Kidney stone treatment system

Abstract

The invention discloses a kidney stone removal system. Assembly of the kidney stone removal system comprises a handle mechanism, a nozzle tip and a guiding device. The handle mechanism employs a trigger capable of controlling perfusion and vacuum / suction. A trigger in a pressing trigger mechanism may communicate the state of vacuum / suction and infusion to a user by providing increased resistance at different pressing points. The infusion and vacuum / suction are closed when the trigger is in an initial position (undepressed). When the trigger is in a fully depressed position, perfusion and vacuum / suction are open. When the trigger is in an intermediate position, infusion may be opened while vacuum / aspiration remains closed. The nozzle includes one or more perfusion ports at a distal end of the nozzle, each having a perfusion port departure angle of 30 to 60 degrees for directing perfusion fluid forward and laterally from the distal end of the nozzle. The guide device is configured to be removably positioned in the nozzle for receiving a debris crushing device, such as a laser device. The guiding device is configured to prevent unexpected movement of the fragment breaking device when the fragment breaking device is positioned in the nozzle while flowing fluid and fragments through the fragment breaking device and through the vacuum tube.

Description

Field of the Invention

[0001] The present invention relates generally to systems, devices and methods for guiding the removal of body objects and, more particularly, to mechanisms for instilling and removing objects such as kidney stones. Background of the Invention

[0003] Kidney stones are a common medical problem that negatively affects millions of people worldwide. Kidney stones consist of one or more lumps of solid material, usually composed of crystals, that form in certain parts of an individual's urinary tract, including the ureters, kidneys, and / or bladder. Kidney stones can range in size from small (less than about 1 cm) to very large (more than 4 cm) and can cause severe pain to an individual and damage the kidneys. The vast majority of stones treated by surgeons are smaller than 1 cm.

[0004] The recommended treatment for kidney stone removal varies based on a number of factors, including kidney stone size, number of kidney stones, and kidney stone location. The most common kidney stone treatments are shock wave lithotripsy (using ultrasound to break up the stones), ureteroscopy (using an endoscope inserted through the bladder to break up and remove the stones), and percutaneous nephrolithotomy (using an endoscope inserted through a sheath placed into the kidney from the patient's back to break up and remove the stones).

[0005] The largest kidney stones are usually removed by percutaneous nephrolithotomy or nephrolithotomy. In these procedures, a small incision is made in the patient's back near the kidney, and a sheath is inserted into the kidney to accommodate a larger endoscope that is used to break up and remove the stone. The stone can be removed directly through the tube or broken into small pieces inside the patient's body and then removed by vacuum or other known methods.

[0006] Nephrolithotomy, nephrolithotomy, and other invasive procedures that require an incision in the skin have many disadvantages. Namely, such surgical techniques may require the patient to be heavily anesthetized, the surgery is more complicated, poses a higher risk of infection and complications to the patient, and the surgery requires a large incision in the patient's body, which may leave scars. In addition, due to the invasiveness of the surgery, percutaneous surgery is generally not recommended for smaller kidney stones (e.g., less than 1 cm), depending on the size and location of the stone.

[0007] Traditionally, smaller kidney stones have been treated using less invasive techniques, including through ureteroscopy. During ureteroscopy, the surgeon typically inserts a ureteroscope through the urethra, through the bladder and ureters, so that the surgeon can directly visualize the kidney stone, which may be located in the ureter or kidney. If the kidney stone is small enough to pass easily through the urethra, the surgeon can directly remove the kidney stone using a basket lithotripsy device, or the surgeon can use a laser or other fragmentation device to break the kidney stone into smaller fragments. A laser lithotripsy device is inserted through the ureteroscope and is used to break larger kidney stones into smaller fragments. After breaking the kidney stone into smaller fragments, the surgeon removes the laser or fragmentation device and inserts a basket or extraction catheter to capture the kidney stone fragments under direct visualization of the ureteroscope. After retrieving some kidney stone fragments, the surgeon removes the basket from the patient and pours out the kidney stone fragments. This process is repeated until clinically significant kidney stones and kidney stone fragments have been broken into pieces and removed from the body.

[0008] Obviously, this procedure is extremely time-consuming, expensive, and inefficient, as the surgeon needs to insert and remove the endoscope and basket from the patient multiple times to completely remove the kidney stone and kidney stone fragments. There are other disadvantages to using a basket to capture kidney stones or kidney stone fragments, namely that the basket is difficult to place close to the kidney stone fragments and difficult to manipulate in a way that effectively retrieves the fragments. The training required for such a procedure is not insignificant, and the basket stone extraction technique is very difficult even for the most skilled surgeons. In addition, the surgeon's hands are easily fatigued due to the long time required to manipulate the kidney stone extraction basket. In addition, the patient is required to receive local anesthesia and / or remain motionless for a long time. In addition, the basket stone extraction device can cause irritation to the urinary tract due to repeated insertion and removal of the basket.

[0009] Therefore, there is an unmet need for new devices and methods that can remove kidney stones in a minimally invasive manner. Summary of the Invention

[0010] According to one aspect of the present invention, a kidney stone removal mechanism is provided. The mechanism comprises an irrigation tube; a vacuum tube; and a trigger mechanism. The trigger mechanism comprises a trigger operable by a user. The trigger may be located at the proximal end of the kidney stone removal mechanism. The trigger mechanism is operable to selectively retract, close and open the irrigation tube to irrigate the treatment area when the user operates the trigger, and to selectively activate the vacuum in the vacuum tube to remove part or all of the kidney stones when the user operates the trigger. The user presses the trigger to gradually open the irrigation tube. In one embodiment, the trigger comprises a first protrusion, so that the user operates the trigger to cause the first protrusion to selectively retract, close and open the irrigation tube. The user presses the trigger to cause the first protrusion to gradually open the irrigation tube. In one embodiment, the trigger may comprise a second protrusion, so that the user presses the trigger to cause the second protrusion to selectively activate the vacuum in the vacuum tube. The user presses the trigger to cause the second protrusion to gradually activate the vacuum in the vacuum tube. The kidney stone removal mechanism may further include a catheter connected at its proximal end to the distal end of the kidney stone removal mechanism. The catheter has a distal tip at its distal end. A steering mechanism may be located at the proximal end of the kidney stone removal mechanism. The steering mechanism is operable to steer the distal tip to facilitate removal of some or all of the kidney stone. The steering mechanism may include at least one wire connected between the steering mechanism and the catheter for moving the distal tip to a desired position to facilitate removal of some or all of the kidney stone.

[0011] The first protrusion may include a roller. The second protrusion may include a roller. The trigger may include a third protrusion, and the trigger mechanism may include a first detent, the first detent selectively engaging with the third protrusion to alert the user to a predetermined amount of depression of the trigger. The first detent may include an edge of a protrusion located inside the trigger mechanism, or may include an edge of a recess located inside the trigger mechanism. The third protrusion of the trigger may include a roller. The kidney stone removal mechanism may further include a second detent to alert the user to a full amount of depression of the trigger. The second detent may include the protrusion located inside the trigger mechanism. The second detent may include an opposite edge of the recess located inside the trigger mechanism. The roller may engage with the opposite edge of the recess to alert the user to a full amount of depression of the trigger.

[0012] According to an embodiment, the trigger mechanism may be located at the proximal end of the kidney stone removal mechanism so that it can be operated by a user with a thumb. The trigger mechanism may be located at the proximal end of the kidney stone removal mechanism so that it can be operated by a user with a finger. The steering mechanism may be located at the proximal end of the kidney stone removal mechanism so that it can be operated by a user with a thumb.

[0013] According to an embodiment, the kidney stone removal mechanism further comprises a resilient device that interacts with the trigger mechanism to return the trigger mechanism to an initial position in response to a user releasing the trigger. The resilient device may comprise a spring.

[0014] According to an embodiment, the kidney stone removal mechanism further comprises a vacuum activated tube connected to the vacuum tube. The second protrusion can activate the vacuum in the vacuum tube by pinching the vacuum activated tube. The second protrusion can activate the vacuum in the vacuum tube by covering a port of the vacuum activated tube.

[0015] According to one aspect of the present invention, a kidney stone removal mechanism is provided, comprising: an irrigation tube configured to carry a fluid and having a portion passing through a trigger mechanism; and a bypass structure connected to the irrigation tube at two locations and configured to allow fluid to flow from a first portion of the irrigation tube to a second portion of the irrigation tube without passing through the portion of the irrigation tube located within the trigger mechanism. The trigger mechanism includes a trigger operable by a user. The trigger mechanism is operable to selectively retract, close, and open the first irrigation tube to irrigate a treatment area when the user operates the trigger. The bypass structure may include a flow restriction. The user pressing the trigger may cause the irrigation tube to gradually open. The kidney stone removal mechanism may further include a vacuum tube configured to be activated by the trigger mechanism. The kidney stone removal mechanism may further include: a catheter connected at its proximal end to the distal end of the kidney stone removal mechanism, the catheter having a distal tip at its distal end; and a steering mechanism located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of part or all of the kidney stone.

[0016] According to another aspect of the present invention, the present invention provides a kidney stone removal mechanism, comprising: an irrigation tube; a vacuum tube; and a flow indicator mechanism, which includes a flow indicator connected to a stone trap assembly. In one embodiment, the flow indicator may include one or more blades that move in response to the flow of fluid or air. The kidney stone removal mechanism may further include: a catheter, the catheter being connected at its proximal end to the distal end of the kidney stone removal mechanism, the catheter having a distal tip at its distal end; and a steering mechanism, which is located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of part or all of the kidney stone.

[0017] According to one aspect, the kidney stone removal mechanism may further include a nozzle. The nozzle may include: a vacuum tube lumen in communication with the vacuum tube and sized to remove kidney stones or kidney stone fragments; and one or more irrigation ports in communication with the irrigation tube, each of the irrigation ports being located at a distal end of the nozzle and each having an irrigation port departure angle of 30 to 60 degrees for directing irrigation fluid forward and laterally from the distal end of the nozzle. In one embodiment, at least one of the irrigation ports has an arc shape.

[0018] According to another aspect of the present invention, the present invention provides a kidney stone removal mechanism, comprising: a kidney stone removal catheter; and a nozzle assembly, which is included at the distal end of the catheter. The nozzle may include a vacuum lumen of a size suitable for removing kidney stones or kidney stone fragments, and one or more irrigation ports located at the distal end of the nozzle. At least one of the irrigation ports has an irrigation port departure angle of 30 to 60 degrees for directing irrigation fluid forward and laterally from the distal end of the nozzle. In one embodiment, the kidney stone removal mechanism comprises: a first irrigation port, which is configured to direct irrigation fluid forward but not in a radially divergent direction; and a second irrigation port, which is configured to direct irrigation fluid in a radially divergent direction. In one embodiment, at least two of the irrigation ports have different opening sizes, different shapes, and / or different irrigation port departure angles. In one embodiment, the first irrigation port is one of a circular, elliptical, or arcuate shape, and the second irrigation port has a different shape from the first irrigation port and is one of a circular, elliptical, or arcuate shape. The first irrigation port may be located directly between a second irrigation port and a third irrigation port, wherein the arc distance between the first irrigation port and the second irrigation port is different than the arc distance between the first irrigation port and the third irrigation port.

[0019] In one embodiment, the kidney stone removal mechanism further comprises an image sensor and a light source. The nozzle may include an upper recess for receiving the image sensor and the light source. The kidney stone removal mechanism may also include a distal manifold configured to be inserted into the proximal end of the nozzle, the distal manifold having a conduit for directing an irrigation fluid to the irrigation port of the nozzle. The kidney stone removal mechanism may also include an axis manifold configured to be connected to the distal manifold, the axis manifold having an irrigation lumen, the irrigation lumen for directing an irrigation fluid to the conduit of the distal manifold.

[0020] The nozzle may include a distal face having a rounded edge or a curved edge. The vacuum lumen may be offset from the center of the nozzle. The nozzle may include at least one conduit for providing a fluid path between the conduit and the irrigation port. The at least one conduit may include a divider for directing fluid to the irrigation port.

[0021] According to one aspect of the present invention, the present invention provides a kidney stone removal system, comprising: a vacuum tube; and a laser guide configured to be detachably inserted into the vacuum tube. The laser guide comprises: a tubular body having a lumen configured to receive a laser device; and a wing extending from a distal section of the tubular body, the wing being used to guide the distal section of the tubular body in the vacuum tube and to create a flow gap between the tubular body and the vacuum tube.

[0022] In one embodiment, the tubular body is configured so that when the tubular body is fully inserted into the vacuum tube and placed in an operating position, the tubular body does not extend beyond the distal end of the vacuum tube. In one embodiment, the guide comprises 2 to 4 wings. In one embodiment, the guide consists of 3 or 4 wings, and the circumferential distance between each pair of adjacent wings is the same. In one embodiment, the guide consists of 3 or 4 wings, and the circumferential distance between the first pair of adjacent wings is different from the circumferential distance between the second pair of adjacent wings. The first pair of adjacent wings share a common wing with the second pair of adjacent wings. In some embodiments, at least two of the gaps have different sizes.

[0023] In one embodiment, each wing portion comprises a middle section having a rectangular shape, the middle section transitioning into a tapered end section that slopes downward into the tubular body. In some embodiments, each wing portion has a variable thickness that increases along the longitudinal axis from the proximal end of the wing portion to the distal end of the wing portion. In some embodiments, each wing portion has a longitudinal axis that is angled relative to the longitudinal axis of the tubular body.

[0024] According to another aspect of the present invention, the kidney stone removal system further comprises an actuator for moving the tubular body within the vacuum tube. In one embodiment, the actuator comprises: a biasing element; and a shaft portion coupled to the tubular body, such that actuation of the biasing element causes the shaft portion to move the tubular body in a front-to-back direction within the vacuum tube. In one embodiment, the shaft portion is configured to be removably coupled to the proximal end of the tubular body. In an alternative embodiment, the shaft portion is permanently attached to the proximal end of the tubular body.

[0025] In one embodiment, the biasing element comprises a band portion coupled to a distal segment of the shaft portion. The actuator may also comprise a cylindrical housing coupled to the band portion and configured to receive the shaft portion, such that inward compression and release of the band portion causes a portion of the shaft portion to telescopically move into and out of the cylindrical housing. The actuator comprises a channel for receiving the laser device. The channel is configured to communicate with the lumen of the tubular body.

[0026] According to another aspect of the present invention, the present invention provides a catheter assembly, comprising: a vacuum tube; and a guide device, which is configured to be removably positioned in the vacuum tube, for receiving a debris breaking device. The guide device is configured to prevent accidental movement of the breaking device when the breaking device is positioned at the distal end of the vacuum tube, while allowing fluid and debris to flow through the breaking device and through the vacuum tube. The catheter system may also include an actuator, the actuator being used to move the guide device within the vacuum tube to clear the debris. The breaking device may be a laser fiber.

[0027] According to another aspect of the present invention, the present invention provides a kidney stone removal method using all embodiments of the present invention. According to one aspect of the present invention, the present invention provides a kidney stone removal method, which comprises operating the kidney stone removal mechanism as described above and in the present invention.

[0028] BRIEF DESCRIPTION OF THE DRAWINGS

[0029] Various aspects of the present invention will now be described in detail with reference to the accompanying drawings which are not drawn to scale:

[0030] Figure 1 is a perspective schematic diagram of a kidney stone treatment system according to an embodiment.

[0031] Figure 2 is a perspective view of a kidney stone removal mechanism according to an embodiment.

[0032] Figure 3 yes Figure 2 Rear view of the mechanism shown.

[0033] Figure 4 yes Figure 2 Side view of the mechanism shown.

[0034] Figure 5 yes Figure 2 Front view of the mechanism shown.

[0035] Figure 6 is an exploded view of a trigger activation mechanism according to an embodiment.

[0036] Figures 7 to 9 Shown are successive positions of a trigger according to an embodiment.

[0037] Fig.10 is a reverse view of a trigger activation mechanism according to an embodiment.

[0038] Fig.11 and Fig.12 Shown are successive positions of a trigger in a trigger activation mechanism according to an embodiment.

[0039] Fig.13 and Fig.14 Shown are successive positions of a trigger in a trigger activation mechanism according to an embodiment.

[0040] Fig.15 is a picture of a trigger activation mechanism according to an embodiment.

[0041] Fig.16 is a front view of a kidney stone removal mechanism of an embodiment.

[0042] Fig.17 is a side view of a kidney stone removal mechanism of an embodiment.

[0043] Fig.18 is a rear view of the kidney stone removal mechanism of the embodiment.

[0044] Figures 19 to 21 Shown are successive positions of a trigger according to an embodiment.

[0045] Fig. 22 yes Figures 16 to 21 A close-up perspective view of the trigger and distal tip control mechanism is shown.

[0046] Fig.23 is an exploded view of a trigger mechanism according to an embodiment.

[0047] Fig.24 yes Fig.23 Assembly drawing of the trigger mechanism shown.

[0048] Figure 25 to Figure 27 Shown are successive positions of a trigger mechanism according to an embodiment.

[0049] Fig.28A kidney stone treatment system according to an embodiment is shown.

[0050] Fig.29 Shows Fig.28 A portion of the kidney stone removal mechanism is shown.

[0051] Fig.30 A view showing a portion of a kidney stone removal mechanism according to an embodiment.

[0052] Figure 31 to Figure 34 According to the embodiment Fig.30 Successive positions of flip-flops in the structure shown.

[0053] Fig.35 and Fig.36 A schematic diagram of a vacuum / suction control system and method according to an embodiment is shown.

[0054] Fig.37 and Fig.38 Shown are successive positions of a trigger in a trigger activation mechanism according to an embodiment.

[0055] Fig.39 A flow bypass structure of a mechanism according to an embodiment is shown.

[0056] Fig.40 A cross section of a flow bypass structure of a mechanism according to an embodiment is shown.

[0057] Fig.41 A cross section of a flow bypass structure of a mechanism according to an embodiment is shown.

[0058] Fig.42 A cross section of a flow bypass structure of a mechanism according to an embodiment is shown.

[0059] Fig.43 is a view of a kidney stone removal mechanism according to an embodiment.

[0060] Fig.44 is a rotated and enlarged view of a portion of a kidney stone removal mechanism according to an embodiment.

[0061] Fig.45 is an exploded view of a stone trap assembly according to an embodiment.

[0062] Fig.46 and Fig.47 are two views of a flow indicator mechanism according to an embodiment.

[0063] Fig.48A and Fig.48B is a perspective view of a distal assembly according to an embodiment.

[0064] Fig.49Aand Fig.49B 1 and 2 are a perspective view and a perspective exploded view, respectively, of a distal tip assembly according to an embodiment.

[0065] Fig.50A , Fig.50B and Fig.50C is an end cross-sectional view of a distal assembly according to an embodiment.

[0066] Fig.51A , Fig.51B , Fig.52A , Fig.52B , Fig.53A , Fig.53B , Fig.54A , Fig.54B , Fig.55A , Fig.55B , Fig.56 , Fig.57 , Fig.58A , Fig.58B , Fig.59A and Fig.59B Nozzle tips are shown according to various embodiments.

[0067] Fig.60 A distal assembly according to an embodiment is shown.

[0068] Fig.61 A distal assembly according to an embodiment is shown.

[0069] Fig.62A , Fig.62B and Fig.62C A view of an embodiment of a nozzle tip of a distal assembly is shown.

[0070] Fig.63A A schematic diagram showing the test equipment used to determine the affected area of ​​nozzle tip design.

[0071] Fig.63B This is a photo of the test results when determining the affected area of ​​the nozzle tip design.

[0072] Fig.64 A cross-sectional view of a segment of a catheter shaft assembly is shown.

[0073] Fig.65 is a partial perspective view of an implementation scheme of the guide.

[0074] Fig.66 is a front view of an implementation scheme of the guide.

[0075] Fig.67 is a schematic front end view of an embodiment of a guide positioned within a vacuum tube.

[0076] Fig.68is a schematic diagram of a distal segment of an embodiment of a guide.

[0077] Fig.69A and Fig.69B are top plan views showing various embodiments of the wings or extensions of the guide.

[0078] Fig.70 is a partial side plan view of an embodiment of a guide.

[0079] Fig.71A is a perspective view of an embodiment of an actuator for actuating a guide.

[0080] Fig.71B is a top plan view of an embodiment of an actuator.

[0081] Fig.72 is a perspective view of an embodiment of an actuator. DETAILED DESCRIPTION OF THE INVENTION

[0083] Disclosed herein are systems, devices, and methods for guided removal of objects within the body. Specifically, the systems, devices, and methods may be adapted to pass through compact areas (e.g., the urethra) and remove debris (e.g., kidney stones or kidney stone fragments) by suction through a vacuum tube. The term "kidney stone" as used herein may refer to kidney stone fragments, including fragments produced by therapeutic fragmentation of kidney stones (e.g., using the device described herein or by another device).

[0084] Figure 1An embodiment of a treatment system 10 for removing debris (e.g., kidney stones) is shown. The system 10 includes a handle mechanism 12 from which a catheter 14 extends. The system 10 includes a handle mechanism 12 from which a catheter 14 extends. In the embodiments described below, the handle 12 can be configured to provide, for example, a single trigger design that includes or consists of the following two modes: active perfusion mode only (i.e., active perfusion on / vacuum off) and a combination of active perfusion mode and vacuum mode (i.e., active perfusion on / vacuum on). In the embodiments described below, the handle 12 can be configured to provide, for example, a single trigger design that includes or consists of the following three modes: passive perfusion on / active perfusion off / vacuum off; passive perfusion on / active perfusion on / vacuum off; passive perfusion on / active perfusion on / vacuum on. In one embodiment, even in the vacuum off mode, there may be a minimum amount of passive negative pressure. Certain examples of flow design allow for an uninterrupted conduit between the end of the device and the vacuum source, allowing for high flow when the vacuum is activated and minimal or no flow when the vacuum is not activated. The catheter 14 may include various ports and lumens, including a vacuum lumen and an irrigation lumen extending along the length of the catheter 14. The system 10 may also include a camera (digital visualization and lighting, such as a video chip and LED) located at the end, distal face, or distal portion of the catheter 14 to provide real-time imaging to the physician. A distal assembly 16 is located at the distal end of the catheter 14 for irrigation and removal of debris with the aid of negative pressure applied through the vacuum lumen. A handle mechanism 12 allows the physician to hold and operate the system 10. The handle mechanism 12 may include features that allow the physician to operate various functions of the system, including the camera, vacuum pressure, irrigation volume and irrigation pressure, and operability of the catheter 14. For example, the handle mechanism 12 may include mechanical and electronic controls that allow the physician to adjust the amount of negative pressure, adjust the amount of irrigation fluid discharged, and steer the catheter through tortuous anatomical passages by using wheels and / or levers attached to the cable, as is well known in the art. The system 10 may be coupled to a control unit 18 via a connector 20. The control unit 18 may control or assist in controlling operational aspects of the system 10. For example, the control unit 18 may control or assist in controlling visualization aspects of the system 10. The connector 20 may be a wired connection and / or a wireless connection.

[0085] Handle mechanism

[0086] Figure 2A handle mechanism 12 for achieving kidney stone removal according to an embodiment is shown. A finger grip portion 22 extends along a portion of the length of the mechanism 12. An optional ledge portion 24 is located above the position of the user's hand when the user holds the mechanism 12. Above the optional ledge portion 24 is a trigger 26, which is part of a trigger mechanism to be described later. The trigger mechanism controls vacuum (or suction) and airflow, as well as the perfusion operation of the mechanism 12. The user can operate the trigger 26 with one of his fingers. A distal tip steering controller 28 is located at the proximal portion of the mechanism 12. The user's thumb can control the positioning and / or steering of the distal tip of the catheter by operating a lever 30. The mechanism 12 can use various types of catheters, including but not limited to the catheters shown and described in U.S. Patent No. US11,116,530. U.S. Patent No. US11,116,530 shows and describes one or more pull wires that can be attached to the lever 30 to make the distal tip of the catheter turn by operating the lever 30. Figure 2 Also shown are vacuum / suction port 32 and irrigation port 34, as well as catheter strain reliever 36. Stone trap container 38 receives extracted kidney stones and / or fragments through port 40. Access or working channel port 42 allows access to a catheter (not shown) for introduction of a therapeutic tool such as a laser into the distal end of the catheter.

[0087] Figure 3 A rear view of the handle mechanism 12 is shown. Figure 3 In FIG. 2 , the vacuum port 32 , irrigation port 34 and catheter strain reliever 36 can be seen, as well as the stone trap container 38 and the distal tip steering control 28 . Figure 4 A side view of the mechanism 12 is shown. Figure 4 In the Figure 2 The finger grip 22, with the projection 24 located thereon, allows the user's hand to fit over the access or working channel port 42. The vacuum port 32, irrigation port 34 and catheter strain relief 36 are all located at the bottom of the mechanism 12, behind the stone trap container 38. Port 40 is also visible, which allows the kidney stone or kidney stone fragments or kidney stone portions to be deposited into the stone collector container 38. Figure 5 It is a front view of the mechanism 12, in which many Figure 2 The finger grip 22, with the projection 24 located thereon, allows the user's hand to fit over the access or working channel port 42. The catheter strain relief 36 is located at the bottom of the mechanism 12, behind the stone catcher container 38. The port 40 is also visible, which allows the kidney stone or kidney stone portion to be deposited into the stone catcher container 38.

[0088] Figure 6 is an exploded view of the top portion of the mechanism 12 . Figure 6 The components shown together form the trigger mechanism assembly 44. Figure 6 From top to bottom in the figure, the screw or bolt 46 passes through the washer 48 and the opening 50 of the trigger mechanism 52. The trigger mechanism 52 includes protrusions 54, 56 and 58. The functions of these protrusions during the actuation of the trigger mechanism 52 will be described below in conjunction with Figure 7-9 The screw or bolt 46 also passes through a spring 60 or other resilient device and is received by a screw / bolt receptacle 62. In some embodiments, the bolt 46 securely secures the trigger to a base plate boss that captures the spring 60. The spring 60 provides resiliency to the trigger mechanism 52 so that when the user releases or removes pressure on the trigger 26, the trigger mechanism 52 returns to its original home position. The spring 60 or other resilient device is located in an opening 64 of a mechanism housing or body 66. The mechanism body 66 also includes a first stop 68 and a second stop 70, the functions of which will be discussed below in conjunction with the present invention. Figure 7-9 In some embodiments, the mechanism body 66 may include more or fewer stop members. When the handle mechanism 12 is assembled, the mechanism housing 66 is not visible. Figure 6 In the following figures, mechanism housing 66 is exposed to facilitate description of the function of trigger mechanism 52. An irrigation tube (not shown) enters through opening 72, passes through opening 74, under cover portion 76, and extends through opening 78. A vacuum activation tube (not shown) is located within mechanism housing 66 and extends through opening 80.

[0089] See also Fig.35 and Fig.36 , which shows a schematic diagram of a vacuum / suction control system and method 82. A suction outlet tube 84 includes a suction opening 86, which is connected to a vacuum / suction source (not shown). The flow direction through the suction outlet tube 84 is arrow S. A suction target tube 88 includes a target opening 90, which is connected to a portion of the device near the suction / vacuum target area. Fig.36 The configuration is shown with the flow direction through the suction targeting tube 88 being arrow T. The activation tube 92 includes an activation opening 94 that is open to ambient air. An activation clamping mechanism 96 is located adjacent the activation tube 92 and is operable in the direction of arrow P from a first position (eg, a position that allows fluid to flow through the activation tube 92 in the direction of arrow B) to a position (eg, a position that allows fluid to flow through the activation tube 92 in the direction of arrow B). Fig.35 ) to a second position (as shown) that blocks fluid flow from the activation opening 94 through the activation tube 92. Fig.36). The system and method 82 shows that activation of the clamping mechanism 96 can control the vacuum / suction flow. The vacuum source (not shown) can be set to provide a constant suction force (e.g., 200 mmHg), and the activation clamping mechanism 96 provides on / off control of the vacuum / suction by opening or closing the activation tube 92. Fig.35 In the configuration shown, the activation clamping mechanism 96 is positioned so that air flows through the activation tube 92 in the direction of arrow B, through the suction outlet tube 84 in the direction of arrow S, and out to the vacuum / suction source. Fig.35 In the illustrated configuration, little or no airflow flows from the target area through the suction target tube 88 to the suction outlet tube 84. Fig.35 In the configuration shown, no (or relatively little) suction is applied to the target area, and the vacuum in the target area is turned off. Fig.36 In the configuration shown, the activation clamping mechanism 96 is positioned so that no air flows through the activation tube 92. Fig.36 In the configuration shown, all airflow flows from the target area in the direction of arrow T through the suction target tube 88 to the suction outlet tube 84 and out of the suction opening 86 in the direction of arrow S. Fig.36 In the configuration shown, the vacuum is turned on in the target area.

[0090] Figure 7-9 The following diagram shows the successive positions of the trigger 26. Figure 6 In the embodiment of the present invention, the trigger 26 is in the unpressed position. When the trigger 26 is in this position, the vacuum and irrigation in the handle mechanism 12 are turned off. In some embodiments, the irrigation bypass structure can allow a minimum amount of irrigation to flow even when the trigger 26 is in the unpressed position. The protrusion 54 clamps the irrigation tube 98. The protrusion 56 does not contact the stopper 68. The protrusion 58 can contact the vacuum activation tube 100 (e.g., see also Fig.35 and Fig.36 The trigger mechanism 52 is resiliently engaged by a spring 60 or other resilient means so that when the user releases the trigger 26, the trigger 26 returns to its initial position, thereby turning off irrigation and vacuum. In some embodiments, irrigation is partially turned on at a minimum level, and when the trigger 26 returns to its initial position, the vacuum is turned off. Figure 8, the trigger 26 is partially depressed until the protrusion 56 contacts the stop 68 in the mechanism body 66, indicating to the user that the first stopping point in the operation has been reached. When the trigger 26 is in this position, the protrusion 54 partially disengages from the irrigation tube 98, slightly opening the irrigation tube 98 and allowing some irrigation (or, in some embodiments, full irrigation flow) to occur. The protrusion 58 partially closes the vacuum activation tube 100, but air can still flow through the vacuum activation tube 100, so the vacuum in the target area is still off. Fig. 9 , the trigger 26 is fully depressed. The protrusion 56 travels past the stop 68 and abuts against the stop 70. In this position, the protrusion 58 clamps the vacuum activation tube 100, thereby turning on the vacuum at the target area. The protrusion 54 further opens the irrigation tube 98 so that irrigation can continue and kidney stones and / or kidney stone fragments can be removed and deposited in the stone trap container 38 ( Figure 2-5 ). Fig.10 Shown with Figure 7-9 1 and 10. The device 20 is a view of the mechanism body 66 from the opposite side. The irrigation tube 98 has an inlet 104 and an outlet 106. The activation tube 100 runs through the mechanism body 66. The trigger 26 has a protrusion (not shown) that interacts with the irrigation tube 98 and the activation tube 100 depending on the degree of depression of the trigger 26. In the foregoing description of the kidney stone removal mechanism, the functions of the inlet 104 and the outlet 106 are interchangeable, so that the element 104 operates as an irrigation outlet and the element 106 operates as an irrigation inlet.

[0091] Fig.11 1 shows a portion of a kidney stone removal mechanism 108 according to an embodiment. The mechanism housing or body 110 contains an irrigation tube 112 having an irrigation inlet 114 and an irrigation outlet 116. A trigger 118 has a protrusion 120 that interacts with the irrigation tube 112. When the trigger 118 is not depressed, as shown in FIG. Fig.11 As shown, the protrusion 120 closes or at least retracts the irrigation tube 112. A spring 122 or other resilient means moves against the force of the user depressing the trigger 118 so as to return the trigger 118 to its undepressed state when the user releases the trigger 118. When depressed, the trigger 118 rotates about a pivot point 124 so that the protrusion 120 moves away from the irrigation tube 112 to open the tube and enable irrigation. Fig.12 Shown with Fig.11 Similar structure, except that Fig.12 In the embodiment of the present invention, the trigger 118 is pressed so that the protrusion 120 moves away from the irrigation tube 112 to open it. Fig.13 Shown with Fig.11 A similar structure is shown on the opposite side of the mechanism body 110. The trigger 118 is Fig.13 The position in Fig.11When the trigger 118 is in this position, the vacuum line (not shown) in position 126 will not be clamped and the vacuum or suction will be turned off. Fig.13 and Fig.11 By comparison, when vacuum or suction is turned off, irrigation is also turned off. Fig.14 Shown with Fig.13 Similar structure, except that Fig.14 In the embodiment of the present invention, the trigger 118 is pressed, so that the vacuum line (not shown) in the position 126 will be clamped, so that the vacuum or suction will be turned on. Fig.14 and Fig.12 By comparison, when vacuum or suction is on, irrigation is also on, similar to the other described embodiments.

[0092] and Figures 7 to 9 The embodiments shown are different. Figures 11 to 14 The intermediate depressed positions of the trigger 118 are not shown. However, one of ordinary skill will recognize that the kidney stone removal mechanism 108 is capable of providing the trigger 118 with a range of depressed positions. Figures 7 to 9 Similar to the illustrated embodiment, the trigger 118 has an intermediate depressed position whereby the irrigation tube 112 will loosen slightly to allow irrigation to flow, while the vacuum tube (not shown) will tighten slightly so that the vacuum or suction will still be off.

[0093] Fig.15 is a photograph of a portion of a kidney stone removal mechanism 108 according to an embodiment, the kidney stone removal mechanism being similar to Fig.11 The mechanism body 110 includes an infusion tube 112 having an infusion inlet 114 and an infusion outlet 116. The trigger 118 has a protrusion 120 that interacts with the infusion tube 112. When the trigger 118 is not pressed, Fig.15 As shown, the protrusion 120 closes or at least retracts the irrigation tube 112. A spring 122 or other resilient device moves against the force of the user depressing the trigger 118 so as to return the trigger 118 to its undepressed state when the user releases the trigger 118. When depressed, the trigger 118 rotates about a pivot point 124 so that the protrusion 120 moves away from the irrigation tube 112 to open the tube and enable irrigation. The trigger 118 is in a Fig.15 The position in Fig.13 126. When the trigger 118 is in this position, the vacuum line (not shown) in position 126 will not be clamped, so the vacuum or suction will be turned off. When the vacuum or suction is turned off, the irrigation is also turned off. In the foregoing description, the functions of the inlet 114 and the outlet 116 are interchangeable, so that element 114 operates as an irrigation outlet and element 116 operates as an irrigation inlet.

[0094] Figure 16-22A kidney stone removal mechanism 128 is shown in accordance with an embodiment. A finger grip portion extends along a portion of the length of the mechanism. A trigger mechanism 130 is located at the proximal end of the kidney stone removal mechanism 128. A distal tip steering mechanism 132 is also located at the proximal end of the kidney stone removal mechanism 128, enabling manipulation of the catheter, particularly the distal end of the catheter, to position the distal end as desired for kidney stone fragmentation and / or removal. The catheter is connected to a catheter strain reliever 134. A stone catcher container 136 receives removed kidney stones and / or fragments thereof. A working channel port 138 allows access to the catheter for insertion of devices and tools. Fig.16 A front view of the kidney stone removal mechanism 128 is shown with the catheter strain reliever 134 shown in more detail. It also shows a front view of the stone trap container 136. The access or working channel port 138 allows access to the catheter to allow for the introduction of a treatment tool (e.g., a laser) into the distal end of the catheter. Fig.16 A front view of trigger 130 and a side view of distal tip steering mechanism 132 are also shown. Fig.17 Shown is a side view of a kidney stone removal mechanism 128. The vacuum outlet 140 and irrigation inlet 142 are visible, as well as the catheter strain reliever 134, stone catcher container 136, and finger grip 143. Fig.18 A rear view of the kidney stone removal mechanism 128 is shown, showing the vacuum outlet 140 and the irrigation inlet 142, as well as the catheter strain reliever 134. The distal tip steering mechanism 132 can also be seen. Figure 19-21 A close-up of the trigger 130 of the kidney stone removal mechanism 132 is shown, i.e., from Fig.19 The unpressed position in Fig.21 to the fully pressed position. Fig. 22 Shows Figure 19-21 Perspective side view.

[0095] Fig.23 An exploded view of a trigger mechanism assembly 144 according to an embodiment is shown. Bolt 146 and washer 148 pass through slot 150 in trigger mechanism 152. Irrigation tube 154 has an irrigation inlet 166 and an irrigation outlet 168. Spring 156 biases trigger 158 toward an undepressed position. Pivot 160 fits through hole 162 in trigger mechanism 152 to receive trigger mechanism 152. When a user actuates trigger 158, trigger mechanism 152 rotates about pivot 160. Opening 164 leads to a vacuum outlet (not shown). Fig.24 Shows Fig.23 Assembled version of the trigger mechanism shown. Fig.23 The components discussed are Fig.24 The same reference numerals are used throughout.

[0096] Figure 25-27The following diagram shows the successive positions of the trigger 158 of the trigger mechanism 144, namely, Fig.25 The unpressed position in Fig. 27 The fully pressed position in the and the corresponding movement of related components. Fig.25 In the embodiment shown, the trigger 158 is in its normal position due to the bias applied by the spring 156 or other resilient means (as shown in the previous figures). The roller 167 is mounted on a pin 169, located at one end of a lever arm or lever 170. At the other end 172 of the lever arm or lever 170 is a mount 174 to which the lever arm or lever 170 is attached. With this structure, when the trigger 158 is pressed, the lever arm or lever 170 pivots about the mount 174. Similarly, as shown in FIG. Fig.25 As shown, the roller 167 is located away from the opening 164, which leads to the vacuum outlet (not shown). The roller 167 presses the irrigation tube 154 to close the irrigation. Fig.25 Trigger position shown, with both prime and vacuum off. Fig.25 Further shown are protrusions 176 and 178, the functions of which will be described with reference to Fig.26 and Fig. 27 Give a description. Fig.26 An intermediate position of the trigger 158 is shown, as well as a corresponding intermediate position of the roller 167, which is closer to the opening 164. Pressing the trigger 158 causes the lever arm or lever 170 to rotate about the mount 174. Pressing the trigger 158 to Fig.26 The degree shown will cause the roller 167 to contact the protrusion 178, thereby providing greater resistance and signaling to the user that the trigger 158 is in the intermediate position. In this position, the roller 167 applies less pressure to the irrigation tube 154. Fig.26 Trigger position shown, vacuum is still off but priming is on. Fig. 27 The fully depressed position of the trigger 158 is shown. In this position, the user depresses the trigger 158 causing the roller 167 to pass over the protrusion 178, covering the opening 164, and further away from the irrigation tube 154. The roller 167 moves upwardly against the protrusion 176, indicating to the user that the trigger 158 is fully depressed. In this position, both the vacuum and irrigation are on so that the kidney stone and / or kidney stone fragments can be removed.

[0097] Fig.28 A mechanism 180 for kidney stone removal is shown according to an embodiment. Fig.28, a user may use the distal tip steering controller 182 to position and / or steer the catheter 184 to perform appropriate operations to fragment and / or remove the kidney stone. One or more pull wires (not shown) may facilitate positioning and / or steering the catheter 184. User control of the trigger 186 may control the operation of the trigger mechanism (as further described herein) to control vacuum and perfusion through the catheter 184. The handle portion 188 is sized for a user to grasp the mechanism 180, wherein the user's thumb operates the distal tip steering controller 182 and one of the user's fingers operates the trigger 186. Alternatively, the user's thumb may operate the trigger 186 and the user's finger may operate the distal tip steering controller 182. Similarly, as Fig.28 As shown, port 190 is connected to a vacuum source (not shown). The catheter 184 is attached to a catheter strain reliever 192. In one embodiment, port 194 provides a working channel into the catheter 184 to facilitate the introduction of a treatment tool (eg, a laser) into the distal end of the catheter 184. Fig.29 An enlarged view of the distal tip steering control 182 and trigger 186 and the upper portion of the handle portion 188 are shown.

[0098] Fig.30 Shows the available Fig.28 and Fig.29 An example of a trigger mechanism of the illustrated embodiment. The irrigation tube 196 has an inlet 198 connected to an irrigation source and an outlet 200 connected to the distal tip (not shown) to irrigate the desired area. The position and size of the column 202 are suitable for accommodating the distal tip steering controller 182, which can be attached to the column 202 via one or more pins (also not shown) passing through holes 204 in the column 202. As part of the distal tip steering controller 182, a pull wire (not shown) can be provided to guide the movement and position of the distal tip of the catheter so that appropriate actions are performed to manipulate the tip into the appropriate position for kidney stone removal surgery. Pressing the trigger 186 causes the trigger 186 to rotate about the pivot pin 206 and causes the roller 208 attached via the pin 210 to move from the position shown to a position thereby covering the port 212, which is connected to the ambient air through the activation tube (not shown). That is, the function of covering the port 212 is the same as that of the distal tip steering controller 182. Fig.35 and Fig.36 The activation clamping mechanism 96 shown is the same because when the port 212 is covered, ambient air no longer flows to the vacuum source. When the port 212 is not covered, the vacuum of the target area is turned off. When the port 212 is covered, the vacuum of the target area is turned on.

[0099] Figure 31-34The gradual depression of the trigger 186 is shown. In these figures, for ease of description, the post 202 remains in the same position, that is, the distal tip steering control 182 is not operated. Fig.31 The trigger 186 is shown in an unpressed position. In this position, the roller 208 closes or at least retracts the irrigation tube 196, while the port 212 is open. The roller 208 is set apart from the contact edge 214. This position corresponds to both vacuum and irrigation being closed. Fig.32 , the initial depression of the trigger 186 causes the trigger 186 to rotate slightly to the right about the pivot pin 206, thereby moving the roller 208 slightly upward and to the right. In this position, the irrigation tube 196 is further opened, allowing irrigation of the area to be treated. This positioning of the trigger 186 corresponds to an irrigation-only state, where the vacuum remains off because the port 212 remains open. Fig.33 , further pressing the trigger 186 causes the trigger 186 to rotate slightly to the right about the pivot pin 206, thereby causing the roller 208 to move slightly upward and to the right. When the roller 208 is in this position, the port 212 remains open, so the vacuum remains off. The irrigation tube 196 is less squeezed, allowing more irrigation to the affected area. In this position, according to an embodiment, the roller 208 contacts the edge 214, which acts as a stop. When the roller 208 contacts the edge 214, the user is alerted by the resistance to pressing the trigger 186. Fig.34 214 and further depresses the trigger 186, the trigger 186 rotates further upward and to the right until the roller 208 covers the port 212. At this point, the roller 208 is located in the notch 216 and cannot move further. In this way, the user knows that the trigger has been pressed the maximum amount. When the trigger 186 is in this position, the port 212 is closed (e.g., Fig.35 and Fig.36 ), priming remains on, and vacuum is on.

[0100] Fig.37 and Fig.38 An embodiment of a mechanism 218 is shown that includes an irrigation bypass structure 220 for always providing a minimum irrigation flow through the mechanism. The irrigation bypass structure 220 may be implemented with any of the embodiments disclosed above and is not limited to the mechanism 218. Fig.37 and Fig.38A mechanism head 222 having protrusions 224, 226, and 228 is shown, which functions the same as disclosed in other embodiments of the present invention, using a single trigger 230 to control irrigation and vacuum / suction. In some cases, the user may wish to maintain a minimum irrigation flow through the mechanism 218 without activating the trigger 230. In some embodiments of the mechanism disclosed in the present invention, the protrusion 224 can be implemented so that the protrusion 224 does not completely close the irrigation tube against which the protrusion 224 abuts. Such an implementation may be suitable for some situations, but may not provide a sufficiently well-defined minimum flow in other situations. That is, the degree of incomplete closure of the irrigation tube may vary beyond the desired value. Fig.37 and Fig.38 An embodiment is provided in which a more well-defined minimum irrigation flow rate can be provided through the irrigation bypass structure 220 than through an incomplete closure of the irrigation tube.

[0101] Fig.37 A flow path FP is shown in which most of the irrigation fluid flows from the inlet 232 through the irrigation tube 234 until the protrusion 224 stops the flow by squeezing the irrigation tube 234 and closing it. A small amount of irrigation fluid flows from the inlet 232 through the irrigation bypass structure 220 and flows to the outlet 236, which is connected to the distal end of the stone removal device. Thus, in this embodiment, at least some irrigation fluid always flows to the distal end of the stone removal device. Fig.38 The configuration is shown in which the trigger 230 is pressed, thereby moving the protrusion 224 away from the irrigation tube 234 and opening the irrigation tube 234. With the irrigation tube 234 open, irrigation fluid can flow along the flow path FP from the inlet 232 through the mechanism head 222 and toward the outlet 236. A small amount of irrigation fluid can still flow through the bypass structure 220, but the majority of irrigation fluid flows through the mechanism head 22.

[0102] Fig.39 A perfusion bypass structure 220 is shown having an inlet tube 238 defining an inlet lumen 240 connecting the inlet 232 with the supply outlet 236, and an outlet tube 242 defining an outlet lumen 244 connecting the return inlet 246 with the outlet 236. A perfusion tube (not shown) connects the supply outlet 236 with the return inlet 246 and delivers perfusion fluid through the mechanism head and trigger activation mechanism of the various embodiments disclosed herein. The inlet tube 238 is connected to the outlet tube 242 by a bypass 250, which includes a pair of bypass tubes 252 connected by a bypass connector 254. Fig.39Bypass 252 is shown as a hose barb and bypass connector 254 is a tube, but other equivalent configurations of similar structure may be used. Bypass 250 includes flow restrictions 256, which are narrow lumens (narrower than the diameter of inlet lumen 240) that limit the amount of irrigation fluid that can flow through bypass 250. Fig.39 Two flow restrictions 256 are shown, because for manufacturing efficiency, it may be necessary to produce two identical parts and connect them via connector 254 to form the perfusion bypass structure 220, but a single flow restriction 256 may be sufficient to provide the functionality of the perfusion bypass structure 220 disclosed herein. In some embodiments, the inner diameter of the flow restriction 256 may be in the range of about 5% to about 30% of the inner diameter of the inlet lumen 240, and in some embodiments, the inner diameter of the flow restriction 256 may be in the range of about 20% of the inner diameter of the inlet lumen 240. For example, when the inner diameter of the inlet lumen 240 is about 2.5 mm, the inner diameter of the flow restriction 256 may be about 0.5 mm. Other specific inner diameters within the disclosed percentage range are within the range of the bypass structure. When the flow rate varies as the fourth power of the diameter, the ratio of the flow restriction 256 to the inner diameter of the inlet lumen 240 directly affects the ratio of the flow through the trigger mechanism to the flow through the bypass structure. Other factors, such as surface tension and pressure drop, may affect the degree to which the flow rate is governed by this power law relationship.

[0103] Fig.40 An alternative embodiment of an irrigation bypass structure 258 is shown, with a cross section represented by a plane defined along line C in an embodiment similar to the irrigation bypass structure 220. The bypass structure can be implemented with any of the embodiments disclosed above. The irrigation bypass structure 258 includes an inlet tube 260 (which defines an inlet lumen 262) and an outlet tube 264 (which defines an outlet lumen 266). The lumens are connected by an irrigation tube (not shown) that delivers irrigation fluid through the mechanism head and trigger activation system disclosed herein. Fig.40 An inlet lumen 262 and an outlet lumen 266 are shown, which are also connected by a bypass 268 formed by a first bypass fitting 270 and a second bypass fitting 272. The first bypass fitting 270 and the second bypass fitting 272 are connected via complementary features and form a fluid seal via an O-ring 274. When connected, the first bypass fitting 270 and the second bypass fitting 272 form a conduit for fluid bypass, and the conduit includes a flow restriction 276, the lumen of which is narrower than the inlet lumen 262. Therefore, the role of the irrigation bypass structure 258 is to provide a well-defined minimum irrigation flow when the irrigation tube in the mechanism head is closed by the trigger mechanism.

[0104] Fig.41Another alternative embodiment of an irrigation bypass structure 278 is shown, with a cross-section represented by a plane defined along line C in embodiments similar to irrigation bypass structures 220 and 258. The bypass structure can be implemented with any of the embodiments disclosed above. The irrigation bypass structure 278 includes an inlet tube 280 (which defines an inlet lumen 282) and an outlet tube 284 (which defines an outlet lumen 286). The lumens are connected by an irrigation tube (not shown) that delivers irrigation fluid through the mechanism head and trigger activation system disclosed herein. Fig.41 An inlet lumen 282 and an outlet lumen 286 are shown, each also connected by a bypass 288 formed by a first bypass fitting 290 and a second bypass fitting 292. The first bypass fitting 290 is connected to the second bypass fitting 292 via complementary features and forms a fluid seal via a compressible member 294, which is formed of a resiliently flexible material and includes an internal flow restriction 296. The compressible member 294 is similar in shape or function to an O-ring or seal in that it provides a fluid seal, but it also provides a lumen in the form of a flow restriction 296 that has a predefined diameter when the first bypass fitting 290 is connected to the second bypass fitting 292. The predefined diameter of the flow restriction 296 is narrower than the diameter of the inlet lumen 282. Thus, the function of the irrigation bypass structure 278 is to provide a well-defined minimum irrigation flow when the irrigation tube in the mechanism head is closed by the trigger mechanism.

[0105] Fig.42 Another alternative embodiment of an irrigation bypass structure 298 is shown, with a cross-section represented by a plane defined along line C in embodiments similar to irrigation bypass structures 220, 258, and 278. The bypass structure can be implemented with any of the embodiments disclosed above. The irrigation bypass structure 298 includes an inlet tube 300 (which defines an inlet lumen 302) and an outlet tube 304 (which defines an outlet lumen 306). The lumens are connected by an irrigation tube (not shown) that delivers irrigation fluid through the mechanism head and trigger activation system disclosed herein. Fig.42 An inlet lumen 302 and an outlet lumen 306 are shown, which are also connected by a bypass 308 formed by a first bypass fitting 310 and a second bypass fitting 312. The first bypass fitting 310 and the second bypass fitting 312 are connected via complementary features and form a fluid seal via an O-ring 314, which is formed of a resilient flexible material. The second bypass fitting 312 also includes an internal flow restriction 316, which has a narrower diameter than the inlet lumen 300. Therefore, the role of the irrigation bypass structure 298 is to provide a well-defined minimum irrigation flow when the irrigation tube in the mechanism head is closed by the trigger mechanism.

[0106] The various flow control mechanisms and bypass structures described in the present invention can be selectively located in a unit that is separate from the handle of the device. In this case, a flexible perfusion tube and a flexible vacuum line connect the separate unit to the handle. The user can control the separate unit via a foot pedal, a touch screen, or other similar activation mechanism. The mechanisms in the separate unit can be controlled by mechanical, electromechanical, electromagnetic, or other similar control methods. In one embodiment, the separate unit is a reusable unit similar to or included in the control unit 18. In this embodiment, the control unit 18 provides perfusion fluid and negative pressure to the system in addition to imaging control.

[0107] Fig.43 A mechanism 12 for achieving kidney stone removal is shown in accordance with an embodiment. The lower portion of the mechanism includes a stone trap container 38 in fluid communication with a vacuum inlet 32. Fig.44 yes Fig.43 A rotated and enlarged view of the mechanism 12 within the illustrated box W is shown, and illustrates the location of the flow indicator 318 on the mechanism 12. The flow indicator 318 provides a visual (and optionally audible) indication of whether air and / or fluid is flowing through the mechanism 12 and out to the vacuum inlet 32. The lack of fluid flow through the mechanism 12 may indicate that there is a blockage somewhere in the fluid path within the stone removal device. The blockage may be located in the catheter segment or the mechanism 12, and it is important to resolve such blockages to prevent over-pressurization of the kidney by continuing to perfuse the kidney in the presence of the blockage.

[0108] Fig.45is an exploded view of a stone trap assembly 320 that is configured as part of the mechanism 12 and can be implemented with any of the above-described embodiments. A flow indicator 322 is contained within a flow indicator housing 324, and an O-ring 326 seals the flow indicator housing 324 through a flow indicator cover 328, which is transparent or translucent so that a user can observe the movement of the flow indicator 322. An axle 330 allows the flow indicator 322 to rotate in the presence of flow. Alternative configurations of the flow indicator are within the scope of the present invention, such as any configuration that visibly moves in response to flow within the housing. The flow indicator housing 324 is connected to the stone trap container cap assembly 332 by a fluid seal (e.g., using an O-ring 334). The stone trap container cap assembly 332 is connected to the stone trap container 336 via a stone trap container seal 338. The stone trap container cap assembly 332 is also connected to the inflow assembly 340. In use, the direction of flow of fluid (including kidney stone fragments) in the stone trap assembly 320 is through the inflow assembly 340, which is connected to the catheter segment of the stone removal device and to the stone trap container 336. Both fluid and air are drawn upward through the stone trap container filter 342, which keeps the fragments within the stone trap container 336, but allows the fluid and air to pass through and eventually enter the flow indicator housing 324 to interact with the flow indicator 322. Therefore, the flow indicator 322 is less likely to be blocked or stuck by kidney stone fragments. In either embodiment of the flow indicator, the flow indicator should be protected from its movement being stopped by debris interacting with the flow indicator itself.

[0109] Fig.46 and Fig.4734 and 35. are two views of a flow indicator mechanism including a flow indicator 322 positioned in a flow indicator housing 324. Fluid from the stone trap container 336 enters the flow indicator housing 324 through a flow inlet 344, which is connected to an indicator inlet 346 to introduce fluid into the flow indicator housing 324 and interact with the flow indicator 322. The fluid exits the flow indicator housing 324 through an indicator outlet 348 connected to a flow outlet 350. The flow indicator 322 includes at least two flow indicator blades 352 that interact with the fluid as it moves from the indicator inlet 346 to the indicator outlet 348. The movement of the fluid between the indicator inlet 346 and the indicator outlet 348 pushes the flow indicator blades 352 and produces movement of the flow indicator 322 by causing the flow indicator 322 to rotate about the axle 330. The indicator inlet 346 and the indicator outlet 348 may both be positioned in the flow indicator housing 324 and at different locations such that the fluid flow interacts with one or more flow indicator vanes 352 on the path between the indicator inlet 346 to the indicator outlet 350 .

[0110] The flow indicator embodiments disclosed herein are a method of preventing overpressure in a device and / or anatomical structure during a kidney stone removal procedure. In addition to or in lieu of a flow indicator, the mechanisms and devices disclosed herein may include a pressure relief valve that is capable of releasing fluid pressure when the fluid pressure exceeds a predetermined safety threshold. The pressure relief valve may be included on a mechanism handle, on a catheter, at a connection between a handle and a catheter, on a fluid supply line, and / or at a connection between a fluid supply line and a handle.

[0111] Distal assembly and nozzle

[0112] Refer again Figure 1 , the distal assembly 16 of the insertable treatment system 10 is flexible and steerable, configured to apply irrigation, configured to allow drainage of irrigation fluid, configured to apply suction (which may be referred to as vacuum and / or suction), and includes visualization capabilities, such as at least one image sensor and at least one light emitting diode (LED). The catheter 14 includes one or more lumens and / or other elongated structures within the catheter shaft to facilitate operation of the distal assembly 16. For example, the catheter 14 may include portions of a steering assembly, such as one or more pull wires. The catheter 14 may include one or more vacuum lumens in fluid connection with the handle 12 to facilitate suction from the distal assembly 16. The catheter 14 may include one or more irrigation lumens in fluid connection with the handle 12 to facilitate irrigation from the distal assembly 16. In addition, these elongated structures may extend along the entire length of the catheter 14 or along a portion of the length of the catheter 14.

[0113] See also Fig.48A and Fig.48B , which respectively show perspective views of a distal assembly 400, which is a portion of a distal segment of the insertable treatment system 10. Fig.48A compared to, Fig.48B A view of the distal assembly 400 is shown with the outer member 402 retracted. The outer member 402 can be one or more layers of a tubular structure, and the one or more layers of the tubular structure can be part of the outer portion of the proximal segment of the catheter shaft. The layers of the outer member 402 can include a relatively soft and more flexible outer layer located on a relatively hard inner layer. The distal assembly 400 includes a vacuum lumen 404 defined by a vacuum shaft portion 406. The distal end of the vacuum shaft portion 406 terminates at or near the distal end of a nozzle tip 408. The nozzle tip 408 includes one or more irrigation ports 410 and 412. The irrigation ports 410 and 412 each have a slotted shape and can direct irrigation fluid forward and laterally from the distal end of the nozzle tip 408. The distal assembly further includes an image sensor 414 and light sources 416 located on both sides of the image sensor 414. The image sensor 414 can be a semiconductor chip designed for image capture, and the light source 416 can be a light emitting diode or similar light source. The area around image sensor 414 and light source 416 may be filled with the type of potting material commonly used for electronic devices, provided that the material is biocompatible or otherwise suitable for use with medical devices. Fig.48B A printed circuit board 418 is shown connected to the image sensor 414 and the light source 416. The area around the printed circuit board 418 may also be filled with a potting material. Fig.48B Also shown is the distal end of a pull wire 420 that can be used to manipulate the distal assembly 16 of the insertable treatment system 10. The nozzle tip 408 includes a groove into which a ferrule or similar fitting at the end of the pull wire 420 can be inserted to provide a distal attachment point for the pull wire 420.

[0114] Fig.49A A perspective view of various components of distal assembly 400 is shown, and Fig.49B Shows Fig.49A4. A perspective, exploded view of the components shown. The nozzle tip 408 is configured to receive a distal manifold 422 within the interior of the nozzle tip 408. The distal manifold 422 includes a conduit 424, although other embodiments of the distal manifold 422 may include a greater or lesser total number of conduits. The conduit 424 is used to direct irrigation fluid to the irrigation ports 410 and 412. The distal manifold 422 also includes an upper recess 426 for accommodating an imaging assembly (or components thereof), including, but not limited to, at least one printed circuit board 418, at least one light source 416, and at least one image sensor 414. The distal manifold 422 also includes a proximal flange 428 that provides a structural member to connect and seal the nozzle tip 408 on one side and the shaft manifold 430 on the other side. The seals on both sides of the proximal flange 428 may be fluid-tight. The distal manifold 422 also includes a pull wire groove 432 for connecting the steering pull wire to the distal assembly 16 to facilitate steering of the insertable treatment system 10. Fig.49B A shaft manifold 430 is shown, which includes a pull wire lumen 434 and a plurality of irrigation lumens 436 ( Fig.49B Only one of the five irrigation lumens 436 shown is labeled). In some embodiments of the catheter 14 shaft, the shaft manifold 430 may extend along the entire length of the catheter 14 shaft or only along a portion of the length of the catheter 14 shaft. In some embodiments of the catheter 14, there is no shaft manifold and the lumen defined by the outer member 402 is used as an irrigation lumen as well as as a path for a steering mechanism (e.g., a pull wire).

[0115] Fig.50A , Fig.50B and Fig.50C End views of the various components of distal tip assembly 400 are shown separately. Fig.50A The apparatus is shown having two pull-wire lumens 434 and a plurality of perfusion lumens 436 ( Figure 4 A shows a shaft manifold 430 of which only one of the five perfusion lumens 436 is labeled. Fig.50B The distal manifold 422 is shown having a conduit 424, an upper groove 426, a proximal flange 428, and a pull wire groove 432. Fig.50C A nozzle tip 408 having priming ports 410 and 412 is shown.

[0116] Fig.51A and Fig.51B Two different embodiments of nozzle tip 408 are shown. Fig.51AAn embodiment of a nozzle tip 408 is shown in which an image sensor 414 and a light source 416 are both mounted on the nozzle tip 408, and there are multiple irrigation ports 410 and 412. This embodiment is conceptually similar to the embodiments shown in the previous figures. The nozzle tip 408 includes a nozzle lumen 438, which in some embodiments can accommodate the vacuum shaft portion 406, and in alternative embodiments, the nozzle lumen 438 can define the vacuum lumen 404. Fig.51B An alternative embodiment is shown in which both the image sensor 414 and the light source 416 are mounted on an elongated insertable member 440 that is slidable relative to the nozzle tip 408, the distal assembly 400, the catheter 14 shaft, and / or the insertable system 10. The elongated insertable member 440 includes a working lumen 442 through which a therapeutic or diagnostic device can slide relative to the elongated insertable member 440. Examples of such devices include, but are not limited to, lasers, sensors, and graspers. In addition, the working lumen 442 can allow for aspiration of fluids and kidney stone fragments while the elongated insertable member 440 is in place. The outer diameter of the elongated insertable member 440 can be about 1 mm to about 4 mm, and the inner diameter of the working lumen 442 can be about 0.3 mm to about 1.5 mm.

[0117] Fig.52A and Fig.52B An alternative embodiment of a nozzle tip 408 is shown. Fig.52A In FIG. 4 , the nozzle tip 408 includes a single image sensor 414 and a single light source 416, while in Fig.52B , the nozzle tip 408 includes a single image sensor 414 and three light sources 416 (only one light source 416 is labeled). Fig.52B The arrangement of light sources 416 shown may be preferred in certain embodiments because it may provide more uniform illumination because light sources 416 are located on both sides of image sensor 414 . Fig.52A and Fig.52B Six irrigation ports 410 are shown (only one irrigation port 410 is labeled). The irrigation ports 410 are configured to direct fluid distally and laterally from the nozzle tip 408. Fig.52A and Fig.52B , the nozzle tip 408 includes a nozzle lumen 438 , which may receive the vacuum shaft portion 406 in some embodiments and may define the vacuum lumen 404 in alternative embodiments.

[0118] Fig.53A and Fig.53B An alternative embodiment of a nozzle tip 408 is shown. Fig.53A and Fig.53B, the nozzle tip 408 includes a nozzle lumen 438, which in some embodiments can accommodate the vacuum shaft portion 406, and in alternative embodiments, the nozzle lumen 438 can define the vacuum lumen 404. The nozzle tip 408 also includes at least one pull wire groove 444. The nozzle tip 408 includes a tip manifold 446, which is configured to direct fluid to the irrigation port. The tip manifold 446 is in fluid communication with one or more irrigation lumens, which direct irrigation fluid from the handle 12 and down the catheter 14 and provide a fluid path for each irrigation port. Fig.53A and Fig.53B , the nozzle lumen 438 is offset from the center of the nozzle tip 408. Fig.53A Slot-shaped irrigation ports 448 and 450 are shown. Irrigation port 448 is larger than irrigation port 450. The interior of each of irrigation ports 448 and 450 is configured to direct fluid radially away from the central axis of nozzle tip 408. Fig.53B Circular irrigation ports 452 and 454 are shown, which are similar in size. Irrigation ports 452 are both located on the front face of nozzle tip 408. The openings of irrigation ports 454 are both located on the front face of nozzle tip 408 and extend into the lateral sidewalls of nozzle tip 408. The interior of each of irrigation ports 452 and 454 is configured to direct fluid radially away from the central axis of nozzle tip 408. The configuration of irrigation port 454 causes irrigation port 454 to direct fluid more radially outward than port 452. In some embodiments, in both the slotted and circular embodiments, the direction of the fluid may approximate a spiral away from the central axis of nozzle tip 408.

[0119] Fig.54A and Fig.54B Alternative embodiments of nozzle tip 408 are shown separately. Fig.54A and Fig.54B , the nozzle tip 408 includes a nozzle lumen 438, which in some embodiments can accommodate the vacuum shaft portion 406, and in alternative embodiments can define the vacuum lumen 404. The nozzle tip 408 also includes at least one pull wire groove 444. The nozzle tip 408 includes a tip manifold 446, which is configured to direct fluid to the irrigation ports. The tip manifold 446 is in fluid communication with one or more irrigation conduits 456 to provide a fluid path to each irrigation port. Fig.54A and Fig.54B , the nozzle lumen 438 is concentric with the outer diameter of the nozzle tip 408. Fig.54A Six circular irrigation ports 458 are shown. The irrigation ports 458 may be oval, slotted, or arcuate in shape. The openings of the irrigation ports 458 extend from the front face of the nozzle tip 408 into the lateral sidewalls thereof. Fig.54BFive circular irrigation ports 458 are shown that are similar in size. The interior of each irrigation port 458 is configured to direct fluid radially away from the central axis of the nozzle tip 408. Fig.54A and Fig.54B The exit angle of the irrigation port is shown to be approximately 45 degrees relative to the central axis of the nozzle tip 408 , and the direction of irrigation fluid away from the nozzle tip 408 is radially away from the central axis of the nozzle tip 408 .

[0120] Fig.55A and Fig.55B Alternative embodiments of nozzle tip 408 are shown separately. Fig.55A and Fig.55B , the nozzle tip 408 includes a nozzle lumen 438, which in some embodiments can accommodate the vacuum shaft portion 406, and in alternative embodiments, the nozzle lumen 438 can define the vacuum lumen 404. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull wire groove 444. The nozzle tip 408 includes a tip manifold 446, which is configured to direct fluid to the irrigation port. The tip manifold 446 is in fluid communication with one or more irrigation lumens, which direct irrigation fluid from the handle 12 and down the catheter 14, and provide a fluid path for each irrigation port. Fig.55A There are shown three circular irrigation ports 458, which have an exit angle of about 45 degrees and are configured to direct fluid radially away from the central axis of the nozzle tip 408, and two elliptical irrigation ports 460, which each direct fluid to flow downward from the central axis of the nozzle tip 408 at a 45 degree angle, but not in a radially divergent direction. The openings of the elliptical irrigation ports 460 are each located on the front face of the nozzle tip 408. The openings of the circular irrigation ports 458 surround both the front face and the side wall. Fig.55B Five circular injection ports 458 are shown, each having an exit angle of approximately 45 degrees and configured to direct fluid radially away from the central axis of the nozzle tip 408; and two elliptical injection ports 460, each directing fluid to flow downward from the central axis of the nozzle tip at a 45 degree angle, but not in a radially divergent direction.

[0121] Fig.56 A rear perspective view of a nozzle tip 408 (e.g., which may be any of the nozzle tips described) is shown, wherein a tip manifold 446 provides a fluid path for various irrigation ports on the distal face of the nozzle tip 408. The nozzle tip 408 also includes a nozzle irrigation lumen 462 that provides a path for fluid from the catheter 14 to the tip manifold 446.

[0122] Fig.57An alternative embodiment of the nozzle tip 408 is shown. The nozzle tip 408 includes a nozzle lumen 438, which in some embodiments can accommodate the vacuum shaft portion 406, and in alternative embodiments, the nozzle lumen 438 can define the vacuum lumen 404. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull wire groove 444. The nozzle tip 408 includes a tip manifold 446, which is configured to direct fluid to the irrigation port. The tip manifold 446 is in fluid communication with one or more irrigation lumens, which direct irrigation fluid from the handle 12 and down the catheter 14 and provide a fluid path to each irrigation port. Fig.57 A slotted irrigation port 464 is shown having an exit angle of approximately 45 degrees and configured to direct fluid radially away from the central axis of the nozzle tip 408. The irrigation port 464 has an arc of 140 degrees, which provides a large amount of fluid sweep. The nozzle tip 408 includes two oval irrigation ports 466, each of which directs fluid flow downward from the central axis of the nozzle tip at a 45 degree angle, but not in a radially divergent direction.

[0123] Fig.58A and Fig.58B Alternative embodiments of nozzle tip 408 are shown separately. Fig.58A and Fig.58B , the nozzle tip 408 includes a nozzle lumen 438, which in some embodiments can accommodate the vacuum shaft portion 406, and in alternative embodiments, the nozzle lumen 438 can define the vacuum lumen 404. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull wire groove 444. The nozzle tip 408 includes a tip manifold 446, which is configured to direct fluid to the irrigation port. The tip manifold 446 is in fluid communication with one or more irrigation lumens, which direct irrigation fluid from the handle 12 and down the catheter 14 and provide a fluid path to each irrigation port. Fig.58A Two slotted irrigation ports 468 are shown, each having an exit angle of about 45 degrees and configured to direct fluid radially away from the central axis of the nozzle tip 468. Each irrigation port has an arc of about 70 degrees and is separated by a central region having an arc of about 40 degrees. Together, the irrigation ports 468 can provide a fluid sweep of about 180 degrees. Fig.58B Two slotted irrigation ports 470 are shown, each having an exit angle of approximately 65 degrees and configured to direct fluid radially away from the central axis of the nozzle tip 408. Each irrigation port 470 has an arc of approximately 70 degrees, and the irrigation ports 470 are separated by a central region having an arc of approximately 40 degrees. Together, the irrigation ports 470 can provide a fluid sweep of approximately 180 degrees. Fig.58A and Fig.58BIrrigation ports 468 and 470 are shown, each configured to direct fluid distally and laterally from the distal end of nozzle tip 408 .

[0124] Fig.59A and Fig.59B Alternative embodiments of nozzle tip 408 are shown separately. Fig.59A and Fig.59B , the nozzle tip 408 includes a nozzle lumen 438, which in some embodiments can accommodate the vacuum shaft portion 406, and in alternative embodiments, the nozzle lumen 438 can define the vacuum lumen 404. The nozzle lumen 438 is offset from the center of the nozzle tip 408. The nozzle tip 408 also includes at least one pull wire groove 444. The nozzle tip 408 includes a tip manifold 446, which is configured to direct fluid to the irrigation port. The tip manifold 446 is in fluid communication with one or more irrigation lumens, which direct irrigation fluid from the handle 12 and down the catheter 14, and provide a fluid path for each irrigation port. Fig.59A Two slotted irrigation ports 472 are shown, each having an exit angle of approximately 45 degrees and configured to direct fluid radially away from the central axis of the nozzle tip 408. The arc of each irrigation port 472 is approximately 70 degrees, and the irrigation ports 472 are separated by a central region having an arc of approximately 40 degrees. Together, the irrigation ports 472 can provide a fluid sweep of approximately 180 degrees. Fig.59A Irrigation ports 472 are shown, each configured to direct fluid distally and laterally from the distal end of the nozzle tip 408 . Fig.59B Four slotted irrigation ports 474 and 476 are shown, each having an exit angle of approximately 45 degrees and configured to direct fluid radially away from the central axis of the nozzle tip 408. Each irrigation port has an arc of approximately 20 degrees. The irrigation ports 474 are separated by a central region having an arc of approximately 50 degrees. Adjacent irrigation ports 474 and 476 are separated by a region having an arc of approximately 40 degrees. The irrigation ports 474 and 476 together can provide a fluid sweep of approximately 180 degrees. Fig.59A and Fig.59B Irrigation ports are shown, each configured to direct fluid distally and laterally from the distal end of the nozzle tip 408 .

[0125] The various embodiments of the irrigation port configurations presented in the present invention show that the nozzle tip can achieve various spray patterns by manipulating variables such as the size, shape and number of irrigation ports, the outlet angle of the irrigation ports, the location of the irrigation ports on the distal face of the nozzle tip (i.e., completely on the distal face, or partially on the distal face and partially on the side of the nozzle tip as shown in the figure). In addition, one or more irrigation ports can be configured to be the same or different from the configuration of one or more irrigation ports on the same nozzle tip.

[0126] Fig.60 and Fig.61 4 and 5. Each is a perspective view of an embodiment of a distal assembly 400 positioned in a distal section of an insertable treatment system 10. Fig.60 and Fig.61 4 and 5 show an outer member or outer hypotube 402 included in the distal assembly 400. As disclosed herein, the outer member 402 of the distal assembly 400 may include one or more tubular structural layers. Fig.60 and Fig.61 In the embodiment of the present invention, the outer hypotube 402 may be at least partially covered by a more flexible outer layer (not shown). Fig.60 and Fig.61 A vacuum lumen 404 defined by a nozzle tip 408 in the distal assembly 400 is shown, as well as a vacuum lumen 404 defined by a vacuum shaft portion (not shown) in the portion of the device proximal to the distal assembly 400 . Fig.60 and Fig.61 The nozzle tip 408 shown includes an angled distal face to reduce the distal-most surface area of ​​the nozzle tip 408, which can reduce the possibility of trauma to tissue as the device is advanced distally. The reason why the edges of the distal face are rounded or curved smoothly compared to sharp corners is also to reduce the possibility of trauma. Such angled distal faces or rounded and smooth edges can be achieved using any of the above-described nozzle tip 408 configurations. The nozzle tip 408 is shown to include four irrigation ports, which are arranged in two pairs, namely a pair of upper irrigation ports 412 and a pair of lower irrigation ports 410, but in Fig.60 and Fig.61 , only one of each pair of irrigation ports is visible. The paired irrigation ports 410 and 412 each have a slotted shape and can direct irrigation fluid forward and laterally from the distal end of the nozzle tip 150. An image sensor 414 is disposed on the nozzle tip 408, and a light source 416 can be located on both sides of the image sensor 414. As with the previous embodiment, the image sensor 414 can be a semiconductor chip designed for image capture, and the light source 416 can be a light emitting diode or similar light source. The area around the image sensor 414 and the light source 416 can be filled with a potting material commonly used for electronic devices, provided that the material is biocompatible or otherwise suitable for use with a medical device.

[0127] Fig.62A and Fig.62BA perspective view and a side view, respectively, are shown of an embodiment of a nozzle tip 408 of the distal assembly 400. The nozzle tip 408 includes a pair of upper irrigation ports 412 and a pair of lower irrigation ports 410 disposed around the vacuum lumen 404. The nozzle tip 408 includes an upper recess 478 that provides a location for mounting an image sensor and a light source. Fig.62B The angled distal face of the nozzle tip 408 is shown. The nozzle tip 408 includes two conduits 480, one on each side of the nozzle tip 408, which provide a fluid path between the irrigation ports 410 and 412 and the irrigation lumen in the catheter shaft segment. The nozzle tip 408 may include multiple conduits 480. Fig.62A and Fig.62B In the illustrated embodiment, each conduit 480 includes a divider 482 that helps direct fluid to each irrigation port 410 and 412. Depending on the number of irrigation ports in the nozzle tip, there may be multiple dividers in the conduit to distribute the fluid to the irrigation ports. The size of the divider affects the flow characteristics of the irrigation fluid at each irrigation port and can be varied to achieve the desired flow characteristics at each port.

[0128] Fig.62C An end view of the nozzle tip 408 is shown, showing an upper irrigation port 412 and a lower irrigation port 410, each of which includes an opening facing forward. As described herein, the interior of the irrigation ports 410 and 412 can be angled so that the irrigation fluid leaves the nozzle tip at a departure angle relative to the central axis of the nozzle tip, as described herein. The irrigation ports 410 and 412 can each be characterized by parameters such as their shape, their radial distribution, their departure angle, and their forward facing area.

[0129] In some embodiments of the nozzle (e.g., any of the nozzle tips 408 described above), the radial distribution of the irrigation ports is such that the irrigation ports are substantially evenly distributed around the circumference of the nozzle. In some embodiments (e.g., any of the nozzles 408 described above), in a cross-sectional view of the nozzle tip, the maximum angle between any two adjacent irrigation ports measured from the center to the center of each irrigation port is less than about 110 degrees, and depends on the number of irrigation ports on the nozzle. For more than three irrigation ports, there may be a pair of adjacent irrigation ports for which the angle measured from the center to the center of each irrigation port is approximately about 110 degrees, and several other irrigation ports have angles measured from the center to the center of each irrigation port that are approximately less than about 110 degrees.

[0130] In some embodiments of the nozzle (e.g., any of the nozzle tips 408 described above), the irrigation port has a main axis that is angled relative to the central longitudinal axis of the nozzle. The angle or nozzle outlet angle can range from about 30 degrees to about 60 degrees and can be referred to as the irrigation port departure angle. The nozzle can be configured to have irrigation ports that have different departure angles or the same departure angle as other irrigation ports on the same nozzle. The irrigation port group can have the same departure angle, and the angle can be different from another group of irrigation ports on the same nozzle. In some preferred embodiments, the irrigation port departure angle is about 45 degrees. In other preferred embodiments, the injection port departure angle is 30 degrees, 31 degrees, 32 degrees, 33 degrees, 34 degrees, 35 degrees, 36 degrees, 37 degrees, 38 degrees, 39 degrees, 40 degrees, 41 degrees, 42 degrees, 43 degrees, 44 degrees, 45 degrees, 46 degrees, 47 degrees, 48 ​​degrees, 49 degrees, 50 degrees, 51 degrees, 52 degrees, 53 degrees, 54 degrees, 55 degrees, 56 degrees, 57 degrees, 58 degrees, 59 degrees, or 60 degrees. In a preferred embodiment, there is a set of injection ports with a departure angle of 34 degrees and another set of injection ports with a departure angle of 50 degrees on a nozzle. Table 1 shows the departure angles of the injection port pairs for several different nozzle designs.

[0131] Table 1: Departure angles of injection ports for some nozzle designs

[0132] design Top port angle (degrees) Bottom port angle (degrees) L1 39.15 41.75 L2 35.05 38.45 L3 26.8 38.35 L4 22.4 39.9 L5 33.25 53.45 K1 45 45 K2 45 45 K3 45 45 K4 45 45 K5 45 45 K6 45 45

[0133] The hydraulic diameter is a useful parameter for characterizing various injection port configurations. In general, the hydraulic diameter is used to characterize flow in non-circular channels in the common flow calculation methods for circular channels. If the cross section is uniform along the length of the channel, then the hydraulic diameter D H Defined as: Where A is the cross-sectional area of ​​the flow and P is the wetted perimeter of the cross section.

[0134] To characterize the preferred embodiment of the nozzle tip design, several nozzle tips were made. The nozzle tip includes two pairs of injection ports, where the top and bottom (i.e., upper and lower) are symmetrical pairs with the same slot shape and departure angle. Table 2 shows the relevant dimensions of several different nozzle designs. The table shows the area and perimeter of each individual port in a pair of injection ports.

[0135] Table 2: Injection port dimensions for some nozzle designs

[0136]

[0137] The test specimen was constructed using a representative vacuum lumen and camera wire to approximate the pressure drop and flow characteristics of the fully constructed device.

[0138] The flow rate can be determined by measuring the amount of water flowing out of the nozzle over time. The experimental apparatus includes a conventional saline irrigation bag at a certain pressure (e.g., 2psi or 4psi) connected to the catheter and nozzle segment of the apparatus. Table 3 shows the flow rate test results (in grams per second) for several nozzle arrangements.

[0139] Table 3: Mass flow rates for some nozzle designs

[0140]

[0141]

[0142] According to empirical analysis of a series of nozzle designs including multiple irrigation ports, the preferred minimum irrigation mass flow rate of the saline bag at 2psi is about 0.55g / s, and the preferred minimum irrigation mass flow rate of the saline bag at 4psi is about 0.75g / s. In the nozzle, each irrigation port contributes 1 / N of the total mass flow rate, where N is the number of irrigation ports, and this fraction can be converted to a percentage. Through empirical analysis of a series of nozzle designs with 4 irrigation ports, the measured results show that the contribution rate of each irrigation port to the total irrigation mass flow rate is between 15%-30%, while the calculated result is 25%. In some embodiments of the nozzle, the irrigation mass flow rate from each irrigation port is substantially the same. In other embodiments of the nozzle, the irrigation mass flow rate from some irrigation ports may be 2 to 4 times greater than the irrigation mass flow rate of other irrigation ports. This asymmetry can be advantageously used to provide high irrigation mass flow rates from the nozzle in certain directions.

[0143] The areas affected by nozzle design can be determined empirically. Fig.63A A test device 484 for determining the affected area is shown, which includes a flat test surface 486 with a grid pattern on which a test bench kidney stone fragment 488 or simulated kidney stone fragment is scattered, and the size range of the kidney stone fragment 488 or simulated kidney stone fragment is about 1.8mm to 2.0mm. The preferred test device includes a test bench kidney stone fragment with substantially uniform size. The test device includes a mount 490 for aligning the distal end of the device including the nozzle 408 at a fixed distance above and parallel to a test bench kidney stone on the grid pattern. Using a pressurized saline bag, the perfusion fluid is delivered through the nozzle for a certain time, and the area affected by the fluid ejected from the nozzle is calculated using the grid pattern. The pressure on the saline bag can range from about 0.5psi to about 6.0psi. In some preferred embodiments, the pressure on the saline bag is 2psi or 4psi. The nozzle is then rotated a fixed amount about its longitudinal axis, the test is repeated, and the area affected by the fluid is calculated. Fig.63BA top view of the test station after a test run is shown. Areas free of kidney stone fragments can be seen on the surface and the area of ​​the areas can be determined using the grid pattern on the surface.

[0144] In a preferred test embodiment, the nozzle was rotated 90 degrees so that four test runs were able to approximate the three-dimensional volume affected by the placement of the injection ports on the nozzle. In addition, the distance of the nozzle above the grid surface can be changed to approximate a larger or smaller three-dimensional volume. In some preferred embodiments, the distance from the nozzle to the grid surface is about 6 mm. Table 4 shows the test results of the affected area area for several nozzle arrangements (unit: mm 2 ).

[0145] Table 4: Affected area for some nozzle designs

[0146]

[0147] The mesh surface test bed approximates an open and effectively infinitely large volume compared to an anatomical scale cavity.Another test method can be used to approximate a closed system such as the renal pelvis or calyx.

[0148] In one embodiment of a closed system test apparatus, kidney stone fragments or simulated kidney stone fragments ranging in size from about 1.8 mm to 2.0 mm are placed in a test tube. The length and diameter of the test tube define the volume of the test chamber. For example, a test tube with a diameter of 14 mm and a length of 100 mm can approximate a closed environment with anatomically relevant dimensions. The test apparatus includes a fixture or mounting member for aligning the distal end of a device including a nozzle concentrically with the cross section of the test tube. When the perfusion fluid is applied at a given pressure, the distal end of the nozzle can advance and retract relative to the end of the test tube. The extent to which the kidney stone fragments move with distance is determined. Table 5 shows the results of the closed environment test, and the distances shown in the table reflect the maximum distance that the nozzle design can move the stone fragments in the test apparatus when the perfusion fluid is supplied at a pressure of 2 psi.

[0149] Table 5: Fluidization distances for some nozzle designs

[0150]

[0151]

[0152] Empirical testing of various nozzle configurations disclosed herein has demonstrated some preferred performance characteristics for various aspects of the method for fluidizing kidney stone fragments. In some preferred embodiments, when the applied pressure is 2 psi, the fluid velocity is in the range of about 0.50 m / s to about 1.50 m / s, and preferably at least about 1.00 m / s. In other preferred embodiments, when the applied pressure is 4 psi, the fluid velocity is in the range of about 0.9 m / s to about 2.00 m / s, and preferably at least about 1.45 m / s.

[0153] Fig.64 A cross-sectional view of a portion of the catheter 14 is shown. The outer member of the catheter 14 includes an outer sheath 492 and an outer hypotube 494. A pull wire 496 is provided within the outer member, and the pull wire 496 is located within the pull wire hypotube 498 so that the pull wire 496 can slide freely longitudinally relative to the pull wire hypotube 498. In some embodiments, the pull wire hypotube 498 can be fixed against the outer member and fixed on opposite sides of the outer member. In other embodiments, the pull wire hypotube 498 is only fixed to the distal end of the catheter 14. The cable 500 is also located within the outer member and connects the image sensor in the distal assembly to the handle. The cable 500 can move freely within the outer member, but is fixed within the outer member at its distal and proximal ends or near its distal and proximal ends. The vacuum shaft portion 502 surrounding the vacuum lumen 504 is also located within the outer member and connects the vacuum lumen 504 defined by the nozzle tip to the handle 12. The vacuum shaft 502 can also move freely in the outer member, but is fixed in the outer member at its distal and proximal ends or near its distal and proximal ends. The remaining space in the outer member that is not occupied by the pull-line hypotube 498, the cable 500, or the vacuum shaft 502 is the perfusion space 506, through which the perfusion fluid can flow from the handle to the pipe in the distal assembly. Since the cable 500 and the vacuum shaft 502 can both move freely in the outer member, the perfusion space 506 is not a fixed shape. An advantage of this arrangement is that there is no dedicated perfusion shaft, thereby reducing the number of structures in the catheter shaft assembly 14. Fewer structures make the catheter shaft assembly easier to manufacture and more flexible. For example, when the catheter shaft is generally straight, the perfusion space can present a general annular shape between the outer member and the vacuum shaft, but when the catheter shaft is curved, the perfusion space can present a general crescent shape because the vacuum shaft is pressed against the inner wall of the outer member.

[0154] Tool guide

[0155] The above-mentioned advances in catheter technology have enabled us to integrate the camera, laser, aspiration and irrigation components into a single system, thereby simplifying the kidney stone removal procedure and reducing the likelihood of adverse consequences associated with kidney stone treatment procedures, especially the need for repeated insertion and removal of the ureteroscope and extraction catheter to remove all stones. However, one challenge faced by catheter systems is the inability to maintain an appropriate catheter diameter. The integration of components, especially the integration of the laser, requires additional channels, which can make the profile of the catheter larger than desired. Larger diameter catheters can cause more tissue irritation and damage when guided through the ureter, renal pelvis and calyces. In some embodiments, due to ureteral narrowness and / or tortuosity, large diameter catheters may not be able to enter the kidney at all. Therefore, in order to maintain a low profile of the catheter, an existing lumen, such as a vacuum lumen (described above), can be used for the laser and other tools. The use of a vacuum lumen is feasible because it is wide enough to accommodate the laser. The diameter of the laser fiber is smaller than the vacuum lumen (the diameter of the vacuum lumen is much larger than the diameter of the working channel of a conventional ureteroscope that receives the laser device). However, this significant difference in diameter allows the laser fiber to move within the vacuum lumen. Unnecessary movement of the laser fiber prevents the clinician from accurately targeting the stone. Any side-to-side movement of the laser fiber within the vacuum lumen not only makes the stone difficult to fragment, but also increases the risk of laser damage to nearby tissue. Embodiments of the tool guide provide a tool, among other things, for enabling the laser to be used effectively with an extraction catheter system to fragment kidney stones while allowing the stone to flow past the laser and through the vacuum lumen.

[0156] The vacuum lumen of the catheter and nozzle (e.g., lumen 404 and 504 as described above) can be used to insert and retract a stone fragmentation inducing device, such as a lithotripsy device, or most preferably a laser lithotripsy device. The inner diameter of the inner tube or the diameter of the vacuum lumen (e.g., 404 and 504) needs to be large enough to accommodate a large amount of broken stones passing through without clogging. In an embodiment of the present invention, the diameter of the vacuum lumen (e.g., 404 and 504) can be, for example, 2.0 mm to 3.0 mm, or about 2.5 mm in some configurations. However, the diameter of the laser fiber and the lithotripsy device are much smaller than the diameter of the vacuum lumen. This significant difference in diameter causes the fragmentation inducing device to move around or shift within the vacuum lumen during operation. Unexpected movement of the laser makes it difficult for the doctor to accurately aim at the stone.

[0157] Thus, embodiments of the present invention provide an intermediate device for securing a fragmentation-inducing device, preferably a laser device or an optical fiber, into a vacuum lumen, such as, for example, 404 and 504. The intermediate device is configured to completely prevent or significantly minimize movement of the laser fiber at the distal end of the vacuum lumen, while not impeding the function of the vacuum lumen and allowing fluids and solids to flow through the laser fiber. Fig.65The intermediate device, referred to herein as guide 508, is shown. Guide 508 includes an elongated body or tube 510 configured to be inserted through the working channel (e.g., ports 42 and 138) of handle 12 and through the proximal end of catheter 14 and pushed through a vacuum lumen (e.g., vacuum lumens 404 and 504) until the distal end of guide 508 is precisely positioned at or substantially adjacent to the distal end of the vacuum lumen (e.g., at the end of distal assembly 400 and nozzle tip 408). In one embodiment, the length of guide 508 is equal to the length of the vacuum lumen in which it is placed. Preferably, guide 508 is configured such that when guide 508 is fully placed within the vacuum lumen or in an operating position (i.e., holding the laser tip at the distal end of vacuum lumen 404 (or nozzle tip 408)), the distal tip of guide 508 does not extend beyond the distal opening of vacuum lumen 404 (or nozzle tip 408). The guide 508 includes at least two wings, ridges, flanges, or extensions 512, which are used interchangeably in the present invention. The wings 512 protrude or extend from the distal section of the elongated body 510. In one embodiment, the wings 512 extend from the distal section of the elongated body 510 so that when the elongated body 510 is placed in its operating position within the vacuum lumen 404, the wings 510 are located at the most distal section of the vacuum lumen 404 of the nozzle tip 408. The wings 510 can be an integral extension of the elongated body 510-this means that the body 510 and the wings 512 are made or molded from one piece. Alternatively, the wings 512 can be an extension of a smaller tube that is disposed above the distal section of the elongated body 510 and attached thereto. A lumen 514 extends through the center of the elongated body 510 for receiving a fragmentation inducing device, preferably a laser fiber. The lumen 514 has a diameter for accommodating the laser fiber used. In other words, the diameter of lumen 514 is large enough to allow the laser fiber to be freely inserted and retracted therefrom, but small enough to prevent or significantly minimize any non-rotational or side-to-side movement of the laser fiber. The distal-most end of guide 508 (forward of wing 512) may include knob section 516 having a tapered end with a smaller diameter than elongated body 510. Knob section 516 facilitates insertion of guide 508 into the access port of handle 12 and vacuum lumen (e.g., 404 and 504). The vacuum lumen (e.g., 404 and 504) of nozzle tip 408 may include a tapered section (not shown). Knob section 516 may contact against this smaller tapered end of nozzle tip 408 to act as a stopper and prevent guide 508 from extending from vacuum lumen 404.

[0158] Fig.66A front end view of an embodiment of a guide 508 is shown. The guide includes (or consists of) two wings 512a and 512b extending from an elongated body 510. The dimensions of the wings 512a and 512b allow the guide 508 to slide freely into and out of a vacuum lumen (e.g., lumens 404 and 504, and a nozzle lumen, such as lumen 438) while preventing the wing-shaped segments of the guide 508 from side-to-side or non-rotational movement within the vacuum lumen (and nozzle lumen). In other words, the maximum diameter D of the guide 508 (including the width (i.e., height) of the wings 512) should be slightly smaller than the inner diameter of the vacuum lumen to allow the wings 512 to pass through the vacuum lumen while preventing significant side-to-side movement of the wings 512 within the vacuum lumen. In one embodiment, the diameter D may match or be approximately equal to the inner diameter of the vacuum lumen (e.g., Fig.48A and Fig.48B In this case, the wings 512 may be made of a softer or more flexible plastic material so that the wings 512 compress slightly when installed through the vacuum lumen.

[0159] Although Fig.66 A preferred two-wing design is shown, but the guide 508 may include (or consist of): 3 wings 512 or 4 wings 512. Although embodiments of the present invention may include any number of wings, a 2 to 4 wing design is preferred because a greater number of wings may cause stones to block the vacuum lumen or become lodged between the vacuum lumen and the elongated body 510, thereby interfering with the function of the vacuum lumen.

[0160] Fig.67 is a generally schematic front view of a guide 508, which includes (or is composed of) the following: four wings 512a-512d, which are located on a vacuum tube 518 (or Fig.48A and Fig.48BThe distal end of the vacuum shaft portion 406 (shown) is used to fix the tip of the laser device or optical fiber at the distal tip of the vacuum tube 518. The laser device or optical fiber 520 is schematically shown to be located in the lumen 514 of the guide 508. The restricted diameter of the lumen 514, while allowing the laser fiber 520 to be inserted and retracted through the guide 508, can prevent or significantly reduce the movement of the laser fiber 520 within the vacuum tube 518 that is not intended by the physician. The stability of the laser 520 enables the physician to apply laser pulses to the kidney stone very accurately, thereby effectively fragmenting the stone while reducing the risk of injury caused by stray laser pulses. The wings 512a-512d should have a sufficient width or height (i.e., the distance between the elongated body 510 and the vacuum tube 518) to create a gap 522 between the guide 508 and the vacuum tube 518. The gap 522 allows the vacuum lumen to apply suction to remove fluid, debris, and kidney stone fragments throughout the laser surgery. The number of wings 512 determines the number of gaps 522. For example, two wings 512 provide two large gaps 522, three wings 512 provide three medium-sized gaps 522, and the illustrated configuration of four wings 512 provides four smaller gaps 522. Larger gaps 522 are preferred to minimize the possibility of stone blockage or entrapment at the entry point or along the distal section of the guide 508.

[0161] Fig.67Four wings 512a-512d are shown, wherein the circumferential distance between any two adjacent wings is the same. That is, the distance between each of 512a-512b, 512b-512c, 512c-512d, and 512d-512a is equal. In one embodiment, the circumferential distance between two adjacent wings may be different from the distance between another pair of adjacent wings (even if there is a common wing). For example, the distance between each of adjacent wings 512a-512b and 512c-512d may be the same, and the distance between each of adjacent wings 512a-512d and 512b-512c may be the same, but the distance between 512a-512b or 512d-512c is less than the distance between 512a-512d or 512b-512c. This configuration provides two small gaps 522 to allow smaller stones to pass through, and two large gaps 522 to allow larger stones to pass through, which may not be removed if the gaps 522 are the same size. In a three-wing configuration, the distance between each wing can be varied, thereby providing three gaps 522 each having a different size. Alternatively, in a three-wing configuration, the distance between two pairs of adjacent wings can be the same, while the distance between the third pair of adjacent wings is different. In some embodiments, instead of or in addition to changing the distance between the wings 512 to change the size of the gaps 522, the width of the wings (the distance between the elongated tube 510 and the vacuum lumen 518) can be varied to provide gaps 522 of different sizes. By providing wings 512 with different widths, the position of the laser head will be shifted relative to the center of the vacuum lumen. Therefore, in some embodiments, at least two gaps 522 of different sizes can be provided.

[0162] Fig.68 is an embodiment of the wing 512 design. The wing 512 includes an intermediate segment 512-1 that extends into the distal 512-2 and proximal 512-3 segments. The length of the intermediate segment 512-1 (in the x-direction, i.e., along the longitudinal axis) is greater than the length of the distal 512-2 and proximal 512-3 segments. The intermediate segment 512-1 may have a constant width (in the y-direction, i.e., along the radial axis). The intermediate segment 512-1 may have a rectangular shape, which enables it to have sufficient surface contact with the inside of the vacuum lumen to create stability and prevent any accidental displacement of the distal end of the guide 508 (where the wing 512 is located). The distal 512-2 and proximal 512-3 segments of the wing 34 are both inclined or tapered from the intermediate segment 512-1 toward the elongated tube 32. The thickness of the wing 512 (in the z-direction) may be the same along its entire span. In alternative embodiments, the thickness of the wing 512 (in the z-direction) may vary such that the wing 512 tapers in the x-direction or longitudinal direction. Fig.69AAs best shown in FIG. 5 , the wing 512 may have its thickest dimension at its distal end and its thinnest dimension at its proximal end. In one embodiment, the sidewalls of the wing 512 may converge at an angle, such as Fig.69A As shown, the wing portion 512 has an isosceles triangle shape when viewed from the top. According to another embodiment, as Fig.69B As shown, the longitudinal axis of the wing 512 is not aligned with the longitudinal x-axis of the guide 508. The longitudinal axis of the wing 512 is rotated relative to the x-axis of the guide 508. According to another embodiment (not shown), the wing 512 can have a radius of curvature along the longitudinal direction. The wing 512 can be symmetrically positioned around the elongated body or tube 510, or the wing 512 can be asymmetrically positioned around the elongated body or tube 510.

[0163] Fig.70 Another embodiment of a guide 508 is shown. The guide 508 includes a distal segment 524 configured to extend out of a vacuum lumen (e.g., lumens 404 and 438 or nozzle tip 408) when the guide 30 is in place. For example, the distal segment 524 can be a soft tip. The wings 512 are each located proximal to the distal segment 524, but are intended to be located at the distal section of the vacuum tube.

[0164] The guide 508 fixedly supports the laser fiber head at the distal tip of the vacuum lumen or nozzle tip, while allowing the vacuum lumen to aspirate stones, debris and fluids during laser surgery and accompanying kidney stone fragmentation. However, the presence of the guide 508 reduces the inner working diameter of the vacuum lumen. Therefore, the guide 508 increases the chance that larger stones will accumulate and / or become stuck at the vacuum lumen entry point and in the gap 522 or between the wings 512. Such blockages can reduce aspiration efficiency, requiring manual removal of debris or increased internal pressure. The flow indicator 322 of the handle 12 (described above) can provide feedback to the user of blockages and reduced aspiration. Therefore, a device can be used to move the guide 508 back and forth, vibrate or oscillate to clear or unblock stuck or blocked stones. Slight back and forth movement of the guide 508 can effectively remove debris and clear the vacuum lumen. According to one embodiment, as Fig.71A and Fig.71BAs shown, an actuator 526 is provided, which can be permanently attached to the guide 508 or removably coupled to the guide 508. The actuator 526 can include a biasing band 528. The biasing band 528 is a self-resetting body, so that the inward compression (i.e., squeezing) and release of the band 528 can cause the guide 508 and the wing 512 to move back and forth within the vacuum lumen (e.g., the lumens 404 and 438). One end of the shaft 530 passes through the hole 532 of the band 528. The shaft 530 can be securely fixed to the band 528 by two pairs of opposing tabs (tabs) 534 extending from the shaft 530. The cylindrical housing 536 receives the opposite ends of the shaft 530. When the band 528 is compressed and released, the shaft 530 can move back and forth in the cylindrical housing 536. The cylindrical housing 536 is coupled to the opposite side of the belt portion 528, and the shaft portion 530 is coupled to the opposite side of the belt portion 528. The shaft portion 530 may include a shaft portion head 537, which may be permanently attached to the proximal end tail of the guide 508, or the shaft portion head 537 may be configured to be removably coupled to the proximal end tail of the guide 508. For example, the shaft portion head 537 and the proximal end tail of the guide 508 may both have a female / male coupling member. The tubular member 538 may extend from the proximal end of the cylindrical housing 536. The member 538 may be configured to be connected to a handle (e.g., the handle 12 described above) of the catheter and disconnected from the handle. The entry channel 540 may extend from the member 538, the cylindrical housing 536 and the shaft portion 530 and communicate with the lumen 514 of the guide 508. The laser fiber can be inserted into the entrance opening of the entry channel 540, through the actuator 526, and into the lumen 514 of the guide 508. The laser fiber can be pushed through the lumen 514 of the guide 508 until the laser head reaches the distal tip of the vacuum lumen (or nozzle tip), wherein the wings 512 of the guide 508 prevent any accidental movement of the laser head.

[0165] Fig.72Another embodiment of an actuator 542 is shown. The actuator 542 can be permanently attached to the guide 508 or removably coupled to the guide 508. The actuator 542 can include a first (or as shown in the figure, oriented, upper or distal) lever 544, which is coupled to a second (or lower or proximal) lever 546 via a fulcrum rod 548. The actuator 542 is self-resetting, so that the inward compression (i.e., squeezing) and release of the levers 544 and / or 546 can move the guide 508 and the wings 512 back and forth within the vacuum lumen (e.g., lumens 404 and 428). The shaft portion 550 is coupled to the upper lever 544 and extends out of the opening of the upper lever 544. The cylindrical housing 552 receives the opposite ends of the shaft portion 550. When the levers 554 and / or 546 are compressed and released, the shaft portion 550 can move back and forth in the cylindrical housing 552. The cylindrical housing 552 is coupled to the lower lever 546. The shaft 550 includes a shaft head 554, which can be permanently attached to the proximal tail of the guide 508, or the shaft head 554 can be configured to be removably coupled to the proximal tail of the guide 508. For example, the shaft head 554 and the proximal tail of the guide 508 can both have a female / male coupling member. A tubular member 556 can extend from the proximal end of the cylindrical housing 552. The tubular member 556 can be configured to be connected to and disconnected from the handle of the catheter (e.g., the handle 12 described above). The channel 558 can be entered from the member 556 and can extend from the member 558, the cylindrical housing 552 and the shaft 550, and communicate with the lumen 514 of the guide 508. The laser fiber can be inserted into the entrance opening of the entry channel 558, pass through the actuator 542, and insert into the lumen 514 of the guide 508. The laser fiber can be pushed through the lumen 514 of the guide 508 until the laser head reaches the distal tip of the vacuum lumen or nozzle tip, wherein the wings 512 of the guide 508 prevent any accidental movement of the laser fiber head. In operation, if the actuator 542 is pressed inwardly at position P1 (e.g., the upper lever 554 and the lower lever 546 are pressed against each other), the shaft portion 550 is actuated outwardly (upward in the illustration) and away from the lower lever 546. At this point, the upper lever 544 and / or the lower lever 546 are both pivoted about the fulcrum arm 548 to form a wider gap between the levers 544 / 546 at the end of the shaft portion of the actuator 542 and a smaller gap between the levers 544 / 546 at the end marked as position P1. If the actuator 542 is pressed inward at position P2 (eg, the upper lever 554 and the lower lever 546 are pressed against each other or the upper lever 554 is pushed downward toward the lower lever 546 ), the shaft portion 550 is actuated inward (downward in the illustration) and toward the lower lever 546 .At this point, the upper lever 544 and / or the lower lever 546 are both pivoted about the fulcrum arm 548 to form a smaller gap between the levers 544 / 546 at the end of the shaft portion of the actuator 542, and a wider gap between the levers 544 / 546 at the end marked as position P1. Therefore, the movement of the shaft portion head 554 can be away from or toward the lower lever 546 based on the force applied at P1 or P2.

[0166] To treat kidney stones, a guide wire may be used to guide the catheter into the kidney. Before the catheter is inserted into the patient, the guide 508 may be inserted into the vacuum lumen. The lumen 514 of the guide 508 may be used to receive the guide wire so that the catheter is guided through the guide wire. Alternatively, the guide 508 may be inserted into the catheter at any time during the procedure, including when the catheter reaches its intended position. If the guide wire is in the lumen 514, the guide wire is removed and then the laser fiber is inserted. The laser fiber is guided through the lumen 514 of the guide 508 until the laser head reaches the end of the knob 516. The doctor may apply laser pulses to the kidney stone while aspirating debris, stones, and fluid through the catheter and nozzle vacuum lumen. If a stone is stuck at the opening of the guide 508, the actuator 526 or 542 may be used to move the guide 508 in the vacuum lumen to remove the stone. After the laser procedure, the guide 508 may be removed and the remaining unbroken stones or broken stones may be extracted using the vacuum lumen to treat the kidney stone.

[0167] Various embodiments, aspects and implementations of the kidney stone removal system disclosed in the present invention provide various advantages when used to treat kidney stones. One of the advantages is the ability to prevent or reduce the possibility of kidney overpressure during kidney stone treatment. In traditional kidney stone laser lithotripsy, irrigation fluid can be introduced during ureteroscopy and / or laser lithotripsy. In most cases, irrigation fluid can only be discharged from the kidney through the narrow space between the ureteroscope and the entry sheath. This narrow space may be further narrowed by debris such as kidney stone fragments, clots or other substances. When the flow of fluid out of the kidney is restricted by this narrow space, the continuous infusion of irrigation fluid will cause the risk of excessive kidney pressure, thereby causing sepsis and / or other complications. The kidney stone removal system disclosed in the present invention provides a larger outlet channel via a large diameter vacuum lumen. In addition, vacuum can be applied through the large diameter vacuum lumen while introducing irrigation fluid. The large diameter of the vacuum lumen combined with the ability to apply vacuum while delivering irrigation fluid greatly reduces the possibility of kidney overpressure, thereby making kidney stone removal surgery safer.

[0168] Another advantage of the kidney stone removal system disclosed in the present invention is the ability to prevent or reduce thermal damage to the kidney during laser lithotripsy. During laser lithotripsy, heat is generated in the kidney, especially when a higher power laser is used. This heat may damage the kidney and is a concern for doctors when performing laser lithotripsy. The perfusion fluid can help dissipate heat through conductive heat transfer, but as described in the present invention, if the discharge channel is relatively narrow, the perfusion fluid may also accumulate in the kidney. The kidney stone removal system disclosed in the present invention provides a larger exit channel via a large diameter vacuum lumen and is able to apply a vacuum while delivering the perfusion fluid. The kidney stone removal system disclosed in the present invention can maintain a safe temperature in the kidney by quickly removing heated perfusion fluid from the kidney during laser lithotripsy and introducing relatively cool perfusion fluid in a continuous manner. In embodiments, aspects and implementations of the kidney stone removal system including a laser guide, even when a laser fiber is used to pulverize kidney stones, the heated perfusion fluid can easily and quickly flow through the vacuum lumen, and the relatively cool perfusion fluid can easily and quickly enter the kidney through the perfusion port on the nozzle. Rapid heat transfer through the rapid introduction and removal of perfusion fluid from the kidney significantly reduces the potential for thermal damage to the kidney, making kidney stone removal surgery safer.

[0169] Another advantage of the kidney stone removal system disclosed in the present invention is the ability to improve visibility of the kidney during laser lithotripsy. In conventional laser lithotripsy, fragments of the broken kidney stone often obstruct the field of view of the imaging portion of the ureteroscope, making it difficult for the physician to see the target area within the kidney and / or the broken kidney stone. Physicians often describe a "snowball" effect during laser lithotripsy, in which fragments are ejected from the kidney stone in a random and chaotic manner, quickly filling their field of view. The kidney stone removal system disclosed in the present invention can quickly remove the fragments fluidized in the perfusion fluid from the kidney through a large diameter vacuum lumen and introduce a transparent perfusion fluid in a continuous manner during laser lithotripsy, thereby improving visibility. In embodiments, aspects and implementations of the kidney stone removal system including a laser guide, the fragments suspended or fluidized in the perfusion fluid can easily and quickly flow through the vacuum lumen even when the kidney stone is fragmented using a laser fiber. In addition, the kidney stone removal system disclosed in the present invention does not produce a random and chaotic field of view, but rather provides a predictable pattern because the fragments can move through the field of view to the vacuum lumen in a regular motion. This regular pattern makes it easier for the physician to maintain orientation based on anatomical landmarks in the field of view. In addition, because the exit passage is relatively large (compared to the narrow passage between the ureteroscope and the entry sheath), more debris can be removed and removed faster using the kidney stone removal system disclosed herein. In some cases, the large diameter vacuum lumen can produce sufficient passive outflow to greatly improve visibility even when little or no vacuum is used. The large diameter vacuum lumen, combined with the ability to apply vacuum when delivering irrigation fluids and the regular debris flow pattern, can significantly improve visibility during laser lithotripsy, thereby making kidney stone removal procedures safer, more efficient, and more effective.

[0170] Another advantage of the kidney stone removal system disclosed herein is the ability to quickly apply and remove therapeutic or diagnostic agents from the kidney during laser lithotripsy. The perfusion fluid can have chemical or biological agents applied thereto from a source bag or using a port near the system handle. The agents can be therapeutic agents, such as, but not limited to, hemostats, antibiotics, and / or lytic agents. And the agents can be diagnostic agents, such as, but not limited to, contrast agents.

[0171] Another advantage of the kidney stone removal system disclosed in the present invention is the orientation of the irrigation port relative to the distal end of the vacuum lumen. The irrigation port delivers the irrigation fluid at a departure angle relative to the central axis of the cross-section of the vacuum lumen. This angle, combined with the vacuum applied through the vacuum lumen, produces a flow pattern that affects a volume much larger than the diameter of the distal end of the device. Moreover, this flow pattern can be regular rather than turbulent, and can reduce, mitigate and / or eliminate vortices that may form when a conventional ureteroscope delivers fluid to the kidney. In addition, empirical evidence has shown that an irrigation port that delivers fluid in a straight line from the end of the ureteroscope tip to the distal end can push debris away from the distal tip, which makes the debris difficult to aspirate. In contrast, the kidney stone removal system disclosed in the present invention can bring the debris closer to the vacuum lumen by generating regular flow patterns that initially diverge from the nozzle and then return to the central axis of the nozzle at a location far from the distal end of the nozzle. The kidney stone removal system disclosed in the present invention does not need to be directly pointed at the kidney stone fragments to affect the fragments and bring them closer to the vacuum lumen. Therefore, the effective area of ​​the kidney stone removal system disclosed in the present invention is significantly larger than the area directly in front of the nozzle, and the effective area can be used to clear debris in the calyx without pointing the nozzle directly at the debris.

[0172] Another advantage of the kidney stone removal system disclosed herein is that the irrigation port can provide flow independent of the tool used within the vacuum lumen. Conventional ureteroscopes typically provide irrigation through a working channel, and this working channel is used to provide access for a laser fiber or basket. The presence of a tool within the working channel can alter the fluid dynamics and change the flow and other flow characteristics. In contrast, the kidney stone removal system disclosed herein delivers irrigation fluid via a dedicated irrigation port, so the flow characteristics are independent of the tool (if any) used within the vacuum lumen.

[0173] As used herein, connected, attached, coupled or communicated are interchangeable terms, and when the present invention refers to a feature or element being connected, attached, coupled or communicated to another feature or element, the feature or element may be directly connected to the other feature or element, or there may be intermediate features or elements. In contrast, when a feature or element is directly connected to another feature or element, there are no intermediate features or elements.

[0174] When the present invention refers to a feature or element being "on" another feature or element, the feature or element may be directly on the other feature or element, or intervening features and / or elements may also be present. In contrast, when a feature or element is referred to as being directly on another feature or element, there are no intervening features or elements.

[0175] Although the above description refers to "embodiments", any of the above features or embodiments may be used, implemented or combined with any other features or embodiments described in the present invention.

[0176] As used herein, the singular forms "a", "an", "an", and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise.

[0177] It should also be understood that the terms “include” and / or “comprises” used in this specification specify the presence of stated features, steps, operations, elements, components and / or components, but do not exclude the presence or addition of one or more other features, steps, operations, elements, components, components and / or groups thereof.

[0178] As used herein, the term “and / or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “ / ”.

[0179] For ease of description, the present invention may use spatial relative terms such as "below", "under", "lower", "above", "above", "upper" to describe the relationship between a certain element or feature and another element or feature, as shown in the figure. It should be understood that, in addition to the directions shown in the figures, these spatial relative terms are also intended to cover different directions of the device when in use or operation. For example, if the device in the figure is inverted, the elements described as "below" or "below" other elements or features will be positioned "above" or "above" the other elements or features. Therefore, the exemplary term "below" can cover both the directions of above and below. The device can be oriented in other ways (rotated 90 degrees or other directions), and the spatial relative descriptors used in the present invention can be interpreted accordingly. Similarly, unless otherwise expressly stated, the terms "upward", "downward", "vertical", "horizontal", etc. used in the present invention are only for explanation purposes.

[0180] When a feature is referred to as being disposed "adjacent" another feature, it may be located adjacent to the other feature without any overlapping or underlying portions, or it may have overlapping or underlying portions with the adjacent feature.

[0181] For ease of description, the present invention may use spatially relative terms such as "proximal" and "distal" to describe the relationship between a certain element or feature and another element or feature. It should be understood that the proximal end describes a spatial position closer to the user or the user's expected position, while the distal end describes a position farther from the user or the user's expected position. In addition, when used with a minimally invasive device such as a catheter, the proximal position and the distal position refer to the portion of the device that is intended to be closer to or farther from the user, respectively, and will not change when the device is used.

[0182] Although the present invention may use the terms "first" and "second" to describe various features / elements (including steps), these features / elements should not be limited by these terms unless the context indicates otherwise. These terms can be used to distinguish one feature / element from another feature / element. Therefore, a first feature / element can be called a second feature / element, and similarly, a second feature / element can be called a first feature / element without departing from the teachings of the present invention.

[0183] As used herein, including in the examples, unless otherwise expressly stated, all numerical values ​​may be understood to begin with the word "about" or "approximately", even if the term does not explicitly appear "about" or "approximately". The phrase "about" or "approximately" may be used to describe magnitude and / or position to indicate that the value and / or position are within a reasonable expected value and / or expected position range, respectively. For example, a numerical value may have + / -0.1% of the value (or value range), + / -1% of the value (or value range), + / -2% of the value (or value range), + / -5% of the value (or value range), + / -10% of the value (or value range), etc. Unless the context indicates otherwise, any numerical value given herein should also be understood to include approximately or approximately the value. For example, if the value "10" is disclosed, "about 10" is also disclosed. Any numerical range described herein is intended to include all subranges contained therein. It should also be understood that when a value is disclosed, it also discloses "less than or equal to the value", "greater than or equal to the value", and possible ranges between the values, as appropriately understood by those skilled in the art. For example, if the value "X" is disclosed, "less than or equal to X" and "greater than or equal to X" are also disclosed (e.g., where X is a numerical value). It should also be understood that throughout the application, data is provided in a variety of different formats, and the data represents endpoints and starting points, as well as ranges for any combination of data points. For example, if a specific data point "10" and a specific data point "15" are disclosed, it should be understood that data points greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15, as well as between 10 and 15, are all considered disclosed. It should also be understood that each unit between two specific units is also disclosed. For example, if 10 and 15 are disclosed, 11, 12, 13, and 14 are also disclosed.

[0184] The present invention discloses systems, devices and methods for guiding the removal of objects in the body. Specifically, the systems, devices and methods can be applied to pass through compact areas such as the urethra and remove fragments, such as kidney stones or kidney stone fragments, by vacuum tube suction. As used in the present invention, the term "kidney stone" may refer to kidney stone fragments, including fragments produced by therapeutic fragmentation of kidney stones (e.g., using the device described in the present invention or by other devices). The term "kidney stone" may refer to stones or stone fragments located in the ureter and kidney, and the systems, devices and methods disclosed in the present invention can remove kidney stones from the kidney or ureter.

[0185] Although various exemplary embodiments are described above, many changes may be made to the various embodiments without departing from the scope of the invention as described in the claims. For example, in alternative embodiments, the order in which the various described method steps are performed may generally be changed, while in other alternative embodiments, one or more method steps may be skipped entirely. Optional features of the various device and system embodiments may be included in certain embodiments and not included in other embodiments. Therefore, the above description is provided primarily for exemplary purposes and should not be construed as limiting the scope of the invention as described in the claims.

[0186] The embodiments and illustrations included in the present invention show specific embodiments of the practical subject matter in an illustrative and non-limiting manner. As mentioned above, other embodiments can be used and derived therefrom, so that structural and logical substitutions and changes can be made without departing from the scope of the present invention. Such embodiments of the subject matter of the present invention may be referred to as the term "invention" individually or collectively in the present invention, only for convenience, and are not intended to voluntarily limit the scope of the present application to any single invention or inventive concept (if multiple inventions or inventive concepts are actually disclosed). Therefore, although the present invention has illustrated and described specific embodiments, any arrangement intended to achieve the same purpose can also replace the specific embodiments shown. The present invention is intended to cover any and all adaptations or variations of various embodiments. The combination of the above-mentioned embodiments with other embodiments not specifically described in the present invention will be obvious to those skilled in the art after browsing the above description.

[0187] It should be understood that the present invention is in many respects only an example of the numerous alternative device embodiments of the present invention. Without exceeding the scope of the various embodiments of the present invention, the details may be changed, particularly the shapes, sizes, materials and arrangements of the various device components. It will be understood by those skilled in the art that the exemplary embodiments and descriptions thereof are only overall examples of the present invention. Although several principles of the present invention are clearly defined in the above exemplary embodiments, it will be understood by those skilled in the art that modifications of structure, arrangement, ratio, element, material and method of use may be utilized in the practice of the present invention, as well as other modifications that are particularly suitable for specific environments and operating requirements without departing from the scope of the present invention. In addition, although certain features and elements have been described in conjunction with specific embodiments, it will be understood by those skilled in the art that those features and elements may be combined with other embodiments disclosed in the present invention.

Claims

1. A kidney stone removal device comprising: Irrigation tube; vacuum tubes; and A trigger mechanism includes a user-operable trigger located at a proximal end of the kidney stone removal mechanism, the trigger mechanism being operable to selectively retract, close, and open the irrigation tube to irrigate a treatment area when the user operates the trigger, and to selectively activate a vacuum within the vacuum tube to remove part or all of a kidney stone when the user operates the trigger.

2. The kidney stone removal mechanism according to claim 1, wherein: The trigger includes a first protrusion, and wherein a user operates the trigger to cause the first protrusion to selectively retract, close, and open the irrigation tube.

3. The kidney stone removal mechanism according to claim 2, wherein: The user operates the trigger to cause the first protrusion to gradually open the irrigation tube.

4. The kidney stone removal mechanism according to any one of claims 1 to 3, wherein: The trigger includes a second protrusion, and wherein a user operates the trigger to cause the second protrusion to selectively activate a vacuum within the vacuum tube.

5. The kidney stone removal mechanism according to claim 4, wherein: The user operates the trigger to cause the second protrusion to gradually activate the vacuum in the vacuum tube.

6. The kidney stone removal mechanism according to any one of claims 1 to 5, further comprising: a catheter connected at a proximal end thereof to a distal end of the kidney stone removal mechanism, the catheter having a distal tip at a distal end thereof; and A steering mechanism is located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of part or all of the kidney stone.

7. The kidney stone removal mechanism according to claim 6, wherein: The steering mechanism includes at least one wire connected between the steering mechanism and the catheter for moving the distal tip to a desired position to facilitate removal of part or all of the kidney stone.

8. The kidney stone removal mechanism according to any one of claims 2 to 7, wherein: The first protrusion includes a roller.

9. The kidney stone removal mechanism according to any one of claims 4 to 8, wherein: The second protrusion includes a roller.

10. The kidney stone removal mechanism according to any one of claims 1 to 9, wherein: The trigger includes a third protrusion, and the trigger mechanism includes a first detent selectively engageable with the third protrusion to alert the user to a predetermined amount of depression of the trigger.

11. The kidney stone removal mechanism according to claim 10, wherein: The first stop comprises a raised edge located inside the trigger mechanism.

12. The kidney stone removal mechanism according to claim 10, wherein: The first stop comprises a recessed edge located within the trigger mechanism.

13. The kidney stone removal mechanism according to claim 10, wherein: The third protrusion includes a roller.

14. The kidney stone removal mechanism according to any one of claims 10-13, further comprising a second stopper to remind the user of the full depression amount of the trigger.

15. The kidney stone removal mechanism according to claim 14, wherein: The second stopper includes the protrusion located inside the trigger mechanism.

16. The kidney stone removal mechanism according to claim 14, wherein: The second stopper includes opposite edges of a recess located inside the trigger mechanism, and the third protrusion engages with the opposite edges of the recess to remind the user of the full depression amount of the trigger mechanism.

17. The kidney stone removal mechanism according to any one of claims 1 to 16, further comprising a resilient device that interacts with the trigger mechanism to return the trigger mechanism to an initial position in response to a user releasing the trigger.

18. The kidney stone removal mechanism according to claim 17, wherein: The elastic device comprises a spring.

19. The kidney stone removal mechanism of any one of claims 1-18, further comprising a vacuum activated tube connected to the vacuum tube.

20. The kidney stone removal mechanism according to claim 19, wherein: The second protrusion activates the vacuum within the vacuum tube by clamping the vacuum activation tube.

21. The kidney stone removal mechanism according to claim 19, wherein: The second protrusion activates the vacuum within the vacuum tube by covering the port of the vacuum activation tube.

22. A method of kidney stone removal comprising operating the kidney stone removal mechanism of any preceding claim.

23. A kidney stone removal device comprising: an irrigation tube configured to carry a fluid and having a portion extending within the trigger mechanism; and a bypass structure connected to the irrigation tube at two locations and configured to allow fluid to flow from a first portion of the irrigation tube to a second portion of the irrigation tube without passing through the portion of the irrigation tube located within the trigger mechanism; in, The trigger mechanism includes a trigger operable by a user, the trigger mechanism being operable to selectively retract, close, and open the first irrigation tube to irrigate a treatment area when the user operates the trigger.

24. The kidney stone removal mechanism according to claim 23, wherein: The bypass structure includes a flow restriction.

25. The kidney stone removal mechanism according to claim 23 or 24, wherein: The user presses the trigger to gradually open the irrigation tube.

26. The kidney stone removal mechanism of any one of claims 23-25, further comprising a vacuum tube configured to be activated by the trigger mechanism.

27. The kidney stone removal mechanism according to any one of claims 23-26, further comprising: a catheter connected at a proximal end thereof to a distal end of the kidney stone removal mechanism, the catheter having a distal tip at a distal end thereof; and A steering mechanism is located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of part or all of the kidney stone.

28. A method for removing kidney stones, comprising operating the kidney stone removal mechanism according to any one of claims 23-27.

29. A kidney stone removal device comprising: Irrigation tube; Vacuum tubes; a stone trap assembly in communication with the vacuum tube; and A flow indicator mechanism includes a flow indicator connected to the stone trap assembly.

30. The kidney stone removal mechanism of claim 29, wherein: The flow indicator includes one or more vanes that move in response to fluid or air flow.

31. The kidney stone removal mechanism of claim 29 or 30, further comprising: a catheter connected at a proximal end thereof to a distal end of the kidney stone removal mechanism, the catheter having a distal tip at a distal end thereof; and A steering mechanism is located at the proximal end of the kidney stone removal mechanism, the steering mechanism being operable to steer the distal tip to facilitate removal of part or all of the kidney stone.

32. A method for removing kidney stones, comprising operating the kidney stone removal mechanism of any one of claims 29-31.

33. The kidney stone removal mechanism according to any one of claims 1-32, further comprising: A nozzle comprising a vacuum lumen in communication with the vacuum tube and sized to remove kidney stones or kidney stone fragments, and One or more irrigation ports in communication with the irrigation tube, each of which is located at the distal end of the nozzle and has an irrigation port departure angle of 30 to 60 degrees for directing irrigation fluid forward and laterally from the distal end of the nozzle.

34. The kidney stone removal mechanism of claim 33, wherein: At least one of the irrigation ports has an arcuate shape.

35. A kidney stone removal device comprising: kidney stone removal catheters; and a nozzle included at the distal end of the catheter; wherein The nozzle includes a vacuum lumen sized to remove kidney stones or kidney stone fragments and one or more irrigation ports at a distal end of the nozzle, at least one of the irrigation ports having an irrigation port departure angle of 30 to 60 degrees for directing irrigation fluid forwardly and laterally from the distal end of the nozzle.

36. The kidney stone removal mechanism of claim 35, comprising: a first irrigation port configured to direct irrigation fluid forward but not in a radially divergent direction; and a second irrigation port configured to direct irrigation fluid in a radially divergent direction.

37. The kidney stone removal mechanism according to claim 35 or 36, wherein: At least two of the irrigation ports have different opening sizes, different shapes, and / or different irrigation port departure angles.

38. The kidney stone removal mechanism of claim 37, wherein: The first perfusion port is one of a circular, elliptical, or arcuate shape, and the second perfusion port has a shape different from the first perfusion port and is one of a circular, elliptical, or arcuate shape.

39. The kidney stone removal mechanism of claim 35, comprising a first irrigation port located directly between a second irrigation port and a third irrigation port, wherein the arc distance between the first irrigation port and the second irrigation port is different from the arc distance between the first irrigation port and the third irrigation port.

40. The kidney stone removal mechanism of any one of claims 35-39, further comprising an image sensor and a light source.

41. The kidney stone removal mechanism of claim 40, wherein: The nozzle includes an upper recess for receiving the image sensor and the light source.

42. The kidney stone removal mechanism of any one of claims 35-41, further comprising a distal manifold configured to be inserted into the proximal end of the nozzle, the distal manifold having a conduit for directing irrigation fluid to the irrigation port of the nozzle.

43. The kidney stone removal mechanism of claim 42, further comprising a shaft manifold configured to be connected to the distal manifold, the shaft manifold having an irrigation lumen for directing irrigation fluid to the conduit of the distal manifold.

44. The kidney stone removal mechanism according to any one of claims 35 to 43, wherein: The nozzle includes a distal face having a rounded edge or a curved edge.

45. The kidney stone removal mechanism according to any one of claims 35-44, wherein: The vacuum lumen is offset from the center of the nozzle.

46. ​​The kidney stone removal mechanism according to any one of claims 35 to 45, wherein: The nozzle includes at least one conduit for providing a fluid path between the catheter and the irrigation port, and wherein the at least one conduit includes a divider for directing fluid to the irrigation port.

47. A kidney stone removal system comprising: (a) vacuum tubes; and (b) a laser guide configured to be removably inserted into the vacuum tube, wherein the laser guide comprises: (i) a tubular body having a lumen configured to receive a laser device, and (ii) a wing extending from a distal section of the tubular body, the wing being used to guide the distal section of the tubular body in the vacuum tube and to create a flow gap between the tubular body and the vacuum tube.

48. The kidney stone removal system of claim 47, wherein: The tubular body is configured so that when the tubular body is fully inserted into the vacuum tube and placed in an operating position, the tubular body does not extend beyond the distal end of the vacuum tube.

49. The kidney stone removal system of claim 47, wherein: The guide comprises 2 to 4 wings.

50. The kidney stone removal system of claim 47, wherein: The guide is composed of 3 or 4 wings, and the circumferential distance between each pair of adjacent wings is the same.

51. The kidney stone removal system of claim 47, wherein: The guide is composed of 3 or 4 wings, and the circumferential distance between a first pair of adjacent wings is different from the circumferential distance between a second pair of adjacent wings.

52. The kidney stone removal system of claim 51, wherein: The first pair of adjacent wings shares a common wing with the second pair of adjacent wings.

53. The kidney stone removal system of claim 47, wherein: At least two of the gaps have different sizes.

54. The kidney stone removal system of any one of claims 47-53, wherein: Each wing portion each includes a middle section having a rectangular shape that transitions into a tapered end section that slopes downwardly into the tubular body.

55. The kidney stone removal system of any one of claims 47-54, wherein: Each wing has a respective variable thickness that increases along the longitudinal axis from a proximal end of the wing to a distal end of the wing.

56. The kidney stone removal system of any one of claims 47-55, wherein: Each wing has a respective longitudinal axis that is angled relative to the longitudinal axis of the tubular body.

57. The kidney stone removal system of any one of claims 47-56, further comprising an actuator for moving the tubular body within the vacuum tube.

58. The kidney stone removal system of claim 57, wherein: The actuator comprises: (a) biasing element; and (b) a shaft portion coupled to the tubular body such that actuation of the biasing element causes the shaft portion to move the tubular body in a front-to-rear direction within the vacuum tube.

59. The kidney stone removal system of claim 58, wherein: The shaft portion is configured to be detachably coupled to the proximal end of the tubular body.

60. The kidney stone removal system of claim 58, wherein: The shaft portion is permanently attached to the proximal end of the tubular body.

61. The kidney stone removal system of claim 58, wherein: The biasing element includes a band portion coupled to a distal segment of the shaft portion, and wherein the actuator further includes a cylindrical housing coupled to the band portion and configured to receive the shaft portion such that inward compression and release of the band portion causes a portion of the shaft portion to telescopically move into and out of the cylindrical housing.

62. The kidney stone removal system of any one of claims 57-61, wherein: The actuator includes a channel for receiving the laser device, wherein the channel is configured to communicate with the lumen of the tubular body.

63. A catheter assembly comprising: (a) vacuum tubes; and (b) a guide device configured to be removably positioned in the vacuum tube for receiving a fragment breaking device, in, The guide device is configured to prevent accidental movement of the breaker device when the breaker device is positioned at the distal end of the vacuum tube while allowing fluid and debris to flow past the breaker device and through the vacuum tube.

64. The catheter assembly of claim 63 further comprising an actuator for moving the guide within the vacuum tube to clear debris.

65. The catheter assembly of claim 63 or 64, wherein: The fragmentation device comprises a laser optical fiber.

66. A method of removing kidney stones, comprising operating the kidney stone removal mechanism of any one of claims 47-62 or the catheter assembly of any one of claims 63-65.

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