X-type hemodialysis port

Abstract

The application discloses an X-shaped hemodialysis port, which comprises a main body and a puncture cover detachably mounted on the main body, wherein the main body comprises a base and four connecting portions distributed in an X shape on the periphery of the base, and the puncture cover is suitable for separating the base into an arterial chamber and a venous chamber which are in communication with each other, the arterial chamber is communicated with two connecting portions, and the venous chamber is communicated with the other two connecting portions. By implanting the X-shaped hemodialysis port subcutaneously, the traditional arteriovenous fistula is replaced, and when hemodialysis is performed, two puncture needles only need to puncture the skin of a patient and the puncture cover, so that the hemodialysis can be performed, the pain and the secondary injury caused by repeated puncture of blood vessels of the patient are reduced, and in addition, the main body and the puncture cover are detachably connected, the puncture cover is convenient to replace, and the use cost of the patient is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an X-type hemodialysis port. Background Technology

[0002] Hemodialysis (HD), commonly known as kidney dialysis, is a renal replacement therapy for patients with acute and chronic renal failure. It involves draining blood from the patient's body and passing it through a dialyzer composed of numerous hollow fibers. The blood exchanges substances with an electrolyte solution (dialysis fluid) containing a concentration similar to that in the body through diffusion, ultrafiltration, adsorption, and convection within and outside the hollow fibers. This process removes metabolic waste products, maintains electrolyte and acid-base balance, and removes excess water. The purified blood is then returned to the patient, thus replacing the kidneys in metabolizing toxins and sustaining life.

[0003] During dialysis, needles are typically inserted into the artery and vein of the forearm. Blood is drawn from the artery, purified in the hemodialysis machine, and then returned to the vein. Hemodialysis requires rapidly drawing blood into the machine, with a flow rate exceeding 200 ml per minute. To achieve this, doctors developed an arteriovenous fistula technique. This involves ligating and anastomosing the distal radial artery and superficial cephalic vein of the upper limb proximal to the heart (there are three types of arteriovenous fistulas in the forearm: end-to-end, end-to-side, and side-to-side), thus creating an arteriovenous fistula. Using arterial pressure, the vein becomes arterialized over time, increasing blood flow velocity, making it easier to puncture during hemodialysis and ensuring sufficient blood supply for the treatment.

[0004] Hemodialysis is one of the main treatments for chronic renal failure. Generally, outpatients undergoing regular hemodialysis routinely need to have 5 hemodialysis sessions every 2 weeks. Each dialysis session involves two arteriovenous fistula punctures, resulting in a total of 132 dialysis sessions and 264 punctures per year. If the blood vessels are directly punctured to connect to the blood vessels during each hemodialysis session, it not only increases the patient's pain, but also frequently puncturing blood vessels can easily lead to vascular lesions, such as vascular calcification, arteriovenous thrombosis, and the formation of hemangiomas. Summary of the Invention

[0005] The purpose of this invention is to address the shortcomings of existing technologies by proposing an X-type hemodialysis port, which utilizes the re-puncture capability of the dialysis port to replace arteriovenous fistulas, thereby reducing the pain and side effects caused by repeated punctures for hemodialysis patients.

[0006] The technical solution to achieve the objective of this invention is:

[0007] An X-shaped hemodialysis port includes a main body and a puncture cap detachably mounted on the main body. The main body includes a base and four connecting parts distributed in an X-shape around the outer periphery of the base. The puncture cap is adapted to divide the base into interconnected arterial chambers and venous chambers. The arterial chambers are connected to two of the connecting parts, and the venous chambers are connected to the other two connecting parts.

[0008] Furthermore, the base is made of nickel-titanium alloy. This ensures a certain degree of hardness, making it less susceptible to flattening or puncture damage, while also guaranteeing biocompatibility and anticoagulation requirements during implantation.

[0009] Furthermore, the puncture cover includes a central septum located in the middle and puncture membranes respectively disposed on both sides of the central septum. The outer periphery of the puncture membrane is provided with an installation part that can be detachably connected to the base. The central septum is provided with a first through hole. The central septum divides the base into two cavities. The two cavities and the puncture membranes on both sides respectively form an arterial chamber and a venous chamber. The arterial chamber and the venous chamber are connected through the first through hole.

[0010] Furthermore, there are two central diaphragms, and the puncture cap is fixedly provided with a control structure located between the two central diaphragms and adapted to open and close the first through hole.

[0011] Furthermore, the first through holes of the two central septa are interconnected, and the control structure includes an annular filling cavity surrounding the outer periphery of the first through hole that is integrally connected, a first catheter communicating with the annular filling cavity, and a control balloon located at the other end of the first catheter. The tension of the control balloon is less than the tension of the annular filling cavity and is filled with physiological saline.

[0012] Furthermore, the control structure includes a partition plate and a pressing mechanism disposed between the two central diaphragms. The partition plate is provided with a second through hole, which is adapted to achieve complete overlap and complete misalignment with the first through hole through the pressing mechanism.

[0013] Furthermore, the pressing mechanism includes a U-shaped frame fixedly installed between two central diaphragms. The diaphragm is movably installed within the frame, and a spring is provided between the bottom of the diaphragm and the frame. The diaphragm has a heart-shaped groove, and a connecting rod is rotatably mounted on the frame. The other end of the connecting rod has a protrusion that engages with the bottom of the heart-shaped groove and is adapted to move along the heart-shaped groove. By pressing the diaphragm downward, the protrusion moves upward from the bottom of the heart-shaped groove along the groove and engages with the recess in the upper part of the groove. At this time, the second through hole and the first through hole are completely aligned, thus opening the fistula. By pressing the diaphragm downward again, the protrusion continues to move from the recess along the groove and returns to the lowest point of the groove. At this time, the second through hole and the first through hole are completely misaligned again, thus closing the fistula.

[0014] Furthermore, the central diaphragm is made of a nickel-titanium alloy.

[0015] Furthermore, the puncture membrane is made of medical-grade silicone.

[0016] Furthermore, the mounting part is made of nickel-titanium alloy and is connected to the base by screws.

[0017] Furthermore, the puncture cap has two hollow cavities located in the arterial chamber and the venous chamber respectively below it, and the bottom of the hollow cavities has a second catheter that passes through the connecting part and is adapted to extend into the blood vessel.

[0018] Furthermore, the hollow cyst is made of nickel-titanium alloy, which ensures the requirements for hardness, biocompatibility, and anticoagulation.

[0019] Furthermore, the second catheter includes an inner layer, a middle layer, and an outer layer arranged sequentially from the inside out. The inner layer is a PTFE inner tube, which meets the requirements for anticoagulation and avoids the risk of thrombosis with long-term use. The middle layer is a stainless steel flat wire braided layer to ensure the rigidity of the second catheter. The outer layer is made of high-density polyethylene to ensure that the surface of the second catheter is soft and avoids damage to blood vessels.

[0020] Furthermore, the connecting part includes a PTFE artificial blood vessel and a bulboscopic covered stent disposed on the inner wall of the PTFE artificial blood vessel. The PTFE artificial blood vessel has a double-layer structure, wherein the outer layer is shorter than the inner layer and is adapted to anastomose with the blood vessel, and the inner layer is connected to the bulboscopic covered stent.

[0021] By adopting the above technical solution, the present invention has the following beneficial effects:

[0022] (1) This invention sets up four connecting parts to anastomose with the four ports of the severed artery and vein respectively. The puncture cap divides the base into interconnected arterial chambers and venous chambers. The two connecting parts connected to the artery connect to the arterial chamber, and the connecting parts connected to the vein connect to the venous chamber, thereby forming an X-type hemodialysis port equivalent to an arteriovenous fistula. By implanting this invention under the skin to replace the traditional arteriovenous fistula, during hemodialysis, the two puncture needles only need to puncture the patient's epidermis and the puncture cap to perform hemodialysis, reducing the pain and side effects caused by repeated puncture of blood vessels. In addition, the main body and the puncture cap are detachably connected, which facilitates the replacement of the puncture cap and reduces the cost of use for patients.

[0023] (2) The puncture cap of the present invention divides the base into an arterial chamber and a venous chamber by setting a central diaphragm, and opens a first through hole as a fistula to realize the connection between the arterial chamber and the venous chamber. The puncture membrane enables repeated puncture of the needle tube. The mounting part facilitates connection with the main body.

[0024] (3) The present invention has two central diaphragms. The opening and closing of the fistula can be achieved by setting a regulating structure between the two central diaphragms. When hemodialysis is performed, the fistula is opened to ensure sufficient blood flow rate. After hemodialysis is completed, the fistula is closed to avoid repeated impact of arterial blood on the vein, which could lead to the formation of venous aneurysm. At the same time, it is also to prevent arterial blood from flowing into the vein through the fistula for a long time, which would increase the burden on the patient's heart and lead to heart failure.

[0025] (4) The control structure of the present invention includes an annular filling cavity surrounding the interconnected first through-hole. The annular filling cavity is connected to a control balloon with a tension less than that of the annular filling cavity via a first catheter. When the dialysis port of the present invention is implanted, the control balloon is pre-embedded subcutaneously on the back of the wrist. Normally, the control balloon is flattened by wearing a wristband, thereby forcing saline into the annular filling cavity around the fistula. The fistula is closed by squeezing the fistula through the annular filling cavity. During dialysis, the wristband is removed, and the tension difference between the annular filling cavity and the control balloon itself is used to force saline into the control balloon subcutaneously on the back of the wrist, thereby opening the fistula.

[0026] (5) Another control structure of the present invention includes a partition and a pressing mechanism disposed between two central diaphragms. The partition has a second through hole of the same size as the first through hole. The pressing mechanism drives the partition to move up and down, so as to achieve complete overlap and complete misalignment between the second through hole and the first through hole, thereby realizing the opening and closing of the fistula.

[0027] (6) The central diaphragm of the present invention is made of nickel-titanium alloy, which ensures hardness while meeting the requirements of biocompatibility and anticoagulation.

[0028] (7) The puncture membrane of the present invention is made of medical silicone, which meets the requirement that it can automatically close after repeated needle punctures.

[0029] (8) The mounting part of the present invention is made of nickel-titanium alloy, which ensures hardness while meeting the requirements of biocompatibility and anticoagulation. The mounting part is connected to the base by screws, realizing the detachable connection between the puncture cap and the main body. The connection is firm and the installation and disassembly are convenient.

[0030] (9) The arterial and venous chambers of this invention are provided with a hollow sac located below the puncture cap. A second catheter extending to the blood vessel is provided at the bottom of the hollow sac. By setting the second catheter, during hemodialysis, the outflowing and inflowing blood is kept away from the fistula, ensuring that the blood before and after dialysis does not mix, thereby improving the dialysis effect for the patient. By setting the hollow sac, the safety and accuracy of the puncture needle insertion into the puncture membrane are ensured, so as not to damage the second catheter, while ensuring blood drainage.

[0031] (10) The connection part of the present invention has a double-layer structure, including a PTFE artificial blood vessel and a bulb expansion covered stent. The PTFE artificial blood vessel has a double-layer structure, wherein the outer layer is shorter than the inner layer and is used to anastomose with the severed forearm artery / vein, and the inner layer is connected to the bulb expansion covered stent. By setting the bulb expansion covered stent, it is used to support the blood vessels near the anastomosis and cover the blood vessel anastomosis, thereby reducing the occurrence of anastomotic stenosis. Attached Figure Description

[0032] To make the content of this invention easier to understand, the invention will be further described in detail below with reference to specific embodiments and accompanying drawings, wherein:

[0033] Figure 1 This is a schematic diagram of the implantation location of the present invention;

[0034] Figure 2 This is a schematic diagram of the structure of the present invention;

[0035] Figure 3 This is a schematic diagram of the internal structure of the present invention;

[0036] Figure 4 This is a schematic diagram of the control structure in Example 1;

[0037] Figure 5 This is a schematic diagram of the control structure in the open state of Example 2;

[0038] Figure 6 This is a schematic diagram of the control structure in the off state in Example 2.

[0039] The labels in the attached diagram are:

[0040] 1. Base, 2. Connecting part, 2-1. PTFE artificial blood vessel, 2-2. Balloon-expandable covered stent, 3. Central septum, 3-1. First through hole, 4. Puncture membrane, 5. Mounting part, 6. Hollow balloon cavity, 7. Second catheter, 8. Adjustment structure, 8-1. Annular filling cavity, 8-2. First catheter, 8-3. Control balloon, 8-4. Second through hole, 8-4-1. Heart-shaped groove, 8-4-2. Frame, 8-5. Spring, 8-6. Connecting rod, 8-7. Protrusion, 8-7-1. Detailed Implementation

[0041] To better understand the above technical solutions, the following will provide a detailed explanation of the technical solutions in conjunction with the accompanying drawings and specific implementation methods.

[0042] (Example 1)

[0043] like Figures 1 to 4The X-type hemodialysis port shown includes a main body and a detachable puncture cap mounted on the main body. The main body includes a base 1 and four connecting parts 2 arranged in an X-shape around the outer periphery of the base 1. The four connecting parts 2 are respectively anastomosed to the four ports of a severed artery and vein. The puncture cap divides the base 1 into two interconnected arterial chambers and venous chambers. The arterial chamber is connected to two of the connecting parts 2, and the venous chamber is connected to the other two connecting parts 2, thereby forming an X-type hemodialysis port equivalent to an arteriovenous fistula. By implanting the X-type hemodialysis port of this embodiment subcutaneously, replacing the traditional arteriovenous fistula, during hemodialysis, the two puncture needles only need to puncture the patient's epidermis and the puncture cap to perform hemodialysis, reducing the pain and collateral damage caused by repeated vascular punctures. In addition, the detachable connection between the main body and the puncture cap facilitates the replacement of the puncture cap, reducing the patient's usage costs.

[0044] Specifically, the puncture cap includes a central septum 3, puncture membranes 4, and a mounting part 5. The mounting part 5 has a ring-shaped structure, with the central septum 3 located in the middle, dividing the base 1 into two cavities. Two puncture membranes 4 are symmetrically located on the left and right sides of the central septum 3. The side of the puncture membrane 4 closest to the mounting part 5 is connected to the inner ring of the mounting part 5. The two cavities, together with the two puncture membranes 4 on either side, form an arterial chamber and a venous chamber, respectively. The puncture membranes 4 replace blood vessels to allow for repeated needle punctures. The mounting part 5 facilitates connection to the main body. The puncture membranes 4 are made of medical-grade silicone, meeting the requirement of automatic closure after repeated needle punctures. The mounting part 5 has four mounting holes, and the base 1 has corresponding screw holes. Screws are installed in the mounting holes, allowing for a detachable and secure connection between the puncture cap and the main body. The connection is firm, and installation and disassembly are convenient.

[0045] Two central septa 3 are provided, and each central septa 3 has a first through hole 3-1. The two first through holes 3-1 are connected to each other to form the fistula of the X-type hemodialysis port in this embodiment. The arterial chamber and the venous chamber are connected through the fistula. Below the puncture cap, there are two independent hollow cavities 6 located in the arterial chamber and the venous chamber, respectively. The bottom of the hollow cavities 6 is provided with a second catheter 7 that passes through the connecting part 2 and is adapted to extend to the blood vessel. By setting the second catheter 7, during hemodialysis, the outflow and inflow of blood are kept away from the fistula, ensuring that the blood before and after dialysis does not mix, thereby improving the dialysis effect for the patient. By setting the hollow cavities 6, the safety and accuracy of the puncture needle insertion into the puncture membrane 4 are ensured, so as not to damage the second catheter 7, while ensuring blood drainage. The second catheter 7 includes an inner layer, a middle layer and an outer layer arranged sequentially from the inside to the outside. The inner layer is made of PTFE, which meets the requirements for anticoagulation and avoids the risk of thrombosis with long-term use; the middle layer is a stainless steel flat wire braided layer to ensure that the second catheter 7 has moderate rigidity; the outer layer is made of high-density polyethylene to ensure that the surface of the second catheter 7 is soft and avoids damage to blood vessels.

[0046] Because a frequently open arteriovenous fistula can easily lead to the formation of venous aneurysms, and the long-term flow of arterial blood into the vein through the fistula can also increase the burden on the patient's heart, potentially leading to heart failure. Therefore, this embodiment includes a regulating structure 8 between the two central septa 3, used to open and close the first through-hole 3-1. During hemodialysis, the fistula is opened to ensure sufficient blood flow; after hemodialysis, the fistula is closed to prevent repeated impact of arterial blood on the vein.

[0047] Specifically, the control structure 8 in this embodiment includes an annular filling cavity 8-1 surrounding the outer periphery of the first through hole 3-1, a first catheter 8-2 communicating with the annular filling cavity 8-1, and a control balloon 8-3 located at the other end of the first catheter 8-2. The annular filling cavity 8-1 is composed of multiple interconnected small balloons connected in series. The tension of the control balloon 8-3 is less than that of the annular filling cavity 8-1, and it is filled with saline solution. When implanting an X-type hemodialysis port, the control balloon 8-3 is pre-embedded subcutaneously on the back of the wrist. Normally, the control balloon 8-3 is flattened by wearing a wristband, thereby forcing saline solution into the annular filling cavity 8-1 around the fistula. The fistula is closed by the pressure of the annular filling cavity 8-1 on the fistula. During dialysis, the wristband is removed, and the tension difference between the annular filling cavity 8-1 and the control balloon 8-3 is used to force saline solution into the control balloon 8-3 subcutaneously on the back of the wrist, thus opening the fistula.

[0048] In this embodiment, the connecting part 2 has a double-layer structure, including a PTFE artificial blood vessel 2-1 and a bulbar expansion covered stent 2-2 disposed on the inner wall of the PTFE artificial blood vessel 2-1. The PTFE artificial blood vessel 2-1 has a double-layer structure, with the outer layer being shorter than the inner layer. The outer PTFE artificial blood vessel 2-1 is used to anastomose with the severed forearm artery / vein, and the inner PTFE artificial blood vessel 2-1 is connected to the bulbar expansion covered stent 2-2. By setting the bulbar expansion covered stent 2-2, the blood vessel near the anastomosis is supported, and the anastomosis is covered, thereby reducing the occurrence of anastomotic stenosis.

[0049] The base 2, central septum 3, mounting part 5, and hollow sac 6 are all made of nickel-titanium alloy, which ensures that the three have a certain degree of hardness and are not easily crushed or punctured, while ensuring biocompatibility and anticoagulation requirements during implantation.

[0050] (Example 2)

[0051] like Figure 5 and Figure 6 As shown, the structure of this embodiment is similar to that of embodiment 1, except that the two first through holes 3-1 are not connected to each other and the control structure 8 is different.

[0052] Specifically, the control structure 8 includes a partition 8-4 disposed between two central diaphragms 3 and a pressing mechanism. The partition 8-4 has a second through hole 8-4-1 of the same size as the first through hole 3-1. The pressing mechanism includes a U-shaped frame 8-5 fixedly installed between the two central diaphragms 3. The partition 8-4 is movably installed in the frame 8-5. A spring 8-6 is provided between the bottom of the partition 8-4 and the frame 8-5. The partition 8-4 has a heart-shaped groove 8-4-2. A connecting rod 8-7 is rotatably installed at the bottom of the frame 8-5. The upper end of the connecting rod 8-7 has a protrusion 8-7-1 that engages with the bottom of the heart-shaped groove 8-4-2 and can move along the heart-shaped groove 8-4-2. By pressing down on the partition 8-4, the protrusion 8-7-1 moves upward from the bottom of the heart-shaped groove 8-4-2 along the heart-shaped groove 8-4-2 and engages with the recess at the top of the heart-shaped groove 8-4-2. At this time, the second through hole 8-4-1 completely overlaps with the first through hole 3-1. Figure 5 As shown, the fistula is opened; press down on the partition 8-4 again, and the protrusion 8-7-1 continues to move from the concave position along the heart-shaped groove 8-4-2 and returns to the lowest point of the heart-shaped groove 8-4-2. At this time, the second through hole 8-4-1 and the first through hole 3-1 are completely misaligned again, as shown. Figure 6 As shown, the fistula is closed. Compared to Example 1, no wristband is required, making it more convenient to use.

[0053] This invention features four connecting parts that anastomose with the four ports of a severed artery and vein. The puncture cap divides the base into interconnected arterial and venous chambers. The two connecting parts connected to the artery communicate with the arterial chamber, and the connecting part connected to the vein communicates with the venous chamber, thus forming an X-shaped hemodialysis port equivalent to an arteriovenous fistula. By implanting it subcutaneously, it replaces the traditional arteriovenous fistula. During hemodialysis, the two puncture needles only need to puncture the patient's skin and the puncture cap, reducing the pain and side effects of repeated vascular punctures. Furthermore, the main body and the puncture cap are detachable, facilitating cap replacement and reducing patient costs. A control mechanism allows the fistula to be opened or closed, preventing repeated arterial blood impact on the vein, which could lead to venous aneurysm formation. It also prevents long-term arterial blood from flowing into the vein through the fistula, thus avoiding increased cardiac burden and preventing heart failure, making it safer and more reliable.

[0054] The specific embodiments described above further illustrate the purpose, technical solution, and beneficial effects of the present invention. It should be understood that the above descriptions are merely specific embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. An X-type hemodialysis port, characterized in that: The device includes a main body and a puncture cap detachably mounted on the main body. The main body includes a base (1) and four connecting parts (2) arranged in an X-shape around the outer periphery of the base. The puncture cap is adapted to divide the base (1) into interconnected arterial chambers and venous chambers. The arterial chamber is connected to two of the connecting parts (2), and the venous chamber is connected to the other two connecting parts (2). The puncture cap includes a central septum (3) located in the middle and puncture membranes (4) respectively located on both sides of the central septum (3). The outer periphery of the puncture membranes (4) is provided with mounting parts (5) detachably connected to the base (1). The central septum (3) is provided with a first through hole. (3-1) The central diaphragm (3) divides the base (1) into two cavities. The two cavities form an arterial chamber and a venous chamber with the puncture membranes (4) on both sides, respectively. The arterial chamber and the venous chamber are connected through the first through hole (3-1). Two hollow sacs (6) are provided below the puncture cover, located in the arterial chamber and the venous chamber, respectively. The bottom of the hollow sac (6) is provided with a second catheter (7) that passes through the connecting part (2) and is adapted to extend to the blood vessel. There are two central diaphragms (3). The puncture cover is fixed with a control structure (8) located between the two central diaphragms (3) and adapted to open and close the first through hole (3-1).

2. The X-type hemodialysis port according to claim 1, characterized in that: The first through holes (3-1) of the two central septa (3) are connected to each other. The control structure (8) includes an annular filling cavity (8-1) surrounding the outer periphery of the first through hole (3-1) which is connected as a whole, a first catheter (8-2) communicating with the annular filling cavity (8-1), and a control balloon (8-3) at the other end of the first catheter (8-2). The tension of the control balloon (8-3) is less than the tension of the annular filling cavity (8-1) and is filled with physiological saline.

3. The X-type hemodialysis port according to claim 1, characterized in that: The control structure (8) includes a partition plate (8-4) between two central diaphragms (3) and a pressing mechanism. The partition plate (8-4) is provided with a second through hole (8-4-1). The second through hole (8-4-1) is adapted to achieve complete overlap and complete misalignment with the first through hole (3-1) through the pressing mechanism.

4. The X-type hemodialysis port according to claim 1, characterized in that: The central diaphragm (3) is made of nickel-titanium alloy.

5. The X-type hemodialysis port according to claim 1, characterized in that: The puncture membrane (4) is made of medical silicone.

6. The X-type hemodialysis port according to claim 1, characterized in that: The mounting part (5) is made of nickel-titanium alloy and is connected to the base (1) by screws.

7. The X-type hemodialysis port according to claim 1, characterized in that: The connecting part (2) includes a PTFE artificial blood vessel (2-1) and a bulb expansion covered stent (2-2) disposed on the inner wall of the PTFE artificial blood vessel (2-1). The PTFE artificial blood vessel (2-1) has a double-layer structure, wherein the outer layer is shorter than the inner layer and is adapted to be anastomosed with the blood vessel, and the inner layer is connected to the bulb expansion covered stent (2-2).

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