In-scope direct suction system

Abstract

The invention disclosed herein presents a novel intra-scope direct aspiration system designed for retrieving stone fragments from within the body. This system comprises two major components: a stone fragment retrieval device and a pump unit. The stone fragment retrieval device features a main body with a single operating water conduit containing both an irrigation port and an aspiration port, which are connected to the respective irrigation and aspiration pumps via elastomer-based rubber tubing. This setup allows for the controlled infusion of saline into the body cavity during the lithotripsy procedure, ensuring clear visibility and the removal of debris. The retrieval device includes a trigger lever connected to a clamping tab. When the operator presses the trigger lever, the clamped aspiration tube is released, opening the aspiration port and increasing intra-body pressure.

Description

[Technical Field]

[0001] The present invention relates generally to the field of medical devices, and more particularly to an endoscopic device with a suitable working device having an irrigation and aspiration system that allows for easy and rapid recovery of stone fragments and / or stone dust from a patient's kidney. [Background technology]

[0002] Kidney stones (medically known as ureteral stones) are a common medical problem that affects millions of people worldwide. Kidney stones are typically made of crystals and comprise one or more solid masses that form in parts of the urinary tract, including the ureter, kidney, and / or bladder. Kidney stones can range in size from small (approximately 1 cm or less) to very large (4 cm or more), causing significant pain to the patient and potentially damaging the kidney. The vast majority of stones treated by surgeons are smaller than 1 cm.

[0003] The recommended treatment for kidney stone removal depends on many factors, including the size of the kidney stones, the number of kidney stones, and the location of the kidney stones. The most common treatments for kidney stones are shock wave lithotripsy, ureteroscopy, retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotripsy. Most large kidney stones are usually removed by percutaneous nephrolithotripsy or nephrolithotripsy, or other similar procedures.

[0004] Traditionally, smaller kidney stones have been treated using other, less invasive procedures, such as ureteroscopy. During ureteroscopy, surgeons typically insert a ureteroscope through the bladder and ureter into the urethra to directly visualize the kidney stone in the ureter or kidney. If the kidney stone is small enough to pass through the urinary tract without difficulty, surgeons can then directly remove it using a basket device or break it into smaller pieces using a fragmentation device, such as a laser. After breaking the kidney stone into smaller pieces, surgeons remove the laser or fragmentation device and insert a basket or other device to capture the kidney stone fragments under direct vision with the ureteroscope. After retrieving some of the kidney stone fragments, surgeons remove the basket from the patient and empty the kidney stone fragments from it. This process is repeated until clinically significant kidney stones or kidney stone fragments have been broken up and passed out of the body.

[0005] Stent placement is usually performed after laser lithotripsy under local or general anesthesia. The patient is monitored and kept at rest, and a Foley catheter is placed to drain urine into a urine bag. After 24 hours of observation, the patient is discharged once the urine is clear, and the stent remains in place for one week. During this time, the patient is asked to retrieve stone fragments with a gauge or stone-collecting mesh; however, it is impossible to catch such small stones. After one week, the patient must be hospitalized again to have the ureteral stent removed.

[0006] Because surgeons must repeatedly move the scope (ureteroscope) and basket in and out of the patient to completely remove the kidney stones and stone fragments, this process is obviously very time-consuming, costly, and inefficient. Using a basket removal device to capture kidney stones or stone fragments suffers from other drawbacks, including the difficulty of positioning the basket adjacent to the kidney stone fragments and maneuvering it to effectively retrieve the kidney stone fragments. Furthermore, in most cases, the stent causes discomfort to the patient, especially during transport. Stent removal requires the patient to be re-admitted to the hospital, which must be done under anesthesia. Furthermore, capturing a sufficient number of stone fragments for stone analysis is very difficult. Because Foley catheter removal is not performed under anesthesia, it is extremely painful. It is also impossible to confirm whether all stone fragments have been expelled from the kidney. Furthermore, the lengthy operation of the kidney stone retrieval basket can easily tire the surgeon's hands. Furthermore, the patient is required to be under local anesthesia and / or remain immobile for extended periods of time. Additionally, basket retrieval devices can be irritating to the urinary tract due to their repeated insertion and removal.

[0007] New developments in laser technology have made it possible to not only fragment stones but also to "pulverize" them. This technique breaks up stones into smaller and smaller particles of sand, measuring 0.5 mm or less. The intense light energy from a laser built into the ureteroscope breaks the stone into smaller and smaller pieces. Pulverization does not break up stones into chunks that can be removed with a basket, but rather produces very small fragments that can pass naturally. However, in some cases, these small stone fragments may not pass naturally. Theoretically, these stone fragments that are not passed by the natural urinary flow could serve as seeds for the growth of new stones. Despite these recent advances, it is difficult to remove all stones and stone fragments, in part because pulverization produces a cloud of particles that makes it difficult to visualize the remaining stones and fragments through the cloud.

[0008] When small stones or stone debris reside in the renal pelvis of the kidney, and access to the renal pelvis is more difficult, a more robust clearance mechanism is desirable. Thus, there is an unmet need for improvement and a need for new devices and methods to remove kidney stones minimally invasively.

[0009] The present invention is therefore directed to developing a system that facilitates the rapid, efficient and complete removal of stone fragments or powder that cannot be captured by the stone basket by applying suction. Summary of the Invention

[0010] SUMMARY OF THE INVENTION The embodiments of the present disclosure provide technical improvements as solutions to one or more of the above-mentioned technical problems identified by the inventors in conventional systems.

[0011] SUMMARY OF THE INVENTION An object of the present invention is to provide a stone fragment recovery device that eliminates the need for a stone capture basket and completely removes the sand and dust particles of crushed kidney stones.

[0012] Another object of the present invention is to provide an improved stone fragment retrieval device and system, and more particularly, to facilitate simultaneous use of an actuated conduit for stone fragmentation, irrigation, and aspiration within a patient's body that is easy for a physician to use.

[0013] It is yet another object of the present invention to provide a stone fragment retrieval device and system that selectively varies the suction or irrigation flow within the working conduit to expel sand and dust fragments from crushed kidney stones.

[0014] It is yet another object of the present invention to provide a medical endoscope (ureteroscope) and system that reduces intrarenal pressure and improves visualization of stones during surgery.

[0015] A further object of the present invention is to avoid the need for stent placement or a Foley catheter, ultimately reducing surgical time and patient recovery time.

[0016] One aspect of the present disclosure provides an intra-scope direct suction system including a stone fragment retrieval device and a pump unit. The stone fragment retrieval device comprises a main body having a single operating water conduit with an irrigation port and an suction port connected to an irrigation pump and an suction pump via a rubber tube made of elastomer. The stone fragment retrieval device also includes a trigger lever attached to a clamping tab. The trigger lever selectively controls the flow of suction or irrigation to the operating water conduit. In the normal state, i.e., when the irrigation port is normally open and the suction port is closed, saline is injected into the body cavity through the scope via the peristaltic irrigation pump to remove stone fragments and debris as the stone fragmentation progresses and to maintain a clear view through the endoscope during the procedure. When the operator presses the trigger lever, the clamping of the suction rubber tube, which increases pressure within the kidney, is released, and the suction port opens. The T-connector is attached to the irrigation and suction unit, which has a diaphragm that expands due to the increase in pressure, eventually activating a switch that sends a signal to the PCB to close the peristaltic irrigation pump. Stone dust is extracted along with the fluid in the body cavity, passing through a filter into a collection container. Once the suction function has been performed and all dust particles have been extracted, the operator can release the trigger lever by returning it to its original position.

[0017] Additional aspects, advantages, features and objects of the present disclosure will become apparent from the drawings and detailed description of illustrative embodiments.

[0018] It will be understood that features of the present disclosure can be combined in various combinations without departing from the scope of the present disclosure, which is defined by the following detailed description and drawings. [Brief explanation of the drawings]

[0019] The above summary, and the following detailed description of exemplary embodiments, will be better understood when read in conjunction with the accompanying drawings. For the purpose of illustrating the disclosure, exemplary structures of the disclosure are shown in the drawings. However, the disclosure is not limited to the particular methods and apparatus disclosed herein. Moreover, those skilled in the art will appreciate that the drawings are not to scale. Wherever possible, similar elements are designated by the same numerals.

[0020] Embodiments of the present disclosure will now be described, by way of example only, with reference to the following figures:

[0021] FIG. 1 shows an isometric view of an intra-scope direct aspiration system according to an exemplary embodiment of the present disclosure.

[0022] FIG. 2 is an isometric view of a stone fragment retrieval device attached to an endoscope in accordance with an exemplary embodiment of the present disclosure.

[0023] FIG. 3 is an exploded perspective view of a stone fragment retrieval device having an exemplary embodiment of the present disclosure.

[0024] 4(a)-4(b) are cross-sectional views of a stone fragment retrieval device according to an exemplary embodiment of the present disclosure.

[0025] FIG. 5 illustrates a filter device according to an exemplary embodiment of the present disclosure.

[0026] FIG. 6(a) is an exploded view of a pump unit of an intra-scope direct aspiration system according to an exemplary embodiment of the present disclosure.

[0027] FIG. 6(b) is a top view of a pump unit of an intra-scope direct aspiration system according to an exemplary embodiment of the present disclosure.

[0028] FIG. 6(c) is a perspective view of a tubing assembly of a pump unit of an endoscope direct aspiration system according to an exemplary embodiment of the present disclosure.

[0029] FIG. 7 is a schematic diagram of an intra-scope direct aspiration system according to an exemplary embodiment of the present disclosure.

[0030] In the accompanying drawings, numbers refer to items identified by a line connecting the number and the item. Where a number is accompanied by an associated arrow, the number is used to identify the general item to which the arrow is pointing.

[0031] Moreover, the figures depict various embodiments of the present subject matter for purposes of illustration only. Those skilled in the art will readily recognize from the following discussion that alternative embodiments of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein. DETAILED DESCRIPTION OF THE INVENTION

[0032] The following detailed description illustrates embodiments of the present disclosure and the manner in which they may be practiced. The words "comprising," "having," "containing," and "including," as well as other forms thereof, are intended to be equivalent in meaning and open-ended, in that the items or items following any one of these words are not intended to be an exhaustive list of such items or items, nor are they intended to be limited to only the listed items or items. It should also be noted that as used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. As used herein, "plurality" refers to two or more, e.g., three or more, four or more, five or more, six or more. Each possibility represents a separate embodiment of the present invention.

[0033] For purposes of this specification and claims, various relative terms such as "upper," "lower," "proximal," "distal," "above," "below," "anterior," and "posterior" are used to describe the invention when positioned or viewed in a given orientation. It is understood that different orientations of the invention may require the appropriate adjustment of certain relative terms.

[0034] Those skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure. It is to be understood that the present invention is not limited to the particular methodology, protocols, etc. described herein, as such may vary. The terminology used herein is for the purpose of describing particular embodiments only, and is not intended to limit the scope of the present invention, which is defined solely by the claims.

[0035] Referring now to the drawings, Figures 1-7 illustrate a direct endoscope aspiration system having an improved aspiration and irrigation mechanism for complete extraction of dust particles from the kidney in accordance with the present invention. Figures 1-7 illustrate a direct endoscope aspiration system having an improved aspiration and irrigation mechanism for complete extraction of dust particles from the kidney in a more efficient and rapid manner in accordance with the present invention. It should be noted that Figures 1-7 are merely exemplary. One skilled in the art will recognize many variations, alternatives, and modifications of the disclosed embodiments.

[0036] Referring now to the drawings, Figure 1 shows an intra-scope direct aspiration system 100 comprising a stone fragment retrieval device 102 comprising a number of tubes, in particular an irrigation tube 104 and an aspiration tube 106. The aspiration tube is connected to a dust particle / sand collecting filter 108 which is in fluid communication with a water collecting container 110. An outlet tube 112 from the container 110 is connected to an irrigation aspiration pump unit 114.

[0037] 2 shows a stone fragment retrieval device 102 comprising a body 202 configured to be coupled to an endoscope 204 using a scope port connector 206 and a flange 208 attached to the endoscope 204. The scope port connector 206 is adapted to be attached to a 7.5 Fr or 9 Fr flexible ureteroscope.

[0038] Referring now to Figure 3, an exploded perspective view 300 of the stone fragment retrieval device 102 is shown. The body 202 includes an elongated section 302 (hereinafter referred to as the "working conduit") having a proximal end 304 and a distal end 306. The distal end 306 is coupled to an endoscope 204 using a scope port connector 206. Laser lithotripsy uses a laser that generates dust within the body cavity to fragment kidney stones. A laser fiber is introduced through the proximal end 304 of the working conduit 302 to perform the laser lithotripsy procedure.

[0039] The main body 202 includes an irrigation port 308 and a suction port 310 near the proximal end 304 of the working conduit 302 for supplying saline to the urinary system and extracting dust particles. The irrigation port 308 and the suction port 310 are connected to the working conduit 302 via an irrigation rubber tube 104 and a suction rubber tube 106 inside the main body 202, which are connected to an irrigation and suction pump unit 114, as shown in FIG. 1 . The rubber tubes 104 and 106 are made of an elastomeric material, such as silicone. The main body 202 also includes a trigger lever 314 attached to a clamping tab 316. The trigger lever 314 can rotate a certain angle against a torsion spring 318 coupled to the main body 202. The spring 318 assists the trigger lever 314 in returning to its original, fixed position after rotation. The stone fragment retrieval device is made of a plastic material.

[0040] 3 is merely exemplary. One skilled in the art will recognize many variations, alternatives, and modifications of the disclosed embodiments. The material of the tube in the present invention is not limited to elastomers and can vary depending on the thickness and flexibility requirements of the tube.

[0041] Referring now to Figures 4(a) and 4(b), a cross-sectional view 400 of the stone fragment retrieval device main body 202 is shown. Figure 4(a) shows the stone fragment retrieval device 102 in its normal state, i.e., with the irrigation port 308 open and the suction port 310 closed. When using a stone retrieval device to perform endoscopic procedures within a body cavity or urinary tract, particularly when performing lithotripsy, a common problem is that stone fragments or debris from the lithotripsy procedure obscure the endoscopic view. A means of removing such debris is desirable both to remove debris as the stone fragmentation progresses and to maintain a clear view through the endoscope during the procedure. During the irrigation function, saline is infused into the body cavity through the scope. This saline is necessary to maintain a clear view within the body and also as a power transmission medium for the laser, as well as for the pulverization operation. The clamping tab 402 has an upper tab 404 and a lower tab 406. As shown in Figure 4(a), the suction rubber tube 106 is clamped using an upper clamping tab 404 attached to the trigger lever 314. The suction rubber tube 106 is clamped between the wedge of the clamping tab 402 and the wall of the main body 202. A torsion spring 318 keeps the trigger lever 314 in a position where the suction rubber tube 106 is always clamped.

[0042] The irrigation tube 104 and the suction tube 106 are arranged so that only one can be activated at a time. A trigger lever 314 is used to select either the suction or irrigation function. The suction function is performed to extract stone dust fragments along with the fluid in the body cavity. Figure 4(b) shows the stone fragment retrieval device in a state where the suction port 310 is open and the irrigation port 308 is closed. While the operator presses the trigger lever 314, the lower tab 406 pinches the irrigation tube 104, thereby releasing the pinched state of the suction tube 106 and opening the suction port 310, allowing stone dust fragments and sand to be discharged from the suction tube 106 through the suction port 310.

[0043] 4(a)-4(b) are merely examples. One skilled in the art would recognize many variations, alternatives, and modifications of the disclosed embodiments.

[0044] FIG. 5 shows a cross-section 500 of the filter 108 connected to a collection container 110 for collecting urine and water. The filter 108 is configured as a chamber and may include one or more particulate filters to enable quantification and collection of sand and debris. The filter 108 and container 110 are configured to be in fluid communication with both the stone fragment retrieval device and the pump unit 114 via the suction tube 106 and may be located downstream of the ureteroscope 204 and upstream of the irrigation suction pump unit 114. During operation, when the suction port 310 is open, the filter 108 captures large-sized dust contaminants, i.e., coarse dust, through the filter's media 502 as urine and dust particles enter the filter 108 through the filter's inlet 504. Smaller-sized contaminants in the form of fine dust are passed through the filter's media 502 through the filter's outlet 506, and the fine dust and urine mixture is collected in the collection container 110. The outlet of the drain collection container 110 is connected to a suction pump 602, as shown in Figure 6(a). The collected sample of dust in the filter can be directly delivered to a pathology laboratory for further testing.

[0045] FIG. 6(a) shows an exploded perspective view 600 of the pump unit 114. The irrigation suction pump unit 114 includes a suction pump 602 having an inlet port 604 and an outlet port 606. The pump unit 114 also includes a proportional valve 608 with a PCB 610 (shown in FIG. 7(b)). The proportional valve 608 regulates the vacuum generated in the suction container 114 by applying a variable current to the proportional valve 608 using a suction keypad 612 provided on the pump unit 114. When a user presses the suction keypad 612, the proportional valve 608 opens and closes. As the user increases the reading on the keypad 612, the proportional valve 608 begins to close, thereby increasing suction. When the proportional valve 608 is fully closed, suction is maximized, and vice versa.

[0046] Additionally, there is a Y-tube assembly 614 having a common tube 616 connected to the proportional valve 608, a first tube 618 connected to the injection port 604 of the suction pump 602, and a second tube 620 connected to the suction reservoir tube 112.

[0047] Saline is continuously supplied to the peristaltic perfusion pump 622. The pump unit 114 further includes an perfusion tube assembly 624, with three tubes connected via a T-connector 626. A portion of the plastic T-connector 626 is connected to the peristaltic perfusion pump 622 via a tube 628 (shown in FIG. 7(b)) that is further connected to the saline solution. An intermediate portion of the T-connector 626 extends within the perfusion suction pump unit 114 and is configured to be covered by a diaphragm / pressure sensor device / or switch actuator 630 located within the perfusion suction pump unit 114 near a switch 632. The third end of the T-connector 626 is connected to the stone fragment retrieval device body 202 via a tube 634 that continuously supplies saline to the kidney via the operating water conduit during operation. The T-connector 626 is attached to a switch actuator holder assembly 636 attached to the outer periphery of the perfusion suction pump unit 114. The stone fragment retrieval device 102, filter container 108 and T-connector assembly 626 are disposable and must be replaced after each surgery.

[0048] FIG. 7 shows a schematic diagram 700 of the intra-scope direct suction system 100. As can be seen, saline 702 is supplied to a peristaltic irrigation pump 622. In default mode, the suction port 310 is closed. When the surgeon presses the trigger lever 314, the irrigation port 308 closes and the suction port 310 opens, increasing pressure in the irrigation pump 622, potentially harmful to the patient. This pressure increase causes a rubber diaphragm 630 at the second end of the T-connector 626 to expand, actuating a tactile switch 632 that sends a signal to the PCB 610 in the irrigation suction pump unit 114 to switch off the irrigation pump 622 in the form of an LED on the irrigation keypad 638. Sand and dust particles are expelled from the kidney through the suction port 310, the suction tube 106, and the filter 108 into the collection container 110.

[0049] It was confirmed that dust particles after lithotripsy treatment could be removed more quickly and efficiently.

[0050] It is further observed that, along with eliminating the basket means for capturing stones, the direct suction system provides the much-needed advantage of efficiently extracting debris from the kidney, avoiding the additional discomfort to the patient associated with traditional methods of removing stones from the kidney. Along with these advantages, rapid and complete extraction of debris is possible, ultimately saving time for the patient as well as the physician described in this invention.

[0051] The present invention has technical and economical advantages over conventional kidney stone retrieval devices.

[0052] While specific embodiments of the present invention have been shown and described, modifications thereof will readily occur to those skilled in the art. It is understood that the various embodiments, details, and configurations of the stone fragment retrieval device, the intra-scope direct aspiration system, and their features described above and illustrated in the accompanying drawings may be interchanged between various embodiments while remaining within the scope of the present invention. Furthermore, it is understood that various modifications may be made to any of the stone fragment aspiration devices and / or components described hereinabove while remaining within the scope of the present invention.

Claims

1. a stone fragment retrieval device (102) comprising a body (202) having a proximal end (304) and a distal end (306), the body (202) having an aqueduct (302) configured to be removably attached to a ureteroscope (104) via a scope connection port (206); The aqueduct 302 serves as a medium for introducing laser fibers or other surgical accessories, infusing saline into the kidney, and aspirating debris from the patient's kidney; The conduit 302 further includes an inlet port 308 and an outlet port 310 near the proximal end 304 of the conduit 302; The inlet port 308 and outlet port 310 are connected to the inlet tube 104 and outlet tube 106, which are further connected to the pump unit 114 for irrigation and negative pressure. The trigger lever 314 is rotatable against a torsion spring 318 and is coupled to a pinch tab 316 on the body 102; The pinch tabs 316, comprised of an upper tab 404 and a lower tab 406, selectively control the flow of aspiration and irrigation through the actuation conduit when the user presses the trigger lever 314. An intrascope direct aspiration system for removing stone fragments from patients.

2. 2. The stone fragment retrieval device according to claim 1, wherein the injection port (308) is an irrigation port for injecting saline into the patient's kidney, and is connected to an irrigation source via an injection tube (104).

3. 2. The stone fragment retrieval device of claim 1, wherein the discharge port is a suction port for suctioning debris and urine from the patient's kidney, and is connected to a negative pressure source via a discharge tube.

4. 2. The stone fragment retrieval device of claim 1, wherein when the trigger lever is in the normal position, the upper tab of the clamping tab maintains the flow blocked from the suction tube for continuous flow of saline through the irrigation tube.

5. 2. The stone fragment retrieval device of claim 1, wherein when a user presses the trigger lever 314, negative pressure is applied and the lower tab 406 of the clamping tab 316 blocks flow from the irrigation tube 104, allowing debris and urine to ultimately be removed through the suction tube 106.

6. 1. An intra-scope direct aspiration system for removing stone fragments from a patient, comprising a stone fragment retrieval device 102 and a pump unit 114, The pump unit 114 includes a suction pump 602 that supplies negative pressure to the main body of the stone fragment recovery device, a proportional valve 608 connected to a printed circuit board 610, wherein the proportional valve 608 regulates the vacuum created in the suction vessel 110 attached to the pump unit 114; a peristaltic irrigation pump 622 for supplying saline to the stone fragment retrieval device body via an irrigation tube assembly 624; a diaphragm 630 disposed inside the irrigation suction pump unit 114 adjacent to a switch 632; Equipped with When the operator presses the trigger lever 314, the clamped suction tube 106 is released, opening the suction port 310, causing the pressure in the body cavity to increase. The increased pressure causes the diaphragm 630 to expand, activating the switch 632 and sending a signal to the printed circuit board 610 to close the irrigation pump 622. In-scope direct suction system.

7. 10. The intra-scope direct suction system of claim 6, wherein the irrigation tube assembly 624 comprises three tubes connected via a T-connector 626, a portion of which is connected to the peristaltic irrigation pump 622 via a tube 628 further connected to physiological saline, an intermediate portion of which extends into the interior of the irrigation suction pump unit 114 and is configured to be covered by a diaphragm 630 disposed inside the irrigation suction pump unit 114 adjacent to a switch 632, and a third end of the T-connector 626 is connected to the stone fragment retrieval device main body 202 via a tube 634 which continuously supplies physiological saline to the kidney via an operating water conduit during operation.

8. The intra-scope direct suction system of claim 6, wherein the proportional valve (608) adjusts the vacuum generated in the suction container (114) by passing a variable current through the proportional valve (608) using a suction keypad (612) provided on the pump unit (114).

9. 7. The intra-scope direct aspiration system of claim 6, wherein the shutdown of the peristaltic irrigation pump due to pressure buildup is provided in the form of an LED on the irrigation keypad 638.

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