Device and method for preventing anastomotic fistula after colorectal surgery

Abstract

The present invention discloses a method for preventing anastomotic fistula after colorectal surgery, comprising the following steps: 1: preoperative preparation and partial resection of the colorectal lesion, and suturing the anastomosis; 2: installing a support and protective net to protect the anastomosis; 3: introducing a fixed portion at the head end of a catheter from the anus along the intestine to the ileocecal valve, inflating the fixed portion so that the fixed portion is stuck at the ileocecal valve, and the catheter position is relatively fixed with the ileocecal valve by the fixed portion, thereby performing a double blockage on the intestine and simultaneously draining intestinal contents through the catheter; and 4: after the patient's anastomosis is healed, venting the catheter, and withdrawing the catheter and the fixed portion from the ileocecal valve through the anus. The present invention can prevent anastomotic fistula, facilitates wound healing, and only requires surgical suturing of the anastomosis, eliminating the need for surgical opening and suturing of other parts. This reduces the physical trauma caused by the surgery to the patient, helps improve the patient's quality of life after surgery, and is applicable to the field of medical device technology.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular relates to a device and method for preventing anastomotic fistula after colorectal surgery. Background Art

[0002] Colorectal cancer (CRC) is a common malignant tumor of the gastrointestinal tract. Early symptoms are mild, but as the tumor grows, symptoms develop, including changes in bowel habits, blood in the stool, diarrhea, alternating diarrhea and constipation, and localized abdominal pain. In the late stages, systemic symptoms such as anemia and weight loss appear. Its morbidity and mortality rates are second only to gastric cancer, esophageal cancer, and primary liver cancer among digestive system malignancies. Surgical resection is the most effective treatment for colorectal cancer. However, anastomotic leakage is a common clinical complication. Initially, the incidence in China was approximately 20%. With the continuous advancement of medical technology, this has now decreased to approximately 5%. Treatment of anastomotic leakage is difficult, and conventional methods include colon or terminal ileostomy, which allows intestinal contents to be drained away from the anastomosis to prevent or reduce leakage. However, this approach also increases surgical trauma, reduces the patient's quality of life, and requires a secondary surgery to restore the bowel, which increases the complication rate.

[0003] Invention patent document with application number 201520831301.9, such as Figure 6 As shown, a double-balloon enterostomy catheter for preventing anastomotic fistula after colorectal surgery is disclosed, comprising a catheter body, a first balloon, a second balloon, a threaded pressing piece, a first water injection port and a second water injection port; the catheter body is a hollow tube structure, with a head end and a tail end respectively; the first balloon and the second balloon are two hollow balloons made of elastic material and are sleeved on the catheter body; wherein the first balloon is close to the head end; the second balloon is located between the first balloon and the tail end; the threaded pressing piece is sleeved on the catheter body between the second balloon and the tail end by threaded engagement; a side hole is provided on the tube wall of the catheter body between the first balloon and the head end; the first water injection port and the second water injection port are located at the tail end of the catheter body; the first water injection port is connected to and communicated with the first balloon through a first connecting pipe; the second water injection port is connected to and communicated with the second balloon through a second connecting pipe. It uses one balloon and a threaded pressing piece to position the catheter, and another balloon to block the intestinal contents and discharge them through the catheter. On the one hand, it requires abdominal surgery, causing unnecessary trauma to the patient. On the other hand, the blocking effect of a single balloon on intestinal contents is not ideal. Summary of the Invention

[0004] The present invention provides a method for preventing anastomotic fistula after colorectal surgery, which can prevent anastomotic fistula without causing unnecessary surgical trauma to the patient, thereby improving the patient's postoperative quality of life.

[0005] To achieve the above object, the technical solution adopted by the present invention includes the following steps:

[0006] Step 1: Preoperative preparation and partial resection of colorectal lesions and suturing of anastomosis;

[0007] Step 2: Install a degradable support and protection net through the mounting bracket to protect the anastomosis;

[0008] Step 3: The fixing portion of the catheter head end, which is adapted to the ileocecal valve structure, is introduced from the anus along the intestine to the ileocecal valve. The fixing portion is inflated so that it is stuck at the ileocecal valve. The fixing portion fixes the position of the catheter relative to the ileocecal valve, thereby achieving a double occlusion of the intestine and simultaneously draining the intestinal contents through the catheter.

[0009] Step 4: After the anastomosis is healed, the catheter is deflated and the catheter and the fixation part are removed from the ileocecal valve through the anus.

[0010] Step 5: Clean the anastomosis.

[0011] The present invention also discloses a device for preventing anastomotic fistula after colorectal surgery, comprising a catheter introduced into the ileocecal valve position through the anus and intestine, and an inflatable fixing portion adapted to the ileocecal valve structure and fixed at the ileocecal valve position is provided near the front end of the catheter, the front end of the catheter is provided with holes for drug administration, flushing and intestinal content discharge, the rear end of the catheter is provided with an inflation port and an excretion port, and the interior of the catheter is provided with a guide portion for the catheter to be passed through the intestine; the fixing portion is a gourd-shaped or dumbbell-shaped structure, comprising a first balloon and a second balloon connected by a transition section, the catheter passes through the middle of the transition section, the first balloon and the second balloon, and the first balloon and the second balloon are connected to the inflation port through the trachea; the outer wall structure of the first balloon and the second balloon is conducive to fitting the protrusion of the intestinal wall.

[0012] Furthermore, the tail end of the catheter is also provided with a drug administration and flushing port, and the inflation port, the excretion port, and the drug administration and flushing port are all provided with a sealing cover connected to the catheter.

[0013] Furthermore, the guide portion includes a guide wire, an indicator light and a camera. The guide wire is arranged in the catheter, and the indicator light and the camera are arranged at the head end of the guide wire to accurately determine the position of the catheter during use.

[0014] Furthermore, a support and protection piece is provided at the position of the colorectal anastomosis. The support and protection piece is mounted on the outside of the side wall of the catheter through a mounting bracket and is located at the anastomosis of the inner wall of the intestine.

[0015] Furthermore, the supporting protection member is made of biodegradable material.

[0016] Furthermore, the catheter and the fixing portion are made of silicone.

[0017] Due to the adoption of the above structure, the present invention has made technical progress compared with the prior art in that: the head end of the catheter is provided with a fixing part of a double-balloon structure adapted to the ileocecal valve structure, the head end of the catheter is introduced from the anus through the intestine, so that the fixing part is located at the position of the ileocecal valve, the fixing part of the double-balloon structure is inflated, and the fixing part of the double-balloon structure is stuck at the position of the ileocecal valve, so that the intestinal contents are effectively blocked to prevent leakage, and are discharged from the tail end of the catheter through the excretion port. When the catheter needs to be removed, the fixing part can be deflated and the catheter can be pulled out of the intestine. On the one hand, except for the necessary surgical suturing of the anastomosis, there is no need When performing surgery on the abdomen or other parts of the human body, no unnecessary trauma will be caused, and no secondary surgery is required, which reduces the patient's pain and improves the patient's quality of life after surgery; on the other hand, the fixed structure of the double-balloon structure is compatible with the ileocecal valve structure, with large ends and a small middle, which is just stuck in this position, which can not only effectively double-seal the intestinal contents, effectively divert the intestinal contents, ensure good healing of the anastomosis, but also achieve the fixation of the position of the catheter head end, and it will not shift forward or backward; in addition, by setting the guide part, the catheter can be made smoother during long-distance insertion, and the position of the catheter in the intestine can be accurately determined. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The accompanying drawings are used to provide further understanding of the present invention and constitute a part of the specification. They are used to explain the present invention together with the embodiments of the present invention and do not constitute a limitation of the present invention.

[0019] In the attached figure:

[0020] Figure 1 Schematic diagram of the structure of an embodiment of the present invention;

[0021] Figure 2 for Figure 1 A partial enlarged view of point A in the middle;

[0022] Figure 3 This is a schematic structural diagram of a fixing portion in an embodiment of the present invention;

[0023] Figure 4 This is another structural schematic diagram of the fixing portion in an embodiment of the present invention;

[0024] Figure 5 This is a schematic structural diagram of a supporting protective member in an embodiment of the present invention;

[0025] Figure 6 It is a schematic structural diagram of a fistula catheter in the prior art.

[0026] Labeled parts: 1-rectum, 101-anastomosis, 2-appendix, 3-fixation part, 31-first balloon, 32-second balloon, 33-protrusion, 4-ileocecal valve, 5-catheter, 51-excretion port, 52-inflation port, 53-drug administration and flushing port, 54-guidewire, 55-indicator light, 56-hole, 57-delivery tube, 58-trachea, 6-colon, 7-support and protection part. DETAILED DESCRIPTION

[0027] The preferred embodiments of the present invention are described below in conjunction with the accompanying drawings. It should be understood that the preferred embodiments described herein are only used to illustrate and explain the present invention and are not used to limit the present invention.

[0028] The present invention discloses a method for preventing anastomotic fistula after colorectal surgery, comprising the following steps:

[0029] Step 1: Preoperative preparation and partial resection of colorectal lesions and suturing of anastomosis;

[0030] Step 2: Install a degradable support and protection net through the mounting bracket to protect the anastomosis;

[0031] Step 3: The fixing portion of the catheter head end, which is adapted to the ileocecal valve structure, is introduced from the anus along the intestine to the ileocecal valve. The fixing portion is inflated so that it is stuck at the ileocecal valve. The fixing portion fixes the position of the catheter relative to the ileocecal valve, thereby achieving a double occlusion of the intestine and simultaneously draining the intestinal contents through the catheter.

[0032] Step 4: After the anastomosis is healed, the catheter is deflated and the catheter and the fixation part are removed from the ileocecal valve through the anus.

[0033] Step 5: Clean the anastomosis.

[0034] The present invention also discloses a device for preventing anastomotic fistula after colorectal surgery, such as Figure 1 As shown, it includes a catheter 5 introduced into the ileocecal valve 4 through the anus and intestine, as shown in FIG. Figure 2 As shown, an inflatable fixing portion 3 is provided near the head end of the catheter 5, which is adapted to the structure of the ileocecal valve 4 and fixed at the position of the ileocecal valve 4. The head end of the catheter 5 is provided with a hole 56 for drug administration, flushing and intestinal content discharge. The tail end of the catheter 5 is provided with an inflation port 52 and an excretion port 51. The inside of the catheter 5 is provided with a guide portion for the catheter 5 to pass through the intestine.

[0035] The beneficial effects of the present invention are as follows: the head end of the catheter 5 is provided with a fixing portion 3 of a double-balloon structure adapted to the structure of the ileocecal valve 4, the head end of the catheter 5 is introduced from the anus through the intestine, so that the fixing portion 3 is located at the position of the ileocecal valve 4, the fixing portion 3 of the double-balloon structure is inflated, and the fixing portion 3 of the double-balloon structure is stuck at the position of the ileocecal valve 4, so that the intestinal contents are effectively blocked to prevent leakage, and are discharged from the tail end of the catheter 5 through the excretion port 51. When the catheter 5 needs to be removed, the fixing portion 3 can be deflated and the catheter 5 can be pulled out from the intestine through the anus. On the one hand, except for the necessary surgical suturing of the anastomosis 101, no surgery is required on the human abdomen or other The invention can realize the fixation of the position of the first end of the catheter 5 and the prevention of forward or backward displacement of the catheter 5 by the guide portion 3. The invention can realize the fixation of the position of the first end of the catheter 5 and the prevention of forward or backward displacement of the catheter 5 by the guide portion 3. The invention can realize the fixation of the position of the first end of the catheter 5 and the prevention of forward or backward displacement of the catheter 5 by the guide portion 3. The invention can realize the fixation of the position of the first end of the catheter 5 and the prevention of forward or backward displacement of the catheter 5 by the guide portion 3. The invention can realize the fixation of the position of the first end of the catheter 5 and the prevention of forward or backward displacement of the catheter 5 by the guide portion 3.

[0036] As a preferred embodiment, Figure 3-4 As shown, the fixing portion 3 is a gourd-shaped or dumbbell-shaped structure, including a first balloon 31 and a second balloon 32 connected by a transition section. The catheter 5 passes through the transition section, the first balloon 31, and the second balloon 32. The first balloon 31 and the second balloon 32 are connected to the inflation port 52 via an air tube 58. The catheter 5 and the fixing portion 3 are made of silicone. Figure 1 The numbered portion 2 represents the rectum, the appendix 2 represents the appendix, the ileocecal valve 4 represents the ileocecal valve, and the colon 6 represents the colon. The fixed portion 3, which has a gourd-shaped or dumbbell-shaped structure, is smaller in the middle and larger at both ends. The middle portion fits snugly within the ileocecal valve 4, and the recessed portion prevents damage to the valve. The two balloons ensure positioning, preventing forward and backward displacement, and securing the catheter 5 within the intestine. The balloons, when inflated, adhere to the intestinal wall, effectively providing a double seal and diversion of the colon 6, preventing intestinal contents from leaking out of the anastomotic stoma 101 and affecting its healing.

[0037] As a preferred embodiment, the outer walls of the first and second balloons 31, 32 are configured with protrusions 33 that facilitate contact with the intestinal wall. The protrusions 33 provide a more secure and reliable contact between the outer walls of the first and second balloons 31, 32 and the intestinal wall at the ileocecal valve 4 after inflation, further preventing the balloons from shifting.

[0038] Furthermore, the tail end of the catheter 5 is provided with a drug administration flushing port 53, and the inflation port 52, the excretion port 51, and the drug administration flushing port 53 are all provided with a sealing cover connected to the catheter 5. The drug administration flushing port 53 and the excretion port 51 can be independently provided in the catheter 5 through a pipeline and connected to the hole 56 at the head end of the catheter 5, or they can be used together with one catheter 5. Specifically, for hygienic considerations, in the present invention, the drug administration flushing port 53 is connected to the hole 56 through a delivery tube 57, the catheter 5 is used for excretion and is connected to the excretion port 51, and the inflation port 52 is connected to the two balloons through an trachea 58 to facilitate inflation and exhaust. By providing a sealing cover, dust or other foreign matter can be prevented from entering the catheter 5, thereby ensuring the hygiene inside the catheter 5.

[0039] As a preferred embodiment, the guide portion includes a guide wire 54, an indicator light 55 and a camera. The guide wire 54 is arranged in the catheter 5, and the indicator light 55 and the camera are arranged at the head end of the guide wire 54 to accurately determine the position of the catheter 5 during use.

[0040] As a preferred embodiment, Figure 5 As shown, a support and protection member 7 is provided at the position of the anastomosis 101 of the colorectal 1. The support and protection member 7 is mounted on the outer side of the side wall of the catheter 5 through a mounting bracket. The support and protection member 7 is made of a biodegradable material. Specifically, the support and protection member 7 is woven from polyglycolic acid fiber. By providing the support and protection member 7, the anastomosis 101 can be effectively supported, which helps the healing of the anastomosis 101. The support and protection member 7 is made of a degradable material. As the anastomosis 101 heals, its material is completely degraded, and no secondary surgery is required to remove it, thereby avoiding secondary damage to the patient. The installation bracket includes an inserter. Before the support and protection parts are put into service, the support and protection parts and the inserter are both installed on the outside of the catheter. The length of the inserter is 5cm to 50cm. The support and protection parts can be delivered to the anastomosis position through the anus and then released to support the anastomosis to prevent the intestinal contraction at this position, which is conducive to wound healing. The inserter is then pulled out or removed. In order to facilitate the installation of the inserter and the support and protection net, the tail end of the catheter can be set to a split structure, which is convenient for the installation of the inserter and the support and protection net, and at the same time meets the actual requirements of different patients for the catheter length.

[0041] In summary, the present invention can prevent anastomotic fistula 101, facilitate wound healing in patients, and only requires surgical suture of the anastomotic stoma 101, without the need for surgical opening and suture of other parts. This reduces the physical trauma caused by the surgery to the patient, helps improve the patient's quality of life after surgery, and is applicable to the field of medical device technology.

[0042] Finally, it should be noted that the above descriptions are merely preferred embodiments of the present invention and are not intended to limit the present invention. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art will be able to modify the technical solutions described in the aforementioned embodiments or substitute equivalents for some of the technical features. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention shall be included within the scope of protection of the claims of the present invention.

Claims

1. A device for preventing anastomotic leakage after colorectal surgery, characterized in that: The invention comprises a catheter introduced through the anus and intestine to the ileocecal valve position, and an inflatable fixing portion is provided near the front end of the catheter, which is adapted to the ileocecal valve structure and fixed to the ileocecal valve position. The front end of the catheter is provided with a hole for drug administration, flushing and intestinal content discharge, the rear end of the catheter is provided with an inflation port and an excretion port, and the interior of the catheter is provided with a guide portion for the catheter to be used in the intestine. The fixing portion is a gourd-shaped or dumbbell-shaped structure, including a first balloon and a second balloon connected by a transition section. The catheter passes through the middle of the first balloon, the transition section, and the second balloon. The first and second balloons are connected to the inflation port through a trachea. The outer side walls of the first and second balloons are structured with protrusions that facilitate fitting to the intestinal wall. The tail end of the catheter is also provided with a drug administration and flushing port, and the inflation port, the excretion port, and the drug administration and flushing port are all provided with a sealing cover connected to the catheter; The guide part includes a guide wire, an indicator light and a camera. The guide wire is arranged in the catheter. The indicator light and the camera are arranged at the head end of the guide wire to accurately determine the position of the catheter during use. A support and protection piece is provided at the position of the colorectal anastomosis. The support and protection piece is sleeved on the outside of the catheter through the installation bracket and is located at the anastomosis of the intestinal inner wall.

2. The device for preventing anastomotic leakage after colorectal surgery according to claim 1, characterized in that: The supporting protection piece is made of biodegradable material.

3. The device for preventing anastomotic leakage after colorectal surgery according to claim 1, characterized in that: The catheter and the fixing part are made of silicone.

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