Method and apparatus for medical procedures using high-intensity focused ultrasound

• US 6,315,741 B1
• Filed: 09/03/1999
• Issued: 11/13/2001
• Est. Priority Date: 10/31/1997
• Status: Expired due to Term

• Current Assignee: Sonic Concepts, Inc.
• Original Assignee: Sonic Concepts, Inc.
• Inventors: Vaezy, Shahram, Martin, Roy W., Crum, Lawrence A., Kaczkowski, Peter J., Carter, Stephen J., Proctor, Andrew, Helton, W. Scott, Gaps, Michael, Keilman, George
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US09/390,506
• Time in Patent Office: 802 Days
• Field of Search: 301/2-4, 600/439, 600/454, 600/411, 600/427, 600/447, 600/457, 600/455, 600/459, 600/461, 600/371
• US Class Current: 601/3
• CPC Class Codes: A61B 17/22004 using mechanical vibrations, e.g. ultrasonic shock waves A61B17/225 takes precedence
• CPC Class Codes: A61B 17/2251 characterised by coupling elements between the apparatus, e.g. shock wave apparatus or locating means, and the patient, e.g. details of bags, pressure control of bag on patient
• CPC Class Codes: A61B 17/2255 Means for positioning patient, shock wave apparatus or locating means, e.g. mechanical aspects, patient beds, support arms, aiming means positioning of patients for radiation diagnosis A61B6/04; positioning of locating means inside shock wave apparatus A61B17/2256
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2017/22008 used or promoted
• CPC Class Codes: A61B 2017/320052 Guides for cutting instruments
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/320071 with articulating means for working tip
• CPC Class Codes: A61B 2017/320082 for incising tissue
• CPC Class Codes: A61B 2017/320095 with sealing or cauterizing means
• CPC Class Codes: A61B 2090/0472 against ultrasound energy
• CPC Class Codes: A61B 8/14 Echo-tomography
• CPC Class Codes: A61B 8/4209 by using holders, e.g. positioning frames
• CPC Class Codes: A61B 8/4218 characterised by articulated arms
• CPC Class Codes: A61B 8/4254 using sensors mounted on the probe
• CPC Class Codes: A61B 8/4281 characterised by sound-transmitting media or devices for coupling the transducer to the tissue
• CPC Class Codes: A61B 8/4461 Features of the scanning mechanism, e.g. for moving the transducer within the housing of the probe
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61N 2007/0065 Concave transducers
• CPC Class Codes: A61N 2007/0069 Reflectors
• CPC Class Codes: A61N 2007/0078 : with multiple treatment transducers
• CPC Class Codes: A61N 2007/0091 : with moving parts, e.g. transducers, lenses, reflectors
• CPC Class Codes: A61N 2007/027 : with multiple foci created simultaneously
• CPC Class Codes: A61N 7/02 : Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

Methods and apparatus for enabling substantially bloodless surgery and for stemming hemorrhaging. High intensity focused ultrasound (“HIFU”) is used to form cauterized tissue regions prior to surgical incision, for example, forming a cauterized tissue shell around a tumor to be removed. The procedure is referred to as “presurgical volume cauterization.” In one embodiment, the method is particularly effective for use in surgical lesion removal or resection of tissue having a highly vascularized constitution, such as the liver or spleen, and thus a propensity for hemorrhaging. In further embodiments, methods and apparatus for hemostasis using HIFU is useful in both surgical, presurgical, and medical emergency situations. In an apparatus embodiment, a telescoping, acoustic coupler is provided such that depth of focus of the HIFU energy is controllable. In other embodiments, apparatus characterized by portability are demonstrated, useful for emergency medical situations.

Claims

1. A presurgical device for preparing an organ of a patient for surgical incisions, comprising:

transducer means for emitting energy as high frequency focused ultrasound; and

means for controlling focal position and focal intensity of energy emissions from said transducer means such that acoustic energy at selective focal zones produces coagulative necrosed tissue in the form of predetermined surgical pathways within the tissue such that surgical incisions along the surgical pathways is subject to substantially no bleeding; and

tissue backing means for protecting tissue beyond a selective focal zone from exposure effects of emitted energy from the transducer means.

2. The device as set forth in claim 1, said tissue backing means further comprising:

an acoustic energy absorber having an acoustic impedance approximately equal to acoustic impedance of the tissue at the frequency of the emitted energy and a thickness and thermal properties such that abutting the tissue does not become heated by said absorber.

3. The device as set forth in claim 1, said tissue backing means further comprising:

means for reflecting said emitted energy back to said focal zone.

4. The device as set forth in claim 1, further comprising:

said transducer means emits high intensity focused ultrasound energy having a depth of focus and depth of field in respective ranges in combination with said means for controlling such that the device provides cauterization of visible hemorrhaging.

5. The device as set forth in claim 1, said transducer means further comprises:

said transducer means having at least one surface for emitting acoustic energy having a frequency in the range of 0.5 MHZ to 20 MHz; and

mounted to said transducer means, means for acoustically coupling said energy to the tissue, including a liquid-filled chamber mounted proximate said surface and having an acoustic energy window at a position distal from said surface and means for varying gap distance from said surface to said window such that depth of said selective focal zone position changes as said gap distance is increased and decreased using said means for varying gap distance.

6. The device as set forth in claim 5, wherein said means for acoustically coupling further comprises:

a telescoping construct having a fully retracted position providing a shallow tissue penetration depth of focus, a fully extended position providing a predetermined deep tissue penetration depth of focus, and providing a substantially continuous range of depth of focus positions between said shallow tissue penetration depth of focus and said deep tissue penetration depth of focus.

7. The device as set forth in claim 6, said telescoping construct further comprising:

first means for mounting a high intensity focused ultrasound transducer and for providing an acoustic coupling medium chamber adjacent the transducer; and

second means for mounting an acoustic window for focusing ultrasound energy emitted by said transducer, wherein said second means is coupled to said first means by a screw-type interface such that a gap between said transducer and said acoustic window is variable such that depth of focus of the ultrasound energy is selected by using said screw-type interface to vary the gap.

8. The device as set forth in claim 6, said telescoping construct further comprising:

first means for mounting a high intensity focused ultrasound transducer and for providing an acoustic coupling medium chamber adjacent the transducer; and

second means for mounting an acoustic window for focusing ultrasound energy emitted by said transducer, wherein said second means is coupled to said first means by a bellows-type interface such that a gap between said transducer and said acoustic window is variable such that depth of focus of the ultrasound energy is selected by using said bellows-type interface to vary the gap.