US-12623085-B2 - Implantable neuro modulator device and system comprising such an implantable neuro modulator device

Abstract

An implantable neuro-modulator device, including a hermetically sealed housing, wherein an antenna for communicating with external devices and/or for wirelessly receiving electrical energy is positioned within the housing, wherein a major part of the housing is electromagnetically transparent to radiation in the frequency range below 20 MHz, in particular between 5 and 15 MHz.

Inventors

• Marc Possover

Assignees

• NEUROGYN AG

Dates

Publication Date

20260512

Application Date

20250411

Claims (20)

1. 1 . Implantable neuro-modulator device, comprising a hermetically sealed housing ( 2 ), wherein an antenna ( 19 ) for communicating with external devices and/or for wirelessly receiving electrical energy is positioned within the housing ( 2 ), wherein a major part of the housing ( 2 ) is electromagnetically transparent to radiation in the frequency range below 20 MHz, wherein the housing ( 2 ) has a round cross section, and comprises a first housing part ( 3 ) and a second housing part ( 4 ), wherein the first housing part ( 3 ) comprises a container ( 12 ) with a round cross section which is closed at one end ( 13 ) and has a first sealing ring ( 14 ) at the opposite or second end.
2. 2 . Neuro-modulator device according to claim 1 , wherein the electromagnetically transparent part of the housing is made from plastics, resin, glass, ceramics or a combination thereof.
3. 3 . Neuro-modulator device according to claim 1 , wherein the container ( 12 ), together with the closed end ( 13 ), are machined from a monolithic piece of material.
4. 4 . Neuro-modulator device according to claim 1 , wherein the second housing part ( 4 ) comprises a second sealing ring ( 16 ) and a feed-through element ( 17 ), the feed through element ( 17 ) comprising at least one opening ( 18 ) in which an electrical contact element ( 11 ) may electrically connect one side of the feed-through element ( 17 ) with a second side of the feed-through element ( 17 ).
5. 5 . Neuro-modulator device according to claim 4 , wherein the contact element ( 11 ) is electrically connected to an electrode lead ( 9 ) for outputting modulation pulses to a patient.
6. 6 . Neuro-modulator device according to claim 1 , comprising an overmold ( 5 ) including a molded header ( 6 ) made of biocompatible polymeric resin, the molded header ( 6 ) covering at least parts of the electrical contact element ( 11 ) and the respective openings ( 18 ) in the feed-through element ( 17 ) on one side of the feed-through element ( 17 ).
7. 7 . Neuro-modulator device according to claim 6 , wherein the overmold ( 5 ) comprises at least one opening and/or suture hole for autologous fixation of the device and/or for suturing the device to tissue or bone material.
8. 8 . Neuro-modulator device according to claim 6 , wherein an end portion of the molded header ( 6 ), opposite to the second housing part ( 4 ), comprises a guide member ( 8 ) for guiding an electrode lead ( 9 ), wherein the guide member ( 8 ) is formed at an angle with respect to a longitudinal axis (L) of the housing ( 2 ).
9. 9 . Neuro-modulator device according to claim 6 , wherein the overmold ( 5 ) is covering the entire first and second housing part ( 3 , 4 ) and further forming a molded header ( 6 ) and/or a fixation wing ( 7 ).
10. 10 . Neuro-modulator device according to claim 9 , wherein the fixation wing ( 7 ) is formed at an end of the housing ( 2 ), either adjacent to the first housing part ( 3 ) or opposite to the molded header ( 6 ) and the electrode lead ( 9 ).
11. 11 . Neuro-modulator device according to claim 9 , wherein the fixation wing ( 7 ) is formed in a plane parallel to a longitudinal axis (L) of the housing ( 2 ) in the same or parallel plane as the electrode lead ( 9 ) within the guide member ( 8 ).
12. 12 . Neuro-modulator device according to claim 1 , wherein a diameter-to-length ratio of the housing's maximum diameter to the length of the housing ( 2 ) is less than 0.35.
13. 13 . Neuro-modulator device according to claim 1 , wherein the housing ( 2 ) has a maximum diameter of less than 12 mm.
14. 14 . Neuro-modulator device according to claim 1 , wherein additionally at least one antenna ( 19 ), one rechargeable energy storage device ( 20 ) and one electrical control unit and a pulse generating means are arranged within the housing ( 2 ).
15. 15 . Neuro-modulator device according to claim 1 , wherein a support member ( 21 ) extends essentially over an entire length and an entire width of an internal space confined by the housing ( 2 ) at a certain eccentric height-level of the housing ( 2 ), dividing the space confined by the housing into a first, smaller and second, larger cavity ( 22 , 23 ) of the housing ( 2 ), each one defined by parts of the housing ( 2 ) and one side of the support member ( 21 ), respectively.
16. 16 . Neuro-modulator device according to claim 14 , wherein the at least one rechargeable energy storage device ( 20 ) is/are placed in a second, larger cavity ( 23 ) of the housing ( 2 ).
17. 17 . Neuro-modulator device according to claim 1 , wherein the at least one antenna ( 19 ) is designed as a large aperture antenna with a receiving cross section of more than 0.1*A*B, A being the length of the housing and B being the width or diameter of the housing.
18. 18 . Implantable neuro-modulator device, comprising a hermetically sealed housing ( 2 ), wherein an antenna ( 19 ) for communicating with external devices and/or for wirelessly receiving electrical energy is positioned within the housing ( 2 ), wherein a major part of the housing ( 2 ) is electromagnetically transparent to radiation in the frequency range below 20 MHz, wherein the length of the housing ( 2 ) is less than 50 mm.
19. 19 . Neuro-modulator device according to claim 18 , wherein the housing ( 2 ) has a round cross section, and comprises a first housing part ( 3 ) and a second housing part ( 4 ), wherein the first housing part ( 3 ) comprises a container ( 12 ) with a round cross section which is closed at one end ( 13 ) and has a first sealing ring ( 14 ) at the opposite or second end.
20. 20 . Neuro-modulator system comprising an implantable neuro-modulator device ( 1 ) comprising a hermetically sealed housing ( 2 ), wherein an antenna ( 19 ) for communicating with external devices and/or for wirelessly receiving electrical energy is positioned within the housing ( 2 ), wherein a major part of the housing ( 2 ) is electromagnetically transparent to radiation in the frequency range below 20 MHz, and a wearable and/or handheld electronic device ( 31 ), wherein the wearable and/or handheld electronic device ( 31 ) comprises an energy storage device and a communication interface for establishing a communication connection with the neuro-modulator device ( 1 ).

Description

BACKGROUND OF THE INVENTION The current invention relates to an implantable neuro modulator device and a system comprising an implantable neuro modulator device. It is already known from the prior art to use implantable devices for stimulating muscles for externally triggered muscle contraction, especially in pacemaker devices, such as a cardiac pacemakers or other pacemakers. For those applications an implantable device comprising an energy storage device, and respective electronics for energy management and also for creating and outputting electric trigger impulses to an output port which in turn is connected to an electrode lead are known. The state of the art already teaches pacemaker devices which can be recharged with electrical energy wirelessly. Also the transmission of control data, especially control parameters via a wireless connection, is known from the prior art of pacemakers. The field of neuro modulator devices comprises different types of implantable devices. The implantable neuro modulator devices are used to provide stimulus to nerves, especially via electric pulses, for example in the pelvic region. Accordingly, the implantable neuro modulator devices do not directly cause a physical response by the patient body, such as the contraction of a muscle. However, in the rather young medical field of neuro modulation, it has been found that a lot of pathologic physical conditions of the body of a patient can be relieved or even cured based on the modulation of nerves by implantable new modulator devices. Those conditions include but are not limited to the treatment of erectile dysfunction, fecal incontinence, decubitus and paraplegics. There are further very strong indicators that also psychological indications, such as depression, can be treated and/or cured by neuro modulation of nerves. Even though a muscle stimulation by a pacemaker and the modulation of a nerve are based on the same principle of an electric impulse provided by a preferably implanted device, the different applications as well as technical and medical requirements resulting from those applications differ significantly between the field of muscle stimulation and nerve modulation. Previously, the implantation of neuro modulator devices was generally limited by two basic restrictions. First of all, the surgical methods and procedures to implant a neuro modulator device into a body were rather complicated and required very high skills of the respective surgeon. Additionally, the neuro modulator devices known from the prior art rather uncomfortable to the user, especially due to their size. When implanted into certain parts of the body of a user an implant can be felt or recognized by a user during body movement or even without movement when the implant exceeds a certain volume or size. This is at east uncomfortable to the user/patient bur may also cause pain and/or inflection. SUMMARY OF THE INVENTION Based on this prior art it is the objective of the current invention to suggest an implantable neuro modulator device and a system comprising such an implantable neuro modulator device which allow easy implantation or which are especially adopted to simple implantation procedures and which is more comfortable for the user after implantation. These problems are solved by an implantable neuro modulator device as well as a neuro modulator system as disclosed herein. Preferred embodiments of the claimed invention are provided by the dependent claims, the following description especially the drawings, the description of the drawings and the general description. All aspects or features which are hereinafter disclosed or described as device features shall also be considered to be disclosed as part of respective methods and shall also be claimable as methods, and vice versa. The implantable neuro modulator device according to the current invention comprises a hermetically sealed housing wherein an antenna for communicating with external devices and/or for wirelessly receiving electrical energy is positioned within the housing, wherein a major part of the housing is electromagnetically transparent to radiation in the frequency range below 20 MHz, in particular between 5 and 15 MHz. To lower the amount of surgical procedures for a longtime or long-term use of implantable neuro modulator devices it is important to be able to recharge the electrical energy storage device wirelessly and/or to be able to adapt the use of the neuro modulator device to the patient's needs wirelessly, i.e. without additional surgical procedures. Although devices are known, which enable electromagnetic communication and/or electromagnetic energy transfer, those devices previously had the housing made up of generally at least two major parts, one of which was electromagnetically transparent and the other one was electromagnetically opaque. This known setup comes with two major drawbacks. First of all, the housing becomes rather bulky and space consuming. Secondly, th