Methods of tonsil reduction using high intensity focused ultrasound to form an ablated tissue area containing a plurality of lesions

• US 6,451,013 B1
• Filed: 07/31/2000
• Issued: 09/17/2002
• Est. Priority Date: 01/19/2000
• Status: Expired due to Term

• Current Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Xomed Incorporated (Medtronic Plc)
• Inventors: Bays, F. Barry, Hissong, James B.
• Primary Examiner(s): Dvorak, Linda C. M.
• Assistant Examiner(s): Ruddy, David M.
• Application Number:
  US09/629,842
• Time in Patent Office: 778 Days
• Field of Search: 601/2-4, 604/21-22, 604/114, 606/27-32, 606/34, 606/38, 606/41, 606/42, 606/46, 606/49, 606/48, 606/50, 606/52, 606/101, 606/102, 606/96, 606/97, 606/134, 128/898
• US Class Current: 606/27
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/02 Localised ultrasound hyperthermia hyperthermia in general A61F7/00

Abstract

A method of tonsil reduction by thermal ablation using high intensity focused ultrasound energy includes the steps of introducing an ultrasound emitting member in a patient'"'"'s oral cavity, positioning the ultrasound emitting member adjacent an external surface of one of the patient'"'"'s tonsils, emitting ultrasound energy from the ultrasound emitting member into the tissue of the one tonsil, focusing the ultrasound energy in the one tonsil, ablating the tissue of the one tonsil with the focused ultrasound energy to form an ablated tissue area in the one tonsil containing unablated tissue of the one tonsil and a plurality of lesions at which the tissue of the one tonsil is ablated, and withdrawing the ultrasound emitting member from the oral cavity. The ablated tissue area is surgically removed or is allowed to remain in the patient'"'"'s body. The lesions may be absorbed by the patient'"'"'s body and/or remain as altered tissue such that the tonsil is reduced in size to correspondingly increase the size of the patient'"'"'s airway and/or is stiffened to resist vibration. The lesions can begin a predetermined distance beneath the external surface of the tonsil such that the mucosa is preserved. The lesions end at a predetermined depth so that muscular tissue is not damaged.

Claims

1. A method of thermal ablation of a tonsil comprising the steps of

introducing an ultrasound emitting member in a patient'"'"'s oral cavity;

positioning the ultrasound emitting member adjacent an external tissue surface of one of the patient'"'"'s tonsils;

emitting ultrasound energy from the ultrasound emitting member into the tissue of the one tonsil;

focusing the ultrasound energy at a plurality of focusing zones contained in a target area in the one tonsil;

heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy to form an ablated tissue area at the target area containing unablated tissue of the one tonsil and a plurality of lesions at the focusing zones, respectively, at which the tissue of the one tonsil is ablated;

withdrawing the ultrasound emitting member from the oral cavity; and

allowing the lesions to be absorbed by the patient'"'"'s body so that the one tonsil is reduced in physical size.

2. The method of thermal ablation of a tonsil as recited in claim 1 wherein said step of focusing includes focusing the ultrasound energy in a target area disposed beneath the external tissue surface.

3. The method of thermal ablation of a tonsil as recited in claim 2 wherein said step of heating includes heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy to achieve a temperature in the range of 60 to 100 degrees Celsius.

4. The method of thermal ablation of a tonsil as recited in claim 3 wherein said step of heating includes heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy so that the lesions begin at a beginning margin located below the external tissue surface of the one tonsil.

5. The method of thermal ablation of a tonsil as recited in claim 4 wherein said step of heating includes heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy so that the lesions begin at a beginning margin located 1 to 4 mm below the external tissue surface of the one tonsil.

6. The method of thermal ablation of a tonsil as recited in claim 5 wherein said step of heating includes heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy so that the lesions end at an ending margin located 4 to 12 mm below the external tissue surface of the one tonsil.

7. The method of thermal ablation of a tonsil as recited in claim 6 wherein said step of heating includes heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy for a duration in the range of 2 to 60 seconds.

8. The method of thermal ablation of a tonsil as recited in claim 1 wherein said step of heating includes forming the ablated tissue area surrounded by unablated tissue of the one tonsil.

10. The method of thermal ablation of a tonsil as recited in claim 8 wherein said step of heating includes forming the ablated tissue area so that at least one of the plurality of lesions contacts another of the plurality of lesions.

9. A method of thermal ablation of a tonsil comprising the steps of

introducing an ultrasound emitting member in a patient'"'"'s oral cavity;

positioning the ultrasound emitting member adjacent an external tissue surface of one of the patient'"'"'s tonsils;

emitting ultrasound energy from the ultrasound emitting member into the tissue of the one tonsil;

focusing the ultrasound energy at a plurality of focusing zones contained in a target area in the one tonsil;

heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy to form an ablated tissue area at the target area containing unablated tissue of the one tonsil and a plurality of lesions at the focusing zones, respectively, at which the tissue of the one tonsil is ablated, said step of heating including forming the ablated tissue area surrounded by unablated tissue of the one tonsil, said step of heating including forming the ablated tissue area so that the plurality of lesions do not contact one another; and

withdrawing the ultrasound emitting member from the oral cavity.

11. A method of thermal ablation of a tonsil comprising the steps of

introducing an ultrasound emitting member in a patient'"'"'s oral cavity;

positioning the ultrasound emitting member adjacent an external tissue surface of one of the patient'"'"'s tonsils;

emitting ultrasound energy from a plurality of ultrasound emitting elements of the ultrasound emitting member;

focusing the ultrasound energy in the one tonsil at a plurality of spaced focusing zones corresponding to the ultrasound emitting elements, respectively;

ablating the tissue of the one tonsil with the focused ultrasound energy to form an ablated tissue area containing unablated tissue of the one tonsil and a plurality of lesions at the focusing zones, respectively, at which the tissue of the one tonsil is ablated;

withdrawing the ultrasound emitting member from the oral cavity; and

allowing the lesions to be replaced with scar tissue so that the one tonsil is rendered more resistant to vibration.

12. The method of thermal ablation of a tonsil as recited in claim 11 wherein said step of ablating includes forming the plurality of lesions to begin at a beginning margin located below the external tissue surface of the one tonsil, to end at an ending margin located further below the external tissue surface of the one tonsil than the beginning margin and to have a depth between the beginning and ending margins in the range of 1.0 to 11.0 mm.

13. The method of thermal ablation of a tonsil as recited in claim 12 wherein said step of ablating includes forming the plurality of lesions to begin at a beginning margin located about 2 mm below the external tissue surface of the one tonsil.

14. The method of thermal ablation of a tonsil as recited in claim 13 wherein said step of ablating includes forming the plurality of lesions to end at an ending margin located about 8 mm below the external tissue surface of the one tonsil.

15. The method of thermal ablation of a tonsil as recited in claim 11 wherein said step of ablating includes forming the ablated tissue area with a cross-sectional length in the range of 2 to 20 mm.

16. The method of thermal ablation of a tonsil as recited in claim 15 wherein said step of ablating includes forming the ablated tissue area with a cross-sectional width of 2 to 20 mm.

17. A method of tonsil reduction comprising the steps of

introducing an ultrasound emitting member in a patient'"'"'s oral cavity;

positioning the ultrasound emitting member adjacent an external tissue surface of one of the patient'"'"'s tonsils;

emitting ultrasound energy from a plurality of ultrasound emitting elements of the ultrasound emitting member;

focusing the ultrasound energy in the one tonsil at a plurality of spaced focusing zones corresponding to the ultrasound emitting elements, respectively;

ablating the tissue of the one tonsil with the focused ultrasound energy to form an ablated tissue area containing unablated tissue of the one tonsil and a plurality of lesions at the focusing zones, respectively, at which the tissue of the one tonsil is ablated, said step of ablating including forming the plurality of lesions to begin at a beginning margin coincident with the external tissue surface of the one tonsil and to end at an ending margin located below the external tissue surface of the one tonsil;

withdrawing the ultrasound emitting member from the oral cavity; and

surgically removing the ablated tissue area.

18. A method of thermal ablation of a tonsil comprising the steps of

introducing an ultrasound emitting member in a patient'"'"'s oral cavity;

positioning the ultrasound emitting member adjacent the mucosa of one of the tonsils of the patient;

actuating selected ones of a plurality of ultrasound emitting elements of the ultrasound emitting member to emit ultrasound energy;

emitting ultrasound energy from the selected ultrasound emitting elements into the one tonsil;

focusing the ultrasound energy in the one tonsil at a plurality of spaced focusing zones corresponding to the selected ultrasound emitting elements, respectively;

ablating the tissue of the one tonsil with the focused ultrasound energy to form an ablated tissue area containing unablated tissue of the one tonsil and a plurality of lesions at the focusing zones, respectively, at which the tissue of the one tonsil is ablated;

withdrawing the ultrasound emitting member from the oral cavity; and

allowing the lesions to be replaced with scar tissue so that the stiffness of the one tonsil is increased.

20. The method of thermal ablation of a tonsil as recited in claim 18 and further including, prior to said step of actuating, the step of selecting the ultrasound emitting elements to be actuated.

21. The method of thermal ablation of a tonsil as recited in claim 18 wherein said step of focusing includes focusing the ultrasound energy at a plurality of focusing zones disposed below the mucosa.

22. The method of thermal ablation of a tonsil as recited in claim 18 wherein said step of ablating includes forming the plurality of lesions beneath the mucosa.

19. A method of thermal ablation of a tonsil comprising the steps of

introducing an ultrasound emitting member in a patient'"'"'s oral cavity;

positioning the ultrasound emitting member adjacent the mucosa of one of the tonsils of the patient;

actuating selected ones of a plurality of ultrasound emitting elements of the ultrasound emitting member to emit ultrasound energy;

emitting ultrasound energy from the selected ultrasound emitting elements into the one tonsil;

focusing the ultrasound energy in the one tonsil at a plurality of spaced focusing zones corresponding to the selected ultrasound emitting elements, respectively;

ablating the tissue of the one tonsil with the focused ultrasound energy to form an ablated tissue area containing unablated tissue of the one tonsil and a plurality of lesions at the focusing zones, respectively, at which the tissue of the one tonsil is ablated, said step of ablating including forming the ablated tissue area in substantially the entire one tonsil;

withdrawing the ultrasound emitting member from the oral cavity; and

surgically removing the ablated tissue area to thereby remove the entire one tonsil without the capsule thereof.

23. A method of thermal ablation of a tonsil comprising the steps of

introducing an ultrasound emitting member in a patient'"'"'s oral cavity;

positioning the ultrasound emitting member adjacent an external tissue surface of one of the patient'"'"'s tonsils;

emitting ultrasound energy from the ultrasound emitting member into the tissue of the one tonsil;

focusing the ultrasound energy at a plurality of focusing zones contained in a target area in the one tonsil;

heating the tissue of the one tonsil at the focusing zones with the focused ultrasound energy to form an ablated tissue area at the target area containing unablated tissue of the one tonsil and a plurality of lesions at the focusing zones, respectively, at which the tissue of the one tonsil is ablated;

withdrawing the ultrasound emitting member from the oral cavity; and

allowing the ablated tissue area to remain in the patient'"'"'s body so that the one tonsil is rendered more resistant to germs.