Automatically opening medical device package and method of manufacture

• US 20040163987A1
• Filed: 02/25/2003
• Published: 08/26/2004
• Est. Priority Date: 02/25/2003
• Status: Abandoned Application

• Current Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Allen, John
• Application Number:
  US10/374,440
• Publication Number:
  US 20040163987A1
• Time in Patent Office: Days
• US Class Current: 206/438
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• CPC Class Codes: A61B 5/150534 Design of protective means for piercing elements for preventing accidental needle sticks, e.g. shields, caps, protectors, axially extensible sleeves, pivotable protective sleeves
• CPC Class Codes: A61B 50/3001 for sharps

Abstract

An automatically opening medical device package that includes upper and lower flexible sheet portions, each having distal and proximal ends and first and second peripheral edges. These flexible sheet portions are adapted to be detachably sealed together along their peripheral edges, thereby providing for the enclosure of a medical device. Also included is a collar attached to the distal ends such that a relative movement of the collar and the proximal ends, that decreases a distance therebetween, causes the flexible sheet portions to pull apart, opening the package. A method of manufacturing an automatically opening medical device package containing a medical device includes positioning a medical device on an upper surface of a flexible sheet of material that also has a lower surface, and first and second ends. Upper and lower collar precursors are attached to the lower surfaces of the first and second ends, respectively. The flexible sheet of material is subsequently folded end-over-end about the medical device, thereby forming upper and lower flexible sheet portions (each with distal and proximal ends) that enclose the medical device. The flexible sheet portions are then detachably sealed together. The collar precursors are rolled-back across the flexible sheet portions, operatively aligned, and sealed together to form a collar that is attached to the distal ends such that a relative movement of the collar and the proximal ends, that decreases a distance therebetween, results in a pulling apart of the flexible sheet portions, thereby exposing at least a portion of the medical device.

Claims

1. An automatically opening medical device package, the package comprising:

an upper flexible sheet portion having a distal end, a proximal end, a first peripheral edge and a second peripheral edge;

a lower flexible sheet portion having a distal end, a proximal end, a first peripheral edge and a second peripheral edge; and

a collar attached to the distal end of the upper flexible sheet portion and the distal end of the lower flexible sheet portion;

wherein the upper and lower flexible sheet portions are adapted to be detachably sealed together along at least a segment of their first and second peripheral edges, thereby providing for the enclosing of a medical device within the upper and lower flexible sheet portions; and

wherein the collar is attached to the distal ends of the upper and lower flexible sheet portions in a manner such that a relative movement of the collar and the proximal ends of the upper and lower flexible sheet portions, that decreases a distance therebetween, results in a pulling apart of the lower and upper flexible sheet portions, thereby automatically opening the package and exposing at least a portion of the medical device.

2. The package of claim 1, wherein the upper and lower flexible sheet portions are adapted to enclose an integrated biosensor and lancet medical device.

3. The package of claim 1, wherein the upper and lower flexible sheet portions are adapted to enclose a biosensor medical device.

4. The package of claim 1, wherein the upper and lower flexible sheet portions are adapted to enclose a lancet medical device.

5. The package of claim 1, wherein the collar encircles a portion of a medical device enclosed within the upper and lower flexible sheet portions.

6. The package of claim 1, wherein the collar is made of a rigid material.

7. The package of claim 6, wherein the collar is made of cardboard.

8. The package of claim 6, wherein the collar is made of a plastic film.

9. The package of claim 1, wherein the collar is made of a semi-rigid material.

10. The package of claim 1, wherein the proximal ends of the upper and lower flexible sheet portions are joined together.

11. The package of claim 1, wherein the upper and lower flexible sheet portions are portions of a single unitary flexible sheet.

12. The package of claim 1, wherein the upper and lower flexible sheet portions are formed of paper.

13. The package of claim 1, wherein the upper and lower flexible sheet portions are formed of a film.

14. The package of claim 1, wherein the upper and lower flexible sheet portions are formed of plastic.

15. The package of claim 1, wherein the upper and lower flexible sheets are detachably sealed using an adhesive coating.

16. The package of claim 1, wherein the collar is attached to the distal ends of the upper and lower flexible sheet portions such that, following the relative movement of the collar and the proximal ends of the upper and lower flexible sheet portions that decreases a distance therebetween, a subsequent relative movement of the collar and proximal ends of the upper and lower flexible sheets, that increases the distance therebetween, results in an automatic enclosing of the medical device by the upper and lower flexible sheet portions.

17. The package of claim 16, wherein the automatic enclosing results in a re-sealing of the upper and lower flexible sheet portions.

18. An automatically opening medical device package and medical device kit, the kit comprising:

a package, the package including;

an upper flexible sheet portion having a distal end, a proximal end, a first peripheral edge and a second peripheral edge;

a lower flexible sheet portion having a distal end, a proximal end, a first peripheral edge and a second peripheral edge; and

a collar attached to the distal end of the upper flexible sheet portion and the distal end of the lower flexible sheet portion;

wherein the upper and lower flexible sheet portions are adapted to be sealed together along at least a segment of their first and second peripheral edges, thereby providing enclosure for a medical device within the upper and lower flexible sheet portions; and

wherein the collar is attached to the distal ends of the upper and lower flexible sheet portions such that a relative movement of the collar and the proximal ends of the upper and lower flexible sheet portions that decreases a distance therebetween results in a pulling apart of the lower and upper flexible sheet portions, thereby exposing any medical device encased within the upper and lower flexible sheet portions; and

a medical device contained within the package.

19. The kit of claim 18, wherein the medical device is an integrated biosensor and lancet medical device.

20. The kit of claim 19, wherein the integrated biosensor and lancet medical device is adapted for the measurement of blood glucose.

21. An automatically opening medical device package and medical device kit, the kit comprising:

a package, the package including;

an upper flexible sheet portion having a distal end, a proximal end, a first peripheral edge and a second peripheral edge;

a lower flexible sheet portion having a distal end, a proximal end, a first peripheral edge and a second peripheral edge; and

a collar attached to the distal end of the upper flexible sheet portion and the distal end of the lower flexible sheet portion;

wherein the upper and lower flexible sheet portions are adapted to be sealed together along at least a segment of their first and second peripheral edges, thereby providing enclosure for a medical device within the upper and lower flexible sheet portions; and

wherein the collar is attached to the distal ends of the upper and lower flexible sheet portions such that a relative movement of the collar and the proximal ends of the upper and lower flexible sheet portions that decreases a distance therebetween results in a pulling apart of the lower and upper flexible sheet portions, thereby exposing any medical device encased within the upper and lower flexible sheet portions, and such that a subsequent relative movement of the collar and proximal ends of the upper and lower flexible sheets, that increases the distance therebetween, results in an automatic enclosing of the medical device by the upper and lower flexible sheet portions; and

a medical device contained within the package.

22. A method for manufacturing an automatically opening medical device package containing a medical device, the method comprising:

positioning at least one medical device on a flexible sheet of material, the flexible sheet of material having an upper surface, a lower surface, a first end and a second end, the at least one medical device being positioned on the upper surface between the first and second ends;

attaching an upper collar precursor to the lower surface of the first end of the flexible sheet of material and a lower collar precursor to the lower surface of the second end of the flexible sheet of material;

folding the flexible sheet of material end-over-end about the at least one medical device, thereby forming an upper flexible sheet portion and a lower flexible sheet portion enclosing the at least one medical device, each of the upper and lower flexible sheet portions having a distal end and a proximal end;

detachably sealing the upper flexible sheet portion to the lower flexible sheet portion;

rolling-back the upper and lower collar precursors across the upper flexible sheet portion and lower flexible sheet portion, respectively, such that the upper and lower collar precursors are operatively aligned; and

joining the upper and lower collar precursors together to form a collar attached to the distal ends of the upper and lower flexible sheet portions in a manner such that a relative movement of the collar and the proximal ends of the upper and lower flexible sheet portions, that decreases a distance therebetween, results in a pulling apart of the upper and lower flexible sheet portions, thereby automatically exposing at least a portion of the medical device.

23. The method of claim 22, wherein the detachably sealing step forms a sterility barrier.

24. The method of claim 22, wherein the positioning step includes positioning a plurality of medical devices.

25. The method of claim 22 further comprising the step of removing portions of the flexible sheet of material after the sealing step and before the rolling-back step.

26. The method of claim 22, wherein the positioning step includes positioning at least one integrated biosensor and lancet medical device.