Abstract: The present invention is directed to a cutting apparatus for cutting an opening in a vessel for subsequent anastomosis. The cutting apparatus includes an anvil, an anvil pull and a cutter. The anvil is inserted through a small incision at the anastomosis site and brought into contact with the interior wall of a vessel so that the anvil distends the wall of the vessel. The cutter is then urged against the portion of the vessel wall that is distended by the anvil to form an opening in the vessel wall.

Abstract: The present invention relates to new and useful apparatus, systems and methods for providing an effective tool for intraluminally directed vascular anastomosis of a graft vessel to a receiving blood vessel that is performed according to a minimally invasive procedure. The intraluminally directed vascular anastomosis does not require the interruption of blood flow in the receiving blood vessel and it is versatile enough to suitably combine a variety of cutting, welding, soldering, sealing, and joining techniques. The intraluminally directed anvil apparatus comprises an anvil and a wire used for signaling the optimal anastomosis site; this signaling can be performed when the initial exploration is performed. An anastomosis device is used in conjunction with the intraluminally directed anvil apparatus for opening the anastomosis fenestra and joining the anastomosed structures.

Abstract: Vascular access systems, devices and methods for facilitating repeated access to a blood vessel. These systems, devices and methods can be used in external blood treatment, such as dialysis, and in intra-venous administration of medicines, such as heparin, for extended periods of time, while avoiding deleterious effects such as those derived from repeated puncturing of the blood vessel tissues or exposure of such tissues to abnormal fluid flows. The vascular access systems comprise an anastomosis graft vessel, an occlusal device, such as an occlusal balloon, and a port device for accessing the occlusal device. Occlusal devices can be self-contained, they can rely on osmosis, and they can serve as the support of an agent to which the blood stream is exposed, either by transport or by mere contact. In addition, occlusal devices can adopt a distended and a collapsed configuration, the latter allowing for blood flow through the anastomosis graft vessel.

Abstract: A medical device assembly is adapted to isolate the heart from systemic circulation while perfusing oxygenated blood to the systemic arterial circulation during a minimally invasive bypasss procedure. An arterial catheter with an external shunt valve forms a funnel which shunts antegrade aortic blood flow from the aortic root, into a distal flow port and through an internal flow lumen in the catheter, out an intermediate flow port along the catheter proximally of the anchor, and into the systemic arterial circulation. A distal internal valve selectively occludes the shunted antegrade aortic blood flow between the distal flow port and the intermediate flow port and isolates the left heart chambers from the systemic arterial circulation. Oxygenated blood may then flow from a cardiopulmonary bypass pump, distally through the internal flow lumen, out the intermediate port.

Abstract: Compression plates and vascular anvils for anastomosis of structures including end-to-end and end-to-side anastomosis. Vascular anvils cooperate in the opening of the anastomosis fenestra, engagement by a compression plate and subsequent eversion of the anastomosis fenestra contour, and also in establishing the contact engagement of the anastomosed structures. Compression plates hold anastomosed structures while permitting their dilation and keeping the anastomosis leak-proof. One of the compression plates assists in the eversion of the anastomosis fenestra contour. These compression plates and vascular anvils can be used with or without catheterization in minimally invasive interventions.

Abstract: An ultrasound image of a transverse cross-sectional outline of the prostate gland is acquired. For three-dimensional imaging, a series of images can be taken, one of each slice of the prostate. The initial ultrasound images are pre-processed to remove the noise and increase the contrast. The rectum edge is located from the bottom of the images. The key points on the prostate boundaries are located and connected under the iterative training of a knowledge-based model until the shape of the boundary reaches a stable state. The urethra is segmented near the center of the prostate.

Abstract: Anastomosis procedures and anastomosis cutting procedures are achieved with an anvil apparatus that is externally positioned through the wall of a vessel into the vessel lumen. The externally positioned anvil apparatus has an anvil that engages a cutter to form a vessel opening. The anvil is larger than the cutter to enable the vessel to be cut as it is compressed between the cutter and the anvil. The anvil may have a spherical engaging end for use with a cylindrical cutter for forming circular openings in a manner such that the anvil self centers. The anvil and cutter may also be adapted to form elliptical openings. The balloon may be solid or deployable.

Abstract: Disclosed here within is the method of manufacture of a reinforced and flexible tube or catheter that can be used in a variety of applications. The first method of embedding the metallic coil or braided wire comprises the steps of engaging the metallic structure over the outer surface of the tubular member, applying heat through an appropriately sized mold to the outer surface of the tubular member while creating a pressure differential between the inner lumen and the outside surface of the tubular member for a specified period of time.

Abstract: A harness assembly (16) having an integral support line (20). The harness assembly (16) includes a harness body (18) having first and second ends (22, 24) and a hollow interior which receives the support line (20). The support line (20) has first and second ends (22, 24) that extend from the harness body (18). The harness (16) is secured within a garment (10). The garment (10) has a front opening (34) which is normally covered by a releasable flap (36). The first and second ends (22, 24) of the support line (20) extend through the front opening (34) and are accessible when the flap (36) is moved to an open position. The first end (22) of the support line (20) may be pulled away from the harness (16) to extend the support line therefrom. The second end (24) of the support line is secured to the harness (16).

Abstract: The present invention is directed to an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein. The struts of the present invention have a specific trapezoidal, triangular or a reduced radii configuration projecting radially outward that functions to reduce the forces necessary to penetrate the vessel wall thereby minimizing trauma or damage imparted to the wall during deployment. In addition, this design feature of the present invention helps secure the expanded stent so that it does not move once it is implanted and furthermore, minimizes projections into the blood stream. The invention generally includes a plurality of radially expandable loop elements which are relatively independent in their ability to expand and to flex relative to one another.

Abstract: A placement plan is developed for the placement of radioactive seeds in a prostrate for brachytherapy. The placement plan is made available to an intraoperative tracking interface which also shows a live ultrasound image of the needle or catheter placement in the prostate. The difference in the x-y plane between the planned and actual locations of the needle or catheter is calculated, and from that difference, the error in position of each seed is calculated. The seeds are moved, or the operator changes the number of seeds, and the dose is recalculated. A small column of ultrasound images is taken, and each seed located in the column of images is given a confidence level. If the confidence level exceeds a threshold set by the operator, the dosimetry is recalculated. Periodically throughout the seed placement, fluoroscopic x-rays are taken, and the seed coordinates are matched to the x-ray image.

Abstract: A device for folding a balloon of a balloon catheter during balloon deflation includes a band and a plurality of elongated fingers that are attached to the band. The band is formed with a tab and a notch and the length of the band corresponds to the diameter of the catheter tube. The band is folded into an annulus to interlock the tab with the notch. The annulus is attached to the catheter tube of the balloon catheter with the fingers extending over the balloon in a substantially same axial direction. In operation, the fingers are moveable between an unstressed configuration, when the balloon is deflated, and a stressed configuration, when the balloon is inflated. In a stressed configuration, the fingers urge against the balloon and are biased toward the stressed configuration to return to an unstressed configuration.

Abstract: The present invention is directed to an expandable stent which is relatively flexible along its longitudinal axis to facilitate delivery through tortuous body lumens, but which is stiff and stable enough radially in an expanded condition to maintain the patency of a body lumen such as an artery when implanted therein. The struts of the present invention have a specific trapezoidal, triangular or a reduced radii configuration projecting radially outward that functions to reduce the forces necessary to penetrate the vessel wall thereby minimizing trauma or damage imparted to the wall during deployment. In addition, this design feature of the present invention helps secure the expanded stent so that it does not move once it is implanted and furthermore, minimizes projections into the blood stream.

Abstract: A medical instrument which is insertable into a vascular system to incise a stent embedded within a stenosis is provided herein and includes a multi-luminal catheter with a distal expandable balloon mounted with a reciprocating cutting member. The cutting member is selectively activated by an external reciprocating mechanism which is transmitted through the catheter to the cutting member mounted on the balloon's surface. The cutting member is designed to have the characteristics necessary to cut the metallic struts of a stent. In operation, the device is placed within the stenosis having an embedded stent and the expandable balloon is inflated. Preferably, the cutting member will be facing the myocardium. Then reciprocating motion is activated and the cutting member proceeds to sever the struts of the stent and make an incision in the stenosis. It is anticipated that more than one cutting member may be mounted on the balloon's surface.

Abstract: The present invention is a device and a method for boring a perfusion channel from a coronary artery into a cardiac muscle of a patient. Structurally, the present invention includes a positioning catheter, anchor means and a cutting catheter. The cutting catheter includes a plurality of blades and is advanceable through a deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes a distal end of the cutting catheter to project laterally from the positioning catheter. In use, the positioning catheter is positioned within the coronary artery. The anchor means is then expanded to anchor the positioning catheter within the artery. The cutting catheter is then advanced through the deployment lumen to bore one or more perfusion channels in the myocardial tissue.

Abstract: The present invention is a device for incision and dilation of stenotic segments within the vascular system of a patient. Structurally, the present invention includes a rigid ellipsoidal dilation probe mounted at the distal end of a catheter. A series of longitudinally oriented blades project radially from the surface of the probe. A tapered inflatable balloon is also mounted on the catheter in a position that is proximal to the dilation probe. In use, the probe and catheter are advanced over a guidewire to reach the targeted stenotic segment. The probe and blades are then advanced through the stenotic segment to incise the stenosis. The balloon may then be inflated to adopt a tapering fusiform shape, allowing the balloon to be advanced through the stenosis to further dilate the stenosis. Alternatively, the balloon may be positioned across the stenosis and inflated to dilate the stenosis.

Abstract: A medical device system and method allows an arterial bypass graft to be proximally anastomosed to an aorta during a beating heart CABG procedure without substantial loss of blood by use of an endolumenal aorta isolation assembly provided along the distal end portion of an elongate catheter body. The aorta isolation assembly includes proximal and distal portions that are separated by an intermediate isolation region and that are adjustable to first and second extended positions, respectively, which are adapted to circumferentially engage the aortic wall and isolate upstream and downstream aspects of an exterior space between the elongate body and the aortic wall. Blood flowing within the aorta is thereby isolated from the proximal anastomosis site along the intermediate region and is shunted from an upstream region of the aorta, through the distal port into the flow lumen, proximally along the flow lumen, out from the flow lumen through the proximal port, and into a downstream region of the aorta.

Abstract: A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device includes a plurality of flexible tubes mounted between a multi-lumen catheter and a grommet. A push-pull wire is connected to the grommet and passed through a lumen of the multi-lumen catheter. The dispensers are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel.

Abstract: The present invention is a device and a method for boring a perfusion channel from a coronary artery into a cardiac muscle of a patient. Structurally, the present invention includes a positioning catheter, anchoring structure and a cutting catheter. The cutting catheter includes a plurality of blades and is advanceable through a deployment lumen of the positioning catheter. Advancement of the cutting catheter through the deployment lumen causes a distal end of the cutting catheter to project laterally from the positioning catheter. In use, the positioning catheter is positioned within the coronary artery. The anchoring structure is then expanded to anchor the positioning catheter within the artery. The cutting catheter is then advanced through the deployment lumen to bore one or more perfusion channels in the myocardial tissue.

Abstract: A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device includes a plurality of flexible tubes mounted between a multi-lumen catheter and a grommet. A push-pull wire is connected to the grommet and passed through a lumen of the multi-lumen catheter. The dispensers are mounted on each of the flexible tubes. During use, the device is first positioned in a vessel.