Multi-segment gastric bypass stent and release method thereof

Abstract

The invention discloses a multi-segment gastric bypass stent, which comprises a support frame main body and a separator arranged outside the support frame main body in a wrapping manner, the support frame main body sequentially comprises a first segment, a second segment, a third segment and a fourth segment from top to bottom, and the first segment is used for being matched, abutted and matched with a gastric antrum part in a limiting manner; the second section is used for abutting against the duodenum ball part in a limiting fit mode. The third section is provided with a framework and is arranged in the duodenum; the diameter of the fourth section is larger than that of the third section, and the fourth section is matched with the peristalsis of the duodenum to stretch the support frame main body towards the extension direction of the support frame main body; the third section comprises a non-clinging section matched with the hepatopancreatic ampulla, and the non-clinging section is used for discharging bile and pancreatic juice from the hepatopancreatic ampulla; and the separator is used for separating the chyme from the duodenum. The multi-section stomach bypass support is reasonable in structure, can prevent the stomach bypass support from blocking the hepatopancreatic ampulla, guarantees normal work of the hepatopancreatic ampulla, and avoids the occurrence of diseases such as pancreatitis.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a multi-segment gastric bypass stent and a method for releasing the same. Background Art

[0002] Obese patients often suffer from diabetes. The laparoscopic gastric bypass surgery for weight loss has been proven to improve the condition of type 2 diabetes in obese patients after the operation. Although this surgery is minimally invasive, simple, fast, with a short operation time and quick recovery. Generally, patients no longer need to take hypoglycemic drugs after the operation and can maintain normal blood glucose levels for a long time. Compared with the long-term treatment with hypoglycemic drugs, the relative cost is not high, which greatly reduces the economic burden on patients and also reduces the social burden on the country. However, the surgery changes the digestive tract structure, affects the digestive tract function, and there are also many complications. Many patients are also afraid of the surgery, which limits its clinical application.

[0003] Therefore, researchers have developed a gastric bypass method with less trauma, lower cost and more convenient use - endoscopic gastric bypass. Endoscopic gastric bypass is to implant a duodenal cannula to divert the gastric effluent from the gastric pylorus to the jejunum, replacing the laparoscopic gastric bypass surgery, and avoiding the direct digestion, absorption and metabolism of the gastric effluent in the duodenum, for the treatment of obesity and diabetes. Although some animal experiments and clinical studies have been carried out in a few countries such as the United States and Brazil, and the definite curative effect has also been proved, there are still many problems in the designed products.

[0004] The outer surface of the gastric bypass stent in the prior art is covered with an isolation membrane, and the isolation membrane fits tightly with the inner wall of the duodenum, which will cause the obstruction of the hepatopancreatic ampulla, resulting in the inability of bile and pancreatic juice to flow into the duodenum normally, triggering symptoms such as pancreatitis and affecting the health of patients. Summary of the Invention

[0005] The purpose of the present invention is to overcome the defects existing in the prior art, and provide a multi-segment gastric bypass stent and a method for releasing the same, which can avoid the obstruction of the hepatopancreatic ampulla by the gastric bypass stent, ensure the normal operation of the liver and pancreas, and avoid the occurrence of diseases such as pancreatitis.

[0006] To achieve the above technical effects, the technical solution of the present invention is as follows: A multi-segment gastric bypass stent includes a support frame main body and a spacer disposed outside the support frame main body. The support frame main body sequentially includes a first segment, a second segment, a third segment, and a fourth segment from top to bottom. The first segment is used for mating and abutting with the gastric antrum for limit cooperation; the second segment is used for abutting and limiting cooperation with the duodenal bulb; the third segment is provided with a framework and is disposed in the duodenum; the diameter of the fourth segment is larger than that of the third segment, and the fourth segment cooperates with the peristalsis of the duodenum to stretch the support frame main body in its extending direction; the third segment includes a non-abutting segment that cooperates with the hepatopancreatic ampulla, and the non-abutting segment is used for the hepatopancreatic ampulla to discharge bile and pancreatic juice; the spacer is used to isolate chyme from the duodenum.

[0007] According to an embodiment of the present invention, the third segment includes a plurality of braided mesh units and connecting units, and adjacent two of the braided mesh units are connected by the connecting units.

[0008] According to an embodiment of the present invention, the framework includes a plurality of intersecting titanium alloy units, and the density of the titanium alloy units of the connecting unit is less than the density of the titanium alloy units of the braided mesh unit.

[0009] According to an embodiment of the present invention, the support frame main body is deformable, and the support frame main body includes two working states. The first working state: the expanded and released state in the patient's body; the second working state: the contracted state during transportation and installation.

[0010] According to an embodiment of the present invention, in the second working state, the connecting unit is in a contracted state both in its radial direction and axial direction, and adjacent two of the braided mesh units are disposed adjacent to each other.

[0011] According to an embodiment of the present invention, the spacer is a transparent silica gel film.

[0012] According to an embodiment of the present invention, it further includes a release assembly, and the release assembly is used to switch the support frame main body from the second working state to the first working state.

[0013] According to an embodiment of the present invention, it further includes an inner contraction member for limiting the support frame main body in the second working state. The inner contraction member includes catgut for tightly contracting the support frame main body, and the catgut winding end is located at the end of the fourth segment.

[0014] According to an embodiment of the present invention, the release assembly includes a guiding assembly disposed within the main body of the support frame. The guiding assembly includes a high-frequency electrotome disposed within the main body of the support frame. The high-frequency electrotome is used to cut off the thread taking-up of the catgut suture and release the main body of the support frame. An airbag is disposed outside the high-frequency electrotome. The expansion direction of the airbag is radially arranged. In the second working state, the airbag is in contact with the main body of the support frame. In the first working state, the airbag is away from the main body of the support frame, facilitating the extraction of the guiding assembly from the main body of the support frame. The high-frequency electrotome is provided with an endoscope camera.

[0015] The present invention also provides a method for releasing a multi-stage gastric bypass stent. Using the multi-stage gastric bypass stent described above, the method includes the following steps: S1. The catgut suture contracts the main body of the support frame into the second working state. The high-frequency electrotome is disposed within the main body of the support frame. The cutting head of the high-frequency electrotome is in contact with the thread taking-up end of the catgut suture. The airbag is inflated, and the guiding assembly is relatively fixed to the main body of the support frame. S2. The multi-segment gastric bypass stent is inserted into the duodenum of the patient, and the endoscope camera observes whether the multi-segment gastric bypass stent is placed in place. S3. When the multi-segment gastric bypass stent reaches the target position, the high-frequency electrotome is powered on to cut off the catgut suture, and the main body of the support frame is released and expanded. The non-adjacent section is adjacent to the hepatopancreatic ampulla. S4. The guiding assembly can be withdrawn from the main body of the support frame.

[0016] The advantages and beneficial effects of the present invention are as follows: The multi-segment gastric bypass stent of the present invention has a reasonable structure. By providing a non-adjacent section in the third segment, the non-adjacent section cooperates with the hepatopancreatic ampulla to facilitate the smooth discharge of bile and pancreatic juice into the duodenum, avoiding the reflux of bile and pancreatic juice and causing health problems for the patient. When the gastric bypass stent is installed, it is contracted by the catgut suture so as to enter the duodenum through the patient's esophagus, etc. The movement of the isolation stent is determined to be in place through the endoscope camera. The catgut suture is cut off by using the high-frequency electrotome, and the gastric bypass stent automatically returns to the first working state. Subsequently, the guiding assembly is separated from the main body of the support frame and withdrawn, achieving the purpose of simple implantation, reliable fixation, no interference with the outflow of chyme, and good mucosal isolation effect. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Figure 1 is a schematic structural view of the multi-segment gastric bypass stent of the present invention; Figure 2 is a schematic structural view of the main body of the support frame; Figure 3 is a schematic structural view of the first segment; Figure 4 is a schematic view of the first working state of the multi-segment gastric bypass stent in the patient's stomach; Figure 5 is a schematic view of the second working state of the multi-segment gastric bypass stent; Figure 6 is Figure 5 the explosion schematic diagram of In the figure: 1. The main body of the support frame; 11. The first section; 12. The second section; 13. The third section; 14. The fourth section; 2. The isolation member; 3. The non-contact section; 41. The braided mesh unit; 42. The connection unit; 5. The titanium alloy unit; 6. The catgut; 7. The high-frequency electrotome; 8. The airbag; 9. The endoscope camera. Specific embodiments

[0018] The following combines the accompanying drawings and embodiments to further describe the specific embodiments of the present invention. The following embodiments are only used to more clearly illustrate the technical solutions of the present invention and cannot be used to limit the protection scope of the present invention.

[0019] In the description of the present invention, it should be understood that the orientation or positional relationship indicated by the terms "upper", "lower", "front", "rear", "left", "right", "horizontal", "vertical", "top", "outer", etc. is based on the orientation or positional relationship shown in the accompanying drawings, and is only for the convenience of describing the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation of the present invention. In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance. Embodiment

[0020] As Figures 1-6 shown, the multi-segment gastric bypass stent of the embodiment includes the main body 1 of the support frame and the isolation member 2 coated outside the main body 1 of the support frame. The main body 1 of the support frame successively includes the first section 11, the second section 12, the third section 13, and the fourth section 14 from top to bottom. The first section 11 is used for being in abutting and limiting cooperation with the gastric antrum; the second section 12 is used for being in abutting and limiting cooperation with the duodenal bulb; the third section 13 is provided with a framework and is arranged in the duodenum; the diameter of the fourth section 14 is larger than that of the third section 13, and the fourth section 14 cooperates with the peristalsis of the duodenum to stretch the main body 1 of the support frame in its extending direction; the third section 13 includes the non-contact section 3 that cooperates with the hepatopancreatic ampulla, and the non-contact section 3 is used for discharging bile and pancreatic juice from the hepatopancreatic ampulla; the isolation member 2 is used for isolating food from the duodenum.

[0021] With such a design, the first section 11 is positioned in limit with the pyloric antrum of the patient and cannot move downward; the second section 12 is positioned in limit with the duodenal bulb. Since the diameter of the duodenal bulb is larger than that of the duodenum, the second section 12 is positioned in the duodenal bulb, which can play a role in fixing the position of the main body 1 of the support frame to prevent the main body 1 of the support frame from rising or falling; the third section 13 can support the separator 2 between the second section 12 and the fourth section 14 to avoid phenomena such as the separator 2 knotting, bending at 90 degrees, or being blocked in the duodenum; the chyme in the stomach reaches the large intestine through the duodenum. Since the chyme is separated from the duodenum by the separator 2, nutrients, calories, etc. in the chyme cannot be absorbed by the duodenum, thereby achieving the purpose of the patient losing weight; the design of the non-adjacent section 3 can ensure the cooperation between the separator 2 and the hepatopancreatic ampulla space, and bile and pancreatic juice can flow into the duodenum to avoid additional health problems caused by the blockage of bile and pancreatic juice to the patient.

[0022] According to an embodiment of the present invention, the third section 13 includes a plurality of braided mesh units 41 and connection units 42, and adjacent two of the braided mesh units 41 are connected by the connection units 42.

[0023] With such a design, the third section 13 can be compressed to facilitate the placement of the main body 1 of the support frame in the patient's body.

[0024] According to an embodiment of the present invention, the skeleton includes a plurality of intersecting titanium alloy units 5, and the density of the titanium alloy units 5 of the connection unit 42 is less than the density of the titanium alloy units 5 of the braided mesh unit 41.

[0025] With such a design, the number of titanium alloy units 5 of the connection unit 42 is small, but the connection between adjacent two braided mesh units 41 is ensured. Compared with the expansibility of the braided mesh unit 41, the connection unit 42 exerts less pressure on the duodenum, avoiding the duodenum being constantly squeezed throughout.

[0026] According to an embodiment of the present invention, the main body 1 of the support frame is deformable, and the main body 1 of the support frame includes two working states. The first working state: the expanded and released state in the patient's body; the second working state: the contracted state during transportation and installation.

[0027] With such a design, it is ensured that the main body 1 of the support frame can be smoothly placed in the patient's body.

[0028] According to an embodiment of the present invention, in the second working state, the connection unit 42 is in a contracted state both in its radial direction and axial direction, and adjacent two of the braided mesh units 41 are closely arranged.

[0029] According to an embodiment of the present invention, the separator 2 is a transparent silica gel film.

[0030] This design makes it easier for the subsequent endoscope camera 9 to observe whether the support frame body 1 is placed in place.

[0031] According to one embodiment of the present invention, a release assembly is further included, and the release assembly is used to switch the support frame body 1 from the second working state to the first working state.

[0032] According to one embodiment of the present invention, it also includes an internal retractable component for limiting the support frame body 1 to the second working state, and the internal retractable component includes a catgut wire 6 for shrinking and tightening the support frame body 1, and the catgut wire 6 is collected at the end of the fourth section 14.

[0033] With such a design, the catgut wire 6 can be wound to shrink and tighten the support frame body 1, and the wound titanium alloy unit can be staggered with the titanium alloy unit connected to the isolation piece 2, to ensure that the support frame body 1 can shrink smoothly, and the closing is located at the end of the fourth section 14. Subsequently, the catgut wire 6 only needs to be cut with a high-frequency electric knife 7, and the support frame body 1 can expand and recover.

[0034] According to one embodiment of the present invention, the release component includes a guide component inserted into the support frame body 1, and the guide component includes a high-frequency electric knife 7 inserted into the support frame body 1, and the high-frequency electric knife 7 is used to cut off the wire of the catgut 6 to release the support frame body 1; an airbag 8 is arranged outside the high-frequency electric knife 7, and the expansion direction of the airbag 8 is radially arranged. In the second working state, the airbag 8 is arranged in contact with the support frame body 1. In the first working state, the airbag 8 is far away from the support frame body 1, so that the guide component is easy to be pulled out from the support frame body 1; the high-frequency electric knife 7 is provided with an endoscopic camera 9.

[0035] The present invention also provides a method for releasing a multi-stage gastric bypass stent, comprising the following steps: S1, the catgut 6 contracts the support frame body 1 to a second working state, the high-frequency electric knife 7 is inserted into the support frame body 1, the blade head of the high-frequency electric knife 7 is fitted with the retracted end of the catgut 6, the airbag 8 is inflated, and the guide component is relatively fixed to the support frame body 1; S2, the multi-segment gastric bypass stent is delivered into the patient's duodenum, and the endoscopic camera 9 observes whether the multi-segment gastric bypass stent is placed in place; S3, when the multi-segment gastric bypass stent reaches the target position, the high-frequency electric knife 7 is energized to cut off the catgut 6, the support frame body 1 is released and expanded, and the non-tight segment 3 is adjacent to the hepatopancreatic ampulla; S4, the guide component can be withdrawn from the support frame body 1.

[0036] When patients need to retrieve multi-segment gastric bypass stents: At the end of the first section, there are a storage wire and a wire hole 111 provided for shrinking the first section 11. By using a medical tool such as a foreign body forceps to hook the wire hole 111, pulling the wire hole 111 can shrink the first section 11 through the storage wire and pull out the support frame body 1 from the duodenum. The diameters of the second section 12 and the fourth section 14 are slightly larger than the diameter of the duodenum. Under the action of external force, it does not affect the normal pulling out of the isolation stent.

[0037] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the technical principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A multi-segment gastric bypass stent, characterized in that, The invention comprises a support frame body (1) and an isolating member (2) which is arranged outside the support frame body (1), wherein the support frame body (1) comprises, from top to bottom, a first section (11), a second section (12), a third section (13) and a fourth section (14), wherein the first section (11) is used to abut and limit with the gastric antrum; the second section (12) is used to abut and limit with the duodenal bulb; the third section (13) is provided with a skeleton and is arranged in the duodenum; the diameter of the fourth section (14) is greater than the diameter of the third section (13), and the fourth section (14) cooperates with the peristalsis of the duodenum to stretch the support frame body (1) in its extension direction; The third section (13) comprises a non-close-fitting section (3) matched with the hepatopancreatic ampulla, and the non-close-fitting section (3) is used for the hepatopancreatic ampulla to discharge bile and pancreatic juice; The isolation piece (2) is used to isolate the chyme from the duodenum.

2. The multi-segment gastric bypass stent according to claim 1, wherein, The third section (13) comprises a plurality of woven mesh units (41) and a connecting unit (42), and two adjacent woven mesh units (41) are connected via the connecting unit (42).

3. The multi-segment gastric bypass stent according to claim 2, characterized in that, The skeleton comprises a plurality of interwoven titanium alloy units (5), and the density of the titanium alloy units (5) of the connecting units (42) is smaller than the density of the titanium alloy units (5) of the braided mesh units (41).

4. The multi-segment gastric bypass stent according to claim 3, characterized in that, The support frame body (1) can be deformed, and the support frame body (1) includes two working states, a first working state: an expanded and released state in a patient's body; and a second working state: a contracted state during transportation and installation.

5. The multi-segment gastric bypass stent according to claim 4, characterized in that, In the second working state, the connection unit (42) is in a contracted state in both the radial and axial directions, and two adjacent woven mesh units (41) are arranged closely together.

6. The multi-segment gastric bypass stent according to claim 5, characterized in that, The isolation element (2) is a transparent silicone film.

7. The multi-segment gastric bypass stent according to claim 6, characterized in that, It also comprises a release component, wherein the release component is used to switch the support frame body (1) from the second working state to the first working state.

8. The multi-segment gastric bypass stent according to claim 7, characterized in that, It also includes an inner contraction member for limiting the support frame body (1) to a second working state, the inner contraction member includes a catgut (6) for contracting and tightening the support frame body (1), the catgut (6) being wound at the end of the fourth section (14).

9. The multi-segment gastric bypass stent according to claim 8, characterized in that, The release component comprises a guide component inserted into the support frame body (1), and the guide component comprises a high-frequency electric knife (7) inserted into the support frame body (1), and the high-frequency electric knife (7) is used to cut the catgut (6) and release the support frame body (1); an air bag (8) is arranged outside the high-frequency electric knife (7), and the expansion direction of the air bag (8) is arranged radially. In the second working state, the air bag (8) is arranged in contact with the support frame body (1); in the first working state, the air bag (8) is separated from the support frame body (1), so that the guide component is easy to be withdrawn from the support frame body (1); the high-frequency electric knife (7) is provided with an endoscopic camera (9).

10. A method for releasing a multi-stage gastric bypass stent, using the multi-stage gastric bypass stent as described in claim 9, characterized in that, The following steps are involved: S1. The catgut suture (6) contracts the support frame body (1) into the second working state. The high-frequency electrotome (7) is inserted into the support frame body (1), and the cutting head of the high-frequency electrotome (7) is attached to the thread take-up end of the catgut suture (6). The airbag (8) is inflated, and the guiding component is relatively fixed to the support frame body (1). S2. The multi-segment gastric bypass stent is inserted into the duodenum of the patient, and the endoscope camera (9) observes whether the multi-segment gastric bypass stent is properly placed. S3. After the multi-segment gastric bypass stent reaches the target position, the high-frequency electrotome (7) is energized to cut the catgut suture (6), and the support frame body (1) is released and expanded. The non-adjacent section (3) is adjacent to the hepatopancreatic ampulla. S4. The guiding component can then be withdrawn from the support frame body (1).

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