U.S. patent application number 11/971137 was filed with the patent office on 2008-05-08 for implantable medical device with detachable battery compartment.
This patent application is currently assigned to Cardiac Pacemakers, Inc.. Invention is credited to Leonard J. Gramse, Robert J. Hanowski.
Application Number | 20080109044 11/971137 |
Document ID | / |
Family ID | 34193855 |
Filed Date | 2008-05-08 |
United States Patent
Application |
20080109044 |
Kind Code |
A1 |
Gramse; Leonard J. ; et
al. |
May 8, 2008 |
IMPLANTABLE MEDICAL DEVICE WITH DETACHABLE BATTERY COMPARTMENT
Abstract
An implantable medical electronic tissue stimulating device is
formed of two hermetically sealed, fluid impervious housings, one
containing an electronic pulse generator and the other a battery
power supply. The two are adapted to be mechanically and
electrically coupled together through a coupler/connector whereby
current from the battery in one sealed housing is fed to the
electronic pulse generator in the other sealed housing.
Inventors: |
Gramse; Leonard J.; (St.
Paul, MN) ; Hanowski; Robert J.; (St. Paul,
MN) |
Correspondence
Address: |
SCHWEGMAN, LUNDBERG & WOESSNER, P.A.
P.O. BOX 2938
MINNEAPOLIS
MN
55402
US
|
Assignee: |
Cardiac Pacemakers, Inc.
|
Family ID: |
34193855 |
Appl. No.: |
11/971137 |
Filed: |
January 8, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
10643369 |
Aug 19, 2003 |
7337002 |
|
|
11971137 |
Jan 8, 2008 |
|
|
|
Current U.S.
Class: |
607/36 |
Current CPC
Class: |
A61N 1/37512 20170801;
A61N 1/3758 20130101; A61N 1/375 20130101 |
Class at
Publication: |
607/036 |
International
Class: |
A61N 1/375 20060101
A61N001/375 |
Claims
1. An implantable medical device, comprising: a first hermetically
sealed housing containing electronic circuitry and including a
first threaded connector; and a second hermetically sealed housing
containing a battery and including a second threaded connector
configured to mate the first threaded connector, wherein the first
and second hermetically sealed housings are configured to be
connected to each other by mating the first and second threaded
connectors, including rotating the second hermetically sealed
housing relative to the first hermetically sealed housing, such
that the electronic circuitry is energized by the battery.
2. The implantable medical device of claim 1, wherein the
electronic circuitry comprises a pulse generator.
3. The implantable medical device of claim 1, wherein the first and
second hermetically sealed housings are removably connected to each
other.
4. The implantable medical device of claim 3, wherein the first
threaded connector is an internally threaded female connector, and
the second threaded connector is an externally threaded male
connector.
5. The implantable medical device of claim 4, wherein the first and
second hermetically sealed housings are aligned and locked together
by rotating the second hermetically sealed housing approximately 90
degrees.
6. The implantable medical device of claim 4, comprising a spring
biased latch projecting from the second hermetically sealed housing
and configured to prevent rotation of the second hermetically
sealed housing relative to the first hermetically sealed housing
after the first and second hermetically sealed housings are
connected.
7. The implantable medical device of claim 1, wherein the first
hermetically sealed housing and the second hermetically sealed
housing are each fabricated from a metal.
8. An implantable medical device, comprising: a first hermetically
sealed housing containing an electronic pulse generator and
including a threaded female connector; and a second hermetically
sealed housing containing a battery and including a threaded male
connector configured to mate the threaded female connector, wherein
the first and second hermetically sealed housings are configured to
be aligned and locked together by inserting the threaded male
connector into the threaded female connector and rotating the
second hermetically sealed housing relative to the first
hermetically sealed housing.
9. The implantable medical device of claim 8, wherein the first and
second hermetically sealed housings are removably connected by
inserting the threaded male connector into the threaded female
connector and rotating the second hermetically sealed housing
relative to the first hermetically sealed housing.
10. The implantable medical device of claim 9, wherein the first
and second hermetically sealed housing are aligned and locked
together by rotating the second hermetically sealed housing
approximately 90 degrees.
11. The implantable medical device of claim 9, comprising a
pacemaker.
12. The implantable medical device of claim 9, comprising a
defibrillator.
13. A method for making an implantable medical device, the method
comprising: providing a first hermetically sealed housing;
incorporating a first threaded connector into the first
hermetically sealed housing; providing a second hermetically sealed
housing; incorporating a second threaded connector into the second
hermetically sealed housing, the second threaded connector
configured to mate the first threaded connector such that the first
and second hermetically sealed housing are aligned and locked by
rotating the second hermetically sealed housing relative to the
first hermetically sealed housing; and placing electronic circuitry
in one of the first and second hermetically sealed housings.
14. The method of claim 13, wherein providing the first
hermetically sealed housing comprises providing two housing halves
each including a semicircular socket, and incorporating the first
threaded connector into the first hermetically sealed housing
comprises fitting the first threaded connector into the
semicircular sockets.
15. The method of claim 14, comprising: placing an electronic pulse
generator in the first hermetically sealed housing; and welding the
two housing halves together.
16. The method of claim 13, wherein incorporating the first
threaded connector into the first hermetically sealed housing
comprises incorporating a female connector into the first
hermetically sealed housing, and incorporating the second threaded
connector into the second hermetically sealed housing comprises
incorporating a male connector into the second hermetically sealed
housing.
17. The method of claim 13, wherein providing the first and second
hermetically sealed housings each comprise providing a metal
housing.
18. The method of claim 17, wherein placing the electronic
circuitry in one of the first and second hermetically sealed
housings comprises placing an electronic pulse generator in the
first hermetically sealed housing, and comprising placing a battery
in the second hermetically sealed housing to energize the
electronic pulse generator.
19. The method of claim 13, comprising: forming a groove on the
first hermetically sealed housing; and incorporating a spring
biased latch projecting from the second hermetically sealed
housing, the spring biased latch configured to fit into the
groove.
20. The method of claim 19, comprising: inserting the second
threaded connector into the first threaded connector; and rotating
the second hermetically sealed housing relative to the first
hermetically sealed housing.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. application Ser.
No. 10/643,369, filed Aug. 19, 2003, the specification of which is
herein incorporated by reference.
BACKGROUND OF THE INVENTION
[0002] I. Field of the Invention
[0003] This invention relates generally to implantable medical
tissue stimulating devices, and more particularly to a hermetically
sealed pulse generator with an independent, hermetically sealed
battery compartment.
[0004] II. Discussion of the Prior Art
[0005] Implantable pacemakers, cardiac defibrillators and neural
stimulators typically comprise a single hermetically sealed case or
housing containing a microprocessor and a pulse generator
controlled by the microprocessor for delivering tissue stimulating
pulses at programmed time intervals along with a battery power
supply for supplying electrical current to the electronic
circuitry. Given the complexity and capabilities of present-day
tissue stimulators, they may have a manufacturing cost approaching
ranging between $1,000.00 and $3,000.00.
[0006] The battery power supply may typically comprise a lithium
iodide cell in that such batteries do not generate a gas during
discharge that would make the sealing of the implantable device
problematic. Implantable medical devices of the type described
herein have a somewhat limited shelf life and a substantial cost
burden is incurred by the manufacturers of such devices in the
event that sales do not deplete the inventory quickly enough. In
that the battery and the somewhat expensive electronics are
necessarily contained within a hermetically sealed container or
housing, the entire device must be scrapped if the unit is not
implanted within a period of 12 months of manufacture for certain
modules and 24 months for others. Taking into account the number of
different models of pacemakers and AICDs manufacturers produce and
the need to maintain an inventory of each, losses due to scrapping
can easily reach several million dollars per year due to battery
depletion.
[0007] During the test and burn-in phase of manufacture, the
implantable device is subjected to elevated temperatures to stress
the integrated circuits and other components of the
microprocessor-controlled pulse generator to detect hardware
faults. The elevated temperatures are known to cause battery
degradation.
[0008] Thus, a need exists for an implantable tissue stimulator
that will have a fresh, fully charged battery at the time of
implant irrespective of the date of manufacture. The present
invention provides a solution.
SUMMARY OF THE INVENTION
[0009] The problems with the prior art design discussed above are
resolved in accordance with the present invention by providing an
implantable medical tissue stimulating device that comprises an
electronic pulse generator contained in a first hermetically sealed
housing member, a battery power supply contained in a second
hermetically sealed housing member and a means for mechanically and
electrically coupling the first and second housing members together
at the time of implant whereby a fresh battery begins to furnish
energy to the electronic circuitry at the time of implant rather
than at the time of manufacture of the pulse generator.
DESCRIPTION OF THE DRAWINGS
[0010] The foregoing features, objects and advantages of the
invention will become apparent to those skilled in the art from the
following detailed description of a preferred embodiment,
especially when considered in conjunction with the accompanying
drawings in which like numerals in the several views refer to
corresponding parts.
[0011] FIG. 1 is an isometric view of an implantable medical tissue
stimulator constructed in accordance with the present invention
where the battery compartment and the pulse generator compartment
are joined to one another;
[0012] FIG. 2 is an exploded view illustrating the parts comprising
the electronics compartment;
[0013] FIG. 3 is an exploded view showing the battery compartment
disconnected from the pulse generator compartment;
[0014] FIG. 4 is a perspective view similar to FIG. 2 but
illustrating the male coupling/connector portion incorporated into
the battery compartment; and
[0015] FIG. 5 is an enlarged cross-sectional view taken through the
coupling/connector and seal mechanically and electrically joining
the battery compartment to the pulse generator compartment.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0016] In FIG. 1 there is indicated generally by numeral 10 and
implantable medical tissue stimulating device, such as an
implantable pacemaker, an automatic implantable cardiac
defibrillator or other type of tissue stimulator known in the art.
It is seen to comprise a first hermetically sealed housing or
compartment 12 that is designed to contain the electronic circuitry
comprising a microprocessor-controlled pulse generator and a second
hermetically sealed housing 13 for containing an electrochemical
cell or battery for powering the electronic circuitry.
[0017] As is shown in the exploded view of FIG. 2, the housing 12
is preferably fabricated from a metal, such as titanium, and is
comprised of two halves 12a and 12b that are brought together and
joined by welding along their mating edges 14 and 16. Before
welding the two halves together, an electronic circuit module 18 is
placed in the housing, as is a lead connector block assembly that
comprises a metal shell 20 having lead receiving bores as at 22 and
24 and a pocket into which is fitted a connector block 26. The
connector block 26 is formed from an insulating material and
includes longitudinally extending bores that are adapted to receive
the proximal terminal connectors on medical leads (not shown) that
plug into the openings 22 and 24 of the shell 20. Fitted into the
connector block 26 is a plurality of conductive lead locking blocks
28, 29, 30 and 31 into which contact areas on the proximal terminal
end of the medical lead are intended to mate. The connector block
assembly includes a feedthrough member 32 that becomes welded to
the base of the shell 20 to provide rf isolation. First, however,
conductive pins 34 on the feedthrough member 32 are welded to the
contact blocks 28-31 and to predetermined nodes on the electronic
circuit module 18. Insulating pads, as at 35 fit between the
contact blocks and electrically isolate the contact blocks and
feedthrough pins from the shell 20.
[0018] Thus, when the housing halves 12a and 12b are brought
together and welded, the electronic circuitry, as well as the
connector for the proximal terminal of medical leads, are
hermetically sealed within the housing. Also, a battery
coupler/connector 36 is fitted into semicircular sockets 38 formed
in the two housing halves 12a and 12b and welded in place. The
positive and negative poles 40 of the coupler/connector 36 are
welded to appropriate tie points on the electronic circuit 18 prior
to placement of the surrounding housing 12.
[0019] Referring again to FIG. 1, the second hermetically sealed
housing member 13 contains a battery power supply that when
appropriately coupled to the housing member 12 provides the
necessary energization for the electronic circuit module 18.
[0020] As best seen in FIG. 2, the battery housing 13 includes a
male coupler/connector member 44 that is adapted to mate with the
female coupler 36 forming part of the first housing 12 for the
electronics circuitry.
[0021] Referring next to FIG. 3, when the battery coupler/connector
member 44 is inserted into the coupling member 36 of the
hermetically sealed electronic circuit housing member 12 and then
the battery housing 13 is rotated approximately 90.degree. so that
the battery housing and the circuit housing become aligned as in
FIG. 1, the two housing halves become positively locked together.
This is achieved by providing a helical thread 46 of a
predetermined pitch on the battery terminal 44 and that mates with
an internal thread formed in the female coupler 36.
[0022] Illustrated in FIG. 5 is a cross-sectional view taken
through the battery housing 13 showing the chemical cell 42 and
through the coupler/connector member 44 and the mating female
coupler socket 36 to show their internal construction. The socket
36 forms one conductor for mating with a first battery terminal 45
while the center post 43 mates with the second battery terminal 47.
An insulating tube 48 surrounds battery terminal 47 and
electrically isolates it from the terminal 46.
[0023] Built into the above-described mechanism for removably
coupling the first and second housing members to one another is an
elastomeric seal 49 preventing ingress of body fluids into the
interface between the male battery coupler/connector member 44 and
the female coupler socket 36.
[0024] To prevent rotation of the battery housing 13 relative to
the circuit housing 12 once the coupler members 36 and 44 are
joined, a spring biased latch 50 projects from a side surface 52 of
the battery housing 13 as shown in FIGS. 3 and 4. The latch 50 is
designed to fit into an associated groove (not shown) formed midway
across the width dimension of the projecting portion 54 of the
housing 12. If it becomes necessary to uncouple the battery from
the electronics portion of the implantable device, a suitable
needle probe 55 (FIG. 1) may be inserted into the groove at its
entrance point 56 whereby the barb of latch 50 can be depressed so
as to no longer reside in the groove, at which point the battery
housing 13 can be rotated to uncouple the threaded connection
between the two coupler/connector members 36 and 44.
[0025] Thus, it can be seen that a secure mechanical and electrical
connection can be established between the battery supply 42
contained within the housing member 13 and the electronic circuitry
contained within the housing member 12 such that the necessary
operating voltages become available to the electronic circuitry.
Since this connection can be made at the time of implant, it is
assured that the battery will be fresh and need not have been
subjected to the elevated temperatures used during the test and
burn-in phase of manufacture of the device.
[0026] This invention has been described herein in considerable
detail in order to comply with the patent statutes and to provide
those skilled in the art with the information needed to apply the
novel principles and to construct and use such specialized
components as are required. However, it is to be understood that
the invention can be carried out by specifically different
equipment and devices, and that various modifications, both as to
the equipment and operating procedures, can be accomplished without
departing from the scope of the invention itself.
* * * * *