Medical degradable blood oxygen monitoring lead cable and manufacturing method thereof

Abstract

The embodiment of the invention provides a medical degradable blood oxygen monitoring lead cable and a manufacturing method thereof, and relates to the field of medical cables. Comprising a plurality of signal conductors which are mutually twisted; the inner shielding layer is formed by weaving a plurality of tinned copper wires along a first direction and wraps the signal core wires; the inner sheath layer wraps the inner shielding layer and is made of a first degradable material. The power supply core wire comprises a plurality of power supply conductors twisted outside the inner sheath layer; the outer shielding layer is formed by weaving a plurality of tinned copper wires along a second direction and wraps the power supply core wires; wherein the second direction is opposite to the first direction; the outer shielding layer is coated with the outer sheath layer, and the outer sheath layer is made of a second degradable material; wherein the degradation rate of the first degradable material is smaller than that of the second degradable material. The mechanical performance of the cable can be improved, environmental pollution is avoided, signal crosstalk is reduced, and the signal transmission stability is improved.

Description

Technical Field

[0001] The present invention relates to the field of medical cables, and in particular to a medical degradable blood oxygen monitoring lead cable and a manufacturing method thereof. Background Art

[0002] Currently, blood oxygen monitoring lead wires generally use PVC, silicone, or non-degradable polymer materials as insulation and sheaths. These materials have the following problems:

[0003] Poor biocompatibility: Long-term contact with the human body may trigger an inflammatory response, and non-degradable materials increase the risk of infection. Environmental pollution: Discarded cables are difficult to recycle, contributing to medical waste pollution. Inadequate mechanical properties: Traditional materials are prone to aging and hardening, and are prone to breakage after repeated bending, shortening the lifespan of the device.

[0004] However, the shielding structure of existing degradable solutions conflicts with signal transmission. For example, liquid metal is embedded in a polymer matrix, the conductivity is unstable, and there is a lack of multi-layer twisted design, which leads to signal crosstalk with a typical value of >-70dB. Summary of the Invention

[0005] In view of the above problems, embodiments of the present invention are proposed to provide a medical degradable blood oxygen monitoring lead cable and a manufacturing method thereof that overcome the above problems or at least partially solve the above problems.

[0006] A medical degradable blood oxygen monitoring lead cable comprises a signal core wire, an inner shielding layer, an inner sheath layer, a power core wire, an outer shielding layer and an outer sheath layer, which are arranged in sequence from the inside to the outside;

[0007] The signal core wire includes a plurality of signal conductors twisted together;

[0008] The inner shielding layer is formed by weaving a plurality of tinned copper wires along a first direction and covering the outside of the signal core wire;

[0009] The inner sheath layer is coated on the outside of the inner shielding layer and is made of a first degradable material;

[0010] The power core wire comprises a plurality of power conductors twisted outside the inner sheath layer;

[0011] The outer shielding layer is composed of a plurality of tinned copper wires woven along the second direction and wrapped around the outside of the power core wire; wherein the second direction is opposite to the first direction;

[0012] The outer sheath layer is coated on the outside of the outer shielding layer and is made of a second degradable material; wherein the degradation rate of the first degradable material is lower than the degradation rate of the second degradable material.

[0013] Preferably, the first degradable material comprises a blend of polylactic acid and polybutylene adipate / terephthalate; and the second degradable material comprises a blend of polyglycolide and polycaprolactone.

[0014] Preferably, the difference in degradation rate between the first degradable material and the second degradable material is 15%-20%.

[0015] Preferably, the first degradable material comprises, by mass fraction, 70% polylactic acid, 25% polybutylene adipate / terephthalate, and 5% citrate plasticizer;

[0016] The second degradable material comprises, by mass fraction, 55% of polyglycolide, 40% of polycaprolactone and 5% of nano-hydroxyapatite.

[0017] Preferably, the signal core wire comprises two right-hand-twisted signal conductors, wherein the lay pitch is 8±0.5 mm and the lay angle is 35°;

[0018] The power core wire includes two power conductors twisted in the right direction outside the inner sheath layer, wherein the twist pitch is 24±1 mm and the twist angle is 18°.

[0019] Preferably, the signal conductor includes 25 0.05 mm tinned copper wires; the power conductor includes 10 0.08 mm bare copper wires.

[0020] Preferably, the inner shielding layer comprises 42 0.08 mm tinned copper wires braided in right direction; the outer shielding layer comprises 80 0.08 mm tinned copper wires braided in left direction.

[0021] Preferably, the shielding rates of the inner shielding layer and the outer shielding layer are ≥85%.

[0022] Preferably, the outer diameter of the inner sheath is 1.8 mm; the outer diameter of the outer sheath is 3.3 mm.

[0023] A method for manufacturing the above-mentioned cable comprises the following steps:

[0024] The steps are as follows:

[0025] Twisting multiple signal conductors to obtain a signal core wire;

[0026] Wrapping the signal core wire with a plurality of tinned copper wire braided layers braided along a first direction to obtain an inner shielding layer;

[0027] Using a first degradable material to cover the outside of the inner shielding layer to form an inner sheath;

[0028] Twisting a plurality of power conductors with the outer sheath, and covering the outer portion of the twisted conductors with a plurality of tinned copper wire braids braided in a second direction to obtain an outer shielding layer; wherein the second direction is opposite to the first direction;

[0029] A second degradable material is used to cover the outer shielding layer to form an outer sheath.

[0030] This application specifically includes the following advantages:

[0031] In an embodiment of the present application, a signal core wire, an inner shielding layer, an inner sheath layer, a power core wire, an outer shielding layer and an outer sheath layer are arranged in sequence from the inside to the outside; the signal core wire includes a plurality of signal conductors twisted together; the inner shielding layer is woven by a plurality of tinned copper wires along a first direction and coated on the outside of the signal core wire; the inner sheath layer is coated on the outside of the inner shielding layer and adopts a first degradable material; the power core wire includes a plurality of power conductors twisted on the outside of the inner sheath layer; the outer shielding layer is woven by a plurality of tinned copper wires along a second direction and coated on the outside of the power core wire; wherein, the second direction is opposite to the first direction; the outer sheath layer is coated on the outside of the outer shielding layer and adopts a second degradable material; wherein, the degradation rate of the first degradable material is less than the degradation rate of the second degradable material. By designing a multi-layer twisted structure of signal core wires, inner and outer shielding layers, power core wires, and inner and outer sheath layers, and combining them with degradable materials, the cable can achieve both mechanical strength and signal fidelity. By using different degradable materials for the inner and outer sheath layers, and the degradation rate of the outer sheath being greater than that of the inner sheath, a gradient degradation is formed, which can avoid environmental pollution, improve biocompatibility and mechanical properties, and effectively protect the internal signal core wires. The reverse twisting of the inner and outer shielding layers can balance electromagnetic shielding effectiveness and degradation compatibility. This application can improve the mechanical properties of the cable, avoid environmental pollution, reduce signal crosstalk, and improve signal transmission stability. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the technical solution of the present application, the following is a brief introduction to the drawings required for the description of the present application. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0033] Figure 1 This is a schematic structural diagram of the medical degradable blood oxygen monitoring lead cable of the present invention;

[0034] Figure numerals: 1, signal core wire; 2, inner shielding layer; 3, inner sheath layer; 4, power core wire; 5, outer shielding layer; 6, outer sheath layer; 7, cotton yarn. DETAILED DESCRIPTION

[0035] To make the objectives, features, and advantages of this application more readily apparent, the present application is further described below in conjunction with the accompanying drawings and specific embodiments. It is apparent that the embodiments described are only a portion of the embodiments of this application, not all of them. All other embodiments derived by persons of ordinary skill in the art based on the embodiments in this application without inventive effort are also within the scope of protection of this application.

[0036] Reference Figure 1 , showing a schematic structural diagram of a medical degradable blood oxygen monitoring lead cable of the present invention, which may specifically include the following structure: a signal core wire 1, an inner shielding layer 2, an inner sheath layer 3, a power core wire 4, an outer shielding layer 5, and an outer sheath layer 6 arranged in sequence from the inside to the outside;

[0037] The signal core line 1 includes a plurality of signal conductors twisted together;

[0038] The inner shielding layer 2 is made of a plurality of tinned copper wires woven along a first direction and wrapped around the outside of the signal core wire 1;

[0039] The inner sheath layer 3 is coated on the outside of the inner shielding layer and is made of a first degradable material;

[0040] The power core wire 4 includes a plurality of power conductors twisted outside the inner sheath layer 3;

[0041] The outer shielding layer 5 is made of a plurality of tinned copper wires woven along the second direction and wrapped around the outside of the power core wire 4; wherein the second direction is opposite to the first direction;

[0042] The outer sheath layer 6 is coated on the outside of the outer shielding layer 5 and is made of a second degradable material; wherein the degradation rate of the first degradable material is lower than the degradation rate of the second degradable material.

[0043] In an embodiment of the present application, a signal core wire 1, an inner shielding layer 2, an inner sheath layer 3, a power core wire 4, an outer shielding layer 5 and an outer sheath layer 6 are arranged in sequence from the inside to the outside; the signal core wire 1 includes a plurality of signal conductors twisted together; the inner shielding layer 2 is woven by a plurality of tinned copper wires along a first direction and coated on the outside of the signal core wire 1; the inner sheath layer 3 is coated on the outside of the inner shielding layer and adopts a first degradable material; the power core wire 4 includes a plurality of power conductors twisted on the outside of the inner sheath layer 3; the outer shielding layer 5 is woven by a plurality of tinned copper wires along a second direction and coated on the outside of the power core wire 4; wherein, the second direction is opposite to the first direction; the outer sheath layer 6 is coated on the outside of the outer shielding layer 5 and adopts a second degradable material; wherein, the degradation rate of the first degradable material is less than the degradation rate of the second degradable material. By designing a multi-layer twisted structure comprising a signal core 1, inner and outer shielding layers 5, a power core 4, and inner and outer sheath layers 6, and combining them with degradable materials, the cable achieves both mechanical strength and signal fidelity. By using different degradable materials for the inner and outer sheath layers 3 and 6, respectively, and with the outer sheath degrading at a faster rate than the inner sheath, a gradient degradation is formed, which can avoid environmental pollution, improve biocompatibility and mechanical properties, and effectively protect the internal signal core 1. Furthermore, by reverse twisting the inner and outer shielding layers 5, a balance can be achieved between electromagnetic shielding effectiveness and degradation compatibility. This application can improve the mechanical properties of the cable, avoid environmental pollution, reduce signal crosstalk, and enhance signal transmission stability.

[0044] Next, a medical degradable blood oxygen monitoring lead cable in this exemplary embodiment will be further described.

[0045] In an embodiment of the present application, the above-mentioned lead cable is composed of a four-layer twisted structure, and its signal core wire 1 includes a plurality of mutually twisted signal conductors for stable signal transmission. The signal core wire 1 is externally coated with a tinned copper wire braided layer woven in a specific direction, which serves as the first shielding layer of the signal core wire 1 and can shield external or outer electromagnetic interference and signal crosstalk. The inner sheath is coated on the outside of the inner shielding layer 2. The inner sheath adopts a first degradable material to insulate and protect the signal core wire 1 and the inner shielding layer 2, and can be degraded. The power core wire 4 is composed of a plurality of power conductors twisted on the outside of the inner sheath. It has a high shielding performance with the signal core wire 1 and can reduce signal crosstalk. When twisting, cotton yarn 7 can be filled in the twisted gap to avoid the gap being too large. The power core wire 4 is coated with a tinned copper wire braided layer woven in another direction, which is opposite to the direction of the inner shielding layer 2, so that the electromagnetic shielding effectiveness can be balanced. The outer shielding layer 5 is covered with an outer sheath, adopting a double-layer sheath structure, which can improve the overall protection performance and flexibility of the cable. The outer sheath is made of a degradable material and is degradable without causing environmental pollution. The first degradable material of the inner sheath is different from the second degradable material of the outer sheath. The degradation rate of the first degradable material is slower than that of the second degradable material, resulting in a gradient degradation between the inner and outer sheaths. The degradation rate of the inner sheath is slower than that of the outer sheath, which can meet the requirements of the cable life cycle. During the service life, the inner layer degrades slowly to maintain mechanical strength and protect the internal signal core 1 and inner shielding layer 2. During the retirement period, the outer layer degrades rapidly, exposing the inner layer and initiating its degradation, avoiding long-term residue.

[0046] As an example, the first degradable material includes a blend of polylactic acid (PLA) and polybutylene adipate / terephthalate (PBAT).

[0047] Specifically, the first degradable material comprises, by mass, 70% polylactic acid, 25% polybutylene adipate / terephthalate, and 5% citrate plasticizer.

[0048] The inner sheath is primarily made of PLA, a material known for its excellent biodegradability, and is doped with 25% PBAT, which compensates for PLA's deficiencies in toughness and elongation at break. This balances rigidity and flexibility, maintaining biodegradability while maintaining a certain strength and hardness, resulting in optimal mechanical properties and a balance between mechanical strength and biodegradability. Furthermore, the addition of 5% citrate plasticizer enhances the interfacial stability of the inner and outer layers.

[0049] As an example, the second degradable material includes a blend of polyglycolide (PGA) and polycaprolactone (PCL).

[0050] Specifically, the second degradable material comprises, by mass, 55% polyglycolide, 40% polycaprolactone and 5% nano-hydroxyapatite.

[0051] The outer sheath uses PGA as the primary degradation material, which exhibits a high degradation rate, high tensile strength, and low impact resistance. By doping with 40% PCL, the degradation rate of the outer sheath can be regulated, significantly improving the toughness, ductility, and impact resistance of the blend, making it less prone to brittle fracture. Furthermore, as an outer sheath, it possesses high impact resistance. Furthermore, both PGA and PCL have good biocompatibility. Blending them in appropriate proportions can adjust the hydrophilicity and hydrophobicity of the material, thereby regulating its biocompatibility and optimizing its various performance characteristics. Furthermore, by doping with 5% nanohydroxyapatite, the interfacial compatibility between PGA and PCL can be improved, while also enhancing the bioactivity of the outer sheath.

[0052] Through the above-mentioned material and proportion design, a gradient degradation is formed between the inner and outer sheaths, and the cable can be guaranteed to have excellent mechanical strength and biocompatibility; at the same time, the degradation rate difference between the inner and outer sheaths is maintained at 15%-20%, matching the clinical use cycle of the blood oxygen monitoring lead cable.

[0053] As an example, the signal core wire 1 includes two green-white right-twisted signal conductors, wherein the lay pitch is 8±0.5 mm and the lay angle is 35°. The signal conductors include 25 0.05 mm tinned copper wires.

[0054] As an example, the power core wire 4 includes two red and black power conductors twisted in the right direction outside the inner sheath layer 3, wherein the lay pitch is 24±1mm and the lay angle is 18°. The power conductors include 10 0.08mm bare copper wires.

[0055] As an example, the inner shielding layer 2 includes 42 0.08mm tinned copper wires woven in the right direction; the outer shielding layer 5 includes 80 0.08mm tinned copper wires woven in the left direction. And the shielding rate of the inner shielding layer 2 and the outer shielding layer 5 is ≥85%. The double-layer shielding structure has higher shielding performance. At the same time, the reverse twisting of the inner and outer shields can eliminate the window effect and prevent electromagnetic interference from leaking from the braided mesh when the cable is bent. The stacked structure with opposite braiding directions helps to balance the stress of the cable, making the cable less likely to kink when bent and maintain flexibility. The difference in the number of roots in the inner layer (42) and the outer layer (80) makes the outer shielding denser and better resistant to external wear and pressure injuries; at the same time, it optimizes low-frequency shielding, balances shielding effectiveness, achieves excellent electromagnetic shielding compatibility, and ensures the stability of internal signal transmission.

[0056] As an example, the outer diameter of the inner sheath is 1.8 mm; the outer diameter of the outer sheath is 3.3 mm, which enables the cable to maintain a smaller outer diameter and have the characteristics of being thinner, thinner and more flexible.

[0057] The present application also provides a method for manufacturing a medical degradable blood oxygen monitoring lead cable, comprising the following steps:

[0058] A plurality of signal conductors are twisted together to obtain a signal core wire 1; a plurality of tinned copper wire braided layers woven along a first direction are coated on the outside of the signal core wire 1 to obtain an inner shielding layer 2; a first degradable material is used to coat the outside of the inner shielding layer 2 to form an inner sheath; a plurality of power supply conductors and the outer sheath are twisted together, and a plurality of tinned copper wire braided layers woven along a second direction are coated on the outside of the twisted layer to obtain an outer shielding layer 5; wherein the second direction is opposite to the first direction; a second degradable material is used to coat the outside of the outer shielding layer 5 to form an outer sheath.

[0059] In one embodiment, two green and white signal conductors are twisted in the right direction with a lay pitch of 8 mm and a twist angle of 35°, and are covered with a right-hand braided shield layer of 42 0.08 mm tinned copper wires. Then, a PLA / PBAT blend inner sheath is coated on the outside to control the outer diameter to 1.8 mm. Two power conductors (red and black) and cotton yarn 7 are twisted in the right direction with a lay pitch of 24 mm and a twist angle of 18° with an inner sheath coated with a left-hand braided shield of 80 0.08 mm copper wires. An outer sheath of PGA / PCL composite material is coated on the outside of the outer shield layer 5 to form a final outer diameter of 3.3 mm.

[0060] The cable was prepared according to the above structure and method, and the performance test results were as follows:

[0061] The degradation cycle can be controlled within 12-24 months (in vitro environment).

[0062] Bending life> 50,000 times (ASTM D790 standard).

[0063] Signal crosstalk <-90dB (100kHz test frequency).

[0064] Volume resistivity>1×10 14 Ω·cm.

[0065] Electromagnetic shielding effectiveness ≥30dB.

[0066] The test results above demonstrate that the combination of the biodegradable material and the multi-layer twisted structure in this application balances mechanical strength (bending life > 50,000 cycles) with signal fidelity (crosstalk < -90dB). The gradient degradation is compatible with electromagnetic shielding, maintaining stable signal transmission and the cable's mechanical properties.

[0067] Although the preferred embodiments of the present invention have been described, those skilled in the art may make additional changes and modifications to these embodiments once they become aware of the basic creative concepts. Therefore, the appended claims are intended to be interpreted as including the preferred embodiments and all changes and modifications that fall within the scope of the embodiments of the present invention.

[0068] Finally, it should be noted that, in this document, relational terms such as first and second, etc., are used only to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any actual relationship or order between these entities or operations. Moreover, the terms "comprises," "comprising," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or terminal device that includes a series of elements includes not only those elements, but also other elements not explicitly listed, or elements inherent to such process, method, article, or terminal device. In the absence of further limitations, an element defined by the phrase "comprising a ..." does not exclude the presence of additional identical elements in the process, method, article, or terminal device that includes the element.

[0069] The above is a detailed introduction to a medical degradable blood oxygen monitoring lead cable and a manufacturing method thereof provided by the present invention. Specific examples are used herein to illustrate the principles and implementation methods of the present invention. The description of the above embodiments is only used to help understand the method of the present invention and its core idea. At the same time, for those skilled in the art, according to the ideas of the present invention, there may be changes in the specific implementation methods and application scopes. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A medical degradable blood oxygen monitoring lead cable, characterized in that: It includes a signal core wire, an inner shielding layer, an inner sheath layer, a power core wire, an outer shielding layer and an outer sheath layer arranged in sequence from the inside to the outside; The signal core wire includes a plurality of signal conductors twisted together; The inner shielding layer is formed by weaving a plurality of tinned copper wires along a first direction and covering the outside of the signal core wire; The inner sheath layer is coated on the outside of the inner shielding layer and is made of a first degradable material; The power core wire comprises a plurality of power conductors twisted outside the inner sheath layer; The outer shielding layer is composed of a plurality of tinned copper wires woven along the second direction and wrapped around the outside of the power core wire; wherein the second direction is opposite to the first direction; The outer sheath layer is coated on the outside of the outer shielding layer and is made of a second degradable material; wherein the degradation rate of the first degradable material is lower than the degradation rate of the second degradable material.

2. The medical degradable blood oxygen monitoring lead cable according to claim 1, characterized in that: The first degradable material includes a blend of polylactic acid and polybutylene adipate / terephthalate; and the second degradable material includes a blend of polyglycolide and polycaprolactone.

3. The medical degradable blood oxygen monitoring lead cable according to claim 2, characterized in that: The difference in degradation rate between the first degradable material and the second degradable material is 15%-20%.

4. The medical degradable blood oxygen monitoring lead cable according to claim 3, characterized in that: The first degradable material comprises, by mass, 70% polylactic acid, 25% polybutylene adipate / terephthalate, and 5% citrate plasticizer; The second degradable material comprises, by mass fraction, 55% of polyglycolide, 40% of polycaprolactone and 5% of nano-hydroxyapatite.

5. The medical degradable blood oxygen monitoring lead cable according to claim 1, characterized in that: The signal core wire comprises two right-hand-twisted signal conductors, wherein the lay pitch is 8±0.5 mm and the lay angle is 35°; The power core wire includes two power conductors twisted in the right direction outside the inner sheath layer, wherein the twist pitch is 24±1 mm and the twist angle is 18°.

6. The medical degradable blood oxygen monitoring lead cable according to claim 5, characterized in that: The signal conductor includes 25 0.05mm tinned copper wires; the power conductor includes 10 0.08mm bare copper wires.

7. The medical degradable blood oxygen monitoring lead cable according to claim 5, characterized in that: The inner shielding layer includes 42 0.08 mm tinned copper wires braided in a right direction; the outer shielding layer includes 80 0.08 mm tinned copper wires braided in a left direction.

8. The medical degradable blood oxygen monitoring lead cable according to claim 7, characterized in that: The shielding rates of the inner shielding layer and the outer shielding layer are ≥85%.

9. The medical degradable blood oxygen monitoring lead cable according to claim 1, characterized in that: The outer diameter of the inner sheath is 1.8 mm; the outer diameter of the outer sheath is 3.3 mm.

10. A method for manufacturing a cable according to any one of claims 1 to 9, characterized in that: The steps include: Twisting multiple signal conductors to obtain a signal core wire; Wrapping the signal core wire with a plurality of tinned copper wire braided layers braided along a first direction to obtain an inner shielding layer; Using a first degradable material to cover the outside of the inner shielding layer to form an inner sheath; Twisting a plurality of power conductors with the outer sheath, and covering the outer portion of the twisted conductors with a plurality of tinned copper wire braids braided in a second direction to obtain an outer shielding layer; wherein the second direction is opposite to the first direction; A second degradable material is used to cover the outer shielding layer to form an outer sheath.

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