CN117883148A - Broken stone extraction system - Google Patents
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- CN117883148A CN117883148A CN202410063937.7A CN202410063937A CN117883148A CN 117883148 A CN117883148 A CN 117883148A CN 202410063937 A CN202410063937 A CN 202410063937A CN 117883148 A CN117883148 A CN 117883148A
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Abstract
The present disclosure provides a lithotripsy extraction system comprising a delivery device and a hydrogel, wherein the hydrogel comprises a first composition comprising at least one crosslinkable polymer and a second composition comprising at least one crosslinking agent configured to encapsulate the lithotripsy after delivery to a lithotripsy location via the delivery device, the crosslinking agent configured to react with the crosslinkable polymer to form an elastomeric hydrogel body encapsulating the lithotripsy after delivery to the lithotripsy location via the delivery device; the delivery device is configured to remove the crushed stone after the elastic hydrogel body is adsorbed. The present disclosure can remove a plurality of even all fine crushed stones which cannot be removed by conventional means at one time, reducing the pain of patients.
Description
Technical Field
The present disclosure relates to the field of medical technology, and in particular, to a lithotripsy extraction system.
Background
Stones (lithiasis) are solid masses formed in the lumen of a catheter or in the lumen of a luminal organ (e.g., kidney, ureter, gall bladder, etc.) within a human or animal body. It is mainly found in the gall bladder, bladder and renal pelvis, but also in the lumens of pancreatic ducts, salivary ducts, etc. Stones can cause severe pain, for example, kidney stones can cause kidney inflammation and even lead to (usually unilateral) acute renal failure. At present, stones are mainly extracted through a minimally invasive operation mode, for example, kidney stones mainly comprise ureteroscope lithotripsy stone extraction (RIRS), percutaneous nephroscope lithotripsy stone extraction (PCNL), double-lens combined lithotripsy stone extraction (PCNL + RIRS), laparoscope, robot-assisted laparoscopic incision stone extraction and the like. However, due to limitations of surgical instruments and the like, stones, particularly some fine stones, cannot be completely removed during surgery. After operation, the patient needs to be assisted in self-discharging of residual stones by means of adding drinking water, medicines, special body positions, external physical vibration, stone discharging and the like, and the patient is very inconvenient and has the risk of secondary operation.
Disclosure of Invention
In view of the above technical problems, the present disclosure provides a crushed stone extraction system, which solves at least one technical problem existing in the prior art.
According to a first aspect of the present disclosure, there is provided a lithotripsy extraction system comprising a delivery device and a hydrogel, wherein,
The hydrogel comprises a first composition comprising at least one crosslinkable polymer and a second composition comprising at least one crosslinking agent configured to encapsulate the crushed stone after delivery to a crushed stone location via the delivery device, the crosslinking agent configured to react with the crosslinkable polymer to form an elastomeric hydrogel body encapsulating the crushed stone after delivery to a crushed stone location via the delivery device; wherein the crosslinkable polymer and the crosslinking agent are autoclaved prior to forming the hydrogel, the crosslinkable polymer having a viscosity of less than 100cp;
the delivery device is configured to remove the crushed stone after the elastic hydrogel body is adsorbed.
Optionally, the first composition further comprises at least one dye, and/or the second composition further comprises at least one dye.
Optionally, the crosslinkable polymer is a cationic crosslinkable polymer.
Optionally, the crosslinkable polymer comprises sodium alginate and the crosslinking agent comprises calcium chloride.
Optionally, the concentration of the sodium alginate is 0.5% -1.5%, the high-pressure steam sterilization time is 5-30 minutes, and the sterilization temperature is more than 120 ℃.
Optionally, the concentration of the calcium chloride is 2.0% -10%.
Optionally, the molecular weight of at least 40% of the sodium alginate is in the range of 110000-500000; the sodium alginate is a polysaccharide consisting of ancient Lu Tangsuan and mannonic acid; the content of Gu Lutang acid in the sodium alginate is 30% -95%.
Optionally, the conveying device comprises a containing part and a conduit, the conduit is communicated with the containing part, and the first composition and the second composition are conveyed to the stone crushing position through the conduit after being placed in the containing part.
Optionally, the catheter is formed of a flexible material having a durometer of 72D.
Optionally, the end of the conduit forms a flare formed from a memory material or a flexible material.
Compared with the prior art, the scheme of the embodiment of the disclosure has at least the following beneficial effects:
According to the lithotriptic extraction system provided by the embodiment of the application, the elastic hydrogel body is formed to cover fine stones or stone fragments (hereinafter referred to as lithotriptics), and the lithotriptics covered by the elastic hydrogel body are also extracted by extracting the elastic hydrogel body, so that the problem that the fine stones cannot be taken cleanly in the current clinic is solved, and pain of patients and probability of secondary operation are reduced. The elastic hydrogel body formed by the broken stone extraction system can cover a plurality of broken stones, so that a plurality of even all broken stones can be taken out at one time through one instrument channel, the instrument does not need to be replaced, the operation time is shortened, and the pain of a patient is reduced.
Drawings
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the disclosure and together with the description, serve to explain the principles of the disclosure. It will be apparent to those of ordinary skill in the art that the drawings in the following description are merely examples of the disclosure and that other drawings may be derived from them without undue effort. In the drawings:
FIG. 1 is a schematic diagram of a lithotripsy extraction system according to one embodiment of the disclosure;
FIG. 2 is a schematic illustration of crushed stone extracted by a crushed stone extraction system that may be used with embodiments of the present disclosure;
FIG. 3 is a schematic view of a conduit in a lithotripsy extraction system according to one embodiment of the disclosure;
FIG. 4 is a schematic illustration of a first composition injected using a lithotripsy extraction system provided by embodiments of the present disclosure;
FIG. 5 is a schematic illustration of a second composition injected using the lithotripsy extraction system provided by embodiments of the present disclosure;
FIG. 6 is a schematic illustration of an elastomeric hydrogel body formed after reaction of a second composition with a first composition;
FIG. 7 is a schematic drawing of a pulling of an elastomeric hydrogel body using a lithotripsy extraction system provided by embodiments of the present disclosure;
fig. 8 is a schematic structural view of a crushed stone extraction system according to another embodiment of the disclosure.
Reference numerals in the specific embodiments are as follows: the crushed stone extraction system 100, the conveying device 110, the accommodating part 111, the first carrier 1111, the second carrier 1112, the conduit 112, the first injection cavity 1121, the second injection cavity 1122, the bell mouth 113, the first composition 121, the second composition 122, the elastic hydrogel body 123 and the crushed stone 200.
Detailed Description
In order to make the objects, technical solutions and advantages of the present invention more apparent, the present invention will be described in further detail below with reference to the accompanying drawings, and it is apparent that the described embodiments are only some embodiments of the present invention, not all embodiments. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.
Unless defined otherwise, 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 terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the disclosure.
It should also be noted that the terms "comprises," "comprising," or any other variation thereof, are intended to cover a non-exclusive inclusion, such that a product or apparatus that comprises a list of elements does not include only those elements but may include other elements not expressly listed or inherent to such product or apparatus. Without further limitation, an element defined by the phrase "comprising" does not exclude the presence of other like elements in a commodity or device comprising such element.
In the description of the embodiments of the present invention, the azimuth or positional relationship indicated by the technical terms "upper", "lower", "thickness", etc. are based on the azimuth or positional relationship shown in the drawings, and are merely for convenience of describing the embodiments of the present invention and simplifying the description, and do not indicate or imply that the apparatus or element referred to must have a specific azimuth, be configured and operated in a specific azimuth, and thus should not be construed as limiting the embodiments of the present invention.
In the description of the embodiments of the present invention, the term "and/or" is merely an association relationship describing an association object, and indicates that three relationships may exist, for example, a and/or B may indicate: a exists alone, A and B exist together, and B exists alone. In addition, the character "/" herein generally indicates that the front and rear associated objects are an "or" relationship.
In the description of the embodiment of the present invention, the symbol "to" means that data of two endpoints before and after "to" and all data between the two endpoints, for example, a to B, means all data of a or more and B or less.
Reference in the present disclosure to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the present disclosure. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of skill in the art will explicitly and implicitly appreciate that the embodiments described in this disclosure may be combined with other embodiments.
As the background technology is adopted, the existing surgical instruments can not completely collect the stones in the operation, especially some fine stones, and the related researches show that the residual rate of the stones with the sizes of <3mm, <2mm, <1mm and the residual rate of the stones with the sizes of < 16.1% and 86% are respectively 10-15%. Therefore, patients usually need to assist the self-discharge of residual stones by adding means such as drinking water, medicines, special body positions, external physical vibration and stone discharge after operation. However, in the process of self-calculus removal, conditions such as hematuria, pain, and increased calculus load often occur. For example, common in-vitro physical vibration calculus removal is an intervention means for assisting in removing residual calculus after a soft ureteroscope operation, and is to conduct the residual calculus to a kidney region by an in-vitro physical vibration method to generate certain vibration, so as to promote the displacement of the residual calculus in the kidney and promote the self-discharge of the residual calculus. However, in vitro physical vibration calculus removal increases the calculus removal rate and also causes complications such as hematuria, renal colic, dizziness caused by calculus removal machine, and the like.
In view of the foregoing, there is provided in one aspect of an embodiment of the present application a lithotripsy extraction system comprising a delivery device and a hydrogel, wherein the hydrogel comprises a first composition comprising at least one crosslinkable polymer and a second composition comprising at least one crosslinking agent configured to encapsulate the lithotripsy after delivery to a lithotripsy location via the delivery device, the crosslinking agent configured to react with the crosslinkable polymer to form an elastomeric hydrogel body encapsulating the lithotripsy after delivery to the lithotripsy location via the delivery device; wherein the crosslinkable polymer and the crosslinking agent are autoclaved prior to forming the hydrogel, the crosslinkable polymer having a viscosity of less than 100cp; the delivery device is configured to remove the crushed stone after the elastic hydrogel body is adsorbed.
It can be seen that the lithotriptic extraction system provided by the embodiment of the application can also extract the lithotriptic particles coated by the elastic hydrogel body by forming the elastic hydrogel body coated with the fine lithotriptic particles or the lithotriptic fragments (hereinafter referred to as lithotriptic particles) and extracting the elastic hydrogel body, so that the problem that the fine lithotriptic particles cannot be taken cleanly in the current clinic is solved, and the pain of patients and the probability of secondary operation are reduced. The elastic hydrogel body formed by the broken stone extraction system can cover a plurality of broken stones, so that a plurality of even all broken stones can be taken out at one time through one instrument channel, the instrument does not need to be replaced, the operation time is shortened, and the pain of a patient is reduced.
Referring to fig. 1, an embodiment of the present application provides a lithotripsy extraction system 100 comprising a delivery device 110 and a hydrogel, wherein the hydrogel comprises a first composition 121 and a second composition 122, the first composition 121 comprising at least one crosslinkable polymer, the second composition 122 comprising at least one crosslinking agent, the crosslinkable polymer being configured to encapsulate a lithotripsy 200 after delivery to the location of the lithotripsy 200 via the delivery device 110, the crosslinking agent being configured to crosslink with the crosslinkable polymer after delivery to the location of the lithotripsy 200 via the delivery device 110 to form a resilient hydrogel body 123 encapsulating the lithotripsy 200; the delivery device 110 is configured to remove the crushed stone 200 after the elastic hydrogel body 123 is adsorbed.
The crushed stone 200 may be a fine stone or a fragment formed by crushing a larger stone, referring to fig. 2, when the stone is crushed, for example, by laser, the larger stone fragment may be removed by a conventional technique, and the remaining smaller stone fragment, for example, a stone fragment with a size of less than 3mm, may not be removed by a conventional apparatus or manner, and the smaller stone fragment may be removed by using the crushed stone extraction system 100 provided in the embodiment of the present application.
In some embodiments, the delivery device 110 includes a receiving portion 111 and a conduit 112, the conduit 112 is in communication with the receiving portion 111, and the first composition 121 and the second composition 122 can be delivered to the location of the crushed stone 200 via the conduit 112 after being placed in the receiving portion 111.
In some embodiments, referring to fig. 3, the end of the conduit 112 is further formed with a flare 113. As an example, the head of the flare 113 may be formed by heat-treating the distal end of the tube 112 to form a flare, and the flare 113 formed at the end of the tube 112 may more conveniently absorb the elastic hydrogel body, as shown in fig. 3 (a). The flare 113 may be formed of a memory material or a flexible material, and the flare 113 may be formed of a memory material or a flexible material to facilitate passage through the endoscope lumen as shown in fig. 3 (b).
The hydrogel includes a first composition 121 and a second composition 122. The first composition 121 comprises at least one crosslinkable polymer and the second composition 122 comprises at least one crosslinking agent.
Referring to fig. 4, the first composition 121 is configured to encapsulate the crushed stone 200 after being delivered to the position of the crushed stone 200 via the delivery device 110. In some embodiments, the delivery device 110 is used in conjunction with an endoscopic system by endoscopically injecting the first composition 121 through the delivery device 110 such that the first composition 121 reaches the lithotripsy 200 and flows around the lithotripsy 200.
The first composition 121 may be a multi-component composition comprising one or more crosslinkable polymers. In some embodiments, the first composition 121 is a two-component composition comprising at least one crosslinkable polymer. In some embodiments, the crosslinkable polymer is a cationic crosslinkable polymer. In some embodiments, the crosslinkable polymer comprises sodium alginate and the crosslinking agent comprises calcium chloride. The sodium alginate has a molecular weight of at least 40% ranging from 110000 to 500000, and as an alternative example, the sodium alginate has a 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% ranging from at least 110000, at least 150000, at least 200000, at least 250000, at least 300000, at least 350000, at least 400000, at least 450000, or at least 500000.
In some embodiments, the sodium alginate is a polysaccharide consisting of ancient Lu Tangsuan (Guluronic acid) and mannonic acid (Mannuronic acid). The ratio of Gu Lu acids and the ratio of mannonic acids may vary within a range in the alginate molecule, wherein the ratio of gulonic acids determines the ratio of mannonic acids, for example if the ratio of Gu Lu acids is 75% and the ratio of mannonic acids is 25%. The amount of Gu Lu gluconic acid in the sodium alginate may range from 30% to 95%, as an alternative example, the amount of guluronic acid may 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%.
In some embodiments, the crosslinkable polymer and the crosslinking agent are sterilized prior to forming the hydrogel, and the sterilization method is autoclaving.
If ethylene oxide is used for sterilization, the crosslinkable polymer and the crosslinking agent are dissolved in water, so that toxic gas is generated to endanger human health; if irradiation sterilization is used for the crosslinkable polymer and the crosslinking agent, the strength of the hydrogel is excessively reduced by irradiation sterilization, and the use requirement cannot be met. Thus, autoclaving was chosen as the product sterilization process.
In the high-pressure steam sterilization process, the concentration of the solution, the steam sterilization temperature, the steam sterilization time and the like have obvious and direct influence on the final effect of the product. Table 1 shows the effect of autoclaving temperature and steam sterilization time on the viscosity of sodium alginate solution, taking sodium alginate solution as an example.
TABLE 1
| Sodium alginate solution | Sterilization temperature/sterilization time | Viscosity before sterilization | Viscosity after sterilization |
| 1.5% (High M700-900 cp) | 121℃/26min | 3586cp | 72cp |
| 1.5% (High M700-900 cp) | 121℃/25min | 3586cp | 89cp |
| 1.0% (High M700-900 cp) | 121℃/15min | 888cp | 84cp |
| 0.5% (High M700-900 cp) | 121℃/10min | 170cp | 22cp |
| 0.5% (High M700-900 cp) | 121℃/10min | 175cp | 23cp |
| 0.6% (High M700-900 cp) | 121℃/10min | 252cp | 33cp |
| 0.6% (High M700-900 cp) | 121℃/10min | 250cp | 33cp |
| 0.7% (High M700-900 cp) | 121℃/10min | 399cp | 47cp |
| 0.7% (High M700-900 cp) | 121℃/10min | 387cp | 45cp |
| 0.8% (High M700-900 cp) | 121℃/10min | 552cp | 56cp |
| 0.8% (High M700-900 cp) | 121℃/10min | 560cp | 56cp |
| 0.9% (High M700-900 cp) | 121℃/10min | 842cp | 76cp |
| 0.9% (High M700-900 cp) | 121℃/10min | 840cp | 72cp |
| 0.5% (High M700-900 cp) | 121℃/5min | 170cp | 35cp |
| 0.5% (High M700-900 cp) | 121℃/5min | 175cp | 34cp |
| 0.6% (High M700-900 cp) | 121℃/5min | 252cp | 49cp |
| 0.6% (High M700-900 cp) | 121℃/5min | 250cp | 47cp |
| 0.7% (High M700-900 cp) | 121℃/5min | 399cp | 64cp |
| 0.7% (High M700-900 cp) | 121℃/5min | 387cp | 66cp |
| 0.8% (High M700-900 cp) | 121℃/5min | 552cp | 88cp |
| 0.8% (High M700-900 cp) | 121℃/5min | 560cp | 89cp |
| 0.9% (High M700-900 cp) | 121℃/5min | 842cp | 157cp |
| 0.9% (High M700-900 cp) | 121℃/5min | 840cp | 161cp |
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 autoclaving.
In some embodiments, the viscosity of the sterilized crosslinkable polymer is less than 100cp, and in particular, the viscosity of the sterilized crosslinkable polymer ranges from 75±10cp.
In some embodiments, the high pressure steam sterilization is performed for a period of time ranging from 5 to 30 minutes at a sterilization temperature greater than 120 ℃. In some embodiments, the crosslinkable polymer is a sodium alginate solution having a concentration of 0.5% to 1.5%.
Referring to fig. 5, the second composition 122 is configured to react with the crosslinkable polymer to form an elastomeric hydrogel body 123 surrounding the crushed stone 200 after delivery to the location of the crushed stone 200 via the delivery device 110. In some embodiments, the delivery device 110 is used in conjunction with an endoscopic system to endoscopically inject the second composition 122 through the delivery device 110.
Referring to fig. 6, the second composition 122 may be cross-linked with the first composition 121 to form a continuous elastic hydrogel body 123 surrounding the crushed stone 200, and the elastic hydrogel body 123 may encapsulate all the remaining crushed stone 200, and then the elastic hydrogel body 123 surrounding the crushed stone 200 may be removed from the body through the delivery device 110. The second composition 122 is capable of rapid solidification with the first composition 121 to form a continuous elastomeric hydrogel body 123, such as rapid solidification in the ureter, kidney.
Referring to fig. 7, the elastic hydrogel body 123 is taken out specifically as follows: after the hydrogel is injected, the hydrogel wraps the crushed stone 200 to form the hydrogel body 123, the bell mouth 113 of the delivery device 110 is tightly attached to the elastic hydrogel body 123, a negative pressure suction force is applied to the delivery device 110, the inside of the conduit 112 of the delivery device 110 is in a negative pressure state, the bell mouth 113 can absorb the elastic hydrogel body 123 wrapping the crushed stone 200, and the conduit 112 is removed and the elastic hydrogel body 123 is also taken out.
The second composition 122 may be a multi-component composition comprising one or more cross-linking agents capable of reacting with the cross-linkable polymer to form an elastomeric hydrogel body 123 surrounding the crushed stone 200. In some embodiments, the second composition 122 may be an aqueous barium chloride solution, an aqueous strontium chloride solution, or an aqueous calcium chloride solution.
In some embodiments, the crosslinkable polymer in the first composition 121 comprises a sodium alginate solution and the crosslinking agent in the second composition 122 comprises calcium chloride, wherein the concentration of calcium chloride may be 2.0% -10%.
The components and concentrations of the second composition 122 may be determined based on the first composition 121. For example, the effect of the final gel can be tested by varying concentrations of calcium chloride solution after determining the viscosity of the sodium alginate solution (75.+ -.10 cp). Table 2 shows the corresponding pullout effect of calcium chloride solutions of different concentrations when the final viscosity of the sodium alginate solution was 72cp, wherein calcium chloride of 2.0%, 4.0%, 6.0%, 8.0%, 10.0% concentration was selected to verify the hydrogel effect, on the basis that the entire gel could be pulled out the second time. The test environment is 39 ℃ constant temperature water bath kettle, 60ml physiological saline, and the in vitro test is performed.
TABLE 2
As can be seen from Table 2, the gripping efficiency of the calcium chloride solution with the concentration of 6.0% is best, and the calcium chloride solution can be completely taken out of the body after being taken out for 4 times on average; when the concentration of the calcium chloride solution is too low, the crosslinking reaction cannot be satisfied, so that the gel is too soft, the basket is easy to grasp and is not completely grasped; when the concentration of the calcium chloride solution is too high, gel is too hard, and the grabbing efficiency is not improved.
Table 3 shows multiple grasping experiments of calcium chloride solution with concentration of 6.0% when the final viscosity of sodium alginate solution is 72cp, the experimental environment is 39 ℃ constant temperature water bath, 60ml physiological saline, and in vitro experiments are performed in pig large intestine tissues.
TABLE 3 Table 3
As can be seen from Table 3, the simulated tissue test product, in pig large intestine tissue, the gel encapsulating the stones can be successfully removed from the body by 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. Wherein 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 distinguish the first composition 121 from the second composition 122 in operation. For example, the first composition 121 may comprise a bright blue dye and the second composition 122 may comprise a lemon yellow dye.
Referring to fig. 1 and 8 together, in some embodiments, the accommodating portion 111 further includes a first carrier 1111 and a second carrier 1112. Wherein, the first carrier 1111 is used for containing the first composition 121, the first carrier 1111 is detachably connected to the conduit 112, and the contained first composition 121 is further conveyed to the position of the crushed stone 200 through the conduit 112; the second carrier 1112 is configured to hold the second composition 122, and the second carrier 1112 is detachably connected to the conduit 112, so as to convey the second composition 122 to the location of the crushed stone 200 via the conduit 112. In the embodiment shown in fig. 1, the first carrier 1111 and the second carrier 1112 are in a split structure, and the first composition 121 and the second composition 122 may be sequentially delivered to the position of the crushed stone 200 respectively; the embodiment shown in fig. 8 is that the first carrier 1111 and the second carrier 1112 are of a one-piece structure, and the first composition 121 and the second composition 122 can be simultaneously delivered to the location of the crushed stone 200.
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 plunger rod matched with the syringe, wherein the liquid or gas is sucked from the small hole at the front end of the syringe when the plunger rod is pulled out, and the liquid or gas is extruded from the small hole at the front end of the syringe when the plunger rod is pushed in. The first and second carriers 1111, 1112 may be used to extract the corresponding first and second compositions 121, 122 and to inject the first and second compositions 121, 122 into the conduit 112.
In some embodiments, referring to fig. 8, the accommodating portion 111 further includes a first carrier 1111, a second carrier 1112, a synchronization fixing plate 1113, and a synchronization boosting plate 1114. Wherein, the first carrier 1111 is used for containing the first composition 121, the first carrier 1111 is detachably connected to the conduit 112, and the contained first composition 121 is further conveyed to the position of the crushed stone 200 through the conduit 112; a second carrier 1112 for containing the second composition 122, the second carrier 1112 being detachably connected to the conduit 112 for delivering the contained second composition 122 to the location of the crushed stone 200 via the conduit 112; the synchronization fixing plate 1113 is sleeved outside the first carrier 1111 and the second carrier 1112, the synchronization fixing plate 1113 is connected with the first carrier 1111 and the second carrier 1112 at the same time, specifically, the synchronization fixing plate 1113 is connected with the syringes of the first carrier 1111 and the second carrier 1112 respectively, and fixes 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 with each other to form a whole, and no relative displacement occurs; the synchronous boosting plate 1114 is respectively connected with the piston rods of the first carrier 1111 and the second carrier 1112, and the synchronous boosting plate 1114 may be disposed at tail portions of the piston rods of the first carrier 1111 and the second carrier 1112, so that the piston rods of the first carrier 1111 and the second carrier 1112 are connected to form a whole, and no relative displacement occurs. In operation of the conveying device 110, a pushing force is applied to the synchronous boost plate 1114, so that the synchronous boost plate 1114 moves relative to the synchronous fixing plate 1113, and the synchronous boost plate 1114 drives the piston rods of the first carrier 1111 and the second carrier 1112, so that the piston rods of the first carrier 1111 and the second carrier 1112 are pushed into the needle cylinders of the first carrier 1111 and the second carrier 1112. In the above process, the first composition 121 contained in the first carrier 1111 and the second composition 122 contained in the second carrier 1112 can be simultaneously injected to the target site to form the elastic hydrogel body 123.
In some embodiments, the catheter 112 is formed of a flexible material, such that the catheter 112 may flex to some extent as desired, and is strong, not prone to bending and breaking, and may be smoothly advanced into the endoscopic instrument channel. The hardness of the flexible material may range from 68D to 76D, for example 72D.
In some embodiments, the material of the catheter 112 may be a polyether block polyamide (pebax) material, and the pebax material has the characteristics of good toughness, difficult bending, toughened inner wall, and the like, and is less prone to deformation under the premise of good toughness compared with a PTFE material catheter, and is less prone to bending compared with a PE material catheter.
In some embodiments, the catheter 112 further comprises a first injection channel 1121 and a second injection channel 1122, wherein the first injection channel 1121 communicates with the first carrier 1111 and the second injection channel 1122 communicates with the second carrier 1112, such that the first composition 121 and the second composition 122 both have corresponding injection channels, preventing the first composition 121 and the second composition 122 from being mixed in advance in the channels.
In some embodiments, the lithotripsy extraction system 100 may be used with an electronic endoscope, the catheter 112 may be selected with consideration of parameters of an instrument channel of the electronic endoscope, and in particular, the catheter 112 may have an outer diameter smaller than the instrument channel of the electronic endoscope, for example, if the instrument channel of the electronic endoscope is 1.2mm, the catheter 112 may have an outer diameter smaller than 1.2mm, while considering the passage of the catheter 112 within the instrument channel, the inner diameter of the catheter 112 may be determined to be 1.00mm±0.05mm. And if the strength, toughness and liquid passing rate of the duct 112 are taken into consideration, the inner diameter of the duct 112 may be selected to be 0.60mm to 0.80mm. The working length of the catheter 112 may be 1300mm.
As an example, if the lithotriptic extraction system 100 provided in this embodiment is used to extract lithotriptic from a kidney, the normal renal pelvis volume is 5ml to 11ml according to the related literature, and if a self-locking syringe having a volume of 3ml is selected as the carrier for the hydrogel, the first composition 121 and the second composition 122 are each measured 3ml. When a syringe is used for injection by using a catheter 112 having an outer diameter of 1.00mm and an inner diameter of 0.80mm, the injection pressure of a 3ml syringe is about 7N, and manual injection can be selected for injection.
Further, the embodiment of the application also discloses a method for extracting crushed stone by using the crushed stone extraction system 100.
The lithotripsy extraction system 100 comprises a delivery device 110 and a hydrogel, wherein the hydrogel comprises a first composition 121 and a second composition 122, the first composition 121 comprising at least one cross-linkable polymer and the second composition 122 comprising at least one cross-linking agent, the cross-linkable polymer configured to encapsulate the lithotripsy 200 after delivery to the lithotripsy 200 site via the delivery device 110, the cross-linking agent configured to react with the cross-linkable polymer to form an elastomeric hydrogel body 123 encapsulating the lithotripsy 200 after delivery to the lithotripsy 200 site via the delivery device 110; the delivery device 110 is configured to remove the crushed stone 200 after the elastic hydrogel body 123 is adsorbed.
The conveying device 110 comprises a containing part 111 and a conduit 112, the conduit 112 is communicated with the containing part 111, and after the first composition 121 and the second composition 122 are placed in the containing part 111, the first composition and the second composition can be conveyed to the position of the crushed stone 200 through the conduit 112.
The accommodating portion 111 further includes a first carrier 1111 and a second carrier 1112. Wherein, the first carrier 1111 is used for containing the first composition 121, the first carrier 1111 is detachably connected to the conduit 112, and the contained first composition 121 is further conveyed to the position of the crushed stone 200 through the conduit 112; the second carrier 1112 is configured to hold the second composition 122, and the second carrier 1112 is detachably connected to the conduit 112, so as to convey the second composition 122 to the location of the crushed stone 200 via the conduit 112.
The method of extracting crushed stone using the crushed stone extraction system 100 includes:
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 the first carrier 1112;
S20, injecting a predetermined volume of the first composition 121 solution into a target area containing the crushed stone 200 to be extracted by using the first vehicle 1111;
S30, injecting a predetermined volume of the second composition 121 solution into a target area containing the crushed stone 200 to be extracted by using the second carrier 1112, and waiting for a predetermined time to enable the second composition 121 to undergo a crosslinking reaction with the first composition 121;
S40, the free end of the conduit 112 is close to the elastic hydrogel body 123, a negative pressure suction force is applied to the conveying device 110, the conduit 112 is in a negative pressure state, the conduit 112 is removed outwards, and the elastic hydrogel body 123 is removed together with the conduit 112.
In some embodiments, the preset time is greater than or equal to 5 seconds.
In some embodiments, the applying negative suction to the delivery device 110 comprises: a syringe with self-locking function is emptied of air from the syringe, connected to the catheter 112, and the plunger of the syringe is pulled to lock to a preset nominal scale. In some embodiments, the syringe is rated at 10ml.
In some embodiments, the catheter 112 is nested within the channel of the endoscopic instrument, and removal of the endoscope outward causes the catheter 112 to be removed along with the elastomeric hydrogel body 123 that is adsorbed by the free end of the catheter 112.
The application further researches the degradation condition of the hydrogel in vitro so as to verify the safety of the use environment. The verification method comprises the following steps: solid hydrogel was prepared and cut into 3mm pieces using a knife die for use. Placing the gel fragments into a container, covering and sealing the container with a test solution, maintaining a proper temperature, and simulating a physiological environment. During the different cycles of the test, the test solution was filtered using a 35 mesh 0.5mm stainless steel screen to see if gel remained on the screen. It is known that the time for placing the ureteral stent in a human body after a soft-lens lithotomy is 2-4 weeks, the minimum specification is 4.7F, the minimum inner diameter of the ureteral stent is 1.00+/-0.05 mm, and the holes at the two ends of the ureteral stent are 0.8mm in diameter, so that a stainless steel mesh screen with the diameter of 0.5mm with the size of 35 meshes is selected, and gel is not remained on the mesh screen after a test solution is screened, so that the gel can be proved to not block the ureteral stent.
The application further researches the hydrolysis/dissolution performance of the related materials. The specific process is as follows:
1.1 ml of sodium alginate solution is taken in the center of a glass dish by using a 3ml syringe, then 3ml of calcium chloride solution is taken by using a 5ml syringe, the solution is injected around the sodium alginate solution, the solution is waited for 5 minutes at room temperature, after the sodium alginate and the calcium chloride are crosslinked to generate gel, the gel is taken out by using tweezers, and the gel is placed in a new glass dish.
2. Gel fragments with the size of 3mm are accurately cut by using a 3mm cutting die, the cut gel fragments are transferred into reagent bottles by using tweezers, and every 6 gels are placed in one reagent bottle for 5 bottles in total. Set as group a, B, C, D total 4 groups were prepared in the same manner. 10ml of artificial urine having pH of 8.0 was added to each of the group A samples, 10ml of artificial urine having pH of 6.5 was added to each of the group B samples, 10ml of artificial urine having pH of 5.0 was added to each of the group C samples, and 10ml of physiological saline (pH=6.9.+ -. 0.3) was added to each of the group D samples.
Each set of samples was stored in an incubator at 37 ℃ and removed at a fixed time point, screened for gel dissolution, and after filtration, the new test solution was replaced until complete dissolution of the gel and data recorded.
Experimental data evaluation of the above procedure: and comparing the data before and after degradation with the results, and evaluating the degradation trend of the calcium alginate. 5 sets of samples (6 pieces of 3mm gel fragments each) were immersed in 10ml of physiological saline (ph=6.9±0.3) and artificial urine at different PH values, and the degree of dissolution of the samples was examined at a fixed time point to see whether gel fragments remained on the stainless steel mesh screen. Experimental data are shown in table 4 below.
TABLE 4 Table 4
The calcium alginate is pH sensitive hydrogel, has high requirement on pH value, is relatively stable in acid medium, is not suitable for swelling and dissolution, is soluble in alkaline medium, and can be seen from experimental data in table 4, 1) the calcium alginate is dissolved at the highest rate in artificial urine with pH of 8, gel fragments with the size of about 3mm are obtained, 4 groups of samples are dissolved after 1h, and 1 group of samples are dissolved after 2 h. Sample residual gel which is not dissolved for 1h is shown in figure 1; 2) The calcium alginate is dissolved in the artificial urine with the pH of 6.5 after 3mm and gel fragments after 2 hours; 3) In the artificial urine with the pH of 5.0, 3mm fragments gel 2 groups of samples are dissolved after 2 hours, and 3 groups of test samples are dissolved after 3 hours; 4) The dissolution rate of calcium alginate was the slowest in physiological saline with pH of about 6.9, and the gel fragments of about 3mm were dissolved after 3 hours for all 5 groups of samples.
According to the experiment, the calcium alginate hydrogel formed by complexing sodium alginate and calcium chloride through ion exchange reaction belongs to pH sensitive hydrogel, is stable in an acidic environment and is low in dissolution rate. Is soluble under alkaline conditions, has a faster dissolution rate, is most stable in neutral environments, but can be degraded at a slow rate. Gel fragments with the size of about 3mm can be dissolved in urine and physiological saline for about 3 hours. The degradation of the alginate hydrogel is carried out by hydrolysis or enzymolysis. Under the action of water molecules, the network structure of the alginate hydrogel is gradually loosened, so that the physical property of the hydrogel is changed, and the alginate hydrogel is finally decomposed into monomers or small molecules. Therefore, the product can be found that if residues exist during stone extraction, the human body can be dissolved by itself, and no excessive harm is caused to the human body.
The present application further provides the following examples and comparative examples.
Example 1
(1) Preparing sodium alginate A aqueous solution with the concentration of 1.5% and the concentration of 0.001% of brilliant blue powder, wherein the PH value of the sodium alginate A aqueous solution is about 7.8; preparing anhydrous calcium chloride into a calcium chloride B aqueous solution with the concentration of 6.0% and the concentration of lemon yellow powder of 0.003%, wherein the pH value of the calcium chloride B aqueous solution is about 4.6; the final viscosity of the sodium alginate solution after wet heat sterilization is 72cp;
(2) Preparing a pebax catheter with a length of 1300mm and a delivery system catheter of 1.0 x 0.8 mm;
(3) The simulated kidney is continuously injected with physiological saline at the flow rate of 2.0 mL/min;
(4) Injecting 0.5ml of a solution through a delivery system into the simulated kidney region containing the kidney stone fragments to be removed using a 10ml syringe;
(5) Injecting 1.5mlB solution into the vicinity of the region in step (3) through a delivery system using a 10ml syringe to cause a crosslinking reaction;
(6) Preparing a three-jaw basket grab to grab gel through a urinary sheath;
(7) The ureteroscope was removed outward along with the gel surrounding the stone fragments.
Example 2
(1) Preparing sodium alginate A aqueous solution with the concentration of 1.0% and the concentration of 0.001% of brilliant blue powder, wherein the PH value of the sodium alginate A aqueous solution is about 7.8; preparing anhydrous calcium chloride into a calcium chloride B aqueous solution with the concentration of 6.0% and the concentration of lemon yellow powder of 0.003%, wherein the pH value of the calcium chloride B aqueous solution is about 4.6; the final viscosity of the sodium alginate solution after wet heat sterilization is 72cp;
(2) Preparing a pebax catheter with a length of 1300mm and a delivery system catheter of 1.0 x 0.8 mm;
(3) The simulated kidney is continuously injected with physiological saline at the flow rate of 2.0 mL/min;
(4) Injecting 0.5ml of a solution through a delivery system into the simulated kidney region containing the kidney stone fragments to be removed using a 10ml syringe;
(5) Injecting 1.5mlB solution into the vicinity of the region in step (3) through a delivery system using a 10ml syringe to cause a crosslinking reaction;
(6) Preparing a three-jaw basket grab to grab gel through a urinary sheath;
(7) The ureteroscope was removed outward along with the gel surrounding the stone fragments.
Comparative example 1
(1) Preparing sodium alginate A aqueous solution with the concentration of 1.5% and the concentration of 0.001% of brilliant blue powder, wherein the PH value of the sodium alginate A aqueous solution is about 7.8; preparing anhydrous calcium chloride into a calcium chloride B aqueous solution with the concentration of 6.0% and the concentration of lemon yellow powder of 0.003%, wherein the pH value of the calcium chloride B aqueous solution is about 4.6; the final viscosity of the sodium alginate solution after wet heat sterilization is 200cp;
(2) Preparing a pebax catheter with a length of 1300mm and a delivery system catheter of 1.0 x 0.8 mm;
(3) The simulated kidney is continuously injected with physiological saline at the flow rate of 2.0 mL/min;
(4) A 10ml syringe was used to inject 1.0ml of a solution through the delivery system into the simulated kidney region containing the kidney stone fragments to be removed.
In this comparative example, step (4) manually pushed the syringe and the injection force was too great to achieve injection and the experiment was aborted.
Comparative example 2
(1) Preparing sodium alginate A aqueous solution with the concentration of 1.5% and the concentration of 0.001% of brilliant blue powder, wherein the PH value of the sodium alginate A aqueous solution is about 7.8; preparing anhydrous calcium chloride into a calcium chloride B aqueous solution with the concentration of 2.0% and the concentration of lemon yellow powder of 0.003%, wherein the pH value of the calcium chloride B aqueous solution is about 6.7; the final viscosity of the sodium alginate solution after wet heat sterilization is 72cp;
(2) Preparing a pebax catheter with a length of 1300mm and a delivery system catheter of 1.0 x 0.8 mm;
(3) The simulated kidney is continuously injected with physiological saline at the flow rate of 2.0 mL/min;
(4) Injecting 0.5ml of a solution through a delivery system into the simulated kidney region containing the kidney stone fragments to be removed using a 10ml syringe;
(5) Injecting 1.5mlB solution into the vicinity of the region in step (3) through a delivery system using a 10ml syringe to cause a crosslinking reaction;
(6) Preparing a three-jaw basket grab to grab gel through a urinary sheath;
In this comparative example, the formed gel had poor strength, and the use of basket to grasp was impossible, and the gel had poor coating properties on the stone, and the grasping process caused the stone to separate from the gel, and the stone could not be taken out of the body.
Compared with the prior art, the broken stone extraction system provided by the embodiment of the application can also extract broken stone coated by the elastic hydrogel body by forming the elastic hydrogel body coated with fine stones or stone fragments (hereinafter called broken stone), so that the problem that the fine small stones cannot be taken in the current clinic is solved, and the pain of patients and the probability of secondary operation are reduced. The elastic hydrogel body formed by the broken stone extraction system can cover a plurality of broken stones, so that a plurality of even all broken stones can be taken out at one time through one instrument channel, the instrument does not need to be replaced, the operation time is shortened, and the pain of a patient is reduced.
Finally, it should be noted that: the above embodiments are only for illustrating the technical solution of the present disclosure, and not for limiting the same; although the present disclosure has been described in detail with reference to the foregoing embodiments, it should be understood by those of ordinary skill in the art that: the technical scheme described in the foregoing embodiments can be modified or some or all of the technical features thereof can be replaced by equivalents; such modifications and substitutions do not depart from the spirit of the embodiments of the disclosure, and are intended to be included within the scope of the claims and specification of the present disclosure. In particular, the technical features mentioned in the respective embodiments may be combined in any manner as long as there is no structural conflict. The present disclosure is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.
Claims (10)
1. A crushed stone extraction system is characterized by comprising a conveying device and hydrogel, wherein,
The hydrogel comprises a first composition comprising at least one crosslinkable polymer and a second composition comprising at least one crosslinking agent configured to encapsulate the crushed stone after delivery to a crushed stone location via the delivery device, the crosslinking agent configured to react with the crosslinkable polymer to form an elastomeric hydrogel body encapsulating the crushed stone after delivery to a crushed stone location via the delivery device; wherein the crosslinkable polymer and the crosslinking agent are autoclaved prior to forming the hydrogel, the crosslinkable polymer having a viscosity of less than 100cp;
the delivery device is configured to remove the crushed stone after the elastic hydrogel body is adsorbed.
2. The lithotriptic extraction system of claim 1, wherein the first composition further comprises at least one dye and/or the second composition further comprises at least one dye.
3. The lithotripsy extraction system according to claim 1, wherein the crosslinkable polymer is a cationic crosslinkable polymer.
4. The lithotripsy extraction system according to claim 1, wherein the crosslinkable polymer comprises sodium alginate and the crosslinking agent comprises calcium chloride.
5. The lithotriptic extraction system of claim 4, wherein the concentration of sodium alginate is between 0.5% and 1.5%, and wherein the high pressure steam sterilization is performed for a period of between 5 minutes and 30 minutes at a sterilization temperature greater than 120 ℃.
6. The lithotripsy extraction system according to claim 4, wherein the concentration of calcium chloride is 2.0% -10%.
7. The lithotriptic extraction system of claim 4, wherein the sodium alginate has a molecular weight of at least 40% ranging from 110000 to 500000; the sodium alginate is a polysaccharide consisting of ancient Lu Tangsuan and mannonic acid; the content of Gu Lutang acid in the sodium alginate is 30% -95%.
8. The lithotriptic extraction system of claim 7, wherein the delivery device comprises a receptacle and a conduit in communication with the receptacle, the first and second compositions being delivered to a lithotriptic location via the conduit after placement in the receptacle.
9. The lithotripsy extraction system of claim 8, wherein the conduit is formed of a flexible material having a hardness of 72D.
10. The lithotripsy extraction system according to claim 8, wherein an end of the conduit forms a flare formed of a memory material or a flexible material.
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