A glue filling molding method and molding device for medical equipment head

Abstract

The present invention relates to a method and device for molding a medical device head with glue, the method comprising the following steps: inserting a medical device housing into a mold, then inserting a metal pin into a flexible sleeve, and inserting the metal pin with a flexible sleeve on the outer surface into a first hole and a second hole reserved in the mold. Next, injecting a glue potting material for forming the medical device head into the mold and waiting for it to solidify. After solidification, the metal pin, the flexible sleeve needle and the mold are removed in turn to obtain a molded medical device head. Compared with the prior art, the present invention reduces the risk of damage to the inner wall of the suture hole and improves manufacturing accuracy and production efficiency.

Description

Technical Field

[0001] The invention relates to the field of medical equipment manufacturing, and in particular to a glue injection molding method and a molding device for a medical equipment head. Background Art

[0002] In the existing medical device manufacturing process, especially in the manufacturing process of implantable medical devices, the molding of the medical device head usually requires glue pouring in a narrow space to ensure its stability and sealing. However, the existing glue pouring molding method has some shortcomings, especially in the process of making suture holes, which often leads to the problem of scratches and damage on the inner wall.

[0003] For example, see Fig. 9 The material of the pin of the suture hole of the implantable cardiac event monitor (ICM) is usually stainless steel with high hardness. When the pin is removed in the cured epoxy resin 504, the rotation of the pin 503 will squeeze the inner wall of the suture hole, causing nicks or scratches. In addition, if there are tiny bubbles 501 around the pin 503 during the curing process, the bubbles will burst when the pin 503 is removed, which will further damage the inner wall of the suture hole, causing internal explosion and cracks 502. These problems seriously affect the service life and reliability of medical equipment.

[0004] The root of these problems is that there is a tolerance in the roundness of the pin during the processing, which causes the cross-section of the pin to be non-circular, and thus the cross-section of the glue hole is also non-circular. When the pin is removed, the stress of the glue hole is concentrated at the relatively fragile position of the structure (such as the bubble), which can easily lead to the rupture of the inner wall of the glue hole, resulting in adverse consequences. Therefore, an improved medical device head glue molding method and molding device are urgently needed to solve the above problems and improve the manufacturing accuracy and durability of medical equipment. Summary of the invention

[0005] The invention relates to a glue pouring molding method and a molding device for a medical device head, aiming to improve the molding quality and precision of the medical device head, reduce stress damage during the processing, and ensure the quality and reliability of the medical device.

[0006] The glue pouring molding method for the head of a medical device comprises the following steps:

[0007] Step S1, inserting the medical device housing into the mold to ensure that the housing is accurately positioned.

[0008] Step S2, inserting the metal pin into the flexible sleeve, and heating the flexible sleeve using a heating device so that the flexible sleeve is tightly attached to the outer surface of the metal pin.

[0009] Step S3, inserting a metal pin with a flexible sleeve on its outer surface into the first hole and the second hole reserved in the mold to form a suture hole positioning of the head of the medical device.

[0010] Step S4, injecting a potting material for forming the head of the medical device into the mold and waiting for it to solidify.

[0011] Step S5, after solidification, the metal pin is removed, and the flexible sleeve absorbs the lateral extrusion generated by the metal pin, thereby reducing the stress generated on the suture hole of the head of the medical device after solidification.

[0012] Step S6, removing the flexible sleeve, the inner wall and outer wall surfaces of which include a lubricating coating to further reduce the resistance during the removal process.

[0013] Step S7, removing the mold to obtain a molded medical device head.

[0014] Furthermore, the flexible sleeve is made of a material with heat shrinkage properties, and inserting the metal pin into the flexible sleeve includes inserting the metal pin into the flexible sleeve and then heating the flexible sleeve using a heating device so that the flexible sleeve is tightly attached to the outer surface of the metal pin.

[0015] In a specific embodiment, the heating device is a hot air gun, and the heating temperature is 180-200 degrees Celsius.

[0016] Furthermore, the thickness of the flexible sleeve needs to meet certain conditions to ensure the concentricity error of the metal pin and the dimensional accuracy of the suture hole. ,

[0017] in,

[0018] It represents the compression modulus of the flexible sleeve;

[0019] Indicates the compressive force applied;

[0020] e represents the concentricity error;

[0021] Indicates the diameter of the suture hole;

[0022] Indicates the length of the suture hole.

[0023] More specifically, the above-mentioned removing the metal pin includes rotating and lifting the metal pin.

[0024] The present invention also provides a glue-filling molding device for a medical device head, comprising:

[0025] A mold, the mold is used to accommodate a medical device housing, and the mold is provided with a first hole and a second hole;

[0026] A metal pin, used to be inserted into the first hole and the second hole and form a suture hole of the head of the medical device in the mold;

[0027] A flexible sleeve is sleeved on the outer surface of the metal pin, and the flexible sleeve absorbs the lateral extrusion generated by the metal pin, thereby reducing the stress generated on the suture hole of the head of the medical device after curing.

[0028] Furthermore, the flexible sleeve is made of a material with heat shrinkability.

[0029] More specifically, the first end of the metal pin includes a blunt separation head, and the second end includes an operating handle; a through hole is provided on the surface of the operating handle for easy operation.

[0030] In a specific embodiment, the concentricity error of the metal pin is 0.01 mm to 0.005 mm; the diameter of the suture hole is 2.2 mm-2.3 mm; the diameter of the metal pin is 1 mm to 2 mm; the initial thickness of the flexible sleeve is 0.1 mm to 0.225 mm; the total diameter of the metal pin whose outer surface is tightly wrapped with the flexible sleeve is 1.2 mm to 2.4 mm.

[0031] Furthermore, the inner wall and outer wall surfaces of the above-mentioned flexible sleeve include a lubricating coating, which further reduces the resistance during the removal process.

[0032] Beneficial effect: The present invention provides a method and device for molding the head of a medical device with glue, which solves the problem that the metal pin is in direct contact with the colloid, which makes it difficult to pull out and the suture hole has low precision in the traditional process; the flexible sleeve adopts a material with heat shrinkage performance, which can not only ensure the precise fit between the metal pin and the mold, but also effectively absorb stress when the metal pin is pulled out, and maintain the integrity and precision of the suture hole; it is simple and practical, suitable for the manufacture of various medical equipment heads that require high-precision molding, improves production efficiency and product quality, and has broad application prospects.

[0033] Compared with the traditional method, the present invention reduces the risk of damage to the inner wall of the suture hole and improves manufacturing accuracy and production efficiency. The present invention provides a method and device for molding a medical device head that can adapt to metal pins and flexible sleeves of different sizes and is suitable for manufacturing medical devices of various specifications.

[0034] In summary, the glue pouring molding method and molding device for the head of a medical device of the present invention significantly improve the manufacturing quality and reliability of implantable medical devices, extend the service life of the equipment, and reduce the defective rate in the production process, providing important technical support for the field of medical device manufacturing. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] Figure 1 The present invention is a structural schematic diagram of a glue-filling and molding device for a medical device head.

[0036] Figure 2 It is a schematic diagram of the structure of the medical device after glue filling.

[0037] Figure 3 It is a structural schematic diagram of inserting the medical device housing into the mold in step S1.

[0038] Figure 4 is a schematic diagram of inserting the metal pin into the flexible sleeve in step S2.

[0039] Figure 5 It is a schematic diagram of inserting the metal pin into the mold and injecting the potting glue in step S3 and step S4.

[0040] Figure 6 is a schematic diagram of removing the metal pins after curing in step S5.

[0041] Figure 7 It is a schematic diagram of removing the flexible sleeve in step S6.

[0042] Figure 8 is a schematic diagram of separating the mold from the medical device head.

[0043] Fig. 9 It is an electron microscope image of the glue filling process of manufacturing implantable medical devices in the prior art.

[0044] Fig.10 It is an electron microscope image of an implantable medical device manufactured using the scheme of the present invention. DETAILED DESCRIPTION

[0045] The specific implementation methods of the present application are further described in detail below in conjunction with the accompanying drawings so that those skilled in the art can better understand the present application. It should be noted that the "glue pouring" mentioned in the present application includes but is not limited to the following processes: glue pouring molding process, injection molding process, vacuum infusion process and casting molding process, etc. The glue pouring molding process refers to a process in which liquid materials (such as resin, silicone, etc.) are poured into a mold or a specific area and the desired shape or function is formed through a curing process.

[0046] Embodiment 1

[0047] Reference Figure 1 The glue injection molding device 100 for the head of the medical device includes a mold 110, a metal pin 130 and a flexible sleeve 150. Figure 2 The medical device 200 includes a medical device housing 201 and a medical device head 202, and a suture hole 203 is provided on the medical device head 202. The medical device head glue injection molding device 100 is intended to realize the molding of the medical device head 202, especially in the process of forming the suture hole 203, by combining the mold 110 with the metal pin 130.

[0048] Furthermore, the mold 110 is used to accommodate the medical device housing 201 .

[0049] The mold 110 includes an opening 111, and the opening 111 is used to receive the medical device housing 201 before the glue is poured. The interior of the mold 110 can withstand the pressure and temperature generated during the glue pouring molding process. The internal structure of the mold 110 accurately corresponds to the shape of the medical device head 202, so that a predetermined product shape can be obtained after the glue is poured and cured.

[0050] More specifically, the mold 110 is provided with two holes specifically used for inserting the metal pin 130, namely the first hole 114 and the second hole 115. The central axes of the first hole 114 and the second hole 115 are on the same straight line, and the central axes are perpendicular to the plane where the mold surface 113 is located, ensuring that the metal pin 130 is accurately positioned inside the mold 110, thereby ensuring the accuracy of the suture hole 203.

[0051] Furthermore, in order to ensure the sealing performance of the mold 110, the diameters of the first hole 114 and the second hole 115 are smaller than the diameter of the metal pin 130. Since the mold 110 has a certain elasticity, it can ensure that the metal pin 130 can be inserted into the mold 110 and fit tightly with the mold 110 to prevent the metal pin 130 from moving during operation. The mold 110 also includes an exhaust channel for exhausting the gas generated therein during the glue pouring process.

[0052] The mold 110 is preferably a silicone mold, which has a certain elasticity.

[0053] The metal pin 130 is used to be inserted into the first hole 114 and the second hole 115, and form the suture hole 203 of the medical device head 202 in the mold 110. The metal pin 130 can provide positioning for the mold 110, and is also a molding component for forming the suture hole 203 during the molding process.

[0054] The material of the metal pin 130 is usually high-strength stainless steel or other corrosion-resistant metal, which can ensure the durability and strength of the metal pin 130 during multiple uses.

[0055] Typically, the metal pin 130 is obtained by machining, and the concentricity of the edge of its cross section has a certain tolerance.

[0056] Furthermore, the first end of the metal pin 130 includes a blunt separation head 131, and the second end includes an operating handle 132. The blunt separation head 131 makes it easy to insert the metal pin 130 into the cavity of the mold 110 during the glue pouring assembly process, and the metal pin 130 can be easily removed after the glue pouring is cured, and the blunt separation head 131 will not damage the finished product. The operating handle 132 is provided with a through hole 133, and the through hole 133 is used to fix the position of the metal pin 130 in the mold 110, or provide additional operating functions in subsequent processes, such as rotation, pulling, etc.

[0057] Furthermore, the flexible sleeve 150 is sleeved on the outer surface of the metal pin 130 , and the flexible sleeve 150 is used to absorb the stress generated when the metal pin 130 rotates in the cured medical device head 202 .

[0058] Furthermore, the flexible sleeve 150 is made of a material with heat shrinkage properties. The material with heat shrinkage properties is a material that can shrink after being heated, so that the flexible sleeve 150 can be tightly wrapped around the outer surface of the metal pin 130 after being heated, providing additional protection and stress absorption function for the metal pin 130.

[0059] Furthermore, the inner wall and outer wall surface of the flexible sleeve 150 include a lubricating coating, which facilitates the insertion and removal of the metal pin 130 and further reduces the resistance during the removal process.

[0060] Furthermore, the thickness of the flexible sleeve 150 needs to meet certain conditions to ensure the concentricity error of the metal pin 130 and the dimensional accuracy of the suture hole 203. More specifically, assuming that the initial thickness of the flexible sleeve 150 is , the final thickness achieved by heating and compression is , then the compressive strain It can be expressed as: .

[0061] Furthermore, the compression modulus of the flexible sleeve With the applied compressive force The relationship is: , where the compression modulus of the flexible sleeve is Related to material properties; applied compressive force is the actual assembly force, i.e., the pressure on the side of the suture hole caused by the non-perfect circle of the metal pin when the metal pin rotates; is the force per unit area. is the force area, and we get , is the diameter of the suture hole, is the length of the suture hole.

[0062] Assuming the final thickness after compression , substituting into the above formula, we get: , where the concentricity error This is a reserved deviation in the design requirement, indicating that the flexible sleeve 150 needs to be compressed within this range eventually.

[0063] Therefore, the initial thickness of the flexible sleeve 150 is The expression is: .

[0064] From the above, it can be seen that the initial thickness The expression takes into account the compression modulus of the flexible sleeve and the compressive force applied and concentricity error , while ensuring a certain concentricity error , applied compressive force and the compression modulus of the flexible sleeve Under the condition of .

[0065] In order to determine the various parameters in the formula, the following steps are required to measure and obtain these parameters:

[0066] First, measure the concentricity error e of the metal pin. Use a high-precision measuring device, such as a concentricity measuring instrument, a laser measuring instrument, or a three-dimensional coordinate measuring machine, fix the metal pin on the measuring device, rotate the metal pin and measure its axis deviation, and record the maximum deviation value as the concentricity error e.

[0067] Next, the compression modulus of the flexible sleeve is obtained through material mechanics testing. Sample the material of the flexible sleeve, prepare a specimen of standard size, perform compression testing using a material testing machine, record the stress-strain curve, and calculate the compression modulus of the flexible sleeve. .

[0068] Then, determine the diameter of the suture hole and the length of the suture hole According to the design requirements of the medical device, obtain the length of the suture hole from the design drawing , or use an inside micrometer and depth gauge to directly measure the stitching hole size of the mold or finished product.

[0069] Finally, the applied compressive force is measured Using a material testing machine, slowly insert the metal pin into the suture hole with the flexible sleeve, record the force-displacement curve during the insertion process, and take the maximum or average insertion force as the applied compression force .

[0070] In a specific embodiment, the concentricity error of the metal pin 130 is 0.01 mm to 0.005 mm; the diameter of the suture hole 203 is 2.2 mm-2.3 mm; the diameter of the metal pin 130 is 1 mm to 2 mm; the initial thickness of the flexible sleeve 150 is 0.1 mm to 0.225 mm; the total diameter of the metal pin 130 whose outer surface is tightly wrapped with the flexible sleeve 150 is 1.2 mm to 2.4 mm.

[0071] In another specific embodiment, by the initial thickness The expressions and necessary parameter measurements can determine that: the diameter of the metal pin 130 is 1.80 mm-1.85 mm; the initial thickness of the flexible sleeve 150 is 0.175 mm-0.225 mm; the total diameter of the metal pin 130 whose outer surface tightly wraps the flexible sleeve 150 is 2.20-2.25 mm.

[0072] Optionally, the material of the flexible sleeve 150 includes silicone, fluororubber, nitrile rubber, polyurethane, natural rubber, etc.

[0073] Embodiment 2

[0074] The present invention provides a method for molding a medical device head by glue pouring, which comprises the following steps.

[0075] Step S1 : inserting the medical device housing 201 into the mold 110 .

[0076] Reference Figure 3 The mold 110 receives the medical device housing 201 through the opening 111. The connection section between the medical device housing 201 and the opening 111 is kept sealed. The front end of the medical device housing 201 also includes an antenna, an electrode, a bracket, and the like.

[0077] In order to improve the sealing performance of the mold 110 , an elastic silicone mold may be used so that the opening 111 can be sealed with the medical device 200 after being stretched open.

[0078] The mold 110 is also provided with a glue filling port and an exhaust channel for completing the glue filling and exhaust processes.

[0079] Optionally, the medical device 200 includes an implantable cardiac monitor, an implantable cardiac pacemaker, an implantable cardiac defibrillator, a sacral nerve stimulator, a brain pacemaker, a bladder stimulator, and the like.

[0080] Step S2 , inserting the metal pin 130 into the flexible sleeve 150 .

[0081] Reference Figure 4 , the inner diameter of the flexible sleeve 150 is the same as the diameter of the metal pin 130, or slightly smaller than the diameter of the metal pin 130. Since the flexible sleeve 150 is elastic, it can ensure that the metal pin 130 can be inserted into the flexible sleeve 150 and prevent the metal pin 130 from sliding. When the flexible sleeve 150 is in an un-heat-shrunk state, its inner diameter is less than or equal to the diameter of the metal pin 130. After the metal pin 130 is inserted into the flexible sleeve 150, the heating device 310 is used to heat the flexible sleeve 150 so that the flexible sleeve 150 is tightly attached to the outer surface of the metal pin 130.

[0082] Optionally, the heating device 310 is a hot air gun, and the heating temperature is 180°C-200°C.

[0083] Step S3 , inserting the metal pin 130 with the flexible sleeve 150 sleeved on the outer surface into the first hole 114 and the second hole 115 reserved in the mold 110 .

[0084] Step S4, injecting the potting material 400 for forming the medical device head 202 into the mold 110 and waiting for it to solidify.

[0085] Reference Figure 5 The glue pouring process is the core of the entire molding process. First, the metal pin 130 with the flexible sleeve 150 is inserted into the first hole 114 and the second hole 115 of the mold 110 to ensure that the metal pin 130 is accurately positioned in the mold 110. Then, the glue pouring material 400 is slowly injected into the mold 110 and waited for it to solidify.

[0086] Optionally, in order to ensure that the potting material 400 can completely fill the mold 110 and wrap the metal pins 130 , a vacuum infusion technology may be used during the potting process to expel air bubbles in the mold 110 .

[0087] Optionally, the potting material 400 is liquid epoxy resin or other suitable potting materials.

[0088] Step S5, removing the metal pins 130 after solidification.

[0089] Reference Figure 6After the mold 110 is filled with the potting material 400, it is necessary to wait for it to be completely cured. As needed, the integral components of the mold 110 and the metal pin 130 after the potting are placed in a constant temperature box for curing. Depending on the type of the potting material 400, ultraviolet irradiation curing can be selected. After the potting material 400 is completely cured, the operator can rotate and lift the metal pin 130 by operating the handle 132. During the rotation process, the flexible sleeve 150 absorbs the lateral extrusion generated by the metal pin 130, thereby reducing the stress generated on the suture hole 203 of the head 202 of the medical device after curing. At the same time, due to the protection of the flexible sleeve 150, the metal pin 130 has no friction with the suture hole 203 when it is pulled out of the mold 110, and will not scratch the suture hole 203.

[0090] Step S6, removing the flexible sleeve 150.

[0091] Reference Figure 7 , and then the flexible sleeve 150 is pulled out from the suture hole 203 to obtain a completed suture hole 203.

[0092] Step S7, removing the mold 110 to obtain the molded medical device head 202.

[0093] Reference Figure 8 , separate the mold 110 from the medical device head 202, and then further polish the residual glue at the glue injection port.

[0094] Optionally, the residual glue is subjected to a secondary treatment by polishing.

[0095] During the glue pouring process, when the glue pouring material 400 is poured into the mold 110 and wraps the metal pin 130, the flexible sleeve 150 can absorb the stress between the metal pin 130 and the solidified glue. These stresses are usually caused by material shrinkage and temperature changes during the curing process of the glue pouring material 400. By using a material with heat shrinkage properties, these stresses can be effectively reduced or eliminated, thereby avoiding stress concentration or material fatigue around the suture hole 203 of the molded medical device head 202.

[0096] The selection and application of the flexible sleeve 150 makes the entire medical device head molding process more reliable, and also improves the durability and safety of the finished product. In particular, in the application of the medical device 200, this stress management measure can significantly reduce the risk of failure of the medical device 200 during use.

[0097] The glue pouring molding method and molding device of the medical device head of the present invention have significant advantages in design and operation: first, the application of the flexible sleeve effectively reduces the stress concentration during the curing process and avoids structural defects of the finished product. Secondly, the design of the blunt separation head and the operating handle makes the operation of the entire glue pouring process more convenient and reduces the difficulty of manual intervention.

[0098] Fig.10 The technical effect of the technical solution of the present application is demonstrated, by using the solution of heating the flexible sleeve 150 to close the metal pin 130, Fig.10 The suture hole 203 shown in the figure has no obvious scratches or damage on its appearance. When the metal pin 130 rotates, the inner wall of the suture hole 203 has no cracks. After the metal pin 130 is pulled out, the inner wall is smooth, and the surface edge 204 of the suture hole 203 is flat and has no burrs. Compared with the traditional method, it can effectively avoid surface damage caused by using a metal pin alone. Fig.10 The edge of the suture hole 203 shown in the figure is very smooth and undamaged, proving that the use of a flexible sleeve can maintain the integrity of the edge of the suture hole 203 during the manufacturing process and avoid damage. Fig.10 205 in the figure is the glue injection residue.

[0099] In summary, the present invention provides a method and device for molding a medical device head through a series of precise designs and process optimizations, and can provide a high-quality medical device head component during the molding process to meet strict medical application requirements.

Claims

1. A method for molding a head of a medical device by pouring glue, characterized in that: The following steps are involved: Step S1, inserting the medical device housing into the mold; Step S2, inserting the metal pin into the flexible sleeve; Step S3, inserting a metal pin with a flexible sleeve on its outer surface into the first hole and the second hole reserved in the mold; Step S4, injecting a potting material for forming the head of the medical device into the mold and waiting for it to solidify; Step S5, removing the metal pin after solidification; Step S6, removing the flexible sleeve; Step S7, removing the mold to obtain a molded medical device head; The flexible sleeve is made of a material with heat shrinkability.

2. A method for molding a medical device head by glue pouring according to claim 1, characterized in that: Inserting the metal pin into the flexible sleeve includes inserting the metal pin into the flexible sleeve and then heating the flexible sleeve using a heating device so that the flexible sleeve is closely attached to the outer surface of the metal pin.

3. A method for molding a medical device head by glue pouring according to claim 2, characterized in that: The heating device is a hot air gun, and the temperature during heating is 180°C-200°C.

4. According to claim 1, a method for molding a medical device head by glue pouring, characterized in that: The removing the metal pin includes rotating and lifting the metal pin.

5. A glue-filling molding device for a medical device head, characterized in that: include: A mold, the mold is used to accommodate a medical device housing, and the mold is provided with a first hole and a second hole; A metal pin, used to be inserted into the first hole and the second hole and form a suture hole of the head of the medical device in the mold; A flexible sleeve is sleeved on the outer surface of the metal pin, and the flexible sleeve is made of a material with heat shrinkability.

6. The glue-filling molding device for the head of a medical device according to claim 5, characterized in that: The first end of the metal pin includes a blunt separation head, and the second end includes an operating handle; a through hole is arranged on the surface of the operating handle.

7. The glue-filling molding device for the head of a medical device according to claim 6, characterized in that: The concentricity error of the metal pin is 0.01 mm to 0.005 mm; the diameter of the suture hole is 2.2 mm-2.3 mm; the diameter of the metal pin is 1 mm to 2 mm; the initial thickness of the flexible sleeve is 0.1 mm to 0.225 mm; the total diameter of the metal pin whose outer surface is tightly wrapped by the flexible sleeve is 1.2 mm to 2.4 mm.

8. The glue-filling molding device for the head of a medical device according to claim 6, characterized in that: The inner and outer wall surfaces of the flexible sleeve include a lubricious coating.

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