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EP-4734825-A1 - BIOELECTRONICS SYSTEM FOR AN IMPLANT DEVICE

EP4734825A1EP 4734825 A1EP4734825 A1EP 4734825A1EP-4734825-A1

Abstract

A bioelectronics system is provided. The bioelectronics system comprises an implant device having multiple pairs of electrodes integrated therein and an implantable control electronics module. The implantable control electronics module comprises: a multiplexer configured to enable a separate signal to be independently applied across each pair of electrodes, a microcontroller, and a wireless communication module. The implantable control electronics module further comprises either: (i) an impedance analyser configured to measure a respective complex impedance across each pair of electrodes, wherein the microcontroller is configured to encode the measured complex impedances as complex impedance information, and the wireless communication module is configured to transmit the complex impedance information to a remote unit for analysis; or (ii) a waveform generator configured to apply respectively determined waveform profiles across each pair of electrodes, wherein the microcontroller is configured to determine the respective waveform profiles to be applied across each pair of electrodes based on instructions received, from a remote unit and by the wireless communication module, to deliver an electrical signal across the multiple pairs of electrodes.

Inventors

  • MERCER, JOHN
  • HOARE, DANIEL
  • NEALE, STEVEN
  • MIRZAI, Nosrat
  • CZYZEWSKI, JAKUB
  • HOLSGROVE, Michael

Assignees

  • The University Court Of The University Of Glasgow

Dates

Publication Date
20260506
Application Date
20240624

Claims (19)

  1. 1 . A bioelectronics system comprising: a vascular implant device having a tissue interface portion that has multiple pairs of electrodes disposed therein; and an implantable control electronics module communicably connectable to the vascular implant device, the control electronics module comprising: a multiplexer configured to independently address each pair of electrodes; an impedance analyser connectable with the multiple pairs of electrodes via the multiplexer and configured to measure a respective complex impedance between each pair of electrodes; a microcontroller configured to encode the measured complex impedances as complex impedance information; and a wireless communication module configured to transmit the complex impedance information to a remote unit for analysis.
  2. 2. The bioelectronics system according to claim 1 , wherein the impedance analyser is configured to measure the respective complex impedances over a range of frequencies.
  3. 3. The bioelectronics system according to claim 1 or 2, wherein the complex impedance information includes a map of the measured complex impedances based on the positions of each pair of electrodes in the implant device.
  4. 4. The bioelectronics system according to any preceding claim, wherein the remote unit is configured to transmit the complex impedance information, and/or analysed complex impedance information to a third-party device.
  5. 5. A bioelectronics system comprising: a vascular implant device having a tissue interface portion that has multiple pairs of electrodes disposed therein; and an implantable control electronics module communicably connectable to the vascular implant device, the control electronics module comprising: a multiplexer configured to independently address each pair of electrodes; a wireless communication module configured to receive instructions to deliver an electrical signal across the multiple pairs of electrodes; a microcontroller configured to determine a respective waveform profile to be applied across each pair of electrodes based on the received instructions; and a waveform generator connectable with the multiple pairs of electrodes via the multiplexer and configured to apply the respectively determined waveform profiles across each pair of electrodes.
  6. 6. The bioelectronics system according to claim 5, wherein the waveform generator includes an amplifier to amplify the signal to a predetermined voltage.
  7. 7. The bioelectronics system according to claim 5 or 6, wherein the one or more waveform profiles are configured to induce apoptosis in cells in the vicinity of the implant device.
  8. 8. The bioelectronics system according to any of claims 5 to 7, wherein the implantable control electronics module is a first implantable control electronics module, and the system further comprises a second implantable control electronics module comprising: a measurement multiplexer configured to independently address each pair of electrodes; an impedance analyser connectable with the multiple pairs of electrodes via the measurement multiplexer and configured to measure a respective complex impedance between each pair of electrodes; a microcontroller configured to encode the measured complex impedances as complex impedance information; and a wireless communication module configured to transmit the complex impedance information to a remote unit for analysis.
  9. 9. The bioelectronics system according to claim 8, wherein one or more of: the multiplexers of the first and second implantable control electronics modules; the microcontrollers of the first and second implantable control electronics modules; and the wireless communication modules of the first and second control electronics modules are common shared components between the first and second control electronics modules.
  10. 10. The bioelectronics system according to any one of claims 5 to 7, wherein the control electronics module further comprises an impedance analyser connectable with the multiple pairs of electrodes via the multiplexer and configured to measure a respective complex impedance between each pair of electrodes, wherein the microcontroller is further configured to encode the measured complex impedances as complex impedance information, and wherein the wireless communication module is configured to transmit the complex impedance information to a remote unit for analysis.
  11. 11. The bioelectronics system according to any one of claims 8 to 10, wherein the impedance analyser is configured to measure the respective complex impedances over a range of frequencies.
  12. 12. The bioelectronics system according to any of claims 8 to 11 , wherein the complex impedance information includes a map of the measured complex impedances based on the positions of each pair of electrodes in the implant device.
  13. 13. The bioelectronics system according to any of claims 8 to 12, wherein the remote unit is configured to transmit the complex impedance information, and/or analysed complex impedance information to a third-party device.
  14. 14. The bioelectronics system according to any preceding claim, wherein the implantable control electronics module further comprises a rectifier configured to receive a wireless transmission and convert the wireless transmission to a direct current signal to power said implantable control electronics module.
  15. 15. The bioelectronics system according to any preceding claim, wherein the implantable control electronics module is contained within a hermetically sealed housing.
  16. 16. The bioelectronics system according to claim 15, wherein the hermetically sealed housing comprises a body made from a radio frequency insulating material, wherein the body comprises a radio frequency window through which signals to or from the wireless communication module are transmissible.
  17. 17. The bioelectronics system according to any preceding claim, wherein the multiple pairs of electrodes consist of an array of interdigitated electrodes.
  18. 18. The bioelectronics system according to any preceding claim, wherein the implant device is an arteriovenous graft.
  19. 19. The bioelectronics system according to any preceding claim, wherein the remote unit is part of a wearable device.

Description

BIOELECTRONICS SYSTEM FOR AN IMPLANT DEVICE Field of the Invention The present invention relates to a bioelectronics system used with an implant device and particularly, although not exclusively, to such systems as applicable to impedance-based analysis and/or electrotherapy using an implantable control electronics module connected to the implant device. Where the implant device is a vascular implant or another transluminal device, e.g. a graft or stent, the bioelectronics system may be used in the detection and prevention of restenosis or thrombosis, for example. Background Chronic kidney disease affects over 843.6 million people worldwide, and is anticipated to be the fifth largest cause of mortality by the year 2040. In the United Kingdom alone, over 60,000 patients suffer from chronic kidney disease and the associated cost of treatment is very high. For example, in the financial year 2009-2010, the National Health Service in England spent almost £1 .5 billion on treatment for patients with chronic kidney disease. A common part of treatment for patients with chronic kidney disease is haemodialysis, a schematic of which is shown in Figure 1 . Figure 1 shows a patient 100 undergoing a haemodialysis treatment via a vascular access region 102. Haemodialysis treatments are typically repeated frequently (often multiple times a week) meaning that treatment lines 104a, 104b are inserted into and removed from the vascular access region 102 on a regular basis. This can cause the vascular access region 102 to deteriorate to the point that it is no longer possible to find viable blood vessels that the treatment lines 104a, 104b can be inserted into. For this reason, arteriovenous fistulas (AVFs) and arteriovenous grafts (AVGs) are often created or inserted into the vascular region 102 of the patient to provide a long-lasting vascular access point for the treatment lines 104a, 104b. AVFs are formed by connecting an artery 106 of the patient 100 to a nearby vein 108. The AVF has a large surface area to allow for repeated cannulation with the treatment lines 104a, 104b. However, AVFs suffer from high clotting and infection rates, and when using an AVG the patient is able to undergo haemodialysis treatment immediately after the AVG is installed, while they must wait several weeks for an AVF to mature so as to be useable in haemodialysis treatment. For this reason, it may be considered preferable to use AVGs. AVGs may be inserted by connecting the artery 106 of the patient 100 to a nearby vein 108 using a graft 110. However, AVGs (as illustrated in Figure 2) typically require regular maintenance over the implant’s lifetime because they are highly susceptible to both vascular restenosis (vessel narrowing), and thrombosis (blood clotting). As can be seen from Figure 2, the implantation of the arteriovenous graft 110 requires the application of one or more sutures 112. The suturing of the graft 110 to the blood vessels 106, 108 of the patient 100 leads to a wound response in the form of neointimal hyperplasia through the migration and proliferation of smooth muscle cells 114 from the tunica media 116 (vessel wall) of the blood vessel 104, 106 to an interior luminal surface of the graft 110 due to the removal of endothelial cells in the tunica intima. The proliferation of these smooth muscle cells 114 causes the lumen (channel) of the graft 100 to remodel and narrow - i.e. , vascular restenosis. Over time, this restenosis can initiate the formation of a clot 118 that further reduces and, eventually, entirely cuts off the flow through the graft 110. This restenosis and thrombosis of AVGs 110 is the leading limitation in their wider implantation as up to 50% of all AVGs require intervention within one year of implantation to reverse the effects of vascular restenosis. Intervention is both costly and risky as all surgery carries inherent risks. Moreover, the constant monitoring of AVGs to check for the effects of vascular restenosis is usually only carried out in a hospital environment at irregular intervals. This is therefore a suboptimal solution for the monitoring of AVG performance. Meanwhile, human disease caused by blocked blood vessels are responsible for significant human suffering and contribute to a global economic health burden. Vascular pathologies initiated by blood clotting or other tissue-wound responses are a leading cause in heart attacks, strokes, and peripheral vascular diseases. As with arteriovenous grafts, the monitoring and treatment of occluded blood vessels is costly, inefficient, and risky. There is therefore a need to provide an improved system and methodology for monitoring and treating the occlusion of implants, particularly vascular implants. The present invention has been devised in light of the above considerations. Summary of the Invention In a general sense, the present invention provides a bioelectronics system that, by virtue of the independent activation of electrodes within an implanted d