• 专利附录
  • 专利说明
  • 权利要求
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    • 专利摘要:
    ANCHOR IMPLANTS FOR BICEPS TENODESIS. The present invention describes various bone anchor assemblies and methods for anchoring tissue to bone. In one embodiment, an anchor assembly for anchoring a tendon to bone is provided that includes a substantially cylindrical sheath with bone engaging surface elements formed on an outer surface thereof and with an inner lumen formed therein and extending to from an open proximal end to a substantially closed distal end. The substantially closed distal end includes at least one tendon anchoring member extending distally therefrom and configured to facilitate anchoring of a tendon to bone. The anchor assembly further includes an expander with a generally elongated cylindrical configuration and is sized and shaped to be received within the inner lumen of the sheath.
    公开号:BR102015026658B1
    申请号:R102015026658-8
    申请日:2015-10-21
    公开日:2022-01-11
    发明作者:David R. Diduch；Mark H. Getelman；James J. Mahoney；Jacob A. Marks；Gerome Miller；Matthew J. Ravenscroft；Mehmet Z. Sengun；Howard C. Tang；Paul P. Weitzel；Gregory R. Whittaker
    申请人:Depuy Synthes Products, Inc；
    IPC主号:
    专利说明:

    CROSS REFERENCE FOR RELATED DEPOSIT REQUESTS
    [0001] This application claims priority from US patent application No. 62/067,701, filed on Thursday, October 23, 2014 and entitled "Biceps Tenodesis Implants and Delivery Devices", the disclosure of which is incorporated herein in its entirety, by way of reference. FIELD OF THE INVENTION
    [0002] Surgical devices and methods are provided for anchoring tissue to bone, and more particularly, surgical implants and methods are provided for securing a biceps tendon to the humerus. BACKGROUND
    [0003] Disorders of the long head of the biceps tendon are a common source of shoulder pain and may occur in association with other diagnoses such as rotator cuff tears, anteroposterior superior labrum tears, impingement syndrome and capsular injuries or may be present as an isolated source of shoulder pain. Treatment options for long head biceps (CLB) disorders continue to evolve and may include CLB tenodesis. In a tenodesis procedure, the suture is passed through the base of the CLB to locate the CLB in the subacromial space and to provide proximal control during dissection. When the suture is made, the CLB is cut close to the glenoid junction. A gauge can be used to measure the size of the tendon and thus determine an appropriately sized bone screw. When the screw is selected, a hole in the bone is drilled and a tendon fork is then used to push the tendon into the hole in the bone. A bone screw is then inserted into the bone hole to anchor the tendon within the bone hole.
    [0004] While current procedures can provide an effective means of anchoring the tendon to a bone, they can suffer from several disadvantages. For example, actual screws are rotated over the insert into a bone hole. Such rotation of the screw in relation to the tendon can lead to injury, laceration, severing or misalignment of the tendon. This misalignment can alter the desired tension and positioning of the tendon, leading to cramps, discomfort, and anatomic asymmetry. In addition, it may be difficult to achieve a desired implant depth relative to the hole.
    [0005] Consequently, there is a need for improved tissue anchoring devices and methods, and in particular, anchoring and methods for use in a procedure for biceps tenodesis. SUMMARY
    [0006] The present disclosure describes various bone anchor assemblies and methods for anchoring tissue to bone. In one embodiment, an anchor assembly for anchoring a tendon to bone is provided that includes a substantially cylindrical sheath with bone engaging surface elements formed on an outer surface thereof and with an inner lumen formed therein and extending to from an open proximal end to a substantially closed distal end. The substantially closed distal end includes at least one tendon anchoring member extending distally therefrom and configured to facilitate anchoring of a tendon to bone. The anchor assembly further includes an expander with a generally elongated cylindrical configuration and is sized and shaped to be received within the inner lumen of the sheath. The expander may have a lumen extending at least partially therethrough to receive a guidewire.
    [0007] The tendon anchor element can have a variety of configurations. In one embodiment, the tendon anchor may be at least one pin extending distally from a distal face surface of the sheath. For example, the first and second pins can extend distally from a distal face surface of the sheath and the pins can extend substantially parallel to each other. In another embodiment, a first, second and third pin may extend distally from a distal face surface of the sheath. The pin(s) may have a rounded or pointed tip configuration. By way of non-limiting example, the pins may be in the form of short or long stakes, cones, rounded rods, pointed or rounded cylindrical rods, barbed members, etc. In another embodiment, the at least one tendon anchor may be in the form of first and second flaps extending distally from opposite side walls of the sheath. The tabs can define a generally U-shaped recess with each other. In other aspects, the at least one tendon anchoring element may be a semicircular hook or an arc having an opening formed therethrough to receive a tendon.
    [0008] The hems can also have a variety of configurations. In one embodiment, the open proximal end of the sheath may include opposing flanges extending radially outward therefrom and configured to limit an insertion depth of the sheath into a bone hole. Alternatively, the open proximal end of the sheath may include at least one tab extending radially outward therefrom and configured to rest against a surface of bone when the sheath is implanted into a hole in the bone. The sheath may include other features such as sidewall grooves or slots, internal threads, etc. The expander can also have a variety of configurations and in one embodiment the expander can be threaded to threadably fit with threads formed within the sheath. In other aspects, the sheath may include at least one rib formed on the outer surface and extending longitudinally in a proximal-distal direction. The expander can also have various configurations. For example, the expander may include a flange extending radially outward from a proximal end thereof.
    [0009] In another embodiment, an anchor assembly for anchoring a tendon to a bone is provided and includes a sheath having a body with at least two side walls extending proximally therefrom. The side walls may define an inner lumen therebetween, and the side walls may have threads formed on an inner surface thereof. The sheath may further include a tendon engaging member extending distally from a maximal distal surface thereof. The tendon engaging member may be configured to engage and secure a tendon within a bone hole. The anchor assembly may also include a thread expander configured to be received between the pair of side walls and to threadably engage with the threads formed on the inner surface of the side walls. The threaded sheath and expander can be configured so that when the expander is fully threaded into the sheath, the sheath expands radially outward to secure a tendon within a bone hole due to compression.
    [00010] As indicated above, the tendon engagement element may have a variety of configurations and may be in the form of two pins spaced relative to each other, collapsible pins configured to move radially inward toward each other to engage the tendon therebetween, first and second extension flaps extending distally from opposite side walls of the sheath and defining a generally U-shaped recess therebetween, a hook-shaped member, an arch with an opening therein for receive a tendon etc.
    [00011] In other aspects, a method for anchoring a tendon to a bone is provided and includes manipulating a sheath to engage a tendon with a tendon engaging element extending distally from a distal end of the sheath, inserting the sheath with the tendon conjugated to the tendon engaging element into a bone hole so that the tendon extends around the sheath, and inserting an expander into the sheath to cause the sheath to expand radially outward to thereby anchor the sheath. tendon and sheath into the bone hole. In one embodiment, the tendon engaging element may be in the form of pins that penetrate through the tendon to couple the tendon to the sheath. In another embodiment, the tendon engaging element may be in the form of tabs whereby the tendon is positioned between the tabs. In another embodiment, the tendon engaging element may be in the form of a hook to which the tendon is hooked.
    [00012] In another embodiment, a method for anchoring a tendon to a bone is provided and includes positioning a tendon through a bone hole and maintaining the tendon at a desired tension, positioning a sheath with a pair of coupling elements of the tendon extending distally from the sheath proximal to the tendon, manipulating the sheath to determine a point of engagement along the tendon at a distance from the bone hole, the distance being measured using a pair of tendon engagement elements, and engaging the tendon at the point of engagement with a pair of tendon engagement elements and inserting the sheath with a tendon attached thereto into the bone hole. In one embodiment, the distance may be substantially equal to the depth of the bone hole. In other respects, the distance can be measured by rotating the sheath to move the pins along the tendon. BRIEF DESCRIPTION OF THE DRAWINGS
    [00013] The invention will be more widely understood from the detailed description presented together with the attached drawings, in which:
    [00014] Figure 1 is a perspective view of an embodiment of a biceps tenodesis anchor assembly having a sheath and an expander;
    [00015] Figure 2 is a top perspective view of the sheath of Figure 1 and another embodiment of an expander;
    [00016] Figure 3 is a bottom perspective view of the sheath of Figure 1;
    [00017] Figure 4 is a side perspective view of another embodiment of the sheath;
    [00018] Figure 5 is a top perspective view of the sheath of Figures 1 to 3, shown anchoring a tendon within a bone hole;
    [00019] Figure 6 is a side perspective view of another embodiment of the sheath with a barbed shank;
    [00020] Figure 7 is a side view of another embodiment of a sheath having a distally long peg feature for engaging a tendon;
    [00021] Figure 8 is a side view of another embodiment of a sheath with a distally short wedge feature;
    [00022] Figure 9 is a side view of another embodiment of a sheath with a plurality of distal peg features;
    [00023] Figure 10A is a side view of another embodiment of a sheath with two distal stake features, shown nearly anchoring a tendon within a bone hole and receiving an expander to hold it in place;
    [00024] Figure 10B is a side view of the sheath and tendon of Figure 10A, shown inserted into the bone hole with the expander inserted therein;
    [00025] Figure 10C is a side view of another sheath embodiment with a pair of distal stake features shown measuring the distance along a tendon from a bone hole;
    [00026] Figure 10D is a side view of the sheath and tendon of Figure 10C, showing the sheath engaging the tendon;
    [00027] Figure 10E is a side view of the sheath and tendon of Figure 10D, shown about to be inserted into the bone orifice;
    [00028] Figure 11 is a side view of another embodiment of sheath with a distal barbed rod, shown anchoring a tendon within a bone hole;
    [00029] Figure 12 is a side view of another sheath modality with two rods, forming a feature disposed at the distal end thereof;
    [00030] Figure 13A is a side view of another sheath embodiment with flexible distal pins, shown engaging a tendon to be inserted into a bone orifice and to receive an expander;
    [00031] Figure 13B is a side view of the sheath and tendon of Figure 13A inserted into the bone hole, showing the flexible pins closed to tighten and secure the tendon;
    [00032] Figure 14A is a side view of another embodiment of a sheath with a distal hook;
    [00033] Figure 14B is a side and top view of the sheath of Figure 14A, showing the sheath aligning with the bone hole;
    [00034] Figure 15A is a side view of another embodiment of a sheath with a distal ring or arch for securing the tendon;
    [00035] Figure 15B is a top view of the sheath of Figure 15A showing the tendon passing through the ring or arch;
    [00036] Figure 16 is a side view of another embodiment of a sheath with a distal hook for engaging the tendon;
    [00037] Figure 17 is a side view of another embodiment of a sheath with a distal hook for engaging and securing the tendon;
    [00038] Figure 18 is a side view of the sheath of Figure 17 and a cross-sectional view of the bone, showing the sheath implanted in the bone;
    [00039] Figure 19A is a side view of another embodiment of a sheath with a pair of short, broadly rounded shanks forming forks extending distally therefrom;
    [00040] Figure 19B is a side view of another embodiment of a sheath with a pair of long, broadly rounded shanks forming forks extending distally therefrom;
    [00041] Figure 20A is a side perspective view of another embodiment of a sheath with opposing expansion slits and distal U-shaped channels for tendon engagement;
    [00042] Figure 20B is a side view of another embodiment of a sheath;
    [00043] Figure 21 is a side view of another embodiment of a sheath with a proximal retention feature;
    [00044] Figure 22A is a side view of another embodiment of a sheath with a proximal retention feature and a pair of opposing slits;
    [00045] Figure 22B is a top view of the sheath of Figure 22A;
    [00046] Figure 23A is a side perspective view of another embodiment of a sheath having concave side walls;
    [00047] Figure 23B is a top view of the sheath of Figure 23A;
    [00048] Figure 24A is a partially transparent side view of a sheath attached to a guidewire, showing the sheath about to insert the tendon into a bone hole;
    [00049] Figure 24B is a partially transparent side perspective view of the sheath, tendon and guidewire of Figure 24A disposed in the bone orifice;
    [00050] Figure 24C is a side view of the sheath, tendon and guidewire of Figure 24B, showing an expander about to be inserted into the sheath over the guidewire;
    [00051] Figure 24D is a side perspective view of the sheath, tendon and expander of Figure 24C with the guidewire removed therefrom;
    [00052] Figure 25A is a side view of another sheath embodiment with an expandable distal end, showing the sheath positioned around a tendon to insert the tendon into the bone and showing an expander being received in the sheath;
    [00053] Figure 25B is a top view of the sheath of Figure 25A;
    [00054] Figure 25C is a side view of the sheath and expander of Figure 25A, showing the sheath implanted in the bone and expanded to receive the tendon and anchor the sheath within the bone;
    [00055] Figure 25D is a perspective view of the sheath of Figure 25A; and
    [00056] Figure 25E is a cross-sectional view of the sheath and expander of Figure 25A. DETAILED DESCRIPTION
    [00057] Certain exemplifying modalities will now be described to provide a general understanding of the principles of structure, function, fabrication and use of the devices and methods disclosed herein. One or more examples of such embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described in the present invention and illustrated in the accompanying drawings are exemplary non-limiting embodiments and that the scope of the present invention is defined solely by the claims. Features illustrated or described in connection with one exemplary embodiment may be combined with features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
    [00058] Throughout this specification, the terms "several modalities", "some modalities", "a modality" or "the modality", or similar, mean that a specific element, structure or characteristic described together with the embodiment is included in at least one embodiment. Therefore, the appearance of the phrases "in several embodiments", "in some embodiments," "in one (1) embodiment," or "in one embodiment", or similar, in places from beginning to end of the specification are not necessarily all referring to the same modality. In addition, particular features, structures or features may be combined in any suitable manner in one or more modalities. Therefore, the particular features, structures or characteristics illustrated or described in conjunction with a modality may be combined, in whole or in part, with the structures of the features or characteristics of a or more other modalities, without limitation.
    [00059] It will be understood that the terms "proximal" and "distal" may be used throughout the specification with reference to a physician manipulating an end of an instrument used to treat a patient. The term "proximal" refers to the portion of the instrument closest to the physician and the term "distal" refers to the portion located furthest from the physician. It should also be noted that, for accuracy and clarity, spatial terms such as "vertical". "horizontal", "upwards" and "downwards" may be used in the present invention with respect to the illustrated embodiments. However, surgical instruments can be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
    [00060] In general, methods and devices are provided for anchoring tissue, such as a ligament or tendon, to a bone. In an exemplary embodiment, the methods and devices are used to perform biceps tenodesis surgery; however, one skilled in the art will understand that the devices and methods can be used in various procedures and for anchoring any tissue to a bone. In one embodiment, a surgical implant is provided having a sheath and an expander that is received within the sheath. The sheath may include a plurality of tendon engaging elements formed at a distal end thereof to assist in engaging and inserting the tendon into a bone hole. The sheath may also include several elements at the proximal end to compress the tendon against the bone, facilitating the introduction of the expander into the sheath, etc. The expander, when inserted into the sheath, can cause the sheath to expand radially outward, preferably in or below the cortical layer, thereby anchoring the sheath and tendon within the bone hole. One skilled in the art will understand that the surgical implants and methods disclosed in the present invention can be used with a variety of surgical devices, including insertion tools, targeting tools, measuring devices, drills, surgical hammers, etc. Several exemplifying tools are presented in US Patent Application No. [ ] entitled "Biceps Tenodesis Implants and Delivery Tools", and in US Patent Application No. [ ] entitled "Biceps Tenodesis Delivery Tools", each filed on the same date hereof. application and incorporated herein in full by reference.
    [00061] In general, several anchor sets are provided that include a sheath and an expander. The sheath can be of various configurations but, in general, is of an elongated substantially cylindrical shape with an internal lumen extending from an open proximal end to a closed distal end. Although the distal end is described as being closed, it may include a blind hole formed in an inner surface thereof to receive a guide wire, or it may include a hole extending completely therethrough to receive a guide wire. The outer surface of the sheath may include one or more bone engaging surface elements formed along distinct portions thereof, or along an entire length thereof. The inner surface of the sheath may include elements to mate with the expander, such as ribs or threads. As will be discussed in more detail below, the various sheath modalities may also include a distal tendon engaging element, such as one or more pins, hooks, rings, tabs, etc., for impaling, penetrating, holding, or otherwise engaging. a tendon to help push the tendon into a bone hole and/or to secure the tendon within the bone hole. The expander can also have a variety of configurations. For example, the expander may be in the form of a plug which may include one or more ribs that allow the expander to be snapped or snap-fitted into the sheath. Alternatively, the expander may be in the form of a threaded screw that threads into the sheath. The expander may also be a plug/screw combination where a distal portion is press fit into the sheath and a proximal portion is threaded into the sheath. One skilled in the art will understand that the sheath and expander can each have a variety of configurations and that any one or more of the various elements disclosed herein can be used in any combination to form a desired anchor assembly. Furthermore, the various anchor assemblies disclosed in the present invention may be formed of any biocompatible material, which may optionally be bioabsorbable. Sheath arrangements can also be flexible or formed from a material that can deform radially outwardly when the expander is received therein. One skilled in the art will understand that this can be achieved by varying the materials and/or thickness of the sheath walls.
    [00062] The devices and methods described in the present invention may have several advantages over existing techniques for performing biceps tenodesis surgery. In particular, the entire fixation preparation procedure can be objective and requires a surgeon to use only a few basic steps to secure the implant framework, including the sheath and expander, to the bone. For example, the external tendon sheath engaging elements can assist in inserting the tendon into the bone hole, maintaining proper tension on the tendon and anchoring the tendon properly. Additional tools to hold and submerge the tendon into the bone hole are not necessary. A risk of tendon damage during insertion of the tendon into a bone hole is also reduced as the sheath can be inserted into the bone hole without rotating the sheath. Since the expander is received within the sheath and does not come into direct contact with the tendon, no rotation of the expander into the sheath will cause any damage to the tendon. Consequently, a risk of causing trauma to the tendon can be reduced and the time required to prepare and fix the tendon can be significantly reduced, which can facilitate surgery and mitigate any inconvenience to the patient. In addition, the techniques described can help reduce operating room costs.
    [00063] Figures 1 to 3 illustrate a biceps tenodesis implant modality or anchor set that includes a sheath 10 and an expander, which is in the form of a screw 20. In general, the sheath 10 is configured to seat a tendon around it and to receive the expander screw 20 therein, which is capable of causing the sheath 10 to expand into the bone to anchor the tendon within a bone hole.
    [00064] Sheath 10 can have a variety of shapes and configurations. As shown, the sheath 10 has an elongated cylindrical shape with an open proximal end 10p having a proximal facing surface and a closed distal end 10d having a distal facing surface. Sheath 10 includes an internal lumen 12 extending from the open proximal end 10p and stopping almost proximate to the closed distal end 10d. As further shown, the sheath 10 has a substantially triangular cross-sectional geometry, which generally defines three side walls, as will be described below with reference to Figure 5. The cross-sectional shape may, however, vary and may be square, circular, , oval etc. The cross-sectional shape can also vary along its length. The inner surface of the sheath may include various elements to facilitate engagement with the expander, such as the screw 20. Although not shown, the inner lumen may include threads or ribs formed to engage the screw 20. The outer diameter of the sheath 10 may also be vary, but in an exemplary embodiment the outside diameter is substantially constant along a proximal portion of the sheath and tapers distally inwardly along a distal portion of the sheath, as shown. The distal and proximal face surfaces of the sheath 10 may also vary. In some embodiments, the proximal surface may be convex to match the contour of the bone and the distal surface may be concave or saddle-shaped to seat the tendon thereon.
    [00065] As indicated above, the sheath 10 is configured to receive the expansion screw 20 there and to expand and be anchored within the bone hole. In order to facilitate expansion, sheath 10 may include one or more exhaust channels 14 extending longitudinally along sheath 10 and configured to rupture to allow radial expansion of the sheath. In the illustrated embodiment, the sheath 10 includes two exhaust channels 14 (only one channel is shown) formed on opposite side walls therefrom, so that the sheath 10 can split in half. While the position of the grooves 14 around the circumference of the sheath may vary, in one exemplary embodiment the grooves are arranged to allow the sheath to separate and expand in the direction the tendon extends, as will be discussed in more detail below with in relation to Figure 5. In the illustrated embodiment, the exhaust channels 14 are positioned at a substantial midpoint of two of the three sides of the triangular cross-sectional shape. Exhaust channels 14 extend from proximal end 10p and stop almost near closed distal end 10d, as best shown in Figure 3 (only one exhaust channel is shown). Exhaust channels may be formed on the inner, outer, or both surfaces of the elongated body and may be in the form of a channel or groove that results in a thin-walled section of the sheath. In other embodiments, the exhaust channel may extend entirely through the sheath in certain regions, with the side walls being secured only in distinct locations.
    [00066] As further shown in Figures 1 to 3, the sheath 10 may also include bone engaging surface elements formed on an outer surface thereof. In the illustrated embodiment, the sheath includes a plurality of ribs 16 extending radially therefrom and spaced longitudinally along the proximal portion thereof. The distal portion of the sheath is free of elements. The ribs illustrated are uniplanar and do not form threads, as the sheath 10 is preferably non-rotatable during insertion into a bone hole. Although only three ribs 16 are shown, the hem can include any number of ribs. Each rib can have various cross-sectional geometries, including square, triangular, etc. The channels may also have a particular directional orientation to help engage the tendon. The sheath may also include one or more longitudinal ribs 18 extending in a proximal distal direction. These ribs can define a recess 17 between them to seat the tendon, thus allowing the tendon to wrap around the sheath 10. The position of the longitudinal ribs 18 can vary, but in an exemplary embodiment the ribs are formed at a location that positions the tendon in the desired orientation when seated in the bone hole, as will be discussed in detail below with reference to Figure 5. The radial ribs 16 may extend between the longitudinal ribs 18 so that the tendon will overlap the radial ribs 16.
    [00067] As shown further in Figures 1 to 3, the sheath 10 may include one or more distal tendon engaging elements to engage and/or manipulate the tendon during the insertion technique and/or to maintain the tendon's position after insertion. anchor implant insertion. In addition, the distal elements may continue to engage the tendon after the tendon is anchored within the bone hole. The elements can have various configurations, such as external ribs, a single distal tip or a plurality of distal tips, a circular or semicircular hook, guide fins, expansion tips, anchoring tips, tendon grips, etc. In this embodiment, the tendon engaging member is in the form of first and second pins 19 that extend distally from the distal face surface of the sheath 10. Each pin may have a generally elongated configuration with a rounded tip for impaling a tendon. without penetrating it, or with a pointed tip to penetrate the tendon. The tip may also include a head formed thereon to prevent the pin from pulling out of the tendon. The pins 19 may extend at various angles to one another, including substantially parallel to one another, as shown. The pins are preferably positioned at a distance apart from each other. Distance may vary depending on intended use. In the illustrated embodiment, the pins 19 are positioned within the outer perimeter at the distal end 10d of the sheath 10; however, the pins 19 are on opposite sides of the distal end of the sheath 10. As a result, the pins 19 will be spaced a distance that is less than the width of the tendon to be anchored so that the pins 19 can penetrate the tendon to engage and manipulate the tendon. In other embodiments, as will be discussed in more detail below, the pins may extend from the outer side walls of the sheath so as to allow a tendon to be received therebetween. The position of the pins in relation to the tendon will be discussed in more detail below in relation to Figure 5.
    [00068] As indicated above, the sheath 10 is configured to receive an expander, for example a screw 20. In the embodiment of Figure 1, the expansion screw 20 has an elongated generally cylindrical configuration with a constant minor diameter along at least a proximal portion and preferably over most of the length, for example more than half of the total length. In other embodiments, however, the bolt may be tapered along the entire length or portions thereof, or may be bullet-shaped. A distal portion of the expander may taper distally inward to reduce the diameter at the most distal end. The expander may have threads formed along and extending along the entire length to facilitate engagement with the sheath upon insertion. In some embodiments the threads may extend partially along the expander body. The height of the threads 22 may vary, for example the height may decrease towards the distal end to form a tapered distal tip. Such a configuration can facilitate insertion of expansion screw 20 into sheath 10. When fully inserted there, the proximal end 20p of the expander may sit parallel to the proximal end 10p of the sheath 10. Alternatively, the expander may be seated slightly elevated or slightly lowered, as desired. In another embodiment, shown in Figure 2, the expansion screw 120 may include a head 121 formed at the proximal end 120p thereof. The head may have an enlarged diameter compared to the rest of the screw. The diameter may also be greater than the maximum diameter of the proximal end 10p of the sheath 10. Such a configuration will allow the head to rest against a proximal end of the sheath 10 and will allow compression of the tendon between the head 121 and the bone surface. Each expansion screw can also be fully cannulated to allow the screw to be delivered over the guidewire. The screws may additionally have a flat proximal face surface and a flat distal face surface, or in other embodiments the shapes of the distal and proximal surfaces may vary. For example, the proximal surface may be convex to conform to the bone surface.
    [00069] In use, implant screws 400 and 420 are configured to be inserted into sheath 100, causing the sheath 100 to expand. In an exemplary embodiment, the threads Ht have a height that is less than the height of the grooves of the thread 426 formed in the sheath, thus allowing the smaller diameter D1 of the screw 420 to come into contact with the main diameter of the sheath 100 and thus causing expansion. of sheath 100. As a result, the threads are not sized to cause sheath 100 to expand, and instead the smaller diameter of screws 400 and 420 causes expansion. Additionally, the implant screw can be shaped to cause the thicker middle portion of the sheath to expand radially outward by a distance that is greater than the proximal and distal ends of the sheath, so that the middle portion forms the larger diameter of the sheath. sheath in the expanded state, as previously discussed in relation to Figure 2.
    [00070] One skilled in the art will understand that the sheath 10 and expansion screw 20 and 120 of Figures 1 to 3, as well as the remaining sheath and expansion modalities shown in the present invention, may include various other elements to facilitate implantation. in a bone hole. With reference to Figure 1 by way of a non-limiting example, the expansion screw 20 may include a driving socket, for example a hexagon socket 23 formed at the proximal end 20p thereof and configured to receive an element, for example a hexagonal element. in a driving tool. Sheath 10 may similarly include elements to facilitate insertion into a bone hole, such as a threaded hole formed in the inner surface of the solid distal end to fit into a threaded end of a guidewire, or any other driving element formed therein to fit with the driving tool.
    [00071] Figure 4 illustrates another embodiment of sheath 110 that is similar to sheath 10 in Figures 1 to 3 in that it has a generally triangular cross-sectional shape with three side walls along at least a proximal portion of the sheath. same. Other cross-sectional regions may be circular, or a combination of circular and triangular. In this embodiment, the sheath 110 does not have any radial or longitudinal rib formed therein; however, such elements can be included. Sheath 110, however, includes an anti-sink flange 113a formed therein, and a cortical retainer flange 113b formed therein. Anti-sink flange 113a extends radially outward from the most proximal end of sheath 110 and may have a diameter that is greater than the diameter of the bone hole so as to act as a lock to limit a depth of insertion of the sheath into the hole. of the bone. The anti-sink flange 113a may also function to compress a tendon against the surface of the bone to help prevent tendon slippage. The cortical attachment flange 113b is positioned a distance from the anti-sink flange and can be configured to expand beneath the surface of the cortical bone when the sheath is implanted to prevent the sheath from being pulled out. In particular, the cortical attachment flange 113b and the anti-sink flange 113a may be spaced apart to allow the full thickness, e.g. 1 to 2 mm, of cortical bone to be received therebetween. In other words, when the sheath is implanted and the anti-sink flange 113a remains on a surface of the bone, the cortical attachment flange 113b can extend beneath the cortical bone. The cortical attachment flange 113b may have a diameter that is smaller than the diameter of the anti-sink flange 113a, so that the cortical attachment flange 113b can pass into the bone hole. When the sheath 110 is expanded by the expansion screw, the cortical attachment flange 113b can expand radially beyond the opening in the cortical bone, thereby seating under the bone to prevent the sheath from being pulled out.
    [00072] To facilitate expansion of sheath 110, including cortical attachment flange 113b, sheath 110 may include longitudinal channels 114 (only one channel is shown) formed on opposite sides thereof. The channels 114 have a similar configuration to the channels 14 described above with reference to Figures 1 to 3. The location of the channels 114 is best shown in Figure 5, which illustrates the three side walls (a first side wall 111a, a second sidewall 111b and a third sidewall 111c), with groove 114a formed at a midpoint of the first sidewall 111a and a groove 114b formed at a midpoint of the second sidewall 111b. The sheath 110 of Figures 4 and 5 also includes first and second pins 119, similar to the pins 19 of Figures 1 to 3. In this embodiment, the pins 119 are of a longer length so that the pins are configured to extend entirely through of the tendon. One skilled in the art will understand that the length can be varied as desired. As shown in Figure 5, the pins are preferably aligned along a longitudinal axis A, with the first side wall 111a, the second side wall 111b and the channels 119a and 119b positioned on opposite sides of the axis A. The third side wall 111c extends substantially perpendicular to axis A. Such a configuration will allow the sheath 110 to separate in a direction substantially perpendicular to axis A, so that half of the first and second sidewalls 111a and 111b move toward the right side R of the tendon and the other half of the first and second sidewalls 111a and 111b together with the third sidewall 111c move towards the L side of the tendon. The side walls, when separated, will thus compress the tendon within the bone, thus facilitating the anchoring of the tendon within the bone orifice. The sheath of Figures 1 to 3 can also function in a similar way. A person skilled in the art will understand that the pins can be oriented in a parallel or perpendicular orientation in any of the embodiments presented in the present invention. For example, in the embodiment of Figure 5, the pins can be positioned on opposite sides of the longitudinal axis A.
    [00073] Figure 6 illustrates another embodiment of a sheath 210. In that embodiment, the sheath 210 has a generally circular cross-sectional geometry, rather than a triangular cross-sectional geometry. The general shape of the body is the same, with the proximal portion being substantially cylindrical with a constant diameter and the distal portion tapering distally inward. Sheath 210 is otherwise similar to sheath 10 of Figures 1 to 3 and includes radial ribs 216 and longitudinal ribs 218 along the proximal portion thereof, with the distal portion being free of surface elements. In that embodiment, the sheath 210 has four longitudinal ribs 218 spaced around the perimeter of the sheath 210. The sheath 210 also includes escape channels 214 similar to the channels of Figures 1 to 3. In this embodiment, the sheath 210 has two escape channels 214 positioned on opposite sides of the sheath 210 so that the sheath 210 when expanded will separate into two side walls, with two of the longitudinal ribs 218 positioned on one of the side walls to seat a tendon leg therebetween, and the other two longitudinal ribs being positioned on the other side wall to seat the other tendon leg between them. Sheath 210 also has first and second pins 219 which are similar to pins 19 described above with reference to Figures 1 to 3, however in this embodiment the pins are barbed so that they are configured to pierce and hold the tendon. The pins are also oriented to be positioned perpendicular to the longitudinal axis of a tendon, rather than parallel.
    [00074] As indicated above, the tendon engaging element at a distal end of the sheath can have a variety of other configurations. Figures 7 to 9 illustrate additional embodiments of sheaths having tendon engagement pins. In the embodiment of Figure 7, the sheath 310 has a single pin 319 which is positioned and thus stake-shaped to penetrate through a tendon, and which has a greater length, for example a length which is greater than the thickness of the tendon so as to allow pin 319 to extend completely through the tendon. Single pin 319 is positioned at a midpoint at the distal end of sheath 310. Figure 8 illustrates a similar sheath 410 with a single pin 419 in the form of a loop, however pin 419 is shortened in length such that the pin 419 only penetrate and grasp the tendon without completely extending the tendon. Figure 9 illustrates a sheath 510 having three peg-like pins 519 extending distally from the distal end of the sheath. Pins 519 are positioned in a triangular pattern and are closed together to allow all three pins 510 to penetrate the tendon. The pins are also longer in length, so they can extend completely through the tendon. One skilled in the art will understand that the sheath may include any number of pins having various lengths to inflict a desired amount of trauma to the tendon so as to allow the tendon to be engaged and moved and held by the sheath.
    [00075] The sheaths 310, 410 and 510 in Figures 7 to 9 each further include a proximal flange 313, 413 and 513 extending radially outward from a more proximal end thereof. The proximal flanges can each be configured to compress a tendon against an outer surface of the top of the bone to help anchor the tendon in position. Each flange 313, 413 and 513 may include one or more exhaust channels or cutouts formed therein and aligned with one or more exhaust channels or slots formed in the sheath to allow expansion of the sheath.
    [00076] Figures 10A to 10B illustrate a method of anchoring a tendon within a bone hole. While the method can be performed using any of the various sheaths and expanders disclosed herein, Figures 10A to 10B are depicted in connection with sheath 610 and expansion screw 620, which have a similar configuration to the sheath of Figures 7 to 9 and the expansion screw of Figure 1. In this embodiment, the sheath 610 includes a pair of shortened pins 619 in the form of pegs, positioned parallel to and extending distally from the distal surface of the sheath. Figure 10A illustrates a T tendon extending through a bone hole H. With the tendon held in a desired tension, pins 619 can be used to pierce the tendon at a location proximal to a lateral displacement of the bone hole, as indicated by the arrow. The tendon is pierced at a closer location so as to account for the depth of the bone hole where the tendon is pushed inward (in an effort to restore anatomical tension to the tendon). With the tendon pierced and engaged by the sheath 610, the sheath 610 can be advanced into the bone hole H thereby "submerging" the tendon into the bone hole. As shown in Figure 10B, when the sheath 610 is fully inserted into the bone hole H, the anti-sink flange 613 will be in a boundary position against the top surface of the bone and tendon, thus compressing the tendon T against the bone. The expansion screw 620 can then be advanced into the sheath, for example by threading the expansion screw 620 into the sheath 610, to cause radial expansion and anchoring of the sheath 610 within the bone hole. As shown in Figure 10B, the pins 619 will remain penetrated into the tendon, thereby further preventing tendon slippage. In this embodiment, the pins 619 are shortened so that they do not extend completely through the tendon. Figure 11 illustrates the sheath 310 of Figure 7 showing the longer barbed pin 319 penetrating completely through the tendon.
    [00077] Figures 10C to 10E illustrate another method of anchoring a tendon within a bone hole. When a tendon is positioned at a desired tension through a bone hole and a sheath is used to engage and advance the tendon into the bone hole, the sheath pulls the tendon into the bone hole, undesirably changing the tension. In order to allow tendon tension to be maintained, the sheath would need to engage the tendon at a distance from the bone hole. When the T tendon is pierced at a closer location so as to account for a known depth of the H bone hole into which the T tendon is pushed in, no additional force is created on the tendon. In the embodiment, the distance may be equal to the depth of the bone hole. By having the amount of tendon pulled into the bone hole equal to the depth of the bone hole, the tension in the tendon can remain unchanged.
    [00078] Figures 10C to 10E illustrate a method for using the sheath to measure a distance from the bone hole, thereby allowing a user to engage the tendon at a distance from the bone hole that is substantially equal to the depth of the bone hole. While the method may be performed using any of the various sheaths and expanders disclosed herein, Figures 10C to 10E are described in connection with sheath 610' and expansion screw 620' having a similar configuration to the sheath of Figures 7 to 9 and the expansion screw of Figure 1. In this embodiment, the sheath 610' includes a pair of pins 619', positioned parallel to and extending distally from the distal surface of the sheath. The pins 619' in the sheath may be a known or fixed distance apart. As a non-limiting example only, pins 619' may be spaced 5 mm apart. Figure 10C illustrates a tendon T extending through a bone hole H and maintained at a desired tension. With the tendon held at the desired tension, pins 619' can be used to measure a distance along the tendon from bone hole H. The distance is preferably equal to the length of the sheath, however the distance can be modified to increase or decrease the tension applied to the tendon. By way of non-limiting example, for a sheath having a length of 25 mm, pins can be used to measure, in 5 mm increments, a distance which is 25 mm from the bone hole. This can be achieved by positioning or repositioning the pins in 5 mm increments from the bone hole, or by positioning the pins in the tendon and rotating or "driving" the pins to move the sheath in 5 mm increments away from the bone hole. When the sheath is positioned at a desired distance, for example 25 mm from the bone hole, the pins can be engaged within the tendon. As shown in Figure 10D, stakes 619' are rotated before engaging the tendon to align the stakes with the axis of tendon T. When stakes 619' are engaged with tendon T, tendon T can be positioned over the bone hole for insertion, as shown in Figure 10E. The sheath and tendon can be fully inserted into the bone orifice H. In this embodiment, and again referring to Figure 10B, the pins 619' will remain engaged in the tendon, thus further preventing the tendon from slipping.
    [00079] While Figures 7 to 11 illustrate pointed pins that are configured to penetrate partially or entirely through the tendon, in other embodiments the pin(s) may have a rounded tip configuration so as to skewer the tendon without puncturing the tendon. Figure 12 illustrates one embodiment of a sheath 710 having pins 719 that have a rounded tip. In this embodiment, the sheath 710 includes two pins 719 that are spaced apart a distance that is less than the width of the tendon, so as to allow the pins to impinge on the tendon, rather than separating the tendon.
    [00080] In other embodiments, the tendon coupling element may be movable so as to hold the tendon. Figures 13A to 13B illustrate a sheath 810 having a fork-shaped tendon engaging member with bendable spikes 819 extending distally from the most distal surface of sheath 810. Each spike is generally of an elongated triangular configuration with a distal tip. pointed 819d to skewer or penetrate a tendon. Depending on the size of the tendon, the tips could alternatively be configured to separate the tendon. A proximal end 819p of each tip may be hingedly coupled to the sheath, for example using a hinge joint or by a thinner connection point which allows the material to flex at the joint. In use, the tips 819 of the sheath 810 may be penetrated into a tendon T, as shown in Figure 13A, and then the sheath 810 and the tendon T may be advanced into the bone hole B. The sheath 810 may have a length which causes the prongs 819 to contact an opposing surface of the bone, thereby causing the prongs to bend inward toward each other and toward the central vertical axis of the sheath, as shown in Figure 13B. The tips 819 will thus engage the T tendon, thus preventing the tendon from slipping. Such a configuration is particularly advantageous with the shallow bone hole, where the pins have the ability to collapse if they "bottom out" into a shallow hole, allowing the pins to squeeze the tendon and further secure it in place. An expansion screw can then be inserted into the sheath to anchor the sheath and tendon within the bone hole as previously described.
    [00081] In another embodiment, the tendon attachment element may be in the form of a hook, open loop or closed loop. Figure 14A illustrates an embodiment of sheath 910 that is somewhat similar to the sheath of Figures 1 to 6 in that it includes radial ribs 916, longitudinal ribs 918, exhaust channels 914, an anti-sink flange 913a, and a cortical attachment flange. 913b. In this embodiment, however, the tendon engagement element is in the form of a J-shaped hook 919 extending from the distal face surface. The hook may be formed of an elongated, flat, generally rectangular member that is curved at its distal end to create the J-shape. The proximal end 919p of the hook 919 is attached to one side of the sheath 910, with the hook extending through the central longitudinal axis. The hook attachment location is preferably oriented so that the hook is aligned with the escape channels 914 in the sheath. Such a configuration will allow the tendon, when seated within the hook, to extend along opposite sides of the sheath with escape channels 914 located between the tendon legs. In an exemplary embodiment, the hook may be oriented as shown in Figure 14B, which illustrates the hook 919 before and after insertion into the bone hole. Exhaust channels 914 can be formed in one location so that they are positioned in line with the hook. As a result, the sheath will separate in the middle, with one side wall of the sheath moving toward one leg of the tendon and the other side wall of the sheath moving toward the other leg of the tendon.
    [00082] In another embodiment, as shown in Figures 15A to 15B, the tendon engaging element in the sheath 150 may be in the form of a fully enclosed arc or ring or ring 159. Ring 159 may have an outside diameter that corresponds to an outside diameter of the sheath 150 such that the ring 159 extends from either side of the sheath. This configuration will allow the tendon to be threaded through the ring 159 before inserting the sheath into the bone hole. In use, the central axis of the ring 159 is preferably oriented in line with the tendon so as to allow the tendon to extend in a linear configuration around the sheath 150. A person skilled in the art will understand that while a circular ring shown, the arc or ring can be of various shapes, such as oblong or elliptical, square, etc.
    [00083] In another embodiment, shown in Figure 16, the sheath 160 may include a separate ring or semicircular ring that has a cutout or opening 169a on one side thereof so as to allow the tendon to pass within the ring through the side, rather than threading through it. In other embodiments, the length of the ring can be varied so that the ring has an oblong configuration. Figure 17 illustrates sheath 170 having an oblong ring 179 with an opening 179a in one side thereof, similar to a carabiner. Figure 18 illustrates the sheath 170 of Figure 17 implanted in bone. As shown, the oblong shape of the ring 179 allows the entire tendon to be received there. In the embodiment of Figure 18, the sheath body has a relatively short configuration, with a length that is less than the length of the ring 179. Such a configuration allows a greater volume of tendon to be captured in the ring 179.
    [00084] While each of the aforementioned embodiments includes sheaths having tendon engaging elements that impinge, penetrate, or otherwise secure or engage a tendon, in other embodiments the tendon engaging elements may be configured to separate a tendon. , for example receive a tendon between each other. Figures 19A through 19B illustrate such an embodiment of the sheath 190A having a pair of rounded forked prongs 199a that extend substantially parallel to one another from opposite side walls of the sheath. Since the spikes extend from the outermost side walls of the sheath 190A, the spikes 199a are configured to receive a tendon therebetween, rather than penetrating a tendon. The length of the forked ends can vary as well. Figure 19A depicts short spikes 199A, while Figure 19B illustrates an embodiment of sheath 190B having long spikes 199b, with a larger tendon seating recess formed therebetween. Longer tips can also be particularly suitable for measuring the size of a tendon.
    [00085] Figure 20A illustrates another embodiment of the sheath. As shown in Figure 20A, the sheath 200A has an elongated generally cylindrical configuration with an inner lumen 202a extending from an open proximal end and terminating near a closed distal end. The proximal end may include a funnel-shaped shoulder 204a on opposite sides thereof to create an elongated opening. The shoulders of the funnel 204a can thus serve as an entry area for the expansion screw. The width W of each funnel shoulder can vary and the extensions can extend completely or partially around the entire half of the hem circumference. The height H of each shoulder 204a may also vary, but preferably each shoulder 204a extends only along a proximal portion of the sheath 200A. When the funnel shape is expanded, it can press the tendon against the bone. As further shown in Figure 20A, the sheath may also include a concave outer sidewall 208a on opposite sides thereof (only one sidewall is shown) in a location aligned and extending distally from the shoulders 204a. The remaining side walls connecting the opposing concave side walls 208a may have a convex configuration. The tendon may be configured to extend along concave side walls 208a and along shoulders 204a. The convex side walls may include indentations or slots 206a, as shown, to allow the sheath 200A to expand when an expander is inserted therein. Elongated slots 206a may extend from the proximal end and may terminate near the distal end. As shown in Figure 20A the slits 206a terminate in a middle portion of the sheath 200A. Alternatively, as shown in Figure 20B, the sheath 200B may include grooves (not shown) formed in an inner and/or outer surface thereof that are configured to break during expansion of the sheath. Figure 20B is otherwise identical to Figure 20A and thus similar reference numbers are used to refer to similar parts.
    [00086] Continuing to refer to Figure 20A, the distal end of the sheath may include opposing extension flaps 209a extending from the concave sides thereof, i.e., the sides having slots 206a formed thereon. The extension tabs 209a may each have a generally rounded distal end and they may define a recess 207a therebetween for seating the tendon. The length of the flaps and the depth of the recess can be varied as desired, depending on the size of the tendon to be received between them.
    [00087] Figure 21 illustrates another embodiment of the sheath 200C which is similar to the sheath 200A of Figure 20A, but in that embodiment, instead of having a funnel shoulder the sheath includes a proximal flap or flange 204c extending radially outward from the sheath. one side of it. In particular, flange 204c has a generally semi-circular configuration and is coupled to and extends outward from a more proximal end of concave side walls 208c. In use, the flange 204c will be in a boundary position against an external surface of the bone, thus limiting the depth of insertion of the sheath 200C into the bone. Flange 204c will also compress the tendon against the surface of the bone, helping to anchor the tendon. Figure 22A illustrates yet another embodiment of sheath 220 having a flange 224 and an opposite tapered shoulder 225, with a shoulder 225 positioned distally from the flange 224 so that the flange 224 extends radially away from the proximal surface of the tapered shoulder 225. A. Figure 22B illustrates a top view of the sheath 220 showing the flange 224 extending radially outward from the tapered shoulder 225 and showing the distally located concave side wall 228. The opposite side of the sheath 220 similarly includes a tapered shoulder 225 and a concave side wall. 228. In use, the flange 224 will compress the tendon against the surface of the bone and the shoulders 225 will compress both legs of the tendon against the side walls of the bone hole.
    [00088] Figures 23A to 23B illustrate another embodiment of the sheath 230 which is similar to the sheath 200C of Figure 21 but which includes side wall slots 236 to allow the sheath to expand. In particular, the sheath 230 includes opposing concave sidewalls 238 which curve radially inwardly and opposite convex sidewalls 209 extending between the concave sidewalls 238 and having elongated slots 236 formed therein. The concave side walls 238 are each configured to seat a leg of the tendon, with the tendon extending through the tendon seating recess 237 formed between the distal prongs 232. In that embodiment, the sheath 230 additionally includes a cylinder. 231 extending longitudinally along each corner connecting side walls 238, 239. In other words, sheath 230 has four cylinders, one at each corner. Each cylinder may be formed by a portion of each sidewall being bent to create a hollow channel therebetween. Such a configuration may allow the cylinder to expand and the side walls to move away from each other when an expander is inserted into the sheath. The cylinder thus functions similarly to a hinge, allowing the side walls to move away from each other without breaking. The sheath may further include a proximal flange 234 extending radially outward from one of the concave side walls 238. The flange may overlap the tendon entering from the side that is attached to the muscle, identified as south (S) in the figure. The proximal flange 288 rests on the surface of the bone and presses the tendon down and can also serve as an anti-sinking element. As shown in the top view of sheath 230 in Figure 23B, east (L) and west (O) side walls 239 may be outwardly curved and may include elongated slots 236. Side walls 238 facing north (N) and south ( S) can be contoured to curve inward. When the tendon is coupled to the sheath 230 it may extend under the proximal flange 234 and extend along the south facing sidewall 238 around the distal end between the bifurcated tips 232 and upward along the sidewall 238 facing north.
    [00089] Figures 24A to 24D illustrate a method for anchoring the tendon to a bone using a sheath having a bifurcated tip that is configured to separate the tendon. A person skilled in the art will understand that the method can be used in connection with any of the sheaths shown in Figures 19A to 23B. By way of non-limiting example, a sheath 240 is shown having forked spikes 241 at the distal end thereof. Sheath 240 is also shown having a threaded hole formed therein and threadably fitted to a threaded end on a guidewire 250. An exemplary method for utilizing the biceps tenodesis anchor and providing tools for performing biceps tenodesis surgery may include tendon preparation and tendon measurement. For example, as shown in Figure 24A, the sheath 240 can be manipulated to position the tendon between the bifurcated tips 241. Different sized sheaths having forked tips with different spacings can be used to assess the size of the tendon. When the appropriate size sheath 240 is selected, the bifurcated tips 241 can be positioned around the tendon T, and the sheath 240 can be inserted into the bone hole B by pushing the tendon into the bone hole, as shown in Figure 24B . The T tendon will extend along opposite sides of the sheath. Although not shown, an inserted tool can be attached to the guidewire and can be used to facilitate insertion of the sheath and tendon into a bone hole. The insertion tool can be disengaged from the guidewire 250 so that the guidewire 250 remains coupled to the sheath 240 after insertion into the bone hole B. As shown in Figure 24C, an expander 260 can be advanced over the bone. guidewire 250 and inserted into sheath 700. Although not shown, a steering tool may be attached to expander 260 and used to advance the expander along the guidewire and to direct the expander into the sheath. The steering tool can be removed and then the guide wire can be disengaged from the anchor assembly (not shown). As shown in Figure 24D, the anchor assembly including sheath 240 and expander 260 remains within the bone hole B with the tendon T extending around it and positioned between the bifurcated tips 241 at the distal tip of the sheath 700.
    [00090] A person skilled in the art will understand that in any of the embodiments presented in the present invention, the pins may be malleable to allow a surgeon to flex and manipulate the pins into a desired configuration to facilitate insertion of a tendon into a bone.
    [00091] Figures 25A through 25E illustrate yet another embodiment of an anchor assembly 300 for anchoring a tendon to a bone. In that embodiment, the sheath 310 is separated at the distal end 310d so that it is generally cylindrical at the proximal end 310p and along a proximal portion thereof and two legs 312a and 312b extend distally therefrom. Legs 312a and 312b may be separated by opposing slits (only one slit 313 is shown) formed in the sheath and extending from distal end 310d and terminating distally to proximal end 310p. In the illustrated embodiment, the slits are narrower along the proximal portion and wider along the distal portion. The wider distal portion of the slits can seat and engage a tendon therebetween, as shown in Figure 25C. The tendon can extend in the t direction shown in Figure 25D. Legs 312a and 312b may be flexible and may expand radially outward to anchor sheath 310 within the bone hole. As shown in Figures 25D and 25E, the side walls may include an exhaust cut F formed therein to create a flex point to allow the legs to pivot out into an exhaust cut F as the expander (320) advances through the increased wall thickness (bulge, internal mass, rib, etc.) - point P. Exhaust cut F can be formed at a location distal to the proximal end 310p, such that pivot point P is within or below the cortical bone . The escape cut F may be in the form of a slit extending partially or completely through the side wall of the anchor and preferably extending at least partially radially around the side wall to allow pivoting movement of the legs 312a and 312b . The legs 312a and 312b may be of such length that when the sheath 310 is implanted in the bone, the legs 312a and 312b extend below the surface of the cortical bone and expand radially outward beyond the size of the bone hole to thereby retain the sheath inside the bone hole. As further shown in Figures 25A through 25E , the sheath 310 may optionally include a head or flange 314 formed at the proximal end that abuts the surface of the bone to limit an insertion depth of the sheath into the bone. Flange 324 may include exhaust cutouts 315a and 315b formed on opposite sides thereof to seat the tendon, as shown in Figure 25B. Anchor assembly 300 may additionally include an expander 320 that is configured to be received between an internal lumen extending through the sheath. Expander 320 can be a threaded screw that threadably fits with threads formed on an inner surface of sheath 310, or in other embodiments expander 320 can be unthreaded or partially threaded. Inserting the expander into the sheath can cause the legs to expand radially outward. One skilled in the art will understand that a variety of other techniques can be used to cause the distal end of the sheath to expand.
    [00092] One skilled in the art will understand that the biceps tenodesis methods and devices described in the present invention can be used in a variety of surgical procedures for trauma or injury to a tendon being attached to bone through a bone hole. The present invention also has application in conventional joint repair surgery.
    [00093] Those skilled in the art will understand other features and advantages of the invention based on the embodiments described above. Accordingly, the invention is not to be limited by what has been particularly shown and described, except as indicated by the appended claims. All publications and references cited are expressly incorporated herein by reference in their entirety.
    权利要求:
    Claims (9)
    [0001]
    1. Anchor assembly for anchoring a tendon (T) to bone (B), comprising: a cylindrical sheath (10, 110, 210, 510, 610, 810) with bone engaging surface elements (16, 18, 113b, 216, 218) formed on its outer surface, and with an inner lumen (12) formed therein and extending from an open proximal end (10p) to a closed distal end (10d), the closed distal end ( 10d) including at least one tendon anchoring member (19, 119, 219, 519, 619, 819) extending distally therefrom and configured to facilitate anchoring of a tendon to bone; and an expander (20) having an elongated cylindrical configuration and sized and shaped to be received in the inner lumen (12) of the sheath (10, 110, 210, 510, 610, 810), the expander (20) having a lumen (23) ) which extends through it to receive a guidewire. wherein at least one tendon anchoring member comprises first and second pins (19, 119, 219, 519, 619, 819) spaced apart and extending distally from a surface facing the distal face of the sheath (10). , 110, 210, 510, 610, 810); characterized in that at least one pin (19, 119, 219, 519, 619, 819) has a distal pointed tip (819d) configured to penetrate through tissue (T).
    [0002]
    2. Anchor assembly according to claim 1, characterized in that the first and second pins (19, 119, 219, 519, 619, 819) extend parallel to each other.
    [0003]
    3. An anchor assembly according to claim 1, characterized in that at least one tendon anchoring element comprises first, second and third pins (519) that extend distally from a face-facing surface distal of the sheath (510).
    [0004]
    An anchor assembly according to any preceding claim, wherein the proximal open end of the sheath (110, 510, 610) includes opposing flanges (113a, 513, 613) extending radially outward therefrom. and configured to limit an insertion depth of the sheath (110, 510, 610) into a bone hole.
    [0005]
    An anchor assembly according to any one of the preceding claims, characterized in that the sheath (210) includes opposing first and second slots (214) extending proximally from the distal end, the opposing slots (214) being configured to allow the sheath (210) to expand radially outwardly when the expander (20, 120) is received therein.
    [0006]
    6. An anchor assembly according to any one of the preceding claims, characterized in that the sheath (10, 210) includes at least one rib (18, 218) formed on the external surface thereof and extends longitudinally in a proximal-distal direction.
    [0007]
    An anchor assembly according to any one of the preceding claims, characterized in that the expander (120) includes a flange (121) extending radially outward from a proximal end (120p) thereof.
    [0008]
    8. An anchor assembly according to claim 1, characterized in that it comprises: a sheath (110, 210) with a body having at least two side walls (111a, 111b, 111c) extending proximally therefrom, the side walls (111a, 111b, 111c) defining an inner lumen therebetween and the side walls (111a, 111b, 111c) having threads formed on an inner surface thereof; and an expander (20, 120) is threaded and configured to be received between the side walls (111a, 111b, 111c) and to threadably engage with the threads formed on the inner surface of the side walls (111a, 111b, 111c); the sheath (110, 210) and the threaded expander (20, 120) are configured so that when the expander (20, 120) is fully threaded into the sheath (110, 210), the sheath (110, 210) expands radially outward to retain a tendon (T) within a hole in the bone.
    [0009]
    9. An anchor assembly according to claim 1, characterized in that the pins (819) comprise folding pins (819) configured to move radially inwardly towards each other to engage a tendon (T) between they.
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    CN105559946B|2021-02-09|
    US20200008928A1|2020-01-09|
    US10751161B2|2020-08-25|
    CN105559946A|2016-05-11|
    EP3020369A1|2016-05-18|
    CA2909944A1|2016-04-23|
    JP2016083365A|2016-05-19|
    JP6800572B2|2020-12-16|
    US20160113758A1|2016-04-28|
    AU2015243092B2|2020-05-14|
    BR102015026658A2|2016-04-26|
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    法律状态:
    2016-04-26| B03A| Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]|
    2018-10-30| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|
    2020-03-10| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-11-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    2022-01-11| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/10/2015, OBSERVADAS AS CONDICOES LEGAIS. |
    优先权:
    申请号 | 申请日 | 专利标题
    US201462067701P| true| 2014-10-23|2014-10-23|
    US62/067,701|2014-10-23|
    US14/610,626|2015-01-30|
    US14/610,626|US10751161B2|2014-10-23|2015-01-30|Biceps tenodesis anchor implants|
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