Patent Publication Number: US-2023149009-A1

Title: Suture anchor insertion assemblies and methods of use

Description:
FIELD 
     The present disclosure relates to surgical repair of tissue and, more specifically, to devices and methods for inserting a suture anchor used in such repair. 
     BACKGROUND 
     During surgical repair of tissue, surgeons commonly use suture anchors to attach the tissue or a tissue graft to bone. Typically, a surgeon uses an inserter tool to implant a suture anchor into a drilled bore in bone. In some case, the surgeon also connects one or more sutures or suture tape with attached needles to the suture anchor. The surgeon uses the needles to pass the suture through tissue and subsequently ties the suture to secure the tissue to the bone. 
     Some suture anchor inserters store both a portion of the suture and pre-attached needles within the handle, allowing for easy deployment by the user. In addition, such inserters provide tension on the suture, allowing the suture anchor to remain engaged with the inserter during the repair. However, problems occur by having needles pre-attached to the sutures and stored within the inserter. The needles cannot pass through the center of the inserter shaft without requiring an open slot in the shaft, which can weaken the insertion properties of the inserter. Also, misalignment of the inserter to the suture anchor, as well as an improper size or volume of suture and/or suture tape, can prevent suture slide after inserting the suture anchor into bone. 
     SUMMARY 
     Suture anchor insertion assemblies described herein include needles pre-attached to suture or suture tape, which reside within a housing of an inserter. The suture extends around a suture bridge of a suture anchor having at least one rib extending through the internal volume. An outer surface of the shaft of the inserter includes a groove sized to receive both the rib of the suture anchor and the length of suture while still allowing the suture to slide relative to the inserter. The suture anchor insertion assemblies of this disclosure advantageously allow for the use of a larger cross-sectional area and quantity of suture or suture tape compared to current assemblies, without requiring external voids in the inserter shaft that increase the risk of insertion failure. 
     Further examples of the suture anchor insertion assemblies and methods of this disclosure may include one or more of the following, in any suitable combination. 
     In examples, suture anchor insertion assemblies of this disclosure include a suture anchor having a body with a proximal end and a distal end. The body defines an internal volume. At least one rib extends through the internal volume between the proximal and distal ends of the body. The suture anchor insertion assemblies also include an inserter having a handle assembly and a shaft extending from the handle assembly. An exterior surface of the shaft defines at least one channel extending along a length of the shaft. The distal end of the shaft is configured for insertion within the interior volume of the suture anchor. The suture anchor insertion assemblies also include a flexible member having at least one leg. The at least one leg includes an end region coupled to a needle disposed within a proximal component of the handle assembly. The suture anchor is disposed on the distal end of the shaft such that the at least one rib engages the at least one channel, and the at least one leg of the flexible member extends through the interior volume of the suture anchor and along the at least one channel. 
     In further examples, the body of the suture anchor has a plurality of turns of threads extending from the proximal end to the distal end of the body, with apertures defined by spaces between the turns of the threads. In examples, the body of the suture anchor further includes a suture bridge at a distal end of the body. The flexible member extends around a distal end of the suture bridge. In examples, the distal end of the shaft includes an open slot defined between proximally-extending prongs and a divider member extending proximally from the open slot. The suture bridge resides within the open slot such that a proximal end of the suture bridge is adjacent to a distal end of the divider member. In examples, the at least one rib, the divider member, and sidewalls of the distal end of the shaft define at least one passage for passage of the at least one leg of the flexible member through the interior volume of the suture anchor. In examples, a cross-section of the divider member has a puzzle-cut. In examples, a central component of the handle assembly is configured to rotate relative to the proximal component of the handle assembly to release the end region of the flexible member and the needle from the handle assembly and/or to release the at least one leg of the flexible member from the at least one channel of the shaft. In examples, an additional flexible member is attached to the at least one leg of the flexible member. In other examples, another leg of the flexible member is attached to the at least one leg of the flexible member. 
     In examples, methods of inserting a suture anchor into bone of this disclosure include inserting a suture anchor of a suture anchor insertion assembly into bone. The suture anchor insertion assembly includes the suture anchor having a body with a proximal end and a distal end. The body defines an internal volume. At least one rib extends through the internal volume between the proximal and distal ends of the body. The suture anchor insertion assembly also includes an inserter having a handle assembly and a shaft extending from the handle assembly. An exterior surface of the shaft defines at least one channel extending along a length of the shaft. The distal end of the shaft is configured for insertion within the interior volume of the suture anchor. The suture anchor insertion assembly also includes a flexible member having at least one leg. The at least one leg includes an end region coupled to a needle disposed within a proximal component of the handle assembly. The suture anchor is disposed on the distal end of the shaft such that the at least one rib engages the at least one channel, and the at least one leg of the flexible member extends through the interior volume of the suture anchor and along the at least one channel. The central component is rotated relative to the proximal component of the handle assembly, and the inserter is removed from the bone. 
     In examples, rotating the central component relative to the proximal component allows for release of the end region of the flexible member and the needle from the proximal component of the handle assembly, and/or release of the at least one leg of the flexible member from the at least one channel of the shaft of the handle assembly. In examples, the body of the suture anchor has a plurality of turns of threads extending from the proximal end to the distal end of the body, with apertures defined by spaces between the turns of the threads. In examples, the body of the suture anchor further includes a suture bridge at a distal end of the body. The flexible member extends around a distal end of the suture bridge. In examples, the distal end of the shaft includes an open slot defined between proximally-extending prongs and a divider member extending proximally from the open slot. The suture bridge resides within the open slot such that a proximal end of the suture bridge is adjacent to a distal end of the divider member. In examples, the at least one rib, the divider member, and sidewalls of the distal end of the shaft define at least one passage for passage of the at least one leg of the flexible member through the interior volume of the suture anchor. In examples, a cross-section of the divider member has a puzzle-cut. 
     In examples, a kit for a surgical repair of this disclosure includes a suture anchor insertion assembly including a suture anchor having a body with a proximal end and a distal end. The body defines an internal volume. At least one rib extends through the internal volume between the proximal and distal ends of the body. The suture anchor insertion assembly also includes an inserter having a handle assembly and a shaft extending from the handle assembly. An exterior surface of the shaft defines at least one channel extending along a length of the shaft. The distal end of the shaft is configured for insertion within the interior volume of the suture anchor. The suture anchor insertion assembly also includes a flexible member having at least one leg. The at least one leg includes an end region coupled to a needle disposed within a proximal component of the handle assembly. The suture anchor is disposed on the distal end of the shaft such that the at least one rib engages the at least one channel, and the at least one leg of the flexible member extends through the interior volume of the suture anchor and along the at least one channel. The kit also includes another suture anchor insertion assembly different from the suture anchor insertion assembly, and a drill. In examples, the kit also includes a guide. 
     A reading of the following detailed description and a review of the associated drawings will make apparent the advantages of these and other features. Both the foregoing general description and the following detailed description serve as an explanation only and do not restrict aspects of the disclosure as claimed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Reference to the detailed description, combined with the following figures, will make the disclosure more fully understood, wherein: 
         FIG.  1    illustrates an example of a suture anchor insertion assembly of this disclosure in an assembled view; 
         FIGS.  2 A-C  illustrate examples of the inserter of the suture anchor insertion assembly of  FIG.  1   ; 
         FIG.  3 A  illustrates an example of the suture anchor of the suture anchor insertion assembly of  FIG.  1   ; 
         FIG.  3 B  illustrates an example of the distal end of the inserter for use with the suture anchor of  FIG.  3 A ; 
         FIG.  3 C  illustrates an assembly of the suture anchor of  FIG.  3 A  and the inserter of  FIG.  3 B ; 
         FIG.  3 D  illustrates a cross-section of the assembly of  FIG.  3 C ; 
         FIGS.  4 A and  4 B  illustrate another example of a suture anchor/inserter assembly ( FIG.  4 A ) and the distal end of the inserter thereof ( FIG.  4 B ); 
         FIGS.  5 A and  5 B  illustrate another example of a suture anchor/inserter assembly ( FIG.  5 A ) and the distal end of the inserter thereof ( FIG.  5 B ); 
         FIGS.  6 A and  6 B  illustrate additional examples of a suture anchor/inserter assembly; 
         FIGS.  7 A-C  illustrate a method of attaching additional sutures to the suture anchor insertion assembly of  FIG.  1   ; 
         FIGS.  8 A-D  illustrate a method of attaching one suture limb to another suture limb of the suture anchor insertion assembly of  FIG.  1   ; and 
         FIG.  9    is an example of a kit including the suture anchor insertion assembly of  FIG.  1   . 
     
    
    
     DETAILED DESCRIPTION 
     In the following description, like components have the same reference numerals, regardless of different illustrated examples. To illustrate examples clearly and concisely, the drawings may not necessarily reflect appropriate scale and may have certain features shown in somewhat schematic form. The disclosure may describe and/or illustrate features in one example, and in the same way or in a similar way in one or more other examples, and/or combined with or instead of the features of the other examples. 
     In the specification and claims, for the purposes of describing and defining the invention, the terms “about” and “substantially” represent the inherent degree of uncertainty attributed to any quantitative comparison, value, measurement, or other representation. The terms “about” and “substantially” moreover represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue. Open-ended terms, such as “comprise,” “include,” and/or plural forms of each, include the listed parts and can include additional parts not listed, while terms such as “and/or” include one or more of the listed parts and combinations of the listed parts. 
       FIG.  1    shows an example of a suture anchor insertion assembly  10  of this disclosure in an assembled view. A surgeon can use the suture anchor insertion assembly  10  for inserting a suture anchor  100  into bone, for example, during an Achilles tendon repair. As shown in  FIG.  1   , the suture anchor insertion assembly  10  generally includes an inserter  30  having a shaft  20  for engaging the suture anchor  100 . In examples, the suture anchor  100  has an open architecture, as further described below. A flexible member, such as suture tape or a suture  36 , extends from the suture anchor  100  along an outer surface of the shaft  20  to the handle  11  of the inserter  30 . Unlike some prior art inserter shafts, the shaft  20  does not include a central passage extending through a center of the shaft  20  for passage of the suture  36 . 
       FIG.  2 A  shows an example of the inserter  30  of the present disclosure in a perspective view. As shown in  FIG.  2 A , the shaft  20  of the inserter  30  includes a distal end  20   a  configured to engage the suture anchor, a proximal end  20   b  coupled to the handle  11 , and at least one external channel  20   c  extending along a length of the shaft  20 . In examples, the at least one channel  20   c  comprises two opposing channels  20   c , or more or fewer than two channels  20   c . The handle  11  generally includes a proximal component  12 , a central component  13 , and a distal component  14 . The proximal component  12  houses needles pre-attached to suture, as further described below. The central component  13  rotates relative to the proximal component  12  along the longitudinal axis L of the handle  11 . The central component  13  includes a top surface  13   a  having a groove  13   c , and a bottom surface  13   b  having a groove  13   d . The grooves  13   c ,  13   d  allow passage of the suture across the respective surfaces  13   a , 13   b  of the central component  13  to the proximal component  12 . The distal component  14  includes suture retainers  14   d  that extend within the channels  20   c  to retain the suture within the channels  20   c  prior to advancing the suture anchor into bone. 
       FIG.  2 B  illustrates the inserter  30  in a transparent view, showing needles  37  coupled to the ends  36   a  of the suture  36 . The ends  36   a  of the suture  36  house within the channels  20   c  of the shaft  20  and extend through the grooves  13   c , 13   d  ( FIG.  2 A ) of the central component  13  and into holes  12   a  in the proximal component  12 . The central component  13 , the proximal component  12 , and the ends  36   a  of the suture  36  interact to allow for retaining the ends  36   a  of the suture  36  in the grooves  13   c , 13   d , as further described below. Furthermore, the holes  12   a  of the proximal component  12  retain the needles  37  due to the central component  13  covering the holes  12   a  before rotation of the central component  13  relative to the proximal component  12 . 
       FIG.  2 C  shows the central component  13  rotated at about a 90° angle relative to the proximal component  12 , with other angles between about 0° and about 90° also within the scope of this disclosure. Rotating the central component  13  allows for removing the suture retainers  14   d  from the channels  20   c  of the shaft  20  and uncovering of the holes  12   a  in the proximal component  12 . This rotation allows for removing the suture and needles from the channels  20   c , the grooves  13   c , 13   d  and the holes  12   a . U.S. Pat. No. 9,050,077 to Smith &amp; Nephew, Inc. (Memphis, Tenn.), incorporated herein by reference, shows and describes other non-limiting examples of handles  11  configured for housing needles pre-attached to suture. 
       FIG.  3 A  shows an example of the suture anchor  100  of this disclosure in a detailed view. The suture anchor  100  includes a proximal end  101  and a distal end  102 . A majority of the suture anchor  100  includes screw threads  103  in the form of an open helical coil. The open helical coil has a connected series of continuous, regularly spaced turns of the threads  103  extending in a helical or spiral form substantially from the proximal end  101  to the distal end  102  of the suture anchor  100  with apertures  104  defined by spaces between the turns of the threads  103 . The suture anchor  100  defines an internal volume  110  communicating with the region exterior to the suture anchor  100  through the apertures  104 . Additionally, longitudinally-extending ribs  106  extend along the interior volume  110  of the suture anchor  100 . For the purposes of this disclosure, two longitudinally-extending ribs  106  extend along the interior volume  110 . However, the disclosure may include more or fewer than two ribs  106 . The distal end  102  of the suture anchor  100  also includes a suture bridge  105  that extends between the ribs  106  along a partial length of the suture anchor  100 . The suture bridge  105  includes a proximal end  105   a  and a distal end  105   b . In examples, the ribs  106  extend evenly with or distally past the suture bridge  105 . However, in other examples, the distal end  105   b  of the suture bridge may extend distally past the ribs  106 . In examples, the distal end  105   b  of the suture bridge  105  has a concave shape. However, the disclosure includes other shapes of the distal end  105   b  of the suture bridge  105 , such as bulbous or flat. The suture anchor  100  houses the suture  36  such that the suture  36  extends around the distal end  105   b  of the suture bridge  105  and legs  38  of suture  36  extend through the interior volume  110  of the suture anchor  100 . U.S. Pat. No. 9,949,820 to Smith &amp; Nephew, Inc. (Memphis, Tenn.), incorporated herein by reference, shows and describes other non-limiting examples of suture anchors configured for use with the suture anchor insertion assemblies  10  of this disclosure. 
     Turning now to  FIG.  3 B , the distal end  20   a  of the shaft  20  of the inserter  30  includes an open slot  202  defined by distally-extending, semi-circular prongs  204 . The disclosure contemplates two distally-extending prongs  204 , as well as more or fewer than two prongs  204 . The channels  20   c  extend proximally from the slot  202  on each side of a divider member  210  extending along the distal end  20   a  of the shaft  20 . The distal end  20   a  of the shaft  20  has a stepped-down diameter such that the distal end  20   a  of the shaft  20  has a smaller diameter than the diameter of the remainder of the shaft  20 . Thus, an annular neck portion  206  forms between the distal end  20   a  of the shaft  20  and the remainder of the shaft  20 . A circle defined by the prongs  204 , moreover, has smaller diameter than the diameter of the distal end  20   a  of the shaft  20  and the remainder of the shaft  20 . The portion of the channel  20   c  in the distal end  20   a  of the shaft  20  has a greater depth than the portion of the channel  20   c  in the remainder of the shaft  20  in order to house the ribs  106  of the suture anchor  100 . Thus, a first wall  208  forms between the portion of the channel  20   c  extending through the distal end  20   a  of the shaft  20  and the portion of the channel  20   c  extending through the remainder of the shaft  20 . Sidewalls  20   a ′ of the distal end  20   a  of the shaft and the divider member  210  extending from the first wall  208  define the portion of the channel  20   c  extending through the distal end  20   a  of the shaft. In examples, the divider member  210  integrally forms with the sidewalls  20   a′.    
     As shown in  FIG.  3 C , the suture anchor  100  sits on the distal end  20   a  of the shaft  20  such that the suture bridge  105  houses within the slot  202 , the ribs  106  house within the channels  20   c , and the proximal end  105   b  of the suture bridge  105  nears the distal end of the divider member  210 . Webbing  112  may extend between turns of the thread  103  at a region of the suture anchor  100  engaged with the prongs  204  to increase the rigidity of the distal end  102  of the suture anchor  100  and improve insertion performance of the suture anchor  100 . The suture  36  extends around the distal end  105   a  of suture bridge  105  and through the interior volume  110  of the suture anchor  100  such that the legs  38  of the suture  36  emerge from the proximal end  101  of the suture anchor  100  within the channels  20   c  in a region between the proximal end  101  of the suture anchor  100  and the neck portion  206  of the shaft  20 . The suture anchor  100  also sits on the distal end  20   a  of the shaft  20  such that no gaps or voids form between the threads  103  of the suture anchor  100  and the distal end  20   a  of the shaft  20 . 
       FIG.  3 D  shows a cross-section of the suture anchor  100  disposed on the distal end  20   a  of the shaft  20 . As shown, the ribs  106  of the suture anchor  100 , the sidewalls  20   a ′ of the distal end  20   a  of the shaft  20 , and opposing surfaces of the divider member  210  define passages  212 . In the example of  FIG.  3 D , the divider member  210  extends between the sidewalls  20   a ′ of the distal end  20   a  of the shaft  20  such that each passage  212  has a substantially equal area. The passages  212  allow for the passage of a respective leg  38  of the suture  36  (not shown) extending around the suture bridge  105 . 
       FIG.  4 A  shows another example of a cross-section of the suture anchor  100  disposed on the distal end  20   a  of the shaft  20  of this disclosure. In the example of  FIG.  4 A , one of the ribs  106   a  of the suture anchor  100 , the sidewalls  20   a ′, and a surface of the divider member  210  define only a single passage  212 . In this example, the divider member  210  advantageously provides support for the other of the ribs  106   b  to improve insertion performance of the suture anchor  100 . The passage  212  allows for the passage of both respective legs  38  of the suture  36  extending around the suture bridge  105 . Compared with the example of  FIG.  3 D , the single passage  212  advantageously allows for a greater amount of suture or suture tape to pass through the passage  212 . Additionally, the example of  FIG.  4 A  allows for aligning the suture or suture tape with the suture bridge  105  to facilitate suture slide within the passage  212 . 
       FIG.  4 B  shows the configuration of the distal end  20   a  of the shaft  20  of  FIG.  4 A  before coupling to the suture anchor  100 . In particular,  FIG.  4 B  shows a second wall  214  distal to the first wall  208  formed by the offset placement of the divider member  210  relative to a center of the shaft  20 . The divider member  210  extends distally from the second wall  214  to approach the proximal end  105   a  of the suture bridge  105 . 
       FIG.  5 A  shows another example cross-section of the suture anchor  100  disposed on the distal end  20   a  of the shaft  20  of this disclosure. In the example of  FIG.  5 A , a cross-section of the divider member  210  has a “puzzle cut” and extends between the sidewalls  20   a ′ such that each passage  212  has a substantially equal area. In this example, the divider member  210  advantageously provides partial support for both of the ribs  106  to improve the insertion performance of the suture anchor  100 . The passages  212  allow for the passage of respective legs  38  of the suture  36  extending around the suture bridge  105 . Webbing  112  may extend between turns of the thread  103  at a region of the anchor  100  engaged with the distal end  20   a  of the shaft  20  to increase the rigidity of the proximal end  101  of the suture anchor  100  and improve insertion performance of the suture anchor  100 . Compared with the example of  FIG.  3 A , the example of  FIG.  5 A  allows for aligning the suture or suture tape with the suture bridge  105  to facilitate suture slide within the passages  212 .  FIG.  5 B  shows the configuration of the distal end  20   a  of the shaft  20  of  FIG.  5 A  before coupling to the suture anchor  100 . 
       FIG.  6 A  shows another example cross-section of the suture anchor  100  disposed on the distal end  20   a  of the shaft  20  of this disclosure. In the example of  FIG.  6 A , a cross-section of the sidewalls  20   a ′ have a “dovetail” cut. The divider member  210  extends between the sidewalls  20   a ′ such that each passage  212  has a substantially equal area. In this example, the sidewalls  20   a ′ provide partial support for both of the ribs  106  to advantageously improve insertion performance of the suture anchor  100 . The passages  212  allow for the passage of respective legs  38  of the suture  36  extending around the suture bridge  105 . Webbing  112  may extend between turns of the thread  103  at a region of the anchor  100  engaged with the distal end  20   a  of the shaft  20  to increase the rigidity of the proximal end  101  of the suture anchor  100  and improve insertion performance of the suture anchor  100 . The dovetail cut of the sidewalls  20   a ′ may have any shape, angle or configuration, for example, as shown in  FIG.  6 B . 
     Turning now to  FIG.  7 A , in examples, the suture anchor insertion assembly  10  of this disclosure may include an additional suture tape or suture  40  preassembled to the legs  38  of the suture  36 . Preassembly of the additional suture  40  to the legs  38  of the suture  36  allows the surgeon to use the additional suture  40  in the repair with a single suture anchor while requiring fewer passes of the needle  37  through the tissue. As shown in  FIG.  7 A , the preassembly includes initially passing a loop of a suture passer  42  through one or more regions  44  of the leg  38  of the suture  36 . The additional suture  40  is then passed through the loop of the suture passer  42 . As shown in  FIG.  7 B , the suture passer  42  is then used to pull the additional suture  40  through the regions  44  of the leg  38  of the suture  36 . Thus, as shown in  FIG.  7 C , one pass of the needle  37  through tissue can carry one or more additional sutures  40  in addition to the limb  38  of the suture  36 . 
     In alternative examples, shown in  FIGS.  8 A-C , rather than attaching an additional suture to the legs of the suture  36 , the preassembly may instead include attaching a first leg  38   a  of the suture  36  extending from the suture anchor  100  to a second leg  38   b  of the suture  36  extending around the suture bridge of the suture anchor  100 . In examples, the first leg  38   a  can pass through two regions  44  of the second leg  38   b  ( FIG.  8 A ). In other examples, the first leg  38   a  can pass through three or more regions  44  of the second leg  38   b  ( FIG.  8 B ). In further examples, the first leg  38   a  can pass through only one region  44  of the second leg  38   b  ( FIG.  8 C ). In other examples, shown in  FIG.  8 D , both of an additional suture  40  and the first leg  38   a  can pass through regions  44  of the second leg  38   b.    
     As shown in  FIG.  9   , a kit  50  for a surgical repair, such as an Achilles tendon repair, may include at least one suture anchor insertion assembly  10  of this disclosure. In examples, the kit  50  may also include a suture anchor insertion assembly  52  different from the suture anchor insertion assembly  10  of this disclosure. In examples, the kit  50  may also include at least a guide  54  and/or a drill  56  for use in the surgical repair. 
     While the disclosure particularly shows and describes preferred examples, those skilled in the art will understand that various changes in form and details may exist without departing from the spirit and scope of the present application as defined by the appended claims. The scope of this present application intends to cover such variations. As such, the foregoing description of examples of the present application does not intend to limit the full scope conveyed by the appended claims.