An implantable medical device and manufacturing tooling

Abstract

The utility model discloses an implantable medical equipment and preparation frock belongs to implantable medical device technical field, including casing and inductive coil, the inductive coil is wound in the outside of casing, the inductive coil is wound respectively along the X -axis, Y -axis and Z -axis direction of casing outside casing. The inductive coil is reasonably arranged in the outside of titanium metal casing or other alloy metal casing, can effectively avoid metal shield and eddy current loss, coats the biocompatibility coating outside the inductive coil, guarantees to human body non -toxicity and does not conduct electricity. Through the layout of the inductive coil of X -axis, Y -axis, Z -axis three directions, can further increase the capture efficiency to the external inductive magnetic field, thereby has improved wireless energy transmission efficiency significantly. The utility model also provides a frock for winding the above inductive coil, including upper and lower clamping plate and corresponding profiling position, to ensure that the coil is tightly attached to the casing when winding.

Description

Technical Field

[0001] This utility model relates to the field of implantable medical device technology, and in particular to an implantable medical device and its preparation tooling. Background Technology

[0002] Implantable cardiac monitors (ICMs) are primarily used to monitor a patient's cardiac health and report various cardiac events, such as atrial fibrillation, atrial flutter, and premature ventricular contractions (PVCs). Some ICM models also include heart failure monitoring, respiratory and sleep monitoring, and fall detection functions to achieve comprehensive monitoring of the patient's condition.

[0003] As functionality increases, device power consumption also rises. Current implantable cardiac monitors generally use disposable, non-rechargeable batteries with a lifespan of approximately three years, which is insufficient to meet higher energy demands. For example, during heart failure monitoring, it is necessary to apply a transthoracic impedance drive signal to the patient and monitor the impedance, which significantly increases the device's power consumption.

[0004] In larger implantable medical devices (such as pacemakers, brain stimulators, sacral nerve stimulators, etc.), the induction coil is usually placed inside the head made of epoxy resin. Since the head itself is non-conductive, it does not shield the charging signal. The induction coil can wirelessly charge the battery by connecting to the rectifier and filter circuit inside the titanium shell.

[0005] However, implantable cardiac monitors (ICMs) are small in size, and their headers are correspondingly smaller. Placing the induction coil within a small header makes it difficult to obtain a sufficiently large coil area to ensure effective sensing capability; placing the coil inside a titanium casing would be significantly affected by the metal shielding effect. Simultaneously, titanium casings are prone to eddy current losses, further reducing charging efficiency. Although there have been attempts to use polymer materials as device shells for wireless charging, their airtightness and impermeability are still inferior to titanium shells. Due to its comprehensive advantages in biocompatibility, sealing, and mechanical strength, titanium remains the ideal shell material. Utility Model Content

[0006] This invention aims to solve the problem of achieving high-efficiency inductive charging while continuing to use a titanium shell, and provides an implantable medical device and its preparation tooling.

[0007] To achieve the above objectives, the technical solution of this utility model is as follows:

[0008] First, this utility model provides an implantable medical device, including a housing and an induction coil. The induction coil is wound around the outside of the housing and connected to the electrical circuit inside the housing, which can effectively avoid metal shielding and eddy current loss, thereby improving charging efficiency.

[0009] In one embodiment, the induction coil is wound around the outside of the housing along the X-axis direction.

[0010] In one embodiment, the induction coil is wound around the outside of the housing along the Y-axis and Z-axis directions. The induction coil in this direction can be coupled with external magnetic field components perpendicular to the Y-axis and Z-axis, thereby generating an induced current and improving the receiving efficiency.

[0011] In one embodiment, the outer layer of the induction coil is coated with a biocompatible coating to ensure that it is non-toxic to the human body and non-conductive, and to meet the biocompatibility requirements for implantation.

[0012] In one embodiment, the device further includes a battery and a head, which are respectively mounted at both ends of the housing, and the induction coil is wound around the outside of the battery and the housing.

[0013] In one embodiment, a feedthrough is provided inside the head, one end of which is connected to an electrical circuit inside the housing, and the other end is connected to a terminal of the induction coil, thereby transmitting the electrical energy or signal sensed by the induction coil to the electronic circuit inside the housing.

[0014] In one embodiment, a fixed anchor is installed between the housing and the head, and the feed passage passes through the fixed anchor.

[0015] In one embodiment, electrodes and an antenna are also provided inside the head.

[0016] Secondly, this utility model also provides a preparation tool for preparing any of the above-mentioned implantable medical devices, including an upper clamp and a lower clamp, wherein a first contouring position is provided on the upper clamp and the lower clamp respectively, and the shape of the first contouring position matches the upper end face and the lower end face of the implantable medical device.

[0017] In one embodiment, the device further includes a head splint and a tail splint. The tail splint has a second contouring position that matches the shape of the tail of the implantable medical device. The head splint has a third contouring position that matches the shape of the head of the implantable medical device.

[0018] The preparation tooling ensures that the coils are arranged tightly and orderly and fit against the surface of the housing during the winding process of the implantable medical device.

[0019] Beneficial effects: This invention rationally arranges the induction coils on the outside of a titanium metal shell or other alloy metal shell, and connects the induction coils to the internal electrical circuit of the shell through a feedthrough. This effectively avoids metal shielding and eddy current losses. A biocompatible coating is applied to the outside of the induction coils to ensure non-toxicity and non-conductivity to the human body, while meeting implantable biocompatibility requirements. The arrangement of induction coils along the X, Y, and Z axes further increases the capture efficiency of external induced magnetic fields, thereby significantly improving wireless power transmission efficiency while maintaining the overall miniaturization of the implantable medical device.

[0020] To make the above-mentioned features and advantages of the utility model more apparent and understandable, specific embodiments are described below, and detailed descriptions are provided in conjunction with the accompanying drawings. Attached Figure Description

[0021] Figure 1 This is a three-dimensional structural diagram of an implantable medical device provided in Embodiment 1 of the present invention.

[0022] Figure 2 An exploded view of an implantable medical device provided in Embodiment 1 of this utility model.

[0023] Figure 3 This is a three-dimensional structural diagram of an implantable medical device provided in Embodiment 2 of the present invention.

[0024] Figure 4 This is a three-dimensional structural diagram of an implantable medical device provided in Embodiment 3 of the present invention.

[0025] Figure 5 This is a diagram showing the usage state of the first fixture assembly in the tooling of this utility model.

[0026] Figure 6 This is a three-dimensional structural diagram of the first clamping component in the tooling of this utility model.

[0027] Figure 7 This is a diagram showing the usage state of the second clamping component in the tooling of this utility model.

[0028] Figure 8 This is a three-dimensional structural diagram of the second clamping component in the tooling of this utility model. Detailed Implementation

[0029] To make the objectives and technical solutions of the present utility model clearer, the technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present utility model. All other embodiments obtained by those skilled in the art based on the described embodiments of the present utility model without creative effort are within the scope of protection of the present utility model.

[0030] like Figure 1 As shown, Embodiment 1 of this utility model provides an implantable medical device 1, including a first induction coil 11, a housing 12, a head 13, and a battery 14. The head 13 and the battery 14 are respectively connected to both ends of the housing 12. The housing 12 is made of titanium alloy or other alloy metal. The head 13 is cast with epoxy resin or similar materials and can be transparent. The battery 14 is connected to the housing 12 by laser welding, thereby achieving an integrated seal with the housing 12. This ensures the airtightness of the internal space of the implantable medical device 1 and improves the overall strength and biocompatibility of the implantable medical device 1. Simultaneously, the battery 14 can also serve as an extension structure of the housing 12, facilitating the internal connections and overall layout of the implantable medical device 1.

[0031] The first induction coil 11 is wound around the outer wall of the housing 12 and the battery 14 along the X-axis, which can effectively avoid metal shielding and eddy current loss. In this embodiment, the exterior of the first induction coil 11 is also coated with a biocompatible coating to ensure that it is non-toxic to the human body and non-conductive, and to meet the biocompatibility requirements for implantation.

[0032] For specific details, please refer to... Figure 2 A fixed anchor 131 is provided between the head 13 and the housing 12. The first induction coil 11 is wrapped around the outer wall of the housing 12, the fixed anchor 131, and the battery 14 to form an approximate "D" shape. A feedthrough 132, an electrocardiogram (ECG) electrode 133, and a communication antenna 134 are disposed inside the head 13. The feedthrough 132 passes through the fixed anchor 131, with one end placed inside the housing 12 and connected to the electronic circuitry within the housing 12, and the other end placed inside the head 13 and connected to the terminal of the first induction coil 11 wound around the outer wall of the fixed anchor 131, thereby transmitting the electrical energy or signal sensed by the first induction coil 11 to the electronic circuitry inside the housing 12. The ECG electrode 133 is used to collect cardiac electrophysiological signals, and the communication antenna 134 enables data communication with external devices.

[0033] In this embodiment, the first induction coil 11 is a single coil, and its terminals are respectively connected to the terminals of the feedthrough 132. Of course, the first induction coil 11 can also be composed of multiple coils connected in parallel to the terminals of the feedthrough 132. The parallel connection of multiple coils can reduce the skin effect inside the first coil 11, thereby reducing resistance and heat generation.

[0034] By winding the first induction coil 11 around the outer wall of the battery 14 and the housing 12, and integrating signal acquisition and data communication functions at the front end through the head 13, the design of this integrated structure not only ensures the original biocompatibility, impermeability and mechanical strength of the housing 12, but also realizes efficient wireless charging through the first induction coil 11 and the feedthrough 132, meeting the needs of high-energy-consumption detection scenarios and long-term implantation.

[0035] like Figure 3 As shown in Embodiment 2 of this utility model, an implantable medical device 2 includes a housing 22, a head 23, and a battery 24, as well as a second induction coil 25 and a third induction coil 26. The head 23 and the battery 24 are respectively connected to the two ends of the housing 22. The second induction coil 25 is wound around the outside of the housing 22 and the battery 24 along the Y-axis. The third induction coil 26 is perpendicular to the second induction coil 25 and is wound around the outer wall of the housing 22 and the battery 24 along the Z-axis. Similarly, the terminals of the second induction coil 25 and the third induction coil 26 are connected to a feedthrough (not shown in the figure) inside the housing 22, through which electrical energy or signals are transmitted to the electronic circuit inside the housing 22. Of course, for ease of understanding, the second induction coil 25 and the third induction coil 26 are shown in the figure. In actual operation, the second induction coil 25 and the third induction coil 26 can be a one-to-one corresponding whole, forming a coil with a "U"-shaped cross-section and looped around the outer wall of the housing 22 and the battery 24. The second induction coil 25 and the third induction coil 26 can couple with external magnetic field components perpendicular to the Y and Z axes, thereby generating an induced current and improving the receiving efficiency. In this embodiment, the outer sides of both the second induction coil 35 and the third induction coil 36 can be coated with a biocompatible coating.

[0036] like Figure 4As shown, Embodiment 3 of this utility model provides an implantable medical device 3. Compared with Embodiment 1, in addition to including a first induction coil 31, a housing 32, a head 33, and a battery 34, it also includes a second induction coil 35 and a third induction coil 36. The head 33 and the battery 34 are respectively connected to the two ends of the housing 32. The first induction coil 31 is wound around the outer wall of the housing 32 and the battery 34 along the X-axis direction. The second induction coil 35 is wound around the outside of the housing 32 and the battery 34 along the Y-axis direction. The third induction coil 36 is perpendicular to the second induction coil 35 and is wound around the outer wall of the housing 32 and the battery 34 along the Z-axis direction. The terminals of the first induction coil 31, the second induction coil 35, and the third induction coil 36 are all connected to the feedthrough inside the housing 32.

[0037] Compared to Embodiment 2, this embodiment adds a first induction coil 31 in the X-axis direction, which is perpendicular to the second induction coil 35 and the third induction coil 36. This allows it to capture electromagnetic field components in different directions, achieving omnidirectional reception of external induction signals and significantly improving the overall induction efficiency.

[0038] Please combine Figures 5 to 8 This utility model also provides a preparation tool for preparing the induction coil of the above-mentioned implantable medical device, including a first clamping assembly 41 and a second clamping assembly 42. Taking the implantable medical device 3 provided in Embodiment 3 of this utility model as an example, the first clamping assembly 41 and the second clamping assembly 42 are respectively used to clamp the upper and lower sides and the left and right sides of the implantable medical device 3, which plays a limiting role on the implantable medical device 3 and facilitates the winding of the first induction coil, the second induction coil and the third induction coil.

[0039] Specifically, such as Figure 5 and Figure 6 As shown, the first clamping assembly 41 includes an upper clamping plate 411 and a lower clamping plate 412. The upper clamping plate 411 and the lower clamping plate 412 are each provided with a first contouring position 413, which is used to limit the upper end face and the lower end face of the implantable medical device 3, respectively, and then to wind the first induction coil 31.

[0040] like Figure 7 and Figure 8As shown, the second clamping assembly 42 includes a head clamp 421 and a tail clamp 422. Similarly, the tail clamp 422 has a second contouring position 423 for limiting the tail of the implantable medical device 3. In addition to having a third contouring position 424, the head clamp 421 also has a first hole 425 and a second hole 426. When limiting the head 33 of the implantable medical device 3, the fixing anchor 331 and feedthrough 332 inside the head 33 are respectively placed in the first hole 425 and the second hole 426, which facilitates the winding of the second induction coil and the third induction coil.

[0041] The cooperation of the first clamping assembly 41 and the second clamping assembly 42 ensures that the coils of the implantable medical device 3 are arranged tightly and orderly during winding, and are in contact with the surfaces of the housing 32 and the battery 34.

[0042] Taking the implantable medical device 3 provided in Embodiment 3 of this utility model as an example, its manufacturing process may include the following steps:

[0043] (1) Shell preparation;

[0044] The housing 32, which contains the internal electronic circuits, is welded and sealed to the battery 34, and the feedthrough 332 is passed through the fixing anchor 331 and welded to the housing 32.

[0045] (2) Pre-connection of coil terminals;

[0046] Connect one terminal of the first induction coil 31, the second induction coil 35 and the third induction coil 36 to one terminal of the feedthrough 332 to ensure that they are electrically connected.

[0047] (3) Coil winding;

[0048] The implantable medical device 3 prepared in step (2) is placed between the upper clamp 411 and the lower clamp 412, and its upper and lower end faces are limited by the first contour position 413. Then, the first induction coil 31 is wound along the X-axis.

[0049] The implantable medical device 3, with the first induction coil 31 wound around it, is then placed between the head clamp 421 and the tail clamp 422, and its tail and head 33 are limited by the second contour position 423 and the third contour position 424. Then, the second induction coil 35 is wound along the Y-axis direction and the third induction coil 36 is wound along the Z-axis direction.

[0050] Of course, the order in which the first induction coil 31 is wound and the second induction coil 35 and the third induction coil 36 are wound can be interchanged without affecting the overall manufacturing process;

[0051] (4) Coil pre-fixation and coating application;

[0052] After the winding is completed, the first induction coil 31, the second induction coil 35 and the third induction coil 36 are initially fixed by applying glue or other curing methods locally. Then, as needed, components such as ECG electrodes and communication antennas are installed and connected. Finally, a biocompatible protective layer is coated or integrally molded on the outer surface of the coil, and the head 33 is formed by casting.

[0053] The above winding process ensures the quality and consistency of the small coil winding, providing a good foundation for subsequent wireless charging and packaging.

[0054] In summary, the implantable medical device provided by this invention rationally arranges the induction coils on the outside of a titanium metal shell or other alloy metal shell. The induction coils are connected to the internal electrical circuitry of the shell via a feedthrough, effectively avoiding metal shielding and eddy current losses. A biocompatible coating is applied to the outside of the induction coils to ensure non-toxicity and non-conductivity to the human body, while meeting implantable-grade biocompatibility requirements. The arrangement of the induction coils along the X, Y, and Z axes further increases the capture efficiency of external induced magnetic fields, thereby significantly improving wireless power transmission efficiency while maintaining the overall miniaturization of the implantable medical device.

[0055] Although the present invention has been disclosed above by way of embodiments, it is not intended to limit the present invention. Anyone skilled in the art can make some modifications and refinements without departing from the spirit and scope of the present invention. Therefore, the scope of protection of the present invention shall be determined by the appended claims.

Claims

1. An implantable medical device, characterized in that, It includes a housing and an induction coil, the induction coil being wound around the outside of the housing and connected to an electrical circuit inside the housing.

2. The implantable medical device according to claim 1, characterized in that, The induction coil is wound around the outside of the housing along the X-axis direction.

3. An implantable medical device according to claim 1 or 2, characterized in that, The induction coil is wound around the outside of the housing along the Y-axis and Z-axis directions.

4. An implantable medical device according to claim 1, characterized in that, The outer layer of the induction coil is coated with a biocompatible coating.

5. An implantable medical device according to claim 1, characterized in that, It also includes a battery and a head, which are respectively mounted at both ends of the housing, and the induction coil is wound around the outside of the battery and the housing.

6. An implantable medical device according to claim 5, characterized in that, A feedthrough is provided inside the head, one end of which is connected to the electrical circuit inside the housing, and the other end is connected to the terminal of the induction coil.

7. An implantable medical device according to claim 6, characterized in that, A fixed anchor is installed between the housing and the head, and the feed passage passes through the fixed anchor.

8. An implantable medical device according to claim 7, characterized in that, The head also contains electrodes and an antenna.

9. A preparation tool, characterized in that, The device for manufacturing the implantable medical device according to any one of claims 1 to 8 includes an upper clamp and a lower clamp, wherein a first conforming position is provided on the upper clamp and the lower clamp, and the shape of the first conforming position matches the upper end face and the lower end face of the implantable medical device.

10. A preparation tooling according to claim 9, characterized in that, It also includes a head splint and a tail splint. The tail splint has a second contouring position that matches the shape of the tail of the implantable medical device. The head splint has a third contouring position that matches the shape of the head of the implantable medical device.

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