WO2018098477A1

WO2018098477A1 - Urologic sheath with photodiode and coaxial grabber for suctioning of larger kidney stones

Info

Publication number: WO2018098477A1
Application number: PCT/US2017/063460
Authority: WO
Inventors: Joshua W. SAPPENFIELD; Vincent G. BIRD; Nikolaus Gravenstein
Original assignee: University Of Florida Research Foundation, Incorporated
Priority date: 2016-11-28
Filing date: 2017-11-28
Publication date: 2018-05-31

Abstract

Endoscope sheaths having a larger diameter than the working lumen on an endoscope are provided. The sheath can include a working lumen capable of being used to apply suction, as well as a light, camera, and irrigation capabilities that allow it to be used in place of an endoscope. Additional features include a working tip capable of being manipulated, a screen for limiting the size of objects taken into the working lumen, and one or more mechanisms for controlling the operations of the sheath. The endoscope sheath can be used to remove larger kidney stones by suction.

Description

DESCRIPTION

UROLOGIC SHEATH WITH PHOTODIODE AND COAXIAL GRABBER FOR SUCTIONING OF LARGER KIDNEY STONES

CROSS-REFERENCE TO RELATED APPLICATION This application claims the benefit of U.S. Provisional Application Serial No. 62/426,794, filed November 28, 2016, the disclosure of which is hereby incorporated by reference in its entirety, including any figures, tables, and drawings.

BACKGROUND

The process of removing stones from the urinary tract usually requires an initial procedure, such as lithotripsy, to break the stones into smaller pieces that can be more easily removed from the kidney or bladder. Once the stones have been broken into a more manageable size, an endoscope can be inserted in a percutaneous fashion into the renal pelvis and calyces, or alternatively, transurethrally, into the bladder. Endoscopes often have illumination and camera features that allow the cavities in the kidney or bladder to be seen. Many endoscopes also have an integral working or suction lumen to which a vacuum apparatus can be attached to suction out the stone pieces. However, this channel is often relatively small caliber. Stone fragments can only be practically suctioned through larger caliber channels. As such, larger fragments are often mechanically removed. Smaller fragments may be suctioned through a rigid device, though this still has limitation including caliber of diameter, and inaccessibility to regions in the urinary tract not in line with the rigid device and its line of access. If the stone pieces are not removed, and they do not drain on their own, it may be necessary to subject the patient to another lithotripsy treatment. A limiting factor in the size of the stone pieces that can be removed is at times related to the diameter of the suction lumen, which, in the case of a flexible endoscope, is usually narrower at the part of the endoscope that can bend.

The current common paradigm for endoscopes includes incorporation of the all elements in the scope, including optical apparatus, working channels, and deflection mechanisms in flexible endoscopes. Once utilized, an endoscope has to undergo an extensive cleaning and sterilization process before reuse, which wears on the instrument and limits the useful life. Sheaths may be used on an endoscope to protect the endoscope during use and eliminate the need for extensive cleaning of the endoscope. However, the sheaths can interfere with the operation of the endoscope. If the endoscope is removed from the sheath, many of the features provided by the endoscope, such as lights and cameras for visualization within the kidney and deflection capabilities of the tip within the kidney, are lost. Most sheaths also do not include connectors for attaching a suction apparatus.

BRIEF SUMMARY

Embodiments of the subject invention successfully address the above described disadvantages associated with the previously known endoscope sheathing devices and methods of using them for removal of kidney stones, and provide certain attributes and advantages, which have not been realized by these known sheathing devices. In particular, embodiments of the subject invention provide novel and highly effective devices and methods for suctioning kidney stones with an endoscope sheath with or without removal of the endoscope from the sheath.

In accordance with embodiments of the subject invention, the problem of using an endoscope to suction kidney stones in vivo with an endoscope is solved by engendering an endoscope sheath with features similar to those of an endoscope. In this way, the sheath can be placed like an endoscope into the appropriate location within a kidney. The endoscope sheath can also have additional lumens that can be used for irrigation of the kidney cavity, as well as a light and/or a camera for more effective removal of the kidney stone pieces. A grasper apparatus can also be included, which can be used to pull stones closer to the tip sheath for removal or, if necessary, further breaking with a laser.

Flexible endoscopes have at least a portion of the working length that can bend.

There is also usually a deflection apparatus configured into the endoscope that can be used to manipulate the end of the endoscope. Endoscope sheaths of embodiments of the subject invention can also be engendered with at least a portion of the working length that can bend and that can be manipulated with any of a number of known deflection apparatuses. BRIEF DESCRIPTION OF DRAWINGS

Figure 1 is an illustration of a sheath according to an embodiment of the subject invention.

Figures 2A and 2B are illustrations of a side view (Figure 2A) and a front view

(Figure 2B) of a working tip of a sheath according to an embodiment of the subject invention.

Figure 3 is an illustration of a working tip of a sheath placed in vivo and utilized to suction material from a body cavity, according to an embodiment of the subject invention.

Figure 4 is an illustration of a working tip that shows an accessory lumen with a grasper, according to an embodiment of the subject invention.

DETAILED DESCRIPTON

Embodiments of the subject invention pertain to endoscope sheaths for use in removing kidney stones. More specifically, embodiments of the subject invention provide sheaths that can be placed within the renal pelvis, calyx, or urinary bladder, either independently or with the initial assistance of an endoscope, or similar device, where the sheath can be used to suction kidney stones or pieces of kidney stones from the kidney. Still more specifically, the sheath can include light and optical fixtures, in addition to the suctioning capabilities. An irrigation lumen can also be included to provide fluid into a cavity, which can facilitate suctioning of material. These features being provided on a sheath allows the endoscope to be removed from the sheath, and the kidney stones or kidney stone pieces can be visualized with and suctioned through the sheath. Advantageously, the suction lumen of the sheath can have a larger diameter than that typically provided in endoscopes, allowing the removal of larger stones. The sheath can also include a grate that funnels larger stones towards an access port, which is capable of supporting a laser, allowing further destruction of stones that may clog or obstruct suctioning through the sheath.

Embodiments of the subject invention are particularly useful in the field of urologic endoscopy, in particular devices, such as endoscopes, used for the treatment and/or removal of kidney stones from kidneys. However, a person with skill in the art will be able to recognize numerous other uses that would be applicable to the devices and methods of embodiments of the subject invention. While the subject application describes, and many of the terms herein relate to, a use for removal of kidney stones, modifications for other uses and access to other body cavities, apparent to a person with skill in the art and having benefit of the subject disclosure, are within the scope of embodiments of the present invention.

In the description that follows, a number of terms used in urological endoscopy are utilized. In order to provide a clear and consistent understanding of the specification and claims, including the scope to be given such terms, the following definitions are provided.

The term "patient" as used herein, describes an animal, including mammals (e.g., humans), to which the systems and methods of embodiments of the present invention are applied. Mammalian species that can benefit from the disclosed systems and methods include, but are not limited to, apes, chimpanzees, orangutans, humans, monkeys; domesticated animals (e.g., pets) such as dogs, cats, guinea pigs, and hamsters, veterinary uses for large animals such as cattle, horses, goats, and sheep, and any wild animal for veterinary or tracking purposes.

The term "surgeon" as used herein is merely for literary convenience. The devices, apparatuses, methods, techniques and/or procedures of embodiments of the subject invention could be utilized by any person desiring or needing to do so and having the necessary skill and understanding of the invention.

The term "kidney stone" is also used for literary convenience. It is well-known in the field of urologic endoscopy that large kidney stones are often broken up, for example, using lithotripsy techniques, prior to removal. Thus, as used herein these terms can refer to an intact, unbroken, kidney stone, or the pieces of a kidney stone present after treatment to break the stone.

Also, as used herein, and unless otherwise specifically stated, the terms "operable communication," "operable connection," "operably connected," "cooperatively engaged" and grammatical variations thereof mean that the particular elements are connected in such a way that they cooperate to achieve their intended function or functions. The "connection" or "engagement" may be direct, or indirect, physical or remote.

Reference may be made throughout the application to the "proximal end" and

"distal end." As used herein, the distal end is that end that is typically placed within a patient, and the proximal end of the device is that end that typically remains outside the patient or near the operator.

Embodiments of the present invention are more particularly described in the following examples, and embodiments that are intended to be illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art. As used in the specification and in the claims, the singular for "a," "an" and "the" include plural referents unless the context clearly dictates otherwise.

Reference will be made to the attached figures on which the same reference numerals are used throughout to indicate the same or similar components. With reference to the attached figures, which show certain embodiments of the subject invention, it can be seen that an endoscope sheath 50 of an embodiment of the subject invention can have a bendable shaft 100 with a proximal end 10 and a distal end 5, where the proximal end can include operational apparatuses 200 for controlling or manipulating operations at a working tip 300, which is at the distal end 10 of the sheath. The bendable shaft can include a working lumen 110, as well as other lumens for various components to traverse the sheath and reach the working tip. Alternative embodiments can include a grasper 600 at the working tip that can be used to pull material closer to the suction opening on the working tip. Each of these general components can have one or more sub-components, which will be discussed in detail below.

Embodiments of the subject invention provide a sheath 50 for covering an endoscope during use. The sheath has a working tip 300 that can be manipulated or "steered" using deflector controls 220 to control mechanisms within the shaft 100 of the sheath that cause some portion of the distal end to bend or flex at an angle of 90°, about 90°, at least 90°, or up to 90°, relative to the shaft. Deflector controls and the mechanisms used therewith are known in the art, in particular in endoscopes. The ability to incorporate the same or similar types of controls and mechanisms with the sheath embodiments disclosed herein, to allow a surgeon to move and bend the working tip of the sheath, is within the capability of one of ordinary skill in the art and will not be described in detail here.

While an endoscope and a sheath can have similar features and operations, there are differences. A flexible endoscope is, for the most part, an optical instrument that carries light and some type of optical instrument into the body for observational purposes. It can have additional rudimentary functions like operating instruments or biopsy tools or it can have a general working channel into which a variety of other instruments can be inserted for direct access into the body. However, an endoscope is primarily an optical device that may have maneuverability, working channels, and are often small and of limited use. Endoscopes tend to be narrow with an outer diameter of between about 3.0 mm to about 6.0 mm. The working channel in an endoscope necessarily has a smaller diameter than the shaft and is usually between about 0.8 mm to about 1.2 mm. Thus, the size of an object that can be inserted into the working channels and the size of material, such as a kidney stone, that can be removed through the working channel is limited by the diameter of the working channel.

Conversely, the sheaths used to cover an endoscope during use often have larger diameters. However, they lack the other features and capabilities associated with endoscopes, including lights or optical or visualization devices. They have essentially only functioned as conduits for safe introduction of the scope into the patient, and have allowed for more facile re-entry. Thus, once an endoscope is removed from the sheath, the interior of the body area is usually not visible. Sheaths of embodiments of the subject invention combine the advantages of both of these devices into a single instrument that can be used alone or with other instruments, including endoscopes, to provide better treatment and easier removal of kidney stones.

In one embodiment, a sheath 50 has an at least partially bendable shaft 100 that can include an operational apparatus 200 comprising one or more deflector controls 220 at or about the proximal end 10 for bending, steering, directing, or otherwise manipulating the working tip 300 at the distal end 5 of the shaft. In a further embodiment, the sheath includes at least one working lumen 110 with an entryway 115 that originates at a point outside the body, which can be, but is not required to be, at or near the proximal end 10 of the sheath. Figure 1 illustrates a non-limiting example of this embodiment. In a particular embodiment, the entryway is located at a point that is between the approximate center 15 of the shaft and the proximal end 10. This alternative placement of the entryway is also shown with dashed lines in Figure 1. This placement can be beneficial if there are other structures or mechanisms located on or about the distal end of the shaft. A working lumen can also have an access port 320 that opens onto the working tip or at or about the distal end 5 and can provide access into the body or body cavity through the entryway 115. In general, an access port is the outside opening at the distal end 5 of a working lumen. One non-limiting example of this is shown in Figures 2A and 2B. Alternatively, the access port can open further back or more proximal to the working tip, either in addition to or instead of an access port right at the working tip.

In a further embodiment, the access port 320 leads to a working lumen 110 that is a channel, coaxial with the shaft, through which various instruments can be inserted to reach the body interior or body cavity. This can include an endoscope, which can be specifically used for guiding the sheath 50 and particularly the working tip 300 to a correct location in the body or for providing additional functionalities. There can be more than one working lumen in a sheath. A particular embodiment has two working lumens. Alternative embodiments can have three or more working lumens. The one or more working lumens can be employed for different purposes during a procedure. Typically, a working lumen is a channel through which devices can be inserted through to the body cavity. A working lumen can also have other uses, as described below.

Advantageously, the working lumen 110 can also be utilized as a suction channel through which material or objects in the body can be removed, one example of which is shown in Figure 3. A further advantage of utilizing the working lumen of a sheath as a suction channel is the consistent diameter, which can be larger than that usually provided by a sheath. Endoscopes used for suction often have a restriction or reduction in the diameter in the bendable portion of the endoscope shaft. However, sheaths are designed to receive an endoscope, so they typically have a consistent diameter along the entire length, which is necessarily larger than the diameter of the endoscope. Thus, once the endoscope is used to place the sheath in the body, the endoscope can be removed, leaving the sheath with a larger diameter in place.

In one embodiment, a vacuum connector 230 at or about the proximal end 10 of the sheath 50 can be operatively connected to the working lumen 110. A vacuum source 232 can be further connected to the vacuum connector to provide suction to the working lumen. An operational control apparatus 200, such as a vacuum regulator 235 can be used to control the vacuum force achieved at the access port 320 of the working lumen 110. Figure 1 illustrates a non-limiting example of a vacuum tube 232 in operative connection with a vacuum connector 230 operated with a valve regulator 235. It is known in the art that when a vacuum force is pulled along a channel it can cause the channel to collapse if the vacuum force is too powerful. In one embodiment, the working lumen 110 is coaxial with the shaft 100 and the working lumen and/or the shaft is sufficiently reinforced or rigid enough to withstand the vacuum forces necessary to take up kidney stones through the access port 320 of the working lumen, preferably without damaging surrounding tissue.

Sometimes it can be difficult to discern when an object or tissue is too large to be taken into the access port 320, which can cause the access port to get clogged or blocked before the control mechanism 235 can be used to turn off the vacuum force. This can be particularly problematic when retrieving kidney stones. One embodiment of the subject invention includes a screen 330 disposed over or within the access port 320 that allows only objects of a pre-determined size to enter the working lumen. This can inhibit clogging or blockage of the working lumen, while the larger diameter of the sheath 50 and the working lumen 110, as discussed above, can still provide the option of removing larger or more objects than can typically be removed by an endoscope. A screen can have a single pore 335 designed to permit objects up to a certain size to enter the lumen. Alternatively, a screen can have two or more pores 335 to allow multiple objects of a certain size to enter the working lumen 110. The ability to determine the pore size and configuration of a screen for use on the working tip 300 is within the skill of a person trained in the art and, as such, further details do not need to be described here. The screen is to be designed in such a way as to deflect debris that is suctioned from the access port 320 towards the channel 120. Channel 120 is capable of containing such lithotripsy devices such as a laser which will allow further breakage of the suctioned debris such that it could fit through the screen 330. Such variations that provide the same function, in substantially the same way, with substantially the same result, are within the scope of this invention.

Embodiments of the subject invention can have any number of lumens or working lumens into which objects, tools, devices or other features can be permanently or removably inserted therein. As mentioned above, there can be more than one working lumen, which can typically be utilized to allow insertion of different tools or instrument for access to the body or organ cavity. Other lumens can also run through all or a portion of a sheath and be used for more specialized purposes, as will be described below. Embodiments of the subject invention are not limited to a specific number of working lumens or other specialized lumens and not all lumens within a sheath must necessarily be utilized during a procedure.

The ability to vacuum or suction objects from a body cavity is often improved or enhanced when the objects are dislodged or disassociated from the surrounding tissue. This is often most easily achieved by irrigating or insufflating the body cavity to dislodge objects or even cause them to be suspended in the fluid (e.g., liquid or gas) for easier vacuum removal. One embodiment of the subject invention includes an irrigation lumen 500 capable of injecting any of a variety of fluids into the body or a body cavity. The irrigation lumen can be open at or about the working tip and traverse the shaft to an irrigation port 520 on a portion of the shaft outside the body. The irrigation port can be operably communicated to a fluid (e.g., liquid or gas) source, which can be controlled by an operational apparatus 200, such as a valve control mechanism 260.

As mentioned above, an endoscope often includes features for visualization of an area to be treated or materials or objects to be removed. Typically, when an endoscope is removed from a sheath, any operations conducted by or through the sheath are done blind. Alternatively, the endoscope has to be repeatedly placed within the working lumen of a sheath so the tip end can be properly positioned and then removed so that other devices can be used in the working lumen to conduct whatever procedure(s) is/are required.

In a further embodiment, a sheath 50 can includes apparatuses for in vivo visualization. These can include, but are not limited to, one or more lights and optical devices. In one embodiment, there is at least one light 340 operational at or about the working tip 300 of the sheath. A variety of lights can be utilized depending upon the procedure to be performed. One embodiment utilizes an LED light in the working tip. Another embodiment utilizes bundled fiber optic cables. In a further embodiment, the light can be attached to an operational apparatus 200 that is a light or power control 240 on the sheath portion outside the body. The power control can adjust the intensity or other qualities of the light that is emitted. Alternatively, the light can have a set illumination factor and can come on automatically when a particular event occurs, such as, for example, when the endoscope is removed from the working lumen.

Certain tissues or objects are more clearly seen under different light spectrums. For example, tissues that have been dyed or that have received certain types of systemic contrast media can be easier to see under specific light spectrums or different types of light. In one embodiment, a sheath has a single light source that emits a white light for general viewing. In an alternative embodiment, the single light 340 is configured so that the power control 240 can be used to change the light spectrum to achieve one or more different colors. In another embodiment, the sheath has two or more lights at the working tip 300, where each light emits a different lumen or wattage or, alternatively, emits light in one or more different colors. By way of non-limiting example, the working tip 300 can have an LED light capable of changing colors and an incandescent light source also capable of changing colors.

In a particular embodiment, all or at least part of the access port 320 and/or additional areas around the working tip 300 of the sheath 50 can be encircled by a ring of light. For example, a plurality of optical fibers or LED lights can be arranged around the access port or other parts of the working tip of the sheath. This can be advantageous should one part of the lighted access port or working tip be covered or blocked, another part of the access port or working tip with lights can still illuminate the area of interest.

If light is provided in a body area or body cavity, it can be advantageous to have an associated mechanism for actually capturing images of the objects being illuminated. Many embodiments of the subject invention can include an optical mechanism 400 for transmitting images outside the body. In one embodiment, the optical mechanism is a camera located at or about the working tip 300 that employs photodiodes or other apparatuses to obtain images and transmits them outside the body. The camera can transmit still images or video images or some combination thereof. In one embodiment, the camera is operatively connected through the shaft 100 to any of a variety of display devices 430 outside the body. In one particular embodiment, the camera is wired coaxially through the shaft to a transmitter 420 on a portion of the shaft outside the body. The transmitter can then emit one or more signals that generate an image on a display device 430, for example a computer monitor or television screen. Alternatively, the camera can be remotely connected to the viewing mechanism, such that one or more signals are transmitted from the camera to the display device without traversing the shaft to the outside of the body. For example, a standard short-wave wireless connection, colloquially referred to as "Bluetooth connection," can be utilized to operatively connect the camera in the body to the display device outside the body. In a further embodiment, the display device can record one or more images received by the camera or other optical mechanism. In still another embodiment, the camera can have any of a variety of settings or ocular mechanisms that operate in conjunction with the one or more lights. There are numerous configurations that can be used to connect an optical mechanism 400 to a display device 430 outside the body, and embodiments of the subject invention are not limited to the few examples provided here. Other variations that provide the same functionality are within the scope of this invention.

In another embodiment, a grasper 600 can be utilized to move objects or material closer to the access port 320 working lumen 110 for suctioning. In one embodiment, a grasper can be inserted through the working lumen to pull objects through the working lumen or nearer to the access port. When a vacuum force is pulled on the working lumen, the objects can then be more easily suctioned. Alternatively, there can be an accessory lumen 120 that can be coaxial with the shaft through which a grasper can be forwarded into the body area or body cavity. Figure 4 illustrates an example of this embodiment. Several types of graspers are known in the art, including baskets, jaws, finger, or wire tripods, etc. that can be utilized with an accessory lumen 120. In an alternative embodiment, the grasper can be fixedly connected within the accessory lumen, such that it is not removable from the lumen. In a further embodiment, the grasper can be pulled into the accessory lumen sufficiently to conceal or protect it during the procedure of inserting the sheath into the body. Once the working tip is placed in vivo, the grasper can be pushed out of the accessory lumen for use. Prior to extraction of the sheath from the body, the grasper can be drawn back into the accessory lumen.

Endoscopes can be useful for conducting procedures in vivo. Specialized endoscopes for removing kidney stones, called cystoscopes or nephroscopes, have suction and visualization capabilities that make them useful for kidney stone removal. However, they often have a smaller diameter that limits the size of kidney stones that can be removed, which can mean additional or longer procedures for a patient. Sheaths are often used to protect the endoscopes and can have features of their own that aid in conducting in vivo procedures. Currently, related art sheaths do not include some of the same capabilities as an endoscope. The embodiments of the subject invention provide endoscope sheaths that have the combined capabilities of most endoscopes and sheaths that are necessary for most endoscopic procedures. By utilizing a working channel, capable of being used for suctioning, in addition to both a light and a camera, as well as an irrigation lumen, it is possible for an endoscope to be removed from the sheath without loss of the functions or capabilities of the endoscope. When combined with mechanisms in the sheath and deflector controls that allow the end of the sheath to be bent, turned, or manipulated within the body, a sheath of embodiments of the subject invention can be used for the same or more procedures than most endoscopes are currently capable of performing alone.

Embodiments of the subject invention include, but are not limited to, the following exemplified embodiments.

Embodiment 1. An endoscope sheath for in vivo kidney stone removal from a patient, the sheath comprising:

a bendable shaft having a distal end and a proximal end, the bendable shaft comprising a working tip at the distal end, at least one operational control at the proximal end, and a first working lumen within the shaft and coaxial therewith.

Embodiment 2. The endoscope sheath according to embodiment 1, further comprising a light in the working tip. Embodiment 3. The endoscope sheath according to any of embodiments 1-2, further comprising an image capturing mechanism in the working tip.

Embodiment 4. The endoscope sheath according to any of embodiments 1-3, further comprising an irrigation lumen at least partially coaxial with the shaft, the irrigation lumen opening at the working tip.

Embodiment 5. The endoscope sheath according to any of embodiments 1-4, wherein the shaft comprises a plurality of operational controls at the proximal end. Embodiment 6. The endoscope sheath according to any of embodiments 1-5, wherein the first working lumen is capable of applying suction through the working tip. Embodiment 7. The endoscope sheath according to any of embodiments 1-6, wherein the working tip is configured to be manipulated in vivo.

Embodiment 8. The endoscope sheath according to any of embodiments 3-7, wherein the image capturing mechanism is in operable communication with a display device capable of displaying images captured by the image capturing mechanism.

Embodiment 9. The endoscope sheath according to any of embodiments 3-8, further comprising a transmitter at the proximal end of the shaft, the transmitter being in operable communication with the image capturing mechanism.

Embodiment 10. The endoscope sheath according to embodiment 9, wherein the transmitter is in operable communication with a display device capable of displaying images captured by the image capturing mechanism.

Embodiment 11. The endoscope sheath according to any of embodiments 1-10, further comprising a screen at the working tip for limiting the size of kidney stones taken into the first working lumen. Embodiment 12. The endoscope sheath according to embodiment 11, wherein the screen covers the working tip comprises a plurality of pores.

Embodiment 13. The endoscope sheath according to any of embodiments 1-12 wherein the plurality of operational controls at the proximal end of the shaft comprises at least one of: a deflector control for manipulating the working tip; an image capturing control in operable communication with the image capturing mechanism; a light control in operable communication with the light; a vacuum control; and an irrigation control in operable communication with the irrigation lumen. Embodiment 14. The endoscope sheath according to any of embodiments 1-13, wherein the plurality of operational controls at the proximal end of the shaft comprises: a deflector control for manipulating the working tip; an image capturing control in operable communication with the image capturing mechanism; and

a light control in operable communication with the light; and

an irrigation control and an irrigation port both in operable communication with the irrigation lumen, the irrigation control comprising a valve control mechanism, and the irrigation port configured to be connected to a fluid source.

Embodiment 15. The endoscope sheath according to any of embodiments 1-14, further comprising:

a vacuum connector in operable communication with the first working lumen and configured to be connected to a vacuum source; and

a vacuum regulator in operable communication with the vacuum connector for regulating vacuum applied through the first working lumen. Embodiment 16. The endoscope sheath according to any of embodiments 1-15, wherein the bendable shaft further comprises an entryway formed through an outer surface thereof and opening into the first working lumen.

Embodiment 17. The endoscope sheath according to embodiment 16, wherein the entryway is located on the outer surface of the shaft between the proximal end of the shaft and a center point of the shaft, the center point being a point that is midway between the proximal end and the distal end.

Embodiment 18. The endoscope sheath according to any of embodiments 1-17, wherein the bendable shaft further comprises a second working lumen within the shaft and coaxial therewith.

Embodiment 19. The endoscope sheath according to any of embodiments 1-18, wherein the bendable shaft further comprises a third working lumen within the shaft and coaxi al therewith . Embodiment 20. The endoscope sheath according to any of embodiments 1-19, wherein the bendable shaft comprises a plurality of working lumens, the plurality of working lumens comprising the first working lumen, and

wherein the endoscope sheath further comprises a grasper at the working tip and inserted through at least a portion of a working lumen of the plurality of working lumens.

Embodiment 21. The endoscope sheath according to any of embodiments 1-20, wherein the plurality of operational controls at the proximal end of the shaft comprises a deflector control for manipulating the working tip,

wherein the deflector control is configured to manipulate the working tip such that the distal end of the shaft is capable of bending at an angle of 90° relative to a center point of the shaft, the center point being a point that is midway between the proximal end and the distal end. Embodiment 22. A method of removing at least one kidney stone in vivo from a patient, the method comprising:

providing the endoscope sheath according to any of embodiments 1-21;

capturing the at least one kidney stone by controlling, with the plurality of operational controls, the working tip; and

removing the at least one kidney stone with the endoscope sheath after capturing the kidney stone.

Embodiment 23. The method according to embodiment 22, wherein the endoscope sheath further comprises:

a vacuum regulator in operable communication with the vacuum connector for regulating vacuum applied through the first working lumen, and

wherein capturing the at least one kidney stone comprises:

connecting the vacuum connector to a vacuum source;

using the vacuum regulator to apply vacuum at the working tip through the first working lumen; and suctioning the at least one kidney stone into the first working lumen with the vacuum applied at the working tip.

Embodiment 24. The method according to any of embodiments 22-23, wherein the bendable shaft of the endoscope sheath comprises a plurality of working lumens, the plurality of working lumens comprising the first working lumen,

wherein the endoscope sheath further comprises a grasper at the working tip and inserted through at least a portion of a working lumen of the plurality of working lumens, and

wherein capturing the at least one kidney stone (further) comprises using the grasper to grasp the at least one kidney stone.

Embodiment 25. The endoscope sheath according to any of embodiments 1- 21 or the method according to any of embodiments 22-24, wherein the outer diameter of the endoscope sheath is larger than a working lumen of a typical (related art) endoscope.

Embodiment 26. The endoscope sheath according to any of embodiments 1- 21 or 25, or the method according to any of embodiments 22-25, wherein the outer diameter of the endoscope sheath is at least 0.8 millimeters (mm).

Embodiment 27. The endoscope sheath according to any of embodiments 1- 21 or 25, or the method according to any of embodiments 22-25, wherein the outer diameter of the endoscope sheath is at least 1.2 mm. Embodiment 28. The endoscope sheath according to any of embodiments 1-

21 or 25, or the method according to any of embodiments 22-25, wherein the outer diameter of the endoscope sheath is at least 3.0 mm.

Any reference in this specification to "one embodiment," "an embodiment," "example embodiment," "further embodiment," "alternative embodiment," etc., is for literary convenience. The implication is that any particular feature, structure, or characteristic described in connection with such an embodiment is included in at least one embodiment of the invention. The appearance of such phrases in various places in the specification does not necessarily refer to the same embodiment. In addition, any elements or limitations of any embodiments disclosed herein can be combined with any and/or all other elements or limitations (individually or in any combination) or any other invention or embodiment thereof disclosed herein, and all such combinations are contemplated with the scope of embodiments of the invention without limitation thereto.

It should be understood that the examples and embodiments described herein are for illustrative purposes only and that various modifications or changes in light thereof will be suggested to persons skilled in the art and are to be included within the spirit and purview of this application.

All patents, patent applications, provisional applications, and publications referred to or cited herein are incorporated by reference in their entirety, including all figures and tables, to the extent they are not inconsistent with the explicit teachings of this specification.

Claims

CLAIMS What is claimed is:

1. An endoscope sheath for in vivo kidney stone removal from a patient, the sheath comprising:

a bendable shaft having a distal end and a proximal end, the bendable shaft comprising a working tip at the distal end, a plurality of operational controls at the proximal end, and a first working lumen within the shaft and coaxial therewith, wherein the first working lumen is capable of applying suction through the working tip, wherein the working tip is configured to be manipulated in vivo;

a light in the working tip;

an image capturing mechanism in the working tip; and

an irrigation lumen at least partially coaxial with the shaft, the irrigation lumen opening at the working tip.

2. The endoscope sheath according to claim 1, wherein the image capturing mechanism is in operable communication with a display device capable of displaying images captured by the image capturing mechanism.

3. The endoscope sheath according to claim 1, further comprising a transmitter at the proximal end of the shaft, the transmitter being in operable communication with the image capturing mechanism.

4. The endoscope sheath according to claim 3, wherein the transmitter is in operable communication with a display device capable of displaying images captured by the image capturing mechanism.

5. The endoscope sheath according to claim 1, further comprising a screen at the working tip for limiting the size of kidney stones taken into the first working lumen.

6. The endoscope sheath according to claim 5, wherein the screen covers the working tip comprises a plurality of pores.

7. The endoscope sheath according to claim 1, wherein the plurality of operational controls at the proximal end of the shaft comprises at least one of: a deflector control for manipulating the working tip; an image capturing control in operable communication with the image capturing mechanism; a light control in operable communication with the light; a vacuum control; and an irrigation control in operable communication with the irrigation lumen.

8. The endoscope sheath according to claim 1, wherein the plurality of operational controls at the proximal end of the shaft comprises:

a deflector control for manipulating the working tip;

an image capturing control in operable communication with the image capturing mechanism; and

a light control in operable communication with the light; and

9. The endoscope sheath according to claim 8, further comprising:

a vacuum regulator in operable communication with the vacuum connector for regulating vacuum applied through the first working lumen.

10. The endoscope sheath according to claim 1, further comprising:

11. The endoscope sheath according to claim 1, wherein the bendable shaft further comprises an entry way formed through an outer surface thereof and opening into the first working lumen.

12. The endoscope sheath according to claim 11, wherein the entryway is located on the outer surface of the shaft between the proximal end of the shaft and a center point of the shaft, the center point being a point that is midway between the proximal end and the distal end.

13. The endoscope sheath according to claim 1, wherein the bendable shaft further comprises a second working lumen within the shaft and coaxial therewith.

14. The endoscope sheath according to claim 13, wherein the bendable shaft further comprises a third working lumen within the shaft and coaxial therewith.

15. The endoscope sheath according to claim 1, wherein the bendable shaft comprises a plurality of working lumens, the plurality of working lumens comprising the first working lumen, and

16. The endoscope sheath according to claim 1, wherein the plurality of operational controls at the proximal end of the shaft comprises a deflector control for manipulating the working tip,

wherein the deflector control is configured to manipulate the working tip such that the distal end of the shaft is capable of bending at an angle of 90° relative to a center point of the shaft, the center point being a point that is midway between the proximal end and the distal end.

17. A method of removing a kidney stone in vivo from a patient, the method comprising: providing the endoscope sheath according to claim 1;

capturing the kidney stone by controlling, with the plurality of operational controls, the working tip; and

removing the kidney stone with the endoscope sheath after capturing the kidney stone.

18. The method according to claim 17, wherein the endoscope sheath further comprises:

wherein capturing the kidney stone comprises:

connecting the vacuum connector to a vacuum source;

using the vacuum regulator to apply vacuum at the working tip through the first working lumen; and

suctioning the kidney stone into the first working lumen with the vacuum applied at the working tip.

19. The method according to claim 18, wherein the bendable shaft of the endoscope sheath comprises a plurality of working lumens, the plurality of working lumens comprising the first working lumen,

wherein the endoscope sheath further comprises a grasper at the working tip and inserted through at least a portion of a working lumen of the plurality of working lumens, and wherein capturing the kidney stone comprises using the grasper to grasp the kidney stone.

20. An endoscope sheath for in vivo kidney stone removal from a patient, the sheath comprising:

a bendable shaft having a distal end and a proximal end, the bendable shaft comprising a working tip at the distal end, a plurality of operational controls at the proximal end, and plurality of working lumens within the shaft and coaxial therewith, wherein the plurality of working lumens comprises a first working lumen that is capable of applying suction through the working tip, wherein the working tip is configured to be manipulated in vivo;

a light in the working tip;

an image capturing mechanism in the working tip; and

an irrigation lumen at least partially coaxial with the shaft, the irrigation lumen opening at the working tip; and

a transmitter at the proximal end of the shaft, the transmitter being in operable communication with the image capturing mechanism and with a display device capable of displaying images captured by the image capturing mechanism,

wherein the plurality of operational controls at the proximal end of the shaft comprises:

a deflector control for manipulating the working tip;

a light control in operable communication with the light;

an irrigation control and an irrigation port both in operable communication with the irrigation lumen, the irrigation control comprising a valve control mechanism, and the irrigation port configured to be connected to a fluid source; and a vacuum control and a vacuum connector both in operable communication with the first working lumen, the vacuum control being a vacuum regulator in operable communication with the vacuum connector for regulating vacuum applied through the first working lumen, and the vacuum connector being configured to be connected to a vacuum source,

wherein the bendable shaft further comprises an entryway formed through an outer surface thereof and opening into the first working lumen,

wherein the entryway is located on the outer surface of the shaft between the proximal end of the shaft and a center point of the shaft, the center point being a point that is midway between the proximal end and the distal end, and wherein the deflector control is configured to manipulate the working tip such that the distal end of the shaft is capable of bending at an angle of 90° relative to the center point of the shaft.