proximal end and a distal end, the instrument configured to manipulate soft tissue during a soft tissue repair procedure. The instrument may have a cannulated instrument body, a fork means at a distal end of the instrument for capturing soft tissue between a first prong of the fork and a second prong of the fork and aligning the soft tissue with a cannulation of the cannulated instrument body, and a depth determining means for measuring a distance from a distal end of the fork means to markings on the instrument. 
     Further areas of applicability of the present disclosure will become apparent from the detailed description provided hereinafter. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the disclosure, are intended for purposes of illustration only and are not intended to limit the scope of the disclosure. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The accompanying drawings, which are incorporated in and form a part of the specification, illustrate the embodiments of the present disclosure and together with the written description serve to explain the principles, characteristics, and features of the disclosure. In the drawings: 
         FIG. 1  shows a side view of the soft tissue manipulator instrument of the present disclosure. 
         FIG. 1A  shows an expanded view of the distal portion of the shaft of the instrument of  FIG. 1 . 
         FIG. 2  shows a cross-sectional view of the instrument of  FIG. 1 . 
         FIGS. 3A-3C  each show isometric views of the tip of the instrument of  FIG. 1 . 
         FIG. 4A  shows a side view of the guide assembly of the present disclosure. 
         FIG. 4B  shows a cross-sectional view of the guide assembly of  FIG. 4A . 
         FIG. 5A  shows a side view of the soft tissue manipulator assembly of the present disclosure. 
         FIG. 5B  shows a cross-sectional view of the soft tissue manipulator assembly of  FIG. 5A . 
         FIGS. 6-6A  show the soft tissue manipulator instrument of  FIG. 1  and a drill bit disposed within the instrument prior to creation of a hole in bone. 
         FIGS. 7-7A  show the use of a reamer to increase the diameter of the hole created by the drill bit of  FIGS. 6-6A . 
         FIG. 8  shows the insertion of the soft tissue manipulator assembly of  FIG. 5A  in bone. 
         FIG. 8A  shows a representation of area  100  of  FIG. 8  with soft tissue (not shown in  FIG. 8 ) having been inserted into the bone via the soft tissue manipulator assembly of  FIG. 5A . 
         FIG. 9  shows disposal of the guide wire of the guide assembly of  FIG. 4A  within bone. 
         FIG. 9A  shows a representation of area  200  of  FIG. 9  with soft tissue (not shown in  FIG. 9 ). 
         FIG. 10  shows insertion of a fixation device into bone via use of a driver. 
         FIG. 10A  shows a representation of area  300  of  FIG. 10  with soft tissue (not shown in  FIG. 10 ). 
         FIG. 11  shows disposal of the guide wire of the guide assembly of  FIG. 4A  and the fixation device of  FIGS. 10-10A  within bone. 
         FIG. 11A  shows a representation of area  400  of  FIG. 11  with soft tissue (not shown in  FIG. 11 ). 
         FIG. 12  shows disposal of the fixation device of  FIGS. 10-10A  within bone. 
         FIG. 12A  shows a representation of area  500  of  FIG. 12  with soft tissue (not shown in  FIG. 12 . 
     
    
    
     DETAILED DESCRIPTION OF THE EMBODIMENTS 
     The following description of the preferred embodiment(s) is merely exemplary in nature and is in no way intended to limit the disclosure, its application, or uses. 
       FIGS. 1 and 2  show the soft tissue manipulator instrument  10  of the present disclosure. The instrument  10  includes a handle  11  and a shaft  12  coupled to the handle  11 . The instrument  10  includes a cannulation  14  that extends the entire length of the instrument  10 . The shaft  12  includes a proximal portion  12   a  coupled to the handle  11  and a distal portion  12   b . The distal portion  12   b  includes a tip  13  having prongs  13   a  and a channel  13   b  located between the prongs  13   b .  FIGS. 3A-3C  show three tips  13 , all of which have a different outer width W. For the purposes of this disclosure, the widths W of the tips  13  are 4.5 mm, 5.0 mm, and 5.5 mm. However, other widths W may be used. As will be described further below, the choice of which instrument  10  to use will depend on the diameter of the soft tissue that is being repaired. In addition,  FIG. 1A  shows markings  12   b ′, and numbers correlating with those markings, located at the distal portion  12   b  of the shaft  12 . As will be further described below, the markings  12   b ′ are used to determine the depth of a bone hole during repair. 
       FIGS. 4A and 4B  show the guide assembly  20  of the present disclosure. The assembly  20  includes a guide wire  21  having a proximal portion  21   a  and a distal portion  21   b . Coupled to the proximal portion  21   a  of the guide wire  21  is a wire vice  22 . The vice  22  includes a top portion  22   a , a bottom portion  22   b , a channel  22   c  that houses the proximal portion  21   a  of the guide wire  21 , a hole  22   d  extending perpendicular to the channel  22   c  and having threads on an inner surface  22   d ′ of the hole  22   d , and a knob assembly  22   e  housed within the hole  22   d . The assembly  22   e  includes a knob  22   f  and a pin  22   g  coupled to the knob  22   f . The pin  22   g  includes a proximal portion  22   g ′ coupled to the knob  22   f  and a distal portion  22   g ″ having threads that are engaged with the threads on the inner surface  22   d ′ of the hole  22   d . Prior to use of the guide assembly  20  during repair, the proximal portion  21   a  of the guide wire  21  is disposed within the channel  22   c  of the vice  22  and the knob  22   f  of the knob assembly  22   e  is rotated until the distal portion  22   g ″ of the pin  22   g  abuts the proximal portion  21   a  of the guide wire  21 , thereby coupling the assembly  22   e  to the proximal portion  21   a  of the guide wire  21 . 
       FIGS. 5A and 5B  show the soft tissue manipulator assembly  30  of the present disclosure. As will be further described below, the assembly  30  is used to insert tissue into bone. 
       FIGS. 6-12  show a method of soft tissue repair.  FIGS. 6 and 6A  show the soft tissue instrument  10  and a drill bit  40  disposed within the cannulation  14  of the instrument  10 . The drill bit  40  includes a proximal portion  41  and a distal portion  42  having threads  43 . The instrument  10  is used as a guide for placement of the drill bit  40  into bone  50 . Once the drill bit  40  is disposed in the instrument  10 , as shown in  FIG. 6 , a drill (not shown) is coupled to the proximal portion  41  of the bit  40  and is operated to rotate the bit  40  and advance the bit  40  into the bone  50 . For the purposes of this disclosure, the drill bit  40  is 2.4 mm in diameter, but other diameter drill bits may be used. Once the bit  40  is advanced into the bone  50 , the instrument  10  is removed while the drill bit  40  is maintained in bone  50 . 
     As shown in  FIGS. 7 and 7A , a cannulated reamer  60  is disposed over the drill bit  40  and is used to provide the create a hole  51  in the bone  50 . The reamer  60  includes a distal portion  61  having threads  61   a  and a proximal portion  62 . Once the reamer  60  is disposed over the drill bit  40 , a drill (not shown) is then coupled to the proximal portion  62  and operated to rotate the reamer  60  and advance the reamer  60  into the bone  50 , thereby creating the hole  51 . For the purposes of this disclosure, the diameter of the reamer  60  is 6-8 mm, however the diameter is dependent on the diameter of the soft tissue that is placed within the hole  50 , as will be further described below. Therefore, other diameter reamers may be used. In addition, the distal portion  61  of the reamer  60  may include number markings, similar to the markings  12   b ′ described above, for measuring the depth of the reamer  60  as it is being advanced into the bone  50 . 
     Once the reamer  60  and the drill bit  40  have been removed from the bone  50 , the soft tissue manipulator instrument  10  is used to manipulate the soft tissue  70  and place the soft tissue  70  within the channel  13   b . The shaft  12  of the instrument  10  and the soft tissue  70  are then placed within the hole  51  and the guide assembly  20  is placed within the cannulation  14  of the instrument  10  until the bottom portion  22   b  of the vice  22  abuts the handle  11  of the instrument  10 , as shown in  FIG. 8 . At the same time, the distal portion  21   b  of the wire  21  is inserted through the soft tissue  70  and subsequently disposed within the bone  50  lying beneath the hole  51 , as shown in  FIG. 8A . The distal portion  21   b  of the wire  21  is inserted into the bone  50  by tapping the top portion  22   a  of the vice  22  with a mallet, or another striking force, until the bottom portion  22   b  abuts the handle  11 . The vice  22  acts as a depth stop in limiting the depth of the distal portion  21   b  of the wire  21  into the bone  50 . Other factors that limit the depth of the distal portion  21   b  into the bone  50  include, without limitation, the length of the wire  21 , the length of the instrument  10 , and the depth of the channel  22   a.    
       FIGS. 9 and 9A  show that the vice  22  has been removed from the proximal portion  21   a  of the wire  21  by disengaging the pin  22   g  from the wire  21  and uncoupling the vice  22  from the proximal portion  21   a . The instrument  10  has also been removed from the hole  51 , thereby leaving the wire  21  alone in the hole  51 . 
     The wire  21  is subsequently used to guide the insertion of a fixation device  80 , such as an interference screw, into the hole  51 , as shown in  FIGS. 10 and 10A . A driver assembly  90 , which includes a cannulated driver  91  having a handle  91   a  and a shaft  91   b  coupled to the handle  91   a  and the cannulated fixation device  80  coupled to the shaft  91   b , is disposed over the wire  21 . The driver  91  is rotated to insert the device  80  into the hole  51 , such that the threaded outer surface  81  of the device  80  is engaged with the soft tissue  70 , thereby fixating the soft tissue  70  to the bone  50 . After insertion of the device  80  into the hole  51 , the driver  91  and the wire  21  are both removed from the bone  50 , thereby leaving the device  80  within the hole, as shown in  FIGS. 11-11A and 12-12A . The wire  21  is removed by placing the proximal portion  21   a  into the channel  22   c  of the vice  22 , rotating the knob  22   f  to couple the assembly  22   e  to the wire  21 , and then using the assembly  22   e  to remove the wire  21  from the hole  50 . Other methods of removing the wire  21  are also within the scope of this disclosure. 
     The soft tissue manipulator instrument  10  and drill bit  40  are made from a biocompatible material, such as titanium, stainless steel, or other biocompatible material and via a machining process or other process known to one of skill in the art. A combination of processes may also be used to make the instrument  10  and drill bit  40 . The cannulation  14  and channel  13   b  are formed during or after the machining process via a method, such as drilling. The markings  12   b ′ and associated numbers are formed by a laser or another method and the threads  43  are formed via a machining process. 
     The guide assembly  20  and its components and the reamer  60  are also made from a biocompatible material, such as titanium, stainless steel, or other biocompatible material and via a machining process or other process known to one of skill in the art. A combination of processes may also be used to make the assembly  20  and reamer  60 . The channel  22   c , hole  22   d , cannulation, and threads on the inner surface  22   d ′ of the hole  22   d , the distal portion  22   g ″ of the pin  22   g , and the reamer  60  are formed during or after the machining process via a process, such as drilling or other process known to one of skill in the art. 
     The fixation device  80  is made from a resorbable polymer material. However, a metal material and other non-metal materials, either resorbable or non-resorbable, are also within the scope of this disclosure. In addition, the device  80  may be made via a molding process or other process known to one of skill in the art. The cannulation and threads on the outer surface  81  of the device  80  may be formed during the molding process or after the molding process by drilling or machining. 
     As various modifications could be made to the exemplary embodiments, as described above with reference to the corresponding illustrations, without departing from the scope of the disclosure, it is intended that all matter contained in the foregoing description and shown in the accompanying drawings shall be interpreted as illustrative rather than limiting. Thus, the breadth and scope of the present disclosure should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims appended hereto and their equivalents.