Catheter sheath with postoperative hemostasis function

Abstract

The invention provides a catheter sheath with a postoperative hemostasis function. The catheter sheath comprises an outer sleeve, a plugging structure arranged on the outer side of the far end of the outer sleeve, and a water dissolving structure arranged on the outer side of the far end of the outer sleeve and connected with the plugging structure. The water dissolving structure is configured between the outer sleeve and the plugging structure along the radial direction, or the water dissolving structure is configured on one side of the plugging structure along the direction in which the outer sleeve is withdrawn from the blood vessel; when the water dissolving structure is dissolved in the blood, a height difference in the radial direction is formed between the plugging structure and the outer sleeve, so that the plugging structure is separated from the outer sleeve when the outer sleeve is withdrawn from the blood vessel. By means of the hemostasis device, automatic hemostasis is achieved in the process that the catheter sheath is withdrawn out of the blood vessel.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to a catheter sheath with a postoperative hemostasis function. Background Art

[0002] At the end of the interventional procedure, the catheter sheath needs to be withdrawn from the blood vessel, leaving a wound on the blood vessel wall. Currently, in the process of withdrawing the catheter sheath from the blood vessel in the prior art, complex operations or additional manual intervention are usually required to achieve hemostasis, thereby increasing the difficulty and time of the operation. Summary of the invention

[0003] The purpose of the present invention is to provide a catheter sheath with a postoperative hemostasis function, in particular to achieve automatic hemostasis when the catheter sheath is withdrawn from a blood vessel.

[0004] The present invention provides a catheter sheath with a postoperative hemostasis function, comprising: an outer sleeve, a blocking structure arranged outside the distal end of the outer sleeve, and a water-soluble structure arranged outside the distal end of the outer sleeve and connected to the blocking structure;

[0005] The water-soluble structure is arranged between the outer sleeve and the blocking structure in the radial direction, or the water-soluble structure is arranged on one side of the blocking structure in the direction in which the outer sleeve is withdrawn from the blood vessel;

[0006] When the water-soluble structure dissolves in the blood, a height difference in the radial direction is formed between the blocking structure and the outer sleeve, so that the blocking structure is separated from the outer sleeve when the outer sleeve is withdrawn from the blood vessel.

[0007] According to the present invention, in some solutions, the water-soluble structure is partially covered by the blocking structure and forms a portion exposed outside the blocking structure.

[0008] According to the present invention, in some solutions, the portion of the water-soluble structure exposed outside the blocking structure extends along the direction in which the outer sheath is withdrawn from the blood vessel to form an exposed section.

[0009] According to the present invention, in some solutions, the rear end of the blocking structure in the direction in which the outer sleeve is withdrawn from the blood vessel is connected to the front end of the water-soluble structure in the direction in which the outer sleeve is withdrawn from the blood vessel.

[0010] According to the present invention, in some solutions, the length of the water-soluble structure along the axial direction of the outer sleeve is 0.1 to 0.2 mm.

[0011] According to the present invention, in some solutions, the thickness of the water-soluble structure and the blocking structure along the radial direction J is 300 to 600 μm.

[0012] According to the present invention, in some solutions, the length of the blocking structure along the axial direction of the outer sleeve satisfies the following formula (1):

[0013]

[0014] The parameter l is the length of the blocking structure along the axial direction of the outer sleeve, and the parameter x is the outer circumference of the outer sleeve.

[0015] According to the present invention, in some solutions, the area of ​​the blocking structure is larger than the area of ​​the distal tube opening of the outer sleeve;

[0016] The area of ​​the blocking structure and the area of ​​the distal end of the outer sleeve satisfy the following formula (2):

[0017] A1≥A2 (2)

[0018] Wherein, parameter A1 is the area of ​​the blocking structure, and parameter A2 is the area of ​​the distal end of the outer sleeve;

[0019] The area of ​​the blocking structure is calculated as follows:

[0020] A1=x*l (3)

[0021] Wherein, parameter A1 is the area of ​​the blocking structure, parameter x is the outer circumference of the outer sleeve, and parameter l is the length of the blocking structure along the axial direction of the outer sleeve;

[0022] The area of ​​the distal end of the outer sleeve is calculated as follows:

[0023]

[0024] Among them, parameter A2 is the area of ​​the distal end of the outer sleeve, and parameter x is the outer circumference of the outer sleeve.

[0025] According to the present invention, in some embodiments, the material of the water-soluble structure is a water-soluble polymer material.

[0026] According to the present invention, in some embodiments, the water-soluble polymer material includes at least one of polyacrylamide, polyacrylic acid, polyvinyl pyrrolidone, polyvinyl alcohol, polymaleic anhydride, polyquaternary ammonium salt, and polyethylene glycol.

[0027] According to the present invention, in some solutions, the material of the blocking structure is a degradable polymer material.

[0028] According to the present invention, in some embodiments, the degradable polymer material includes at least one of a natural polymer material and a synthetic polymer material.

[0029] According to the present invention, in some embodiments, the natural polymer material includes at least one of gelatin, collagen, cellulose, starch, and chitin;

[0030] The synthetic polymer material includes at least one of polylactic acid, polyurethane, polycaprolactone, and polylactic acid-glycolic acid copolymer.

[0031] The catheter sheath with postoperative hemostasis function according to the present invention has the following beneficial technical effects: the water-soluble structure is dissolved by contacting the blood, so that a radial height difference is formed between the sealing structure and the outer sleeve, so that when the catheter sheath is withdrawn from the blood vessel, the sealing structure is intercepted by the hole wall of the puncture hole, so that the sealing structure can be smoothly separated from the outer sleeve and accumulated at the puncture hole of the blood vessel, thereby sealing the puncture hole after the catheter sheath is completely withdrawn from the blood vessel, so as to achieve automated hemostasis, reduce the complexity of the surgical operation, and reduce the difficulty and time of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] Figure 1 The schematic diagram of the structure of the catheter sheath with postoperative hemostasis function of the present invention is shown, wherein the water-soluble structure is arranged between the outer sleeve and the blocking structure along the radial direction;

[0033] Figure 2 A schematic structural diagram of a catheter sheath with a postoperative hemostasis function according to the present invention is shown, wherein the water-soluble structure is arranged on one side of the blocking structure along the direction in which the outer sheath is withdrawn from the blood vessel;

[0034] Figure 3 A cross-sectional view showing a water-soluble structure disposed between the outer sleeve and the plugging structure in a radial direction;

[0035] Figure 4 A cross-sectional view showing a water-soluble structure disposed on one side of the blocking structure in the direction in which the outer sleeve is withdrawn from the blood vessel;

[0036] Figure 5 A cross-sectional view showing a water-soluble structure disposed between an outer sleeve and a plugging structure in a radial direction, wherein the water-soluble structure extends to form an exposed section;

[0037] Figure 6 A cross-sectional view showing a water-soluble structure disposed between the outer sleeve and the blocking structure along the radial direction from another viewing angle, wherein the water-soluble structure has been dissolved in the blood;

[0038] Figure 7 A cross-sectional view showing a water-soluble structure disposed on one side of the blocking structure in the direction in which the outer sleeve is withdrawn from the blood vessel from another viewing angle, wherein the water-soluble structure has been dissolved in the blood;

[0039] Figure 8A schematic diagram of the catheter sheath with postoperative hemostasis function of the present invention is shown, wherein the water-soluble structure is arranged between the outer sleeve and the blocking structure along the radial direction, and the water-soluble structure has been dissolved in the blood;

[0040] Fig. 9 The schematic diagram of the catheter sheath with postoperative hemostasis function of the present invention being inserted into a blood vessel is shown, wherein the water-soluble structure is arranged on one side of the blocking structure along the direction of the outer sleeve being withdrawn from the blood vessel, and the water-soluble structure has been dissolved in the blood. DETAILED DESCRIPTION

[0041] In order to make the purpose, technical solution and advantages of the technical solution of the present disclosure clearer, the technical solution of the embodiment of the present disclosure will be clearly and completely described in combination with the drawings of the specific embodiments of the present disclosure. The same figure marks in the drawings represent the same parts. It should be noted that the described embodiments are part of the embodiments of the present disclosure, not all of the embodiments. Based on the described embodiments of the present disclosure, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present disclosure.

[0042] Unless otherwise defined, the technical terms or scientific terms used herein shall have the usual meanings understood by persons of ordinary skill in the field to which the present invention belongs. The words "first", "second" and similar words used in the patent application specification and claims of the present invention do not indicate any order, quantity or importance, but are only used to distinguish different components. Words such as "include" or "comprise" mean that the elements or objects appearing before the word include the elements or objects listed after the word and their equivalents, without excluding other elements or objects. "Inside", "outside", "upper", "lower", "far", "near", "front", "back" and the like are only used to indicate relative positional relationships. When the absolute position of the described object changes, the relative positional relationship may also change accordingly. The drawings in this disclosure are not strictly drawn according to the actual scale, and the specific size and quantity of each structure can be determined according to actual needs. The drawings described in this disclosure are only schematic diagrams of the structure.

[0043] The drawings in the present invention are not drawn strictly according to the actual scale, and the specific size of each structure can be determined according to actual needs. The drawings described in the present invention are only schematic diagrams of the structures.

[0044] It should be noted that "axial" refers to Figure 1 or Figure 2 The direction indicated by the axis Q of the middle outer sleeve 10. "Radial" refers to the direction J through the axis Q.

[0045] The main function of the catheter sheath is to provide protection for access maintenance, angiography and device delivery during interventional surgery. Therefore, most cardiovascular, peripheral and intracranial treatment procedures use catheter sheaths. At the end of the interventional surgery, the catheter sheath needs to be withdrawn from the blood vessel, leaving a wound on the blood vessel wall. Compression hemostasis is often used clinically to stop bleeding from vascular wounds. However, compression hemostasis takes a long time and requires the presence of medical staff during the operation; and the wounds that are compressed and hemostatic are prone to secondary bleeding, causing additional burden on patients.

[0046] Some catheter sheaths in the prior art, for example, can change from a folded state to an open state by pushing a stretcher into a blood vessel, thereby blocking the puncture on the blood vessel and achieving a hemostatic effect. For another example, a pushing device uses an outer sleeve and a dial mechanism to accurately push the hemostatic material to the puncture point, covering the outer wall of the blood vessel to achieve a hemostatic effect. However, the catheter sheaths in the prior art require complex operations to solve the problem of postoperative hemostasis, which increases the difficulty and time of the operation.

[0047] Since the human blood vessel 200 has significant elasticity and contraction ability, when the catheter sheath 100 is inserted into the blood vessel 200, the puncture hole 201 will temporarily become larger due to mechanical expansion. However, due to the elasticity of the blood vessel 200 and the contraction ability of the smooth muscle, the vascular tissue around the puncture hole 201 will quickly adjust and try to restore to the original diameter, so that the hole wall 202 of the puncture hole 201 can fit the outer peripheral wall 12 of the outer sleeve 10 as much as possible to reduce blood leakage to the outside.

[0048] The present application discloses a catheter sheath 100 with a postoperative hemostasis function (hereinafter referred to as "catheter sheath 100" for short). Compared with the catheter sheath in the prior art, the catheter sheath 100 is dissolved by contacting the blood through the water-soluble structure 30, so that a radial height difference is formed between the blocking structure 20 and the outer sleeve 10, so that when the catheter sheath 100 is withdrawn from the blood vessel 200, the blocking structure 20 is intercepted by the hole wall 202 of the puncture hole 201, so that the blocking structure 20 can be smoothly separated from the outer sleeve 10 and accumulated at the puncture hole 201 of the blood vessel 200, so that the puncture hole 201 is blocked after the catheter sheath 100 is completely withdrawn from the blood vessel 200, so as to achieve automatic hemostasis, reduce the complexity of the surgical operation, and reduce the difficulty and time of the operation.

[0049] Please refer to Figures 1 to 9 A specific embodiment of a catheter sheath 100 with postoperative hemostasis function is disclosed.

[0050] The catheter sheath 100 comprises: an outer sleeve 10, a blocking structure 20 disposed outside the distal end 11 of the outer sleeve 10, and a water-soluble structure 30 disposed outside the distal end 11 of the outer sleeve 10 (i.e., the end entering the human blood vessel) and connected to the blocking structure 20; the water-soluble structure 30a is disposed between the outer sleeve 10 and the blocking structure 20 along the radial direction J, or the water-soluble structure 30b is disposed in the direction in which the blocking structure 20 is withdrawn from the blood vessel along the outer sleeve 10 (e.g., the direction in which the outer sleeve 10 is withdrawn from the blood vessel). Figure 2 when the water-soluble structure 30 dissolves in the blood, a height difference in the radial direction is formed between the blocking structure 20 and the outer sleeve 10, so that the blocking structure 20 is detached from the outer sleeve 10 when the outer sleeve 10 is withdrawn from the blood vessel.

[0051] In the catheter sheath 100 provided in the above embodiment of the present application, during the operation, the distal end 11 of the outer sleeve 10 is inserted into the blood vessel 200, and the hole wall 202 of the puncture hole 201 is attached to the outer peripheral wall 12 of the outer sleeve 10. Figure 1 and Figure 3 and Figure 6 and Figure 8 As shown, the blocking structure 20 and the water-soluble structure 30a are immersed in the blood. As the water-soluble structure 30a dissolves, the connection between the blocking structure 20 and the outer sleeve 10 gradually weakens. When the operation is completed and the catheter sheath 100 needs to be withdrawn, the water-soluble structure 30a is completely dissolved, so that a height difference H1 along the radial direction J is formed between the blocking structure 20 and the outer sleeve 10. In other words, after the water-soluble structure 30a is completely dissolved, an annular gap M is finally formed between the blocking structure 20 and the outer sleeve 10. Since the hole wall 202 of the puncture hole 201 fits the outer peripheral wall 12 of the outer sleeve 10, the catheter sheath 100 can be moved along the radial direction J. Figure 8 During the process of withdrawing the blood vessel 200 in the direction indicated by the middle arrow X, the puncture hole 201 can intercept the blocking structure 20, so that the blocking structure 20 gradually detaches from the outer sleeve 10 as the catheter sheath 100 is withdrawn. Since a height difference H1 is formed between the blocking structure 20 and the outer sleeve 10 along the radial direction J, the blocking structure 20 can smoothly detach from the outer sleeve 10 and accumulate at the puncture hole 201, so as to block the puncture hole 201 after the catheter sheath 100 is completely withdrawn from the blood vessel 200, thereby forming a physical barrier at the puncture hole 201 to prevent blood from flowing out, thereby realizing automatic hemostasis.

[0052] In some examples, reference Figure 2 and Figure 4 and Figure 7 and Fig. 9As shown, the blocking structure 20 and the water-soluble structure 30b are immersed in the blood, and the water-soluble structure 30b begins to dissolve. When the operation is completed and the catheter sheath 100 needs to be withdrawn, the water-soluble structure 30b is completely dissolved, so that a height difference H2 is formed between the blocking structure 20 and the outer sleeve 10 along the radial direction J. Since the hole wall 202 of the puncture hole 201 fits the outer peripheral wall 12 of the outer sleeve 10, the height difference H2 is formed along the radial direction J between the blocking structure 20 and the outer sleeve 10. Fig. 9 During the process of withdrawing the blood vessel 200 in the direction indicated by the middle arrow X, the puncture hole 201 can intercept the blocking structure 20, so that the blocking structure 20 gradually detaches from the outer sleeve 10 as the catheter sheath 100 is withdrawn. Due to the height difference H2 formed between the blocking structure 20 and the outer sleeve 10 along the radial direction J, the blocking structure 20 can smoothly detach from the outer sleeve 10 and accumulate at the puncture hole 201, and block the puncture hole 201 after the catheter sheath 100 is completely withdrawn from the blood vessel 200, thereby forming a physical barrier at the puncture hole 201 to prevent blood from flowing out, thereby realizing automatic hemostasis.

[0053] In some examples, reference Figure 3 As shown, the water-soluble structure 30a is partially covered by the blocking structure 20, and forms a portion 31 exposed outside the blocking structure 20. After the catheter sheath 100 is inserted into the blood vessel 200, the water-soluble structure 30a contacts the blood through the exposed portion 31, so that the water-soluble structure 30a gradually dissolves in the blood, slowing down the dissolution rate of the water-soluble structure 30a, ensuring that the water-soluble structure 30a can be completely dissolved in the blood at the right time, so that a height difference H1 in the radial direction is formed between the blocking structure 20 and the outer sleeve 10, so as to prevent the water-soluble structure 30a from being completely dissolved in the blood at the right time. Fig. 9 During the process of withdrawing the blood vessel 200 in the direction indicated by the middle arrow X, the blocking structure 20 can be smoothly detached from the outer sleeve 10 and block the puncture hole 201 to achieve automatic hemostasis.

[0054] In some examples, reference Figure 5 As shown, the portion 31 of the water-soluble structure 30a exposed outside the blocking structure 20 extends in the direction of the outer sleeve 10 being withdrawn from the blood vessel to form an exposed section 32. After the catheter sheath 100 is inserted into the blood vessel 200, the exposed section 32 contacts the blood in the blood vessel 200. Since the exposed section 32 is located outside the blocking structure 20 and extends in the withdrawal direction, the exposed section 32 of the water-soluble structure 30a can dissolve faster, and the dissolution of the exposed section 32 triggers the dissolution of the entire water-soluble structure 30a, so that the water-soluble structure 30a can gradually dissolve in the blood, ensuring that the blocking structure 20 can form a height difference H1 in the radial direction with the outer sleeve 10 at the right time, so as to prevent the blocking structure 20 from being blocked by the outer sleeve 10 when the catheter sheath 100 is inserted into the blood vessel 200. Fig. 9 During the process of withdrawing the blood vessel 200 in the direction indicated by the middle arrow X, the blocking structure 20 can be smoothly detached from the outer sleeve 10 and block the puncture hole 201 to achieve automatic hemostasis.

[0055] In some examples, reference Figure 4 As shown, the rear end 21 of the blocking structure 20 in the direction in which the outer sleeve 10 is withdrawn from the blood vessel is connected to the front end 33 of the water-soluble structure 30b in the direction in which the outer sleeve 10 is withdrawn from the blood vessel.

[0056] After the catheter sheath 100 is inserted into the blood vessel 200, the water-soluble structure 30b can play a supporting role. The water-soluble structure 30b forms a temporary buffer behind the blocking structure 20, which can offset part of the interference force, maintain the stability of the blocking structure 20, and prevent the blocking structure 20 from being disturbed by factors such as blood flow and intravascular pressure during positioning, so as to stabilize the blocking structure 20 and keep the blocking structure 20 in the correct blocking position, thereby improving the accuracy and success rate of the operation. After the water-soluble structure 30b dissolves in the blood, the rear end 21 of the blocking structure 20 is no longer supported by the water-soluble structure 30b, and a height difference H2 is formed between the blocking structure 20 and the outer sleeve 10 along the radial direction J, so that when the catheter sheath 100 is moved along the Fig. 9 During the process of withdrawing the blood vessel 200 in the direction indicated by the middle arrow X, the puncture hole 201 intercepts the rear end 21 of the blocking structure 20 so that the blocking structure 20 can be smoothly detached from the outer sleeve 10 and accumulated in the puncture hole 201, and the puncture hole 201 is blocked after the catheter sheath 100 is completely withdrawn from the blood vessel 200 to achieve automatic hemostasis.

[0057] In some examples, the material of the water-soluble structure 30 is a water-soluble polymer material. The water-soluble polymer material can dissolve rapidly or gradually in a body fluid environment such as blood, and can dissolve itself after the water-soluble structure 30 completes its supporting function, thereby avoiding affecting the closure structure 20 from being separated from the outer sleeve 10 and avoiding long-term interference with the blood vessel. Since the water-soluble polymer material has good biocompatibility, it can avoid inducing immune response, inflammation or other adverse reactions during the dissolution process, thereby ensuring the safety of the patient. After the water-soluble structure 30 dissolves, its products can be cleared through normal metabolic pathways, further reducing the potential impact on the vascular environment. In addition, the water-soluble polymer material has good processability, which facilitates the preparation of the water-soluble structure 30 into a structural form suitable for specific application requirements. For example, the water-soluble structure 30 can be accurately coated on the distal end 11 of the outer sleeve 10 by a process of dipping, spraying or brushing, so that it can form an effective temporary support structure during deployment. The processability of the water-soluble polymer material provides support for the above-mentioned coating process, so that the water-soluble structure 30 can be uniformly attached to the distal end 11 of the outer sleeve 10 in the form of a film or a coating.

[0058] Specifically, the water-soluble polymer material includes at least one of polyacrylamide (PAM), polyacrylic acid (PAA), polyvinylpyrrolidone (PVP), polyvinyl alcohol (PVA), polymaleic anhydride (Polymaleic Anhydride), polyquaternium, and polyethylene glycol (PEG).

[0059] In some examples, the material of the blocking structure 20 is a degradable polymer material. The biodegradable properties of the degradable polymer material enable the blocking structure 20 to fit tightly to the puncture hole 201 after being detached from the outer sleeve 10, thereby preventing blood leakage and achieving reliable postoperative hemostasis. In addition, the blocking structure 20 can be gradually absorbed by the body, without the need for secondary surgery to remove it, reducing the patient's pain and risk. After completing the blood vessel occlusion, the blocking structure 20 can gradually degrade in the human body and be cleared through normal metabolic pathways, avoiding the potential impact of long-term retention on blood vessels or surrounding tissues, and has good biocompatibility and mechanical properties.

[0060] Specifically, the degradable polymer material includes at least one of a natural polymer material and a synthetic polymer material. Natural polymer materials are derived from natural resources, have excellent biocompatibility and degradability, and their degradation products are usually non-toxic substances that can be normally metabolized by the human body. Synthetic polymer materials can flexibly regulate the degradation rate, mechanical strength and other functional properties of the material through the design of the molecular structure. The two can be used alone or in combination to meet the performance requirements of the blocking structure 20 in different scenarios, ensuring that sufficient blocking support can be provided, and that long-term residual effects on blood vessels can be avoided through degradation after the blocking task is completed.

[0061] In some examples, natural polymer materials and synthetic polymer materials also have good processability, which facilitates the preparation of the plugging structure 20 into a structural form suitable for specific application requirements. For example, the plugging structure 20 can be accurately coated on the distal end 11 of the outer sleeve 10 or the outside of the water-soluble structure 30 by a process of dipping, spraying or brushing. Relying on the processability of natural polymer materials and synthetic polymer materials, support is provided for the above-mentioned coating process, so that the plugging structure 20 can be uniformly attached to the distal end 11 of the outer sleeve 10 or the outside of the water-soluble structure 30 in the form of a film or coating, thereby meeting specific plugging function requirements.

[0062] The natural polymer material includes at least one of gelatin, collagen, cellulose, starch, and chitosan; the synthetic polymer material includes at least one of polylactic acid (PLA), polyurethane (PU), polycaprolactone (PCL), and poly(lactic-co-glycolic acid) (PLGA).

[0063] In some examples, the thickness of the water-soluble structure 30 and the blocking structure 20 along the radial direction J is 300 to 600 μm.

[0064] Ginseng Figure 1 , Figure 3 , Figure 5 , Figure 6 and Figure 8 As shown, when the water-soluble structure 30a is completely dissolved, a height difference H1 is formed between the blocking structure 20 and the outer sleeve 10 along the radial direction J, and the height difference H1 corresponds to the thickness of the water-soluble structure 30a. The height difference H1 enables the blocking structure 20 to be smoothly separated from the outer sleeve 10 during the process of the catheter sheath 100 being withdrawn from the blood vessel 200, thereby preventing the blocking structure 20 from being taken out of the body with the outer sleeve 10. Through the height difference H1, it is ensured that the blocking structure 20 is accumulated at the puncture hole 201 after the water-soluble structure 30a is dissolved, thereby achieving reliable postoperative hemostasis.

[0065] Ginseng Figure 2 , Figure 4 , Figure 7 and Fig. 9 As shown, when the water-soluble structure 30b is completely dissolved, a height difference H2 is formed between the blocking structure 20 and the outer sleeve 10 along the radial direction J, and the height difference H2 corresponds to the thickness of the blocking structure 20 itself. The height difference H2 also ensures that the blocking structure 20 can naturally detach from the outer sleeve 10 during the withdrawal process and smoothly accumulate at the puncture hole 201 to achieve postoperative hemostasis. In addition, the height difference H2 also provides the blocking structure 20 with sufficient thickness to effectively seal the puncture hole 201, prevent blood leakage, and further improve the reliability of hemostasis.

[0066] In some examples, the length of the water-soluble structure 30 along the axial direction of the outer sleeve 10 is 0.1 to 0.2 mm.

[0067] In some examples, the length of the occluding structure 20 in the axial direction of the outer sleeve 10 is related to the outer circumference of the outer sleeve 10. The size of the catheter sheath 100 is usually measured in F (Fr, French), where 1F equals 1 mm of circumference.

[0068] The length of the blocking structure 20 along the axial direction of the outer sleeve 10 satisfies the following formula (1):

[0069]

[0070] The parameter l is the length of the blocking structure 20 along the axial direction of the outer sleeve 10 (unit: mm), and the parameter x is the outer circumference of the outer sleeve 10 (unit: mm).

[0071] For example, when the size of the outer sleeve 10 is 10F, its outer circumference x = 10 mm, and substituting it into formula (1) yields:

[0072]

[0073] Similarly, when the size of the outer sleeve 10 is 15F, its outer circumference x = 15 mm, and substituting it into formula (1) yields:

[0074]

[0075] From the above calculation, it can be known that the length of the blocking structure 20 increases linearly with the increase of the size of the outer sleeve 10, but the ratio to the area of ​​the tube opening of the outer sleeve 10 always remains consistent, ensuring that the blocking structure 20 can reliably close the puncture hole 201.

[0076] For example, in some examples, a section of the blocking structure 20 is first coated by dip coating at the distal end 11 of the outer sleeve 10, and the material of the blocking structure 20 is gelatin, and then a layer of the water-soluble structure 30 is coated by dip coating, and the material of the water-soluble structure 30 is polyvinyl alcohol. When the size of the outer sleeve 10 is 10F, the length of the blocking structure 20 along the axial direction of the outer sleeve 10 is 0.8 mm, and the length of the water-soluble structure 30 along the axial direction of the outer sleeve 10 is 0.1 mm.

[0077] For example, in some examples, a section of the blocking structure 20 is first coated by spraying at the distal end 11 of the outer sleeve 10, and the material of the blocking structure 20 is polylactic acid, and then a layer of the water-soluble structure 30 is coated by spraying, and the material of the water-soluble structure 30 is polyvinyl alcohol. When the size of the outer sleeve 15 is 10F, the length of the blocking structure 20 along the axial direction of the outer sleeve 10 is 1.2 mm, and the length of the water-soluble structure 30 along the axial direction of the outer sleeve 10 is 0.2 mm.

[0078] In some examples, the area of ​​the blocking structure 20 is larger than the area of ​​the distal tube opening of the outer tube 10; the area of ​​the blocking structure 20 is larger than the area of ​​the distal tube opening of the outer tube 10 to ensure that the blocking structure 20 completely covers the puncture hole 201, and the larger area of ​​the blocking structure 20 can provide additional safety margin. Even if there is a small gap between the blocking structure 20 and the puncture hole 201, the larger coverage area of ​​the blocking structure 20 can still effectively seal the puncture hole 201, thereby effectively preventing blood leakage and ensuring the reliability of postoperative hemostasis.

[0079] The area of ​​the blocking structure 20 and the area of ​​the distal end of the outer sleeve 10 satisfy the following formula (2):

[0080] A1>A2 (2)

[0081] Wherein, parameter A1 is the area of ​​the blocking structure 20, and parameter A2 is the area of ​​the distal end of the outer sleeve 10;

[0082] The area of ​​the blocking structure 20 is calculated as follows:

[0083] A1=x*l (3)

[0084] Wherein, parameter A1 is the area of ​​the blocking structure 20, parameter x is the outer perimeter of the outer sleeve 10, and parameter l is the length of the blocking structure 20 along the axial direction of the outer sleeve 10;

[0085] The area of ​​the distal end of the outer sleeve 10 is calculated as follows:

[0086]

[0087] The parameter A2 is the area of ​​the distal end of the outer sleeve 10 , and the parameter x is the outer circumference of the outer sleeve 10 .

[0088] For example, when the size of the outer sleeve 10 is 10F, the coating length l of the blocking structure 20 is 0.8 mm. According to formula (3):

[0089] A1=x*l=10×0.8=8.00m2

[0090] According to formula (4):

[0091]

[0092] Therefore, A1>A2, satisfying the requirement of formula (2).

[0093] The above are only specific embodiments of the present disclosure, but the protection scope of the present disclosure is not limited thereto. Any technician familiar with the technical field can easily think of changes or substitutions within the technical scope disclosed in the present disclosure, which should be included in the protection scope of the present disclosure. Therefore, the protection scope of the present disclosure should be based on the protection scope of the claims.

Claims

1. A catheter sheath with postoperative hemostasis function, characterized in that: include: An outer sleeve, a blocking structure disposed on the outer side of the distal end of the outer sleeve, and a water-soluble structure disposed on the outer side of the distal end of the outer sleeve and connected to the blocking structure; The water-soluble structure is arranged between the outer sleeve and the blocking structure in the radial direction, or the water-soluble structure is arranged on one side of the blocking structure in the direction in which the outer sleeve is withdrawn from the blood vessel; When the water-soluble structure dissolves in the blood, a height difference in the radial direction is formed between the blocking structure and the outer sleeve, so that the blocking structure is separated from the outer sleeve when the outer sleeve is withdrawn from the blood vessel.

2. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that: The water-soluble structure is partially covered by the blocking structure and forms a portion exposed outside the blocking structure.

3. The catheter sheath with postoperative hemostasis function according to claim 2, characterized in that: The portion of the water-soluble structure exposed outside the blocking structure extends in a direction in which the outer sleeve is withdrawn from the blood vessel to form an exposed section.

4. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that: The rear end of the blocking structure in the direction in which the outer sleeve is withdrawn from the blood vessel is connected to the front end of the water-soluble structure in the direction in which the outer sleeve is withdrawn from the blood vessel.

5. The catheter sheath with postoperative hemostasis function according to any one of claims 1 to 4, characterized in that: The length of the water-soluble structure along the axial direction of the outer sleeve is 0.1 to 0.2 mm.

6. The catheter sheath with postoperative hemostasis function according to any one of claims 1 to 4, characterized in that: The thickness of the water-dissolving structure and the blocking structure along the radial direction is 300 to 600 μm.

7. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that: The length of the blocking structure along the axial direction of the outer sleeve satisfies the following formula (1): The parameter l is the length of the blocking structure along the axial direction of the outer sleeve, and the parameter x is the outer circumference of the outer sleeve.

8. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that: The area of ​​the blocking structure is larger than the area of ​​the distal end of the outer sleeve; The area of ​​the blocking structure and the area of ​​the distal end of the outer sleeve satisfy the following formula (2): A1>A2 (2) Wherein, parameter A1 is the area of ​​the blocking structure, and parameter A2 is the area of ​​the distal end of the outer sleeve; The area of ​​the blocking structure is calculated as follows: A1=x*l (3) Wherein, parameter A1 is the area of ​​the blocking structure, parameter x is the outer circumference of the outer sleeve, and parameter l is the length of the blocking structure along the axial direction of the outer sleeve; The area of ​​the distal end of the outer sleeve is calculated as follows: Among them, parameter A2 is the area of ​​the distal end of the outer sleeve, and parameter x is the outer circumference of the outer sleeve.

9. The catheter sheath with postoperative hemostasis function according to any one of claims 7 or 8, characterized in that: The material of the water-soluble structure is a water-soluble polymer material.

10. The catheter sheath with postoperative hemostasis function according to claim 9, characterized in that: The water-soluble polymer material includes at least one of polyacrylamide, polyacrylic acid, polyvinyl pyrrolidone, polyvinyl alcohol, polymaleic anhydride, polyquaternary ammonium salt and polyethylene glycol.

11. The catheter sheath with postoperative hemostasis function according to any one of claims 7 or 8, characterized in that: The material of the blocking structure is a degradable polymer material.

12. The catheter sheath with postoperative hemostasis function according to claim 11, characterized in that: The degradable polymer material includes at least one of a natural polymer material and a synthetic polymer material.

13. The catheter sheath with postoperative hemostasis function according to claim 12, characterized in that: The natural polymer material includes at least one of gelatin, collagen, cellulose, starch and chitin; The synthetic polymer material includes at least one of polylactic acid, polyurethane, polycaprolactone, and polylactic acid-glycolic acid copolymer.

Images