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

• US 6,432,067 B1
• Filed: 09/03/1999
• Issued: 08/13/2002
• Est. Priority Date: 10/31/1997
• Status: Expired due to Term

• Current Assignee: Sonic Concepts, Inc.
• Original Assignee: Sonic Concepts, Inc., University of Washington
• Inventors: Martin, Roy W., Crum, Lawrence A., Kaczkowski, Peter J., Carter, Stephen J., Keilman, George, Proctor, Andrew, Helton, W. Scott, Gaps, Michael, Vaezy, Shahram
• Primary Examiner(s): Smith, Ruth S.
• Application Number:
  US09/390,032
• Time in Patent Office: 1,075 Days
• Field of Search: 601/2-4, 600/439, 600/454, 600/411, 600/427, 600/447, 600/457, 600/455, 600/371, 600/459, 600/461, 606/111
• US Class Current: 601/2
• 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 by marking A61B2090/395
• 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 method for causing hemostasis, the method comprising:

surgically baring a hemorrhaging blood vessel or hemorrhaging parenchyma; and

subjecting said blood vessel or parenchyma to direct input sonic energy comprising high intensity focused ultrasound such that said hemorrhaging blood vessel or parenchyma is cauterized by said sonic energy.

2. The method as set forth in claim 1, the subjecting further comprising:

applying said high intensity focused ultrasound energy having a frequency in the approximate range of 0.5 MHZ to 20 MHz.

3. The method as set forth in claim 1 further comprising:

controlling energy level and duration of exposure to cause closure of fibrous sheath tissue surrounding the breach of the hemorrhaging vessel without substantially damaging wall tissue of the vessel itself.

4. A method for causing hemostasis in an open and visible hemorrhage, the method comprising:

using a transducer means, having an ultrasonic transducer having a transmitting surface emitting high frequency focused ultrasound having a frequency in the approximate range of 0.5 MHZ to 20 MHz and a depth of focus substantially immediately adjacent said transducer means, applying high intensity focused ultrasound energy directly onto outer regions of a hemorrhaging vessel adjacent to a vascular breach; and

controlling energy level and duration of exposure to cause closure of fibrous sheath tissue surrounding the breach of the hemorrhaging vessel without substantially damaging wall tissue of the vessel itself.

5. A method for causing hemostasis of an internal hemorrhage, the method comprising:

surgically exposing a blood vessel or parenchyma source of said hemorrhage; and

directly subjecting the tissue of said source of said hemorrhage to sonic energy comprising high intensity focused ultrasound such that said hemorrhaging blood vessel or parenchyma is cauterized by said sonic energy.

6. The method as set forth in claim 5, the subjecting further comprising:

closing a shunt or other internal bleeding using said sonic energy without affecting or cutting through adjacent tissue.

7. The method as set forth in claim 6, the exposing further comprising:

occluding a blood vessel feeding the shunt, the shunt itself, or the vessel receiving shunt blood flow.

8. The method as set forth in claim 6, the step of exposing further comprising the step of:

coagulating a specific volume of tissue encompassing a whole tissue region or malformation of a blood vessel feeding the shunt, the shunt, and the vessel receiving the shunt.

9. The method as set forth in claim 5 further comprising:

controlling energy level and duration of exposure to cause closure of fibrous sheath tissue surrounding the breach of the hemorrhaging vessel without substantially damaging wall tissue of the vessel itself.