Peelable PTFE sheaths and methods for manufacture of same

• US 6,663,595 B2
• Filed: 05/21/2002
• Issued: 12/16/2003
• Est. Priority Date: 12/23/1999
• Status: Expired due to Term

• Current Assignee: Teleflex Medical Incorporated (Teleflex Incorporated)
• Original Assignee: TFX Medical, Inc.
• Inventors: Spohn, Peter Dwight, Dinsmore, Dean David
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): WILLIAMS, CATHERINE SERKE
• Application Number:
  US10/153,435
• Publication Number:
  US 20030088264A1
• Time in Patent Office: 574 Days
• Field of Search: 604/158, 604/160-161, 604/164-1-1, 604/165-1-1, 604/243, 604/264, 604/272, 264/632, 264/634, 264/638, 264/653, 264/662, 264/666, 264/514
• US Class Current: 604/161
• CPC Class Codes: A61M 25/0668 splittable, tear apart
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/06 Rod-shaped
• CPC Class Codes: B29K 2027/18 PTFE, i.e. polytetrafluorethene , e.g. ePTFE, i.e. expanded polytetrafluorethene
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: B32B 2327/18 PTFE, i.e. polytetrafluoroethylene
• CPC Class Codes: B32B 2535/00 Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B32B 27/322 comprising halogenated polyolefins, e.g. PTFE
• CPC Class Codes: B32B 7/06 permitting easy separation

Abstract

The present invention provides improved medical introducer devices which incorporate a single or multi-layer PTFE peelable sheath. Devices of the present invention are suitable for use in inserting an ancilliary medical device, e.g., a catheter, guide wire and the like, into a patient. Methods of the present invention also are disclosed which employ a precision sintering process in order to produce sheaths having excellent tear properties and optimal peelability.

Claims

1. A medical introducer device comprising:

(a) a single-layer, peelable PTFE sheath having a bore extending therethrough and that does not include mechanically produced skiving for longitudinal splitting of the sheath, the sheath thermally cured to provide a peel strength of at least about 0.5 lbs with a standard deviation of no greater than about 0.40 lbs; and

(b) a hub unit attached at a proximal end of the peelable sheath which facilitates splitting of the peelable sheath upon application of an effective shearing force thereon.

2. The device of claim 1 wherein the peel strength is at least about 0.70 lbs.

3. The device of claim 1 wherein the peel strength is at least about 1.0 lbs.

4. The device of claim 1 wherein the peel strength standard deviation is no more than about 0.30 lbs.

5. The device of claim 1 wherein the peel strength standard deviation is no more than about 0.20 lbs.

6. The device of claim 1 further comprising a plurality of wing portions attached to the hub unit on opposing sides for grasping the hub unit.

7. The device of claim 1 wherein the peelable sheath comprises a detectable material capable of external visualization.

8. The device of claim 1 further comprising a needle or dilator assembly extending longitudinally within the bore of the peelable sheath.

9. A method of introducing a catheter or guide wire into a patient comprising:

(a) providing a medical introducer device of claim 1;

(b) piercing and dilating the vasculature of the patient using the needle or dilator assembly;

(c) inserting the catheter or guidewire through the bore of the peelable sheath into vasculature of the patient;

(d) applying cooperating forces to the wing portions of the hub unit to axially shear the peelable sheath; and

(e) removing the peelable sheath from the vasculature of the patient.