Patent Abstract:
An assembly and method for reattaching tissue to bone from which the tissue had detached including a tissue fixation member will with a narrow cross section and a suture securely attached to the fixation member, the fixation member being configured to secure the detached tissue, a suture anchor fixable in bone at the region of reattachment, the anchor having an eyelet, the anchor including a textured outer surface, the suture having a free end passable through the eyelet to enable the detached tissue to be drawn into engagement with the bone at the region of reattachment.

Full Description:
BACKGROUND OF INVENTION 
     Meniscus repairs have been shown to be effective, especially with tears in the peripheral one-third of the meniscus. Various techniques have evolved to perform this demanding procedure. Initially, open repairs were done that proved the feasibility of the procedure. Subsequently, several techniques involving the arthroscope were developed to assist in these repairs. Most of the techniques have been a variation of the outside-in, or more commonly, the inside-out techniques. These repair procedures have shown to be technically demanding, but more importantly, have inherent risks to the neurovascular structures about the knee. Most of the techniques describe an ancillary incision, either medial and/or lateral, for the purpose of performing the repair and specifically to protect these important structures. In addition, these repairs tether the posterior capsule, causing extension difficulties in the post-operative rehabilitation phase. 
     Accordingly, there exists a need for an assembly for meniscal repair that reduces the difficulties and time to repair the meniscus. 
     SUMMARY OF INVENTION 
     According to one aspect of the present invention, there is provided an assembly for meniscal repair including a first tissue fixation member configured to secure a meniscal tissue, a suture anchor having a proximal end, a distal end, a central axis defined therethrough, an eyelet, and a textured outer surface, and a first suture configured to be coupled to the first tissue fixation member and configured to be received through the eyelet of the suture anchor. 
     According to another aspect of the present invention, there is provided a method for meniscal repair including providing a first tissue fixation member configured to secure a meniscal tissue, a suture anchor having an eyelet, and a first suture, securing the first suture to the first tissue fixation member, securing the first tissue fixation member to a meniscal tissue, threading the first suture through the eyelet of the suture anchor, securing the suture anchor within a bone, and tensioning the first suture within the suture anchor. 
     According to another aspect of the present invention, there is provided a kit for meniscal repair including at least one tissue fixation member configured to secure a meniscal tissue, a suture anchor comprising an eyelet, at least one suture configured to be coupled to the at least one tissue fixation member and configured to be received through the eyelet of the suture anchor, and a delivery device configured to assist with delivery of the at least one tissue fixation member into a body. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         FIGS. 1A-1C  are multiple views of an assembly for meniscal repair in accordance with embodiments disclosed herein. 
         FIG. 2  is an illustration of a suture anchor and associated plug. 
     
    
    
     DETAILED DESCRIPTION 
     The following is directed to various exemplary embodiments of the disclosure. Although one or more of these embodiments may be preferred, the embodiments disclosed should not be interpreted, or otherwise used, as limiting the scope of the disclosure, including the claims. In addition, those having ordinary skill in the art will appreciate that the following description has broad application, and the discussion of any embodiment is meant only to be exemplary of that embodiment, and not intended to suggest that the scope of the disclosure, including the claims, is limited to that embodiment. 
     Certain terms are used throughout the following description and claims refer to particular features or components. As those having ordinary skill in the art will appreciate, different persons may refer to the same feature or component by different names. This document does not intend to distinguish between components or features that differ in name but not function. The figures are not necessarily to scale. Certain features and components herein may be shown exaggerated in scale or in somewhat schematic form and some details of conventional elements may not be shown in interest of clarity and conciseness. 
     In the following discussion and in the claims, the terms “including” and “comprising” are used in an open-ended fashion, and thus should be interpreted to mean “including, but not limited to . . . .” Also, the term “couple” or “couples” is intended to mean either an indirect or direct connection. Thus, if a first component is coupled to a second component, that connection may be through a direct connection, or through an indirect connection via other components, devices, and connections. Further, the terms “axial” and “axially” generally mean along or substantially parallel to a central or longitudinal axis, while the terms “radial” and “radially” generally mean perpendicular to a central, longitudinal axis. 
     Referring generally to  FIGS. 1A-1C , an assembly for meniscal repair  100 , according to embodiments disclosed herein, is shown. In one or more embodiments, the assembly  100  may include a first tissue fixation member  101  configured to secure a meniscal tissue  130 , a suture anchor  110  having a proximal end  111 , a distal end  112 , a central axis  150  defined therethrough, an eyelet (not shown), and a textured outer surface, and a first suture  105  configured to be coupled to the first tissue fixation member  101  and configured to be received through the eyelet of the suture anchor  110 . 
     In one or more embodiments, the first tissue fixation member  101  may be a substantially rigid, bar or rod-shaped member. Alternatively, in one or more embodiments, the first tissue fixation member  101  may have a curved shape and may be formed from a flexible material, such as a plastic or polymer. In one or more embodiments, the first tissue fixation member  101  may be formed from any biocompatible material known in the art, including plastics, polymers, metals, and any combination thereof. The first tissue fixation member  101  may engage with the meniscal tissue  130  and may be used to secure the meniscal tissue  130 , e.g., against a tibia  125 . 
     In one or more embodiments, the assembly  100  may also include a second tissue fixation member  102  configured to secure the meniscal tissue  130 . In one or more embodiments, the second tissue fixation member  102  may be substantially identical to the first tissue fixation member  101 . For example, as discussed above, in one or more embodiments, the second tissue fixation member  102  may be a substantially rigid, bar or rod-shaped member. Alternatively, in one or more embodiments, the second tissue fixation member  102  may have a curved shape and may be formed from a flexible material, such as a plastic or polymer. In one or more embodiments, the second tissue fixation member  102  may be formed from any biocompatible material known in the art, including plastics, polymers, metals, and any combination thereof. The second tissue fixation member  102 , like the first tissue fixation member  101 , may engage with the meniscal tissue  130  and may be used to secure the meniscal tissue  130 , e.g., against a tibia  125 . Those having ordinary skill in the art will appreciate that more than two tissue fixation members may be used in the assembly  100  to assist with securing the meniscal tissue  130 . For example, three, four, five, or more tissue fixation members, that may be substantially identical to the first tissue fixation member  101  and the second tissue fixation member  102 , may be used in the assembly  100  to assist with securing the meniscal tissue  130 . 
     As shown in  FIG. 1A , the first suture  105  is coupled to the first tissue fixation member  101 . Further, as shown, a second suture  106  is coupled to the second tissue fixation member  102 . In one or more embodiments, each of the first tissue fixation member  101  and the second tissue fixation member  102  may include holes, or notches, formed therethrough, through which each of the first suture  105  and the second suture  106  may be engaged with, or coupled to, the first tissue fixation member  101  and the second tissue fixation member  102 , respectively. Those having ordinary skill in the art will appreciate that the first suture  101  and the second suture  102  may be formed from any material known in the art. For example, in one or more embodiments, each of the first suture  101  and the second suture  102  may be formed from a biocompatible polyester or polyester closure tape and may be, for example, a single or double-arm 2-0 braided non-absorbable polyester suture. 
     As shown in  FIGS. 1B and 1C , the suture anchor  110  includes an eyelet (not shown), in which each of the first suture  105  and the second suture  106  are configured to be received through the eyelet of the suture anchor  110 . In one or more embodiments, the eyelet of the suture anchor  110  may be a transverse hole that is located between the proximal end  111  and the distal end  112  of the suture anchor  110 , and may be formed through the suture anchor  110 . Further, as shown, the eyelet may be located near the distal end  112  of the suture anchor  110 . However, those having ordinary skill in the art will appreciate that the eyelet may be located at any other position on the suture anchor  110 , and that the eyelet is not limited to being formed near the distal end  112  of the suture anchor  110 . For example, the eyelet may be formed near the proximal end  111  of the suture anchor  110  or through a region of the suture anchor  110  between the proximal end  111  and the distal end  112  of the suture anchor  110 . Those having ordinary skill in the art will appreciate that more than one suture anchor  110  may be included in the assembly  100 . For example, two, three, or more suture anchors that may be substantially identical to the suture anchor  110  may be included in the assembly  100 . 
     In one or more embodiments, the textured outer surface of the suture anchor  110  may be formed near the distal end  112  of the suture anchor  110 . However, those having ordinary skill in the art will appreciate that the textured outer surface of the suture anchor  110  may be formed any other surface of the suture anchor  110  and that the textured outer surface of the suture anchor  110  is not limited to being formed near the distal end  112  of the suture anchor  110 . For example, in one or more embodiments, the textured outer surface of the suture anchor  110  may be formed on the entire outer surface of the suture anchor  110 . Alternatively, in one or more embodiments, the textured outer surface of the suture anchor  110  may be formed near the proximal end  111  of the suture anchor. 
     Further, in one or more embodiments, the textured outer surface of the suture anchor  110  may be a threaded outer surface. In one or more embodiments, the textured outer surface of the suture anchor  110  may be a threaded outer surface that may be configured to self-tap into a bone, e.g., the tibia  125 . For example, as will be discussed below, a hole may be formed into the tibia  125 . Subsequently, in one or more embodiments, the suture anchor  110  may be aligned with the hole secured within the tibia  125 , such that the threaded outer surface of the suture anchor  110  may engage with, and may form corresponding threads within, the hole formed in the tibia  125 . 
     Furthermore, in one or more embodiments, the textured outer surface of the suture anchor  110  may be a stepped outer surface. For example, in one or more embodiments, the outer surface of the suture anchor  110  may include steps, or barbs, that may be configured to reduce the possibility of unwanted removal of the suture anchor  110  from a bone, e.g., the tibia  125 . Those having ordinary skill in the art will appreciate that the suture anchor  110  may include any number of steps, or barbs, formed on the outer surface of the suture anchor  110 . 
     In one or more embodiments, the assembly  100  may also include a fixation plug (not shown) that may be configured to engage with the suture anchor  110 . For example, in one or more embodiments, the suture anchor  110  may include a longitudinal hole formed along the central axis  150  of the suture anchor  110  to receive the fixation plug. In one or more embodiments, the fixation plug may be configured to secure at least one suture, e.g. the first suture  105  and the second suture  106 , within the eyelet of the suture anchor  110 . In one or more embodiments, the longitudinal hole formed through the suture anchor  110  along the central axis  150  of the suture anchor  110  may be a threaded hole. For example, in one or more embodiments, the fixation plug may include corresponding threads that may allow the fixation plug to threadably engage with the suture anchor  110 , i.e., with the longitudinal hole of the suture anchor  110 . As such, in one or more embodiments, the first suture  105  and the second suture  106  may be disposed, or threaded, through the eyelet of the suture anchor  110 . Subsequently, in one or more embodiments, the fixation plug may be engaged within the longitudinal hole of the suture anchor  110 , which may secure the first suture  105  and the second suture  106  within the eyelet of the suture anchor  110 . Those having ordinary skill in the art will appreciate that more than two sutures may be disposed, or threaded, through the eyelet of the suture anchor  110 . For example, three, four, five, or more sutures may be threaded through the eyelet of the suture anchor  110 , and the fixation plug may be engaged within the longitudinal hole of the suture anchor  110 , which may secure any suture disposed through the eyelet of the suture anchor  110  within the suture anchor  110 . Further, those having ordinary skill in the art will appreciate that the fixation plug may not necessarily need to have a threaded outer surface in order to engage with the suture anchor  110 . For example, in one or more embodiments, an outer diameter of the fixation plug may be substantially equal to, or slightly larger than, the diameter of the longitudinal hole formed in the suture anchor  110 . As such, in one or more embodiments, the fixation plug may be secured within, or engaged with, the suture anchor  110 , i.e., with the longitudinal hole of the suture anchor  110 , by disposing the fixation plug within the longitudinal hole of the suture anchor  110 . In one or more embodiments, frictional forces between the fixation plug and an inner surface of the longitudinal hole of the suture anchor  110  may engage with fixation plug within the longitudinal hole of the suture anchor  110  such that any sutures, e.g. the first suture  105  and the second suture  106 , that may be disposed through the eyelet may be secured within the suture anchor  110 . However, those having ordinary skill in the art will appreciate that a fixation plug may not be necessary in order to secure at least one suture within an eyelet of the suture anchor  110 . For example, in one or more embodiments, the eyelet may be formed near the distal end  112  of the suture anchor  110 , and the suture anchor  110  may be secured within a bone, e.g., the tibia  125 . As such, because the distal end  112  of the suture anchor  110  may be disposed within, and engaged with, the tibia  125 , the engagement between the outer surface of the suture anchor  110  and the hole formed in the tibia  125 , in which the suture anchor  110  is disposed, may secure at least one suture, e.g., the first suture  105  and the second suture  106 , within the eyelet of the suture anchor  110 . 
     Examples and further description of suture anchors and fixation plugs may be disclosed in co-pending U.S. application Ser. No. 12/259,106, titled “Anchor Assembly” and assigned to the assignee of the present disclosure, and hereby incorporated by reference in its entirety. 
       FIG. 2  shows one example of an anchor assembly  10 . The assembly  10  includes the anchor  20  and the insertion member  30 . The anchor  20  includes a proximal portion  21 , a distal portion  22 , and an inner cavity  23 . An opening  24  to the cavity  23  is located at the proximal portion  21  of the anchor  20 . A transverse through hole  25  is located between the proximal and distal portions  21 , 22  and extends through the anchor  20 . Openings  25   a,b  are located at each end of the through hole  25  Located below each opening  25   a,b  is a protrusion  26 . The protrusions  26  facilitate loading of a flexible member, such as a suture, through the through hole  25 , and allow for the creation of a path in the wall of a bone hole when the anchor  20  is inserted into bone hole. The outer surface  27  of the proximal portion  21  also includes barbs  28  for substantially reducing the possibility of removal of the anchor  20  when inserted into bone. The outer surface  27  also includes slots  29  extending from the openings  25   a,b  of the through hole  25  to the proximal portion  21  of the anchor  20 . The slots  29  intersect the barbs  28  and are configured for housing of the suture after positioning of the anchor  20  in bone. The cavity  23  extends into the through hole  25  and includes a proximal portion  23   a  and a threaded distal portion  23   b  for receipt of a fixation plug  30 . 
     The fixation plug  30  includes a body  31 , having a proximal end portion  31   a  and a flat distal end portion  31   b , and a head  32  coupled to the proximal end portion  31   a . The head  32  is configured for engagement with a delivery tool and the body  31  includes threads  31   c  that are configured for engagement with the threads  23   c  of the cavity  23  when the insertion member is arranged within the cavity  23 . 
     A method for meniscal repair, according to embodiments disclosed herein, may include providing a first tissue fixation member configured to secure a meniscal tissue, a suture anchor having an eyelet, and a first suture, securing the first suture to the first tissue fixation member. The method may also include making a single incision into a skin and forming a portal into a body and forming a hole within the bone, and engaging the first tissue fixation member and a delivery device and disposing the delivery device and the first tissue fixation member through the portal, into the body. Further, in one or more aspects, the method may also include engaging the second tissue fixation member and the delivery device and disposing the delivery device and the second tissue fixation member through the portal, into the body. 
     For example, referring to  FIG. 1A , the first tissue fixation member  101  and the second tissue fixation member  102  are configured to secure the meniscal tissue  130 . As shown, each of the first tissue fixation member  101  and the second tissue fixation member  102  were delivered through the meniscal tissue  130  with a delivery device  109 . In one or more embodiments, each of the first tissue fixation member  101  and the second tissue fixation member  102  may be secured to, or engaged with, the delivery device  109 . In one or more embodiments, the delivery device  109  may include a cannulated spinal needle and an obturator (not shown), e.g., a deployment rod (not shown). Further, in one or more embodiments, the delivery device  109  may be formed from any substantially rigid or from a flexible, biocompatible material known in the art. For example, the cannulated spinal needle of the delivery device  109  may be formed from biocompatible plastics, polymers, metals, and any combination thereof. In one or more embodiments, the cannulated spinal needle may be a 17 gauge spinal needle. However, those having ordinary skill in the art will appreciate that the cannulated spinal needle may not necessarily need to be a 17 gauge spinal needle. 
     Still referring to  FIG. 1A , as discussed above, each of the first tissue fixation member  101  and the second tissue fixation member  102  may include holes, or notches, formed therethrough, through which each of the first suture  105  and the second suture  106  may be engaged with, or coupled to, the first tissue fixation member  101  and the second tissue fixation member  102 , respectively. As such, according to one or more aspects, once the first suture  105  and the second suture  106  have been coupled to the first tissue fixation member  101  and the second tissue fixation member  102 , respectively, each of the first tissue fixation member  101  and the second tissue fixation member  102  may be disposed within the delivery device  109 , e.g., within the cannulated spinal needle (not shown). 
     Once a single incision into a skin, forming a portal (not shown) into a body, each of the first tissue fixation member  101  and the second tissue fixation member  102  may be disposed through the portal into the body with the delivery device  109 . According to one or more aspects, each of the first tissue fixation member  101  and the second tissue fixation member  102  may be engaged with, or secured to, the delivery device by disposing each of the first tissue fixation member  101  and the second tissue fixation member  102  within the delivery device. In one or more embodiments, an inner diameter of the cannulated spinal needle may be slightly larger than a diameter of the tissue fixation members  101 ,  102 . As such, according to one or more aspects, each of the first tissue fixation member  101  and the second tissue fixation member  102  may be disposed within, and received by, the cannulated spinal needle of the delivery device  109 . Further, a distal end of the cannulated spinal needle may be angled, such that the distal end of the cannulated spinal needle is configured to pierce the meniscal tissue  130 . 
     According to one or more aspects, the cannulated spinal needle of the delivery device  109  may be inserted through the portal, into the body, and may pierce through the meniscal tissue  130 . Once the cannulated spinal needle of the delivery device  109  has pierced the meniscal tissue  130 , the obturator may be disposed within the cannula of the cannulated spinal needle from a distal end of the cannulated spinal needle, and may force, or push, at least one of the first tissue fixation member  101  and the second tissue fixation member  102  out of the cannulated spinal needle, i.e., deploy at least one of the first tissue fixation member  101  and the second tissue fixation member  102  from the delivery device  109 . Upon deployment of at least one of the first tissue fixation member  101  and the second tissue fixation member  102 , the first tissue fixation member  101  and the second tissue fixation member  102  may be reoriented such that a longitudinal axis of the first tissue fixation member  101  and the second tissue fixation member  102  may be substantially parallel to a contacting surface of the meniscal tissue  130 . In other words, upon deployment of the first tissue fixation member  101  and the second tissue fixation member  102  from the delivery device  109 , the first tissue fixation member  101  and the second tissue fixation member  102  may be reoriented to prevent the first tissue fixation member  101  and the second tissue fixation member  102  from being displaced through the hole formed in the meniscal tissue  130  from the piercing of the cannulated spinal needle of the delivery device through the meniscal tissue  130 . 
     The method may also include securing the first tissue fixation member to a meniscal tissue, threading the first suture through the eyelet of the suture anchor, securing the suture anchor within a bone, and tensioning the first suture within the suture anchor. The method may also include securing a second suture to a second tissue fixation member, threading the second suture through the eyelet of the suture anchor, and tensioning the second suture within the suture anchor. 
     For example, referring to  FIG. 1B , each of the first tissue fixation member  101  and the second tissue fixation member  102  are secured to, or are engaged with, the meniscal tissue  130 . Further, as shown in  FIG. 1B , each of the first suture  105  and the second suture  106 , which are coupled to the first tissue fixation member  101  and the second tissue fixation member  102 , respectively, may be threaded, or disposed, through the eyelet (not shown) of the suture anchor  110 . 
     As shown in  FIG. 1C , the suture anchor  110  may be secured within the bone, e.g., within the tibia  125 . Further, each of the first suture  105  and the second suture  106  may be tensioned within the suture anchor  110  such that the area of the meniscal tissue  130  that is in contact with each of the first tissue fixation member  101  and the second tissue fixation member  102  may be pulled toward the suture anchor  110 , i.e., toward the tibia  125 . As discussed above, once each of the first suture  105  and the second suture  106  are tensioned, a fixation plug (not shown) may be engaged with the suture anchor to secure any sutures disposed through the eyelet of the suture anchor  110  within the suture anchor  110 . Furthermore, as discussed above, in one or more embodiments, three, four, five, or more tissue fixation members, that may be substantially identical to the first tissue fixation member  101  and the second tissue fixation member  102 , may be used in the assembly  100  to assist with securing the meniscal tissue  130 . For example, as shown in  FIG. 1C , a third tissue fixation member  103  may be used in the assembly  100  to assist with securing the meniscal tissue  130  to the tibia  125 . As shown, the third tissue fixation member  103  is coupled to a third suture  107 , which is also disposed through the eyelet of the suture anchor  110  and is secured within the suture anchor  110 . 
     The method may also include disengaging the first tissue fixation member from the delivery device and removing the delivery device from the body, and disengaging the second tissue fixation member from the delivery device and removing the delivery device from the body. For example, once all of the fixation members, e.g., the first tissue fixation member  101 , the second tissue fixation member  102 , and the third fixation member  103 , are deployed from the delivery device  109 , the delivery device  109  may be removed from the body, through the portal described above. 
     According to one or more aspects, the methods described herein may also be used for other surgical procedures pertaining to the meniscus. For example, according to one or more aspects, the methods described herein may be used to secure, specifically, the anterior horn of a meniscus tear. Further, according to one or more aspects, the methods described herein may be used for a meniscal transplant procedure. 
     A kit for meniscal repair, according to embodiments disclosed herein, may include at least one tissue fixation member configured to secure a meniscal tissue, a suture anchor comprising an eyelet, at least one suture configured to be coupled to the at least one tissue fixation member and configured to be received through the eyelet of the suture anchor, and a delivery device configured to assist with delivery of the at least one tissue fixation member into a body. 
     For example, in one or more embodiments, the kit for meniscal repair may include at least one of the first tissue fixation member  101 , the second tissue fixation member  102 , and the third tissue fixation member  103 , the suture anchor  110 , and at least one suture configured to be coupled to the at least one tissue fixation member and configured to be received through the eyelet of the suture anchor, e.g., sutures  105 ,  106 ,  107 . Further, in one or more embodiments, the kit for meniscal repair may include the delivery device  109  configured to assist with delivery of the at least one tissue fixation member into a body. As discussed above, the delivery device  109  may include a cannulated spinal needle and an obturator (not shown), e.g., a deployment rod (not shown), configured to assist with deployment of the tissue fixation members. 
     Advantageously, embodiments disclosed herein may provide an assembly for meniscal repair that reduces the difficulties and time to repair the meniscus. The aspects of the invention, discussed above, may allow endoscopic meniscal repair to virtually any area of the meniscus and may minimize the danger to neurovascular structures and the need for additional ancillary incisions. 
     While embodiments have been described with respect to a limited number of embodiments, those skilled in the art, having benefit of this disclosure, will appreciate that other embodiments can be devised which do not depart from the scope of embodiments disclosed herein. Accordingly, the scope of embodiments disclosed herein should be limited only by the attached claims.

Technology Classification (CPC): 0