An overtube device for use in intubation during an endoscopic procedure is disclosed. The device includes an outer tube and an inner tube. The outer tube includes a distal end, a proximal end, and a first handle disposed on the proximal end. The inner tube includes a distal end, a proximal end, and a second handle disposed on the proximal end. The inner tube is inserted through an entire length of the outer tube such that the inner tube extends beyond the outer tube. At the proximal end of the device, a proximal end of the first handle is connected to a distal end of the second handle. When the inner tube is co-axially inserted within the outer tube, a clearance exists between a length of the inner and outer tubes, and between a length of the inner tube and the endoscope. Methods of use are disclosed.

FIELD OF THE INVENTION

The present invention relates to an overtube assembly and more particularly to an overtube assembly for use in intubating a human subject as part of an endoscopic procedure.

BACKGROUND OF THE INVENTION

Endoscopes are well-known in the art and are commonly used for numerous medical procedures that involve intubation of the esophagus and gastro-intestinal tract. As such, many devices and accessory instruments have been developed that relate to the operation of an endoscope. Devices that aid a physician in intubation, such as an overtube, are one such type of device in the endoscopic art field.

In general, an overtube may be used by a physician during an endoscopic procedure. An endoscope is inserted within an overtube, and then the assembly is inserted into a patient's esophagus. The overtube remains in place within a patient's esophagus, while the endoscope may be inserted and removed many times, during a so-called multiple intubation procedure. This technique is designed to reduce damage to the esophagus otherwise caused by repeated insertions. However, physicians have expressed their concerns regarding the design of conventional overtubes. Specifically, the complaints center on a small annular gap existing between the distal end of the overtube and the endoscope. Mucosal tissue may become pinched or trapped in this gap during initial insertion, causing severe damage to the esophagus. Tearing of the submucosal and/or muscularis layer is also possible. As such, clinical use of overtubes in general has reduced significantly. Therefore, a need exists in the art for an overtube assembly design that does not cause mucosal tissue damage.

The present invention is an improved intubation assembly that includes an inner tube and an outer tube. The overtube assembly provides a device for aiding intubation that reduces damage to the mucosal tissue, maintains a proximal end seal to maintain consistent insufflation and minimize leakage of bodily fluids during procedure, offers a convenient intubation method, and reduces the overall time of the endoscopic procedure. Other benefits of the present invention include an expandable distal end of the outer tube to accommodate oversized foreign objects and distance markings on the outer tube.

SUMMARY OF THE INVENTION

In an embodiment of the present invention, an overtube assembly for use in intubating a human subject as part of an endoscopic procedure is disclosed. Use of the device avoids pinching of the esophagus mucosa layer during intubation. Method of use are also disclosed. It should be apparent to others with ordinary skill in the art that use of this assembly is not limited to the esophagus intubations, but may also include gastric, small bowel, and colonic intubations and trans-oral, trans-gastric surgeries.

The overtube includes a outer tube, an inner tube, and a seal cap. The outer tube includes an elongated tube having a distal end, a proximal end, and a first handle disposed on the proximal end. The inner tube includes an elongated tube having a distal end, a proximal end, and a second handle disposed on the proximal end. The inner tube is inserted through an entire length of the outer tube such that inner tube distal end extends beyond the outer tube distal end. A proximal end of the first handle is connected to a distal end of the second handle. With the second handle removed, the seal cap is adapted to form a seal with the proximal end of the first handle.

Further features and advantages of the invention will become apparent from the following detailed description made with reference to the accompanying drawings.

The Detailed Description of the Invention merely describes preferred embodiments of the invention and is not intended to limit the scope of the claims in any way. Indeed, the invention as described by the claims is broader than and unlimited by the preferred embodiments, and the terms in the claims have their full ordinary meaning.

DESCRIPTION OF THE INVENTION

An overtube device for use in intubating a human subject as part of an endoscopic procedure is disclosed. Hereinafter, the terms “inner tube” and “outer tube” are used to describe two separate items, and the term “overtube device” is used to describe an assembly unless otherwise noted. Further, it should be understood by one with ordinary skill in the art that the relative size of the assembly shown is for exemplary purposes only, and the present invention is applicable with a wide range of endoscope sizes.

In discussing the assembly, the terms distal and proximal are used with respect to the perspective of the operator. In other words, when the device is used in connection with an endoscope or other medical device, the proximal and distal orientation are relative to the surgeon or operator of the device.

Referring now to the Figures, a perspective assembly view of an overtube device constructed in accordance with an embodiment of the present invention is shown inFIG. 1. Specifically, an inner tube10, an outer tube12and a tethered cap50are illustrated in a separated position. The tubes form an overtube device for use in intubating a human subject as part of a procedure using an endoscope.FIG. 2ais an enlarged cross-sectional view of the device ofFIG. 1, showing the inner tube10and outer tube12in an assembled position.

The outer tube12includes an elongated tube14, a tapered portion16disposed on the tube14distal end, and a first handle18disposed on the tube14proximal end. The elongated tube14may include length identifying indicia22. As shown, the indicia22are a series of equally spaced length markings on the outer tube. These markings allow a physician to monitor depth during initial insertion of the elongated tube14, as well as to monitor any migration of the assembly during multiple intubations. The outer tube shown is a 50 cm tube but it should be clear to others skilled in the art that the present invention is not limited to any particular tube length. The elongated tube14may also include circumferentially spaced coils in a portion of the tube. The coils add strength to the tube during insertion.

The first handle18has a base18b,a proximal end19aand a distal end19b.The base18bis constructed of a hard plastic and may be covered with a foam material20for helping an operator grip the handle. As seen inFIGS. 1 and 2a,the proximal end of the first handle18is a threaded opening23.

The inner tube10includes an elongated tube24, a tapered cuff26disposed on the distal end of the elongated tube24, and a second handle28. The elongated tube24may be constructed of any suitable polymer, such as for example, extruded polyvinyl chloride. As illustrated, the elongated tube24is illustrated without internal coils or springs of any kind. The lack of coils reduces costs and increases the clearance room for the endoscope, although coils could be used in the practice of the present invention to add strength to the inner tube. The inner tube shown is clear, however it may be frosted. Such a treatment reduces the friction between the inner tube and the outer tube, as well as between the inner tube and the endoscope.

Referring now toFIG. 2b,an enlarged cross-sectional view of the assembly ofFIG. 2ais shown with an endoscope30inserted co-axially through the inner tube24. The elongated tube24has an inner diameter D1greater than an outer diameter D2of the illustrated conventional endoscope. As a result, a clearance exists between the inner tube24and the endoscope30along nearly the entire length of the inner tube. This clearance reduces friction during insertion of the endoscope30within the inner tube24.

The size relationship between the outer tube and the inner tube is also designed to reduce friction. The outer diameter of the inner tube is less than the inner diameter of the outer tube. Consequently, when the inner tube is co-axially inserted within the outer tube as shown inFIG. 2a,a clearance exists between the inner tube and the outer tube along a length of the inner tube. This clearance facilitates the initial insertion by the physician of the inner tube10within the outer tube12.

As mentioned, the inner tube10shown inFIG. 1includes a cuff. The tapered cuff26is fixed onto the distal end of the elongated tube24by bonding or some other suitable known method. As shown inFIGS. 1 and 2a,the cuff26overlaps the elongated tube24by a length L1. The cuff26has a tapered portion32that defines an inner cuff diameter D3. This inner diameter is sized such that the cuff26forms a seal around the outer surface of the endoscope30inserted therethrough. The tapered cuff26may be constructed from various methods, such as for example, from a dip molded process or injection molding. Further, the elongated tube24and cuff26may be constructed as an integral piece.

FIG. 3is a schematic view showing a human patient intubated with the assembly shown inFIG. 2b.When the distal end11of the inner tube10is inserted beyond the distal end13of the outer tube12, the inner tube distal end and the outer tube distal end form a seal. In the assembled position shown inFIG. 2aand2b,a distal end of the outer tube and a distal end of the inner tube are sealed, preventing any damage or pinching of the esophagus tissue during insertion.FIG. 2cis an enlarged cross-sectional view of the bottom portion ofFIG. 2b.The position of the outer tube14, inner tube24and endoscope30in relation to tissue layers of the esophagus205are shown. The layers, i.e., the mucosa27a,the submucosa27b,and the muscularis27care illustrated on either side of the device. No pinching or tearing of tissue has occurred.

Referring now toFIG. 2d,a cross-sectional view of a prior art device is shown. Specifically, the position of a prior art overtube27dand an endoscope30are illustrated in relation to tissue layers27a,27b,27cof the esophagus. In this design, the layers are allowed to curl back toward the mouth in an area between the endoscope30and the overtube27d.Tissue in this area is prone to pinching. A typical result is illustrated inFIG. 2e,which is a cross-sectional view of the designated circle area ofFIG. 2d.A “V-shaped” tear27eextending through the mucosa27aand into the submucosa27blayer is shown. Other shear, tear and pinch patterns are known in the prior art, such as for example, a complete tearing through all three layers.

As mentioned and again referring toFIG. 2a,the inner tube10includes a second handle28at a distal end of the elongated tube24. The second handle28has a base28b,a proximal end29aand a distal end29b.The base28bis constructed of a hard plastic and may be covered with a foam grip material40for helping an operator grip the handle28, such as for example, when connecting the second handle28to the first handle18.

As seen inFIG. 1, the distal end of the first handle18includes an externally threaded portion42. When the distal end11of the inner tube10is inserted beyond the distal end13of the outer tube12, the threaded portion23in the first handle18proximal end19acan be easily connected to the threaded portion42in the second handle28distal end29b.As such, the first handle18is distal to the second handle28.

Still referring toFIG. 2a,a seal cap50is shown connected to the outer tube12by a tether52. The cap50is connected at a location adjacent the first handle18distal end19b.A plastic ring54is disposed at either end of the tether52. The tether52retains the cap50within proximity of the handle18when not in a sealed position.

The cap50has a base50b,a proximal end55aand a distal end55b.The base50bis constructed of a hard plastic and may be covered with a foam material56for ease of use. As seen inFIG. 2a,the base50bincludes a protruding portion58that can be inserted directly into the outer tube12proximal end19aof the first handle18. The proximal end of the protrusion58includes an externally threaded portion60for connection to the threaded portion23in the first handle18proximal end19a,as shown inFIG. 4a.

The seal cap as shown includes a flexible seal62having a center aperture64. The seal62aperture64is sized to form a seal around the outer surface of an endoscope inserted therethrough. A seal cap50installed onto an outer tube12is shown inFIG. 5awith the inner tube10removed. As shown, a seal is formed between the seal60and the endoscope30. In this position, the endoscope30is free to laterally move within a length of the outer tube. A seal is maintained around the endoscope outer surface during lateral movement of the endoscope in either direction. Consequently, no venting occurs between the endoscope and the seal.FIG. 5bshows schematic view of a human patient intubated with the assembly shown inFIG. 5a.

The cap50may include more than one seal or include a seal having more than one aperture.FIG. 12is a perspective assembly view of alternative cap65of the present invention. The cap65includes a seal66having two apertures, a first aperture64for insertion of an endoscope30and a second aperture68for insertion of a second endoscopic instrument70, such as for example, a snare, a net, or a suction device. As shown, a seal is formed between the seal66and the endoscope30and between the seal66and the instrument70.

FIG. 6is a cross-sectional view of another embodiment of the present invention. As shown, an endoscope30is inserted through an outer tube114. A cuff126having a tapered portion132is glued onto the distal end of the outer tube114. The tapered cuff126forms a seal around the outer surface of an endoscope30inserted therethrough as shown. A handle130is fixed to the proximal end of the outer tube114. The device includes a cap132connected to the outer tube114by a tether134. The cap132is removably connectable to the proximal end of the handle130. The cap has an aperture136adapted to form a seal around the outer surface of the endoscope30inserted therethrough as shown.

FIG. 7ais a cross-sectional view of yet another embodiment of the present invention. An elongated inner tube24is shown inserted into an elongated outer tube14with an endoscope30inserted through the inner tube. At the distal end of the outer tube14, a protective hood140is shown in an inverted position fixed to the outer tube. In the practice of the present invention, the hood is used in the capture of foreign objects in the gastro-intestinal tract. Specifically, the hood protects the esophagus, trachea and throat when the object is being remove. Therefore, the hood140may be constructed of any suitable tear resistant polymer of sufficient strength. A non-latex material is preferred to prevent irritation or reaction caused by allergies.

Another embodiment of the present invention that includes a hood is shown inFIG. 7b.An endoscope30is shown inserted through an outer tube114. A protective hood140is fixed to the distal end of the outer tube114. The hood140is illustrated in an inverted position. For exemplary purposes, the removal of a razor blade using the device ofFIG. 7bwill be discussed.

FIG. 8is a cross-sectional view of device ofFIG. 7b,showing the protective hood140in a forward position. At the beginning of the removal process, a physician will insert the distal end of the device into the stomach. A seal is formed between the endoscope30and the tapered cuff132. As a result, no pinching or tearing of the esophagus tissue occurs during initial insertion.

Within the stomach, it is possible to manipulate the hood to the forward position shown inFIG. 8by pulling back on the device. Once the hood is in this forward position, an endoscope30may be extended into the hood. A snare instrument142is shown within an instrument channel of the endoscope30.

The physical capture of the razor blade150is illustrated inFIGS. 9-11. InFIG. 9, the loop144of the snare instrument142is expanded toward the razor blade.FIG. 10shows the razor blade150within the snare loop144. InFIG. 11, the snare loop is shown retracted and collapsed back within the protective hood144. Throughout the entire capture process, a seal is maintained between the endoscope30and the distal end of the outer tube114.

A method of use of an embodiment of the present invention will be discussed. The method is for intubating a human patient as part of an endoscopic procedure. An inner tube10and an outer tube12, as illustrated inFIG. 1, are selected. The inner tube10is inserted through an entire length of the outer tube12such that the inner tube10distal end extends beyond the outer tube12distal end, as shown inFIG. 2a.This insertion step forms a seal between the tubes10,12at the distal end of the assembly.

The next method step is inserting an endoscope30within the inner tube10, as shown inFIG. 2b.After an endoscope is inserted within the inner tube10, a seal is then created at the proximal ends by a connection, e.g., a threaded cap, a snap fit connection, or a bayonet-style connection. Next, the device is delivered to the desired internal location as shown inFIG. 3. In this example, the device is shown inserted through the esophagus205to the stomach200. The method includes preventing any esophagus tissue layers from being pinched between the inner tube and the outer tube distal end during intubation, or between the inner tube tapered distal end and the endoscope. An illustration of desired insertion effect is shown inFIG. 2c.

Next, the proximal connection is released and the inner tube10and endoscope30are removed. The outer tube12stays in place. Any connection structure that allows for the inner tube10to be disengaged from the outer tube12in an efficient, quick and coordinated manner is suitable. Exemplary structure include a snap fit connection and a quarter turn threaded connection.

A cap is subsequently connected to the proximal end of the outer tube12. An exemplary threaded connection between the cap and outer tube12is shown inFIG. 4a.After this connection is made, the device remains in place as shown inFIG. 4b.

The method includes the step of inserting the endoscope30through an aperture in the cap50to form a seal, as shown inFIG. 5a.InFIG. 5b,an endoscope30is shown inserted through an entire length of the outer tube12to beyond the outer tube distal end. In this position, the physician can perform the substantive portion of the endoscopic procedure.

The method may include multiple intubations, i.e., repetitive removal and insertion of the endoscope during the substantive procedure. Repetitive insertions may be required for certain endoscopic procedures. The outer tube12remains in place during the entire procedure to protect the tissue of the esophagus.

While several embodiments of the invention have been illustrated and described, the present invention is not to be considered limited to the precise constructions disclosed. Various adaptations, modifications and uses of the invention may occur to those skilled in the arts to which the invention relates. It is the intention to cover all such adaptations, modifications and uses falling within the scope or spirit of the annexed claims.