FLEXIBLE MEDICAL ARTICLE AND METHOD OF MAKING THE SAME

• US 20150038944A1
• Filed: 03/13/2013
• Published: 02/05/2015
• Est. Priority Date: 03/14/2012
• Status: Active Grant

• Current Assignee: Smiths Medical ASD, Inc. (Smiths Group International Holdings Ltd.)
• Original Assignee: Access Scientific, LLC
• Inventors: Bierman, Steven F.
• Granted Patent: US 9,981,113 B2
• Time in Patent Office: Days
• US Class Current: 604/510
• CPC Class Codes: A61M 25/0606 "Over-the-needle" catheter assemblies, e.g. I.V. catheters
• CPC Class Codes: B29C 2071/022 Annealing
• CPC Class Codes: B29C 2791/002 Making articles of definite length, i.e. discrete articles B29C53/40 takes precedence
• CPC Class Codes: B29C 48/0022 combined with cutting
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/10 flexible, e.g. blown foils
• CPC Class Codes: B29C 48/91 Heating, e.g. for cross linking
• CPC Class Codes: B29C 48/9105 of hollow articles
• CPC Class Codes: B29C 48/92 Measuring, controlling or regulating
• CPC Class Codes: B29C 57/02 Belling or enlarging, e.g. combined with forming a groove
• CPC Class Codes: B29C 71/02 Thermal after-treatment B29C71/0063 and B29C71/0072 take precedence
• CPC Class Codes: B29D 23/001 Pipes; Pipe joints pleated hoses B29D23/18
• CPC Class Codes: B29K 2069/00 Use of PC, i.e. polycarbonates or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29L 2023/00 Tubular articles B29L2024/00 takes precedence ; catheters B29L2031/7542
• CPC Class Codes: B29L 2023/007 Medical tubes other than catheters catheters B29L2031/7542
• CPC Class Codes: B29L 2023/20 Flexible squeeze tubes, e.g. for cosmetics
• CPC Class Codes: B29L 2031/7542 Catheters

Abstract

A method of making a flexible medical article or tube, for example, a sheath for a vascular access device, is provided. The method can include extruding a polymer, for example, a polycarbonate-urethane copolymer, to form a tube and annealing the extruded polymer. The method can further include cutting the extruded tube to a desired length before or after annealing, flaring one end of the annealed tube and over-molding the flared portion onto a hub, and forming the other end of the tube into a tip. A sheath formed by such a method is also provided.

Claims

1. A method for forming at least a portion of a flexible medical article, the method comprising:

extruding a polymer to form said portion of the medical article; and

annealing said portion of the medical article.

2. The method of claim 1, wherein annealing comprises annealing said portion of the medical article at about 248°

F. for about one hour.

3. The method of claim 1, wherein the polymer comprises urethane.

4. The method of claim 1, wherein the polymer is selected have the property of reduced rigidity when exposed to heat.

5. The method of claim 4, wherein the polymer comprises urethane polycarbonate.

6. The method of claim 1, further comprising cutting said portion of the medical article.

7. The method of claim 1, further comprising flaring an end of said portion of the medical article so that the end is configured to be coupled to a hub of the medical article.

8. The method of claim 7, further comprising over-molding the end of the portion of the medical article onto the hub.

9. The method of claim 1, further comprising forming an end of the portion of the medical article into a tip.

10. A medical article having a flexible, tubular shaft with at least one lumen, the shaft being formed by a process comprising:

extruding a polymer to form at least the tubular shaft of the medical article; and

annealing the tubular shaft.

11. The medical article of claim 10, wherein annealing comprises annealing the tubular shaft of the medical article at about 248°

F. for about one hour.

12. The medical article of claim 10, wherein the tubular shaft is annealed sufficiently so as to be capable of bending up to about 120°

without kinking.

13. The medical article of claim 10, wherein the polymer comprises a polycarbonate-urethane copolymer.

14. The medical article of claim 10, wherein the polymer is capable of withstanding pressures up to 300 psi.

15. The medical article of claim 10, wherein the polymer is capable of withstanding flow rates of up to 130 ml/min.

16. The medical article of claim 10, wherein the polymer has increased flexibility upon exposure to heat.

17. The medical article of claim 10 additionally comprising a hub from which the shaft extends.

18. The medical article of claim 17 additionally comprising a needle having a needle shaft and a needle hub, a dilator having a dilator shaft and a dilator hub, and a guidewire, wherein the dilator shaft is coaxially disposed on the needle shaft with the needle hub and dilator hub juxtaposed, the guidewire is at least partially disposed in the needle, and the shaft is coaxially disposed on the dilator shaft with the hub juxtaposed the dilator hub.

19. The medical article of claim 17 additionally comprising a track along which the needle hub travels, the track being attached to the dilator hub.

20. A method of using a medical article having a flexible shaft comprising annealed urethane polycarbonate, the method comprising inserting the shaft into a vessel over a guidewire, withdrawing the guidewire, and bending the shaft to lie substantially parallel to the skin, and retaining the shaft in the bent position without kinking the shaft.