Abstract: Implantable osmotic pump devices and systems include multiple osmotic pumps and/or semipermeable membranes to extend the useful life cycle and functionality of the drug delivery system. Use of an implantable system including multiple implantable osmotic pumps allows different drugs to be administered from the same implanted system. One or more of the semipermeable membranes of the system may be initially sealed by an overlying impermeable membrane upon implantation of the system into the patient. When the patient develops a tolerance to a first drug or to a first dose of the first drug, the impermeable membrane may be breached, to expose the underlying semipermeable membrane to the osmotic pressure of the patient at the implant site. This causes the infusion rate to increase, thereby providing the patient with the needed relief and/or other desired therapeutic effect. In the case of a multiple pump system, breaching an impermeable membrane may cause the infusion of a second drug.

Abstract: Methods and apparatus for crossing totally to substantially occluded blood vessels by passing a redirectable wire such as a guidewire from a relatively proximal point past the occlusion within a subintimal space formed between the intimal layer and the adventitial layer of a blood vessel wall. The wire may be advanced to a point distal to the occlusion, and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. The deflecting catheter may include a flapper valve assembly or preformed actuator wire for redirecting the guidewire. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn, and the guidewire may be available for introduction of other interventional and diagnostic catheters for performing procedures such as stenting.

Abstract: Total occlusions are crossed by passing a guidewire or other penetrating wire from a point proximal to the occlusion into a subintimal space between the intimal layer and adventitial layer of the blood vessel wall. The wire is advanced to a point distal to the occlusion and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.

Abstract: An intravascular catheter system for the treatment of occluded blood vessels that includes tissue displacement or hinged expansion members that are movable from a closed to an open position. An actuating assembly may be, provided for moving the tissue expansion members between an open and closed position to exert a substantially lateral distal end force upon the region surrounding an occluded blood vessel. The tissue expansion members may stretch apart, tear or otherwise disrupt a vascular occlusion sufficiently to create a pathway that may support the passage or placement of a guidewire or an interventional vascular device across the occlusion or obstruction. Methods of crossing or displacing a vascular occlusion are further provided that include the positioning of a vascular catheter having at least one hinged spreading member positioned at the distal region of the catheter that is responsive to directed force along the longitudinal axis of the catheter.

Abstract: An implantable osmotic pump for delivering a pharmaceutical agent to a patient includes an osmotic engine, a substantially toroidal compartment disposed at least partially around the osmotic engine and a piston disposed within the compartment. The osmotic engine is configured to cause the piston to travel within the compartment and deliver a dose pharmaceutical agent contained within the compartment when the pump is implanted in an aqueous environment. A dose escalation assembly may be fitted to the pump, the dose escalation assembly being adapted to selectively increase the rate at which the pharmaceutical agent is delivered from the pump.

Abstract: Implantable osmotic pump devices and systems include multiple osmotic pumps and/or semipermeable membranes to extend the useful life cycle and functionality of the drug delivery system. Use of an implantable system including multiple implantable osmotic pumps allows different drugs to be administered from the same implanted system. One or more of the semipermeable membranes of the system may be initially sealed by an overlying impermeable membrane upon implantation of the system into the patient. When the patient develops a tolerance to a first drug or to a first dose of the first drug, the impermeable membrane may be breached, to expose the underlying semipermeable membrane to the osmotic pressure of the patient at the implant site. This causes the infusion rate to increase, thereby providing the patient with the needed relief and/or other desired therapeutic effect. In the case of a multiple pump system, breaching an impermeable membrane may cause the infusion of a second drug.

Abstract: An implantable osmotic pump system includes a rigid pump housing defining an opening adapted to receive a catheter; one or more membrane assemblies fitted to the pump housing; an osmotic engine within the rigid pump housing and a flexible pharmaceutical agent compartment disposed within the pump housing. The flexible pharmaceutical agent compartment is adapted to enclose a volume of a pharmaceutical agent and to cause the pharmaceutical agent to be infused through the opening as water crosses the membrane assembly or assemblies and increases the volume of the osmotic engine. The flexible pharmaceutical agent compartment may include polyethylene teraphthalate (PET), for example, and/or may include a metallic layer such as gold, silver, platinum and/or aluminum, for example, to inhibit the transfer of gas or liquid across the compartment. A catheter may be bonded to the opening of the pump housing and to a corresponding opening in the flexible pharmaceutical agent compartment.

Abstract: Implantable devices and osmotic pump and catheter systems for delivering a pharmaceutical agent to a patient at selectable rates include an impermeable pump housing and a moveable partition disposed within the housing, the partition dividing the housing into an osmotic driving compartment having an open end and a pharmaceutical agent compartment having a delivery orifice. A plurality of semi permeable membranes may be disposed in the open end of the osmotic driving compartment and a number of impermeable barriers may seal selected ones of the plurality of semi permeable membranes from the patient until breached. Breaching one or more of the impermeable barriers increases the surface area of semi permeable membrane exposed to the patient and controllably increases the delivery rate of the pharmaceutical agent through the delivery orifice and catheter.

Abstract: Systems and methods convey a closure material into a catheter to seal a puncture site in a blood vessel. The closure material comprises a mixture of first and second components which, upon mixing, undergo a reaction to form a solid closure material composition. The systems and methods assure ease of delivery and effective mixing of the components to create an in situ barrier at the puncture site.

Abstract: An intravascular catheter system for the treatment of occluded blood vessels that includes tissue displacement or hinged expansion members that are movable from a closed to an open position. An actuating assembly may be provided for moving the tissue expansion members between an open and closed position to exert a substantially lateral distal end force upon the region surrounding an occluded blood vessel. The tissue expansion members may stretch apart, tear or otherwise disrupt a vascular occlusion sufficiently to create a pathway that may support the passage or placement of a guidewire or an interventional vascular device across the occlusion or obstruction. Methods of crossing or displacing a vascular occlusion are further provided that include the positioning of a vascular catheter having at least one hinged spreading member positioned at the distal region of the catheter that is responsive to directed force along the longitudinal axis of the catheter.

Abstract: Total occlusions are crossed by passing a guidewire or other penetrating wire from a point proximal to the occlusion into a subintimal space between the intimal layer and adventitial layer of the blood vessel wall. The wire is advanced to a point distal to the occlusion and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.

Abstract: An apparatus is described for treating arterial occlusions combining an intraluminally operable catheter, having an occlusion-crossing working element, with a micro-invasive extraluminally operable locator for imaging the progress of the working element through the occlusion. Conical, abrasive, blunt-dissecting, and sharp-pointed, and steering and non-steering working elements including guide wires are described. Acoustic transducers and a flexible imaging tube are described for the locator. A suction cup is described for removably anchoring the imaging tube to a surface. A signal-emitting working element and cooperating signal-receiving locator are described. A method for treating arterial occlusions is described.

Abstract: A guidewire or a catheter for crossing vascular occlusions comprises a shaft having a proximal end and a distal end, and a drive member having a proximal and a distal end, the drive member being rotatably disposed within and along a longitudinal axis of the guidewire shaft. An actuator is connected to the proximal end of the drive member, the actuator imparting a rotation to the drive member. An asymmetrical rotating tip is attached to the distal end of the drive member and driven in rotation about the longitudinal axis of the shaft by the drive member. The rotating tip may include a protruding portion that projects from a plane defined by an outer surface of the guidewire shaft to render the rotating tip asymmetrical with respect to the longitudinal axis of the shaft. The protruding portion creates a volume of revolution as the asymmetrical tip rotates, which facilitates crossing a vascular occlusion by displacing and exerting pressure on stenotic material causing the occlusion.

Abstract: An apparatus is described for treating arterial occlusions combining an intraluminally operable catheter having an occlusion-crossing working element, with an extraluminally operable locator for imaging the progress of the working element through the occlusion. Suction coupling means are described for removably anchoring the locator to a surface proximate the heart. A method for treating arterial occlusions is described in which the distal end of the catheter shaft exits a lumen of the locator, penetrates the arterial wall distal to the occlusion, crosses the occlusion retrograde and passes into a separately introduced standard intravascular catheter, whereupon the distal end of the shaft may be manipulated from the proximal end of the standard catheter. The proximal end of the shaft is then released from external attachments and drawn into the artery to perform treatment or guiding functions. Spatial interrelationships are observed real-time via the locator.

Abstract: Total occlusions are crossed by passing a guidewire or other penetrating wire from a point proximal to the occlusion into a subintimal space between the intimal layer and adventitial layer of the blood vessel wall. The wire is advanced to a point distal to the occlusion and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.

Abstract: Total occlusions are crossed by passing a guidewire or other penetrating wire from a point proximal to the occlusion into a subintimal space between the intimal layer and adventitial layer of the blood vessel wall. The wire is advanced to a point distal to the occlusion and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn and the guidewire is available for introduction of other interventional and diagnostic catheters.

Abstract: Methods and apparatus for crossing totally to substantially occluded blood vessels by passing a redirectable wire such as a guidewire from a relatively proximal point past the occlusion within a subintimal space formed between the intimal layer and the adventitial layer of a blood vessel wall. The wire may be advanced to a point distal to the occlusion, and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. The deflecting catheter may include a flapper valve assembly or preformed actuator wire for redirecting the guidewire. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn, and the guidewire may be available for introduction of other interventional and diagnostic catheters for performing procedures such as stenting.

Abstract: An intravascular catheter system for the treatment of occluded blood vessels that includes tissue displacement or hinged expansion members that are movable from a closed to an open position. An actuating assembly may be provided for moving the tissue expansion members between an open and closed position to exert a substantially lateral distal end force upon the region surrounding an occluded blood vessel. The tissue expansion members may stretch apart, tear or otherwise disrupt a vascular occlusion sufficiently to create a pathway that may support the passage or placement of a guidewire or an interventional vascular device across the occlusion or obstruction. Methods of crossing or displacing a vascular occlusion are further provided that include the positioning of a vascular catheter having at least one hinged spreading member positioned at the distal region of the catheter that is responsive to directed force along the longitudinal axis of the catheter.

Abstract: Methods and apparatus for crossing totally to substantially occluded blood vessels by passing a redirectable wire such as a guidewire from a relatively proximal point past the occlusion within a subintimal space formed between the intimal layer and the adventitial layer of a blood vessel wall. The wire may be advanced to a point distal to the occlusion, and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. The deflecting catheter may include a flapper valve assembly or preformed actuator wire for redirecting the guidewire. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn, and the guidewire may be available for introduction of other interventional and diagnostic catheters for performing procedures such as stenting.

Abstract: Methods and apparatus for crossing totally to substantially occluded blood vessels by passing a redirectable wire such as a guidewire from a relatively proximal point past the occlusion within a subintimal space formed between the intimal layer and the adventitial layer of a blood vessel wall. The wire may be advanced to a point distal to the occlusion, and thereafter deflected back into the blood vessel lumen, typically using a deflecting catheter which is advanced over the guidewire after it has been positioned within the subintimal space. The deflecting catheter may include a flapper valve assembly or preformed actuator wire for redirecting the guidewire. After the guidewire is returned to the blood vessel lumen, the deflecting catheter may be withdrawn, and the guidewire may be available for introduction of other interventional and diagnostic catheters for performing procedures such as stenting.