Detection and treatment of abnormal esophageal sphincter functionality

• US 9,526,449 B2
• Filed: 05/03/2011
• Issued: 12/27/2016
• Est. Priority Date: 06/07/2010
• Status: Active Grant

• Current Assignee: Medical College of Wisconsin Incorporated
• Original Assignee: Medical College of Wisconsin Incorporated
• Inventors: Shaker, Reza
• Primary Examiner(s): Stout, Michael C
• Application Number:
  US13/702,258
• Publication Number:
  US 20130090573A1
• Time in Patent Office: 2,065 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00827 Treatment of gastro-esophageal reflux
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/0053 by applying pressure, e.g. compression, indentation, palpation, grasping, gauging
• CPC Class Codes: A61B 5/037 Measuring oesophageal pressure
• CPC Class Codes: A61B 5/076 Permanent implantations telemetry using implanted circuitry A61B5/0031; implanted stimulators for therapy A61N1/3605, A61N1/362, A61N1/372
• CPC Class Codes: A61B 5/103 Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes A61B5/08 takes precedence; measuring aids for tailors A41H1/00; measuring instruments specially adapted for dentistry A61C19/04
• CPC Class Codes: A61B 5/4211 Diagnosing or evaluating reflux
• CPC Class Codes: A61B 5/4233 oesophagus
• CPC Class Codes: A61B 5/687 Oesophagus
• CPC Class Codes: A61B 5/7246 using correlation, e.g. template matching or determination of similarity
• CPC Class Codes: A61F 2/50 Prostheses not implantable in the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004

Abstract

An esophageal device is used to recognize, diagnose, characterize, or relieve an impact of an abnormal or defective UES anatomy, physiology, or functionality. In one implementation, the esophageal device measures a UES response to esophageal fluid infusion to detect or characterize an abnormality or defective UES anatomy, physiology, or functionality. An Upper Esophageal Sphincter compression device is used to increase intra-luminal pressure within the Upper Esophageal Sphincter of a patient in order relieve an impact of an abnormal or defective UES anatomy, physiology, or functionality.

Claims

1. An esophageal device for diagnosing Upper Esophageal Sphincter (UES) pathology, the esophageal device comprising:

(a) a intra-luminal pressure sensor configured to measure UES pressure when the intra-luminal pressure sensor is located within an Upper Esophageal Sphincter of a patient;

(b) a fluid infusion device including;

tubing configured for insertion into an esophagus of a patient;

a pump configured to inject fluid into the tubing, wherein, when the tubing is inserted into the esophagus, injection of the fluid invokes a pharyngeal reflux in the patient; and

a controller configured to control a pump pressure of the pump;

(c) an output device;

(d) an article of manufacture communicatively coupled with the output device, the article of manufacture including a processor and a non-transitory computer readable medium having computer readable program code disposed therein, the computer readable program code comprising a series of computer readable program steps to effect;

receiving indicia about the UES pressure measured by the intra-luminal pressure sensor when the pharyngeal reflux occurs in the patient;

comparing the received said UES pressure of the patient with a predetermined said UES pressure, wherein the predetermined said UES pressure is determined from at least one said UES pressure of a corresponding control subject when the corresponding control subject experiences pharyngeal reflux; and

transmitting a result of the comparison to the output device accessible by a health care provider diagnosing the patient; and

(e) a non-invasive device that compresses a cricoid of the patient thereby changing the UES pressure detected by the intra-luminal pressure sensor, wherein the non-invasive device comprises;

a cushion, a band coupled to the cushion, and a coupling clasp attached to the band, wherein when the band is placed in tension in a preset configuration about a neck of the patient using the clasp, the cushion is compressed towards the cricoid and the UES pressure within the Upper Esophageal Sphincter is set at a predetermined intra-luminal pressure suitable for treating a patient having an abnormality in UES anatomy, physiology, or functionality,

wherein when the band is placed in the preset configuration using the clasp a relative position of a first end of the band to a second end of the band provides an identifier that the non-invasive device will induce the predetermined intra-luminal pressure.

2. The esophageal device of claim 1 wherein the controller is configured to control a rate of the pump pressure.

3. The esophageal device of claim 1 wherein the controller is configured to autonomically control at least one of:

the pump pressure;

a rate of change of the pump pressure;

a sequence of predetermined pump pressures;

a sequence of predetermined rates of change of the pump pressure; and

a combination of the foregoing.

4. The esophageal device of claim 1 wherein the fluid is selected from a group consisting of:

normal saline;

water;

air;

a fluid having a same viscosity as normal saline at room temperature; and

a combination of the foregoing.

5. The esophageal device of claim 1 wherein the received said UES pressure of the patient is received from the intra-luminal pressure sensor communicatively coupled with the article of manufacture.

6. A method for determining esophageal pressure, the method comprising:

(a) inserting a catheter into an esophagus of a patient, wherein the catheter;

includes an intra-luminal pressure sensor; and

is coupled to a pump configured to inject fluid into the catheter;

(b) providing data to a controller that varies a pump pressure of the pump, whereby fluid is injected into the catheter to invoke a pharyngeal reflux in the patient;

(c) associating the pharyngeal reflux with an intra-luminal pressure detected by the intra-luminal pressure sensor when the pharyngeal reflux occurs in the patient;

(d) comparing the intra-luminal pressure when the pharyngeal reflux occurs in the patient with a predetermined said intra-luminal pressure determined from at least one said intra-luminal pressure detected when one said pharyngeal reflux occurs in a corresponding control subject;

(e) diagnosing a functionality of a Upper Esophageal Sphincter (UES) of the patient based on a result of the comparison;

(f) using a Upper Esophageal Sphincter (UES) compression device to apply an external pressure to a cricoid of the patient until the intra-luminal pressure sensor denotes that the intra-luminal pressure is within a predetermined range;

(g) associating the intra-luminal pressure that is within the predetermined range with a value of an indicator of the UES compression device;

(h) removing the intra-luminal pressure sensor;

(i) releasing the external pressure; and

(j) prescribing that the value be reapplied to the indicator of the UES compression device, wherein the value is set at a predetermined amount suitable for treating a patient having an abnormality in UES anatomy, physiology, or functionality.

7. The method of claim 6 wherein the data to the controller that varies a pump pressure of the pump includes instructions to:

set a pump pressure of the pump;

set a pump pressure rate of change to the pump;

apply a sequence of predetermined rates of the pump pressure; and

a combination of the foregoing.

8. An Upper Esophageal Sphincter compression kit comprising:

(a) a non-invasive device that compresses a cricoid of a patient thereby changing an intra-luminal pressure within an Upper Esophageal Sphincter of the patient,

wherein the non-invasive device includes;

a cushion;

a band coupled to the cushion, and

a coupling clasp attached to the band,

wherein the band is configured to be in tension when placed in a preset configuration about a neck of the patient using the clasp;

wherein when the band is in the preset configuration, the cushion is compressed towards a cricoid of the patient and the intra-luminal pressure within the Upper Esophageal Sphincter of the patient is set at a predetermined intra-luminal pressure,

wherein when the band is in the preset configuration a predetermined amount of pressure is applied to the cricoid in order to reduce pharyngeal reflux in the patient while allowing the patient to open an Upper Esophageal Sphincter of the patient for other physiological events,

wherein when the band is placed in the preset configuration using the clasp a relative position of a first end of the band to a second end of the band provides an identifier that the non-invasive device will induce the predetermined intra-luminal pressure;

(b) a pressure sensor for correlating between the predetermined amount of pressure applied to the cricoid by the non-invasive device and the intra-luminal pressure within the Upper Esophageal Sphincter of the patient.

9. The Upper Esophageal Sphincter compression kit of claim 8 wherein the predetermined intra-luminal pressure is in a range of pressures between 10 and 70 millimeters of mercury.

10. The Upper Esophageal Sphincter compression kit of claim 8 further comprising a fluid infusion device including:

tubing configured for insertion into an esophagus of a patient;

a pump configured to inject fluid into the tubing inserted into the esophagus to invoke a pharyngeal reflux in the patient; and

a controller configured to control a pump pressure of the pump.

11. A method for reducing gastroesophageal reflux by increasing an intra-luminal pressure of an Upper Esophageal Sphincter (UES) of a patient, the method comprising:

(a) using a UES compression device to apply an external pressure to a cricoid of the patient;

(b) using a pressure sensor to correlate between the external pressure applied to the cricoid by the UES compression device and an intra-luminal pressure within the Upper Esophageal Sphincter of the patient wherein the external pressure is applied to the cricoid such that the intra-luminal pressure is within a predetermined range;

(c) associating the predetermined range of the intra-luminal pressure with a value of an indicator of the UES compression device; and

(d) prescribing that the value be reapplied to the indicator of the UES compression device.

12. The method of claim 11, wherein:

the value of the indicator of the UES compression device is a length of a band of the UES compression device.

13. The method of claim 11, further comprising:

repeating;

step (a);

step (b) and

(e) associating the predetermined range of the intra-luminal pressure with a second value;

and

(f) prescribing the second value be reapplied to the indicator of the UES compression device.