# Patent

## Title
Surgical access device

## Abstract

A surgical access device comprises a conduit comprising a proximal portion and a distal portion. An inflatable member at least partially surrounds a portion of the conduit and is positioned proximate to the distal portion of the conduit. In various embodiments, a protective sleeve can at least partially surround a portion of the conduit and is movable between at least a first position and a second position. In at least one embodiment, the protective sleeve is configured to at least partially cover the inflatable member when in the first position and is configured to expose the inflatable member when in the second position.

## Background
BACKGROUND
Endoscopy refers to looking inside a human body for medical reasons using an instrument called an endoscope. Endoscopy is a minimally invasive diagnostic medical procedure used to evaluate interior surfaces of an organ or other tissue by inserting a small tube into the body, often, but not necessarily, through a natural body opening of a patient or through a relatively small incision. Using the endoscope, a surgeon may view surface conditions of the organs or other tissue, including abnormal or diseased tissue such as lesions and other various 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 generally herein as a surgical site.
Laparoscopic surgery is a minimally invasive surgical technique in which operations are performed through small incisions (usually 0.5 cm-1.5 cm) or keyholes, as compared to the larger incisions required 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 and configured to be inserted through a 5 mm or 10 mm cannula to view the surgical site. The abdomen is usually insufflated with carbon dioxide gas to create a working and viewing space for a surgeon. Stated another way, the abdomen is essentially blown up like a balloon (i.e., insufflated) thereby elevating the abdominal wall above the internal organs like a dome. Carbon dioxide gas can be used for the insufflation because it is common to the patient's body and can be removed by the respiratory system if it is absorbed through tissue.
Minimally invasive therapeutic procedures used to treat diseased tissue by introducing medical instruments to the surgical site through a natural opening of a patient are known as Natural Orifice Translumenal Endoscopic Surgery (NOTESTM). 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 to Wilk, issued on Mar. 29, 1994, which is hereby incorporated by reference in its entirety, 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 the above-referenced system or any other suitable system, an overtube can first be inserted through a natural opening in the patient's body (e.g., mouth, anus, or vagina). A distal end of the overtube may be attached to an organ wall or other tissue by vacuum pressure, thus being temporarily fixed thereon such that the organ wall or other tissue can be punctured. An incising instrument, such as a needle, for example, may be passed through the overtube from a proximal end of the overtube to a distal end of the overtube, and/or through a working channel of the endoscope, and used to puncture and create an opening through the organ wall or other tissue. An inflatable member, such as a medical balloon, for example, may be positioned in the opening and then inflated to enlarge the opening. Once the opening has been enlarged by the inflatable member, the inflatable member can be at least partially deflated and removed from the body and/or retracted into the overtube and the overtube may then be inserted into and partially through the opening to serve as a working channel for the endoscope and/or other surgical instruments or devices to the surgical site. After surgery of the inside of the organ or other tissue is complete, the overtube may be removed from the enlarged opening so that the opening can be closed by an O-ring or other suitable closure device and then the endoscope and the overtube may be withdrawn from the body.
In various techniques, difficulties may arise when inserting the inflatable member through the working channel of the endoscope, through the overtube, through the organ wall, and/or through other tissue. In various circumstances, the inflatable member could be breached if it catches or snags a portion of the working channel, such as an end of the working channel, for example, a portion of the overtube, a portion of the organ wall, and/or other tissue. Additionally, the inflatable member can be prematurely inflated in the overtube owing to subatmospheric pressure conditions within the overtube and surrounding the outside walls of the inflatable member. Accordingly, in the field of endoscopy, there remains a need for improved methods and devices for inserting an inflatable member into position in the opening of the organ wall or other tissue 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 figures as follows.
FIG. 1 illustrates a perspective view of a surgical access device comprising an inflatable member covered by a protective sleeve in a first position in accordance with one non-limiting embodiment.
FIG. 2 illustrates a perspective view of the surgical access device of FIG. 1 with the protective sleeve in a retracted or second position to expose the inflatable member in accordance with one non-limiting embodiment.
FIG. 3 illustrates an exploded view of the exposed inflatable member of FIG. 2 in accordance with one non-limiting embodiment.
FIG. 4 illustrates a perspective view of a surgical access device where a protective sleeve is in a retracted or second position and an inflatable member is exposed and inflated through the use of a fluid source in accordance with one non-limiting embodiment.
FIG. 5 illustrates a perspective view of the protective sleeve of the surgical access device of FIG. 1 in accordance with one non-limiting embodiment.
FIG. 6 illustrates a cross-sectional view of the surgical access device taken along line 6-6 of FIG. 1 in accordance with one non-limiting embodiment.
FIG. 7 illustrates a cross-sectional view of a distal portion of the surgical access device of FIG. 1 extending through a working channel of an endoscope and creating an opening in tissue to allow access to a surgical site in accordance with one non-limiting embodiment.
FIG. 8 illustrates a cross-sectional view of the distal portion of the surgical access device of FIG. 7 with the protective sleeve in a first position and being advanced through the opening in the tissue in accordance with one non-limiting embodiment.
FIG. 9 illustrates a cross-sectional view of the distal portion of the surgical access device of FIG. 8 after the protective sleeve has been retracted into the second position to expose the inflatable member to the opening in the tissue in accordance with one non-limiting embodiment.
FIG. 10 illustrates a cross-sectional view of the distal portion of the surgical access device of FIG. 9 after the protective sleeve has been retracted into the second position and with the inflatable member partially inflated to expand the opening in the tissue in accordance with one non-limiting embodiment.
FIG. 11 illustrates a cross-sectional view of the distal portion of the surgical access device of FIG. 9 after the protective sleeve has been retracted into the second position and with the inflatable member sufficiently inflated to expand the opening in the tissue in accordance with one non-limiting embodiment.
FIG. 12 illustrates a surgical access device being used in conjunction with an overtube, an endoscope having various components and inserted into an upper gastrointestinal tract of a patient in accordance with one non-limiting embodiment.
FIG. 13 illustrates a perspective view of a distal portion of a surgical access device extending from a working channel of a distal end of the endoscope of FIG. 12 in accordance with one non-limiting embodiment.



DESCRIPTION
It will be appreciated that the terms “proximal” and “distal” are used herein with reference to a clinician, a surgeon, or a user (“surgeon”) manipulating one end of an instrument or device that protrudes out of a patient (i.e., a natural orifice). The term “proximal” refers to a portion of the instrument or device closest to the surgeon and the term “distal” refers to a portion of the instrument located furthest from the surgeon. 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 figures. Surgical instruments or devices, however, may be used in many orientations and positions and, as such, these terms are not intended to be limiting and absolute.
During the course of various surgical procedures, such as in intraluminal and transluminal procedures, for example, there often exists a need to create a surgical space for advancing overtubes and surgical instruments or devices and/or for allowing a surgeon to access a surgical site. Inflatable members, such as medical balloons, for example, may be used to enlarge an opening or incision (“opening”) in an organ wall or other tissue created by a needle, a needle knife, or other cutting, piercing, incising, or puncturing member (“needle”). In various embodiments, the needle can be hollow such that the most distal ends of the needle can puncture the tissue. In one embodiment, the most distal ends of the needle can comprise cutting, incising, or piercing members. Various inflatable members are commercially available from Boston Scientific Corporation, C. R. Bard, Inc., and Cook Medical Inc., for example. In at least one embodiment, the needle can be a Veress needle or a Rotary needle, for example. Various needles are commercially available from Ethicon Endo-Surgery, Inc. and Covidien Ltd. In other various embodiments, a guidewire with a cutting, piercing, incising, or puncturing member on a distal end thereof can be used, alone or in combination with a needle or hollow needle, to create the opening (hereafter the term “needle” can encompass such guidewire embodiments).
In various embodiments, a hollow conduit can be introduced into a natural opening in a patient's body. In at least one embodiment, the conduit can be inserted into an overtube which has been inserted into the natural opening in the patient's body. In any event, the needle can be introduced into the natural opening of the patient's body through a proximal end of the conduit and can be fed through a distal end of the conduit to access an organ wall or other tissue (“tissue”), for example. In at least one embodiment, an endoscope can be inserted into the overtube through the proximal end of the overtube and extend through or near the distal end of the overtube. In such an embodiment, the conduit can be positioned within a working channel of the endoscope and can extend from a distal end thereof to allow the conduit and the needle to gain access to the tissue proximate to a surgical site or a surgical access site. In various embodiments, the needle and the conduit can be flexible and/or can comprise flexible portions.
In various embodiments, an uninflated inflatable member, such as a medical balloon, for example, can be attached to, sealed to, positioned on, surround, or can be integrally formed with or on at least a portion of an outer surface of a distal portion of the conduit, for example, and can be introduced into the opening in the tissue created by advancing the needle distally through the tissue. The inflatable member can then be transitioned from an uninflated or a collapsed state to an inflated or an expanded state thereby radially or otherwise displacing side walls of the opening to create a larger opening or surgical space in the tissue such that the enlarged opening can receive a portion of the endoscope, a portion of the overtube, and/or portions of other surgical instruments or devices, for example, therethrough. In at least one embodiment, the inflatable member can be at least partially comprised of a flexible material.
In various embodiments, an inflation conduit can surround a portion of the conduit and can extend at least from a fluid source to a proximal portion of the inflatable member such that the inflatable member can be expanded with fluid from the fluid source owing to a distal portion of the inflatable member being sealed to a portion of the conduit and/or another member positioned on, attached to, and/or formed with or on the conduit. In still other various embodiments, distal portions of the inflatable member can be sandwiched between the member positioned on, attached to, or integrally formed with or on the conduit and a portion of the conduit, for example. In one embodiment, the inflation conduit can comprise an inner diameter or perimeter larger than the outer diameter or perimeter of the conduit to allow the fluid from the fluid source to flow or be pumped into and out of the inflatable member. The fluid from the fluid source can flow or be pumped through a void created between the outer diameter or perimeter of the conduit and the inner diameter or perimeter of the inflation conduit, for example. In other embodiments, the flow of the fluid can at least partially displace the outer surface of the conduit and the inner surface of the inflation conduit to flow to the inflatable member. In any event, a distal portion of the inflation conduit can be attached or sealed to and in fluid communication with the proximal portion of the inflatable member with a distal portion of the inflatable member being attached or sealed to a portion of the conduit or to a member positioned on, attached to, or integrally formed on or with the conduit such that the inflatable member can be inflated by the fluid. In other various embodiments, the inflation conduit can be eliminated and end portions of the inflatable member can be sealed to the conduit. In such an embodiment, the conduit can be in fluid communication with the fluid source at its proximal portion and can be in fluid communication with the inflatable member at its distal portion through an opening, aperture, slot, or perforation (not illustrated) in the conduit. As a result, the fluid from the fluid source can be flowed or pumped into the conduit and through the opening, aperture, slot, or perforation, which can be in fluid communication with an internal area of the inflatable member to inflate the inflatable member.
One problem encountered by various devices is that the uninflated inflatable member is not protected while it is being fed through the overtube, the working channel of the endoscope, and/or while it is being advanced through the opening in the tissue. As the inflatable member is made of a thin and flexible material, such as polyethylene terephthalate glycol, polyurethane, plastic, nylon, or combinations thereof, for example, it can be somewhat susceptible to tearing or puncturing. In one embodiment, the inflatable member can included longitudinally oriented pleats positioned about a perimeter of the inflatable member when the inflatable member is in a deflated configuration. In some instances, the inflatable member can tear, puncture, or become unpleated when it is contacted with a sharp end of the working channel, for example.
Further, the inflatable member can sometimes at least partially inflate prior to being positioned within the opening in the tissue owing to subatmospheric pressure conditions within the overtube. These subatmospheric pressure conditions can cause the inflatable member to prematurely inflate if the inflatable member is in fluid communication with atmospheric pressure or with a space having a higher pressure than the subatmospheric pressure conditions within the overtube. Even if a valve is supplied between the inflatable member and an atmospheric pressure space, any fluid within the conduit and/or the inflation conduit may cause the inflatable member to at least partially inflate owing to the fluid remaining within the conduit and/or the inflation conduit intermediate the valve and the inflatable member. Such premature inflation can cause delays during a surgical procedure as a partially inflated inflatable member may not fit properly into the opening in the tissue. To at least partially alleviate or eliminate the above-referenced difficulties, a surgical access device is provided with a protective sleeve which can, in some circumstances, at least partially cover the inflatable member at appropriate times during a surgical procedure to prevent, inhibit, or at least minimize opportunities for tearing, puncturing, unpleating, and/or premature inflation of the inflatable member.
In various embodiments, referring to FIGS. 1 and 2, a surgical access device 10 is illustrated. The surgical access device 10 can comprise a conduit 12, a needle 14 configured to be positioned within and at least partially through the distal end of the conduit 12, an optional inflation conduit 15 surrounding at least a portion of the conduit 12, an inflatable member 16 attached to, sealed to, positioned on, surrounding, or integrally formed with or on an outer surface of a distal portion of the conduit 12, and a protective sleeve 18 optionally comprising a handle or handle device 20 on its proximal portion. The protective sleeve 18 is configured to be positioned at least partially over (i.e., at least partially cover) the inflatable member 16 at appropriate times during a surgical procedure to protect and shield the inflatable member 16 from tearing, puncturing, unpleating, and/or premature inflation, for example. In at least one embodiment, the surgical access device 10 can be inserted into and extend through a distal end of a working channel of an endoscope positioned within an overtube, as described in further detail below. In various embodiments, the surgical access device 10, via its various components, can be used to puncture tissue to create an opening therein and then expand the opening using the inflatable member 16, such that an overtube, the endoscope, and/or another surgical instrument or device can be advanced distally through the opening to gain access to a surgical site.
In various embodiments, referring to FIGS. 1-4, the conduit 12 can comprise a hollow elongate opening therethrough and can be long enough to extend from outside of a natural opening in the patient's body to a surgical access site and/or the surgical site. The conduit 12 may be formed of or may comprise a flexible material to allow at least its distal portion to travel through the tortuous path within the patient's body to and at least partially through the opening in the tissue. The needle 14 can be sized and configured to fit and be slidable within the hollow elongate opening in the conduit 12. In use, the needle 14 can be inserted into the proximal end of the conduit 12 and fed through the conduit 12 until it extends from the distal end of the conduit 12. As referenced above, the needle 14 can be used to create, puncture, pierce, incise, and/or cut the opening in the tissue.
Further to the above, still referring to FIGS. 1-4, at least portions of the inflatable member 16 can be integrally formed with, integrally formed on, positioned on, sealed to, or attached to the outer surface of the distal portion of the conduit 12. In various embodiments, the inflatable member 16 can fully or partially surround the distal portion of the conduit 12 while the inflation conduit 15 can surround at least portions of the conduit 12 between the fluid supply 22 or tube 21 and the proximal portion of the inflatable member 16. As the inflatable member 16 can surround the distal portion of the conduit 12, it may have a larger, or slightly larger, perimeter or diameter than the perimeter or diameter of the conduit 12 it its uninflated state. Likewise, as the inflation conduit 15 can surround a portion of the conduit 12, it can have a larger, or slightly larger, perimeter or diameter than the perimeter or diameter of the conduit 12. In one embodiment, the inflatable member 16 can also comprise a plurality of longitudinally oriented pleats 17. These pleats 17 can be positioned about the perimeter or diameter of the inflatable member 16, as illustrated in FIG. 2. In some instances, it can be important to maintain the pleats 17 when the inflatable member 16 is in the uninflated position to enable to the inflatable member 16 to be properly inflated. It will be appreciated that more than one inflatable member can be used with the surgical access device 10 as is recognized by those of ordinary skill in the art. Further, the inflatable member can comprise any suitable inflatable member or inflatable members known to those of ordinary skill in the art.
In at least one embodiment, the inflatable member 16 can be in fluid communication with a fluid source 22 configured to provide a fluid to fill or inflate the inflatable member 16 at an appropriate time during the surgical procedure. In various embodiments, the fluid source 22 can be in fluid communication with the inflatable member 16 through the conduit 12 and an aperture in the conduit which is in fluid communication with the inflatable member 16. In other embodiments, the fluid source 22 can be in fluid communication with the inflatable member 16 through the inflation conduit 15 and an optional tube 21 connecting the fluid source 22 and the inflation conduit 15. As discussed above, the inflation conduit 15 can extend at least from the proximal portion of the inflatable member 16 to the tube 21 (or the inflatable member 15 can extend directly to the fluid source 22) and can have an inner diameter or perimeter larger than the outer diameter or perimeter of the conduit 12. As such, a void can be formed intermediate the inner surface of the inflation conduit 15 and the outer surface of the conduit 12. The inflatable member 16 can also be attached or sealed with the conduit 12 or other member 13 on the conduit 12 at its distal portion and can be in fluid communication with the inflation conduit 15 at its proximal portion such that the inflatable member 16 can be inflated by the fluid source 22. The fluid from the fluid source 22 can then be flowed or pumped through the tube 21, through the void, and then into the inflatable member 16 to inflate the inflatable member 16. In one embodiment, the inflation conduit 15 can be attached to a portion of the conduit 12 such that as the conduit 12 is advanced distally, in the direction indicated by arrow “B” of FIG. 2, the inflation conduit 15 is also advanced distally, in the direction indicated by arrow “B” of FIG. 2.
In various embodiments, the inflation of the inflatable member 16 can be controlled via a control unit (not illustrated) external to the patient that can be operated by the surgeon. In other embodiments, the inflatable member 16 can be inflated by the surgeon activating a manual pump or other suitable inflation device (not illustrated), for example. In various embodiments, the inflatable member 16 can be filled with a fluid in liquid or gas form, such as saline, air, water, and/or carbon dioxide, for example, as such fluids are common to the patient's body and can be easily absorbed and/or exhausted by the body. In various embodiments, as the inflatable member 16 is filled with the fluid, the inflatable member 16 can expand radially outward from the conduit 12 to enlarge the size of the opening in the tissue. It will be appreciated that the inflatable member 16 could also expand in any other suitable fashion depending on the configuration of the inflatable member 16 and the particular surgical need.
In various embodiments, referring to FIGS. 1-6, the protective sleeve 18 can be movable between a first position (see e.g., FIG. 1), where it can cover, or at least partially cover, the uninflated inflatable member 16, and a second position (see e.g., FIG. 2), where it can at least partially expose the inflatable member 16 for inflation. In at least one embodiment, a surgeon can slide the protective sleeve 18 between the first position and the second position (or into any other suitable intermediate position) by applying a proximal-to-distal force to the protective sleeve 18, in the direction indicated by arrow “B” of FIG. 2 (i.e., pushing), or by applying a distal-to-proximal force, in the direction indicated by arrow “A” of FIGS. 1 and 2 (i.e., pulling), to the protective sleeve 18. An optional handle device 20 may be integrally formed with or on or attached to a proximal portion of the protective sleeve 18 to facilitate slidable movement of the protective sleeve 18 relative to the conduit 12. It will be appreciated by those of ordinary skill in the art that any suitable handle or gripping device can be used with the surgical access device 10. Further, the handle device 20 can be eliminated and the surgeon can instead directly grasp the proximal portion of the protective sleeve 18 to move the protective sleeve 18 between the first and the second positions and any other suitable positions.
In one embodiment, the protective sleeve 18 may be slidably coupled to the conduit 12 and/or to the inflation conduit 15 in any suitable manner. For example, the protective sleeve 18 may be frictionally engaged with the conduit 12 and/or the inflation conduit 15 or may be otherwise slidably coupled to the conduit 12 and/or the inflation conduit 15. In one embodiment, the protective sleeve 18 and/or the handle 20 of the protective sleeve 18 and the conduit 12 and/or the inflation conduit 15 may be threadably connected, for example. The protective sleeve 18 and/or the handle 20 can have female threads formed on an inner surface thereof and the conduit 12 or the inflation conduit 15 can have male threads formed on an outer surface thereof such that the threads on the protective sleeve 18 and/or the handle 20 can engage the threads on the outer surface of the conduit 12 or the inflation conduit 15 and thereby advance, in the direction indicated by arrow “B” of FIG. 2, or retract, in the direction indicated by arrow “A” of FIGS. 1 and 2, when either the protective sleeve 18, the handle 20, the conduit 12, and/or the inflation conduit 15 is rotated by the surgeon. It will be appreciated by those of ordinary skill in the art that any other suitable mechanical members can be used to advanced and/or retract the protective sleeve 18 with respect to the conduit 12 and/or the inflation conduit 15. In other various embodiments, the advancement and retraction of the protective sleeve 18 can be automated through the use of at least one actuator, for example. For additional clarity, FIG. 6 illustrates a cross-sectional view taken along line 6-6 of FIG. 1 to illustrate how the protective sleeve 18, the inflatable member 16, the inflation conduit 15, the conduit 12, and the needle 14 can be situated when the protective sleeve 18 is in the first position. As referenced above, in various embodiments, the needle 14 can be hollow, for example.
In various embodiments, the protective sleeve 18 can have an inner diameter or perimeter which is larger than a respective outer diameter or perimeter of the conduit 12, the inflation conduit 15, and the uninflated inflatable member 16 to enable the protective sleeve 18 to at least partially or fully surround and slide over a portion of the conduit 12, a portion of the inflation conduit 15, and/or at least a portion the uninflated inflatable member 16. In at least one embodiment, apertures, cut-outs, slots, and/or joints may be formed on the protective sleeve 18 to make the device lighter and/or for various surgical reasons, such as, for example, to add flexibility to the protective sleeve 18 and/or to facilitate the steerability of the protective sleeve 18. Also, the protective sleeve 18 can be formed of or comprise a transparent or semi-transparent material (see e.g., FIG. 4). In at least one embodiment, the protective sleeve 18 may be formed of or may comprise a lubricious, low coefficient of friction material, such as polyethylene, polyetheretherketone (PEEK®), polytetrafluoroethylene (TEFLON®), plastic, nylon, ethylene, and/or a combination thereof, for example, to enable easy sliding movement of the protective sleeve 18 over the conduit 12, the inflation conduit 15, and/or the uninflated inflatable member 16. In such an embodiment, the lubricious, low coefficient material can also help prevent, inhibit, or at least minimize any opportunities for the protective sleeve 18 from tearing or puncturing the uninflated inflatable member 16 when sliding over the uninflated inflatable member 16 and/or when sliding from between the first position and the second position and/or into any suitable intermediate position. In various embodiments, the protective sleeve 18 further can at least inhibit unpleating of the pleats 17 of the inflatable member 16 when the protective sleeve 18 is in the first position thereby leading to more uniform inflation of the inflatable member 16. In various embodiments, the protective sleeve 18 can be flexible as required for traveling along the tortuous path inside the patient's body to the surgical site or surgical access site. In other various embodiments, portions of the protective sleeve 18 can be flexible while other portions can be rigid or semi-rigid, for example. As previously discussed, the protective sleeve 18 may comprise additional features to enhance its flexibility and/or steerability.
FIGS. 7-11 illustrate the surgical access device 10 at various stages of deployment through a cross-section of tissue 32. In use, the surgical access device 10 can be configured to be slidably received within an overtube 24 and an endoscope 26 comprising at least one working channel 28. The endoscope 26 can be any suitable endoscope known to those of ordinary skill in the art. In various embodiments, the overtube 24 can first be inserted into a natural orifice of a patient's body. In at least one embodiment, the endoscope 26 can then be positioned within and extend at least partially through the overtube 24 or extend to or from a distal end 30 of the overtube 24. In at least one embodiment, the distal end 30 of the overtube 24 can engage the tissue 32 and can apply suction to the tissue 32 owing to the subatmospheric pressure conditions created within the overtube 24. The overtube 24 can be in fluid communication with any suitable suction source such as a vacuum pump, for example, (not illustrated) or other suitable vacuum producing device. At least one appropriate end seal (not illustrated) may be provided to maintain the subatmospheric pressure conditions within the overtube 24. These subatmospheric pressure conditions within the overtube 24 can cause a portion of the tissue 32 proximate to a surgical access site to be pulled or drawn into the overtube 24 to locate the tissue 32 for puncturing by the needle 14 portion of the surgical access device 10. The suction applied to the tissue 32 at the distal end 30 of the overtube 24 can at least partially offset any proximal-to-distal (i.e., pushing) force, in the direction indicated by arrow “B” of FIG. 2, being applied to the tissue 32 when the needle 14 or surgical access device 10 is advanced through the tissue 32.
As referenced above, if the proximal end of the conduit 12 and/or inflation conduit 15 is open to atmospheric pressure (i.e., not sealed), or even if the conduit 12 and/or the inflation conduit 15 comprises a valve and/or a seal at a proximal portion thereof, the inflatable member 16 could still, at least partially, prematurely inflate owing to the subatmospheric pressure conditions within the overtube 24. As previously discussed, premature inflation of the inflatable member 16 can cause the inflatable member 16 to be enlarged such that it may not fit within the opening in the tissue 32 created by the needle 14. To address this issue, the protective sleeve 18 may be located in the first position to prevent, inhibit, or at least minimize such premature inflation from occurring by containing the inflatable member 16 within the elongate opening of protective sleeve 18 and thus inhibiting, for example, the inflatable member 16 from expanding outwardly relative to the conduit 12 prior to an appropriate time during a surgical procedure. Stated another way, the protective sleeve 18 can surround the inflatable member 16 closely enough to at least inhibit the inflatable member 16 from prematurely inflating. Furthermore, to any extent that the inflatable member 16 may partially inflate due to the tolerances of manufacturing, the inflatable member 16 can be contained within the hollow elongate opening defined by the protective sleeve 18 and, thus, can be inhibited from inflation by the protective sleeve 18, for example.
Further to the above, referring to FIGS. 7 and 8, while the suction is applied to the tissue 32 by the overtube 24, the needle 14 can be advanced distally towards the tissue 32 to puncture or pierce the tissue 32 and create an initial “needle sized” opening 34 therein. The surgeon can accomplish this advancement by applying a proximal-to-distal (i.e., pushing) force, in the direction illustrated by arrow “B” of FIG. 2, to a proximal portion of the needle 14. Once the needle 14 has punctured or pierced the tissue 32 and has created the opening 34, the conduit 12 and thereby the inflatable member 16, owing to the inflatable member's position on or attachment to, for example, the distal portion of the conduit 12 and the relative stretchability of the tissue 32, can be advanced distally toward, into, and at least partially through the opening 34 in the tissue 32. This advancement can be accomplished by the surgeon applying a proximal-to-distal (i.e., pushing) force to the proximal portion of the conduit 12, in the direction indicated by arrow “B” of FIG. 2. During the advancement of the conduit 12 and the inflatable member 16, the protective sleeve 18 can also be advanced by the surgeon again applying a proximal-to-distal (i.e., pushing) force to the proximal portion of the protective sleeve 18 and/or to the handle device 20, in the direction indicated by arrow “B” of FIG. 2, to maintain the inflatable member 16 in a shielded or protected state (i.e., the first position). FIG. 8 illustrates one stage of deployment of the surgical access device 10 through the cross-section of tissue 32. As illustrated, the protective sleeve 18, along with the conduit 12 and the inflatable member 16, can be advanced at least partially through the opening 34 in the tissue 32 with the protective sleeve 18 in the first position to cover the uninflated inflatable member 16. In this manner, the protective sleeve 18 shields the uninflated inflatable member 16 and protects it from puncturing, tearing, and/or unpleating during the advancement stage of deployment. The protective sleeve 18 generally should be advanced through the opening 34 in the tissue 32 while in the first position, although the conduit 12 and the inflatable member 16 could be advanced through the opening 34 when the protective sleeve 18 is in the second position or in any other suitable intermediate position.
In various embodiments, referring to FIG. 9, once the protective sleeve 18, the conduit 12, and the uninflated inflatable member 16 are advanced through the opening 34 in the tissue 32, the protective sleeve 18 can be retracted into the second position. This retraction can be accomplished by the surgeon applying a distal-to-proximal (i.e., pulling or retracting) force, in the direction indicated by arrow “A” of FIGS. 1 and 2, to the proximal portion of the protective sleeve 18 and/or to the optional handle device 20. As illustrated in FIG. 9, when the protective sleeve 18 is retracted into the second position, the inflatable member 16 can be exposed such that it can be inflated via the conduit 12 or inflation conduit 15 and the fluid source 22 to expand the opening 34 in the tissue 32.
In various embodiments, referring to FIGS. 10 and 11, before the inflatable member 16 is inflated, however, the distal end 30 of the overtube 24 can optionally be withdrawn from contact with the tissue 32 to alleviate, eliminate, or at least minimize the suction being applied to the tissue 32. Alternatively, the vacuum source could be powered off, for example, while maintaining the distal end 30 of the overtube 24 in contact with or proximate to the tissue 32. The fluid supply 22 (see e.g., FIGS. 1, 2, and 4) can then flow a fluid into the inflatable member 16 through the inflation conduit 15 to inflate the inflatable member 16. Alternatively, the fluid could be flowed through the conduit 12, as discussed above. As the inflatable member 16 is filled with the fluid, the inflatable member 16 can apply a force to the sidewalls 36 of the opening 34 created in the tissue 32 to radially or otherwise expand the opening 34 given the relatively elastic properties of the tissue 32. This expansion can continue until the opening 34 is large enough to accommodate the distal portion of the overtube 24, the distal portion of the endoscope 26, and/or a distal portion of other surgical instruments therethrough, for example.
In various embodiments, referring to FIG. 11, the inflatable member 16 can be inflated to a size that is similar to, the same as, slightly smaller than, and/or slightly larger than a diameter or a perimeter of the overtube 24. In various embodiments, a proximal portion of the inflatable member 16 can be at least partially inflated within the distal end 30 of the overtube 24 such that the overtube 24 can easily be advanced distally through the tissue 32 without tearing the tissue or to at least minimize tearing of the tissue 32, owing to the similarity of the diameter or perimeter of the overtube 24 and the diameter or perimeter of the inflatable member 16, for example. In other various embodiments, the inflatable member 16 can be inflated to a size that is similar to, the same as, slightly smaller than, and/or slightly larger than a diameter or a perimeter of the endoscope 26, for example, such that the endoscope 26 can be advanced through the tissue 32 in a similar manner as the overtube 30 described above.
Once the opening 34 is expanded to a suitable size by the inflatable member 16 and/or the overtube 24 and/or the endoscope 26 are advanced partially through the opening 34, the fluid can be withdrawn, pumped, or otherwise removed from the inflatable member 16 and flowed back into the fluid supply 22 through inflation conduit 15 or the conduit 12. After a sufficient amount of the fluid, or substantially all of the fluid, is withdrawn from the inflatable member 16, the surgical access device 10 can be withdrawn from the working channel 28 of the endoscope 26. Withdrawal of the surgical access device 10 from the working channel 28 allows other surgical instruments or devices to be inserted into the working channel 28 and extended from the distal end of the working channel 28 to obtain access to the surgical site through the opening 34 in the tissue 32. It will be appreciated that endoscopes may comprise more than one working channel. Accordingly, other surgical instruments may be inserted through any of these additional working channels enabling the surgical access device 10 to remain in-situ, for example, during a surgical procedure.
In various embodiments, the overtube 24 can generally be flexible so as to allow navigation through the tortuous pathway of a body lumen during an endoscopic procedure. The size of the overtube 24 can vary but, in various embodiments, it can have a length that allows it to be inserted translumenally through a patient's esophagus and an inner diameter or perimeter suitable to receive the endoscope 26 therein. The overtube 24 can be made flexible using various techniques. For example, the overtube 24 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, for example. In other embodiments, the overtube 24 can be formed from a plurality of linkages that are movably coupled to one another. The overtube 24 can also include regions that vary in flexibility. For example, certain portions of the overtube 24, such as the distal portion, can be more rigid than other portions of the overtube 24, 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 24 from different materials, varying the diameter or thickness of the overtube 24, and/or using various other suitable techniques known to those of ordinary skill in the art. A person skilled in the art will appreciate that the overtube 24 can have virtually any configuration that allows the overtube 24 to flex as it is inserted through a tortuous body lumen. The overtube 24 can also include other features to facilitate use, such as one or more spiral wires embedded therein in a configuration to prevent kinking of the overtube 24 during flexure, for example. In various embodiments, the protective sleeve 18, the conduit 12, and/or the inflation conduit 15 can include any suitable features discussed above with respect to the overtube 24, for example.
The surgical access device 10 as described herein can have many uses. A non-limiting example of one particular use is described below with reference to FIGS. 12 and 13. In various embodiments, a flexible endoscopic portion 131 of an endoscope 160 (e.g., gastroscope) is inserted into an upper gastrointestinal tract of a patient. FIG. 12 illustrates the surgical access device 10 inserted through a natural orifice such as the mouth 110 and esophagus 112 into the stomach 114 to establish an opening in the stomach 114 for performing a surgical operation such as a gall bladder removal or a cholecystectomy, for example. FIG. 13 illustrates a distal portion 132 of the endoscope 160. As shown in FIGS. 12 and 13, the endoscope 160 may comprise the distal portion 132 and a proximal portion 140. In at least one embodiment, an overtube 130, configured to receive at least the endoscopic portion 131 of the endoscope 160, can be inserted into the mouth 110 and can extend towards and/or into the stomach 114. The overtube 130 can create a working channel for insertion of the endoscopic portion 131 of the endoscope 160. In various embodiments, the overtube 130 may be fabricated from nylon or high-density polyethylene plastic, for example. In various embodiments, the endoscopic portion 131 can define various working channels 138 that extend at least from the natural orifice 110 to the surgical site. In addition, the endoscopic portion 131 may define a viewing port 136, for example. As such, the endoscope 160 may be used for viewing the surgical site within the patient's body. Various cameras and/or lighting apparatuses may be inserted into the viewing port 136 of the endoscope 160 to provide the surgeon with a view of the surgical site.
In the embodiment illustrated in FIG. 12, one of the tools, devices, or surgical instruments that can be accommodated in the working channels 138 is a hollow vacuum/air tube 150 that may be in fluid communication with a fluid source such as at least one of a vacuum source 152 and a pressurized air source 154. In one embodiment, the vacuum/air tube 150 can be sized to receive therein another surgical instrument in the form of the endoscope 160. A variety of different types of endoscopes are known and, therefore, their specific construction and operation will not be discussed in great detail herein. In various embodiments, the endoscope 160 may operably support a video camera that communicates with a video display unit 164 that can be viewed by the surgeon during the surgical procedure. In addition, the endoscope 160 may further comprise a fluid-supply lumen therethrough that is coupled to a source of water 172, saline solution, and/or any other suitable fluid and/or an air supply lumen that is coupled to a source of air 178.
In use, the surgical access device 10 can be inserted into one of the working channels 138 through either working channel port 141 or 143 and then through either working channel tube 146 or 147 to working channel 138 and used to puncture, pierce, create, or incise an opening in tissue “T” proximate to the surgical site. As illustrated in FIGS. 12 and 13, a portion of the surgical access device 10 can extend from the distal end of the working channel 138 to enable access to the tissue “T.” In various embodiments, the surgical access device 10 can function as explained herein.
In various embodiments, again referring generally to the various stages of deployment illustrated in FIGS. 7-11, a method of using the surgical access device 10 is provided. First, the surgeon can insert an overtube 24 into a natural opening of a patient, such as the mouth, for example. The surgeon can then either insert a portion of the endoscope 26 into the overtube 24 or can simply insert the surgical access device 10 into the overtube 24. In many instances, the surgeon may insert the portion of the endoscope 26 before inserting the surgical access device 10 to allow the surgeon to view the surgical site via a viewing port of the endoscope 26. In such an instance, the surgeon can position the surgical access device 10 within and at least partially through the working channel 28 of the endoscope 26. As the surgical access device 10 is inserted into the working channel 28 or the overtube 24, the protective sleeve 18 can be in the first position where it at least partially covers, shields, and protects the uninflated inflatable member 16 to prevent, inhibit, or at least minimize tearing, puncturing, and/or unpleating of the uninflated inflatable member 16 during insertion. Once a distal end of the surgical access device 10 reaches the surgical site, the surgeon can then turn on a vacuum producing device to create negative pressure conditions or subatmospheric pressure conditions within the overtube 24. These conditions within the overtube 24 can cause a portion of the tissue 32 near the surgical access site or surgical site to be at least partially drawn into the distal end of the overtube 24 such that the portion of the tissue 32 can be punctured by the needle 14 of the surgical access device 10.
To puncture the portion of the tissue 32, the surgeon can advance the distal end of the needle 14 into and insert it through the portion of the tissue 32 by applying a proximal-to-distal (i.e., pushing) force, in the direction indicated by arrow “B” of FIG. 2, to the proximal portion of the needle 14. After the needle 14 has created the opening 34 in the tissue 32, the surgeon can then advance the distal end of the conduit 12 into and through the opening 34 by applying a proximal-to-distal (i.e., pushing) force, in the direction indicated by arrow “B” of FIG. 2, to the proximal portion of the conduit 12. In such an embodiment, the surgeon can also apply a proximal-to-distal (i.e., pushing) force to the handle device 20 or proximal portion of the protective sleeve 18 to ensure that the protective sleeve 18 remains in the first position during insertion of the distal end of the conduit 12 into and at least partially through the opening 34 in the tissue 32. In other various embodiments, a portion of the protective sleeve 18 can be releasably engaged with a portion of the conduit 12 or a portion of the inflation conduit 15 to prevent, inhibit, or at least minimize sliding of the protective sleeve 18 at inappropriate times during the surgical procedure. As discussed previously, by maintaining the protective sleeve 18 in the first position during insertion into the opening 34 in the tissue 32, the uninflated inflatable member 16 can be substantially protected from puncturing, tearing, unpleating, and/or premature inflation under subatmospheric pressure conditions within the overtube 24. Next, the surgeon can move and/or retract the protective sleeve 18 from the first position to a second position thereby exposing the inflatable member 16 to the sidewalls 36 of the opening 34. As discussed above, the protective sleeve 18 can be moved using the handle device 20 or by pushing or pulling the proximal portion of the protective sleeve 18, for example. Also, as discussed above, this movement of the protective sleeve 18 can be accomplished through the use of other mechanical members, such as threads, for example, or through suitable automated members, for example.
Once the protective sleeve 18 has been retracted into the second position, the surgeon can then activate the fluid supply 22 to begin filling the inflatable member 16 via the inflation conduit 15 or the conduit 12, as discussed above. Filling the inflatable member 16 can cause the opening 34 in the tissue 32 to be enlarged as the inflatable member 16 applies a force to the sidewalls 36 of the opening 34 during expansion. Once the opening 34 has been sufficiently expanded and the inflatable member 16 has been deflated, the surgeon can remove the surgical access device 10 from the overtube 24 or working channel 28 and insert appropriate surgical instruments or devices to begin or continue a surgical procedure.
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 devices can be reconditioned for reuse after at least one use. Reconditioning can include any combination of the steps of disassembly of the devices, followed by the cleaning or replacement of particular pieces, and subsequent reassembly. In particular, the devices can be disassembled, and any number of the particular pieces or parts of the devices can be selectively replaced or removed in any combination. Upon the cleaning and/or replacement of particular parts, the devices 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 the devices can utilize a variety of techniques for disassembly, cleaning/replacement, and reassembly. The use of such techniques, and the resulting reconditioned devices, 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 device 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 device and in the container. The sterilized device can then be stored in the sterile container. The sealed container keeps the device 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 surgical access device sized to fit in a working channel of an endoscope and configured to be advanced through a tissue opening to a surgical site, comprising:
a conduit comprising a proximal end and a distal end;
an inflatable member at least partially surrounding a portion of the conduit and positioned proximate to the distal end of the conduit; and
a protective sleeve at least partially surrounding a portion of the conduit and configured to translate within the working channel of the endoscope, the protective sleeve configured to be moved at least between a first position and a second position, the protective sleeve configured to at least partially cover the inflatable member when in the first position and configured to expose the inflatable member when in the second position, the protective sleeve configured to be in the first position when the inflatable member is advanced through the tissue opening to the surgical site.

2. The surgical access device of claim 1, the protective sleeve configured to cover the inflatable member when the protective sleeve is in the first position.

3. The surgical access device of claim 1, comprising a handle device one of attached to and integrally formed with the protective sleeve and positioned near a proximal end of the protective sleeve.

4. The surgical access device of claim 1, the protective sleeve comprised of a low-friction material configured to enable sliding over at least a portion of the inflatable member when moving between the first position and the second position.

5. The surgical access device of claim 1, wherein at least a portion of the conduit and at least a portion of the protective sleeve comprise a flexible material.

6. The surgical access device of claim 1, the conduit configured to receive therethrough at least one of a rotary needle, a veress needle, a cutting member, a puncturing member, a piercing member, and a guide wire.

7. The surgical access device of claim 1, the protective sleeve configured to shield the inflatable member and at least inhibit tearing or puncturing of the inflatable member prior to inflation when the protective sleeve is in the first position.

8. The surgical access device of claim 1, the protective sleeve configured to shield the inflatable member and at least inhibit tearing, puncturing or unpleating of the inflatable member during entry into, traveling within, or exiting from the working channel of the endoscope when the protective sleeve is in the first position.

9. The surgical access device of claim 1, the protective sleeve comprising an elongate passage comprising an inner perimeter sized to at least inhibit the inflatable member from inflating under subatmospheric pressure conditions when the protective sleeve is in the first position.

10. The surgical access device of claim 1, the conduit comprising a first outer perimeter, the inflatable member, in an uninflated state, comprising a second outer perimeter, wherein the second outer perimeter is larger than the first outer perimeter, the protective sleeve comprising an elongate channel comprising an inner perimeter, wherein the inner perimeter is larger than the second outer perimeter.

11. The surgical access device of claim 1, the inflatable member comprising at least two longitudinally oriented pleats positioned about the perimeter of the inflatable member, wherein the protective sleeve is configured to at least minimize unpleating of the pleats of the inflatable member when in the first position.

12. A method of using the surgical access device of claim 1, comprising:
inserting the surgical access device of claim 1 into a natural orifice of a patient with the protective sleeve in the first position; and
retracting the protective sleeve into the second position.

13. A surgical access device sized to fit in a working channel of an endoscope and configured to be passed through punctured tissue to gain access to a surgical site, comprising:
a conduit comprising a proximal end and a distal end;
a needle within the conduit, the needle configured to puncture tissue;
an inflatable member at least partially surrounding a portion of the conduit and positioned proximate to the distal end of the conduit; and
a protective sleeve at least partially surrounding a portion of the conduit and configured to translate within the working channel of the endoscope, the protective sleeve moveable at least between a first position, where the protective sleeve at least partially covers the inflatable member, and a second position, where the inflatable member is exposed, the protective sleeve configured to be in the first position when the inflatable member is passed through the punctured tissue to the surgical site, the protective sleeve comprising an elongate channel comprising an inner perimeter sized to at least inhibit the inflatable member from inflating under subatmospheric pressure conditions when the protective sleeve is in the first position.

14. The surgical access device of claim 13, the protective sleeve configured to cover the inflatable member when the protective sleeve is in the first position.

15. The surgical access device of claim 13, comprising a handle device one of attached to and integrally formed with the protective sleeve and positioned near a proximal end of the protective sleeve, the handle device configured to be used to move the protective sleeve between the first position and the second position.

16. The surgical access device of claim 13, the protective sleeve configured to shield the inflatable member and at least inhibit tearing, puncturing, or unpleating of the inflatable member prior to inflation when the protective sleeve is in the first position.

17. The surgical access device of claim 13, the conduit comprising a first outer perimeter, the inflatable member, in an uninflated state, comprising a second outer perimeter, wherein the second outer perimeter is larger than the first outer perimeter, the protective sleeve comprising an elongate channel comprising an inner perimeter, wherein the inner perimeter is larger than the second outer perimeter.

18. A surgical access device sized to fit in a working channel of an endoscope and configured to be advanced through a tissue opening, comprising:
a conduit comprising a proximal portion and a distal portion, wherein the conduit is configured to receive a needle;
an inflatable member at least partially surrounding a portion of the conduit and positioned proximate to the distal portion of the conduit, the inflatable member comprising an outer perimeter in an at least partially uninflated state; and
a sleeve at least partially surrounding a portion of the conduit and configured to translate within the working channel of the endoscope, the sleeve comprising an elongate channel comprising an inner perimeter larger than the outer perimeter, the sleeve moveable at least between a first position and a second position, the sleeve configured to shield the inflatable member and inhibit tearing or puncturing of the inflatable member when the sleeve is in the first position, and the sleeve configured to expose the inflatable member for inflation when the sleeve is in the second position, the protective sleeve configured to be in the first position when the inflatable member is advanced through the tissue opening.

19. The surgical access device of claim 18, the sleeve configured to cover the inflatable member when the sleeve is in the first position to at least inhibit the inflatable member from inflating under subatmospheric pressure conditions.