Tubular tissue anastomat

By using decomposed polylactic acid materials and chromium-containing iron-based materials, the rejection reaction and vascular stiffness caused by plastic rings after vascular anastomosis in the prior art is solved, and the decomposition and degradation of the stapler in the human environment is achieved, and the normal function and growth of the blood vessels are promoted.

CN119498911APending Publication Date: 2025-02-25YISHENG TECH (TIANJIN) CO LTD
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Patent Information

Application Number
CN202311058568.4
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2023-08-22
Publication Date
2025-02-25

AI Technical Summary

Technical Problem

After the existing vascular stapler is anastomotic, the plastic ring is permanently placed on the outer wall of the blood vessel, resulting in body rejection reactions, vascular stiffness and growth restriction.

Method used

A lumen tissue stapler is designed with an anastomosis ring made of decomposed polylactic acid material, anastomosis staples are made of iron-based material containing chromium, and covered with antioxidant structures on the surface of the anastomosis to decompose and degrade in a human environment.

Benefits of technology

The decomposition and degradation of anastomosis rings and anastomosis pins in the human environment are achieved, rejection reactions and vascular stiffness are avoided, and the normal function and growth of blood vessels are promoted.

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Abstract

The invention provides a lumen tissue anastomat which comprises an anastomosis ring and an anastomosis structure arranged on the anastomosis ring and used for fixing lumen tissue, and the anastomosis structure comprises an anastomosis nail. The anastomosis ring is made of a first material, and the anastomosis nail is made of a second material. In a human body environment, the first material can be decomposed to form a first substance, and the first substance reacts with the second material to degrade the second material. According to the mode, the anastomosis ring made of the first material can be decomposed in a human body environment, and the decomposed product can react with the anastomosis nail made of the second material, so that the anastomosis nail can be degraded more quickly; and meanwhile, the first material has a relatively low decomposition rate in the human body, so that the situation that the first material is decomposed too quickly before the lumen tissue is healed can be avoided.
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Description

Technical Field

[0001] The present invention generally relates to the technical field of vascular anastomosis devices, and in particular to a luminal tissue anastomosis device. Background Art

[0002] Vascular anastomosis technology began more than a hundred years ago, using manual suturing to perform vascular transplantation and limb replantation. After more than a hundred years of development, this technology has been widely used in various surgical operations. At present, vascular anastomosis has developed five major types of anastomosis technologies, including: vascular suture anastomosis technology, vascular bonding anastomosis technology, vascular bonding anastomosis technology, vascular laser anastomosis technology and vascular high-frequency electrocoagulation anastomosis technology.

[0003] At present, the most commonly used vascular anastomosis surgery in clinical practice is the needle ring method. Two small plastic rings are used, each with 6 small needles and 6 small holes evenly spaced. During the anastomosis, the broken end of one side of the blood vessel passes through the small holes, turned outward 90 degrees and fixed on the 6 small needles; the other end of the blood vessel is operated in the same way, and then the needles and holes of the two needle rings are inserted into each other.

[0004] Its disadvantages include: after anastomosis, the plastic ring is permanently attached to the outer wall of the blood vessel, which not only causes the body's rejection reaction, but also causes blood vessel stiffness, affects the normal physiological function of blood vessel contraction and relaxation, and restricts blood vessel growth. Summary of the invention

[0005] In view of the above-mentioned defects or deficiencies in the prior art, it is desired to provide a luminal tissue stapler.

[0006] The present invention provides a luminal tissue stapler, comprising:

[0007] An anastomotic ring and an anastomotic structure disposed on the anastomotic ring for fixing the luminal tissue, wherein the anastomotic structure comprises an anastomotic staple;

[0008] The anastomotic ring is made of a first material, and the anastomotic staple is made of a second material; the first material can be decomposed to form a first substance in a human body environment, and the first substance reacts with the second material in a human body environment to degrade the second material.

[0009] According to the technical solution provided by the present invention, the second material is an iron-based material containing chromium, and the mass of chromium in the second material accounts for 0.01% to 14% of the total mass of the stapler; and the first substance is hydrogen ions.

[0010] According to the technical solution provided by the present invention, the first material is polylactic acid.

[0011] According to the technical solution provided by the present invention, an anti-oxidation structure is provided on the outer surface of the stapler to prevent the stapler from being corroded before being implanted into a human body.

[0012] According to the technical solution provided by the present invention, the antioxidant structure is a metal or a metal compound; the metal activity in the metal or metal oxide is higher than that of iron.

[0013] According to the technical solution provided by the present invention, the metal is at least one of potassium, calcium, sodium, magnesium or zinc.

[0014] According to the technical solution provided by the present invention, the anti-oxidation structure is ring-shaped and sleeved on the anastomotic staple.

[0015] According to the technical solution provided by the present invention, the anti-oxidation structure covers the entire outer surface of the stapler, so as to isolate the stapler from the air before being implanted into the human body.

[0016] According to the technical solution provided by the present invention, the anti-oxidation structure is made of biodegradable material and covers the entire outer surface of the stapler, so as to isolate the stapler from the air before implantation into the human body.

[0017] According to the technical solution provided by the present invention, the biodegradable material is polylactic acid.

[0018] The beneficial effects of the present invention are:

[0019] An anastomotic ring and an anastomotic structure for fixing luminal tissue disposed on the anastomotic ring, wherein the anastomotic structure includes an anastomotic staple. The anastomotic ring is made of a first material, and the anastomotic staple is made of a second material. In the human body environment, the first material can be decomposed to form a first substance, and the first substance reacts with the second material to degrade the second material. The above method can utilize the anastomotic ring made of the first material to decompose in the human body environment, and the decomposed product can react with the anastomotic staple made of the second material to achieve faster degradation of the anastomotic staple; at the same time, the first material has a lower decomposition rate in the human body, so it can avoid too fast decomposition before the luminal tissue heals. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] Other features, objects and advantages of the present invention will become more apparent from the detailed description of non-limiting embodiments made with reference to the following drawings:

[0021] Figure 1 A schematic diagram of the structure of a luminal tissue stapler provided by the present invention;

[0022] Figure 2 It is a schematic diagram of the structure after the luminal tissue stapler is connected to the luminal tissue;

[0023] Figure 3 It is a schematic diagram of the structure after the luminal tissue stapler drives the luminal tissue to be anastomosed;

[0024] Figure 4A schematic diagram of the structure of an anti-oxidation structure on an anastomotic staple in an embodiment;

[0025] Figure 5 A schematic diagram of the structure of an anti-oxidation structure on an anastomotic staple in another embodiment;

[0026] Figure 6 is a schematic diagram of the structure of the anastomosis;

[0027] Among them: 1. luminal tissue; 2. anastomotic ring; 3. anastomotic staple; 4. antioxidant structure; 5. anastomotic body. DETAILED DESCRIPTION

[0028] The present invention will be further described in detail below in conjunction with the accompanying drawings and embodiments. It is to be understood that the specific embodiments described herein are only used to explain the relevant invention, rather than to limit the invention. It should also be noted that, for ease of description, only the parts related to the invention are shown in the accompanying drawings.

[0029] It should be noted that, in the absence of conflict, the embodiments of the present invention and the features in the embodiments can be combined with each other. The present invention will be described in detail below with reference to the accompanying drawings and in combination with the embodiments.

[0030] Please refer to Figure 1 , which is a schematic structural diagram of a luminal tissue stapler provided by the present invention, comprising:

[0031] An anastomotic ring 2 and an anastomotic structure for fixing the luminal tissue arranged on the anastomotic ring 2, wherein the anastomotic structure comprises an anastomotic staple 3;

[0032] The anastomotic ring 2 is made of a first material, and the anastomotic staple 3 is made of a second material; the first material can be decomposed to form a first substance in the human body environment, and the first substance reacts with the second material in the human body environment to degrade the second material.

[0033] Specifically, the luminal tissue 1 may be a tissue organ with a tubular structure, such as blood vessels and intestines of the human body or other animals.

[0034] In some embodiments, the middle portion of the anastomotic ring 2 has a mounting through hole opened along a first direction; a plurality of connection holes are evenly opened in the circumference of the anastomotic ring 2; one end of the anastomotic ring 2 has an anastomotic surface; and the first direction is parallel to the extension direction of the luminal tissue 1.

[0035] The anastomotic staples 3 are provided in plurality and are all fixedly mounted on the anastomotic surface; the luminal tissue 1 passes through the mounting through hole from the side away from the anastomotic surface, and the side wall of the end of the luminal tissue 1 is pierced by the anastomotic staples 3, which are used to fix the luminal tissue 1 and the anastomotic staples 3.

[0036] When the two anastomotic rings 2 are spliced ​​together, the multiple anastomotic staples 3 on one anastomotic ring 2 are respectively inserted into the multiple connecting holes on the other anastomotic ring 2, and the anastomotic surfaces of the two anastomotic rings 2 are close to each other and a gap is formed between them, driving the disconnected luminal tissues 1 on both sides to anastomose with each other, that is, the end side walls of the luminal tissues 1 on both sides are in the gap and abut against each other to form a complete luminal tissue 1.

[0037] Specifically, the first material can be decomposed into a first substance in the human body environment, and the first substance reacts with the second material to degrade the second material. The above method can utilize the anastomotic ring made of the first material to decompose in the human body environment, and the decomposed product can react with the anastomotic staples made of the second material to achieve faster degradation of the anastomotic staples; at the same time, the first material has a lower decomposition rate in the human body, so it can avoid too fast decomposition before the luminal tissue heals.

[0038] In some embodiments, the second material is a pure iron material.

[0039] Furthermore, the second material is an iron-based material containing chromium, and the mass of chromium in the second material accounts for 0.01% to 14% of the total mass of the stapler 3, inclusive; and the first substance is hydrogen ions.

[0040] Since the mass proportion of chromium in the iron-chromium alloy exceeds 14%, the corrosion resistance of the alloy will be greatly improved, which will greatly reduce the degradation rate of the staple 3 in the human body. Therefore, in this embodiment, the staple 3 uses an iron-based material containing 0.01% to 14% chromium, which can not only improve its structural strength but also prevent chromium from preventing iron from being degraded. Since the total mass of the staple 3 is very small, usually only a dozen milligrams, 14% of its mass is only about one milligram, which is lower than the dose that is harmful to the human body.

[0041] Furthermore, the first material is polylactic acid.

[0042] Specifically, in the human body environment, polylactic acid will slowly decompose into lactic acid, and lactic acid will ionize and decompose into hydrogen ions in the human body environment. The hydrogen ions react with the iron atoms of the staples 3 to generate hydrogen and iron ions. The hydrogen evaporates into the atmosphere through the human skin, and the iron ions participate in metabolism with the body fluids of the human body. In this way, the effect of using polylactic acid to degrade iron-based staples can be achieved.

[0043] Specifically, a long period of time is usually required between the production of the stapler and its implantation into the human body. If the stapler is stored for too long, water vapor and oxygen in the air will gradually corrode the iron connecting needle.

[0044] The staples 3 on the stapler are usually very small. Once corrosion occurs, the connection strength of the staples 3 will be affected. In severe cases, the staples 3 will break and lose their connection function.

[0045] Furthermore, an anti-oxidation structure 4 is provided on the outer surface of the stapler 3 to prevent the stapler 3 from being corroded before being implanted into a human body.

[0046] Specifically, the anti-oxidation structure 4 can be in any shape as long as it is connected to the staple 3. In some embodiments, the anti-oxidation structure 4 is U-shaped and is clamped on the outer surface of the staple 3.

[0047] Furthermore, the antioxidant structure 4 is a metal or a metal compound; the metal activity of the metal or metal oxide is higher than that of iron. The metal compound can be a metal oxide or other compound containing such metal and capable of participating in human body reactions.

[0048] Furthermore, the metal is at least one of potassium, calcium, sodium, magnesium or zinc.

[0049] In some embodiments, the metal activity of potassium, calcium, sodium, magnesium or zinc is higher than that of iron. When reacting, the oxides will preferentially react with potassium, calcium, sodium, magnesium or zinc to achieve an antioxidant effect on iron-based materials.

[0050] At the same time, potassium, calcium, sodium, magnesium and zinc are all elements needed by the human body. After being oxidized, they can supplement the trace elements needed by the human body and are beneficial to human health.

[0051] Furthermore, the anti-oxidation structure 4 is annular and sleeved on the stapler 3 .

[0052] In some embodiments, the antioxidant structure 4 is sleeved on the middle part of the staple 3. After implantation into the human body, the antioxidant structure 4 made of potassium, calcium, sodium, magnesium or zinc will delay the time when the staple 3 starts to degrade, thereby preventing the staple 3 from being degraded and losing its connection function before the lumen tissue heals.

[0053] Furthermore, the anti-oxidation structure 4 covers the entire outer surface of the stapler 3 to isolate the stapler 3 from the air before implantation into the human body.

[0054] In some embodiments, the anti-oxidation structure 4 covers the entire surface of the staple 3, which can prevent oxygen and water vapor in the air from contacting the iron-based staple 3 before implantation into the human body, thereby preventing the staple 3 from being corroded in advance.

[0055] Furthermore, the anti-oxidation structure 4 is made of biodegradable material and covers the entire outer surface of the stapler 3 , so as to isolate the stapler 3 from the air before being implanted into the human body.

[0056] Furthermore, the biodegradable material is polylactic acid.

[0057] In some embodiments, polylactic acid is used to coat the entire surface of the stapler 3, which can not only isolate the stapler 3 from the air before implantation into the human body, but also directly react around the stapler 3 to generate hydrogen ions to accelerate degradation efficiency after implantation into the human body.

[0058] In some embodiments, reference Figure 6 The anastomotic ring 2 includes a plurality of anastomotic bodies 5, which can be moved along the radial direction of the anastomotic ring 2 to positions separated from each other and positions assembled with each other. The anastomotic bodies 5 in the assembled positions are assembled to form an annular structure.

[0059] The anastomotic staple 3 and the anastomotic ring 2 can be connected by various existing methods. In this embodiment, the anastomotic staple 3 and the anastomotic ring 2 are threadedly connected.

[0060] The anastomotic staples 3 and the connecting holes on the anastomotic ring 2 are spaced apart from each other and are evenly arranged along the circumference of the anastomotic ring 2. The anastomotic staples 3 are composed of an integrally formed staple head, a connecting section and a staple body, the staple head is a conical head, the diameter of the bottom of the staple head is larger than the inner diameter of the connecting hole, and the staple body forms an interference fit with the connecting hole.

[0061] The anastomotic ring 2 is made of biodegradable materials such as poly-α-hydroxy acid, polyglycolic acid, polyanhydride, polyorthoester, polyphosphazene, polydioxane, gelatin, chitin or hyaluronic acid.

[0062] The above description is only a preferred embodiment of the present invention and an explanation of the technical principles used. Those skilled in the art should understand that the scope of the invention involved in the present invention is not limited to the technical solution formed by a specific combination of the above technical features, but should also cover other technical solutions formed by any combination of the above technical features or their equivalent features without departing from the inventive concept. For example, the above features are replaced with the technical features with similar functions disclosed in the present invention (but not limited to) to form a technical solution.

Claims

1. A luminal tissue stapler, used for fixing and connecting luminal tissues (1) disconnected on both sides of a human body, characterized in that: include: An anastomotic ring (2) and an anastomotic structure arranged on the anastomotic ring (2) for fixing the luminal tissue, wherein the anastomotic structure comprises an anastomotic staple (3); The anastomotic ring (2) is made of a first material, and the anastomotic staple (3) is made of a second material; the first material can be decomposed in a human body environment to form a first substance, and the first substance reacts with the second material in a human body environment to degrade the second material.

2. The endoluminal tissue stapler according to claim 1, characterized in that: The second material is an iron-based material containing chromium, and the mass of chromium in the second material accounts for 0.01% to 14% of the total mass of the anastomotic staple (3); and the first substance is hydrogen ions.

3. The luminal tissue stapler according to claim 1, characterized in that: The first material is polylactic acid.

4. The luminal tissue stapler according to any one of claims 1 to 3, characterized in that: The outer surface of the anastomotic staple (3) is provided with an anti-oxidation structure (4) for preventing the anastomotic staple (3) from being corroded before being implanted into a human body.

5. The endoluminal tissue stapler according to claim 4, characterized in that: The anti-oxidation structure (4) is a metal or a metal compound; the metal activity in the metal or metal oxide is higher than that of iron.

6. The endoluminal tissue stapler according to claim 5, characterized in that: The metal is at least one of potassium, calcium, sodium, magnesium or zinc.

7. The endoluminal tissue stapler according to claim 5, characterized in that: The anti-oxidation structure (4) is ring-shaped and sleeved on the anastomotic staple (3).

8. The endoluminal tissue stapler according to claim 5, characterized in that: The anti-oxidation structure (4) covers the entire outer surface of the anastomotic staple (3) and is used to isolate the anastomotic staple (3) from the air before implantation into the human body.

9. The luminal tissue stapler according to claim 4, characterized in that: The anti-oxidation structure (4) is made of biodegradable material and covers the entire outer surface of the anastomotic staple (3), and is used to isolate the anastomotic staple (3) from the air before implantation into the human body.

10. The endoluminal tissue stapler according to claim 9, characterized in that: The biodegradable material is polylactic acid.