Biodegradable sternum fixing device

Abstract

The utility model discloses a biodegradable sternum fixing device. The biodegradable sternum fixing device comprises a belt body, a tip structure and a fixing clamping head, wherein the tip structure and the fixing clamping head are located at the two ends of the belt body respectively. A plurality of tooth blocks which are uniformly distributed are arranged on the surface of one side of the belt body, and the surface of the other side of the belt body is a smooth surface; the fixed clamping head comprises a shell of a concentric-square-shaped structure and an elastic block arranged on the inner wall of the shell, and the elastic block is correspondingly matched with the tooth block in structure. The two ends of the shell are an inlet end and an outlet end respectively, wherein the tip structure drives the belt body to penetrate in and out through the inlet end and the outlet end. The shell comprises a third release layer, a second release layer and a first release layer which are sequentially stacked from inside to outside, the third release layer comprises bone healing promoting drug molecules and antibacterial drug molecules, and the second release layer comprises wound healing promoting drug molecules and antibacterial drug molecules. The first release layer comprises anti-inflammatory drug molecules and antibacterial drug molecules. The method has the advantages of high practicability, low risk and capability of promoting wound healing of a patient.

Description

Technical Field

[0001] The utility model relates to the technical field of medical equipment for cardiovascular surgery, and more particularly to a biodegradable sternum fixation device. Background Art

[0002] Cardiac surgery is a vital area of ​​cardiovascular disease treatment, and its procedures include congenital heart disease, coronary artery bypass grafting, and heart valve replacement. Cardiac surgery requires splitting the patient's sternum midway to expose the heart for surgical intervention. After the procedure, the two halves of the split sternum are reattached using stainless steel wire.

[0003] When stainless steel wire is used to fix the sternum, contact with the patient's underlying tissue often causes poor wound healing. Furthermore, as a foreign body, the wire requires a second surgery to remove after the sternum has healed. Scar tissue forms during bone healing after the initial surgery, and this dense scar tissue increases the difficulty of wire removal. This can result in prolonged surgery and the need for more delicate manipulation to avoid damage to surrounding tissue. Furthermore, a second surgery may involve more incisions and procedures, as well as the presence of scar tissue, which can increase the risk of infection and exacerbate the patient's suffering. Utility Model Content

[0004] In view of the above problems, the purpose of the present invention is to provide a biodegradable sternum fixation device.

[0005] In order to achieve the above purpose, the utility model adopts the following technical solutions:

[0006] A biodegradable sternum fixation device comprising:

[0007] A belt body and a tip structure and a fixing clamp respectively located at two ends of the belt body;

[0008] One side surface of the belt body includes a plurality of evenly distributed tooth blocks, and the other side surface of the belt body is a smooth surface;

[0009] The fixed clamp includes a shell with a circular structure and a spring block provided on the inner wall of the shell, wherein the spring block and the tooth block are structured to correspond to each other;

[0010] The two ends of the shell are respectively an inlet end and an outlet end for the tip structure to drive the belt body to pass in and out;

[0011] The shell includes a third release layer, a second release layer and a first release layer stacked in sequence from the inside to the outside, the third release layer includes bone healing promoting drug molecules and antibacterial drug molecules, the second release layer includes wound healing promoting drug molecules and antibacterial drug molecules, and the first release layer includes anti-inflammatory drug molecules and antibacterial drug molecules.

[0012] In addition, an optional solution is that the elastic block includes a connecting portion formed by a protrusion on the inner wall of the shell, and a contact portion formed by an end portion of the connecting portion extending toward the outlet end;

[0013] The surface of the contact portion includes teeth correspondingly matched with the tooth block.

[0014] In addition, an optional solution is that the elastic block divides the inner cavity of the shell into an adjustment cavity and a connection cavity;

[0015] The adjustment cavity is the portion between the contact portion and the inner wall where the elastic block is located;

[0016] The connecting cavity is the portion between the bullet block and the inner wall opposite to the inner wall where it is located, and the connecting cavity is connected to the inlet end and the outlet end;

[0017] The teeth are arranged to protrude from the surface of the contact portion and are located in the connecting cavity.

[0018] In addition, an optional solution is that the tip structure is formed by gradually converging one end of the belt body away from the fixing clamp.

[0019] In addition, an optional solution is that the tip structure is a steel needle, which is fixed to the end of the belt body away from the fixed clamp.

[0020] In addition, an optional solution is that the side of the belt body with the tooth block includes a recessed slot, and the tooth block is formed in the slot.

[0021] In addition, an optional solution is that the tooth block is arranged to protrude from the surface where it is located.

[0022] In addition, an optional solution is that the belt body and the fixing clamp are both made of biodegradable materials;

[0023] The third release layer is formed by blending bone healing promoting drug molecules, antibacterial drug molecules and biodegradable materials;

[0024] The second release layer is formed by blending wound healing promoting drug molecules, antibacterial drug molecules and biodegradable materials;

[0025] The first release layer is formed by blending anti-inflammatory drug molecules, antibacterial drug molecules and biodegradable materials.

[0026] In addition, an optional solution is that the biodegradable material is a polylactic acid material or a polycaprolactone material.

[0027] In addition, an optional solution is that the bone healing promoting drug molecules include teripatate;

[0028] The wound healing promoting drug molecules include recombinant human epidermal growth factor;

[0029] The anti-inflammatory drug molecules include aspirin, ibuprofen or celecoxib;

[0030] The antibacterial drug molecules include penicillins, cephalosporins, aminoglycosides or macrolide antibiotic molecules.

[0031] The beneficial effects of the utility model are as follows:

[0032] In response to the technical problems existing in the prior art, the present invention provides a biodegradable sternum fixation device. By designing the outer shell of the fixing clamp into a three-layer structure that can be released in sequence, a drug polymer formed by blending drug molecules and degradable materials sequentially supports each layer of the structure. Over time, the outer shell degrades from the outside to the inside, releasing the drugs required for different wound healing stages, assisting wound healing, reducing the risk of infection of the incision, and reducing the incidence of complications. The belt body and the fixing clamp are all made of biodegradable materials, which can be naturally decomposed in the human body, eliminating the need for secondary surgery to remove them, and avoiding the risks brought by secondary surgery. It has the advantages of strong practicality, low risk, and the ability to promote wound healing in patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The specific implementation of the present invention will be further described in detail below with reference to the accompanying drawings.

[0034] Figure 1 One of the structural schematic diagrams of the sternum fixation device provided by an embodiment of the present utility model is shown.

[0035] Figure 2 The second structural schematic diagram of the sternum fixation device provided by the embodiment of the present utility model is shown.

[0036] Figure 3 A top view of a fixing clamp provided by an embodiment of the present utility model is shown.

[0037] Figure 4 The figure shows a structural diagram of the belt body provided by the embodiment of the utility model when passing through the fixed clamping head.

[0038] Figure 5 Show Figure 1 Schematic diagram of the structure of the middle tooth block and the spring block being engaged.

[0039] Figure 6 Show Figure 2 Schematic diagram of the structure of the middle tooth block and the spring block being engaged.

[0040] Figure 7 One of the top views of the sternum fixation device provided by an embodiment of the present utility model is shown.

[0041] Figure 8 FIG2 shows a second top view of the sternum fixation device provided by an embodiment of the present invention.

[0042] Figure 9 A cross-sectional view of a fixing clamp provided by an embodiment of the present utility model is shown. DETAILED DESCRIPTION

[0043] The present invention will be further described in detail below with reference to the accompanying drawings and examples. It should be understood that the specific embodiments described herein are intended only to illustrate the present invention and are not intended to limit the present invention. It should also be noted that, for ease of description, the accompanying drawings only illustrate portions relevant to the present invention, not all of its components.

[0044] In the description of this utility model, unless otherwise specified or limited, the terms "connected," "connected," and "fixed" should be understood in a broad sense. For example, they can refer to fixed connection, detachable connection, or integration; they can refer to direct connection or indirect connection through an intermediate medium; they can refer to internal communication between two components or interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this utility model based on the specific circumstances.

[0045] In the present invention, unless otherwise clearly stipulated and limited, the first feature being "above" or "below" the second feature may include the first and second features being in direct contact, or the first and second features not being in direct contact but being in contact through another feature between them.

[0046] In the description of this embodiment, terms such as "upper," "lower," "left," and "right" are used to refer to positions or locations based on the positions or locations shown in the accompanying drawings. These terms are intended solely to facilitate description and simplify operation, and are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations on this invention. Furthermore, the terms "first" and "second" are used solely for descriptive purposes and have no special meaning.

[0047] When stainless steel wire is used to fix the sternum, contact with the patient's underlying tissue often causes poor wound healing. Furthermore, as a foreign body, the wire requires a second surgery to remove after the sternum has healed. Scar tissue forms during bone healing after the initial surgery, and this dense scar tissue increases the difficulty of wire removal. This can result in prolonged surgery and the need for more delicate manipulation to avoid damage to surrounding tissue. Furthermore, a second surgery may involve more incisions and procedures, as well as the presence of scar tissue, which can increase the risk of infection and exacerbate the patient's suffering.

[0048] In view of the defects of the prior art, the utility model provides a biodegradable sternum fixation device, combined with Figure 1-9 As shown, the sternum fixation device includes a belt body 1 and a tip structure 2 and a fixing clamp 3 respectively located at two ends of the belt body 1.

[0049] The belt body 1 is used for being tied around the human skeleton and is fastened and fixed by a fixing clamp 3. One side surface of the belt body 1 comprises a plurality of evenly distributed tooth blocks 11, and the other side surface of the belt body 1 is a smooth surface.

[0050] The fixing clamp 3 includes a shell 31 in a circular shape and an elastic block 32 provided on the inner wall of the shell 31. The elastic block 32 and the tooth block 11 correspond in structure to tighten and fix the belt body 1 to prevent the belt body 1 from loosening.

[0051] The two ends of the shell 31 are respectively the entrance end A and the exit end B for the tip structure 2 to drive the belt body 1 to pass in and out. The belt body 1 enters from the entrance end A along with the tip structure 2, and squeezes the spring block 32 under the action of external force to pass out from the exit end B. After pulling the fixed clamp 3 to the appropriate position of the belt body 1, the external force is removed, the spring block 32 is reset, and abuts against the corresponding tooth block 11 to limit the belt body 1, preventing the belt body 1 from slipping out of the fixed clamp 3, thereby playing a role in fixing the sternum and assisting healing.

[0052] like Figure 3 and Figure 9 As shown, the outer shell 31 includes a third release layer 313, a second release layer 312, and a first release layer 311, which are stacked in sequence from the inside out. The first release layer 311 is located on the outermost side of the outer shell 31 and is the first to come into contact with the human body. The first release layer 311, the second release layer 312, and the third release layer 313 are all made of biodegradable materials and are capable of degrading in the human body in the order of the first release layer 311, the second release layer 312, and the third release layer 313.

[0053] The first release layer 311 is a drug polymer formed by a blend of anti-inflammatory drug molecules, antibacterial drug molecules and degradable materials. It is located in the outermost layer and degrades first. During the degradation process, it releases anti-inflammatory drug molecules and antibacterial drug molecules, which can relieve the patient's early postoperative wound pain and redness and swelling symptoms, prevent inflammation, reduce the risk of infection, and reduce the incidence of complications.

[0054] The second release layer 312 is a drug polymer formed by blending wound-healing drug molecules, antibacterial drug molecules and degradable materials, and is located in the middle layer. After the first release layer 311 degrades, the second release layer 312 begins to degrade. The wound-healing drug molecules released during the degradation process can promote the healing speed of the patient's skin wounds. The antibacterial drug molecules released during the degradation process can reduce the risk of infection of the incision and reduce the incidence of complications.

[0055] The third release layer 313 is a drug polymer formed by a blend of bone healing promoting drug molecules, antibacterial drug molecules and degradable materials, and is located in the innermost layer. After the second release layer 312 degrades, the third release layer 313 begins to degrade. The bone healing promoting drug molecules released during the degradation process can promote sternal healing, and the antibacterial drug molecules released during the degradation process can reduce the risk of infection of the incision and reduce the incidence of complications.

[0056] The drug molecules contained in the first release layer 311, the second release layer 312, and the third release layer 313, combined with their sequential release, can meet the drug needs of the sternal incision at different healing stages, thereby preventing impaired wound healing. Furthermore, the sternal fixation device is made of a fully biodegradable material and can completely degrade within the body within 12 months, eliminating the need for secondary surgical removal and the associated risks.

[0057] In a specific embodiment, the spring block 32 includes a connecting portion 321 formed by a protrusion on the inner wall of the housing 31, and a contact portion 322 formed by the end of the connecting portion 321 extending toward the outlet end B. The surface of the contact portion 322 includes teeth 3220 corresponding to the tooth block 11. The tooth block 11 engages with the teeth 3220 to limit the position of the belt body 1 within the fixed clamp 3.

[0058] In this embodiment, the elastic block 32 divides the inner cavity of the housing 31 into an adjustment cavity 314 and a connecting cavity 315. The contact portion 322 can be moved from the connecting cavity 315 to the adjustment cavity 314 by an external force, so that the belt body 1 can pass through the connecting cavity 315 smoothly.

[0059] Adjustment cavity 314 is the portion between contact portion 322 and the inner wall where elastic block 32 is located. Contact portion 322 and the inner wall are connected only by connection portion 321. Connecting cavity 315 is the portion between elastic block 32 and the inner wall opposite to where it is located. Connecting cavity 315 is connected to inlet port A and outlet port B.

[0060] The teeth 3220 are protruding from the surface of the contact portion 322 and are located in the connecting cavity 315. Figure 5-6 As shown, it is used to engage with the tooth block 11 to limit the belt body 1.

[0061] The material used for the elastic block 32 is a biodegradable material with a high elastic modulus. When the belt body 1 enters the connecting cavity 315 from the inlet end A, due to the arrangement of the teeth 3220, the channel width of the connecting cavity 315 corresponding to the teeth 3220 is smaller than the thickness of the portion of the belt body 1 with the tooth block 11. Therefore, in order to allow the belt body 1 to pass smoothly through the outlet end B, as shown in FIG. Figure 4 As shown, the external force applied during connection causes the inclined surface of the tooth block 11 to interact with the inclined surface of the tooth 3220 to push the contact portion 322 toward the adjustment cavity 314 (as shown in FIG. Figure 4 When the belt body 1 is tightened to a suitable position, the external force is removed and the contact portion 322 is automatically reset. At this time, the teeth 3220 are clamped with the corresponding tooth block 11 to prevent the belt body 1 from loosening.

[0062] In one embodiment, Figure 7 As shown, the tip structure 2 is formed by gradually converging one end of the belt body 1 away from the fixing clamp 3 and is in the shape of a sharp needle, which is used to pass through the muscle tissue on both sides of the sternum so that the belt body 1 can wrap around the sternum to tie the sternum.

[0063] In another embodiment, Figure 8 As shown, the tip structure 2 is a stainless steel needle, fixed to the end of the belt body 1 away from the fixed clamp 3. The stainless steel needle has moderate rigidity, ensuring smooth and unobstructed penetration of muscle tissue, preventing bending or breakage, and improving the success rate and safety of the insertion. Furthermore, the smooth surface of the needle reduces friction and damage to muscle tissue during penetration, thereby alleviating pain for the patient.

[0064] During actual use, after using the tip structure 2 to pass through the muscle tissue on both sides of the sternum, the belt body 1 is fixed and tied to the sternum with the fixing clamp 3, and then the excess parts of the tip structure 2 and the belt body 1 are cut off, and finally sutured. This sternum fixation device will gradually decompose in the human body over time and does not require a second operation to remove it.

[0065] In one embodiment, Figure 1 As shown, the side of the belt body 1 with the tooth block 11 includes a recessed slot 12 , and the tooth block 11 is formed in the slot 12 .

[0066] In another embodiment, Figure 2 As shown, the tooth block 11 is arranged to protrude from the surface on which it is located.

[0067] In a specific embodiment, the belt body 1 and the fixing clamp 3 are both made of biodegradable materials, and the tip structure 2 can be made of either biodegradable material or stainless steel, depending on actual needs.

[0068] First release layer 311 is a drug polymer blended with anti-inflammatory and antibacterial drug molecules and a degradable material. It is located in the outermost layer and degrades first. Second release layer 312 is a drug polymer blended with wound healing drug molecules and antibacterial drug molecules and a degradable material. It is located in the middle layer and begins to degrade after first release layer 311 degrades. Third release layer 313 is a drug polymer blended with bone healing drug molecules and antibacterial drug molecules and a degradable material. It is located in the innermost layer and begins to degrade after second release layer 312 degrades.

[0069] In this embodiment, the biodegradable material can be polylactic acid or polycaprolactone. Polylactic acid is a green polymer material made from grains. It has excellent biocompatibility and natural degradability. It can be degraded into carbon dioxide and water by natural microorganisms, and is therefore widely used in the medical field. Polycaprolactone is a high molecular polymer with good biodegradability. Polycaprolactone has better elasticity and toughness than polylactic acid, making it suitable for applications with higher elasticity requirements.

[0070] In one embodiment, the bone healing promoting drug molecules include teripatide, etc.; the wound healing promoting drug molecules include recombinant human epidermal growth factor, etc.; the anti-inflammatory drug molecules include aspirin, ibuprofen or celecoxib, etc., and one or more anti-inflammatory drug molecules can be selected; the antibacterial drug molecules include one or more of penicillin, cephalosporin, aminoglycoside or macrolide antibiotic molecules.

[0071] The biodegradable sternum fixation device provided by the embodiment of the present invention is designed to have a three-layer structure with a fixed clamp head that can be released in sequence. The drug polymer formed by blending drug molecules and degradable materials supports each layer of the structure in sequence. As time goes by, the outer shell degrades from the outside to the inside, releasing the drugs required for different wound healing stages, assisting wound healing, reducing the risk of infection of the incision, and reducing the incidence of complications. The belt body and the fixed clamp head are all made of biodegradable materials, which can be naturally decomposed in the human body, and do not require secondary surgery to remove, thus avoiding the risks brought by secondary surgery. It has the advantages of strong practicality, low risk, and the ability to promote wound healing in patients.

[0072] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not limitations on the implementation methods of the present invention. For ordinary technicians in the relevant field, other different forms of changes or modifications can be made based on the above description. It is impossible to list all the implementation methods here. All obvious changes or modifications derived from the technical solution of the present invention are still within the scope of protection of the present invention.

Claims

1. A biodegradable sternum fixation device, characterized in that: include: A belt body and a tip structure and a fixing clamp respectively located at two ends of the belt body; One side surface of the belt body includes a plurality of evenly distributed tooth blocks, and the other side surface of the belt body is a smooth surface; The fixed clamp includes a shell with a circular structure and a spring block provided on the inner wall of the shell, wherein the spring block and the tooth block are structured to correspond to each other; The two ends of the shell are respectively an inlet end and an outlet end for the tip structure to drive the belt body to pass in and out; The shell includes a third release layer, a second release layer and a first release layer stacked in sequence from the inside to the outside, the third release layer includes bone healing promoting drug molecules and antibacterial drug molecules, the second release layer includes wound healing promoting drug molecules and antibacterial drug molecules, and the first release layer includes anti-inflammatory drug molecules and antibacterial drug molecules.

2. The biodegradable sternum fixation device according to claim 1, characterized in that: The bullet block includes a connecting portion formed by a protrusion on the inner wall of the shell, and a contact portion formed by an end portion of the connecting portion extending toward the outlet end; The surface of the contact portion includes teeth correspondingly matched with the tooth block.

3. The biodegradable sternum fixation device according to claim 2, characterized in that: The elastic block divides the inner cavity of the shell into an adjustment cavity and a connection cavity; The adjustment cavity is the portion between the contact portion and the inner wall where the elastic block is located; The connecting cavity is the portion between the bullet block and the inner wall opposite to the inner wall where it is located, and the connecting cavity is connected to the inlet end and the outlet end; The teeth are arranged to protrude from the surface of the contact portion and are located in the connecting cavity.

4. The biodegradable sternum fixation device according to claim 1, characterized in that: The tip structure is formed by gradually contracting one end of the belt body away from the fixing clamp.

5. The biodegradable sternum fixation device according to claim 1, characterized in that: The tip structure is a steel needle, which is fixed to an end of the belt body away from the fixed clamp.

6. The biodegradable sternum fixation device according to claim 1, characterized in that: The side of the belt body with the tooth block comprises a recessed slot, and the tooth block is formed in the slot.

7. The biodegradable sternum fixation device according to claim 1, characterized in that: The tooth blocks are arranged to protrude from the surface where they are located.

8. The biodegradable sternum fixation device according to claim 1, characterized in that: The belt body and the fixing clamp are both made of biodegradable materials.

9. The biodegradable sternum fixation device according to claim 8, characterized in that: The biodegradable material is polylactic acid material or polycaprolactone material.

10. The biodegradable sternum fixation device according to claim 1, characterized in that: The bone healing promoting drug molecules include teripatate; The wound healing promoting drug molecules include recombinant human epidermal growth factor; The anti-inflammatory drug molecules include aspirin, ibuprofen or celecoxib; The antibacterial drug molecules include penicillins, cephalosporins, aminoglycosides or macrolide antibiotic molecules.

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