# Patent

## Title
Overtube with expandable tip

## Abstract

An endoscopic overtube with articulating fingers extending from the distal end. The articulating fingers form an opening that may be expanded by a balloon. When positioned in a puncture site in a tissue wall, the articulating fingers dilate and enlarge the puncture site to allow for the body of the overtube to pass through the puncture site. In various embodiments, the fingers may further comprise cutting elements to assist in the dilation of the puncture site.

## Background
BACKGROUND
Endoscopy refers to looking inside the human body for medical reasons. Endoscopy may be performed using an instrument called an endoscope. Endoscopy is a minimally invasive diagnostic medical procedure used to evaluate the interior surfaces of an organ by inserting a small tube into the body, often, but not necessarily, through a natural body opening or through a relatively small incision. Through the endoscope, an operator may observe surface conditions of the organs, including abnormal or diseased tissue such as lesions and other surface conditions. The endoscope may have a rigid or a flexible tube and, in addition to providing an image for visual inspection and photography, the endoscope may be adapted and configured for taking biopsies, retrieving foreign objects, and introducing medical instruments to a tissue treatment region referred to as the work site. Endoscopy is a vehicle for minimally invasive surgery.
Laparoscopic surgery is a minimally invasive surgical technique in which operations are performed through small incisions (usually 0.5-1.5 cm), keyholes, as compared to larger incisions needed in traditional open-type surgical procedures. Laparoscopic surgery includes operations within the abdominal or pelvic cavities, whereas keyhole surgery performed on the thoracic or chest cavity is called thoracoscopic surgery. Laparoscopic and thoracoscopic surgery belong to the broader field of endoscopy.
A key element in laparoscopic surgery is the use of a laparoscope: a telescopic rod lens system that is usually connected to a video camera (single-chip or three-chip). Also attached is a fiber-optic cable system connected to a “cold” light source (halogen or xenon) to illuminate the operative field, inserted through a 5 mm or 10 mm cannula to view the operative field. The abdomen is usually insufflated with carbon dioxide gas to create a working and viewing space. The abdomen is essentially blown up like a balloon (insufflated), elevating the abdominal wall above the internal organs like a dome. Carbon dioxide gas is used because it is common to the human body and can be removed by the respiratory system if it is absorbed through tissue.
Minimally invasive therapeutic procedures to treat diseased tissue by introducing medical instruments to a tissue treatment region through a natural opening of the patient are known as Natural Orifice Translumenal Endoscopic Surgery (NOTES)TM. In general, there are a variety of systems for inserting an endoscope through a natural opening in the human body, dissecting a lumen, and then, treating the inside of the abdominal cavity. For example, in U.S. Pat. No. 5,297,536, which is incorporated by reference herein, a sample treatment system is disclosed. This system is comprised of a dissecting device for perforating a lumen wall; an endoscope insert member for inserting an endoscope, a tube, an endoscope, and a pneumoperitoneum device for deflating the abdominal cavity; and a closing device.
When transluminal endoscopic surgery is carried out using this system, an endoscope insert member and overtube are first inserted through a natural opening in the human body (mouth, anus, or vagina, for example). The overtube may be absorbed to a required organ wall by vacuum pressure, thus being fixed thereon. An incising instrument may be passed through the overtube, or through the working channel of the endoscope, to form a perforation through the surface of the organ wall. An inflation device, such as a balloon, may be placed in the incision and inflated to radially expand the incision. Once the incision has been enlarged, the overtube then may be inserted through the organ wall to serve as a working channel for the endoscope and other tools. After surgery of the inside of the abdominal cavity is complete, the overtube may be removed from the enlarged incision, the perforation in the organ wall may be closed by an O-ring, and the endoscope and overtube may be withdrawn from the body.
In various known techniques, difficulties may arise when inserting the overtube through the organ wall or other tissue. For example, the organ wall may catch or snag at the interface between the distal end of the tube and the inflation device. Such interference with the organ wall may impede the smooth entry of the overtube through the organ wall. Accordingly, in the field of endoscopy, there remains a need for improved methods and devices for inserting an overtube through a tissue wall during an endoscopic surgical procedure.



FIGURES
The novel features of the various embodiments are set forth with particularity in the appended claims. The various embodiments, however, both as to organization and methods of operation may best be understood by reference to the following description, taken in conjunction with the accompanying drawings as follows.
FIG. 1 illustrates one embodiment of endoscopic system and an overtube.
FIG. 2A illustrates one embodiment of the distal tip of the overtube shown in FIG. 1.
FIG. 2B illustrates a cross-sectional view of the distal tip of the overtube shown in FIG. 2A.
FIG. 2C illustrates one embodiment of the distal tip of the overtube shown in FIG. 1.
FIG. 3 illustrates one embodiment of the distal tip of an overtube.
FIG. 4 illustrates one embodiment of the distal tip of an overtube.
FIGS. 5A-5C show the progression of one embodiment of an overtube during a transluminal procedure using the stomach cavity.
FIGS. 6A-6F show the progression of one embodiment of an overtube penetrating through a tissue wall during a transluminal procedure.



DESCRIPTION
It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician or user manipulating one end of an instrument that protrudes out of a natural orifice (or opening) of the patient. The term “proximal” refers to the portion of the instrument closest to the clinician and the term “distal” refers to the portion located furthest from the clinician. It will be further appreciated that for conciseness and clarity, spatial terms such as “vertical,” “horizontal,” “up,” and “down” may be used herein with respect to the drawings. However, surgical instruments may be used in many orientations and positions, and these terms are not intended to be limiting and absolute.
During the course of various surgical procedures, especially in intraluminal and transluminal procedures, there often exists a need to create a surgical space for advancing overtubes and surgical instruments or for allowing a surgeon to access a surgical site or work site, for example. Expandable balloons may be used to create a surgical space in advance of the surgical instrument. For example, a small needle (such as a Veress needle) or guidewire that can be first introduced through an organ wall, for example. A deflated balloon can then be introduced into the hole or incision created by the advancing needle or guidewire. As the balloon is transitioned from a deflated or collapsed position to an inflated or expanded position, the balloon can displace the adjacent tissue, creating a surgical space capable of receiving the advancing overtube and/or other surgical instruments.
FIG. 1 illustrates one embodiment of an overtube 10. The overtube 10 is generally flexible so as to allow navigation through the tortuous pathway of a body lumen during an endoscopic procedure. The size of the overtube 10 can vary, but in various embodiments it has a length that allows it to be inserted translumenally, such as through a patient's esophagus, and the diameter of its inner lumen allows an endoscope to be received therein. The overtube 10 can be made flexible using various techniques. For example, the overtube 10 can be formed from a flexible material, and/or it can include one or more features formed therein to facilitate flexibility, such as a plurality of cut-outs or slots. In other embodiments, the overtube 10 can be formed from a plurality of linkages that are movably coupled to one another. The overtube 10 can also include regions that vary in flexibility. For example, certain portions of the overtube 10, such as the distal portion, can be more rigid than other portions of the overtube 10, such as the proximal portion, to correspond to the shape of a body lumen through which the overtube 10 is being inserted. This can be achieved by forming the overtube 10 from different materials, varying the diameter or thickness of the overtube 10, or using various other techniques know in the art. A person skilled in the art will appreciate that the overtube 10 can have virtually any configuration that allows the overtube 10 to flex as it is inserted through a tortuous body lumen. The overtube 10 can also include other features to facilitate use, such as one or more spiral wires embedded therein and configuration to preventing kinking of the overtube 10 during flexure.
Still referring to FIG. 1, an endoscopic system 12 may be used with the overtube 10. The endoscopic system 12 may be comprised of a control unit 14 and an insertion portion 16. As illustrated, the insertion portion 16 may be inserted into the proximal end 18 of the overtube 10. The insertion portion 16 may be inserted through an inner lumen 13 (FIG. 2A) extending the length of the overtube 10. The distal end of the insertion portion 16 may extend distally from a distal end 20 of the overtube 10. It is appreciated that other tools and instruments may be inserted into the proximal end 18 of the overtube 10 and extend distally from the proximal end 18 of the overtube 10. Additionally, as may be readily understood by those skilled in the art, various tools and instruments may be inserted through various working channels or lumens internal to the insertion portion 16 of the endoscopic system 12.
The control unit 14 of the endoscopic system 12 may comprise a control knob 22 for manipulating or bending the insertion portion 16. An air/water feed button 24 and a suction button 26 may be arranged on the side of the control unit 14. A cord 28 may be coupled to the control unit 14. As appreciated by those skilled in the art, various embodiments of the control unit 14 may have different configurations with different functionality. Furthermore, as may be readily appreciated, the control unit 14 may be configured for manual control by a clinician (as shown in FIG. 1) or configured for other types of control, such as electronic or motorized, for example.
In one embodiment, the overtube 10 may be employed in conjunction with a flexible endoscope, such as the GIF-100 model available from Olympus Corporation. The flexible endoscope may be introduced into the patient trans-anally through the colon, orally through the esophagus, vaginally through the uterus, or the abdomen via an incision or keyhole and an overtube, for example. The endoscope assists the surgeon to guide and position surgical devices near the tissue treatment region or target site to treat diseased or damaged tissue in various body lumens and organs such as the abdomen, esophagus, stomach, colon, liver, breast, brain, lung, and other internal tissue treatment regions.
An embodiment of the distal end 20 of the overtube 10 is illustrated in FIG. 2A. As shown, the overtube 10 may comprise a body 11 and fingers 28 extending distally from the distal end 20. The fingers 28 may have a thickness determined by a sidewall 34. The sidewall 34 may have uniform thickness (as shown), or, in various embodiments, the thickness of the sidewall 34 may vary. For example, the thickness of the sidewall 34 may decrease toward the distal ends of the fingers 28. The thickness of the sidewall 34 may be substantially similar to sidewall thickness of the body 11, or, in various embodiments the relative thicknesses may differ. The fingers 28 are configured to create a radially expandable tip located on the distal end 20 of the overtube 10. The fingers 28 may slope inwardly toward the longitudinal axis (shown as “L”) of the overtube 10 to create a generally tapered distal end. An opening 30 is thereby created by the distal ends of the fingers 28. Each finger 28 may be configured to radially articulate with respect to the longitudinal axis L thereby varying the diameter of the opening 30. In various embodiments the fingers 28 may be each separated by a notch 32. The notches 32 may separate adjacent fingers 28 and may be of any suitable shape, such as substantially a teardrop shape. Similarly, the fingers 28 may be constructed in any suitable shape. For example, ends 29 of the fingers 28 may be generally rounded (as shown in FIG. 2A), or the ends 29 may have other configurations, such as pointed or flat, for example. Furthermore, the fingers 28 may be, for example, transparent, opaque, or a combination of both. The fingers 28 may be biased to a “closed”, or first position, shown in FIG. 2A.
FIG. 2B shows a cross-sectional view of the embodiment of the overtube 10 shown in FIG. 2A. As illustrated, in various embodiments, the profile of fingers 28 may have a curvature defined by a radius “r,” which converges on a point 35. In other embodiments, the fingers 28 may have different profiles, including profiles which comprise both flat and curved sections. It may also be appreciated that each finger 28 may have a different profile than other fingers 28.
Referring now to FIG. 2C, an embodiment of the overtube 10 in an “open”, or second position is illustrated. As shown, the fingers 28 are radially articulated or expanded, thereby increasing the opening 30 at the distal end 20 of the overtube 10. In various embodiments, the opening 30 may increase to a diameter up to the diameter of the body 11. As shown in FIG. 2C, as the fingers 28 articulate the notches 32 also change shape and expand to accommodate the articulation of the fingers 28 from the closed position to the open position.
In various embodiments the overtube 10 may have any suitable number of fingers or tabs extending from the distal end 20. As shown in FIG. 3, the illustrated embodiment comprises four fingers 28 extending from the distal end 20. In some implementations, the distal end 20 may comprise additional or fewer fingers. In various embodiments, the fingers 28 each may have different dimensions or may be formed in a different shape. In some implementations, a first plurality of fingers 28 may be comprised of a first shape and a second plurality of fingers 28 may be comprised of a second shape. While certain embodiments of the fingers 28 have been disclosed, the configurations of the fingers 28 are not limited to these embodiments. As understood by those skilled in the art, any suitable finger configuration may be used.
As illustrated in FIG. 4, the distal end 20 of the overtube 10 may comprise cutting elements 36 extending from an outer surface of the fingers 28. In some embodiments, the cutting elements 36 may extend substantially perpendicularly from the fingers 28. Each finger 28 may include a cutting element 36, or, in various embodiments, only certain fingers may include a cutting element 36. In other embodiments, the fingers 28 each may include multiple cutting elements 36. The cutting element 36 may include a cutting edge 38. The cutting edge 38 may be sharpened, or otherwise configured to aid in the cutting of tissue during use of the overtube 10. The cutting elements 36 may be formed unitary with the associated fingers 28. Or, in various embodiments, the cutting elements 36 may be fastened to or coupled to the associated fingers 28. The cutting elements 36 may be an integrally formed recess on the exterior surface of the fingers 28. The cutting elements 36 may be configured in any suitable shape. As illustrated, the cutting elements 36 may extend to the distal ends 29 of the fingers 28. In various embodiments, the cutting elements 36 may be coupled to an energy source to aid in the cutting of tissue.
Still referring to FIG. 4, the overtube 10 may include a gripping section 40. The gripping section 40 is configured to assist in keeping the overtube 10 in various orientations during surgical procedures. For example, the gripping section 40 may increase the coefficient of friction between the overtube 10 and the tissue through which the overtube 10 is positioned. The gripping section 40 may be, for example, a series of ribs or otherwise textured surface. In the illustrated embodiment, the gripping section 40 is shown as a band located near the distal end 20 of the overtube 10, however any suitable size and configuration may be used.
FIGS. 5A-5C illustrate an example use of the overtube 10 during a surgical procedure. Referring first to FIG. 5A, the overtube 10 may be introduced into the stomach cavity 42 through the mouth (not shown) and esophagus 44. It is appreciated that the use of the overtube 10 is not limited to use with the stomach cavity 42. It may be used within any body cavity, such as the uterus, colon, for example. Referring next to FIG. 5B, and as described in more detail below, the overtube 10 may penetrate the stomach wall 43. Once the distal end 20 of overtube 10 has penetrated the stomach wall 43, working tools, such as an endoscope 46 may be inserted into the proximal end 48 of the overtube 10 and fed through the body 11 and ultimately extend from the distal end 20 of the overtube 10 (FIG. 5C). Once in place, the overtube 10 serves as a conduit for a user to feed various tools and components to a working site.
An example penetration of an embodiment of the overtube 10 through tissue is shown in FIGS. 6A-6F. Referring first to FIG. 6A, the overtube 10 is shown positioned within a first body cavity 60. The first body cavity 60 may be, for example, the stomach, colon, or uterus. A second body cavity 62 is illustrated which is separated from the first body cavity 60 by tissue 64. The tissue 64 may be, for example, the stomach wall, colon wall, uterus wall, or other organ or tissue. In order to access the second body cavity 62 with tools, such as an endoscope or graspers, the tissue 64 must be penetrated. In various embodiments, a tool, such as the endoscope 46 is fed down the body 11 of the overtube 10. A needle 66, or other incising device, such as a tubular stylette or guidewire, may be fed through a working channel of the endoscope 46 to make a puncture site 68 in the tissue wall 64. Referring now to FIG. 6B, the distal ends of the fingers 28 may be inserted into the puncture site 68 by the user through longitudinal movement of the overtube 10 in the direction indicated by arrow 70. As illustrated, the distal end 20 is in the “closed”, or first position. A deflated balloon 72 associated with the needle 66 also may be advanced into the puncture site 68 such that the fingers 28 are positioned in between the deflated balloon 72 and the tissue wall 64. As illustrated in FIG. 6B, the needle 66 and a portion of the deflated balloon 72 may extend distally from the opening 30 of the overtube 10. In various embodiments, approximately half of the deflated balloon 72 may be positioned in the second cavity 62 through the puncture site 68, with a portion of a proximal portion of the deflated balloon 72 remaining internal to the radially expandable tip of the overtube 10.
Once the distal ends of the fingers 28 have been inserted into the puncture site 68, the puncture site 68 then may be expanded to accommodate the body 11 of the overtube 10. The balloon 72 may be used to expand the puncture site 68. The inflation of the balloon 72 may be controlled via the control unit 14 operated by the user.
FIG. 6C illustrates one embodiment of the overtube 10 and the balloon 72 when the balloon 72 is partially inflated with a fluid, such as saline or carbon dioxide, for example. As illustrated, the inflation of balloon 72 forces the fingers 28 to articulate or expand radially with respect to the longitudinal axis L. As the fingers 28 articulate radially, the circumferential tissue at the puncture site 68 is enlarged or dilated. In various embodiments, cutting elements 32 (FIG. 3) may be used to assist in the dilation.
FIG. 6D illustrates one embodiment of the overtube 10 and the balloon 72 when the balloon 72 is nearly fully inflated with the fluid. As illustrated, the further inflation of balloon 72 by the user forces the fingers 28 to articulate radially with respect to the longitudinal axis L. As the fingers 28 articulate radially, the opening 30 at the distal end 20 of the overtube 10 continues to enlarge or dilate.
FIG. 6E illustrates one embodiment of the overtube 10 and the balloon 72 when the balloon 72 is inflated with the fluid to nearly fully articulate or expand the fingers 28. As illustrated, once the fingers are nearly fully articulated, the puncture site 68 in the tissue wall 64 is nearly the same diameter as the body 11. Once the puncture site 68 is expanded by the articulating fingers 28, the overtube 10 may be advanced in the direction indicated by arrow 70 to pass into the second body cavity 62.
FIG. 6F illustrates one embodiment of the overtube 10 accessing the second body cavity 62. As illustrated, the balloon 72 has been deflated and retracted from the distal end 20 of the overtube 10. The endoscope 46 has been advanced in the direction indicated by arrow 70 to extend distally from the distal end 20 of the overtube 10. As shown in FIG. 6F, the fingers 28 may articulate radially to accommodate the endoscope 46 as it advances distally. Once the second body cavity 62 has been accessed, tools, such as graspers 78 may be deployed by the user to perform the required tasks in the second body cavity 62.
The devices disclosed herein can be designed to be disposed of after a single use, or they can be designed to be used multiple times. In either case, however, the device can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the device, followed by the cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the device can be disassembled, and any number of the particular pieces or parts of the device can be selectively replaced or removed in any combination. Upon the cleaning and/or replacement of particular parts, the device can be reassembled for subsequent use either at a reconditioning facility or by a surgical team immediately prior to a surgical procedure. Those skilled in the art will appreciate that the reconditioning of a device can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques, and the resulting reconditioned device, are all within the scope of the present application.
Preferably, the various embodiments described herein will be processed before surgery. First, a new or used device is obtained and, if necessary, cleaned. The instrument can then be sterilized. In one sterilization technique, the device is placed in a closed and sealed container, such as a plastic or TYVEK® bag. The container and device are then placed in a field of radiation that can penetrate the container, such as gamma radiation, x-rays, or high-energy electrons. The radiation kills bacteria on the instrument and in the container. The sterilized device can then be stored in the sterile container. The sealed container keeps the instrument sterile until it is opened in the medical facility. It is preferred that the device is sterilized. This can be done by any number of ways known to those skilled in the art, including beta or gamma radiation, ethylene oxide, or steam.
Although the various embodiments have been described herein in connection with certain disclosed embodiments, many modifications and variations to those embodiments may be implemented. Also, where materials are disclosed for certain components, other materials may be used. The foregoing description and following claims are intended to cover all such modifications and variations.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated material does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.

## Claims

1. A translumenal overtube device, comprising:
an elongate flexible overtube comprising a distal end, a proximal end, and a body, wherein the body defines a lumen extending the length of the overtube, and wherein the lumen is dimensioned to receive an insertion portion of an endoscope; and
a plurality of radially articulating fingers separated by notches projecting from the distal end of the flexible overtube, wherein at least one of the radially articulating fingers comprises an integrally formed cutting element recessed on an exterior surface of the at least one of the radially articulating fingers.

2. The device of claim 1, wherein the radial articulation of the fingers is configured to dilate a tissue opening.

3. The device of claim 2, wherein each finger has a distal end and a proximal end, the distal end forming an expandable opening.

4. The device of claim 3, wherein the expandable opening expands when the plurality of fingers radially articulate.

5. The device of claim 4, wherein the expandable opening is configured to receive a tool therethrough.

6. The device of claim 4, wherein the expandable opening is configured to receive an incising device therethrough.

7. The device of claim 1, wherein the overtube comprises at least a first finger, a second finger, and a third finger.

8. The device of claim 1, wherein the distal end of the overtube has a non-articulated position and an articulated position, wherein the distal end of the overtube is tapered in the non-articulated position.

9. The device of claim 8, wherein a balloon is used to move the distal end from the non-articulated position to the articulated position.

10. The device of claim 1, wherein the cutting element comprises a cutting edge.

11. The device of claim 1, wherein an exterior surface of the overtube comprises a gripping portion configured to assist in keeping the overtube in an orientation during a surgical procedure.

12. The device of claim 11, wherein the gripping portion includes a surface having a higher coefficient of friction than remaining portions of the overtube.

13. The device of claim 12, wherein the surface having a higher coefficient of friction comprises a series of ribs.

14. The device of claim 12, wherein the surface having a higher coefficient of friction comprises a textured surface.

15. A translumenal overtube device, comprising:
an elongate flexible overtube comprising a distal end, a proximal end, and a body, wherein the body defines a lumen extending the length of the overtube, and wherein the lumen is dimensioned to receive an insertion portion of an endoscope; and
a plurality of radially articulating fingers separated by notches projecting from the distal end of the flexible overtube, wherein at least one of the plurality of radially articulating fingers comprises an integrally formed cutting element recessed on an exterior surface of the at least one of the radially articulating fingers, wherein the distal end of the overtube has a non-articulated position and an articulated position, wherein the distal end of the overtube is tapered in the non-articulated position, and wherein a balloon is used to move the distal end from the non-articulated position to the articulated position.

16. A translumenal overtube device, comprising:
an elongate flexible overtube comprising a distal end, a proximal end, and a body, wherein the body defines a lumen extending the length of the overtube, and wherein the lumen is dimensioned to receive an insertion portion of an endoscope, wherein an exterior surface of the overtube comprises a gripping portion configured to assist in keeping the overtube in an orientation during a surgical procedure; and
a plurality of radially articulating fingers separated by notches projecting from the distal end of the flexible overtube, wherein at least one of the plurality of radially articulating fingers comprises an integrally formed cutting element recessed on an exterior surface of the at least one of the radially articulating fingers.

17. A translumenal overtube device, comprising:
an elongate flexible overtube comprising a distal end, a proximal end, and a body, wherein the body defines a lumen extending the length of the overtube, wherein an exterior surface of the overtube comprises a gripping portion configured to assist in keeping the overtube in an orientation during a surgical procedure, wherein the lumen is dimensioned to receive an insertion portion of an endoscope; and
a plurality of radially articulating fingers separated by notches projecting from the distal end of the flexible overtube, wherein the distal end of the overtube has a non-articulated position and an articulated position, wherein the distal end of the overtube is tapered in the non-articulated position, and wherein a balloon is used to move the distal end from the non-articulated position to the articulated position, wherein at least one of the plurality of radially articulating fingers comprises an integrally formed cutting element recessed on an exterior surface of the at least one of the radially articulating fingers.