US-20260123989-A1 - Methods of Diode Laser Treatment of Nasal Valve Region

Abstract

There is provided a method of laser repair for the internal nasal valve region to improve the nasal airway. The method treats single or multiple sites in all regions that compose the nasal valve, including ablating of soft tissue and cartilage tissue on all sides of the nostril to increase airway patency. Treatments in tissue contact, non-contact, and interstitial modes are provided.

Inventors

• Yosef Krespi
• Ron Hadani

Assignees

• VALENT MEDICAL INC.

Dates

Publication Date

20260507

Application Date

20241105

Claims (16)

1. 1 . A method for treatment of nasal valve obstruction comprising: inserting a handheld laser device into a nostril of a patient; said handheld laser device having a handpiece section and connected to a diode laser at a proximal end of said handheld laser device, with laser energy delivered along fiber optic internal to the handheld laser device inside said handpiece section; said fiber optic extending from a distal end of said handpiece section and contained within a malleable sheath; said fiber optic culminating in a laser fiber optic tip at the distal end of said handheld laser device; delivering laser energy by said laser fiber optic tip to a selected treatment location within a nasal valve of said nostril; ablating obstructing tissue at said selected treatment location with said laser energy.
2. 2 . The method according to claim 1 further comprising as an initial step, the step of: retracting a nostril of patient with a retracting device to expose a nasal valve.
3. 3 . The method according to claim 1 wherein said handheld laser device operates in contact mode at more than 100 degrees Celsius.
4. 4 . The method according to claim 1 wherein said handheld laser device operates in non-contact mode at 60 to 90 degrees Celsius.
5. 5 . The method according to claim 1 wherein said handheld laser device operates in interstitial mode at more than 100 degrees Celsius.
6. 6 . The method according to claim 1 wherein said selected treatment location is upper lateral cartilage.
7. 7 . The method according to claim 1 wherein said selected treatment is lower lateral cartilage.
8. 8 . The method according to claim 1 wherein said selected treatment location is cartilaginous septal spurs.
9. 9 . The method according to claim 1 wherein said selected treatment location is fibro-fatty tissue.
10. 10 . The method according to claim 1 wherein said selected treatment location is a turbinate.
11. 11 . The method according to claim 1 wherein said selected treatment location is swell bodies.
12. 12 . The method according to claim 1 wherein said selected treatment location is herniated soft tissue of a nasal floor, like vestibular swell body.
13. 13 . The method according to claim 1 wherein said laser fiber optic tip is a 400 micron tip.
14. 14 . The method according to claim 1 wherein said laser fiber optic tip is a 400 micron malleable tip.
15. 15 . The method according to claim 1 wherein said treatment of nasal valve obstruction includes a pulse mode of laser treatment.
16. 16 . The method according to claim 1 wherein said treatment of nasal valve obstruction includes a continues mode of laser treatment.

Description

FIELD OF THE INVENTION The present invention relates to selective, targeted treatment of soft and hard tissues for the front of the nose and nasal vestibular area, and more particularly treatment of the nasal region with laser energy. BACKGROUND With respect to the internal nasal valve, the internal nasal valve is the narrowest portion of the nasal airway passage and regulates airflow resistance. It is bounded medially by the nasal septum and tuberculum of Zuckerkandl, superiorly and laterally by caudal margin of ULC (upper lateral cartilage), its fibrofatty attachment to the pyriform aperture, and the anterior head of the inferior turbinate. The nasal valve angle typically ranges between 10° and 15°. The entire nasal valve surface area averages 55-64 mm2. The patency of the internal nasal cavity is tested by Cottle's test, by stretching the nostrils laterally in order to demonstrate an improved airflow. For physiology of the nasal valve, the dynamic of airflow follows a parabolic curve as it passes through the nasal valve. It contributes to air turbulence. This optimizes contact between the air stream and mucosal surface in order to obtain maximum air conditioning effect (humidification, filtration, olfaction and temperature control of inhaled air). The nasal valve should be considered as an inflow regulator. The main airflow resistance of the whole respiratory tract is normally confined to the nasal valve area. For pathology, nasal valve problems can be primarily due to an inherent problem in this area, such as collapse of weaken or over resected alar cartilage during inspiration (i.e., result of esthetic rhinoplasty) or that the upper and lower lateral cartilages do not overlap. It is more common for this to occur secondary to septal deviation, turbinate hypertrophy or scarring of vestibular skin and this is termed secondary valve collapse. Surgeons have treated the nasal valve region presently or in the past by: 1.) implants, such as with open rhinoplasty and cartilage reconstruction, and local stenting; 2.) surgical resection and 3.) non-surgical remodeling of nasal valve structures, such as with radio frequency (RF). These single repair methods only partially address anatomical problems of the valve region. SUMMARY OF THE INVENTION The focus of the present invention is the laser induced changes to, and repair of the internal nasal valve region in order to improve the nasal airway patency in a unique fashion. The present invention is treating multiple sites and structures that compose the valve region, including erectile soft tissues and several cartilages. The present invention involves ablating, size reducing and shape changing of fatty tissue on one or more sides of the nostril to reduce obstructions and increase the cross-sectional area of the nasal valve section. While the conditions of static obstruction in the nasal valve are common, no two nasal valves are the same, and the present invention targets a laser treatment of erectile soft tissue or cartilage as to improve the airway patency. The main areas targeted include soft tissues of the turbinate or swell bodies, septal cartilage, upper lateral cartilage, and lower lateral cartilage. The present invention is a method for treatment of nasal valve obstructions where the method includes dilating and enlarging the nostril of a patient with a non-obstructing, self-retracting device to expose the nasal valve structures and then inserting a laser fiber tip which is connected to a laser handpiece into the nostril. The proximal end of the laser handpiece is connected to a diode laser source with a detachable trunk fiber optic cable. When connected to the proximal end of the laser handpiece, the distal end of the trunk fiber optic cable is connected internally to the proximal end of the laser fiber tip. The laser energy generated by the diode laser source is delivered along the trunk fiber optic cable to the laser fiber tip and to the treated nasal tissue. The fiber optic tip extends from a distal end of the laser handpiece and is contained within a malleable sheath where the fiber optic culminates as a fiber tip at the distal end of the laser handpiece. The method of the invention delivers laser energy by the fiber tip to a selected treatment location within the nasal valve section (nasal vestibule) and ablates obstructing tissue at the selected treatment location with the laser energy. In different embodiments of the method of the present invention, the laser handpiece operates with the distal end of the laser fiber tip in relation to the treated tissue, in “non-contact mode”, elevating the tissue temperature to at 60 to 90 degrees Celsius to reshape soft cartilage, in “interstitial mode” for reducing volume of erectile structures such as turbinate or swell bodies and fibro-fatty tissue, or in “contact mode” shaving septal cartilage spur. In embodiments of the present invention, the method of the present invention includes the selected treatment locat