Crushed stone extraction system

Abstract

The present disclosure provides a crushed stone extraction system, comprising a delivery apparatus and a hydrogel. The hydrogel comprises a first composition and a second composition. The first composition comprises at least one crosslinkable polymer. The second composition comprises at least one crosslinking agent. The crosslinkable polymer is configured to be delivered to a lithotripsy position by the delivery apparatus and then encapsulate the crushed stones. The crosslinking agent is configured to be delivered to the lithotripsy position by the delivery apparatus and then react with the crosslinkable polymer to form an elastic hydrogel body encapsulating the crushed stones. The delivery apparatus is configured to adsorb the elastic hydrogel body and then remove the crushed stones. The present disclosure can remove multiple or even all of the fine crushed stones that cannot be taken out by conventional means at a time, thereby reducing the pain of patients.

Description

A gravel extraction system

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This disclosure claims priority to Chinese Patent Application No. 202410063937.7 filed in China on January 16, 2024, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to the field of medical technology, and in particular to a lithotripsy system. Background Art

[0004] Lithiasis is a solid mass that forms in the ductal lumen or cavity of a cavitary organ (such as the kidney, ureter, gallbladder, or bladder) in the human or animal body. It is primarily found in the gallbladder, bladder, and renal pelvis, but can also be found in the cavities of the pancreatic duct and salivary duct. Stones can cause severe pain. For example, kidney stones can cause kidney inflammation and even (usually unilateral) acute renal failure. Currently, stones are primarily removed through minimally invasive surgical procedures, such as ureteroscopic lithotripsy (RIRS), percutaneous nephrolithotomy (PCNL), combined laparoscopic lithotripsy (PCNL+RIRS), laparoscopy, and robotic-assisted laparoscopic lithotripsy. However, due to limitations in surgical instruments, it is not possible to completely remove the stones during surgery, especially for small stones. Postoperatively, patients require increased hydration, medication, special body positioning, and external physical vibration to help the stones pass naturally, which is very inconvenient for the patient and carries the risk of a second surgery.

[0005] Summary of the Invention

[0006] In view of the above technical problems, the present disclosure provides a gravel extraction system to solve at least one technical problem existing in the prior art.

[0007] According to a specific embodiment of the present disclosure, in a first aspect, the present disclosure provides a lithotripsy extraction system, comprising a delivery device and a hydrogel, wherein:

[0008] The hydrogel comprises a first composition and a second composition, wherein the first composition comprises at least one cross-linkable polymer, and the second composition comprises at least one cross-linking agent, wherein the cross-linkable polymer is configured to wrap the gravel after being delivered to the gravel location by the delivery device, and the cross-linking agent is configured to react with the cross-linkable polymer after being delivered to the gravel location by the delivery device to form an elastic hydrogel body wrapping the gravel; wherein the cross-linkable polymer and the cross-linking agent are sterilized by high-pressure steam before forming the hydrogel, and the viscosity of the cross-linkable polymer is less than 100 cp;

[0009] The conveying device is configured to absorb the elastic hydrogel and then remove the gravel.

[0010] Optionally, the first composition further comprises at least one dye, and / or the second composition further comprises at least one dye.

[0011] Optionally, the cross-linkable polymer is a cationic cross-linkable polymer.

[0012] Optionally, the cross-linkable polymer includes sodium alginate, and the cross-linking agent includes calcium chloride.

[0013] Optionally, the concentration of the sodium alginate is 0.5%-1.5%, the time of the high-pressure steam sterilization is 5-30 minutes, and the sterilization temperature is greater than 120°C.

[0014] Optionally, the concentration of calcium chloride is 2.0%-10%.

[0015] Optionally, at least 40% of the molecular weight of the sodium alginate is in the range of 110,000-500,000; the sodium alginate is a polysaccharide composed of guluronic acid and mannonic acid; and the content of guluric acid in the sodium alginate is 30%-95%.

[0016] Optionally, the conveying device includes a receiving portion and a catheter, the catheter is communicated with the receiving portion, and after the first composition and the second composition are placed in the receiving portion, they are successively conveyed to the lithotripsy position through the catheter.

[0017] Optionally, the catheter is formed of a flexible material, and the hardness of the flexible material is 72D.

[0018] Optionally, the end of the conduit forms a bell mouth, and the bell mouth is formed of a memory material or a flexible material.

[0019] Compared with the prior art, the above solution of the embodiment of the present disclosure has at least the following beneficial effects:

[0020] The lithotripsy system provided in the embodiments of the present application forms an elastic hydrogel body that encapsulates small stones or stone fragments (hereinafter collectively referred to as lithotripsy). By extracting the elastic hydrogel body, the encapsulated lithotripsy is also extracted, thereby resolving the current clinical challenge of being unable to cleanly remove small, fine stones, reducing patient pain and the likelihood of a second surgery. The elastic hydrogel body formed by the lithotripsy system described in the present application can encapsulate multiple lithotripsy, allowing multiple or even all lithotripsy to be removed at once through a single instrument channel, eliminating the need for instrument replacement, reducing surgical time, and alleviating patient pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] The accompanying drawings are incorporated into and constitute a part of the specification, illustrate embodiments consistent with the present disclosure, and together with the specification, are used to explain the principles of the present disclosure. Obviously, the drawings described below are only some embodiments of the present disclosure, and those skilled in the art can derive other drawings based on these drawings without inventive effort. In the drawings:

[0022] FIG1 is a schematic structural diagram of a gravel extraction system provided by an embodiment of the present disclosure;

[0023] FIG2 is a schematic diagram of gravel that can be extracted by the gravel extraction system provided in an embodiment of the present disclosure;

[0024] FIG3 is a schematic structural diagram of a catheter in a lithotripsy extraction system according to an embodiment of the present disclosure;

[0025] FIG4 is a schematic diagram of a gravel extraction system provided by an embodiment of the present disclosure after injection of a first composition;

[0026] FIG5 is a schematic diagram of a gravel extraction system provided by an embodiment of the present disclosure after injection of a second composition;

[0027] FIG6 is a schematic diagram of an elastic hydrogel formed after the second composition reacts with the first composition;

[0028] FIG7 is a schematic diagram of using the gravel extraction system provided by an embodiment of the present disclosure to pull out an elastic hydrogel;

[0029] FIG8 is a schematic structural diagram of a gravel extraction system provided in yet another embodiment of the present disclosure.

[0030] The figure numbers in the specific embodiment are as follows: stone crusher extraction system 100, conveying device 110, accommodating portion 111, first carrier 1111, second carrier 1112, catheter 112, first injection cavity 1121, second injection cavity 1122, bell mouth 113, first composition 121, second composition 122, elastic hydrogel 123, stone crusher 200, smaller stone fragments 201, larger stone fragments 202. DETAILED DESCRIPTION

[0031] To make the objectives, technical solutions, and advantages of the present invention more apparent, the present invention will be further described in detail below with reference to the accompanying drawings. It is apparent that the embodiments described are only some, not all, of the present invention. All other embodiments derived by persons of ordinary skill in the art based on the embodiments of the present invention without creative effort are intended to fall within the scope of protection of the present invention.

[0032] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. The terms used herein are only for the purpose of describing specific embodiments and are not intended to limit this disclosure.

[0033] It should also be noted that the terms "include," "comprises," or any other variations thereof are intended to encompass non-exclusive inclusion, such that a product or device comprising a series of elements includes not only those elements but also other elements not explicitly listed, or elements inherent to such product or device. In the absence of further limitations, an element defined by the phrase "comprising a" does not exclude the presence of other identical elements in the product or device comprising the element.

[0034] In the description of the embodiments of the present invention, the orientations or positional relationships indicated by technical terms such as "upper", "lower", and "thickness" are based on the orientations or positional relationships shown in the accompanying drawings. They are only for the convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operate in a specific orientation. Therefore, they cannot be understood as limitations on the embodiments of the present invention.

[0035] In the description of the embodiments of the present invention, the term "and / or" is simply a description of the association relationship between associated objects, indicating that three relationships can exist. For example, A and / or B can represent the following three situations: A exists alone, A and B exists simultaneously, and B exists alone. In addition, the character " / " in this document generally indicates that the associated objects are in an "or" relationship.

[0036] In the description of the embodiments of the present invention, the symbol “~” represents the two endpoint data before and after the “~” and all data between the two endpoints. For example, A~B represents all data greater than or equal to A and less than or equal to B.

[0037] References to "embodiments" in this disclosure mean that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the disclosure. The appearance of this phrase in various places in the specification does not necessarily refer to the same embodiment, nor does it constitute an independent or alternative embodiment that is mutually exclusive of other embodiments. It is understood, both explicitly and implicitly, by those skilled in the art that the embodiments described in this disclosure may be combined with other embodiments.

[0038] As mentioned in the background art, existing surgical instruments are unable to completely remove stones during surgery, especially small stones. Relevant studies have shown that after flexible ureteroscopy, the residual rates of stones <3mm, <2mm, and <1mm are 10-15%, 16.1%, and 86%, respectively. Therefore, patients often require postoperative assistance with the spontaneous expulsion of residual stones through methods such as increased hydration, medication, special body positioning, and external physical vibration stone removal. However, during spontaneous stone removal, hematuria, pain, and increased stone burden are common. For example, external physical vibration stone removal is a common intervention to assist in the expulsion of residual stones after flexible ureteroscopy. This involves transmitting external physical vibrations to the kidney area to generate a certain amount of vibration, promoting the displacement of residual stones within the kidney and facilitating their spontaneous expulsion. However, while external physical vibration stone removal increases the stone expulsion rate, it also increases complications such as hematuria, renal colic, and dizziness caused by the stone removal machine.

[0039] In response to the above problems, one aspect of an embodiment of the present application provides a gravel extraction system, comprising a conveying device and a hydrogel, wherein the hydrogel comprises a first composition and a second composition, the first composition comprising at least one cross-linkable polymer, the second composition comprising at least one cross-linking agent, the cross-linkable polymer being configured to wrap the gravel after being conveyed to the gravel position by the conveying device, and the cross-linking agent being configured to react with the cross-linkable polymer to form an elastic hydrogel body wrapping the gravel after being conveyed to the gravel position by the conveying device; wherein the cross-linkable polymer and the cross-linking agent are sterilized with high-pressure steam before forming the hydrogel, and the viscosity of the cross-linkable polymer is less than 100cp; the conveying device is configured to remove the gravel after adsorbing the elastic hydrogel body.

[0040] As can be seen, the lithotripsy system provided in the embodiments of the present application forms an elastic hydrogel body that encapsulates small stones or stone fragments (hereinafter collectively referred to as lithotripsy). By extracting the elastic hydrogel body, the encapsulated lithotripsy is also extracted, thereby resolving the current clinical challenge of being unable to cleanly remove small, fine stones, reducing patient pain and the likelihood of secondary surgery. The elastic hydrogel body formed by the lithotripsy system described in the present application can encapsulate multiple lithotripsy, allowing multiple or even all lithotripsy to be removed at once through a single instrument channel, eliminating the need for instrument replacement, reducing surgical time, and alleviating patient pain.

[0041] 1 , an embodiment of the present application provides a gravel extraction system 100, comprising a conveying device 110 and a hydrogel, wherein the hydrogel comprises a first composition 121 and a second composition 122, wherein the first composition 121 comprises at least one cross-linkable polymer, and the second composition 122 comprises at least one cross-linking agent, wherein the cross-linkable polymer is configured to wrap the gravel 200 after being conveyed to the position of the gravel 200 by the conveying device 110, and the cross-linking agent is configured to undergo a cross-linking reaction with the cross-linkable polymer after being conveyed to the position of the gravel 200 by the conveying device 110 to form an elastic hydrogel body 123 wrapping the gravel 200; the conveying device 110 is configured to remove the gravel 200 after adsorbing the elastic hydrogel body 123.

[0042] The gravel 200 can be a small stone or a fragment formed by crushing a larger stone. Referring to Figure 2, when the stone is crushed, for example, by a laser, the larger stone fragments 202 can be removed by conventional technology, and the remaining smaller stone fragments 201, such as stone fragments with a size of less than 3 mm, cannot be removed by conventional instruments and methods. The above-mentioned smaller stone fragments 201 can be removed using the gravel extraction system 100 provided in the embodiment of the present application.

[0043] In some embodiments, the conveying device 110 includes a receiving portion 111 and a conduit 112 , wherein the conduit 112 is connected to the receiving portion 111 . After the first composition 121 and the second composition 122 are placed in the receiving portion 111 , they can be successively conveyed to the gravel 200 through the conduit 112 .

[0044] In some embodiments, referring to FIG3 , the end of the catheter 112 further comprises a bell-shaped opening 113. For example, the tip of the bell-shaped opening 113 can be expanded by heat-treating the distal end of the catheter 112. Forming the bell-shaped opening 113 at the end of the catheter 112 facilitates the absorption of the elastic hydrogel, as shown in FIG3( a). The bell-shaped opening 113 can be formed of a memory material or a flexible material, making it easier to pass through the lumen of an endoscope, as shown in FIG3( b).

[0045] The hydrogel includes a first composition 121 and a second composition 122. The first composition 121 includes at least one cross-linkable polymer, and the second composition 122 includes at least one cross-linking agent.

[0046] 4 , the first composition 121 is configured to be delivered to the gravel 200 via the delivery device 110 and then wrap around the gravel 200. In some embodiments, the delivery device 110 is used in conjunction with an endoscope system, and the first composition 121 is injected through the delivery device 110 under endoscopy, so that the first composition 121 reaches the gravel 200 and flows around the gravel 200.

[0047] The first composition 121 can be a multi-component composition comprising one or more cross-linkable polymers. In some embodiments, the first composition 121 is a two-component composition comprising at least one cross-linkable polymer. In some embodiments, the cross-linkable polymer is a cationic cross-linkable polymer. In some embodiments, the cross-linkable polymer comprises sodium alginate, and the cross-linking agent comprises calcium chloride. The molecular weight of at least 40% of the sodium alginate is in the range of 110,000-500,000. As an optional example, the molecular weight of at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, at least 90%, or at least 99% of the sodium alginate is in the range of at least 110,000, at least 150,000, at least 200,000, at least 250,000, at least 300,000, at least 350,000, at least 400,000, at least 450,000, or at least 500,000.

[0048] In some embodiments, the sodium alginate is a polysaccharide composed of guluronic acid and mannuronic acid. The ratio of guluronic acid to mannuronic acid in the alginate molecule can vary within a certain range, wherein the ratio of guluronic acid determines the ratio of mannuronic acid. For example, if the ratio of guluronic acid is 75%, the ratio of mannuronic acid is 25%. The content of guluronic acid in the sodium alginate can range from 30% to 95%. As an alternative example, the content of guluronic acid can be at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 60%, at least 65%, at least 70%, at least 75%, at least 80%, at least 85%, at least 90%, or at least 95%.

[0049] In some embodiments, the cross-linkable polymer and the cross-linking agent are sterilized before forming the hydrogel, and the sterilization method is high-pressure steam sterilization.

[0050] If the crosslinkable polymer and the crosslinking agent are sterilized using ethylene oxide, ethylene oxide gas dissolves in water and produces toxic gases that are harmful to human health. If the crosslinkable polymer and the crosslinking agent are sterilized using irradiation, irradiation sterilization will excessively reduce the strength of the hydrogel, making it unable to meet usage requirements. Therefore, high-pressure steam sterilization is selected as the product sterilization process.

[0051] During high-pressure steam sterilization, the concentration of the solution, the steam sterilization temperature, and the steam sterilization time all have a significant and direct impact on the final product effect. Table 1, taking sodium alginate solution as an example, shows the effect of high-pressure steam sterilization temperature and steam sterilization time on the viscosity of the sodium alginate solution.

[0052] Table 1

[0053] As can be seen from Table 1, the higher the viscosity of the sodium alginate solution, the higher the final viscosity of the solution after high-temperature sterilization; the longer the sterilization time, the lower the final viscosity of the solution after high-temperature sterilization.

[0054] In some embodiments, the viscosity of the cross-linkable polymer after sterilization is less than 100 cp. Specifically, the viscosity of the cross-linkable polymer after sterilization is in the range of 75±10 cp.

[0055] In some embodiments, the high-pressure steam sterilization time is 5-30 minutes, and the sterilization temperature is greater than 120° C. In some embodiments, the cross-linkable polymer is a sodium alginate solution, and the concentration of the sodium alginate is 0.5%-1.5%.

[0056] 5 , the second composition 122 is configured to be delivered to the location of the gravel 200 via the delivery device 110, where it reacts with the cross-linkable polymer to form an elastic hydrogel 123 that wraps the gravel 200. In some embodiments, the delivery device 110 is used in conjunction with an endoscope system, and the second composition 122 is injected through the delivery device 110 under endoscopy.

[0057] 6 , the second composition 122 can undergo a cross-linking reaction with the first composition 121 to form a continuous elastic hydrogel 123 that encapsulates the gravel 200. The elastic hydrogel 123 can encapsulate any remaining gravel 200. The elastic hydrogel 123 encapsulating the gravel 200 can then be removed from the body via the delivery device 110. The second composition 122 can rapidly solidify with the first composition 121 to form a continuous elastic hydrogel 123, which can be rapidly solidified in, for example, the ureter or kidney.

[0058] 7 , the specific operation of removing the elastic hydrogel body 123 is as follows: after the hydrogel injection is completed, the hydrogel wraps around the gravel 200 to form the hydrogel body 123. The bell mouth 113 of the conveying device 110 is pressed against the elastic hydrogel body 123. A negative pressure suction force is applied to the conveying device 110, so that the inside of the catheter 112 of the conveying device 110 is in a negative pressure state. The bell mouth 113 can absorb the elastic hydrogel body 123 wrapping the gravel 200. When the catheter 112 is removed, the elastic hydrogel body 123 is also taken out.

[0059] The second composition 122 may be a multi-component composition comprising one or more crosslinking agents capable of reacting with the crosslinkable polymer to form an elastic hydrogel 123 that encapsulates the gravel 200. In some embodiments, the second composition 122 may be an aqueous solution of barium chloride, an aqueous solution of strontium chloride, or an aqueous solution of calcium chloride.

[0060] In some embodiments, the cross-linkable polymer in the first composition 121 includes a sodium alginate solution, and the cross-linking agent in the second composition 122 includes calcium chloride, wherein the concentration of the calcium chloride may be 2.0%-10%.

[0061] The components and concentrations of the second composition 122 can be determined based on the first composition 121. For example, after determining the viscosity of the sodium alginate solution (75±10cp), the effect of the final gel can be tested by using calcium chloride solutions of different concentrations. Table 2 shows the corresponding pull-out effects of calcium chloride solutions of different concentrations when the final viscosity of the sodium alginate solution is 72cp, wherein calcium chloride solutions of 2.0%, 4.0%, 6.0%, 8.0%, and 10.0% concentrations are selected to verify the hydrogel effect, and the number of times the entire gel can be pulled out is used as the basis for judgment. The test environment is a 39°C constant temperature water bath, 60ml of normal saline, and in vitro experiments.

[0062] Table 2

[0063] As shown in Table 2, a 6.0% calcium chloride solution has the best gripping efficiency, allowing complete removal from the body in an average of four attempts. When the calcium chloride solution concentration is too low, the cross-linking reaction cannot be achieved, resulting in a gel that is too soft and easily breaks when the basket is grasped, making it impossible to fully grasp the gel. When the calcium chloride solution concentration is too high, the gel becomes too hard, and the gripping efficiency does not improve.

[0064] Table 3 shows multiple grabbing experiments of 6.0% calcium chloride solution when the final viscosity of the sodium alginate solution is 72 cp. The test environment is a 39°C constant temperature water bath with 60 ml of normal saline, and the in vitro experiment is conducted in pig large intestine tissue.

[0065] Table 3

[0066] As can be seen from Table 3, in the simulated tissue experiment product, the gel encapsulating the stones in the pig large intestine tissue can be successfully removed from the body through an endoscope. In some embodiments, the first composition 121 further comprises at least one dye. In some embodiments, the second composition 122 further comprises at least one dye. The color of the dye contained in the first composition 121 is different from the color of the dye contained in the second composition 122, so as to facilitate the distinction between the first composition 121 and the second composition 122 during operation. For example, the dye contained in the first composition 121 is bright blue powder, and the dye contained in the second composition 122 is lemon yellow powder.

[0067] 1 and 8 , in some embodiments, the container 111 further includes a first carrier 1111 and a second carrier 1112. The first carrier 1111 is used to accommodate the first composition 121 and is detachably connected to the conduit 112, thereby transporting the accommodated first composition 121 to the gravel 200 via the conduit 112. The second carrier 1112 is used to accommodate the second composition 122 and is detachably connected to the conduit 112, thereby transporting the accommodated second composition 122 to the gravel 200 via the conduit 112. Among them, the embodiment shown in Figure 1 is that the first carrier 1111 and the second carrier 1112 are separate structures, and the first composition 121 and the second composition 122 can be transported to the gravel 200 position respectively in sequence; the embodiment shown in Figure 8 is that the first carrier 1111 and the second carrier 1112 are connected structures, and the first composition 121 and the second composition 122 can be transported to the gravel 200 position at the same time.

[0068] In some embodiments, the first carrier 1111 and the second carrier 1112 comprise a syringe with a small hole at the front end and a piston core rod that matches the syringe. When the piston core rod is withdrawn, liquid or gas is drawn in through the small hole at the front end of the syringe, and when the piston core rod is pushed in, the liquid or gas is expelled from the small hole at the front end of the syringe. The first carrier 1111 and the second carrier 1112 can be used to extract the corresponding first composition 121 and the second composition 122, and to inject the first composition 121 and the second composition 122 into the catheter 112.

[0069] In some embodiments, referring to FIG8 , the accommodating portion 111 further includes a first carrier 1111, a second carrier 1112, a synchronous fixing plate 1113, and a synchronous boosting plate 1114. The first carrier 1111 is used to accommodate the first composition 121, and the first carrier 1111 is detachably connected to the conduit 112, and then the accommodated first composition 121 is transported to the gravel 200 position through the conduit 112; the second carrier 1112 is used to accommodate the second composition 122, and the second carrier 1112 is detachably connected to the conduit 112, and then the accommodated second composition 122 is transported to the gravel 200 position through the conduit 112; the synchronous fixing plate 1113 is sleeved on the outside of the first carrier 1111 and the second carrier 1112, and the synchronous fixing plate 1113 is connected to the first carrier 1111 and the second carrier 1112 at the same time. Specifically, the synchronous fixing plate 1113 is provided on the outside of the first carrier 1111 and the second carrier 1112. The fixed plate 1113 is respectively connected to the syringes of the first carrier 1111 and the second carrier 1112 to fix the syringes of the first carrier 1111 and the second carrier 1112, so that the syringes of the first carrier 1111 and the second carrier 1112 are connected to each other to form a whole without relative displacement; the synchronous booster plate 1114 is respectively connected to the piston core rods of the first carrier 1111 and the second carrier 1112, and the synchronous booster plate 1114 can be set at the rod tail part of the piston core rod of the first carrier 1111 and the second carrier 1112, so that the piston core rods of the first carrier 1111 and the second carrier 1112 are connected to each other to form a whole without relative displacement. During operation, the delivery device 110 applies a thrust to the synchronous boosting plate 1114, causing it to move relative to the synchronous fixing plate 1113. This thrust drives the piston core rods of the first and second carriers 1111, 1112, pushing them into the syringes of the first and second carriers 1111, 1112. During this process, the first composition 121 in the first carrier 1111 and the second composition 122 in the second carrier 1112 are synchronously injected into the target location, forming the elastic hydrogel 123.

[0070] In some embodiments, the conduit 112 is formed of a flexible material, allowing the conduit 112 to bend to a certain degree as needed, and having a certain strength, not easily bent or broken, and can smoothly enter the endoscope instrument channel. The hardness of the flexible material can range from 68D to 76D, for example, 72D.

[0071] In some embodiments, the material of the catheter 112 can be polyether block polyamide (PEBAX) material. The PEBAX material has the characteristics of good toughness, not easy to bend, and tempered inner wall. Compared with PTFE material catheters, the PEBAX material catheter is less likely to deform under the premise of good toughness. Compared with PE material catheters, the PEBAX material catheter is less likely to bend.

[0072] In some embodiments, the catheter 112 further includes a first injection cavity 1121 and a second injection cavity 1122, wherein the first injection cavity 1121 is connected to the first carrier 1111, and the second injection cavity 1122 is connected to the second carrier 1112, so that the first composition 121 and the second composition 122 have corresponding injection cavities, preventing the first composition 121 and the second composition 122 from mixing prematurely in the cavity.

[0073] In some embodiments, the lithotripsy extraction system 100 needs to be used in conjunction with an electronic endoscope. The selection of the catheter 112 needs to take into account the parameters of the electronic endoscope instrument channel. Specifically, the outer diameter of the catheter 112 needs to be smaller than the instrument channel of the electronic endoscope. For example, if the instrument channel of the electronic endoscope is 1.2 mm, the outer diameter of the catheter 112 needs to be less than 1.2 mm. At the same time, considering the passability of the catheter 112 in the instrument channel, the inner diameter of the catheter 112 is determined to be 1.00 mm ± 0.05 mm. And if the strength, toughness and liquid pass rate of the catheter 112 are taken into account, the inner diameter of the catheter 112 can be selected to be 0.60 mm to 0.80 mm. The working length of the catheter 112 can be 1300 mm.

[0074] As an example, if the lithotripsy extraction system 100 provided in this embodiment is used to extract lithotripsy from the kidney, according to relevant literature, the normal human renal pelvis volume is 5ml to 11ml. If a 3ml self-locking syringe is used as a carrier for the hydrogel, 3ml of each of the first composition 121 and the second composition 122 is measured. When using a catheter 112 with an outer diameter of 1.00mm and an inner diameter of 0.80mm for syringe push injection, the injection pressure of the 3ml syringe is approximately 7N. Manual push injection can be used.

[0075] Furthermore, the embodiment of the present application also discloses a method for extracting gravel using the gravel extraction system 100 .

[0076] The gravel extraction system 100 includes a conveying device 110 and a hydrogel, wherein the hydrogel includes a first composition 121 and a second composition 122, the first composition 121 includes at least one cross-linkable polymer, and the second composition 122 includes at least one cross-linking agent, the cross-linkable polymer is configured to wrap the gravel 200 after being conveyed to the position of the gravel 200 by the conveying device 110, and the cross-linking agent is configured to react with the cross-linkable polymer after being conveyed to the position of the gravel 200 by the conveying device 110 to form an elastic hydrogel body 123 that wraps the gravel 200; the conveying device 110 is configured to absorb the elastic hydrogel body 123 and then remove the gravel 200.

[0077] The conveying device 110 includes a receiving portion 111 and a conduit 112 . The conduit 112 is connected to the receiving portion 111 . After the first composition 121 and the second composition 122 are placed in the receiving portion 111 , they can be successively conveyed to the gravel 200 through the conduit 112 .

[0078] The receiving portion 111 further includes a first carrier 1111 and a second carrier 1112. The first carrier 1111 is used to receive a first composition 121 and is detachably connected to the conduit 112, thereby transporting the received first composition 121 to the gravel 200 through the conduit 112. The second carrier 1112 is used to receive a second composition 122 and is detachably connected to the conduit 112, thereby transporting the received second composition 122 to the gravel 200 through the conduit 112.

[0079] The method for extracting gravel using the gravel extraction system 100 includes:

[0080] S10, respectively preparing a first composition 121 solution and a second composition 121 solution, placing the first composition 121 solution into a first carrier 1111, and placing the second composition 121 solution into a first carrier 1112;

[0081] S20, using the first carrier 1111 to inject a predetermined volume of the first composition 121 solution into a target area containing the gravel 200 to be extracted;

[0082] S30, using the second carrier 1112 to inject a predetermined volume of the second composition 121 solution into a target area containing the gravel 200 to be extracted, and waiting for a preset time to allow the second composition 121 to undergo a cross-linking reaction with the first composition 121;

[0083] S40, the free end of the catheter 112 is brought close to the elastic hydrogel body 123, and negative pressure suction is applied to the delivery device 110 to put the inside of the catheter 112 in a negative pressure state, and the catheter 112 is removed outward, and the elastic hydrogel body 123 is removed along with the catheter 112.

[0084] In some embodiments, the preset time is greater than or equal to 5 seconds.

[0085] In some embodiments, applying negative pressure suction to the delivery device 110 includes: deflating a self-locking syringe, connecting it to the catheter 112, and pulling the plunger of the syringe to a predetermined nominal scale to lock it. In some embodiments, the predetermined nominal scale of the syringe is 10 ml.

[0086] In some embodiments, the catheter 112 is sleeved in an endoscope instrument channel, and the endoscope is removed outward so that the catheter 112 and the elastic hydrogel 123 adsorbed by the free end of the catheter 112 are removed together.

[0087] This application also further studies the degradation of the hydrogel in vitro to verify the safety of its use environment. The verification method is: prepare a solid hydrogel and cut it into 3mm fragments with a die knife for use. Place the gel fragments in a container, cover and seal the container with the test solution, maintain a suitable temperature, and simulate a physiological environment. At different cycles of the test, the test solution is filtered using a 35-mesh 0.5mm stainless steel mesh to observe whether there is any gel residue on the filter. It is understood that clinically, ureteral stents are placed in the human body for 2-4 weeks after soft endoscopic lithotomy. The minimum specification is 4.7F, the minimum inner diameter of the ureteral stent is 1.00±0.05mm, and the openings at both ends of the ureteral stent are 0.8mm in diameter. Therefore, a 35-mesh 0.5mm stainless steel mesh is selected. After the test solution is sieved, no gel remains on the mesh, which proves that the gel will not block the ureteral stent.

[0088] This application also further studies the hydrolysis / dissolution properties of related materials. The specific process is:

[0089] 1. Use a 3ml syringe to take 1ml of sodium alginate solution in the center of the glass dish. Then use a 5ml syringe to take 3ml of calcium chloride solution and inject it around the sodium alginate solution. Wait for 5 minutes at room temperature until the sodium alginate and calcium chloride cross-link to form a gel. Use tweezers to remove the gel and place it in a new glass dish.

[0090] 2. Use a 3mm die cutter to accurately cut 3mm gel fragments. Use tweezers to transfer the cut gel fragments to a reagent bottle, placing every 6 gel pieces in a reagent bottle, for a total of 5 bottles. Set it as Group A, and prepare 4 groups B, C, and D in the same way. Add 10ml of artificial urine with a pH of 8.0 to each sample in Group A, add 10ml of artificial urine with a pH of 6.5 to each sample in Group B, add 10ml of artificial urine with a pH of 5.0 to each sample in Group C, and add 10ml of normal saline (pH = 6.9 ± 0.3) to each sample in Group D.

[0091] Each group of samples was stored in a constant temperature box at 37°C, taken out at a fixed time point, filtered through a mesh, and the gel dissolution was checked. After filtration, new test solution was replaced until the gel was completely dissolved, and the data was recorded.

[0092] Evaluation of the experimental data from the above process: Comparison of pre- and post-degradation data and results was performed to assess the degradation trend of calcium alginate. Five groups of samples (six 3mm gel fragments per group) were immersed in 10ml of normal saline (pH = 6.9 ± 0.3) and artificial urine at different pH values. The degree of sample dissolution was measured at fixed time points, and the presence of gel fragments remaining on the stainless steel mesh was observed. The experimental data is shown in Table 4.

[0093] Table 4

[0094] Calcium alginate is a pH-sensitive hydrogel with very high pH requirements. It is relatively stable in acidic media and is not easy to swell or dissolve, but is soluble in alkaline media. The experimental data in Table 4 show that: 1) Calcium alginate dissolves fastest in artificial urine with a pH of 8. Gel fragments of approximately 3 mm were dissolved in 1 hour for 4 groups of samples and 2 hours for 1 group of samples. The remaining gel of the sample that had not dissolved after 1 hour is shown in Figure 1; 2) In artificial urine with a pH of 6.5, gel fragments of approximately 3 mm were dissolved after 2 hours; 3) In artificial urine with a pH of 5.0, gel fragments of approximately 3 mm were dissolved in 2 hours for 2 groups of samples and 3 hours for 3 groups of samples; 4) In physiological saline with a pH of approximately 6.9, calcium alginate dissolves slowest. Gel fragments of approximately 3 mm were dissolved in 3 hours for all 5 groups of samples.

[0095] The above experiments show that calcium alginate hydrogel, formed by the complexation of sodium alginate and calcium chloride through an ion exchange reaction, is a pH-sensitive hydrogel. It is relatively stable in an acidic environment and has a slow dissolution rate. It is soluble under alkaline conditions and has a faster dissolution rate. It is most stable in a neutral environment, but can still degrade slowly. Gel fragments of about 3 mm in size can be completely dissolved in urine and saline in about 3 hours. The degradation of alginate hydrogel is carried out by hydrolysis or enzymatic hydrolysis. Under the action of water molecules, the network structure of the alginate hydrogel gradually loosens, causing the physical properties of the hydrogel to change, and eventually decomposing into monomers or small molecules. Therefore, it can be seen that if there is any residue during stone removal, the human body can dissolve it on its own and will not cause too much harm to the human body.

[0096] This application further provides the following examples and comparative examples.

[0097] Example 1

[0098] (1) preparing a sodium alginate aqueous solution A with a concentration of 1.5% and a brilliant blue powder concentration of 0.001%, the pH value of which is about 7.8; preparing anhydrous calcium chloride with a concentration of 6.0% and a lemon yellow powder concentration of 0.003% and a calcium chloride aqueous solution B with a pH value of about 4.6; sterilizing the sodium alginate solution with moist heat to obtain a final viscosity of 72 cp;

[0099] (2) Prepare a 1.0*0.8 mm, 1300 mm long PEBAX delivery system catheter;

[0100] (3) The simulated kidney was continuously infused with normal saline at a flow rate of 2.0 mL / min;

[0101] (4) Using a 10 ml syringe, inject 0.5 ml of solution A through the delivery system into the simulated kidney area containing the kidney stone fragments to be removed;

[0102] (5) Using a 10 ml syringe, inject 1.5 ml of solution B through the delivery system into the area described in step (3) to cause a cross-linking reaction;

[0103] (6) Prepare a three-claw basket to grab the gel through the urinary tract sheath;

[0104] (7) Remove the gel that encapsulates the stone fragments while removing the ureteroscope outward.

[0105] Example 2

[0106] (1) preparing a sodium alginate aqueous solution with a concentration of 1.0% and a brilliant blue powder concentration of 0.001%, the pH value of which is about 7.8; preparing anhydrous calcium chloride with a concentration of 6.0% and a lemon yellow powder concentration of 0.003% and a calcium chloride aqueous solution with a pH value of about 4.6; sterilizing the sodium alginate solution with moist heat to obtain a final viscosity of 72 cp;

[0107] (2) Prepare a 1.0*0.8 mm, 1300 mm long PEBAX delivery system catheter;

[0108] (3) The simulated kidney was continuously infused with normal saline at a flow rate of 2.0 mL / min;

[0109] (4) Using a 10 ml syringe, inject 0.5 ml of solution A through the delivery system into the simulated kidney area containing the kidney stone fragments to be removed;

[0110] (5) Using a 10 ml syringe, inject 1.5 ml of solution B through the delivery system into the area next to the step (3) to cause a cross-linking reaction;

[0111] (6) Prepare a three-claw basket to grab the gel through the urinary tract sheath;

[0112] (7) Remove the gel that encapsulates the stone fragments while removing the ureteroscope outward.

[0113] Comparative Example 1

[0114] (1) preparing a sodium alginate aqueous solution A with a concentration of 1.5% and a brilliant blue powder concentration of 0.001%, the pH value of which is about 7.8; preparing anhydrous calcium chloride with a concentration of 6.0% and a lemon yellow powder concentration of 0.003% and a calcium chloride aqueous solution B with a pH value of about 4.6; sterilizing the sodium alginate solution with moist heat to obtain a final viscosity of 200 cp;

[0115] (2) Prepare a 1.0*0.8 mm, 1300 mm long PEBAX delivery system catheter;

[0116] (3) The simulated kidney was continuously infused with normal saline at a flow rate of 2.0 mL / min;

[0117] (4) Use a 10 ml syringe to inject 1.0 ml of Solution A through the delivery system into the simulated kidney area containing the kidney stone fragments to be removed.

[0118] In this comparative example, in step (4), the syringe was manually pushed, but the pushing force was too great to achieve injection, and the experiment was terminated.

[0119] Comparative Example 2

[0120] (1) preparing a sodium alginate aqueous solution A with a concentration of 1.5% and a brilliant blue powder concentration of 0.001%, the pH value of which is about 7.8; preparing anhydrous calcium chloride with a concentration of 2.0% and a lemon yellow powder concentration of 0.003% and a calcium chloride aqueous solution B with a pH value of about 6.7; sterilizing the sodium alginate solution with moist heat to obtain a final viscosity of 72 cp;

[0121] (2) Prepare a 1.0*0.8 mm, 1300 mm long PEBAX delivery system catheter;

[0122] (3) The simulated kidney was continuously infused with normal saline at a flow rate of 2.0 mL / min;

[0123] (4) Using a 10 ml syringe, inject 0.5 ml of solution A through the delivery system into the simulated kidney area containing the kidney stone fragments to be removed;

[0124] (5) Using a 10 ml syringe, inject 1.5 ml of solution B through the delivery system into the area next to the step (3) to cause a cross-linking reaction;

[0125] (6) Prepare a three-claw basket to grab the gel through the urinary tract sheath;

[0126] In this comparative example, the formed gel has poor strength and cannot be grasped using a mesh basket. The gel has poor wrapping properties for the stones, and the grasping process will cause the stones to separate from the gel, making it impossible to remove the stones from the body.

[0127] Compared to the existing technology, the lithotripsy system provided in the embodiments of the present application forms an elastic hydrogel body that encapsulates small stones or stone fragments (hereinafter collectively referred to as lithotripsy). By extracting the elastic hydrogel body, the encapsulated lithotripsy is also extracted, thereby resolving the current clinical challenge of being unable to cleanly remove small, fine stones, reducing patient pain and the likelihood of secondary surgery. The elastic hydrogel body formed by the lithotripsy system described in the present application can encapsulate multiple lithotripsy, allowing multiple or even all lithotripsy to be removed at once through a single instrument channel, eliminating the need for instrument replacement, reducing surgical time, and alleviating patient pain.

[0128] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present disclosure, rather than to limit them. Although the present disclosure has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some or all of the technical features therein. These modifications or replacements do not deviate the essence of the corresponding technical solutions from the scope of the technical solutions of the embodiments of the present disclosure, and they should all be included in the scope of the claims and specification of the present disclosure. In particular, as long as there is no structural conflict, the various technical features mentioned in the various embodiments can be combined in any way. The present disclosure is not limited to the specific embodiments disclosed herein, but includes all technical solutions that fall within the scope of the claims.

Claims

1. A gravel extraction system, characterized in that, It includes a conveying device and a hydrogel. Among them, the hydrogel includes a first composition and a second composition. The first composition contains at least one crosslinkable polymer, and the second composition contains at least one crosslinking agent. The crosslinkable polymer is configured to wrap the crushed stones after being conveyed to the crushed stone position by the conveying device. The crosslinking agent is configured to react with the crosslinkable polymer after being conveyed to the crushed stone position by the conveying device to form an elastic hydrogel body that wraps the crushed stones. Among them, the crosslinkable polymer and the crosslinking agent are sterilized by high-pressure steam before forming the hydrogel, and the viscosity of the crosslinkable polymer is less than 100 cp; the conveying device is configured to adsorb the elastic hydrogel body and then take out the crushed stones.

2. The gravel extraction system according to claim 1, characterized in that, The first composition further contains at least one dye, and / or the second composition further contains at least one dye.

3. The gravel extraction system according to claim 1, characterized in that The crosslinkable polymer is a cationic crosslinkable polymer.

4. The gravel extraction system according to claim 1, characterized in that The crosslinkable polymer includes sodium alginate, and the crosslinking agent includes calcium chloride.

5. The gravel extraction system according to claim 4, characterized in that, The concentration of the sodium alginate is 0.5%-1.5%, the time of high-pressure steam sterilization is 5-30 minutes, and the sterilization temperature is greater than 120 °C.

6. The gravel extraction system according to claim 4, characterized in that, The concentration of the calcium chloride is 2.0%-10%.

7. The gravel extraction system according to claim 4, characterized in that, The molecular weight of at least 40% of the sodium alginate ranges from 110,000 to 500,000; the sodium alginate is a polysaccharide composed of guluronic acid and mannuronic acid; the content of guluronic acid in the sodium alginate is 30%-95%.

8. The gravel extraction system according to claim 7, wherein The conveying device includes a containing part and a catheter. The catheter is communicated with the containing part. After the first composition and the second composition are placed in the containing part, they are successively conveyed to the crushed stone position through the catheter.

9. The gravel extraction system according to claim 8, characterized in that, The catheter is formed of a flexible material, and the hardness of the flexible material is 72D.

10. The gravel extraction system according to claim 8, characterized in that, The end of the catheter forms a flared opening, and the flared opening is formed of a memory material or a flexible material.

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