Apparatus for intestinal lumen wall isolation and assisted anastomosis

Abstract

Disclosed in the present invention is an apparatus for intestinal lumen wall isolation and assisted anastomosis, and the present invention relates to the technical field of medical instruments. The apparatus comprises a drainage stent, a soft plastic sheath, and an anastomosis stent. Both the drainage stent and the anastomosis stent are made of degradable and absorbable high-molecular polymer materials. The drainage stent is arranged at a proper position of the proximal end of an intestinal resection site and is configured for dilating and fixing the proximal intestinal segment. The soft plastic sheath connected to the drainage stent is configured for isolating the intestinal lumen wall. The movable anastomosis stent is arranged in the soft plastic sheath and is configured for supporting, anastomosing, and fixing the two resected ends of the intestinal segment. When only intestinal lumen wall isolation is needed, the anastomosis stent can be removed, one end of the soft plastic sheath connected to the drainage stent is arranged in the proximal resected intestinal segment, and the other end extends out of the anus through the distal intestinal segment after anastomosis. The present invention can conveniently perform anastomosis on the intestinal tract in accordance with its physiology, and can also completely isolate an anastomotic stoma from intestinal contents, preventing the development of anastomotic fistula to a maximum extent.

Description

A device for isolating intestinal wall and assisting anastomosis Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a device that can be used for isolating intestinal cavity walls and assisting anastomosis. Background Art

[0002] With the accelerated pace of modern life and the influence of unhealthy eating habits, the incidence of colorectal cancer is increasing year by year. In various colorectal anastomosis surgeries using both manual suturing and tubular staplers, anastomotic fistulas are a common complication, with an incidence of approximately 2% to 20%. The closer the anastomosis is to the anus, the higher the incidence, especially in surgeries for low-lying rectal cancers. After resection of intestinal lesions, the intestinal ends need to be re-anastomosed. If the intestinal anastomosis does not heal properly and fistulas develop, intestinal contents can flow into the abdominal cavity, potentially causing abdominal or even systemic infection, leading to serious life-threatening complications or even death. Fistulas not only increase the risk of complications and death for patients, but also increase their suffering and medical burden.

[0003] Conventional manual suturing is more in line with the physiological healing of the intestine, but it is time-consuming and labor-intensive. While using a tubular stapler simplifies the procedure, the suturing process relies on titanium staples, which can permanently remain in the intestinal wall.

[0004] The current clinical practice for preventing anastomotic fistulas is to perform a temporary intestinal diversion (drainage) during intestinal anastomosis surgery, create a stoma in the abdominal wall, use a drainage bag, and provide daily care. Several months later, after the anastomosis has fully healed, intestinal restoration surgery is performed. This severely reduces the patient's quality of life, causes the pain of a second surgery, and increases the medical burden on all parties involved.

[0005] Summary of the Invention

[0006] The purpose of the present invention is to provide a device that can be used for isolating the intestinal wall and assisting anastomosis to solve the problems existing in the above-mentioned prior art. It can not only conveniently perform anastomosis of the intestine in accordance with its physiology, but also completely isolate the anastomosis from the intestinal contents, thereby preventing the occurrence of anastomotic fistula to the greatest extent.

[0007] To achieve the above object, the present invention provides the following solutions:

[0008] The present invention provides a device for isolating the intestinal wall and assisting anastomosis, comprising: a soft plastic film sleeve, one end of which is arranged at the proximal end of the intestinal tube at a suitable position at the cut-off point, and the other end of which extends to the outside of the anus through the distal end of the intestinal tube after the cut-off point is anastomosed;

[0009] The distal end of the drainage stent is connected to the proximal end of the soft plastic film sleeve located in the proximal intestinal tube at the disconnection site. The proximal end of the drainage stent is used to open the proximal intestinal tube at the disconnection site and guide intestinal contents into the soft plastic film sleeve.

[0010] The present invention comprises a drainage stent secured with surgical absorbable sutures within an intestinal cavity at a location appropriate for the proximal intestinal incision at the intestinal anastomosis, thereby opening the proximal intestinal tract at the severance and guiding intestinal contents completely into the drainage stent cavity. A flexible plastic film sleeve of a suitable length is removably and seamlessly connected to the distal end of the drainage stent, allowing the contents to enter the flexible plastic film sleeve through the drainage stent cavity, and the distal end of the flexible plastic film sleeve extends out of the anus through the distal intestinal tract. If the anastomosis is located in a low rectum, the two intestinal tract ends are anastomosed with a surgical tube-type stapler, and then the flexible plastic film sleeve at the distal end is pulled out of the anus through the rectum and anal canal using a surgical instrument for drainage of intestinal contents.

[0011] Optionally, an anastomotic stent is further included, which can be movably disposed within the soft plastic sleeve and used to support and anastomose the two intestinal ends. When the anastomosis is located in the colon, a device with an anastomotic stent can be used to insert the two intestinal ends to be anastomosed into the middle part of the stent, and then absorbable surgical sutures can be used to firmly connect and fix the two intestinal ends to the soft plastic sleeve.

[0012] Optionally, the drainage stent and the anastomosis stent are made of the same material, both of which are made of degradable and absorbable high molecular polymer materials. The drainage stent and the anastomosis stent can rupture and disintegrate after being retained in the body for a set time, and are discharged from the human body successively through the soft plastic film sleeve set in the intestinal tract.

[0013] Optionally, the soft plastic film sleeve is made of soft plastic material, such as latex or silicone.

[0014] Optionally, the drainage stent is provided with a trumpet-shaped mouth at one end, and the outer wall of the trumpet-shaped mouth is provided with an annular concave structure to facilitate suture binding and fixation, and the maximum outer diameter of the drainage stent matches the inner diameter of the cavity of the severed intestinal tube; the trumpet-shaped mouth of the proximal end of the drainage stent is inserted into the proximal intestinal tube at an appropriate position at the severance, and the drainage stent is fixed to the proximal intestinal tube at an appropriate position at the severance by absorbable surgical sutures; the distal end of the drainage stent is fixedly inserted into the soft plastic film sleeve, and the drainage stent ruptures and disintegrates after being retained in the body for a certain period of time, and its fragments are discharged from the human body one after another along with the soft plastic film sleeve.

[0015] Optionally, both ends of the drainage stent are provided with a trumpet mouth, the outer wall of the trumpet mouth is provided with an annular concave structure, and the maximum outer diameter of the drainage stent matches the inner diameter of the intestinal cavity of the severed intestinal tube; the proximal end of the drainage stent is inserted into the proximal intestinal tube at an appropriate position at the severance, and the drainage stent is fixed to the proximal intestinal tube at an appropriate position at the severance by absorbable surgical sutures; the distal end of the drainage stent is fixedly inserted into the soft plastic film sleeve, and the drainage stent ruptures and disintegrates after being retained in the body for a certain period of time, and its fragments are discharged from the human body one after another along with the soft plastic film sleeve.

[0016] Optionally, the anastomosis stent includes a connecting tube, and trumpet-shaped openings are integrally formed at both ends of the connecting tube. The maximum diameter of the anastomosis stent is the same as the inner diameter of the intestinal cavity of the severed intestinal tube; the distal end of the intestinal tube at the severed part of the intestinal tube is fixed to the distal end of the anastomosis stent near its incision position through an absorbable surgical suture, and the proximal end of the intestinal tube at the severed part of the intestinal tube is fixed to the proximal end of the anastomosis stent near its incision position through an absorbable surgical suture. After being retained in the body for a certain period of time, the anastomosis stent ruptures and disintegrates, and its fragments are discharged from the human body along with the intestine.

[0017] Optionally, after the proximal end of the drainage stent is passed through the intestinal tube at an appropriate position proximal to the intestinal severance, the drainage stent is tied and fixed to the outer wall of the intestinal tube at an appropriate position proximal to the intestinal severance using absorbable surgical sutures.

[0018] Compared with the prior art, the present invention has achieved the following technical effects:

[0019] Compared to traditional procedures using tubular staplers, this method eliminates residual titanium staples. Compared to traditional manual surgical suture anastomosis, it facilitates intestinal anastomosis. This method allows for convenient and physiological intestinal anastomosis while completely isolating the anastomotic stoma, minimizing the risk of anastomotic fistulas. The drainage stent and anastomotic stent are made of medically biodegradable materials. After the anastomosis heals, both the stent and the soft plastic film sleeve can be expelled from the body, leaving no residue. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the drawings required for use in the embodiments. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative work.

[0021] FIG1 is a schematic structural diagram of a device for isolating the intestinal wall and assisting anastomosis in accordance with a first embodiment of the present invention;

[0022] FIG2 is a schematic diagram of the structure of the drainage stent in Example 1 of the present invention;

[0023] FIG3 is a schematic diagram of the structure of the anastomotic stent in Example 1 of the present invention;

[0024] FIG4 is a schematic diagram of the structure of the soft plastic film sleeve in Example 1 of the present invention;

[0025] FIG5 is a schematic diagram of the intestinal tube at the distal end of the incision and the intestinal tube at the proximal end of the incision before anastomosis of the present invention;

[0026] FIG6 is a schematic diagram of the anastomosis process of the intestinal tract at the distal end of the incision and the intestinal tract at the proximal end of the incision in Example 1 of the present invention;

[0027] FIG7 is a schematic diagram of anastomosis of the intestinal tract at the distal end of the incision and the intestinal tract at the proximal end of the incision in Example 1 of the present invention;

[0028] FIG8 is a schematic structural diagram of a device for isolating the intestinal wall and assisting anastomosis in accordance with the second embodiment of the present invention;

[0029] FIG9 is a schematic diagram of the anastomosis process of the intestinal tract at the distal end of the incision and the intestinal tract at the proximal end of the incision in Example 2 of the present invention;

[0030] FIG10 is a schematic diagram of anastomosis of the intestinal tract distal to the incision and the intestinal tract proximal to the incision in Example 2 of the present invention;

[0031] FIG11 is a schematic diagram of the location of the excised lesion in the human body before use of the present invention;

[0032] FIG12 is a schematic diagram of the placement of the device in the human body during specific use according to the first embodiment of the present invention;

[0033] FIG13 is a schematic diagram of the placement of the device in the human body during specific use according to the second embodiment of the present invention.

[0034] In the figure: 1-drainage stent, 2-anastomosis stent, 3-soft plastic film sleeve, 4-proximal intestinal tube, 5-distal intestinal tube, 6-purse string suture, 7-surgical suture, 8-anus, 9-forceps, 10-colon, 11-rectum. DETAILED DESCRIPTION

[0035] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. 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 making creative efforts are within the scope of protection of the present invention.

[0036] The purpose of the present invention is to provide a device that can be used for isolating the intestinal wall and assisting anastomosis to solve the problems existing in the above-mentioned prior art. It can not only conveniently perform anastomosis of the intestine in accordance with its physiology, but also completely isolate the anastomosis from the intestinal contents, thereby preventing the occurrence of anastomotic fistula to the greatest extent.

[0037] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0038] Example 1

[0039] Referring to Figures 1 to 7, this embodiment provides a device that can be used for isolating the intestinal wall and assisting anastomosis. It is used for incision-assisted anastomosis at locations such as the small intestine or colon 10. Because it is located in the abdominal cavity, it is convenient to perform an anastomosis outside the abdominal wall after the abdominal incision. Therefore, in this embodiment, a soft plastic film sleeve 3, a drainage stent 1, and an anastomosis stent 2 are used to assist in the anastomosis of the intestinal tract at the disconnection site. The drainage stent 1 and the anastomosis stent 2 are made of the same material and are made of a degradable and absorbable polymer material. For example, they can be made of polyglycolic acid (PGA). The drainage stent 1 and the anastomosis stent 2 can rupture and disintegrate after being in the body for a set time, and are released along with the soft plastic film sleeve. 3 are successively discharged from the human body; the soft plastic film sleeve 3 is made of soft plastic material, such as latex or silicone, the proximal end of the soft plastic film sleeve 3 is arranged in the proximal intestinal tube 4 at the disconnection site, and the distal end extends to the outside of the anus 8 through the distal intestinal tube 5 at the disconnection site; the distal end of the drainage stent 1 is connected to the proximal end of the soft plastic film sleeve 3 located in the proximal intestinal tube 4 at the disconnection site, and the proximal end of the drainage stent 1 is used to open the proximal intestinal tube 4 at the disconnection site and guide the intestinal contents into the soft plastic film sleeve 3; the anastomosis stent 2 can be movably placed in the soft plastic film sleeve 3, and its two ends are respectively located in the distal intestinal tube 5 and the proximal intestinal tube 4 at the disconnection site, for supporting and anastomosing the two disconnected intestinal tubes.

[0040] In this embodiment, the drainage stent 1 is secured with surgical absorbable sutures at a suitable position within the intestinal cavity proximal to the incision of the proximal end of the intestinal tube 4 at the intestinal anastomosis, thereby opening the proximal end of the intestinal tube 4 at the incision and guiding the intestinal contents completely into the cavity of the drainage stent 1. The distal end of the drainage stent 1 is detachably and seamlessly connected to a soft plastic film sleeve 3 of a suitable length. Inside the soft plastic film sleeve 3, another disintegratable anastomosis stent 2 is pre-installed at an appropriate position away from the drainage stent 1. When the anastomosis stent 2 is needed to support and anastomose the intestinal tube, the two ends of the intestinal tube to be anastomosed can be sheathed in the middle of the anastomosis stent 2, and then the two ends of the intestinal tube to be anastomosed can be firmly docked and fixed to the soft plastic film sleeve 3 with surgical absorbable sutures 7. The soft plastic film sleeve 3 at the distal end of the anastomosis stent 2 can be pulled out of the anus 8 through the rectum and anal canal by surgical instruments for the excretion of intestinal contents.

[0041] In a specific embodiment, the drainage stent 1 is a tubular structure with a lumen, a trumpet mouth is opened at its proximal end, and an annular concave structure is provided on the outer wall of the trumpet mouth to facilitate the clamping and fixing of the suture line. After the proximal end of the drainage stent 1 is inserted into the proximal intestinal tube 4 at an appropriate position at the severance, an absorbable surgical suture 7 is used to tie and fix the drainage stent 1 to the proximal intestinal tube 4 at an appropriate position at the severance on the outside of the intestinal tube. When the drainage stent 1 disintegrates, the surgical suture 7 can be absorbed by the intestine and will not limit the inner diameter of the intestine here. The maximum outer diameter of the drainage stent 1 matches the inner diameter of the intestinal cavity of the proximal end of the intestinal tube 4 at the severance, so that it can stretch the intestinal wall and fit tightly with the inner wall of the intestine to prevent leakage of contents; the distal end of the drainage stent 1 is fixedly inserted into the soft plastic film sleeve 3, and the proximal end of the drainage stent 1 has an inwardly concave ring-shaped trumpet, which is secured to a proximal position in the intestinal cavity suitable for the intestinal anastomosis with surgical absorbable sutures, thereby stretching the intestinal tube and guiding the intestinal contents completely into the cavity of the drainage stent.

[0042] The specific structure of the drainage stent 1 of the present invention is not limited. In another preferred embodiment, in order to fix the drainage stent 1 to one end of the soft plastic film sleeve 3, a trumpet structure can be integrally formed at both ends of the drainage stent 1 to facilitate respectively expanding and fixing the soft plastic film sleeve 3 and the intestinal tube 4 proximal to the severance, so that intestinal contents can completely pass through the drainage stent 1 into the soft plastic film sleeve 3, thereby isolating the intestinal lumen wall and preventing direct contact between the contents and the anastomotic stoma.

[0043] In this embodiment, the structure of the anastomosis bracket 2 is similar to that of the drainage bracket 1, which includes a connecting tube with trumpet-shaped openings integrally formed at both ends of the connecting tube. The maximum diameter of the anastomosis bracket 2 is the same as the inner diameter of the intestinal cavity of the severed intestinal tube; the intestinal tube 5 at the distal end of the severed part is fixed to the distal end of the anastomosis bracket 2 near its incision position through an absorbable surgical suture 7, and the intestinal tube 4 at the proximal end of the severed part is fixed to the proximal end of the anastomosis bracket 2 near its incision position through an absorbable surgical suture 7. In the natural state, the outer diameter of the anastomosis bracket 2 matches the inner diameter of the intestinal cavity, and the anastomosis bracket 2 forms an inward concave structure, which is convenient for fixing the intestinal tube while expanding the intestinal cavity at both ends of the anastomosis bracket.

[0044] As shown in Figures 11 and 12, in this embodiment, a drainage stent 1 is secured to an appropriate position within the intestinal cavity of the proximal intestinal tube 4 at the site of the severance using surgical absorbable sutures. This serves to open the proximal intestinal tube 4 at the site of the severance and guide intestinal contents completely into the lumen of the drainage stent 1, ultimately expelling them from the body through the soft plastic film sleeve 3. Another disintegratable anastomosis stent 2 is pre-placed within the soft plastic film sleeve 3 at an appropriate distance from the drainage stent 1. When the anastomosis stent 2 is needed to support and anastomose the severance, the two intestinal ends to be anastomosed can be placed in the middle of the anastomosis stent. Surgical absorbable sutures are then used to securely connect the two intestinal ends to the soft plastic film sleeve 3, facilitating healing of the intestinal incision. This allows for convenient and physiological anastomosis of the intestine while also completely isolating the anastomosis to prevent anastomotic fistulas to the greatest extent possible. After the anastomosis has healed, the stent and film sleeve can be expelled from the body, leaving no residue.

[0045] Example 2

[0046] This embodiment provides a device that can be used for isolating the intestinal wall and assisting anastomosis, which is used for assisting anastomosis of the incision at the position of the rectum 11. Since the low rectum is close to the anus, it is not convenient to use an anastomosis stent to assist in intestinal anastomosis. Therefore, this embodiment omits the anastomosis stent structure and uses the same or similar drainage stent 1 and soft plastic film sleeve 3 as in the first embodiment to achieve the purpose of assisting anastomosis of the intestinal incision and isolating the intestinal wall.

[0047] As shown in Figures 8, 9, 10 and 13, the structure in this embodiment adopts a soft plastic film sleeve 3 and a drainage stent 1. The drainage stent 1 is made of a degradable and absorbable polymer material, for example, it can be made of polyglycolic acid (PGA). The drainage stent 1 can rupture and disintegrate after being indwelling in the body for a set time, and be discharged from the human body along with the soft plastic film sleeve 3; the soft plastic film sleeve 3 is made of a soft plastic material, such as latex or silicone. One end of the soft plastic film sleeve 3 is arranged in the proximal intestinal tube 4 at an appropriate position of the severance, and the other end extends to the outside of the anus 8 through the distal intestinal tube 5 of the severance. The distal end of the drainage stent 1 is connected to one end of the soft plastic film sleeve 3 located in the proximal intestinal tube 4 of the severance, and the proximal end of the drainage stent 1 is used to open the proximal intestinal tube 4 of the severance and guide the intestinal contents into the soft plastic film sleeve 3.

[0048] In this embodiment, the drainage stent 1 is secured to a suitable position within the intestinal cavity at the proximal end of the severed intestinal tube 4 using surgical absorbable sutures. This serves to open the proximal end of the severed intestinal tube 4 and guide the intestinal contents completely into the lumen of the drainage stent 1, ultimately draining the contents out of the body through the soft plastic sheath 3. The two severed ends of the intestinal tube are firmly docked and fixed to the soft plastic sheath 3 using surgical absorbable sutures, facilitating healing of the intestinal incision and enabling convenient and physiological anastomosis of the intestine. The anastomosis can also be completely isolated, minimizing the risk of anastomotic fistulas. After the anastomosis has healed, the stent and sheath can be expelled from the body, leaving no residue.

[0049] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only intended to help understand the method and core concept of the present invention. At the same time, those skilled in the art will find that the specific implementation methods and application scopes may vary based on the concept of the present invention. In summary, the contents of this specification should not be construed as limiting the present invention.

Claims

1. A device that can be used to isolate the intestinal wall and assist in anastomosis, characterized in that: include: A soft plastic film sleeve, one end of which is placed in the proximal intestinal tube at a suitable position at the cut-off site, and the other end extends to the outside of the anus through the distal intestinal tube after the cut-off site is anastomosed; The distal end of the drainage stent is connected to the proximal end of the soft plastic film sleeve located in the proximal intestinal tube at the disconnection site. The proximal end of the drainage stent is used to open the proximal intestinal tube at the disconnection site and guide intestinal contents into the soft plastic film sleeve.

2. The device for isolating the intestinal wall and assisting anastomosis according to claim 1, characterized in that: It also includes an anastomosis bracket, which can be movably arranged in the soft plastic film sleeve and can be used to support and anastomose the two broken ends of the intestinal tube.

3. The device for isolating the intestinal wall and assisting anastomosis according to claim 2, characterized in that: The drainage stent and the anastomosis stent are made of the same material, both of which are made of degradable and absorbable high molecular polymer materials. The drainage stent and the anastomosis stent can rupture and disintegrate after being retained in the body for a set time, and are discharged from the human body one after another through the soft plastic film sleeve set in the intestinal tract.

4. The device for isolating the intestinal wall and assisting anastomosis according to claim 1, characterized in that: The soft plastic film sleeve is made of soft plastic material.

5. The device for isolating the intestinal wall and assisting anastomosis according to claim 1, characterized in that: The drainage stent is provided with a trumpet-shaped mouth at one end, and the outer wall of the trumpet-shaped mouth is provided with an annular concave structure. The maximum outer diameter of the drainage stent matches the inner diameter of the intestinal cavity of the severed intestinal tube; the trumpet-shaped mouth of the proximal end of the drainage stent is inserted into the proximal intestinal tube at an appropriate position at the severed part, and the drainage stent is fixed to the proximal intestinal tube at an appropriate position at the severed part by absorbable surgical sutures; the distal end of the drainage stent is fixedly inserted into the soft plastic film sleeve.

6. The device for isolating the intestinal wall and assisting anastomosis according to claim 1, characterized in that: Both ends of the drainage stent are provided with a trumpet mouth, the outer wall of the trumpet mouth is provided with an annular concave structure, and the maximum outer diameter of the drainage stent matches the inner diameter of the intestinal cavity of the severed intestinal tube; the proximal end of the drainage stent is inserted into the proximal intestinal tube, and the drainage stent is fixed to the proximal intestinal tube at an appropriate position at the severed part by absorbable surgical sutures; the distal end of the drainage stent is fixedly inserted into the soft plastic film sleeve.

7. The device for isolating the intestinal wall and assisting anastomosis according to claim 1, characterized in that: The anastomosis bracket includes a connecting tube, and trumpet-shaped openings are integrally formed at both ends of the connecting tube. The maximum diameter of the anastomosis bracket is the same as the inner diameter of the intestinal cavity of the severed intestinal tube; the distal end of the intestinal tube at the severed part of the intestinal tube is fixed to the distal end of the anastomosis bracket near its incision position through an absorbable surgical suture, and the proximal end of the intestinal tube at the severed part of the intestinal tube is fixed to the proximal end of the anastomosis bracket near its incision position through an absorbable surgical suture.

8. The device for isolating the intestinal wall and assisting anastomosis according to claim 5 or 6, characterized in that: After the proximal end of the drainage stent is inserted into the intestinal tube at an appropriate position proximal to the intestinal severance, the drainage stent is tied and fixed to the outer wall of the intestinal tube at an appropriate position proximal to the intestinal severance using absorbable surgical sutures.

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