WO2024007921A1

WO2024007921A1 - Implantable access device and fluid circulation system

Info

Publication number: WO2024007921A1
Application number: PCT/CN2023/103427
Authority: WO
Inventors: 李祥海
Original assignee: 上海心光生物医药有限责任公司
Priority date: 2022-07-05
Filing date: 2023-06-28
Publication date: 2024-01-11

Abstract

Disclosed herein are an implantable access device and a fluid circulation system. The implantable access device comprises: a first access port comprising a self-sealing component that allows the entrance of a needle for extracting or injecting a fluid during the treatment; and a first communication component and a second communication component that are separately communicated with the first access port and are configured for providing a fluid circulation path for a fluid inward or outward from the first access port. Depending on the characteristic attributes of the first communication component and the second communication component, the flow resistance in the first communication component is greater than the flow resistance in the second communication component.

Description

Implantable access devices and fluid circulation systems

Technical field

The present application relates to the technical field of medical devices, and in particular to an implantable access device and a fluid circulation system.

Background technique

For patients with kidney disease, when the kidney function drops to a certain level, for example, to 10% of the normal level, the patient with kidney disease needs to undergo hemodialysis to remove metabolites from their blood. Hemodialysis is performed by filtering blood through a dialysis device, which is a time-consuming process.

In order to ensure that blood can flow back into the body at a high flow rate, an arteriovenous graft (AVG) is usually implanted in kidney disease patients through surgery before hemodialysis. The arteriovenous graft is connected to the patient's arteries and veins. During hemodialysis, external tubing is connected to the arteriovenous graft through two dialysis needles to provide blood flow pathways from and to the dialysis device.

However, this method will also bring some problems. One situation is that long-term blood rushing into the veins at high pressure and high speed will cause neointimal hyperplasia in the veins, thereby hindering the venous flow, and even blocking the veins, causing the blood flow path to disappear. Another situation is that during the treatment phase, blood is withdrawn from and returned to the body in an arteriovenous graft, resulting in reflux, which means that the blood returned to the body directly flows out without a path for blood circulation in the body. It is taken out of the body again, which makes hemodialysis inefficient. In addition, during the non-treatment stage, due to the existence of arteriovenous grafts, part of the blood will also circulate through the arteriovenous grafts, which causes the blood flow that should flow to the distal parts of the human body (such as arms, hands, etc.) to be shunted , resulting in steal syndrome.

In view of the various problems caused by the above-mentioned arteriovenous grafts, one way is to add an actuating device to the arteriovenous graft, and use the actuating device to actuate the circulation channel of the arteriovenous graft to open or Closed during non-treatment phases. However, this method still relies on the original arteriovenous graft structure and also requires a dialysis needle to penetrate the arteriovenous graft. This requires the operator to be a professional with skilled medical processing capabilities and is not suitable for home use scenarios. Moreover, the sealing of the arteriovenous graft during the non-treatment stage will cause the blood to stop flowing inside it, which may easily lead to blood clotting.

Another approach is to implant ports in arteries and veins. These ports usually contain a chamber plugged with a self-sealing material. A catheter extends from the chamber and is surgically implanted into the corresponding artery and vein respectively. A port can then be used to The blood flows out for dialysis, while the other port is used to return blood to the body. In the case where the two ports are implanted in the artery and vein in an independent manner, it will either lead to too many and complicated ports that need to be connected during the surgery, or it will cause the ports to cause blood clotting during the non-treatment stage. In the case where the two ports are connected to the artery and vein, although a needle insertion port is provided for easy operation, However, since the two ports are connected, various problems caused by the above-mentioned arteriovenous grafts will also occur.

Contents of the invention

In view of the above-mentioned shortcomings of related technologies, the purpose of this application is to provide an implantable access device and fluid circulation system to reduce complications and complicated operations caused by traditional arteriovenous grafts.

In order to achieve the above objects and other related objects, the first aspect of this application discloses an implantable access device. The implantable access device includes: a first access end, including a self-sealing member, and the self-sealing member Allowing the needle to enter to extract or inject fluid during the treatment phase; a first communication member and a second communication member, respectively connected to the first access end, for providing a fluid flow path to or from the first access end; Wherein, depending on the characteristic properties of the first communication member and the second communication member, the flow resistance of the first communication member is greater than the flow resistance of the second communication member.

A second aspect of the present application discloses an implantable access device, which includes: a second communication section that allows a needle to enter to extract or inject fluid during a treatment phase; the second communication section allows the needle to enter The entering part is the first access end; the first communication section is connected to one end of the second communication section to form a fluid flow path; wherein, depending on the characteristic attributes of the first communication section and the second communication section , the flow resistance of the first communication section is greater than the flow resistance of the second flow section.

The third aspect of this application discloses a fluid circulation system, including an implantable access device as disclosed in any embodiment of the first aspect and the second aspect of this application; an external pipeline device, including a lead-out pipeline and a return pipeline , the lead-out pipeline is used to connect one access end of the implantable access device, the return pipeline is used to connect the other access end; the purification device is connected to the lead-out pipeline and the output The return pipeline is used to purify the fluid output by the lead-out pipeline and output it to the return pipeline.

To sum up, the implantable access device and fluid circulation system proposed in this application can effectively reduce the aforementioned arterial blood stealing and venous bleeding by arranging connecting components with different flow resistances on both sides of the access end. Hyperplasia, thrombosis and other complications, and can reduce reflux phenomenon and improve blood purification efficiency. Furthermore, the different flow resistances of the connecting components of this application are determined based on the characteristic attributes of the designed connecting components, and do not require additional operations on other objects. In this way, the structure is simple and easy to use, and can be suitable for hospital treatment. and family therapy.

Description of the drawings

The specific features of the invention to which this application relates are set forth in the appended claims. The features and advantages of the invention to which this application relates can be better understood by reference to the exemplary embodiments described in detail below and the accompanying drawings. A brief description of the drawings is as follows:

Figure 1 shows a schematic architectural diagram of an implantable access device in an embodiment of the present application.

Figure 2 shows that in an implantable access device according to an embodiment of the present application, the flow resistance of the first communication member is greater than that of the second communication member. Architectural diagram of flow resistance of components.

FIG. 3 is a schematic structural diagram of an implantable access device according to an embodiment of the present application, in which the flow resistance of the first communication member is greater than the flow resistance of the second communication member.

FIG. 4 shows a schematic structural diagram of an implantable access device according to an embodiment of the present application in which the flow resistance of the first communication member is greater than the flow resistance of the second communication member.

FIG. 5 shows a specific structural diagram of an implantable device in an embodiment of the present application.

FIG. 6 is a schematic cross-sectional structural diagram of the implantable device in the embodiment shown in FIG. 5 of the present application.

FIG. 7 is a schematic diagram of the disassembled structure of the implantable device of the present application in the embodiment shown in FIG. 5 .

Figure 8 shows a specific structural diagram of the first access terminal in an embodiment of the present application.

Figures 9 and 10 respectively show schematic diagrams of the implantable access device connected to blood vessels in different embodiments of the present application.

Figure 11 shows a schematic architectural diagram of an implantable access device in an embodiment of the present application.

Figure 12 shows a specific structural schematic diagram of an implantable access device in an embodiment of the present application.

FIG. 13 is a schematic diagram of the disassembled structure of the implantable device in the embodiment shown in FIG. 12 of the present application.

Figure 14 shows a schematic architectural diagram of an implantable access device in an embodiment of the present application.

FIG. 15 is a schematic cross-sectional view of A-A in the embodiment shown in FIG. 14 .

Figure 16 shows a schematic diagram of an implantable access device connected to a blood vessel in an embodiment of the present application.

Figure 17 shows a schematic diagram of the third communication member including two conduits and connecting blood vessels in an embodiment of the present application.

FIG. 18 shows a schematic diagram of the connecting components of the implantable access device connected to blood vessels through end-to-side anastomosis and end-to-end anastomosis respectively in one embodiment of the present application.

Figure 19 shows a schematic structural diagram of a fluid circulation system in an embodiment of the present application.

Detailed ways

The following describes the implementation of the present application through specific embodiments. Those familiar with this technology can easily understand other advantages and effects of the present application from the content disclosed in this specification.

In the following description, reference is made to the accompanying drawings, which illustrate several embodiments of the application. It is to be understood that other embodiments may be utilized and mechanical, structural, electrical, and operational changes may be made without departing from the spirit and scope of the present disclosure. The following detailed description should not be considered limiting, and the scope of embodiments of the present application is limited only by the claims of the published patent. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application. Spatial terms such as "up", "down", "left", "right", "below", "below", "Lower,""upper,""upper," etc., may be used herein to facilitate describing the relationship of one element or feature to another element or feature illustrated in the figures.

Although in some instances the terms first, second, etc. are used herein to describe various elements or parameters, these elements or parameters should not be limited by these terms. These terms are only used to distinguish one element or parameter from another element or parameter. For example, a first access end may be termed a second access end, and similarly, a second access end may be termed a first access end, without departing from the scope of the various described embodiments. The first access end and the second access end both describe one access end, but are not the same access end unless the context clearly indicates otherwise. Similar situations also include a first communication member and a second communication member, or a first communication member and a second communication member.

Furthermore, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context indicates otherwise. It should be further understood that the terms "comprising" and "including" indicate the presence of stated features, steps, operations, elements, components, items, categories, or/and groups, but do not exclude one or more other features, steps, operations, The presence, occurrence, or addition of an element, component, item, category, or/and group. The terms "or" and "or/and" as used herein are to be construed as inclusive or to mean any one or any combination. Therefore, "A, B or C" or "A, B or/and C" means "any of the following: A; B; C; A and B; A and C; B and C; A, B and C" . Exceptions to this definition occur only when the combination of elements, functions, steps, or operations is inherently mutually exclusive in some manner.

Before hemodialysis, patients with kidney disease are surgically implanted with arteriovenous grafts placed under the skin and made of biocompatible materials. The biocompatible material can be, for example, the fluoropolymer polytetrafluoroethylene (PTFE) or Materials such as polyether urethane (PEU). Typically, a hemodialysis access is formed by an arteriovenous graft placed/buried under the skin of the patient's leg, arm, or chest, with one end connected to a selected artery and the other end connected to a selected vein. In hemodialysis, in order to connect the patient to the dialysis equipment, the needle portion of two large hypodermic needles/puncture needles are inserted through the skin into an arteriovenous graft. Blood is drawn from the patient through one needle and passed through the dialysis The device circulates and returns to the patient through a second needle. Typically, patients undergo hemodialysis three days a week for about three to four hours a day.

Long-term placement of arteriovenous grafts in the human body will cause some complications, including arterial blood steal, venous hyperplasia, graft thrombosis, etc. Arterial steal occurs when excessive blood flow "steals" blood from the distal artery through the arteriovenous graft/pathway connecting the artery and vein; arterial steal prevents the appropriate blood supply from reaching The patient's limbs.

The venous hyperplasia is due to the fact that the blood flowing through the arteriovenous graft usually reaches a turbulent flow rate. Then, this fast-flowing blood will enter the connected veins. The collision of the blood flow with the veins will lead to the development of endomysium hyperplasia, thus It causes thickening of vein walls and narrowing of blood vessels, thereby impeding venous flow. In more severe cases, it can cause blood clotting, resulting in graft thrombosis.

The graft thrombosis is a blood clot that forms due to stasis/cessation of blood flow through the graft is called a graft thrombus. Graft thrombosis remains one of the recurring complications associated with the use of arteriovenous grafts.

In addition, during the treatment of patients with arteriovenous grafts, reflux can occur as blood is pumped out of and back into the body within an arteriovenous graft. The reflux phenomenon means that the blood returned to the body is directly pumped out of the body again through the arteriovenous graft without access to the blood circulation in the body, which will lead to low efficiency of blood purification.

In view of the above problems, this application proposes an implantable access device and a fluid circulation system, which can effectively reduce the aforementioned arterial blood stealing, venous hyperplasia, It can prevent complications such as thrombosis, reduce reflux, and improve blood purification efficiency. Furthermore, the different flow resistances of the connecting components of this application are determined based on the characteristic attributes of the designed connecting components, and do not require additional operations or intervention by other objects. In this way, the structure of this application is simple and easy to use, and can It is suitable for various modes and medical scenarios such as hospital treatment and home treatment.

In some embodiments, the present application proposes an implantable access device. For example, the implantable access device can be used as an infusion port for inflow and infusion of drugs or other liquids, or can be used as an infusion port, for example. The dialysis port is used for blood purification and hemodialysis, and can also be applied to arteriovenous fistula (AVF) surgical scenarios, such as arteriovenous fistula treatment applications/scenarios that are commonly used for long-term hemodialysis vascular access. It should be understood that the arteriovenous fistula refers to the abnormal channel between the artery and the venous system that diverts blood from the normal capillary bed; or, the existence of an abnormal channel between the artery and the vein is called an arteriovenous fistula. In order to facilitate the explanation of the embodiments of the present application, a scenario in which the implantable access device of the present application is suitable for hemodialysis will be used as an example for description below. This should not be construed as a limitation of the present application.

The implantable access device of this application is suitable for hemodialysis scenarios, can increase the convenience of puncture, can reduce the learning cost of medical staff, especially home users, and can reduce the occurrence of reflux, especially during non-treatment Under certain conditions, it can reduce arterial theft and blood vessel proliferation, reduce the risk of blood vessel stenosis, and thereby increase service life.

Please refer to Figure 1, which is a schematic architectural diagram of an implantable access device in an embodiment of the present application. As shown in the figure, the implantable access device 1 includes a first access terminal 10, a first connection member 11, and the second communication member 12. The first communication member 11 and the second communication member 12 respectively communicate with the first access end 10 and are used to provide a fluid flow path to or from the first access end 10 . The first access end 10 includes a self-sealing member 100 that allows entry of a needle (e.g., needle penetration into the self-sealing member) by means of which fluid can be extracted or delivered during the treatment phase, e.g. The inserted needle can withdraw fluid from or deliver fluid to the first access end 10 .

The communication member in any of the foregoing and subsequent embodiments is a structure with a communication function, and may, for example, include a tubular structure of at least one conduit. It will be understood that "conduit" as disclosed in this application refers to components that can be fluidly coupled to each other to provide a path for transferring fluids (ie, saline, blood, or plasma, etc.) between the components. "Guide" used in this way "Tube" broadly includes a tube, pipe, hose, conduit, or other structure having one or more lumens adapted to convey fluid between two ends. Typically, a tube is an elongated cylinder with some flexibility shape structure, but the geometry and rigidity can vary. In some embodiments, multiple components can also be joined by physical proximity, become an overall unitary structure, or be formed from the same piece of material.

The communication member (can also be understood as the conduit it includes) in any of the foregoing and subsequent embodiments can be configured as an artificial blood vessel. The artificial blood vessel can be, for example, an artificial blood vessel made of polymer material, or it can be, for example, a biological artificial blood vessel. The polymer materials include polyethylene (PE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester (also known as polyester fiber, PET), polyether urethane ( PEU), and polyurethane (PU), etc. The biological artificial blood vessels can also be called bioengineered tissue conduits, which refer to blood vessels prepared using extracellular matrix, such as acellular artificial blood vessels (Human Acellular Vessels, HAV) or skeleton acellular artificial blood vessels (Skeletal Acellular Vessels). , SAV). In other embodiments, each communication member may also be configured as an animal or human blood vessel, or the like. It should be noted that each communication component can also be set to different types. For example, the communication component used to connect to blood vessels can be set to artificial blood vessels, animal or human blood vessels, etc., and the communication components are only used to connect between the access ends. Medical silicone rubber materials, elastomer rubber materials (soft TPU), resin materials, or PTFE materials that can be implanted into the human body can also be used. For example, in the subsequent embodiments shown in Figures 11 to 13, the second communication member 12 The third communication member 13 can be configured as an artificial blood vessel, an animal or a human blood vessel, etc. The first communication member 11 can be made of silicone rubber material, elastomer rubber material (soft TPU), resin material, or PTFE material. In this way, the implant can be ensured. The treatment effect of the implantable access device is improved while reducing the cost.

Wherein, depending on the characteristic properties of the first communication member 11 and the second communication member 12 , the flow resistance of the first communication member 11 is greater than the flow resistance of the second communication member 12 . The flow resistance refers to the ratio of the pressure difference at both ends of the flow path to the linear velocity of the fluid. In other words, the flow resistance can represent the movement resistance/viscosity of the fluid in the flow path; for example, relatively speaking, the fluid When the fluid flows through conduit A, the movement resistance is small, and when the fluid flows through conduit B, the movement resistance is large. This means that the flow resistance of conduit A is smaller than that of conduit B. In one embodiment of the present application, the flow resistance of the first communication member 11 is greater than the flow resistance of the second communication member 12 , for example, it means that when the blood circulates in the first communication member 11 , the movement resistance is greater than that of the blood in the second communication member. 12 Movement resistance during circulation. For example, when the pipeline is in a "series" relationship, the flow resistance of the fluid flowing through the "series" pipeline is equal to the sum of the flow resistances of each segmented flow tube; for another example, when the pipeline is in a "parallel" relationship When , the reciprocal of its flow resistance is equal to the sum of the reciprocal flow resistances of each branch pipe.

The characteristic attributes of the connected component refer to the surface appearance and inherent properties or inherent characteristics of the connected component under natural conditions, such as the shape, structure, size, color, material, etc. of the connected component. That is to say, the flow resistance of the first communication member is greater than the flow resistance of the second communication member, which is determined by the characteristic attributes of the designed communication member and does not require external control.

To be more precise, "external control" mentioned in this application, here, the external control refers to other objects that operate to cause the connected component to change its characteristic attributes. The other objects refer to the design of the connected component other than the connected component itself. Other objects, such as operators, actuating devices, etc. For example, in the prior art patent documents with publication numbers US20060229548A1 and CN1374877A, it is mentioned that active intervention measures are used to achieve changes in the flow resistance of the pipeline. These The methods are all external control methods. For example, the patent document US20060229548A1 discloses an arterial interventional valve device system. Based on the traditional AVG, a valve device is added to the arterial end of the artificial blood vessel. The valve device includes a magnetic piston. When the magnetic field When placed near the valve assembly, the piston moves to open the valve. When no treatment is being performed, the piston is normally closed, thus preventing or minimizing arterial theft. Although it can intervene in the flow resistance in the pipeline through external control, in its scheme, the blood sealed inside the blood vessel remains , it is easy to cause coagulation; in addition, its solution also increases the difficulty of operation for medical staff, which is especially unfavorable for home medical scenarios.

In one embodiment, the flow resistance of the first communication member is greater than the flow resistance of the second communication member in that the pipeline cross-sectional area of the first communication member is smaller than the pipeline cross-sectional area of the second communication member. It should be noted that the shape of the connecting member may not be uniform. Therefore, the pipe cross-sectional area of the first connecting member is smaller than the pipe cross-sectional area of the second connecting member. It only needs that the minimum pipe cross-sectional area of the first connecting member is smaller than the second connecting member. The minimum pipeline cross-sectional area can realize the design of different flow resistance. Please refer to FIG. 2 , which is a schematic structural diagram in which the flow resistance of the first communication member is greater than the flow resistance of the second communication member in an implantable access device according to an embodiment of the present application. As shown in the figure, the first communication member 11 and the second communication member 12 are uniform tubular structures and are arranged in a circular tubular structure. The inner diameter of the pipeline of the first communication member 11 is smaller than the inner diameter of the pipeline of the second communication member 12, that is, the pipeline cross-sectional area of the first communication member 11 is smaller than The pipe cross-sectional area of the second communication member 12, for example, the pipe inner diameter ratio of the first communication member 11 and the second communication member 12 can be set to any ratio from 1/2 to 1/8, for example, it can be set to 1/ 2, 1/4, 1/6, 1/8. In the example of setting to 1/4, the inner diameter of the pipe of the first communication member 11 is set to 2 mm, for example, and the inner diameter of the pipe of the second communication member 12 is set to 8 mm, for example. For example, the inner diameter of the pipe of the first communication member 11 can be set to any value from 1 to 3 mm, for example, 1 mm, 2 mm, 3 mm, and the inner diameter of the pipe of the second communication member 12 can be set to any value from 6 mm to 8 mm. , for example, 6mm, 7mm, 8mm. Of course, other shape and size designs can also be used to achieve the pipe cross-sectional area requirements, and this application is not limited here.

In one embodiment, the flow resistance of the first communication member is greater than the flow resistance of the second communication member by: the first communication member includes a flow resistance structure disposed in its pipe. In one example, the flow resistance structure may be, for example, a convex structure disposed in the pipe. The convex structure increases the flow resistance in the pipe. The convex structure may protrude inward from the inner wall of the pipe. It can also be a structural component fixed on the inside of the pipeline. Please refer to Figure 3, which shows that in an implantable access device of the present application, the flow resistance of the first communication member is greater than that of the second communication member. Schematic diagram of the flow resistance structure, as shown in the figure, The inner diameters of the pipes of the first communication member 11 and the second communication member 12 are substantially equal, and a protruding structure 110 is provided inside the pipe of the first communication member 11 . In another example, the flow resistance structure includes a one-way flow valve structure, for example, such as a one-way valve, a Tesla valve, etc. In another example, the flow resistance structure includes a bidirectional flow valve structure, which is not limited in this application.

In one embodiment, the flow resistance of the first communication member is greater than the flow resistance of the second communication member. The pipe of the first communication member is configured as a curved conduit to increase the flow resistance of the fluid in the pipe. For example, it is configured as S-shaped or corrugated duct. Please refer to FIG. 4 , which is a schematic structural diagram of an implantable access device according to an embodiment of the present application in which the flow resistance of the first communication member is greater than the flow resistance of the second communication member. As shown in the figure, the first communication member 11 is designed as a corrugated conduit and the second communication member 12 is kink-free or kink-resistant.

As shown in FIG. 1 , the first access end 10 refers to a part for injecting or extracting fluid. The following is an exemplary description of the specific structure that the first access terminal 10 can adopt with reference to FIGS. 5 to 8 .

Please refer to FIGS. 5 to 7 . FIG. 5 is a schematic diagram showing the specific structure of the implantable device in one embodiment of the present application. FIG. 6 is a cross-section of the implantable device in the embodiment shown in FIG. 5 . Structural schematic diagram, FIG. 7 shows a disassembled structural schematic diagram of the implantable device of the present application in the embodiment shown in FIG. 5 . The first access end 10 of the implantable device 1 includes a self-sealing member 100 and an end body 101 . The end body 101 is provided with an inner cavity 1010 (also called a chamber), a first flow port 1011, a second flow port 1012, and an access port 1013. The first flow port 1011, the second flow port 1012, and the access port 1013 communicate with each other through the inner cavity 1010. Among them, the first flow port 1011 is also connected to the first communication member 11 , the second flow port 1012 is also connected to the second communication member 12 , and the access port 1013 is used to set the self-sealing member 100 .

In one embodiment, as shown in Figures 5 and 7, the end body 101 is configured as a hexahedral structure, and further uses a radian angle transition between adjacent surfaces, so that the outer corners of the end body 101 are arc-shaped surfaces. The overall texture is relatively smooth and not easy to irritate human skin. In addition, it is easier to clean and disinfect, reducing the chance of bacterial growth.

In one embodiment, as shown in Figures 5 and 7, a limiting structure 1015 can be provided on the end body 101. The limiting structure 1015 is used to fix the end body 101 in the human body. For example, a doctor uses the limiting structure 1015 to fix the end body 101 in the human body. The main body 101 is fixed on the tissue of the human body. In one example, the limiting structures 1015 are configured as ear holes formed at the corners of the bottom surface of the end body 101. In the example where the end body 101 is configured as a hexahedral structure, the limiting structures 1015 can be configured as four corners corresponding to the four corners of the bottom surface. an ear hole. Those skilled in the art can also design the limiting structure 1015 into other structures or shapes based on the inspiration of this application, and this application does not limit this.

In one embodiment, as shown in FIG. 6 , the first flow opening 1011 and the second flow opening 1012 are arranged oppositely, for example, formed on opposite surfaces of the end body 101 , and the inner cavity 1010 is arranged to flow from the second flow opening in the end body 101 . Port 1012 flows to the first The port 1011 forms a transition channel with increasing flow resistance and smooth surface. Among them, the increasing flow resistance means that the flow resistance increases according to a certain rule, which means that the flow resistance increases gradually rather than suddenly. In this way, providing a transition channel transition between the first communication member 11 and the second communication member 12 with different flow resistances can avoid blood retention caused by uneven blood flow and avoid blood coagulation.

Further, in an example in which the inner diameter of the pipe passing through the first communication member 11 is smaller than the inner diameter of the second communication member 12 so that the flow resistance of the first communication member 11 is greater than the flow resistance of the second communication member 12 , the transition channel is configured such that the inner wall is In this way, even if the flow rate of the fluid from the second communication member 12 is too fast, it can spirally flow along the conical surface in the transition channel to avoid coagulation caused by blood retention. In addition, due to the conical surface type, The circulation surfaces of the channels are all circular, which will make the pressure of the end body 101 evenly distributed, reduce the pressure and damage to the patient's local obstruction, and reduce the risk of infection and complications.

In one embodiment, as shown in FIG. 5 , the left and right side walls of the end body 101 conforming to the direction from the second flow port 12 to the first flow port 11 are configured to have arcuate surfaces corresponding to the shape of the inner cavity 1010 . In this way, compared with the setting plane, redundant parts on the end body 101 are removed, maximizing the flow channel of the inner cavity 1010 with the smallest volume, and reducing the volume occupied inside/outside the patient's body.

In order to facilitate connection with the first communication member and the second communication member, in one embodiment, the first access end further includes a first connection mechanism and a second connection mechanism. As shown in FIGS. 6 and 7 , the first connection mechanism 103 connects the first flow port 1011 and the first communication member 11 so that the first communication member 11 communicates with the first flow port 1011 , and the second connection mechanism 104 The second flow port 1012 and the second communication member 12 are connected so that the second communication member 12 communicates with the second flow port 1012 . Among them, the first connection mechanism 103 and the second connection mechanism 104 are respectively fixed on the end body 101 at positions corresponding to the first flow opening 1011 and the second flow opening 1012. For example, the first communication member 11 and the second communication member 12 may be respectively bonded to the first connection mechanism 103 and the second connection mechanism 104 by adhesion (for example, medical glue or patches). , the first communication member 11 and the second communication member 12 can also be mechanically fixed by using the structural design of each connecting mechanism, or the first connecting member 11 and the second connecting member 12 can be further connected by using the structural design of the connecting mechanism after bonding. 12 Mechanical fixation.

In one embodiment, as shown in Figure 6, the first connection mechanism 103 has a first connection channel 1030, and the second connection mechanism 104 has a second connection channel 1040. In order to prevent the first connection channel 1030 from being connected to the first flow port 1010 and When there is blood retention or unsmooth circulation at the connection between the second connection channel 1040 and the second flow port 1012, the connection channels (1030, 1040) and their corresponding flow ports (1010, 1012) are connected smoothly, as shown in Figure As shown in 6, a curved surface is provided at the joint between the first connection channel 1030 and the first flow port 1010, and a curved surface is provided at the joint between the second connection channel 1040 and the second flow port 1012.

As shown in FIG. 7 , in one embodiment, the first connection mechanism 103 includes a first connecting part 1032 and a first fixing part 1031 . The first connector 1032 extends outward corresponding to the first flow port on the end body 101 and is used to cover the first communication member 11 , that is, the first communication member 11 can cover its port on the first connector 1032 . The first fixing part 1031 cooperates with the first connecting part 1032 to fix the first communication member 11 on the first connecting part 1032. For example, the first fixing member 1031 and the first connecting member 1032 may be matched in a manner including clamping, snapping, threaded fit, or a combination of any of the above, which is not limited in this application.

Please refer to Figure 8 in conjunction with Figure 6. Figure 8 shows a specific structural schematic diagram of the first access end in an embodiment of the present application. The self-sealing component of the first access end is omitted in Figure 8. In the embodiment shown in FIGS. 6 and 8 , the first connecting member 1032 includes a screwing part 1032a and a connecting part 1032b. External threads are provided on the outer peripheral surface of the screwing portion 1032a for screwing the first fixing member 1031. The connecting portion 1032b is formed by continuing to extend along the screwing portion 1032a. The connecting portion 1032b is used to sleeve the first communication member 1011. As shown in FIG. 6 , the first communication member 1011 is sleeved on the connection part 1032b. After the first fixing member 1031 is screwed on the screwing part 1032a, the first communication member 1011 will be clamped on the connection part 1032b. In order to prevent the first communication member 1011 from falling off the connection portion 1032b, further, a protruding structure 1032c can be provided on the outer periphery of the connection portion 1032b. When the first communication member 1011 is sleeved on the connection portion 1032b, it can be raised. The structure 1032c is stuck and cannot directly slide away from the connecting portion 1032b in the transverse direction.

In one embodiment, as shown in FIGS. 6 and 7 , the first fixing member 1031 is provided with a portion (not labeled) that matches the screwing portion 1032 a and the connecting portion 1032 b of the first connecting member 1032 . When the connecting member 1011 is sleeved on the connecting part 1032b, the first fixing member 1031 passes through the first connecting member 1011 and is rotated and screwed on the screwing part 1032a by means of the internal thread matching the screwing part 1032a. Since the screwing part is not connected with the screwing part 1032a, The contact of the first communication member 1011 will not cause damage to the first communication member 1011 and avoid side blood leakage or thrombosis. Furthermore, an end surface of the first fixing member 1031 away from the end body 1010 has a resisting portion 1031a, as shown in FIG. The first communication member 11 sleeved on the first connector 1032 is pressed against the end surface of the first connector 1032 so that the internal channel of the first communication member 11 is flush with the connection channel 1030 of the first connector 1032 . That is to say, the abutment portion 1031a can ensure a smooth connection between the internal channel of the first communication member 11 and the connecting channel 1030 of the first connecting piece 1032 without any sudden change in flow resistance or path, and can further avoid the occurrence of sudden changes in the channel. The phenomenon of blood retention and coagulation occurs.

In one embodiment, the second connection mechanism 104 is configured to have a similar structure to the first connection mechanism 103. The difference is only in size, shape, or position, etc., and the principle and cooperation method are basically the same as the first connection mechanism 103, for example , when the inner diameter of the pipe passing through the first communication member 11 is smaller than the inner diameter of the second communication member 12 , the flow resistance of the first communication member 11 is large. In the example of the flow resistance of the second communication member 12 , the size of the second connection mechanism 104 needs to be adapted to the second communication member 12 . As shown in FIG. 7 , the second connection mechanism 104 may include a second connection part 1042 and a first fixing part 1041 . The second connecting piece 1042 is formed on the end body 101 and extends outward corresponding to the second flow opening, and is used to cover the second communication member 12 . The second fixing part 1041 cooperates with the second connecting part 1042 to fix the second communication member 12 on the second connecting part 1042. For example, the way in which the second fixing part 1041 and the second connecting part 1042 cooperate may also include clamping, snapping, threading, or a combination of any of the above ways. In a specific example, the structure and cooperation method adopted by the second fixing part 1041 and the second connecting part 1042 can be seen in Figures 6 to 8 and the embodiments related to the first fixing part 1031 and the first connecting part 1041 The description will not be repeated here. Of course, in other embodiments, the second connection mechanism 104 can also be provided with a different structure from the first connection mechanism 103, and this application is not limited thereto.

In one embodiment, the end body 101, the first connecting mechanism 103 and the second connecting mechanism 104 are configured as an integrally formed structure. Further, in an embodiment in which the first connection mechanism 103 includes a first fixing part and a first connecting part, and the second connection mechanism 104 includes a second fixing part and a second connecting part, as shown in Figures 7 and 8, The end body 101 and the first connecting piece 1032 of the first connecting mechanism 103 and the second connecting piece 1042 of the second connecting mechanism 104 are configured as an integrally formed structure.

In one embodiment, the end body 101 is configured to be made of metal materials, including stainless steel, copper, aluminum, titanium, and composites thereof. For example, the composites of titanium include titanium alloys. Preferably, the end body 101 is made of titanium alloy or stainless steel. In another embodiment, the end body 101 is configured to be made of polymer materials, including polycarbonate (PC), polypropylene (PP), polyethylene (PE), polytetrafluoroethylene (PTFE), etc. , among which, polycarbonate and polypropylene need to be used for medical purposes. Of course, the end body 101 can also be made of a composite of metal materials and polymer materials, or partially made of metal materials and partially made of polymer materials. This application does not limit this, such as other materials with certain rigidity.

As mentioned above, in some embodiments, the end body 101 and the first connection mechanism 103 and the second connection mechanism 104 can be configured as an integrally formed structure. In view of this, the first connection mechanism 103 and the second connection mechanism 104 are integrated with the end body 101 . The integrally formed part of the body 101 may be configured to be made of the same material as the end body 101 .

In one embodiment, an anticoagulant coating is provided in the first access end to prevent blood coagulation. For example, the anticoagulant coating can be coated on the wall of the inner cavity 1010 as shown in Figure 5, and can further be coated on the connection channel 1030 of the first connection mechanism and the connection channel 1040 of the second connection mechanism. The anticoagulant coating may be an inert anticoagulant coating or an active anticoagulant coating. Inert anticoagulant coatings, such as phosphorylcholine coatings, inhibit the activation of the coagulation system by reducing plasma protein adsorption and blood cell adhesion on the surface. Active anticoagulant coatings, such as heparin coatings, activate antithrombin in the blood to inhibit the activity of thrombin and coagulation factors, thereby blocking the coagulation reaction.

In order to further ensure the sealing performance of the implantable device, in one embodiment, a sealing coating is provided at the connection between each communication member and the first access end. The sealing coating is, for example, a silicone coating or a fluoropolymer coating. For example, after each communication member is connected to the first access end, a sealing coating can be applied on the outside of the connection, or the partial mechanism or structure in which each communication member is connected to the first access end can be Apply seal coat and continue applying seal coat after complete connection.

Please continue to refer to FIGS. 5 to 7 . In one embodiment, the access port 1013 is located on the upper surface of the end body 101 , and can be disposed through the upper wall of the end body 101 (the upper wall is the corresponding upper surface of the end body 101 The hole structure formed by the side wall) penetrates the upper wall of the end body 101 so that the hole structure communicates with the inner cavity 1010. The self-sealing member 100 is disposed in the hole structure. In this way, the needle-piercing self-sealing member 100 can extend into the inner cavity 1010. . In a specific example, the upper surface of the end body 101 is square, and the access port 1013 is an inscribed circle of the square on the upper surface. Such a design can provide the largest circular surface on the access end as the area for needle penetration. , convenient for doctors or patients to puncture. Of course, in other examples, the upper surface of the end body 101 can also be set in other shapes, such as a rectangle to maximize the puncture area. It should be understood that being square or rectangular means that it is roughly square or rectangular, and does not necessarily mean that it is a standard square or rectangular shape.

The self-sealing component 100 is disposed in the access port 1013. The self-sealing component 100 refers to a structure formed of a biocompatible, self-resealing/self-sealing penetrable material. The self-sealing member 100 allows needle penetration to communicate with the first access end 10 (eg, the lumen 1010 of the end body 101 ) so that fluid can be withdrawn from or delivered to the first access end 10 10. The self-sealing member 100 reseals the hole formed by inserting the needle when the needle is withdrawn, and thereby prevents fluid from being released or overflowing from the interior of the first access end 10 (eg, the lumen 1010). The material of the self-sealing component of the present application is made of a stretchable material suitable for repeated punctures. For example, the self-sealing component can be made of silicone material, rubber material, latex material, or polymer material. During treatment, the needle is inserted into the self-sealing component, the treatment is completed, and the self-sealing component can achieve self-sealing after the dialysis needle is removed. The needle may have a beveled end to create a perforation in the self-sealing member to facilitate its easier "healing" or sealing. In various embodiments, the self-sealing member 100 may have a thickness of between about 1 mm and about 5 mm, or between about 1 mm and about 10 mm.

In one embodiment, the self-sealing component 100 is disposed in the access port 1013 by injection molding. For example, the material used for the self-sealing component 100 is directly injected into the access port 1013 for molding. In this way, the assembly can be completed during molding. The process is simple and ensures the sealing and stability of the access end.

In one embodiment, the self-sealing component 100 is disposed in the access port 1013 in an assembled manner. For example, the self-sealing component 100 is produced independently and then inserted into the access port 1013. In this way, a more complex structure can be produced and has flexibility. .

In one embodiment, as shown in FIGS. 6 and 7 , the inner wall of the hole structure corresponding to the access port 1013 is in the form of a conical surface. Further, a groove 1014 is provided on the upper wall of the end body 101 around the hole structure, and the self-sealing member 100 has a structure corresponding to the groove 1014. Adaptable protrusions (not shown) prevent the self-sealing member 100 from disengaging from the access opening 1014 .

In some embodiments, the needle used to penetrate the self-sealing member 100 may also be referred to as a dialysis needle. In embodiments, the needle may be a puncture needle, a straight needle, a curved needle, a butterfly needle, or the like. Preferably, the needle can be a curved needle, which can prevent the needle from being accidentally dragged and separated from the self-sealing component during use. For example, the needle of the needle can be a 16-gauge needle or a 17-gauge needle with an inner hole diameter of 1.19mm, which can also adapt to the required blood flow speed. For example, the needle is a 16-gauge needle with an inner diameter of 1.19mm, which is suitable for To allow higher blood flow rates, such as 300cc/min. But it is not limited to this. In practical applications, different types of needles can be selected according to the patient's condition.

In order to prevent the needle from penetrating the self-sealing member 100 into the inner cavity 1010 and then further penetrating the end body 101, in one embodiment, the first access end 10 may also include a shell (not shown) that prevents the needle from being penetrated. ), the outer shell may be formed of a material with certain rigidity, so as to be puncture-resistant or anti-puncture relative to the needle during hemodialysis. It should be understood that the outer shell particularly refers to the bottom surface portion opposite to the needle penetration surface. In other embodiments, a rigid structure may also be provided on the inner wall of the inner cavity 1010 of the first access end 10 (especially the bottom surface opposite the needle penetration surface) to prevent the needle from penetrating the access end. Of course, in an example where the end body 101 has a certain degree of puncture resistance or puncture resistance due to the selection of its own material, a shell or rigid structure to prevent puncture may not be provided. For example, in an example where the end body 101 is made of metal material , since the metal material has a certain rigidity and can prevent being punctured by needles, there is no need to provide a shell or a rigid structure.

As mentioned above, a needle can be used to penetrate the self-sealing member to communicate with the first access end, thereby injecting or withdrawing fluid into the first access end. However, in some embodiments, more than one access port may need to be implanted in the patient's body. The inlet end is used to form a flow path for the fluid. The aforementioned and subsequent access ends are either used for injecting fluid or for extracting fluid. In order to avoid incorrect insertion by the operator, for example, the access end used for injecting fluid Insert the needle for extraction, or insert the access end for fluid extraction into the needle for delivery. Therefore, in some embodiments, each access end mentioned above is also provided with a needle entry identifier, which is used to prompt the fluid flow direction of the access end or to distinguish the access end as a venous access end. or arterial access. Wherein, the fluid flow direction refers to the direction in which the fluid enters or leaves the human body through the access end. When the fluid enters the human body through the access end, it can be called injection or input. The fluid leaves the human body through the access end. direction, may be called extraction or extraction. Or, the needle entry mark is used to indicate whether the access end is a venous access end or an arterial access end, so as to facilitate the operator to perform the puncture operation and reduce the error rate of the operation.

In some examples, the needle entry mark is represented by the size, shape, position, or softness and hardness of the access end. In this way, the operator can observe or touch the access end under the skin and sense its size, shape, Position, or soft and hard, etc. to identify the fluid flow direction it is used for. For example, the access end for extraction is set to a circular structure, and the access end for injection is set to a triangular structure. If the operator touches the circular structure, the needle for extraction can be inserted into the access end. touch If it has a triangular structure, the injection needle can be inserted into the access port. Of course, the shape described is not limited to the above examples, and those skilled in the art can make corresponding deformation designs based on the inspiration of the above examples.

In other examples, the needle entry mark is set as a concave-convex structure close to the skin side of the human body after the access end is implanted in the human body. In this way, the operator can touch the concave-convex structure on the access end under the skin. Sense or determine the direction of fluid flow for which the access port is used. For example, the access end for extraction is provided with a regular concave and convex structure, and the access end for injection is provided with a smooth structure. If the operator touches the access end and senses the concave and convex structure, he can insert the needle for extraction into the interface. Insert the injection needle into the smooth access end.

During the treatment of patients, intelligent devices (such as surgical robots or surgical auxiliary intelligent equipment) can replace manual treatment of patients. In view of this, in some embodiments, the access end is provided with a positioning structure, and the positioning structure is used for positioning The position of the access end on the human body is such that the intelligent device can determine the position of the access end on the human body by identifying the positioning structure, so as to facilitate inserting the needle into the access end. In some examples, the positioning structure is a sensor receiving device disposed on the access end. The sensor receiving device is, for example, an ultrasonic sensor, an electromagnetic sensor, an infrared sensor, etc., so as to facilitate the intelligent device to locate the access terminal. end. Of course, the above are only examples of positioning structures, and this application does not limit them.

The implantable access device in any embodiment of the present application can be used to connect selected blood vessels to form a liquid circulation path. In the application scenario of blood purification such as hemodialysis, the implantable access device connects the selected artery. and selected veins. The implantable access device can also be used to communicate with chambers in the human body. For example, in the application scenario of peritoneal dialysis, the implantable access device communicates with the abdominal cavity to introduce peritoneal dialysis fluid into the abdominal cavity. That is to say, this application does not limit the implantable access device to be used only to connect blood vessels, but can be used to connect any chamber in the body and other parts that need to form a liquid circulation path.

In addition, the implantable access device proposed in any embodiment of the present application can be installed on the patient by means of epidermal implantation or subcutaneous implantation. The subcutaneous implantation refers to burying the entire implantable device under the patient's skin, which does not affect the patient's appearance. The above-mentioned method of implanting on the skin means that the access end of the implantable device or especially the upper surface of the self-sealing component is located on the patient's skin surface. This method can facilitate puncture.

Applicable to different patients or different conditions, there are various situations where the implantable access device is used to connect the distance between two selected blood vessels. In view of this, when the implantable access device connects two selected blood vessels, at least part of the communication member is allowed to bend or stretch to meet the distance requirement between the blood vessels. For example, part of the communication member may be configured as an elastic conduit. When the two selected blood vessels are far apart, the part of the communication member may be stretched after the implantable access device is implanted. When the distance between the two selected blood vessels is very close, after the implantable access device is implanted, this part of the communication member can be bent.

Please refer to Figures 9 and 10, which are respectively schematic diagrams of the implantable access device connected to blood vessels in different embodiments of the present application. In the application scenario of blood purification such as hemodialysis, any one of Figures 1 to 8 can be implemented implantable access Two devices (also called access structures) can be installed and connected to blood vessels in the manner shown in Figure 9 and Figure 10 respectively to form a complete blood circulation circuit. In order to facilitate description and distinction, Figure 9 and The implantable access devices shown in Figure 10 are respectively called a first implantable access device and a second implantable access device. It should be understood that in some application scenarios, only one implantable access device as shown in Figure 9 and Figure 10 can be provided to connect to the patient's blood vessel. Those skilled in the art can choose according to the actual situation of the patient. This application is suitable for patients who need to be implanted. There is no limit on the number of implantable access devices.

As shown in Figure 9, the first implantable access device is used to connect the first blood vessel 20 and the second blood vessel 21, and the first access end 10 of the first implantable access device is used to extract fluid (such as blood) , the second communication member 12 is used to connect the second blood vessel 21 , and the first communication member 11 is used to connect the first blood vessel 20 . As shown in Figure 10, the second implantable access device is used to connect the third blood vessel 22 and the fourth blood vessel 23, and the first access end 10 of the second implantable access device is used to inject fluid (such as blood) , the first communication member 11 is used to connect the third blood vessel 22 , and the second communication member 12 is used to connect the fourth blood vessel 23 . For the structure of the implantable access device provided in FIGS. 9 and 10 , reference may be made to the foregoing description of any one of the embodiments in FIGS. 1 to 8 and related descriptions, and will not be described again here.

In the application scenario of blood purification such as hemodialysis, the first blood vessel 20 connected to the first implantable access device as shown in Figure 9 is a venous blood vessel, and the second blood vessel 21 is an arterial blood vessel, as shown in Figure 10 The third blood vessel 22 connected to the second implantable access device is an arterial blood vessel, and the fourth blood vessel 23 is a venous blood vessel. The arteriovenous blood vessels correspondingly connected to the first implantable access device and the arteriovenous blood vessels correspondingly connected to the second implantable access device may be the same blood vessels or different blood vessels on the body, that is, the third blood vessel 22 and the second blood vessel 22 may be different blood vessels. The second blood vessel 21 may be the same blood vessel or different blood vessels. The fourth blood vessel 23 and the first blood vessel 20 may be the same blood vessel or different blood vessels. Whether they are the same blood vessel may depend on the connection between the two implantable access devices. It can be judged by whether the inserted part has no branches, or it can be judged by whether it is the same part of the body. Taking the judgment based on whether they are the same part of the body as an example, for example, the second blood vessel 21 and the first blood vessel 20 are arterial blood vessels and venous blood vessels in the arm respectively, and the third blood vessel 22 and the fourth blood vessel 23 can be respectively the arm. The arterial blood vessels and venous blood vessels in the chest can also be the arterial blood vessels and venous blood vessels in the chest. This application does not place any restrictions on the position and relationship of the two implantable devices, as long as one access end is used to withdraw fluid, and the other access end can be used to inject fluid.

In an embodiment where two implantable access devices are simultaneously installed in a patient and connected to blood vessels in the manner shown in Figure 9 and Figure 10 to form an extracorporeal fluid circulation pathway during the treatment phase, the input end of the extracorporeal fluid circulation pathway (i.e., the needle used to extract fluid, such as the first needle 30 in Figure 9) is connected to the first access end 10 of the first implantable access device, and the output end of the extracorporeal fluid circulation path (i.e., the needle used to inject fluid A needle, such as the second needle 31 in Figure 10) communicates with the first access end 10 of the second implantable access device. In the application scenario of hemodialysis, the first implantable access device and the second implantable access device are connected between the same arterial blood vessel and the venous blood vessel. In order to perform hemodialysis, the first needle 30 is passed through skin insertion into the first access end 10 of the first implantable access device; insert the second needle 31 through the skin into the first access end 10 of the second implantable access device; as shown in Figure 9 As shown in , the blood enters the first access end 10 through the arterial blood vessel (second blood vessel 21) through the second communication member 12, and is extracted by the first needle 30 (as shown by the arrow S10 in Figure 9) and then enters the dialysis machine equipment; through During the operation of the dialysis machine equipment, waste products are removed from the blood and circulated through the dialysis equipment. Then, as shown in Figure 10, the blood returns to the first access end 10 through the second needle 31, and then enters the venous blood vessel through the second communication member 12 ( The fourth blood vessel 23) is shown as arrow S11 in Figure 10 . Since the second communication members 12 in Figures 9 and 10 are both communication members with small flow resistance, blood can be extracted at a faster flow rate and injected at a faster speed, which greatly reduces the time of hemodialysis. .

When hemodialysis is no longer performed, the needle used for hemodialysis is removed from the implantable access device (ie, non-treatment phase). In the non-treatment phase, the first needle 30 in FIG. 9 When removed, the first implantable access device can form a blood circulation path between the second blood vessel 21 , the second communication member 12 , the first access end 10 , the first communication member 11 , and the first blood vessel 20 , as shown by the dotted arrow S20 in Figure 9. During non-treatment, when the second needle 31 in Figure 10 is removed, the second implantable access device can form blood in the third blood vessel 22, the first communication member 11, the first access end 10, the second The circulation path between the communication member 12 and the fourth blood vessel 23 is as shown by the dotted arrow S21 in FIG. 10 . Since there is a first communication member with a large flow resistance in the implantable access device, in the non-treatment stage and without external control, the amount of flow from the third blood vessel 22 or the second blood vessel 21 through the implantable access device can be reduced. The fluid flow from the access device to the fourth blood vessel 23 or the first blood vessel 20 reduces complications, such as the occurrence of venous hyperplasia. In addition, although the fluid flow is low, it can still ensure that the implanted access device can be used during the non-treatment stage. Provides blood flow to prevent the formation of blood clots within implantable access devices.

As shown in Figure 9 and Figure 10, during the treatment phase, since the two implantable access devices exist independently, reflux will not occur during the treatment phase. In addition, due to the The flow resistance is small, which can ensure that the fluid flows out at a higher speed and is injected at a higher speed, further improving the fluid circulation efficiency. In the non-treatment stage, due to the large flow resistance of the first communication member, the passage between the first implantable access device and the second blood vessel will have greater resistance, causing the first implantable access device to have greater resistance. The flow rate or flow rate in the device is small, so that most of the blood still flows into various parts of the body through the second blood vessel, thus reducing various complications; the second implantable access device also has flow resistance due to the first communication member. If it is large, the second implantable access device will have greater resistance on the passage between the third blood vessel and the fourth blood vessel, causing the flow or flow rate in the second implantable access device to be smaller, so that most of the blood It also flows into various parts of the body from the third blood vessel, thereby reducing various complications.

In one embodiment, please refer to Figure 11, which is a schematic diagram of the architecture of an implantable access device in an embodiment of the present application. As shown in Figure 11, the implantable access device 1 has the architecture shown in Figure 1 On the basis of, it may further include a second access terminal 14 and the third communication member 13. Among them, the first communication member 11 and the third communication member 13 are respectively connected with the second access end 14 .

Since the flow resistance of the first communication member 11 is greater than the flow resistance of the second communication member 12 , in the non-treatment stage, no matter what the relationship between the flow resistance of the third communication member 13 and the first communication member 11 or the second communication member 12 , do not affect the fact that the first communication member 11 will reduce the fluid flow through the implantable access device without external control. Therefore, in some embodiments, depending on the characteristic properties of the first communication member 11 and the third communication member 13 , the flow resistance of the third communication member 13 may be greater than, less than, or equal to the flow resistance of the first communication member 13 .

In order to further increase the flow rate of fluid injection or withdrawal during the treatment phase, in some embodiments, depending on the characteristic properties of the first communication member 11 and the third communication member 13 , the flow resistance of the first communication member 11 is greater than that of the third communication member 13 The flow resistance, that is, the flow resistance of the first communication member 11 in the implantable access device is the largest, so that in the non-treatment stage without external control, the flow rate of fluid flowing through the implantable access device will be Less, and the second communication member 12 and the third communication member 13 for connecting blood vessels have smaller flow resistance than the first communication member 11 respectively, so that fluid can be extracted and injected at a higher flow rate during the treatment phase. Further improve treatment efficiency. It should be understood that in subsequent embodiments, the flow resistance of the first communication member 11 is greater than the flow resistance of the third communication member 13 as an example. This does not mean that the first communication member 11 is necessarily larger than the third communication member 13 .

The functions, structures, materials, shapes, etc. implemented by the third communication member 13 and the second access end 14 may be respectively the same as those described in any of the above-mentioned embodiments in FIGS. 1 to 4 and related descriptions. The second communication component 12 is similar to the first access terminal 10 . Among them, the embodiment in which the flow resistance of the first communication member 11 is greater than the flow resistance of the third communication member 13 can be referred to the embodiment in which the flow resistance of the first communication member 11 is greater than the flow resistance of the second communication member 12. Just add the third communication member 11 to the flow resistance of the second communication member 12. It suffices that the second communication member 12 corresponds to the third communication member 13, which will not be described in detail here in this application.

Please refer to Figures 12 and 13. Figure 12 shows a specific structural schematic diagram of the implantable access device in one embodiment of the present application. Figure 13 shows the implantable device of the present application in the embodiment shown in Figure 12. Schematic diagram of the split structure. For the structures and connection methods of the first communication member 11 , the first access terminal 10 , and the second communication member 12 , please refer to the aforementioned descriptions of FIGS. 5 to 8 . The second access end 14 may also include a self-sealing member 140 and an end body 141 , and may further include a first connection mechanism 143 and a second connection mechanism 144 . The third communication member 13 is connected to the second access end 14 and is further connectable to the second connection mechanism 144 , and the first communication member 11 is connected to the first connection mechanism 143 . Among them, the functions, structures, materials, shapes, etc. implemented or adopted by the self-sealing component 140 of the second access end 14 , the end body 141 , the first connecting mechanism 143 , the second connecting mechanism 144 , and the third connecting member 13 The self-sealing member, the end body, the first connection mechanism, the second connection mechanism, and the second communication member of the first access end described in any of the embodiments of FIGS. 5 to 8 and related descriptions may respectively be similar. , please refer to the description of the foregoing embodiments, which will not be described again in this application.

In some embodiments, such as the implantable access device shown in FIGS. 11 to 13 , the length of the first communication member 11 may be relatively long, and the lengths of the second communication member 12 and the third communication member 13 may be relatively short. Short, in this way, the flow resistance of the first communication member 11 is greater, and it is allowed to be bent when implanted on the patient, thereby better achieving the effect of improving the treatment scene, treatment efficiency, and reducing complications.

In some embodiments, the first communication member 11 may be configured as an elastic conduit, and further, may be configured as a U-shaped conduit. In other words, the first communication member 11 can be U-shaped when the implantable access device is not in use, and is allowed to be stretched to increase the distance at which the implantable access device can connect blood vessels, thereby being suitable for different patients or different conditions. condition. For example, when the two selected blood vessels are far apart, after the implantable access device is implanted, the first communication member 11 can be stretched, further increasing the connectable distance of the implanted access device. When the distance between the two selected blood vessels is very close, after the implantable access device is implanted, the first communication member 11 can be maintained in a U-shaped state to maintain a short connectable distance.

In one embodiment, in the architecture of an implantable access device with two access terminals as shown in FIG. 11 , the first connection component 11 may be configured to connect the first access terminal 10 and the second access terminal 14 The through-hole structure allows the two access ends to be connected or formed together so that they are adjacent and close to each other, thereby meeting the needs or limitations of the patient's physical condition.

Please refer to Figures 14 and 15. Figure 14 shows a schematic architectural diagram of an implantable access device in an embodiment of the present application, and Figure 15 shows a schematic cross-sectional view of A-A in the embodiment shown in Figure 14, wherein Figure 14 and The architecture and structure shown in Fig. 15 are similar to those shown in Figs. 11 to 13. The only difference is that the first communication member 11 can be configured as a through-hole structure connecting the first access end 10 and the second access end 14. The flow resistance provided by the through-hole structure is larger than the second communication member 12 and the third communication member 13 respectively, which can also effectively reduce the aforementioned complications such as arterial blood steal, venous hyperplasia, and thrombus, and can reduce the reflux phenomenon and improve Blood purification efficiency.

In the application scenario of blood purification such as hemodialysis, a complete blood circulation circuit can be formed by simply connecting an implantable access device as shown in any embodiment of FIG. 11 to FIG. 15 to connect a blood vessel. Please refer to Figure 16, which is a schematic diagram of an implantable access device connected to a blood vessel in an embodiment of the present application. The implantable access device shown in any embodiment of Figures 11 to 15 is used to connect the second blood vessel 21 and the first blood vessel 20 , the third communication member 13 is connected to the first blood vessel 20 , the second communication blood vessel 12 is connected to the second blood vessel 21 , and the first communication member 11 is located between the first access end 10 and the second access end 14 between. In this embodiment, the second blood vessel 21 may be, for example, an arterial blood vessel, and the first blood vessel 20 may be, for example, a venous blood vessel. In this case, the second access end 14 is used to inject fluid, and the first access end 10 is used to inject fluid. Aspirate fluid. In an implementation where the second blood vessel 21 is configured as an arterial blood vessel and the first blood vessel 20 is configured as a venous blood vessel, the third communication member 13 may also be used to connect the second blood vessel 21 and the second communication member 12 may be used to connect the first blood vessel 20 , at this time, the first access end 10 is used to inject fluid, and the second access end is used to extract fluid. In other words, the second and third communication members are communication members for connecting blood vessels, thereby enabling the treatment phase An extracorporeal fluid circulation path is formed to form a blood circulation path for fluid from the second blood vessel 21 to the first blood vessel 20 during the non-treatment stage. In view of the fact that the flow resistance of the first communication member in this application is greater than that of the second communication member, therefore, in the non-treatment stage, During the treatment phase, without external control, the fluid flow of blood flowing from the second blood vessel through the implantable access device to the first blood vessel can be reduced. Further, the implantable access device shown in Figures 11 to 15 can connect the first blood vessel and the second blood vessel in the manner of Figure 16, or the method in Figure 16 can be reversed to connect the first blood vessel and the second blood vessel ( That is, the third communication member 13 is connected to the second blood vessel 21, and the second communication blood vessel 12 is connected to the first blood vessel 20). In this way, when the two access ends are used in the treatment stage, the functional changes of injection or extraction are not required. Doctors or patients need to identify which blood vessels should be connected to different connecting components to avoid connection errors and medical accidents.

The following takes the second blood vessel 21 as an arterial blood vessel, the first blood vessel 20 as a venous blood vessel and the connection method shown in Figure 16 as an example to illustrate the blood flow direction. In Figure 16, the first needle 30 is inserted into the first access end 10. The self-sealing member 100 and the second needle 31 pierce the self-sealing member 140 of the second access end 14 so that an extracorporeal fluid circulation path is formed during the treatment phase. In this application, the extracorporeal fluid circulation path refers to a fluid circulation path that leads the fluid inside the body to the outside of the body for processing and then returns it to the body.

As shown in Figure 16, the input end of the extracorporeal fluid circulation pathway (i.e., the needle used to extract fluid, such as the first needle 30 in Figure 16) is connected to the first access end 10, and the output end of the extracorporeal fluid circulation pathway (i.e., the needle used to extract fluid) is connected to the first access end 10. A needle for injecting fluid, such as the second needle 31 in Figure 16) is connected to the second access end 14, thereby connecting the implantable access device between the second blood vessel 21 and the first blood vessel 20. For example, in the application scenario of hemodialysis, the implantable access device is connected between the arterial blood vessel and the venous blood vessel. In order to perform hemodialysis, the first needle 30 is inserted through the skin into the first access end 10; The two needles 31 are inserted into the second access end 14 through the skin; blood enters the first access end 10 through the arterial blood vessel (second blood vessel 21) through the second communication member 12, and the first needle 30 draws out (as shown in Figure 16 (indicated by the arrow in S30)) and then enters the dialysis machine equipment; through the work of the dialysis machine equipment, waste is removed from the blood, and after circulating through the dialysis equipment, the blood then returns to the second access end 14 through the second needle 31, and then passes through the third The communication member 13 enters the venous blood vessel (the first blood vessel 20) as shown by arrow S31 in Fig. 16 . In this way, with the help of the second access end 14 and the first access end 10, it is convenient for the operator to insert acupuncture every time he performs treatment, and even non-professionals can perform the operation conveniently.

When hemodialysis is no longer to be performed, the needle used to perform hemodialysis is removed from the implantable access device. In the non-treatment stage, when the first needle 30 and the second needle 31 in Figure 16 are removed, the first communication member 11 is connected to the first access end 10 and the second access end 14, and can form blood from the second access end. The circulation path between the blood vessel 21 and the first blood vessel 20 via the implantable access device (shown by the dotted arrow S32 in Figure 16 ). This ensures that the implanted access device still has blood flow during the non-treatment period and prevents the formation of thrombus within the device.

In order to reduce other complications, such as venous proliferation, arterial blood steal, and improve fluid circulation efficiency during the treatment phase, in the embodiment shown in Figure 16, depending on the characteristic properties of the first to third communication members, the third The flow resistance of one communication member 11 is greater than the flow resistance of the second communication member 12, so that the flow of fluid from the second blood vessel 21 to the first blood vessel 20 through the implantable access device can be reduced without external control. flow. Furthermore, the flow resistance of the first communication member 11 may be greater than the flow resistance of the third communication member 13 , that is, the flow resistance of the second communication member 12 and the third communication member 13 is relatively small. For example, during the treatment phase, due to the large flow resistance of the first communication member 11, the fluid returned to the body through the second access end 14 is more likely to return to the first blood vessel 20 through the third communication member 13, thereby reducing the reflux phenomenon ( That is, the phenomenon that the fluid returning through the second access end 14 directly enters the first access end 10 through the first communication member 11 is reduced), and the fluid circulation efficiency is increased. In the non-treatment stage, due to the large flow resistance of the first communication member 11, the flow in the implantable access device is reduced, so that most of the blood flow can still flow into various parts of the body through the second blood vessel 21, thereby Reduce complications.

In one embodiment, the communication members for connecting blood vessels in any of the above embodiments can be connected to their corresponding blood vessels in an end-to-side anastomosis manner. Among them, in this application, the end-side anastomosis refers to connecting the side wall of a tube with a port. For example, a small window can be opened on the side of a blood vessel wall and one end of another tube can be connected. Combines with windows to connect, forming a "T" or "Y" fit. The end-to-side anastomosis needs to maintain an included angle of less than 90° and greater than 10°, and the opening direction of the included angle follows the flow direction of the blood to avoid greater impact of the blood flow on the end-to-side anastomosis.

Taking FIG. 16 as an example, a small window is opened on the side of the wall of the second blood vessel 21 and the first blood vessel 20, and one end of the second communication member 12 is connected to the small window on the side of the wall of the second blood vessel 21. It is kept connected by surgical suturing or by insertion, so that the blood in the second blood vessel 21 can flow into the second communication member 12 through the small window. One end of the third communication member 13 is connected to the small window on the side of the first blood vessel 20 wall, and the connection can be maintained by surgical suturing or by insertion. In this way, the third communication member 13 can be kept connected. Fluid can flow into the first blood vessel 20 through the small window.

In embodiments in which the communication member is connected to the blood vessels in an end-to-side anastomosis manner, the communication member may each include at least one conduit, and both ends of the conduit are respectively connected to the blood vessel and the access end to which the communication member is connected. Please refer to Figure 17, which is a schematic diagram of the third communication member including two conduits and connecting blood vessels in an embodiment of the present application. The implantable access device shown in Figures 11 to 15 is shown in Figure 16 The method of accessing a blood vessel is taken as an example for description, wherein the third communication member 13 includes a first conduit 130 and a second conduit 131 . One end of the first catheter 130 is connected to the first blood vessel 20 and the other end is connected to the second access end 140 . One end of the second conduit 131 is connected to the first blood vessel 20 and the other end is connected to the second access end 140 . It should be noted that in this example, the first blood vessel 20 is adapted to the number of conduits included in the third communication member 13 and is provided with two small windows on the side of the tube wall. Of course, the second communication member 12 of the implantable access device shown in Figures 11 to 15 can also be configured to include two conduits or More conduits, and the first communication member 11 and the second communication member 12 in Figures 9 and 10 are provided to include one, two, three, or more conduits.

Each of the above examples is only an illustration of the number of conduits included in the connecting member. In other embodiments, depending on the actual condition and needs, the above-mentioned connecting member may include any number of conduits, and the number of conduits included in different connecting members may be the same. However, this application is not limited here.

In one embodiment, in any of the above embodiments, one communication member for connecting the blood vessels is connected to the corresponding blood vessel in an end-to-side anastomosis manner, and the other communication member for connecting the blood vessels is connected to the corresponding blood vessel in an end-to-end anastomosis manner. of blood vessels. Among them, in this application, the end-to-end anastomosis refers to connecting one port of the tubular object with another port directly. For example, the blood vessel can be partially resected to form two broken ends after the blood vessel is separated. One end of the other tube is combined with one of the broken ends, and the other end is combined with the other broken end for connection.

Please refer to Figure 18, which is a schematic diagram of the connecting components of the implantable access device connected to blood vessels through end-to-side anastomosis and end-to-end anastomosis in one embodiment of the present application. In the figure, the implant shown in Figures 11 to 15 is used. For illustration, the access device connects the second blood vessel 21 and the first blood vessel 20 as an example. A small window is opened on the side of the wall of the first blood vessel 20, and one end of the third communication member 13 is connected to the side of the wall of the first blood vessel 20. The small window connection can be maintained through surgical suturing or insertion, so that the blood in the first blood vessel 20 can flow into the third communication member 13 through the small window. The second blood vessel 21 is separated to form two broken ends (210, 211). In order to adapt to the two broken ends (210, 211), the structure is as shown in the implantable access device shown in Figures 11 to 15. , the second connecting member 12 that needs to be connected to the two broken ends (210, 211) also needs to be set to two, for example, a new connecting member is added by adding a flow port on the end body and adding a connecting mechanism, so, The two ends of the two second communication members 12 are respectively combined with the two broken ends (210, 211), whereby the first access end 10 is connected to the second blood vessel 21. It should be understood that FIG. 18 is only an example. The third communication member 13 in FIG. 18 may also be configured to connect the first blood vessel 20 in an end-to-end anastomosis manner, and the second communication member 12 may be connected in an end-to-side anastomosis manner. Second blood vessel 21. Of course, as described in the previous embodiment of connecting blood vessels by end-to-side anastomosis, in this embodiment, the communication member for end-to-side anastomosis may also include one or more conduits, which will not be described again.

In some embodiments of the present application, an implantable access device is also proposed, which includes a first communication section and a second communication section. The second communication segment allows needle access to withdraw or inject fluid during the treatment phase. The first communication section is connected to one end of the second communication section to form a fluid flow path; wherein, depending on the characteristic attributes of the first communication section and the second communication section, the flow resistance of the first communication section greater than the flow resistance of the second flow section.

In one embodiment, the first communication section and the second communication section are an integral structure and are configured as an artificial blood vessel. In other words, a first communicating section and a second communicating section are formed on the artificial blood vessel, and different sections of the artificial blood vessel are set to have different characteristics. attributes, so that it can be divided into a first connected section with large flow resistance and a second connected section with small flow resistance.

In one embodiment, the functions, structures, materials, shapes, etc. implemented by the first communication section and the second communication section can be respectively the same as those in any of the embodiments shown in FIGS. 1 to 4 and related descriptions. The above-mentioned second communication member 12 is similar to the first communication member 11, wherein the first communication section is equivalent to the first communication member, and the second communication section is equivalent to the second communication member 12 and the first connection member. The input end 10 constructs a fluid passage and its working principle during the treatment or non-treatment phase is the same as described above. Please refer to the above-mentioned descriptions of Figures 1 to 4 and their related descriptions, which will not be described again here.

The aforementioned implantable access device including a first communication section and a second communication section can be used to connect selected blood vessels for various medical scenarios. Taking the scenario of blood purification such as hemodialysis as an example, two of the implantable access devices can be provided to form a complete blood circulation path. In this embodiment, the manner in which each implantable access device connects to blood vessels and the flow path formed during the treatment or non-treatment phase are similar to the aforementioned Figures 9 and 10 and their related descriptions. Those skilled in the art will hereby The second communication section can be equated to the second communication component 12 and the first access end 10 in Figures 9 and 10, and the first communication section can be understood to be equivalent to the first communication component 11 in Figures 9 and 10. Please understand Refer to the foregoing description of FIGS. 9 and 10 , which will not be described again here.

Of course, the aforementioned implantable access device including the first communication section and the second communication section can also be provided to form a complete blood circulation path. In this embodiment, the way the implantable access device connects the blood vessels and the The flow path formed in the non-treatment stage is similar to the aforementioned Figure 9 and its related descriptions. Those skilled in the art can equate the second communication section to the second communication member 12 and the first access end 10 in Figure 9. The first communication section is understood to be equivalent to the first communication member 11 in FIG. 9 . In the non-treatment phase, the first communication section is equivalent to the first communication member 11 and the second access end 14 in the previous embodiments. The part of the first communication section that allows needle penetration serves as the second access end 14, so that in The treatment phase is such that the second communication segment allows needle access to withdraw fluid from the second blood vessel during the treatment phase, and the first communication segment allows needle access to inject fluid toward the first blood vessel during the treatment phase.

In one embodiment, the functions, structures, materials, shapes, etc. implemented by the first communication section and the second communication section can be respectively the same as those in any of the embodiments shown in FIGS. 1 to 4 and related descriptions. The second communication member 12 described above is similar to the first communication member 11, wherein the first communication section is equivalent to the first communication member, and the second communication section is equivalent to the second communication member 12. The difference is The only difference is that the second communication member 12 and the first communication member 11 are respectively connected with the first access end 10 so that the first access end 10 serves as an interface for needle insertion, and the first communication section and the second communication section can be directly The portion connected and allowing needle penetration can be used as an access port, which constructs a fluid passage and works on the same principle as the second communication member 12 and the first communication member 11 in the treatment or non-treatment stage. Please refer to the aforementioned description of Figures 1 to 1 Figure 4 and its related description will not be described again here.

In some embodiments, the implantable access device may further include a third communication section in addition to the first communication section and the second communication section. The third communication section is connected to the other end of the first communication section and allows entry of a needle to inject or withdraw fluid during the treatment phase.

In one embodiment, the first communication section, the second communication section, and the third communication section are an integral structure and are configured as an artificial blood vessel. In other words, a first connected section, a second connected section, and a third connected section are formed on the artificial blood vessel. Different sections of the artificial blood vessel are set with different characteristic attributes, so that they are divided into first connected sections with relatively large flow resistance and The second communication section and the third communication section have relatively small flow resistance.

The artificial blood vessel in any of the above embodiments may be, for example, an artificial blood vessel made of polymer material, or may be, for example, a biological artificial blood vessel. The polymer materials include polyethylene (PE), polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester (also known as polyester fiber, PET), polyether urethane ( PEU), and polyurethane (PU), etc. The biological artificial blood vessels can also be called bioengineered tissue conduits, which refer to blood vessels prepared using extracellular matrix, such as acellular artificial blood vessels (Human Acellular Vessels, HAV) or skeleton acellular artificial blood vessels (Skeletal Acellular Vessels). , SAV).

In one embodiment, the functions, structures, materials, shapes, etc. implemented by the first communication section, the second communication section, and the third communication section can be respectively the same as those in the aforementioned Figures 11 to 18 and their related descriptions. The first communication member 11, the second communication member 12, and the third communication member 13 described in any embodiment are similar, wherein the first communication section is equal to the first communication member 11, and the second communication member The segment is equivalent to the second communication member 12 and the first access end, and the third communication segment is equivalent to the third communication member 13 and the second access end 14 . That is to say, the part of the second connected section that allows needles to penetrate is the first access end, and the part of the third connected section that allows needles to penetrate is the second access end. In this embodiment, the manner of accessing the blood vessel, the constructed fluid passage, and the working principle during the treatment or non-treatment stage can be referred to the above-mentioned descriptions of FIGS. 11 to 18 and related descriptions, and will not be described again here.

In some embodiments of the present application, a fluid circulation system is also proposed, which fluid circulation system can be applied to blood purification, such as hemodialysis. In one embodiment, the fluid circulation system is, for example, a hemodialysis system. Please refer to FIG. 19 , which is a schematic structural diagram of a fluid circulation system in an embodiment of the present application. The fluid circulation system includes at least one implantable access device 40 , an external pipeline device 41 , and a purification device 42 .

The implantable access device 40 can be implanted into the subcutaneous tissue of the body, such as the subcutaneous tissue of the arm area, the subcutaneous area of the chest area, etc. It can also be implanted into the human body via the skin. The external pipeline device 41 includes a lead-out pipeline 410, a return pipeline 411, a first needle 412, and a second needle 413. The lead-out pipeline 410 penetrates into the access end 400 through the first needle 412 to communicate with the implant. As for the access end 400 of the access device 40, the return pipeline 411 is inserted into the access end 401 through the second needle 413 to connect the access end 401. Place The purification device 42 is connected to the lead-out pipeline 410 and the return pipeline 411, and is used to purify the fluid output from the lead-out pipeline 410 and output it to the return pipeline 411.

Wherein, the implantable access device 40 can be configured as an implantable access device with a single access end, that is, the access end 400 and the access end 401 belong to different implantable access devices, For example, for the implantable access device described in any embodiment of FIGS. 1 to 10 , please refer to the aforementioned embodiments of FIGS. 1 to 10 and related descriptions, which will not be described again here. The implantable access device can also be configured as an implantable access device with two access ends, that is, the access end 400 and the access end 401 belong to one implantable access device, where the access end 400 is used to extract fluid, and the access end 401 is used to inject fluid, such as the implantable access device in any embodiment of FIG. 11 to FIG. 18 , please refer to the aforementioned any embodiment of FIG. 11 to FIG. 18 and its related descriptions. , which will not be described in detail here.

It should be understood that the implantable access device may also be configured as the aforementioned implantable access device including a first communication section and a second communication section, and may further include a third communication section, as described here. The part of one connected section that allows needle insertion is used as an access end to connect to the lead-out pipeline, and the part of the other connected section that allows needle insertion is used as another access end to connect to the return pipeline. This application is for implantable access. There is no restriction on the way in which the device access terminal is embodied.

Wherein, the first needle 412 or the second needle 413 may also be called a dialysis needle. In embodiments, the first needle 412 or the second needle 413 may be a puncture needle, a straight needle, a curved needle, a butterfly needle, or the like. Preferably, the first needle 412 or the second needle 413 can be a curved needle, which can prevent the needle from being accidentally dragged and separated from the access end during use. For example, the needle of the first needle 412 or the second needle 413 can be a 16-gauge needle or a 17-gauge needle with an inner hole diameter of 1.19 mm, which can also adapt to the required blood flow speed. For example, the needle is a 16-gauge needle with an inner diameter of 1.19 mm. is 1.19mm, which is suitable for allowing higher blood flow rates, such as 300cc/min. But it is not limited to this. In practical applications, different types of needles can be selected according to the patient's condition.

Among them, the extraction pipeline 410 is connected to the access end 400 to extract fluid from the body, and the return pipeline 411 is connected to the access end 401 to output the purified fluid to the body. In an embodiment, the lead-out pipeline 410 is, for example, an arterial pipeline, and the return pipeline 411 is, for example, a venous pipeline. The purification device 42 is, for example, a dialyzer. The dialyzer is also connected with a dialysis pipeline for introducing dialysate into the dialyzer. The dialyzer is used for purifying the blood flowing in the blood circuit and through a built-in The purification membrane used for blood purification forms a blood flow path for the patient's blood flow and a dialysate flow path for the dialysate flow; in embodiments, the dialyzer includes a dialysate chamber, a blood chamber and a semi-permeable membrane, etc., The membrane separates the dialysis chamber and the blood chamber, which in commonly used capillary type dialysers are formed by the entire internal volume of the hollow fibers, from each other, and the dialysate chamber by the surrounding hollow fibers of the casing of the dialyzer. The inner cavity is formed. In an embodiment, the top end of the dialyzer is connected to the arterial blood line, and the bottom end of the dialyzer is connected to the venous blood line. Types of dialyzers may include hemodialyzers, hemodiafilters, hemofilters, plasma separators, hemo-plasma This application can be used for devices of various specifications or uses, such as component separators, as long as they can separate toxins or molecular components in blood.

It should be understood that in an actual hemodialysis system, the arterial blood line is also provided with hydrophobic filters, dialysis pumps with built-in permeable membranes and hollow fiber membranes, valve devices, arterial pressure sensors, arterial pots and other components, so The arterial blood line is also equipped with a venous pot, a hydrophobic filter, a venous pressure sensor, a liquid level sensor, an air sensor, a valve device, etc.

In summary, the implantable access device and fluid circulation system proposed in this application can effectively reduce the aforementioned arterial blood theft and venous hyperplasia by arranging connecting components with different flow resistances on both sides of the access end. , thrombosis and other complications, and can reduce reflux and improve blood purification efficiency. Furthermore, the different flow resistances of the connecting components of this application are determined based on the characteristic attributes of the designed connecting components, and do not require additional operations on other objects. In this way, the structure is simple and easy to use, and can be suitable for hospital treatment and In various medical scenarios and treatment modes such as family therapy.

The above embodiments only illustrate the principles and effects of the present application, but are not used to limit the present application. Anyone familiar with this technology can modify or change the above embodiments without departing from the spirit and scope of the present application. Therefore, all equivalent modifications or changes made by those with ordinary knowledge in the technical field without departing from the spirit and technical ideas disclosed in this application shall still be covered by the claims of this application.

Claims

An implantable access device, characterized by including:

a first access end including a self-sealing member that allows entry of a needle to withdraw or inject fluid during a treatment phase;

A first communication member and a second communication member respectively communicate with the first access end and are used to provide a fluid flow path to or out of the first access end;

Wherein, depending on the characteristic properties of the first communication member and the second communication member, the flow resistance of the first communication member is greater than the flow resistance of the second communication member.
The implantable access device according to claim 1, characterized in that the implantable access device is used to connect a first blood vessel and a second blood vessel, and further includes a second access end and a third communication member. , the third communication member is used to connect the first blood vessel and the second access end, wherein:

The second communication member connects the second blood vessel so that the second blood vessel communicates with the first access end;

The second access end includes a self-sealing member, and needles inserted into the self-sealing members of the two access ends respectively enable an extracorporeal fluid circulation path to be formed during the treatment phase;

The first communication member is also connected to the second access end, so that a flow path of fluid from the second blood vessel to the first blood vessel is formed during the non-treatment phase, and the flow resistance of the first communication member is greater than The flow resistance of the second communication member is such that fluid flow from the second blood vessel through the device to the first blood vessel is reduced without external control.
The implantable access device according to claim 1, characterized in that the implantable access device is used to connect a first blood vessel and a second blood vessel, and further includes a second access end and a third communication member. , the third communication member is used to connect the second blood vessel, and the second access end, wherein:

The second communication member connects the first blood vessel so that the first blood vessel communicates with the first access end;

The second access end includes a self-sealing member, and needles inserted into the self-sealing members of the two access ends respectively enable an extracorporeal fluid circulation path to be formed during the treatment phase;

The first communication member is also connected to the second access end, so that a flow path of fluid from the second blood vessel to the first blood vessel is formed during the non-treatment phase, and the flow resistance of the first communication member is greater than The flow resistance of the second communication member is such that fluid flow from the second blood vessel through the device to the first blood vessel is reduced without external control.
The implantable access device according to claim 2 or 3, wherein the flow resistance of the first communication member is greater than the flow resistance of the third communication member.
The implantable access device according to claim 2 or 3, characterized in that the first communication member is configured as a through-hole structure or a tubular structure connecting the first access end and the second access end.
The implantable access device according to claim 1, wherein the implantable access device is used to connect a first blood vessel and a second blood vessel, wherein the first access end is used to extract fluid , the first communication member is used to connect the first blood vessel, and the second communication member is used to connect the second blood vessel, so that in a state without external control, the movement of the second blood vessel toward the first blood vessel through the device is reduced. fluid flow.
The implantable access device according to any one of claims 2 to 6, wherein the first blood vessel is a venous blood vessel, and the second blood vessel is an arterial blood vessel.
The implantable access device according to claim 1, wherein the implantable access device is used to connect a third blood vessel and a fourth blood vessel, wherein the first access end is used to inject fluid , the first communication member is used to connect the third blood vessel, and the second communication member is used to connect the fourth blood vessel, so that in a state without external control, the third blood vessel is reduced toward the fourth blood vessel through the device. fluid flow.
The implantable access device according to claim 8, wherein the third blood vessel is an arterial blood vessel, and the fourth blood vessel is a venous blood vessel.
The implantable access device according to claim 2, 3, 6, or 8, wherein each communication member is connected to its corresponding connected blood vessel in an end-to-side anastomosis manner.
The implantable access device according to claim 10, wherein each communication member includes at least one conduit, and two ends of each conduit are respectively connected to the blood vessel and access end to which the communication member is connected.
The implantable access device according to claim 2, 3, 6, or 8, characterized in that the communication member for connecting the blood vessels is connected to the corresponding blood vessel in an end-to-side anastomosis manner, and the other connecting member for connecting the blood vessel is A communication component is connected to the corresponding blood vessel in an end-to-end anastomosis manner.
The implantable access device according to any one of claims 1 to 12, wherein the manner in which the flow resistance of one communication member is greater than the flow resistance of another communication member includes any of the following: wherein the flow resistance of one communication member The cross-sectional area of the pipe is smaller than the cross-sectional area of the pipe of the other connecting member; or, one of the connecting members includes a flow resistance structure disposed in its pipe; or, the pipe of one of the connecting members is configured as an S-shaped or corrugated conduit.
The implantable access device according to claim 13, wherein the flow resistance structure is a one-way valve or a Tesla valve.
The implantable access device according to any one of claims 1 to 3, wherein each access end includes an end body, and the end body is provided with a first flow port, a second flow port, and an access port. ; The first flow port, the second flow port, and the access port are connected to each other through the inner cavity of the end body, the first flow port is also connected to the first communication member, and the second flow port is also connected to the second The communication components are connected, and the access port is used to set the self-sealing component.
The implantable access device according to claim 15, wherein the first flow port and the second flow port are arranged oppositely, and the inner cavity is configured to flow from the second flow port in the end body. A transition channel with increasing flow resistance and smooth surface is formed from the opening to the first flow opening.
The implantable access device according to claim 16, wherein the transition channel is configured as a channel with a conical inner wall.
The implantable access device according to claim 15, wherein the first access terminal further includes:

a first connection mechanism that connects the first flow port and the first communication member so that the first communication member communicates with the first flow port;

A second connection mechanism connects the second flow port and the second communication member so that the second communication member communicates with the second flow port.
The implantable access device according to claim 18, characterized in that each connection mechanism has a connection channel, and the connection channel and its corresponding flow port are smoothly transitionally connected.
The implantable access device according to claim 18, wherein the first connection mechanism includes:

A first connecting piece is formed on the end body extending outward corresponding to the first flow port for sleeved with the first communication member;

The first fixing part cooperates with the first connecting part to fix the first communication member on the first connecting part.
The implantable access device according to claim 20, wherein the end body and the first connecting member are configured as an integrally formed structure.
The implantable access device according to claim 20, wherein the first fixing member and the first connecting member cooperate with each other by at least one of clamping, snapping, and threading.
The implantable access device according to claim 20, wherein the first connecting member includes:

The screwing part has an external thread provided on its outer peripheral surface for screwing the first fixing member;

The connecting part is formed by continuing to extend along the screwing part, and is used to cover the first communication member, so that after the first fixing part is screwed, the first communication member is clamped in the connecting part.
The implantable access device according to claim 23, wherein a protruding structure is provided on the outer peripheral surface of the connecting portion to prevent the first communication member from falling off.
The implantable access device according to claim 23, wherein the first fixing member includes a resisting portion, and when the first fixing member is engaged with the first connecting member, the first fixing member The abutment portion presses against the first connecting piece and is sleeved on The first communication member is on the end surface of the first connecting piece, so that the internal channel of the first connecting member is flush with the connecting channel of the first connecting piece.
The implantable access device according to claim 15, characterized in that the access port is configured as a hole structure formed through the upper wall of the end body, and the self-sealing component is provided in an assembly or injection molding manner. within the pore structure.
The implantable access device according to claim 26, wherein the inner wall of the hole structure is conical.
The implantable access device according to claim 26, wherein a groove is provided on the upper wall of the end body around the hole structure, and the self-sealing member has a groove adapted to the groove. Protrusions are provided to prevent the self-sealing member from detaching from the hole structure.
The implantable access device according to claim 15, wherein the upper surface of the end body is square, and the access port is an inscribed circle of the square on the upper surface.
The implantable access device according to claim 15, wherein the left and right side walls of the end body conforming to the direction from the first flow port to the second flow port are configured to have arcuate surfaces corresponding to the shape of the inner cavity.
The implantable access device according to claim 15, wherein the end body is configured to be made of metal material and/or polymer material.
The implantable access device according to claim 31, wherein the metal material includes stainless steel, copper, aluminum, titanium, and composites thereof, and the polymer material includes polycarbonate, polypropylene, poly Ethylene, and PTFE.
The implantable access device according to any one of claims 1 to 3, wherein each communication member is configured as an artificial blood vessel.
The implantable access device according to claim 33, wherein the artificial blood vessels include artificial blood vessels made of PTFE material, ePTFE material, PEU material, PET material or PU material, and biological artificial blood vessels.
The implantable access device according to claim 34, wherein the second communication member and the third communication member are made of materials that can be used as artificial blood vessels, and the first communication member includes PTFE material.
The implantable access device according to claim 2 or 3, characterized in that the first communication member is configured as a U-shaped communication conduit.
The implantable access device according to claims 1 to 3, characterized in that each access end is provided with a needle entry mark, and the needle entry mark is used to prompt the fluid flow direction of the access end or to distinguish the access end. It is the venous access end or the arterial access end.
The implantable access device according to claim 37, wherein the needle entry mark is represented by the size, shape, position, or softness and hardness of the access end.
The implantable access device according to claim 37, wherein the needle entry mark is configured as a concave-convex structure on the side close to the skin of the human body after the access end is implanted in the human body.
The implantable access device of claim 1, wherein the self-sealing member is configured to allow penetration of a needle to communicate with the access end and withdrawal of the needle to reseal the hole formed by insertion of the needle, and thereby prevent fluid release.
The implantable access device according to claim 40, wherein the self-sealing member can be made of silicone material, rubber material, latex material, or polymer material.
The implantable access device according to any one of claims 1 to 3, characterized in that each access end is provided with a positioning structure, and the positioning structure is used to locate the position of the access end in the body.
The implantable access device according to any one of claims 1 to 3, characterized in that the implantable access device is used for blood purification.
The implantable access device according to any one of claims 1 to 3, characterized in that, the inner wall of the cavity of the first access end and/or the second access end is provided with rigidity to prevent needle penetration. structure.
The implantable access device according to any one of claims 1 to 3, wherein the needle is a puncture needle, a straight needle, a curved needle, or a butterfly needle.
The implantable access device according to claim 1, wherein an anticoagulant coating is provided in the first access end.
The implantable access device according to any one of claims 1 to 3, characterized in that a sealing coating is provided at the connection between each communication member and each access end.
The implantable access device according to any one of claims 1 to 3, characterized in that the pipe inner diameter ratio of the first communication member and the second communication member or the third communication member can be set to 1 Any ratio between /2 and 1/8.
The implantable access device according to any one of claims 1 to 3, wherein the inner diameter of the second communication member or the third communication member is set to any value from 6 mm to 8 mm, and the first communication member is The inner diameter of the pipe of the connecting member is set to any value from 1mm to 3mm.
The implantable access device according to any one of claims 1 to 3, wherein when the implantable access device connects the first blood vessel and the second blood vessel, at least part of the communication member allows bending or stretching. To meet the distance requirements between the first blood vessel and the second blood vessel.
An implantable access device, characterized by including:

a second communication section that allows the needle to enter to extract or inject fluid during the treatment phase; the part of the second communication section that allows the needle to enter is the first access end;

A first communication section is connected to one end of the second communication section to form a fluid flow path; wherein, depending on the characteristic attributes of the first communication section and the second communication section, the flow resistance of the first communication section greater than the flow resistance of the second flow section.
The implantable access device according to claim 51, characterized in that the implantable access device is used to connect the first blood vessel and the second blood vessel, and further includes a third communication section, wherein:

the second communication segment connects to the second blood vessel to allow needle access to withdraw fluid from the second blood vessel during a treatment phase;

The third communication section is connected to the other end of the first communication section and is also used to connect the first blood vessel, which allows the needle to enter and inject fluid into the first blood vessel during the treatment phase; the third communication section allows the needle to enter Part is the second access terminal;

The third communication section also forms a fluid flow path together with the first communication section and the second communication section during the non-treatment phase, reducing the flow of fluid from the second blood vessel to the third via the device without external control. Fluid flow in a blood vessel.
The implantable access device according to claim 51, characterized in that the implantable access device is used to connect the first blood vessel and the second blood vessel, and further includes a third communication section, wherein:

the second communication segment connects to the first blood vessel to allow needle access to withdraw fluid from the first blood vessel during a treatment phase;

The third communication section is connected to the other end of the first communication section and is also used to connect the second blood vessel, which allows the needle to enter and inject fluid into the second blood vessel during the treatment phase; the third communication section allows the needle to enter Part is the second access terminal;

The third communication section also forms a fluid flow path together with the first communication section and the second communication section during the non-treatment phase, reducing the flow of fluid from the second blood vessel to the third via the device without external control. Fluid flow in a blood vessel.
The implantable access device according to claim 52 or 53, wherein the flow resistance of the first communication section is greater than the flow resistance of the third flow section.
The implantable access device according to claim 51, characterized in that the implantable access device is used to connect a first blood vessel and a second blood vessel; wherein the second communication section is connected to the second blood vessel. A blood vessel that allows a needle to enter to draw fluid from the second blood vessel during the treatment phase; the first communication section connects the first blood vessel and reduces fluid from the second blood vessel during the non-treatment phase without external control. Fluid flow through the device toward the first vessel.
The implantable access device according to any one of claims 52 to 55, wherein the first blood vessel is a venous blood vessel, and the second blood vessel is an arterial blood vessel.
The implantable access device of claim 55, wherein the first communication segment further allows needle access to inject fluid toward the first blood vessel during a treatment phase, the first communication segment allows needle access The part is the second access terminal.
The implantable access device according to claim 51, characterized in that the implantable access device is used to connect a third blood vessel and a fourth blood vessel, wherein the second communication section is used to connect the The fourth blood vessel is used to allow the needle to enter and inject fluid toward the first blood vessel during the treatment phase. The first communication section is used to connect the third blood vessel to reduce the flow of fluid from the second blood vessel to the first blood vessel through the device without external control. Fluid flow in blood vessels.
The implantable access device according to claim 58, wherein the third blood vessel is an arterial blood vessel, and the fourth blood vessel is a venous blood vessel.
The implantable access device according to any one of claims 51 to 53, wherein each communication section is an integral structure and is configured as an artificial blood vessel.
The implantable access device according to claim 60, wherein the artificial blood vessels include artificial blood vessels made of PTFE material, ePTFE material, PEU material, PET material or PU material, and biological artificial blood vessels.
A fluid circulation system, characterized by including:

An implantable access device as claimed in any one of claims 1 to 61;

The external pipeline device includes a lead-out pipeline and a return pipeline. The lead-out pipeline is used to connect one access end of the implantable access device, and the return pipeline is used to connect the other access end. ;

A purification device is connected to the lead-out pipeline and the return pipeline, and is used to purify the fluid output from the lead-out pipeline and output it to the return pipeline.