Medicine suppository and dosing device

Abstract

The drug suppository enters a natural cavity for use through a natural cavity opening, the drug suppository is provided with a blunt head part (21), a middle part (22) and a tail part (23), the head part (21) of the drug suppository firstly enters the natural cavity opening when the drug suppository is used, and the drug suppository (2) is provided with various structures which can be conveniently combined with and / or synergistically act with the drug administration device (1); the drug suppository and the dosing device can be synchronously pushed after being combined, the two steps of operation of placing the drug suppository and releasing the liquid medicament are completed in the process of entering a natural cavity at a time, and meanwhile the hard part of the dosing device is prevented from damaging mucosa.

Description

Technical Field

[0001] The utility model relates to a medicine suppository and a drug delivery device, belonging to the technical field of medical equipment products. Background Art

[0002] Drug administration through natural cavities is a commonly used medical method, such as anal canal, rectal administration, vaginal administration, etc. Solid or gel suppositories and liquid medicines are usually used successively. The drug ingredients in the suppositories are gradually released, while the liquid medicines can take effect quickly and have a cleaning effect at the same time. When treating hemorrhoids and other diseases around the anal canal, the drug suppository is usually clamped with tweezers and placed into the dilated part of the rectum through the anal canal, and then a flushing tube is inserted to release the liquid medicine. It needs to enter the anus twice, which causes great damage to the mucosa and is time-consuming and labor-intensive. In addition, in order to prevent local stenosis after anal canal surgery, it is usually necessary to dilate the anal canal every day and insert corresponding dilator devices. Vaginal administration is also usually performed by flushing the vagina with liquid medicine and then inserting the drug suppository into the vaginal vault. Both operations are two or even three steps, with low medical efficiency and significant patient discomfort. Summary of the invention

[0003] The utility model provides a drug suppository and a drug delivery device. The drug delivery device is provided with a receiving body matched with the drug suppository. After the receiving body and the drug suppository are combined, they can be pushed forward synchronously. The two-step operations of inserting the drug suppository and releasing the liquid medicine are completed in the process of entering the natural cavity once. At the same time, the hard part of the drug delivery device is prevented from damaging the mucosa. The natural cavity that needs to be expanded is completed by filling the expandable capsule attached to the drug delivery device.

[0004] The purpose of the utility model is achieved in this way:

[0005] A drug suppository is used by entering a natural cavity through a natural cavity opening, and has a blunt head, a middle part, and a tail. When used, the head of the drug suppository first enters the opening of the natural cavity, and the drug suppository is provided with one or more of the following structures that facilitate combination and / or synergistic action with a drug delivery device: the drug suppository is provided with a hole or multiple small holes opening at the tail end surface of the tail and facing the head of the drug suppository; the drug suppository is provided with a hole penetrating the head and tail of the drug suppository, and the upper opening of the hole is located on the surface of the head of the drug suppository; the drug suppository is provided with a hole penetrating the head and tail of the drug suppository, which is composed of a hole opening at the tail and a section extending upward from the hole, and the upper opening of the hole of the section extending upward from the hole is located on the surface of the head of the drug suppository; the drug suppository is provided with an annular hole opening at the tail end surface of the tail, and a columnar body is embedded in the annular hole; the drug suppository is provided with a columnar protrusion extending from the tail end surface of the tail or a polygonal boss with a height less than the columnar protrusion; the drug suppository is provided with a protrusion extending from the outer surface The drug suppository is provided with at least one transverse, oblique or longitudinal groove extending inward from the outer surface; the drug suppository is provided with at least one discontinuous or continuous annular protrusion extending outward from the outer surface; the drug suppository is provided with at least one discontinuous or continuous longitudinal protrusion extending outward from the outer surface; the drug suppository is provided with a local discontinuous or continuous circumferential depression extending inward from the outer surface; the drug suppository is composed of a drug suppository mother part and one or more drug suppository sub-parts, at least the handle part of the drug suppository sub-part protruding downward can be placed in the inner cavity of the drug suppository mother part for synchronous advancement; the drug suppository is composed of a drug suppository mother part and one or more drug suppository sub-parts, the inner cavity of the drug suppository mother part accommodating the drug suppository sub-part is a through cavity, the upper opening of the cavity is connected with the inner cavity of the drug suppository sub-part, when in use, the liquid medicine entering the inner cavity of the drug suppository mother part flows through the inner cavity of the drug suppository sub-part and then enters the natural cavity through the upper opening of the cavity, and the upper opening of the cavity is located on the head surface of the drug suppository sub-part.

[0006] The cavity can be divided into a petal-shaped cavity, a polygonal cavity, a circular cavity, and an annular cavity according to its cross-sectional shape. A drug suppository can have multiple cavities.

[0007] A drug delivery device for assembling and delivering the drug suppository described in claim 1, comprising: a slender hard rod-shaped body, a soft body wrapped outside the rod-shaped body, the rod-shaped body having a rod-shaped body head entering the opening of a natural cavity when in use, a rod-shaped body middle part and a rod-shaped body tail located outside the opening of the natural cavity when in use, the drug delivery device having a liquid injection port, a liquid passage and a radial liquid outlet, a receiving body being provided in the head region of the soft body and / or the head region of the rod-shaped body, which is combined with and / or synergistic with the corresponding structure of the drug suppository, and when in use, the drug suppository is first combined with the receiving body on the drug delivery device as a whole, and then the drug delivery device is slowly inserted into the natural cavity through the opening of the natural cavity, and then the liquid medicine is injected through the liquid injection port, and finally the drug delivery device is pulled out of the opening of the natural cavity, and the drug suppository is retained in the natural cavity.

[0008] The applicator receiving body includes a flexible body receiving body and / or a rod-shaped body receiving body; wherein the flexible body receiving body is a hollow flexible wrapping part and / or a flexible protrusion located at the distal end of the flexible body head, which is used to combine with the corresponding structure of the drug suppository; and the rod-shaped body receiving body is a rod-shaped body extension part and / or a rod-shaped body covering part located at the distal end of the rod-shaped body head.

[0009] The combination of the drug suppository and the applicator means that the two are pre-contacted and assembled when in use, and are combined into a synchronously displaceable whole. At least when the long axis of the applicator is horizontal to the ground, the drug suppository will not fall off the applicator due to gravity. When the operator holds the applicator and inserts it into the opening of the natural cavity, the drug suppository enters the opening of the natural cavity first or synchronously with the top structure of the head of the applicator. The combination strength of the drug suppository and the applicator after being assembled as a whole first ensures the stability of the drug suppository when it moves forward in the natural cavity, and the drug suppository is easy to separate from the applicator when the applicator moves backward.

[0010] The flexible wrapping portion and the rod-shaped body covering portion are used to conformally accommodate the columnar protrusion extending from the tail end surface of the tail of the drug suppository or the polygonal boss with a height less than the columnar protrusion; they are also used to accommodate the annular bulge and longitudinal bulge of the drug suppository from the outer surface outward. The best is that the inner surface of the flexible wrapping portion and the rod-shaped body covering portion is also provided with a concave structure matching the annular bulge and the longitudinal bulge; the internal space of the flexible wrapping portion and the internal space of the rod-shaped body covering portion can accommodate at least a part of the tail of the drug suppository, and can also accommodate a part of the mother part and / or the daughter part of the drug suppository; and they are integrated with the drug suppository through conformal accommodation.

[0011] The flexible protrusion and the rod-shaped extension are integrated with the drug suppository by conformingly embedding into the internal cavity, annular cavity, longitudinal groove, spiral depression, and circumferential depression of the drug suppository; they can also be embedded in the through cavity of the mother part of the drug suppository or simultaneously embedded in the inner cavity of the sub-part of the drug suppository, and are integrated with the drug suppository by conformingly embedding, so that the drug suppository can be placed in the natural cavity through the drive of the drug delivery device.

[0012] The synergistic effect between the drug suppository and the drug delivery device refers to: the liquid passage and the radial liquid outlet structure on the drug delivery device make the release of the liquid medicine coordinated with the insertion of the drug suppository; after the top opening of the liquid passage of the drug delivery device is connected with the cavity penetrating the head and tail of the drug suppository, the liquid medicine is released from the opening on the cavity on the surface of the drug suppository head, and coordinated with the synchronous insertion of the drug suppository; the top structure on the drug delivery device, especially the flexible protrusion and the rod-shaped body extension, can realize a local "pushing out" action through relative displacement operation, so that the drug suppository falls off the drug delivery device when the drug delivery device is in a static state as a whole, and the synergistic effect of the separation of the two is generated; it also includes a drug suppository that combines a drug suppository mother part and a drug suppository sub-part at the same time, and the drug suppository mother part and the drug suppository sub-part are inserted into the natural cavity at the same time or successively, so that the drug suppository mother part and the drug suppository sub-part with different pharmacological components cooperate in the aspect of drug combination treatment; wherein, the drug suppository sub-part can be pushed out a certain distance by the "push rod" inserted in the liquid passage of the drug delivery device, and then the drug suppository mother part is separated from the drug delivery device.

[0013] 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 provided in the area below the flexible wrapping part, and the utility model realizes the coordinated administration of drug 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 drug delivery device is arranged at the tail of the rod-shaped body, and the external liquid medicine or pure water enters the liquid passage of the drug delivery device through the injection cavity at the tail of the rod-shaped body.

[0014] One structure is that the liquid injection port of the drug delivery device is arranged at the tail of the rod-shaped body, and the hollow part inside the rod-shaped body constitutes a liquid passage.

[0015] Another structure is that the liquid injection port of the drug delivery device 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.

[0016] In order to exert the driving effect of the liquid, the hollow part inside the rod-shaped body constitutes a liquid passage, and the liquid passage has multiple radial liquid outlets in the head area of ​​the applicator. The hollow part inside the rod-shaped body penetrates 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.

[0017] 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 faces the tail of the rod-shaped body; when used, the tail of the drug suppository can be wrapped by pushing it upward, and the inner surface of the flexible wrapping portion contacts and constrains the outer surface of the tail of the drug suppository.

[0018] A comprehensive solution is that the top of the rod-shaped body head is covered with a soft body membrane, and the top of the hard rod-shaped body head does not directly contact the tail end surface of the drug suppository, thereby preventing the drug suppository from being broken and damaged.

[0019] In order to enhance the restraining ability of the drug suppository, the rod-shaped body head is connected with a rod-shaped body covering part for covering the drug suppository.

[0020] A solution for forming a liquid passage is that at least one longitudinal rib is provided at the rod-shaped body head and the middle part of the rod-shaped body, 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 jointly 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 drug delivery device has multiple liquid passages to ensure circumferential uniformity when the drug solution is released; the "distal end" described in the utility model refers to the direction away from the liquid injection port of the drug delivery device and toward the head of the rod-shaped body.

[0021] Furthermore, an expandable sac is provided between the injection port and the liquid outlet of the drug delivery device. When the inner cavity of the expandable sac is filled with fluid, the radial supporting force generated by the expansion of the outer boundary will expand the natural cavity. At the same time, it can also prevent the liquid medicine from flowing out of the natural cavity opening during release and affecting the therapeutic effect.

[0022] The beneficial effects of the utility model are:

[0023] 1. The drug suppository is provided with a structure that is convenient for combination and synergistic effect with the drug delivery device, so as to facilitate integrated entry into the natural cavity.

[0024] 2. The main and sub-parts of the suppository are designed to be separated and used in combination with a drug delivery device, so that two or more drugs can be delivered at one time.

[0025] 3. Liquid medicine can enter the cavity that runs through the head and tail of the drug suppository and be released from the opening of the cavity, achieving the effect of simultaneous administration of liquid medicine and solid or gel drug suppository.

[0026] 4. When the applicator passes through the opening of the natural cavity, the hard rod-shaped body does not directly contact the mucosal tissue, but the soft body covering it contacts the mucosa, thereby reducing damage to the mucosa.

[0027] 5. The flexible wrapping part on the soft body of the applicator wraps the tail of the drug suppository, protecting the mucosal tissue while allowing it to move forward stably, preventing the drug suppository from falling off when inserted into the natural cavity, and ensuring that the drug suppository is placed in the target position.

[0028] 6. The extended part of the rod-shaped body of the drug delivery device is embedded in the cavity of the drug suppository to fix the drug suppository axially without increasing the maximum external dimension of the drug delivery device. When the drug suppository passes through the opening of the natural cavity and moves forward in the natural cavity, the drug suppository is prevented from falling off and the damage to the mucosa is minimized.

[0029] 7. The flexible protrusion and the flexible wrapping part on the soft body of the applicator are used in combination, so that the drug suppository can move forward more stably in the natural cavity.

[0030] 8. The multiple radial liquid outlets below the flexible wrapping part on the soft body of the drug delivery device can release liquid medicine to the natural cavity mucosal tissue at any time, achieving the purpose of coordinated drug delivery of suppositories and liquid medicines in one operation.

[0031] 9. 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 preventing the outflow of liquid medicine during administration, improving local blood supply, promoting lymphatic return, promoting drug absorption, preventing stenosis, evenly coating liquid medicine, and promoting mucosal absorption of liquid medicine.

[0032] 10. The top opening of the liquid passage can exert the hydraulic force of the liquid medicine, which helps to separate the medicine suppository from the drug delivery device when the medicine suppository reaches the target position.

[0033] The operation steps are significantly simplified, and the two-step administration operation of clinical solid or gel-state drug suppositories and liquid medicines is reduced to a coordinated one-step, and the three-step operation of joint expansion is reduced to one step, thereby avoiding secondary and tertiary mucosal tissue damage caused by medical instruments entering 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

[0034] The accompanying drawings which do not limit the present invention are as follows:

[0035] Figure 1A : Schematic diagram of the structure of Example 1

[0036] Figure 1B : Cross-sectional view of Example 1, arrows indicate the flow direction of liquid medicine

[0037] Figure 1C : Example 1: Cross-sectional view of entering the anal canal C and the rectal cavity R

[0038] Figure 1D : Cross-sectional view of the drug suppository indwelling in the rectal cavity R of Example 1

[0039] Figure 1E : Cross-sectional view of Example 1

[0040] Figure 1F: Schematic diagram of different structural drug suppositories in Example 1

[0041] Figure 2A : Cross-sectional view of Example 2

[0042] Figure 2B : A cross-sectional view of another embodiment of Example 2

[0043] Figure 2C : A three-dimensional schematic diagram of Example 2

[0044] Figure 3A : Cross-sectional view of Example 3

[0045] Figure 3B : A cross-sectional view of another embodiment 3

[0046] Figure 4A : Cross-sectional view of Example 4

[0047] Figure 4B : Component sectional view of embodiment 4

[0048] Figure 5A : Cross-sectional view of Example 5

[0049] Figure 5B : Another state cross-sectional view of embodiment 5

[0050] Figure 5C : Partial stereoscopic schematic diagram of Example 5

[0051] Fig. 6A : Partial stereoscopic schematic diagram of Example 6

[0052] Figure 6B : Example 6 Different three-dimensional schematic diagrams of drug suppositories

[0053] Figure 6C : Example 6 More different three-dimensional schematic diagrams of drug suppositories

[0054] Fig. 7A : Stereoscopic and cross-sectional views of the pharmaceutical suppository of Example 7

[0055] Figure 7B : Partial cross-sectional view of Example 7

[0056] Fig. 8A : Cross-sectional view of Example 8

[0057] Figure 8B : A three-dimensional schematic diagram and a partial cross-sectional view of the expandable bladder 13 of Example 8 DETAILED DESCRIPTION

[0058] The embodiments of the present invention are not limited to the following:

[0059] Embodiment 1:

[0060] like Figures 1A-1F As shown, a drug suppository 2 is used by entering the natural cavity through the opening of the natural cavity, and has a rounded head 21, a middle part 22, and a tail 23 that are connected as a whole. When used, the head 21 of the drug suppository first enters the opening of the natural cavity. The drug suppository 2 is provided with a structure that combines and / or cooperates with the applicator 1. The inside of the drug suppository 2 is provided with a cavity 232 that opens at the tail end surface 231 of the tail 23 and faces the head 21 of the drug suppository.

[0061] The applicator 1 for delivering the above-mentioned drug suppository 2 comprises: a slender hard rod-shaped body 11, which can be made of medical polymer molding such as polypropylene and polyamide, and a soft body 12 wrapped outside the rod-shaped body 11, and the soft body 12 comprises a soft body head 121, a flexible wrapping part 125 at the distal end of the soft body head 121, a soft body middle part 122, and a soft body tail 123; the soft body 12 can be made of flexible materials such as silicone rubber, latex, and thermoplastic elastomer; Figure 1B The rod-shaped body 11 is provided with 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. 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 arranged in the hollow rod-shaped body tail 113, and the hollow rod-shaped body tail 113 is open to the outside; a plurality of radial liquid outlets 102 are formed by connecting the radial openings on the rod-shaped body head 111 and the flexible body head 121. The radial liquid outlet 102 refers to the liquid agent 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.

[0062] A rod-shaped extension 1113 is provided at the distal end of the rod-shaped head 111 of the drug delivery device 1. The rod-shaped extension 1113 serves as a receiving body combined with the drug suppository 2. Specifically, when in use, the rod-shaped extension 1113 is embedded in the cavity 232 of the drug suppository 2. The two are combined with conformal sizes to form a synchronously displaceable whole. At least when the drug delivery device 1 is horizontally suspended along the long axis, the drug suppository 2 will not fall off the drug delivery device due to gravity. When the operator holds the drug delivery device 1 and inserts it into the opening of the natural cavity, the drug suppository 2 enters the opening of the natural cavity first. The strength of the combination of the drug suppository 2 and the drug delivery device 1 after being assembled as one body first ensures stability when moving forward in the natural cavity, and the drug suppository is easily separated from the drug delivery device when the drug delivery device retreats.

[0063] like Figure 1AAs shown, the drug suppository 2 to be delivered by the applicator 1 is in the shape of a bullet head. The drug suppository can carry antibiotics such as metronidazole, Chinese medicine ingredients, various hormones, non-steroidal anti-inflammatory drugs, hemostatic drugs, interferon, etc.; the soft body head 121 area is provided with a hollow flexible wrapping portion 125, and the internal space 1250 of the flexible wrapping portion 125 can accommodate at least a part of the tail 23 of the drug suppository, such as Figure 1B When in use, the drug suppository 2 is first inserted into the flexible wrapping portion 125. The flexible wrapping portion 125 circumferentially constrains the tail portion 23 of the drug suppository 2 to prevent the drug suppository 2 from swinging left and right and falling. At the same time, the rod-shaped body extension portion 1113 is embedded in the cavity 232 of the drug suppository 2 to make the combination of the two more stable. The top end 1111 of the rod-shaped body head is adjacent to or in contact with the bottom end surface of the cavity 232; Figure 1C Then, 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 (the anus in this example), 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 injection port 101 through the injection cavity 1130 of the rod-shaped body 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. At this time, the stretched anal canal C is closed to prevent the drug suppository 2 from following the applicator 1 to withdraw. The drug suppository 2 is retained in the rectal cavity R and gradually releases the corresponding drug. In addition, because the flexible wrapping portion 125 of the flexible body 12 only covers the tail portion 23 of the drug suppository, a large area of ​​the drug suppository 2 is located outside the applicator 1, and the drug suppository 2 is difficult to be taken out when the applicator 1 is withdrawn, especially when the anal canal C is stretched open and quickly closed during withdrawal, the drug suppository 2 is prevented from falling out. In specific applications, the inner surface of the flexible wrapping portion may not be in interference contact with the outer surface of the drug suppository 2, and no significant friction resistance will be generated when the applicator 1 is withdrawn, and the drug suppository 2 will not be taken out.

[0064] Figure 1E A drug delivery device 1 without a flexible wrapping portion 125 is shown, and the outer diameter is reduced, making it easier to enter a narrow natural cavity.

[0065] like Figure 1F As shown, the hollow space on the drug suppository 2 of the present invention can be distinguished by its cross-sectional shape into various shapes such as a petal-shaped hollow space 236, a polygonal hollow space 237, a circular hollow space 233, an annular hollow space 235 (with a columnar body 234 embedded therein), etc., and the corresponding receiving body on the applicator 1 has a conformable shape embedded in these hollow spaces, and a drug suppository 2 can be provided with multiple hollow spaces.

[0066] The utility model realizes the coordinated administration of the drug suppository 2 and the liquid medicine, shortens the operation time, improves the operation efficiency and avoids the mucosal damage to the greatest extent.

[0067] Embodiment 2:

[0068] like Figure 2A , Figure 2C As shown, the soft body 12 of this example does not completely cover the rod-shaped body 11, and only covers the part of the rod-shaped body 11 that may enter the natural cavity when in use, that is, the rod-shaped body head 111 and the rod-shaped body middle part 112 are all or partially covered, and the rod-shaped body tail 113 is not covered, which saves material costs. At the same time, the hard top 1111 of the rod-shaped body head does not directly contact the drug suppository 2, but is isolated by the flexible wrapping part 125, and the flexible protrusion 127 at the distal end of the soft body head 121 is embedded in the cavity 232 of the drug suppository 2, so as to avoid the hard top 1111 of the rod-shaped body head from damaging the relatively fragile drug suppository 2, thereby ensuring the integrity of the drug suppository 2 after entering the natural cavity.

[0069] In order to protect the relatively fragile drug suppository 2 from being damaged by the hard rod-shaped head top 1111 and also to improve the bonding strength of the receiving body, Figure 2B Another specific structure is shown, in which the top end 1111 of the rod-shaped body head is nested in the soft body membrane part 126 at the distal end of the soft body head 121.

[0070] Embodiment 3:

[0071] like Figure 3A As shown, the drug suppository 2 is provided with a columnar protrusion 238 extending downward from the tail end surface 231 of the drug suppository tail 23, and the columnar protrusion 238 is embedded in the receiving body at the distal end of the soft body head 121 of the applicator, that is, the flexible wrapping part 125, and the columnar protrusion 238 is located in the inner cavity 1250 of the flexible wrapping part. In this scheme, the outer diameter of the flexible wrapping part 125 is not larger than the outer diameter of the drug suppository 2, and no additional resistance is generated when entering the natural cavity; the hollow part in the rod-shaped body 11 constitutes a liquid passage 10, and the liquid passage 10 is provided with multiple openings in the head area of ​​the applicator. The hollow part in the rod-shaped body 11 penetrates the rod-shaped body head 111 to form a top opening 1110 of the liquid passage, and the top opening 1110 of the liquid passage is connected with the liquid passage 10. When in use, in addition to the resistance effect of the annular top 1111 of the rod-shaped body head on the tail end surface 231 of the drug suppository, the liquid drug can also actively push the bottom end surface 2381 of the columnar protrusion 238 of the drug suppository 2 through the top opening 1110 of the liquid passage, so as to cause the drug suppository 2 to separate from the inner cavity 1250 of the flexible wrapping part and enter the natural cavity.

[0072] In order to strengthen the restraint on the columnar protrusion 238 of the drug suppository 2, that is, to increase the firmness or strength of the drug delivery device and the drug suppository after being combined, a thinner rod-shaped body covering portion 1112 is provided inside the flexible wrapping portion 125, such as Figure 3B shown.

[0073] Embodiment 4:

[0074] like Figure 4A , Figure 4B As shown, the difference from Example 1 is that the rod-shaped body 11 of this example does not have a liquid passage 10 inside, and the rod-shaped body 11 is provided with a plurality of longitudinal ribs 1120, and the gaps between the longitudinal ribs 1120 and the rod-shaped body 11 and between the longitudinal ribs 1120 are wrapped by the soft body 12 to form the liquid passage 10 together; the injection port 101 is connected to the liquid passage 10 through an outwardly open communicating hole 1121 on the rod-shaped body tail 113; the outwardly open communicating hole 1121 is located at the starting part of the longitudinal rib 1120, the longitudinal rib 1120 starts at the distal end of the rod-shaped body tail 113, and the communicating hole 1121 is between the longitudinal ribs 1120; under this scheme, the drug delivery device 1 has a plurality of liquid passages 10, and the cross-sectional area of ​​the liquid passage 10 is increased to ensure the patency and circumferential uniformity of the drug solution when it is released; the longitudinal ribs 1120 can increase the strength of the drug delivery device 1, and it is not easy to bend during use.

[0075] In this example, the top 1111 of the rod-shaped head of the drug delivery device 1 is embedded in the drug suppository cavity 232 as a receiving body, and the flexible wrapping portion 125 at the distal end of the soft body head 121 covers the drug suppository tail 23, so that the drug suppository 2 and the drug delivery device 1 are integrated into one.

[0076] The “distal end” mentioned in the present invention refers to the direction away from the injection port 101 of the applicator and toward the rod-shaped body head 111 .

[0077] Embodiment 5:

[0078] like Figure 5A , Figure 5B , Figure 5C As shown, considering that the heavy or axially long drug suppository 2 is used clinically, the flexible wrapping part 125 can flexibly contact the mucosa to avoid mucosal damage to the greatest extent, but the restraining effect on the above-mentioned specific drug suppository 2 is insufficient. The biggest difference from Example 4 is: considering that the drug suppository 2 is difficult to insert into the flexible wrapping part 125 when a thin-walled flexible wrapping part 125 is used, the flexible wrapping part 125 at the distal end of the soft body head 121 of this example is folded toward the rod-shaped body tail 113, the inner surface 1251 of the flexible wrapping part 125 is turned outward, and the free end 1252 of the flexible wrapping part 125 faces the rod-shaped body tail 113; when used, the drug suppository 2 is first placed on the bottom end 1253 of the flexible wrapping part, and then the turned-out flexible wrapping part 125 is pushed toward the drug suppository 2, and folded to the wrapped state described in the drawings of the aforementioned embodiments. The outer diameter of the thin-walled flexible wrapping part 125 will not increase significantly after wrapping the drug suppository 2, and it is easier to enter through the natural cavity opening.

[0079] Embodiment 6:

[0080] like Fig. 6AThe drug suppository 2 is provided with a partially discontinuous or continuous spiral depression 221, and the inner surface of the flexible wrapping portion 125 of the soft body 12 of the drug delivery device as the receiving body of the drug suppository 2 is provided with a spiral protruding rib 127. When in use, the drug suppository 2 is screwed into the flexible wrapping portion 125. After being placed in the natural cavity, the mucosal tissue will clamp the drug suppository 2 to varying degrees. At this time, the drug delivery device 1 can be rotated in reverse in vitro to separate the drug suppository 2 from the flexible wrapping portion 125.

[0081] Figure 6B As shown, a drug suppository 2 on the left is provided with a partially discontinuous or continuous spiral depression 221 extending inward from the outer surface, and a columnar protrusion 238 extends from the tail end surface 231 of the tail of the drug suppository, and the applicator 1 is provided with a receiving body (omitted in the figure) that is conformably combined with it; the drug suppository 2 in the middle is provided with a hollow 232 in addition to the spiral depression 221; the composite structure is better combined with the receiving body on the applicator 1; Figure 6B The right side medicine suppository 2 shown has a rounded head and tail in the shape of a rugby ball, and is provided with a hollow structure 232, so as to facilitate the combination with the receiving body on the applicator 1 without increasing the outer diameter.

[0082] like Figure 6C , different drug suppositories 2 are shown from left to right. The outer surface of the drug suppository 2 is provided with a plurality of longitudinal grooves 222, the drug suppository 2 is provided with at least one discontinuous or continuous annular protrusion 223 extending outward from the outer surface (a polygonal boss 239 is also provided on the bottom end surface 231 of the tail portion, and a cavity 232 is provided in the polygonal boss 239), the drug suppository 2 is provided with at least one discontinuous or continuous longitudinal protrusion 224 extending outward from the outer surface (and having a cavity 232); the drug suppository 2 is provided with a local discontinuous or continuous circumferential depression 225 extending inward from the outer surface (and having a cavity 232), and the drug suppository 2 is combined with a corresponding conformable receiving body (not shown) on the applicator 1 through such structures.

[0083] Embodiment 7:

[0084] like Fig. 7A In this example, the medicine suppository 2 is provided with a hollow structure penetrating the head 21 and the tail 23 of the medicine suppository. The hollow structure is composed of a hollow 232 opening at the tail 23 and a hollow upward extension section 2321. The hollow upper opening 2322 at the farthest end of the hollow upward extension section 2321 is located on the surface of the medicine suppository head 21. The hollow upper opening 2322 can be centered or eccentrically arranged. Figure 7B The hollow rod-shaped extension 1113 is embedded in the cavity 232, and the flexible wrapping portion 125 covers the tail 23 of the drug suppository. The liquid medicine in the liquid passage 10 can enter the cavity upward extension section 2321 through the top opening 1110 of the liquid passage and then flow out through the upper opening 2322 of the cavity. The arrow indicates the direction of liquid flow; the coordinated administration of the liquid medicine and the drug suppository 2 is achieved.

[0085] Embodiment 8:

[0086] like Fig. 8A , Figure 8B In order to simultaneously meet the need for expanding the natural cavity in clinical practice, an expandable bladder 13 is provided between the liquid injection port 101 and the liquid outlet 102 of the applicator 1 in this example. After the inner cavity 130 of the expandable bladder is filled with fluid, the radial supporting force generated by the expansion of the outer boundary expands the natural cavity; the expandable bladder 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.

[0087] The inflatable bladder 13 is sleeved on the outside of the soft body 12. The inflatable bladder 13 is composed of a bladder connecting part 131 and a bladder expansion part 132. The bladder connecting parts 131 located at both ends of the inflatable bladder 13 are sealed and connected to the outer surface of the soft body 12. The annular gap between the inner surface of the bladder expansion part 132 located in the middle of the inflatable bladder 13 and the outer surface of the soft body 12 wrapped therein is the inflatable bladder inner cavity 130. When in use, a syringe (not shown) is inserted into the one-way valve 134, and the fluid in the syringe enters the inflatable bladder inner cavity 130 through the bladder connecting tube 133, the bladder connecting tube opening 1330, and the bladder passage 1220 and the bladder passage opening 1221 located in the soft body 12. The bladder expansion part 132 expands and deforms outward under the internal fluid pressure, and the natural cavity expands radially.

[0088] This example shows a drug suppository 2 different from the previous embodiment. The drug suppository 2 is composed of a drug suppository mother part 2a and a drug suppository sub-part 2b. At least the downwardly protruding handle 220 portion of the drug suppository sub-part 2b can be placed in the inner cavity 230 of the drug suppository mother part for synchronous advancement. The inner cavity 230 of the drug suppository mother part accommodating the drug suppository sub-part 2b is a through cavity. The hollow upper opening 2322 of the drug suppository 2 is connected with the inner cavity 2320 of the drug suppository sub-part. When used, the liquid medicine entering the inner cavity 230 of the drug suppository mother part flows through the inner cavity 2320 of the drug suppository sub-part and then enters the natural cavity through the hollow upper opening 2322. The hollow upper opening 2322 is located on the head surface of the drug suppository sub-part 2b. The hollow upper opening 2322 can be centrally or eccentrically arranged.

[0089] The synergistic effect between the drug suppository 2 and the drug delivery device 1 in the utility model refers to that: the liquid passage 10 and the radial liquid outlet 102 structure on the drug delivery device make the release of the liquid drug coordinated with the insertion of the drug suppository 2; after the top opening 1110 of the liquid passage of the drug delivery device is connected with the cavity 232 penetrating the head 21 and the tail 23 of the drug suppository 2, the release of the liquid drug from the opening 2322 on the surface of the cavity of the head of the drug suppository is coordinated with the synchronous insertion of the drug suppository 2; the top structure on the drug delivery device 1, especially the flexible protrusion 127 and the rod-shaped body extension 1113, can be operated by local "pushing out" to synchronize the release of the liquid drug with the insertion of the drug suppository 2 when the drug delivery device is in a static state as a whole. The drug suppository 2 is made to fall off from the drug delivery device 1, thereby generating a synergistic effect of separating the two. The drug delivery device also includes a drug suppository mother part 2a and a drug suppository sub-part 2b, which are simultaneously or successively placed into a natural cavity, so that the drug suppository mother part 2a and the drug suppository sub-part 2b with different pharmacological components cooperate with each other in terms of drug combination therapy. Among them, the drug suppository sub-part 2b can be pushed out a certain distance by a "push rod" (not shown) placed in the liquid passage of the drug delivery device, and then the drug suppository mother part 2a is separated from the drug delivery device 1. When the "push rod" is used, the widths of different parts of the inner cavity 2320 of the drug suppository sub-part should be set in steps (not shown) to facilitate the action of the "push rod".

[0090] The drug suppository 2 of the utility model is provided with a structure that is convenient for combination and synergistic action with the drug delivery device 1, so as to facilitate integrated entry into the natural cavity.

[0091] The main and sub-parts of the drug suppository are designed to be separated and combined with the drug delivery device 1, so that two or more drugs can be delivered at one time.

[0092] The liquid medicine can enter the hollows 232 penetrating the head and tail of the medicine suppository 2 and be released from the openings 2322 on the hollows, achieving the effect of synchronous administration of the liquid medicine and the solid or gel-state medicine suppository 2.

[0093] When the drug delivery device 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, but 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 drug delivery device wraps the tail 23 of the solid suppository, protecting the mucosal tissue while allowing it to move forward stably, thereby preventing the drug suppository 2 from falling off when inserted into the natural cavity, and ensuring that the drug suppository 2 is placed in the target position.

[0094] The multiple radial liquid outlets 102 below the flexible wrapping portion 125 on the soft body 12 of the applicator can release liquid medicine to the natural cavity mucosal tissue at any time, thereby achieving the purpose of coordinated administration of the drug suppository 2 and the liquid medicine in one operation.

[0095] Before, during and after drug administration, the expandable capsule 13 can be filled according to the needs of the disease to radially expand the natural cavity, thereby preventing the outflow of liquid medicine, improving local blood supply, promoting lymphatic return, promoting drug absorption, preventing stenosis, evenly coating the liquid medicine, and promoting the absorption of liquid medicine by the mucosa through pressure.

[0096] The top opening 1110 of the liquid passage can exert a hydraulic force on the liquid medicine, which helps to separate the medicine suppository 2 from the drug delivery device 1 when the medicine suppository 2 reaches the target position.

[0097] The utility model significantly simplifies the operation steps, reduces the two-step administration operation of clinical solid or gel-state drug suppositories and liquid medicines to a coordinated one-step, and reduces the three-step operation of joint expansion to one step, thereby avoiding secondary and tertiary mucosal tissue damage caused by medical instruments entering the natural cavity opening, significantly saving medical operation time, protecting the fragile mucosa of the affected area, and reducing treatment costs.

[0098] One parameter setting is: the outer diameter of the main body of the drug delivery device 1 for the rectum, excluding the flexible wrapping portion 125 and part of the injection port 101, is between 2mm-8mm, and the length is between 35mm-180mm; the outer diameter of the main body of the drug delivery device 1 for the vagina is between 5mm-38mm, and the length is between 65mm-280mm; the size-related parameters can be individually customized according to the concept of the utility model; in addition to the digestive tract and reproductive tract, the utility model can also be used for drug delivery and synchronous expansion of other natural cavities such as the nasal cavity and the ear canal.

Claims

1. A drug suppository (2) is used to enter a natural cavity through a natural cavity opening, and has a blunt head (21), a middle part (22), and a tail (23). When used, the head (21) of the drug suppository first enters the natural cavity opening, and is characterized in that: The drug suppository (2) is provided with one or more of the following structures for facilitating combination and / or synergistic action with the drug delivery device (1): The medicinal suppository (2) is provided with a cavity (232) or a plurality of small cavities (233) opening at the tail end surface (231) of the tail portion (23) and facing the head portion (21) of the medicinal suppository; The medicinal suppository (2) is provided with a cavity penetrating the head (21) and the tail (23) of the medicinal suppository, and the upper opening (2322) of the cavity is located on the surface of the head (21) of the medicinal suppository; The medicinal suppository (2) is provided with a cavity penetrating the head (21) and the tail (23) of the medicinal suppository, and is composed of a cavity (232) opening at the tail (23) and an upwardly extending cavity section (2321), wherein the upper cavity opening (2322) of the upwardly extending cavity section (2321) is located on the surface of the head (21) of the medicinal suppository; The medicinal suppository (2) is provided with an annular cavity (235) opening at the tail end surface (231) of the tail portion (23), and a columnar body (234) is embedded in the annular cavity (235); The drug suppository (2) is provided with a columnar protrusion (238) extending from the tail end surface (231) of the tail portion (23) or a polygonal boss (239) whose height is smaller than the columnar protrusion (238); The drug suppository (2) is provided with a locally discontinuous or continuous spiral depression (221) extending inward from the outer surface; The drug suppository (2) is provided with at least one transverse, oblique or longitudinal groove (222) extending inward from the outer surface; The drug suppository (2) is provided with at least one discontinuous or continuous annular protrusion (223) extending outward from the outer surface; The drug suppository (2) is provided with at least one discontinuous or continuous longitudinal protrusion (224) extending outward from the outer surface; The drug suppository (2) is provided with a partially discontinuous or continuous circumferential depression (225) extending inward from the outer surface; The drug suppository (2) is composed of a drug suppository mother part (2a) and one or more drug suppository sub-parts (2b), and at least the downwardly protruding handle part (220) of the drug suppository sub-part (2b) can be placed in the inner cavity (230) of the drug suppository mother part to facilitate synchronous advancement of the drug suppository mother part (2a) and the drug suppository sub-part (2b); The drug suppository (2) is composed of a drug suppository mother part (2a) and one or more drug suppository sub-parts (2b); the inner cavity (230) of the drug suppository mother part (2a) accommodating the drug suppository sub-parts (2b) is a through cavity, and the upper opening (2322) of the cavity is connected to the inner cavity (2320) of the drug suppository sub-part (2b).

2. A drug delivery device (1) for assembling and delivering the drug suppository (2) according to claim 1, comprising: A slender hard rod-shaped body (11) and a soft body (12) wrapped around the rod-shaped body (11). The rod-shaped body (11) is provided with a rod-shaped body head (111) that enters the opening of the natural cavity when in use, a rod-shaped body middle part (112) and a rod-shaped body tail (113) that is located outside the opening of the natural cavity when in use. The drug delivery device (1) is characterized in that 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 region of the soft body (12) and / or the head region of the rod-shaped body (111) are provided with a receiving body, and the receiving body is combined with and / or synergistic with the corresponding structure of the drug suppository (2).

3. A drug delivery device (1) according to claim 2, characterized in that: The receiving body of the drug delivery device (1) comprises a flexible body (12) receiving body and / or a rod-shaped body (11) receiving body; wherein the flexible body (12) receiving body is a hollow flexible wrapping part (125) and / or a flexible protrusion (127) located at the distal end of the flexible body head (121) for combining with the corresponding structure of the drug suppository (2); and the rod-shaped body (11) receiving body is a rod-shaped body extension part (1113) and / or a rod-shaped body covering part (1112) located at the distal end of the rod-shaped body head (111).

4. A drug delivery device (1) according to claim 2, characterized in that: The liquid injection port (101) of the drug delivery device (1) is arranged at the rod-shaped body tail (113) or the soft body tail (123), and the gap between the rod-shaped body outer surface (114) and the soft body inner surface (124) constitutes a liquid passage (10) or the liquid passage (10) is constituted by the hollow part in the rod-shaped body (11).

5. A drug delivery device (1) according to claim 2, 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) penetrates the rod-shaped body head (111) to form a top opening (1110) of the liquid passage, and the top opening (1110) of the liquid passage is connected to the liquid passage (10).

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

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

9. A drug delivery device (1) according to claim 2, characterized in that: The rod-shaped body head (111) and the rod-shaped body middle part (112) are provided with at least one longitudinal rib (1120); the gap between the longitudinal rib (1120) and the rod-shaped body (11) and / or the gap between the longitudinal ribs (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 rod-shaped body tail (113).

10. A drug delivery device (1) according to claim 2, characterized in that: An expandable sac (13) is provided between the liquid injection port (101) and the liquid outlet (102) of the drug delivery device (1). When the inner cavity (130) of the expandable sac is filled with fluid, the radial support force generated by the expansion of the outer boundary expands the natural cavity.

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