Patent Application
20220280029
The invention relates to an endoscope for inspection and study of the gastrointestinal tract, especially the human small intestine.
There is a growing body of evidence suggesting a link between intestinal microbiota and disease. However, current research is severely limited because there is no good way to access or inspect the whole length of the small intestine. The large intestine is relatively easy to access and inspect with modern endoscopic devices, but the inspection of the small intestine, also called the small bowel, poses major anatomical challenges that have yet to be overcome. It is currently very difficult for Gastroenterologists to examine or treat the entirety of the small intestine. While the first 1-2 meters are usually accessible using classical push-endoscopy techniques, the remaining 3-4 meters are notoriously difficult to access non-invasively. Several technologies, such as double balloon endoscopy (DBE) and spiral endoscopy (SE), have tried to address this issue with limited success. Although these techniques offer some benefits over traditional push endoscopy, they are complex, time-consuming and are still unable to reliably access the entire small intestine.
It is an object of the present invention to provide an endoscope for the inspection and study of the small intestine, which can be used to traverse the greater part or even the entire small intestine in a safe, reliable and reproducible manner.
This objective is met according to the present invention by providing a device with the features of claim 1. Further advantageous embodiments of the invention are the subject of the sub-claims.
Unlike traditional endoscopes, the proposed concept does not rely on an external proximal pushing force to make progress. Instead, a flexible tubular structure is rotated proximally, and this rotation is gradually propagated through the tubular structure to the distal end of the tubular structure, even through sharp curves and over long distances. An elongated element extends through the distal tip of the tubular structure and connects to an endoscopic tip. The elongated element is rotationally coupled to the tubular structure such that when the tubular structure is rotated in a first direction, the elongated element is translated forward and a gap between the distal end of the tubular structure and the endoscopic tip is increased. The endoscopic tip, which is touching the intestinal wall, is thus moved forward further into the small intestine. A rotation of the tubular structure in a second rotational direction translates the elongated element backwards and decreases the gap between the distal end and the endoscopic tip, thereby causing the proximal portions of the tubular structure to travel forward along the elongated element and towards the endoscopic tip. The entire endoscope thus makes forward progress by repeatedly rotating the tubular structure in alternating rotation directions.
With this feature, the proposed endoscope provides means to access the entire length of the small intestine quickly and easily, without undue complexity for the physician and with minimal discomfort for the patient.
To convert rotation of the tubular member into linear motion of the endoscope tip, the endoscope comprises an elongated, flexible tubular structure and a flexible, elongated element disposed inside the tubular structure such that a distal portion of the elongated element protrudes from a distal end of the tubular structure and is connected to the endoscopic tip. The elongated element and the tubular structure may in particular be arranged coaxially or substantially coaxially.
Herein, the expressions proximal and distal are used with respect to the position of the physician utilizing the endoscope. The expression distal thus describes parts, sections or directions that are oriented or placed towards the inside of the patient's body, where the physician cannot manipulate the parts directly with his hands. Likewise, the expression proximal stands for the parts, sections or directions positioned at or oriented towards the location of the physician.
An endoscopic tip is attached to the distal end of the elongated element, and the elongated element is engaged with the tubular structure such that a rotation of the tubular structure around the elongated element in a first rotation direction will increase the gap between the distal end of the tubular structure and the endoscopic tip. Correspondingly, a rotation of the tubular structure around the elongated element in a second rotation direction, opposite to the first rotation direction, will decrease the gap between the endoscopic tip and the tubular structure's distal end. The first rotation direction may be a counterclockwise direction, in which case the second rotation direction is a clockwise direction. Alternatively, the first rotation direction may be a clockwise direction, in which case the second rotation direction is a counterclockwise direction.
The physician utilizing the endoscope will hold a proximal portion of the tubular structure and rotate it alternately in a counterclockwise and a clockwise direction while navigating the small intestine of the patient. Because of the engagement between the elongated element and the tubular structure, this will cause the elongated element to move back and forth along the length of the tubular structure, alternately increasing and decreasing the gap between the endoscopic tip and the distal end of the tubular structure. The endoscopic tip will thus be pushed forward during the first half of the rotation cycle and the tubular structure will be pulled toward the now advanced endoscopic tip during the next half of the rotation cycle.
A gentle bias, i.e. a small pushing force, may be applied to the proximal end of the tubular structure during the rotation cycle. Due to the longitudinal flexibility (compressibility) of the tubular structure, this force causes the proximal portions of the tubular structure to be compressed. This compression propagates through the tubular structure during rotation and encourages the forward motion of the distal end of the tubular structure. Even though regular pushing may not be effective, a rotation of the tubular structure causes a constant stick-slip phenomenon on the intestinal wall, allowing small sections of the tubular structure to intermittently make forward progress. Other cumulative or alternative effects for causing or enhancing the forward movement of the endoscope due to this alternating rotation will be explained further below.
Advantageously, the elongated element passes freely through an inner lumen of the tubular structure, and is attached to the tubular structure only by means of the rotational engagement mechanism described above. In particular, the elongated element is not limited in its range of linear motion by its attachment to the tubular structure. Preferably, the gap between the endoscopic tip and the distal end is exposed, in particular exposed to the environment inside the small intestine.
According to a preferred embodiment, engagement between the elongated element and the tubular structure is by way of an engaging element engaging with a thread structure or a helical structure. In particular, the engaging element, such as a protruding element like a pin, peg, or bearing ball, may reach into the threads of the thread structure in order to translate a rotation of the tubular member into a translational movement of the elongated element with respect to the engaging element.
The thread structure in a preferred embodiment may be a thread formed on an outside surface of said elongated element. In this case, the engaging element must be attached to the tubular structure. Alternatively, the thread structure may be a thread formed on an inside surface of the tubular structure or otherwise be attached to the tubular structure and the engaging element may be attached to the elongated element, preferably to its outside surface.
In advantageous embodiments, said engagement between the elongated element and the tubular structure may be effected at two or more positions along the length of the elongated element and/or the tubular structure. If the engagement is accomplished with a helical or thread structure, there might therefore be more than one engagement element placed along the threaded structure. Alternatively, the engagement element could also be a second threaded or helical structure interlocking with the threaded or helical structure over a certain length.
In one embodiment, the tubular structure also includes an outer spiraling surface structure. In other words, the outside surface of the tubular structure has a groove or a ridge that spirals along the length of the tubular structure. The spiraling surface structure may be made of one or several such groove(s) or ridge(s). The spiraling surface structure may be formed over a distal section, over a major part, or over substantially all of the tubular structure. Said spiral surface structure of the tubular structure may act similar to a screw by engaging with the intestinal wall during rotation. Consequently, it can provide a further forward bias during rotation, in order to propel the distal end towards the endoscopic tip during rotation in the second rotation direction.
A further way of facilitating the scope's forward movement is to form the endoscopic tip such that it experiences less frictional resistance when being pushed forward than when pulled backward inside the intestine. Thus, the increasing gap between the endoscopic tip and the distal end of the tubular structure will tend to push the endoscopic tip forward within the intestine, while the decreasing gap between the endoscopic tip and the distal end will tend to draw the tubular structure along the intestine forward towards the endoscopic tip, instead of pulling the endoscopic tip back towards the tubular structure.
The endoscopic tip may in a preferred embodiment have substantially the same diameter as the distal end of said tubular structure, at least at the proximal end of the endoscopic tip, i.e. at the end that abuts the distal end when in a completely retracted position.
Preferably, the endoscope is designed such that when the endoscopic tip is in a completely retracted position, in which the endoscopic tip is abutting the distal end of the tubular structure, a seal is formed between said endoscopic tip and said distal end, sealing an inner lumen of said tubular structure distally, such that substantially no liquid or gas can enter or leave the inner lumen at the distal end.
Besides facilitating the forward movement of the endoscope, the endoscopic tip may contain instruments that aid in the inspection of the small intestine. For example, the endoscopic tip may contain a camera, in particular an endoscopic camera for inspection of the gastro-intestinal tract. Furthermore, lights may be positioned on the endoscopic tip in order to illuminate the intestine for allowing image and video capture with the camera. Another instrument might be an electrode, in particular an electrode disposed on the proximal side of the endoscopic tip. A corresponding counter-electrode may in this case be disposed on the distal-most part of the distal tip of the tubular structure. The electrodes may in particular be used for measuring impedances or potentials. The endoscopic tip may also contain a means for remotely steering the tip, for example a permanent magnet designed to be manipulated with external magnetic fields. The endoscopic tip may also contain a means for sampling the epithelial tissue of the intestinal wall.
Wires for the camera, lights and/or the electrode may run from the endoscopic tip through a central lumen of the elongated element to a proximal end of the endoscope. The second electrode on the distal end, if provided, may be electrically connected to a wire running along or inside a wall of the tubular structure. In particular, it may be part of a reinforcement or spiral reinforcement of the tubular structure wall.
In the embodiment with the first electrode on the proximal side of the endoscopic tip and the second electrode on the distal end of the tubular structure, such that the two electrodes are separated by the gap between the endoscopic tip and the distal end, transepithelial impedance may be measured by advancing the tubular structure until a portion of the intestinal wall is sandwiched between the two electrodes. Then the impedance between the two electrodes is measured, the value of which corresponds to twice the transepithelial impedance. For this impedance measurement, a low pressure or vacuum may be applied to the inner lumen of the tubular structure, causing air to be sucked into the inner lumen from the gap between the endoscopic tip and the tubular structure's distal end, thus pulling the intestinal wall into the gap. For this purpose, it is advantageous that the distal end of the inner lumen of the tubular structure is not sealed or not completely sealed from the outside, at least as long as the endoscopic tip is not completely retracted.
In advantageous embodiments, the endoscope includes one or more actuation and/or sensory module(s). The module or modules may be located at one or multiple positions along the length of the tubular structure. If multiple modules are provided, they may be arranged at certain distance intervals along the length of said tubular structure, preferably at regular intervals, in particular along the entire length of the tubular structure. Modules of the same sort, e.g. biopsy sampling modules, may be arranged at regular intervals of between 15 cm and 30 cm, in particular between 20 cm and 25 cm. In this case, there may be between 18 and 36, advantageously between 24 and 30, such modules provided along a 6 m length of the tubular structure. Modules of different sorts may also be arranged in any order along the length of the tubular structure. These modules may be permanently fixed to the tubular structure, or may be modular (i.e. able to be removed and replaced with other modules). In this way, different modules may be arranged in a variety of ways for specific purposes or procedures. Alternatively or in addition, one or more specific modules that are specifically designed to detachably connect separate sections of the endoscope together may be provided.
The module or modules may be actuated mechanically, electrically and/or hydraulically/pneumatically. Two, multiple or all of the modules may be actuated simultaneously by the same triggering event. In particular, all modules of the same sort may be actuated simultaneously.
Preferably, the actuation and/or sensory module(s) is/are from the following group: A biopsy sampling module, an impedance measurement module, a drug or fluid delivery or distribution module, a camera module, a handling module for holding or driving the endoscope, or any combination thereof. The term “any combination thereof” may in this regard mean that a single module has multiple functions integrated into it, such as a drug delivery module which contains a camera for more exactly pinpointing the site of drug delivery. That term may, however, also mean that there are modules with different functions placed at distances along the tubular structure.
The biopsy sampling module is configured to extract a biopsy of epithelial tissue from the intestinal wall. For this purpose, in one embodiment, the sampling module comprises a central shaft, a sampling wheel, a sampling module, a torsion spring, a protective casing, a piston, a piston spring, and an endcap. For purposes of sterility, the sampling module may be disposable. Alternatively, the sampling module may be reusable after a sterilization process. The central shaft may be fixed to the tubular structure and have a lumen through which the elongated element passes. This lumen of the sampling module may be in fluid contact with the inner lumen of the outer tubular structure. The torsion spring is engaged with the central shaft, as well as with the sampling wheel, which is free to rotate around the central shaft. The sampling wheel has a cutout into which a disposable sample holder may be inserted and removed.
The disposable sample holder may consist of a receptacle where the sample is stored, and a blade or brush with which the biopsy is obtained. The casing is fixed to the central shaft and surrounds the sampling wheel, guarding the disposable sample holder when not in use. The casing further has a cutout to allow the sampling blade or brush to contact the tissue when the unit is triggered. The piston is fitted around the central shaft just behind the sampling wheel and is free to move linearly. The piston spring pushes the piston up against the sampling wheel, locking the sampling wheel in place.
When the sample lumen of the sampling module is pressurized, holes in the central shaft allow the air to push the piston back against the piston spring, releasing the sampling wheel and causing the biopsy to be taken. At the end of its stroke, the sample holder has rotated by approximately 180 degrees and is now protected from contamination by the other side of the casing. When the pressure is released, the piston returns to its original position, fixing the sampling wheel in its final position. The endcap is fixed to the central shaft as well as the tubular structure.
The impedance measurement module is configured to measure transepithelial impedance, transepithelial resistance or transepithelial electric potential. For this purpose, it may have one, two or multiple electrodes for contacting the intestinal wall. The drug or fluid delivery or distribution module is configured for localized delivery of a medication or any other substance (e.g. probiotics, microrobots, fluorescent dye, contrast agent etc.) inside the intestine. In addition to or instead of the endoscopic camera placed at the endoscopic tip, one or more camera modules may be provided along the length of the endoscope, facing the intestinal wall. The camera of such a camera module may comprise an image sensor and a clear casing and be configured to take video or still images. As the tubular structure rotates, so will the image sensor, allowing for full 360 imaging of the intestinal wall. The handling module may provide sections that can be engaged with a tool, such as an automatic wrench, which can then aid in rotating and/or pushing the tubular structure, while the handling module is outside of the intestine. For example, the handling module may have one, two or multiple flat sections, on which a wrench or any other suitable tool can be engaged.
According to advantageous embodiments, some of the modules may be pneumatically or hydraulically actuated. In particular, one, multiple or all of said modules may be activated by a change of pressure in an inner lumen of said tubular structure.
In a preferred embodiment, a proximal end of said elongated element extends proximally through a sliding seal and beyond a proximal end of said tubular structure. The sliding seal ensures that the elongated element and tubular structure can move relative to each other without compromising the sealed internal volume of the tubular structure. The elongated element may thus be manipulated manually by the physician from the proximal side of the tubular structure, which is facing the physician. Alternatively, the proximal end of said elongated element may be positioned inside said tubular structure. This means in particular that the elongated element is shorter, potentially much shorter than the tubular structure.
Some examples of embodiments of the present invention will be explained in more detail in the following description with reference to the accompanying schematic drawings, wherein:
An elongated element 22 runs through the inner lumen 11 of the tubular structure 10, and through the distal opening 13, ending in an endoscopic tip 3. The elongated element 22 is rotationally engaged with the tubular structure 10 such that a relative rotation of the elongated element 22 and the tubular structure 10 will result in a corresponding linear movement between the elongated element 22 and the tubular structure 10 along a joint longitudinal axis.
For providing the rotational engagement, the elongated element 22 is surrounded by a thread structure 2, in particular a spiraling wire, attached to a tube. The tube itself may also be made of a spiraling wire, which is more densely packed than that of the thread structure 2. There is an engaging element in the form of a bearing ball 18 placed inside the distal end 14 of the tubular structure 10. The bearing ball 18 engages with the thread structure 2 to translate rotational movement of the tubular structure around the longitudinal axis into linear or translational movement of the elongated element along the longitudinal axis. The bearing ball 18 is held inside the distal end 14 by a sleeve 16.
The movement of the elongated element 22 with respect to the tubular structure 10 along the longitudinal axis causes the endoscopic tip 3 to move in the same fashion with respect to the tubular structure 10. When the elongated element 22 is retracted as far as possible into the tubular structure 10, the endoscopic tip 3 is in a retracted position (not shown in the figures). In this position, it will cover the opening 13, and, if so configured, also seal the inner lumen 11 at the opening 13, allowing the inner lumen 11 to be pressurized or depressurized. Alternatively, the distal opening 13 may be a sliding seal, which ensures that the inner lumen 11 is sealed against the outside even when the endoscopic tip 3 is not in the retracted position.
When the tubular structure 10 is rotated in one direction (e.g. counterclockwise), the rotational engagement causes the endoscopic tip 3 to move forward, away from the distal end 14. In
As in all embodiments shown in the
The endoscopic tip 3 comprises a camera 32, which is configured to take images or video images of the inside of the intestine. The images may be sent in digital form via wireless connection to an outside device, such as a computer. Alternatively, the camera may be connected via wires, which may run through a central lumen 23 of the elongated element 22. The three embodiments of the endoscope have such wires running through the central lumen 23, as can be seen in
The elongated element 22 of the endoscope shown in
As can be seen in
An endoscope according to a second embodiment is shown in
In this embodiment, the thread structure 2 is only provided on a distal section of the elongated element 22, and thus ends within the inner lumen 11 of the tubular structure 10. As the thread structure 2 only serves for providing the rotational engagement between the tubular structure 10 and the elongated element 22, it is not necessary that it extends much beyond the engagement element 18 at the most possible or practical extension position of the endoscopic tip 3. This is also the case for the endoscope according to the third embodiment shown in
The endoscopic tip 3 of each of the endoscopes shown in
Each of the endoscopes shown in
The endoscopic tips 3 shown in the embodiments in
Alternatively, the fluid or drug to be released may be pumped through the inner lumen 11 and flow out of the distribution module 52 or out of some or all of the distribution modules 52, in case more than one such module 52 is provided.
The sensory module shown in
A preferred embodiment of a biopsy sampling module 4 is shown in a cross-sectional view in
The disposable sample holder (not shown in the figures) comprises a receptacle where the sample is stored, and a blade or brush with which the biopsy is obtained. The casing 47 surrounds the sampling wheel 44, guarding the disposable sample holder when not in use and protecting the sample holder from cross-contamination both before and after the sampling occurs. The casing 47 further has a cutout to allow the sampling blade or brush to contact the tissue when the module 4 is triggered. The piston 45 is fitted around the central shaft 42 just behind the sampling wheel 44 and is free to move linearly along the shaft axis. The piston spring 46 pushes the piston 45 up against the sampling wheel 44, locking the sampling wheel 44 in place. The piston 45 has a pin (not shown) to prevent the rotation of the sampling wheel 44.
When the lumen of the sampling module 4 is pressurized, holes in the central shaft 42 allow the air to push the piston 45 back against the piston spring 46, releasing the sampling wheel 44 and causing the biopsy to be taken. At the end of its stroke, the sample holder has rotated by approximately 180 degrees and is now protected from contamination by the other side of the casing 47. When the pressure is released, the piston 45 returns to its original position, fixing the sampling wheel 44 in its final position. Pressurizing and depressurizing the
sampling module 4 in order to displace the piston 45 is performed by pressurizing and depressurizing the inside lumen 11 of the tubular structure 10 by way of the inlet 62. The endcap 48 is fixed to the central shaft 42 as well as to the tubular structure 10.
The endoscope is equipped with a number of sampling modules 4 periodically disposed along its length for the purpose of obtaining biopsies or scrapings of the epithelial tissue. These sampling modules 4 are pre-loaded and can be triggered simultaneously, ensuring that biopsies are taken at regular distance intervals along the intestine. The biopsy sampling modules 4 may for example be arranged at regular intervals of between 20 cm and 25 cm. In this case, there may be between 24 and 30 such modules provided along a 6 m length of the tubular structure 10.
| Number | Date | Country | Kind |
|---|---|---|---|
| 19190493.7 | Aug 2019 | EP | regional |
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2020/071978 | 8/5/2020 | WO |
