WO2016165593A1

WO2016165593A1 - Instrument for deep implantation in intestinal tract

Info

Publication number: WO2016165593A1
Application number: PCT/CN2016/078969
Authority: WO
Inventors: 张发明; 李潘; 季国忠; 彭炤源; 崔伯塔; 缪林
Original assignee: 南京法迈特科技发展有限公司; 张发明
Priority date: 2015-04-11
Filing date: 2016-04-11
Publication date: 2016-10-20
Also published as: CN104856888A; CN110710952A

Abstract

An instrument for deep implantation in an intestinal tract comprises a medication delivery tube (1) and a fixing line (2). The medication delivery tube (1) is a flexible and bendable tube made of a polymer material, and has openings at two ends thereof. One or more through holes (3) in communication with the inside of the medication delivery tube (1) are provided at a side of a distal end of the medication delivery tube (1) or on a side wall of the medication delivery tube (1). A tracer material is provided on or not provided on a tube wall of the medication delivery tube (1). The fixing line (2) is fixedly connected to the tube wall of the distal end of the medication delivery tube (1). The instrument for deep implantation in an intestinal tract can be passed to a deep portion of an intestinal tract and fixed thereto, satisfying both single-use and long-term use applications for a naso-intestinal tube, an anus-ileocecal region tube and an anus-ileum tube. The instrument for deep intestinal implantation has a smart structure, is easy-to-operate, safe, and effective, and can be left in place for a long time, thereby improving conventional implantation and fixing techniques.

Description

Intestinal deep implant device

Technical field

The invention belongs to the field of medical instruments, and in particular relates to a pipeline which is deeply implanted in the intestinal tract under endoscope and an auxiliary device thereof.

Background technique

The existing digestive tract administration, including gastrointestinal nutrition treatment, includes oral, gastric tube, gastroscope, nasal jejunal tube, transanal enema, direct input through endoscopy, and the like. Intraductal feeding is a simple and effective interventional treatment, including transnasal (usually containing duodenum and jejunum proximal) tube feeding, transanal enema tube feeding and so on. After the nasointestinal tube is mainly used for enteral nutrient solution infusion and drug feeding, it can be retained for a long time, but the infusion tube cannot be fixed in the intestinal wall, and it is easy to slip into the stomach or outside the body; It is only limited to clean enema, retention enema and local treatment of direct colon. It is usually taken out once and for all. Except for long-term retention in the intestine and outside, the scope of application is limited to the direct colon. Not only that, the traditional infusion pipeline has many shortcomings. For example, some pipelines need to be replaced by the replacement device in the nasal cavity after the endoscopic clamp is implanted into the duodenum, which brings the patient. Pain; some jejunal tubes are difficult to successfully place to the target position under endoscopy. Even if they can be reached, the catheter will be taken away from the target position when the mirror is removed.

Summary of the invention

The object of the present invention is to provide a deep intra-intestinal implant device which is clever in structure, convenient in operation, safe and effective, and can be retained for a long time, and can be mainly used for: (1) administration of ileum and whole colon to achieve full colon administration, and It is no longer local administration of the rectosigmoid colon, changing the path of traditional ileocolic disease treatment and the scope of intestinal administration; (2) endoscopically assisting the implantation of the hose in the duodenum, the distal segment can reach twelve The distal end of the intestine or the proximal end of the jejunum is used for nasal feeding and intra-intestinal administration through the tube, and effectively solves the problem of low efficiency of traditional endoscopic implantation of the nasal feeding tube.

In order to achieve the above object, the specific technical solution of the present invention is as follows:

An intra-enteral deep implant device comprising a drug delivery tube and a fixation line, the drug delivery tube being a flexible and bendable polymer material tube having open ends at the distal end side of the drug delivery tube or Providing one or more channels communicating with the inside of the drug delivery tube on the side wall of the drug delivery tube, with or without tracer material on the wall of the drug delivery tube; the fixation wire is fixedly attached to the drug delivery On the tube wall of the tube.

The instrument of the present invention may further comprise a guidewire and/or an extension. The distal end of the drug delivery tube in the device can be fixed in the digestive tract by a fixed line, the proximal end is located outside the nose or the anus, and the fixing line can be used for an auxiliary fixture such as a titanium clip. Fixing it to the intestinal wall, the length of the fixation line and the distance between the fixation line and the drug delivery tube and the distal end of the tube allow for further movement of the fixed administration tube in the intestinal tract. The proximal end of the drug delivery tube is used for inserting a guide wire, connecting an extension, connecting a joint, injecting a drug, etc., and the guide wire in the drug delivery tube can be used for guiding the catheter implantation, assisting the delivery when the endoscope exits, assisting the extubation, and seeing through the perspective The target wire, etc., can also be used to add an extension member to the short guide wire.

The drug delivery tube of the invention may have a length of 30.0 to 420.0 cm, a cross-sectional diameter of 1.0 to 8.0 mm, soft and elastic, bendable, and a smooth inner and outer surface of the tube, and the material thereof is polyethylene, silica gel and other polymer materials. The pipe wall may or may not have a tracer material, such as a metal wire that is impermeable to X-rays. The drug delivery tube has a channel on both end sides and a wall side. The channel preferably has two or more channels, and the shape of the channel may be circular, strip, polygonal or other irregular shape. In a preferred embodiment, the drug delivery tube has a length of 90.0 to 120.0 cm, has a front end opening, and has two side holes, an outer tube diameter of 2.0 to 4.0 mm, a polyethylene or silica gel material, and a tube wall having an impervious X. The metal wire of the light is provided with a hole having an opening direction toward the proximal end at a position of 1.0 cm or more from the distal end, and the tube wall may have a scale.

At the proximal end of the drug delivery tube, a joint may be further provided, one end of which is used for connecting the drug delivery tube, and the other end is used for connecting a drug pusher such as a syringe capable of introducing the drug into the digestive tract or other components, such as an extension piece. , quick connectors, etc.

The fixation line in the present invention is located at the distal end of the drug delivery tube, and may be at the distal opening or at the wall of the tube at a distance from the opening, for example, the connection between the fixation line and the drug delivery tube is from the end of the drug tube ( That is, the distal opening is 0 to 30.0 cm. The fixing line may have one or more annular structures, and the length of the fixing line is 5.0 to 10.0 cm, which is convenient for fixing the intestinal wall by using an auxiliary fixture such as a titanium clip under the endoscope, and the fixing line has a certain tensile force and pulling force. Stronger, the material can be a material such as nylon thread, gut line or polypropylene synthetic line. The fixing wire preferably has a length of 8.0 cm and is in the form of a double-ring, multi-ring or "8" structure, a nylon thread or a gut material, located at a distal portion of the drug delivery tube.

In the in-gut deep implant device of the present invention, the extension member may or may not be present, and when the extension member is not provided, the length of the drug delivery tube may be appropriately extended. When there is an extension, the proximal end of the drug delivery tube is movably connected to the extension. In general, the length of the extension is 30.0-300.0 cm, the cross section is directly 1.0-8.0 mm, and one end of the extension can be connected to the proximal end of the drug delivery tube. The extension member may be another tube of the same quality or different quality as the drug delivery tube, and the two drug delivery tubes may be connected by a guide wire or other connecting device, and the endoscope is used to assist the administration of the drug delivery tube into the digestive tract. If homogenous, the operator can cut off the excess tubing with scissors after implantation; the extension can also be a guide wire, and after the proximal end of the drug delivery tube is fixed, the donor tube is fed to the endoscope for digestion. Appropriate position; the extension can also be a pipe with a hardness slightly larger than that of the drug delivery tube. It is elastic, bendable, and has a smooth inner and outer surface. The material is polyethylene and other polymer materials. The pipe wall may or may not have a tracer substance. X-ray-proof metal wire. The extension is preferably another drug delivery tube.

The guidewire of the present invention is inserted into the drug delivery tube and is free to move forward and backward within the drug delivery tube, the cross section of the guide wire being smaller than the inner diameter of the drug delivery tube. The guide wire can be a flexible and bendable tissue material with good biocompatibility. Or a wire having a length of 30.0 to 420.0 cm. Further, the guide wire can be inserted into the drug delivery tube and the extension (pipe), soft and elastic, bendable, smooth surface, the material is a bio-tissue-compatible polymer material, and the guide wire can be in a short guide wire. Add an extension to the base. The preferred length of the guide wire is the same as or longer than the length of the administration tube, and the cross section thereof is smaller than the inner diameter of the administration tube. The material is metal or plastic, and can be inserted into the administration tube for guiding the tube implantation, assisting the delivery when the endoscope exits, Auxiliary extubation, perspective observation of the target, etc.

The deep intra-intestinal implant device of the invention can be sent to and fixed in the deep part of the intestine to meet the one-time and long-term use functions of the nasointestinal tube, the anus-ileile tube, the anal ileum tube, etc., and the structure is ingenious, convenient to operate and safe. It is effective, can be retained for a long time, and meets the needs of multiple administrations. It is greatly convenient for clinical applications such as nasal feeding tube implantation and whole colon administration, and will be widely used in clinical treatment.

DRAWINGS

BRIEF DESCRIPTION OF THE DRAWINGS Fig. 1 is a view showing the composition of each component of the present invention.

Figure 2 is a diagram showing the effect of digestive tract implantation of the present invention.

In the figure, 1-drug tube, 2-fixed wire, 3-drug hole, 4-joint, 5-extension, 6-guide wire, 7-joint.

detailed description

In order to explain the objectives, technical solutions, and advantages of the present invention, the embodiments of the present invention are described in detail below.

As shown in FIG. 1 , the present invention relates to an in-deep deep implant device comprising a drug delivery tube 1, a fixing wire 2, an extension member 5 and a guide wire 6, and the drug delivery tube 1 is made of polyethylene or silica gel and has elasticity. It can be bent and the inner and outer surfaces of the tube are smooth. An annular or linear X-ray opaque metal wire is provided on the drug delivery tube 1. The drug delivery tube has a plurality of drug ejection holes 3 on the end side and the wall side, and the drug dispensing holes 3 have a circular shape, a strip shape, a polygonal shape or other irregular shapes. The drug delivery tube 1 is open at both ends, and the proximal end of the drug delivery tube 1 may or may not be provided with a joint. The distal end of the drug delivery tube 1 is fixed with a fixing line 2, and the fixing line 2 has an "8" shape structure, which is convenient for fixing the intestinal wall by an auxiliary fixture such as a titanium clip under endoscope. When an extension is used, the extension 5 and the proximal end of the drug delivery tube 1 are joined at the joint 4. The guide wire 6 is a polymer material with good biocompatibility, soft and elastic, bendable and smooth; the guide wire 6 can be inserted into the extension 5 and the drug delivery tube 1 for guiding the catheter implantation, and the endoscope exits. The auxiliary joint can be connected to the proximal joint 4 of the drug delivery tube 1 or the proximal end of the extension 5, and the drug propelling device such as a syringe can pass through the joint 7 when assisting the delivery, assisting the extubation, seeing the target, and the like. Introduce the drug into the digestive tract. The joint 7 can be closed by a switching device when necessary, or can be connected to an instrument such as a syringe.

Example 1. Patients with ulcerative colitis treated with deep femoral implants and fecal bacteria transplantation

Ulcerative colitis is a chronic non-specific inflammatory disease of the colon and rectum. The lesions are mostly located in the sigmoid colon and rectum, and can also extend to the descending colon or even the entire colon. Fecal bacteria transplantation has been used in the treatment of ulcerative colitis, which can effectively relieve symptoms such as abdominal pain and diarrhea and maintain it during remission. Intra-intestinal deep implant instrument in this case, endoscopic The tube that can be implanted in the forceps includes a drug delivery tube 1, a fixing line 2, an extension member 5 and a guide wire 6, and the distal end of the drug delivery tube 1 is fixed with a fixed line 2, and the fixed line 2 has an "8" shape structure. The drug delivery tube has a plurality of drug delivery holes 3 on the end side and the wall side, the drug discharge hole 3 has a circular, star-shaped or polygonal opening, and the extension member 5 and the proximal end joint 4 of the drug delivery tube 1 are connected, and the guide wire 6 is connected. It can be inserted into the extension 5 and the drug delivery tube 1 for guiding the catheter implantation, assisting the delivery when the endoscope exits, assisting the extubation, seeing the target, etc., and the joint 7 can be connected to the proximal joint 4 of the drug delivery tube 1. The drug pushing device such as a syringe can introduce the drug into the digestive tract through the joint 7, and the joint 7 can be closed by a switch device when necessary, or can be connected to a device such as a syringe.

All colon examination by colonoscopy under general anesthesia, after the exploration of the colon lesion is clear, the assembly of the drug delivery tube 1, the extension 5, the guide wire 6 is sent through the endoscopic forceps, and the administration tube 1 of the assembly The distal end reaches the upper 5-10 cm of the lesion, and when the endoscope is withdrawn, the guide wire 6 is used to support the drug delivery tube 1 without exiting the intestinal lumen together with the endoscope, and then the enteroscopy is sent to the distal end of the drug delivery tube 1, through the endoscope Fix the fixation wire 2 of the drug delivery tube 1 to the upper 5-10 cm of the lesion in the intestinal cavity with a titanium clip under the forceps, withdraw the endoscope, remove the extension 5, and fix the proximal end of the drug delivery tube 1 to the patient outside the patient. A suitable site, if desired, can be attached to the proximal end of the drug delivery tube 1, at which point the drug delivery tube 1 completes the process of implantation into the digestive tract, as shown in FIG.

When a fecal transplant treatment is required, the syringe containing the fecal liquid is directly connected to the proximal end of the drug delivery tube 1 or connected to the administration tube 1 through the joint 7, and at this time, the fecal liquid can be introduced into the syringe 1 In the patient's digestive tract, the purpose of covering the entire colon with fecal bacteria is achieved.

When the administration tube 1 needs to be taken out, the professional physician can directly pull out the administration tube 1 to which the titanium clip is fixed.

Example 2. Complete colonic mesalazine enema in patients with inflammatory bowel disease

The in-gut deep implant device of this example specifically relates to a novel endoscopic clampable implantable tube, including a drug delivery tube 1, a fixation line 2, an extension member 5 and a guide wire 6, and a drug delivery tube 1 The distal end is fixed with a fixed line 2, and the fixed line 2 has an "8" shape structure. The end side and the wall side of the drug feeding tube have a plurality of medicine discharging holes 3, and the medicine discharging hole 3 has a circular, star-shaped or polygonal opening. The extension 5 is connected to the proximal joint 4 of the drug delivery tube 1, and the guide wire 6 can be inserted into the extension 5 and the drug delivery tube 1 for guiding the catheter implantation, assisting the delivery when the endoscope exits, assisting the extubation, and seeing through Observing the target or the like, the joint 7 can be connected to the proximal joint 4 of the drug delivery tube 1, and the drug pushing device such as a syringe can introduce the drug into the digestive tract through the joint, and the joint 7 can be closed by a switch device when needed, or can be connected to the syringe. And other appliances.

After general anesthesia, the digestive tract examination is performed by colonoscopy. After the digestive tract lesions are clearly examined, the assembly tube of the drug delivery tube 1, the extension member 5, and the guide wire 6 is fed through the endoscope clamp, and the administration tube of the assembly is 1 The distal end reaches the upper 5 cm of the lesion, and when the endoscope is withdrawn, the guide wire 6 is used to support the drug delivery tube 1 without exiting the intestinal lumen together with the endoscope, and then the colonoscopy is taken to the distal end of the drug delivery tube 1, and the endoscope is clamped. The fixation wire 2 at the distal end of the drug delivery tube 1 is fixed to the upper 5 cm of the lesion in the intestinal cavity using a titanium clip, the endoscope is withdrawn, the extension 5 is removed, and the proximal end of the drug delivery tube 1 is fixed to the outside of the patient. The site, then can be injected into the drug delivery tube 1 daily into the mesalazine solution, until the end of the 1-2 weeks of treatment can be removed, such as figure 2.

The tube can also be used to enter a large amount of clear water and clear the intestines, and to inject other drugs that need to be used.

Example 3, endoscopic duodenal implantation of a nasointestinal tube

The in-gut deep implant device of this example specifically relates to a novel endoscopic clampable implantable tube, including a drug delivery tube 1, a fixation line 2, an extension member 5 and a guide wire 6, and a drug delivery tube 1 The distal end is fixed with a fixed line 2, and the fixed line 2 has three coil structures. The end side and the wall side of the drug feeding tube have one medicine discharging hole 3, and the medicine discharging hole 3 has a circular, star-shaped or polygonal opening, and is extended. The piece 5 is connected to the proximal joint 4 of the drug delivery tube 1, and the guide wire 6 can be inserted into the extension 5 and the drug delivery tube 1 for guiding the catheter implantation, assisting the delivery when the endoscope exits, assisting the extubation, and seeing through The target or the like, the joint 7 can be connected to the proximal joint 4 of the drug delivery tube 1, and the drug pushing device such as a syringe can introduce the drug into the digestive tract through the joint, and the joint 7 can be closed by a switch device when needed, or can be connected to a syringe or the like. appliance.

After general anesthesia, the digestive tract examination is performed by colonoscopy. After the digestive tract lesions are clearly examined, the assembly of the drug delivery tube 1, the extension member 5, the guide wire 6 is sent through the gastroscopic clamp, and the administration tube 1 of the assembly is The distal end reaches the horizontal part of the duodenum, and the guide wire 6 is used to support the drug delivery tube 1 when exiting the endoscope. The lens is not returned to the outside of the mouth together with the endoscope, and then the mirror is sent to the duodenum, and the medicine is seen under direct vision. The tube 1 is fixed at a distance of 30 cm from the end of the 2 wire loop, and the fixing wire 2 at the distal end of the drug delivery tube 1 is fixed to the intestinal wall by a titanium clip under the endoscope clamp, and the endoscope is retracted while the extension piece is pulled out. The proximal end of the drug delivery tube 1 is fixed to a suitable part outside the patient's body, and then the nutrient solution can be injected into the drug delivery tube 1 every day until the end of the treatment period, as shown in Fig. 2.

The tube can also be used to input fecal bacteria, contrast agents, and the like.

There are many other embodiments of the present invention, and those skilled in the art can make various changes in accordance with the present invention, but such modifications are intended to fall within the scope of the appended claims.

Claims

An in-guin deep implant device characterized in that it comprises a drug delivery tube and a fixation line, the drug delivery tube being a flexible and bendable polymer material tube having open ends at the distal end of the drug delivery tube One or more channels communicating with the inside of the drug delivery tube are provided on the end side or on the side wall of the drug delivery tube, with or without tracer material on the tube wall of the drug delivery tube; Said on the wall of the drug delivery tube.
The enteric deep implant device according to claim 1, wherein a guide wire capable of freely moving forward and backward in the administration tube is bored in the administration tube; the guide wire has a cross section smaller than the administration tube Inner diameter.
The enteric deep implant device of claim 1 wherein a proximal end of the drug delivery tube is provided with a joint operatively coupled to an extension.
The intraintestinal deep implant device of claim 3 wherein said extension member is a flexible and bendable tube or guidewire.
The in-guin deep implant device according to claim 1, wherein the drug delivery tube has a length of 30.0 to 420.0 cm and a cross-sectional diameter of 1.0 to 8.0 mm, and the inner and outer surfaces of the tube are smooth.
The in-guin deep implant device according to claim 5, wherein the drug delivery tube has a length of 90.0 to 120.0 cm and a cross-sectional diameter of 2.0 to 4.0 mm.
The in-guin deep implant device according to claim 2, wherein the guide wire is a fibrous material or wire having a flexible and bendable bio-tissue property, and the length thereof is 30.0 to 420.0. Cm.
The in-guin deep implant device according to claim 1, wherein said fixing wire has one or more annular structures, and the length of the fixing wire is 5.0 to 10.0 cm; and the distance between the fixing wire and the drug delivery tube is The end of the tube is 0 to 30.0 cm.
The in-guin deep implant device of claim 8, wherein the fixation line is in the form of a double loop, a multi-ring or an "8".
The in-guin deep implant device according to claim 1 or 5, wherein the tracer substance is a metal line that is impermeable to X-rays.