A method for manufacturing a micro medical heating component in batch production and the heating component

Abstract

This invention discloses a method for manufacturing a mass-producible miniature medical heating component and the heating component itself, applicable to ablation therapy or tissue anastomosis in minimally invasive surgical procedures. The manufacturing method includes the following steps: etching or laser-cutting a specific pattern of heating wires in an array on a heating substrate; bonding a thermally conductive substrate and an insulating substrate to the upper and lower surfaces of the heating wires respectively using high-temperature resistant adhesive; drilling holes at predetermined positions on the insulating substrate and injecting copper into the holes to form conductive channels; cutting the semi-finished substrate according to a specified shape; and obtaining the miniature medical heating component. This invention arranges the miniature medical heating components in an array to achieve mass production and ensures the consistency of the component's size, structure, and performance. This manufacturing method allows for mechanized mass production, effectively reducing manufacturing costs. It solves the problems of complex structure, high processing costs, and long processing time associated with existing medical heating components, and has broad application prospects.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a method for manufacturing a mass-producible miniature medical heating component and the heating component itself, applicable to ablation therapy and tissue anastomosis procedures in minimally invasive surgery. Background Technology

[0002] Ablation therapy is a surgical procedure in which doctors apply heat to destroy abnormal tissue that may be present in many medical conditions. For example, doctors may use ablation to destroy a small piece of heart tissue that causes an irregular heartbeat, or to treat tumors in the lungs, breast, thyroid, liver, or other parts of the body. Anastomosis means connecting two severed ends to form a continuous physiological structure. Examples include vascular anastomosis, gastrointestinal anastomosis, fallopian tube anastomosis, choledochoenterostomy, and nerve anastomosis. By using a heating device and applying pressure, specific tissues can be anastomosed; in minimally invasive surgical procedures, heating components are used to provide heat to ablate abnormal tissue or to complete tissue anastomosis through heating.

[0003] The design and manufacture of existing heating components for ablation therapy face the following challenges: 1. High requirements for heating component size: In interventional surgery, the operating space is limited, and medical devices must pass through narrow instrument channels or body cavities to reach the treatment site. Therefore, there are strict requirements for the size of each component, and heating components need to be miniaturized; 2. High requirements for the selection and assembly of heating components: The components need to realize functions such as heating and heat conduction, which places high demands on the heat resistance and thermal conductivity of the materials; Under the constraints of size and material selection, the heating components must successfully realize the functions of heating, heat conduction, and temperature feedback. Under the current technology, this often leads to problems such as complex structural design and high processing and assembly costs.

[0004] Therefore, there is a need for a compact, easy-to-manufacture, and highly efficient thermal conduction and precise temperature control micro-medical heating component to meet the industry's urgent needs. Summary of the Invention

[0005] The purpose of this invention is to provide a miniaturized, low-cost medical heating component; this purpose is achieved through the following technical solution:

[0006] This invention provides a method for manufacturing a miniature medical heating component that can be mass-produced, comprising the following steps:

[0007] S1, etching or laser cutting a specific pattern of heating wires arranged in an array on the heating substrate;

[0008] S2, the heat-conducting substrate and the insulating substrate are respectively bonded to the upper and lower surfaces of the heating wire processed in S1 using high-temperature resistant adhesive;

[0009] S3, Drill holes at predetermined positions on the insulating substrate and inject copper into the holes to form conductive channels;

[0010] S4, the semi-finished product in S3 is mechanically or laser-cut according to the specified shape to obtain the miniature medical heating component.

[0011] Preferably, between steps S3 and S4, step S31 is further included: attaching a temperature sensor at a predetermined position on the insulating substrate, wherein the temperature sensor is any one of a K-type thermocouple, a T-type thermocouple, or a thermistor.

[0012] Furthermore, the heating substrate material is a nickel-chromium alloy or an iron-chromium-aluminum alloy.

[0013] In a second aspect, the present invention provides a method for manufacturing a miniature medical heating component, comprising the following steps:

[0014] S1: The resistive paste is screen-printed onto a thermally conductive substrate to form a specific pattern of array arrangement, and then sintered and solidified into a heating wire;

[0015] S2: In S1, the thermistor material is printed onto the surface of the thermally conductive substrate and then sintered and cured to form a temperature sensor. The heating wire and the temperature sensor are located on the same side of the thermally conductive substrate.

[0016] S3: The side of the thermally conductive substrate with the heating wire and temperature sensor described in S2 is bonded to the insulating substrate with high-temperature resistant adhesive.

[0017] S4: Drill holes at predetermined positions on the insulating substrate described in S3, and inject copper into the holes to form conductive channels;

[0018] S5: The semi-finished product in S4 is mechanically or laser-cut according to the specified shape to obtain the miniature medical heating component.

[0019] Preferably, the resistive paste is ruthenium paste.

[0020] Furthermore, the thermally conductive substrate is a ceramic material or a metal material, wherein the ceramic material is any one of aluminum nitride, boron nitride, or silicon carbide; and the metal material is an aluminum alloy.

[0021] Preferably, the specific pattern is any one of linear, circular, and spiral shapes, and the resistance of the heating wire is in the range of 0.5Ω to 10Ω, with a heating power of 5W to 50W.

[0022] Furthermore, the thickness of the heating wire is between 50 and 100 micrometers, the thickness of the thermally conductive substrate is between 200 and 500 micrometers, the thickness of the insulating substrate is between 25 and 125 micrometers, and the overall thickness of the heating component is between 0.4 and 1.0 mm.

[0023] Preferably, the heating substrate and / or the thermally conductive substrate are coated with a biocompatible insulating coating, which is a pyrene coating or a polytetrafluoroethylene coating.

[0024] Furthermore, the high-temperature resistant adhesive is a thermosetting acrylic adhesive or an epoxy resin thermosetting adhesive; the bonding process involves pressing the heating layer, the heat-conducting layer, and the lead wire layer together at a high temperature; the thickness of the adhesive after bonding is between 12 and 50 micrometers.

[0025] In a third aspect, the present invention provides a mass-producible miniature medical heating component, comprising:

[0026] The thermally conductive layer, including the thermally conductive substrate, has a thickness between 200 and 500 micrometers.

[0027] The heating layer includes a heating wire fixed to the thermally conductive substrate; the heating wire is in any one of the following shapes: linear, annular, and spiral; the thickness of the heating wire is 50 to 100 micrometers; the resistance of the heating wire is in the range of 0.5Ω to 10Ω; and the heating power is 5W to 50W.

[0028] The lead layer includes an insulating substrate and a conductive channel, the thickness of which is between 25 and 125 micrometers; the conductive channel includes a hole-like structure disposed on the insulating substrate, and the conductive channel is filled with a conductive material; the insulating substrate is connected to the heating layer by a high-temperature resistant adhesive, and the heat-conducting layer, the heating layer and the lead layer are arranged in layers;

[0029] A temperature sensor, which is integrated into the lead layer and / or heating layer.

[0030] Compared with the prior art, the beneficial effects that at least one technical solution adopted in the embodiments of this specification can achieve include at least:

[0031] First, the miniature medical heating component of the present invention is highly flexible and can be processed into various shapes, such as linear, ring, and spiral, by etching or screen printing according to the needs of different environments in the human body. It can be precisely adjusted for different surgical needs and is particularly suitable for ablation and anastomosis in minimally invasive surgery.

[0032] In ablation procedures, for areas requiring precise ablation (such as abnormal cardiac tissue or tumors), the shape and layout of the heating wire can be customized according to the size and shape of the treatment area. For example, ring or spiral heating wires can distribute heat more evenly, covering the entire treatment area, ensuring precise heat output during the ablation process, and reducing damage to surrounding healthy tissues.

[0033] In anastomotic procedures (such as vascular anastomosis and gastrointestinal anastomosis), linear or ring-shaped heating wires can be customized according to the shape of the tissue ends, ensuring a close fit between the heating element and the anastomosis site. Precise heat output promotes rapid tissue healing. Spiral heating wires provide a larger contact surface, effectively improving heat conduction efficiency, making the anastomosis process more reliable, and shortening surgical time.

[0034] Secondly, the present invention uses a layered bonding design of heating layer, heat conduction layer and lead wire layer to tightly combine functional components such as heating, heat conduction and temperature feedback; by controlling the thickness of each layer of the heating component, the thickness of the heating component can be reduced to less than 1mm, achieving the effect of integration and miniaturization.

[0035] In ablation procedures, surgical instruments must pass through narrow passages in the human body to reach specific treatment sites, such as the heart and blood vessels. By reducing the thickness of the heating element to less than 1 mm, this invention enables medical devices to pass more easily and flexibly through narrow catheters or endoscopes, reducing invasiveness during surgery. In addition, the miniaturized design of the components not only reduces pressure on healthy tissues but also allows for more precise focusing on abnormal tissues, enabling efficient ablation and reducing postoperative complications.

[0036] In anastomosis, the surgical site is often located in deep tissues of the body, such as blood vessels and the gastrointestinal tract. The ultra-thin design of the heating element allows it to fit perfectly into the anastomosis site without requiring excessive instrument space, achieving rapid and precise heat conduction and promoting tissue healing. Due to the extremely thin thickness of the heating element, it can make closer contact with the tissue, improving heat conduction efficiency, shortening the operation time, and reducing heat loss, ensuring a more stable and safer anastomosis process.

[0037] Third, the miniature medical heating components of the present invention can be mass-produced in one go. The present invention uses a whole aluminum nitride ceramic plate as a heat-conducting substrate and a whole polyimide film as an insulating substrate. Multiple tiny heating components can be made by bonding with high-temperature resistant adhesive and then laser cutting or other methods. This allows for mechanized mass production, thereby solving the problem of high processing and assembly costs. Attached Figure Description

[0038] To more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0039] Figure 1 This is a schematic diagram of the structure of the miniature medical heating component of the present invention;

[0040] Figure 2This is a schematic diagram of the heating wire of the present invention;

[0041] Figure 3a This is a schematic diagram of the heating wire structure according to the first preferred embodiment of the present invention;

[0042] Figure 3b This is a schematic diagram of the heating wire structure according to the second preferred embodiment of the present invention.

[0043] Figure 3c This is a schematic diagram of the heating wire structure according to the third preferred embodiment of the present invention;

[0044] Figure 4 A schematic diagram illustrating a preferred method for manufacturing the heating wire according to the present invention;

[0045] Figure 5 This is a schematic diagram of the cutting process for the miniature medical heating component of the present invention;

[0046] Figure 6 This is a cross-sectional view of a second embodiment of the miniature medical heating component of the present invention;

[0047] Figure 7 This is a schematic diagram of the screen-printed heating wire in the third embodiment of the present invention.

[0048] Explanation of reference numerals in the attached figures

[0049] 1. Thermal conductive layer; 2. Heating layer; 21. Heating wire; 3. Lead wire layer; 31. Conductive channel. Detailed Implementation

[0050] The embodiments of the present invention will now be described in detail with reference to the accompanying drawings.

[0051] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of the present invention, and not all of them. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that, in the absence of conflict, the following embodiments and features in the embodiments can be combined with each other. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.

[0052] It should be noted that various aspects of embodiments within the scope of the appended claims are described below. It will be apparent that the aspects described herein can be embodied in a wide variety of forms, and any particular structure and / or function described herein is merely illustrative. Based on this invention, those skilled in the art will understand that one aspect described herein can be implemented independently of any other aspect, and two or more of these aspects can be combined in various ways. For example, any number and aspects set forth herein can be used to implement the device and / or practice the method. Additionally, this device and / or method can be implemented using structures and / or functionalities other than one or more of the aspects set forth herein.

[0053] Example 1:

[0054] See Figure 1 This embodiment provides a miniature medical heating component. The component has a compact structure and integrates functions such as heating, heat conduction, and temperature feedback. It is suitable for various medical scenarios, such as vascular anastomosis and ablation therapy. The miniature medical heating component includes a heat-conducting layer 1, a heating layer 2, and a lead wire layer 3. The functional layers are bonded together with high-temperature resistant adhesive and fixed by pressing. The heat-conducting layer 1 includes a heat-conducting substrate, the heating layer 2 includes a heating wire 21 and high-temperature resistant adhesive, and the lead wire layer 3 includes an insulating substrate and a conductive channel 31.

[0055] In a preferred embodiment, such as Figure 2 The heating layer 2 shown includes a spiral heating wire 21 made of nickel-chromium alloy, which is fixed to the surface of the heat-conducting layer 1. Nickel-chromium alloy has a high resistivity, allowing electrical energy to be effectively converted into heat energy. Besides nickel-chromium alloy, the heating wire can also be made of iron-chromium-aluminum alloy, tungsten, or ruthenium oxide. The heating wire 21 has a resistance of 5Ω and a heating power of 20W, enabling it to reach the required treatment temperature in a short time. The thickness of the heating layer 2 is controlled at 75 micrometers to ensure it can adapt to the space constraints in minimally invasive surgery. Preferably, as... Figure 3a , Figure 3b and Figure 3c As shown, the heating wire 21 can also be linear or annular in shape.

[0056] In a preferred embodiment, the thermally conductive substrate uses aluminum nitride ceramic material, which has a thermal conductivity greater than 50 W / m·K, enabling it to rapidly conduct the heat generated by the heating layer 2 and distribute it evenly to the target tissue. However, it should be understood that using aluminum nitride ceramic material as the thermally conductive substrate is only a preferred option. In other embodiments, ceramic materials or metal materials can be used. The ceramic material is any one of aluminum nitride, boron nitride, or silicon carbide, and the metal material is an aluminum alloy. The thermally conductive layer 1 is firmly bonded to the heating layer 2 with a high-temperature resistant adhesive. The thickness of the adhesive is controlled within 25 micrometers to ensure heat conduction efficiency. The thickness of the thermally conductive layer 1 is 300 micrometers, which provides sufficient thermal conductivity while ensuring the miniaturization of the overall structure.

[0057] In a preferred embodiment, the lead layer 3 is made of a polyimide (PI) insulating substrate, on which conductive channels 31 are pre-drilled. Conductive paths are formed by drilling holes at preset positions and filling them with copper material. One end of the conductive channel 31 is connected to the heating layer 2, and the other end is connected to an external control system via a wire to provide a stable current. The lead layer 3 has a thickness of 50 micrometers to ensure its operational flexibility in minimally invasive surgery. The lead layer 3 also integrates a temperature sensor, which is adjacent to the heating layer 2 and is used to monitor the operating temperature of the heating layer 2 in real time and feed it back to the control system for temperature adjustment. Preferably, a temperature sensor can also be integrated on the thermally conductive layer 1.

[0058] In a preferred embodiment, to improve safety, the exterior of the thermally conductive substrate is covered with a parylene insulating coating. This coating not only provides good electrical insulation but also reduces the coefficient of friction on the surface of the heating element, facilitating the insertion and operation of the instrument in confined spaces. The coating thickness is 15 micrometers to ensure that it does not affect the overall size of the heating element. It should be understood that the use of a parylene insulating coating is only preferred, and any biocompatible coating material can be used as the insulating coating in this embodiment.

[0059] In a preferred embodiment, a temperature sensor is integrated into the heat-conducting layer 1 and connected to an external host via a wire, enabling precise monitoring of the operating temperature of the heating wire 21. When the temperature of the heating component reaches a preset value, the sensor sends a feedback signal to the external host, which adjusts the heating current based on the feedback signal to prevent overheating and ensure the safety and effectiveness of the treatment. Preferably, the temperature sensor can be a K-type thermocouple, a T-type thermocouple, or a thermistor. The temperature sensor can be directly integrated into the lead layer 3 or connected separately to the micro medical heating component.

[0060] In a preferred embodiment, the miniature medical heating element is manufactured by the following steps:

[0061] Step 1, as follows Figure 4As shown, a predetermined heating wire 21 shape is etched on the heating substrate; the heating substrate is preferably a nickel-chromium alloy plate, and multiple heating wires 21 of heating components can be processed simultaneously on a whole nickel-chromium alloy plate.

[0062] Step 2: The nickel-chromium alloy plate processed in Step 1 is bonded to the thermally conductive substrate with high-temperature resistant adhesive. Preferably, the thermally conductive substrate is an aluminum nitride ceramic plate.

[0063] Step 3: Print thermistor material at a predetermined position on the insulating substrate and sinter it to form a temperature sensor. Preferably, the insulating substrate is a polyimide film.

[0064] Step 4: Bond the heating wire 21 from step 2 and the insulating substrate from step 3 together with high-temperature resistant adhesive.

[0065] Step 5: Drill holes at predetermined positions on the insulating substrate, and inject copper or conductive carbon powder into the holes to form conductive channels 31.

[0066] Step 6, as follows Figure 5 As shown, the bonded semi-finished board is mechanically or laser-cut according to a specified shape to obtain the miniature medical heating component.

[0067] In a preferred embodiment, more than 48 miniature medical heating components can be manufactured simultaneously on a 100*100mm substrate. This manufacturing method reduces processing costs and processing time by more than 80% and 85% respectively, and the manufactured heating components have consistent dimensions, stable structure and performance.

[0068] Example 2:

[0069] like Figure 7 As shown, in this embodiment 2, based on embodiment 1, the number of conductive channels 31 is preferably two, and each conductive channel 31 is connected to a wire. The heating wire 21 and the temperature sensor are respectively connected to the wires of the two conductive channels 31.

[0070] Furthermore, such as Figure 1 and Figure 6 As shown, in this embodiment 2, based on embodiment 1, the number of conductive channels 31 is preferably 4, and the wire can be wound around multiple conductive channels 31 at the same time to achieve storage and fixation.

[0071] Example 3:

[0072] This embodiment 3 differs from embodiment 1 in that the miniature medical heating component is manufactured using the following steps:

[0073] Step 1: The heating layer 2 of the micro medical heating component is printed on a thermally conductive substrate in the form of resistive paste; preferably, the resistive paste used is ruthenium paste; preferably, the material of the thermally conductive substrate is aluminum nitride ceramic; multiple heating layers 2 of heating components can be printed simultaneously on one thermally conductive substrate; a schematic diagram of the processing of a single heating layer 2 is shown below. Figure 7 As shown, the resistive paste is used to form a specific pattern on the thermally conductive substrate through processes such as screen printing, and then sintered and cured to form the heating layer 2.

[0074] Step 2: Print the thermistor material onto the surface of the thermally conductive substrate, and then sinter and solidify it at high temperature to form a temperature sensor.

[0075] Step 3: Bond the thermally conductive substrate and the insulating substrate processed in Step 2 together with high-temperature resistant adhesive. Preferably, the insulating substrate is a polyimide film.

[0076] Step 4: Drill holes at predetermined positions on the insulating substrate and inject copper into the holes to form conductive channels 31.

[0077] Step 5: The semi-finished plate processed in Step 4 is mechanically or laser-cut according to the specified shape to obtain the miniature medical heating component.

[0078] In this solution, ruthenium paste has high resistivity and excellent thermal conductivity, enabling efficient heat energy conversion and precise temperature control in a small size. Compared with traditional heating wire manufacturing, heating wires made with ruthenium paste and screen printing improve the stability and reliability of miniature medical heating components, especially performing well in high-temperature environments.

[0079] In this specification, the same or similar parts between the various embodiments can be referred to each other. Each embodiment focuses on describing the differences from other embodiments. In particular, the descriptions of the embodiments described later are relatively simple, and the relevant parts can be referred to the descriptions of the foregoing embodiments.

[0080] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A method for manufacturing a mass-producible miniature medical heating component, characterized in that, Includes the following steps: S1, etching or laser cutting a specific pattern of heating wires arranged in an array on the heating substrate; S2, the heat-conducting substrate and the insulating substrate are respectively bonded to the upper and lower surfaces of the heating wire processed in S1 using high-temperature resistant adhesive; S3, Drill holes at predetermined positions on the insulating substrate and inject copper into the holes to form conductive channels; S4, the semi-finished product in S3 is mechanically or laser-cut according to the specified shape to obtain the miniature medical heating component.

2. The method for manufacturing a miniature medical heating component according to claim 1, characterized in that, Between steps S3 and S4, there is also step S31: attaching a temperature sensor at a predetermined position on the insulating substrate, wherein the temperature sensor is any one of a K-type thermocouple, a T-type thermocouple, or a thermistor.

3. The method for manufacturing a miniature medical heating component according to claim 1, characterized in that, The heating substrate material is a nickel-chromium alloy or an iron-chromium-aluminum alloy.

4. A method for manufacturing a miniature medical heating component, characterized in that, Includes the following steps: S1: The resistive paste is screen-printed onto a thermally conductive substrate to form a specific pattern of array arrangement, and then sintered and solidified into a heating wire; S2: In S1, the thermistor material is printed onto the surface of the thermally conductive substrate and then sintered and cured to form a temperature sensor. The heating wire and the temperature sensor are located on the same side of the thermally conductive substrate. S3: The side of the thermally conductive substrate with the heating wire and temperature sensor described in S2 is bonded to the insulating substrate with high-temperature resistant adhesive. S4: Drill holes at predetermined positions on the insulating substrate described in S3, and inject copper into the holes to form conductive channels; S5: The semi-finished product in S4 is mechanically or laser-cut according to the specified shape to obtain the miniature medical heating component.

5. The method for manufacturing a miniature medical heating component according to claim 4, characterized in that, The resistive paste is ruthenium paste.

6. The method for manufacturing a miniature medical heating component according to claim 1 or 4, characterized in that, The thermally conductive substrate is made of ceramic or metal, wherein the ceramic material is any one of aluminum nitride, boron nitride, or silicon carbide; and the metal material is an aluminum alloy.

7. The method for manufacturing a miniature medical heating component according to claim 1 or 4, characterized in that, The specific pattern can be any one of linear, circular, or spiral shapes.

8. The method for manufacturing a miniature medical heating component according to claim 1 or 4, characterized in that, The thickness of the heating wire is between 50 and 100 micrometers, the thickness of the thermally conductive substrate is between 200 and 500 micrometers, the thickness of the insulating substrate is between 25 and 125 micrometers, and the overall thickness of the heating component is between 0.4 and 1.0 mm.

9. The method for manufacturing a miniature medical heating component according to claim 1 or 4, characterized in that, The heating substrate and / or the thermally conductive substrate are coated with a biocompatible insulating coating, which is a paraffin coating or a polytetrafluoroethylene coating.

10. The method for manufacturing a miniature medical heating component according to claim 1 or 4, characterized in that, The high-temperature resistant adhesive is a thermosetting acrylic adhesive or an epoxy resin thermosetting adhesive; the bonding process involves pressing the heating layer, the heat-conducting layer, and the lead wire layer together at a high temperature; the thickness of the adhesive after bonding is between 12 and 50 micrometers.

11. A miniature medical heating component, characterized in that, include: The thermally conductive layer, including the thermally conductive substrate, has a thickness between 200 and 500 micrometers. A heating layer, including a heating wire, wherein the heating wire is fixed to the heat-conducting substrate; The heating wire is any one of linear, annular, and spiral shapes, with a thickness of 50 to 100 micrometers, a resistance range of 0.5Ω to 10Ω, and a heating power of 5W to 50W. The lead layer includes an insulating substrate and a conductive channel, the thickness of which is between 25 and 125 micrometers; the conductive channel includes a hole-like structure disposed on the insulating substrate, and the conductive channel is filled with a conductive material; the insulating substrate is connected to the heating layer by a high-temperature resistant adhesive, and the heat-conducting layer, the heating layer and the lead layer are arranged in layers; A temperature sensor, which is integrated into the lead layer and / or heating layer.

Images