CN106061546A - Microneedle system and method for the production thereof - Google Patents
Microneedle system and method for the production thereof Download PDFInfo
- Publication number
- CN106061546A CN106061546A CN201580012129.7A CN201580012129A CN106061546A CN 106061546 A CN106061546 A CN 106061546A CN 201580012129 A CN201580012129 A CN 201580012129A CN 106061546 A CN106061546 A CN 106061546A
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- Prior art keywords
- contact pin
- pin grid
- wedge
- breach
- opening
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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- 238000004519 manufacturing process Methods 0.000 title claims abstract description 18
- 238000000034 method Methods 0.000 title claims description 6
- 238000005452 bending Methods 0.000 claims abstract description 12
- 239000000758 substrate Substances 0.000 claims description 34
- 239000004615 ingredient Substances 0.000 description 9
- 239000000463 material Substances 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 238000007493 shaping process Methods 0.000 description 4
- 238000003860 storage Methods 0.000 description 3
- 239000013536 elastomeric material Substances 0.000 description 2
- 238000004080 punching Methods 0.000 description 2
- 229910001566 austenite Inorganic materials 0.000 description 1
- 239000000969 carrier Substances 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 238000005260 corrosion Methods 0.000 description 1
- 230000007797 corrosion Effects 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 238000007373 indentation Methods 0.000 description 1
- 230000001788 irregular Effects 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000000630 rising effect Effects 0.000 description 1
- 238000010008 shearing Methods 0.000 description 1
- 230000003068 static effect Effects 0.000 description 1
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
- 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
- A61M2037/0046—Solid 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
- 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
- A61M2037/0053—Methods for producing microneedles
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Medical Informatics (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
The application relates to a method for producing a microneedle system (10), wherein from a board (21) is produced a web grating (41) which has a plurality of grating nodes (42) defined by in each case three apertures (22) and which has web grating wedges (51), and to a microneedle system comprising a board and a plurality of openings (31) delimited circumferentially by a web grating, wherein there is arranged at each opening at least one web grating wedge having a needle-shaped tip (56) which projects from the board and which is oriented at least approximately normal to the board. Web grating wedges having needle-shaped tips protrude into each aperture from at least three different directions. In order to produce openings, at least all the web grating wedges which protrude into an aperture are bent by means of a punch (72) and the needle-shaped tips thereof are oriented normal to the plane of the web grating. At least two web grating wedges are arranged at each opening, the bending lines of which are oriented non-parallel to one another. By virtue of the present application, the operational safety of a microneedle system is increased.
Description
Technical field
The present invention relates to a kind of method for manufacturing microneedle device, wherein, by substrate manufacture contact pin grid, these contact pin grid
Lattice are included multiple grid node limited by three breach respectively and include multiple contact pin grid wedge, and the present invention relates to
A kind of microneedle device, this microneedle device includes a substrate and includes multiple opening circumferentially defined by contact pin grid, its
In, each opening is provided with at least one contact pin grid wedge, described contact pin grid wedge includes that one is stretched out from contact pin grid
, the needle-shaped tip of the planar orientation being at least substantially perpendicular to contact pin grid, each contact pin grid wedge has a buckled zone, should
Buckled zone includes the sweep being parallel to the planar orientation of contact pin grid, and the quantity of needle-shaped tip is at least equal to the number of opening
Three times of amount.
Background technology
According to US2003/0199810A1, when manufacturing microneedle device, use the elastomeric material loaded by big punch die,
Described elastomeric material bends a tip respectively in each indentation, there.Before processing, all tips refer in same direction
To.If lateral load occurs in the application, then pin may bending.Microneedle device becomes unavailable.
According to DE69730971T2, the pin offset one from another can be set on opposed each side of breach.This embodiment party
In formula, lateral load is likely to cause the inefficacy of microneedle device.
Summary of the invention
The present invention proposes following problem: improve the safety in operation of microneedle device.
This problem proposed utilizes the feature of independent claims to solve.To this end, during fabrication, make that there is needle-shaped tip
Contact pin grid wedge stretches into each breach from the direction that at least three is different.In order to manufacture opening, at least make by punch die all
The contact pin grid wedge stretched in breach bending and make their needle-shaped tip be perpendicular to contact pin grid plane orientation.
The microneedle device so manufactured is constructed such that so that be provided with at least two contact pin grid wedge on each opening,
The sweep of described contact pin grid wedge is orientated the most not parallelly.Additionally, in contact pin grid, every one grid of three limited openings
Lattice node.
Accompanying drawing explanation
Other details of the present invention are drawn by dependent claims and the follow-up explanation to the embodiment schematically shown.
Fig. 1 illustrates the top view of substrate；
Fig. 2 illustrates the partial, longitudinal cross-sectional of Fig. 1；
Fig. 3 illustrates the details of Fig. 2；
Fig. 4 illustrates the substrate including breach；
Fig. 5 illustrates the dimetric drawing of Fig. 4；
Fig. 6 illustrates the details of Fig. 4；
Fig. 7 illustrates the modification of Fig. 6；
Fig. 8 illustrates second modification of Fig. 6；
Fig. 9 illustrates the 3rd modification of Fig. 6；
Figure 10 illustrates the manufacture of opening；
Figure 11 illustrates the top view of punch die system；
Figure 12 illustrates the top view of mold system；
Figure 13 illustrates the punch die of the substrate including shaping；
Figure 14 illustrates the dimetric drawing of substrate after such shaping.
Detailed description of the invention
Fig. 1 illustrates that top view and Fig. 2 illustrate the longitudinal section of microneedle device (10).Such microneedle device (10) is used for
Effective ingredient is introduced the internal of patient through skin from the effective ingredient storage room being not shown here.
Described effective ingredient storage room is arranged on effective ingredient carrier (11).Described effective ingredient carrier (11) has one
Individual substrate (21), described substrate has a contact pin grid (41), multiple opening (31) and multiple pin (55).In this embodiment
In, it is provided with in substrate (21) more than 30 openings (31).Each opening (31) is defined by eight pins (55).Each pin (55) has
There is a tip (56).In the illustrated embodiment, opening (31) has the profile of closing.The most described opening is in basic configuration
Aspect has octagonal structure, and described octagonal angle (32) is arranged between each pin (55).Described basic configuration also may be used
To be regular or irregular triangle, quadrangle, hexagon etc..It is also contemplated that as circular, oval, avette etc. base
The embodiment of this shape.
In the illustrated embodiment, substrate (21) has the length of 20 millimeters and the width of 20 millimeters.Angle is with five millimeters
Angular radius rounding.The thickness of described substrate (21) is 0.1 millimeter.Described substrate is in this embodiment by austenite, rust-proofing
Make with acidproof material.This e.g. material number is the X5CrNi18-10 of 14301.
67 openings (31) it are provided with in the substrate (21) shown in Fig. 1.The cross-sectional area summation of all openings (31) is at this
Embodiment is substrate (21) basal plane area 40%.The cross-sectional area summation of all openings (31) is therefore more than substrate (21)
Basal plane area 30%.
Described opening (31) is surrounded by contact pin grid (41).Every three openings (31) limit a grid node (42).?
In each grid node (42), three contact pin (43) T-shaped it is connected with each other.
Contact pin grid (41) is in a plane, and contact pin grid wedge (51) is perpendicular to this plane earth and highlights from this plane.
In the view of Fig. 2, described contact pin grid wedge is downwardly projected.Each contact pin grid wedge (51) has one and is connected to contact pin grid
(41) buckled zone (52) on and a pin (55), with reference to Fig. 3.The tip (56) of each pin (55) is configured to relative to contact pin grid
The longitudinal plane symmetry of the central authorities through opening (31) axis (33) along substrate thickness direction orientation of lattice wedge (51).Each connects
The thickness of sheet grid wedge (51) is equal to the thickness of substrate (21).Buckled zone (52) has constant bending radius, described bending half
Footpath is such as equal to the thickness of contact pin grid wedge (51).Contact pin grid wedge (51) the most at least with the 80% of their length from contact pin
Grid (41) highlights.In this embodiment, pin (55) at least stretches out from contact pin grid (41) with 0.6 millimeter.
Opening (31) is provided with at least three contact pin grid wedge (51).In the present embodiment, each described opening (31)
Defined by contact pin grid wedge (51) of equal number.The sweep (53) of at least two contact pin grid wedge (51) is in different directions
Point to.The two sweep has an intersection point.In this embodiment, the straight sweep of each two buckled zone (52) has phase
Same direction.
The manufacture of microneedle device (10) illustrates in figs. 4-6 and in figures 10-14.Raw material is e.g. by above-mentioned material system
The flat substrate (21) of the constant thickness become.In this embodiment, this substrate has the square basal plane at the angle with rounding.Substrate
(21) can also be configured to circle, angular, oval etc..
First breach (22) is introduced in this sheet material.This is carried out by punching press, cut, corrosion etc..Each breach
(22) such as it is arranged in adjacent row as illustrate in figures 4 and 5.Each row offsets one from another with a point position for half.Often
The centrage (23) of three breach adjacent one another are (22) forms a wedge with the equilateral triangle as basal plane.Here,
Two adjacent breach (22) centre distance each other with 15% more than the circle diameter of a single breach (22).
Fig. 6 illustrates the details of breach (22).This breach there is middle section (24) and such as eight set radial to centrage
Breach section (25) that put, that expand outwardly.Each described breach section (25) is symmetrical relative to the radius of breach (22), its
In, each described radius angle (26) outside with of breach (22) is intersected.
Such as after stamping-out, initial substrate (21) remains with contact pin grid (41) and breach section (25) it
Between remain with contact pin grid wedge (51).Such as in the top view of Fig. 6, it is arranged on breach for contact pin grid wedge (51) of triangle
(22) stretch out from contact pin grid (41) between each angle (26) and with the length of such as 0.75 millimeter.Each contact pin grid wedge
(51) width is 0.3 millimeter in this top view.In described top view, in this embodiment, all contact pin grid wedges
(51) area is the 34% of the area of the basic configuration determined by angle (26) of breach (22).All contact pin grid wedge (51)
Area be breach (22) at this between the 25% to 50% of the most octagonal basic configuration.Based on this dimension scale,
The danger damaging contact pin grid wedge (51) is there is not when manufacturing breach (22).
Each breach (22) is so arranged each other so that contact pin grid wedge (51) is not mutually aligned.Top view at Fig. 4
In, in each gap, breach section is mutually aligned.In adjacent gap, contact pin grid wedge (51) is adjacent to one
Arrange breach section (25).
Fig. 7-9 illustrates multiple modification of the structure of breach (22).In the figure 7, the basic configuration of breach (22) has ten
Angle (26).This basic configuration includes that contact pin grid wedge (51) is relative to the longitudinal plane symmetry of the central authorities of breach (22).In this enforcement
In example, each contact pin grid wedge (51) is also disposed between two angles (26) of breach (22).Replace angle (26), it is also possible in institute
State and between contact pin grid wedge (51), arch is set.
The breach (22) that figure 8 illustrates has two long limits opposite each other (27,28).A long limit (27) wherein
It is provided with single contact pin grid wedge (51).Go up on another long limit (28) and this arranges two contact pin grid wedges with staggering
(51)。
Fig. 9 illustrates the breach including six contact pin grid wedge (51).Each two contact pin grid wedge (51) is in this top view
Point on a common point of vertical central fore-and-aft plane.Replace angle (26), set between each contact pin grid wedge (51)
Put arcuate member (29).
Substrate (21) including breach (22) is such as put in bending press, with reference to Figure 10.Bending press has a mould
Tool system (61) and a punch die system (71).With reference to Figure 12, mold system (61) has multiple space in this embodiment
(62).The quantity in described space (62) is equal to the quantity of the breach (22) of substrate (21).The cross section in single space (62) is eight
Dihedral.There is rounding (63), referring also to Figure 10 on space (62) edge thereon.This rounding (63) has such as 0.2 millimeter
Radius.The cross-sectional area of the inside in space (62) is less than the cross-sectional area of the basic configuration of breach (22) with rounding (63).
With reference to Figure 11, punch die system (71) has multiple punch die (72).These are in this embodiment with the punch die of type
(72) there is octagonal cross section in this embodiment.Spanner mouth aperture (Schl ü sselweite) is such as than mold system
(61) double thickness of substrate (21) that the correspondingly-sized in space (62) is narrow.The tip (73) of each punch die (72) is configured to
The pyramidal frustum bodily form.Tip angle for example, 30 degree.
In bending press, punch die system (71) is to mold system (61) closing motion.Substrate (21) is such as by compression
Device is maintained in its position.Punch die (72) contacts contact pin grid wedge (51) and sinks in mould (62).Here, contact pin grid
Wedge (51) bends along the rounding (63) of corresponding mould (62).Described shaping can cold or thermally be carried out.Corresponding buckled zone
(52) there is a straight sweep (53).All of sweep (53) is in a common plane, and described plane is parallel
Plane in the upside (44) of contact pin grid (41).The sweep (53) of contact pin grid wedge (51) therefore has four different sides
To.Region deformation adjacent one another are is not made because of arrangement based on breach (22) and orientation, so contact pin grid
(41) its static strength is kept.The bending that there is not contact pin grid wedge (51) is dangerous.Simple for geometry instrument can be used
In producing breach (22) and being used for shaping.Each breach (22) is the most only used to a unique punch die (72).By this
Punch die (72), manufactures all such as eight pins (55) in a unique punch die stroke from contact pin grid wedge (51).
When punch die (72) sinks in mould (62) further, contact pin grid wedge (51) deforms further, until described punching
Mould is perpendicular to the plane of contact pin grid (41) and stretches out.The tip (56) of contact pin grid wedge (51) is now towards deviating from contact pin grid (41)
Plane direction point to.This figure 13 illustrates.According to manufacturing process, can be by punch die (72) in the predetermined time interval phase
Between be maintained in this position or make contact pin grid wedge (51) slightly excess stretch.
Contact pin grid wedge (51) forms pin (55) now, and described pin surrounds opening (31) and downwards in the view of Figure 14
Stretch out.Such as pin (55) stretches out from contact pin grid (41) with the length of 0.6 millimeter.In the embodiment of Figure 14, by above-mentioned chi
In the case of based on very little, the substrate area of every square millimeter arranges 1.2 pins.Made by the substrate (21) according to Figure 4 and 5
In the microneedle device (10) made, every square millimeter of substrate area arranges 1.4 pins (55).The area of references openings (31), at this
In embodiment, every square millimeter of open cross-sectional area has at least three pin (55) and most advanced and sophisticated (56).The gross area example of opening (31)
As bigger than the 30% of the basal plane area of substrate (21).
In order to use microneedle device (10), described microneedle device is installed to patient together with the effective ingredient storage room set assembled
Skin on and thrust in described skin.Here, user applies the power being substantially orientated along the direction of pin (55).Pin (55)
Overcome the resistance of upper skin layer and thrust in skin.The resistance of such as skin and/or the power of deflection applied by user can
The shearing force being applied on pin (55) can be caused.
The different direction of sweeps based on each pin (55) (53), does not exists when using described microneedle device (10)
The bending of pin (55) or the danger of bending.All pins (55) therefore thrust in the skin of patient.
After application microneedle device (10), effective ingredient thrusts the skin of tensioning micropin (55) through opening (31)
In skin.Here, the gross area of opening (31) is the biggest with the ratio of the basal plane area of substrate (21), then the volume flow of effective ingredient
The biggest.Such as rising along with ratio, volume flow the most proportionally raises.The layout along closed outline based on pin (55)
Structure, can be in the case of the pin (55) of equal number, and be chosen as by the area of contact pin grid (41) than opening (31) is total
Area is little.This factor such as can be less than 2.5.
In order to manufacture microneedle device (10), only need two workflows.In two workflows, each instrument is implemented respectively
One unique stroke motion.Microneedle device (10) therefore can quickly and without problems be made.Described microneedle device is the most right
It is applicable in a large amount of production.
It is also recognized that the different embodiments mentioned are mutually combined.
Reference numerals list
10 microneedle devices
11 effective ingredient carriers
21 substrates
22 breach
23 centrages
24 middle sections
25 breach sections
26 jiaos
27 long limits
28 long limits
29 arcuate member
31 openings
32 jiaos
33 axis
41 contact pin grids
42 grid nodes
43 contact pin
On the upside of in the of 44
51 contact pin grid wedges
52 buckled zones
53 sweeps
55 pins, micropin
56 most advanced and sophisticated, needle-shaped tip
61 mold systems
62 spaces, mould
63 roundings
71 punch die systems
72 punch dies
73 punch dies are most advanced and sophisticated
74 stroke directions
75 longitudinal seamed edges
76 die faces
Claims (7)
1. the method being used for manufacturing microneedle device (10), wherein,
-being manufactured contact pin grid (41) by substrate (21), this contact pin grid includes multiple being limited by three breach (22) respectively
Grid node (42) and include multiple contact pin grid wedge (51),
-make each contact pin grid wedge (51) with needle-shaped tip (56) stretch into each breach (22) from the direction that at least three is different
In, and
-in order to manufacture opening (31), at least make whole contact pin grid wedge (51) stretched in breach (22) by punch die (72)
Bending and the plane making their needle-shaped tip (56) be perpendicular to contact pin grid (41) orient.
2. the method manufacturing microneedle device (10) according to being used for described in claim 1, it is characterised in that punch die (72) has edge
Longitudinal seamed edge (75) that its stroke directions (74) is orientated, wherein, each two longitudinal direction seamed edge (75) defines a smooth die face
(78)。
3. the method manufacturing microneedle device (10) according to being used for described in claim 1, it is characterised in that will have breach (22)
Substrate (21) be placed on mold system (61), described mold system includes that at least one has the space of polygonal crosssection
(62)。
4. microneedle device (10), including a substrate (21) and include multiple opening circumferentially defined by contact pin grid (41)
(31), wherein,
Being provided with at least one contact pin grid wedge (51) on each opening (31), described contact pin grid wedge includes one from contact pin
That grid (41) stretches out, be at least substantially perpendicular to the needle-shaped tip (56) of the planar orientation of contact pin grid (41),
Each contact pin grid wedge (51) has a buckled zone (52), and this buckled zone includes the plane being parallel to contact pin grid (41)
The sweep (53) of orientation, and
The quantity of needle-shaped tip (56) at least equal to three times of quantity of opening (31),
It is characterized in that,
-on each opening (31), it is provided with at least two contact pin grid wedge (51), the sweep (53) of described contact pin grid wedge
It is orientated the most not parallelly, and
-in contact pin grid (41), every three openings (31) limit a grid node (42).
5. according to the microneedle device (10) described in claim 4, it is characterised in that total cross-sectional area of opening (31) is at least base
The 30% of plate basal plane area.
6. according to the microneedle device (10) described in claim 4,
It is characterized in that, the sweep (53) of contact pin grid wedge (51) that each two is adjacent is just intersecting at a point.
7. according to the microneedle device (10) described in claim 4,
It is characterized in that, all needle-shaped tip (56) are all parts for pin (55), and these parts the most substantially have identical length
Degree.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DE141544817 | 2014-02-10 | ||
| DE14154481.7 | 2014-02-10 | ||
| PCT/EP2015/052150 WO2015117938A1 (en) | 2014-02-10 | 2015-02-03 | Microneedle system and method for the production thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN106061546A true CN106061546A (en) | 2016-10-26 |
Family
ID=57484338
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201580012129.7A Pending CN106061546A (en) | 2014-02-10 | 2015-02-03 | Microneedle system and method for the production thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN106061546A (en) |
Cited By (4)
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|---|---|---|---|---|
| CN111918691A (en) * | 2018-03-30 | 2020-11-10 | 实验室和人们 | Multifunctional microneedle |
| CN112423828A (en) * | 2018-05-18 | 2021-02-26 | 浦项工科大学校产学协力团 | Transdermal drug delivery patch and method for producing same |
| CN112423829A (en) * | 2018-05-18 | 2021-02-26 | 浦项工科大学校产学协力团 | Transdermal drug delivery patch and method for producing same |
| CN112891724A (en) * | 2020-12-28 | 2021-06-04 | 上海交通大学 | Micro-needle array with plastic micro-bending and preparation method thereof |
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| CN111918691A (en) * | 2018-03-30 | 2020-11-10 | 实验室和人们 | Multifunctional microneedle |
| CN112423828A (en) * | 2018-05-18 | 2021-02-26 | 浦项工科大学校产学协力团 | Transdermal drug delivery patch and method for producing same |
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