Enhanced method and apparatus to identify and connect a small diameter lead with a low profile lead connector

• US 20030018364A1
• Filed: 04/30/2002
• Published: 01/23/2003
• Est. Priority Date: 07/17/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Sommer, John L., Werder, Jonathan C., Bonde, Eric H., Belden, Elisabeth L., Haubrich, Gregory J., Hess, Douglas N., Goedeke, Steven D., Thompson, David L., Blaha, Eric V., Cobian, Ryan, Nerison, Nels D.
• Granted Patent: US 6,968,235 B2
• Time in Patent Office: Days
• US Class Current: 607/37
• CPC Class Codes: A61B 2560/0219 of externally powered implanted units
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61N 1/025 Digital circuitry features of electrotherapy devices, e.g. memory, clocks, processors
• CPC Class Codes: A61N 1/37223 Circuits for electromagnetic coupling
• CPC Class Codes: A61N 1/37252 Details of algorithms or data aspects of communication system, e.g. handshaking, transmitting specific data or segmenting data
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: A61N 2001/0585 Coronary sinus electrodes

Abstract

The present invention provides a practical, multi-polar, in-line connector system for use in connecting implantable medical devices (IMD) and associated non-standard, low profile medical electrical leads. In addition, the present invention provides a system that uses tool less, frictional, sealed, compressive electrical connections for most or all of the electrical interconnections between an IMD and a low profile lead. A protective sleeve seals the lead connector to the non-standard port to prevent intrusion of body fluids therein. In addition, optional microchip-based circuitry coupled to the sleeve enables wireless communication and remote programming for diverse IMDs. Memory associated with the circuitry can store, update and reprogram a wide variety of information relevant to the IMD, the patient, and the attending physician, among others. For example, the microchip may be used to identify the lead type and characteristics, as well as other useful data.

Claims

1. An improved coupling for an implantable medical device, comprising:

a header module having at least one non-standard port;

a low profile connector having an outer diameter approximately equal to the inner diameter of the port and adapted to frictionally seat within said non-standard port; and

a protective sleeve member adapted to couple the low profile connector to the non-standard port;

wherein the non-standard port has an axial passageway coupling opposing sides of the header module and said axial passageway comprises a low profile connector-receiving portion aligned with a pull-tool receiving portion and wherein the low profile connector-receiving portion has a smaller inner diameter than a standard IS-1 port or a standard DF-1 port.

2. The improved coupling of claim 1, further comprising an operable microchip-based communication circuit coupled to the protective sleeve member and wherein the operable microchip-based communication circuit receives operational energy from a remote source of power and said remote source of power is at least a one of the following:

an ultrasonic power source, an optical power source, an electromagnetic power source, a power source of an implantable medical device, a power source coupled to a conductor of a medical electrical lead.

3. The improved coupling of claim 2, wherein the operable microchip circuit further comprises a read/write memory device and a communication circuit for wireless communication with remote equipment.

4. The improved coupling of claim 2, wherein the operable microchip circuit further comprises at least one of the group:

an application specific integrated circuit, an integrated circuit, a programmable logic device, an electrically erasable programmable read only memory, a radio frequency receiver, a radio frequency transponder, an interrupt-driven microprocessor, a static random access memory structure, a dynamic random access memory structure, a flexible circuit substrate.

5. The improved coupling of claim 1, wherein the protective sleeve is a deformable annular sleeve.

6. The improved coupling of claim 5, further comprising a longitudinal gap formed in the annular sleeve.

7. The improved coupling of claim 5, wherein the non-standard port has a first interlocking structure and the annular sleeve has a second interlocking structure which cooperates with the first interlocking structure to form a seal for the non-standard port, and wherein said seal is free of adhesive.

8. The improved coupling of claim 7, wherein said first interlocking structure comprises at least one of the following:

an annular ridge, an annular groove, a two sided annular structure defining an apex portion, a cylindrically-shaped strain relief bore opening to the external surface of the header module and having a diameter greater than the low profile connector-receiving portion or a conically-shaped strain relief bore opening to the surface of the header module.

9. The improved coupling of claim 1, further comprising a pull tool having a distal end adapted for insertion through the pull-tool receiving portion of the non-standard port and further adapted to engage a proximal end portion of the low profile connector.

10. The improved coupling of claim 9, wherein the pull tool further comprises an enlarged head portion and the length of said pull tool is greater than the length of the axial passageway.

11. The improved coupling of claim 10, further comprising a mechanical stop surface disposed between the connector-receiving portion and the pull-tool receiving portion.

12. The improved coupling of claim 1, further comprising a pull device at least partially disposed in the axial passageway.

14. The improved coupling of claim 13, wherein the annular protective sleeve further comprises a microchip-based radio frequency transponder having a memory storage unit and wherein the transponder is adapted to transmit and receive information from a remote radio frequency interrogation device.

15. The improved coupling of claim 14, wherein said memory storage unit stores at least one of the following codes:

a lead type code, a date code, a model code, a serial number code, a calibration code, an MRI compatibility code, a technical information code, a client code, a hospital code, a physician code, a patient code, a programming code, an amplifier gain code, a circuitry-update code, a service code or a version code.

16. The improved coupling of claim 13, wherein the perimeter of the enlarged opening has a rounded edge disposed at the junction of the enlarged opening and the exterior surface of the header module.

17. The improved coupling of claim 16, wherein the enlarged opening comprises a outer major opening and a inner minor opening and the at least one conductive pad is disposed in the inner minor opening and the outer major opening is adapted to sealingly receive an interlocking part of the protective sleeve which is coupled to the protective sleeve.

19. The improved coupling of claim 18, further comprising a microchip-based computerized processor coupled to the resilient annual sleeve.

13. An improved coupling for an implantable medical device, comprising:

a header module having either an IS-1 port or a DF-1 port and a nonstandard port formed therein and wherein said non-standard port has an enlarged opening, and a reduced diameter opening coupled to the enlarged opening, and wherein at least one electrically conductive pad is disposed on a surface of the enlarged opening;

a low profile connector having a proximal end adapted to fit snugly in a portion of the enlarged opening, wherein said low profile connector has at least one corresponding electrically conductive pad disposed near said proximal end;

an annular protective sleeve member wrapped around a portion of the end region of the low profile connector; and

an elongated pull tool having a distal end adapted to be inserted into the reduced diameter opening to thereby engage the proximal end of the low profile connector so that the low profile connector can be manually pulled to establish positive electrical communication between the at least one electrically conductive pad and the at least one corresponding electrically conductive pad.

18. A connector assembly for receiving a non-standard low profile medical lead, comprising:

a non-standard lead connector coupled to a low profile medical lead, wherein said non-standard lead connector has a maximum outer diameter less than the outer diameter of a standard IS-1 medical lead and a standard DF-1 medical lead;

a connector module having a non-standard port formed therein, said port having a mechanical stop at a predetermined depth and an axial bore formed through the mechanical stop and emerging on an opposite side of said connector module, wherein said nonstandard port has a cylindrical low profile lead engagement region of approximately the same inner diameter as the outer diameter of the non-standard lead connector;

at least one electrically conductive pad disposed in the low profile lead engagement region;

an elongated pull tool disposed at least partially in the axial bore and the non-standard port and wherein a distal end of the elongated pull tool is adapted to mechanically engage the non-standard lead connector; and

a resilient annular sleeve adapted to wrap around a portion of the low-profile lead connector and to establish contact with a portion of the non-standard port.

20. A method of connecting a non-standard lead to an implantable device, comprising the steps of:

aligning a pull tool with an open axial bore formed in medical lead connector block, wherein said axial bore is co-axial with and couples with a non-standard connector port and wherein said pull tool has a lead engaging structure disposed on its distal end;

inserting the distal end of said pull tool into the open bore until the distal end emerges from the non-standard port;

connecting the lead engaging structure of the pull tool to a proximal end of a low profile, non-standard medical lead;

wrapping a deformable, annular protective sleeve around the proximal end of the lead;

applying tension to the pull tool until the low profile non-standard lead is fully seated in the non-standard port; and

disengaging the distal end of the pull tool from the proximal end of the lead.