Barriers and methods for pressure measurement catheters
First Claim
1. A method of making a pressure measurement catheter having an improved barrier, the method comprising:
- providing a pressure measurement catheter having a proximal end, a distal end and a lumen;
providing a viscoelastic barrier material formed by at least one barrier material precursor combined with an amount of a softener; and
placing the viscoelastic barrier material in the lumen near the distal end of the catheter.
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Abstract
Methods and apparatus of the present invention provide viscoelastic barrier materials for use as barriers in devices such as pressure measurement catheters. Improved barrier materials sometimes include at least one barrier material precursor combined with an amount of a softener. In other embodiments, two barrier material precursor components are combined without a softener to provide a fully cross-linked barrier material having certain softness characteristics. In various embodiments, a softener may be dimethyl silicone oil and may be combined with a barrier material precursor in an amount of between about 25% and about 45% by weight, relative to the final barrier material. Once a viscoelastic barrier material is prepared, it may be placed in a pressure transmission catheter or similar device, for example by injecting the gel into a lumen of the catheter via a syringe. Barrier materials of the present invention have one or more advantageous properties, such as a desired softness, full cross-linking, resistance to washout from a catheter, enhanced stability and/or the like.
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Citations
47 Claims
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1. A method of making a pressure measurement catheter having an improved barrier, the method comprising:
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providing a pressure measurement catheter having a proximal end, a distal end and a lumen;
providing a viscoelastic barrier material formed by at least one barrier material precursor combined with an amount of a softener; and
placing the viscoelastic barrier material in the lumen near the distal end of the catheter. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14)
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15. A method of preparing a pressure measurement catheter, the method comprising:
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providing a catheter to a user, the catheter having a proximal end, a distal end and a lumen;
providing a viscoelastic barrier material to the user, the viscoelastic barrier material formed by at least one barrier material precursor combined with an amount of a softener; and
placing by the user the viscoelastic barrier material in the lumen near the distal end of the catheter. - View Dependent Claims (16, 17, 18, 19)
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20. A viscoelastic barrier material for use in a pressure measurement catheter, the material comprising:
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at least one barrier material precursor; and
an amount of softener combined with the at least one barrier material precursor. - View Dependent Claims (21, 22, 23, 24, 25, 26, 27, 28, 29)
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- 30. A pressure measurement catheter comprising a lumen containing a viscoelastic barrier material, the viscoelastic barrier material including at least one barrier material precursor combined with an amount of a softener.
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40. A pressure measurement catheter comprising a lumen containing a fully cross-linked viscoelastic barrier material, the barrier material comprising a first component combined with a second component in approximately a 1:
- 1 ratio by weight, wherein the barrier material has a penetration range at ten seconds of between about 21 mm and about 37 mm at a temperature of about 25°
C., wherein the penetration range is measured in a container of about 100 g of the barrier material precursor, using a penetrometer having a foot and rod, the foot having a 1-inch diameter and the foot and rod weighing about 12 g. - View Dependent Claims (41, 42)
- 1 ratio by weight, wherein the barrier material has a penetration range at ten seconds of between about 21 mm and about 37 mm at a temperature of about 25°
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43. A kit comprising:
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a pressure measurement device including a catheter having a proximal end, a distal end and a lumen;
a viscoelastic barrier material disposed within the lumen near the distal end to form a barrier, the viscoelastic barrier material comprising;
at least one barrier material precursor; and
an amount of softener combined with the at least one barrier material precursor; and
instructions for using the catheter. - View Dependent Claims (44, 45)
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46. A kit comprising:
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a syringe;
an amount of viscoelastic barrier material comprising;
at least one barrier material precursor; and
an amount of softener combined with the at least one barrier material precursor; and
instructions for using the syringe to place the viscoelastic barrier material into a lumen of a pressure measurement catheter. - View Dependent Claims (47)
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Specification