System and method for patient selection in treating sleep disordered breathing

• US 8,983,572 B2
• Filed: 10/28/2011
• Issued: 03/17/2015
• Est. Priority Date: 10/29/2010
• Status: Active Grant

• Current Assignee: Inspire Medical Systems, Inc.
• Original Assignee: Inspire Medical Systems, Inc.
• Inventors: Ni, Quan
• Primary Examiner(s): SIRIPURAPU, RAJEEV P
• Application Number:
  US13/283,928
• Publication Number:
  US 20120108945A1
• Time in Patent Office: 1,236 Days
• Field of Search: 600/410, 600/411, 600/425
• US Class Current: 600/410
• CPC Class Codes: A61B 2562/043 in a linear array
• CPC Class Codes: A61B 5/0878 using temperature sensing means
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 6/032 Transmission computed tomography [CT]
• CPC Class Codes: A61B 6/487 involving fluoroscopy
• CPC Class Codes: A61B 6/50 specially adapted for specific body parts; specially adapted for specific clinical applications
• CPC Class Codes: A61B 8/08 Detecting organic movements or changes, e.g. tumours, cysts, swellings A61B8/02 - A61B8/06 take precedence

Abstract

A system and method provides for determining patient eligibility for receiving an implantable upper airway stimulation system. Images and sensed data are obtained regarding an upper airway of a patient. Based on the obtained image and sensed data, an obstruction vector is determined according to a location, a pattern, and a degree of obstruction along the upper airway. A patient candidate filter is applied against a patient health profile. Patient eligibility is determined based on the obstruction vector and application of the patient candidate filter.

Claims

1. A method for screening patients comprising:

at least one of;

obtaining an image, via an imaging device, of a portion of an upper airway of a patient; and

sensing data, via a catheter insertable into the upper airway, regarding a portion of an upper airway of a patient, wherein the sensed data comprises at least one of a pressure and an airflow during respiration; and

automatically, via execution in a computer processor of machine readable instructions stored in non-volatile memory, performing;

determining, based on the obtained image and sensed data, an obstruction vector including a location, a pattern, and a degree of obstruction along the upper airway;

applying a patient candidate filter against a patient health profile; and

determining patient eligibility for implantable upper airway stimulation based on the obstruction vector and application of the patient candidate filter.

2. The method of claim 1, wherein applying the patient candidate filter comprises:

applying an array of parameters, one parameter at a time in succession, where a failure of the patient health history profile to match a respective one of the parameters of the patient candidate filter results in denial of patient eligibility.

3. The method of claim 2, wherein applying the series of parameters includes:

applying at least one of a continuous positive airway pressure (CPAP) parameter, a co-morbidity parameter, a body mass index (BMI) maximum parameter, an apnea-hypopnea index (AHI) threshold parameter, and an apnea-hypopnea index (AHI) cap parameter.

4. The method of claim 1, wherein determining the obstruction vector comprises characterizing the location of obstruction as least one of a velum location, an oropharnyx-tongue base location, and an epiglottis-larynx location.

5. The method of claim 4, wherein determining the obstruction vector comprises:

characterizing the pattern of obstruction as at least one of an antero-posterior pattern, a lateral pattern, a concentric pattern, and a composite pattern.

6. The method of claim 5, wherein determining the obstruction vector comprises:

characterizing the degree of obstruction as at least one of a non-existent obstruction, a partial obstruction, and a complete obstruction.

7. The method of claim 1, wherein determining the obstruction vector includes:

calculating and assigning a score representing the location, pattern, and degree of obstruction.

8. The method of claim 7, wherein determining the obstruction vector includes:

applying a weighting factor to at least one of the location, pattern, and degree of the obstruction.

9. The method of claim 1, wherein the imaging device comprises at least one of:

a direct imaging device to obtain a direct image of the portion of the upper airway including at least endoscopic imaging; and

an indirect imaging device to obtain an indirect image of the portion of the upper airway.

10. The method of claim 9, wherein the indirect imaging device comprises:

at least one of a computer tomography function, a magnetic resonance imaging function, a fluoroscopy function, and an ultrasound function.

11. The method of claim 1, wherein sensing data via the catheter comprises:

arranging the catheter with a distal portion including at least an array of pressure sensors and an array of airflow sensors, wherein the sensors of each respective array are spaced apart from each other longitudinally along a length of the distal portion of the catheter.

12. A system for patient selection for treatment of sleep disordered breathing, the system comprising:

an imager to obtain images of an upper airway of a patient; and

a patient evaluation module including a computer processor to execute machine readable instructions, stored in a non-volatile memory, to determine patient eligibility via;

a physiologic determination module cooperative with the imager to determine a location, pattern, and a degree of obstruction within the upper airway based on the images;

a patient candidate filter to apply an array of patient candidate parameters against a patient health profile to produce patient candidate information; and

an obstruction vector module to determine an obstruction vector based on the determined location, pattern, and degree of obstruction, wherein the patient evaluation module uses the patient candidate information and the obstruction vector to automatically determine patient eligibility for implantable upper airway stimulation.

13. The system of claim 12, comprising

an elongate flexible sensing catheter including at least one of an array of pressure sensors and an array of airflow sensors, each array extending longitudinally along a distal portion of the catheter, wherein the sensing catheter is in communication with a controller to provide sensed data to the patient evaluation module.

14. The system of claim 13, wherein both the obstruction vector module uses the sensed data in combination with the images to determine the obstruction vector regarding the location, pattern, and degree of obstruction.

15. The system of claim 14, wherein the obstruction vector is configured to calculate and assign a score representing the location, pattern, and degree of obstruction.

16. The system of claim 14, wherein the obstruction vector is configured to apply a weighting factor to at least one of the location, pattern, and degree of the obstruction.

17. The system of claim 14 wherein the obstruction vector module includes a location parameter to characterize, based on at least one of the images and the sensed data, the location of obstruction as least one of a velum location, an oropharnyx-tongue base location, and an epiglottis-larynx location.

18. The system of claim 17, wherein the obstruction vector comprises:

a pattern detector module configured to characterize, based on at least one of the images and sensed data, the pattern of obstruction as at least one of an antero-posterior pattern, a lateral pattern, a concentric pattern, and a composite pattern.

19. The system of claim 18, wherein the obstruction vector comprises:

a degree detector module configured to characterize, based on at

least one of the images and sensed data, the degree of obstruction as at least one of a non-existent obstruction, a partial obstruction, and a complete obstruction.

20. The system of claim 12, wherein the patient candidate filter is configured to apply an array of parameters, one parameter at a time in succession, where a failure of the patient health history profile to match a respective one of the parameters of the patient candidate filter results in denial of patient eligibility.

21. The system of claim 18, wherein the array of parameters includes a continuous positive airway pressure (CPAP) parameter, a co-morbidity parameter, a body mass index (BMI) maximum parameter, an apnea-hypopnea index (AHI) threshold parameter, and an apnea-hypopnea index (AHI) cap parameter.