WO2023225715A1 - Appareil et procédé de transmission d'énergie et de données à travers la peau à des dispositifs médicaux implantables - Google Patents
Appareil et procédé de transmission d'énergie et de données à travers la peau à des dispositifs médicaux implantables Download PDFInfo
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- WO2023225715A1 WO2023225715A1 PCT/AU2023/050441 AU2023050441W WO2023225715A1 WO 2023225715 A1 WO2023225715 A1 WO 2023225715A1 AU 2023050441 W AU2023050441 W AU 2023050441W WO 2023225715 A1 WO2023225715 A1 WO 2023225715A1
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- WIPO (PCT)
- Prior art keywords
- external
- implanted
- transformer
- patient
- assist device
- Prior art date
Links
- 238000000034 method Methods 0.000 title claims abstract description 21
- 210000000988 bone and bone Anatomy 0.000 claims abstract description 16
- 230000001939 inductive effect Effects 0.000 claims abstract description 6
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- 239000008280 blood Substances 0.000 description 15
- 210000004369 blood Anatomy 0.000 description 15
- 230000005540 biological transmission Effects 0.000 description 12
- 230000002861 ventricular Effects 0.000 description 8
- 239000000560 biocompatible material Substances 0.000 description 6
- 208000015181 infectious disease Diseases 0.000 description 5
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- 238000004891 communication Methods 0.000 description 3
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- 238000001914 filtration Methods 0.000 description 2
- 239000007943 implant Substances 0.000 description 2
- 230000004054 inflammatory process Effects 0.000 description 2
- 230000035515 penetration Effects 0.000 description 2
- 239000002861 polymer material Substances 0.000 description 2
- 238000012421 spiking Methods 0.000 description 2
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- 231100000827 tissue damage Toxicity 0.000 description 2
- 208000035143 Bacterial infection Diseases 0.000 description 1
- 229910000640 Fe alloy Inorganic materials 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
- A61M60/183—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices drawing blood from both ventricles, e.g. bi-ventricular assist devices [BiVAD]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/871—Energy supply devices; Converters therefor
- A61M60/873—Energy supply devices; Converters therefor specially adapted for wireless or transcutaneous energy transfer [TET], e.g. inductive charging
-
- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
- H02J50/10—Circuit arrangements or systems for wireless supply or distribution of electric power using inductive coupling
-
- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J50/00—Circuit arrangements or systems for wireless supply or distribution of electric power
- H02J50/80—Circuit arrangements or systems for wireless supply or distribution of electric power involving the exchange of data, concerning supply or distribution of electric power, between transmitting devices and receiving devices
-
- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J7/00—Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries
- H02J7/00032—Circuit arrangements for charging or depolarising batteries or for supplying loads from batteries characterised by data exchange
- H02J7/00034—Charger exchanging data with an electronic device, i.e. telephone, whose internal battery is under charge
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3507—Communication with implanted devices, e.g. external control
- A61M2205/3523—Communication with implanted devices, e.g. external control using telemetric means
-
- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02J—CIRCUIT ARRANGEMENTS OR SYSTEMS FOR SUPPLYING OR DISTRIBUTING ELECTRIC POWER; SYSTEMS FOR STORING ELECTRIC ENERGY
- H02J2310/00—The network for supplying or distributing electric power characterised by its spatial reach or by the load
- H02J2310/10—The network having a local or delimited stationary reach
- H02J2310/20—The network being internal to a load
- H02J2310/23—The load being a medical device, a medical implant, or a life supporting device
Definitions
- the present invention relates to an apparatus and method for transmitting power and/or data between external and internal components of implantable medical devices.
- the invention is particularly adapted for use in relation to implantable heart assist devices, however it is to be appreciated that the invention has broader application in relation to other implantable medical devices.
- Heart assist devices commonly referred to as ventricular assist devices (VADs) are mechanical circulatory support devices used in the management of advanced heart failure. Such devices are increasingly being used as the number of heart failure patients continues to rise and the number of available donor organs does not meet this need.
- VADs ventricular assist devices
- Heart assist devices used presently include Left Ventricular Assist Devices or LVADs, which use an implantable blood pump that supports the left side of the heart only and Bi-Ventricular Assist Devices or BIVADs, which use two implantable blood pumps that support both sides of the heart.
- LVADs Left Ventricular Assist Devices
- BIVADs Bi-Ventricular Assist Devices
- the one or more blood pumps of heart assist devices are powered either electrically or pneumatically.
- Heart assist devices including one or more implantable, electrically powered blood pumps typically require constant power in the order of about 5 to 25 Watts to maintain safe and effective functioning.
- Heart assist devices including electrically powered blood pumps can include an implanted control module or an external control module or a control module that is distributed between an implanted module and an external module.
- Such systems also typically include one or more power sources such as an external rechargeable battery or an implanted rechargeable battery, or both.
- Percutaneous leads are prone to causing infection in the tissue surrounding the penetration site. Any movement of the percutaneous lead relative to the tissue surrounding the penetration site can cause the wound site to become inflamed or to release bodily fluids such as blood or pus which can be a medium for bacterial infection.
- the wound sites are often large to fit a necessarily large cannula and/or multiple leads, which further complicates healing of the tissue at the wound site and increases infection risk.
- the present invention relates to an apparatus and method for transmitting power and preferably data to a heart assist device implanted within the body of a patient.
- the present invention provides an apparatus for providing power to a heart assist device implanted within the body of a patient, the apparatus including: a core transformer for rigid attachment to a bone site of a patient, a primary coil of the transformer located externally for electrical connection to external components of a heart assist device; and a secondary coil of the transformer located internally for electrical connection to internal components of the heart assist device, wherein the primary coil is connected to an external power source for inducing a voltage in the secondary coil to power the internal components of the heart assist device.
- the core transformer is rigidly attached to the iliac crest of the patient.
- the core transformer is rigidly attached to a rib of the patient.
- Embodiments of the invention are advantageous in that they reduce any movement of part of the implanted power transmission apparatus that penetrates the skin of the patient. Therefore risks of inflammation and infection of surrounding tissue are ameliorated, as are other complications that may arise from movement of existing percutaneous leads.
- the core transformer includes an implanted core member that is implanted, at least in part, internally within the patient and an external core member that is located externally of the patient.
- the implanted core member includes a pair of legs interconnected by a transverse web, wherein the legs pass through the skin of the patient and the web is rigidly secured to the bone.
- the external core member includes a pair of legs interconnected by a transverse web, wherein the legs of the implanted core member are configured for reversible attachment with respectively opposite legs of the external core member to thereby form a completed toroidal or ringshaped transformer core.
- the legs of the implanted and external core members are coupled by a threaded connection therebetween.
- the secondary coil is comprised of an electrically conductive material that is wound around the web of the implanted core member.
- the primary coil winds around the web of the external core member.
- the primary coil is preferably configured to include a latch for attaching and detaching the primary coil from the web of the external core member.
- the primary coil is pivotally attached to the external core member. Pivotal attachment of the primary coil is advantageous as it permits some relative movement of the external primary coil relative to the core of the transformer which in turn is rigidly attached to the bone site.
- the core transformer is rigidly connected to a base that is configured for direct, rigid attachment to the iliac crest or to a rib of the patient.
- the base includes one or more apertures for receiving a one or more bone screws.
- the invention provides a method for providing power to a heart assist device implanted within the body of a patient, the method including: rigidly attaching a core transformer to a bone site of a patient, locating a secondary coil of the transformer internally and electrically connecting the secondary coil to implanted components of a heart assist device, locating a primary coil of the transformer externally and electrically connecting the second coil to external components of the heart assist device; and supplying power to the primary coil thereby inducing a voltage in the secondary coil for powering the internal components of the heart assist device
- supplying power to the primary coil includes providing an alternating current to the primary coil located externally and thereby inducing a voltage in the secondary coil located internally.
- the method includes transmitting data between the implanted and the external components of the heart assist device.
- data is transmitted by amplitude modulation of a signal between the primary coil and the secondary coil.
- data is transmitted by causing temporary variations in load impedance between the primary coil and the secondary coil.
- data is transmitted by frequency shift keying between the primary coil and the secondary coil.
- the invention provides methods for transmitting electrical power and data between external and internal components of the ventricular assist device.
- the method includes transferring electrical power and data from an external control module to an internal control module by providing an alternating current to a primary coil, located externally, and inducing a voltage in a secondary coil, located internally.
- amplitude modulation of a signal is used to transfer data across a core transformer from the primary coil, located externally, to the secondary coil, located internally.
- the alternating current (AC) power induced in the secondary coil is rectified and converted to direct current (DC) to power the internal components of the heart assist device.
- DC direct current
- the signals received at the primary coil or the secondary coil are filtered and processed to provide data to the respective internal or external control module.
- FIGS 1 to 5 are diagrammatic illustrations of the power and data transmission apparatus for use connection with a heart assist device, in accordance with embodiments of the invention, the apparatus include a core transformer affixed to a base for attachment to a bone site of a patient, a primary coil located externally, a secondary coil located internally, external and internal control modules and power sources and internal components of a heart assist device;
- Figure 6 is a schematic illustration of the power and data transmission apparatus of Figures 1 to 5.
- Figure 7 is a diagrammatic illustration of amplitude modulation for encoding and transmitting data in binary 1 -0 at a frequency of about 1 MHz between the external and internal control modules.
- Figure 8 is a diagrammatic illustration of load spiking for encoding and transmitting data in binary 1 -0 at a frequency of about 1 MHz between the external and internal control modules.
- the invention relates to a power and preferably also a data (signal) transmission apparatus 1 adapted to transmit electrical energy and/or data between external and implanted components of a heart assist device 100.
- the power and data transmission apparatus 1 is adapted to transmit electrical energy across the skin of a patient 50 to power a heart assist device 100.
- the apparatus 1 includes a transformer 10 consisting of an external coil 20, an internal coil 40, wherein the transformer is connected to a base member 32 that is rigidly secured to bone below the skin of the patient 50.
- the heart assist device 100 comprises one or more blood pumps 102, 104, a controller which includes an external control module 110 and/or an implanted control module 130 for controlling operation of the one or more blood pumps 102, 104 and a power source which includes an external power source or battery 120 and/or an internal power source or battery 140.
- Each embodiment of the invention described herein and illustrated in the figures may include a single pump such as for left ventricular assistance therapy, such as is illustrated in Figure 2, or for right ventricular assistance therapy only (not shown) or may include two pumps such as for left and right ventricular assistance therapy, such as is illustrated in Figures 1 , 3 and 4.
- Each embodiment of the invention described herein and illustrated in the figures may include only an external power source or battery 120, such as is illustrated in Figures 1 and 2, or an internal power source or battery 140, such as is illustrated in the embodiments of Figures 3 and 4, or both an internal and external power source or battery 120, 140.
- the heart assist device 100 includes two blood pumps 102, 104 for left and right ventricular assistance. In other embodiments, and as illustrated in Figures 2 to 5, the heart assist device 100 includes only one blood pump 102 for left (or right) ventricular assistance only.
- Each one of the blood pumps 102, 104 of the heart assist device 100 comprise a rotor or impeller suspended within a chamber of a pump housing.
- the pump 102, 104 receives blood into the chamber through an inlet and rotation of the rotor causes blood to be pumped out of an outlet.
- Rotation of the rotor is induced via a brushless motor arrangement which uses a direct current (DC) electric power supply and an electronic closed loop controller to switch DC currents to motor windings in a stator that produces magnetic fields which effectively rotate in space.
- Permanent magnets mounted in the rotor are influenced by the rotating magnetic fields which drives the rotation of the rotor.
- DC direct current
- other types of blood pumps requiring electrical power can be used.
- the one or more blood pumps 102, 104 are electrically connected to the implanted control module 130 via leads 131 , 132.
- the implanted control module 130 is in electrical connection with the transformer 10.
- the transformer 10 comprises an implanted core member 12, which is implanted, at least in part, internally within the patient 50 and an external core member 1 1 , which is located externally of the patient 50.
- Electrically conductive leads 133, 134 extend from the implanted control module 130 to the internal coil 40.
- the internal coil 40 is comprised of an electrically conductive material, such as a metallic wire, that is tightly wound around the implanted core member 12 one or more times. Accordingly, the internal coil 20 may include a single winding or n number of windings. Both ends 43, 44 of the internal coil 40 are electrically connected to the leads 133, 134 which are in turn connected to the implanted control module 130.
- the implanted core member 12 and the external core member 1 1 of the transformer 10 are each, preferably U-shaped, and are brought together to form a complete core 5 of the transformer, which is ring shaped or toroidal.
- the implanted core member 12 and the external core member 1 1 of the transformer 10 are made of mu-metal (nickel-iron alloys) and at least the implanted core member 12 is coated with a biocompatible material such as titanium.
- the implanted core member 12 is coated or overmoulded with a biocompatible material such as PEEK polymer material.
- the core transformer 10 is connected to a base member 32 that is in turn rigidly secured to bone.
- the transformer is connected to a base member 32 that is in turn rigidly secured to bone.
- the core transformer 10 and base member 32 are formed as a single, unitary component.
- the core transformer 10 and base member 32 are formed independently and are rigidly fixed together.
- the base member 32 is also made out of, or is coated with, biocompatible material such as titanium.
- the transformer 10 and base member 32 are joined by a mechanical join such as riveting, clamping or bolting, or through other means including brazing, soldering, or welding.
- the implanted core member 12 is coated or overmoulded with a biocompatible material such as PEEK polymer material which coats, overmoulds or forms the entirety of the base member 32.
- the implanted core member 12 of the transformer 10 comprises a pair of spaced apart parallel legs or shafts 14, 16 and a transverse web 18 extending between and connecting the shafts 14, 16.
- the external core member
- the resulting implanted core member 12 and external core member 1 1 each have a generally U-shaped or hemispherical shaped form.
- the shafts 13, 15, 14, 16 of the core members 1 1 , 12 are respectively spaced apart by the same distance.
- Shafts 13, 15 of the external core member 1 1 are, at least in part, hollow to allow for the insertion of the shafts 14, 16 of the internal core member 12. In use, the ends of the shafts 14, 16 are located supercutaneously (i.e. protruding from the outside of the skin).
- the ends of the shafts 13, 15 of the implanted core member 12 are configured for reversible attachment with respectively opposite ends of the shafts 14, 16 of the external core member 1 1 .
- threaded connection is envisaged for connection of the shafts 13, 15 of the external core member 1 1 to the shafts 14, 16 of the implanted core member 12 but other suitable means of secure attachment can be employed.
- the ends of the shafts 13, 15, 14, 16 of the core members 11 , 12 are thereby reversibly and securely coupled together to form an enclosed and completed ring shaped or toroidal core 5 of the transformer 10.
- the external coil 20 is secured to the ring shaped or toroidal core 5 of the transformer 10.
- the particular the external coil 20 is secured to the external core member 1 1 .
- the external coil 20 preferably winds around the external core member 11 once, or in other embodiments may wind around the external core member 1 1 more than once. Accordingly, the external coil 20 may include a single winding or n number of windings.
- the external coil 20 is configured to include a fastener, such as a latch 22, enabling the external coil 20 to be detachable.
- the external coil 20 is electrically connected with the external power source 120 either directly, or indirectly. Both ends 23, 24 of the external coil 20 are electrically connected to leads 1 13, 1 14 which are in turn connected to the external control module 1 10.
- the external control module 1 10 is in electrical connection with the external power source 120 via a power lead 122.
- the external control module 1 10 also includes a charging cable 128, which includes a transformer, that is connectable to a mains power supply for recharging the external power source 120.
- the power transmission apparatus 1 which includes the core transformer 10, is rigidly secured to bone.
- the implanted core member 12 of the transformer 10 is rigidly secured to the base member 32 which is adapted to be removably attachable and rigidly fixed to the iliac crest 52 of the patient 50 via base portion 32.
- the base portion 32 is rigidly fixed to the iliac crest 52 via one or more bone screws 35.
- the implanted core member 12 of the transformer 10 is rigidly secured to the base member 32 which is adapted to be removably attachable and rigidly fixed to a rib 54 via one or more bone screws 35.
- the rigid connection between the base member 32 and the iliac crest 52 or rib 54 of the patient 50 prevents any movement of part of the implanted power transmission apparatus 1 that penetrates the skin of the patient 54, which in embodiments includes the parallel legs or shafts 14, 16 of the implanted core member 12. Therefore risks of inflammation and infection of surrounding tissue are minimised, as are other complications that may arise from movement of existing percutaneous leads.
- the base member 32 is moulded to confirm to the three-dimensional shape of the and the iliac crest 52 or rib 54 of the patient 50.
- the base member 32 can be formed out of a moulded or 3D printed biocompatible material such as a titanium alloy or PEEK polymer.
- Embodiments of the invention employing a toroidal core transformer are advantageous as they provide for the efficient transmission of high amounts of power with minimal heat generation, which is beneficial for powering implantable medical devices whilst preventing tissue damage.
- Components of the power and data transmission apparatus 1 are preferably made of biocompatible materials such as titanium and are preferably adapted for implantation into the body of patient 50 for prolonged periods.
- the invention in another aspect, and with reference to Figures 6 to 8, relates to a method for transmitting power and preferably also data, between external and internal components of a heart assist device.
- FIG. 6 illustrates a schematic representation of the power and data (signal) transmission apparatus 1 of Figures 1 to 5 and a method of operation thereof.
- the external power supply 120 supplies power to the external controller 1 10 through the power supply connector 122.
- the external controller 1 10 directly passes alternating current (AC) voltage from the external power supply 120 or converts direct current (DC) to alternating current (AC) which is provided via leads 1 13, 1 14 to the external coil 20.
- the alternating current provided to the external coil induces, through the core transformer 10, an alternating current voltage in the internal coil 22.
- Power from the internal coil 40 is passed by leads 133, 134 to the internal control module 130 which includes a rectifier 135 where converted to direct current (DC) and passed through one or more leads 131 , 132 to power the heart assist device 100.
- power and data is transmitted from the external control module 110 to the internal control module 130.
- the external control module 110 is adapted to provide data, such as programming data, to be sent to the internal control module 130 to control the operation of the one or more implanted pumps 102, 104. For example, to control the programmed speed and/or flow rates of the implanted pumps 102, 104 to achieve a desired therapeutic effect.
- the external control module 1 10 is adapted to control the amplitude of the wave-forms of the voltage of the electrical power supplied to the external coil 20 (i.e. amplitude modulation).
- the amplitude of the wave-forms of the voltage of the electrical power induced in the internal coil 40 is detected, such as by filtering, and is processed in a processor 138 in the internal control module 130.
- the data is encoded by the external control module 1 10 in the amplitude of the wave forms and is decoded by the internal control module 130. As illustrated in Figure 7, preferably the data is encoded in binary 1 -0 data at a frequency of about 1 MHz.
- the decoded data is used to reconfigure or to reprogram the operation of the internal control module 130.
- data is transmitted from the internal control module 130 to the external control module 1 10 using the amplitude modulation method described above.
- data is transmitted from the internal control module 130 to the external control module 1 10.
- Data is encoded in the internal control module 130 (preferably in binary 1 - 0 data at a frequency of about 1 MHz as illustrated in Figure 7) and the internal control module 130 is adapted to control a switch 139, which is preferably located within the internal control module 130, to temporarily short the circuit comprising the internal coil 40.
- the temporary short circuit applied to the internal coil 40 causes temporary variations in load impedance of the external coil 20 or “load spikes”. These load spikes, which are represented in the amplitude of wave forms of impedance of the external coil 20, are detected and decoded by a processor 148 on-board the external control module 1 10.
- Data transmitted from the internal control module 130 to the external control module 1 10 can include data representing the performance and operation of the internal control module 130 and/or the implanted pumps 102, 104, such as telemetry data, or other data useful to a clinician in determining an appropriate therapy for the patient 50.
- data is transmitted from the external control module 1 10 to the internal control module 130 using the load spiking method described above.
- data is transmitted between the external control module 1 10 and the internal control module 130 by frequency shift keying (FSK).
- FSK frequency shift keying
- the frequency of a carrier signal is modulated (i.e. frequency modulation) with discrete frequency changes to thereby transmit and receive digital information.
- the instantaneous frequency of the carrier is shifted among a set of frequencies, namely 2 frequencies or 4 frequencies.
- the frequencies may represent digits, such as 'O' and T.
- the carrier signal is transmitted between the internal coil 40 and the external coil 20 and the amplitude of the wave-forms of the voltage of the electrical power induced in the internal coil 40 or the external coil 20 is detected, such as by filtering, and is processed in a processor 138, 148 in the internal or external control module 130, 1 10.
- the decoded data is used to reconfigure or to reprogram the operation of the internal control module 130 or to represent the performance and operation of the internal control module 130 and/or the implanted pumps 102, 104 (i.e. telemetry data) or other data useful to a clinician in determining an appropriate therapy for the patient 50.
- data is transmitted between the external control module 110 and the internal control module 130 by wireless communication.
- a coil antenna and/or transmitter is implanted in the patient and is connected to the internal control module 130.
- An antenna and/or transmitter is preferably also connected to the external control module 110.
- the antennae and transmitters are adapted for transmitting and receiving data encoded in radio waves.
- the processors 138, 148 of the internal and external control modules 1 10, 130 are configured to encode, decode, transmit and receive data with which to reconfigure, reprogram or monitor the operation of the heart assist device 100.
- the data is transmitted according to the Medical Implant Communication System (MICS) standard which is a low-power, short- range (2 m), high-data-rate 401-406 MHz (the core band is 402-405 MHz) communication network that has been accepted worldwide for transmitting data to support the diagnostic or therapeutic functions associated with medical implant devices.
- the data is transmitted according to the Bluetooth standard which utilises ultra-high frequency (UHF) radio wave transmission to exchange data over short distances from 2.402 GHz to 2.48 GHz.
- UHF ultra-high frequency
Abstract
La présente invention concerne un appareil et un procédé de transmission d'énergie et de préférence de données à un dispositif d'assistance cardiaque implanté dans le corps d'un patient. L'appareil comprend un transformateur central, permettant une fixation rigide à un site osseux d'un patient, une bobine primaire du transformateur située à l'extérieur permettant une connexion électrique à des composants externes d'un dispositif d'assistance cardiaque, et une bobine secondaire du transformateur située à l'intérieur permettant une connexion électrique à des composants internes du dispositif d'assistance cardiaque. La bobine primaire est connectée à une alimentation électrique externe, pour l'induction d'une tension dans la bobine secondaire pour alimenter les composants internes du dispositif d'assistance cardiaque.
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AU2022901404A AU2022901404A0 (en) | 2022-05-24 | An apparatus and method for transmitting power and data across the skin to implantable medical devices | |
AU2022901404 | 2022-05-24 |
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WO2023225715A1 true WO2023225715A1 (fr) | 2023-11-30 |
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PCT/AU2023/050441 WO2023225715A1 (fr) | 2022-05-24 | 2023-05-24 | Appareil et procédé de transmission d'énergie et de données à travers la peau à des dispositifs médicaux implantables |
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Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5279292A (en) * | 1991-02-13 | 1994-01-18 | Implex Gmbh | Charging system for implantable hearing aids and tinnitus maskers |
US6092531A (en) * | 1998-02-10 | 2000-07-25 | Light Sciences Limited Partnership | Movable magnet transmitter for inducing electrical current in an implanted coil |
US20140378742A1 (en) * | 2011-07-11 | 2014-12-25 | Vascor, Inc | Transcutaneous power transmission and communication for implanted heart assist and other devices |
US20150290373A1 (en) * | 2014-04-15 | 2015-10-15 | Heartware, Inc. | Transcutaneous energy transfer systems |
US20190051988A1 (en) * | 2017-08-11 | 2019-02-14 | Oticon Medical A/S | Implantable medical device comprising a wireless transcutaneous link |
US10695476B2 (en) * | 2013-11-11 | 2020-06-30 | Tc1 Llc | Resonant power transfer systems with communications |
US20210170083A1 (en) * | 2019-12-04 | 2021-06-10 | Medtronic, Inc. | Implantable medical device including cable fastener |
WO2022077075A1 (fr) * | 2020-10-15 | 2022-04-21 | Cardiobionic Pty Ltd | Système et méthode d'assistance ventriculaire |
-
2023
- 2023-05-24 WO PCT/AU2023/050441 patent/WO2023225715A1/fr active Search and Examination
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5279292A (en) * | 1991-02-13 | 1994-01-18 | Implex Gmbh | Charging system for implantable hearing aids and tinnitus maskers |
US6092531A (en) * | 1998-02-10 | 2000-07-25 | Light Sciences Limited Partnership | Movable magnet transmitter for inducing electrical current in an implanted coil |
US20140378742A1 (en) * | 2011-07-11 | 2014-12-25 | Vascor, Inc | Transcutaneous power transmission and communication for implanted heart assist and other devices |
US10695476B2 (en) * | 2013-11-11 | 2020-06-30 | Tc1 Llc | Resonant power transfer systems with communications |
US20150290373A1 (en) * | 2014-04-15 | 2015-10-15 | Heartware, Inc. | Transcutaneous energy transfer systems |
US20190051988A1 (en) * | 2017-08-11 | 2019-02-14 | Oticon Medical A/S | Implantable medical device comprising a wireless transcutaneous link |
US20210170083A1 (en) * | 2019-12-04 | 2021-06-10 | Medtronic, Inc. | Implantable medical device including cable fastener |
WO2022077075A1 (fr) * | 2020-10-15 | 2022-04-21 | Cardiobionic Pty Ltd | Système et méthode d'assistance ventriculaire |
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