Intestinal flora transplantation administration device and administration method

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to an intestinal flora transplantation administration device and an administration method. The dosing device comprises a protective casing pipe (1) and a dosing pipe (2) sleeved in the protective casing pipe (1); the sheath tube (1) is connected with the colonoscope and enters the intestinal tract through the colonoscope; the side part of the tail end of the dosing tube (2) is provided with a dosing hole (21), the outer side of the dosing tube (2) is detachably connected with a fixing piece (3), the inner side of the dosing tube (2) is detachably provided with a connecting piece (4), and the dosing tube (2) is connected with the fixing piece (3) through the connecting piece (4); the drug delivery method is a method using the drug delivery device. Compared with the prior art, the device has the advantages that the administration tube can be quickly fixed and detached, the intestinal tract is prevented from being damaged, and meanwhile, long-term and accurate administration can be carried out on the interior of the intestinal tract.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to an intestinal flora transplantation drug delivery device and a drug delivery method. Background Art

[0002] Intestinal microbiota transplantation (FMT), also known as fecal microbiota transplantation or microbiota transplantation, is a procedure that involves transplanting functional microbiota from healthy human feces into the patient's intestines. This helps the patient rebuild a new intestinal microbiota, regulate intestinal microbiota imbalance, restore intestinal microbiota diversity, and achieve the treatment of intestinal and extraintestinal diseases. In 2013, intestinal microbiota transplantation was officially included in clinical guidelines by the US FDA and was selected as one of the "Top Ten Medical Breakthroughs" by Time magazine that year. Currently, common transplantation methods include oral capsules, enemas, endoscopic infusion, and colonoscopic infusion. Oral capsules are convenient for patients to take, but the bacteria are easily released in the stomach or proximal small intestine, making it difficult to accurately cover the colonic lesions. Enemas allow the bacteria to reach the intestine directly, but the infusion depth is shallow, and long-term enema use may damage the rectal mucosa. Endoscopic or colonoscopic infusion can precisely deliver the bacteria to specific areas, but endoscopy cannot be used long-term, and repeated procedures increase patient pain and medical costs, making continuous drug delivery difficult.

[0003] Patent CN 110710952 A discloses a transanal deep-implant device for the ileocecal valve and its implantation method. The device comprises a drug delivery tube and a fixed wire fixedly connected to the distal wall of the tube. The drug delivery tube is a flexible, polymeric material tube with two open ends. One or more drug delivery holes communicating with the interior of the tube are provided on the distal end or on the side wall of the tube. A guide wire is inserted into the tube, allowing it to move freely back and forth within the tube. The cross-section of the guide wire is smaller than the inner diameter of the tube. An extension piece is movably connected to the proximal end of the tube. This patent administers medication through a tube, but the tube is positioned and removed using an internal guide wire, making removal difficult. Incomplete removal of the guide wire may result in intestinal damage.

[0004] Existing transplantation methods have problems in terms of intestinal protection, positioning accuracy and long-term indwelling safety. There is an urgent need to develop a dedicated drug delivery device that is minimally invasive, can be indwelled, precisely anchored and adapted to the characteristics of bacterial flora infusion. Summary of the Invention

[0005] (1) Technical issues to be resolved The purpose of the present invention is to provide an intestinal flora transplantation drug delivery device and a drug delivery method in order to solve at least one of the above problems, so as to solve the problem in the prior art that the drug delivery tube is difficult to fix during intestinal flora transplantation, or the intestinal tract is damaged when the drug delivery tube is removed after fixation, so as to achieve the effect of quickly fixing and removing the drug delivery tube, avoiding damage to the intestine, and at the same time being able to achieve the effect of long-term and accurate drug delivery to the inside of the intestine.

[0006] (2) Technical solution The purpose of the present invention is achieved through the following technical solutions: The first aspect of the present invention discloses an intestinal flora transplantation drug delivery device, comprising a sheath tube and a drug delivery tube sleeved inside the sheath tube; The sheath tube is connected to the colonoscope and enters the intestine through the colonoscope; A dosing hole is provided on the side of the end of the dosing tube. A fixing piece is detachably connected to the outside of the dosing tube. A connecting piece is detachably provided on the inside of the dosing tube. The dosing tube is connected to the fixing piece via the connecting piece.

[0007] The sheath tube enters the rectum and colon and reaches the ileocecal part as the colonoscope is operated.

[0008] Furthermore, the drug delivery holes are provided in a plurality and are distributed at equal distances on the side of the end of the drug delivery tube.

[0009] Furthermore, the drug delivery holes are provided in a plurality and circumferentially distributed on the side of the end of the drug delivery tube.

[0010] Furthermore, the drug delivery hole is circular, strip-shaped, polygonal or other irregular shapes.

[0011] Furthermore, the end of the drug delivery tube is sealed.

[0012] Furthermore, the fixing piece passes through the side wall of the drug delivery tube and is detachably connected to the connecting piece in the drug delivery tube.

[0013] Furthermore, the connection between the fixing piece and the drug delivery tube is a snap-fit ​​connection.

[0014] Furthermore, the fixing member passes through the side wall of the drug delivery tube to form a connecting portion, and the connecting member passes through the connecting portion and is detachably connected to the connecting portion.

[0015] Furthermore, when the shape of the connecting piece is linear, the diameter is 0.1-0.5 mm, preferably 0.3 mm, and the length is the same as that of the drug delivery tube.

[0016] Furthermore, the fixing member is configured as a deformable coil, preferably any one of a nylon coil, a polypropylene coil or expanded polytetrafluoroethylene.

[0017] Nylon coils have strong corrosion resistance, are flexible and not easy to break, and can be used to fix drug delivery tubes; polypropylene coils or expanded polytetrafluoroethylene are both suture materials with high biocompatibility. Their fibers have high strength, moderate elongation, are non-toxic, and have good biocompatibility. Their use as fixings can reduce the impact on the intestines.

[0018] Furthermore, the connecting piece is made of metal or polymer material, preferably 0.3 mm stainless steel wire or 0.5 mm nylon wire.

[0019] Furthermore, the outer diameter of the sheath tube is 6-12 mm, the inner diameter is 3.5-7 mm, and the length is 1000-1500 mm; The drug delivery tube has an outer diameter of 2.5-4.5 mm, an inner diameter of 1-2 mm, and a length of 1500-3000 mm.

[0020] Furthermore, the outer diameter of the sheath tube is 10 mm, the inner diameter is 6 mm, and the length is 1200 mm; The drug delivery tube has an outer diameter of 3 mm, an inner diameter of 2 mm, and a length of 2000 mm.

[0021] Furthermore, the sheath tube and the drug delivery tube are configured as any one of PVC tubes, PU tubes, and PEBA tubes. The PVC tubes, PU tubes, and PEBA tubes are all made of corrosion-resistant and biocompatible materials, can be made into flexible pipes, reduce damage to the intestines, and can be used for long-term drug delivery.

[0022] Furthermore, the number of the fixing members is one or more.

[0023] Furthermore, the sheath tube is connected to the colonoscope via an elastic ring.

[0024] The second technical solution of the present invention is a drug administration method, which uses the intestinal flora transplantation drug administration device as described above to administer drugs, including the following steps: inserting a drug administration tube and a sheath tube into the intestine through a colonoscope; fixing the drug administration tube to the intestinal wall through a fixing piece; withdrawing the colonoscope and the sheath tube, and performing intestinal flora transplantation through the drug administration tube; after the drug administration course is completed, the connecting piece and the drug administration tube are removed in sequence, and the fixing piece eventually falls off naturally.

[0025] Furthermore, the fixing member is fixed in the intestine by a titanium clip in the colonoscope. Specifically, the titanium clip clamps the fixing member and the intestinal wall at the same time, thereby fixing the drug delivery tube.

[0026] Furthermore, when there are multiple fixing members, the titanium clips correspond to the fixing members one by one to fix them to the inner wall of the intestine.

[0027] Furthermore, after the sheath tube and the colonoscope exit the colon, the drug delivery tube is cut 100 mm away from the anus and fixed to the periphery of the anus with tape.

[0028] Furthermore, after the medication course is completed, the connector in the medication tube is first pulled out, the connection between the fixing member and the connector is disassembled, and the fixing member is separated from the medication tube.

[0029] Furthermore, after pulling out the connecting piece, slowly pull out the medication tube to ensure that the fixing piece is separated from the medication tube.

[0030] Furthermore, the titanium clip and the fixing device remain in the intestine, waiting for the titanium clip to fall off naturally and be discharged from the intestine.

[0031] (3) Beneficial effects Compared with the prior art, the present invention has the following advantages: (1) Reduce intestinal damage: Since the drug delivery tube and the external fixing part of the drug delivery tube used in the present invention enter the intestine with the colonoscope when they are sleeved inside the sheath tube, and the connecting part is arranged inside the drug delivery tube, the drug delivery tube used for intestinal drug delivery enters the intestine in a less damaging way; after the drug delivery is completed, the connecting part is first pulled out. This process does not damage the intestine, and the connection between the drug delivery tube and the fixing part is disassembled. Then the drug delivery tube is withdrawn. Since the drug delivery tube is no longer connected to the inside of the intestine at this time, the titanium clip will not be pulled when the drug delivery tube is withdrawn, causing damage to the intestinal wall; the titanium clip and the fixing part are finally discharged from the body by themselves. Since the fixing part is a nylon ring, it will not scratch the intestine. Therefore, the present invention reduces the damage to the intestine during intestinal drug delivery in many aspects.

[0032] (2) Reliable fixation: The colonoscope is used to guide the sheath tube directly to the ileocecal region, and the design of the deformable nylon coil fixed with a titanium clip ensures that the drug delivery tube is accurately anchored in the target intestinal area; the mechanical locking of the fixing part and the intestinal wall effectively prevents the displacement of the drug delivery tube, ensures the targeting of the flora transplantation, and avoids uneven distribution of drugs due to intestinal peristalsis.

[0033] (3) Long-term drug administration: The maximum length of the drug administration tube can be 3000mm, so the exposed part of the drug administration tube can be fixed around the anus after being cut off outside the body. Due to its sufficient length and suitable material, the drug administration tube can support multiple infusions during the drug administration process without repeated intubation; after the sheath tube is withdrawn, the outer diameter of the drug administration tube is very small, only 3.0mm, so long-term retention has little impact on the patient's activities, taking into account both the continuity of treatment and the comfort of life.

[0034] (4) Simple structure and low cost: Since the intestinal flora transplantation drug delivery device of the present invention has a simple structure and is easy to disassemble and assemble, and the materials used are all common materials on the market, including PVC tubes, stainless steel wires and nylon coils, the intestinal flora transplantation drug delivery device of the present invention can be customized in large quantities, is low in cost, and is easy to expand production. BRIEF DESCRIPTION OF THE DRAWINGS

[0035] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present application. For ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[0036] Figure 1 This is a schematic diagram of the overall structure of an intestinal flora transplantation drug delivery device of the present invention; Figure 2 This is a schematic structural diagram of a drug delivery tube in an intestinal flora transplantation drug delivery device according to the present invention; Figure 3 This is a cross-sectional view of a drug delivery tube in an intestinal flora transplantation drug delivery device according to the present invention; Figure 4 This is an enlarged cross-sectional view of a drug delivery tube in an intestinal flora transplantation drug delivery device according to the present invention.

[0037] In the figure: 1-sheath tube; 2-drug delivery tube; 21-drug delivery hole; 3-fixing piece; 31-fixing portion; 4-connecting piece. DETAILED DESCRIPTION

[0038] The present invention will be described in detail below with reference to the accompanying drawings and specific embodiments.

[0039] The following describes the embodiments of the present application through specific examples, and those skilled in the art can easily understand other advantages and effects of the present application from the contents disclosed in this specification. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. The present application can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present application. It should be noted that, in the absence of conflict, the features in the following embodiments and embodiments can be combined with each other. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without making creative work are within the scope of protection of this application.

[0040] It should be noted that various aspects of the embodiments within the scope of the appended claims are described below. It should be apparent that the aspects described herein can be embodied in a wide variety of forms, and any specific structure and / or function described herein is merely illustrative. Based on this application, it should be understood by those skilled in the art that an aspect described herein can be implemented independently of any other aspect, and two or more of these aspects can be combined in various ways. For example, any number and aspect described herein can be used to implement an apparatus and / or practice a method. In addition, other structures and / or functionalities other than one or more of the aspects described herein can be used to implement this apparatus and / or practice this method.

[0041] It should also be noted that the illustrations provided in the following embodiments are only schematic illustrations of the basic concept of the present application. The illustrations only show components related to the present application and are not drawn according to the number, shape and size of components in actual implementation. In actual implementation, the type, quantity and proportion of each component can be changed at will, and the component layout type may also be more complicated.

[0042] Additionally, in the following description, specific details are provided to provide a thorough understanding of the examples, however, one skilled in the art will appreciate that the examples can be practiced without these specific details.

[0043] The following describes the technical solutions provided by various embodiments of the present application in conjunction with the accompanying drawings. Example

[0044] See Figures 1 to 3 The present invention provides an intestinal flora transplantation drug delivery device, comprising a sheath tube 1 and a drug delivery tube 2 sleeved inside the sheath tube 1, two fixing parts 3 connected to the side of the drug delivery tube, and a connecting part 4 arranged inside the drug delivery tube.

[0045] The sheath tube 1 is connected to the colonoscope through an elastic ring, and enters the rectum and colon and reaches the ileocecal part as the colonoscope is operated.

[0046] Please refer again Figure 2 Three dosing holes 21 are provided on the side of the end of the dosing tube 2, and the three dosing holes 21 are distributed at equal distances on the side of the end of the dosing tube.

[0047] Please refer again Figure 3 Three fixing members 3 are detachably connected to the outside of the dosing tube 2 , and a connecting member 4 is detachably provided on the inside of the dosing tube 2 . The dosing tube 2 is connected to the fixing member 3 via the connecting member 4 .

[0048] Please refer again Figure 3 The fixing member 3 passes through the side wall of the drug delivery tube 2 to form a circular connecting portion 31, and the connecting member 4 passes through the connecting portion 31 to form a snap connection.

[0049] The sheath tube 1 is a PVC tube with an outer diameter of 10 mm, an inner diameter of 6 mm, and a length of 1200 mm; the drug delivery tube 2 is a PVC tube with an outer diameter of 3 mm, an inner diameter of 2 mm, and a length of 2000 mm; the fixing part 3 is configured as a deformable nylon coil; the connecting part 4 is configured as a stainless steel wire with a diameter of 0.3 mm and a length of 2000 mm, which is the same length as the drug delivery tube.

[0050] Please refer again Figure 1-Figure 3 When the intestinal flora transplantation drug delivery device of the present invention is used, the drug delivery tube 2 and the sheath tube 1 together with the fixing piece 3 and the connecting piece 4 are first sent into the intestine through a colonoscope; the titanium clip is sheathed on the fixing piece 3 to clamp the intestinal wall, and the drug delivery tube 2 is fixed to the intestinal wall. A total of three titanium clips are provided to fix the three fixing pieces 3 to the intestinal wall respectively. After the sheath tube 1 and the colonoscope exit the colon, the drug delivery tube 2 is cut 100 mm away from the outside of the anus, and the drug delivery tube 2 is fixed around the anus with tape, and intestinal flora transplantation is performed through the drug delivery tube 2; after the drug delivery course is over, the connecting piece 4 in the drug delivery tube 2 is first pulled out, and the connection between the fixing piece 3 and the connecting piece 4 is disassembled, and the fixing piece 3 is separated from the drug delivery tube 2. After pulling out the connecting piece 4, the drug delivery tube 2 is slowly pulled out to ensure that the fixing piece 3 is separated from the drug delivery tube 2. The titanium clip and the fixing piece 3 remain in the intestine, waiting for the titanium clip to fall off naturally and be discharged from the intestine.

[0051] The same or similar parts between the various embodiments in this specification can be referred to each other, and each embodiment focuses on the differences from other embodiments.

[0052] The above description is merely a specific embodiment of the present application, but the scope of protection of the present application is not limited thereto. Any changes or substitutions that can be easily conceived by a person skilled in the art within the technical scope disclosed in the present application should be included in the scope of protection of the present application. Therefore, the scope of protection of the present application should be based on the scope of protection of the claims.

Claims

1. An intestinal flora transplantation drug delivery device, characterized in that: It comprises a sheath tube (1) and a drug delivery tube (2) sleeved inside the sheath tube (1); The sheath tube (1) is connected to the colonoscope and enters the intestine through the colonoscope; A dosing hole (21) is provided at the side of the end of the dosing tube (2); a fixing piece (3) is detachably connected to the outside of the dosing tube (2); a connecting piece (4) is detachably provided on the inside of the dosing tube (2); and the dosing tube (2) is connected to the fixing piece (3) via the connecting piece (4).

2. The intestinal flora transplantation drug delivery device according to claim 1, characterized in that: The fixing member (3) passes through the side wall of the dosing tube (2) and is detachably connected to the connecting member (4) inside the dosing tube (2).

3. The intestinal flora transplantation drug delivery device according to claim 1, characterized in that: The connection between the fixing piece (3) and the drug delivery tube (2) is a snap-fit ​​connection.

4. The intestinal flora transplantation drug delivery device according to claim 2, characterized in that: The fixing member (3) passes through the side wall of the drug delivery tube (2) to form a connecting portion (31), and the connecting member (4) passes through the connecting portion (31) and is detachably connected to the connecting portion (31).

5. The intestinal flora transplantation drug delivery device according to claim 4, characterized in that: When the connecting piece (4) is in a linear shape, its diameter is 0.1-0.5 mm and its length is the same as that of the drug delivery tube.

6. The intestinal flora transplantation drug delivery device according to claim 1, characterized in that: The fixing member (3) is configured as a deformable coil.

7. The intestinal flora transplantation drug delivery device according to claim 1, characterized in that: The connecting piece (4) is made of metal or polymer material.

8. The intestinal flora transplantation drug delivery device according to claim 3, characterized in that: The outer diameter of the sheath tube (1) is 6-12 mm, the inner diameter is 3.5-7 mm, and the length is 1000-1500 mm; The drug delivery tube (2) has an outer diameter of 2.5-4.5 mm, an inner diameter of 1-2 mm, and a length of 1500-3000 mm.

9. The intestinal flora transplantation drug delivery device according to claim 1, characterized in that: The fixing member (3) is provided as one or more.

10. A method of drug administration, comprising administering the drug using the intestinal flora transplantation drug administration device according to claim 1, wherein: The method comprises the following steps: inserting a dosing tube (2) and a sheath tube (1) into the intestine through a colonoscope; fixing the dosing tube (2) to the intestinal wall through a fixing piece (3); withdrawing the colonoscope and the sheath tube (1), and performing intestinal flora transplantation through the dosing tube (2); and after the end of the dosing course, removing the connecting piece (4) and the dosing tube (2) in sequence, and the fixing piece (3) eventually falls off naturally.

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