Abstract: Improved devices and components for securing and retrieving an implantable medical device including at least one of a flanged tip disposed at a distal end of the implantable medical device; a halo retrieval tip disposed at a distal end of the implantable medical device; an external leash disposed at least one of a proximal end, a midportion, and a distal end of the implantable medical device; and an internal leash disposed within an inflatable balloon of the implantable medical device. A method of retrieving an implantable medical device, comprising: securing a retrieval device to at least one of the components described herein; and removing the implantable medical device from a patient.

Abstract: According to embodiments, disclosed is an inflation and deflation device for an inflatable medical device, comprising: an inflation tubing disposed between an access block and a roller configured to rotate about an axis of a roller head; wherein the inflation tubing provides fluid communication between a container and the inflatable medical device; wherein the access block and the roller are configured to restrict flow through the inflation tubing at the area of pressure between the roller and the access block; and wherein the rotation of the roller about the axis of the roller head is configured to transport a fluid within the inflation tubing.

Abstract: A deflation catheter device, comprising: a catheter tube having a proximal end and a distal end; a stylet disposed within the catheter tube; a stylet handle attached to the stylet; and a y-connector disposed near a proximal end of the catheter tube, configured to provide fluid communication from the distal end of the catheter tube and a suction port, and configured to provide access for the stylet from the proximal end of the catheter tube to the distal end of the catheter tube.

Abstract: A biopsy cannula and a delivery catheter are configured to deliver one or more absorbable sponge pledgets to a biopsy site after removal of one or more tissue samples from the site. The delivery catheter allows a large amount of hydrated sponge material to be delivery to the biopsy site to facilitate hemostasis. One example of the delivery catheter includes a closed distal end, a side port, a tapered section, and an enlarged proximal portion for receiving the pledget. The side port of the delivery catheter is arranged to delivery the pledget through the side port of the biopsy cannula. In order to fill a relatively large biopsy site where multiple tissue samples have been taken in a radial pattern, the biopsy cannula is rotated and additional pledgets are delivered to the biopsy site at different radial locations. The absorbable sponge pledget may also be used as a marker for location of the biopsy site at a later time.

Abstract: The present invention provides for a method and apparatus to provide hemostasis at a puncture site having a communication tube with a lumen, a top and a bottom; a hemostatic material positioned around the communication tube bottom, the hemostatic material having a first end and a second end; and a hemostatic material cover positioned around the hemostatic material and the communication tube bottom, wherein the hemostatic material cover forms a hollow distal tip cavity at the hemostatic material first end.

Abstract: A solution is provided to release a tissue cinching loop within a body having a first thread having a first end and a second end, and a second thread having a first half having a first tip, a second half having a second tip, a bottom half having a link, and a top half, wherein the first end is inserted through the link. A first knot is formed around the first thread with the top half thereby forming a loop where the diameter of the loop decreases as the knot is pushed into the body and the first thread is pulled out of the body and where the loop is released within the body when the first end is pulled out of the body.

Abstract: The present invention provides for a method and apparatus to provide hemostasis at a blood vessel puncture site, having a hemostasis material and a clot formation accelerator, wherein said clot formation accelerator is substantially dispersed throughout said hemostasis material.

Abstract: An in vitro testing process for simulating conditions of a stomach, comprising, in combination: providing an intragastric device to an acetone bath; inducing swelling of the intragastric device; exacerbating weak spots in the intragastric device; observing the results; and estimating the results of an in vivo study. Improvements to an intragastric space filler to reduce failure at a balloon to shaft area including an adhesive fillet, washers, a balloon cuff and collar, a molded in balloon fillet, and a one-piece molded balloon assembly.

Abstract: An in vitro testing process for simulating conditions of a stomach, comprising, in combination: providing an intragastric device to an acetone bath; inducing swelling of the intragastric device; exacerbating weak spots in the intragastric device; observing the results; and estimating the results of an in vivo study. Improvements to an intragastric space filler to reduce failure at a balloon to shaft area including an adhesive fillet, washers, a balloon cuff and collar, a molded in balloon fillet, and a one-piece molded balloon assembly.

Abstract: A deflation device including a catheter having a proximal opening at a proximal end and a distal opening at a distal end; and a coring member disposed within the catheter and comprising a handle disposed near the proximal end of the catheter, a cable, and a coring tip disposed near the distal end of the catheter; wherein pressing said distal end of said catheter against said wall of said balloon creates a substantially normalized surface of said balloon relative to a coring tip and wherein the coring tip is a sharpened, hollow cylinder. A method for deflating and removing an implantable, inflatable device comprising: pressing a distal end of a catheter against the wall of an inflated balloon of an implanted device; advancing the coring tip within the catheter beyond the distal end of the catheter and into the balloon, whereby a hole adapted for advancing the catheter is created in the wall of the balloon; and advancing the catheter into the balloon.

Abstract: A device, system and method for improving delivery of hemostatic material, in which the device includes a vent cap body capable of removably engaging a cannula. The vent cap has a passage extending through the vent cap body from the cannula to an exterior of the vent cap body where a restricter for restricting the flow of fluid from the cannula to the exterior. In one embodiment, the vent cap has a valve which has an opened and closed position. In the closed position, the valve is designed to provide a back pressure or resistance. When a certain force is applied against the valve, the valve moves from the closed position to the opened position, where a gas or fluid may pass through the vent cap. The vent cap is designed to help maintain the continuity of the hemostatic material during delivery of the material from the adaptor to the trial staging chamber.

Abstract: The present invention provides for an apparatus to locate a blood vessel puncture having a bleed back entrance port near a first end, a bleed back exit port near a second end; and a lumen extending between the bleed back entrance port and the bleed back exit port, wherein said bleed back entrance port has a diameter substantially equal to or greater than the lumen diameter. The present invention further provides for a method for locating a blood vessel puncture by inserting a locator into a blood vessel lumen, the locator having a bleed back entrance port at a first end, a bleed back exit port at a second end, and a finger adjacent the bleed back entrance port, observing a blood flow out of the bleed back exit port, and withdrawing the locator out of the blood vessel lumen until the finger contacts the blood vessel wall.

Abstract: A method of facilitating hemostasis of a blood vessel puncture. The method includes the steps of inserting a tubular device into a puncture in a blood vessel to establish access to the blood vessel, providing a vessel closure system around the tubular device, introducing a hemostatic material into a space between the tubular device and vessel closure system, and delivering the hemostatic material adjacent to the puncture to facilitate hemostasis of the puncture.

Abstract: A system for facilitating hemostasis of a puncture site in a blood vessel injects an absorbable sponge pledget in a hydrated state to a position at an exterior of the blood vessel puncture to facilitate hemostasis. The system includes a tract dilator for locating the puncture, an introducer, and a pusher. The introducer includes a staging chamber for receiving the absorbent sponge pledget and a delivery chamber having a diameter smaller than a diameter of the staging chamber into which a hydrated pledget passes. The pledget is hydrated and compressed within the introducer and then ejected with the pusher to the delivery site to facilitate hemostasis of the blood vessel puncture. The system delivers the absorbable sponge pledget over a guidewire to ensure the proper positioning of the pledget over the puncture. The implanted absorbable sponge once delivered expands rapidly to fill the target site and is absorbed by the body over time.

Abstract: An absorbable sponge containing a contrasting agent (e.g., radiopaque agent) that can be introduced to a biopsy tract or other puncture wound site is provided. The contrasting agent permits identification of the site by fluoroscopy or other imaging techniques.

Abstract: A depth and puncture control system for a blood vessel hemostasis system includes a blood vessel puncture control tip which, when positioned in the lumen of a blood vessel, can inhibit the flow of blood out of the puncture site. When used together with a pledget delivery cannula and a pledget pusher, the control tip and the delivery catheter can both inhibit blood loss out the puncture site and inhibit the introduction of pledget material and tissue fragments into the blood vessel. The system also includes a handle which releasably connects together the control tip, pusher, and delivery cannula to permit limited longitudinal motion between the control tip and the delivery cannula, and between the pusher and the delivery cannula.

Abstract: A method of facilitating hemostasis of a blood vessel puncture. The method includes the steps of inserting a tubular device into a puncture in a blood vessel to establish access to the blood vessel, providing a vessel closure system around the tubular device, introducing a hemostatic material into a space between the tubular device and vessel closure system, and delivering the hemostatic material adjacent to the puncture to facilitate hemostasis of the puncture.

Abstract: An absorbable sponge containing a contrasting agent (e.g, radiopaque agent) that can be introduced to a biopsy tract or other puncture wound site is provided. The contrasting agent permits identification of the site by fluoroscopy or other imaging techniques.

Abstract: A system for facilitating hemostasis of a puncture site in a blood vessel injects an absorbable sponge pledget in a hydrated state to a position at an exterior of the blood vessel puncture to facilitate hemostasis. The system includes a tract dilator for locating the puncture, an introducer, and a pusher. The introducer includes a staging chamber for receiving the absorbent sponge pledget and a delivery chamber having a diameter smaller than a diameter of the staging chamber into which a hydrated pledget passes. The pledget is hydrated and compressed within the introducer and then ejected with the pusher to the delivery site to facilitate hemostasis of the blood vessel puncture. The system delivers the absorbable sponge pledget over a guidewire to ensure the proper positioning of the pledget over the puncture. The implanted absorbable sponge once delivered expands rapidly to fill the target site and is absorbed by the body over time.

Abstract: An apparatus for inhibiting blood loss from a puncture site. The apparatus may include means for locating a puncture site in a blood vessel wall. This apparatus is comprised of a tube and an elongated member that is positioned around the tube. The elongated member includes a proximal end and a distal end. Around the tube is also a dissolvable distal capsule, the distal capsule including a proximal end and a distal end, wherein the proximal end of the distal capsule attaches to the distal end of the elongated member. Inside the distal capsule is hemostatic material such as a sponge.