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1. 发明申请

WO2020040639A2 AN ELECTRICAL STIMULATION DEVICE FOR BODY TISSUE 审中-公开
公开(公告)号：WO2020040639A2
公开(公告)日：2020-02-27
申请号：PCT/NL2019/050542
申请日：2019-08-22
申请人： SALVIA BIOELECTRONICS B.V.
发明人： MARTENS, Hubert , SCHOBBEN, Daniël , DRIESSEN, Antonius
摘要： Implantable devices require a protection method, both to protect the body from implant contamination and the implant electronics from corrosion. Encapsulation is a critical component for the design of a medical device implant –it acts as a barrier between the active electronics and the inside of the human body. Currently, bulky feedthroughs and headers must be incorporated in the design of medical devices, such as implantable pulse generators (IPG), to reduce the risk of water ingress. This means that efforts to miniaturize such implantable devices are hindered. An electrical stimulation device is provided comprising a treatment pulse generator unit and an implantable electrode unit; the treatment pulse generator unit being configured and arranged to wirelessly transmit the treatment energy pulses; the implantable electrode unit comprising an electrode unit encapsulation layer, configured and arranged to resist the ingress of fluids from a human or animal body; and being configured and arranged to wirelessly receive at least a portion of the treatment pulsed energy from an associated energy transmitter through the encapsulation layer when the associated energy transmitter is proximate. The electrode unit further comprises one or more stimulation electrodes,and is configured and arranged to be rigidly attached to the treatment pulse generator unit such that one or more energy transmitters are proximate the associated energy transmitter. By providing a separate electrode unit comprising an encapsulation layer and transmitting the signals wirelessly to the electrode unit through the encapsulation layer, the electrode unit may be separately optimized for implantability. In addition, the dimensions of the implantable electrode unit may also be minimized as the functionality is divided between the electrode unit and the pulse generator unit. In addition, the rigid attachment may provide improved retention of alignment and/or proximity –this may improve the stability and reproducibility of the one or more energy transfer channels.

2. 发明申请

WO2022211614A1 IMPROVED EFFICIENCY IN WIRELESS ENERGY CONTROL FOR AN IMPLANTABLE DEVICE 审中-公开
公开(公告)号：WO2022211614A1
公开(公告)日：2022-10-06
申请号：PCT/NL2022/050111
申请日：2022-02-25
申请人： SALVIA BIOELECTRONICS B.V.
发明人： NIJLUNSING, Rutger , MARTENS, Hubert
IPC分类号： A61N1/36 , A61N1/372 , G16H40/67 , A61N1/378 , A61N1/05 , A61N1/14 , A61N1/36003 , A61N1/3605 , A61N1/3606 , A61N1/36062 , A61N1/36071 , A61N1/36125 , A61N1/36128 , A61N1/36146 , A61N1/36175 , A61N1/36192 , A61N1/36196 , A61N1/37252 , A61N1/3787 , G16H40/63
摘要： During charging of implantable devices via inductive coupling, heat may be produced within the implantable device, so control of the charging may be desirable to reduce or avoid the risk of undesirable tissue heating. Exchanging parameters relevant for charging may prevent undesirable heating, but typically increase the complexity of the devices used. An implantable device is provided, for wirelessly receiving energy pulses, monitoring the energy storage, and transmitting a first sufficient energy signal when the energy storage exceeds a first maximum value. An associated energy transmission device is provided, for wirelessly transmitting a plurality of successive energy pulses transmitted at a first power level, pausing energy transmission immediately after the first sufficient energy signal is received, and subsequently resuming energy pulse transmission at the first power level if no further sufficient energy signal is received.

3. 发明申请

WO2020121198A1 AN IMPLANTABLE MEDICAL DEVICE WITH TWO OR MORE ENCAPSULATED COMPONENTS 审中-公开
公开(公告)号：WO2020121198A1
公开(公告)日：2020-06-18
申请号：PCT/IB2019/060625
申请日：2019-12-10
申请人： SALVIA BIOELECTRONICS B.V.
发明人： SCHOBBEN, Daniël , MARTENS, Hubert
IPC分类号： A61N1/375 , A61N1/36
摘要： Implants must protect against implant contamination and corrosion of electronics. However, when electrical components are fitted to flexible substrates, failure can occur at electrical connections. An implant comprises: a flexible substrate; a first and second electrical component at a first and second position, electrically connected through an interconnect layer; a first and second component cover, separately encapsulating the first and second component to resist the ingress of body fluids into the component positions; wherein the flexible substrate allows a relative change in disposition between the first component cover and the second component cover. One or more electrodes are provided at a third position. By encapsulating each component separately, the position of force / tension is moved away from the component attachment position to a point somewhere between the component positions. By disposing one or more electrode away from the components, the ingress is further restricted.

4. 发明申请

WO2021111371A1 IMPLANTABLE STIMULATOR WITH AN ELECTRODE ARRAY AND CONFORMABLE SUBSTRATE 审中-公开
公开(公告)号：WO2021111371A1
公开(公告)日：2021-06-10
申请号：PCT/IB2020/061474
申请日：2020-12-04
申请人： SALVIA BIOELECTRONICS B.V.
发明人： MARTENS, Hubert , SCHOBBEN, Daniël , VAN DER ZALM, Maartje , BOERE, Stijn
IPC分类号： A61B5/00 , A61L31/08 , A61L31/10 , A61N1/36 , A61N1/375
摘要： The use of neurostimulation leads in the craniofacial region is associated with skin erosion and lead migration. The cylindrical shape and associated thickness of state-of-the-art leads results in the lead eroding through the skin or results in the lead being displaced so that the electrodes no longer cover the targeted nerves. An implantable stimulator 1001110 is provided having a substrate 300, 1400 comprising a conformable portion with an electrode array, and a pulse generator 500. A plurality of electrical interconnections 250, 1210 are positioned between the surfaces of the substrate The conformable portion has a thickness equal to or less than 0.5 millimeters. Optionally, one or more encapsulation layers 1300 may be provided. Optionally, one or adhesion layers 1500 may also be provided comprising a ceramic material. By providing a more easily patternable substrate, more complicated electrode array configurations may be supported, allowing a higher degree of flexibility to address transverse and/or longitudinal misalignment. By providing a relatively thin implantable electrode array, user comfort may be increased. The one or more adhesion layers improve the performance of the encapsulation.

5. 发明申请

WO2023026216A1 IMPLANTABLE STIMULATOR WITH AN ELECTRODE ARRAY, CONFORMABLE SUBSTRATE, AND MECHANICAL STRAIN RELIEF 审中-公开
公开(公告)号：WO2023026216A1
公开(公告)日：2023-03-02
申请号：PCT/IB2022/057941
申请日：2022-08-24
申请人： SALVIA BIOELECTRONICS B.V.
发明人： MARTENS, Hubert Cecile Francois , SCHOBBEN, Daniël Willem Elisabeth , VAN DER ZALM, Maartje , BOERE, Stijn
IPC分类号： A61N1/05 , A61N1/36 , A61N1/375 , A61N1/378
摘要： An implantable stimulator has a substrate 300, 1400 comprising a first portion 2010, 2110, 2210, 2310 with a pulse generator 500, and a conformable portion 2020, 2120, 2320 with an electrode array 200, 400, 1220. Electrical interconnections 250, 1210 are provided to the pulse generator with an electrical interface comprising an electrically conductive elastomer 2260. An encapsulation layer 1300, 1310, 1320, 2150, 2250 is provided, configured to resist separation of the conformable portion from the first portion at the meeting of the first and conformable portions. The conformable portion has a thickness equal to or less than 0.5 millimeters. Optionally, a mechanical brace 2140, 2240, 2340 is provided at the meeting of the first and conformable portions to further resist separation. By providing an encapsulant, a conductive elastomer may be used to simplify manufacturing or repair. An ACA elastomer such as ACF provides a high separation resistance to longitudinal forces.

6. 发明申请

WO2021198484A1 AN IMPLANTABLE ELECTRICAL DEVICE COMPRISING A SUBSTRATE, ENCAPSULATION LAYER AND ADHESION LAYER 审中-公开
公开(公告)号：WO2021198484A1
公开(公告)日：2021-10-07
申请号：PCT/EP2021/058751
申请日：2021-04-01
申请人： SALVIA BIOELECTRONICS B.V.
发明人： VAN DER ZALM, Maartje , BOERE, Stijn Willem
IPC分类号： A61B5/00 , A61L31/08 , A61L31/10 , A61N1/36 , A61N1/375 , A61B5/0031 , A61B5/40 , A61B5/686 , A61B5/6861 , A61L2420/08 , A61L31/088 , A61N1/3605 , A61N1/3758
摘要： Implantable devices require protection to protect a human or animal body from implant contamination and to protect implant electrical connections and electronics from corrosion. Although PDMS can be substantially biocompatible, it still has a relatively high permeability to moisture which can lead to degradation of the implant electronics. An implantable electric device is provided comprising: a flexible substrate having one or more electrical conductors and a first surface comprising a Liquid-Crystal Polymer (LCP); a first biocompatible encapsulation layer; a first adhesion layer disposed between the first surface and the first encapsulation layer; wherein: the first adhesion layer comprises a ceramic material; the first encapsulation layer comprises a silicone rubber such as a PDMS, and the first adhesion layer and the first encapsulation layer are configured and arranged to conform to the first surface and to resist the ingress of fluids into at least a portion of the first surface. By providing a bilayer having an encapsulant comprising a silicone rubber and a conformal adhesion layer comprising ceramic materials, the adhesion layer appears to show significantly higher stability in ionic media, thereby providing relatively longer protection in case of any delamination or water permeation through the encapsulant.

7. 发明申请

WO2021044387A1 A METHOD OF OPERATIING AN ELECTRICAL STIMULATION DEVICE WITH TWO OR MORE STIMULATION ENERGY SUPPLIES, AND A STIMULATING DEVICE 审中-公开
公开(公告)号：WO2021044387A1
公开(公告)日：2021-03-11
申请号：PCT/IB2020/058294
申请日：2020-09-06
申请人： SALVIA BIOELECTRONICS B.V.
发明人： SCHOBBEN, Daniël , MARTENS, Hubert , GEE, Stephen Mark , WEIJAND, Koen
IPC分类号： A61N1/36 , A61N1/378 , A61N1/05
摘要： Conventional devices may deliver a degree of electrical charge into biological tissues – to satisfy regulatory and safety concerns, measures are taken to maintain a zero-charge residual at the stimulation site. A physically large capacitor is usually required, making miniaturization more difficult, and increasing the cost as one capacitor is required per electrode. A method for operating tissue stimulation device 100 is provided, the device comprising: a first stimulation electrode 200; a pulse energy controller 500, 510 for transferring electrical energy as one or more electrical stimulation pulses to the first stimulation electrode 200; the pulse energy controller 500, 510 further comprising two or more stimulation energy supplies 601, 602, 603, 604, for each supplying electrical energy substantially concurrently to the first stimulation electrode 200 as a first pulse 526, 527, 528, 529, 530, 531; and each supplying electrical energy separately to the first stimulation electrode 200 as a second pulse 526*, 527*, 528*, 529*, 530*, 531*. A simpler control of stimulation may be provided by considering each energy supply as an energy building block, which may be selected as required. Using power supplies in this way reduces the requirements that they be very accurate and very stable. By requiring less functionality, the size and cost of the power supply design may be reduced. By using the same supplies for different pulses, a higher degree of reproducibility may be provided.

8. 发明申请

WO2020165735A1 AN IMPLANTABLE RESTRAINT AND STIMULATION DEVICE CONFIGURED FOR EXPLANTATION 审中-公开
公开(公告)号：WO2020165735A1
公开(公告)日：2020-08-20
申请号：PCT/IB2020/051034
申请日：2020-02-10
申请人： SALVIA BIOELECTRONICS B.V.
发明人： MARTENS, Hubert , SCHOBBEN, Daniël
IPC分类号： A61N1/05 , A61N1/36 , A61F2/02
摘要： Conventional implantable leads comprise one or more restraints in the form of barbs to reduce the risk of lead migration. However, these barbs make it more difficult to explant (remove) the medical lead. They may also lead to reduced comfort, and often results in the lead protrusions piercing through the skin. An implantable restraint (100, 101, 102) is provided comprising an opening (500), configured to receive a tissue anchor; a pair of protrusions (401, 404), between the opening (500) and a distal edge, providing an anchor resistance to a longitudinal force (610); wherein the pair of protrusions (401, 404) are further configured to separate by a distance approximately equal to the tissue anchor when the longitudinal force (610) exceeds a first predetermined threshold, such that the pair of protrusions (401, 404) moves past the tissue anchor. By providing one or more openings extending through the substrate, the growth of tissue which naturally occurs after implantation is utilized to assist in securing the implantable restraint at the implantation site. By providing the pair of protrusions configured to provide resistance, a high degree of control of the restraining force and the explantation force is provided.

9. 发明申请

WO2020040639A3 AN ELECTRICAL STIMULATION DEVICE FOR BODY TISSUE 审中-公开
公开(公告)号：WO2020040639A3
公开(公告)日：2020-02-27
申请号：PCT/NL2019/050542
申请日：2019-08-22
申请人： SALVIA BIOELECTRONICS B.V.
发明人： MARTENS, Hubert , SCHOBBEN, Daniël , DRIESSEN, Antonius
IPC分类号： A61N1/378 , A61N1/372
摘要： Implantable devices require a protection method, both to protect the body from implant contamination and the implant electronics from corrosion. Encapsulation is a critical component for the design of a medical device implant –it acts as a barrier between the active electronics and the inside of the human body. Currently, bulky feedthroughs and headers must be incorporated in the design of medical devices, such as implantable pulse generators (IPG), to reduce the risk of water ingress. This means that efforts to miniaturize such implantable devices are hindered. An electrical stimulation device is provided comprising a treatment pulse generator unit and an implantable electrode unit; the treatment pulse generator unit being configured and arranged to wirelessly transmit the treatment energy pulses; the implantable electrode unit comprising an electrode unit encapsulation layer, configured and arranged to resist the ingress of fluids from a human or animal body; and being configured and arranged to wirelessly receive at least a portion of the treatment pulsed energy from an associated energy transmitter through the encapsulation layer when the associated energy transmitter is proximate. The electrode unit further comprises one or more stimulation electrodes,and is configured and arranged to be rigidly attached to the treatment pulse generator unit such that one or more energy transmitters are proximate the associated energy transmitter. By providing a separate electrode unit comprising an encapsulation layer and transmitting the signals wirelessly to the electrode unit through the encapsulation layer, the electrode unit may be separately optimized for implantability. In addition, the dimensions of the implantable electrode unit may also be minimized as the functionality is divided between the electrode unit and the pulse generator unit. In addition, the rigid attachment may provide improved retention of alignment and/or proximity –this may improve the stability and reproducibility of the one or more energy transfer channels.

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