Anus hemostasis inflatable air bag

Abstract

The invention relates to medical instruments related to anus treatment, in particular to an anus hemostasis inflatable airbag. The anus hemostasis inflatable airbag is characterized by comprising a distraction structure and a catheter body, the opening structure comprises a conical curtain and an elastic folding rope arranged at the top of the conical curtain, the elastic folding rope is in a folded state when not used, and the elastic folding rope is in an unfolded state when used and supports the conical curtain to be in a horn mouth shape; the catheter body comprises a catheter outer layer, a catheter inner layer and an air bag supporting body arranged between the catheter outer layer and the catheter inner layer, the air bag supporting body is provided with an inflation inlet in a communicated mode, and an anti-slipping ring for preventing slipping is arranged at the bottom of the catheter outer layer. The anal tube supporting device has a good anal tube supporting effect.

Description

Technical Field

[0001] This invention pertains to medical devices related to anal treatment, specifically involving an anal hemostasis inflatable balloon. Background Technology

[0002] Currently, conventional anal hemostasis instruments are used for surgical procedures. During treatment with these instruments, normal defecation is disrupted, causing inconvenience to patients. Furthermore, these instruments are relatively rigid and have fixed shapes, leading to several problems: 1. Patient discomfort and pain: Rigid instruments may exert unnecessary pressure on the anal canal and rectal wall during insertion or manipulation, causing pain or discomfort. Risk of injury: Rigid materials may increase the risk of mechanical damage such as abrasions and tears to the delicate mucosa, especially in cases of pre-existing conditions (such as hemorrhoids or anal fissures). 2. Inconvenience and poor adaptability: The anal and rectal anatomy varies from person to person, and fixed shapes may not adapt well to all patients, affecting treatment outcomes. Difficulty in operation: For doctors, overly rigid instruments may make delicate manipulation difficult, especially when precise positioning and force control are required. 3. Risk of complications and infection: Any open wound carries the risk of infection. Minor trauma caused by rigid instruments, if not properly treated, can become a gateway for bacterial invasion. Increased bleeding: Improper handling may further damage existing bleeding points, thus worsening the bleeding.

[0003] Currently, relevant domestic patents and technologies all have the aforementioned problems, such as Chinese patent publication numbers: CN109498097A, CN114010847A, CN116849748A.

[0004] Currently, hemostatic devices related to airbags have also appeared in China, such as Chinese Patent Publication No. CN218943414U. This patent uses a design with an anal canal body, an anal canal channel inside the anal canal body, and a hemostatic airbag wrapped around the outside of the anal canal body. However, this design has the following problems: 1. The anal canal channel is too small, and the size of the anal canal channel is fixed and cannot be adjusted, resulting in a lack of flexibility. 2. The hemostatic airbag is set in a relatively fixed way, without room for adjustment, and cannot adapt well to the anal environment. 3. Patients do not have the ability to continue defecation during use. Summary of the Invention

[0005] The anus is the end of the digestive system. It is located on the midline of the buttocks, connected anteriorly to the perineal central tendon and posteriorly to the anococcygeal ligament. Around the anus are the internal anal sphincter, external anal sphincter, puborectalis muscle, and longitudinal rectal muscle, which together form a strong anorectal ring. Due to the presence of the anorectal ring, the anus is usually closed as a longitudinal fissure, and opens to an opening with a diameter of about 3 cm during defecation.

[0006] Therefore, considering the morphology and structure of the anus, in order to solve the technical problems existing in the background art, the technical solution of the present invention is proposed as follows: An anal hemostasis inflatable balloon includes an expansion structure and a catheter body; The aforementioned support structure includes a conical screen and an elastic folding rope disposed on the top of the conical screen. The elastic folding rope is folded when not in use and is extended when in use, supporting the conical screen in a funnel shape. The catheter body includes an outer layer, an inner layer, and an airbag support disposed between the outer and inner layers. The airbag support is connected to an inflation port, and an anti-slip ring is provided at the bottom of the outer layer to prevent slippage.

[0007] The expanding structure, released during use, rests on the dentate line of the anal canal, preventing the anal hemostatic inflatable balloon from slipping out. Through the natural unfolding of the elastic folding rope, it forms a bundle-like structure. The conical curtain rests on the dentate line at the end of the rectum, and the bundle-like structure of the conical curtain, similar to the morphology of the dentate line, creates a good gear-like meshing effect, improving sealing. The elastic folding rope, in its extended state, supports the conical curtain in a funnel shape, which also matches the funnel shape of the end of the rectum, resulting in a good fit.

[0008] Preferably, the elastic folding rope is made of shape memory metal, and the conical screen is made of rubber or latex. The use of shape memory metal for the elastic folding rope is chosen to balance the overall weight of the equipment and the force required to open the conical screen, while also facilitating the release and removal of the device. The conical screen is made of rubber or latex, but other elastic polymer materials such as PE, butyl rubber, SBR, and EPDM can be considered as equivalent alternatives.

[0009] Preferably, the airbag body has an oblique support structure. One end of the oblique support structure is supported on the outer layer of the catheter, and the vertical direction of the tangent of the curved surface of the outer layer of the catheter at this end forms a certain angle with the oblique support structure. The other end of the oblique support structure is supported on the inner layer of the catheter, and the vertical direction of the tangent of the curved surface of the inner layer of the catheter at this end forms a certain angle with the oblique support structure. The purpose of the oblique support structure is to: 1. Provide a relatively gentle oblique support force for the outer layer of the catheter. Unlike a vertically set support structure or a situation where the outer and inner layers of the catheter are inflated as a whole, the oblique support structure allows for bending, forming a flexible support. 2. A large number of oblique support structures can be set to support the entire outer layer of the catheter. The outer layer of the catheter is a more flexible curved surface, which can be better adjusted according to the shape of the anus to adapt to the external shape. 3. The oblique support structure can provide a wider buffer layer between the outer and inner layers of the catheter, meaning that the catheter body can provide a suitable flexible support effect over a larger range. Considering that the anus is usually closed as a longitudinal fissure and opens to a diameter of about 3cm during defecation, even when the anus is closed, it can be compressed into a specific shape with a smaller cross-sectional area to adapt to the shape of the anal opening.

[0010] Preferably, the airbag support is snake-shaped, and the airbag provides back-and-forth support between the outer and inner layers of the catheter. This snake-shaped airbag support possesses the aforementioned oblique support structure. Preferably, only one snake-shaped airbag support is positioned between the outer and inner layers of the catheter. The advantages of this configuration are: 1. When the anal hemostasis inflatable airbag is in its natural state (i.e., not inserted into the anus), after inflation, it naturally forms an elliptical shape, becoming more circular, while exhibiting outward expansion and gently maintaining this shape. That is, when the shape or size of the anal opening changes, the airbag support can still provide good flexible support. 2. The appropriate support force can be selected according to the inflation size to ensure that the support force of the catheter is appropriate and sufficient to support the catheter to fit the anal canal, avoiding excessive support force of the catheter that may cause discomfort to the patient. It should be noted that this support is different from the airbag support mentioned in the background technology. The support in the background technology cannot be adjusted in terms of the position and structure of the airbag, and the gas compression is too strong compared to the strength of the anal muscles. It can be regarded as an incompressible rigid airbag.

[0011] Preferably, the catheter body can form an elliptical structure after the airbag support body is inflated.

[0012] Preferably, the outer portion of the outer layer of the catheter is provided with a medicated layer.

[0013] Preferably, the dressing layer is a sustained-release dressing layer prepared from glycerin gelatin or polyethylene glycol (PEG).

[0014] Preferably, an anti-slip ring is provided at the bottom of the outer layer of the catheter.

[0015] It should be noted that both the outer and inner layers of the catheter are made of thermoplastic polyurethane (TPU), a material that combines the properties of rigid plastics and soft rubber, exhibiting excellent elasticity and resilience. TPU is very flexible and easily processed into various shapes. Many medical-grade TPUs are biocompatible and suitable for use in medical devices and implants. The elastic modulus of TPU can be adjusted according to the formulation, generally higher than silicone and natural rubber, but lower than most rigid plastics.

[0016] The beneficial effects of this invention are as follows: The anal hemostasis inflatable bladder is reasonably designed, providing good support whether the anus is closed in a longitudinal fissure or open in an opening shape during defecation, while avoiding secondary trauma to the already bleeding area during defecation.

[0017] The catheter body has relatively flexible support and a large anal canal, which provides a large passage for defecation.

[0018] The conical curtain and anti-slip ring form a good fixing and anti-slip function. At the same time, the conical curtain provides a gentle repositioning function for any disturbance of the catheter body along the anal canal.

[0019] The outer part of the catheter is covered with a drug dressing layer. The drug dressing layer is made of glycerin gelatin or polyethylene glycol (PEG). The drug dressing layer with sustained release function is conducive to hemostasis and has anti-inflammatory effect. Attached Figure Description

[0020] Figure 1 This is a perspective view of Example 1.

[0021] Figure 2 This is a cross-sectional view of the outer and inner layers of the catheter after the concealed expansion structure of Example 1.

[0022] Figure 3 This is a cross-sectional view of Example 1.

[0023] Figure 4 This is a perspective view of the hidden outer and inner layers of the catheter in Example 1.

[0024] Figure 5 This is State 1 of Example 2.

[0025] Figure 6 This is state two of Example 2.

[0026] Figure 7 This is state three of Example 2.

[0027] Figure 8This is the first working state of Example 2.

[0028] Figure 9 This is the second working state of Example 2.

[0029] Figure reference numerals: 1. Spreading structure; 2. Catheter body; 3. Conical curtain; 4. Elastic folding rope; 5. Outer layer of catheter; 6. Inner layer of catheter; 7. Airbag support; 8. Medication layer; 9. Anti-slip ring; 10. Inflation port; 11. Chamfer; 12. Anal canal passage. Detailed Implementation

[0030] The present invention will be further illustrated below through examples.

[0031] like Figure 1 The diagram shown is a perspective view of the present invention. The anal hemostasis inflatable balloon includes an opening structure 1 and a conduit body 2. The opening structure 1 includes a conical curtain 3 and an elastic folding rope 4 disposed on the top of the conical curtain 3. The elastic folding rope 4 is folded when not in use and is extended when in use, supporting the conical curtain 3 in a funnel shape. The conduit body 2 is hollow and has an anal canal channel 12 for defecation in the middle.

[0032] The catheter body 2 includes an outer layer 5, an inner layer 6, and an airbag support 7 disposed between the outer layer 5 and the inner layer 6. The airbag support 7 is connected to an inflation port 10. The bottom of the outer layer 5 is provided with an anti-slip ring 9 to prevent slippage. As shown in Figure 2, the outer layer 5 is provided with a medication layer 8.

[0033] like Figure 2 and Figure 3 As shown, it can be observed that the airbag support 7 is arranged in a snake shape, and the airbag support 7 provides back-and-forth support between the outer layer 5 and the inner layer 6 of the catheter, as... Figure 4 As shown, there is only one airbag support 7, and its overall arrangement is similar to a spiral upward structure (not exactly the same as a spiral upward structure). An inflation port 10 is connected to one end of the airbag support 7. Figure 1 As shown, a chamfer 11 is provided at the connection between the conical curtain 3 and the duct body 2. The chamfer 11 is beneficial to the defecation process and reduces resistance and residue.

[0034] like Figure 2As shown, in this embodiment, the air pressure sensor and communication module are integrated within the inflation port 10. This integration detects the internal air pressure of the airbag support 7 and connects it to the external device via the communication module. This allows for monitoring of the working status of the catheter 2 within the body and provides better air pressure support for users who lack sensation in the anal area. In more specific implementation details, the air pressure sensor is preferably from the BOSCH BMP280 / BME280 series, with an LGA package size of only 2.0×2.0×0.95mm, supporting I²C / SPI communication. This sensor integrates temperature compensation and digital signal output, eliminating the need for an external ADC. The communication module can be a low-power Bluetooth chip.

[0035] To facilitate the explanation of the cooperative function of the supporting structure 1 and the anti-slip ring 9 of the present invention, as well as the working state during the specific implementation process, Embodiment 2 is provided for detailed description, such as... Figure 5-7 The diagram shown is a state diagram of Embodiment 2, illustrating the changes in the expanding structure 1. The size of the expanding conical curtain 3 can change with the elastic folding rope 4. It can be understood that during use of the anal hemostasis inflatable balloon, the elastic folding rope 4 is initially in a state of... Figure 4 The state of convergence, such as Figure 8 As shown, when the anal hemostasis inflatable bladder is fully inserted into the anus, the elastic folding rope 4 is fully unfolded, as... Figure 9 As shown, the elastic folding rope 4, the conical curtain 3, and the anti-slip ring 9 form a good set of fixed anti-slip functions.

[0036] It should be noted that in this embodiment, the outer and inner layers of the catheter are made of thermoplastic polyurethane (TPU), and a layer thickness of 0.1-0.2 mm is generally suitable.

[0037] It should be noted that this embodiment uses nitinol as the elastic folding cord, with a nickel:titanium ratio of 50:50. The diameter of the nitinol wire is 0.2-0.5mm, and specific products can be manufactured by Nitinol Devices & Components. The design of the dressing layer in this embodiment is as follows: Glycerin gelatin suppository The basic formula is: 10-20% gelatin, 10-20% glycerin, and 60-80% water. The added drugs are: indomethacin, adrenaline, and Sanguisorba officinalis extract. Specifically, 0.5-1.0 mg of indomethacin, 0.1-0.3 mg of adrenaline, and 1.0-3.0 mg of Sanguisorba officinalis extract are added per gram of the base formula. After obtaining the medicated layer, it is applied to the outer layer of the duct.

[0038] It should be noted that although the airbag support is arranged in a snake shape in this embodiment, according to the spirit of the present invention, if the airbag support is arranged in a columnar shape (prism, cylinder), it can also meet the requirements of the inclined support structure. However, in the actual production process, this arrangement is more difficult and complicated to process than the arrangement in the embodiment. Therefore, compared with the actual process, the snake-shaped arrangement of the airbag support is a more reasonable arrangement.

[0039] Unless otherwise specified, the experimental methods used in the embodiments are conventional methods, and the materials and reagents used are commercially available unless otherwise specified.

[0040] The above detailed description is a specific description of one feasible embodiment of the present invention. This embodiment is not intended to limit the patent scope of the present invention. All equivalent implementations or modifications that do not depart from the so-called equivalent implementations or modifications of the present invention should be included within the scope of the technical solution of the present invention. Of course, the above are only typical examples of the present invention. In addition, the present invention may have many other specific implementations. All technical solutions formed by equivalent substitution or equivalent transformation fall within the scope of protection claimed by the present invention.

Claims

1. An anal hemostatic inflatable bladder, characterized in that: Including the expansion structure and the conduit body; The aforementioned support structure includes a conical screen and an elastic folding rope disposed on the top of the conical screen. The elastic folding rope is folded when not in use and is extended when in use, supporting the conical screen in a funnel shape. The catheter body includes an outer layer, an inner layer, and an airbag support disposed between the outer and inner layers. The airbag support is connected to an inflation port, and an anti-slip ring is provided at the bottom of the outer layer to prevent slippage.

2. The anal hemostasis inflatable balloon according to claim 1, characterized in that: The elastic folding rope is made of memory metal, and the conical curtain is made of rubber or latex.

3. The anal hemostasis inflatable balloon according to claim 1, characterized in that: The airbag support has an oblique support structure. One end of the oblique support structure is supported on the outer layer of the catheter, and the vertical direction of the tangent of the curved surface of the outer layer of the catheter at this end forms a certain angle with the oblique support structure. The other end of the oblique support structure is supported on the inner layer of the catheter, and the vertical direction of the tangent of the curved surface of the inner layer of the catheter at this end forms a certain angle with the oblique support structure.

4. The anal hemostasis inflatable balloon according to claim 3, characterized in that: The airbag support is snake-shaped, and the airbag provides back-and-forth support between the outer and inner layers of the duct.

5. The anal hemostasis inflatable balloon according to claim 3, characterized in that: The catheter body can form an elliptical structure after the airbag support body is inflated.

6. The anal hemostasis inflatable balloon according to claim 5, characterized in that: The outer portion of the outer layer of the catheter is provided with a medicated layer.

7. The anal hemostasis inflatable balloon according to claim 5, characterized in that: The dressing layer is a sustained-release dressing layer prepared from glycerin gelatin or polyethylene glycol (PEG).

8. The anal hemostasis inflatable balloon according to claim 4, characterized in that: The outer bottom of the catheter is provided with an anti-slip ring.

9. The anal hemostasis inflatable balloon according to claim 3, characterized in that: The inflation port has a built-in air pressure sensor that monitors the air pressure inside the airbag support.

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