Spinal electrode catheter

• US 5,374,285 A
• Filed: 07/30/1993
• Issued: 12/20/1994
• Est. Priority Date: 07/31/1992
• Status: Expired due to Fees

• Current Assignee: Aries SRL (Datamatic S.p.A.)
• Original Assignee: Aries SRL (Datamatic S.p.A.)
• Inventors: Borghi, Enzo, Vaiani, Paolo, Gibelli, Claudio
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): SCHAETZLE, KENNEDY
• Application Number:
  US08/100,049
• Time in Patent Office: 508 Days
• Field of Search: 607/117, 607/116, 607/115, 607/120, 607/122, 128/642, 29/857, 29/850, 29/861
• US Class Current: 607/117
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: Y10T 29/49162 by using wire as conductive path
• CPC Class Codes: Y10T 29/49174 Assembling terminal to elongated conductor

Abstract

The electrode catheter comprises a flexible spiral wound element accommodated coaxially within and extending the entire length of a first sheath such a way as to provide a core ensuring rigidity, for the purposes of the initial implantation, and flexibility to allow subsequent adaptation of the catheter to the subcutaneous cavity ultimately occupied. The spiral wound element carries a set of wires, each bared at the distal end, which break out of respective holes in the sheath to connect with relative terminals or sensors; each bared end is flattened against a corresponding first ring crimped coaxially to the sheath alongside the relative hole, and sandwiched between this same ring and a second ring of electrically conductive and biocompatible material by which the sensor or electrode is fully encapsulated.

Claims

1. A spinal electrode catheter for the subcutaneoas stimulation of areas of the vertebral column and the spinal bone marrow, comprising at least one first tubular outer sheath fashioned in biocompatible material, stopped at one end and insertable into a subcutaneous vertebral area and accommodating a set of electrically conductive wires disposed substantially parallel one with another and insulated individually by respective second sheaths, each of which connected by one end to a corresponding terminal or sensor positioned externally of the first sheath in such a way as to establish an electrode, and by the remaining end to a stimulator, and further comprising:

a flexible spiral wound element associated co-axially with and extending substantially the full length of the first sheath in such a way as to establish an internal core by which the sheath is invested with rigidity during insertion into the subcutaneous area and with flexibility allowing adaptation of the electrode catheter to the cavity ultimately occupied following implantation, while functioning as a support for said wires of which the ends associated with the sensors are bared from their insulating sheaths and caused to emerge from the first outer sheath by way of corresponding breakout holes;

a first contact ring associated with each of the wires, positioned adjacent to the relative breakout hole and secured coaxially to the first sheath in such a manner as to afford a support against which the bared end of the wire is bent and flattened;

a second encapsulating ring associated with each wire, fashioned from electrically conductive and biocompatible material and secured over the bared and flattened end of the wire and the first ring in such a way as to complete the composition of the sensor or electrode.

2. An electrode catheter as in claim 1, wherein each electrode assembly also comprises biocompatible sealing means positioned to coincide with the second encapsulating rings and consisting of a biocompatible medical adhesive, in which the second ring, the bared end of the relative wire, the first ring and the corresponding part of the first sheath are permanently embedded.

3. An electrode catheter as in claim 1, wherein the flexible element consists of a spiral wound metal wire connected to the stopped end of the first outer sheath.

4. An electrode catheter as in claim 1, wherein each of the first contact rings is positioned or the proximal side of the emerging wire in relation to the distal stopped end of the first outer sheath.

5. An electrode catheter as in claim 1, wherein the sensor or second ring nearest the stopped end of the first outer sheath is connected electrically to the end of said flexible spiral wound element, said element consisting of an electrically conductive material and of internal diameter or width such as to allow the passage of a coaxial mandrel or stylet.

6. An electrode catheter as in claim 1, wherein the distances between centers of adjacent sensors or electrodes are dissimilar one from another.

7. An electrode catheter as in claim 5, wherein at least the sensor or electrode nearest the stopped end of the first outer sheath is pierced with a plurality of holes serving to allow an infusion of drugs conveyed by way of the catheter.

8. An electrode catheter as in claim 1, wherein the tubular outer sheath affords a plurality of holes distributed uniformly along its length, serving to allow an infusion of drugs conveyed by way of the catheter.

9. A method of assembling an electrode catheter as in claim 1, comprising the steps of:

inserting the wires into the tubular outer sheath in such a way that each bared end is positioned adjacent to a respective hole;

coaxially inserting the spiral wound element into and through substantially the entire length of the sheath;

positioning and securing the first contact rings at points adjacent to the bared ends of the wires, then bending and flattening at least the bared end of each wire against the relative ring;

positioning and securing the second rings over the first rings such that the bared end of each wire remains sandwiched between the relative rings.

10. A method of assembling an electrode catheter as in claim 9, comprising the further step, implemented concurrently with that of positioning and securing the second rings, of applying sealing means to each of the assemblies comprising a second ring, the bared end of a wire and a first contact ring.

11. A method of assembling an electrode catheter as in claim 2 comprising the steps of:

inserting the wires into the tubular outer sheath in such a way that each bared end is positioned adjacent to a respective hole;

coaxially inserting the spiral wound element into and through substantially the entire length of the sheath;

positioning and securing the first contact rings at points adjacent to the bared ends of the wires, then bending and flattening at least the bared end of each wire against the relative ring;

positioning and securing the second rings over the first rings such that the bared end of each wire remains sandwiched between the relative rings.

12. A method of assembling an electrode catheter as in claim 3 comprising the steps of:

inserting the wires into the tubular outer sheath in such a way that each bared end is positioned adjacent to a respective hole;

coaxially inserting the spiral wound element into and through substantially the entire length of the sheath;

positioning and securing the first contact rings at points adjacent to the bared ends of the wires, then bending and flattening at least the bared end of each wire against the relative ring;

positioning and securing the second rings over the first rings such that the bared end of each wire remains sandwiched between the relative rings.

13. A method of assembling an electrode catheter as in claim 4 comprising the steps of:

inserting the wires into the tubular outer sheath in such a way that each bared end is positioned adjacent to a respective hole;

coaxially inserting the spiral wound element into and through substantially the entire length of the sheath;

positioning and securing the first contact rings at points adjacent to the bared ends of the wires, then bending and flattening at least the bared end of each wire against the relative ring;

positioning and securing the second rings over the first rings such that the bared end of each wire remains sandwiched between the relative rings.

14. A method of assembling an electrode catheter as in claim 5 comprising the steps of:

inserting the wires into the tubular outer sheath in such a way that each bared end is positioned adjacent to a respective hole;

coaxially inserting the spiral wound element into and through substantially the entire length of the sheath;

positioning and securing the first contact rings at points adjacent to the bared ends of the wires, then bending and flattening at least the bared end of each wire against the relative ring;

positioning and securing the second rings over the first rings such that the bared end of each wire remains sandwiched between the relative rings.