초록 ▼

A method and apparatus for closing a vascular wound includes a guidewire and/or other surgical implement extending from the wound. A hemostatic material is advanced over the surgical implement and into contact with an area of the blood vessel surrounding the wound. The surgical implement is removed.

A method and apparatus for closing a vascular wound includes a guidewire and/or other surgical implement extending from the wound. A hemostatic material is advanced over the surgical implement and into contact with an area of the blood vessel surrounding the wound. The surgical implement is removed. Blood soaks the hemostatic material, and blood clotting is facilitated by the hemostatic agent within the material. A sealing layer of adhesive can be applied to the hemostatic material, confining the blood flow to the material. The vascular puncture wound is sealed by natural blood clot formation.

대표청구항 ▼

1. An assembly for locating and closing a vascular puncture, comprising: an elongate, unitary catheter having a lumen sized and adapted to accommodate a guidewire threaded therethrough, the catheter comprising a distal tip having a first outer diameter and a non-inflatable puncture edge engagement p

1. An assembly for locating and closing a vascular puncture, comprising: an elongate, unitary catheter having a lumen sized and adapted to accommodate a guidewire threaded therethrough, the catheter comprising a distal tip having a first outer diameter and a non-inflatable puncture edge engagement portion proximal of the distal tip and having a second outer diameter greater than the first diameter, the catheter being generally tapered from the distal tip to the engagement portion, the catheter configured to slide over the guidewire so that a portion of the catheter extends through the vascular puncture and the engagement portion engages edges of the puncture and urges such edges radially outwardly, the engagement portion sized to flex the puncture edges radially outwardly sufficient to substantially plug the puncture;a hemostatic sponge positioned on the catheter entirely proximal of the engagement portion and arranged so as to extend substantially circumferentially around an outer surface of the catheter;a retractor selectively movable between a closed position and an open position, the retractor configured so that when in the closed position portions of the retractor on opposing sides of the catheter engage the outer surface of the catheter sufficient so that the catheter and retractor move together when the retractor is closed upon the catheter, the retractor additionally configured when in the closed position to prevent distal movement of the sponge longitudinally over the catheter and past the retractor, the retractor further configured when in the open position to enable the sponge to move longitudinally over the catheter and through the open retractor; anda push member configured to engage the hemostatic sponge and push the sponge distally over the catheter when the retractor is in the open position. 2. The assembly of claim 1, wherein the retractor has a plurality of elongate retractor arms, the retractor arms being movable between a closed position and an open position. 3. The assembly of claim 2, wherein the retractor is configured so that, when the retractor arms are in the opened position, an access passage is defined between the arms, the access passage sized so that the hemostatic sponge and the push member can slide therethrough. 4. The assembly of claim 1, wherein the hemostatic sponge and the push member are mounted onto the catheter so as to slide longitudinally over the catheter, and the hemostatic sponge is mounted distally of the push member. 5. The assembly of claim 4, wherein the sponge is mounted onto the catheter at a position that is proximal of the retractor arms. 6. The assembly of claim 4, wherein the sponge comprises an absorbent material adapted to soak up blood. 7. The assembly of claim 6, wherein the sponge is adapted to aid blood clotting. 8. The assembly of claim 4, wherein the hemostatic sponge is generally cohesive so that when the push member engages and pushes on only a portion of one side of the sponge, the entire sponge moves distally over the catheter as a cohesive unit. 9. The assembly of claim 8 additionally comprising an elongate release rod having a distal end disposed proximal of the sponge, wherein the push member comprises an elongate lumen, and the rod is configured to slidably fit through the push member lumen into engagement with the sponge. 10. The assembly of claim 1, wherein the push member comprises an elongate body and a proximal handle portion, and a longitudinal lumen is formed through the push member. 11. The assembly of claim 10 additionally comprising an elongate release rod having a distal end disposed proximal of the sponge, the rod configured to slidably fit through the push member lumen and into engagement with the sponge. 12. The assembly of claim 10, wherein the push member body has a plurality of holes formed through a side wall thereof near a distal end of the body. 13. The assembly of claim 12, wherein the push member lumen is adapted to be attached to a source of flowable adhesive. 14. The assembly of claim 1, wherein the hemostatic sponge comprises a first layer attached to a second layer, the first layer having greater elasticity than the second layer. 15. The assembly of claim 14, wherein the first and second layers are attached to each other by a cement. 16. The assembly of claim 14, wherein the first and second layers are integrally formed. 17. The assembly of claim 14, wherein the hemostatic sponge is configured so that a puncture hole through the first and second layers is substantially sealingly closed by the elastic first layer. 18. The assembly of claim 17, wherein the catheter extends through a puncture hole formed through the first and second layers. 19. The assembly of claim 1, wherein the sponge is coated with an adhesive. 20. The assembly of claim 1, wherein the sponge comprises an anti-inflammatory drug. 21. The assembly of claim 1, wherein the sponge comprise an antibiotic. 22. The assembly of claim 1, wherein the push member comprises a lumen adapted to communicate a flowable adhesive therethrough. 23. The assembly of claim 1, wherein the catheter is attachable to a source of suction, and a hole is formed through a wall of the catheter near a distal end of the lumen. 24. The assembly of claim 1, wherein the push member is sized and configured to urge the sponge over the catheter from a position proximal of the retractor to a distal end of the retractor. 25. The assembly of claim 1, wherein the sponge is not compressed within a housing. 26. An assembly for locating and closing a vascular puncture, comprising: an elongate catheter having a lumen sized and adapted to accommodate a guidewire threaded therethrough, the catheter comprising a distal tip having a first outer diameter and a puncture edge engagement portion proximal of the distal tip and having a second outer diameter greater than the first diameter, the catheter configured to slide over the guidewire so that a portion of the catheter extends through the vascular puncture and the engagement portion engages edges of the puncture, the engagement portion sized to flex the puncture edges sufficient to plug the puncture;a hemostatic sponge positioned on the catheter proximal of the engagement portion and arranged so as to extend substantially circumferentially around an outer surface of the catheter;a retractor selectively movable between a closed position and an open position, the retractor configured to engage the outer surface of the catheter when in the closed position and configured when in the open position to enable the sponge to move longitudinally over the catheter and through the open retractor;a push member configured to engage the hemostatic sponge and push the sponge distally over the catheter; andmeans for engaging body tissues proximal of the sponge so as to prevent the sponge from moving in a direction away from the vascular puncture once the sponge is installed on an outer surface of a vascular vessel at or adjacent the puncture, wherein the means comprises swept-back arms, and wherein the means is formed separately from the sponge, more rigid than the sponge, and is held in place by the tissues directly proximal of the sponge and the means. 27. An assembly for locating and closing a vascular puncture, comprising: an elongate catheter having a lumen sized and adapted to accommodate a guidewire threaded therethrough, the catheter comprising a distal tip having a first outer diameter and a puncture edge engagement portion proximal of the distal tip and having a second outer diameter greater than the first diameter, the catheter configured to slide over the guidewire so that a portion of the catheter extends through the vascular puncture and the engagement portion engages edges of the puncture, the engagement portion sized to urge the edges radially outwardly so as to flex the puncture edges sufficient to substantially plug the puncture;a hemostatic sponge positioned on the catheter proximal of the engagement portion and arranged so as to extend substantially circumferentially around an outer surface of the catheter;a retractor selectively movable between a closed position and an open position, the retractor configured to engage and mount upon the outer surface of the catheter when in the closed position sufficient so that the catheter and retractor move together as a unit, and so as to prevent distal movement of the sponge past the retractor, and configured when in the open position to enable the sponge to move longitudinally over the catheter and through the open retractor;a push member configured to engage the hemostatic sponge and push the sponge distally over the catheter, the push member comprising an elongate body and a proximal handle portion, and a longitudinal lumen is formed through the push member; andan elongate release rod having a distal end disposed generally proximal the sponge, the rod configured to slidably fit through the push member lumen so that its distal end engages the sponge. 28. The assembly of claim 27, wherein the retractor has a plurality of elongate retractor arms, the retractor arms being movable between a closed position and an open position. 29. The assembly of claim 28, wherein the retractor is configured so that, when the retractor arms are in the opened position, an access passage is defined between the arms, the access passage sized so that the hemostatic sponge and the push member can slide therethrough. 30. The assembly of claim 28, wherein the hemostatic sponge and the push member are mounted onto the catheter so as to slide longitudinally over the catheter, and the hemostatic sponge is mounted distally of the push member. 31. The assembly of claim 30, wherein the sponge is mounted proximal of the retractor arms. 32. The assembly of claim 28, wherein the hemostatic sponge is generally cohesive so that when the push member engages and applies a force to only a portion of one side of the sponge, the entire sponge moves distally over the catheter as a cohesive unit. 33. The assembly of claim 27, wherein the hemostatic sponge comprises a first layer attached to a second layer, the first layer having greater elasticity that the second layer. 34. An assembly for locating and closing a vascular puncture, comprising: an elongate catheter having a lumen sized and adapted to accommodate a guidewire threaded therethrough, the catheter comprising a distal tip having a first outer diameter and a puncture edge engagement portion proximal of the distal tip and having a second outer diameter greater than the first diameter, the catheter configured to slide over the guidewire so that a portion of the catheter extends through the vascular puncture and the engagement portion engages edges of the puncture, the engagement portion sized to urge the edges radially outwardly so as to flex the puncture edges sufficient to substantially plug the puncture;a hemostatic sponge positioned on the catheter proximal of the engagement portion and arranged so as to extend substantially circumferentially around an outer surface of the catheter;a retractor selectively movable between a closed position and an open position, the retractor configured to engage the outer surface of the catheter when in the closed position sufficient so that the retractor and catheter move together as a single assembly when the catheter is closed upon the catheter, and configured when in the open position to be unattached to the catheter and defining a space sufficient to enable the sponge to move longitudinally over the catheter and through the open retractor; anda push member configured to releasably engage the hemostatic sponge and push the sponge distally over the catheter, the push member comprising an elongate body, a proximal handle portion, and a longitudinal lumen formed therethrough, the push member positioned so as to releasably engage the sponge with a distal end of the push member body;wherein the push member body has a plurality of holes formed through a side wall thereof near but proximal of the distal end of the body;wherein the hemostatic sponge is generally cohesive so that when the push member body distal end engages and applies a force to only a portion of one side of the sponge, the entire sponge moves distally over the catheter as a cohesive unit, and at least a portion of the sponge remains distal of the push member body distal end; andwherein the holes formed through the side wall of the push member body are arranged so as to be proximal of the hemostatic sponge when the push member body distal end engages and applies a force to the hemostatic sponge. 35. The assembly of claim 34, wherein the push member lumen is adapted to be attached to a source of flowable adhesive. 36. The assembly of claim 35, wherein the hemostatic sponge comprises a first layer attached to a second layer, the first layer having greater elasticity that the second layer. 37. The assembly of claim 34, wherein the hemostatic sponge and the push member are mounted onto the catheter so as to slide longitudinally over the catheter, and the sponge is mounted proximal of the retractor arms. 38. The assembly of claim 37 additionally comprising an elongate release rod having a distal end disposed generally proximal of the sponge, the rod configured to slidably fit through the push member lumen into engagement with the sponge. 39. An assembly for locating and closing a vascular puncture, comprising: an elongate catheter having a lumen sized and adapted to accommodate a guidewire threaded therethrough, the catheter configured to slide over a guidewire so that a portion of the catheter extends through the vascular puncture and engages edges of the puncture;a retractor selectively movable between a closed position and an open position, the retractor sized and configured to engage at least a portion of an outer surface of the catheter on opposing sides when in the closed position so that there is no space between the retractor and the catheter, and configured to provide a space between the catheter and the retractor when in the open position;a hemostatic sponge positioned on the catheter and arranged so as to extend substantially circumferentially around the outer surface of the catheter;a push member configured to engage the hemostatic sponge and push the sponge distally over the catheter, the push member comprising an elongate body having a proximal end and a distal end, a longitudinal lumen extending from the proximal end to the distal end of the body, the sponge having a greater diameter than the push member so that the push member engages only a portion of a side of the sponge; andan elongate release rod having a distal end disposed generally proximal the sponge, the rod configured to slidably fit through the push member lumen to engage its distal end with the sponge;wherein the hemostatic sponge is generally cohesive so that when the push member engages and pushes on only a portion of one side of the sponge, the entire sponge moves distally over the catheter as a cohesive unit; andwherein the push member and hemostatic sponge are disposed substantially proximal of the retractor when the retractor is in the closed position, and the push member and hemostatic sponge may only be advanced distally past the retractor when the retractor is in the open position. 40. The assembly of claim 39, wherein the catheter comprises an engagement portion adapted to engage edges of the puncture without being inflated, the uninflated engagement portion sized to flex the puncture edges sufficient to substantially plug the puncture. 41. The assembly of claim 40, wherein the catheter comprises a distal tip having a first outer diameter, and the engagement portion is proximal the distal tip and has a second diameter that is greater than the first diameter. 42. The assembly of claim 39, wherein the retractor has a plurality of elongate retractor arms, the retractor arms being movable between a closed position and an open position. 43. The assembly of claim 42, wherein the retractor is configured so that, when the retractor arms are in the opened position, an access passage is defined between the arms, the access passage sized so that the hemostatic sponge and the push member can slide therethrough. 44. The assembly of claim 39, wherein the hemostatic sponge and the push member are mounted onto the catheter so as to slide longitudinally over the catheter, and the hemostatic sponge is mounted distally of the push member. 45. The assembly of claim 44, wherein the sponge is mounted proximal of the retractor arms.