Method of shaping structures with an overcoat layer including female urinary catheter

• US 5,670,111 A
• Filed: 08/02/1994
• Issued: 09/23/1997
• Est. Priority Date: 01/10/1990
• Status: Expired due to Term

• Current Assignee: Rochester Medical Corporation (Becton, Dickinson & Co)
• Original Assignee: Rochester Medical Corporation (Becton, Dickinson & Co)
• Inventors: Conway, Anthony J., Fryar, Richard D. Jr., Conway, Philip J.
• Primary Examiner(s): Timm, Catherine
• Application Number:
  US08/285,026
• Time in Patent Office: 1,148 Days
• Field of Search: 264/512, 264/130, 264/139, 264/300, 264/305, 264/306, 264/308, 264/317, 264/254, 264/264, 264/303, 604/96, 156/289, 427/2.3, 427/270
• US Class Current: 264/512
• CPC Class Codes: A61L 2300/22 Lipids, fatty acids, e.g. prostaglandins, oils, fats, waxes
• CPC Class Codes: A61L 2300/452 Lubricants
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/0056 provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
• 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
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/0009 Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10183 Compressible bulbs
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1036 Making parts for balloon catheter systems, e.g. shafts or distal ends A61M25/1029 takes precedence
• CPC Class Codes: B29C 2791/001 Shaping in several steps
• CPC Class Codes: B29C 41/14 Dipping a core B29C41/10 takes precedence
• CPC Class Codes: B29C 41/22 Making multilayered or multicoloured articles
• CPC Class Codes: B29K 2083/00 : Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as moulding material
• CPC Class Codes: B29K 2083/005 : LSR, i.e. liquid silicone rubbers, or derivatives thereof
• CPC Class Codes: B29L 2031/7542 : Catheters
• CPC Class Codes: C08L 83/04 : Polysiloxanes

Abstract

A method of shaping polymeric structures by coating a support structure with a bond-preventing agent to attain a particular shape and subsequently coating the shaped structure of the bond-preventing agent with a polymeric bonding composition is provided. Such shaped polymeric structures can have one or more cavities which can be fluid-filled or gel-filled. Also provided is a hand-actuating retention female urinary catheter having an inner tube and an outer overcoat layer encircling the tube with an elastomeric collar with a shroud. A cavity containing a fluid is interposed between the tube and the overcoat layer. The cavity includes a balloon portion and a reservoir portion. The shroud encircles the reservoir section to inhibit the ballooning of the reservoir section when the reservoir section is squeezed to force fluid from the reservoir portion to the balloon portion through the sleeve portion of the cavity. The overcoat layer and the collar with a shroud are made of soft resilient material.

Claims

1. A method for producing a shaped article, said method comprising:

(a) providing an inner piece;

(b) forming a shaped structure on said inner piece by placing a residual coating of a bond-preventing agent on said inner piece;

(c) shaping said residual coating of said bond-preventing agent into at least a plurality of sections, each of said sections being of a different thickness, using a process comprising coating portions of an outer surface of said inner piece with a bond preventing agent in a plurality of dipping steps, wherein the inner piece is immersed into the bond-preventing agent to a desired depth for a desired length of time, and subsequently removed therefrom, wherein the desired depth and the desired length of time for each of the plurality of dipping steps is prescribed so that a residual coating of bond-preventing agent remains on portions of the inner piece following said plurality of dipping steps, said residual coating having varying thickness as a result of variation between the depth of any two of said plurality of dipping steps and the speed the bond-preventing agent is removed from the inner piece; and

(d) subsequently coating the shaped structure of said bond-preventing agent with a liquid composition to form a shaped overcoat layer, wherein the shape of the overcoat layer results from the shape of the shaped structure of said bond preventing agent.

2. The method of claim 1 wherein the shaped structure includes a first section, a second section, and a third section, said second section interconnecting and disposed between said first and third sections, said second section having a larger transverse cross-sectional area than that of said first and that of said third section.

3. The method of claim 1 further comprising replacing the bond-preventing agent with a fluid after forming the overcoat layer so as to form a fluid-filled cavity encircled by said overcoat layer.

4. The method of claim 1, wherein the step of shaping said residual coating of said bond-preventing agent includes stripping the inner piece, wherein the inner piece is immersed in a stripping fluid to a desired depth for a desired length of time following any of said plurality of dipping steps in order to remove at least a portion of the bond-preventing agent from the outer surface of the inner piece.

5. The method of claim 4 wherein the stripping fluid is removed from the inner piece at a varying speed in a dipping step effective to strip a portion of the bond-preventing agent to result in a gradually varying thickness in the coating of the bond-preventing agent on the inner piece.

6. The method of claim 1 wherein the step of subsequently coating includes dipping the inner piece and the residual coating of bond-preventing agent in the polymeric bonding composition.

7. The method of claim 1 wherein a portion of the shaped structure of a bond-preventing agent is not coated with the polymeric bonding composition to result in a polymeric structure having an inner piece integrally connected to an outer piece at one end of said inner piece, said outer piece encircling at least a portion of said inner piece to define a recess in cooperation with said inner piece at said attached end, wherein peripheral portion of the outer piece is not attached to the inner piece.

8. The method of claim 1 wherein the inner piece is made by dipping a mandrel in a liquid composition.

9. The method of claim 8 wherein the liquid composition is a polymeric bonding composition and the liquid composition for the step of subsequent coating is a polymeric bonding composition.

10. The method of claim 9 wherein the polymeric bonding compositions contain uncured silicone rubber.

11. The method of claim 1, wherein the inner piece includes a mandrel.

12. A method of shaping a structure having an overcoat layer, said method comprising:

(a) dipping a mandrel in a first liquid composition to result in a coating on the mandrel;

b) coating portions of an outer surface of said coating on the mandrel with a bond-preventing agent in a plurality of dipping steps to form a residual coating of said bond-preventing agent including at least a plurality of sections of different thicknesses; and

(c) subsequently coating the shaped residual coating of the bond-preventing agent with a second liquid composition to form a shaped overcoat layer, wherein the shape of the overcoat layer results from the shape of the shaped structure of said bond-preventing agent.

13. The method of claim 12, wherein the coating on the mandrel is immersed into the bond-preventing agent to a desired depth for a desired length of time, and subsequently removed therefrom, wherein the desired depth and the desired length of time for each of the plurality of dipping steps is prescribed so that a residual coating of bond-preventing agent remains on portions of the inner piece following said plurality of dipping steps, said residual coating having said section of different thickness as a result of variation between the depth of any two of said plurality of dipping steps and the speed the bond-preventing agent is removed from the inner piece.

14. The method of claim 12, wherein the first liquid composition is a polymeric bonding composition.

15. The method of claim 14, wherein the second liquid composition contains uncured silicone rubber.

16. The method of claim 12, wherein the second liquid composition is a polymeric bonding composition.

17. The method of claim 12, wherein the structure having an overcoat layer has multiple cavities encircled by the overcoat layer.

18. A method of shaping a structure having an overcoat layer on an inner structure with a lumen, said method comprising:

(a) dipping a mandrel in a first polymeric bonding composition to result in a coating on the mandrel;

(b) coating portions of an outer surface of said coating on the mandrel with a bond-preventing agent in a plurality of dipping steps to form a residual coating of a desired shape by immersing the coating on the mandrel into the bond-preventing agent to a desired depth for a desired length of time, wherein the desired depth and the desired length of time for each of the plurality of dipping steps is prescribed so that a residual coating of the bond-preventing agent remains on portions of the coating on the mandrel following said plurality of dipping steps, said residual coating having a varying thickness as a result of variation between the depth of any two of said plurality of dipping steps and the speed the bond-preventing agent is removed from the coating on the mandrel;

(c) subsequently coating at least a portion of the shaped residual coating of the bond-preventing agent with a second polymeric bonding composition to form a shaped overcoat layer, wherein the shape of the overcoat layer results from the shape of the shaped structure of the bond-preventing agent; and

(d) subsequently replacing the bond-preventing agent coated by the second polymeric bonding composition with a fluid.

19. The method of claim 18, wherein the fluid is mineral oil.