Abstract: Interventional catheters are disclosed for use in performing diagnostic and therapeutic procedures in vessels that are accessed retrograde to blood flow. The catheters include an elongated shaft slidably disposed within a sheath, a distal region having an end effector and a filter disposed proximal to the end effector to capture emboli liberated during the diagnostic or therapeutic procedure. The filter includes a plurality of struts that cooperate with an exterior surface of the catheter to define a reservoir to retain captured emboli, the reservoir configured so that advancement of the sheath contracts the filter without squeezing or dislodging captured emboli beyond a distal end of the filter.

Abstract: The present invention provides and apparatus and methods for emboli removal and stenting within the renal arteries having a catheter system having a distal occlusion element, a stent deployment section, and an emboli removal lumen. The occlusion element is disposed at a predetermined distance from the stent deployment section specific for use in the renal artery, and is constructed to reduce the potential for perforation or jailing during stent deployment. The apparatus further includes an array of radio-opaque markers disposed on the stent delivery catheter to facilitate accurate stent deployment within a renal artery.

Abstract: Methods and apparatus are provided for treating an injured or severed nerve pathway, wherein one or more microporous tubes are implanted into the nerve pathway to bridge the injured or severed region. A bioactive matrix including stem cells and nutrients is disposed within the microporous tube to facilitate growth of the stem cells and reestablishment of the sensory and motor conductive pathways through the injured or severed region. The microporous tube protects the bioactive matrix during development of the stem cells, and also retains the end regions in proper alignment during the nerve pathway regeneration.

Abstract: Embodiments of the present invention provide apparatus and methods for embolic filtering during percutaneous valve replacement and repair procedures. Under one aspect, an apparatus comprises a sheath and a filter. The sheath has proximal and distal ends and a lumen therebetween. The distal end may be introduced into the aortic arch via the peripheral arteries and ascending aorta, while the proximal end may be disposed outside of the body. The lumen permits percutaneous aortic valve replacement or repair therethrough. The filter has a frame with an inlet and an outlet and an emboli-filtering mesh attached to the frame. The inlet is substantially spans the aortic arch in a region between the aortic valve and the great arteries. The outlet is coupled to the distal end of the sheath without leaving any gaps through which emboli could pass and without obstructing the lumen at the distal end of the sheath.

Abstract: Embodiments of the present invention provide apparatus and methods for embolic filtering during percutaneous valve replacement and repair procedures. Under one aspect, an apparatus comprises a sheath and a filter. The sheath has proximal and distal ends and a lumen therebetween. The distal end may be introduced into the aortic arch via the peripheral arteries and ascending aorta, while the proximal end may be disposed outside of the body. The lumen permits percutaneous aortic valve replacement or repair therethrough. The filter has a frame with an inlet and an outlet and an emboli-filtering mesh attached to the frame. The inlet is substantially spans the aortic arch in a region between the aortic valve and the great arteries. The outlet couples to the distal end of the sheath without leaving any gaps through which emboli could pass and without obstructing the lumen at the distal end of the sheath.

Abstract: Some embodiments relate to a catheter system having a changeable or adjustable working length. The catheter system can comprise a proximal end, a distal end, and a first axial lumen configured to receive a guidewire formed through at least a portion of the catheter body. A first opening can be formed through a portion of the catheter body and be in communication with the first lumen. The sheath can be rotatable, axially movable, or otherwise changeable from at least a first position to a second position, wherein the sheath can substantially cover the first opening in the catheter body in the first position, and can substantially expose the first opening in the catheter body in the second position.

Abstract: Methods and apparatus are provided for delivering a bioactive agent in a needle track formed in a target tissue mass, following formation of the needle track, by avoiding impingement of the agent against target tissue at high velocity or by using capillary action to draw the bioactive agent out of the needle during needle withdrawal. The apparatus comprises a catheter and a needle disposed within the catheter and configured to be selectively extended into the tissue mass to a predetermined depth, while dispensing the agent simultaneously with retraction of the needle along the needle track. Alternatively, or in addition, the needle may be configured to create a tissue space surrounding a distal or lateral surface of the needle, into which the bioactive agent to be infused.

Abstract: Interventional catheters are disclosed for use in performing diagnostic and therapeutic procedures in vessels that are accessed retrograde to blood flow. The catheters include an elongated shaft slidably disposed within a sheath, a distal region having an end effector and a filter disposed proximal to the end effector to capture emboli liberated during the diagnostic or therapeutic procedure. The filter includes a plurality of struts that cooperate with an exterior surface of the catheter to define a reservoir to retain captured emboli, the reservoir configured so that advancement of the sheath contracts the filter without squeezing or dislodging captured emboli beyond a distal end of the filter.

Abstract: A dilatation catheter for delivering a therapeutic agent within a body lumen having a wall with a thickness is provided having a balloon having a flexible wall including a polymer with dispersed nanotubes and pores configured to close below a predefined pressure and to open at or above a predefined pressure. In some embodiments, an actuator is provided to controllably inflate the balloon with a fluid at a pressure sufficient to bring the flexible wall of the balloon into contact with at least a portion of the wall of the body lumen but below the predefined pressure, and to controllably increase the pressure of the fluid within the inflated balloon to at least the predefined pressure at a rate and with a force sufficient to deliver the therapeutic agent from the pores and through at least a portion of the thickness of the wall of the body lumen.

Abstract: Apparatus and methods are provided for treating an infracted region of myocardium following acute myocardial infarction by reducing the rate of blood flow through infracted region, and then injecting a solution containing stem cells, endothelial progenitor cells or mediators of stem cell mobilization, migration and attachment into the effected region so that the stem cells become embedded therein and promote tissue regeneration. In a first embodiment, delivery of the stem cells, endothelial progenitor cells or mediators of stem cell mobilization, migration and attachment is accomplished using a catheter that relies upon antegrade flow through the coronary artery and a flow control catheter placed in the coronary sinus. In an alternative embodiment, the delivery catheter delivers the stem cells in a retrograde manner through the coronary sinus, and the delivery catheter further comprises an occlusion balloon for controlling outflow through the coronary sinus ostium.

Abstract: The present invention is directed to bistable cells and their use in devices, particularly medical devices such as stents, clamps and valves. An expandable stent formed of a plurality of bistable cells is described. The stent has two or more stable configurations, including a first stable configuration with a first diameter and a second stable configuration with a second, larger diameter. A valve comprising a bistable cell for use in eliminating incontinence is also disclosed.

Abstract: Methods and apparatus are provided for treating damaged tissue using apparatus that atraumatically delivers a bioactive agent within the tissue, wherein the apparatus provides a column of stem cells may be advanced simultaneously with a needle during needle insertion, and then held stationary or injected at low pressure while retracting the needle. Alternatively, the needle may employ electromotive forces, or to change a dimension of the needle, to expel the bioactive agent into the needle track.

Abstract: Methods and apparatus are provided for treating an injured or severed nerve pathway, wherein one or more microporous tubes are implanted into the nerve pathway to bridge the injured or severed region. A bioactive matrix including stem cells and nutrients is disposed within the microporous tube to facilitate growth of the stem cells and reestablishment of the sensory and motor conductive pathways through the injured or severed region. The microporous tube protects the bioactive matrix during development of the stem cells, and also retains the end regions in proper alignment during the nerve pathway regeneration.

Abstract: Interventional catheters are disclosed for use in performing diagnostic and therapeutic procedures in vessels that are accessed retrograde to blood flow. The catheters include an elongated shaft slidably disposed within a sheath, a distal region having an end effector and a filter disposed proximal to the end effector to capture emboli liberated during the diagnostic or therapeutic procedure. The filter includes a plurality of struts that cooperate with an exterior surface of the catheter to define a reservoir to retain captured emboli, the reservoir configured so that advancement of the sheath contracts the filter without squeezing or dislodging captured emboli beyond a distal end of the filter.

Abstract: Some embodiments relate to a catheter system having a changeable or adjustable working length. The catheter system can comprise a proximal end, a distal end, and a first axial lumen configured to receive a guidewire formed through at least a portion of the catheter body. A first opening can be formed through a portion of the catheter body and be in communication with the first lumen. The sheath can be rotatable, axially movable, or otherwise changeable from at least a first position to a second position, wherein the sheath can substantially cover the first opening in the catheter body in the first position, and can substantially expose the first opening in the catheter body in the second position.

Abstract: The present invention is directed to bistable cells and their use in devices, particularly medical devices such as stents, clamps and valves. An expandable stent formed of a plurality of bistable cells is described. The stent has two or more stable configurations, including a first stable configuration with a first diameter and a second stable configuration with a second, larger diameter. A valve comprising a bistable cell for use in eliminating incontinence is also disclosed.

Abstract: Some embodiments relate to a catheter system having a changeable or adjustable working length. The catheter system can comprise a proximal end, a distal end, and a first axial lumen configured to receive a guidewire formed through at least a portion of the catheter body. A first opening can be formed through a portion of the catheter body and be in communication with the first lumen. The sheath can be rotatable, axially movable, or otherwise changeable from at least a first position to a second position, wherein the sheath can substantially cover the first opening in the catheter body in the first position, and can substantially expose the first opening in the catheter body in the second position.

Abstract: The present invention is directed to bistable cells and their use in devices, particularly medical devices such as stents, clamps and valves. An expandable stent formed of a plurality of bistable cells is described. The stent has two or more stable configurations, including a first stable configuration with a first diameter and a second stable configuration with a second, larger diameter. A valve comprising a bistable cell for use in eliminating incontinence is also disclosed.

Abstract: Methods and apparatus are provided for delivering drugs or gene therapy within a patient's vessel. In a preferred embodiment, the apparatus comprises a material eluting a bioactive substance held in place within the patient's vessel by an anchor. The anchor and eluting material are sized and/or collapsible from a delivery configuration, in which the anchor and material may be delivered into the patient's vasculature within a delivery sheath, to a deployed configuration, wherein the anchor engages an interior wall of the patient's vessel. The eluting material may elute recombinant genes, drugs, or any other bioactive substance.