Insertion device with distal chamber

Abstract

A system includes a speculum device, an adapter, and a sheath. The device includes a sight glass cap and a shaft extending longitudinally from a proximal end to a distal end. The shaft includes a working passage. The cap is coupled to the distal end such that the inlet opening of the cap communicates with and is aligned with the passageway. The adapter has a generally tubular body mountable on the cap such that a distal chamber defined via the adapter and the cap opens into and communicates with the opening of the cap such that when negative pressure is applied through the passageway, a suction force is applied through the distal chamber to attract calculi from the region into or against the chamber. The sheath delivers fluid to the region via a space extending between an interior of the sheath and an exterior of the shaft.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims the priority of U.S. Provisional Application No. 63 / 381,242, filed on October 27, 2022, the entire content of which is incorporated herein by reference. Background Art

[0003] Insertion devices, including endoscope devices, can be used in combination with energy devices and / or retrieval devices to remove foreign objects or debris from the human body, such as stones, stone fragments, or tissue. For example, ureteroscopes (such as LithoVue TM flexible ureteroscopes) are often used to treat kidney stones and ureteral stones. Ureteroscopes are typically used in combination with devices such as guidewires, retrieval devices, and laser fibers. For example, urologists typically use ureteroscopes in combination with laser fibers for shattering kidney stones and baskets for retrieving and / or removing debris from the body.

[0004] According to another example using fragmentation techniques, urologists can use low - pulse, high - frequency laser energy from a more powerful laser system to shatter stones into extremely fine fragments so that the fragments can remain in the kidney (to pass spontaneously through urine) or be removed from the body via aspiration. However, stone powder in the lower pole is likely not to pass spontaneously or through. Therefore, urologists will migrate lower - pole stones to the upper pole before fragmentation.

[0005] However, techniques using insertion devices such as ureteroscopes can be time - consuming and may require multiple endoscopic maneuvers / deflections to break and capture stones for removal. For example, stone fragments may require additional time and effort to locate, capture, and remove because stone fragments smaller than 3 mm may be difficult to enter the basket, capture, and remove. Additionally, for each stone removal, the basket and endoscope must be removed from the body. In some cases, large stones of incorrect size judgment may wedge or get stuck in the ureter or near the sheath. In other cases, kidney stones broken distally to the endoscope may disperse the powder throughout the kidney. Additionally, lasers typically have a push - back effect where the laser energy pushes the stone away from the laser, thus requiring frequent re - positioning of the laser so that the laser can contact the stone for optimal fragmentation. However, fast lasers may cause overheating of adjacent fluids, thereby burning / browning the surrounding tissue. Summary of the Invention

[0006] The present disclosure relates to a system for treating stones in a hollow organ or body passage. The system includes an endoscope device that includes an endoscope cap and a shaft that longitudinally extends from a proximal end to a distal end. The shaft is configured to be inserted into a target area within the hollow organ or body passage and includes a working passage extending therethrough. The endoscope cap is coupled to the distal end of the shaft such that an inlet opening of the endoscope cap is in communication with and aligned with the working passage.

[0007] In addition, the system includes an adapter having a generally tubular body that is mountable on the endoscope cap such that a distal chamber defined by the adapter and the endoscope cap leads to and is in communication with the inlet opening of the endoscope cap, so that when negative pressure is applied through the working passage, suction is applied through the distal chamber to attract a target stone from the target area into or against the distal chamber. Further, the system includes an outer sheath that longitudinally extends from a proximal end to a distal end, and the outer sheath is configured to be slidable along the length of the shaft. The outer sheath is configured to deliver fluid to the target area via a space extending between an interior of the outer sheath and an exterior of the shaft.

[0008] In an embodiment, the outer sheath is configured to deliver fluid to the target area via its distal end to provide a continuous fluid circulation from the distal end of the outer sheath proximally through the distal chamber and the working passage.

[0009] In an embodiment, the distal end of the outer sheath is configured to enclose the shaft, and the outer sheath includes an outlet opening extending through a wall adjacent to its distal end for providing fluid to the target area.

[0010] In an embodiment, the distal end of the outer sheath includes an elastic band.

[0011] In an embodiment, a proximal portion of the adapter is configured to be mounted on the endoscope cap via a friction fit.

[0012] In an embodiment, the adapter and the outer sheath are integrally formed.

[0013] In an embodiment, the system further includes a laser fiber configured to be inserted through the working passage and the inlet opening into the distal chamber to treat a stone aspirated into or against the distal chamber.

[0014] In addition, the present disclosure relates to a system for treating stones in a hollow organ or body passage. The system includes an endoscope cap and an endoscope device that includes a shaft that longitudinally extends from a proximal end to a distal end. The shaft is configured to be inserted into a target area within the hollow organ or body passage and includes a first working passage and a second working passage extending therethrough. The endoscope cap is coupled to the distal end of the shaft such that an inlet opening of the endoscope cap is in communication with and aligned with the first working passage.

[0015] The system further includes an adapter that extends from a proximal end to a distal end and includes a lumen extending therethrough. The proximal portion of the adapter is configured to be mounted on the endoscope cap such that the distal portion of the adapter and the endoscope cap define a distal chamber therebetween, such that when negative pressure is applied through the first working passage, the suction force applied through the distal chamber attracts the target knot into or against the distal chamber.

[0016] In an embodiment, the shaft of the endoscope device includes an exit opening extending through its wall, the exit opening being positioned near the distal end of the shaft and in communication with the second working passage of the endoscope device to provide fluid to the target area.

[0017] In an embodiment, the proximal portion of the adapter is configured to engage the endoscope cap via a friction fit.

[0018] In an embodiment, the proximal portion of the adapter includes an elastic connector configured to fit the proximal portion around the endoscope cap.

[0019] In an embodiment, the second working passage of the endoscope device is in communication with and aligned within an exit opening extending through the endoscope cap.

[0020] In an embodiment, the distal portion of the adapter has a smaller cross-section than the proximal portion of the adapter, the distal portion of the adapter extending from the proximal portion of the adapter such that the distal chamber is in communication with the inlet opening and is longitudinally offset from the longitudinal axis along which it extends through the endoscope cap from the exit opening, such that fluid passing through the exit opening is delivered to a target area external to the distal chamber.

[0021] In an embodiment, the distal portion includes a longitudinal recess extending along its outer surface, the longitudinal recess being aligned with the longitudinal axis of the exit opening.

[0022] In an embodiment, the adapter has a generally tubular body, the proximal portion of the adapter including an exit opening extending through its wall such that when the adapter is mounted on the endoscope cap, the exit opening of the adapter is aligned with the exit opening of the endoscope cap, the exit opening of the endoscope cap extending laterally through the side wall of the endoscope cap.

[0023] In addition, the present disclosure relates to a method for treating ureteral stones or kidney stones. The method includes mounting a tubular adapter on the endoscope cap of an endoscope device such that a distal portion of the adapter and the endoscope cap define a distal chamber therebetween, wherein the endoscope cap is coupled to a distal end of a shaft that includes a working passage longitudinally extending therethrough such that an inlet opening of the endoscope cap is longitudinally aligned with the working passage of the shaft; sliding an outer sheath along the length of the shaft of the endoscope device such that a distal end of the outer sheath is proximal to the distal end of the shaft of the endoscope device; inserting the endoscope device with the adapter and the outer sheath assembled therewith into a target area within a patient; supplying fluid to the target area via a space between an inner surface of the outer sheath and an outer surface of the shaft; applying negative pressure through the working passage to aspirate a target stone into or against the distal chamber; and performing laser treatment on the target stone such that stone particles and heat generated by the laser treatment are aspirated proximally and discharged from the patient's body via a continuous fluid circulation through the inlet opening.

[0024] In an embodiment, laser energy is provided via a laser fiber inserted distally through the working passage and the inlet opening such that stone particles and fluid are aspirated from the target area via a space between an outer portion of the laser fiber and an inner portion of the working passage.

[0025] In an embodiment, supplying fluid to the target area and aspirating fluid from within the patient includes managing a continuous fluid circulation to control pressure generated within the target area due to flushing or migrating one or both of the target stone and stone particles.

[0026] In an embodiment, the distal end of the outer sheath is assembled around the shaft and fluid is supplied to the target area via an outlet opening extending through a wall of the outer sheath, the outlet opening being located along a portion of the wall immediately proximal to the distal end of the outer sheath.

[0027] In an embodiment, the adapter and the outer sheath are integrally formed and a proximal portion of the adapter is assembled around the endoscope cap. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Figure 1 A longitudinal side view of a distal portion of a system according to an exemplary embodiment of the present disclosure is shown;

[0029] Figure 2 Shown according to Figure 1 is a longitudinal side view of an endoscope device of the system;

[0030] Figure 3 Shown according to Figure 1 is an enlarged view of a portion of a handle member of an endoscope device of the system;

[0031] Figure 4 Shown in a deflected configurationFigure 1 Longitudinal side view of an endoscope device of a system;

[0032] Figure 5 Shows according to Figure 1 Perspective view of an adapter of a system;

[0033] Figure 6 Shows Figure 5 Plan view of an adapter;

[0034] Figure 7 Shows according to Figure 1 Perspective view of the distal portion of a system;

[0035] Figure 8 Shows Figure 1 Longitudinal side view of the distal portion of a system;

[0036] Figure 9 Perspective view of an adapter according to another exemplary embodiment of the present disclosure;

[0037] Figure 10 Shows Figure 9 Plan view of an adapter;

[0038] Figure 11 Shows Figure 9 Cross-sectional view of the distal portion of an adapter;

[0039] Figure 12 Perspective view of an adapter in an unassembled configuration according to yet another exemplary embodiment of the present disclosure;

[0040] Figure 13 Shows according to Figure 12 Longitudinal side view of an adapter in an unassembled configuration;

[0041] Figure 14 Shows according to Figure 12 Longitudinal side view of an adapter in an assembled configuration;

[0042] Figure 15 Perspective view of the distal portion of a system according to another exemplary embodiment of the present disclosure;

[0043] Figure 16 Shows according to Figure 15 Plan view of an adapter of an exemplary system;

[0044] Figure 17 Shows Figure 15 Longitudinal side view of the distal portion of a system;

[0045] Figure 18 Cross-sectional view of the inlet passage of an adapter according to an alternative embodiment of the present disclosure;

[0046] Figure 19 Shows a cross-sectional view of the inlet passage of an adapter according to yet another alternative embodiment of the present disclosure;

[0047] Figure 20 Shows a perspective view of the distal portion of a system according to another exemplary embodiment of the present disclosure;

[0048] Figure 21 Shows according to Figure 20 A plan view of an adapter of an exemplary system;

[0049] Figure 22 Shows a perspective view of the distal portion of a system according to yet another exemplary embodiment of the present disclosure;

[0050] Figure 23 Shows according to Figure 22 A perspective view of a doorway adapter of an exemplary system;

[0051] Figure 24 Shows a longitudinal side view of the distal portion of a system according to another exemplary embodiment of the present disclosure;

[0052] Figure 25 Shows a longitudinal side view of the distal portion of a system according to yet another exemplary embodiment of the present disclosure;

[0053] Figure 26 Shows a perspective view of the distal portion of a system according to another exemplary embodiment of the present disclosure;

[0054] Figure 27 Shows a perspective view of the distal portion of a system in an unassembled configuration according to another exemplary embodiment of the present disclosure;

[0055] Figure 28 Shows the distal portion of a Figure 27 system in an assembled configuration;

[0056] Figure 29 Shows a perspective view of the distal portion of a system in an unassembled configuration according to another exemplary embodiment of the present disclosure;

[0057] Figure 30 Shows the distal portion of a Figure 29 system in an assembled configuration;

[0058] Figure 31 Shows a perspective view of the distal portion of a system in an unassembled configuration according to yet another exemplary embodiment of the present disclosure;

[0059] Figure 32 Shows the distal portion of aFigure 31 Perspective view of the distal portion of the system;

[0060] Figure 33 Perspective view of the distal portion of the system in an unassembled configuration, showing another exemplary embodiment according to the present disclosure; and

[0061] Figure 34 Showing in an assembled configuration Figure 33 Perspective view of the distal portion of the system. Detailed Description

[0062] The present disclosure can be further understood with reference to the following description and drawings, in which like elements are denoted by like reference numerals. The present disclosure relates to systems and methods for accessing, examining, and / or treating hollow organs, body passages, or body cavities, and in particular, can relate to systems and methods for performing ureteroscopy, and more particularly, to the treatment of kidney stones.

[0063] An exemplary embodiment describes a system that includes a ureteroscope that can be used to treat ureteral stones and / or kidney stones, and an adapter that can be mounted to the distal end of the shaft of the ureteroscope. The exemplary adapter is configured to provide an outlet and an inlet path through which fluid can be provided to a target area and negative pressure can be applied via the inlet path, thereby providing a continuous fluid circulation to transport debris, particles, and / or detritus, along with any generated heat and / or pressure, out of the body and away from the target area.

[0064] In addition, the adapter includes a distal chamber for receiving or otherwise confining a stone or stone fragment to be captured and / or to be laser treated. It should be noted that although the exemplary embodiment shows and describes a system and method including a ureteroscope, those skilled in the art should understand that the systems and methods of the present disclosure can include any of a variety of other insertion devices that can similarly be used in combination with other energy devices and / or retrieval devices and for other areas of the body. It should also be noted that the terms "proximal" and "distal" as used herein refer to directions toward (proximal) and away from (distal) the user (e.g., a doctor) of the device.

[0065] As Figures 1 - 8As shown, a system 100 for treating a hollow organ or cavity according to an exemplary embodiment of the present disclosure includes an endoscope device 102 (e.g., a ureteroscope), the endoscope device including a shaft 104 configured to be inserted through a body cavity into a target area (e.g., the ureter, kidney accessible via a natural body orifice) and an adapter 106 permanently mounted on the distal end 108 of the shaft 104 of the endoscope device 102 such that each of a plurality of passageways or openings extending through a portion of the adapter 106 is in fluid communication and / or alignment with a corresponding portion of the endoscope device 102. The shaft 104 can be a flexible shaft.

[0066] Specifically, the adapter 106 includes an outlet 110 and an inlet passage 112 through which fluid passing through the shaft 104 can be provided to the target area, and a negative pressure applied through the shaft 104 can be provided to the target area via the inlet passage. The fluid provided through the outlet 110 and the negative pressure applied via the inlet passage 112 together provide a continuous fluid circulation through the target area along path A, as Figure 1 shown, such that stone fragments, particles, and / or debris, along with any heated fluid (heated via laser treatment or other treatment of the stone), can be removed from the target area. Accordingly, the adapter 106 can further include a laser passage 114 through which a laser fiber 120 of a working passage passing through the shaft 104 can be received to perform laser treatment on the stone or stone fragments. The adapter 106 further includes a distal chamber 116 that opens to the exterior of the adapter 106 at its distal end 146 for receiving the stone or stone fragments therein and / or against it during removal, transportation, and / or laser treatment of the stone. In an exemplary embodiment, the fluid management system of the endoscope device 102 can be used to control the fluid supplied to and / or removed from the target area to manage, for example, the intrarenal pressure caused by flushing and / or transportation of the stone or stone fragments.

[0067] As Figures 1 - 4 shown, the endoscope device 102 can include any one of a variety of endoscope devices, the variety of endoscope devices including, for example, a ureteroscope (such as LithoVue TM or LithoVue TM Elite). As Figure 2 and Figure 4 shown, the endoscope device 102 includes a shaft 104 that extends along a longitudinal axis from a proximal end 122 held outside the body to a distal end 108 inserted into a target site within the body. The shaft 104 is configured to be inserted through a body cavity into the target site to be treated (e.g., within the kidney or ureter), for example, via a natural body orifice or a surgical opening. Figure 1 The distal end 108 of the illustrated embodiment includes a mounting bracket 138 that facilitates a sealed engagement of the distal end 108 with the adapter 106.

[0068] In one embodiment, the mounting bracket 138 includes a laterally extending protrusion 140 configured to engage an alignment slot 142 formed in the adapter 106, which will be described in further detail below. The endoscope device 102 additionally includes an imaging system 118 that facilitates navigating the distal end 108 of the shaft 104 to a target area and for visualization of the target area to guide treatment and the like, as will be understood by those skilled in the art. In one example, the imaging system 118 may include an imager and an LED. In this embodiment, the imager and the LED are shown as separate components. Those skilled in the art will understand that the imaging system may include any of a variety of imaging components and, in some embodiments, may include a combined imager and LED.

[0069] The shaft 104 includes one or more working passages, each of which may be accessed via one or more interfaces 126 of a handle member 124 attached to the proximal end 122 of the shaft 104. According to Figure 3 the exemplary embodiment shown, the shaft 104 includes three working passages and the handle member 124 includes three interfaces: a first interface 126A, a second interface 126B, and a third interface 126C, each of which accesses a corresponding one of the working passages. According to the exemplary embodiment, for example, a first working passage for delivering fluid to the target area may be accessed via the first interface 126A, while a second working passage for applying negative pressure to the distal end of the shaft 104 is accessed via the second interface 126B, and in this embodiment the third passage that houses the laser fiber 120 is accessed via the third interface 126C.

[0070] In this embodiment, the second interface 126B (for accessing the second working passage through which negative pressure is applied) may be fitted with a three-way stopcock 128 that facilitates flushing the corresponding working passage and the inlet passage 112 of the adapter 106, the inlet passage of the adapter being in fluid communication and / or alignment with the corresponding working passage. In this embodiment, a first port 130 of the stopcock 128 is connected to a fluid source for flushing the working passage, while a second port 132 of the stopcock 128 is connected to a suction source. Thus, the second working passage (and the inlet passage 112 connected thereto) may be flushed by rotating the stopcock knob 134 to open the first port 130 while closing the second port 132.

[0071] The stopcock knob 134 can be rotated again to close the first port 130 so that suction can be applied through the second port 132. Flushing can be used to remove blockages, clean the imager lens, and / or increase the fluid flow during suction. As will be understood by those skilled in the art, further rotation of the stopcock knob 134 can close both ports (i.e., the first port 130 and the second port 132).

[0072] Although the exemplary embodiment shows and describes the shaft 104 of the endoscope device 102 including three working channels, those skilled in the art will understand that this is not necessary. In some embodiments, a single working channel can serve more than one purpose. For example, the laser fiber 120 can be inserted via the same working channel through which negative pressure is applied. In this case, the interface 126 corresponding to this working channel can include a Y-connector, where the negative pressure source is coupled to the first arm of the Y-connector, and the laser fiber 120 can be inserted through the second arm of the Y-connector. If flushing of the working channel is required, a three-way stopcock can be connected to one arm of the Y-connector while the other arm of the Y-connector is sealed via a valve (such as UroLok TM or Tuohy Borst).

[0073] According to an exemplary embodiment, the handle member 124 can further include a deflection knob 136 for deflecting the distal end 108 into, for example, a pigtail configuration, as Figure 4 shown. In one embodiment, the shaft 104 can be configured to deflect bidirectionally up to approximately 270 degrees in either direction to facilitate navigation to, for example, the poles of the kidney. Those skilled in the art will understand that the adapter 106 is attached to the distal end 108 of the shaft 104 such that deflection of the distal end 108 correspondingly deflects the adapter 106 so that the adapter can be pointed in a desired orientation relative to the target area. Those skilled in the art will also understand that the above deflection is merely exemplary, and in some embodiments, the endoscope device 102 can include a rigid shaft instead of the shaft 104 shown and described herein, or a shaft including rigid and flexible portions in any desired arrangement.

[0074] According to an exemplary embodiment, as Figures 5 - 6As shown, adapter 106 includes a tubular body 107 extending from a proximal end 144 to a distal end 146 and includes a lumen 152 therethrough. Adapter 106 includes a proximal portion 148 and a distal portion 150. The proximal portion is configured to serve as an endoscope cap on the distal end 108 of the shaft 104 of the endoscope device 102. The distal portion includes a distal chamber 116. The proximal portion and the distal portion 148, 150 are separated from each other by a partition 154 extending across the lumen 152. The partition 154 and the wall 156 of the body 107 along the distal portion 150 define the distal chamber 116, in which a calculus or calculus fragments can be received and / or a calculus or calculus fragments can be aspirated against the distal chamber for laser treatment, which will be described in further detail below. The wall 156 along the distal portion 150 may include a tapered portion 166 that tapers towards the distal end 146 to facilitate insertion of the adapter 106 through a body orifice (such as a ureteral orifice).

[0075] The proximal portion 148 is configured to be sealingly mounted on a mounting bracket 138 at the distal end 108 of the shaft 104. In one embodiment, the proximal portion 148 may include an alignment slot 142 extending longitudinally from the proximal end 144 through the wall 156 of the adapter 106. The alignment slot 142 is sized and shaped to correspond to a protrusion 140 of the mounting bracket 138 such that when the protrusion 140 is received and engaged within the alignment slot 142, the adapter 106 is in a desired alignment relative to the shaft 104.

[0076] Specifically, as will be described in further detail below, when the adapter 106 is in a desired alignment with the shaft 104, the inlet passage 112 will be aligned with the working passage through which negative pressure (i.e., suction force) is applied, and the laser passage 114 will be aligned with the working passage through which the laser fiber 120 is inserted. In addition, components of the imaging system 118 (such as an imager and an LED) will be properly aligned with corresponding passages / openings of the adapter 106.

[0077] According to an exemplary embodiment, the outlet 110 includes a plurality of holes 111, each hole 111 extending through a portion of the wall 156 along the proximal portion 148 of the adapter 106 such that the lumen 152 leads to the outside of the adapter 106 via the holes 111. The holes 111 are located between the proximal end 144 and the partition 154 that sealingly engages the distal end 108 of the shaft 104 (such as the mounting bracket 138). The adapter 106 is coupled to the shaft 104, so that fluid supplied through, for example, the first interface 126A flows through the first working passage along the proximal portion 148 of the adapter 106 into the lumen 152 and out of the holes 111 of the outlet 110.

[0078] In an exemplary embodiment, the holes 111 are positioned around the perimeter (e.g., circumference) of the proximal portion 148 such that when fluid is provided through a first working passageway, such as the shaft 104, the fluid is ejected circumferentially outwardly in pattern B, as Figure 6 shown, to hold stone fragments distal to the outlet 110 and prevent the fragments / particles from dispersing proximally. In one embodiment, the holes 111 are equidistantly spaced from each other around the circumference of the adapter 106. However, those skilled in the art will also understand that the holes 111 may extend through the wall 156 along the proximal portion 148 in any of a variety of configurations. Those skilled in the art will also understand that although the outlet 110 is described as including a plurality of holes 111 through the wall 156, in an alternative embodiment, the outlet 110 may extend into a single hole through the wall 156 in the proximal portion 148 of the adapter 106.

[0079] The inlet passageway 112 extends longitudinally along the proximal portion 148 through the lumen 152 from a distal opening 158 in the septum 154 to a proximal opening that is configured to align with and / or engage a second working passageway, such as the shaft 104, through which negative pressure is applied via the second interface 126B to provide suction. The inlet passageway 112 leads to the distal chamber 116 such that when suction is applied through the inlet passageway, fluid, stone fragments / particles, and / or debris are drawn into the distal chamber 116 and / or against a portion of the distal chamber. In one embodiment, the inlet passageway 112 may have a generally funnel-shaped configuration such that stone fragments / particles / debris leak into the second working passageway.

[0080] The laser passageway 114 also extends longitudinally along the proximal portion 148 through the lumen 152 from a distal opening 160 in the septum 154 to a proximal end that is configured to engage a third working passageway, such as the shaft 104. In this embodiment, the laser fiber 120 may pass through the third interface 126C and the shaft 104 such that the laser fiber 120 extends distally beyond the distal opening 160 to move into contact with or adjacent to a stone or stone fragment to be laser-treated. Although the laser passageway 114 is described and shown as a laser passageway, those skilled in the art will understand that the laser passageway 114 may be configured to receive other energy devices and / or retrieval devices.

[0081] In this embodiment, adapter 106 further includes an imager passageway 162 and an LED passageway 164 that extend through the proximal portion 148 for receiving corresponding components of the imaging system of the endoscope device 102. The imager passageway and / or the LED passageways 162, 164 can be configured as windows that extend through the separator 154. However, those skilled in the art will understand that the imager passageway 162 and the LED passageway 164 do not need to extend through the separator 154. However, the adapter 106, including the separator 154 and the distal portion 150, is formed of an optically transparent (e.g., translucent) material such that imaging is provided via the imaging system through the optically transparent material.

[0082] Those skilled in the art will also understand that although the adapter is shown as including two separate passageways 162, 164, the adapter 106 can include any number of passageways, openings, or windows for receiving components of the imaging system 118, depending on the configuration of the imaging system 118. For example, in some embodiments, the imaging system 118 can include a combined imager and LED such that the adapter 106 can include a single window / passageway for receiving the imaging system 118. Additionally, although not shown, those skilled in the art will understand that the adapter 106 can be configured to receive additional components of the endoscope device 102, such as a pressure sensor or other sensors. In an exemplary embodiment, a pressure sensor can be used to control the fluid management system of the endoscope device 102 to manage, for example, the interrenal pressure. The fluid management system can respond to the pressure reading by, for example, increasing or decreasing the flow from the outlet 110 and / or increasing or decreasing the negative pressure applied through the inlet passageway 112 to regulate the interrenal pressure. As understood by those skilled in the art, complications (e.g., fever, SIRS, sepsis, postoperative pain, prolonged hospital stay, and perinephric hematoma) can be caused by high renal pelvic pressure.

[0083] According to an exemplary method of using the system 100 to treat, for example, kidney stones, the shaft 104 of the endoscope device 102, including the adapter 106 mounted to its distal end 108, is inserted through a body orifice (e.g., the urethral orifice) or a surgically formed opening into the target area where the stone or stone fragment to be treated (hereinafter referred to as "stone 10") is located. When the distal end of the shaft 104 is positioned relative to the stone 10A as needed, suction can be applied through the shaft 104 via, for example, the second interface 126B such that the stone 10 is aspirated and / or abutted against the distal chamber 116, as Figures 7 - 8 shown. When the stone 10 is too large to be aspirated proximally into the distal chamber 116, the stone 10 will be pulled by suction against the distal end 146 of the adapter 106.

[0084] In one embodiment, when the stone 10 is held against the distal chamber 116 by aspiration, the shaft 104 can be moved to position the distal end 146 of the adapter 106 such that the stone 10 is at a desired location within the body where it is desired to crush and / or fragment the stone 10. For example, the stone 10 can be migrated from the lower pole of the kidney to the mid-pole to facilitate removal and extraction of debris from within the kidney.

[0085] To treat the stone 10, when the stone 10 is held within or against the distal chamber 116 by suction force, the laser fiber 120 can be moved distally through the shaft 104 (e.g., via the third interface 126C) such that the distal end 121 of the laser fiber 120 extends distally beyond the distal opening 160 of the laser passageway 114 to contact the stone 10 or be very close to the stone. In one embodiment, the laser fiber 120 can be used to fragment the stone 10 such that the fragmented portions of the stone 10 are received within the distal chamber 116 and are drawn into the distal chamber by negative pressure to be removed from the patient's body by withdrawing the endoscope device 102 from the patient's body. As will be understood by those skilled in the art, this ensures that the fragments of the stone 10 can be fragmented until they are small enough to pass through the ureter and / or through the access sheath used to access the target area.

[0086] In another embodiment, the laser fiber 120 can be used to pulverize the stone 10. As the stone 10 is fragmented into smaller pieces, the pieces can be received within the distal chamber 116, thereby allowing the stone / stone fragments to pulsate or move around within the distal chamber 116 by, for example, reducing the negative pressure, such that the laser randomly fires at the stone fragments to fragment them into a powder size that can be aspirated through the inlet passageway 112 and expelled from the patient's body.

[0087] When the laser fiber 120 laser-treats the stone / stone fragments, the negative pressure applied through the inlet passageway 112 confines the resulting powder particles 12 and heat within the distal chamber 116. As described above, when the stone 10 is laser-treated and negative pressure is applied, fluid is also supplied through the holes 111 of the outlet 110 to prevent the powder from dispersing proximally through the adapter 106. This also creates a (continuous if desired) fluid circulation from the outlet 110 into the body cavity and distally towards the distal end of the adapter 106, through which the fluid enters the distal chamber 116.

[0088] Powder / debris and heat are generated within and / or adjacent to the distal chamber 116. Thus, the fluid flowing proximally into the distal chamber 116 absorbs the heat generated by the laser treatment of the stone 10. The heat is then removed from the area via the heated fluid, which is suctioned into the inlet passage 112 and through which the heated fluid (along with powder and stone fragments) is discharged outside the patient. Since the generated powder particles 12 are suctioned out of the patient, the endoscope device 102 can remain in the target area for a longer time to treat the next stone / stone fragment, as described above, until all the stones / stone fragments have been treated and the patient is stone-free.

[0089] As Figures 9 - 11 shown, the adapter 206 according to another exemplary embodiment is a separate article configured to be coupled to the distal end of the endoscope device, which endoscope device may be similar to the endoscope device described above with respect to the system 100, in addition to the adapter 106. Similar to the adapter 106, the adapter 206 includes an outlet 210 and an inlet passage 212 for delivering fluid to the target area and through which a suction force may be applied to provide a continuous fluid flow along path B, as Figure 9 shown, distally along the exterior of the adapter 206 to the distal end of the adapter 206, at which the fluid flow is drawn into the adapter 206 via suction applied through the inlet passage 212. The adapter 206 also includes a laser passage 214 through which an energy device (such as a laser fiber) may pass in the same manner as in the system 100 described above.

[0090] Similar to the adapter 106, the inlet passage 212 and the laser passage 214 lead to and are in fluid communication with the distal chamber 216 of the adapter 206, within which stone fragments / particles / debris may be received or suctioned against such that the stone fragments may be treated (e.g., via laser) and suctioned from the target area through the inlet passage 212. However, the outlet 210 is also configured in this embodiment as a passage 211 that extends longitudinally through a portion of the adapter 206, rather than as a hole extending through the circumferential wall of the adapter as described above with respect to the adapter 106.

[0091] In particular, similar to adapter 106, adapter 206 extends longitudinally from a proximal end 244 to a distal end 246 and includes a lumen 252 extending therethrough. Adapter 206 includes a proximal portion 248 and a distal portion 250 that are separated from each other by a partition 254 extending across lumen 252. The proximal portion 248 is configured to be mounted on or otherwise coupled to the distal end of the endoscope device at the distal end of the endoscope device, while the distal portion 250 is configured to define a distal chamber 216 therein for receiving stone fragments, particles, and / or debris / powder in the distal chamber. Similar to adapter 106, an inlet passage 212 extends proximally from a distal opening 258 in the partition 254 through the proximal portion 248 to a proximal opening that is configured such that when adapter 206 is mounted on the distal end of the endoscope device or other insertion device, it engages a working passage of the endoscope device that is configured to receive negative pressure therethrough.

[0092] A laser passage 214 extends proximally from a distal opening 260 in the partition 254 through the proximal portion to a proximal opening that is configured to engage a working passage of the endoscope device through which an energy device (such as a laser fiber) of the endoscope device can pass. Thus, similar to adapter 106, inlet passage 212 and laser passage 214 are in fluid communication with and lead to distal chamber 216. Although laser passage 214 is described as a laser passage, those skilled in the art will understand that if desired, a laser fiber (or other energy device) can share inlet passage 212 such that laser passage 214 can be used to insert other tools into the target area. In an alternative embodiment, laser passage 214 can be completely eliminated.

[0093] In this embodiment, the outlet 210 is also configured as a passage 211 that extends longitudinally through lumen 252 from a distal opening 268 in the partition 254 through the proximal portion 248 to a proximal opening that is configured to engage a working passage of the endoscope device through which fluid of the endoscope device can be supplied. However, the outlet 210 does not lead to and / or is not in fluid communication with the distal chamber 216 defined within the distal portion 250 of adapter 206. The wall 256 of adapter 206 along the distal portion 250 includes a longitudinal recess 270 along the outer perimeter of the adapter that is aligned with passage 211 of outlet 210 such that fluid passing through passage 211 of outlet 210 is directly transmitted distally along the outer surface of adapter 206 to the target area. This fluid is supplied to the target area through outlet 210 and then is suctioned into adapter 206 via inlet passage 212 along path B through distal chamber 216.

[0094] Those skilled in the art will understand that the adapter 206 can be mounted on the endoscope device, removed from the endoscope device and / or otherwise coupled to the endoscope device and removed from the endoscope device in some way, thereby producing an endoscope device that operates in a manner similar to the system 100 described above, and can be used to treat stones / fragments and / or tissues in a manner substantially similar to the usage method of the above-described system 100. Those skilled in the art will also understand that although not specifically described, the adapter 206 can similarly include one or more passageways 262 for accommodating the components of the imaging system of the endoscope device in any manner and configuration required to accommodate the components of the endoscope device for which the adapter 206 is configured.

[0095] As Figures 12 - 14 shown, the adapter 306 according to another exemplary embodiment of the present disclosure is substantially similar to the adapter 106 described above, except as described below. In contrast to the adapter 106, as Figures 12 - 13 shown, the adapter 306 includes a proximal portion 348 and a distal portion 350 configured as two separate components, as Figure 14 shown, the proximal portion and the distal portion can be releasably assembled to each other via any of a variety of coupling mechanisms, including but not limited to friction fit, snap 349 and groove 351, and threads. The proximal portion and the distal portion 348, 350 can be substantially similar to the proximal portion and the distal portion of the adapter 106. However, the proximal portion 348 includes a distal face 354 instead of a bulkhead.

[0096] The inlet passage 312 extends longitudinally through the lumen 352 of the proximal portion 348 from a distal opening 358 that extends through the distal face 354 to a proximal end that is configured to engage a corresponding working passage of the endoscope device (e.g., a working passage through which negative pressure can be applied), as described above. Similarly, the laser passage 314 of this embodiment can extend longitudinally through the lumen 352 of the proximal portion 348 from a distal opening 360 that extends through the distal face 354 to a proximal end that is configured to engage a corresponding working passage of the endoscope device (e.g., a working passage through which an energy device can be inserted), as described above. Similar to the adapter 306, the outlet 310 can be configured as one or more holes 311 that extend through the wall 356 of the proximal portion 348.

[0097] The distal portion 350 of this embodiment is substantially similar to the distal portion 150 and includes features substantially similar thereto, such as the tapered surface 366 at its distal end to facilitate insertion through a body orifice. However, the distal portion 350 has a substantially tubular configuration, i.e., a lumen extends therethrough such that its proximal end is open. The distal chamber 316 is not formed until the distal portion 350 is assembled with the proximal portion 348. Once assembled, the distal face 354 of the proximal portion 348 acts similarly to the separator 154 described with respect to the adapter 106, which defines the proximal end of the distal chamber 316.

[0098] As Figures 15 - 17 shown, a system 400 according to another exemplary embodiment of the present disclosure is substantially similar to the above-described system 100, except for the differences hereinafter described, and includes an adapter 406 that is coupled to the distal end 408 of an endoscope device 402 (e.g., a ureteroscope) to treat stones or stone fragments within a target region (e.g., the kidney, ureter) of a patient's body. Similar to the above-described adapter, the adapter 406 includes a proximal portion 448 and a distal portion 450, and the distal portion 450 defines a distal chamber 416 within which stone fragments / particles / debris can be received or held against during laser treatment or other therapies. The adapter 406 includes an outlet 410 for providing fluid to the target region and an inlet passage 412 for applying suction to the target region. However, the outlet 410 of the endoscope device 402 and the imaging system 418 do not extend through any part of the distal portion 450 of the adapter 406 and / or are not longitudinally aligned with the distal portion.

[0099] Similar to the adapter 106, the adapter 406 extends from a proximal end 444 to a distal end 446 and includes a lumen 452 extending therethrough. The adapter 406 includes a proximal portion 448 and a distal portion 450 that are separated from each other by a separator 454 extending across the lumen 452. Similar to the above-described adapter, the wall 456 and the separator 454 along the distal portion 450 of the adapter 406 define a distal chamber 416 within which stone fragments / particles / debris and heated fluid can be contained.

[0100] However, the cross-sectional area of the distal portion 450 is smaller than the cross-sectional area of the proximal portion 448 such that a portion 470 of the separator 454 extends beyond the perimeter of the distal portion 450. The outlet 410 extends longitudinally from a distal opening 468 in the portion 470 of the separator 454 through the proximal portion 448 to the proximal end, which is configured to engage a working passage of the endoscope device 402 through which fluid is configured to be provided to the distal portion 450 and / or the target region external to the distal chamber 416. As Figure 16As shown, the reduced cross-section H of the distal portion 450 also serves to facilitate easy insertion of the adapter through the body orifice.

[0101] The imager passage or opening 462 also extends through a portion 470 that is external to the distal portion 450 of the separator 454. The imager passage / opening 462 is configured to receive an imaging system 418, such as a digital camera or an optical lens. The axis of the imager passage or window 426 is external to the distal portion 450 and is offset from the longitudinal axis of the proximal portion 448 and / or the axis 404 of the endoscope device 402. Although the imaging system 418 is offset with respect to the longitudinal axis of the axis 404 of the endoscope device 402, it provides a field of view F that includes the distal portion 450 of the adapter 406 and the stone and / or stone fragments being treated (shown by the dashed line in Figure 17 ). The adapter 406 may be formed of an optically transparent (e.g., translucent) material such that the stone / fragments / debris received within the distal chamber 416 are visible therethrough.

[0102] Similar to the adapter described above, the inlet passage 412 extends from a distal opening 458 that extends through the separator 454 through the proximal portion 448 to a proximal end that is configured to engage the working passage of the endoscope device 402 through which suction (i.e., negative pressure) can be applied. The inlet passage 412 leads to and communicates with the distal chamber 416 via the distal opening 458. According to an exemplary embodiment, the inlet passage 412 is configured to also receive an energy device therein, such as a laser fiber 420. In other words, when the laser fiber is received within the inlet passage 412, the negative pressure supplied to the inlet passage 412 will apply a suction force around the laser fiber 420.

[0103] In an exemplary embodiment, the inlet passage 412 and / or its distal opening 458 may have a non-circular cross-sectional shape such that when the laser fiber 420 is received therein, the suction force can be applied to the distal chamber 416 through the space between the laser fiber 420 and the inlet passage 412. In one embodiment, the cross-section of the inlet passage 412 may be substantially elliptical. The cross-section is configured such that when the laser fiber 420 is received within the inlet passage 412, the laser fiber 420 is substantially centered therein, e.g., substantially aligned with the central axis of the inlet passage 412. According to an exemplary embodiment, the cross-section of the inlet passage 412 may vary along its length. For example, the distal portion of the inlet passage 412 may have an elliptical cross-sectional shape, while the proximal portion is sized, shaped, and configured to contact, engage, or otherwise align with the working passage of the endoscope device 402.

[0104] According to an exemplary embodiment, the distal chamber 416 includes a tapered inner surface 472 that tapers such that the inner diameter of the distal chamber 416 contracts as it approaches the proximal end of the distal chamber 416. For example, the diameter increases as it approaches the distal opening 458 of the inlet passage 412. When suction is applied through the inlet passage 412, the tapered inner surface 472 converges the stones and / or debris received therein toward the central axis along which the inlet passage 412 extends, such that the stone fragments are substantially aligned with the laser fiber 420.

[0105] Those skilled in the art will understand that only those fragments, particles, debris, or powders that are suitable for passing through the gap between the laser fiber and the inlet passage 412 can pass side by side with the laser fiber 420 and thus be suctioned out of the patient's body. This will prevent any oversized particles or debris from entering through the inlet passage 412 and clogging the inlet passage. Those skilled in the art will also understand that any oversized debris and / or particles at the proximal end of the tapered inner surface 472 can be further fragmented by pulling the laser fiber proximally into the inlet passage 412 and allowing the oversized particles to be suctioned into the inlet passage 412 for further fragmentation via laser treatment.

[0106] The system 400 can be used in a manner substantially similar to the system 100. Specifically, when the shaft 404 is inserted through a body orifice and reaches the target area within the body, suction can be applied through the endoscope device 402 and through the inlet passage 412 such that the stone 40 and / or stone fragments can be suctioned into the distal chamber 416 and / or attracted against, for example, the distal edge 447 of the distal chamber 416. The laser fiber 420 can be inserted through the inlet passage 412 and into the distal chamber 416 to perform laser treatment on the stone, fragmenting the stone into smaller fragments, particles, or powders 42.

[0107] As the stone / stone fragments are laser-treated, fluid is provided via the outlet 410 and suctioned via the inlet passage 412 to provide continuous fluid circulation. Thus, particles small enough to pass through the space between the exterior of the laser fiber 420 and the interior of the inlet passage 412, along with any heat generated via laser treatment, can thereby be removed from the patient's body. As the stone fragments, powders 42 converge toward the proximal end 417 of the distal chamber, the laser fiber 420 can be used to continue to further fragment, break, and / or pulverize the stone for removal.

[0108] As described above with respect to system 100, in some cases, stone fragments / particles that cannot be aspirated out of the body can be captured and retained in the distal chamber so as to be removed from the body when the endoscope device 402 is removed from the body. Those skilled in the art will also understand that, although not explicitly described with reference to system 100, a stone or stone fragment can be retained within or against the distal chamber 416 for movement or migration within the body.

[0109] Although the inlet passage 412 of the adapter 406 is described and shown as having an oval cross-section, those skilled in the art will understand that the inlet passage 412 can have any of a variety of configurations, so long as the inlet passage 412 is sized and shaped to center or align a laser fiber or other energy device received therein along, for example, the central axis of the inlet passage 412, such that a stone or stone fragment received within the distal chamber 416 can also be aligned with the laser fiber or other energy device for laser treatment. The inlet passage 412 should also be shaped such that negative pressure can be applied therethrough to the distal chamber 416 around and / or surrounding the laser fiber 420 received therein.

[0110] For example, in another embodiment, as Figure 18 shown, the inlet passage 512 (e.g., at least its distal portion) has a channel-shaped cross-section that is configured to center a laser fiber 520 received therein (e.g., substantially along the central axis of the inlet passage 512 along which the adapter 406 extends). Stone particles / debris can be aspirated from the distal chamber via the portion of the inlet passage 512 that extends from the laser fiber 520. In yet another example, as Figure 19 shown, the cross-section of the inlet passage 612 (or at least its distal portion) can be substantially cross-shaped. The cross-shaped inlet passage 612 can also be configured to center a laser fiber 620 received therein substantially along the central axis along which the inlet passage 612 extends.

[0111] As Figures 20 - 21 shown, a system 700 according to another exemplary embodiment of the present disclosure is substantially similar to the system 400 described above, except as described below. The system 700 includes an adapter 706 that is mounted or otherwise coupled to the distal end 708 of the shaft 704 of the endoscope device 702 via, for example, a mounting bracket 738 at the distal end 708. The adapter 706 can be substantially similar to the adapter 406 and includes a distal portion 750 that defines a distal chamber 716 into and / or against which a stone or stone fragment can be aspirated for laser treatment, removal, or migration.

[0112] Similar to adapter 406, the cross-section of the distal portion 750 is smaller than the cross-section of the proximal portion 748 of adapter 706. The imaging passage 762 for receiving the imager 718 of the endoscope device 702 extends through the partition 754 and the portion 770 that laterally extends beyond the distal portion 750. However, in this embodiment, the outlet 710 may include a hole 711 that extends through a portion of the wall 756 of the proximal portion 748, such that the fluid provided therethrough is ejected radially outward from the adapter 706. In addition, adapter 706 includes a separate inlet passage 712 and a laser passage 714, which will be described in further detail below.

[0113] The laser passage 714 is substantially similar to the inlet passage 412 described above with respect to adapter 406. Similar to adapter 406, the laser passage 714 longitudinally extends from a distal opening 760 that extends through a portion of the partition 754 through the proximal portion 748 to a proximal end. The partition extends between the distal portion 750 and the proximal portion 748, and the proximal end is configured to align and engage with the working passage of the endoscope device 702. The laser fiber 720 is configured to be inserted into the adapter 706 through the working passage. Thus, the laser passage 714 leads to and communicates with the distal chamber 716 via the distal opening 760.

[0114] In an exemplary embodiment, at least the distal portion 714A of the laser passage 714 has a non-circular cross-section, such that there is a space between the laser fiber 720 received therein and the laser passage 714. In one embodiment, the laser passage 714 has an elliptical cross-section, such that the cylindrical laser fiber 720 received therein is centered and / or aligned along the central axis along which the laser passage 714 extends. In addition, similar to adapter 406, the distal chamber 716 includes a tapered surface 772 that is configured to collect the stone fragments, particles, and debris received therein and align them with the laser fiber 720 for facilitating further laser treatment of the fragments that are too large to pass through the channel opening to reach the inlet passage 712, as described below. In other words, the tapered surface 772 collects the stone fragments, particles, and debris and aligns them with the central axis of the laser passage 714 such that they can be directly exposed to the laser until they are small enough to pass through the channel and into the inlet passage 712.

[0115] In this embodiment, the inlet passage 712 extends through the distal portion 750 and the proximal portion 748. The portion 758 of the inlet passage 712 that extends through the distal portion 750 has a cross-section sized and shaped to prevent oversized particles from passing therethrough. In one embodiment, the portion 758 of the inlet passage 712 that extends through the distal portion has a channel-shaped cross-section, while the portion of the inlet passage 712 that extends through the proximal portion 748 is sized and shaped to receive and / or engage the working passage of the endoscope device 702, through which a negative pressure is configured to be applied. Thus, when a negative pressure is applied through the inlet passage 712, debris or particles that cannot pass through the channel portion 758 of the portion of the inlet passage 712 that extends through the distal portion 750 are collected towards the proximal end of the distal portion 750 and aligned with the laser fiber 720 to facilitate its further laser treatment. When the stone debris is laser-treated, the particles, debris or powder can pass through the adapter 706 along path C (as Figure 20 shown).

[0116] Those skilled in the art will understand that the system 700 can be used in a manner substantially similar to the above-described systems 100, 400. As described above with respect to the above systems, the fluid provided via the outlet 710 and the suction provided via the inlet passage 712 provide a continuous fluid circulation such that stone debris, particles, debris, and / or powder, along with the heat generated by the laser treatment of the stone, are removed from the distal chamber 716 and its immediate surrounding area.

[0117] As Figures 22 - 23 shown, the system 800 can be substantially similar to the above-described systems 100, 400, which includes an endoscope device 802 and an adapter 806 that is configured to be mounted to or otherwise coupled to the distal end 808 of the endoscope device 802. However, the system 800 can be used as a retrofit kit for retrofitting a standard endoscope device 802 that includes a single working passage, and further includes an outer sheath 880 that is configured to be slidably placed on the shaft 804 of the endoscope device 802. The system 800 can be used in a manner substantially similar to the above-described systems.

[0118] As Figure 22As shown, the endoscope device 802 can be a standard endoscope, where the distal end 808 of the shaft 804 is preconfigured with an endoscope cap 848 that includes an inlet passage 812 aligned and / or in communication with the working passage of the shaft 804. In this embodiment, the adapter 806 is configured as a tubular body 807 that is sized, shaped, and configured to be mounted on the endoscope cap 848, such as by a friction fit, such that the adapter 806 is removably coupled thereto. When the adapter 806 is mounted on the endoscope cap 848, a distal chamber 816 is formed therein. Although the system 800 is described and shown as a retrofit kit for retrofitting an endoscope device 802, those skilled in the art will understand that, similar to the adapter described above, the adapter 806 can include a proximal portion configured to be mounted to the distal end 808 of the shaft 804 to serve as the proximal portion of the endoscope cap and a distal portion that defines a chamber, the proximal portion being configured to include passages / openings corresponding to the working passages of any components of the endoscope device 802 and its imaging system.

[0119] The outer sheath 880 extends longitudinally from a proximal end (not shown) to a distal end 882 and includes a lumen 884 extending therethrough. The outer sheath 880 is sized, shaped, and configured to be slidably mounted over the length of the shaft 804. The outer sheath 880 can be placed along the shaft 804 such that the distal end 882 is adjacent to or very close to the distal end 808 of the shaft 804. Once the outer sheath 880 has been positioned on the shaft 804 of the endoscope device 802, a gateway adapter, such as a Tuohy Borst adapter 890 (as Figure 23 shown), can be fastened against the shaft 804 of the endoscope device 802 to lock and seal the outer sheath 880 in place.

[0120] As will be described in further detail below, the space between the exterior 805 of the shaft 804 and the inner surface 886 of the lumen 884 serves as an outlet for delivering fluid to a target site within a patient's body. The fluid can be provided to the lumen 884 via, for example, a side arm 892 of the Tuohy Borst adapter 890.

[0121] When assembling the system 800, as described above, the distal end 808 of the shaft 804 coupled with the adapter 806 can be inserted into the target area (e.g., kidney, ureter) within the patient's body through a body orifice. A negative force can be applied through the working passage of the endoscope device 802 and the inlet passage 812 of the endoscope cap 848 such that the stone or stone fragment is aspirated into and / or against the distal chamber 816. Then, the laser fiber 820 can be inserted through the same working passage and inlet passage 812 to perform laser treatment on the aspirated stone / stone fragment 80. Meanwhile, fluid is provided to the target area through the outer sheath 880, via the space between the exterior 805 of the shaft 804 and the inner surface 886 of the lumen 884, thereby providing a fluid circulation (e.g., continuous fluid circulation) along path D, as Figure 22 shown, to remove stone fragments, particles, powder / debris, and the heat generated by laser treatment of the stone via the working passage.

[0122] As described above with respect to systems 100, 400, 700, this process can be repeated without removing the endoscope device 802 from the patient's body until all the stones / stone fragments have been treated as desired. Also as described above with respect to systems 100, 400, 700, in some cases, the distal chamber and the suction force applied through the working passage can be used to remove, carry, move, and / or migrate stones / stone fragments via the distal chamber 816.

[0123] According to another embodiment, as Figure 24 shown, the system 900 can be substantially similar to the above-described system 800 and includes an adapter 906 and an outer sheath 980 that is configured to retrofit an endoscope device 902 for treating, e.g., kidney stones. The adapter 906 is configured to be removably mounted or otherwise coupled to the distal end 908 of the shaft 904 of the endoscope device 902 (e.g., on the endoscope cap 948), while the outer sheath 980 is configured to be slidably mounted along the length of the shaft 904. The adapter 906 and the endoscope device 902 can be substantially similar to the adapter 806 and the endoscope device 802 described above with respect to system 800 (except as noted below). In a further embodiment, the adapter 906 can be integrally formed with the outer sheath 980.

[0124] However, in this embodiment, the outer sheath 980 includes a tapered portion 986 at its distal end 982 such that the distal end 982 fits around the distal end 908 of the shaft 904. The outer sheath 980 includes an exit opening 988 that extends through the wall 981 adjacent to the distal end 982 such that fluid passes through the space between the exterior of the shaft 904 and the inner surface of the lumen 984 and exits through the exit opening 988 to the target area of the body where the adapter 906 is mounted on the distal end 908. The system 900 can be used in a substantially similar manner to the system 800 described above, providing a continuous fluid circulation from the exit opening 988 through the distal chamber 916 formed via the adapter 906 and through the inlet passage 912.

[0125] According to an alternative embodiment, the distal end 982 can be attached to the shaft 904 to prevent the outer sheath 980 from bending when the endoscope device 902 is inserted through a body orifice into the target area. In one example, the distal end 982 can be attached to the shaft 904 via an elastic member mounted on the distal end 982.

[0126] According to another exemplary embodiment, as Figure 25 shown, the system 1000 can be used as a retrofit kit for retrofitting a standard endoscope device 1002, substantially similar to the systems 800, 900 described above. Similar to the systems 800, 900, the endoscope device 1002 includes an endoscope cap 1048 pre-mounted on the distal end 1008 of the shaft 1004 such that the inlet passage 1012 of the endoscope cap 1048 is aligned and in communication with the working passage of the shaft 1004. However, the system 1000 includes a single outer sheath 1080 configured to be slidably mounted on the endoscope device 1002, rather than separate outer sheaths and adapters as described above with respect to the systems 800, 900.

[0127] The outer sheath 1080 extends longitudinally from a proximal end (not shown) to a distal end 1082 and includes a lumen 1084 extending therethrough. In this embodiment, the outer sheath 1080 includes a distal portion 1006 that is configured to extend distally along the endoscope cap 1048 at the distal end 1008 of the endoscope device 1002 to form a distal chamber 1016. The distal portion 1006 has a smaller diameter than the remaining length 1094 of the outer sheath 1080 such that when positioned on the endoscope device 1002 in the operative configuration, the distal portion 1006 fits around the endoscope cap 1048 via, for example, a friction fit. When the distal portion 1006 fits around the endoscope cap 1048, the distal chamber 1016 is formed by the portion of the distal portion 1006 that extends distally from the endoscope cap 1048 and the distal face 1054 of the endoscope cap 1048.

[0128] Similar to outer sheath 980, the remaining length 1094 may include a tapered distal end 1086 that tapers towards the distal portion 1006. When the distal portion 1006 is assembled around the endoscope cap 1048 in the operative configuration, the remaining length 1094 of the outer sheath 1080 extends along the length of the shaft 1004. Once the outer sheath 1080 has been positioned on the endoscope device 1002 as desired, a gateway adapter (such as the Tuohy Borst adapter 890 described above with respect to system 800) may be fastened onto the proximal end of the outer sheath 1080, against the shaft 1004, to lock and seal the outer sheath 1080 in place on the shaft.

[0129] Similar to outer sheath 980, outer sheath 1080 includes an outlet 1010 defined by an outlet opening 1088 that extends through a portion of the wall 1081 of the outer sheath 1080 near the distal portion 1006. The outlet opening 1088 extends through the wall 1081 such that fluid can pass through the space between the exterior of the shaft 1004 and the inner surface of the lumen 1084 and out of the outlet opening 1088 to the target area of the body into which the distal end 1008 of the endoscope device 1002 has been inserted. As described above, system 1000 may be used in a manner substantially similar to systems 800, 900. In an exemplary embodiment, suction may be applied through the working passage of the shaft 1004 and through the inlet passage 1012 such that a kidney stone is aspirated into or against the distal chamber 1016. A laser fiber may also be inserted through the inlet passage 1012 to apply laser energy to the stone to break up and / or shatter the stone. Fluid is provided to the target area simultaneously such that a continuous fluid circulation is provided from the outlet opening 1088 through the distal chamber 1016 and proximally through the inlet passage 1012 of the endoscope device 1002 such that stone fragments, particles, and / or debris along with any heated fluid (heated via laser treatment or other treatment of the stone) may be removed from the target area.

[0130] According to another exemplary embodiment, as Figure 26As shown, system 1100 can be substantially similar to system 1000 described above, which includes an outer sheath 1180 configured to retrofit an endoscope device 1002 for treating kidney stones. Endoscope device 1102 is substantially similar to endoscope device 1002 and includes a single inlet passage 1112 through which suction can be provided to a target area into which the distal end of endoscope device 1102 is inserted, and a laser fiber can be inserted into the target area through this inlet passage. Substantially similar to outer sheath 1080, outer sheath 1180 is configured to slide longitudinally on endoscope device 1102 such that the distal portion 1106 extends distally along endoscope cap 1148 at the distal end 1108 of the endoscope axis 1104 of endoscope device 1102, and the remaining length 1194 extends proximally along the length of endoscope axis 1104. Similar to outer sheath 1080, distal portion 1006 is sized, shaped, and configured to have a smaller diameter than the remaining length 1194 such that distal portion 1006 fits onto endoscope cap 1148, for example, via a friction fit, to define a distal chamber 1116 therein.

[0131] However, unlike the single outlet opening as described with respect to outer sheath 1080, outer sheath 1180 includes a pair of outlet openings 1188 that extend through the wall 1181 of the remaining length 1194 near the distal portion 1106. The outlet openings 1188 can additionally have any of a variety of sizes and shapes. In one embodiment, the pair of outlet openings 1188 extend through a portion of the remaining length 1194 and are diametrically opposed to each other. However, those skilled in the art will appreciate that the two outlet openings 1188 can have any of a variety of configurations and positions relative to each other, as long as the outlet openings 1188 are configured to facilitate fluid flow out of its lumen 1184 through the outlet openings 1188 to the exterior of outer sheath 1180, e.g., to a target area into which the distal end of endoscope device 1102 is inserted. System 1100 can be used in a manner substantially similar to systems 800 - 1000 described above to provide a continuous fluid circulation from the outlet openings 1188, through the distal chamber 1116, and through the inlet passage 1112 of endoscope axis 1104, thereby providing proximal suction through endoscope device 1102.

[0132] As Figures 27 - 28As shown, a system 1200 according to another exemplary embodiment can be substantially similar to the systems 800, 900 described above, and includes an adapter 1206 configured to retrofit an endoscope device 1202 for use in treating, for example, kidney stones. However, the system 1200 does not require an outer sheath because the endoscope device 1202, although otherwise substantially similar to the endoscope devices 802 - 1102, includes two working channels extending through its shaft 1204, a first working channel for providing suction to a target area inserted into the distal end of the endoscope device 1202, and a second working channel for providing fluid to the target area, as will be described in further detail below.

[0133] The endoscope device 1202 can be substantially similar to the endoscope devices 802 - 1102 described above, and includes a shaft 1204 and an endoscope cap 1248 mounted on its distal end 1208. However, the shaft 1204 includes two working channels extending longitudinally through the shaft 1204. The first working channel is in communication with an inlet channel 1212 of the endoscope cap 1248 and is substantially similar to the endoscope devices 802 - 1102 such that suction can be applied therethrough and a laser fiber 1220 can be inserted therein. The endoscope cap 1248 can be substantially similar to the endoscope caps described above and includes openings 1262, 1264 for accommodating other components of the endoscope device 1202 (e.g., an imager of an imaging device and an LED).

[0134] However, in an exemplary embodiment, the second working channel is not in communication with any opening / passage in the endoscope cap 1248. Instead, the shaft 1204 includes an outlet opening 1210 extending through the wall of the shaft 1204 such that the second working channel leads to the outside of the shaft 1204 via the outlet opening 1210. The outlet opening 1210 can extend through a portion of the shaft 1204 near the distal end 1208 such that fluid can be delivered to the target area via the second working channel and the fluid exits the shaft 1204 via the outlet opening 1210.

[0135] The adapter 1206 can be substantially similar to the adapters 806, 906 described above with respect to the systems 800, 900. In particular, the adapter 1206 can have a generally tubular body 1207 and is sized, shaped, and configured to be mounted on the endoscope cap 1248 such that a portion of the tubular body 1207 extends distally from the endoscope cap 1248, as Figure 28 shown, to define a distal chamber 1216. In one exemplary embodiment, the adapter 1206 can be mounted on the endoscope cap 1248 via a friction fit. In another exemplary embodiment, the proximal end 1244 of the adapter includes an elastic connector 1296, e.g., an elastic band configured to clamp the endoscope cap 1248 and / or the distal end 1208 of the shaft when the adapter 1206 is mounted on the shaft 1204.

[0136] Those skilled in the art will understand that the system 1200 can be used in a manner substantially similar to the above-described systems 800 - 1100 to provide a continuous fluid circulation. In particular, fluid is provided via an exit opening 1210 that extends through the wall of the shaft 1204 and is aspirated through the distal chamber 1216 and the inlet passage 1212 of the shaft 1204 to remove any stone fragments / debris from the target area, along with any heat generated by laser treatment of the stone.

[0137] As Figures 29 - 30 Shown, the system 1300 is substantially similar to the above-described system 1200, including a double-lumen endoscope device 1302 (i.e., including a first working passage and a second working passage) and an adapter 1306 that is configured to be mounted on its distal end 1308. The endoscope device 1302 is substantially similar to the above-described endoscope device 1202 and includes a first working passage that extends longitudinally through the shaft 1304 of the endoscope device 1302, which communicates with and is aligned with an inlet opening 1312 of an endoscope cap 1348 attached to the distal end of the shaft 1304. However, in this embodiment, instead of an exit opening extending laterally through the wall of the shaft 1304, a second working passage that extends longitudinally through the shaft 1304 communicates with and is aligned with an exit opening 1310 that extends through the endoscope cap 1348.

[0138] In addition, the adapter 1306 includes a proximal portion 1349 and a distal portion 1350. The proximal portion is configured to be mounted on the distal end 1308 of the endoscope device 1302 (e.g., on the endoscope cap 1348), and the distal portion extends distally from the proximal portion 1349 such that when the proximal portion 1349 is mounted on the distal end 1308, the distal portion 1350 of the adapter 1306 defines a distal chamber 1316 therein. Similar to the above-described adapter 1206, the adapter 1306 may include an elastic connector 1396 at the proximal end 1344 of the adapter 1306 for clamping the endoscope cap 1348 on which the adapter 1306 is mounted.

[0139] The distal chamber 1316 is aligned with the inlet opening 1312 such that the target stone can be aspirated against the distal chamber 1316 via a negative force applied through the first working passage and the inlet opening 1312. However, similar to the adapter 406 of the system 400, the distal portion 1350 of the adapter 1306 has a smaller cross-section than the proximal portion 1349 such that the exit opening 1310 of the endoscope cap 1348 and additional openings (e.g., an imager opening 1362 for accommodating a portion of the imaging system of the endoscope device 1302) do not extend through any part of the distal portion 1350 of the adapter 1306 and / or are not longitudinally aligned with any part of the distal portion of this adapter.

[0140] In an exemplary embodiment, when the proximal portion 1349 of the adapter 1306 is mounted on the distal end 1308, the distal face 1354 of the proximal portion 1349 extends beyond the perimeter of the distal portion 1350 and includes openings 1363, 1311 corresponding to the imager opening 1362 and the exit opening 1310 of the endoscope cap 1348, respectively. In other words, the imager opening 1362 and the exit opening 1310 extend longitudinally offset from the central axis along the axis along which the endoscope cap 1348 lies, and the distal portion 1350 extends from the proximal portion 1349 along this central axis. Thus, fluid is configured to be provided to the target area outside the distal portion 1350, i.e., outside the distal chamber 1316, and the field of view includes the distal portion 1350. At least the distal portion 1350 of the adapter 1306 may be formed of an optically transparent (e.g., translucent) material such that stones / fragments / debris received within the distal chamber 1316 are visible therethrough.

[0141] Similar to the adapter 406, the distal chamber 1316 of the adapter 1306 may include a tapered inner surface 1372 that tapers such that the inner diameter of the distal chamber 1316 decreases toward the proximal end of the distal chamber 1316. Thus, when suction is applied via the inlet opening 1312, the tapered inner surface 1372 converges stones, fragments, and / or debris toward the central axis along which the inlet opening 1312 extends to align the stone fragments with the laser fiber 1320 inserted through the inlet opening 1312.

[0142] The system 1300 can be used in a manner substantially similar to the system described above to provide a continuous cycle for removing broken stones / debris and any heat generated by the laser treatment of the stones from the target area. As Figure 30 shown, fluid is provided to the target area via the exit opening 1310 and is suctioned through the distal chamber 1316 and the inlet opening 1312 along with stone fragments / debris and / or any heat generated by the laser treatment to be removed from the body and the target area.

[0143] According to another exemplary embodiment, as Figures 31 - 32As shown, a system 1400 according to another exemplary embodiment may be substantially similar to the above-described system 1300, which includes a double-lumen endoscope device 1402 and an adapter 1406 configured to be placed on an endoscope cap 1448 that is mounted to a distal end 1408 of a shaft 1404 of the endoscope device 1402. The endoscope device 1402 is substantially similar to the endoscope device 1302 and includes a first working passage and a second working passage that longitudinally extend through the shaft 1404. The first working passage communicates with and is aligned with an inlet opening 1412 of the endoscope cap 1448, and the second working passage communicates with and is aligned with an outlet opening 1410 of the endoscope cap 1448. The adapter 1406 may also be substantially similar to the adapter 1306 described above with respect to the system 1300. In particular, the adapter 1406 includes a proximal portion 1449 and a distal portion 1450. The proximal portion is configured to be mounted on the endoscope cap 1448, and the distal portion extends distally from the proximal portion to form a distal chamber 1416 therein. The distal portion 1450 has a smaller cross-section than the proximal portion 1449.

[0144] However, in this embodiment, when the adapter 1406 is mounted on the endoscope cap 1448 in an operative configuration, the distal portion 1450 extends over the inlet opening 1412 and an imager opening 1462, while the outlet opening 1410 remains offset from the distal portion 1450. In other words, the imager opening 1462 and the inlet opening 1412 lead to and / or communicate with the distal chamber 1416, while the outlet opening 1410 is aligned with a corresponding outlet opening 1411 at the distal end of the proximal portion 1449 that does not communicate with and / or is not aligned with the distal chamber 1416. Thus, fluid is provided to the target area via the outlet opening 1410 outside of the distal portion 1450, while fluid and / or stone fragments / debris are aspirated through the distal chamber 1416 of the distal portion 1450 and proximally through the inlet opening 1412, as Figure 32 shown.

[0145] In an exemplary embodiment, adapter 1406 may be configured to be substantially similar to adapter 206 described above. Similar to adapter 206, the wall 1456 of adapter 1406 along its distal portion 1450 includes a longitudinal recess 1470 along its outer perimeter, which longitudinal recess 1470 is aligned with the central axis along which the exit opening 1411 of adapter 1406 (and the exit opening 1410 of endoscope device 1402 when adapter 1406 is mounted thereon in an operative configuration) extends. Thus, as described above, fluid can pass distally through the exit openings 1410, 1411 and directly reach the target area along the outer surface (e.g., along the longitudinal recess 1470). Also similar to adapter 206, the wall 1456 along the distal portion 1450 may taper towards its distal end, thereby facilitating the insertion of system 1400 into the target area via, for example, a body orifice.

[0146] Similar to system 1300, laser fiber 1420 is described and shown as passing through the inlet opening 1412 and into the distal chamber 1416 to treat stones and / or stone fragments that are aspirated into and / or against the distal chamber. However, as described above with respect to adapter 206, those skilled in the art will understand that endoscope device 1402 may include a third working passageway that is configured to communicate with the distal chamber 1416 in an operative configuration, and laser fiber 1420 may be inserted via this third working passageway to treat any stones / fragments. System 1400 may be used in a manner that is substantially similar to the systems described above, providing a continuous fluid circulation from the exit opening 1410 and through the distal chamber 1416 and the inlet opening 1412 during the treatment (e.g., laser treatment) of a target stone to draw stone fragments, debris, and / or heat away from the target area.

[0147] As Figures 33 - 34 shown, a system 1500 according to another exemplary embodiment of the present disclosure may be substantially similar to system 1200 described above, which includes an adapter 1506 that is configured to be mounted on a endoscope cap 1548 at the distal end 1508 of the shaft 1504 of endoscope device 1502 to form a distal chamber 1516 therein. However, endoscope device 1502 in this embodiment may include three working passageways, a first working passageway that communicates with and is longitudinally aligned with the inlet opening 1512, and a second working passageway that communicates with the exit opening 1510 that extends laterally through the wall of endoscope cap 1548.

[0148] The endoscope device 1502 may include a third working passage that extends longitudinally through the shaft 1505 and communicates with and is longitudinally aligned with a corresponding opening 1564 in the endoscope cap 1548. In this embodiment, the laser fiber 1520 may be inserted into the distal chamber 1516 through the first working passage and the inlet opening 1512, as Figure 34 shown, or through the third working passage and the corresponding opening 1564 of the adapter 1506, such that the entire inlet opening 1512 may be freely available to aspirate stone fragments, debris, and / or fluid therethrough.

[0149] In an exemplary embodiment, the adapter 1506 may be substantially similar to the adapter 1206 and include a tubular body 1507, the proximal end 1544 of which is configured to engage the endoscope cap 1548 via, for example, a friction fit or a resilient connector. In this embodiment, the adapter 1506 further includes an outlet opening 1511 that extends through its wall 1554 such that when the adapter 1506 is mounted on the endoscope cap 1548 in an operating configuration, the outlet opening 1511 of the adapter 1506 is aligned with the outlet opening 1510 of the endoscope cap 1548 such that fluid may pass through the second working passage of the endoscope device 1502 and out through the outlet openings 1510, 1511. The adapter 1506 may additionally include other openings 1565 that extend through the wall 1554 and that correspond in size, shape, and position to other features of the endoscope device 1502, such as a pressure sensor. Alternatively, the pressure sensor may be mounted to the wall 1554 of the adapter 1506 at a desired location along the wall.

[0150] As described above, the inlet opening 1512 and the corresponding opening 1564 (for receiving the laser fiber 1520 or another tool) communicate with and lead to the distal chamber 1516 such that the stone and / or stone fragments may be treated via, for example, laser treatment as described above. Similar to the above-described system, when treating a target stone, the system 1500 provides continuous fluid circulation, as Figure 34 shown. In particular, fluid is provided to the target area via the outlet openings 1510, 1511 that extend laterally through the endoscope cap 1548 and the adapter 1506. The target stone may be treated via the laser fiber 1520, which may be inserted into the distal chamber 1516 via the inlet opening 1512 or the opening 1564. The resulting stone fragments, debris, and / or heat are aspirated from the target area through the distal chamber 1516 and the inlet opening 1512 to be withdrawn from the body.

[0151] Those skilled in the art will understand that the above embodiments can be changed without departing from the concept of the present invention. It should also be understood that the structural features and methods associated with one of the embodiments can be incorporated into other embodiments. Therefore, it should be understood that the present invention is not limited to the specific embodiments disclosed, but that modifications are also covered within the scope of the present invention as defined by the appended claims.

Claims

1. A system for treating stones in a hollow organ or body passage, comprising: An endoscope device, the endoscope device including an endoscope cap and a shaft longitudinally extending from a proximal end to a distal end, the shaft being configured to be inserted into a target area within the hollow organ or body passage and including a working passage extending therethrough, the endoscope cap being coupled to the distal end of the shaft such that an inlet opening of the endoscope cap communicates with and is aligned with the working passage; An adapter having a generally tubular body mountable on the endoscope cap such that a distal chamber defined by the adapter and the endoscope cap leads to and communicates with the inlet opening of the endoscope cap, whereby when negative pressure is applied through the working passage, suction is applied through the distal chamber to attract a target stone into or against the distal chamber from the target area; And An outer sheath longitudinally extending from a proximal end to a distal end and configured to be slidable over the length of the shaft, the outer sheath being configured to deliver fluid to the target area via a space extending between the interior of the outer sheath and the exterior of the shaft.

2. The system according to claim 1, wherein, The outer sheath is configured to deliver fluid to the target area via its distal end to provide a continuous fluid circulation from the distal end of the outer sheath proximally through the distal chamber and the working passage.

3. The system according to claim 1 or 2, wherein, The distal end of the outer sheath is configured to enclose the shaft, and the outer sheath includes an outlet opening extending through a wall thereof adjacent to the distal end for providing fluid to the target area.

4. The system according to claim 3, wherein, The distal end of the outer sheath includes an elastic band.

5. The system according to any one of claims 1-4, wherein, The proximal portion of the adapter is configured to be mounted on the endoscope cap via a friction fit.

6. The system according to any one of claims 1-5, wherein, The adapter and the outer sheath are integrally formed.

7. The system according to any one of claims 1-6, further comprising: A laser fiber configured to be inserted through the working passage and the inlet opening into the distal chamber to treat a stone aspirated into or against the distal chamber.

8. A system for treating stones in a hollow organ or body passage, comprising: An endoscope device, the endoscope device including an endoscope cap and a shaft longitudinally extending from a proximal end to a distal end, the shaft being configured to be inserted into a target area within the hollow organ or body passage and including a first working passage and a second working passage extending therethrough, the endoscope cap being coupled to the distal end of the shaft such that an inlet opening of the endoscope cap communicates with and is aligned with the first working passage; And An adapter extending from a proximal end to a distal end and including a lumen extending therethrough, the proximal portion of the adapter being configured to be mounted on the endoscope cap such that a distal portion of the adapter and the endoscope cap define a distal chamber therein, whereby when negative pressure is applied through the first working passage, suction is applied through the distal chamber to attract a target stone into or against the distal chamber.

9. The system according to claim 8, wherein, The shaft of the endoscope device includes an exit opening extending through its wall, the exit opening being positioned near the distal end of the shaft and in communication with a second working passage of the endoscope device to provide fluid to a target area.

10. The system according to claim 8 or 9, wherein, The proximal portion of the adapter is configured to engage the endoscope cap via a friction fit.

11. The system according to any one of claims 8 - 10, wherein, The proximal portion of the adapter includes an elastic connector configured to fit the proximal portion around the endoscope cap.

12. The system according to any one of claims 8-11, wherein, The second working passage of the endoscope device is in communication with and aligned within an exit opening extending through the endoscope cap.

13. The system according to claim 9, wherein, The distal portion of the adapter has a smaller cross-section than the proximal portion of the adapter, the distal portion of the adapter extending from the proximal portion of the adapter such that the distal chamber is in communication with the inlet opening and longitudinally offset from the longitudinal axis along which it extends through the endoscope cap from the exit opening, such that fluid passing through the exit opening is delivered to the target area outside the distal chamber.

14. The system according to claim 13, wherein, The distal portion includes a longitudinal recess extending along its outer surface, the longitudinal recess being aligned with the longitudinal axis of the exit opening.

15. The system according to claim 12, wherein, The adapter has a generally tubular body, the proximal portion of the adapter including an exit opening extending through its wall such that when the adapter is mounted on the endoscope cap, the exit opening of the adapter is aligned with the exit opening of the endoscope cap, the exit opening of the endoscope cap extending laterally through the side wall of the endoscope cap.

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