Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
  • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
  • A61M5/142—Pressure infusion, e.g. using pumps
  • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
  • A61M5/14586—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm
  • A61M5/14593—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of a flexible diaphragm the diaphragm being actuated by fluid pressure
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
  • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
  • A61M2037/0023—Drug applicators using microneedles

Definitions

• Transdermal therapeutic system with pressure generating device Transdermal therapeutic system with pressure generating device
• the invention relates to a transdermal therapeutic system with a
• Feed element comprises a means of liquid absorption expandable source body.
• the present invention is based on the problem to reinforce the effect of the feed element.
• the system carrier is at least partially formed resistant to deformation.
• FIG. 1 Transdermal therapeutic system
• Figure 2 system after putting on the skin
• FIG. 3 system during the delivery of the active substance into the skin
• Figure 4 system with hollow needles on the feed element
• FIG. 5 system with bending and torsion-resistant pressure plate
• FIG. 6 System with the active substance reservoir penetrating
• FIG. 7 System as Figure 6 with hollow needles
• FIG. 8 system with integrated water reservoir
• FIG. 9 System of Figure 8 after opening the
• FIGs 1-3 show a transdermal therapeutic system (10).
• Such systems (10) are used to introduce liquid or liquefiable active ingredients into the skin (2) of a patient. It has one of the skin (2) of the patient zuwendbare application side (11) and a side facing away from this handling side (12).
• the transdermal therapeutic system (10) comprises a system carrier (21) which is fortified, for example, by means of an adhesive layer (22) on the skin (2) of the patient.
• This adhesive layer (22) may be free of active ingredients. It can on the skin (2) facing support surface (24) on a support member (23) of the
• the skin (2) facing away from the system carrier (21) carries in
• the system carrier (21) is constructed as a concave body. He includes one
• the wall parts (27) are twice as thick as the ceiling part (26).
• the thickness of the cover part (26) is more than one third of the height of the transdermal therapeutic system (10) above the support surface (24).
• the system carrier (21) thus has a high moment of resistance against buckling of the ceiling part (26). in the embodiment, an additional on the inside of the ceiling part (26)
• Protective layer (82) arranged.
• the height of the wall parts (27) in a direction normal to Support surface (24) is greater than two-thirds of the total height of the transdermal therapeutic system (10) above the support surface (24). This has the
• System carrier (21) a high moment of resistance against both bending and torsion.
• the system carrier (21) is thus formed resistant to deformation, under
• the wall parts (27) and the ceiling part (26) form a shell (25) and define on five sides an inner space (28) of the system carrier (21).
• the connection of the wall parts (27) and the ceiling part (26) form a shell (25) and define on five sides an inner space (28) of the system carrier (21).
• Wall parts (27) on the ceiling part (26) may be rectangular. In the region of this connection grooves can be formed. However, the interior space (28) can also be opened in a funnel shape in the direction of the application side (11). The angle enclosed by a wall member (27) and a vertical plane is e.g. less than or equal to 45 degrees.
• a feed element (31) is arranged in the interior (28) in the interior (28) in the interior (28) is a feed element (31) is arranged. This is in the interior (28) in the interior (28) is a feed element (31) is arranged. This is in the interior (28) in the interior (28) is a feed element (31) is arranged. This is in the interior (28) in the interior (28) is a feed element (31) is arranged. This is in the interior (28) in the interior (28) is a feed element (31) is arranged. This is in
• the feed element (31) consists in the embodiment of an elastically and / or plastically deformable material.
• the base materials of the feed element (31) are, for example, networked
• Sodium polyacrylate or crosslinked polyacrylamides is conceivable. These materials are hydrophilic. Depending on the composition and type of liquid, they can absorb 30 to 800 times their mass of liquid. For example, the capacity is determined by the electrical potential difference of the material and the liquid to be absorbed. In the embodiment, water is used as the liquid. This can be distilled or demineralized.
• Feed element (31) For example, the increase in volume is proportional to the volume of liquid absorbed.
• the feed element (31) is therefore also referred to below as the source body (31).
• a drug reservoir (4) is embedded in the feed element (3). It stands on the support surface (24) out of this.
• the drug reservoir (41) is bag-like formed and contains one or more active ingredient preparations. It is made of an elastically deformable material.
• Active substance reservoirs (41) embedded in the feed element (31) can be arranged side by side or one above the other.
• the feed element (31) can be arranged side by side or one above the other.
• Walls (42) of the drug reservoirs (41) semipermeable or equipped such that, for example, individual drugs are mixed together immediately prior to use.
• An intermediate layer (61) can be arranged between the advancing element (31) and the active substance reservoir (41). This can for example be formed as a pressure plate (61) and / or as a water-absorbing layer (61) or the
• Active ingredient-containing layer (41) is separated from the feed element (31) by, for example, a film (for example PET).
• a needle carrier (43) with a plurality of needles (45) is further attached on the drug reservoir (41).
• the needle carrier (43) and the needles (45) protrude from the bearing surface (24) on the side facing away from the system carrier (21).
• Needle carrier (43) comprises, for example, a distribution channel (48) and connects the active substance (44) filled interior (46) of the W irkstoffreservo irs (41) with the
• the active substance reservoir (41) can also be designed without a distribution channel (48).
• the needle carrier (43) then forms a boundary of the interior (46) of the drug reservoir (41).
• the single needle (45) has a length between 10 micrometers and one millimeter. Its outer diameter is between ten microns and 500 microns. In the exemplary embodiment, all needles (45) are designed as hollow needles. Of the
• Diameter of the through hole (47) is between 3 microns and
• the needles (45) attached to the needle carrier (43) on the application side (11) can also be designed as porous needles (45) or as detachable needles (45).
• the needles (45) shown conically in the figures can also have a cylindrical shaft and a conical tip. The Needles (45) thus connect the interior (46) of the drug reservoir (41) with the environment (1).
• needles (33) on the feed element (31), cf. Figure 4. These have, for example, the same inner and outer dimensions as
• the needles (33) may also be attached to the needle carrier (43) outside the distribution channel (48).
• the transdermal therapeutic system (10) When using the transdermal therapeutic system (10) this is placed with the needles (45) on the skin (2) of the patient and pressed so far until the support surface (24) rests on the skin (2) of the patient, see. FIG. 2.
• the adhesive layer (22) bonds the skin (2) to the transdermal therapeutic system (10).
• the advancing element (31) can contact the skin (2) of the patient.
• the needles (45) have penetrated the skin (2) of the patient.
• Skin layer (stratum corneum) and terminate outside the nerve endings of the deeper skin layers, so that the patient feels essentially no pain in de application.
• the advancing element (31) absorbs moisture from the skin (2).
• the volume of the swelling body (31) increases, cf. FIG. 3.
• fluid can be taken up from below the cornea. Since the system carrier (21) prevents or at least greatly reduces the free deformation of the Quefl stressess (31) due to its higher rigidity, the swelling body (31) can expand substantially only in the direction of the drug reservoir (41).
• the elastically deformable drug reservoir (41) is deformed and compressed. In this case, active ingredient (44) from the interior (46) of the drug reservoir (41) in the
• Liquid intake the liquid stored in the swelling body (31) and not delivered.
• the drug delivery is terminated when either the swelling body ⁇ 31) is expanded to its maximum volume or when all the active ingredient (44) from the
• Agent reservoir (41) in the direction of the skin (2) is displaced.
• the system carrier (21) projects into the interior space (28) with a punch (29).
• This stamp for example, has a cuboid cross-section and limits the laterally abutting it feed element ⁇ 31).
• the e.g. Matt-shaped feed element (31) has in this embodiment, a central recess (32) which engages around the punch (29).
• the pressure plate (61) is arranged above the active substance reservoir (41).
• the pressure plate (61) comprises a plate (62) with a reinforcing edge ⁇ 63). in the
• Embodiments are also on top of the plate (62)
• Diagonal ribs (64) arranged, which intersect in the middle of the top of the pressure plate ⁇ 61).
• the pressure plate (61) is designed indeterminate stiff and rigid.
• the pressure plate (61) may additionally be placed in an e.g. vertical
• liquid is also taken up in this embodiment from the skin surface or from the skin (2) by means of the advancing element (31).
• the expanding by means of fluid intake swelling body ⁇ 31) pushes the pressure plate (61) in the representation of Figure 5 down.
• the swelling body (31) is guided here on the system carrier (21) and on the punch (29).
• the pressure plate (61) is displaced at least approximately parallel and presses the drug reservoir (41) together.
• At a e.g. guided by a guide pin pressure plate (61) prevents the guide additionally tilting.
• the active ingredient (44) is largely uniform from the
• FIG. 6 shows a transdermal therapeutic system (10) with additional hollow needles (34). These hollow needles (34) are arranged parallel to the needles (45), which promote the active substance (44) into the skin (2).
• the number of hollow needles (34) is one fifth of the number of drug-promoting needles ⁇ 45).
• Hollow needles (34) whose tips (39) in the exemplary embodiment have the same dimensions as the active substance-promoting needles (45) penetrate the active substance reservoir (41). eg in sealed breakthroughs (49).
• the hollow needles (34) penetrate the feed element (31) and are supported in the representation of FIG.
• the hollow needles (34) have openings (35) penetrating their peripheral surface.
• the distance of the aperture (35) from the needle tip (39) is less than the reciprocal of the diameter of the cavity (37) in millimeters multiplied by an area of 25 square millimeters. For example, with a diameter of the cavity (37) of 0.5 millimeters results in the maximum distance to 50 millimeters.
• the fluid from the skin (2) rises due to the capillary action through the hollow needles (34) and enters the advancing element (31).
• the liquid penetrating causes an additional swelling of the swelling body (31) in the areas adjacent to the hollow needles (34). For example, the central section of the
• Agent reservoirs (41) are compressed earlier than in the embodiment of Figures 1-3.
• the hollow needle (34) penetrates the system carrier (21).
• a semipermeable membrane (36) is arranged, which closes the cavity (37) of the hollow needle (34) on the handling side (12). This semipermeable membrane (36) allows the
• the semipermeable membrane (36) may also be a check valve, etc. may be provided.
• FIGS. 8 and 9 show a transdermal therapeutic system (10) with an integrated liquid reservoir (71), eg a water reservoir (71).
• the liquid reservoir (71) eg a water reservoir (71).
• Water reservoir (71) is in the interior (28) of the system carrier (21) between the
• Feed element (31) is arranged in the illustrations of Figures 8 and 9, a grid (73). This grid (73) is anchored, for example, in the system carrier (21).
• the advancing element (31) bears on the water reservoir (71) facing side Aufrberichtdorne (38), which are initially spaced, for example, by a few tenths of a millimeter from the water reservoir (71).
• the needles (45) and the drug reservoir (41) against the system carrier (21) are moved.
• the active substance reservoir (41) displaces the advancing element (31) guided in the system carrier (21) in the direction of the water reservoir (71).
• the Aufr adopteddorne (38) contact the jacket (72) of the water reservoir (71) and tear the
• the grid (73) prevents expansion of the swelling body (31) in the direction of the system carrier (21).
• the swelling body (31) compresses the active substance reservoir (41).
• the active substance (44) is from the
• Agent reservoir (41) through the needles (45) through into the skin (2) pressed.
• tubular capillaries in the feed element (31). This can, in addition to the conveying effect of the material of the

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• Health & Medical Sciences (AREA)
• Engineering & Computer Science (AREA)
• Hematology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Veterinary Medicine (AREA)
• Anesthesiology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Vascular Medicine (AREA)
• Physics & Mathematics (AREA)
• Fluid Mechanics (AREA)
• Dermatology (AREA)
• Medical Informatics (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Infusion, Injection, And Reservoir Apparatuses (AREA)

Priority Applications (8)

Applications Claiming Priority (2)

Related Child Applications (1)

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Family Applications (1)

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Cited By (2)

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Citations (5)

Family Cites Families (12)

• 2013
  • 2013-08-23 EP EP13181516.9A patent/EP2839853A1/de not_active Withdrawn
• 2014
  • 2014-08-12 CA CA2914993A patent/CA2914993C/en active Active
  • 2014-08-12 WO PCT/EP2014/067238 patent/WO2015024816A1/de not_active Ceased
  • 2014-08-12 CN CN201480046318.1A patent/CN105473172A/zh active Pending
  • 2014-08-12 JP JP2016535414A patent/JP6581580B2/ja active Active
  • 2014-08-12 EP EP14750723.0A patent/EP3035977B1/de active Active
  • 2014-08-12 ES ES14750723T patent/ES2752465T3/es active Active
  • 2014-08-12 HK HK16104606.0A patent/HK1216512A1/zh unknown
  • 2014-08-12 BR BR112016000166-4A patent/BR112016000166B1/pt active IP Right Grant
• 2016
  • 2016-02-12 US US15/042,493 patent/US9895521B2/en active Active

Patent Citations (5)

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