U.S. patent application number 11/594825 was filed with the patent office on 2008-01-17 for puncture device.
This patent application is currently assigned to Terumo Kabushiki Kaisha. Invention is credited to Tetsuro Kawanishi, Atsushi Matsumoto, Yutaro Sonoda.
Application Number | 20080015624 11/594825 |
Document ID | / |
Family ID | 38005815 |
Filed Date | 2008-01-17 |
United States Patent
Application |
20080015624 |
Kind Code |
A1 |
Sonoda; Yutaro ; et
al. |
January 17, 2008 |
Puncture device
Abstract
The present invention provides a puncture device and an
administration device in which a puncture needle can be stuck
certainly to a predetermined region of a skin. The puncture device
and the administration device of the present invention are provided
with a puncture needle moving means for retaining aforesaid
puncture needle to be movable and a skin deforming means for
deforming the skin, wherein it is constituted such that the
puncture needle is moved by aforesaid puncture needle moving means
and punctures the skin deformed by aforesaid skin deforming
means.
Inventors: |
Sonoda; Yutaro;
(Ashigarakami-gun, JP) ; Kawanishi; Tetsuro;
(Ashigarakami-gun, JP) ; Matsumoto; Atsushi;
(Ashigarakami-gun, JP) |
Correspondence
Address: |
BUCHANAN, INGERSOLL & ROONEY PC
POST OFFICE BOX 1404
ALEXANDRIA
VA
22313-1404
US
|
Assignee: |
Terumo Kabushiki Kaisha
Tokyo
JP
|
Family ID: |
38005815 |
Appl. No.: |
11/594825 |
Filed: |
November 9, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60735177 |
Nov 10, 2005 |
|
|
|
Current U.S.
Class: |
606/185 |
Current CPC
Class: |
A61M 2005/1585 20130101;
A61M 5/3287 20130101; A61M 5/425 20130101; A61M 5/158 20130101 |
Class at
Publication: |
606/185 |
International
Class: |
A61B 17/34 20060101
A61B017/34 |
Foreign Application Data
Date |
Code |
Application Number |
May 31, 2006 |
JP |
2006-152318 |
Claims
1. In a puncture device puncturing a skin by a puncture needle, a
puncture device comprising a puncture needle moving means for
retaining said puncture needle to be movable and a skin deforming
means for deforming a skin, wherein the puncture needle is moved by
said puncture needle moving means and the skin deformed by said
skin deforming means is to be punctured.
2. The puncture device according to claim 1 wherein said puncture
device includes a fixing portion having a plane fixed to the skin
and a skin fixing plane equipped in said skin deforming means, and
said skin deforming means deforms the skin so as to form a step
portion between said skin fixing plane and the plane of said fixing
portion.
3. The puncture device according to claim 2, wherein said puncture
needle moving means moves said puncture needle approximately in
parallel with said skin fixing plane so as to puncture said step
portion.
4. The puncture device according to claim 2, wherein said puncture
needle moving means moves said puncture needle approximately in
parallel with the plane of said fixing portion so as to puncture
said step portion.
5. An administration device comprising: a puncture device having
one puncture needle puncturing a skin and making said puncture
needle to go into in parallel with respect to a predetermined layer
of said skin; and an injection device which is in communication
with said puncture needle and at the same time injects a substance
to a predetermined layer of said skin through said puncture needle,
wherein said substance is administered to a dermis within said skin
layers in a range of 0.1 psi to 500 psi with respect to
pressure.
6. The administration device according to claim 5, wherein said
substance is administered for a predetermined time when said
substance is administered with administration flow velocity by 100
.mu.l/minute.
7. The administration device according to claim 5, wherein said
substance is administered by administration flow velocity 1000 to
2000 .mu.l/minute when the pressure is in a range of 90 psi to 500
psi.
8. The administration device according to claim 5, wherein the
administration time is 130 seconds or less when said substance is
administered with administration flow velocity by 1000
.mu.l/minute.
9. The administration device according to claim 5, wherein the
administration time is 90 seconds or less when said substance is
administered with administration flow velocity by 2000
.mu.l/minute.
10. The administration device according to claim 5, wherein the
maximum pressure of said substance is 200 psi to 500 psi when the
administration flow velocity is made to be 1000 .mu.l to 2000
.mu.l/minute.
11. The administration device according to claim 5, wherein said
substance is administered for a predetermined time in a state in
which the maximum pressure of said substance is 460 psi.
12. The administration device according to claim 11, wherein said
predetermined time is 90 seconds or less.
13. The administration device according to claim 5 wherein said
puncture device comprises a puncture needle moving means for
retaining said puncture needle to be movable and a skin deforming
means for deforming said skin, wherein said puncture needle is
moved by said puncture needle moving means so as to puncture said
skin deformed by said skin deforming means.
14. The administration device according to claim 5, wherein said
puncture device makes said puncture needle to go into the skin at
least by 0.5 mm.
15. An administration device comprising: a puncture device having
one puncture needle puncturing a skin and making said puncture
needle to go into the skin at least by 0.5 mm; and an injection
device which is made to be in communication with said puncture
needle and at the same time injects a substance to a predetermined
layer of said skin through said puncture needle, wherein the
maximum pressure of the substance is 200 psi to 500 psi when the
administration flow velocity is made to be 1000 .mu.l to 2000
.mu.l/minute.
16. In a puncturing method puncturing a skin by a puncture needle,
a puncturing method using: a puncture needle moving means for
retaining said puncture needle to be movable; and a skin deforming
means for deforming said skin, wherein the puncture needle is moved
by said puncture needle moving means so as to puncture the skin
deformed by said skin deforming means.
17. The puncturing method according to claim 16, wherein the skin
is deformed by said skin deforming means such that a step portion
is to be formed between a skin fixing plane and a plane of a fixing
portion provided in said puncture device.
18. The puncturing method according to claim 17, wherein said
puncture needle is moved by said puncture needle moving means
approximately in parallel with said skin fixing plane so as to
puncture said step portion.
19. The puncturing method according to claim 17, wherein said
puncture needle is moved by said puncture needle moving means
approximately in parallel with the plane of said fixing portion so
as to puncture said step portion.
Description
TECHNICAL FIELD
[0001] The present invention relates to a puncture device and
relates to a puncture device which punctures from the surface of
skin and is used with respect to a predetermined region (for
example, dermis).
[0002] Also, the present invention relates to an administration
device and relates to an administration device which punctures from
the surface of skin and administers a substance with respect to a
predetermined region (for example, dermis).
[0003] Also, the present invention relates to a puncturing method
puncturing from the surface of skin to a predetermined region (for
example, dermis) by using a puncture device or the like.
BACKGROUND ART
[0004] It is known that the dermis has a high density of capillary
blood vessel when compared with an epidermis or a subcutis and also
a lymph vessel end exists therein, so that in particular, a medical
agent injected thereto directly is shifted to a blood vessel or a
lymph vessel and an absorption speed thereof being absorbed in the
body fluid is speedy. In particular, it is possible in the dermis
to make a medical agent using a macromolecular substance such as
hormone, antibody drug, cytokine and the like to be absorbed into
the blood efficiently. Also, it is known that the dermis is a place
of efficient immunity and it is possible to make a saving of
applied dose of vaccine or to strengthen sensitization of a weak
vaccine, so that it is possible to make a saving of immune cells to
be administered or to strengthen the effect thereof.
[0005] Also, it is known for adult human beings that the dermis
exists approximately in a certain amount of depth from the body
surface (surface of stratum corneum). In other words, this fact
means in case of injecting a medical agent into the dermis that it
is possible to use a puncture needle having the same length (depth)
with respect to these human beings.
[0006] Generally, the width of the dermis is around 1 mm to 4 mm
(average value is 1 mm to 2 mm) if the vertical direction with
respect to the body surface is made to be a reference and also, as
shown in FIG. 29, the dermis exists in the skin so as to be
sandwiched between an epidermis E which includes a stratum corneum
and has width of around 0.06 mm to 0.1 mm and a subcutis S.
[0007] Accordingly, it is difficult to insert an tip portion of the
puncture device, for example, a needlepoint of the puncture needle
accurately to the dermis which exists between the epidermis and the
subcutis, and if the needlepoint is inserted erroneously to the
subcutis or the like, there occurs a problem such that a medical
agent cannot be absorbed efficiently.
[0008] In recent years, for example, it is attempted that the
macromolecular medicine mentioned above is administered continually
or by one-shot into the dermis as a target, and in such a case, in
particular, the above-mentioned problem becomes conspicuous.
[0009] Here, a hypodermic injection device is known in which the
length of the puncture needle to be inserted into the body is
defined in order to inject a medical agent to the dermis in the
body (Patent Document 1). In addition, a medicinal solution
injection device is also known in which the depth (insertion depth)
of the puncture needle to be inserted into the skin is defined to
be a predetermined length in order to inject a medical agent into a
specific layer which exists in the skin and the puncture needle is
inserted into the skin from the vertical direction with respect to
the body surface (Patent Document 2). Also, a medicinal solution
injection device is known in which a medical agent or the like is
injectable with a predetermined pressure (Patent Document 3).
[0010] [Patent Document 1] Japanese Patent Laid-open No.
2001-137343
[0011] [Patent Document 2] Japanese Patent Laid-open No.
2005-87519
[0012] [Patent Document 3] US Patent Publication No.
2005/256499
DISCLOSURE OF THE INVENTION
[0013] However, there is employed in these devices a constitution
in which the puncture needle is inserted into the skin from the
vertical direction with respect to the body surface. In this case,
if it is attempted to puncture with the puncture needle, the whole
skin is sunk in elastically so as not to be punctured and also,
even if it is punctured, it sometimes happens that the needlepoint
cannot reach the dermis.
[0014] Also, when the puncture needle is inserted perpendicularly
with respect to the dermis, the depth (insertion depth) of the
puncture needle in the dermis becomes short and, for example, in
such a case where some kind of shock or the like is added from the
outside, there occurs a problem in which the puncture needle during
injecting a medical agent drops out from the dermis.
[0015] Further, in case of using these devices, the distance from
an insertion aperture of the puncture needle which is formed on the
surface of the dermis (boundary portion of epidermis and dermis) to
a medical agent releasing aperture which exists at the tip of the
puncture needle becomes short in the dermis. For that reason, there
is a fear that the medical agent injected to the dermis from the
medical agent releasing aperture is to leaks from the insertion
aperture to the outside of the dermis (epidermis). Then, the
medicinal solution becomes effective when a decided amount of the
solution is administered, so that a problem is to occur that
expected effect cannot be achieved if the amount of the leakage to
the outside of the body is large.
[0016] Also, generally, it is recommended to inject the medicinal
solution relatively at low flow velocity in order not to make the
medicinal solution leak from the skin. However, in a tissue having
a high density such as the dermis, there is a fear that the
medicinal solution may leak by not enduring the administration
pressure thereof even if injecting the medicinal solution
relatively at low flow velocity, so that it is necessary to inject
the medicinal solution further at lower flow velocity.
Consequently, there was a problem that the injection time of the
medicinal solution extends over a long time in order to inject the
medicinal solution into the tissue having a high density such as
the dermis without leakage.
[0017] In consideration of the above-mentioned problems, an object
of the present invention lies in providing a puncture device which
can stick a puncture needle certainly to a predetermined region of
a skin.
[0018] Also, in consideration of the above-mentioned problems, an
object of the present invention lies in providing an administration
device which can administer a predetermined amount of substance to
a predetermined layer of a skin, for example, to the dermis
continuously without leakage or can administer it thereto certainly
and relatively in a short time.
[0019] A puncture device relating to the present invention is a
device which punctures a skin by a puncture needle in which there
is provided with a puncture needle moving means for retaining
aforesaid puncture needle to be movable and a skin deforming means
for deforming a skin, characterized by being constituted such that
the puncture needle is moved by aforesaid puncture needle moving
means and the skin deformed by aforesaid skin deforming means is to
be punctured.
[0020] According to the puncture device relating to the present
invention, it is possible to reach a predetermined region certainly
by sticking a puncture needle to the skin. Also, it is possible to
inject a medical agent certainly into a predetermined region.
[0021] Also, an administration device relating to the present
invention is provided with a puncture device that has one puncture
needle puncturing a skin and makes aforesaid puncture needle to go
into in parallel with respect to a predetermined layer of aforesaid
skin; and an injection device which is in communication with
aforesaid puncture needle and at the same time injects a substance
to a predetermined layer of aforesaid skin through aforesaid
puncture needle, characterized in that aforesaid substance is
administered to a dermis within aforesaid skin layers in a range of
0.1 psi to 500 psi with respect to pressure.
[0022] According to the administration device relating to the
present invention, it is possible to administer a predetermined
amount of substance with respect to the skin without leakage.
BRIEF DESCRIPTION OF DRAWINGS
[0023] [FIG. 1] A perspective view showing a first exemplified
embodiment of a puncture device of the present invention;
[0024] [FIG. 2] A cross-section view by A-A line in FIG. 1;
[0025] [FIG. 3] Diagrams (cross-section views) for explaining usage
of the puncture device shown in FIG. 1;
[0026] [FIG. 4] Diagrams (cross-section views) for explaining usage
of the puncture device shown in FIG. 1;
[0027] [FIG. 5] A perspective view showing a second exemplified
embodiment of a puncture device of the present invention;
[0028] [FIG. 6] A cross-section view by A-A line in FIG. 5;
[0029] [FIG. 7] First diagrams (cross-section views) for explaining
usage of the puncture device shown in FIG. 5;
[0030] [FIG. 8] Second diagrams (cross-section views) for
explaining usage of the puncture device shown in FIG. 5;
[0031] [FIG. 9] A perspective view showing a third exemplified
embodiment of a puncture device of the present invention;
[0032] [FIG. 10] A cross-section view by A-A line in FIG. 9;
[0033] [FIG. 11] First diagrams (cross-section views) for
explaining usage of the puncture device shown in FIG. 9;
[0034] [FIG. 12] Second diagrams (cross-section views) for
explaining usage of the puncture device shown in FIG. 9;
[0035] [FIG. 13] A perspective view showing a fourth exemplified
embodiment of a puncture device of the present invention;
[0036] [FIG. 14] A cross-section view by A-A line in FIG. 13;
[0037] [FIG. 15] Diagrams (cross-section views) for explaining
usage of the puncture device shown in FIG. 13;
[0038] [FIG. 16] Diagrams (cross-section views) for explaining
usage of the puncture device shown in FIG. 13;
[0039] [FIG. 17] A perspective view showing a fifth exemplified
embodiment of a puncture device of the present invention;
[0040] [FIG. 18] A cross-section view by A-A line in FIG. 17;
[0041] [FIG. 19] Diagrams (cross-section views) for explaining
usage of the puncture device shown in FIG. 17;
[0042] [FIG. 20] Diagrams (cross-section views) for explaining
usage of the puncture device shown in FIG. 17;
[0043] [FIG. 21] A diagram showing a sixth exemplified embodiment
of a puncture device of the present invention and an exemplified
embodiment of an administration device of the present invention
which is a perspective view seen from the front side;
[0044] [FIG. 22] A right side elevational view (tip side of the
positioning portion is made to be front side) of the puncture
device shown in FIG. 21;
[0045] [FIG. 23] An exploded perspective view of the puncture
device shown in FIG. 21;
[0046] [FIG. 24] An enlarged view showing the puncture needle of
the puncture device shown in FIG. 21 by being enlarged;
[0047] [FIG. 25] An explanatory diagram indicating a state in which
a positioning portion and a depressing surface of the puncture
device shown in FIG. 21 are bonded to the body surface;
[0048] [FIG. 26] An explanatory diagram indicating a state in which
a fixing portion of the puncture device shown in FIG. 21 is turned
to the body surface side and the contact surface thereof is bonded
to the body surface;
[0049] [FIG. 27] An explanatory diagram indicating a state in which
a slide member of the puncture device shown in FIG. 21 is slided to
the positioning portion side;
[0050] [FIG. 28] An explanatory diagram indicating a state in which
the slide member is further slided from the state shown in FIG. 27
and the puncture needle is stuck to the dermis of the skin;
[0051] [FIG. 29] An explanatory diagram indicating a relation of
depressing surface height of the puncture device shown in FIG. 21
and mounting position of the puncture needle;
[0052] [FIG. 30] An explanatory diagram showing another embodiment
of a mounting position of an adhesion member relating to the
puncture device shown in FIG. 21;
[0053] [FIG. 31] A diagram indicating a measured result of blood
concentrations of a case in which insulin is administered to the
dermis by using the administration device of the present invention
and of a case in which insulin is administered into the
subcutaneous by using a conventional device, which is a diagram
showing a time curve of blood concentration;
[0054] [FIG. 32] A cross-section view showing a general skin
structure.
BEST MODE FOR CARRYING OUT THE INVENTION
[0055] A puncture device relating to an exemplified embodiment of
the present invention is a puncture device puncturing a skin by a
puncture needle and is provided with a puncture needle moving means
for retaining aforesaid puncture needle to be movable and a skin
deforming means for deforming the skin, wherein it is constituted
such that the puncture needle is moved by aforesaid puncture needle
moving means and punctures the skin deformed by aforesaid skin
deforming means. By employing this constitution, it is possible to
stick the puncture needle to the skin so as to be reached to a
predetermined region certainly.
[0056] The above-described puncture device relating to an
exemplified embodiment of the present invention includes a fixing
portion having a plane to be fixed on the skin and a skin fixing
plane equipped in aforesaid skin deforming means, wherein it is
constituted such that aforesaid skin deforming means deforms the
skin so as to form a step portion between aforesaid skin fixing
plane and the plane of aforesaid fixing portion.
[0057] It is constituted such that aforesaid puncture needle moving
means of the puncture device relating to an exemplified embodiment
of the present invention moves aforesaid puncture needle
approximately in parallel with respect to aforesaid skin fixing
plane and aforesaid step portion is to be punctured.
[0058] It is constituted such that aforesaid puncture needle moving
means of a puncture device relating to an exemplified embodiment of
the present invention moves aforesaid puncture needle approximately
in parallel with respect to the plane of aforesaid fixing portion
and aforesaid step portion is to be punctured.
[0059] An administration device relating to an exemplified
embodiment of the present invention is provided with a puncture
device that has one puncture needle puncturing a skin and makes
aforesaid puncture needle to go into in parallel with respect to a
predetermined layer of aforesaid skin; and an injection device
which is in communication with aforesaid puncture needle and at the
same time injects a substance to a predetermined layer of aforesaid
skin through aforesaid puncture needle, wherein it is constituted
such that aforesaid substance is administered to a dermis within
aforesaid skin layers in a range of 0.1 psi to 500 psi with respect
to pressure. By employing this constitution, it is possible to
administer a predetermined amount of substance with respect to the
skin without leakage.
[0060] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which aforesaid substance is administered by a
predetermined time when the aforesaid substance is administered by
an administration flow velocity of 100 .mu.l/minute.
[0061] An administration device relating to an exemplified
embodiment of the present invention is made to have a constitution
in which aforesaid substance is administered by administration flow
velocity 1000 to 2000 .mu.l/minute when the pressure is in a range
of 90 psi to 500 psi.
[0062] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which the administration time is 130 seconds or
less when aforesaid substance is administered with administration
flow velocity by 1000 .mu.l/minute.
[0063] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which the administration time is 90 seconds or less
when aforesaid substance is administered with administration flow
velocity by 2000 .mu.l/minute.
[0064] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which the maximum pressure of aforesaid substance
is 200 psi to 500 psi when the administration flow velocity is made
to be 1000 .mu.l to 2000 .mu.l/minute.
[0065] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which aforesaid substance is administered for a
predetermined time in a state in which the maximum pressure of
aforesaid substance is 460 psi.
[0066] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which aforesaid predetermined time is 90 seconds or
less.
[0067] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which a puncture device comprises a puncture needle
moving means for retaining aforesaid puncture needle to be movable
and a skin deforming means for deforming aforesaid skin, aforesaid
puncture needle is moved by aforesaid puncture needle moving means,
and aforesaid skin deformed by aforesaid skin deforming means is to
be punctured.
[0068] The above-described administration device relating to an
exemplified embodiment of the present invention is made to have a
constitution in which with respect to the puncture device,
aforesaid puncture needle is made to go into the skin at least by
0.5 mm.
[0069] An administration device relating to another exemplified
embodiment of the present invention is made to have a constitution
in which there is provided with a puncture device that has one
puncture needle puncturing a skin and makes said puncture needle to
go into the skin at least by 0.5 mm; and an injection device which
is made to be in communication with said puncture needle and at the
same time injects a substance to a predetermined layer of said skin
through said puncture needle, wherein the maximum pressure of the
substance is 200 psi to 500 psi when the administration flow
velocity is made to be 1000 .mu.l to 2000 .mu.l/minute. By
employing this constitution, it is possible to administer a
predetermined amount of substance with respect to the skin without
leakage.
[0070] A puncturing method relating to an exemplified embodiment of
the present invention is a method in which in order to stick the
puncture needle to a predetermined region of the skin certainly,
there are used a puncture needle moving means for retaining
aforesaid puncture needle to be movable; and a skin deforming means
for deforming aforesaid skin, wherein the puncture needle is moved
by aforesaid puncture needle moving means so as to puncture the
skin deformed by aforesaid skin deforming means. According to this
method, it is possible to stick the puncture needle to the skin so
as to be reached to a predetermined region certainly.
[0071] The aforesaid puncturing method relating to an exemplified
embodiment of the present invention is a method in which the skin
is deformed by aforesaid skin deforming means such that a step
portion is to be formed between a skin fixing plane and a plane of
a fixing portion provided in aforesaid puncture device.
[0072] The aforesaid puncturing method relating to an exemplified
embodiment of the present invention is a method in which aforesaid
puncture needle is moved by aforesaid puncture needle moving means
approximately in parallel with aforesaid skin fixing plane so as to
puncture aforesaid step portion.
[0073] The aforesaid puncturing method relating to an exemplified
embodiment of the present invention is a method in which aforesaid
puncture needle is moved by aforesaid puncture needle moving means
approximately in parallel with the plane of aforesaid fixing
portion so as to puncture aforesaid step portion.
[0074] Hereinafter, it will be explained with respect to
embodiments for practicing the puncture device of the present
invention with reference to the drawings, wherein it should be
noted that the present invention is not limited by the following
embodiments.
FIRST EXEMPLIFIED EMBODIMENT
[0075] First, it will be explained with respect to a first
exemplified embodiment of a puncture device of the present
invention.
[0076] FIG. 1 is a perspective view showing a first exemplified
embodiment of a puncture device of the present invention. FIG. 2 is
a diagram showing a cross-section view by A-A line in FIG. 1. Also,
FIG. 3 and FIG. 4 are diagrams (cross-section views) for explaining
usage of the puncture device shown in FIG. 1. It should be noted
that it will be explained hereinafter on an assumption that the
right side in FIG. 2 to FIG. 4 is made to be "rear end" and the
left side thereof is made to be "tip".
[0077] A puncture device 1 shown in FIG. 1 is provided with an
adhesive pad 2 which is a fixing portion, a skin deforming means 3
for deforming and uplifting a skin and a puncture needle moving
means 4 for retaining a puncture needle 411 to be movable.
[0078] The adhesive pad 2 is almost rounded and is formed so as to
have a shape in which facing concave portions are formed at
portions of the circumference thereof, so-called, a wing-like
shape.
[0079] It should be noted that the wing-like shape of the adhesive
pad 2 is formed such that the area of the side on which the
puncture needle moving means 4 is mounted becomes larger than the
area of the side on which the skin deforming means 3 is provided.
In this manner, by making the area of the adhesive pad 2 on the
side on which the puncture needle moving means 4 is mounted to be
larger, it is possible to increase stability with respect to a body
surface F and to carry out the movement of the puncture needle 411
by means of the puncture needle moving means 4 in a stable
state.
[0080] The adhesive pad 2 is formed with a hinge opening 21 for
mounting a hinge 5 which is the skin deforming means 3 on the body
surface F. Also, the adhesive pad 2 is formed with a puncture
needle opening 22 which is positioned adjacently with the hinge
opening 21 so as to be along the moving direction of the puncture
needle 411.
[0081] The puncture needle opening 22 is formed so as to be opened
from a base end portion of a turning piece 52 of the hinge 5 to be
described hereinafter until a tip portion of a support member 43.
Also, the width of the puncture needle opening 22 is formed so as
to be approximately identical with the width of the turning piece
52. In this manner, a gap is formed between the base end side of
the turning piece 52 and the tip portion of the support member 43,
so that it becomes easy to uplift the skin by means of the turning
piece 52. Also, it becomes easy owing to the gap to grasp the edge
portion of the turning piece 52, so that it is possible to turn the
turning piece 52 easily.
[0082] As shown in FIG. 2, there is formed on the body surface F
side of the adhesive pad 2 with a plane 2a for fixing the adhesive
pad 2 on the body surface F (skin) by being appressed thereto. This
plane 2a is provided with an adhesion means and for the adhesion
means, it is allowed to apply an adhesive agent on the plane 2a in
the form of laminae or it is also allowed to attempt gluing an
adhesive film constituted by a two-sided tape thereon.
[0083] The plane 2a of the adhesive pad 2 is fixed on the body
surface F by the adhesive agent. It should be noted that there are
arranged, on the lower side of the body surface F, a stratum
corneum SC, an epidermis E including the stratum corneum SC, a
dermis D and a subcutis S in the form of laminae.
[0084] Then, as being described hereinafter, the puncture needle
411 is moved to the tip direction along the plane 2a of the
adhesive pad 2 by the puncture needle moving means 4 and the skin
uplifted by the skin deforming means 3 is to be punctured.
[0085] The adhesive pad 2 is constituted, for example, by soft
polymer such as flexible polyurethane or the like.
[0086] The skin deforming means 3 is constituted by a tabular hinge
5 composed of a fixed piece 51 and a turning piece 52 which are a
pair of fixed pieces, and a turning axis 53 interlinking the fixed
piece 51 and the turning piece 52 which is provided between the
fixed piece 51 and the turning piece 52. Also, the turning piece 52
is supported by the turning axis 53 so as to turn in the vertical
direction with respect to the moving direction of the puncture
needle 411.
[0087] Also, there is formed on the body surface F side of the
turning piece 52 with a skin fixing plane 52a for fixing the
skin.
[0088] The hinge 5 is mounted on the body surface F through the
hinge opening 21 formed on the adhesive pad 2. Also, there is
provided on the body surface F side of the fixed piece 51 and
turning piece 52 with an adhesive film 54 as the bonding means and
as shown in FIG. 2, the hinge 5 is fixed on the body surface F by
this adhesive film 54. For the bonding means, for example, an
adhesive film of a two-sided tape or the like is used.
[0089] The hinge 5 is constituted by a metal material, but it is
not necessary to be limited by a metal material in particular if
only it has stiffness of a high degree such that the height of the
skin to be uplifted can be defined accurately. In this manner, by
constituting the hinge 5 with a material having higher hardness
than that of the material of the adhesive pad 2, it is possible to
lift up the skin certainly in the vertical direction with respect
to the body surface F.
[0090] In addition, it is also allowed for the hinge 5 to have such
a constitution in which the area of the fixed piece 51 becomes
larger than the area of the turning piece 52. By constituting in
this manner, it is possible to uplift the skin by the turning piece
52 while the fixed piece 51 is fixed on the body surface F
certainly and the stable state is maintained.
[0091] The puncture needle moving means 4 is constituted by an
injector 41 having the puncture needle 411, a mounting member 42
for mounting and fixing the injector 41 and a support member 43 for
supporting the mounting member 42 to be movable.
[0092] Also, the support member 43 of the puncture needle moving
means 4 is constituted integrally with the fixed piece 51 of the
hinge 5 by a frame material (not shown).
[0093] The injector 41 is provided with the puncture needle 411, a
fixed outer cylinder 412, an internal outer cylinder 413 slidable
in the fixed outer cylinder 412, a gasket 414 slidable in the
internal outer cylinder 413 and a plunger 415 which moving-operates
the gasket 414.
[0094] The fixed outer cylinder 412 has a cylindrical shape with
bottom and is mounted and fixed on the mounting member 42 by means
of adhesive agent or the like. Also, there is formed in the
vicinity of the central portion of the bottom portion of the fixed
outer cylinder 412 with a puncture needle opening 412a for carrying
out insertion of the puncture needle 411.
[0095] The internal outer cylinder 413 has a cylindrical shape with
bottom. Also, the puncture needle 411 is firmly fixed by adhesion
in the vicinity of the central portion of the bottom portion.
[0096] The needlepoint 411a of the puncture needle 411 is provided
so as not to project from the puncture needle opening 412a which is
provided at the fixed outer cylinder 412. More specifically, the
puncture needle 411 is located with respect to the fixed outer
cylinder 412 such that the needlepoint 411a thereof is to be
positioned on the inner side as compared with the bottom face of
the fixed outer cylinder 412 at which the puncture needle opening
412a is provided and also in the vicinity of the puncture needle
opening 412a.
[0097] By constituting in this manner, it is possible to protect
the needlepoint 411a of the puncture needle 411. Also, it is
possible to reduce awful feeling of a user, because the needlepoint
411a becomes hard to be seen.
[0098] The outer diameter of the puncture needle 411 is a little
bit different depending on the use application or the like of the
puncture device 1, but it is preferable to be around 0.05 mm to 2.0
mm and in particular, it is preferable to be around 0.1 mm to 11.0
mm.
[0099] For the constituent material of the puncture needle 411,
there can be cited, for example, a metal material such as stainless
steel, aluminum or aluminum alloy, titanium or titanium alloy or
the like. Also, the puncture member 411 is manufactured, for
example, by plastic working.
[0100] It is possible for the internal outer cylinder 413 to slide
in the fixed outer cylinder 412 in a longitudinal direction of the
internal outer cylinder 413 by means of the operation of the
plunger 415 and when the internal outer cylinder 413 slides, the
puncture needle 411 firmly fixed to the internal outer cylinder 413
is taken in and out with respect to the fixed outer cylinder 412
through the puncture needle opening 412a.
[0101] For the constituent material of the fixed outer cylinder 412
and the internal outer cylinder 413, there can be cited various
kinds of resins such, for example, as polyvinylchloride,
polyethylene, polypropylene and the like. It should be noted that
the constituent material of the fixed outer cylinder 412 and the
internal outer cylinder 413 is desirable to be substantially
transparent in order to ensure visibility of the inside.
[0102] There is housed, in the internal outer cylinder 413, the
gasket 414 constituted by an elastic material.
[0103] For the constituent material of the gasket 414, although it
is not limited in particular, there can be cited, for example,
various kinds of rubber materials such as natural rubber and
silicone rubber, various kinds of thermoplastic elastomers of
polyurethane series, styrene series and the like or elastic
materials of mixtures thereof and the like.
[0104] In the space surrounded by the gasket 414 and internal outer
cylinder 413, a liquid room 417 is formed and in this liquid room
417, liquid is contained liquid-tightly beforehand.
[0105] There can be cited for the liquid, for example, remedy for
injection or medicinal solution using a macromolecular substance
such as hormone, antibody drug, cytokine, vaccine or the like.
[0106] There is interlinked to the gasket 414 the plunger 415 which
moving-operate the gasket 414 in the internal outer cylinder 413 in
a longitudinal direction.
[0107] A plate-like flange 416 is formed integrally at the rear end
of the plunger 415. The plunger 415 is operated by depressing this
flange 416 with a finger or the like.
[0108] The mounting member 42 is constituted so as to include an
upper surface portion 42a for mounting the injector 41. At the
lower portion in a longitudinal direction of the mounting member,
there is formed, by being projected toward the adhesive pad 2, a
U-shaped engagement portion 422 to be movable and for being engaged
with the support member 43.
[0109] On the mounting member 42, there is provided with an
inclined portion 42c in a state in which the upper surface portion
42a has a predetermined angle 31 with respect to the moving
direction of the puncture needle 411. Also, the angle of gradient
.theta.1 of this inclined portion is set so as to be identical with
the turning angle .theta.2 of the turning piece 52 of the hinge 5
shown in FIG. 3B.
[0110] The support member 43 is constituted by a rectangular
plate-like body having an upper surface portion 43a which contacts
slidably with a mounting member 42. At the edge portion in a
longitudinal direction of the plate-like body, there is formed, by
being projected to the horizontal direction with respect to the
adhesive pad 2, an engagement convex portion 431 which has such a
shape to coincide with the U-shaped engagement portion 421 which is
formed on the mounting member 42.
[0111] On the plane on the opposite side of the upper surface
portion 43a of the support member 43, there is formed a lower
surface portion 43b for being fixed with the adhesive pad 2
adhesively. As shown in FIG. 2, the lower surface portion 43b is
fixed on the adhesive pad 2 by adhesive agent or the like.
[0112] There can be cited for the constituent material of the
mounting member 42 and the support member 43 various kinds of
resins such as polyethylene, polypropylene or the like and the
mounting member 42 and the support member 43 are manufactured by a
forming process inpouring these resins into a die which has a
predetermined shape or the like.
[0113] It should be noted as the puncture needle moving means 4
that it is allowed to employ such a constitution wherein an
injector having a constitution in which a puncture needle and a
syringe are formed as one body configuration is fixed and retained
on the mounting member 42. In this case, the length of the puncture
needle 411 is adjusted such that the needlepoint 411a of the
puncture needle 411 can puncture the skin uplifted by the skin
deforming means 3 when the mounting member 42 is moved so as to
most approach to the skin deforming means 3.
[0114] Next, it will be explained by using FIG. 3 and FIG. 4 with
respect to usage (operation) of the puncture device 1 of this
exemplified embodiment.
[0115] First, the adhesive pad 2 is mounted on a predetermined
position of the body surface F.
[0116] At that time, the plane 2a of the adhesive pad 2 is bonded
and fixed on the body surface F by means of an adhesive film
provided on the body surface F side of the adhesive pad 2.
[0117] At the same time, also the hinge 5 which is located so as to
mesh with the hinge opening 21 formed on the adhesive pad 2 is
mounted on the body surface F. At that time, the hinge 5 is bonded
and fixed on the body surface F by means of the adhesive film 54
provided on the body surface F side of the fixed piece 51 and
turning piece 52 of the hinge 5.
[0118] Next, by grasping the turning piece 52 of the hinge 5, the
turning piece 52 is turned to the direction of the arrow shown in
FIG. 3A centering around the turning axis 53.
[0119] When the turning piece 52 is turned upward, the skin bonded
to the adhesive film 54 which is provided on the body surface F
side of the turning piece 52 is pulled out upward with respect to
the body surface F together with the turning of the turning piece
52. More specifically, the epidermis E including the stratum
corneum SC, the dermis D and the subcutis S are pulled out upward
respectively and the skin is uplifted to the vertical direction
with respect to the body surface F. In this case, the dermis D
pulled out by the turning piece 52 is uplifted in a state parallel
with the turned turning piece 52.
[0120] Also, the turning axis 53 of the hinge 5 is arranged so as
to be in the vertical direction with respect to the moving
direction of the puncture needle 411, so that the skin is uplifted
in a state in which the region (puncture region P) of the skin to
be punctured is to be faced to the needlepoint 411a of the puncture
needle 411.
[0121] More specifically, depending on a fact that the skin is
deformed and uplifted, the position of the plane 2a of the adhesive
pad 2=which is the fixing portion and the position of the skin
fixing plane 52a of the turning piece 52 become different in the
height direction, a step portion is formed there-between and a
puncture region P is formed on the step portion thereof. Here, the
step means difference of the height which occurs between the plane
2a and the skin fixing plane 52a.
[0122] The turning of the turning piece 52 stops when it reaches a
turning angle .theta.2 which was set beforehand. The turning angle
.theta.2 of the turning axis 53 is set to be an angle, as shown in
FIG. 3B, in which at least the dermis D is to be projected upward
beyond the body surface F.
[0123] Next, the mounting member 42 on which the injector 41 is
fixedly retained is slided to the tip direction. More specifically,
the bottom face of the fixed outer cylinder 412 and the puncture
region P are made to be adjacent and the needlepoint 411a of the
puncture needle 411 is made to approach to the puncture region
P.
[0124] Next, the plunger 415 is operated by depressing the flange
416 with a finger or the like and the internal outer cylinder 413
is moved to the tip direction while it is slided together with the
fixed outer cylinder 412. Thereby, the puncture needle 411 firmly
fixed to the internal outer cylinder 413 is inserted into the
puncture region P from the puncture needle opening 412a and as
shown in FIG. 3C, the needlepoint 411a of the puncture needle 411
is punctured into the dermis D by bypassing the epidermis E
including the stratum corneum SC.
[0125] In this exemplified embodiment, the upper surface portion
42a of the mounting member 42 on which the injector 41 is fixedly
retained is provided with the angle of gradient .theta.1 which
becomes identical with the turning angle .theta.2 of the turning
piece 52 of the hinge 5, so that the needlepoint 411a of the
puncture needle 411 is stuck into the step portion (puncture region
P) in a state parallel with the skin fixing plane 52a of the
turning piece 52. More specifically, it is possible to insert the
puncture needle 411 into the dermis D so as to become parallel with
the dermis D which was uplifted in parallel with the turning piece
52.
[0126] At that time, the puncture needle 411 is stuck by a distance
of 0.3 mm to 30.0 mm and preferably of 3.0 mm to 8.0 mm with
respect to the skin and it is possible to be inserted by a distance
of 2.0 mm to 8.0 mm with respect to the dermis D.
[0127] The plunger 415 is operated by further depressing the flange
416 with a finger or the like from that state and the gasket 414 is
moved to the tip direction while sliding it together with the
internal outer cylinder 413. Thereby, as shown in FIG. 4A, a
medical agent 50 contained in the liquid room 417 is injected from
the needlepoint 411a of the puncture needle 411 to the dermis
D.
[0128] After the medical agent is injected into the dermis D, the
plunger 415 is operated by pulling the flange 416 with a finger or
the like, the gasket 414 is moved to the rear end direction and the
puncture needle 411 is pulled out from the puncture region P.
[0129] Further, the plunger 415 is moved to the rear end direction
and as shown in FIG. 4B, the puncture needle 411 is housed in the
fixed outer cylinder 412 from the puncture needle opening 421a.
[0130] Next, in this state, the mounting member 42 on which the
injector 41 is fixedly retained is slided to the rear end direction
so as to obtain a state of FIG. 4C, and finally, the adhesion of
the adhesive pad 2 and the hinge 5 with respect to the body surface
F is released and the puncture device 1 is exfoliated from the body
surface F.
[0131] In this manner, according to the puncture device 1 of this
exemplified embodiment, the puncture operation is carried out in a
state in which the skin is uplifted by the hinge 5, so that it is
possible to stick the puncture needle 411 certainly into the skin
(dermis D) and it is possible to inject the medicinal solution
certainly into the dermis D in of the skin.
[0132] Also, the puncture needle 411 is stuck so as to become
approximately a parallel state with respect to the turning piece
52, so that the insertion depth of the puncture needle 411 in the
inside of the dermis D becomes long and even in a case in which an
impact or the like is added from the outside, the puncture needle
411 during injecting the medical agent can be prevented from
dropping out from the dermis D.
[0133] Also, the distance from the insertion aperture of the
puncture needle 411, which is formed at a boundary portion between
the epidermis E and the dermis D to the medical agent releasing
aperture which exists at the needlepoint 411a becomes long, so that
the medical agent once injected into the dermis D from the medical
agent releasing aperture can be prevented from leaking from the
insertion aperture to the epidermis E by being flown back
[backward].
[0134] In addition, it is also possible for the puncture device of
this exemplified embodiment to be used in a field of implanting a
catheter other than an object in which, as being described above, a
medical agent is injected by one-shot. In this case, the catheter
is retained with the puncture needle and by leaving the catheter in
the skin and taking out only the puncture needle, the catheter is
implanted inside the skin. In this manner, by implanting a hollow
catheter which has an opening at the implanted portion, it is
possible to carry out continuous administration of a medical agent
or sampling of the body fluid component. In addition, by implanting
a catheter which has a sensor in the implanted portion, it is also
possible to carry out measurement of the body component.
[0135] In addition, this exemplified embodiment was explained by
using exemplified examples in which the puncture needle is always
stuck to the dermis D, but it is possible to use the puncture
device of the present invention also in case of sticking to a
intracutaneous area, a subcutis or further a muscle other than the
dermis.
[0136] It should be noted that the puncture device of this
exemplified embodiment is not limited by the above-mentioned each
exemplified embodiment and besides that, it goes without saying
that various modifications or changes can be employed for the
materials, the constitutions or the like in the region without
departing from the configuration of the present invention.
SECOND EXEMPLIFIED EMBODIMENT
[0137] Next, it will be explained with respect to a second
exemplified embodiment of a puncture device of the present
invention.
[0138] FIG. 5 is a perspective view showing a second exemplified
embodiment of a puncture device of the present invention. FIG. 6 is
a cross-section view by A-A line in FIG. 5. Also, FIG. 7A to 7C and
FIG. 8A to BC are diagrams (cross-section views) for explaining
usage of the puncture device shown in FIG. 5. It should be noted
hereinafter that it will be explained by assuming the right side of
FIG. 6 to FIG. 8 to be "rear end" and the left side thereof to be
"tip".
[0139] As shown in FIG. 5 and FIG. 6, a puncture device 1 showing a
second exemplified embodiment of the puncture device of the present
invention is constituted by being provided with an adhesive pad 2
which is the fixing portion, a skin deforming means 3 for deforming
and uplifting the skin, a puncture needle moving means 4 for
retaining a puncture needle 411 to be movable and the like.
[0140] The adhesive pad 2 is made to be a plate body having such a
shape in which two elliptical plate bodies of different sizes are
formed continuously in the lateral direction and, so-called, a
wing-like shape is formed.
[0141] On the upper surface of the adhesive pad 2, the skin
deforming means 3 is arranged on the small ellipse side and the
puncture needle moving means 4 is arranged on the large ellipse
side thereof. In this manner, by constituting the area of the side
on which the puncture needle moving means 4 is arranged to be
large, it is possible to increase stability with respect to the
body surface F and to carry out the movement of the puncture needle
411 by means of the puncture needle moving means 4 in a stable
state.
[0142] There is provided at a position corresponding to the skin
deforming means 3 of the adhesive pad 2 with an opening window 21a
for contacting a skin bonding member 33 to be described hereinafter
of the skin deforming means 3 to the body surface F.
[0143] The lower surface of the adhesive pad 2 is made to be a
plane 2a for fixing the adhesive pad 2 by being appressed to the
body surface F. An adhesion means is provided on this plane 2a and
as the adhesion means, it is allowed to apply an adhesive agent on
the plane 2a in the form of laminae or it is also allowed to glue a
adhesive film of a two-sided tape thereon. It should be noted that
a bonding means is not provided on the plane 2a of a position which
corresponds to downside of a support board 31. This is because it
becomes easy for the skin to be uplifted.
[0144] As shown in FIG. 6, the plane 2a of the adhesive pad 2 is
fixed on the body surface F by means of an adhesive agent. It
should be noted that there are arranged, on the lower side of the
body surface F, a stratum corneum SC, an epidermis E including the
stratum corneum SC, a dermis D and a subcutis S in the form of
laminae.
[0145] As the constituent material of such an adhesive pad 2, there
can be cited, for example, a soft polymer of flexible polyurethane
or the like.
[0146] The skin deforming means 3 is constituted by being provided
with the support board 31 fixed on the upper surface of the
adhesive pad 2, a skin bonding member 33 facing to the support
board 31 and a plurality of coil springs 32 or the like which are
intervened between the support board 31 and the skin bonding member
33 and are shown as one embodiment of a biasing member biasing the
skin bonding member 33.
[0147] The support board 31 of the skin deforming means 3 forms
approximately a quadrangular frame body and an opening portion 31a
thereof is faced to the opening window 21a of the adhesive pad 2.
On one side of the support board 31, there is provided on the upper
surface thereof with a side surface piece 311 which projects upward
and continuously. This side surface piece 311 is made to be
continuous with a support member 43 to be described hereinafter of
the puncture needle moving means 4.
[0148] The skin bonding member 33 is constituted by a main body
plate 331 forming approximately a quadrangular plate body and an
adhesion protrusion portion 332 which is inserted into the opening
portion 31a of the support board 31 and the opening window 21a of
the adhesive pad 2. The adhesion protrusion portion 322 of the skin
bonding member 33 projects on the lower surface of the main body
plate 331 continuously and approximately perpendicularly and has an
adhesion surface 332a as a skin fixing plane which is a plane for
being fixed on the body surface F.
[0149] The adhesion surface 332a of the adhesion protrusion portion
332 is provided with an adhesive film 34 showing one embodiment of
the adhesion means and by means of this adhesive film 34, the
adhesion surface 332a of the skin bonding member 33 is bonded on
the body surface F. For the adhesion means, for example, an
adhesive film of a two-sided tape or the like is used.
[0150] The plurality of coil springs 32 are provided by four pieces
according to this exemplified embodiment (three pieces are shown in
FIG. 5) and are arranged so as to connect four corners of the
support board 31 and four corners of the skin bonding member 33
respectively. More specifically, the coil springs 32 are set to be
all the same length, and one terminals thereof are fixed on the
upper surface of the support board 31 and the other terminals
thereof are fixed on the lower surface of the main body plate 331
of the skin bonding member 33, respectively. Thereby, it is
constituted so as to obtain a state in which the four coil springs
32 support the skin bonding member 33 at upper portion of the
support board 31.
[0151] Also, the coil springs 32 are made to be so-called
compression coil springs which receive compressive loads in the
direction of the center axis of the coil. For that reason, a state
can be obtained in which owing to these of coil springs 32, the
skin bonding member 33 is biased so as to be apart from the upper
surface of the support board 31 approximately in the vertical
direction.
[0152] In this exemplified embodiment, a constitution is employed
in which the coil springs 32 are provided by four pieces, but the
number of the coil springs 32 is not limited by four and it may be
three or less and also, it may be five or more. Also, a
constitution is employed in this exemplified embodiment in which
compression coil springs are used for the biasing member, but it is
not limited by this constitution with respect to the biasing member
relating to the present invention and it is possible to apply, for
example, a plate spring, an extension spring, a rubber-like elastic
body or the like.
[0153] In order to apply the extension spring to the skin deforming
means relating to the present invention, it is possible to cite,
for example, a constitution in which a leg portion for arranging
the support board 31 at the upper portion of the adhesive pad 2 is
provided, the extension spring is fixed on the lower surface of the
support board so as to be hung therefrom and at the same time the
other terminal of the extension spring is supported by being fixed
to the skin bonding member.
[0154] The puncture needle moving means 4 is constituted by an
injector 41 mounted with a puncture needle 411, a mounting member
42 for mounting and fixing the injector 41, and a support member 43
for supporting the mounting member 42 to be movable.
[0155] The injector 41 is provided with the puncture needle 411, a
fixed outer cylinder 412, an internal outer cylinder 413 slidable
in the fixed outer cylinder 412, a gasket 414 slidable in the
internal outer cylinder 413, and a plunger 415 moving-operating the
gasket 414.
[0156] The fixed outer cylinder 412 has a cylindrical shape with
bottom and is mounted and fixed on the mounting member 42 by means
of adhesive agent or the like. Also, there is formed in the
vicinity of the central portion of the bottom portion of the fixed
outer cylinder 412 with a puncture needle opening 412a for carrying
out insertion of the puncture needle 411.
[0157] The internal outer cylinder 413 has a cylindrical shape with
bottom. Also, the puncture needle 411 is mounted in the vicinity of
the central portion of bottom portion.
[0158] The needlepoint 411a of the puncture needle 411 is provided
so as not to project from the puncture needle opening 412a provided
a the fixed outer cylinder 412. More specifically, the puncture
needle 411 is located with respect to the fixed outer cylinder 412
such that the needlepoint 411a thereof is positioned on the inner
side as compared with the bottom face of the fixed outer cylinder
412 on which the puncture needle opening 412a is provided and also
in the vicinity of the puncture needle opening 412a.
[0159] By constituting in this manner, the needlepoint 411a of the
puncture needle 411 is protected. For that reason, it is possible
to prevent a finger or the like from touching the needlepoint 411a
of the puncture needle 411 or to prevent the puncture needle 411
from puncturing the finger or the like accidentally, and it is
possible to maintain the puncture needle 4 in a clean state. Also,
it never happens that the puncture needle 411 directly receives an
impact from the outside and it is possible to prevent the puncture
needle 411 from being deformed by the impact.
[0160] The outer diameter of the puncture needle 411 is a little
bit different depending on the use application or the like of the
puncture device 1, but it is preferable to select it as around 0.05
to 2 mm and in particular, preferable to select it as around 0.1 to
1.5 mm.
[0161] There can be cited, for the constituent material of the
puncture needle 411, metal materials such as, for example,
stainless steel, aluminum or aluminum alloy, titanium or titanium
alloy and the like. Also, the puncture needle 411 is manufactured,
for example, by plastic working.
[0162] It is possible for the internal outer cylinder 413 to slide
in the fixed outer cylinder 412 in a longitudinal direction of the
internal outer cylinder 413 by means of the operation of the
plunger 415 and when the internal outer cylinder 413 slides, the
puncture needle 411 firmly fixed to the internal outer cylinder 413
is taken in and out with respect to the fixed outer cylinder 412
through the puncture needle opening 412a.
[0163] For the constituent material of the fixed outer cylinder 412
and the internal outer cylinder 413, there can be cited various
kinds of resins such, for example, as polyvinylchloride,
polyethylene, polypropylene and the like. It should be noted that
the constituent material of the fixed outer cylinder 412 and the
internal outer cylinder 413 is desirable to be substantially
transparent in order to ensure visibility of the inside.
[0164] There is housed, in the internal outer cylinder 413, the
gasket 414 constituted by an elastic material.
[0165] For the constituent material of the gasket 414, although it
is not limited in particular, there can be cited, for example,
various kinds of rubber materials such as natural rubber and
silicone rubber, various kinds of thermoplastic elastomers of
polyurethane series, styrene series and the like or elastic
materials of mixtures thereof and the like.
[0166] In the space surrounded by the gasket 414 and internal outer
cylinder 413, a liquid room 417 is formed and in this liquid room
417, liquid is contained liquid-tightly beforehand.
[0167] There can be cited for the liquid, for example, remedy for
injection or medicinal solution using a macromolecular substance
such as hormone, antibody drug, cytokine, vaccine or the like.
[0168] There is interlinked to the gasket 414 the plunger 415 which
moving-operate the gasket 414 in the internal outer cylinder 413 in
a longitudinal direction.
[0169] A plate-like flange 416 is formed integrally at the rear end
of the plunger 415. The plunger 415 is operated by depressing this
flange 416 with a finger or the like.
[0170] The mounting member 42 is formed by a rectangular plate body
and there are provided on both the side surfaces of the long side
with engagement portions 421, 421. These engagement portions 421,
421 are slidably engaged with engagement convex portions 431, 431
to be described hereinafter of the support member 43. Then, a fixed
outer cylinder 412 of the injector 41 is fixed to an upper surface
portion 42a of the mounting member 42.
[0171] The support member 43 is formed by a rectangular plate body
which is set to be thicker than the mounting member 42 and an edge
portion on the tip side thereof is made to be continuous with the
side surface piece 311 of the support board 31. Thereby, the skin
deforming means 3 and the puncture needle moving means 4 are
constituted integrally. An firmly-fixing means of an adhesive agent
or the like is mounted on a lower surface portion 43b of the
support member 43 and as shown in FIG. 6, it is bonded and fixed on
the upper surface of the adhesive pad 2.
[0172] There are provided on both the side surfaces of the long
sides of the support member 43 with engagement convex portions 431,
431. Then, owing to a mechanism that the engagement portions 421,
421 of the mounting member 42 are engaged slidably with these
engagement convex portions 431, 431, the mounting member 42 is
supported by the support member 43 to be movable.
[0173] The upper surface portion 43a of the support member 43 is
made to be parallel with respect to the plane of the adhesive pad 2
and the adhesion surface 332a of the skin bonding member 33. For
that reason, the mounting member 42 moved along the upper surface
portion 43a of the support member 43 is made to move in parallel
with respect to the plane of the adhesive pad 2 and the adhesion
surface 332a of the skin bonding member 33. Also, an axis center
line of the puncture needle 411 mounted on the injector 41 is made
to coincide with the moving direction of the mounting member
42.
[0174] It is possible for the constituent material of the mounting
member 42 and the support member 43 of the puncture needle moving
means 4, and of the support board 31 and the skin bonding member 33
of the skin deforming means 3 to cite, for example, various kinds
of synthetic resins having appropriate strength such as acrylic
resin, ABS resin and the like, but it is not limited by this
material and it is also possible to use a metal such as aluminum
alloy or the like.
[0175] It should be noted as the puncture needle moving means 4
that it is allowed to employ such a constitution wherein an
injector having a constitution in which a puncture needle and a
syringe are formed as one body configuration is fixed and retained
on the mounting member 42. In this case, the length of the puncture
needle 411 is adjusted such that the needlepoint 411a of the
puncture needle 411 can puncture the skin uplifted by the skin
deforming means 3 when the mounting member 42 is moved so as to
most approach to the skin deforming means 3.
[0176] Also, a constitution is employed in this exemplified
embodiment in which the injector 41 is provided in the puncture
needle moving means 4 and the puncture needle 411 is mounted on the
injector thereof, but it is not limited by this constitution and it
is allowed to employ, for example, a constitution in which a tube
for communicating with the side opposite to the needlepoint 411a of
the puncture needle 411 is provided and the other terminal of that
tube is made to communicate with an infusion device such as a
liquid transmission pump or the like.
[0177] Next, it will be explained with respect to the usage
(operation) of the puncture device 1 of the second exemplified
embodiment.
[0178] First, as shown in FIG. 7A, the puncture device 1 is mounted
on a predetermined position of the body surface F. At that time,
the puncture device 1 is bonded and fixed on the body surface F by
means of an adhesive film provided on the plane 2a which is the
lower surface of the adhesive pad 2.
[0179] Next, as shown in FIG. 7B, the skin bonding member 33 is
depressed downward by a finger so as to compress the four coil
springs 32. Thereby, the adhesion protrusion portion 322 of the
skin bonding member 33 is inserted into the opening portion 31a of
the support board 31 and the opening window 21a of the adhesive pad
2, and the adhesion surface 322a of the adhesion protrusion portion
322 is bonded to the body surface F by the adhesive film 34. It
should be noted that it is allowed for the puncture device of the
present invention to employ a constitution in which the coil
springs 32 are latched in a state of being compressed and the skin
bonding member 33 is inserted into the opening window 21a
beforehand. In this case, the skin bonding member 33 is bonded to
the body surface concurrently when the puncture device 1 is bonded
and fixed on a predetermined position of the body surface F.
[0180] Next, as shown in FIG. 7C, the finger depressing the skin
bonding member 33 is released. Thereby, the skin bonding member 33
is biased by the spring force of the four coil springs 32 and is
moved upward.
[0181] Concurrently with this, the skin bonded to the adhesion
surface 322a as the skin fixing plane of the skin bonding member 33
is pulled upward. More specifically, the epidermis E including the
stratum corneum SC, the dermis D and the subcutis S are pulled
upward respectively and the skin is uplifted to the vertical
direction with respect to the body surface F. At that time, the
dermis D of the uplifted skin or the like is made to be in a state
approximately parallel with the adhesion surface 322a of the skin
bonding member 33.
[0182] More specifically, depending on a fact that the skin is
deformed and uplifted, the position of the plane 2a of the adhesive
pad 2=which is the fixing portion and the position of the adhesion
surface 322a as the skin fixing plane become different in the
height direction, a step portion is formed there-between and the
puncture needle 411 is stuck into the step portion thereof.
[0183] Further, the four coil springs 32 are set to be a
predetermined length, so that it becomes a state in which the
height of the dermis D of the skin pulled up by the skin bonding
member 33 and the height by which the puncture needle 411 of the
puncture needle moving means 4 is located will coincide with each
other.
[0184] Next, the mounting member 42 on which the injector 41 is
fixedly retained is slided to the tip direction. More specifically,
the bottom face of the fixed outer cylinder 412 and the side
surface of the uplifted skin are made to be adjacent and the
needlepoint 411a of the puncture needle 411 is made to approach to
the side surface of the uplifted skin.
[0185] Next, the plunger 415 is operated by depressing the flange
416 with a finger or the like and the internal outer cylinder 413
is moved to the tip direction while being slided in the fixed outer
cylinder 412.
[0186] Thereby, the puncture needle 411 firmly fixed on the
internal outer cylinder 413 is inserted into a puncture region
(step portion) from the puncture needle opening 412a and as shown
in FIG. 8A, the needlepoint 411a of the puncture needle 411 is
stuck in parallel with respect to the dermis D by bypassing the
epidermis E including the stratum corneum SC.
[0187] The plunger 415 is operated by further depressing the flange
416 with a finger or the like from that state and the gasket 414 is
moved to the tip direction while sliding it in the internal outer
cylinder 413. Thereby, as shown in FIG. 8B, the liquid contained in
the liquid room 417 is injected from the needlepoint 411a of the
puncture needle 411 to the dermis D.
[0188] After the liquid is injected into the dermis D and
thereafter, the mounting member 42 is moved to the rear end
direction and the puncture needle 411 is pulled out from the
uplifted skin.
[0189] Further, the plunger 415 is moved to the rear end direction
and the puncture needle 411 is housed in the fixed outer cylinder
412 through the puncture needle opening 412a.
[0190] Next, in this state, the mounting member 42 on which the
injector 41 is fixedly retained is slided to the rear end direction
so as to obtain a state of FIG. 8C, and finally, the adhesion of
the adhesive pad 2 and the skin bonding member 33 with respect to
the body surface F is released and the puncture device 1 is
exfoliated from the body surface F.
THIRD EXEMPLIFIED EMBODIMENT
[0191] Next, it will be explained with respect to a third
exemplified embodiment of a puncture device of the present
invention.
[0192] FIG. 9 is a perspective view showing a third exemplified
embodiment of a puncture device of the present invention. FIG. 10
is a cross-section view by A-A line in FIG. 9. Also, FIGS. 11A, 11B
and FIGS. 12A to 12C are diagrams (cross-section views) for
explaining usage of the puncture device shown in FIG. 9. It should
be noted hereinafter that it will be explained by assuming the
right side of FIG. 10 to FIG. 12 to be "rear-end" and the left side
thereof to be "tip".
[0193] As shown in FIG. 9 and FIG. 10, a puncture device 1 showing
a third exemplified embodiment of a puncture device of the present
invention is constituted by being provided with an adhesive pad 2
which is a fixing portion, a skin deforming means 3 for deforming
and uplifting the skin, a puncture needle moving means 4 for
retaining a puncture needle 411 to be movable and the like.
[0194] The adhesive pad 2 is made to be a plate body having such a
shape in which two elliptical plate bodies of different sizes are
formed continuously in the lateral direction and, so-called, a
wing-like shape is formed.
[0195] On the upper surface of the adhesive pad 2, the skin
deforming means 3 is arranged on the small ellipse side and the
puncture needle moving means 4 is arranged on the large ellipse
side thereof. In this manner, by constituting the area of the side
on which the puncture needle moving means 4 is arranged to be
large, it is possible to increase stability with respect to the
body surface F and to carry out the movement of the puncture needle
411 by means of the puncture needle moving means 4 in a stable
state.
[0196] There is provided at a position corresponding to the skin
deforming means 3 of the adhesive pad 2 with an opening window 21
for contacting a skin bonding member 33a to be described
hereinafter of the skin deforming means 3 to the body surface
F.
[0197] The lower surface of the adhesive pad 2 is made to be a
plane 2a for fixing the adhesive pad 2 by being appressed to the
body surface F. An adhesion means is provided on this plane 2a and
as the adhesion means, it is allowed to apply an adhesive agent on
the plane 2a in the form of laminae or it is also allowed to glue a
adhesive film of a two-sided tape thereon. It should be noted that
a bonding means is not provided on the plane 2a of a position which
corresponds to downside of a base member 31b. This is because it
becomes easy for the skin to be uplifted.
[0198] As shown in FIG. 10, the plane 2a of the adhesive pad 2 is
fixed on the body surface F by means of an adhesive agent. It
should be noted that there are arranged, on the lower side of the
body surface F, a stratum corneum SC, an epidermis E including the
stratum corneum SC, a dermis D and a subcutis S in the form of
laminae.
[0199] As the constituent material of such an adhesive pad 2, there
can be cited, for example, a soft polymer of flexible polyurethane
or the like.
[0200] The skin deforming means 3 is constituted by being provided
with the base member 31b fixed on the upper surface of the adhesive
pad 2, a magnet member 32a supported by this base member 31b to be
movable, a skin bonding member 33a pulled by the magnetic force of
the magnet member 32a so as to move and the like.
[0201] The base member 31b of the skin deforming means 3 is formed
by approximately a rectangular plate body and one of the side
surfaces of the short sides thereof is made to be continuous with a
support member 43 to be described hereinafter of the puncture
needle moving means 4. As shown in FIG. 10 and the like, there is
provided on the side of the puncture needle moving means 4 of the
base member 31b with a quadrangular through-hole 311 passing
through the upper and lower surfaces thereof, and this through-hole
311 faces to the opening window 21 of the adhesive pad 2.
[0202] There is formed on the inner surface of the through-hole 311
with a step portion 311a which is continuous in the circumferential
direction thereof. According to this step portion 311a, the
through-hole 311 is set such that the opening portion of the lower
surface side becomes smaller than the opening portion of the upper
surface side.
[0203] Guide pins 34a showing one embodiment of a guide member for
guiding the movement of the skin bonding member 33a are fixed at
the four corners of the step portion 311a of the through-hole 311
respectively. The four guide pins 34a are extended approximately
perpendicularly toward the upper portion respectively and by these
guide pins 34a, the skin bonding member 33a is guided approximately
in the perpendicular direction with respect to the base member
31b.
[0204] Also, as shown in FIG. 9 and the like, there are provided on
both the side surfaces of the long side of the base member 31b with
guide grooves 312, 312 (only one thereof is shown in FIG. 9). Slide
rails 321c, 321c to be described hereinafter of the magnet member
32a are engaged with these guide grooves 312, 312 slidably,
respectively.
[0205] The magnet member 32a is constituted by a moving table 321
supported by the base member 31b to be movable slidably and a
magnet 322 mounted on this moving table 321.
[0206] The moving table 321 of the magnet member 32a is composed of
a mounting plate 321a formed by approximately a quadrangular plate
body, a pair of side surface plates 321b, 321b which are extended
to the lower side continuously on the two facing sides of this
mounting plate 321a respectively and the like.
[0207] There is mounted on the upper surface of the mounting plate
321a with the magnet 322 forming a flat plate body by means of
firmly-fixing means of adhesive agent or the like. This magnet 322
is arranged such that pulling force is operated with respect to the
skin bonding member 33a each other.
[0208] In this manner, in a state in which the skin bonding member
33a is pulled by means of the magnet 322 by mounting the magnet 322
on the upper surface of the mounting plate 321, it never happens
that the skin bonding member 33a will be directly attached firmly
to the magnet 322 thereof and it is possible to easily carry out
changeover between a state in which the skin bonding member 33a is
pulled and a state without being pulled. However, it is also
possible for the puncture device 1 of the present invention to be
made as a constitution in which the skin bonding member is pulled
and directly attached firmly to the magnet.
[0209] There are provided at the tip portion of the pair of side
surface plates 321b, 321b with slide rails 321c, 321c (only one
thereof is shown in FIG. 9) respectively. Then, by engaging these
slide rails 321c, 321c slidably with the guide grooves 312, 312 of
the base member 31b, the magnet member 32a having the moving table
321 is supported on the base member 31b to be movable slidably.
More specifically, the magnet member moving means for moving the
magnet member 32a is constituted by the slide rails 321c, 321c of
the moving table 321 and the guide grooves 312, 312 of the base
member 31b.
[0210] As shown in FIG. 9, FIG. 10 and the like, the skin bonding
member 33a is constituted by the main body plate 331 forming
approximately a quadrangular plate body and an adhesion protrusion
portion 332 inserted into the through-hole 311 of the base member
31b and the opening window 21 of the adhesive pad 2. This skin
bonding member 33a has around reasonable degree of strength for not
being deformed elastically and also is formed by a magnetic
material by which pulling force is operated with respect to the
magnet 322 each other. It is possible for the constituent material
of such a skin bonding member 33a to cite, for example, iron,
nickel, cobalt or the like.
[0211] There are provided on the main body plate 331 of the skin
bonding member 33a with guide openings 331a for making the
respective guide pins 34a fixed on the base member 31b to pass
there-through. Thereby, the skin bonding member 33a is guided in
the direction to which the four guide pins 34a are extended, in
other words, approximately in the perpendicular direction with
respect to the plane of the base member 31b.
[0212] The adhesion protrusion portion 322 of the skin bonding
member 33a projects on the lower surface of the main body plate 331
continuously and approximately perpendicularly and has an adhesion
surface 332a as a skin fixing plane which is a plane for being
fixed on the body surface F. The adhesion surface 332a of the
adhesion protrusion portion 332 is attached with adhesive film 35
showing one embodiment of the adhesion means. Thereby, the adhesion
surface 332a of the skin bonding member 33a is bonded on the body
surface F. For the adhesion means, for example, an adhesive film of
a two-sided tape or the like is used.
[0213] In this exemplified embodiment, the number of the guide pins
34a guiding the movement of the skin bonding member 33a is set to
be four, but the number thereof is not limited by this and it is
possible to set the number of the guide pins properly in
consideration of the shape of the skin bonding member or the like
in order to guide the movement of the skin bonding member thereof
stably.
[0214] The puncture needle moving means 4 is constituted by an
injector 41 mounted with a puncture needle 411, a mounting member
42 for mounting and fixing the injector 41, and a support member 43
for supporting the mounting member 42 to be movable.
[0215] The injector 41 is provided with the puncture needle 411, a
fixed outer cylinder 412, an internal outer cylinder 413 slidable
in the fixed outer cylinder 412, a gasket 414 slidable in the
internal outer cylinder 413, and a plunger 415 moving-operating the
gasket 414.
[0216] The fixed outer cylinder 412 has a cylindrical shape with
bottom and is mounted and fixed on the mounting member 42 by means
of adhesive agent or the like. Also, there is formed in the
vicinity of the central portion of the bottom portion of the fixed
outer cylinder 412 with a puncture needle opening 412a for carrying
out insertion of the puncture needle 411.
[0217] The internal outer cylinder 413 has a cylindrical shape with
bottom. Also, the puncture needle 411 is mounted in the vicinity of
the central portion of the bottom portion.
[0218] The needlepoint 411a of the puncture needle 411 is provided
so as not to project from the puncture needle opening 412a provided
at the fixed outer cylinder 412. More specifically, the puncture
needle 411 is located with respect to the fixed outer cylinder 412
such that the needlepoint 411a thereof is positioned in the inner
side as compared with the bottom face of the fixed outer cylinder
412 on which the puncture needle opening 412a is provided and also
in the vicinity of the puncture needle opening 412a.
[0219] By constituting in this manner, the needlepoint 411a of the
puncture needle 411 is protected. For that reason, it is possible
to prevent a finger or the like from touching the needlepoint 411a
of the puncture needle 411 or to prevent the puncture needle 411
from puncturing the finger or the like accidentally, and it is
possible to maintain the puncture needle 4 in a clean state. Also,
it never happens that the puncture needle 411 directly receives an
impact from the outside and it is possible to prevent the puncture
needle 411 from being deformed by the impact.
[0220] The outer diameter of the puncture needle 411 is a little
bit different depending on the use application or the like of the
puncture device 1, but it is preferable to select it as around 0.05
to 2 mm and in particular, preferable to select it as around 0.1 to
1.5 mm.
[0221] There can be cited, for the constituent material of the
puncture needle 411, metal materials such as, for example,
stainless steel, aluminum or aluminum alloy, titanium or titanium
alloy and the like. Also, the puncture needle 411 is manufactured,
for example, by plastic working.
[0222] It is possible for the internal outer cylinder 413 to slide
in the fixed outer cylinder 412 in a longitudinal direction of the
internal outer cylinder 413 by means of the operation of the
plunger 415 and when the internal outer cylinder 413 slides, the
puncture needle 411 firmly fixed to the internal outer cylinder 413
is taken in and out with respect to the fixed outer cylinder 412
through the puncture needle opening 412a.
[0223] For the constituent material of the fixed outer cylinder 412
and the internal outer cylinder 413, there can be cited various
kinds of resins such, for example, as polyvinylchloride,
polyethylene, polypropylene and the like. It should be noted that
the constituent material of the fixed outer cylinder 412 and the
internal outer cylinder 413 is desirable to be substantially
transparent in order to ensure visibility of the inside.
[0224] There is housed, in the internal outer cylinder 413, the
gasket 414 constituted by an elastic material.
[0225] For the constituent material of the gasket 414, although it
is not limited in particular, there can be cited, for example,
various kinds of rubber materials such as natural rubber and
silicone rubber, various kinds of thermoplastic elastomers of
polyurethane series, styrene series and the like or elastic
materials of mixtures thereof and the like.
[0226] In the space surrounded by the gasket 414 and internal outer
cylinder 413, a liquid room 417 is formed and in this liquid room
417, liquid is contained liquid-tightly beforehand.
[0227] There can be cited for the liquid, for example, remedy for
injection or medicinal solution using a macromolecular substance
such as hormone, antibody drug, cytokine, vaccine or the like.
[0228] There is interlinked to the gasket 414 the plunger 415 which
moving-operate the gasket 414 in the internal outer cylinder 413 in
a longitudinal direction.
[0229] A plate-like flange 416 is formed integrally at the rear end
of the plunger 415. The plunger 415 is operated by depressing this
flange 416 with a finger or the like.
[0230] The mounting member 42 is formed by a rectangular plate body
and there are provided on both the side surfaces of the long side
with engagement portions 421, 421. These engagement portions 421,
421 are slidably engaged with engagement convex portions 431, 431
to be described hereinafter of the support member 43. Then, a fixed
outer cylinder 412 of the injector 41 is fixed to an upper surface
portion 42a of the mounting member 42.
[0231] The support member 43 is formed by a rectangular plate body
which is set to be thicker than the mounting member 42 and an edge
portion on the tip side thereof is made to be continuous with one
side surface of the short sides of the base member 31b. Thereby,
the skin deforming means and the puncture needle moving means 4 are
constituted integrally. An firmly-fixing means of an adhesive agent
or the like is mounted on a lower surface portion 43b of the
support member 43 and as shown in FIG. 10, it is bonded and fixed
on the upper surface of the adhesive pad 2.
[0232] There are provided on both the side surfaces of the long
sides of the support member 43 with engagement convex portions 431,
431. Then, owing to a mechanism that the engagement portions 421,
421 of the mounting member 42 are engaged slidably with these
engagement convex portions 431, 431, the mounting member 42 is
supported by the support member 43 to be movable.
[0233] The upper surface portion 43a of the support member 43 is
made to be parallel with respect to the plane of the adhesive pad 2
and the adhesion surface 332a of the skin bonding member 33a. For
that reason, the mounting member 42 moved along the upper surface
portion 43a of the support member 43 is made to move in parallel
with respect to the plane of the adhesive pad 2 and the adhesion
surface 332a of the skin bonding member 33a. Also, an axis center
line of the puncture needle 411 mounted on the injector 41 is made
to coincide with the moving direction of the mounting member
42.
[0234] It is possible for the constituent material of the mounting
member 42 and the support member 43 of the puncture needle moving
means 4, and of the base member 31b and the moving table 321 of the
skin deforming means 3 to cite, for example, various kinds of
synthetic resins having appropriate strength such as acrylic resin,
ABS resin and the like, but it is not limited by this material and
it is also possible to use a metal such as aluminum alloy or the
like.
[0235] It should be noted as the puncture needle moving means 4
that it is allowed to employ such a constitution wherein an
injector having a constitution in which a puncture needle and a
syringe are formed as one body configuration is fixed and retained
on the mounting member 42. In this case, the length of the puncture
needle 411 is adjusted such that the needlepoint 411a of the
puncture needle 411 can puncture the skin uplifted by the skin
deforming means 3 when the mounting member 42 is moved so as to
most approach to the skin deforming means 3.
[0236] Also, a constitution is employed in this exemplified
embodiment in which the injector 41 is provided in the puncture
needle moving means 4 and the puncture needle 411 is mounted on the
injector thereof, but it is not limited by this constitution and it
is allowed to employ, for example, a constitution in which a tube
for communicating with the side opposite to the needlepoint 411a of
the puncture needle 411 is provided and the other terminal of that
tube is made to communicate with an infusion device such as a
liquid transmission pump or the like.
[0237] Next, it will be explained with respect to the usage
(operation) of the puncture device 1 of the third exemplified
embodiment.
[0238] First, as shown in FIG. 11A, the puncture device 1 in which
the magnet member 32a is arranged on the tip side of the base
member 31b beforehand is mounted on a predetermined position of the
body surface F. At that time, the puncture device 1 is bonded and
fixed on the body surface F by means of an adhesive film provided
on the plane 2a which is the lower surface of the adhesive pad
2.
[0239] Next, the skin bonding member 33a is depressed downward and
the adhesion surface 332a of the skin bonding member 33a is bonded
to the body surface F by means of the adhesive film 35.
[0240] Subsequently, as shown in FIG. 11B, the magnet member 32a of
the skin deforming means 3 is moved slidably and the magnet 322 of
the magnet member 32a is made to face to the skin bonding member
33a. Thereby, the skin bonding member 33a is pulled by the magnet
322, guided by the four pins 34a and moved upward. Then, it is
retained in a state of being contacted to the mounting plate 321a
of the moving table 321.
[0241] Concurrently with this, the skin bonded to the adhesion
surface 332a of the skin bonding member 33a is pulled upward. More
specifically, the epidermis E including the stratum corneum SC, the
dermis D and the subcutis S are pulled upward respectively and the
skin is uplifted to the vertical direction with respect to the body
surface F. At that time, the dermis D of the uplifted skin or the
like is made to be in a state approximately parallel with the
adhesion surface 332a of the skin bonding member 33a.
[0242] More specifically, depending on a fact that the skin is
deformed and uplifted, the position of the plane 2a of the adhesive
pad 2, which is the fixing portion and the position of the adhesion
surface 332a as the skin fixing plane become different in the
height direction, a step portion is formed there-between and the
puncture needle 411 is stuck into the step portion thereof.
[0243] Further, the height from the body surface F to the mounting
plate 321a of the moving table 321 is set to be a predetermined
height, so that it becomes a state in which the height of the
dermis D of the skin pulled up by the skin bonding member 33 and
the height by which the puncture needle 411 of the puncture needle
moving means 4 is located will coincide with each other.
[0244] Next, the mounting member 42 on which the injector 41 is
fixedly retained is slided to the tip direction. More specifically,
the bottom face of the fixed outer cylinder 412 and the side
surface of the uplifted skin are made to be adjacent and the
needlepoint 411a of the puncture needle 411 is made to approach to
the side surface of the uplifted skin.
[0245] Next, the plunger 415 is operated by depressing the flange
416 with a finger or the like and the internal outer cylinder 413
is moved to the tip direction while being slided in the fixed outer
cylinder 412. Thereby, the puncture needle 411 firmly fixed on the
internal outer cylinder 413 is inserted into a puncture region
(step portion) from the puncture needle opening 412a and as shown
in FIG. 12A, the needlepoint 411a of the puncture needle 411 is
stuck in parallel with respect to the dermis D by bypassing the
epidermis E including the stratum corneum SC.
[0246] The plunger 415 is operated by further depressing the flange
416 with a finger or the like from that state and the gasket 414 is
moved to the tip direction while sliding it in the internal outer
cylinder 413. Thereby, as shown in FIG. 12B, the liquid contained
in the liquid room 417 is injected from the needlepoint 411a of the
puncture needle 411 to the dermis D.
[0247] After the liquid is injected into the dermis D and
thereafter, the mounting member 42 is moved to the rear end
direction and the puncture needle 411 is pulled out from the
uplifted skin.
[0248] Further, the plunger 415 is moved to the rear end direction
and the puncture needle 411 is housed in the fixed outer cylinder
412 through the puncture needle opening 421a.
[0249] Next, maintaining this state, the mounting member 42 on
which the injector 41 is fixedly retained is slided to the rear end
side and it is made to be a state of FIG. 12C and thereafter, the
magnet member 32a is moved slidably to the tip side and the
uplifted skin is made to return to the original state. Then,
finally, the adhesion of the adhesive pad 2 and the skin bonding
member 33a with respect to the body surface F is released and the
puncture device 1 is exfoliated from the body surface F.
[0250] In this exemplified embodiment, a constitution is employed
wherein a state in which the skin bonding member 33a is pulled and
a state without being pulled are changed over by slidably moving
the magnet member 32a, but it is not limited by this configuration
and it is allowed to employ, for example, a constitution wherein a
state in which the skin bonding member 33a is pulled and a state
without being pulled are changed over by arranging an electromagnet
at a position facing to the skin bonding member 33a and by
operating it for the energization thereof.
[0251] As explained above, according to the puncture device of this
exemplified embodiment, it is possible in case of, for example,
puncturing the dermis D, to pull up the dermis D of the skin to an
equivalent height as the puncture needle by uplifting the skin by
means of the skin deforming means and at the same time, it is
possible to make the axis center line of the puncture needle
thereof and the direction to which the dermis D layer is extended
to be approximately in parallel. As a result thereof, it is
possible to insert the puncture needle into the dermis D certainly
and deeply, and even in a case in which a impact or the like is
added from the outside, it is possible to prevent the puncture
needle from dropping out easily from the dermis D during injecting
a medical agent.
[0252] Further, it is possible to insert the puncture needle into
the dermis D deeply, so that it becomes possible to lengthen the
distance from the medical agent releasing aperture which exists at
the needlepoint of the puncture needle to the epidermis E and the
body surface F, so that it is possible to prevent the medical agent
injected from the medical agent releasing aperture to the dermis D
from flowing back [backward] and permeating the epidermis E or from
leaking to the outside of the body surface F. Accordingly, it is
possible to inject the medical agent into the dermis D
certainly.
[0253] Also, the skin deforming means and the puncture needle
moving means are constituted integrally by being continuous, so
that it is possible when carrying out the assembling operation to
omit an operation such as position adjustment or the like of the
puncture needle moving means with respect to the skin deforming
means and it is possible to improve workability on an occasion of
assembling. Further, it is possible to accurately set the position
of the puncture needle with respect to the skin to be uplifted and
it is possible to stick the puncture needle to the dermis D
certainly.
[0254] It is also possible for the puncture device of the present
invention to be used for implanting a cannula other than an object
in which, as being described so far, a medical agent is injected by
one-shot. In this case, the cannula is retained with the puncture
needle and by leaving the cannula after the puncture and taking out
only the puncture needle, the cannula is implanted inside the skin.
By implanting a hollow cannula which has an opening at the
implanted portion, it is possible to use it for an object of
continuous administration of a medical agent or for an object of
sampling of the body fluid component. In addition, by implanting a
catheter which has a sensor in the implanted portion, it is also
possible to carry out measurement of the body component.
FOURTH EXEMPLIFIED EMBODIMENT
[0255] Next, it will be explained with respect to a fourth
exemplified embodiment of a puncture device of the present
invention.
[0256] FIG. 13 is a perspective view showing a fourth exemplified
embodiment of a puncture device of the present invention. FIG. 14
is a diagram showing a cross-section view by A-A line in FIG. 13.
Also, FIG. 15 and FIG. 16 are diagrams (cross-section views) for
explaining usage of the puncture device shown in FIG. 13. It should
be noted that it will be explained hereinafter on an assumption
that the right side in FIG. 14 to FIG. 16 is made to be "rear end"
and the left side thereof is made to be "tip".
[0257] A puncture device 1 shown in FIG. 13 is constituted by being
provided with an adhesive pad 2 which is a fixing portion, a skin
deforming means 3 for deforming and uplifting the skin, a puncture
needle moving means 4 for retaining a puncture needle 411 to be
movable and the like.
[0258] The adhesive pad 2 is almost rounded and is formed so as to
have a shape in which facing concave portions are formed at
portions of the circumference thereof, so-called, a wing-like
shape.
[0259] It should be noted that the wing-like shape of the adhesive
pad 2 is formed such that the area of the side on which the
puncture needle moving means 4 is mounted becomes larger than the
area of the side on which the skin deforming means 3 is provided.
In this manner, by making the area of the adhesive pad 2 on the
side on which the puncture needle moving means 4 is mounted to be
larger, it is possible to increase stability with respect to a body
surface F and to carry out the movement of the puncture needle 411
by means of the puncture needle moving means 4 in a stable
state.
[0260] The adhesive pad 2 is formed with a through-hole 21 for
mounting a main body portion 5x of a box shape, which is the skin
deforming means 3 on the body surface F.
[0261] As shown in FIG. 14, there is formed on the body surface F
side of the adhesive pad 2 with a plane 2a for fixing the adhesive
pad 2 by being appressed to the body surface F. An adhesion means
is provided on this plane 2a and as the adhesion means, it is
allowed to apply an adhesive agent on the plane 2a in the form of
laminae or it is also allowed to glue an adhesive film constituted
by a two-sided tape thereon.
[0262] The plane 2a of the adhesive pad 2 is fixed on the body
surface F by being appressed thereto by means of an adhesive agent.
It should be noted that there are arranged, on the lower side of
the body surface F, a stratum corneum SC, an epidermis E including
the stratum corneum SC, a dermis D and a subcutis S in the form of
laminae.
[0263] Then, as being described hereinafter, the puncture needle
411 is moved to the tip direction along the plane 2a of the
adhesive pad 2 by the puncture needle moving means 4 and the skin
uplifted by the skin deforming means 3 is to be punctured.
[0264] The adhesive pad 2 is constituted, for example, by soft
polymer such as flexible polyurethane or the like.
[0265] The skin deforming means 3 is constituted by the main body
portion 5x and a suction means 6.
[0266] The main body portion 5x is constituted by a tubular member
with a bottom, is formed by a bottom face portion 5a having
approximately a square shaped plate at the base end and a
peripheral wall portion 5b having a plurality of planes juncturally
positioned at this bottom face portion 5a and has a box shape (BOX
SHAPE).
[0267] There is formed on the body surface F side of the bottom
face portion 5a with a skin fixing plane 5e for fixing the skin
uplifted by the skin deforming means 3.
[0268] Also, as shown in FIG. 14, there is formed on the body
surface F side of the main body portion 5x with an opening portion
52a in which it is constituted to be opened up toward the body
surface F. This main body portion 5x has a constitution in which a
space 51a formed in the inside thereof is to be hermetically-closed
(sealed to be airtight) by pressing the opening portion 52a to the
skin (body surface F).
[0269] Also, a flange portion 5d is formed on the circumference
surface of the tip of the main body portion 5x. It is possible by
providing the flange portion 5d to improve airtightness of the
space 51a when pressing the opening portion 52a to the body surface
F.
[0270] An elastic body 6 having a hollow portion 61 as a suction
means is firmly-fixed (fixed) on the outer surface (upper surface)
of the bottom face portion 5a.
[0271] The elastic body 6 has a cube shape and is constituted by an
elastically deformable member. Also, the hollow portion 61 is
formed inside the elastic body 6. It should be noted that the shape
of the elastic body 6 is limited by the cube shape such as this
exemplified embodiment.
[0272] Also, a through-hole 7 is formed at the central portion of
the bottom face portion 5a of the main body portion 5x. Thereby,
the hollow portion 61 of the elastic body 6 and the space 51a of
the main body portion 5x are in communication with each other by
way of the through-hole 7.
[0273] Also, there is provided on the inner surface (lower surface)
of the bottom face portion 5a with an adhesive film 8 as a skin
adhesion means.
[0274] The adhesive film 8 is provided also on the inner surface of
the peripheral wall portion 5b. This adhesive film 8 is provided so
as to cover an insertion opening 5c formed on the peripheral wall
portion 5b, so that it is possible to improve the airtightness of
the space 51a.
[0275] By pressing the opening portion 52a of the main body portion
5x to the body surface F in a state in which the elastic body 6 is
compressed and by releasing the compressed state of the elastic
body 6, air in the space 51a is sucked into the hollow portion 61
of the elastic body 6 and it is possible to depressurize the space
51a.
[0276] For the constituent material of the elastic body 6, there
can be cited various kinds of rubber materials such as natural
rubber, isoprene rubber, butadiene rubber, styrene-butadiene
rubber, nitrile rubber, chloroprene rubber, butyl rubber, acrylic
rubber, ethylene-propylene rubber, hydrin rubber, urethane rubber,
silicone rubber, fluoro-rubber and the like or various kinds of
thermoplastic elastomers such as styrene series, polyolefin series,
polyvinylchloride series, polyurethane series, polyester series,
polyamide series, polybutadiene series, fluoro-rubber series and
the like.
[0277] It should be noted for the suction means that it is allowed
to employ such a constitution wherein, for example, a syringe is
fixed at an edge portion of a tube which is made to be in
communication with the space 51a and the air in the space 51a is to
be sucked by the operation of the syringe.
[0278] There is formed on the plane 50a facing to the puncture
needle moving means 4 among the planes of the peripheral wall
portion 5b with the insertion opening 5c as a through-hole.
Thereby, through the insertion opening 5c, the puncture needle 411
moved by the puncture needle moving means 4 is inserted into the
inside of the main body portion 5x.
[0279] The puncture needle moving means 4 is constituted by an
injector 41 having the puncture needle 411, a mounting member 42
for mounting and fixing the injector 41 and a support member 43 for
supporting the mounting member 42 to be movable.
[0280] The injector 41 is provided with the puncture needle 411, a
fixed outer cylinder 412, an internal outer cylinder 413 slidable
in the fixed outer cylinder 412, a gasket 414 slidable in the
internal outer cylinder 413 and a plunger 415 which moving-operates
the gasket 414.
[0281] The fixed outer cylinder 412 has a cylindrical shape with
bottom and is mounted and fixed on the mounting member 42 by means
of adhesive agent or the like. Also, there is formed in the
vicinity of the central portion of the bottom portion of the fixed
outer cylinder 412 with a puncture needle opening 412a for carrying
out insertion of the puncture needle 411.
[0282] The internal outer cylinder 413 has a cylindrical shape with
bottom. Also, the puncture needle 411 is firmly fixed by adhesion
in the vicinity of the central portion of bottom portion.
[0283] The needlepoint 411a of the puncture needle 411 is provided
so as not to project from the puncture needle opening 412a provided
at the fixed outer cylinder 412. More specifically, the puncture
needle 411 is located with respect to the fixed outer cylinder 412
such that the needlepoint 411a thereof is positioned in the inner
side as compared with the bottom face of the fixed outer cylinder
412 on which the puncture needle opening 412a is provided and also
in the vicinity of the puncture needle opening 412a.
[0284] It is possible by constituting in this manner to protect the
needlepoint 411a of the puncture needle 411. Also, it is possible
to reduce awful feeling of a user, because the needlepoint 411a
becomes hard to be seen.
[0285] The outer diameter of the puncture needle 411 is a little
bit different depending on the use application or the like of the
puncture device 1, but it is preferable to select it as around 0.05
to 2.5 mm and in particular, preferable to select it as around 0.1
to 1.5 mm.
[0286] There can be cited, for the constituent material of the
puncture needle 411, metal materials such as, for example,
stainless steel, aluminum or aluminum alloy, titanium or titanium
alloy and the like. Also, the puncture needle 411 is manufactured,
for example, by plastic working.
[0287] It is possible for the internal outer cylinder 413 to slide
in the fixed outer cylinder 412 in a longitudinal direction of the
internal outer cylinder 413 by means of the operation of the
plunger 415 and when the internal outer cylinder 413 slides, the
puncture needle 411 firmly fixed to the internal outer cylinder 413
is taken in and out with respect to the fixed outer cylinder 412
through the puncture needle opening 412a.
[0288] For the constituent material of the fixed outer cylinder 412
and the internal outer cylinder 413, there can be cited various
kinds of resins such, for example, as polyvinylchloride,
polyethylene, polypropylene and the like. It should be noted that
the constituent material of the fixed outer cylinder 412 and the
internal outer cylinder 413 is desirable to be substantially
transparent in order to ensure visibility of the inside.
[0289] There is housed, in the internal outer cylinder 413, the
gasket 414 constituted by an elastic material.
[0290] For the constituent material of the gasket 414, although it
is not limited in particular, there can be cited, for example,
various kinds of rubber materials such as natural rubber and
silicone rubber, various kinds of thermoplastic elastomers of
polyurethane series, styrene series and the like or elastic
materials of mixtures thereof and the like.
[0291] In the space surrounded by the gasket 414 and internal outer
cylinder 413, a liquid room 417 is formed and in this liquid room
417, liquid is contained liquid-tightly beforehand.
[0292] There can be cited for the liquid, for example, remedy for
injection or medicinal solution using a macromolecular substance
such as hormone, antibody drug, cytokine, vaccine or the like.
erate the gasket 414 in the internal outer cylinder 413 in a
longitudinal direction.
[0293] A plate-like flange 416 is formed integrally at the rear end
of the plunger 415. The plunger 415 is operated by depressing this
flange 416 with a finger or the like.
[0294] The mounting member 42 is constituted so as to include an
upper surface portion 42a for mounting the injector 41. At the edge
portion in a longitudinal direction of the surface portion 42a,
there is formed, by being projected toward the adhesive pad 2, a
U-shaped engagement portion 421 to be movable and for being engaged
with the support member 43.
[0295] The support member 43 is constituted by a rectangular
plate-like body having an upper surface portion 43a which contacts
slidably with a mounting member 421. At the edge portion in a
longitudinal direction of the support member 43, there is formed,
by being projected to the horizontal direction with respect to the
adhesive pad 2, an engagement convex portion 431 which has such a
shape to coincide with the U-shaped engagement portion 421 which is
formed on the mounting member 42.
[0296] On the plane on the opposite side of the upper surface
portion 43a of the support member 43, there is formed a lower
surface portion 43b for being fixed with the adhesive pad 2
adhesively. As shown in FIG. 14, the lower surface portion 43b of
the support member 43 is fixed on the adhesive pad 2 by adhesive
agent or the like.
[0297] There can be cited for the constituent material of the
mounting member 42 and the support member 43 various kinds of
resins such as polyethylene, polypropylene or the like and the
mounting member 42 and the support member 43 are manufactured by a
forming process inpouring these resins into a die which has a
predetermined shape or the like.
[0298] It should be noted as the puncture needle moving means 4
that it is allowed to employ such a constitution wherein an
injector having a constitution in which a puncture needle and a
syringe are formed as one body configuration is fixed and retained
on the mounting member 42. In this case, the length of the puncture
needle 411 is adjusted such that the needlepoint 411a of the
puncture needle 411 can puncture the skin uplifted by the skin
deforming means 3 when the mounting member 42 is moved so as to
most approach to the skin deforming means 3.
[0299] Next, it will be explained by using FIG. 15 and FIG. 16 with
respect to usage (operation) of the puncture device 1 of this
exemplified embodiment.
[0300] First, the adhesive pad 2 is mounted on a predetermined
position of the body surface F. At that time, the plane 2a of the
adhesive pad 2 is bonded and fixed on the body surface F by means
of an adhesive film provided on the body surface F side of the
adhesive pad 2. In this state, the main body portion 5x is inserted
into the through-hole 21 formed on the adhesive pad 2 and by
contacting and fixing the flange 5d onto the body surface F, the
main body portion 5x is mounted on the body surface F.
[0301] In this case, as shown in FIG. 15A, the elastic body 6 is
deformed by being grasped with a finger or the like and the air in
the hollow portion 61 of the elastic body 6 is exhausted.
[0302] Next, as shown in FIG. 15B, the finger is released from the
elastic body 6 and the compressed state of the elastic body 6 is
released, and then the air in the space 51a is sucked into the
hollow portion 61 through the through-hole 7 as shown by
arrows.
[0303] Thereby, the space 51a is depressurize and the skin on the
inner side of the opening portion 52a is uplifted into the space
51a. More specifically, the epidermis E including the stratum
corneum SC, the dermis D and the subcutis S are pulled upward
respectively and the skin is uplifted to the vertical direction
with respect to the body surface F.
[0304] More specifically, the position of the plane 2a of the
adhesive pad 2, which is the fixing portion and the position of the
skin fixing plane 5e formed in the main body portion 5x become
different in the height direction, so that a step portion is formed
there-between and the puncture needle 411 is inserted into the step
portion thereof and stuck into the uplifted and deformed skin.
[0305] Then, the skin uplifted into the space 51a contacts with the
adhesive film 8 provided on the bottom face portion 5a and on the
peripheral wall portion 5b and is fixed thereon adhesively. At that
time, a portion of the body surface F is fixed so as to become in
parallel with the bottom face portion 5a, so that also a portion of
the dermis D is fixed in the main body portion 5x so as to become
in parallel with the bottom face portion 5a.
[0306] Next, the mounting member 42 on which the injector 41 is
fixedly retained is slided to the tip direction.
[0307] Next, the plunger 415 is operated by depressing the flange
416 with a finger or the like and the internal outer cylinder 413
is moved to the tip direction while being slided in the fixed outer
cylinder 412. Thereby, the puncture needle 411 firmly fixed on the
internal outer cylinder 413 is inserted from the puncture needle
opening 412a into the insertion opening 5c provided on the
peripheral wall portion 5b.
[0308] At that time, the puncture needle 411 is punctured in a
state in parallel with the skin fixing plane 5e provided on the
bottom face portion 5a, so that, as shown in FIG. 15C, the puncture
needle 411 is stuck in the skin in a state in parallel with the
dermis D.
[0309] The plunger 415 is operated by further depressing the flange
416 with a finger or the like from that state and the gasket 414 is
moved to the tip direction while sliding it in the internal outer
cylinder 413. Thereby, as shown in FIG. 16A, a medical agent 50
contained in the liquid room 417 is injected from the needlepoint
411a of the puncture needle 411 to the dermis D.
[0310] After the medical agent is injected into the dermis D, the
plunger 415 is operated by pulling the flange 416 with a finger or
the like, the gasket 414 is moved to the rear end direction and the
puncture needle 411 is pulled out from the dermis D.
[0311] Further, the plunger 415 is moved to the rear end direction
and as shown in FIG. 16B, the puncture needle 411 is housed in the
fixed outer cylinder 412 through the puncture needle opening
421a.
[0312] Next, in a state in which the puncture needle 411 is housed
in the fixed outer cylinder 412, the mounting member 42 is slided
to the rear end direction and it is made to be a state of FIG.
16C.
[0313] Concurrently, the elastic body 6 is depressed and deformed
by a finger or the like and the air in the hollow portion 61 is
sent to the space 51a of the main body portion 5x. Thereby, the
space 51a is pressurized and the skin uplifted in the space 51a
returns to the original state.
[0314] In this manner, according to the puncture device 1 of this
exemplified embodiment, in a state in which the opening portion 52b
of the main body portion 5x is pressed to the body surface F the
air in the space 51a is sucked by the elastic body 6 so as to
depressurize the space 51a. Thereby, the skin including the dermis
D is uplifted in the space 51a and the skin is fixed by the
adhesive film 8 provided on the bottom face 2a and thereafter, it
is possible to puncture the dermis D by the puncture needle 411.
More specifically, the puncture operation is carried out in a state
in which the skin is uplifted, so that it is possible to stick the
puncture needle 411 into the skin (dermis D) certainly and also, it
is possible to inject a medical agent to the dermis D of the skin
certainly.
[0315] Also, the puncture needle 411 is stuck into the dermis D in
the skin approximately in a parallel state, so that the insertion
depth of the puncture needle 411 in the inside of the dermis D
becomes long and even in a case in which an impact or the like is
added from the outside, the puncture needle 411 during injecting
the medical agent can be prevented from dropping out from the
dermis D.
[0316] Also, the distance from the insertion aperture of the
puncture needle 411, which is formed at a boundary portion between
the epidermis E and the dermis D to the medical agent releasing
aperture which exists at the needlepoint 411a becomes long, so that
the medical agent once injected into the dermis D from the medical
agent releasing aperture can be prevented from leaking from the
insertion aperture to the epidermis E by being flown back
[backward].
FIFTH EXEMPLIFIED EMBODIMENT
[0317] Next, it will be explained with respect to a fifth
exemplified embodiment of a puncture device of the present
invention.
[0318] FIG. 17 is a perspective view showing a fifth exemplified
embodiment of a puncture device of the present invention. FIG. 18
is a diagram showing a cross-section view by A-A line in FIG.
17.
[0319] Also, FIG. 19 and FIG. 20 are diagrams (cross-section view)
for explaining the usage of the puncture device shown in FIG.
17.
[0320] It should be noted that it will be explained hereinafter on
an assumption that the right side in FIG. 18 to FIG. 20 is made to
be "rear end" and the left side thereof is made to be "tip".
[0321] A puncture device 1 shown in FIG. 17 is constituted by being
provided with an adhesive pad 2 which is a fixing portion, a skin
deforming means 3 for deforming and uplifting the skin, a puncture
needle moving means 4 for retaining a puncture needle 411 to be
movable and the like.
[0322] The adhesive pad 2 is almost rounded and is formed so as to
have a shape in which facing cocave portions are formed at portions
of the circumference thereof, so-called, a wing-like shape.
[0323] It should be noted that the wing-like shape of the adhesive
pad 2 is formed such that the area of the side on which the
puncture needle moving means 4 is mounted becomes larger than the
area of the side on which the skin deforming means 3 is provided.
In this manner, by making the area of the adhesive pad 2 on the
side on which the puncture needle moving means 4 is mounted to be
larger, it is possible to increase stability with respect to a body
surface F and to carry out the movement of the puncture needle 411
by means of the puncture needle moving means 4 in a stable
state.
[0324] The adhesive pad 2 is formed with a through-hole 21 for
mounting the skin deforming means 3 on the body surface F.
[0325] As shown in FIG. 18, there is formed on the body surface F
side of the adhesive pad 2 with a plane 2a for fixing the adhesive
pad 2 by being appressed to the body surface F. An adhesion means
is provided on this plane 2a and as the adhesion means, it is
allowed to apply an adhesive agent on the plane 2a in the form of
laminae or it is also allowed to glue an adhesive film constituted
by a two-sided tape thereon.
[0326] The plane 2a of the adhesive pad 2 is fixed on the body
surface F by being appressed thereto by means of an adhesive agent.
It should be noted that there are arranged, on the lower side of
the body surface F, a stratum corneum SC, an epidermis E including
the stratum corneum SC, a dermis D and a subcutis S in the form of
laminae.
[0327] Then, as being described hereinafter, the puncture needle
411 is moved to the tip direction along the plane 2a of the
adhesive pad 2 by the puncture needle moving means 4 and the skin
uplifted by the skin deforming means 3 is to be punctured.
[0328] There can be cited for the constituent material of such an
adhesive pad 2, for example, soft polymer such as flexible
polyurethane or the like.
[0329] The skin deforming means 3 is provided with a tabular member
5y, handles 6a mounted on the tabular member 5y and an outer frame
7x retaining the handles 6a to be movable.
[0330] The tabular member 5y has flexibility and is constituted by
a bendable flat plate of approximately a square shape. It should be
noted that approximately a square shape configuration is employed
in this exemplified embodiment, but it is allowed to employ, for
example, a rectangle shape configuration.
[0331] Also, as shown in FIG. 18, there is formed on the surface of
the tabular member 5y on the body surface F side with a skin fixing
plane 5e and there is provided on this skin fixing plane 5e with an
adhesive film 8 as a skin bonding means.
[0332] The adhesive film 8 is provided at least on the side on
which the handle 6a of the tabular member 5y is provided and on the
center line 5a of the tabular member 5y so as to be along
therewith. It should be noted as the skin bonding means that it is
allowed to apply an adhesive agent on the tabular member 5 in the
form of laminae.
[0333] It is enough for the constituent material of such a tabular
member 5y if only it is a material which is deformable by a finger
or the like and has adequate elasticity and, for example, metal
materials and various kinds of resins can be cited.
[0334] The handle 6a is constituted by a L-shaped member and is
firmly fixed on the side portion of the tabular member 5y by means
of an adhesive agent.
[0335] The position on which the handle 6a is firmly fixed is in
the vicinity of the central portion on the side, among the four
sides which the tabular member 5y has, which is in parallel with
the moving direction of the puncture needle 411 and two handles 6a
are mounted on the tabular member 5y so as to become symmetrical to
each other.
[0336] The outer frame 7x is constituted by a cube shaped member
and has four side surfaces. Also, the outer frame 7x is formed with
an opening 51b toward the body surface F side.
[0337] Also, there are formed on the body surface F side of the two
side surfaces 72 which become parallel with the moving direction of
the puncture needle 411 with engagement openings (not shown) for
engaging with the handles 6a, respectively.
[0338] The two handles 6a are engaged with the engagement openings
so as to be movable with respect to the outer frame 7x. More
specifically, the outer frame 7x is constituted such that the
handles 6a are retained thereon to be movable.
[0339] Also, there is formed on a side surface 71, facing to the
puncture needle moving means 4, of the outer frame 7x with an
insertion opening 7a. The insertion opening 7a is formed so as to
have a half round shape and the puncture needle 411 is inserted
into the outer frame 7x through this insertion opening 7a by means
of the puncture needle moving means 4.
[0340] The puncture needle moving means 4 is constituted by an
injector 41 having the puncture needle 411, a mounting member 42
for mounting and fixing the injector 41 and a support member 43 for
supporting the mounting member 42 to be movable.
[0341] The injector 41 is provided with the puncture needle 411, a
fixed outer cylinder 412, an internal outer cylinder 413 slidable
in the fixed outer cylinder 412, a gasket 414 slidable in the
internal outer cylinder 413 and a plunger 415 which moving-operates
the gasket 414.
[0342] The fixed outer cylinder 412 has a cylindrical shape with
bottom and is mounted and fixed on the mounting member 42 by means
of adhesive agent or the like. Also, there is formed in the
vicinity of the central portion of the bottom portion of the fixed
outer cylinder 412 with a puncture needle opening 412a for carrying
out insertion of the puncture needle 411.
[0343] The internal outer cylinder 413 has a cylindrical shape with
bottom. Also, the puncture needle 411 is firmly fixed by adhesion
in the vicinity of the central portion of bottom portion.
[0344] The needlepoint 411a of the puncture needle 411 is provided
so as not to project from the puncture needle opening 412a provided
a the fixed outer cylinder 412. More specifically, the puncture
needle 411 is located with respect to the fixed outer cylinder 412
such that the needlepoint 411a thereof is positioned in the inner
side as compared with the bottom face of the fixed outer cylinder
412 on which the puncture needle opening 412a is provided and also
in the vicinity of the puncture needle opening 412a.
[0345] It is possible by constituting in this manner to protect the
needlepoint 411a of the puncture needle 411. Also, it is possible
to reduce awful feeling of a user, because the needlepoint 411a
becomes hard to be seen.
[0346] The outer diameter of the puncture needle 411 is a little
bit different depending on the use application of the puncture
device 1 or the like, but it is preferable to select it as around
0.05 to 2.5 mm and in particular, preferable to select it as around
0.1 to 1.5 mm.
[0347] There can be cited, for the constituent material of the
puncture needle 411, metal materials such as, for example,
stainless steel, aluminum or aluminum alloy, titanium or titanium
alloy and the like. Also, the puncture needle 411 is manufactured,
for example, by plastic working.
[0348] It is possible for the internal outer cylinder 413 to slide
in the fixed outer cylinder 412 in a longitudinal direction of the
internal outer cylinder 413 by means of the operation of the
plunger 415 and when the internal outer cylinder 413 slides, the
puncture needle 411 firmly fixed to the internal outer cylinder 413
is taken in and out with respect to the fixed outer cylinder 412
through the puncture needle opening 412a.
[0349] For the constituent material of the fixed outer cylinder 412
and the internal outer cylinder 413, there can be cited various
kinds of resins such, for example, as polyvinylchloride,
polyethylene, polypropylene and the like. It should be noted that
the constituent material of the fixed outer cylinder 412 and the
internal outer cylinder 413 is desirable to be substantially
transparent in order to ensure visibility of the inside.
[0350] There is housed, in the internal outer cylinder 413, the
gasket 414 constituted by an elastic material.
[0351] For the constituent material of the gasket 414, although it
is not limited in particular, there can be cited, for example,
various kinds of rubber materials such as natural rubber and
silicone rubber, various kinds of thermoplastic elastomers of
polyurethane series, styrene series and the like or elastic
materials of mixtures thereof and the like.
[0352] In the space surrounded by the gasket 414 and internal outer
cylinder 413, a liquid room 417 is formed and in this liquid room
417, liquid is contained liquid-tightly beforehand.
[0353] There can be cited for the liquid, for example, remedy for
injection or medicinal solution using a macromolecular substance
such as hormone, antibody drug, cytokine, vaccine or the like.
[0354] There is interlinked to the gasket 414 the plunger 415 which
moving-operate the gasket 414 in the internal outer cylinder 413 in
a longitudinal direction.
[0355] A plate-like flange 416 is formed integrally at the rear end
of the plunger 415. The plunger 415 is operated by depressing this
flange 416 with a finger or the like.
[0356] The mounting member 42 is constituted so as to include a
upper surface portion 42a for mounting the injector 41. At the edge
portion in a longitudinal direction of the upper surface portion
42a, there is formed, by being projected toward the adhesive pad 2,
a U-shaped engagement portion 421 to be movable and for being
engaged with the support member 43.
[0357] The support member 43 is constituted by a rectangular
plate-like body having an upper surface portion 43a which contacts
slidably with a mounting member 42. At the edge portion in a
longitudinal direction of the support member 43, there is formed,
by being projected to the horizontal direction with respect to the
adhesive pad 2, an engagement convex portion 431 which has such a
shape to coincide with the U-shaped engagement portion 421 which is
formed on the mounting member 42.
[0358] On the plane on the opposite side of the upper surface
portion 43a of the support member 43, there is formed a lower
surface portion 43b for being fixed with the adhesive pad 2
adhesively. As shown in FIG. 18, the lower surface portion 43b of
the support member 43 is fixed on the adhesive pad 2 by adhesive
agent or the like.
[0359] There can be cited for the constituent material of the
mounting member 42 and the support member 43 various kinds of
resins such as polyethylene, polypropylene or the like and the
mounting member 42 and the support member 43 are manufacture by a
forming process inpouring these resins into a die which has a
predetermined shape or the like.
[0360] It should be noted as the puncture needle moving means 4
that it is allowed to employ such a constitution wherein an
injector having a constitution in which a puncture needle and a
syringe are formed as one body configuration is fixed and retained
on the mounting member 42. In this case, the length of the puncture
needle 411 is adjusted such that the needlepoint 411a of the
puncture needle 411 can puncture the skin uplifted by the skin
deforming means 3 when the mounting member 42 is moved so as to
most approach to the skin deforming means 3.
[0361] Next, it will be explained by using FIG. 19 and FIG. 20 with
respect to usage (operation) of the puncture device 1 of this
exemplified embodiment.
[0362] First, the adhesive pad 2 is mounted on a predetermined
position of the body surface F. At that time, the plane 2a of the
adhesive pad 2 is bonded and fixed on the body surface F by means
of an adhesive film provided on the body surface F side of the
adhesive pad 2.
[0363] In addition, also the outer frame 7x which is fitted with
the through-hole 21 formed on the adhesive pad 2 and is fixed on
the adhesive pad 2 is mounted on the skin. Concurrently, also the
planate member 5y and the handles 6a which are retained by the
outer frame 7x are mounted on the skin.
[0364] At that time, if the puncture device 1 is held down softly
in order to be mounted on the body surface F, the tabular member 5
y will be fixed on the body surface F through the intervention of
the adhesive film 8 owing to the elasticity of the skin.
[0365] Also, as shown in FIG. 19A, the planate member 5y is mounted
on the skin in such a state in which it is inflected upward
slightly. In this manner, by making the tabular member 5y to be
inflected slightly beforehand, it is possible, when the planate
member 5y is inflected by the handles 6a, to inflect the tabular
member 5y upward easily.
[0366] Also, the skin deforming means 3 and the puncture needle
moving means 4 are arranged on the adhesive pad 2 such that the
moving direction of the puncture needle 411 and the center line 5a
of the tabular member 5y coincide with each other.
[0367] Next, the handles 6a projecting on the adhesion pad 2 are
grasped by fingers or the like and are moved so as to approach the
outer frame 7x, and force is to be added to the tabular member 5y.
Thereby, the planate member 5y is inflected so as to be along the
center line 5a of the tabular member 5y.
[0368] At that time, according to the force added by the both the
handles 6a, the body surface F fixed adhesively with the tabular
member 5 y by means of the adhesive film 8 is added with a force
such as being pushed out towards the center line 5a of the tabular
member 5y.
[0369] Further, when the handles 6a are made to approach the outer
frame 7x, the tabular member 5y is further inflected. Also,
concurrently, as shown in FIG. 19B, the body surface F defined by
the portion fixed adhesively with the tabular member 5y is pushed
out and uplifted upward. Thereby, the uplifted body surface F
contacts with the adhesive film 8 provided on the tabular member 5y
and bonded and fixed onto the tabular member 5y.
[0370] More specifically, the skin is fixed on the tabular member 5
y in a state in which the epidermis E including the stratum corneum
SC, the dermis D and the subcutis S are pulled upward
respectively.
[0371] In other words, depending on a fact that the skin is
deformed and uplifted, the position of the plane 2a of the adhesive
pad 2, which is the fixing portion and the position of the skin
fixing plane 5e provided on the planate member 5y become different
in the height direction, a step portion is formed there-between and
the puncture needle 411 is stuck into the step portion thereof.
[0372] At that time, the uplifted body surface F is fixed so as to
become in parallel with the center line 5a of the inflected tabular
member 5y, so that also a portion of the dermis D is fixed in a
state in which it becomes in parallel with the center line 5a.
[0373] Also, the epidermis E, the dermis D and the subcutis S which
are uplifted are fixed in such a state as being along the
inflection of the planate member 5y, respectively. It should be
noted that, the moving distance of the handle 6a which is engaged
with the outer frame 7x to be movable is set such that the height
of the uplifted skin becomes constant.
[0374] Next, the mounting member 42 on which the injector 41 is
fixedly retained is slided to the tip direction.
[0375] Next, the plunger 415 is operated by depressing the flange
416 with a finger or the like and the internal outer cylinder 413
is moved to the tip direction while being slided in the fixed outer
cylinder 412. Thereby, the puncture needle 411 firmly fixed on the
internal outer cylinder 413 is inserted from the puncture needle
opening 412a into the insertion opening 7a provided on the side
surface 71 of the outer frame 7x.
[0376] At that time, the puncture needle 411 of the injector 41 is
stuck in a state coinciding with the center line 5a of the planate
member 5y.
[0377] Also, as shown in FIG. 19C, the puncture needle 411 is moved
in the skin such that it becomes in parallel with the skin fixing
plane 5e and is stuck from the step portion in such a state as
becoming in parallel with the uplifted dermis D.
[0378] The plunger 415 is operated by further depressing the flange
416 with a finger or the like from that state and the gasket 414 is
moved to the tip direction while sliding it together with the
internal outer cylinder 413. Thereby, as shown in FIG. 20A, a
medical agent 50 contained in the liquid room 417 is injected from
the needlepoint 411a of the puncture needle 411 to the dermis
D.
[0379] After the medical agent is injected into the dermis D, the
plunger 415 is operated by pulling the flange 416 with a finger or
the like, the gasket 414 is moved to the rear end direction and the
puncture needle 411 is pulled out from the puncture region P.
[0380] Further, the plunger 415 is moved to the rear end direction
and as shown in FIG. 20B, the puncture needle 411 is housed in the
fixed outer cylinder 412 from the puncture needle opening 412a.
[0381] Next, in this state, the mounting member 42 on which the
injector 41 is fixedly retained is slided to the rear end direction
and it is made to be a state of FIG. 20C.
[0382] In this manner, according to the puncture device 1 of this
exemplified embodiment, it is possible to carry out the puncture by
the puncture needle 411 after the skin including the dermis D is
uplifted by the handles 6a and the skin is fixed by the adhesive
film 8 provided on the planate member 5y. More specifically, the
puncture operation is carried out in a state in which the skin is
uplifted, so that it is possible to stick the puncture needle 411
into the skin (dermis D) certainly and also, it is possible to
inject a medical agent to the dermis D of the skin certainly.
[0383] Also, the puncture needle 411 is stuck so as to become
approximately a parallel state with respect to the dermis D in the
skin, so that the insertion depth of the puncture needle 411 in the
inside of the dermis D becomes long and even in a case in which an
impact or the like is added from the outside, the puncture needle
411 during injecting the medical agent can be prevented from
dropping out from the dermis D.
[0384] Also, the distance from the insertion aperture of the
puncture needle 411, which is formed at a boundary portion between
the epidermis E and the dermis D to the medical agent releasing
aperture which exists at the needlepoint 411a becomes long, so that
the medical agent once injected into the dermis D from the medical
agent releasing aperture can be prevented from leaking from the
insertion aperture to the epidermis E by being flown back
[backward].
[0385] It should be noted that it was explained by one puncture
needle 411 and one puncture needle moving means 4 in the
above-described exemplified embodiment, but a plurality of puncture
needles and a plurality of puncture needle moving means may be
provide instead. In this case, it is preferable to arrange a
plurality of puncture needles so as to become in parallel with
respect to the inflected planate member 5y. By constituting in this
manner, it is possible to make the insertion positions of the
plurality of puncture needles in the skin to be at constant depth
in the skin depth direction.
[0386] In addition, the above-described exemplified embodiments
were explained by using examples in which the puncture needle is
always stuck to the dermis D, but it is possible to use the
puncture device of the present invention also in case of sticking
to a intracutaneous area, a subcutis or further a muscle other than
the dermis.
[0387] Also, the puncture device of the present invention is not
limited by the above-mentioned each exemplified embodiment and
besides that, it goes without saying that various modifications or
changes can be employed for the materials, the constitutions or the
like in the region without departing from the configuration of the
present invention. In particular, it is possible to make the shape,
the structure and the like of the outer frame 7x to be arbitrary
ones which can exert similar functions.
SIXTH EXEMPLIFIED EMBODIMENT
[0388] Next, it will be explained with respect to a sixth
exemplified embodiment of a puncture device of the present
invention.
[0389] FIG. 21 and FIG. 22 are drawings explaining the sixth
exemplified embodiment of the present invention. More
specifically,
[0390] FIG. 21 is a perspective view of a puncture device of the
present invention, FIG. 22 is a side elevational view, FIG. 23 is
an exploded perspective view, FIG. 24 is an enlarged view shown by
enlarging the puncture needle, and FIG. 25 to FIG. 28 are
explanatory diagrams for explaining the usage of the puncture
device shown in FIG. 21.
[0391] As shown in FIG. 21 to FIG. 23, a puncture device 11 is
constituted by being provided with a base member 12, a slide member
13 supported by the base member 12 to be movable slidably, a
puncture needle 14 mounted on the this slide member 13, an adhesive
film 15 showing one embodiment of an adhesion member for fixing the
base member 12 on the body surface F and the like. It should be
noted that there are arranged, on the lower side of the body
surface F on which the base member 12 is fixed, a stratum corneum
SC, an epidermis E including the stratum corneum SC, a dermis D and
a subcutis S in the form of laminae (see FIG. 25, etc.).
[0392] The base member 12 of the puncture device 11 is constituted
by a positioning portion 17, a fixing portion 18, a pair of hinge
portions 19, 19 interlinking the fixing portion 18 to the
positioning portion 17 to be revolvable and the like. The
positioning portion 17 of the base member 12 is formed as
approximately a rectangular plate body and the side surface of one
short side is interlinked to the fixing portion 18 through the pair
of hinge portions 19, 19. The lower surface of this positioning
portion 17 is made to be a skin fixing plane 17a for fixing the
positioning portion 17 on the body surface F by being appressed
thereto.
[0393] Also, there are provided on both the side surfaces of the
long sides of the positioning portion 17 with notches 112, 112 from
the edge portion of the hinge portion 19 side until an intermediate
portion in the longitudinal direction thereof and thereby, guide
rails 113, 113 showing one embodiment of first guide means are
formed. These guide rails 113, 113 are engaged with engagement
grooves 134a, 134a to be described hereinafter of the slide member
13, respectively. Also, there are provided at the edge portions on
the opposite side with respect to the hinge portions 19 of the
respective notches 112, 112 with stopper protrusion portions 114,
114 for latching the sliding motion of the slide member 13,
respectively (only one side is shown in FIG. 21 etc.).
[0394] The fixing portion 18 of the base member 12 is formed by
approximately a rectangular plate body and is constituted by a main
body plate 116 in which the short side thereof is set to have
length equivalent to the length on the short side of the
positioning portion 17, a latch piece 117 which is continuous with
one side of this main body plate 116 and the like. The lower
surface of the main body plate 116 of the fixing portion 18 is a
plane for fixing the fixing portion 18 on the body surface F by
being appressed thereto and is made to be a contact surface 121.
The upper surface of the main body plate 116 is formed with a slide
guide groove 122 showing one embodiment of second guide means which
is extended approximately at the central portion in the width
direction along the longitudinal direction. This slide guide groove
122 is engaged with a needle retaining portion 132 to be described
hereinafter of the slide member 13 slidably.
[0395] The puncture needle moving means retaining the puncture
needle 13 to be movable is constituted by the slide member 13 and
the fixing portion 18. Also, the skin deforming means for deforming
the skin is constituted by the base member 12, the positioning
portion 15 and the hinge portion 19.
[0396] Further, on one short side of the main body plate 116 there
is provided with a pair of interlink portions 123, 123 projecting
upward from both the sides of the slide guide groove 122. There are
formed on the pair of interlink portions 123, 123 with inclined
surfaces 123a, 123a inclined so as to become smaller sequentially
toward the tip side and the tip portions thereof are interlinked to
the lower portion of the side surface of the positioning portion 17
through the pair of hinge portions 19, 19. Thereby, there are
formed between the pair of interlink portions 123, 123 of the main
body plate 116 with an opening window 125 showing one embodiment of
a through-hole to be passed through by the puncture needle 14
mounted on the slide member 13. Then, the side surface on the pair
of interlink portions 123, 123 side of the main body plate 116 is
made to be a depressing surface 124 for uplifting the skin.
[0397] The latch piece 117 of the fixing portion 18 is composed of
a rising portion 127 projecting approximately perpendicularly by
being continuous with the main body plate 116 and a flange portion
128 which is developed approximately perpendicularly from this
rising portion 127 and faces to the main body plate 116. The rising
portion 127 of this latch piece 117 is contacted with the needle
retaining portion 132 of the slide member 13. Also, there is
provided on the surface of the flange portion 128 facing to the
upper surface of the main body plate 116 with a latch protrusion
portion 128a and this latch protrusion portion 128a is engaged with
a latch concave portion 138 to be described hereinafter of the
needle retaining portion 132.
[0398] Also, the hinge portions 19, 19 of the base member 12 is set
to have lower stiffness as compared with the positioning portion 17
or the fixing portion 18. Depending on this configuration, the
fixing portion 18 is made to be revolvable in the angular range of
approximately 90 degree from approximately a perpendicular state
with respect to the positioning portion 17 (state shown in FIG. 22
etc.) until approximately a parallel state with respect to the
positioning portion 17 (state shown in FIG. 23 etc.).
[0399] It is possible for the material of such a base member 12 to
cite, for example, an ABS (acrylonitrile-butadiene-styrene resin).
However, the material of the base member 12 is not limited by the
ABS and it is needless to say that synthetic resins of engineering
plastic or others can be applied thereto and it is also possible to
use metals such as aluminum alloy or the like other than the
synthetic resins.
[0400] As shown in FIG. 22, FIG. 23 and the like, the adhesive film
15 for bonding and fixing the base member 12 on the body surface F
is glued on the lower surface of the positioning portion 17 of the
base member 12. The length in the width direction of this adhesive
film 15 is set to be longer than the length in the width direction
of the base member 12, and the length in the longitudinal direction
thereof is set to be a length corresponding to the length from the
midway portion of the positioning portion 17 until the midway
portion of the contact surface 121 constituted by a plane which is
formed at the fixing portion 18 by way of the hinge portions 19,
19. Then, the portion which does not correspond to the positioning
portion 17 spreads in a skirt shape.
[0401] It should be noted for the adhesive film 15 relating to the
present invention that it is not limited by the shape as mentioned
above and it may be constituted such that the length in the width
direction is set equivalently with the length in the width
direction of the base member 12 and as shown in FIG. 22, the whole
surface which reaches from the midway portion of the contact
surface 121 of the fixing portion 18 to the midway portion of the
positioning portion 17 through the hinge portions 19, 19 is to be
glued on the base member 12 beforehand.
[0402] It is possible for the material of the adhesive film to cite
polyethylene terephthalate (PET) and polyethylene which do not
expand or contract and the like, but it is not limited by this and
it is possible to use various kinds of materials such as
polyurethane and others which are used as this kind of adhesive
film. Also, it is preferable for the thickness of the adhesive film
15 to be around 1 micron to 30 microns, but it should be noted that
even an adhesive film having thickness of more than 30 microns can
be applied thereto.
[0403] The slide member 13 showing one embodiment of retaining
means for retaining the puncture needle 14 is constituted, as shown
in FIG. 23 etc., by being provided with a slide plate 131 forming
approximately a rectangular plate body, a needle retaining portion
132 which is continuous with one side of this slide plate 131 and
the like. The slide plate 131 of the slide member 13 is provided
with a pair of side surface pieces 134, 134 which are continuous
with the long sides respectively and project to the lower side and
engagement grooves 134a, 134a are formed on the mutually facing
surfaces of these side surface pieces 134, 134.
[0404] Each of the engagement grooves 134a, 134a of the pair of
side surface pieces 134, 134 are slidably engaged with each of the
guide rails 113, 113 of the base member 12. Also, the pair of side
surface pieces 134, 134 are provided with stopper concave portions
which are not shown respectively at the positions corresponding to
the respective stopper protrusion portions 114, 114 of the base
member 12 and the sliding motion of the slide member 13 is latched
by engaging the respective stopper protrusion portions 114, 114
with these stopper concave portions.
[0405] Further, the slide plate 131 of the slide member 13 is
provided with an operation protrusion portion 136 which is
continuous with the one short side and projects upward. This
operation protrusion portion 136 is provided for making it easy to
be operated by hooking a finger thereon when slide-operating the
slide member 13. Then, the needle retaining portion 132 is arranged
on the opposite side with respect to the operation protrusion
portion 136 of the of the slide plate 131.
[0406] The needle retaining portion 132 of the slide member 13 is
made to be approximately a quadrangular hollow housing and is
constituted by an upper surface 132a forming the same surface as
the upper surface of the slide plate 131, a front face 132b on
which the puncture needle 14 is mounted, a back face 132c on the
opposite side of the front face 132b, a right side surface 132d
forming a side surface on the right side by seeing the front face
132b from the tip side of the slide plate 131, and a left side
surface and a bottom face which do not appear in the figure. Then,
by engaging the bottom face side of the needle retaining portion
132 with the slide guide groove 122 of the base member 12 slidably,
the slide member 13 is supported on the base member 12 to be
slide-movable.
[0407] There is provided on the upper surface 132a of the needle
retaining portion 132 with a latch concave portion 138 extended in
the direction parallel with the width direction of the slide plate
131. The slide moving of the slide member 13 is latched by engaging
the latch protrusion portion 128a of the base member 12 with this
latch concave portion 138. More specifically, the locking means for
locking the movement of the slide member 13 which is the retaining
means is constituted by the latch concave portion 138 provided on
the upper surface 132a of the needle retaining portion 132, the
latch protrusion portion 128a of the fixing portion 18, the stopper
protrusion portions 114, 114 of the positioning portion 17 and
respective stopper concave portions which are provided, although
not shown, on the side surface piece 134 of the slide plate
131.
[0408] The puncture needle 14 mounted on the front face 132b of the
needle retaining portion 132 forms, as shown in FIG. 24, a hollow
needle and it is arranged such that the axis center thereof
coincides with the direction to which the slide plate 131 is slided
along the side surface pieces 134, 134. With respect to the
diameter and the length of this puncture needle 14, although not
being limited in particular, it is preferable for the diameter
thereof to be around 0.1 mm to 3 mm and it is preferable for the
length thereof to be around 2 mm to 20 mm. Also, it is possible for
the material of the puncture needle 14 to cite, for example,
stainless steel, but it is not limited by this and it is possible
to use aluminum, aluminum alloy, titanium, titanium alloy or other
metals. A blade surface 14a, as shown in FIG. 24, is formed at the
tip of the puncture needle 14. The blade surface 14a is faced to a
direction horizontally perpendicular to the moving direction of the
slide member (retaining means) 13. According to the configuration
that the blade surface 14a is directed to the aforesaid direction,
when the puncture needle 14 is made to go into the skin, the blade
edge of the puncture needle 14 is prevented from being bended to
the depth direction of the skin and it is possible to place it at
an accurate position.
[0409] Further, a tube 139 is mounted on the right side surface
132d of the needle retaining portion 132. One terminal of the tube
139 is inserted into the inside thereof from a through-hole
provided on the right side surface 132d of the needle retaining
portion 132 and is communicated with the puncture needle 14 mounted
on the front face 132b in the inside thereof. Also, the other
terminal of the tube 139 is, although not shown, made to
communicate with an injection device such as an injector, a liquid
transmission pump or the like.
[0410] It is possible for the material of the slide member 13 to
cite, for example, an ABS (acrylonitrile-butadiene-styrene resin).
However, the material of the slide member 13 is not limited by the
ABS and synthetic resins of engineering plastic or others can be
applied thereto.
[0411] According to the puncture device 11 having such a
constitution, it is possible, for example, in a way described as
follows to stick the puncture needle 14 into the dermis D which
constitutes a portion of the skin and to inject liquid of medicinal
solution or the like thereto.
[0412] The state before the skin is punctured, more specifically,
the state of the puncture device 11 before being used is, as shown
in FIG. 22, made to be a state in which the fixing portion 18 is
approximately perpendicular with respect to the positioning portion
17. In this state, the needle retaining portion 132 of the slide
member 13 is engaged with the engagement piece 117 of the fixing
portion 18. At that time, the back face 132c of the needle
retaining portion 132 is contacted to the rising portion 127 of the
engagement piece 117 and at the same time, the latch concave
portion 138 of the needle retaining portion 132 is engaged with the
latch protrusion portion 128a of the engagement piece 117, so that
the slide-movement of the slide member 13 is latched.
[0413] The fixing portion 18 of such a puncture device 11 is
grasped by fingers, the positioning portion 17 and the depressing
surface 124 of the fixing portion 18 are pressure-attached onto the
body surface F which is the most outer framework of the skin and
are adhesively fixed thereon by the adhesive film 15. At that time,
the puncture needle 14 mounted on the slide member 13 is positioned
between the slide plate 131 and the main body plate 116 of the
fixing portion 18, so that it is possible to prevent the finger
grasping the puncture device 11 from touching the puncture needle
14 or to prevent the puncture needle 14 from puncturing the finger
accidentally and it is possible to maintain the puncture needle 14
in a clean state.
[0414] Next, as shown in FIG. 26, the fixing portion 18 is turned
by approximately 90 degree and the skin bonded to the positioning
portion 17 is uplifted. More specifically, the fixing portion 18 is
turned by approximately 90 degree and by obtaining a state in which
the depressing surface 124 is made to be orthogonal with respect to
the positioning portion 17, the skin bonded to the depressing
surface 124 is depressed and the skin bonded to the positioning
portion 17 is uplifted. Thereby, the epidermis E including the
stratum corneum SC, the dermis D and the subcutis S are pulled
upward respectively and the skin is uplifted to the vertical
direction with respect to the body surface F.
[0415] Concurrently with this, the contact surface 121 of the
fixing portion 18 is bonded and fixed on the body surface F by
means of the adhesive film 15. Thereby, depending on a fact that
the skin is deformed and uplifted, the position of the contact
surface 121 provided on the fixing portion 18 and the position of
the skin fixing plane 17a formed on the positioning portion 17
become different in the height direction and a step is formed
between the skin bonded to the positioning portion 17 and the skin
bonded or appressed to the contact surface 121 of the fixing
portion 18. Then, by relatively setting the height of the
depressing surface 124 and the mounting position of the puncture
needle 14 or the like, the height of the dermis D of the skin
bonded to the positioning portion 17 and the height of the puncture
needle 14 are made to coincide with each other.
[0416] Subsequently, as shown in FIG. 27, a finger is hooked on the
operation protrusion portion 136 and the slide member 13 is
depressed to the positioning portion 17 side. Thereby, the latch
concave portion 138 of the needle retaining portion 132 is
unfastened from the latch protrusion portion 128a of the engagement
piece 17 and it is possible to slide the slide member 13 to the
positioning portion 17 side. When the slide member 13 is slided,
first, the respective engagement grooves 134a, 134a provided on the
pair of side surface pieces 134, 134 of the slide member 13 are
engaged with the pair of guide rails 113, 113 of the positioning
portion 17.
[0417] At that time, the slide member 13 is slided along the slide
guide groove 122 of the fixing portion 18 by means of the needle
retaining portion 132, so that it is possible to easily engage
respective engagement grooves 134a, 134a of the slide member 13
with the pair of guide rails 113, 113 of the positioning portion
17. In this manner, the slide member 13 is guided by the slide
guide groove 122 of the fixing portion 18 and the pair of guide
rails 113, 113 of the positioning portion 17 and is slided to the
positioning portion 17 side.
[0418] Thereafter, the slide member 13 is further slided and, as
shown in FIG. 28, the front face 132b of the retaining portion 132
is contacted to the positioning portion 17. Thereby, the puncture
needle 14 is moved approximately in parallel with the contact
surface 121, passes through the opening window 125 (see FIG. 23) of
the fixing portion 18, which is provided at the step portion and is
stuck concurrently from the body surface F facing to the opening
window 125 thereof to the dermis D, and the puncture operation by
means of the puncture device 11 is terminated.
[0419] At that time, the puncture needle 14 is stuck approximately
perpendicularly with respect to the body surface F facing to the
opening window 125, so that the intrusion direction of the blade
edge is never deviated to the depth direction of the skin and it is
possible to carry out the puncture to the dermis D certainly.
Further, the adhesive film 15 is glued also on the body surface F
facing to the opening window 125 of the fixing portion 18, so that
it is possible when sticking the puncture needle 14 to prevent or
repress the whole skin from being sunk elastically and it is
possible to stick the puncture needle 14 into the skin easily.
[0420] Also, when the front face 132b of the needle retaining
portion 132 is contacted to the positioning portion 17, the
respective stopper concave portions which are provided on the pair
of side surface piece 134, 134 of the slide member 13 although not
shown are engaged with the stopper protrusion portions 114, 114 of
the positioning portion 17. For that reason, it is possible to
latch the slide-movement to the fixing portion 18 side of the slide
member 13. Further, the front face 132b of the needle retaining
portion 132 is contacted with the positioning portion 17, so that
it is possible to prevent the fixing portion 18 from jumping up.
Thereby, even if the finger is released, it is possible for the
puncture device 11 to be retained in a state in which the puncture
needle 14 is stuck in the dermis D of the uplifted skin (state
shown in FIG. 28) and it is possible to prevent the puncture needle
14 from dropping out abruptly.
[0421] When the puncture operation by means of the puncture device
11 is terminated, liquid such as medicinal solution or the like is
sent to the tube 139 from the injection device such as an injector,
a liquid transmission pump or the like which is not shown and is
injected into the dermis D through the puncture needle 14.
Thereafter, when it is desired to detach the puncture device 11,
first, fingers are hooked on the operation protrusion portion 136
and the slide member 13 is to be depressed to the fixing portion 18
side. Thereby, the respective stopper concave portions of the slide
member 13 are unfastened from the stopper protrusion portions 114,
114 of the positioning portion 17 and the slide member 13 becomes
slide-movable to the fixing portion 18 side.
[0422] Next, the slide member 13 is slided and the back face 132c
of the needle retaining portion 132 is contacted with the rising
portion 127 of the latch piece 117. Thereby, the puncture needle 14
pulled out from the skin. At that time, the latch concave portion
138 of the needle retaining portion 132 is engaged with the latch
protrusion portion 128a of the engagement piece 117, so that the
slide-movement of the slide member 13 is latched.
[0423] Thereafter, the base member 12 is exfoliated from the body
surface F and the detaching of the puncture device 11 is completed.
At that time, it is possible to exfoliate it easily if a portion on
which the adhesive film 15 of the positioning portion 17 is not
mounted is pinched and lifted. Also, the slide member 13 retaining
the puncture needle 14 is latched for the slide-movement, so that
it is possible to prevent an accidental needlestick, an infection
caused by that accidental needlestick or the like.
[0424] As explained above, according to the puncture device of this
exemplified embodiment, in case of, for example, puncturing the
dermis D, it is possible to lift the dermis D of the skin to an
equivalent height as that of the puncture needle by turning the
fixing portion in a state in which the positioning portion is
adhesively fixed onto the body surface F and by uplifting the skin
and it is possible to make the direction to which the axis center
of the puncture needle thereof is extended and the direction to
which the dermis D layer is extended to be approximately in
parallel with each other.
[0425] As a result thereof, it becomes possible to lengthen the
distance from the medical agent releasing aperture which exists at
the needlepoint of the puncture needle until the epidermis E and
the body surface F, so that it is possible to prevent the medical
agent injected from the medical agent releasing aperture to the
dermis D from flowing back [backward] and permeating the epidermis
E or from leaking to the outside of the body surface F.
Accordingly, it is possible to inject the medical agent into the
dermis D certainly.
[0426] It should be noted that the above-described exemplified
embodiments were explained by using examples in which the puncture
needle is always stuck to the dermis D, but it is possible to use
the puncture device of the present invention also in case of
sticking to an intracutaneous area, a subcutis or further a muscle
other than the dermis.
[0427] It should be noted for the skin deforming means of the
present invention that it is not limited by the aforesaid
exemplified embodiments and it is possible to cite configurations
in which a predetermined portion of the skin is gathered and lifted
by pushing the both sides thereof, the predetermined portion of the
skin is hooked and lifted and the like.
[0428] Also, the puncture device of the present invention is not
limited by the above-mentioned each exemplified embodiment and
besides that, it is needless to say that various modifications or
changes can be employed for the materials, the constitutions or the
like in the region without departing from the configuration of the
present invention.
[0429] Hereinafter, it will be explained with respect to modes for
practicing an administration device of the present invention with
reference to drawings, but the present invention is not limited by
the following modes.
[0430] FIG. 21 is an explanatory diagram for explaining a first
exemplified embodiment of an administration device of the present
invention. FIG. 22 is a side elevational view of a puncture device
constituting a portion of the administration device shown in FIG.
21. FIG. 23 is an exploded perspective view of the puncture device.
FIG. 24 is an enlarged view showing the puncture needle of the
puncture device by being enlarged. FIGS. 25 to 28 are explanatory
diagrams for explaining the usage of the puncture device. FIG. 29
is an explanatory diagram in which a main portion of the puncture
device shown in FIG. 21 is enlarged. FIG. 30 is an explanatory
diagram showing another example of a mounting position of an
adhesion member relating to the puncture device. FIG. 31 indicates
a measured result of blood concentrations of a case in which
insulin is administered to the dermis by using the administration
device of the present invention and is a diagram showing a time
curve of blood concentration.
[0431] As shown in FIG. 21 and the like, an administration device
501 showing a first exemplified embodiment of an administration
device of the present invention is constituted by being provided
with a puncture device 11 and an injection device (not shown) in
communication with one puncture needle 14 of this puncture device
11.
[0432] As shown in FIG. 21 to FIG. 23, the puncture device 11 is
constituted by being provided with a base member 12, a slide member
13 supported by the base member 12 slidably, an adhesive film 15
showing one embodiment of an adhesion member for fixing the base
member 12 on the body surface F and the like. It should be noted
that there are arranged, on the lower side of the body surface F on
which the base member 12 is fixed, a stratum corneum SC, an
epidermis E including the stratum corneum SC, a dermis D and a
subcutis S in the form of laminae (see FIG. 25, etc.).
[0433] The base member 12 of the puncture device 11 is constituted
by a positioning portion 17, a fixing portion 18, a pair of hinge
portions 19, 19 interlinking the fixing portion 18 to the
positioning portion 17 to be revolvable and the like. The
positioning portion 17 of the base member 12 forms approximately a
rectangular plate body in which one side surface of the short sides
thereof is interlinked to the fixing portion 18 through the pair of
hinge portion 19, 19. The lower surface of this positioning portion
17 is made to be a plane for firmly attaching and fixing the
positioning portion 17 on to the body surface F.
[0434] Also, there are provided on both the side surfaces of the
long sides of the positioning portion 17 with notches 112, 112 from
the edge portion of the hinge portion 19 side until an intermediate
portion in the longitudinal direction thereof and thereby, guide
rails 113, 113 showing one embodiment of first guide means are
formed. These guide rails 113, 113 are engaged with engagement
grooves 134a, 134a to be described hereinafter of the slide member
13, respectively. Also, there are provided at the edge portions on
the opposite side with respect to the hinge portions 19 of the
respective notches 112, 112 with stopper protrusion portions 114,
114 for latching the sliding motion of the slide member 13,
respectively (only one side is shown in FIG. 21 etc.).
[0435] As shown in FIG. 23, the fixing portion 18 of the base
member 12 is formed by approximately a rectangular plate body and
is constituted by a main body plate 116 in which the short side
thereof is set to have length equivalent to the length on the short
side of the positioning portion 17, a latch piece 117 which is
continuous with one side of this main body plate 116 and the like.
The lower surface of the main body plate 116 is a plane for fixing
the fixing portion 18 on the body surface F by being appressed
thereto and is made to be a contact surface 121. The upper surface
of the main body plate 116 is formed with a slide guide groove 122
showing one embodiment of second guide means which is extended
approximately at the central portion in the width direction along
the longitudinal direction. This slide guide groove 122 is engaged
with a needle retaining portion 132 to be described hereinafter of
the slide member 13 slidably.
[0436] Further, on one short side of the main body plate 116 it is
provided with a pair of interlink portions 123, 123 projecting
upward from both the sides of the slide guide groove 122. There are
formed on the pair of interlink portions 123, 123 with inclined
surfaces 123a, 123a inclined so as to become taller sequentially
toward the tip side and those tip portions are interlinked to the
lower portion of the side surface of the positioning portion 17
through the pair of hinge portions 19, 19. Thereby, there are
formed between the pair of interlink portions 123, 123 of the main
body plate 116 with an opening window 125 showing one embodiment of
a through-hole to be passed through by the puncture needle 14
mounted on the slide member 13. Then, the side surface on the pair
of interlink portions 123, 123 side of the main body plate 116 is
made to be a depressing surface 124 for uplifting the skin.
[0437] The latch piece 117 of the fixing portion 18 is composed of
a rising portion 127 projecting approximately perpendicularly by
being continuous with the main body plate 116 and a flange portion
128 which is developed approximately perpendicularly from this
rising portion 127 and faces to the main body plate 116. The rising
portion 127 of this latch piece 117 is contacted with the needle
retaining portion 132 of the slide member 13. Also, there is
provided on the surface of the flange portion 128 facing to the
upper surface of the main body plate 116 with a latch protrusion
portion 128a and this latch protrusion portion 128a is engaged with
a latch cocave portion 138 to be described hereinafter of the
needle retaining portion 132.
[0438] The hinge portions 19, 19 of the base member 12 is set to
have lower stiffness as compared with the positioning portion 17 or
the fixing portion 18. Depending on this configuration, the fixing
portion 18 is made to be revolvable in the angular range of
approximately 90 degree from approximately a perpendicular state
with respect to the positioning portion 17 (state shown in FIG. 22
etc.) until approximately a parallel state with respect to the
positioning portion 17 (state shown in FIG. 23 etc.).
[0439] It is possible for the material of such a base member 12 to
cite, for example, an ABS (acrylonitrile-butadiene-styrene resin).
However, the material of the base member 12 is not limited by the
ABS and it is needless to say that synthetic resins of engineering
plastic or others can be applied thereto and it is also possible to
use metals such as aluminum alloy or the like other than the
synthetic resins.
[0440] As shown in FIG. 22, FIG. 23 and the like, the adhesive film
15 for bonding and fixing the base member 12 on the body surface F
is glued on the lower surface of the positioning portion 17 of the
base member 12. The length in the width direction of this adhesive
film 15 is set to be longer than the length in the width direction
of the base member 12, and the length in the longitudinal direction
thereof is set to be a length corresponding to the length from the
midway portion of the positioning portion 17 until the midway
portion of the contact surface 121 of the fixing portion 18 by way
of the hinge portions 19, 19. Then, the portion which does not
correspond to the positioning portion 17 spreads in a skirt
shape.
[0441] It should be noted for the adhesive film relating to the
present invention that it is not limited by the shape of the
above-mentioned adhesive film 15. For example, as shown in FIG. 30,
it is also possible to use an adhesive film 15a in which the length
of the width direction is set to be equivalent with the length of
the width direction of the base member 12. Then, it is allowed for
such an adhesive film 15a to glue the whole surface thereof on the
base member 12 beforehand. At that time, the adhesive film 15a is
glued so as to reach the midway portion of the contact surface 121
of the fixing portion 18 from the midway portion of the positioning
portion 17 by way of the hinge portions 19, 19.
[0442] It is possible for the material of the adhesive film to cite
polyethylene terephthalate (PET) and polyethylene which do not
expand or contract and the like, but it is not limited by this and
it is possible to use various kinds of materials such as
polyurethane and others which are used as this kind of adhesive
film. Also, it is preferable for the thickness of the adhesive film
15 to be around 1 micron to 30 microns, but it should be noted that
even an adhesive film having thickness of more than 30 microns can
be applied thereto.
[0443] The slide member 13 showing one embodiment of retaining
means for retaining the puncture needle 14 is constituted, as shown
in FIG. 23 and the like, by being provided with a slide plate 131
forming approximately a rectangular plate body, a needle retaining
portion 132 which is continuous with one side of this slide plate
131 and the like. The slide plate 131 of the slide member 13 is
provided with a pair of side surface pieces 134, 134 which are
continuous with the long sides respectively and project to the
lower side and engagement grooves 134a, 134a are formed
respectively on the mutually facing surfaces of these side surface
pieces 134, 134.
[0444] Each of the engagement grooves 134a, 134a of the pair of
side surface pieces 134, 134 are slidably engaged with each of the
guide rails 113, 113 of the base member 12. Also, the pair of side
surface pieces 134, 134 are provided with stopper concave portions
which are not shown respectively at the positions corresponding to
the respective stopper protrusion portions 114, 114 of the base
member 12. More specifically, the sliding motion of the slide
member 13 is latched by engaging the respective stopper concave
portions which are not shown with the respective stopper protrusion
portions 114, 114 of the base member 12.
[0445] Further, the slide plate 131 of the slide member 13 is
provided with an operation protrusion portion 136 which is
continuous with the one short side and projects upward. This
operation protrusion portion 136 is provided for making it easy to
be operated by hooking a finger thereon when slide-operating the
slide member 13. Then, the needle retaining portion 132 is arranged
on the opposite side with respect to the operation protrusion
portion 136 of the of the slide plate 131.
[0446] The needle retaining portion 132 of the slide member 13 is
made to be approximately a quadrangular hollow housing and is
constituted by an upper surface 132a forming the same surface as
the upper surface of the slide plate 131, a front face 132b on
which the puncture needle 14 is mounted, a back face 132c on the
opposite side of the front face 132b, a right side surface 132d
forming a side surface on the right side by seeing the front face
132b from the tip side of the slide plate 131, and a left side
surface and a bottom face which do not appear in the figure. Then,
by engaging the bottom face side of the needle retaining portion
132 with the slide guide groove 122 of the base member 12 slidably,
the slide member 13 is supported on the base member 12 to be
slidable.
[0447] There is provided on the upper surface 132a of the needle
retaining portion 132 with a latch concave portion 138 extended in
the direction parallel with the width direction of the slide plate
131. It is constituted such that the sliding of the slide member 13
is latched by engaging this latch concave portion 138 with the
latch protrusion portion 128a of the base member 12. More
specifically, the locking means for locking the movement of the
slide member 13 is constituted by the latch concave portion 138 of
the needle retaining portion 132, the latch protrusion portion 128a
of the fixing portion 18, the stopper protrusion portions 114, 114
of the positioning portion 17 and respective stopper concave
portions, which are not shown, of the slide plate 131.
[0448] The puncture needle 14 mounted on the front face 132b of the
needle retaining portion 132 forms, as shown in FIG. 24, a hollow
needle. This puncture needle 14 is arranged such that the axis
center thereof coincides with the direction to which the needle
retaining portion 132 moves. With respect to the diameter and the
length of the puncture needle 14, although not being limited in
particular, it is preferable for the diameter thereof to be around
0.1 mm to 3 mm and it is preferable for the length thereof to be
around 2 mm to 20 mm. Also, it is possible for the material of the
puncture needle 14 to cite, for example, stainless steel, but it is
not limited by this and it is possible to use aluminum, aluminum
alloy, titanium, titanium alloy or other metals.
[0449] A blade surface 14a, as shown in FIG. 24, is formed at the
tip of the puncture needle 14. The blade surface 14a is faced to a
direction horizontally perpendicular to the moving direction of the
slide member 13. In this manner, by directing the blade surface 14a
of the puncture needle 14 to the aforesaid direction, when the
puncture needle 14 is made to go into the skin, the blade edge of
the puncture needle 14 is prevented from being bended to the depth
direction of the skin and it is possible to place it at an accurate
position.
[0450] Further, a tube 139 is mounted on the right side surface
132d of the needle retaining portion 132. One terminal of the tube
139 is inserted into the inside thereof from a through-hole
provided on the right side surface 132d of the needle retaining
portion 132 and is communicated with the puncture needle 14 mounted
on the front face 132b in the inside thereof. Also, the other
terminal of the tube 139 is made to communicate with an injection
device which is not shown, such as an injector (syringe), a liquid
transmission pump or the like.
[0451] It is possible for the material of the slide member 13 to
cite, for example, an ABS (acrylonitrile-butadiene-styrene resin).
However, the material of the slide member 13 is not limited by the
ABS and synthetic resins of engineering plastic or others can be
applied thereto.
[0452] According to the administration device 501 having such a
constitution, it is possible, for example, in a way described as
follows to stick the puncture needle 14 into the dermis D which
constitutes a portion of the skin and to administer a substance of
a medicinal solution, an immune cell or the like thereto.
[0453] As shown in FIG. 22, the puncture device 11 before the use
of administration device 501 (before the skin is punctured) is made
to be in a state in which the fixing portion 18 is approximately
perpendicular with respect to the positioning portion 17. In this
state, the latch concave portion 138 provided on the needle
retaining portion 132 of the slide member 13 is engaged with the
latch protrusion portion 128a of the latch piece 117, so that the
slide-movement of the slide member 13 is latched.
[0454] In order to stick the puncture needle 14 into the dermis D,
first, as shown in FIG. 25, the fixing portion 18 of the puncture
device 11 is grasped by fingers, the depressing surface 124 of the
fixing portion 18 and the positioning portion 17 are
pressure-attached onto the body surface F which is the most outer
framework of the skin. Thereby, the depressing surface 124 of the
fixing portion 18 and the positioning portion 17 are bonded and
fixed on the body surface F by means of the adhesive film 15. At
that time, the puncture needle 14 mounted on the slide member 13 is
positioned between the slide plate 131 and the main body plate 116
of the fixing portion 18. Therefore, it is possible to prevent the
finger grasping the puncture device 11 from touching the puncture
needle 14 or to prevent the puncture needle 14 from puncturing the
finger accidentally and it is possible to maintain the puncture
needle 14 in a clean state.
[0455] Next, as shown in FIG. 26, the fixing portion 18 is turned
by approximately 90 degree and the skin bonded to the positioning
portion 17 is uplifted. More specifically, the fixing portion 18 is
turned by approximately 90 degree and by obtaining a state in which
the depressing surface 124 is made to be orthogonal with respect to
the positioning portion 17, the skin bonded to the depressing
surface 124 is depressed and the skin bonded to the positioning
portion 17 is uplifted. Thereby, the epidermis E including the
stratum corneum SC, the dermis D and the subcutis S are pulled
upward respectively and the skin is uplifted to the vertical
direction with respect to the body surface F.
[0456] Concurrently with this, the contact surface 121 of the
fixing portion 18 is bonded and fixed on the body surface F by
means of the adhesive film 15. Thereby, a step is formed between
the skin bonded to the positioning portion 17 and the skin bonded
or appressed to the contact surface 121 of the fixing portion 18.
At that time, the height of the depressing surface 124 and the
mounting position of the puncture needle 14 are set relatively, so
that it is constituted such that the height of the dermis D of the
skin bonded to the positioning portion 17 and the height of the
puncture needle 14 are to coincide with each other.
[0457] In this exemplified embodiment, as shown in FIG. 29, the
height X of the depressing surface 124 is set to be approximately 3
mm and at the same time, the distance Y of the height direction
from the tip of the depressing surface 124 until the axis center of
the puncture needle 14 is set to be approximately 1 mm. Thereby, it
is possible to make the height of the puncture needle 14 to
coincide with the dermis D having width of around 1 mm to 2 mm
which is positioned under the epidermis having width of around 0.06
mm to 0.1 mm from the body surface F bonded to the positioning
portion 17. However, the height X of the depressing surface 124 and
the distance Y from the tip portion of the depressing surface 124
until the puncture needle 14 relating to the present invention are
not limited by the above-mentioned values and it is possible to
make a relative setting such that the height of the dermis D when
the skin is uplifted and the height of the puncture needle 14 are
to coincide with each other.
[0458] Subsequently, as shown in FIG. 27, a finger is hooked on the
operation protrusion portion 136 and the slide member 13 is
depressed to the positioning portion 17 side. Thereby, the latch
concave portion 138 of the needle retaining portion 132 is
unfastened from the latch protrusion portion 128a of the engagement
piece 117 and it is possible to slide the slide member 13 to the
positioning portion 17 side. When the slide member 13 is slided,
first, the respective engagement grooves 134a, 134a provided on the
pair of side surface pieces 134, 134 of the slide member 13 are
engaged with the pair of guide rails 113, 113 of the positioning
portion 17.
[0459] At that time, the slide member 13 is slided along the slide
guide groove 122 of the fixing portion 18 by means of the needle
retaining portion 132, so that it is possible to easily engage
respective engagement grooves 134a, 134a of the slide member 13
with the pair of guide rails 113, 113 of the positioning portion
17. In this manner, the slide member 13 is guided by the slide
guide groove 122 of the fixing portion 18 and the pair of guide
rails 113, 113 of the positioning portion 17 and is slided to the
positioning portion 17 side.
[0460] Thereafter, the slide member 13 is further slided and, as
shown in FIG. 28, the front face 132b of the needle retaining
portion 132 is contacted to the positioning portion 17. The
puncture needle 14 moves a distance of 1 to 15 mm, preferably, 3 to
10 mm by being slided the slide member 13. In this case, the
puncture needle 14 passes through the opening window 125 (see FIG.
23) of the fixing portion 18 and is stuck from the body surface F
facing to the opening window 125 thereof to the dermis D. More
specifically, the puncture needle 14 has a portion to go into in
parallel with the dermis layer. Thereby, the puncture operation by
the puncture device 11 is finalized.
[0461] At that time, the puncture needle 14 is stuck approximately
perpendicularly with respect to the body surface F facing to the
opening window 125, so that the intrusion direction of the blade
edge is never deviated to the depth direction of the skin and it is
possible to carry out the puncture to the dermis D certainly.
Further, the adhesive film 15 is glued also on the body surface F
facing to the opening window 125 of the fixing portion 18, so that
it is possible when sticking the puncture needle 14 to prevent or
repress the whole skin from being sunk elastically and it is
possible to stick the puncture needle 14 into the skin easily.
[0462] Also, when the front face 132b of the needle retaining
portion 132 is contacted to the positioning portion 17, the
respective stopper concave portions which are provided on the pair
of side surface piece 134, 134 of the slide member 13 although not
shown are engaged with the stopper protrusion portions 114, 114 of
the positioning portion 17. Thereby, it is possible to latch the
sliding to the fixing portion 18 side of the slide member 13.
Further, the front face 132b of the needle retaining portion 132 is
contacted with the positioning portion 17, so that it is possible
to prevent the fixing portion 18 from jumping up. Thereby, even if
the finger is released, it is possible for the puncture device 11
to be retained in a state in which the puncture needle 14 is stuck
in the dermis D of the uplifted skin (state shown in FIG. 28) and
it is possible to prevent the puncture needle 14 from dropping out
abruptly.
[0463] When the puncture operation by means of the puncture device
11 is terminated, next, a substance such as a medicinal solution,
an immune cell or the like is sent from an injection device such as
an injector (syringe), a liquid transmission pump or the like which
is not shown. Thereby, a substance such as a medicinal solution, an
immune cell or the like is injected into the dermis D through the
tube 139 and the puncture needle 14. Thereafter, when it is desired
to detach the puncture device 11, first, fingers are hooked on the
operation protrusion portion 136 and the slide member 13 is to be
depressed to the fixing portion 18 side. Thereby, the respective
stopper concave portions of the slide member 13 are unfastened from
the stopper protrusion portions 114, 114 of the positioning portion
17 and the slide member 13 becomes slidable to the fixing portion
18 side.
[0464] Next, the slide member 13 is slided and the back face 132c
of the needle retaining portion 132 is contacted with the rising
portion 127 of the latch piece 117. Thereby, the puncture needle 14
pulled out from the skin. At that time, the latch concave portion
138 of the needle retaining portion 132 is engaged with the latch
protrusion portion 128a of the engagement piece 117, so that the
sliding of the slide member 13 is latched.
[0465] Thereafter, the base member 12 is exfoliated from the body
surface F and the detaching of the puncture device 11 is completed.
At that time, it is possible to exfoliate it easily if a portion on
which the adhesive film 15 of the positioning portion 17 is not
mounted is pinched and lifted. Also, the slide member 13 retaining
the puncture needle 14 is latched for the sliding, so that it is
possible to prevent an accidental needlestick, an infection caused
by that accidental needlestick or the like.
[0466] An experiment (experiment 1) was carried out in which blood
kinetics when administering ultra rapid acting type insulin into
the dermis by means of the administration device 501 having a
constitution as mentioned above and blood kinetics when
administering it into the subcutaneous by means of a device used
conventionally (hereinafter, referred to as "conventional devices")
are compared.
[0467] Here, it will be explained with respect to the experiment 1.
In the experiment 1, a plurality of pigs (approximately 10 Kg)
fasted from one day before were made to be administration objects.
Anesthesia was applied to these pigs and shearing hair was carried
out at the administration regions for the medicinal solution and
thereafter, for one group of the pigs, ultra rapid acting type
insulin was administered into the dermis by means of the
administration device 501 and for the other group of the pigs, it
was administered into the subcutaneous by means of the conventional
device, respectively. For the ultra rapid acting type insulin,
Humalog 100 U/ml (produced by Eli Lilly & Co.) was used by
making a dilution thereof in saline such that the applied dose
becomes 0.5 U/kg and the administration volume becomes
approximately 100 .mu.l.
[0468] Also, for the puncture needle 14 of the administration
device 501, a 33 G needle (outer diameter is 0.2 mm manufactured by
Terumo Corp.) was used and was set so as to be stuck as far as the
0.5 mm depth. Then, ultra rapid acting type insulin was filled in a
1 ml syringe showing one embodiment of the injection device jointed
to the tube 139 and administration was carried out manually for 30
seconds. For the puncture needle of the conventional device, a 33 G
injector needle for injecting insulin to subcutaneous (needle
length is 5 mm, manufactured by Terumo Corp.) was used. Then, the
puncture needle of the conventional device was stuck
perpendicularly with respect to the skin and similarly as the
administration device 501, the ultra rapid acting type insulin was
administered for 30 seconds.
[0469] In the administration of ultra rapid acting type insulin to
the dermis and the subcutaneous as mentioned above, blood from the
vein was collected before the administration and after the
administration by 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30
minutes, 40 minutes, 50 minutes, 60 minutes, 90 minutes, 120
minutes and 240 minutes respectively. Then, amounts of insulin in
the circulating blood about the collected respective blood are
measured by chemiluminescence assay (manufactured by Bayer Medical
Ltd.). The measured result thereof is shown in FIG. 31 and table 1.
TABLE-US-00001 TABLE 1 Tmax (min) Cmax (.mu.U/ml) AUC (0-4 h) BA*
dermis (0.5 mm) 10 151.81 132 12% subcutaneous 20 65.7 117.9 -- (5
mm) *with respect to subcutaneous administration
[0470] As shown in FIG. 31 and table 1, in case of administering
insulin to the subcutaneous, the time to maximum blood
concentration (Tmax) was 20 minutes and the maximum blood
concentration (Cmax) was 65.7 .mu.U/ml. Compared with that, the
time to maximum blood concentration (Tmax) was 10 minutes and the
maximum blood concentration (Cmax) was 151.8 .mu.U/ml in a case
where insulin was administered to the dermis. Owing to this fact,
it is comprehended with respect to the administration of insulin to
the dermis that the time to maximum blood concentration (Tmax)
becomes shorter and the maximum blood concentration (Cmax) becomes
higher as compared with the administration to the subcutaneous
which was practiced conventionally.
[0471] the blood concentration time curve
[0472] Also, while the area under the blood concentration-time
curve (AUC) with respect to the administration to the subcutaneous
was 117.9 .mu.Uh/ml, it was 132 .mu.Uh/ml in case of the
administration to the dermis. More specifically, the administration
of insulin to the dermis makes the total amount of drug absorption
in the body to become larger as compared with the administration to
the subcutaneous, and relative bioavailability (BA) of the dermis
administration to the subcutaneous administration is improved by
12%. From the fact mentioned above, it is comprehended that insulin
is absorbed more efficiently and more rapidly and is distributed in
the circulating blood when it is administered to the dermis than
when it is administered to the subcutaneous.
[0473] Next, an experiment (experiment 2) was carried out in which
it was measured the pressure under which the administration can be
continued without leakage when administration liquid is
administered to the dermis.
[0474] Here, it will be explained with respect to the experiment 2.
In the experiment 2, similarly as in the experiment 1, a pig
(approximately 10 Kg) fasted from one day before was made to be an
administration object. Anesthesia was applied to this pig and
shearing hair was carried out at the administration region for the
medicinal solution and thereafter, one puncture needle was stuck by
0.5 mm depth of the skin by using the administration device 501 and
pressure of the administered liquid was measured. There were
prepared for the puncture needle located in the administration
device 501 with two kinds of needles of a 33 G needle having
different diameters (smallest outer diameter is 0.2 mm,
manufactured by Terumo Corp.) and a 30 G needle for dental use
(outer diameter is 0.3 mm, manufactured by Terumo Corp.),
respective needles were located and the measuring was carry out.
Also, physiological saline was used for the administration
liquid.
[0475] Each of the 33 G needle having different diameters and the
30 G needle for dental use located in the administration device 501
was connected through a tube to an HPLC pump (LC-7A, manufactured
by Hitachi High Technologies Co., Ltd.) and a pressure sensor
(PA-860, manufactured by Nidec Copal Electronics Corp.) in which
three-way joint was carried out. Then, the pressure was analyzed by
monitoring the voltage outputted from the pressure sensor by using
a PC data collection system (NR-500.NR-TH08, manufactured by
Keyence Corporation). The administration condition is shown in
table 2. TABLE-US-00002 TABLE 2 administration condition skin depth
Num. of flow rate administration mm needle needles .mu.l/min region
0.5 33 G needle having diff. 1 100 dorsal neck dia. 0.5 30 G 1 100
dorsal neck 0.5 33 G needle having diff. 1 1000 buttock dia. 0.5 30
G 1 1000 buttock 0.5 33 G needle having diff. 1 2000 buttock dia.
0.5 30 G 1 2000 buttock
[0476] As shown in the table 2, applied dose per unit time was made
to be three kinds of 100 .mu.l, 1000 .mu.l and 2000 .mu.l per one
minute and the measurement was carried out twice for each. Also,
the administration portions of the medicinal solution were set to
be a dorsal neck portion and a buttock portion, and physiological
saline was administered by 10 .mu.l per one minute at the dorsal
neck portion and was administered by 1000 .mu.l and 2000 .mu.l per
one minute with respect to the buttock portion which has higher
density of tissues than that of the dorsal neck portion and in
which the administration condition is severe. The leakage of the
physiological saline which was the administration liquid was judged
by the naked eye and the each measurement was finished at the time
when the leakage occurred. The measured result thereof is shown in
table 3 to table 5. TABLE-US-00003 TABLE 3 Administration Speed and
Pressure psi flow rate (kg/cm.sup.2) needle .mu.l/min average Max
Min 33G needle having 100 14 18 (1.2) 10 (0.7) diff. dia. 30G 100
14 18 (1.3) 9 (0.6) 33G needle having 1000 210 331 (23.3) 88 (6.2)
diff. dia. 30G 1000 308 400 (28.1) 216 (15.2) 33G needle having
2000 396 432 (30.4) 360 (25.3) diff. dia. 30G 2000 408 455 (32) 360
(25.3) 1 psi = 6895 Pa
[0477] TABLE-US-00004 TABLE 4 Administration Speed and Leakage from
flow adminis- (%) rate tration from from time until needle
.mu.l/min device skin both leakage 33G needle having 100 0 0 0 not
leak diff. dia. for 20 min. 30G 100 0 0 0 not leak for 20 min. 33G
needle having 1000 50 100 50 2 min. & diff. dia. 10 sec. 30G
1000 0 50 0 2 min. & 18 sec. 33G needle having 2000 100 100 100
1 min. & diff. dia. 34 sec. 30G 2000 50 100 50 1 min. & 45
sec.
[0478] TABLE-US-00005 TABLE 5 Administration Speed and
Administration Amount flow rate administration time until needle
.mu.l/min volume leakage 33G needle having diff. dia. 100 2 ml not
leak for 20 min. 30G 100 2 ml not leak for 20 min. 33G needle
having diff. dia. 1000 2.16 ml* 2 min. & 10 sec. 30G 1000 2.3
ml* 2 min. & 18 sec. 33G needle having diff. dia. 2000 3.13 ml*
1 min. & 34 sec. 30G 2000 3.5 ml* 1 min. & 45 sec. *means
that leakage of administration device is included
[0479] As shown in the table 3, the maximum pressure became 18 psi
in the case of locating the 30 G needle for dental use in the
administration device 501 and administering the physiological
saline by 100 .mu.l/min of flow velocity. Similarly, when the flow
velocity was made to be 1000 .mu.l/min, the maximum pressure became
400 psi and when the flow velocity was made to be 2000 .mu.l/min,
the maximum pressure became 455 psi.
[0480] Also, as shown in the table 4, in the case of administering
physiological saline by 100 .mu.l/min of flow velocity by using the
30 G needle for dental use, it was possible to administer
physiological saline at least for 20 minutes without leakage.
Similarly, in the case of administering physiological saline by
1000 .mu.l/min of flow velocity, it was possible to administer
physiological saline for 2 minutes and 10 seconds without leakage.
Then, when the flow velocity was made to be 1000 .mu.l/min,
probability in which the physiological saline leaked from the
administration device 501 (from joint place of tube and HPLC pump)
was 0% and probability of leakage from the skin was 50%.
[0481] Further, in the case of carrying out the administration by
2000 .mu.l/min of flow velocity, it was possible to administer the
physiological saline for 1 minute and 45 seconds without leakage.
Then, when the flow velocity was made to be 2000 .mu.l/min,
probability in which the physiological saline leaked from the
administration device 501 (from joint place of tube and HPLC pump)
was 50% and probability of leakage from the skin was 100%.
[0482] Also, as shown in the table 5, the applied dose became 2 ml
in the case of administering the physiological saline by 100
.mu.l/min of flow velocity by using the 30 G needle for dental use.
Similarly, when the flow velocity was made to be 1000 .mu.l/min,
the applied dose of the physiological saline became 2.3 ml and when
the flow velocity was made to be 2000 .mu.l/min, it became 3.5 ml.
On the other hand, also with respect to the 33 G needle having
different diameters, as shown in the table 3 to the table 5, it was
possible to obtain an experimental result which shows similar
tendency as in the case of the 30 G needle for dental use.
[0483] As explained above, according to the administration device
of the present invention, it is possible to administer (inject)
substances such as medicinal solution, immune cells and the like
percutaneously to the dermis 100% without leakage and thereby, it
is possible to obtain desired drug efficacy or effects.
Furthermore, by making the puncture needle to go into in parallel
with the dermis layer, it becomes possible to lengthen the distance
from the releasing aperture which exists at the needlepoint of the
puncture needle until the epidermis E and the body surface F, so
that it is possible to make it hard for the substances to be
administered to be leaked to the outside of the epidermis E or the
body surface F. As a result thereof, it is possible to administer
substances such as medicinal solution, immune cells or the like to
the dermis certainly and relatively in a short time.
[0484] It should be noted that the above-described exemplified
embodiments were explained by using examples in which substances
such as medicinal solution, immune cells or the like are
administered always to the dermis, but it is possible to use the
administration device of the present invention also in a case in
which substances are administered to a intracutaneous area, a
subcutis or further a muscle other than the dermis.
[0485] Also, the administration device of the present invention is
not limited by the above-mentioned each exemplified embodiment and
besides that, it is needless to say that various modifications or
changes can be employed for the materials, the constitutions or the
like in the region without departing from the configuration of the
present invention.
DESCRIPTION OF REFERENCE NUMERALS
[0486] 1 . . . puncture device, 2 . . . adhesive pad, 2a . . .
plane, 21 . . . hinge opening (through-hole), 21a . . . opening
window, 22 . . . puncture needle opening, 3 . . . skin deforming
means, 31 . . . support board, 31a . . . opening portion, 31b . . .
base member, 311 . . . opening portion, 311a . . . step portion,
312 . . . guide groove, 32 . . . coil spring, 32a . . . magnet
member, 321 . . . moving table, 321a . . . mounting plate, 321b . .
. side surface plate, 321c . . . slide rail, 322 . . . magnet, 33 .
. . skin bonding member, 33a . . . skin bonding member, 331 . . .
main body plate, 331a . . . guide opening, 332 . . . adhesion
protrusion portion, 332a . . . adhesion surface, 34 . . . adhesive
film, 34a . . . guide pin 35 . . . adhesive film, 4 . . . puncture
needle moving means, 41 . . . injector, 411 . . . puncture needle,
411a . . . needlepoint, 412 . . . fixed outer cylinder, 412a . . .
puncture needle opening, 413 . . . internal outer cylinder, 414 . .
. gasket, 415 . . . plunger, 416 . . . flange, 417 . . . liquid
room, 42 . . . mounting member, 42a . . . upper surface portion,
421 . . . engagement portion, 43 . . . support member, 43a . . .
upper surface portion, 43b . . . lower surface portion, 431 . . .
engagement convex portion, 5 . . . hinge, 5x . . . main body
portion, 5y . . . tabular member, 5a . . . bottom face portion, 5a'
. . . curved surface portion, 5b . . . peripheral wall portion, 5b'
. . . side surface portion, 5c . . . insertion opening, 5d . . .
flange, 5e . . . skin fixing plane, 50a . . . plane, 51a . . .
space, 52b . . . opening portion, 51 . . . fixed piece, 52 . . .
turning piece, 52a . . . skin fixing plane, 53 . . . turning axis,
54 . . . adhesive film, 6 . . . wedge block (turning assistant
member), 6 . . . elastic body (pulling means), 61 . . . hollow
portion, 7 . . . through-hole, 8 . . . adhesive film, 12 . . . base
member, 13 . . . slide member (retaining means), 14 . . . puncture
needle, 14a . . . blade surface, 15 . . . adhesive film (adhesion
member), 17 . . . positioning portion, 18 . . . fixing portion, 19
. . . hinge portion, 112 . . . notch, 113 . . . guide rail (first
guide means), 114 . . . stopper protrusion portion, 116 . . . main
body plate, 117 . . . latch piece, 121 . . . contact surface, 122 .
. . slide guide groove (second guide means), 123 . . . interlink
portion, 123a . . . inclined surface, 124 . . . depressing surface,
125 . . . opening window (through-hole), 127 . . . rising portion,
128 . . . flange portion, 128a . . . latch protrusion portion, 131
. . . slide plate, 132 . . . needle retaining portion, 134 . . .
side surface piece, 134a . . . engagement groove, 136 . . .
operation protrusion portion, 138 . . . latch concave portions, 139
. . . tube, 501 . . . administration device, 11 . . . puncture
device, F . . . body surface, SC . . . stratum corneum, E . . .
epidermis, D . . . dermis, S . . . subcutis, P . . . puncture
region (step portion), X . . . height of depressing surface, Y . .
. distance in height direction from tip of depressing surface until
axis center of puncture needle
* * * * *