Rectum balloon funnel support

By designing a rectal balloon funnel stent, the problem of poor anal canal drainage effect is solved, achieving better fecal drainage and support, reducing surgical difficulty, adapting to different rectal shapes, reducing the need for multiple models, and making it suitable for long-term use.

CN223615174UActive Publication Date: 2025-12-02SHENSHAN MEDICAL CENT MEMORIAL HOSPITAL OF SUN YAT-SEN UNIV
View PDF 0 Cites 0 Cited by

Patent Information

Application Number
CN202422660260.3
Authority / Receiving Office
CN · China
Patent Type
Utility models(China)
Current Assignee / Owner
Filing Date
2024-10-31
Publication Date
2025-12-02
Estimated Expiration
2034-10-31

AI Technical Summary

Technical Problem

In existing technologies, the conventional insertion of an anal tube to drain feces to avoid contamination of the rectal anastomosis results in poor sealing and drainage, leading to unsatisfactory postoperative outcomes.

Method used

A rectal balloon funnel stent is designed, comprising a stent funnel, a stent body, a balloon, and an inflation assembly. The balloon has a ring structure, the stent funnel has a funnel structure, and the stent body has a cylindrical structure. The internal and external pressure of the balloon is controlled by the inflation assembly, and the design of the support ring and limiting protrusion improves stability and sealing.

Benefits of technology

It achieves better fecal drainage and support, reduces patient discomfort, lowers the difficulty and complexity of surgery, adapts to different rectal shapes, reduces the need for multiple models, and is suitable for long-term carrying.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN223615174U_ABST
    Figure CN223615174U_ABST
Patent Text Reader

Abstract

The utility model provides a rectum sacculus funnel support which is used for draining excrement and comprises a support funnel, a support body, a sacculus and an inflation assembly, the support funnel is communicated with the support body, the sacculus is communicated with the inflation assembly, the sacculus is of an annular structure, the support funnel is of a funnel structure, and the support body is of a straight cylinder structure. The stent funnel is at least provided with an abutting portion with the outer diameter larger than the inner diameter of the balloon, the outer diameter of the stent body is smaller than the inner diameter of the balloon, after the balloon is inflated by the inflation assembly, the stent body penetrates through the balloon and then is located below the balloon, and the balloon abuts against the abutting portion to support the stent funnel. Due to the fact that the support funnel is in the funnel shape and is provided with a large flaring, when the support funnel is placed in the rectum, excrement can be better received, the drainage effect is good, in addition, the support funnel is supported through inflation of the balloon, and the support funnel has good supporting performance and sealing performance.
Need to check novelty before this filing date? Find Prior Art

Description

Technical Field

[0001] This utility model relates to the field of medical device technology, and in particular to a rectal balloon funnel stent. Background Technology

[0002] Rectal cancer is a common surgical procedure in general surgery. In low rectal cancer (rectal cancer within 7cm of the anus), after resection of the rectal segment, the rectal anastomosis is often close to the anal verge, resulting in poor blood supply and a significantly increased incidence of anastomotic leakage. Currently, to avoid anastomotic leakage in low rectal cancer surgery, prophylactic terminal ileostomy is often used. This procedure requires maintaining the ileostomy for 3-6 months, followed by ileostomy reduction to restore normal bowel function, causing inconvenience to the patient's daily life, physical health, and finances. The purpose of a terminal ileostomy is primarily to divert feces, preventing contamination of the rectal anastomosis and allowing sufficient time for recovery. If a terminal ileostomy is not performed, a rectal tube is routinely inserted to drain feces and prevent contamination of the rectal anastomosis. However, the sealing and drainage effects of rectal tubes are often poor, resulting in unsatisfactory outcomes.

[0003] Therefore, it is necessary to invent a rectal balloon funnel stent to solve the problem of poor drainage effect caused by conventional anal tube drainage. Utility Model Content

[0004] In view of this, the purpose of this utility model is to provide a rectal balloon funnel stent, which aims to solve the technical problem that the conventional method of inserting an anal tube to drain feces in order to avoid fecal contamination of the rectal anastomosis often results in poor sealing and drainage effect of the anal tube.

[0005] This utility model provides a rectal balloon funnel stent for draining feces, comprising a stent funnel, a stent body, a balloon, and an inflation assembly. The stent funnel is connected to the stent body, and the balloon is connected to the inflation assembly. The balloon has an annular structure, the stent funnel has a funnel structure, and the stent body has a cylindrical structure. The stent funnel has at least one abutment portion with an outer diameter larger than the inner diameter of the balloon, and the outer diameter of the stent body is smaller than the inner diameter of the balloon. After the inflation assembly inflates the balloon, the stent body passes through the balloon and is located below the balloon. The balloon abuts against the abutment portion to support the stent funnel.

[0006] Furthermore, the balloon includes a support ring, an outer balloon, and an inner balloon enclosed within the outer balloon. Both the inner balloon and the outer balloon are connected to the support ring. An inner cavity is formed within the inner balloon, and an outer cavity is formed between the outer balloon and the inner balloon. When the inflation assembly inflates the balloon, the pressure inside the inner cavity is greater than the pressure inside the outer cavity.

[0007] Furthermore, the inflation assembly includes a first inflation tube, a second inflation tube, a first inflation pump, and a second inflation pump. The support ring has a first inflation hole and a second inflation hole. The first inflation tube is connected to the first inflation hole to connect the outer cavity and the first inflation pump. The second inflation tube is connected to the second inflation hole to connect the inner cavity and the second inflation pump.

[0008] Furthermore, a first detection bladder is connected to the end of the first air pump away from the first air tube, and the first detection bladder is used to detect the pressure of the outer cavity. A second detection bladder is connected to the end of the second air pump away from the second air tube, and the second detection bladder is used to detect the pressure of the inner cavity.

[0009] Furthermore, the stiffness of the support ring is greater than that of the outer balloon and the inner balloon.

[0010] Furthermore, the inner side of the support ring is provided with a plurality of limiting protrusions, which are evenly spaced along the circumferential direction of the support ring. The outer side of the support funnel is provided with a limiting groove corresponding to the limiting protrusions. When the outer side of the support funnel abuts against the balloon, the limiting protrusions are engaged in the limiting groove to restrict the rotation of the support funnel relative to the balloon.

[0011] Furthermore, both the inner and outer balloons are made of soft silicone.

[0012] Beneficial effects: Because the stent funnel in this application is funnel-shaped with a large opening, it can better receive feces when placed in the rectum, thus having a better drainage effect. In addition, this application uses balloon inflation to support the stent funnel, thus having good support and sealing. Attached Figure Description

[0013] Figure 1 This is a schematic diagram of the overall structure of this utility model;

[0014] Figure 2 for Figure 1 Enlarged view of point A in the middle;

[0015] Figure 3 This is a schematic diagram of the structure when the stent funnel and the balloon are in contact.

[0016] Figure 4 This is a cross-sectional view of the balloon;

[0017] Figure 5 This is a schematic diagram of the structure of the present invention when it is fixed in the rectum.

[0018] In the diagram: 1. Stent funnel; 2. Stent body; 3. Balloon; 31. Support ring; 311. Limiting protrusion; 312. Limiting groove; 32. Outer balloon; 321. Outer cavity; 33. Inner balloon; 331. Inner cavity; 34. Inflation assembly; 41. First inflation tube; 42. Second inflation tube; 43. First inflation pump; 44. Second inflation pump; 45. First detection balloon; 46. Second detection balloon; 47. First inflation port; 48. Second inflation port; 5. Rectal anastomosis; 6. Scale line. Detailed Implementation

[0019] The technical solutions of the present utility model will be clearly and completely described below with reference to the accompanying drawings of the embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present utility model without creative effort are within the scope of protection of the present utility model.

[0020] In existing techniques, to avoid leakage at the rectal anastomosis during low rectal cancer surgery, the following methods can be used:

[0021] Anal canal insertion: Ordinary anal canals are relatively hard, causing greater discomfort to patients, have poor sealing, a high chance of feces entering the rectal anastomosis site, and the anal canals are flat-headed and relatively thin on both sides, resulting in poor drainage.

[0022] Anastomotic covered stent: An anastomotic peritoneal stent can be attached to the rectal anastomosis 5 to isolate the fecal passage from the rectal anastomosis 5, but it is expensive and the peritoneal stent has poor sealing between the fecal passage and the anastomosis 5.

[0023] Prophylactic terminal ileostomy: This procedure requires surgical diversion of the fecal pathway and a second surgery to reduce the ileostomy, causing significant harm to the patient.

[0024] For issues arising from the above methods, please refer to [link / reference]. Figures 1 to 5This utility model provides a rectal balloon funnel stent for draining feces, including a stent funnel 1, a stent body 2, a balloon 3, and an inflation assembly 34. The stent funnel 1 is connected to the stent body 2, and the balloon 3 is connected to the inflation assembly 34. The balloon 3 has an annular structure, the stent funnel 1 has a funnel structure, and the stent body 2 has a cylindrical structure. The stent funnel 1 has at least one abutting portion with an outer diameter larger than the inner diameter of the balloon 3. The outer diameter of the stent body 2 is smaller than the inner diameter of the balloon 3. After the inflation assembly 34 inflates the balloon 3, the stent body 2 passes through the balloon 3 and is located below the balloon 3. The balloon 3 abuts against the abutting portion to support the stent funnel 1.

[0025] The specific placement procedure of this application is as follows: After rectal anastomosis, the rectal balloon funnel stent is retrieved, and the patency of the balloon 3, stent funnel 1, and stent body 2 is verified. Paraffin oil is used to lubricate the flared end of the stent funnel 1 and the balloon 3. The stent funnel 1, stent body 2, and balloon 3 are then inserted along the anus. Under direct laparoscopic visualization, it is confirmed that the flared end of the stent funnel 1 has reached approximately 5 cm above the rectal anastomosis 5. Simultaneously, it is ensured that the end of the stent body 2 near the anal verge is located below the rectal anastomosis 5 and extends to the lateral side of the anal verge for smooth defecation. After confirming the correct position, the inflation component 34 inflates the balloon 3 to fix the stent funnel 1. The stent funnel 1 is slightly pulled back to confirm its fixation, completing the placement of the stent funnel 1. The portion of the stent body 2 exposed at the anal verge is trimmed to ensure no discomfort for the patient. The stent body 2 is then sutured to the skin at the anal verge. Specifically, the stent body 2 in this application is made of soft silicone to facilitate suturing. The doctor first uses a suture needle to puncture the skin and the support structure sequentially on one side of the anal margin, pulling the needle and suture out from the inside of the support structure, leaving a section of suture on one side of the skin. Then, the needle tip is flipped over, and the support structure and skin are punctured again sequentially from the inside. The suture is then tied to the remaining suture on the skin side to secure the wound. This process is repeated along the anal margin until the entire wound is sutured. At the last puncture site, the doctor ligates the suture and trims both ends appropriately.

[0026] Reference Figure 3In one feasible embodiment, the balloon 3 includes a support ring 31, an outer balloon 32, and an inner balloon 33 enclosed within the outer balloon 32. Both the inner balloon 33 and the outer balloon 32 are connected to the support ring 31. An inner cavity 331 is formed within the inner balloon 33, and an outer cavity 321 is formed between the outer balloon 32 and the inner balloon 33. The outer balloon 32 and the inner balloon 33 are respectively connected to the inflation assembly 34. After the inflation assembly 34 inflates the balloon 3, the pressure within the inner cavity 331 is greater than the pressure within the outer cavity 321. It is worth noting that in this embodiment, the hardness of the support ring 31 is greater than the hardness of the outer balloon 32 and the inner balloon 33. The support ring 31 primarily provides support for the inner balloon 33 and the outer balloon 32. As gas is continuously injected into the outer cavity 321 and the inner cavity 331, the gas inside the outer balloon 32 or the inner balloon 33 increases, and the outer balloon 32 or the inner balloon 33 expands accordingly. If the outer balloon 32 or the inner balloon 33 expands too much, its size can be adjusted by controlling the inflation volume to control the pressure in the inner cavity 331 and the outer cavity 321. Gas injection is stopped when the outer balloon 32 or the inner balloon 33 expands to a suitable size. The outer balloon 32 has a certain degree of extensibility after gas injection. When the outer balloon 32 is adapted to the size of the rectum of the corresponding shape, it can conform to the inner wall of the rectum to achieve rectal occlusion.

[0027] Furthermore, in this embodiment, after the outer cavity 321 and the inner cavity 331 are inflated, the pressure of the inner balloon 33 is greater than that of the outer balloon 32, making the outer balloon 32 more easily deformable than the inner balloon 33. Because the inner balloon 33 has a higher pressure, it has a stronger load-bearing capacity and is less prone to deformation; therefore, the inner balloon 33 can be used to fix its relative position to the rectum. Because the outer balloon 32 has a lower pressure and is easily deformable, it can be used to adjust the relative position of the balloon 3 to the rectum, making the balloon 3 more adaptable and conforming, and applicable to a wider range and various shapes of rectums. In this embodiment, the inner balloon 33 ensures the anchoring stability of the balloon 3, while the design of the outer balloon 32 allows this application to be applied to rectums of different shapes. The volume of gas injected into the outer cavity 321 can be flexibly adjusted to adapt to rectums of different sizes. There is no need to set multiple models and sizes, reducing the complexity of the use process, greatly reducing the difficulty of the operation, shortening the surgical training cycle, and reducing the requirements for surgical operators.

[0028] Reference Figure 1In one embodiment, the inflation assembly 34 can be an electric inflation pump to automatically inflate the balloon 3. Preferably, the inflation assembly 34 includes a first inflation tube 41, a second inflation tube 42, a first inflation pump 43, and a second inflation pump 44. The support ring 31 has a first inflation hole 47 and a second inflation hole 48. The first inflation tube 41 is connected to the first inflation hole 47 to connect the outer cavity 321 and the first inflation pump 43, and the second inflation tube 42 is connected to the second inflation hole 48 to connect the inner cavity 331 and the second inflation pump 44. The first inflation tube 41 and the second inflation tube 42 allow the balloon 3 to be inflated outside the intestinal lumen via the first inflation pump 43 and the second inflation pump 44. To facilitate inflation, a one-way valve and a vent valve can be correspondingly provided on both the first inflation tube 41 and the second inflation tube 42. The balloon 3 is inflated using a one-way valve and a pressure bulb. If the target pressure is not reached, inflation continues until the ideal pressure is achieved, thus controlling the pressure of the balloon 3. If over-inflation occurs, the pressure can be released through the pressure relief valve.

[0029] Reference Figure 1 In one feasible embodiment, a first detection balloon 45 is connected to the end of the first inflation pump 43 away from the first inflation tube 41. The first detection balloon 45 is used to detect the pressure of the outer cavity 321. A second detection balloon 46 is connected to the end of the second inflation pump 44 away from the second inflation tube 42. The second detection balloon 46 is used to detect the pressure of the inner cavity 331. In this embodiment, the inflation volume and rigidity of the inner balloon 33 and the outer balloon 32 above the rectal anastomosis 5 can be evaluated by the hardness and size of the first detection balloon 45 and the second detection balloon 46. It is worth noting that the outer balloon 32 needs to be inflated to the hardness of the nasal tip to ensure the stability of the outer balloon 32 in the rectum; while the inner balloon 33 needs to be harder than the outer balloon 32 to provide sufficient support.

[0030] Reference Figure 1 and Figure 2 In one feasible embodiment, the inner side of the support ring 31 is provided with a plurality of limiting protrusions 311, which are evenly spaced along the circumferential direction of the support ring 31. The outer side of the stent funnel 1 is provided with limiting grooves 312 corresponding to the limiting protrusions 311. When the outer side of the stent funnel 1 abuts against the balloon 3, the limiting protrusions 311 are engaged in the limiting grooves 312 to restrict the rotation of the stent funnel 1 relative to the balloon 3. In this embodiment, the limiting protrusions 311 engaging in the limiting grooves 312 can improve the stability of the stent funnel 1 in the rectum.

[0031] In one feasible implementation, both the inner balloon 33 and the outer balloon 32 are made of soft silicone. The use of soft silicone for the balloon 3 reduces discomfort caused to the patient by the rigid anal canal and stent, making it suitable for longer periods of patient use.

[0032] It is worth noting that all components in this application are made of soft silicone, allowing for extended carrying time. This application isolates the rectal anastomosis 5 from fecal matter, enabling early enteral nutrition for the patient. Patients can wait 7 days or more until the rectal anastomosis 5 is confirmed to be firmly healed. After deflating the balloon 3, the product is removed gently to avoid damaging the rectal anastomosis 5. If leakage still occurs at the rectal anastomosis 5 after removal of the product, to allow for longer healing time and maintain enteral nutrition, avoiding a second surgery for a prophylactic terminal ileostomy, the product can be reinserted, provided the rectal anastomosis 5 is not torn. The product should be removed before the pelvic drainage tube inserted during surgery. After removal, the condition of the pelvic drainage tube can be used to assess the leakage status of the rectal anastomosis 5.

[0033] Furthermore, referring to Figure 5 The outer wall of the support body 2 is provided with scale lines 6. In this embodiment, the scale lines 6 mark the depth to which the support body 2 is placed in the rectum, so as to better confirm the position.

[0034] It will be apparent to those skilled in the art that this application is not limited to the details of the exemplary embodiments described above, and that this application can be implemented in other specific forms without departing from the spirit or essential characteristics of this application. Therefore, the embodiments should be considered illustrative and non-limiting in all respects, and the scope of this application is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of the equivalent elements of the claims are intended to be included within this application. No reference numerals in the claims should be construed as limiting the scope of the claims.

[0035] The above-described embodiments are only used to illustrate the technical solutions of this application, and are not intended to limit them. Although this application has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of this application.

Claims

1. A rectal balloon funnel stent for draining feces, characterized in that: The device includes a support funnel (1), a support body (2), a balloon (3), and an inflation assembly (34). The support funnel (1) is connected to the support body (2), and the balloon (3) is connected to the inflation assembly (34). The balloon (3) has an annular structure, the support funnel (1) has a funnel structure, and the support body (2) has a cylindrical structure. The support funnel (1) has at least one abutting part with an outer diameter larger than the inner diameter of the balloon (3). The outer diameter of the support body (2) is smaller than the inner diameter of the balloon (3). After the inflation assembly (34) inflates the balloon (3), the support body (2) passes through the balloon (3) and is located below the balloon (3). The balloon (3) abuts against the abutting part to support the support funnel (1). The main body (2) of the support is made of soft silicone material and is used for suturing with the anal margin; The balloon (3) includes a support ring (31), an outer balloon (32), and an inner balloon (33) wrapped inside the outer balloon (32). The inner balloon (33) and the outer balloon (32) are both connected to the support ring (31). An inner cavity (331) is formed inside the inner balloon (33), and an outer cavity (321) is formed between the outer balloon (32) and the inner balloon (33). The outer balloon (32) and the inner balloon (33) are respectively connected to the inflation assembly (34). When the inflation assembly (34) inflates the balloon (3), the pressure in the inner cavity (331) is greater than the pressure in the outer cavity (321).

2. The rectal balloon funnel stent according to claim 1, characterized in that: The inflation assembly (34) includes a first inflation tube (41), a second inflation tube (42), a first inflation pump (43), and a second inflation pump (44). The support ring (31) has a first inflation hole (47) and a second inflation hole (48). The first inflation tube (41) is connected to the first inflation hole (47) to connect the outer cavity (321) and the first inflation pump (43). The second inflation tube (42) is connected to the second inflation hole (48) to connect the inner cavity (331) and the second inflation pump (44).

3. The rectal balloon funnel stent according to claim 2, characterized in that: The first air pump (43) is connected to a first detection bladder (45) at one end away from the first air tube (41). The first detection bladder (45) is used to detect the pressure of the outer cavity (321). The second air pump (44) is connected to a second detection bladder (46) at one end away from the second air tube (42). The second detection bladder (46) is used to detect the pressure of the inner cavity (331).

4. The rectal balloon funnel stent according to claim 1, characterized in that: The hardness of the support ring (31) is greater than that of the outer balloon (32) and the inner balloon (33).

5. A rectal balloon funnel stent according to claim 1, characterized in that: The inner side of the support ring (31) is provided with a plurality of limiting protrusions (311), and the plurality of limiting protrusions (311) are evenly spaced along the circumferential direction of the support ring (31). The outer side of the support funnel (1) is provided with a limiting groove (312) corresponding to the limiting protrusions (311). When the outer side of the support funnel (1) abuts against the balloon (3), the limiting protrusions (311) are engaged in the limiting groove (312) to restrict the rotation of the support funnel (1) relative to the balloon (3).

6. A rectal balloon funnel stent according to claim 1, characterized in that: Both the inner balloon (33) and the outer balloon (32) are made of soft silicone.

7. A rectal balloon funnel stent according to claim 1, characterized in that: The outer wall surface of the support body (2) is provided with scale lines (6).