CN107126306B - Gastric inducer and stent thereof - Google Patents
Gastric inducer and stent thereof Download PDFInfo
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- CN107126306B CN107126306B CN201710499167.0A CN201710499167A CN107126306B CN 107126306 B CN107126306 B CN 107126306B CN 201710499167 A CN201710499167 A CN 201710499167A CN 107126306 B CN107126306 B CN 107126306B
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- stent
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0036—Intragastrical devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
- A61F5/0003—Apparatus for the treatment of obesity; Anti-eating devices
- A61F5/0089—Instruments for placement or removal
Landscapes
- Health & Medical Sciences (AREA)
- Child & Adolescent Psychology (AREA)
- Obesity (AREA)
- Nursing (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Prostheses (AREA)
Abstract
The invention discloses a stomach deflector and a bracket thereof, wherein the bracket is a reticular tube which is made of braided wires and comprises an upper bracket section and a lower bracket section, and the outer diameter of the upper bracket section is larger than that of the lower bracket section. This scheme can provide good holding power, is fixed in the duodenum. The support has good compliance and fatigue resistance, has certain supporting force, has certain compliance, can be stably fixed on the duodenum for a long time, can move along with the movement of the duodenum, and does not damage the intestinal wall. And can be connected with duodenal tube for treating metabolic diseases such as diabetes and obesity. The stent has the advantages of good applicability, convenient manufacturing process, low cost and high production speed, is used for the stent of the alimentary canal, and can be connected with an implantable catheter.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to a gastric deflector and a digestive tract bracket thereof for treating endocrine diseases (such as diabetes, islet dysfunction, obesity and the like) or lower digestive tract diseases (such as inflammation and the like).
Background
Diabetes is a disease which is considered to be a serious disease in recent years, is one of the most important diseases, and is a metabolic disease characterized by hyperglycemia, which is caused by the fact that the living standard of modern civilized society is continuously improved, and people eat well, have rich nutrition, and have reduced activity after the life is abundant. It is caused by insulin secretion deficiency or impaired biological action, or both. Diabetes can lead to chronic damage, dysfunction of various tissues, especially the eyes, kidneys, heart, blood vessels, nerves. Diabetes is often accompanied by obesity and many complications, which pose a great threat to human health. The data show that the incidence of diabetes is 9.7% in adults over 20 years of age in china alone, with an incidence of about 1.5 million. It is known that common ways of improving obesity and diabetes are to control diet, increase exercise, and assist certain medication, which requires long-term adherence to the patient, and once diet control and exercise are stopped, repeated and weight regain are easily caused, and long-term medication or insulin use also brings about a heavy economic burden and inconvenience to the patient.
Another treatment is gastric bypass, which has very good effects on radically treating type two diabetes and improving obesity, and in 2001, the international diabetes consortium has formally recommended metabolic surgery (including gastric bypass) as a treatment method for obesity combined with type two diabetes, however, gastric bypass, which is a surgical operation, causes wounds to the human body, and thus has many risks such as: death, ileus, anastomotic stoma leakage, pulmonary embolism, deep vein thrombosis, portal vein injury, respiratory system, and the like.
At present, the structure similar to that of a stomach deflector is implanted in the gastrointestinal tract to treat diabetes, however, the stomach deflector has a complex structure, a plurality of pull wires are usually required to be operated simultaneously to realize the functions, and the stomach deflector is required to be guided in a professional way before operation, so that operation errors are likely to occur due to no abundant experience, discomfort of patients is increased, the operation is difficult, the manufacturing cost is high, and the problems of technical barriers are solved, so that the stomach deflector is difficult to popularize and apply in a large range in China, and therefore, a method for treating diabetes, which is free from more uncomfortable feeling for patients in implementation, is provided, or a device for treating diabetes, which has a simple structure, convenient operation and low cost, is provided to be a problem to be solved urgently.
In addition, the main component of the gastric inducer in the prior art is made of fluoroplastic, so that the processing performance is poor, and the processing into a large-diameter thin-wall tube is very difficult, and even if the processing can be performed, the processing cost is very high. The performance of the fluoroplastic determines that the material is hard, has poor comfort and compliance after implantation, is easy to cause nausea, vomiting and the like of patients after implantation, and can possibly cause injury to human bodies.
At present, some products similar to a stomach deflector structure are implanted in the gastrointestinal tract to treat diabetes at home and abroad, a soft catheter made of high polymer material is implanted in the duodenum, and the soft catheter is generally fixed on the duodenal bulbar portion through a small metal bracket. The product is currently produced by the american GI company and has been used clinically and in China there are many similar designs. The bracket is of a V-shaped or wave-shaped structure and is fixed on the duodenal bulbar portion through barbs. The risk of this design is that the barb pierces the duodenum, produces certain damage to human alimentary canal, and the barb can harm the esophagus easily when taking out, causes the esophagus to tear. If the catheter falls into the distal end of the duodenum carelessly, the jejunum, even the colon, intestinal obstruction is liable to be caused. A better design is needed to circumvent these risks.
Disclosure of Invention
In order to solve the above technical problems, an object of the present invention is to provide a gastric inducer and a stent thereof, which can provide good supporting force and be fixed to the duodenum. The support has good compliance and fatigue resistance, has certain supporting force, has certain compliance, can be stably fixed on the duodenum for a long time, can move along with the movement of the duodenum, and does not damage the intestinal wall. And can be connected with duodenal tube for treating metabolic diseases such as diabetes and obesity. The stent has the advantages of good applicability, convenient manufacturing process, low cost and high production speed, is used for the stent of the alimentary canal, and can be connected with an implantable catheter.
In view of the above problems in the prior art, the inventors of the present invention have studied carefully, and have found that the above problems can be sufficiently solved by braiding a tubular stent having a diameter varying by using elastic wires, and providing a supporting force by the elasticity and structure of elasticity in a braided path which is spiral around a central axis, thereby completing the present invention.
Specifically, the invention adopts the following technical scheme:
the bracket of the gastric inducer is characterized in that the bracket is a net-shaped pipe which is woven by weaving wires (103) and comprises an upper bracket section (101) and a lower bracket section (102), and the outer diameter of the upper bracket section (101) is larger than that of the lower bracket section (102).
Preferably, the braided wire is an elastic wire which accords with biocompatibility, and can be a metal wire, a high polymer material wire or a degradable material wire.
Preferably, a developing ring (106) is arranged on the upper support section (101) or the lower support section (102), and the support can be positioned under X-rays, wherein the developing ring is preferably platinum, gold or tantalum.
Preferably, a recycling line (105) is arranged on the upper section (101) of the bracket. Can be taken out under the endoscope by a special recoverer or a grasping forceps for an endoscope.
Preferably, the diameter of the upper bracket section (101) is 25-40 mm, the diameter is larger than that of the upper duodenal section, the diameter of the lower bracket section (102) is preferably 15-25 cm, the diameter is equivalent to that of the upper duodenal section, and the diameter of the upper bracket section (101) is 5-15 mm larger than that of the lower bracket section (102).
Preferably, the mesh tube is woven from one wire and is spiral clockwise or counterclockwise.
Preferably, the mesh tube has 10-30 heads.
Preferably, the upper support section (101) is in the shape of a trapezoid, sphere, ellipse or rectangle with rounded corners.
Preferably, the stent is fixedly connected to the membrane tube (31) by stitching, heat pressing, ultrasonic welding or laser welding.
The gastric inducer is characterized by comprising a shell, a release body and a pushing assembly, wherein the shell (1) is tubular, one end of the shell (1) is provided with a first opening (11), the other end of the shell is provided with a second opening (13), a membrane tube (31) which is to be released and is in a folded state and a bracket (32) as described above are arranged in the shell (1), the release body (2) is arranged at the first opening (11) and is connected with one end of the membrane tube (31), and the release body (2) is made of a material which can be digested, absorbed or dissolved by the intestinal tract of a human body; the pushing assembly comprises an inner tube (41), a middle tube (42) and an outer tube (43) which are sleeved in sequence and can move relative to each other, and a part of the inner tube (41) is positioned in the shell (1) and is connected with the release body (2); one end of the middle pipe (42) extends into the shell (1) through the second opening (13), and a stop piston (12) which is positioned in the shell (1) and used for pushing against the membrane pipe (31) is fixedly arranged at the end of the middle pipe (42); the outer tube (43) is positioned outside the shell (1) and one end of the outer tube is fixedly connected to the second opening (13); wherein the inner tube (41) moves towards an operator along the axial direction of the inner tube so as to enable the release body (2) to be separated from the shell (1), and the inner tube (41) and the middle tube (42) drive the membrane tube (31) to be separated from the shell and spread out and released at a designated position of the intestinal tract of a human body.
By adopting the technical scheme, the support has good compliance and fatigue resistance, has certain supporting force, has certain flexibility, can be stably fixed on the duodenum for a long time, can move along with the movement of the duodenum, and does not damage the intestinal wall. The bracket has the advantages of good applicability, convenient manufacturing process, low cost and high production speed. Is connected with the digestive tract membranous tube, implanted into the digestive tract, and can be used for treating metabolic diseases such as diabetes, obesity, etc. The stent of the present invention can be implanted into the digestive tract for treating endocrine diseases such as diabetes, islet dysfunction, obesity, etc., or lower digestive tract diseases such as inflammation, etc. Compared with the prior art, the stent can effectively reduce the risks of damage to digestive tract mucous membrane, easy tearing of esophagus, intestinal obstruction and the like of the existing products and designs. The implant has the advantages of good structural applicability, convenient manufacturing process, low cost, high production speed, guaranteed quality, convenient manufacturing and the like, and has good comfort and compliance after implantation without damaging human tissues. In addition, the bracket can be connected with an implantable membrane tube, so that the stimulation to the digestive tract can be reduced after the membrane tube is connected, and the lifting adjustment or the recovery of the bracket is safer and more convenient.
Drawings
FIG. 1 is a cross-sectional view of a structure of an embodiment of the present invention;
FIG. 2 is a schematic diagram of the overall structure of an embodiment of the present invention;
FIG. 3 is a cross-sectional view of a release body of one construction of an embodiment of the present invention;
FIG. 4 is a cross-sectional view of a release body of another construction according to an embodiment of the invention;
FIG. 5 is a schematic view of the implantable catheter of the present invention;
FIG. 6 is a schematic view of the structure of an embodiment of the stent of the present invention;
FIG. 7 is a schematic view of another embodiment of the stent of the present invention;
fig. 8 is a schematic structural view of still another embodiment of the stent of the present invention.
Reference numerals illustrate:
1-a shell 11-a first opening 12-a stopper piston 13-a second opening 14-a nut 2-a release body 22-an inner core 221-a membrane tube connecting portion 222-a main body portion 23-a housing 231-an annular step 31-a membrane tube 32-a bracket 41-an inner tube 411-a damper tube 412-a second protruding end 42-a middle tube 421-a first protruding end 43-an outer tube 44-a first handle 45-a luer 46-a second handle; 101-upper stent section 102-lower stent section 103-braided wire 104-number of heads 105-recovery wire 106-developing ring.
Detailed Description
Embodiments of the present invention are described in detail below, examples of which are illustrated in the accompanying drawings, wherein like or similar reference numerals refer to like or similar elements or elements having like or similar functions throughout. The embodiments described below by referring to the drawings are illustrative and intended to explain the present invention and should not be construed as limiting the invention.
In the description of the present invention, it should be understood that the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "upper", "lower", "front", "rear", "left", "right", "vertical", "horizontal", "top", "bottom", "inner", "clockwise", "counterclockwise", etc. indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings are merely for convenience in describing the present invention and simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, be configured and operated in a specific orientation, and thus should not be construed as limiting the present invention.
Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying a relative importance or implicitly indicating the number of technical features indicated. Thus, a feature defining "a first" or "a second" may explicitly or implicitly include one or more such feature. In the description of the present invention, unless otherwise specified, the meaning of "a plurality" is two or more, unless otherwise clearly defined.
In the present invention, unless explicitly specified and limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and may be, for example, fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention can be understood by those of ordinary skill in the art according to the specific circumstances.
In the present invention, unless expressly stated or limited otherwise, a first feature "above" or "below" a second feature may include both the first and second features being in direct contact, as well as the first and second features not being in direct contact but being in contact with each other through additional features therebetween. Moreover, a first feature being "above," "over" and "on" a second feature includes the first feature being directly above and obliquely above the second feature, or simply indicating that the first feature is higher in level than the second feature. The first feature being "under", "below" and "beneath" the second feature includes the first feature being directly under and obliquely below the second feature, or simply means that the first feature is less level than the second feature.
A gastric inducer as shown in fig. 1, comprising a casing, a release body, a pushing assembly and an implantable catheter, wherein the casing 1 is tubular, one end of the casing 1 is provided with a first opening 11, the other end is provided with a second opening 13, the casing 1 is provided with the implantable catheter to be released in a folded state, the release body 2 is arranged at the first opening 11 and is connected with one end of the membrane tube 31, and the release body 2 is made of a material which can be digested, absorbed or dissolved by the intestinal tract of a human body; the pushing assembly comprises an inner tube 41, a middle tube 42 and an outer tube 43 which are sleeved in sequence and can move relative to each other, and a part of the inner tube 41 is positioned in the shell 1 and is connected with the release body 2; one end of the middle tube 42 extends into the shell 1 through the second opening 13, and a stop piston 12 which is positioned in the shell 1 and used for pushing against the membrane tube 31 is fixedly arranged at the end of the middle tube 42; the outer tube 43 is located outside the housing 1 and has one end fixedly connected to the second opening 13; wherein the inner tube 41 moves toward the operator along the axial direction thereof to disengage the release body 2 from the housing 1, and the inner tube 41 and the middle tube 42 drive the membrane tube 31 to be released from the housing and deployed, and released at a designated position of the intestinal tract of the human body.
Wherein, the inner tube 41 moves to drive the release body 2 to move, thereby driving the membrane tube 31 to gradually expand the membrane tube 31, and the middle tube 42 moves along the axial direction thereof and drives the stop piston 12 to push the membrane tube 31 (i.e. push against the end of the membrane tube 31 which is not connected with the release body 2), so as to push the membrane tube 31 out of the housing 1.
The boss is arranged outside the second opening 13 of the housing 1 in a protruding manner, a nut 14 is screwed on the boss, the outer tube 43 passes through the nut 14 and is fixedly connected with the second opening 13 of the housing 1, and specifically, the fixing connection mode of the outer tube 43 and the second opening 13 can be bonding thermal shrinkage or other modes.
In this embodiment, each part of the housing 1 and the pushing component may be made of one or more composite materials of polyurethane, polyethylene and fluoropolymer, and has good support, pushing property, good toughness, smooth surface, and good pushing property under an endoscope or in a natural cavity of a human body, and is not easy to be folded, and has good operability.
Specifically, when the gastric inducer of this embodiment is used, a guide wire is introduced into the inner tube 41, an operator stretches the whole device from the mouth of the human body, and then the guide wire and the gastroscope cooperate to guide the casing 1 to the duodenum and/or the upper part of the pylorus near the pylorus of the stomach in the human body, wherein the guide wire plays a role in guiding and supporting the pushing component, and helps the inner tube 41 move in the esophagus and the gastrointestinal tract of the human body, so that the casing 1 and the membrane tube 31 are guided to smoothly reach the designated position. Then, the middle tube 42 and the inner tube 41 in the pushing assembly are operated to release the membrane tube 31 in the shell 1 into the intestinal tract of a human body, and meanwhile, the inner tube 41 is operated to drive the release body 2 to move so as to expand the membrane tube 31 in a folded state, and after entering the intestinal tract of the human body, the release body 2 made of a material which can be digested and absorbed by the intestinal tract of the human body can be dissolved or decomposed in a short time and finally digested and absorbed by the intestinal tract of the human body, so that the release process of the membrane tube 31 is completed, a membrane-shaped guide pipeline is formed on the inner wall of the intestinal tract of the human body, absorption of nutrients in the intestinal tract is prevented and slowed down, secretion of digestive enzymes is regulated, and therefore, the effects of regulating blood sugar, blood fat and controlling weight are achieved, and diabetes is further avoided. The release body 2 is composed of a material which is biosafety compliant to the human body, digestible or decomposable by the human body, and has no toxic or side effects to the human body, and may be composed of, for example, one or more compounds such as an edible gelling agent, soybean protein powder, starch, polysaccharide compound, glycerin, branched chain or pullulan. One or more of the above compounds are added at the time of formulation, and then water, fat-soluble substances and the like are combined, and cured in the corresponding mold to form a hard solid structure. Meanwhile, the release body 2 can be made of materials which can be dissolved in a human body and are not absorbed at all, but are completely discharged out of the body normally, so that the release body has no toxic or side effect on the human body.
As shown in fig. 3 to 4, the release body 2 includes an inner core 22 and an outer shell 23, the inner core 22 has a main body portion 222 and a membrane tube connecting portion 221 formed by extending the main body portion 222, and the membrane tube connecting portion 221 is fixedly connected with one end of the membrane tube 31; the shell 23 is covered outside the main body 222, and the shell 23 is connected with the first opening 11 and is easy to break under the stress.
Preferably, referring to fig. 3 and 4, the surface of the main body 222 of the inner core 22 and the surface of the outer shell 23 facing the direction of releasing the membrane tube 31 are rounded, so that the movement of the release body 2 in the intestinal tract of the human body is easier.
Specifically, referring to fig. 3 and 4, the outer wheel of the main body 222 is approximately spherical or hemispherical, and the outer contour of the outer shell 23 is shaped to match the outer contour of the main body 222 and is wrapped around the main body 222; in this embodiment, the outer contour of the main body 222 is approximately hemispherical, and the outer contour of the housing 23 is approximately hemispherical, however, the shape of the main body 222 and the housing 23 may be similar to a sphere or a semi-sphere.
Preferably, referring to fig. 3 and 4, the outer contour of the main body 222 is hemispherical, the membrane tube connecting portion 221 is connected to the plane portion of the main body 222, the outer shell 23 is hemispherical and covers the spherical portion of the main body 222, an annular step 231 is formed on the outer edge of the end surface of the hemispherical outer shell 23, and the annular step 231 abuts against the second opening 13 of the housing 1.
Specifically, referring to fig. 3 and 4, in the foregoing embodiments, the connection manner between the inner core 22 and the outer shell 23 may be a screw connection or a clip connection, specifically, fig. 3 shows that the inner core 22 and the outer shell 23 in a screw connection state, where the inner core 22 and the outer shell 23 each include a portion with an approximately spherical profile and a portion with a cylindrical profile, mutually meshed threads are disposed on the portions with cylindrical profiles of the inner core 22 and the outer shell 23, and fig. 4 shows that the inner core 22 and the outer shell 23 in a clip connection state, where the outer surface of the inner core 22 and the inner wall of the outer shell 23 are provided with clip structures capable of being clipped with each other, it should be noted that the connection manner between the inner core 22 and the outer shell 23 may be not limited to a screw connection or a clip connection manner, and taper fit or other connection manners may be adopted, for example, the outer shell 23 and the inner core 22 may be matched in a taper manner. Other similar structures are not described in detail herein.
Preferably, referring to fig. 2, one end of the inner tube 41 sequentially passes through the membrane tube connection part 221, the body part 222, and the outer shell 23 of the inner core 22, and protrudes from the first opening 11. The endoscope views the human intestinal tract from the extended end of the inner tube 41. In this embodiment, the inner tube 41 is tightly or interference-connected with the membrane tube connecting portion 221, the main body portion 222, and the outer shell 23 of the inner core 22, so that the inner tube 41 may drive the release body 2 to move in the release direction of the membrane tube 31 and draw the membrane tube 31 to expand and extend out of the housing 1, and of course, the membrane tube connecting portion 221, the main body portion 222, the outer shell 23, and the inner tube 41 may be connected in a variety of different manners.
Preferably, referring to fig. 2, a damping tube 411 is sleeved outside a portion of the inner tube 41 passing through the inner core 22, in this embodiment, the damping tube 411 is used to form a tight fit between the inner tube 41 and the inner core 22, and the damping tube 411 is used to increase the sliding friction between the release body 2 and the inner tube 41, so as to improve the capability of the inner tube 41 to pull the release body 2 to move.
In this embodiment, the damping tube 411 may be made of one or more elastic materials selected from polyurethane, silicone, TPE, etc., and the surface may be physically or chemically treated to increase friction, so that the damping tube 411 maintains a relatively static state between the release body 2 and the inner tube 41 before the membrane tube 31 is released.
Preferably, referring to fig. 2, the other end of the membrane tube 31 is fixedly connected with a support 32, the support 32 is an elastic memory alloy woven support 32 and has a net-shaped outline, specifically, the support 32 can be made of nickel-titanium alloy, stainless steel or other elastic metals, or other memory alloys meeting the requirements of biocompatibility, and the material can be suitable for long-term implantation of human bodies; the support 32 is arranged in a regular shape and structure like a diamond, a hexagon or a honeycomb, is placed on the duodenal bulbar portion of a human body, has certain elasticity, can deform along with intestinal peristalsis, has certain supporting force, and can be fixed on the duodenal bulbar portion.
Specifically, when the middle tube 42 is operated, the middle tube 42 moves the stopper piston 12 to push the holder 32 together with the membrane tube 31 outward from the housing 1, at which time the holder 32 in the housing 1 needs to be observed through the endoscope, and when the foremost end of the holder 32 has to be removed from the housing 1, the operation of the middle tube 42 should be stopped. At this time, the bracket 32 can be fixed on the duodenal bulbar portion of the human body when leaving the housing 1 by adjusting the position of the housing 1, and the bracket has a certain elasticity, can deform along with intestinal peristalsis, has a certain supporting force, and can be fixed on the duodenal bulbar portion.
Specifically, in the above embodiment, the specific structure of the movement of the tube 42, the inner tube 41 in operation includes: the middle tube 42 has a first protruding end 421 protruding from the other end of the outer tube 43, the first protruding end 421 is connected with a first handle 44, a luer 45 for communicating the outside with the inside of the middle tube 42 is provided on the first handle 44, the inner tube 41 has a second protruding end 412 protruding from the first protruding end 421, and the second protruding end 412 is connected with a second handle 46.
Specifically, in the process of moving the inner tube 41 and the inner tube 42 in operation to release the membrane tube 31, a certain amount of water or physiological saline can be injected into the luer connector 45, and the water or physiological saline enters the membrane tube 31 through the gap between the inner tube 41 and the inner tube 42, so that the release of the membrane tube 31 in the duodenum is accelerated, and the dissolution or decomposition of the release body 2 is accelerated. Specifically, when the membrane tube 31 is released, the membrane tube 31 and the release body 2 peristaltic along the intestinal tract of the human body from the duodenum to the jejunum for about 1-10 minutes. In this process, saline flows toward the membrane tube 31 along the gap between the inner tube 41 and the middle tube 42, which accelerates the peristaltic movement of the membrane tube 31 and the release body 2 toward the jejunum, thereby accelerating the release of the membrane tube 31. The film tube 31 may contain a developing material such as barium sulfate, bismuth carbonate, tungsten, or the like, and may be developed under X-rays, and the releaser 2 may also contain a developing material, and the position of the releaser 2 may be accurately shown under X-rays, so that the operator can operate the device conveniently.
The gastric inducer of the present invention may be operated by first, when an operator pulls the inner tube 41 in a direction approaching the operator so that the second opening 13 of the housing 1 presses the outer housing 23, the annular step 231 of the outer housing 23 breaks to disengage the release body 2 from the housing 1, then, operating the inner tube 41 to move the release body 2 away from the operator (i.e., the patient), thereby extending one end of the membrane tube 31 from the housing 1 and driving the membrane tube 31 to expand, and at this time, operating the middle tube 42 to drive the stopper piston 12 to move, the stopper piston 12 pushes the bracket 32 at the other end of the membrane tube 31 located in the housing 1, thereby pushing the membrane tube 31 as a whole out of the housing 1, and it should be noted here that when the membrane tube 31 has been fully expanded, when the stopper piston 12 pushes the support 32 to move to the first opening 11 of the housing 1 (the membrane tube 31 is about to be completely released), it is required to ensure that the support 32 also reaches a designated release position (specifically, a proper position of the duodenum near the pylorus of the stomach and/or the upper part of the pylorus of the stomach of the human body) in the intestinal tract of the human body, and then the second handle 46 is pushed away from the operator to completely release the support 32 from the housing 1, so that the support 32 is fixed on the duodenal bulb of the human body, has a certain elasticity and can deform along with the peristaltic movement of the intestinal tract, and a certain supporting force, and the time for placing the membrane tube 31 in the stretched state of the duodenal bulb in the digestive tract of the human body can be 1-12 months, and is adjusted according to the improvement condition or actual condition of the state of the patient.
In this embodiment, another operation mode may be adopted, in which the middle tube 42 and the inner tube 41 are operated simultaneously, so that the stopper piston 12 pushes one end of the membrane tube 31 located in the housing 1 to push the membrane tube 31 out of the housing 1, and the inner tube 41 moves to drive the release body 2 to move, and the release body 2 pulls the support 32 at the other end of the membrane tube 31, so that the membrane tube 31 is stretched out of the housing 1 while being stretched, and finally the membrane tube 31 is pushed out of the housing 1 in its entirety at a designated release position of the intestinal tract of the human body.
The implantable catheter, as shown in fig. 5, comprises a membrane tube (31), one end of the membrane tube (31) is connected with a bracket (32), and the membrane tube (31) comprises High Density Polyethylene (HDPE), low Density Polyethylene (LDPE), linear Low Density Polyethylene (LLDPE), barium sulfate and the like. Wherein the High Density Polyethylene (HDPE), also called low pressure polyethylene, refers to thermoplastic resin with the density of 0.940-0.976 g/cm 3 and the elastic modulus of 800-1200 MPa. Wherein the Low Density Polyethylene (LDPE) is also called high pressure polyethylene, and refers to thermoplastic resin with density within 0.910-0.940 g/cm 3, elastic modulus within 200-500MPa, and melt index within 0.2-0.5g/min. Wherein the Linear Low Density Polyethylene (LLDPE) refers to thermoplastic resin with the density in the range of 0.915-0.935 g/cm 3 and the elastic modulus in the range of 100-400 MPa.
Preferably, the weight ratio of the high density polyethylene, the low density polyethylene, the linear low density polyethylene and the barium sulfate may be 1.5:4:4:0.5, preferably 1:4:4:1, more preferably 0.5:4:4:1.5. Within this range, an implantable catheter of excellent performance can be obtained.
Preferably, the outer diameter of the membrane tube according to the invention may be 10mm to 40mm, preferably 15mm to 35mm, more preferably 15mm to 30mm. Within this range, the utility model is suitable for human digestive tract and will not hurt human tissue.
Preferably, the length of the membrane tube according to the invention may be 200mm to 1500mm, preferably 200mm to 1300mm, more preferably 300mm to 1200mm. Within this scope, the catheter according to the invention can be placed in any position of the digestive tract and define the active position.
Preferably, the wall thickness of the film tube according to the invention may be 0.001mm to 0.1mm, preferably 0.005mm to 0.05mm, more preferably 0.01mm to 0.03mm. Within this range, the flexibility of the catheter according to the present invention can be sufficiently ensured, and sufficient strength can be maintained.
The preparation method of the film tube comprises the steps of mixing high-density polyethylene, low-density polyethylene, linear low-density polyethylene and barium sulfate according to a certain weight ratio, and blowing.
The implantable catheter may be implanted in the alimentary canal. The alimentary canal includes the esophagus, stomach, duodenum, jejunum, ileum, etc., such that different locations of the implantable catheter may correspond to the esophagus, stomach, duodenum, jejunum, ileum, etc., respectively. Since the catheter has different functions at different locations, different effects can be exerted on different parts of the digestive tract. The implantable catheter can play a role in isolating food in intestinal tracts, change the physiological flow direction of the food, eliminate insulin resistance of the body of a patient after being implanted for a period of time, promote insulin secretion in the body of the patient, reduce islet apoptosis and increase the islet cells, and recover islet functions, so that metabolic diseases such as diabetes, obesity and the like are cured. The tensile modulus of the implantable catheter is more than 250MP, the elongation is more than 230 percent, the material is soft, and the phenomena of nausea, vomiting, abdominal pain and the like caused after the implantable catheter is implanted in a human body can be obviously reduced.
The implantable catheter according to the present invention may be implanted in the digestive tract for the treatment of endocrine diseases such as diabetes, islet dysfunction, obesity, etc., or lower digestive tract diseases such as inflammation, etc. Compared with the prior art, the implantable catheter has the advantages of simple structure, good structural applicability, convenient manufacturing process, low cost, high production speed, guaranteed quality, convenient manufacturing and the like, and has good comfort and compliance after implantation without damaging human tissues.
In addition, the implantable catheters described herein contain barium sulfate that has properties such as being visible under X-rays. Furthermore, the implantable catheters of the present invention may be connected to stents. The stimulation to the alimentary canal can be reduced after the bracket is connected, and the lifting adjustment or the recovery of the bracket is safer and more convenient.
As shown in fig. 5, the membrane tube 31 is connected to one end of the support 32 by one or more of stitching, hot pressing, ultrasonic welding, or laser welding.
As shown in fig. 6 to 8, the present embodiment provides a digestive tract stent 32 divided into an upper section 101 and a lower section 102, the diameter of the upper section 101 is preferably 25 to 40mm, which is larger than the diameter of the duodenal bulb, and the diameter of the lower section 102 is preferably 15 to 25cm, which is close to or slightly larger than the diameter of the duodenum. The diameter of the upper section 101 is greater than the diameter of the lower section 102, preferably the diameter of the upper section 101 is 5-15 mm greater than the diameter of the lower section 102.
Preferably, the stent may be funnel-shaped as shown in fig. 6, that is, the upper section 101 has an inverted trapezoid shape, and the diameter of the upper section 101 is greater than that of the lower section 102, preferably, the diameter of the upper section 101 is 25-40 mm, the diameter is greater than that of the upper section of the duodenum, the diameter of the lower section 102 is 15-25 cm, the diameter of the upper section is equivalent to that of the upper section of the duodenum, and the diameter of the upper section 101 is 5-15 mm greater than that of the lower section 102. The rounded rectangle of the upper segment 101 is fixed on the duodenal bulbar, the inverted trapezoid design can realize smooth transition, maximally avoid damage to the digestive tract wall caused by long-term implantation, and provide maximum supporting force, the lower segment is connected with the membrane tube, and the membrane tube 31 is prolonged to the lower segment of the duodenum or the upper segment of the jejunum.
Preferably, the stent 32 may be spherical in shape as shown in fig. 7, i.e., the upper section 101 is oval in shape, and the diameter of the upper section 101 is greater than the diameter of the lower section 102, preferably, the diameter of the upper section 101 is 25-40 mm, the diameter is greater than the diameter of the upper section of the duodenum, the diameter of the lower section 102 is 15-25 cm, and the diameter of the upper section 101 is 5-15 mm greater than the diameter of the duodenum. The upper segment 101 is fixed on the duodenal bulb part, the arc-shaped design can maximally avoid damage to the digestive tract wall caused by long-term implantation, the arc-shaped excessive can provide good supporting force, the lower segment 102 is connected with the membrane tube 31, and the membrane tube 31 is prolonged to the lower segment of the duodenum or the upper segment of the jejunum.
Preferably, the bracket is a wine glass, namely the upper section 101 is in a round rectangle shape, and the diameter of the upper section 101 is larger than that of the lower section 102, preferably, the diameter of the upper section 101 is 25-40 mm, the diameter is larger than that of the upper section of the duodenum, the diameter of the lower section 102 is 15-25 cm, the diameter is equivalent to that of the upper section of the duodenum, and the diameter of the upper section 101 is 5-15 mm larger than that of the lower section 102. The upper segment 101 is fixed on the duodenal bulbar portion in a round-corner rectangular shape, the contact area between the bracket and the duodenal bulbar portion is the largest due to the round-corner rectangular design, damage to the digestive tract wall caused by long-term implantation can be avoided to the greatest extent, the lower segment 102 is connected with a membrane tube, and the membrane tube is prolonged to the lower segment or the upper segment of the duodenum.
Preferably, the upper section 101 of the bracket 32 has a height of 5-15 mm, and the lower section 102 has a height of 5-15 mm, and the specific height can be slightly adjusted according to the specific physiological anatomy of the human body.
The support 32 is regularly arranged in a rhombic, hexagonal or honeycomb-shaped structure, is placed on the duodenal bulbar portion of a human body, has certain elasticity, can deform along with intestinal peristalsis, has certain supporting force, and can be fixed on the duodenal bulbar portion to prevent sliding.
The braided wire 103 of the stent 32 may be a metallic material, a polymeric material, or a degradable material. The metal wire material can be stainless steel wire or nickel titanium alloy wire, the polymer material can be polymer material such as PE (polyethylene), PU (polyurethane) or PTFE (polytetrafluoroethylene), and the degradable material can be PPDO (polydioxanone), PLLA (polylactic acid), PGA (polyglycolic acid) or the like. The material meets the requirement of biocompatibility, can be implanted in a human body for a long time, has good toughness and elasticity, has certain supporting force in the alimentary canal, is connected with the membrane tube 31, and can prevent the sliding down.
Preferably, the braided wire 103 is made of nickel-titanium alloy, and the nickel-titanium alloy wire is preferably made of nickel-titanium alloy meeting the requirement of long-term implantation, and the preferable austenite transformation point is 0-10 degrees.
The bracket 32 is woven on the mould through wires, and is shaped through heat treatment, and the shaped product can be the structure shown in fig. 6 to 8 or similar structures conforming to the physiological anatomy of human bodies. The device has certain supporting force and compression force in the transverse direction and the longitudinal direction, can deform along with the peristaltic movement of human intestinal tracts, has uniform supporting force, is fixed on the duodenal bulbar portion, can recover to a heat-set shape, and is fixed on the duodenal bulbar portion 113.
In particular the braided wire of the stent 32 is in the form of a convolution that rotates about a central axis. The rotation direction of the rotator may be a clockwise rotation direction or a counterclockwise rotation direction when viewed from the head end portion.
As shown in fig. 7, the stent 32 has a recovery wire 105, and the recovery wire 105 is sewn on the outermost ring of the upper section 101 of the stent 32, and the stent can be taken out from the body and recovered by a special recoverer or grasper. When the retrieval line is pulled in, the stent 32 is retracted entirely, into the transparent cap of the endoscope or a specific retrieval device, and removed from the human alimentary canal with the endoscope. The recovery line 105 may be made of PE, nylon, terylene, and other materials meeting the requirement of biocompatibility.
Preferably, the surface of the bracket 32 may be covered with a film to facilitate later removal. Preferably, the membrane can be made of various soft materials which are consistent with human body biocompatibility, such as silica gel, fluoroplastic, PE, TPU and the like. The thickness of the film is 0.01-0.2mm.
The stent 32 is woven from a single wire, preferably, the number of heads 104 of the stent 32 may be preferably 10-30, less preferably 15-25, and most preferably 18-24.
The support 32 is provided with a developing ring 106, which can be clearly positioned under X-rays, and the developing ring 106 can be made of heavy metal materials harmless to human bodies, such as platinum, gold, tantalum and the like.
In the description of the present specification, a description referring to terms "one embodiment," "some embodiments," "examples," "specific examples," or "some examples," etc., means that a particular feature, structure, material, or characteristic described in connection with the embodiment or example is included in at least one embodiment or example of the present invention. In this specification, schematic representations of the above terms do not necessarily refer to the same embodiments or examples. Furthermore, the particular features, structures, materials, or characteristics described may be combined in any suitable manner in any one or more embodiments or examples.
Although embodiments of the present invention have been shown and described above, it will be understood that the above embodiments are illustrative and not to be construed as limiting the invention, and that variations, modifications, alternatives, and variations may be made in the above embodiments by those skilled in the art without departing from the spirit and principles of the invention. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.
Claims (9)
1. The gastric inducer is characterized by comprising a shell, a release body and a pushing component, wherein the shell (1) is tubular, one end of the shell (1) is provided with a first opening (11), the other end of the shell is provided with a second opening (13), a membrane tube (31) and a bracket (32) which are to be released and are in a folded state are arranged in the shell (1), the release body (2) is arranged at the first opening (11) and is connected with one end of the membrane tube (31), and the release body (2) is made of a material which can be digested, absorbed or dissolved by the intestinal tract of a human body; the pushing assembly comprises an inner tube (41), a middle tube (42) and an outer tube (43) which are sleeved in sequence and can move relative to each other, and a part of the inner tube (41) is positioned in the shell (1) and is connected with the release body (2); one end of the middle pipe (42) extends into the shell (1) through the second opening (13), and a stop piston (12) which is positioned in the shell (1) and used for pushing against the membrane pipe (31) is fixedly arranged at the end of the middle pipe (42); the outer tube (43) is positioned outside the shell (1) and one end of the outer tube is fixedly connected to the second opening (13); wherein the inner tube (41) moves towards an operator along the axial direction of the inner tube so as to enable the release body (2) to be separated from the shell (1), and the inner tube (41) and the middle tube (42) drive the membrane tube (31) to be separated from the shell and spread out and released at a designated position of the intestinal tract of a human body;
The bracket is a reticular pipe which is woven by braiding wires (103) and comprises an upper bracket section (101) and a lower bracket section (102), wherein the outer diameter of the upper bracket section (101) is larger than that of the lower bracket section (102);
The release body (2) comprises an inner core (22) and an outer shell (23), wherein the inner core (22) is provided with a main body part (222) and a membrane tube connecting part (221) formed by extending the main body part (222), the membrane tube connecting part (221) is fixedly connected with one end of the membrane tube (31), and the other end of the membrane tube (31) is fixedly connected with a support (32); the shell (23) is coated outside the main body part (222), and the shell (23) is connected with the first opening (11) and is easy to break under stress; one end of the inner tube (41) sequentially passes through the membrane tube connecting part (221), the main body part (222) and the outer shell (23) of the inner core (22) and extends out of the first opening (11), and the inner tube (41) is in tight fit or interference connection with the membrane tube connecting part (221), the main body part (222) and the outer shell (23) of the inner core (22).
2. The gastric inducer of claim 1 wherein the braided filaments are biocompatible elastic filaments, are metal filaments, polymeric filaments, or degradable filaments.
3. The gastric inducer of claim 1 wherein the upper stent section (101) or the lower stent section (102) is provided with a developing ring (106).
4. A gastric inducer according to claim 1, wherein the upper section (101) of the support is provided with a recovery wire (105).
5. A gastric inducer as claimed in claim 1, wherein the upper stent section (101) has a diameter of 25-40 mm and a diameter greater than the upper duodenal section, the lower stent section (102) has a diameter of 15-25 cm, comparable to the diameter of the upper duodenal section, and the upper stent section (101) has a diameter of 5-15 mm greater than the lower stent section (102).
6. The gastric inducer of claim 1 wherein the mesh tube is woven from a single wire and is spiral clockwise or counterclockwise.
7. The gastric inducer of claim 1 wherein the mesh tube has a head count of 10-30 heads.
8. A gastric inducer according to claim 1, wherein the upper section (101) of the stent is of inverted trapezoidal, rounded spherical, oval or rounded rectangular shape.
9. A gastric inducer according to claim 1, wherein the stent (32) is fixedly connected to the membrane tube (31) by suturing, heat pressing, ultrasonic welding or laser welding.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710499167.0A CN107126306B (en) | 2017-06-27 | 2017-06-27 | Gastric inducer and stent thereof |
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|---|---|---|---|
| CN201710499167.0A CN107126306B (en) | 2017-06-27 | 2017-06-27 | Gastric inducer and stent thereof |
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| CN107126306B true CN107126306B (en) | 2024-05-14 |
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Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111356420B (en) * | 2017-10-25 | 2022-07-08 | 波士顿科学国际有限公司 | Noninvasive spacing support |
| CN108938163B (en) * | 2018-04-12 | 2023-12-26 | 杭州糖吉医疗科技有限公司 | Gastric inducer and method of releasing same |
| PL3777784T3 (en) * | 2018-04-12 | 2023-02-06 | Hangzhou Tangji Medical Technology Co., Ltd. | Gastric diverter and digestive tract support and release method thereof |
| CN108635092B (en) * | 2018-04-12 | 2020-06-16 | 杭州糖吉医疗科技有限公司 | Stomach divertor and alimentary canal support thereof |
| CN108464945B (en) * | 2018-05-03 | 2024-03-22 | 杭州糖吉医疗科技有限公司 | Duodenal internal jejunum sleeve release system and application method thereof |
| WO2020047878A1 (en) * | 2018-09-09 | 2020-03-12 | 上海医立泰生物科技有限公司 | Segmentation-type esophageal stent and weaving method therefor |
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| CN107126306A (en) | 2017-09-05 |
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