U.S. patent application number 10/915792 was filed with the patent office on 2006-05-11 for needleless microprotrusion elastoplast system.
Invention is credited to Scott J. Gerondale, Robert T. Lyons, Orest Olejnik.
Application Number | 20060100584 10/915792 |
Document ID | / |
Family ID | 34981852 |
Filed Date | 2006-05-11 |
United States Patent
Application |
20060100584 |
Kind Code |
A1 |
Olejnik; Orest ; et
al. |
May 11, 2006 |
Needleless microprotrusion elastoplast system
Abstract
A needleless microprotrusion system for infusion of a medicament
into a patient includes a plurality of microprotrusions having a
length sufficient to penetrate a stratum corneum of the patient. A
chemodenervating agent is disposed in a microprotrusions in a
substrate is provided for supporting the microprotrusion and
conforming the microprotrusions to a selected patient body part in
order to enable uniform penetration of the microprotrusions into
the corneum.
Inventors: |
Olejnik; Orest; (Cato De
Caza, CA) ; Lyons; Robert T.; (Laguna Hills, CA)
; Gerondale; Scott J.; (Mission Viejo, CA) |
Correspondence
Address: |
WALTER A. HACKLER, Ph.D.;PATENT LAW OFFICE
SUITE B
2372 S.E. BRISTOL STREET
NEWPORT BEACH
CA
92660-0755
US
|
Family ID: |
34981852 |
Appl. No.: |
10/915792 |
Filed: |
August 10, 2004 |
Current U.S.
Class: |
604/173 ;
424/449 |
Current CPC
Class: |
A61M 2037/003 20130101;
A61M 37/0015 20130101; A61P 25/02 20180101; A61M 5/3007 20130101;
A61P 17/00 20180101; A61M 2037/0023 20130101 |
Class at
Publication: |
604/173 ;
424/449 |
International
Class: |
A61M 5/00 20060101
A61M005/00; A61K 9/70 20060101 A61K009/70; A61F 13/00 20060101
A61F013/00 |
Claims
1. A needleless microprotrusion system for infusion of a medicament
into a patient, the system comprising: a plurality of
microprotrusions having a length sufficient to penetrate a stratum
corneum of the patient; a chemodenervating agent disposed on
surfaces of the microprotrusions; a substrate for supporting the
microprotrusions, said substrate having a shape for conforming to a
selected patient body part in order to enable uniform penetration
of the microprotrusions into said stratum corneum.
2. The system according to claim 1 further comprising two
pluralities of microprotrusions, one plurality of microprotrusion
dispose on one side of said substrate and another plurality of
microprotrusion disposed on another side of said substrate.
3. The system according to claim 2 wherein said substrate is sized
for positioning within a palm of said patient.
4. The system according to claim 1 wherein said substrate is sized
and shaped for positioning against a palm and fingers of a
user.
5. The system according to claim 1 wherein said substrate is sized
and shaped for conforming to a patients' armpit.
6. The system according to claim 1 wherein said substrate is sized
and shaped for positioning against a sole of a users' foot.
7. The system according to claim 1 wherein said substrate is sized
and shaped for positioning against a sole and toes of a users'
foot.
8. The system according to claim 1 wherein said substrate is sized
and shaped for application to a glabellar region of said
patient.
9. The system according to claim 1 further comprising an adhesive
disposed on said substrate for temporary adhering said substrate to
a patients' skin.
10. The system according to claim 7 further comprising an adhesive
disposed on said substrate for temporary adhering said substrate to
a patients' skin.
11. The system according to one of claims 9 and 10 wherein said
adhesive surrounds said microprotrusion.
12. The system according to one of claims 1, 2, 3, 4, 5, 6, 7, 8,
9, and 10 wherein said substrate is flexible.
13. The system according to one of claims 1, 2, 3, 4, 5, 6, 7, 8,
9, and 10 wherein said chemodenervating agent is coated on said
microprotrusion.
14. The system according to claim 13 wherein said chemodenervating
agent comprises botulinum toxin.
15. The system according to one of claims 1, 2, 3, 4, 5, 6, 7, 8,
9, and 10 wherein said chemodenervating agent is disposed within
said microprotrusion.
16. The system according to claim 15 wherein said chemodenervating
agent comprises botulinum toxin.
17. A method for delivering a medicament to palms of a patient,
said method comprising: providing a substrate having a shape for
conforming to a palm of a patient, said substrate having
microprotrusion disposed on opposite sides of said substrate, said
microprotrusion having a length sufficient to penetrate a stratum
corneum of the patients' palm; providing a chemodenervating agent
for delivering by said microprotrusion; and instructing said
patient to dispose said substrate in one palm and press another
palm against the substrate in order to effect simultaneous delivery
of said chemodenervating agent into both palms.
18. The method according to claim 17 wherein said chemodenervating
agent comprises botulinum toxin.
19. The method according to one of claims 17 and 18 further
comprises providing a flexible substrate.
20. The method according to one of claims 17 and 18 further
comprising coating the microprotrusion with said chemodenervating
agent.
21. The method according to one of claims 17 and 18 further
comprising filling the microprotrusions with said chemodenervating
agent.
Description
[0001] The present invention is generally directed to a delivery
system for a medicament and is more particularly directed to a
needleless microprotrusion system for infusion of a medicament into
a patient.
[0002] Still more particularly, the present invention relates to a
novel method of administering chemodenervating agents in a
controlled and reproducible manner so as to confine effectiveness
of the agent to a given region while minimizing the effects of the
agent on adjacent tissue.
[0003] Chemodenervating agents such as, for example, botulinum
toxin, has been found effective for the treatment of hyperhidrosis
and other dermological indications, such as glabellar lines and
brow furrow. Current therapies include topicals, that is, for
example, antiperspirants, creams and systemic products. All to
often these are short acting and/or ineffective.
[0004] As noted, a significant advantage in ameliorating sweating
and removing wrinkle lines has been achieved through the action of
botulinum toxin injections. While this specific treatment is
revolutionary and efficacious, the patient is unfortunately placed
under significant amount of duress and discomfort due to need to
administer multiple injections.
[0005] In addition, since each injection represents a possibility
for infection, the injections are typically spaced apart from one
another, which results in peak and valley concentrations of the
medicament.
[0006] The epithelia layer of the skin, also referred to as the
epidermis, is a part of the skin which provides a barrier against
penetration and consists of four layers. These layers are an
outermost layer called the stratum corneum and three underlying
layers called the stratum granulosum, the stratum malpighii, and
the stratum germinativum.
[0007] The present invention provides for a system for intradermal
administration of neurotoxins in the treatment of hyperhidrosis,
skin wrinkles including facial lines.
SUMMARY OF THE INVENTION
[0008] The present invention provides for a needleless
microprotrusion system for infusion of a medicament into a patient
which includes a plurality of microprotrusions having a length
sufficient to penetrate a stratum corneum of the patient and a
chemodenervating agent disposed on or in the microprotrusions.
[0009] A substrate is provided for supporting the microprotrusions
with the substrate. The substrate features a shape for conforming
to a selected patient body part in order to enable uniform
penetration of the microprotrusions into the stratum corneum.
[0010] In one embodiment of the present invention, two pluralities
of microprotrusions are provided with one plurality of
microprotrusions disposed on one side of the substrate and another
plurality of microprotrusions disposed on another side of the
substrate.
[0011] A preferred shape for this embodiment includes a substrate
sized for positioning within the palm of a patient and preferably
the chemodenervating agent in accordance with the present invention
comprises botulinum toxin, preferably type A.
[0012] A method in accordance with the present invention utilizing
this embodiment basically includes the steps providing a substrate
having a shape for conforming to the palm of a patient with the
substrate having microintrusions disposed on opposite sides of the
substrates. The substrates have a length sufficient to penetrate
the stratum corneum of the patients' palm.
[0013] A chemodenervating agent is provided for delivery by the
microprotrusions and the patent is instructed to dispose the
substrate on one palm and press the other palm against the
substrate in order to effect simultaneous delivery of the
chemodenervating agent into both palms.
[0014] In another embodiment of the present invention a substrate
is size and shaped for conforming to a patients armpit and in yet
another embodiment of the present invention the substrate is sized
and shaped for application to a glabellar region of the
patient.
[0015] In addition, an adhesive disposed on the substrate may be
provided for temporarily adhering the substrate to a patients' skin
at a selected location and is suitable for receiving the size and
shape of the substrate.
[0016] To further enhance uniform penetration of the
microprotrusions into the stratum corneum, the substrate is
preferably flexible.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] The present invention may be more clearly understood with
reference to the following detailed description in conjunction with
the appended drawings, of which:
[0018] FIG. 1 is a side view of one embodiment of the present
invention generally showing two pluralities of microprotrusions
disposed on opposite sides of a substrate;
[0019] FIGS. 2 and 3 illustrate the use of the system shown in FIG.
1 which includes a substrate sized for positioning within the palm
of a user;
[0020] FIGS. 4-5 show other embodiments of the system in accordance
with the present invention utilizing a single plurality of
microprotrusions and a substrate for supporting the
microprotrusions and having a shape for conforming to a selected
body part along with an adhesive for temporarily adhering a
substrate to a patients' skin;
[0021] FIGS. 6 and 7 illustrate application of the embodiment shown
in FIGS. 4 and 5;
[0022] FIG. 8 shows an alternative embodiment of the present
invention in which the substrate is sized and shaped for fitting
the fossa axillaris (armpit) of a patient;
[0023] FIG. 9 shows and alternative embodiment of the present
invention in which the substrate is sized and shaped for
positioning against a users' palm and fingers;
[0024] FIG. 10 shows an alternative embodiment of the present
invention in whish the substrate is sized and shaped for
positioning against a users' sole and toes; and
[0025] FIG. 11 is an enlarge view of the microprotrusions shown in
FIGS. 1 and 4.
DETAILED DESCRIPTION
[0026] With reference to FIG. 1, there is shown a needleless
microprotrusion system 10 in accordance with the present invention
for infusion of a medicament (not shown) into a patient, also not
shown in FIG. 1.
[0027] The system 10 generally includes two pluralities 12, 14 of
microprotrusions 16, 18 disposed on opposite sides 20, 22 of a
substrate 24.
[0028] The microprotrusions 16, 18 may be of any suitable size and
configuration and formed from a metal, preferably stainless steel,
or other inert material that are directly embedded into the
substrate 22 which is preferably an inert platform such as
silicone, or polypropylene. With the proper selection of materials,
the microprotrusions and substrate may be formed unitarily.
[0029] A chemodenervating agent, preferably botulinum toxin, is
disposed on the microprotrusions 16, 18 and covered with a
removable liner 32 in a conventional manner, said liner being
removable for exposing the microprotrusions 16, 18 for use.
[0030] As more clearly shown in FIGS. 2 and 3, the substrate 22 is
sized and shaped for conforming to a patients' palm 36 which
enables a method in accordance with the present invention as
illustrated in FIG. 3 in which a patient, following instructions,
disposes the system 10 in one palm 36 and press another palm 38
against the system 10 in order to effect simultaneous delivery of
the chemodenervating agent into both palms 36, 38.
[0031] This method for delivering the medicament is suitable for
treatment of hyperhidrosis. Preferably, the substrate is flexible
for enabling uniform penetration of the microprotrusions 16, 18
into the patients' palms 36, 38 respectively. Microprotrusions
suitable for use in the present invention are described in U.S.
Pat. No. 6,322,808 which is to be incorporated herewith in its
entirety for a description of suitable microprotrusions 16, 18 and
substrates 24.
[0032] With reference to FIGS. 4 and 5, there are shown alternative
embodiments 44, 46 in accordance with the present invention which
further include exposed portions 48, 50 respectively which include
an adhesive for temporarily adhering the substrate portions 48, 50
to a patient, see FIGS. 6 and 7 respectively which illustrate
application of the embodiment 44 for removing wrinkles adjacent a
patients' eye and in a glabellar region of the patient.
[0033] In another embodiment 56 of the present invention as
illustrated in FIG. 8 in which a substrate 58 is sized and shaped
for fitting and conforming to a patients armpit 60.
[0034] FIGS. 9-10 are alternative embodiments 64, 66 illustrating
substrates 68, 70 respectively, which are sized and shaped for
positioning against a palm 74 and fingers 76 of a user and for
positioning against a sole 80 and toes 80 of a user. Various glove
sizes and shoe sizes may be used to produce embodiments 64, 66 for
use.
[0035] FIG. 11 is an enlarged view of the microprotrusions 16,
which as hereinabove noted, may be coated with botulinum toxin or
alternatively, filled with a solution including botulinum
toxin.
[0036] In this instance, a reservoir 90 may be provided behind the
microprotrusions 16 and covered by a backing 92 for enabling
pressure to be exerted on the reservoir for effecting delivery of
the botulinum toxin from the microprotrusion.
[0037] It should be appreciated that the length of the
microprotrusions are varied depending upon the anatomy of the
particular tissue being targeted by the therapeutic neurotoxin.
[0038] Although there has been hereinabove described a specific
needleless microprotrusion blastoplast system in accordance with
the present invention for the purpose of illustrating the manner in
which the invention may be used to advantage, it should be
appreciated that the invention is not limited thereto. That is, the
present invention may suitably comprise, consist of, or consist
essentially of the recited elements. Further, the invention
illustratively disclosed herein suitably may be practiced in the
absence of any element which is not specifically disclosed herein.
Accordingly, any and all modifications, variations or equivalent
arrangements which may occur to those skilled in the art, should be
considered to be within the scope of the present invention as
defined in the appended claims.
* * * * *