Implantable temperature measuring assembly and implantable medical device

Abstract

The embodiment of the invention discloses an implantable temperature measurement assembly and an implantable medical device, and a containing groove of a shell part is provided with a heat conduction filling adhesive, so that a sensing head is in full contact with the heat conduction filling adhesive, the temperature measurement precision and timeliness are improved, and after the heat conduction filling adhesive is cured, the connection strength can be improved, and the consistency of an assembly process is ensured. And on the other hand, the first positioning edge is arranged on the outer side of the heat conduction cover body, so that the implantable temperature measurement assembly can be fixed on the shell of the implantable medical equipment by using the first positioning edge, and the reliability of the assembly process is improved by a modular connection mode.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of implantable medical devices, and in particular to an implantable temperature measuring assembly and an implantable medical device. BACKGROUND

[0002] The implantable medical device includes a deep brain stimulator, an implanted brain cortex stimulator, an implanted spinal cord stimulator, an implanted sacral nerve stimulator, an implanted vagus nerve stimulator, an implanted cardiac electric stimulation system (commonly known as a cardiac pacemaker) and an implanted drug infusion system, and the like. In the use of the implantable medical device, the body temperature of the patient or the working temperature of the implantable medical device needs to be detected to ensure safe use.

[0003] Generally, a temperature sensor is arranged in the implantable medical device, and the temperature sensor is spaced from the shell or is pasted on the inner surface of the shell by means of glue or a back adhesive film. These modes are difficult to ensure the detection accuracy of the temperature sensor, resulting in deviation of temperature detection, and the installation and fixation of the temperature sensor are also relatively difficult. How to optimize the installation process of the temperature sensor and improve the temperature detection accuracy becomes a problem to be solved. SUMMARY

[0004] Therefore, the implantable temperature measuring assembly and the implantable medical device are provided, and the heat-conducting filling glue is filled between the accommodating groove and the sensing head, the heat-conducting area of the sensing head is increased, and the assembly process of the implantable temperature measuring assembly and the shell is simplified.

[0005] According to a first aspect of the embodiment of the present application, an implantable temperature measuring assembly for being installed in an implantable medical device is provided, and the implantable temperature measuring assembly comprises:

[0006] heat-conducting filling glue;

[0007] a shell part comprising a heat-conducting cover and a first positioning edge, an outer surface of the heat-conducting cover has a heat-conducting contact surface, an inner surface of the heat-conducting cover has an accommodating groove, the first positioning edge is protruded on the outer surface of the heat-conducting cover, and the heat-conducting contact surface is made of implantable material; and

[0008] a temperature sensor comprising a sensing head, at least part of the sensing head is inserted into the accommodating groove and is arranged to be spaced from the inner wall of the accommodating groove, and the heat-conducting filling glue is filled between the sensing head and the accommodating groove.

[0009] Further, the heat-conducting cover comprises an end side wall and a circumferential side wall, the circumferential side wall is connected with the edge of the end side wall and surrounds the end side wall to form the accommodating groove, and the heat-conducting contact surface is formed on the side of the end side wall away from the accommodating groove;

[0010] The first positioning rim extends along the circumference of the end side wall and protrudes laterally towards the peripheral side wall.

[0011] Further, the end side wall is curved towards a side away from the accommodating groove, and the first positioning rim has a first positioning surface for connecting and positioning with the implantable medical device.

[0012] Further, the lateral side of the end side wall has a relief annular surface facing the lateral side of the end side wall, and the relief annular surface is located between the heat-conducting contact surface and the first positioning rim.

[0013] Further, the temperature sensor further comprises a lead wire connected with the sensing head;

[0014] The implantable temperature measuring assembly further comprises a cover plate having a relief hole;

[0015] The cover plate covers the accommodating groove and is adhered with the heat-conducting filling glue, and the lead wire protrudes from the relief hole.

[0016] According to a second aspect of the embodiments of the present application, an implantable medical device is provided, comprising:

[0017] a main body part comprising a housing and a circuit board arranged in the housing, the housing having a connecting hole; and

[0018] an implantable temperature measuring assembly comprising heat-conducting filling glue, a shell part and a temperature sensor, the shell part comprising a heat-conducting cover and a first positioning rim, an outer surface of the heat-conducting cover having a heat-conducting contact surface, the heat-conducting cover having an accommodating groove inside, the first positioning rim being protruded from the outer surface of the heat-conducting cover, the heat-conducting contact surface being made of implantable material, the temperature sensor comprising a sensing head, at least part of the sensing head being inserted into the accommodating groove and being arranged in a spaced manner with the accommodating groove, the sensing head being electrically connected with the circuit board, and the heat-conducting filling glue being filled between the sensing head and the accommodating groove;

[0019] The heat-conducting cover is arranged in the connecting hole, the heat-conducting contact surface is exposed to the outside of the housing, and the first positioning rim abuts against the hole rim of the connecting hole.

[0020] Further, the heat-conducting cover comprises an end side wall and a peripheral side wall, the peripheral side wall is connected with the edge of the end side wall and forms the accommodating groove around the end side wall, the heat-conducting contact surface is formed on a side of the end side wall away from the accommodating groove, and the first positioning rim extends along the circumference of the end side wall and protrudes laterally towards the peripheral side wall.

[0021] The first positioning rim has a first positioning surface, and the first positioning surface is fixedly connected with the hole rim of the connecting hole.

[0022] Further, the first positioning surface is opposite to the heat-conducting contact surface.

[0023] The side wall of the shell comprises a recessed area recessed to the inner side of the shell and forming a groove, the recessed area has the connecting hole, the first positioning surface is sealingly connected with the outer side surface of the shell, and the end side wall is located in the groove.

[0024] Further, the lateral side of the end side wall has a relief annular surface, the first positioning edge is protruded on the lateral side of the end side wall, the first positioning surface is sealingly connected with the inner side surface of the shell, one side of the relief annular surface is connected with the first positioning edge, and the other side passes through the connecting hole and is connected with the heat-conducting contact surface.

[0025] Further, the implantable medical device further comprises:

[0026] An electric energy receiving coil electrically connected with the circuit board;

[0027] The circuit board is configured to collect a temperature signal through the implantable temperature measuring assembly in response to the electric energy receiving coil receiving electric energy, and the circuit board is further configured to control to stop receiving electric energy in response to the temperature signal being greater than or equal to a first threshold value, and to control to receive electric energy in response to the temperature signal being less than a second threshold value.

[0028] The beneficial effects of the present application are:

[0029] In the present application, the temperature measuring assembly is used to be installed in the implantable medical device, the sensing head is arranged in the accommodating groove of the shell part, the accommodating groove is filled with the heat-conducting filling glue, the sensing head does not directly contact with the shell, and the heat-conducting contact surface of the shell part is used to contact with the body tissue. Compared with the existing temperature sensor directly placed in the device shell or fixed by a small amount of glue and the inner wall of the shell, the present application improves the temperature measuring precision and timeliness. After the heat-conducting filling glue is solidified, the connection strength is also improved, and the assembly process consistency is ensured. The first positioning edge is arranged on the outer side of the heat-conducting cover body, so as to fix the implantable temperature measuring assembly on the shell of the implantable medical device by using the first positioning edge. This modular temperature measuring assembly is convenient to install, and the assembly process reliability is improved.

[0030] In the wireless charging process of the implantable medical device in the body, the temperature rise of the battery can cause the temperature rise of the human tissue around the device. The temperature measuring assembly of the present application is installed in the shell of the implantable medical device, directly contacts with the human tissue by using the implantable heat-conducting contact surface for temperature detection, improves the timeliness and accuracy of temperature collection, solves the problem that the existing device cannot collect the temperature of the human tissue in time and directly, delays, causes the temperature to temporarily exceed the safety threshold, and causes the problem of low-temperature scald of the human tissue. BRIEF DESCRIPTION OF DRAWINGS

[0031] The above and other objects, features and advantages of the present application will become more apparent from the following description of embodiments of the present application taken in conjunction with the accompanying drawings, in which:

[0032] Figure 1 is a sectional view of an implantable temperature measuring assembly provided by the first embodiment of the present application;

[0033] Figure 2 is a structural view of a shell provided by the first embodiment of the present application;

[0034] Figure 3 is a sectional view of the shell provided by the first embodiment of the present application;

[0035] Figure 4 is a structural view of a shell provided by the second embodiment of the present application;

[0036] Figure 5 is a sectional view of the shell provided by the second embodiment of the present application;

[0037] Figure 6 is a structural view of a shell provided by the third embodiment of the present application;

[0038] Figure 7 is a sectional view of the shell provided by the third embodiment of the present application;

[0039] Figure 8 is a sectional view of an implantable medical device provided by the fourth embodiment of the present application;

[0040] Figure 9 is a sectional view of an implantable medical device provided by the fifth embodiment of the present application;

[0041] Figure 10 is a sectional view of an implantable medical device provided by the sixth embodiment of the present application.

[0042] BRIEF DESCRIPTION OF DRAWINGS

[0043] 1 - temperature sensor;

[0044] 11 - sensing head; 12 - lead wire;

[0045] 2a, 2b, 2c - shell;

[0046] 21, 21 a - thermally conductive cover; 211, 211 a - thermally conductive contact surface; 212 - accommodating groove; 2121 - first accommodating chamber; 2122 - second accommodating chamber;

[0047] 22 - first positioning rim; 23, 23a - end side wall; 24, 24a - peripheral side wall; 25 - first positioning face; 26 - relief annulus; 27 - second positioning rim; 28 - positioning gap; 29, 29a - cover plate; 291 - relief hole;

[0048] 3 - thermally conductive filling glue; 4 - main body;

[0049] 41, 41a, 41b - housing; 411 - connecting hole; 412 - recessed area; 413 - groove;

[0050] 42 - circuit board;

[0051] 7 - skin;

[0052] 81 - substrate; 82 - flexible circuit board; 83 - second connector. DETAILED DESCRIPTION

[0053] The present application is described in detail below based on examples, but the present application is not limited to only these examples. In the following detailed description of the present application, some specific details are described in detail. The present application can also be fully understood without the description of these details by those skilled in the art. In order to avoid confusion of the essence of the present application, well-known methods, processes, procedures, elements and circuits are not described in detail.

[0054] In addition, those of ordinary skill in the art will understand that the drawings provided herein are for illustrative purposes only and are not necessarily drawn to scale.

[0055] Unless the context clearly requires otherwise, throughout the description, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in the sense of "including, but not limited to".

[0056] In the description of the present application, it should be understood that the terms "first", "second", etc. are only for the purpose of description and cannot be understood as indicating or implying relative importance. In addition, in the description of the present application, unless otherwise specified, the meaning of "multiple" is two or more.

[0057] Unless otherwise expressly specified and limited, the terms "mounting", "connecting", "connecting", "fixing" and the like should be interpreted in a broad sense, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be directly connected, or it can be indirectly connected through an intermediate medium; it can be the internal communication of two elements or the interaction relationship between two elements, unless otherwise expressly limited. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0058] For ease of description, spatially relative terms, such as "inner," "outer," "beneath," "below," "lower," "above," "upper," and the like, can be used herein for the purpose of illustrating one element or feature's relationship to another element or feature within a figure. It will be understood that spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if a device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" the other elements or features. Thus, the example term "below" can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0059] First embodiment:

[0060] Figure 1 is a cross-sectional view of the implantable temperature measurement assembly provided by the first embodiment of the present application.

[0061] Figure 2 is a structural view of the shell portion 2a provided by the first embodiment of the present application. Figure 3 is a cross-sectional view of the shell portion 2a provided by the first embodiment of the present application.

[0062] As shown in Figure 1 the implantable temperature measurement assembly in the present embodiment includes a temperature sensor 1, a shell portion 2a, and a thermally conductive filling glue 3. The temperature sensor 1 is a contact temperature sensor, including but not limited to a thermocouple sensor or a thermistor sensor, etc. Taking the thermistor sensor as an example, the temperature sensor 1 can be an NTC (Negative Temperature Coefficient) sensor. Specifically, the NTC sensor can be a patch type NTC or a lead type NTC, the patch type NTC is welded after pin hole, and the lead type NTC is connected with the circuit board by lead 12.

[0063] Referring to Figures 1-3As shown, the shell part 2a includes a heat-conductive cover 21 and a first positioning rim 22, the outer surface of the heat-conductive cover 21 has a heat-conductive contact surface 211, the heat-conductive cover 21 has a receiving groove 212 inside, and the first positioning rim 22 is protruded on the outer surface of the heat-conductive cover 21. The heat-conductive contact surface 211 is configured to be a material of implantable grade and in contact with the tissue in vivo. The material of the shell part 2a can be titanium metal, titanium alloy, non-magnetic nickel-cobalt-chromium-molybdenum alloy (MP35N), or implantable grade stainless steel, etc. The temperature sensor 1 includes a sensing head 11, at least part of the sensing head 11 is inserted into the receiving groove 212 and is spaced apart from the inner wall of the receiving groove 212, and the heat-conductive filling glue 3 is filled between the sensing head 11 and the receiving groove 212. For example, two-thirds of the area of the surface of the sensing head 11 is ensured to enter the receiving groove 212 and be bonded with the heat-conductive filling glue 3. The material of the heat-conductive filling glue 3 includes but is not limited to epoxy resin, acrylic, or silicone rubber, etc.

[0064] In the embodiment of the present application, the heat-conductive filling glue 3 can be degassed before being filled, and the filling is performed in a vacuum environment to reduce bubbles and ensure the heat conduction efficiency of the heat-conductive filling glue 3. The sensing head 11 is located at the central position of the receiving groove 212 and does not contact the shell part in each direction, and the maximum distance of the sensing head 11 from the inner wall of the receiving groove 212 in each direction is not more than 2 mm, which improves the detection accuracy and timeliness and reduces the detection deviation. Preferably, the maximum distance of the sensing head 11 from the inner wall of the receiving groove 212 in each direction is not more than 1 mm, and the distance of the sensing head 11 from the inner wall of the receiving groove 212 in the direction towards the heat-conductive contact surface 211 is less than the distance in other directions, which improves the heat transfer effect from the heat-conductive contact surface 211 to the sensing head 11.

[0065] As shown in Figures 2-3 The heat-conductive cover 21 includes an end side wall 23 and a circumferential side wall 24, the circumferential side wall 24 is connected with the edge of the end side wall 23 and forms the receiving groove 212 around the end side wall 23, and the heat-conductive contact surface 211 is formed on the side of the end side wall 23 away from the receiving groove 212. One end of the circumferential side wall 24 away from the end side wall 23 forms an opening, and the heat-conductive filling glue 3 and the sensing head 11 can enter the receiving groove 212 from the opening. The first positioning rim 22 extends along the circumference of the end side wall 23 and protrudes laterally towards the circumferential side wall 24. The sensing head 11 is spaced apart from the end side wall 23 and the circumferential side wall 24.

[0066] Preferably, the end side wall 23 is in a cylindrical structure. In the axial cross-sectional direction of the circumferential side wall 24, the inner surface and the outer surface of the circumferential side wall 24, and the side surface of the first positioning rim 22 are all cylindrical surfaces. Thus, it is helpful for the implantable temperature measurement assembly to be assembled with the outer shell 41.

[0067] The implantable temperature measurement assembly according to the present embodiment is used in the temperature measurement device 4 as shown in Figure 8The end side wall 23 is bent to the side away from the accommodating groove 212, the first positioning edge 22 is located outside the shell 41, the first positioning edge 22 has a first positioning surface 25, and the first positioning surface 25 is in sealing connection with the inner wall of the shell 41. Specifically, the first positioning surface 25 is a circular ring plane, the shell part 2a is positioned and assembled with the shell 41 by using the circular ring plane, and the length of the temperature measuring assembly extending into the shell 41 is limited by the first positioning surface 25. Bending the end side wall 23 to the side of the human tissue can increase the contact area of the heat conduction contact surface 211 with the human body, improve the accuracy and timeliness of temperature detection, and reduce the friction of the curved heat conduction contact surface 211 with the human tissue.

[0068] Further, as Figure 1 , the temperature sensor 1 further comprises a plurality of lead wires 12 connected with the sensing head 11. The implantable temperature measuring assembly further comprises a cover plate 29 having a plurality of avoiding holes 291. The cover plate 29 is arranged on the accommodating groove 212 and is bonded with the heat conduction filling glue 3, and the plurality of lead wires 12 correspondingly extend from the plurality of avoiding holes 291. In the embodiment, the sensing head 11 completely enters the accommodating groove 212, and the cover plate 29 can be bonded by the heat conduction filling glue 3. As Figure 3 , the dashed part is another structure of the cover plate 29a, the cover plate 29a is larger than the opening of the accommodating groove 212, and the cover plate 29a is fixedly connected with the end of the peripheral side wall 24 by welding. Compared with the existing sensor which is fixed by a small amount of glue, the combination of the heat conduction cover 21, the heat conduction filling glue 3 and the cover plate 29, 29a can improve the reliability of the sensing head 11, which is determined by the service life of the glue.

[0069] Second embodiment:

[0070] Figure 4 is a structure diagram of the shell part 2b provided by the second embodiment of the present application. Figure 5 is a cross-sectional view of the shell part 2b provided by the second embodiment of the present application.

[0071] As Figures 4-5 shown, the difference between the second embodiment and the first embodiment mainly lies in that the end side wall 23 has an avoiding ring surface 26 in the lateral direction, and the avoiding ring surface 26 is located between the heat conduction contact surface 211 and the first positioning edge 22.

[0072] Specifically, the first positioning edge 22 is protruded on the edge of the peripheral side wall 24 close to the end side wall 23, so that the edge of the end side wall 23 forms the avoiding ring surface 26. Referring to the implantable temperature measuring assembly in the Figure 10The implantable temperature sensing assembly in the embodiment can be assembled from the inner side of the shell 41b, that is, the first positioning rim 22 is arranged on the inner side of the shell 41b. The avoidance annular surface 26 is used to cooperate with the connecting hole 411 on the shell 41b to position the shell part 2b and the shell 41b, and meanwhile ensure that the heat conduction contact surface 211 can be exposed to the outer side of the shell 41b through the connecting hole 411.

[0073] Figure 6 is a structural schematic view of the shell part 2c provided by the third embodiment of the present application. Figure 7 is a sectional view of the shell part 2c provided by the third embodiment of the present application, Figure 7 the dashed line is an installation schematic view of the sensing head 11.

[0074] Third embodiment:

[0075] As shown in Figures 6-7 , the heat conduction cover 21a includes an end side wall 23a and a circumferential side wall 24a, and the first positioning rim 22 is protruded on the end side wall 23a. The heat conduction contact surface 211a of the end side wall 23a is arranged on the inner side of the end side wall 23a. Figures 1-5 Compared with the curved surface, the heat conduction contact surface 211a can be arranged as a flat surface structure in other embodiments. Figures 6-7 The circumferential side wall 24a is further provided with a second positioning rim 27, the second positioning rim 27 is arranged in a spaced manner with the first positioning rim 22, and the opposite sides of the second positioning rim 27 and the first positioning rim 22 form a positioning gap 28 with the circumferential side wall 24a. The shell part 2c in the embodiment can be clamped on the shell of the implantable medical device through the positioning gap 28, and laser welding is performed on the inner and outer sides of the shell, thereby improving the air tightness of the shell.

[0076] Further, the accommodating groove 212a includes a first accommodating chamber 2121 and a second accommodating chamber 2122 in the depth direction, and the first accommodating chamber 2121 is located between the heat conduction contact surface 211a and the second accommodating chamber 2122. In the sectional direction of the depth of the accommodating groove 212a, the inner diameter of the second accommodating chamber 2122 is greater than that of the first accommodating chamber 2121, and the sensing head 11 is at least partially located in the first accommodating chamber 2121. By using the second accommodating chamber 2122, the volume of the accommodating groove 212a can be increased, thereby improving the fixing effect of the heat conduction filling glue 3 on the sensing head 11.

[0077] Fourth embodiment:

[0078] Figure 8 is a sectional view of the implantable medical device provided by the fourth embodiment of the present application.

[0079] In the embodiment, the implantable temperature sensing assembly of the first embodiment is arranged on the shell 41, as shown in Figure 8As shown, the implantable medical device in the embodiment includes an implantable temperature measuring assembly, a main body 4. The main body 4 includes a housing 41 and a circuit board 42 arranged in the housing 41, the housing 41 has a connecting hole 411. The implantable temperature measuring assembly includes a thermally conductive filling glue 3, a shell 2a and a temperature sensor 1. The shell 2a includes a thermally conductive cover 21 and a first positioning rim 22, the outer surface of the thermally conductive cover 21 has a thermally conductive contact surface 211, the inner surface of the thermally conductive cover 21 has a receiving groove 212, and the first positioning rim 22 is protruded from the outer surface of the thermally conductive cover 21. The thermally conductive contact surface 211 is configured to be a material of implantable grade and is in contact with the tissue in the body. The temperature sensor 1 includes a sensing head 11, at least part of the sensing head 11 extends into the receiving groove 212 and is arranged in a spaced manner with the receiving groove 212, and the thermally conductive filling glue 3 is filled between the sensing head 11 and the receiving groove 212. The thermally conductive cover 21 is arranged in the connecting hole 411, the thermally conductive contact surface 211 is exposed to the outside of the housing 41, and the first positioning rim 22 is laser welded with the hole rim of the connecting hole 411.

[0080] In the embodiment, the implantable medical device is implanted in the human body, and then the temperature of the human body is detected in real time by the implantable temperature measuring assembly. When the thermally conductive contact surface 211 is arranged towards the skin 7, the thermally conductive contact surface 211 can also detect the temperature of the wound position of the skin 7, so as to indirectly judge whether the wound is infected.

[0081] Further, the thermally conductive cover 21 includes an end side wall 23 and a circumferential side wall 24, the circumferential side wall 24 is connected with the edge of the end side wall 23 and forms the receiving groove 212 around the end side wall 23. The thermally conductive contact surface 211 is formed on the side of the end side wall 23 away from the receiving groove 212, and the first positioning rim 22 extends along the circumference of the end side wall 23 and protrudes laterally to the circumferential side wall 24. The first positioning rim 22 has a first positioning surface 25, the first positioning rim 22 is arranged on the outside of the housing 41, and the thermally conductive contact surface 211 protrudes from the housing 41. The first positioning rim 22 is located at a position away from the opening of the circumferential side wall 24, so as to reduce the protruding height of the thermally conductive cover 21 relative to the housing 41.

[0082] As Figure 8As shown, the shell 41 includes a first shell and a second shell, and the first shell is provided with a connecting hole 411. The temperature sensor 1 is arranged in the connecting hole 411 from the outside of the first shell, and the first positioning surface 25 is fixedly connected with the first shell by laser welding. The implantable medical device further includes an electric energy receiving coil. The temperature sensor 1 and the electric energy receiving coil are electrically connected with the circuit board 42. The circuit board 42 is configured to, in response to the electric energy receiving coil receiving electric energy, collect a temperature signal by the implantable temperature measurement assembly. The circuit board 42 is further configured to, in response to the temperature signal being greater than or equal to a first threshold value, control to stop receiving electric energy, and in response to the temperature signal being less than a second threshold value, control to receive electric energy. In this form, the heat of the electric energy receiving coil and the battery in the implantable medical device can be gradually released through the human body tissue. During the process, the circuit board 42 controls to repeatedly execute the above process until the battery is fully charged. Specifically, the first threshold value can be configured as 40℃, 41℃, 42℃ or 43℃. The second threshold value can be configured to be less than the first threshold value, for example, the second threshold value can be 37℃, and the temperature value can be set. Thus, the human body tissue around the implantable medical device is fully cooled.

[0083] It is easy to understand that, in the embodiment, the temperature of the human body tissue is directly collected by using the heat-conducting contact surface 211, which can improve the real-time performance of temperature collection. Compared with the existing temperature sensor arranged in the device shell, spaced from the inner wall of the shell or adhered to the inner wall of the shell by a small amount of glue, the present application improves the timeliness of temperature detection, and solves the problem of low-temperature scalding of human body tissue caused by the short-term exceeding of the safety threshold value due to poor timeliness.

[0084] Fifth embodiment:

[0085] Figure 9 is a cross-sectional view of the implantable medical device provided by the fifth embodiment of the present application.

[0086] In the embodiment, the implantable temperature measurement assembly in the first embodiment is arranged in the shell 41a, as shown in 9. The main difference between the fifth embodiment and the fourth embodiment is that the side wall of the shell 41a includes a recessed area 412, the recessed area 412 is recessed towards the inside of the shell 41a and forms a groove 413, and the recessed area 412 has a connecting hole 411. The end side wall 23 is located in the groove 413. Thus, the side surface of the implantable medical device is more flat, and the discomfort after implantation is reduced.

[0087] Further, the circuit board 42 in the embodiment is provided with a conductive hole, and the conductive hole is arranged towards the connecting hole 411. The inner wall of the conductive hole is provided with a conductive layer, and the lead wire 12 is welded and fixed through the corresponding conductive hole to realize the electrical connection between the circuit board 42 and the temperature sensor 1.

[0088] Sixth embodiment:

[0089] Figure 10 is a cross-sectional view of the implantable medical device provided by the sixth embodiment of the present application.

[0090] In this embodiment, the implantable temperature measurement assembly in the second embodiment is arranged in the shell 41b. As shown, the sixth embodiment is mainly different from the fourth embodiment in that the first positioning rim 22 is arranged on the inner side of the shell 41b, the first positioning rim 22 is located on the inner side of the shell 41b, the first positioning surface 25 is sealingly connected to the inner side of the shell 41b, and the heat-conducting contact surface 211 is substantially flush with the shell 41b. The end-side wall 23 has a relief annular surface 26 which cooperates with the connecting hole 411. Figure 10

[0091] In this embodiment, the implantable temperature measurement assembly in the second embodiment is arranged in the main body 4. The implantable temperature measurement assembly is arranged from the inner side of the first shell into the connecting hole 411, so that the heat-conducting contact surface 211 is exposed to the outside of the connecting hole 411. The first positioning surface 25 can be fixed to the first shell by welding. In this form, the periphery of the connecting hole 411 can be arranged as a flat surface, without the need to separately arrange the groove 413 in the fifth embodiment, so as to simplify the machining process of the shell 41b.

[0092] Further, the implantable medical device further comprises a connecting assembly, which comprises a substrate 81, a first connector (not shown in the figure), a second connector 83 and a flexible circuit board 82. The substrate 81 is provided with the conductive hole in the fifth embodiment. The first connector can be a flexible connector connected to the conductive hole. The second connector 83 is a board-to-board connector arranged on the circuit board 42, which is electrically connected to one end of the flexible circuit board 82 away from the substrate 81. In this embodiment, the substrate 81 can be connected to the lead 12 first, and then the temperature sensor 1 is fixedly connected to the shell 41b. Finally, the two ends of the flexible circuit board 82 are respectively plugged into the first connector and the second connector.

[0093] The implantable medical device comprises a feedthrough connector and a top cover, and the power receiving coil is arranged in the top cover and electrically connected to the circuit board 42 in the shell through the feedthrough connector. In some other embodiments, the temperature measurement assembly can be integrated on the feedthrough connector. In this design, the timeliness, accuracy and reliability of temperature detection are higher than those of the scheme in which the temperature sensor is spaced from the inner wall of the shell or adhered to the inner wall of the shell by a small amount of glue. However, the heat-conducting contact surfaces 211 and 211a cannot directly contact the human tissue, and the accuracy and timeliness of temperature detection of the human tissue are slightly poor. By setting the first threshold and the second threshold, the temperature of the human tissue around the postoperative wound can be collected, and the temperature of the human tissue around the device during wireless charging can be controlled.

[0094] ​In summary, the implantable medical device in the embodiment utilizes the accommodation groove 212 to accommodate the heat-conducting filling glue 3, so that the sensing head 11 is in full contact with the heat-conducting filling glue 3, and the sensing head 11 is wrapped by the heat-conducting filling glue 3. Compared with the sensor being directly placed in the device shell or being fixedly connected with the inner wall of the shell by a small amount of glue, the application improves the temperature measurement accuracy and timeliness. After the heat-conducting filling glue 3 is solidified, the connection strength is also improved. On the other hand, the heat-conducting contact surface 211 is arranged on the outer surface of the heat-conducting cover 21, and the first positioning edge 22 is arranged on the outer side of the heat-conducting cover 21, so as to facilitate the fixation of the implantable temperature measurement assembly on the connecting hole 411 by the first positioning edge 22. The modular connection mode improves the reliability of the assembly process. On the other hand, when the in-vivo charger charges the implantable medical device, the power receiving coil and the battery will cause the implantable medical device to heat up. If the temperature cannot be detected in time and accurately, the human tissue around the implantable medical device is easy to cause low-temperature scald. The application utilizes the implantable heat-conducting contact surface 211 to directly detect the temperature of the human tissue, so as to improve the real-time performance of temperature acquisition and the accuracy of temperature control.

[0095] The above only describes the preferred embodiments of the application and is not used to limit the application. For those skilled in the art, the application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. within the spirit and principle of the application shall be included in the protection scope of the application.

Claims

1. An implantable temperature sensing component, characterized in that, For installation in implantable medical devices, including: Thermally conductive filler (3); The shell portion (2a, 2b, 2c) includes a heat-conducting cover (21, 21a) and a first positioning edge (22). The outer surface of the heat-conducting cover (21, 21a) has a heat-conducting contact surface (211, 211a), and the inner surface of the heat-conducting cover (21, 21a) has a receiving groove (212). The first positioning edge (22) protrudes from the outer surface of the heat-conducting cover (21, 21a). The heat-conducting contact surface (211, 211a) is made of an implantable material. A temperature sensor (1) includes a sensing head (11), at least a portion of which extends into the receiving groove (212) and is spaced apart from the inner wall of the receiving groove (212), and the thermally conductive filler (3) is filled between the sensing head (11) and the receiving groove (212).

2. The implantable temperature sensing component according to claim 1, characterized in that, The heat-conducting cover (21, 21a) includes end sidewalls (23, 23a) and peripheral sidewalls (24, 24a). The peripheral sidewalls (24, 24a) are connected to the edges of the end sidewalls (23, 23a) and form the receiving groove (212) around the end sidewalls (23, 23a). The heat-conducting contact surfaces (211, 211a) are formed on the side of the end sidewalls (23, 23a) opposite to the receiving groove (212). The first positioning edge (22) extends circumferentially along the end sidewalls (23, 23a) and extends laterally toward the circumferential sidewalls (24, 24a).

3. The implantable temperature sensing component according to claim 2, characterized in that, The end sidewalls (23, 23a) are bent toward the side opposite to the receiving groove (212), and the first positioning edge (22) has a first positioning surface (25) for connection and positioning with an implantable medical device.

4. The implantable temperature sensing component according to claim 3, characterized in that, The end sidewalls (23, 23a) have a clearance annular surface (26) on the side, the clearance annular surface (26) facing the sidewalls (23, 23a) and the clearance annular surface (26) being located between the thermally conductive contact surface (211, 211a) and the first positioning edge (22).

5. The implantable temperature sensing component according to any one of claims 1-4, characterized in that, The temperature sensor (1) also includes a lead wire (12) connected to the sensing head (11); The implantable temperature sensing component also includes a cover plate (29, 29a) having a clearance hole (291); The cover plate (29, 29a) covers the receiving groove (212) and is bonded to the thermally conductive filler (3), and the lead wire (12) extends out from the corresponding clearance hole (291).

6. An implantable medical device, characterized in that, The implantable medical device includes: The main body (4) includes a housing (41, 41a, 41b) and a circuit board (42) disposed within the housing (41, 41a, 41b), the housing (41, 41a, 41b) having a connection hole (411); and An implantable temperature sensing component includes a thermally conductive filler (3), a housing (2a, 2b, 2c), and a temperature sensor (1). The housing (2a, 2b, 2c) includes a thermally conductive cover (21, 21a) and a first positioning edge (22). The outer surface of the thermally conductive cover (21, 21a) has a thermally conductive contact surface (211, 211a), and the inner surface of the thermally conductive cover (21, 21a) has a receiving groove (212). The first positioning edge (22) protrudes from the thermally conductive cover. The outer surface of the heat shield (21, 21a) has the thermally conductive contact surface (211, 211a) made of implantable material. The temperature sensor (1) includes a sensing head (11), at least a portion of which extends into the receiving groove (212) and is spaced apart from the receiving groove (212). The sensing head (11) is electrically connected to the circuit board (42). The thermally conductive filler (3) is filled between the sensing head (11) and the receiving groove (212). The heat-conducting cover (21, 21a) is disposed in the connecting hole (411), the heat-conducting contact surface (211, 211a) is exposed to the outside of the outer shell (41, 41a, 41b), and the first positioning edge (22) abuts against the edge of the connecting hole (411).

7. The implantable medical device according to claim 6, characterized in that, The heat-conducting cover (21, 21a) includes end sidewalls (23, 23a) and peripheral sidewalls (24, 24a). The peripheral sidewalls (24, 24a) are connected to the edges of the end sidewalls (23, 23a) and form the receiving groove (212) around the end sidewalls (23, 23a). The heat-conducting contact surfaces (211, 211a) are formed on the side of the end sidewalls (23, 23a) away from the receiving groove (212). The first positioning edge (22) extends circumferentially along the end sidewalls (23, 23a) and extends laterally toward the peripheral sidewalls (24, 24a). The first positioning edge (22) has a first positioning surface (25), which is fixedly connected to the edge of the connecting hole (411).

8. The implantable medical device according to claim 7, characterized in that, The first positioning surface (25) is opposite to the thermally conductive contact surfaces (211, 211a); The sidewall of the outer shell (41, 41a, 41b) includes a recessed area (412), which is recessed into the inner side of the outer shell (41, 41a, 41b) to form a groove (413). The recessed area (412) has the connecting hole (411). The first positioning surface (25) is sealed to the outer side of the outer shell (41, 41a, 41b), and the end sidewall (23, 23a) is located in the groove (413).

9. The implantable medical device according to claim 7, characterized in that, The end sidewalls (23, 23a) have a clearance annular surface (26) on the side, the first positioning edge (22) protrudes from the sidewalls (23, 23a) on the side, the first positioning surface (25) is sealed to the inner surface of the outer shell (41, 41a, 41b), one side of the clearance annular surface (26) is connected to the first positioning edge (22), and the other side passes through the connecting hole (411) and is connected to the thermally conductive contact surface (211, 211a).

10. The implantable medical device according to claim 6, characterized in that, The implantable medical device also includes: An electrical energy receiving coil is electrically connected to the circuit board (42); The circuit board (42) is configured to receive electrical energy through the implantable temperature measuring component in response to the electrical energy receiving coil receiving electrical energy; the circuit board (42) is also configured to control the cessation of receiving electrical energy in response to the temperature signal being greater than or equal to a first threshold, and to control the receiving of electrical energy in response to the temperature signal being less than a second threshold.

Images