Internal flow turning device for colorectal anastomotic stoma protection

Abstract

The invention discloses an internal bypass device for colorectal anastomotic stoma protection, which comprises an intestinal tract internal stent, the intestinal tract internal stent is of a hollow pipeline structure with two open ends, and the diameter of the head end part of the intestinal tract internal stent is greater than that of the main body part of the intestinal tract internal stent; a plurality of annular outer fixing air bags are arranged on the outer side of the intestinal tract inner support from top to bottom in a surrounding mode, the outer fixing air bags are communicated with the air bag catheter, the tail end of the intestinal tract inner support is connected with the anastomotic stoma protection film, and the anastomotic stoma protection film is a flexible cylindrical thin film with the hollow interior and the two open ends. The end, away from the intestinal tract inner support, of the anastomotic stoma protection film is connected with a protection film end opening piece capable of being contracted and opened, and when the anastomotic stoma protection film is in the opened state, the outer side of the anastomotic stoma protection film is matched with the rectum anastomotic stoma in a right-facing mode. The stress of the anastomotic stoma can be reduced, local healing is promoted, leakage of the anastomotic stoma is effectively prevented, healing of the anastomotic stoma after the colorectal operation is effectively guaranteed, and the postoperative recovery process of a patient is remarkably promoted.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an internal flow diversion device for protecting colorectal anastomosis. Background Art

[0002] With the deepening of understanding of the biological behavior of rectal cancer, the proportion of anal preservation surgery for mid- and low-level rectal cancer is increasing, but anastomotic leakage is still one of the common serious complications after surgery, with an incidence of 3% to 24% and a related mortality rate of 6% to 26%. Anastomotic leakage not only affects the patient's postoperative recovery, but severe anastomotic leakage requires re-surgical intervention and may even affect the patient's long-term survival. How to reduce the incidence of anastomotic leakage and reduce the degree of harm after anastomotic leakage has always been a hot topic and difficulty in colorectal surgery.

[0003] Clinically, preventive stoma diversion of intestinal contents is often used to reduce the harm of anastomotic leakage, but this type of surgery brings many complications and inconveniences to patients. For example, stoma-related skin inflammation, infection, stoma retraction and stenosis seriously affect the quality of life of patients. In addition, secondary stoma reduction surgery is bound to cause additional secondary trauma to patients. In addition, anastomotic protection devices are also used to reduce the incidence of anastomotic leakage, but there are problems such as complex device application, unreliable fixation, patient discomfort, and inability to fully achieve internal drainage effects, which limit their promotion and application.

[0004] Based on this, the present invention provides an internal flow diversion device for protecting colorectal anastomosis, which can reduce the stress of the anastomosis, promote local healing, and effectively prevent the occurrence of anastomotic leakage, and is particularly suitable for patients with high-risk factors. Summary of the invention

[0005] In order to solve the defects of existing colorectal anastomotic stoma protection devices during use, such as complex placement operation, easy falling off, inability to fully isolate intestinal contents, and additional trauma to the human body, which leads to the inability to fully protect the anastomosis, the present invention provides an internal flow diversion device for colorectal anastomosis protection, which can reduce the stress of the anastomosis, promote local healing, effectively prevent the occurrence of anastomotic leakage, effectively ensure the healing of the anastomosis after colorectal surgery, and significantly promote the patient's postoperative recovery process.

[0006] In order to achieve the above object, the present invention adopts the following technical solutions: The present invention provides an internal flow diversion device for protecting colorectal anastomosis, comprising an intestinal stent, an external fixation balloon, a balloon catheter, an anastomotic stoma protection film and a protective film end expansion piece; The intestinal stent is a pipe structure with openings at both ends and a hollow interior. The diameter of the head end portion of the intestinal stent is larger than the diameter of the main body portion of the intestinal stent. A plurality of annular external fixing air bags are arranged around the outside of the intestinal stent from top to bottom. The external fixing air bags are connected to the air bag catheter. The tail end portion of the intestinal stent is connected to the anastomotic protective film. The anastomotic protective film is a flexible cylindrical film with a hollow interior and openings at both ends. The end of the anastomotic protective film away from the intestinal stent is connected to a protective film end expansion member that can shrink and expand. When the anastomotic protective film is in an expanded state, its outer side is directly aligned with the rectal anastomosis.

[0007] Furthermore, the protective film end expansion piece is an inflatable annular airbag structure, and the protective film end expansion piece is connected to the airbag catheter.

[0008] The end expansion piece of the protective film is a soft, inflatable and deformable annular airbag structure, which is fixed to the end of the anastomotic protective film and is used to continuously expand the anastomotic protective film. It can be adjusted as needed during use to provide better anastomotic protection while reducing pressure and damage to surrounding tissues.

[0009] Furthermore, the head end of the intestinal stent is divided into a trumpet-shaped structure with a gradually decreasing diameter, and the intestinal stent is made of polytetrafluoroethylene.

[0010] In a specific embodiment, the intestinal stent is designed as a hollow tube structure with the front end being shaped like a trumpet, which can more effectively collect intestinal contents, reduce overflow, and ensure smooth drainage of the contents, thereby facilitating postoperative recovery.

[0011] Furthermore, the intestinal stent is a dumbbell-shaped structure, and the diameters of the head end portion and the tail end portion of the intestinal stent are both larger than the diameter of the middle main body portion of the intestinal stent, and the intestinal stent is a metal mesh structure.

[0012] In another specific embodiment, the intestinal stent with a metal mesh structure can be deformed and bent to a certain extent, which is more suitable for the inside of the intestine and is relatively easy to operate and install. In addition, with the help of the end of the intestinal stent with a dumbbell-shaped structure, one end of the anastomotic protective membrane is stretched and fixed tightly to the upstream position of the rectal anastomosis.

[0013] Furthermore, the external fixed airbag is a ring-shaped airbag structure or a ring-shaped structure formed by connecting multiple airbag packages end to end in sequence, the airbag packages are interconnected, and after being inflated, the airbag packages are in a short hemispherical shape.

[0014] The external fixation balloon adopts an inflatable and deformable structure, which can be adjusted as needed during use to further isolate the intestinal contents, provide better anastomotic protection, and reduce pressure and damage to surrounding tissues.

[0015] The external fixation airbag can directly adopt a ring-shaped airbag structure. Preferably, the external fixation airbag is formed by connecting 4 airbag bags in sequence. The airbag bags are interconnected. After being inflated, the airbag bags are in a short hemispherical shape and cover the intestinal stent. The airbag catheter is connected to each external fixation airbag and serves as the inflation pipeline. The end of the airbag catheter is connected to a one-way air valve.

[0016] Furthermore, the surface of the external fixation airbag is evenly distributed with dot-shaped protrusions, and the friction between the inflated external fixation airbag and the inner side of the intestine is increased, so that the device has a better fixing effect and is not easy to move or detach.

[0017] Furthermore, the number of the external fixing airbags is an even number, and the external fixing airbags are symmetrically arranged at the outer sides of both ends of the intestinal stent. Preferably, each layer of external fixing airbags is staggered to further isolate the intestinal contents.

[0018] Furthermore, the spacing between the external fixing airbags at one end of the intestinal stent is smaller than the spacing between the external fixing airbags at both ends of the intestinal stent.

[0019] In a specific embodiment, four external fixation airbags are provided (i.e., four layers), the spacing between the 1st and 2nd layers and the 3rd and 4th layers is narrow, and the spacing between the 2nd and 3rd layers is wide, so that the number of external fixation airbags provided can be reduced, while also ensuring that the external fixation airbags contact the inner wall of the intestine after inflation to form sufficient fixing force and sealing effect.

[0020] Furthermore, it also includes a C-shaped fixing airbag, which is an inflatable structure. The C-shaped fixing airbag is located outside the intestine, and after being inflated, it is clamped to the outside of the intestine and clamped to the middle position of the stent in the intestine.

[0021] The C-shaped fixation balloon exists independently and is placed outside the intestine as an auxiliary fixation device. After being inflated, it is outside the intestinal tract and stuck between the second and third layers of the external fixation balloons on the intestinal stent, playing an auxiliary fixation role.

[0022] Furthermore, the anastomotic stoma protective membrane is made of polytetrafluoroethylene. Preferably, the anastomotic stoma protective membrane is a soft, compressible and stretchable cylindrical film.

[0023] The anastomotic protective membrane made of PTFE material has good biocompatibility and low friction coefficient, which can reduce the risk of postoperative adhesion and infection and promote the patient's recovery.

[0024] Compared with the prior art, the present invention has the following beneficial effects: 1. Effectively prevent anastomotic leakage: The design of the multi-layer external fixation airbag anastomotic protective film can effectively isolate the intestinal contents and prevent them from overflowing to the outside of the protective device, thereby reducing the risk of anastomotic leakage and improving the success rate of the operation.

[0025] 2. Enhanced fixation stability: As an auxiliary fixation device, the C-shaped fixation balloon can provide additional support and stability on the outside of the intestinal tract, prevent the internal diversion device from shifting, and thus better protect the anastomosis.

[0026] 3. Improve drainage effect: The intestinal stent is designed as a hollow tube structure with a trumpet-shaped head, which can more effectively collect intestinal contents, reduce overflow, and ensure smooth drainage of the contents, which helps postoperative recovery.

[0027] 4. Reduce postoperative complications: The anastomotic protective membrane made of PTFE material has good biocompatibility and low friction coefficient, which can reduce the risk of postoperative adhesion and infection and promote patient recovery.

[0028] 5. Flexible and adjustable design: The multi-layer external fixation airbag and protective film expansion device are designed as inflatable and deformable structures, which can be adjusted as needed during use to provide better anastomotic protection while reducing pressure and damage to surrounding tissues.

[0029] 6. Easy to operate and install: The overall structural design of the device is simple, and it is relatively easy to operate and install. It can be quickly and accurately positioned and fixed during surgery, improving the efficiency and safety of the surgery. BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0031] Figure 1 This is a schematic diagram of the internal flow diversion device in Example 1 after installation in the abdominal intestinal tract; Figure 2 It is a schematic diagram of the installation of the internal flow diversion device at the intestinal anastomosis in Example 1; Figure 3 It is a partial structural schematic diagram of the internal flow conversion device in Example 1; Figure 4 This is a schematic diagram of the structure of the external fixation airbag in Example 1; Figure 5 is a schematic diagram of the side structure of the airbag package in Example 1; Figure 6 This is a schematic diagram of the structure of the C-shaped fixed airbag in Example 1; Figure 7This is a schematic diagram of the internal flow diversion device in Example 2 after installation in the abdominal intestinal tract; Figure 8 It is a schematic diagram of the structure of the internal flow conversion device in Example 2; Among them, the specific drawings are marked as: Internal diversion device 1, intestinal stent 2, external fixing balloon 3, balloon bag 301, annular balloon 302, dot-shaped protrusions 303, balloon catheter 4, anastomotic protective film 5, protective film end expansion piece 6, C-shaped fixing balloon 7. DETAILED DESCRIPTION

[0032] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0033] Example 1 This embodiment provides an internal flow diversion device for colorectal anastomosis protection. Figure 1 FIG. 1 is a schematic diagram of the internal diversion device 1 after installation in the abdominal intestinal tract. Figure 2 and Figure 3 As shown, the internal flow diversion device 1 includes an intestinal stent 2, an external fixation balloon 3, a balloon catheter 4, an anastomotic protective film 5 and a protective film end expansion piece 6; The intestinal stent 2 is a pipe structure with openings at both ends and a hollow interior. The diameter of the head end portion of the intestinal stent 2 is larger than the diameter of the main portion of the intestinal stent 2. A plurality of annular external fixing air bags 3 are arranged around the outside of the intestinal stent 2 from top to bottom. The external fixing air bags 3 are connected to the air bag catheter 4. The tail end portion of the intestinal stent 2 is connected to the anastomotic stoma protective film 5. The anastomotic stoma protective film 5 is a flexible cylindrical film with a hollow interior and openings at both ends. The end of the anastomotic stoma protective film 5 away from the intestinal stent 2 is connected to a protective film end expansion member 6 that can be contracted and expanded. When the anastomotic stoma protective film 5 is in an expanded state, its outer side is directly aligned with the rectal anastomosis.

[0034] The protective film end stretching member 6 is an inflatable annular airbag structure, and the protective film end stretching member 6 is connected to the airbag catheter 4. Specifically, the protective film end stretching member 6 is a soft, inflatable and deformable annular airbag structure, fixed to the end of the anastomotic stoma protective film 5, and is used to continuously stretch the anastomotic stoma protective film 5. It can be adjusted as needed during use to provide a better anastomotic stoma protection effect, while reducing pressure and damage to surrounding tissues.

[0035] The head end of the intestinal stent 2 is a trumpet-shaped structure with a gradually decreasing diameter, and the intestinal stent 2 is made of polytetrafluoroethylene. The intestinal stent 2 is designed as a hollow pipe structure, and the head end is a trumpet-shaped structure, which can more effectively collect intestinal contents, reduce overflow, and ensure smooth drainage of the contents, which is helpful for postoperative recovery.

[0036] Among them, Figure 4 As shown, the external fixation airbag 3 is a ring structure formed by connecting multiple airbag packages 301 end to end in sequence, the airbag packages 301 are interconnected, and the airbag packages 301 are in a short hemispherical shape after being inflated. The external fixation airbag 3 adopts an inflatable and deformable structure, which can be adjusted as needed during use to further isolate the intestinal contents, provide better anastomotic protection, and reduce pressure and damage to surrounding tissues.

[0037] Preferably, the external fixed airbag 3 is formed by four airbag bags 301 connected in sequence, and the airbag bags 301 are interconnected. After being inflated, the airbag bags 301 are in a short hemispherical shape and cover the intestinal stent 2. The airbag catheter 4 is connected to each external fixed airbag 3 and serves as an inflation pipeline. The end of the airbag catheter 4 is connected to a one-way air valve.

[0038] Preferably, if Figure 5 As shown, the surface of the external fixation balloon 3 is evenly distributed with dot-shaped protrusions 303. The friction force when the inflated external fixation balloon 3 contacts the inner side of the intestine is increased, and the device has a better fixing effect and is not easy to move or detach.

[0039] Specifically, the number of external fixing airbags 3 is an even number, and the external fixing airbags 3 are symmetrically arranged at the outer sides of the two ends of the intestinal stent 2. Preferably, each layer of external fixing airbags 3 is staggered to further isolate the intestinal contents. The spacing between the external fixing airbags 3 located at one end of the intestinal stent 2 is smaller than the spacing between the external fixing airbags 3 located at both ends of the intestinal stent 2. In a specific embodiment, four (i.e., four layers) of external fixing airbags 3 are provided, the spacing between the 1st and 2nd layers and the 3rd and 4th layers is narrow, and the spacing between the 2nd and 3rd layers is wide, so that the number of external fixing airbags 3 can be reduced, and at the same time, it is ensured that the external fixing airbags 3 are in contact with the inner wall of the intestine after inflation to form sufficient fixing force and sealing effect.

[0040] The internal diversion device 1 further includes a C-shaped fixed airbag 7, such as Figure 2 and Figure 6As shown, the C-shaped fixing airbag 7 is an inflatable structure, which is located outside the intestine. After being inflated, it is clamped to the outside of the intestine and clamped to the middle position of the intestinal stent 2. The C-shaped fixing airbag 7 exists independently and is placed outside the intestine as an auxiliary fixing device. After being inflated, it is outside the intestinal tube and clamped into the position between the second and third layers of the external fixing airbags 3 on the intestinal stent 2, assuming the role of auxiliary fixing.

[0041] The anastomotic stoma protective film 5 is made of polytetrafluoroethylene, and preferably, the anastomotic stoma protective film 5 is a soft, compressible and stretchable cylindrical film. The anastomotic stoma protective film 5 made of PTFE material has good biocompatibility and low friction coefficient, can reduce the risk of postoperative adhesion and infection, and promote the patient's recovery.

[0042] 1: Production and application of trumpet-shaped intestinal stent 2 1) Material selection: Medical grade polytetrafluoroethylene (PTFE) is used as the main material to ensure its good biocompatibility and chemical resistance.

[0043] 2) Bracket production: a) A tubular intestinal stent 2 with two ends open and a hollow interior is prepared, with a length of 6 cm and an inner diameter of 2 cm.

[0044] b) The head end of the intestinal stent 2 is processed into a trumpet shape with a diameter of 2.5 cm to facilitate the collection of intestinal contents.

[0045] c) The intestinal stent 2 is surrounded by a plurality of annular external fixing balloons 3, with a total of 4 layers, and each layer is arranged alternately.

[0046] 3) Installation and fixing: a) Place the intestinal stent 2 at the patient's colorectal anastomosis through minimally invasive surgery, ensuring that the flared opening faces the inside of the intestine.

[0047] b) Use an external independent C-shaped fixation airbag 7 for auxiliary fixation to ensure that the stent is stable and does not shift.

[0048] 2: Design and function of external fixation balloon 3 1) Airbag production: a) Each layer of airbag is made of medical silicone to ensure softness and durability.

[0049] b) Each layer of external fixed airbags 3 is formed by connecting four airbag packages 301. After being inflated, the airbag packages 301 are in a short hemispherical shape, and dot-shaped protrusions 303 are evenly distributed on the surface.

[0050] 2) Airbag layout: a) The multi-layer external fixation airbag 3 is divided into 4 layers in total. The spacing between the 1st and 2nd layers and the 3rd and 4th layers is relatively narrow, and the spacing between the 2nd and 3rd layers is relatively wide, so as to improve the isolation effect.

[0051] b) Each layer of external fixation airbags 3 is interconnected through an airbag catheter 4, and a one-way air valve is connected to the end of the airbag catheter 4 to facilitate inflation and deflation adjustment.

[0052] 3) Functional implementation: a) When in use, the airbag catheter 4 is inflated to expand the airbag bag 301 to provide additional support and isolation.

[0053] b) The inflated airbag bag 301 can further enhance the isolation effect of the intestinal contents and prevent them from overflowing.

[0054] 3: Application of anastomotic protective film 5 and protective film end stretching member 6 1) Production of anastomotic protective film 5: a) Made of PTFE film with a thickness of 0.1mm, ensuring its soft, compressible and stretchable properties.

[0055] b) The anastomotic protective membrane 5 is connected to the intestinal stent 2 on the head side and connected to the protective membrane end expansion piece 6 on the tail side.

[0056] 2) Design of the protective film end support piece 6: a) The protective film end expansion piece 6 is a soft and deformable ring with a diameter of 2 cm, which is fixed to the end of the anastomotic protective film 5.

[0057] b) The ring can continuously stretch the protective membrane during use to ensure effective coverage in the intestine.

[0058] 3) Application method: a) Install the anastomotic stoma protective film 5 on the intestinal stent 2 to ensure that the head side of the anastomotic stoma protective film 5 is tightly connected to the intestinal stent 2.

[0059] b) Use the protective film end expansion piece 6 to fix the tail side of the anastomotic protective film 5 to ensure the effective expansion and covering of the anastomotic protective film 5 in the intestine.

[0060] 4: Auxiliary fixation of C-shaped fixed airbag 7 1) Airbag production: a) A C-shaped fixing airbag 7 is made of medical grade silicone material and can be inserted into the outside of the intestine after being inflated.

[0061] 2) Installation method: a) After the intestinal stent 2 and the multi-layer external fixation balloon 3 are installed, the C-shaped fixation balloon 7 is placed outside the intestine and inflated.

[0062] b) After being inflated, the C-shaped fixing airbag 7 is inserted between the second and third layers of the external fixing airbag 3 on the intestinal stent 2 to provide additional support and fixation.

[0063] 3) Functional implementation: a) The auxiliary fixation of the C-shaped fixing balloon 7 can prevent the internal diversion device 1 from shifting in the intestine and ensure its stability.

[0064] Example 2 This embodiment provides an internal flow diversion device for colorectal anastomosis protection, which is different from the embodiment 1 in that: like Figure 7 and Figure 8 As shown, in this embodiment, the intestinal stent 2 is a dumbbell-shaped structure, and the diameters of the head end and the tail end of the intestinal stent 2 are larger than the diameter of the middle main body of the intestinal stent 2, and the intestinal stent 2 is a metal mesh structure. The intestinal stent 2 with a metal mesh structure can be deformed and bent to a certain extent, and is more suitable for the inside of the intestine. It is relatively easy to operate and install, and with the help of the end of the intestinal stent 2 with a dumbbell-shaped structure, one end of the anastomotic protective film 5 is stretched and fixed to the upstream position of the rectal anastomosis. The external fixation balloon 3 adopts a simple circular ring balloon 302.

[0065] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. An internal flow diversion device for colorectal anastomosis protection, characterized in that: It includes an intestinal stent, an external fixation balloon, a balloon catheter, an anastomotic protective film and a protective film end expansion piece; The intestinal stent is a pipe structure with openings at both ends and a hollow interior. The diameter of the head end portion of the intestinal stent is larger than the diameter of the main body portion of the intestinal stent. A plurality of annular external fixing air bags are arranged around the outside of the intestinal stent from top to bottom. The external fixing air bags are connected to the air bag catheter. The tail end portion of the intestinal stent is connected to the anastomotic protective film. The anastomotic protective film is a flexible cylindrical film with a hollow interior and openings at both ends. The end of the anastomotic protective film away from the intestinal stent is connected to a protective film end expansion member that can shrink and expand. When the anastomotic protective film is in an expanded state, its outer side is directly aligned with the rectal anastomosis.

2. The internal flow diversion device for colorectal anastomosis protection according to claim 1, characterized in that: The protective film end expansion piece is an inflatable annular airbag structure, and the protective film end expansion piece is connected to the airbag catheter.

3. The internal flow diversion device for colorectal anastomosis protection according to claim 1, characterized in that: The head end of the intestinal stent is divided into a trumpet-shaped structure with a gradually decreasing diameter, and the intestinal stent is made of polytetrafluoroethylene.

4. The internal flow diversion device for colorectal anastomosis protection according to claim 1, characterized in that: The intestinal stent is a dumbbell-shaped structure, and the diameters of the head end portion and the tail end portion of the intestinal stent are both larger than the diameter of the middle main body portion of the intestinal stent. The intestinal stent is a metal mesh structure.

5. The internal flow diversion device for colorectal anastomosis protection according to claim 3 or 4, characterized in that: The external fixed airbag is a circular airbag structure or a ring structure formed by connecting a plurality of airbag packages end to end in sequence. The airbag packages are interconnected and are in a short hemispherical shape after being inflated.

6. The internal flow diversion device for colorectal anastomosis protection according to claim 5, characterized in that: The surface of the external fixation airbag is evenly distributed with dot-shaped protrusions.

7. The internal flow diversion device for colorectal anastomosis protection according to claim 5, characterized in that: The number of the external fixing airbags is an even number, and the external fixing airbags are symmetrically arranged at the outer sides of both ends of the intestinal stent.

8. The internal flow diversion device for colorectal anastomosis protection according to claim 7, characterized in that: The spacing between the external fixing airbags at one end of the intestinal stent is smaller than the spacing between the external fixing airbags at both ends of the intestinal stent.

9. The internal flow diversion device for colorectal anastomosis protection according to claim 5, characterized in that: It also includes a C-shaped fixing airbag, which is an inflatable structure. The C-shaped fixing airbag is located outside the intestine, and after being inflated, it is clamped to the outside of the intestine and clamped to the middle position of the intestinal stent.

10. The internal flow diversion device for colorectal anastomosis protection according to claim 1, characterized in that: The anastomotic protective film is made of polytetrafluoroethylene.

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