WO2023105539A1 - An improved overtube - Google Patents

Abstract

An improved overtube device (100) comprising: a channel (12), with an internal wall (12a) and an external wall (12b), said channel being configured to allow an endoscope to passed through it, said channel (12) forming an over-tube over said endoscope, said channel (12) forming a guiding template, and a protective wall, to guide said endoscope to various places, in situ; directionally and with appropriate traction; at least a first opening (14a), at an operative distal end of said channel (12); and plurality of circumferentially located additional channels (32, 34, 36, 38) in a spaced apart region between said walls (12a, 12b) of said overtube (100), each of said additional channels (32, 34, 36, 38) being, circumferentially, dispersed about said channel (12), said additional channels having proximal entry ports and running through the length of said overtube (100).

Description

AN IMPROVED OVERTUBE

FIELD OF THE INVENTION:

This invention relates to the field of biomedical engineering.

Particularly, this invention relates to an improved overtube.

BACKGROUND OF THE INVENTION:

In many surgical procedures, especially ones which use minimally invasvive tools such as scopes, catheters, laparoscopic instruments, and the like, accessing an organ, in situ, is problematic if the path of travel for such tools and instruments comprise curves and turns.

One such typical procedure is ‘cholangioscopy’. Cholangioscopy is, primarily, used for treatment of difficult bile duct stones the evaluation of biliary strictures. In a typical cholangioscopy procedure, there are at least three changes in direction that a scope needs to undergo and a variety of push tractions need to be enforces to enforce such changes in directions; this makes the procedure significantly tricky.

In the prior arts, a paediatric endoscope was used for direct Per oral Cholangioscopy; however, these endoscopes are loose and cannot be used efficiently in adults.

Furthermore, in procedures which involve passage through the stomach, the scope coils up since the stomach is a wide organ; therefore, gain is less and play is more. Furthermore, in procedures which involve passage through the stomach, the scope curls since the duodenum is a curled organ; therefore, further traversal is difficult.

Furthermore, in procedures, typically, relating to cholangioscopy, the passage comprises change of angle which is more than 90 degrees; therefore, the scope, of the prior art, curls.

In certain other prior art documents, a balloon catheter was developed and used; however, such a balloon catheter engages the central catheter completely leaving little to no room for other tools to pass through.

Therefore, there is a need for an improved overtube which alleviates all the aforementioned problems.

OBJECTS OF THE INVENTION:

An object of the invention is to form a template, at various levels, in a body, during medical procedures, so as to direct an endoscope / surgical tools towards a desired location or direction within the body.

Another object of the invention is to provide an instrument / overtube which traverses a variety of directional changes, in situ, in a simple and ergonomic fashion.

Yet another object of the invention which facilitates active traction deployment to cause change in direction while the tool / instrument is traversing its path in situ.

SUMMARY OF THE INVENTION: According to this invention, there is provided an improved overtube comprising:

- a channel, with an internal wall and an external wall, said channel being configured to allow an endoscope to passed through it, said channel forming an over-tube over said endoscope, said channel forming a guiding template, and a protective wall, to guide said endoscope to various places, in situ; directionally and with appropriate traction;

- at least a first opening, at an operative distal end of said channel; and

- plurality of circumferentially located additional channels in a spaced apart region between said walls of said overtube, each of said additional channels being, circumferentially, dispersed about said channel, said additional channels having proximal entry ports and running through the length of said overtube.

In at least an embodiment, said overtube comprising a tubular structure through which a tube lumen pediatric endoscope is passed.

In at least an embodiment, said channel comprises two openings at its operative distal end, in that, said openings being:

- a first opening at an operative distal end of said channel; and

- a second opening, preceding said first opening by a pre-defined distance, at an operative distal end of said channel.

In at least an embodiment, said channel comprises two openings at its operative distal end, in that, said openings being:

- a first opening being an axial distal opening; and

- a second opening being a side distal opening. In at least an embodiment, said plurality of channels being at least four circumferentially located additional channels, in that, a first channel being configured to receive stiff wires (rigid rods) which run through the length of said additional channels and said overtube in order to ensures that said overtube does not become floppy.

In at least an embodiment, said plurality of channels being at least four circumferentially located additional channels, in that, a second channel being configured to receive wires which run through the length of said additional channels and said overtube in order to ensures that said overtube does not become floppy.

In at least an embodiment, said plurality of channels being at least four circumferentially located additional channels, in that, a third channel being configured to receive a flap thread, such that a thread runs through said third channel and ends at said first opening where a flap is located, said flap being tied to said thread and said flap configured to be moved based on said thread’s pull, said flap being coupled to an inside wall of said overtube.

In at least an embodiment, said plurality of channels being at least four circumferentially located additional channels, in that, a fourth channel being configured to receive a first balloon being configured to inflate, through said first opening, said first balloon being coupled to an outside wall of said overtube.

In at least an embodiment, said device comprising a second balloon within said channel, at a distal end of said channel, at a first opening and beyond said second opening, said second balloon acting as a second, alternative, mechanism to ensure that said endoscope is blocked from going straight through said distal first opening by inflating said second balloon into the lumen of said channel distal to said second opening, said second balloon being coupled to an inside wall of said overtube.

In at least an embodiment, an operative distal end of said first outer channel having two openings; one opening at an operative distal end and another opening at a location just proximal to said balloon.

In at least an embodiment, said overtube comprising a plurality of additional channels, in that,

- each of said additional channels being, circumferentially, dispersed about said second outer channel;

- each of said additional channels having a proximal entry port; and

- each of said additional channels running through a length of said overtube device.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:

The invention will now be described in relation to the accompanying drawings, in which:

FIGURE 1 illustrates a side view of this improved overtube;

FIGURE 2 illustrates a transverse-axis sectional view of this improved endoscope; FIGURE 3 A illustrates a front view of this improved overtube, of Figure 1 , with its flap and first balloon;

FIGURE 3B illustrates a back view of this improved overtube, of Figure 1 , with its flap and first balloon; FIGURE 3C illustrates a side view of this improved overtube, of Figure 1, with its flap and first balloon;

FIGURE 4A illustrates a front view of this improved overtube, of Figure 1 , with its first balloon and second balloon;

FIGURE 4B illustrates a back view of this improved overtube, of Figure 1 , with its first balloon and second balloon; and

FIGURE 4C illustrates a side view of this improved overtube, of Figure 1, with its first balloon and second balloon.

FIGURE 5A illustrates a cross-section view of a distal end of the improved overtube where an inflated inside balloon and an inflated outside balloon is seen; and

FIGURE 5B illustrates a cross-section view of a distal end of the improved overtube where a deflated inside balloon is seen.

DETAIUED DESCRIPTION OF THE ACCOMPANYING DRAWINGS: According to this invention, there is provided an improved overtube.

FIGURE 1 illustrates a side view of this improved overtube.

In at least an embodiment, of this invention, the improved overtube (100) comprises a channel (12) with an internal wall (1 a) and an external wall (12b). Through this channel (12), an endoscope is passed. Thus, the walls of the channel (12) form an over-tube or a sheath over the endoscope, which can pass through the channel (12), and the channel (12) form a guiding template, as well as a protective wall, in order to guide the endoscope to various places, in situ; directionally and with appropriate traction. In at least an embodiment, of this invention, the overtube (100) comprises a tubular structure, i.e. channel (12), through which, in some embodiments, a tube lumen pediatric endoscope is passed having diameter, preferably, of 5mm. Preferably, the overtube has a diameter of 9 to 10mm.

In at least an embodiment, the channel (12) comprises two openings (14a, 14b) at its operative distal end. A first opening (14a) is at the distal end of the channel (12) and a second opening (14b), precedes the first opening by a pre-defined distance, is also at the distal end of the channel (12). Typically, the first opening (14a) is an axial opening. Typically, the second opening (14b) is a side opening.

FIGURE 2 illustrates a transverse-axis sectional view of this improved endoscope.

In at least an embodiment, the channel (12) comprises four circumferentially located additional channels (32, 34, 36, 38) in the spaced apart region between the walls (12a, 12b) of the overtube (100). Each of these additional channels (32, 34, 36, 38) are, circumferentially, dispersed about the channel (12). These additional channels have proximal entry ports and run through the length of the overtube (100).

Typically, a first channel (32) and a second channel (34) are configured to receive stiff wires (rigid rods) which run through the length of the additional channels and the overtube (100); depending on where (stomach or duodenum) the overtube should reach / pass. This ensures that the overtube (100) does not become floppy. In the first channel (32), a stiff guide wire, a metal rod is inserted till pyloric opening which give stiffness to esophagogastric segment.

In the first channel (34), a stiff guide wire / metal rod is inserted till opening of bile duct in duodenum to give stiffness to duodenal segment.

Typically, a third channel (36) is configured to receive a flap (36a) and thread (36b), such that a thread runs through the third channel (36) and ends at the first opening (14a) where a flap is located. When the thread is pulled, the flap which directs the endoscope towards the first opening (14a), or towards the second opening (14b), as per requirement. The thread provides a direction guide for changes to the endoscope which changes are more than 90 degrees. At distal end, there is flap at the level of side opening which guides endoscope on front side or lateral side. Preferably, the flap is connected or stuck to an inside wall of the overtube (100) and is distal to the side opening.

Typically, a fourth channel (38) is configured to receive / blow into a first balloon (20) which holds the overtube (100) in place where required and the balloon (20) is configured to inflate, through the first opening (14a), or through the second opening (14b), as and how required. Preferably, the first balloon (20) is incorporated in an outside wall of the overtube (100).

This mechanism, of the invented overtube (100) ensures that there is support from outside additional channels while the inner channel (12) remains free.

FIGURE 3A illustrates a front view of this improved overtube, of Figure 1 , with its flap (36a) and first balloon (20). FIGURE 3B illustrates a back view of this improved overtube, of Figure 1 , with its flap (36a) and first balloon (20).

FIGURE 3C illustrates a side view of this improved overtube, of Figure 1, with its flap (36a) and first balloon (20).

In at least another embodiment, there is provided a second balloon (30) within the channel (12), at a distal end of the channel (12), at the first opening (14a) and beyond the second opening (14b). This second balloon (30) acts as a second, alternative, mechanism to ensure that the endoscope is blocked from going straight through the distal first hole (14a) by inflating the second balloon (30) into the lumen of the channel (12) distal to the second opening (14b). The second balloon (30), in the lumen, is inflated by instilling air (38a) through a port instead of thread and flap assembly. This ensures that the endoscope passes through the side second hole (14b) only. Preferably, the second balloon (30) is incorporated in an inside wall of the overtube (100).

FIGURE 4A illustrates a front view of this improved overtube, of Figure 1 , with its first balloon (20) and second balloon (30).

FIGURE 4B illustrates a back view of this improved overtube, of Figure 1 , with its first balloon (20) and second balloon (30).

FIGURE 4C illustrates a side view of this improved overtube, of Figure 1, with its first balloon (20) and second balloon (30).

FIGURE 5A illustrates a cross-section view of a distal end of the improved overtube where an inflated inside balloon (30) and an inflated outside balloon (20) is seen. FIGURE 5B illustrates a cross-section view of a distal end of the improved overtube where a deflated inside balloon (30) is seen.

Typically, the overtube (100) acts as a guiding channel for the pediatric endoscope, passing through it, and forms a guiding template wall as a protective wall in order to guide the endoscope towards various places, in situ, directionally and with appropriate traction.

In at least an embodiment, of this invention, the overtube (100) is of a length such that it can traverse a human body’s esophagogastric section, duodenal section, and ductal section. It is to be noted that even though this overtube is defined in terms of sections, there are no visible or distinct sections; in fact, the overtube is a single contiguous tube. The ‘sections’ per se are not visible plainly but can be understood in the context of portions of human body when the overtube is inserted for procedures such as cholangioscopy.

One or more stiff guide wires can be inserted in the additional channels to keep a portion of the overtube (100) substantially straight. This stiff guide wire is such that is provides stiffness along with flexibility thereby forming a curvilinear shape to a section as and when required. A further portion of the overtube, when in-situ, also extends from the pylorus to sphincter, crossing the stomach, therebetween. This portion, when in-situ, is a substantially, curved section. Here, the stiff guide wire, in the additional channel, prevents bending of the overtube (100). A further further portion of the overtube, when in-situ, also extends from the duodenum through the sphincter, to the common bile duct. When in-situ, this is the most curved section, at its proximal end and straight at its distal end. In at least an embodiment related to method of working of the overtube, of this invention, the following steps may, generally, be practiced:

- instill NS into overtube (100) to make it wet;

- lubricate pediatric endoscope with jelly for whole extent

- insert endoscope (100) into over tube till end protrudes out of overtube;

- insert endoscope (100)and overtube assembly into oral cavity and go to duodenum till end of second part;

- insert guidewire / rod into one channel (32/ 34) till duodenum under C-Arm guidance to straighten the course of over tube and endoscope;

- withdraw endoscope till lateral opening of overtube - the flap will be pushed automatically into closed position;

- in a modified, alternative version, of the overtube, of this invention, instead of flap, a second balloon is incorporated distal to proximal opening - here, second balloon is kept in deflated position when scope is inserted till duodenum - once inside the duodenum, the scope is withdrawn proximal to side opening and the second balloon is inflated to block the lumen so that the scope is directed laterally through the side opening;

- visualize ampulla;

- insert guidewire into CBD through ampulla;

- inflate balloon with air to fix tube in position;

- insert endoscope (100) into ampulla over guidewire.

The INVENTIVE STEP, of this invention, lies in its ability to provide a sheath / overtube which has differential flexibility as well as with rigidity.

The overtube (100), of this invention, is especially important for endoscopy of smaller tubes in deep places like biliary tree, pancreatic duct system, and the like. This is especially suitable for cholangioscopy and Pancreatoscopy where there are multiple abrupt changes in direction and rigidity and support.

The TECHNICAL ADVANCEMENT of this invention lies in providing an improved overtube that can be used in tricky places; thus, allowing the scope to traverse through various anatomical challenges. This invention’s geometry is designed in order to guide the overtube (100), of this invention to various places, in situ; directionally and with appropriate traction

While this detailed description has disclosed certain specific embodiments for illustrative purposes, various modifications will be apparent to those skilled in the art which do not constitute departures from the spirit and scope of the invention as defined in the following claims, and it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

Claims

CLAIMS,

1. An improved overtube device (100) comprising:

- a channel (12), with an internal wall (12a) and an external wall (12b), said channel being configured to allow an endoscope to passed through it, said channel (12) forming an over- tube over said endoscope, said channel (12) forming a guiding template, and a protective wall, to guide said endoscope to various places, in situ; directionally and with appropriate traction;

- at least a first opening (14a), at an operative distal end of said channel (12); and

- plurality of circumferentially located additional channels (32, 34, 36, 38) in a spaced apart region between said walls (12a, 12b) of said overtube (100), each of said additional channels (32, 34, 36, 38) being, circumferentially, dispersed about said channel (12), said additional channels having proximal entry ports and running through the length of said overtube (100).

2. The device (100) as claimed in claim 1 wherein, said overtube comprising a tubular structure through which a tube lumen pediatric endoscope is passed.

3. The device (100) as claimed in claim 1 wherein, said channel (12) comprises two openings (14a, 14b) at its operative distal end, in that, said openings being:

- a first opening (14a) at an operative distal end of said channel (12); and

- a second opening (14b), preceding said first opening by a pre-defined distance, at an operative distal end of said channel (12). The device (100) as claimed in claim 1 wherein, said channel (12) comprises two openings (14a, 14b) at its operative distal end, in that, said openings being:

- a first opening (14a) being an axial distal opening; and

- a second opening (14b) being a side distal opening. The device (100) as claimed in claim 1 wherein, said plurality of channels being at least four circumferentially located additional channels (32, 34, 36, 38), in that, a first channel (32) being configured to receive stiff wires (rigid rods) which run through the length of said additional channels and said overtube (100) in order to ensures that said overtube (100) does not become floppy. The device (100) as claimed in claim 1 wherein, said plurality of channels being at least four circumferentially located additional channels (32, 34, 36, 38), in that, a second channel (34) being configured to receive wires which run through the length of said additional channels and said overtube (100) in order to ensures that said overtube (100) does not become floppy. The device (100) as claimed in claim 1 wherein, said plurality of channels being at least four circumferentially located additional channels (32, 34, 36, 38), in that, a third channel (36) being configured to receive a flap thread, such that a thread runs through said third channel (36) and ends at said first opening (14a) where a flap is located, said flap being tied to said thread and said flap configured to be moved based on said thread’s pull, said flap being coupled to an inside wall of said overtube. The device (100) as claimed in claim 1 wherein, said plurality of channels being at least four circumferentially located additional channels (32, 34, 36, 38), in that, a fourth channel (38) being configured to receive a first balloon (20) being configured to inflate, through said first opening (14a), said first balloon (20) being coupled to an outside wall of said overtube (100). The device (100) as claimed in claim 1 wherein, said device comprising a second balloon (30) within said channel (12), at a distal end of said channel (12), at a first opening (14a) and beyond said second opening (14b), said second balloon (30) acting as a second, alternative, mechanism to ensure that said endoscope is blocked from going straight through said distal first opening (14a) by inflating said second balloon (30) into the lumen of said channel (12) distal to said second opening (14b), said second balloon (30) being coupled to an inside wall of said overtube (100). The device (100) as claimed in claim 1 wherein, an operative distal end of said first outer channel (12) having two openings; one opening at an operative distal end and another opening at a location just proximal to said balloon. The device (100) as claimed in claim 1 wherein, said overtube (100) comprising a plurality of additional channels (32, 34, 36, 38), in that,

- each of said additional channels (32, 34, 36, 38) being, circumferentially, dispersed about said second outer channel (14);

- each of said additional channels (32, 34, 36, 38) having a proximal entry port; and

- each of said additional channels (32, 34, 36, 38) running through a length of said overtube device (100).

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