Abstract: The present invention provides an apparatus and a method for an ultrasonic medical device having a flexible material engaging an ultrasonic probe. The flexible material surrounds a portion of a longitudinal axis of an ultrasonic probe of the ultrasonic medical device. The flexible material may extend beyond a probe tip. The flexible material cushions a tip of the ultrasonic probe and reduces the stresses on the ultrasonic probe as the ultrasonic probe is navigated within the vasculature. The ultrasonic probe may be shaped to increase a radial span of the ultrasonic medical device. In a preferred embodiment of the present invention, the flexible material comprises a polymer material. Additionally, the flexible material may have a high radiopacity.

Abstract: A handle includes a body portion and a handle portion which is slidably and rotatably mounted on the body portion. Shoulders on the body portion and the handle portion limit relative sliding movement of the body portion and handle portion. A catheter open at both ends has one end fixed to the handle portion for movement therewith, the opposite end of the catheter having a shape memory tip. A fitting is threadedly connected to an enlarged part of the body portion. A sheath is threadedly connected to the fitting and the catheter is slidable and rotatable within the sheath. An annular channel is provided between the sheath and the catheter, this channel being in fluid communication with a bore in the fitting. The outer end of the sheath has holes therethrough in fluid communication with the channel. An irrigation inflow and aspiration outflow tube is also in fluid communication with the bore in the fitting.

Abstract: The present invention provides an apparatus and a method for an ultrasonic medical device with a non-compliant balloon used to ablate a biological material. The ultrasonic medical device comprises an ultrasonic probe, a catheter surrounding the ultrasonic probe, a balloon supported by the catheter and an inflation lumen located along a longitudinal axis of the catheter. The ultrasonic probe is inserted into a vasculature and the catheter comprising the balloon is advanced until the balloon is adjacent to the biological material. The balloon is inflated until at least a portion of an outer surface of the balloon engages the biological material. The ultrasonic probe is energized to produce a transverse ultrasonic vibration that vibrates at least a portion of the balloon to ablate the biological material into a particulate.

Abstract: The present invention provides an apparatus and a method for using a preshaped ultrasonic probe to ablate an occlusion in a vasculature. An ultrasonic medical device comprising an ultrasonic probe having a proximal end, a distal end and a longitudinal axis therebetween and a preshaped segment along the longitudinal axis increases a surface area of the ultrasonic probe in communication with the occlusion. A method of increasing a treatment area of an ultrasonic probe to ablate an occlusion comprising inserting the ultrasonic probe with a preshaped segment into a catheter, advancing the preshaped segment beyond a distal end of the catheter and activating an ultrasonic energy source to provide an ultrasonic energy to the ultrasonic probe to ablate the occlusion. The present invention increases the surface area in communication with the occlusion, maximizes a radial span in a vasculature and expands a treatment area of the ultrasonic probe.

Abstract: A handle includes a body portion and a handle portion which is slidably and rotatably mounted on the body portion. Shoulders on the body portion and the handle portion limit relative sliding movement of the body portion and handle portion. A catheter open at both ends has one end fixed to the handle portion for movement therewith, the opposite end of the catheter having a shape memory tip. A fitting is threadedly connected to an enlarged part of the body portion. A sheath is threadedly connected to the fitting and the catheter is slidable and rotatable within the sheath. An annular channel is provided between the sheath and the catheter, this channel being in fluid communication with a bore in the fitting. The outer end of the sheath has holes therethrough in fluid communication with the channel. An irrigation inflow and aspiration outflow tube is also in fluid communication with the bore in the fitting.

Abstract: The present invention provides an apparatus and a method of using an ultrasonic probe with a pharmacological agent to enhance an occlusion treating effect of the ultrasonic probe to effectively remove an occlusion. The pharmacological agent is released through a catheter to treat the occlusion and enhance an effect of a transverse ultrasonic vibration of the ultrasonic probe to effectively remove the occlusion. The pharmacological agent continues to travel downstream of the site of the occlusion and work in conjunction with the ultrasonic probe to reduce the occlusion to a size that can easily be removed from the body naturally in order to prevent reformation of the occlusion and other health risks.

Abstract: An apparatus and method for an ultrasonic medical device to treat deep vein thrombosis. The ultrasonic medical device comprises an ultrasonic probe having a proximal end, a distal end and a longitudinal axis therebetween. The ultrasonic probe is inserted into a deep vein of a leg, navigated adjacent to a thrombus in the deep vein and placed in communication with the thrombus. An ultrasonic energy source is activated to generate a transverse ultrasonic vibration along at least a portion of the longitudinal axis of the ultrasonic probe. The transverse ultrasonic vibration creates a plurality of transverse nodes and a plurality of transverse anti-nodes along the longitudinal axis of the ultrasonic probe, generating cavitation in a medium surrounding the ultrasonic probe to ablate the thrombus and treat deep vein thrombosis.

Abstract: A method for destructing, reducing or removing mammalian tissue with an ultrasonic device is disclosed, comprising contacting the tissue with a transverse mode ultrasonic probe, and transmitting ultrasonic energy to the probe, until the tissue is fragmented by emulsification. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion and in combination with an imaging device to effect remodeling of human tissue in medical and cosmetic surgical procedures.

Abstract: An ultrasonic tissue ablation device comprising a transversely vibrating elongated probe, and a coupling assembly for probe attachment and detachment that enables the probe assembly and separation from the device body that includes the ultrasound energy source and a sound conductor, and a method of use for removal of vascular occlusions in blood vessels. The coupling assembly enables incorporation of elongated probes with small cross sectional lumens such as a catheter guidewires. The probe detachability allows insertion manipulation and withdrawal independently of the device body. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion. The horn assembly of the device that contains a sound conducting horn functions as an energy regulator and reservoir for the probe, and precludes loss of probe cavitation energy by its bending or damping within the blood vessel.

Abstract: A handle includes a body portion and a handle portion which is slidably and rotatably mounted on the body portion. Shoulders on the body portion and the handle portion limit relative sliding movement of the body portion and handle portion. A catheter open at both ends has one end fixed to the handle portion for movement therewith, the opposite end of the catheter having a shape memory tip. A fitting is threadedly connected to an enlarged part of the body portion. A sheath is threadedly connected to the fitting and the catheter is slidable and rotatable within the sheath. An annular channel is provided between the sheath and the catheter, this channel being in fluid communication with a bore in the fitting. The outer end of the sheath has holes therethrough in fluid communication with the channel. An irrigation inflow and aspiration outflow tube is also in fluid communication with the bore in the fitting.

Abstract: A method for removing an occlusion is provided comprising introducing a transverse mode ultrasonic probe into a blood vessel, positioning the probe in proximity to the occlusion, and transmitting ultrasonic energy to the probe, until the occlusion is removed. The probe has a small cross-sectional lumen and is articulable for navigating in a tortuous vessel path. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion. The probe can also be used with a balloon catheter. The probe, sheaths, and catheter can be provided in a sharps container which further provides a means of affixing and detaching the probe from an ultrasonic medical device.

Abstract: The present invention provides an apparatus and a method of using an ultrasonic probe with a pharmacological agent to enhance an occlusion treating effect of the ultrasonic probe to effectively remove an occlusion. The pharmacological agent is released through a catheter to treat the occlusion and enhance an effect of a transverse ultrasonic vibration of the ultrasonic probe to effectively remove the occlusion. The pharmacological agent continues to travel downstream of the site of the occlusion and work in conjunction with the ultrasonic probe to reduce the occlusion to a size that can easily be removed from the body naturally in order to prevent reformation of the occlusion and other health risks.

Abstract: A method and apparatus for removing plaque, fatty deposits, and other occlusions from blood vessels using ultrasonic energy. The method and apparatus has particular application in removing plaque from the carotid artery in a non-thermal manner. The apparatus is designed to have as small a cross-sectional profile as possible, therefore allowing the apparatus to be used in a minimally-invasive manner. As a result, the apparatus can be used in both surgical and outpatient treatment with minimal post-operative complications and minimal damage to areas other than the area of treatment. An ultrasonic probe may include aspiration channels on its outer surface. An aspiration sheath may surround the ultrasonic probe, such that the location of an aspiration port may be varied axially relative to the ultrasonic tip.

Abstract: An ultrasonic tissue ablation device comprising a transversely vibrating elongated probe, and a coupling assembly for probe attachment detachment that enables the probe assembly and separation from the device body that includes the ultrasound energy source and a sound conductor, and a method of use for removal of vascular occlusions in blood vessels. The coupling assembly enables incorporation of elongated probes with small cross sectional lumens such as a catheter guidewires. The probe detachability allows insertion manipulation and withdrawal independently of the device body. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion. The horn assembly of the device that contains a sound conducting horn functions as an energy regulator and reservoir for the probe, and precludes loss of probe cavitation energy by its bending or damping within the blood vessel.

Abstract: A method for destructing, reducing or removing mammalian tissue with an ultrasonic device IS disclosed, comprising contacting the tissue with a transverse mode ultrasonic probe, and transmitting ultrasonic energy to the probe, until the tissue is fragmented by emulsification. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion and in combination with an imaging device to effect remodeling of human tissue in medical and cosmetic surgical procedures.

Abstract: An apparatus and method for manufacturing small diameter ultrasonic probes capable of vibrating in a transverse mode that can be used in ultrasonic tissue ablation. The apparatus includes a die, a style puller which is used to engage a functional end of the medical device, and a die room puller which is used to draw the medical device through the die. The die includes a bell-shaped lead-in on a front side of the die and a bell-shaped lead-in on a back side of the die allowing for reversal of the direction of the draw. The method of manufacturing includes heat treating a large diameter medical device, drawing the large diameter device through a die and reversing the draw of the medical device through the die to provide a medical device having a varying diameter along a length of the device. The method is repeated until a final diameter is reached.

Abstract: A handle includes a body portion and a handle portion which is slidably and rotatably mounted on the body portion. Shoulders on the body portion and the handle portion limit relative sliding movement of the body portion and handle portion. A catheter open at both ends has one end fixed to the handle portion for movement therewith, the opposite end of the catheter having a shape memory tip. A fitting is threadedly connected to an enlarged part of the body portion. A sheath is threadedly connected to the fitting and the catheter is slidable and rotatable within the sheath. An annular channel is provided between the sheath and the catheter, this channel being in fluid communication with a bore in the fitting. The outer end of the sheath has holes therethrough in fluid communication with the channel. An irrigation inflow and aspiration outflow tube is also in fluid communication with the bore in the fitting.

Abstract: The present invention provides an apparatus and a method for using an ultrasonic probe to remove an occlusion in vascular access devices including fistulas, grafts, catheters and subcutaneous access devices. The ultrasonic probe is inserted into the vascular access device and a section of a longitudinal axis of the ultrasonic probe engages the occlusion. A transducer transmits an ultrasonic energy from an ultrasonic energy source that produces a transverse ultrasonic vibration along the longitudinal axis of the ultrasonic probe. The transverse ultrasonic vibration of the ultrasonic probe provides a plurality of transverse anti-nodes along a portion of the longitudinal axis of the ultrasonic probe that cause a cavitation in a medium in communication with the ultrasonic probe to ablate the occlusion.

Abstract: A method and apparatus for removing plaque, fatty deposits, and other occlusions from blood vessels using ultrasonic energy. The method and apparatus has particular application in removing plaque from the carotid artery in a non-thermal manner. The apparatus is designed to have as small a cross-sectional profile as possible, therefore allowing the apparatus to be used in a minimally-invasive manner. As a result, the apparatus can be used in both surgical and outpatient treatment with minimal post-operative complications and minimal damage to areas other than the area of treatment. An ultrasonic probe may include aspiration channels on its outer surface. An aspiration sheath may surround the ultrasonic probe, such that the location of an aspiration port may be varied axially relative to the ultrasonic tip.

Abstract: A method for removing an occlusion is provided comprising introducing a transverse mode ultrasonic probe into a blood vessel, positioning the probe in proximity to the occlusion, and transmitting ultrasonic energy to the probe, until the occlusion is removed. The probe has a small cross-sectional lumen and is articulable for navigating in a tortuous vessel path. The probe can be used with acoustic and/or aspirations sheaths to enhance destruction and removal of an occlusion. The probe can also be used with a balloon catheter. The probe, sheaths, and catheter can be provided in a sharps container which further provides a means of affixing and detaching the probe from an ultrasonic medical device.