U.S. patent number 3,795,244 [Application Number 05/329,060] was granted by the patent office on 1974-03-05 for inhalation device.
This patent grant is currently assigned to Syntex Corporation. Invention is credited to Allen K. Herd, Ronald G. Lax.
United States Patent |
3,795,244 |
Lax , et al. |
March 5, 1974 |
INHALATION DEVICE
Abstract
An inhalation device having means to engage the free end of a
powdered medicament-holding capsule as the capsule is pierced to
provide outlet ports for the powdered medicament held therein. Such
engagement ensures that the capsule is completely seated in the
rotary member on which it is supported and thus ensures that the
outlet ports are positioned at the desired locations adjacent the
shoulder of the capsule. Additionally, such engagement enables the
piercing operation to be conducted in any orientation of the
inhalation device. The rotary member, which supports the capsule
during inhalation, is itself supported by a shaft having a polygon
shaped base having n sides. The rotary member has a hollow sleeve
which fits over the shaft, the sleeve having a polygon shaped inner
surface having at least n + 1 sides. During inhalation which causes
the rotary member to spin about the supporting shaft, contact of
the adjacent polygon shaped surfaces with each other positively
causes the walls of the capsule to undergo repeated changes or
radial acceleration whereby the powdered medicament is dispersed
from the capsule.
Inventors: |
Lax; Ronald G. (Palo Alto,
CA), Herd; Allen K. (Cupertino, CA) |
Assignee: |
Syntex Corporation (Panama,
PM)
|
Family
ID: |
23283696 |
Appl.
No.: |
05/329,060 |
Filed: |
February 2, 1973 |
Current U.S.
Class: |
128/203.15 |
Current CPC
Class: |
A61M
15/0028 (20130101); A61M 15/0033 (20140204); A61M
2206/16 (20130101); A61M 2202/064 (20130101) |
Current International
Class: |
A61M
15/00 (20060101); A61m 015/00 (); A61m
015/06 () |
Field of
Search: |
;128/208,266,206,209 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Medbery; Aldrich F.
Attorney, Agent or Firm: Merker; Evelyn K. Hirsch; Joseph
I.
Claims
What is claimed is:
1. An oral inhalation device comprising a hollow elongate housing
having one or more passageways at each end thereof to permit the
passage of air therethrough, one end thereof being adapted for
insertion into the mouth of the user; a shaft supported by said
housing in the hollow portion thereof, said shaft having a
polygon-shaped base of n sides; and a rotary member supported by
said shaft, said rotary member having, on the end thereof furthest
from the end of said housing adapted for insertion into the mouth
of the user, means to receive a medicament-holding capsule, said
rotary member having a sleeve adapted to surround said shaft, said
sleeve having on the hollow internal portion thereof a
polygon-shaped surface having at least n + 1 sides; said
polygon-shaped surfaces being positioned whereby contact thereof
will occur during inhalation-induced rotation of said rotary
member, such contact of said polygon-shaped surfaces serving to
positively induce said rotary member and the capsule held thereby
to move in an eccentric manner such that the medicament is
dispensed from the capsule through outlet ports therein.
2. The inhalation device of claim 1 wherein said polygon-shaped
base of said shaft has four to six sides.
3. The inhalation device of claim 1 wherein said polygon-shaped
inner surface of said sleeve has five to 12 sides.
4. The inhalation device of claim 1 wherein said polygon-shaped
base of said shaft has n sides and the polygon-shaped inner surface
of said sleeve has n + 1 sides.
5. The inhalation device of claim 1 wherein said polygon-shaped
base of said shaft has n sides and the polygon-shaped inner surface
of said sleeve has n + 1 sides, where n is either 4, 5, or 6.
6. The inhalation device of claim 1 further including means to
pierce the capsule adjacent the free end thereof, the free end of
the capsule being the end thereof remote from the end of said
housing adapted for insertion into the mouth of the user; and means
to engage and rigidly support the free end of the capsule during
piercing.
7. The inhalation device of claim 6 wherein said engagement means
is actuated by the operation of said piercing means.
8. The inhalation device of claim 6 wherein said engagement means
comprises resilient spring means terminating in a recess adapted to
receive the free end of the capsule when said spring means is
extended from its original position to the position where said
engagement means contacts the free end of the capsule, said recess
receiving the free end of the capsule prior to the piercing of the
capsule by said piercing means.
9. The inhalation device of claim 8 wherein said piercing means
comprises a pair of opposed piercing members connected by a bent
resilient bridging member and means for urging the piercing members
together for perforating a capsule held by said rotary member to
provide opposed outlet ports therein; said urging means also having
cam means supported thereby for causing said engagement means to
extend from its original position into contact with the free end of
the capsule prior to the piercing of the capsule by said piercing
means.
10. The inhalation device of claim 9 wherein said urging means
comprises a tubular sleeve surrounding said hollow elongate housing
and mounted for slideable movement thereon, said tubular housing
having four cams on the inner periphery thereof spaced apart
90.degree. apart, one pair of opposed cams serving to urge said
piercing members together for perforating the capsule, and the
other pair of opposed cams serving to urge said engagement means
into contact with the free end of the capsule prior to the piercing
of the capsule by said piercing means.
11. The inhalation device of claim 1 further including a
medicament-holding capsule mounted on said rotary member.
12. An article intended for use with a rotary member to thereby
define an oral inhalation device, the rotary member supporting a
medicament-holding capsule; said article comprising a hollow
elongate housing having one or more passageways at each end thereof
to permit the passage of air therethrough, one end thereof being
adapted for insertion into the mouth of a user of the inhalation
device; a shaft supported by said housing in the hollow portion
thereof, said shaft adapted to support the rotary member such that
a capsule held thereby is adjacent the end of said housing remote
from the end thereof adapted for insertion into the mouth of the
user; means to pierce the capsule adjacent the free end thereof,
the free end of the capsule being the end thereof remote from the
end of said housing adapted for insertion into the mouth of the
user; and means to engage and rigidly support the free end of the
capsule during movement of said piercing means through the walls of
the capsule during piercing and withdrawal of said piercing means
from the inner portions of the capsule.
13. The article of claim 12 wherein said engagement means is
actuated by the operation of said piercing means.
14. The article of claim 12 wherein said engagement means comprises
resilient spring means terminating in a recess adapted to receive
the free end of the capsule when said spring means is extended from
its original position to the position where said engagement means
contacts the free end of the capsule, said recess receiving the
free end of the capsule prior to the piercing of the capsule by
said piercing means.
15. The article of claim 14 wherein said piercing means comprises a
pair of opposed piercing members connected by a bent resilient
bridging member and means for urging the piercing members together
for perforating a capsule held by the rotary member to provide
opposed outlet ports therein; said urging means also having cam
means supported thereby for causing said engagement means to extend
from its original position into contact with the free end of the
capsule prior to the piercing of the capsule by said piercing
means.
16. The article of claim 15 wherein said urging means comprises a
tubular sleeve surrounding said hollow elongate housing and mounted
for slideable movement thereon, said tubular housing having four
cams on the inner periphery thereof spaced about 90.degree. apart,
one pair of opposed cams serving to urge said piercing members
together for perforating the capsule, and the other pair of opposed
cams serving to urge said engagement means into contact with the
free end of the capsule prior to the piercing of the capsule by
said piercing means.
17. The article of claim 12 further including a rotary member
supported on said shaft, said rotary member having a
medicament-holding capsule mounted thereon.
18. A rotary member for use with a hollow elongate housing to
thereby define an oral inhalation device, the housing having means
for rotatably supporting the rotary member in the hollow internal
portion thereof; said rotary member comprising a body portion
having a recess therein for receiving a medicament-holding capsule;
said body portion having, on the external portion thereof, a
plurality of fins for causing the rotation of said rotary member as
air is drawn over and around said fins when said rotary member is
positioned on the rotary member supporting means during inhalation;
said body portion having, on the end thereof opposite said recess,
a downwardly depending, elongated, hollow sleeve, said sleeve
having on the hollow internal portion thereof a polygon-shaped
surface; said polygon-shaped surface cooperating with the surface
of the rotary member supporting means when said rotary member is
positioned thereon to positively induce said rotary member and a
capsule held thereby to move in an eccentric manner during
inhalation.
19. The rotary member of claim 18 wherein said body member has,
adjacent said recess, a plurality of slots for causing the walls of
said body member to be sufficiently flexible to receive capsules of
different diameters.
20. The rotary member of claim 18 wherein said polygon-shaped
surface has five to 12 sides.
21. The rotary member of claim 18 wherein said polygon-shaped
surface has five to seven sides.
Description
FIELD OF THE INVENTION
This invention is related to devices for the administration of
powdered medicaments by oral inhalation. More particularly, this
invention relates to an oral inhalation device having means to
engage the free end of a powdered medicament-holding capsule as the
capsule is pierced to provide outlet ports through which the
powdered medicament is dispensed during inhalation. During
inhalation, novel means associated with the support for the rotary
member positively induces the desired eccentric motion which serves
to dispense the powdered medicament through the outlet ports.
BACKGROUND OF THE INVENTION
Related inhalation devices as shown in U.S. Pat. Nos. 3,507,277;
3,518,922; 3,635,219; and, 3,669,113. Other inhalation devices
include those shown in U.S. Pat. Nos. 2,517,482 and 2,573,918; and
Belgium Patent 781,102.
SUMMARY OF THE INVENTION
The oral inhalation device of the present invention includes means
to engage the free end of a powdered medicament-holding capsule as
the capsule is pierced to provide outlet ports for the powdered
medicament held therein. As used in this application, the "free
end" of the capsule refers to that end of the capsule remote from
the end of the device which is inserted into the mouth of the user.
In the embodiment disclosed herein, the engagement means is
actuated by the camming means which causes the capsule to be
pierced at the desired locations adjacent the shoulder of the free
end of the capsule. During the first portion of movement of the
camming means, as it is manually moved to cause the capsule to be
pierced, the engagement means seats against the free end of the
capsule and gently forces it, to the extent possible, into the
recess in the rotary member in which the capsule has been placed.
This action ensures that the capsule will be completely seated in
the recess in the rotary member. During the latter portion of the
movement of the camming means, the engagement means rigidly holds
the capsule in the desired position and thereby assists the
piercing means in piercing the capsule at the desired locations on
the shoulder of the free end of the capsule. Upon manual movement
of the camming means back to its original position, the piercing
means and the capsule engaging means are returned to their initial
position, thus freeing the capsule for rotation upon
inhalation.
The rotary member, which holds the powdered medicament-holding
capsule during inhalation, is supported by a shaft which has a
polygon shaped base having n sides, preferably four to six sides.
The rotary member has a hollow sleeve which fits over the shaft in
such a manner that the polygon shaped inner surface of the hollow
sleeve lies adjacent the polygon shaped surface of the shaft. The
polygon shaped inner surface has at least n + 1 sides up to a
maximum of about 12 sides, but preferably has n + 1 sides. During
inhalation, which causes rotation of the rotary member due to the
flow of air over the vanes thereon, contact of the polygon shaped
surfaces with each other positively causes the rotary member to
rotate in the desired orbital or eccentric manner such that the
powdered medicament is dispensed from the capsule through the
outlet ports made therein during the piercing operation. The
powdered medicament is entrained in the air stream being inhaled,
and carried through the mouth and into the bronchial tract and/or
lungs of the user where the beneficial or therapeutic action of the
medicament takes place.
BRIEF DESCRIPTION OF THE DRAWINGS
The foregoing and still further features and advantages of the
present invention will become more apparent from the following
detailed description, taken together with the accompaning drawings
wherein:
FIG. 1 is a vertical cross-sectional view of an oral inhalation
device incorporating the features of the present invention, the
rotary member being shown only in partial cross-section;
FIG. 2 is a cross-sectional view of the upper portion of the
inhalation device of FIG. 1 showing certain elements thereof in the
"relaxed" position, the cross-sectional portion to the left of the
center line of the device being taken through the center line of
the nesting spring arm of the engagement means while the
cross-sectional portion to the right of the center line of the
device is taken through the center line of the piercing arms;
FIG. 3 is a cross-sectional view of the upper portion of the
inhalation device of FIG. 1 showing the elements thereof in the
piercing position, the cross-sectional portion to the left of the
center line of the device being taken through the center line of
the nesting spring arm of engagement means while the
cross-sectional portion to the right of the center arm line of the
device is taken through the center line of the piercing arms;
FIG. 4 is a cross-sectional view taken along line 4--4 of FIG. 1
showing the mouthpiece and the shaft thereon, but omitting the
rotary member; and
FIG. 5 is a bottom view of the rotary member taken along line 5--5
of FIG. 1.
Referring to FIG. 1, there is shown an inhalation device 10 having
a mouthpiece 12 supporting a shaft 14. As can best be seen in FIG.
4, shaft 14 is supported at the intersection of cross-arms 16 and
18. Openings or passageways 20 are provided to permit air to be
drawn through the device and from the interior of the device into
the mouth of the user. As shown, shaft 14 has a pentagon-shaped
base 22 and an essentially cylindrical upper portion 24 terminating
in a rounded end portion 26.
Supported on shaft 14 is rotary member 28 having, at the lower
portion thereof, a hollow sleeve 30 which fits over and surrounds
shaft 14, including pentagon-shaped base 22. As can best be seen in
FIG. 5, the lower, internal portion 32 of sleeve 30 is hexagonally
shaped about the inner periphery thereof adjacent pentagon-shaped
base 22. The sleeve, and the polygon shaped inner portion thereof,
are of such dimension that, during rotation, the rotary member
rotates in a "wobbling" orbital or eccentric manner. Fins 38 are
positioned about the outer periphery of upper portion 34 of rotary
member 28 and cause the rotary member to rotate when air is drawn
through device 10, as by inhalation. Upper portion 34 has a recess
40 therein in which a powdered medicament-holding capsule 42 is
positioned prior to use. Upper portion 34 can have one or more
(preferably two) slots 35 (as shown in FIGS. 2 and 3) to make the
walls thereof sufficiently flexible to accept capsules of different
diameters.
Connected to the interior end of mouthpiece 12 is a hollow elongate
housing 44 having a necked-down portion 46 adjacent capsule 42.
Slidably mounted on the outer surface of housing 44 is a tubular
sleeve member 48 having two pair of opposed cams 50 and 52 spaced
on the inner periphery thereof. Each cam is spaced 90.degree. apart
from the cam on each side thereof, and passes through an adjacent
slot 54 in the upper portion of housing 44. Cams 52 are held in
position and guided in movements by guide walls 72.
Supported at the end of housing 44 remote from mouthpiece 12 is end
cap 56 which has attached thereto, on the inside thereof toward the
interior of housing 44, engagement means 57 including nesting
spring arms 58 and sleeve 60. At the end of spring arms 58 remote
from end cap 56, the spring arm terminates in a recess 62 of the
same shape as the near-by end portion of capsule 42. Extending from
recess 62 away from capsule 42 and toward end cap 56 is a hollow
cylindrical sleeve 60 adapted to slide over the outer surface of
guide 64.
Before proceeding to a discussion of FIGS. 2 and 3, it should be
noted that the cross-section of each of these two Figures to the
left of the center line of the device is taken through the center
line of one of the nesting spring arms 58 and that the
cross-section of each of these two Figures to the right of the
center line of the device is taken through the center line of one
of the piercing arms 66 (ie, the cross-section in these views has
been rotated clockwise 90.degree. at the center point of each
Figure). Thus, in FIG. 2, the position of one-half of the
engagement means 57 and one of the opposed piercing arms 66 is
shown in the relaxed position, while in FIG. 3 one-half of the
engagement means and one of the opposed piercing arms is shown in
the piercing position. The portions of the engagement means and the
piercing arm not illustrated in these Figures will be the mirror
images of the respective sides as illustrated in FIGS. 2 and 3.
Referring now to FIG. 2 where the engagement means 57 and piercing
arm 66 are shown in the relaxed position, it will be seen that cam
52 contacts the outer surface of adjacent piercing arm 66 having
needle 68 on the lower portion thereof adjacent capsule 42. In a
similar manner, cam 50 contacts the adjacent surface of nesting
spring arm 58. Such cam contact is repeated for the opposed nesting
spring arm and piercing arm not illustrated.
Referring now to FIG. 3, it will be seen that sleeve 48 has been
manually moved downwardly (ie, toward mouthpiece 12), whereby cams
52 cause opposed piercing arms 66 to move inwardly and, eventually,
perforate capsule 42, to thereby provide outlet ports in the
capsule for the dispensing of the powdered medicament held therein.
Cams 50 contact the adjacent surface of opposed nesting spring arms
58 causing, by the resilient nature of the spring arms, the entire
engagement means to extend toward capsule 42 which has been placed
in recess 40. Prior to the time when needles 68 on opposed piercing
arms 66 enter and, thus, perforate capsule 42, recess 60 is seated
against the adjacent end of capsule 42 and, in so doing, causes the
capsule to be gently forced completely into recess 40.
Additionally, the engagement means serves to rigidly hold the
capsule as piercing needles 68 perforate the capsule on the opposed
sides of the free end thereof. This can best be seen in FIG. 3.
Upon manual movement of tubular sleeve 48 back to its original
position as shown in FIG. 2, opposed piercing arms 66 and nesting
spring arms 58 are returned to their original position, whereby
rotary member 28, now holding perforated capsule 42, is free to
rotate as air passes over and through fins 38 during
inhalation.
When sleeve 48 has been manually moved to the position shown in
FIG. 3 (ie, to the full piercing position), extension 51 on cam 50,
as shown in FIG. 3, contacts the bowed nesting spring arm 58 at its
point of maximum width. The same is true for the opposed cam and
nesting spring arm not shown. This configuration prevents the
engagement means from relaxing slightly and thus relieving the
pressure on capsule 42. In this manner, compression is maintained
on capsule 42 during piercing.
In use, the patient unscrews mouthpiece 12 to expose rotary member
28. If a spent capsule remains in recess 40 it is removed and
replaced with a new powdered medicament-holding capsule. The
mouthpiece is then screwed back onto housing 44. Tubular sleeve 48,
which is in position as shown in FIG. 2, is manually moved to the
position shown in FIG. 3 to cause piercing arms 66 to perforate
opposite sides of the capsule, and then is moved back to the
position as shown in FIG. 2. The mouthpiece is inserted into the
mouth of the user. Upon inhalation, rotary member 28 rotates as
air, drawn through passageways 70 (and others not shown) in end cap
56 and slots 54 in housing 44, passes through housing 44 over fins
38. As the rotary member rotates, the hexagon-shaped inner surface
of hollow shaft 30 contacts pentagon-shaped base 22 of shaft 14 and
positively causes an orbital or eccentric motion which, in turn,
causes the powdered medicament held in capsule 42 to be dispensed
through the outlet ports or perforations created by the piercing
operation (ie, movement of sleeve 48 from the position shown in
FIG. 2 to the position shown in FIG. 3, and back to the position
shown in FIG. 2). The powdered medicament is entrained in the
inhaled air, and is carried thereby into the bronchial tract and/or
lungs of the user where the beneficial or therapeutic action takes
place.
The orbital or eccentric motion referred to above is of a type
generally described in U.S. Pat. No. 3,669,113. The polygon shaped
surfaces of this invention positively ensure, however, that the
desired rotational motion will be achieved, and thusly that the
powdered medicament will be quickly dispersed during
inhalation.
The entire device is preferably made of suitable plastic materials,
such as nylon, acetal or polypropylene. A further advantage of the
present invention is that the end cap, with the appropriate
passageways therein, and the piercing arms, in bent U-shaped form,
can be fabricated as an unitary member as opposed to the separate
members as shown in U.S. Pat. No. 3,518,992. When fabricated
according to specification, the normally resilient nature of the
plastic material causes the return of the piercing arms from the
piercing position to the non-piercing position as the tubular
sleeve is manually moved from the position shown in FIG. 3 to the
position shown in FIG. 2. Additionally, such a unitary design
enables this part to be manufactured more easily, and to be
assembled into the inhalation device of this invention more
rapidly, thereby effecting substantial cost reduction in the
manufacturing process.
While the present invention has been described with reference to a
specific embodiment thereof, it will be understood by those skilled
in this art that various changes may be made and equivalents may be
substituted without departing from the true spirit and scope of the
invention. For example, if it is desired to utilize preperforated
capsules, the piercing means and the engagement means can be
omitted; or the piercing means and the engagement means can be
retained and the polygon shaped surfaces of this invention replaced
with other means affording the same function. Additionally,
modifications may be made to adapt a particular situation, material
or composition of matter, structural desirability or then-present
objective to the spirit of this invention without departing from
its essential teachings.
* * * * *