Catheter assembly with resealable opening

Patent metadata

Field	Value
Publication number	US-10384033-B2
Application number	US-201414485997-A
Country	US
Kind code	B2
Filing date	Sep 15, 2014
Priority date	Dec 27, 2011
Publication date	Aug 20, 2019
Grant date	Aug 20, 2019

Abstract

A medical device assembly is disclosed, including a medical device, preferably having a hydrophilic surface coating, and a package accommodating said medical device. The package if formed of two sheets of foil material, a first foil of which has been deep drawn into a trough shape, the package further comprising a resealable opening arranged within the bounds of the second foil. The medical device may e.g. be a urinary catheter.

First claim

The invention claimed is:

1. A medical device assembly, comprising:
a catheter including an insertion end and a non-insertion end, the catheter having a hydrophilic surface coating;
a wetting fluid container including a wetting fluid, the wetting fluid container arranged separate from the catheter and close to the non-insertable end of the catheter and openable to enable release of the wetting fluid into contact with the hydrophilic surface coating of the catheter before use; and
a package accommodating the catheter and the wetting fluid container, wherein the package comprises:
a first sheet of material including a trough and a second sheet of material, the package further comprising a resealable opening arranged within the bounds of the second sheet of material, the trough forming a narrow forward part of the package having first spaced wall portions for housing and narrowly surrounding the insertion end of the catheter and a wider and deeper rearward part of the package having second spaced wall portions for housing the non-insertable end of the catheter and the wetting fluid container, the wetting fluid container being arranged overlying the non-insertable part of the catheter, wherein a depth of the trough is sufficient to entirely accommodate a height of the catheter and the wetting fluid container; and
the second sheet of material joined around an edge with an edge of the first sheet of material, wherein the resealable opening is arranged in a section of the package housing the non-insertable end of the catheter, and wherein the second sheet of material is essentially planar, wherein the second sheet further comprises a perforation line extending along a non-closed loop defining a flap opening in the second sheet and wherein an opening of the non-closed loop debouches toward an end of the package for housing the insertion end of the catheter.

2. The medical device assembly of claim 1 wherein the first and second sheets of material are joined together by welding.

3. The medical device assembly of claim 1 , wherein a third sheet completely covers the flap opening with a margin.

4. The medical device assembly of claim 1 , wherein the non-closed loop perforation line has loop ends directed towards an interior of the non-closed loop.

5. The medical device assembly of claim 1 , further comprising an additional sheet of material arranged on the first sheet, the additional sheet located on a side of the package being opposed to the resealable opening, the additional sheet being connected to the first sheet by an adhesive, the additional sheet including a first tab not provided with adhesive, the first tab providing a grip portion for exposure of the adhesive to form a holding arrangement for the package.

6. The medical device assembly of claim 1 , wherein the first and second sheets comprise laminated sheets, having a weldable inner layer and a protective outer layer.

7. The medical device assembly of claim 1 , wherein the first sheet further comprises a planar rim around a perimeter thereof.

8. The medical device assembly of claim 7 , wherein the planar rim further comprises rounded corners.

9. The medical device assembly of claim 1 , further comprising an applicator releasably attached to the non-insertable end of the catheter, arranged to be released prior to use to aid in manipulating the catheter during insertion without directly contacting the surface of the catheter.

10. The medical device assembly of claim 9 , wherein the applicator is in the form of a tube, sleeve or cuff.

11. A method of producing a medical device assembly comprising the steps:
providing a catheter including an insertion end and a non-insertion end, the catheter having a hydrophilic surface coating or being formed of a hydrophilic material;
providing a wetting fluid container containing a wetting fluid, the wetting fluid container arranged separate from the catheter and close to the non-insertable end of the catheter and being openable to enable release of the wetting fluid into contact with the hydrophilic surface coating or hydrophilic material of the catheter before use; and
accommodating the catheter and the wetting fluid container in a package, said package comprising:
first and second sheets of material connected around respective edges, the first sheet including a trough, the trough forming a narrow forward part of the package having first spaced wall portions for housing and narrowly surrounding the insertion end of the catheter and a wider and deeper rearward part of the package having second spaced wall portions for housing the non-insertable end of the catheter and the wetting fluid container, the wetting fluid container being arranged to overlay the non-insertable part of the catheter, wherein a depth of the trough is sufficient to entirely accommodate a height of the catheter and the wetting fluid container and wherein the second sheet of material is essentially planar, the package further comprising a resealable opening arranged within the bounds of the second sheet,
wherein the resealable opening is arranged in a section of the package housing the non-insertable end of the catheter, wherein the resealable opening is arranged in a section of the package housing the non-insertable end of the catheter, wherein the second sheet further comprises a perforation line extending along a non-closed loop defining a flap opening in the second sheet and wherein an opening of the non-closed loop debouches toward an end of the package for housing the insertion end of the catheter.

12. A medical device assembly, comprising:
a catheter including an insertion end and a non-insertion end, the catheter having a hydrophilic surface coating;
a wetting fluid container including a wetting fluid, the wetting fluid container arranged separate from the catheter and close to the non-insertable end of the catheter and openable to enable release of the wetting fluid into contact with the hydrophilic surface coating of the catheter before use; and
a package accommodating the catheter and the wetting fluid container, wherein the package comprises:
a first sheet of material including a trough and a second sheet of material, the package further comprising a resealable opening arranged within the bounds of the second sheet of material, the trough forming a narrow forward part of the package having first spaced wall portions for housing and narrowly surrounding the insertion end of the catheter and a wider and deeper rearward part of the package having second spaced wall portions for housing the non-insertable end of the catheter and the wetting fluid container, the wetting fluid container being arranged overlying the non-insertable part of the catheter, wherein a depth of the trough is sufficient to entirely accommodate a height of the catheter and the wetting fluid container; and
the second sheet of material joined around an edge with an edge of the first sheet of material, wherein the resealable opening is arranged in a section of the package housing the non-insertable end of the catheter, and wherein the second sheet of material is essentially planar, wherein the second sheet further comprises a perforation line extending along a non-closed loop defining a flap opening in the second sheet,
the medical device assembly further comprising a third sheet of material, the third sheet of material overlying the non-closed loop perforation line on the second sheet, the third sheet of material secured to the second sheet of material by an adhesive, the adhesive adapted to maintain a sterile closure of the package before use, and to be resealable after use, the third sheet arranged to cover the entire flap opening with a margin,

Assignees

• Dentsply Ih Ab

Inventors

• Gustavsson Evelina

Classifications

• A61M2025/0046

  Coatings for improving slidability · CPC title

• B65D75/00

  Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes or webs of flexible sheet material, e.g. in folded wrappers (bundles of articles held together by packaging elements for convenience of storage or transport, e.g. portable segregating carrier for plural receptacles such as beer cans or pop bottles, or bales of material B65D71/00) · CPC title

• A61M25/0017 Primary

  specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections · CPC title

• A61M25/002 Primary

  Packages specially adapted therefor (combined with means for introducing catheters, e.g. dispensers, A61M25/0113); catheter kit packages (for surgical articles A61B50/30) · CPC title

• B65B5/02

  Machines characterised by incorporation of means for making the containers or receptacles · CPC title