Abstract: A system for sealing a large penetration in the wall of a femoral artery comprises an occlusion catheter and an applicator. An access catheter may further be provided in order to facilitate introduction of the occlusion catheter. The occlusion catheter is introduced through a contralateral penetration, advanced over the aortic bifurcation, and an occlusion element on the occlusion catheter is positioned at the large diameter penetration. The occlusion element is then inflated to temporarily seal the large penetration while blood perfusion past the occlusion element is provided by the catheter. A sealing material, such as a tissue adhesive or other hemostatic agent is then introduced into a tissue tract above the large diameter penetration in order to seal the penetration. The occlusion element may be left in place while the sealing material has time to set, cure or otherwise form a permanent seal of the large penetration. The occlusion catheter and all access sheaths may then be removed from the patient.

Abstract: Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with chemical and/or biological agents to accelerate the hemostatic process. One method includes the steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A chemical and/or biological sealing member disposed proximal the expansible member is then displaced so as to expose a chemical and/or biological region or release region of the device. At least one chemical and/or biological agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.

Abstract: The present invention provides devices, systems, and methods for percutaneously sealing a puncture site in tissue tracts and vessels in human or animal bodies. One system includes a locating assembly that is used to locate the puncture site and can also provide temporary hemostasis when the system is used for closing a vessel puncture. The system also includes a compression assembly comprising a tubular member with a balloon on a distal end thereof. This balloon is at a fixed distance from the locator tip which locates the balloon outside the vessel wall at a predetermined distance. Inflation of this balloon causes forward elongation of the balloon which compresses subcutaneous tissue between the distal tip of the balloon and the vessel wall. This tissue compression against the puncture site is the mechanism that provides hemostasis.

Abstract: Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an occlusion element, a hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element temporarily occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus and left in place to enhance closure of the vascular wall penetration with minimum scarring. The implant may be radiopaque to allow observation before release.

Abstract: Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with bio-chemical agents to accelerate the hemostatic process. One method includes the steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A bio-chemical sealing member disposed proximal the expansible member is then displaced so as to expose a bio-chemical region or release region of the device. At least one bio-chemical agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.

Abstract: The present invention advantageously provides devices, systems, and methods for percutaneous access and closure of vascular puncture sites. In an embodiment, the device for enhancing the hemostasis of a puncture site in a body lumen or tract comprises a catheter having one tubular member having a proximal end and a distal end with one inner lumen extending between at least a longitudinal portion of the catheter tubular member. The one tubular member includes external and internal tubular bodies each having proximal and distal ends. At least one of the external and the internal tubular bodies is longitudinally movable with respect to the other. An expansible member with proximal and distal ends is disposed on the distal end of the one tubular member. The distal end of the expansible member is connected to the distal end of internal tubular body and with its proximal end connected to the distal end of external tubular body.

Abstract: The present invention advantageously provides devices, systems, and methods for percutaneous access and closure of vascular puncture sites. In an embodiment, the device for enhancing the hemostasis of a puncture site in a body lumen or tract comprises a catheter having one tubular member having a proximal end and a distal end with one inner lumen extending between at least a longitudinal portion of the catheter tubular member. The one tubular member includes external and internal tubular bodies each having proximal and distal ends. At least one of the external and the internal tubular bodies is longitudinally movable with respect to the other. An expansible member with proximal and distal ends is disposed on the distal end of the one tubular member. The distal end of the expansible member is connected to the distal end of internal tubular body and with its proximal end connected to the distal end of external tubular body.

Abstract: Self-tensioning occlusion devices and systems provide percutaneous access and closure of vascular puncture sites. One device includes a catheter body having a proximal end and a distal end, an occlusion member, and a tensioning member. The occlusion member, for example an expansible member, is disposed on a distal end of the body. The tensioning member, such as a spring or coil, is slidably disposed over the body and proximal to the expansion member. Generally, during application, the tensioning member will be positionable against subcutaneous tissue so as to lodge and anchor the expansible member against the puncture site. In particular, the expansible member allows for sealing of the puncture site while the tensioning member applies and maintains tension to the expansible occluder so that it is seated against the puncture site at a vascular surface.

Abstract: Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an optional occlusion element, a hydratable hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element optionally occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hydratable hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus by retracting the protective sleeve and left in place to enhance closure of the vascular wall penetration with minimum scarring. The hydratable implant will be protected from premature hydration and swelling by a soluble plug covering the implant's distal end prior to sleeve retraction.

Abstract: A device for expansion within a blood vessel having a wall defining a lumen in the body. The device comprises an elongated tubular member having proximal and distal extremities and having a longitudinal axis. An expansile member is carried by the distal extremity of the elongated tubular member and is movable between contracted and expanded configurations. A deformable membrane having proximal and distal outer surfaces at least partially covers the expansile member in the expanded configuration. The proximal and distal outer surfaces have substantially different configurations when the expansile member is in the expanded configuration. Deployment means is carried by the proximal extremity of the elongated tubular member and is coupled to the expansile member for moving the expansile member between the contracted and expanded configurations. A handle assembly is carried by the proximal extremity of the elongated tubular member and coupled to said deployment means.

Abstract: Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an occlusion element, a hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element temporarily occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus and left in place to enhance closure of the vascular wall penetration with minimum scarring. The implant may be radiopaque to allow observation before release.

Abstract: A system for sealing a large penetration in the wall of a femoral artery comprises an occlusion catheter and an applicator. An access catheter may further be provided in order to facilitate introduction of the occlusion catheter. The occlusion catheter is introduced through a contralateral penetration, advanced over the aortic bifurcation, and an occlusion element on the occlusion catheter is positioned at the large diameter penetration. The occlusion element is then inflated to temporarily seal the large penetration while blood perfusion past the occlusion element is provided by the catheter. A sealing material, such as a tissue adhesive or other hemostatic agent is then introduced into a tissue tract above the large diameter penetration in order to seal the penetration. The occlusion element may be left in place while the sealing material has time to set, cure or otherwise form a permanent seal of the large penetration. The occlusion catheter and all access sheaths may then be removed from the patient.

Abstract: The present invention advantageously provides self-tensioning occlusion devices, systems, and methods for percutaneous access and closure of vascular puncture sites. One device includes a catheter body, an occlusion member, and a tensioning member. The occlusion member, such an expansible member, is disposed on a distal end of the body. The tensioning member, such as a spring or coil, is slidably disposed over the body and proximal the expansion member. Generally, during application, the tensioning member will be deployed against subcutaneous tissue so as to apply tension to the expansible member against the puncture site. The substantial hold once the tension is applied is then provided by an external element, such as an anchoring clip.

Abstract: The present invention advantageously provides devices, systems, and methods for percutaneous access and closure of vascular puncture sites. In an embodiment, the device for enhancing the hemostasis of a puncture site in a body lumen or tract comprises a catheter having one tubular member having a proximal end and a distal end with one inner lumen extending between at least a longitudinal portion of the catheter tubular member. The one tubular member includes external and internal tubular bodies each having proximal and distal ends. At least one of the external and the internal tubular bodies is longitudinally movable with respect to the other. An expansible member with proximal and distal ends is disposed on the distal end of the one tubular member. The distal end of the expansible member is connected to the distal end of internal tubular body and with its proximal end connected to the distal end of external tubular body.

Abstract: Apparatus for sealing vascular penetrations comprise a shaft having an electrode or other energy-applying element at a distal end. The shaft is placed in a tissue tract over a blood vessel penetration and located using a locator which engages an inner wall of the blood vessel. Once in position, an anchor is used to hold the shaft, allowing the locator to be removed. Energy is then applied through a distal tip of the shaft in order to induce desiccation and plug formation in a blood pool formed between the distal end of the shaft and the wall of the blood vessel.

Abstract: Apparatus for sealing a vascular wall penetration disposed at the end of the tissue tract comprises a shaft, an occlusion element, a hemostatic implant, and a protective sleeve. The apparatus is deployed through the tissue tract with the occlusion element temporarily occluding the vascular wall penetration and inhibiting backbleeding therethrough. The hemostatic implant, which will typically be a biodegradable polymer such as collagen carrying an anti-proliferative agent or coagulation promoter, will then be deployed from the sealing apparatus and left in place to enhance closure of the vascular wall penetration with minimum scarring. The implant may be radiopaque to allow observation before release.

Abstract: Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with bio-chemical agents to accelerate the hemostatic process. One method includes the steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A bio-chemical sealing member disposed proximal the expansible member is then displaced so as to expose a bio-chemical region or release region of the device. At least one bio-chemical agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.

Abstract: Drug eluting vascular closure devices and methods for closing a blood vessel puncture site disposed at a distal end of a tissue tract are described. The devices and methods rely on a combination of the body's own natural mechanism to achieve hemostasis with bio-chemical agents to accelerate the hemostatic process. One method includes the steps of introducing a closure device through the tissue tract and deploying an expansible member at a distal end of the device within the blood vessel to occlude the puncture site. A bio-chemical sealing member disposed proximal the expansible member is then displaced so as to expose a bio-chemical region or release region of the device. At least one bio-chemical agent is thereafter released from the device and into the tissue tract to accelerate the occlusion process in the tract.

Abstract: The present invention advantageously provides self-tensioning occlusion devices, systems, and methods for percutaneous access and closure of vascular puncture sites. One device comprises a catheter body having a proximal end and a distal end, an occlusion member, and a tensioning member. The occlusion member, such an expansible member, is disposed on a distal end of the body. The tensioning member, such as a spring or coil, is slidably disposed over the body and proximal the expansion member. Generally, during application, the tensioning member will be positionable against subcutaneous tissue so as to lodge and anchor the expansible member against the puncture site. In particular, the expansible member allows for sealing of the puncture site while the tensioning member applies and maintains tension to the expansible occluder so that it is seated against the puncture site at a vascular surface.

Abstract: The present invention advantageously provides self-tensioning occlusion devices, systems, and methods for percutaneous access and closure of vascular puncture sites. One device comprises a catheter body having a proximal end and a distal end, an occlusion member, and a tensioning member. The occlusion member, such an expansible member, is disposed on a distal end of the body. The tensioning member, such as a spring or coil, is slidably disposed over the body and proximal the expansion member. Generally, during application, the tensioning member will be positionable against subcutaneous tissue so as to lodge and anchor the expansible member against the puncture site. In particular, the expansible member allows for sealing of the puncture site while the tensioning member applies and maintains tension to the expansible occluder so that it is seated against the puncture site at a vascular surface.