Patent Description:
In recent years, people have paid more attention to diabetes. Diabetes is a common endocrine disease caused by fine dining and ingestion of more food, excessive nutrition intake and less exercising. Specifically, diabetes is a group of metabolic disorders characterized by high blood sugar, due to failure to produce enough insulin or respond to insulin properly or both. Serious long-term complications of diabetes include cardiovascular disease, chronic kidney disease, and damage to the eyes and nerves. Other complications of diabetes such as obesity also pose a great threat to people's health. Among adults over <NUM> years old in China, the prevalence of diabetes is <NUM>%; that is, in China <NUM> million people have diabetes. Treatment of diabetes involves maintaining a healthy diet, regular physical exercise, and medication treatment, which requires persistence. If patients stop their diet, they will likely regain the weight or have rebound weight gain. Furthermore, constant medication treatment or insulin injection remain a financial burden and inconvenience in daily life.

Gastric bypass surgery also has tremendous effects in improving the symptoms of type <NUM> diabetes and obesity. In <NUM>, the International Diabetes Federation suggests that bariatric surgery (including gastric bypass) should be considered an appropriate treatment for severely obese patients with type <NUM> diabetes. However, as a surgical procedure, gastric bypass may leave surgical wound in human bodies, and involve the potential for complications which increase risk and mortality, such as bowel obstruction, anastomotic leakage, pulmonary embolism, deep vein thrombosis, portal vein thrombosis, and respiratory failure.

Some patients treat diabetes by inserting a kind of intestinal bypass liner. The intestinal bypass liner is complicated in structure and operation by having multiple lines to be pulled at the same time and it also requires professional guidance before operation. A user not familiar with the operation of the intestinal bypass liner may operate the intestinal bypass liner wrongly and discomfort the patients. Moreover, due to the problems of high manufacturing cost and technical limitations of the intestinal bypass liner, it is difficult to promote and apply the intestinal bypass liner in a wide range of the country. Therefore, providing a method for diabetes treatment without causing discomfort, or providing a device having a simple structure and a low cost and easy to be operated for diabetes treatment has become an important issue to be solved.

Devices and delivery systems for implanting in the gastrointestinal tract are disclosed e.g. in <CIT>, which discloses the features of the preamble of claim <NUM>, and <CIT>. Devices with intestinal barrier sleeve release systems having a dissolvable release body are disclosed in <CIT>, <CIT>, and <CIT>.

According to the present invention, an intestinal barrier sleeve release system according to claim <NUM> is provided. Preferred embodiments are further defined in the dependent claims.

In response to the above-referenced technical inadequacies, the present disclosure provides an intestinal barrier sleeve release system. The intestinal barrier sleeve release system guided by a gastroscope enters the duodenum and/or an upper part of the pylorus from the mouth through a guidewire, and separates the intestinal tissues from the food in the gastrointestinal tract, so as to improve insulin secretion and treat diabetes in a better way without hurting human body.

In one aspect, the present disclosure provides an intestinal barrier sleeve release system including a tubular housing having a first opening at one end and a second opening at the other end. A folded tubular sleeve to be released is disposed in the housing. The intestinal barrier sleeve release system further includes a release body and a push assembly. The release body is disposed at the first opening, connected to one end of the tubular sleeve, and made of a material that is able to be dissolved and absorbed in human intestines. The push assembly includes an inner sheath, a middle sheath and an outer sheath sequentially set and able to move relative to each other. The inner sheath is partially located in the housing and connected to the release body, the middle sheath has a piston stopper in the housing fixedly sleeved on an end, and the outer sheath is located outside the housing and has an end fixedly connected to the second opening. The inner sheath and the middle sheath are operated to move axially, the release body is disengaged from the housing, and the tubular sleeve moves out of the housing and is released at a specified position of the human intestines.

The release body includes an internal core and a casing. The internal core has a body portion and a tubular sleeve connecting portion formed by extending the body portion. The tubular sleeve connecting portion is fixedly connected to the one end of the tubular sleeve. The casing covers the body portion and is connected to the first opening.

Preferably, an end of the inner sheath sequentially passes through the tubular sleeve connecting portion, the body portion and the casing of the internal core.

Preferably, a damper sheath is sleeved on a portion of the inner sheath passing out of the internal core.

Preferably, a surface of the body portion of the internal core and a surface of the casing facing a release direction of the tubular sleeve are round smooth surfaces.

Preferably, the body portion has an outer contour in a spherical or hemispherical shape, and the casing has an outer contour matches the outer contour of the body portion in shape, and covers the body portion outside.

Preferably, the body portion has an outer contour in a hemispherical shape, the tubular sleeve connecting portion is connected to a planar portion of the body portion, the casing is in a hemisphere shape and covers the body portion outside a hemispherical surface thereof, and an annular platform is formed on the periphery of an end surface of the hemispherical casing, and is abutted against the second opening of the housing.

Preferably, the internal core is physically connected to the casing.

Preferably, the other end of the tubular sleeve is fixedly connected to a stent, and the stent is an elastic memory alloy braided stent in a tubular mesh form.

Preferably, the middle sheath has a first extension end extending from the other end of the outer sheath, the first extension end is connected to a first handle, the first handle is provided with a Luer taper communicating the outside with the inside of the middle sheath, the inner sheath has a second extension end extending from the first extension end, and the second extension end is connected to a second handle.

In comparison with conventional technology, the intestinal barrier sleeve release system of the present disclosure has a simple structure, relatively few parts and low manufacturing cost. Implanting the intestinal barrier sleeve release system in a human body will not leave wounds in intestines, and is considered a low risk surgery operated by simple pushes, such that patients can suffer less pain and recover quickly after surgery. Unlike operating conventional equipment which is complicated in structure and has multiple lines to be pulled, people after simple training can operate the intestinal barrier sleeve release system of the present disclosure correctly and effectively. Moreover, the intestinal barrier sleeve release system of the present disclosure can be used to assist the extension of a soft catheter and the observation of gastrointestinal peristalsis. After implantation, the release body gradually disintegrates, is decomposed by digestive juices and is absorbed in the human body, and barium sulfate is excreted through the intestines, such that the intestinal barrier sleeve release system is safe to the human body. Therefore, after implanting the intestinal barrier sleeve of the present disclosure, the symptoms of type <NUM> diabetes and obesity can be greatly improved. Since patients do not need to have a diet anymore, they can have a better quality of your life.

These and other aspects of the present disclosure will become apparent from the following description of the embodiment taken in conjunction with the following drawings and their captions.

The present disclosure will become more fully understood from the following detailed description and accompanying drawings.

Referring to <FIG> and <FIG>, an intestinal barrier sleeve release system is provided in an embodiment of the present disclosure. The intestinal barrier sleeve release system includes a housing <NUM>, a release body <NUM> and a push assembly. The housing <NUM> is tubular and has a first opening <NUM> at one end and a second opening <NUM> at the other end. A folded tubular sleeve <NUM> to be released disposed in the housing <NUM>. The release body <NUM> is disposed at the first opening <NUM>, connected to one end of the tubular sleeve <NUM>, and made of a material that is able to be dissolved and absorbed in human intestines. The push assembly includes an inner sheath <NUM>, a middle sheath <NUM> and an outer sheath <NUM> sequentially set and able to move relative to each other. The inner sheath <NUM> is partially located in the housing <NUM> and connected to the release body <NUM>. An end of the middle sheath <NUM> extends into the housing <NUM> through the second opening <NUM> and has a piston stopper in the housing <NUM> fixedly sleeved thereon. The outer sheath <NUM> is located outside the housing <NUM> and has an end fixedly connected to the second opening <NUM>. The inner sheath <NUM> moves axially toward an operator to disengage the release body <NUM> from the housing <NUM>. The inner sheath <NUM> and the middle sheath <NUM> drive the tubular sleeve <NUM> to move out of the housing <NUM> and to release at a specified position of the human intestines. The movement of the inner sheath <NUM> drives the release body <NUM> to move, and drives the tubular sleeve <NUM> to release. The middle sheath <NUM> move axially to drive the piston stopper <NUM> to push against the tubular sleeve <NUM> (i.e. pushing against an end of the tubular sleeve <NUM> which is not connected to the release body <NUM>) so that the tubular sleeve <NUM> is pushed out of the housing <NUM>.

Further, referring to <FIG>, a protrusion is provided outside the second opening <NUM> of the housing <NUM> and has a nut <NUM> screwed thereon. The outer sheath <NUM> passes through the nut <NUM> and is fixedly connected to the second opening <NUM> of the housing <NUM>. Specifically, the outer sheath <NUM> can be fixedly connected to the second opening <NUM> by sticking, thermal shrinkage, or other manners.

In this embodiment, the housing <NUM> and each part of the push assembly is made of one or more composite materials of polyurethane, polyethylene, and fluoropolymer. Aside from good support performance, pushability, toughness and a smooth surface to be smoothly pushed via an endoscope or in the tracts of the human body, also these materials is not easy to be bent and can be well controlled.

Specifically, in the use of the intestinal barrier sleeve release system of the present disclosure, a guidewire is passed through the inner sheath <NUM>, the operator passes the entire system through the mouth, in cooperation with, the system is guided by the guidewire in cooperation with the gastroscope to the duodenum and/or an upper part of the pylorus. The guidewire and the push assembly guide and support the movement of the inner sheath <NUM> in the esophagus and gastrointestinal tract, so that the casing <NUM> and tubular sleeve <NUM> of the intestinal barrier sleeve release system can successfully reach the specified position. Then, the middle sheath <NUM> and the inner sheath <NUM> in the push assembly are operated to release the tubular sleeve <NUM> in the casing <NUM> into the gastrointestinal tract, and the inner sheath <NUM> is operated to move the release body <NUM> to unfold the folded tubular sleeve <NUM>. After the release body <NUM> made of a material that can be dissolved and absorbed in the human intestinal tract enters the intestines, it can be dissolved or decomposed in a short period of time by digestive juices or water, and then be dissolved and absorbed in the intestines, thereby completing the release of the tubular sleeve <NUM>. In this way, a thin-film guide tube forms on the intestinal tissues to prevent and slow down nutrient absorption in the intestinal tract, and regulate the secretion of digestive enzymes, thereby regulating blood sugar and lipid levels and body weight, and avoiding the occurrence of diabetes. The release body <NUM> is made of a material which meets a biological safety requirement, can be dissolved or decomposed in the human body, and has no toxicity or side effects for the human body. The material may be, for example, one or more compounds of an edible gelling agent, a soy protein powder, starch, a polysaccharide compound, glycerin, branched or amylopectin, and the like. During formulation, the one or more compounds are added, mixed with water and a fat-soluble substance, and then solidified in a corresponding mold, to form a hard solid structure. Moreover, the release body <NUM> can also be made of a material which can be dissolved but not absorbed in the human body, and completely eliminated from the human body, without toxicity or side effect.

Referring to <FIG>, the release body <NUM> includes an internal core <NUM> and a casing <NUM>. The internal core <NUM> has a body portion <NUM> and a tubular sleeve connecting portion <NUM> connected to the one end of the tubular sleeve <NUM>. The casing <NUM> covers the body portion <NUM> outside, is connected to the first opening <NUM> and is easily broken under force.

Preferably, referring to <FIG>, a surface of the body portion <NUM> of the internal core <NUM> and a surface of the casing <NUM> facing a release direction of the tubular sleeve <NUM> are round smooth surfaces, which facilitates the movement of the release body <NUM> in the human intestinal tract.

Specifically, referring to <FIG>, the body portion <NUM> has an outer contour in a spherical or hemispherical shape. The casing <NUM> has an outer contour matches the outer contour of the body portion <NUM> in shape, and covers the body portion outside. In this embodiment, the body portion <NUM> has the outer contour in a hemispherical shape, and the casing <NUM> has the outer contour in a hemispherical shape. In addition, the body portion <NUM> and the casing <NUM> can be approximately shaped like a sphere or hemisphere.

Preferably, referring to <FIG>, the body portion <NUM> has the outer contour in a hemispherical shape, the tubular sleeve connecting portion <NUM> is connected to a planar portion of the body portion <NUM>, the casing <NUM> is in a hemisphere shape and covers the body portion <NUM> outside a hemispherical surface thereof. An annular platform <NUM> is formed on the periphery of an end surface of the hemispherical casing <NUM>, and is abutted against the second opening <NUM> of the housing <NUM>.

Referring to <FIG>, based on the above, the internal core <NUM> is physically connected to the casing <NUM> by, for example, screwing or engaging as shown. Specifically, <FIG> shows the screwed inner core <NUM> and casing <NUM>. The internal core <NUM> and the casing <NUM> both include a portion in an approximately spherical shape and a portion in a cylindrical shape, and have threads engaged with each other on the portions in a cylindrical shape of the internal core <NUM> and the casing <NUM>. <FIG> shows the engaged inner core <NUM> and casing <NUM>. An outer surface of the internal core <NUM> and an inner wall of the casing <NUM> are respectively provided with fasteners which can be engaged to each other. It should be noted that the connection manner between the internal core <NUM> and the casing <NUM> is not limited to screwing or engaging, and can be a taper fit or other connection manners. For example, the casing <NUM> and the internal core <NUM> are taper-fitted to each other. Other similar structures are not described in detail herein.

Preferably, referring to <FIG>, an end of the inner sheath <NUM> sequentially passes through the tubular sleeve connecting portion <NUM> and the body portion <NUM> of the internal core <NUM>, and the casing <NUM>, and extends out of the first opening <NUM> to allow an endoscope to inspect the intestinal tract. In this embodiment, the inner sheath <NUM> forms a tight fit or an interference fit with the tubular sleeve connecting portion <NUM> and the body portion <NUM> of the internal core <NUM>, and the housing <NUM>, such that the inner sheath <NUM> can drive the release body <NUM> to move toward the release direction of the tubular sleeve <NUM> and the tubular sleeve <NUM> to be unfolded and to extend out of the housing <NUM>. The tubular sleeve connecting portion <NUM>, the body portion <NUM> and the casing <NUM> can be connected to the inner sheath <NUM> in different manners.

Preferably, referring to <FIG>, a damper sheath <NUM> is sleeved on a portion of the inner sheath <NUM> passing out of the internal core <NUM>. In this embodiment, a tight fit is formed between the inner sheath <NUM> and the internal core <NUM> via the damper sheath <NUM>. The damper sheath <NUM> is used to increase sliding friction between the release body <NUM> and the inner sheath <NUM>, thereby enhancing the capability of the inner sheath <NUM> to drive the release body <NUM> to move.

In this embodiment, the damper sheath <NUM> can be made from one or more elastic materials of polyurethane, silicone, and TPE, with a surface subjected to physical or chemical processing to increase friction. Accordingly, before the tubular sleeve <NUM> is released, the damper sheath <NUM> maintains a relatively static state between the release body <NUM> and the inner sheath <NUM>.

Preferably, referring to <FIG>, the other end of the tubular sleeve <NUM> is fixedly connected to a stent <NUM>, and the stent is an elastic memory alloy braided stent in a tubular mesh form. Specifically, the stent <NUM> can be made of a nickel-titanium alloy, stainless steel, other elastic metal or other qualified memory alloys, meeting a biocompatibility requirement and suitable for long-term implantation in the human body. The stent <NUM> is regularly arranged in the shape of a rhombus, hexagon, or honeycomb, and placed in the duodenal bulb. The stent is elastic and can vary in shape with the peristalsis of the intestinal tract. Also, it has a certain supporting force and can be fixed in the duodenal bulb.

Specifically, during the operation of the middle sheath <NUM>, the middle sheath <NUM> drives the piston stopper <NUM> to push the stent <NUM> and the tubular sleeve <NUM> outward from the housing <NUM> while the operator has to observe the stent <NUM> in the housing <NUM> via the endoscope. When the front end of the stent <NUM> is about to be out of the housing <NUM>, the operation of the middle sheath <NUM> should be stopped immediately. At the same time, the operator has to adjust the position of the housing <NUM> of the intestinal barrier sleeve release system so that the stent <NUM> can be fixed in the duodenal bulb when leaving the housing <NUM>.

Specifically, based on the above, the structure used to operate the movement of the middle sheath <NUM> and the inner sheath <NUM> includes a first extension end <NUM> and a first handle <NUM>, a Luer taper <NUM>, a second extension end <NUM> and a second handle <NUM>. The middle sheath <NUM> has the first extension end <NUM> extending out of the outer sheath <NUM>, the first extension end <NUM> is connected to the first handle <NUM>, the first handle <NUM> is provided with a Luer taper <NUM> communicating the outside with the inside of the middle sheath <NUM>, the inner sheath <NUM> has the second extension end <NUM> extending from the first extension end <NUM>, and the second extension end <NUM> is connected to the second handle <NUM>.

Specifically, in the process of operating the middle sheath <NUM> and the inner sheath <NUM> to release the tubular sleeve <NUM>, the operator can add a certain amount of water or saline through the Luer taper <NUM>. As the water or saline enters the tubular sleeve <NUM> through a gap between the middle sheath <NUM> and the inner sheath <NUM>, the release of the tubular sleeve <NUM> in the duodenum and the dissolution or decomposition of the release body <NUM> can be accelerated. When the tubular sleeve <NUM> is released, the tubular sleeve <NUM> and the release body <NUM> move from the duodenum towards the jejunum with the peristalsis of the intestinal tract for about <NUM> to <NUM> minutes. At the same time, as the saline flows towards the tubular sleeve <NUM> along the gap between the inner sheath <NUM> and the middle sheath <NUM>, the movement of the tubular sleeve <NUM> and the release body <NUM> towards the jejunum and the release of the tubular sleeve <NUM> are also accelerated. The tubular sleeve <NUM> may contain a developing material, such as barium sulfate, bismuth carbonate, and tungsten, which can be developed under X rays. The release body <NUM> may also contain a developing material so as to provide its position under X rays, thereby facilitating the operation.

The intestinal barrier sleeve release system of the present disclosure can be operated as follows. Firstly, the inner sheath <NUM> is pulled by and towards the operator, such that when the first opening <NUM> of the housing <NUM> is pressed against the casing <NUM>, the annular platform <NUM> of the casing <NUM> is disconnected to separate the release body <NUM> from the housing <NUM>. Then, the inner sheath <NUM> is operated to move the release body <NUM> away from the operator (i.e. into the body of a patient), such that one end of the tubular sleeve <NUM> extends out of the housing <NUM> and drives the tubular sleeve <NUM> to be unfolded. In this case, the middle sheath <NUM> is then operated to drive the piston stopper <NUM> to move. The piston stopper <NUM> pushes the stent <NUM> on the other end of the tubular sleeve <NUM> in the housing <NUM> to push the whole tubular sleeve <NUM> out of the housing <NUM>. It should be noted that when the tubular sleeve <NUM> is completely unfolded and the piston stopper <NUM> pushes the stent <NUM> to move to the first opening <NUM> of the housing <NUM> (when the tubular sleeve <NUM> is about to be completely released), the stent <NUM> has to arrive at a specified release position in the intestinal tract (an appropriate position near the duodenum of the stomach pylorus and/or the upper portion of the stomach pylorus in the stomach of the body). Then, the second handle <NUM> is pushed in a direction away from the operator so that the stent <NUM> is completely detached from the housing <NUM> and fixed in the duodenal bulb. The stent is elastic and can vary in shape with the peristalsis of the intestinal tract. Also, it has a certain supporting force and can be fixed in the duodenal bulb. The unfolded tubular sleeve <NUM> may be placed in the digestive tract for <NUM> to <NUM> months, and the duration can be adjusted according to disease conditions or actual conditions.

In this embodiment, there is still another way of operation described as follows. When the middle sheath <NUM> and the inner sheath <NUM> are simultaneously operated to move the piston stopper <NUM> to push one end of the tubular sleeve <NUM> in the housing <NUM>, the inner sheath <NUM> moves to drive the release body <NUM> to move, and the release body <NUM> drives the stent <NUM> on the other end of the tubular sleeve <NUM>. In this way, the tubular sleeve <NUM> is unfolded and extends out of the housing <NUM>. Finally, the whole tubular sleeve <NUM> is pushed out of the housing <NUM> at a specified release position in the intestinal tract.

Accordingly, the tubular sleeve <NUM> may be made from one or more composite materials of polyurethane, polyethylene, fluoropolymer, and silicone, which are soft and elastic and have a smooth surface such that food residues are less likely to be left at the inner wall of the tubular sleeve <NUM>. The material thereof meets a biocompatibility requirement, and does not cause an allergy or other adverse effects to the human body during long-term implantation.

The embodiments were chosen and described in order to explain the principles of the disclosure and their practical application so as to enable others skilled in the art to utilize the disclosure and various embodiments and with various modifications as are suited to the particular use contemplated. Alternative embodiments will become apparent to those skilled in the art.

Claim 1:
An intestinal barrier sleeve release system, including a tubular housing (<NUM>) having a first opening (<NUM>) at one end and a second opening (<NUM>) at the other end, a folded tubular sleeve (<NUM>) to be released disposed in the housing (<NUM>), the intestinal barrier sleeve release system comprising:
a release body (<NUM>) disposed at the first opening (<NUM>), connected to one end of the tubular sleeve (<NUM>), and wherein the release body (<NUM>) includes an internal core (<NUM>) having a body portion (<NUM>) and a tubular sleeve connecting portion (<NUM>) formed by extending the body portion (<NUM>), the tubular sleeve connecting portion (<NUM>) fixedly connected to the one end of the tubular sleeve (<NUM>);
a push assembly including an inner sheath (<NUM>), a middle sheath (<NUM>) and an outer sheath (<NUM>) sequentially set and able to move relative to each other, the inner sheath (<NUM>) partially located in the housing (<NUM>) and connected to the release body (<NUM>), an end of the middle sheath (<NUM>) extending into the housing (<NUM>) through the second opening (<NUM>) and having a piston stopper in the housing (<NUM>) fixedly sleeved on the end of the middle sheath (<NUM>), and the outer sheath (<NUM>) located outside the housing (<NUM>) and having an end fixedly connected to the second opening (<NUM>);
wherein the inner sheath (<NUM>) and the middle sheath (<NUM>) are operable to move axially, the release body (<NUM>) is disengagable from the housing (<NUM>), and the tubular sleeve (<NUM>) is configured to move out of the housing (<NUM>) and is configured to be released at a specified position of the human intestines;
characterized in that the release body (<NUM>) is made of a material that is able to be dissolved and absorbed in human intestines; and
wherein the release body (<NUM>) includes a casing (<NUM>) covering the body portion (<NUM>) and connected to the first opening (<NUM>).