Note: Descriptions are shown in the official language in which they were submitted.
CA 02203778 1997-04-2~
W O 96/13300 PCT~YL95/0037S
APP~J~ JS FOR IN~ N~ A RIGID ~T~
.
The invention relates to an apparatuæ for injecting
the body of hllm~n~ or ~nim~l S with a pharmaceutical
preparation, wherein the preparation is arranged in a
rig.id carrier, wherein the apparatus comprises:
- means for transporting the carrier into the
chamber; and
- a ch~nnel connecting onto the chamber for trans-
por~ing the carrier into the body.
Such an apparatus is known inter alia from
10 WO-93/23110. Such an apparatus is furthermore known in
another form from WO-91/12048.
In both cases of these known apparatus there is the
danger of the injecting apparatus moving relative to the
body during entry, at least at the place of entry of the
15 carrier into the body, which can cause destruction of the
carrier, excessive pain to the body for injecting and the
danger of injection taking place at an incorrect location
in the body.
The object of the present invention is to avoid the
20 above stated problems.
This object is achieved in that the apparatus is
provided with fixation means ~or fixing the end of the
ch~nn~l relative to the skin of the body for injecting.
As a result of these steps an adequate fixation
25 takes place so that the above mentioned dangers are
obvlated.
According to a first embodiment the fixation means
are adapted for clamping engagement on the skin.
According to a second embodiment the fixation means
30 are formed by chamfered protrusions formed on the part
adapted for contact with the skin of the body and ex-
tending substantially in the direction of the axis of the
~h~nnPl .
A preferred embodiment relates to an apparatus for
CA 02203778 1997-04-2~ --
W O96/13300 PCTANL95/00375
injecting the body of hnm~n~ or ~n;m~ls with a pharma-
ceutical preparation, wherein the preparation is arranged
in a rigid carrier, wherein the apparatus comprises: _
a chamber in which the carrier can be placed; _
means for transporting the carrier into the chamber;
a barrel connecting onto the chamber; and
discharging means for supplying pressurized gas to
the chamber for expelling the carrier through the barrel.
A spacer element is arranged which extends round the
10 mouth of the barrel and which is adapted to direct the
air flow preceding the carrier during discharging such
that the air flow is guided at least partially along at
least that part of the skin of the body for injecting
where the carrier then enters the skin.
The danger is hereby avoided of cont~m;n~nts
possibly present on the skin being carried along with the
carrier into the body and there causing infections or
otherwise having an adverse effect. Also avoided is the
danger, particularly when the carrier must be placed
20 through a hirsute skin, of hairs also being carried in by
the carrier and likewise having adverse effects. I
According to another preferred embodiment the spacer
element is adapted to hold the mouth of the barrel at a
distance from the ~n;m~l for injecting at least during
25 discharging.
As a result of these steps the air flow preceding
the carrier can escape between the barrel and the skin,
whereby the required direction of the gas flow is ob- ¦
tained. -~
According to another preferred embodiment the spacer
element is provided with recesses. Due to these recesses
the gas flow escaping between the barrel and the skin can ~ _
also pass through the spacer element without too many
obstructions. ~ -
According to yet another preferred embodiment the
spacer element is provided on its part adapted for con-
tact with the ~n;m~l with engaging means for preventing a
movement o~ the spacer element in the direction perpen-
.
CA 02203778 1997-04-2~
W O96113300 PCT~NL95~00375
dicularly of the axis of the barrel. This prevents so-
cal]ed lateral slippage of the barrel whereby the
position at which the carrier enters the body might be
less reliably determ;ne~.
Other attractive preferred embodiments will be found
in the r~mA ~ n i ng sub-claims.
The present invention will be elucidated hereinbelow
with reference to the annexed drawings, in which:
figure 1 shows a perspective view of an apparatus
10 according to the invention;
figure 2 shows a perspective view of a holder for
carriers for use with the apparatus according to the
invention;
figure 3 shows a partly broken away perspective
15 detail view according to arrow III in figure l;
~ igure 4 shows a partly broken away perspective
detail view according to arrow IV in figure l;
figure 5 shows a partly broken away perspective
detail view of the part shown in figure 4 from the other
20 side.;
~ igure 6 is a partly broken away perspective detail
view of a variant of the mouthpiece shown in figure 3;
figures 7-9 show sectional views of a second variant
of the mouthpiece shown in figure 1 during dif~erent
25 points in time of the injecting;
igures 10-13 show sectional views o~ the apparatus
according to the invention during the actual injecting
operation; and
~ igure 14 is a perspective view o~ an alternative
30 embodiment of the invention.
Shown in figure 1 is an injecting apparatus which is
~ormed by a housing 2 to which is ~ixed a barrel 3, on
the end of which a mouthpiece 4 is arranged. Further
fixed to the housing is a bracket 5 and a pressurized gas
35 reservoir 6 and a hand-grip 7, wherein the apparatus
further comprises a trigger 8. The mouthpiece 4 and
housing 2 are further connected by a connecting tube 9.
The apparatus is suitable for discharging carriers
CA 02203778 1997-04-2~
W O96/13300 PCTn~LgS/00375
10 which are shown in figure 2, wherein carriers 10 are
accommodated in a belt 11. This latter is arranged in a
cassette 12. The cassette has an annular construction,
wherein one part is thickened for receiving the folded
5 belt 11.
When cassette 12 is connected to the injecting
apparatus 1, a removable part 13 is taken from the
cassette, whereafter cassette 12 can be arranged with one
end in an aperture 14 arranged for this purpose. The
10 other end then connects onto an aperture (not shown in
figure 1) arranged on the upper part of the injecting
apparatus.
The mouthpiece 4 is shown in more detail in figure
3. Mouthpiece 4 is fastened onto the barrel 3 by means of
15 a screw connection. It should be noted here that the
actual barrel, i.e. the guide for the carriers 10, is
situated inside the external barrel 3 depicted in figures
1 and 3.
When mouthpiece 4 is pressed against the body for
20 injecting the mouthpiece 4 can move in axial direction
relative to the actual barrel, not shown in figure 3,
wherein mouthpiece 4 can be moved rearward relative to
the relevant barrel and the discharging mechanism is set
into operation.
For discharge of the air pushed out in front of the
carrier 10 the edge 15 of the mouthpiece is provided with
air discharge openings 16. These of course also provide
for discharge of the propellant gas following the carrier
10 .
Further arranged in mouthpiece 4 is an atomizing _
device 17 which is formed by a nozzle 18 which is con- -
nected to a reservoir (not shown in the drawing) received
in the connecting tube 9. For operation thereof use is
again made of the relative movement of the mouthpiece~ _
35 when it is pressed against a body for injecting, res- !
pectively is removed therefrom. For this purpose the
nozzle 18 is provided wi~h a concentric ring 19 and a
spring 20.
CA 02203778 1997-04-2~
W O96tl3300 PCT~L95~00375
It is thus possible to atomize the liquid present in
the reservoir when mouthpiece 4 is pressed against the
body for injecting, but equally to cause atomizing to
take place when the mouthpiece 4 is moved away from the
5 body.
The nozzle 18 is formed such that for instance a
star-shaped marking is applied to the skin. It is of
course likewise possible for other figures to be formed,
for instance circles, squares, triangles etc. It is also
10 possible to adapt the form of the marking by means of the
edge 15 with the recess 16 or another body for placing
between the skin and the nozzle.
The construction of the discharging and safety
mechanism will now be elucidated with reference to figure
15 4. In housing 2 is arranged a frame 21 made of metal in
which the relevant components are mounted.
The internal barrel 22 through which the carriers
are fired is fixedly connected to frame 21. The external
barrel 3 shown in the foregoing figures, which is axially
20 movable relative to the barrel 22, is connected to a
bridge 23 which is connected to two rods 24,25 which
extend through frame 21 and which are guided through the
transverse walls forming part of frame 21. It is possible
to make use of other connecting elements instead of a
25 concentric barrel. When the external barrel 3 is moved in
axial direction the rods 24,25 move therewith. Two
rollers 26,27 are mounted on the rods 24,25. Made in the
rollers are grooves 28 which have a substantially semi-
cylindrical cross section, wherein the rollers are placed
30 relative to each other such that they are almost mutually
impinging and both semi-cylindrical grooves 28 together
form a cylindrical opening which forms the chamber of the
discharging device.
Figure 5 shows the same device, but from the other
35 side. The rods 24,25 are each connected to an L-shaped
body 29 respectively 30 which are mutually joined by
means of a shaft 31. Mounted on shaft 31 is a hook 32
which, when the rods are moved rearward in figure 4, is
CA 02203778 1997-04-2~
W O96/13300 PCT~NL95/00375
also carried along rearward by means of the angle pieces
29,30 and the shaft 31.
The hook 32 engages on a shoulder of a torpedo-
shaped body 32 which is mounted on a shaft 33 extending
5 parallel to the rods 24,25. By means of a helical spring
34 wound round shaft 33 the torpedo-shaped body 32 is
urged forward. Arranged inside shaft 33 is a thrust shaft
35 which, when the ~orpedo-shaped body 32 moves forward
in the direction of arrow 36, strikes thrust shaft 35.
Thrust shaft 35 is in turn adapted to lift the ball
37 of a ball valve 38. The latter is arranged between a
pressurized air line 39 connected to reservoir 9 and a
pressurized air line 40 which leads to the chamber 41
formed by two semi-cylindrical openings 28. When the
15 barrel 3 is thus moved rearward when the mouthpiece 4
makes contact with a body for injecting, the bridge 23,
the rods 24,25, the L-shaped bodies 29,30, the shaft 31,
the hook 32 and therewith the torpedo-shaped body 32 are
thereby moved rearward as far as a stop which is formed
20 by the rear wall of frame 21.
Arranged on the top part of hook 22 is a ball 42
which, as it approaches the stop, rises against an in-
clining wall 43, whereby the hook is raised and the
torpedo-shaped body 32 shoots forward as a result of the
25 spring pressure generated by spring 34, strikes the
thrust shaft 35 and the valve 37 is lifted counter to the
spring force of the spring 42 arranged therein.
A determined quantity of pressurized air from the
pressurized gas cylinder 9 is thus fed to the chamber 41,
30 whereby the carrier 10 is expelled through the internal
barrel 22. As a result of the action of helical springs
45,46 arranged on rods 24,25, the rods and the barrel ,
spring are then urged back to their original position. It
will thus be apparent that by pressing the mouthpiece . _
35 against a body for injecting, a carrier present in
chamber 41 is injected.
When the apparatus is moved away from the body for
injecting, transport of the belt 11 takes place by means
CA 02203778 1997-04-2~
W 0961~33~0 PCTA~L95100375
of a worm wheel and freewheel me~h~n; m (not shown) by
operating the roller 27. It is of course also possible to
have this take place during the movement in the reverse
direction.
A number of the safety mechanisms forming part of
the safety system will now be elucidated.
A first sa~ety mechanism is ~ormed by the trigger 8
which is connected to the lever 9. When trigger 8 is not
actuated and the lever 9 is situated in the position
10 shown in ~igure 4, the rearward movement of rods 24,25
and the components connected thereto is blocked by a
connecting block 47 which is connected to both rods and
the rearward movement of which is prevented by the lever
46. Only when the trigger 8 is actuated can the bridge 47
15 move to the rear and a carrier 10 be discharged.
A further safety mechanism is formed by a pressure
measuring element. As shown most clearly in figure 5, on
the right-hand side of the wall 48 ~orming part of frame
41, i.e. in the space 49 arranged there, prevails the
20 pressure o~ the pressurized gas present in the
pressurized gas cylinder 9. This pressure presses outward
a pin 50 arranged in the relevant wall 48.
On the relevant side of wall 48 is mounted a shaft
51 on which a U-shaped lever 52 is fixed. The U-shaped
25 lever comprises an L-shaped lever 53 which is pressed
against the wall 48 by means of springs 54 arranged on
shaft 51. Only when the pressure inside chamber 49, that
is the pressure of the pressurized gas inside pressurized
gas cylinder 9, reaches a determ;ne~ value is the force
30 exerted by the pin 50 such that it moves the U-shaped
lever 52 downward counter to the spring pressure of
springs 54, whereby movement of the torpedo-shaped body
32 is released. When however this pressure is too low,
the U-shaped lever 52 is situated in its uppermost po-
35 sition whereby movement of the torpedo-shaped body 32 is
prevented, as is discharging of a carrier.
Figure 6 further shows an alternative embodiment of
the mouthpiece. This alternative mouthpiece 56 is con-
CA 02203778 1997-04-2~
W O96/13300 PCTn~L95/00375
structed wholly concentrically round the barrel 22. The
edge 57 of the mouthpiece is here also provided with six
recesses S 8 which in the present case are distributed
evenly along the round edge 57.
Between each of the recesses 58 are thus created
tooth-like protrusions 71. The edge 57 of each of the v
protrusions 71 is defined by an imaginary truncated cone,
the axis of which coincides with the axis of the barrel
3. Due to the truncated cone form the contact surfaces 57
10 are each provided with a flat portion 72 and the in-
clining portion 73 which is located further to the
outside and the form of which is defined by the cone.
This ~orm has the advantage that only by pressing the
apparatus according to the invention against the skin of
15 the body for injecting at a determined angle can
sufficient force be built up to depress the mouthpiece 56
sufficiently far to enable discharging. This will in any
case prevent the apparatus being fired when the angle at
which it is pressed against the skin differs greatly from
20 an angle of 90; this would result in a carrier entering
the body obliquely which, as already explained, is
undesirable. At a larger angle the apparatus will slip on
the skin due to the oblique surface portions 72.
In order to prevent slippage when the apparatus is
25 pressed against the body at a correct angle, tooth-like
protrusions 74 are arranged on the flat portions 72. e
The shown form of the teeth has the further ad- _
vantage that, as stated above in the preamble, it becomes
possible to deflect the air flow coming from the barrel
30 and preceding the carrier, with the useful effect that
the hairs are blown aside in a ring shape from the
position where the carrier enters the body, and wherein
cont~m;n~nts which may be present are also carried away.
Furthermore, the gas flow expelling the carrier is like-
35 wise carried away without having the opportunity to enter
the body, which of course is likewise less desirable.
In addition, two reservoirs 58,59 are arranged here
which are each provided with a liquid and which are
CA 02203778 1997-04-2~
W O96113~00 ' PCTA~L95100375
activated when the mouthpiece 56 is pressed against a
body for injecting. It is for instance possible herein
for the one reservoir 58 to contain a marking fluid,
0 wherein the marking fluid is atomized by the atomizer 60
5 connected thereto to indicate that the relevant body has
been injected, while the other liquid reservoir 59 can
for instance contain a disinfectant liquid which can be
atomized either before or after injection to disinfect
the wound formed by injecting the carrier.
It is noted herein that it is possible to disinfect
or to mark prior to discharging of the carrier, that is
before the actual injecting operation, or to disinfect or
mark after injection. It is even possible to mark before
injecting and then to disinfect or vice versa. It will be
15 apparent that diverse other possible constructions for
mouthpieces are also possible.
This is elucidated with reference to figures 7-9 in
which a second alternative embodiment of a mouthpiece is
shown. This is formed by a mouthpiece 63 inside which is
20 received a reservoir 64 for liquid for atomizing which is
connected to the internal barrel 22 by means of a bracket
65 and which can be operated by means of a thrust disc 66
and a helical spring 67.
Figure 7 shows the rest position, wherein figure 8
25 shows how by pressing the mouthpiece 63 against a body 68
discharging of a carrier 10 is initiated, wherein in
figure 8 is shown that carrier 10 leaves the barrel 22.
With further pressing an atomizer 69 accommodated in
bracket 65 is activated, which atomizes a relevant
30 quantity of the liquid held in reservoir 64.
The design of the mouthpiece is preferably chosen
such that it is possible to inject at an angle of a
m~;mllm of about 30 to the normal of the plane in which
the housing of the body to be injected is located. If the
35 angle is larger the mouthpiece slips and it is no longer
possible to depress the mouthpiece so far that a carrier
can be fired.
This angle of course depends on the form of the
CA 02203778 1997-04-2~
W O96113300 PCT~NL95/00375
carrier, in particular the tip of the carrier. When the
tip is sharp, i.e. the tip has a cone shape with a small
apex angle, injection can take place at a larger angle to
the normal. This is also the case when the radius of the
5 rounding of the tip is small.
Figures 10-13 show schematically how carrier 10
enters the body for injecting. The mouthpiece and the
barrel are only shown schematically here. The body for
injecting 68 is provided with a skin 69 on which are
10 situated hairs 70.
As shown in figure 10, the carrier 10 leaves the
mouth of the barrel 3 and then cuts through the skin 69,
wherein the carrier 10 enters the underlying tissue 68.
The carrier 10 will continue its movement in the tissue
15 68 until this is damped by the density of the tissue 68
and the carrier comes to a stop.
Such a situation is shown in figure 12. It can also
be seen in this figure that as a result of the dynamic
phenomena in the underlying tissue a cavity 70 forms
20 behind carrier 10 which closes after damping of the
movement phenomena, whereafter the situation shown in
figure 13 is obtained. ~ere can be seen that only a very
small wound results which heals easily. The carrier is
subsequently broken down in the body, wherea~ter the
25 pharmaceutical substance present in the carrier can
perform its curative function. This is further described
in the international patent application with publication
number W0-93/23110.
It is pointed out that, as can be seen in figure 10,
30 the air flow moving ahead of the carrier 10 blows aside
the hairs 70 at the position where carrier 10 will enter
the body, so that the hairs will not make entry of the ~ _
carrier difficult. Blowing aside of the hairs moreover
prevents the hairs being carried by the carrier into the . _
35 wound, which would complicate healing of the wound.
Cont~m;n~nts which may be present at the relevant po- _
sition are also carried away.
This provides the option of performing the disin-
-
CA 02203778 1997-04-2
W O96/13300 PCT~NL9510037
11
fecting spray treatment only after entry of the carrier,
which is the opposite of what is usual in the medical and
veterinary arts.
In figure 14 is shown an alternative embodiment of
5 an apparatus according to the invention. This embodiment
comprises two plates 71, 72 respectively which are
mutually connected on their end by means of a hinge 73.
Plates 71,72 are somewhat rounded at their other end and
are slightly widened in the vicinity of this free end.
10 Each of the plates 71,72 is provided on the inner side
with a friction-increasing layer 73. Instead of a
roughened surface it is now possible to make use of for
instance ribs.
Arranged on plate 72 is a ch~nn~l 74 with a sub-
15 stantially circular diameter. In the vicinity of the endof plate 72 and of ch~nnel 74, although still at a
distance therefrom, an opening 75 is arranged in rh~nne
74, the length of which opening is at least as great as
the length of the carriers for introducing with the
20 present apparatus.
Movable in the channel is a plunger 76 which is
joined to a pressing element 77 which can be operated
with the thumb. Around a part of the channel is arranged
a shell 78 outside which the pressing element 77 extends.
A similar shell 79 is otherwise mounted on the other
plate 71, which shell is provided with a thickening 80 to
define the correct position of the fingers.
The operation of this apparatus is as follows: a
fold of skin of an ~nim~l for injecting is grasped by
30 hand, as shown in figure 14, wherein on each of the sides
of the fold of skin is placed a plate 71, respectively 72
c and the two plates are then pressed together counter to
the spring pressure of spring elements 81 fixed at the
hinge 73. A carrier to be injected can subsequently be
35 placed in the opening 75 which can then be pushed inside
through the skin by pressing with the thumb against the
pressing element 77 by means of the plunger 76, in a
m~nnPr which is otherwise per se known with a so-called
CA 02203778 1997-04-2
W O96/13300 PCT~YLS5/0037
12
trocar.
It is herein noted that by fold of skin is not only
understood an actual fold of skin but also for instance a
protruding soft body part, for instance an auricle. It is
5 also important here that it is possible by means of the
invention to obtain fixation of the injectiny apparatus
relative to the skin, which in the prior art is not
possible. It will be apparent that with this "trocar"-
like injecting apparatus it is also possible to use a
10 fixation device as used in the initially described em-
bodiment; the reverse is however e~ually possible; with
an injecting apparatus operating with pressurized gas it
is likewise possible to employ a clamping device for
fixation purposes.
It will be apparent that the construction of the
apparatus according to the invention can be changed in
diverse ways without departing from the inventive con-
cept. It is thus possible in the initially described
embodiment to fix the container for pressurized gas to
20 the apparatus in another manner and to assign it a dual
function, for instance the additional function o~ hand-
grip. There are of course also numerous possibilities for
making a construction as described with reference to
figures 4 and 5, particularly in respect of the safety
25 mechanisms.
