Vapor Hydrated Catheter Assembly and Method of Making Same

• US 20090131917A1
• Filed: 04/10/2008
• Published: 05/21/2009
• Est. Priority Date: 11/19/2007
• Status: Active Grant

• Current Assignee: Hollister Incorporated
• Original Assignee: Hollister Incorporated
• Inventors: Passalaqua, James J., Udayakumar, Bettakeri S., Gilman, Thomas H., Jorgensen, Kai, Kavanagh, Seamus T.
• Granted Patent: US 8,523,843 B2
• Time in Patent Office: Days
• US Class Current: 604/544
• CPC Class Codes: A61M 2025/0062 having features to improve the sliding of one part within another by using lubricants or surfaces with low friction coatings A61M2025/0046
• 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: A61M 25/0111 Aseptic insertion devices

Abstract

A catheter assembly and method is disclosed which comprises a catheter having a coating on at least a part of its length intended to produce a low-friction surface on the catheter when treated with an activating substance in the form of a vapor. The catheter assembly also includes a catheter package forming an interior space divided by a gas permeable, liquid impermeable barrier into a first cavity and a second cavity. The first cavity of the catheter package accommodates the catheter therein and the second cavity accommodates at least a quantity of liquid in its liquid phase therein. The liquid in the second cavity can change phase into a vapor capable of passing from the second cavity, through the barrier, and into the first cavity where the vapor can activate the coating. As a result, the vapor produced when the liquid changes phase causes the coating on the catheter to be activated to thereby produce the low-friction surface on the catheter so it is ready-to-use when it reaches the end user.

Claims

1. A catheter assembly comprising a catheter having a coating on at least a part of its length intended to produce a low-friction surface on the catheter when treated with an activating substance, a catheter package forming an interior space divided by a gas permeable, liquid impermeable barrier into a first cavity and a second cavity, the first cavity accommodating at least the part of the catheter having the coating thereon and the second cavity accommodating at least a quantity of liquid, the liquid in the second cavity being adapted so at least some of the liquid can change phase into vapor capable of passing from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity, the vapor serving as the activating substance for the coating to thereby produce the low-friction surface on the catheter.

2. The catheter assembly of claim 1 wherein the catheter package forming the interior space is made of a gas impermeable material comprised of two confronting sheets having the catheter and the liquid therebetween and joined by a seal extending substantially entirely about the perimeters of the sheets.

3. The catheter assembly of claim 1 wherein the catheter package forming the interior space is made of a gas impermeable material comprised of a single sheet encapsulating the catheter and the liquid with opposite edges joined by a longitudinal seal and having an end seal at each of opposite ends thereof.

4. The catheter assembly of claim 1 including a wicking material within the second cavity to be wetted with the liquid so at least some of the liquid can change phase into vapor after the wicking material has been wetted.

5. The catheter assembly of claim 1 including a wicking material within the second cavity in liquid flow communication with a rupturable container for the liquid to absorb the liquid when the container has been breached.

6. The catheter assembly of claim 5 wherein the rupturable container is a self-contained rupturable container in the catheter package for liquid flow communication with the wicking material within the second cavity.

7. The catheter assembly of claim 5 wherein the rupturable container is a rupturable compartment in the catheter package with a rupturable seal for liquid flow communication with the wicking material within the second cavity.

8. The catheter assembly of claim 1 wherein the catheter package includes a rupturable container for the liquid which is in liquid flow communication with the second cavity thereof, the catheter package also including a wicking material disposed within the second cavity so as to extend longitudinally generally coextensive with the catheter in the first cavity and having an end thereof positioned in proximity to the rupturable container, and a seal extending inwardly from each side of the catheter package between the catheter and the rupturable container to form a passageway for the liquid to pass through to the end of the wicking material.

9. The catheter assembly of claim 1 wherein the catheter package includes a rupturable compartment for the liquid which is in liquid flow communication with the second cavity, the catheter package also including a wicking material disposed within the second cavity so as to extend longitudinally generally coextensive with the catheter in the first cavity and having an end thereof positioned in proximity to the rupturable compartment, and a rupturable seal associated with the rupturable compartment and an intermediate seal extending across the wicking material in spaced relation to the rupturable seal to form an intermediate compartment.

10. The catheter assembly of claim 1 including a sleeve at least substantially covering the part of the catheter having the coating.

11. The catheter assembly of claim 10 wherein the sleeve is attached to an insertion tip operatively associated with the catheter.

12. The catheter assembly of claim 10 wherein the sleeve is attached substantially at or near a funnel end of the catheter.

13. The catheter assembly of claim 11 wherein the sleeve is attached substantially at or near a funnel end of the catheter.

15. The catheter assembly of claim 13 wherein the wicking material is disposed within the second cavity generally coextensive with the catheter and the package includes a seal extending inwardly from each side thereof between the catheter and the rupturable container to form a passageway for the liquid to pass through to the end of the wicking material.

14. A catheter assembly comprising a catheter having a hydrophilic coating on at least a part of its length intended to produce a low-friction surface on the catheter when treated with a hydrating substance, a catheter package formed of a gas impermeable material to have an interior space divided by a gas permeable, liquid impermeable barrier into first and second cavities, the first cavity accommodating the catheter and the second cavity accommodating a wicking material and a quantity of liquid, the wicking material being disposed within the second cavity for liquid flow communication with a rupturable container for the liquid to absorb the liquid when the container has been breached, the liquid absorbed by the wicking material being capable of changing phase into vapor capable of passing from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity, the vapor passing into the first cavity serving as the hydrating substance for treatment of the hydrophilic coating to produce the low-friction surface on the catheter.

16. The catheter assembly of claim 14 wherein the catheter package is formed to be of a generally elongated rectangular shape and the catheter and at least a major portion of the wicking material are disposed to extend at least substantially between the inwardly extending seal and an end of the catheter package located opposite the rupturable container.

18. The catheter assembly of claim 16 wherein the wicking material is disposed within the second cavity to extend generally coextensive with the catheter and the rupturable seal defines a boundary of the rupturable compartment, the catheter package including an intermediate seal disposed in spaced relation to the rupturable seal to define an intermediate compartment with the intermediate seal extending across the wicking material.

19. The catheter assembly of claim 16 wherein the catheter package is formed to have an intermediate compartment between the first and second cavities, on the one hand, and the rupturable compartment, on the other hand, the intermediate compartment extending between the wicking material and the rupturable compartment to define a space for receiving liquid from the rupturable compartment after the rupturable seal has been breached.

17. A catheter assembly comprising a catheter having a hydrophilic coating on at least a part of its length intended to produce a low-friction surface on the catheter when treated with a hydrating substance, a catheter package formed of a gas impermeable material to have an interior space divided by a gas permeable, liquid impermeable barrier into first and second cavities, the first cavity accommodating the catheter and the second cavity accommodating a wicking material and a quantity of liquid, the wicking material being disposed within the second cavity for liquid flow communication with a rupturable compartment for the liquid to absorb the liquid when a rupturable seal has been breached, the liquid absorbed by the wicking material being capable of changing phase into vapor capable of passing from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity, the vapor passing into the first cavity serving as the hydrating substance for treatment of the hydrophilic coating to produce the low-friction surface on the catheter.

20. The catheter assembly of claim 17 wherein the wicking material has an end portion which extends from the second cavity through the intermediate seal into the intermediate compartment for wicking the liquid from the intermediate compartment into the second cavity.

22. The catheter assembly of claim 20 wherein the tear tape extends within the first sealed cavity in a desired direction relative to the catheter to cause the package to open along the intended opening line in a manner facilitating removal of the catheter from the first sealed cavity for use without opening the second sealed cavity.

21. A catheter assembly comprising a catheter having a hydrophilic coating on at least a part of its length intended to produce a low-friction surface on the catheter when treated with a hydrating substance, a sealed catheter package forming a sealed interior space divided by a gas permeable, liquid impermeable barrier into a first sealed cavity and a second sealed cavity, the first sealed cavity accommodating the catheter and the second sealed cavity accommodating at least a quantity of liquid, the liquid being capable of changing phase into vapor capable of passing from the second sealed cavity, through the gas permeable, liquid impermeable barrier, and into the first sealed cavity, the vapor serving as the hydrating substance for the hydrophilic coating to thereby produce the low-friction surface on the catheter, and a tear tape affixed to the first sealed cavity of the catheter package to cause the catheter package to tear along the tear tape to thereby cause the catheter package to open along an intended opening line for access to the catheter in the first sealed cavity without opening the second sealed cavity.

23. The catheter assembly of claim 21 wherein the tear tape is adhesively affixed to an inner surface of the catheter package within the first sealed cavity and extends generally from one end of the catheter package to the other end of the catheter package in generally parallel relation to the catheter in the first sealed cavity.

24. A catheter assembly comprising a catheter having a hydrophilic coating on at least a part of its length intended to produce a low-friction surface on the catheter when treated with a hydrating substance, a catheter package forming an interior space divided by a gas permeable, liquid impermeable barrier into a first cavity and a second cavity, the first cavity accommodating at least the part of the catheter having the coating and the second cavity accommodating at least a quantity of liquid, at least some of the liquid in the second cavity being adapted to change phase into vapor capable of passing from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity where the vapor can serve as the hydrating substance for the hydrophilic coating to thereby produce the low-friction surface on the catheter.

26. The method of claim 24 wherein the catheter package forming the interior space is made of a gas impermeable material comprised of two confronting sheets of material having the catheter and the liquid therebetween wherein the interior space is defined by a seal joining the two sheets of material substantially entirely about the perimeters thereof.

27. The method of claim 24 wherein the catheter package forming the interior space is made of a gas impermeable material comprised of a single sheet of material encapsulating the catheter and the liquid therein wherein the interior space is defined by a single longitudinal seal and an end seal at each of opposite ends of the single sheet of material.

28. The method of claim 24 further including the steps of providing the liquid in a rupturable container in liquid communication with the second cavity, providing a wicking material in the second cavity, and breaching the rupturable container after sealing the catheter package for releasing the liquid for absorption by the wicking material.

29. The method of claim 27 including the step of sterilizing the catheter and the liquid after the catheter package has been sealed but before the rupturable container has been breached.

30. The method of claim 24 further including the steps of providing the liquid in a rupturable compartment in liquid communication with the second cavity, providing a wicking material in the second cavity, and breaching the rupturable compartment after sealing the catheter package for releasing the liquid for absorption by the wicking material.

31. The method of claim 27 including the steps of placing the wicking material in the second cavity to extend longitudinally generally coextensive with the catheter in the first cavity with an end thereof positioned in proximity to the rupturable container, and providing a seal extending inwardly from each side of the catheter package between the catheter and the rupturable container to form a passageway for the liquid to pass through to the end of the wicking material.

32. The method of claim 24 including the steps of placing the wicking material in the second cavity to extend longitudinally generally coextensive with the catheter in the first cavity, providing the liquid within the catheter package in a rupturable compartment having a rupturable seal for liquid flow communication with the wicking material in the second cavity, and breaching the rupturable seal to release the liquid from the rupturable compartment to be absorbed by the wicking material.

33. The method of claim 31 wherein the wicking material is positioned in the second cavity for liquid flow communication with the rupturable compartment after the rupturable seal is breached, the wicking material having an end positioned in proximity to the rupturable compartment, and forming an intermediate seal across the catheter package generally between the rupturable seal and the catheter to extend across the wicking material to form an intermediate compartment.

35. The method of claim 33 including the step of sterilizing the catheter and the liquid after the catheter package has been sealed but before any vapor formed by the liquid changing phase has been able to substantially hydrate the hydrophilic coating on the catheter.

36. The method of claim 33 wherein the liquid is contained in a rupturable container within the catheter package which can be breached after sealing the catheter package to permit the liquid to be absorbed by the wicking material to be available to change phase into vapor.

37. The method of claim 33 wherein the wicking material is wetted with the liquid after the wicking material has been placed in the second cavity.

38. The method of claim 33 including the step of placing the wicking material in the second cavity to extend longitudinally generally coextensive with the catheter in the first cavity with an end thereof positioned in proximity to the rupturable container, and providing a seal extending inwardly from each side of the catheter package between the catheter and the rupturable container to form a passageway for the liquid to pass through to the end of the wicking material.

39. The method of claim 37 further including the steps of forming the catheter package to have a generally elongated rectangular shape, placing at least a major portion of the wicking material between the inwardly extending seal and the end of the package opposite the rupturable container, severing the catheter package between the catheter and the rupturable container following absorption of the liquid by the wicking material, and forming an end seal for the catheter package.

41. The method of claim 39 including the step of sterilizing the catheter and the liquid after the catheter package has been sealed but before the rupturable seal has been breached.

42. The method of claim 39 including the step of forming the catheter package to have a generally elongated rectangular shape and placing at least a major portion of the wicking material within the second cavity, and forming an intermediate seal to extend across an end of the wicking material in spaced relation to the rupturable seal to form an intermediate compartment.

43. The method of claim 39 including the step of forming the catheter package to have an intermediate compartment between the first and second cavities, on the one hand, and the rupturable compartment, on the other hand, the intermediate compartment extending between the wicking material and the rupturable seal to receive the liquid after the rupturable seal is breached.

44. The method of claim 42 wherein an end of the wicking material extends through the intermediate seal into the intermediate compartment to wick the liquid into the second cavity, and including the step of severing the catheter package through the intermediate compartment after the liquid has been wicked into the second cavity and forming an end seal for the catheter package.

46. The method of claim 44 wherein the tear tape extends within the first cavity in a desired direction relative to the catheter to cause the catheter package to open along the intended opening line for removal of the catheter from the first cavity without opening the second cavity.

47. The method of claim 44 wherein the tear tape is adhesively affixed to an inner surface of the catheter package within the first cavity and extends generally from one end of the catheter package to the other end of the catheter package generally parallel to the catheter.

25. A method of making a ready-to-use catheter assembly, comprising the steps of providing a catheter package having an interior space divided by a gas permeable, liquid impermeable barrier into a first cavity and a second cavity, placing a catheter having a hydrophilic coating on at least a part of its length into the catheter package and placing a quantity of liquid into the catheter package, the liquid being placed into the catheter package in isolation relative to the first cavity and adapted for confinement within the second cavity, sealing the catheter package with at least the part of the catheter having the coating within the first cavity and the liquid within the second cavity, and delaying use of the catheter assembly for a period of time sufficient for i) the liquid to be placed for confinement within the second cavity, ii) at least some of the liquid to change phase into vapor within the second cavity, iii) at least some of the vapor to pass from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity, and iv) the vapor in the first cavity to hydrate the hydrophilic coating to produce a low-friction surface on the catheter, whereby the catheter assembly is ready-to-use.

34. A method of making a ready-to-use catheter assembly, comprising the steps of providing a catheter package having an interior space divided by a gas permeable, liquid impermeable barrier into a first cavity and a second cavity, placing a catheter having a hydrophilic coating on at least a part of its length, a wicking material, and a quantity of liquid into the catheter package, sealing the catheter package with at least the part of the catheter having the coating within the first cavity, the wicking material in the second cavity, and the liquid within the catheter package in a manner making it possible for the liquid to be absorbed by the wicking material, and delaying distribution of the catheter assembly for a period of time sufficient for i) the liquid to be absorbed by the wicking material, ii) at least some of the liquid to change phase into vapor in the second cavity, iii) at least some of the vapor to pass from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity, and iv) the vapor in the first cavity to hydrate the hydrophilic coating to produce a low-friction surface on the catheter, whereby the catheter assembly is ready-to-use.

40. A method of making a ready-to-use catheter assembly, comprising the steps of providing a catheter package having an interior space divided by a gas permeable, liquid impermeable barrier into a first cavity and a second cavity, placing a catheter having a hydrophilic coating on at least a part of its length, a wicking material, and a quantity of liquid into the catheter package, the quantity of liquid being disposed within a rupturable compartment formed in the catheter package by a rupturable seal for liquid flow communication with the second cavity, sealing the catheter package with at least the part of the catheter having the coating in the first cavity, the wicking material in the second cavity, and the liquid in the rupturable compartment, breaching the rupturable seal after sealing the catheter package to release the liquid for absorption by the wicking material, and delaying distribution of the catheter assembly for a period of time sufficient for i) the liquid to be absorbed by the wicking material, ii) at least some of the liquid to change phase into vapor in the second cavity, iii) at least some of the vapor to pass from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity, and iv) the vapor in the first cavity to hydrate the hydrophilic coating to produce a low-friction surface on the catheter, whereby the catheter assembly is ready-to-use.

45. A method of making and using a ready-to-use catheter assembly, comprising the steps of providing a catheter package having an interior space divided by a gas permeable, liquid impermeable barrier into a first cavity and a second cavity, providing a catheter having a hydrophilic coating on at least a part of its length intended to produce a low-friction surface on the catheter when treated with a hydrating substance, placing at least the part of the catheter having a hydrophilic coating into the first cavity, placing a quantity of liquid into the catheter package for confinement in the second cavity, providing the catheter package with a tear tape affixed to the first cavity, sealing the catheter package to thereby form the interior space, delaying distribution of the catheter assembly for a period of time sufficient for i) the liquid to be placed for sealed confinement within the second cavity, ii) at least some of the liquid to change phase into vapor within the second cavity, iii) at least some of the vapor to pass from the second cavity, through the gas permeable, liquid impermeable barrier, and into the first cavity, and iv) the vapor in the first cavity to hydrate the hydrophilic coating to produce a low-friction surface on the catheter, whereby the catheter assembly is ready-to-use, and thereafter using the tear tape to open the first cavity of the catheter package along an intended opening line for access to the catheter in the first cavity without opening the second cavity.