WO2023036112A1

WO2023036112A1 - Rectal drug delivery apparatus

Info

Publication number: WO2023036112A1
Application number: PCT/CN2022/117206
Authority: WO
Inventors: 董东生; 宋玲玲
Original assignee: 浙江百获健康科技有限公司
Priority date: 2021-09-07
Filing date: 2022-09-06
Publication date: 2023-03-16
Also published as: CN113599682A

Abstract

A rectal drug delivery apparatus, comprising a rod-shaped member (1) having a top end and a bottom end, an auxiliary member (2), and a drug channel (3) used for delivering a drug, the drug channel (3) being provided with at least one drug inlet (31) and at least one drug outlet (32). The auxiliary member (2) is conformably fitted above the rod-shaped member (1). The material of the auxiliary member (2) at least entering the rectum has a hardness less than that of the rod-shaped member (1), the auxiliary member (2) is provided with notches (20) capable of containing a drug and/or fecal substance, and each notch (20) is provided with at least one opening (201).

Description

rectal drug delivery device

technical field

The invention relates to a rectal drug delivery device and belongs to the technical field of medical instruments.

Background technique

Rectal administration of lubricating, stimulant drugs is a common means of coping with constipation; one of the most typical rectal delivery devices is Kaiselu. The traditional Kaisailu consists of a medicine storage bottle and a drug injection tube connected with the medicine storage bottle. When in use, insert the medicine injection tube into the rectum through the anus of the human body, squeeze the medicine storage bottle, and the medicine enters the rectum through the opening of the injection tube and softens. Stool, lubricates the rectal wall, stimulates the mucous membrane and induces the defecation reflex.

The anal sinus at the end of the human rectum is located on the dentate line, also known as the anal recess, which opens upwards in a funnel shape, and usually has 6 to 8. There are anal glands inside the anal sinus, and the secretion of the anal glands can lubricate defecation. When the depression of the anal sinus is opened, the inner wall of the anal sinus is in contact with feces. Increased friction between feces and the wall of the anal canal affects the smooth discharge of feces, and the anatomical characteristics of the anal sinus make it easy for feces and foreign bodies to accumulate in it. Once infected by bacteria, the inflammatory substances are difficult to drain smoothly. Inflammation of the anal sinus often stimulates the anal sphincter , cause spasm, induce constipation and can lead to local ischemia. If the traditional Kaisailu injection tube does not fully lubricate the anal canal wall and its internal structure, the defecation effect is poor. When feces accumulate in the anal sinus, it can cause Anal gland secretions are not excreted smoothly, and bacteria proliferate in large numbers, becoming the main infection focus of anorectal surgery diseases, and has a certain relationship with the occurrence of anorectal cancer; secondly, due to the many folds of the rectal wall, the traditional injection tube It can only deliver the drug into the rectum, but it cannot spread the drug evenly on the rectal wall, so the area where the drug lubricates the rectal wall is very limited, resulting in poor lubrication to the rectal wall, especially for patients with intractable constipation. In addition, for constipation caused by mental stress, too little activity, etc., the anorectum can be stimulated by expansion to promote defecation. The traditional Kaisailu drug injection tube is a smooth tube with no obvious change in inner diameter, which is not enough to exert an effect on the expansion of the anorectal wall. Stimulation; For patients with diarrhea, the thin and soft feces retained in the rectal mucosa and anal sinus are not easy to discharge, and the bacteria, viruses, parasites, etc. in them are more likely to cause inflammation and stimulation, resulting in excessive bacterial reproduction, intestinal transport function defects, Intestinal motility disorder, accompanied by tenesmus, abdominal pain and other symptoms, the smooth thin tube of the traditional Kaiselu into the rectum cannot effectively remove the retained feces, etc. from the body.

In order to solve the defects of the traditional rectal drug delivery device, it is urgent to develop a device that can be smoothly inserted into the rectum of the human body, clean the anal sinus, lubricate the anorectal wall, stimulate the defecation reflex, and effectively remove feces, inflammation, and feces retained in the anal sinus and anorectal mucosa. Rectal drug delivery device that removes secretions, foreign bodies, etc. from the body.

Contents of the invention

In order to solve the above problems, the present invention provides a rectal drug delivery device that can effectively wipe away feces, inflammatory secretions, foreign matter, etc. remaining on the anal sinus and rectal mucosa and remove them from the body.

The purpose of the present invention is achieved like this:

The rectal drug delivery device includes a rod-shaped part with a top end and a bottom end, an auxiliary part and a drug channel for delivering medicine. On top of the part, at least the auxiliary part that enters the rectum is made of a material that is less rigid than the rod-shaped part, and the auxiliary part is provided with a dimple that can hold the drug and/or fecal matter, and the dimple is provided with at least one opening; the rod-shaped Components, auxiliary components, each component can be composed of one part or multiple parts.

The dimple may be a simple depression, or a bag shape with an opening formed by partially covering the depression, or a bag shape formed by partially covering the non-depressed area of the auxiliary component.

In order to fully clean the anal sinus and rectal mucosa, the auxiliary parts are provided with openings in the same direction as and/or intersecting the longitudinal axis of the rod-shaped part, including line-shaped, drop-shaped, scatter-shaped, jagged, beaded, and ring-shaped , wrinkled, terraced, bag-shaped, continuous spiral lacuna, including at least one kind of lacuna.

In order to stimulate and massage the anorectal wall more effectively, and remove feces and foreign objects trapped in the anal sinus from the body, the outer surface of the auxiliary parts is also equipped with rope-shaped, nail-shaped, boss-shaped, hook-shaped, drop-shaped, At least one kind of protrusions including striated, scatter-like, jagged, beaded, wrinkled, terraced, burr-like, and continuous spiral protrusions.

Preferably, multiple protrusions can be arranged around the circumference; preferably, the ends of the protrusions face upward, that is, towards the top of the auxiliary component, so that the anal sinus and nearby mucous membranes can be wiped to the greatest extent.

Certainly, the protrusions of the above shapes may also be two types of protrusions with their ends pointing up and their ends facing down, arranged in a staggered up and down and/or other staggered manner.

Further, a dimple is provided at the upper position of the protruding body with the free end upward and/or a dimple is provided at the lower position of the protruding body with the free end downward. When rotating, the dimples arranged above the protruding body with the free end upward and/or below the protruding body with the free end downward can accommodate feces and inflammatory secretions that are scraped off by the protruding body and remain on the anal sinus and rectal mucosa. It can more effectively remove feces, inflammatory secretions, foreign bodies, etc.

In order to ensure that the feces, inflammatory secretions, and foreign objects contained in the dimples due to the wiping operation will not be displaced when the device moves up and down and/or rotates, there are secondary dimples and/or multiple dimples in the dimples. A raised, better retention scraped feces and so on.

Further, the outer surface of the auxiliary component is provided with a protrusion conforming to the anal sinus, and the dimple is arranged on the protrusion conforming to the anal sinus; the protrusion conforming to the anal sinus means that it can be inserted into and Fully filling the interior of the hollow anal sinus makes it easier to scrape off the residual feces, inflammatory secretions, foreign bodies, etc. in the anal sinus, and promptly accommodate them in the lacuna and move them out of the body.

In order to make full use of the medicine in the medicine storage part, the medicine channel is arranged between the outer surface of the rod-shaped part and the inner surface of the auxiliary part, the top of the auxiliary part covers the top of the rod-shaped part, and the drug outlet of the medicine channel is arranged on the auxiliary part.

In order to deliver fluid substances that can be used for lubrication, cleaning, and treatment, it also includes a drug storage part for storing drugs. The drug outlet of the drug storage part is connected with the drug inlet of the drug channel; the drug storage part can store liquid water or drug solution, even Paste and gel have the functions of lubricating, antibacterial, cleaning, and promoting wound healing.

In order to facilitate the insertion of the device into the rectum and limit the length of the insertion into the rectum, the bottom end area of the rod-shaped part and/or the bottom end area of the auxiliary part is provided with a radially extending part, which is pressed against the anus during use, and the device above the radially extending part can be into the rectum.

In order to display the length of the device entering the rectum, the outer surface of the device is provided with scale lines that increase in value from the top end of the auxiliary part to the bottom end of the auxiliary part.

The beneficial effects of the present invention are:

1. The auxiliary parts of the present invention are provided with pits that can accommodate drugs and/or fecal matter and protrusions that can penetrate into the anal sinus and stimulate the rectal mucosa. During use, feces, inflammatory secretions, foreign matter, etc. can be fully wiped and removed , can stimulate the anal canal and rectal mucosa, stimulate the sense of fullness and fullness reflex of the rectum, and stimulate the nerve endings in the anal cushion area such as tension sensory receptor Pacinian corpuscle, friction sensory receptor Genital corpuscle, pressure sensory receptor Golgi-Mazzoni body, promote defecation; help to eliminate constipation caused by anal sinus inflammation, help prevent and treat anal sinusitis after diarrhea, help prevent, care and treat anorectal diseases such as hemorrhoids and anal fissures, and help Help patients with diarrhea to clean up the feces, inflammatory secretions, foreign bodies, etc. inside the anal sinus and on the rectal mucosa in time to avoid blocking the opening of the anal glands and causing inflammation.

2. The drug channel of the present invention is set between the outer surface of the rod-shaped part and the inner surface of the auxiliary part and/or on the auxiliary part. The diameter of the drug channel is smaller than that of the existing drug delivery channels such as Kaisailu, and the drug residue is less , the drug in the drug storage part can fully act on the anal sinus and rectal mucosa of the human body; and the drug outlet of the drug channel is closer to the anal canal and rectal mucosa. Mucous membrane, it is easier to remove feces, inflammatory secretions, foreign bodies, etc. remaining in the anal sinus and rectal mucosa; when the drug is squeezed through the drug channel, the weaker area on the auxiliary part will undergo wave-like changes due to impact pressure expansion, and local swelling It can also stimulate the anal canal and rectal mucosa, stimulate the sense of fullness and reflex in the rectum, and promote defecation.

3. It can be used as daily cleaning and maintenance of the anal canal and can train the sensitivity of the anal canal's "sampling reflex", "defecation reflex" and other physiological functions.

Description of drawings

The accompanying drawings that do not limit the present invention are as follows:

Figure 1A: Schematic diagram of the anatomy of the anal canal and anal sinus;

Figure 1B: Cross-sectional view of the anal sinus;

Figure 1C: Schematic diagram of traditional products acting on the anal sinus;

Figure 1D: a schematic diagram of Embodiment 1 of the present invention;

Figure 1E: A schematic diagram of the action of Example 1 of the present invention on the anal sinus;

Figure 1F: a schematic diagram of Example 1 of the present invention entering the rectum;

Fig. 2: schematic diagram of Embodiment 2 of the present invention;

Fig. 3: the schematic diagram of embodiment 3 of the present invention;

Fig. 4A: a schematic diagram of secondary dimples provided in Example 4 of the present invention;

Figure 4B: a schematic diagram of a protrusion provided in Embodiment 4 of the present invention;

Figure 5: a schematic diagram of Embodiment 5 of the present invention;

Figure 6: a schematic diagram of Embodiment 6 of the present invention;

Detailed ways

Embodiments that do not limit the present invention are as follows:

Example 1:

Firstly, the position, brief structure of the human anal sinus and the current situation of the use of traditional Kaisailu are explained. As shown in Figures 1A, 1B, and 1C, the opening A5 of the anal gland A4 is blocked by feces or foreign objects B; the traditional opening of the anal canal A1 from the anus A0 The drug F delivered by the rods of Selu cannot remove the feces or foreign objects B located in the anal sinus A3 of the dentate line A2.

As shown in the accompanying drawings of Figure 1D-1F series, embodiment 1 of the present invention comprises: rod-shaped part 1, auxiliary part 2 and the drug channel 3 that is used to deliver medicine, and drug channel 3 is provided with at least one drug inlet 31 and at least one A drug outlet 32, the auxiliary part 2 fits on the rod-shaped part 1, at least the hardness of the material of the auxiliary part 2 that enters the rectum is lower than that of the rod-shaped part 1, and the auxiliary part 2 is provided with the opening direction and the rod-shaped part. 1 Dimples 20 that have the same and/or intersecting longitudinal axes, including line-shaped, drop-shaped, scatter-shaped, jagged, beaded, ring-shaped, wrinkled, terraced, bag-shaped, and continuous spiral-shaped dimples 20 At least one dimple 20 for containing medicine and/or fecal matter. The dimple 20 is provided with at least one opening 201. The dimple 20 can be a simple depression, or a pocket with an opening formed by partially covering the depression, It can also be a bag shape formed by partially covering the non-recessed area of the auxiliary part; the auxiliary part 2 can be made of medical-grade thermoplastic elastomer TPE material or silicone rubber material in one piece, which not only has good biocompatibility, but also has good texture Softer and more comfortable in contact with the human body; rod-shaped parts and auxiliary parts, each part can be composed of one part or multiple parts; in order to facilitate the insertion of the device into the rectum, the length of the device inserted into the rectum is limited, and the rod The region of the bottom end 14 of the shaped part and/or the region of the bottom end 24 of the auxiliary part is provided with a radially extending part 24a, which abuts against the anus during use, and the part of the device above the radially extending part 24a can enter the rectum; The scale line S whose value increases from the top 23 to the bottom end 24 of the auxiliary part shows the length of the device entering the rectum; in addition, as shown in Figure 1D, the device also includes a drug storage part 4 for storing medicine, and the medicine storage part 4 The outlet 41 communicates with the drug inlet 31 of the drug channel 3, and the drug storage part 4 and the rod-shaped part 1 can be embedded and tightly connected or screwed. In this embodiment, the drug storage part 4 is fan-shaped and made by blow molding , the drug storage part 4 has a drug storage cavity with a certain volume, internally stores rectal lubricants such as glycerin, paraffin oil, and mannitol, and can also be ointment, emulsion, etc., which have the functions of lubricating the anorectal wall, softening feces, promoting defecation, antibacterial, anesthesia, and supplementing probiotics. When in use, insert the device into the rectum of the human body through the anus, squeeze the drug storage part 4 so that the internal drug enters the drug channel 3 through the drug outlet 41, and then enters the rectum from the drug outlet 32 of the drug channel 3, In and out multiple operations, apply medicine to the anal canal wall and rectal wall of the human body, stimulate and massage the anorectal wall, and play a role in promoting defecation and drug-related effects.

In order to stimulate and massage the anorectal wall more effectively, and remove feces, inflammatory secretions, and foreign objects trapped inside the anal sinus, the outer surface 21 of the auxiliary component is also equipped with cord-shaped, nail-shaped, boss-shaped, hook-shaped, At least one protrusion 211 including drop-shaped, striated, scatter-shaped, jagged, beaded, wrinkled, terraced, burr-shaped, and continuous spiral protrusions 211; as shown in Figures 1D-1F , in this embodiment, the protrusions 211 and the dimples 20 are both hook-shaped, and the dimples 20 are arranged between two adjacent protrusions 211. It helps to eliminate constipation caused by anal sinus inflammation, helps prevent and treat anal sinusitis after diarrhea, and helps patients with diarrhea to treat it in time. Clean up the remaining feces, inflammatory secretions, foreign bodies, etc. inside the anal sinus and on the rectal mucosa to avoid blocking the opening of the anal gland and causing inflammation; the lacuna 20 can also accommodate a certain amount of lubricating, cleaning, and antibacterial drugs.

When in use, as shown in Figure 1E, when the device enters the anal canal A1 of the human body, the protrusion 211 on the outer surface 21 of the auxiliary part penetrates into the anal sinus to closely contact and wipe the anal sinus mucous membrane to block the feces of the anal gland opening A5 Or the foreign body B is wiped away; at this time, continue to move forward, as shown in Figure 1F, the feces or foreign matter scraped off in the anal sinus enter the interior of the lacuna 20, and are taken out of the body together with the device, so as to avoid being removed from the body by the protrusion 211 The scraped feces in one anal sinus are pushed into other anal sinuses. This device stimulates the anal canal and rectal mucosa, stimulates the sense of fullness and inflation reflex of the rectum, and at the same time can effectively remove feces and inflammatory secretions. , foreign matter, etc., are fully wiped and removed.

Example 2:

The difference from the previous embodiment is that, as shown in Figure 2, a dimple 20 is provided above the protruding body 211a with the free end upward, and a dimple 20 is provided at the lower position of the protruding body 211b with the free end downward. When the device enters the rectum of the human body and moves upward, downward, and/or rotates, the dimples arranged above the protruding body 211a with the free end upward and/or below the protruding body 211b with the free end downward can accommodate the anal Feces, inflammatory secretions, and foreign objects in the sinus and on the rectal mucosa, and the feces or foreign objects scraped off in the anal sinus enter the interior of the lacuna 20 and are taken out of the body together with the device, which is more effective and fully wiped to remove feces and inflammation secretions, foreign bodies, etc.

Example 3:

The difference from Embodiment 1 is that, as shown in FIG. 3 , the dimple 20 is a pocket formed by partially covering the non-recessed area of the auxiliary part, which is easy to be molded. The opening 201 faces the top end 23 of the auxiliary part and the opening 201 faces the auxiliary part. The dimples 20 at the bottom end 24 are arranged in sequence. The dimples 20 can not only accommodate feces, inflammatory secretions, foreign objects, etc. that are wiped away when the device moves upward or downward, but also can closely contact and stimulate the anal canal and rectal mucosa to promote defecation .

Example 4:

The difference from Example 1 is that, as shown in Figure 4A, there are secondary dimples 201 in the dimple 20, and as shown in Figure 4B, there are a plurality of columnar protrusions 202 in the dimple 20, and the thin and soft feces of patients with diarrhea tend to stay in the Bacteria and viruses carried inside the anal sinus or on the rectal mucosa are likely to cause intestinal infection and inflammation, and the secondary lacuna 201 and/or protrusion 202 can ensure that the feces and inflammation contained in the lacuna 20 are wiped and removed. Secretion, foreign matter, etc. will not shift when the device moves up and down and/or rotates, and the feces or foreign matter scraped off in the anal sinus enter the interior of the pouch 20 and are taken out of the body together with the device to avoid being The feces scraped off by the protruding body 211 from a certain anal sinus are pushed into other anal sinuses, which can be cleaned out of the anal canal more effectively and stably.

Example 5:

The difference from Embodiment 1 is that, as shown in Figure 5, the outer surface 21 of the auxiliary part is provided with a protrusion 212 conforming to the anal sinus, and the dimple 20 is arranged on the protrusion 212 conforming to the anal sinus, and the protrusion 212 conforming to the anal sinus The conformable protrusion 212 means that it can penetrate into and fully fill the hollow anal sinus, and the feces or foreign objects scraped off in the anal sinus enter the interior of the lacuna 20 and are taken out of the body together with the device, making it easier to displace the anal sinus Scrape off the residual feces, inflammatory secretions, foreign bodies, etc. in the anal sinus, more effectively clean the anal sinus, stimulate the defecation receptors at the bottom of the anal sinus, and promote defecation.

Embodiment 6:

The difference from Embodiment 5 is that, as shown in Figure 6, the drug passage 3 is arranged between the outer surface 11 of the rod-shaped part and the inner surface 22 of the auxiliary part, specifically formed by a channel-like gap between the two, and the top end 23 of the auxiliary part covers The top 13 of the rod-shaped part and the drug outlet 32 of the drug passage 3 are arranged on the auxiliary part 2, the diameter of the drug channel is small, the drug residue is small, and the drug in the drug storage part can fully act on the anal sinus and rectal mucosa of the human body; and The drug outlet of the drug channel is closer to the anal canal and rectal mucosa. When the drug is extruded, it has a certain flushing speed, which can more effectively flush the anal canal and rectal mucosa, and wash away feces, inflammatory secretions, foreign objects, etc. remaining in the anal sinus ; When the drug is squeezed through the drug channel, the weaker area on the auxiliary part expands in waves due to the impact pressure, and the local expansion can stimulate the anal canal and rectal mucosa, stimulate the sense of fullness and fullness reflex of the rectum, and promote defecation .

Various schemes of the present invention can repeatedly enter and exit the anus when used, increasing the frequency of wiping can play a more sufficient wiping and cleaning effect; wiping and stimulating the anal sinus A3 in patients with constipation can promote gland secretion, exert self-lubricating effect, and can stimulate defecation reflex ;The thin soft feces left in the anal sinus and on the rectal mucosa after defecation in patients with diarrhea are wiped and removed, and then accommodated in the lacuna and removed from the body together with the device, similar to brushing teeth as a routine oral cleaning, even if there is no anorectal disease. Wipe after defecation every day , Cleaning the anal sinus and rectal mucosa will also play a role in preventing anorectal diseases such as anal sinusitis.

Claims

A rectal drug delivery device, comprising a rod-shaped part (1) with a top end and a bottom end, an auxiliary part (2) and a drug channel (3) for delivering drugs, the drug channel (3) being provided with at least one drug inlet (31) And at least one drug outlet (32), it is characterized in that: the auxiliary part (2) fits on the rod-shaped part (1), at least the hardness of the auxiliary part (2) entering the rectum is lower than that of the rod-shaped part (1), the auxiliary part (2) is provided with a dimple (20) capable of containing medication and/or fecal matter, and the dimple (20) is provided with at least one opening (201).
The rectal drug delivery device according to claim 1, characterized in that: said auxiliary part (2) is provided with openings in the same direction as and/or intersecting with the longitudinal axis of the rod-shaped part (1), including line-shaped, drop-shaped , Scattered, jagged, beaded, ring-shaped, wrinkled, terraced, bag-shaped, continuous spiral lacuna (20) including at least one kind of dimple (20).
The rectal drug delivery device according to claim 1, characterized in that: the auxiliary part (2) is also equipped with a cord-shaped, nail-shaped, boss-shaped, hook-shaped, drop-shaped, stripe-shaped, scattered At least one kind of protrusion (211) including dot shape, jagged shape, bead shape, wrinkle shape, terrace shape, burr shape and continuous spiral protrusion body (211).
The rectal drug delivery device according to claim 3, characterized in that: a recess (20) is provided above the protruding body (211a) with the free end upward and/or below the protruding body (211b) with the free end downward The position is provided with a dimple (20).
The rectal drug delivery device according to claim 3, characterized in that: the outer surface (21) of the auxiliary component is also provided with a protrusion (212) conforming to the anal sinus, and the dimple (20) is arranged on the anal sinus conforming on the protrusion (212).
The rectal drug delivery device according to claim 3, characterized in that: the dimple (20) is arranged between two adjacent protrusions (211).
The rectal drug delivery device according to claim 1, characterized in that: the dimple (20) is provided with a secondary dimple (201) and/or a plurality of protrusions (202).
The rectal drug delivery device according to claim 1, characterized in that: the drug channel (3) is arranged between the outer surface (11) of the rod-shaped part and the inner surface (22) of the auxiliary part and/or is arranged on the auxiliary part (2) up.
The rectal drug delivery device according to claim 1, characterized in that: it also includes a drug storage part (4) for storing drugs, a drug outlet (41) of the drug storage part (4) and a drug inlet of the drug channel (3) (31) are connected.
The rectal drug delivery device according to claim 1, characterized in that: the outer surface of the device is provided with scale lines (S) that increase in value from the top end (23) of the auxiliary part to the bottom end (24) of the auxiliary part, to indicate that the device is in The length of the rectum.