U.S. patent application number 11/419951 was filed with the patent office on 2006-12-21 for universal protector cap with auto-disable features for needle-free injectors.
Invention is credited to Nathaniel J. Leon, Michael Mathews, Victor T. Rogatchev.
Application Number | 20060287631 11/419951 |
Document ID | / |
Family ID | 27484460 |
Filed Date | 2006-12-21 |
United States Patent
Application |
20060287631 |
Kind Code |
A1 |
Leon; Nathaniel J. ; et
al. |
December 21, 2006 |
UNIVERSAL PROTECTOR CAP WITH AUTO-DISABLE FEATURES FOR NEEDLE-FREE
INJECTORS
Abstract
Disclosed is a medical device used to prevent the
cross-contamination of patients or injectors in which various
components placed on the injector minimize or eliminate back splash
contamination of the injector.
Inventors: |
Leon; Nathaniel J.;
(Shawnee, KS) ; Rogatchev; Victor T.; (Voronezh,
RU) ; Mathews; Michael; (Lees Summit, MO) |
Correspondence
Address: |
MAYER, BROWN, ROWE & MAW LLP
P.O. BOX 2828
CHICAGO
IL
60690-2828
US
|
Family ID: |
27484460 |
Appl. No.: |
11/419951 |
Filed: |
May 23, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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|
10269548 |
Oct 11, 2002 |
7074210 |
|
|
11419951 |
May 23, 2006 |
|
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|
09685499 |
Oct 10, 2000 |
6802826 |
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10269548 |
Oct 11, 2002 |
|
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60329081 |
Oct 12, 2001 |
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Current U.S.
Class: |
604/192 |
Current CPC
Class: |
A61M 5/30 20130101; A61M
2005/3104 20130101; A61M 5/178 20130101; A61M 2205/11 20130101;
A61M 2005/3118 20130101; A61M 5/31501 20130101; A61M 2005/2013
20130101; A61M 5/204 20130101; A61M 5/20 20130101; A61M 5/3134
20130101 |
Class at
Publication: |
604/192 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Foreign Application Data
Date |
Code |
Application Number |
Oct 12, 1999 |
RU |
99121141 |
Nov 13, 1999 |
RU |
99124268 |
Claims
1. A protector cap for a needle-free injector, comprising: an
insert having an insert orifice; a baffle having a baffle orifice,
wherein the baffle is joined to the insert to form an insert
reservoir; and a disable device located in the insert
reservoir.
2. The protector cap of claim 1, wherein the disable device has an
installed position and a disabled position.
3. The protector cap of claim 2, wherein the disable device
comprises a central washer having a washer orifice.
4. The protector cap of claim 3, wherein the washer orifice aligns
with the insert orifice and baffle orifice when the central washer
is in the installed position.
4. The protector cap of claim 3, wherein the washer orifice is not
aligned with the insert orifice and baffle orifice when the central
washer is in the disabled position.
5. The protector cap of claim 2, wherein the baffle further
comprises a hinge configured to hold the disable device in the
installed position in the insert reservoir.
6. The protector cap of claim 1, wherein the disable device is
activated upon deformation of the cap.
7. The protector cap of claim 1, wherein the disable device is
activated upon disassembly of the cap.
8. The protector cap of claim 1, further comprising a protective
layer suspended within the insert reservoir.
9. The protector cap of claim 1, further comprising a protective
layer covering at least one of the insert orifice, the washer
orifice, and the baffle orifice.
10. An injection system, comprising: an injector having a distal
end and a proximal end, wherein the injector comprises an injector
orifice at the distal end; and a protector cap configured to cover
the injector orifice at the distal end of the injector, wherein the
protector cap comprises an insert having an insert orifice, a
baffle having a baffle orifice, wherein the baffle is joined to the
insert to form an insert reservoir, and a disable device located in
the insert reservoir.
11. The injection system of claim 10, further comprising a
protective layer located between the distal end of the injector and
the protector cap.
12. The protector cap of claim 10, wherein the disable device has
an installed position and a disabled position.
13. The protector cap of claim 12, wherein the disable device
comprises a central washer having a washer orifice.
14. The injection system of claim 13, further comprising a
protective layer covering at least one of the insert orifice, the
washer orifice, and the baffle orifice.
15. A package for storing a plurality of protector caps comprising
an insert having an insert orifice, a baffle having a baffle
orifice, wherein the baffle is joined to the insert to form an
insert reservoir, and a disable device located in the insert
reservoir, comprising: a cradle having at least one row of
separated wells for storing the plurality of protector caps; and an
adhesive strip covering the cradle.
16. A method of administering needle-free injections, comprising:
adapting an injector with a protector cap to minimize contamination
of the injector; and administering a medication through the
injector and the protector cap; wherein the protector cap comprises
an insert having an insert orifice, a baffle having a baffle
orifice, wherein the baffle is joined to the insert to form an
insert reservoir, and a disable device located in the insert
reservoir.
17. The method of claim 16, wherein the step of administering a
medication comprises administering a powder form of medicine.
18. The method of claim 16, wherein the step of administering a
medication includes administering at least one of a DNA vaccine, a
Hepatitis vaccine, a HIV vaccine, an anti-allergen, and a
pharmaceutical.
19. A method of preventing back splash contamination of a
needle-free injector, comprising: adapting the injector with a
protector cap to minimize contamination of the injector; and
administering a medication through the injector and the protector
cap; wherein the protector cap comprises an insert having an insert
orifice, a baffle having a baffle orifice, wherein the baffle is
joined to the insert to form an insert reservoir, and a disable
device located in the insert reservoir.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 10/269,548, filed Oct. 11, 2002, which is a
continuation-in-part application of U.S. application Ser. No.
09/685,499, filed Oct. 10, 2000, which claims priority to Russian
Application No. 99121141, filed Oct. 12, 1999, Russian Application
No. 99124268, filed Nov. 23, 1999, and U.S. provisional application
No. 60/329,081, filed Oct. 12, 2001, the disclosures of which are
incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates to a protector cap with an
auto-disable feature for needle-free drug delivery devices for
animal and human health applications.
BACKGROUND OF THE INVENTION
[0003] The most effective measure to prevent many diseases among
animals and/or humans is the mass immunization with vaccines.
Needle-free injectors have been used to accomplish this task. The
traditional needle-free injectors comprise the basic design, a
housing with an inner power unit, a medication unit, and a nozzle.
The power unit pumps the medication into an under-plunger cavity of
the medication unit chamber and expels the medication through the
nozzle.
[0004] With the use of a typical jet injector, there exists the
possibility of infection transfer from one subject to another by
means of fluids (blood, lymph, medication) reflected from the skin
surface during injection ("back splash") that may get on the nozzle
and be transferred from one patient to the next. Further, in the
injection stage, the contaminated matter can be transferred through
the nozzle to inside the injector such as, for example, into the
cavity and be transmitted to a new patient through a new cap and
nozzle.
[0005] Accordingly, there is a need in the art of needle-free
injection devices to solve the problem of cross-contamination
during mass vaccinations. More particularly, there is a need for a
protector designed for the nozzle head of needle-free injectors,
which halts "back splash" contamination, and which is low enough in
cost to ensure its practical application as a disposable unit even
for mass vaccinations.
SUMMARY OF THE INVENTION
[0006] The preceding problems are solved and a technical advance is
achieved by the present invention. Disclosed is a protector cap for
a needle-free injector having an insert and a baffle integrally
joined and a disable device located between the insert and the
baffle.
[0007] The protective cap may be a one-shot cap. One purpose of
this device is to prevent the multiple use of a cap. This may be
achieved through the removal, replacement, and/or destruction of
the cap at the later stage of the injection.
BRIEF DESCRIPTION OF DRAWINGS
[0008] FIG. 1A demonstrates an exploded view of a simple embodiment
of the present invention.
[0009] FIG. 1B demonstrates the simple embodiment in assembled
form.
[0010] FIG. 2 shows an exploded view of another embodiment of the
present invention in which another component is introduced.
[0011] FIG. 3 shows an exploded view of another embodiment of the
present invention in which some components are modified.
[0012] FIG. 4 shows other embodiments of the present invention in
which a protective layer is shown at various positions.
[0013] FIG. 5 shows yet another embodiment of the present invention
in which an intermediate piece is shown.
[0014] FIG. 6 shows yet another embodiment of the present invention
in which a protective layer is shown at various positions.
[0015] FIGS. 7A-D depict several different embodiments of the
protective layer of the present invention.
[0016] FIG. 8 is one embodiment of the protector cap of the present
invention.
[0017] FIG. 9 is another embodiment of the protector cap of the
present invention.
[0018] FIGS. 10A-C depict the operation sequence of the protector
cap and injector during an injection.
DETAILED DESCRIPTION
[0019] FIG. 1A demonstrates an exploded view of the present
invention. An injector assembly 10 is shown. One purpose of the
injector assembly 10 is to provide needless injection of
medicaments into the skin 12. As described herein, the injector
assembly 10 is provided with a layer, such as protective layer 14.
The protective layer 14 generally comprises a material that is
adapted to permit the injection of medicaments in one direction,
yet minimize or retard the reverse flow. The source of the
medicament jet stream is from an injector 18. In this regard, the
protective layer 14 can serve as a back splash guard. In this
particular, exemplary, and non-limiting embodiment, an optional
baffle 16 is provided to facilitate the diminution of back
splash.
[0020] The baffle 16 may further comprises a baffle orifice 20,
which can take any desired shape or size, depending on the intended
use. In this regard, the length and cross-section of the baffle
orifice 20 will influence how much back splash hits the protective
layer 14. It is contemplated in all embodiments that the size of
the baffle orifice 20 can be sized to minimize disruption of the
medicament jet stream yet maximize the protection afforded by the
protective layer 14. If the baffle orifice 20 is too small, the
baffle 16 may disrupt the jet stream and thereby reduce the energy
of the stream. If too much diminution of the stream energy occurs,
then the jet stream will not penetrate the skin 12 in the desired
fashion to the desired depth.
[0021] Baffle 16 can be sized to accommodate the needed
configuration, and may optionally include baffle wings 15 to ensure
proper skin stand-off. Of course the length and diameters may vary
significantly, but in one example, baffle 16 can be approximately
greater than 11 mm in diameter and 5 mm tall. Generally, the
diameter of the baffle orifice 20 should be slightly larger than
the diameter of the jet stream. Therefore, it does not really
matter how large the baffle orifice 20 is so long as it is slightly
larger than the jet stream diameter, irrespective of the diameter
of the injector orifice 22.
[0022] Injector 18 has an injector orifice 22 at the distal end of
an injector canal 24. The medication sought to be injected travels
through the injector canal 24, exits through the injector orifice
22 and punctures the protective layer 14. The medication jet stream
then enters the baffle orifice 20 and impacts the skin 12. The
energy of the jet stream is chosen to provide the desired
injection, depth, and location. For example, for a deeper
injection, a higher energy will be necessary. The medicament jet
stream then enters the skin 12 and travels to the desired situs.
However, the impact on skin 12 is not without some attendant
consequences. One consequence is that surface tissue, fluids,
cells, and cellular contents are removed or ablated from the
surface of skin 12 and fly about. This back splash of debris can
travel back along the jet stream and impact the baffle 16 and
protective layer 14. The debris, though, is generally not traveling
fast enough to re-puncture the protective layer 14. In this regard,
the protective layer 14 retards or minimizes the debris back splash
into the injector orifice 22 and the injector 18. One function of
the layer 14 is to prevent the contamination of the injector 18. In
this regard, the simple concept of the invention is to protect the
injector orifice 22 from contamination. Thus, in the event no
baffle 16 is used, the injector 18 itself may bear the protective
layer 14.
[0023] The material chosen for the layer 14 may comprise any
material that facilitates a fluid stream puncture in one direction,
yet retard the fluid stream puncture in the opposite direction. For
example, the layer 14 can comprise a biochemically inert material
that is approved for contact with pharmaceuticals, such as but not
limited to, at least one of a plastic, rubber, polymer,
polyethylene, polytetrafloroethylene, polyurethane, polypropylene,
polyolefin, and polysulfone material. In this regard, a material
that permits the perforation by the jet stream in one direction but
then seals upon itself after the jet stream stops is more
desirable. The protective layer or layers are desirably thin, for
example greater than 0.001 mm. Preferably and non-exclusively, the
thickness can range in the about 0.004 to 0.08 mm range with a
further thickness of about 0.2 to 0.5 mm. It should be noted that
the thickness chosen is variable. Protective layer 14 may also be
textured, woven, braided, or so configured to provide a better
adhesion, if necessary, or to provide better attachment, or to
prevent or minimize movement. For example, the layer 14 may have
grooves of various types. As mentioned, the diameter of the
protective layer 14 (if a disc, or the width if a strip) should be
slightly larger than the diameter of the jet stream.
[0024] As shown in FIG. 1A, the components are in exploded view. In
assembly, the baffle 16 can be designed to fit within the injector
18 and sandwich the layer 14 generally between the baffle 16 and
injector 18. Desirably, the injector orifice 22 and baffle orifice
20 should line up to minimize any diminution of the stream energy.
As with any connection and assembly herein, the baffle 16 can be
adapted to provide a friction fit, snap fit, screw fit, or bayonet
fit. Any component herein can also be heatsealed to fit.
[0025] Protective layer 14 can be also adhered, bonded, or
otherwise attached to the injector 18, baffle 16 or to any part as
desired.
[0026] FIG. 1B demonstrates a simple embodiment of the present
invention. As one can see, the protective layer 14 can be generally
sandwiched between baffle 16 and the injector 18. The protective
layer 14 can be totally sandwiched or partially sandwiched between
the components described herein. As the medication is injected out
through injector canal 24 and injector orifice 22, it will
penetrate through the layer 14 and through the baffle orifice
20.
[0027] It should be noted that in any embodiment of the present
invention, the medication need not be liquid. In addition to
aqueous solutions, the present invention may employ suspensions,
aqueous gels, emulsions, or controlled release injectable
medications. One other dosage form includes powder. For example,
Powderject Pharmaceuticals, of Oxford, United Kingdom, and/or
Powderject Vaccines (Madison, Wis.) have developed an injector that
propels medicine in powder form in the same manner as traditional
needle-free injectors. For example, see, U.S. Pat. Nos. 5,733,600;
6,053,889; and 5,899,880; the disclosures of which are expressly
and entirely incorporated herein. Since the powder form of drugs
take up less than 1% of the volume of drugs in liquid form,
adapting the powder injectors to be used in accordance with the
present invention is also contemplated.
[0028] Generally, but not exclusively, the powder particles of one
dose can range in size but are generally 50 microns wide, as
compared to a 500 micron wide syringe needle. In other words,
powder form vaccines, such as recombinant DNA based vaccines,
including Hepatitis B and HIV vaccines, and other medications for
treating influenza, tetanus, erectile dysfunction, allergies, pain,
cancer, etc., are contemplated. Such powder forms may be admixed
with small amounts of sterile water or other physiologically
acceptable diluents (e.g., about 1-10%) to form pastes or
suspensions. Therefore, adapting the powder injectors to have a
protective cap and/or film consistent with the present invention is
within the ordinary skill in the art.
[0029] FIG. 2 demonstrates another embodiment of the present
invention. The injector assembly 10 is shown having a baffle 16 and
an insert 26. The insert 26 can be adapted to form an insert
reservoir 27. Insert 26 also has an insert distal orifice 28.
Insert 26 can be adapted to fit with baffle 16 such that the insert
26 provides an additional benefit of back splash protection, during
or after the injection is completed. Insert 26 can be adapted to
fit with baffle 16 such that insert 26 helps to properly tension
the skin for the injection type (intramuscular, subcutaneous, or
intradermal). As shown in this particular, exemplary, and
non-limiting embodiment, the protective layer 14 is generally
located between, either partially or completely, the baffle 16 and
the injector orifice 22. In this configuration, the jet stream will
exit the injector orifice 22, penetrate through the layer 14, and
exit through the baffle orifice 20 and insert distal orifice 28 to
impact the skin 12. The skin debris will back splash against the
insert 26 and any debris that flies into the insert distal orifice
28 will likely be stopped by the baffle 16. In the event that
debris trajectory permits debris to travel through the baffle
orifice 20, the debris will impact the distal surface 29 of layer
14.
[0030] In this regard, the injector orifice 22 is protected against
contamination. The debris that hits the protective layer distal
surface 29 will likely fall into the insert reservoir 27 and
collect there. Insert 26 can be adapted to fit into the baffle 16
as needed. One benefit of the insert configuration is the
disposability of the unit. As for configuration, the injector
orifice 22 can be varying distances away from the skin 12. For
example, it can be adjacent the skin 12 (where a baffle or insert
is not used and the layer 14 is attached directly to the injector
18), or millimetres away, such as 2-15 mm away. Naturally the
distance chosen will reflect on the stream energy. Desirably, the
injector orifice 22 distance from the skin 12 is chosen with this
in mind. In some configurations, the proximal face of the baffle 16
could be millimetres away from the skin, such as 2-15 mm and
desirably 2-7 mm. Insert orifice 28 diameter is also sized
accordingly, such as 0.001 mm or greater. In one commercial
embodiment, however, the insert 26, baffle 16, and protective layer
14 can be discarded as a unit upon contamination.
[0031] FIG. 3 represents another embodiment of the present
invention. Shown are the baffle 16, insert 26, protective layer 14,
and injector 18. In this configuration the baffle 16 is adapted to
provide a greater surface area exposed to potential back splash.
The insert 26 is also adapted to minimize back splash
contamination. For example, insert 26 has an insert inner surface
30 and an insert outer surface 32. As shown in dotted lines, the
insert 26 can be configured to form "wings" in which the insert 26
will cooperate with the baffle 16. Baffle 16 has a baffle inner
surface 34 that cooperates with the insert 26. As shown in this
embodiment, the insert outer surface 32 is in cooperation with the
baffle inner surface 34. The wings of the insert 26 come into
proximity of each other to form an insert proximal orifice 36. In
this embodiment, any back splash of skin debris entering the insert
distal orifice 28 will likely hit the insert inner surface 30, or
the baffle inner surface 34, or the distal surface 29 of protective
layer 14. In the event insert 26 is configured to not have wings,
any debris can still hit the insert inner surface 30, the baffle
inner surface 34, or the distal surface 29 of protective layer
14.
[0032] FIG. 4 demonstrates yet another embodiment of the invention.
Shown is a plurality of protective layers 14 shown in phantom 38.
In this exemplary and non-limiting embodiment, the protective layer
14 is, shown covering the baffle orifice 20. The protective layer
14 can be integrally formed with the baffle 16 or can be separately
affixed to the baffle 16. In this embodiment, the removal of the
baffle 16 facilitates disposability.
[0033] Also shown is that multiple protective layers 14 are
present. Protective layers 14 can be generally found proximal the
skin, coincident with the insert distal orifice 28, proximal to the
insert distal orifice 28, distal to the baffle 16, distal to the
baffle orifice 20, coincident with the baffle orifice 20, or
proximal to the baffle orifice 20. The number of protective layers
can be chosen to maximize the jet stream energy for puncture
purposes, but diminish back splash contamination potential. Also
shown in FIG. 4 is the assembly in which the insert 26 and baffle
16 are within the injector assembly 18. Where multiple layers are
used, the layers can be attached using bonding, heatsealing, or
sandwiching the layers.
[0034] As seen in FIGS. 7A-D, it should be noted that in any
embodiment herein, the protective layer 14 or film need not be a
separate piece. Rather it may be integrally formed with a
component, such as a septum. For example, the protective layer 14
may be part of the baffle 16 in which that area that will be
punctured by the jet stream is adapted to give way during
injection. For example, if the baffle 16 is made of plastic, then
the area that will serve as the protective layer can be integral
with the baffle 16 yet be "ground" down slightly to make it thinner
or more easily adapted to perforation. In yet another embodiment,
the layer 14 may be separately manufactured then adhered in some
fashion to a component, such as the baffle 16. In yet another
embodiment as shown in FIG. 7D, a plurality of films may also be
used (as shown in phantom lines).
[0035] FIG. 5 demonstrates yet another embodiment of the present
invention. Baffle 16 is provided with a plurality of baffle legs
40. The baffle legs 40 can be adapted to cooperate with an
intermediate piece 42. The intermediate piece 42 has a proximal and
distal end such that various components can be attached to either
or both ends. In this particular, exemplary, and non-limiting
embodiment, intermediate piece 42 has an intermediate piece orifice
44 therethrough. This intermediate piece orifice 44 can be formed
by one or more intermediate piece extensions 46. As with any
orifice described herein, the size and shape of the orifice 44 may
determine the potential back splash contamination and the
interruption of the jet stream energy. Intermediate piece 42 can be
connected to injector 18 and/or baffle 16 and/or insert 26 via an
intermediate piece connector 48. The intermediate piece connector
48 can include any mechanism to attach one piece to another, and
can further include a friction fit, bayonet, or screw fitting.
[0036] Therefore, as medication is extracted from the medication
vial 50, it is drawn into the injector chamber 52 wherein the
injection system 10 then delivers the medication through the
injector canal 24, through the injector orifice 22, into the
intermediate piece 42, through the intermediate piece orifice 44,
and then through the various distal components.
[0037] As shown in FIG. 5, upon exiting the intermediate piece
orifice 44, the medication will penetrate the protective layer 14
and then enter the baffle 16 via the baffle orifice 20, then
through the insert reservoir 27, through the insert distal orifice
28, to then impact the skin 12.
[0038] Skin debris, if it has the correct trajectory, can enter the
insert 26-baffle 16 component. Debris can either strike the baffle
16, such as baffle splash guards 54, or insert 26 itself, or can
strike the protective layer distal surface 29. In the event that
the debris has sufficient energy to re-puncture the layer 14,
debris will then strike the intermediate piece 42, such as the
intermediate piece extensions 46. In this manner, the only manner
in which the injector tip is contaminated is if the debris enters
the intermediate piece 42 at such a precise trajectory that is
flies through the orifice 44 and directly hits the injector orifice
22.
[0039] However, although not shown in FIG. 5, a plurality of
protective layers 14 can be used at various stages along the insert
26, baffle 26, or intermediate piece 42. Intermediate piece 42 can
also include an optional intermediate piece channel 56, which
fluidly communicates with the atmosphere and the intermediate piece
lumen 57. This permits an equalization of pressure in the lumen 57
and also permits any debris in the lumen 57 to be evacuated. As for
size, intermediate piece channel 56 can be approximately any size
but may be about 1 mm.
[0040] Therefore, the injector assembly 10 provides increased
resistance to contamination using a variety of components. It is
noted that in any and all embodiments described herein, no
individual component is critical or necessary for accomplishing the
invention.
[0041] For example, the embodiment of FIG. 5 can be configured so
that it does not have an insert 26, a baffle 16, a protective layer
16, or the intermediate piece 46. In FIG. 5, the addition of the
insert 26 and baffle 16 provide added benefit.
[0042] FIG. 6 demonstrates yet another embodiment of the present
invention. In this embodiment, an insert 26 plays many roles.
First, the insert 26 is provided with an insert connector 60, shown
here by example only, as a screw fitting. The intermediate piece 42
is provided with an intermediate piece distal connector 62, as
shown by example only, as a screw fitting. Accordingly, the
intermediate piece distal connector 62 cooperates with the insert
connector 60 to provide a detachable attachment. The insert 26 is
adapted to provide the same characteristics as the baffle 16 (not
shown) in that it can be adapted to also have an insert splash
guard 64. While the protective layer 14 is shown proximal to the
insert 26, the intermediate piece 42 can also include an
intermediate piece protective layer 66 located anywhere along the
intermediate piece 42. This intermediate piece protective layer 66
is shown in phantom either distal to the intermediate piece orifice
44, coincident with the orifice 44, or proximal to the orifice 44.
In this regard, the intermediate piece protective layer 66 is
distal to the injector orifice 22. In operation, the debris that
enters the insert 26 will likely impact the insert splash guard (s)
64, the protective layer 14, the intermediate piece extension (s)
46, or the intermediate piece protective layer 66. In this regard,
the disposability of the components is enhanced in that the
intermediate piece inner surface 68 remains generally clean in that
most debris stays within the insert 26 or strikes the protective
layers 14,66.
[0043] FIG. 8 depicts another embodiment of the present invention.
The baffle 16 and the insert 26 may be heat-sealed or otherwise
bonded to form an integral protector cap 100 with an insert
reservoir 27. The baffle 16 may be a flat sheet or may have a dome
shape, as depicted in FIG. 8 to facilitate intra-dermal injections,
for example. In one embodiment, the baffle 16 and the insert 26
cannot be taken apart or modified without destroying the protector
cap 100. The baffle 16 includes a flange 80 to which the insert 26
is bonded. In one embodiment, the baffle 16 may include ribs 81 on
the flange 80 to stiffen the cap structure and ensure proper
placement of the baffle layer against the skin and prevent
slippage. The protective cap 100 may further include a disable
device. In one embodiment, the disable device is a central washer
82 located between the baffle 16 and the insert 26 in the insert
reservoir 27. The central washer 82 may also include a washer
orifice 84 that lines up with the baffle orifice 20 and the insert
orifice 28 when the central washer 82 is in an installed position.
For use during an injection, the central washer 82 must be located
in the installed position. Thus, the protector cap 100 creates four
challenges for blood or debris to enter the injector canal 24: the
insert orifice 28, the washer orifice 84, the baffle orifice 20,
and the injector orifice 22.
[0044] Upon injection, the baffle 16 of the protector cap 100
becomes distorted due to the pressure created by the subject's skin
12 or by an injector component, as described below. The baffle 16
may also become distorted during packaging and shipping if not
handled carefully. When the baffle 16 becomes distorted, the
central washer 82 dislodges in the insert reservoir 27. As a
result, the washer orifice 84 no longer lines up with the baffle
orifice 20 and the insert orifice 28, thereby disabling the
protector cap 100 for further use. As a result, entry of the debris
or blood into the injector canal 24 is even more difficult because
the orifices 28, 84, 20 and 22 are no longer aligned. In one
embodiment, the central washer 82 is tinted to a different color
than the insert 26 or baffle 16 so that the user can determine
whether the central washer 82 is in the installed or disabled
position.
[0045] In another embodiment of the protector cap 100 depicted in
FIG. 9, the shape of the baffle 16 may be modified to ease the
disabling of the protector cap 100. The insert 26 may include a
hinge 88 having a lug 90 for holding the central washer 82 in the
installed position. The hinge 88 produces a double hinge line that
allows the baffle 16 to deflect as shown in the operation sequence
of FIG. 10A-C. The hinge 88 provides for programmed deflection of
the baffle 16 to ensure that the central washer 82 is dislodged
before the cap 100 is ejected from the injector 18. Upon
application of pressure, the baffle 16 distorts and pops the
central washer 82 from its installed position on the lug 90 (FIG.
10A) to a dislodged position (FIG. 10B). In one embodiment, a bead
92 has been added near the flange 80 of the baffle 16. The bead 92
locks into a grove or other locking feature of a cap receiver 110
on the injector 18.
[0046] In the operation sequence of FIG. 10, pressure from the cap
receiver 110 of the injector 18 distorts the baffle 16 rather than
pressure from placement against the skin 12. A sliding sleeve 112
in the cap receiver 110 contacts the hinge 88 of the baffle 16,
causing the hinge line of the hinge 88 to flex and knocking the
central washer 82 out of its installed position. Once the central
washer 82 is loose in the insert reservoir 27 of the protector cap
100, the protector cap 100 is disabled and will not allow a stream
from the injector 18 to penetrate. After being disabled, the
sliding sleeve 112 continues to move forward towards subject and
pops the protector cap 100 free of the cap receiver 110. In one
embodiment, the injector 18 cannot be fired unless the protector
cap 100 is in the cap receiver 110.
[0047] The protector cap 100 may further include a protective layer
14, as described above. The protective layer 14 may cover the
insert orifice 28, the washer orifice 84, the baffle orifice 20, or
the injector orifice 22 or may be suspended within the insert
reservoir 27. In another embodiment, the protector cap 100 may
further include an upper washer 86 that holds the protective layer
in place when the protective layer is made from a material that can
not adhere to the material of the baffle 16.
[0048] Protector caps 100 may be packaged individually or in
packets. In one embodiment, protector caps 100 are packaged as part
of a kit. The protector caps 100 may be packaged in individual or
numerous rows. A cradle with a separate well for each protector cap
100 may be sealed with an adhesive strip to provide a contamination
free environment.
[0049] Although the present invention is described by reference to
a single and exemplary embodiments, and the best mode contemplated
for carrying out the present invention has been shown and
described, it is to be understood that modifications or variations
in the structure and arrangements of these embodiments other than
those specifically set forth may be achieved by those skilled in
the art and that such modifications are to be considered as being
within the overall scope of the present invention. It is to be
further understood that the following pending patent applications
owned by the assignee of the instant application are hereby
incorporated by reference in their entirety as if fully set forth
herein: U.S. patent application Ser. No. 09/685,499;
PCT/US00/41122; U.S. patent application Ser. No. 09/685,633;
PCT/US00/27991; U.S. patent application Ser. No. 09/717,548;
PCT/US00/32186; U.S. patent application Ser. No. 09/717,559;
PCT/US00/32187; U.S. Patent Application Attorney Docket No.
02033872 for "Jet Injector System with Hand Piece" filed on Oct.
11, 2002.
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