Artificial prosthesis

Abstract

The invention discloses an artificial prosthesis. The artificial prosthesis is a sheet-shaped, tubular, spherical or other irregular-shaped prosthesis which is formed by sewing; the artificial prosthesis is formed at the sewing position in a one-time sewing mode through the sewing thread in a double-thread mode, and the needle hole is filled with the sewing thread, so that body fluid cannot leak from the side with the high pressure to the side with the low pressure through the needle hole. Compared with the prior art, the prosthesis is prepared in a sewing forming mode, the sewing lines can be used for filling the needle holes in the sewing mode, the needle holes can be effectively blocked by the sewing lines filled in the needle holes, and the problem that body fluid is prone to leaking through the needle holes at the sewing position is well solved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical products, and in particular to an artificial prosthesis. Background Art

[0002] During the sewing operation of medical products, the size of the needle holes formed on the material during the sewing operation is often larger than the diameter of the suture, resulting in body fluid leakage through the needle holes at the suture position during the use of the medical product. This makes it difficult for such medical products that need to be sewn to meet application requirements in scenarios with high requirements for leakage performance. Summary of the Invention

[0003] The object of the present invention is to provide an artificial prosthesis to solve the problem that the artificial prosthesis formed by sewing is prone to leakage of body fluids at the suture connection position.

[0004] The present invention is achieved through the following technical solutions: Artificial prosthesis, wherein the artificial prosthesis is a sheet-shaped, tubular, spherical or other irregularly shaped prosthesis obtained by sewing; The artificial prosthesis is sewn into shape at one time using double-thread sutures at the sewing position, and the sutures fill each needle hole so that body fluids will not leak from the side with higher pressure to the side with lower pressure through the needle holes.

[0005] In some embodiments, the artificial prosthesis is a stent graft, an artificial blood vessel, an artificial valve, or a patch.

[0006] In some embodiments, the artificial prosthesis is a structure having a cavity obtained by sewing, and a continuous transition structure is formed in the cavity at the sewing position.

[0007] In some embodiments, the artificial prosthesis is a tubular structure obtained by curling a sheet material, butting two free ends together to form a stacked arrangement to form a suture edge protruding outward, and then sewing the suture edge.

[0008] On the other hand, the present invention also provides another artificial prosthesis, which is a sheet-shaped, tubular, spherical or other irregularly shaped prosthesis obtained by sewing. The artificial prosthesis is formed by multiple sewing at the sewing position, and double-line sutures are used during the last sewing, so that each needle hole is filled with at least three sutures. By filling the needle holes with sutures, body fluids will not leak through the needle holes from the side with higher pressure to the side with lower pressure.

[0009] In some embodiments, the cross-sectional area of ​​the double-thread suture used in the last sewing is not less than the cross-sectional area of ​​the suture used in other sewing times.

[0010] In some embodiments, the artificial prosthesis is formed by sewing twice at the sewing position, the first sewing uses single-line or double-line sutures, and the second sewing uses double-line sutures, and during the second sewing, the sutures are passed through the needle holes formed at each sewing point during the first sewing.

[0011] Compared with the prior art, the present invention has the following advantages and beneficial effects: The present invention adopts a sewing molding method to prepare the prosthesis. The sewing method adopted can use sutures to fill each needle hole, so that the sutures filled in the needle holes can effectively block the needle holes, which well solves the problem of body fluids easily leaking through the needle holes at the sewing positions.

[0012] In sewing-molded prostheses, to achieve a continuous inner wall, the prosthetic materials are stacked at the suture location to form a suture edge for suture connection. The suture edge is then sewn together with thread. The resulting inner wall of the prosthesis forms a continuous transition structure at the suture location, resulting in a streamlined inner wall that facilitates the flow of internal body fluids. This structure better meets the actual needs of prostheses and is of great significance in reducing resistance to fluid flow and improving prosthesis performance. Furthermore, the outwardly protruding suture edge facilitates multiple sewing operations.

[0013] Artificial prostheses typically employing suture structures, particularly those with a cavity structure, are subject to pressure from internal body fluids, which in turn causes the cavity to expand outward, potentially causing the prosthesis to tear open at the suture location, exposing the pinhole into the cavity and potentially allowing body fluids within the prosthesis to leak through the pinhole. The suture structure employed in the prosthesis of the present invention utilizes sutures to seal the pinhole. Even if the sutures tear open, exposing the pinhole into the prosthesis, leakage at the pinhole location is prevented. Furthermore, the use of double sutures or multiple sutures increases the strength of the connection structure at the suture location.

[0014] The present invention starts stitching from different sides in multiple sewing operations, and makes the sewing threads pass through the same needle holes. The sewing threads of each sewing are relatively symmetrically arranged on both sides of the sewing edge, which can generate relatively inward forces on both sides of the sewing edge, realize stable and reliable connection at the sewing position, and further ensure the quality of sewing.

[0015] The sewing method of the present invention is applicable to the sewing connection of single-layer, double-layer or multi-layer artificial prosthesis materials, and can be used for the preparation of artificial prostheses such as stent grafts, artificial blood vessels, artificial valves, patches, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings in the embodiments will be briefly introduced below. It should be understood that the following drawings only illustrate certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other relevant drawings can be obtained based on these drawings without paying any creative work.

[0017] Figure 1 Schematic diagram of the structure of a single-line suture in an embodiment of the present invention.

[0018] Figure 2 Schematic diagram of the structure of a double-line suture in an embodiment of the present invention.

[0019] Figure 3 Schematic diagram of the structure of an artificial prosthesis according to an embodiment of the present invention.

[0020] Figure 4 for Figure 3 Schematic diagram of the cross section of the artificial prosthesis.

[0021] Figure 5 This is a schematic cross-sectional view of an artificial prosthesis with an overlapping structure at the suture position.

[0022] Figure 6 In the embodiment of the present invention, the two layers of artificial prosthesis material are sewn into a structure formed by sewing with double threads at one time.

[0023] Figure 7 In the embodiment of the present invention, the three-layer artificial prosthesis material is sewn into a structure formed by sewing with double threads in one go.

[0024] Figure 8 This is a sewing structure that adopts two-time sewing forming in the embodiment of the present invention.

[0025] in: 10. Suture, 11. First suture, 12. Second suture; 20. Pinhole; 30. Artificial prosthesis, 301. Suture edge. DETAILED DESCRIPTION

[0026] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments.

[0027] During the sewing process of an artificial prosthesis, the size of the needle hole formed on the artificial prosthesis is often larger than the size of the needle hole in the suture, resulting in body fluids easily leaking through the needle hole under the action of pressure during the use of the artificial prosthesis.

[0028] To address this problem, the present invention improves the sewing structure formed by sewing the artificial prosthesis, and utilizes the sewing structure formed on the artificial prosthesis during sewing to effectively solve the problem of body fluid leakage at the sewing position.

[0029] In some embodiments, the artificial prosthesis 30 is a sheet-shaped, tubular, spherical or other irregularly shaped prosthesis obtained by sewing, such as a coated stent, an artificial blood vessel, an artificial valve, a patch, etc. Of course, it is not limited to the prosthetic products listed above. Other prostheses that need to be prepared by sewing and need to avoid body fluid penetration during actual use are all artificial prostheses referred to in the present invention.

[0030] The artificial prosthesis is sewn into shape by using double-line sutures 10 at the sewing position to sew it into shape once, and the needle holes 20 formed by sewing are filled with sutures so that body fluids will not leak from the side with higher pressure to the side with lower pressure through the needle holes.

[0031] Reference Figure 1 For single-thread sutures, a single thread is used for sewing connections, and a single thread is also left in the needle hole; Figure 2 In order to use double-thread sutures, the suture is usually passed through the eye of the needle so that the beginning and end of the suture are equal in length. The sewing connection is equivalent to using two threads, and there are also two threads left in the needle hole.

[0032] Obviously, when sewing with double-thread sutures, the cross-sectional area of ​​the sutures is larger than that of the single-thread sutures. At this time, the two threads filled in the needle hole can effectively block the needle hole to solve the problem of needle hole leakage.

[0033] For example, artificial prostheses with a cavity structure, such as artificial blood vessels, provide space for blood to flow. To ensure smooth blood flow in the prosthesis, the inner wall of the prosthesis usually needs to be well streamlined, that is, have a smooth or continuously transitioned inner wall. However, when suturing an artificial prosthesis, the inner wall of the prosthesis is prone to forming a step-like structure at the suture position when the traditional lap suture method is used because the materials need to be sutured and connected. Figure 5 As shown, the inner wall of the artificial prosthesis prepared at this time will present a discontinuous surface at the suture position, which affects the normal flow of internal body fluids and the performance of the artificial prosthesis.

[0034] Therefore, some embodiments of the present invention provide an artificial prosthesis having a cavity structure obtained by sewing, and a continuous transition structure is formed at the suture position in the cavity. The artificial prosthesis with this structure can well solve the problems existing in the above-mentioned cavity with a discontinuous surface.

[0035] In some embodiments of the present invention, in order to obtain a cavity having a connection transition structure at the suture position, referring to Figure 3 and Figure 4 After curling the sheet material, the two free ends are aligned and connected to form a stacked arrangement to form a sewing edge 301 protruding outward, and then the sewing edge 301 is sewn to perform a sewing connection.

[0036] Taking the formation of artificial blood vessels as an example, after curling a sheet of artificial prosthesis material, the two free ends of the sheet material are butted together to form a stacked structure, thereby obtaining a suture edge with an outward protrusion. The suture edge is then sutured to obtain an artificial blood vessel, and the interior of the artificial blood vessel can present a continuous transition surface at the suture position. Figure 4 The cross section of the artificial blood vessel cavity is teardrop-shaped. Figure 5 As shown in the figure, a stepped structure is formed inside the cavity by overlapping, and the cavity with a teardrop-shaped cross-section is a structure with a continuous transition.

[0037] The cavity of the artificial prosthesis of the present invention can present a continuous transition structure at the suture position, and this structure has obvious advantages in the practical application of artificial blood vessels.

[0038] The sewing method of the artificial prosthesis of the present invention can be used for sewing and connecting single-layer, double-layer or multi-layer artificial prostheses. Figure 6 This is a schematic diagram of a sewing structure for sewing a pair of butt-jointed suture edges or two stacked layers of artificial prosthesis materials using a double-thread suture 10. Figure 7 This diagram illustrates the sewing structure of three stacked layers of prosthetic material using double-thread sutures 10. The prosthesis 30 can be formed by sewing marking lines onto the prosthetic material or prosthesis to create a prosthesis with marking lines. Alternatively, two pieces of prosthetic material can be butted together at their ends, or a single piece of prosthetic material can be wound and then butted together with its two free ends aligned. For example, two pieces of prosthetic material can be butted together at one end and then sewn together to form a patch, or a single piece of prosthetic material can be butted together at both ends and then sewn together to form a tubular artificial blood vessel.

[0039] In some embodiments, the artificial prosthesis is formed by multiple sewing at the sewing position, and double-line sutures 10 are used during the last sewing, so that each needle hole 20 is filled with at least three sutures. By filling the needle holes with sutures, body fluids will not leak through the needle holes from the side with higher pressure to the side with lower pressure.

[0040] The artificial prosthesis 30 in this embodiment can be a stent graft, an artificial blood vessel, an artificial valve, or a patch.

[0041] In some embodiments, the cross-sectional area of ​​the double-thread suture used in the last sewing is not less than the cross-sectional area of ​​the suture used in the other sewing times. During the last sewing, the double-thread suture is used to fill the remaining space in the needle hole, thereby sealing the needle hole.

[0042] In some embodiments, taking sewing twice at the sewing position as an example, the sewing edge is sewn for the first time along the sewing direction using a single-line or double-line suture, and then the sewing edge is sewn for the second time along the sewing direction using a double-line suture. When sewing for the second time, the second suture is passed through the needle holes formed at each sewing point during the first sewing in sequence.

[0043] Take the above two sewing as an example, refer to Figure 8 The first sewing uses a single-thread first suture 11, and the second sewing uses a double-thread second suture 12. The sewing edges are preliminarily connected through the first sewing. After the first sewing, a single suture is filled into the needle hole. In this way, when the second sewing is performed, when the needle passes through the original needle hole again, the amount of expansion of the original needle hole will be very small. At this time, a double-thread suture is used for the second sewing. The double-thread second suture can effectively fill the needle hole to fill the remaining space in the needle hole. After the two sewings, the needle hole is sealed with three sutures. The specifications of the three sutures are larger than the size of the needle hole formed by the suture needle, which can effectively solve the problem of body fluid leakage through the needle hole.

[0044] Likewise, when sewing is performed twice using a first double-thread suture and a second double-thread suture, four sutures are simultaneously filled in each needle hole, and the needle holes are blocked by the four sutures.

[0045] The first suture can be a suture with a smaller diameter, and the second suture can be a suture with a larger diameter, so that the diameter of the suture during the second sewing is larger than the diameter of the suture during the first sewing.

[0046] The suture used for sewing can be any material that can be used for sewing artificial prostheses, such as polyester, which has good water absorption and expansion properties and can achieve better results in sealing needle holes and preventing leakage in application.

[0047] During the first sewing and the second sewing, the stitches can be alternately sewn up and down in sequence, such as in a serpentine pattern. This is also a commonly used method in sewing operations.

[0048] In some embodiments, reference Figure 8 The first and second sutures 11, 12 are sewn from different sides of the prosthesis, so that the first and second sutures 11, 12 are symmetrically arranged on both sides of the suture edge. At this time, the first and second sutures between each two sewing points are located on both sides of the prosthesis. The first and second sutures exert forces in opposite directions on the suture edge at the suture position, which can achieve a better suture connection effect.

[0049] In some embodiments, the artificial prosthesis can be made of either biological or artificial materials. Biological materials can be natural or modified natural materials, such as decellularized collagen matrix materials, or thin sheets of human or animal pericardium, such as bovine pericardium. Artificial materials can be woven fabrics made of fibers or silicone products. When sewing these materials, the sewing structures described in the above embodiments are highly effective in preventing bodily fluid leakage through the needle holes.

[0050] In the description of the present invention, it should be noted that the terms "center", "up", "down", "left", "right", "vertical", "horizontal", "inside", "outside", etc. used to indicate the orientation or position relationship are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the invention is usually placed when in use. They are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation. Therefore, they should not be understood as limiting the present invention.

[0051] Furthermore, the use of terms such as "horizontal" and "vertical" in the description of the present invention does not necessarily imply that the component must be absolutely horizontal or suspended, but rather that it can be slightly tilted. For example, "horizontal" simply means that its direction is more horizontal than "vertical" and does not mean that the structure must be completely horizontal, but rather that it can be slightly tilted.

[0052] It should also be noted that, in the description of the present invention, unless otherwise expressly specified or limited, the terms "disposed," "installed," "connected," and "connected" should be understood in a broad sense. For example, they may refer to fixed connections, detachable connections, or integral connections; mechanical connections or electrical connections; direct connections or indirect connections through an intermediate medium; and internal connections between two components. Those skilled in the art will understand the specific meanings of the above terms in the present invention in specific contexts.

[0053] The above description is only a preferred embodiment of the present invention and does not limit the present invention in any form. Any simple modification or equivalent change made to the above embodiment based on the technical essence of the present invention shall fall within the scope of protection of the present invention.

Claims

1. An artificial prosthesis, characterized in that: The artificial prosthesis is a prosthesis in sheet, tube, sphere or other irregular shapes obtained by sewing; The artificial prosthesis is formed by sewing at the sewing position in one time using double-thread sutures, and the needle hole is filled with sutures so that body fluid will not leak from the side with higher pressure to the side with lower pressure through the needle hole.

2. The artificial prosthesis according to claim 1, characterized in that: The artificial prosthesis is a covered stent, an artificial blood vessel, an artificial valve, or a patch.

3. The artificial prosthesis according to claim 1, characterized in that: The artificial prosthesis is a structure having a cavity obtained by sewing, and a continuous transition structure is formed in the cavity at the sewing position.

4. The artificial prosthesis according to claim 3, characterized in that: The artificial prosthesis is a tubular structure obtained by curling a sheet material and butting two free ends to form a stacked arrangement to form a suture edge protruding outward, and sewing the suture edge to form a tube structure.

5. An artificial prosthesis, characterized in that: The artificial prosthesis is a prosthesis in sheet, tube, sphere or other irregular shapes obtained by sewing; The artificial prosthesis is formed by multiple sewing at the sewing position, and double-thread sutures are used during the last sewing, so that each needle hole is filled with at least three sutures. The filling of the needle holes with sutures prevents body fluids from leaking through the needle holes from the side with higher pressure to the side with lower pressure.

6. The artificial prosthesis according to claim 5, characterized in that: The artificial prosthesis is a covered stent, an artificial blood vessel, an artificial valve, or a patch.

7. The artificial prosthesis according to claim 5, characterized in that: The artificial prosthesis is a structure having a cavity obtained by sewing, and a continuous transition structure is formed in the cavity at the sewing position.

8. The artificial prosthesis according to claim 7, characterized in that: The artificial prosthesis is a tubular structure obtained by curling a sheet material and butting two free ends to form a stacked arrangement to form a suture edge protruding outward, and then sewing the suture edge.

9. The artificial prosthesis according to claim 5, characterized in that: The cross-sectional area of ​​the double-thread suture used in the last sewing is not less than the cross-sectional area of ​​the suture used in other sewing times.

10. The artificial prosthesis according to claim 5 or 9, characterized in that: The artificial prosthesis is sewn twice at the sewing position, the first sewing uses single-thread or double-thread sutures, the second sewing uses double-thread sutures, and during the second sewing, the sutures are sequentially passed through the needle holes formed at each sewing point during the first sewing.

11. The artificial prosthesis according to claim 10, characterized in that: The first sewing and the second sewing are respectively started from different sides of the artificial prosthesis, so that the sutures of the first sewing and the second sewing are relatively symmetrically arranged on both sides of the artificial prosthesis.

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