A catheter sheath with post-operative hemostasis function

Abstract

The application provides a catheter sheath with postoperative hemostasis function, comprising: an outer sleeve, a blocking structure arranged outside a distal end of the outer sleeve, and a water dissolving structure arranged outside the distal end of the outer sleeve and connected with the blocking structure; the water dissolving structure is arranged between the outer sleeve and the blocking structure in a radial direction, or the water dissolving structure is arranged on one side of the blocking structure in a direction in which the blocking structure is withdrawn from the blood vessel along the outer sleeve; when the water dissolving structure is dissolved in blood, a height difference in the radial direction is formed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and the outer sleeve, so that the blocking structure is separated from the outer sleeve when the outer sleeve is withdrawn from the blood vessel. Through the application, automatic hemostasis of the catheter sheath during withdrawal from the blood vessel is realized.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a catheter sheath with postoperative hemostasis function. Background Technology

[0002] At the end of the interventional procedure, the catheter sheath needs to be withdrawn from the blood vessel, leaving a wound on the vessel wall. Currently, existing catheter sheaths typically require complex procedures or additional manual intervention to achieve hemostasis during withdrawal, thus increasing the difficulty and time of the procedure. Summary of the Invention

[0003] The purpose of this invention is to provide a catheter sheath with postoperative hemostasis function, especially to achieve automated hemostasis during the withdrawal of the catheter sheath from the blood vessel.

[0004] The present invention provides a catheter sheath with postoperative hemostasis function, comprising: an outer sheath, a sealing structure disposed on the distal outer side of the outer sheath, and a water-soluble structure disposed on the distal outer side of the outer sheath and connected to the sealing structure;

[0005] The water-soluble structure is disposed radially between the outer sheath and the sealing structure, or the water-soluble structure is disposed on one side of the sealing structure in the direction of withdrawal of the blood vessel from the outer sheath;

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

[0007] According to some embodiments of the present invention, the water-soluble structure is partially covered by the sealing structure, forming a portion exposed outside the sealing structure.

[0008] According to the invention, in some embodiments, the portion of the water-soluble structure exposed outside the occlusion structure extends along the direction in which the outer sheath withdraws from the blood vessel to form an exposed section.

[0009] According to the present invention, in some embodiments, the rear end of the blocking structure along the direction of withdrawal of the outer sheath from the blood vessel is connected to the front end of the water-dissolving structure along the direction of withdrawal of the outer sheath from the blood vessel.

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

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

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

[0013]

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

[0015] According to the present invention, in some embodiments, the area of ​​the sealing structure is larger than the area of ​​the distal end of the outer sleeve;

[0016] The area of ​​the sealing 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 sealing structure, and parameter A2 is the area of ​​the distal end of the outer sleeve.

[0019] The area of ​​the sealing structure is calculated using the following formula (3):

[0020] A1=x*l (3)

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

[0022] The area of ​​the distal end of the outer sleeve is calculated using the following formula (4):

[0023]

[0024] Wherein, parameter A2 is the area of ​​the distal end of the outer tube, and parameter x is the outer perimeter of the outer tube.

[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 polymeric material includes at least one selected from polyacrylamide, polyacrylic acid, polyvinylpyrrolidone, polyvinyl alcohol, polymaleic anhydride, polyquaternary ammonium salt, and polyethylene glycol.

[0027] According to the present invention, in some embodiments, the sealing structure is made of a biodegradable polymer material.

[0028] According to the present invention, in some embodiments, the biodegradable polymeric material includes at least one of natural polymeric materials and synthetic polymeric materials.

[0029] According to the present invention, in some embodiments, the natural polymeric 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-co-hydroxyacetic acid copolymer.

[0031] The catheter sheath with postoperative hemostasis function according to the present invention has the following beneficial technical effects: by dissolving the blood through the water-soluble structure, a radial height difference is formed between the occlusion structure and the outer sheath, so that during the process of the catheter sheath withdrawing from the blood vessel, the occlusion structure is intercepted by the hole wall of the puncture hole, so that the occlusion structure can smoothly detach from the outer sheath and accumulate 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. Attached Figure Description

[0032] Figure 1 A schematic diagram of the structure of the catheter sheath with postoperative hemostasis function of the present invention is shown, wherein the water-dissolving structure is arranged radially between the outer sheath and the sealing structure;

[0033] Figure 2 A 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 configured on one side of the sealing structure in the direction of withdrawal of the outer sheath from the blood vessel.

[0034] Figure 3 A cross-sectional view is shown showing the water-soluble structure arranged radially between the outer sleeve and the sealing structure;

[0035] Figure 4 A cross-sectional view is shown of a water-soluble structure configured on one side of the sealing structure along the direction in which the outer sheath withdraws from the blood vessel;

[0036] Figure 5 A cross-sectional view is shown of a water-soluble structure arranged radially between an outer casing and a sealing structure, wherein the water-soluble structure extends to form an exposed section;

[0037] Figure 6 A cross-sectional view is shown from another perspective, in which the water-soluble structure is arranged radially between the outer tube and the sealing structure, and the water-soluble structure has dissolved in the blood.

[0038] Figure 7 A cross-sectional view is shown from another perspective, in which the water-soluble structure is configured on one side of the occlusive structure along the direction in which the outer sheath withdraws from the blood vessel, wherein the water-soluble structure has 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 disposed radially between the outer sheath and the occlusion structure, and the water-soluble structure has dissolved in the blood.

[0040] Figure 9 A schematic diagram of the catheter sheath with postoperative hemostasis function of the present invention is shown, wherein the water-soluble structure is disposed on one side of the sealing structure along the direction of withdrawal of the outer sheath from the blood vessel, and the water-soluble structure has dissolved in the blood. Detailed Implementation

[0041] To make the objectives, technical solutions, and advantages of this disclosure clearer, the technical solutions of the embodiments of this disclosure will be clearly and completely described below with reference to the accompanying drawings. The same reference numerals in the drawings represent the same components. It should be noted that the described embodiments are only some, not all, of the embodiments of this disclosure. All other embodiments obtained by those skilled in the art based on the described embodiments of this disclosure without creative effort are within the scope of protection of this disclosure.

[0042] Unless otherwise defined, the technical or scientific terms used herein should have the ordinary meaning understood by one of ordinary skill in the art to which this invention pertains. The terms "first," "second," and similar words used in the specification and claims of this patent application do not indicate any order, quantity, or importance, but are merely used to distinguish different components. Terms such as "comprising" or "including" mean that the element or object preceding the word encompasses the elements or objects listed following the word and their equivalents, without excluding other elements or objects. Terms such as "inner," "outer," "upper," "lower," "far," "near," "front," and "rear" are used only to indicate relative positional relationships; these relative positional relationships may change accordingly when the absolute position of the described object changes. The drawings in this disclosure are not strictly drawn to scale; the specific dimensions and quantity of each structure can be determined according to actual needs. The drawings described in this disclosure are merely structural schematic diagrams.

[0043] The accompanying drawings in this invention are not strictly drawn to scale, and the specific dimensions of each structure can be determined according to actual needs. The drawings described in this invention are merely structural schematic diagrams.

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

[0045] The primary function of a catheter sheath is to provide access maintenance, angiography, and instrument delivery during interventional procedures. Therefore, most cardiovascular, peripheral, and intracranial treatments utilize catheter sheaths. At the end of the interventional procedure, the catheter sheath needs to be withdrawn from the blood vessel, leaving a wound in the vessel wall. Clinically, pressure hemostasis is commonly used to stop bleeding from this vascular wound. However, pressure hemostasis takes a long time, requires the presence of medical staff, and the wound is prone to secondary bleeding, causing additional burden on the patient.

[0046] Some existing catheter sheaths, for example, can change from a retracted to an open state after being pushed into the blood vessel, thereby blocking the puncture site and achieving hemostasis. Another example is the use of a pusher device with an outer sheath and a dial mechanism to accurately push hemostatic material to the puncture site, covering the outer wall of the blood vessel to achieve hemostasis. However, existing catheter sheaths require complex operations to solve postoperative hemostasis problems, increasing the difficulty and time of the procedure.

[0047] Because human blood vessels 200 have significant elasticity and contractile ability, when the catheter sheath 100 is inserted into the blood vessel 200, the puncture hole 201 will temporarily enlarge due to mechanical dilation. However, due to the elasticity of the blood vessel 200 and the contractile ability of smooth muscle, the vascular tissue around the puncture hole 201 will quickly adjust to restore its original diameter as much as possible, so that the hole wall 202 of the puncture hole 201 can fit as closely as possible to the outer peripheral wall 12 of the outer sheath 10 to reduce blood leakage to the outside.

[0048] The catheter sheath 100 (hereinafter referred to as "catheter sheath 100") disclosed in this application has a postoperative hemostasis function. Compared with the catheter sheaths in the prior art, the catheter sheath 100 dissolves in blood through the water-soluble structure 30, so that a radial height difference is formed between the sealing structure 20 and the outer sheath 10. During the withdrawal of the catheter sheath 100 from the blood vessel 200, the sealing structure 20 is intercepted by the hole wall 202 of the puncture hole 201, so that the sealing structure 20 can be smoothly detached from the outer sheath 10 and accumulate at the puncture hole 201 of the blood vessel 200. Thus, the puncture hole 201 is sealed after the catheter sheath 100 is completely withdrawn from the blood vessel 200, thereby achieving automated hemostasis, reducing the complexity of the surgical operation, and reducing 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 includes: an outer sheath 10, a occlusion structure 20 disposed outside the distal end 11 of the outer sheath 10, and a water-soluble structure 30 disposed outside the distal end 11 of the outer sheath 10 (i.e., the end that enters the blood vessel) and connected to the occlusion structure 20; the water-soluble structure 30a is disposed radially between the outer sheath 10 and the occlusion structure 20, or the water-soluble structure 30b is disposed in the direction in which the occlusion structure 20 exits the blood vessel along the outer sheath 10 (e.g., the direction in which it exits the blood vessel). Figure 2 On one side (in the direction indicated by the middle arrow X); when the water-soluble structure 30 dissolves in the blood, a radial height difference is formed between the sealing structure 20 and the outer sheath 10 so that the sealing structure 20 detaches from the outer sheath 10 when the outer sheath 10 is withdrawn from the blood vessel.

[0051] In the catheter sheath 100 provided in the above embodiments of this application, during surgery, the distal end 11 of the outer sheath 10 is inserted into the blood vessel 200, and the wall 202 of the puncture hole 201 is attached to the outer peripheral wall 12 of the outer sheath 10. In some examples, refer to Figure 1 and Figure 3 and Figure 6 and Figure 8 As shown, the sealing structure 20 and the water-dissolving structure 30a are immersed in blood. As the water-dissolving structure 30a dissolves, the connection between the sealing structure 20 and the outer sheath 10 gradually weakens. When the procedure is completed and the catheter sheath 100 needs to be withdrawn, the water-dissolving structure 30a completely dissolves, creating a height difference H1 in the radial direction J between the sealing structure 20 and the outer sheath 10. In other words, after the water-dissolving structure 30a completely dissolves, an annular gap M is finally formed between the sealing structure 20 and the outer sheath 10. Because the hole wall 202 of the puncture hole 201 adheres to the outer peripheral wall 12 of the outer sheath 10, the connection between the sealing structure 20 and the outer sheath 100 is maintained along the radial direction J. Figure 8 During the withdrawal of blood vessel 200 in the direction indicated by the middle arrow X, the puncture hole 201 can intercept the occlusion structure 20, so that the occlusion structure 20 gradually detaches from the outer cannula 10 as the catheter sheath 100 is withdrawn. Due to the height difference H1 formed between the occlusion structure 20 and the outer cannula 10 in the radial direction J, the occlusion structure 20 can smoothly detach from the outer cannula 10 and accumulate in the puncture hole 201, so as to seal the puncture hole 201 after the catheter sheath 100 is completely withdrawn from blood vessel 200, thereby forming a physical barrier in the puncture hole 201 to prevent blood from flowing out, so as to achieve automated hemostasis.

[0052] In some examples, the parameter Figure 2 and Figure 4 and Figure 7 and Figure 9As shown, the sealing structure 20 and the water-dissolving structure 30b are immersed in blood. At this time, the water-dissolving structure 30b begins to dissolve. When the procedure is completed and the catheter sheath 100 needs to be withdrawn, the water-dissolving structure 30b is completely dissolved, creating a height difference H2 in the radial direction J between the sealing structure 20 and the outer sheath 10. Because the hole wall 202 of the puncture hole 201 adheres to the outer peripheral wall 12 of the outer sheath 10, the catheter sheath 100 is positioned along... Figure 9 During the withdrawal of the blood vessel 200 in the direction indicated by the middle arrow X, the puncture hole 201 can intercept the sealing structure 20, so that the sealing structure 20 gradually detaches from the outer cannula 10 as the catheter sheath 100 is withdrawn. Due to the height difference H2 formed between the sealing structure 20 and the outer cannula 10 in the radial direction J, the sealing structure 20 can smoothly detach from the outer cannula 10 and accumulate in the puncture hole 201. After the catheter sheath 100 is completely withdrawn from the blood vessel 200, the puncture hole 201 is sealed, thereby forming a physical barrier in the puncture hole 201 to prevent blood from flowing out, so as to achieve automated hemostasis.

[0053] In some examples, the parameter Figure 3 As shown, the water-soluble structure 30a is partially covered by the sealing structure 20, forming a portion 31 exposed outside the sealing structure 20. After the catheter sheath 100 is inserted into the blood vessel 200, the water-soluble structure 30a comes into contact with the blood through the exposed portion 31, allowing the water-soluble structure 30a to gradually dissolve in the blood. This slows down the dissolution rate of the water-soluble structure 30a, ensuring that it completely dissolves in the blood at the appropriate time. This creates a radial height difference H1 between the sealing structure 20 and the outer sheath 10, allowing the catheter sheath 100 to... Figure 9 During the withdrawal of blood vessel 200 in the direction indicated by the middle arrow X, the sealing structure 20 can smoothly detach from the outer sheath 10 and seal the puncture hole 201 to achieve automated hemostasis.

[0054] In some examples, the parameter Figure 5 As shown, the portion 31 of the water-soluble structure 30a exposed outside the occlusion structure 20 extends along the direction of withdrawal of the outer cannula 10 from the blood vessel to form an exposed section 32. After the catheter sheath 100 is inserted into the blood vessel 200, it comes into contact with the blood in the blood vessel 200 through the exposed section 32. Because the exposed section 32 is located outside the occlusion structure 20 and extends along the withdrawal direction, the exposed section 32 of the water-soluble structure 30a can dissolve relatively quickly. The dissolution of the exposed section 32 triggers the dissolution of the entire water-soluble structure 30a, thereby allowing the water-soluble structure 30a to gradually dissolve in the blood. This ensures that the occlusion structure 20 can form a radial height difference H1 between itself and the outer cannula 10 at the appropriate time, so that the catheter sheath 100 can dissolve along the blood vessel 200. Figure 9 During the withdrawal of blood vessel 200 in the direction indicated by the middle arrow X, the sealing structure 20 can smoothly detach from the outer sheath 10 and seal the puncture hole 201 to achieve automated hemostasis.

[0055] In some examples, the parameter Figure 4 As shown, the rear end 21 of the sealing structure 20 along the direction of withdrawal from the blood vessel in the outer sleeve 10 is connected to the front end 33 of the water-dissolving structure 30b along the direction of withdrawal from the blood vessel in the outer sleeve 10.

[0056] After the catheter sheath 100 is inserted into the blood vessel 200, the water-soluble structure 30b provides support. The water-soluble structure 30b forms a temporary buffer zone behind the occlusion structure 20, which can offset some of the interference forces, maintain the stability of the occlusion structure 20, and prevent the occlusion structure 20 from being disturbed by factors such as blood flow and intravascular pressure during positioning. This stabilizes the occlusion structure 20, keeping it in the correct occlusion position, thereby improving the accuracy and success rate of the procedure. After the water-soluble structure 30b dissolves in the blood, the rear end 21 of the occlusion structure 20 is no longer supported by the water-soluble structure 30b, and a height difference H2 is formed between the occlusion structure 20 and the outer sheath 10 in the radial direction J, thus ensuring the stability of the occlusion structure 20 along the catheter sheath 100. Figure 9 During the withdrawal of blood vessel 200 in the direction indicated by the middle arrow X, the puncture hole 201 intercepts the rear end 21 of the sealing structure 20 so that the sealing structure 20 can be smoothly detached from the outer sheath 10 and accumulate in the puncture hole 201. After the catheter sheath 100 is completely withdrawn from blood vessel 200, the puncture hole 201 is sealed to achieve automated hemostasis.

[0057] In some examples, the water-soluble structure 30 is made of a water-soluble polymer. This polymer can dissolve rapidly or gradually in bodily fluids such as blood, and can dissolve on its own after fulfilling its supporting function, thus avoiding interference with the detachment of the sealing structure 20 from the outer sheath 10 and preventing long-term interference with blood vessels. Because water-soluble polymers have good biocompatibility, they can avoid triggering immune responses, inflammation, or other adverse reactions during dissolution, thereby ensuring patient safety. After the water-soluble structure 30 dissolves, its products can be eliminated through normal metabolic pathways, further reducing potential impacts on the vascular environment. Furthermore, water-soluble polymers have good processability, facilitating the fabrication of the water-soluble structure 30 into structural forms suitable for specific application requirements. For example, the water-soluble structure 30 can be precisely coated onto the distal end 11 of the outer sheath 10 using one of the following processes: dip coating, spray coating, or brush coating, enabling it to form an effective temporary support structure during deployment. The processability of water-soluble polymer materials supports the above coating process, enabling the water-soluble structure 30 to be uniformly attached to the distal end 11 of the outer sleeve 10 in the form of a thin film or coating.

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

[0059] In some examples, the occlusion structure 20 is made of a biodegradable polymer material. The biodegradable properties of this polymer material allow the occlusion structure 20 to fit tightly against the puncture site 201 after detaching from the outer sheath 10, effectively preventing blood leakage and achieving reliable postoperative hemostasis. Furthermore, the occlusion structure 20 is gradually absorbed by the body, eliminating the need for a second surgery and reducing patient pain and risk. After vascular occlusion, the occlusion structure 20 gradually degrades within the body and is cleared through normal metabolic pathways, avoiding potential long-term effects on blood vessels or surrounding tissues, and exhibits good biocompatibility and mechanical properties.

[0060] Specifically, biodegradable polymeric materials include at least one of natural polymeric materials and synthetic polymeric materials. Natural polymeric materials are derived from natural resources, possess excellent biocompatibility and biodegradability, and their degradation products are typically non-toxic substances that can be metabolized normally by the human body. Synthetic polymeric materials, through molecular structure design, allow for flexible control of the material's degradation rate, mechanical strength, and other functional properties. Both can be used individually or in combination to meet the performance requirements of the occlusion structure 20 in different scenarios, ensuring that it provides sufficient occlusion support while avoiding long-term residual effects on blood vessels through degradation after the occlusion task is completed.

[0061] In some examples, both natural and synthetic polymers exhibit good processability, facilitating the fabrication of the sealing structure 20 into structural forms suitable for specific application requirements. For instance, the sealing structure 20 can be precisely coated onto the distal end 11 of the outer sleeve 10 or the outer side of the water-soluble structure 30 using a process such as dip coating, spraying, or brushing. The processability of both natural and synthetic polymers supports these coating processes, enabling the sealing structure 20 to adhere uniformly to the distal end 11 of the outer sleeve 10 or the outer side of the water-soluble structure 30 in the form of a thin film or coating, thereby meeting specific sealing functional requirements.

[0062] The natural polymer materials include at least one of gelatin, collagen, cellulose, starch, and chitosan; the synthetic polymer materials include 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 plugging structure 20 in the radial direction J is 300 to 600 μm.

[0064] See 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 in the radial direction J is formed between the plugging structure 20 and the outer sheath 10, and the height difference H1 corresponds to the thickness of the water - soluble structure 30a. This height difference H1 enables the plugging structure 20 to smoothly separate from the outer sheath 10 during the withdrawal of the catheter sheath 100 from the blood vessel 200, thus preventing the plugging structure 20 from being taken out of the body with the outer sheath 10. Through the height difference H1, it is ensured that the plugging structure 20 accumulates at the puncture hole 201 after the water - soluble structure 30a is dissolved, achieving reliable postoperative hemostasis.

[0065] See Figure 2 , Figure 4 , Figure 7 and Figure 9 As shown, when the water - soluble structure 30b is completely dissolved, a height difference H2 in the radial direction J is formed between the plugging structure 20 and the outer sheath 10, and the height difference H2 corresponds to the thickness of the plugging structure 20 itself. This height difference H2 also ensures that the plugging structure 20 can naturally separate from the outer sheath 10 during withdrawal and smoothly accumulate at the puncture hole 201, achieving postoperative hemostasis. In addition, the height difference H2 also provides a sufficient thickness for the plugging structure 20 to effectively seal the puncture hole 201 and prevent blood leakage, further improving the reliability of hemostasis.

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

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

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

[0069]

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

[0071] For example, when the outer tube 10 has a size of 10F, its outer circumference x = 10mm. Substituting this into equation (1), we can obtain:

[0072]

[0073] Similarly, when the outer tube 10 has a size of 15F, its outer circumference x = 15mm. Substituting this into equation (1), we can obtain:

[0074]

[0075] As can be seen from the above calculations, the length of the sealing structure 20 increases linearly with the increase of the size of the outer tube 10, but the ratio of the length to the area of ​​the tube opening of the outer tube 10 remains consistent, ensuring that the sealing structure 20 can reliably seal the puncture hole 201.

[0076] For example, in some examples, at the distal end 11 of the outer sleeve 10, a sealing structure 20 is first coated by dip coating, and the material of the sealing structure 20 is gelatin. Then, a 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 sealing 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, at the distal end 11 of the outer sleeve 10, a sealing structure 20 is first applied by spraying, and the material of the sealing structure 20 is polylactic acid. Then, a water-soluble structure 30 is applied 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 sealing 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 sealing structure 20 is larger than the area of ​​the distal end of the outer tube 10; the larger area of ​​the sealing structure 20 ensures that the sealing structure 20 completely covers the puncture hole 201, and the larger area of ​​the sealing structure 20 can provide additional safety margin. Even if there is a small gap between the sealing structure 20 and the puncture hole 201, the larger coverage area of ​​the sealing 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 sealing 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 sealing structure 20, and parameter A2 is the area of ​​the distal end of the outer sleeve 10;

[0082] The area of ​​the sealing structure 20 is calculated as follows (3):

[0083] A1=x*l (3)

[0084] Wherein, parameter A1 is the area of ​​the sealing structure 20, parameter x is the outer perimeter of the outer sleeve 10, and parameter l is the length of the sealing 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 (4):

[0086]

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

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

[0089] A1 = x * l = 10 × 0.8 = 8.00 m²

[0090] According to equation (4):

[0091]

[0092] Therefore, A1>A2, which satisfies the requirement of equation (2).

[0093] The above are merely specific embodiments of this disclosure, but the scope of protection of this disclosure is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the scope of the technology disclosed in this disclosure should be included within the scope of protection of this disclosure. Therefore, the scope of protection of this disclosure should be determined by the scope of the claims.

Claims

1. A catheter sheath with postoperative hemostatic function, characterized in that, include: An outer sleeve, a sealing 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 sealing structure; The water-soluble structure is disposed radially between the outer sheath and the sealing structure, or the water-soluble structure is disposed on one side of the sealing structure in the direction of withdrawal of the blood vessel from the outer sheath; When the water-soluble structure dissolves in the blood, a radial height difference is formed between the sealing structure and the outer sheath, so that the sealing structure detaches from the outer sheath when the outer sheath is withdrawn from the blood vessel; The water-soluble structure is partially covered by the sealing structure, forming a portion exposed outside the sealing structure; the portion of the water-soluble structure exposed outside the sealing structure extends along the direction in which the outer cannula withdraws from the blood vessel to form an exposed section; or The rear end of the sealing structure along the direction of withdrawal from the blood vessel via the outer sheath is connected to the front end of the water-dissolving structure along the direction of withdrawal from the blood vessel via the outer sheath.

2. The catheter sheath with postoperative hemostasis function according to claim 1, 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.

3. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that, The thickness of the water-soluble structure and the sealing structure in the radial direction is 300 to 600 μm.

4. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that, The length of the sealing structure along the axial direction of the outer sleeve satisfies the following formula (1): （1） Among them, parameters The length of the sealing structure along the axial direction of the outer sleeve, parameter This refers to the outer circumference of the outer sleeve.

5. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that, The area of ​​the sealing structure is larger than the area of ​​the distal end of the outer sleeve. The area of ​​the sealing structure and the area of ​​the distal end of the outer sleeve satisfy the following formula (2): （2） Among them, parameters The area of ​​the sealing structure, parameter The area of ​​the distal end of the outer sleeve; The area of ​​the sealing structure is calculated using the following formula (3): （3） Among them, parameters The area of ​​the sealing structure, parameter The outer perimeter of the outer sleeve is given by the parameter. The length of the sealing structure along the axial direction of the outer sleeve; The area of ​​the distal end of the outer sleeve is calculated using the following formula (4): （4） Among them, parameters The area of ​​the distal end of the outer sleeve, parameter The outer circumference of the outer sleeve.

6. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that, The material of the water-soluble structure is a water-soluble polymer.

7. The catheter sheath with postoperative hemostasis function according to claim 6, characterized in that, The water-soluble polymeric material includes at least one of polyacrylamide, polyacrylic acid, polyvinylpyrrolidone, polyvinyl alcohol, polymaleic anhydride, polyquaternary ammonium salt, and polyethylene glycol.

8. The catheter sheath with postoperative hemostasis function according to claim 1, characterized in that, The sealing structure is made of biodegradable polymer material.

9. The catheter sheath with postoperative hemostasis function according to claim 8, characterized in that, The biodegradable polymeric material includes at least one of natural polymeric materials and synthetic polymeric materials.

10. The catheter sheath with postoperative hemostasis function according to claim 9, characterized in that, The natural polymeric 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-co-hydroxyacetic acid copolymer.

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