Peelable PTFE sheaths and methods for manufacture of same
First Claim
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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.
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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.
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9 Claims
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1. A medical introducer device comprising:
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(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. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
(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.
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Specification