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 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: 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.

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: 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 medical device such as an endoscope has an elongated flexible sheath. A first sleeve has a passage there through which snugly receives the sheath, the first sheath being slideable from its proximal end to its distal end. The sleeve is a thin-walled tube having a constant inner diameter so as to minimize the increase the outer dimension of the device at the portion upon which the sleeve is positioned. The sleeve has a length of approximately one-half the length of the sheath and may have greater stiffness than the sheath. A second sleeve may be slideably mounted on the first sleeve and has a snug fit therewith. The second sleeve is also a thin-walled tube having a constant outer dimension. The second sleeve has a length of approximately one-half the length of the first sleeve and may have greater stiffness than the first sleeve.

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.

Abstract: The invention is directed to a container for storage, dispensation, transport and disposal of a medical device such a disposable ultrasonic surgical probe, that allows its dispensation for use, and for its safe storage and disposal after use, thereby protecting the user from the hazards of needle pricks and possible contamination from small-diameter probes. The container of the present invention also provides a mechanism for restricting access to the probe to prevent its reuse, and a method for its safe attachment to and detachment from an ultrasonic medical device. The container comprises a cylindrical tube having two ends and an inner surface defining a space for containing the probe.

Abstract: An ultrasonic medical device comprises an ultrasonic vibration generator that generates vibration along its longitudinal axis. The ultrasonic vibration is transmitted through an ultrasonic coupler and a series of transformer sections that amplify the ultrasonic vibration. A flexible member is coupled to the distal end of the transformer sections, and is thus supplied with a longitudinal vibration at its base by the transformer sections. The flexible member is designed so that it converts the longitudinal vibration into a standing wave that runs along the length of the flexible member. The standing wave produces a series of nodes and anti-nodes along the length of the flexible member. Each of the anti-nodes produces cavitation in fluids in contact with the probe. The cavitation of the fluids causes destruction of adjacent tissue. In this manner, the entire length of the flexible member becomes a working surface that may be utilized for destroying tissue.

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 medical device such as an endoscope has an elongated flexible sheath. A first sleeve has a passage there through which snugly receives the sheath, the first sheath being slide-able from its proximal end to its distal end. The sleeve is a thin-walled tube having a constant inner diameter so as to minimize the increase the outer dimension of the device at the portion upon which the sleeve is positioned. The sleeve has a length of approximately one-half the length of the sheath and may have greater stiffness than the sheath. A second sleeve may be slide-ably mounted on the first sleeve and has a snug fit therewith. The second sleeve is also a thin-walled tube having a constant outer dimension. The second sleeve has a length of approximately one-half the length of the first sleeve and may have greater stiffness than the first sleeve.

Abstract: An ultrasonic medical device comprises an ultrasonic vibration generator that generates vibration along its longitudinal axis. The ultrasonic vibration is transmitted through an ultrasonic coupler and a series of transformer sections that amplify the ultrasonic vibration. A flexible member is coupled to the distal end of the transformer sections, and is thus supplied with a longitudinal vibration at its base by the transformer sections. The flexible member is designed so that it converts the longitudinal vibration into a standing wave that runs along the length of the flexible member. The standing wave produces a series of nodes and anti-nodes along the length of the flexible member. Each of the anti-nodes produces cavitation in fluids in contact with the probe. The cavitation of the fluids causes destruction of adjacent tissue. In this manner, the entire length of the flexible member becomes a working surface that may be utilized for destroying tissue.

Abstract: An ultrasonic medical device comprising an ultrasonic probe and a collet assembly for probe attachment and detachment, and a method of removing occlusions in blood vessels using the ultrasonic medical device. The probe detachability allows insertion, manipulation and withdrawal independently of a device body. The collet assembly comprises a compression clamp capable of releasably receiving the probe, and a compression housing that initiates a minimal area “line-contact” between the collet assembly segments upon engagement. A line-contact lip ensures consistent and repeatable contact between the compression clamp and the compression housing at a predetermined location to provide a consistent closing force on the probe for any selected tightening torque. The line-contact between the collet assembly segments provides efficient ultrasonic energy transfer from an ultrasonic energy source to the probe thereby increasing the probe efficiency during tissue ablation.