Artificial branched blood vessel and its preparation method

Abstract

The present invention relates to the field of medical materials, and more particularly, to an artificial branched blood vessel and a preparation method thereof. The artificial branched blood vessel includes a main blood vessel and a branched blood vessel. A window is formed on the wall of the main blood vessel, and the branched blood vessel is located at the window and connected to the main blood vessel. The branched blood vessel includes a branched main body and a connecting portion located at one end of the branched main body. At the window, the inner wall of the connecting portion is attached to the inner wall of the main blood vessel to form a joint portion, and a first loop suture is formed on the joint portion by a first suture thread.

Description

Technical Field

[0001] The present invention relates to the field of medical materials, and more particularly, to an artificial branched blood vessel and a preparation method thereof. Background Art

[0002] With the development of medical technology, replacement of diseased blood vessels has become the preferred method for treating vascular diseases.

[0003] Currently, the manufacture of branched blood vessels requires stitching the branches to the main blood vessel either by machine or manually. The medical suture at the stitching site is often exposed on the inner side of the blood vessel wall. When blood passes through the inner side of the blood vessel wall, thrombin and platelets in the blood are likely to accumulate at the suture. Long-term accumulation is likely to form thrombus at the suture on the inner wall of the blood vessel. And the stitching strength usually cannot meet the usage requirements. Summary of the Invention

[0004] The purpose of the present invention is to provide a stitching method that reduces thrombus formation and leakage at the stitching site of a branched blood vessel.

[0005] Specifically, the present invention provides an artificial branched blood vessel, including a main blood vessel and a branched blood vessel. A window is opened on the wall of the main blood vessel. The branched blood vessel is located at the window and connected to the main blood vessel. The branched blood vessel includes a branched main body and a connecting portion at one end of the branched main body. At the window, the inner wall of the connecting portion fits with the inner wall of the main blood vessel to form a joint portion, and a first loop of stitching is formed on the joint portion by a first suture.

[0006] Optionally, the axial length of the joint portion is 1.8 mm to 2.2 mm.

[0007] Optionally, the first loop of stitching is a purse-string suture method.

[0008] Optionally, the first suture passes through a plurality of first stitching holes, and at least part of the first stitching holes penetrate through the joint portion.

[0009] Optionally, the artificial branched blood vessel further includes a second loop of stitching formed on the joint portion by a second suture, and the second loop of stitching is located on the side of the first loop of stitching away from the branched main body.

[0010] Optionally, the first suture passes through a plurality of first stitching holes, the density of the first stitching holes is 1 to 20 per mm, the second suture passes through a plurality of second stitching holes, and the density of the second stitching holes is 1 to 20 per mm.

[0011] Optionally, more than half of the second suture holes are located on the same side of the first suture line; or, more than half of the second suture holes are separately disposed on both sides of the first suture line; and the shortest distance from more than half of the second suture holes to the first suture hole is greater than 0 mm and less than or equal to 10 mm.

[0012] Optionally, at least a portion of the second suture holes are located on the suture trace of the first suture line.

[0013] Optionally, the second suture line passes through a plurality of second suture holes, and the second suture line axially passes through every two oppositely disposed second suture holes along the branch blood vessel.

[0014] Optionally, the joint further includes a reinforcing layer, and the reinforcing layer is located between the inner wall of the connecting portion and the inner wall of the main blood vessel.

[0015] The present invention also provides a method for manufacturing an artificial branched blood vessel, comprising the following steps:

[0016] Providing a main blood vessel and a branch blood vessel, wherein a window is formed on the tube wall of the main blood vessel, and the branch blood vessel includes a branch main body and a connecting portion located at one end of the branch main body;

[0017] At the window, the inner wall of the connecting portion is attached to the inner wall of the main blood vessel to form a joint, and the joint is sutured in a first circle by a first suture line using a purse-string suture method;

[0018] The joint is sutured in a second circle by a second suture line, and the second suture line axially passes through every two oppositely disposed second suture holes along the branch blood vessel.

[0019] The beneficial effects of the present invention are as follows:

[0020] The present invention provides an artificial branched blood vessel and a manufacturing method thereof, which provides technical guarantee for the clinical application of the branched blood vessel. The artificial branched blood vessel has a firm connection, is not easy to cause blood leakage, and has good mechanical properties; and the number of suture lines inside the blood vessel is not large, and it is not easy to cause thrombus formation. Description of the Drawings

[0021] In order to more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for use in the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0022] Figures 1 to 5Schematic diagram of suture for an embodiment of the present invention;

[0023] Figure 6 Schematic diagram of the reinforcement layer adopted in an embodiment of the present invention. Detailed implementation manners

[0024] Reference to the embodiments of the present invention will now be provided in detail, one or more examples of which are described below. Each example is provided by way of explanation and not limitation of the present invention. In fact, it will be apparent to those skilled in the art that various modifications and variations can be made to the present invention without departing from the scope or spirit of the present invention. For example, features illustrated or described as part of one embodiment can be used in another embodiment to yield a further embodiment.

[0025] Accordingly, it is intended that the present invention cover such modifications and variations that fall within the scope of the appended claims and their equivalents. Other objects, features, and aspects of the present invention are disclosed in or are apparent from the following detailed description. Those of ordinary skill in the art should understand that this discussion is only a description of exemplary embodiments and is not intended to limit the broader aspects of the present invention.

[0026] The present invention relates to an artificial branched blood vessel, comprising a main blood vessel and a branched blood vessel. A window is formed in the wall of the main blood vessel, and the branched blood vessel is located at the window and connected to the main blood vessel. The branched blood vessel includes a branched main body and a connecting portion located at one end of the branched main body. At the window, the inner wall of the connecting portion fits with the inner wall of the main blood vessel to form a joint portion, and a first loop of sutures is formed on the joint portion by a first suture.

[0027] The artificial branched blood vessel provided by the present invention provides technical support for the clinical application of branched blood vessels. The artificial branched blood vessel is firmly connected, not easily causing blood leakage, and has good mechanical properties; and the number of sutures inside the blood vessel is not large, not easily causing thrombus formation.

[0028] Optionally, the number of branched blood vessels can be one or more, such as 2, 3, 4, 5, 6, 7, 8, 9, 10 or more, and different branched blood vessels are connected to the main blood vessel through different windows.

[0029] In some embodiments, the axial length of the joint portion is 1.8 mm to 2.2 mm, and can also be 1.9 mm, 2.0 mm or 2.1 mm.

[0030] In a preferred solution, the outer diameter dimension of the connecting portion is the same as the width of the window.

[0031] If the outer diameter dimension of the connecting part and the width of the window are too small, it may not be possible to effectively achieve the purpose of strengthening the joint; if too wide, it may lead to a decrease in the dynamic compliance of the blood vessels at the artificial branched blood vessel joint, and the decrease in compliance can easily lead to thrombosis or bleeding around the joint and its vicinity. The width of the connecting part and the window is an optimized range obtained by the applicant through a large number of clinical experiments.

[0032] In some embodiments, the connecting part is an extension of the branch main body, and the material and structure of the connecting part are the same as those of the branch main body.

[0033] In some embodiments, the first suture passes through a plurality of first suture holes, and at least part of the first suture holes penetrate through the joint.

[0034] It is easy to understand that the first suture holes can also penetrate only one of the connecting part or the main blood vessel, and it can also form a joint in cooperation with other first suture holes. Preferably, among the other first suture holes adjacent to the first suture holes that only penetrate the connecting part, at least the main blood vessel (or penetrate the joint) should be penetrated; among the other first suture holes adjacent to the first suture holes that only penetrate the main blood vessel, at least the connecting part (or penetrate the joint) should be penetrated.

[0035] In some embodiments, all of the first suture holes penetrate through the joint.

[0036] In some embodiments, the first suture passes through a plurality of first suture holes, and the density of the first suture holes is 1 to 20 per mm, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 or 19 per mm.

[0037] In some embodiments, the second suture passes through a plurality of second suture holes, and the density of the second suture holes is 1 to 20 per mm, such as 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18 or 19 per mm.

[0038] In some embodiments, more than half of the second suture holes are located on the same side of the first suture.

[0039] In some embodiments, more than half of the second suture holes are distributed on both sides of the first suture.

[0040] In some embodiments, the shortest distance from more than half of the second suture holes to the first suture is greater than 0 mm and less than or equal to 10 mm, such as 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 6 mm, 7 mm, 8 mm, 9 mm.

[0041] "More than half the number" means greater than 50%, for example, it can be 60%, 70%, 80%, 90% or all of the total amount.

[0042] In a preferred embodiment, nearly 100% of the second suture holes are located on both sides of the first suture line (that is, the number of second suture holes on both sides of the first suture line is basically equal), so as to ensure that the joint is sewn more firmly.

[0043] In some embodiments, at least a portion of the second suture holes are located on the suture trace of the first suture line.

[0044] Sharing the same holes can result in fewer holes being opened, so as not to damage the mechanical strength of the artificial branched blood vessel.

[0045] In some embodiments, the second suture line passes axially through every two relatively arranged second suture holes along the branch blood vessel.

[0046] The meaning of passing axially through every two relatively arranged second suture holes along the branch blood vessel is that the line connecting the corresponding needle entry point and needle exit point is basically parallel to the axis of the branch blood vessel each time. As used herein, the terms "substantially", "essentially" and their variants are intended to indicate that the described feature is equal to or approximately equal to the value or description. "Substantially parallel" is intended to mean that the angle between the line connecting the corresponding needle entry point and needle exit point and the axis can be within about 15°, such as about 10%, or within about 5%.

[0047] In some embodiments, the vast majority of the second suture holes are located on the same side of the first suture line and penetrate through the joint.

[0048] In some embodiments, the vast majority of the second suture holes are distributed on both sides of the first suture line, and the second suture holes on the side close to the main blood vessel penetrate through the joint, and the second suture holes on the side far from the main blood vessel penetrate through the joint or only penetrate through the connecting part.

[0049] In some embodiments, the first suture line and the second suture line are medical sutures.

[0050] In some embodiments, the artificial branched blood vessel is an aortic artificial branched blood vessel.

[0051] In some embodiments, the joint further includes a reinforcing layer, and the reinforcing layer is located between the inner wall of the connecting part and the inner wall of the main blood vessel. Preferably, the material and / or structure of the reinforcing layer is the same as that of the aforementioned connecting part.

[0052] In the present invention, the "artificial branched aortic blood vessel" is an artificial branched blood vessel used to replace the aorta, and the "aorta" belongs to the thoracic aorta (Aorta thoracalis) and the abdominal aorta (Aorta abdominalis).

[0053] The thoracic aorta is located in the thoracic cavity and its branches are divided into two types: visceral branches and parietal branches. Among them, the visceral branches supply the esophagus, pericardium, lungs, and the arteries of the trachea (not to be confused with the pulmonary artery used for gas exchange, which originates from the right ventricle). The thoracic aorta can be further divided into parts such as the ascending aorta, aortic arch, and descending aorta.

[0054] · The ascending aorta (Aorta ascendens) runs upward from the left ventricle and is separated from the left ventricle by the aortic valve. It is entirely located in the thoracic cavity and is several centimeters long. The coronary arteries originate from the bottom of the artery above the aortic valve and supply the myocardium.

[0055] · The aortic arch (Arcus aortae) is an extension of the ascending aorta. It is also located in the thoracic cavity and is connected to the descending aorta below. The aortic arch gives rise to the brachiocephalic trunk, left common carotid artery, and left subclavian artery from right to left, which are the three branches in the upper right of the right figure. These branches mainly supply the head and arms.

[0056] There are baroreceptors at the aortic arch, which can sense changes in blood pressure and achieve neural regulation by sending afferent impulses to the central nervous system.

[0057] · The aortic isthmus (Aortenisthmus), which is the end of the aortic arch and the beginning of the descending aorta.

[0058] · The descending aorta (Aorta descendens) descends from the aortic arch to the diaphragm and is located behind the heart. Its upper end is in front of the esophagus, and its lower end is behind it.

[0059] The abdominal aorta supplies all the organs in the abdominal cavity. It descends to the pelvic region and then divides into the left and right common iliac arteries (Arteriaeiliacae communes, also translated as common iliac arteries). It can be further divided into two parts:

[0060] · The suprarenal abdominal aorta (Aorta abdominalis suprarenalis), from the diaphragm to the branch points of the left and right renal arteries. Vessels that supply most of the intestines and the remaining digestive organs originate from this section.

[0061] · The infrarenal abdominal aorta, from the branching points of the left and right renal arteries to the point where the aorta finally divides into the left and right common iliac arteries, is also the last segment of the aorta. This part gives off some blood vessels that supply the intestines and pelvic organs, and finally reaches the pelvis, dividing into two large common iliac arteries.

[0062] In addition, the "aorta" is further preferably the aortic arch.

[0063] The present invention also relates to a method for manufacturing an artificial branched blood vessel, comprising the following steps:

[0064] Providing a main blood vessel and a branched blood vessel, wherein a window is formed on the wall of the main blood vessel, and the branched blood vessel includes a branched body and a connecting portion located at one end of the branched body;

[0065] At the window, fitting the inner wall of the connecting portion with the inner wall of the main blood vessel to form a joint portion, and performing a first circle of suturing on the joint portion by using a purse-string suture method with a first suture;

[0066] Performing a second circle of suturing on the joint portion by a second suture, and the second suture axially passes through every two oppositely arranged second suture holes along the branched blood vessel.

[0067] In some embodiments, the connecting portion is sutured to the main blood vessel by using a purse-string suture method.

[0068] In some embodiments, one continuous suture around for one week is one circle in the purse-string suture method.

[0069] In some embodiments, the first suture has 1, 2, 3, 4, 5 or more circles.

[0070] In some embodiments, the first suture is preferably 1 or 2 circles, and the suture position is close to the end and / or base of the joint portion.

[0071] In some embodiments, the total number of stitches in the purse-string suture method is calculated by the following formula:

[0072] F = (3.14 × D) / average number of stitches per millimeter (stitches / mm);

[0073] Where: D is the diameter of the branched blood vessel (mm); F is the total number of stitches for one branched blood vessel.

[0074] Hereinafter, the embodiments of the present invention will be described in detail in conjunction with the examples.

[0075] Example 1

[0076] A suture method for reducing thrombosis and leakage at the suture site. Taking a single-branched blood vessel as an example, the suture method is specifically realized through the following steps:

[0077] The first step is the flanging before suture; the second step is the first-round suture, and the third step is the second-round suture;

[0078] First step: Before the first-round suture, a flanging with a certain width is made at one end of the branched blood vessel. The width of the flanging is 2 mm, and this flanging serves as the connecting part of the branched blood vessel. At the same time, a flanging is also set at the window opening on the wall of the main blood vessel. The functions of the flanging are: (1) facilitating the fitting of the inner wall of the connecting part with the inner wall of the main blood vessel; (2) facilitating the tightening of the suture during the first-round suture, so that the suture is not easily exposed inside the blood vessel wall, thereby reducing the probability of thrombosis formation on the inner side of the blood vessel wall at the blood vessel suture site.

[0079] Second step: At the window of the main blood vessel, the inner wall of the connecting part is fitted with the inner wall of the main blood vessel to form a joint part, and the joint part is subjected to the first-round suture through the first suture line. The first-round suture refers to using a purse-string suture method (see Figure 1 ) to suture the connecting part of the branched blood vessel and the main blood vessel together through a certain number of stitches. The stitch pattern of the first-round suture is as Figure 2 shown; the purse-string suture refers to the suture walking to form a circular ring (see Figure 1 ); the certain number of stitches for the suture is 1 to 20 stitches / mm; the number of stitches refers to one stitch when the suture with a needle passes through both the main blood vessel and the branched blood vessel; the conversion formula for the total number of stitches and the number of stitches per millimeter is:

[0080] F = (3.14 × D) / number of stitches per millimeter (stitches / mm); Formula 1

[0081] In the formula: D is the diameter of the branched blood vessel (mm); F is the total number of stitches for one side branch.

[0082] Third step: The joint part is subjected to the second-round suture through the second suture line. The second suture line passes through every two relatively arranged second suture holes along the axial direction of the branched blood vessel. The stitch pattern of the second-round suture is as Figure 4As shown, the second circle of suturing is to insert the needle and exit the needle on the same side, and the needle insertion and exit are at a certain distance from the first circle of suturing. The so-called "certain distance" means that the distances from the needle insertion and exit of the second circle of suturing to the first circle of suturing are both 0-10 mm; the number of stitches sutured in the second circle of suturing is 0-20 stitches / mm. The purpose of the second circle of suturing is: (1) Tighten the main blood vessel and the branch blood vessel to make them fit more closely. The close fit of the main blood vessel and the branch blood vessel is beneficial to reducing the loosening of the suture at the suture site under the action of diastolic and systolic blood pressures. If the suture at the suture site is loose, it is easy for the first circle of suture to be exposed to the inner side of the blood vessel wall, thereby forming a thrombus; (2) After the second circle of suturing, the suture is exposed on the outer side of the blood vessel wall, and the exposed suture is beneficial to cell crawling and granulation tissue growth.

[0083] Example 2

[0084] A suture method for reducing thrombus formation and leakage at the suture site, taking a single-branch blood vessel as an example, the suture method is specifically realized through the following steps:

[0085] 1. Flange the head end of the suture of the branch blood vessel, and the width of the flange is 2 mm (see Figure 5 ).

[0086] 2. After the flanging is completed, perform the first circle of purse-string suture on the joint, and use a suture with a needle to suture the connecting part of the branch blood vessel and the main blood vessel together in a circular shape (see Figure 3 ); The number of stitches sutured in the first circle of purse-string suture is 136 stitches (that is, 0.2 stitches / mm, which can be obtained by calculation using formula 1).

[0087] 3. After the first circle of suturing, perform the second circle of suturing on the joint. The number of stitches sutured in the second circle of suturing is 190 stitches (that is, 0.1 stitches / mm, which can be obtained by calculation using formula 1). The position of the needle insertion or exit for the flanging suture is 0.5 mm away from the first circle of suturing. After each needle insertion or exit is completed, tighten the suture to make the main blood vessel and the branch blood vessel fit closely.

[0088] Example 3

[0089] Example 3 is the same as Example 2, the only difference is that in step 2, before performing the first circle of purse-string suture on the joint:

[0090] Cut a 2-mm-long sample from the branch blood vessel or other blood vessels of the same specification as it, and use it as the reinforcement layer for the suture of the branch blood vessel. Put the prepared reinforcement layer (see Figure 6 ) on the head end of the branch blood vessel to be sutured, and this reinforcement layer is located between the inner walls of the connecting part and the main blood vessel. Suture the joint.

[0091] The technical features of the above-described embodiments can be combined arbitrarily. For the sake of brevity of description, not all possible combinations of the technical features in the above-described embodiments are described. However, as long as there is no contradiction in the combination of these technical features, it should be considered to be within the scope described in this specification.

[0092] The above-described embodiments merely represent several implementation manners of the present invention. The description is relatively specific and detailed, but it should not be construed as a limitation on the scope of the invention patent. It should be noted that for those of ordinary skill in the art, without departing from the concept of the present invention, several modifications and improvements can still be made, and these all belong to the protection scope of the present invention. Therefore, the protection scope of the present invention patent shall be subject to the appended claims.

Claims

1. An artificial branched blood vessel, comprising a main blood vessel and a branched blood vessel, characterized in that, A window is formed on the wall of the main blood vessel, and the branch blood vessel is located at the window and connected to the main blood vessel; the branch blood vessel includes a branch main body and a connecting portion located at one end of the branch main body. At the window, the inner wall of the connecting portion is attached to the inner wall of the main blood vessel to form a joint portion, and a first circle of suturing is performed on the joint portion by a first suture thread, and the first circle of suturing is a purse-string suture method; a second circle of suturing is performed on the joint portion by a second suture thread; the second suture thread passes through a plurality of second suture holes, and the second suture thread axially passes through every two relatively arranged second suture holes along the branch blood vessel. During the preparation process of the artificial branched blood vessel, a flange is provided at one end of the branch blood vessel as the connecting portion of the branch blood vessel, and at the same time, a flange is also provided at the window of the main blood vessel; the artificial branched blood vessel is an aortic artificial branched blood vessel.

2. The artificial branched blood vessel according to claim 1, wherein The axial length of the joint portion is 1.8 mm to 2.2 mm.

3. The artificial branched blood vessel according to claim 1, wherein The first suture thread passes through a plurality of first suture holes, and at least part of the first suture holes penetrate through the joint portion.

4. The artificial branched blood vessel according to claim 1, wherein The first suture thread passes through a plurality of first suture holes, and the density of the first suture holes is 1 to 20 per mm. The second suture thread passes through a plurality of second suture holes, and the density of the second suture holes is 1 to 20 per mm.

5. The artificial branched blood vessel according to claim 4, characterized in that, More than half of the second suture holes are located on the same side of the first suture thread; or, more than half of the second suture holes are separately arranged on both sides of the first suture thread; And the shortest distance from more than half of the second suture holes to the first suture hole is greater than 0 mm and less than or equal to 10 mm.

6. The artificial branched blood vessel according to claim 1 or 4, characterized in that, At least part of the second suture holes are located on the suture trace of the first suture thread.

7. The artificial branched blood vessel according to claim 1, characterized in that The joint portion further includes a reinforcing layer, and the reinforcing layer is located between the inner wall of the connecting portion and the inner wall of the main blood vessel.

8. A preparation method of an artificial branched blood vessel, characterized in that, The artificial branched blood vessel is an aortic artificial branched blood vessel, and the preparation method comprises the following steps: Providing a main blood vessel and a branch blood vessel, a window is formed on the wall of the main blood vessel, and a flange is provided at one end of the branch blood vessel as a connecting portion, so that the branch blood vessel forms a structure including a branch main body and a connecting portion located at one end of the branch main body; Providing a flange at the window, attaching the flange of the branch blood vessel to the flange of the window, so that at the window, the inner wall of the connecting portion is attached to the inner wall of the main blood vessel to form a joint portion, and a first circle of suturing is performed on the joint portion by a first suture thread using the purse-string suture method; Performing a second circle of suturing on the joint portion by a second suture thread, the second suture thread passes through a plurality of second suture holes, and the second suture thread axially passes through every two relatively arranged second suture holes along the branch blood vessel.

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