Patent Publication Number: US-2021161647-A1

Title: Tenodesis fixation device

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application claims priority to U.S. Provisional Patent Application Ser. No. 62/717,013, filed on Aug. 10, 2018 and entitled “Tenodesis Fixation Device.” 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention is directed generally to a surgical system and, more particularly, to an implant and driver for fixing soft tissue in a desired position relative to bone. 
     2. Description of Related Art 
     There are several medical procedures where a surgeon needs to attach soft tissue such as tendons or other soft connective tissue to bone. One common example is a torn rotator cuff, where the supraspinatus tendon has separated from the humerus causing pain and loss of ability to elevate and externally rotate the arm. To repair a torn rotator cuff, typically a surgical procedure is used to suture the torn tendon to the bone using a variety of methods. Some procedures utilize large incisions and involve complete detachment of the deltoid muscle from the acromion. Small diameter holes are made in the bone for passing suture material through the bone to secure the tendon. Such large incision procedures are traumatic, causing prolonged pain and recovery time. Other procedures make small incisions and use arthroscopic techniques to attach sutures using either small diameter holes or a bendable tine. Other injuries requiring similar techniques include biceps tendonitis (e.g., a biceps tenodesis procedure) and a torn ACL. Additionally, there are augmentation procedures, such as Lateral Extraarticular Tenodesis, that require the placement of a bone tunnel adjacent to other bone tunnel(s). In these instances, it is preferable to have shallower anchor devices to prevent convergence of the tunnels. 
     Currently, there are various staple and anchor devices for attaching soft tissue to bone. However, many of these devices suffer from low pull-out strength, a lack of adequate suture attachment sites, a requirement to tie complicated knots with the sutures, complicated threading routines, a failure to assist the surgeon in positioning soft tissue into contact with bone prior to suturing to maximize bonding of the soft tissue to bone, and an overall difficulty in physically handling the devices during surgery. 
     Generally, injury to joints such as the shoulder and knee involve the tearing or separation of ligaments from their natural position on the bone. The injury leads to a chronic instability in the joint which requires surgical intervention. Modernly, the surgery involves use of one or more arthroscopic devices. These devices include surgical cannulas through which a camera or surgical device are passed. The arthroscopic methods usually involve reduced trauma to the patient than previous methods and can predict a faster recovery. 
     In brief, the surgical procedures involve visualization and localization of the damage, preparation of the bone surface, implantation of a soft tissue anchor, and suturing of the tissue to the anchor. By tightly contacting the ligament or other soft tissue to a properly prepared bone surface, the two materials bond during the healing process. 
     Fixation devices are commonly employed during such surgical procedures to secure the soft tissue to bone. The fixation device, such as an implant, is generally inserted into a prepared bone socket so that suture may extend out of the bone socket for stitching to the soft tissue. Drivers are used to insert and impact the implant in the bone socket. Traditional drivers may cause damage to the implant by the impact force. Further, some drivers do not have a mechanism that can be used to organize and tension suture. Therefore, the surgical procedure can take additional time. 
     Therefore, there is a need for an implant for securely grabbing onto the soft tissue graft for insertion into the prepared bone socket and a driver for inserting and impacting the implant into the prepared bone socket. 
     Description of the Related Art Section Disclaimer: To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section or elsewhere in this disclosure, these discussions should not be taken as an admission that the discussed patents/publications/products are prior art for patent law purposes. For example, some or all of the discussed patents/publications/products may not be sufficiently early in time, may not reflect subject matter developed early enough in time and/or may not be sufficiently enabling so as to amount to prior art for patent law purposes. To the extent that specific patents/publications/products are discussed above in this Description of the Related Art Section and/or throughout the application, the descriptions/disclosures of which are all hereby incorporated by reference into this document in their respective entirety(ies). 
     SUMMARY OF THE INVENTION 
     Embodiments of the present invention are directed to a surgical fixation device and driver for fixing soft tissue in a desired position relative to bone. According to one aspect, the present invention is a surgical fixation device. The fixation device includes a pronged upper portion having two or more arms extending proximally therefrom to a top surface of the upper portion. Each of the two or more arms comprises a side of the upper portion. The sides of at least two of the two or more arms are opposing sides. A flange extends outwardly around each of the opposing sides. The fixation device also includes a pronged lower portion having two or more legs extending distally therefrom and there is a space between at least two of the two or more legs. 
     According to another aspect, the fixation device may include a pronged lower portion having two or more legs extending distally therefrom with a space between at least two of the two or more legs. The fixation device may also include an upper portion having a top surface and two or more sides. At least two of the two or more sides have a first slot extending therebetween. Additionally, the fixation device has a central aperture extending into the top surface of the upper portion and through the lower portion. 
     According to yet another aspect, the present invention is a surgical driver. The driver has a handle having a body with a shaft extending distally therefrom. A driver interface at a distal end of the shaft is configured for attachment to a fixation device. The driver also includes a rotatable adjustment mechanism within the body of the handle. 
     These and other aspects of the invention will be apparent from and elucidated with reference to the embodiment(s) described hereinafter. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       One or more aspects of the present invention are particularly pointed out and distinctly claimed as examples in the claims at the conclusion of the specification. The foregoing and other objects, features, and advantages of the invention are apparent from the following description taken in conjunction with the accompanying drawings in which: 
         FIG. 1  is a side view schematic representation of a fixation device, according to an embodiment; 
         FIG. 2  is a top view schematic representation of the fixation device, according to an embodiment 
         FIG. 3  is a perspective view schematic representation of the fixation device in use in a pre-deployment configuration, according to an embodiment; 
         FIG. 4  is a perspective view schematic representation of the fixation device in use in a deployed configuration, according to an embodiment; 
         FIG. 5  is a cross-sectional side view schematic representation of the fixation device in use in the deployed configuration, according to an embodiment; 
         FIG. 6  is a top view schematic representation of a fixation device, according to an alternative embodiment; 
         FIG. 7A  is a perspective view schematic representation of a press-fit driver interface, according to an embodiment; 
         FIG. 7B  is a perspective view schematic representation of a threaded driver interface, according to an embodiment; 
         FIG. 7C  is a perspective view schematic representation of a slotted driver interface, according to an embodiment; 
         FIG. 7D  is a perspective view schematic representation of a keyed driver interface, according to an embodiment; 
         FIG. 8  is a side view schematic representation of a fixation device, according to an alternative embodiment; 
         FIG. 9  is a front view schematic representation of the fixation device of  FIG. 8 ; 
         FIG. 10  is a top view schematic representation of the fixation device of  FIG. 8 ; 
         FIG. 11  is a side perspective view schematic representation of a driver, according to an embodiment; 
         FIG. 12  is a perspective view schematic representation of the driver of  FIG. 11  loaded with the fixation device, according to an embodiment; 
         FIG. 13  is a partial exploded view schematic representation of the adjustment mechanism of the driver of  FIG. 11 , according to an embodiment; 
         FIG. 14  is a top perspective view schematic representation of the distal end of the handle of the driver, according to an embodiment; 
         FIG. 15  is a top view schematic representation of the spooling wheel, according to an embodiment; 
         FIG. 16  is a side view schematic representation of the spooling wheel, according to an embodiment; 
         FIG. 17  is a top perspective view schematic representation of the cover on the handle of the driver in a closed position, according to an embodiment; 
         FIG. 18  is a top perspective view schematic representation of the cover on the handle of the driver of  FIG. 17  in an open position, according to an embodiment; 
         FIG. 19  is a top perspective view schematic representation of the cover on the handle of the driver in a closed position, according to an alternative embodiment; and 
         FIG. 20  is a top perspective view schematic representation of the cover on the handle of the driver of  FIG. 19  in an open position, according to an alternative embodiment. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Aspects of the present invention and certain features, advantages, and details thereof, are explained more fully below with reference to the non-limiting examples illustrated in the accompanying drawings. Descriptions of well-known structures are omitted so as not to unnecessarily obscure the invention in detail. It should be understood, however, that the detailed description and the specific non-limiting examples, while indicating aspects of the invention, are given by way of illustration only, and are not by way of limitation. Various substitutions, modifications, additions, and/or arrangements, within the spirit and/or scope of the underlying inventive concepts will be apparent to those skilled in the art from this disclosure. 
     Referring now to the figures, wherein like reference numerals refer to like parts throughout,  FIG. 1  shows a side view schematic representation of a fixation device  100 , according to an embodiment. The fixation device  100  is a solid surgical implant. The fixation device  100  may be composed of metallic and/or polymeric material. The fixation device  100  comprises an upper portion  102  and a lower portion  101 . The upper portion  102  is wider than the lower portion  101  because the lower portion  101  is sized and configured to be inserted into a prepared bone socket. 
     As shown in  FIG. 1 , the lower portion  101  is pronged such that a plurality of legs  104  extend therefrom. In the depicted embodiment, the lower portion  101  comprises two legs  104 . Each of the plurality of legs  104  terminate in a sharp edge  105 . The sharp edges  105  aid the fixation device  100  in grabbing onto the prepared bone socket. As the lower portion  101  is pronged, a space  106  exists between at least two of the plurality of legs  104 . The space  106  is sized and configured to accommodate soft tissue. 
     Still referring to  FIG. 1 , the upper portion  102  of the fixation device  100  is also pronged such that a plurality of arms  108  extend therefrom. In the depicted embodiment, the upper portion  102  comprises two arms  108 . Each of the plurality of arms  108  comprises an outer flange  107 . The flange  107  is under a top surface  109  of the upper portion  102 . In other words, the flange  107  is between the top surface  109  and the lower portion  101 . In an embodiment, the flange  107  is a few millimeters from the top surface  109  to provide fixation under the dense cortical layer of bone. 
     Turning now to  FIG. 2 , there is shown a top view schematic representation of the fixation device  100 , according to an embodiment. As shown in  FIG. 2 , the flanges  107  extend outward from the arms  108 . The fixation device  100  additionally comprises one or more material reliefs  110  in the upper portion  102 . In the depicted embodiment, the fixation device  100  comprises two reliefs  110  and the reliefs  110  are on opposing sides  112 ,  114  of the fixation device  100 . With the reliefs  110  on opposing sides  112 ,  114  of the fixation device  100 , soft tissue is allowed to traverse down one side  112 , then under the space  106  ( FIG. 1 ), and back up the opposing side  114 . 
     Referring now to  FIGS. 3-5 , there are shown various perspective and side views schematic representations of the fixation device  100  in use, according to an embodiment. Prior to use of the fixation device  100 , an appropriately sized socket  201  is prepared in a bone  200 . Thereafter, the fixation device  100  is loaded over soft tissue  203  and positioned above the prepared bone socket  201 , as shown in  FIG. 3 . The soft tissue  203  is within the space  106  between the legs  104  of the lower portion  101  of the fixation device  100 . Note, the lower portion  101  has is sized and configured to fit within the prepared bone socket  201 . The sides  112 ,  114  of the upper portion  102  of the fixation device  100  are relieved slightly (via the reliefs  110  in  FIG. 2 ) to allow the fixation device  100  to extend out of the prepared bone socket  201 , but provide compression once fixated. 
       FIG. 4  shows the fixation device  100  impacted into the prepared bone socket  201 . As the upper portion  102  of the fixation device  100  is impacted into the prepared bone socket  201 , the upper portion  102  is compressed. Compression causes rotation of the legs  104  outwardly about the soft tissue  203  (like a fulcrum), as shown in  FIG. 5 . Outward deformation of the legs  104  allows for anchoring of the fixation device  100  within the prepared bone socket  201 . As described above, the sharp edge  105  of each leg  104  catches on the prepared bone socket  201 , aiding in the anchoring. 
     Turning now to  FIG. 6 , there is shown a top view schematic representation of a fixation device  100 , according to an alternative embodiment. In the embodiment of the fixation device  100  shown in  FIG. 6 , the top surface  109  of the upper portion  102  comprises a connection feature  116  sized and configured to interface with a driver  10  ( FIGS. 7A-7D ). In one embodiment, the connection feature  116  is an aperture. When the connection feature  116  is an aperture, the fixation device  100  can interface with a variety of driver interfaces  12  at a distal end  14  of the driver  10 , as shown in  FIGS. 7A-7D . 
     The driver interface  12  shown in  FIG. 7A  is a press-fit attachment which is sized and configured to fit within the aperture  116 . The driver interface  12  shown in  FIG. 7B  is a threaded attachment which is also sized and configured to fit within the aperture  116 ; however, the aperture  116  has complimentary threads (not shown).  FIG. 7D  shows a driver interface  12  that is a keyed attachment sized and configured to engagement the connection feature  116  shown in  FIG. 6 . The connection feature  116  shown in  FIG. 6  is an aperture  116  and an elongated recess  118  extending across the top surface  109  of the upper portion  102 , through the aperture  116 . The driver interface  12  in  FIG. 7D  is sized and configured to fit within the aperture  116  and the elongated recess  118 . Turning now to  FIG. 7C , the driver interface  12  is slotted or includes a slotted attachment comprising one or more slots  16  extending along the distal end  14  of the driver  10 . The driver  10  with slots  16  is preferably used with suture (not shown), as described in detail below. 
     Referring now to  FIGS. 8-10 , there are shown various view schematic representations of the fixation device  100 , according to an alternative embodiment.  FIGS. 8 and 9  show side and front views schematic representations of the fixation device  100 . The fixation device  100  comprises one or more ribs  120  extending across the sides  112 ,  114  of the upper portion  102 . The ribs  120  increase surface contact area and drag on the fixation device  100 . Further, the ribs  120  increase load sharing on the bone and accommodate varying cortical thickness. In the depicted embodiment, at least one of the ribs extends in a plan that is substantially parallel to the top surface  109  of the upper portion  102 . 
       FIG. 10  shows a top view schematic representation of the fixation device  100 . The upper portion  102  comprises one or more relief slots  122 . In the embodiment shown in  FIG. 10 , the top surface  109  of the upper portion  102  has two relief slots  122 . The two relief slots  122  are on opposing sides of the aperture  116 . As shown in  FIG. 10 , the relief slots  122  are configured radially around the aperture  116  to optimize wall thickness of the driver interface  12 , accommodating a larger driver interface  16  (e.g.,  FIG. 7D ). This, in turn, provides sufficient clearance for the inclusion of sutures through the central aperture  116 , while maintaining sufficient strength of the driver interface  12 . 
     Turning now to  FIGS. 11-20 , there are shown various views schematic representations of a driver  10  and components thereof, according to an embodiment.  FIG. 11  shows a side perspective view schematic representation of a driver  10  sized and configured for impacting the fixation device  100  in a prepared bone socket  201  ( FIGS. 3-5 ) of a defined diameter and depth. The driver  10  comprises a proximal end  18  and a distal end  14 . The proximal end  18  comprises a handle  20  connected to a shaft  22  which extends from the handle  20  to the distal end  14 . The shaft  22  allows axial impaction for inserting the fixation device  100 . The handle  20  can be curved and ergonomically shaped for comfortable use. 
     As shown in  FIG. 11 , the shaft  22  extends to a stop  24  at the distal end  14 . In the depicted embodiment, the stop  24  is a positive stop sized and configured to be employed at a predetermined location relative to the fixation device  100 . The positive stop  24  controls the insertion depth of the fixation device  100  to ensure that the top surface  109  of the fixation device  100  is relatively flush with the outer cortical layer of the bone. As also shown in  FIG. 11 , the positive stop  24  is comprised of a flexible member, such as an O-ring. In the depicted embodiment, the positive stop  24  is an O-ring with an outer diameter that is greater than an outer diameter of the shaft  22 . The O-ring serves as an indicator as to when proper anchor insertion depth has been achieved, while preventing damage to the cortex as the driver  10  is impacted against the bone. 
       FIG. 12  shows a perspective view schematic representation of a driver  10 , according to an alternative embodiment. In the depicted embodiment, the fixation device  100  is attached to the distal end  14  of the driver  10 . The fixation device  100  has one or more sutures  300  threaded or otherwise attached thereto for capturing soft tissue, stitching soft tissue to the fixation device  100 , or tying a portion of a fixated tendon over the top surface  109  of the upper portion  102  of the fixation device  100 . The driver  10  may also comprise one or more slots  26  along at least a portion of the length of the shaft  22  (see slots  16  in  FIG. 7D ). In  FIG. 12 , the driver  10  has two slots  26 . The two slots  26  extend along at least a portion of the shaft  22  on opposing sides of the driver  10 . Specifically, the slots  26  shown in  FIG. 12  are substantially aligned with the sides  112 ,  114  of the fixation device  100 . 
     Still referring to  FIG. 12 , the slots are sized and configured to receive suture  300 . The suture  300  extends from the lower portion  101  of the fixation device  100 . In particular, the suture  300  is folded to create a distal loop  302  with two limbs  304 ,  306  extending proximally therefrom. The distal loop  302  extends from the lower portion  101  and the two limbs  304 ,  306  extend through the fixation device  100 , then out through the aperture  116  ( FIG. 10 ), and exit the driver  10  through the slots  26 , as shown in  FIG. 12 . Thus, the limbs  304 ,  306  can freely travel within the space  106  in the fixation device  100  and along the shaft  22 . In an embodiment, the limbs  304 ,  306  are collected and tensioned at an adjustment mechanism  28  at the handle  20 . 
     Turning now to  FIG. 13 , there is shown a partial exploded view schematic representation of the adjustment mechanism  28  of the driver  10 , according to an embodiment. The adjustment mechanism  28  in the handle  20  of the driver  10  is rotatable. In particular, the adjustment mechanism  28  is a spooling wheel  30  within a cavity  32  in the handle  20 , as shown in  FIG. 13 . The limbs  304 ,  306  of suture  300  extend along the shaft  22  and are coupled to the adjustment mechanism  28  (spooling wheel  30 ), as shown in  FIG. 12 . The spooling wheel  30  can be rotated clockwise to increase the size of the distal loop  302  and counterclockwise to decrease the size of the distal loop  302  (or vice versa). Thus, the adjustment mechanism  28  serves to adjust the size of the distal loop  302 . 
     Turning now to  FIGS. 14-16 , there are shown various views schematic representations of adjustment mechanism  28  of the handle  20 , according to an embodiment.  FIG. 14  shows a close-up top view schematic representation of the adjustment mechanism  28  of the handle  20 . As shown in  FIG. 14 , a distal end  34  of the handle  20  comprises a slot  36  in a body  21  of the handle  20 . The slot  36  begins at or near the distal end  34  of the handle  20  and extends to the adjustment mechanism  28 . In some cases, the slot  36  extends to the cavity  32  in the handle  20 . The slot  36  allows the suture  300  (and in some cases, needles attached thereto) to separate from the handle  20 . 
       FIG. 15  shows a top view schematic representation of the spooling wheel  30  and  FIG. 16  shows a side view schematic representation of the spooling wheel  30 . The spooling wheel  30  comprises a slot  38 . The slot  38  extends through a top surface  40  of the spooling wheel  30 , as shown in  FIGS. 15 and 16 . The slot  38  allows the suture  300  to travel around a central hub  42  ( FIG. 15 ) of the spooling wheel  30 . The slot  38  also allows the suture  300  to wrap around the spooling wheel  30  and release from the spooling wheel  30 . 
     Referring now to  FIGS. 17-20 , there are shown multiple top perspective views schematic representations of the handle  20  of the driver  10 , according to an embodiment.  FIGS. 17 and 18  show top perspective views of the handle  20  of the driver  10  having a flip (or rotatable) cover  44 . As shown in  FIG. 17 , the handle  20  comprises a cover  44  that, in a closed position, is flush with a body  21  of the handle  20 . In an open position, as shown in  FIG. 18 , the cover  44  is rotates in a direction away from the body  21  of the handle  20 , exposing a compartment  46  within the handle  20 . The compartment  46  extends into the body  21  of the handle  20 . In the depicted embodiment, the cover  44  is rectangular, although any suitable geometry can be used. The compartment  46  is sized and configured to house or otherwise contain needles (not shown) for stitching suture  300 . Needles are often attached to the ends of the limbs  304 ,  306  of suture  300  to facilitate the ability to stitch the suture  300  to additional soft tissue for fixation to the fixation device  100 . 
       FIGS. 19 and 20  show top perspective views of the handle  20  of the driver  10  having a slide cover  44 . As shown in  FIG. 19 , the handle  20  comprises a proximal cover  44  that, in a closed position, is flush with a body  21  of the handle  20 . In an open position, as shown in  FIG. 20 , the cover  44  slides in the proximal direction away from the body  21  of the handle  20 , exposing a compartment  46  within the handle  20 . The compartment  46  extends into the body  21  of the handle  20 . In the depicted embodiment, the cover  44  is rectangular, although any suitable geometry can be used. The compartment  46  shown in  FIGS. 19 and 20  is sized and configured to store needles for the reasons stated above. The compartment  46  is a safe place to store needles as the compartment  46  is away from the user&#39;s hand during insertion of the fixation device  100 . 
     All definitions, as defined and used herein, should be understood to control over dictionary definitions, definitions in documents incorporated by reference, and/or ordinary meanings of the defined terms. 
     While various embodiments have been described and illustrated herein, those of ordinary skill in the art will readily envision a variety of other means and/or structures for performing the function and/or obtaining the results and/or one or more of the advantages described herein, and each of such variations and/or modifications is deemed to be within the scope of the embodiments described herein. More generally, those skilled in the art will readily appreciate that all parameters, dimensions, materials, and configurations described herein are meant to be exemplary and that the actual parameters, dimensions, materials, and/or configurations will depend upon the specific application or applications for which the teachings is/are used. Those skilled in the art will recognize, or be able to ascertain using no more than routine experimentation, many equivalents to the specific embodiments described herein. It is, therefore, to be understood that the foregoing embodiments are presented by way of example only and that, within the scope of the appended claims and equivalents thereto, embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure are directed to each individual feature, system, article, material, kit, and/or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and/or methods, if such features, systems, articles, materials, kits, and/or methods are not mutually inconsistent, is included within the scope of the present disclosure. 
     The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprise” (and any form of comprise, such as “comprises” and “comprising”), “have” (and any form of have, such as, “has” and “having”), “include” (and any form of include, such as “includes” and “including”), and “contain” (any form of contain, such as “contains” and “containing”) are open-ended linking verbs. As a result, a method or device that “comprises”, “has”, “includes” or “contains” one or more steps or elements. Likewise, a step of method or an element of a device that “comprises”, “has”, “includes” or “contains” one or more features possesses those one or more features, but is not limited to possessing only those one or more features. Furthermore, a device or structure that is configured in a certain way is configured in at least that way, but may also be configured in ways that are not listed. 
     The corresponding structures, materials, acts and equivalents of all means or step plus function elements in the claims below, if any, are intended to include any structure, material or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of one or more aspects of the invention and the practical application, and to enable others of ordinary skill in the art to understand one or more aspects of the present invention for various embodiments with various modifications as are suited to the particular use contemplated.