WO2016154577A1

WO2016154577A1 - Method and apparatus for determining the orientation of an endoscope relative to gravity during use and for recording the same

Info

Publication number: WO2016154577A1
Application number: PCT/US2016/024304
Authority: WO
Inventors: Albert Yung-hsiang HUANG; Brian James DUNKIN
Original assignee: The Methodist Hospital
Priority date: 2015-03-25
Filing date: 2016-03-25
Publication date: 2016-09-29

Abstract

Apparatus for determining the orientation of an endoscope relative to gravity, the apparatus comprising: a cap sized for mounting to the endoscope, the cap having a lumen extending therethrough; a circular channel disposed about the lumen; and at least one visually-discernable object movably disposed in the circular channel so that the at least one visually-discernable object automatically aligns itself with gravity; such that when the cap is mounted to the endoscope, the position of the at least one visually-discernable object is visible to the user when viewing through the endoscope.

Description

METHOD AND APPARATUS FOR DETERMINING THE ORIENTATION OF

AN ENDOSCOPE RELATIVE TO GRAVITY DURING USE

Applicant

The Methodist Hospital

Inventors

Albert Yung-Hsiang Huang

Brian James Dunkin

Reference To Pending Prior Patent Application

This patent application claims benefit of pending prior U.S. Provisional Patent Application Serial No. 62/137,937, filed 03/25/2015 by The Methodist Hospital and Albert Yung-Hsiang Huang et al . for METHOD AND APPARATUS FOR DETERMINING THE ORIENTATION OF AN ENDOSCOPE RELATIVE TO GRAVITY DURING USE AND FOR RECORDING THE SAME (Attorney's Docket No. METHODIST-19 PROV) , which patent application is hereby incorporated herein by reference. Field Of The Invention

This invention relates to medical procedures and apparatus in general, and more particularly to

endoscopes and to the use of the same.

Background Of The Invention

In many situations it may be necessary or

desirable to visualize internal anatomical structures.

In some cases the internal anatomical structures may be exposed (e.g., through a surgical incision) so that the internal anatomical structures can be

visualized directly.

In other cases an endoscope may be inserted into the body (e.g., through a natural orifice or through a small surgical incision, which may or may not be lined with an access cannula) so that the internal

anatomical structures can be visualized via the endoscope. This endoscopic visualization of the internal anatomical structures may be recorded as still images or as video. In still other cases a scanner (e.g., an

ultrasound scanner, an X-ray machine, a CT scanner, an MRI scanner, a SPECT scanner, a PET scanner, etc.) may be used to visualize the internal anatomical

structures. This scanner-based visualization of the internal anatomical structures may be recorded as still images, as video, as computer models, etc.

The present invention is directed to the use of endoscopes to visualize internal anatomical

structures .

When endoscopes are used to visualize internal anatomical structures, the user is essentially

provided with a remote visualization of the internal anatomical structures, and there can be something of a "disconnect" between the orientation of the user and the orientation of the images acquired by the

endoscope. For this reason, it would be helpful for the user to also be provided with information about the physical disposition of the endoscope within the body as the images are being acquired, since this can provide the user with context for the images acquired by the endoscope and assist the user in better

identifying internal anatomical structures.

By way of example but not limitation, when navigating an endoscope through the upper

Gastrointestinal (GI) tract as well as through the lower GI tract, and/or through the respiratory system, knowing the orientation of the endoscope can be important for target tissue identification, target tissue localization (e.g., in the case of neoplasms and other pathologies) and/or accurate tissue

dissection .

By way of further example but not limitation, in the case of Per Oral Endoscopic Myotomies (POEMs), dissection typically occurs between delicate tissue planes and in extremely narrow spaces. The user generally relies on visual cues in the tissue to maintain their sense of orientation, but small changes to the operating field can result in deviations from the planned track. If the user could be provided with an indication of the endoscope's orientation relative to gravity, the user would have a more accurate sense of the anatomical structures that are being viewed and operated on.

By way of still further example but not

limitation, in procedures where the lumen and walls of the upper GI tract and/or the lower GI tract need to be evaluated and target tissues localized, providing the user with an indication of the endoscope's orientation relative to gravity would provide the user with a more accurate sense of their visual

orientation, and thus enable more effective and safer procedures .

Summary Of The Invention

The present invention provides a novel method and apparatus for determining the orientation of an endoscope relative to gravity during use.

Significantly, the endoscope orientation information is automatically integrated into the endoscope image information so as to provide a context-enhanced image to the user. Furthermore, to the extent that the endoscope image information is recorded, the present invention also allows the endoscope orientation information to be simultaneously recorded with the endoscope image information so as to provide a more robust data record of the visualization procedure.

In one preferred form of the invention, a

circular channel (e.g., a passageway or groove) is provided at the distal end of the endoscope, with the circular channel being visible in the endoscope image. A visually-discernable object is movably disposed in the circular channel so that the visually-discernable object will automatically align itself with gravity regardless of the orientation of the endoscope. As a result of this construction, the user can

simultaneously observe the internal anatomical

structures and the position of the visually- discernable object in the circular channel, so that the user will always know the orientation of the endoscope relative to gravity at the time that the internal anatomical structures are being visualized. In one preferred form of the present invention, there is provided apparatus for determining the orientation of an endoscope relative to gravity, the apparatus comprising:

a cap sized for mounting to the endoscope, the cap having a lumen extending therethrough;

a circular channel disposed about the lumen; and at least one visually-discernable object movably disposed in the circular channel so that the at least one visually-discernable object automatically aligns itself with gravity;

such that when the cap is mounted to the

endoscope, the position of the at least one visually- discernable object is visible to the user when viewing through the endoscope.

In another preferred form of the present

invention, there is provided apparatus for visualizing an internal site, the apparatus comprising:

an endoscope; and apparatus for determining the orientation of the endoscope relative to gravity, the apparatus

comprising :

a cap mounted to the endoscope, the cap having a lumen extending therethrough;

a circular channel disposed about the lumen; and

at least one visually-discernable object movably disposed in the circular channel so that the at least one visually-discernable object automatically aligns itself with gravity;

such that the position of the at least one visually-discernable object is visible to the user when viewing through the endoscope.

In another preferred form of the present

invention, there is provided a method for determining the orientation of an endoscope relative to gravity, the method comprising:

providing apparatus comprising:

a cap sized for mounting to the endoscope, the cap having a lumen extending therethrough; a circular channel disposed about the lumen; and

such that when the cap is mounted to the endoscope, the position of the at least one visually- discernable object is visible to the user when viewing through the endoscope;

mounting the cap to the endoscope; and

determining the orientation of the endoscope by observing the position of the at least one visually- discernable object within the circular channel, whereby to determine the orientation of the endoscope relative to gravity.

In another preferred form of the present

an endoscope comprising a lumen; and

In another preferred form of the present

providing a circular channel disposed about a lumen in the endoscope, and providing at least one visually-discernable object movably disposed in the circular channel so that the at least one visually- discernable object automatically aligns itself with gravity, such that the position of the at least one visually-discernable object is visible to the user when viewing through the endoscope; and

Brief Description Of The Drawings

These and other objects and features of the present invention will be more fully disclosed or rendered obvious by the following detailed description of the preferred embodiments of the invention, which is to be considered together with the accompanying drawings wherein like numbers refer to like parts, and further wherein:

Figs. 1-3 are schematic views showing novel apparatus for determining the orientation of an endoscope relative to gravity during use;

Fig. 3A is a schematic sectional view showing the circular channel as a closed passageway, whereby to movably capture the visually-discernable object within the circular channel;

Fig. 3B is a schematic sectional view showing the circular channel as a groove comprising an undercut, whereby to movably capture the visually-discernable object within the circular channel;

Fig. 4 is a schematic view showing another form of the novel apparatus for determining the orientation of an endoscope relative to gravity during use;

Figs. 5 and 6 are schematic views showing

exemplary constructions of the novel apparatus for determining the orientation of an endoscope relative to gravity during use; and

Fig. 7 is an exemplary view showing the image generated by the endoscope, which includes

visualization of the internal anatomical structures and visualization of the visually-discernable object movably disposed in the circular channel, so that the user will always know the orientation of the endoscope relative to gravity at the time that the internal anatomical structures are being visualized.

Detailed Description Of The Preferred Embodiments

Looking first at Figs. 1-3, there is shown a removable, disposable (preferably polymer) cap 5 that fits onto the end of an endoscope 10. Cap 5 is used to determine the position of endoscope 10 relative to gravity in real time. Cap 5 comprises a central lumen 12 extending therethrough, and a circular channel 15 having one or more visually-discernable objects 20 movably disposed therein. By way of example but not limitation, circular channel 15 may comprise a passageway (e.g., a sealed passageway) or groove, and the one or more visually-discernable objects 20 may comprise one or more small balls (or beads) movably captured therein. Cap 5 is intended to be mounted on the distal end of endoscope 10, so that the one or more visually-discernable objects 20 always remain at the lowest point relative to gravity of the circular channel 15 and, as such, indicate the orientation of cap 5 (and hence the orientation endoscope 10) relative to gravity.

Where circular channel 15 comprises a sealed passageway, circular channel 15 preferably has clear walls so as to allow easy visualization of the

position of the one or more visually-discernable objects 20 (e.g., small balls or beads) in circular channel 15 by means of the camera on endoscope 10. If desired, circular channel 15 may be inset into the side wall of the cap 5 so as to maintain a smooth inner surface within the cap.

Alternatively, circular channel 15 may comprise a groove formed in the side wall of cap 5. In this case, the groove preferably comprises an undercut (see, for example, Fig. 3A) so as to movably capture the one or more visually-discernable objects 20 (e.g., small balls or beads) in circular channel 15.

In one form of the invention, the one or more visually-discernable objects 20 comprise small, free- moving balls or beads which is/are made out of ceramic (or another inert, biocompatible material with

no electrical charge) and which reside (s) in a

circular channel 15 that has smooth walls and which may have a light lubricant coating thereon so as to facilitate the free movement of the one or more visually-discernable objects 20 (e.g., free moving balls or beads) in circular channel 15. The one or more visually-discernable objects 20 (e.g., free moving balls) may be white, or the one or more free- moving visually-discernable objects 20 (e.g., balls or beads) may be colored in a high visibility color

(e.g., yellow, green, blue, etc.) of the sort not typically seen in the body, whereby to ensure clear viewing of the one or more visually-discernable objects 20 (e.g., balls or beads) and provide high contrast with background features during a procedure.

In one preferred form of the invention, circular channel 15 comprises a sealed passageway which has its interior isolated from the external environment while still being visible by the camera in the endoscope. This construction ensures that a medical procedure may be performed normally (i.e., as is with a standard endoscope cap) , with no impediment to the passage of instruments, devices or fluids/flushes through the working channel (s) of the endoscope.

Looking now at Fig. 4, in order to further facilitate orientation guidance to the user, small high visibility markings 25 may be placed at equidistant points around the inner circumference of cap 5. Markings 25 enable the user to achieve and maintain a highly specific endoscope orientation if desired. In other words, by observing the position of markings 25 relative to the one or more visually- discernable objects 20 (which are always aligned with gravity) , the user can position the endoscope with a highly specific orientation.

Significantly, since the one or more visually- discernable objects 20 are visible to the user as the user visualizes an anatomical site, the endoscope orientation information provided by the present invention is automatically integrated into the

endoscope image information so as to present a

context-enhanced image to the user.

Furthermore, to the extent that the endoscope image information is recorded, the present invention allows the endoscope orientation information to be simultaneously recorded with the endoscope image information so as to provide a more robust data record . The technique and concept of using a circular channel 15 (e.g., a passageway or groove) with one or more visually-discernable objects 20 (e.g., balls or beads) freely moving within the circular channel may be applied to substantially any endoscope. In this respect it is noted that, for the purposes of the present invention, the term "endoscope" in intended to encompass substantially any camera system intended for insertion into the body and where it is desirable to know camera position relative to gravity, e.g., a gastrointestinal scope such as a colonoscope, a bronchoscope, an arthroscope, a laryngoscope, a scope used in vascular procedures, etc.

Thus, removable cap 5 may be configured during the manufacturing process to fit substantially any endoscope (e.g., a gastrointestinal scope, a

bronchoscope, an arthroscope, etc., as well as those scopes used in vascular procedures) . The removable cap 5 can fit flexible endoscopes and rigid

endoscopes, and is intended to be installed on the tip of the endoscope prior to the procedure and may be removed and disposed of after the procedure.

In one preferred form of the invention, the dimensions of removable cap 5 are about 20 mm in length and about 13 mm in diameter. This is in line with the many prior art endoscopic caps currently available on the market (but which do not have the directional guidance feature of the present

invention), e.g., oblique caps and flat caps having lengths of 21 mm and 12.1 to 12.7 mm diameters. At the same time, the removable cap 5 of the present invention may be manufactured to be any length and/or diameter in order to suit the application desired.

If desired, the one or more visually-discernable objects 20 movably disposed in circular channel 15 may comprise a high density fluid filling a limited portion of circular channel 15.

Or, if desired, the one or more visually- discernable objects 20 may comprise a gaseous bubble in a liquid disposed in a closed circular channel 15. Or, if desired, the circular channel 15 may be permanently mounted to, or built into, endoscope 10.

Applications

Possible applications of the present invention include natural orifice operative procedures (NOTES), endoscopic procedures (e.g., biopsies, examinations, interventions, etc.), bronchoscopy, gastroscopy, colonoscopy, endoscopy (both upper and lower), push enteroscopy, pediatric scope-based procedures, minimally invasive orthopedic procedures, minimally invasive vascular procedures (e.g., saphenous vein harvesting, etc.) as well as minimally invasive neurosurgical / spinal procedures.

Modifications Of The Preferred Embodiments

It should be understood that many additional changes in the details, materials, steps and

arrangements of parts, which have been herein

described and illustrated in order to explain the nature of the present invention, may be made by those skilled in the art while still remaining within the principles and scope of the invention.

Claims

What Is Claimed

1. Apparatus for determining the orientation of an endoscope relative to gravity, the apparatus comprising:

such that when the cap is mounted to the

2. Apparatus according to claim 1 wherein the circular channel comprises a passageway formed in the side wall of the lumen.

3. Apparatus according to claim 2 wherein the passageway is sealed.

4. Apparatus according to claim 2 wherein at least a portion of the circular channel is

transparent .

5. Apparatus according to claim 1 wherein the circular channel comprises a groove formed in the side wall of the lumen.

6. Apparatus according to claim 5 wherein the groove comprises an undercut.

7. Apparatus according to claim 1 wherein the circular channel is recessed within the cap such that the side wall of the lumen comprises a smooth inner surface .

8. Apparatus according to claim 1 wherein the circular channel comprises a lubricant for facilitating movement of the at least one visually- discernable object within the circular channel.

9. Apparatus according to claim 1 wherein the cap comprises high visibility markings adjacent the circular channel.

10. Apparatus according to claim 9 wherein the high visibility markings are disposed at equidistant points about the circular channel.

11. Apparatus according to claim 1 wherein the at least one visually-discernable object comprises an inert, biocompatible material having no electrical charge .

12. Apparatus according to claim 11 wherein the at least one visually-discernable object comprises a ball or bead.

13. Apparatus according to claim 12 wherein the ball or bead comprises a ceramic.

14. Apparatus according to claim 11 wherein the ball or bead has a high visibility color.

15. Apparatus according to claim 1 wherein the at least one visually-discernable object comprises a high density fluid.

16. Apparatus according to claim 1 wherein the at least one visually-discernable object comprises a gaseous bubble in a liquid disposed in the circular channel .

17. Apparatus for visualizing an internal site, the apparatus comprising:

an endoscope; and

apparatus for determining the orientation of the endoscope relative to gravity, the apparatus

comprising : a cap mounted to the endoscope, the cap having a lumen extending therethrough;

a circular channel disposed about the lumen; and

18. A method for determining the orientation of an endoscope relative to gravity, the method

comprising :

providing apparatus comprising:

mounting the cap to the endoscope; and

19. Apparatus for visualizing an internal site, the apparatus comprising:

an endoscope comprising a lumen; and

20. A method for determining the orientation of an endoscope relative to gravity, the method

comprising :