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.

Description

BACKGROUND OF THE INVENTION

I. Field of the Invention

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.

II. Discussion of the Prior Art

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.

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.

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.

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

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

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.

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;

FIG. 2 is an exploded view illustrating the parts comprising the electronics compartment;

FIG. 3 is an exploded view showing the battery compartment disconnected from the pulse generator compartment;

FIG. 4 is a perspective view similar to FIG. 2 but illustrating the male coupling/connector portion incorporated into the battery compartment; and

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

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.

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.

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.

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.

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.

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° 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.

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.

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.

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.

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.

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.

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.