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

• US 6,007,499 A
• Filed: 10/31/1997
• Issued: 12/28/1999
• Est. Priority Date: 10/31/1997
• Status: Expired due to Term

• Current Assignee: Sonic Concepts, Inc.
• Original Assignee: University of Washington
• Inventors: Proctor, Andrew, Helton, W. Scott, Vaezy, Shahram, Martin, Roy W., Crum, Lawrence A., Kaczkowski, Peter J., Carter, Stephen J., Keilman, George, Gaps, Michael
• Primary Examiner(s): Casler, Brian L.
• Application Number:
  US08/961,972
• Time in Patent Office: 788 Days
• Field of Search: 601/2-4, 600/439, 600/454, 600/411, 600/427, 600/447, 600/457, 600/455, 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 method of performing surgery with minimized bleeding, comprising the steps of:

a) determining each path of incision to be made in a tissue volume;

b) cauterizing each path using ultrasonic energy to form at least one surgical pathway in the tissue volume prior to incising; and

c) making surgical incisions only along a surgical pathway formed in accordance with step b).

2. The method as set forth in claim 1, the step of cauterizing further comprising the step of:

isolating a region of tissue from the blood supply to the region.

3. The method as set forth in claim 1, the step of cauterizing further comprising the step of:

encapsulating a volume of tissue with an encasement of coagulative necrosed tissue.

4. The method as set forth in claim 1, the step of cauterizing further comprising the step of:

surrounding a tissue volume to be surgically excised with a coagulated necrotized surface of tissue having a predetermined thickness.

5. The method as set forth in claim 1, said step of cauterizing further comprising the step of:

using high intensity focused ultrasound energy at a level sufficient to produce coagulation and necrosis in the tissue along each pathway.

6. The method as set forth in claim 1, said step of cauterizing further comprising the step of:

applying ultrasonic energy having a frequency in the range of 0.5 MHZ to 20 MHz.

7. The method as set forth in claim 1, said step of cauterizing further comprising the steps of:

A) determining a first point on an edge of a plane of a path to be cut;

B) focusing the energy to have a first focal point at the first point;

C) moving the first focal point to follow the edge of the plane, producing a first line of coagulation having a cross-sectional width;

D) refocusing the energy to have a second focal point aligned with the first line and proximate to the first point;

E) moving the second focal point to follow the plane of the path to be cut, producing a second line of coagulation along said plane; and

F) repeating said steps of refocusing and moving until the plane for incision is substantially entirely coagulated.

8. The method as set forth in claim 7, further comprising the steps of:

repeating steps A) through F) for each path of incision.

9. The method as set forth in claim 7, said step of cauterizing further comprising the step of:

applying ultras sonic energy causing a temperature gradient at each focal point in a range of approximately 59°

C. to approximately 99°

C.

10. The method as set forth in claim 7, said step of cauterizing further comprising the step of:

applying ultrasonic energy causing an intensity of acoustic radiation at each focal point in a range of approximately 1000 W/Cm² to approximately 3000 W/Cm².

11. A method for presurgical treatment of highly vascularized organic tissue to minimize bleeding during surgical procedures, the method comprising the steps of:

determining each path of incision to be made in the tissue; and

exposing each path to high intensity focused ultrasound energy having a predetermined frequency for a time period sufficient to form at least one coagulative necrosed pathway in the tissue such that making subsequent surgical incisions only along a coagulative necrosed pathway is subject to minimized bleeding.

12. The method as set forth in claim 11, further comprising the steps of:

determining each path of incision necessary to remove a volume of tissue including a lesion from the tissue; and

surrounding the volume of tissue to be surgically excised with a coagulated necrotized surface having a predetermined thickness permitting surgical incisions there through.

13. The method as set forth in claim 11, further comprising the steps of:

determining each path of incision necessary to resection the tissue; and

prior to incising the tissue, cauterizing each path using high frequency focused ultrasound energy to form at least one coagulative necrosed pathway in the tissue such that making surgical incisions only along a coagulative necrosed pathway minimizes bleeding.

14. The method as set forth in claim 11, further comprising the step of:

applying ultrasound energy having a frequency in the range of 0.5 MHZ to 20 MHz.

15. The method as set forth in claim 11, the step of exposing further comprising:

the ultrasonic energy causing an intensity of acoustic radiation at each focal point in a range of approximately 1000 W/cm² to approximately 3000 W/cm² for a duration of time such that hyper-thermic effects or a combination of hyper-thermic effects and cavitation effects are produced in the tissue.

16. A method of using high intensity focused ultrasound for surgical procedures, comprising the steps of:

prior to incising tissue of a surgery patient, applying ultrasonic energy at a combination of frequency, time of exposure, and power intensity to cause controlled coagulation and necrotization of tissue in the patient such that a volume cauterized tissue region is formed in said tissue at predetermined locations within said tissue that are to be cut.