Use of focused ultrasound for vascular sealing

Abstract

An ultrasonic applicator unit (2) is used diagnostically to locate a puncture wound (316) in an artery and then therapeutically to seal the puncture wound with high intensity focused ultrasound (HIFU). A control unit (6) coupled to the applicator unit includes a processor (74) that automates the procedure, controlling various parameters of the diagnostic and therapeutic modes, including the intensity and duration of the ultrasonic energy emitted by the applicator unit. A protective, sterile acoustic shell (4), which is intended to be used with a single patient and then discarded, is slipped over the applicator unit to protect against direct contact between the applicator unit and the patient and to maintain a sterile field at the site of the puncture. The apparatus and method are particularly applicable to sealing a puncture made when inserting a catheter into an artery or other vessel. Several different procedures are described for locating the puncture wound, including imaging the vessel in which the puncture is disposed and use of a locator rod to determine the disposition of the puncture along the longitudinal axis of the artery.

Description

[0001] RELATED APPLICATIONS [0002] This application is a continuation of co-pending U.S. application Ser. No. 10 / 616,831, filed Jul. 10, 2003, which is a continuation of U.S. application Ser. No. 09 / 696,076, filed Oct. 25, 2000, now U.S. Pat. No. 6,656,136, which claims the benefit of U.S. provisional patent application, Ser. No. 60 / 163,466, filed Oct. 25, 1999, and U.S. provisional patent application, Ser. No. 60 / 171,703, filed Dec. 23, 1999.FIELD OF THE INVENTION [0003] The present invention generally relates to methods and apparatus for sealing vascular punctures and wounds, and more particularly, to a device that may be used to deliver ultrasound energy to a vascular puncture site to arrest bleeding. BACKGROUND OF THE INVENTION [0004] Various surgical procedures are performed by medical specialists such as cardiologists and radiologists, utilizing percutaneous entry into a blood vessel. To facilitate cardiovascular procedures, a small gauge needle is introduced through the skin ...

AI Technical Summary

Benefits of technology

[0013] In accord with the present invention, a method and apparatus are defined that provide advantageous solutions to the problem of expeditiously and safely sealing vascular catheter entry wounds made in connection with medical procedures. The method includes the steps of determining a site of the puncture in the vascular vessel and positioning an ultrasonic transducer applicator at a position adjacent to the site. The ultrasonic transducer applicator is coupled to a control that includes a processor pro...

Problems solved by technology

When applied manually, the procedure is time-consuming and requires the presence of a medical professional for thirty minutes or more.

For both manual and mechanical pressure application, the procedure is uncomfortable for the patient and frequently requires the administration of analgesics to be tolerable.

Moreover, the application of excessive pressure can occlude the underlying artery, resulting in ischemia and/or thrombosis.

Renewed bleeding through the tissue tract is not uncommon and can result in hematoma, pseudoaneurisms, and arteriovenous fistulas.

The risk of these complications increases with the use of larger sheath sizes, which are frequently necessary in interven...

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