CN217510566U - Mucous membrane uplift surgical instrument system under endoscope - Google Patents

Abstract

The utility model relates to the field of medical consumables, in particular to an endoscopic mucosal swelling surgical instrument system, which comprises a swelling gel for endoscopic mucosal swelling, a prefilled syringe for subpackaging the swelling gel, an endoscopic injection needle for swelling gel injection and a pressurizing device; the pre-filled syringe filled with the raised gel is filled into a pressurizing device, and the head end of the pre-filled syringe is connected with the connecting end of a lower injection needle of the endoscope; the prefilled syringe is packed into the telescopic draw-in groove of pressure device, and syringe core pipe roof supports prefilled syringe core pipe, and rotatory push rod that promotes through the knob advances, pours into mucosa lower floor into protruding gel through injection needle under the scope, and this use is novel mucous membrane uplift surgical instruments system under scope that provides has the use of alimentary canal mucosa normal position injection under the scope.

Description

Mucous membrane uplift surgical instrument system under endoscope

Technical Field

The utility model relates to a medical treatment consumptive material field especially relates to a mucous membrane uplift surgical instruments system under scope for alimentary canal.

Background

The mucosa bulging of the digestive tract under the endoscope is one of the most critical steps in EMR (endoscopic mucosal dissection)/ESD (endoscopic mucosal dissection), and the good and effective mucosa bulging effect can effectively reduce complications such as bleeding and perforation.

The mucosal layer of the digestive tract occurs in the endoderm, while the intrinsic muscularis occurs in the mesoderm, with loose connective tissue in the middle to make up the submucosa. Injecting liquid below and around the focus can lift the focus and separate from the intrinsic muscle layer, ensure that the focus is completely cut off in one piece, and simultaneously reduce the occurrence of the complication of the operation as much as possible. In addition, according to whether the lifting symptom is positive or not, whether the focus infiltrates into the intrinsic muscular layer or not can be judged. According to the American society for digestive endoscopy (ASGEE) recommendations, the ideal submucosal fluid should include the following characteristics: (1) providing a thick submucosal liquid pad; (2) under the mucosa for a sufficient time to ensure successful completion of the ESD/EMR; (3) the completeness of the excision focus is ensured, so that correct pathological detection can be completed; (4) the price is cheap, the acquisition is easy, and the preservation is convenient; (5) no toxicity to tissues and no damage; (6) easy injection.

Clinically, physiological Saline (Normal Saline Solution) is the mucosal swelling fluid which is most widely used at present. Its safety and low price are well recognized. The normal saline solution added with indigo carmine and a small amount of adrenaline is commonly used by domestic hospitals; the epinephrine content of 0.0005% can cause local vasoconstriction to play a role in hemostasis, and the addition of the indigo carmine can enable doctors to distinguish the range of stripping more easily; injecting physiological saline solution added with indigo carmine and a small amount of epinephrine into submucosa with an endoscopic injection needle to make the lesion part rise, and performing ESD or EMR. During clinical use, doctors find that isotonic saline is easily absorbed by surrounding tissues, and the generated submucosal fluid cushion is difficult to maintain at a satisfactory height for a long time, and often needs to be injected repeatedly.

Although there have been many attempts in the prior art to replace saline, the developed materials have more or less various drawbacks. The invention patent CN105899241A provides an emulsion or microemulsion for use in endoscopic mucosal resection and/or endoscopic submucosal dissection. The patent discloses pharmaceutical compositions of emulsions or microemulsions comprising: (1) an aqueous phase; (2) an oil phase; (3) at least one surfactant; (4) at least one reverse thermosensitive polymer; (5) optionally at least one physiologically acceptable excipient; (6) optionally at least one co-surfactant; (7) at least one dye; (8) optionally at least one agent characterized by nutritional activity on gastrointestinal mucosal epithelial cells; (9) optionally at least one therapeutic agent. The invention patent CN105899241A also provides a kit for use in an endoscopic procedure, comprising a pharmaceutical composition in the form of an emulsion or microemulsion, an endoscopic injection needle, a syringe and instructions for use. The emulsion or the microemulsion has more components and relatively complex manufacturing process; and the common injector is adopted to inject the temperature-sensitive emulsion or microemulsion, so that the injection resistance is large, and the injection resistance disclosed in the embodiment is 65N and 76N, which is not beneficial to popularization and application of the product. The patent CN108498879A provides a submucosal injection preparation prepared from biocompatible modified starch, but the injection preparation has no coloring agent, the doctor can not clearly distinguish the range of stripping, and perforation, bleeding or delayed bleeding can be caused when ESD/EMR operation is carried out.

Utility model

In view of the above-mentioned shortcomings of the prior art, an object of the present invention is to provide an endoscopic surgical instrument system for treating mucosa swelling in the digestive tract, which is used to solve the problems in the prior art.

In order to realize the above-mentioned purpose and other relevant purpose, the utility model provides a mucous membrane uplift surgical instrument system under scope, including uplift gel (1) that is used for mucous membrane uplift under the scope for fill syringe (2) in advance of partial shipment uplift gel, injection needle (3) and pressure device (4) under the scope for uplift gel injection, its characterized in that is equipped with in filling syringe (2) in advance of uplift gel packs into pressure device (4), fill syringe head end in advance and injection needle link connection under the scope.

In some embodiments of the present invention, the raised gel is a temperature sensitive gel comprising a first polyoxyethylene and polyoxypropylene block copolymer component, a second polyoxyethylene and polyoxypropylene block copolymer component, an electrolyte, a coloring agent, and water for injection; the first polyoxyethylene and polyoxypropylene block copolymer is preferably poloxamer 407 and the second polyoxyethylene and polyoxypropylene block copolymer is preferably poloxamer 188. The electrolyte is selected from one or more of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate; the coloring agent is selected from one or more of methylene blue, indigo carmine and Lugol iodine; the components of the ridge gel were mixed well and dispensed into 10ml or 20ml pre-filled syringes. The prefilled syringe containing the raised gel may be sterilized by heat and humidity or by any other suitable method.

In some embodiments of the present invention, the prefilled syringe comprises a needle tubing, a rubber plug, and a core tube, and the outlet end of the needle tubing is a luer lock fitting.

In some embodiments of the present invention, the diameter of the needle head of the injection needle under the endoscope is 20gauge to 25 gauge, the outer diameter of the tube body is 1.8mm to 2.3mm, and the effective length of the tube body is 200cm to 250 cm.

In some embodiments of the present invention, the endoendoscopic injection needle is comprised of a material selected from the group consisting of, but not limited to: polymers or copolymers, such as Polyethylene (PE), Polytetrafluoroethylene (PTFE), Polyamide (PA), Polycarbonate (PC), and the like; metals and metal alloys such as stainless steel, nitinol, and the like.

In some embodiments of the present invention, the under-endoscope injection needle handle has a luer lock fitting that is connectable to the distal end of a prefilled syringe; the sub-endoscopic injection needle may be retracted.

In some embodiments of the present invention, the pressurizing device comprises a sleeve, a syringe core tube top plate, a push rod and a knob; the push rod is provided with threads, one end of the push rod is connected with the injector core tube top plate, and the other end of the push rod is connected with the knob; one end of the sleeve is provided with a fixed clamping groove for fixing the prefilled syringe; the inner side of the other end of the sleeve is provided with a threaded hole which is connected with the push rod; the pressurizing device rotates through a knob to drive the push rod and the injector core tube top plate to move back and forth; the pressurizing device is made of light aluminum alloy.

The utility model discloses in some embodiments, in the telescopic draw-in groove of pressure device was packed into to the prefilled syringe, syringe core pipe roof supported prefilled syringe core pipe, advanced through the rotatory push rod that promotes of knob, injected the uplift gel into the syringe needle.

The utility model provides an endoscope lower alimentary canal mucous membrane uplift surgical instrument system has endoscope lower alimentary canal mucous membrane in-situ injection purpose.

Drawings

FIG. 1 is a schematic view of the present invention;

FIG. 2 is a schematic view showing the structure of the injection needle under the endoscope of the present invention;

FIG. 3 is a schematic view of the structure of the pressurizing device of the present invention;

fig. 4 shows a schematic view of the assembly of the prefilled syringe and pressurizing device of the present invention;

fig. 5 shows a photograph of the stomach mucosa peeling operation of a aged white pig in example 2 of the present invention.

Description of the element reference numerals

1 bump gel

2 Pre-filled syringe

3 endoscopic injection needle

4 pressurizing device

5 handle

6 pipe body

7 needle

8 knob

9 push rod

10-core tube top plate

11 sleeve

11-1 card slot

12 syringe core tube

13 syringe needle tube

14 syringe luer lock fitting

15 Syringe cock

Detailed Description

Polyoxyethylene and polyoxypropylene block copolymers are a polymer network consisting of hydrophilic polymers that swell in water and retain structure while also absorbing water molecules. The present inventors have conducted a number of exploratory experiments to utilize two different polyoxyethylene and polyoxypropylene block copolymers as the gel host matrix and conditioner, respectively, to create a raised gel. Prepared into a swelling gel with simple manufacturing process, can meet the requirements of in-situ injection under EMR and ESD operation mucous membranes under an endoscope, has proper gel conversion temperature and good viscosity and injection pressure, and the utility model is completed on the basis.

The utility model provides a swelling gel, including first polyoxyethylene and polyoxypropylene block copolymer component (preferred poloxamer 407), second polyoxyethylene and polyoxypropylene block copolymer component (preferred poloxamer 188), electrolyte, coloring agent and water.

In the swelling gel provided by the utility model, poloxamer 407 is used as the main matrix in the hydrogel to meet the use requirements of the temperature-sensitive hydrogel in human body, and the concentration is preferably 15.5-17.5 wt%. Poloxamer 188 is used as a regulator in the hydrogel to regulate the different gel transition temperatures of the hydrogel, which is preferably 0.5-2.5 wt%. The electrolyte may be any electrolyte suitable for endoscopic in situ injection for adjusting the osmotic pressure of the raised gel, including but not limited to a combination of one or more of sodium chloride, sodium dihydrogen phosphate, disodium hydrogen phosphate, etc., preferably at a concentration of 0.5-0.9%. The staining agent may be any of various staining agents suitable for in situ endoscopic injection in the art for distinguishing the range of normal combinations and lesions, and may be a combination including, but not limited to, one or more of methylene blue, indigo carmine, lugol's iodine, etc., preferably at a concentration of 0.1-1.0%.

In the swelling gel provided by the utility model, the gel transition temperature of the swelling gel can be adjusted by adjusting the proportion of poloxamer 407 and/or poloxamer 188 components. The gel transition temperature generally refers to the temperature at which a gel transitions from a liquid state to a solid state or gel, the raised gel being a liquid at room temperature, and the gel gradually transitioning from a liquid state to a gel state under the influence of body temperature when injected into the body during an ESD or EMR procedure. The gel transition temperature of the ridge gel is usually not higher than the body temperature of a human body, and is preferably 33-36 ℃. The viscosity range of the raised gel solution at room temperature (25 ℃) is preferably < 50cp, and the viscosity range at body temperature (36.5 ℃) is preferably 1000-.

The utility model provides an injection needle under scope, the syringe needle diameter of specific 20gauge to 25guage, 1.8mm to 2.3 mm's external diameter, 200cm to 250 cm's effective length. Suitable endoscopic injection needles are constructed from materials selected from the group including, but not limited to: polymers or copolymers, such as Polyethylene (PE), Polytetrafluoroethylene (PTFE), Polyamide (PA), Polycarbonate (PC), and the like; metals and metal alloys such as stainless steel, nitinol, and the like. Suitable under-endoscope injection needles, in addition to the inventor's own under-endoscope injection needle, may be selected from the group of marketed under-endoscope injection needles including, without limitation, Cook, Boston Scientific, Endo-flex, and the like.

The pressurizing device provided by the utility model consists of a sleeve, an injector core tube top plate, a push rod and a knob; the sleeve is provided with a clamping groove for fixing a pre-filled syringe; the inner side of the sleeve is provided with threads for the front and back movement of the injector core tube top plate.

The utility model provides a pair of alimentary canal mucous membrane uplift surgical instrument system under scope uses in ESD or EMR operation through following step:

1) retracting the injection needle head of the injection needle under the endoscope, reaching the lesion part of the mucous membrane through the endoscope, and pushing the handle to insert the injection needle head into the submucosa of the mucous membrane of the alimentary tract;

2) loading the pre-filled syringe filled with the raised gel into a pressurizing device, loading the pre-filled syringe into a clamping groove of a sleeve of the pressurizing device, and pushing a top plate of a syringe core tube against the pre-filled syringe core tube;

3) and opening a cock of the syringe to be prefilled, and connecting a luer locking joint at the far end of the syringe with an endoscopic injection needle handle.

4) The knob of the pressurizing device is rotated to push the push rod to advance, the raised gel is injected into proper volume of liquid to the submucosa of the alimentary canal through the injection needle, and the injected liquid changes the gel cushion layer with certain thickness at a proper position.

The utility model provides a surgery instrument system for alimentary canal mucous membrane uplift under endoscope, uplift gel is injected into the alimentary canal mucous membrane lower layer to form a high 'water cushion' under the action of body temperature, and the coloring agent can be convenient for an operator to distinguish the mucous membrane lower layer and the muscular layer under the endoscope, thereby reducing the occurrence risk of perforation when the operator performs EMR or ESD surgery; at the same time, the "water cushion" created by the raised gel is sufficiently durable to satisfy an ESD or EMR surgical procedure without requiring multiple injections to complete the procedure as is the case with saline solutions.

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

It is to be understood that the processing equipment or apparatus not specifically identified in the following examples is conventional in the art.

Furthermore, it is to be understood that one or more method steps mentioned in the present application do not exclude that other method steps may also be present before or after the combined steps or that other method steps may also be inserted between these explicitly mentioned steps, unless otherwise indicated; it is also to be understood that references to a combined connection between one or more devices/apparatus in the present disclosure are not to preclude the presence or addition of further devices/apparatus before or after the combined device/apparatus, unless otherwise indicated. Moreover, unless otherwise indicated, the numbering of the various method steps is merely a convenient tool for identifying the various method steps, and is not intended to limit the order in which the method steps may be arranged or the scope of the invention which may be practiced.

Example 1

Preparation of a swelling gel poloxamer 407 and poloxamer 188 were dissolved in water for injection containing electrolytes and a coloring agent.

Components	The content is wt%
		Poloxamer 407	15.5％
Poloxamer 188	1％
		Sodium chloride	0.9％
Methylene blue	0.3％
		Water for injection	Balance of

The specific formulation procedure is as follows (final 1000g of raised gel)

1) 823g of water for injection was added to a suitable vessel equipped with a stirrer, 9g of sodium chloride was added, and the mixture was stirred until completely dissolved.

2) Adding 155g of poloxamer 407 and 10g of poloxamer 188, placing at 2-8 ℃, and continuing stirring until the poloxamer is completely dissolved.

3) 3g of methylene blue was added and stirred until completely dissolved to obtain a swollen gel stock solution.

4) The swollen gel stock solution is filled into a pre-filled syringe, and a rubber plug is added, wherein the filling amount of each bottle is 10 ml.

5) The prefilled syringe filled with the bulge gel can be sterilized by moist heat at 121 deg.C for 10 min.

6) And adding a core tube into the sterilized prefilled syringe for later use.

Example 2

The raised gel prepared according to example 1 (pre-filled syringe package) was subjected to endoscopic ESD experiments on the gastric mucosa of adult white pigs using a 20G syringe needle. The specific experimental process is as follows:

the injection needle head 7 of the injection needle under the endoscope retracts, reaches the lesion part of the mucous membrane through the endoscope, and pushes the handle 5 to insert the injection needle head 7 into the submucosal layer of the mucous membrane of the alimentary canal; loading the pre-filled syringe filled with the raised gel into a pressurizing device, loading the pre-filled syringe into a clamping groove 11-1 of a sleeve 11 of the pressurizing device, and pushing a syringe core tube top plate 10 against a pre-filled syringe core tube 12; opening a cock 15 of the syringe to be prefilled, and connecting a luer lock joint 14 at the far end of the syringe with an endoscopic injection needle handle 5; the knob 8 of the pressurizing device is rotated to push the push rod 9 to advance, the swelling gel is injected into proper volume of liquid to the lower layer of the alimentary canal mucous membrane through the injection needle, after in-situ injection is completed, the swelling gel gradually changes to a gel state under the influence of the body temperature of an animal, and the stomach mucous membrane at the in-situ injection point is obviously lifted to a proper height (figure 5-A). After incision of the gastric mucosa, the swelling gel solution was found to form a thicker "liquid pad" under the mucosa (fig. 5-B); during the whole 30-minute mucosa stripping operation (fig. 5-B, fig. 5-C and fig. 5-D), the 'liquid pad' formed by the raised gel is always maintained at a proper height, and the requirement of the mucosa stripping operation can be met without secondary injection. After completion of the mucosal dissection surgery, no perforation, bleeding or delayed bleeding occurred at the surgical site (fig. 5-E, fig. 5-F). Animal experiments show that the uplifted gel solution adopted by the utility model can meet the requirement of ESD operation in-situ injection without repeated injection for many times. Meanwhile, the pressurizing device is small and portable, and the push rod is pushed to move forwards and backwards through the rotation of the knob, so that the swelling gel can be easily injected into the submucosa of the alimentary tract.

To sum up, the utility model discloses effectively overcome all kinds of shortcomings among the prior art and had high industrial utilization value.

The above embodiments are merely illustrative of the principles and effects of the present invention, and are not to be construed as limiting the invention. Modifications and variations can be made to the above-described embodiments by those skilled in the art without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which may be made by those skilled in the art without departing from the spirit and technical spirit of the present invention shall be covered by the claims of the present invention.

Claims (7)

1. The utility model provides a mucous membrane uplift surgical instruments system under scope, is including the uplift gel that is used for mucous membrane uplift under the scope for the prefilled syringe of partial shipment uplift gel, injection needle and pressure device under the scope for uplift gel injection, its characterized in that, the prefilled syringe that is equipped with uplift gel packs into in the pressure device, prefilled syringe head end is connected with injection needle connection end under the scope.

2. The endoscopic mucosal ridge surgical device system of claim 1, wherein the ridge gel is a temperature sensitive gel.

3. The endoscopic mucosal ridge surgical device system of claim 1, wherein the pre-filled syringe is comprised of a syringe barrel, a syringe cock and a syringe barrel, the outlet end of the barrel being a syringe luer lock fitting.

4. The endoscopic mucosal ridge surgical device system according to claim 1, wherein the endoscopic injection needle has a needle diameter of 20gauge to 25 gauge, a tube body outer diameter of 1.8mm to 2.3mm, and a tube body effective length of 200cm to 250 cm.

5. The endoscopic mucosal bulging surgical device system according to claim 1, wherein the endoscopic injection needle proximal handle has a luer lock connector connectable to a distal end of a prefilled syringe; the sub-endoscopic injection needle may be retracted.

6. The endoscopic mucosal ridge surgical device system according to claim 1, wherein the pressurizing means is comprised of a sleeve, a core tube top plate, a push rod and a knob; the push rod is provided with threads, one end of the push rod is connected with the core tube top plate, and the other end of the push rod is connected with the knob; one end of the sleeve is provided with a fixed clamping groove for fixing the pre-filled syringe; the inner side of the other end of the sleeve is provided with a threaded hole and is connected with the push rod; the pressurizing device rotates through the knob to drive the push rod and the core tube top plate to move back and forth; the pressurizing device is made of light aluminum alloy.

7. The endoscopic mucosal bulging surgical instrument system according to claim 6, wherein the prefilled syringe is loaded into a neck of a sleeve of the pressurizing device, a top plate of the core tube abuts against a core tube of the prefilled syringe, and the push rod is advanced by rotation of the knob to inject the bulging gel into the injection needle.

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