Transnasal endoscope with integrated high resolution esophageal manometer

Abstract

The present disclosure concerns a diagnostic apparatus and related methods for assessing an internal condition of a body cavity. One such apparatus comprises a manometer integrated into an endoscope, wherein the endoscope comprises a flexible tube, the manometer is integrated into a distal end and / or exterior of the flexible tube, and a plurality of pressure sensors are spaced at intervals along a length of the manometer.

Description

TRANSNASAL ENDOSCOPE WITH INTEGRATED HIGH RESOLUTION ESOPHAGEAL MANOMETERCROSS-REFERENCE TO RELATED APPLICATION

[0001] This application claims priority to co-pending U.S. provisional application entitled, “Transnasal Endoscope with Integrated High Resolution Esophageal Manometer,” having application number 63 / 626,959, filed January 30, 2024, which is entirely incorporated herein by reference.TECHNICAL FIELD

[0002] This application is generally related to a diagnostic tool for assessing an internal condition of a body cavity.BACKGROUND

[0003] Gastrointestinal disorders affect millions of individuals of any age. For example, Gastroesophageal reflux disease (GERD) is one of the most common gastrointestinal disorders, with a prevalence of approximately 20% of adults in western culture and the prevalence of this disease increasing further due to the rise in obesity. The surgical treatment of GERD requires preoperative testing, including upper endoscopy and high resolution esophageal manometry. Furthermore, esophageal motility disorders are another type of gastrointestinal disorder that can require esophageal manometry testing.

[0004] Transnasal endoscopy is an upper endoscopy method that uses a thin diameter gastroscope (e.g., the outer diameter of a transnasal endoscope is approximately 2.0 mm to 13 mm, such as 5.4mm) which can be passed through the nose rather than the mouth and into the stomach. Whilst there are a number ofcommon side effects with traditional oral gastroscopy, the transnasal endoscopy procedure can assist in avoiding gagging, retching, and nausea due to minimal contact with the tongue.

[0005] Currently, high resolution esophageal manometry is a separate procedure that uses a thin diameter catheter-based manometer, where a flexible tube (e.g., the range in outer diameter of a high resolution manometry catheter is 2.7mm to 4.2mm) is placed by a nurse though a patient's nostril and into the esophagus. The end of the flexible tube is connected to a machine that records the pressure that is placed on the tube to measure the patient's esophageal motility via sensors that are positioned along a length of the tube that is inserted into the esophagus. During the procedure, the subject or patient is asked to swallow a small amount of water to evaluate how well the sphincter and esophageal muscles are working, with the procedure typically lasting 10 to 15 minutes.

[0006] One limitation to this procedure is that many patients do not tolerate blind placement of the manometry catheter due to discomfort, pain, gagging, retching, or nausea. In addition, placement of the manometry catheter while the patient is awake frequently leads to significant patient anxiety both before and during the procedure. There are few substitutes or alternatives to this procedure, and inability to complete the manometry procedure can interfere with surgical decision making.

[0007] There is a need for an improved diagnostic tool for assessing an internal condition of a body cavity, such as the esophagus, stomach, etc.SUMMARY

[0008] Embodiments of the present disclosure provide a diagnostic apparatus and related methods for assessing an internal condition of a body cavity. Briefly described,in architecture, one embodiment of the apparatus, among others, comprises a manometer integrated into an endoscope, wherein the endoscope comprises a flexible tube, the manometer is integrated into a distal end and / or exterior of the flexible tube, and a plurality of pressure sensors are spaced at intervals along a length of the manometer.

[0009] The present disclosure can also be viewed as providing methods for assessing an internal condition of a body cavity. In this regard, one embodiment of such a method, among others, comprises providing a manometer integrated into an endoscope, where the endoscope comprises a flexible tube, wherein the manometer is integrated into an exterior of the flexible tube, wherein a plurality of pressure sensors are spaced at intervals along a length of the manometer; inserting the endoscope integrated with the manometer in an internal cavity of a subject; and / or obtaining pressure readings from the endoscope integrated with the manometer in the internal cavity of the subject.

[0010] In one or more aspects for such methods and / or apparatuses, the endoscope integrated with the manometer comprises a handset control portion that is detachable from an insertable portion of the endoscope that is integrated with the manometer; an outer diameter of the diagnostic apparatus is approximately 2.5 mm to 13 mm.; a length of the diagnostic apparatus is approximately 0.8 meters to 1.2 meters; the diagnostic apparatus comprises an internal channel extending a length of the diagnostic apparatus; and / or a diameter of the internal channel is approximately 1.5 mm to 2.5 mm..

[0011] In one or more aspects, such apparatuses further comprise a video lens at a distal tip of the endoscope that is integrated with the manometer; and / or illumination light sources positioned at the distal tip.

[0012] In one or more aspects, such methods further comprise guiding a positioning of the pressure sensors within the internal cavity using a camera lens that is disposed on a tip of the endoscope; wherein video images are captured and transmitted to a display device from the endoscope during guiding of the positioning of the pressure sensors; detaching a handset control portion of the endoscope that is integrated with the manometer from an insertable portion of the endoscope after inserting the endoscope in the internal cavity of the subject; reattaching the handset control portion of the endoscope before removing the endoscope that is integrated with the manometer from the internal cavity of the subject; and / or removing the endoscope that is integrated with the manometer from the internal cavity of the subject without reattaching the handset control portion of the endoscope.

[0013] Other systems, methods, features, and advantages of the present disclosure will be or become apparent to one with skill in the art upon examination of the following drawings and detailed description. It is intended that all such additional systems, methods, features, and advantages be included within this description, and be within the scope of the present disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Many embodiments and aspects of the present disclosure can be better understood with reference to the following drawings. The components in the drawings are not necessarily to scale, emphasis instead being placed upon clearly illustrating the principles of the present disclosure. Moreover, in the drawings, like reference numerals designate corresponding parts throughout the several views.

[0015] FIGS. 1A and 1 B show an improved diagnostic tool in the form of a high resolution manometer integrated into an endoscope, in accordance with variousembodiments of the present disclosure, with FIG. 1 A having a straight in-line grip and FIG. 1 B having an angled pistol grip.

[0016] FIG. 2 shows a non-limiting exemplary view of a distal tip of the diagnostic tool of FIG. 1.

[0017] FIGS. 3A-3D depict an exemplary embodiment of a diagnostic tool in which a handset control portion can be detached from an insertable portion of the diagnostic tool, in accordance with various embodiments of the present disclosure, with FIG. 3A showing the handset control portion being attached to the insertable portion, FIG. 3B showing an embodiment wherein the handset control portion is detached from the insertable portion during manometric testing, FIG. 3C showing a straight-line grip, and FIG. 3D showing an angled pistol grip.DETAILED DESCRIPTION

[0018] The present disclosure provides various embodiments of a diagnostic tool or apparatus for assessing condition of a body cavity, such as an improved esophageal diagnostic tool in the form of a high resolution esophageal manometer integrated into a transnasal endoscope, which has manometry pressure sensors or transducers incorporated along the exterior of the endoscope portion of the esophageal diagnostic tool or device.

[0019] Currently transnasal endoscopes and high-resolution manometry catheters are separate devices. There are no existing devices that have their combined functionality. Accordingly, FIGS. 1A and 1 B show an improved diagnostic tool in the form of a high resolution esophageal manometer integrated into an endoscope (e.g., a transnasal endoscope), in accordance with various embodiments of the present disclosure, with FIG. 1 A showing the diagnostic tool with a straight in-line grip and FIG.1 B showing the diagnostic tool with an angled pistol grip (e.g., at 90 degrees). Such a device enables medical personnel to perform two procedures (endoscopy and high- resolution manometry (e.g., esophageal manometry)) using one device. As illustrated in FIG. 1 A and FIG. 1 B, the diagnostic tool 100 provides a medical flexible endoscope 110 comprised of a flexible tube having a video camera lens 210 (FIG. 2) and illumination light sources 220 (FIG. 2) (e.g., LED light(s), fiber optic lights, etc.) positioned at a distal tip 120 of the diagnostic tool 100. In various non-limiting embodiments, the endoscope 1 10 is about 0.8 meters to about 1.2 meters in length and has an outer diameter of between about 2.0 mm to about 13 mm (e.g., between 2.5mm and 5.4 mm) and has an internal channel 230 of about 1.5 mm to about 2.5 mm in diameter. Accordingly, it is noted that the length and / or size of components, such as a length of the flexible endoscopic tube 110, in the drawings are not necessarily to scale in order to fit within set drawing margins. Thus, the drawings are intended to be relied upon to clearly illustrate the principles of the present disclosure.

[0020] Correspondingly, FIG. 2 shows a non-limiting exemplary view of the distal tip 120 showing the video camera lens 210 positioned on a periphery of the distal tip 120 of diagnostic tool 100 with a plurality of illumination light sources 220 also positioned around the periphery of the distal tip 120 (surrounding the internal channel 230) that can emit light that serves to illuminate living tissue of the subject of the diagnostic treatment.

[0021] Referring back to FIGS. 1A and 1 B, the diagnostic tool 100 houses the video camera lens 210 at the distal tip 120 of the diagnostic tool 100 and related video camera circuitry (e.g., memory) that is housed in a handle control portion 130 of the diagnostic tool 100 at a proximal end 140 of the diagnostic tool 100 or alternatively at or near the distal tip 120 (e.g., image sensor comprising a charge coupled device(CCD) or a complementary metal-oxide semiconductor (CMOS)). Video images captured by the diagnostic tool 100 can be transmitted over a data link 152 (e.g., a wired cable connection, a wireless connection, etc.) to an equipment console 150, such as a computer device having one or more computer processors or memory units, that is configured to execute image processing and / or signal processing software on a still image or a moving image captured by imaging an inside of an observation target (e.g., the inside of a subject’s esophagus or stomach, among other possible and nonlimiting targets). Accordingly, the equipment console 150 may include a display device or monitor that can display the captured video images or other visual displays provided by software executed on the equipment console 150. As such, display data can be generated and shown in a variety of forms, including graphs, numbers, images, sounds, mappings, etc. Alternatively, or in addition to, a display 135 may also be integrated into the handle control portion 130 to allow for an operator of the diagnostic tool 100 to view live camera images during insertion of a portion 105 in a cavity of a patient / subject, as illustrated in FIG. 1 B.

[0022] In certain embodiments, to enable transmission of data signals and / or power signals between the equipment console 150 and the diagnostic tool 100, one or more plugs or socket connections 160 for equipment / power / data cables 165 to the equipment console 159 are provided to couple to corresponding plugs, ports, or sockets of the equipment console (or any other type of electrical device as needed) via data / power link 152. To provide signaling between components at a distal tip and components at a proximal end of the diagnostic tool 100, electrical leads or lines (not shown) are positioned in one or more passageway extending a length of the endoscope between the respective components. In various embodiments, only oneset of connections 160 may be provided, where in some embodiments a plurality of sets of connections 160 may be provided, as shown in FIGS. 1A-1 B.

[0023] Referring back to FIG. 2, in the center of the distal tip 120, an internal channel 230 is provided that extends a length of the endoscope 110 which allows for biopsy instruments to be inserted through the internal channel 230. Accordingly, in various embodiments, the diagnostic tool 100 is equipped with a biopsy channel port 180 that couples to the internal channel 230, such that a proximal end of the channel port 180 can be used to insert an elongate biopsy instrument (such as, but not limited to, biopsy forceps) and feed the biopsy instrument into the internal channel 230 and through the distal tip 120 into a body cavity of the subject. Correspondingly, in various embodiments, a channel port (not shown) may also be provided to connect medical equipment that is configured to performing a suctioning action or water dispensing action that can be input into the air / water channel 240 and allows for a suctioning action to be performed and / or allows for fluids to be moved or irrigated through an air / water channel 240 and through the distal tip 120.

[0024] As previously stated, a proximal end of the diagnostic tool 100 is coupled to a handle control portion or unit 130, which may be, but is not limited to only being, in the form of a straight in-line grip, as shown in FIG. 1A, or in the form of a pistol grip, as shown in FIG. 1 B, in certain embodiments. In various embodiments, the handle control unit 130 is equipped with one or more controls for performing different operations or functions by the diagnostic tool 100. For example, a distal tip 120 of the diagnostic tool 100 may have a bending capability that is controlled by a lever 132 of the handle control unit 130. Thus, by moving the lever 132 in a certain direction and / or angle, the distal tip 120 may make a corresponding bending movement or action in the same direction (via bending wires that connect the lever to the bending portion ofthe distal tip and are positioned in an interior passageway (not shown) of the diagnostic tool 100). Additional controls can include button(s) 134, dial(s) 136, etc. which can control or activate various functions of the diagnostic tool, such as, but not limited to, illumination via the illumination light source(s) 220, video capture via the video lens 210, stiffening of the flexible tube of the endoscope 110, etc. In certain embodiments, as shown in FIG. 1 B, the handle control unit 130 may feature a small display unit 135 to show a live or real-time display of images being captured by the lens unit 210. Alternatively, the handle control unit 130 may include a video port or connector 137 for connecting to an external monitor, as illustrated in FIG. 1A. In various embodiments, additional controls may also be used in concert with the hand controls or in place of the hand controls, such as a foot pedal (not shown).

[0025] In various embodiments, the diagnostic tool 100 further comprises an external manometer 190 that is integrated into an exterior of the endoscope portion 110 of the diagnostic tool 100. The external manometer 190 extends a length of the endoscope 110 and contains a plurality of pressure sensors 195 (e.g. , 10-40 pressure sensors) that are spaced at regular intervals (e.g., 1 cm) starting near the distal tip of the diagnostic tool 100. In various embodiments, the pressure sensors (e.g., solid state pressure sensors, fluid filled pressure sensors, etc.) convert applied pressure into electrical signals that are supplied as inputs to recording software of the equipment console 150 (or other medical equipment). Thus, the pressure sensors 195 provide a method of obtaining pressure readings within a cavity of a subject, such as the pressure readings within an esophagus of the subject that can be used to assess swallowing disorders or other ailments that may be affecting the subject by providing a series of pressure measurements at different points along the cavity of the subject.

[0026] In accordance with various embodiments, pressure measurements obtained by the pressure sensors 195 of the diagnostic tool 100 can be transmitted to the equipment console 150 which is configured to execute signal processing software on the pressure readings (e.g., the inside of a subject’s esophagus or stomach, among other possible and non-limiting targets) to identify changes in the pressure measurements and to map to diagnostic values that indicate items of interest, such as diagnostic swallowing functions when the diagnostic tool 100 is used as in esophageal manometry testing. Accordingly, a display device or monitor of the equipment console 150 may show analysis and measurement outputs (e.g., three dimensional chart) provided by software executed on the equipment console 150. As such, display data can be generated and shown in a variety of forms, including graphs, numbers, images, sounds, mappings, etc. To provide signaling between the pressure sensors 195 and components at a proximal end of the diagnostic tool 100, electrical cable(s) or leads (not shown) are positioned in one or more passageways extending a length of the endoscope 110 between the respective components.

[0027] In practice, such as during an esophageal manometry, the diagnostic tool 100 can be used to measure how well the esophagus of a subject or patient is working. Accordingly, starting with the distal tip 120 of the diagnostic tool 100, the tool can be inserted through a nose of the patient and passed into the esophagus cavity of the patient. Via the pressure sensors 195, the pressure of the sphincter muscle of the patient / subject can be recorded and the contraction waves of swallowing can be recorded along the spaced intervals of pressure sensors along a length of the tool.

[0028] With the integrated endoscope 110 being part of the diagnostic tool 100, the tool can be moved into position under endoscopic guidance which makes the positioning of the tool more comfortable in comparison to conventional manometrywhere an insertable tube is blindly inserted into a patient’s body without the assistance of a camera. Thus, direct endoscopic visualization of the nares / nostrils, posterior pharynx, and esophagus will lead to decreased patient discomfort and anxiety while the diagnostic tool 100 is being placed, and subsequently lead to increased patient tolerance, compliance, and success in completing the manometry procedure. Accordingly, the diagnostic tool 100 can enable a physician to complete both endoscopy and manometry in an office setting (rather than in an outpatient procedure / surgery center), decreases anesthesia exposure to the patient, decreases patient need for additional visits, and / or can lead to greater in office productivity.

[0029] Another one of the biggest challenge with manometry testing is that the patient is awake during the procedure and is asked to swallow sips of fluids (e.g., water) through their mouth while a tube has been inserted in the patient’s esophagus. Thus, in various embodiments, a handle control portion 130 of the diagnostic tool 100 can be detached or disconnected from the remaining portion 105 of the diagnostic tool that is inserted in the patient’s body passageway (e.g., nasal passageway). For example, in FIG. 3A, the handset control portion 130 of the diagnostic tool 100 features a receiving connection, slot, or socket 142 that mates with a plug, pin, or prong insertable connection 144 for an insertable portion of the diagnostic tool 100. Accordingly, in various embodiments, the respective parts or portions of the diagnostic tool 100 can be pushed or snapped together to allow for the handset control unit 130 to operate functionality of the insertable portion 105 (e.g., such as operating the video lens, move the distal tip, etc.) and can be pulled apart or disconnected from one another.

[0030] Here, in various embodiments, an equipment cable can extend from the equipment console 150 and be coupled to and mate with data / power connectors 160on the insertable portion 105 of the diagnostic tool. In various embodiments, the equipment console can include a pressure sensing equipment console that is configured with appropriate software to take pressure measurement readings, where the handset control portion 130 can detach from the diagnostic tool during the pressure sensing or manometry testing, since the handset control portion 130 may be bulky and clunky and unwieldy for the physician (or other person) to hold during the manometry testing, given that the controls may not being used for endoscopic actions. Accordingly, when the handset control portion 130 is disconnected, the equipment console can be connected to data / power connectors 160 of the insertable portion 105 of the diagnostic tool. Thus, for patient comfort, the handset control portion 130 may be disconnected from the diagnostic tool 100 during manometry testing and then reattached or connected to the handset control portion 130 to perform endoscopic examinations or evaluations, such as those involving nasal and digestive cavities, as shown in the exemplary illustration of FIG. 3B. Accordingly, when the handset control portion 130 is connected to the insertable portion 105, the equipment console can be connected to the data / power connectors 160 of the handset control portion 130 (via a equipment / power / data cable 165). Thus, FIG. 3C shows the handset control portion 130 having a straight in-line grip connected to the insertable portion 105 of the diagnostic tool while the insertable portion 105 is inserted in a body cavity of the patient / subject 199. Correspondingly, FIG. 3D shows the handset control portion 130 having an angled pistol grip connected to the insertable portion 105 of the diagnostic tool while the insertable portion 105 is inserted in a body cavity of the patient / subject 199.

[0031] A diagnostic tool 100 of the present disclosure may be beneficial for diagnosing various ailments, such as gastroesophageal reflux disease (GERD) whichis one of the most common gastrointestinal disorders with a prevalence of approximately 20% of adults in western culture and the prevalence of this disease increasing further due to the rise in obesity. While illustrative examples are provided in the present disclosure for insertion of the diagnostic tool using a nasal cavity, the present disclosure is not limited to using only nasal cavity passageways. For example, the diagnostic tool could be inserted through other passageways and used to explore other body cavities of a patient, such as those involving, but not limited to, anorectal examinations or testing for assessing the pressure activity of the rectum and anal sphincter muscles.

[0032] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range, is encompassed within the disclosure. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the disclosure, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the disclosure.

[0033] It should be emphasized that the above-described embodiments of the present disclosure are merely possible examples of implementations, merely set forth for a clear understanding of the principles of the disclosure. Many variations and modifications may be made to the above-described embodiment(s) without departing substantially from the principles of the present disclosure. All such modifications andvariations are intended to be included herein within the scope of this disclosure. This device can also be integrated into a standard size or2T (diameter 12.6mm) endoscope to evaluate manometric lower esophageal pressures during surgical hiatal hernia repair and / or fundoplication procedures.

Claims

CLAIMSTherefore, at least the following is claimed:

1. A diagnostic apparatus for assessing an internal condition of a body cavity, comprising: a manometer integrated into an endoscope, wherein the endoscope comprises a flexible tube, wherein the manometer is integrated into a distal end and / or exterior of the flexible tube, wherein a plurality of pressure sensors are spaced at intervals along a length of the manometer.

2. The diagnostic apparatus of claim 1 , wherein the endoscope integrated with the manometer comprises a handset control portion that is detachable from an insertable portion of the endoscope that is integrated with the manometer.

3. The diagnostic apparatus of claim 1 , wherein an outer diameter of the diagnostic apparatus is approximately 2.5 mm to 13 mm.

4. The diagnostic apparatus of claim 1 , wherein a length of the diagnostic apparatus is approximately 0.8 meters to 1 .2 meters.

5. The diagnostic apparatus of claim 1 , wherein the diagnostic apparatus comprises an internal channel extending a length of the diagnostic apparatus.

6. The diagnostic apparatus of claim 5, wherein a diameter of the internal channel is approximately 1 .5 mm to 2.5 mm.

7. The diagnostic apparatus of claim 1 , further comprising a video lens at a distal tip of the endoscope that is integrated with the manometer.

8. The diagnostic apparatus of claim 7, further comprising illumination light sources positioned at the distal tip.

9. A method for assessing an internal condition of a body cavity, comprising: providing a manometer integrated into an endoscope, where the endoscope comprises a flexible tube, wherein the manometer is integrated into an exterior of the flexible tube, wherein a plurality of pressure sensors are spaced at intervals along a length of the manometer; inserting the endoscope integrated with the manometer in an internal cavity of a subject; and obtaining pressure readings from the endoscope integrated with the manometer in the internal cavity of the subject.

10. The method of claim 9, further comprising guiding a positioning of the pressure sensors within the internal cavity using a camera lens that is disposed on a tip of the endoscope.

11. The method of claim 10, wherein video images are captured and transmitted to a display device from the endoscope during guiding of the positioning of the pressure sensors.

12. The method of claim 9, further comprising detaching a handset control portion of the endoscope that is integrated with the manometer from an insertable portion of the endoscope after inserting the endoscope in the internal cavity of the subject.

13. The method of claim 12, further comprising reattaching the handset control portion of the endoscope before removing the endoscope that is integrated with the manometer from the internal cavity of the subject.

14. The method of claim 12, further comprising removing the endoscope that is integrated with the manometer from the internal cavity of the subject without reattaching the handset control portion of the endoscope.

15. The method of claim 9, wherein an outer diameter of the endoscope is approximately 2.5 mm to 13 mm.

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