Tissue stimulator with sealed lead connector

• US 3,908,668 A
• Filed: 04/26/1974
• Issued: 09/30/1975
• Est. Priority Date: 04/26/1974
• Status: Expired due to Term

• Current Assignee: Lee R. Bolduc
• Original Assignee: Lee R. Bolduc
• Inventors: Bolduc, Lee R.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/464,488
• Time in Patent Office: 522 Days
• Field of Search: 128/419C,419E,419P,419R 339/6R,65,66R,75R,272A,272R 85/1K,1SS
• US Class Current: 607/37
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections
• CPC Class Codes: H01R 4/36 Conductive members located under tip of screw

Abstract

A method and apparatus for connecting a lead to a pulse generator for producing and applying electrical stimulation pulses to remote body tissue. The lead connector is associated with the pulse generator and is engageable and operable by a tool to connect the lead to the pulse generator and comprises sealing means puncturable by the tool in engagement with the connector and resealable upon removal of tool for providing a sterilizeable, insulating, inert seal between the connector and body tissue. In addition, the tool further comprises means for preventing the application of too great a force to the lead connector to prevent its damage. The lead connector may further comprise a receptacle for receiving the lead and retaining means associated with the receptacle and engageable by the tool for retaining the lead in the receptacle. In addition, the retaining means may further comprise means movable by the tool into contact with the lead for retaining the lead in stationary relationship in the receptacle, and the receptacle may further comprise means for preventing the release of the movable means by the tool from the receptacle.

Claims

1. In combination with a tissue stimulator having pulse generator means for producing tissue stimulation pulses, housing means of a surface material compatible with the human body as an environment enclosing said pulse generator means, lead means adapted to conduct the stimulation pulses to body tissue remote from said pulse generator means upon connection of said lead means to said pulse generator means and lead connector means coupled with said pulse generator means and situated at a predetermined position within said housing means engageable by tool means in the operation of connecting said lead means to said pulse generator means;

the improvement comprising;

sealing means of a homogeneous material compatible with the human body as an environment puncturable by said tool means to engage said connecter means and resealable upon removal of said tool means for providing an inert, electrically insulating seal between said connector means and body fluids and tissues, said sealing means being conformed to extend from the surface of said housing means through a gap in said housing means to said predetermined position of said connector means and in contact therewith; and

means associated with said housing means for maintaining said sealing means in fixed contact with said housing means and said connector means.

2. The tissue stimulator of claim 1 wherein said lead connector means further comprises:

a. receptable means for receiving said lead means; and

b. retaining means associated with said receptacle means and engageable by said tool means for retaining said lead means in said receptacle means.

3. The tissue stimulator of claim 2 wherein said retaining means further comprises means movable by said tool means into contact with said lead means for retaining said lead means in stationary relationship in said receptacle means;

and said receptacle means further comprises means for preventing the release of said movable means by said tool means from said receptacle means.

4. The tissue stimulator of claim 1 wherein said sealing means comprises an implantable grade silicone rubber compound.

5. In combination with a tissue stimulator having pulse generator means for producing stimulation pulses, housing means of a surface material substantially inert to body fluids and tissue enclosing said pulse generator means, lead means adapted to conduct the stimulation pulses to remote body tissue upon connection of the lead means to the pulse generator means, said lead means having an electrically conductive connector pin at its proximal end to be electrically connected to said pulse generator means, and lead connector apparatus coupled with said pulse generator means and situated at a predetermined position within said housing means engageable by tool means in the operation of connecting said lead means to said pulse generator means, said lead connector means further comprising electrically conductive, receptacle means for receiving said connector pin, and retaining means associated with said receptacle means engageable by said tool means for retaining said connector pin in electrically conductive, stationary relationship in said receptacle means;

the improvement comprising;

sealing means of a homogeneous material compatible with the human body as an environment puncturable by said tool means to engage said retaining means and resealable upon remoVal of said tool means for providing an inert, electrically insulating seal between said receptacle means and said retaining means and body fluids and tissues, said sealing means being conformed to extend from the surface of said housing means through a gap in said housing means to said predetermined position of said connector means and in contact therewith; and

means associated with said housing means for maintaining said sealing means in fixed contact with said housing means and said receptacle means.

6. The tissue stimulator of claim 5 wherein said lead means further comprises an electrically insulated conductor having a conductive stimulating electrode at its distal end and said electrically conductive connector pin at its proximal end.

7. The tissue stimulator of claim 6 wherein said pulse generator means further comprises a source of electrical energy and electrical circuit means connected to said source of electrical energy for producing periodic, electrical stimulation pulses, and said housing means comprises encapsulating means substantially inert to body fluids and tissue for enclosing and covering said source of electrical energy and said electrical circuit means;

and wherein said lead connector means further comprises resilient boot means substantially inert to body fluids and tissue and associated with said receptacle means for guiding said connector pin to said receptacle means and engageable with the electrical insulated conductor at its distal end for inhibiting the entrance of body fluids and tissue into said receptacle means.

8. The tissue stimulator of claim 5 wherein said sealing means comprises a layer of an implantable grade silicone rubber compound.

9. The tissue stimulator of claim 5 wherein said retaining means further comprises movable means engageable by said tool means and responsive to rotation of said tool means in a first direction to move into contact with and retain said connector pin in said receptacle means.

10. The tissue stimulator of claim 9 wherein said retaining means further comprises means associated with said retaining means for preventing said movable means from being released from said retaining means upon engagement by said tool means and by turning said movable means in the second direction.

11. In combination with a tissue stimulator having pulse generator means for producing periodic, stimulation pulses, housing means of a surface material substantially inert to body fluids and tissue enclosing said pulse generator means, lead means adapted to conduct the stimulation pulses to remote body tissue upon connection of the lead means to said pulse generator means, said lead means comprising an electrically insulated conductor having a conductive stimulating electrode at its distal end and an electrically conductive, elongated connector pin at its proximal end adapted to be electrically connected to said pulse generator means and lead connector means coupled with said pulse generator means and situated at a predetermined position within said housing means engageable by driving tool means in the operation of connecting said lead means to said pulse generator means, said lead connector means further comprising electrically conductive, connector block means having an elongated receptacle for receiving said connector pin and a threaded bore extending perpendicular to and from said receptacle through said connector block means and screw means threaded in said threaded bore and engageable by said tool means for turning said screw means in a first direction to make electrical contact with and tighten said connector pin in said receptacle;

the improvement comprising;

sealing means of a homogeneous material compatible with the human body as an environment puncturable by said tool means to engage said connector block means and resealable upon removal of said tool means for providing an inert, electrically insulating seal between said connector block means and body fluids and tissue, said sealing means being conformed to extend from the surface of said housing means through a gap in said housing means to said predetermined position of said connector means and in contact therewith; and

means associated with said housing means for maintaining said sealing means in fixed contact with said housing means and said connector means.

12. The tissue stimulator of claim 11 wherein said connector block means further comprises means in contact with said threaded bore for preventing the removal of said screw means from said threaded bore when said screw means is turned in a second direction upon engagement by said tool means.

13. The tissue stimulator of claim 11 wherein said pulse generator means further comprises a source of electrical energy and electrical circuit means connected to said source of electrical energy for producing the periodic, electrical stimulation pulses, and said housing means comprises encapsulating means substantially inert to body fluids and tissue for enclosing and covering said source of electrical energy and said electrical circuit means;

and wherein said lead connector means further comprises resilient boot means substantially inert to body fluids and tissue and associated with said receptacle means for guiding said connector pin to said receptacle and engageable with the electrical insulated conductor at its distal end for preventing the entrance of body fluids and tissue into said receptacle.

14. The tissue stimulator of claim 11 wherein said sealing means comprises a layer of an implantable grade silicone rubber compound.

15. The tissue stimulator of claim 11 wherein said screw means and said connector block means are composed of a relatively hard, corrosion resistant metal.