WO2008124979A1

WO2008124979A1 - Transdermal medication apparatus

Info

Publication number: WO2008124979A1
Application number: PCT/CN2007/003218
Authority: WO
Inventors: Gang Chen
Original assignee: Beijing Sinohanfang Pharmaceutical Sci.& Tech. Co., Ltd.
Priority date: 2007-04-11
Filing date: 2007-11-14
Publication date: 2008-10-23
Also published as: CN101284157A; CN101284157B

Abstract

A transdermal medication apparatus includes an applying disk (1) applied on the skin, a drug pad (2) provided in the lower portion of the applying disk (1). The top portion of the applying disk (1) is a top surface (3). An outer annular cavity (4) and a central cavity (5) opening downward are provided below the top surface (3). An annular sidewall is between the outer annular cavity (4) and the central cavity (5). The outer annular cavity (4) is communicated with a negative pressure source via a negative pressure source channel outlet (7). The drug pad (2) is provided in the central cavity (5). The outer annular cavity (4) is divided into an upper and a lower concaves by an air permeable clapboard (8), the upper concave is communicated with the negative pressure source via the negative pressure source channel open (7), and the lower concave opens downward.

Description

Transdermal drug delivery device. Technical field

The present invention relates to a medical device, and more particularly to a transdermal drug delivery device. Background technique

The percutaneous delivery device only has the function of fixing, covering the drug and promoting drug penetration. The Chinese invention patent CN2159790Y announced on March 20, 1994 discloses a "medical pull-up canister". A concentric cylindrical tank is added to the conventional cylindrical cupping. In use, the annular cavity between the two cylinders forms a negative pressure in a common manner, adsorbing the skin of the treatment site, and positioning the drug embedded in the middle cavity surrounded by the inner cylinder, and at the same time, the drug is under negative pressure in the surrounding annular cavity. Attracting, increased the power of penetration. The annular cavity raises the skin under the action of negative pressure, and the capillary of the skin is broken when the time is long. The skin is congested, ruptured, and even blistered. Traditional cupping therapy is used to achieve therapeutic effects on the skin. Therefore, the treatment time of the traditional cupping therapy is generally controlled within 8-10 minutes, and at least one more interval between the two treatment times, and continuous treatment is not possible every day. Therefore, the above-mentioned cupping type adsorption method can generate a large negative pressure and is tightly sealed, but is liable to cause damage to the skin, and is not suitable for a transdermal administration method which requires long-term use on the skin. The "transdermal drug delivery device" disclosed in the Chinese invention patent CN1130237C published on February 14, 2003 is formed by consolidating the top surface with two annular side walls of the inner ring and the outer ring. The annular cavity multiplied between the inner and outer rings and the top surface communicates with the negative pressure source through the passage port. In use, the annular cavity absorbs and raises the skin under the action of negative pressure. Because the height of the annular side wall is low, the skin will rise to a certain extent and will contact the top surface. When the negative pressure continues to rise, the skin will not Continue to raise, thereby preventing skin damage. However, the raised skin also blocks the passage opening, so that the negative pressure on the skin is not high, that is, the negative pressure on the skin is lower than the pressure from the negative pressure source. The annular cavity raises the skin under the action of the negative pressure, so that the medicine in the central cavity formed by the inner ring and the top surface is closed, the temperature of the central cavity is increased under the heating of the electric heating element, the pressure is increased, and the drug is in the central cavity. The push of pressure and the suction of the surrounding annular cavity can accelerate the transdermal penetration into the skin for therapeutic effects. When the central chamber produces positive pressure. The top surface of the cavity is subjected to an outward thrust, and the annular cavity is subjected to a suction force applied to the skin under the action of the negative pressure. The sealing of the annular cavity is achieved by the pressing force applied to the annular side walls of the inner ring and the outer ring by the top surface. The greater the pressing force, the stricter the sealing. But due to the positive pressure generated by the central cavity The upper thrust cancels out part of the suction force generated by the annular cavity, so that the pressing force on the skin on the annular side wall is reduced, and when the actual negative pressure of the annular cavity is small, the sealing property of the application disk is lowered, which is easy. This causes the application tray to fall off and affects the normal operation of the operation. Summary of the invention

SUMMARY OF THE INVENTION The object of the present invention is to provide a transdermal drug delivery device which, when combined with a drug treatment, increases the transdermal administration power, not only forms a tight seal on the skin surface, but also effectively avoids long-term negative effects. The damage caused by pressure adsorption on the skin, the outer ring cavity is divided into two upper and lower cavities by a gas permeable partition; the technical problem of damage to the skin caused by the long-term negative pressure adsorption of the existing transdermal drug delivery device is solved;

There is also provided a transdermal drug delivery device having a suffix channel opening inwardly from the atmospheric environment via a one-way valve on the top surface above the central cavity; and providing a positive communication with the positive pressure source The percutaneous drug delivery device of the pressure channel port; solves the problem that the existing central cavity can not maintain a certain positive pressure during the treatment process, and the technique of poor percutaneous administration is insufficient;

There is also provided a transdermal drug delivery device having a sub-chamber communicating with the central cavity and the top surface; the technical solution for adsorbing the drug solution in the existing pad to the channel port and the pressure source is solved. .

The technical solution adopted to achieve the object of the present invention is:

A transdermal drug delivery device comprising an applicator plate attached to the skin, and a pad provided on a lower portion of the applicator plate, the upper part of the applicator plate being a top surface, and the opening below the top surface is provided with an opening downward The annular cavity and the central cavity are an annular side wall between the outer ring cavity and the central cavity, and the outer ring cavity communicates with the negative pressure source through the negative pressure passage port in the top surface, and the medicine pad is placed in the central cavity, and the feature is: The outer ring chamber is divided into two upper and lower cavities by a gas permeable partition, wherein the upper chamber communicates with the negative pressure source through the negative pressure passage port, and the lower chamber opens downward.

The gas permeable partition is made of a gas permeable material and has a ring shape, and the gas permeable partition is sealed between the annular side walls on both sides of the outer ring cavity.

An annular groove is formed in the annular side wall at an end of the annular side wall on both sides of the outer ring cavity, and an annular groove is provided on both inner end sides of the annular side wall; the venting spacer is made of a gas permeable material The utility model has an annular shape and a longitudinal section with an arched shape; a concave annular belt is arranged at two opposite ends of the gas permeable partition, the outer end of the two concave annular belt is embedded in the annular groove, and the lowermost end of the gas permeable partition is embedded in the annular groove Inside the mouth, and below the outer end of the annular side wall.

The gas permeable partition is composed of a sieve plate having a plurality of through holes and a gas permeable material; the sieve plate is fixed on the annular side walls on both sides of the outer ring cavity, and the gas permeable material is attached Placed on the sieve plate On the surface.

The gas permeable material is at least one of cloth, gas permeable rubber, and gas permeable ceramic.

An electric heating element is disposed in the top surface, and is connected to the power line through a connector on the top surface. An air inlet passage is provided on the upper surface of the central cavity, and the air supply passage communicates with the atmospheric environment through a one-way valve, and the gas flows in a direction from the atmospheric environment to the central cavity.

A positive pressure passage opening communicating with the positive pressure source is disposed on the upper surface of the central cavity. A secondary chamber communicating therewith is further disposed between the central chamber and the top surface, and the secondary chamber is in communication with the variable pressure source via a variable pressure passage port.

The partition between the sub-chamber and the central chamber is provided with a plurality of through holes communicating between the two, and the through holes are evenly distributed on the inner side of the partition and the inner side of the outer edge. DRAWINGS

Figure 1 is a cross-sectional view showing the embodiment of the present invention in use;

Figure 2 is a bottom plan view of an embodiment of the present invention;

Figure 3 is a partial cross-sectional view showing Embodiment 1 of the present invention;

Figure 4 is a partial cross-sectional view showing a second embodiment of the present invention;

Figure 5 is a partial cross-sectional view showing a third embodiment of the present invention;

Figure 6 is a cross-sectional view showing a fourth embodiment of the present invention;

Figure 7 is a cross-sectional view showing a fifth embodiment of the present invention;

Figure 8 is a cross-sectional view showing a sixth embodiment of the present invention;

Figure 9 is a bottom plan view showing a sixth embodiment of the present invention. detailed description

The present invention will be further described in detail below with reference to the accompanying drawings and embodiments.

As shown in Fig. 1 and Fig. 2, Fig. 1 is a structural view showing a state of use according to an embodiment of the present invention. The present invention includes an applicator pad 1 attached to the skin, and a pad 2 disposed on the lower portion of the applicator pad 1. The upper part of the applicator disk 1 is a top surface 3, and below the top surface 3 is provided an outer ring cavity 4 with an opening downward and a central cavity 5, and an annular side wall 6 is formed between the outer ring cavity 4 and the central cavity 5. The outer ring chamber 4 is divided into two upper cavities by a gas permeable partition 8, wherein the upper chamber communicates with the negative pressure source via the negative pressure passage port 7, and the lower chamber opens downward. Lower cavity It can accommodate skin that has been lifted by vacuum suction during use. The outer ring chamber 4 communicates with the source of negative pressure through the negative pressure passage port 7 in the top surface 3, and the pad 2 is placed in the central chamber 5.

In the embodiment 1 shown in FIG. 3, the gas permeable partition 8 is formed of a gas permeable material 14 in a ring shape, and the gas permeable partition 8 is sealed between the annular side walls 6 on both sides of the outer ring chamber 4, and The top surface 3 is parallel.

In the embodiment 2 shown in Fig. 4, annular grooves 9 are provided in the annular side walls 6 at the ends of the annular side walls 6 on both sides of the outer ring chamber 4. Annular notches 10 are provided on both inner ends of the annular side wall 6. The ventilating partition plate is made of a gas permeable material, has a ring shape, and has a longitudinal cross section in an arch shape. A concave endless belt 11 is provided at both side ends of the gas permeable partition 8, and the outer end of the concave endless belt 11 is embedded in the annular groove 9, i.e., the two are plugged. The lowermost end of the gas permeable partition 8 is embedded in the annular groove 10 and lower than the outer end of the annular side wall 6. After installation, the concave annulus 11 is raised under the negative pressure under the action of the negative pressure in the therapeutic use, and is in contact with the gas permeable partition 8 which is in close contact with the skin, and the adjacent annular side wall 6 ends. The part can function as a seal.

In the embodiment 3 shown in Fig. 5, the gas permeable partition 8 is composed of a sieve plate 13 having a plurality of through holes and a gas permeable material 14. The sieve plate 13 is fixed on the annular side walls 6 on both sides of the outer ring cavity 4, and the gas permeable material 14 is placed on the lower surface of the sieve plate 13, that is, facing the skin surface during treatment. The material of the sieve plate 13 may be the same material as the main body of the application tray 1, or may be a different material. If the sieve 13 is made of ceramic, the outer ring cavity 4 can be molded by a lost wax type imitation method; if the sieve plate 13 is made of a rubber material, the secondary vulcanization method can be used to mold the semi-finished product of the first process. After positioning with the main body of the application tray, the second process is vulcanized to obtain the final product. The small holes in the sieve plate 13 can be directly produced during the molding process. It can also be machined by drilling after the finished product is made.

In Embodiments 1 to 3, the manner in which the gas permeable partition 8 and the annular side wall 6 are fixed is provided. The gas permeable material _{14 is} at least one of cloth, gas permeable rubber and gas permeable ceramic. Embodiment 1, for a rigid gas permeable ceramic, a tight fit consolidation method may be employed. In this way, the application tray 1 is placed on the human skin, and the negative pressure passage port 7 on the top surface 3 of the outer ring chamber 4 communicates with the negative pressure source, and the pressure in the outer ring chamber 4 is lowered, and the corresponding skin is gradually Lift up until it fills the entire outer ring cavity 4. In this way, the combination is tight and there is no gap, which eliminates the risk of the skin being caught in the gap and causing injury. A soft cloth or a breathable rubber is bonded and consolidated.

In the embodiment 4 shown in Fig. 6, an electric heating element 15 is provided in the top surface 3, and is connected to the power supply line through the connector 12 on the upper portion of the top surface 3. During the treatment, with the heating element 15 facing the center The cavity 5 is warmed, the temperature of the gas in the cavity of the central cavity 5 is increased, the volatile component of the drug is gradually released, and the pressure in the cavity is increased. At the same time, the skin temperature of the treatment site will also increase, which can speed up the movement of blood in the subcutaneous capillaries, increase the permeability of the skin, and promote the penetration of the drug. The top surface 3 of the central cavity 5 of the applicator disk 1 may be in the same plane as the top surface 3 of the outer ring cavity 4, similar to that shown in Fig. 1, the pad is thermally convected by radiation and radiation. Exchange, absorb heat. Alternatively, as shown in FIG. 5, the top surface 3 of the central cavity 5 is set lower, the height of the central cavity 5 is equivalent to the height of the pad 2, and the heat of the top surface 3 can directly heat the pad by contact conduction, during heating. Such a heat transfer method is more direct and effective when the component power is not large and the surface temperature of the surface is not high.

In the embodiment 5 shown in FIG. 7, a gas supply passage opening is provided on the upper surface of the central cavity 5, and the air supply passage opening communicates with the atmospheric environment through a one-way valve, and the gas flow direction is Flow from the atmospheric environment to the central cavity 5. In this way, the outer ring cavity 4 can prevent the gas in the central cavity 5 from leaking into the adjacent outer ring cavity 4 when the annular side wall 6 and the skin are not tightly sealed when the suction is connected to the negative pressure source. As a result, the initial pressure of the central chamber 5 is low, even a negative pressure, so that the central chamber 5 is naturally raised in temperature, and the final elevated pressure is low. The use of this one-way valve relatively enhances the power of the transdermal drug and promotes the penetration of the drug. A positive pressure passage opening 16 communicating with the positive pressure source is disposed on the face above the central chamber 5. This allows the central lumen 5 to maintain the required positive pressure and enhance the effect of transdermal administration.

In the embodiment 6 shown in FIG. 8, on the basis of the embodiment 5, a sub-chamber 17 is also provided between the central cavity 5 and the top surface 3, and the sub-chamber 17 passes through a sub-chamber 17 The variable pressure port port is in communication with a variable pressure source. At the beginning of the treatment, the negative pressure source is turned on first, and both the sub chamber 17 and the central chamber 5 are under negative pressure, and the skin under the central chamber 5 is attracted by the negative pressure to increase the permeability. Turning on the positive pressure source again, both the secondary chamber 17 and the central chamber 5 become positive pressure, allowing the drug to penetrate better into the skin. The sub-chamber 17 is provided, and when the negative pressure stage of the pressure source is turned on, since the variable pressure passage port 18 is spaced apart from the pad 2 of the central chamber 5 by the sub-chamber 17, the medicine placed in the central chamber 5 can be avoided. The liquid chemical in the pad 2 is adsorbed into the variable pressure passage port 18 and the pressure source, causing contamination of the variable pressure passage port 18 and failure of the pressure source, and also avoiding the loss of the chemical liquid. A plurality of through holes 19 communicating the two are provided in the partition between the subchamber 17 and the central chamber 5, and the through holes 19 are evenly distributed inside the center of the partition and the inner side of the outer rim. When the sub-chamber 17 is connected to the negative pressure source, the chemical liquid is sucked from the central chamber 5 into the sub-chamber 17; when the sub-chamber 17 is connected to the positive pressure source, the chemical liquid is returned to the central chamber through the through-hole 19 5. In summary, Examples 1 to 3 are illustrative of several different configurations of the gas permeable separator 8 of the present invention. Further, Examples 4 to 6 are structural optimizations performed on the basis of Examples 1 to 3, and one or a combination of them may be selected. It can be combined with the three venting partitions 8 shown. In addition, the structure of the gas permeable partition 8 is not limited to the above three structures. The cross section of the invention may be of the racetrack type as shown in Fig. 2, or may be circular as shown in Fig. 9, or may be of a profiled type. Industrial applicability

The invention can increase the transdermal administration power when combined with drug treatment, and can form a strict seal on the surface of the human skin; in the case of transdermal drug delivery, the negative pressure channel port of the outer ring cavity is connected with the negative pressure source. The pressure drops, and the corresponding skin will gradually stretch and rise. Since a gas permeable partition is added to the outer ring cavity, the skin will not continue to rise after contacting the lower surface of the gas permeable partition, thereby protecting the skin from excessive pulling. Stretching damage, ensuring that percutaneous administration can be performed normally for a long time; at this time, the pressure in the outer ring cavity can continue to decrease until it is equal to the pressure of the negative pressure source; because the negative pressure of the outer ring cavity is large, in the same outer ring Under the cavity area, the adsorption force acting on the application plate is large, and the adsorption on the skin is firm, which can effectively offset the outward thrust generated by the positive pressure of the central cavity and prevent the treatment interruption caused by the application plate falling off; The pressing force acting on the annular side wall is increased, the sealing property is improved, the leakage of the central cavity is reduced, and the central cavity is more effectively maintained to maintain a high positive pressure, plus Increase in the negative pressure chamber, it may be such that the power increase percutaneous administration, the effect of improving transdermal administration; drug solution in the central chamber of pad is not adsorbed into the channel port and the pressure source.

Claims

Rights request

A transdermal administration device comprising an application tray (1) attached to the skin, and a pad (2) disposed at a lower portion of the application tray (1), the upper portion of the application tray (1) being The top surface (3) is provided with an open outer ring cavity (4) and a central cavity (5) below the top surface (3), and an annular side between the outer ring cavity (4) and the central cavity (5) The wall (6), the outer ring cavity (4) communicates with the negative pressure source through the negative pressure passage port (7) in the top surface (3), and the medicine pad (2) is placed in the central cavity (5), which is characterized by: The outer ring chamber (4) is divided into upper and lower cavities by a gas permeable partition (8), wherein the upper chamber communicates with the negative pressure source via the negative pressure passage port (7), and the lower chamber opens downward. .

2. A transdermal delivery device according to claim 1 wherein: said permeable barrier

(8) The gas permeable material (14) is annular, and the gas permeable partition (8) is sealed between the annular side walls (6) on both sides of the outer ring chamber (4).

3. A transdermal delivery device according to claim 1 wherein: said outer ring cavity

(4) The end of the annular side wall (6) on both sides is provided with an annular groove (9) in the annular side wall (6), and an annular groove is provided on the inner side ends of the annular side wall (6) (10) The gas permeable partition (8) is made of a gas permeable material, has a ring shape, and has a longitudinal cross section; a concave ring band (11) is provided at both ends of the gas permeable partition (8), and the two concave ring bands are provided. The outer end is embedded in the annular groove (9), and the lowermost end of the gas permeable partition (8) is embedded in the annular groove (10) and lower than the outer end of the annular side wall (6).

4. A transdermal delivery device according to claim 1, wherein: said gas permeable partition (8) is formed by a composite of a sieve plate (13) having a plurality of through holes and a gas permeable material (14). The sieve plate is fixed on the annular side wall (6) on both sides of the outer ring cavity (4), and the gas permeable material (14) is placed on the lower surface of the sieve plate (13) .

A transdermal drug delivery device according to claim 2 or 3 or 4, wherein the gas permeable material (14) is at least one of a cloth, a breathable rubber, and a gas permeable ceramic.

6. A transdermal delivery device according to claim 1, characterized in that an electric heating element (15) is arranged in said top surface (3) through a connector on the top of the top surface (3) ( 12) Connect to the power cord.

7. A transdermal delivery device according to claim 1 wherein: said central cavity

(5) An air inlet passage is provided on the upper surface, and the air inlet passage communicates with the atmosphere through a one-way valve, and the gas flows in a direction from the atmospheric environment to the central chamber (5).

The transdermal drug delivery device according to claim 7, characterized in that: a positive pressure channel opening communicating with the positive pressure source is provided on the upper surface of the central cavity (5) (16) ).

9. A transdermal delivery device according to claim 1 or 6, wherein a secondary chamber communicating therewith is further disposed between said central chamber (5) and said top surface (3) (17) The secondary chamber (17) is in communication with a variable pressure source via a variable pressure port (18).

10. A transdermal delivery device according to claim 9, wherein: a plurality of through holes are provided in the partition between the subchamber (17) and the central chamber (5). (19) The through holes (19) are evenly distributed on the inner side of the partition and on the inner side of the outer edge.