Package for an active medical device

• US 5,246,109 A
• Filed: 05/22/1992
• Issued: 09/21/1993
• Est. Priority Date: 05/22/1992
• Status: Expired due to Fees

• Current Assignee: Medtronic Minimed Incorporated (Medtronic Plc)
• Original Assignee: Biomedical Sensors Limited (Allegro Biodiesel Corp.)
• Inventors: Markle, David R., Hendry, Stuart P., Irvine, Michael P.
• Primary Examiner(s): PRICE, WILLIAM
• Application Number:
  US07/888,569
• Time in Patent Office: 487 Days
• Field of Search: 439/912, 439/909, 385/56, 206/328, 206/329, 206/438, 206/439, 206/363
• US Class Current: 206/363
• CPC Class Codes: A61B 2050/005 with a lid or cover
• CPC Class Codes: A61B 5/145 Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissuemeasuring of blood pressure or blood flow A61B5/02; non-radiation detecting or locating of foreign bodies in blood A61B5/06
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 50/33 Trays
• CPC Class Codes: Y10S 439/912 with testing means

Abstract

A package for an active medical device has a film member pocket recess. The member has a planar flange about the recess and a flat wall with an opening. A lid attaches to the flange. Outer and inner parts of a junction conjugate in the opening to seal and insure sterility. Test means on the inner part test means include a transparent window in a central web to permit optical signal transmission and electrical signals pass through a plurality of spaced apart electrically conductive pins about the web to distally couple the device and test linkage. An inner part band with a brim thereabout fits through the opening so the brim faces the wall. An outer part collar with a rim thereabout conjugates with the band that extends through the opening and the rim abuts in tight facing relation the wall. The brim and band support a resilient gasket for compression between the wall and the brim when threads on the band mate with threads on the collar. An assembly method entails making an opening in the package wall, placing a gasket against the brim, inserting the band through the opening and installing the collar on the band to form a sterile barrier with threads. A test method entails inserting the device in the recess, attaching the device to the junction, applying energy to the connection from outside and receiving modified energy from the device.

Claims

1. A package for an active medical device having its conductors between the distal and proximal ends thereof comprising:

a film member having a pocket formed therein to define a recess shaped to receive the active medical device, the film member with a flange in a plane about the recess;

a wall of the recess formed as part of the pocket, the wall having at least a flat portion generally perpendicular to the plane of the flange;

an opening in the flat portion for providing access from the recess to the outside of the pocket;

a lid to cover the recess of the pocket and enclose the active medical device, the lid associated with the flange of the film member and thereby contain the active medical device within a sterile field in the recess therein, and

a junction mounted through the flat portion of the wall of the pocket to assure the sterile field within the lidded recess, the junction including test means for the conductors of the medical device so that electrical and optical transmissions pass through the junction without removal of the lid or breach of the sterile field.

2. The package of claim 1 wherein the junction includes a inner part and an outer part which conjugate over the opening to seal the opening and insure sterility within the recess.

3. The package of claim 2 wherein the test means are on the inner part and have a central web including a window of transparent material for permitting optical signal transmission therethrough so the active medical device can fit thereto in position to transmit light signals from the conductors.

4. The package of claim 3 wherein the transparent window has thereabout a plurality of spaced apart electrically conductive pins as another part of the test means which distally couple with the test equipment.

5. The package of claim 2 wherein the inner part includes a band with a brim thereabout so the band fits through the opening and the brim faces the wall about the opening.

6. The package of claim 5 wherein the outer part includes a collar with a rim thereabout so the collar conjugates with the band of the inner part that extends through the opening and the rim abuts in tight facing relation the wall about the opening.

7. The package of claim 6 wherein the brim joins the band to support a gasket thereabout, the gasket of a resilient material for compression between the wall and the outer part 34 when the inner and outer parts are conjugate.

8. The package of claim 7 wherein threads about the band of the inner part that extends through the opening mate with complimentary threads on the collar of the outer part so that the inner and outer parts may be drawn together along their align axis to compress the gasket against the wall.

9. A package for an active medical device having its conductors between the distal and proximal ends thereof comprising:

a film member having a pocket formed therein to define a recess shaped to receive the active medical device, the film member with a flange in a plane about the recess;

a wall of the recess formed as part of the pocket, the wall having at least a flat portion generally perpendicular to the plane of the flange;

an opening in the flat portion for providing access from the recess to the outside of the pocket;

a lid to cover the recess of the pocket and enclose the active medical device, the lid associated with the flange of the film member and thereby contain the active medical device within a sterile field in the recess therein;

a junction mounted through the flat portion of the wall of the pocket to assure the sterile field within the lidded recess, the junction including an inner part and an outer part which conjugate over the opening to seal the opening and insure sterility within the recess, the inner part including test means for the conductors of the medical device so that electrical and optical transmissions pass through the junction without removal of the lid or breach of the sterile field;

a band with a brim thereabout on the inner part so the band fits through the opening and the brim faces the wall about the opening;

a collar with a rim thereabout on the outer part so the collar conjugates with the band of the inner part that extends through the opening and the rim abuts in tight facing relation the wall about the opening;

a gasket supported on the brim whereat it joins the band, the gasket of a resilient material for compression between the wall and the outer part 24 when the inner and outer parts are conjugate;

threads about the band of the inner part that extends through the opening mate with complimentary threads on the collar of the outer part so that the inner and outer parts may be drawn together along their align axis to compress the gasket against the wall;

a central web included in the test means;

a window of transparent material in the central web for permitting optical signal transmission therethrough so the active medical device can fit thereto in position to transmit light signals from the conductors, and

a plurality of spaced apart electrically conductive pins located about the window, the plurality of spaced apart electrically conductive pins being another part of the test means which distally couple with the test equipment.