Force detection bone pin device

Abstract

This invention discloses a force-detecting bone screw device, comprising a bone screw body, a load-bearing structure, a detection module, and an antenna module. The bone screw body includes a column. The load-bearing structure, detection module, and antenna module are respectively disposed within a receiving portion of the column. The load-bearing structure includes a body, a bearing portion, a fixing portion, and at least one moment-strain structure. One end of the body is connected to the bearing portion, and the other end is connected to the fixing portion, which is fixed within the column. One side of the bearing portion is used to connect to a suture. Each moment-strain structure is disposed within the body, the body having an axial direction, and each moment-strain structure having deformation in at least one direction different from the axial direction. The detection module includes at least one strain element and a sensing component. Each strain element is used to measure the stress of the moment-strain generated by the moment-strain structure, and the sensing component is connected to the strain element. The antenna module is connected to the sensing component.

Description

Technical Field

[0001] This invention relates to a bone screw device, and more particularly to a force-detecting bone screw device. Background Technology

[0002] The rotator cuff muscles are a group of tendons located in the shoulder that are responsible for stabilizing the shoulder joint and assisting in shoulder movement. When these tendons are damaged or torn, it can cause shoulder pain and limited range of motion, especially in the elderly, and can even affect daily life. Rotator cuff repair (RCR) surgery is a surgical procedure used to repair injuries to the rotator cuff muscles of the shoulder, reduce shoulder pain, and restore shoulder function, allowing patients to resume daily activities or sports.

[0003] In current techniques, reattachment surgery (RCR) commonly uses specialized fixation devices to stabilize tendons. For example, rivets are inserted deep into the bone and secured with bandages, allowing torn or damaged tendon tissue to reattach to the bone. Post-surgery, patients typically require physical therapy to restore shoulder strength and range of motion, meaning post-operative rehabilitation is necessary. Depending on the type of surgery and the extent of the injury, recovery time can range from several months to a year, leading to prolonged healing periods. Furthermore, excessive rehabilitation can easily cause re-tears. The consequences of tendon re-tears include poorer clinical functional outcomes, accelerated joint degeneration, and greater difficulty in subsequent repairs.

[0004] In addition, during the procedure, the injected material for the rivets may fail, leading to further tearing. Summary of the Invention

[0005] This invention provides a force-detecting bone screw device to address or monitor the failure of the injected material in rivets during surgery and to prevent postoperative rehabilitation from overloading and causing re-tears.

[0006] One embodiment of the present invention provides a force-detecting bone screw device for detecting the force on a suture. The force-detecting bone screw device includes a bone screw body, a load-bearing structure, a detection module, and an antenna module. The bone screw body includes a column having an open end and an insertion end opposite to each other, and a receiving portion inside the column communicating with the open end. The load-bearing structure is disposed in the receiving portion and includes a body, a bearing portion, a fixing portion, and at least one moment-strain structure. One end of the body is connected to the bearing portion, and the other end of the body is connected to the fixing portion. The fixing portion is fixed inside the column and is adjacent to the insertion end. One side of the bearing portion is used to connect to the suture. Each moment-strain structure is disposed in the body, and the body has an axial direction. Each moment-strain structure has deformation in at least one direction different from the axial direction. The detection module is disposed in the receiving portion and includes at least one strain element and a sensing component. Each strain element is used to measure the stress of the moment-strain generated by the moment-strain structure, and one end of the sensing component is connected to the strain element. The antenna module is located in the housing and is connected to the sensing component.

[0007] Based on the above, when an external force is applied to the load-bearing structure of the present invention, the load-bearing structure will have displacement deformation. Through the structural characteristics of the bending moment strain structure, the detection module calculates the applied force as force data based on the voltage change value after the bending moment strain conversion of the corresponding bending moment strain structure. This allows for the assessment of whether the force data exceeds the load, which can avoid the probability of tendon tearing again after suturing and monitor the degree of recovery at this time, thereby achieving the purpose of accelerating healing.

[0008] Furthermore, during surgery, the present invention can serve as a monitoring mechanism for the injection of rivets during surgery, in order to avoid or reduce the occurrence of rivet injection failure.

[0009] Furthermore, in one embodiment of the present invention, the moment-strain structure, in addition to deforming along the axial direction, can also deform along at least one direction different from the axial direction. Accordingly, the structural feature of the moment-strain structure can transform the small strain of the axial force on the load-bearing structure stretched along the axial direction into a larger moment-strain, resulting in corresponding shape strain in both the axial direction and at least one direction different from the axial direction. This allows the detection module to generate a sufficiently large and linear force data signal, thereby improving detection quality and meeting the requirement of miniaturizing the intelligent sensing injection material.

[0010] To make the present invention more apparent and understandable, specific embodiments are described below, and detailed descriptions are provided in conjunction with the accompanying drawings. Attached Figure Description

[0011] Figure 1 This is a schematic diagram of the force detection bone nail device of the present invention;

[0012] Figure 2This is a schematic diagram showing the comparative data of material selection for the load-bearing structure of the present invention;

[0013] Figure 3 This is a perspective view of an embodiment of the force detection bone nail device of the present invention;

[0014] Figure 4 for Figure 3 A three-dimensional diagram of the internal structure of the force detection bone screw device;

[0015] Figure 5 This is a three-dimensional schematic diagram of an embodiment of the load-bearing structure of the present invention;

[0016] Figure 6 This is a perspective view of another embodiment of the load-bearing structure of the present invention;

[0017] Figure 7 This is a perspective view of yet another embodiment of the load-bearing structure of the present invention;

[0018] Figure 8 This is a cross-sectional schematic diagram of another embodiment of the force detection bone nail device of the present invention;

[0019] Figure 9 for Figure 8 A partial three-dimensional schematic diagram of the bone screw body;

[0020] Figure 10 for Figure 8 A perspective view of one embodiment of the bottom cover;

[0021] Figure 11 for Figure 8 A perspective view of an embodiment of the plug;

[0022] Figure 12 This is a schematic diagram of yet another embodiment of the force detection bone nail device of the present invention;

[0023] Figure 13 This is a side view of yet another embodiment of the force detection bone nail device of the present invention;

[0024] Figure 14 This is a three-dimensional schematic diagram of an embodiment of the load-bearing structure and limiting channel of the present invention;

[0025] Figure 15 for Figure 14 A cross-sectional schematic diagram of an embodiment of the load-bearing structure and limiting channel;

[0026] Figure 16 This is a cross-sectional schematic diagram of another embodiment of the load-bearing structure and limiting channel of the present invention;

[0027] Figure 17 This is a schematic diagram of an embodiment of the detection module of the present invention;

[0028] Figure 18 This is a schematic diagram of an embodiment of the full-bridge circuit of the present invention disposed in a load-bearing structure;

[0029] Figure 19 for Figure 17 and Figure 18 A schematic diagram of an embodiment of the sensing signal path and circuit design.

[0030] Symbol Explanation

[0031] 50: Sewing thread

[0032] 60: Hardware equipment

[0033] 100, 200, 300: Force Detection Bone Screw Device

[0034] 110,210,310:Bone nail body

[0035] 112,212: Column

[0036] 112A, 212A: Open end

[0037] 112B, 212B: Insertion terminals

[0038] 114, 214: Threaded steel

[0039] 120, 220, 320, 420: Load-bearing structure

[0040] 122,222,322,422: Ontology

[0041] 124,224: Bearing section

[0042] 126,226: Fixing part

[0043] 130, 230, 530: Detection modules

[0044] 132,232,532: Strain elements

[0045] 134,234,534: Sensing components

[0046] 140, 240: Antenna modules

[0047] 220A: Activity Terminal

[0048] 220B: Fixed end

[0049] 212C: Transfer Structure

[0050] 2124: Protruding structure

[0051] 2126: Groove structure

[0052] 216,316,416: Plug

[0053] 216A: Bottom

[0054] 2161: Plug body

[0055] 2162: Through-hole for seams

[0056] 218: Bottom Cover

[0057] 2182: Anti-rotation structure

[0058] 2184: Cover

[0059] 2222, 3222: Planar part

[0060] 2242: Hole

[0061] 2262: Activating element

[0062] 2264: Bottom Component

[0063] 316A, 416A: Limiting channel

[0064] 5322: Full-bridge circuit

[0065] 5322A: Input terminal

[0066] 5322B: Output terminal

[0067] 5342: Voltage Regulator and Signal Amplifier Circuit

[0068] 5342A: Voltage Regulator

[0069] 5342B: Instrumentation Amplifier

[0070] 5344: Chip

[0071] AX, AX1, AX2: Axial directions

[0072] BX, BX1: Vertical direction

[0073] CA, CA1: Reception section

[0074] CX1: Central axis

[0075] D: Distance

[0076] DA: Strength Data

[0077] FA: Energy

[0078] GA: Snap-fit ​​structure

[0079] GND: Ground terminal

[0080] HA: Containment Section

[0081] MA1: First Material Curve

[0082] MA2: Second Material Curve

[0083] MA3: Third Material Curve

[0084] MA4: Fourth Material Curve

[0085] MA5: Fifth Material Curve

[0086] N1, N2, N3, N4: Resistors

[0087] P1: concave surface

[0088] P2: convex surface

[0089] RA: Chamfer Structure

[0090] RA: Theoretical Curve

[0091] RD: Radial direction

[0092] RS: Current-limiting resistor

[0093] SA, SA1, SA2, SA3, SA4, SA5: Bending moment-strain structures

[0094] TA: Specific tension value

[0095] VDDH: Operating voltage Detailed Implementation

[0096] The following description provides detailed examples and accompanying drawings, but these examples are not intended to limit the scope of the invention. Furthermore, the drawings are for illustrative purposes only and are not drawn to scale. For ease of understanding, the same elements will be designated with the same symbols in the following description.

[0097] The terms "including", "comprising", "having", etc., used in this invention are all open-ended terms, meaning "including but not limited to".

[0098] In the description of the various embodiments, when the terms "first," "second," "third," "fourth," etc. are used to describe elements, they are only used to distinguish these elements from each other and do not limit the order or importance of these elements.

[0099] In the description of the various embodiments, the term "coupled" or "connected" may refer to two or more elements making direct physical or electrical contact with each other, or making indirect physical or electrical contact with each other. "Coupled" or "connected" may also refer to two or more elements operating or moving with each other.

[0100] In the descriptions of the various embodiments, the term "module" refers to a hardware module, that is, a hardware component that occupies space. In other embodiments, the term "module" may also refer to a hardware module plus a software module, that is, a "module" has software programs in addition to hardware components.

[0101] Figure 1 This is a schematic diagram of a force detection bone screw device according to the present invention. Please refer to... Figure 1 The force-detecting bone screw device 100 of the present invention is used to detect the force on a suture 50, which may be tension, or to detect changes in the force or tension of the suture 50. The force-detecting bone screw device 100 may be, for example, a suture anchor inserted into the shoulder as a fixation device to stabilize the tendon during RCR surgery. In other embodiments, the force-detecting bone screw device 100 may be applied to other orthopedic sites depending on the context. The dimensions of the force-detecting bone screw device 100 are, for example, an outer diameter ranging from 2 mm to 30 mm and a length ranging from 5 mm to 500 mm. The dimensions of the screw body 110 are, for example, an outer diameter ranging from 2 mm to 30 mm and a length ranging from 5 mm to 500 mm. The dimensions of the load-bearing structure 120 are, for example, that the diameter or width of the load-bearing structure 120 is between 4 mm and 18 mm, and the thickness of the load-bearing structure 120 is between 0 mm and 10 mm.

[0102] The force detection bone screw device 100 of the present invention includes a bone screw body 110, a spring structure 120, a detection module 130, and an antenna module 140, wherein the spring structure 120, the detection module 130, and the antenna module 140 are respectively disposed in a receiving portion CA within the bone screw body 110.

[0103] The shape of the bone screw body 110 of the present invention can be adjusted according to the actual application scenario. The bone screw body 110 includes a column 112 and selectively provided with a plurality of threads 114, which protrude from the outer surface of the column 112. In other embodiments, the bone screw body 110 may be a three-dimensional structure and its outer surface may not have threads.

[0104] The column 112 has an open end 112A and an insertion end 112B. The open end 112A communicates with the receiving portion CA, and the insertion end 112B is where the bone screw body 110 is inserted into the human bone. The open end 112A allows the suture 50 to be pulled out. Taking a suture anchor as an example, it is used in orthopedic or joint surgery to attach one end of the suture 50 to a human tendon or bone. These bone screw bodies 110 can firmly fix the suture 50 to the bone or other tissue, helping to repair torn ligaments, tendons, or other tissues.

[0105] The load-bearing structure 120 of this invention refers to a structure capable of bearing and sharing external loads or pressures. The load-bearing structure 120 includes a body 122, a bearing portion 124, a fixing portion 126, and a bending moment strain structure SA, meaning the load-bearing structure 120 is designed to withstand deformation under stress measured with a strain gauge. One end of the body 122 is connected to the bearing portion 124, and the other end of the body 122 is connected to the fixing portion 126. The bending moment strain structure SA refers to the structure's strain (deformation) and response caused by bending moment, and the bending moment strain structure SA is located on the body 122.

[0106] The body 122 of the present invention has an axial direction AX, which can be parallel to the length direction of the body 122. The fixing part 126 is fixed to the bottom inside the column 112, that is, the fixing part 126 is adjacent to the insertion end 112B, so that the fixing part 126 serves as a fixed end of the load-bearing structure 120, and one side of the bearing part 124 is connected to the sewing thread 50, which can be stretched along the axial direction AX, that is, the bearing part 124 serves as a movable end of the load-bearing structure 120.

[0107] When the suture 50 is stretched and an external force is applied to the load-bearing structure 120, a moment (bending moment) is generated that causes the moment-strain structure SA to bend. The moment-strain structure SA has a deformation in at least one direction different from the axial direction AX. For example, different deformations will occur at different positions inside the moment-strain structure SA. These deformations are strains.

[0108] In this way, when the suture 50 is pulled up in the axial direction AX, the suture 50 drives the bearing part 124 and its connected body 122 to move in the axial direction AX. Since the fixing part 126 is stationary, when the body 122 moves in the axial direction AX, the bending moment strain structure SA will deform in at least two directions due to the movement of the body 122.

[0109] by Figure 1For example, the moment-strain structure SA can deform in two directions, in addition to deforming along the axial direction AX.

[0110] The detection module 130 of the present invention includes a strain element 132 and a sensing component 134. One end of the sensing component 134 is connected to the strain element 132, and the other end of the sensing component 134 is connected to the antenna module 140 to form a sensing and wireless output structure.

[0111] Strain element 132 is used to measure the stress caused by the bending moment strain generated by the bending moment strain structure SA in the body 122. Strain element 132 is located at a corresponding position in the bending moment strain structure SA within the body 122. Strain element 132 can be a strain gauge or a piezoelectric material structure to measure force. The strain gauge is made of a conductive material and is used to measure the stress caused by the bending moment strain generated by the force applied to the bending moment strain structure SA. Piezoelectric materials (such as certain crystals or ceramics) exhibit the piezoelectric effect; when a piezoelectric material is subjected to the stress of the bending moment strain generated by the bending moment strain structure SA, a voltage is generated on its surface. The magnitude of this voltage is proportional to the applied force and can be used to measure the magnitude of force or pressure.

[0112] When the suture 50 moves the bearing part 124 and its connected body 122 along the axial direction AX, applying force to the load-bearing structure 120, the bending moment strain structure SA deforms, causing a change in the resistance value of the strain element 132. The change in resistance is converted into an electrical signal and transmitted to the sensing component 134 to form a voltage change. The sensing component 134 then measures and uses this to calculate the applied force as a force data DA.

[0113] Since the force detection bone screw device 100 is a miniaturized intelligent sensing injector, the size of the load-bearing structure 120 is also miniaturized. If only the small strain of the axial force in the axial direction AX when the load-bearing structure 120 is stretched is used, the force corresponding to it can be converted into a small signal, making detection difficult and the signal weak. However, the moment-strain structure SA of the present invention can deform not only along the axial direction AX, but also along the perpendicular direction BX. Accordingly, the structural feature of the moment-strain structure SA can convert the small strain of the axial force of the load-bearing structure 120 stretched along the axial direction AX into a larger moment-strain, so that there are corresponding shape strains in both the axial direction AX and the perpendicular direction BX. This allows the detection module 130 to generate a sufficiently large and linear force data DA corresponding to the signal, thereby improving the detection quality and meeting the miniaturization requirements of the intelligent sensing injector.

[0114] In one application example, during exercise or rehabilitation, the tension of the suture 50 changes as the joint moves, causing the suture 50 to exert a force on the load-bearing structure 120, resulting in displacement deformation of the load-bearing structure 120. Based on the structural characteristics of the moment-strain structure SA, the detection module 130 calculates the applied force as force data DA according to the voltage change value after the moment-strain conversion of the corresponding moment-strain structure SA. This allows for the assessment of whether the force data DA exceeds the load capacity, which can avoid the probability of tendon re-tear after suturing and monitor the degree of recovery at this time, thereby achieving the purpose of accelerating healing.

[0115] Furthermore, during surgery, this invention can serve as a monitoring mechanism to monitor the injection of rivets during the procedure, thereby avoiding or reducing rivet injection failure.

[0116] In one embodiment, Figure 1 Both the load-bearing structure 120 and the bone nail body 110 shown can be made of polyetheretherketone (PEEK), forming a PEEK structure. PEEK is a thermoplastic plastic with high temperature resistance, mechanical strength, chemical stability, electrical insulation, and biocompatibility. PEEK can be used at high temperatures for extended periods and can withstand even higher temperatures in short periods. PEEK has high tensile strength, hardness, and abrasion resistance, making it suitable for applications requiring high strength. PEEK has strong resistance to most chemicals. PEEK has good electrical insulation properties, thus it can be used in the electronic modules and communication modules used in this invention. PEEK has been widely used in the medical field, especially in smart sensing injectables, where its biocompatibility allows for safe use in the human body.

[0117] In addition, the bone nail body 110 is made of PEEK material instead of metal, which can avoid shielding and affecting the operation of the antenna module 140.

[0118] In other embodiments, the materials of the bone nail body 110 and the load-bearing structure 120 may also be non-magnetic metals, forming a non-magnetic metal structure, such as stainless steel or titanium alloy, which has anti-magnetic properties.

[0119] Figure 2 This is a schematic diagram showing comparative data on the selection of materials for the load-bearing structure according to the present invention. Please refer to... Figure 2 , Figure 2 The horizontal axis represents displacement, and its unit is millimeters (mm); Figure 2 The vertical axis represents the load, and its unit is Newton (N); Figure 2A theoretical curve RA is used, and five material curves MA1, MA2, MA3, MA4, and MA5 are obtained through experiments using five materials as load-bearing structures. The first material curve MA1 is the data obtained using PEEK as the load-bearing structure, the second material curve MA2 is the data obtained using 4K_3DP (high-strength 3D printing engineering resin) as the load-bearing structure, the third material curve MA3 is the data obtained using 2K_3DP (low-strength 3D printing engineering resin) as the load-bearing structure, the fourth material curve MA4 is the data obtained using PP (polypropylene) as the load-bearing structure, and the fifth material curve MA5 is the data obtained using HDPE (high-density polyethylene) as the load-bearing structure.

[0120] Figure 2 The results show that, compared to the faster decline in the curve trends of the second material curve MA2, the third material curve MA3, the fourth material curve MA4, and the fifth material curve MA5, the first material curve MA1 closely approximates the theoretical curve RA under a tension load of 100N, demonstrating that the load-bearing structure 120 of the present invention exhibits a wider tension detection range using PEEK material. Furthermore, at a specific tension value TA of 30N, the first material curve MA1 exhibits linearity, showing that the displacement energy of the load-bearing structure 120 using PEEK material is directly proportional to the tension load data. In one embodiment, the load-bearing structure 120 using PEEK material has a tension detection range of 0 to 3 kgf, where 3 kgf is approximately 30 Newtons.

[0121] Furthermore, by taking advantage of the structural features of the bending moment strain structure SA, the small strain of the axial force stretched by the load-bearing structure 120 along the axial direction AX can be transformed into a larger bending moment strain, so that the detection module 130 generates a signal corresponding to a sufficiently large and linear force data DA, which can greatly improve the detection quality.

[0122] The antenna module 140 of this invention is capable of wireless communication (such as Wi-Fi, Bluetooth, 4G / 5G). Force data DA is transmitted via the antenna module 140 to an external hardware device 60, which then calculates the status of the force data DA. The hardware device 60 may be, for example, a handheld electronic device or a cloud-based device.

[0123] In one alternative embodiment, hardware device 60 can transmit energy FA, ​​such as electricity, to antenna module 140 in force-detecting screw device 100, thereby charging force-detecting screw device 100 through antenna module 140 and providing a battery-free device. Of course, in other embodiments, force-detecting screw device 100 can be charged in other ways.

[0124] Figure 3 This is a perspective view of an embodiment of a force detection bone nail device according to the present invention. Figure 4 In accordance with Figure 3 A three-dimensional diagram of the internal structure of the force detection bone screw device. Figure 5 This is a perspective view of an embodiment of a load-bearing structure according to the present invention. Please refer to... Figure 3 , Figure 4 and Figure 5 To illustrate an embodiment of an application structure, the force detection bone nail device 200 of the present invention includes a bone nail body 210, a load-bearing structure 220, a detection module 230, and an antenna module 240.

[0125] The bone screw body 210 includes a cylinder 212, multiple threads 214, and a bottom cover 218. The threads 214 protrude from the outer surface of the cylinder 212. The bottom cover 218 is disposed and closed at the bottom of the cylinder 212. The cylinder 212 can be a cylindrical structure or any other three-dimensional structure. The threads 214 can be screwed in by the user or their shape can be changed according to the actual situation. The cylinder 212 has an open end 212A and an insertion end 212B opposite to each other. One side of the bottom cover 218 is the insertion end 212B. The open end 212A communicates with the receiving part CA1. The insertion end 212B is the end of the bone screw body 210 inserted into the human bone, while the open end 212A is for the suture 50 to be pulled out.

[0126] The load-bearing structure 220, the detection module 230, and the antenna module 240 are respectively housed in the receiving portion CA1 within the bone nail body 110. The load-bearing structure 220 of this invention includes a body 222, a bearing portion 224, a fixing portion 226, and two moment-strain structures SA1 and SA2; that is, the load-bearing structure 220 serves as a structure for measuring the deformation under stress using a strain gauge. One end of the body 222 is connected to the bearing portion 224, and the other end of the body 222 is connected to the fixing portion 226. The antenna module 240 may be a hollow ring structure and is disposed outside the fixing portion 226.

[0127] The body 222 of the present invention can be a plate having an axial direction AX1, which can be parallel to the length direction of the body 222. The two moment-strain structures SA1 and SA2 can be structures for the structural strain (deformation) and response caused by the bending moment, and are respectively located at different positions of the body 222.

[0128] The detection module 230 is connected to the antenna module 240. The detection module 230 includes two strain elements 232 and a sensing component 234. The two strain elements 232 are respectively disposed on the bending moment strain structures SA1 and SA2. In this embodiment, the main body 222 of the load-bearing structure 220 and its connected bearing part 224 are connected to the fixed part 226 in an eccentric setup, that is, the main body 222 and its connected bearing part 224 are offset from a central axis CX1 or a central position of the fixed part 226.

[0129] Because the main body 222 and the supporting portion 224 connected thereto are eccentrically arranged, there is still accommodating space on the lower end side of the main body 222. The sensing component 234 can be disposed on the lower end side of the main body 222, so that the sensing component 234 can be located between the fixing portion 226 and the antenna module 240, thereby reducing the accommodating space of the accommodating portion CA1 in the bone nail body 210. In other embodiments not shown, depending on the actual structural configuration or requirements, the main body and the supporting portion connected thereto can be disposed on the central axis or center position of the fixing portion, and the sensing component can be connected to one side of the supporting portion.

[0130] by Figure 5 For example, the load-bearing structure 220 has a movable end 220A and a fixed end 220B. The fixed part 226 is fixed to the bottom inside the column 212, so that the fixed part 226 serves as a fixed end 220B of the load-bearing structure 120. The bearing part 224 has a hole 2242, which can be connected to the sewing thread 50, so that the sewing thread 50 can be stretched upward in the axial direction AX1.

[0131] The fixing part 226 includes a locking element 2262 and a bottom element 2264. The locking element 2262 is connected between the body 222 and the bottom element 2264. The other side of the bottom element 2264 is the fixing end 220B of the load-bearing structure 220. The bottom cover 218 is disposed and closed on the bottom of the column 212, and the bottom element 2264 is disposed on one side of the bottom cover 218. In one embodiment, the bottom element 2264 can rest against the bottom cover 218.

[0132] The engaging element 2262 and the bottom element 2264 of the present invention are both cylinders. The difference is that the size of the engaging element 2262 is smaller than that of the bottom element 2264, so that the engaging element 2262 has an engaging structure GA. The engaging structure GA is used to connect to the cylinder 212 and can stabilize the fixed end 220B of the load-bearing structure 220 in the position of the bone nail body 110.

[0133] These two moment-strain structures, SA1 and SA2, each have deformation in at least one direction different from the axial direction AX1. Figure 5 For example, the two moment-strain structures SA1 and SA2 are actually recessed or curved structures of the body 222. The body 222 has a planar portion 2222, and the moment-strain structures SA1 and SA2 are recessed or curved structures that are recessed or bent from the surface of the planar portion 2222. Alternatively, the moment-strain structures SA1 and SA2 are structures that are not parallel to the surface of the planar portion 2222. This allows the two moment-strain structures SA1 and SA2 to deform not only along the axial direction AX1 but also along a direction perpendicular to the axial direction AX1, where the perpendicular direction BX1 is a direction perpendicular to the body 222, for example, the normal direction of the body 222. Through this structural configuration, the two moment-strain structures SA1 and SA2 can be structures that respond to structural strain (deformation) caused by bending moment.

[0134] In other embodiments, such as Figure 6 The load-bearing structure 320 shown is related to Figure 5 The difference in the load-bearing structure 220 shown is that the number of moment-strain structures SA3 is one. That is to say, Figure 6 The moment-strain structure SA3 is a curved or recessed position of the planar portion 3222 in the body 322.

[0135] In other structural embodiments, such as Figure 7 The load-bearing structure 420 shown is related to Figure 5 The load-bearing structure 220 shown Figure 6 The difference in the load-bearing structure 320 shown is that a receiving portion HA is provided at the center of the main body 422 to form the upper bending moment strain structure SA4 and the lower bending moment strain structure SA5. That is, the receiving portion HA is a receiving space between the bending moment strain structure SA4 and the bending moment strain structure SA5. The bending moment strain structure SA4 and the bending moment strain structure SA5 are curved structures compared to the bearing portion 224.

[0136] Depend on Figures 4 to 7It can be seen that the bending moment strain structures SA1, SA2, SA3, SA4, and SA5 in this embodiment are three-dimensional arcuate (non-linear) configurations of the load-bearing structures 220, 320, and 420, which can generate bending strain regions and locally generate stress concentration regions. By generating stress concentration regions locally, the small strain of the axial force stretched by the load-bearing structures 220, 320, and 420 along the axial direction AX can be transformed into a larger bending moment strain.

[0137] like Figure 5 As shown, the moment-strain structure SA1 has a concave surface P1 and a convex surface P2, and as... Figure 4 The strain element 232 can be disposed on the concave surface P1. In other embodiments, the strain element can also be disposed on the convex surface, such that the strain element can be disposed at one of the concave surface P1 and the convex surface P2. Similarly, the method of disposing the strain element 232 on the concave surface P1 and the convex surface P2 of the moment-strain structure SA1 can be applied to the moment-strain structure SA2 and Figure 6 The moment-strain structure SA3.

[0138] exist Figure 7 In the middle, it can be like Figure 4 The strain element 232 is disposed within the housing HA, and the deformation of the bending moment strain structures SA4 and SA5 can also be detected. Alternatively, it can be used as follows: Figure 4 The strain element 232 is disposed on the outer surface of the bending moment strain structure SA4 and SA5.

[0139] Figure 8 This is a cross-sectional schematic diagram of another embodiment of the force detection bone nail device according to the present invention. Figure 9 In accordance with Figure 8 A partial three-dimensional schematic diagram of the bone nail body. Figure 10 In accordance with Figure 8 A perspective view of one embodiment of the bottom cover. Figure 11 In accordance with Figure 8 A perspective view of one embodiment of the plug. Please refer to... Figures 8 to 11 , Figure 8 Force detection bone nail device 200 can provide Figure 3A cross-sectional schematic diagram of the force detection bone screw device 200. A protruding structure 2124 is provided within the column 212. The protruding structure 2124 is a flange on the inner surface of the column 212 and is located within the receiving portion CA1. The load-bearing structure 220 can be inserted into the column 212 through the insertion end 212B until the engaging structure GA abuts against the protruding structure 2124, thereby securing the protruding structure 2124 to the engaging structure GA and fixing the position of the load-bearing structure 220. In other embodiments not shown, the load-bearing structure 220 and the column 212 may have other mutual engagement mechanisms such as shape-fitting (e.g., concave-convex joint) mechanisms, all of which are structures with similar and equivalent effects to those in this embodiment.

[0140] Next, the bottom cover 218 is placed and closed at the bottom of the column 212, and the bottom element 2264 can rest against the bottom cover 218. In one embodiment, a groove structure 2126 is provided at the bottom of the column 212, which is a notch at the bottom of the column 212. The bottom cover 218 includes an anti-rotation structure 2182 and a cover body 2184. The anti-rotation structure 2182 is connected to the cover body 2184. The bottom of the cover body 2184 is flat. The anti-rotation structure 2182 is screwed into the column 212 by screwing, and the cover body 2184 is connected to the groove structure 2126 through the side edge of the cover body 2184, so that the bottom cover 218 is connected to the column 212.

[0141] Furthermore, the anti-rotation structure 2182 of the bottom cover 218 is designed to prevent it from spinning and falling off. The shape of the anti-rotation structure 2182 is as follows: Figure 10 The structure is hexagonal. In other embodiments not shown, the anti-rotation structure may be polygonal or other shaped structures, and any shape that can prevent rotation is within the scope of this invention.

[0142] On the other hand, a insertion structure 212C is provided within the column 212 near the opening end 212A. The insertion structure 212C is, for example, an internal hexagonal structure within the column 212, providing a position for the user to engage with the bone screw body 210 using a tool (such as a hex wrench). In other embodiments, the shape of the insertion structure 212C can be adjusted according to the tool; that is, the shape of the insertion structure 212C can be different, and any ability to rotate the insertion structure 212C into the bone during surgery is within the scope of this invention.

[0143] like Figure 8 and Figure 11As shown, the bone screw body 210 also includes a plug 216, which is a recessed plug. The plug 216 is located below the insertion structure 212C to prevent self-rotation, and the plug 216 is located above the load-bearing structure 220, so that the plug 216 is positioned between the insertion structure 212C and the load-bearing structure 220. In one embodiment, the bottom 216A of the plug 216 is separated from one side of the bearing portion 224 in the load-bearing structure 220 by a distance D, so that when the load-bearing structure 220 is stretched by the suture and displaced, it will not touch the plug 216.

[0144] The plug 216 includes a plug body 2161 and a suture through-hole 2162. The plug body 2161 is, for example, a cylinder. The suture through-hole 2162 is located at the center of the plug body 2161, allowing the suture to pass through from the load-bearing structure 220 side and exit outside the bone screw body 210. In one embodiment, such as... Figure 4 The antenna module 240 can be combined with the plug 216, or the antenna module 240 can be connected to one side of the plug 216, both of which are structures with similar and equivalent effects in this embodiment. In one embodiment, the axial direction AX1 of the load-bearing structure 220 passes through the seam through hole 2162, thus having a limiting function.

[0145] Figure 12 This is a schematic diagram of yet another embodiment of the force detection bone nail device according to the present invention. Figure 13 This is a side view of yet another embodiment of the force detection bone nail device according to the present invention. Please refer to... Figures 12 to 13 The force detection bone nail device 300 of the present invention and Figure 8 The difference in the force detection screw device 200 is that the plug 316 in the screw body 310 is provided with a positioning pin hole 316A, and the diameter of the positioning pin hole 316A can be smaller than that of... Figure 8 The diameter of the suture through hole 2162 is greater than the size of the suture 50, so that the suture 50 can pass through.

[0146] In addition to its smaller diameter, the limiting channel 316A of the present invention can restrict the movement of the suture 50 in the radial direction RD within the limiting channel 316A. In one embodiment, as... Figure 12 and Figure 13 As shown, the axial direction AX1 of the load-bearing structure 220 passes through the limiting channel 316A. The structural arrangement of the limiting channel 316A, and the positional conditions between the limiting channel 316A and the load-bearing structure 220, ensure that the force applied by the thread 50 is along the axial direction AX1 of the load-bearing structure 220, thus limiting the tension of the thread 50 to the axial direction AX1 of the load-bearing structure 220. In other words, the positional arrangement of the limiting channel 316A ensures that the applied force is oriented and fixed, solving the problem of non-axial force components. It should be noted that in one embodiment, Figure 11 The seam through-hole 2162 of the plug 216 can also have the limiting function of the limiting channel 316A by adopting the position conditions of this embodiment.

[0147] Figure 14 This is a perspective view of an embodiment of the load-bearing structure and limiting channel according to the present invention. Figure 15 In accordance with Figure 14 A cross-sectional schematic diagram of an embodiment of the load-bearing structure and limiting channel. Please refer to... Figure 14 and Figure 15 In terms of setting the height direction, for example, using Figure 7 The load-bearing structure 420 is positioned at the same height as the limiting channel 316A, so that the axial direction AX2 of the load-bearing structure 420 passes through the limiting channel 316A, which also achieves the effect of limiting the tension of the sewing thread 50 in the axial direction AX2 of the load-bearing structure 420.

[0148] Furthermore, the inner surface of the limiting channel 316A can be a smooth structure. For example, the inner surface of the limiting channel 316A can be made smoother through surface treatment to improve the smoothness of the suture 50 passing through the limiting channel 316A.

[0149] However, the present invention is not limited thereto, such as Figure 16 As shown, the edge of the limiting hole 416A of the plug 416 can be chamfered to have a chamfered structure RA, which allows the suture 50 to move along the curve of the chamfered structure RA, thereby improving the ease of use of the suture for stretching.

[0150] Figure 17 This is a schematic diagram of an embodiment of the detection module according to the present invention. Figure 18 This is a schematic diagram of an embodiment of a full-bridge circuit according to the present invention installed in a load-bearing structure. Please refer to [link / reference]. Figure 17 and Figure 18 The detection module 530 of the present invention includes a strain element 532 and a sensing component 534, wherein the strain element 532 includes a full bridge circuit 5322.

[0151] Sensing component 534 includes a voltage regulator and signal amplifier circuit 5342 and a chip 5344. A full-bridge circuit 5322 is connected to the voltage regulator and signal amplifier circuit 5342, and the voltage regulator and signal amplifier circuit 5342 is connected to the chip 5344. The chip 5344 may include an NFC (Near Field Communication) chip or an RFID IC (Radio Frequency Identification Integrated Circuit), which cooperates and connects to, for example, an NFC chip or an RFID IC. Figure 1The antenna module 140 and hardware device 60 shown can achieve passive charging. Of course, in other embodiments, charging can be performed through an external power source or other methods.

[0152] In one embodiment, to reduce size or volume, the full-bridge circuit 5322, the voltage regulator and signal amplifier circuit 5342, and the chip 5344 can be designed as a single module.

[0153] The 5322 full-bridge circuit, such as the Wheatstone Bridge circuit, is used to measure changes in physical quantities such as strain, temperature, and pressure, especially in applications involving strain gauges and other sensors. Figure 18 As shown, with Figure 4 Taking the load-bearing structure 220 as an example, each of the two moment-strain structures SA1 and SA2 is equipped with a strain element 532. One strain element 532 is equipped with two resistors N1 and N2, forming a half-bridge circuit, and the other strain element 532 is equipped with two resistors N3 and N4, forming another half-bridge circuit. Therefore, the two strain elements 532 have two half-bridge circuits and four resistors N1, N2, N3, and N4. These four resistors N1, N2, N3, and N4 will form a bridge structure, constituting a full-bridge circuit 5322. The aforementioned resistors N1, N2, N3, and N4 can be variable resistors (VR). In other embodiments not shown, one, two, or four variable resistors can be set on one strain element depending on the actual situation. If there are four variable resistors, a Wheatstone full-bridge circuit can be formed.

[0154] With the above configuration, this embodiment can integrate an NFC chip or RFID IC and a strain element 532 containing a full-bridge circuit 5322 to achieve and achieve the goal of low power consumption (less than 1mW).

[0155] Figure 19 In accordance with Figure 17 and Figure 18 A schematic diagram of an embodiment of the sensing signal path and circuit design. Please refer to [link / reference]. Figures 17 to 19In this embodiment, the voltage regulation and signal amplification circuit 5342 is integrated into the aforementioned chip 5344 and the strain gauge 532, which includes a full-bridge circuit 5322. The voltage regulation and signal amplification circuit 5342 is an amplification circuit design, which includes a voltage regulator 5342A and an instrumentation amplifier (INA) 5342B. The voltage regulator 5342A is electrically connected to the instrumentation amplifier 5342B, and the instrumentation amplifier 5342B is electrically connected to the chip 5344. One end of the full-bridge circuit 5322 is connected to a current-limiting resistor RS, for example, 2900 ohms. One end of the current-limiting resistor RS is grounded (GND) to reduce the current. In this embodiment, the current is limited to 165 micro-amps by the current-limiting resistor RS. The input terminal 5322A of the full-bridge circuit 5322 is connected to the voltage regulator 5342A, and the output terminal 5322B of the full-bridge circuit 5322 is connected to the instrumentation amplifier 5342B. With this circuit setup, the operating voltage VDDH, for example, is a 1.9-volt power input induced by RF. The voltage regulator 5342A and the instrumentation amplifier 5342B perform input voltage modulation and regulation, and signal gain amplification functions. Furthermore, the full-bridge circuit 5322... Figure 1 The resistance value of the bending moment strain of the bending moment strain structure SA shown is converted into a voltage change value and input to the instrumentation amplifier 5342B. After integration and conversion, the voltage change value is transmitted to the chip 5344. The chip 5344 has an ADC analog-to-digital converter function, which can convert the voltage change value into a voltage change value such as... Figure 1 The power data DA is wirelessly transmitted to an external hardware device 60.

[0156] In summary, when an external force is applied to the load-bearing structure of this invention, displacement deformation occurs. By utilizing the structural characteristics of the moment-strain structure, the detection module calculates the applied force as force data based on the voltage change value after the moment-strain conversion of the corresponding moment-strain structure. This allows for the assessment of whether the force data exceeds the load capacity, thereby avoiding the probability of tendon re-tear after suture and monitoring the degree of recovery at this time, thus achieving the goal of accelerating healing.

[0157] Furthermore, during surgery, the present invention can serve as a monitoring mechanism for the injection of rivets during surgery, in order to avoid or reduce the occurrence of rivet injection failure.

[0158] Furthermore, in one embodiment of the present invention, the moment-strain structure, in addition to deforming along the axial direction, can also deform along at least one direction different from the axial direction. Accordingly, the structural feature of the moment-strain structure can transform the small strain of the axial force on the load-bearing structure stretched along the axial direction into a larger moment-strain, resulting in corresponding shape strain in both the axial direction and at least one direction different from the axial direction. This allows the detection module to generate a sufficiently large and linear force data signal, thereby improving detection quality and meeting the requirement of miniaturizing the intelligent sensing injection material.

[0159] Furthermore, in one embodiment of the present invention, polyetheretherketone (PEEK) is used as the material for the load-bearing structure and the bone nail body. In the smart sensing injection, the biocompatibility of PEEK allows for safe use in the human body.

[0160] In addition, the displacement of load-bearing structures made of PEEK material is directly proportional to the load data of tension and has a linear relationship. Combined with the structural characteristics of moment-strain structures, it can not only transform the small strain of the axial force of the load-bearing structure under tension into a large moment-strain, but also generate a signal corresponding to sufficiently large and linear force data, which can greatly improve the detection quality.

[0161] Furthermore, the axial direction of the load-bearing structure of the present invention is through a limiting channel. The structural arrangement of this limiting channel, and the positional conditions between the limiting channel and the load-bearing structure, ensure that the force applied to the seam is along the axial direction of the load-bearing structure, thus limiting the seam tension to the axial direction of the load-bearing structure. In other words, the positional arrangement of the limiting channel allows the force application conditions to be oriented and fixed, solving the problem of non-axial force components.

[0162] Furthermore, in one embodiment of the present invention, the edge of the limiting channel can be chamfered to form a chamfered structure, which allows the suture to move along the curve of the chamfered structure, or the inner surface of the limiting channel can be made smoother through surface treatment, which can improve the convenience of suture stretching and use.

[0163] In addition, this invention integrates an NFC chip or RFID IC and an antenna module to achieve passive charging functionality.

[0164] Furthermore, this embodiment can integrate an NFC chip or RFID IC, as well as strain gauges and a full-bridge circuit, to achieve and achieve low power consumption (less than 1mW).

[0165] In addition, the amplifier circuit design is further integrated into the aforementioned NFC chip or RFID IC, as well as the strain element and full-bridge circuit, and can harvest energy through external sensing.

[0166] Although the present invention has been disclosed above by way of embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications and refinements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be defined by the appended claims.

Claims

1. A force-detecting bone screw device for detecting the force on a suture, the force-detecting bone screw device comprising: The bone nail body includes a column having an opposing open end and an insertion end, and a receiving portion within the column communicating with the open end. A load-bearing structure is provided in the receiving portion. The load-bearing structure includes a body, a bearing portion, a fixing portion, and at least one moment strain structure. One end of the body is connected to the bearing portion, and the other end of the body is connected to the fixing portion. The fixing portion is fixed inside the column and is adjacent to the insertion end. One side of the bearing portion is used to connect to the seam. Each moment strain structure is provided in the body. The body has an axial direction, and each moment strain structure has deformation in at least one direction different from the axial direction. A detection module is disposed in the receiving portion. The detection module includes at least one strain element and a sensing component. Each strain element is used to measure the stress of the bending moment strain generated by the bending moment strain structure. One end of the sensing component is connected to the strain element. as well as An antenna module is disposed in the receiving portion, and the antenna module is connected to the sensing component.

2. The force detection bone nail device as claimed in claim 1, wherein each of the strain elements is disposed at a corresponding position in the body corresponding to the bending moment strain structure.

3. The force detection bone screw device as claimed in claim 2, wherein the at least one moment strain structure has opposing concave and convex surfaces, and the at least one strain element can be disposed at one of the concave and convex surfaces.

4. The force detection bone nail device as claimed in claim 2, wherein the at least one moment strain structure is a concave structure or a bending structure of the body.

5. The force detection bone nail device as claimed in claim 1, wherein the strain element is a strain gauge or a piezoelectric material structure.

6. The force detection bone nail device as claimed in claim 1, wherein the bone nail body includes a plug, the plug being provided with a limiting channel through which the axial direction of the load-bearing structure passes.

7. The force detection bone nail device as described in claim 6, wherein the height of the load-bearing structure is the same as the height of the limiting channel.

8. The force detection bone nail device as claimed in claim 6, wherein the inner surface of the limiting channel has a smooth structure.

9. The force detection bone nail device as claimed in claim 6, wherein the edge of the limiting channel has a chamfered structure.

10. The force detection bone nail device as claimed in claim 1, wherein the bone nail body includes a plug, a turning structure is provided inside the cylinder near the opening end, the turning structure is an internal hexagonal structure inside the cylinder, the plug is disposed between the turning structure and the load-bearing structure, and the plug includes a suture through hole.

11. The force detection bone nail device as claimed in claim 1, wherein the fixing part includes a locking element and a bottom element, the locking element is connected between the body and the bottom element, the locking element has a locking structure, and a protruding structure is provided inside the column, the protruding structure being secured to the locking structure.

12. The force-detecting bone nail device as claimed in claim 1, wherein the material of the load-bearing structure is polyetheretherketone.

13. The force-detecting bone nail device as claimed in claim 1, wherein the material of the load-bearing structure is a non-magnetic metal.

14. The force-detecting bone screw device as claimed in claim 1, wherein the material of the bone screw body is polyetheretherketone.

15. The force detection bone nail device as claimed in claim 1, wherein the material of the bone nail body is a non-magnetic metal.

16. The force detection bone nail device as claimed in claim 1, wherein the bone nail body includes a bottom cover disposed and closed at the bottom of the column, and one side of the bottom cover is the insertion end.

17. The force detection bone nail device as claimed in claim 16, wherein the column is provided with a groove structure, the bottom cover includes an anti-rotation structure and a cover body, the anti-rotation structure is connected to the cover body, the anti-rotation structure is placed inside the column, and the side edge of the cover body is engaged with the groove structure.

18. The force detection bone nail device as claimed in claim 1, wherein the bone nail body includes a plurality of threads, the threads being respectively protruding from the outer surface of the cylinder.

19. The force detection bone screw device as claimed in claim 1, wherein each strain element comprises a full-bridge circuit.

20. The force detection bone screw device as claimed in claim 19, wherein the sensing component includes a voltage regulator and signal amplification circuit and a chip, the full-bridge circuit is connected to the voltage regulator and signal amplification circuit, the voltage regulator and signal amplification circuit is connected to the chip, and the chip is connected to the antenna module.

21. The force detection bone screw device as claimed in claim 20, wherein the voltage regulation and signal amplification circuit includes a voltage regulator and an instrumentation amplifier.

22. The force detection bone screw device of claim 20, wherein the chip includes an NFC chip.

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