WO2024078547A1 - 医疗器械组件和医疗器械组件的连接方法 - Google Patents

医疗器械组件和医疗器械组件的连接方法 Download PDF

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Publication number
WO2024078547A1
WO2024078547A1 PCT/CN2023/124094 CN2023124094W WO2024078547A1 WO 2024078547 A1 WO2024078547 A1 WO 2024078547A1 CN 2023124094 W CN2023124094 W CN 2023124094W WO 2024078547 A1 WO2024078547 A1 WO 2024078547A1
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WO
WIPO (PCT)
Prior art keywords
medical device
joint
device assembly
adhesive
assembly according
Prior art date
Application number
PCT/CN2023/124094
Other languages
English (en)
French (fr)
Inventor
王周斌
顾俊
Original Assignee
丰凯利医疗器械(上海)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 丰凯利医疗器械(上海)有限公司 filed Critical 丰凯利医疗器械(上海)有限公司
Publication of WO2024078547A1 publication Critical patent/WO2024078547A1/zh

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C09—DYES; PAINTS; POLISHES; NATURAL RESINS; ADHESIVES; COMPOSITIONS NOT OTHERWISE PROVIDED FOR; APPLICATIONS OF MATERIALS NOT OTHERWISE PROVIDED FOR
    • C09J—ADHESIVES; NON-MECHANICAL ASPECTS OF ADHESIVE PROCESSES IN GENERAL; ADHESIVE PROCESSES NOT PROVIDED FOR ELSEWHERE; USE OF MATERIALS AS ADHESIVES
    • C09J5/00—Adhesive processes in general; Adhesive processes not provided for elsewhere, e.g. relating to primers
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
    • F16B11/00—Connecting constructional elements or machine parts by sticking or pressing them together, e.g. cold pressure welding
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16B—DEVICES FOR FASTENING OR SECURING CONSTRUCTIONAL ELEMENTS OR MACHINE PARTS TOGETHER, e.g. NAILS, BOLTS, CIRCLIPS, CLAMPS, CLIPS OR WEDGES; JOINTS OR JOINTING
    • F16B5/00—Joining sheets or plates, e.g. panels, to one another or to strips or bars parallel to them

Definitions

  • the present application belongs to the field of medical technology, and in particular to a medical device assembly and a method for connecting the medical device assemblies.
  • An embodiment of the present application provides a medical device assembly that can improve the connection strength of the medical device assembly.
  • the embodiment of the first aspect of the present application provides a medical device assembly, including a body, the body including a first surface and at least one first joint arranged on the first surface, the first joint comprising a first top, a first bottom and a first side connecting the first top and the first bottom, the first top being located on the first surface, the first bottom and the first top being spaced apart along the thickness direction of the body, and the cross-sectional dimension of the first joint in the thickness direction gradually increases or decreases along the direction away from the first surface.
  • the first joint is sunken into the first surface along the thickness direction, and the first top is an opening of the first joint located on the first surface.
  • the first connector is used for placing drugs or adhesives.
  • the drug and the adhesive are placed between the first bottom portion and the first side portion.
  • the first joint protrudes from the first surface along the thickness direction.
  • the first connector is used to attach a drug or an adhesive.
  • the drug and the adhesive are attached to the first bottom portion and/or the first side portion.
  • the main body is in the shape of a circular tube, and the first surface is the outer surface or the inner surface of the circular tube.
  • the inner diameter of the main body is 1-10 mm, and the wall thickness of the main body is 0.1-0.5 mm.
  • each first joint is distributed along the circumference of the main body.
  • a plurality of first joints are arranged at equal intervals on the first surface.
  • the distance between the first bottom and the first top is in the range of 5 ⁇ m-350 ⁇ m.
  • the angle between the first side portion and the first bottom portion is in the range of 0.5°-60°.
  • the first joint is prepared by a femtosecond laser process.
  • the cross-sectional shape of the first joint in the thickness direction is one or more of polygonal, circular, and elliptical.
  • the embodiment of the third aspect of the present application further provides a medical device assembly, including a body, a target An object and a filler, a main body is connected to the target object, the filler is located between the main body and the target object, the filler includes a drug and/or an adhesive, the main body includes a first surface facing the target object and at least one first joint arranged on the first surface, the first joint includes a first top, a first bottom and a first side connecting the first top and the first bottom, the first top is located on the first surface, the first bottom and the first top are spaced apart along the thickness direction of the main body, the cross-sectional size of the first joint in the thickness direction gradually increases or decreases along the direction away from the first surface, and at least part of the filler is located in the first joint or attached to the surface of the first joint.
  • an embodiment of the third aspect of the present application also provides a method for connecting a medical device assembly, which is used to connect the medical device assembly as described above and a target component, wherein one of the medical device assembly and the target component is made of metal, and the other is made of a polymer material or plastic, and the connection method includes: applying an adhesive on the first surface, at least partially covering the first joint with the adhesive; placing the target component toward the first surface, pressurizing and heating the target component and the medical device assembly, so that the adhesive is hot-melted and adheres between the target component and the medical device assembly; cooling the medical device assembly and the target component, so that the medical device assembly and the target component are connected as one through the adhesive.
  • the adhesive is at least one of thermoplastic polyurethane and fusible polytetrafluoroethylene.
  • the adhesive and the target component are made of the same material.
  • the medical device assembly of the embodiment of the present application includes a body and a first surface and a first joint on the body, the first joint includes a first top and a first bottom spaced apart in the thickness direction, and a first side connecting the first top and the first bottom, the first top is located on the first surface; by gradually increasing or decreasing the cross-sectional dimension of the first joint in the thickness direction in the direction away from the first surface, the accommodation volume and surface area of the first joint are increased, so that the first joint can accommodate and attach more adhesive, thereby improving the connection strength of the medical device assembly.
  • the force of the first joint on the adhesive offsets a part of the axial tension on the adhesive, so that the axial tension on the adhesive at the first joint is smaller than the actual axial tension, further improving the connection strength of the medical device assembly.
  • FIG1 is a front view schematic diagram of the structure of a medical device assembly according to some embodiments of the present application.
  • Fig. 2 shows a cross-sectional view of the medical device assembly in Fig. 1 at section A-A;
  • FIG3 shows a partial enlarged view of the medical device assembly in FIG2 at position M;
  • FIG4 is a front view schematic diagram showing the structure of a medical device assembly of a second example
  • Fig. 5 shows a cross-sectional view of the medical device assembly in Fig. 4 at section B-B;
  • FIG6 shows a partial enlarged view of the medical device assembly in FIG5 at position N;
  • FIG. 7 shows a cross-sectional view of the medical device assembly in FIG. 1 at section A-A of another example
  • FIG8 is a front view schematic diagram showing the structure of a medical device assembly of a third example.
  • Fig. 9 shows a cross-sectional view of the medical device assembly in Fig. 8 at section C-C;
  • Fig. 10 shows a cross-sectional view of the medical device assembly in Fig. 8 at section D-D;
  • FIG11 is a front view schematic diagram showing the structure of a medical device assembly of a fourth example.
  • Fig. 12 shows a cross-sectional view of the medical device assembly in Fig. 11 at section E-E;
  • FIG13 is a front view schematic diagram showing the structure of a medical device assembly of a fifth example.
  • FIG14 shows a cross-sectional view of the medical device assembly in FIG13 at section F-F;
  • FIG15 is a front view schematic diagram showing a medical device assembly and a drug according to an embodiment
  • FIG16 shows a cross-sectional view of the medical device assembly and the drug in FIG15 at section G-G;
  • FIG17 is a front view schematic diagram of a medical device assembly, a target component, and an adhesive according to some embodiments of the present application;
  • FIG18 shows a cross-sectional view of the medical device assembly, target component, and adhesive in FIG17 taken along section H-H;
  • FIG. 19 shows another example cross-sectional view of the medical device assembly, target component, and adhesive in FIG. 17 taken along section H-H;
  • FIG20 shows a cross-sectional view of a medical device assembly of a sixth example
  • FIG21 shows a cross-sectional view of a medical device assembly of a seventh example
  • FIG. 22 shows a cross-sectional view of a medical device assembly of an eighth example.
  • a medical device assembly including a main body, the main body including a first surface and at least one first joint arranged on the first surface, the first joint including a first top, a first bottom and a first side connecting the first top and the first bottom, the first top is located on the first surface, the first bottom and the first top are spaced apart along the thickness direction of the main body, and the cross-sectional size of the first joint in the thickness direction gradually increases or decreases in the direction away from the first surface.
  • the medical device assembly provided in the present application comprises a body, a first surface on the body and a first joint, wherein the first joint comprises a first top and a first bottom spaced apart in a thickness direction, and a first side portion connecting the first top and the first bottom, and the cross-sectional dimension of the first joint in the thickness direction is gradually increased or The first joint gradually decreases, thereby increasing the accommodation volume and surface area of the first joint, so that the first joint can accommodate and attach more adhesive, thereby improving the connection strength of the medical device assembly.
  • the force of the first joint on the adhesive offsets part of the axial tension on the adhesive, so that the axial tension on the adhesive at the first joint is smaller than the actual axial tension, further improving the connection strength of the medical device assembly.
  • Figure 1 is a front view structural schematic diagram of the medical device assembly of some embodiments of the present application
  • Figure 2 shows a cross-sectional view of the medical device assembly in Figure 1 at the A-A section
  • Figure 3 shows a partial enlarged view of the medical device assembly in Figure 2 at the M position.
  • the present application provides a medical device assembly 10, including a body 11, the body 11 including a first surface 12 and at least one first joint 20 disposed on the first surface 12.
  • the first joint 20 includes a first top 21, a first bottom 22, and a first side 23 connecting the first top 21 and the first bottom 22.
  • the first top 21 is located on the first surface 12, the first bottom 22 and the first top 21 are spaced apart along the thickness direction (x direction in the figure) of the body 11, and the cross-sectional dimension of the first joint 20 in the thickness direction x gradually increases or decreases in the direction away from the first surface 12.
  • the first bottom 22 can be understood as the end of the first joint 20 farthest from the first surface 12 .
  • the cross-sectional dimension of the first joint 20 in the thickness direction x can be understood as the dimension of the cross-sectional shape of the first joint 20 perpendicular to the thickness direction x, or can be understood as the dimension of the cross-sectional shape of the first joint 20 intercepted by a section parallel to the first surface.
  • the first surface 12 can be understood as a solid surface on the body 11, or as an extended surface where the solid surface on the body 11 is located.
  • the first top 21 is an opening on the first surface 12.
  • the medical device assembly 10 provided in this embodiment includes a body 11 and a first surface 12 and a first connector 20 on the body 11.
  • the first connector 20 includes a first top 21 and a first bottom 22 spaced apart along a thickness direction x, and a first side portion 23 connecting the first top 21 and the first bottom 22.
  • the first top 21 is located on the first surface 12.
  • the accommodation volume and surface area of the first connector 20 are increased, so that the first connector 20 can accommodate and attach Secondly, by gradually increasing or decreasing the cross-sectional dimension of the first joint 20 in the thickness direction in the direction away from the first surface 12, when the medical device assembly is subjected to axial tension, the force of the first joint 20 on the adhesive offsets part of the axial tension on the adhesive, so that the axial tension on the adhesive at the first joint 20 is smaller than the actual axial tension, further improving the connection strength of the medical device assembly.
  • the first joint 20 is sunken in the first surface 12 along the thickness direction, that is, the first joint 20 is a groove on the first surface 12, the first bottom 22 and the first side 23 are sunken in the first surface 12, the first bottom 22 is the bottom surface of the groove, and the first top 21 is the opening of the first joint 20 located on the first surface 12.
  • the first joint 20 is a notch sunk in the first surface 12 along the thickness direction x.
  • the first joint 20 gradually increases in the thickness direction x in a direction away from the first surface 12 .
  • the medical device assembly 10 provided in this embodiment has a first joint 20 sunken in the first surface 12 and the cross-sectional dimension of the first joint 20 in the thickness direction x gradually increases in the direction away from the first surface 12, so that a receiving groove 24 recessed into the first joint 20 is formed between the first side portion 23 and the first bottom portion 22.
  • the adhesive is not easily separated from the body 11 due to the presence of the receiving groove 24, thereby improving the connection strength of the medical device assembly 10.
  • Figure 4 shows a front view of the medical device assembly of the second example
  • Figure 5 shows a cross-sectional view of the medical device assembly in Figure 4 at the B-B section
  • Figure 6 shows a partial enlarged view of the medical device assembly in Figure 5 at the N position.
  • the first joint 20 protrudes from the first surface 12 along the thickness direction x, that is, the first joint 20 is a protrusion on the first surface 12, the first top 21 is located on the first surface 12, the first bottom 22 and the first side 23 protrude from the first surface 12, and the first bottom 22 is the top surface of the protrusion.
  • the first joint 20 gradually increases in the thickness direction x in a direction away from the first surface 12 .
  • the medical device assembly 10 provided in this embodiment has a first joint 20 protruding from the first surface 12 and a cross-sectional dimension of the first joint 20 in the thickness direction x that gradually increases in a direction away from the first surface 12, so that a receiving groove 24 that is recessed into the interior of the first joint 20 is formed between the first side portion 23 and the first surface 12.
  • the adhesive is not easily separated from the main body 11 due to the presence of the receiving groove 24, thereby improving the connection strength of the medical device assembly 10.
  • the spacing between the first bottom 22 and the first top 21 is in the range of 5 ⁇ m-350 ⁇ m, so that the size of the first joint 20 matches the microstructure of the microconnector.
  • the spacing between the first bottom 22 and the first top 21 is the height of the protrusion; when the first joint 20 is a groove, The distance between the first bottom portion 22 and the first top portion 21 is equal to the depth of the groove.
  • the angle between the first side portion 23 and the first surface 12 is in the range of 0.5°-60°, that is, the angle between at least one first side portion 23 and the first surface 12 is an acute angle.
  • the medical device assembly 10 sets the angle between the first side portion 23 and the first bottom portion 22 within the range of 0.5°-60°.
  • An excessively large angle between the first side portion 23 and the first bottom portion 22 will reduce the volume of the receiving groove 24, thereby reducing the amount of adhesive that can be accommodated in the receiving groove 24, affecting the connection strength of the medical device assembly 10.
  • an excessively large angle between the first side portion 23 and the first surface 12 will also increase the difficulty of preparing the first joint 20.
  • the first joint 20 is prepared by a femtosecond laser process, and the angle between the first side portion 23 and the first surface 12 and the shape of the first joint 20 are controlled by controlling the incident angle of the laser beam.
  • the laser beam removes a certain thickness of the area on the first surface 12 except the first joint 20, so that the entire first surface 12 sinks, and then the first joint 20 protrudes from the first surface 12.
  • the laser beam removes a certain thickness of the area on the first surface 12 where the first joint 20 is located, so that the first joint 20 sinks into the first surface 12.
  • the medical device component 10 provided in this embodiment is prepared with a first joint 20 through a femtosecond laser process.
  • the extremely short pulse laser in the femtosecond laser process can directly convert the material from a solid state to a gas state. There is no hot melt zone after the material evaporates, thereby eliminating chemical contamination on the medical device component 10.
  • Figure 7 shows a cross-sectional view of the medical device assembly in Figure 1 at section A-A of another example.
  • the cross-sectional shape of the first joint 20 can be one or more polygonal shapes.
  • the cross-sectional shape of the first joint 20 in the extension direction is a quadrilateral, that is, the two sides of the first bottom 22 are respectively connected to the two first side portions 23, and the two first side portions 23 can both form an acute angle with the first surface 12 (as shown in FIG. 2).
  • one first side portion 23 can form an acute angle with the first surface 12, and the other first side portion 23 can be perpendicular to the first surface 12 (as shown in FIG. 7).
  • Figure 8 shows a front view structural schematic diagram of the medical device assembly of the third example
  • Figure 9 shows a cross-sectional view of the medical device assembly in Figure 8 at the C-C section
  • Figure 10 shows a cross-sectional view of the medical device assembly in Figure 8 at the D-D section.
  • the cross-sectional shape of the first joint 20 in the thickness direction x is one or more of a polygon (as shown in FIGS. 8 to 10 ), a semicircle, and a semi-ellipse.
  • the cross-sectional shape of the first joint 20 in the thickness direction x is an isosceles triangle or an equilateral triangle.
  • the body 11 is in the shape of a circular tube, and the first surface 12 is the outer surface or the inner surface of the circular tube.
  • the inner diameter of the body 11 is 1-10 mm, and the wall thickness is 0.1-0.5 mm.
  • the preferred inner diameter of the body 11 is 2-6 mm, and the preferred wall thickness is 0.1-0.3 mm.
  • Figure 11 shows a front view structural schematic diagram of another example of a medical device assembly
  • Figure 12 shows a cross-sectional view of an example of the medical device assembly in Figure 11 at the E-E section.
  • each first joint 20 is distributed along the circumference of the body 11 .
  • a plurality of first joints 20 are arranged at equal intervals on the first surface to further improve the connection strength of the medical device assembly.
  • the number of first side portions 23 in each first joint 20 may be one or more, and the number of first side portions 23 in the first joint 20 is related to the cross-sectional shape of the first joint 20 in the thickness direction x.
  • the cross-sectional shape of the first joint 20 in the thickness direction x is circular or elliptical
  • the number of first side portions 23 in the first joint 20 is 1.
  • the cross-sectional shape of the first joint 20 in the thickness direction x is a polygon
  • the number of first side portions 23 in the first joint 20 is the same as the number of sides of the polygon.
  • Figure 13 shows a front view structural schematic diagram of the medical device assembly of the fifth example
  • Figure 14 shows a cross-sectional view of the medical device assembly in Figure 13 at the F-F section.
  • the medical device assembly 10 may also be in the shape of a flat plate.
  • the first joint 20 is sunken in the first surface 12 along the thickness direction x, and the first joint 20 is used to place the drug 30 and/or the adhesive 50, and the drug 30 and the adhesive 50 are placed in the receiving groove 24 formed between the first bottom 22 and the first side portion 23.
  • the first joint 20 is used to place the drug 30 and/or the adhesive 50, which means that the first joint 20 can place one of the drug 30 and the adhesive 50, or a combination of the drug 30 and the adhesive 50.
  • Figure 15 shows a front view structural schematic diagram of a medical device assembly and a drug in an embodiment
  • Figure 16 shows a cross-sectional view of the medical device assembly and the drug in Figure 15 at the G-G section.
  • the first connector 20 is sunken into the first surface 12 along the thickness direction x, and the first connector 20 is used for placing the drug 30 .
  • the stents are usually balloon-expandable stents. If memory alloys are used as platforms, it is necessary to If the stent is delivered by means of a sheath, the outer surface of the stent will rub against the inner surface of the sheath, which may easily cause the drug 30 to fall off.
  • the medical device assembly 10 provided in this embodiment has a first joint 20 sunken into the first surface 12 and a cross-sectional dimension of the first joint 20 in the thickness direction x gradually increasing in a direction away from the first surface 12, so that a receiving groove 24 recessed into the interior of the first joint 20 is formed between the first side portion 23 and the first bottom portion 22.
  • the drug 30 can be accommodated in the recessed first joint 20.
  • the recessed receiving groove 24 improves the connection strength between the drug 30 and the medical device assembly 10 and reduces the probability of the drug 30 falling off the medical device assembly 10.
  • the first connector 20 when the first connector 20 protrudes from the first surface 12 , the first connector 20 can be used to attach the drug 30 and/or the adhesive 50 , and the drug 30 and the adhesive 50 are attached to the surface of the first bottom portion 22 and/or the first side portion 23 .
  • the first connector 20 is used to attach the drug 30 and/or the adhesive 50, which means that the first connector 20 can attach one of the drug 30 and the adhesive 50, or a combination of the drug 30 and the adhesive 50.
  • the drug 30 and the adhesive 50 can also be placed in the accommodating groove 24 formed between the first bottom 22 and the first side 23.
  • Figure 20 shows a cross-sectional view of the medical device assembly of the sixth example
  • Figure 21 shows a cross-sectional view of the medical device assembly of the seventh example
  • Figure 22 shows a cross-sectional view of the medical device assembly of the eighth example.
  • the cross-sectional dimension of the first joint 20 in the thickness direction x gradually decreases in a direction away from the first surface 12.
  • the first joint 20 is sunken into the first surface 12 along the thickness direction x.
  • the drug 30 and the adhesive 50 are placed in the first joint 20 .
  • the first connector 20 protrudes from the first surface 12 along the thickness direction x.
  • the drug 30 and the adhesive 50 are attached to the surface of the first bottom portion 22 and/or the first side portion 23 .
  • the cross-sectional shape of the first joint 20 in the perpendicular thickness direction x is at least one of an isosceles triangle, an equilateral triangle, a semicircle, and a semi-ellipse.
  • the medical device assembly provided by the present application improves the dimensional uniformity between the first joints 20 by making the dimensional regularity of the first joints 20 in the thickness direction x change, thereby improving the connection strength of the medical device assembly.
  • the present application also provides a medical device assembly, including a body 11, a target object 40 and a filler.
  • the body 11 is connected to the target object 40, and the filler is located between the body 11 and the target object 40.
  • the filler includes a drug and/or an adhesive.
  • the body 11 includes a first surface 12 facing the target object 40 and at least one first joint 20 disposed on the first surface 12.
  • the first joint 20 includes a first top 21, a first bottom 22 and a first side portion 23 connecting the first top portion 21 and the first bottom portion 22.
  • the first top portion 21 is located on the first surface 12, the first bottom portion 22 and the first top portion 21 are spaced apart along the thickness direction x of the body 11, the cross-sectional dimension of the first joint 20 in the thickness direction x gradually increases or decreases along a direction away from the first surface 12, and at least part of the filler is located in the first joint 20 or attached to the surface of the first joint 20.
  • the filler includes the drug 30 and/or the adhesive 50 , which means that the filler can be one of the drug 30 and the adhesive 50 , or a combination of the drug 30 and the adhesive 50 .
  • Figure 17 is a schematic diagram of the front view structure of the medical device assembly, target component and adhesive of some embodiments of the present application
  • Figure 18 is a cross-sectional view of the medical device assembly, target component and adhesive in Figure 17 at the H-H section.
  • the present application also provides a method for connecting a medical device assembly 10, which is used to connect the medical device assembly 10 and the target component 40 as described above, wherein one of the medical device assembly 10 and the target component 40 is supported by metal and the other is made of a polymer material.
  • the connection method includes:
  • Step S1 applying adhesive 50 on the first surface 12, at least part of the adhesive 50 covers the first joint 20;
  • Step S2 with the second surface 41 of the target component 40 facing the first surface 12, applying pressure and heat to the target component 40 and the medical device assembly 10, so that the adhesive 50 is hot-melted and attached between the target component 40 and the medical device assembly 10;
  • Step S3 cooling the medical device assembly 10 and the target component 40 , so that the medical device assembly 10 and the target component 40 are connected together via the adhesive 50 .
  • step S2 when the medical device assembly 10 and the target component 40 are both in the form of a flat plate, in step S2, the first surface 12 faces the second surface 41.
  • the target component 40 is sleeved on the outer surface of the medical device assembly 10
  • the first surface 12 is the outer surface of the medical device assembly 10.
  • the medical device assembly 10 is sleeved on the outer surface of the target component 40
  • the first surface 12 is the inner surface of the medical device assembly 10.
  • step S1 when the first joint 20 is a groove on the first surface 12, the adhesive 50 covers the first joint 20 until the first joint 20 is filled until the upper surface of the adhesive 50 is flush with the first top 21 or the first joint 20 extends from the first top 21.
  • the adhesive 50 covers the first joint 20, and the receiving groove 24 formed on the first bottom 22 and between the first side portion 23 and the first surface 12 should be covered with the adhesive 50, and the adhesive 50 on the first bottom 22 is connected to the adhesive 50 in the receiving groove 24.
  • connection method of the medical device assembly 10 uses the first joint 20 and the adhesive 50 coated on the first joint 20, and the receiving groove 24 on the first joint 20 to improve the connection between the adhesive 50 and the medical device assembly 10. Improve the joint strength and reduce the risk of connection failure when using adhesive bonding technology to connect different materials.
  • the adhesive 50 is at least one of thermoplastic polyurethane (TPU) and fusible polytetrafluoroethylene (PFA).
  • TPU thermoplastic polyurethane
  • PFA fusible polytetrafluoroethylene
  • the adhesive 50 and the target component 40 are made of the same material.
  • the adhesive 50 and the target component 40 are simultaneously hot-melted. After the target component 40 and the medical device assembly 10 are cooled, the adhesive 50 and the target component 40 are remolded to become one. At this time, the target component 40 is firmly connected to the medical device assembly 10 due to the presence of the first joint 20.
  • Figure 19 shows a cross-sectional view of the medical device assembly, target component and adhesive in Figure 17 at the H-H section of another example.
  • the second surface 41 is further provided with a second joint 42, which is a protrusion or a groove on the second surface 41.
  • the first joint 20 is a protrusion
  • the second joint 42 is a groove
  • the adhesive 50 is filled between the first joint 20 and the second joint 42.
  • the first joint 20 is a groove
  • the second joint 42 is a protrusion
  • the second joint 42 extends into the first joint 20
  • the adhesive 50 is filled between the first joint 20 and the second joint 42.
  • connection method of the medical device assembly 10 increases the contact area between the adhesive 50 and the medical device assembly 10 and the target component 40 through the first joint 20 and the second joint 42, thereby increasing the connection strength between the medical device assembly 10 and the target component 40.
  • the medical device assembly 10 provided in this embodiment includes a main body 11 and a first surface 12 and a first joint 20 on the main body 11.
  • the first joint 20 includes a first top 21 and a first bottom 22 arranged at intervals along the thickness direction x, and a first side portion 23 connecting the first top 21 and the first bottom 22.
  • the first top 21 is located on the first surface 12.
  • the first side portion 23 forms a receiving groove 24 recessed into the interior of the first joint 20.

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  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Electrotherapy Devices (AREA)
  • Lining Or Joining Of Plastics Or The Like (AREA)

Abstract

一种医疗器械组件(10)，包括本体(11)，本体(11)包括第一表面(12)和设置于第一表面(12)的至少一个第一接头(20)，第一接头(20)包括第一顶部(21)、第一底部(22)和连接第一顶部(21)、第一底部(22)的第一侧部(23)，第一顶部(21)位于第一表面(12)，第一底部(22)和第一顶部(21)沿本体(11)的厚度方向(x)间隔设置，第一接头(20)在厚度方向(x)的截面尺寸沿远离第一表面(12)的方向逐渐增大或逐渐减小。

Description

医疗器械组件和医疗器械组件的连接方法
相关申请的交叉引用
本申请要求享有于2022年10月11日提交的名称为“医疗器械组件和医疗器械组件的连接方法”的中国专利申请202211243098.4的优先权，该申请的全部内容通过引用并入本文中。
技术领域
本申请属于医疗技术领域，尤其涉及医疗器械组件和医疗器械组件的连接方法。
背景技术
人们对医疗水平的期待随着经济水平的发展而提高，对医疗器械的需求也越来越多，需要的医疗器械的功能越来越复杂，单一材料难以满足医疗器械的多功能需求，往往需要多种材料的联合使用。需要弹性和柔性的时候，会考虑高分子材料，而需要高强度的时候，会优先考虑金属材料或无机非金属材料。因此，医疗器械组件中，存在很多不同材料部件之间的连接。不同材料部件之间的连接根据材质的不同可采用焊接、粘接等措施。焊接的效率高、可靠性好，被广泛使用。但如高分子与金属、陶瓷与金属、或者高分子与陶瓷等之间，由于物性相差太大，无法采用焊接方式进行连接。
但是，医生在使用上述医疗器械组件时往往会产生包括推拉、弯折、扭等在内的动作，因此器械的良好的机械性能是基本需求。现有的存在不同材料部件之间连接的医疗器械的连接，容易发生轴向分离断裂。比如，器械的轴向分离断裂就是介入医疗器械的主要不良事件，一旦发生往往需要二次手术以取出留在体内的部分，给患者造成进一步损害。
发明内容
本申请实施例提供一种医疗器械组件，能够提高医疗器械组件的连接强度。
本申请第一方面的实施例提供一种医疗器械组件，包括本体，本体包括第一表面 和设置于第一表面的至少一个第一接头，第一接头包括第一顶部、第一底部和连接第一顶部、第一底部的第一侧部，第一顶部位于第一表面，第一底部和第一顶部沿本体的厚度方向间隔设置，第一接头在厚度方向的截面尺寸沿远离第一表面的方向逐渐增大或逐渐减小。
根据本申请第一方面的实施方式，第一接头沿厚度方向下沉于第一表面，第一顶部为第一接头位于第一表面的开口。
根据本申请第一方面前述任一的实施方式，第一接头用于放置药物或粘合剂。
根据本申请第一方面前述任一的实施方式，药物、粘合剂放置于第一底部和第一侧部之间。
根据本申请第一方面前述任一的实施方式，第一接头沿厚度方向凸起于第一表面。
根据本申请第一方面前述任一的实施方式，第一接头用于附着药物或粘合剂。
根据本申请第一方面前述任一的实施方式，药物、粘合剂附着于第一底部和/或第一侧部。
根据本申请第一方面前述任一的实施方式，本体呈圆管状，第一表面为圆管的外表面或内表面。
根据本申请第一方面前述任一的实施方式，本体的内径为1-10mm，本体的壁厚为0.1-0.5mm。
根据本申请第一方面前述任一的实施方式，第一接头为多个，各第一接头沿本体的周向分布本体。
根据本申请第一方面前述任一的实施方式，多个第一接头等间距的设置在第一表面。
根据本申请第一方面前述任一的实施方式，第一底部与第一顶部之间的间距在5μm-350μm的范围内。
根据本申请第一方面前述任一的实施方式，第一侧部与第一底部之间的夹角在0.5°-60°的范围内。
根据本申请第一方面前述任一的实施方式，第一接头通过飞秒激光工艺制备。
根据本申请第一方面前述任一的实施方式，第一接头在厚度方向上的横截面形状为多边形、圆形、椭圆形中的一种或多种。
另一方面，本申请第三方面的实施例还提供一种医疗器械组件，包括本体、目标 物件和填充物，本体与目标物件连接，填充物位于本体和目标物件之间，填充物包括药物和/或粘合剂，本体包括朝向目标物件的第一表面和设置于第一表面的至少一个第一接头，第一接头包括第一顶部、第一底部和连接第一顶部、第一底部的第一侧部，第一顶部位于第一表面，第一底部和第一顶部沿本体的厚度方向间隔设置，第一接头在厚度方向的截面尺寸沿远离第一表面的方向逐渐增大或逐渐减小，至少部分填充物位于第一接头内或附着在第一接头的表面。
另一方面，本申请第三方面的实施例还提供一种医疗器械组件的连接方法，用于连接如上所述的医疗器械组件与目标部件，医疗器械组件与目标部件的其中一个由金属制成，另一个由高分子材料或塑料制成，连接方法包括：在第一表面上涂覆粘合剂，至少部分粘合剂覆盖第一接头；将目标部件朝向第一表面，向目标部件与医疗器械组件加压与加热，使粘合剂热熔并附着在目标部件与医疗器械组件之间；将医疗器械组件与目标部件冷却，使医疗器械组件与目标部件通过粘合剂连接一体。
根据本申请第三方面的实施方式，粘合剂为热塑性聚安酯、可熔性聚四氟乙烯中的至少一种。
根据本申请第三方面前述任一的实施方式，粘合剂与目标部件的材质相同。
本申请实施例的医疗器械组件，包括本体和本体上的第一表面与第一接头，第一接头包括沿厚度方向间隔设置的第一顶部和第一底部，以及连接第一顶部和第一底部的第一侧部，第一顶部位于第一表面；通过使第一接头在厚度方向的截面尺寸沿远离第一表面的方向逐渐增大或逐渐减小，提高第一接头的容纳体积和表面积，使得第一接头能容纳、附着更多粘合剂，进而提高医疗器械组件的连接强度。其次，通过使第一接头在厚度方向的截面尺寸沿远离第一表面的方向逐渐增大或逐渐减小，使得医疗器械组件受到沿轴向的拉力时，第一接头对粘合剂的作用力抵消一部分粘合剂受到的轴向拉力，使得第一接头处的粘合剂受到的轴向拉力比实际轴向拉力小，进一步提高医疗器械组件的连接强度。
附图说明
为了更清楚地说明本申请实施例的技术方案，下面将对本申请实施例中所需要使用的附图作简单地介绍，显而易见地，下面所描述的附图仅仅是本申请的一些实施例， 对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本申请一些实施例的医疗器械组件的正视结构示意图；
图2示出图1中的医疗器械组件在A-A截面的剖视图；
图3示出图2中的医疗器械组件在M位置的局部放大图；
图4示出第二示例的医疗器械组件的正视结构示意图；
图5示出图4中的医疗器械组件在B-B截面的剖视图；
图6示出图5中的医疗器械组件在N位置的局部放大图；
图7示出另一种示例的图1中的医疗器械组件在A-A截面的剖视图；
图8示出第三示例的医疗器械组件的正视结构示意图；
图9示出图8中的医疗器械组件在C-C截面的剖视图；
图10示出图8中的医疗器械组件在D-D截面的剖视图；
图11示出第四示例的医疗器械组件的正视结构示意图；
图12示出图11中的医疗器械组件在E-E截面的剖视图；
图13示出第五示例的医疗器械组件的正视结构示意图；
图14示出图13中的医疗器械组件在F-F截面的剖视图；
图15示出一种实施例的医疗器械组件和药物的正视结构示意图；
图16示出图15中的医疗器械组件和药物在G-G截面的剖视图；
图17为本申请一些实施例的医疗器械组件、目标部件和粘合剂的正视结构示意图；
图18示出图17中的医疗器械组件、目标部件和粘合剂在H-H截面的剖视图；
图19示出另一种示例的图17中的医疗器械组件、目标部件和粘合剂在H-H截面的剖视图；
图20示出第六示例的医疗器械组件的剖视图；
图21示出第七示例的医疗器械组件的剖视图；
图22示出第八示例的医疗器械组件的剖视图。
附图标记：
10、医疗器械组件；11、本体；12、第一表面；
20、第一接头；21、第一顶部；22、第一底部；23、第一侧部；24、容置槽；
30、药物；40、目标部件；41、第二表面；42、第二接头；50、粘合剂；
x、本体的厚度方向。
具体实施方式
下面将详细描述本申请的各个方面的特征和示例性实施例，为了使本申请的目的、技术方案及优点更加清楚明白，以下结合附图及具体实施例，对本申请进行进一步详细描述。应理解，此处所描述的具体实施例仅意在解释本申请，而不是限定本申请。对于本领域技术人员来说，本申请可以在不需要这些具体细节中的一些细节的情况下实施。下面对实施例的描述仅仅是为了通过示出本申请的示例来提供对本申请更好的理解。
需要说明的是，在本文中，诸如第一和第二等之类的关系术语仅仅用来将一个实体或者操作与另一个实体或操作区分开来，而不一定要求或者暗示这些实体或操作之间存在任何这种实际的关系或者顺序。而且，术语“包括”、“包含”或者其任何其他变体意在涵盖非排他性的包含，从而使得包括一系列要素的过程、方法、物品或者设备不仅包括那些要素，而且还包括没有明确列出的其他要素，或者是还包括为这种过程、方法、物品或者设备所固有的要素。在没有更多限制的情况下，由语句“包括……”限定的要素，并不排除在包括所述要素的过程、方法、物品或者设备中还存在另外的相同要素。
申请人发现在相关技术中，不同材质的医疗器械之间，无法采用焊接方式进行连接。而采用胶接方式时，需要对材料表面进行粗化处理，但传统的表面粗化方式，粘接效果不好，容易在轴向分离断裂或脱落。
鉴于上述问题，申请人提出一种医疗器械组件，包括本体，本体包括第一表面和设置于第一表面的至少一个第一接头，第一接头包括第一顶部、第一底部和连接第一顶部、第一底部的第一侧部，第一顶部位于第一表面，第一底部和第一顶部沿本体的厚度方向间隔设置，第一接头在厚度方向的截面尺寸沿远离第一表面的方向逐渐增大或逐渐减小。
本申请提供的医疗器械组件，包括本体和本体上的第一表面与第一接头，第一接头包括沿厚度方向间隔设置的第一顶部和第一底部，以及连接第一顶部和第一底部的第一侧部，通过使第一接头在厚度方向的截面尺寸沿远离第一表面的方向逐渐增大或 逐渐减小，提高第一接头的容纳体积和表面积，使得第一接头能容纳、附着更多粘合剂，进而提高医疗器械组件的连接强度。其次，通过使第一接头在厚度方向的截面尺寸沿远离第一表面的方向逐渐增大或逐渐减小，使得医疗器械组件受到沿轴向的拉力时，第一接头对粘合剂的作用力抵消一部分粘合剂受到的轴向拉力，使得第一接头处的粘合剂受到的轴向拉力比实际轴向拉力小，进一步提高医疗器械组件的连接强度。
下面结合附图对本申请实施例所提供的医疗器械组件进行介绍。在此说明，附图中的x方向为本体的厚度方向。在附图中，为了方便绘图，图中的尺寸与现实尺寸并不一定成比例。
请参考图1至图3，图1为本申请一些实施例的医疗器械组件的正视结构示意图；图2示出图1中的医疗器械组件在A-A截面的剖视图；图3示出图2中的医疗器械组件在M位置的局部放大图。
如图1和图3所示，本申请提供一种医疗器械组件10，包括本体11，本体11包括第一表面12和设置于第一表面12的至少一个第一接头20。第一接头20包括第一顶部21、第一底部22和连接第一顶部21、第一底部22的第一侧部23。第一顶部21位于第一表面12，第一底部22和第一顶部21沿本体11的厚度方向(图中的x方向)间隔设置，第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐增大或逐渐减小。
可选的，当第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐减小时，第一底部22可以理解为第一接头20距离第一表面12最远的端部。
可选的，第一接头20在厚度方向x的截面尺寸可以理解为第一接头20垂直厚度方向x的截面形状的尺寸，也可以理解为第一接头20被平行于第一表面的截面所截取的截面形状的尺寸。
可选的，第一表面12可以理解为本体11上的实体表面，也可以理解为本体11上实体表面所在的延伸面，例如当第一接头20下沉于第一表面12时，第一顶部21为第一表面12上的开口。本实施例提供的医疗器械组件10，包括本体11和本体11上的第一表面12与第一接头20，第一接头20包括沿厚度方向x间隔设置的第一顶部21和第一底部22，以及连接第一顶部21和第一底部22的第一侧部23，第一顶部21位于第一表面12；通过使第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐增大或逐渐减小，提高第一接头20的容纳体积和表面积，使得第一接头20能容纳、附 着更多粘合剂，进而提高医疗器械组件的连接强度。其次，通过使第一接头20在厚度方向的截面尺寸沿远离第一表面12的方向逐渐增大或逐渐减小，使得医疗器械组件受到沿轴向的拉力时，第一接头20对粘合剂的作用力抵消一部分粘合剂受到的轴向拉力，使得第一接头20处的粘合剂受到的轴向拉力比实际轴向拉力小，进一步提高医疗器械组件的连接强度。
在一些可选的实施例中，第一接头20沿厚度方向下沉于第一表面12，即第一接头20为第一表面12上的凹槽，第一底部22和第一侧部23下沉于第一表面12，第一底部22为凹槽的底面，第一顶部21为第一接头20位于第一表面12上的开口。此时，第一接头20为沿厚度方向x下沉于第一表面12的缺口。
可选的，第一接头20在厚度方向x上沿远离第一表面12的方向逐渐增大。
本实施例提供的医疗器械组件10，通过下沉于第一表面12的第一接头20及第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐增大，使得第一侧部23与第一底部22之间形成一个向第一接头20内部凹陷的容置槽24，当采用胶接方式连接医疗器械组件时，粘合剂由于容置槽24的存在不易从本体11脱离，进而提高医疗器械组件10的连接强度。请参考图4至图6，图4示出第二示例的医疗器械组件的正视结构示意图；图5示出图4中的医疗器械组件在B-B截面的剖视图；图6示出图5中的医疗器械组件在N位置的局部放大图。
如图4至图6所示，在一些可选的实施例中，第一接头20沿厚度方向x凸起于第一表面12，即第一接头20为第一表面12上的凸起，第一顶部21位于第一表面12，第一底部22和第一侧部23凸起于第一表面12，第一底部22为凸起的顶面。
可选的，第一接头20在厚度方向x上沿远离第一表面12的方向逐渐增大。
本实施例提供的医疗器械组件10，通过凸起于第一表面12的第一接头20及第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐增大，使得第一侧部23与第一表面12之间形成一个向第一接头20内部凹陷的容置槽24，当采用胶接方式连接医疗器械组件时，粘合剂由于容置槽24的存在不易从本体11脱离，进而提高医疗器械组件10的连接强度。
在一些可选的实施例中，第一底部22与第一顶部21之间的间距在5μm-350μm的范围内，使得第一接头20的尺寸与微型连接件的微型结构相匹配。当第一接头20为凸起时，第一底部22与第一顶部21之间的间距为凸起的高度，当第一接头20为凹槽时， 第一底部22与第一顶部21之间的间距为凹槽的深度。
在一些可选的实施例中，第一侧部23与第一表面12之间的夹角在0.5°-60°的范围内，即至少一个第一侧部23与第一表面12之间的夹角为锐角。
本实施例提供的医疗器械组件10，通过设置第一侧部23与第一底部22之间的夹角在0.5°-60°的范围内，第一侧部23与第一底部22之间过大的夹角将会减小容置槽24的体积，进而减小容置槽24内能容纳粘合剂的量，影响医疗器械组件10的连接强度。同时，第一侧部23与第一表面12之间过大的夹角还会提高第一接头20的制备难度。
在一些可选的实施例中，第一接头20通过飞秒激光工艺制备，通过控制激光束的入射角进而控制第一侧部23与第一表面12之间的夹角以及第一接头20的形状。
当第一接头20为凸起时，激光束将第一表面12上除第一接头20之外的区域均除去一定厚度，使整个第一表面12下沉，进而使第一接头20凸出于第一表面12。当第一接头20为凹槽时，激光束将第一表面12上第一接头20的区域除去一定厚度，使第一接头20下沉于第一表面12。
本实施例提供的医疗器械组件10，通过飞秒激光工艺制备第一接头20，飞秒激光工艺中的极短脉冲激光可直接将材料从固态转化为气态，材料蒸发后没有热熔区，进而使医疗器械组件10上无化学污染。
请参考图2和图7，图7示出另一种示例的图1中的医疗器械组件在A-A截面的剖视图。
在一些可选的实施例中，沿第一接头20的延伸方向，第一接头20的横截面形状可以为多边形中的一种或多种。当第一接头20在延伸方向上的横截面形状为四边形时，即第一底部22的两侧分别与两个第一侧部23相连，两个第一侧部23可以均与第一表面12之间形成锐角(如图2所示)。也可以一个第一侧部23与第一表面12之间形成锐角，另一个第一侧部23与第一表面12垂直(如图7所示)。
请参考图8至图10，图8示出第三示例的医疗器械组件的正视结构示意图；图9示出图8中的医疗器械组件在C-C截面的剖视图；图10示出图8中的医疗器械组件在D-D截面的剖视图。
在一些可选的实施例中，第一接头20在厚度方向x上的横截面形状为多边形(如图8至图10所示)、半圆形、半椭圆形中的一种或多种。
可选的，第一接头20在厚度方向x上的横截面形状为等腰三角形或正三角形。
在一些可选的实施例中，本体11呈圆管状，第一表面12为圆管的外表面或内表面。
可选的，本体11的内径为1-10mm，壁厚为0.1-0.5mm。本体11的优选内径为2-6mm，优选壁厚为0.1-0.3mm。
请参考图11和图12，图11示出另一种示例的医疗器械组件的正视结构示意图；图12示出一种示例的图11中的医疗器械组件在E-E截面的剖视图。
如图11和图12所示，在一些可选的实施例中，第一接头20为多个，各第一接头20沿本体11的周向分布本体11。
在一些可选的实施例中，多个第一接头20等间距的设置在第一表面，进一步提高医疗器械组件的连接强度。每一个第一接头20中第一侧部23的数量可以为一个或复数个，第一接头20中第一侧部23的数量与第一接头20在厚度方向x上的横截面形状有关。当第一接头20在厚度方向x上的横截面形状为圆形或椭圆形时，第一接头20中第一侧部23的数量为1个。当第一接头20在厚度方向x上的横截面形状为多边形时，第一接头20中第一侧部23的数量与多边形的边数相同。
请参考图13和图14，图13示出第五示例的医疗器械组件的正视结构示意图；图14示出图13中的医疗器械组件在F-F截面的剖视图。
如图13和图14所示，在一些可选的实施例中，医疗器械组件10也可以为平板状。
在一些可选的实施例中，第一接头20沿厚度方向x下沉于第一表面12，第一接头20用于放置药物30和/或粘合剂50，药物30、粘合剂50放置于第一底部22和第一侧部23之间形成的容置槽24。可选的，第一接头20用于放置药物30和/或粘合剂50指的是第一接头20可以放置药物30、粘合物50中的一种，也可以放置药物30和粘合物50的组合物。
请参考15和图16，图15示出一种实施例的医疗器械组件和药物的正视结构示意图；图16示出图15中的医疗器械组件和药物在G-G截面的剖视图。
如图15和图16所示，第一接头20沿厚度方向x下沉于第一表面12，第一接头20用于放置药物30。
临床上为实现特定功能目的，需要在置入用户体内的医疗器械表面添加特定的药物30，而目前的支架通常以球囊扩张支架为主，如果使用记忆合金为平台，则需要以 鞘管的方式进行输送，支架外表面将与鞘管内表面发生摩擦，容易导致药物30脱落。
本实施例提供的医疗器械组件10，通过下沉于第一表面12的第一接头20及第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐增大，使得第一侧部23与第一底部22之间形成一个向第一接头20内部凹陷的容置槽24，药物30可容纳于凹陷的第一接头20内，内陷的容置槽24提高药物30与医疗器械组件10的连接强度，降低药物30从医疗器械组件10上脱落的概率。
可选的，当第一接头20凸起于第一表面12时，第一接头20可以用于附着药物30和/或粘合剂50，药物30、粘合剂50附着于第一底部22和/或第一侧部23的表面。
可选的，第一接头20用于附着药物30和/或粘合剂50指的是第一接头20可以附着药物30、粘合物50中的一种，也可以附着药物30和粘合物50的组合物。
可选的，当第一接头20凸起于第一表面12且第一接头20在厚度方向x的截面尺寸沿远离第一表面的方向逐渐增大时，药物30、粘合剂50还可以放置于第一底部22和第一侧部23之间形成的容置槽24。
请参考图20至图22，图20示出第六示例的医疗器械组件的剖视图；图21示出第七示例的医疗器械组件的剖视图；图22示出第八示例的医疗器械组件的剖视图在一些可选的实施例中，第一接头20在厚度方向x上的截面尺寸沿远离第一表面12的方向逐渐减小。
可选的，如图20和图21所示，第一接头20沿厚度方向x下沉于第一表面12，此时，药物30、粘合剂50放置于第一接头20内。
可选的，如图22所示，第一接头20沿厚度方向x凸起于第一表面12，此时，药物30、粘合剂50附着于第一底部22和/或第一侧部23的表面。
可选的，第一接头20在垂直厚度方向x上的截面形状为等腰三角形、正三角形、半圆形、半椭圆形中的至少一种。
本申请提供的医疗器械组件，通过使第一接头20在厚度方向x上的尺寸规律变化，提高第一接头20间的尺寸均一性，进而提高医疗器械组件的连接强度。请参考图17至图19，在另一些可选的实施例中，本申请还提供一种医疗器械组件，包括本体11、目标物件40和填充物，本体11与目标物件40连接，填充物位于本体11和目标物件40之间，填充物包括药物和/或粘合剂，本体11包括朝向目标物件40的第一表面12和设置于第一表面12的至少一个第一接头20。第一接头20包括第一顶部21、第一底部22 和连接第一顶部21、第一底部22的第一侧部23。第一顶部21位于第一表面12，第一底部22和第一顶部21沿本体11的厚度方向x间隔设置，第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐增大或逐渐减小，至少部分填充物位于第一接头20内或附着在第一接头20的表面。
可选的，填充物包括药物30和/或粘合剂50指的是填充物可以为药物30、粘合物50中的一种，也可以为药物30和粘合物50的组合物。
请参考图17和图18，图17为本申请一些实施例的医疗器械组件、目标部件和粘合剂的正视结构示意图；图18示出图17中的医疗器械组件、目标部件和粘合剂在H-H截面的剖视图。
如图17和图18所示，本申请还提供一种医疗器械组件10的连接方法，用于连接如上所述的医疗器械组件10和目标部件40，其中医疗器械组件10与目标部件40的其中一个由金属支撑，另一个由高分子材料制成。连接方法包括：
步骤S1，在第一表面12上涂覆粘合剂50，至少部分粘合剂50覆盖第一接头20；步骤S2，将目标部件40的第二表面41朝向第一表面12，向目标部件40和医疗器械组件10加压与加热，使粘合剂50热熔并附着在目标部件40和医疗器械组件10之间；
步骤S3，将医疗器械组件10与目标部件40冷却，使医疗器械组件10与目标部件40通过粘合剂50连接一体。
可选的，当医疗器械组件10、目标部件40均为平板状时，步骤S2中，第一表面12朝向第二表面41。当医疗器械组件10、目标部件40均为圆管状时，步骤S2中，目标部件40套设在医疗器械组件10的外表面，此时第一表面12为医疗器械组件10的外表面。或者，医疗器械组件10套设在目标部件40的外表面，此时第一表面12为医疗器械组件10的内表面。
可选的，步骤S1中，当第一接头20为第一表面12上的凹槽时，粘合剂50覆盖第一接头20直至填满第一接头20至粘合剂50的上表面与第一顶部21齐平或从第一顶部21伸出第一接头20。当第一接头20为第一表面12上的凸起时，粘合剂50覆盖第一接头20，且第一底部22上、第一侧部23与第一表面12之间形成的容置槽24内均应覆盖有粘合剂50，第一底部22上的粘合剂50与容置槽24内的粘合剂50连通。
本实施例提供的医疗器械组件10的连接方法，通过第一接头20及涂敷在第一接头20上的粘合剂50，第一接头20上的容置槽24提高粘合剂50与医疗器械组件10的连 接强度，降低不同材料之间采用胶接工艺连接出现连接失效的风险。
在一些可选的实施例中，粘合剂50为热塑性聚安酯(TPU)、可熔性聚四氟乙烯(PFA)中的至少一种。
在一些可选的实施例中，粘合剂50与目标部件40的材质相同。
当目标部件40与医疗器械组件10共同加热加压时，粘合剂50与目标部件40同步热熔，而之后目标部件40与医疗器械组件10冷却后，粘合剂50与目标部件40经再成型后成为一体，此时目标部件40由于第一接头20的存在，而与医疗器械组件10连接稳固。
请参考图19，图19示出另一种示例的图17中的医疗器械组件、目标部件和粘合剂在H-H截面的剖视图。
如图19所示，在一些可选的实施例中，第二表面41上还设有第二接头42，第二接头42为第二表面41上的凸起或凹槽。当第一接头20为凸起时，第二接头42为凹槽，当医疗器械组件10与目标部件40连接时，第一接头20伸入第二接头42内，粘合剂50填充在第一接头20与第二接头42之间。当第一接头20为凹槽时，第二接头42为凸起，当医疗器械组件10与目标部件40连接时，第二接头42伸入第一接头20内，粘合剂50填充在第一接头20与第二接头42之间。
本实施例提供的医疗器械组件10的连接方法，通过第一接头20和第二接头42，提高粘合剂50与医疗器械组件10、目标部件40的接触面积，进而提高医疗器械组件10与目标部件40的连接强度。
本实施例提供的医疗器械组件10，包括本体11和本体11上的第一表面12与第一接头20，第一接头20包括沿厚度方向x间隔设置的第一顶部21和第一底部22，以及连接第一顶部21和第一底部22的第一侧部23，第一顶部21位于第一表面12；通过使第一接头20在厚度方向x的截面尺寸沿远离第一表面12的方向逐渐增大，使得第一侧部23形成一个向第一接头20内部凹陷的容置槽24，当采用胶接方式连接医疗器械组件时，粘合剂50由于容置槽24的存在不易从本体11脱离，进而提高医疗器械组件10的连接强度。
以上所述，仅为本申请的具体实施方式，所属领域的技术人员可以清楚地了解到，为了描述的方便和简洁，上述描述的系统、模块和单元的具体工作过程，可以参考前述方法实施例中的对应过程，在此不再赘述。应理解，本申请的保护范围并不局限于 此，任何熟悉本技术领域的技术人员在本申请揭露的技术范围内，可轻易想到各种等效的修改或替换，这些修改或替换都应涵盖在本申请的保护范围之内。

Claims (19)

  1. 一种医疗器械组件，其中，包括本体，所述本体包括第一表面和设置于所述第一表面的至少一个第一接头，所述第一接头包括第一顶部、第一底部和连接所述第一顶部、所述第一底部的第一侧部，所述第一顶部位于所述第一表面，所述第一底部和所述第一顶部沿所述本体的厚度方向间隔设置，所述第一接头在所述厚度方向的截面尺寸沿远离所述第一表面的方向逐渐增大或逐渐减小。
  2. 根据权利要求1所述的医疗器械组件，其中，所述第一接头沿所述厚度方向下沉于所述第一表面，所述第一顶部为位于所述第一表面的开口。
  3. 根据权利要求2所述的医疗器械组件，其中，所述第一接头至少部分用于放置药物和/或粘合剂。
  4. 根据权利要求3所述的医疗器械组件，其中，所述药物、所述粘合剂放置于所述第一底部和所述第一侧部之间。
  5. 根据权利要求1所述的医疗器械组件，其中，所述第一接头沿所述厚度方向凸起于所述第一表面。
  6. 根据权利要求5所述的医疗器械组件，其中，所述第一接头至少部分表面用于附着药物和/或粘合剂。
  7. 根据权利要求6所述的医疗器械组件，其中，所述药物、所述粘合剂附着于所述第一底部和/或所述第一侧部。
  8. 根据权利要求1所述的医疗器械组件，其中，所述本体呈圆管状，所述第一表面为圆管的外表面或内表面。
  9. 根据权利要求8所述的医疗器械组件，其中，所述本体的内径为1-10mm，所述本体的壁厚为0.1-0.5mm。
  10. 根据权利要求8所述的医疗器械组件，其中，所述第一接头为多个，各所述第一接头沿所述本体的周向分布。
  11. 根据权利要求8所述的医疗器械组件，其中，多个所述第一接头等间距的设置在所述第一表面。
  12. 根据权利要求1所述的医疗器械组件，其中，所述第一底部与所述第一顶部之间的间距在5μm-350μm的范围内。
  13. 根据权利要求1所述的医疗器械组件，其中，所述第一侧部与所述第一底部之间的夹角在0.5°-60°的范围内。
  14. 根据权利要求1所述的医疗器械组件，其中，所述第一接头通过飞秒激光工艺制备。
  15. 根据权利要求1所述的医疗器械组件，其中，所述第一接头在所述厚度方向上的横截面形状为圆形、多边形、半圆形、半椭圆形中的一种或多种。
  16. 一种医疗器械组件，其中，包括本体、目标物件和填充物，所述本体与所述目标物件连接，所述填充物位于所述本体和所述目标物件之间，所述填充物包括药物和/或粘合剂，所述本体包括朝向所述目标物件的第一表面和设置于所述第一表面的至少一个第一接头，所述第一接头包括第一顶部、第一底部和连接所述第一顶部、所述第一底部的第一侧部，所述第一顶部位于所述第一表面，所述第一底部和所述第一顶部沿所述本体的厚度方向间隔设置，所述第一接头在所述厚度方向的截面尺寸沿远离所述第一表面的方向逐渐增大或逐渐减小，至少部分填充物位于所述第一接头内或附着在所述第一接头的表面。
  17. 一种医疗器械组件的连接方法，用于连接如权利要求1至15任一所述的医疗器械组件与目标部件，所述医疗器械组件与所述目标部件的其中一个由金属制成，另一个由高分子材料或塑料制成，其中，所述连接方法包括：
    在所述第一表面上涂覆粘合剂，至少部分所述粘合剂覆盖至少部分所述第一接头；
    将所述目标部件的连接部与所述医疗器械组件的第一接头处配合好，向所述目标部件的连接部与所述医疗器械组件的第一接头处加压与加热，使所述粘合剂热熔并附着在所述目标部件与所述医疗器械组件之间；
    将所述医疗器械组件与所述目标部件冷却，使所述医疗器械组件与所述目标部件通过所述粘合剂连接一体。
  18. 根据权利要求17所述的医疗器械组件的连接方法，其中，所述粘合剂为热塑性聚安酯、可熔性聚四氟乙烯中的至少一种。
  19. 根据权利要求17所述的医疗器械组件的连接方法，其中，所述粘合剂与所述目标部件或所述医疗器械组件的材质相同。
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