EP3880058A1

EP3880058A1 - Swallow capsule endoscope

Info

Publication number: EP3880058A1
Application number: EP19842879.9A
Authority: EP
Inventors: Ivan MARTINCEK; Peter BANOVCIN
Original assignee: Zilinska Univerzita V Ziline; Univerzita Komenskeho
Current assignee: Zilinska Univerzita V Ziline; Univerzita Komenskeho
Priority date: 2018-11-12
Filing date: 2019-11-08
Publication date: 2021-09-22
Also published as: SK288864B6; SK1262018A3; WO2020099997A1; WO2020099997A4

Abstract

The swallow capsule endoscope comprises a modified truncated cone-shaped cavity capsule (1) in which an endoscopic module (A) is inserted which comprises an optical data transmission input formed by an optical system (7) connected to the imaging camera (3), and the imaging camera (3) in on the other side connected to the printed circuit board (5), the optical system (7) having side-by-side light-emitting diodes (4) to which the epoxy polymer cylinder (11) is glued, and to the printed circuit board (5) are connected by soldering by means of electrically conductive connections (6), electrical conductors (9) which are inserted into the dielectric protective tube (10) and lead out of the printed circuit board (5) of the endoscopic module (A), and between the optical system (7), the imaging camera (3), the epoxy polymer cylinder (11) and the light-emitting diodes (4) there is an air gap (8), and the rest of the cavity within the capsule (1) is filled with cured dielectric polymer (2), wherein the truncated cone of the capsule (1) is modified so that the surface of the cone base on which the optical input of the capsule (1) is located is larger than the area of the opposite cone base.

Description

SWALLOW CAPSULE ENDOSCOPE

FIELD OF THE INVENTION

The invention relates to the field of endoscopy devices.

STATE OF THE ART

Endoscopes are electro-optical instruments that are used to visualize the internal cavities of the human body. Specialized electro-optical devices used to visualize the upper parts of the digestive tract are called esophagoscopes and the examination performed by them is called esophagoscopy. Esophagoscopy is a routine examination that is currently performed by various methods. The most widespread examination of the esophagus is called esophagogastrodudenoscopy (EGD), which allows the upper part of the digestive tract to be examined optically from the esophagus to the duodenum. During EGD, a flexible tube with an outer diameter of up to 9.8 mm is inserted into the patient's digestive tract. The flexible tube incorporates a camera and illumination system for imaging the gastrointestinal tract, a working channel into which the sampling and treatment devices or other components are inserted. EGD examination is usually performed with the patient lying on the left side of his/her body. The patient must not eat or drink 12 hours prior to the examination. During the examination, an artificial protector is inserted into the patient's mouth and must be gently bitten during the examination. A flexible endoscopic tube is then inserted into the digestive tract through an artificial protector and performs the examination. The examination may be uncomfortable for the patient, in particular for the feeling of tightening for vomiting, inflation, saliva leakage, and belching. A more gentle examination of the esophagus is esophagoscopy through the nose, in which a flexible tube with a camera and a light source is inserted into the esophagus through the nose. The diameter of the tube is about 5 mm, which is almost half the diameter of the tube used in EGD. When the esophagus is examined by an esophagoscope through the nose, the patient sits upright on a chair. The patient must not eat or drink 3 hours prior to the examination. Esophagoscopy through the nose is less burdensome for the patient than EGD, and its cost is approximately a quarter of that of EGD. Another way of gentle examination of the digestive system is the so-called capsule endoscopy wherein a wireless transmission from the capsule transmits an image from the gastrointestinal tract to a display device. Capsule endoscopy has been developed mainly for the examination of the small intestine, which is difficult to investigate by other endoscopic methods, but studies are currently underway and test its use in the examination of the esophagus. The use of a capsule endoscope is as follows: the patient swallows a capsule with a built-in camera featuring illumination, a source of electromotive voltage and a transmitter that transmits a digital radio frequency signal. As the capsule moves through the digestive tract, it emits a radio frequency signal that is converted into an image in a receiver outside the patient. After the examination of the patient, the capsule comes out of the patient's body in a natural way. The US Patent No. 7530948 B2 "TETHERED CAPSULE ENDOSCOPE FOR BARRETT'S ESOPHAGUS SCREENING" discloses a capsule device that is coupled to a tether that is being manipulated to position the capsule and a scanner included within the capsule at the desired location within a lumen in a patient's body. Images produced by the scanner can be used to detect Barrett's Esophagus (BE) and early (asymptomatic) esophageal cancer after the capsule is swallowed and positioned with the tether to enable the scanner in the capsule to scan a region of the esophagus above the stomach to detect a characteristic dark pink colour indicating the BE. The capsule can also be used for diagnostic and/or therapeutic purposes in other lumens.

The disadvantage of imaging the esophagus is the fact that the capsule passes through the esophagus only once, and the doctor does not have the opportunity to move the capsule back to examine the parts of the esophagus in more detail. This drawback is partially remedied by capsule endoscopy, in which the capsule is attached by means of a vacuum suction cup to a selected part of the esophagus, on which it can be attached for several days and scan the surroundings of the attachment point. The disadvantage of this method is that the capsule only senses the surroundings of the grip and that the capsule attachment is done through the EGD of the esophagus, which puts a burden on the patient. The US Patent No. 4936823A "TRANSENDOSCOPIC IMPLANT CAPSULE" discloses an implant capsule for insertion into a body canal to apply radiation treatment to a selected portion of the body canal. The device includes a body member defining at least one therapeutic treatment material receiving chamber and at least one resilient arm member associated with the body member for removably engaging the body canal when the device is positioned therein.

SUMMARY OF THE INVENTION

Capsule endoscopy has been used in gastrointestinal tract examination for several years. Commercially available capsule endoscopy uses wireless technology to transmit the image from the capsule which transmits the image via electromagnetic waves to the imaging device. Both wireless and wired capsule endoscopy currently use capsule shapes that are commonly used in pharmacy to transport drugs across the gastrointestinal tract to the patient's body. These capsule shapes are planarly symmetrical.

The currently known shapes of a swallowable capsule make it difficult to remove the capsule from the esophagus because of overcoming the upper esophageal sphincter pressure. Published technical solutions of capsule endoscopes have guided feed wires to the capsule in its center at the beginning of the capsule. The lead wires positioned that way may cause the capsule to sink into the esophageal protective mucus layer which will contaminate the capsule endoscope objective.

These drawbacks are overcome by the proposed technical solution for swallowable capsule endoscopes according to which the capsule has the shape of a modified truncated cone.

The swallow capsule endoscope comprises a modified truncated cone-shaped capsule with a cavity in which an endoscopic module is inserted. The module includes an optical data transmission input formed by an optical system coupled to the imaging camera. The imaging camera, on the other hand, is connected to a printed circuit board, and the optical system has side-by-side light-emitting diodes to which an epoxy polymer cylinder is adhered. Electrical conductors are connected to the circuit board by soldering by means of electrically conductive connections which are inserted into the dielectric protective tube and lead out of the circuit board of the endoscopic module. There is an air gap between the optical assembly, the imaging camera, the epoxy polymer cylinder, and the light-emitting diodes, with the remainder of the cavity inside the capsule being filled with a cured dielectric polymer. The truncated cone of the capsule is modified so that the surface of the cone base from which the electrical conductors emerge is smaller than the surface of the base on which the optical inlet of the capsule is located.

The image from the gastrointestinal tract is transmitted to the imaging device for further processing by electrical conductors from a miniature capsule.

With the proposed capsule endoscope for the examination of the esophagus, practical tests have shown that a more suitable wire-fed capsule shape is that of a modified truncated cone, all sides of which are modified so that:

- all sides of the truncated cone are convex, or

- the bottom and top of the modified truncated cone are convex and the sides of the modified truncated cone are concave, or

- the bottom and top of the modified truncated cone are convex and the lateral sides of the modified truncated cone are straight.

Power to the camera and the capsule light source is provided by the thin current and voltage power cable connected to the capsule. The capsule is passed from the mouth to the esophagus by swallowing the capsule and swallowing enough water or other liquid, while the capsule also pulls the supply wires located in the mouth as it moves through the esophagus. In the esophagus, the capsule remains hanging on a cable containing power wires leading out of the patient's mouth to an electromotive voltage source for the camera and lighting, and a receiver for processing the video signal of the camera. The position of the capsule in the esophagus is adjusted by the length of the cable that is being swallowed.

The procedure for examination using a swallow capsule endoscope is as follows:

After swallowing the capsule and placing it in the esophagus, the upper esophageal sphincter is wrapped around the capsule power cable. After examination of the esophagus, the endoscopic capsule is removed from the esophagus by pulling on the power cable. Since the capsule has a larger diameter than the power cable, the clamped upper esophageal sphincter, which generates an average pressure of up to 8000 Pa, prevents the capsule from being withdrawn from the esophagus. When the capsule has the shape of a drug capsule as it is currently used, considerable effort is required to pull the capsule through the upper esophageal sphincter, since the capsule top and bottom surfaces are equally large. This pulling may damage both the mucosa of the upper esophageal sphincter and the capsule endoscope itself.

When the capsule has the shape of a modified truncated cone whose base area from which the power cable exits is smaller than the base area on which the optical capsule inlet is located, it is easier to remove the capsule by pulling on the power cable. This is because the capsule sinks into the upper esophageal sphincter with its thinner end when it is pulled out, which expands the sphincter to allow easier removal of the entire capsule.

On the mucous membrane of the esophagus, there is a mucous layer which has different thickness and composition in different patients. In addition, the capsule should be swallowed or flushed with enough water or other liquid during the investigation, causing complications to the imaging system of the endoscope camera to which mucus may stick. When the power cables are located in the centre of the capsule, it often happens that the conductor adheres to the mucus layer of the esophagus and the camera capsule enters the layer. This makes it impossible to get a quality image from the camera.

This problem is eliminated in the presented solution in that the power cable entering the capsule is not routed in its centre but through its side surface. After swallowing the capsule with the power cable positioned that way, due to adhering forces, the capsule power cable, guided along the side of the capsule, sinks into the esophagus mucus layer and the capsule lens remains a thickness of the power cable (a few millimeters) above the mucus layer. If the power cable adheres to the esophagus mucosa, which almost always happens, the camera capsule remains a few millimeters above the mucosa, ensuring that the camera imaging system is not contaminated. This technical solution can be applied if the camera is located on the opposite side to the conductors coming out of the capsule, but also in the so-called retrograde scanning when the optical entrance to the capsule is located on the same side as the exit of the conductors from the capsule. In the case of retrograde scanning, however, the advantage of simpler removal of the capsule from the esophagus is lost, since when the capsule is removed, the capsule enters its wider end into the upper esophageal sphincter.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure No. 1 shows a capsule with the shape of a modified truncated cone having all sides convex.

Figure No. 2 shows a modified truncated cone shape capsule with the lower and upper modified truncated cone base being convex and the sides of the modified truncated cone being concave.

Figure No. 3 shows a modified truncated cone shape capsule wherein the lower and upper modified truncated cone bases are convex and the sides of the modified truncated cone are straight.

Figure No. 4 shows the power cable leads from the capsule in the dielectric tube, the beginning of the dielectric tube being guided on the side of the capsule and the capsule power cable extending on the opposite side of that of the optical input.

Figure No. 5 shows the power cable leads from the capsule in the dielectric tube, the beginning of the dielectric tube being guided on the side of the capsule and the capsule power cable extending on the same side as the optical input.

APPFICATION EXAMPFES

The swallow capsule endoscope comprises a modified truncated cone-shaped capsule 1 with a cavity in which an endoscopic module A is inserted. It comprises an optical data transmission input formed by an optical system 7 connected to the imaging camera 3. On the other side, the imaging camera 3 is connected to the printed circuit board 5. The optical system 7 has side- mounted light-emitting diodes 4 to which the epoxy polymer cylinder 11 is adhered. Electrical conductors 9, which are inserted into the dielectric protective tube 10 and lead out of the printed circuit board 5 of the endoscopic module A, are connected to the printed circuit board 5 by soldering by means of electrically conductive connections 6. Between the optical system 7, the imaging camera 3, the epoxy polymer cylinder 11 and the light-emitting diodes 4 there is an air gap 8 and the rest of the cavity within the capsule 1 is filled with a cured dielectric polymer 2. The truncated cone of the capsule 1 is modified so that the surface of the cone base on which the optical inlet of the capsule 1 is located is larger than the opposite cone base. The image from the gastrointestinal tract is transmitted via electrical wires from the capsule 1 to a display device for further processing.

Example No. 1

The swallow capsule endoscope for imaging of the esophagus shown in Figure No. 1 comprises a USB endoscopic module A having a maximum width of 6 mm and a length of 22 mm and consists of an imaging camera 3, the printed circuit board 5, the optical system 7 and light- emitting diodes 4. Electrical conductors 9 are soldered to the printed circuit board 5 of the endoscopic module A by means of electrically conductive connections 6, the diameter of each conductor being 100 micrometres. The electrical conductors 9 are inserted into the dielectric protective tube 10 and lead out of the printed circuit board 5 of the endoscopic module on the opposite side of that of the optical input of the endoscopic module A, which consists of the optical system 7 and the imaging camera 3. An epoxy polymer cylinder 11 having a width of 6 mm and a height of 2 mm is placed on the light-emitting diodes 4, and the epoxy polymer cylinder 11 is adhered by the epoxy to the light-emitting diodes 4. Thus, an air gap 8 is formed between the epoxy polymer cylinder 11, the optical system 7, the light-emitting diodes 4 and the imaging camera 3. The endoscopic module A with glued epoxy polymer cylinder 11 and soldered electrical conductors 9 is inserted into a silicone mould with a modified truncated cone shape with convex sides. The silicone cavity with the inserted endoscopic module A is filled with liquid epoxy, which encapsulates all the components of the endoscopic module. The epoxy is then allowed to cure. After the epoxide has cured, the silicone mould is removed to form a swallowable capsule 1 of a dielectric polymer 2 consisting of an epoxy from which the electrical conductors 9 are placed in the dielectric protective tube 10.

The invention is illustrated by the drawings in which Figure No. 1 shows: the capsule 1, the dielectric polymer 2, the imaging camera 3, the light-emitting diodes 4, the printed circuit board 5, the electrically conductive connection 6, the optical system 7, the air gap 8, the electrical conductors 9, the dielectric protective tube 10, the epoxy polymer cylinder 11, wherein the shape of the capsule 1 is a modified truncated cone having all sides convex.

Example No. 2

To create a swallow capsule endoscope for imaging the esophagus shown in Figure No. 2 and Figure No. 3, the same USB endoscopic module A is used as in the previous example, with the same wiring. Compared to the previous example, the difference in the preparation of the swallowable capsule 1 is that the endoscopic module with the adhered epoxy cylinder and electrical conductors 9 placed in the dielectric protective tube 10 is inserted into a silicone mold with a modified truncated cone shape. The cone has an upper and a lower base convex and a lateral side concave, or an upper and a lower base convex and a lateral side straight.

Figure No. 2 shows the capsule 1, the dielectric polymer 2, the imaging camera 3, the light- emitting diodes 4, the printed circuit board 5, the electrically conductive connection 6, the optical system 7, the air gap 8, the electrical conductors 9, the dielectric protective tube 10, the epoxy polymer cylinder 11. The shape of the capsule 1 is a modified truncated cone that has been modified so that the lower and upper bases of the modified truncated cone are convex and the sides of the modified truncated cone are concave.

Figure No. 3 shows the capsule 1, the dielectric polymer 2, the imaging camera 3, the light- emitting diodes 4, the printed circuit board 5, the electrically conductive connection 6, the optical system 7, the air gap 8, the electrical conductors 9, the dielectric protective tube 10, the epoxy polymer cylinder 11. The shape of the capsule 1 is a modified truncated cone that is modified so that the lower and upper bases of the modified truncated cone are convex and the sides of the modified truncated cone are straight.

Example No. 3

The same USB endoscopic module A as in the previous examples with the same wiring is used to create the swallow capsule endoscope for imaging the esophagus shown in Figure 4. Electrical conductors 9 are connected to the printed circuit board 5 of the endoscopic module by means of electrically conductive connections 6. The electrical conductors 9 are placed in a dielectric protective tube 10, which starts next to the light-emitting diodes 4. The dielectric protective tube 10 extends along the side of the USB endoscopic module and exits the endoscopic module on the opposite side to the optical input to the imaging camera 3. The endoscopic module with such guided dielectric protective tube 10 is inserted into a silicone mould with a cavity of the desired shape into which the endoscopic module A is placed and sealed with liquid epoxy. After the epoxy has cured, the epoxy capsule 1 with the cable is removed from the silicone mould.

Figure No. 4 shows the lead of the electrical conductors 9 from the capsule 1 in the dielectric protective tube 10. The beginning of the dielectric protective tube 10 is guided along the side of the capsule 1 and the electrical conductors 9 exit on the opposite side of that of the optical input to the imaging camera 3 of the capsule endoscope.

Example No. 4

The same USB endoscopic module A as in the previous examples with the same wiring is used to create the swallow capsule endoscope for imaging the esophagus shown in Figure No. 5. The beginning of the dielectric protective tube 10 is placed in close proximity to the electric conductive connections 6, and the dielectric tube is then routed along the side of the USB endoscopic module A. The dielectric protective tube 10 from the endoscopic module A extends on the same side as the optical input to the imaging camera 3. The endoscopic module A with such guided dielectric protective tube 10 is inserted into a silicone mould with a cavity of the desired shape in which the endoscopic module is placed and sealed with liquid epoxy. After the epoxy has cured, the epoxy capsule 1 with the cable is removed from the silicone mould.

Figure No. 5 shows the lead of the electrical conductors 9 from the capsule 1 in the dielectric protective tube 10. The beginning of the dielectric protective tube 10 is guided on the side of the capsule and the electrical conductors 9 exit on the same side as the optical input to the imaging camera 3 of the capsule endoscope. INDUSTRIAL APPLICABILITY

Swallow capsule endoscopes can be used in the field of medicine, in gastroenteorology to visualize the esophagus while checking its functionality and the effectiveness of the treatment of its diseases.

LIST OF REFERENCE SIGNS

1 capsule

2 dielectric polymer

3 imaging camera

4 light-emitting diodes

5 printed circuit board

6 electrically conductive connection

7 optical system

8 air gap

9 electrical conductors

10 dielectric protective tube

11 epoxy polymer cylinder

A endoscopic module

INCORPORATED BY REFERENCE (RULE 20.6)

Claims

P A T E N T C L A I M S

1. Swallow capsule endoscope characterized by the fact that it comprises a modified truncated cone-shaped cavity capsule (1) in which an endoscopic module (A) is inserted, comprising an optical data transmission input formed by an optical system (7) connected to the imaging camera (3) and the imaging camera (3) on the other side is connected to the printed circuit board (5), the optical system (7) has side-mounted light-emitting diodes (4) to which the epoxy polymer cylinder (11) is adhered by the epoxy glue and to the printed circuit board (5) are connected by soldering by means of electrically conductive connections (6) electrical conductors (9), which are inserted into the dielectric protective tube (10) and are led from the printed circuit board (5) of the endoscopic module (A) and between the optical system (7), the imaging camera (3), the epoxy polymer cylinder (11) and the light-emitting diodes (4) is an air gap (8), and the rest of the cavity inside the capsule (1) is filled with cured dielectric polymer (2) while the truncated cone of the capsule (1) is modified so that the surface of the cone base on which the optical input of the capsule (1) is located is larger than the surface of the opposite cone base.

2. Swallow capsule endoscope according to claim 1 characterized by the fact that the capsule (1) has the shape of a modified truncated cone, all sides of which are convex.

3. Swallow capsule endoscope according to claim 1 characterized by the fact that the capsule (1) has the shape of a modified truncated cone, wherein the lower and upper bases of the modified truncated cone are convex and the lateral side of the modified truncated cone is concave.

4. Swallow capsule endoscope according to claim 1 characterized by the fact that the capsule (1) has the shape of a modified truncated cone, wherein the lower and upper bases of the modified truncated cone are convex and the lateral side of the modified truncated cone is straight.

5. Swallow capsule endoscope according to claims 1 - 4 characterized by the fact that the dielectric protective tube (10) is guided along the lateral side of the capsule (1), wherein the beginning of the dielectric protective tube (10) is embedded in the dielectric polymer (2) and the electrical conductors (9) guided in the dielectric protective tube (10) extend from the capsule (1) on the opposite side of the optical input of the endoscopic module (A).

6. Swallow capsule endoscope according to claims 1 - 4 characterized by the fact that the dielectric protective tube (10) is guided along the lateral side of the capsule (1), wherein the beginning of the dielectric protective tube (10) is embedded in the dielectric polymer (2) and the electrical conductors (9) guided in the dielectric protective tube (10) extend from the capsule (1) on the same side as the optical input of the endoscopic module (A).