Synergistic drug delivery device for natural orifice

Abstract

A natural orifice synergistic drug delivery device comprises a slender hard rod-shaped body (11) and a soft body (12) wrapping the rod-shaped body (11), the rod-shaped body (11) is provided with a rod-shaped body head part (111) entering a natural orifice opening during use, a rod-shaped body middle part (112) and a rod-shaped body tail part (113) located outside the natural orifice opening during use, and the drug delivery device (1) is provided with a liquid injection port (101), a liquid passage (10) and a radial liquid outlet (102). The head area of the soft body (12) is provided with a hollow flexible wrapping part (125) and / or a suction cup part (127), the internal space (1250) of the flexible wrapping part can at least contain a part of the tail part (23) of the solid suppository, and during use, the solid suppository (2) is firstly inserted into the flexible wrapping part (125) and / or adsorbed on the suction cup part (127), and then the administration device is slowly inserted into a natural orifice through an opening of the natural orifice. And then a liquid medicament is injected through the liquid injection port, the dosing device is pulled out of the opening of the natural cavity, and the solid suppository is retained in the natural cavity.

Description

Technical Field

[0001] The invention relates to a natural cavity coordinated drug delivery device, belonging to the technical field of medical device products. Background Art

[0002] Drug delivery through natural cavities is a commonly used medical method, such as anal canal, rectal delivery, and vaginal delivery. Solid suppositories and liquid medicines are usually used successively during drug delivery. The drug ingredients in solid suppositories are gradually released, while liquid medicines can take effect quickly and have a cleansing effect at the same time. When treating hemorrhoids and other diseases around the anal canal, a solid suppository is usually first clamped with tweezers and placed into the dilated part of the rectum through the anal canal, and then an irrigation tube is inserted to release the liquid medicine. This requires two entries into the anus, which causes great damage to the mucosa and is time-consuming and labor-intensive. In order to prevent local stenosis after anal canal surgery, the anal canal usually needs to be dilated daily, and corresponding dilators need to be inserted. Vaginal delivery also usually involves first using liquid medicine to flush the vagina and then inserting a solid suppository into the vaginal vault. The drug delivery process is a two-step operation, resulting in low medical efficiency and significant patient discomfort. Summary of the Invention

[0003] The present invention provides a natural cavity coordinated drug delivery device, which completes the two operations of inserting a solid suppository and releasing a liquid medicine during a single entry into a natural cavity, while preventing the hard part of the drug delivery device from damaging the mucosa. When a natural cavity needs to be expanded, the expansion is completed by filling an expandable capsule attached to the drug delivery device.

[0004] The object of the present invention is achieved like this:

[0005] A natural cavity cooperative drug delivery device comprises: a slender hard rod-shaped body, a soft body wrapped outside the rod-shaped body, the rod-shaped body having a head portion that enters the natural cavity opening when in use, a middle portion, and a tail portion that is located outside the natural cavity opening when in use, the drug delivery device is provided with a liquid injection port, a liquid passage, and a liquid radial outlet, the head region of the soft body is provided with a hollow flexible wrapping portion and / or a suction cup portion, the internal space of the flexible wrapping portion can accommodate at least a part of the tail of a solid suppository, when in use, the solid suppository is first inserted into the flexible wrapping portion and / or adsorbed on the suction cup portion, and then the drug delivery device is slowly inserted into the natural cavity through the natural cavity opening, and then the liquid medicine is injected through the liquid injection port, and then the drug delivery device is pulled out of the natural cavity opening, and the solid suppository is retained in the natural cavity.

[0006] The soft body includes a soft body head, a flexible wrapping part at the distal end of the soft body head, a soft body middle part, and a soft body tail; a radial liquid outlet is opened in the area below the flexible wrapping part. The present invention realizes the coordinated delivery of solid suppositories and liquid medicines, shortens the operation time, improves the operation efficiency and avoids mucosal damage to the greatest extent; the injection port of the applicator is set at the tail of the rod-shaped body, and the external liquid medicine or pure water enters the liquid passage of the applicator through the injection cavity at the tail of the rod-shaped body.

[0007] One structure is that the liquid injection port of the drug dispenser is arranged at the tail of the rod-shaped body, and the hollow part inside the rod-shaped body constitutes a liquid passage.

[0008] Another structure is that the liquid injection port of the drug dispenser is arranged at the tail of the rod-shaped body or the tail of the soft body, and the gap between the outer surface of the rod-shaped body and the inner surface of the soft body constitutes a liquid passage.

[0009] In order to exert the driving effect of the liquid, the hollow part inside the rod-shaped body constitutes a liquid passage. The liquid passage has multiple liquid radial outlets in the head area of ​​the applicator. The hollow part inside the rod-shaped body passes through the head of the rod-shaped body to form a top opening of the liquid passage, and the top opening of the liquid passage is connected to the liquid passage.

[0010] A structure of a flexible wrapping portion is that the flexible wrapping portion at the distal end of the soft body head is folded toward the tail of the rod-shaped body, the inner surface of the flexible wrapping portion is turned outward, and the free end of the flexible wrapping portion is directed toward the tail of the rod-shaped body; when used, the tail of the solid suppository can be wrapped by pushing upward, and the inner surface of the flexible wrapping portion contacts and constrains the outer surface of the tail of the solid suppository.

[0011] A comprehensive solution is that the top end of the rod-shaped body head is covered with a soft body membrane portion or a soft body suction cup portion, so that the top end of the rod-shaped body head does not directly contact the tail end surface of the solid suppository; the soft body suction cup portion can be used in combination with the wrapping portion, or can be used alone to absorb and fix the tail end surface of the solid suppository.

[0012] In order to enhance the restraint capability of the solid suppository, the rod-shaped body head is connected with a rod-shaped body covering portion for covering the solid suppository.

[0013] One solution for forming a liquid passage is that the rod-shaped body is provided with at least one longitudinal rib, and the gaps between the longitudinal rib and the rod-shaped body and / or between the longitudinal ribs are wrapped by a soft body to together form a liquid passage; the liquid injection port is connected to the liquid passage through an outwardly open connecting hole on the tail of the rod-shaped body; the outwardly open connecting hole is located at the starting part of the longitudinal rib, the longitudinal rib starts at the distal end of the tail of the rod-shaped body, and the connecting hole is between the longitudinal ribs; under this solution, the applicator has multiple liquid passages to ensure circumferential uniformity when the drug solution is released; the "distal end" mentioned in the present invention refers to the direction away from the liquid injection port of the applicator and toward the head of the rod-shaped body.

[0014] Furthermore, an expandable sac is provided between the liquid injection port and the liquid outlet of the applicator. When the inner cavity of the expandable sac is filled with fluid, the radial support force generated by the expansion of the outer boundary expands the natural cavity.

[0015] In order to make the solid suppository easily detachable from the flexible wrapping portion, the applicator may further be provided with a push rod, which enters through the liquid passage and contacts the tail end surface of the solid suppository, generating a thrust to push the solid suppository away from the flexible wrapping portion.

[0016] The beneficial effects of the present invention are:

[0017] 1. When the applicator passes through the opening of a natural cavity, the hard rod-shaped body does not directly contact the mucosal tissue, but the soft body covering it contacts the mucosa, reducing damage to the mucosa.

[0018] 2. The flexible wrapping part on the soft body of the applicator wraps the tail of the solid suppository, protecting the mucosal tissue while allowing it to move forward stably, preventing the solid suppository from falling off when inserted into the natural cavity, and ensuring that the solid suppository is placed in the target position.

[0019] 3. The suction cup portion on the soft body of the applicator can absorb the tail end surface of the solid suppository and fix it axially without increasing the maximum external dimensions of the applicator. When passing through the opening of the natural cavity and advancing in the natural cavity, the solid suppository is prevented from falling off while minimizing damage to the mucosa.

[0020] 4. The combination of the suction cup part and the flexible wrapping part on the soft body of the applicator makes the solid suppository move more stably in the natural cavity.

[0021] 5. The multiple radial liquid outlets on the suction cup portion or below the flexible wrapping portion of the applicator can release liquid medicine to the natural cavity mucosal tissue at any time, achieving the purpose of coordinated administration of solid suppositories and liquid medicines in one operation.

[0022] 6. Before, during, and after administration, the expandable capsule can be filled according to the needs of the disease to radially expand the natural cavity, thereby improving local blood supply, promoting lymphatic return, promoting drug absorption, preventing stenosis, evenly coating liquid medicine, and promoting mucosal absorption of liquid medicine.

[0023] 7. The top opening of the liquid passage can play a hydraulic pushing role for the liquid medicine, which helps to separate the solid suppository from the applicator when it reaches the target position.

[0024] 8. The flexible wrapping portion that is easily deformed and expanded is suitable for solid suppositories with various outer diameters. The everted flexible wrapping portion is easier to fully combine with the solid suppository.

[0025] The operation steps are significantly simplified, the two-step drug administration operation is reduced to a coordinated one step, and the three-step expansion operation is reduced to one step, avoiding secondary and tertiary mucosal tissue damage when medical devices enter the natural cavity opening, significantly saving medical operation time, protecting the fragile mucosa of the affected area, and reducing treatment costs. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] The accompanying drawings which do not limit the present invention are as follows:

[0027] Figure 1A : Schematic diagram of the structure of embodiment 1

[0028] Figure 1B: Cross-sectional view of Example 1, arrows indicate the direction of liquid medicine flow

[0029] Figure 1C : Example 1 Schematic cross-sectional view of entering the anal canal C and rectal cavity R

[0030] Figure 1D : Schematic cross-sectional view of the solid suppository of Example 1 retained in the rectal cavity R

[0031] Figure 1E : Cross-sectional view of Example 1

[0032] Figure 2A : Schematic cross-section of Example 2

[0033] Figure 2B : Schematic diagram of embodiment 2

[0034] Figure 3A : Schematic cross-section of Example 3

[0035] Figure 3B : Schematic diagram of the rod-shaped body of Example 3

[0036] Figure 3C : Schematic cross-section of the push rod of Example 3

[0037] Figure 4A : Schematic diagram of the rod-shaped body of Example 4

[0038] Figure 4B : Partial cross-sectional view of the applicator of Example 4

[0039] Figure 5A : Schematic cross-section of Example 5

[0040] Figure 5B : Partial cross-sectional view of Example 5

[0041] Figure 6A : Partial cross-sectional view of Example 6

[0042] Figure 6B : Partial three-dimensional schematic diagram of Example 6

[0043] Figure 7A : Partial cross-sectional view of Example 7

[0044] Figure 7B : Partial cross-sectional schematic diagram of Example 7

[0045] Figure 7C : A partial cross-sectional diagram of a new structure of Example 7

[0046] Figure 8A : Schematic diagram of a partial cross-section of the inflatable bladder 13 and its surroundings in Example 8

[0047] Figure 8B : Schematic diagram of embodiment 8 DETAILED DESCRIPTION

[0048] The embodiments of the present invention are not limited to the following:

[0049] Example 1:

[0050] like Figures 1A-1E As shown, a natural cavity coordinated drug delivery device (hereinafter referred to as the drug delivery device) includes: an elongated hard rod-shaped body 11, which can be molded from a medical polymer material such as polypropylene and polyamide, and a flexible body 12 wrapped around the rod-shaped body 11. The flexible body 12 includes a flexible body head 121, a flexible wrapping portion 125 at the distal end of the flexible body head 121, a flexible body middle portion 122, and a flexible body tail 123. The flexible body 12 can be made of a flexible material such as silicone rubber, latex, or thermoplastic elastomer; Figure 1B The rod-shaped body 11 has a rod-shaped head 111 that enters the natural cavity when in use, a rod-shaped middle part 112 and a rod-shaped tail 113 that is located outside the opening of the natural cavity when in use. The applicator 1 is provided with a liquid injection port 101, a liquid passage 10 and a radial liquid outlet 102. The radial liquid outlet 102 is opened in the area below the flexible wrapping part 125. In this example, the liquid injection port 101 is set in the hollow rod-shaped tail 113, which is a hollow tail opening to the outside; multiple radial liquid outlets 102 are formed by connecting the radial openings on the rod-shaped head 111 and the soft body head 121. The radial liquid outlet 102 refers to the liquid medicine or flushing water that can directly contact the natural cavity mucosa radially after flowing out of the liquid outlet 102; the hollow part inside the rod-shaped body 11 constitutes the liquid passage 10 of the applicator 1.

[0051] like Figure 1A As shown, the solid suppository 2 to be delivered using the applicator 1 is in the shape of a bullet head, and is composed of a rounded blunt head 21, a middle portion 22, and a tail 23 that are connected as one body. The tail end surface 231 of the solid suppository 2 contacts the top end 1111 of the head of the rod-shaped body 11 during use. The solid suppository can carry antibiotics such as metronidazole, traditional Chinese medicine ingredients, various hormones, non-steroidal anti-inflammatory drugs, hemostatic drugs, interferon, etc. The head area of ​​the soft body 12 is provided with a hollow flexible wrapping portion 125. The internal space 1250 of the flexible wrapping portion 125 can accommodate at least a portion of the tail 23 of the solid suppository. Figure 1B When in use, first insert the solid suppository 2 into the flexible wrapping portion 125 so that the top end 1111 of the rod-shaped body rests against the tail end surface 231 of the solid suppository 2. The flexible wrapping portion 125 circumferentially constrains the tail end 23 of the solid suppository 2 to prevent the solid suppository 2 from swinging left and right and falling. Figure 1CThen, the applicator 1 is slowly inserted into the natural cavity (i.e., the anal canal C and the rectal cavity R) through the natural cavity opening A (in this case, the anus), and then a syringe or the like (not shown) is used to inject external liquid medicine or pure water into the liquid passage 10 of the applicator 1 through the liquid injection port 101 through the liquid injection cavity 1130 of the rod-shaped tail 113. The liquid medicine enters the anal canal C through the radial liquid outlet 102 and is coated on the anal canal mucosa to play a corresponding role. Then, the applicator 1 is pulled out of the natural cavity opening, and the stretched anal canal C is closed to prevent the solid suppository 2 from following the applicator. When the medicine dispenser 1 is withdrawn, the solid suppository 2 remains in the rectal cavity R and gradually releases the corresponding medicine. In addition, because the flexible wrapping portion 125 of the flexible body 12 only covers the tail portion 23 of the solid suppository, a large area of ​​the solid suppository 2 is located outside the medicine dispenser 1, and the solid suppository 2 is difficult to be brought out when the medicine dispenser 1 is withdrawn. In specific applications, the inner surface 1251 of the flexible wrapping portion can also not interfere with the outer surface of the solid suppository 2. When the medicine dispenser 1 is withdrawn, no significant friction resistance is generated between the inner surface of the flexible wrapping portion and the outer surface of the solid suppository, and the solid suppository 2 will not be brought out.

[0052] The present invention realizes the coordinated administration of the solid suppository 2 and the liquid medicine, shortens the operation time, improves the operation efficiency and avoids the mucosal damage to the greatest extent.

[0053] Example 2:

[0054] like Figure 2A 、 Figure 2B As shown, the flexible body 12 of this embodiment does not completely cover the rod-shaped body 11, but only covers the portion of the rod-shaped body 11 that may enter the natural cavity during use, that is, the rod-shaped body head 111 and the entire or partial rod-shaped body middle portion 112, and does not cover the rod-shaped body tail 113, thereby saving material costs. At the same time, the hard rod-shaped body head top 1111 does not directly contact the solid suppository 2, but is isolated from the solid suppository 2 by the flexible wrapping portion 125 of the flexible body 12. That is, the rod-shaped body head top 1111 is covered with the flexible body membrane portion 126, thereby preventing the hard rod-shaped body head top 1111 from damaging the relatively fragile solid suppository 2, thereby ensuring the integrity of the solid suppository 2 after entering the natural cavity.

[0055] Example 3:

[0056] like Figure 3A 、 Figure 3BAs shown, the biggest difference from Example 1 is that the hollow portion within the rod-shaped body 11 constitutes a liquid passage 10. The liquid passage 10 has multiple radial liquid outlets 102 in the head region of the applicator. The hollow portion within the rod-shaped body 11 passes through the rod-shaped body head 111 to form a liquid passage top opening 1110. The liquid passage top opening 1110 is connected to the liquid passage 10. During use, in addition to the annular rod-shaped body head top 1111 resisting the tail end surface 231 of the solid suppository 2, the liquid medication can also actively push the solid suppository 2 out of the flexible wrapping portion cavity 1250 and into the natural cavity through the liquid passage top opening 1110.

[0057] like Figure 3C As shown, the push rod G further includes a push rod G that enters the liquid passage 10 through the liquid injection port 101. The top end of the push rod G contacts the rear end surface 231 of the solid suppository 2 through the top opening 1110 of the liquid passage. External force drives the push rod G to push the solid suppository 2 out of the inner cavity 1250 of the flexible wrapping portion and into the natural cavity. The push rod G can be provided with a push rod handle G1 for easy gripping by the user. The large area of ​​the push rod handle G1 can also prevent the push rod G from completely entering the liquid passage 10.

[0058] Example 4:

[0059] like Figure 4A 、 Figure 4B As shown, in this embodiment, the rod-shaped body 11 is not provided with a liquid passage 10. A plurality of longitudinal ribs 1120 are provided on the rod-shaped body head 111 and the rod-shaped body middle portion 112. The gaps between the longitudinal ribs 1120 and the rod-shaped body 1 and between the longitudinal ribs 1120 are wrapped by the soft body 12 to form the liquid passage 10. The liquid injection port 101 is connected to the liquid passage 10 through an outwardly open communication hole 1121 on the rod-shaped body tail 113. The outwardly open communication hole 1121 is located on the longitudinal rib 112. 0, the longitudinal ribs 1120 start from the distal end of the rod-shaped tail 113, and the communicating holes 1121 are between the longitudinal ribs 1120; under this scheme, the applicator 1 has multiple liquid passages 10, and the cross-sectional area of ​​the liquid passages 10 is increased to ensure the smoothness and circumferential uniformity of the drug solution during release; the longitudinal ribs 1120 can increase the strength of the applicator 1, and it is not easy to bend during use; the "distal end" mentioned in the present invention refers to the direction away from the liquid injection port 101 of the applicator and toward the rod-shaped head 111.

[0060] Example 5:

[0061] like Figure 5A 、 Figure 5BAs shown, considering that heavy or axially long solid suppositories 2 are often used clinically, the flexible wrapping portion 125 can flexibly contact the mucosa to minimize mucosal damage, but its restraining effect on the above-mentioned specific solid suppositories 2 is insufficient. In this example, a hard rod-shaped body covering portion 1112 is provided at the distal end of the hard rod-shaped head 111. The rod-shaped body covering portion 1112 is integrally connected to the rod-shaped body head 111 to cover the solid suppository 2. Compared with the flexible wrapping portion 125 provided thereon, the rod-shaped body covering portion 1112 is stronger and has a sufficient restraining effect on the specific solid suppository 2, ensuring that the solid suppository 2 is delivered to the target location and preventing the solid suppository 2 from falling off when being pushed into the natural cavity.

[0062] In this example, Figure 5A The liquid injection port 101 of the applicator 1 is shown to be arranged at the tail 113 of the rod-shaped body or the tail 123 of the flexible body. The gap between the outer surface 114 of the rod-shaped body and the inner surface 124 of the flexible body constitutes a liquid passage 10. This gap can be in a closed state and is only opened when the liquid medicine enters. Figure 5A The liquid passage is in a closed state, i.e., the outer surface 114 of the rod body is in close contact with the inner surface 124 of the flexible body. As in the previous embodiment, the liquid injection port 101 is connected to the liquid passage 10 through the outwardly open communication hole 1121 on the tail portion 113 of the rod body (not shown in this embodiment). Figure 5B The middle rod-shaped body 11 is hollow inside to form a hollow liquid passage 10. A push rod G (not shown) can enter through this liquid passage 10 to push the solid suppository 2 out of the inner cavity 1250 of the flexible wrapping portion. Liquid medicine can also actively push the solid suppository 2 out of the inner cavity 1250 of the flexible wrapping portion through the top opening 1110 of this liquid passage.

[0063] Example 6:

[0064] like Figure 6A 、 Figure 6B As shown, considering that the solid suppository 2 is difficult to insert into the flexible wrapping portion 125 when a thin-walled flexible wrapping portion 125 is used, the flexible wrapping portion 125 at the distal end of the soft body head 121 of this embodiment is folded toward the rod-shaped body tail 113, and the inner surface 1251 of the flexible wrapping portion 125 is turned outward, with the free end 1252 of the flexible wrapping portion 125 facing the rod-shaped body tail 113. During use, the solid suppository 2 is first placed on the bottom end 1253 of the flexible wrapping portion, and then the turned-out flexible wrapping portion 125 is pushed toward the solid suppository 2 and folded to the wrapped state described in the drawings of the aforementioned embodiment. The outer diameter of the thin-walled flexible wrapping portion 125 does not increase significantly after wrapping the solid suppository 2, making it easier for the suppository to enter through the natural cavity opening. In addition, the material of the flexible wrapping portion 125 is easy to deform and expand, so solid suppositories 2 with different outer diameters within a certain range can be wrapped therein.

[0065] This example Figure 6AThe top openings 1110 of the applicator 1 are shown. When the solid suppository 2 is delivered to the right position, the liquid medicine can actively push the solid suppository 2 out of the inner cavity of the flexible wrapping part and into the natural cavity through the top openings 1110 of the liquid passage.

[0066] Example 7:

[0067] like Figure 7A 、 Figure 7B As shown, a downwardly concave suction cup portion 127 is provided at the distal center of the soft body head 121, and a circumferentially distributed suction cup lower gap 128 is left below the suction cup portion 127; Figure 7B The solid suppository 2 is placed in the flexible wrapping portion 125 so that the rear end surface 231 of the solid suppository 2 is pressed against the suction cup portion 127, so that the air in the suction cup portion 127 is partially or completely squeezed out and the solid suppository 2 is adsorbed on the suction cup portion 127, thereby maintaining the stability of the solid suppository 2 during the natural cavity advancement process; the gap 128 below the suction cup can facilitate the downward deformation of the suction cup portion 127, thereby facilitating the expulsion of the air in the suction cup portion 127 and forming a negative pressure; the adsorption force generated by the negative pressure is only to stabilize the solid suppository 2 and prevent it from swinging left and right. After the solid suppository 2 is delivered to the target position and exits the applicator 1, the stretched mucosal tissue retracts. The resistance of the retracted mucosal tissue to the solid suppository 2 with a larger diameter is greater than the adsorption effect of the suction cup portion 127, so that the solid suppository 2 is separated from the suction cup portion 127 of the applicator 1.

[0068] A variation of this idea is Figure 7C In order to facilitate the release of the continuous adsorption of the solid suppository 2 after the solid suppository 2 is delivered to the target position, a suction cup hole 1270 is opened in the central area of ​​the suction cup portion 127. The bottom of the suction cup hole 1270 is blocked by the top end 1111 of the rod-shaped head. When it is necessary to release the adsorption of the solid suppository 2, the rod-shaped body 11 can be pulled outside the body to cause the top end 1111 of the rod-shaped head and the suction cup portion 127 of the soft body 12 to move relative to each other. That is, the top end 1111 of the rod-shaped head moves downward, releasing the blockage of the suction cup hole 1270, and gas or liquid enters the depression of the suction cup portion 127 through the suction cup hole 1270, thereby releasing the adsorption of the solid suppository 2.

[0069] The soft body suction cup portion 127 can be used in combination with the flexible wrapping portion 125, or can be used alone to absorb and fix the tail end surface 231 of the solid suppository.

[0070] Example 8:

[0071] like Figure 8A 、 Figure 8BAs shown, in order to simultaneously meet the clinical need to expand the natural cavity, an inflatable capsule 13 is provided between the liquid injection port 101 and the liquid outlet 102 of the applicator 1. After the inner cavity 130 of the inflatable capsule is filled with fluid, the radial support force generated by the expansion of the outer boundary expands the natural cavity; the inflatable capsule 13 can be made of compliant materials such as silicone rubber, latex, thermoplastic elastomer, etc., and can also be made of semi-compliant or non-compliant materials such as polyamide, block polyether amide, etc. The inflatable sac 13 is sleeved on the outside of the soft body 12 and is composed of a sac connecting part 131 and a sac expanding part 132. The sac connecting parts 131 located at both ends of the inflatable sac 13 are sealed and connected to the outer surface of the soft body 12. The annular gap between the inner surface of the sac expanding part 132 located in the middle of the inflatable sac 13 and the outer surface of the soft body 12 wrapped therein is the inflatable sac inner cavity 130. When in use, the syringe (not shown) is inserted into the one-way valve 134, and the fluid in the syringe enters the inflatable sac inner cavity 130 through the sac connecting tube 133, the sac connecting tube opening 1330 and the sac passage 1220 and the sac passage opening 1221 located in the soft body 12. The sac expanding part 132 is expanded and deformed outward under the internal fluid pressure, and the natural cavity is radially expanded; the sac passage 1220 can also be located in the rod-shaped body 11.

[0072] When the applicator 1 of the present invention passes through the opening of a natural cavity, the hard rod-shaped body 11 does not directly contact the mucosal tissue. Instead, the soft body covering it contacts the mucosa, thereby reducing damage to the mucosa. The flexible wrapping portion 125 on the soft body of the applicator wraps the tail 23 of the solid suppository, protecting the mucosal tissue while allowing it to move forward stably, preventing the solid suppository 2 from falling off when inserted into the natural cavity, and ensuring that the solid suppository 2 is placed in the target position.

[0073] The suction cup portion 127 on the soft body of the applicator can absorb the tail end surface 231 of the solid suppository and fix it axially without increasing the maximum external dimensions of the applicator. When the solid suppository 2 passes through the opening of the natural cavity and advances in the natural cavity, it prevents the solid suppository 2 from falling off while minimizing damage to the mucosa. The suction cup portion 127 on the soft body of the applicator is used in combination with the flexible wrapping portion 125, so that the solid suppository 2 advances in the natural cavity more stably.

[0074] The suction cup portion 127 on the soft body 12 of the applicator or the multiple radial liquid outlets 102 below the flexible wrapping portion 125 can release liquid medicine to the natural cavity mucosal tissue at any time, achieving the purpose of coordinated administration of the solid suppository 2 and the liquid medicine during one operation.

[0075] Before, during, and after administration, the expandable capsule can be filled according to the needs of the disease to radially expand the natural cavity, thereby improving local blood supply, promoting lymphatic return, promoting drug absorption, preventing stenosis, evenly coating liquid medicine, and promoting mucosal absorption of liquid medicine.

[0076] The present invention significantly simplifies the clinical operation steps, reducing the two-step drug administration operation to a coordinated one step, and reducing the three-step operation of joint expansion to one step, avoiding secondary and tertiary mucosal tissue damage when medical instruments enter the natural cavity opening, significantly saving medical operation time, protecting the fragile mucosa of the affected area, and reducing treatment costs.

[0077] One parameter setting is: the outer diameter of the main body of the applicator 1 for rectal use, excluding the flexible wrapping portion 125 and part of the liquid injection port 101, is between 2 mm and 8 mm, and the length is between 35 mm and 180 mm; the outer diameter of the main body of the applicator 1 for vaginal use is between 5 mm and 38 mm, and the length is between 65 mm and 280 mm; the size-related parameters can be individually customized according to the concept of the present invention.

[0078] In addition to the digestive tract and reproductive tract, the present invention can also be applied to drug delivery and synchronous expansion of other natural cavities such as the nasal cavity and the ear canal.

Claims

1. A natural cavity coordinated drug delivery device (1), comprising: The invention relates to a slender hard rod-shaped body (11), a soft body (12) wrapped around the rod-shaped body (11), the rod-shaped body (11) having a rod-shaped body head (111) that enters the natural cavity opening when in use, a rod-shaped body middle part (112) and a rod-shaped body tail (113) that is located outside the natural cavity opening when in use, characterized in that the applicator (1) is provided with a liquid injection port (101), a liquid passage (10) and a radial liquid outlet (102), and the head area of ​​the soft body (12) is provided with a hollow flexible wrapping part (111). 25) and / or the suction cup portion (127), the internal space (1250) of the flexible wrapping portion (125) can accommodate at least a part of the tail portion (23) of the solid suppository. When in use, the solid suppository (2) is first inserted into the flexible wrapping portion (125) and / or adsorbed on the suction cup portion (127), and then the applicator (1) is slowly inserted into the natural cavity through the opening of the natural cavity, and then the liquid medicine is injected through the injection port (101), and then the applicator (1) is pulled out of the natural cavity opening, and the solid suppository (2) is retained in the natural cavity.

2. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: The liquid injection port (101) of the drug delivery device (1) is arranged at the rod-shaped tail (113), and external liquid medicine or purified water enters the liquid passage (10) of the drug delivery device (1) through the liquid injection cavity (1130) of the rod-shaped tail (113).

3. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: The liquid injection port (101) of the drug dispenser (1) is arranged at the tail portion (113) of the rod-shaped body, and the hollow portion inside the rod-shaped body (11) constitutes a liquid passage (10).

4. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: The liquid injection port (101) of the applicator (1) is arranged at the rod-shaped body tail (113) or the soft body tail (123), and the gap between the rod-shaped outer surface (114) and the soft body inner surface (124) forms a liquid passage (10).

5. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: The hollow portion in the rod-shaped body (11) constitutes a liquid passage (10), and the liquid passage (10) is provided with a plurality of radial liquid outlets (102) in the head region of the applicator. The hollow portion in the rod-shaped body (11) passes through the rod-shaped body head (111) and forms a liquid passage top opening (1110) at the top end of the rod-shaped body head (111), and the liquid passage top opening (1110) is communicated with the liquid passage (10).

6. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: The flexible wrapping portion (125) at the distal end of the soft body head (121) is folded toward the rod-shaped body tail (113), the inner surface (1251) of the flexible wrapping portion is turned outward, and the free end (1252) of the flexible wrapping portion (125) faces the rod-shaped body tail (113).

7. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: The top end (1111) of the rod-shaped body head (111) is covered with a soft body membrane portion (126) or a soft body suction cup portion (127), and the top end (1111) of the rod-shaped body head (111) does not directly contact the tail end surface (231) of the solid suppository (2).

8. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: The rod-shaped body head (111) is connected to a rod-shaped body covering portion (1112) for covering the solid suppository (2).

9. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: At least one longitudinal rib (1120) is provided on the rod-shaped body (11); the gap between the longitudinal rib (1120) and the rod-shaped body (11) and / or the gap between the longitudinal rib (1120) and the longitudinal rib (1120) is wrapped by the soft body (12) to form a liquid passage (10); the liquid injection port (101) is connected to the liquid passage (10) through an outwardly open communication hole (1121) on the tail of the rod-shaped body (113).

10. The natural cavity coordinated drug delivery device (1) according to claim 1, characterized in that: An expandable sac (13) is provided between the liquid injection port (101) and the liquid outlet (102) of the applicator (1). When the inner cavity (130) of the expandable sac (13) is filled with fluid, the radial supporting force generated by the expansion expands the natural cavity.

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