In vivo non-implanted defibrillation cable

Abstract

This application relates to the field of medical cable technology, specifically an in-body non-implantable defibrillator cable, comprising two cable groups; each cable group consists of a core group, a wrapping tape, and a sheath from the inside out; the core group includes a high-voltage conductor, two signal lines, and several tensile filler wires; wherein, the tensile filler wires are filled within the wrapping tape and positioned in the gap formed by the high-voltage conductor and the signal lines. In use, one end of each of the two high-voltage conductors is connected to the defibrillator, and the other end is connected to the defibrillator electrode pads; by grouping the two high-current high-voltage conductors and four signal lines in the cable and laying them separately within two independent sheaths connected by connectors, it is very effective to ensure that when the high current passes through the high-voltage conductors during defibrillator use, high-voltage line breakdown, short circuits, or creepage are avoided, which can greatly reduce the risk of accidents, and the parallel straight cable is more suitable for cleaning and disinfection.

Description

Technical Field

[0001] This application relates to the field of medical cable technology, and in particular to an in-vivo non-implantable defibrillation cable. Background Technology

[0002] During cardiac defibrillation and cardioversion, a short, high-energy pulse is applied to the heart, typically lasting 4–10 ms, with an electrical energy of 40–400 J (joules). The device used for this electrical shock is called a defibrillator, which performs the defibrillation procedure. When a patient experiences severe rapid arrhythmias, such as atrial flutter, atrial fibrillation, supraventricular or ventricular tachycardia, it often causes varying degrees of hemodynamic disturbances. Especially when ventricular fibrillation occurs, because the ventricles lack overall contractile ability, cardiac ejection and blood circulation cease. Without timely intervention, this often leads to death due to prolonged cerebral hypoxia. Using a defibrillator, a controlled current of a certain energy is passed through the heart, eliminating certain arrhythmias and restoring the heart rhythm to normal, thus enabling the rescue and treatment of patients with the aforementioned heart conditions.

[0003] Original defibrillators used industrial alternating current (AC) for direct defibrillation. These defibrillators often caused electric shock injuries and deaths. Therefore, currently, except for internal defibrillation (ventricular fibrillation) using AC during cardiac surgery, direct current (DC) defibrillation is generally used. A sufficiently large current is output from the defibrillator and flows through the high-voltage wires of the defibrillator cable to the defibrillator electrodes. The current flows through the heart to stimulate the myocardium, causing all myocardial cells to depolarize simultaneously and enter a refractory period. This prompts the fibrillating myocardium to return to a synchronized contraction state, restoring normal heart function. This method is used for various patients requiring immediate defibrillation. One end of the cable connects to the defibrillator electrodes, and the other end connects to the defibrillator via a connector.

[0004] Conventional defibrillator cables, with two high-voltage wires and all signal lines in one unit, have the following problems: (1) The cable needs to be made into a spring-shaped coil with a telescopic function for storage, making it impossible to perform all-round cleaning, disinfection and sterilization treatment, which is not suitable for open-chest defibrillation operations; (2) With two high-voltage wires and all signal lines in one unit, when a large current is passed through during defibrillation operations, the two high-voltage wires are prone to mutual inductance, resulting in breakdown and creepage, which poses a significant safety hazard to medical staff and patients. Summary of the Invention

[0005] In view of the aforementioned problems, this application is made to provide an in-vivo non-implantable defibrillation cable that overcomes or at least partially solves the aforementioned problems, comprising:

[0006] One embodiment of this application discloses an in-vivo non-implantable defibrillation cable, comprising two cable groups;

[0007] Each of the cable assemblies consists of, from the inside out, a core assembly, a wrapping tape, and a sheath;

[0008] The core assembly includes a high-voltage conductor, two signal lines, and several tensile filler wires.

[0009] The tensile filler wire is filled inside the wrapping tape and disposed in the gap formed by the high-voltage conductor and the signal line.

[0010] Furthermore, the core assembly is a structure in which a high-voltage conductor, two signal lines, and several tensile filler wires are twisted together.

[0011] Furthermore, the two cable groups are connected side-by-side in parallel via a connector.

[0012] Furthermore, the connector has an easy-tear structure.

[0013] Furthermore, the strap is made of foamed polytetrafluoroethylene material.

[0014] Furthermore, the sheath is made of thermoplastic polyurethane elastomer material; its hardness is Shore 60 to 95A.

[0015] Furthermore, the center filament of the tensile filler wire is composed of para-aromatic polyamide fiber filament.

[0016] Furthermore, the high-voltage conductor includes a main conductor and a first insulation layer.

[0017] Furthermore, the first insulating layer is made of ethylene propylene rubber.

[0018] Furthermore, the signal line includes a signal core and a second insulating layer outside the signal core;

[0019] Alternatively; a shielding layer, the signal core, and a second insulating layer, wherein the second insulating layer isolates the shielding layer and the signal core.

[0020] This application has the following advantages: In the embodiments of this application, two cable groups are used; each cable group consists of a core group, a wrapping tape, and a sheath from the inside out; the core group includes a high-voltage conductor, two signal lines, and several tensile filler wires; wherein, the tensile filler wires are filled inside the wrapping tape and disposed in the gap formed by the high-voltage conductor and the signal lines. In use, one end of each of the two high-voltage conductors is connected to the defibrillator, and the other end is connected to the defibrillator electrode pads; one set of tensile filler wires, signal lines, and high-voltage conductors is combined with another set of tensile filler wires, signal lines, and high-voltage conductors in two different unit components to form a parallel double-parallel structure, which facilitates flexible operation of the two defibrillator electrode pads connected to the defibrillator cables by doctors, is suitable for internal defibrillation treatment of patients, and is also easier to clean and disinfect. The cable, which branches into two independent units connecting two defibrillation electrodes, allows doctors to adjust the electrodes arbitrarily according to the patient's lying position during operation, achieving flexible operability and ensuring efficient and safe defibrillation during surgery. In addition, the two independent unit components have the high-current, high-voltage wires independently encased inside their sheaths, further ensuring that the high-voltage wires will not break down or creep when high current is passed through during defibrillation, thus preventing short circuits and accidents. Attached Figure Description

[0021] To more clearly illustrate the technical solution of this application, the drawings used in the description of this application will be briefly introduced below. Obviously, the drawings described below are only some embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0022] Figure 1 This is a cross-sectional structural diagram of an in vivo non-implantable defibrillator cable provided in one embodiment of this application;

[0023] Figure 2 This is another cross-sectional structural diagram of an in vivo non-implantable defibrillator cable provided in one embodiment of this application;

[0024] Figure 3 This is a partially enlarged structural diagram of a connector in an in vivo non-implantable defibrillation cable provided in one embodiment of this application.

[0025] In the diagram, 1 is the high-voltage conductor; 2 is the signal wire; 3 is the tensile filler wire; 4 is the wrapping tape; 5 is the sheath; 11 is the main conductor; 12 is the first insulation layer; 21 is the signal conductor; 22 is the second insulation layer; and 23 is the shielding layer. Detailed Implementation

[0026] To make the objectives, features, and advantages of this application more apparent and understandable, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. Obviously, the described embodiments are only some, not all, of the embodiments of this application. All other embodiments obtained by those skilled in the art based on the embodiments of this application without inventive effort are within the scope of protection of this application.

[0027] It should be noted that the in-body non-implantable defibrillation cable, also known as the in-body defibrillation electrode connection cable, delivers a sufficiently large current from the defibrillator through the high-voltage wires of the cable to the defibrillation electrode pads. This current flows through the heart to stimulate the myocardium, causing all myocardial cells to depolarize simultaneously and enter a refractory period. This, in turn, promotes the return of the fibrillating myocardium to a synchronized contraction state, restoring normal heart function. It is used for various patients requiring immediate defibrillation. One end of the cable connects to the defibrillation electrode pads, and the other end connects to the defibrillator via a connector.

[0028] Defibrillation and cardioversion current: This involves converting alternating current into high-voltage direct current (4–7 kVd), storing it in a 16–32 μF capacitor, and discharging it to the heart within milliseconds, with a power output exceeding 300 joules. Due to the high voltage, the aforementioned technical problems of breakdown and creepage can easily occur, posing safety hazards.

[0029] Breakdown is a destructive discharge that occurs inside an insulator under the influence of an electric field, causing a decrease in insulation resistance, an increase in current, and damage and perforation.

[0030] Creepage is a slight electrical discharge phenomenon on the surface of an insulator between two electrodes, causing the surface of the insulator to appear as dendritic or leaf-like discharge marks. These discharge marks are generally not continuous between the two electrodes, and the discharge occurs only under specific conditions, such as humid weather, dirt or dust on the insulator surface, etc. Over time, this can lead to insulation damage. Factors affecting creepage include the length of the arc during creepage, the size of the contaminated area, air humidity, voltage level, and the insulation strength of the insulating material.

[0031] The following will further describe a high-lifespan ultrasonic electrosurgical wire in this exemplary embodiment.

[0032] Reference Figure 1 This application illustrates an embodiment of an in-vivo non-implantable defibrillator cable, comprising two cable groups; each cable group consists of a core group, a wrapping tape 4, and a sheath 5 from the inside out; the core group includes a high-voltage conductor 1, two signal lines 2, and a plurality of tensile filler lines 3; wherein the tensile filler lines 3 fill the gaps formed within the wrapping tape 4 and outside the high-voltage conductor 1 and the signal lines 2.

[0033] In use, one end of each of the two high-voltage leads 1 is connected to the defibrillator, and the other end is connected to the defibrillator electrode pads. One set of tensile filler wires 3, signal wires 2, and high-voltage leads 1 are combined with another set of tensile filler wires 3, signal wires 2, and high-voltage leads 1 in two different unit components, forming a parallel double-parallel structure. This allows doctors to flexibly operate the two defibrillator electrode pads connected to the defibrillator cables, making it suitable for internal defibrillation treatment of patients and easier to clean and disinfect. The two branch lines form independent units connecting the two defibrillator electrodes. During operation, doctors can adjust the defibrillator electrodes arbitrarily according to the patient's lying position, achieving flexible operability and ensuring efficient and safe defibrillation during surgery. Furthermore, the two independent unit components independently encase the high-current high-voltage lead 1 within its sheath 5, further ensuring that the high-voltage lead will not break down or creep during high-current defibrillation operations, thus preventing short circuits and accidents.

[0034] In one embodiment of this application, the aforementioned core assembly comprises a high-voltage conductor 1, two signal wires 2, and several tensile filler wires 3 twisted together. By adding tensile filler wires 3 to the cable, the cable as a whole possesses excellent tensile strength. Twisting the high-voltage conductor 1, the two signal wires 2, and the several tensile filler wires 3 together ensures, on the one hand, the roundness of each unit core in the twisted cable and the aesthetics of the finished product; on the other hand, it further enhances the tensile strength of the cable.

[0035] In one specific embodiment, the central filament of the tensile filler wire 3 is composed of para-aromatic polyamide fiber filament; specifically, the central filament of the tensile filler wire 3 is para-aromatic polyamide invented by DuPont, USA, which is a high-performance fiber filament (KEVLAR) with high tensile strength and high temperature resistance, which can increase the overall tensile strength of non-implantable defibrillator cables in the body.

[0036] In one embodiment of this application, as Figure 1-3 As shown, the two cable groups are connected side-by-side in parallel via connector 6; specifically, as... Figure 3As shown, the connector 6 is an easy-tear structure. Two independent wires are connected together via connector 6, arranging the two cable groups in parallel. The easy-tear connector 6 allows for manual tearing according to electrode processing requirements or doctor's operational needs, further facilitating flexible operation of the two defibrillation electrode pads connected to the defibrillation cables. The easy-tear connector 6 can be an easy-tear wire, or it can be formed by discontinuous adhesive application to the sheaths 5 of the two independent cable groups, making them a parallel, integrated structure. Discontinuous adhesive application makes the connection easy to tear. Alternatively, the easy-tear connector 6 can be formed by removing a portion of the connector 6 through a mold during cable extrusion, creating a discontinuous structure (i.e., the easy-tear structure) between the sheaths of the two independent cables. The easy-tear structure includes, but is not limited to, the two forms described above.

[0037] In one embodiment of this application, the aforementioned strap 4 is a strap made of foamed polytetrafluoroethylene (PTFE). PTFE, commonly known as "the king of plastics," is a high-molecular polymer polymerized from tetrafluoroethylene monomers. It is white, waxy, translucent, and exhibits excellent heat and cold resistance, allowing for long-term use at temperatures ranging from -180°C to 260°C.

[0038] In one embodiment of this application, the sheath 5 is made of thermoplastic polyurethane elastomer material; its hardness is Shore 60 to 95A.

[0039] The aforementioned thermoplastic polyurethane elastomer, also known as thermoplastic TPU elastomer, possesses excellent elasticity, superior physical properties, and various mechanical strengths. TPU not only boasts outstanding high tensile strength, high tear strength, toughness, and aging resistance, but is also a mature and environmentally friendly material. This application preferably uses a sheath with a Shore hardness (a standard for material hardness) of 60-95A, giving the implantable non-implantable defibrillator (NFD) excellent flexibility, anti-tangling properties, and resistance to chemical disinfection. It allows for easy bending, comfortable use, and easy cleaning.

[0040] In one embodiment of this application, the high-voltage conductor 1 includes a main conductor 11 and a first insulation layer 12. The first insulation layer 12 is preferably made of high-volume-resistivity ethylene propylene rubber extruded from a die; ethylene propylene rubber has excellent insulation properties, with a volume resistivity of 10¹³ to 10¹⁵ Ω*m, a breakdown voltage of 30–40 MV / m, and a dielectric constant (1 kHz, 20 °C) of 2.27. This application preferably uses, but is not limited to, the aforementioned ethylene propylene rubber material as the material for the first insulation layer 12.

[0041] In a preferred example, the main performance advantages of the first insulating layer 12 made of EPDM rubber are as follows: (1) High cost performance, low raw rubber density, only 0.86~0.90g / cm3, which is the lightest commonly used rubber; and it can be filled in large quantities to reduce the cost of rubber. (2) Excellent aging resistance, weather resistance, ozone resistance, sunlight resistance, heat resistance, water resistance, water vapor resistance, ultraviolet resistance, radiation resistance and other aging properties. (3) Excellent chemical resistance, resistant to acids, alkalis, detergents, animal and vegetable oils, alcohols, ketones, etc.; outstanding water resistance, hot water resistance, water vapor resistance; polar oil resistance. (4) Excellent insulation performance, volume resistivity of 10 to the power of 14 Ω*m, breakdown voltage of 30~40MV / m, dielectric constant (1kHz, 20℃) 2.27. (5) Wide applicable temperature range, minimum operating temperature of -40~-60℃, can be used for a long time at 130℃. These advantages ensure that the aforementioned high-voltage conductor 1 can be used stably for a long time, improving the overall safety, stability, and service life of the cable.

[0042] In one embodiment of this application, the signal line 1 includes a signal core 21 and a second insulation layer 22 outside the signal core 21; the second insulation layer 22 further isolates the signal core 21 from the main core 11 of the high-voltage conductor.

[0043] In one embodiment of this application, as Figure 2 As shown, the signal line 1 includes a shielding layer 23, a signal core 21, and a second insulating layer 22, wherein the second insulating layer 22 isolates the shielding layer 23 and the signal core 21. The shielding layer 23 prevents the signal in the signal line from being interfered with by the current in the voltage conductor 1 and shields against external electromagnetic interference; for example, the shielding layer 23 can be a braided conductor or a shielding film, thereby isolating the signal line from external signals and preventing signal interference. For example,... Figure 2 As shown, the second insulating layer 2 can also be a two-layer structure, wherein the shielding layer 23 is disposed between the two layers of the second insulating layer 2, and the second insulating layer 2 is preferably made of the same material as the first insulating layer 12.

[0044] The beneficial effects of this application include that by grouping the two high-current high-voltage conductors 1 and the four signal lines 2 in the cable into two independent sheaths 5 connected by connectors 6, it can effectively ensure that when the defibrillator is used, the high current passing through the high-voltage conductors 1 avoids high-voltage line breakdown, short circuit or creepage, which can greatly avoid accidents. In addition, the parallel straight cable is more suitable for cleaning and disinfection.

[0045] This application groups the two high-current high-voltage conductors 1 and four signal lines 2 in the cable and lays them separately in two independent sheaths 5 connected by connectors 6. This allows doctors to flexibly operate the electrodes and cables by tearing open the connectors as needed according to the patient's body shape when operating the two defibrillation electrodes.

[0046] This application groups the two high-current high-voltage conductors 1 and four signal lines 2 in the cable and lays them separately in two independent sheaths 5 connected by connectors 6, so that the finished cable forms a parallel double structure. Except for the cables at the end of the operating electrode plates being partially separated, most of the cables are still connected together by the middle connectors 6 of the sheaths 5, and it is still a whole cable. The cable length can be longer, which can prevent defibrillators that cannot be completely sterilized from getting close to patients in open-chest surgery, thus avoiding infection.

[0047] The various embodiments in this specification are described in a progressive manner, with each embodiment focusing on the differences from other embodiments. The same or similar parts between the various embodiments can be referred to each other.

[0048] Although preferred embodiments of the present application have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments as well as all changes and modifications falling within the scope of the embodiments of the present application.

[0049] Finally, it should be noted that in this document, relational terms such as "first" and "second" are used only to distinguish one entity or operation from another, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Furthermore, the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or terminal device. Without further limitations, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or terminal device that includes said element.

[0050] The above provides a detailed description of an in-vivo non-implantable defibrillator cable provided in this application. Specific examples have been used to illustrate the principles and implementation methods of this application. The descriptions of the above embodiments are only for the purpose of helping to understand the method and core ideas of this application. At the same time, for those skilled in the art, there will be changes in the specific implementation methods and application scope based on the ideas of this application. Therefore, the content of this specification should not be construed as a limitation of this application.

Claims

1. An in-vivo non-implantable defibrillation cable, characterized in that, Includes two cable sets; Each of the cable assemblies consists of, from the inside out, a core assembly, a wrapping tape, and a sheath; The core assembly includes a high-voltage conductor, two signal lines, and several tensile filler wires. The tensile filler wire is filled inside the wrapping tape and disposed in the gap formed by the high-voltage conductor and the signal line. The two cable groups are connected side-by-side in parallel by a connector; the connector has an easy-tear structure.

2. The in-vivo non-implantable defibrillation cable according to claim 1, characterized in that, The core assembly consists of a high-voltage conductor, two signal lines, and several tensile filler wires twisted together.

3. The in-vivo non-implantable defibrillation cable according to claim 1, characterized in that, The strap is made of expanded polytetrafluoroethylene (PTFE) material.

4. The non-implantable defibrillation cable according to claim 1, characterized in that, The sheath is made of thermoplastic polyurethane elastomer material; its hardness is Shore 60 to 95A.

5. The in-vivo non-implantable defibrillation cable according to claim 1, characterized in that, The tensile filler center filament is composed of para-aromatic polyamide fiber filament.

6. The in-vivo non-implantable defibrillation cable according to claim 1, characterized in that, The high-voltage conductor includes a main conductor and a first insulation layer.

7. The in-vivo non-implantable defibrillation cable according to claim 6, characterized in that, The first insulating layer is made of ethylene propylene rubber.

8. The in-vivo non-implantable defibrillation cable according to claim 1, characterized in that, The signal line includes a signal core and a second insulating layer outside the signal core; Alternatively; a shielding layer, the signal core, and a second insulating layer, wherein the second insulating layer isolates the shielding layer and the signal core.

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