Abstract: The present invention provides an apparatus and method for a torque limiting wrench used for applying a torque to a medical device to prevent damage to the medical device by providing a predetermined torque limit to indicate when the predetermined torque is reached. The torque limiting wrench comprises a gripping mechanism for engaging a medical device, a handle extending from the gripping mechanism and a torque limiting assembly contained within a length of the handle. A predetermined torque is set by the torque limiting assembly to provide an indicator to prevent damage to the acoustic characteristics of the medical device. The torque limiting wrench comprises a material that can undergo a sterilization process.

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: 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 flexible heating cover assembly for an apparatus for heating samples of biological material with substantial temperature uniformity includes a housing having a plurality of engageable enclosure components; a resistive heater having a plurality of heater element areas; a heater backing plate providing stability to the resistive heater; a force distribution system that distributes a force over the heater backing plate; and a support plate providing stiffness for the force distribution system, wherein the arrangement of the resistive heater, the heater backing plate, the force distribution system and the support plate provide substantial temperature uniformity among a plurality of sample tubes for receiving samples of biological material. The flexible heating cover assembly improves the uniformity, efficiency, quality, reliability and controllability of the thermal response during thermal cycling of the biological material.

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: 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 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 apparatus for thermally cycling samples of a biological material including a thermal block assembly including a plurality of sample holders for receiving samples of biological material; a heat sink thermally coupled to the thermal block assembly, the heat sink transferring heat away from the thermal block assembly to ambient air in contact with the heat sink; a first heat source thermally coupled to the thermal block assembly to provide heat to the thermal block assembly; and a second heat source thermally coupled to the first heat source and configured to provide heat to a portion of the first heat source. The arrangement of the heat sink, first heat source and second heat source can provide substantial temperature uniformity among the plurality of sample holders. The invention also includes a method for thermally cycling samples of biological material.

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.