Vascular hemostasis device

Abstract

The present application provides a kind of vascular hemostasis device, it is related to medical equipment technical field, to solve the risk of existing hemostasis device in a certain extent after hemostasis is completed and needs to be taken out for hemostasis expansion part, there is later rebleeding.The vascular hemostasis device provided by the present application, including conveying assembly, hemostasis assembly and release assembly;Conveying assembly includes conveying pipe and conveying guide wire, conveying pipe is formed with accommodating space, hemostasis assembly is received in accommodating space, one end of conveying guide wire is inserted into conveying pipe, and is connected with hemostasis assembly, can push or pull back hemostasis assembly in accommodating space;Conveying guide wire is made of conductive material, release assembly includes releaser and irrelevant negative electrode, the end of conveying guide wire away from hemostasis assembly is connected with the positive electrode of releaser.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical equipment, in particular to a blood vessel hemostasis device. BACKGROUND

[0002] As an important technical means in the field of modern medicine, the development of interventional therapy is inseparable from the progress of imaging technology. Since the advent of digital subtraction angiography (DSA) technology in the 1970s, vascular interventional therapy has gradually become one of the main treatment methods for cardiovascular diseases, cerebrovascular diseases and tumors. This technology establishes a treatment channel through a puncture point with a diameter of only 2-3 mm, significantly reducing the large-area tissue trauma caused by traditional open surgery.

[0003] During the implementation of vascular interventional surgery, the guide wire and catheter system as the core instrument bear the key role of establishing a treatment channel. According to clinical statistical data, about 15%-20% of vascular interventional surgeries are accompanied by different degrees of blood vessel injury complications, including blood vessel perforation, dissection formation, etc. To deal with such complications, the first generation of blood vessel hemostasis device adopts an inflatable balloon technology to achieve hemostasis effect through temporary compression. However, this temporary device has a high risk of rebleeding after withdrawal, with an incidence rate of 7%-12%, and once rebleeding occurs, it will seriously endanger life.

[0004] Therefore, there is an urgent need to provide a blood vessel hemostasis device to solve the problems existing in the prior art to some extent. SUMMARY

[0005] The purpose of the present application is to provide a blood vessel hemostasis device to solve the problem that the existing hemostasis device needs to remove the expansion part used for hemostasis after hemostasis is completed, and there is a risk of rebleeding later.

[0006] The blood vessel hemostasis device provided by the present application comprises a delivery assembly, a hemostasis assembly and a release assembly; the delivery assembly comprises a delivery tube and a delivery guide wire, the delivery tube forms an accommodation space inside, the hemostasis assembly is accommodated in the accommodation space, one end of the delivery guide wire penetrates into the delivery tube and is connected with the hemostasis assembly, and the delivery guide wire can push or pull back the hemostasis assembly into or out of the accommodation space; the delivery guide wire is made of a conductive material, and the release assembly comprises a releaser and an irrelevant negative electrode, and one end of the delivery guide wire away from the hemostasis assembly is connected with the positive electrode of the releaser.

[0007] Among them, the hemostasis assembly comprises a stent and an elastic film, the elastic film is wrapped outside the stent, and the stent is made of a memory alloy.

[0008] Specifically, the stent is a cylindrical tubular structure, the delivery guide wire is a plurality of delivery guide wires, and the plurality of delivery guide wires are arranged at intervals along the circumference of the stent and connected with the stent.

[0009] Further, the stent comprises a first end support, a second end support and a plurality of support strips; the first end support and the second end support are both circular, the delivery guide wire is connected with the second end support, and the plurality of support strips are arranged between the first end support and the second end support in a cross arrangement to form a grid structure.

[0010] Further, the plurality of support strips are arranged in a wave shape; the peaks of the support strips connected with the first end support are connected with the first end support, the valleys of the support strips connected with the second end support are connected with the second end support, the peaks of the support strips in the middle are connected with the valleys of the support strips in the layer above, and the valleys of the support strips are connected with the peaks of the support strips in the layer below.

[0011] The stent is provided with a developing assembly, and the developing assembly is distributed along the circumference of the stent.

[0012] Specifically, the developing assembly comprises a first developing element and a second developing element, the first developing element is arranged at the end of the stent away from the end of the stent connected with the delivery guide wire, and the second developing element is arranged at the end of the stent connected with the delivery guide wire.

[0013] Further, the first developing element and the second developing element are both a plurality of developing elements, the plurality of first developing elements are uniformly arranged at the edge of the end of the stent away from the delivery guide wire along the circumference of the stent, and the plurality of second developing elements are uniformly arranged at the edge of the end of the stent connected with the delivery guide wire along the circumference of the stent.

[0014] The blood vessel hemostasis device provided by the application further comprises a developing ring arranged at the receiving and releasing end of the delivery tube.

[0015] Specifically, the outer wall of the elastic film carries a drug layer, and the drug layer is used for hemostasis.

[0016] Compared with the prior art, the blood vessel hemostasis device provided by the application has the following advantages:

[0017] The blood vessel hemostasis device provided by the application comprises a delivery assembly, a hemostasis assembly and a release assembly; the delivery assembly comprises a delivery tube and a delivery guide wire, the delivery tube is formed with a containing space, the hemostasis assembly is accommodated in the containing space, one end of the delivery guide wire penetrates into the delivery tube and is connected with the hemostasis assembly, and the delivery guide wire can push or pull back the hemostasis assembly in the containing space; the delivery guide wire is made of conductive material, and the release assembly comprises a releaser and an irrelevant negative electrode, and one end of the delivery guide wire away from the hemostasis assembly is connected with the positive electrode of the releaser.

[0018] According to the analysis, the hemostasis assembly can be accommodated in the delivery tube of the delivery assembly, and the hemostasis assembly can be pulled back or pushed out of the containing space formed by the delivery tube through the delivery guide wire; during operation, the hemostasis assembly is accommodated in the containing space, the delivery tube is moved in the blood vessel by the delivery guide wire until the position where hemostasis is needed, then the hemostasis assembly is pushed out of the containing space by the delivery guide wire, and the hemostasis assembly expands after being pushed out, thereby achieving the purpose of hemostasis of the damaged blood vessel.

[0019] When the hemostasis assembly expands stably, the releaser can be powered on; since the delivery guide wire in the application is made of conductive material, the position where the delivery guide wire is connected with the hemostasis assembly will be gradually fused after being powered on, thereby realizing the separation of the delivery guide wire and the hemostasis assembly, and finally, the delivery guide wire and the delivery tube are synchronously pulled out, thereby completing the hemostasis operation of the blood vessel; since the hemostasis assembly remains in the position of the damaged blood vessel, the problem of re-damage will not occur in the later period, thereby ensuring the treatment effect. BRIEF DESCRIPTION OF DRAWINGS

[0020] In order to more clearly illustrate the specific embodiments of the application or the technical solutions in the prior art, the drawings needed in the following specific embodiments or prior art description will be briefly introduced. Obviously, the drawings in the following description are some embodiments of the application, and other drawings can also be obtained by those skilled in the art without creative labor.

[0021] Figure 1 The structure schematic diagram of the blood vessel hemostasis device provided by the embodiment of the application in a released state is shown in the figure;

[0022] Figure 2 The structure schematic diagram of the hemostasis assembly in the blood vessel hemostasis device provided by the embodiment of the application is shown in the figure;

[0023] Figure 3 The structure schematic diagram of the stent in the blood vessel hemostasis device provided by the embodiment of the application is shown in the figure;

[0024] Figure 4 The structure schematic diagram of the blood vessel hemostasis device provided by the embodiment of the application in a contained state is shown in the figure.

[0025] In the figure: 1 - delivery tube; 101 - containing space; 102 - developing ring; 2 - delivery guide wire; 3 - hemostatic assembly; 301 - stent; 3011 - first end support; 3012 - second end support; 3013 - support strip; 4 - elastic film; 5 - first developing member; 6 - second developing member. DETAILED DESCRIPTION

[0026] In order to make the objects, technical solutions and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application and are not all the embodiments. The components of the embodiments of the present application described and shown in the drawings can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the claimed present application, but only represents selected embodiments of the present application. Based on the embodiments of the present application, all other embodiments obtained by those skilled in the art without creative work fall within the scope of the present application.

[0027] In the description of the embodiments of the present application, it should be noted that the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inner", "outer" and the like indicate the orientation or positional relationship based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the product of the present application is usually placed, and are only for the convenience of describing the present application and simplifying the description, and do not indicate or imply that the indicated device or element must have a particular orientation, be constructed and operated in a particular orientation, and therefore cannot be understood as limiting the present application. In addition, the terms "first", "second", "third" and the like are only used for differentiation in description and cannot be understood as indicating or implying relative importance.

[0028] In addition, the terms "horizontal", "vertical" and the like do not mean that the components must be absolutely horizontal or vertical, but can be slightly inclined. For example, "horizontal" only means that it is more horizontal relative to "vertical", and does not mean that the structure must be completely horizontal, but can be slightly inclined.

[0029] In the description of the embodiments of the present application, it should also be noted that, unless otherwise explicitly specified and limited, the terms "arrangement", "installation", "communication", "connection" should be understood broadly, for example, can be fixedly connected, can be detachably connected, or integrally connected; can be mechanically connected, can be electrically connected; can be directly connected, can be indirectly connected through an intermediate medium, or can be the communication between two elements inside. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0030] As used herein, the term "and / or" includes any and all combinations of one or more of the associated items.

[0031] For ease of description, spatial relationship terms such as "on", "upper", "under", and "lower" can be used herein to describe the relationship between one element and another element as shown in the drawings. Such spatial relationship terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the drawings.

[0032] The terminology used herein is for the purpose of describing various examples only and is not intended to be limiting of the present disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has", "having" as used herein, are specifically intended to be construed as open-ended terms i.e., the inclusion of unspecified features, numbers, operations, components, elements, and / or combinations thereof, but not the exclusion of any other features, numbers, operations, components, elements, and / or combinations thereof.

[0033] Due to manufacturing techniques and / or tolerances, variations of the shapes illustrated in the drawings can occur. Therefore, the examples described herein are not limited to the specific shapes illustrated in the drawings, but include variations of the shapes that occur as a result of manufacturing processes.

[0034] Features of the examples described herein can be combined with features of other examples as will be apparent after review of the disclosure of the present application. Also, although a variety of examples have been described with reference to the embodiment in which they are particularly useful, other configurations are possible. Further, various embodiments can be combined in different combinations than the ones described, but will not be understood to be outside the scope of the application as claimed.

[0035] As shown in the drawings, Figures 1-4 The present application provides a vascular hemostasis device, which comprises a delivery assembly, a hemostasis assembly 3 and a release assembly; the delivery assembly comprises a delivery tube 1 and a delivery guide wire 2, the delivery tube 1 is formed with a containing space 101, the hemostasis assembly 3 is accommodated in the containing space 101, one end of the delivery guide wire 2 penetrates into the delivery tube 1 and is connected with the hemostasis assembly 3, so as to push or pull back the hemostasis assembly 3 in the containing space 101; the delivery guide wire 2 can be made of conductive material, and can be equipped with the release assembly comprising a releaser and an irrelevant anode, and the end of the delivery guide wire 2 away from the hemostasis assembly 3 is connected with the anode of the releaser.

[0036] Compared with the prior art, the vascular hemostasis device provided by the present application has the following advantages:

[0037] The blood vessel hemostasis device provided by the application can accommodate the hemostasis assembly 3 through the delivery tube 1 in the delivery assembly, and can retract or push the hemostasis assembly 3 out of the accommodation space 101 formed by the delivery tube 1 through the delivery guide wire 2. During operation, the hemostasis assembly 3 is accommodated in the accommodation space 101, the delivery guide wire 2 is used to drive the delivery tube 1 to move in the blood vessel until the position where hemostasis is needed, then the hemostasis assembly 3 is pushed out of the accommodation space 101 by the delivery guide wire 2, and the hemostasis assembly 3 expands after being pushed out, thereby achieving the purpose of hemostasis of the damaged blood vessel.

[0038] When the hemostasis assembly 3 expands stably, the release assembly can be powered, and since the delivery guide wire 2 in the application is made of conductive material, the position where the delivery guide wire 2 is connected with the hemostasis assembly 3 will gradually melt after being powered, thereby realizing the separation of the delivery guide wire 2 and the hemostasis assembly 3, and finally, the delivery guide wire 2 and the delivery tube 1 are synchronously extracted, thereby completing the hemostasis operation of the blood vessel. Since the hemostasis assembly 3 remains in the position of the damaged blood vessel, the problem of re-damage in the later period does not occur, thereby ensuring the treatment effect.

[0039] It can be understood that by arranging the hemostasis assembly 3 in the accommodation space 101, the problem that the hemostasis assembly 3 expands and expands when it has not reached the predetermined position, thereby affecting the treatment effect, can be avoided.

[0040] It should be noted that when the hemostasis assembly 3 reaches the predetermined position and completes the hemostasis of the blood vessel, the release device generates a weak direct current, usually 1mA-5mA, the delivery guide wire 2 is powered with a positive electrode, and a corresponding unrelated negative electrode can be attached to the skin of the patient's leg or other position. Since the current is very small, it will not cause damage to the human body. A complete loop is formed through the delivery guide wire 2 and the unrelated negative electrode.

[0041] Since the delivery guide wire 2 in the application is made of conductive material, usually stainless steel, and blood is an electrolyte solution, when direct current is applied, an electrolytic reaction occurs, causing the anode to corrode, thereby achieving the melting of the delivery guide wire 2, and further achieving the disconnection between the delivery guide wire 2 and the hemostasis assembly 3.

[0042] Optionally, as shown in Figure 2 The hemostasis assembly 3 in the application includes a stent 301 and an elastic membrane 4, the elastic membrane 4 is wrapped outside the stent 301, and the stent 301 is made of memory alloy.

[0043] The stent 301 made of memory alloy can expand after releasing the accommodation space 101, thereby driving the elastic membrane 4 to expand, thereby achieving the hemostasis of the damaged blood vessel.

[0044] It can be understood that the stent 301 in the application is a super-elastic stent 301 made of nickel-titanium super-elastic alloy. Since the stent 301 and the elastic film 4 both have a certain elasticity, when the stent 301 drives the elastic film 4 to expand and still cannot better compensate for the damaged blood vessel, the stent 301 and the elastic film 4 can be retracted into the containing space 101 by using the delivery guide wire 2 again. After adjusting to a new position through the delivery tube 1 and the delivery guide wire 2, the hemostatic assembly 3 is released again until it can completely cover the damaged blood vessel to complete hemostasis, and then the delivery guide wire 2 and the delivery tube 1 are removed by power.

[0045] Alternatively, as shown in Figure 2 , the stent 301 in the application is a cylindrical tubular structure, and the delivery guide wire 2 is in multiple pieces and is arranged in a circumferential direction of the stent 301 and connected with the stent 301.

[0046] Preferably, the delivery guide wire 2 in the application is in three pieces, and the three delivery guide wires 2 are uniformly distributed in the circumferential direction of the stent 301, so as to realize stable output and retraction of the stent 301.

[0047] Of course, when the stent 301 gradually expands after being pushed out of the output tube, the three delivery guide wires 2 will also open up following the expansion of the stent 301, forming the state shown in Figure 1 .

[0048] Alternatively, as shown in Figure 2 in combination with Figure 3 , the stent 301 in the application includes a first end support 3011, a second end support 3012, and a plurality of support bars 3013; the first end support 3011 and the second end support 3012 are both circular, the delivery guide wire 2 is connected with the second end support 3012, and the plurality of support bars 3013 are arranged between the first end support 3011 and the second end support 3012 and are arranged in a cross manner to form a grid structure.

[0049] The first end support 3011 and the second end support 3012 can provide a support basis for the support bars 3013 arranged in the middle, and the plurality of support bars 3013 arranged in a cross manner to form a grid structure can provide a basis for expansion and contraction of the stent 301.

[0050] Preferably, as shown in Figure 2 in combination with Figure 3 , the plurality of support bars 3013 in the application are arranged in a wave shape; the wave crest of the support bar 3013 connected with the first end support 3011 is connected with the first end support 3011, the wave trough of the support bar 3013 connected with the second end support 3012 is connected with the second end support 3012, the wave crest of the support bar 3013 arranged in the middle is connected with the wave trough of the support bar 3013 arranged in the upper layer, and the wave trough is connected with the wave crest of the support bar 3013 arranged in the lower layer.

[0051] Further preferably, as shown in the drawings, the stent 301 in the application is provided with a developing assembly, and the developing assembly is distributed along the circumference of the stent 301. Figure 2

[0052] Through the developing assembly arranged on the stent 301, the position of the stent 301 in the blood vessel can be monitored in real time, so that the stent 301 can be stopped and inflated accurately at the position where hemostasis is needed, the adjustment process is reduced, and the operation efficiency is improved.

[0053] Preferably, as shown in the drawings, the developing assembly in the application includes a first developing piece 5 and a second developing piece 6, the first developing piece 5 is arranged at one end of the stent 301 away from the end where the stent 301 is connected with the delivery guide wire 2, and the second developing piece 6 is arranged at the end where the stent 301 is connected with the delivery guide wire 2. Figure 2

[0054] In fact, the first developing piece 5 is arranged on the first end support 3011, and the second developing piece 6 is arranged on the second end support 3012, so that the axial size of the stent 301 can be determined, the size and position of the whole hemostasis assembly 3 can be determined, and the accuracy of the hemostasis position can be ensured.

[0055] Further preferably, as shown in the drawings, the first developing piece 5 and the second developing piece 6 in the application are both multiple, and the multiple first developing pieces 5 are uniformly arranged along the circumference of the stent 301 at the edge of the end of the stent 301 away from the delivery guide wire 2; and the multiple second developing pieces 6 are uniformly arranged along the circumference of the stent 301 at the edge of the end of the stent 301 connected with the delivery guide wire 2. Figure 2 The multiple first developing pieces 5 and the multiple second developing pieces 6 arranged along the circumference can make the developing of the stent 301 more three-dimensional, and since the first developing piece 5 and the second developing piece 6 are arranged on the circumference of the stent 301, even if the stent 301 rotates, it will not disappear on the instrument, so that the clarity of the developing is ensured, and the accuracy of the operation is further ensured.

[0056] Optionally, as shown in the drawings, the vascular hemostasis device provided by the application further includes a developing ring 102, and the developing ring 102 is arranged at the receiving and releasing end of the delivery tube 1.

[0057] Figure 4 By arranging the developing ring 102 at the receiving and releasing end of the delivery tube 1, the position of the delivery tube 1 can be accurately positioned, so that the position after the output of the hemostasis assembly 3 is ensured to be accurate, and the problem of affecting the operation efficiency due to multiple adjustments is reduced.

[0058] The above-mentioned receiving and releasing end refers to the end of the delivery tube 1 at which the hemostasis assembly 3 can be extended and retracted.

[0059] The above-mentioned receiving and releasing end refers to the end of the delivery tube 1 at which the hemostasis assembly 3 can be extended and retracted.

[0060] ​​​Preferably, the outer wall of the elastic film 4 in the application carries a drug layer, the drug is a hemostatic drug, used for hemostasis; the inner wall is also provided with a five-layer drug for inhibiting intimal hyperplasia, used for preventing in-stent restenosis after stent implantation.

[0061] The drug layer in the application is a hemostatic drug layer, through the drug layer carried by the outer wall of the elastic film 4, the hemostatic drug can be used to hemostasis at the blood vessel injury site after the expansion of the hemostatic assembly 3, and the hemostasis speed is accelerated, and the treatment effect is improved.

[0062] It should be noted here that the length of the stent 301 in the application in the axial direction is 5-30 mm. In actual operation, first, the path of the break in the patient's blood vessel is confirmed by imaging, then the delivery tube 1 is inserted into the blood vessel and pushed to the injury site, multi-angle positioning is performed, the position of the delivery tube 1 is confirmed to be able to fully cover the blood vessel break, then the delivery guide wire 2 is used to resist the hemostatic assembly 3, and the delivery tube 1 is gradually retracted, so that the hemostatic assembly 3 can be gradually released, and the stent 301 gradually expands and expands under the action of temperature to block the injury site of the blood vessel. The first imaging member 5 and the second imaging member 6 are used to monitor the position of the hemostatic assembly 3, when the position is not accurate, the hemostatic assembly 3 is retracted into the delivery tube 1 by using the delivery guide wire 2, the position of the delivery tube 1 is adjusted again by using the imaging ring 102, and after accurate, the hemostatic assembly 3 is released again, when the hemostatic assembly 3 expands and covers the blood vessel break, the bleeding stops, and the hemostatic assembly 3 can be recovered after the local thrombus of the break is firm, so that the problem of blocking the blood vessel caused by placing the instrument in the blood vessel can be avoided, but when necessary, such as bleeding after the hemostatic assembly 3 is recovered, the hemostatic assembly 3 can be sent to the corresponding position, and the delivery assembly and the hemostatic assembly 3 are separated by melting the delivery guide wire 2 by using the release device, and the hemostasis of the injury site is completed.

[0063] It should be further noted here that the elastic film 4 in the application can be made of PTFE (polytetrafluoroethylene), which can deform under the action of the stent 301 to achieve hemostasis of the blood vessel.

[0064] The above only describes the preferred embodiments of the application and should not be used to limit the application. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the application should be included in the protection scope of the application.

Claims

1. A vascular hemostasis device, characterized in that, Includes delivery components, hemostasis components, and release components; The delivery assembly includes a delivery tube and a delivery guide wire. A receiving space is formed inside the delivery tube, and the hemostatic assembly is housed in the receiving space. One end of the delivery guide wire passes through the delivery tube and is connected to the hemostatic assembly, enabling the hemostatic assembly to be pushed out or pulled back into the receiving space. The delivery guidewire is made of conductive material, and the release assembly includes a release device and an unrelated negative electrode. The end of the delivery guidewire away from the hemostasis assembly is connected to the positive electrode of the release device. The hemostatic component includes a stent and an elastic membrane, the elastic membrane covering the stent, and the stent being made of a shape memory alloy; The support is a cylindrical tubular structure, and there are multiple conveying guide wires, which are spaced apart along the circumference of the support and connected to the support. The bracket includes a first end support, a second end support, and multiple support bars; Both the first end support and the second end support are circular. The conveying guide wire is connected to the second end support. Multiple support bars are located between the first end support and the second end support and are arranged in a cross pattern to form a grid structure. All of the aforementioned support bars are arranged in a wave-like pattern; The crest of the support strip connected to the first end support is connected to the first end support, the trough of the support strip connected to the second end support is connected to the second end support, the crest of the middle support strip aligns with the trough of the support strip above, and the trough aligns with the crest of the support strip below.

2. The vascular hemostasis device according to claim 1, characterized in that, The support is provided with developing components, which are distributed circumferentially along the support.

3. The vascular hemostasis device according to claim 2, characterized in that, The developing assembly includes a first developing element and a second developing element. The first developing element is disposed at the end of the support away from the support and connected to the transport guide wire, and the second developing element is disposed at the end of the support connected to the transport guide wire.

4. The vascular hemostasis device according to claim 3, characterized in that, There are multiple first developing elements and multiple second developing elements, and the multiple first developing elements are evenly arranged along the circumference of the bracket at the edge of the bracket away from the conveying guide wire; Multiple second developing elements are evenly arranged along the circumference of the support at the edge of the end where the support is connected to the transport guide wire.

5. The vascular hemostasis device according to claim 1, characterized in that, It also includes a developing ring, which is disposed at the inlet and outlet ends of the delivery tube.

6. The vascular hemostasis device according to claim 1, characterized in that, The outer wall of the elastic membrane is loaded with a drug layer, which is used for hemostasis.

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