TW202123888A - Strength and fatigue life improvements for active bone and joint stabilization devices - Google Patents

Abstract

Bone and joint stabilization devices or systems are described that include multiple-layer bodies. The approach offers dramatically improved fatigue life as compared to one-piece spring members that are otherwise similar or comparable. Coordinated improved-strength anchor embodiments, anchor loading tools and methods of use are also described.

Description

Used to improve the strength and fatigue life of movable bone and joint stabilization devices

The embodiments described herein are related to the field of surgery, and more specifically, the embodiments described herein are used in bone fusion, joint stabilization, and/or fracture fixation operations.

US Patent Nos. 10,194,946 and 10,555,766 describe embodiments of bone and/or joint stabilization devices that can be tightened during a medical procedure to stay active during use to maintain the associated anatomical compression. In many of these embodiments, an orthopedic surgical device or system includes an elongated member or body that includes a spring pattern with a plurality of beams, each beam includes a transverse member that is free to deflect when the elongated body is axially extended . The overall flexibility of the structure also allows the implant and the associated body structure to move in torsion, orthogonality, external and internal rotation, etc. to achieve a full anatomical range of motion.

An anchoring head can receive an elongated body and can use one or more teeth contained in a unidirectional (for example, ratcheting) interface to fix it. Two such anchors can be used or one such anchor can be used with one of the deployable anchors at one of the opposite ends of the elongated body. The mentioned "teeth" of the anchoring head can be partially received in the thickness of the spring component body or it can span the entire thickness of the spring component. Thereby, the teeth can be adjacent to one of the opposite walls of one of the feed openings in the anchor head or further extend out to be supported by the pair of convex parts.

The implantable devices involved in the patents cited below have been effectively used in the treatment of human patients. In these surgical procedures, it provides a novel and particularly useful tool for treating traumatic orthopedic injuries. However, design improvements that lead to higher ultimate strength and longer cycle fatigue life of certain components are still desired.

The embodiments or variants of the present invention are related to the above-mentioned embodiments, but are modified in various ways to achieve a significantly longer cycle fatigue life and/or ultimate strength of a particular component. U.S. Patent 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 describe useful spring component structures and anchors For details of the head, screw and foot features, the full text of all these patents are incorporated herein by reference for all purposes (especially the following will be cited in various ways).

More specifically, the embodiments herein include a nickel-titanium alloy (generally superelastic (SE) at human body temperature (ie, having an A _f lower than about 37°C) with a plurality of layers of finite thickness, NiTi Alloy) spring components, as will be described below. The method provides a significantly improved fatigue life compared to the original single-piece spring components of similar or equivalent total thickness. The multilayer spring component of the present invention can be used in the system described herein with one of (several) anchoring heads or one foot (such as the system cited above from the '964 patent (especially a system with a span across the entire thickness of the spring component body). Tooth system)) or another method. However, the embodiments and methods of use of the coordinated anchor head described herein may present specific advantages depending on the situation.

Devices, systems containing devices (or device components or sub-components) (assembled or unassembled), methods of use (for example, implantation during treatment of a patient, simultaneous correction and/or removal of the system) and manufacturing methods (including As the case may be, the assembly of various components by a technician before sales or by a surgeon during a medical procedure) are all included in the scope of the present invention. These systems may include the loading devices or tools described herein. The methods of the present invention (including use and/or manufacturing methods) can be implemented in any sequence of events and any listed sequence of events that is logically feasible. The medical method may include any of the operator activities associated with device provision, implant introduction, positioning and/or repositioning, and surgical access, closure, and/or removal (eg, as in the same explant procedure).

Cross reference of related applications This application claims the U.S. Provisional Application No. 63/001,107 filed on March 27, 2020, the U.S. Provisional Application No. 62/914,172 filed on October 11, 2019, and the U.S. Provisional Application filed on September 5, 2019. Application No. 62/896,302 and U.S. Provisional Application No. 62/837,579 filed on April 23, 2019, the full texts of all such cases are incorporated herein by reference for all purposes.

Various example embodiments are shown in the figures and described further below. With reference to these examples in a non-limiting sense, it should be noted that they are only used to illustrate the broader application aspects of the device, system, and/or method. Various changes can be made to these embodiments without departing from the true spirit and scope of the various embodiments and equivalents can be substituted. In addition, many modifications can be made to adapt a specific situation, material, material composition, program, (several) program actions or steps to the purpose, spirit, or scope of the present invention. All such modifications are intended to be within the scope of the patent application that can be made in this article. Exemplary embodiment of spring member

FIG. 1A shows an exemplary embodiment of a single layer 10 (also referred to as a body or constituent body or part) that can be stacked to produce or define a spring component structure 100 shown in FIG. 1B. As already mentioned (and will be described in more detail herein), the embodiment of the implant constructed using the spring component 100 has significantly and unexpectedly improved fatigue life than the original single-layer spring component of similar or equivalent total thickness.

As shown in FIGS. 1A and 1B, the layer 10 is in the form of a stretchable or spring-type structure including one of a plurality of beams or beam members 12. The beams 12 each include a transverse rod or beam assembly 14 that is free to deflect to axially stretch the spring component layer 10. The transverse rods 14 are provided as opposed pairs that are joined to each other at the outer extension connector 16 of each beam. In other words, the layer 10 may include a plurality of beams 12 arranged in pairs, wherein a first beam and a second beam of each pair are connected to each other only at two lateral extensions 16 such that the first beam and the second beam are opposed to each other. . Each connector 16 can be one of the rods 14 or beams 12 bent and connected or configured in other ways. Each pair of beams 12 is connected to an axially adjacent pair by an intermediate connector or bridge 18. Therefore, there is a gap at the two lateral extensions between each pair of beams and the adjacent pair of beams, as shown in the figure. The beams 12 or beam pairs serve as tandem leaf spring elements arranged in units 20, each having a central window or aperture 22.

The shape of these (integral or integrated) components can be presented as a racetrack configuration, as shown in the figure. In the same basic description above, various beams, rods, and connectors can be formed into substantially rectangular, elliptical, circular, or other configurations (for example, including more complex shapes, such as the stress shown in Figure 4B of USPN 10,194,946). Elimination features, as described below in conjunction with FIG. 9B and FIG. 9C or others).

In any case, an overall spring component or multilayer spring component construction 100 is shown in FIG. 1B. It can include one of welding or welding beads (WB) at either end (only one end is shown in the figure, but both ends can be welded). The bead or weld can be placed as shown in the figure to capture all layers or placed elsewhere to achieve the same result. In either case, welding is used to keep the individual or otherwise independent layers 10 together for easy handling until after anchor application and any finishing after setting the final position of the anchor. Alternatively, a preloaded anchor or button at one end (of the same type as described or another configuration, such as a welded all metal button) can hold the parts or elements together. In addition, the layers can be adhered, brazed or pinned together, die-forged in a ferrule or hypodermic injection tube, or fixed in a length of a heat shrinkable tube.

Regardless of whether it is provided by a welding, multiple welding points or other, the connection between the layers will usually be located in an area that can be repaired from the implant and discarded after setting the size. The layers of the final (i.e., shaped) spring component part of the implant will generally only be fixed or coupled (using an anchoring head or an attachment foot and an anchoring head) at their respective ends. Therefore, individual layers can work in a parallel spring configuration, but the failure of one layer (for example, due to cyclic fatigue) does not affect the performance dynamics of other layers.

That is, an implantable sheath can be used in the system of the present invention (for example, as described in US Patent No. 10,194,946). This sheath can surround the spring component layer and keep the spring component layer together in a given contour or envelope, but it generally does not lock them together or couple them along their equal lengths.

When additional axial force capability and/or a higher spring rate are required, a layer of a given thickness (generally (but not necessarily) having the same thickness as the thickness shown) can be stacked to define a thicker implant. Three such optional additional layers 102, 104, and 106 are shown in dashed lines in FIG. 1B. Conversely, according to an indication that less compressive force is desired, fewer layers can be stacked in a thinner implant. Generally speaking, according to the above logic, for redundancy when a single layer fails, at least two or more layers and preferably at least three or more layers are used.

As shown in FIG. 1A, a _{ratio of the thickness (T b} ) to the width (W _b ) of the beam member 12 in each layer may be about 1:1. This ratio can be relatively small or large (e.g. from about 2:3 to about 3:2) and still achieve fatigue benefits.

In terms of absolute dimensions relative to, for example, the NiTi material examples described herein, the beam thickness may be about 0.01 inches (0.25 mm). More specifically, it can be between 0.008 inches (0.20 mm) and 0.012 inches (0.30 mm) thick. Further variability is also possible. For example, when the layers are between about 0.013 inches (0.33 mm) and about 0.015 inches (0.4 mm) thick, the three-layer spring component body may prove to be fatigue resistant (and also provide some redundancy when one layer fails). With the benefits of the present invention, those skilled in the art can also achieve the equivalent size of other materials. Exemplary system or device embodiment

FIG. 2A shows a first overall device or system or embodiment 200. In this embodiment, two facing anchors or anchor heads 30 are used in combination with the spring member 100. Alternatively, the anchor head may refer to a button or a button anchor. In this embodiment 200, the spring member 100 may include lugs 24 each defining an eyelet 26 added. U.S. Publication No. 2019/0046253 and PCT Publication No. WO 2019/032231 disclose a similar lug feature, which is used to use a length of suture or other rope to fasten or otherwise fix an associated introducer ( Or "Beath") needle. Therefore, only one such lug/eyelet feature needs to be used in the device 200, but two such lug/eyelet features may be included for easy manufacturing and/or welding. FIG. 2A also shows how a plurality of individual tack beads (WB) can be used to fix the layers (in the case of this embodiment 200, six such layers) to each other.

In use, the needle passes through one of the clearance holes drilled in the bone and is used to pull the spring member through the clearance hole. Given the triangular shape of the associated lugs and perforations, the front end of the device self-aligns its center relative to the bone tunnel through which it passes. Finally, the lug(s) 24 are trimmed together with any associated extra length of the spring member 100 that holds the anchor head fixed after any tensioning. As with the patents and patent applications mentioned above, a flat cutter, a custom tool or other can be used to complete this trimming.

FIG. 2B shows a second device or system embodiment 210. It includes an anchor head 30 (as the case above) and a pivoting foot anchor 60 at the end of the spring member. Specifically, the embodiment 210 includes a straight axial or longitudinal extension 112 from each layer 10 in the spring component section 110. The extension of each layer includes a terminal hole 114. A single cross pin 28 is received through the eyelet and in the opposed hub 62 of the foot anchor. A press fit can be used to keep the pin in the hub. This method provides both simplicity and a given orientation of the anchoring foot relative to one of the widths of the spring member body.

FIG. 2C shows a third device or system embodiment 220. As in the embodiment in FIG. 2B, an anchor head 30 and a rotatable anchor foot 60 are used. However, in the device 220, the body 120 is rotated 90 degrees with respect to the orientation of the anchoring feet.

It may be expected that this orientation will be used to handle specific instructions. In addition, by laying one surface 64 of the anchoring foot 60 flat against its spring component body 120, the system 220 can be configured to pass through in its orthogonal body/foot orientation slightly smaller than that of the system 210. Guide hole in one of the bones.

It should also be noted that the pattern of the unit 20 in the spring member 120 can extend almost to the pivot pin 28 of the anchoring foot. This can be beneficial to maximize the active length of the device (for example, in the example provided, the system 220 includes 5 more spring component units 20 than the system 210). For a given axial displacement required by the device, a longer movable length (or in other words, a larger number of the same unit in a given length) will reduce the strain in each unit to further improve The possibility of fatigue life.

For construction, the material layer 10 of the spring component layer in the system 220 is defined by bending and thermosetting (for example, at about 500 degrees Celsius in a furnace for about 5 minutes or less in a salt bath) in a folded form to define a A stapes at 122 is folded to receive a pivot pin for foot attachment. The stapes can be in a simple "U" shape. However, in order to capture the pin 28, a "C" or "bulb" shape display is desired.

In the embodiment 220, two parts or parts (1, 2) are folded to form four layers 10 in the spring component section 120. Alternatively, one folded part may be used to provide two-layer spring parts, or three folded parts may be used to provide six-layer spring parts, and so on.

Each of the pinning foot embodiments of FIG. 2B and FIG. 2C facilitates its stable connection and easy precision manufacturing. After being so connected or attached, the anchor foot 60 can be rotated from a position aligned with the spring member body 110/120 to be transverse to the spring member body (or at least generally upwards of about 45 degrees or about 60 degrees up to 90 degrees. Corner) to anchor the overall device (usually its distal end) during a medical procedure.

Complex features can also be provided (for example, a component that is biased toward one of the lateral positions provided by an integral or complementary coil spring to facilitate the transition from the axial delivery configuration of the foot to its implanted position). Alternatively, one or more pull wires or pull cords may be used to accomplish or facilitate this rotation. U.S. Patent Application No. 16/728,851 filed on December 27, 2019 named "Bone and Joint Stabilization Device Features and Delivery Systems" presents other deployment system options applicable to this document.

Conversely, the multilayer spring component assembly described herein can be used in the system shown and described in the 16/728,851 application. Examples of these systems include devices with bone nails at the tip and various needle configurations. Regardless of these details, the construction techniques described in this application and other patents and patent applications incorporated herein by reference (such as laser cutting a specific flat pattern (such as shown in FIGS. 12A to 12C) ) Or injection molded similar parts) and material selection (e.g. nickel-titanium alloy or β-titanium alloy for the body layer of the spring component, polyether ether ketone (PEEK) or polyether ether for anchoring the head and/or foot Amine (PEI) polymer materials, stainless steel used for horizontal pins, etc.) can also be used in the embodiments of the present invention. Anchor head or button embodiment

In the anchor head embodiment 30 shown in FIGS. 3A to 4B, a body or base 31 of the anchor head may be made of PEEK or another biocompatible polymer. It can be processed, molded or 3D printed by fuse manufacturing (FFF) or selective laser sintering (SLS) or other methods. The polymer may be loaded with a radiopaque material, such as radiopaque barium sulfate.

Alternatively, the body or base 31 may be made of titanium, titanium alloy, or stainless steel to be completely radiopaque. To this end, parts or parts can be 3D printed by SLS. This can be expected from the point of view of providing the complexity of selection (for example, including the detent feature as described below), especially in view of the small size of the part and its features.

The tooth 40 used to capture or hold the spring component in the anchor head body or the base 31 may be made of metal. This tooth provides strength and radiopacity when made of stainless steel or Nitinol. Nitinol teeth can help limit the possibility of bimetallic corrosion with Nitinol spring components. In addition, this can make the design more flexible to include the detent feature by allowing greater deflection of the incorporated component.

3A and 3B show the anchoring head body or base 31 before the teeth 40 are crossed and the spring members 100/110/120 are inserted therein. The tooth part (which can alternatively be referred to as a (flattened) cross pin or transverse member) includes a spanning portion or section 42 and a optional hook or nub 44 carried on a flexible arm or rod 46. The deflection latch is capable of deflecting inward (for example, horizontally or left and right with respect to the bottom or bottom side "U" of the body 31) when the tooth is inserted into one of the transverse channels, rails or tunnels 32 defined and the body 31. When the tooth extension section 48 abuts the stop section 33 in the body 31, the small piece 44 is locked in the complementary socket, cavity or groove 34, as shown in FIG. 4B.

FIG. 4A shows the first stage of this insertion, in which the spring member body 100/110/120 is received through one of the lateral gap holes or feed openings or apertures 35 in the anchor head body or base 31. 4B is a cross-sectional view taken along the midplane of the transverse channel 32 and depicts the fully inserted or locked position of the tooth 40 relative to the anchor head and a multilayer spring member 100/110/120. After being positioned in this way, the layers of the spring member body and the tooth portions 42 of the windows 22 (the connector portion or section 16 seen in the cross-sectional view) in the engaging or capturing unit 20 passing through the multiple layers are firmly held together. .

Before use, the teeth are advantageously carried by or incorporated in the anchoring head. In other words, it is optionally received within the anchoring head so that it cannot withdraw or otherwise accidentally separate from the anchoring head before the teeth are advanced or deployed to traverse and hold the layer of spring components. To this end, the groove 36 serves as a detent feature. These receive hooks or nuggets 44 to allow them to be released when the teeth are fully pushed into the anchoring head. The channel or groove in the track 32 can be formed by drilling (or molding) the part shown in FIG. 4A with a cross hole 37.

Other anchor head bases and tooth configurations (and their incorporation of stops and detent features) are also feasible. For example, the flat surface of the tooth may include one or more bumps that interface with the hole 37 for catching and releasing. The teeth may include first and second (e.g., holding and locking positions) bumps for this purpose. Alternatively, an additional detent hole may be included in the body or base 31 for a single bump on the tooth surface or even on its side(s). Another option is to form a hole in the tooth and set a ball (for example made of PEEK or another plastic, elastomer or stainless steel) in the hole to complete the hole interface with one or more of the pedestals. .

In conjunction with the configuration of the anchoring head 30' shown in FIG. 5A and FIG. 5B, another method of detent is shown. Here, a slidable tooth or cross pin 40 includes a deflectable latch in the form of one (several) flexible tangs 46', which can be opposed to the flat bottom side U of the anchoring head when passing through the channel 32 Move up and down. The end 44' of each tang will lock when received in a recess or slot 34' formed in the anchor head body. Regarding the detent feature, it is provided by the interaction between the tang 46' and the cavity or cavity 36' machined or molded from above (e.g., shown in conjunction with the slot 37').

In addition to the advantages of incorporating (several) optional detent features, an important aspect of the anchor head design involves sliding its teeth into the base. This configuration enables the end of the tooth to pass completely through and through multiple layers in the spring member. After being positioned in this way, all the spring component layers 10 are directly supported or held by the spanning portion 42 of the tooth.

Although it is important that the spanning portion 42 supports or maintains each of the spring member layer 10, it is also important that the spanning portion of the tooth spans or spans the spring member feed opening or aperture 35. This configuration provides support on each side of the tooth to provide interface strength. An optional chamfer or introduction feature 39 (shown in dashed lines in FIG. 5B) that can be machined or molded into the body or base 31 for receiving the spring component is also useful. These features can be in the form of bevels (as indicated in Figures 5B and 6B), or they can be curved or cup-shaped features (as shown in Figure 8).

In any case, FIG. 6A is a perspective view of one of the upper or outer body parts or parts 31A of one of the exemplary embodiments of another anchoring head. FIG. 6B is a perspective view of the lower or inner body portion 31B of one of the exemplary embodiments of the another anchoring head. When connected, they form an anchoring head 30" and a body 31", as shown in each of FIGS. 11B and 12B (cross-sectional views).

This connection or attachment can be formed by an interference fit between the studs, posts or pins 50 in the socket or recess 51 (or through hole) in the portion 31B. Or the pin may be carried by the body 31B and the socket or through hole is formed in the portion 31A. Either way, the pin may be round, hexagonal or D-shaped (as shown in the figure) to include a flat portion that allows air to be distributed from the socket (shown in the figure) during a press-fit procedure.

The body part or portion 31A includes a spring member inlet or aperture 35 and a slot 32' that defines a closed channel when the body parts 31A and 31B are held together. The body part or part 31B also includes a feed port 35 aligned with the feed port of its complementary part. In addition, the body 31B includes one or more recesses or grooves 52 for receiving the deflectable latch portion of the tooth to be used.

Each of the cavities can be used for a purpose equivalent to 34/34' and 36/36' in the previous embodiment. The symmetrical shape and/or placement of the cavity 52 may facilitate assembly (so that the part is not oriented with respect to the slot 32).

In another optional aspect, either (or both) of the parts 31A and 31B may include a side cut area 54 to produce a convex portion 55 for defining the parts used when the parts are assembled (ie, held together) The anchoring head is kept separate from a base with opposed side slots 58 (as shown in Figures 11B and 12B). A beveled section 56 may also be included to facilitate removal of the anchor loader.

The base or bottom side (U) of the portion 31B may include one or more spring component introduction sections 39. These can be the chamfered surfaces described above for the anchor head(s) or can be shaped as a set of concave or cup-shaped surfaces, like the anchor head 30' shown in FIG.

To facilitate the handling and use of the anchor head (as described further below), an anchor loader and pin/tooth pusher device may be desired. Figures 7A and 7B detail this device. It is modified by adding a pin pusher lever arm or beam shown in Figures 9A to 11D of U.S. Patent Application No. 16/728,851.

More specifically, a plunger type loader or loading tool 70 includes a tunnel or through hole or inner hole 72 to allow a spring member body to pass through. It also includes a plurality of flexible extensions or "fingers" 74 with overhanging catching portions or tips ("nails") 76. An undercut bevel section 78 of each tip allows the anchor to be released as appropriate by pulling the loader away from the anchor after setting the anchor position and locking the anchor. The fingers are narrow and thin enough to allow for the flexure required for this movement. The figure shows eight independent fingers, but as few as three (usually symmetrically arranged) can be used advantageously.

The handle or body portion 80 of the plunger can be box-shaped or configured in other ways (for example, rounded or rounded). A lever arm 82 is connected to the body. It is capable of flexing toward the body 80 and includes a reduced width and/or rounded tip 84 that is configured to be pushed by the surface 86 to be received by a tooth in an anchoring head. The connection 90 between the body 80 and the lever arm 82 may be configured to act as a so-called living hinge. The insertion grip or positioning location 92 may be included in each feature.

Additional optional features are depicted in the anchor loader embodiment 70' (retaining anchor 30') shown in FIG. 8 and the cross-sectional views of FIGS. 9A and 9B (without anchoring head) are further detailed. Figure 10 shows a cross section of the same system in which a spring member body 100/110/120 is received in an anchor 30' held by an anchor loader 70'.

Regarding the features of the present invention, the lever arm 82 includes a notch or groove 88 formed to stably traverse the tooth 40' during insertion. The groove may be straight or rounded to match the curvature of the end(s) 48 of the tooth (which itself is so configured to match the curvature of the anchor body 31/31'). In addition, the loader embodiment 70' is configured to provide index operations in conjunction with the spring member body received therein.

This action is combined with the movement feature to complete. In an exemplary embodiment, each of the inserts 130 and 130' includes an inward guide protrusion 132 that interacts with the side or end connector 16 of the spring member body received in the loader. Figure 10 shows this relationship between the components.

Here, a "V"-shaped protrusion 132 is provided. When the body 100/110/120 is pushed or pulled through the anchor loader 70', these are seated or nested between adjacent units 20. The angle of V, the size of any radius or flat portion at the peak of V, and the length of the inserts 130 and 130' (and therefore the depth of the protrusions) can be configured so that a positive engagement is felt (for example, a tactile response is felt) . In this embodiment, the protrusion 132 acts as a detent feature, and a response is felt when the spring member flexes, because one unit 20 of the body 100/110/120 passes through a protrusion 132 so that the protrusion 132 rests on the adjacent unit 20 In a stable equilibrium position in the gap between. In this configuration or configuration, the spacing between the detent feature and the anchor received in the loader is such that when in this position, the anchor’s crossing teeth or pin 40' and one of the spring members ready for successful deployment. "Window" 22 is aligned.

Therefore, the convenience of this feature is noteworthy. In the solution, two (or more) control features are also selected. However, it can work with one plug-in and therefore a single plug-in.

In addition, the orientation of the detent feature (or "detent" for short) can be changed. For example, it (or the like (if plural)) can be set in a vertical plane relative to the described plane, so that the spring member interacts with its surface and window 22 rather than along its sides, as shown in FIG. 10 Portray. In this case, the insert(s) can advantageously be flexible (for example, using Nitinol "cards"), because entering and exiting the window involves bordering with a right-angled edge (and the spring member can be rounded, as shown in the figure) As shown, it naturally makes the spring member easy to transform or translate relative to the detent feature).

Regarding the configuration of the plug-in(s) that define the displayed detent feature, one of the bases 134 in one of the corresponding sockets 136 produced in the loader body can be elliptical to guide the V-shaped extension 132 The orientation. Otherwise, the plug-in base can be cylindrical and oriented in other ways (for example, by an indicator slotted or rotated like a screw-head plug).

In this embodiment, the device relies on the flexibility of the spring member (and the clearance of the inner hole 72 in the body 80 that allows flexure) to provide a spring action against the detent feature. Therefore, in the embodiment, the loader 70' does not include a discrete spring component on which the plug-in 134 is installed or built, which originally allowed sliding movement back and forth as the unit 20 moves through 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 to move back and forth. In other words, the catch itself can be loaded by the spring. In addition, the shape of the latch can vary with the material it is made of. You can choose stainless steel, NiTi, PEEK or another material.

The so-called fingers 74 and 74' are combined to show a difference between the embodiments 70 and 70'. In the loader 70', the fingers 74' and the cross pins or teeth 40' opposite to the downward pushing of the rod 82 are connected together. In other words, embodiment 70' provides a partial cup 74' that can include an overhanging catching edge 76' (as shown in the figure).

The body and/or insert of the anchor loader can be injection molded or processed for manufacturing. The body of the anchor loader may include a textured surface or additional features for the user to grasp during handling. Preparing the device for use (ie, inserting an anchor into the loader) can be done manually by a user or it can be done in advance, so that the anchor and the loader or plunger are provided in a "set" manner.

Returning to FIGS. 6A and 6B, the anchor loader (whether it includes the described detent feature or not) may include an optional (as indicated by the dashed line) meter or counter 96. It can use a damper or a spur gear mechanism inside the body 80 that is interfaced with the window or aperture 22 of the body through which the feed passes. In use, advance the end of the loader until the anchor touches the bone or a plate with which it will be used. Then, 1) an optional button 98 can be pressed to engage the damper or spur gear with the body, or 2) the button can be pressed to reset the meter or counter 96 to zero.

As a counter, it can indicate the number of units that are pulled to tighten the body (by counting windows or apertures). As a gauge, it can display an estimate of the tension or compression force. This can be used in the context of selecting the loader (or the overall system) for the expected length of movement of one of the spring components between the anchors-it can be under X-ray or using a calibration C-clamp or a custom measurement tool. Determine one of the items.

Indicating value reading can use analog counting wheel, an analog scale or a digital counter or display. In addition, although simple mechanical methods (such as a damper or spur gear) for interfacing with the main body 100/110/120 to count units or estimate tension have been disclosed, electrical (analog or digital) methods can be used instead.

FIG. 11A is a perspective view of an anchor loader embodiment 140 that includes movable (ie, spring loaded) detent features and a locking collar 150. FIG. Figure 11B is a bottom cross-sectional view of the anchor loader of Figure 11A, in which an anchor head 30" and a part of a spring member 100/110/120 are added. As seen in each view, a tooth or a detent is added. The claw 132 is provided (e.g., integrally formed) at the end of a lever arm 142 extending in a cantilever manner from a contact surface 144 with the remaining part of the anchor loader body 80. Embodiments of the present invention may include two such switches The moving feature (as shown in the figure) may be a one-sided design.

Regarding its action, it is desirable to insert each pawl so that tactile feedback is generated when the spring member is passed through the pawl. For example, when the loader is produced in nylon, PEEK, or another engineering plastic, a 0.003 inch insertion (interference) can be expected. After being so configured, it undergoes inward and outward movement (and associated tactile resistance), as indicated by the double-headed arrow shown in Figure 11B.

Regardless of whether this method is selected, the lever arm(s) includes pushing a bulge or slope 146 inward after the propelling sleeve 150 faces and (as the case may be) in contact with a stop area 152 of the body 80 through the pawl 132. In this position, the anchor tooth 40' is aligned with one of the openings 22 of the spring member body for deployment therethrough.

From an ergonomic point of view, a gripping feature 154 can be provided along the sleeve. The clamping feature 156 can keep the sleeve on the body 80. For assembly, the parts can only be snap-fitted in place.

For manufacturing, the body 80 can be provided as a single part, especially when it will be constructed using SLS or another layered manufacturing method. For production by processing or injection molding, the body can be produced into two or more parts that can be press-fitted or snap-fitted together or fixed with fasteners (for example, relative to the loader 140 described below) 'Described). The dashed separation or dividing line indicates how the sub-assembly parts of the body can be configured (partially) and finally fit together. This is an option.

FIG. 11C details a configuration of the anchor loader 140 body including separate body parts 80A and 80B. This method is designed to be produced by machining or injection molding. A press fit between the pin 50 and the socket 51 is used to assemble the parts as indicated (by arrows). The stability of the fit between the parts 80A and 80B is also assisted by the interface between a handle 158 and the channel 159.

Another noteworthy feature is the shape of the socket. They can be non-symmetrical in design to provide a ring-shaped close-fitting (positioning) pin/socket combination and three pins received in the slotted socket for process differences. As shown in the figure, the major axes of these slots are all oriented toward the positioning pin/hole combination to minimize over-constrained fit.

After assembling, the main body of the device has exactly the configuration shown in FIG. 11A (if you ignore the demolding angle shown in various ways in FIG. 11C, it can actually be ignored when the two-part body method is set for processing). However, the configuration of the so-called fingers and tips used to hold the implant anchor can be different (as shown when comparing components in Figures 11A and 11C). Not only is a so-called "cup" part omitted from the part in FIG. 11C, it also increases the volume of the finger 74' relative to the finger 74 (resulting in higher stiffness) and reduces the bevel angle relative to the bevel angle 78 78' facilitates anchor retention with lower fingers during propulsion by the teeth/cross pins while still allowing anchor release (although a slightly higher release force is used when pulling the loader away from the anchor after deployment). When designing for manufacturability, eliminating the cup can reduce molding and/or processing challenges.

Regardless of the details of the configuration, in use, a physician can tighten the spring member body 100/110/120 between a previously installed anchor, and set the anchor 30" and/or the tip 76 of the loader device 140 to abut Depending on the subject's body structure or applied to one of its orthopedic plates. With the tension in the system, the loop 150 can be translated previously to thereby lock the pawl(s) 132 and the side(s) of the spring member at its end Connect 16. After being locked in this way, the physician can physically check the tension of the device and/or radiographically confirm that the body structure between the anchors of the system needs to be reduced. If under tension, the sleeve or collar 150 can return to its original position, the spring member is further tightened and locked again. After the physician is satisfied, the lever arm 82 is actuated by a thumb positioned against the grip 94 to pass the slidable tooth 40' through the multilayer spring member The opening 22 of each unit 20 in the construction 100/110/120 is deployed across the anchor body 32". Finally, repair the body of the excessive spring component.

Similar operations can be performed in conjunction with the anchor loader 140' shown in FIGS. 12A and 12B. However, this system includes gears that mesh with spring components. Although not shown, it can also be incorporated into a lock.

However, with regard to the general method of using the gear 160, it has an advantage of rolling with the spring member in constant positive engagement on the side connectors 16 and between the units 20 between the side connectors 16. (Several) The meshing between the gear and the spring member can be smooth or adjusted by the detent feature. In one example, the pawl includes a pawl 132 positioned at the end of a flexible lever arm 142', which is very similar to the previous embodiment except that the pawl interacts with the teeth 162 of the spur gear(s) The claws. In another method, the socket or cavity 164 can be machined in the surface of the gear(s). These can interact with the ball detent feature carried by the device body feature (not shown in the figure) or incorporated into the device body feature. In either case, the detent feature(s) can be spaced from the gear(s) to align with any of the windows 22 in the spring member body 100/110/120 for the anchor tooth 40' to receive.

Other optional construction details include a two-piece body construction with body halves 80A' and 80B', as shown in FIG. 12A. These halves can be fixed to each other via pressure pins or screws received in the holes 148. This structure can be produced by machining or molding. However, this embodiment 140' and the other embodiments described above can be produced using so-called rapid prototyping or 3D printing technology (which includes SLS, SLA, or FFF). In fact, the operable device has been produced in this way by the assignee of the present invention.

Another selection detail concerns the way the gears are fixed in the device. In one method, a gear axis 166 may be received in a socket lug 170 connected to a gear housing 172 by the flexible arm 174. This configuration allows the gear(s) to be snapped directly into place instead of being inserted and then pinned (through press-fitting as appropriate) into place.

It is also worth noting that the distal end of the loader may include "fingers" 74 having "nails" 76 extending beyond the optional side slot in an anchoring head. These can be configured as shown in the figure to engage the opposed middle slot 58 in the anchor body 31". Alternatively, these features can be configured as in the previous embodiment.

Regardless of the configuration, the loader 70 (or the loader 70', 140 or 140') can be pre-assembled or loaded with an anchor 30 (or 30' or 30") and packaged or set according to one of the packages depicted in FIG. 13 300 is provided in a thermoformed tray 310 (which will usually be sealed by a TYVEK or another cover (not shown)). The overall treatment system will also include a spring component 100 (or another such component 110 or 120). As discussed above, the spring member can be connected to a Beath needle 320 (or other introducer or guide). As shown in the figure, the use of receiving and holding (for example, by swaging) in a proximal end 322 of the needle The polymer suture material 330 is used to attach (through the lug 24 and the eyelet 26) the needle. Medical method

In order to reduce an injury (such as a fracture or sprain) to a body position, one or more of the device embodiments of the present invention are installed through (several) incisions and (several) pre-drilled holes. When the device is applied or installed in this way, tension can be achieved because the body structure rebounds slightly after it is manually compressed or reduced using a splint. Alternatively, the device can be tightened as shown in Figure 14. During this time, a cable tie tool or a modified version of the so-called "cable tie gun" can be used to automatically or semi-automatically tighten and/or trim The spring component body after tensioning. This instrument can include a spring-based dynamometer or one of its digital dynamometers (additional details of the latter will be provided below) and an analog or digital indicator or light display (e.g. a green/yellow/red LED) To prompt a user according to the following method.

With specific reference to the actions or steps in the method 400 shown in FIG. 14, an optional calibration step may occur in 410. This can be performed by a user who intends to implement the tightening method of the device or system of the present invention during manufacturing.

More likely, after setting the distal anchor position in 420 (if it is tied to an anchoring head or foot, (for example) in the middle of a syndesmosis repair procedure), set the proximal anchor position (for example, in a syndesmosis). Lateral in the program). Then, in 430, the spring member is engaged or grasped (directly engaged or grasped by a surgeon or using forceps or a special tensioning instrument). Alternatively, the order of these operations can be reversed.

Either way, the spring member body is pulled or retracted in 440. This provides or allows testing of the tension on or applied to the spring member in 450. This test can be a relative or tactile test by one of the surgeons, but it is preferably a test quantified by digital or analog hardware discussed in various ways.

If the tension is not as expected, adjustment is made in 460 by drawing or releasing the length of the spring member relative to the anchor head. Regardless of whether the optional step 460 occurs, the anchoring head parts are locked together in 470 (for example, using one of the sliding teeth and the detent structure described above).

Regardless of how the preload application may be accomplished, the excess spring component length is then trimmed (for example, using a flat cutter or a cutting pliers integrated in a tensioning device) so that the remaining structure is flush with the anchoring head. After such preparation, the device of the present invention remains active to provide continuous compression that allows the body structure to move across a joint or to provide a pressureless replacement of a fracture, a rigid nail, or a rigid nail. Finally, as mentioned above, with respect to FIGS. 8 to 15 of US Patent No. 10,194,946, the description is also applicable to the suitable method of medical use of the embodiment of the present invention. Experimental result

The following will present the cyclic fatigue test and modeling results of many spring components and spring component components. The spring parts are all laser cut from super-elastic nickel-titanium alloy plates with the same flat or platform shape or pattern (each using fiber laser technology) and about 0.001 inches of material is removed on each side for electro-polishing. Therefore, the material thickness (and any associated bulk material properties) in device production is considered an important variable in the comparison of cyclic fatigue life. In other words, try to provide a set of true comparisons of the test device performance and make the associated performance estimates below. Test conditions A to D

The report in Table 1 is for samples classified according to test condition types (test conditions) A to D and takes into account the sample type, the total thickness of the sample in inches (in) and millimeters (mm), in Newtons (N) and grams (g) ) Or kilogram (kg) force is applied to the approximate preload (preload) of (several) samples, the axial displacement (axial displacement/unit) of each unit 20 applied to (several) samples in mm, the achieved The number of cycles (under the mentioned conditions) and a first set of tests that provide additional background and associated annotations. The sample of the test condition A is a single-layer configuration as depicted in Figure 1A, but has a beam thickness (T) and width (W) with an aspect ratio of about 5:1, as mentioned in Table 1 below Thickness dimension. The single construction layer of test condition B also has the single layer configuration of FIG. 1A, with the thickness dimensions mentioned in Table 1 and the 1:1 aspect ratio actually shown in the figure. The five-layer construction samples of test condition C and test condition D are in the configuration of Fig. 1B (without additional layers 102, 104, 106), and each of the five layers has a 1:1 aspect ratio and the sum of the five layers or Add up the total thickness of the dimensions in Table 1 (see T _{t in} Figure 1B). The samples tested are as follows: Test Conditions Sample type Total thickness Preload Axial displacement/unit Number of cycles Annotation A All-in-one 0.039 in 1.0 mm 10 N 1.0 kg 0.028 mm 17,100 (Sample 1) 18,000 (Sample 2) Sample run failure B Single building layer 0.008 in 0.2 mm 2 N 215 g 0.028 mm 1,665,000 (no failure) 1 mm construction of 1/5 thickness (hence scaling preload) C 5-layer construction 0.039 in 1.0 mm 10 N 1.0 kg 0.028 mm 57,000 (1 layer failure) 1,728,000 (4 no failure) According to the layers of the 0.008 in/0.2 mm construction (same as test B) D 0.042 mm 36,500 (second and third failure) 44,700 (fourth layer failure) 85,000 (fifth layer failure) Apply +45% axial displacement as one of the 4 survival layers of test condition C to challenge the test Table 1

Many observations are drawn from the test data outlined above. Most unexpectedly, a five-fold (5x) reduction in the thickness of the device layer can produce up to 100x (or greater) improvement in fatigue life. This can be seen in the comparison of test conditions A and B (when the test is terminated before the device fails, test condition B reaches 95x the average number of cycles of test condition A (ie, 17,550)). Because the test condition B was terminated before the device failed, it could have exceeded this comparison value. Similarly, when the test condition C is suspended, 4 out of the 5 layers of the sample in the test condition C reach the 98x average cycle of the test condition A. After performing the challenge test under test condition D, 100x cycles are reached before any more layers in the layered construction fail. It is worth noting that the final failure of the additional layer under test condition D occurred under significantly more stringent testing. If the initial 0.028 mm/unit cycle continues under test condition C, it is reasonable to believe that the cycle life of the test item will further exceed 100x of the fatigue life of the integrated design (in view of the termination of the test before the spring component breaks, the reported result is The so-called "jitter" value). In any case, the observed improvement in fatigue life seen in test conditions B to D shows a two-order improvement relative to the results of test condition A. In other words, samples designed to be different from each other only unexpectedly cause thinner samples to be able to achieve beating under the applied test conditions only in thickness.

Regarding this consistency and the possibility of earlier failure of a given single-layer sample (for example, as in test condition C), it is very important to note that this rupture in a multi-layer construction does not significantly degrade the overall device function. important. This is especially true for the anchoring head described in this article, which even continues to hold the fractured layer part. The only expected result is a small proportional drop in one of the available compressive forces. Length dependent test

Perform further testing on samples configured as above. In this test, a single "one-piece" (ie, 1 mm thick) spring component and a single 0.2 mm device "layer" are tested. A sample with 2.5 lbf applied preload is tested by the length across the list range; a single layer sample with 1/6 of the 2.5 lbf applied preload is tested by the length across the list range (since it is intended for clinical use as described in this article) One of the six-layer construction).

Table 2 presents the estimated fatigue life of a representative intermediate (ie, 50th percentile) device generated by fitting a regression analysis of data generated for a sample size of one of the nine integrated design samples. In the table, the black body value across the top indicates the total applied displacement in mm, and the black body value along the left indicates the length of the device subjected to this displacement. The value in the table (ie, the expected number of cycles before failure) follows a predictable decrease in one of the fatigue life heights in the original data associated with the applied displacement relative to the increase in the length of the device. 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 40 145,000 53,825 26,700 15,525 9,980 6,868 4,960 3,730 2,885 2,290 1,850 45 191,889 71,700 35,578 20,722 13,300 9,136 6,610 4,960 3,846 3,047 2,470 50 247,000 92,300 45,900 26,700 17,200 11,800 8,530 6,410 4,960 3,940 3,190 55 247,000 117,000 57,973 33,709 21,682 14,900 10,745 8,085 6,260 4,960 4,022 60 247,000 145,000 71,700 41,650 26,700 18,367 13,300 9,980 7,733 6,135 4,960 65 247,000 176,077 87,146 50,592 32,454 22,362 16,123 12,146 9,388 7,451 6,032 Table 2

A slightly larger sample size (ie, samples with ten device layers) was used to generate Table 3 in the same manner as in Table 2 (ie, the 50th percentile device estimate is also displayed based on test data). Again, the black body value across the top of the table indicates the total applied displacement in mm, and the black body value along the left side indicates the length of the device subjected to this displacement. A trend similar to the trend presented in Table 2 was observed, but with a layer with more than 1,000,000 (1 M) cycles in a multi-layer design under the specified list conditions, which significantly improved fatigue performance. 0.50 0.75 1.00 1.25 1.50 1.75 2.00 2.25 2.50 2.75 3.00 40 ＞1M ＞1M 435,000 148,500 61,250 29,025 15,200 8,580 5,150 3,248 2,130 45 ＞1M ＞1M 773,333 261,889 108,067 51,256 26,911 15,200 9,116 5,741 3,763 50 ＞1M ＞1M ＞1M 435,000 180,000 85,300 44,700 25,300 15,200 9,560 6,270 55 ＞1M ＞1M ＞1M 694,545 286,636 136,000 71,055 40,064 24,118 15,200 9,942 60 ＞1M ＞1M ＞1M ＞1M 435,000 206,667 108,067 61,250 36,733 23,133 15,200 65 ＞1M ＞1M ＞1M ＞1M 642,615 304,615 160,000 90,262 54,162 34,131 22,362 table 3

In addition, the results in both of these tables are generally consistent with the results in Table 1. (For comparison between tables, the approximate displacement of each unit in each design for any given entry in Tables 2 and 3 can be obtained by dividing the length of a selected device by the applied displacement (because each unit is approximately 1 mm long )).

In addition, it should be noted that the estimates in Tables 2 and 3 indicate when a single device layer can be expected to fail. In other words, this performance does not take into account that one or more of the layers can fail while the overall device maintains the redundancy of a complete multi-layer design.

In addition, it can also be observed from Table 2 and Table 3 that the fatigue life of the sample decreases with the applied displacement per unit length of the device. However, various design parameters of the spring member pattern (ie, the cutting pattern used to generate the cutting pattern in the device of the present invention) can be modified to improve this effect of the shorter implant device. Specifically, FIGS. 15A to 15C illustrate the methods that can be applied to increase the unit count per unit length of the device (thus reducing the axial displacement per unit of a given device length) without introducing other bad performance changes. The configuration of the spring component changes.

Figure 15A shows a length of a spring member pattern A. Pattern A corresponds to the pattern shown in the figure and used in the test mentioned above. The difference between pattern B and pattern A in FIG. 15B is that it reduces the length of the bridge 18 (L _br ) and the width of the aperture or window 22 (W _w ). The pattern C in FIG. 15C incorporates the change of the pattern B and is also inserted into the bridge 18 position relative to the outer connector 16 (resulting in the shape of the bent rod or beam assembly 14 or the "bulb"-shaped unit end). On the equivalent length of one of the 12 units in the pattern A shown in FIG. 15A, the pattern B gains 3 units to a total of 15 units; on the same relative length, the pattern C gains 4 units to a total of 16 units. Therefore, the use of pattern C in a spring member will result in one device per unit displacement that is the same as that of a 60 mm device using pattern A, depending on the length of 45 mm.

Another method that can be used to reduce the strain per unit cell over a given positioning and movable length of one of the spring members is to reduce the width of the bridge 18 (W _br ). When a spring component body of the same width is compared with another spring component body without change, this increases the relative length of the rod or beam 14 to provide the possibility of the same axial deflection with reduced peak stress and strain. Alternatively (or in addition), the overall pattern width can be increased to adopt longer beams 14. However, this requires a longer guide hole. Therefore, it should be understood that the selected design involves many competitive variables.

Naturally, a further change in the pattern of the spring member can be applied to further improve the cyclic fatigue life with a shorter device length. Of course, in addition to the volume change described, shape refinement guided by finite element analysis (FEA) is also feasible. In any case, for the multilayer device of the present invention, it may be desirable to participate in the pattern design or selection so that any length of the implant to be used to describe the design is subjected to less than about 0.025 mm to about 0.030 mm per unit or more specifically, each The axial displacement of the unit is less than 0.027 mm or 0.028 mm. In addition, these equivalent values vary with different unit configurations, as considered within the scope of the present invention and its embodiments. Digital hardware

Commercially available electronic hardware can be used to obtain the tension or the associated compression force measurement in the method of the present invention. Strain gauges and piezoelectric sensors for measuring the compression and/or tension between parts of a sensor substrate or interface are well known. These can be used in this article.

If so, a general-purpose or special-purpose processor or processing circuit system, a digital signal processor (DSP), a special-purpose integrated circuit (ASIC), a programmable circuit system designed to perform the functions described herein can be used A gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof implements or executes calculations or procedures implemented in conjunction with the embodiments herein. A general-purpose processor may be a microprocessor, but alternatively, the processor may be any conventional processor, controller, microcontroller, or state machine. The processor can be part of a computer system. The computer system also has a user interface port that communicates with a user interface and receives commands typed in by a user, and has the ability to store electronic information (which includes operations under the control of the processor). At least one non-transitory memory (such as a hard disk or other equivalent storage and random access memory) and through any kind of video output format (such as VGA, DVI, HDMI, USBC, display port or any other form) to produce one of its output video output.

A processor can also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or multiple microprocessors in combination with a DSP core, or any other such configuration. These devices can also be used to select the values of the devices described herein.

The steps of the method described in this text executed by an electronic device can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the function can be encoded as instructions and data in a non-transitory computer-readable medium (such as a computer memory). When executed by a processor, the encoded instruction can cause a device (such as a flow sensor) to perform one of the methods described herein. Computer-readable media includes both computer storage media and communication media, and includes any media that facilitates the transfer of a computer program from one place to another. A non-transitory computer-readable medium can include any non-transitory medium suitable for being accessed and decoded by a computer. For example (but not limited to), this non-transitory computer readable medium may include RAM, ROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices or may be used for encoding to be non-transitory Any other media in the form of sexual commands or data structures that can be accessed by a computer. The memory storage can also be a rotating magnetic hard disk drive, an optical disk drive or a storage drive based on flash memory or other such solid, magnetic or optical storage devices. In addition, any connection is properly termed a computer-readable medium.

The operations described in this article can be implemented on or through a website. The website can be operated on a server computer or locally (for example by downloading to a client computer) or via a server farm. The website can be accessed through a mobile phone or a PDA or on any other client. The website can use HTML codes in any form (such as MHTML or XML) and through any form (such as cascading style sheets ("CSS") or others). change

Hereinafter, various aspects of the present invention will be described to review and/or supplement the embodiments described so far, and focus on the mutual relationship and interchangeability of the following embodiments. In other words, unless otherwise clearly stated or logically infeasible, the focus is on the fact that each feature of the embodiment can be combined with each other feature.

In many exemplary embodiments, a device is provided that includes: a spring member including a plurality of layers held together, wherein each layer of the plurality of layers has an elongated stretchable structure with two laterally extending outwards , And each layer of the plurality of layers includes a plurality of beams arranged in pairs, wherein a first beam and a second beam of each pair are connected to each other only at the two lateral extensions, so that the first beam and the The second beams are opposed to each other, and each pair of beams is connected to an adjacent pair of beams only by an intermediate connector, so that there is a gap at the two lateral extensions between each pair of beams and the adjacent pair of beams. The beams and connectors at the extensions of the beams can be formed into a shape selected from rectangular, square, race track, oval or circular shapes.

In any and all of these embodiments, the spring component layers (and the overall stacked construction) advantageously include an SE NiTi alloy.

In any and all of these exemplary embodiments, the spring component layers may be individual layers held together by at least one weld. Only one weld may be provided, and the weld may be located at one end of the spring member.

In any and all of these exemplary embodiments, each of the plurality of layers is about 0.01 inches (0.25 mm) thick, such as, for example, between 0.008 inches (0.20 mm) and 0.012 inches (0.30 mm) thick.

In any and all of these exemplary embodiments, the beams have a ratio of width to thickness between about 2:3 and about 3:2. The ratio can be about 1:1.

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

In any and all of these embodiments, the device may further include: an anchor foot including a first end, a second end, and a pivot hole between the first end and the second end; Longitudinal extension, which extends from the distal end of one of the beams of each layer, and one of the distal ends of each longitudinal extension includes a hole; and a pin formed by the anchoring foot pivot hole and each longitudinal extension The pore accepts.

In any and all of these embodiments, the device may further include: an anchor foot including a first end, a second end, and a pivot hole between the first end and the second end; A first spring component part, which is doubled around a fold to form two spring component layers; and a pin which is received by the anchor pin pivot holes and received in the spring component part Fold. The device may further include a second spring component part folded on the first spring component part. The device may further include a third spring component part folded on the second spring component.

In any and all of these embodiments, the device may further include an anchoring head. The anchoring head may have a body and a tooth slidably received in the body, wherein the tooth is configured to traverse the plurality of spring component layers. The body and the tooth can be configured to lock each other when the tooth is advanced to a locking position in the body. A deflectable latch can be provided for this. In one example, it is in the form of a flexible arm hook that can move left and right relative to a base of the anchoring head. In another example, the latch is in the form of a deflectable tang that can move up and down relative to a base of the anchoring head. In each case, the end of the latch will lock when received in a recess or slot formed in the anchor head body.

One or more of these anchors (depending on whether the spring member has a foot attached to it, as in some embodiments) are included as part of a system or set according to the package combination. The anchor(s) are preset or held in a loading device configured to releasably hold an anchor as appropriate. This device advantageously includes a lever arm capable of moving and deploying the sliding teeth or cross pins of the anchor before its release. It also advantageously includes a detent feature to facilitate use. Specifically, the inclusion of this (etc.) feature advantageously automatically aligns the anchor and the spring member body to deploy the sliding tooth or another crossing member.

For example, in any and all of these embodiments, the system may include at least one anchor loader for applying an anchor to the spring member, the loader including: a body that is configured to receive the A tunnel of the spring member; a plurality of flexible extensions, etc. from the body, each of the flexible extensions includes an overhanging tip configured to hold the anchor; and a lever arm connected to The body, the lever arm can move toward the body and includes a tip that is configured to push an anchor tooth of the anchor head to a final position. The anchor loader may further include at least one detent feature positioned to interact with the spring member to align any of the windows in the spring member body for anchor tooth reception. The at least one detent feature can be positioned to fit between adjacent connectors extending laterally outward along one of the spring members. The at least one actuation feature can be integrated with the oval base. The system can include two control features. The spring member, anchor loader, and the detent feature can be configured to operate without the detent feature being loaded by the spring. In any and all embodiments, the at least one detent feature may include a V-shaped extension.

In any and all of these embodiments, a method of tightening the medical device (or similar functional device) of the present invention may include: setting a position of a proximal anchor and a spring member received through the proximal anchor; pulling the spring member To test the tension of the spring member; adjust the tension of the spring member by pulling the extra length of the spring member through the proximal anchor or allowing the length of the spring member to retract through the proximal anchor; and lock the proximal anchor . In this method, a digital dynamometer can be used to test the tension of the spring component. Alternatively, the anchor(s) is applied to a spring member that is reduced (manually or using a splint) received in the body structure without this application of tension or preload.

When a range of values is provided, it should be understood that each intervention value between the upper limit and the lower limit of the range and any other designated or intervention values within the designated range are covered by the present invention. In addition, it is expected that any optional feature of the described invention variations can be described or claimed independently or in combination with any one or more of the features described herein. In addition, unless the scope of the patent application clearly includes limitations from the specification, these limitations are not intended to be interpreted into any claims.

As used herein and in the scope of the attached application, unless the content clearly indicates otherwise, the singular forms "one" and "the" include plural referents. In other words, the use of the article allows "at least one" of the subject matter in the scope of the patent application described above and below. Any optional components can be excluded from the scope of patent application. Therefore, this description is intended to serve as the basis for the use of exclusive terms (such as "only", "only" and the like) or the use of a "negative" restriction in conjunction with the description of the claim element.

Without using this exclusive term, regardless of whether a given number of elements are listed in the claim, the term "including" in the scope of the patent application will allow any additional elements to be included, or the addition of a feature can be regarded as changing the scope of the patent application The nature of one of the elements described in.

The open case discussed in this article is only for the disclosure content before the filing date of this application. Nothing in this article should be construed as an admission that the present invention has no right to precede this disclosure by prior disclosure. In addition, the publication date provided may be different from the actual publication date that may need to be independently confirmed.

In this way, sufficient details and clarity are used to carry out the subject matter described in this text and in the drawings to allow the inclusion of the requested item in a component-plus-function format at any time in accordance with 35 U.S.C. Chapter 112 Part (f). However, a claim is only interpreted as quoting this component plus function format when the phrase "component for..." is clearly stated in the claim.

Although the embodiments may accept various modifications and alternative formats, specific examples thereof have been shown in the drawings and described in detail herein. However, it should be understood that these embodiments are not limited to the specific forms disclosed, but on the contrary, these embodiments cover all modifications, equivalents, and substitutions that fall within the spirit of the present invention. In addition, any feature, function, action, step, or element of the embodiment may be described or added to the scope of the patent application, and features, functions, actions, steps, or elements that are not within the scope of the patent application define the negative of the category. limit.

1: part/part 2: part/part 10: spring part layer 12: beam/beam part 14: rod/beam 16: connector 18: bridge 20: unit 22: window/aperture/opening 24: lug 26: eyelet 28: Pin 30: Anchor Head/Anchor 30': Anchor Head/Anchor 30": Anchor Head/Anchor 31: Body/Base 31': Anchor Body 31": Anchor Body 31A: Part/Part 31B: Body Part/part 32: channel/track/tunnel/slot 33: stop section 34: socket/cavity/groove 34': cavity/slot 35: clearance hole/feeding port/pore 36: groove 36': pocket/cavity 37: hole 37': slot 39: lead-in feature/ lead-in section 40: tooth/pin 40': tooth/pin 42: part/section 44: hook/small piece 44': end 46: arm/rod 46': tang 48: overhanging section/end 50: pin 51: socket/recess 52: recess/groove 54: side cut area 55: convex part 56: beveled section 58: open Slot 60: Anchor Foot 62: Hub 64: Surface 70: Loader/Loading Tool 70': Anchor Loader 72: Inner Hole 74: Extension/Finger 74': Finger/Part Cup 76: Part/ Tip/nail 76': overhanging catch edge 78: bevel section/bevel angle 78': bevel angle 80: body part/part 80A: part/part 80A': half part 80B: part/part 80B': half part 82 : Lever arm 84: rounded tip 88: notch/groove 90: connector 92: insertion grip/positioning position 94: grip 96: meter/counter 98: optional button 100: spring component body/spring component construction 102: Extra layer 104: Extra layer 106: Extra layer 110: Spring component body 112: Extension 114: Eyelet 120: Spring component body 122: Fold 130: Insert 130': Insert 132: Base/Insert 134: Protrusion/Extension Part/tooth or pawl 136: socket 140: anchor loader 140': anchor loader 142: lever arm 142': lever arm 144: joint 146: bulge/bevel 148: hole 150: collar/sleeve 152 : Stop area 154: gripping feature 156: clamping feature 158: handle 159: channel 160: gear 162: tooth 164: socket/cavity 166: gear shaft 170: socket lug 172: gear housing 174: arm 200: Overall device or system or embodiment 210: Second device or system embodiment 220: Third device or system embodiment 300: Set 310: Tray 320: Needle 322: Proximal end 330: Suture material 400: Method 410: Step 420 : Step 430: Step 440: Step 450: Step 460: Step 470: Step L _br : Bridge length T _b : Thickness W _b : Width W _br : Bridge width W _w : Window width WB: Solder bead

The details of the subject set forth herein (with respect to both its structure and operation) can be understood by studying the drawings (in which the same component symbols may refer to the same parts). The components in the figure are not necessarily drawn to scale, but focus on explaining the principle of the subject. Draw a diagram to express the concept, in which the relative size, shape, and other detailed attributes can be schematically or accurately shown. Proportional characteristics (for example, from engineering drawings and/or photos) can be relied on as the basis for the preliminary support of the requested item.

FIG. 1A is a partial perspective view of an exemplary embodiment of a single spring component layer; FIG. 1B is a partial perspective view of an exemplary embodiment constructed using the multiple layers shown in FIG. 1A.

Figures 2A to 2C are side perspective views of an exemplary embodiment of a complete orthopedic implant or surgical system with the spring component layer shown in Figures 1A and 1B.

Fig. 3A is a perspective view of an exemplary embodiment of an anchor head (or attachment button) that can be used in the system of Figs. 2A to 2C or other related embodiments; Fig. 3B is the anchor shown in Fig. 3A A cross-sectional view of a body part of the fixed head.

Fig. 4A is a perspective view of the anchor head of Fig. 3A and a multilayer spring component received therein to prepare for anchoring or deployment of the anchor teeth; Fig. 4B is a cross-sectional view of one of the components in Fig. 4A, wherein The tooth is in its fixed or final position to fix the spring component.

Fig. 5A is a perspective view of another exemplary embodiment of an anchor head that can be used in the system of Figs. 2A to 2C; Fig. 5B is a cross-section of a body part of the anchor head shown in Fig. 5A picture.

Fig. 6A is a perspective view of an upper or outer body part of another exemplary embodiment of an anchor head; Fig. 6B is a perspective view of a lower or inner body part of another exemplary embodiment of an anchor head.

FIGS. 7A and 7B are different perspective views of an exemplary embodiment of an anchor loader for use in coordination with the anchor head detailed in FIGS. 3A to 3B and FIGS. 5A to 5B.

Figure 8 is a perspective view of another exemplary embodiment of an anchor loader and an anchor received therein.

9A and 9B are side cross-sectional views of the anchor loader shown in FIG. 8.

Fig. 10 is a bottom cross-sectional view of the anchor and anchor loader shown in Fig. 8 in which a spring member is added.

Figure 11A is a perspective view of an anchor loader embodiment including an active detent feature and a locking collar. Fig. 11B is a bottom cross-sectional view of one of the anchor loader of Fig. 11A in which an anchor head and a spring part are added. FIG. 11C is an assembly or construction diagram of one of the parts of the anchor loader embodiment of FIG. 11A configured to be processed or injection molded into two parts.

Fig. 12A is a perspective view of an embodiment of an anchor loader including a detent gear. Fig. 12B is a bottom cross-sectional view of one of the anchor loader of Fig. 12A in which the anchor head and the spring part are added.

FIG. 13 depicts an exemplary embodiment of an overall system having one of the components selected from the components shown in various ways in the above figures.

Figure 14 is a flow chart of an exemplary tightening method embodiment.

Figures 15 to 15C show different patterns of spring member embodiments that can be used herein.

10: Spring component layer

24: lugs

26: Eyelet

30: Anchor head/anchor

40: tooth/pin

100: Spring component body/spring component construction

200: Overall device or system or embodiment

WB: Solder bead

Claims (40)

A system including: A spring component that contains a plurality of layers held together, Wherein each layer of the plurality of layers has a long stretchable structure with two laterally extending outwards, Each of the plurality of layers includes a plurality of beams arranged in pairs; Wherein each pair of a first beam and a second beam is connected to each other only at the two laterally outer extensions, so that the first beam and the second beam are opposed to each other, and Each pair of beams is connected to an adjacent pair of beams only by an intermediate connector, so that there is a gap between the two lateral extensions between each pair of beams and the adjacent pair of beams. Such as the system of claim 1, wherein the plurality of layers are individual layers held together by at least one welding. As in the system of claim 2, both the proximal and distal ends of the spring member are welded. Such as the system of claim 1, wherein each of the plurality of layers is about 0.01 inches (0.25 mm) thick. Such as the system of claim 4, wherein each layer of the plurality of layers is between 0.008 inches (0.20 mm) and 0.012 inches (0.30 mm) thick. The system of claim 1, wherein the beams have a ratio of width to thickness between about 2:3 and about 3:2. Such as the system of claim 6, wherein the ratio is about 1:1. Such as the system of claim 1, wherein the plurality of layers includes at least 3 layers. Such as the system of claim 8, wherein the plurality of layers includes at least 4 layers. Such as the system of claim 9, wherein the plurality of layers includes at least 5 layers. Such as the system of claim 10, wherein the plurality of layers includes at least 6 layers. The system according to any one of claims 1 to 11, wherein the spring member includes a NiTi alloy which is superelastic at human body temperature. Such as the system of claim 1, which further includes: An anchor foot, which includes a first end, a second end, and a pivot hole between the first end and the second end; A longitudinal extension extending from the distal end of one of the beams of each layer, and one distal end of each longitudinal extension includes a hole; and A pin which is received by the anchoring foot pivot holes and the holes in the longitudinal extensions. Such as the system of claim 1, which further includes: An anchor foot, which includes a first end, a second end, and a pivot hole between the first end and the second end; A first spring component part, which is folded in half around a fold to form two spring component layers; and A pin is received by the pivot holes of the anchor feet and received in the fold. Such as the system of claim 14, which further includes a second spring component part folded on the first spring component part. Such as the system of claim 15, which further includes a third spring component part folded on the second spring component part. Such as the system of claim 1, wherein the beams and the connectors at the extensions of the beams form a shape selected from rectangular, square, race track, oval and circular shapes. Such as the system of claim 1, which further includes at least one anchor head. The system of claim 18, further comprising at least one anchor loader for applying an anchor to the spring member, the at least one anchor loader comprising: An anchor loader body including a tunnel configured to receive the spring member; A plurality of flexible extensions, which come from the anchor loader body, each of the flexible extensions includes an overhanging tip configured to hold the anchor; and A lever arm connected to the anchor loader body, the lever arm being able to move toward the anchor loader body and including a tip that is configured to push an anchor tooth of the anchor head to a final position. The system of claim 19, wherein the at least one anchor loader further comprises at least one detent that is positioned to interact with the spring member to align with any of the windows in the spring member for anchor tooth reception feature. Such as the system of claim 20, wherein the at least one actuation feature may include a V-shaped extension. The system of claim 21, wherein the V-shaped extension is positioned to fit between adjacent connectors extending laterally outward along one of the spring members. Such as the system of claim 21, wherein the V-shaped extension is integrated with an oval base. Such as the system of claim 21, which contains two control features. The system of claim 21, wherein the spring member, the at least one anchor loader, and the at least one detent feature are configured to operate without the spring load of the at least one detent feature. The system of claim 20, wherein the at least one detent feature of the at least one anchor loader is carried by a deflectable beam. The system of claim 26, wherein the at least one anchor carrier includes a slidable collar configured to lock the at least one detent feature using the spring member. The system of claim 19, further comprising at least one spur gear configured and positioned to engage with the spring member between adjacent connectors extending laterally outwardly of one of the spring members. The system of claim 28, which further includes at least one detent feature that interacts with the at least one gear to align any of the windows in the spring member for anchor tooth reception. The system of claim 29, wherein the at least one detent feature includes a detent located at the end of a flexible arm. Such as the system of claim 18, wherein the at least one anchor head includes: An anchor head body comprising a feed port for receiving the spring member, a tooth across the feed port in the anchor head body and the plurality of layers of the spring member, and slidably receive the The tooth is transverse to a channel of the feed port. Such as the system of claim 31, wherein the anchoring head body and the tooth are configured to lock each other. Such as the system of claim 32, wherein when the tooth is fully advanced in the anchor head body, the anchor head body and the tooth are locked. Such as the system of claim 33, wherein the tooth includes at least one deflectable latch component. Such as the system of claim 33, wherein the at least one deflectable latch member is in the form of a hook having a flexible arm and a rotating end, wherein the arm can be relative to a bottom of the anchoring head body in a horizontal direction Deflection and latch. Such as the system of claim 33, wherein the at least one deflectable latch component is in the form of a flexible tang having one end, wherein the tang can be deflected in a vertical direction relative to a bottom of the anchor body to latch Lock. The system of claim 35 or 36, wherein the end of the deflectable latch member is configured to be received in a cavity formed in the anchor head body. Such as the system of claim 31, the at least one anchoring head body includes a first body part and a second body part, the first body part includes a slot for defining the channel with a portion held together, and the The second body part includes at least one recess for receiving a deflectable latch portion of one of the teeth. Such as the system of claim 38, wherein the second body part includes two symmetrically formed and placed recesses. Such as the system of claim 38, wherein at least one of the first body part and the second body part is undercut to define an opposite side slot that separates the anchor head from a base.

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