Temperature-controllable magnetic separation blood transfusion pipeline

Abstract

The invention discloses a temperature-controllable magnetic separation blood transfusion pipeline, and belongs to the technical field of blood separation pipelines. The blood transfusion pipeline comprises an inner-layer pipe and an outer-layer sleeve arranged on the periphery of the inner-layer pipe in a sleeving mode. A gap between the inner-layer tube and the outer-layer sleeve is arranged to be a first channel and is used for transporting a cooling medium, and the inner-layer tube is arranged to transport blood to be separated; one end of the inner-layer pipeline is provided with a non-return tip, one side of the non-return tip is provided with a non-return bead, and the non-return bead and the non-return tip are sequentially arranged in the blood transportation direction. The non-return ball and the non-return tip are matched with each other, so that only blood can pass through the non-return ball, and magnetized cells or non-magnetic particles with relatively large particle sizes are prevented from entering back-section blood circulation; the first channel directly cools the blood flowing through the inner-layer tube, the cooling efficiency is high, cooling is uniform, heat exposure of the blood is reduced to the maximum extent from the path, and the heat injury risk is reduced.

Description

Technical Field

[0001] This application belongs to the field of blood separation pipeline technology, and specifically relates to a temperature-controllable magnetic separation infusion pipeline. Background Technology

[0002] In the context of extracorporeal therapy for leukemia, extracorporeal circulation (CPB) is a key technology for maintaining patients' lives. Blood faces two main challenges when flowing through the tubing of these systems: first, the warming of the blood due to mechanical pumps, long pathways, and connectors can cause protein denaturation, hemolysis, and inflammatory reactions; second, traditional tubing is passively laid, making precise adjustment and fixation difficult in complex anatomical locations or minimally invasive surgeries.

[0003] Currently, solutions to the problem of blood warming mainly rely on system-wide heat exchangers or cooling of blood storage tanks, but there are limited active cooling methods for the tubing itself. Regarding tubing manipulation, it primarily depends on surgeons manually bending and fixing it, lacking the ability to make real-time, flexible adjustments during surgery.

[0004] Currently, there is no mature, integrated tubing system for blood transfusion, temperature maintenance, and active maintenance of magnetic spatial positioning guidance characteristics in the field of in vitro magnetized separation of diseased cells. This is a blank area in medicine. Summary of the Invention

[0005] To address the aforementioned issues, this application provides a temperature-controllable magnetically separated infusion vessel.

[0006] The first objective of this application is to provide a temperature-controllable magnetically separated infusion tube, comprising an inner tube and an outer sleeve sleeved around the outer periphery of the inner tube; The gap between the inner tube and the outer sleeve is configured as a first channel for transporting cooling medium, and the inner tube is configured to transport blood to be separated. One end of the inner tube is provided with a stop-reverse tip, and a stop-reverse bead is provided on one side of the stop-reverse tip. In the direction of blood transport, the stop-reverse bead and the stop-reverse tip are arranged in sequence.

[0007] In a specific embodiment of this application, the inner tube wall material is filled with magnetic particles.

[0008] In a specific embodiment of this application, the particle size of the magnetic particles ranges from 100 nanometers to 100 micrometers.

[0009] In a specific embodiment of this application, the magnetic particles fill 5% to 40% of the wall material of the inner tube.

[0010] In a specific embodiment of this application, the magnetic particles are particles with a magnetic coating on their outer surface, and the magnetic coating is composed of biocompatible materials and magnetic materials.

[0011] In a specific embodiment of this application, the substrate of the inner tube wall material is one of medical-grade polyvinyl chloride, silicone rubber, thermoplastic polyurethane, nylon, and block polyether amide.

[0012] In a specific embodiment of this application, the wall material of the outer sleeve is one of foamed polyethylene, foamed polyurethane, nylon, polyvinyl chloride, silicone rubber, thermoplastic polyurethane, and block polyether amide.

[0013] In a specific embodiment of this application, the inner tube is provided with a blood inlet and a blood outlet at its two ends, respectively; The inner tube is provided with an elution inlet and an elution outlet; The outer sleeve is provided with a water-cooling inlet and a water-cooling outlet; In the blood transport direction, the blood inlet, the elution inlet, the water-cooling inlet, the water-cooling outlet, the elution outlet, and the blood outlet are arranged in sequence.

[0014] In a specific embodiment of this application, the inner wall surface of the inner tube is coated with a lubricating coating.

[0015] In a specific embodiment of this application, the material of the lubricating coating is parylene or a choline phosphate polymer.

[0016] In a specific embodiment of this application, a magnetic field generating device is also provided outside the blood transfusion channel.

[0017] In a specific embodiment of this application, the magnetic field generating device is a blood cell separation magnet device.

[0018] Compared with the prior art, this application has the following advantages: First, to prevent magnetized cells or large non-magnetic particles from entering the later stage of blood circulation: This application uses the anti-reverse bead and the anti-reverse tip to work together to allow blood to pass through only, preventing magnetized cells or large non-magnetic particles from entering the later stage of blood circulation; Second, active and precise cooling: The first channel in the temperature-controllable magnetic separation transfusion tube of this application directly cools the blood flowing through the inner tube, with high and uniform cooling efficiency, minimizing the heat exposure of the blood along the path and reducing the risk of heat damage.

[0019] Thirdly, magnetic navigation and maneuverability: The magnetic particles in the inner tube wall material allow the inner tube to be precisely guided and positioned by an external magnetic field. In minimally invasive surgery, this enables remote, contactless bending and fixation of the tube, improving the flexibility and precision of the procedure.

[0020] Fourth, blood flow optimization: The magnetic particles uniformly dispersed in the inner tube wall can increase damping, reduce blood flow velocity, and generate micro-vibrations under the action of pulsating magnetic field, which helps to reduce blood stagnation in the boundary layer and inhibit thrombus formation.

[0021] Fifth, the integrated structure combines cooling and magnetic navigation functions into a single pipeline structure, simplifying the configuration of the extracorporeal circulation pipeline and improving the system's integration and reliability.

[0022] Other features and advantages of this application will be set forth in the description which follows, and will be apparent in part from the description, or may be learned by practicing the application. The objectives and other advantages of this application may be realized and obtained by means of the structures pointed out in the description, claims and drawings. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of this application or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0024] Figure 1 A schematic diagram of a temperature-controllable magnetically separated infusion vessel is shown according to certain embodiments of this application; Figure 2 It shows Figure 1 The cross-sectional view at point AA.

[0025] Figure 3 The mounting bracket is shown in some embodiments of this application; Figure 4 A schematic diagram of the structure of a blood cell separation magnet device according to certain embodiments of this application is shown; In the picture: 1. Inner tube; 2. Outer sleeve; 3. Check valve tip; 4. Check valve bead; 5. Water-cooled inlet; 6. Water-cooled outlet; 7. First channel; 8. Magnetic particles; 9. Second channel; 10. Elution inlet; 11. Elution outlet; 12. Blood inlet; 13. Blood outlet; 14. Fixation support; 20. Housing; 21. Runway coil; 22. Hinge; 23. Heat dissipation mechanism; 24. Pole head; 25. Piping; 26. Locking mechanism; 27. Working area. Detailed Implementation

[0026] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0027] like Figure 1 As shown, a temperature-controllable magnetic separation transfusion channel according to certain embodiments of the present invention includes an inner tube 1 and an outer sleeve 2 sleeved around the outer periphery of the inner tube 1. The gap between the inner tube 1 and the outer sleeve 2 is configured as a first channel 7 (see details). Figure 2 It is used to transport cooling medium, which can directly and efficiently cool the blood flowing through the inner tube 1 in a uniform circumferential manner, avoiding the problem of blood thermal damage caused by blood temperature rise; The inner tube 1 is configured to transport the blood to be separated, for example, such as... Figure 2 The second channel 9 is shown; One end of the inner tube 1 is provided with a stop-reverse tip 3, and a stop-reverse bead 4 is provided on one side of the stop-reverse tip 3. In the direction of blood transport, the stop-reverse bead 4 and the stop-reverse tip 3 are arranged in sequence. The anti-reverse bead 4 and the anti-reverse tip 3 work together to allow only non-magnetized blood cells to pass through, preventing magnetized cells or larger non-magnetic particles from entering the later blood circulation.

[0028] In some embodiments of this application, the inner tube 1 is filled with magnetic particles 8 in its wall material so that the magnetized cells in the blood to be separated are adsorbed onto the wall of the inner tube 1, thereby further achieving the purpose of separating the magnetized cells in the blood.

[0029] In some embodiments of this application, the anti-reverse bead 4 is a magnetic ball or a non-magnetic ball.

[0030] In some embodiments of this application, the cooling medium is, for example, 4°C physiological saline.

[0031] In some embodiments of this application, the diameter of the inner tube 1 may be designed to be 3 / 16 inch to 3 / 8 inch (4.8 mm to 9.5 mm) according to clinical needs (such as adults or children).

[0032] In some embodiments of this application, the wall thickness of the inner tube 1 is 0.5 mm to 1.5 mm.

[0033] In some embodiments of this application, the inner wall of the outer sleeve 2 and the outer wall of the inner tube 1 are bonded together by spaced micro-biocompatible adhesive dots to form a stable and unobstructed first channel 7; wherein, the biocompatible adhesive is an adhesive well known in the art and is not specifically limited in this application.

[0034] In some embodiments of this application, the wall thickness of the outer sleeve 2 is 1 mm to 3 mm.

[0035] In some embodiments of this application, the particle size of the magnetic particles 8 ranges from 100 nanometers to 100 micrometers.

[0036] In some embodiments of this application, the magnetic particles 8 are filled in the wall material of the inner tube 1 at a percentage of 5% to 40%.

[0037] In some embodiments of this application, the magnetic particle 8 is a particle with a magnetic coating on its outer surface, and the magnetic coating is composed of biocompatible materials and magnetic materials. The magnetic material is selected from one or a mixture of several of magnetite, neodymium iron boron, bearing steel and other materials with magnetization ability in any proportion; The biocompatible material is selected from one of inert silica, polyurethane (PU), polytetrafluoroethylene (PTFE), polysulfonated betaine (PSBMA), and polycarboxylated betaine (PCBMA).

[0038] In some embodiments of this application, the substrate of the inner tube 1 wall material is one of medical-grade polyvinyl chloride, silicone rubber, thermoplastic polyurethane, nylon, and block polyether amide.

[0039] In some embodiments of this application, the wall material of the outer sleeve 2 is one of foamed polyethylene, foamed polyurethane, nylon, polyvinyl chloride, silicone rubber, thermoplastic polyurethane, and block polyether amide. For example, closed-cell foamed polyurethane material is used, which has good thermal insulation performance, prevents cold loss and avoids condensation on the outer surface.

[0040] In some embodiments of this application, the inner tube 1 is provided with a blood inlet 12 and a blood outlet 13 at both ends, the blood inlet 12 being used to input blood to be separated, and the blood outlet 13 being used to discharge separated blood.

[0041] In some embodiments of this application, the inner tube 1 is provided with an elution inlet 10 and an elution outlet 11, both of which penetrate the tube wall of the outer sleeve 2 and are used to elute the refined cells adsorbed in the inner tube 1.

[0042] In some embodiments of this application, the outer sleeve 2 is provided with a water-cooled inlet 5 and a water-cooled outlet 6. The water-cooled inlet 5 and the water-cooled outlet 6 are respectively connected to the supply pipe and return pipe of the cooling medium, forming an independent cooling circulation loop.

[0043] In some embodiments of this application, the blood inlet 12, the elution inlet 10, the water-cooling inlet 5, the water-cooling outlet 6, the elution outlet 11, and the blood outlet 13 are arranged sequentially in the blood transport direction.

[0044] In some embodiments of this application, the inner wall surface of the inner tube 1 is coated with a lubricating coating to further reduce blood adhesion and friction.

[0045] In some embodiments of this application, the material of the lubricating coating is parylene or a choline phosphate polymer.

[0046] In some embodiments of this application, a magnetic field generating device is also provided outside the blood transfusion channel.

[0047] In some embodiments of this application, the magnetic field generating device is a blood cell separation magnet device, which includes: a plurality of symmetrically arranged pole heads 24, and a racetrack coil 21 is provided outside the pole heads 24 (see details). Figure 4 ); The runway coil 21 refers to a coil whose planar shape is composed of two parallel long straight side segments and two semi-circular arc ends connecting the long straight side segments; The central axis of the gap formed between the runway coils 21 is the working area 27; The dimensions of the working area 27 are: width of 8~15mm and length of 200~500mm.

[0048] In some embodiments of this application, the magnetic field strength of the working area 27 is made greater than or equal to 0.5 T by adjusting the DC current in the runway coil 21, so as to achieve efficient capture of magnetized cells flowing through the working area 27; The runway coil 21 and the pole head 24 are fixed in several layout areas, and the number of runway coils 21 and pole heads 24 in each layout area are equal to facilitate the installation and assembly of the magnet device.

[0049] In some embodiments of this application, a housing 20 is provided on the outer periphery of the deployment area, and the housings 20 of several deployment areas are combined to form a complete box, forming an openable box structure. A locking mechanism 26 is provided on adjacent openable housings 20 in the complete box. For example, the number of pole heads 24 is two, and the number of runway coils 21 is two; One of the pole heads 24 has a runway coil 21 arranged around its periphery, forming a layout area (with a housing 20 outside the layout area), and another runway coil 21 arranged around its periphery, forming another layout area (with a housing 20 outside the layout area). One housing 20 and the other housing 20 are connected by a hinge 22; The runway coil 21 is provided with a heat dissipation mechanism 23 around its periphery. For example, the heat dissipation mechanism 23 is a liquid cooling plate or a heat dissipation block. For example, the heat dissipation mechanism 23 is a copper water-cooled plate with microchannels, and the copper water-cooled plate is connected to an external circulating cooler through a pipe 25.

[0050] In some embodiments of this application, the pipe is connected to a fixed bracket 14 (see details). Figure 3 It is fixed in the working area 27 of the blood cell separation magnet device and is installed and fixed in conjunction with the blood cell separation magnet device during use.

[0051] The working process of the transfusion tube in this embodiment is as follows: During use, the transfusion tube is connected between the blood pump of the extracorporeal circulation system and the patient's cannula, and placed in an external magnetic field. The cooling circulation is activated, allowing low-temperature saline to flow continuously in the first tube. Simultaneously, the external magnetic field generator is brought close to the patient's surgical area. By adjusting the direction and intensity of the magnetic field, magnetic particles in the inner tube 1 and magnetized cells in the blood to be separated can be guided and fixed in real time, precisely filtering diseased cells. After a certain amount of magnetized cells are adsorbed and fixed, the blood inlet 12 and blood outlet 13 are closed, the elution inlet 10 and elution outlet 11 are opened, the magnetic field is turned off, and the inner tube 1 is rinsed with saline to wash away the adsorbed and fixed magnetized cells, completing the treatment process.

[0052] Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A temperature-controllable magnetically separated infusion vessel, characterized in that, It includes an inner tube (1) and an outer sleeve (2) sleeved around the outer periphery of the inner tube (1); The gap between the inner tube (1) and the outer sleeve (2) is set as a first channel (7) and used to transport the cooling medium. The inner tube (1) is set to transport the blood to be separated. One end of the inner tube (1) is provided with a stop-reverse tip (3), and a stop-reverse bead (4) is provided on one side of the stop-reverse tip (3). In the direction of blood transport, the stop-reverse bead (4) and the stop-reverse tip (3) are arranged in sequence.

2. The temperature-controllable magnetic separation infusion channel according to claim 1, characterized in that, The inner tube (1) is filled with magnetic particles (8) in its wall material.

3. The temperature-controllable magnetic separation infusion channel according to claim 2, characterized in that, The magnetic particles (8) have a particle size range of 100 nanometers to 100 micrometers.

4. The temperature-controllable magnetic separation pipe according to claim 2, characterized in that, The magnetic particles (8) are filled in the wall material of the inner tube (1) at a percentage of 5% to 40%.

5. A temperature-controllable magnetically separated infusion vessel according to claim 2, characterized in that, The magnetic particles (8) are particles with a magnetic coating on their outer surface, and the magnetic coating is composed of biocompatible materials and magnetic materials.

6. The temperature-controllable magnetic separation infusion vessel according to claim 1, characterized in that, The substrate of the inner tube (1) wall material is one of medical grade polyvinyl chloride, silicone rubber, thermoplastic polyurethane, nylon, and block polyether amide.

7. The temperature-controllable magnetic separation infusion vessel according to claim 1, characterized in that, The wall material of the outer sleeve (2) is one of foamed polyethylene, foamed polyurethane, nylon, polyvinyl chloride, silicone rubber, thermoplastic polyurethane, and block polyether amide.

8. A temperature-controllable magnetically separated infusion vessel according to claim 1, characterized in that, The inner tube (1) is provided with a blood inlet (12) and a blood outlet (13) at both ends. The inner tube (1) is provided with an elution inlet (10) and an elution outlet (11); The outer sleeve (2) is provided with a water-cooling inlet (5) and a water-cooling outlet (6). In the direction of blood transport, the blood inlet (12), the elution inlet (10), the water cooling inlet (5), the water cooling outlet (6), the elution outlet (11), and the blood outlet (13) are arranged in sequence.

9. A temperature-controllable magnetically separated infusion vessel according to claim 1, characterized in that, The inner wall surface of the inner tube (1) is coated with a lubricating coating.

10. A temperature-controllable magnetically separated infusion vessel according to claim 9, characterized in that, The material of the lubricating coating is poly(p-xylene) or a choline phosphate polymer.

11. A temperature-controllable magnetically separated infusion vessel according to any one of claims 1-10, characterized in that, A magnetic field generating device is also installed outside the blood transfusion channel.

12. A temperature-controllable magnetically separated infusion vessel according to claim 11, characterized in that, The magnetic field generating device is a blood cell separation magnet device, which has several symmetrically arranged poles (24), and a racetrack coil (21) is provided outside the poles (24). The central axis of the gap formed between several runway coils (21) is the working area (27). The magnetic separation transfusion channel is fixed within the working area (27).

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