Flowcardia, Inc.

C. R. Bard, Inc.

Other

Jeff Sarge

Henry Nita

Simon Nguyen

Martinos Tran

Richard Samuel Spano

Michael A Summers

Simeon Nguyen

A method for making a vibrational catheter device includes providing a transition connector comprising a proximal portion, a distal portion, and a tapered portion that defines a tapered outer surface of the transition connector, the proximal portion being wider than the distal portion, and the transition connector having a bore disposed within the tapered portion; inserting a proximal end of an ultrasound transmission member into the bore; and deforming at least part of the transition connector at the tapered outer surface so as to apply greater force to the wider proximal portion than to the distal portion to secure the proximal end of the ultrasound transmission member within the bore.

Vibrational catheter devices and methods for making same

A method of recanalizing a lumen of a vessel includes positioning an ultrasonic device having a distal end in a first position within the lumen of the vessel; transmitting pulsed ultrasonic vibrations though the ultrasonic device to the distal end; and advancing the distal end through the lumen to recanalize the vessel.

Ultrasound catheter system

A method for operating an ultrasonic reentry device, includes: providing an ultrasound transmission member having a proximal end and a distal end; providing a catheter body having a lumen surrounding the ultrasound transmission member; providing a dilator slidably disposed within the lumen of the catheter body, the dilator surrounding the ultrasound transmission member; and exposing the distal end of the ultrasound transmission member from a distal end of the dilator.

Vascular re-entry device

A catheter includes a catheter body (CB) having a CB proximal-portion, a CB distal-portion, and a CB lumen. The CB distal-portion has a CB distal end. The CB proximal-portion has a distally narrowing taper, wherein the CB distal-portion extends distally from the distally narrowing taper of the CB proximal-portion. The CB lumen extends through the CB proximal-portion and the CB distal-portion. An ultrasound transmission member (UTM) has a UTM distal end. The UTM extends longitudinally through the CB lumen. The UTM has a longitudinal taper that tapers toward the UTM distal end, and wherein the longitudinal taper tapers distally from the distally narrowing taper of the CB proximal-portion. A distal head (DH) is coupled with the UTM distal end and is disposed adjacent the CB distal end.

Steerable ultrasound catheter

An ultrasound catheter includes a catheter body, an ultrasound transmission member, a sonic connector, a constraining member, and a vibrational absorber. The vibrational absorber has an opening through which the ultrasonic transmission member extends. The vibrational absorber is located in a recessed portion of the constraining member. The vibrational absorber is both longitudinally interposed between the constraining member and the distal portion of the sonic connector and laterally interposed between the recessed portion of the constraining member and the ultrasound transmission member. The recessed portion of the constraining member overlaps a portion of an exterior of the distal portion of the sonic connector.

Ultrasound catheter apparatus

A method of operating an ultrasound catheter includes providing an elongate catheter body having at least a first lumen; providing a housing coupled with a proximal end of the elongate catheter body, the housing having an inner cavity; providing a fluid inlet in fluid communication with at least one of the first lumen and the inner cavity; providing a sonic connector coupled to a proximal portion of an ultrasound transmission member; providing vibration absorption O-rings disposed in the inner cavity around at least a portion of the ultrasound transmission member, the plurality of vibration absorption O-rings being located distal to the sonic connector; and delivering fluid to the fluid inlet to supply the fluid at least distally into the first lumen of the elongate catheter body to dissipate heat received from the ultrasound transmission member in the first lumen of the elongate catheter body.

Ultrasound catheter devices and methods

An ultrasonic catheter includes a body and an ultrasound transmission member disposed in the body. A head is coupled to the ultrasound transmission member, wherein a gap separates the head from a body distal end. A guidewire tube extends through the body and the head. A proximal end connector assembly includes a hub and an absorber member. The hub has a bore coupled to and in fluid communication with the body. The absorber member is disposed within the bore around the ultrasound transmission member. A sonic connector is disposed between the ultrasound transmission member and a separate generator.

Ultrasound catheter for disrupting blood vessel obstructions

An ultrasonic device having a tri-axial configuration including an ultrasound transmission member, a dilator, and a sheath is disclosed. The ultrasound device may be used in a procedure to treat an occluded blood vessel. The ultrasound transmission member can transmit ultrasonic energy from an ultrasonic transmission member into the subintimal space of a blood vessel. The sheath may articulate to aid in the process of re-entering the central lumen of the blood vessel.

Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Ultrasound catheter devices generally include an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and a distal head coupled with the transmission member and positioned adjacent the distal end of the catheter body for disrupting occlusions. Improved features of ultrasound catheters include catheter bodies and ultrasound transmission members with increasing distal flexibility, guidewire tubes allowing contact between a guidewire and an ultrasound transmission member, distal heads with improved guidewire lumens, and torquable proximal housings for enhancing disruption of blood vessel occlusions.

A vibrational catheter for disrupting obstructions in lumens such as blood vessels includes an elongate flexible catheter body having a proximal end, a distal end and at least one lumen extending longitudinally therethrough, a vibrational transmission member extending longitudinally through the lumen of the catheter body and having a proximal end and a distal end, and a transition connector attached to the proximal end of the vibrational transmission member for coupling the transmission member with a vibrational energy source. The transition connector includes a bore into which the proximal end of the vibrational transmission member extends. The proximal end of the vibrational transmission member is attached within the bore of the transition connector with variable attachment forces such that the transition connector exerts a lowest amount of attachment force on an attached distal-most portion of the vibrational transmission member housed within the bore.

An ultrasonic system operable at high drive frequencies and/or in pulsed operation is disclosed. The system may be used in a procedure to treat an occluded blood vessel. The system can be used to transmit ultrasonic energy from an ultrasonic transducer to a distal end of an ultrasonic transmission device. The ultrasonic device may operate at a resonant frequency. The resonant frequency can be determined prior to using the device and/or during use. The ultrasonic device may operate in a range of frequencies at or near resonance. Operational parameters including, for example, reflected vibrations, temperature, and/or user input can be used by the system to adjust the driving waveform.

Ultrasound catheter devices and methods of the present invention generally provide for ablation and/or disruption of vascular occlusions. An ultrasound transmission member, such as a wire, transmits vibrational energy from an ultrasound transducer to a distal head of the catheter to disrupt vascular occlusions. An absorber member is disposed on or around the ultrasound transmission wire at a location adjacent the sonic connector of the catheter. The absorber member absorbs heat, vibrations, and/or the like from the ultrasound transmission wire at or near the area where the transmission wire is coupled with the sonic connector. The absorptive function typically slows the process of wear and tear on the transmission wire, thus extending the useful life of the ultrasound catheter.

Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Generally, an ultrasound catheter device includes an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and a distal head coupled with the transmission member and positioned adjacent the distal end of the catheter body for disrupting occlusions. A proximal housing of the catheter device may include one or more features for dissipating heat from the ultrasound transmission wire, such as a fluid inlet aperture for passage of fluid, use of heat conductive materials in the proximal housing, surface features to increase the housing's surface area, heat conductive members disposed adjacent the transmission member and the like. Various irrigation fluids may be used, such as cooled, oxygen supersaturated or lubricious fluids.

Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Generally, an ultrasound catheter includes an elongate flexible catheter body with one or more lumens. An ultrasound transmission member or wire extends longitudinally through the catheter body lumen and, in many embodiments, a guide wire tube also extends through the same lumen. A distal head is fixed to or otherwise mechanically coupled with the distal end of the ultrasound transmission member or wire and is positioned adjacent the distal end of the catheter body. Although the distal end of the catheter body overlaps the distal head, the distal head is not directly affixed to the distal end of the catheter body. Thus, the distal tip may move freely, relative to the distal end of the catheter body when ultrasonic energy is applied through the ultrasound transmission member. Such a freely floating distal head enhances the efficiency of an ultrasound catheter, enabling the catheter to ablate calcific occlusions and increasing the useful life of the ultrasound transmission member and catheter.

An ultrasonic device having a tri-axial configuration including an ultrasound transmission member, a dilator, and a sheath is disclosed. The ultrasound device may be used in a procedure to treat an occluded blood vessel. The ultrasound transmission member can transmit ultrasonic energy from an ultrasonic transducer to a distal end. The dilator facilitates entry of the ultrasonic transmission member into the subintimal space of a blood vessel. The sheath may articulate to aid in the process of re-entering the central lumen of the blood vessel.

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Fremont, CA, United States of America

Jeff Sarge