U.S. patent application number 11/635283 was filed with the patent office on 2007-06-21 for implantable medical devices.
This patent application is currently assigned to Ventrassist Pty Ltd. Invention is credited to Peter Andrew Crosby, John Campbell Woodard.
Application Number | 20070142696 11/635283 |
Document ID | / |
Family ID | 38174626 |
Filed Date | 2007-06-21 |
United States Patent
Application |
20070142696 |
Kind Code |
A1 |
Crosby; Peter Andrew ; et
al. |
June 21, 2007 |
Implantable medical devices
Abstract
An active implantable medical device comprising a therapeutic
device, a controller and at least one rechargeable battery, wherein
a single hermetically sealed housing encapsulates a therapeutic
device, controller and rechargeable battery. A hermetically sealed
housing additionally encapsulates a wireless interface and a
commutator.
Inventors: |
Crosby; Peter Andrew;
(Manly, AU) ; Woodard; John Campbell; (Turramurra,
AU) |
Correspondence
Address: |
ALTERA LAW GROUP, LLC
6500 CITY WEST PARKWAY
SUITE 100
MINNEAPOLIS
MN
55344-7704
US
|
Assignee: |
Ventrassist Pty Ltd
|
Family ID: |
38174626 |
Appl. No.: |
11/635283 |
Filed: |
December 7, 2006 |
Current U.S.
Class: |
600/16 ; 607/34;
607/57 |
Current CPC
Class: |
A61M 60/00 20210101;
A61M 60/824 20210101; A61M 2205/3507 20130101; A61M 2205/8243
20130101; A61M 60/871 20210101; A61M 60/148 20210101; A61M 60/50
20210101; A61M 60/205 20210101 |
Class at
Publication: |
600/016 ;
607/057; 607/034 |
International
Class: |
A61M 1/12 20060101
A61M001/12 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 8, 2005 |
AU |
2005906904 |
Claims
1. 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.
2. The active implantable medical device as claimed in claim 1,
wherein said hermetically sealed housing additionally encapsulates
a wireless interface.
3. The active implantable medical device as claimed in claim 1,
wherein said hermetically sealed housing additionally encapsulates
a commutator.
4. The active implantable medical device as claimed in claim 1,
wherein said therapeutic device is a rotary blood pump.
5. The active implantable medical device as claimed in claim 1,
wherein a percutaneous lead is connected thereto.
6. The active implantable medical device as claimed in claim 1,
wherein a TETS is connected thereto.
7. 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.
8. An active implantable medical device as claimed in claim 7,
wherein a second hermetically sealed housing encapsulates said
therapeutic device.
9. 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.
10. 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.
Description
FIELD OF THE INVENTION
[0001] 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).
BACKGROUND OF THE INVENTION
[0002] 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.TM. 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.
[0003] 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.
[0004] 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.
[0005] The present invention aims to or at least address or
ameliorate one or more of the disadvantages associated with the
above mentioned prior art.
BRIEF DESCRIPTION OF THE INVENTION
[0006] 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.
[0007] Preferably, said hermetically sealed housing additionally
encapsulates a wireless interface.
[0008] Preferably, said hermetically sealed housing additionally
encapsulates a commutator.
[0009] Preferably, said therapeutic device is a rotary blood
pump.
[0010] Preferably, a percutaneous lead is connected thereto.
[0011] Preferably, a TETS is connected thereto.
[0012] 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.
[0013] Preferably, a second hermetically sealed housing
encapsulates said therapeutic device.
[0014] 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.
[0015] 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.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] Embodiments of the present invention will now be described
with reference to the accompanying drawings wherein:
[0017] FIG. 1 depicts a front cross-sectional view of a first
embodiment of the preferred invention;
[0018] FIG. 2 depicts a schematic view of a second embodiment of
the preferred invention;
[0019] FIG. 3 depicts a schematic view of a third embodiment of the
preferred invention; and
[0020] FIG. 4 depicts a schematic view of a fourth embodiment of
the preferred invention.
BRIEF DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0021] In a first preferred embodiment of the present invention, as
depicted in FIG. 1, an active implantable medical device 16 is
shown. In this embodiment, 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. Preferably, 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.
[0022] Preferably, 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.
[0023] 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.
[0024] In this first preferred embodiment, 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.
[0025] 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.
[0026] 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. This significantly reduces the surface area
required by the entire active implantable medical device 16 by
concentrating the volume of the active implantable medical device
16 in one area. Additionally, 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.
[0027] In the first preferred embodiment of the present invention,
the hermetically sealed housing 1 is moulded around the internal
components of the active implantable medical device 16. However,
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.
[0028] Preferably, 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. Preferably, the rechargeable battery 3 is
charged when the percutaneous lead 2 is connected to an external
power source.
[0029] 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.
[0030] 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 implantable medical device 16 is a Lithium Ion rechargeable
battery supplying a 12V power supply.
[0031] A second preferred embodiment, similar to first preferred
embodiment, is depicted in FIG. 2. In the second preferred
embodiment, the rotary blood pump 5 is driven by a commutator 4
which receives a drive signal from the pump controller 12.
[0032] 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 implantable medical device 16.
[0033] Additionally in the second preferred embodiment, 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.
[0034] 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. Preferably, 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. Additionally, 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. Preferably, 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.
[0035] 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.
[0036] Preferably, the wireless interface 15 is able to transmit
and receive data and instructions without the use of the
percutaneous lead 2. Thereby the pump controller 12 may be able to
wirelessly transmit and receive data and instructions to and from
the ECDM 14. Preferably, any wireless interface protocol may be
used including, but not limited to: Bluetooth.TM.; Zigbee.TM.;
Wi-Fi.TM.; 802.11a, b, & g.
[0037] 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.
[0038] 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 the skin 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 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.
[0039] In a third embodiment of the present invention is depicted
in FIG. 3, wherein 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.
[0040] 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.
[0041] 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.
* * * * *