The present invention relates to a medication mixer, and in particular to a medication mixer with a medication mixing cup, dual hard ports and a soft intravenous bag.
In case of using a penicillin bottle to contain powder injection, freeze-dried powder injection or liquid injection, it needs to draw out liquid medication or water for injection in a soft intravenous bag into the penicillin bottle by an injector, until there is enough liquid medication therein; and then to shake the penicillin bottle repeatedly, till the medication in the bottle is mixed evenly. Next, the liquid medication in the penicillin bottle is extracted out into the soft intravenous bag by the injector, until the liquid medication in the bottle is all extracted.
First, the above-mentioned medication mixing process is relatively time-consuming, and strenuous and too many consumable items are spent, such as injectors. More seriously, in the above-mentioned medication mixing process, it is very easy to inject outdoor air into the penicillin bottle and the soft intravenous bag. Under common conditions, there is plenty of various dusts and germs in the air, which may cause very serious medical negligence after the dusts and germs are mixed into the liquid medication to be injected and then into a human body.
Second, as for the traditional infusion preparation, the injection is performed after the medication preparation. The medication in the penicillin bottle is pumped into the soft intravenous bag in advance, and then the medication-prepared soft intravenous bag is brought to an inpatient ward to carry out infusion to a patient. After the medication preparation, the empty penicillin bottle is put aside. A medical worker has no idea of the medication in the soft intravenous bag, the medication having no traceability. Once the medical worker makes a mistake when preparing the infusion, the consequence is unthinkable.
Third, for some special medications, for example the medication to be used immediately after prepared, the traditional medication preparation is not convenient, and various structures of medication mixers disclosed before the present patent do not solve this problem.
Finally, various structures of medication mixers disclosed before the present patent do not solve the problem of liquid leakage.
For the demand on a higher level of medical service, there is an urgent need of an infusion product which is conveniently, safely, and reliably used and has no safety hazard.
In addition, the medication mixer is welded on the soft intravenous bag. After the soft intravenous bag is filled, it needs to perform high temperature sterilization on the whole soft intravenous bag at a temperature of 115-121 degrees Celsius for 30-15 minutes, with a sterilization pressure of 0.15 MPa. Although the medication mixer and the soft intravenous bag are made of polypropylene which can withstand the temperature of 120 degrees Celsius, the material of polypropylene is inevitably softened. Additionally, the high pressure of 0.15 MPa, equivalent to the pressure of 150N per square centimeter, is fatal for the sealed medication mixing cup. First, at a temperature of 120 degrees Celsius, the medication mixing cup and the sealing membrane may have reduced mechanical strength; second, the pressure of 150N per square centimeter directly deforms the body of the medication mixing cup, stretches the sealing membrane, causes wrinkle, and damages the sealing property and the medication mixing cup.
Prior to the present invention, the terminal sterilization of the medication mixer with a sealed medication mixing cup is insurmountable; and the non-sealed medication mixing cup cannot meet the sterility requirement in use. The terminal sterilization of the soft intravenous bag is necessary and obligatory in terms of laws and regulations as well as practical security.
The present invention has an object of proposing a soft intravenous bag which is used conveniently and reliably and has no safety hazard, and its related medication mixer and ports.
According to one aspect of the embodiments of the present invention, there is provided a medication mixer, including a base, a medication mixing passage, a membrane in the medication mixing passage, and a medication mixing cup, wherein the base, the medication mixing passage, the membrane in the medication mixing passage, and the medication mixing cup are integrally formed; the medication mixing cup consists of a cup wall and a cup bottom; the medication mixer further includes a cross needle located in the medication mixing cup, the cross needle consisting of an integrated needle plate as well as an upper needle and a lower needle with hollow passages which are communicated with each other; a supporting column, a clamping ring and an elastic clamping jaw are integrally; arranged on the needle plate, wherein the supporting column is arranged at a periphery of the needle plate, for supporting and fixing the clamping ring; the elastic clamping jaw is arranged at the lower side of the clamping ring and the upper ends of the elastic clamping jaw are evenly arranged and fixed along the clamping ring, the lower ends of the elastic clamping jaw are free ends, the elastic clamping jaw inclines towards the center of the medication mixing cup from the fixed upper ends to the free ends; the lower end of the medication mixing passage penetrates through the base, with the upper ends penetrating through the cup bottom; a rubber plug is arranged in the medication mixing passage between the membrane and the cup bottom; the medication mixer further includes a sealing membrane connected at a cup opening of the medication mixing cup in a press welding way, so as to seal the medication mixing cup; the sealing membrane is an easy-to-tear membrane which can still be basically kept smooth after moist heat terminal sterilization.
Further, a limit protrusion is arranged on an inner wall of the cup wall. After the cross needle is mounted in the medication mixing cup, the needle plate is limited between the limit protrusion and the cup bottom by the limit protrusion, and cannot be taken out.
According to another aspect of the embodiments of the present invention, there is further provided a medication mixer, including a base, a medication mixing passage and a medication mixing cup which are integrally formed, and a cross needle, wherein the medication mixing cup consists of a cup wall and a cup bottom; the cross needle consists of an integrated needle plate as well as an upper needle and a lower needle with hollow passages which are communicated with each other; the lower end of the medication mixing passage penetrates through the base, with the upper end penetrating through the cup bottom, a membrane is arranged in the medication mixing passage between the base and the cup bottom, and a rubber plug is arranged in the medication mixing passage between the membrane and the cup bottom; a limit protrusion is arranged on an inner wall of the cup wall; after the cross needle is mounted in the medication mixing cup, the needle plate is limited between the limit protrusion and the cup bottom by the limit protrusion and cannot be taken out; the distance of the upper surface of the cup bottom to the lower surface of the membrane is less than a length of the lower needle; the medication mixer further includes a sealing membrane connected at a cup opening of the medication mixing cup in a press welding way, so as to seal the medication mixing cup; the sealing membrane is an easy-to-tear membrane which can still be basically kept smooth after moist heat terminal sterilization.
Further, the limit protrusion is an elastic clamping jaw, the upper ends of which are arranged uniformly and fixed along the periphery of the inner wall of the cup wall, and the lower ends of which are free ends. The elastic clamping jaw inclines towards the center of the medication mixing cup from the fixed upper ends to the free ends; the needle plate is located between the lower end and the cup bottom.
According to another aspect of the embodiments of the present invention, there is further provided a medication mixer, including a base, a medication mixing passage and a medication mixing cup which are integrally formed, and a cross needle, wherein the medication mixing cup consists of a cup wall and a cup bottom, the cross needle consists of an integrated needle plate as well as an upper needle and a lower needle with hollow passages which are communicated with each other; the lower end of the medication mixing passage penetrates through the base, with the upper end penetrating through the cup bottom, a membrane is arranged in the medication mixing passage between the base and the cup bottom, and a rubber plug is arranged in the medication mixing passage between the membrane and the cup bottom; the medication mixer further includes an elastic clamping base including a clamping ring provided with an elastic clamping jaw at the lower side, the upper ends of the elastic clamping jaw are arranged uniformly and fixed along the clamping ring, and the lower ends of the elastic clamping jaw are free ends, and the elastic clamping jaw inclines towards the center of the medication mixing cup from the fixed upper ends to the free ends; the needle plate is mounted below the elastic clamping jaw in the medication mixing cup; a limit structure is arranged on an inner wall of the cup wall, the elastic clamping base is mounted in the medication mixing cup and is limited by the limit structure; the distance of the upper surface of the cup bottom to the lower surface of the membrane is less than the length of the lower needle; the medication mixer further includes a sealing membrane connected at a cup opening of the medication mixing cup in a press welding way, so as to seal the medication mixing cup; the sealing membrane is an easy-to-tear membrane which can still be basically kept smooth after moist heat terminal sterilization.
Further, the elastic clamping base has a bottom plate, a supporting column, a clamping ring and an elastic clamping jaw which are integrally formed, wherein the supporting column is arranged at a periphery of the bottom plate, so as to support and fix the clamping ring; a central hole is arranged on the bottom plate, the lower needle penetrates through the central hole, thereby positioning the cross needle; the needle plate is located between the bottom plate and the elastic clamping jaw.
Further, an annular protrusion is arranged at the central region of the lower surface of the bottom plate, the region limited by the annular protrusion is superimposed with the central hole completely, and is arranged coaxially with the medication mixing passage; the bottom plate clings closely to the cup bottom through the annular protrusion.
Further, a piercing region is formed in the central region of the rubber plug, and is thinner than an edge region; an annular protrusion is arranged at the central region of the lower surface of the needle plate, and the piercing region is superimposed with or located in the region limited by the annular protrusion.
According to another aspect of the embodiments of the present invention, there is further provided a medication mixer with a strengthening structure, including a medication mixer; reinforcing ribs are arranged on the cup wall of the medication mixing cup, so as to enhance compressive strength of the cup wall; the reinforcing ribs are integrally arranged at an inner side of the cup wall in an up and down direction and/or a horizontal direction.
Further, the medication mixer further includes a cover plate; the cover plate is located in the cup opening; and is covered by the sealing membrane.
Further, an inner stepwise edge is arranged along the cup wall at the cup opening, the cover plate is put on the inner edge; the upper surface of the cover plate is flushed with or slightly lower than the cup opening;
the sealing membrane is hot-pressed on the upper end surface of the cup wall, thereby sealing the cup opening.
Further, the cover plate is polygonal, with a hole in the center, and the point of the upper needle is located in the hole and does not penetrate therethrough.
Further, the sealing membrane is a breathable easy-to-tear membrane with an air permeability of 5% to 35%.
Further, a metal film is plated on an upper surface of the sealing membrane.
Further, the medication mixing cup is prefilled with a certain amount of liquid before sealed by the sealing membrane, for balancing the air pressure inside and outside the medication mixing cup substantially; the liquid can be vaporized rapidly in an environment of moist heat sterilization.
Further, the lower end of the medication mixing passage is provided with an easy-breaking handle for sealing the lower end of the medication mixing passage.
Further, a convex ring or a concave groove is arranged on the upper surface of the membrane, a concave groove or a convex ring is arranged correspondingly on the lower surface of the rubber plug; the membrane is tabled with the rubber plug through the convex ring or the concave groove.
Further, an exit of the hollow passage of the upper needle is arranged on the side wall of the point of the upper needle; and/or; an exit of the hollow passage of the lower needle is arranged on the side wall of the point of the lower needle.
Further, the upper needle is coated with a layer of elastic shrink film; and/or; the lower needle is coated with a layer of elastic shrink film.
According to another aspect of the present invention, there are also provided dual hard ports with a medication mixer, including a medication mixer, one infusion passage is arranged on the base of the medication mixer at the side opposite to the medication mixing passage; and ports are arranged on the infusion passage.
According to another aspect of the embodiments of the present invention, there is further provided a soft intravenous bag, including a medication mixer; or including the above-mentioned dual hard ports; the medication mixer or the dual hard ports jointed with the soft bag by the base.
Further, the medication mixer further includes an infusion port which is arranged on the soft intravenous bag at the same side as the medication mixer, or arranged on the soft intravenous bag at the side opposite to the medication mixer.
Further, the soft intravenous bag is made of a non-PVC officinal compounding velamen.
Further, the base, the medication mixing cup and the membrane are made of medical polypropylene, preferably polypropylene R530C.
Further, the cross needle, the limit protrusion and the limit structure are made of polypropylene, preferably polypropylene P17.
1, soft intravenous bag, 2, base, 3, medication mixing cup, 3-1, cup wall, 3-2, cup bottom. 3-3, reinforcing rib, 4, elastic clamping base, 4-1, elastic clamping jaw, 4-2, annular protrusion, 4-3, central hole, 4-4, supporting column, 4-5, bottom plate, 4-6, clamping ring, 5, cross needle, 5-1, needle plate, 5-2, upper needle, 5-3, lower needle, 5-4, side hole, 5-5, needle point, 6, rubber plug, 6-1, piercing region, 6-2, convex ring, 6-3, concave groove, 7, medication mixing passage, 8, membrane, 9, penicillin bottle, 10, easy-breaking handle, 11, infusion passage, 12, cover plate, 12-1, through hole, 12-2 reinforcing ribs of the cover plate, 13, sealing membrane.
In order to make the objectives, technical solution and advantages of the present invention clearer, the present invention is further explained in detail with combination of the embodiments and with reference to the drawings. It shall be understood that the descriptions are only illustrative, but not to limit the scope of the present invention. In addition, in the following explanation, the description of the well-known structure and technology is omitted to avoid unnecessarily confusing the concepts of the present invention.
The present invention will be further explained in combination with drawings of the present invention.
As shown in the sectional view of the base 2 and the medication mixing cup 3 in
The rubber plug 6 is placed in the medication mixing passage 7, and is located above the membrane 8.
As shown in
As shown in
The medication mixing passage 7 penetrates through the base 2, and upwards extends through the cup bottom 3-2 of the medication mixing cup 3. The membrane 8 functions to avoid the direct contact of the liquid medication with the rubber plug 6, so as to ensure the complete sealing before use. Theoretically, the membrane may be located at any position in the medication mixing passage 7 below the rubber plug 6. However, if the position of the membrane 8 is too low, the lower needle 5-3 of the cross needle 5 is too long, so preferably, the membrane 8 is located below the rubber plug 6 and clings to the lower surface of the rubber plug 6.
The rubber plug 6 is placed in the medication mixing passage 7 and above the membrane 8. The rubber plug 6 functions to ensure that the liquid medication does not ooze from the medication mixing passage 7 after flowing out of the gap between the membrane 8 and the outer wall of the lower needle 5-3 after the rubber plug 6 and the membrane 8 are pierced by the lower needle 5-3. That is, the outer diameter of the rubber plug 6 is matched with the inner diameter of the medication mixing passage 7, such that the rubber plug. 6 is closely contacted with the medication mixing passage 7.
Preferably, the upper surface of the rubber plug 6 is substantially flushed with or slightly higher than the upper surface of the cup bottom 3-2. Thus, the lower surface of the elastic clamping base 4 as shown in
As a preferable technical solution, the membrane 8 is located below the rubber plug 6 and clings to the lower surface of the rubber plug 6, as shown in
After the needle plate 5-1 presses against the rubber plug 6, the rubber plug 6 and the membrane 8 provided with the concave groove 6-3 or the convex ring 6-2 which are tabled with each other can completely avoid the leakage of the liquid medication after the medication mixing.
More preferably, the lower surface of the needle plate 5-1 surrounds the root of the lower needle 5-3, and is provided with a circle of annular protrusion. After the cross needle 5 with the clamping base is mounted in the medication mixing cup, the annular protrusion of the needle plate 5-1 presses against the rubber plug strongly, so as to realize better sealing.
It can be understood that the infusion passage 11 as shown in
The medication mixer further includes an elastic clamping base 4, preferable, an independent elastic clamping base 4 as shown in
The bottom plate 4-5 is provided with a central hole 4-3, and the lower needle 5-3 penetrates through the central hole 4-3, thereby positioning the cross needle. A circle of annular protrusion 4-2 is arranged around the central hole 4-3; the region defined by the annular protrusion 4-2 is completely superimposed with the central hole 4-3, and is axially arranged with the medication mixing passage 7; the bottom plate 4-5 clings to the cup bottom 3-2 by the annular protrusion 4-2. After the elastic clamping base 4 is mounted in the medication mixing cup 3, the annular protrusion 4-2 on the elastic clamping base 4 presses against the rubber plug 6.
The needle plate 5-1 of the cross needle 5 as shown in
As for the combination of the cross needle 5, the elastic clamping base 4 as well as the medication mixing cup 3 and the base 2, as shown in
The cup wall is provided with the limit structure (not shown), the cross needle 5 with the clamping base is mounted in the medication mixing cup 3 and is limited by the limit structure. In particular, after the lower needle 5-3 pierces the rubber plug 6 and the membrane 8, the cross needle is completely limited by the limit structure.
In the embodiment, the elastic clamping base 4 is placed in the medication mixing cup 3, and then is limited by the limit structure (not shown) on the inner wall of the cup wall 3-1, thereby preventing the elastic clamping base 4 from sliding out of the medication mixing cup 3 after put in place. In addition, the position of limiting the elastic clamping base 4 makes the bottom of the elastic clamping base 4 contact with the cup bottom 3-2 of the medication mixing cup 3. In the preferable arrangement solution of the rubber plug 6, the annular protrusion 4-2 at the bottom of the elastic clamping base 4 presses against the rubber plug 6.
The needle plate 5-1 of the cross needle 5 mounted in the elastic clamping base 4 is located between the elastic clamping jaw 4-1 and the bottom plate 4-5, and afterwards, the lower needle 5-3 does not pierce the rubber plug 6.
Of course, it can be understood that before use, the lower needle 5-3 partially pierces the rubber plug 6, or as shown in
Of course, before the medication mixer is assembled and used, the cross needle 5 is just placed in the medication mixing cup 3, and does not pierce the membrane 8. The rubber plug 6 can be not pierced, or partially pierced, or completely pierced as long as the membrane 8 is not pierced, and the use of the medication mixer is not affected. When the sealing membrane 13 is tom, a partition plate 12 is taken off and the penicillin bottle 9 is inserted, as shown in
As for the use state, as shown in
Simultaneously, the bottle cap of the penicillin bottle 9 is pierced by the upper needle 5-2, and the bottle cap presses the needle plate 5-1 downwards, thereby pushing the lower needle 5-3 to pierce the rubber plug 6 and then the membrane 8, such that the medication mixing passage 7 is communicated with the penicillin bottle 9 via the cross needle 5.
Obviously, the clamping ring 4-6 of the elastic clamping base 4 has an inner diameter substantially the same as or slightly greater than the outer diameter of the penicillin bottle 9. In order to better fix and limit the penicillin bottle 9 so that the penicillin bottle 9 is not slidable, the cap thickness of the penicillin bottle 9 shall be substantially the same as the distance of the free ends of the elastic clamping jaw 4 to the bottom plate 4-5, such that the penicillin bottle 9 is just clamped between the free ends of the elastic clamping jaw 4 and the bottom plate 4-5 through the bottle cap, and cannot move up and down.
Of course, it can be understood that for the sake of a machining tolerance, the distance of the free end of the elastic clamping jaw 4-1 to the bottle plate 4-5 is slightly greater than the thickness of the bottle cap, which does not influence the butt joint and fixation of the penicillin bottle 9.
After the cross needle 5, the elastic clamping base 4 and the medication mixing cup 3 are assembled, as shown in
The elastic clamping base 4 as shown in
As shown in
The medication mixer is connected with the soft intravenous bag 1 in a welding way, to form the soft intravenous bag 1 with the medication mixer, as shown in
It can be understood that the infusion passage 11 can be arranged on the base parallel with the medication mixer, as shown in
Finally, in order to ensure the safety and sterility of the soft intraveous bag 1 in use, the medication mixing cup 3 needs to be sealed. The easy-to-tear film is usually used to seal the medication mixing cup 3, preferably, a pp easy-to-tear film, and more preferably, a breathable pp easy-to-tear film. The easy-to-tear film is directly pressed at the cup opening of the medication mixing cup 3, and is directly torn when the medication mixing cup 3 is used.
Since the soft intravenous bag 1 is sealed and then sterilized at a high temperature after filled, if the medication mixing cup 3 is not sealed, the sterilized soft intravenous bag 1 with the medication mixer is inevitably polluted during transportation and use and its sterility cannot be guaranteed due to the cross needle 5 for piercing in the medication mixing cup 3 still exposing in the external environment.
As for the sealed medication mixing cup 3, in sterilization, due to the high temperature and the high pressure, the cup body of the medication mixing cup 3 made of the medical polymer material and the easy-to-tear film of the sealed medication mixing cup 3 will soften and shrink; there is a relatively large pressure difference between the inside and outside of the sealed medication mixing cup 3; under the high pressure, the medication mixing cup 3 and the easy-to-tear film will be deformed, and be crushed after cooled, thereby damaging the structure of the medication mixing cup, and causing the medication mixer not to be used.
In order to solve the above-mentioned problem, more preferably, the reinforcing ribs 3-3 are arranged on the cup wall 3-1 of the medication mixing cup 3, preferably, at the lower half portion of the cup wall 3-1, as shown in
The reinforcing ribs 3-3 may be protruding vertical bars or horizontal bars which are integrated with the medication mixing cup 3 and uniformly arranged at the inner side and/or outer side of the cup wall 3-1, or may have a criss-crossed net structure. Preferably, the vertical bars are uniformly arranged at the lower half portion of the inner side of the cup wall 3-1; more preferably, the protruding vertical bars extend to the cup bottom 3-2 from the lower half portion of the inner side of the cup wall 3-1, and most preferably, the thickness of the vertical protrusion continuously increases gradually and smoothly from top to bottom.
The arrangement of the reinforcing ribs 3-3 on the cup wall 3-1 may substantially solve the problem that the medication mixing cup 3 is pressed and deformed during the sterilization. However, there still exists the problem that the sealing membrane 13 of the sealed medication mixing cup 3 is compressed and deformed when sterilized.
In order to solve this problem, the cover plate 12 as shown in
As for the arrangement of the cover plate 12, preferably, the cover plate 12 is arranged coaxially with the cross needle 5, and the needle point 5-5 of the upper needle 5-2 is dead against the center of the cover plate 12.
The cover plate 12 is preferably designed into a polygon with a hole in the center. The experiment shows that after the pressure balancing means is adopted, such a preferable design can balance the pressure inside and outside the medication mixing cup 3 more rapidly, thereby functioning very well in the moist heat sterilization process—the sealing membrane 13 is smooth as before, and the medication mixing cup 3 is not deformed. This is because the polygonal cover plate 12 with a central hole can increase the gas exchanging speed below and above the cover plate 12, and balance the air pressure in the medication mixing cup 3 more rapidly, as well as the air pressure outside and inside the medication mixing cup 3.
With the above-mentioned arrangement, the medication preparation and addition can be performed safely, conveniently and rapidly, which completely solves the problem of secondary pollution at the stage of the medication preparation. Simultaneously, the infusion can be traced since the penicillin bottle 9 cannot be taken out non-destructively after connected and fixed onto the medication mixing cup 3 and clamped by the elastic clamping jaw 4-1. That is, from the medication preparation to the completion of infusion, until the recovery, the medication added and injected can be traced.
However, for the medication to be preserved specially, for example the medication to be used immediately after prepared, the above-mentioned medication mixer may have some inconveniences since the medication filled in the penicillin bottle 9 must be brought to the impatient ward, then the penicillin bottle 9 is abutted with the medication mixer, and the medication can be used after preparation in the ward.
In order to meet the requirement of using the medication immediately after prepared, on the basis of the above-mentioned structure, the easy-breaking handle 10 is additionally arranged, as shown in
The easy-breaking handle 10 is arranged at the lower end of the medication mixing passage 7. As shown in
As for the shape and structure of the base 2, in order to avoid the damage of the welding portion of the base 2 to the soft intravenous bag 1 in the processes of storing, transporting and using after the medication mixer, the infusion passage 11 or the dual hard ports with the medication mixer and the infusion passage 11 are welded on the soft bag, the base 2 is designed into a shape of a dumbbell or ship, as shown in
As for the selection of the materials of the medication mixer and the soft intravenous bag 1, the soft intravenous bag 1 is made of the widely used non-PVC officinal compounding velamen, including three or five layers.
The medication mixer is made of the medical polypropylene material having good compatibility with the non-PVC material of the soft intravenous hag 1. The base 2, the medication mixing cup 3 and the cover plate 12 are preferably made of the polypropylene R530C material; however, the cross needle 5 and the clamping body are preferably made of the P17 material in the pp material system in view of its piercing property and mechanical characteristics.
The cross needle 5, the limit protrusion and the limit structure are made of the polypropylene material, preferably, the polypropylene P17 material.
Finally, the most critical point of the medication mixer with a sealing structure is the terminal sterilization after the sealed medication mixer is welded on the soft hag. Currently, from the point of view of laws and regulations as well as practical injection safety, the terminal sterilization must be performed to all the medication packages before the filling and delivery.
At present, there are mainly two sterility assurance processes for the injection:
1. A process of terminal sterilization: on the basis of controlling a pollution load of microorganism, after the medication is filled, the degerming is realized by moist heat sterilization. Usually, this method has a low cost, a high level of sterility assurance, and is suitable for sterilizing both a large volume injection and a small volume injection.
2. A process of sterile production: under an environment of a sterile system, by sterile filtration or sterile operation, for the purpose of de-pollution, the sterility level is assured by eliminating various possibilities of causing pollutions. Generally, due to a high demand of this method on the environment system, and many factors of influencing the sterile operation, the sterility assurance level is lower than that in the terminal sterilization process. The sterile production process is usually suitable for powder-injection, and also for clinical needs, but not for the small volume injector which may be realized in the terminal sterilization. Thus, the terminal sterilization process has different system requirements, different sterilization methods and different sterilization assurance results from the sterile production process.
The large volume infusion is very sensitive to the cost. Therefore, the terminal sterilization in the large volume infusion may only adopt the moist heat sterilization process with a low cost and high efficiency, which is usually conducted at a high temperature of 115-121 degrees Celsius, under the steam with a pressure of 0.15 MPa, for 30-15 minutes.
Although the medication mixer and the soft intravenous bag 1 are made of the polypropylene material withstanding the high temperature of 120 degrees Celsius, at such a high temperature, the sealed medication mixer will degrade in mechanical characteristics, and tends to deform under the intensity of pressure of 0.15 MPa; however, the sealing membrane 13 will also be deformed and wrinkled at this temperature and intensity of pressure, losing the sealing effect.
From the year 2011 to 2014, hundreds of experiments were conducted, and the solution is determined from different aspects.
First, as for the structure of the medication mixing cup 3, as shown in
The reinforcing ribs 3-3 may be protruding vertical bars or horizontal bars which are integrated with the medication mixing cup 3 and uniformly arranged at the inner side and/or outer side of the cup wall 3-1, or may have a criss-crossed net structure. Preferably, the vertical bars are uniformly arranged at the lower half portion of the inner side of the cup wall 3-1; more preferably, the protruding vertical bars extend to the cup bottom 3-2 from the lower half portion of the inner side of the cup wall 3-1, and most preferably, the thickness of the vertical protrusion continuously increases gradually and smoothly from top to bottom.
The medication mixing cup 3 with the reinforcing ribs 3-3 improves the mechanical pressure resistance of the cup body to a considerable extent. With the experimental comparison, the medication mixing cup 3 without the reinforcing ribs 3-3 is compressed into a square from the initial circular shape after the moist heat sterilization is performed, and cannot be used any more.
After the reinforcing ribs 3-3 are arranged, subsequent to the moist heat sterilization process, the circular medication mixing cup body is slightly compressed, and can be continue to use normally.
Moreover, the sealing membrane 13 is only a very thin easy-to-tear film, for sealing the medication mixing cup 3 and being convenient to tear out in use. The sealing membrane 13 is thinner than the cup body of the medication mixing cup 3 since the sealing membrane 13 itself is only a layer of thin film with a thickness of micron dimension, and cannot withstand the intensity of pressure of 0.15 MPa in the moist heat sterilization process.
As for this, numerous experiments show that the cover plate 12 as shown
The cover plate 12 has a circular shape substantially matched with the shape of the cup opening of the medication mixing cup 3. Preferably, the cover plate 12 has a shape in cross section of polygon, for example, pentagon, hexagon, octagon and dodecagon. The polygonal cover plate 12 is conveniently taken out in use; its another unexpected effect will be mentioned in the following.
In addition, in order to enhance the compressive strength of the cover plate 12, preferably, the cover plate 12 is arranged coaxially with the cross needle 5, with the needle point 5-5 of the upper needle 5-2 dead against the center of the cover plate 12, for supporting the cover plate 12. More preferably, one through hole 12-1 is arranged in the center of the cover plate 12 which has an inner diameter less than an outer diameter of the upper needle 5-2. The needle point 5-5 of the upper needle 5-2 is partially located in the through hole 12-1, but cannot penetrate therethrough. That is, the needle point 5-5 of the upper needle 5-2 is embedded in the through hole 12-1 of the cover plate 12, thereby better supporting the cover plate 12 by the upper needle 5-2.
Simultaneously, in view of an intense downward pressure born by the cover plate 12, the cover plate 12 is reinforced other than the design of supporting the cover plate 12 by the upper needle 5-2. The radial and annular reinforce ribs 12-2 as shown in
The sealing membrane 13 press welded on the upper end of the cup opening is tightly stuck on the upper surface of the cover plate 12, such that the sealing membrane 13 does not need to withstand a high pressure, which greatly buffer the deformation and wrinkle of the sealing membrane 13.
As for the wrinkle, since the sealing membrane 13 is too thin, the wrinkle will be caused even by a slight pressure, which seriously influences the vision effect of the product.
By many contrast experiments, a layer of thin metal film is plated on the upper surface of the sealing membrane 13 may effectively alleviate the problem of wrinkle of the sealing membrane.
Although the sealed medication mixer with such an arrangement withstands the high temperature and high pressure in the moist heat sterilization process and can be used normally, the product appearance cannot be kept in a good state. In view of the infusion product, it is not qualified.
The above-mentioned design for the structure of the medication mixer can only ensure the use function. In order to completely solve the problem of terminal sterilization of the sealed medication mixer, it needs to fundamentally solve the balance of air pressure inside and outside in the moist heat sterilization of the sealed medication mixing cup.
After the medication mixing cup 3 is assembled and before the cover plate 12 and the sealing membrane 13 are mounted to seal the medication mixing cup, a certain amount of liquid is prefilled in the cup body, and then the cover plate 12 is mounted to seal the medication mixing cup.
When the terminal sterilization is performed on the sealed medication mixing cup 3 with liquid filled in and the soft intravenous bag 1, the liquid is rapidly vaporized at a high temperature, thereby balancing the pressure inside and outside the cup body rapidly.
As for the prefilled liquid, preferably, the thermal capacity is relatively small, to saturate the liquid with a relatively high steam pressure. We have studied that the states of various liquid at a temperature of 120 degrees Celsius under the pressure of 0.15 MPa, including common harmless liquid such as water and ethyl alcohol, can meet our requirements. In view of costs and safety, preferably, the prefilled liquid is water.
The important prefilled water amount V0 can be confirmed through the following equation:
PV=nRT, wherein P is an inside-outside pressure difference in the moist heat sterilization, V is a volume of the medication mixing cup 3, n is a mole number of the prefilled liquid/water, R is a gas constant, and T is an absolute temperature in the moist heat sterilization.
V0=n*M/p, wherein M is a mole mass of the liquid/water, and p is a density of the liquid/water.
According to the above-mentioned equation, the pressure inside and outside in the terminal sterilization of the sealed medication mixer can be well balanced.
It is a preferable solution that the pressure inside and outside is balanced in a manner of prefilled liquid.
However, the above-mentioned solution may solve the problem of pressure balance. In practical use, there still exist some problems. The most typical problem is that the finished soft intravenous bag subjected to sterilization, after being cooled, has water drops or liquid in the medication mixing cup, which affects the impression. Moreover, such a product is not accepted by hospitals or patients.
On this basis, one more preferably solution is that we have specially studied the breathable sealing membrane 13 based on the pp material system, which ensures sufficient gas exchange of the breathable sealing membrane 13 with outside after the vaporization of liquid, so there is no residual liquid in the medication mixing cup 3 after the sterilization.
Through many experiments for a long time, the air permeability of the breathable sealing membrane 13 is, most preferably, 5%-35%.
As for the medication mixer sealed by our breathable sealing membrane 13, subsequent to the moist heat high temperature sterilization, the medication mixing cup 3 is not deformed, and the sealing membrane 13 is smooth as before, without any wrinkle.
Of course, there is one improved solution that the breathable sealing membrane 13 with a suitable air permeability is directly adopted to seal the medication mixer, without pre-filling liquid, which is also feasible, proved by many experiments.
After the assembled medication mixer, that is the cross needle 5 with the clamping base, is placed in the medication mixing cup 3, the cup opening of the medication mixing cup 3 is sealed usually by the sealing membrane 13 or the easy-to-tear sealing membrane in a press welding way; or one cover plate 12 is placed at the cup opening, and then the sealing membrane 13 is placed thereon. The sealed medication mixing cup 3 is welded on the soft intravenous bag 1, so as to form the soft intravenous bag 1 with the medication mixer, as shown in
On the basis of the above-mentioned first embodiment, as for the arrangement of the elastic clamping base 4 in the first embodiment, in the second embodiment as shown in
After the cross needle 5 as shown in
Obviously, the distance of the upper surface of the cup bottom 3-2 to the lower surface of the membrane 8 is less than the length of the lower needle 5-3.
Other structures of the medication mixer are the same as those in the first embodiment.
On the basis of the above-mentioned first embodiment, as for the arrangement of the elastic clamping base 4 in the first embodiment, in the third embodiment as shown in
Like the elastic clamping base 4 in the first embodiment, the elastic clamping base 4 in the third embodiment includes one clamping ring 4-6 provided with an elastic clamping jaw 4-1 at the lower side. The upper ends of the elastic clamping jaw 4-1 are arranged uniformly and fixed along the clamping ring 4-6, and the lower ends of the elastic clamping jaw 4-1 are free ends. The elastic clamping jaw 4-1 inclines towards the center of the medication mixing cup 3 from the fixed upper ends to the free ends. The elastic clamping base 4 has a bottom plate 4-5, a supporting column 4-4, a clamping ring 4-6 and an elastic clamping jaw 4-1 which are integrally formed. The supporting column 4-4 is arranged at the periphery of the bottom plate 4-5, for supporting and fixing the clamping ring 4-6.
The difference between the first embodiment and the third embodiment is that the central hole 4-3 on the bottom plate 4-5 is omitted, and the cross needle 5 is integrally fixed on the bottom plate 4-5 directly. The structures of the upper needle 5-2 and the lower needle 5-3 are the same as those as shown in
A circle of annular protrusion 4-2 is arranged at the root of the lower needle 5-3. After the elastic clamping base 4 is mounted in the medication mixing cup 3, the annular protrusion 4-2 on the elastic clamping base 4 presses against the rubber plug 6.
Before use, the elastic clamping base 4 is mounted in the medication mixing cup 3 and is limited by the cup wall 3-1 and cannot be taken out when pushed to the cup bottom 3-2. As shown in
Of course, or, as shown in
The upper ends of the elastic clamping jaw 4-1 are arranged evenly and fixed along the clamping ring. The lower ends of the elastic clamping jaw are free ends, and the elastic clamping jaw 4-1 inclines towards the center of the medication mixing cup from the fixed upper ends to the free lower ends. There is a plurality of elastic clamping jaws 4-1, preferably, three or four.
The limit protrusion is arranged on an inner wall of the cup wall. After the cross needle is mounted in the medication mixing cup, the needle plate is limited between the limit protrusion and the cup bottom by the limit protrusion, and cannot be taken out. The limit protrusion herein is preferably an elastic clamping jaw.
The cross needle 5 with a clamping base is placed in the medication mixing cup 3. As shown in
Other structures of the medication mixer are the same as those in the first embodiment.
It shall be understood that the above embodiments of the present invention are only used for illustratively explaining the principle of the present invention, without limiting the present invention. Therefore, all the medications, equivalent substitutions and improvements made without departing from the spirit and scope of the present invention shall fall within the protection scope of the present invention. In addition, the claims of the present invention are directed to covering all variations and modifications falling within the scope and boundary of the claims, or the equivalent scope and boundary.
Number | Date | Country | Kind |
---|---|---|---|
201510780465.8 | Nov 2015 | CN | national |
201510781506.5 | Nov 2015 | CN | national |
201510781507.X | Nov 2015 | CN | national |
Filing Document | Filing Date | Country | Kind |
---|---|---|---|
PCT/CN2016/105564 | 11/13/2016 | WO | 00 |