阅读说明：本技术 具有两个头部的植入式神经刺激装置 (Implantable neurostimulation device with two heads ) 是由 彼得·斯科特·瓦尔莱克·辛格 约翰·路易斯·帕克 于 2019-06-26 设计创作，主要内容包括：一种植入式神经刺激装置(101),其具有包含刺激电子器件(105)和电池(107)的主体(103)。装置(101)具有分别耦合到主体(103)的第一头部(109)和第二头部(117)。在一些示例中,第一头部(109)包含充电线圈(111)和用于刺激引线(115)的连接器(113),并且第二头部(117)包含通信天线(119)。还公开了一种制造植入式神经刺激装置的方法。(An implantable nerve stimulation device (101) has a body (103) containing stimulation electronics (105) and a battery (107). The device (101) has a first head (109) and a second head (117) coupled to the body (103), respectively. In some examples, the first head (109) contains a charging coil (111) and a connector (113) for a stimulation lead (115), and the second head (117) contains a communication antenna (119). A method of manufacturing an implantable neurostimulation device is also disclosed.)

1. An implantable neural stimulation device, comprising:

a body comprising stimulation electronics and a battery for providing stimulation energy;

a first head coupled to the body of the device and containing a charging coil for charging the battery and a connector for connecting a stimulation lead to the stimulation electronics to deliver the stimulation energy from the battery under control of the stimulation electronics; and

a second head coupled to the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device.

2. The device of claim 1, wherein the body comprises a tube having an open end, and the first and second heads are attached to the body to close the respective open ends.

3. The apparatus of claim 1 or 2, further comprising:

a first set of electronics leads for providing a link between the stimulation electronics and the first head, and a second set of electronics leads for providing a link between the stimulation electronics and the second head.

4. The apparatus of claim 3, wherein the second set of electronics leads is located between the stimulation electronics and communication electronics.

5. The apparatus of claim 3 or 4, wherein at least one of the first set of electronics leads and/or the second set of electronics leads is a flexible lead, and the flexible lead is configured to fold as the first head and the second head, respectively, move closer to the body.

6. The apparatus of claim 5, wherein the first set of electronic device leads and/or the second set of electronic device leads are configured to fold into an S-shape.

7. The apparatus of claims 3-6, wherein at least one of the first and/or second sets of electronics leads is a rigid lead.

8. The apparatus of claims 3-7, wherein the links associated with the first and/or second sets of electronic leads further comprise one or more electrical connectors.

9. The apparatus of any of claims 3-8, wherein the first and/or second sets of electronics leads are coupled to the first and second headers, respectively, via first and/or second feedthroughs associated with the first and second headers, respectively, with the communications electronics located therebetween.

10. The device of any one of the preceding claims, wherein the first head and the second head are located at opposite sides of the body.

11. The device of any one of claims 4 to 10, wherein the communication electronics are located proximal to the second head.

12. The apparatus of any preceding claim, wherein the communications antenna is a radio frequency communications antenna.

13. The apparatus of any preceding claim, wherein the communications antenna is a two turn antenna.

14. A method of manufacturing an implantable neurostimulation device, the device comprising a body containing stimulation electronics, the body comprising a tube having an open end, the device further comprising a first head and a second head, the first head comprising a first cap and the second head comprising a second cap, the method comprising:

coupling a first set of electronics leads to provide a link between the stimulation electronics and the first head;

coupling a second set of electronics leads to provide a link between the stimulation electronics and the second head;

wherein the second set of electronics leads is located between the stimulation electronics and communication electronics;

wherein at least the second set of electronics leads are flexible leads and are configured to fold as the first and second heads move closer to the body, respectively; and

coupling the first and second heads to the body to close the respective open ends by:

moving the first and second heads toward the body such that the first and second caps close the respective open ends; and

forming a seal between the first cap, the second cap, and the respective end.

15. The method of claim 14, wherein the communication electronics are located proximal to the second head.

16. An implantable neural stimulation device, comprising:

a body, comprising:

stimulation electronics;

communication electronics in communication with the stimulation electronics;

one or more support elements; and

a battery that provides stimulation energy;

a first head coupled to the body of the device and including a charging coil to charge the battery; and

at least one connector connecting a stimulation lead to the stimulation electronics to deliver the stimulation energy from the battery under control of the stimulation electronics;

a second head coupled to the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device;

a second set of electronics leads providing a link between the communications electronics and the communications antenna in the second head;

wherein the one or more support elements are configured to isolate the second set of electronic device leads from a surface of the body.

17. The apparatus of claim 16, wherein the one or more support elements are configured to guide the second set of electronic device leads to fold in a consistent specified configuration when the second head is coupled to the body.

18. The device of claim 14 or 15, wherein the at least one connector is provided at the first head and/or the second head.

19. The apparatus of any of claims 16 to 18, further comprising:

a first set of electronics leads providing a link between the stimulation electronics and the first head.

20. An implantable neural stimulation device, comprising:

a body comprising stimulation electronics and a battery for providing stimulation energy;

a first head coupled to the body of the device and including a charging coil to charge the battery;

a second head coupled to the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device.

21. The apparatus of claim 20, wherein the body further comprises:

a printed circuit board;

a temperature sensor connected to the printed circuit board; and

a rectifier connected to the printed circuit board.

22. An implantable neural stimulation device, comprising:

a body comprising stimulation electronics and a battery for providing stimulation energy, wherein the body comprises a first portion and a second portion;

a first head coupled to the first portion of the body and including a charging coil to charge the battery;

a second head coupled to the first portion of the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device; and

a connector connecting a stimulation lead to the stimulation electronics to deliver stimulation energy from the battery under control of the stimulation electronics.

23. The apparatus of claim 22, wherein the first portion of the body and the second portion of the body are welded together to form the body.

24. A method of manufacturing an implantable neurostimulation device, the device comprising a body having at least a first portion and a second portion to contain stimulation electronics and a battery, a first head containing a charging coil, a second head containing a communication antenna, and at least one connector in the first head and/or second head that connects a stimulation lead to stimulation electronics to deliver stimulation energy from the battery under control of the stimulation electronics, the method comprising:

forming a first portion having at least one lid, wherein the lid has a feedthrough to couple with components of respective first and second headers;

coupling the feedthrough with at least the stimulation electronics and the battery;

attaching the first portion of the body to the second portion of the body to seal the stimulation electronics and the battery inside the body; and

coupling respective first and second headers to the body, wherein components of the headers communicate with components in the body via the feedthroughs.

25. The method of claim 26, wherein attaching the first portion of the body and the second portion of the body comprises welding the first portion of the body to the second portion of the body.

26. The method of claim 24 or 25, further comprising:

-positioning a clamp at or relative to the first portion to guide one or more flexible leads;

-guiding one or more flexible leads between the feedthrough and at least the stimulation electronics and battery, wherein the one or more flexible leads are guided by the clip to fold in a consistent specified configuration; and

wherein, prior to the step of attaching the first portion of the body to the second portion of the body, the method further comprises:

-removing the clamp from the first part.

27. The device of any one of claims 1 to 13, 16 to 23, wherein the stimulation electronics are disposed at a printed circuit board contained in the body, wherein the printed circuit board has at least one notch for at least one set of electronics leads linking the printed circuit board to the first or second head to fold in the notch.

28. The device of any one of claims 1-13, 16-23, and 27, wherein the second head portion contains another charging coil to charge the battery.

29. A method of manufacturing an implantable neurostimulation device, the device comprising a body containing stimulation electronics, the body comprising a tube having an open end, the device further comprising a first head and a second head, the first head comprising a first cap and the second head comprising a second cap, the method comprising:

coupling a first set of electronics leads to form a link between the stimulation electronics and a feedthrough at the first lid;

coupling a second set of electronics leads to form a link between the stimulation electronics and a feedthrough at the second lid, wherein the second set of electronics leads are flexible leads;

preforming the second set of electronic device leads with one or more mandrels to provide a preformed second set of electronic device leads having one or more curves, wherein the preformed second set of electronic device leads are configured to fold in a consistent specified configuration; and

coupling the first and second heads to the body to close the respective open ends by:

moving the first and second heads toward the body such that the first and second covers close the respective open ends and fold the pre-formed second set of electronic device leads in a consistent and specified configuration; and

a seal is formed between the first cap, second cap and the respective end.

30. The method of claim 29, wherein the one or more mandrels comprise at least two mandrels, wherein the at least two mandrels pre-form at least a portion of the second set of electronic device leads into an S-shape.

Technical Field

The present disclosure relates to an implantable neurostimulation device. In some examples, the device may be used to treat a medical condition.

Background

In recent decades, medical devices having one or more active implantable components have provided a wide range of therapeutic benefits to patients. Implantable neurostimulation devices are examples of such medical devices, and may be used to generate and deliver electrical pulses to tissue to treat various medical conditions and diseases. Implantable neurostimulation devices may be used in spinal cord stimulation systems. Implantable neurostimulation devices may also be used for deep brain stimulation, sacral neurostimulators, cochlear implants, or pacemakers.

The stimulation system typically includes an implantable neurostimulation device, which typically includes a housing or body that encloses electronics/circuitry for generating the electrical pulses. The implantable neurostimulation device may be placed under the skin by a medical professional. The stimulation leads are used to conduct electrical pulses from the implantable neurostimulation device to a specific site to target the desired tissue. Electrodes on the ends of the stimulation leads are typically used to deliver electrical pulses to the desired tissue.

The implantable neurostimulation device also includes a head attached to the housing or body. The header may be used to receive the stimulation lead and provide a point of communication or connection, such as connecting the electronics lead to the electronics/circuitry of the device.

Traditionally, prior art implantable neurostimulation devices include a head. In this way, the components of the charging coil, connector and communication antenna are included in a single header. Since they are all in one header, this means that there is a limit to the size of various components (such as the charging coil) therein.

Throughout this specification the word "comprise", or variations such as "comprises" or "comprising", will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps.

Any discussion of documents, acts, materials, devices, articles or the like which has been included in the present specification is not to be taken as an admission that any or all of these matters form part of the prior art base or were common general knowledge in the field relevant to the present disclosure as it existed before the priority date of each claim of this application.

SUMMARY

An implantable neural stimulation device, comprising: a body comprising stimulation electronics and a battery for providing stimulation energy; a first head coupled to the body of the device and containing a charging coil for charging the battery, and a connector for connecting the stimulation lead to stimulation electronics to deliver stimulation energy from the battery under control of the stimulation electronics; a second head coupled to the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device.

The body may comprise a tube having an open end, and the first and second heads may be attached to the body to close the respective open ends. In some examples, this creates a hermetic container for the stimulation electronics and battery.

The apparatus may include a first set of electronics leads to provide a link between the stimulation electronics and the first head.

The device may also include a second set of electronics leads to provide a link between the stimulation electronics and the second head. In some examples, the second set of electronics leads is located between the stimulation electronics and the communication electronics.

The first set of electronics leads and/or the second set of electronics leads may be flexible leads. The flexible leads may be a flexible flat cable and/or a flexible printed circuit. The first set of electronics leads and/or the second set of electronics leads may be configured to fold (collapse) as the first head and the second head, respectively, move closer to the body.

The first set of electronic device leads and the second set of electronic device leads may be configured to fold into an S-shape or a Z-shape.

In some examples, at least one of the first set of electronics leads and/or the second set of electronics leads is a rigid lead.

In other examples, the links associated with the first set of electronic device leads and/or the second set of electronic device leads further include one or more electrical connectors.

The first and second sets of electronics leads may be coupled to the first and second headers via first and second feedthroughs (feedthroughs) respectively associated with the first and second headers, respectively, with the communications electronics located between the second set of electronics leads and the second feedthroughs.

The first and second heads may be located at opposite sides of the body.

The communication electronics may be located proximal to the second head.

The communications antenna may be a radio frequency communications antenna. The communication antenna may be a two turn antenna.

A method of manufacturing an implantable neurostimulation device, the device comprising a body containing stimulation electronics, the body comprising a tube having an open end, the device further comprising a first head and a second head, the first head comprising a first cap and the second head comprising a second cap, the method comprising: coupling a first set of electronics leads to provide a link between stimulation electronics and the first head; coupling a second set of electronics leads to provide a link between stimulation electronics and a second head; wherein the second set of electronics leads is located between the stimulation electronics and the communications electronics; wherein at least the second set of electronics leads are flexible leads and are configured to fold as the first and second heads respectively move closer to the body; and coupling the first and second heads to the body to close the respective open ends by: moving the first and second heads toward the body such that the first and second caps close the respective open ends; and forming a seal between the first cap, the second cap, and the closed respective ends.

In the method, the communication electronics may be located proximal to the second head.

An implantable neural stimulation device, comprising: a body, the body comprising: stimulation electronics; communication electronics in communication with the stimulation electronics; one or more support elements; and a battery to provide stimulation energy; a first head coupled to a body of the device and including a charging coil to charge a battery; and at least one connector to connect the stimulation lead to stimulation electronics to deliver stimulation energy from the battery under control of the stimulation electronics; a second head coupled to the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device; a second set of electronics leads to provide a link between the communications electronics and the communications antenna in the second head; wherein the one or more support elements are configured to isolate the second set of electronic device leads from the surface of the body.

The one or more support elements may be configured to guide the second set of electronic device leads to fold in a consistent, specified configuration when the second head is coupled to the body.

At least one connector may be provided at the first head. At least one connector may be provided at the second header.

The apparatus may also include a first set of electronics leads to provide a link between the stimulation electronics and the first head.

An implantable neural stimulation device, comprising: a body comprising stimulation electronics and a battery for providing stimulation energy; a first head coupled to a body of the device and including a charging coil to charge a battery; a second head coupled to the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device.

The body may further include a printed circuit board; a temperature sensor connected to the printed circuit board; and a rectifier connected to the printed circuit board.

An implantable neural stimulation device, comprising: a body containing stimulation electronics and a battery for providing stimulation energy, wherein the body comprises a first portion and a second portion; a first head coupled to a first portion of the body and including a charging coil to charge the battery; a second head coupled to the first portion of the body and including a communication antenna to provide communication between the stimulation electronics and an external communication device; and a connector to connect the stimulation lead to stimulation electronics to deliver stimulation energy from the battery under control of the stimulation electronics.

In some examples of the apparatus, the stimulation electronics are disposed at a printed circuit board contained in the body, wherein the printed circuit board has at least one notch for at least one set of electronics leads linking the printed circuit board to the first head or the second head to fold in the notch.

In some examples of the apparatus, the second head includes another charging coil to charge the battery.

The first portion of the body and the second portion of the body may be welded together to form the body.

A method of manufacturing an implantable neurostimulation device, the device comprising: a body having at least a first portion and a second portion to contain stimulation electronics and a battery; a first head containing a charging coil; a second header containing a communication antenna; and at least one connector in the first head and/or the second head to connect the stimulation lead to stimulation electronics to deliver stimulation energy from the battery under control of the stimulation electronics. The method comprises the following steps: forming a first portion having at least one lid, wherein the lid has a feedthrough to couple with components of respective first and second headers; coupling a feedthrough with at least stimulation electronics and a battery; attaching a first portion of the body to a second portion of the body to seal the stimulation electronics and the battery inside the body; and coupling the respective first and second headers to the body, wherein components of the headers communicate with components in the body via the feedthroughs.

In the method, coupling the first portion of the body and the second portion of the body to close the respective open surfaces may include welding the first portion of the body and the second portion of the body.

In some examples, the method further comprises: positioning a clamp (jig) at or relative to the first portion to guide one or more flexible leads; and directing one or more flexible leads between the feedthrough and at least the stimulation electronics and the battery, wherein the one or more flexible leads are directed by the clip to fold in a consistent specified configuration. The method further comprises removing the clip from the first part prior to the step of attaching the first part of the body to the second part of the body.

A method of manufacturing an implantable neurostimulation device, the device comprising a body containing stimulation electronics, the body comprising a tube having an open end, the device further comprising a first head and a second head, the first head comprising a first cap and the second head comprising a second cap, the method comprising: coupling a first set of electronics leads to form a link between stimulation electronics and the feedthrough at the first lid; coupling a second set of electronics leads to form a link between the stimulation electronics and the feedthrough at the second lid, wherein the second set of electronics leads are flexible leads; preforming the second set of electronic device leads with one or more mandrels to provide a preformed second set of electronic device leads having one or more curves, wherein the preformed second set of electronic device leads are configured to fold in a consistent specified configuration; and coupling the first and second heads to the body to close the respective open ends by: moving the first and second heads toward the body such that the first and second covers close the respective open ends and folding the pre-formed second set of electronic device leads in a consistent and specified configuration; and forming a seal between the first cap, the second cap, and the respective ends.

In some examples, the one or more mandrels include at least two mandrels, wherein the at least two mandrels pre-form at least a portion of the second set of electronic device leads into an S-shape.

Brief Description of Drawings

Fig. 1 illustrates an implantable neurostimulation device;

fig. 2 illustrates a body of an implantable neurostimulation device;

FIG. 3 shows an example of a second header;

fig. 4 illustrates a method of manufacturing an implantable neurostimulation device;

5(a) to 5(b) show examples of configurations of a first set of electronic device leads and a second set of electronic device leads;

fig. 6 illustrates another example of a body of an implantable neurostimulation device having a support element for an electronics lead;

fig. 7 illustrates another example of an implantable neural stimulation device having a connector at a second head;

fig. 8 shows another example of an implantable neurostimulation device with connectors at both heads;

fig. 9 shows another example of a body for an implantable neurostimulation device;

fig. 10 illustrates another method of manufacturing an implantable neurostimulation device;

FIG. 11 is a schematic illustration of a body having a coupler (coupling) with rigid feedthrough pins coupled to a PCB of stimulation electronics;

fig. 12 is a schematic example of a body with a coupler with a flexible link to connect the feedthrough pins to the PCB of the stimulation electronics;

fig. 13 is a schematic illustration of a body having a coupler with electrical connectors to connect feedthrough pins to a PCB of stimulation electronics;

fig. 14 shows a schematic diagram of internal components of another example of an implantable neurostimulation device;

fig. 15(a) -15 (d) illustrate a sequence of aligning an electronics lead using a clamp during assembly of an implantable neural stimulation device;

16(a) -16 (d) illustrate a sequence of pre-forming an electronic device lead with a mandrel to provide a consistent fold of the electronic device lead;

FIG. 17 is a schematic top view of another example having a support structure for supporting a PCB and support elements for guiding leads of an electronic device;

FIG. 18 is another view of the support structure and PCB of FIG. 17 with the electronic device leads prior to assembly; and

fig. 19 is another view of the support structure and PCB of fig. 17 with the electronic device leads assembled and guided by the support elements.

Description of the embodiments

SUMMARY

Fig. 1 shows an example of an implantable neurostimulation device 101. The device may be used in a spinal cord stimulation system. The device 101 comprises a body 103 containing stimulation electronics 105 and a battery 107 for providing stimulation energy. In some examples, the stimulation electronics may be mounted on a printed circuit board.

Device 101 also includes a first head 109 coupled to body 103 of device 101 and containing a charging coil 111 to charge battery 107. First head 109 also includes a connector 113 to connect stimulation lead 115 to stimulation electronics 105 to deliver stimulation energy from battery 107 under the control of stimulation electronics 105. Stimulation lead 115 may deliver stimulation energy to a specific site to target desired tissue.

The device 101 also includes a second head 117 coupled to the body 103 and containing a communication antenna 119 to provide communication between the stimulation electronics 105 and an external communication device 121. In some examples, the communication antenna 119 is a Radio Frequency (RF) coil. The external communication device 121 may be associated with a medical professional.

Details of exemplary implantable neurostimulation device 101 will now be described in detail.

Body 103 including stimulation electronics 105 and battery 107

As described above, implantable neurostimulation device 101 includes a body 103 that includes stimulation electronics 105. One example of a body 103 is shown in fig. 2. In this example, the body 103 comprises a tube 201 having open ends 203, 205. First head 109 and second head 117 may be coupled to close respective open ends 203, 205.

The tube 201 may be constructed of titanium. In another example, the tube may be constructed of a biocompatible ceramic. It should be understood that other biocompatible materials may be used, including bio-grade (biograde) stainless steel, bio-grade glass, silicon, alumina, zirconia, quartz, or metal alloys.

A first set of electronics leads 123 provides a link between stimulation electronics 105 and first header 109. The second set of electronics leads 125 provide a link between the stimulation electronics 105 and the second head 117. The body 103 and the open ends 203, 205 are configured to allow the first set of electronics leads 123 and the second set of electronics leads 125 to pass through the respective open ends 203, 205 during assembly.

The stimulation electronics 105 may include a microcontroller (uC) to: managing communication with the programming system and the patient remote, managing charging of the rechargeable battery, and other such housekeeping functions. The stimulation electronics 105 may also include a second microcontroller to manage patient therapy that controls an Analog Only Chip (AOC) to provide a current source and an evoked response amplifier. The stimulation electronics 105 may also include support components such as resistors, capacitors, power supplies, and the like. The first microcontroller, the second microcontroller, and the AOC may be packaged in a ball grid array (BGA package) to mount the components of the stimulation electronics 105 onto the printed circuit board 151. It is desirable to reduce the size of the stimulation electronics so that the size of the implantable pulse generator is minimized.

In some examples, the stimulation electronics 105 may communicate with communication electronics 153 (such as a radio communication module). In some examples, this may include a radio chip, such as a Radio Frequency (RF) chip. The communication electronics 153 may be connected to a printed circuit board 153 associated with the stimulation electronics 105. In this manner, the second set of electronics leads 125 transmit analog communication signals to the communication antenna 119. In other examples, the second set of electronics leads 125 may transmit digital communication signals.

In some examples, the body 103 may include support elements 155, 157 as shown in fig. 6. The support elements 155, 157 may be configured to isolate the second set of electronic device leads 125 from the surface of the body 103. For example, the support elements 155, 157 may isolate the second set of electronics leads 125 from an inner surface of the body 103 (such as an inner wall of the tube 201). In another example, the support element may isolate the second set of electronics leads 125 from the second lid 209. As shown in fig. 6, support elements 155, 157 prevent second set of electronics leads 125 from contacting lid 209, and second set of electronics leads 125 may contact second header 117 via second feedthrough 131. The support element also functions to ensure that the second set of electronic device leads are folded (or otherwise folded) in a consistent and specified configuration. This may be important for matching the antenna to the analog signal from the communication electronics.

Advantageously, the communication electronics 153 may be connected to a printed circuit board 153 associated with the stimulation electronics 103. This reduces interference between the communication antenna 119 and the communication electronics 153.

A second advantage of having the communication electronics 153 connected to the printed circuit board 153 associated with the stimulation electronics 103 is provided by the ease of signal routing between the two modules. The signals between these are the low speed data signal and the clock signal operating at about 1MHz, as well as the dc power signal. The routing for these signals is conventional, as opposed to RF analog signals.

As mentioned above, the device 101 further comprises a battery 107 to provide stimulation energy. In one example, the battery 107 is a rechargeable battery, such as a lithium ion battery or a lithium ion polymer battery.

Charging coil 111 may be configured to charge battery 107. In this way, there may be an external charger or external charging coil that receives power and generates an electromagnetic field. The electromagnetic field generated by the external charging coil may induce a current within the charging coil 111 to charge the battery 107 and thus provide stimulation energy to the stimulation electronics 105. The battery 107 may be recharged while the device is in use.

In order to provide an optimal energy coupling with an external charger or an external charging coil, the charging coil 111 may be as large as possible. In this way, the charging coil 111 may occupy a large amount of space in the first header 109. An advantage of the present disclosure is that the communication antenna 119 is located separately from the charging coil 111 in the second header 117, as this allows the charging coil 111 to occupy a large amount of space in the first header 109.

In one example, the charging coil 111 can include twisted strands.

The first head 109 and the second head 117 may be located at opposite sides of the body. This has the advantage that interference between the charging coil 111 and the communication antenna 119 can be reduced.

First head 109

As described above, the apparatus 101 further comprises a first head 109 coupled to the body 103. As shown in fig. 1, the first head may have a circular shape.

The first head 109 may include a charging coil 111 to charge the battery 107. The charging coil 111 can have a predetermined configuration including a predetermined number of turns and a diameter. For example, the charging coil 111 may have 150 to 300 turns. In other examples, the charging coil 111 may have 50 to 100 turns. The charging coil 111 may be formed of an electromagnetic wire. In one example, the charging coil 111 may have an area of 386sq mm and have 58 turns, each turn containing two strands of gold-plated copper wire with a wire diameter of 120 um.

First head 109 may also include at least one connector 113 to connect stimulation lead 115 to stimulation electronics 105. Each connector 113 may have at least one associated stimulation lead 115. In one example, the connector 113 is a Bal Seal connector. Stimulation energy from battery 107 may then be delivered via connector 113 and stimulation lead 115. In one example, the stimulation lead 115 may have one or more electrodes for contacting the desired tissue for treatment.

Apparatus 101 may also include a first set of electronics leads 123 to provide a link between stimulation electronics 105 and first head 109. The first set of electronics leads 123 may include a balseal and a charging flex link. In one example, the balseal and charging flex link may be constructed of a flexible PCB material with 26 wires, with 24 wires for providing a 2x 12 channel electrode lead and the remaining two wires for connecting to the charging coil 111.

The first set of electronics leads 123 may be flexible leads. In this manner, the first set of electronics leads 123 are configured to fold as the first header 109 is moved closer to the body 103 of the apparatus 101. The first set of electronics leads 123 may be configured to fold in an S-shape or a Z-shape. In this manner, the first set of electronic device leads 123 may be configured to be folded (concentertina) into a folded configuration. This is shown in fig. 5 (a). Similarly, the first set of electronics leads 123 are configured to stretch when the first head 109 is moved away from the body 103. This is shown in fig. 5 (b).

The first set of electronics leads 123 may be coupled to the first header 109 via a first feedthrough 129 associated with the first header 109. The first set of electronics leads 123 may be coupled to the first header 109 via a plurality of feedthroughs. The first set of electronics leads 123 may also be connected to a first printed circuit board 133 of the device 101. This is shown in fig. 1. The first feedthrough 129 may also be connected to the first printed circuit board 133. In this manner, the first set of electronics leads 123 may be coupled to the apparatus 101 via the first printed circuit board 133 and the at least one first feedthrough 129.

The first head 109 may include a first cap 207. In this manner, as the first head 109 is moved closer to the body 103 of the device 101, the first cover 207 closes and seals the first open end 203.

Second head 117

As described above, the device 101 further includes a second head 117 coupled to the body 103. As shown in fig. 1, the second head 117 may have a circular shape.

The device 101 may also include a second set of electronics leads 125 to provide a link between the stimulation electronics 105 and the second head 117. As shown in fig. 1, the second set of electronics leads 125 may be located between the stimulation electronics 105 and the communication electronics 127 of the body 103.

In one example, the second set of electronics leads 125 includes communicative flexible links. The communication flex link may be constructed of a flexible PCB material with six wires, including power and ground wires (two wires) and a serial data bus (such as IIC) requiring four wires.

As shown in fig. 1, the communication electronics 127 may be located proximal to the second head 117. In this manner, the communications electronics 127 may be connected to the second printed circuit board 135 associated with the second head 117.

In one example, the communication module 127 may include a MICS band radio chip, such as ZL70103, mounted to a printed circuit board associated with the second head 117. The radio chip may replace or be in addition to the communication electronics 153 associated with the printed circuit board 151 of the stimulation electronics 105, as described above. The printed circuit board may house an antenna matching component and a power supply bypass capacitor. This can be placed in this small space, since it has a few parts.

The communications electronics 127 may include electronics suitable for wireless telemetry, such as radio frequency electronics. The communication electronics 127 may include one or more devices, such as a chip or microcontroller, that provide a communication link between the device 101 and the external device 121. The communications electronics 127 may be used by the external device 121 or an external service provider (such as a medical professional) to control various aspects of the device 101. The communications electronics 127 may also be used to receive data from or transmit data to the external device 121 or an external service provider.

Advantageously, the communication electronics 127 are located proximal to the second head 117. In this manner, the communications electronics 127 are at a fixed distance from the communications antenna 119. The close proximity of the communication electronics 127 to the communication antenna 119 has the advantage of reducing signal/line losses and thereby improving communication between the device 101 and the external device 121 or external service provider.

In some variations, the second header 117 may not include the communication electronics 127. In this manner, communication electronics (such as communication electronics 153) associated with the body 103 of the device 101 may provide a communication link between the device 101 and the external device 121. That is, the communication electronics 153 may be used by the external device 121 or an external service provider (e.g., a medical professional) to control various aspects of the device 101. The communications electronics 153 may also be used to receive data from or transmit data to the external device 121 or an external service provider.

In some examples, the interface to the communication electronics 127 may be one or more leads from the second set of electronics leads 125.

The second set of electronics leads 125 may be flexible leads. In this manner, the second set of electronics leads 125 are configured to fold as the second header 117 is moved closer to the body 103 of the device 101. The second set of electronics leads 125 may be configured to fold in an S-shape or a Z-shape. In this manner, the second set of electronics leads 125 may be configured to be folded into a folded configuration. This is shown in fig. 5 (a). Similarly, the second set of electronics leads 125 are configured to extend when the second head 117 is removed from the body 103. This is shown in fig. 5 (b).

The second set of electronics leads 125 may be coupled to the second header 117 via a second feedthrough 131 associated with the second header 117 such that the communications electronics 127 are located between the second set of electronics leads 125 and the second feedthrough 131. The second set of electronics leads 125 may be coupled to the second header 117 via a plurality of feedthroughs.

The second set of electronics leads 125 may be connected to a second printed circuit board 135 of the apparatus 101. This is shown in fig. 1. The second feedthrough 131 may also be connected to a second printed circuit board 135. In this manner, the second set of electronics leads 125 may be coupled to the apparatus 101 via the second printed circuit board 135 and the at least one second feedthrough 131.

The second set of electronics leads 125 may provide a path for serial data and power communications for the device 101.

As indicated above, the second header 117 includes a communication antenna 119. The communication antenna 119 may be a Radio Frequency (RF) communication antenna. Communication antenna 119 may be a two turn antenna. The communication antenna 119 may be a multi-turn antenna. This has the advantage that the height of the second head 117 can be reduced compared to the first head 109.

An example of a second head 117, 301 is shown in figure 3.

The second head 117 may include a second cap 209. In this manner, the second cap 209 closes and seals the second open end 205 as the second head 117 is moved closer to the body 103 of the device 101.

Method 400 of manufacturing an implantable neurostimulation device

A method 400 of manufacturing an implantable neurostimulation device 101 is also provided, the device 101 comprising a body 103 comprising stimulation electronics 105, the body 103 comprising a tube 201 having open ends 203, 205. The device 101 may further comprise a first head 109 and a second head 117, the first head 109 comprising a first cap 207 and the second head 117 comprising a second cap 209.

Method 400 may also include coupling 402 a first set of electronics leads 123 to apparatus 101 to provide a link between stimulation electronics 105 and first head 109. Coupling 402 may include establishing electrical connections between the first set of electronics leads 123 and the stimulation electronics 105.

The method 400 may also include coupling 404 a second set of electronics leads 125 to the device 101 to provide a link between the stimulation electronics 105 and the second header 117. Coupling 404 may include establishing electrical connections between the second set of electronics leads 125 and the stimulation electronics 105. A second set of electronics leads 125 may be located between the stimulation electronics 105 and the communication electronics 127. In this manner, electrical connections may be established between the stimulation electronics 105, the second set of electronics leads 125, and the communication electronics 127. A communication connection (such as radio frequency) may be further established between the second set of electronics leads 125 and the communication electronics 127.

The first and second sets of electronics leads 123, 125 may be flexible leads and may be configured to fold as the first and second heads 109, 117, respectively, move closer to the body 103. Thus, during assembly, the first and/or second electronics leads 123, 125 may be stretched via the open ends 203, 205 to help easily connect the feedthroughs 129, 131 to the respective first and second printed circuit boards 133, 135. When the heads 109, 117 are moved to close the open ends 203, 205, the electronics leads 123, 125 are folded inside the body 103.

The method 400 further includes coupling 406 the first head 109 and the second head 117 to the body 103 to close and seal the respective open ends 203, 205.

Coupling 406 includes moving 408 the first and second heads 109, 117 toward the body 103 such that the first and second caps 207, 209 close the respective open ends 203, 205. The method 400 further includes forming 410 a seal between the first cover 207, the second cover 209, and the closed respective ends 203, 205.

In the method 400 of manufacturing the device 101, the communication electronics 127 may be located proximal to the second head 117. In this manner, the communications electronics 127 may be connected to the second printed circuit board 135.

Variants

As described above, the first connector 129 of the first header 109 may include at least one Bal Seal connector. In some examples, the second head 117 may include a connector 113. In further examples, the second header 117 may include at least one Bal Seal connector.

In another example of implantable neurostimulation device 101, first head 109 can include only charging coil 111. This is shown in fig. 7. In this example, the second head 119 may include at least one connector 113 to connect the stimulation lead 115 to the stimulation electronics 105 to deliver stimulation energy from the battery 107 under the control of the stimulation electronics 105.

An advantage of this example is that the charging coil 111 may have a higher charging efficiency due to lower interference of the metallic elements (such as the connector 113). The first head 109 may also take a circular shape because the shape of the charging coil 111 may be modified with little or no effect on the charging efficiency of the battery 107.

Another advantage is that the number of turns in the charging coil 111 can be increased. This may result in better charge coupling of the battery 107 and thus better provision of stimulation energy to the stimulation electronics 105.

As shown in fig. 8, the first head 109 may include a first printed circuit board 133. The first printed circuit board 133 may be positioned on the first cover 207. In this example, the first printed circuit board 133 may be connected to the temperature sensor 171. Temperature sensor 171 may detect abnormal operation of device 101.

In another example, the first printed circuit board 133 may also be connected to the rectifier 173. The rectifier 173 may include a bridge rectifier to output a DC voltage to the stimulation electronics 105. The advantage of this example is that the rectifier 173 can reduce the operating noise of the device while charging, since high frequency components (above 425kHz) are eliminated at the rectifier.

Another advantage is that the number of strands in the charging coil 111 can be increased. In one example, the number of stranded strands in the charging coil 111 can be increased from two to three or more. In this way, the addition of stranded strands in the charging coil 111 reduces skin effect losses during charging. The added strand strands in the charging coil 111 can also reduce the resistance of the charging coil 111.

Further variants of the device 101

Fig. 9(a) and 9(b) show another example of an implantable neurostimulation device 101. This example apparatus 101 includes a body 900 containing stimulation electronics 105 and a battery 107 for providing stimulation energy. In some examples, the stimulation electronics may be mounted on the printed circuit board 151. The body 103 may also include communication electronics 153. These are shown in dashed lines in fig. 9(a) and 9(b) to indicate that they are behind the cover 902, as discussed below.

As shown in fig. 9, the body 900 of the device 101 includes a first portion 901 and a second portion 903. The first portion 901 and the second portion 903 (and the cover 902) are attached together to form a sealed body 900 to contain stimulation electronics and the battery 107. This may include welding the first portion 901 and the second portion 903 to each other.

The first portion 901 is formed with one or more covers 902. In some examples, the cover 902 may be integrally formed with the first portion 901. In other examples, the cover 902 is initially a separate component that is welded (or otherwise attached) to the first portion 901. The lid 902 has feedthroughs 129 to couple components of the respective first and second headers (not shown in fig. 9, but described in earlier examples above) with components internal to the body 900.

The first head 109 includes a charging coil 111 to charge the battery 107. The second head 117 includes a communication antenna 119 to provide communication between the stimulation electronics 105 and an external communication device 121. In some examples, the second header 117 may also include communication electronics 127.

First head 109 and/or second head 117 also include connectors to connect stimulation lead 115 to stimulation electronics 105 to deliver stimulation energy from battery 108 under the control of stimulation electronics 105. The connectors in the header(s) in turn communicate with components inside the body 900 via the feedthroughs 129.

The first set of electronics leads 123 are coupled to the first header 109 via feedthroughs 129. In this manner, first set of electronics leads 123 provide a link between stimulation electronics 105 and first header 109. The second set of electronics leads 125 are coupled to the second header 117 via feedthroughs 129 (on the opposite side). In this manner, the second set of electronics leads 125 provide a link between the stimulation electronics 105 and the second header 117.

Fig. 10 illustrates a method 1000 of manufacturing an implantable neurostimulation device 101. the device 101 includes a body 900, the body 900 including a first portion 901 and a second portion 903. The device 101 further comprises a first head 109 comprising a charging coil and a second head 117 comprising a communication antenna. At least one connector is provided in the first head and/or the second head to connect the stimulation lead to stimulation electronics to deliver stimulation energy from the battery under control of the stimulation electronics.

The method 1000 includes forming 1002 a first portion 901 having at least one cover 902 (as shown in fig. 9 (a)). This may include welding (or otherwise attaching) the cover 902 to the first portion 901, or alternatively integrally forming the first portion with the cover. The lid has feedthroughs 129 to couple with components of the respective first and second headers.

The method also includes coupling 1004 the feedthrough 129 with at least the stimulation electronics 105 and the battery 107. Coupling 1004 may include establishing an electrical connection between feedthrough 129 and stimulation electronics 105. Examples of coupling will be described in further detail below, and may include variations, combinations, and permutations of rigid feedthroughs, flexible leads/links (cables; and/or an electrical connector.

The method 1000 further includes attaching 1006 the first portion 901 of the body 900 to the second portion 903 of the body 900 to seal the stimulation electronics and battery inside the body 900 (as shown in fig. 9 (b)).

The method 1000 also includes coupling 1010 the first and second headers to the body such that components of the headers communicate with corresponding components in the body via the feedthroughs 129. In some examples, the head is coupled to the cover(s) 902 of the sealing body 900. This may include coupling the head with epoxy or solder to provide a seal between the head and the body 900.

It should be understood that in some alternative examples, the head may be attached to the cover(s) and/or the first portion 901 prior to the step of attaching 1006 the first portion 901 to the second portion 903.

Examples of couplings

Examples of couplings that establish electrical connections between the feedthrough and the stimulation electronics 105 will now be described with reference to fig. 11-13.

Fig. 11 shows a schematic diagram in which the feedthrough pins 131 have rigid extensions 921 to electrically connect with the PCB 151 of the stimulation electronics 105. In some examples, the continuous, rigid, and electrically conductive feedthrough pins 131 are soldered (or otherwise coupled) directly to the PCB 151.

In one example, the assembly initially includes a lid 902 having a rigid feedthrough pin 902 and a rigid extension 921 attached thereto. The cover 902 is then positioned towards the first portion 901, which includes positioning the extension 921 to the PCB 151. The rigid extension 921 is then attached to the PCB 151 (such as with soldering) and the cover 902 is soldered to the first portion 901. This may be done for the cover 902 at either end of the first portion 901. The second portion 903 (shown in phantom) may then be welded to the first portion 901 and the cover 902. Finally, the heads 109, 117 may be formed at the cover 902.

It should be understood that the above steps may vary. For example, the cover 902 may be soldered to the first portion 901 and then the rigid extension 921 attached to the PCB 151. In yet another example, the first portion 901 and the lid 902 are initially devoid of the PCB 151, the feedthrough pins 131, and the extension 921. The first portion 902 and the lid 902 are soldered together and then the PCB 151, the feedthrough pins 902 and the rigid extensions 921 are positioned and fixed in place (prior to mating the second portion 903 with the assembly).

It should be understood that in other embodiments, the feedthrough pin 131 and the rigid extension 921 are initially separate components, and that during assembly, the feedthrough pin 131 and the rigid extension 921 are brazed or otherwise rigidly connected to one another.

Fig. 12 shows a schematic view of another example, wherein the feedthrough pins 131 are coupled to the PCB 151 at least partially via flexible leads 923. In one example, the lid 902 has the feedthrough pins 131 attached, thereby bringing the lid 902 into proximity with the first portion 901. The flexible leads 923 are then soldered (or otherwise attached) to form electrical connections between the PCB 151 and the feedthrough pins 131. The cover 902 is then positioned and welded to the first portion 901. As described in previous examples, other components may be attached, such as the second portion 903 and the heads 109, 117.

In some examples, the lid has an intermediate part 925 between the feedthrough pin 131 and the flexible lead 923. The intermediate part 925 may comprise another printed circuit board having one or more conductive traces 927. The feedthrough pins 131 and the flexible leads 923 may be soldered or otherwise attached to the traces 927 to complete the electrical connection. The intermediate part 925 may be configured to abut the cover 902, which may improve the strength and rigidity of the part. Although not shown in fig. 12 for clarity, it is understood that flexible lead 923 can be configured to fold in one or more of the configurations described in this specification, including the use of support elements, notches, and/or clips (described in further detail below).

Fig. 13 shows a schematic diagram of yet another example, in which some of the feedthrough pins 131 are coupled to the PCB 151 via electrical connectors 929. In some examples, electrical connector 929 is mounted and electrically coupled to PCB 151. The electrical connector 929 is configured to receive the feedthrough pin 131, making a corresponding electrical connection therewith. In some examples, the feedthrough pins 131 are push-fit into sockets (such as sockets) in the electrical connector 929.

In one example, the body 103 is substantially tubular, having an open end that may be closed by respective covers 902a and 902 b. At a first end, the feedthrough 131a is disposed at the lid 131a and is electrically coupled to the PCB 151 via the extension 921 (or alternatively, the flexible lead 923) in a manner similar to the example described in fig. 11 and 12. The first cover 902b is then positioned toward the body 103 such that the connected PCB 151 slides into the body 103. The second cover 902b has a feedthrough 131b and the feedthrough 131b is received by an electrical connector 929 to complete the electrical coupling when the second cover 902b is brought toward the opposite end of the body 103. The covers 902a and 902b may then be attached (such as by welding) to the body 103.

It should be understood that these steps may be reordered. For example, the second cover 902b may be attached to the body 103 before the first cover 902a and the PCB 151 are slid into the body 103. In another example, the first cover 902a may be attached to the body 103 before the second cover 902b is brought towards the body 103.

In further examples, the body 103 in fig. 13 may be configured to have two or more portions (as in the examples of fig. 9(a) and 9 (b)). This may include positioning one or more covers 902a, 902b and PCB 151 before the first and second portions 901, 903 (or other portions) are assembled together.

In some examples, the use of the rigid extension 921 and/or the electrical connector 929 may be advantageous in providing a predictable and/or repeatable electrical path to the communication antenna 119. This may facilitate antenna matching as compared to a flexible lead between the communications electronics 127 and the communications antenna 119. Thus, in some examples, the communication electronics may be located on the PCB 151, whereby an electrical path to the communication antenna 119 is via the rigid extension 921 and/or the electrical connector 929 (and without the flexible leads).

It is to be understood that various combinations and permutations of the above couplings may be used in other variations.

Further variants of devices with recesses in printed circuit boards

Fig. 14 illustrates internal components of yet another example of an implantable neurostimulation device. In this example, the printed circuit board 151 located in the body 103 has a notch 160 to provide space and clearance for the flexible leads 125 to fold upon assembly. In some other examples, the notch 160 also provides space for the support elements 155, 157. Having a notch 160 may maximize space on the PCB for other electronic components.

In some examples, another notch 162 is provided at the head 117 (and/or 109) to provide additional space and clearance for the flexible lead 125. This may be in conjunction with, or in some examples, as an alternative to, the notch 160.

In examples where the recess 160 is primarily at the PCB 151 in the body 103, this may maximize space for other components in the head(s) 109, 117. For example, space in the head for more strands of the charging coil 111 or antenna 119 is maximized.

An example of an assembly device will now be described. The electrical and electronic components of the first header 109 are soldered to the PCB 151 and/or corresponding components of the battery 107. This may be done while the PCB 151 is separated from the body 103. Without a body, it is easier for a person or machine to solder the plurality of flexible leads. The body 103 (such as a metal sleeve) may then be slid over the PCB 151 and towards the first head 109. The body 103 may then be sealed relative to the first head 109, such as by welding or epoxy. Next, the flexible leads 125 are then soldered to link the PCB 151 with components in the second header 117, such as the antenna 119 or communications electronics. The flexible leads 125 may be provided with some extra length to allow room for human or machine soldering (as the body 103 will reduce the ease of access to the solder of the PCB/second header). The second head 117 is then brought toward the body 103 in a controlled manner to allow the flexible leads 125 to fold/fold in a consistent manner (e.g., tuck the leads). This is aided by a notch 160, which notch 160 provides space for the flexible lead 125 to fold/fold. The second head 117 may then be sealed with respect to the body 103 by soldering or epoxy.

It should be understood that in some examples, the first head 109 may be sealed relative to the body 103 at a later stage (such as while the second head 117 is sealed).

In another variation, another charging coil is located in the second header 117.

Further variants of the method of manufacturing a stimulation device using a clamp

Fig. 15(a) to 15(d) show a sequence of manufacturing the implantable neural stimulation device 101. In this example, the body of device 101 includes at least a first portion 901 and a second portion 903 (not shown in fig. 15, but shown in fig. 9 (b)). The method includes forming a first portion 901 having one or more lids 902, wherein the lids 902 have feedthroughs 129, 131.

In fig. 15(a), the right-hand feedthrough 131 is connected to a flexible lead 931, whereby the flexible lead 931 will in turn be connected to the stimulation electronics 105/PCB 151 (and/or battery). In one particular example, the flexible leads 931 connect to communications electronics on the PCB 151 (or other components mounted to the body).

In fig. 15(b), a jig 933 is located at the first portion 901 to guide the flexible leads 931. In some examples, this includes placing the clamp 933 adjacent to at least a portion of the first portion 901. In other examples, this may include placing a clamp 933 relative to first portion 901 via the intermediate portion. For example, the PCB 151 may be mounted to the first part 901, and then, the clamp 933 is placed to abut the PCB 151.

In fig. 15(c), the flexible leads 931 are guided to the stimulation electronics 105/PCB 151 (and/or battery) with a clamp 933 such that the flexible leads 931 fold in a consistent and specified configuration. The flexible lead 931 is then connected to the stimulation electronics/PCB/battery by soldering or other attachment system. This consistent and prescribed configuration may ensure that flexible leads 931 do not fold in another configuration that may inadvertently bend and cause flexible leads 931 to weaken. This may provide predictable electromagnetic properties for the antenna in case of using the flexible lead 931 for a communication antenna.

In fig. 15(d), the jig 933 is removed from the first part 901. The figure also shows flexible leads 931, which hold the specified configuration caused by the clamp 933. Subsequently, the second portion 903 of the body may be attached to the first portion to seal the stimulation electronics and battery inside the body (using techniques as described in the previous examples).

In the above example, the left hand side feedthrough 129 is linked to the stimulation electronics 105/PCB 151 via a rigid extension 921. It should be understood that in other examples, combinations and variations with other coupling techniques may be used, including using clamp 931 to guide a flexible wire to two covers.

Additional variations of preforming leads for electronic devices

Fig. 16(a) to 16(d) show a sequence of preforming a set of electronic device leads 955 with mandrels 951, 953. By manipulating the set of electronic device leads 955 to a set of pre-formed electronic device leads 965, this can assist in folding the electronic device leads 965 in a consistent, specified, and predictable configuration. This may be important for electronics leads where shape and configuration may affect performance, such as those associated with antennas.

The method may be applied to one or more of the neural stimulation devices described herein, including examples in which the body of the device comprises a tube. For the sake of brevity, we show only the relevant aspects of this variation in fig. 16, and for the avoidance of doubt, other features described herein may be used with this variation.

Fig. 16(a) shows a PCB 151 that may support stimulation electronics, the PCB 151 being coupled to the feedthrough 131 (and/or the second PCB 135 associated with the head) via a set of electronics leads 955. In this example, the electronic device leads are flexible leads so that they can be bent (at least to a threshold) without breaking.

Referring to fig. 16(b), a mandrel 951, such as a cylinder, is provided and the set of electronic device leads 955 is wound around at least a portion of the mandrel 955 to form a first curve on the electronic device leads 955.

In fig. 16(c), an additional mandrel 951 is provided to pre-form the second curve, resulting in a set of pre-formed electronic device leads 965 having an S-shape. It should be understood that other shapes besides S-shaped may be used depending on the desired design shape. For example, "W-shaped" or "U-shaped" may be used.

In fig. 16(d), the mandrels 951, 953 are extracted. In some examples, the electronic device leads 965 can be formed against the mandrels 951, 953 beyond a yield point (yield point) such that the electronic device leads 965 plastically deform and retain (or substantially retain) a shape, such as an S-shape. In other examples, the electronic device leads 965 are elastically deformed after pre-forming, and require additional elements to support and maintain the pre-formed shape.

After the set of pre-formed electronic device leads 965 are created, the other components of the device can be assembled. In particular, the lid with the feed-through 131/second PCB 135 is moved towards the tube. As the cover moves closer to the end of the tube, the set of preformed electronic device leads are folded in a consistent and prescribed configuration, which is determined by the shape of the preform. The cap may then be sealed against the end of the tube.

It is to be understood that different variations and combinations may be used. For example, the first header and cap may have a first set of rigid electronics leads that are rigidly soldered to the PCB 151 (depicted in fig. 15(a) as rigid extensions 921). The PCB 151 is then inserted through the tube with the cap of the first head closing one end of the tube. A second set of flexible electronic leads 955 is then connected between the PCB 151 and the second header feedthrough 131. The mandrel is then positioned and the second set of electronics leads 955 are pre-formed into the desired shape. The mandrel is then withdrawn and the cap of the second head is moved towards the remaining open end of the tube. During this movement, the preformed second set of electronic device leads 965 are folded inside the tube in a consistent and prescribed manner. Finally, the cap of the second head is sealed to the tube.

In yet another example, the first set of electronic device leads and the second set of electronic device leads are each pre-formed from a mandrel.

In some examples, the mandrel is substantially cylindrical in shape. The mandrel may comprise a roller. In other examples, the mandrel may be frustoconical. In further examples, the mandrel may be a prism, such as a rectangular prism, a pentagonal prism, a hexagonal prism, a heptagonal prism, or the like.

Variants with support structures to support the PCB

Fig. 17-19 illustrate another example 971 having a support structure 973 to support the PCB 151 inside the body 103. In one example, the support structure 973 comprises a molded structure that receives the PCB 151, which in turn is closely received in the body 103 (not shown in fig. 17-19, but shown in previous embodiments). This may reduce the likelihood of damage to the PCB due to movement and vibration relative to the body 103 when assembled. In some examples, the support structure 973 provides thermal and/or electrical insulation between the PCB 151 and the body 103. The support structure 973 is made of a polymer. The support structure 973 may be assembled with the PCB 151, after which the support structure 973 and the PCB 151 may be slid into the body 103.

The support structure 973 also includes one or more support members 977, 979 to guide corresponding (flexible) electronic device leads 975. Referring to fig. 18, the first support member 977 is formed by a recess in a peripheral wall surrounding the PCB 151. In this example, the second support element 979 comprises a protrusion in the form of a cylindrical finger.

An electronics lead 975 in the form of a flexible lead 975 is electrically connected to the feedthrough 131. In some examples, this may be through an intermediate second printed circuit board 135 associated with the cover of the head.

The assembly of the electronics leads 975 to the PCB 151 is shown in fig. 19, where the electronics leads 975 are guided in an S-shape by the support members 977, 979. This allows the electronic device leads 975 to fold/fold in a consistent manner. This facilitates assembly of the device, which may include fitting opposing caps (of respective heads) together in the tube 103 as described above.

It should be understood that in some examples, only one support element is used, while in other examples, three or more support elements are used. Further, it should be understood that the support element may be configured to facilitate folding of the electronic device leads 975 in other desired shapes that are consistent and predictable.

In still further examples, one or more support elements are configured to bend, pivot, move, and/or otherwise displace in a specified manner. For example, a support element 979 in the form of a protrusion may be hinged to the rest of the support structure 973. Such articulation may provide a predictable path for the support member 979 to fold or collapse with the supported electronics leads. Other forms of movable support elements may include support elements that move along tracks in a support structure. In further examples, the support element 979 is biased by a spring mechanism that can reduce backlash (i.e., unwanted movement).

In this illustrated example, only one set of flexible electronic leads 975 is shown for simplicity. It should be understood that another set of electronics leads 975 are provided on the opposite side for the other head, and may include flexible leads, rigid leads, as well as other electronics leads described herein, or other electronics leads as will be selected by one of skill in the art.

It will be appreciated by persons skilled in the art that numerous variations and/or modifications may be made to the above-described embodiments without departing from the broad general scope of the disclosure. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive.