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A valved introducer sheath is used to facilitate the insertion of a flexible medical device into a body. The elongated valve of the valved introducer sheath is constructed of a foam material that is injected into the sheath and sliced longitudinally to create one or more self-sealing slits through w

A valved introducer sheath is used to facilitate the insertion of a flexible medical device into a body. The elongated valve of the valved introducer sheath is constructed of a foam material that is injected into the sheath and sliced longitudinally to create one or more self-sealing slits through which flexible medical devices can be passed. As a medial device is passed through the self-sealing slit(s) at a proximal end, the self-sealing slits seal around the medical device before opening at a distal end. The elongated valve is also affixed to at least some of the inner surface of the sheath. The valve will tear into halves along at least one of the self-sealing slits when the sheath is peeled.

대표청구항 ▼

1. Apparatus for facilitating the insertion of a flexible medical device into a body, comprising:(a) a sheath comprisinga proximal hub portion,an elongated body portion extending distally from the proximal hub portion, at least some of the elongated body portion capable of being placed into the body

1. Apparatus for facilitating the insertion of a flexible medical device into a body, comprising:(a) a sheath comprisinga proximal hub portion,an elongated body portion extending distally from the proximal hub portion, at least some of the elongated body portion capable of being placed into the body,a passageway extending through the proximal hub and elongated body portions, the passageway being defined by an inner surface of the sheath, anda pair of lines extending at least some of the length, and on opposite sides, of the sheath, at least the sheath being separable along the lines; and(b) a valve comprisinga foam material filling at least some of the length of the passageway in the elongated body portion, the length of the foam material within the passageway being greater than the width of the foam material at any point within the passageway, andone or more self-sealing slits in the foam material, none of the slits extending in width to the inner surface of the sheath, the one or more slits capable of allowing the flexible medical device to pass therethrough and sealing around the device. 2. The apparatus of claim 1 wherein the foam material includes a proximal section and a distal section, the one or more slits in the distal section remaining sealed as the flexible medical device is introduced first into the one or more slits in the proximal section. 3. The apparatus of claim 2 wherein the foam material defines a depression in the proximal section. 4. The apparatus of claim 3 wherein the foam material defines the depression which comprises a conical shape for receiving the flexible medical device. 5. The apparatus of claim 1 wherein the valve is separable with the sheath. 6. The apparatus of claim 5 wherein the valve that is separable is splitable into two halves along one of the self-sealing slits. 7. The apparatus of claim 1 wherein the elongated body portion comprises at least a first section and a second section, a first cross-sectional area of the first section being greater than a second cross-sectional area of the second section. 8. The apparatus of claim 7 further comprising a shoulder disposed within the passageway and between the first and second sections. 9. The apparatus of claim 1 wherein the lines comprise scorings. 10. The apparatus of claim 1 wherein the proximal hub portion comprises a pair of wings extending substantially perpendicular to the elongated body portion of the sheath. 11. The apparatus of claim 1 wherein the foam material comprises a closed cell foam. 12. The apparatus of claim 1 wherein the foam material is affixed to a portion of an inner surface of the sheath that defines the passageway. 13. Apparatus for facilitating the insertion of a flexible medical device into a body, comprising:(a) a sheath comprisinga proximal hub portion,an elongated body portion extending distally from the proximal hub portion, at least some of the elongated body portion capable of being placed into the body,a passageway extending through the proximal hub and elongated body portions, the passageway being defined by an inner surface of the sheath, anda pair of lines extending at least some of the length, and on opposite sides, of the sheath, at least the sheath being separable along the lines; and(b) a valve comprisinga foam material filling at least some of the length of the passageway in the elongated body portion, the length of the foam material within the passageway being greater than the width of the foam material at any point within the passageway, the foam material being affixed to a portion of the inner surface of the sheath, andone or more self-sealing slits in the foam material, none of the one or more self-sealing slits in the foam material extend in width to the inner surface of the sheath, the one or more slits capable of allowing the flexible medical device to pass therethrough and sealing around the device. 14. The apparatus of claim 13 wherein the foam material includes a proximal section and a dista l section, the one or more slits in the distal section remaining sealed as the flexible medical device is introduced first into the one or more slits in the proximal section. 15. The apparatus of claim 14 wherein the foam material defines a depression in the proximal section. 16. The apparatus of claim 15 wherein the foam material defines the depression which comprises a conical shape for receiving the flexible medical device. 17. The apparatus of claim 13 wherein the valve is separable with the sheath. 18. The apparatus of claim 17 wherein the valve that is separable is splittable into two halves along one of the self-sealing slits with each of the halves of the valve remaining affixed to the respective halves of the sheath. 19. The apparatus of claim 13 wherein the lines comprise scorings. 20. The apparatus of claim 13 wherein the proximal hub portion comprises a pair of wings extending substantially perpendicular to the elongated body portion of the sheath. 21. The apparatus of claim 13 wherein the foam material comprises a closed cell foam. 22. Apparatus for facilitating the insertion of a flexible medical device into a body, comprising:(a) a sheath comprisinga proximal hub portion,an elongated body portion extending distally from the proximal hub portion,a passageway extending through the proximal hub and elongated body portions, anda pair of lines extending at least some of the length, and on opposite sides, of the sheath, at least the sheath being separable along the lines; and(b) a valve comprising:an injected foam material filling at least some of the length of the passageway in the elongated body portion, the length of the foam material within the passageway being greater than the width of the foam material at any point within the passageway, andone or more self-sealing slits in the foam material, the foam material and the one or more slits serving as a valve in the passageway of the sheath, and wherein none of the one or more self-sealing slits extends in the width to an inner surface of the sheath that defines the passageway. 23. The apparatus of claim 22 wherein the foam material defines a depression in the proximal section. 24. The apparatus of claim 23 wherein the foam material defines the depression which comprises a conical shape for receiving the flexible medical device. 25. The apparatus of claim 22 wherein the foam material includes a proximal section and a distal section, the one or more slits in the distal section remaining sealed as the flexible medical device is introduced first into the one or more slits in the proximal section. 26. The apparatus of claim 22 wherein the one or more self-sealing slits substantially prevent the flow of gas into the passageway of the sheath. 27. The apparatus of claim 22 wherein the lines comprise scorings. 28. The apparatus of claim 22 wherein the valve is separable with the sheath. 29. The apparatus of claim 22 wherein the proximal hub portion comprises a pair of wings extending substantially perpendicular to the elongated body portion of the sheath. 30. The apparatus of claim 22 wherein the foam material comprises a closed cell foam.