Pump cable of blood pump for connecting artificial heart auxiliary device

Abstract

The invention belongs to the technical field of medical apparatus and instruments, and discloses a blood pump cable for connecting an artificial heart auxiliary device, the blood pump cable comprises a transmission cable, a first functional layer and a second functional layer, the transmission cable is sequentially coated with the first functional layer and the second functional layer, and an area between an inner cavity of the first functional layer and the transmission cable is filled with an elastic filling material. The artificial tooth is simple in structure, good in flexibility, long in bending fatigue resistance life, good in biocompatibility and high in practicability.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a blood pump cable for connecting an artificial heart assist device. Background Art

[0002] Artificial heart assist device is an important medical device that can provide effective treatment and support for patients with end-stage heart failure, assist or replace the heart work of patients with end-stage heart failure, so as to achieve normal blood supply to the human body. The blood pump is the core component of the artificial heart assist device implanted in the human body, which can assist or completely replace the heart function to promote blood circulation. The external part of the artificial heart assist device mainly includes a drive device, a monitoring system, a power device and a controller. Among them, the drive device provides power for the blood pump to ensure its normal and continuous operation; the monitoring system monitors the working status of the artificial heart assist device in real time through various sensors; the power device provides energy for the artificial heart assist device, which is usually a lithium-ion battery; the controller mainly monitors the heart's beating speed and monitors the patient's vital signs, adjusts blood flow, etc., and maintains the stable operation of the artificial heart assist device through precise control and regulation.

[0003] In an artificial heart assist device, the pump cable is an important structure that connects the blood pump in the body and components such as an external controller. One end of the cable is connected to the blood pump, and the other end passes through the human body and is connected to components such as an external controller. The pump cable transmits power and signals to ensure that the blood pump can work normally.

[0004] As an important structure of the artificial heart assist device, the performance of the pump cable plays a vital role in the normal operation of the artificial heart assist device and the safety of the patient. If the pump cable is not flexible, it will compress the patient's body and cause discomfort to the patient. In actual use, the blood pump needs to work continuously for a long time. If the bending fatigue life of the pump cable is not high, its stability during repeated bending and stretching cannot be guaranteed, which can easily lead to damage to the pump cable and cannot ensure the stable operation of the equipment. Summary of the invention

[0005] The object of the present invention is to provide a blood pump cable for connecting an artificial heart assist device, which has a simple structure, good flexibility, high bending fatigue life, good biocompatibility and strong practicality.

[0006] The technical solution adopted by the present invention to solve its technical problem is: a blood pump cable for connecting an artificial heart assist device, including a transmission cable, and also including a first functional layer and a second functional layer sequentially wrapped around the outside of the transmission cable, and the area between the inner cavity of the first functional layer and the transmission cable is filled with elastic filling material.

[0007] Furthermore, one or more tensile fiber threads are embedded in the elastic filling material.

[0008] Furthermore, a water inlet pipe and a water outlet pipe are embedded in the elastic filling material.

[0009] Furthermore, the water inlet pipe includes an inner water inlet pipe and an outer water inlet pipe wrapped around the outer periphery of the inner water inlet pipe; the water outlet pipe includes an inner water outlet pipe and an outer water outlet pipe wrapped around the outer periphery of the inner water outlet pipe.

[0010] Furthermore, the transmission cable includes a cable inner layer and a cable outer layer wrapped around the outer periphery of the cable inner layer; it also includes a wire core arranged in the inner cavity of the cable inner layer, and the wire core includes a central conductor and an insulating layer wrapped around the outer periphery of the central conductor.

[0011] Furthermore, the central conductor is formed by twisting a plurality of thin-filament conductors.

[0012] Furthermore, a lubricating layer is provided on the peripheries of the transmission cable, the water inlet pipe and the water outlet pipe which are in contact with the elastic filling material.

[0013] The beneficial effects of the present invention are:

[0014] 1. The first functional layer of the present invention has extremely high elasticity, wear resistance, mechanical strength, and good low temperature resistance, oil resistance, water resistance and weather resistance, which can ensure the safety of patients during use;

[0015] 2. The second functional layer of the present invention has high mechanical strength and good biocompatibility. After being implanted in the human body, it will not cause irritation or rejection reaction to human tissues. It has good stability and is suitable for long-term implantation in the human body.

[0016] 3. The elastic filling material of the present invention has strong resilience and tensile strength, which can ensure that the pump cable can better restore to its original state when subjected to external force, and can withstand large external forces without being easily damaged, thereby ensuring its stability;

[0017] 4. The tensile strength-resistant fiber line embedded in the elastic filling material of the present invention has extremely high tensile strength. After being embedded in the elastic filling material, the tensile strength of the pump cable can be improved, making the pump cable as a whole less likely to break;

[0018] 5. In the present invention, a water inlet pipe and a water outlet pipe are embedded in the elastic filling material to realize water circulation, which can effectively take away the heat for heat dissipation, keep the temperature of the pump cable within a suitable range, and avoid performance degradation or damage caused by overheating;

[0019] 6. The overall structure of the present invention is simple, and the coordination of various components makes the pump cable have good flexibility, high bending fatigue resistance, good biocompatibility and strong practicality. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the present invention will be further described below in conjunction with the accompanying drawings and embodiments. The drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work:

[0021] Figure 1 It is a cross-sectional schematic diagram of the structure of the present invention.

[0022] Figure 2 This is a graph showing the changes in resistance values ​​of 11 pump cable samples after 100,000 bendings.

[0023] Figure 3 This is a graph showing the changes in resistance values ​​of 11 pump cable samples after 200,000 bendings.

[0024] Figure 4 This is a graph showing the changes in resistance values ​​of 11 pump cable samples after 400,000 bendings.

[0025] Figure 5 This is a graph showing the changes in resistance values ​​of 11 pump cable samples after 500,000 bendings.

[0026] In the figure: 1. Transmission cable; 2. First functional layer; 3. Second functional layer; 4. Elastic filling material; 5. Tensile fiber line; 6. Water inlet pipe; 7. Water outlet pipe;

[0027] 101. Cable inner layer; 102. Cable outer layer; 103. Wire core;

[0028] 601. Inner water inlet pipeline; 602. Outer water inlet pipeline;

[0029] 701. Inner water outlet pipeline; 702. Outer water outlet pipeline;

[0030] 131. Center conductor; 132. Insulation layer. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the following will be described clearly and completely in combination with the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are partial embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work belong to the protection scope of the present invention.

[0032] A blood pump cable for connecting an artificial heart assist device comprises a transmission cable 1, and also comprises a first functional layer 2 and a second functional layer 3 sequentially coated on the outside of the transmission cable 1, and the area between the inner cavity of the first functional layer 2 and the transmission cable 1 is filled with an elastic filling material 4. The transmission cable 1 in the present invention mainly plays the role of transmitting electrical energy and / or signals.

[0033] The first functional layer 2 is TPU (thermoplastic polyurethane) material, which has extremely high elasticity, wear resistance and mechanical strength, and also has good low temperature resistance, oil resistance, water resistance and weather resistance. In addition, TPU material is environmentally friendly and non-toxic, which can ensure the safety of patients during use.

[0034] The second functional layer 3 is made of PCU (polycarbonate-based polyurethane) material, which has high mechanical strength, can withstand large stress and deformation, and has excellent elasticity, and can quickly recover to its original state after being subjected to external force. In addition, one end of the pump cable needs to be implanted in the human body when in use. If the biocompatibility of the pump cable is poor, the pump cable is prone to cause adverse biological reactions such as inflammation and allergies when in contact with human tissues, cells and blood. The PCU material also has good biocompatibility. When it is implanted into the human body as the outermost layer of the pump cable, it will not cause irritation or rejection reactions to human tissues. It has good stability and is suitable for long-term implantation in the human body.

[0035] The elastic filling material 4 is SEPS (hydrogenated styrene / isoprene copolymer) elastic material. The SEPS material has strong resilience and tensile strength, which can ensure that the pump cable can better restore its original shape when subjected to external force, and can withstand large external forces without being easily damaged, thereby ensuring its stability.

[0036] The transmission cable 1 in the present invention includes a cable inner layer 101 and a cable outer layer 102 coated on the outer periphery of the cable inner layer 101; it also includes a wire core 103 arranged in the inner cavity of the cable inner layer 101, and the wire core 103 includes a central conductor 131 and an insulating layer 132 coated on the outer periphery of the central conductor 131.

[0037] The number of the wire cores 103 is more than one, and is selected according to actual needs. In a preferred embodiment of the present invention, the number of the wire cores 103 is five, that is, the transmission cable 1 of the present invention is a five-core cable. In actual work, some of the five wire cores 103 can be used to transmit electricity to provide the necessary power for the blood pump to ensure its normal operation; some of the wire cores 103 are used to transmit control signals or monitoring signals, which can come from the control system of the blood pump or external monitoring equipment. Through the transmission of these signals, accurate control and real-time monitoring of the blood pump can be achieved to ensure the stability and safety of its operating state.

[0038] The center conductor 131 is formed by twisting a plurality of thin filament conductors. This method can improve the tensile strength and wear resistance of the center conductor 131. Compared with a single thick conductor, the twisted conductor has better flexibility and is easy to bend and deform. In a preferred embodiment of the present invention, the center conductor 131 is a silver-plated copper alloy, and each conductor is formed by twisting more than 150 thin filament conductors.

[0039] The insulating layer 132 is made of ETFE (ethylene-tetrafluoroethylene copolymer) insulating material, which has high dielectric strength, high thermal stability and mechanical strength, and can also resist corrosion from a variety of chemical substances such as acids and alkalis, thereby ensuring the normal operation and safety of the device of the present invention. In order to facilitate distinction, the insulating layers 132 of the multiple cores 103 can be set to different colors during design. In this embodiment, the colors of the insulating layers 132 of the five cores 103 can be selected from five colors: white, red, black, green and brown.

[0040] The inner layer 101 of the cable is a PES (polyester) binding tape, and the outer layer 102 of the cable is a PVC (polyvinyl chloride) material. During the actual processing of the transmission cable 1, a number of filament conductors are first twisted into a central conductor 131, and then a PES binding tape is wrapped around the periphery of the central conductor 131, and finally a PVC outer layer is wrapped around the outside of the PES binding tape. PES has good insulation properties. Wrapping the PES binding tape around the periphery of the central conductor 131 can effectively prevent current leakage and short circuit, ensuring the safe use of the conductor. PVC material has good insulation, corrosion resistance, weather resistance and flame retardancy. The outer layer 102 of the cable is a PVC material, which can effectively protect the internal conductor from erosion by the external environment, and can also prevent the conductor from being mechanically damaged during transportation and use. The PES and PVC of the present invention are both insulating materials. The use of the two in combination can further enhance the insulation performance of the conductor, and can also increase the mechanical strength of the conductor, making it more durable and less prone to damage.

[0041] In the present invention, more than one tensile fiber line 5 is embedded in the elastic filling material 4. The tensile fiber line 5 embedded in the elastic filling material 4 in the present invention has extremely high tensile strength. After being embedded in the elastic filling material 4, the tensile strength of the pump cable can be improved, so that the pump cable as a whole is not easy to break. After adding the tensile fiber line 5, the softness and flexibility of the pump cable can also be improved, so that the pump cable can still maintain good performance under complex actions such as bending and twisting, and it is not easy to break or damage. The blood pump cable of the present invention needs to be frequently moved or changed in shape during actual use. After adding the tensile fiber line 5 to improve the softness and flexibility of the pump cable, the use efficiency and reliability of the pump cable can be improved. The material of the tensile fiber can be selected from Kevlar fiber or high-strength polyethylene fiber, etc., and Kevlar fiber is preferred in the present invention. In actual design, the number of tensile fiber lines 5 can be selected according to actual needs. In a preferred embodiment of the present invention, the number of tensile fiber lines 5 is two, and they are randomly distributed in the elastic filling material 4 in the inner cavity of the first functional layer 2.

[0042] In the present invention, a water inlet pipe 6 and a water outlet pipe 7 are also embedded in the elastic filling material 4. During operation, the blood pump may generate heat due to the passage of current and mechanical friction. The water circulation through the water inlet pipe 6 and the water outlet pipe 7 can effectively take away the heat for heat dissipation, keep the temperature of the pump cable within an appropriate range, and avoid performance degradation or damage caused by overheating.

[0043] The water inlet pipe 6 includes an inner water inlet pipe 601 and an outer water inlet pipe 602 coated on the outer periphery of the inner water inlet pipe 601. The water outlet pipe 7 includes an inner water outlet pipe 701 and an outer water outlet pipe 702 coated on the outer periphery of the inner water outlet pipe 701. The inner water inlet pipe 601 and the inner water outlet pipe 701 have the same material and thickness, both of which are 0.1 mm PVDF (polyvinylidene fluoride) polymer coatings. The PVDF material has extremely high resistance to chemicals such as strong acids, strong alkalis, organic solvents and oxidants, and also has good impact resistance, tensile resistance and creep resistance. In addition, the surface of the PVDF material is not easy to adhere to dirt, and using it as the inner coating of the water inlet pipe 6 and the water outlet pipe 7 can maintain the cleanliness of the pipeline.

[0044] The water inlet outer layer pipe 602 and the water outlet outer layer pipe 702 have the same material and thickness, both of which are TPU (thermoplastic polyurethane) materials. The hardness of TPU material is much higher than the hardness range of ordinary rubber, and it can still maintain elasticity even at a Shore hardness of more than 85. In addition, TPU material has high strength and high elongation, which can ensure that the cable has flexibility while ensuring its mechanical strength.

[0045] In the present invention, the outer peripheries of the transmission cable 1, the water inlet pipe 6 and the water outlet pipe 7 in contact with the elastic filling material 4 are all provided with a lubricating layer, which is not drawn in the figure. The lubricating layer is silicone oil, which can play a lubricating role when assembling the internal parts of the pump cable.

[0046] The pump cable of the present invention is suitable for long-term implantation in the human body, and the selection of materials meets the various standards for implantation in the human body in IOS10993; after a left and right 90-degree swing test, it was found that the bending durability of the present invention is greater than 400,000 times; the minimum bending radius also successfully passes the extreme bending situation encountered during simulation of human activities. In addition, during the tensile strength test of the pump cable, according to the weight of the connected external controller of 3kg, the present invention sets a safety factor of 3.3 times, that is, under a tensile test of 10kg, the pump cable can be used normally without any cracking or damage.

[0047] Pump cable bending durability test

[0048] 1. Purpose of the test

[0049] The pump cable is bent repeatedly to understand the actual bending durability of the internal wires and the CS water inlet pipe 6 and the water outlet pipe 7, and to verify whether the pump cable can withstand the number of bending times in actual use and the reliability with a confidence level of 90% and a reliability L level of 80%.

[0050] 2. Eligibility criteria

[0051] The criterion is 100,000 bends, and the sources of this criterion are as follows:

[0052] Set the number of bending times (10 times / day) × 2 years (730 days) × safety factor (10) = 73000 (times)

[0053] Considering the further safety, the standard value for judging whether the bending endurance is qualified is set at 100,000 times. In addition, considering the deviation of the test results, the safety factor is set at 10.

[0054] 3. Experimental items

[0055] The blood pump cable (part number 12930-01) for connecting an artificial heart assist device of the present invention is tested using 11 pump cables for different bending times.

[0056] Production date: 2024-06-07 150m (molded on June 17, 2024)

[0057] 4. Test equipment

[0058] The following equipment was used for testing.

[0059] Resistance meter (Manufacturer: Tsuruga Electric, Model: 3565-04, Meter management No. M-E1110)

[0060] Pressure gauge (Manufacturer: Copal Electronics, Model: PG-208-103G-S, Meter Management No. M-P3007)

[0061] Thermohygrometer (Manufacturer: sekonic, Model: ST-50, Meter Management No. M-P5045)

[0062] Six-connection cable bending endurance testing machine (DBS-2010-06).

[0063] 5. Experimental methods and data

[0064] The six-link cable bending endurance tester used in this test is an accelerated test device that can bend the pump cable of the present invention at any angle and can determine the disconnection situation. By swinging the bending point left and right, a load can be applied to the object being tested. In addition, the resistance can be recorded by the resistance tester in the device, and it also has a counter function. The experimental results are as follows:

[0065] (1) The resistance value and water leakage test results after 100,000 bending cycles are shown in Table 1 and Figure 2 As shown, during the test, all pump cables had no power cord disconnection and no water inlet pipe 6 and outlet pipe 7 leaked.

[0066] Table 1.1 million times bending resistance and water leakage test results

[0067]

[0068] (2) The resistance value and water leakage test results after 200,000 bends are shown in Table 2 and Figure 3 As shown, during the test, all pump cables had no power cord disconnection and no water inlet pipe 6 and outlet pipe 7 leaked.

[0069] Table 2.2 million bending resistance and water leakage test results

[0070]

[0071]

[0072] (3) The resistance value and water leakage test results after 400,000 bends are shown in Table 3 and Figure 4 As shown, during the test, all pump cables had no power cord disconnection and no water inlet pipe 6 and outlet pipe 7 leaked.

[0073] Table 3.4 million bending resistance and water leakage test results

[0074]

[0075] According to Tables 1 to 3 above and Figures 2 to 4 The results show that even if the cable of the present invention is bent 400,000 times, the cable conductivity of each sample is still normal, and the pure water sealing liquid tube is pressure-resistant without leakage.

[0076] Based on the above results, it can be seen that the present invention has a good result of 400,000 times. Therefore, an additional 500,000-time bending test was performed to confirm the wire breakage and the state of the fluorinated olefin in the inner layer of the pure water sealing liquid tube.

[0077] (4) The resistance value and water leakage test results after 500,000 bends are shown in Table 4 and Figure 5 As shown, during the test, all pump cables had no power cord disconnection and no water inlet pipe 6 and outlet pipe 7 leaked.

[0078] Table 4.5 million bending resistance and water leakage test results

[0079]

[0080]

[0081] After 500,000 bends, cracks were confirmed on the PVDF surfaces of the water inlet inner layer pipe 601 and the water outlet inner layer pipe 701 of Test Nos. 3, 4, 7, 8, 9, and 10.

[0082] 5. Experimental conclusion

[0083] (1) Bending durability

[0084] The plurality of pump cables of the present invention all meet the pass / fail judgment standard of 100,000 bending times, and prove the reliability of 90% confidence level and 80% reliability L grade.

[0085] (2) Bending durability of power cord

[0086] No wire breakage was found in any of the 11 test pieces that were bent between 100,000 and 500,000 times. Therefore, reliability durability was proven at a confidence level of 90% and a reliability level of 80%.

[0087] (3) Bending durability and leakage confirmation test of pure water sealing liquid pipe

[0088] All test pieces (pure water sealing liquid tubes) were checked and no water leakage was found. When the bending frequency reached 500,000 times, cracks and peeling were confirmed on the surface of the inner PVDF layer.

[0089] When the bending times ranged from 100,000 to 400,000 times, all test specimens showed no leakage, cracking or peeling of the PVDF surface. Therefore, reliability and durability were proven at a confidence level of 90% and a reliability level of 80%.

[0090] In addition, as an additional test, no leakage was found when the test object was bent 500,000 times, but cracks were confirmed on the surface of the PVDF inner layer of the pure water sealing liquid tube. Therefore, the bending durability of the pure sealing liquid tube is considered to be 400,000 times. The service life of 400,000 bending times is more than 10 years, which is good in practicality and strong in stability.

[0091] The specific implementation methods described above further illustrate the objectives, technical solutions and beneficial effects of the present invention in detail. It should be understood that the above description is only a specific implementation method of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the scope of the present invention should be included in the protection scope of the present invention.

Claims

1. A blood pump cable for connecting an artificial heart assist device, characterized in that: It comprises a transmission cable (1), and also comprises a first functional layer (2) and a second functional layer (3) which are sequentially coated on the outside of the transmission cable (1), and the area between the inner cavity of the first functional layer (2) and the transmission cable (1) is filled with an elastic filling material (4).

2. The blood pump cable for connecting an artificial heart assist device according to claim 1, characterized in that: One or more tensile fiber threads (5) are embedded in the elastic filling material (4).

3. The blood pump cable for connecting an artificial heart assist device according to claim 1 or 2, characterized in that: A water inlet pipe (6) and a water outlet pipe (7) are also embedded in the elastic filling material (4).

4. The blood pump cable for connecting an artificial heart assist device according to claim 3, characterized in that: The water inlet pipe (6) comprises a water inlet inner layer pipeline (601) and a water inlet outer layer pipeline (602) wrapped around the outer periphery of the water inlet inner layer pipeline (601); the water outlet pipe (7) comprises a water outlet inner layer pipeline (701) and a water outlet outer layer pipeline (702) wrapped around the outer periphery of the water outlet inner layer pipeline (701).

5. The blood pump cable for connecting an artificial heart assist device according to claim 1, 2 or 4, characterized in that: The transmission cable (1) comprises a cable inner layer (101) and a cable outer layer (102) coated around the outer periphery of the cable inner layer (101); and further comprises a wire core (103) arranged in the inner cavity of the cable inner layer (101), wherein the wire core (103) comprises a central conductor (131) and an insulating layer (132) coated around the outer periphery of the central conductor (131).

6. The blood pump cable for connecting an artificial heart assist device according to claim 3, characterized in that: The transmission cable (1) comprises a cable inner layer (101) and a cable outer layer (102) coated around the outer periphery of the cable inner layer (101); and further comprises a wire core (103) arranged in the inner cavity of the cable inner layer (101), wherein the wire core (103) comprises a central conductor (131) and an insulating layer (132) coated around the outer periphery of the central conductor (131).

7. The blood pump cable for connecting an artificial heart assist device according to claim 5, characterized in that: The central conductor (131) is formed by twisting a plurality of thin-filament conductors.

8. The blood pump cable for connecting an artificial heart assist device according to claim 6, characterized in that: The central conductor (131) is formed by twisting a plurality of thin-filament conductors.

9. The blood pump cable for connecting an artificial heart assist device according to claim 3, characterized in that: The outer circumferences of the transmission cable (1), the water inlet pipe (6) and the water outlet pipe (7) in contact with the elastic filling material (4) are all provided with a lubricating layer.

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