WO2002100476A2 - Device for manipulating a needle or abrader array - Google Patents
Device for manipulating a needle or abrader array Download PDFInfo
- Publication number
- WO2002100476A2 WO2002100476A2 PCT/US2002/018024 US0218024W WO02100476A2 WO 2002100476 A2 WO2002100476 A2 WO 2002100476A2 US 0218024 W US0218024 W US 0218024W WO 02100476 A2 WO02100476 A2 WO 02100476A2
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- top wall
- reservoir
- projecting
- substance
- stractures
- Prior art date
Links
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
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/20—Surgical instruments, devices or methods, e.g. tourniquets for vaccinating or cleaning the skin previous to the vaccination
- A61B17/205—Vaccinating by means of needles or other puncturing devices
-
- 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
-
- 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
- A61M2037/003—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a lumen
-
- 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
- A61M2037/0038—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a channel at the side surface
Definitions
- the invention relates to a new and useful apparatus for delivering a substance to a
- the apparatus of the present invention includes a microabrader or microneedle
- a device which may include a reservoir containing a pharmaceutically active compound for
- Transdermal, or percutaneous, administration of pharmaceutical compounds is a known method of delivering drug compounds, or other agents, through the skin and into the
- stratum corneum The stratum corneum is a heterogeneous layer of flattened, relatively dry keratinised cells which limits the rate at which such agents
- stratum corneum contains. Once a compound has penetrated the stratum corneum, which is approximately 15 microns thick, when dry, and expands to approximately 47 microns in thickness when
- epidermal layers The remaining epithelial layers of the skin ⁇ the stratum granulosum, the
- stratum malpighii and the stratum germinativurn - provide little, if any, resistance to the transmission of pharmaceutical compounds. Accordingly, once the stratum corneum has been penetrated, topically administered pharmaceutical agents are adsorbed through the lower epithelial layers and are able to enter into the circulatory system through the
- corneum for the purpose of delivering substances to the body. For example, breach of the
- stratum corneum may be achieved by puncturing as taught in US Patent 5,679,647 to Carson, et al. This patent teaches that narrow diameter tines, such as those found on
- devices used for tuberculin skin tests and allergy tests can be coated with polynucleotides
- a method and device for administering a substance to a mammal are provided by
- the device can comprise a top or upper surface or wall, a bottom surface or wall spaced apart from said top surface or wall.
- the bottom surface or wall has a substantially planar outer surface from which a plurality of projecting structures extend
- One or more side walls may join with the top and bottom walls to define in the space between them a reservoir for a substance that is to be delivered to the mammal.
- the device also comprises a manipulating member which is attached to at least one of the walls or surfaces of the device.
- the manipulating member extends outward from the surface or
- the manipulating member may also be an extension of one or more
- walls or surfaces of the device and may even be molded as a single, unit body with the
- At least one passageway also extends from the reservoir to the projecting structures on the exterior of the device.
- the passageway or passageways may also extend through the projecting structures themselves.
- the device also comprises a at least one deformable
- deformable member may be one of the device walls or surface, the manipulating member
- the device also has
- Figure 1 is a side view in cross section of an embodiment of the present invention showing a finger-cup attached to a microdevice which includes an array of microneedles;
- Figure 2 is a side view in partial cross-section of the embodiment of Figure 1
- Figure 3 is a cross-sectional side view of another embodiment of the present invention.
- the microdevice includes an array of microabraders projecting outwardly from the planar
- Figure 4 is an end view in cross-section of the device of Figure 3;
- Figure 5 is a cross-sectional side view of another embodiment of the present invention.
- Figure 6 is an end view in cross-section of the embodiment of Figure 5;
- Figure 7 is a front view of another embodiment of the present invention showing a
- microdevice coupled to a microdevice, where the microdevice includes a top wall and a bottom
- Figure 8 is a cross-sectional side view of the embodiment of Figure 7 showing a microdevice with a solid handle extending outwardly from the top wall of the microdevice.
- the present invention is directed to a method and device for delivering a substance through the skin of a patient.
- the following description of the invention primarily relates to drug delivery devices.
- the present invention is directed to a method and apparatus for delivering a
- One aspect of the invention is directed to a device
- present invention is a device which has a top wall and a bottom wall separated and joined
- a substantially planar surface on the bottom wall with a plurality of projecting structures which can include either micron-sized penetrating members such as microneedles or micron-sized abrading members.
- the projecting structures can range in length and width from less than 1 micron to several hundred microns.
- the projecting structures can be solid or hollow.
- the reservoir may also include an axial passageway or channel from the reservoir to the projecting structures for conducting a substance from the reservoir to the projecting structures
- the substance can be delivered through the stratum corneum and to the lower epithelial
- the passageway or channels maybe singular or multiple and may be located in or through one or more projections or on the substantially planar surface that
- the present invention is contemplated for use with mammalian patients.
- the microdevice has an extension to permit the manipulation of the microdevice by the user.
- the extension can be a stick-like elongated
- manipulation member such as a handle, finger-cup, or any other configuration that allows
- the manipulation member may also contain a fluid reservoir that is either in fluid communication with an array of microneedles
- the manipulation member is used to position the projecting structures
- manipulation member enables one to control the microdevice when moving the array of
- microneedles or abrading structures in a manner that penetrates or scores the stratum
- a substance, such as a pharmaceutical agent, is stored in a reservoir, it may also be
- the microdevice includes a thimble-like
- the thimble- like element of the device has an open end for inserting a finger and the projecting structure
- a reservoir is disposed with one side in fluid coimnunication with the projecting structures.
- the opposite side, or the adjacent sides may be deformable such as
- the aspects of the invention are basically attained by providing a device for
- the device comprises a top wall and a handle attached to the top wall and extending outward therefrom.
- the handle has a dimension
- a bottom wall is spaced apart from the top wall and has a
- top wall, bottom wall and side walls define a reservoir for the substance to be delivered into and through the skin of a
- the aspects of the invention are also attained by providing a device for delivering a
- the device comprises a top wall, a finger-cup attached to the top wall and extending outward therefrom, and a bottom wall spaced apart from the top wall and having a planar outer surface. Projecting structures extend outward
- bottom wall and side walls define a reservoir for the substance to be delivered to a patient.
- the aspects of the invention are further attained by providing a method of delivering a substance through the skin of a patient. A microdevice is placed in contact
- the microdevice comprises a planar surface having a plurality of
- a top wall is spaced apart from the
- a manipulating member is attached to the top wall. A sufficient force is applied to the microdevice to cause the projecting structures to penetrate the stratum comeum layer of the skin. The substance is dispensed from the reservoir to the
- the present invention relates to a microdevice with a structure for gripping or holding the microdevice during use.
- the microdevice of the present invention enables the person using the device to accurately and conveniently position and operate the
- the stratum corneum can be abraded or pierced without the need for the application of excess pressure to the microdevice.
- microdevice when appropriately sized will penetrate the epithelial layer to a depth no
- predetermined pressure threshold is the delivery of the substance from the reservoir accomplished.
- a deformable manipulating member for example,
- pressure sensitive threshold could be set by use of a substance retaining membrane or a
- FIG. 1 is a microdevice 10 as shown in Figure 1 includes a body 12 which has a top wall 20 and a bottom wall 30 spaced apart from the top wall 20 and joined by side walls 32. The interior region created by the intersection of the top wall
- bottom wall 30 and side walls 32 defines a reservoir 40 for storing a substance 42 to be
- the substance is a pharmaceutical composition in a liquid
- the body 12 may also be made up only one, or more, wall(s) that are a formed as a
- top and side, or as part of another piece of the device. Attached to top wall 20 and extending outwardly is a finger-cup 50 to receive and
- finger-cup 50 is an elastic thimble-like member made
- Finger-cup 50 is a tubular shaped member having a side wall 52 for encircling the finger of a user and an open top end 54. A bottom end 55 of
- top wall 20 forms
- finger-cup 50 can have a bottom wall that overlies top wall 20.
- the microdevice 10 is able to be precisely
- the finger- cup 50 may be formed in a manner which is specific to the fingers of a left hand or right
- Bottom wall 30 of the microdevice 10 has an outwardly facing planar surface
- the projecting stractures 58 can be assembled
- the projecting stractures 58 extend outwardly and
- Fluid conducting passageways 60 are preferably included within each projecting structure 58 in the form of
- passageways 60 are open on each end to allow fluid communication between the reservoir
- the tips 62 of the projecting stractures 58 have a length to penetrate the skin slightly beneath the stratum
- the fluid conducting passageways 60 permit the flow of the substance 42 from
- the projecting structures are solid and the passageway, or multiple passageways, opens from the interior of the reservoir to the base of the projecting structures
- Body 12 is preferably made of a suitable plastic material, but can be any material
- Top wall 20 is preferably flexible or deformable so as
- bottom wall 30 is generally stiff to promote uniform penetration of projecting stractures 58.
- bottom wall 30 is flexible to conform to the surface of the skin of the patient.
- one or more of the side walls are deformable.
- the tip of a finger 64 is inserted into the open top end 54 of finger-cup
- the elasticity of the finger-cup 50 firmly secures the finger 64 within the finger-cup 50
- microdevice 10 has
- cup 50 applies an additional amount of pressure against the top wall 20 of the microdevice 10.
- the projecting stractures 58 are microneedles as shown in Figure 2, application
- stractures 58 is greater than the thickness of the stratum comeum, the tips 62 of the projecting structures 58 will pierce the stratum corneum.
- penetrating refers to entering the stratum comeum without passing completely through the stratum comeum and entering into the adjacent layers. This is not to
- top wall 20 The downward pressure on top wall 20 by finger 64 deflects top wall 20 inwardly as
- reservoir 40 is discharged through the fluid conducting passageways 60 and absorbed by
- the length and thickness of the projecting structures 58 are selected based on the particular substance being administered and the thickness of the stratum comeum in the location where the device is to be applied. Preferably, the projecting structures 58 penetrate
- the projecting stractures 58 can have a length up to about 1.5 millimeters.
- Suitable projecting stractures 58 have a length of about 5 to 500 microns.
- the first projecting stractures 58 have a length of about 5 to 500 microns.
- projecting structures 58 have a length of about 50 to about 300 microns, and more preferably in the range of about 75 to 250 microns, with 180 to 220 microns most
- the projecting stractures 58 are either hollow or solid
- the projecting structure are microneedles it is envisioned that the lengths will generally be larger, for example 0.9 mm to 1.5 mm.
- the device 10 is moved in a back and forth or circular pattern to abrade the skin sufficiently to enable projecting stractures 58 to penetrate the skin to a desired depth.
- a continued downward pressure flexes top wall 20 to dispense the
- projecting stractures 58 are knife-like blades or other
- stractures such as pyramidal or frustoconical in shape, which are preferably perpendicular
- microdevice 10 may need to be moved in a reciprocating manner to penetrate the stratum comeum, precise handling of microdevice 10 through the use of the attached finger-cup 50
- a body 82 having a top wall 84, bottom wall 86 and side walls 88
- a handle 92 is attached to top wall 84 and has a dimension to enable the user to grip and manipulate the device 80.
- the depicted embodiment shows
- handle 92 being hollow and attached to the periphery of top wall 88. hi a preferred
- handle 92 is made of a resilient, flexible and deformable material such as for example rubber, plastic, thin metal sheet, or combinations thereof. Handle 92 in the
- handle 92 has a hollow cavity 93 formed by side walls 95 and a top wall 97.
- handle 92 has an open bottom end that is closed by the attachment to top wall 84. In another preferred embodiment, handle 92 is closed at both ends.
- a plurality of projecting structures 94 extend from bottom wall 86 to form an array.
- projecting stractures 94 have a length and width that is sufficient to penetrate the skin to a selected depth for delivering a substance into and
- each projecting structure 94 includes an axial
- top wall 84 is attached to top wall 84 in a manner which is air-tight to form hollow cavity 93.
- side walls 95 deflect inwardly to
- top wall 84 dispenses the top wall 84
- a person is able to administer a substance, such as a pharmaceutical
- composition to a patient with device 80 by grasping the handle 92 and precisely
- the handle 92 is used to apply gentle
- the handle 92 is squeezed to compress fluid air contained in the handle and to produce an additional amount of pressure on top wall 84 to
- deflect top wall 84 in a manner to reduce the volume of the reservoir 90 and to discharge the pharmaceutical composition stored within the reservoir 40 through fluid conducting
- a delivery device 100 includes a
- Base 104 includes a bottom wall 106 and side walls 108.
- a plurality of projecting stractures 110 arranged in an array extend from bottom wall
- Projecting structures 110 in the embodiment illustrated, are microneedles having an
- Base 104 also includes a top wall
- Handle 102 is a hollow structure formed by side walls 118 and a top wall 120 to form an internal cavity 119. Handle 102 has an open bottom end 122 so that cavity 119 is in direct fluid communication with reservoir 116. As in the previous embodiment, handle
- cavity 119 can contain a substance 125 to be delivered to the patient. Deflecting side walls 118 inwardly
- Operation of the device 100 of this embodiment of the invention is substantially the same as the operation of the embodiment shown in Figure 3, but offers an alternative configuration suitable for instances where a larger volume reservoir is desired.
- FIGS 7 and 8 show another embodiment of a delivery device 126 of the present
- body 128 having a deformable top wall 129 spaced apart from a bottom
- top wall 129, bottom wall 130 and side walls 132 define a reservoir 134.
- a solid manipulating member 136 such as a handle, is coupled to top wall 129.
- handle 136 is a solid, elongated member having a dimension to provide a
- the person administering treatment can exercise accurate control over device 126 while minimizing
- Bottom wall 130 has
- top wall 128 is sufficiently flexible to flex inwardly to dispense a substance 140 from reservoir 134 through axial passages 142 of projecting stractures 140.
- handle 136 can be pressed downwardly in the direction of arrow 144 to deflect top wall 129 as shown in phantom lines of Figure 8. As in the
- device 126 can be pressed downwardly against skin 146 to cause
- 126 can be rubbed against skin 146 in a target site to abrade skin 146 to a depth to allow substance 140 to penetrate skin 146 below the stratum corneum.
- the substance to be delivered is physically retained within the reservoir, such as for example, by at least one ruprurable membrane.
- This retaining membrane may be as simple as a ruprurable material overlaying, or adjacent to the fluid passageway or passageways, or an enclosing bladder. Other ways of retaining
- timing of the deliver of the substance to the mammal is also within the scope and spirit of this invention. This delivery can occur prior to, concurrent with and after the penetration of the proj ecting members.
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Surgery (AREA)
- Medical Informatics (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Dermatology (AREA)
- Anesthesiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Hematology (AREA)
- Molecular Biology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Finish Polishing, Edge Sharpening, And Grinding By Specific Grinding Devices (AREA)
- Medicinal Preparation (AREA)
- Knitting Machines (AREA)
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP02739746A EP1395328B1 (en) | 2001-06-08 | 2002-06-07 | Device for manipulating a needle or abrader array |
JP2003503292A JP2004532698A (en) | 2001-06-08 | 2002-06-07 | Equipment for operation of needle or abrader arrays |
AU2002312380A AU2002312380A1 (en) | 2001-06-08 | 2002-06-07 | Device for manipulating a needle or abrader array |
DE60213976T DE60213976T2 (en) | 2001-06-08 | 2002-06-07 | DEVICE FOR MANIPULATING NEEDLES OR POLISHING ARRAY |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US29710101P | 2001-06-08 | 2001-06-08 | |
US60/297,101 | 2001-06-08 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO2002100476A2 true WO2002100476A2 (en) | 2002-12-19 |
WO2002100476A3 WO2002100476A3 (en) | 2003-02-27 |
Family
ID=23144859
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US2002/018024 WO2002100476A2 (en) | 2001-06-08 | 2002-06-07 | Device for manipulating a needle or abrader array |
Country Status (8)
Country | Link |
---|---|
US (2) | US7186235B2 (en) |
EP (1) | EP1395328B1 (en) |
JP (1) | JP2004532698A (en) |
AT (1) | ATE336276T1 (en) |
AU (1) | AU2002312380A1 (en) |
DE (1) | DE60213976T2 (en) |
ES (1) | ES2268050T3 (en) |
WO (1) | WO2002100476A2 (en) |
Cited By (13)
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WO2005065765A1 (en) * | 2003-12-29 | 2005-07-21 | 3M Innovative Properties Company | Medical devices and kits including same |
WO2005072630A1 (en) | 2004-01-30 | 2005-08-11 | Isis Innovation Limited | Device for delivery of bioactive materials and other stimuli |
FR2875704A1 (en) * | 2004-09-29 | 2006-03-31 | Pierre Fabre Medicament Sa | PACKAGING DEVICE FOR THE TOPICAL APPLICATION OF AN ACTIVE INGREDIENT |
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Also Published As
Publication number | Publication date |
---|---|
DE60213976D1 (en) | 2006-09-28 |
EP1395328B1 (en) | 2006-08-16 |
DE60213976T2 (en) | 2007-04-26 |
US7186235B2 (en) | 2007-03-06 |
US20020188245A1 (en) | 2002-12-12 |
AU2002312380A1 (en) | 2002-12-23 |
ATE336276T1 (en) | 2006-09-15 |
WO2002100476A3 (en) | 2003-02-27 |
ES2268050T3 (en) | 2007-03-16 |
JP2004532698A (en) | 2004-10-28 |
EP1395328A2 (en) | 2004-03-10 |
US20070118073A1 (en) | 2007-05-24 |
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