Abstract
Disclosed herein is an implantable device (10) configured for implantation in a body of subject (50), the device comprising: a flexible body (20) and at least one stimulator unit (30) attached to the flexible body (20), wherein the at least one stimulator unit (30) comprises a plurality of electric components (31) encapsulated in a hermetically sealed enclosure (32), a receiving antenna (33), and at least one electric conductor (34) in electrical connection with the plurality of electric components (31).
Claims
1. An implantable device configured for implantation in a body of subject, the implantable device comprising: a flexible body and at least one stimulator unit attached to the flexible body, wherein the at least one stimulator unit comprises: a plurality of electric components encapsulated in a hermetically sealed enclosure, a receiving antenna, and at least one electric conductor in electrical connection with the plurality of electric components.
2. The implantable device according to claim 1, wherein the at least one stimulator unit is leadless.
3. The implantable device according to claim 1, wherein the flexible body at least partly consists of silicone.
4. The implantable device according to claim 1, wherein the flexible body comprises suture holes for connecting the implantable device to a tissue of a subject.
5. The implantable device according to claim 1, wherein the implantable device is configured for implantation proximal to a genioglossus muscle in the vicinity of a hypoglossal nerve of the subject.
6. The implantable device according to claim 1, wherein the flexible body has a first arm and a second arm, wherein each arm comprises at least one suture hole.
7. The implantable device according claim 6, wherein each arm of the flexible body has at least one stimulator unit attached to it.
8. The implantable device according to any of the claim 1, wherein the receiving antenna is configured to receive power signals and stimulation signals from a transmitting antenna located outside the subject's body via inductive coupling between the transmitting antenna and the receiving antenna.
9. The implantable device according to claim 1, wherein the stimulator unit comprises at least one electrical circuit for electrically connecting the plurality of passive electrical components to the at least one electric conductor.
10. The implantable device according to claim 1, wherein the at least one stimulator unit comprises a main body.
11. The implantable device according to claim 10, wherein the receiving antenna is disposed in the main body.
12. The implantable device according to claim 10, wherein the stimulator unit comprises a cap disposed on a first surface of the main body, forming the hermetically sealed enclosure.
13. The implantable device according to claim 11, wherein the cap is at least partly made from titanium.
14. The implantable device according to claim 12, wherein the first surface of the stimulator unit comprises a welding projection, wherein the cap is weldable to the welding projection.
15. The implantable device according to claim 12, wherein the stimulation unit comprises a plurality of solder pads disposed on the first surface of the stimulation unit and located in the hermetically sealed enclosure, wherein the solder pads are configured for mounting the plurality of electric components.
16. The implantable device according to claim 15, wherein the plurality of electric components is soldered to the plurality of solder pads.
17. The implantable device according to claim 10, wherein the at least one electric conductor is disposed on a second surface of the main body.
18. The implantable device according to claim 10, wherein the at least one electric conductor is formed as an electrode pad.
19. The implantable device according to claim 10, wherein the main body of the stimulation unit at least partly consists of a ceramic material.
20. The implantable device according to claim 19, wherein the main body of the stimulation unit further comprises a platinum layer (PL).
21. The implantable device according to claim 19, wherein the ceramic material of the main body is sintered.
22. The implantable device according to claim 10, wherein the receiving antenna has at least a circular shape or a coiled shape and is confined to an outer annular area of the main body of the stimulation unit.
23. The implantable device according to claim 10, wherein the hermetically sealed enclosure and the at least one electric conductor are located within an inner circular area of the main body of the stimulation unit.
24. The implantable device according to claim 1, wherein the at least one stimulator unit further comprises: at least one processor configured to perform a logic operation; and at least one electric battery.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several examples of the disclosed subject matter. The drawings depicts the following:
[0025] FIG. 1 depicts a schematic view of an implantable device according to an exemplary embodiment;
[0026] FIG. 2 depicts a schematic view of an implantable device according to an alternative embodiment;
[0027] FIG. 3 depicts a schematic cross-sectional view of a stimulator unit according to an exemplary embodiment;
[0028] FIG. 4 depicts a schematic top-view of the stimulator unit according to the embodiment shown in FIG. 3;
[0029] FIG. 5 depicts a schematic bottom-view of the stimulator unit according to the embodiment shown in FIG. 3 or FIG. 4.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0030] FIG. 1 depicts a schematic view of an implantable device 10 according to an exemplary embodiment. The drawing illustrates an implantable device 10 being attached to a genioglossus muscle 51 of a subject 50. This way, nerves associated with the genioglossal muscle 51 can be modulated, resulting in a stimulation of the subject's 50 tongue. The implantable device 10 as shown in FIG. 1 comprises a flexible body 20 and two stimulators 30 (or microstimulators) unit attached to the flexible body 20, wherein one stimulator unit 30 is attached to a first arm 201 of the flexible body 20 and the other stimulator unit 30 is attached to a second arm 202 of the flexible body 20. The flexible body 20 allows for accurate fitting of the device 10 to the desired tissue. For example, the implantable device 10 according to FIG. 1 is mounted to the genioglossal muscle 51 in a saddle-like shape. This eliminates the need for additional anchorage. Each stimulator unit comprises a receiving antenna 33, a plurality of passive electrical components 31 encapsulated in a hermetically sealed enclosure 32. Furthermore, each stimulator unit 30 comprises at least one electric conductor 34 in electrical connection with the plurality of passive electric components 31. Also, the stimulator units 30 comprise an electrical circuit 35 (not shown) for electrically connecting the receiver antenna 33 to the plurality of passive electrical components 31 and back to the at least one pair of electrodes 34. The stimulator units 30 as depicted in FIG. 1 are of essentially lenticular shape and have a dome-shaped cap 321 attached on a first surface 41 of a main body 40 of the stimulator unit 30. The space encapsulated by the cap 321 is regarded the hermetically sealed enclosure 32 comprising the passive electrical components 31, which are not shown in FIG. 1. With a device 10 as described above, each of stimulator units 30 may be controlled separately, or both simulator units 30 may be controlled simultaneously. This allows for either a singular (unilateral) or a bilateral stimulation of the muscle 51, depending on the chosen treatment.
[0031] Having two stimulator units 30, as is the case with the implantable device 10 shown in FIG. 1, allows for more advanced stimulation strategies, since the tissue to be stimulated may be stimulated from at least two different sites. Preferably, the two stimulator units 30, i.e. the first arm's 201 stimulator 30 and the second arm's 202 stimulator 30, may be configured to operate independently. This way, the amount of possible stimulation strategies that can be applied to the subject 50 is increased. According to a preferred embodiment shown in FIG. 1, the implantable device 10 is configured in such a way that the two stimulator units 30 are positioned opposite of each other when the flexible body 20 is attached to the muscle tissue 51. Operation of such an “intelligent” stimulation, i.e. of an implantable device 30 having at least two independent stimulator units 30, may be controlled by a processor, which may for example be located external to the subject's 50 body.
[0032] Each stimulator unit comprises a receiving antenna 33, which, in case of the embodiment depicted in FIG. 1, is formed as a circular coil antenna 33. The antenna 33 is configured to receive power signals and stimulation signals from a transmitting antenna (not shown) located outside the subject's 50 body via coupling between the transmitting antenna and the receiving antenna 33. Said coupling of the receiving antenna 30 and an external transmitting includes any interaction between the receiving antenna 33 and the transmitting antenna that causes a signal on the receiving antenna 33 in response to a signal applied to the transmitting antenna. The coupling between the antennas may include capacitive coupling, inductive coupling, radio frequency (RF) coupling and any combinations thereof. According to FIG. 1, the receiving antenna 33 is integrated in the main bodies 40 of the stimulator units 30.
[0033] According to the above, the stimulator units 30 shown in FIG. 1 are leadless and consist of only few parts. The lack of lead wires drastically minimalizes the number of parts being subjected to stress and/or fatigue, since lead wires they can be damaged over time as a result of the movement of the stimulated muscle. Thus, the stimulator units 30 of FIG. 1 are highly durable and allow for accurate nerve stimulation, while reliably staying in a desired position with respect to the tissue to be stimulated.
[0034] The first arm 201 and second arm 202 further facilitate attachment of the implantable device 10 to the desired muscle tissue, since they enable the flexible body 20 to conform at least partially around soft or hard tissue beneath a patient's skin. The flexible body 20 has several suture holes 21 for attaching the implantable unit 10 to the muscle tissue. This way, the flexible body of the implantable device may be attached in a desired manner. With the suture holes 21 placed on the first arm 201 and the second arm 202 of the flexible body 20, the implantable device 10 may be secured more conformingly, thus keeping the stimulator units 30 of the implantable device 10 in their required positions.
[0035] The device 10 as shown in FIG. 1 allows for an easy and stable positioning of the stimulator units 30 in a subject 50, patient or recipient of the stimulation, e.g. around a muscle 51 of the subject 50. The flexible body 20 may be formed from any suitable, biocompatible material such that it may be configured to conform to a desired location. The material of the flexible body 20 may preferably consist of silicone.
[0036] FIG. 2. depicts a schematic view of an implantable device 10 according to an alternative embodiment. While being in principle identical to the embodiment shown in FIG. 1, the embodiment depicted in FIG. 2 differs in that all components of the stimulator units 30 are encapsulated in the hermetically sealed enclosure 32, with the exception of the electrode pairs 34, which are disposed on the outside of the enclosure 32 for the application of a stimulation current. Furthermore, the stimulator units 30 are of tubular shape. As is the case with the stimulator units 30 shown in FIG. 1, the stimulator units 30 shown in FIG. 2 are leadless and consist of only few parts. Thus, they are not subjected to fatigue.
[0037] FIG. 3, FIG. 4 and FIG. 5 depict a stimulator unit 30 according to an exemplary unit. More specifically, FIG. 3 shows a schematic cross-sectional view, FIG. 4 shows a schematic top-view and FIG. 5 shows a schematic bottom-view of the stimulator unit 30. The depicted stimulator unit 30 comprises a main body 40 that is substantially made from one or more ceramic layers, on which a platinum layer is deposited before the ceramic is sintered. As shown in FIG. 3, FIG. 4 and FIG. 5, the coiled receiving antenna 33 and the electrical circuit 35 are integrated within the ceramic main body 40 of the stimulator unit 30. That way, the receiving antenna 33 and the electronic circuit 35 may be permanently fixed in the main body 40, avoiding unnecessary movement of intricate parts. The electrical circuit 35 electrically connects the receiver antenna 33 to the plurality of passive electrical components 31 and back to the at least one electric conductor 34. The circuit 35 may include conductive materials, such as gold, platinum, titanium, or any other biocompatible conductive material or combination of materials. Furthermore, the circuit 35 may include one or more of the following components: resistor, inductor, and/or capacitor. The various passive components may be used to connect the passive components least one electric conductor. As shown in FIG. 4 and FIG. 5, the coiled antenna 33 is confined to an outer annular area 43 of the stimulation unit 30, thus increasing its efficiency.
[0038] The stimulator unit 30 further comprises a cap 321 attached to a first surface 41 (top side) of the main body 40. The cap 321, which according to the embodiment depicted in FIG. 3 is domeshaped and made from a material comprising titanium, encapsulates the hermetically sealed enclosure 32. The hermetically sealed enclosure 32 comprises the passive electrical components 31, which are preferably reflow soldered onto a plurality of solder pads 311. The wall of the cap 321 should be very thin, preferably less than 10 microns, as to absorb potential stress rather than to transfer it to the ceramic main body 40. According to the embodiment shown in FIG. 3, FIG. 4 and FIG. 5, the cap 321 is welded to the first surface 41 of the main body 40 using an annular welding projection 322 disposed on the first surface 41 of the main body 40. The welding projection 322 and the solder pads 311 are made from any biocompatible material, such as indium, gold-tin etc. The welding projection 322, the hermetically sealed enclosure 32 as well as the passive components 31 present therein are located within an inner circular area 44 of the stimulation unit 30, which essentially lies inside the outer annular area 43.
[0039] As further depicted in FIG. 3, the stimulator unit 30 comprises a electric conductor 34 attached to a second surface 42 (bottom side) of the main body 40. Like the welding projection 322, the hermetically sealed enclosure as well as the passive components 31, the electric conductor 34 is also confined to the inner circular area 44 of the stimulation unit 30. According to a preferred embodiment as well as shown in FIG. 5, the electrodes 34 attached to the second surface of the microstimulator 30 are formed as electrode pads 341.
[0040] The invention is not limited to one of the embodiments described herein but may be modified in numerous other ways.
[0041] All features disclosed by the claims, the specification and the figures, as well as all advantages, including constructive particulars, spatial arrangements and methodological steps, can be essential to the invention either on their own or by various combinations with each other.
LIST OF REFERENCE NUMERALS
[0042] 10 Implantable device [0043] 20 Flexible body [0044] 21 Suture holes [0045] 201 First arm [0046] 202 Second arm [0047] 30 Stimulator unit [0048] 31 Plurality of electrical components [0049] 311 Plurality of solder pads [0050] 32 Hermetically sealed enclosure [0051] 321 Cap [0052] 322 Welding projection [0053] 33 Receiving antenna [0054] 34 Electric conductor [0055] 341 Electrode pad [0056] 35 Electrical circuit [0057] 40 Main body [0058] 41 First surface [0059] 42 Second surface [0060] 43 Outer annular area [0061] 44 Inner circular area [0062] 50 Subject [0063] 51 Genioglossus muscle
