Medical device packaging and antistatic system

• US 20060186010A1
• Filed: 02/14/2006
• Published: 08/24/2006
• Est. Priority Date: 02/15/2005
• Status: Abandoned Application

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Phelan, Jim, Forde, Eddie, Warnack, Boris
• Application Number:
  US11/353,612
• Publication Number:
  US 20060186010A1
• Time in Patent Office: Days
• US Class Current: 206/438
• CPC Class Codes: A61B 2050/314 Flexible bags or pouches
• 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: A61M 25/002 Packages specially adapted therefor combined with means for introducing catheters, e.g. dispensers, A61M25/0113; catheter kit packages for surgical articles A61B50/30
• CPC Class Codes: Y10T 428/13 Hollow or container type article [e.g., tube, vase, etc.]

Abstract

An elongate medical device packaging system can include a sheath, a clasp, and/or a container. The sheath can be configured to releasably retain an elongate medical device, and can be comprised of a first material and an antistatic material in an amount and distribution within the first material so as to inhibit generating static electricity when the elongate medical device is withdrawn from the lumen. The clasp can include at least two recesses configured to hold the sheath in a coiled orientation. The clasp also has a configured to hold at least one object in an inwardly planar orientation with respect to the coiled elongate tube. The container can be a multi-compartment container, which includes one compartment to hold the coiled sheath and one compartment to hold components of the medical device, wherein each compartment can be fluid-tight.

Claims

1. A medical device storage apparatus, the apparatus comprising:

a housing having an outer end and an inner end;

in the housing at least two recesses each configured for releasably retaining an elongate packaging tube in at least a double coil orientation so that a coil passes through each one of the recesses, the recesses being substantially parallel with respect to each other; and

a holder having an inward end and an outward end that is coupled with the inner end housing and configured for releasably retaining at least one object in an inwardly planar orientation with respect to the coiled elongate packaging tube, wherein the storage apparatus retains the coiled elongate packaging tube and object in a substantially planar orientation.

2. A storage apparatus as in claim 1, wherein the at least two recesses are formed into a single side of the housing.

3. A storage apparatus as in claim 1, wherein one of the at least two recesses is disposed toward the inner end of the housing with respect to the other elongate recess.

4. A storage apparatus as in claim 1, wherein the holder is configured to releasably retaining at least one substantially planar substrate.

5. A storage apparatus as in claim 4, wherein the holder is at least one of a pressure clip, friction clip, crocodile clip, or tongue-and-groove clip.

6. A storage apparatus as in claim 1, wherein the holder is configured to releasably retaining at least one cylindrical component that is usable with the elongate medical device.

7. A storage apparatus as in claim 1, wherein the cylindrical component is a needle cap containing a flushing needle.

8. A storage apparatus as in claim 6, wherein the holder is at least one of a pressure clip, friction clip, circular friction clip, “

U”

friction clip, or crocodile clip.

9. A storage apparatus as in claim 6, further comprising a bar coupled to inward end of the holder, the bar being configured to releasably retain at least one catheter retaining clip when coupled therewith.

10. A storage apparatus as in claim 9, wherein the bar is includes a middle portion and two end-caps, the middle portion forming a “

T”

intersection with the holder, and the two end-caps being spaced from the middle section by a length that accommodates at least one catheter retaining clip between the “

T”

intersection and each end-cap.

11. A storage apparatus as in claim 1, wherein an external surface of the storage apparatus is shaped with rounded features that inhibit perforation of a polymeric package enclosing the medical device.

12. A storage apparatus as in claim 1, further comprising a secondary holder coupled with the outer end of the housing, the secondary holder being comprised of an arm having an off-axis bend and at the end of the arm a recess configured for releasably retaining a cylindrical portion of the elongate medical device extending from the elongate packaging tube.

13. A storage apparatus as in claim 12, wherein the cylindrical portion is a portion of a flushing luer.

14. A storage apparatus as in claim 11, wherein the housing includes an effective amount of an antistatic material.

15. A medical device sheath comprising;

an elongate tube having an outer surface and an inner surface defining a lumen to receive an elongate medical device, the elongate tube being comprised of a first material and an antistatic material in an amount and distribution so as to inhibit generating static when the elongate medical device is withdrawn from the lumen.

16. A sheath as in claim 15, wherein the antistatic material is selected from the group consisting of polytetrafluoroethylene, fluorinated ethylene-propylene polymer, carbon-filled polymer, glycerolmonostearate, ethoxylated alkylamine, nonionic ethoxylated alkylamine, lauric diethanol amine, alkyl sulfonates, alkyl dimethyl benzyl ammonium chloride/bromide, anionic aliphatic sulfonate/phosphates, quaternary ammonium compounds, glass-impregnated polystyrene, glass-impregnated acrylonitrile butadiene styrene polymers, antistatic polycarbonate, cationic scavengers, and combinations thereof.

17. A sheath as in claim 16, wherein the antistatic material is selected from the group consisting of polytetrafluoroethylene, fluorinated ethylene-propylene polymer, carbon-filled polymer, glycerolmonostearate, ethoxylated alkylamine, and combinations thereof.

18. A sheath as in claim 15, wherein the first material is polyethylene or high-density polyethylene.

19. A sheath as in claim 15, further comprising a hydroscopic scavenger.

20. A sheath as in claim 19, wherein the hygroscopic scavenger is selected from the group consisting of phosphorous pentoxide, ethanol, methanol, glycerin, sodium hydroxide, H₂SO₄, ZnSO₄, CaCl₂, SiO₂, NaNO₃, CaSO₄, and combinations thereof.

21. A multi-compartment container for packaging a medical device, the container comprising:

a top outer sheet having a first end and a second end;

a bottom outer sheet sealed to the top outer sheet around a peripheral edge to define a first compartment;

an inner insert sheet disposed between the top outer sheet and the bottom outer sheet, the inner insert sheet extending from the first end towards the second end and terminating distal from the second end to define a second compartment, the inner insert comprising at least two sections of differing materials.

22. A container as in claim 21, wherein a first section of the at least two sections is comprised of a heat-pressed continuous high-density polyethylene fiber and a second section of the at least two sections is comprised of a liquid permeable material.

23. A container as in claim 22, wherein the inner insert is comprised of the first section having a different composition from the second section.

24. A container as in claim 24, wherein container includes a double seal around at least a portion of the peripheral edge seal.

25. A container as in claim 24, wherein a portion of the peripheral edge seal that couples the bottom outer sheet with the top outer sheet is a peelable adhesive.

26. A container as in claim 25, wherein a heat seal is positioned inward from the peelable adhesive.

27. A container as in claim 24, wherein the peelable adhesive covers an area sufficient for opening the primary compartment.

28. A container as in claim 27, wherein a primary compartment is defined by the top outer sheet, the bottom outer sheet, and the inner insert sheet.

29. A container as in claim 28, wherein a second compartment is defined by the top outer sheet and the inner insert sheet.

30. A container as in claim 29, wherein at least one of the top outer sheet, the bottom outer sheet, and the inner insert sheet each are comprised of a material selected from a group consisting of a foil, polyethylene, high-density polyethylene, polyethylene terephthalate, a heat-pressed continuous high-density polyethylene fiber, cellophane, fluid permeable material, and combinations thereof.