CN108938163B - Gastric inducer and method of releasing same - Google Patents
Gastric inducer and method of releasing same Download PDFInfo
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- CN108938163B CN108938163B CN201810336514.2A CN201810336514A CN108938163B CN 108938163 B CN108938163 B CN 108938163B CN 201810336514 A CN201810336514 A CN 201810336514A CN 108938163 B CN108938163 B CN 108938163B
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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
- A61F5/0036—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
- A61F5/0013—Implantable devices or invasive measures
- A61F5/0076—Implantable devices or invasive measures preventing normal digestion, e.g. Bariatric or gastric sleeves
Abstract
The invention discloses a gastric inducer and a release method thereof, comprising a storage tube shell, a release body and a pushing component, wherein a digestive tract bracket is provided with a pre-unfolding shape and a post-unfolding shape and comprises an upper bracket, a lower bracket and a connecting piece; under the shape after expansion, the lower carriage is arranged below the upper carriage, the upper carriage and the lower carriage are connected through a plurality of connecting pieces, a fourth opening of the lower carriage is connected with the membrane tube, and the upper carriage and the lower carriage after expansion can not pass through the opened gastric pylorus opening, and the connecting pieces can pass through the gastric pylorus opening or penetrate through the gastric pylorus opening. Thus, the digestive tract bracket is divided into two parts for fixation, one part is fixed at the pylorus of the stomach, the upper end of the membrane tube is firmly positioned in the digestive tract when the digestive tract peristalsis is carried out, the other part is fixed at the duodenal bulbar part, and the lower-segment extension membrane tube is prevented from easily returning into the stomach when the digestive tract peristalsis is carried out, so that food does not flow according to a designed channel.
Description
Technical Field
The invention relates to the technical field of medical appliances, in particular to a gastric deflector for treating endocrine diseases (such as diabetes, islet dysfunction, obesity and the like) or lower gastrointestinal diseases (such as inflammation and the like) and a release method thereof.
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.
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. However, the mesh stent made of the known materials is easy to proliferate and adhere if not covered by a film, so that the mesh stent is difficult to take out after being implanted for a period of time, and the covered stent is easy to fall off.
The existing products of the American GI company and domestic similar patent designs are characterized in that the bracket is designed into a V shape and is provided with barbs and fixed on the duodenal bulbar part in the form of barbs, the design has the advantages of being suitable for most patients, but has certain problems in that the barbs are too long to cause perforation of the digestive tract and are too short to fall off easily, the design has about 10 percent of falling rate clinically according to the clinical literature of the American GI company, and the design is taken out and implanted and can cause a certain proportion of tearing and bleeding of the digestive tract under the condition of accidental falling off, so that certain using risks exist. 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.
Patent documents publication nos. CN103298518, CN105263439, WO2017/052694, etc. disclose an intragastric device comprising: a porous structure comprising a top, a bottom, and an interior and having a pre-deployment shape with a first volume and a post-deployment shape with a second volume that is larger than the first volume, wherein in the post-deployment shape the porous structure comprises at least one first opening adjacent the top and at least one second opening adjacent the bottom such that food enters the porous structure through the at least one first opening, passes through the interior, and exits the porous structure through the at least one second opening; and a sleeve having a flexible elongate body, a proximal end having a third opening, a distal end having a fourth opening, and a sleeve interior, wherein the sleeve is coupled to the porous structure such that food exiting the at least one second opening enters the sleeve through the third opening, passes through the sleeve interior, and exits the sleeve through the fourth opening. The porous structure (stent) is in the shape of a cylinder, an ellipsoid, a sphere cube or a cuboid after being expanded, occupies a relatively large volume in the stomach and can freely move in the stomach, the diameter of the porous structure is larger than that of an opened pylorus, and a sleeve (membrane tube) at the bottom of the porous structure extends to the duodenum through the pylorus. The intragastric device further includes an anti-migration component positioned at the junction of the porous structure and the sleeve and attached to either the porous structure or the sleeve or both, wherein the anti-migration component includes a compressed pre-deployment configuration and an expanded post-deployment configuration and is designed to be adjacent to the pylorus of the patient and to prevent migration of the porous structure to and through the pylorus. In the structure, the spherical bracket is arranged in the stomach and outside the pylorus, the sleeve (membrane tube) is arranged in the pylorus, the action mechanism is mainly to implant a netlike spherical memory alloy woven device in the stomach, the spherical bracket is covered with a membrane, the spherical bracket occupies a certain volume in the stomach to form a satiety, and food can be stored in the spherical bracket for a certain time, so that the intake of the food is reduced, the effect of treating obesity, diabetes and other metabolic diseases is achieved, and the membrane tube for food drainage is of a secondary functional structure. However, the above-described intragastric device has the following problems: firstly, the self-expanding memory alloy material has certain mechanical force and weight, and when the volume is large enough to occupy the internal volume of the stomach, the self-expanding memory alloy material has certain compression to the stomach, and the self-expanding memory alloy material is implanted into the stomach to compress gastric mucosa, so that digestive tract ulcer is very easy to cause; secondly, the food stays in the saccule for a long time, and although the gastric emptying can be slowed down, bacteria are easy to breed and inflammatory reaction is caused; thirdly, the device is not fixed in the pylorus opening or the duodenal bulbar part, and the lower section of the extension membrane tube is very easy to return into the stomach due to the reverse peristalsis of the digestive tract, so that food does not flow according to the designed channel; fourthly, the membrane tube at the pylorus opening has larger volume, and particularly after food is contained, the pylorus foreign body sensation is obvious and symptoms such as untight pylorus closure, bile reflux and the like are easily caused.
Patent documents with publication numbers of CN102335052, CN104382671, CN204671331, CN205359721 and the like disclose a digestive tract stent, wherein a main body is formed by connecting a plurality of stent units with certain rigidity and supporting function and connecting parts easy to bend, two ends of each connecting part are respectively connected with corresponding stent units, and the main body is in a straight cylinder structure easy to bend or a complex structure easy to bend, which is composed of a cylinder and a cone; the support unit is an integral structure formed by engraving metal pipes or a structure formed by weaving wires, the connecting part is formed by weaving metal wires or plastic wires with good flexibility, and the connecting wires are generally vertically woven with the planes of the upper support and the lower support. The stent is used for treating the stenosis or obstruction of the alimentary canal, plays roles of expanding and supporting the stenosis, is generally implanted into the alimentary canal as an independent product, is not connected with a membrane tube, and cannot be used as a gastric inducer because the stent has high supporting strength and is not easy to deform, so the stent cannot be used for the pylorus opening in the stomach.
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 release method thereof, wherein a digestive tract stent of the gastric inducer is composed of two parts, one part is fixed at a pylorus orifice of a stomach and the other part is fixed at a duodenal bulbar portion. The support can provide certain supporting force, but has certain flexibility, and the support can ensure that the upper section opening of the extension section membrane tube is fixed on the duodenal bulbar part, can be opened and closed along with the opening and closing of intestinal tracts, and cannot damage intestinal walls. The extended membrane tube can be used for treating metabolic diseases such as diabetes and obesity by isolating food. 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.
Aiming at the problems in the prior art, the inventor of the invention designs a two-section bracket through careful study, and weaves the bracket by using an elastic wire material, and the bracket and the film tube are easy to fall off or be easy to proliferate through fixing two sides of a pylome and a duodenal bulbar, and coating the film on the outer layer to prevent tissue proliferation, and the bracket and the film tube have smooth outer edges and no damage to human tissues. Thus, the present invention has been completed.
Specifically, the invention adopts the following technical scheme:
the gastric inducer comprises a storage tube shell (13), a release body and a pushing component, wherein the storage tube shell (13) is tubular, two ends of the storage tube shell (13) are provided with openings, a membrane tube (7) which is to be released and is in a folded state and the digestive tract support are arranged in the storage tube shell (13), the release body is arranged at the opening of the far end of the storage tube shell (13) and is connected with one end of the membrane tube (7), and the release body is made of a material which can be digested, absorbed or dissolved by human intestinal tracts; the digestive tract stent has a pre-deployment shape and a post-deployment shape, and comprises an upper stent (1), a lower stent (2) and a connecting piece (3); under the shape after expansion, upper bracket (1) is equipped with first opening near its top and is equipped with the second opening near its bottom, upper bracket (1) below is located in lower bracket (2), lower bracket (2) is equipped with the third opening near its top and is equipped with the fourth opening near its bottom, connect through a plurality of connecting piece (3) between upper bracket (1) and lower bracket (2), membrane pipe (7) is connected to the fourth opening of lower bracket (2), and, upper bracket (1) after expansion and lower bracket (2) all can't be through the stomach pylorus mouth that opens (i.e. the external diameter of upper bracket (1) after expansion and lower bracket (2) is greater than the stomach pylorus mouth external diameter that opens), connecting piece (3) can pass through the stomach pylorus mouth or wear to establish in stomach pylorus mouth department. Thus, the digestive tract bracket is divided into two parts for fixation, one part (upper bracket) is fixed at the pylorus of the stomach, the upper end of the film tube is firmly positioned in the digestive tract when the digestive tract peristalsis is carried out, the other part (lower bracket) is fixed at the duodenal bulbar part, and when the digestive tract peristalsis is carried out, the film tube is prevented from being easily returned into the stomach by the lower section of the extended film tube, so that food does not flow according to the designed channel. The support can provide certain supporting force, but has certain flexibility, and the support can ensure that the upper section opening of the extension section membrane tube is fixed on the duodenal bulbar part, can be opened and closed along with the opening and closing of intestinal tracts, and cannot damage intestinal walls. The extended membrane tube can be used for treating metabolic diseases such as diabetes and obesity by isolating food. 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.
Preferably, the pushing assembly comprises an inner tube (18), a middle tube (17) and an outer tube (16) which are sleeved in sequence and can move relative to each other, and a part of the inner tube (18) is positioned in the containing tube shell (13) and is connected with the release body; one end of the middle tube (17) extends into the storage tube shell (13) through a proximal end opening of the storage tube shell (13), and a pushing block (14) which is positioned in the storage tube shell (13) and used for pushing the membrane tube (7) is fixedly arranged at the end of the middle tube (17); the outer tube (16) is positioned outside the accommodating tube shell (13) and one end of the outer tube is directly or indirectly fixedly connected to the proximal end opening of the accommodating tube shell (13); wherein the inner tube (18) moves towards an operator along the axial direction of the inner tube so as to enable the release body to be separated from the storage tube shell (13), and the inner tube (18) and the middle tube (17) drive the membrane tube (7) to be separated from the storage tube shell (13) and unfolded and released.
Preferably, the housing tube (13) is provided with a marking line (25) which is 2 to 5cm from the distal opening of the housing tube (13). Thus being convenient for respectively releasing the upper bracket and the lower bracket inside and outside the pylorus opening.
Preferably, the release body comprises a release body shell (11) and a release body inner core (12), wherein the release body shell (11) is arranged at the far end opening of the storage tube shell (13), the release body inner core (12) is connected with the inner tube (18), and the release body shell (11) is coated outside the release body inner core (12).
Preferably, the connector (3) is a connecting wire. The connecting line can be in a linear shape or in a thin strip shape with a smaller sectional area, so that the connection of the upper bracket and the lower bracket can be ensured, and the food flow is not influenced. In addition, in other embodiments, the connecting piece can also be a flexible membrane tube, an elastic tube with a mesh structure, a connecting belt or a connecting sheet with flexibility or elasticity, and the like, but even if the connecting piece is reduced, the connecting piece is still large in size, so that the stomach pylorus is not tightly closed and the patient is uncomfortable, and therefore, the connecting wire is preferable. The connecting wire can be metal wires, such as nickel-titanium alloy, 304 stainless steel and the like, or polymer wires with good elasticity and fatigue resistance, such as polyethylene, nylon and the like.
Preferably, the connecting wire is covered with an outer surface film. Thus, the contact between the connecting wire and the digestive tract tissue is isolated, the friction damage is reduced, and the occurrence probability of gastric ulcer is reduced. The connecting wire is coated with film elastic material to prevent the connecting wire from damaging the humor door ring due to the sharp. Preferably, the elastic material of the coating film can be one or more materials such as silica gel, polyurethane and the like.
Preferably, the connecting piece (3) comprises a plurality of connecting wires, the upper ends of the plurality of connecting wires are respectively connected with the upper bracket (1), and the lower ends of the plurality of connecting wires are respectively connected with the lower bracket (2). Therefore, the upper and lower supports are connected up and down by adopting the connecting wires, so that the stress distribution is more uniform, and the fixing is more reliable.
Preferably, the connecting piece (3) is elastically deformed to conform to the bending of the pylorus or the reduction of the outer diameter of the human body in a natural state at the position corresponding to the pylorus of the stomach. Thus, when the pylorus of the stomach of the human body is in a basic closed state, the naturally-extending shape of the connecting piece can conform to the structures of the pylorus and the lower part of the human body, the pylorus can not be opened, the pylorus structure is damaged, the connecting piece can be extended when being under tensile force up or down, but has a shape memory function, and the original shape can be restored when the tensile force up or down is lost.
Preferably, the upper bracket (1) is in a cone shape, an inverted cone shape, a straight cylinder shape or a straw hat shape. Thus, the longitudinal section view of the upper bracket is rectangular or trapezoidal, or the two sides of the upper bracket are arc-shaped like rectangular or trapezoidal, and the first opening, the second opening and the exposed corners of the upper bracket can be rounded to avoid damaging tissues. Of course, in other embodiments, the upper support may be spherical or otherwise shaped.
Preferably, the second opening outer diameter of the upper bracket (1) is larger than the first opening outer diameter. Therefore, the upper bracket has the characteristics that the opening at the lower end is relatively large, the upper bracket can be clamped at the pylorus opening without damaging pylorus tissues, and the upper bracket and the lower bracket are provided with two openings, so that food can pass through but does not have the function of storing the food. The upper bracket is used for clamping the lower bracket at the pylorus opening to indirectly pull the membrane tube in the duodenum, so that the membrane tube is prevented from moving downwards or even being discharged in the peristaltic process of the digestive tract. The diameter of the upper bracket and the lower bracket is larger than that of the pylorus, and the diameter is preferably 20-50mm. The diameter of the upper orifice is preferably 20-30mm. The height of the upper support is preferably 5-15mm.
Preferably, the lower bracket has a cylindrical structure. The lower support structure is located inside the pylorus, specifically the duodenal bulb, and the main function of the structure is to have an opening for the extended membrane tube through which food can enter the membrane tube; secondly, in order to prevent the membrane tube from turning into the stomach from the duodenum, the position of the membrane tube is fixed corresponding to the upper bracket; and thirdly, the upper bracket and the lower bracket are respectively limited inside and outside the pylorus opening of the stomach, so that the upper bracket can not move freely in the stomach and is connected with the lower bracket and the membrane tube, and the upper bracket only has a small amount of displacement at the pylorus opening, thereby avoiding discomfort. The outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower bracket are preferably the same, so that the lower bracket is in a straight cylinder shape, the longitudinal section view of the lower bracket is rectangular or round-corner rectangular, and a small round corner can be arranged on the upper side and the lower side of the lower bracket, and the lower bracket is mainly used for preventing tissue damage. The outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower support can be different, namely the side wall of the lower support can have a certain taper or radian so as to adapt to the duodenal bulbar structure and be convenient for connecting the membrane tube.
Preferably, the diameter of the lower bracket is 15-25 cm, the diameter of the lower bracket is matched with the diameter of the duodenal bulbar of a human body, and the height of the lower bracket is 5-20mm. Preferably 10mm, which is as small as possible to achieve maximum comfort level for the human body, while satisfying the above functions.
The distance between the lower end of the upper bracket and the upper end of the lower bracket is 20-60mm, and the proper size is optimized according to different anatomical structures of a human body, the principle is that the distance is larger than the height of a pylorus ring, and the lower end of the lower bracket is required to avoid a duodenal papilla.
The upper and lower brackets are net-shaped structures which can be processed by weaving or cutting processes, and the net-shaped structures can be diamond-shaped, honeycomb-shaped, Z-shaped and other shapes. The structure enables the bracket to be compressed and expanded freely in the transverse direction and the longitudinal direction, and has good elasticity. Preferably, the upper bracket (1) and the lower bracket (2) are both woven by elastic wires (4), and the outer surfaces of the elastic wires (4) are coated, or the whole outer surfaces of the upper bracket (1) and the lower bracket (2) are respectively coated. The contact of the stent wire and the tissue in the stomach can be isolated, the friction damage is reduced, the occurrence probability of gastric ulcer is reduced, the tissue proliferation is prevented, and the high polymer material film can be one or more of medical materials such as silica gel, TPU, TPE and the like. 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.
The lower bracket is fixedly connected with the membrane tube through stitching, hot pressing, ultrasonic welding or laser welding.
Preferably, the upper end of the connecting wire is fixedly connected with the top of the upper bracket (1) close to the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket (2) close to the third opening. The optimized mode can avoid the bottom shrinkage of the upper bracket from affecting fixation when the alimentary canal bracket bears the up-down tension, and the bottom of the upper bracket is in elastic surface contact support with the outside of the pylorus mouth of the stomach, thereby reducing or avoiding the damage of connecting wires and the upper bracket to the alimentary canal tissues.
Preferably, the upper end of the connecting wire is fixedly connected with the top of the upper bracket (1) close to the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket (2) close to the third opening after the connecting wire winds around meshes woven in the middle of the upper bracket (1). Therefore, the further preferable mode can avoid the upper bracket from turning up and down to influence fixation when the digestive tract bracket bears up and down pulling force, and the upper bracket is in elastic surface contact support with the outside of the pylorus of the stomach, so that the damage of digestive tract tissues can be reduced or avoided.
Preferably, developing rings (6) are arranged on the upper bracket (1) and the lower bracket (2), the brackets can be positioned under X rays, and the developing rings are preferably platinum, gold or tantalum.
Preferably, an upper bracket recovery line (8) is arranged on the upper bracket (1), and a lower bracket recovery line (9) is arranged on the lower bracket (2). The digestive tract stent and the membranous tube can be removed by a special retriever or a grasper for an endoscope.
A method of releasing a gastric inducer, comprising the gastric inducer as described above, and the steps of:
1) The membrane tube and the alimentary canal bracket which are in a folded state are arranged in the accommodating tube shell (13), and the far-end opening of the accommodating tube shell (13) is closed by a release body;
2) Under the guidance of a guide wire, a release body at the far end of the storage tube shell (13) is sent into the duodenum, and then the release body and the membrane tube are pushed out of the storage tube shell;
3) Then the storage tube shell is retracted until the marking line reaches the valve opening, the lower support is pushed out of the storage tube shell, and the lower support is left at the duodenal bulbar part;
4) And then the storage tube shell is retracted, the upper support is pushed out of the storage tube shell, and the upper support is left outside the claustrade entrance to finish release.
By adopting the technical scheme, the upper bracket of the alimentary canal bracket can be fixed at the pylome, the lower bracket can be fixed at the duodenal bulbar, the membrane tube can be ensured to be stably fixed in the duodenum for a long time, and human tissues can not be damaged. And the outer layer of the bracket is covered with a film, so that the friction between the bracket and tissues can be reduced, the tissue proliferation caused by long-term implantation is avoided, and the later-stage extraction is convenient. And one end of the upper bracket fixed at the pylorus opening is arranged at the pylorus opening, and the other end is arranged in the stomach, so that the gastric emptying time can be delayed, and compared with the traditional gastric deflector or the duodenal sleeve, the upper bracket has better curative effect in the aspect of treating metabolic diseases such as diabetes, obesity and the like. 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. 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 bracket can effectively prevent the proliferation of tissues after implantation, can be fixed at the positions of the pylorus and the duodenal papilla for a long time, and can not cause damage to human digestive tracts. 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 schematic view of a gastric inducer according to the present invention;
FIG. 2 is an enlarged schematic view of the distal end of the gastric inducer of the present invention;
FIG. 3 is a side view of the expanded structure of example 1 of the alimentary canal stent of the present invention (single-wire straw hat stent);
FIG. 4 is a front view of the deployment structure of example 1 of the digestive tract stent of the present invention (single-wire straw hat stent);
FIG. 5 is a side view of the expanded configuration of example 2 of the alimentary canal stent of the present invention (a double-wire straw hat stent);
FIG. 6 is a front view of an expanded configuration of embodiment 2 of the alimentary canal stent of the present invention (a double-wire straw hat stent);
FIG. 7 is a side view of the expanded structure of example 3 of the alimentary canal stent of the present invention (tri-linear ladder stent);
FIG. 8 is an elevation view of the expanded structure of example 3 of the digestive tract stent of the present invention (tri-wire ladder stent);
FIG. 9 is a side view of the expanded configuration of embodiment 4 of the alimentary canal stent of the present invention (double-sided inverted trapezoidal stent);
FIG. 10 is a side view of an expanded configuration of embodiment 5 of the alimentary canal stent of the present invention (a double-wire ladder stent);
FIG. 11 is a side view of an expanded configuration of example 6 of the alimentary canal stent of the present invention (a double-line circular arc stent);
FIG. 12 is a schematic view of the expanded configuration of the membrane tube and the alimentary canal stent of the present invention;
Fig. 13 is a schematic view of the placement of the membrane tube and the alimentary canal stent of the present invention within the alimentary canal of a human body.
Reference numerals illustrate: 1-an upper bracket; 2-a lower bracket; 3-connectors; 4-elastic yarn; 5-a protective film; 6-developing ring; 7-membrane tube; 8-an upper bracket recovery line; 9-a lower bracket recovery line; 11-a release body housing; 12-a release body core; 13-housing the tube shell; 14-pushing blocks; 15-screw cap; 16-an outer tube; 17-middle tube; 18-an inner tube; 21-a rear handle; 22-middle handle; 23 limiting ball heads; 24 front handle; 25 marking lines; 101-stomach; 102-a pylome; 103-duodenal bulbar; 104-duodenal papilla; 105-duodenum; 106 jejunum.
Description of the embodiments
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.
The gastric deflector as shown in fig. 1 and 2 comprises a storage tube shell 13, a release body and a pushing component, wherein the storage tube shell 13 is tubular, two ends of the storage tube shell 13 are provided with openings, a membrane tube 7 and a digestive tract bracket which are to be released and are in a folded state are arranged in the storage tube shell 13, the release body is arranged at the opening of the distal end of the storage tube shell 13 and is connected with one end of the membrane tube 7, and the release body 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 pipe 18, a middle pipe 17 and an outer pipe 16 which are sleeved in sequence and can move relative to each other, and a part of the inner pipe 18 is positioned in the storage pipe shell 13 and is connected with the release body; one end of the middle tube 17 extends into the storage tube shell 13 through a proximal end opening of the storage tube shell 13, and a pushing block 14 which is positioned in the storage tube shell 13 and used for pushing the membrane tube 7 is fixedly arranged at the end of the middle tube 17; the outer tube 16 is located outside the storage tube shell 13 and one end of the outer tube is directly or indirectly fixedly connected to the proximal opening of the storage tube shell 13; wherein, the inner tube 18 moves towards the operator along the axial direction so as to disconnect the release body from the storage tube shell 13, and the inner tube 18 and the middle tube 17 drive the membrane tube 7 to be separated from the storage tube shell 13 and be unfolded and released.
The housing tube 13 is provided with a marking line 25 which is 2 to 5cm from the distal opening of the housing tube 13. The release body comprises a release body shell 11 and a release body inner core 12, wherein the release body shell 11 is arranged at the far end opening of the storage tube shell 13, the release body inner core 12 is connected with the inner tube 18, and the release body shell 11 is coated outside the release body inner core 12.
An alimentary canal stent of a gastric deflector as shown in fig. 3 to 11, having a pre-deployment shape and a post-deployment shape, comprising an upper stent 1, a lower stent 2 and a connector 3; under the shape after expansion, upper bracket 1 is equipped with first opening near its top and is equipped with the second opening near its bottom, and upper bracket 1 below is located to lower carriage 2, and lower carriage 2 is equipped with the third opening near its top and is equipped with the fourth opening near its bottom, connects through a plurality of connecting piece 3 between upper bracket 1 and the lower carriage 2, and membrane tube 7 is connected to the fourth opening of lower carriage 2 to, and, upper bracket 1 after expansion and lower carriage 2 all can't pass through the stomach pylorus mouth that opens (i.e. the external diameter of upper bracket 1 after expansion and lower carriage 2 is greater than the stomach pylorus mouth external diameter that opens), and connecting piece 3 can pass through the stomach pylorus mouth or wear to establish in stomach pylorus mouth department. Thus, the bracket is fixed in two parts, one part (upper bracket) is fixed at the opening of the stomach, the upper end of the film tube is firmly positioned in the digestive tract when the digestive tract peristalsis is carried out, the other part (lower bracket) is fixed at the duodenal bulbar part, and when the digestive tract peristalsis is carried out, the film tube is prevented from being easily returned into the stomach by the lower section of the film tube, so that food does not flow according to the designed channel. The support can provide certain supporting force, but has certain flexibility, and the support can ensure that the upper section opening of the extension section membrane tube is fixed on the duodenal bulbar part, can be opened and closed along with the opening and closing of intestinal tracts, and cannot damage intestinal walls. The extended membrane tube can be used for treating metabolic diseases such as diabetes and obesity by isolating food. 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.
The connecting piece 3 is a connecting wire. The connecting line can be in a linear shape or in a thin strip shape with a smaller sectional area, so that the connection of the upper bracket and the lower bracket can be ensured, and the food flow is not influenced. In addition, in other embodiments, the connecting piece can also be a flexible membrane tube, an elastic tube with a mesh structure, a connecting belt or a connecting sheet with flexibility or elasticity, and the like, but even if the connecting piece is reduced, the connecting piece is still large in size, so that the stomach pylorus is not tightly closed and the patient is uncomfortable, and therefore, the connecting wire is preferable. The connecting wire can be metal wires, such as nickel-titanium alloy, 304 stainless steel and the like, or polymer wires with good elasticity and fatigue resistance, such as polyethylene, nylon and the like.
The connecting wire is covered with a film. Thus, the contact between the connecting wire and the digestive tract tissue is isolated, the friction damage is reduced, and the occurrence probability of gastric ulcer is reduced. The connecting wire is coated with film elastic material to prevent the connecting wire from damaging the humor door ring due to the sharp. Preferably, the elastic material of the coating film can be one or more materials such as silica gel, polyurethane and the like.
The connecting piece 3 comprises a plurality of connecting wires, the upper ends of the connecting wires are respectively connected with the upper bracket 1, and the lower ends of the connecting wires are respectively connected with the lower bracket 2. Therefore, the upper and lower supports are connected up and down by adopting the connecting wires, so that the stress distribution is more uniform, and the fixing is more reliable.
The connecting member 3 is elastically deformed in a natural state in correspondence with the position of the pylorus of the stomach or in conformity with the curvature of the pylorus of the human body or in accordance with the reduced outer diameter. Thus, when the pylorus of the stomach of the human body is in a basic closed state, the naturally-extending shape of the connecting piece can conform to the structures of the pylorus and the lower part of the human body, the pylorus can not be opened, the pylorus structure is damaged, the connecting piece can be extended when being under tensile force up or down, but has a shape memory function, and the original shape can be restored when the tensile force up or down is lost.
The upper bracket 1 is in a cone shape, an inverted cone shape, a straight cylinder shape or a straw hat shape. Thus, the longitudinal section view of the upper bracket is rectangular or trapezoidal, or the two sides of the upper bracket are arc-shaped like rectangular or trapezoidal, and the first opening, the second opening and the exposed corners of the upper bracket can be rounded to avoid damaging tissues. Of course, in other embodiments, the upper support may be spherical or otherwise shaped.
The second opening outer diameter of the upper bracket 1 is larger than the first opening outer diameter. Therefore, the upper bracket has the characteristics that the opening at the lower end is relatively large, the upper bracket can be clamped at the pylorus opening without damaging pylorus tissues, and the upper bracket and the lower bracket are provided with two openings, so that food can pass through but does not have the function of storing the food. The upper bracket is used for clamping the lower bracket at the pylorus opening to indirectly pull the membrane tube in the duodenum, so that the membrane tube is prevented from moving downwards or even being discharged in the peristaltic process of the digestive tract. The diameter of the upper bracket and the lower bracket is larger than that of the pylorus, and the diameter is preferably 20-50mm. The diameter of the upper orifice is preferably 20-30mm. The height of the upper bracket 1 is preferably 5-15mm.
The lower support is of a cylindrical structure. The lower support structure is located inside the pylorus, specifically the duodenal bulb, and the main function of the structure is to have an opening for the extended membrane tube through which food can enter the membrane tube; secondly, in order to prevent the membrane tube from turning into the stomach from the duodenum, the position of the membrane tube is fixed corresponding to the upper bracket; and thirdly, the upper bracket and the lower bracket are respectively limited inside and outside the pylorus opening of the stomach, so that the upper bracket can not move freely in the stomach and is connected with the lower bracket and the membrane tube, and the upper bracket only has a small amount of displacement at the pylorus opening, thereby avoiding discomfort. The outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower bracket are preferably the same, so that the lower bracket is in a straight cylinder shape, the longitudinal section view of the lower bracket is rectangular or round-corner rectangular, and a small round corner can be arranged on the upper side and the lower side of the lower bracket, and the lower bracket is mainly used for preventing tissue damage. The outer diameter of the upper opening (third opening) and the outer diameter of the lower opening (fourth opening) of the lower support can be different, namely the side wall of the lower support can have a certain taper or radian so as to adapt to the duodenal bulbar structure and be convenient for connecting the membrane tube.
The diameter of the lower bracket is 15-25 cm, the lower bracket is matched with the diameter of the duodenal bulbar of a human body, and the height of the lower bracket is 5-20mm. Preferably 10mm, which is as small as possible to achieve maximum comfort level for the human body, while satisfying the above functions.
The upper end of the connecting wire is fixedly connected with the top of the upper bracket 1 close to the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket 2 close to the third opening. The optimized mode can avoid the bottom shrinkage of the upper bracket from affecting fixation when the alimentary canal bracket bears the up-down tension, and the bottom of the upper bracket is in elastic surface contact support with the outside of the pylorus mouth of the stomach, thereby reducing or avoiding the damage of connecting wires and the upper bracket to the alimentary canal tissues.
The upper end of the connecting wire is fixedly connected with the top of the upper bracket 1 near the first opening, and after the connecting wire winds the middle part of the upper bracket 1 to weave meshes, the lower end of the connecting wire is fixedly connected with the top of the lower bracket 2 near the third opening. Therefore, the further preferable mode can avoid the upper bracket from turning up and down to influence fixation when the digestive tract bracket bears up and down pulling force, and the upper bracket is in elastic surface contact support with the outside of the pylorus of the stomach, so that the damage of digestive tract tissues can be reduced or avoided.
The distance between the lower end of the upper bracket and the upper end of the lower bracket is 20-60mm, and the proper size is optimized according to different anatomical structures of a human body, the principle is that the distance is larger than the height of a pylorus ring, and the lower end of the lower bracket is required to avoid a duodenal papilla.
The upper and lower brackets are net-shaped structures which can be processed by weaving or cutting processes, and the net-shaped structures can be diamond-shaped, honeycomb-shaped, Z-shaped and other shapes. The structure enables the bracket to be compressed and expanded freely in the transverse direction and the longitudinal direction, and has good elasticity. Preferably, the upper bracket 1 and the lower bracket 2 are both made of elastic wires 4, and the outer surfaces of the elastic wires 4 are covered with films, or the whole outer surfaces of the upper bracket 1 and the lower bracket 2 are respectively covered with films. The contact of the stent wire and the tissue in the stomach can be isolated, the friction damage is reduced, the occurrence probability of gastric ulcer is reduced, the tissue proliferation is prevented, and the high polymer material film can be one or more of medical materials such as silica gel, TPU, TPE and the like. 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.
The lower bracket is fixedly connected with the membrane tube through one or more of hot melting, hot pressing, ultrasonic welding, high-frequency welding, stitching or laser welding.
Preferably, the upper end of the connecting wire is fixedly connected with the top of the upper bracket 1 near the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket 2 near the third opening. The optimized mode can avoid the bottom shrinkage of the upper bracket from affecting fixation when the alimentary canal bracket bears the up-down tension, and the bottom of the upper bracket is in elastic surface contact support with the outside of the pylorus mouth of the stomach, thereby reducing or avoiding the damage of connecting wires and the upper bracket to the alimentary canal tissues.
Preferably, the upper end of the connecting wire is fixedly connected with the top of the upper bracket 1 near the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket 2 near the third opening after the connecting wire winds around the middle part of the upper bracket 1 to weave meshes. Therefore, the further preferable mode can avoid the upper bracket from turning up and down to influence fixation when the digestive tract bracket bears up and down pulling force, and the upper bracket is in elastic surface contact support with the outside of the pylorus of the stomach, so that the damage of digestive tract tissues can be reduced or avoided.
The gastric inducer includes a transporter and a built-in cannula. The conveyer consists of a handle and a conveying catheter, and the built-in sleeve consists of a digestive tract bracket and a membranous tube. The built-in cannula enters the human body through the conveyor and remains in the duodenum. In the invention, the digestive tract bracket consists of an upper bracket 1 and a lower bracket 2, and the middle is connected with a connecting piece 3. The upper and lower stents 1, 2 may be braided from a resilient wire material or cut from a tubular material, which may be a medical implantable material such as one or more of nickel titanium alloy, 316 stainless steel, polyurethane, aluminum magnesium alloy, and the like.
The stent is woven or cut into a net structure, the net opening can be of various structures such as diamond, hexagon and the like, and the stent can be freely stretched and compressed in the transverse direction and the longitudinal direction and can be spontaneously restored to a preset shape and size.
The upper bracket 1 can be fixed at the pylorus, the diameter of the opening at the lower end is larger than the maximum diameter of the opening of the pylorus, and the shapes include but are not limited to various shapes shown in figures 3, 5, 7, 9, 10 and 11, and the principle is that the upper bracket can be fixed outside the pylorus and does not fall into the pylorus, but does not affect the normal functions of the stomach and the pylorus and does not damage the wall of the digestive tract. Different stents can be selected according to actual needs in clinic.
Preferably, the lower opening bracket of the upper bracket 1 is larger than the diameter of the pylorus opening, and the diameter is preferably 20-50mm. The diameter of the upper orifice is preferably 20-30mm. The height of the upper support is preferably 5-15mm.
The lower bracket 2 is mainly used for being connected with the membrane tube, and the upper end of the membrane tube is kept in an opening state after the ball part is opened, so that chyme can enter the membrane tube and is isolated from the alimentary canal wall. The shape of the lower bracket 2 is designed to be mainly in accordance with the size of the duodenal bulb, and is slightly larger than the diameter of the bulb.
Preferably, the diameter of the lower opening of the lower bracket 2 is larger than that of the pylorus, and the diameter is preferably 20-30mm. The diameter of the upper orifice is preferably 20-30mm. Slightly larger than the diameter of the duodenal bulbar part of a human body. The height of the lower support 2 is preferably 5-15mm.
The function of the connecting wires is to connect the upper bracket 1 and the lower bracket 2, and the number of the connecting wires can be 1, 2, 3 or more as shown in fig. 3 to 8. The main function is to connect the upper bracket 1 and the lower bracket 2, when the lower bracket 2 moves downwards along with the membrane tube 7, the upper bracket 1 can be pulled by the upper bracket 1 through the connecting piece 3, and when the upper bracket 1 floats upwards, the lower bracket 2 can be pulled by the connecting piece 3.
The connecting piece 3 can be made of a material meeting the requirement of human implantation, and can be one or more materials such as nickel-titanium alloy, 316 stainless steel, polyurethane, silica gel, aluminum-magnesium alloy and the like.
In order to protect the pylorus from being cut or injured by the connector 3, the connector 3 is coated with a biocompatible soft material, preferably one or more of silicone, polyurethane, polyethylene, etc.
In order to prevent hyperplasia and reduce damage to tissues caused by stent friction, the upper stent 1 and the lower stent 2 are covered with protective films. The protective film must be a material that meets the requirements of human implantation. Preferably, the material of the coating film can be one or more materials of silica gel, polyurethane, polyethylene and the like.
The distance between the upper bracket 1 and the lower bracket 2 is a certain distance, preferably, the distance between the lower end of the upper bracket 1 and the upper section of the lower bracket 2 is 20-60mm, and the proper size is preferred according to different anatomical structures of a human body, the principle is that the distance is larger than the height of a pyloric ring, and the lower end of the lower bracket 2 is required to avoid a duodenal papilla 104.
The upper bracket 1 and the lower bracket 2 are provided with developing rings 6 which can be clearly positioned under X-rays, and the developing rings can be made of heavy metal materials such as platinum, gold, tantalum and the like which are harmless to human bodies.
The upper ends of the upper bracket 1 and the lower bracket 2 are respectively provided with an upper bracket recovery line 8 and a lower bracket recovery line 9, the upper bracket recovery line 8 and the lower bracket recovery line 9 are respectively sewed on the outermost rings of the upper bracket 1 and the lower bracket 2, and the brackets can be taken out from the body and recovered through a special recoverer or a grasping forceps. When the recovery line is pulled in, the upper bracket 1 and the lower bracket 2 are respectively retracted, and enter the transparent cap of the endoscope or a specific recovery device, and are taken out from the alimentary canal of the human body along with the endoscope. The upper bracket recovery line 8 and the lower bracket recovery line 9 can be made of PE, nylon, terylene and other materials meeting the requirement of biocompatibility.
A method of releasing a gastric inducer, comprising the gastric inducer as described above, and the steps of:
1) The membrane tube and the alimentary canal bracket in the folded state are arranged in the accommodating tube shell 13, and the distal end opening of the accommodating tube shell 13 is closed by a release body;
2) Under the guidance of the guide wire, the release body at the far end of the storage tube shell 13 is sent into the duodenum, and then the release body and the membrane tube are pushed out of the storage tube shell;
3) Then the storage tube shell is retracted until the marking line reaches the valve opening, the lower support is pushed out of the storage tube shell, and the lower support is left at the duodenal bulbar part;
4) And then the storage tube shell is retracted, the upper support is pushed out of the storage tube shell, and the upper support is left outside the claustrade entrance to finish release.
Before use, the membrane tube and the alimentary canal stent are compressed and received in a receiving tube housing 13, the distal end being closed by a release body housing 11 and a release body core 12. When in use, the distal release body enters the duodenum of a human body under the guidance of the guide wire. After the release body is unlocked, the middle tube 17 is unlocked again, the middle handle 22 is pushed, the first-stage pushing is finished, the release body and the membrane tube 7 are pushed out of the storage tube shell 13, the storage tube shell 13 is retracted until the marking line 25 reaches the pylome, the lower support 2 is pushed out of the storage tube shell 13, the second-stage pushing is finished, the lower support 2 is left at the duodenal bulb 103, the upper support 1 is pushed out of the storage tube shell 13, and the upper support 1 is left at the pylome 102 to finish the release. Specifically, when the handle is operated, the limit ball 23 is rotated from the 0 gear to the 1 gear, the middle tube 17 is unlocked, the middle handle 22 is slowly pushed until the handle cannot be pushed by resistance, the first-stage pushing is completed, the release body shell 11 and the membrane tube 7 are pushed out of the storage tube shell 13, the storage tube shell 13 is retracted until the marking line 25 reaches the threshold, the limit ball 23 is rotated from the 1 gear to the 2 gear, the middle tube 17 is unlocked again, the middle handle 22 is slowly pushed until the handle cannot be pushed by resistance, the second-stage pushing is completed, the lower support 2 is pushed out of the storage tube shell 13, the lower support 2 is left at the duodenal bulb 103, the limit ball 23 is rotated from the 2 gear to the 3 gear again, the middle tube 17 is unlocked, the middle handle 22 is propped against, the front handle 24 is pulled backwards, the upper support 1 is pushed out of the storage tube shell 13, the upper support 1 is left at the threshold 102, and the release is completed. The membrane tube 7 reaches the upper section of jejunum along with intestinal peristalsis, at the moment, the inner core 12 of the release body is automatically dissolved, and the outer shell 11 of the release body is automatically separated from the membrane tube 7, so that the release process is completed. The conveyor withdraws the human body from the oral cavity, and the built-in sleeve is left in the body, thereby playing a role in isolating food.
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.
Compared with the prior art, the upper bracket is fixed at the pylome, and the lower bracket is fixed at the duodenal bulbar and is connected with the membrane tube. The two brackets cannot move freely and can only move in a small range, and particularly, the upper bracket cannot enter the inside of the pylorus, the lower bracket cannot enter the outside of the pylorus, and the connecting wire is arranged in the middle of the upper bracket, so that the displacement range cannot exceed the range of the connecting wire. The height of the joint of the upper bracket and the lower bracket is 1-8cm, and the upper bracket is positioned outside the pylorus according to different human body structures, the lower bracket is positioned at the duodenal bulbar portion, and the lowest end of the lower bracket can not reach the duodenal bulbar portion, so that the normal function of the nipple is not influenced. The principle of action of the invention is that a membrane tube is implanted in the duodenum and extends to the far end of the alimentary canal, and food is isolated by the membrane tube, so that the metabolic mechanism is changed, and the invention plays a role in treating metabolic diseases such as obesity, diabetes and the like. The stent mainly has the functions of fixing the membrane tube and expanding the membrane tube so that food can enter the implanted membrane tube. The length of the extended membrane tube (sleeve) is 600mm-1600mm, and the membrane tube is a main functional structure. The upper bracket is smaller, so that pressure can not be caused in the stomach, the structure with the lower part smaller and the upper part larger than the lower part of the digestive tract bracket is easy to empty, and food is not easy to stay. The pylons are fixed by the brackets, and the positions of the membrane tubes are not easy to displace in response to the upper and lower positions.
Compared with the patent documents with publication numbers of CN102335052, CN104382671, CN204671331, CN205359721 and the like, the invention discloses a digestive tract stent, which has different functions and structures: in the invention, the shapes of the upper bracket and the lower bracket are different; the connecting line is arc-shaped and needs to conform to the anatomical structure of the pylorus; the number of the connecting wires is generally more than two so as to be firmly connected; the fixing device is used for fixing the pylorus, in particular to an intestinal canal isolation membrane tube, and the product is particularly applied to treating metabolic diseases such as diabetes, obesity and the like. The lower bracket needs to be connected with a section of soft membrane tube to achieve the purpose of treatment.
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 (6)
1. The utility model provides a stomach deflector, includes accomodates shell of pipe (13), release body and pushing component, accomodate shell of pipe (13) and take in the tubulose, accomodate the both ends of shell of pipe (13) and be the opening, accomodate shell of pipe (13) in set up to wait to release in the shell of pipe (7) and alimentary canal support in the folded state, release body set up in accomodate shell of pipe (13) distal end opening part and with one end connection of membrane tube (7), release body is made by the material that can be digested by human intestinal absorption or dissolution; the digestive tract stent has a pre-deployment shape and a post-deployment shape, and is characterized in that the digestive tract stent comprises an upper stent (1), a lower stent (2) and a connecting piece (3); in the shape after being unfolded, the upper bracket (1) is provided with a first opening near the top and a second opening near the bottom of the upper bracket (1), the lower bracket (2) is arranged below the upper bracket (1), the lower bracket (2) is provided with a third opening near the top of the lower bracket and a fourth opening near the bottom of the lower bracket, the upper bracket (1) and the lower bracket (2) are connected through a plurality of connecting pieces (3), the fourth opening of the lower bracket (2) is connected with a membrane tube (7), and the unfolded upper bracket (1) and the unfolded lower bracket (2) can not pass through an unfolded gastric pylorus opening, and the connecting pieces (3) can pass through the gastric pylorus opening or pass through the gastric pylorus opening;
The connecting piece (3) comprises a plurality of connecting wires, the upper ends of the connecting wires are respectively connected with the upper bracket (1), and the lower ends of the connecting wires are respectively connected with the lower bracket (2);
the connecting piece (3) can generate elastic deformation which is compliant with the bending or the reduced outer diameter of the human body pylorus in a natural state at the position corresponding to the stomach pylorus;
the upper end of the connecting wire is fixedly connected with the top of the upper bracket (1) close to the position of the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower bracket (2) close to the position of the third opening.
2. The gastric deflector of claim 1, wherein the connecting wire is coated with an outer membrane.
3. The digestive tract stent of a gastric inducer according to claim 2, characterized in that the upper stent (1) is cone-shaped, inverted cone-shaped, straight-shaped or straw-cap-shaped.
4. A gastrointestinal stent for a gastric inducer according to claim 2, characterized in that the second opening outer diameter of the upper stent (1) is larger than the first opening outer diameter.
5. The digestive tract support of the gastric inducer according to claim 2, wherein the upper end of the connecting wire is fixedly connected with the top of the upper support (1) near the first opening, and the lower end of the connecting wire is fixedly connected with the top of the lower support (2) near the third opening after the connecting wire passes through the mesh in the middle of the upper support (1).
6. A gastric deflector according to any one of claims 1 to 5, characterized in that the receiving envelope (13) is provided with marking lines (25).
Priority Applications (6)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810336514.2A CN108938163B (en) | 2018-04-12 | 2018-04-12 | Gastric inducer and method of releasing same |
| EP18914681.4A EP3777784B1 (en) | 2018-04-12 | 2018-10-24 | Gastric diverter and digestive tract support and release method thereof |
| ES18914681T ES2934842T3 (en) | 2018-04-12 | 2018-10-24 | Gastric bypass and digestive tract support and its method of release |
| PL18914681.4T PL3777784T3 (en) | 2018-04-12 | 2018-10-24 | Gastric diverter and digestive tract support and release method thereof |
| US16/981,322 US11517461B2 (en) | 2018-04-12 | 2018-10-24 | Gastric diverter and digestive tract support and release method thereof |
| PCT/CN2018/111746 WO2019196380A1 (en) | 2018-04-12 | 2018-10-24 | Gastric diverter and digestive tract support and release method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810336514.2A CN108938163B (en) | 2018-04-12 | 2018-04-12 | Gastric inducer and method of releasing same |
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| CN108938163A CN108938163A (en) | 2018-12-07 |
| CN108938163B true CN108938163B (en) | 2023-12-26 |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| EP1804888B1 (en) | 2004-10-15 | 2013-12-25 | Bfkw, Llc | Bariatric device |
| US8529431B2 (en) | 2007-02-14 | 2013-09-10 | Bfkw, Llc | Bariatric device and method |
| US20220079791A1 (en) * | 2019-01-03 | 2022-03-17 | Alexander BUTZ | Gastrointestinal implant and positioning apparatus therefor |
| WO2020154149A1 (en) * | 2019-01-22 | 2020-07-30 | Lean Medical Technologies, Inc. | Obesity treatment device and method |
| EP3946151A4 (en) * | 2019-03-25 | 2022-12-07 | Bfkw, Llc | Intraluminal device and method with anti-migration |
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| CN107308534A (en) * | 2017-06-27 | 2017-11-03 | 杭州糖吉医疗科技有限公司 | Stomach air deflector and its alimentary canal anti-microbial catheter |
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| CN106923944A (en) * | 2017-04-28 | 2017-07-07 | 杭州糖吉医疗科技有限公司 | Enteron aisle isolates membrane tube release |
| CN107126306A (en) * | 2017-06-27 | 2017-09-05 | 杭州糖吉医疗科技有限公司 | Stomach air deflector and its support |
| CN107308534A (en) * | 2017-06-27 | 2017-11-03 | 杭州糖吉医疗科技有限公司 | Stomach air deflector and its alimentary canal anti-microbial catheter |
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