Multiple electrode catheter

• US 5,562,722 A
• Filed: 03/14/1994
• Issued: 10/08/1996
• Est. Priority Date: 03/14/1994
• Status: Expired due to Term

• Current Assignee: Custom Medical Applications, Inc.
• Original Assignee: Medical Evaluation Devices & Instruments Corp.
• Inventors: Racz, Gabor, Henderson, Donald R.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US08/212,545
• Time in Patent Office: 939 Days
• Field of Search: 607/116-117, 607/122, 607/126
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes

Abstract

An electrical stimulation catheter system particularly suited for treating the epidural space of a patient, which includes a multiple electrode stimulation catheter, a stiffening element for the catheter and a device for securing an implanted catheter to the patent. A catheter according to the invention includes first and second flexible electrodes defined respectively by a portion of the catheter body and second flexible element. Preferably, leads for each electrode are secured to slideable rings around the proximal end of the catheter to prevent entanglement and confusion of the leads. A catheter securing device according to the invention includes a resilient member having a bore within which the catheter is secured. Holes for suturing or adhesive coating are provided to secure the device, which also may serve as an external electrode, to the patient.

Claims

1. A catheter system, comprising:

a helically wound multiple electrode stimulation catheter comprising,

a helically wound inner member having distal and proximal ends, wherein at least the distal end is an electrically conductive material and wherein said inner member defines an inner lumen of said catheter,

a first insulating layer covering less than all of said inner member, wherein the distal end of said inner member is exposed to define a first, flexible helically wound electrode, wherein said first electrode comprises a first proximal portion having closely wound helices, a second central portion having spread apart helices to define a passage for fluid communication with said lumen, and a third distal portion having closely wound helices,

a second flexible electrode disposed around said first insulating layer and spaced proximally a predetermined distance from said first electrode, and

a second insulating layer around said catheter beginning at the second electrode and extending to the proximal end of the inner member; and

at least one stiffening element having a predetermined length and adapted to be inserted into the inner lumen of said catheter.

2. The catheter system according to claim 1, wherein the length of said at least one stiffening element is sufficient to extend from the proximal end of the inner member beyond the spread apart central portion when fully inserted into the inner lumen of the catheter.

3. The catheter system according to claim 2, wherein:

said third distal portion has a length equal to at least the length of said first and second portions together; and

said at least one stiffening element has a distal tip and said element is configured and dimensioned to be variably positioned within said catheter with the distal tip variably located in said third portion.

4. The catheter system according to claim 1, wherein said catheter includes at least one viewing portion, spaced proximally from said first and second electrodes, wherein the helices of the inner member are spread apart, and said first and second insulating layers are sufficiently transparent to permit viewing of fluids within said catheter.

5. The catheter system according to claim 2, further including at least one securing member adapted to receive and secure said at least one catheter to a patient'"'"'s body, wherein said securing member comprises:

a base portion, wherein the base portion includes an outer skin contacting portion comprised of a conductive material to provide an external electrode;

means for affixing said base portion to a patient;

means for defining a catheter securing bore on said base portion; and

means for locking said catheter within said bore.

6. A catheter system including:

at least one spring wound multiple electrode stimulation catheter, comprising,

a helically wound spring of an electrically conductive material having distal and proximal ends, said spring defining an interior lumen of said catheter,

a first insulating layer of an electrically insulating material having distal and proximal ends, said first layer covering a portion of said spring, wherein a first electrode is defined by an exposed distal portion of said spring which extends beyond the distal end of said first insulating layer,

a first electrical conductor having distal and proximal ends, the distal end being secured and electrically connected to said first electrode at the distal end, extending through said interior lumen and being secured to the spring adjacent the proximal end,

a wire of electrically conductive material helically wound around a portion of said first insulating layer, said wire being spaced proximately from the distal end of said first insulating layer,

a second insulating layer of an electrically insulating material having distal and proximal ends, said second layer covering a portion of both said helically wound wire and said first insulating layer, wherein a second electrode is defined by an exposed distal portion of said wire which extends beyond the distal end of said second insulating layer, and

a second electrical conductor having distal and proximal ends, the distal end being electrically connected to said second electrode, said second conductor extending between said first and second insulating layers;

at least one stiffening element having a predetermined length and adapted to be freely inserted into the lumen of said catheter; and

at least one securing member adapted to receive and secure said catheter to a patient'"'"'s body, comprising a base portion securable to a patient and a catheter securing means for securing said catheter to said base portion, wherein said catheter securing means comprises a pair of upstanding members disposed adjacent to each other on one side of said base portion and defining a bore between them, wherein the base is adapted to bend, thereby separating the upstanding members for receiving said catheter.

7. A spring wound multiple electrode stimulation catheter comprising:

a helically wound spring inner member, comprising a plurality of coils and having distal and proximal ends, wherein at least the distal end is an electrically conductive material and wherein said inner member defines an inner lumen of said catheter;

a first insulating layer covering less than all of said inner member, wherein the distal end of said inner member is exposed to define a first, flexible helically wound electrode and wherein said first electrode comprises a first proximal portion having closely wound helices, a second central portion having spread apart helices to

define a passage for fluid communication with said lumen, and a third distal portion having closely wound helices;

a second flexible electrode, disposed around said first insulating layer and spaced proximally a predetermined distance from said first electrode; and

a second insulating layer around said catheter beginning at the second electrode and extending to the proximal end of the inner member.

8. The catheter according to claim 7, further comprising:

a first electrical conductor having distal and proximal ends, the distal end being secured and electrically connected to said first electrode at the distal end, extending through said interior lumen and being secured to said helically wound spring adjacent to the proximal end; and

a second electrical conductor having distal and proximal ends, the distal end being electrically connected to said second electrode, said second conductor extending between said first and second insulating layers.

9. The catheter according to claim 7, wherein said second electrode is defined by five to twenty five coils of said second spring.

10. The catheter according to claim 7, wherein the distal end of said first helically wound spring forms a spherically shaped tip.