U.S. patent application number 17/318432 was filed with the patent office on 2021-08-26 for drug supply device.
This patent application is currently assigned to TERUMO KABUSHIKI KAISHA. The applicant listed for this patent is TERUMO KABUSHIKI KAISHA. Invention is credited to Naoki ISHII, Satoshi SAWADA, Hideaki SHIBATA.
Application Number | 20210259673 17/318432 |
Document ID | / |
Family ID | 1000005583001 |
Filed Date | 2021-08-26 |
United States Patent
Application |
20210259673 |
Kind Code |
A1 |
SAWADA; Satoshi ; et
al. |
August 26, 2021 |
DRUG SUPPLY DEVICE
Abstract
A drug supply device for supplying drug to a living body surface
that includes a shaft and a drug holding sheet attached to the
distal end of the shaft. The drug holding sheet has a first face
that faces distally and a second face opposite the first face that
faces proximally when the drug holding sheet is expanded. The drug
holding sheet includes folded portions that fold such that the
first face is positioned to face radially inward while exposing the
second face to an outside environment when the drug holding sheet
is in a folded state. A drug is applied on the first face of the
drug holding sheet. The drug supply device includes an expandable
member on the second face of the drug holding sheet. The expandable
member is expandable to cause the drug holding sheet to expand from
the folded state into the expanded state.
Inventors: |
SAWADA; Satoshi; (Kanagawa,
JP) ; SHIBATA; Hideaki; (Kanagawa, JP) ;
ISHII; Naoki; (Kanagawa, JP) |
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Applicant: |
Name |
City |
State |
Country |
Type |
TERUMO KABUSHIKI KAISHA |
Tokyo |
|
JP |
|
|
Assignee: |
TERUMO KABUSHIKI KAISHA
Tokyo
JP
|
Family ID: |
1000005583001 |
Appl. No.: |
17/318432 |
Filed: |
May 12, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16126453 |
Sep 10, 2018 |
11039821 |
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17318432 |
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PCT/JP2017/009664 |
Mar 10, 2017 |
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16126453 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 37/00 20130101;
A61B 2017/00623 20130101; A61B 17/00234 20130101; A61K 9/70
20130101; A61B 2017/00659 20130101 |
International
Class: |
A61B 17/00 20060101
A61B017/00; A61M 37/00 20060101 A61M037/00; A61K 9/70 20060101
A61K009/70 |
Foreign Application Data
Date |
Code |
Application Number |
Mar 11, 2016 |
JP |
2016-047970 |
Claims
1. A method comprising: introducing a drug holding sheet into a
living body, the drug holding sheet being connected to a distal end
of an elongated shaft so that movement of the elongated shaft
results in movement of the drug holding sheet, the drug holding
sheet including a first surface on which is located a drug, the
drug holding sheet also including a second surface opposite the
first surface of the drug holding sheet, the drug holding sheet
being expandable from a folded state toward an expanded state and
being foldable from the expanded state to the folded state, the
first surface facing in a distal direction when the drug holding
sheet is in the expanded state and the second surface facing in a
proximal direction when the drug holding sheet is in the expanded
state; the introducing of the drug holding sheet into the living
body including introducing the drug holding sheet into the living
body while the drug holding sheet is in the folded state in which
parts of the first surface of the drug holding sheet on which the
drug is located directly face one another; moving the drug holding
sheet within the living body to position the drug holding sheet
adjacent a treatment site within the living body, the moving of the
drug holding sheet within the living body occurring while the drug
holding sheet is in the folded state; unfolding the drug holding
sheet from the folded state toward the expanded state when the drug
holding sheet is positioned within the living body, the unfolding
of the drug holding sheet causing the parts of the first surface of
the drug holding sheet on which the drug is located to directly
face the treatment site; applying the drug on the first surface of
the drug holding sheet to the treatment site by moving the first
surface of the drug holding sheet into contact with the treatment
site while the drug holding sheet is in the expanded state; and
removing the drug holding sheet from the living body after the
applying of the drug on the first surface of the drug holding sheet
to the treatment site.
2. The method according to claim 1, further comprising folding the
drug holding sheet so that the drug holding sheet is changed to the
folded state in which the parts of the first face directly face one
another, the folding of the drug holding sheet occurring after the
applying of the drug on the first surface of the drug holding sheet
to the treatment site and before the removing of the drug holding
sheet from the living body.
3. The method according to claim 1, wherein the unfolding of the
drug holding sheet from the folded state toward the expanded state
comprises inflating a balloon connected to the drug holding
sheet.
4. The method according to claim 1, wherein the unfolding of the
drug holding sheet from the folded state toward the expanded state
comprises inflating a plurality of spaced apart balloons connected
to the drug holding sheet and positioned on the second face of the
drug holding sheet.
5. The method according to claim 1, wherein the first surface
extends substantially perpendicularly to the elongated shaft when
the drug holding sheet is expanded into the expanded state.
6. A method comprising: introducing a drug holding sheet into a
living body, the drug holding sheet being connected to a distal end
of an elongated shaft so that movement of the elongated shaft
results in movement of the drug holding sheet, the drug holding
sheet including a first face on which is located a drug, the drug
holding sheet also including a second face opposite the first face
of the drug holding sheet, the drug holding sheet being changeable
between a folded state and an expanded state, the first face facing
in a distal direction when the drug holding sheet is in the
expanded state and the second face facing in a proximal direction
when the drug holding sheet is in the expanded state; the
introducing of the drug holding sheet into the living body
including introducing the drug holding sheet into the living body
while the drug holding sheet is in the folded state in which parts
of the first face on which the drug is located directly face one
another; moving the drug holding sheet within the living body to
position the drug holding sheet adjacent a treatment site within
the living body, the moving of the drug holding sheet within the
living body occurring while the drug holding sheet is in the folded
state; unfolding the drug holding sheet from the folded state
toward the expanded state when the drug holding sheet is positioned
within the living body, the unfolding of the drug holding sheet
causing the first side of the drug holding sheet to directly face
the treatment site; and moving the first face of the drug holding
sheet into contact with the treatment site within the living body
while the drug holding sheet is in the expanded state to apply the
drug on the first face of the drug holding sheet to the treatment
site.
7. The method according to claim 6, wherein the unfolding of the
drug holding sheet from the folded state toward the expanded state
comprises inflating a balloon connected to the drug holding
sheet.
8. The method according to claim 6, wherein the unfolding of the
drug holding sheet from the folded state toward the expanded state
comprises inflating a plurality of spaced apart balloons connected
to the drug holding sheet and positioned on the second face of the
drug holding sheet.
9. The method according to claim 6, wherein the unfolding of the
drug holding sheet from the folded state toward the expanded state
comprises inflating a plurality of balloons that each possesses an
elongated linear shape and that each possess a longitudinal extent
that intersects the center of the drug holding sheet.
10. The method according to claim 6, further comprising folding the
drug holding sheet so that the drug holding sheet is changed to the
folded state in which the parts of the first face directly face one
another, the folding of the drug holding sheet occurring after the
drug on the first face of the drug holding sheet is applied to the
treatment site.
11. The method according to claim 10, further comprising removing
the drug supply device from the living body while the drug holding
sheet remains in the folded state.
12. The method according to claim 6, wherein the drug holding sheet
is positioned in a sheath during the introducing of the drug
holding sheet into the living body.
13. The method according to claim 12, further comprising moving the
drug holding sheet distally relative to the sheath to position the
drug holding sheet outside the sheath, the moving of the drug
holding sheet distally relative to the sheath occurring after the
introducing of the drug holding sheet into the living body.
14. A method comprising: moving a drug supply device within a
living body, the drug supply device comprising a drug holding sheet
which has a first face and a second face opposite the first face,
the first face of the drug holding sheet being coated with a drug,
the drug holding sheet being folded throughout the moving of the
drug supply device within the living body so that the first face of
the drug holding sheet does not contact the living body;
positioning the drug holding sheet of the drug supply device
adjacent a treatment site within the living body; unfolding the
drug holding sheet when the drug holding sheet is positioned
adjacent the treatment site within the living body, the unfolding
of the drug holding sheet causing the first face of the drug
holding sheet to directly face the treatment site; and applying the
drug on the first face of the drug holding sheet to the treatment
site within the living body by contacting the treatment site with
the drug holding sheet.
15. The method according to claim 14, further comprising: after the
applying of the drug to the treatment site, folding the drug
holding sheet so that the first face of the drug holding sheet is
again not exposed to the living body; and withdrawing the drug
supply device from the living body while the drug holding sheet
remains folded.
16. The method according to claim 14, wherein the drug supply
device is held within a sheath during the moving of the drug supply
device within the living body.
17. The method according to claim 16, further comprising moving the
drug holding sheet distally relative to the sheath to position the
drug holding sheet outside the sheath after the moving of the drug
supply device within the living body.
18. The method according to claim 16, wherein the drug supply
device further comprises an elongated shaft to which the drug
holding sheet is connected, the elongated shaft including a lumen
that includes open opposite ends, the method further comprising
introducing an endoscope or an image diagnosis device into the
lumen of the elongated shaft, and observing an environment distal
of a distal end of the elongated shaft through operation of the
endoscope or the image diagnosis device while the drug supply
device is in the living body.
19. The method according to claim 14, wherein the drug holding
sheet in an expanded state is a quadrangle when seen in plan
view.
20. The method according to claim 19, wherein the drug holding
sheet includes a center that is attached to a shaft, the drug
holding sheet including a plurality of fold lines along which drug
holding sheet is folded, the plurality of fold lines intersecting
the center of the drug holding sheet.
Description
CROSS-REFERENCES TO RELATED APPLICATIONS
[0001] This application is a divisional application of U.S. patent
application Ser. No. 16/126,453 filed Sep. 10, 2018, which is a
continuation of International Application No. PCT/JP2017/009664
filed on Mar. 10, 2017, and claims priority to Japanese Patent
Application No. 2016-047970 filed on Mar. 11, 2016, the entire
content of all of which is incorporated herein by reference.
TECHNICAL FIELD
[0002] The present invention generally relates to a drug supply
device and method, and particularly to a medical device and method
for supplying a drug to a surface of a living body.
BACKGROUND DISCUSSION
[0003] When a lesion affected area occurs in the body of a patient,
a treatment involving inserting a catheter or the like into the
body and administrating a drug to the lesion affected area has been
known.
[0004] For example, U.S. Pat. No. 6,893,431 discloses a medical
device in which an expandable structure body is attached to a
distal portion of a catheter and a therapeutic patch (to which drug
is fixed) is disposed on the expandable structure body such that,
after the catheter is inserted into the body, the structure body is
expanded to attach the therapeutic patch to the lesion affected
area. The structure body is configured from a plurality of wire
parts expandable to an umbrella shape and the therapeutic patch is
disposed on the plurality of wire parts such that the therapeutic
patch is expanded by expanding the plurality of wire parts. Then,
the expanded therapeutic patch is brought into contact with a
living body surface such as the outer side face, the inner side
face or the like of an organ in the body to supply the drug to the
living body surface.
SUMMARY
[0005] Treatment that suppresses the invasiveness to the living
body can be achieved without performing an extensive surgery by
delivering a therapeutic patch to a lesion affected area through a
catheter in the manner described above.
[0006] However, the medical device disclosed in U.S. Pat. No.
6,893,431 has a problem in that the structure of the expandable
structure body that can expand the plurality of wire parts to an
umbrella shape is complicated.
[0007] Further, when the plurality of wire parts are folded in such
a manner as to close the umbrella, the therapeutic patch disposed
on the plurality of wire parts is also folded. The therapeutic
patch is inserted into the body of a patient in this state (i.e.,
with the therapeutic patch also folded). Although the therapeutic
patch is in a folded state, however, the surface of the therapeutic
patch to which drug is fixed is exposed to the outer side (i.e.,
the surface with the drug is exposed to the environment in the
living body). Therefore, there is the possibility that the surface
of the therapeutic patch may be brought into contact with some
location of the medical device or a component within the body of
the patient when the therapeutic patch is moved to the living body
surface. This unintended contact can make appropriately supplying
the drug to the targeted living body surface relatively more
difficult.
[0008] The drug supply device and method disclosed here can supply
a drug to the living body surface with (increased) certainty while
the drug supply device maintains a (relatively) simple
structure.
[0009] According to one aspect, a method comprises: introducing a
drug holding sheet into a living body, wherein the drug holding
sheet is connected to a distal end of an elongated shaft so that
movement of the elongated shaft results in movement of the drug
holding sheet, and wherein the drug holding sheet includes a first
surface on which is located a drug and a second surface opposite
the first surface of the drug holding sheet. The drug holding sheet
is expandable from a folded state toward an expanded state and is
foldable from the expanded state to the folded state, with the
first surface facing in a distal direction when the drug holding
sheet is in the expanded state and the second surface facing in a
proximal direction when the drug holding sheet is in the expanded
state. The introducing of the drug holding sheet into the living
body includes introducing the drug holding sheet into the living
body while the drug holding sheet is in the folded state in which
parts of the first surface of the drug holding sheet on which the
drug is located directly face one another. The method also
comprises: moving the drug holding sheet within the living body to
position the drug holding sheet adjacent a treatment site within
the living body, with the moving of the drug holding sheet within
the living body occurring while the drug holding sheet is in the
folded state; unfolding the drug holding sheet from the folded
state toward the expanded state when the drug holding sheet is
positioned within the living body, wherein the unfolding of the
drug holding sheet causes the parts of the first surface of the
drug holding sheet on which the drug is located to directly face
the treatment site; applying the drug on the first surface of the
drug holding sheet to the treatment site by moving the first
surface of the drug holding sheet into contact with the treatment
site while the drug holding sheet is in the expanded state; and
removing the drug holding sheet from the living body after the
applying of the drug on the first surface of the drug holding sheet
to the treatment site.
[0010] Preferably, the drug holding sheet includes plural folding
portions and forms a quadrangle centered at a portion thereof
attached to the distal end of the shaft when the drug holding sheet
is developed. The plurality of folded portions includes four first
folded portions of a triangular shape folded such that four corners
of the drug holding sheet overlap with the center of the quadrangle
and four second folded portions folded such that straight line
portions positioned between adjacent ones of the first folded
portions form mountain portions that project toward the front of
the shaft and straight line portions that pass the center of the
quadrangle and bisect the individual first folded portions form
valley portions that project toward the proximal side of the shaft,
and the development member is disposed along two diagonals of the
quadrangle.
[0011] In this case, when the drug holding sheet is developed by
the development member, after the four second folded portions are
individually developed, preferably the four first folded portions
are individually developed.
[0012] Preferably, the drug holding sheet is attached to the distal
of the shaft such that, when the plurality of folded portions is
developed, the first face extends substantially perpendicularly to
the shaft.
[0013] The development member may be configured from a plurality of
balloons in which development fluid can circulate. Preferably, each
of the plurality of balloons has a plurality of bendable nodes, and
when the development fluid is injected, the plurality of balloons
are extended substantially perpendicularly to the shaft, but when
the development fluid is sucked, the plurality of balloons are
gradually curved at multiple stages so as to become concave toward
the front of the shaft.
[0014] Further, the development member may be configured from a
shape memory member.
[0015] At a distal portion of the development member disposed along
the two diagonals of the quadrangle, a needle-shaped member may be
disposed which projects toward the front of the shaft when the drug
holding sheet is developed. In this case, the drug supply device
further includes a patch-shaped therapeutic held on the
needle-shaped member. Furthermore, the drug supply device may be
configured such that the needle-shaped member is removably disposed
on the development member and is indwelled on a living body surface
together with the patch-shaped therapeutic.
[0016] The drug supply device may be configured such that it
further includes a patch-shaped therapeutic adhered to the first
face of the drug holding sheet by temperature-response bonding
agent, and, when a given temperature is exceeded, the patch-shaped
therapeutic is removed from the first face of the drug holding
sheet and is indwelled on the living body surface.
[0017] Further, the drug supply device may be configured such that
the development member disposed along the two diagonals of the
quadrangle has a drug supply lumen, and drug supplied through the
drug supply lumen is discharged from a distal portion of the
development member.
[0018] Further, preferably the shaft has a lumen formed along an
axial direction of the shaft.
[0019] According to another aspect, a method comprises moving a
drug supply device within a living body, wherein the drug supply
device comprises a drug holding sheet which has a first face and a
second face opposite the first face, with the first face of the
drug holding sheet being coated with a drug, and the drug holding
sheet being folded throughout the moving of the drug supply device
within the living body so that the first face of the drug holding
sheet does not contact the living body. The method also involves
positioning the drug holding sheet of the drug supply device
adjacent a treatment site within the living body, unfolding the
drug holding sheet when the drug holding sheet is positioned
adjacent the treatment site within the living body, with the
unfolding of the drug holding sheet causing the first face of the
drug holding sheet to directly face the treatment site; and
applying the drug on the first face of the drug holding sheet to
the treatment site within the living body by contacting the
treatment site with the drug holding sheet.
[0020] Yet another aspect involves a method comprising introducing
a drug holding sheet into a living body, wherein the drug holding
sheet is connected to a distal end of an elongated shaft so that
movement of the elongated shaft results in movement of the drug
holding sheet, and wherein the drug holding sheet includes a first
face on which is located a drug and a second face opposite the
first face of the drug holding sheet. The drug holding sheet is
changeable between a folded state and an expanded state, with the
first face facing in a distal direction when the drug holding sheet
is in the expanded state and the second face facing in a proximal
direction when the drug holding sheet is in the expanded state. The
introducing of the drug holding sheet into the living body includes
introducing the drug holding sheet into the living body while the
drug holding sheet is in the folded state in which parts of the
first face on which the drug is located directly face one another.
The method also includes moving the drug holding sheet within the
living body to position the drug holding sheet adjacent a treatment
site within the living body, with the moving of the drug holding
sheet within the living body occurring while the drug holding sheet
is in the folded state; unfolding the drug holding sheet from the
folded state toward the expanded state when the drug holding sheet
is positioned within the living body, with the unfolding of the
drug holding sheet causing the first side of the drug holding sheet
to directly face the treatment site; and moving the first face of
the drug holding sheet into contact with the treatment site within
the living body while the drug holding sheet is in the expanded
state to apply the drug on the first face of the drug holding sheet
to the treatment site.
[0021] The disclosed drug supply device and method can supply the
drug with certainty to the living body surface while possessing a
relatively simple structure because the drug supply device includes
the drug holding sheet having the plurality of first folded
portions individually folded such that the first face on which the
drug is held is positioned on the inner side and the drug supply
device includes the expandable member disposed on the second face
of the drug holding sheet and deformable to develop the plurality
of folded portions.
BRIEF DESCRIPTION OF THE DRAWINGS
[0022] FIG. 1 is a front side perspective view of a drug supply
device according to an embodiment as viewed from the front of a
shaft when a drug holding sheet is expanded.
[0023] FIG. 2 is a rear side perspective view of the drug supply
device according to the embodiment as viewed from the proximal side
of the shaft when the drug holding sheet is expanded.
[0024] FIG. 3 is a front elevational view of the expanded drug
holding sheet in the embodiment as viewed from the front of the
shaft.
[0025] FIG. 4 is a front elevational view of the drug holding sheet
as viewed from the front of the shaft, which is in an intermediate
state when four first folded portions in the embodiment are
folded.
[0026] FIG. 5 is a front elevational view of the drug holding sheet
as viewed from the front of the shaft, which is in another
intermediate state when the four first folded portions in the
embodiment are folded.
[0027] FIG. 6 is a front elevational view of the drug holding sheet
as viewed from the front of the shaft, which is in a state in which
the four first folded portions in the embodiment are folded.
[0028] FIG. 7 is a front elevational view of the drug holding sheet
as viewed from the front of the shaft, which is in an intermediate
state when four second folded portions in the embodiment are
folded.
[0029] FIG. 8 is a front side perspective view depicting the drug
supply device of the embodiment in a state in which the four first
folded portions of the drug holding sheet are folded.
[0030] FIG. 9 is a front side perspective view depicting the drug
supply device of the embodiment in a state in which the folded drug
holding sheet is wrapped around an extension line of the shaft.
[0031] FIG. 10 is a front elevational view of a drug holding sheet
as viewed from the front of a shaft, which is in an intermediate
state when four second folded portions are folded in another
embodiment.
[0032] FIG. 11 is a front elevational view of the drug holding
sheet as viewed from the front of the shaft, which is in a state in
which four first folded portions are folded in the embodiment shown
in FIG. 10.
[0033] FIG. 12 is a front side perspective view depicting the drug
supply device of the embodiment shown in FIG. 10 in a state in
which the four first folded portions of the drug holding sheet are
folded.
[0034] FIG. 13 is a front side perspective view depicting the drug
supply device of the embodiment shown in FIG. 10 in a state in
which the folded drug holding sheet is wrapped around the
shaft.
[0035] FIG. 14 is a rear side elevational view of a drug supply
device according to another embodiment as viewed from the proximal
side of a shaft when a drug holding sheet is developed.
[0036] FIG. 15 is a side elevational view depicting the drug supply
device according to the embodiment shown in FIG. 14 when the drug
holding sheet is developed.
[0037] FIG. 16 is a side elevational view depicting the drug supply
device according to the embodiment shown in FIG. 14 when the drug
holding sheet is developed so as to extend along the living body
surface.
[0038] FIG. 17 is a partial sectional view depicting a drug supply
device according to another embodiment when a drug holding sheet is
developed.
[0039] FIG. 18 is a partial sectional view depicting a drug supply
device according to another embodiment when a drug holding sheet is
developed.
[0040] FIG. 19 is a sectional view depicting a balloon used in a
drug supply device of another embodiment.
DETAILED DESCRIPTION
[0041] Set forth below is a detailed description of embodiments of
a drug supply device and method representing examples of the
inventive drug supply device and method disclosed here. Note that,
for the convenience of description, there are cases where the
dimensional ratios of the drawings are exaggerated and are
different from the actual ratios.
Embodiment 1
[0042] FIGS. 1 and 2 depict configurations of one embodiment of the
disclosed drug supply device. The drug supply device includes an
elongate shaft 11 and a developable (i.e., expandable and
contractible) drug holding sheet 12 disposed at the distal end of
the shaft 11. FIG. 1 is a perspective view of the drug supply
device, in which the drug holding sheet 12 is developed to a planar
state (i.e., expanded so that the drug holding sheet 12 forms a
plane, i.e., is planar) as viewed from the front (i.e., viewed from
beyond the distal end, looking proximally) of the shaft 11. FIG. 2
is a perspective view of the drug supply device, in which the drug
holding sheet 12 is expanded to a planar state, as viewed from the
proximal side of the shaft 11 (i.e., viewed from proximal to the
drug holding sheet 12, looking distally).
[0043] The drug holding sheet 12 is attached to an outer periphery
of the distal end of the shaft 11 such that, when it is expanded,
the drug holding sheet 12 forms a square (quadrangle) Q1 centered
at a portion thereof at which it is attached to the distal end of
the shaft 11 (i.e., the drug holding sheet 12 is attached to the
distal end of the shaft 11 at the center of the drug holding sheet
12). The drug holding sheet 12 extends substantially
perpendicularly to the shaft 11 when it is expanded.
[0044] The drug holding sheet 12 has a first face 13 (a first
surface) directed toward the front of the shaft 11 (i.e., facing
distally) when the drug holding sheet 12 is expanded as depicted in
FIG. 1, and a second face 14 (second surface) directed toward the
proximal side of the shaft 11 (i.e., facing proximally) when the
drug holding sheet 12 is expanded as depicted in FIG. 2. Drug M is
held on the overall area of the first face 13 (i.e., the drug M
coats or is applied on the first surface of the drug holding sheet
12). Four balloons 15 are disposed on the second face 14. The four
balloons 15 are deformable to a bar-like shape (i.e., an elongated
linear shape) by being individually expanded along two diagonals L1
of the square Q1 of the drug holding sheet 12 centered at the shaft
11.
[0045] The drug holding sheet 12 has a fold pattern along a
plurality of fold lines in advance (i.e., the drug holding sheet 12
is configured to fold in a particular manner, in accordance with a
predetermined fold pattern). The plurality of fold lines
includes:
[0046] (1) two straight lines L2 extending along the sides of the
square Q1 (i.e., parallel to the side edges of the square Q1) and
passing through the center of the square Q1,
[0047] (2) four diagonals L3 that are diagonal lines of four
squares Q2 into which the square Q1 is divided by the two straight
lines L2 and which do not overlap with the diagonals L1 of the
square Q1 (i.e., the diagonals of the square Q1 are defined by the
diagonal L1 toward the outer periphery and the diagonal L4 that is
toward the center as shown in FIG. 3),
[0048] (3) two straight lines L4 that overlap with the two
diagonals L1 of the square Q1 and are positioned on the inner side
of a square Q3 formed from the four diagonals L3, and
[0049] (4) four straight lines L5 that overlap with the two
diagonals L1 of the square Q1 and are positioned on the outer side
of the square Q3 formed from the four diagonals L3.
[0050] The fold lines described above and shown in FIGS. 1-3 have
such a fold habit (i.e., predisposition to fold or a fold pattern)
that the two straight lines L2 and the four straight lines L5
indicated by solid lines in FIGS. 1 and 3 form mountain portions
that project toward the front of the shaft 11 (i.e., distally) and
the four diagonals L3 and the straight lines L4 indicated by broken
lines form valley portions that project toward the proximal side of
the shaft 11 (i.e., proximally).
[0051] The shaft 11 has a lumen 16 formed along an axial direction
of the shaft 11. The lumen 16 is configured such that an endoscope
for universal use or an image diagnosis device such as an
intravascular ultrasonic (IVUS) or optical coherence tomography
(OCT) image diagnosis device can be inserted into the lumen 16 from
a proximal portion and pass through the lumen 16 to the distal end
of the shaft 11 to acquire an image that captures the forward
vision from the distal portion of the shaft 11 (i.e., a view
looking distally beyond the distal end of the shaft 11 can be
captured/imaged).
[0052] On a wall portion of the shaft 11, a balloon expansion lumen
is formed which extends from the proximal portion of the shaft 11
to the disposition position of the drug holding sheet 12 at the
distal portion of the shaft 11. The balloon expansion lumen
communicates with the four balloons 15. The four balloons 15
configure an expansion member, such that the four balloons 15 are
expanded simultaneously into a bar shape (i.e., an elongated linear
shape that resembles a bar or rod) along the diagonals L1 of the
square Q1 of the drug holding sheet 12 by injecting development
fluid through the balloon expansion lumen. The four balloons may be
contracted simultaneously by withdrawing (e.g., sucking) the
expansion fluid through the balloon expansion lumen.
[0053] Although the drug holding sheet 12 has a fold pattern along
the plurality of fold lines in advance as described above, if the
four balloons 15 are expanded into a bar shape along the two
diagonals L1 of the square Q1, then the two diagonals L1 of the
square Q1 are individually extended linearly such that the drug
holding sheet 12 is expanded into a flat plane as depicted in FIGS.
1 and 2.
[0054] On the other hand, if the four balloons 15 are contracted,
then the force for compulsorily extending the two diagonals L1 of
the square Q1 linearly is lost, and the drug holding sheet 12 is
gradually folded in the following manner in accordance with the
fold pattern on the fold lines.
[0055] That is, when the four balloons 15 are in a state in which
the drug holding sheet 12 is expanded to form the square Q1 as
depicted in FIG. 3 and then the four balloons 15 begin to be
contracted (deflated), the drug holding sheet 12 begins to be
folded at the four diagonals L3 such that the first face 13 on
which the drug M is held comes to the inner side first as depicted
in FIG. 4, and the four vertices P1 of the square Q1 upon
development are swollen toward the front of the shaft 11.
[0056] As the folding of the drug holding sheet 12 at the four
diagonals L3 proceeds, the four vertices P1 approach the distal end
of the shaft 11 positioned at the center of the square Q1 as
depicted in FIG. 5. The drug holding sheet 12 continues to be
folded during the contraction of the four balloons 15 until the
four vertices P1 are overlapped with the distal end of the shaft 11
as depicted in FIG. 6 (i.e., the four vertices P1 contract to be
positioned at the distal end of the shaft 11). This folded position
creates a first fold body A of a square shape in which four first
folded portions F1 of a triangular shape are disposed on a plane
around the distal end of the shaft 11 (i.e., the first fold body A
is planar and is positioned at the distal end of the shaft 11).
[0057] If the four balloons 15 are further contracted from the fold
position with the first fold body A shown in FIG. 6, the drug
holding sheet 12 begins to be folded such that portions of the
straight lines L2 positioned between adjacent ones of the first
folded portions F1 form mountain portions projecting toward the
front of the shaft 11 (i.e., protrude distally) and portions of
straight lines L6 that bisect the first folded portions F1 form
valley portions (i.e., contract proximally) as depicted in FIG. 7,
and the four vertices P2 of the first fold body A move toward the
front of the shaft 11 (i.e., contract inward toward the center of
the drug holding sheet 12).
[0058] Then, as the portions of the straight lines L2 and the
straight lines L6 are folded until the portions of the straight
lines L2 are positioned on an extension line extending toward the
front of the shaft 11 (i.e., an axis line of the shaft 11 in the
axial direction extended distally beyond the shaft 11), a second
fold body B is formed as depicted in FIG. 8. In the second fold
body B, the four second folded portions F2 in which the four first
folded portions F1 are folded are disposed around the extension
line of the shaft 11
[0059] Thus, if the four second folded portions F2 are wrapped
around the extension line of the shaft 11 after the four balloons
15 are contracted to form the second fold body B from the drug
holding sheet 12, then the drug supply device can be passed through
a sheath S and inserted into the body of a patient as depicted in
FIG. 9.
[0060] A hub is attached to the proximal portion of the shaft 11,
and such an image diagnosis device such as an IVUS or OCT image
diagnosis device can be inserted into the lumen 16 of the shaft 11
through the hub. Further, injection and suction of fluid for
development for the four balloons 15 can be performed through the
balloon expansion lumen of the shaft 11.
[0061] The formation material of the drug holding sheet 12 and the
balloons 15 is preferably a material having elasticity and a
certain degree of rigidity. For example, the drug holding sheet 12
and/or balloons 15 may be a metal material such as stainless steel,
an aluminum alloy, a shape memory alloy, a superelastic alloy or
the like and a resin material such as polyamide, polyvinyl
chloride, polycarbonate, ABS, polyethylene, polypropylene,
polytetrafluoroethylene, cellulose acetate, polyethersulfone, an
acrylic resin, a silicon resin or the like can be used.
[0062] The shaft 11 material is preferably a material having a
certain degree of flexibility, and a metal or a resin can be used.
As the metal, for example, a pseudoelastic alloy (including a
superelastic alloy) such as a Ni--Ti-based alloy, a shape memory
alloy, stainless steel (for example, all kinds of SUS such as
SUS304, SUS303, SUS316, SUS316L, SUS316J1, SUS316J1L, SUS405,
SUS430, SUS434, SUS444, SUS429, SUS430F, SUS302 and so forth), a
cobalt-based alloy, a precious metal such as gold or platinum, a
tungsten-based alloy, a carbon-based material (including a piano
wire) and so forth can be listed. As a resin, for example,
polyolefin (for example, polyethylene, polypropylene, polybutene,
ethylene-propylene copolymer, ethylene-vinyl acetate copolymer,
ionomer, a mixture of two or more of them and so forth), polymer
materials such as polyvinyl chloride, polyamide, polyamide
elastomer, polyester, polyester elastomer, polyurethane,
polyurethane elastomer, polyimide, fluororesin or the like and
mixtures of them, or two or more ones of the aforesaid polymer
materials are listed. Also it is possible to configure the shaft 11
from a multilayer tube or the like made of a compound formed from
such metals or resins.
[0063] Operation of the embodiment of the drug supply device shown
in FIGS. 1-9 is next described.
[0064] First, the sheath S is inserted into the body of a patient,
and the drug supply device in which the drug holding sheet 12 is
folded and the four second folded portions F2 are wrapped around an
outer periphery of the shaft 11 is inserted into the sheath S
(e.g., the drug supply device is inserted into the sheath S before
the sheath S is inserted into the body of a patient).
[0065] An endoscope or an image diagnosis device (such as an IVUS
or OCT image diagnosis device) is inserted in the lumen 16 of the
shaft 11 and the environment distal to the distal end of the shaft
11 (i.e., the area beyond the distal end of the shaft 11) is
observed. The drug supply device is advanced during this
observation until the distal portion of the shaft 11 reaches a
position in front of a living body surface such as an outer side
surface or an inner side surface of an organ to which drug is to be
supplied. Note that, if the drug holding sheet 12 projects from the
distal end of the sheath S by advancing the drug supply device
relative to the sheath S, then the four second folded portions F2
(having been wrapped around the extension line of the shaft 11) are
spaced away from the outer periphery of the shaft 11 until a state
depicted in FIG. 8 is established.
[0066] The four balloons 15 disposed on the second face 14 of the
drug holding sheet 12 are then expanded by injecting development
fluid into the balloons 15 through the balloon expansion lumen of
the shaft 11, which causes the four second folded portions F2 to
gradually expand from the position depicted in FIG. 7 until the
first fold body A in which the four first folded portions F1 of a
triangular shape are disposed on a plane around the distal end of
the shaft 11 is formed as depicted in FIG. 6.
[0067] The balloons 15 continue to be expanded, so that the first
folded portions F1 are developed (expanded), whereupon the four
vertices P1 are progressively spaced away from the distal end of
the shaft 11 in the radial direction as depicted in the progression
of FIGS. 5 and 4. If the four balloons 15 are expanded fully, then
the drug holding sheet 12 is expanded (developed) to establish a
state in which the square Q1 substantially perpendicular to the
shaft 11 is formed as depicted in FIGS. 1 to 3.
[0068] In this state, the drug supply device is advanced (i.e.,
moved within the living body) until the first face 13 of the
developed drug holding sheet 12 is pressed against and brought into
contact with the living body surface (i.e., at the treatment site
of the human body organ that receives the drug). Consequently, the
drug M held on the first face 13 of the drug holding sheet 12 is
supplied to the living body surface.
[0069] The drug holding sheet 12 is expanded to expose the first
face 13 to be moved to contact the living body surface after the
drug holding sheet 12 has been carried to the front of the living
body surface while the drug holding sheet 12 remains folded such
that the first face 13 on which the drug M is held is positioned on
the inner side (i.e., the first face 13 is folded inward to protect
the drug from being exposed to the living body during the movement
of the drug supply device to position the drug holding sheet 12
near the treatment site). Therefore, even if the drug holding sheet
12 is brought into contact with the inner face of the sheath S or
with a body organization of the patient while the drug supply
device is being maneuvered within the living body, the drug M is
prevented from being released from the drug holding sheet 12. This
helps allow the drug M to be supplied appropriately to the living
body surface. Further, since the drug holding sheet 12 (having been
in the folded state) is developed (expanded) to expose the first
face 13, supply of the drug M to the living body surface over an
overall area can be performed at a time.
[0070] After the supply of the drug M to the living body surface is
completed, the drug supply device is retracted (i.e., withdrawn
from the treatment site) to space the first face 13 of the drug
holding sheet 12 away from the living body surface. The development
fluid is sucked from within the four balloons 15 through the
balloon expansion lumen of the shaft 11 to contract the balloons 15
thereby to form the second fold body B, and then the drug supply
device and the sheath S are pulled out from within the body of the
patient (i.e., the first face 13 with the drug M is folded inward
as described above and shown in the progression of FIGS. 3-9 and
then the drug supply device and the sheath S are removed from the
living body).
[0071] The shaft 11 can be retracted to the sheath S side (i.e.,
retracted proximally relative to the sheath S) during removal of
the drug supply device, so that the drug holding sheet 12 is
accommodated in the sheath S and can be pulled out to the outside
of the body simultaneously with the sheath S. However, there is no
necessity to retract the drug holding sheet 12 into the sheath S
during removal of the drug supply device after the drug holding
sheet 12 is fully folded until the state of FIG. 8. If the balloons
15 are in a contracted state, then it is possible to retract the
drug supply device into the sheath S.
Embodiment 2
[0072] In the embodiment described above and illustrated in FIGS.
1-9, if, upon folding of the drug holding sheet 12, the first fold
body A depicted in FIG. 6 is formed and then the four balloons 15
are contracted, the four vertices P2 of the first fold body A move
to the front of the shaft 11 to form the second fold body B
depicted in FIG. 8 when the first folded portions F1 are
individually being folded along the straight lines L6. In this
second fold body B, the portions on the straight lines L2 are
positioned on the extension line directed forwardly of the shaft 11
(i.e., the drug holding sheet 12 protrudes distally beyond the
distal end of the shaft 11 as show in FIG. 8).
[0073] However, the folding is not limited to the folding method
described above. In the embodiment illustrated in FIGS. 10-13,
after the first fold body A is formed by beginning to fold the drug
holding sheet 12, the drug holding sheet 12 is folded such that,
while the first folded portions F1 are being folded on the straight
lines L6, the four vertices P2 of the first fold body A are moved
toward the proximal side of the shaft 11.
[0074] If the four balloons 15 are contracted from a state in which
the drug holding sheet 12 is developed to form the square Q1 as
depicted in FIG. 3, then the drug holding sheet 12 begins to be
folded on the four diagonals L3 similarly as in the embodiment
described above regarding FIGS. 1-9. When the drug holding sheet 12
is then folded until the four vertices P1 of the square Q1 upon
development (expansion) are overlapped with the distal end of the
shaft 11, a first fold body A in which the four first folded
portions F1 of a triangular shape are disposed in a plane around
the distal end of the shaft 11 is formed (i.e., the first fold body
is planar and located at the distal end of the shaft 11).
[0075] If the four balloons 15 are further contracted from this
state, then the drug holding sheet 12 begins to be folded such that
portions on the straight lines L2 positioned between adjacent ones
of the first folded portions F1 form mountain portions projecting
toward the front of the shaft 11 and portions on the straight lines
L6 that pass the distal of the shaft 11 having been positioned at
the center of the square Q1 and bisect the first folded portions F1
form valley portions that project toward the proximal side of the
shaft 11 while the four vertices P2 of the first fold body A of a
square shape are positioned on the proximal side of the shaft 11 as
depicted in FIG. 10.
[0076] As the portions on the straight lines L2 and the straight
lines L6 are then folded until the portions on the straight lines
L6 contact the outer periphery of the shaft 11, a second fold body
C in which the four second folded portions F2 at which the four
first folded portions F1 are folded are disposed around the shaft
11 is formed as depicted in FIGS. 11 and 12.
[0077] Therefore, after the four balloons 15 are contracted to form
the second fold body C from the drug holding sheet 12, the four
second folded portions F2 are wrapped around an outer periphery of
the shaft 11 so that the drug supply device can be inserted into
the body of a patient through the inside of the sheath S as
depicted in FIG. 13.
[0078] It is to be noted, however, that there is no necessity to
retract the sheath after the developed drug holding sheet 12 is
folded fully thereby to form the state of FIG. 12. In some
embodiments, the sheath can be retracted if the balloons are in a
contracted state.
[0079] Even if the drug holding sheet 12 has a fold habit until the
drug holding sheet 12 comes to such a second fold body C as
described above through the first fold body A, it is possible to
supply the drug M appropriately to the living body surface over a
great area similarly as in the embodiment 1.
[0080] In the embodiments described above in relation to FIGS.
1-13, expansion (unfolding) and contraction (folding) of the drug
holding sheet 12 are performed by performing injection and suction
of fluid (development fluid) into and from the four balloons 15. It
is also possible to dispose, in place of the balloons 15, an
expandable member (a development member) made of a shape memory
alloy or shape memory polymer or else a resilient material such as
polymer or the like on the two diagonals L1 of the second face 14
of the drug holding sheet 12. By inserting the drug holding sheet
12 in a folded state to from a second fold body B into the sheath S
and causing the drug holding sheet 12 to project from the distal of
the sheath S in the proximity of the living body surface, the
expandable member made of a shape memory alloy is expanded and
returns to its initial state or the expandable member made of an
elastic material is expanded by the elasticity of itself. Then,
together with the expansion of the expandable member, the expanded
drug holding sheet 12 is developed (formed).
[0081] In the embodiments described above regarding FIGS. 1-13, an
expandable member formed from the balloons 15 is disposed only on
the two diagonals L1 of the square Q1. The positioning of the
expandable member is not limited to being only on the two diagonals
L1, however, as it is only necessary to structure the development
member such that drug application when the expanded drug holding
sheet 12 developed to the square Q1 is brought into contact with an
affected area (i.e., the target site in the living body) can be
performed with (relative) certainty. For example, also it is
possible to dispose an expandable member on four sides of the outer
periphery of the square Q1. Alternatively, an expandable member may
be disposed on the two diagonals L1 and the four sides of the outer
periphery of the square Q1 individually. In this last example, the
(relative) certainty of expansion of the drug holding sheet 12 can
be improved further.
[0082] In the embodiments described above and illustrated in FIGS.
1-13, the drug holding sheet 12 has a shape of the square Q1 when
expanded. The shape of the drug holding sheet 12, however, is not
limited to being a square. The drug holding sheet 12 may have a
quadrangular shape other than a square shape or may have a
triangular shape or a polygonal shape equal to or greater than a
pentagonal shape. The drug holding sheet 12 also may have a shape
surrounded by such an outline that includes a curve at least along
part of the outer periphery if the drug holding sheet 12 has a
plurality of folded portions that can be folded such that the first
face 13 on which drug is held may be positioned on the inner side
(i.e., so that portions of the first face 13 face one another and
towards an interior of the folded shape of the drug holding sheet
12).
[0083] The drug M can be directly applied or fixed to the first
face 13 of the drug holding sheet 12. It is also possible to
dispose the drug M in the form of a patch-shaped therapeutic like a
so-called needle patch, a sheet-like drug patch or the like on the
first face 13.
[0084] Various drugs that are applied in accordance with individual
treatments can be used as the drug M.
Embodiment 3
[0085] The embodiments described above and shown in FIGS. 1-13 use
the balloons 15 as the expandable member. In some embodiments, it
is also possible to use balloons 25 having a plurality of bendable
nodes 25A as depicted in FIG. 14 in place of the balloons 15.
[0086] The four balloons 25 are configured such that, if
development fluid is injected into the balloons 25, the balloons 25
extend substantially perpendicularly to the shaft 11 as depicted in
FIG. 14. When the development fluid is suctioned (withdrawn) from
the individual balloons 25, then the plurality of nodes 25A are
bent such that they are curved at multi stages so as to gradually
become concave toward the front of the shaft 11.
[0087] Therefore, if the four balloons 25 extend substantially
perpendicularly to the shaft 11 as depicted in FIG. 15, the first
face 13 of the drug holding sheet 12 is pressed against and brought
into contact with a living body surface P that is curved in a
convex shape and then the development fluid is gradually sucked
from the four balloons 25, the plurality of nodes 25A of the
individual balloons 25 are then bent and are curved at multi stages
such that they form a concave shape toward the front of the shaft
11. Consequently, as depicted in FIG. 16, the drug holding sheet 12
has a shape following the convex living body surface P and the drug
can be supplied while the first face 13 of the drug holding sheet
12 contacts with the living body surface P over a greater
range.
Embodiment 4
[0088] A needle-shaped member 15A can be individually disposed
which projects, when the drug holding sheet 12 is expanded, from
the first face 13 toward the front of the shaft 11 as depicted in
FIG. 17 at distal portions of four balloons 15 disposed along two
diagonals L1 of a square Q1 of a drug holding sheet 12.
[0089] The needle-shaped members 15A are configured such that, when
the balloons 15 are in a contracted state, the needle-shaped
members 15A are positioned along the balloons 15, but when the
balloons 15 are expanded, they project, for example,
perpendicularly with respect to the first face 13 of the expanded
drug holding sheet 12 as depicted in FIG. 17.
[0090] A patch-shaped therapeutic 17 is held in front of the drug
holding sheet 12 by puncturing the needle-shaped members 15A
disposed at the distal portions of the four balloons 15 into the
four corners of the patch-shaped therapeutic 17. When the drug
holding sheet 12 is expanded, the patch-shaped therapeutic 17 can
then be pressed against and brought into contact with the living
body surface.
[0091] If the needle-shaped member 15A is removably attached to the
balloons 15, it is possible to allow the balloons 15 to indwell on
the living body surface together with the patch-shaped therapeutic
17 by retracting the balloons 15 and the drug holding sheet 12
after the needle-shaped members 15A puncture an organism of a
living body from the living body surface. Consequently, it becomes
possible to supply a drug over a long period of time. In order to
perform such indwelling of the needle-shaped members 15A, the
attachment force of the needle-shaped members 15A to the balloons
15 may be set to a value lower than pulling force required to pull
out the needle-shaped members 15A which are punctured in (indwelled
in) the organism of the living body.
[0092] Similarly, also it is possible to dispose the needle-shaped
members 15A at the distal portions of the balloons 25 used in the
embodiment shown in FIG. 14.
Embodiment 5
[0093] In the embodiments described above and shown in FIGS. 1-13,
it is also possible to paste a patch-shaped therapeutic 17 to the
first face 13 of the drug holding sheet 12 by a bonding agent 18 as
depicted in FIG. 18. The bonding agent 18 has temperature
responsiveness and is configured such that, if a predetermined
temperature is exceeded, the adhesive strength of the bonding agent
18 decreases. The predetermined temperature can be set, for
example, to a value a little lower than the body temperature of the
patient.
[0094] If the patch-shaped therapeutic 17 is pasted to the first
face 13 of the drug holding sheet 12 using such a bonding agent 18
as described above, then after the patch-shaped therapeutic 17 is
brought into contact with the living body surface, when the
temperature of the bonding agent 18 is increased by the body
temperature of the patient until it exceeds the predetermined
temperature, the adhesive strength of the bonding agent 18
decreases. Therefore, it is possible to dissect (i.e., remove or
peel off) the patch-shaped therapeutic 17 from the first face 13 of
the drug holding sheet 12 thereby to allow the patch-shaped
therapeutic 17 to be indwelled on the living body surface.
[0095] Also it is possible to paste, a patch-shaped therapeutic 17
along the two diagonals L1 of the square Q1 of the drug holding
sheet 12 on the first face 13 of the drug holding sheet 12
corresponding to the four balloons 15 in advance using the bonding
agent 18 and inject heated development (expansion) fluid into the
balloons 15 to raise the temperature of the bonding agent 18 to
remove the patch-shaped therapeutic 17 from the first face 13 of
the drug holding sheet 12. In this case, the predetermined
temperature of the bonding agent 18 can be set to a value higher
than the body temperature of the patient, and the patch-shaped
therapeutic 17 can be removed from the first face 13 of the drug
holding sheet 12 and indwelled on the living body surface without
being influenced by the dispersion of the body temperature of
individual patients.
[0096] Similarly, in the embodiment shown in FIG. 14, the
patch-shaped therapeutic 17 may be pasted to the first face 13 of
the drug holding sheet 12 by the bonding agent 18.
Embodiment 6
[0097] A cross sectional shape of a balloon 35 used in a drug
supply device according to another embodiment is depicted in FIG.
19. The balloon 35 has a development fluid injection lumen 35A and
a drug supply lumen 35B partitioned from each other by a barrier
W.
[0098] The development fluid injection lumen 35A is closed at the
distal end of the balloon 35. By injecting development fluid into
the development fluid injection lumen 35A, the balloon 35 is
expanded.
[0099] Meanwhile, the drug supply lumen 35B is open at the distal
of the balloon 35 and is configured such that a drug supplied
through the drug supply lumen 35B can be discharged into the body
of the patient from the opening at the distal end of the drug
supply lumen 35B.
[0100] The opening of the drug supply lumen 35B may be formed in an
elongation direction of the drug supply lumen 35B along the balloon
35, or the distal end of the drug supply lumen 35B may extend to a
position across an end portion of the drug holding sheet 12 and an
opening may be formed at the distal end of the drug supply lumen
35B in a direction orthogonal to the elongation direction of the
drug supply lumen 35B so as to be directed to the front of the
shaft 11.
[0101] A drug discharged from the opening of the drug supply lumen
35B spreads between the drug holding sheet 12 and the living body
surface and is supplied over a wide range of the living body
surface.
[0102] If the drug holding sheet 12 is structured such that drug
can be distributed from the second face 14 toward the first face
13, for example, by having a plurality of drug passage holes, then
also it is possible for the drug supply lumen 35B to have one or
more openings formed intermediately in the elongation direction of
the drug supply lumen 35B by being formed from a porous material or
the like. The drug discharged from such an opening or openings
circulates from the second face 14 side to the first face 13 side
of the drug holding sheet 12 and spreads between the first face 13
and the living body surface.
[0103] Furthermore, the distal portion of the shaft 11 may be
configured such that it is exposed to a central portion of the
first face 13 of the drug holding sheet 12 as depicted in FIG. 1
and drug is discharged between the drug holding sheet 12 and the
living body surface from the distal portion of the shaft 11 through
a balloon expansion lumen formed on a wall portion of the shaft
11.
[0104] In the embodiment described above and shown in FIG. 19, the
development fluid injection lumen 35A and the drug supply lumen 35B
are disposed in parallel to each other in the inside of the same
balloon 35. It is also possible, however, to form a balloon, in
which a development fluid injection lumen is formed, and a tube, in
which a drug supply lumen is formed, independently of each
other.
[0105] The detailed description above describes a drug supply
device and drug supply method. The invention is not limited,
however, to the precise embodiments and variations described.
Various changes, modifications and equivalents can be effected by
one skilled in the art without departing from the spirit and scope
of the invention as defined in the accompanying claims. It is
expressly intended that all such changes, modifications and
equivalents which fall within the scope of the claims are embraced
by the claims.
* * * * *