Artificial blood vessel

Abstract

The invention relates to an artificial blood vessel. The artificial blood vessel comprises a tubular structure and at least one protective plate sleeve, the protective plate sleeve is arranged outside the tubular structure in a sleeving manner and at least covers a part of the tubular structure; the protection plate sleeve comprises a front wall and a rear wall, the front wall and the rear wall are connected to form a continuous pipe body, the front wall is provided with a puncture window, and the puncture window penetrates from the outer surface of the front wall to the inner surface of the front wall; the puncture window comprises a curve structure, and the curve structure comprises at least one wave crest and at least one wave trough. The artificial blood vessel not only can protect and avoid complete penetration of a puncture needle, but also has a long puncture path and is long in service life.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more particularly to an artificial blood vessel. Background Technology

[0002] Dialysis treatment for individuals with kidney failure requires drawing blood and circulating it through a dialysis machine that functions the failing kidneys. This process, known as hemodialysis, must be repeated at regular intervals (e.g., three times a week), necessitating repeated punctures using a dialysis needle. A relatively large needle is required to facilitate the high flow rates needed during dialysis. Large-diameter needles used for autogenous arteriovenous access can cause trauma, catheter degeneration, hematoma formation, pseudoaneurysm formation, loss of patency, and even bleeding or phlebotomy. Currently, autogenous arteriovenous fistulas (AVFs) and artificial arteriovenous grafts (AVGs) are the primary methods for constructing upper limb hemodialysis access.

[0003] Arteriovenous fistulas (AVGs) are surgically created by artificially establishing a bypass between an artery and a vein, providing a long-term and effective vascular access for extracorporeal circulation during hemodialysis. Planned, regular, and standardized AVG puncture procedures and maintenance are crucial for maintaining long-term vascular access function. For long-term dialysis patients, typically undergoing dialysis three times a week, the puncture point should be at least 3cm from the anastomosis, with puncture point intervals of 0.5-1.0cm and arteriovenous puncture point intervals of at least 5cm. A step-by-step puncture technique is usually employed, alternating puncture sites. Buttonhole punctures and repeated punctures at the same site are strictly prohibited to avoid excessive damage to the artificial blood vessel, leakage, pseudoaneurysms, and other complications, thus reducing the lifespan of the artificial blood vessel. Furthermore, AVG dialysis requires highly skilled nursing staff for puncture procedures. Incorrect puncture site selection may lead to complications at the puncture site and patient discomfort. Frequent failures may cause patients to lose confidence in hemodialysis, resulting in anxiety. Excessive needle punctures can cause painful posterior wall punctures and damage, leading to unnecessary bleeding, treatment delays or cessation, and reduced durability of the artificial blood vessel. Summary of the Invention

[0004] Therefore, it is necessary to provide a dialysis vessel that can reduce dialysis complications and has a longer service life.

[0005] This invention provides an artificial blood vessel, comprising: a tubular structure and at least one protective sleeve;

[0006] The protective sleeve is fitted over the tubular structure and covers at least a portion of the tubular structure; the protective sleeve includes a front wall and a rear wall, which are connected to form a continuous tube; the front wall has a puncture window that extends from the outer surface of the front wall to the inner surface of the front wall; the puncture window includes a curved structure, which includes at least one peak and at least one trough.

[0007] In some embodiments, on any cross-section of the protective sleeve, the puncture window and the inner surface of the protective sleeve have a first intersection point and a second intersection point, the distance between the first intersection point and the second intersection point is d, and the distance d satisfies: 2.5mm≤d≤3.5mm.

[0008] In some embodiments, the tubular structure is provided with a radiopaque line that coincides with the edge of the puncture window.

[0009] In some embodiments, the tubular structure is provided with a plurality of imaging points, which are distributed at intervals along the extension direction of the puncture window within the area defined by the puncture window; the distance between each imaging point and any other imaging point is greater than or equal to 7 mm.

[0010] In some embodiments, the tubular structure includes an inner layer, an outer layer, and an intermediate layer located between the inner and outer layers; the intermediate layer includes elastic segments and covered segments, the number of elastic segments being the same as the number of protective sleeves, with each protective sleeve covering one elastic segment; in the length direction of the artificial blood vessel, the length of the elastic segment is greater than the length of the puncture window.

[0011] In some embodiments, the elastic segment includes a first body layer and a first transition layer disposed inside the first body layer and a second transition layer disposed outside the first body layer; the inner layer includes a second body layer and a third transition layer disposed outside the second body layer; the outer layer includes a third body layer and a fourth transition layer disposed inside the third body layer; the first transition layer and the third transition layer are interlocked, and the second transition layer and the fourth transition layer are interlocked.

[0012] In some embodiments, the coated section is made of the same material as the inner and outer layers; the porosity of the inner and outer layers is 80% to 90%, and the porosity of the coated section is 30% to 40%.

[0013] In some embodiments, the protective plate sleeve is provided with a plurality of strip-shaped cutouts extending circumferentially along the protective plate sleeve, the width of the strip-shaped cutouts being less than 1 mm.

[0014] In some embodiments, the tubular structure includes a curved section and two puncture sections respectively connected to both ends of the curved section, each puncture section being provided with at least one of the protective sleeves.

[0015] In some embodiments, the artificial blood vessel further includes a helix disposed on the curved section and spirally wrapped around the outside of the tubular structure.

[0016] The artificial blood vessel of the present invention prevents leakage caused by complete penetration of the puncture needle by setting a protective sleeve on the outermost layer. A puncture window with a curved structure is provided on the protective sleeve, extending the puncture path on the artificial blood vessel. That is, along the length of the artificial blood vessel, the puncture window of the artificial blood vessel of the present invention can accommodate more puncture points, and the distance between any two puncture points can meet the requirements. Therefore, the artificial blood vessel of the present invention not only protects against complete penetration of the puncture needle, but also has a longer puncture path and a longer service life. Attached Figure Description

[0017] Figure 1 This is a three-dimensional view of the artificial blood vessel in Embodiment 1 of the present invention;

[0018] Figure 2 This is a perspective view of the protective sleeve in Embodiment 1 of the present invention;

[0019] Figure 3 This is a front view of the puncture window in Embodiment 1 of the present invention;

[0020] Figure 4 This is a front view of the protective sleeve in Embodiment 1 of the present invention;

[0021] Figure 5 for Figure 4 Cross-sectional view at point AA;

[0022] Figure 6 This is a perspective view of the tubular structure in Embodiment 1 of the present invention;

[0023] Figure 7 This is a perspective view of an artificial blood vessel in another embodiment of the present invention;

[0024] Figure 8 This is a partial longitudinal cross-sectional schematic diagram of the artificial blood vessel in Embodiment 1 of the present invention;

[0025] Figure 9 This is a flowchart illustrating the preparation process of the tubular structure in Embodiment 1 of the present invention;

[0026] Figure 10 This is a three-dimensional view of the artificial blood vessel in Embodiment 2 of the present invention;

[0027] Figure 11 This is a three-dimensional view of the artificial blood vessel in Embodiment 3 of the present invention;

[0028] Figure 12 This is a perspective view of the protective sleeve in Embodiment 3 of the present invention. Detailed Implementation

[0029] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0030] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the specification of this invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0031] To more clearly describe the structure of this application, the terms "proximal" and "distal" are used herein as conventional terms in the field of interventional medicine. Specifically, "distal" refers to the end furthest from the operator during the surgical procedure, "proximal" refers to the end closest to the operator during the surgical procedure, "axial" refers to its length direction, and "radial" refers to the direction perpendicular to the "axial".

[0032] Example 1

[0033] like Figure 1 As shown, this embodiment provides an artificial blood vessel 100, which includes: a tubular structure 110 and at least one protective sleeve 120;

[0034] The protective sleeve 120 is fitted over the tubular structure 110 and at least covers a portion of the tubular structure 110; such as Figure 2 As shown, the protective sleeve 120 includes a front wall 121 and a rear wall 122, which are connected to form a continuous tube. The front wall 121 has a puncture window 1211, which extends from the outer surface of the front wall 121 to the inner surface of the front wall 121. Figure 3 As shown, the puncture window 1211 includes a curved structure 12111, which includes at least one peak 12111a and at least one trough 12111b.

[0035] After the artificial blood vessel 100 is implanted into the human body, the front wall 121 of the protective sleeve 120 faces the skin surface, while the rear wall 122 of the protective sleeve 120 is farther from the skin surface than the front wall 121. The puncture needle can penetrate the skin surface and pass through the puncture window 1211 but cannot pass through the rear wall 122, thus preventing the puncture needle from completely penetrating the artificial blood vessel 100 and causing bleeding. The protective sleeve 120 is provided with a puncture window 1211 with a curved structure 12111, extending the puncture path on the artificial blood vessel 100. That is, in the length direction of the artificial blood vessel, the puncture window 1211 of the artificial blood vessel 100 of the present invention can accommodate more puncture points, and the distance between any two puncture points can meet the requirements. Therefore, the artificial blood vessel 100 of the present invention not only protects against complete penetration by the puncture needle but also has a longer puncture path and a longer service life.

[0036] The protective sleeve 120 is made of polyetheretherketone (PEEK) material with a thickness of 0.2 to 0.3 mm and is fixed to the outer surface of the tubular structure 110 by an adhesive. During puncture, the puncture needle cannot penetrate the protective sleeve 120, thereby preventing the puncture needle from exiting the artificial blood vessel 100 from the inside again, avoiding damage to the tissue surrounding the artificial blood vessel 100, and avoiding serious complications such as severe pain, bleeding, or hematoma.

[0037] At any cross-section of the protective sleeve 120, the puncture window 1211 and the inner surface of the protective sleeve 120 have a first intersection point and a second intersection point, and the distance between the first intersection point and the second intersection point is d, which satisfies: 2.5mm ≤ d ≤ 3.5mm. For ease of understanding, this embodiment uses the cross-section AA of the protective sleeve 120 as an example, such as... Figure 5 As shown, on the cross-section AA, the puncture window 1211 and the inner surface 123 of the protective sleeve 120 have a first intersection point M and a second intersection point N. The distance between the first intersection point M and the second intersection point N is d. The size of d determines the outer diameter of the puncture needle that the puncture window 1211 can accommodate. When using a puncture needle with an outer diameter of 2 mm for puncture, the distance d should be greater than 2 mm, so that the puncture window 1211 has a certain width of needle insertion area in the circumferential direction of the artificial blood vessel 100, which facilitates the nurse's puncture operation.

[0038] As shown in the figure Figure 1 and Figure 6 As shown, the tubular structure 110 includes a curved section 111 and two puncture sections 112 respectively connected to both ends of the curved section 111. Each puncture section 112 is provided with at least one of the aforementioned protective sleeves 120. In this embodiment, each puncture section 112 is provided with one protective sleeve 120. In other embodiments, more than one protective sleeve may be provided on the puncture section, such as... Figure 7As shown, in one of the other embodiments, each puncture segment 112a is provided with two protective sleeves 120a.

[0039] When the artificial blood vessel 100 is implanted into the patient's body, it needs to be folded in half to adapt to the shape of the patient's arm. The curved section 111 is bent, and the two puncture sections 112 are distributed on both sides of the curved section 111. In this embodiment, the artificial blood vessel 100 also includes a spiral 130, which is disposed on the curved section and spirally wrapped around the tubular structure 110. The spiral 130 improves the flexibility of the artificial blood vessel 100 and prevents wrinkles from forming when the artificial blood vessel 100 is bent, thus reducing the flow area. In this embodiment, the spiral 130 is a polytetrafluoroethylene (PTFE) wire or a perfluoroethylene propylene (PFEP) wire with a diameter of 0.5-1 mm. It is fixed to the outer layer 115 of the blood vessel with an adhesive, and the wire spacing is 0.5-1.5 mm.

[0040] Looking back Figure 6 The tubular structure 110 is provided with a radiopaque line 113, which coincides with the edge of the puncture window 1211. In this embodiment, the radiopaque line 113 is drawn on the outer surface of the inner layer 114 or the outer layer 115 using barium sulfate paint. Under X-ray, the radiopaque line 113 reveals the shape of the puncture window 1211, and the nurse performs the puncture according to the shape of the puncture window 1211; or, using a skin marker pen that can maintain its ink quality for a long time, the edge of the puncture window 1211 is drawn onto the patient's skin surface under X-ray, and the nurse performs the puncture according to the ink quality. In other embodiments, the radiopaque line is drawn on the outer surface of the inner layer or the outer layer using microbubble polyurethane paint, and the radiopaque line can be visualized under ultrasound.

[0041] like Figure 8 As shown, the tubular structure 110 includes an inner layer 114, an outer layer 115, and an intermediate layer 116 located between the inner layer 114 and the outer layer 115. The intermediate layer 116 includes an elastic segment 1161 and a covering segment 1162. The number of elastic segments 1161 is the same as the number of protective sleeves 120, and each protective sleeve 120 is fitted over one elastic segment 1161. In the length direction of the artificial blood vessel 100, the length of the elastic segment 1161 is greater than the length of the puncture window 1211. The elastic segment 1161 is made of a self-sealing elastic material such as silicone. The elastic segment 1161 can automatically close after puncture by the puncture needle, so that the artificial blood vessel 100 of the present invention can be punctured on the same day or the next day after implantation, without having to spend several weeks waiting for the artificial blood vessel 100 to complete endothelialization.

[0042] The covered segment 1162 is made of the same material as the inner layer 114 and the outer layer 115, all of which are made of polytetrafluoroethylene (PTFE) film. Therefore, the covered segment 1162 has a high degree of adhesion to the inner layer 114 and the outer layer 115. The elastic segment 1161 is tightly wrapped within the space formed by the covered segment 1162, the inner layer 114, and the outer layer 115, preventing the elastic segment 1161 from being exposed at the end of the artificial blood vessel 100 and effectively preventing the artificial blood vessel 100 from delaminating. At the same time, compared with the elastic segment 1161, the artificial blood vessel 100 formed by the three layers of PTFE film—the inner layer 114, the covered segment 1162, and the outer layer 115—has better flexibility at both ends, making it easier for doctors to suture. The inner layer 114, the membrane section 1162, and the outer layer 115 are made of polytetrafluoroethylene (PTFE) emulsion through electrospinning technology. By adjusting the electrospinning parameters, PTFE membranes of different densities and porosities are obtained. The porosity of the inner layer 114 and the outer layer 115 is 80%–90%, and the porosity of the membrane section 1162 is 30%–40%. The use of a low-porosity PTFE membrane in the membrane section 1162 ensures the impermeability of the artificial blood vessel 100, while the use of a high-porosity PTFE membrane in the inner layer 114 and the outer layer 115 further reduces the rigidity of the artificial blood vessel 100, thereby obtaining a highly flexible artificial blood vessel 100.

[0043] The elastic segment 1161 includes a first body layer 11611 and a first transition layer 11612 and a second transition layer 11613 respectively disposed inside and outside the first body layer 11611; the inner layer 114 includes a second body layer 1141 and a third transition layer 1142 disposed outside the second body layer 1141; the outer layer 115 includes a third body layer 1151 and a fourth transition layer 1152 disposed inside the third body layer 1151; the first transition layer 11612 and the third transition layer 1142 are interlocked with each other, and the second transition layer 11613 and the fourth transition layer 1152 are interlocked with each other.

[0044] Specifically, such as Figure 9 As shown, the manufacturing steps are as follows: (1) Electrospinning is performed on the mandrel device 01 using polytetrafluoroethylene to obtain the second body layer 1141 (e.g. Figure 9 (a) as shown in the figure); (2) Silicone wires are wound around the outer surface of the second body layer 1141 to obtain the first transition layer 11612 (as shown in the figure); (3) Silicone wires are wound around the outer surface of the second body layer 1141 to obtain the first transition layer 11612 (as shown in the figure). Figure 9 (b) ); (3) Continue electrospinning with polytetrafluoroethylene to obtain a third transition layer 1142, wherein the silicone wire portion is exposed in the third transition layer 1142 (as shown in b ... Figure 9 (c) (4) The first body layer 11611 is formed by casting on the outside of the third transition layer 1142, and the coated section 1162 is obtained by electrospinning polytetrafluoroethylene at a position outside the first body layer 11611 (as shown in c); Figure 9 (d) ; (5) The fourth transition layer 1152 is formed by electrospinning polytetrafluoroethylene on the first body layer 11611, and the first body layer 11611 is partially exposed to the fourth transition layer 1152 (e.g., as shown in d); Figure 9 (e)); (6) Wrap silicone wire around the fourth transition layer 1152 to form the second transition layer 11613 (as shown in e); (7) Wrap silicone wire around the fourth transition layer 1152 to form the second transition layer 11613 (as shown in e). Figure 9 (as shown in f); (7) Finally, electrospinning is continued outside the second transition layer 11613 and the coating section 1162 to obtain the third body layer 1151 (as shown in f); (8) Finally, electrospinning is continued outside the second transition layer 11613 and the coating section 1162 to obtain the third body layer 1151 (as shown in f); Figure 9 (As shown in g). After hot pressing, the second body layer 1141 and the third transition layer 1142 are tightly bonded together, the first body layer 11611, the first transition layer 11612, and the second transition layer 11613 are tightly bonded together, and the third body layer 1151 and the fourth transition layer 1152 are tightly bonded together. Therefore, the first transition layer 11612 and the third transition layer 1142 are interlocked with each other, and the second transition layer 11613 and the fourth transition layer 1152 are interlocked with each other, thereby making the inner layer 114, the elastic segment 1161, and the outer layer 115 tightly bonded together.

[0045] Therefore, the elastic segment 1161 retains its self-sealing function through the first body layer 11611, and is tightly bonded to the inner layer 114 and the outer layer 115 through the first transition layer 11612 and the second transition layer 11613, further avoiding delamination due to the different materials of the elastic segment 1161 and the inner layer 114 and the outer layer 115.

[0046] Example 2

[0047] The structure of the artificial blood vessel 200 in this embodiment is basically the same as that of the artificial blood vessel 100 in Embodiment 1, the main difference being that, Figure 10 As shown, in this embodiment, the tubular structure 210 of the artificial blood vessel 200 is provided with a plurality of imaging points 213. The plurality of imaging points 213 are distributed at intervals along the extension direction of the puncture window 2211 on the protective sleeve 220 within the area defined by the puncture window 2211. The distance between each imaging point 213 and any other imaging point 213 is greater than or equal to 7 mm. The appropriate distance between the imaging points 213 can prevent two adjacent puncture points from being too close together during the puncture process.

[0048] In this embodiment, the imaging point 213 is drawn by barium sulfate coating on the outer surface of the inner or outer layer of the tubular structure 210. The nurse performs puncture according to the location of the imaging point 213 under X-ray; or the imaging point 213 is drawn onto the patient's skin surface under X-ray using a skin marker pen that maintains its markings for a long time, and the nurse performs puncture according to the markings. In other embodiments, the imaging point is drawn by microbubble polyurethane coating on the outer surface of the inner or outer layer, and the imaging point can be visualized under ultrasound.

[0049] In this embodiment, the artificial blood vessel 200 further clarifies the puncture location by setting the imaging point 213, making the dialysis operation more standardized and regulated, effectively reducing the difficulty of dialysis for nursing staff, better maintaining and sustaining the function of the vascular access, and extending the service life of the dialysis blood vessel.

[0050] Example 3

[0051] The structure of the artificial blood vessel 300 in this embodiment is basically the same as that of the artificial blood vessel 100 in Embodiment 1, the main difference being that, Figure 11 As shown, in this embodiment, the artificial blood vessel 300 has multiple strip-shaped perforations 322 extending circumferentially along the artificial blood vessel on the protective sleeve 320, and the strip-shaped perforations 322 are distributed on both sides of the puncture window 321. The width of the strip-shaped perforations is less than 1 mm, that is, the width of the strip-shaped perforations 322 is much smaller than the width of the puncture needle, to prevent the puncture needle from penetrating the protective sleeve 320. By setting multiple strip-shaped perforations, the protective sleeve can be bent to a certain extent to adapt to the shape of the patient's arm.

[0052] Specifically, such as Figure 12 As shown, the plurality of strip-shaped perforations include a plurality of first perforations 3221 and a plurality of second perforations 3222. The plurality of first perforations 3221 and the plurality of second perforations 3222 are respectively arranged on both sides of the puncture window 321, and the width of the first perforation 3221 is greater than the width of the second perforation 3222, making it easier for the protective sleeve to bend toward the side of the second perforation 3222. When manufacturing the artificial blood vessel 300, by adjusting the relative position of the protective sleeve 320 and the tubular structure 310, the protective sleeves 320 respectively set at both ends of the curved section 311 of the tubular structure 310 are made easier to bend inward, thus obtaining the desired result. Figure 11 The artificial blood vessel structure shown is adapted to the physiological curvature of the patient's arm.

[0053] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0054] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An artificial blood vessel, characterized in that, include: Tubular structure and at least one protective sleeve; The protective sleeve is fitted over the tubular structure and covers at least a portion of the tubular structure; the protective sleeve includes a front wall and a rear wall, which are connected to form a continuous tube; the front wall has a puncture window that extends from the outer surface of the front wall to the inner surface of the front wall; the puncture window includes a curved structure, which includes at least one peak and at least one trough.

2. The artificial blood vessel according to claim 1, characterized in that: At any cross-section of the protective sleeve, the puncture window and the inner surface of the protective sleeve have a first intersection point and a second intersection point, and the distance between the first intersection point and the second intersection point is d, which satisfies: 2.5mm≤d≤3.5mm.

3. The artificial blood vessel according to claim 1, characterized in that: The tubular structure is provided with a radiopaque line, which coincides with the edge of the puncture window.

4. The artificial blood vessel according to claim 1, characterized in that: The tubular structure is provided with a plurality of imaging points, which are distributed at intervals along the extension direction of the puncture window within the area defined by the puncture window; the distance between each imaging point and any other imaging point is greater than or equal to 7 mm.

5. The artificial blood vessel according to claim 1, characterized in that: The tubular structure includes an inner layer, an outer layer, and an intermediate layer located between the inner and outer layers; the intermediate layer includes an elastic segment and a covered segment, the number of elastic segments being the same as the number of protective sleeves, and each protective sleeve being fitted over one elastic segment; in the length direction of the artificial blood vessel, the length of the elastic segment is greater than the length of the puncture window.

6. The artificial blood vessel according to claim 5, characterized in that: The elastic segment includes a first body layer, a first transition layer disposed inside the first body layer, and a second transition layer disposed outside the first body layer; the inner layer includes a second body layer and a third transition layer disposed outside the second body layer; the outer layer includes a third body layer and a fourth transition layer disposed inside the third body layer; the first transition layer and the third transition layer are interlocked, and the second transition layer and the fourth transition layer are interlocked.

7. The artificial blood vessel according to claim 5, characterized in that: The coated section is made of the same material as the inner and outer layers; the porosity of the inner and outer layers is 80% to 90%, and the porosity of the coated section is 30% to 40%.

8. The artificial blood vessel according to claim 1, characterized in that: The protective plate sleeve has multiple strip-shaped cutouts extending circumferentially along the protective plate sleeve, and the width of the strip-shaped cutouts is less than 1 mm.

9. The artificial blood vessel according to claim 1, characterized in that: The tubular structure includes a curved section and two puncture sections connected to both ends of the curved section, and each puncture section is provided with at least one of the protective sleeves.

10. The artificial blood vessel according to claim 9, characterized in that: The artificial blood vessel also includes a spiral line, which is disposed on the curved section and spirally wraps around the outside of the tubular structure.

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