U.S. patent application number 16/818070 was filed with the patent office on 2020-07-02 for auto-injector systems and method for delivering cyst medication on demand.
The applicant listed for this patent is Joseph Onorato. Invention is credited to Joseph Onorato.
Application Number | 20200206426 16/818070 |
Document ID | / |
Family ID | 59191896 |
Filed Date | 2020-07-02 |
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United States Patent
Application |
20200206426 |
Kind Code |
A1 |
Onorato; Joseph |
July 2, 2020 |
AUTO-INJECTOR SYSTEMS AND METHOD FOR DELIVERING CYST MEDICATION ON
DEMAND
Abstract
An auto-injector device including a syringe, a needle arranged
in the vicinity of a first end of the syringe, and a plunger
arranged within the syringe. A volume within the syringe between
the plunger the needle accommodates medicine, such that movement of
the plunger toward the needle dispenses medicine through the
needle. A selection assembly configurable by a user to adjust an
amount of medicine dispensed by the auto-injector device and depth
to which the medicine is delivered. Also, a method for treating a
skin lesion or skin disorder utilizing the auto-injector and a kit
for patient administered treatment.
Inventors: |
Onorato; Joseph; (Oyster
Bay, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Onorato; Joseph |
Oyster Bay |
NY |
US |
|
|
Family ID: |
59191896 |
Appl. No.: |
16/818070 |
Filed: |
March 13, 2020 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15444598 |
Feb 28, 2017 |
10625023 |
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16818070 |
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15240679 |
Aug 18, 2016 |
9694145 |
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15444598 |
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62314616 |
Mar 29, 2016 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/31555 20130101;
A61M 5/31593 20130101; A61M 5/3156 20130101; A61M 5/3158 20130101;
A61M 5/2033 20130101; A61M 5/31585 20130101; A61M 5/20 20130101;
A61M 5/3287 20130101; A61M 5/3155 20130101; A61M 5/3153 20130101;
A61M 5/3159 20130101; A61M 2210/04 20130101; A61M 5/31553 20130101;
A61M 5/31591 20130101; A61M 5/46 20130101; A61M 2230/005 20130101;
A61M 5/42 20130101; A61M 5/24 20130101 |
International
Class: |
A61M 5/315 20060101
A61M005/315; A61M 5/20 20060101 A61M005/20; A61M 5/32 20060101
A61M005/32; A61M 5/42 20060101 A61M005/42; A61M 5/46 20060101
A61M005/46 |
Claims
1-30. (canceled)
31. A device for self-administering of a medicine by a user, the
device comprising: a housing comprising a forward housing element
and a rear housing element; a medicine vial located in the forward
housing element; a needle; a depth selector at a first end of the
forward housing element; a dosage adjuster at an end of the rear
housing element; and an actuator configured to allow
self-administration of the medicine by the user, wherein the depth
selector is configured to change an extent to which the needle
extends from the device, and wherein the dosage adjuster is
configured to change a dose of medicine to be administered.
32. The device of claim 31, wherein the forward housing element is
configured to contain the medicine to be self-administered by the
user and the rear housing element is configured to allow actuation
of the device by the user.
33. The device of claim 31, wherein the needle is replaceable.
34. The device of claim 31, further comprising one or more detents
and complementary protrusions on the depth selector and/or the
forward housing element configured to indicate when a certain depth
has been selected and/or maintain the depth selector and the needle
in a selected position.
35. The device of claim 31, wherein the needle is part of a needle
assembly having a needle base in which the needle is anchored.
36. The device of claim 31, further comprising a needle guide, the
needle guide configured to guide the needle as the needle
penetrates the skin.
37. The device of claim 31, wherein a distance between the depth
selector and the housing decreases as the depth selector is screwed
and the distance increases as the depth selector is unscrewed.
38. The device of claim 31, wherein the depth selector and the
dosage adjuster include indicators.
39. The device of claim 31, further comprising a drive sleeve
connected to the dosage adjuster.
40. The device of claim 31, further comprising a ratchet mechanism
that only permits rotation in one direction with respect to a reset
ring, wherein each click of the ratchet mechanism corresponds to an
increase in the dose of medicine.
41. The device of claim 31, further comprising a spring, the spring
maintaining a forward force on the needle and the medicine vial,
wherein torque is applied to the spring during rotating of the
dosage adjuster, and wherein, pressing the actuator releases the
spring thereby delivering the dose of medicine into the skin of the
user.
42. The device of claim 31, further comprising a plunger located in
the medicine vial.
43. The device of claim 31, wherein the depth selector is
configured to rotate to change an extent to which the needle
extends from the device.
44. The device of claim 31, wherein the dosage adjuster is
configured to rotate to change a dose of medicine to be
administered.
45. The device of claim 31, wherein the depth selector is
configured to adjust the depth of the needle and the dosage
adjuster is configured to adjust the dose of the medicine based on
a measured diameter and a measured height of a skin lesion or skin
disorder.
46. The device of claim 31, wherein the depth selector and the
dosage adjuster form a selection assembly, the selection assembly
directly corresponding to measurements on a measurement guide.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation application of U.S.
patent application Ser. No. 15/444,598, filed Feb. 28, 2017, which
is a divisional of U.S. patent application Ser. No. 15/240,679,
filed Aug. 18, 2016, which issued as U.S. Pat. No. 9,694,145 on
Jul. 4, 2017, which claims priority to U.S. provisional patent
application 62/314,616, filed Mar. 29, 2016, the entire contents of
the disclosures of which are hereby incorporated by reference in
their entireties.
TECHNICAL FIELD
[0002] The present invention relates to an auto-injection device
that is configurable by a patient to administer varying doses of a
medicine. The invention also relates to a method for a patient to
configure an auto-injection device and administer a particular dose
of medicine and operating the auto-injection device to administer
the dose of medicine. In particular the method relates to
self-treatment of by a patient of acne cysts.
BACKGROUND
[0003] All aspects of medical practice continue to change at a
rapid pace. In fact, everything from insurance to new drugs and
medical devices to the nature of the doctor-patient relationship is
changing. Additionally, prevalent advertising by pharmaceutical
companies makes patients aware of the latest developments in drugs.
Furthermore, the internet has made information widely
available.
[0004] In some ways, the changes may be good. For example, the
internet can provide almost instantaneous access to patient records
for both physicians and patients. On the other hand, the internet
permits dissemination of massive amounts of erroneous medical
information. Other changes are negative. For example, decreased
reimbursement rates and rising costs, such as for medical
malpractice insurance, create great pressures on profitability.
[0005] In some ways, these changes are interrelated and can provide
benefits to both physicians and patients. For example, patient
access to medical records can reduce staff time responding to
patient inquiries. The internet and telephone may provide benefits
beyond dissemination of information. For example, physicians and
other providers may interact with patients on the telephone to
diagnose conditions. Additionally, the internet may be utilized to
send photos or videos relevant to conditions.
BRIEF SUMMARY OF THE INVENTION
[0006] Embodiments of the invention include an auto-injector
device. The device includes a syringe. A needle is arranged in the
vicinity of a first end of the syringe. A plunger is arranged
within the syringe. A volume within the syringe between the plunger
and the needle accommodates medicine, such that movement of the
plunger toward the needle dispenses medicine through the needle. A
selection assembly is configurable by a patient to adjust an amount
of medicine dispensed by the auto-injector device and depth to
which the medicine is delivered.
[0007] Other embodiments of the invention include method for
self-administration of medicine by a patient. The patient measures
a size of a cyst on a skin surface of the patient. The patient
configures a selection assembly of an auto-injector to administer a
dose of medicine including an amount of medicine based on the size
of the cyst. The patient administers the medicine by causing a
plunger of the auto-injector to advance through a syringe of the
injector.
[0008] Still other objects and advantages of the present invention
will become readily apparent by those skilled in the art from the
following detailed description, wherein is shown and described only
the preferred embodiments of the invention, simply by way of
illustration of the best mode contemplated of carrying out the
invention. As will be realized, the invention is capable of other
and different embodiments, and its several details are capable of
modifications in various obvious respects, without departing from
the invention. Accordingly, the drawings and description are to be
regarded as illustrative in nature and not as restrictive.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The above-mentioned objects and advantages of the present
invention will be more clearly understood when considered in
conjunction with the accompanying drawings, in which:
[0010] FIG. 1 represents a patient with an inflamed lesion or other
skin disorder;
[0011] FIG. 2 represents an embodiment of a measuring grid that may
be utilized with the auto-injector to measure diameter and height
of a lesion or other skin disorder;
[0012] FIG. 3 represents a side view of the embodiment of the
measuring grid shown in FIG. 2;
[0013] FIG. 4 represents a cross-sectional view of an embodiment of
an auto-injector;
[0014] FIG. 5 represents a plan view of an end of an embodiment of
an auto-injector including an embodiment of a guide for positioning
the needle on a patient's skin prior to administration of
medicine;
[0015] FIG. 6 represents a plan view of another embodiment of an
auto-injector;
[0016] FIG. 7 represents an exploded view of the embodiment shown
in FIG. 6;
[0017] FIGS. 8 and 9 represent views of the embodiment shown in
FIGS. 6 and 7 during use; and
[0018] FIG. 10 represents an embodiment of an auto-injector
kit.
DETAILED DESCRIPTION OF THE INVENTION
[0019] Effective and timely treatment at reduced cost would be an
ideal scenario. Patient self-administration may be one element that
could help achieve such a goal. Additionally, unlike in the past
where remote interactions between physicians and patients included
only voice communication through the telephone, the internet can
permit the transmission of documents, photos and video. Ease of
transmission of information may also facilitate medical care.
[0020] Effective self-administration of medication may be enhanced
by simplifying the administration technique. For example, a great
deal of time was expended to simplify instructions for automatic
external defibrillators to help ensure that patients could easily
and effectively use them. Additionally, the adaptability of the
administration technique to multiple conditions may further enhance
the effectiveness of self-administration of medication.
[0021] The auto-injector could be prescribed or provided to
patients during an office visit. The patient could take the
auto-injector home or pick it up from a pharmacy to have when
needed. Alternatively, the patient could fill the prescription when
needed. Additionally, a patient could contact a physician, nurse
practitioner, physician's assistant, nurse or other provider, over
the telephone, through e-mail or other means, discuss the patient's
condition and possibly view photos or video of the patient's
condition. The auto-injector could be prescribed to a patient
without an office visit.
[0022] Eliminating an office visit could eliminate the need for an
appointment, saving time. In fact, a patient could obtain an
auto-injector to have at home or when away from home, such as at
school, work or on a business or leisure trip. Additionally,
eliminating the need for an appointment could eliminate the need
for a referral and a co-pay. Perhaps most importantly, the patient
can achieve immediate treatment upon developing any one of a number
of conditions.
[0023] A variety of conditions may be self-treated by patients
utilizing the auto-injector. For example, an acne cyst, such a cyst
anywhere on the body or an inflamed acne cyst. Additionally,
inflamed sebaceous cysts, bug bites, erythema nodusum, alopecia
areata, hypertrophic scars, keloids, granuloma annulare, discoid
lupus erythematosus, hypertrophic lichen planus, lichen
planopilaris, lichen simplex chronicus, psoriasis, sarcoidosis,
prurigo nodularis, viral warts, vascular anomalies, carcinomas,
karatoacanthomas, Kaposi sarcoma, lupus erythematosus, sarcoidosis,
lentigo maligna, Peyronie's disease, and genital warts are among
the conditions that could be treated. Immediate treatment could
greatly speed recovery time. For example, a condition could be
resolved in one day.
[0024] Such conditions typically involve a lesion. The lesion may
be generally round. Typically, the lesions are generally circular,
papules or nodules, elevated bumps or lumps. Such lesions may be
inflammatory in nature. Rather than being round, the lesions could
be linear, curvilinear, or annular. A plurality of lesions could be
arranged in a linear, curvilinear or annular pattern. Lesions may
also not result from inflammatory processes. Additionally, the
lesions may not be raised and could have other shapes.
[0025] As described below in greater detail, the auto-injector not
only permits patient self-administration, a patient may control
dose administered by the auto-injector, thereby increasing the
potential of the auto-injector to save money. Along these lines,
the auto-injector may be able to treat lesions and skin disorders
of different sizes and a vast number of dermatological and other
conditions. Currently, patients must make an appointment, perhaps
obtain pre-authorization for a specialist visit, take time to
travel to the physician's office, wait in the office and then have
a cyst injected with medication. The auto-injector has the
possibility to revolutionize treatment in many ways, including
savings of time and money.
[0026] FIG. 1 illustrates a patient 50 with an inflamed lesion or
other skin disorder 52. When a lesion is identified for treatment,
typically, the lesion is measured to help ensure that a correct
dosage of medicine is administered. The diameter and/or the height
of the lesion may be measured. This may be carried out utilizing a
ruler or other measuring device. According to one embodiment,
evaluation of a lesion for proposed dose and depth of medicant may
be carried out utilizing a measuring grid. FIGS. 2 and 3 illustrate
an embodiment of a measuring grid 31 that may be utilized to
measure a lesion. This embodiment of the measuring grid includes a
plurality of holes to measure different size lesions. The size of
the openings in the measuring grid may vary depending at least in
part upon the cause of the lesion-some conditions tend to generate
large lesions and some small.
[0027] Typically, a measuring grid includes a plurality of openings
of different sizes. The embodiment shown in FIGS. 2 and 3 includes
openings 33 having diameters of about 6 mm, 8 mm, 10 mm, 12 mm, 14
mm, 15 mm, 20 mm, or 25 mm. The openings may be placed over the
lesion or disorder to determine the size of the lesion or skin
disorder. As shown in FIG. 3, the measuring grid may also be
utilized to measure the height of a lesion. For example, the holes
in the grid may include markings that permit measuring the height.
The grid may be placed on the lesion and the depth viewed from the
side, if the grid is made of a clear material, or by viewing how
far the lesion extends up the side of an opening.
[0028] Once the size of the lesion or other skin disorder is
determined, the correct size injection guide and depth may be
secured to the auto-injector or auto-injector including a correct
sized injection guide may be selected. The auto-injector may then
be positioned over the lesion and the injection carried out.
Placing the measuring grid on the lesion for diameter will
determine the dose. Table 1 below provides examples of diagnoses,
the type of process that results in the lesion, and how depth and
dose are determined.
TABLE-US-00001 TABLE 1 Type of Dose Depth Process (determined
(determined (Lesion or by Diameter by Height DIAGNOSIS Disorder) or
Provider) or Provider) Acne Cysts Lesion Diameter Height Inflamed
Sebaceous Cyst Lesion Diameter Height Bug Bites Lesion Diameter
Height Alopecia Areata Disorder Provider Provider Hypertrophic
Scars Disorder Provider Provider Keloids Disorder Provider Provider
Psoriasis Disorder Provider Provider Granuloma Annulare Disorder
Provider Provider Discoid Lupus Erythematosus Disorder Provider
Provider Hypertrophic Lichen Planus Disorder Provider Provider
Lichen Planopilaris Disorder Provider Provider Lichen Simplex
Chronicus Disorder Provider Provider Erythema Nodosum Disorder
Provider Provider Sarcoidosis Lesion Diameter Height Prurigo
Nodularis Lesion Diameter Height
[0029] Evaluation of a disorder for proper dose and depth of
medicant may be determined by a healthcare provider, such as a
physician, physician assistant, or nurse practitioner. A disorder
of the skin may be treated intralesionally (in the lesion) or
intradermally (in the skin). That is, if the inflammation is in the
dermis the treatment will be intradermally. On the other hand, if
the inflammation is above the level of the skin then the treatment
will be intralesionally. The provider may determine the thickness
and body area of an inflammatory skin disorder and then choose the
proper depth and dose of the medicant. Thickness of the dermis
varies from about 0.6 mm to about 3 mm, depending on the body area.
The face has the thinnest dermis (0.6 mm) and the back has the
thickest dermis (3 mm).
[0030] FIG. 4 illustrates an embodiment of an auto-injector that
the patient may utilize to treat the lesion or other skin disorder.
Embodiments of an auto-injector 100 typically include a syringe 1.
The syringe 1 has a first end 3 and second end 5 and an interior
wall 7 and exterior wall 9. The syringe 1 typically includes a
space 11 that houses a medicine 13 to be administered. The medicine
may be contained by the interior wall 7 of the syringe 1 and other
structures described below. Alternatively, the medicine 13 may be
contained within a vial 15 arranged in the space 11.
[0031] A variety of medicines may be utilized to treat various
lesions and skin disorders. For example, an inflamed lesion or
other skin disorder may be treated with a solution of and/or a
suspension of triamcinolone acetonide (TAC). The strength of the
solution may vary depending on the condition and the size of the
lesion, among other factors. Typically, the strength of the TAC
solution may range from about 2 mg/cc to about 40 mg/cc. Naturally,
other medicines may be administered to treat various other
dermatological conditions. Additionally, different conditions may
require different treatments with other medicines intralesionally.
For example, bleomycin may be administered intralesionally to treat
viral warts, vascular anomalies, basal cell carcinoma,
karatoacanthomas, Kaposi's sarcoma, squamous cell carcinoma, and
cutaneous leishmaniasis. Additionally, 5-fluorouaracil may be
administered intralesionally to treat keloids and squamous cell
carcinoma. Furthermore, methotrexate may be administered
intralesionally to treat keratoacanthomas. Also, chloroquine may be
administered intralesionally to treat chronic discoid lupus
erythematosus and sarcoidosis. Still further, interferon may be
administered intralesionally to treat lentigo maligna, Peyronie's
disease, genital warts, keratoacanthomas and basal cell carcinomas.
These are just a few examples of a few conditions and treatment
with which the auto-injector may be utilized.
[0032] The size of the vial or space to contain medicine may vary,
depending upon if the auto-injector is for treating multiple cysts
or for carrying out multiple treatments. Along these lines, a
single use auto-injector may include a smaller vial or space. An
auto-injector may be refillable or the vial replaceable so that the
space for medicine or vial need not necessarily be large. An
auto-injector for treating multiple lesions or skin disorders may
have a larger space for medicine or vial. The range of the amount
of TAC solution would be between about 0.1 cc to about 0.5 cc of
solution. Other medicants may also be delivered intralesionally.
Such medicants may include bleomycin, 5-fluorouracil, methotrexate,
chloroquine and interferon. Other conditions that may be treated
can include viral warts, keloids, keratoacanthomas and discoid
lupus erythematosus. The range of solution that is injected to
treat these other conditions may range from about 0.1 cc to about 2
cc administered per treatment.
[0033] A needle 17 for delivery of medicine may be arranged at the
second end 5 of the syringe 1. The needle 17 may be replaceable or
fixed in place. For example, the needle 17 could be similar to a
typical needle assembly in a syringe. Alternatively, the needle
could be fixed to a cap that is connected to the syringe. Along
these lines, the cap could be attached to the syringe with a
threaded connection or another connection that could make the cap
and needle removable and replaceable. The cap could be permanently
adhered to the syringe.
[0034] In a disposable auto-injector, the needle and/or cap is
typically permanently attached to the syringe. On the other hand,
in a reusable auto-injector, the needle and/or needle assembly
including the cap may be replaceable. Some embodiments may include
a retractable needle. Such embodiments may be disposable or
reusable.
[0035] The size of the needle typically is sufficient to carry out
an intralesional or intradermal injection. This typically will
result in the injection of the medicine directly into the lesion or
other skin condition. An intramuscular injection, such as carried
out for administering a vaccine, is carried out deeper in the skin.
Typically, the auto-injector may administer a dose of medicine at a
depth of about 3 mm or less. More typically, the auto-injector is
configured to administer a dose at a depth of about 1 mm to about 3
mm. Depending on the condition and body area, the healthcare
provider may help choose the proper depth on the auto-injector.
[0036] Since the patient will carry out the injection, it is
important that the needle length be such that the medicine will be
correctly administered. The length of the needle is typically from
about 4 mm to about 12 mm.
[0037] The needle has a thickness, or gauge, to maximize patient
comfort. Along these lines, the needle may have a gauge of about 32
to about 34. According to one embodiment, the needle is a 34 gauge
needle.
[0038] To facilitate injection of the medicine in the proper
location, the auto-injector may include an injection guide 29, an
embodiment of which is shown in FIG. 4. The guide extends from the
second end 5 of the syringe 1 at least as far as the needle.
Typically, the guide may extend farther from the second end of the
syringe than the needle. The injection guide may extend a distance
from the second end of the syringe sufficient to prevent contact of
the needle with the skin prior to injection.
[0039] The injection guide may help to center the needle over the
lesion or other skin disorders prior to injection. Thus, the
injection guide may have a round shape. The injection guide may be
visually arranged about the perimeter of the lesion or other skin
condition and then the injection carried out. The injection guide
could have an inner diameter of from about 6 mm to about 10 mm. The
size of the injection guide may differ to treat different size
lesions or other skin disorders. For example, to treat a small
lesion or other skin disorder, the injection guide may have a
diameter of about 6 mm. An injection guide having a diameter of
about 8mm may be used to treat a medium size lesion or disorder.
For a large lesion or disorder the injection guide may have an
inner diameter of about 10 mm. The size of the diameter of the
inner wall of the injection guide may be smaller or larger than the
dimensions discussed herein.
[0040] The injection guide could be formed with the syringe.
Alternatively, the injection guide could be permanently or
replaceably attached to the second end of the syringe. As such,
auto-injectors may be produced having different sized injection
guides.
[0041] To increase the flexibility of the auto-injector, the
injection guide may be replaceable or adjustable. Along these
lines, the injection guide may be attachable to the syringe with a
connection that permits the injection guide to be removed. The
connection could include threads, tabs and guides, indents and
protuberances or any other connection that permits changing the
injection guide. The guide could also be adjustable, such as
including interweaving leaves that can be opened up or closed
together, such as a camera diaphragm. A replaceable or adjustable
injection guide could have the diameters discussed above.
[0042] To carry out the injection, the auto-injector may include a
plunger 19 or other structure configured to apply force to the
medicine in the syringe or vial through the needle and into the
patient. The plunger may be similar to a typical syringe plunger.
The plunger is typically arranged in the vicinity of the first end
3 of the syringe 1.
[0043] To further customize the auto-injector to provide the most
appropriate treatment, the auto-injector may include a selection
assembly 21 configured to vary the amount of medicine administered
by the auto-injector. The selection assembly 21 may vary the
distance that the plunger is advanced and/or vary the amount of
medicine administered. The selection assembly may alternatively
alter the position at which the plunger is arranged prior to
commencing the administration of medicine. Along these lines, prior
to placing the auto-injector the plunger may be positioned in the
desired position. This may cause some medicine to be ejected from
the needle. The selection assembly may alternatively limit depth to
which the plunger moves into the syringe during administration of
the medicine. The injection may then be carried out.
[0044] The embodiment of the selection assembly shown in FIG. 4
includes three dose selectors 23, 25 and 27 configured to
administer large, medium and small doses to correspondingly sized
lesions or other skin disorders. The embodiment also includes three
depth selectors 35, 37, and 39 configured to control the depth to
which the needle will extend during administration of the medicine.
The dose and depth selectors may be arranged on a side of the
auto-injector. The dose selectors in this embodiment may be
interconnected with the plunger to control the dose by controlling
the depth to which the plunger advances. The depth selector may
also control the depth to which the plunger advances. Typical
dosage sizes are discussed above. The auto-injector may be
configured to permit selection among any therapeutically effective
dose or amount. Table 2 below provided examples of diameter of
lesions, dose and which lever is actuated.
TABLE-US-00002 TABLE 2 Diameter Guide Diameter Size Lesion Dose
Button Less than 6 mm 0.01 cc TAC S (Small Dose) Between 6-10 mm
0.02 cc TAC M (Medium Dose) Greater than 10 mm 0.03 cc TAC L (Large
Dose)
[0045] Additionally, the auto-injector may be configured to control
the depth to which the injection is made. As with the dose size,
the depth to which the dose is delivered may depend upon the size
of the lesion. The depth could be, for example, from about 1 mm to
about 3 mm. The dose of medicine could be delivered at other
depths. The embodiment shown in FIG. 4 includes three selectors
configured to control the depth to which the medicine is delivered.
For example, the selectors could permit arrangement of the needle
to administer the medicine at about 1 mm, about 2 mm, or about 3
mm. The depth of delivery could be determined utilizing a measuring
grid or by a healthcare provider. There may be one or more
structures connecting the plunger to each or all of the
selectors.
[0046] The height of the lesion may be extrapolated from measuring
the diameter of the lesion. For example, a relationship between the
diameter determined with the measuring grid on the lesion for
height will determine the depth as shown in Table 3 below.
TABLE-US-00003 TABLE 3 Height Guide Height Lesion Depth Button Less
than 2 mm 1 mm Deep 1 Between 2-3 mm 2 mm Deep 2 Greater than 3 mm
3 mm Deep 3
[0047] Alternatively, an actuator could be attached to the end of
the plunger, similar to a traditional syringe. One or more levers
could act as a stop to prevent the plunger from moving beyond a
certain point. This would control the amount of medicine forced out
of the auto-injector by the plunger.
[0048] Some embodiments may include a spring 41 configured to
actuate the plunger to administer the medicine. The spring may bias
the plunger, vial and needle upward as shown in FIG. 4 such that
the needle is concealed within the syringe when not in use. The
plunger will act against the spring during administration of the
medicine.
[0049] The size of the dose may depend upon the medicine,
concentration of medicine, condition being treated, size of a
lesion, among other factors. The auto-injector may be configured to
administer doses of from about 0.01 cc to about 0.03 cc. To treat
an inflamed skin lesion, the auto-injector could be configured to
administer about 0.01 cc to a small lesion, about 0.02 cc to a
medium lesion or about 0.03 cc to a large lesion. Other amounts
could also be administered.
[0050] The depth to which the medicine is administered may also be
varied. This could be accomplished by varying the length of the
injection guide and/or varying the length of the needle, for
example. As described above and shown in FIG. 4, depth selectors
may be included to control a depth to which the plunger may advance
and, thus, the depth to which the needle advances from the syringe.
Also, depending on the condition being treated, the height of the
lesion, and the location on the body the patient can determine the
proper depth or a healthcare provider will instruct the patient as
to a proper depth.
[0051] FIG. 6 illustrates another embodiment of an auto-injector
100. The auto-injector shown in FIG. 6 includes a forward housing
element 102 and a rear housing element 104. The forward housing
element contains the medicine to be administered and the rear
housing the user actuated administration mechanism. The two housing
elements may be connected together with a threaded connection 106
and 108. According to some embodiments, the housing elements may be
integral or other connections may be utilized. One advantage of a
separable connection, such as a threaded connection is that the
medicine, needle and other elements may be replaceable.
[0052] A first end of the forward housing element includes a depth
selector 110. The embodiment of the depth selector shown in FIG. 6
may be rotated to change the extent to which the needle 120 extends
from the auto-injector. The embodiment of the depth selector shown
in FIG. 6 is connected to the forward housing with a threaded
connection 112 and 114. Other connections may also be utilized. A
separable connection may be advantageous to permit replacement of
the needle.
[0053] Indicators 116 on the forward housing and 118 on the depth
selector permit the user to select the depth to which the needle
120 will penetrate the user's skin. The embodiment of the depth
selector shown in FIG. 6 permits the needle to be adjusted to three
depths. The depth selector and/or the forward housing may include
one or more detents and complementary protrusions or other elements
to indicate when a certain depth has been selected and/or to
maintain the depth selector and needle in the selected
position.
[0054] The needle 120 may be part of a needle assembly including a
needle base 122 in which the needle may be anchored. A needle guide
124 may be included to guide the needle during administration. The
needle guide may also help to prevent bending of the needle during
administration, particularly as the needle penetrates the skin.
Along these lines, the needle guide may include a tip 126 having an
inner diameter slightly wider than the exterior diameter of the
needle.
[0055] The adjustment of the depth with the depth adjuster may
advance the needle guide. Along these lines, the exterior surface
of the needle guide may abut the interior of the depth adjuster or
the passage 103 in the depth adjuster. If the depth selector is
attached to the housing with a threaded connection, as the depth
adjuster is screwed or unscrewed, the distance between the distance
selector and housing may decrease or increase, respectively. This
may advance and withdraw the needle guide and, hence, the
needle.
[0056] In the embodiment shown in FIGS. 6 and 7, the forward
housing 102 contains the medicine vial 128. The vial may include a
threaded connection 130 for connecting the needle base to the vial.
The housing 102 may include a cut out or window 131 to facilitate a
visual determination of the amount of medicine in the vial.
[0057] The end of the rear housing includes a dosage adjuster 132.
The dosage adjuster includes indicators 134 to select a dosage. The
dosage selected is indicated by an arrow 138 on the housing. The
dosage adjuster is connected to a drive sleeve 140. The drive
sleeve includes a ratchet mechanism 142 that only permits rotation
in one direction with respect to reset ring 152. Each click of the
ratchet mechanism corresponds to an increase in the dosage.
[0058] Torque is applied to a spring 144 as the dosage adjuster is
turned. Spring 144 is secured to drive sleeve 140 with a spring
holder 146. The spring holder engages the end of the spring and
abuts the ratchet mechanism 142, thereby permitting torque to be
applied to the spring 144. On the other hand, spring 156 maintains
a forward force on the plunger, vial and needle. Guide 154 may
include a guide leg 154a that can slide in slots in the reset ring
152.
[0059] Once the desired dose is selected and the springs and other
elements set, actuator 150 is pressed by the user. Actuation
releases the springs and other elements such that the desired
dosage is delivered from the vial at the depth selected with the
depth selector.
[0060] Once the user has selected the desired dose the user places
the needle into user's skin and presses down on the actuator 150.
The actuator releases the ratchet mechanism and allows the ratchet
mechanism to rotate. This rotational energy is provided by the
torsion spring 144. Rotation caused by the spring 144 ultimately
causes the plunger 160 to advance through the medicine vial,
thereby dispensing the medicine. As the threaded plunger 160
advances, a complementarily threaded nut 158 advances on the
threaded plunger. When the threaded nut reaches the end of the
threaded plunger, the dosage selector cannot be spun any further,
indicating that the amount of medicine remaining in the vial is
what is displayed on the dial. This may prevent accidental under
dosing.
[0061] To facilitate treatment, the auto-injector may be included
in a treatment kit 161, an embodiment of which is shown in FIG. 10.
The kit may include an antiseptic wipe or swab 162 for disinfecting
the injection site. The antiseptic wipe could be made of a woven or
unwoven material, such as fabric gauze or a paper. The wipe could
include any suitable antiseptic material, such as alcohol or an
antibacterial substance. The wipe or swab may be packaged
separately. The kit may also include the auto-injector 100, as
described herein. Additionally, the kit may include an antiseptic
wipe or swab 164 to treat the injection site after the injection.
Treating the injection site after the injection may help to prevent
bacteria from entering the injection site and remove any blood, pus
or other fluids leaking from the injection site. Furthermore, the
kit may include a bandage 166 to cover the injection site.
[0062] A housing or enclosure could contain all of the elements of
the kit. The housing could also receive the auto-injector and any
wipes after use, facilitating disposal of the elements of the kit.
Along these lines, the auto-injector may be considered medical
waste, which requires a particular disposal method. The housing
could include a seal to maintain the elements of the kit in a
sterile condition. The auto-injector alone may additionally or
alternatively include its own seal or enclosure or housing, whether
included in a kit or on its own. The seal on a kit or the
auto-injector may be breached to gain access to the elements of the
kit or the auto-injector. The enclosure may include a simple wrap
about the auto-injector alone together with other possible elements
of the kit. Each element of the kit may include a separate housing,
enclosure, wrapping or packaging. The housing or enclosure may
include one or more closure or sealing elements to close the
housing or enclosure after carrying out an injection and placing
the used elements of the kit back into the housing or
enclosure.
[0063] Typically, use of the kit includes opening the housing,
enclosure, wrapping or packaging. If the kit includes a
pre-injection wipe, then the wipe may be retrieved from any
housing, enclosure, wrapping or packaging and the potential
injection site cleaned. The auto-injector may be removed from any
housing, enclosure, wrapping or packaging and configured for
injection as described above. The injection may then be carried
out. A post-injection wipe may be retrieved from any housing,
enclosure, wrapping or packaging and the injection site cleaned.
The auto-injector and wipes may be disposed of. According to some
embodiments, the auto-injector and possibly a pre-injection and/or
post injection wipe may be reintroduced into a housing, enclosure,
wrapping or packaging, the housing, enclosure, wrapping or
packaging closed and the used auto-injector and possibly wipes
disposed of, such as in a "sharps" or other medical waste
container.
[0064] The foregoing description of the invention illustrates and
describes the present invention. Additionally, the disclosure shows
and describes only the preferred embodiments of the invention, but
as aforementioned, it is to be understood that the invention is
capable of use in various other combinations, modifications, and
environments and is capable of changes or modifications within the
scope of the inventive concept as expressed herein, commensurate
with the above teachings, and/or the skill or knowledge of the
relevant art. The embodiments described hereinabove are further
intended to explain best modes known of practicing the invention
and to enable others skilled in the art to utilize the invention in
such, or other, embodiments and with the various modifications
required by the particular applications or uses of the invention.
Accordingly, the description is not intended to limit the invention
to the form disclosed herein. Also, it is intended that the
appended claims be construed to include alternative
embodiments.
* * * * *