HEART STIMULATOR SYSTEM FOR RAPID IMPLANTATION AND REMOVAL WITH IMPROVED INTEGRITY

• US 3,871,382 A
• Filed: 02/15/1973
• Issued: 03/18/1975
• Est. Priority Date: 02/15/1973
• Status: Expired due to Term

• Current Assignee: Siemens-Elema AB (Siemens AG)
• Original Assignee: Alfred E. Mann
• Inventors: Mann, Alfred E.
• Primary Examiner(s): Kamm, William E.
• Application Number:
  US05/332,610
• Time in Patent Office: 761 Days
• Field of Search: 128/404,418,419P,419R,421,422
• US Class Current: 607/37
• CPC Class Codes: A61N 1/3752 Details of casing-lead connections

Abstract

Disclosed is a quick connect-disconnect heart stimulator system including a catheter assembly. The catheter assembly is screwed into the remainder of the system and not only effects positive mechanical coupling, but also positive and resilient electrical connection and fluid-tight sealing, all in one quick operation. The system also permits inserting and removing a catheter positioning stylet without disconnecting the catheter from the remainder of the system with self sealing material preventing entry of body fluids after the stylet is withdrawn.

Claims

1. Heart stimulator system adapted to be implanted within a human body, comprising:

a sealed assembly including a sealed enclosure and pulse generating means housed therewithin, said enclosure defining an open cavity;

a catheter having distal and proximal ends and adapted to be coupled to a human heart adjacent said distal end, with at least one electrode for carrying signals between said pulse generating means and said heart, said catheter defining an axially extending interior space;

elongated catheter support means defining a transverse passageway coaxial with said catheter interior space and communicating therewith at one end while being open at the other end, said support means being joined to said catheter adjacent said proximal end;

pierceable self-sealing means for sealing said other open passageway end of said catheter support means;

quick connect-disconnect means for sealingly and simultaneously coupling mechanically and electrically said assembly to said catheter and support transversely to said passageway into a sealed unit, including a male threaded connector secured to said catheter support means adjacent one end thereof, said connector including a conductive portion therewithin insulated from the remainder of said connector, extending to the leading end thereof, and electrically connected to said one electrode, said catheter and said catheter support means forming an integral elongated lever arm for said threaded connector;

a female threaded connector adapted to receive said male connector therethrough and secured within said cavity at the entrance thereof, said male and female connectors defining an axis upon being united which is transverse to that of said catheter passageway and interior space;

a contact member mounted within said cavity and spaced inwardly from said female connector, said contact member being electrically connected to said pulse generating means, resilient means positioned in said cavity inwardly from said female connector, and responsive to the passage of said male connector through said female connector for sealing said cavity;

said male connector conductive portion thereupon engaging said contact member, effecting electrical as well as mechanical connection with the sealing of said cavity simultaneously, said connection being tensioned with said lever arm to complete a sealed stimulator system which may be equally quickly disassembled and whose catheter may be stylet-positioned without disturbing said connection.

2. A system as in claim 1 in which said pierceable means for sealing includes a plurality of membranes of pierceable resilient self-sealing material serially mounted one behind the other within said passageway, to permit pAssage therethrough of a catheter positioning stylet into said catheter interior space, and a subsequent resealing of said passageway upon removal of such stylet.

3. A system as in claim 1 which further includes means for movably, and resiliently mounting said contact member within said cavity whereby said contact member is positively and resiliently biased into contact with said male member conductive portion upon the coupling of said connectors.

4. A heart stimulator system for rapid and simplified high reliability assembly and implantation within the human body, comprising:

a sealed stimulator assembly including a sealed enclosure and electrical pulse generating means housed therewithin, said enclosure defining an open cavity in the surface thereof, said circuitry having a terminal extending into said cavity at an inner portion thereof;

a sealed catheter assembly adapted to be coupled to a human heart and having an elongated catheter and a catheter support portion joining said catheter adjacent one end thereof, said catheter having at least one electrode for carrying signals between said pulse generating means and said heart;

a male threaded connector sealingly secured at one end thereof to said catheter support portion with the connector axis transverse to that of said catheter, said connector defining a central axial aperture therethrough;

a female threaded connector adapted to receive said male connection therethrough and secured within said cavity so as to occupy the cavity entrance, said circuitry terminal being spaced from said female connector;

electrical contact means coaxial with said connectors and operative simultaneously therewith, said means including a conductor member carried within said axial aperture of said male connector and insulated from said male connector, said conductor member being electrically connected adjacent said one connector end to said electrode, said conductor member extending outwardly from the other, leading connector end into a sharp outward projection; and

a contact member movably mounted within said cavity spaced inwardly of and coaxially with said female connector, said contact member being electrically connected to said terminal;

a resilient annular seal positioned in said cavity coaxially with said female connector and inwardly thereof in contact with the wall of said cavity, said seal engaging said conductor upon the passage of said male connector through said female connector;

spring means for urging said contact member toward said female connector, said conductor engaging said seal and compressing it between said end and said wall while said conductor projection engages said contact member upon said connectors being united, whereby said stimulator and catheter assemblies are simultaneously electrically and mechanically connected as well as sealed into a unitary fluid tight system.

5. A heart stimulator system as in claim 4 in which said catheter support portion includes an elongated connector arm extending transversely and substantially across said support parallel to said catheter, and to which said male connector is secured at one connector arm end, said arm extending under said one catheter end, said arm including a clip at the end opposite said male connector, said clip securing said catheter upon said arm, and means potting said connector arm and clip with said one catheter end into an integral assembly to form a lever arm for said male connector adapted to aid in tightening said connectors and ensure high contact forces between said projection and said contact member.

6. A system as in claim 5 in which said catheter support portion includes a terminal member mounted on said arm and insulated therefrom, in a position opposite said male connector so that said arm is therebetween, said terminal being connected electrically to said conductive portion of said male member, as well as to said catheter electrode.

7. A system as in claim 6, in which a passageway is defined thrOugh said terminal member and in which said catheter defines an interior axially extending space, said passageway and space being coaxial and extending transversely to the axis of said male connector, and which further includes a plurality of membranes of pierceable resilient, self-sealing material serially mounted within said passageway, thereby sealing said catheter and passageway yet permitting the passage therewithin of a positioning stylet and insuring subsequent resealing upon removal of such stylet.

8. A heart stimulator system as in claim 4 in which said conductor member projection comprises an annular knife edge, and said contact member includes a flat surface facing said annular knife edge, whereby said knife edge digs into said contact surface for optimum contact upon said connectors being united.

9. A heart stimulator system as in claim 4 wherein said contact member includes a lower end section having at least one flat side to limit the rotational excursion of said contact member.

10. A heart stimulator system as in claim 4 wherein said contact member includes a flanged surface facing said sharp projection, and said seal is captured between the periphery of said flange and said cavity wall, said spring member biasing said contact member beneath said flange.