U.S. patent application number 14/480359 was filed with the patent office on 2014-12-25 for drug delivery device.
The applicant listed for this patent is Insuline Medical, Ltd.. Invention is credited to Gabriel Bitton, Ron Nagar, Benny Pesach, Ram Weiss.
Application Number | 20140378908 14/480359 |
Document ID | / |
Family ID | 39684452 |
Filed Date | 2014-12-25 |
United States Patent
Application |
20140378908 |
Kind Code |
A1 |
Pesach; Benny ; et
al. |
December 25, 2014 |
DRUG DELIVERY DEVICE
Abstract
The present disclosure presents systems, devices and methods for
injection of drugs, substances and/or chemicals to a patient and
for improving their effectiveness once they are injected are
disclosed. Additional treatment can be applied to a tissue region
on the patient into which a drug (e.g., insulin) is injected, to
expose the tissue region to various forms of energy or a substance
to improve the drug's pharmacokinetic and/or pharmacodynamic
profile.
Inventors: |
Pesach; Benny; (Rosh-ha
ayin, IL) ; Bitton; Gabriel; (Jerusalem, IL) ;
Weiss; Ram; (Haifa, IL) ; Nagar; Ron; (Tel
Aviv, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Insuline Medical, Ltd. |
Petach-Tikva |
|
IL |
|
|
Family ID: |
39684452 |
Appl. No.: |
14/480359 |
Filed: |
September 8, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12450251 |
Jan 15, 2010 |
8827979 |
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PCT/IB2008/051049 |
Mar 19, 2008 |
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14480359 |
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11821230 |
Jun 21, 2007 |
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12450251 |
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60895518 |
Mar 19, 2007 |
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60895519 |
Mar 19, 2007 |
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60912698 |
Apr 19, 2007 |
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60940721 |
May 30, 2007 |
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61008277 |
Dec 18, 2007 |
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61016571 |
Dec 25, 2007 |
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61010758 |
Jan 10, 2008 |
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Current U.S.
Class: |
604/187 |
Current CPC
Class: |
A61M 5/14244 20130101;
A61M 2205/05 20130101; A61M 2205/052 20130101; A61N 7/00 20130101;
A61B 2018/1425 20130101; A61F 7/007 20130101; A61B 18/1477
20130101; A61M 5/158 20130101; A61M 5/19 20130101; A61M 2005/1581
20130101; A61M 2205/051 20130101; A61M 5/16831 20130101; A61M
2005/1726 20130101; A61N 2005/0645 20130101; A61M 5/20 20130101;
A61N 1/30 20130101; A61M 2205/058 20130101; A61M 5/31 20130101;
A61B 18/14 20130101; A61M 2205/054 20130101; A61B 18/08 20130101;
A61B 18/18 20130101; A61B 18/20 20130101; A61M 5/1723 20130101;
A61M 5/422 20130101; A61M 5/2448 20130101; A61M 2205/057
20130101 |
Class at
Publication: |
604/187 |
International
Class: |
A61M 5/31 20060101
A61M005/31; A61M 5/24 20060101 A61M005/24 |
Claims
1. An apparatus for delivering therapeutic fluid to a patient at an
injection site, comprising: a fluid injection device having a
housing, wherein said housing contains: an injector for injecting
the therapeutic fluid to the injection site; and a reservoir for
containing the therapeutic fluid; a treatment element coupled to
said fluid injection device and configured to apply treatment to
the injection site; wherein said treatment element is further
configured to improve pharmacokinetic and/or pharmacodynamics
property of the therapeutic fluid.
2-80. (canceled)
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] The present invention claims priority to U.S. Provisional
Patent Application No. 60/895,518, filed Mar. 19, 2007, U.S.
Provisional Patent Application Ser. No. 60/895,519, filed Mar. 19,
2007, U.S. Provisional Patent Application Ser. No. 60/912,698,
filed Apr. 19, 2007, U.S. Provisional Patent Application Ser. No.
60/940,721, filed May 30, 2007, U.S. Provisional Patent Application
No. 61/016,571, filed Dec. 25, 2007, U.S. Provisional Patent
Application No. 61/008,277, filed Dec. 18, 2007 and U.S.
Provisional Patent Application No. 61/010,758, field Jan. 10, 2008,
and U.S. patent application Ser. No. 11/812,230, filed Jun. 21,
2007, the disclosures of which are incorporated herein by reference
in their entireties.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to systems and methods for
delivering drugs to a patient. In particular, the present invention
relates to systems and methods for subcutaneous injection of a
medicament and using one or more treatment sources to improve
effectiveness of the injected drugs.
[0004] 2. Background of the Invention
[0005] Pen injectors are useful when regular injection by persons
without formal medical training occurs. This is increasingly common
amongst those having chronic conditions such as diabetes where
self-treatment enables such persons effectively manage their
condition. Many of the insulin pen injectors are reusable and
usually loaded with an insulin cartridge that may be used for a
plurality of injections or for a number of days. Many other
diabetic patients use regular syringe(s) and needles for insulin
injection.
[0006] Diabetes is a very serious illness affecting millions of
people today. Many diabetic patients require injections of insulin
to maintain proper levels of glucose in their blood in order to
survive. Such injections of insulin require drug injection
systems.
[0007] Many medical treatment systems and methods involve drug
injection systems that employ subcutaneous injections of
therapeutic fluids, drugs, proteins, and other compounds. Such
delivery systems and methods, especially for insulin delivery, may
use injection pens to inject insulin to the subcutaneous tissue, or
regular syringe. In the conventional insulin injection pens, the
pen includes a disposable insulin reservoir and a disposable needle
through which insulin is injected into the tissue. The needle is a
single use needle, while the insulin reservoir can be used for two
to three days. In the conventional insulin injection pens, the
injection is done by attaching the insulin injection pen to the
skin at the injection site and pressing a button that first insert
the needle using a spring into the subcutaneous tissue and then
inject the insulin to the subcutaneous tissue.
[0008] In many instances, the patients require insulin injection
around the clock to keep proper levels of glucose in their blood.
Two major types of insulin can be injected--a long-acting insulin
that provides the basal insulin rate needed for keeping patient's
blood glucose in the desired range between meals and over night and
an insulin bolus injection that provides an amount of insulin for
matching a dose of carbohydrates consumed by the patient.
[0009] When patient consumes food, his or her levels of glucose
rise. Unfortunately, many conventional subcutaneous injection
devices are incapable of quickly matching and/or preventing the
rise of blood glucose. The delay in such matching is also true in
case of the "rapid-acting" insulin. Some of the reasons for this
delay include a lag in the absorption of insulin from the injection
site and the time it takes for complex insulin molecules to break
down into monomers.
[0010] Additionally, since blood glucose levels rise shortly
following the meal, the delay in matching insulin to the rising
levels causes post prandial hyperglycemic events (i.e., when levels
of blood glucose are above normal) to occur. Occasionally, after
certain period of time passes (e.g., 2-3 hours) after the meal, the
blood glucose levels drop yet insulin concentrations in the blood
rise followed by the peak of the systemic insulin effect and may
result in causing hypoglycemic events (i.e., when levels of blood
glucose are below normal) to occur. Both hyperglycemic and
hypoglycemic events are highly undesirable. Additionally, since
local blood perfusion at the insulin injection region has large
variability, depending on the ambient temperature and other
parameters, it induces large variations to the delay of the peak of
time profile of the insulin action. Those variations in the insulin
peak action period further increase the variability in the blood
glucose level.
[0011] Thus, it is desirable to provide a system and a method that
provides efficient and rapid injection and absorption of the drug
to the patient circulatory system. In particular, it is desirable
to provide a system and a method for injection of insulin to the
patient that improves effectiveness of insulin in the blood to
maintain normal levels of blood glucose and prevent or reduce
hyperglycemic and hypoglycemic events.
SUMMARY OF THE INVENTION
[0012] The present invention relate to systems, devices and methods
for injecting a drug, substances and/or chemicals to a patient that
further provides a tissue treatment element for improving the
effectiveness of drug delivery upon injection. In some embodiments,
the present invention relates to a device for improving performance
of drug delivery in the form of injection pens or syringes. In
general, the present invention's suggested methods and devices can
be used in many drug injection devices, such as injection pen(s),
syringe(s), or jet injector(s), or other injection devices. As
such, although the present application discusses mainly injection
pens, it is understood by one skilled in the art that such devices
can be used with any other injection devices. In some embodiments,
the present invention provides for a device that further provides
an additional treatment to a tissue region where the drug is
delivered. In some embodiments, the treatment is utilized to
improve drug delivery process by improving the drug's
pharmacokinetic and/or pharmacodynamic profile. The treatment may
come in various forms, for example, including analgesic,
vasodilator or the like. The treatment may be any form of treatment
that leads to improved vasodilatation of the tissue being injected,
including but not limited to, exposing the tissue region to an
energy, radiation, heat, mechanical vibrations, suction, massaging,
acoustic stimulation, electromagnetic radiation, electric field,
magnetic field, electrical stimulation, injection of an additional
substance(s), or any combination of the above to improve the drug's
pharmacokinetic and/or pharmacodynamic profile. Each treatment type
may have a separate protocol in order to evoke the necessary
reaction such as vasodilatation or the like.
[0013] In some embodiments, the present invention provides a needle
free drug delivery pen that is coupled to a treatment element. The
treatment element improves the pharmacokinetic and/or
pharmacodynamic properties of the drug that is being delivered to
the target tissue using a fluid jet. The drug delivery injector for
administering a drug, for example, insulin, as a jet nozzle
configured for firing insulin in a fluid jet in a configuration and
with sufficient velocity to penetrate tissue of the patient to a
delivery site. A drug containing compartment is associated with the
nozzle for containing the drug and feeding the insulin to the
delivery nozzle for injection. A firing mechanism includes an
energy source is associated with the drug compartment for forcing
the drug through the nozzle at a sufficient velocity to penetrate
to the target site. In some embodiments, the energy source
producing the fluid jet can be a coil spring, gas spring, or any
other spring. A trigger or a dosage release button of the drug
delivery injector is movable by the user and associated with the
firing mechanism for activating the energy source that produces the
drug fluid jet by forcing of the drug through the nozzle once the
release button is activated.
[0014] In some embodiments, the applied treatment induces
vasodilatation through neural stimulation of the tissue of the drug
injection site. The neural stimulation can be induced by thermal
stimulation and/or mechanical stimulation and/or chemical
stimulation. The human neural response to the thermal stimulation
includes several mechanisms such as the Nociceptive Axon Reflex
that induce vasodilatation among other effects.
[0015] In some embodiments, the induced neural response, such as
the Nociceptive Axon Reflex, also induces widening of the capillary
pores and increasing the capillary wall permeability. This effect
is also significant for improving the absorption of the drag
through the capillary wall.
[0016] In some embodiments, the applied treatment may lead to a
reduction in the variability of the drug absorption in the blood or
lymph system and its local and systemic effects. For example,
heating the tissue region in the vicinity of the area of drug
delivery to a preset regulated temperature during and/or after the
drug injection and absorption into the blood may cause local blood
perfusion at that region to become more reproducible and the drug
absorption process more uniform and reproducible as well. Also, by
reducing the delay between drug injection into the tissue and
absorption into the blood system, the variability of drug action
induced by the delayed profile can be reduced. In some embodiments,
the temperature of the region adjacent to the injection region can
be regulated for longer periods, but the cost may be the energy
source volume and weight. Therefore, for minimization of the energy
source size, the heating period or heating temporal profile can be
optimized in relation to the period of the drug injection and
absorption into the blood. In some embodiments, in which the
treatment utilized is, for example, heat, the drug interaction with
the treatment substance or type will be taken into consideration
and can be avoided. For example, a drug's temperature sensitivity
will be accounted for so as to avoid protein denaturisation.
Insulin is a temperature-sensitive protein and to avoid damage to
the insulin the treatment protocol, heating can be limited to
ensure the efficacy of the delivered drug. For example, the
treatment protocol may control the temperature or the location of
the treatment delivery site so as to not damage the drug.
[0017] In some embodiments, the neural response that induces
vasodilatation is stimulated by applying a mechanical force in the
vicinity of the drug infused region, wherein the force includes,
but is not limited to, one or more of the following: pressure,
massage, vibration, suction and/or any other mechanical
stimulation. These tissue treatments or stimulations are known to
stimulate the Nociceptive Axon Reflex as well. Among the advantages
of the mechanical stimulation is the fact that it does not damage
the drug, whereas for example heating insulin above 37.degree. C.
may cause damage to it. The calibration of the applied mechanical
force may be performed by using one of the procedures discussed
above.
[0018] In some embodiments, an additional fluid substance can be
combined with the drug or, alternatively, injected, infused, or
topically applied (which may include transdermal delivery of the
drug by permeating through the skin of the patient) to the drug
injection site, such that the additional substance induces neural
stimulation that leads to local vasodilatation and/or increases of
the capillary permeability. The substances can include tolazine,
naftidrofuryl, suloctidil, nitroprusside, capsaicin, or any other
suitable substance. In some embodiments, an additional substance
may induce vasodilatation and improve blood perfusion in the drug
infused tissue region. For example, capsaicin stimulates a neural
response through the VR1 receptor and produces a similar response
to thermal neural stimulation.
[0019] The treatment element can be an integral part of the drug
delivery injection pen, according to some embodiments of the
present invention. In some embodiments, the treatment element can
be an auxiliary unit that may be interchanged, replaced, or added
to an existing drug delivery injection pen. Such a device can be
attached to the drug delivery pen either during or before the drug
injection or applied to the drug injection site afterward.
[0020] The treatment element, according to some embodiments, may be
any one or more of (or a combination of): a heating element, a
radiation emitter, a sound transducer, a
mechanical/electo-mechanical vibration device, a light emitting
device, and an electrode.
[0021] In some embodiments, one or more of properties relating to
the treatment element may be controlled by a processor in order to
achieve a desired response of the tissue region undergoing drug
delivery. Such properties include amplitude, phase, frequency,
combination of excitation sources, relative ratio and timing
between various excitation sources, or any other properties. In
some embodiments, the treatment type or sources can be also
adjusted according to chemical and/or physical properties of the
drug being delivered. The tissue response to the treatment
element/stimulation enhances the functionality of the injected drug
by enhancing the kinetics of molecular transport from the injection
site inside the tissue to various compartments surrounding the
tissue region and to the blood system.
[0022] In some embodiments, a treatment element or device supplying
tissue treatment or stimulation to a tissue region can be
configured to monitor and control properties of the treatment
source. For example, controllable properties of a treatment
protocol include amplitude, phase, intensity, frequency, or any
other properties. Further control can be gained by actively
monitoring, such that the information is provided to a controller
("controller" or "processing unit") that uses the information to
reduce the variability of the drug pharmacokinetics. In such
embodiments, the device can be configured to monitor properties of
the adjacent tissue, such as local blood perfusion or skin
temperature. Based on such monitoring, the information can be
provided to the controller that utilizes the information to improve
pharmacokinetic or pharmacodynamic profile of the drug as well as
its performance and reduce variability of the drug injection
process.
[0023] In some embodiments, the present invention's device includes
a sensor or other triggering input mechanism that is configured to
prevent deployment of the drug delivery pen unless certain criteria
are fulfilled. Such criteria can include activation of a treatment
protocol or element.
[0024] In some embodiments, tissue treatment can be applied
simultaneously with each injection of the drug delivery. In other
embodiments, the tissue treatment or stimulation option may be
selected manually by the user. In some embodiments, the user may
choose to attach the treatment element to the drug delivery pen.
The user can enable or disable mechanically the automatic
application of treatment element. The user can activate the
treatment device or devices before or after the drug injection to
enhance the tissue response to the injected drug. Such activation
can be done by pressing a button or a sequence of buttons on the
drug delivery pen.
[0025] For example, in case of an insulin delivery pen, the pen may
have a special button for triggering a "fast bolus" as compared to
regular bolus injection provided by the drug delivery injection
pen. The fast insulin bolus mode can be configured to start one of
the above treatments parallel to the injection of insulin or short
time before or after the injection of the insulin bolus for a given
period of time. This improves or modifies pharmacokinetics or
pharmacodynamics of insulin administration, tissue blood perfusion
and/or absorption in the blood of a patient and is highly
advantageous when applied in conjunction with high glycemic index
foods. Application of a "fast bolus" may be useful for consumption
of high glycemic index foods, where larger rapid glucose excursions
occurs, but also in most of the cases of using insulin boluses for
prandial coverage. In some embodiments, application of a "fast
bolus" can be set as the default mode of the drug delivery pen. In
some embodiments, the user may apply the tissue treatment or
stimulation before the meal to further increase the treatment
effect.
[0026] In some embodiments, at least one effect of the treatments
is to reduce local irritation caused by the infused drug or local
inflammation reaction caused by the injection. For example, in case
of insulin injection, reducing the period in which the high
concentration of insulin remains in the tissue may reduce
irritation that may be caused by insulin. It can also reduce
unwanted effects of the insulin delivery, such as,
lipohypertrophy.
[0027] Some embodiments of the present invention also provide
methods for improving or modifying a drug's pharmacokinetic or
pharmacodynamic profile in order to reduce time to peak action in
the blood of the injected material by applying a modulation pattern
to the infused drug. With this modulation, the injection drug fluid
is slightly moved/pulled in and out of the tissue during or after
the drug injection process. In such embodiments, this method may
not require an additional device applied to the skin.
[0028] In some embodiments, the drug delivery pen can mechanically
attach a small disposable device to the skin either before, during
or after delivery of the drug. The disposable device can apply a
treatment or treatments using at least one of the following
sources: a heat source (such as a heat resistor), a suction port,
for example activated by a pump, a mechanical vibration source, an
ultrasound excitation source, an ultrasound transducer, a light
source, a massaging element, electromagnetic radiation source,
electric field source, magnetic field source, additional substance
and/or a combination of at least two of sources to improve drug
pharmacokinetics. In some embodiments, the small disposable device
can be attached manually either before or after injection of the
drug.
[0029] In some embodiments, a device for drug injection includes a
disposable injection needle for injecting drug into tissue, a
reusable drug delivery pen for inserting the needle into the
patient skin or subcutaneous layer and for injection of the drug
through the needle into one of the skin and/or subcutaneous tissue
layer, a treatment device for applying a specific treatment or
stimulation to the drug injected region in order to improve drug's
pharmacokinetic, pharmacodynamic profile and/or to increase blood
perfusion in that region before, during and/or after the drug
injection period to improve drug absorption into the blood system.
The needle can be injected automatically at the target site using
an automatic needle triggering piston or spring. In some
embodiments, the needle can be injected at the target site manually
through the action of the user inserting the needle
independently.
[0030] In some embodiments, a device for drug injection includes an
injection catheter for insertion into the tissue, a drug injection
device for infusing a drug into the injection catheter, a treatment
device for applying a specific treatment or stimulation to the drug
infused region in order to improve, modify and/or stabilize the
drug pharmacokinetics, pharmacodynamics, and/or to reduce
variations of the drug absorption into the blood system.
[0031] In some embodiments, a device for drug injection includes at
least one of the following: a display, a button, a memory for
boluses, a processing unit, a sensor for skin properties, a sensor
for treatment level, a glucose sensor, a user interface, wireless
connection to a PDA or cell phone for having memory and reminders
and remote access to support sites.
[0032] In some embodiments, the device for drug/insulin injection
includes a glucose sensor. The glucose sensor may measure blood
glucose level at alternate sites (for example, at sites with
reduced blood perfusion, such as arms and legs). The glucose sensor
can be provided on the opposite side the injection end.
[0033] In some embodiments, the present invention can be configured
for a jet injection. Jet injection involves high pressure injection
of material, which obviates the use of needles. This type of
injection mode is also referred to as "needle free" or "needleless"
injection. In some embodiments, the pen injection device can
include a jet injection, in addition to or in place of, the use of
one or more needles. Some examples of conventional needle-free
injection systems include the Medi-Jector VISION.RTM. and some
products by Antares. Such systems can be adapted for use with the
present invention's jet injection system.
[0034] In some embodiments, the injection device includes a
disposable nozzle and a reservoir having an additional substance.
The reservoir is located at the nozzle and the additional substance
is provided in a single use or single dose amount. The reservoir is
located within the body of the device and the nozzle features a
connector for fluid or other communication with the reservoir.
[0035] In some embodiments, rather than disposing a nozzle along
with an additional reservoir, an applicator for an additional
substance is provided that is attached to or separate from the
device. The nozzle can be disposed along with a gauge for adjusting
the amount of additional substance to be applied. The applicator
may be controlled through a button or other control component. In
some embodiments, the gauge can be configured as a ring that can be
rotated around the applicator button or other control device to
adjust the amount that the button is pressed and/or some function
of the other control device and/or to adjust the dose of applied
additional substance.
[0036] In some embodiments, the drug delivery pen can include an
adhesive material, such as a sticker, for assisting the user to
create a skin fold for administration of the drug and/or additional
substance.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] The invention is herein described, by way of example only,
with reference to the accompanying drawings. With specific
reference now to the drawings in detail, it is stressed that the
particulars shown are by way of example and for purposes of
illustrative discussion of the preferred embodiments of the present
invention only, and are presented in order to provide what is
believed to be the most useful and readily understood description
of the principles and conceptual aspects of the invention. In this
regard, no attempt is made to show structural details of the
invention in more detail than is necessary for a fundamental
understanding of the invention, the description taken with the
drawings making apparent to those skilled in the art how the
several forms of the invention may be embodied in practice.
[0038] FIGS. 1A-E illustrate an exemplary drug delivery pen
combined with a mechanism for topical application of an additional
substance to the drug injection site, according to some embodiments
of the present invention.
[0039] FIGS. 2A-C illustrates an exemplary drug delivery pen
combined with a mechanism for topical application of an additional
substance to the drug injection site, according to some embodiments
of the present invention.
[0040] FIGS. 3A-C illustrates an exemplary drug delivery pen
combined with a mechanism for topical application of an additional
substance to the drug injection site, according to some embodiments
of the present invention.
[0041] FIGS. 4A-D illustrates an exemplary drug delivery pen
combined with a mechanism for topical application of an additional
substance to the drug injection site, according to some embodiments
of the present invention.
[0042] FIGS. 5A-C illustrates an exemplary drug delivery pen
combined with a mechanism for application of a treatment element on
the drug injection site, according to some embodiments of the
present invention.
[0043] FIGS. 6A-C illustrates an exemplary drug delivery pen
combined with a mechanism for application of a treatment element on
the drug injection site, according to some embodiments of the
present invention.
[0044] FIGS. 7A-C illustrates an exemplary drug delivery pen and
cover combined with a mechanism for application of a treatment
element on the drug injection site, according to some embodiments
of the present invention.
[0045] FIGS. 8A-D illustrates an exemplary drug delivery pen
combined with a mechanism for application of a treatment element on
the drug injection site, according to some embodiments of the
present invention.
[0046] FIGS. 9A-C illustrates an exemplary drug delivery pen
combined with a mechanism for application of a treatment element on
the drug injection site, according to some embodiments of the
present invention.
[0047] FIGS. 10A-F illustrates an exemplary treatment element that
may be coupled to a drug injection at the drug injection site,
according to some embodiments of the present invention.
[0048] FIGS. 11A-E are block diagrams of exemplary drug delivery
devices, according to some embodiments of the present
invention.
[0049] FIGS. 12A-C illustrate an exemplary drug delivery pen
combined with a mechanism for application of a treatment element on
the drug injection site, according to some embodiments of the
present invention.
[0050] FIG. 13 is a flow chart illustrating an exemplary method for
controlling temperature of heating that is provided by a treatment
element in order to prevent degradation of a temperature sensitive
drug.
DETAILED DESCRIPTION OF THE INVENTION
[0051] The present invention relates to a drug delivery pen or
other drug injection devices for the injection of a drug at a drug
injection site, where the drug in injection device applies a
treatment that can improve injected drug's pharmacokinetic and/or
pharmacodynamic properties. The following description will refer to
a drug injection pen for illustrative, non-limiting purposes,
however, as can be understood by one skilled in the art, the
present invention is applicable to any other drug injection
devices.
[0052] FIGS. 1A-C are schematic diagrams of an exemplary drug
delivery pen 100 having a treatment element coupled to the delivery
pen, according to some embodiments of the present invention. FIGS.
1A and 1B depict an exemplary drug delivery pen 100 having a pen
shaft 110, an injection piston release trigger/button 112 (for
actuating a piston pump, for example, within the housing of the
delivery pen), a treatment release trigger/button 108 (for
actuating a pump for delivering the treatment), a needle opening
and a housing 102, treatment delivery openings 104, and a drug
dosage selector 106. FIG. 1A is a perspective view of the drug
delivery pen 100. FIG. 1B is a side view of the pen 100.
[0053] The drug delivery pen, for the delivery of insulin, may
function as do state of the art drug delivery pens by injecting the
selected and determined drug dosage 106 and using injection piston
release button 112 to release the piston (not shown) that presses
and/or otherwise places pressure on the drug reservoir syringe or
vial, for causing injection of the required dosage of drug (not
shown) into the targeted area and through needle housing 102. In
some embodiments, a fluid jet of the delivered drug can be utilized
instead of a syringe to delivery the drug through housing 102 to
the targeted delivery site. The drug delivery pen can provide an
additional treatment element, such as, an anesthetic, a drug for
inducing treatment, a drug for improving effectiveness of the
primary drug being injected. The primary drug can be insulin.
[0054] The treatment can be delivered over the target tissue using
the treatment delivery openings 104, wherein a fluid treatment
substance can be applied or sprayed onto the tissue. FIG. 1C is a
cross-sectional view of the drug delivery pen 100 showing the
treatment element 130 and components thereof. Treatment element 130
includes treatment compartment 120, a plurality of valves 122, a
pump 126 and a treatment release button 128. In some embodiments,
the treatment compartment 120 stores a formulation of a liquid,
ointment, solution, aerosol, foam, solid, gel foam, pressurized
liquid, gas, spray, pain reliever drug, analgesic, vasodilatation
drug, septic, alcohol, or the like for treatment of the skin tissue
area. In some embodiments, treatment may be applied prior to or
following deployment of the needle.
[0055] Treatment substance stored in compartment 120 can be pumped
to the treatment release openings 104 using schematic pump 126 that
is activated by pressing treatment release button 128. The
treatment release button 128 releases valves 122 to deliver
treatment liquid from the compartment 120 through the tube 124 that
leads to openings 104. The treatment applied to an area can lead to
improved pharmacokinetic and/or pharmacodynamic properties of the
primary drug being delivered by way of injection. The pathway by
which the pharmacodynamic and/or pharmacokinetic properties of the
drug are improved may be dependent on the treatment substance or
element utilized.
[0056] FIG. 1D is a partial exploded view of a drug delivery pen
140 having a manual injection portion 141, according to some
embodiments of the present invention. Pen 140 includes a pen body
150, a dosage release button 142, a treatment release button 148, a
drug dosage selector 146, and an injection coupling portion 144.
Injection coupling portion 144 is a connection mode to securely
affix injection portion 141 to the pen portion 140. The coupling of
the injection portion 141 to the pen portion 140 may be
accomplished by at least one or more connecting pieces, such as,
male/female connectors, threaded connectors, snap connector(s),
turn key connectors, hook connectors or any other suitable
connectors.
[0057] Manual injection portion 141 includes a treatment substance
reservoir 152, a treatment delivery opening 154 and a needle 158.
The manual injection portion 141 can be disposable after a single
use. However, the injection portion 141 can be reusable and can be
used a number of times or repeatedly over a period of time. Prior
to drug delivery the drug delivery pen body 150 is securely coupled
to manual injection portion 141 allowing a user to use the drug
delivery pen 140 by selecting a drug dosage using dosage selector
146. Treatment release button 148 triggers the release of the
treatment substance from the treatment reservoir 152 through
delivery openings 154. The timing of treatment release can be
performed prior to, during or following drug delivery, or in a
combination thereof. Drug delivery can be accomplished by setting
the dosage amount using dosage selector 146, manually inserting
needle 158 into the target site, releasing treatment substance
through delivery openings 154 and finally delivering the drug with
dosage release button 142.
[0058] FIG. 1E depicts an additional optional embodiment of the
manual drug delivery pen of FIG. 1D. Manual drug delivery pen
includes a drug delivery pen housing 160 and manual injection
portion 161. Pen housing 160 includes a pen body 170, a dosage
release button 162, a drug dosage selector 166, a treatment release
button 168, a treatment dosage selector 178, a treatment substance
tube 176, and an injection coupling portion 164. The injection
coupling portion 164 can be configured to securely affix injection
portion 161 to the pen body portion 160. Coupling of the injection
portion 161 to pen portion 160 can be accomplished by at least one
or more connecting pieces, such as, a male to female connector(s),
threaded connectors, snap connector(s), turn key connector(s), hook
connectors or any other connection devices.
[0059] Manual injection portion 161 is disposable for single use,
however, injection portion 161 may be used a number of times, or
repeatedly over a continuous period of time. Prior to drug delivery
the drug delivery pen body 170 is securely coupled to manual
injection portion 161 allowing a user to use drug delivery pen 160
by selecting a drug dosage using drug dosage selector 166.
Treatment dosage selector 178 determines the dosage of the
treatment substance to be released with treatment release button
168. Pressing treatment release button 168 triggers the release of
the treatment substance from the treatment reservoir (not shown)
through at least one or more treatment delivery tube 176 that ends
in treatment delivery openings 174. Timing of treatment dosage
selection and release may be performed prior to, during or
following drug delivery, or in a combination thereof. Drug delivery
is accomplished by setting the dosage amount using dosage selector
166, manually inserting needle 158 into the target site, releasing
treatment substance through delivery openings 174 as described
above and finally delivering the drug with dosage release button
162.
[0060] FIGS. 2A-C illustrate an exemplary drug delivery pen
according to the present invention which is similar to the
embodiments depicted in FIGS. 1A-C. In FIGS. 2A-C embodiments, the
treatment opening is on the opposite side of the needle housing.
FIGS. 2A and 2B depict a drug delivery pen 200 including a pen
shaft 210, an injection release button 208, a treatment release
button 212, a needle opening and a housing 202, a treatment
delivery opening 204 and a drug dosage selector 206. FIG. 2A is a
perspective view of the drug delivery pen 200. FIG. 2B is a side
view of pen 200.
[0061] The drug delivery, such as insulin delivery, functions in a
similar fashion as some conventional pens, such as NovoPen,
FlexPen, Sanofi Aventis pens or the like, by setting the determined
drug dosage 206 and pressing an upper button (not shown in FIGS.
2A-C) that pushes the syringe piston (not shown in FIGS. 2A-C) at
the required distance to inject the dosage that was set, such that
injection release button 208 is not required. For other pens, such
as the Autopen 24, after setting the determined drug dosage 206,
the drug is injected by releasing the injection release button 208
which releases the piston (not shown in FIGS. 2A-C) that pushes the
syringe piston to the required distance to inject the desired
dosage as set by dial 206. In some pens, for drug delivery, the
drug is accomplished by setting the determined drug dosage 206 and
pressing the needle release button 208, to release the needle (not
shown in FIGS. 2A-C) into the targeted area and through needle
housing 202, thereby injecting the required drug dosage through
that needle. However, the drug delivery pen according to the
present invention provides an additional treatment element, such
as, in the form of another drug, to induce a treatment for
improving the primary drug being injected. The above injection
pen's configuration and mechanism as well as other injection
devices, such as syringes or jet injectors, can be configured to be
used with devices and methods for applying additional treatment to
the vicinity of the drug injection site, as described by the
present and related applications. In some embodiments, the primary
drug can be insulin.
[0062] The treatment is delivered over the target tissue using the
pen's treatment delivery openings 204, wherein a fluid treatment
substance is applied onto the tissue. FIG. 2C is a cross-sectional
view of drug delivery pen 200 showing the treatment element 230 and
components thereof. Treatment element 230 includes a treatment
compartment 220, a plurality of valves 222, a pump 226, a treatment
tube 224 and a treatment release button 228. The treatment
compartment 220 stores a formulation, a fluid, such as a liquid,
ointment, solution, aerosol, pressurized liquid, gas, spray, pain
relieve drug, analgesic, vasodilatation drug, septic, alcohol, or
the like for treating the skin tissue area. The treatment may be
applied prior to or following deployment of the needle, in a two
step process one end of the pen for substance treatment delivery
using opening 204 and the opposite end for the injection using
housing 202.
[0063] A treatment substance stored in the compartment 220 can be
pumped to the treatment release openings 204 using schematic pump
226 that is activated by pressing the treatment release button 228.
The treatment release button 228 releases valves 222 to deliver
treatment liquid from the compartment 220 through the tube 224 that
leads to the openings 204. In some embodiments, the treatment
applied to an area may lead to improved pharmacokinetic and/or
pharmacodynamic properties of the primary drug being delivered by
way of an injection. The pathway by which the pharmacodynamic
and/or pharmacokinetic properties of the drug are improved may be
dependent on the treatment substance or element utilized.
[0064] FIGS. 3A-C illustrate an exemplary pen-type drug delivery
device similar to that described in connection with FIGS. 1A-E and
2A-C, however, in this case, the treatment substance is applied by
way of a roller-applicator ball 304 onto the tissue being treated.
FIGS. 3A and 3B illustrate similar views of drug delivery pen 300.
The drug delivery function of pen 300 is similar to the functions
of pens shown in FIGS. 1A-E and 2A-C. The drug dosage can be
controlled and determined using a dosage dial 306 that is delivered
via the needle housing 302 that encloses a needle (not shown in
FIGS. 3A-C), which is triggered using an injection release button
312. A treatment substance may be applied to the injected area
either prior to or following injection.
[0065] FIG. 3C depicts treatment element 330 including treatment
substance container 320 and substance application ball 304. The
treatment compartment 320 stores a fluid, such as, a liquid,
ointment, solution, aerosol, pressurized liquid, gas, spray, pain
relieve drug, analgesic, vasodilatation drug, septic, alcohol, or
the like for treating the skin tissue area. Treatment may be
applied with a ball 304 prior to or following deployment of the
needle, in at least a two-step process one end of the pen for
substance treatment delivery using ball 304 the opposite end for
the injection using housing 302.
[0066] FIGS. 4A-C illustrate another exemplary drug delivery pen
400, according to some embodiments of the present invention.
Treatment substance 430 used to improve the pharmacokinetic and/or
pharmacodynamic properties of the drug being delivered, such as
insulin, may come in the form of a solid, gel, gel form,
thixotropic solution or the like. The substance 430 may be applied
to a treatment area either prior to or following drug delivery
using a needle delivered through needle housing 402. The treatment
substance 430 can be a solid, stick, ointment, solution, pain
relieving drug, analgesic, vasodilatation drug, septic, alcohol, or
the like to treat the skin or tissue area. Substance treatment 430
can be rubbed, rolled over the treated area or applied in any other
suitable way.
[0067] The drug delivery pen 400 may be manufactured separately
from the individual treatment substance 430; alternative, the drug
delivery pen 400 may be manufactured along with treatment substance
430 being coupled thereto. FIG. 4D depicts the treatment substance
430 that can be configured to fit over the pen shaft 410 using a
sticker, a threading, an adhesive layer, a clip, or any other
coupling tools. The pen shaft 410 can be pushed through the lumen
of treatment substance 430. The treatment substance 430 can be
configured to fit circumferentially around the pen shaft 410. In
some embodiments, a single use or a reusable treatment substance
430 can be used with other drug injection devices, such as a
syringe.
[0068] FIG. 5A illustrates an exemplary drug delivery injectable
pen having a needle housing that can accept secondary devices for
substance treatment deployment or use, according to some
embodiments of the present invention. Drug delivery pen 500
includes shaft 510 that is configured to contain a volume of the
injectable drug (such as insulin) for delivery. A dosage dial 506
sets the dosage to be injected with a needle that is injected via
an injection release button 520 through the needle and the needle
housing 502.
[0069] In some embodiments, the drug delivery pen 500 includes a
glucose sensor 501 for measuring blood glucose with a finger stick.
Glucose sensor 501 can be configured to be on the top of the drug
delivery pen 500. The pen 500 can be used to release a needle that
is used to draw a drop of blood that may be placed over a finger
stick (not shown in FIGS. 5A-C) and is placed over the glucose
sensor 501 for reading the glucose levels in the drawn blood
sample. Additionally, the drop of blood can be applied to a finger
stick like glucose sensor inserted into a glucometer type slit, for
example on the top of pen 500 (not shown in FIGS. 5A-C).
[0070] FIG. 5B depicts a treatment element apparatus 530 that may
be coupled to the drug delivery pen 500, as shown in FIG. 5C, to
form drug delivery apparatus 540. The drug delivery apparatus 540
including the treatment element apparatus 530 and drug delivery pen
510 may be single unit.
[0071] The treatment element apparatus 530 includes a female
connector 524 that can be securely coupled to the needle housing
502, which has a corresponding male connector shape. The coupling
can be undertaken by threading, fitting, pin lock assembly,
adhesives or any other coupling methods. The drug delivery pen 530
includes treatment substance dispenser 520 that contains a roll 520
adhered to a plurality of treatment element 526. The treatment
element 526 can be securely placed over the end of needle housing
502. The treatment element 526 can be implemented in the form of a
pad (e.g., releasing an additional substance), a heating pad, a PCB
heating element, an optical treatment element, an electromagnetic
radiation treatment element, an electrical current treatment
element, an acoustical treatment element, a massaging treatment
element or an element related to any of the treatment methods
discussed above. The treatment element 526 can deliver treatment to
a target tissue prior to injection, following injection, or at the
time of injection to improve the pharmacodynamic and/or
pharmacokinetic properties of an injectable drug. Treatment element
526 can also include a power source to provide the desired
treatment power. Treatment element can include a control element,
such as an electrical circuit, to control the treatment profile.
Treatment element can be disposable, e.g., single use treatment
element, whereby after the treatment profile ends, the user can
dispose of the treatment element 526. Treatment element can be
reusable, whereby after the treatment profile ends, the user can
recharge it, exchange the power source, or exchange only a portion
of the treatment element 526 that is disposable and then reload it
into a new or the same treatment substance dispenser 520 or a
substance dispenser 630 shown in FIG. 6A or any other
configuration, as disclosed in the present application.
[0072] FIGS. 6A-C illustrate exemplary treatment element dispensers
that may be coupled to a drug delivery pen 500, as illustrated in
FIG. 5A. FIG. 6A illustrates a treatment dispenser 630 that is an
optional alternative to dispenser 530 of FIG. 5B. Treatment
dispenser 630 includes stackable treatment elements 626 that may be
coupled to the pen drug delivery device. FIG. 6B illustrates how a
drug delivery pen is coupled to the treatment element dispenser
630. Once the treatment element dispenser 630 is decoupled from the
delivery pen apparatus 650, the needle end of the apparatus is
coupled with a treatment element 626. The treatment element 626 is
alignable with the needle of drug delivery pen 650. This alignment
provides for a drug delivery and treatment apparatus 650 to induce
application of treatment using element 626 prior to, following, or
at the same time as undertaking drug delivery with the drug
delivery pen 600 in a one step process.
[0073] In some embodiments, the drug delivery using the pen 600 and
evoking treatment using element 626 may be undertaken in a two-step
process, where treatment element 626 is coupled to a non-needle end
of the drug delivery pen 600. This allows drug delivery and
treatment to be performed individually. For example, one can
trigger the drug delivery with the injection release button 612 and
later evoke treatment using element 626. The reverse is also true
where treatment may precede drug delivery.
[0074] In some embodiments, the treatment element, such as
treatment element 526 (shown in FIGS. 5A-C) or element 626, is
coupled to a single use needle that is secured to the pen before
each dose injection (as shown in FIGS. 1D and 1E), such that when
the needle is inserted into the body, the treatment element is
attached to and/or otherwise adheres to or around the injection
site, automatically, without the need of additional operations by
the user.
[0075] For any of the embodiments shown herein, the treatment
element may include an energy source, which can provide heat,
radiation, mechanical vibrations, suction, magnetic energy,
ultrasound, light irradiation, RF irradiation, microwave
irradiation, electrical stimulation, or any other form of energy or
combinations of those energy sources. For example, the treatment
element may include a heater to heat the injection site; or a
source of optical energy for the energy source, such as a light
source, including but not limited to LEDs or laser diodes for
example, with one or more other optical elements; or a micro-wave
generator or emitter configured to irradiate the injected region
with micro-wave radiation; or a radio frequency electromagnetic
radiation generator or emitter configured to irradiate the injected
region with radio frequency electromagnetic radiation; or a
vibration device configured to vibrate the injected region; or a
vacuum device for applying suction to the injected region; or an
electric field generator or emitter configured to apply an electric
field to the injected region; or a magnetic field generator or
emitter configured to apply magnetic field to the injected region;
or an acoustic signal generator or emitter configured to apply
acoustic stimulation to the injected region.
[0076] FIGS. 7A-C illustrates an exemplary drug delivery pen 700
similar to the pens shown in FIGS. 5A-C and 6A-C, that is coupled
to a treatment element dispenser 730 as shown in FIG. 7B to create
drug delivery and treatment apparatus 750. The apparatus 750
includes a treatment element dispenser 730 at the non needle end of
drug delivery pen 700. The apparatus 750 provides the drug delivery
pen with an ability to deliver drug(s) in a chosen dosage while
providing the treatment element that may improve the
pharmacokinetic and/or pharmacodynamic property of the delivered
drug. In some embodiments, the user can store his/her treatment
element(s) in a special case, or in the case of the drug injection
device. Before or after the drug injection, the user inserts the
treatment element, as discussed above, into the treatment element
dispenser 730 and applies it to the injection site. In some
embodiments, the treatment element can have a similar shape as the
treatment element dispenser 730 and can be coupled directly to the
drug delivery pen 700 without using the treatment element dispenser
as an adaptor.
[0077] FIGS. 8A-D illustrate an exemplary treatment apparatus,
similar to the one shown in FIGS. 1A-3C, according some embodiments
of the present invention. FIG. 8A depicts a drug delivery pen 800
used to deliver an injectable drug. FIGS. 8B and 8C are views of
the treatment element 830 that can be coupled to the drug delivery
pen 800, thus, forming a drug delivery and treatment apparatus, as
shown in FIG. 8A. The treatment element 830 can be coupled to the
pen 800 via the opening 840 that receives the needle end of the
drug delivery pen 800. Treatment element 830 includes a treatment
substance compartment 820 that can be utilized to store treatment
fluid. The treatment compartment 820 stores a fluid, such as gel,
foam, liquid, ointment, solution, aerosol, pressurized liquid, gas,
spray, pain relieve drug, analgesic, vasodilatation drug, septic,
alcohol, or the like for treating the skin tissue area. Treatment
can be applied prior to or following deployment of the needle.
[0078] Treatment liquid stored in the compartment 820 can be
delivered to the target tissue through the opening 804 using pump
826 that is activated by pressing the treatment release button 828.
The treatment release button 828 releases valves 822 to deliver
treatment liquid from the compartment 820 through the tube 824 that
leads to the opening 804. In some embodiments, the amount of
treatment liquid can be preset for a user. In some embodiments, a
special dial or other means, (not shown in FIGS. 8A-D, but
illustrated in FIG. 1E), may be used to set the amount of applied
treatment substance. The treatment applied to an area can lead to
improved pharmacokinetic and/or pharmacodynamic properties of the
primary drug being delivered by way of injection (e.g., insulin).
The pathway by which the pharmacodynamic and/or pharmacokinetic
properties of the drug are improved is optional and may be
dependent on the treatment substance or clement utilized.
[0079] FIGS. 9A-C illustrate the drug delivery pen 900 having the
treatment element provide pressure-related treatment, such as
suction, massage, or the like, according to some embodiments of the
present invention. FIG. 9A depicts a drug delivery pen and
treatment apparatus 950 including a drug delivery pen 900 and a
treatment element attachment 930 that can be mechanically coupled.
The apparatus 950 can be provided as an assembled or unitary drug
delivery device. The apparatus 950 can be coupled to the treatment
element 940 that is made from a pliable material that can withstand
pressure. Such material can be rubber, latex, or any other suitable
material configured to create suction over a given treatment area
similar to a plunger. The apparatus 950 is placed over the
treatment element 940 and is compressed to create further pressure,
as shown in FIGS. 9B and 9C, or suction when the pen is lifted.
Such suction will bring about vasodilatation in the treated tissue
and is configured to improve pharmacodynamics and/or
pharmacokinetics of the delivered drug. Drug delivery deployment
can be undertaken in the compressed form of the treatment element
940, as shown in FIG. 9C.
[0080] FIGS. 10A-D illustrate a variety of pressure based treatment
elements, according to some embodiments of the present invention.
FIG. 10A is a cross-sectional view of the treatment element shown
in FIG. 10B. The treatment element can be used during drug delivery
and includes a lumen 1000 allowing the needle to penetrate through.
FIG. 10C is a cross-sectional view of the treatment element shown
in FIG. 10D. The treatment element of FIG. 10D can be utilized
either prior to or following drug delivery in order to create
suction over the tissue area. The treatment elements of FIGS. 10A-D
can be used to create suction or vacuum in the vicinity of the drug
injection site and to induce local vasodilatation.
[0081] FIGS. 10E and 10F illustrate an exemplary treatment element
configured as a durable adhesive tape that is used to effectively
pinch a fold of skin while maintaining its shape. The treatment
element shown in FIG. 10E includes two sticky ends 1050 that are
bridged by a malleable section 1052. Each one of the ends 1050 is
placed over a patch of skin where an injection for example with a
syringe or a drug delivery pen is to be undertaken. Once in place,
the ends 1050 are pushed toward each other by the malleable section
1052 to form a bell type shape. Section 1052 can be manufactured
from a strong malleable material that can hold its shape, while
being repeatedly formed and deformed. FIG. 10F depicts the
treatment element of FIG. 10E in a folded form. Section 1052 can be
moulded and reshaped forming a treatment element for example to
bring about vasodilatation.
[0082] FIG. 11A is a block diagram of an exemplary drug delivery
apparatus 1100 having a treatment element 1102 incorporated into a
drug delivery pen 1104, wherein the treatment element is integrated
into the drug delivery pen, according to some embodiments of the
present invention. FIG. 11B is a block diagram of an exemplary drug
delivery apparatus 1110 having a treatment element 1112 and a drug
delivery device 1114 that are removably coupled to each other,
according to some embodiments of the present invention. The drug
delivery device 1114 or treatment element 1112 can function
independently of one another and can be securely coupled to each
other to form a single drug delivery and treatment apparatus 1110,
similar to the embodiment of FIGS. 4A-6C. Drug delivery device 1114
can be implemented as a syringe, drug delivery pen, drug delivery
jet injector or the like.
[0083] FIG. 11C is a block diagram of an exemplary drug delivery
and treatment apparatus that further includes a sensor 1126, such
as a glucose stick sensor, for measuring blood glucose. The drug
delivery apparatus 1120 communicates with an external processing
unit 1130. The processing unit can be a PDA, a cellular phone, a
computer, a laptop or any other device. The unit 1130 includes a
controller 1132 and a display 1134. The controller 1132 controls
analysis of data received from the drug delivery apparatus 1120 to
determine treatment or dosage form or the like related to the
functioning of drug delivery pen 1124, and treatment element 1122.
The processing unit 1130 provides the user with data regarding
historical and current use of the drug delivery apparatus 1120.
[0084] FIG. 11D is a block diagram of an exemplary drug delivery
device similar to the device shown in FIG. 11C, where the drug
delivery apparatus 1140 has an integrated sensor 1146, a processing
unit 1150 and a display 1148, according to some embodiments of the
present invention. This allows the user to fully control, visualize
all activity related to the drug delivery pen 1144 or the treatment
element 1142.
[0085] FIGS. 12A-C schematically illustrate exemplary treatment
element dispensers that may be coupled to a drug injection device
1200 (as shown in FIG. 12C), according to some embodiments of the
present invention. FIG. 12A illustrates a treatment element 1210
with a power source 1211. In some embodiments, the treatment
element 1210 includes a power source and a control element to
control a treatment profile. For instance, in case of heating,
treatment element 1210 can include a heater to heat the tissue
around the injection site to a temperature that improves drug's
pharmacokinetics and pharmacodynamics. In case of temperature
sensitive drugs, such as insulin, treatment element 1210 can
include a heater to heat the tissue around the injection site to a
temperature that improves drug's pharmacokinetics and
pharmacodynamics, without heating the drug above a limiting
temperature that may degrade it, such as 37.degree. C. in the case
of some types of insulin. Treatment element 1210 may include also
an adhesive layer on its bottom side covered with a laminate
1212.
[0086] In some embodiments the user has a case with one or few
treatment elements 1210. When the user wants to use treatment
element over drug injection site, the user takes adaptor 1220,
which can be stored in the same case or a different one, and
attaches one treatment clement 1210 to adaptor 1220, as shown in
FIG. 12B. Treatment element 1210 can be attached to adaptor 1220
with a weak mechanical locking, such as a plastic clip, or weak
adhesive or other ways known in the art. Then laminate 1212 can be
removed. Afterwards, adaptor 1220 is assembled or threaded over
drug delivery pen or syringe 1230, as shown at FIG. 12C. In some
embodiments needle cap 1231, can be removed from the needle. Then,
the needle is inserted into injection site tissue, the drug
injection device is operated and the drug is injected through
needle into the tissue. During that time, or slightly before or
after adaptor 1230, is pushed down to the tissue and treatment
element 1210 is attached to the tissue around drug injection
site.
[0087] In some embodiments, the attachment of treatment element
1210 to the tissue is configured to activate it automatically and
the treatment starts according to a predetermined treatment
profile. This function can be performed, for example, by a small
switch which is pressed when treatment element 1210 is attached to
the tissue. In some embodiments, the treatment element 1210 can be
activated manually. In some embodiments, treatment element can be
controlled and/or programmed for a specific treatment element
through a remote control or a connection to its case. Afterwards,
the injection device 1230 and the adaptor 1220 are lifted off,
either together or separately, and the treatment element 1210 is
left attached to the tissue and applies treatment to the vicinity
of the drug injection site. The user can remove treatment element
after treatment ends or later on. In some embodiments, the
treatment element includes an indicator for the user that indicates
the beginning of the treatment and the end of the treatment. In
some embodiments, the treatment element 1210 may be disposable.
[0088] In some embodiments, the treatment element's 1210 power
source 1211 may be rechargeable, so that after the treatment ends
and the user removes it from the skin, it can be put back to the
case and/or placed in a charging cradle for recharging which may be
disposed in said case. In some embodiments, the treatment element
1210 may have a disposable portion and a reusable portion. In some
embodiments, the drug injection device and at least one treatment
element are disposed in the same case prior to injection. This
provides additional comfort for the user and allows the user to use
both of them together or one after the other.
[0089] FIG. 13 is a flow chart depicting a method for controlling
the temperature of heating provided by a treatment elements that
heat the injection site tissue vicinity in order to prevent
degradation of a temperature sensitive drug. As shown in step 1300,
a drug is provided for injection to the patient, where the drug is
sensitive to degradation above a limiting temperature. In step
1301, a treatment element is provided that features a controllable
heating through a controllable heating element. In step 1302, the
treatment element is placed in thermal contact with the tissue to
be heated, such that heat from the treatment element is transferred
to the tissue to be heated.
[0090] In step 1303, a maximum temperature provided by the
treatment element is controlled, such that the temperature
experienced by the drug (that is, in the environment of the drug)
does not exceed the limiting temperature sustainable by the drug
before degradation occurs. In some embodiments, he maximum
temperature can be calibrated for each drug and/or class of drugs.
For example, for some types of insulin, the limiting temperature is
about 37.degree. C.
[0091] In some embodiments, such control can be provided through a
microprocessor or other processor for controlling the temperature
output by a heating element. A sensor can be provided in order to
measure the temperature at and/or near the tissue being heated, in
order to determine the temperature experienced by the drug.
[0092] The treatment element includes one or more materials capable
of generating an exothermic reaction, in which the amount of such
materials and/or ratio can be calculated in order for the
temperature of the reaction not to exceed the maximum temperature
set for the treatment element based on the desired limiting
temperature of the drug. The exothermic reaction can be a
heat-generating oxidation reaction, for example, with a mixture of
iron powder, activated carbon, salt and water. As can be understood
by one skilled in the art, other such mixtures of materials can be
used.
[0093] In some embodiments, the treatment element and the drug
delivery pen are not disposed in the same housing. However, in such
cases the user may forget to apply the treatment to the injection
site in some cases, thereby changing the pharmacokinetics, which is
undesirable. Therefore, to prevent that the drug delivery pen can
include a mechanism for reminding the user to apply the required
treatment, before, during or after injecting the drug into the
tissue. In some embodiments, the drug delivery pen includes a
mechanism that identifies whether the treatment was applied or not
and permits drug injection only when the tissue treatment was
applied. In some embodiments, the drug delivery pen includes, in
addition to the drug injection mechanism, a sensor that indicates
whether the treatment was applied or was not applied and a
processing unit that enables injection of the drug only when the
tissue treatment was applied. Such sensor can be an optical sensor
that measures optical properties of the local tissue, or Laser
Doppler Flowmeter ("LDF") that can measure local blood perfusion
and identify that the vasodilatation inducing local treatment was
applied and that the treatment level was adequate.
[0094] Example embodiments of the methods and components of the
present invention have been described herein. As noted elsewhere,
these example embodiments have been described for illustrative
purposes only, and are not limiting. Other embodiments are possible
and are covered by the invention. For example, at the present
application many of the suggested methods and devices can be used
for many of the drug injection devices, such as injection pens or
syringes or jet injector and other known in the art injection
devices, so although the examples are mainly given for injection
pens they are applied to the other injection devices as well. Such
embodiments will be apparent to persons skilled in the relevant
art(s) based on the teachings contained herein. Thus, the breadth
and scope of the present invention should not be limited by any of
the above-described exemplary embodiments, but should be defined
only in accordance with the following claims and their
equivalents.
[0095] Any and all references to patents, patent applications,
articles and other published and non-published documents made in
the present disclosure are herein incorporated by reference in
their entirety.
* * * * *