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

• US 20030018255A1
• Filed: 06/13/2002
• Published: 01/23/2003
• Est. Priority Date: 10/31/1997
• Status: Abandoned Application

• Current Assignee: Andrew Proctor, George Keilman, Helton W. Scott, Lawrence A. Crum, Michael Gaps, Peter J. Kaczkowski, Roy W. Martin, Shahram Vaezy, Stephen J. Carter
• Original Assignee: Andrew Proctor, George Keilman, Helton W. Scott, Lawrence A. Crum, Michael Gaps, Peter J. Kaczkowski, Roy W. Martin, Shahram Vaezy, Stephen J. Carter
• Inventors: Martin, Roy W., Crum, Lawrence A., Carter, Stephen J., Proctor, Andrew, Helton, W. Scott, Gaps, Michael, Vaezy, Shahram, Kaczkowski, Peter J., Keilman, George
• Application Number:
  US10/171,149
• Publication Number:
  US 20030018255A1
• Time in Patent Office: Days
• US Class Current: 600/437
• 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.

17. The method as set forth in claim 16, the step of exposing further comprising the step of:

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

20. The device as set forth in claim 19, further comprising:

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

21. The device as set forth in claim 20, 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.

22. The device as set forth in claim 20, said tissue backing means further comprising:

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

23. The device as set forth in claim 19, 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.

24. The device as set forth in claim 19, 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 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 a 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.

25. The device as set forth in claim 24, 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.

26. The device as set forth in claim 25, 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.

27. The device as set forth in claim 25, 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.

16. A method for causing hemostasis comprising the steps of:

baring a hemorrhaging blood vessel or parenchyma; and

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

18. A method for causing hemostasis in a visible hemorrhaging wound, comprising the steps of:

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 onto outer regions of a hemorrhaging vessel adjacent to a vascular breach; and

controlling energy level and the 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.

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

a 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.

28. 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.

29. A high intensity focused ultrasound medical instrument for use with an electronic controller means, the instrument comprising:

a pencil-like handle;

fixedly mounted on a tip of the handle, sealed acoustic coupling means for interfacing ultrasonic energy into a patient;

mounted subjacent the acoustic coupling means, ultrasound transducer means, including at least one transducer for emitting ultrasonic energy through the acoustic coupling means such that a focal region is produced immediately adjacent the acoustic coupling means; and

incorporated through the handle, means for coupling the transducer means to the electronic controller.

30. A high intensity focused ultrasound medical instrument for use with an electronic controller means, the instrument comprising:

a palm-of-the-hand shaped and dimensioned handle;

fixedly mounted on a first surface of the handle, sealed acoustic coupling means for interfacing ultrasonic energy into a patient;

mounted on a second surface of the handle subjacent the acoustic coupling means, ultrasound transducer means, including at least one transducer for emitting sonic energy through the acoustic coupling means; and

mounted on a third surface of the handle opposing the first surface, means for coupling the transducer means to the electronic controller.

31. The instrument as set forth in claim 30, said transducer means further comprising:

at least one imaging transducer;

at least one high intensity focused ultrasonic transducer means for emitting ultrasonic energy through said acoustic coupling means in a frequency in an approximate range of 0.5 MHZ to 20 MHz.

32. The instrument as set forth in claim 31, said high intensity focused ultrasonic transducer means further comprising:

a plurality of transducers forming a discretely targetable set of ultrasonic emitters.

33. The instrument as set forth in claim 31, said high intensity focused ultrasonic transducer means further comprising:

an annular array transducer system.

35. The method as set forth in claim 34, the step of exposing further comprising the step of:

closing a shunt or other internal bleeding without affecting or cutting through adjacent tissue.

36. The method as set forth in claim 35, the step of exposing further comprising the step of:

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

37. The method as set forth in claim 35, 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.

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

without surgical incision, exposing a blood vessel or parenchyma 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.