US20070142696A1 - Implantable medical devices - Google Patents
Implantable medical devices Download PDFInfo
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- US20070142696A1 US20070142696A1 US11/635,283 US63528306A US2007142696A1 US 20070142696 A1 US20070142696 A1 US 20070142696A1 US 63528306 A US63528306 A US 63528306A US 2007142696 A1 US2007142696 A1 US 2007142696A1
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- controller
- implantable medical
- medical device
- active implantable
- hermetically sealed
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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
- A61M60/80—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
-
- 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
- A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
- A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart 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
-
- 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
- A61M60/226—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly radial components
- A61M60/232—Centrifugal 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
- A61M60/40—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
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/515—Regulation using real-time patient data
-
- 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
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
-
- 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
- A61M60/50—Details relating to control
- A61M60/585—User interfaces
-
- 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
- A61M60/876—Implantable batteries
-
- 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
- A61M60/88—Percutaneous cables
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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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/35—Communication
- A61M2205/3507—Communication with implanted devices, e.g. external control
-
- 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
- A61M2205/82—Internal energy supply devices
- A61M2205/8237—Charging means
- A61M2205/8243—Charging means by induction
-
- 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
- A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
- A61M60/818—Bearings
- A61M60/824—Hydrodynamic or fluid film bearings
Definitions
- An active implantable medical device may generally include a power source (e.g. a battery), control means (e.g. an electronic circuit) and a means providing the therapeutic action (e.g. an electrode or mechanical pump).
- a power source e.g. a battery
- control means e.g. an electronic circuit
- a means providing the therapeutic action e.g. an electrode or mechanical pump.
- An active implantable medical device in which the means providing the therapeutic action is an electrode system can often be constructed in such a way that all the components with the exception of the means providing the therapeutic action are enclosed inside a single package, which is usually hermetically sealed.
- an electrode system e.g.: a pacemaker or implantable defibrillator
- the therapeutic action is mechanical in nature (such as the AbioCorTM fully implantable artificial heart by Abiomed, Danvers, Mass., USA), have in the past, been implanted in multiple components having separate hermetically sealed housings for each implanted component.
- the implanted components included a controller, at least one battery, and a therapeutic device.
- a therapeutic device means a medical device that: actively treats a medical condition of a patient, and requires a power source to operate.
- therapeutic devices include, but are not limited to: pacemakers, left ventricle assist devices, cochlear implants, implanted hearing aids, and neural simulators.
- each implanted component generally includes a separate hermetic sealed housing
- the implanted medical devices are often bulky and cumbersome.
- the increased surface area of multiple hermetical sealed housings may lead to increased risk of infection for patients implanted with such a device.
- multiple implanted components add to the manufacturing cost, and may compromise the system reliability.
- U.S. Pat. No. 6,269,266 Leysieffer and U.S. Pat. No. 6,736,770—Leysieffer et al describe similar implantable medical devices wherein a therapeutic device and at least one battery are packaged together in hermetically sealed housing and implanted within the body of a patient.
- the devices described within these disclosures are limited to including a therapeutic device with a battery and do not include a controller or device controller within the said hermetically sealed housing. Thereby the devices may require a separate implanted controller with additional housing or the controller may be required to be carried externally relative to the patient.
- the present invention aims to or at least address or ameliorate one or more of the disadvantages associated with the above mentioned prior art.
- the present invention consists of an active implantable medical device comprising a therapeutic device, a controller and at least one rechargeable battery, wherein a single hermetically sealed housing encapsulates said therapeutic device, said controller and said rechargeable battery.
- said hermetically sealed housing additionally encapsulates a wireless interface.
- said hermetically sealed housing additionally encapsulates a commutator.
- said therapeutic device is a rotary blood pump.
- a percutaneous lead is connected thereto.
- a TETS is connected thereto.
- the present invention consists of an active implantable medical device comprising a therapeutic device, a controller, an electrically conductive coil and at least one rechargeable battery, wherein a first hermetically sealed housing encapsulates said controller, said electrically conductive coil and said rechargeable battery.
- a second hermetically sealed housing encapsulates said therapeutic device.
- the present invention consists of an active implantable medical device comprising a therapeutic device, a controller, an electrically conductive coil and at least one rechargeable battery, wherein a first hermetically sealed housing encapsulates said electrically conductive coil and said rechargeable battery.
- the present inventions consists of a controller for a therapeutic device disposed within an active implantable medical device, said controller and said therapeutic device adapted to be powered by at least one rechargeable battery, wherein said controller and said therapeutic device and said rechargeable battery are all housed within a single hermetically sealed housing.
- FIG. 1 depicts a front cross-sectional view of a first embodiment of the preferred invention
- FIG. 2 depicts a schematic view of a second embodiment of the preferred invention
- FIG. 3 depicts a schematic view of a third embodiment of the preferred invention.
- FIG. 4 depicts a schematic view of a fourth embodiment of the preferred invention.
- an active implantable medical device 16 is shown.
- the active implantable medical device 16 includes rotary blood pump 5 comprising: a DC brushless motor comprising stator coils 7 mounted on opposed sides of an impeller 11 .
- the impeller 11 includes permanent encapsulated magnets (not shown) which interact and cooperate with the stator coils 7 , when sequentially energised.
- the stator coils are energised in a manner to facilitate the imparting of a magnetic torque force on the impeller 11 to encourage the impeller 11 to rotate within a cavity of a housing 1 .
- the impeller 11 preferably includes four blades 9 connected by struts 10 .
- the blades 9 preferably include a hydrodynamic bearing surface on the upper and lower surfaces of the blades 9 , which provide a means for hydrodynamic suspension when the impeller 11 is rotating at a sufficient speed.
- blood is urged from an inlet 17 to an outlet 8 by the centrifugal motion imparted by the rotating motion of the impeller 11 .
- the preferred blood path 6 through the blood pump 5 is shown diagrammatically in FIG. 1 .
- the active implantable medical device 16 has a hermetically sealed housing 1 that encapsulates: a therapeutic device, namely the mechanical components of the blood pump 5 (i.e. the impeller 11 , stators 7 , inlet 17 and outlet 8 ); a rechargeable battery 3 , and a controller 12 or pump controller. All of these implanted components are integrated and encapsulated into the one hermetically sealed housing 1 .
- the therapeutic device portions are mechanically operable.
- An example of a mechanical operable therapeutic device is the pumping motion of the impeller within the rotary blood pump 5 .
- the hermetically sealed housing 1 preferably encapsulates the therapeutic device portions, the rechargeable battery 3 , and the controller 12 .
- This encapsulation allows all of the implanted components of the blood pump 5 to be positioned and mounted within the single housing 1 .
- the implantation of the active implantable medical device 16 with a patient may be significantly easier and quicker for the clinician as there are fewer objects being implanted.
- a further advantage may be that having only a single housing 1 reduces the risk of infection, as the risk of infection is generally proportional to the surface area of the active implantable medical device 16 .
- the hermetically sealed housing 1 is moulded around the internal components of the active implantable medical device 16 .
- the housing 1 may alternatively encapsulate the implanted components by encasing the internal components in an alloy shroud, preferably titanium alloy, which is hermetically sealed by welding.
- the controller 12 receives instructions, data and power via a percutaneous lead 2 which exits the patient and electrically connects to an external power source (not shown in FIG. 1 ) or external controller (not shown in FIG. 1 ).
- the controller 12 also includes a commutator circuit and sequentially energises the stators 7 to produce the rotational torque drive force on the impeller 11 in accordance with a speed signal derived by the controller 12 .
- the controller 12 also is electrically connected to the rechargeable battery 3 .
- the controller 12 uses the rechargeable battery 3 as a means for storing an electrical charge so that if the percutaneous lead 2 is disconnected the pump may continue to operate.
- the rechargeable battery 3 is charged when the percutaneous lead 2 is connected to an external power source.
- the controller 12 may operate in a manner similar to the control method described in U.S. Pat. No. 6,866,625—Ayre et al. and the description of this disclosure is herein included within the present specification.
- the rechargeable battery 3 may include at least one rechargeable battery and this rechargeable battery may be of any type.
- the type of battery included within the active implantable medical device 16 is a Lithium Ion rechargeable battery supplying a 12V power supply.
- FIG. 2 A second preferred embodiment, similar to first preferred embodiment, is depicted in FIG. 2 .
- the rotary blood pump 5 is driven by a commutator 4 which receives a drive signal from the pump controller 12 .
- the pump controller 12 may be able to selectively switch between the two power sources depending on the circumstances and the power requirements of the active implantable medical device 16 .
- the commutator circuit 4 is shown as a separate component within the hermetically sealed housing 1 .
- the commutator circuit 4 in this embodiment is also maintained and controlled by the pump controller 12 .
- FIG. 2 also depicts diagrammatically the manner by which the percutaneous lead 2 exits the skin layer 17 of the patient and connects to an external power supply 13 .
- the active implantable medical device 16 is also electrically connected to the external controller and/or data manager 14 (herein referred to as ECDM 14 ).
- the ECDM 14 may serve as a backup controller in situations where the pump controller 12 fails.
- the ECDM 14 may manage and store relevant patient or active implantable medical device 16 data. The data may be received from the pump controller 12 through the percutaneous lead 2 .
- the ECDM 14 maybe a personal computer or laptop computer running software designed specifically for the purpose of an active implantable medical device control and/or an active implantable medical device data management.
- the pump controller 12 may also be electrically connected to a wireless interface 15 as depicted in FIG. 2 .
- the wireless interface 15 is also preferably encapsulated within the hermetically sealed housing 1 .
- the wireless interface 15 is able to transmit and receive data and instructions without the use of the percutaneous lead 2 .
- the pump controller 12 may be able to wirelessly transmit and receive data and instructions to and from the ECDM 14 .
- any wireless interface protocol may be used including, but not limited to: BluetoothTM; ZigbeeTM; Wi-FiTM; 802.11a, b, & g.
- the external power supply 13 maybe a mains power connection which is rectified to provide the required power for the active implantable medical device 16 and/or it may also be rechargeable or long life batteries.
- TETS transcutaneous energy transfer system
- TETS generally comprises a two electrical conductive coils positioned either side of the skin layer 17 of a patient.
- a first coil energises an electrical current is induced the second coil and whereby allowing the transmission of energy and data via the TETS.
- the main advantage of TETS is that the patient is not required to have a permanent exit wound from which the percutaneous lead 2 extends. Additionally, one of the said coils may be included within the housing 1 and would further minimise the amount of components to be implanted within a patient.
- a therapeutic device is hermetically sealed in a housing 1 with a controller 12 , commutator 4 and wireless interface 15 .
- the preferred therapeutic device for use with this second embodiment is a rotary blood pump 5 .
- a battery is housed within a second hermetically sealed housing 20 along with a first electrical conductive coil 21 of a TETS.
- the first coil 21 implanted beneath the skin layer 17 interacts with a second electrically coil 23 above the skin layer 17 .
- the first and second coils 21 & 23 interact by one coil inducing an electrical current in the opposed coil and thereby allowing the transmission and receipt of electrical energy and also coded data transmission across the transmission link 22 which formed between the first and second coils 21 and 23 .
- FIG. 4 In a fourth embodiment of the present invention is depicted in FIG. 4 , wherein a controller 12 and a battery 3 and a first coil 21 of the TETS are hermetically sealed within a second housing 20 .
- a therapeutic device is hermetically sealed within a first housing 1 .
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Abstract
Description
- The present invention relates to improvements to active implantable medical devices. An active implantable medical device may generally include a power source (e.g. a battery), control means (e.g. an electronic circuit) and a means providing the therapeutic action (e.g. an electrode or mechanical pump).
- An active implantable medical device in which the means providing the therapeutic action is an electrode system (e.g.: a pacemaker or implantable defibrillator) can often be constructed in such a way that all the components with the exception of the means providing the therapeutic action are enclosed inside a single package, which is usually hermetically sealed. However, more complicated active implantable medical devices, or those in which the therapeutic action is mechanical in nature (such as the AbioCor™ fully implantable artificial heart by Abiomed, Danvers, Mass., USA), have in the past, been implanted in multiple components having separate hermetically sealed housings for each implanted component. Typically, the implanted components included a controller, at least one battery, and a therapeutic device. For purposes of this specification, a therapeutic device means a medical device that: actively treats a medical condition of a patient, and requires a power source to operate. Examples of therapeutic devices include, but are not limited to: pacemakers, left ventricle assist devices, cochlear implants, implanted hearing aids, and neural simulators.
- As each implanted component generally includes a separate hermetic sealed housing, the implanted medical devices are often bulky and cumbersome. The increased surface area of multiple hermetical sealed housings may lead to increased risk of infection for patients implanted with such a device. Additionally, multiple implanted components add to the manufacturing cost, and may compromise the system reliability.
- U.S. Pat. No. 6,269,266—Leysieffer and U.S. Pat. No. 6,736,770—Leysieffer et al describe similar implantable medical devices wherein a therapeutic device and at least one battery are packaged together in hermetically sealed housing and implanted within the body of a patient. However, the devices described within these disclosures are limited to including a therapeutic device with a battery and do not include a controller or device controller within the said hermetically sealed housing. Thereby the devices may require a separate implanted controller with additional housing or the controller may be required to be carried externally relative to the patient.
- The present invention aims to or at least address or ameliorate one or more of the disadvantages associated with the above mentioned prior art.
- In accordance with a first aspect the present invention consists of an active implantable medical device comprising a therapeutic device, a controller and at least one rechargeable battery, wherein a single hermetically sealed housing encapsulates said therapeutic device, said controller and said rechargeable battery.
- Preferably, said hermetically sealed housing additionally encapsulates a wireless interface.
- Preferably, said hermetically sealed housing additionally encapsulates a commutator.
- Preferably, said therapeutic device is a rotary blood pump.
- Preferably, a percutaneous lead is connected thereto.
- Preferably, a TETS is connected thereto.
- In accordance with a second aspect the present invention consists of an active implantable medical device comprising a therapeutic device, a controller, an electrically conductive coil and at least one rechargeable battery, wherein a first hermetically sealed housing encapsulates said controller, said electrically conductive coil and said rechargeable battery.
- Preferably, a second hermetically sealed housing encapsulates said therapeutic device.
- In accordance with a third aspect the present invention consists of an active implantable medical device comprising a therapeutic device, a controller, an electrically conductive coil and at least one rechargeable battery, wherein a first hermetically sealed housing encapsulates said electrically conductive coil and said rechargeable battery.
- In accordance with a fourth aspect the present inventions consists of a controller for a therapeutic device disposed within an active implantable medical device, said controller and said therapeutic device adapted to be powered by at least one rechargeable battery, wherein said controller and said therapeutic device and said rechargeable battery are all housed within a single hermetically sealed housing.
- Embodiments of the present invention will now be described with reference to the accompanying drawings wherein:
-
FIG. 1 depicts a front cross-sectional view of a first embodiment of the preferred invention; -
FIG. 2 depicts a schematic view of a second embodiment of the preferred invention; -
FIG. 3 depicts a schematic view of a third embodiment of the preferred invention; and -
FIG. 4 depicts a schematic view of a fourth embodiment of the preferred invention. - In a first preferred embodiment of the present invention, as depicted in
FIG. 1 , an active implantablemedical device 16 is shown. In this embodiment, the active implantablemedical device 16 includesrotary blood pump 5 comprising: a DC brushless motor comprisingstator coils 7 mounted on opposed sides of animpeller 11. Theimpeller 11 includes permanent encapsulated magnets (not shown) which interact and cooperate with thestator coils 7, when sequentially energised. Preferably, the stator coils are energised in a manner to facilitate the imparting of a magnetic torque force on theimpeller 11 to encourage theimpeller 11 to rotate within a cavity of ahousing 1. Theimpeller 11 preferably includes fourblades 9 connected bystruts 10. Theblades 9 preferably include a hydrodynamic bearing surface on the upper and lower surfaces of theblades 9, which provide a means for hydrodynamic suspension when theimpeller 11 is rotating at a sufficient speed. - Preferably, blood is urged from an
inlet 17 to anoutlet 8 by the centrifugal motion imparted by the rotating motion of theimpeller 11. Thepreferred blood path 6 through theblood pump 5 is shown diagrammatically inFIG. 1 . - A similar blood pump to the
blood pump 5 of the first preferred embodiment is described in U.S. Pat. No. 6,227,797—Watterson et al and the description of that disclosure is herein included within this current embodiment. - In this first preferred embodiment, the active implantable
medical device 16 has a hermetically sealedhousing 1 that encapsulates: a therapeutic device, namely the mechanical components of the blood pump 5 (i.e. theimpeller 11,stators 7,inlet 17 and outlet 8); arechargeable battery 3, and acontroller 12 or pump controller. All of these implanted components are integrated and encapsulated into the one hermetically sealedhousing 1. - Preferably, the therapeutic device portions are mechanically operable. An example of a mechanical operable therapeutic device is the pumping motion of the impeller within the
rotary blood pump 5. - The hermetically sealed
housing 1 preferably encapsulates the therapeutic device portions, therechargeable battery 3, and thecontroller 12. This encapsulation allows all of the implanted components of theblood pump 5 to be positioned and mounted within thesingle housing 1. This significantly reduces the surface area required by the entire active implantablemedical device 16 by concentrating the volume of the active implantablemedical device 16 in one area. Additionally, the implantation of the active implantablemedical device 16 with a patient may be significantly easier and quicker for the clinician as there are fewer objects being implanted. A further advantage may be that having only asingle housing 1 reduces the risk of infection, as the risk of infection is generally proportional to the surface area of the active implantablemedical device 16. - In the first preferred embodiment of the present invention, the hermetically sealed
housing 1 is moulded around the internal components of the active implantablemedical device 16. However, thehousing 1 may alternatively encapsulate the implanted components by encasing the internal components in an alloy shroud, preferably titanium alloy, which is hermetically sealed by welding. - Preferably, the
controller 12 receives instructions, data and power via apercutaneous lead 2 which exits the patient and electrically connects to an external power source (not shown inFIG. 1 ) or external controller (not shown inFIG. 1 ). Thecontroller 12 also includes a commutator circuit and sequentially energises thestators 7 to produce the rotational torque drive force on theimpeller 11 in accordance with a speed signal derived by thecontroller 12. Thecontroller 12 also is electrically connected to therechargeable battery 3. Thecontroller 12 uses therechargeable battery 3 as a means for storing an electrical charge so that if thepercutaneous lead 2 is disconnected the pump may continue to operate. Preferably, therechargeable battery 3 is charged when thepercutaneous lead 2 is connected to an external power source. - Preferably, the
controller 12 may operate in a manner similar to the control method described in U.S. Pat. No. 6,866,625—Ayre et al. and the description of this disclosure is herein included within the present specification. - Preferably, the
rechargeable battery 3 may include at least one rechargeable battery and this rechargeable battery may be of any type. Preferably, the type of battery included within the active implantablemedical device 16 is a Lithium Ion rechargeable battery supplying a 12V power supply. - A second preferred embodiment, similar to first preferred embodiment, is depicted in
FIG. 2 . In the second preferred embodiment, therotary blood pump 5 is driven by acommutator 4 which receives a drive signal from thepump controller 12. - Preferably in the second embodiment, the
pump controller 12 may be able to selectively switch between the two power sources depending on the circumstances and the power requirements of the active implantablemedical device 16. - Additionally in the second preferred embodiment, the
commutator circuit 4 is shown as a separate component within the hermetically sealedhousing 1. Thecommutator circuit 4 in this embodiment is also maintained and controlled by thepump controller 12. -
FIG. 2 also depicts diagrammatically the manner by which thepercutaneous lead 2 exits theskin layer 17 of the patient and connects to anexternal power supply 13. Preferably, the active implantablemedical device 16 is also electrically connected to the external controller and/or data manager 14 (herein referred to as ECDM 14). TheECDM 14 may serve as a backup controller in situations where thepump controller 12 fails. Additionally, theECDM 14 may manage and store relevant patient or active implantablemedical device 16 data. The data may be received from thepump controller 12 through thepercutaneous lead 2. Preferably, theECDM 14 maybe a personal computer or laptop computer running software designed specifically for the purpose of an active implantable medical device control and/or an active implantable medical device data management. - The
pump controller 12 may also be electrically connected to awireless interface 15 as depicted inFIG. 2 . Thewireless interface 15 is also preferably encapsulated within the hermetically sealedhousing 1. - Preferably, the
wireless interface 15 is able to transmit and receive data and instructions without the use of thepercutaneous lead 2. Thereby thepump controller 12 may be able to wirelessly transmit and receive data and instructions to and from theECDM 14. Preferably, any wireless interface protocol may be used including, but not limited to: Bluetooth™; Zigbee™; Wi-Fi™; 802.11a, b, & g. - The
external power supply 13 maybe a mains power connection which is rectified to provide the required power for the active implantablemedical device 16 and/or it may also be rechargeable or long life batteries. - Alternatively, the
percutaneous lead 2 may be replaced with the transcutaneous energy transfer system (herein referred to as ‘TETS’). TETS generally comprises a two electrical conductive coils positioned either side of theskin layer 17 of a patient. When a first coil energises an electrical current is induced the second coil and whereby allowing the transmission of energy and data via the TETS. The main advantage of TETS is that the patient is not required to have a permanent exit wound from which thepercutaneous lead 2 extends. Additionally, one of the said coils may be included within thehousing 1 and would further minimise the amount of components to be implanted within a patient. - In a third embodiment of the present invention is depicted in
FIG. 3 , wherein a therapeutic device is hermetically sealed in ahousing 1 with acontroller 12,commutator 4 andwireless interface 15. The preferred therapeutic device for use with this second embodiment is arotary blood pump 5. A battery is housed within a second hermetically sealedhousing 20 along with a first electricalconductive coil 21 of a TETS. Thefirst coil 21 implanted beneath theskin layer 17 interacts with a secondelectrically coil 23 above theskin layer 17. The first andsecond coils 21 & 23 interact by one coil inducing an electrical current in the opposed coil and thereby allowing the transmission and receipt of electrical energy and also coded data transmission across thetransmission link 22 which formed between the first andsecond coils - In a fourth embodiment of the present invention is depicted in
FIG. 4 , wherein acontroller 12 and abattery 3 and afirst coil 21 of the TETS are hermetically sealed within asecond housing 20. A therapeutic device is hermetically sealed within afirst housing 1. - The above descriptions detail only some of the embodiments of the present invention. Modifications may be obvious to those skilled in the art and may be made without departing from the scope and spirit of the present invention.
Claims (10)
Priority Applications (3)
Application Number | Priority Date | Filing Date | Title |
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US14/010,349 US8858416B2 (en) | 2005-12-08 | 2013-08-26 | Implantable medical devices |
US14/452,455 US20150031938A1 (en) | 2005-12-08 | 2014-08-05 | Implantable medical devices |
US15/969,660 US10471193B2 (en) | 2005-12-08 | 2018-05-02 | Implantable medical devices |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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AU2005906904 | 2005-12-08 | ||
AU2005906904A AU2005906904A0 (en) | 2005-12-08 | Improvements to Implantable Medical Devices |
Related Child Applications (1)
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US14/010,349 Division US8858416B2 (en) | 2005-12-08 | 2013-08-26 | Implantable medical devices |
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US20070142696A1 true US20070142696A1 (en) | 2007-06-21 |
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US14/452,455 Abandoned US20150031938A1 (en) | 2005-12-08 | 2014-08-05 | Implantable medical devices |
US15/969,660 Expired - Fee Related US10471193B2 (en) | 2005-12-08 | 2018-05-02 | Implantable medical devices |
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Application Number | Title | Priority Date | Filing Date |
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US14/010,349 Expired - Fee Related US8858416B2 (en) | 2005-12-08 | 2013-08-26 | Implantable medical devices |
US14/452,455 Abandoned US20150031938A1 (en) | 2005-12-08 | 2014-08-05 | Implantable medical devices |
US15/969,660 Expired - Fee Related US10471193B2 (en) | 2005-12-08 | 2018-05-02 | Implantable medical devices |
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Also Published As
Publication number | Publication date |
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US10471193B2 (en) | 2019-11-12 |
US8858416B2 (en) | 2014-10-14 |
US20150031938A1 (en) | 2015-01-29 |
US20140005466A1 (en) | 2014-01-02 |
US20180318485A1 (en) | 2018-11-08 |
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