Abstract: Methods, systems and devices are provided which promote the uptake of one or more agents into cellular material, wherein incorporation of such agent(s) improve the intended performance of the material upon implantation. This is particularly applicable to vascular replacements wherein uptake of agents, such as nucleic acids, induces long-term stable adaptation of the vascular replacement involving resistance to neointimal hyperplasia and atherosclerosis. The promotion of such uptake is achieved with the use of vibrational energy, particularly ultrasound. The cellular material is immersed into an acoustically transmissive solution comprising the agent. The immersed material is then exposed to vibrational energy under conditions and for a time which promotes incorporation of the agent into the cells. Portable, convenient and easy to use systems and devices are also provided for use in conjunction with these methods.

Abstract: Methods and systems for detecting ultrasound transducer failure in an ultrasound catheter system comprise providing a memory device or other data storage element or catheter body having at least one ultrasound transducer disposed. The memory device stores a test current amplitude value which relates to an actual operating peak current for the at least one ultrasound transducer. An average actual operating peak current amplitude during a first period of time is calculated, and an actual operating peak current for the at least one ultrasound transducer over a second period of time may optionally also be calculated. Transducer failure has occurred if the actual operating peak current amplitude passes outside of a fit preferred range during the firs period of time, or the actual operating peak current amplitude passes outside of a second preferred range during a second period of time.

Abstract: Methods and apparatus for inhibiting hyperplasia following stent placement are provided. The stents will be coated with pharmaceutical agent(s) and the methods provide for directing vibrational energy at the implanted stents or the blood vessel walls or region of implantation. The vibrational energy can have one or more of several beneficial effects. The vibrational energy may directly inhibit hyperplasia, may effect or modulate release of agent from the stent, or may enhance permeability of the blood vessel wall.

Abstract: A method for inhibiting hyperplasia at an anastomotic junction of a vascular fistula or vascular graft comprises exposing the anastomotic junction to vibrational energy at a mechanical index and for a time sufficient to inhibit hyperplasia. Kits are described comprising the catheter or a probe suitable for performing the methods together with instructions for use setting forth the methods. The methods and kits are particularly suitable for treating anastomotic junctions formed to provide vascular access for hemodialysis, hemofiltration, and the like. The methods and kits are also suitable for treating other vascular grafts, such as those formed during cardiac bypass graft surgery, vascular repair, and the like.

Abstract: The immune response achieved by the administration of nucleic acid vaccines is enhanced by the application of vibrational energy to the inoculated tissue region. The vibrational energy is selected to enhance transfection of the tissue without substantial tissue damage, relying on a mechanical effect of the vibrational energy. Additionally, vibrational energy intended to mechanically injure the tissue via a thermal effect may also be applied.

Abstract: A wide beam ultrasound delivery system providing a uniform exposure field is used to enhance the uptake of injected substances and/or to enhance the transfection of DNA in the tissues of human subject, or reduce the amount of vascular intimal hyperplasia in human subjects following vascular injury.

Abstract: A therapeutic ultrasound delivery system, comprises: a catheter body, a plurality of axially spaced-apart hollow cylindrical vibrational transducers disposed along a length of the catheter body, a first spring connector wrapped around the outer surfaces of the vibrational transducers, where the first spring connector exerting an inward pre-stress on the outer surfaces of the vibrational transducers; and a second connector disposed in contact with the inner surfaces of the vibrational transducers. The second connector may comprise a spring coil, particularly a spring coil having multiple deflection points which contact an inner surface of the cylindrical vibrational transducer.

Abstract: A wide beam ultrasound delivery system providing a uniform exposure field is used to enhance the uptake of injected substances and/or to enhance the transfection of DNA in the tissues of human subject, or reduce the amount of vascular intimal hyperplasia in human subjects following vascular injury.

Abstract: Atherosclerotic plaque and blood vessels may be stabilized by directing vibrational energy, typically ultrasonic energy, into the adjacent blood vessel wall. Application of the vibrational energy, optionally in combination with growth factors, growth factor genes, or other substances which enhance growth stability of a fibrotic cap over the plaque, will reduce the risk of rupture of unstable plaque and inhibit the conversion of stable plaque into unstable plaque.

Abstract: Post-interventional neointimal hyperplasia in arteries is treated by the application of ultrasonic energy. Usually, an intravascular catheter having an interface surface is positioned at a target site in the artery which has previously been treated. The interface surface is vibrationally excited to apply energy to the arterial wall in a manner which inhibits smooth muscle cell proliferation in the neointimal layer.

Abstract: Nucleic acid transfection of vascular smooth muscle cells is enhanced by the application of vibrational energy to the cells. By applying vibrational energy at frequency in the range from 1 kHz to 10 MHz and at an intensity in the range from 0.01 W/cm2 to 100 W/cm2, significant enhancement of the uptake of nucleic acids into vascular smooth muscle cells can be achieved.

Abstract: A method of treating a target region in a body lumen, said method comprising: directing a uniform dose of ultrasonic energy from an interior of the lumen radially outward over a treatment length of the lumen, wherein the dosage of ultrasonic energy received at any one point along the length varies by no more than plus or minus 6 decibels from that received at any other point along the length.

Abstract: A therapeutic ultrasound delivery system, comprising: a catheter body; a plurality of axially spaced-apart hollow cylindrical vibrational transducers disposed along a length of the catheter body; a first spring connector wrapped around the outer surfaces of the vibrational transducers, the first spring connector exerting an inward pre-stress on the outer surfaces of the vibrational transducers; and a second connector disposed in contact with the inner surfaces of the vibrational transducers.

Abstract: A method of enhancing cellular absorption of a substance delivered into a target region of a patient's body, comprising: (a) delivering the substance to the target region; and (b) directing vibrational energy to the target region, wherein the vibrational energy is of a type and in an amount sufficient to enhance absorption into cells of the target region.

Abstract: Post-interventional neointimal hyperplasia in arteries is treated by the application of ultrasonic energy. Usually, an intravascular catheter having an interface surface is positioned at a target site in the artery which has previously been treated. The interface surface is vibrationally excited to apply energy to the arterial wall in a manner which inhibits smooth muscle cell proliferation in the neointimal layer.

Abstract: Post-interventional neointimal hyperplasia in arteries is treated by the application of ultrasonic energy. Usually, an intravascular catheter having an interface surface is positioned at a target site in the artery which has previously been treated. The interface surface is vibrationally excited to apply energy to the arterial wall in a manner which inhibits smooth muscle cell proliferation in the neointimal layer.

Abstract: A catheter comprises a catheter body having an oscillating driver, an interface surface mechanically coupled to the driver, and an inflatable balloon disposed near the interface surface. The balloon may be an angioplasty balloon, in which case the interface surface will deliver ultrasonic or other vibratory energy into a blood vessel as part of an angioplasty or related procedure. Alternatively, the catheter may comprise a pair of axially spaced-apart isolation balloons, in which case the interface surface can deliver ultrasonic or other vibratory energy into a treatment region defined between said balloons. The energy can thus act to mix or enhance penetration of a treatment held between said balloons in performing a vascular treatment procedure.

Abstract: A catheter comprises a catheter body having an oscillating driver, an interface surface mechanically coupled to the driver, and an inflatable balloon disposed near the interface surface. The balloon may be an angioplasty balloon, in which case the interface surface will deliver ultrasonic or other vibratory energy into a blood vessel as part of an angioplasty or related procedure. Alternatively, the catheter may comprise a pair of axially spaced-apart isolation balloons, in which case the interface surface can deliver ultrasonic or other vibratory energy into a treatment region defined between said balloons. The energy can thus act to mix or enhance penetration of a treatment held between said balloons in performing a vascular treatment procedure.

Abstract: A catheter comprises a catheter body having an oscillating driver, an interface surface mechanically coupled to the driver, and an inflatable balloon disposed near the interface surface. The balloon may be an angioplasty balloon, in which case the interface surface will deliver ultrasonic or other vibratory energy into a blood vessel as part of an angioplasty or related procedure. Alternatively, the catheter may comprise a pair of axially spaced-apart isolation balloons, in which case the interface surface can deliver ultrasonic or other vibratory energy into a treatment region defined between said balloons. The energy can thus act to mix or enhance penetration of a treatment held between said balloons in performing a vascular treatment procedure.

Abstract: A method of enhancing cellular absorption of a substance delivered into a target region of a patient's body, comprising: (a) delivering the substance to the target region; and (b) directing vibrational energy to the target region, wherein the vibrational energy is of a type and in an amount sufficient to enhance absorption into cells of the target region.