Improved strength and fatigue life of active bone and joint stabilization devices

Abstract

Bone and joint stabilization devices or systems including a multi-layer body are described. The described approach significantly improves fatigue life compared to otherwise similar or equivalent one-piece spring components. Coordinated increased strength anchor embodiments, anchor loading tools, and methods of use are also described.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims protection to U.S. Provisional Application No. 63 / 001,107 filed on March 27, 2020, U.S. Provisional Application No. 62 / 914,172 filed on October 11, 2019, U.S. Provisional Application No. 62 / 896,302 filed on September 5, 2019, and U.S. Provisional Application No. 62 / 837,579 filed on April 23, 2019, all of which are incorporated herein by reference in their entirety for all purposes. Technical Field

[0003] The embodiments described herein relate to the field of surgery, and more particularly, to bone fusion, joint stabilization, and / or fracture fixation surgery. Background Art

[0004] U.S. Patent Nos. 10,194,946 and 10,555,766 describe embodiments of bone and / or joint stabilization devices that can be tensioned during a medical procedure to remain active while maintaining compression of associated anatomical structures during use. In many of these embodiments, an orthopedic surgical device or system includes an elongated member or body that includes a spring pattern having a plurality of beams, each beam including a transverse member that is free to deflect when the elongated body is axially stretched. The overall flexibility of this architecture also allows for torsional, orthogonal, external and internal rotation, etc., movement of the implant and associated anatomical structures, thereby achieving a full anatomical range of motion.

[0005] The anchor head can receive the elongated body and can secure it with one or more teeth included in a one-way (e.g., ratchet) interface. Two such anchors can be used, or one such anchor can be used with deployable foot anchors at opposite ends of the elongated body. The "teeth" of the anchor head referred to can be partially received into the thickness of the spring member body, or it can pass through the entire thickness of the spring member. In this case, the teeth can abut the opposite wall of the feed port in the anchor head, or further depend to be supported by the opposite ledge.

[0006] The implantable devices covered by the above patents have been used effectively in the treatment of human patients. In these surgical procedures, they provide a new and uniquely useful tool for the treatment of traumatic orthopedic injuries. However, improvements in design are still desired to increase the ultimate strength of certain components and extend the cyclic fatigue life. Summary of the invention

[0007] The present invention embodiments or variations are related to those described above, but modified in various ways to achieve significantly extended cyclic fatigue life and / or ultimate strength of certain components. Useful spring member architectures and details of anchor head, screw, and foot features are described in U.S. Patents Nos. 10,194,946 and 10,555,766 and WO2016 / 122944; US2019 / 0046253; WO2019 / 032231; USSN 62 / 788,343; USSN 62 / 788,377; USSN 62 / 788,388; and USSN 16 / 728,851, all of which are incorporated herein by reference in their entirety for all purposes (particularly as variously cited below).

[0008] More specifically, embodiments thereof include Nitinol (generally, a NiTi alloy that is superelastic (SE) at human body temperature, i.e., has an A of less than about 37°C. f ) spring member having multiple finite thickness layers as described below. This approach significantly improves fatigue life compared to a one-piece spring member of similar or comparable overall thickness. The multi-layer spring member of the present invention may be used in a system having an anchor head or foot as described herein, such as those cited above from the '964 patent (particularly those in which the teeth extend through the entire thickness of the spring member body), or another approach. Nonetheless, the coordinated anchor head embodiments and methods of use described herein (particularly with respect to system tensioning) optionally present certain advantages.

[0009] Devices, systems (assembled or unassembled) including devices (or device components or subcomponents), methods of use (e.g., implantation, during treatment of a patient when the system is repaired and / or removed), and methods of manufacture (including assembly of various components - if applicable - by technicians prior to sale or by a surgeon during a medical procedure) are all included within the scope of the present invention. Such systems may include loading devices or tools as described herein. The methods of the present invention, including methods of use and / or manufacture, may be performed in any logically possible order of events and in any listed order of events. Medical methods may include any activities of surgical staff associated with device provision, implant introduction, positioning and / or repositioning, and surgical approach, closure and / or removal (e.g., as in explantation surgery). BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The details of the subject matter set forth herein, both as to its structure and operation, may be apparent by studying the accompanying drawings, in which like reference numerals may refer to like parts. The components in the drawings are not necessarily drawn to scale, with emphasis instead being placed on illustrating the principles of the subject matter. The illustrations are intended to convey concepts, in which relative size, shape, and other detailed attributes may be shown schematically or precisely. Features drawn to scale (e.g., from engineering drawings and / or photographs) may serve as antecedent basis for claim support.

[0011] Figure 1A is a partial perspective view of an example embodiment of a single spring member layer; Figure 1B Is caused by Figure 1A A partial perspective view of an example embodiment of a construction made of multiple layers is shown.

[0012] Figure 2A-2C Is such as Figure 1A and Figure 1B A side perspective view of an example embodiment of a complete orthopaedic implant or surgical system showing a spring member layer.

[0013] Figure 3A It is available for Figure 2A-2C A perspective view of an example embodiment of an anchor head (or attachment button) in the system and other related embodiments; Figure 3B yes Figure 3A A cross-sectional view of the main body portion of the anchor head is shown.

[0014] Figure 4A yes Figure 3A A perspective view of an anchor head with a multi-layer spring member received therein in preparation for anchoring or deployment of the anchor teeth; Figure 4B yes Figure 4A A cross-sectional view of the components in which the teeth are in their fixed or final position to secure the spring member.

[0015] Figure 5A It is available for Figure 2A-2C A perspective view of another example embodiment of an anchor head in a system of FIG. Figure 5B yes Figure 5A A cross-sectional view of the main body portion of the anchor head is shown.

[0016] Fig. 6A is a perspective view of an upper or outer body portion of another example embodiment of an anchor head; Figure 6B It is a three-dimensional view of its lower or internal main part.

[0017] Fig. 7A and Figure 7B is with Figure 3A-3B and Figure 5A-Figure 5B Different perspective views of an example embodiment of an anchor loader for use with the anchor head detailed in FIG.

[0018] Figure 8 is a perspective view of another example embodiment of an anchor loader with an anchor housed therein.

[0019] Fig. 9A and Fig. 9B yes Figure 8 A side cross-sectional view of the anchor loader shown in FIG.

[0020] Fig.10 yes Figure 8 A bottom cross-sectional view of the anchor and anchor loader shown in FIG. 1 with a spring member added.

[0021] Fig.11A is a perspective view of an embodiment of an anchor loader including an active braking feature and a locking collar. Fig. 11B yes Fig.11A A bottom cutaway view of an anchor loader with the anchor head and spring member sections added. Fig. 11C is configured for machining or injection molding in two parts Fig.11A An assembly or construction diagram of a portion of an anchor loader embodiment.

[0022] Fig. 12A is a perspective view of an embodiment of an anchor loader including a braking gear. Fig. 12B yes Fig. 12A A bottom cutaway view of an anchor loader with the anchor head and spring member sections added.

[0023] Fig.13 An example embodiment of an overall system is depicted, wherein components are selected from those variously shown in the above-referenced figures.

[0024] Fig.14 is, for example, a flow chart of an embodiment of a tensioning method.

[0025] Figure 15A-Figure 15C Different patterns are shown that may be used for embodiments of the spring members thereof. DETAILED DESCRIPTION

[0026] Various example embodiments are shown in the drawings and are further described below. These examples are cited in a non-limiting manner, as it should be noted that they are provided to illustrate the more widely applicable aspects of the device, system and / or method. Various changes may be made to these embodiments and equivalents may be substituted without departing from the true spirit and scope of the various embodiments. In addition, many modifications may be made to adapt specific circumstances, materials, compositions of matter, processes, process behaviors or steps to the purpose, spirit or scope of the subject matter of the present invention. All such modifications are intended to be within the scope of the claims that may be proposed herein.

[0027] Example Embodiments of Spring Members

[0028] Figure 1A An example embodiment of a single layer 10 (also referred to as a body, or a component body or portion) is shown, which can be stacked to produce or define a Figure 1B Spring member configuration 100 is shown. As already mentioned (and described in greater detail herein), implant embodiments utilizing spring member configuration 100 have significantly and unexpectedly improved fatigue life compared to one-layer spring members that are otherwise similar or comparable in overall thickness.

[0029] like Figure 1A and Figure 1B As shown, the layer 10 is in the form of a stretchable or spring-type framework, which includes a plurality of beams or beam members 12. The beams 12 each include a transverse rod or beam member 14 that can be freely deflected to axially stretch the spring member layer 10. The transverse rods 14 are arranged in opposite pairs, and are joined to each other at the external extension connectors 16 of each beam. In other words, the layer 10 can include a plurality of beams 12 arranged in pairs, wherein the first beam and the second beam in each pair are connected to each other only at two lateral external extensions 16, so that the first beam is opposite to the second beam. Each connector 16 can be a curved continuation of each rod 14 or beam 12 or otherwise configured. Each pair of beams 12 is connected to an axially adjacent pair by an intermediate connector or bridge 18. Therefore, as shown, there is a gap at the two lateral external extensions between each pair of beams and the adjacent pair of beams. The beams 12 or beam pairs serve as leaf spring elements in series, which are arranged in a unit 20, each unit having a central window or aperture 22.

[0030] The shape of these (integrated or integrated) elements may be in a race-track configuration as shown. In the same basic description above, the various beams, rods, and connectors may be configured to be substantially rectangular, elliptical, circular, or other configurations (e.g., including more complex aspects such as those of USPN 10,194,946 cited above). Figure 4B The stress relief features shown below are combined with Fig. 9B or otherwise described).

[0031] anyway, Figure 1BAn integral spring member or multi-layer spring member construction 100 is shown in FIG. It may include a weld or weld bead (WB) at either end (only one end is shown, but both ends may be welded). The weld bead or weld may be placed as shown to capture all layers or elsewhere with the same result. In any case, welding is used to hold its individual or other independent layers 10 together for ease of handling before applying the anchor and after any trimming after setting the final position of the anchor. Alternatively, a preloaded anchor or button (of the same type as described or another configuration, such as a welded all-metal button) at one end may secure the piece or element together. Further, the layers may be adhered, brazed or pinned together, swaged in a ferrule or hypotube, or secured in a length of heat shrink tubing.

[0032] Whether provided by a weld, multiple welds, or other means, the connections between the layers are typically located in areas that can be trimmed off the implant and discarded after sizing. The layers of the final (i.e., trimmed configuration) spring member portion of the implant are typically secured or coupled only at their respective ends (via an anchoring head or attached foot and anchoring head). Thus, the individual layers can operate in a parallel spring arrangement, but failure of one layer (e.g., due to cyclic fatigue) will not affect the performance dynamics of the other layers.

[0033] That is, an implantable sheath may be used in the system of the present invention (e.g., the system described in U.S. Pat. No. 10,194,946). This sheath may surround and hold the spring member layers together within a given contour or envelope, but generally does not lock them together or couple them along their length.

[0034] When additional axial force functionality and / or a higher spring rate is desired, layers of a given thickness (typically—although not necessarily—having the same thickness as shown) may be stacked to define a thicker implant. Three such optional additional layers 102, 104, and 106 are provided in Figure 1B In contrast, fewer layers may be stacked in thinner implants to indicate where it is desired to reduce the compressive forces. In general, to provide redundancy in the event of a single layer failure according to the above logic, at least two or more layers are used, and preferably at least three or more layers.

[0035] like Figure 1A As shown, the thickness of each layer of the beam member 12 (T b ) and width (W b ) can be about 1: 1. This ratio can be relatively smaller or larger, for example, from about 2:3 to about 3:2 and still achieve fatigue advantages.

[0036] In terms of absolute dimensions relative to, for example, the NiTi material example described herein, the beam thickness may be approximately 0.01 inches (0.25 mm). More specifically, its thickness may be between 0.008 inches (0.20 mm) and 0.012 inches (0.30 mm). Further variability is also possible. For example, a three-layer spring member body may be demonstrated to be fatigue resistant (as well as provide some redundancy in the event of failure of one layer) with layer thicknesses between approximately 0.013 inches (0.33) and approximately 0.015 inches (0.4 mm). Similar dimensions for other materials may also be derived by one skilled in the art, with the benefit of this description.

[0037] Example System or Device Embodiments

[0038] Figure 2A A first overall device or system or embodiment 200 is shown. In this embodiment, two opposing anchors or anchor heads 30 are used to associate with the spring member 100. Alternatively, the anchor heads may be referred to as buttons or button anchors. The spring member 100 in this embodiment 200 may include additional tabs 24, each of which defines an eyelet 26. Similar tab features are disclosed in U.S. Publication No. 2019 / 0046253 and PCT Publication No. WO 2019 / 032231 for tying or otherwise securing an associated introducer (or "Beath") needle with a length of suture or other cord. Thus, only one such tab / eyelet feature need be used in the device 200, but both may be included for ease of manufacturing and / or welding purposes. Figure 2A Also shown is the manner in which multiple individual spot weld beads (WB) may be used to secure layers (six such layers in the case of this embodiment 200) to one another.

[0039] In use, the needle passes through a clearance hole drilled in the bone and is used to pull the spring member therethrough. Given the triangular shape of the associated tabs and eyelets, the front end of the device is self-centering relative to the bone tunnel through which it passes. Finally, when the anchor head is secured after any desired tensioning, the tab(s) 24 are trimmed along with any associated excess length of the resilient member 100. As in the patents and patent applications cited above, this trimming can be accomplished with a flat-tipped cutter, custom tool, or otherwise.

[0040] Figure 2BA second device or system embodiment 210 is shown. It includes an anchor head 30, optionally as described above, and pivoting foot anchors 60 at the ends of the spring member. Specifically, embodiment 210 includes straight axial or longitudinal extensions 112 extending from each layer 10 in the spring member portion 110. The extension of each layer includes a terminal eyelet 114. A single cross pin 28 is received in an opposing boss 62 of the foot anchor through the eyelet. A press fit may be used to secure the pin in the boss. This approach is both simple and provides a given orientation of the anchor foot relative to the width of the spring member body.

[0041] Figure 2C A third device or system embodiment 220 is shown. Similar to Figure 2B In the embodiment of FIG. 2 , one anchor head 30 and one rotatable anchor foot 60 are used. However, in device 220 , the body 120 is rotated 90 degrees relative to the orientation of the anchor foot.

[0042] This orientation may be desirable for treating certain indications.In addition, because the face 64 of its anchoring foot 60 lies flat against its spring member body 120, the system 220 can be configured to pass through a slightly smaller guide hole in the bone than the system 210 having an orthogonal body / foot orientation.

[0043] It is also worth noting that the pattern of cells 20 in spring member 120 can extend almost to the pivot pin 28 of the anchor foot. This can be advantageous in maximizing the effective length of the device (e.g., in the example provided, system 220 includes 5 more spring member cells 20 than system 210). For a given amount of axial displacement required of the device, a longer effective length (or in other words, a greater number of otherwise identical cells within a given length) will reduce the strain in each cell, thereby providing the potential for further improvement in fatigue life.

[0044] For construction, the material layer 10 defining the spring member layer in the system 220 is bent in a folded form and heat set (e.g., in an oven at about 500 degrees Celsius for about 5 minutes or in a salt bath for less time) to define a stirrup at the fold 122 to accommodate the pivot pin for foot attachment. The stirrup can be a simple "U" shape. However, a "C" or "light bulb" shape is desirable for capturing the pin 28.

[0045] In embodiment 220, two parts or components (1, 2) are folded to form four layers 10 in spring member portion 120. Alternatively, one folded piece may be used to provide two layers of spring members, or three folded pieces may be used to provide six layers of spring members, etc.

[0046] Figure 2B and Figure 2CThe embodiment of each pinned to the foot is advantageous in that it is securely connected and easy to manufacture with precision. So connected or fixed, the anchor foot 60 can be rotated from a position aligned with the spring member body 110 / 120 to a position lateral (or at least angled, typically upwardly about 45 degrees or about 60 degrees up to 90 degrees) to the spring member body to anchor the entire device (usually the distal end) during medical procedures.

[0047] Complex features may also be provided (e.g., a device that provides a bias toward a lateral position to assist in transitioning from an axial delivery configuration of the foot to its implanted position via an integral or supplemental coil spring). Alternatively, one or more pull wires or cords may be employed to accomplish or assist such rotation. Other deployment system options suitable for use herein are set forth in U.S. patent application Ser. No. 16 / 728,851, filed Dec. 27, 2019, entitled “Bone and Joint Stabilization Device Features and Delivery Systems.”

[0048] In contrast, the multilayer spring member components described herein can be used in the systems shown and described in the 16 / 728,851 application. Examples of such systems include devices with bone screws and various pin configurations. Independent of these details, the construction techniques described in that application and other patents and patent applications incorporated herein by reference (e.g., laser cutting of specific planar patterns (such as, Figure 12A-12B ) or injection molded similar parts) and material selections (e.g., Nitinol or beta titanium alloy for the main body layer of the spring member, polyether-ether-ketone (PEEK) or polyetherimide (PEI) polymer materials for the anchor head and / or foot, stainless steel for the cross pin, etc.) may also be used in embodiments of the present invention.

[0049] Anchor Head or Button Embodiment

[0050] exist Figure 3A-Figure 4B In the illustrated embodiment of the anchor head 30, the body or base 31 of the anchor head may be made of PEEK or another biocompatible polymer. It may be machined, molded, or 3D printed by fused filament fabrication (FFF) or selective laser sintering (SLS), or other means. The polymer may be loaded with a radiopaque material, such as barium sulfate for radiopacity.

[0051] Alternatively, the body or base 31 may be made of titanium, titanium alloys, or stainless steel to be completely radiopaque. For such purposes, the part or component may be 3D printed by SLS. This may be desirable from the perspective of providing optional complexity (e.g., including braking features as described below), especially given the small size of the part and its features.

[0052] The teeth 40 used to grasp or secure the spring member within the anchor head body or base 31 can be made of metal. Such teeth have strength and radiopacity when made of stainless steel or Nitinol. Nitinol teeth may be beneficial in limiting the potential for bimetallic corrosion of the Nitinol spring member. In addition, greater design flexibility may be provided to include a detent feature by allowing greater deflection of the included element.

[0053] Figure 3A and Figure 3B The anchor head body or base 31 is shown prior to insertion of the cross teeth 40 and spring members 100 / 110 / 120 therein. The tooth, alternatively referred to as a (flat) cross pin or cross member, comprises a bridging portion or portions 42 and a deflectable latch in the form of an optional hook or tab 44 carried on a flexible arm or rod 46 which can be deflected inwardly (e.g. horizontally or left to right relative to the bottom or underside "U" of the body 31) when the tooth is inserted into the cross channel, track or tunnel 32 defined in the body 31. When the overhanging portion 48 of the tooth abuts the stop portion 33 in the body 31, the tab 44 locks into a complementary socket, recess or groove 34, as shown. Figure 4B shown.

[0054] Figure 4A A first stage of such insertion is shown, wherein the spring member body 100 / 110 / 120 is received by a transverse clearance hole or feed port or aperture 35 in the anchor head body or base 31 . Figure 4B is a cross-sectional view taken along the mid-plane of the cross-channel 32 and depicts the fully inserted or locked position of the teeth 40 relative to the anchor head and the multi-layer spring member 100 / 110 / 120. So positioned, each layer of the spring member body is securely secured within each engaged or captured unit 20 of the multilayer (their connector portions or segments 16 are visible in the cross-section) by the teeth 42 passing through the windows 22.

[0055] The teeth are advantageously carried by or incorporated in the anchor head prior to use. In other words, they are optionally contained within the anchor head so that they do not back out or otherwise inadvertently become separated from the anchor head before the teeth are advanced or deployed to penetrate and secure the spring member layer. The grooves 36 serve as a detent feature for this purpose. These grooves receive the hooks or bumps 44 and allow them to be released when the teeth are fully pushed into the anchor head. The grooves in the channel or track 32 can be formed by drilling (or molding) a cross hole 37 such as Figure 4A The parts shown are formed.

[0056] Other anchor head base and tooth configurations (with their combined stop and detent features) are also possible. For example, the flat surface of the tooth may include one or more protrusions that interface with the holes 37 for detent capture and release. To this end, the tooth may include first and partial (e.g., fixed and locked position) protrusions. Alternatively, additional detent holes may be included in the body or base 31 for a single protrusion on the tooth surface or even on the side thereof. Yet another option is to form a hole in the tooth and place a ball (e.g., made of PEEK or another plastic, elastomer, or stainless steel) in this hole to interface with one or more detent completion holes in the base.

[0057] Another such braking method is Figure 5A and Figure 5B 32 '. Here, the slidable teeth or cross pins 40 include a deflectable latch in the form of a flexible tang 46' that can move up and down relative to the flat underside U of the anchor head when passing through the channel 32. The lock will occur when the end 44' of each tang is received in a recess or receiver 34' formed in the anchor head body. As for the detent feature, it is provided by the interaction of the tang 46' with the recess or cavity 36' machined or molded from above (e.g., as shown in conjunction with the slot 37').

[0058] In addition to the advantages of incorporating the optional detent feature, an important aspect of the anchor head design relates to the sliding accommodation of its teeth within the base. This configuration enables the ends of the teeth to pass completely through and through multiple layers in the spring member. Positioned so, all of the spring member layers 10 are directly supported or secured by the bridging portions 42 of the teeth.

[0059] While it is important that the bridging portions 42 support or secure each spring member layer 10, it is equally important that the bridging portions cross or bridge the spring member feed ports or apertures 50. This arrangement provides support for each side of the teeth, providing strength to the interface. Optional chamfers or lead-in features 39 (in the body or base 32) for spring member accommodation may be machined or molded into the body or base 32. Figure 5B These features can be used as shown in Figure 1. Figure 5B and Figure 6B The angled surfaces may be of the form shown, or they may be as Figure 8 The curved or cupped feature shown.

[0060] in any case, Fig. 6A is a perspective view of an upper or outer body member or portion 31A of another exemplary embodiment of an anchor head. Figure 6B is a perspective view of its lower or inner body portion 31B. When connected, they form a body 31 '' for the anchor head 30 '', as shown Fig. 11B and Fig. 12BEach of the is shown (in cross section).

[0061] This connection or attachment can be achieved by an interference fit between a peg, post or pin 50 in a socket or recess 51 (or through hole) in part 31B. Or the pin can be carried by body 31B and a socket or through hole made in part 31A. Either way, the pin can be round, hexagonal or D-shaped, as shown, including a flat surface to allow air to flow out of the socket (as shown) during the press fit.

[0062] The main body or part 31A includes a spring member feed opening or aperture 35 and a slot 32', which defines a passageway that is closed when the main body parts 31A and 31B secure the parts together. The main body or part 31B also includes a feed opening 35 that aligns with the feed opening of its complementary part. In addition, the main body 31B includes one or more recesses or grooves 52 to accommodate the deflectable latch portion of the tooth to be used.

[0063] Each such recess may serve a purpose comparable to 34 / 34' and 36 / 36' in the previous embodiment. The symmetrical shape and / or placement of recess 52 may facilitate assembly (no orientation of the parts relative to slot 32).

[0064] In another optional aspect, one (or both) of the components 31A and 31B may include side cut regions 54 to create ledges 55 to define opposing side slots 58 (eg, Fig. 11B and Fig. 12B ), for separating the anchor head from the base when the components are assembled (ie, fixed together). A ramp portion 56 may also be included to facilitate removal of the anchor loader.

[0065] The base or underside (U) of part 31B may include one or more spring member lead-in portions 39. These may be chamfered surfaces as described above for the anchor head, or may be similar to Figure 8 shaped as a set of concave or cup-shaped surfaces, as shown in the anchor head 30'.

[0066] To facilitate handling and use of the anchor head as further described below, an anchor loader and pin / tooth pusher apparatus may be required. Fig. 7A and Figure 7B This device is described in detail. It is derived from U.S. patent application serial number 16 / 728,851 Figures 9A-11C A modification of the related loader shown in , in which a pin pusher lever arm or beam as shown is added.

[0067] More specifically, the plunger-type loader or loading tool 70 includes a tunnel or through hole or bore 72 to allow the spring member body to pass through. It also includes a plurality of flexible extensions or "fingers" 74 having depending catch portions or tips ("nails") 76. An undercut ramp portion 78 at each tip allows the anchor to be released when desired by pulling it away from the anchor after the loader is positioned and the anchor is locked. The fingers are narrow and thin enough to allow the necessary flexure to accommodate such action. Eight separate fingers are shown, but as few as three (usually symmetrically arranged) may be used to advantage.

[0068] The handle or body portion 80 of the plunger can be box-shaped or otherwise configured (e.g., rounded or round). A lever arm 82 is connected to the body. It can bend toward the body 80 and include a tip 84 of reduced width and / or rounded angles that is configured to push against a tooth housed in an anchor head having a surface 86. The connection 90 between the body 80 and the lever arm 82 can be configured to function as a so-called living hinge. An insertion grip or locating location 92 can be included in each feature.

[0069] Additional optional features are available in Figure 8 The anchor loader embodiment 70' (fixed anchor 30') is depicted in FIG. Fig. 9A and Fig. 9B (without anchor head) is further detailed in the cross-section view. Fig.10 A cross section of the same system is shown with the spring member body 100 / 110 / 120 housed within an anchor 30' secured by an anchor loader 40'.

[0070] Regarding the inventive feature, the lever arm 82 includes a notch or groove 88 formed to stabilize the interdigitated teeth 40' during insertion. The groove can be straight, or radiused to match the curvature of the ends 48 of the teeth (which themselves are so configured to match the curvature of the anchor body 32 / 32'). In addition, the loader embodiment 70' is configured to provide indexing operation relative to the spring member body housed therein.

[0071] This action is accomplished in conjunction with a detent feature. In one exemplary embodiment, each of the inserts 130 and 130' includes an inwardly directed protrusion 132 that interacts with the side or end connector 16 of the spring member body to be received in the loader. This element relationship is as follows Fig.10 shown.

[0072] In the figures, a "V" shaped protrusion 132 is provided. These are placed or nested between adjacent cells 20 when the body 100 / 110 / 120 is pushed or pulled through the anchor loader 70'. The angle of the V-shape, the size of any radius or flat surface at the apex of the V-shape, and the length of the inserts 130 and 130' (and therefore, the depth of the protrusion) can be configured so that positive engagement is felt (e.g., a tactile response is felt). In this embodiment, the protrusion 132 acts as a detent feature, and a response is felt as the spring member flexes as the cells 20 of the body 100 / 110 / 120 pass over the protrusion 132, causing the protrusion 132 to stop in a stable equilibrium position in the gap between adjacent cells 20. In such an arrangement or configuration, the spacing between the detent feature and the anchor contained in the loader is such that when in such a position, the cross teeth or pins 40' of the anchor align with the "window" 22 of the spring member for successful deployment.

[0073] Therefore, the convenience of this feature is significant. In the solution, using two (or more) braking features is also optional. However, it can be used with one insert, so a single insert can be used.

[0074] Furthermore, the orientation of the detent feature (or simply "detent") may be varied. For example, it (or they, if plural) may be arranged in a perpendicular plane relative to those described so that interaction with the spring member is through its face and window 22 rather than along its sides, as in Fig.10 In this case, it may be advantageous for the insert to be flexible (e.g., using a NiTi alloy "card"), since the inlet and outlet of the window involve interfacing with square edges (whereas the spring member may be circular - as shown - which naturally facilitates transition or translation of the spring member relative to the detent feature).

[0075] With respect to the configuration of the insert defining the illustrated detent feature, the base 134 that fits into a corresponding socket 136 created in the cartridge body may be oval to guide the orientation of the V-shaped extension 132. Otherwise, the insert base may be cylindrical and orientation handled in some other manner (e.g., by a slot for indicating or turning the insert like a screw head).

[0076] This device relies on the flexibility of the spring member (and the clearance of the bore 72 in the body 80 to allow bending) to provide spring action through the detent feature in this embodiment. Therefore, in this embodiment, the loader 70' does not include a separate spring member on which to mount or ride the insert 134, which would otherwise allow fore-and-aft sliding movement when the unit 20 moves past the protrusion 132. However, in alternative embodiments, the loader 70' may include a spring or other biasing member that allows the insert 134 or the protrusion 132 itself to move back and forth. In other words, the detent itself may be spring loaded. Further, the shape of the detent may vary depending on the material from which it is made. Stainless steel, NiTi, PEEK or other materials may be selected.

[0077] The difference between embodiments 70 and 70' is shown in relation to the so-called fingers 74 and 74'. In loader 70', those fingers 74' that oppose the downward push of lever 82 are connected together with the cross pins or teeth 40'. In other words, in embodiment 70', a partial cup 74' is provided, which may include a depending catch edge 76', as shown.

[0078] The body and / or insert of the anchor loader may be injection molded or machined for manufacture. The body of the anchor loader may include a textured surface or additional features for the user to grip. The arming of the device (i.e., inserting the anchor into the loader) may be done manually by the user, or may be done in advance so that the anchor and loader or plunger are provided in a "kit".

[0079] Back to Fig. 6A and Figure 6B , the anchor loader (whether or not it includes the described detent feature) may include an optional (shown in phantom) meter or counter 96. It may use a flap or spur-gear mechanism located inside the body 80 that interfaces with the window or aperture 22 of the body through which it is fed. In use, the end of the loader is advanced until the anchor contacts the bone or plate in which it will be used. Then, either 1) the optional button 96 may be pushed to engage the flap or spur gear with the body, or 2) the button may be pushed to zero the meter or counter 98.

[0080] As a counter, it can indicate the number of cells pulled to tension the body (by counting the windows or orifices). As a meter, it can display an estimate of the tension or compression force. This is possible if the loader (or the entire system) is selected to achieve the expected effective length of the spring member between the anchors - which can be determined under X-ray or using a calibrated C-clamp or custom measuring tool.

[0081] The readings may use an analog counter wheel, an analog type scale, or a digital counter or display. In addition, while simple mechanical devices (e.g., flaps or spur gears) have been disclosed to interface with the body 100 / 110 / 120 to count cells or estimate tension, electrical (analog or digital) devices may be used instead.

[0082] Fig.11A is a perspective view of an anchor loader embodiment 140 including an active (ie, spring loaded) braking feature and a locking collar 150 . Fig. 11B yes Fig.11A 1 and 120 with the anchor head 30" and a portion of the spring member 100 / 110 / 120 added as shown. As seen in each view, a detent tooth or claw 132 is provided (e.g., integrally formed) at the end of a lever arm 142 that extends in a cantilevered manner from a junction 144 with the remainder of the anchor loader body 80. Embodiments of the present invention may include two such detent features, as shown, or may be a single-sided design.

[0083] Regarding their function, each detent may need to be inserted to provide tactile feedback when the spring member passes over the same detent. For example, when the loader is made of nylon, PEEK or other engineering plastics, 0.003 inches of insertion (interference) may be required. Fig. 11B Such a configuration undergoes inward and outward motion (with associated tactile resistance), as shown by the double-headed arrow shown in .

[0084] Whether or not this approach is chosen, the lever arm includes a protuberance or ramp 146 to be urged inwardly when the sleeve 150 is brought toward and (optionally) over the claw 132 into contact with a stop area 152 of the body 80. In this position, the anchoring tooth 40' is aligned with the opening 22 of the spring member body for deployment therethrough.

[0085] From an ergonomic point of view, gripping features 154 can be provided along the sleeve. Fastener features 156 can secure the sleeve to the body 80. For assembly, these components can simply snap into place.

[0086] For manufacturing, the body 80 may be provided as a single piece, particularly if it is to be constructed using SLS or another additive manufacturing approach. For production by machining or injection molding, the body may be produced as two or more parts that may be press-fit or snap-fit ​​together, or secured with fasteners (e.g., as described with respect to the loader 140', as described below). The dashed dividers or parting lines indicate one such option of how the subcomponents of the body may be configured (partially) and ultimately fit together.

[0087] Fig. 11C The configuration of the anchor loader 140 body is detailed as comprising separate body parts 80A and 80B. This arrangement is designed for production by machining or injection molding. These parts are assembled as shown (arrowed) using a press fit between the pin 50 and the socket 51. The interface between the rod 158 and the channel 159 also contributes to the stability of the fit between the parts 80A and 80B.

[0088] Another notable feature is the shape of the sockets. They may be asymmetrical in design to provide a round, close-fitting (locating) pin / socket combination and three pins to be received in slot-shaped sockets for manufacturing process variations. As shown, the long axes of these slots are all oriented toward the locating pin / hole combination to minimize over-restriction on fit.

[0089] After assembly, the main configuration of this device is as follows Fig.11A As shown (if you ignore the Fig. 11C The draft angles of different angles are shown in FIG. 1 , and when the two-part body is configured for machining, the draft angle can actually be omitted). However, the configuration of the so-called fingers and tips used to secure the implant anchor may be different (e.g. Fig.11A and Fig. 11C ). Fig. 11C The so-called "cup" portion of the part is omitted, and the volume of finger 74' is increased relative to finger 74 (resulting in higher stiffness), and ramp angle 78' is reduced relative to ramp angle 78 to help the lower finger retain the anchor during tooth / cross pin advancement while still allowing the anchor to be released (although the release force is slightly higher when pulling the loader from the anchor after deployment). When considering the manufacturability of the design, the elimination of the cup can reduce molding and / or machining challenges.

[0090] Regardless of the details of the configuration, in use, the physician can pull tension on the spring member body 100 / 110 / 120 between a previously installed anchor and the tip 76 of the loader device 140 placed against the subject's anatomy or an orthopedic plate applied thereto. Due to the tension in the system, the collar 150 can translate forward, thereby locking the locking pawl 132 with the side of the spring member between its end connection 16. So locked, the physician can physically check the tension of the device and / or radiographically confirm the desired reduction in the anatomy between the system anchors. If in a tensioned state, the sleeve or collar 150 can be returned to its original position, the spring member further tensioned and locked again. Once the physician is satisfied, the lever arm 82 is actuated by the thumb positioned against the handle 94, deploying the slidable teeth 40' through the anchor body 32'' through the opening 22 of each cell 20 in the multi-layer spring member construction 100 / 110 / 120. Finally, the excess spring member body length is trimmed off.

[0091] and Fig. 12A and Fig. 12B Similar operation is possible with respect to the anchor loader 140' shown. However, this system includes a gear that meshes with a spring member. Although not shown, a lock may also be included.

[0092] However, for the general approach of the gears 160, their advantage is that they roll with the spring member in constant positive engagement between the units 20 on each side connector 16 and between each side connector 16. The meshing between the gears and the spring member can be smooth or eased by a detent feature. In one example, the detent includes a claw 132 located at the end of a flexible lever arm 142', which is very similar to the previous embodiment except that the claw interacts with the teeth 162 of the spur gear. In another approach, a socket or recess 164 can be machined in the surface of the gear. These can interact with ball detent features carried or incorporated by device body features (not shown). In any case, the detent feature can be spaced from the gear to align with any of the multiple windows 20 in the spring member body 100 / 110 / 120 for the anchoring tooth 40' to be accommodated.

[0093] Other optional construction details include having Fig. 12A The two-piece body construction of the body halves 80A' and 80B' shown. These halves can be fixed to each other by press pins or screws received in holes 148. This construction is suitable for production by machining or molding. However, this embodiment 140' and other embodiments described above can be produced using so-called rapid prototyping or 3D printing technology (including SLS, SLA or FFF). In fact, an operative device has been produced by its assignee.

[0094] Yet another optional detail relates to the manner in which the gears are secured within the device. In one approach, the gear axis 166 can be housed within a socket tab 170 connected to the gear housing 172 by a flexible arm 174. This arrangement allows the gears to be snapped directly into place, rather than inserting them and then pinning them (optionally by press fitting) into place.

[0095] It is also worth noting that the distal end of the loader may include "fingers" 74 with depending "nails" 76 that interface with the aforementioned optional side slots in the anchor head. These may be configured as shown to engage the opposing middle slots 58 in the anchor body 31 ''. Alternatively, such features may be configured as in the previous embodiments.

[0096] Regardless of the configuration, the loader 70 (or loader 70', 140 or 140') may be pre-assembled or loaded with the anchor 30 (or 30' or 30'') and used as described above. Fig.13 The packaging combination or kit 300 shown is provided in a thermoformed tray 310, which is typically sealed by TYVEK or another cover (not shown). The entire treatment system will also include the spring member 100 (or another such member 110 or 120). As described above, the spring member can be connected to the Beath needle 310 (or other introducer or guide). As shown, the needle is attached (via the tab 24 and eyelet 26) using a polyester suture material 320 that is contained and fixed (e.g., by swaging) in the proximal end 322 of the needle.

[0097] Medical treatment

[0098] As the injury (e.g., fracture or sprain) is reduced to the anatomical site, one or more of the embodiments of the device of the present invention are installed through the incision and pre-drilled holes. In the case of application or installation of the device, tensioning can be achieved due to slight rebound of the anatomical structure after manual compression or reduction of the anatomical structure with a clamp. Alternatively, device tensioning can be achieved as Fig.14 The process is completed as shown, during which a modified cable tie tool or so-called "cable tie gun" can be used to automatically or semi-automatically tighten and / or trim the tensioned spring member body. Such an instrument may include a spring-based dynamometer or a digital dynamometer (additional details of the latter are provided below) and an analog or digital indicator or light display (e.g., a green / yellow / red LED) to prompt the user to follow the following method.

[0099] Specific reference Fig.14 The actions or steps in the illustrated method 300 may be followed by an optional calibration step at 410. This may be performed during manufacturing by a user who intends to implement the tensioning method of the apparatus or system of the present invention.

[0100] More likely, at 420, after setting the distal anchoring position (which may be the anchoring head or anchoring foot, e.g., medially during a joint repair procedure), the proximal anchoring position is set (e.g., laterally during a joint repair procedure). Then, at 430, the spring member is engaged or grasped (by the surgeon directly using forceps or a dedicated tensioning instrument). Alternatively, the order of these operations may be reversed.

[0101] Either way, the spring member body is pulled or retracted at 440. This provides or allows for testing of the tension applied to or on the spring member at 450. This test can be a relative or tactile test performed by the surgeon, but is preferably quantified by digital or analog hardware, as discussed in various aspects.

[0102] If the tension is not as desired, it is adjusted at 460 by pulling in or out the length of the spring member relative to the anchor head. Whether or not optional step 460 occurs, the anchor head components are locked together at 470 (eg, using one of the sliding teeth and detent mechanisms described above).

[0103] Regardless of how the preload application is accomplished, excess spring member length is trimmed (e.g., using a flush cutter or cutting claws integrated into the tensioning device) so that the remaining structure is flush with the anchor head. Thus configured, the device of the present invention remains active to provide continuous compression, allowing anatomical movement across a joint or providing a less stressful alternative to hard screws for fractures. Finally, as described above, suitable medical methods of use that also apply to embodiments of the present invention are described in U.S. Pat. No. 10,194,946. Figure 8-15C Described.

[0104] Experimental Results

[0105] Results from cyclic fatigue testing and modeling of a number of spring members and spring member components are shown below. The spring members were all laser cut (each using fiber laser technology) from superelastic Nitinol sheets in identical flat or planar shapes or patterns and electropolished to remove approximately 0.001" of material per side. Therefore, the material thickness in device production (along with any associated bulk material properties) was considered an important variable for comparing cyclic fatigue life. In other words, an effort has been made to provide a realistic set of comparisons below when testing device performance and making associated performance estimates.

[0106] Test conditions AD

[0107] The first set of tests conducted on samples classified according to the test condition types (Test Con.) AD are reported in Table 1 and take into account the sample type, the overall thickness of the sample in inches (in) and millimeters (mm), the approximate preload (Preload) applied to the sample in Newtons (N) and grams (g) or kilograms (kg) of force, the axial displacement (Axial Disp. / Cell) applied to each cell 20 in mm, the number of cycles achieved (under the conditions noted), and relevant comments to provide additional context. The one-piece sample of Test Con. A is in Figure 1A The single layer configuration depicted in , but with an aspect ratio of beam thickness (T) to width (W) of approximately 5:1, with the thickness dimensions noted in Table 1 below. The single layer of Test Con. B is also in Figure 1A The thickness dimensions are noted in Table 1, and the figure actually shows an aspect ratio of 1:1. The five-layer configuration samples of Test Con.C and Test Con.D are in Figure 1B (without the additional layers 102, 104, 106), wherein each of the five layers has an aspect ratio of 1:1 and an overall thickness of the five layers summed or added together (see Figure 1B T t ), the dimensions are shown in Table 1. The samples were tested as follows:

[0108] .

[0109] A number of observations were made from the test data summarized above. Most unexpectedly, a five-fold (5x) reduction in device layer thickness can improve fatigue life by as much as 100x (or more). This can be seen in a comparison of Test Conditions A and B, with the latter achieving 95x the Test Con.A average number of cycles (i.e., 17,550) when testing was terminated prior to device failure. Because Test Con.B was terminated prior to device failure, this comparison could have been exceeded. Similarly, four of the five layers in the sample in Test Con.C achieved 98x the Test Con.A average number of cycles when Test Con.C was paused. When challenged under Test Con.D, 100x the number of cycles was achieved before any additional layers in the layered construction failed. Notably, the ultimate failure of the additional layers under Test Con.D occurred under more severe testing. Continuing with the original 0.028 mm / unit cycles under Test Con. C, it is reasonable to believe that the cycle life of the test article would further exceed the fatigue life of the one-piece design by a factor of 100 (assuming that the test was terminated before the spring member broke, so the results reported are so-called "runout" values). In any case, the improvement in fatigue life observed in Test Con. BD represents an improvement of two orders of magnitude relative to the results of Test Con. A. In other words, the designed specimens differed only in thickness, which unexpectedly resulted in the thinner specimens being able to consistently achieve runout under the applied test conditions.

[0110] Regarding this consistency and the apparent potential for early failure of a given single-layer specimen (e.g., in Test Con. C), it is important to note that such breakage in a multilayer construction does not significantly degrade overall device functionality. This is especially true for the anchor heads described herein, which even continue to hold broken layer fragments. The only expected consequence is a slight, proportional decrease in available compressive force.

[0111] Length-dependent tests

[0112] The samples configured as above were further tested. In this test, a single "one-piece" (i.e., 1 mm thick) spring member was tested, as well as a single 0.2 mm device "layer." The one-piece samples were tested at lengths within the tabulated range with a 2.5 lbf preload applied; the single-layer samples were tested at lengths within the tabulated range with a preload of one-sixth of the 2.5 lbf applied (given their intended clinical use in a six-layer configuration as described herein).

[0113] Table 2 shows the estimated fatigue life of a representative median (i.e., 50th percentile) device generated by a regression analysis fitted to the data generated for the sample sizes of the nine one-piece design specimens. In the table, the bold values ​​at the top represent the total displacement applied in mm, and the bold values ​​on the left represent the length of the device subject to this displacement. The values ​​in the table (i.e., the number of cycles expected before failure) follow the highly predictable decline in fatigue life in the original data associated with increasing displacement applied relative to the device length.

[0114]

[0115] Table 3 was generated in the same manner as Table 2 (i.e., also shows estimates for the 50th percentile devices based on the test data), with a slightly larger sample size (i.e., with 10 device layer samples). Again, the bold values ​​at the top of the table represent the total displacement applied in mm, and the bold values ​​on the left represent the length of the device subject to such displacement. Similar trends to those presented in Table 2 are observed, but for some of the tabulated conditions, the fatigue performance of the layers in the multilayer design is significantly improved, exceeding 1,000,000 (1M) cycles.

[0116]

[0117] Furthermore, the results in these two tables are generally consistent with those in Table 1. (For comparison between the tables, the approximate displacement of each cell in each design for any given entry in Tables 2 and 3 (since each cell is approximately 1 mm long) can be obtained by dividing the selected device length by the applied displacement.)

[0118] Additionally, it should be noted that the estimates in Tables 2 and 3 represent the time that a single device layer might fail. In other words, this performance does not take into account redundancy in multi-layer designs, where one or more layers might fail while the entire device remains intact.

[0119] Furthermore, it can be seen from Tables 2 and 3 that the fatigue life of the samples decreases with the displacement applied per unit device length. However, various design parameters in the spring member pattern (i.e., the cutting pattern used to produce the device of the present invention) can be changed to improve this effect in shorter implant devices. Specifically, Figure 15A-Figure 15C Applicable spring member configuration changes are shown to increase the cell count per unit device length (thereby reducing the axial displacement per cell for a given device length) without introducing other overall performance-altering changes.

[0120] Fig.15A The length of the spring member pattern A is shown. Pattern A corresponds to that shown in the figure and was used in the above-mentioned tests. Fig. 15BThe difference between pattern B and pattern A is that it reduces the length of the bridge 18 (L br ) and the width of the opening or window 22 (W w ). Fig. 15C Drawing C in FIG. 1 incorporates a variation of Drawing B and also inserts the position of the bridge 18 relative to the external connector 16 (resulting in a bent rod or beam member 14 shape or a "light bulb" shaped unit end). Fig.15A As shown, Pattern B adds 3 units to the equivalent length of 12 units in Pattern A, for a total of 15 units; Pattern C adds 4 units to the same relative length, for a total of 16 units. Therefore, using Pattern C in the spring member will result in the device experiencing the same displacement per unit at a length of 45 mm as a 60 mm device using Pattern A.

[0121] Another way to reduce the strain per unit cell for a given displacement and effective length of the spring member is to reduce the width (W) of the bridge 18. br ). This increases the relative length of the included rod or beam 14 for a spring member body of the same width compared to another spring member body that is not changed, thereby providing the possibility of the same axial deflection with reduced peak stress and strain. Alternatively, (or additionally) a longer beam 14 may be used to increase the overall pattern width. However, doing so may require a larger pilot hole. It should therefore be clear that the selected design involves many competing variables.

[0122] Naturally, further changes in the spring member pattern can be applied to further improve the cyclic fatigue life in shorter device lengths. In addition to the large number of changes described, shape refinement guided by finite element analysis (FEA) is certainly possible. In any case, for the multi-layer device of the present invention, it may be desirable to participate in such a pattern design or selection so that the implant of any length to be used is subjected to less than about 0.025 and about 0.030 mm axial displacement per unit, and in particular less than 0.027 or 0.028 mm axial displacement per unit, as designed as shown. In addition, as contemplated within the scope of the present invention and its embodiments, these values ​​vary with different unit configurations.

[0123] Digital Hardware

[0124] The tension or associated compression measurement force readings in the method of the present invention can be obtained using commercially available electronic hardware. Strain gauges and piezoelectric sensors for measuring compression and / or tension pulled between parts of a sensor substrate or interface are well known. These can be used herein.

[0125] If so, the calculations or processing performed in conjunction with the embodiments herein may be implemented or performed with a general or special purpose processor or processing circuit, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof, designed to perform the functions described herein. A general purpose processor may be a microprocessor, but in an alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. The processor may be part of a computer system that also has a user interface port that communicates with a user interface and receives commands entered by a user, has at least one non-transitory memory (e.g., a hard drive or other similar memory, and random access memory) that stores electronic information, including programs that run under the control of the processor and communicate through the user interface port, and produces video output of its output through any type of video output format (e.g., VGA, DVI, HDMI, USBC, DisplayPort, or any other form).

[0126] A processor may also be implemented as a combination of computing devices, for example, a DSP and a microprocessor, a plurality of microprocessors, a combination of one or more microprocessors in conjunction with a DSP core, or any other such configuration. These devices may also be used to select values ​​for the devices described herein.

[0127] The steps of the method performed by the electronic device described herein can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions can be encoded as instructions and data in a non-transitory computer-readable medium (e.g., computer memory). When executed by a processor, the encoded instructions can cause a device, such as a flow sensor, to perform the method described herein. Computer-readable media include computer storage media and communication media, including any medium that facilitates the transfer of computer programs from one place to another. Non-transitory computer-readable media may include any non-transitory medium suitable for access and decoding by a computer. By way of example and not limitation, such non-transitory computer-readable media may include RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to encode the required program code in the form of non-transitory instructions or data structures and can be accessed by a computer. The memory storage may also be a rotating magnetic hard drive, an optical disk drive, or a flash-based storage drive or other such solid-state, magnetic or optical storage device. In addition, any connection is properly referred to as a computer-readable medium.

[0128] The operations described herein may be performed on or through a website. The website may be run on a server computer or locally, for example, by downloading to a client computer, or through a server farm. The website may be accessed through a mobile phone or PDA or any other client. The website may use any form of HTML code, for example, MHTML or XML, and through any form, such as cascading style sheets ("CSS") or other forms.

[0129] change

[0130] Various aspects of the subject matter of the present invention are set forth below to review and / or supplement the embodiments described so far, with emphasis on the interrelationship and interchangeability of the following embodiments. In other words, emphasis is placed on the fact that each feature of an embodiment can be combined with each other feature unless explicitly stated otherwise or logically implausible.

[0131] In many example embodiments, a device is provided, comprising: a spring member comprising a plurality of layers fixed together, wherein each of the plurality of layers has an elongated tensile structure with two transverse outer extensions, and wherein each of the plurality of layers comprises a plurality of beams arranged in pairs, wherein a first beam and a second beam in each pair are connected to each other only at the two transverse outer extensions, such that the first beam is opposite to the second beam, and wherein each pair of beams is connected to an adjacent pair of beams only by an intermediate connector, such that there is a gap at the two transverse outer extensions between each pair of beams and the adjacent pair of beams. The beams and connectors at the beam outer extensions may form a shape selected from a rectangular, square, racetrack, elliptical, and circular shape.

[0132] In any and all of these embodiments, the spring member layer (and the entire stack construction) advantageously comprises a SE NiTi alloy.

[0133] In any and all of these example embodiments, the spring member layers may be separate layers secured together by at least one weld.Only one weld may be provided, and the weld may be at an end of the spring member.

[0134] In any and all of these example embodiments, each layer of the plurality of layers has a thickness of approximately 0.01 inches (0.25 mm), such as, for example, between 0.008 inches (0.20 mm) and 0.012 inches (0.30 mm).

[0135] In any and all of these example embodiments, the beam has a width to thickness ratio of between about 2:3 and about 3:2. The ratio may be about 1:1.

[0136] In any and all of these example embodiments, the spring member includes at least 2 layers or 3 or more layers, at least 4 or more layers, at least 5 or more layers, at least 6 or more layers, or no more than and no less than 3, 4, 5 or 6 layers.

[0137] In any and all of these embodiments, the apparatus may further comprise an anchor foot comprising a first end, a second end, and a pivot hole therebetween; longitudinal extensions extending from the distal end of each layer of beams, the distal end of each longitudinal extension comprising an aperture; and a pin received by the anchor foot pivot hole and the aperture in each longitudinal extension.

[0138] In any and all of these embodiments, the apparatus may further include: an anchor foot including a first end, a second end, and a pivot hole therebetween; a first spring member sheet folded about a fold to form two spring member layers; and a pin received by the anchor foot pivot hole and at the fold of the spring member sheet. The apparatus may further include a second spring member sheet folded over the first spring member sheet. The apparatus may further include a third spring member sheet folded over the second spring member sheet.

[0139] In any and all of these embodiments, the device may also include an anchor head. The anchor head may have a body and teeth slidably received therein, wherein the teeth are configured to pass through the multiple spring member layers. The body and teeth may be configured to lock with each other when the teeth advance to a locked position within the body. A deflectable latch may be provided for this purpose. In one example, it is in the form of a flexible arm hook that can move left and right relative to the base of the anchor head. In another example, the latch is in the form of a deflectable tang that can move up and down relative to the base of the anchor head. In each case, the end of the latch will lock when it is received in a recess or receiver formed in the body of the anchor head.

[0140] One or more of these anchors (depending on whether the spring member has a foot attached thereto, as in some embodiments) are included in the packaged combination as part of a system or kit. Optionally, the anchor is pre-set or fixed in a loading device configured to releasably retain the anchor. Such a device advantageously includes a lever arm that is capable of moving and deploying the sliding teeth or cross pins of the anchor before the anchor is released. A braking feature is also advantageously included to assist in use. Specifically, including such a feature advantageously allows the anchor and the spring member body to automatically align to deploy the sliding teeth or another cross member.

[0141] For example, in any and all of these embodiments, the system may include at least one anchor loader for applying an anchor to a spring member, the loader comprising: a body including a tunnel configured to accommodate the spring member, a plurality of flexible extensions extending from the body, each flexible extension including an upwardly extending tip configured to retain the anchor; and a lever arm connected to the body, the lever arm being movable toward the body and including a tip configured to push the anchor teeth of the anchor head into a final position. The anchor loader may also include at least one braking feature positioned to interact with the spring member to align any of a plurality of windows in the spring member body for anchor teeth accommodation. At least one braking feature may be positioned to fit between adjacent connectors along a lateral outer extension of the spring member. At least one ratchet braking feature may be integrally formed with the oval base. The system may include two braking features. The spring member, the anchor loader, and the braking feature may be configured to operate without applying a spring load to the braking feature. In any and all embodiments, at least one braking feature may include a V-shaped extension.

[0142] In any and all of these embodiments, a method of tensioning a medical device of the present invention (or a device of similar function) may include setting a position of a proximal anchor, receiving a spring member through the proximal anchor, pulling the spring member to test the tension of the spring member, adjusting the tension of the spring member by pulling an additional length of the spring member through the proximal anchor or allowing a certain length of the spring member to retract through the proximal anchor, and locking the proximal anchor. In the method, a digital dynamometer may be used to test the tension of the spring member. Alternatively, the anchor is applied to the spring member received within the anatomical structure that is reduced (manually or with a clamp) without applying such tension or preload.

[0143] Where a range of values ​​is provided, it is understood that each intervening value between the upper and lower limits of such range and any other stated or intervening value in the stated range is encompassed within the subject matter of the invention. In addition, it is contemplated that any optional feature of the described inventive variations may be set forth and claimed independently or in combination with any one or more of the features described herein. Furthermore, no limitation in the specification should be construed as limiting any claim unless such limitations are expressly included in the claims.

[0144] As used herein and in the appended claims, the singular forms "a," "an," and "the" include plural referents unless the context clearly dictates otherwise. In other words, the use of article permits "at least one" of the subject matter items described above and in the following claims. A claim may exclude any optional element. Therefore, this statement is intended to serve as antecedent basis for the use of exclusive language such as "solely," "only," and the like in connection with the recitation of claim elements, or the use of a "negative" limitation.

[0145] In the absence of such specific terms, the term "comprising" in the claims shall allow the inclusion of any additional elements, regardless of whether a given number of elements are recited in the claims or the addition of a feature may be regarded as changing the nature of the elements recited in the claims.

[0146] The disclosures discussed herein are provided only for their disclosures prior to the filing date of the present application. Anything herein should not be construed as admitting that the present disclosure is not entitled to be earlier than such disclosures based on prior disclosures. In addition, the publication date provided may be different from the actual publication date and may require independent confirmation.

[0147] The subject matter described herein and in the drawings is accomplished with sufficient detail and clarity to permit the inclusion of claims in means-plus-function format at any time pursuant to 35 USC Section 112, Part (f). However, a claim should be construed as incorporating such means-plus-function format only when the phrase "means for XXX" is expressly recited in a claim.

[0148] Although the embodiments are susceptible to various modifications and alternative forms, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that the embodiments are not limited to the specific forms disclosed, but rather, the embodiments will cover all modifications, equivalents, and alternatives that fall within the spirit of the invention. In addition, any features, functions, actions, steps, or elements of the embodiments may be stated or added in the claims, as well as negative limitations that limit the scope of the invention of the claims by features, functions, actions, steps, or elements that are not within the scope.

Claims

1. A bone and joint stabilization system comprising: A spring member comprising a plurality of layers secured together, wherein each of the plurality of layers has an elongated stretchable structure with two lateral outer extensions, wherein each of the plurality of layers comprises a plurality of beams arranged in pairs; wherein the first beam and the second beam in each pair are connected to each other only at the two transverse outer extensions, such that the first beam is opposite to the second beam, and wherein each pair of beams is connected to an adjacent pair of beams only by an intermediate connector such that a gap exists at two transverse outer extensions between each pair of beams and the adjacent pair of beams; and at least one anchor head, wherein the at least one anchor head has a base and an anchor tooth slidably received in the base, the anchor tooth being configured to pass through the plurality of layers, the anchor tooth comprising an overhanging portion, a bridging portion, and a deflectable latch, the base comprising a stop portion and a recess, the deflectable latch being locked in the recess of the base when the overhanging portion of the anchor tooth abuts the stop portion of the base, and each of the plurality of layers being secured by the bridging portion of the anchor tooth, Wherein the connections between the layers are located in areas of the spring member that can be trimmed and discarded after the spring member has been dimensioned, so that after trimming the layers will be secured at the ends by the anchoring heads.

2. The system according to claim 1, wherein: The plurality of layers are a plurality of individual layers secured together by at least one weld.

3. The system of claim 2, wherein the proximal and distal ends of the spring member are welded.

4. The system according to claim 1, wherein: Each of the plurality of layers has a thickness of 0.01 inches.

5. The system according to claim 4, wherein: Each of the plurality of layers has a thickness between 0.008 inches and 0.012 inches.

6. The system according to claim 1, wherein: Each beam of the plurality of beams has a width to thickness ratio between 2:3 and 3:

2.

7. The system according to claim 6, wherein: The ratio is 1:

1.

8. The system according to claim 1, wherein: The plurality of layers comprises at least 3 layers.

9. The system according to claim 8, wherein: The plurality of layers comprises at least 4 layers.

10. The system according to claim 9, wherein: The plurality of layers comprises at least 5 layers.

11. The system according to claim 10, wherein: The plurality of layers includes at least 6 layers.

12. The system according to any one of claims 1 to 11, wherein: The spring member comprises a NiTi alloy having superelasticity at human body temperature.

13. The system of claim 1, further comprising: an anchor foot comprising a first end, a second end, and a pivot hole therebetween; longitudinal extensions extending from distal ends of the beams of each layer, the distal end of each longitudinal extension comprising an aperture; and A pin is received by the anchor foot pivot hole and an aperture in each longitudinal extension.

14. The system of claim 1, further comprising: an anchor foot comprising a first end, a second end, and a pivot hole therebetween; a first spring member sheet folded about the fold to form two spring member layers; as well as A pin is received by the anchor foot pivot hole and the fold.

15. The system of claim 14, further comprising a second spring member sheet folded over the first spring member sheet.

16. The system of claim 15, further comprising a third spring member sheet folded over the second spring member sheet.

17. The system of claim 1, wherein: Each beam of the plurality of beams and the connector extending outside each beam form a shape selected from a rectangular shape, an elliptical shape, and a circular shape.

18. The system of claim 1, wherein: Each beam of the plurality of beams and the connector extending outside each beam form a square shape.

19. The system of claim 1, wherein: The base and the anchoring tooth are configured to lock with each other when the anchoring tooth is advanced to a locked position within the base of the anchoring head.

20. The system of claim 1, further comprising at least one anchor loader for applying the anchor head to the spring member, the at least one anchor loader comprising: a body including a tunnel configured to receive the spring member; a plurality of flexible extensions extending from the body, each of the flexible extensions comprising an up-extended tip configured to retain the anchor head; as well as A lever arm is connected to the body, the lever arm being movable toward the body and comprising a tip configured to push the anchoring teeth of the anchoring head into a final position.

21. The system of claim 20, wherein: The at least one anchor loader also includes at least one detent feature positioned to interact with the spring member to align with any of a plurality of windows in the spring member body for anchor tooth reception.

22. The system of claim 21, wherein: The at least one detent feature includes a V-shaped extension.

23. The system of claim 22, wherein: The V-shaped extension is positioned to fit between adjacent connectors along a lateral outer extension of the spring member.

24. The system of claim 22, wherein: The V-shaped extension is integral with the oval base.

25. The system of claim 22, comprising two braking features.

26. The system of claim 22, wherein: The spring member, the at least one anchor loader, and the at least one detent feature are configured to operate without spring loading the at least one detent feature.

27. The system of claim 21, wherein: The at least one detent feature of the at least one anchor loader is carried by a deflectable beam.

28. The system of claim 27, wherein: The at least one anchor loader includes a slidable collar configured to lock the at least one detent feature with the spring member.

29. The system of claim 20, further comprising at least one spur gear configured and positioned to mesh with the spring member along a lateral outer extension of the spring member between adjacent connectors.

30. The system of claim 29, further comprising at least one detent feature to interact with the at least one spur gear to align any of a plurality of windows in the spring member body for anchor tooth reception.

31. The system of claim 30, wherein: The at least one detent feature includes a claw at an end of a flexible arm.

32. The system of claim 1, wherein: The spring member is connected to the Beath needle.

33. The system of claim 32, wherein: The spring member is connected to the Beath needle by suture material.

34. A bone and joint stabilization system, the system comprising: a spring member comprising a plurality of layers secured together; as well as at least one anchor head, wherein the at least one anchor head has a base and an anchor tooth slidably received within the base, the anchor tooth being configured to penetrate the plurality of layers of the spring member; wherein each of the plurality of layers has an elongated stretchable structure with two lateral outer extensions; wherein each of the plurality of layers comprises a plurality of beams arranged in pairs; wherein the first beam and the second beam in each pair are connected to each other only at the two transverse outer extensions, such that the first beam is opposite to the second beam; and wherein each pair of beams is connected to an adjacent pair of beams only by an intermediate connector so that there is a gap at two transverse outer extensions between each pair of beams and the adjacent pair of beams, Wherein the connections between the layers are located in areas of the spring member that can be trimmed and discarded after the spring member has been dimensioned, so that after trimming the layers will be secured at the ends by the anchoring heads.

35. The system of claim 34, wherein: Each beam of the plurality of beams has a width to thickness ratio between 2:3 and 3:

2.

36. The system of claim 35, wherein: The ratio is 1:

1.

37. The system of claim 34, wherein: The spring member comprises a NiTi alloy having superelasticity at human body temperature.

38. The system of claim 34, wherein: Each beam of the plurality of beams and the connector extending outside each beam form a shape selected from a rectangular shape, an elliptical shape, and a circular shape.

39. The system of claim 34, wherein: The base and the anchoring tooth are configured to lock with each other when the anchoring tooth is advanced to a locked position within the base of the anchoring head.

40. The system of claim 34, further comprising at least one anchor loader for applying the anchor head to the spring member, the at least one anchor loader comprising: a body including a tunnel configured to receive the spring member; a plurality of flexible extensions extending from the body, each of the flexible extensions comprising an up-extended tip configured to retain the anchor head; as well as A lever arm is connected to the body, the lever arm being movable toward the body and comprising a tip configured to push the anchoring teeth of the anchoring head into a final position.

41. The system of claim 40, wherein: The at least one anchor loader also includes at least one detent feature positioned to interact with the spring member to align with any of a plurality of windows in the spring member body for anchor tooth reception.

42. The system of claim 41, wherein: The at least one detent feature includes a V-shaped extension.

43. The system of claim 42, wherein: The V-shaped extension is positioned to fit between adjacent connectors along a lateral outer extension of the spring member.

44. The system of claim 42, wherein: The V-shaped extension is integral with the oval base.

45. The system of claim 42, comprising two braking features.

46. ​​The system of claim 42, wherein: The spring member, the at least one anchor loader, and the at least one detent feature are configured to operate without spring loading the at least one detent feature.

47. The system of claim 41, wherein: The at least one detent feature of the at least one anchor loader is carried by a deflectable beam.

48. The system of claim 47, wherein: The at least one anchor loader includes a slidable collar configured to lock the at least one detent feature with the spring member.

49. The system of claim 40, further comprising at least one spur gear configured and positioned to mesh with the spring member along a lateral outer extension of the spring member between adjacent connectors.

50. The system of claim 49, further comprising at least one detent feature to interact with the at least one spur gear to align any of a plurality of windows in the spring member body for anchor tooth reception.

51. The system of claim 50, wherein: The at least one detent feature includes a claw at an end of a flexible arm.

52. The system of claim 34, wherein: The spring member is connected to the Beath needle.

53. The system of claim 52, wherein: The spring member is connected to the Beath needle by suture material.

54. The system of claim 34, wherein: Each beam of the plurality of beams and the connector extending outside each beam form a square shape.

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