Flow guide fixing device for enteric cavity wall isolation

Abstract

The invention discloses a flow guide fixing device for enteric cavity wall isolation, and relates to the field of medical instruments. The tubular flow guide support is fixed through the strapping tape with the adjustable clamping degree, standardization of the strapping and fixing technique is achieved, and the strapping and fixing process of the intestinal canal and the cavity wall isolation flow guide process are more efficient, more convenient, safer and firmer. The ribbon body with a certain width is adopted to fix the tubular diversion stent, so that blood vessels are not prone to being excessively pressed or damaged, and the optimal physiological healing condition of intestinal canals can be completely met. The strapping tape and the tubular flow guide support are both made of medical degradable materials and can be absorbed or degraded by the human body after the intestinal canal anastomotic stoma is healed, and the tubular soft film sleeve can be discharged out of the human body along with degradation of the tubular flow guide support, so that the device does not have any residue in the human body, and the device does not need to be taken out again. According to the invention, enteric cavity wall expansion and cavity wall isolation diversion which meet the physiological healing condition of the intestinal canal can be safely and reliably carried out on the intestinal canal, and the fixation of the intestinal canal on the enteric cavity wall can be completed through convenient and standard operation.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical instruments, relates to anorectal surgical instruments, and particularly relates to a diversion fixing device for isolating an intestinal wall. 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. Anastomotic fistulas are a common complication in various colorectal anastomosis procedures, both those using hand suturing and tubular staplers, 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 must be re-anastomosed. If the intestinal anastomosis does not heal properly and fistulas develop, intestinal contents can leak into the abdominal cavity, potentially causing intraperitoneal or even systemic infection, leading to serious life-threatening complications or even death. Anastomotic fistulas not only increase the risk of complications and mortality, but also increase patient suffering and the medical burden. Therefore, isolation and protection of the intestinal anastomosis are essential.

[0003] Clinically, protective measures for intestinal anastomosis involve fixing the intestinal wall with an isolation device and expanding the drainage system. This is usually done with absorbable sutures, which are used to secure the intestinal tube to the isolation drainage device placed inside the intestinal cavity from the outside. However, the tightness of the ties is generally difficult to control, and the operating skills rely solely on experience, making it difficult to achieve scientific standardization. Because the sutures are very thin, if they are tied too tightly, they can easily exert excessive pressure on the blood vessels, causing compression or damage to the blood vessels, affecting blood circulation and hindering the physiological healing of the intestine. If the ties are too loose, they can easily become insufficiently secure, leading to displacement and failure of the isolation drainage device, which can even result in medical accidents.

[0004] Another technical implementation solution in clinical practice is to rely on the structure and material properties of the intestinal wall isolation and diversion device itself, and expand the intestinal tube in the natural stretch state of the diversion device in the intestinal cavity to perform intestinal wall isolation and diversion. Although this method avoids the problem of suture binding, since the intestine peristalsis intermittently and has a certain stretching force, if no artificial forced fixation method is adopted, the isolation and diversion device in the intestinal cavity still has a great risk of displacement and failure.

[0005] In summary, there is still no clinical solution for intestinal wall expansion fixation and intestinal wall isolation and diversion that meets the physiological healing conditions of the intestinal tract, is safe and reliable, and can be operated in a standardized manner, and its related medical devices are used to isolate and protect intestinal anastomosis to meet actual clinical needs. Summary of the Invention

[0006] The purpose of the present invention is to provide a diversion and fixation device for intestinal wall isolation, which can safely and reliably expand the intestinal wall and isolate and divert the intestinal wall in accordance with its physiological healing conditions, thereby achieving complete isolation of the intestinal anastomosis and preventing the occurrence of anastomotic fistula to the greatest extent. It can also complete its fixation in the intestinal cavity through convenient and standardized operations to solve the shortcomings of the above-mentioned existing clinical technologies.

[0007] To achieve the above-mentioned objectives, the present invention provides a diversion and fixing device for isolating the intestinal wall, comprising a tubular diversion stent, a tubular soft membrane sleeve and a binding band. The tubular diversion stent is used to be placed inside the intestinal cavity to expand the intestinal wall. The binding band is used to bind and fix the tubular diversion stent from the outside of the intestinal tract, and the tightness of the binding band is adjustable. The tubular soft membrane sleeve is connected to the tubular diversion stent to isolate the intestinal wall and divert intestinal contents to the outside of the anus.

[0008] In some embodiments, the strapping strap includes a strap body and a tension-adjusting lock buckle, the tension-adjusting lock buckle includes a lock adjustment frame and an adjustment block provided on the lock adjustment frame, the adjustment block can switch between a locked state and an unlocked state, the lock adjustment frame is provided at the first end of the strap body, and a channel for the second end of the strap body to shuttle through is formed between the lock adjustment frame and the adjustment block; the first locking structure is provided on the side of the adjustment block facing the channel, and the outer side surface of the second end of the strap body is provided with a plurality of second locking structures that are locked and matched with the first locking structure along its length direction, when the adjustment block is in the unlocked state, the second end of the strap body can shuttle and adjust in the channel, and when the adjustment block is in the locked state, the second end of the strap body is locked in the channel by the adjustment block.

[0009] In some embodiments, the adjustment block is a wedge-shaped adjustment block, the large head end of the wedge adjustment block is movably mounted on the lock adjustment frame by a torsion spring, the small head end of the wedge adjustment block points in a direction away from the first end of the belt body, and the first locking structure is provided at the large head end of the wedge adjustment block; pressing the small head end of the wedge adjustment block can switch the large head end of the wedge adjustment block to the unlocked state, and releasing the small head end of the wedge adjustment block can switch the large head end of the wedge adjustment block to the locked state under the resetting action of the torsion spring elastic force.

[0010] In some embodiments, the wedge-shaped adjustment block and the lock adjustment frame are integrally formed.

[0011] In some embodiments, one of the first locking structure and the second locking structure is a serrated protrusion, and the other is a serrated groove.

[0012] In some embodiments, the strapping belt further includes a fixing frame and a marking line, both of which are arranged on the outer side of the belt body. The fixing frame can tighten the second end of the belt body, and the marking line is used to indicate the tightness of the belt body.

[0013] In some embodiments, the intestinal tract contact surface of the belt body is provided with an anti-slip structure; the intestinal tract contact surface is the opposite surface of the outer surface.

[0014] In some embodiments, the tubular diversion stent and the binding tape are both made of medical absorbable polymer materials; the tubular soft film sleeve is a soft plastic film sleeve or a degradable soft film sleeve, and the viscosity of the tubular soft film sleeve is 700000 mPa·s and the density is 1.11 g / cm 3 , hardness is 30A, tensile strength is 4MPa, tear strength is 13KN / m, and elongation at break is 550%.

[0015] In some embodiments, the tubular diversion stent includes an intermediate tube section and support tube sections located at both ends of the intermediate tube section. The outer diameters of the two support tube sections are the same and coaxial. The outer diameter of the support tube section is larger than the outer diameter of the intermediate tube section, and the intermediate tube section and the support tube sections at both ends are connected through a smooth conical surface; the support tube section is used to expand the intestinal wall, and the intermediate tube section is used for being tied and fixed by the strapping belt.

[0016] In some embodiments, the middle pipe section and the two supporting pipe sections are coaxial, the smooth conical surface is a frustum side, and the small end of the frustum side is connected to the middle pipe section, and the large end of the frustum side is connected to the supporting pipe section.

[0017] In some embodiments, the tubular flow-guiding support is an integrally formed part.

[0018] In some embodiments, the tubular soft film sleeve is sleeved over the outside of one end of the tubular diversion bracket and is bonded and fixed to the outer wall of the tubular diversion bracket; or, the tubular soft film sleeve is sleeved over the inside of one end of the tubular diversion bracket and is bonded and fixed to the inner wall of the tubular diversion bracket; or, the tubular soft film sleeve is sleeved over the outside of one end of the tubular diversion bracket and is tied and fixed to the tubular diversion bracket by the binding belt.

[0019] In some embodiments, the wall of the tubular flow-guiding support is closed; or, the wall of the tubular flow-guiding support is provided with a hollow structure.

[0020] Compared with the prior art, the present invention has achieved the following technical effects.

[0021] The diversion and fixation device for intestinal wall isolation proposed in the present invention can not only safely and reliably dilate the intestinal wall in accordance with its physiological healing conditions and isolate and divert the intestinal wall, thereby completely isolating the intestinal anastomosis and preventing the occurrence of anastomotic fistula to the greatest extent, but also complete its fixation in the intestinal cavity through convenient and standardized operation, thus addressing the shortcomings of existing clinical technologies. The specific beneficial effects are as follows:

[0022] (1) The tubular guide bracket is fixed with a strapping belt with adjustable tightness, which realizes the standardization of the strapping and fixing technique and shortens the learning curve.

[0023] (2) Using a binding belt to fix the tubular diversion stent can make the binding, fixing, isolation and diversion process of the intestinal tube more efficient, convenient, safe and firm.

[0024] (3) The tubular diversion stent is fixed with a binding belt of a certain width, which exerts less pressure on the blood vessels and is less likely to cause excessive compression or damage to the blood vessels. It can ensure smooth blood supply and fully meet the optimal physiological healing conditions of the intestinal tract.

[0025] (4) Both the binding band and the tubular diversion stent are made of medical degradable materials. After the intestinal anastomosis is healed, they can be absorbed or degraded by the human body. The tubular soft membrane sleeve can be excreted from the body along with the degradation of the tubular diversion stent, leaving no residue in the human body and eliminating the need to remove the device again.

[0026] (5) The strapping tape is equipped with a fixing frame and a marking line. The fixing frame is used to tighten and secure the remaining strapping section after the strapping is completed, preventing it from warping outward and damaging the intestine and surrounding tissues. The relative position of the fixing frame or marking line and the top of the remaining strapping section after the strapping can be used as a reference standard for determining the appropriate tightness for strapping different intestinal diameters, improving ease of use. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] 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.

[0028] Figure 1 This is a schematic diagram of the overall structure of a diversion and fixing device for isolating the intestinal wall disclosed in an embodiment of the present invention.

[0029] Figure 2 This is a schematic structural diagram of a strapping belt disclosed in an embodiment of the present invention.

[0030] Figure 3 for Figure 2 Schematic top view of .

[0031] Figure 4 for Figure 2 Schematic diagram of the top view.

[0032] Figure 5 This is a schematic structural diagram of a tubular flow-guiding support disclosed in an embodiment of the present invention.

[0033] Figure 6 This is a schematic structural diagram of a tubular soft film sleeve disclosed in an embodiment of the present invention.

[0034] Figure 7 This is a schematic diagram of the fixing structure of the tubular flow guide bracket by the binding belt disclosed in an embodiment of the present invention.

[0035] Figure 8 Schematic diagram of the structure of placing a tubular diversion stent into the proximal end of the severed intestinal wall.

[0036] Figure 9 This is a structural diagram in which one end of the suture is tied to the end of the tubular soft membrane sleeve, and the other end is tied to the head end of the tubular anastomosis device stapler or the head end of the clamp.

[0037] Figure 10 This is a schematic diagram of the structure after the severed intestinal ends are anastomosed through the anus using a tubular anastomosis device.

[0038] Figure 11 This is a schematic diagram of the structure in which the end of the tubular soft membrane sleeve is pulled out of the anus through the anus end of the tubular anastomosis device or the clamp end.

[0039] Figure 12 This is a schematic diagram of a state where the diversion and fixation device for isolating the intestinal wall disclosed in an embodiment of the present invention is placed in the body.

[0040] In the figure, the reference numerals are: 100-a diversion fixing device for isolating the intestinal wall; 200-a tubular anastomosis nail seat head end or a clamp head end; 1-a tubular diversion bracket; 11-an intermediate pipe section; 12-a supporting pipe section; 13-a smooth conical surface; 2-a tubular soft film sleeve; 3-a strapping belt; 31-a belt body; 311-a first end; 312-a second end; 32-a tension adjustment lock; 321-a lock adjustment frame; 322-an adjustment block; 33-a first locking structure; 34-a second locking structure; 35-a fixing frame; 36-a marking line; 37-an anti-slip structure; 4-an intestinal cavity; 5-an intestinal tube; 6-an intestinal wall; 7-an intestinal contents; 8-an intestinal anastomosis; 9-an intestinal tube end; 10-a suture. DETAILED DESCRIPTION

[0041] 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.

[0042] The purpose of the present invention is to provide a diversion and fixation device for intestinal wall isolation, which can safely and reliably expand the intestinal wall and isolate and divert the intestinal wall in accordance with its physiological healing conditions, thereby achieving complete isolation of the intestinal anastomosis and preventing the occurrence of anastomotic fistula to the greatest extent. It can also complete its fixation in the intestinal cavity through convenient and standardized operations to solve the shortcomings of existing clinical technologies.

[0043] 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.

[0044] like Figures 1 to 7 As shown, this embodiment provides a diversion and fixing device 100 for isolating the intestinal wall, comprising a tubular diversion stent 1, a tubular soft membrane sleeve 2 and a binding band 3. The tubular diversion stent 1 is used to be placed inside the intestinal cavity 4 to expand the intestinal cavity wall (here and below, "intestinal cavity wall" refers to the inner wall of the intestinal cavity 4). The binding band 3 is used to bind and fix the tubular diversion stent 1 from the outside of the intestinal tube 5, and the tightness of the binding band 3 is adjustable; the tubular soft membrane sleeve 2 is connected to the tubular diversion stent 1 to isolate the intestinal cavity wall and divert the intestinal contents 7 to the outside of the anus. The length of the tubular soft membrane sleeve 2 can extend outside the anus. When in use, the binding band 3 is mainly used to fix the tubular diversion stent 1 at a proximal end position in the intestinal cavity 4 suitable for the intestinal anastomosis. The binding band 3 adopts a binding tightness adjustable structure, and the tubular diversion stent 1 can be fixed in the intestinal cavity 4 through convenient and standardized operations, avoiding the uncertainty and irregularity of suture binding.

[0045] Some feasible implementations, such as Figures 2 to 4When the buckle 321 is in the unlocked state, the second end 312 of the strap 31 can be adjusted by the buckle 321 and the buckle 322 is in the unlocked state. It should be emphasized that the outer side is the side of the band body 31 opposite to the intestinal contact surface. The rational structure of the strap 3 and the ingenious design of the tension adjustment buckle 32 make the strap 3 more convenient, efficient and flexible in clinical operation.

[0046] In some feasible embodiments, the entrance direction of the lock adjustment frame 321 is preferably horizontal to the outer side surface of the belt body 31, so that the second end 312 of the belt body 31 can pass through smoothly, and at the same time, the second end 312 of the belt body 31 can be made to fit and overlap with the first end 311 of the belt body 31 as much as possible, so as to avoid the second end 312 of the belt body 31 bulging outward, occupying the abdominal cavity space or causing damage to the adjacent intestinal tract 5.

[0047] In some feasible embodiments, the adjustment block 322 is a wedge-shaped adjustment block 322, and the large end of the wedge-shaped adjustment block 322 can be movably mounted on the lock adjustment frame 321 through a torsion spring, and the small end of the wedge-shaped adjustment block 322 points in the direction away from the first end 311 of the belt body 31, and the first locking structure 33 is provided at the large end of the wedge-shaped adjustment block 322; pressing the small end of the wedge-shaped adjustment block 322 can switch the large end of the wedge-shaped adjustment block 322 to an unlocked state, and loosening the small end of the wedge-shaped adjustment block 322, the large end of the wedge-shaped adjustment block 322 can switch to a locked state under the resetting action of the torsion spring elastic force to compress the belt body 31. In some other embodiments, in order to reduce production costs and processing difficulty, the wedge-shaped adjustment block 322, the lock adjustment frame 321 and the belt body 31 can also be integrally formed with a biodegradable plastic material. By pressing the wedge-shaped adjustment block 322, the elasticity of the plastic can be used to adjust the tightness of the wedge-shaped adjustment block 322 on the belt body 31, so that the adjustment block 322 can be switched between a locked state and an unlocked state, thereby achieving tightness adjustment of the belt body 31.

[0048] In some feasible implementations, one of the first locking structure 33 and the second locking structure 34 is a sawtooth protrusion, and the other is a sawtooth groove adapted to the sawtooth protrusion. Figure 2 and Figure 4 As shown, the large end of the wedge-shaped adjustment block 322 is preferably provided with 2 to 4 continuous serrated protrusions; correspondingly, the outer side surface of the second end 312 of the belt body 31 is continuously provided with multiple serrated grooves along its length direction, which can expand the adjustment range of the tightness of the strapping belt 3.

[0049] Some feasible implementations, such as Figure 3 and Figure 4 As shown, the strapping belt 3 also includes a fixing frame 35 and a marking line 36, both of which are arranged on the outer side of the belt body 31. When tying the intestinal tube 5, the second end 312 of the belt body 31 can overlap with the entire belt body 31 after passing through the tension adjustment lock 32. After adjusting the tightness of the belt body 31, the second end 312 of the belt body 31 is locked by the tension adjustment lock 32. After that, the end of the second end 312 of the belt body 31 can pass through the fixing frame 35. The fixing frame 35 plays the role of tightening the second end 312 of the belt body 31. The marking line 36 is arranged near the fixing frame 35, and as shown in FIG. Figure 3 As shown, the marking line 36 is located between the second locking structure 34 and the fixed frame 35. The end of the fixed frame 35 or the marking line 36 can be used to indicate the current tightness of the belt body 31. The fixed frame 35 is set to protrude from the belt body 31, and the setting form of the marking line 36 includes but is not limited to convex dots, pits or flat printed lines. Taking the marking line 36 as an example, the marking convex dots can be set to protrude from the surface of the belt body 31, or protrude on both sides of the width of the belt body 31, such as Figure 3 , which is a schematic structural diagram of the marking protrusions protruding on both sides of the width of the belt body 31.

[0050] In some feasible embodiments, the intestinal contact surface of the belt body 31 is provided with an anti-slip structure 37 to prevent the belt body 31 and the intestinal 5 from sliding and shifting, thereby improving the reliability of the belt body 31 fixing the tubular diversion stent 1. The aforementioned intestinal contact surface is the opposite surface of the aforementioned outer surface. The anti-slip structure 37 may be provided in the form of a pit or a protrusion. As a preferred embodiment, the anti-slip structure 37 is preferably a protrusion structure protruding from the intestinal contact surface, and the protrusion structure is preferably a dot-shaped protrusion array, a strip-shaped protrusion array or an anti-slip rack, such as Figure 2 and Figure 4 As shown, the preferred protruding structure is an anti-slip rack arranged along the length direction of the belt body 31 , and the surface of the anti-slip rack is rounded and smooth to avoid damaging the outer wall of the intestinal cavity 4 .

[0051] In some feasible implementations, each structural component of the strapping belt 3 has a smooth and rounded surface, and does not pose a risk of damaging the surrounding intestinal tissues.

[0052] In some feasible embodiments, both the tubular stent 1 and the strapping band 3 are preferably made of a medically absorbable polymer material. This eliminates the need for a second surgery to remove the tubular stent 1 and strapping band 3. Compared to currently used intestinal wall isolation and diversion devices that require removal after the intestinal anastomosis has healed, this can avoid a second surgery, saving medical resources and reducing patient pain and medical burdens. Medically absorbable polymer materials that can be used for the strapping band 3 include, but are not limited to, polydioxanone (PPDO); medically absorbable polymer materials that can be used for the tubular stent 1 include, but are not limited to, polyglycolide (PGA).

[0053] In some feasible implementations, the tubular soft film sleeve 2 is a non-degradable and absorbable soft plastic film sleeve or a degradable soft film sleeve. Considering that the tubular soft film sleeve 2 has high softness requirements and thin wall thickness, it needs to be folded and stretched many times during use, so the use of degradable and absorbable materials cannot meet the structural strength requirements of the tubular soft film sleeve 2. Therefore, this solution prefers that the tubular soft film sleeve 2 adopts a non-degradable and absorbable soft plastic film sleeve. The material of the soft plastic film sleeve includes but is not limited to silicone, latex, TPU (thermoplastic polyurethane rubber), Teflon, etc. The material selection and process of the tubular soft film sleeve 2 generally meet the following parameters: viscosity 700000mPa·s, density 1.11g / cm 3 , hardness 30A, tensile strength 4MPa, tear strength 13KN / m, elongation at break 550%.

[0054] Since the tubular diversion stent 1 and the binding band 3 are both made of medical absorbable polymer materials, after the intestinal anastomosis heals, the tubular diversion stent 1 and the binding band 3 will degrade, and the tubular soft film sleeve 2 can also be directly pulled from the anorectal area or discharged naturally. Therefore, the entire device can be completely discharged from the body by itself without the need for a second surgery to remove it.

[0055] Some feasible implementations, such as Figure 1 and Figure 5 As shown, the tubular flow-diverting stent 1 includes an intermediate tube section 11 and support tube sections 12 located at both ends of the intermediate tube section 11. The support tube section 12 and the intermediate tube section 11 are preferably cylindrical tube sections. The two support tube sections 12 have the same outer diameter and are coaxial. The outer diameter of the support tube section 12 is larger than the outer diameter of the intermediate tube section 11, and the intermediate tube section 11 is connected to the support tube sections 12 at both ends via smooth tapered surfaces 13. The support tube sections 12 are used to expand the intestinal wall, and the intermediate tube section 11 is used for being tied and fixed by a binding band 3. The tubular flow-diverting stent 1 adopts a structure with a thin middle and thick ends. While ensuring reliable expansion of the intestinal wall, the tubular flow-diverting stent 1 can be fixed by the intermediate tube section 11 at the middle reduced diameter position. The binding band 3 is tied to the intermediate tube section 11 to prevent the binding band 3 from slipping relative to the tubular flow-diverting stent 1, which can further improve the fixing effect of the tubular flow-diverting stent 1.

[0056] In some feasible implementations, the middle pipe section 11 and the two supporting pipe sections 12 are coaxial.

[0057] In some feasible embodiments, the smooth conical surface 13 can be a frustum side or a tapered convex arc surface. As a preferred embodiment, the smooth conical surface 13 is a frustum side, and the diameter of the small end of the frustum side is equal to the outer diameter of the middle pipe section 11, the small end of the frustum side is connected to the middle pipe section 11, and the diameter of the large end of the frustum side is equal to the outer diameter of the support pipe section 12, the large end of the frustum side is connected to the support pipe section 12.

[0058] In some feasible implementations, the two supporting pipe sections 12 are symmetrically arranged with the middle pipe section 11 as the center; correspondingly, the two smooth conical surfaces 13 have exactly the same structure and are symmetrically arranged with the middle pipe section 11 as the center.

[0059] In some feasible implementations, the tubular flow-guiding support 1 is preferably an integrally formed part.

[0060] In some feasible embodiments, the tubular soft membrane sleeve 2 is preferably placed on the outside of one end of the tubular diversion stent 1 (i.e., the end of the tubular diversion stent 1 away from the proximal end of the intestinal tract) and is bonded and fixed to the outer wall of the tubular diversion stent 1 using glue or other adhesive. The tubular diversion stent 1 mainly serves to connect and open the tubular soft membrane sleeve 2. The tubular diversion stent 1 and the tubular soft membrane sleeve 2 are bonded together, providing a good seal and preventing leakage of intestinal contents 7. In addition, the tubular soft membrane sleeve 2 can also be placed on the inside of one end of the tubular diversion stent 1 (i.e., the end of the tubular diversion stent 1 away from the proximal end of the intestinal tract), and the outer wall of the tubular soft membrane sleeve 2 is bonded and fixed to the inner wall of the tubular diversion stent 1. Alternatively, the tubular soft membrane sleeve 2 can also be placed only on the outside of one end of the tubular diversion stent 1, but not bonded and fixed to the tubular diversion stent 1, and can be tied and fixed to the tubular diversion stent 1 by the tightening action of the binding band 3. The preferred solution is to have the tubular soft membrane sleeve 2 be sleeved over the outside of the tubular diversion stent 1 and bonded and fixed to the outer wall of the tubular diversion stent 1. Before the diversion fixing device 100 for isolating the intestinal wall is placed in the intestinal cavity 4, the tubular soft membrane sleeve 2 has been bonded and fixed to the tubular diversion stent 1 as a whole.

[0061] In some feasible implementations, the tubular diversion stent 1 mainly plays the role of supporting and expanding the intestinal wall. The wall of the tubular diversion stent 1 can be set as follows: Figure 5The closed tube wall shown can also be provided with a hollow structure on the tube wall of the tubular diversion stent 1 without affecting the supporting strength of the tubular diversion stent 1, which can make the tubular diversion stent 1 lighter and have lower manufacturing costs. Under normal use, the tubular diversion stent 1 generally fits against the intestinal wall to support the intestinal wall. When providing the hollow structure, it is necessary to consider whether there is leakage in the gap between the tubular diversion stent 1 and the intestinal wall. In order to enhance the support and diversion function of the tubular diversion stent 1 and avoid unnecessary leakage between the tubular diversion stent 1 and the intestinal wall, it is preferred to provide the hollow structure only at the distal end of the tubular diversion stent 1 near the intestinal anastomosis (i.e., the end of the tubular diversion stent 1 that is connected to the tubular soft film sleeve 2). The side walls of the remaining positions of the tubular diversion stent 1 adopt a closed design. After the tubular diversion stent 1 and the tubular soft film sleeve 2 are connected and fixed, the hollow structure is covered by the tubular soft film sleeve 2. This design makes the tubular diversion stent 1 have the advantages of both lightness and leakage prevention. There is no limit to the setting form of the hollow structure, and structures such as grid hollowing can be used. The specific structure can be flexibly adjusted according to processing and usage requirements.

[0062] The following describes in detail the method of using the diversion and fixing device 100 for isolating the intestinal wall in combination with the above structural design. Figures 8 to 11 As shown:

[0063] Step 1: After the intestinal tube 5 is cut, the inner diameter of the intestinal tube 5 is measured first, and a suitable specification and model of the tubular diversion stent 1 with an outer diameter (ie, the outer diameter of the support tube section 12 ) larger than the inner diameter of the intestinal tube 5 is selected.

[0064] Step 2: Place the upper end of the tubular diversion stent 1 into the proximal end of the intestinal cavity about 50 mm away from the severed end to support the intestinal wall. Use the binding band 3 to fix the tubular diversion stent 1 in the intestinal cavity 4 from the outside of the intestinal tube 5. When using a large-sized tubular diversion stent 1 (i.e., the outer diameter of the supporting tube section 12 is larger), the remaining section of the binding band after binding can be inserted into the fixing frame 35, and the tightness of the entire binding band 3 is preferably such that the top of the remaining section of the binding band (i.e., the end of the second end 312) does not protrude outside the fixing frame 35; when using a small-sized tubular diversion stent 1 (i.e., the outer diameter of the supporting tube section 12 is smaller), after the remaining section of the binding band passes through the fixing frame 35, the tightness of the entire binding band 3 is preferably such that the top of the remaining section of the binding band (i.e., the end of the second end 312) is exposed outside the fixing frame 35 and is flush with the tail end of the marking line 36.

[0065] Step 3: After the severed intestinal tube 5 is anastomosed, in order to directly pull the tubular pecten 2 out of the anus with the help of the tubular stapler, one end of the tubular pecten 2 can be tied with a surgical suture 10, and the other end can be tied with the anus end of the tubular stapler or the clamp head 200; it is also possible not to use the surgical suture 10 for pre-tying and pulling.

[0066] Step 4: Figure 10As shown, the tubular soft membrane sleeve 2 is curled and folded and placed in the proximal severed intestinal cavity. The proximal intestinal tube is pulled close to the distal severed intestinal tube, and the two severed intestinal ends 9 are anastomosed through the anus with a tubular anastomosis device to form an intestinal anastomosis 8.

[0067] Step 5: After the intestinal anastomosis, the end of the tubular pia mater 2 is pulled out of the anus using the anvil or clamp on the head of the tubular stapler, and the surgical suture 10 is removed. Alternatively, if the tubular stapler and the surgical suture 10 were not used in the early stage, the end of the tubular pia mater 2 can be directly pulled out of the anus using surgical oval forceps.

[0068] Step 6: Suture the abdominal incision and complete the operation.

[0069] After the above steps 1 to 6, the state of the diversion fixation device 100 for isolating the intestinal wall is placed in the body is as follows Figure 12 shown.

[0070] In summary, the diversion and fixation device 100 for intestinal wall isolation proposed in this solution includes a special intestinal tract binding band that can be degraded and absorbed by the human body and has adjustable tightness, a degradable medical absorbable polymer tubular diversion stent, and a tubular soft plastic film sleeve of appropriate length. The degradable tubular diversion stent that has been placed in the intestinal cavity is tied and fixed with the absorbable binding band at a position in the intestinal cavity proximal to the intestinal anastomosis, which plays the role of stretching the intestinal wall and guiding the intestinal contents to completely enter the tubular soft plastic film sleeve, completely isolating the intestinal anastomosis. The tubular soft plastic film sleeve can be pulled out of the anus through the rectum by an instrument for the excretion of intestinal contents. The above-mentioned diversion and fixation device is convenient and standardized to operate, and can safely and reliably expand the intestinal wall and isolate and divert the intestinal wall in accordance with its physiological healing conditions, thereby achieving complete isolation of the intestinal anastomosis, thereby preventing the occurrence of anastomotic fistula to the greatest extent.

[0071] Compared with the use of absorbable sutures to bind and fix the intestinal tube for isolation and diversion, the diversion and fixation device 100 for intestinal wall isolation proposed in this solution achieves the standardization of binding and fixation techniques and shortens the learning curve.

[0072] The diversion and fixation device 100 for intestinal wall isolation proposed in this solution can make the process of bundling, fixing, isolating and diverting the intestinal tube more efficient, convenient, safe and firm compared with the use of absorbable sutures to bind, fix and isolate the intestinal tube.

[0073] Compared with the use of absorbable sutures to tie and fix the intestine for isolation and diversion, the diversion and fixation device 100 for intestinal wall isolation proposed in this solution uses a tie body with a certain width, which exerts less pressure on the blood vessels and is less likely to cause excessive compression or damage to the blood vessels. It can ensure smooth blood supply and fully meet the optimal physiological healing conditions of the intestine.

[0074] The diversion and fixation device 100 for intestinal wall isolation proposed in this solution is made of medically degradable materials, because the binding band and the tubular diversion stent are both made of medically degradable materials. After the intestinal anastomosis is healed, they can be absorbed or degraded by the human body. The tubular soft plastic film sleeve can be excreted from the body as the tubular diversion stent degrades, leaving no residue in the human body and eliminating the need to remove the device again.

[0075] This proposed device 100 for intestinal wall isolation features a binding band with a fixing frame and a marking line. The fixing frame is used to secure the remaining portion of the binding band after binding, preventing it from warping and damaging the intestine and surrounding tissues. Furthermore, the relative position of the fixing frame or marking line and the top of the remaining portion of the binding band can be used as a reference for determining the appropriate tightness for binding different intestinal diameters, improving ease of use.

[0076] It should be noted that the structures, proportions, sizes, etc. depicted in the drawings of this specification are only used to match the contents disclosed in the specification for people familiar with this technology to understand and read, and are not used to limit the conditions for the implementation of the present invention. Therefore, they have no substantial technical significance. Any modification of the structure, change in the proportional relationship or adjustment of the size should still fall within the scope of the technical content disclosed by the present invention without affecting the efficacy and purpose of the present invention. At the same time, the terms such as "upper", "lower", "left", "right", "middle" and "one" quoted in this specification are only for the convenience of description and are not used to limit the scope of the implementation of the present invention. Changes or adjustments in their relative relationships should also be regarded as the scope of the implementation of the present invention without substantially changing the technical content.

[0077] 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 diversion and fixing device for isolating the intestinal wall, characterized in that: The invention comprises a tubular diversion stent (1), a tubular soft membrane sleeve (2) and a binding belt (3), wherein the tubular diversion stent (1) is used to be built into the intestinal cavity (4) to expand the intestinal cavity wall, and the binding belt (3) is used to bind and fix the tubular diversion stent (1) from the outside of the intestinal tube (5), and the degree of tightening of the binding belt (3) is adjustable; The tubular soft membrane sleeve (2) is in communication with the tubular diversion support (1) to isolate the intestinal cavity wall and divert intestinal contents to the outside of the anus.

2. The diversion and fixing device for isolating the intestinal wall according to claim 1, characterized in that: The strapping belt (3) comprises a belt body (31) and a tension adjustment lock (32); the tension adjustment lock (32) comprises a lock adjustment frame (321) and an adjustment block (322) arranged on the lock adjustment frame (321); the adjustment block (322) can switch between a locked state and an unlocked state; the lock adjustment frame (321) is arranged at a first end (311) of the belt body (31); a passage is formed between the lock adjustment frame (321) and the adjustment block (322) for the second end (312) of the belt body (31) to pass through; the adjustment block A first locking structure (33) is provided on the side of (322) facing the channel, and a plurality of second locking structures (34) that are locked with the first locking structure (33) are provided on the outer side surface of the second end (312) of the belt body (31) along its length direction. When the adjustment block (322) is in the unlocked state, the second end (312) of the belt body (31) can be adjusted to shuttle in the channel. When the adjustment block (322) is in the locked state, the second end (312) of the belt body (31) is locked in the channel by the adjustment block (322).

3. The diversion and fixing device for isolating the intestinal wall according to claim 2, characterized in that: The adjusting block (322) is a wedge-shaped adjusting block (322), the large end of the wedge-shaped adjusting block (322) is movably mounted on the lock adjusting frame (321) through a torsion spring, the small end of the wedge-shaped adjusting block (322) points in a direction away from the first end (311) of the belt body (31), and the first locking structure (33) is provided at the large end of the wedge-shaped adjusting block (322); pressing the small end of the wedge-shaped adjusting block (322) can switch the large end of the wedge-shaped adjusting block (322) to the unlocked state, and releasing the small end of the wedge-shaped adjusting block (322) allows the large end of the wedge-shaped adjusting block (322) to switch to the locked state under the resetting action of the torsion spring; or, the wedge-shaped adjusting block (322) and the lock adjusting frame (321) are integrally formed.

4. The diversion and fixing device for isolating the intestinal wall according to claim 2, characterized in that: One of the first locking structure (33) and the second locking structure (34) is a sawtooth protrusion, and the other is a sawtooth groove.

5. The diversion and fixing device for isolating the intestinal wall according to claim 2, characterized in that: The strapping belt (3) further comprises a fixing frame (35) and a marking line (36), wherein the fixing frame (35) and the marking line (36) are both arranged on the outer side of the strap body (31); the fixing frame (35) is capable of constricting the second end (312) of the strap body (31); and the marking line (36) is used to indicate the tightness of the strap body (31).

6. The diversion and fixing device for isolating the intestinal wall according to claim 2, characterized in that: The intestinal tract contact surface of the belt body (31) is provided with an anti-slip structure (37); the intestinal tract contact surface is the opposite surface of the outer side surface.

7. The diversion and fixing device for isolating the intestinal wall according to any one of claims 1 to 6, characterized in that: The tubular flow-guiding stent (1) and the binding belt (3) are both made of medical absorbable polymer materials; the tubular soft film sleeve (2) is a soft plastic film sleeve or a degradable soft film sleeve, and the viscosity of the tubular soft film sleeve (2) is 700,000 mPa·s and the density is 1.11 g / cm 3 , hardness is 30A, tensile strength is 4MPa, tear strength is 13KN / m, and elongation at break is 550%.

8. The diversion and fixing device for isolating the intestinal wall according to any one of claims 1 to 6, characterized in that: The tubular flow-guiding stent (1) comprises an intermediate pipe section (11) and supporting pipe sections (12) located at both ends of the intermediate pipe section (11); the two supporting pipe sections (12) have the same outer diameter and are coaxial; the outer diameter of the supporting pipe section (12) is larger than the outer diameter of the intermediate pipe section (11); and the intermediate pipe section (11) and the supporting pipe sections (12) at both ends are connected via smooth conical surfaces (13); the supporting pipe section (12) is used to expand the intestinal wall, and the intermediate pipe section (11) is used to be tied and fixed by the tying belt (3).

9. The diversion and fixing device for isolating the intestinal wall according to any one of claims 1 to 6, characterized in that: The tubular soft film sleeve (2) is sleeved on the outside of one end of the tubular flow guide bracket (1) and is bonded and fixed to the outer wall of the tubular flow guide bracket (1); or, the tubular soft film sleeve (2) is sleeved on the inside of one end of the tubular flow guide bracket (1) and is bonded and fixed to the inner wall of the tubular flow guide bracket (1); or, the tubular soft film sleeve (2) is sleeved on the outside of one end of the tubular flow guide bracket (1) and is tied and fixed to the tubular flow guide bracket (1) by the binding belt (3).

10. The diversion and fixing device for isolating the intestinal wall according to any one of claims 1 to 6, characterized in that: The tube wall of the tubular flow-guiding support (1) is closed; or, the tube wall of the tubular flow-guiding support (1) is provided with a hollow structure.

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