Implantable medical device

An implantable medical device including a first generator. The first generator includes a first power source coupled to a first controller. The first header is removably coupled to the first generator and includes a first lead configuration. The device includes a first lead with a lead body having first terminals and at least one electrode on an end opposite the first terminals. The first terminals are removably received and secured by the first lead configuration of the first header and configured to communicate with the first generator.

BACKGROUND

The present invention relates to an implantable medical device.

Stimulators provide therapy for a variety of treatments. A stimulator includes a control module (with a pulse generator), one or more leads, and an array of stimulator electrodes on each lead. The stimulator electrodes are in contact with or near the nerves, muscles, or other tissue to be stimulated. The pulse generator in the control module generates electrical pulses that are delivered by the electrodes to body tissue.

SUMMARY

In one embodiment, the invention provides an implantable medical device including a first generator. The first generator includes a first power source coupled to a first controller. The first header is removably coupled to the first generator and includes a first lead configuration. The device includes a first lead with a lead body having first terminals and at least one electrode on an end opposite the first terminals. The first terminals are removably received and secured by the first lead configuration of the first header and configured to communicate with the first generator.

In another embodiment the invention provides an implantable medical device kit including a first generator and a second generator. The first generator includes a first power source and a first controller and the second generator includes a second power source and a second controller. A header is configured to be removably coupled to each of the first generator and the second generator. A lead includes a lead body having terminals on a first end and at least one electrode on a second end opposite the first end. The terminals are removably secured to the header and configured to communicate with each of the first generator and second generator.

In another embodiment the invention provides an implantable medical device kit including a generator with a power source and a controller. The device kit further includes a first header and a second header. The first header includes a first lead configuration for removably receiving and securing first terminals of a first lead. The first lead includes at least one electrode on an end opposite the first terminals and is configured to communicate with the generator. The second header includes a second lead configuration for removably receiving and securing second terminals of a second lead. The second lead includes at least one electrode on an end opposite the second terminals and is configured to communicate with the generator. Each of the first header or the second header is configured to be removably coupled to the generator.

DETAILED DESCRIPTION

FIGS. 1-9illustrate an electrical stimulation device10. The electrical stimulation device includes a header14, a core unit or controller18, and a power source22(e.g., a battery unit). In the embodiment illustrated inFIG. 1A, the header14is removably coupled to and communicates with the controller18. Similarly, the power source22is removably coupled to and communicates with the controller18. When mechanically and communicatively coupled, the controller18and the power source22define a generator26. As such, the header14, the controller18, and the power source22are distinct structures that are removable from one another. Additionally, each of the header14, the controller18, and the power source22are interchangeable with replacement or alternative headers14, controllers18, and power source22.

The header14includes a header housing30configured to removably secure at least one lead34. Each lead34includes a lead body38including a first end having terminals42and a second end, which is opposite the first end, having an electrode46. The header housing30defines at least one aperture50into which the first end is be inserted, as shown by directional arrow54. The header housing30also includes a plurality of contacts (not shown) disposed within the aperture50. When the lead34is inserted into the aperture50, the contacts can be aligned with the terminals42on the lead34such that the controller18, which communicates with the header14, is in communication with the electrode46disposed at a second end of the lead34. In the embodiment ofFIG. 1, the header14of device10includes two apertures50such that two leads34may be removable secured to the header14. In the embodiment ofFIG. 2, the header14″ includes four apertures50′ such that four leads34may be removably secured to the header14. While the headers14,14″ are illustrated to accommodate two leads34and four leads34, it should be understood that the headers14,14″ may be configured to accommodate any number of leads34.

The power source22is a battery pack including a housing58. The power source22may include recharge circuitry62that is configured to recharge the battery. Additionally or alternatively, the power source22may include power management circuitry66that is configured to manage the power output of the battery pack. The power source22may also be configured via measurement circuitry70(i.e., sensors and the like) to measure voltages, currents or temperatures associated with the battery, or rates of change of these parameters, and control recharging and discharging according to the measured values.

The controller18includes a housing74and is configured, when coupled to and powered by the power source22, to deliver pulses of energy to the patient P via communication with the header14and the leads34.FIG. 3illustrates several capabilities of the controller18, although the controllers illustrated herein are merely exemplary and therefore may include alternative functionalities. In the illustrated embodiment, the controller18includes circuitry78configured to store (i.e., in a read-only memory (ROM), random access memory (RAM), electronically-erasable programmable ROM (EEPROM), flash memory, etc.) instructions for controlling the stimulation device. Data collected while the device10is in use may also be stored for further analysis. The controller18may also include a processor82such as a microprocessor. For example, the microprocessor may be one of a digital signal processor, an application specific integrated circuit, a field-programmable gate array, or other logic circuitry. The controller18also includes telemetry circuitry86, which enables processor82to communicate with other devices (i.e., the header14and the power source22or external programming device via radio-frequency communication). The stimulation device delivers10electrical stimulation, and more particularly, the controller18includes therapy delivery circuitry90within housing74that generates electrical stimulation. For example, the therapy delivery circuitry90comprises circuits for the generation of electrical stimulation in the form of pulses, such as capacitors and switches. The controller18may also include sensors94that inform the device10of conditions of the patient P (i.e., position sensors, heart rate sensors, blood pressure sensors, temperature sensors, pH sensors, etc.).

As discussed above, the stimulation device10is configured such that the controller18communicates with the both the header14and the power source22to supply electrical stimulation through the leads34to the patient P. However, the header14, the controller18, the power source22and the leads34are each distinct features that are removable and replaceable from one another while implanted in the body of the patient P.

For example,FIG. 5illustrates three different headers14,14′,14″ each having a different configuration. In the illustrated headers ofFIG. 5, the headers14,14′,14″ differ in the number of leads34that are connectable thereto. For example, the headers14and14″, as described above receive and removably secure two and four leads34, respectively. The header14′ includes three apertures for receiving and removably securing three leads34. Each of the headers14,14′,14″ may have a different lead configuration to accommodate leads having various terminal configurations. The headers14,14′,14″ also differ in the size and relative shape. It should be understood that the headers14,14′,14″ provided herein are merely exemplary and therefore, other headers14,14′,14″ having other configurations are within the scope of the invention.

Similarly,FIG. 5illustrates three different controllers18,18′,18″ each having a different functionalities and capabilities. For example, controller18includes circuitry configured to deliver pulses based on the patient's position while controllers18′ is configured to deliver variable pulses at rates of approximately 1200 Hz and pulse width of approximately 1000 microseconds and controller18″ is capable of being programmed by an external device (not shown). It should be understood that the controllers18,18′,18″ provided herein are merely exemplary and therefore, other controllers and alternative or additional functionality or other configurations are within the scope of the invention.

Further,FIG. 6illustrates three different power22,22′,22″ sources having different configurations. For example, power source22may have a voltage mode and an impedance mode while power source22′ is rechargeable and power source22″ is non-rechargeable. It should be understood that the power sources22,22′,22″ provided herein are merely exemplary and therefore, other power sources22,22′,22″ having alternative or additional functionality or other configurations are within the scope of the invention.

With continued reference toFIGS. 4-6, any of the headers14,14′,14″ ofFIG. 4may be coupled or communicate with any of the controllers18,18′,18″ ofFIG. 5. Similarly, the power source22,22′,22″ ofFIG. 6may be coupled or communicate with any of the controllers18,18′,18″ ofFIG. 6. Therefore,FIGS. 4-6illustrate a modular stimulation system100, which be part of a complete kit, in which an implantable device10may include a header14having any suitable configuration, a controller18having any configuration, and a power source22having any configuration.

FIGS. 7-9illustrate various implantable devices embodying the principles discussed above.

For example,FIGS. 7A, 8A, 9Aillustrate an implantable device10that is similar to that found inFIG. 1. The device10includes the first controller18and the first power source22that together make up a first generator26. The first header14is removably coupled to the first generator26and includes the first lead configuration104(i.e., accommodates two leads). As such the terminals42of the lead34(FIGS. 1 and 2) are removably received and secured by the first lead configuration104of the first header14and configured to communicate with the first generator26.

FIGS. 7A-7Cillustrate that the first generator26including the first controller18and the first power source22are capable of being decoupled from the first header14. As such, second and third headers14′,14″ may be coupled to the first generator such that any of the headers14,14′,14″ may be communicatively coupled to the first controller18of the first generator26.

FIGS. 8-9illustrate that the first generator26is removable from the first header14and replaceable with the second or the third generator26′ having a different configuration. In other words, both the first controller18and the first power source22can be removed and replaced (FIG. 9D) such that any type of generator may be constructed. Alternatively, as illustrated inFIGS. 8A-8C) the first power source22is removable from the first controller18and replaceable with second or third power sources22′,22″, which have other configurations. Further, as illustrated inFIGS. 9A-9C) the first controller18is removable from the first header14and the first power source22and replaceable with second or third controllers18′,18″, which have other configurations and capabilities. In any of the above-described embodiments, the terminals42of the lead34communicate with the any of the first, the second, and the third generators26,26′,26″. The generator26may have any configuration. Therefore, the generator26may be constructed from a combination of any one of the first, the second, or the third controllers18,18′,18″ with any one of the first, the second, or the third power sources22,22′,22″. Further, the terminals42communicate with any of the controllers18,18′,18″ and/or any of the power sources22,22′,22″ that make up the first, the second and the third generators26,26′,26″ or any other combination of controller and power source that make up the generator. Moreover, each of generators26,26′,26″, the controllers18,18′,18″, and the power sources22,22′,22″ illustrated herein are interchangeable after implantation and without the entire device10being removed. The lead34is also removable from the header14and replaceable with a other leads34without removing entire device10.

It should be understood that each lead34is removably coupled with the headers14,14′,14″ by one of a direct electrical coupling, a conductive coupling, an inductive coupling, an electromagnetic induction coupling, an electrodynamic induction coupling or a resonant inductive coupling. Additionally, each of the headers14,14′,14″ is removably coupled to the generators26,26′,26″, and in particular the controllers18,18′,18″, by one of a magnetic coupling, an optical coupling, a mechanical coupling, or an electrical coupling.

It should be understood that the headers14,14′,14″, the controllers18,18′,18″, and the power sources22,22′,22″ are mechanically coupled to one another such that they remain in close proximity to one another while implanted in the patient P.FIG. 10illustrates a device having an exemplary mechanical connection between the header14, the controller18, and the power source22. In the embodiment illustrated inFIG. 10, the connector18includes a projection98that is sized and shaped to be received within a groove102of the header14. Similarly, the power source22includes a projection106that is sized and shaped to be received within a groove110in the connector18. The projections98,106are slidable relative to and within the grooves102,110, respectively. The mechanical connection illustrated inFIG. 10is merely exemplary and therefore, it should be understood that any type of mechanical connection is within the scope of the invention. Each of the header, the controller, and the power source may include snap fit interfaces or friction fit interfaces as alternative mechanical connections.

In practice and with reference toFIG. 6, a first device10including, for example, the first header14having the first lead configuration104, the first controller18, and the first power source22may be implanted into a patient P such that the leads34communicate between the device and the patient. As time progresses, technology advances, or the patient's needs change, it may be necessary to exchange the first header14with the second or third header14′,14″. Therefore, the first header14may be disconnected from the first generator26(i.e., the first controller18) and removed from the patient P. At this point, the second or third header14,14″ may be connected to the first generator26to communicate with the same. It should be understood that this process is applicable to the first controller18and the first power source22as well. That is that each of the first controller18and the first power26source may be disconnected from the device10and replaced with the second and the third controllers18′,18″ and power sources22′,22″, respectively. Similarly, the leads34may be removed and exchanged if necessary. Additionally, any combination of the header14, the controller18, the power source22and the leads34may be removed and replaced depending the needs of the patient and the available technology.

The modular system100described herein is advantageous because components (i.e., the headers, the controllers, the power sources, and the leads) of implantable devices10may be interchangeable for other of the same components. Therefore, components that are perfectly usable may be continued to be used for the lifespan of the component and only components that are need to be replaced need be removed and exchanged.

The electrical stimulation device10, leads34, and electrodes46are generally implanted subcutaneously. The placement of the electrical stimulation device10and the electrodes46may be positioned subcutaneously in any suitable location. Further, as discussed in detail above, the leads34are routed from the device10to the electrodes46to stimulate the surrounding tissue. For example, if the device10is used as a neurostimulator, the electrodes46are placed on adjacent to neural elements or structures (i.e., the brain, spinal cord, neural roots etc.) while the device10is positioned in the chest wall or the abdominal wall, for example.