# US 7,503,895 B2 · Ultrasonic device for tissue ablation and sheath for use therewith

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- Number: US 7,503,895 B2
- Document ID: US7503895B2
- Status: Granted
- Kind: B2
- Application number: 10/373,134
- Filed: 2003-02-24
- Published: 2003-09-18
- Granted: 2009-03-17
- Earliest claimed: 1999-10-05
- Assignees: OmniSonics Medical Technologies, Inc.
- Inventors: Robert A. Rabiner; Bradley A. Hare
- Web page: https://patentgrep.com/patent/US7503895B2

## CPC

- A61N 7/022: {intracavitary}
- A61B 17/22012: {in direct contact with, or very close to, the obstruction or concrement (for removing obstructions in blood vessels by laser A61B18/245)}
- A61B 17/320068: {using mechanical vibrations, e.g. ultrasonic (A61B17/22012 takes precedence; dental tooth drilling devices operated by vibration A61C3/03; removing intra-ocular material using mechanical vibrations A61F9/00745)}
- A61B 2017/00137: {Details of operation mode}
- A61B 2017/00274: {Prostate operation, e.g. prostatectomy, turp, bhp treatment}
- A61B 2017/22002: {preventing restenosis}
- A61B 2017/22007: {Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing}
- A61B 2017/22008: {used or promoted}
- A61B 2017/22015: {with details of the transmission member}
- A61B 2017/22018: {segmented along its length}
- A61B 2017/22051: {with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation (A61B2017/22048, A61B2017/3486 take precedence)}
- A61B 2017/293: {with means preventing relative rotation between the shaft and the actuating rod}
- A61B 2017/320069: {for ablating tissue}
- A61B 2017/32007: {with suction or vacuum means}
- A61B 2017/320084: {Irrigation sleeves}
- A61B 2017/320089: {node location}
- A61B 2017/320098: {with transverse or torsional motion}
- A61B 2018/00547: {Prostate}
- A61B 2018/00982: {combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes}
- A61B 2217/005: with suction drainage system
- A61B 2217/007: with irrigation system
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- A61N 2007/0008: {Destruction of fat cells}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## 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.

## Claims

### Claim 1

An ultrasonic medical device for tissue ablation comprising:
an elongated probe having a proximal end, a distal end and at least two regions of differing cross sectional dimension, wherein a length of the elongated probe is configured to oscillate in a direction transverse to a longitudinal axis of the elongated probe to emit transverse ultrasonic energy along the length of the elongated probe so that a plurality of transverse nodes and transverse anti-nodes are formed along the length of the elongated probe; and
a sheath assembly at least partially surrounding the elongated probe, the sheath assembly comprising at least one sheath defining a fenestration between a proximal and distal end of the at least one sheath, the at least one sheath being configured to substantially dampen ultrasonic energy such that ultrasonic energy delivered by the elongated probe is focused toward a region adjacent the fenestration.

### Claim 2 (depends on 1)

The device of claim 1, wherein the sheath assembly covers at least a portion of the elongated probe, the sheath assembly comprising a longitudinally extending structural wall that defines a longitudinally extending hollow interior for accommodating at least a portion of the elongated probe, wherein the longitudinally extending structural wall of the sheath assembly is substantially self supporting so that the longitudinally extending structural wall substantially maintains a same shape with the elongated probe disposed in the longitudinally extending hollow interior as without the elongated probe disposed in the longitudinally extending hollow interior.

### Claim 3 (depends on 1)

The device of claim 1, wherein the sheath assembly is constructed to substantially prevent a transmission of cavitational energy generated by the elongated probe to a surrounding environment.

### Claim 4 (depends on 1)

The device of claim 1, wherein the sheath assembly further comprises one or more devices capable of manipulating a tissue.

### Claim 5 (depends on 1)

The device of claim 1, wherein the sheath assembly further comprises at least one reflective element configured to reflect ultrasonic energy.

### Claim 6 (depends on 1)

The device of claim 1, wherein the sheath assembly further comprises at least one irrigation channel.

### Claim 7 (depends on 1)

The device of claim 1, wherein the sheath assembly further comprises at least one aspiration channel.

### Claim 8 (depends on 1)

The device of claim 1, wherein the sheath assembly further comprises at least one channel for delivering a therapeutic agent therethrough.

### Claim 9 (depends on 1)

The device of claim 1, wherein the sheath assembly is adapted for use with an imaging system.

### Claim 10

A method of modulating, focusing and directing a cavitational energy emitted from an ultrasonic probe vibrating in a direction transverse to a longitudinal axis of the ultrasonic probe for tissue ablation comprising:
enclosing at least a portion of the ultrasonic probe within a sheath assembly comprising a sheath defining at least one fenestration between a proximal end and a distal end of the sheath;
inserting the ultrasonic probe into a blood vessel;
guiding the ultrasonic probe and the sheath assembly into the blood vessel and to a site of an occlusion;
positioning the ultrasonic probe and the sheath assembly such that the at least one fenestration is in proximity with the occlusion;
providing an ultrasonic excitation signal to the ultrasonic medical device and transferring the ultrasonic excitation signal along a length of the ultrasonic probe to a flexible probe tip, thereby causing a transverse vibration of the length of the ultrasonic probe and the flexible probe tip and a generation of a plurality of transverse nodes and anti-nodes of the cavitational energy along the length of the ultrasonic probe and the flexible probe tip; and
controlling a selective transmission of cavitational energy through the at least one fenestration in the sheath, thereby directing the cavitational energy in an area of the occlusion within the blood vessel to cause fragmentation of the occlusion.

### Claim 11 (depends on 10)

The method of claim 10, wherein the sheath assembly is capable of partially shielding tissue at a site of a surgical procedure from the ultrasonic probe.

### Claim 12 (depends on 10)

The method of claim 10, further comprising removing at least one fragment of the occlusion through an aspiration conduit of the sheath assembly.

### Claim 13 (depends on 10)

The method of claim 10, further comprising supplying an irrigating fluid to the site of the occlusion through an irrigation conduit of the sheath assembly.

### Claim 14 (depends on 10)

The method of claim 10, further comprising delivering a therapeutic agent through a conduit of the sheath assembly.

### Claim 15 (depends on 10)

The method of claim 10, further comprising positioning the ultrasonic probe proximal to the occlusion using an imaging system.

### Claim 16 (depends on 10)

The method of claim 10, comprising manipulating tissue with a tissue manipulation device of the sheath assembly.

### Claim 17 (depends on 10)

The method of claim 10, further comprising shielding an ultrasound energy emitted from the ultrasonic probe with the sheath assembly, and visualizing a surgical site with an ultrasound imaging system, the shielding of the ultrasound energy increasing the resolution of the surgical site visualized by the ultrasound imaging system.

### Claim 18 (depends on 10)

The method of claim 10, further comprising introducing the sheath assembly from an exterior of a patient to the site of the occlusion, and introducing the ultrasonic probe into the sheath assembly and guiding the ultrasonic probe to a surgical site.

### Claim 19

A medical device, comprising:
an ultrasonic probe configured to emit ultrasonic energy transversely along a portion of the ultrasonic probe; and
a sheath comprising a proximal end and a distal end, the sheath at least partially surrounding the ultrasonic probe and defining a fenestration between the proximal and distal ends of the sheath, the sheath being configured to substantially dampen ultrasonic energy such that ultrasonic energy delivered by the medical device is focused toward a region adjacent the fenestration.

### Claim 20 (depends on 19)

The medical device of claim 19, wherein the sheath defines a plurality of fenestrations between the proximal and distal ends of the sheath.

### Claim 21 (depends on 19)

The medical device of claim 19, wherein the fenestration extends from a proximal end of the sheath to a distal end of the sheath.

### Claim 22 (depends on 19)

The medical device of claim 19, further comprising at least one reflective element disposed on an interior surface of the sheath.

### Claim 23 (depends on 19)

The medical device of claim 19, wherein the sheath is at least partially surrounded by a second, retractable sheath.

### Claim 24 (depends on 19)

The medical device of claim 19, wherein the sheath is constructed to substantially prevent ultrasonic energy from passing therethrough.

### Claim 25 (depends on 24)

The medical device of claim 24, wherein the sheath comprises one or more materials that are capable of dissipating ultrasonic energy.