Neural stimulator with percutaneous connectivity

• US 8,655,455 B2
• Filed: 09/30/2010
• Issued: 02/18/2014
• Est. Priority Date: 10/13/2009
• Status: Active Grant

• Current Assignee: IRRAS USA, Inc. (Irras AB)
• Original Assignee: IncuMED, LLC
• Inventors: Mann, Alfred E., He, Tom Xiaohai
• Primary Examiner(s): Wieland, Robert N
• Application Number:
  US13/500,731
• Publication Number:
  US 20120203318A1
• Time in Patent Office: 1,237 Days
• Field of Search: 607/116, 607/3, 623/32
• US Class Current: 607/116
• CPC Class Codes: A61M 2039/0261 Means for anchoring port to the body, or ports having a special shape or being made of a specific material to allow easy implantation/integration in the body
• CPC Class Codes: A61M 2039/0267 comprising sensors or electrical contacts
• CPC Class Codes: A61M 39/0247 Semi-permanent or permanent transcutaneous or percutaneous access sites to the inside of the body peritoneal dialysis catheters A61M1/285; tracheostomy devices A61M16/0465; measuring pressure within the body A61B5/03; colostomy devices A61F5/445; gastrotomy feeding tubes A61J15/0015; means for fixing a feeding tube outside of the body A61J15/0053
• CPC Class Codes: A61N 1/0536 Preventing neurodegenerative response or inflammatory reaction
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36128 Control systems

Abstract

An implantable neurostimulation system includes both implantable and external components. Electrical connectivity between the external and implanted components is achieved through a plurality of feedthrough pins located within an insulative wall of a percutaneous port embedded in the skin. The percutaneous port has the general shape and appearance of a small thimble, embedded in the skin with its open end facing outwardly from the skin surface, and with its closed end located below the skin surface, thereby forming a cavity or dimple in the skin. Various plugs or cartridges can be removably inserted into the cavity of the percutaneous port, in various orientations, to facilitate appropriate connectivity between the external and implanted components of the system through selected ones of the feedthrough pins. A mesh edging secured around the periphery wall of the port promotes tissue ingrowth and vascularization, thereby forming a percutaneous seal around the port that prevents infection.

Claims

1. A percutaneous implant system comprising:

a percutaneous port, said percutaneous port comprising

a bowl-like receptacle adapted to be embedded on or in the skin, including a tubular member that defines a cavity with an open end and a bottom wall formed at least in part by an insulative plate that defines a closed end, the insulative plate having an inside surface open to areas above said skin by way of said cavity and an outside surface exposed to living tissue below said skin;

a plurality of feedthrough pins extending through said insulative plate, each feedthrough pin having a conductor that allows electrical connection to be established between a proximal end and a distal end of each feedthrough pin, the proximal end of each feedthrough pin extending above the inside surface of the insulative plate and terminating at a point adjacent to the inside surface of the insulative plate, and the distal end of each feedthrough pin extending below the outside surface of the insulative plate into said living tissue;

a mesh material disposed around a periphery of said bowl-like receptacle, said mesh material comprising a biocompatible material configured to promote tissue ingrowth and vascularization;

an external part including a plug, the plug being configured to be removably inserted into the cavity of said percutaneous port and having a plurality of conductors that are positioned to make electrical contact with the proximal ends of said feedthrough pins when said plug is inserted into said bowl-like receptacle and to electrically disconnect from said feedthrough pins when said plug is removed from said bowl-like receptacle; and

an implanted part connected to the distal end of at least one of said feedthrough pins;

wherein said mesh material in combination with living tissue that grows and vascularizes therein provides a protective seal around said insulative plate for protecting against infection.

2. The percutaneous implant system as defined in claim 1 wherein when tissue has grown into the mesh material on the bowl-like receptacle the bowl-like receptacle resembles a dimple or indentation in the skin with most of the volume of the cavity residing below skin level.

3. The percutaneous implant system as defined in claim 1 wherein the plug includes a plurality of wires having a distal end terminating at the conductors within the plug, whereby the plug comprises the distal end of a connector of a cable and the plurality of wires comprise a body of the cable, and wherein a proximal end of the cable may be electrically connected to desired equipment used with the implant system for pulse generation, diagnostics, programming, or recharging purposes.

4. The percutaneous implant system as defined in claim 3 further including

a plurality of implanted leads, each having a proximal end and a distal end, and an insulated conductor connecting the proximal end to the distal end;

an electrode connected to the distal end of each implanted lead;

the proximal end of each lead being connected to the distal end of one of said feedthrough pins, and the distal end of each lead with its electrode being implanted so as to be adjacent a desired target tissue location;

wherein when the proximal end of the cable is connected to an external pulse generator, and when the plug located at a distal end of the cable is inserted into the cavity of the percutaneous port, pulse stimulation is directed from the external pulse generator to a selected target tissue location through at least one of said implanted leads as a function of the relative location of the conductors embedded within the plug relative to the proximal end of the feedthrough pins.

5. The percutaneous implant system as defined in claim 4 wherein the target tissue location is manually selected through rotation of the plug within the percutaneous port.

6. The percutaneous implant system as defined in claim 1 wherein the implanted part of the percutaneous implant system includes at least a first implantable housing wherein electrical stimulation circuitry and a replenishable power source are housed, and wherein the external part of the percutaneous implant system selectively includes power circuitry for replenishing the power source housed within the first implantable housing.

7. The percutaneous implant system as defined in claim 6 wherein the external part of the percutaneous implant system further selectively includes programming circuitry for programming the electrical stimulation circuitry housed within the first implantable housing.

8. The percutaneous implant system as defined in claim 1 wherein the implanted part of the percutaneous implant system includes at least a first implantable housing wherein electrical stimulation circuitry is housed and a second implantable housing wherein a replenishable power source is housed, and wherein both the first and second housings are electrically connected to the distal ends of respective feedthrough pins of the percutaneous port, and wherein the external part of the percutaneous implant system selectively includes (a) programming circuitry for programming the operation of the electrical stimulation circuitry housed within the first implantable housing, (b) power circuitry for replenishing the power source housed within the second implantable housing or (c) diagnostic circuitry for testing the operation of the electrical stimulation circuitry.

9. In an implantable medical system comprising implanted components and external components, a percutaneous port for providing direct electrical connection between the implanted components and external components, the percutaneous port comprising:

a bowl-like receptacle configured to be embedded in the skin of a user of the implanted medical system, said bowl-like receptacle having

an upper rim that defines a periphery of the receptacle, and

a wall extending down from the upper rim and formed to define a single cavity adapted to receive a single removable plug and having a closed bottom inside said rim, at least a portion of said wall comprising an insulative plate;

three or more feedthrough pins extending through the insulative plate into said single cavity, each feedthrough pin having a proximal end and a distal end and an electrical conductive body that connects the proximal end and the distal end, the proximal end comprising the end of the feedthrough pin accessible from the inside of the cavity of the percutaneous port, and the distal end comprising the end of the feedthrough pin accessible from the outside of the cavity of the percutaneous port;

a mesh material disposed around a periphery of said upper rim, said mesh material comprising a biocompatible material configured to promote tissue ingrowth and vascularization;

wherein said percutaneous port is configured to be embedded in the skin of a user so that the upper rim of the percutaneous port is even with, or extends slightly above, a surface of the skin, and so that the volume of the cavity defined by the walls of said percutaneous port lies largely below skin level so as to form a dimple or indentation in the skin;

wherein the wall of said percutaneous port protects tissue under the skin from exposure and infection; and

wherein the mesh material provides a location where living tissue can grow into the mesh material and provide a barrier around the periphery of the percutaneous port that protects the tissue from infection; and

further

wherein direct electrical connection may be established between external components of the implanted medical system and implanted components of the implanted medical system through said feedthrough pins passing through the wall of said percutaneous port.