Lead Implant System

• US 20090276004A1
• Filed: 04/30/2008
• Published: 11/05/2009
• Est. Priority Date: 04/30/2008
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Kronich, Christine G., Sommer, John L., Wenger, William K., DuPay, Joseph A., Eggen, Michael D., Montgomery, Gerald Jordan
• Granted Patent: US 8,214,045 B2
• Time in Patent Office: Days
• US Class Current: 607/36
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/37211 Means for communicating with stimulators
• CPC Class Codes: A61N 1/37241 providing test stimulations
• CPC Class Codes: A61N 2001/37294 Means for testing medical devices within the package prior to implantation

Abstract

A lead implant system includes a lead coupling device, which is configured to couple a lead during an implant procedure, in communication with a medical device and an implantable medical device, which is contained within a package that includes an electrical interface for electrical coupling with an electrical contact of the implantable medical device. The electrical interface facilitates coupling of the packaged medical device to an electrical contact of another medical device, which is located outside the package. If the electrical contact of the packaged device is mounted within a bore of the device, then the connector structure allows for passage of a sterilizing gas into the connector bore, and past the connector contact, within the bore.

Claims

1. A system comprising:

a lead coupling device having a first wireless communication module, wherein the lead coupling device is adapted to receive a medical lead;

an interface device having a second wireless communication module configured for remote communication with the first wireless module;

a hermetically sealed medical device package;

an implantable medical device including a connector bore and an electrical contact contained within the hermetically sealed medical device package;

an electrical interface configured for coupling the electrical contact of the implantable medical device with the interface device, wherein the interface device is located outside the package; and

an implantable medical device programmer, wherein the programmer is configured for communication with the implantable medical device.

2. The system of claim 1, wherein the electrical interface comprises:

a connector structure;

a first contact surface disposed on the connector structure for electrical coupling with the electrical contact of the second device, within the bore of the connector module of the second device;

a substrate;

a second contact surface mounted on the substrate for electrical coupling with the interface device; and

a conductive lead coupling the first contact surface to the second contact surface.

3. The system of claim 2, wherein the connector structure is adapted to allow for passage of a sterilizing gas into the bore of the connector module and past the electrical contact of the implantable medical device.

4. The system of claim 2, wherein the conductive lead of the electrical interface comprises a pin member extending distally from the first contact surface, a conductive trace extending over the substrate, and a connective interface coupling the pin member to the conductive trace.

5. The system of claim 2, wherein the electrical interface further comprises:

a third contact surface and a fourth contact surface, each of the third and fourth contact surfaces being mounted on a side wall of the package; and

a distal conductive lead coupling the third contact surface to the fourth contact surface and extending along the side wall of the package, wherein;

the third contact surface is contained within the package, being directly coupled to the second contact surface; and

the fourth contact surface is located outside the package to connect with the first medical device for electrical coupling of the first medical device to the second contact surface.

6. The system of claim 1, wherein the lead coupling device includes:

a housing having a proximal opening at a proximal end and a distal opening at a distal end;

a lead receiving channel disposed within the housing and extending from the proximal opening to the distal opening, wherein said channel is adapted to receive the medical lead;

a pulse generator disposed within the housing for providing electrical energy;

a processor coupled to the pulse generator;

at least two electrical contacts mounted within the channel and coupled to the pulse generator, wherein a portion of the contacts is adapted to contact the lead; and

a power source disposed within the housing and coupled to the pulse generator.

7. The system of claim 6, further comprising sensing circuitry coupled to the processor, wherein the sensing circuitry is configured to receive a physiological parameter sensed by the lead.

8. The system of claim 7, wherein the sensed physiological parameter is processed to give an indication of a medium surrounding an electrode on the lead tip.

9. The system of claim 7, wherein the wherein the sensed physiological parameter is impedance.

10. The system of claim 1, wherein the first wireless communication module includes at least one of a communication protocol comprising distance telemetry, Bluetooth, IEEE 802.11.

12. The system of claim 9, wherein the electrical interface comprises:

a connector structure;

a first contact surface disposed on the connector structure for electrical coupling with the electrical contact of the implantable medical device, within the bore of the connector module of the second device;

a substrate;

a second contact surface mounted on the substrate for electrical coupling with the interface device; and

a conductive lead coupling the first contact surface to the second contact surface.

13. The system of claim 10, wherein the connector structure is adapted to allow for passage of a sterilizing gas into the bore of the connector module and past the electrical contact of the second device.

14. The system of claim 9, wherein the lead coupling device includes:

a housing having a proximal opening at a proximal end and a distal opening at a distal end;

a lead receiving channel disposed within the housing and extending from the proximal opening to the distal opening, wherein said channel is adapted to receive the medical lead;

a pulse generator disposed within the housing for providing electrical energy;

at least two electrical contacts mounted within the channel and coupled to the pulse generator, wherein a portion of the contacts is adapted to contact the lead; and

a power source disposed within the housing and coupled to the pulse generator.

15. The system of claim 12, further comprising sensing circuitry coupled to the processor, wherein the sensing circuitry is configured to receive a physiological parameter sensed by the lead.

16. The system of claim 12, wherein the lead coupling device further includes a display.

18. The system of claim 15, wherein the lead coupling device further comprises sensing circuitry coupled to the processor, wherein the sensing circuitry is configured to receive a physiological parameter sensed by the lead.

19. The system of claim 15, wherein the proximal end and the distal end are rotatably coupled so that relative rotation is permitted between the proximal end and the distal end.

11. A system comprising:

a lead coupling device having a first wireless communication module, wherein the lead coupling device is adapted to receive a medical lead;

an interface device having a second wireless communication module configured for remote communication with the first wireless module;

a hermetically sealed medical device package;

an implantable medical device including a connector bore and an electrical contact contained within the hermetically sealed package; and

an electrical interface configured for coupling the electrical contact of the implantable medical device with the interface device, wherein the first medical device is located outside the package.

17. A system comprising:

an interface device having a first wireless communication module;

a lead coupling device including;

a housing having a proximal opening at a proximal end and a distal opening at a distal end;

a lead receiving channel disposed within the housing and extending from the proximal opening to the distal opening, wherein said channel is adapted to receive a medical lead;

a second wireless communication module disposed within the housing configured for communication with the medical device;

a pulse generator disposed within the housing for providing electrical energy;

a processor coupled to the pulse generator;

at least two electrical contacts mounted within the channel and coupled to the pulse generator, wherein a portion of the contacts is adapted to contact the lead; and

a power source disposed within the housing and coupled to the pulse generator; and

an implantable medical device programmer, wherein the programmer is configured for communication with an implantable medical device.

20. The system of claim 17, wherein the lead coupling device further includes a display.