A break-opening rectal medication device

Abstract

A detachable rectal medication applicator includes a hollow rod-shaped component and an auxiliary component. The rod-shaped component is divided into a tail section, a middle section, and a head section. The internal space of the rod-shaped component forms a drug delivery channel. The drug delivery channel has at least one inlet located at the bottom of the tail section and at least one first outlet located at the head section. The auxiliary component is a hollow cap-shaped component, divided into a tail section, a middle section, and a head section. The auxiliary component is at least fitted onto the head section of the rod-shaped component, i.e., the head section is covered within the internal space of the auxiliary component. A second outlet is provided on the auxiliary component. The auxiliary component is made of a material with lower hardness than the rod-shaped component. During use, a shear force is applied to the auxiliary component fitted onto the head section of the rod-shaped component. Through the auxiliary component, the short rod-shaped head section of the rod-shaped component is subjected to force, causing partial or complete breakage of the vulnerable area. The first outlet opens, and the liquid or viscous medication entering the drug delivery channel flows out through the first outlet and then through the second outlet on the auxiliary component.

Description

Technical Field

[0001] This invention relates to a folding and opening type rectal medication applicator, belonging to the field of medical device technology. Background Technology

[0002] The anal crypts, also known as anal crypts, are located at the dentate line at the end of the human rectum. They are funnel-shaped and open upwards, and there are usually 6 to 8 of them. Inside the anal crypts are anal glands, whose secretions lubricate the passage of stool. During defecation, the anal crypts become shallower and the inner walls of the anal crypts come into contact with the stool. When the openings of the anal glands are blocked by stool, the lubricating fluid secreted by the anal glands cannot enter the anal crypts. The anal crypts become dry, and the shallower, unlubricated inner walls of the anal crypts come into contact with the stool, increasing the friction between the stool and the anal canal wall and affecting the smooth passage of stool. Moreover, the anatomical features of the anal crypts make it easy for stool and foreign objects to accumulate within them. Once bacteria become infected, the inflammatory substances are difficult to drain. Inflammation of the anal crypts often irritates the anal sphincter, causing spasms that can induce constipation and may also lead to other anorectal diseases such as perianal abscesses.

[0003] Constipation is a common clinical symptom, with a prevalence rate as high as 27% in the population. Currently, rectal administration is the most widely used treatment for constipation in clinical practice. One of the principles of rectal administration for treating constipation is to inject medication into the rectum, lubricating and softening the anal and rectal walls and expelling feces, thereby relieving constipation symptoms. The most typical rectal administration device is an enema. Currently, before using an enema, the outlet is usually blocked with a stopper or cap to prevent leakage. When using it, the stopper or cap is removed, and the rigid injection tube is pushed into the anus. The anal and rectal mucosa is easily damaged by mechanical force, making the operation relatively cumbersome.

[0004] This invention provides a breakable rectal medication applicator, which uses a flexible auxiliary component to contact the rectal mucosa. Before use, the vulnerable area near the liquid outlet can be broken off, making it easy to operate. Furthermore, the liquid outlet is located on the side, making it easier for the liquid to contact the rectal wall and lubricate the stool. Summary of the Invention

[0005] The objective of this invention is achieved as follows:

[0006] A foldable rectal medication applicator includes a hollow rod-shaped component and an auxiliary component. The rod-shaped component is divided into a tail section, a middle section, and a head section. The internal space of the rod-shaped component forms a drug delivery channel. The drug delivery channel has at least one inlet located at the bottom of the tail section and at least one first outlet located at the head section. The auxiliary component is hollow and cap-shaped, divided into a tail section, a middle section, and a head section. The auxiliary component is at least fitted onto the head section of the rod-shaped component, i.e., the head section is covered within the internal space of the auxiliary component. A second outlet (202) is provided on the auxiliary component (2). The auxiliary component is made of a material with a lower hardness than the rod-shaped component and is located at the head section. The first outlet of the drug channel within the main body of the component is sealed off at the head of the rod-shaped component. A vulnerable area is located at the junction of the head of the short rod-shaped component and the middle part of the rod-shaped component. During use, shear force is applied to the auxiliary component sleeved outside the head of the rod-shaped component. Through the auxiliary component, the vulnerable area is partially or completely broken at the head of the short rod-shaped component, and the first outlet opens. The liquid or viscous drug entering the drug channel flows out through the first outlet and then through the second outlet opened on the auxiliary component. The first and second outlets are preferably designed to be adjacent but partially misaligned to avoid backflow of the drug. Furthermore, the position and shape of the first outlet, which appears randomly when the component breaks, naturally form a partial misalignment with the second outlet, ensuring the anti-backflow effect.

[0007] The head of the rod-shaped component is enclosed within the internal space of the auxiliary component. This enclosed ...

[0008] The first drug outlet is closed off at the head of the rod-shaped component. This means that there is no pre-set first drug outlet in the head region of the rod-shaped component and at the junction of the head and the middle part of the rod-shaped component. Alternatively, the head region may have a first drug outlet, but this outlet is closed by an auxiliary component. The vulnerable area is the junction of the head and the middle part of the rod-shaped component. The shearing force refers to the force applied at a certain angle to the middle part of the rod-shaped component, causing the short rod-shaped head to bend relative to the middle part of the rod-shaped component. The short rod-shaped head refers to the description in comparison with the entire rod-shaped component. The length of the head can also be set to account for more than 50% of the total length of the rod-shaped component, for example, to meet the requirement that the first drug outlet is positioned closer to the drug inlet at the bottom of the tail of the rod-shaped component.

[0009] Furthermore, the outer surface of the rod-shaped component is provided with annular ribs to prevent the auxiliary component sleeved on it from detaching under external force, specifically to prevent the auxiliary component from detaching radially from the head of the rod-shaped component.

[0010] The auxiliary component is designed to thoroughly wipe the anal sinuses and clean the anal canal. It is equipped with protrusions, including those in the form of cords, nails, bosses, hooks, teardrops, horizontal stripes, scattered dots, serrations, beads, wrinkles, terraces, burrs, and continuous spirals, as well as pits that can accommodate drugs and feces.

[0011] Furthermore, at least a portion of the auxiliary component is free to become a foldable part, including a skirt-shaped, umbrella-shaped, leaf-shaped, or bud-shaped part; the free nature of the auxiliary component means that this part is not integrated with the auxiliary component but can deform and move within a certain range, including tensile deformation, bending deformation, and folding deformation.

[0012] In order to smoothly pass through the anal right angle into the rectum, more effectively lubricate the rectal mucosa, and promote the defecation reflex, at least a portion of the head of the rod-shaped component and / or at least a portion of the head of the auxiliary component are bent to one side.

[0013] In order to open the anal canal, increase the contact area, more effectively stimulate the anal canal mucosa, and promote defecation, the outer surface of the rod-shaped component and / or the outer surface of the auxiliary component protrudes outward to form at least one enlarged portion.

[0014] The anal canal is the end of the digestive tract, extending from the dentate line at the top to the anal verge at the bottom. Its length is closely related to defecation function. To measure the length of the anal canal, the outer surface of the rod-shaped component is provided with graduations that increase sequentially from the head of the rod-shaped component to the tail of the auxiliary component.

[0015] Furthermore, the auxiliary component is provided with a weak part that is prone to deformation, corresponding to the vulnerable area of ​​the rod-shaped component. The "corresponding" means that the part of the auxiliary component sleeved outside the vulnerable area of ​​the rod-shaped component is a weak part that is prone to deformation.

[0016] In order to securely fix the auxiliary component to the rod-shaped component, a constraint component is also included, which is sleeved on the outer surface of the tail of the auxiliary component so that it is in close contact with the corresponding area of ​​the rod-shaped component.

[0017] For delivering fluid substances that can be used for lubrication, cleaning, and treatment, the device also includes a container that can be sealed to or integrally formed with the tail of the rod-shaped component, the inner cavity of which contains a liquid or paste-like agent; the agent may refer to drug solutions, emulsions, ointments, and gels, etc., which play a role in lubrication, antibacterial, cleaning, and promoting wound healing, and may also be used for the injection of probiotics.

[0018] The beneficial effects of this invention are:

[0019] 1. No separate parts are needed to close or open the dispensing port, making operation simple.

[0020] 2. The first and second drug outlets are located on different parts. When the device is broken, the position and shape of the first drug outlet will naturally be misaligned with the second drug outlet, which acts as a one-way valve to prevent the backflow of liquid or paste-like drugs in the container cavity. The drug outlet is located on the side, which can fully lubricate the anal mucosa and promote defecation.

[0021] 3. The functional structure on the flexible auxiliary component can fully wipe the anal canal mucosa and act on the defecation receptors, which helps with defecation induction, anal canal maintenance, and prevention and treatment of anal canal diseases such as anal sinusitis. Attached Figure Description

[0022] The following figures are not limited to the present invention:

[0023] Figure 1A Anatomical diagram of the anal canal and anal sinuses;

[0024] Figure 1B Schematic diagram of a cross-section of the anal sinus;

[0025] Figure 1C Schematic diagram of Embodiment 1 of the present invention

[0026] Figure 1D Cross-sectional view of each component separated in Example 1

[0027] Figure 1E Cross-sectional view of the assembled components in Example 1

[0028] Figure 1F Cross-sectional view of Example 1 in its unbroken state.

[0029] Figure 1G Cross-sectional view of the broken state in Example 1

[0030] Figure 1H Example 1: Schematic diagram of the anal canal not being entered.

[0031] Figure 1I Example 1: Schematic diagram of entry into the anal canal

[0032] Figure 1J Example 1: Schematic diagram of the withdrawal of the anal canal

[0033] Figure 2A Example 2: A schematic diagram at one angle

[0034] Figure 2B : Another schematic diagram of Example 2

[0035] Figure 3A Schematic diagram of Example 3

[0036] Figure 3B Cross-sectional view of Example 3

[0037] Figure 3C Example 3: Cross-sectional view of the device entering the rectum.

[0038] Figure 4A Schematic diagram of Example 4

[0039] Figure 4B Cross-sectional view of Example 4

[0040] Figure 5A Example 5: Cross-sectional view showing the separation of the auxiliary component and the rod-shaped component.

[0041] Figure 5B Example 5: Cross-sectional view of the combination of auxiliary component and rod-shaped component. Detailed Implementation

[0042] Example 1:

[0043] like Figure 1A , 1B As shown, the location and brief structure of the human anal sinus are first explained: the anal canal A1, the dentate line A2, the anal sinus A3, and the opening A5 of the anal gland A4 is blocked by feces or foreign objects B.

[0044] like Figure 1C-1J As shown in the accompanying drawings, Embodiment 1 of the present invention includes a foldable rectal medication applicator, comprising a hollow rod-shaped component 1 and an auxiliary component 2. The main body of the rod-shaped component 1 is divided into a rod-shaped component tail 11, a rod-shaped component middle portion 12, and a rod-shaped component head 13. The internal space of the rod-shaped component main body forms a drug channel 10 for delivering medication. The drug channel 10 is provided with at least one drug inlet 101 located at the bottom end of the rod-shaped component tail 11 and at least one first drug outlet 102 located at the rod-shaped component head 13. Figure 1D The first drug outlet 102 adjacent to the vulnerable area 1312 is shown to be in a closed state; the auxiliary component 2 has a hollow cap-shaped main body and can be molded from medical-grade thermoplastic elastomer (TPE) material or silicone rubber material, etc. It not only has good biocompatibility, but also has a soft texture and is more comfortable to contact with the human body. The auxiliary component 2 is divided into an auxiliary component tail 21, an auxiliary component middle part 22, and an auxiliary component head 23. The auxiliary component 2 is at least fitted onto the rod-shaped component head 13, that is, the rod-shaped component head 13 is covered in the internal space 20 of the auxiliary component. Component 2 is made of a material with lower hardness than rod-shaped component 1. The first drug outlet 102 of the drug channel 10 located inside the main body of the rod-shaped component is closed to the outside at the head 13 of the rod-shaped component. A vulnerable area 1312 with a local thin circumferential wall is provided at the junction of the short rod-shaped component head 13 and the middle part 12 of the rod-shaped component. During use, shear force is applied to the auxiliary component 2 sleeved outside the head 13 of the rod-shaped component. Through the auxiliary component 2, the short rod-shaped rod-shaped component head 13 is subjected to force, and the vulnerable area 1312 is partially or completely broken, and the first drug outlet 102 is opened. Figure 1GAs shown, the liquid or viscous medicine entering the drug channel 10 first flows out through the first drug outlet 102 and then through the second drug outlet 202 opened on the auxiliary component 2; the auxiliary component 2 is provided with a hook-shaped protrusion 242 and a recess 243 that can accommodate medicine and feces; the outer surface 14 of the rod-shaped component is provided with scale lines S that increase sequentially from the head 13 of the rod-shaped component to the tail 11 of the rod-shaped component, which are used to measure the length of the anal canal A1; it also includes a container V that can be sealed to the tail 11 of the rod-shaped component, and the inner cavity V0 of the container contains liquid or paste medicine F; the auxiliary component 2 is provided with a weak part 244 that is easily deformed and corresponds to the vulnerable area 1312 of the rod-shaped component, that is, the part of the auxiliary component that is sleeved outside the vulnerable area 1312 of the rod-shaped component is a weak part that is easily deformed and is more likely to break the vulnerable area 1312, so that the liquid or paste medicine F in the inner cavity V0 of the container flows out into the rectum.

[0045] like Figure 1C-1F The outer surface 14 of the rod-shaped component is provided with an annular rib 141 to prevent the auxiliary component 2 sleeved on it from detaching; the outer surface 14 of the rod-shaped component and / or the outer surface 24 of the auxiliary component protrude outward to form at least one enlarged portion 241; the head 13 of the rod-shaped component is covered within the internal space 20 of the auxiliary component, which can be a tight and seamless covering or a covering with a gap 201, the gap 201 communicating with the second drug outlet 202; the first drug outlet 102 is closed to the outside at the head 13 of the rod-shaped component, meaning that the first drug outlet 102 is not pre-opened at the junction 1312 of the head and the middle part 12 of the rod-shaped component; the vulnerable area is the junction 1312 of the head 13 and the middle part 12 of the rod-shaped component; such as Figure 1G The vulnerable area 1312 is broken by shear force. Shear force refers to the force applied at a certain angle to the middle part 12 of the rod-shaped component, so that the short rod-shaped head 13 bends relative to the middle part 12 of the rod-shaped component. The first and second drug outlets are preferably designed to be adjacent but partially misaligned (figure omitted) to avoid backflow of liquid or paste-like drugs in the container cavity V0. Moreover, the position and shape of the first drug outlet that appears randomly when broken will naturally form a partial misalignment with the second drug outlet, ensuring the anti-backflow effect.

[0046] like Figure 1H The diagram shown is a schematic of the insertion into the anal canal A1 in Embodiment 1. The protrusion 242 on the auxiliary component 2 scrapes away fecal matter B or inflammatory secretions accumulated in the anal sinus; as shown... Figure 1I As shown, in Example 1, the liquid inside the anal canal A1 enters the rectum through the container's inner cavity V0; as... Figure 1J As shown in Example 1, the anal canal A1 is removed. At this time, the protrusion 242 on the auxiliary component 2 cleans the anal sinus again, and the recess 243 on the auxiliary component 2 carries the contained feces or inflammatory secretions out of the body.

[0047] Example 2:

[0048] like Figure 2A-2B As shown, unlike the above embodiment, at least a portion of the auxiliary component 2 is freed to become a foldable portion 25, including a skirt-like, umbrella-like, leaf-like, or bud-like shape. The connection between the foldable portion 25 and the auxiliary component 2 can be designed to be difficult to separate, specifically, the friction generated during entry and exit from the anal canal makes it difficult to separate. The foldable portion 25 can deform and move within a certain range, including stretching deformation, bending deformation, and folding deformation. The foldable portion 25 can be provided with secondary protrusions 251 and secondary depressions 252, which can fully wipe away and remove feces, inflammatory secretions, etc. from the anal sinus and contain them in the depressions for removal from the body. This helps to eliminate constipation caused by anal sinus inflammation and helps to prevent and treat anal sinus inflammation after diarrhea. The secondary depressions can also contain a certain amount of drugs with lubricating, cleaning, and antibacterial effects. Figure 2A This refers to the state of the foldable portion before it is folded; for example... Figure 2B This refers to the state after the foldable part has been folded.

[0049] Example 3:

[0050] The anorectal angle is the angle formed by the lower rectum and the axis of the anal canal. It is an important factor in controlling defecation. Under normal circumstances, when sitting still, the rectum is evenly filled and the anorectal angle is 90° to 110°. When defecation, the puborectalis muscle relaxes and the anorectal angle increases to 120° to 140°. The anus and rectum open in a funnel shape and most or all of the feces are emptied.

[0051] like Figures 3A-3C As shown, unlike Embodiment 1, at least a portion of the head 13 of the rod-shaped component and at least a portion of the head 23 of the auxiliary component are bent to one side to conform to the anal angle, stimulating the rectal sensory nerves, causing a feeling of rectal distension, effectively stimulating the rectal distension sensation and inducing the distension reflex, producing the urge to defecate; and when the top bend rotates, it can further stimulate the nerve endings in the anal cushion area, such as the tension receptor Pacinian corpuscle, the friction receptor Genital corpuscle, and the pressure receptor Golgi-Mazzoni body, inducing the defecation reflex; Figure 3C The diagram shown is a schematic of Example 3, which shows the passage through the anal right angle into the rectum.

[0052] Example 4:

[0053] like Figures 4A-4BAs shown, unlike Embodiment 1, it also includes a restraining component C, which is sleeved on the outer surface of the tail 21 of the auxiliary component, so that the area corresponding to the head 13 of the rod-shaped component is in close contact with the auxiliary component 2. This prevents the auxiliary component 2 from detaching from the rod-shaped component 1 due to friction or other reasons during the insertion and removal of the anal tube, or from the liquid or paste-like medicine F in the inner cavity V0 of the container from flowing out through the gap between the auxiliary component 2 and the rod-shaped component 1 after the vulnerable area 1312 of the rod-shaped component breaks due to insufficient sealing between the auxiliary component 2 and the rod-shaped component 1. The restraining component C can further prevent the medicine from flowing out through the gap.

[0054] Example 5:

[0055] like Figures 5A-5B As shown, unlike Example 1, the tail 11 of the rod-shaped component is integrally formed with the container V, and the inner cavity V0 of the container contains a liquid or paste-like drug F; the first step in the specific manufacturing process is as follows: Figure 5A As shown, before the liquid or paste-like drug F is injected, the head 13 of the rod-shaped component has an injection hole 130. The liquid or paste-like drug is injected into the container V, which is integrally formed with the rod-shaped component 1, through this injection hole 130. The second step is to use a heat-sealing machine to partially heat-seal the injection hole 130, or to partially fill it with sealing adhesive to prevent the liquid or paste-like drug from leaking out of the container V. The third step is to install the auxiliary component 2 onto the head 13 of the rod-shaped component. Figure 5B ).

Claims

1. A breakable rectal medication applicator, comprising a hollow rod-shaped component (1) and auxiliary components (2), wherein the rod-shaped component (1) is divided into a rod-shaped component tail (11), a rod-shaped component middle part (12), and a rod-shaped component head (13), and the internal space of the rod-shaped component body forms a drug channel (10) for delivering drugs, the drug channel (10) having at least one drug inlet (101) located at the bottom end of the rod-shaped component tail (11) and at least one drug inlet (101) located at the head of the rod-shaped component head (13). A first drug outlet (102); the auxiliary component (2) is a hollow cap-shaped body, divided into an auxiliary component tail (21), an auxiliary component middle part (22), and an auxiliary component head (23). The auxiliary component (2) is at least fitted onto the head (13) of the rod-shaped component, that is, the head (13) of the rod-shaped component is covered in the internal space (20) of the auxiliary component. A second drug outlet (202) is provided on the auxiliary component (2). The hardness of the material of the auxiliary component (2) is lower than that of the rod-shaped component (1). Its characteristics are: The first outlet (102) of the drug channel (10) located inside the rod-shaped component is closed to the outside at the head (13) of the rod-shaped component. A vulnerable area (1312) is provided at the junction of the short rod-shaped head (13) and the middle part (12) of the rod-shaped component. When in use, shear force is applied to the auxiliary component (2) sleeved outside the head (13) of the rod-shaped component. Through the auxiliary component (2) acting on the short rod-shaped head (13), the vulnerable area (1312) is partially or completely broken, the first outlet (102) is opened, and the liquid or viscous drug entering the drug channel (10) flows out through the first outlet (102) and then through the second outlet (202) opened on the auxiliary component (2).

2. The reversible rectal medication applicator according to claim 1, characterized in that: The outer surface (14) of the rod-shaped component is provided with annular ribs (141) to prevent the auxiliary component (2) sleeved on it from detaching under external force.

3. The reversible rectal medication applicator according to claim 1, characterized in that: The auxiliary component (2) is provided with protrusions (242) including those in the form of strips, nails, bosses, hooks, teardrops, horizontal stripes, scattered dots, serrations, beads, wrinkles, terraces, burrs, and continuous spirals, and or with depressions (243) that can accommodate drugs and feces.

4. The reversible rectal medication applicator according to claim 1, characterized in that: At least a portion of the auxiliary component (2) is freed to become a foldable part (25) including a skirt-shaped, umbrella-shaped, leaf-shaped, or bud-shaped part.

5. The reversible rectal medication applicator according to claim 1, characterized in that: At least a portion of the head (13) of the rod-shaped component and at least a portion of the head (23) of the auxiliary component are bent to one side.

6. The reversible rectal medication applicator according to claim 1, characterized in that: The outer surface (14) of the rod-shaped component and / or the outer surface (24) of the auxiliary component protrude outward to form at least one bulge (241).

7. The reversible rectal medication applicator according to claim 1, characterized in that: The outer surface (14) of the rod-shaped component is provided with scale lines (S) that increase sequentially from the head (13) of the rod-shaped component to the tail (21) of the auxiliary component, for measuring the length of the anal canal (A1).

8. The reversible rectal medication applicator according to claim 1, characterized in that: The auxiliary component (2) is provided with a weak part (244) that is prone to deformation, corresponding to the vulnerable area (1312) of the rod-shaped component.

9. A breakable rectal medication applicator according to claim 1, characterized in that: It also includes a constraint component (C), which is fitted onto the outer surface of the tail (21) of the auxiliary component so that it is in close contact with the area corresponding to the rod-shaped component.

10. A breakable rectal medication applicator according to claim 1, characterized in that: It also includes a container (V) that can be sealed to or integrally formed with the tail of the rod-shaped component (11), the inner cavity (V0) of which contains liquid or paste-like agents.

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