Abstract: A full-body harness, with or without an integral support line, with the harness being adaptable for class I, class II, and/or class III service, and for use by safety personnel (such as firefighters, military personnel, rescue workers etc.) or others for situations that call for emergency activity in areas where falls from an unsafe height are possible, or for use for entertainment purposes such as climbing, rappelling, or skydiving, for example.

Abstract: A full-body harness, with or without an integral support line, with the harness being adaptable for class I, class II, and/or class III service, and for use by safety personnel (such as firefighters, for example) for situations that call for emergency activity in areas where falls from an unsafe height are possible.

Abstract: A medical device system and method allows an arterial bypass graft to be proximally anastomosed to an aorta during a beating heart 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 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. The intermediate region is adapted to be positioned along the proximal anastomosis site such that the distal and proximal portions when adjusted to the first and second extended positions circumferentially engage the aortic wall on upstream and downstream sides of the proximal anastomosis site.

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: 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: 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.

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

Abstract: Guidewire comprising an elongated core element manufactured from a martensitic alloy that is heat-treated to render a fully hardened core throughout its cross sectional area. The core has a constant taper or step-down decreasing cross sectional area in a direction towards the distal end which is fully hardened throughout its longitudinal length. A single coil, or two coils are carried by and secured to said core element near the distal end.