Abstract: An apparatus and method for an ultrasonic medical device to treat peripheral artery disease. 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 an insertion point in a leg opposite the leg having an occlusional deposit and is moved adjacent to the occlusional deposit. 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 occlusional deposit causing peripheral artery disease.

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: The present invention provides an apparatus and method for an ultrasonic medical device with improved visibility in imaging procedures. A medical device comprises an elongated probe having a material of high radiopacity at an at least one predetermined location of the probe wherein the material of high radiopacity is capable of withstanding series of vibrations of the elongated probe. The material of high radiopacity allows the elongated probe to be visualized in imaging procedures when the probe is inserted into a body. The present invention provides a method of improving the visibility of an ultrasonic medical device during a medical procedure by engaging a material of high radiopacity to a small diameter elongated probe wherein the material of high radiopacity engages the probe at an at least one predetermined location.

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: 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 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: 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: The present invention provides an apparatus and method for an ultrasonic medical device with improved visibility in imaging procedures. A medical device comprises an elongated probe having a material of high radiopacity at an at least one predetermined location of the probe wherein the material of high radiopacity is capable of withstanding series of vibrations of the elongated probe. The material of high radiopacity allows the elongated probe to be visualized in imaging procedures when the probe is inserted into a body. The present invention provides a method of improving the visibility of an ultrasonic medical device during a medical procedure by engaging a material of high radiopacity to a small diameter elongated probe wherein the material of high radiopacity engages the probe at an at least one predetermined location.

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 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: 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: The present invention provides an apparatus and a method for using an elongated ultrasonic probe in conjunction with a radiopaque coating in order to improve the visibility of the ultrasonic probe during a procedure such as fluoroscopy. The radiopaque coating may be an ink comprising an adhesive material. The adhesive material comprises a substance which allows for a significant amount of x-ray absorption. The present invention provides an ultrasonic device comprising an elongated probe having a small-diameter wherein the elongated probe is coated in a radiopaque coating. The present invention provides a method of improving the visibility of an ultrasonic device during a fluoroscopic procedure comprising applying a radiopaque coating to an elongated probe having a small diameter. The radiopaque coating of the present invention is capable of withstanding vibrations of the elongated probe and increases the visibility of the elongated probe in a fluoroscopic procedure.

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 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: 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: 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 transverse mode ultrasonic probe is provided which creates a cavitation area along its longitudinal length, increasing the working surface of the probe. Accessory sheaths are also provided for use with the probe to enable a user to select from features most suited to an individual medical procedure. The sheaths provide acoustic enhancing and aspiration enhancing properties, and/or can be used as surgical tools or as medical access devices, protecting tissue from physical contact with the probe.