Abstract: A supportless atrioventricular valve intended for attaching to a circumferential valve ring and papillary muscles of a patient comprising a singular flexible membrane of tissue or synthetic biomaterial, wherein a minimally invasive delivery system is provided through a percutaneous intercostal penetration and a penetration at the cardiac wall into a left atrium of the heart.

Abstract: A gastric band implant characterized in that a strap constituted by an elongate piece is secured to the inside of an inflatable bag. The width and thickness of the piece are smaller than the corresponding dimensions of an oblong right cross-section of the bag. The piece possesses convex longitudinal edges and has complementary overlapping connection structures on opposite end portions of the strap.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

Abstract: A mold for forming medical balloons and the balloons formed therefrom are disclosed. The mold has a generally cylindrical inner molding surface for forming a working length of the balloon, and generally cylindrical outer molding surfaces at either end of the mold for forming shafts of the balloon. Joining these outer and inner molding surfaces are taper molding regions composed of two generally conical molding surfaces oriented at two different angles from a longitudinal axis of the mold. A balloon resulting from a manufacturing process using a mold according to the present invention reflects the geometry of the mold and has a unique concave taper profile and a well-defined working length.

Abstract: A catheter includes a distal end, a proximal end, an outer tube extending from the distal end to the proximal end, and an inner tube extending through the outer tube. The distal end including a corrugated section attached to an end of the inner tube and an asymmetric balloon attached to the outer tube and configured to deflect the distal end of the catheter.

Abstract: The object of the present invention is to provide an improved balloon catheter for curing aneurysms, and particularly dissecting aortic aneurysms, promptly and without surgical treatment, the therapeutic appliance for treating dissecting aortic aneurysms comprising providing a stretchable bag-like element on and along the end portion of a catheter, the bag-like element being in the form of a flat film when not holding a fluid inside and in the form of a tube when holding a fluid inside, and the inside film and outside film that compose the bag-like element are partially joined.

Abstract: A catheter with three spiral heat exchange elements surrounding a central supply tube and communicating with a source of heat exchange fluid in a closed loop for effecting patient temperature control and at least two infusion lumens for providing access to the central venous blood supply when the catheter is placed in the central venous system. An anchor can be provided to suture or tape the catheter to the skin of a patient.

Abstract: A balloon catheter having a balloon disposed upon an elongate shaft near a relatively rigid distal insertion tip, a fluid lumen for fluid communication with a body cavity and an inflation lumen for fluid communication with the balloon. The balloon holds the catheter tip within a body cavity such as the stomach for long-term enteral feeding. The balloon is configured such that upon inflation, the balloon distends distally to cover the distal tip thus insulating it from sensitive anatomy.

Abstract: A sealing valve assembly is provided for medical products. The valve assembly includes a valve member mountable within a passageway of a medical product body element, the valve member defining a peripheral portion spaced from a central axis and including two walls extending from the peripheral portion toward the central axis. The walls include ends that contact each other to preclude flow through the passageway. The valve member may be formed of a material having a durometer of less than about 20 Shore. The value member may also have a higher durometer material with other wall configurations, or may have a wall member having a varying durometer.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having an occlusion element, an aspiration lumen, and a blood outlet port in communication with the lumen, a guide wire having a balloon, a venous return catheter with a blood inlet port, and tubing that couples the blood outlet port to the blood inlet port. Apparatus is also provided for occluding the external carotid artery to prevent reversal of flow into the internal carotid artery. The pressure differential between the artery and the vein provides reverse flow through the artery, thereby flushing emboli. A blood filter may optionally be included in-line with the tubing to filter emboli from blood reperfused into the patient.

Abstract: An expansible tunneling apparatus and associated methods for creating an anatomic working space for a surgical procedure. Various embodiments of one and two piece apparatus that permit laparoscopic observation both during tunneling and during subsequent balloon dissection are disclosed. In a disclosed one piece embodiment, a tubular member has a bore extending therethrough and an open distal end. A lip is formed in the distal end of the tubular member to capture the distal tip of a laparoscope that is inserted into the tubular member to permit observation of the procedure both during tunneling to a desired location and during subsequent balloon inflation. An elongated neck of the balloon is secured to the tunneling member. The elongated neck permits the tubular member to be withdrawn slightly from the balloon after inflation to facilitate observation.

Abstract: A balloon device useful for dissecting tissue or retracting tissue for the purpose of providing access for laparoscopic surgery, the device comprising a balloon which inflates to a shape specially suitable for the surgical procedure and the anatomical region of deployment. The present device, when configured with a tapered dissection balloon, is particularly useful for subfascial endoscopic perforator surgical procedures.

Abstract: A dilatation balloon configured and formed to have a first inflation profile at a first pressure and a second inflation profile at a second higher pressure and methods of making and using the same.

Abstract: The present invention relates to a tracheal ventilating device, especially a tracheal tube or tracheal cannula which obturates the trachea as hermetically as possible for ventilating a patient, the device comprising a cuffed balloon which blocks the trachea below the glottis and through which a ventilating cannula is passed, with the cuffed balloon when filled or inflated and freely unfolded without any limitation, being larger than when placed in the trachea in an inflated state, and being made from a soft flexible foil material. To intubate a patient with said device as gently as possible at low pressures over a long period of time and with a low risk of infection, the invention suggests that the draped fold of the cuffed balloon should rest on the trachea and be designed in such a way that the loop created at the dead end of a fold has a small diameter which inhibits the free flow of secretion through the loop of said fold.

Abstract: A catheter apparatus for gaining access into the uterine cavity in order to perform minimally invasive surgery or diagnostic procedures related to a uterus and fallopian tubes, includes a single-lumen catheter; and an elongated balloon disposed distally on the single-lumen catheter for insertion into a cervical canal of the uterus. The balloon has opposing portions which occlude openings of the cervical canal when inflated. A fluid displacement sleeve is slidably disposed over the single-lumen catheter. The sleeve is moveable over the elongated balloon to inflate the portions of the balloon which are adjacent the opposite openings of the cervical canal when the balloon is inserted therein. Because there is no need for a balloon inflation lumen, the outer diameter of the catheter can be minimized and the cost of the apparatus is reduced.

Abstract: The present invention relates to a balloon catheter for positioning a stent, including a tubular basic body with a proximal end and a distal end, and at least one lumen extending in between, a balloon close to the distal end which is connected to the lumen, and a stent crimped around the balloon, wherein a filling body of elastic material is arranged inside the balloon and has a size corresponding to at least the dimensions of the stent in compressed state, where the filling body is compressed by the stent in the compressed state.

Abstract: A mold for forming medical balloons and the balloons formed therefrom are disclosed. The mold has a generally cylindrical inner molding surface for forming a working length of the balloon, and generally cylindrical outer molding surfaces at either end of the mold for forming shafts of the balloon. Joining these outer and inner molding surfaces are taper molding regions composed of two generally conical molding surfaces oriented at two different angles from a longitudinal axis of the mold. A balloon resulting from a manufacturing process using a mold according to the present invention reflects the geometry of the mold and has a unique concave taper profile and a well-defined working length.

Abstract: The invention refers to a device for fixing a tube member (1) in a cavity (2) of a patient. The device includes a body (3), which surrounds the tube member and has a casing (4) that at least partly forms an inner space (5). The body (3) is expandable by supplying a fluid to the inner space in such a way that the fluid in the inner space has a working pressure. Furthermore, the body (3) has, in a non-expanded state, a relatively small outer extent, which permits the introduction into said cavity (2), and in an expanded state, a relatively large outer extend, which permits fixing in said cavity by abutment with a contact pressure against a tubular wall (7) of the cavity. In order to ensure a tight abutment against the wall (7) of the cavity, the body (3) has such a geometrical shape that the contact pressure is substantially constant independent of variations of the working pressure within a normal working range.

Abstract: The present design envisions a flexible connecting link used in conjunction with in-phase and half-phase circumferential sets of strut members. By increasing the total length and diagonality of the undulating connecting links, the present design is a stent that provides increased flexibility during delivery and enhanced conformability to the shape of a curved artery when the stent is deployed into a curved vessel such as a tortuous coronary artery. Also, unique balloon-stent interactions are described.

Abstract: The invention provides a catheter for insertion into a biological passage which contains a first flowing fluid, the catheter including a tubular member having a proximal end and a distal end; a fluid delivery lumen contained within the tubular member; an inflatable balloon assembly disposed at the distal end of the tubular member, the balloon assembly including an inflatable balloon member having an uninflated state and an inflated state, the balloon assembly including apertures in communication with the fluid delivery lumen; an inflation lumen in communication with the balloon member; and a valve contained within the inflatable balloon assembly.

Abstract: A method and expandable device for thermally affecting tissue in which there is a fluid conduit. An expandable element includes a wall defining an inner volume. The wall has a tissue contact region which is non-coaxial with the longitudinal axis of the fluid conduit. The tissue contact region is operable to have a first contact surface area and a second contact surface area in which the second contact surface area is larger than the first contact surface area. A port is formed through the wall and is in fluid communication with the fluid conduit.

Abstract: A hydraulically expandable medical device for insertion into an obstruction in a blood vessel, comprising a hydraulically expandable tube having a clover leaf shape in its relaxed, deflated, position; and longitudinal ridges attached to the expandable tube and harbored in the clover leaf shape, the expandable tube adapted to be inflated and expanded with fluid, thereby pushing the elongated ridges outwardly into the obstruction material.

Abstract: A dilatation balloon configured and formed to have a first inflation profile at a first pressure and a second inflation profile at a second higher pressure and methods of making and using the same.

Abstract: Methods for forming low profile balloons for use with a catheter by providing a polymeric tube, removing material from the outer surface of the polymeric tube around at least one of its end portions, and inflating a region of the polymeric tube between the two end portions to form the balloon. Low profile balloons having end portions with an outer diameter below 30 mils are also disclosed.

Abstract: A method and expandable device for thermally affecting tissue in which there is a fluid conduit. The device including a housing having a first end region and a second end region, the second end region containing a fluid inlet and a fluid outlet, the housing being securable to a boney structure of the patient. An expandable element, including a wall defining an inner volume and a tissue contacting surface, is coupled to the housing first end region such that the inner volume is in fluid communication with the fluid inlet and the fluid outlet.

Abstract: A method and device for perfusing an organ system is provided. The device may be further described as a catheter or cannula with an expandable flow control member positioned of the distal portion of the catheter shaft. The flow control member has a porous portion, and at least one impermeable portion, which prevent fluid from flowing out the ends of the flow control member. The flow control member is further characterized as having an interior chamber that is in fluid communication with a perfusion lumen that extends along the length of the catheter shaft and is in fluid communication with an external perfusion pump. The perfusion lumen is configured for providing flow to the interior of the flow control member, to create radial expansion thereof and to provide adequate flow to the arch vessels through said porous portion to sustain the metabolic demands of the brain.

Abstract: Methods and apparatus are provided for removing emboli generated during a surgical procedure comprising a catheter having proximal and distal ends, a lumen extending therethrough, an occlusive member affixed to the distal end, and at least one blood intake port disposed in a lateral surface of the catheter. The occlusive member preferably is disposed in a treatment vessel, and the blood intake port, when uncovered, permits a portion of the antegrade flow from a host vessel to be diverted into the lumen of the catheter. A pressure differential caused by the blood intake from the host vessel establishes a venturi-effect suitable for manipulating flow in the treatment vessel. The flow characteristics may be manipulated via the intake port to direct emboli into the lumen of the catheter for subsequent removal.

Abstract: Laparoscopic apparatus and method for insertion into a space or potential space in a body including an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

Abstract: An inflatable member suitable for angioplasty or other medical procedures comprising asymmetric conic shoulder portions that optimize the wrapped profile. The asymmetry distributes the inflatable member material of the shoulder portions over a larger area to reduce the inflatable member profile and improve flexibility. Optionally, the asymmetrical shoulder portions preformed creases to facilitate folding. In an alternate embodiment, each shoulder portion has at least three radially spaced preformed creases to optimize folding in the shoulder portion. The invention also comprises methods of forming such inflatable members, the methods generally comprising using molds having the requisite characteristics. Specifically, the mold may have ridges within the areas corresponding the shoulder portions to form the preformed creases when the inflatable member is blow molded.

Abstract: A non-sheath balloon expandable stent delivery system (20) has a catheter-mounted balloon (25) whose ends (26, 27) are invaginated and folded over onto the balloon itself. Thus, when a stent (29) is mounted on the balloon, the balloon ends fold over the ends of the stent, thus covering its ends and serving a sheath function. The folded over ends (26A, 27A) could cover the terminal portions of the stent or could reach to the middle of the stent and cover the entire stent. When the balloon is inflated to deploy the stent; the balloon ends inflate and uncover the stent. The balloon inflation ports in the balloon catheter could be positioned so as to preferentially direct the inflating fluid into the balloon ends/invaginations (26A, 27A) to assure their inflation before the inflation of the body of the balloon.

Abstract: A probe having the ability to deliver cardioplegia solution to the coronary sinus under direct visualization and to provide venous drainage from the right atrium for cardiopulmonary bypass. The probe has an elongate tubular member, including a distal end, a proximal end, and a lumen. A membrane, optionally perforated, mounted within the lumen of the tubular member partitions the lumen and is removable or penetrable by a cardioplegia catheter. The distal end comprises a toroidal balloon or a circumferential recessed vacuum manifold. A vacuum port communicates with the distal end of the tubular member or the vacuum manifold. Methods of using the cardioplegia access view probe for catheterization of the coronary sinus and for venous return as herein described are also disclosed.

Abstract: An occlusion catheter for the ascending aorta capable of obstructing the blood flow within the ascending aorta without inserting through the femoral artery. The occlusion catheter is provided with a drug release aperture formed in the region, which is closer to the proximal end of the catheter tube than a balloon on the outer circumference of the distal end and which is to be located in the vicinity of the coronary ostium when the balloon is placed within the ascending aorta. The present occlusion catheter, when inserted directly into the ascending aorta in the vicinity of the heart to obstruct the blood flow therewithin, enables delivery of a cardiac muscle protective drug to the vicinity of the coronary ostium without inserting the occlusion catheter through the femoral artery in the conventional manner.

Abstract: A balloon catheter capable of expanding a narrowed site of a blood vessel in the vicinity of a curved part of the blood vessel, and of easily adapting the shape of the balloon to the shape of the curved part of the blood vessel. The balloon has a shape with a curved part, and the outer portion of the curved part (the shaded area) formed so as to have a smaller film thickness as compared with the remaining portion of the balloon is stretched by an amount larger than the remaining portion of the balloon. The difference in stretch amount between the outer portion of the curved part of the balloon and the remaining portion of the balloon becomes larger as the internal pressure of the balloon is increased. Accordingly, the extent of curve of the balloon can be controlled arbitrarily by controlling the internal pressure of the balloon.

Abstract: An intravascular radiation delivery system including a catheter, a radiation source disposed in an open-ended lumen in the catheter and a closed-ended sheath surrounding the radiation source so as to prevent blood and other fluids from coming into contact with the radiation source. Preferably, the open-ended lumen is centered in the balloon for uniform radiation delivery. The catheter may include a blood perfusion lumen under the balloon or around the balloon. The open-ended lumen in the catheter may have a reduced diameter adjacent the distal end of the catheter to prevent the radiation source from exiting the lumen. Methods of using the radiation delivery system are also disclosed. An alternative method of delivering radiation to a treatment site inside the vasculature of a patient using a gas-filled balloon catheter and a radiation source disposed in the balloon catheter. The treatment site is exposed to radiation, preferably beta radiation, through the gas-filled balloon.

Abstract: A method and device for occluding a patient's ascending aorta, maintaining circulation of oxygenated blood in the patient and delivering cardioplegic fluid to arrest the patient's heart. An aortic occlusion catheter has an occluding member for occluding the ascending aorta. The aortic occlusion catheter passes through a cannula. Delivery of oxygenated blood is accomplished through either the cannula or the aortic occlusion catheter.

Abstract: A catheter with three spiral heat exchange elements surrounding a central supply tube and communicating with a source of heat exchange fluid in a closed loop for effecting patient temperature control and at least two infusion lumens for providing access to the central venous blood supply when the catheter is placed in the central venous system. An anchor can be provided to suture or tape the catheter to the skin of a patient.

Abstract: The present invention provides an aortic catheter having an upstream occlusion member positioned in the ascending aorta between the coronary arteries and the brachiocephalic artery and a downstream anchoring member positioned in the descending aorta, downstream of the aortic arch. The upstream occlusion member is in the form of a narrow, disk-shaped inflatable balloon. The downstream anchoring member may be a larger inflatable balloon or other anchoring structure that provides sufficient friction to prevent migration of the balloon catheter in the upstream or downstream direction. In addition, an arch perfusion lumen, a corporeal perfusion lumen and a cardioplegia lumen are provided for performing selective perfusion and cardioplegic arrest.

Abstract: A cylindrical balloon for medical tubes, which is susceptible to bending operations, comprises a low stretchable section formed, by a partial cross-linking treatment, on the balloon along the circumferential direction thereof.

Abstract: Laparoscopic apparatus and method for insertion into a space or potential space in a body comprising an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

Abstract: A balloon catheter with a balloon having at least a section which has an uninflated configuration with at least two lobes and an inflated configuration with a cylindrical surface. In a presently preferred embodiment, the balloon has a lobed inner surface and a lobed outer surface. In one embodiment, the balloon has a uniform wall thickness around a circumference of the lobed balloon section. However, in alternative embodiments the balloon wall thickness may nonuniform around the balloon circumference. Each lobe forms a deflated balloon wing when the balloon is deflated.

Abstract: An inflatable medical balloon for multiple procedures, including angioplasty procedures, procedures for delivering medical devices, such as stents, and a method of making the catheter systems. The catheter system employs a balloon having a plurality of flexible portions and a combination of hard and soft portions.

Abstract: A catheter assembly including a balloon which incorporates a reverse-cone design for improved stent delivery. The reverse-cone design provides an inflatable area which extends longitudinally over the balloon waist. When folded or deflated, the portions of the balloon extending over the waist in conjunction with the waists provide a bulky mass onto which a stent may be securely crimped without the use of additional structure under the balloon.

Abstract: The present invention relates to a tracheal ventilating device, especially a tracheal tube or tracheal cannula which obturates the trachea as hermetically as possible for ventilating a patient, the device comprising a cuffed balloon which blocks the trachea below the glottis and through which a ventilating cannula is passed, with the cuffed balloon when filled or inflated and freely unfolded without any limitation, being larger than when placed in the trachea in an inflated state, and being made from a soft flexible foil material. To intubate a patient with said device as gently as possible at low pressures over a long period of time and with a low risk of infection, the invention suggests that the draped fold of the cuffed balloon should rest on the trachea and be designed in such a way that the loop created at the dead end of a fold has a small diameter which inhibits the free flow of secretion through the loop of said fold.

Abstract: A catheter and a method of using the catheter are disclosed that serve to create an efficient and rapid controlled manner of regulating a patient's body temperature. The catheter is a heat exchange catheter insertable into a blood vessel of a patient, circulating a heat exchange fluid therein, and including a spiral-shaped inflatable balloon that mixes laminar layers of the heat exchange fluid flowing inside the balloon.

Abstract: Laparoscopic apparatus and method for insertion into a space or potential space in a body including an introducer device having a tubular member with a bore extending therethrough. A tunneling shaft assembly is provided and is slidably mounted in the bore of the introducer device. The tunneling shaft assembly includes a tunneling shaft having proximal and distal extremities. A tunneling member is mounted on the distal extremity of the tunneling shaft. A balloon assembly is provided which is removably secured to the tunneling shaft. The balloon assembly includes a balloon wrapped about said tunneling shaft. A sheath is provided which encloses the balloon on the tunneling shaft. The sheath has a slit extending longitudinally thereof permitting the sheath to be removed whereby the balloon can be released and inflated. A tubular member is provided which has a balloon inflation lumen thereon and is coupled to the balloon for inflating said balloon.

Abstract: Methods and apparatus are provided for removing emboli during an angioplasty, stenting or surgical procedure comprising a catheter having a funnel-shaped occlusion balloon of uniform thickness disposed on a distal end of the catheter. The occlusion balloon is fused to the distal end so that it provides a substantially seamless flow transition into a working lumen of the catheter. Additionally, a distal edge of the occlusion balloon is configured to be in close proximity with an inner wall of a vessel to facilitate blood flow into the catheter and efficiently remove emboli.

Abstract: A catheter device for non-surgical entry into a uterus, includes a tubular body having a lumen extending from a first end thereof to a second end thereof, the lumen having an external opening adjacent to or at the first end for dispensing a diagnostic fluid into the uterus. An elongated balloon is disposed distally on the tubular body for insertion into the cervical canal of the uterus, the balloon having opposing portions which occlude opposing openings of the canal.

Abstract: A cylindrical balloon for medical tubes, which is susceptible to bending operations, comprises a low stretchable section formed, by a partial cross-linking treatment, on the balloon along the circumferential direction thereof.

Abstract: A direct-access device with a thin-profile balloon member is used to occlude a blood vessel. The device is ideally suited for occluding a patient's aorta during stopped-heart cardiac procedures. The device comprises a flexible, thin-profile balloon member which forms a balloon in combination with a tubular member, which inflates the thin-profile balloon member. Together, the balloon member and tubular member occlude a blood vessel. The balloon member is attached near the distal end of the tubular member. The width of the balloon member's outer peripheral contact area, which contacts the inner wall of the blood vessel, is substantially narrower than the balloon member's diameter. The balloon member is made of a low compliance material which prevents the balloon member from expanding by more than 40% radially and 50% longitudinally after the balloon member is initially inflated under ambient pressure to its normal, unstretched shape.

Abstract: The present invention provides balloon dissection apparatus and methods of use in which an elongate balloon is utilized to dissect along a region that follows a naturally existing path alongside a vessel or structure, such as an artery, a vein, a lymphatic vessel, the trachea, the esophagus, or even a nerve bundle.