Method for treatment of sleep apnea by ventral only ablation of the tongue

• US 10,433,901 B2
• Filed: 01/27/2017
• Issued: 10/08/2019
• Est. Priority Date: 08/31/2012
• Status: Active Grant

• Current Assignee: David G. Dillard
• Original Assignee: David G. Dillard
• Inventors: Dillard, David G.
• Primary Examiner(s): Summitt, Lynnsy M
• Assistant Examiner(s): Carter, Tara Rose E
• Application Number:
  US15/417,461
• Publication Number:
  US 20170135755A1
• Time in Patent Office: 984 Days
• CPC Class Codes: A61B 1/24 for the mouth, i.e. stomatoscopes, e.g. with tongue depressors tongue depressors per se A61B13/00; Instruments for opening or keeping open the mouth combined with saliva removers A61C17/00; mouth openers for animals A61D15/00
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 18/042 using additional gas becoming plasma
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/18 by applying electromagnetic radiation, e.g. microwaves radiation therapy A61N5/00
• CPC Class Codes: A61B 2017/00814 Surgery of the tongue, e.g. glossoplasty
• CPC Class Codes: A61B 2017/248 Operations for treatment of snoring, e.g. uvulopalatoplasty
• CPC Class Codes: A61B 2018/00321 Head or parts thereof
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00583 Coblation, i.e. ablation using a cold plasma
• CPC Class Codes: A61B 2018/126 bipolar
• CPC Class Codes: A61B 2018/1425 Needle
• CPC Class Codes: A61B 2018/1472 for use with liquid electrolyte, e.g. virtual electrodes
• CPC Class Codes: A61B 2090/0817 Spatulas or spatula like extensions
• CPC Class Codes: A61B 5/1072 measuring distances on the body, e.g. measuring length, height or thickness A61B5/1076 takes precedence

Abstract

Apparatus and methods for ventral only ablation of the tongue, for use in treating sleep apnea and related breathing disorders. An RF ablation probe or wand is inserted in ventral surface of a patient'"'"'s tongue in a superior plane along a longitudinal (i.e., anterior to posterior) axis of the tongue, to a predetermined depth. The wand is withdrawn, RF energy is applied, creating a lesion predominantly in the interior of the tongue in an anterior to posterior plane, thereby resulting in less scarring but appreciable movement of the posterior tongue base away from the posterior pharyngeal wall. Also disclosed is a tongue retractor device used for measuring the depth of wand insertion, lifting the tongue to expose the ventral surface of the tongue for the procedure, and providing a stop surface to inhibit further wand insertion.

Claims

1. A method for treating sleep apnea of a patient comprising:

measuring a longitudinal thickness of a tongue of the patient between a proposed insertion point on a ventral surface of the tongue and a terminal point before inserting an electro-surgical instrument;

determining an insertion depth of the electrosurgical instrument based on the measured longitudinal thickness,

wherein the longitudinal thickness of the tongue is measured with a device comprising;

an elongate measuring rod, the elongate measuring rod comprising linear distance measurement indicia;

a spatula for placement on a dorsal surface of the tongue at the terminal point; and

a sliding portion comprising an indicia marker and a stop region for placement at the proposed insertion point on the ventral surface of the tongue;

wherein measuring comprises;

placing the spatula portion in contact with the dorsal surface of the tongue at the terminal point; and

sliding the stop region toward the spatula portion until the stop region contacts the ventral surface of the tongue,

inserting a tip of an electro-surgical instrument at the insertion point on the ventral surface of the tongue of the patient;

advancing the electro-surgical instrument toward the terminal point on the dorsal surface of the base of the tongue in a region proximate to the posterior pharyngeal wall;

halting the advance of the tip of the electro-surgical instrument at a first distance from the terminal point;

applying energy to tissue adjacent the tip of the electro-surgical instrument; and

withdrawing the electro-surgical instrument while applying energy to tissue adjacent the tip of the electrosurgical instrument to create a lesion in the interior of the tongue, wherein creating the lesion results in contraction of a portion of the tongue which increases a distance between the base of the tongue and the posterior pharyngeal wall;

wherein the lesion has a greater dimension in the anterior to posterior direction than in the superior to inferior direction.

2. The method of claim 1, wherein the electro-surgical instrument is an RF-energy ablation device.

3. The method of claim 1, wherein the electro-surgical instrument is a plasma assisted electrosurgical ablation device.

4. The method of claim 1, further comprising:

ceasing the application of energy to the electro-surgical instrument at a second distance from the terminal point greater than the first distance prior to withdrawing the electro-surgical instrument.

5. The method of claim 1, wherein a stop is attached to the electro-surgical instrument, wherein the stop impedes insertion of the tip of the electro-surgical instrument beyond the first distance.

6. The method of claim 1, wherein the electro-surgical instrument includes:

an adjustable stop selectively settable along a length of the electro-surgical instrument, wherein the stop impedes advancement of the tip of the electro-surgical instrument beyond the first distance; and

linear indicia for indicating a distance between the tip of the electro-surgical instrument and the stop.

7. The method of claim 1, wherein the electro-surgical instrument is advanced along a sagittal line so as to avoid the ranine artery and the lingual nerve in the tongue.

8. The method of claim 1, wherein energy is applied to the electro-surgical instrument both during advancement and withdrawal of the instrument.

9. The method of claim 1, wherein the insertion point is 5-10 mm superior to the submandibular gland duct openings.

10. The method of claim 1, wherein the insertion point is within 10 mm of the midline sagittal plane of the tongue.

11. The method of claim 1, wherein a path of the electro-surgical instrument between the insertion point and the terminal point is within 10 mm of the midline sagittal plane of the tongue.

12. The method of claim 1, wherein the electro-surgical instrument comprises an elongate member having a distal and a proximal end, the instrument comprising at least one electrode adapted to apply electrical energy to tissue adjacent the proximal end of the tip.

13. The method of claim 1, wherein the first distance is 5-8 cm.

14. A method for use in ventral only ablation of a tongue of a subject, comprising the steps of:

(a) providing an electrosurgical device comprising;

(i) a retractor device for immobilizing the tongue in a connection with a ventral only ablation of the tongue procedure, comprising an elongate member comprising a proximal end and a distal end, the distal end of the elongate member angled downward to engage a dorsal surface of the base of the tongue;

a handle adjacent the proximal end of the elongate member;

a clamp adapted to slide along a first portion of the elongate member adjacent the handle;

a retractor portion attached to and extending downwardly from the clamp, the retractor portion comprising a proximal portion attached to the clamp and a distal engaging portion adapted to engage a ventral undersurface of the tongue when the clamp is slid toward the distal end of the elongate member; and

(ii) an elongate RF energy radiating member adapted for ventral insertion into the tongue from the ventral undersurface of the tongue, the RF radiating member having a proximal end and a distal end, the distal end radiating RF energy when inserted ventrally into the tongue;

and

an adjustable stop selectively settable along a length of the elongate member for inhibiting further insertion of the elongate member upon contacting of the retractor portion of the retractor device when inserted into the ventral undersurface of the tongue;

(b) using the handle of the retractor device, placing the distal end of the elongate member against the dorsal surface of the base of the tongue of a subject;

(c) sliding the clamp of the retractor device along a first portion of the elongate member adjacent the handle to move the distal engaging portion to engage the ventral undersurface of the tongue of the subject, thereby immobilizing the tongue;

(d) setting a position of the adjustable stop of the RF energy radiating member to a desired predetermined insertion depth;

(e) inserting the distal end of the RF energy radiating member into the ventral undersurface of the tongue of the subject to the predetermined insertion depth; and

(f) applying RF energy to the interior of the tongue of the subject to create a lesion on the interior of the tongue.

15. The method of claim 14, wherein the elongate RF radiating member further comprises:

linear indicia for indicating a distance between the adjustable stop and the distal end of the elongate member.

16. The method of claim 14, wherein the elongate RF energy radiating member comprises at least one electrode for delivering energy to tissue adjacent the distal end of the elongate member.

17. The method of claim 14, wherein the first portion of the elongate member includes linear measuring indicia, wherein the linear measuring indicia can be used to determine a distance between the distal end of the elongate member and the engaging portion of the retractor.

18. The method of claim 14, wherein the distal engaging portion of the retractor comprises a first curved member adapted to engage a first region adjacent to one side a midline sagittal plane of the tongue and a second curved member adapted to engage a second region adjacent the opposite side the midline sagittal plane of the tongue.

19. The method of claim 18, wherein the first and second curved members form a single continuous loop.

20. The method of claim 14, wherein the distal end of the elongate member comprises a flattened portion adapted to engage the dorsal surface of the base of the tongue.

21. The method of claim 14, wherein the elongate RF energy radiating member has a bend at a distance from the proximal end to form an angle of 5 to 30°

.

22. The method of claim 21, wherein the distance is 2-6 cm.