Biodegradable shroud for a dilator/sheath assembly
First Claim
Patent Images
1. An introducer assembly comprising:
- a) an elongate introducer sheath extending from a proximal portion to a distal portion, the elongate introducer sheath including a passage therethrough;
b) an elongate dilator disposed through the introducer sheath passage and having a proximal portion and a distal portion, the dilator distal portion extending out of the sheath passage, tapered to a distal dilator end; and
c) a biocompatible and biodegradable shroud covering the distal portions of the introducer sheath and of the dilator, wherein the shroud comprises;
i) a 15 wt % mannitol aqueous solution as an inner layer contacting the distal portions of the introducer sheath and of the dilator, andii) an aqueous solution containing 10 wt % of mannitol and 10 wt % of sodium chloride (NaCl) as an outer shroud layer contacting the inner shroud layer.
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Abstract
An introducer assembly includes a sheath and a dilator. A biodegradable shroud covers the distal portion of the introducer assembly on the surface of both the sheath and the dilator. The biodegradable shroud dissolves in blood after being exposed for a predetermined time. Afterwards, the dilator can be separated from the sheath without breaking the sheath. The shroud improves movement of the introducer assembly through a venous system by preventing body tissue from getting caught in the space between the dilator and the shroud, for example should a “fish mouth” separation occur between them.
26 Citations
21 Claims
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1. An introducer assembly comprising:
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a) an elongate introducer sheath extending from a proximal portion to a distal portion, the elongate introducer sheath including a passage therethrough; b) an elongate dilator disposed through the introducer sheath passage and having a proximal portion and a distal portion, the dilator distal portion extending out of the sheath passage, tapered to a distal dilator end; and c) a biocompatible and biodegradable shroud covering the distal portions of the introducer sheath and of the dilator, wherein the shroud comprises; i) a 15 wt % mannitol aqueous solution as an inner layer contacting the distal portions of the introducer sheath and of the dilator, and ii) an aqueous solution containing 10 wt % of mannitol and 10 wt % of sodium chloride (NaCl) as an outer shroud layer contacting the inner shroud layer. - View Dependent Claims (2, 3, 4, 5, 6, 7, 9, 10)
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8. An introducer assembly comprising:
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a) an elongate introducer sheath extending from a proximal portion to a distal portion, the elongate introducer sheath including a passage therethrough; b) an elongate dilator disposed through the introducer sheath passage and having a proximal portion and a distal portion, the dilator distal portion extending out of the sheath passage, tapered to a distal dilator end; and c) a biocompatible and biodegradable shroud covering the distal portions of the introducer sheath and of the dilator, wherein the shroud comprises; i) an inner layer contacting the distal portions of the introducer sheath and of the dilator, ii) an outer shroud layer contacting the inner shroud layer, and iii) wherein the outer shroud layer is relatively more lubricous than the inner shroud layer and wherein the outer shroud layer is relatively more durable than the inner shroud layer. - View Dependent Claims (20, 21)
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11. An introducer assembly comprising:
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a) an elongate introducer sheath extending from a proximal portion to a distal portion, the elongate introducer sheath including a passage therethrough; b) an elongate dilator disposed through the introducer sheath passage and having a proximal portion and a distal portion, the dilator distal portion extending out of the sheath passage, tapered to a distal dilator end; and c) a biocompatible and biodegradable shroud having a thickness of from about 0.01 mm to about 0.1 mm covering the distal portions of the introducer sheath and of the dilator, wherein the shroud comprises; i) a 15 wt % mannitol aqueous solution as an inner layer contacting the distal portions of the introducer sheath and of the dilator, and ii) an aqueous solution containing 10 wt % of mannitol and 10 wt % of sodium chloride (NaCl) as an outer layer contacting the inner layer. - View Dependent Claims (12, 13, 14)
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15. A method for providing an introducer assembly, comprising the steps of:
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a) providing an elongate introducer sheath extending from a proximal portion to a distal portion, the elongate introducer sheath including a passage therethrough; b) positioning an elongate dilator through the introducer sheath passage, the dilator having a dilator proximal portion and a dilator distal portion extending out of the sheath passage and tapered to a distal dilator end; and c) contacting the distal portions of the introducer sheath and the dilator with a biocompatible and biodegradable shroud, wherein the shroud comprises; i) a 15 wt % mannitol aqueous solution as an inner layer contacting the distal portions of the introducer sheath and of the dilator, and ii) an aqueous solution containing 10 wt % of mannitol and 10 wt % of sodium chloride (NaCl) as an outer layer contacting the inner layer. - View Dependent Claims (16, 17, 18, 19)
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Specification