U.S. patent application number 15/462018 was filed with the patent office on 2017-07-06 for drug delivery system.
The applicant listed for this patent is C. R. Bard, Inc.. Invention is credited to William R. Bratt, Leonard J. Decant, John D. McDermott, David G. Spilka, Alexander W. Tessmer.
Application Number | 20170189213 15/462018 |
Document ID | / |
Family ID | 37637850 |
Filed Date | 2017-07-06 |
United States Patent
Application |
20170189213 |
Kind Code |
A1 |
McDermott; John D. ; et
al. |
July 6, 2017 |
Drug Delivery System
Abstract
Apparatuses and methods for coating and/or loading a medical
device with a therapeutic agent prior to or during the placement of
the medical device within the patient's body. In one variation, the
medical device is coated and/or loaded with a therapeutic agent
while the device is positioned in a delivery apparatus. In another
variation, the delivery apparatus comprises a reservoir for
retaining a therapeutic agent. The user may release the therapeutic
agent from the reservoir prior to or during the placement of the
device to coat and/or load the device with the therapeutic
agent.
Inventors: |
McDermott; John D.;
(Chandler, AZ) ; Tessmer; Alexander W.; (Phoenix,
AZ) ; Bratt; William R.; (Tempe, AZ) ; Spilka;
David G.; (Phoenix, AZ) ; Decant; Leonard J.;
(Scottsdale, AZ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
C. R. Bard, Inc. |
Murray Hill |
NJ |
US |
|
|
Family ID: |
37637850 |
Appl. No.: |
15/462018 |
Filed: |
March 17, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14309292 |
Jun 19, 2014 |
9597210 |
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15462018 |
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13524797 |
Jun 15, 2012 |
8758293 |
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14309292 |
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11994294 |
Dec 28, 2007 |
8206348 |
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PCT/US06/26786 |
Jul 7, 2006 |
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13524797 |
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60697649 |
Jul 8, 2005 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2/01 20130101; A61F
2/95 20130101; A61F 2/011 20200501; A61F 2250/0067 20130101; A61F
2240/001 20130101; A61F 2250/0068 20130101; A61F 2/86 20130101 |
International
Class: |
A61F 2/95 20060101
A61F002/95; A61F 2/01 20060101 A61F002/01; A61F 2/86 20060101
A61F002/86 |
Claims
1. A drug loading system, comprising: a medical device delivery
apparatus including a medical device disposed in a distal portion
thereof; an injection mechanism containing a therapeutic agent; and
an adaptor coupling the injection mechanism to a distal end of the
delivery apparatus and directing the therapeutic agent from the
injection mechanism into the distal portion of the delivery
apparatus to coat and/or load the medical device.
2. The drug loading system according to claim 1, wherein the
therapeutic agent comprises a material selected from a group
consisting of a stem cell, a gene therapy agent, a protein, a
nucleic acid chain, a growth factor, and combinations thereof
3. The drug loading system according to claim 1, wherein the
adaptor comprises a first lumen for directing the therapeutic agent
into the delivery apparatus, and a second lumen for directing an
excess portion of the therapeutic agent out of the lumen of the
delivery apparatus.
4. The drug loading system according to claim 1, wherein the
adaptor further comprises an interface for receiving a distal
portion of the delivery apparatus.
5. A method for implanting a medical device, comprising: disposing
a portion of the medical device in a delivery apparatus; and
releasing a therapeutic agent from a reservoir to coat and/or load
the medical device.
6. The method according to claim 5, further comprising the steps of
inserting the delivery apparatus into a patient's body, and
deploying the medical device into the patient's body.
7. The method according to claim 5, wherein the reservoir is
pressurized prior to the releasing step.
8. The method according to claim 5, wherein the reservoir is
positioned in the delivery apparatus.
9. The method according to claim 5, wherein the reservoir is
separate from the delivery apparatus, the method further comprising
the step of coupling the reservoir to the delivery apparatus before
releasing the therapeutic agent from the reservoir to load the
medical device.
10. The method according to claim 9, further comprising the steps
of providing the medical delivery apparatus to a medical
practitioner, and providing a container comprising the reservoir to
said medical practitioner.
11. A method for delivering a drug to a patient, comprising:
contacting a medical device with a therapeutic agent while the
medical device is disposed in a distal portion of a delivery
apparatus; inserting the delivery apparatus in a patient's body;
and deploying the medical device in the patient's body.
12. The method according to claim 11, wherein the contacting step
comprises injecting the therapeutic agent into a proximal end of
the delivery apparatus and allowing the therapeutic agent to travel
to the distal portion to coat the medical device prior to inserting
the delivery apparatus in the patient's body.
13. The method according to claim 12, wherein the contacting step
comprises injecting the therapeutic agent into the distal portion
of the delivery apparatus to coat the medical device prior to
inserting the delivery apparatus into the patient's body.
Description
PRIORITY
[0001] This application is a division of U.S. Patent Application
Ser. No. 14/309,292, filed Jun. 19, 2014, now U.S. Pat. No.
9,597,210, which is a division of U.S. Patent Application Ser. No.
13/524,797, filed Jun. 15, 2012, now U.S. Pat. No. 8,758,293, which
is a division of U.S. Patent Application No. 11/994,294, filed Dec.
28, 2007, now U.S. Pat. No. 8,206,348, which is a U.S. National
Stage Application under 35 U.S.C. .sctn.371 of International Patent
Application No. PCT/US2006/026786, filed Jul. 7, 2006, which claims
the benefit under 35 U.S.C. .sctn.119(e) to U.S. Provisional Patent
Application No. 60/697,649, filed Jul. 8, 2005, each of which is
incorporated by reference into this application as if fully set
forth herein.
BACKGROUND OF THE INVENTION
[0002] The introduction of drug-eluting stents (DES) has been a
major advancement in the field of cardiovascular medicine due to
the ability of the stents, which are coated with a drug, to prevent
restenosis of a vessel. Previous bare metal stents were only able
to reduce the rate of restenosis, caused by intimal hyperplasia, to
approximately 20-25%. The medicine or drug that is associated with
the DES is delivered directly to the blockage site, reducing
restenosis rates even further. However, implantable medical devices
that are pre-coated with drugs may have a significantly shorter
shelf-life than their non-coated counterparts. For example, the
potency of the drug may decrease over time, such that the
expiration date of the device must take into account the
degradation of drug. In addition, viability concerns may prevent
one from manufacturing a stent pre-coated with drugs and substances
that degenerate within a short period of time at room temperature.
For example, drugs, which are based on large molecule biologics
(e.g., DNA, protein, monoclonal antibodies, etc.) may be
particularly susceptible to degradation, and therefore are
difficult to implement as a pre-coated layer on a stent.
Furthermore, because most pre-coated devices do not permit the
medical practitioner to change or modify the drug associated with
the device, the pre-coated devices may limit the medical
practitioner's ability to determine and implement the best
medication/device combination based on specific treatment
needs.
[0003] Examples of current drug delivery devices and methods are
disclosed in U.S. Pat. No. 7,465,298, titled "METHODS AND SYSTEMS
FOR DELIVERING LIQUID SUBSTANCES TO TISSUES SURROUNDING BODY
LUMENS" issued to Seward et al., dated Dec. 16, 2008; U.S. Pat. No.
6,699,282 titled "METHOD AND APPARATUS FOR DELIVERY OF MEDICATION"
issued to Sceusa, dated Mar. 2, 2004; U.S. Pat. No. 6,656,162
titled "IMPLANTABLE DRUG DELIVERY STENTS" issued to Santini, Jr. et
al., dated Dec. 2, 2003; U.S. Pat. No. 6,613,084 titled "STENT
HAVING COVER WITH DRUG DELIVERY CAPABILITY" issued to Yang, dated
Sep. 2, 2003; U.S. Pat. No. 6,344,028 titled "REPLENISHABLE STENT
AND DELIVERY SYSTEM" issued to Barry, dated Feb. 5, 2002; U.S. Pat.
No. 5,954,693 titled "REPLENISHABLE STENT AND DELIVERY SYSTEM"
issued to Barry, dated Sep. 21, 1999; U.S. Pat. No. 5,857,998
titled "STENT AND THERAPEUTIC DELIVERY SYSTEM" issued to Barry,
dated Jan. 12, 1999; U.S. Pat. No. 5,755,722 titled "STENT
PLACEMENT DEVICE WITH MEDICATION DISPENSER AND METHOD" issued to
Barry et al., dated May 26, 1998; U.S. Pat. No. 5,685,847 titled
"STENT AND THERAPEUTIC SYSTEM" issued to Barry, dated Nov. 11,
1997; and U.S. Pat. No. 5,439,446 titled "STENT AND THERAPEUTIC
SYSTEM" issued to Barry, dated Aug. 8, 1995; each of which is
incorporated herein by reference in its entirety.
SUMMARY OF THE INVENTION
[0004] Disclosed herein are various apparatuses and methods for
loading and/or coating a medical device (e.g., stents, stent
grafts, endovascular grafts, vascular filters, etc.) with a
therapeutic agent (e.g., drugs, pharmaceuticals, antithrombogenic
agents, anti-inflammatory agents, antibacterial agents, anti-viral
agents, biologics, DNAs, RNAs, viral vectors, monoclonal
antibodies, growth factors, cells, stem cells, cartilage scaffolds,
etc.) immediately prior to or during the placement of the medical
device within a patient's body. In one variation, the delivery
apparatus is configured such that a medical device, loaded in the
delivery apparatus, can be coated or infused with a therapeutic
agent while the medical device is positioned in the delivery
apparatus. In another variation, the delivery apparatus is
configured such that a medical device housed in the delivery
apparatus is coated or infused with a therapeutic agent as the
medical device is being ejected out of the delivery apparatus and
into the patient's body. In yet another variation, the delivery
apparatus is configured to simultaneously deliver a medical device
and a therapeutic agent into a treatment area within the patient's
body.
[0005] For example, the delivery apparatus may include a reservoir
for holding a drug. The user can release the drug from the
reservoir to coat a medical device loaded in the delivery apparatus
prior to or during the insertion of the delivery apparatus into the
patient's body. In another example, a capsule containing a
therapeutic agent is positioned in the distal portion of the
delivery apparatus. The user can break the capsule and release the
therapeutic agent to infuse or cover the medical device secured in
the delivery apparatus whenever he or she is ready to do so. The
capsule may be pressurized to facilitate the distribution of the
therapeutic agent in the distal portion of the delivery
apparatus.
[0006] In another example, the delivery apparatus includes a
chamber at the distal portion of the apparatus for housing the
medical device. A suction mechanism is provided in the delivery
apparatus to draw a therapeutic agent, in the form of liquid or
gel, into the chamber to coat and/or load the medical device. In
one variation, the suction mechanism is positioned within the body
of the apparatus. A negative pressure is generated by the suction
mechanism, which results in the therapeutic agent positioned at the
distal opening of the delivery apparatus entering the apparatus due
to the surrounding atmospheric pressure. In one particular design,
the delivery apparatus includes a catheter and a slidable insert
forming a seal against the catheter lumen wall. As the insert is
displaced proximally relative to the catheter, suction is generated
in the lumen of the catheter, and the therapeutic agent positioned
at the distal opening of the catheter is drawn into the catheter
lumen. As the therapeutic agent fills the distal portion of the
catheter lumen, the medical device disposed therein is coated
and/or loaded with the therapeutic agent. In another variation, a
suction mechanism is coupled to the proximal end of the delivery
apparatus. A medical device is disposed in a distally positioned
chamber in the delivery apparatus. The distal chamber housing the
medical device is in fluid communication with the suction
mechanism. This fluid communication may be established through a
channel extending from the proximal end of the delivery apparatus
to the distal end of the delivery apparatus. The suction mechanism
generates a negative pressure in the channel to draw the
therapeutic agent positioned at the distal end of the delivery
apparatus into the distal chamber. As the therapeutic agent enters
the distal chamber, the medical device disposed therein is coated
and/or loaded with the therapeutic agent.
[0007] In another example, the delivery apparatus includes a drug
delivery lumen which provides a fluid conduit for infusing a
therapeutic agent into a chamber in the distal portion of the
apparatus. A medical device housed in the chamber can be coated
with a therapeutic agent at the user's discretion. A pressurized
foam or mist may be injected into the delivery lumen to coat the
medical device prior to or during the implantation process.
[0008] In another variation, the delivery apparatus includes a
reservoir at the distal end thereof, through which a medical device
can be delivered. The user may fill the reservoir with a
therapeutic agent, such that when the medical device is delivered
therethrough, the medical device is coated with the therapeutic
agent. In another design variation, the delivery apparatus includes
two lumens in fluid communication with a chamber, which houses a
medical device at the distal portion of the delivery apparatus. A
therapeutic agent can be injected into the first lumen and
extracted through the second lumen, such that a continuous flow of
therapeutic agent is delivered over the medical device to coat
and/or load the medical device with the therapeutic agent prior to
implantation.
[0009] In yet another variation, the medical device is coated or
infused with a therapeutic agent under pressure, while positioned
inside the body of the delivery apparatus, after which the medical
device is deployed into the patient's body. For example, an
aerospray-can carrying a therapeutic agent can be coupled to the
distal end of the delivery apparatus to inject therein the
therapeutic agent. The injected therapeutic agent is deposited onto
and/or absorbed into the medical device. In another example, the
medical practitioner couples a syringe filled with a therapeutic
agent onto the distal end of the delivery apparatus, and then
injects the therapeutic agent into the lumen of the delivery
apparatus by depressing the plunger on the syringe. The tip of the
syringe may be configured for insertion into the distal end of the
delivery apparatus. In another variation, a universal syringe
adaptor may be provided to couple syringe of various sizes to the
delivery apparatus. In yet another example, a pressurized drug
capsule is attached to the distal end of the delivery apparatus.
The user can release the drug from the capsule and infuse the drug
into the lumen of the delivery apparatus, which houses the medical
device.
[0010] Methods for loading, coating or infusing a medical device
with a therapeutic agent, while the medical device is disposed in
the delivery apparatus, are also disclosed herein. In one approach,
the therapeutic agent and the medical device are stored separately.
For example, a therapeutic agent comprising biologics, which
requires low temperature storage, is placed in a refrigerator,
while the delivery apparatus along with a medical device is stored
in a cabinet. The medical device may be pre-loaded into the
delivery apparatus and provided to the hospital or clinic as an
integrated unit. When the medical practitioner is ready to implant
the medical device, the therapeutic agent can be infused into the
delivery apparatus to coat and/or load the medical device. The
medical practitioner may also personally check and ensure that a
fresh and active therapeutic agent is loaded into the delivery
apparatus. Furthermore, the medical practitioner may be provided
with two or more therapeutic substances, from which he or she can
elect for loading onto the medical device. In another variation of
the method, the therapeutic agent is released onto the intended
treatment site as the medical device is being deployed by the
delivery apparatus.
[0011] These and other embodiments, features and advantages of the
present invention will become more apparent to those skilled in the
art when taken with reference to the following more detailed
description of the invention in conjunction with the accompanying
drawings that are first briefly described.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 illustrates one variation of a delivery apparatus
comprising a chamber for housing a medical device for delivery and
a reservoir for holding a therapeutic agent. In this particular
design, a capsule is utilized to contain the therapeutic agent.
[0013] FIG. 2 illustrates another variation of a delivery apparatus
including a capsule for containing a therapeutic agent.
[0014] FIG. 3 illustrates one variation of a capsule, which can be
removably inserted into a delivery apparatus.
[0015] FIG. 4 illustrates another variation of a delivery apparatus
including a built-in stopper to allow the user to extract a
liquid/gel carrying a therapeutic agent into a distal chamber,
which houses a medical device for deployment.
[0016] FIG. 5 illustrates another variation of a delivery apparatus
configured with a chamber for housing an implantable medical device
for deployment. The chamber is also configured for receiving a
therapeutic agent to coat/load the medical device.
[0017] FIG. 6 illustrates another variation of a delivery apparatus
with a valve positioned within the lumen of a catheter to form a
chamber at the distal portion of the catheter. In this variation,
the position of the valve can be displaced within the lumen of the
catheter.
[0018] FIG. 7 illustrates another variation of a delivery apparatus
including a reservoir at the distal end thereof, through which a
medical device can be delivered.
[0019] FIG. 8 illustrates another variation of a delivery apparatus
including a chamber in which a medical device can be coated/loaded
with a therapeutic agent prior to delivery into a patient's
body.
[0020] FIG. 9 illustrates another variation of a delivery apparatus
including a stopper and a valve to form a chamber for
coating/loading the medical device with a therapeutic agent prior
to deployment of the medical device.
[0021] FIG. 10 illustrates another variation of a delivery
apparatus with a reservoir located with a slidable element. The
reservoir can be utilized to hold a therapeutic agent. The slidable
element may also serve as a pusher for deploying an implantable
medical device placed in the distal lumen of the delivery
apparatus.
[0022] FIG. 11A illustrates another variation of a delivery
apparatus with built-in a displacement control mechanism to control
the pusher rod. A capsule is positioned within the distal end of
the pusher rod to serve as a reservoir for a therapeutic agent.
[0023] FIG. 11B illustrates an activation element for use with the
delivery apparatus of FIG. 11A. The activation element, when
inserted into the proximal end of the pusher rod, allows the user
to break the capsule and release the therapeutic agent.
[0024] FIG. 12 illustrates another variation of a delivery
apparatus including a valve positioned within a catheter to form a
chamber at the distal end of the catheter. In this variation, the
position of the valve is fixed within the lumen of the
catheter.
[0025] FIG. 13 illustrates another variation of a delivery
apparatus comprising a dual lumen catheter. A first lumen provides
a channel to allow the user to control the deployment of a medical
device positioned within a chamber at the distal end of the
apparatus. A second lumen provides a fluid conduit to allow the
user to infuse a therapeutic agent into the distal chamber.
[0026] FIG. 14 illustrates another variation of a delivery
apparatus with a dual lumen design. In this example, the apparatus
is configured with coaxial lumens and a pusher element slidably
positioned within the central lumen.
[0027] FIG. 15 illustrates another variation of a delivery
apparatus with a coaxial lumen design. An insert is slidably
positioned within the outer lumen to serve as a suction mechanism
to draw a therapeutic agent into the distal portion of the
apparatus.
[0028] FIG. 16 illustrates another variation of a delivery
apparatus where a pusher element for deploying the medical device
is configured with a lumen. The lumen may be utilized for infusing
the distal portion of the apparatus with a therapeutic agent.
[0029] FIG. 17 illustrates another variation of a delivery
apparatus comprising a delivery catheter with a tubing slidably
disposed therein. The tubing serves as a mechanism to deploy a
medical device. The lumen within the inner slidable tubing serves
as a fluid conduit for delivering therapeutic agent to coat/load
the medical device while the medical device is positioned within
the distal end of the apparatus.
[0030] FIG. 18 illustrates another variation of a delivery
apparatus comprising a slidable element positioned within the lumen
of a catheter for deploying the medical device. The slidable
element is configured with a suction mechanism which can be
utilized to draw fluids into the distal end of the apparatus.
[0031] FIG. 19A illustrates another variation of a delivery
apparatus including a pusher pad configured with flanges. The
radially extending flanges may assist with engagement of a stent
placed within the lumen of the delivery catheter.
[0032] FIG. 19B is a frontal view of the delivery apparatus of FIG.
19A, shown without the stent.
[0033] FIG. 20 illustrates another variation of a delivery
apparatus including a slidable insert configured to distribute a
therapeutic agent over a medical device placed within the lumen of
the delivery apparatus.
[0034] FIG. 21A illustrates another variation of a delivery
apparatus comprising a delivery catheter with a first lumen for
housing a medical device and a second lumen configured to
distribute a therapeutic agent over the medical device. As shown in
the example of FIG. 21A, the outer lumen is configured with inner
facing orifices to inject the therapeutic agent over the outer
circumferential surface of the medical device.
[0035] FIG. 21B is a cross-sectional view of the delivery apparatus
of FIG. 21A. The cross-section is taken at A-A as shown in FIG.
21A.
[0036] FIG. 22 illustrates another dual lumen delivery apparatus
configured for deploying a vascular filter. In this particular
design, the delivery apparatus is configured with a mechanism
(i.e., pusher element) for ejecting the medical device (i.e.,
vascular filter).
[0037] FIG. 23 illustrates yet another dual lumen delivery
apparatus design. In this example, a stent is placed over a
compressed balloon on a balloon catheter. An optional cap may be
provided to allow the user to temporarily seal the distal end of
the apparatus while the user coats or loads the stent with a
therapeutic agent infused through the elongated lumens of the
apparatus.
[0038] FIG. 24 illustrates another dual lumen delivery apparatus
configured with a pusher element. The pusher element is configured
with a lumen for fluid delivery.
[0039] FIG. 25 illustrates a method for coating and/or infusing an
implantable medical device under pressure, while the device is
loaded within a delivery apparatus.
[0040] FIG. 26 illustrates another variation of a delivery
apparatus comprising a reservoir of therapeutic agent that can be
attached to the distal end of the delivery catheter to coat/infuse
the medical device positioned within the delivery catheter. In this
particular example, the reservoir includes a pressurized capsule
loaded with a therapeutic agent. When the integrity of the capsule
is included, the therapeutic agent is released into the lumen of
the delivery catheter.
[0041] FIG. 27 illustrates yet another variation of a delivery
apparatus including a breakaway reservoir attached to the distal
end of a delivery catheter. Once the therapeutic agent within the
breakaway reservoir has been released into the lumen of the
delivery catheter, the user can detach the breakaway reservoir.
[0042] FIG. 28 illustrates another variation of a delivery
apparatus comprising a delivery catheter with orifices on the
circumferential surface, such that pressurized therapeutic agent
can be infused into the lumen of the delivery catheter through
these orifices. In the example shown in FIG. 28, an optional
adaptor is provided to assist the user in injecting a therapeutic
agent through circumferentially positioned orifices.
[0043] FIG. 29 illustrates another example for infusing the distal
portion of a delivery catheter with a therapeutic agent. In this
example, an adaptor is attached to the distal end of the delivery
catheter, such that a pressurized therapeutic agent is infused into
the delivery catheter through the circumferential orifices to coat
the medical device within the lumen of the delivery catheter. The
excess therapeutic agent is allowed to exit the distal end of the
delivery catheter through an outlet on the adaptor.
[0044] FIG. 30 illustrates yet another variation of a delivery
apparatus comprising a sponge-like reservoir within the distal
lumen of the apparatus. The sponge-like reservoir can be pre-loaded
with a therapeutic agent, such that when the medical device is
deployed through the distal end of the catheter, the sponge-like
reservoir will coat or wick the circumferential surface of the
device with the therapeutic agent. The example shown in FIG. 30 is
configured to deploy a stent with a balloon catheter.
[0045] FIG. 31 illustrates another example of utilizing a delivery
apparatus with a sponge-like reservoir. In this example, the
apparatus is configured with a pusher element for deploying a
stent.
[0046] The following detailed description should be read with
reference to the drawings, in which identical reference numbers
refer to like elements throughout the different figures. The
drawings, which are not necessarily to scale, depict selective
embodiments and are not intended to limit the scope of the
invention. The detailed description illustrates by way of example,
not by way of limitation, the principles of the invention. This
description would enable one skilled in the art to make and use the
invention, and describes several embodiments, adaptations,
variations, alternatives and uses of the invention, including what
is presently believed to be the best mode of carrying out the
invention.
[0047] Before describing preferred embodiments, it is to be
understood that unless otherwise indicated, this invention need not
be limited to applications in humans. As one skilled in the art
would appreciate, variations of the invention may be applied to
other mammals as well. Moreover, it should be understood that
embodiments of the present invention may be applied in combination
with various catheters, tubing introducers or other implantation
and connection devices for placement of a medical device into a
patient's body.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0048] Vascular filters, stents and endovascular stent-grafts are
used herein as examples of the types of medical devices to be
implanted with a delivery apparatus that possesses the integrated
capability to deliver a therapeutic agent onto the medical device,
in order to illustrate the various aspects of the invention
disclosed herein. In light of the disclosure herein, one skilled in
the art would appreciate that variations of the delivery apparatus
may be utilized for placement of different medical devices, not
specifically discussed herein, into a patients' body. Certain
variations of the delivery apparatus described in the preferred
embodiments of the present invention are particularly useful for
pre-loading a medical device with a therapeutic agent prior to
insertion of the medical device into the patient's body. Other
variations of the delivery apparatus according to the present
invention can be configured for simultaneous delivery of a
therapeutic agent during the deployment of the medical device. In
addition, some variations may support both pre-loading and
simultaneous delivery of therapeutic agents.
[0049] It must also be noted that, as used in this specification
and the appended claims, the singular forms "a," "an" and "the"
include plural referents unless the context clearly dictates
otherwise. Thus, for example, the term "a chamber" is intended to
mean a single chamber or a combination of chambers, "a fluid" is
intended to mean one or more fluids, or a mixture thereof.
Furthermore, the words "proximal" and "distal" refer to directions
closer to and away from, respectively, a medical practitioner
operating the apparatus, with the tip end (i.e., distal end) placed
inside the patient's body. Thus, for example, a catheter end placed
within the body of the patient would be the distal end of the
catheter, while the catheter end outside the patient's body would
be the proximal end of the catheter.
[0050] In one preferred embodiment, the delivery apparatus is
configured with a reservoir for containing a therapeutic agent. The
therapeutic agent can be released while the medical device is still
secure within the delivery apparatus and/or during the placement of
the medical device within the patient's body. In one variation, the
delivery apparatus includes a chamber for housing the medical
device, a reservoir for containing the therapeutic agent, and a
mechanism for deploying a medical device from the body of the
delivery apparatus. The delivery apparatus may further include the
medical device disposed in the chamber of the delivery
apparatus.
[0051] The drug or therapeutic agent can be one or more bio-active
agents. The bio-active agents can include, but are not limited to,
vasodilator, anti-coagulants, such as, for example, warfarin and
heparin. Other bio-active agents can include, but are not limited
to, agents such as, for example, anti-proliferative/antimitotic
agents including natural products such as vinca alkaloids (i.e.
vinblastine, vincristine, and vinorelbine), paclitaxel,
epidipodophyllotoxins (i.e. etoposide, teniposide), antibiotics
(dactinomycin (actinomycin D) daunorubicin, doxorubicin and
idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin
(mithramycin) and mitomycin, enzymes (L-asparaginase which
systemically metabolizes L-asparagine and deprives cells which do
not have the capacity to synthesize their own asparagine);
antiplatelet agents such as G(GP) II.sub.b/III.sub.a inhibitors and
vitronectin receptor antagonists; anti-proliferative/antimitotic
alkylating agents such as nitrogen mustards (mechlorethamine,
cyclophosphamide and analogs, melphalan, chlorambucil),
ethylenimines and methylmelamines (hexamethylmelamine and
thiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine
(BCNU) and analogs, streptozocin), trazenes-dacarbazinine (DTIC);
anti-proliferative/antimitotic antimetabolites such as folic acid
analogs (methotrexate), pyrimidine analogs (fluorouracil,
floxuridine, and cytarabine), purine analogs and related inhibitors
(mercaptopurine, thioguanine, pentostatin and
2-chlorodeoxyadenosine {cladribine}); platinum coordination
complexes (cisplatin, carboplatin), procarbazine, hydroxyurea,
mitotane, aminoglutethimide; hormones (i.e. estrogen);
anti-coagulants (heparin, synthetic heparin salts and other
inhibitors of thrombin); fibrinolytic agents (such as tissue
plasminogen activator, streptokinase and urokinase), aspirin,
dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory;
anti secretory (breveldin); anti-inflammatory: such as
adrenocortical steroids (cortisol, cortisone, fludrocortisone,
prednisone, prednisolone, 6.alpha.-methylprednisolone,
triamcinolone, betamethasone, and dexamethasone), non-steroidal
agents (salicylic acid derivatives i.e. aspirin; para-aminophenol
derivatives i.e. acetominophen; indole and indene acetic acids
(indomethacin, sulindac, and etodalac), heteroaryl acetic acids
(tolmetin, diclofenac, and ketorolac), arylpropionic acids
(ibuprofen and derivatives), anthranilic acids (mefenamic acid, and
meclofenamic acid), enolic acids (piroxicam, tenoxicam,
phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds
(auranofin, aurothioglucose, gold sodium thiomalate);
immunosuppressives: (cyclosporine, tacrolimus (FK-506), sirolimus
(rapamycin), azathioprine, mycophenolate mofetil); angiogenic
agents: vascular endothelial growth factor (VEGF), fibroblast
growth factor (FGF); angiotensin receptor blockers; nitric oxide
donors; anti-sense oligionucleotides and combinations thereof; cell
cycle inhibitors, mTOR inhibitors, and growth factor receptor
signal transduction kinase inhibitors; retenoids; cyclin/CDK
inhibitors; HMG co-enzyme reductase inhibitors (statins); and
protease inhibitors.
[0052] FIG. 1 illustrates the example where a delivery apparatus 2
includes a reservoir 4 containing a therapeutic agent. In this
particular design, the delivery apparatus 2 includes an elongated
catheter 6 and a capsule 8 positioned in the distal portion of the
catheter lumen 10. The capsule 8 serves as a reservoir for holding
a therapeutic agent. Optional ledges 12, 14 are provided on the
catheter lumen wall to prevent the capsule 8 from displacing in the
proximal direction. In one variation, the capsule 8 includes a
polymeric material. A pusher element 16 is slidably positioned
within the lumen of the catheter. The pusher element 16 includes a
flexible rod extending through a central lumen of the capsule 8 and
a pusher pad 20 attached to the distal end of the flexible rod 18.
The pusher pad 20 is configured with a plurality of channels 22,
such that fluids may flow from the proximal side of the pusher pad
towards the distal side of the pusher pad. Raised profiles 24 are
provided on the proximal side of the pusher pad for engaging the
capsule 8 and releasing the therapeutic agent from the capsule. In
one variation, the raised profiles 24 include a plurality of sharp
edges that can cut into the distal end of the capsule 8 to break
open the capsule and release the therapeutic agent contained
therein. A medical device 30, such as a vascular filter, ca be
positioned in the lumen at the distal end 32 of the catheter 6.
[0053] To release the therapeutic agent from the capsule 8, the
pusher element 16 is displaced in the proximal direction to break
the capsule 8. Once the capsule is broken, the therapeutic agent
flows out of the capsule and infuses the distal portion of the
catheter lumen. In one variation, the compartment within the
capsule is pressurized to facilitate the dispersion of the
therapeutic agent when the integrity of the capsule is compromised.
The therapeutic agent flows over the vessel filter and coats the
vessel filter with a layer of therapeutic agent. In one variation,
the therapeutic agent includes a gel, and in another variation, the
therapeutic agent includes a liquid.
[0054] As discussed herein, various other medical devices, such as
for example stents, grafts, stent-grafts, etc., can be placed in
the lumen of this catheter for delivery into a patient's body. In
one variation, the medical device includes an absorbing component
for retaining a portion of the therapeutic agent that flows over
the medical device. After the medical device has been implanted,
the absorbing component will release the therapeutic agent to the
implantation site over a period of time. For example, a porous
polymer layer may be incorporated on the medical device to retain
the therapeutic agent. Once the medical device 30 is loaded and/or
coated with the therapeutic agent, the user can advance the pusher
element 16 to eject the medical device out of the distal end 32 of
the catheter 6. In one approach, the user can release the capsule
and coat and/or load the medical device prior to inserting the
catheter into the patient's body. Once the catheter is inserted
into the patient's body, the pusher wire can be advanced distally
to deploy the medical device. In another approach, the catheter is
inserted into the patient's body first. Once the catheter is
positioned in the desired location, the capsule with the
therapeutic agent is released, followed by the deployment of the
medical device. In another variation, a locking mechanism is
provided at the proximal end of the delivery apparatus to lock the
deploying mechanism (e.g., pusher element) in position while the
apparatus is being transported, in order to prevent accidental
release of the therapeutic agent and/or accidental ejection of the
medical device.
[0055] Referring to FIG. 2, another example of a medical device
delivery apparatus 2 is illustrated. In this example, a balloon
catheter 34 is slidably positioned within the lumen of a delivery
catheter 36. A stent 38 is positioned over the compressed balloon
40 at the distal end of the balloon catheter 34. A capsule 42 is
positioned within the catheter lumen proximal of the balloon 40 on
the balloon catheter 34. An activation element 44 is coupled to the
shaft of the balloon catheter 34 for releasing the therapeutic
agent from the capsule 42. A separator 46 is positioned on the
shaft of the balloon catheter 36 proximal of the capsule 42. The
separator 46 keeps the released therapeutic agent in the proximal
portion of the catheter. In one variation, the separator includes a
stopper, coupled to the shaft of the balloon catheter, as shown in
FIG. 2. In another variation the separator includes a seal. In yet
another variation, the separator include a one-way valve, which
permits fluid flow in the distal direction but not the proximal
direction. The valve may allow the user to purge the air from the
lumen of the catheter by injecting a liquid into the proximal end
of the delivery catheter. Once the catheter lumen is filled with
the liquid, the user can release the therapeutic agent from the
capsule. The released therapeutic agent displaces the liquid at the
distal portion of the catheter lumen proximal of the valve. The
valve prevents or minimizes the therapeutic agent from dispersion
in the proximal direction. Although a separator 46 has been shown
and described, the apparatus 2 can be provided without such a
separator.
[0056] To release the therapeutic agent, the balloon catheter 34 is
displaced in the proximal direction, which causes the activation
element 44 to engage the capsule and release the therapeutic agent.
The released therapeutic agent flows distally to coat and/or load
the stent 38. In one variation, the stent includes a polymeric
covering that absorbs and/or binds the therapeutic agent. After the
stent has been implanted, the polymeric covering releases the
therapeutic agent over time at the implantation site.
[0057] In one variation, the reservoir containing the therapeutic
agent is an integral part of the delivery apparatus. In another
variation, the reservoir containing the therapeutic agent includes
an independent unit that can be removed or detached from the
delivery apparatus. FIG. 3 illustrates a detachable capsule 48 that
can be coupled onto the shaft of a pusher element or a balloon
catheter. The capsule 48 includes a lateral opening/slot 50 on the
circumferential surface of the capsule 48, such that the capsule
can be clipped onto a shaft through the lateral opening.
[0058] In another embodiment, the medical device apparatus includes
an elongated catheter and a deployment element slidably positioned
within the lumen of the catheter. A stopper is positioned on the
deployment element, such that axial displacement of the deployment
element creates a negative pressure, which enables suction of a
liquid or gel containing a therapeutic agent into the distal lumen
of the catheter.
[0059] FIG. 4 illustrates this embodiment, in which a balloon
catheter 52 positioned within the lumen of a delivery catheter 54
includes a stopper 56 coupled to the shaft of the balloon catheter
52. A medical device, e.g., a stent 58, is loaded on the balloon
catheter 52. As the stopper 56 is displaced distally and then
withdrawn in the proximal direction, suction is created within the
distal portion of the catheter lumen and a liquid or gel carrying a
therapeutic agent can be drawn into the distal portion of the
catheter lumen to coat and/or load the stent with the therapeutic
agent. The stopper 56 can be constructed to move independently of
the medical device. In another approach, the therapeutic agent can
be injected into the lumen of the catheter through the distal end
60 of the catheter 54. In this approach, a separator (e.g.,
stopper) keeps at least a substantial portion of the injected
therapeutic agent at the distal portion of the catheter lumen. In
another variation (not shown), a syringe with a needle is utilized
to infuse the distal portion of the lumen with a therapeutic agent.
The needle is inserted into the distal end of the catheter and
extends past the loaded medical device, such that a gel or liquid
therapeutic agent is injected proximal of the medical device. Once
the therapeutic agent fills the area between the medical device 30
and the separator 62, further injection of the needle/syringe
forces the therapeutic agent to migrate distally to coat the
medical device with the therapeutic agent. In yet another
variation, another lumen can be provided to delivery a suitable
bio-active material to an area proximate the medical device. In
this variation, the lumen is couple to a syringe on the proximate
end of the delivery mechanism.
[0060] FIG. 5 illustrates another example, in which an O-ring 64 is
placed around a pusher pad 66, such that the user can draw fluids
into the distal lumen of the catheter 68 by displacing the pusher
element 70 in a proximal direction of the delivery apparatus 2. In
this example, a medical device 72 (e.g., as a vascular filter,
etc.) is positioned in the distal lumen of the catheter for
deployment. In one variation, a suitable guide-wire or mechanism
can be used to prevent movement of the medical device 72 relative
to the catheter 68.
[0061] FIG. 6 illustrates another variation, in which a polymeric
disk 74 is positioned over the shaft of a pusher rod 76 to serve as
a separator. The polymeric disk 74 is configured with a plurality
of slits 78, such that it can act as a unidirectional valve to
permit fluids infused through proximal end of the catheter to
travel past the polymeric disk 74 and into the distal portion of
the catheter lumen 80, but essentially prevent its flow back
proximally. The separator along with the wall of the catheter forms
a chamber at the distal end of the catheter for housing a medical
device for deployment. Once the medical device is loaded in the
distal end of the catheter, a suitable therapeutic agent can be
infused/injected into the distal end of the catheter to coat and/or
load the catheter with the therapeutic agent. In one approach,
saline is first injected into the proximal end of the catheter to
displace the air within the lumen of the catheter. A therapeutic
agent is then injected through the distal opening to displace the
saline within the distal portion of the catheter lumen. In another
approach, a liquid therapeutic agent is injected directly into the
proximal end of the catheter to fill both the proximal portion and
the distal portion of the catheter lumen.
[0062] In another aspect, the delivery apparatus 2 includes a
reservoir 4 at the distal end thereof, through which a medical
device 30 can be delivered. FIG. 7 illustrates one example where
two valves 82, 84 are positioned within the lumen of a catheter 86
to form a chamber 88. The valves 82, 84 can be bi-directional
valves. In a variation, uni-directional valves can also be
implemented. The chamber 88 serves as a reservoir to hold a
therapeutic agent. In one variation, each of the valves 82, 84
includes a polymeric slit valve. In the particular example shown in
FIG. 7, each of the valves 82, 84 includes a polymeric disk
including a plurality of slits. The valves 82, 84 can be configured
segmented slits such that that the valves can deform in one
direction but not in the opposite direction. Prior to the delivery
of the medical device 30, a therapeutic agent is injected into the
chamber 88. In one variation, the therapeutic agent is carried in a
liquid substance. In another variation, the therapeutic agent is
carried in a gel-like substance. To deploy the medical device, the
user advances the pusher element 90 distally and forces the medical
device 30, through the valve 84, into the chamber 88 filled with
the therapeutic agent. The catheter 86 is then inserted into the
patient's body. Once the catheter 86 is in position, the medical
device 30 is pushed through the distal valve 82 and ejected out of
the catheter for deployment within the patient's body. In another
approach, the delivery apparatus is inserted into the patient's
body while the medical device is still positioned proximal of the
chamber 88. Once the catheter is positioned in place, the medical
device 30 is advanced distally through the chamber 88 and out the
distal end 92 of the delivery apparatus 2. As the medical device 30
passes through the chamber 88, the medical device 30 is coated with
the therapeutic agent.
[0063] In another variation, the delivery apparatus includes an
elongated body including a chamber at the distal portion of the
elongated body. The chamber is configured to hold a medical device
for delivery into a patient's body. While the device is inside the
chamber, the user can infuse the chamber with a therapeutic agent
to coat and/or to load the medical device with the therapeutic
agent. In one approach, the therapeutic agent is loaded into the
chamber while the catheter is still outside the patient's body. In
another approach, the therapeutic agent is loaded into the chamber
after the delivery apparatus has been inserted into a patient's
body.
[0064] FIG. 8 illustrates another example where a delivery
apparatus 2 includes an elongated catheter 94 with a chamber 96
positioned within the distal end of the elongated catheter 94. A
balloon catheter 98 carrying a medical device, such as for example
a stent 100, is slidably positioned in the lumen of the elongated
catheter 94. The stent 100 along with the balloon 102 on the
balloon catheter 98 is positioned in the distal chamber 96. The
chamber 96 is formed with a valve 104 and a separator 106 (e.g.,
seal, valve, etc.) positioned within the lumen of the catheter 96.
The medical device 100 can be placed in the catheter 94 with the
medical device positioned distal of the valve 106. In one
variation, the chamber 96 is loaded with a therapeutic agent by
inserting a needle on a syringe through the distal valve 104 and
injecting a therapeutic agent into the chamber 96. In another
variation, the shaft 108 of the balloon catheter includes two
lumens. A first lumen is utilized to inflate and deflate the
balloon 102, while a second lumen in conjunction with port 110 can
be utilized to inject a therapeutic agent into the distal chamber
96 within the catheter 94. The therapeutic agent is injected into
the second lumen at the proximal end of the balloon catheter. The
therapeutic agent then travels down the length of the balloon
catheter 98, and exits port 110, which is located close to the
balloon 102 at the proximal portion of the catheter shaft 98, and
into the chamber 96. Once the stent 100 is coated and/or loaded
with the therapeutic agent, the stent 100 can be deployed by
advancing the balloon 102 on the balloon catheter 98 out of the
catheter 94, and dilating balloon 102 to expand the stent 100.
[0065] In another example, the delivery apparatus 2 includes a
stopper 112 attached to the shaft of a balloon catheter 114 as
shown in FIG. 9. The stopper 112, along with a valve 116 positioned
within the distal end of the catheter, forms a chamber 118 when the
balloon catheter 114 is retracted within the lumen of the delivery
catheter 120. In one variation, the user can infuse the chamber
with a therapeutic agent to coat and/or load the medical device 30
(e.g., stent, vascular graft, etc.) positioned on the balloon
catheter 114 through the distal end of the catheter. The infusion
can be accomplished by a separate lumen and port 110, or by a
needle through the distal end, or by filing the catheter with
therapeutic agent prior to insertion of the device 30. In another
variation, the shaft of the balloon catheter includes a channel to
allow the user to infuse the chamber with a therapeutic agent by
injecting the therapeutic agent through the distal end of the
balloon catheter. In yet another variation, the delivery catheter
is configured with a second lumen, such that therapeutic agent can
be injected into the chamber through the proximal end of the
delivery catheter.
[0066] In another aspect, the delivery apparatus 2 includes a
medical device deploying mechanism 122. The medical device
deploying mechanism is integrated with a reservoir 4 for holding a
therapeutic agent for deployment into the lumen of the delivery
apparatus. The therapeutic agent can be released into a chamber
124, which holds a medical device, to coat and/or load the medical
device with the therapeutic agent. In one variation the deploying
mechanism 122 is slidably positioned within a lumen in the delivery
apparatus 2.
[0067] FIG. 10 illustrates one example, where the delivery
apparatus 2 includes an elongated catheter 126 and a pusher element
128 slidably disposed within the lumen of the elongated catheter
126. The distal portion of the pusher element 128 includes a
chamber 130 for containing a therapeutic agent. The distal end of
the chamber 130 includes an orifice 132 for releasing the
therapeutic agent into the lumen of the catheter 126. In one
variation, a valve 134 (e.g., a polymeric slit valve, etc.) is
positioned over the orifice 132. A displacement mechanism 136 is
placed within the chamber 130 to allow the user to control the
release of the therapeutic agent from the chamber 130. In the
particular example shown in FIG. 10, a balloon/diaphragm 138 is
positioned at the proximal end of the chamber 130. The shaft of the
pusher element 128 includes a lumen 140 in fluid communication with
the balloon/diaphragm 138, such that the user can inject a fluid
into the proximal end of the pusher element to inflate the balloon
and force the therapeutic agent out the orifice at the distal end
of the chamber. The valve 134 can be a check valve with a suitable
break pressure rating to prevent premature deployment of the
therapeutic agent outside of the reservoir.
[0068] In yet another variation, the valve 134 can be eliminated
with the expandable member 138 inflated to occupy a substantial
volume of the chamber. Deflation of member 138 can be used to
generate suction of fluid (gas or liquid or a combination thereof)
through orifice 132. Subsequent expansion of the member 138 can be
utilized to eject the suctioned fluid.
[0069] FIG. 11A illustrates another example, where a capsule 142 is
positioned within the chamber of the pusher element 144. A medical
device 30 (e.g., a vascular filter, stent, etc.) is disposed in the
lumen at the distal end of the catheter 146. A stop 148 is coupled
to the shaft 150 of the pusher element 144 to constrain the amount
of the pusher element's displacement in the axial direction. A
locking clip 152 is placed over the proximal shaft of the pusher
element to prevent accidental deployment of the medical device 30.
An activation mechanism is provided for releasing the therapeutic
agent contained in the capsule 142. In this particular design, the
activation mechanism includes an elongated wire 154 with a tapered
distal end 156, as shown in FIG. 11B. The elongated wire 154 can be
inserted into the proximal end 158 of the pusher element 144 and
down the lumen in the shaft 150. As the distal end 160 of the
elongated wire 154 passes through the chamber 162, the elongated
wire punctures the capsule 142 and releases the therapeutic agent
contained therein. In one variation, the compartment within the
capsule is pressurizes such that once the integrity of the capsule
has been compromised, the therapeutic agent is forced out of the
capsule due to the pressure. In such a configuration, a suitable
seal may be utilized to prevent flow of the therapeutic agent
towards the proximal end. The seal can be, an elastomeric seal
positioned between the wire 154 and the lumen 140, or by a suitable
tolerance fit between the lumen 140 and wire 154 without the use of
an elastomeric seal. The released therapeutic agent exits the
orifices 164 at the distal end of the chamber 162 coats and/or
loads the medical device 30 with the therapeutic agent. Once the
medical device 30 has been coated and/or loaded with the
therapeutic agent, the user can remove the locking clip 152 and
advance the pusher element 144 distally to eject the medical device
30 out of the delivery apparatus 2. Slots 147, may be provided on
the inner lumen of the delivery catheter 146 for holding the
medical device 30. For example, slots 147 may be configured to
interact with the medical device 30 to prevent the medical device
30 from rotating with the lumen of the delivery catheter 146. In
another variation, slots 147 are configured to guide the movement
of the medical device 30 as the medical device is being pushed out
of the lumen of the delivery catheter 146. In yet another
variation, slots 147 are provided to prevent appendages from the
medical deice 30 from interfering with the deployment of the
medical device.
[0070] In another aspect, the delivery apparatus includes a lumen
configured for delivering a therapeutic agent into a chamber that
houses a medical device for deployment inside a patient's body. A
pressurized liquid or gel carrying the therapeutic agent may be
transported through the drug delivery lumen down the shaft of the
delivery apparatus to coat and/or load the medical device housed in
the distal portion of the delivery apparatus.
[0071] In one example, as shown in FIG. 12, a separator 166 (e.g.,
valve, seal, etc.) is positioned within the lumen of a delivery
catheter 168 to form a chamber 170 at the distal portion of the
delivery catheter. Once the medical device 30 is loaded within the
chamber 170, a therapeutic agent can be injected into the chamber
170 to coat the medical device with a therapeutic agent. In one
variation, the separator 166 includes a unidirectional valve.
Saline is injected into the lumen of the catheter 168 through the
proximal side port 174 to purge air out of the lumen of the
catheter. As the saline travels down the shaft of the delivery
apparatus, the separator 166 is pushed open and the chamber 170 at
the distal portion of the delivery apparatus 2 is filled with
saline. Next, the user injects a therapeutic agent into the chamber
170 through the proximal end of the delivery apparatus to displace
the saline therein. The side port 174 is utilized to provide a
reservoir for the therapeutic agent. Continued filling of the
reservoir can cause the chamber 170 to be filled. As the
therapeutic agent fills the chamber 170 the medical device absorbs
and/or is coated and/or is loaded with the therapeutic agent. Once
the medical device has absorbed and/or is coated and/or is loaded
with the therapeutic agent, the apparatus can then be inserted into
a patient's body for the deployment of the medical device. In the
particular example shown in FIG. 12, a balloon catheter 176 is
utilized to deploy a stent 178. However, other suitable delivery
devices can also be utilized within the catheter 168 to deliver the
medical device.
[0072] In another approach, the therapeutic agent is injected into
the lumen of the delivery catheter through the port located at the
proximal portion of the delivery apparatus to fill the lumen and
coat and/or load the medical device with the therapeutic agent. In
one design variation, the apparatus is configured without a
separator 166. Therapeutic agent is injected through the distal
portion of the apparatus to completely fill the lumen and coat
and/or load the medical device with the therapeutic agent prior to
inserting the delivery apparatus within the patient's body. Once
the medical device is loaded with the therapeutic agent, the
delivery apparatus can be inserted into the patient's body to
deploy the medical device. Before the delivery apparatus is
inserted into the patient's body, the user may infuse the lumen of
the delivery apparatus with saline to flush out the excess
therapeutic agent within the lumen.
[0073] It is believed that the approach utilized for the
embodiments illustrated in, for example, FIG. 1-12, where the
therapeutic agent is infused prior to or during the implantation
alleviates problems associated with the shelf-life of such agents
being different from the shelf-life of the delivery apparatus or
the implantable medical device.
[0074] In another variation, the delivery apparatus includes a dual
lumen delivery catheter. The delivery catheter includes a first
lumen providing a conduit to allow the user to control the
deployment of a medical device secured within the distal end of the
delivery apparatus, and a second lumen providing a fluid conduit
for transporting a therapeutic agent from the proximal end of the
delivery apparatus to the distal end of the apparatus in order to
coat and/or load the medical device with the therapeutic agent.
[0075] FIG. 13 illustrates the example where the delivery apparatus
includes a coaxial dual lumen catheter 180 with a balloon catheter
182 slidably disposed within the central lumen 184. The balloon 186
on the balloon catheter 182 is shown in a deflated condition with a
stent 188 positioned over the deflated balloon. A therapeutic agent
can be injected down the outer lumen 190 to coat and/or load the
stent 188 or stent-graft with the therapeutic agent. In one
approach, the stent is coated with the therapeutic agent prior to
the insertion of the delivery apparatus into the patient's body. In
another approach, the stent 188 is coated with the therapeutic
agent while the delivery apparatus is inserted within the body of
the patient. In yet another approach, a therapeutic agent is
injected down the outer lumen 190 and then suctioned up the central
lumen 184 to induce a flow of the therapeutic agent over the
medical device positioned in the distal end of the delivery
apparatus to facilitate coating and/or loading of the medical
device with the therapeutic agent. FIG. 14 illustrates another
example, in which a medical device 192 is positioned within a
chamber at the distal end of the delivery apparatus, and a pusher
element 194 is positioned within the central lumen of the delivery
apparatus.
[0076] FIG. 15 illustrates another variation, in which an insert
196 is positioned within the outer lumen 198 of the dual lumen
delivery apparatus 200. The displacement of the insert 196 allows
the user to generate a suction to induce the therapeutic agent to
enter the distal chamber 202 and coat a medical device positioned
therein. The insert 196 may also be displaced proximally to create
a reservoir at the distal portion of the outer lumen for containing
a therapeutic agent. Later, the insert can be advanced distally to
eject the therapeutic agent into the chamber to coat the medical
device. In another example, as shown in FIG. 16, the pusher element
204 is configured with a lumen 206, such that the user can inject a
therapeutic agent down the shaft of the pusher element to infuse
the proximal section of the delivery catheter with a therapeutic
agent. In one application, the lumen 206 of the pusher element is
pre-filled with a therapeutic agent. When the user is ready to coat
the medical device 30 housed within the distal end of the delivery
catheter, the therapeutic agent is ejected out of the distal end of
the pusher element 204.
[0077] FIG. 17 shows another example where a first catheter 208 is
slidably disposed within the lumen of a second catheter 210. The
lumen of the first catheter 208 to can be utilized to infuse a
therapeutic agent to coat a medical device 30 positioned within the
lumen of the second catheter 210. To deploy the medical device 30,
the first catheter is advanced distally to eject the medical device
30. In one variation, the inner catheter 212 further includes a cap
214 positioned at the distal end of the catheter 212, as shown in
FIG. 18. An elongated wire 216 is slidably positioned within the
lumen of the inner catheter 212. A stopper 218 is connected to the
distal end of the elongated wire 216. The displacement of the
elongated wire 216 in the proximal direction moves the stopper 218
proximally and creates a chamber 220 within the lumen of the inner
catheter 212. In one application, the stopper can be displaced to
generate a suction. The suction draws a therapeutic agent into the
distal end of the outer catheter to coat the medical device 30
positioned therein. In another application, the stopper can be
displaced to create a reservoir that is pre-loaded with a
therapeutic agent. When the user is ready to coat the medical
device with the therapeutic agent, the stopper is then advance
distally to release the therapeutic agent into the lumen of the
outer catheter. Optionally, a valve is provided over the orifice of
the cap positioned at the distal end of the inner catheter.
[0078] In another aspect, the delivery apparatus includes a
delivery catheter 224 and a pusher element 226 slidably disposed
within the lumen of the delivery catheter, as shown in FIG. 19A.
The pusher element 226 includes an elongated wire 228 coupled to a
pusher pad 230. The pusher pad 230 includes flanges 232 that extend
radially into the corresponding grooves 234 on the inner lumen wall
of the delivery catheter 224, as shown in FIG. 19B. The flanges 232
ensure that the pusher pad engages the medical device, which is
housed within the distal end of the delivery apparatus 2, when the
pusher pad 230 is advanced distally to eject the medical device.
This configuration may be particularly useful for engaging a
medical device that has a large center opening (e.g., stent, etc.).
In one variation, the pusher pad 230 is further configured with
channels to allow fluids to flow through the pusher pad, such that
fluids infused through the proximal end of the catheter can reach
the distal end of the catheter. In another variation, the pusher
pad 230 includes a reservoir that contains a therapeutic agent. In
yet another variation, the pusher element 226 includes a flexible
rod connected to the pusher pad. The flexible rod includes a lumen,
such that a fluid injected into the proximal end of the flexible
rod flows out at the distal end of the pusher pad.
[0079] FIG. 20 illustrates another variation of a delivery
apparatus according to the present invention, comprising an
elongated insert 240 slidably disposed within the lumen of a
catheter 242. A distal end 241 of the elongated insert 240 is
inserted through a medical device 30 (e.g., stent), which is
positioned in the distal lumen of the catheter 242. The elongated
insert 240 includes a lumen 244 such that fluids can be transported
down the shaft of the elongated insert 240. An orifice 246 is
positioned at the distal portion of the elongated insert 240 such
that fluids injected into the lumen 244 of the elongated insert 240
can exit the elongated insert through the orifice 246. In one
variation, the elongated insert is provided with a plurality of
orifices 246, which are distributed on the circumferential surface
at the distal section of the elongated insert 240. The plurality of
orifices 246 may be configured such that fluids ejected out of
theses orifices can distributed over the length of the stent, which
is positioned around the distal section of the insert. In one
variation, the orifices 246 are distributed over the distal section
of the elongated insert in a spiral pattern. An optional flange or
disk 248 may be attached to the shaft of the elongated insert 240,
such that the advancement of the elongated insert 240 in the distal
direction causes the flange 248 to engage the medical device 30 and
force the medical device out of the distal end 250 of the delivery
catheter 242. In one variation, the flange 248 is configured with
through holes 252 (FIG. 20), such that fluid injected into the
proximal end of the delivery catheter lumen can travel past the
flange and enter the distal section of the catheter lumen. In
another variation, the elongated insert is configured such that it
can be rotated axially in relation to the catheter 242. The axial
rotation of the elongated insert can be used to facilitate the
distribution of the therapeutic agent over the medical device.
[0080] In the above application, a therapeutic agent is injected
into the proximal end of the elongated insert 240. The therapeutic
agent travels down the lumen 244 in the shaft of the elongated
insert 240 toward the distal end 241 of the elongated insert. The
therapeutic agent exits the orifices 246 on the distal section of
the elongated insert 240 and coats the stent 30 positioned around
the distal section of the elongated insert 240. Once the stent 30
is coated with the therapeutic agent, the elongated insert 240 can
be advanced distally to deploy the stent 30. In another variation,
the elongated insert is configured for coating the stent with a
therapeutic agent only. Once the stent is coated with the
therapeutic agent, the elongated insert is removed, and a pusher
element is inserted into delivery catheter to deploy the stent.
[0081] FIG. 21A illustrates another variation of a delivery
apparatus 2 comprising a dual lumen catheter 260. A medical device
30 (e.g., stent, etc.) is slidably positioned in inner lumen 262 of
the catheter 260 at the distal section of the catheter. The wall
between the inner 262 and the outer 264 lumen includes a plurality
of orifices 266 at the distal section thereof to enable fluid
communication between the inner lumen 262 and the outer 264 lumen,
as shown in FIG. 21B. A therapeutic agent can be injected into the
outer lumen at the proximal end of the catheter. The therapeutic
agent flows distally through the outer lumen 264 and through the
orifices 266 to enter into the inner lumen 262 and into contact
with the medical device 30. If the medical device 30 includes, an
absorption member, a porous member, or a sponge-like material, the
therapeutic agent can be absorbed into the body of the medical
device. Once the medical device is coated and/or loaded with the
therapeutic agent, it can then be deployed within the patient's
body.
[0082] It should be noted that the various embodiments described
herein can be utilized with a reservoir located in the catheter or
a reservoir external to the catheter.
[0083] FIG. 22 shows another variation where the delivery apparatus
2 further includes a pusher element 268 for deploying the medical
device 30 from the inner lumen 270 of the catheter 272. In this
particular example, a medical device (e.g., a vascular filter 294)
is loaded in the inner lumen 270 of the dual lumen catheter. In
this embodiment, the distal end of the catheter can be configured
with one or more slots 276 to separate the appendages 278, if any,
on the medical device 30, such as a vessel filter having a
plurality of legs, and prevent the appendages from entangling with
each other.
[0084] FIG. 23 illustrates another variation where the delivery
apparatus 2 includes a balloon catheter 280 carrying a stent 282
slidably disposed within a dual lumen catheter 284. A first port
286, located on the proximal section of the catheter, is configured
for accessing the inner lumen 288, while a second port 290, also
located on the proximal section of the catheter, is configured for
accessing the outer lumen 292 of the catheter. A therapeutic agent
can be injected into either the outer lumen 292 or the inner lumen
288 to coat and/or load the stent 282 positioned over the balloon
on the balloon catheter 280. In one approach, the therapeutic agent
is injected through one lumen while being extracted through a
section in the second lumen. As a result, a flow of therapeutic
agent is generated over the stent for coating the surface of the
stent with the therapeutic agent. Optionally, a cap 294 may be
provided to cover the distal end of the catheter 284 when the stent
282 is being coated within the inner lumen of the catheter 284. In
one variation, the cap includes a polymeric layer, which provides a
seal around the tip of the catheter, and which is configured for
placement over the tip of the catheter. In one example, two O-rings
296, 298 are placed within the inner lumen of the cap 294 to
provide the seal. Additionally, the cap 294 may also be utilized
with other embodiments described herein.
[0085] FIG. 24 illustrates yet another variation of a delivery
apparatus 2 comprising a pusher element 300 slidably disposed in
the inner lumen of a dual lumen catheter 302. In this variation,
the pusher element 300 includes a lumen 304 to provide fluid
communication through the length of the pusher element.
[0086] In another aspect of the invention, a medical device is
coated or infused with a therapeutic agent under pressure while
positioned in a delivery apparatus. The delivery apparatus may be
provided to the end user (e.g., surgeon performing the implant
procedure, etc.) with the medical device pre-loaded in the delivery
apparatus. In another variation, the end user has to load the
medical device in the delivery apparatus prior to implantation.
With the medical device loaded in the delivery apparatus, a
therapeutic agent, which is pressured in a container, is infused or
injected into the chamber of the delivery apparatus housing the
medical device. The therapeutic agent can be injected into the
delivery apparatus in various forms including, but not limited to,
mist, spray, foam, liquid stream, or gel stream. Various delivery
mechanisms (e.g., spray pump, aerosol can, pressure pump, etc.) can
be utilized to infuse the therapeutic agent into the delivery
apparatus to coat and/or load the medical device therein.
[0087] Referring to FIG. 25, an adaptor 310 is provided with
interfaces to couple a therapeutic agent injection mechanism 312
(e.g., a pressure generating source configured to eject the
therapeutic agent) to the distal end of a delivery apparatus. In
one variation, the delivery apparatus 2 includes a catheter 314
with a deployment mechanism 316 positioned within the lumen of the
catheter. A medical device 30 is positioned in a chamber within the
distal section of the catheter lumen. The adaptor 310 is connected
to the nozzle 318 of an aerosol can 320, which carries a
therapeutic agent. The distal end of the adaptor 310 has an
interface that receives the nozzle of the aerosol can, and the
proximal end of the adaptor has an interface 322 that receives the
distal end 324 of the catheter 314 and forms a seal around the
catheter tip. The user inserts the distal end 324 of the catheter
314 into the adaptor 310. The lever on the aerosol can is then
depressed to infuse the therapeutic agent into the lumen of the
catheter to coat and/or load the implantable medical device with
the therapeutic agent.
[0088] In another aspect of the invention, a reservoir containing a
therapeutic agent is configured for attachment onto the distal end
of the delivery apparatus (e.g., delivery catheter, etc.). Once the
reservoir is connected to the distal end of the catheter, the user
can release the therapeutic agent into the lumen of the delivery
apparatus to coat and/or load the medical device located in the
delivery apparatus. Referring to FIG. 26, a reservoir 4, including
a cap 330 containing a capsule 332 filled with a therapeutic agent
is inserted over the distal end of the delivery apparatus 2. The
user applies a pressure over the cap 330 to break the capsule 332
and release the therapeutic agent. The released therapeutic agent
flows into the lumen 334 of the catheter 336 and coats the medical
device 30 positioned therein. In one variation, the compartment
within the capsule is pressurized.
[0089] In another variation, the delivery apparatus is provided to
the user with a reservoir of a therapeutic agent connected to the
distal end of the catheter. A medical device is pre-loaded in the
delivery apparatus. When the user is ready to insert the medical
device into the patient, the user releases the therapeutic agent
from the reservoir to coat and/or load the medical device. In one
variation, the reservoir is pressurized to facilitate the ejection
of the therapeutic agent from the reservoir. Once the
coating/loading process is completed, the user then disconnects the
reservoir from the distal end of the delivery apparatus. With the
reservoir removed, the user can insert the delivery apparatus into
the patient and deploy the medical device.
[0090] A container can be attached to the distal end of a delivery
apparatus. A valve can be provided on the container to control the
outflow of a therapeutic agent retained within the reservoir. To
coat the medical device, the user releases the valve and allows the
therapeutic agent to flow into the lumen of the delivery apparatus.
Once the medical device is coated with the therapeutic agent, the
container is detached from the distal end of the delivery
apparatus. In another example, a delivery apparatus includes a
capsule 342 containing a therapeutic agent connected to the distal
end 344 of a delivery catheter 346, as shown in FIG. 27. A balloon
catheter 348 carrying a compressed stent 350 is slidably disposed
within the lumen of the delivery catheter 346. The compartment
within the capsule 342 is pressurized, such that once the valve or
barrier 352 sealing the capsules opening is compromised, the
therapeutic agent will be forced out of the capsule 342 due to the
pressure. To coat the stent 350 on the balloon catheter 348, the
user presses down on the neck 354 of the capsule to break the
barrier 352 sealing the proximal opening of the capsule. Once the
barrier 352 has been cracked, the therapeutic agent flows out of
the capsule 342 and into the lumen 356 of the delivery catheter
346. Once the stent 350 is coated with the therapeutic agent, the
user bends the capsule 342 relative to the delivery catheter 346,
and breaks the capsule 342 off the delivery catheter 346. With the
capsule removed, the distal end of the delivery catheter along with
the stent and the balloon catheter can be inserted into an
introducer sheath 346 and into a patient's body. Once the balloon
catheter is positioned in the desired location within the patient,
the delivery catheter is retracted to expose the stent. The balloon
on the balloon catheter is then inflated to deploy the stent.
[0091] In another variation, the delivery apparatus includes a
delivery catheter including a plurality of orifices positioned on
the circumferential surface at a distal section of the delivery
catheter. The user can infuse or introduce a therapeutic agent
through these orifices to coat and/or load a medical device located
in the lumen of the delivery catheter. For example, the delivery
catheter along with a medical device, which is secured within the
lumen of the catheter, may be dipped into a liquid therapeutic
agent or placed into a pressurized chamber filled with a
therapeutic agent. The therapeutic agent is diffused through the
orifices in the delivery catheter to coat and/or load the medical
device.
[0092] FIG. 28 illustrates one example, where a delivery catheter
360 including a plurality of circumferential orifices 362 is
inserted into the proximal end of an adaptor 364. A balloon
catheter 366 carrying a medical device is disposed within the lumen
of the delivery catheter 360. The medical device (e.g., stent 368)
is aligned within the distal portion of the catheter, such that the
orifices surround the medical device. A syringe 370 filled with a
therapeutic agent is attached to the distal end of the adaptor 364.
The user injects the therapeutic agent into the chamber 372 within
the adaptor. As the chamber 372 is filled with the therapeutic
agent, the therapeutic agent is forced into the lumen of the
catheter 360 through the distal opening 374 and the surrounding
orifices 362. Once the stent 368 is coated with the therapeutic
agent, the user can remove the syringe along with the adaptor.
[0093] FIG. 29 illustrates another variation of an adaptor 364
design. In this design, the adaptor includes an outer lumen and a
central lumen. The outer lumen 376 of the adaptor 364 directs
therapeutic agents into the lumen 378 of the catheter 360 through
the circumferential orifices 362 on the distal section of the
catheter. Excess therapeutic agent is allowed to flow out of the
distal opening of the catheter and into the central lumen 380 of
the adaptor 364. An opening 382 on the adaptor is provided to allow
the excess materials to exit the adaptor 364.
[0094] In another aspect, a sponge-like or porous material is
positioned close to the distal opening of a delivery apparatus. The
sponge-like material can serve as a reservoir to retain a
therapeutic agent. The therapeutic agent is pre-loaded or infused
into the sponge-like material prior to the deployment of the
medical device. As the medical device is propelled out of the
distal opening of the delivery apparatus, the medical device glides
over the sponge-like material, and the therapeutic agent is
provided onto the surface of the medical device. The delivery of
the therapeutic agent can be by wicking, or by squeezing of the
porous material to force the agent on to the medical device.
[0095] In one example, as shown in FIG. 30, the delivery apparatus
2 includes a delivery catheter 390 including a polymeric layer 392
with high absorbency attached to the inner wall of the catheter 390
at the distal portion of the catheter lumen. A balloon catheter 394
carrying a stent 396 is slidably disposed within the lumen 398 of
the delivery catheter 390. The user first infuses the polymeric
layer 392 with a therapeutic agent. The delivery catheter 390 along
with the stent 396 and the balloon catheter 394 are then inserted
into an introducer sheath positioned within the patient's body.
Once the balloon catheter 394 is positioned in the desired
location, the user can either advance the balloon catheter 394
relative to the delivery catheter 390, or retract the delivery
catheter 390 relative to the balloon catheter 394, to deploy the
stent. As the stent 396 passes over the polymeric layer 392, the
therapeutic agent is delivered onto the surface of the stent
396.
[0096] In another example, the delivery apparatus includes a
delivery catheter 390 with a sponge-like layer 400 positioned
around the distal lumen section. A stent 396 is slidably positioned
with the lumen of the catheter 390, as shown in FIG. 31. A pusher
element 402 is position with the lumen 398 proximal of the stent
396. The user first infuses the sponge-like layer 400 with a
therapeutic agent. Once the sponge-like layer 400 is infused with
the therapeutic agent, the user may advance the stent 396 distally
and position the stent within the sponge-like layer 400. Next, the
delivery catheter 390 is inserted into the patient's body, and the
stent 396 is deployed through the distal opening 404 of the
delivery catheter 390. In another variation, the sponge-like layer
in the delivery apparatus is pre-loaded with a therapeutic agent
before the delivery apparatus is provided to the user.
[0097] In another aspect, the medical device configured for
deployment with the deployment apparatus can include a coating to
facilitate the retention of the therapeutic agent on the medical
device. For example, a coating with affinity for binding a
therapeutic agent may be implemented on a medical device. In one
variation, a biocompatible polymer with affinity to one or more
therapeutic agents can be coated on the surface of the medical
device. In another example, a gelatin, a hydrogel, or other
hydrophilic or hydrophobic polymers may be integrated in the
medical device to absorb and/or retain the therapeutic agent. The
polymeric layer can be configured to allow slow release of the
therapeutic agent over time after the device has been deployed
within the patient's body. Polymers which may be suitable for
incorporating on a medical device as drug carrier include, but not
limited to, Poly(urethanes), Poly(siloxanes), Poly(methyl
methacrylate), Poly(vinyl alcohol), Poly(ethylene), Poly(vinyl
pyrrolidone), Poly(2-hydroxy ethyl methacrylate), Poly(N-vinyl
pyrrolidone), Poly(methyl methacrylate), Poly(vinyl alcohol),
Poly(acrylic acid), Polyacrylamide, Poly(ethylene-co-vinyl
acetate), Poly(ethylene glycol), Poly(methacrylic acid),
Polylactides (PLA), Polyglycolides (PGA),
Poly(lactide-co-glycolides) (PLGA), Polyanhydrides,
Polyorthoesters. Other absorptive materials or scaffold with
reservoir for retaining liquid that are well known to one skilled
in the art may also be utilized on the medical device for retaining
therapeutic agent.
[0098] In yet another aspect, methods for loading (e.g., infusing,
absorbing, coating, etc.) a medical device with a therapeutic agent
while the medical device is positioned in the lumen of the catheter
is disclosed herein. In one example, the method includes providing
a medical device, a therapeutic agent, and a delivery apparatus to
a medical practitioner. The medical device, the therapeutic agent,
and the delivery apparatus can be provided to the medical
practitioner in an integrated packaging or as separate items. In
one variation, the delivery apparatus and the medical device are
provided in a single sterile package, and the therapeutic agent is
provided in a separate container. The medical device can be
pre-loaded in the delivery apparatus before packaging.
Alternatively, the medical device can be provided as separated
items in the packaging. The medical device and delivery apparatus
integrated package can also be provided to the medical practitioner
as a single use deposable system. The integrated packaging may
minimize confusion in matching the appropriate delivery apparatus
with the medical device. Once the medical device is implanted, the
medical practitioner may dispose of the delivery apparatus. By
packaging the therapeutic agent separately, the medical
practitioner can selected the appropriate medication base on
specific patient need and the requirements of the specific implant
procedure. In some application, the therapeutic agent may need to
be refrigerated or store in an environmental control chamber.
Storing the therapeutic agent separately from the medical device
and the delivery apparatus may maximize storage efficiency.
[0099] In another variation, the therapeutic agent is packaged with
the delivery apparatus, and the medical device is provided as a
separate unit. This approach may allow the manufacturer to match up
a therapeutic agent with the appropriate delivery apparatus. The
medical practitioner can then select the appropriate medical device
for deployment with the delivery apparatus. For example, the
medical practitioner may select the medical device from a group of
devices based on type, functional capability, size, material
property, etc. In yet another variation, the therapeutic agent is
provided in the same packaging as the medical device, and the
delivery apparatus is provided separately. In some application, a
particular therapeutic agent may be especially suitable for use
with a specific medical device. Thus, it would be convenient for
the manufacture to package the therapeutic agent with medical
device. Furthermore, it may also be useful to package an interface
(e.g., a universal syringe adaptor, aerosol can adaptor, etc.)
and/or a therapeutic agent loading mechanism (e.g., a syringe,
etc.) with the delivery apparatus. In certain application, the
manufacture can also provide a medical device loading instrument
along with the delivery device to assist the medical practitioner
to insert the medical device into the delivery apparatus.
[0100] As discussed above, the medical device can be provided to
the medical practitioner preloaded in the delivery apparatus or it
can be provided to the medical practitioner as a two separate
items, requiring the medical practitioner or his assistant to load
the medical device into the delivery apparatus prior to deployment.
The therapeutic agent may be provided to the medical practitioner
as an integrated package having the therapeutic agent along with
the delivery apparatus and/or the medical device. The therapeutic
agent, the medical device, and the delivery apparatus, may also be
provided to the medical practitioner as individual units.
[0101] With the device loaded in the delivery apparatus, the
therapeutic agent is infused into the delivery apparatus to load
the medical device with the therapeutic agent. For example, a
syringe may be utilized to inject the therapeutic agent into the
delivery apparatus either from the proximal end or the distal end
of the delivery apparatus, depending on the design of the specific
delivery apparatus. A syringe adaptor may be provided for coupling
the syringe with the delivery apparatus. In one variation, the
therapeutic agent is preloaded into a syringe. The user can remove
a cap on the syringe and insert the tip of the syringe into the
distal opening of the delivery apparatus. The therapeutic agent is
then injected into the lumen of the delivery apparatus to load the
medical device with the therapeutic agent. In another variation,
the therapeutic agent is provided within a container. A syringe
with the needle can be used to extract the therapeutic agent out of
its container and into the syringe. The needle on the syringe can
then be inserted into the distal end of the delivery apparatus to
inject the therapeutic agent. Alternatively, the needle can be
removed, and the tip of the syringe inserted into the distal end of
the delivery apparatus to infuse the therapeutic agent. In another
variation, an adapter is provided to couple the syringe to the
distal tip of the delivery apparatus to assist with the injection
of the therapeutic agent into the delivery apparatus. As one
skilled in the art having the benefit of this disclosure would
appreciate, the syringe could also be utilized to inject
therapeutic agent into the proximal end of the delivery
apparatus.
[0102] In another example, an aerosol can carrying the therapeutic
agent is couple to the delivery apparatus (either directly or
through an adaptor) to infuse the inner chamber of the delivery
apparatus, which holds the medical device. In one variation, the
therapeutic agent is loaded onto the medical device, which is
positioned in the delivery apparatus, before the delivery apparatus
is inserted into the patient's body. In another variation, the
therapeutic agent is loaded onto the medical device after the
delivery apparatus, along with the medical device, has already been
inserted into the patient's body.
[0103] In yet another example, the therapeutic agent is provided to
the medical practitioner in a pump dispenser (e.g., spray pump,
microsprayer, lotion pump, trigger sprayer pump, pressure sprayer,
mist sprayer, etc.). With the medical device positioned in the
deployment apparatus, the medical practitioner dispenses the
therapeutic agent out of the pump dispenser and into the delivery
apparatus to load the medical device with the therapeutic agent. An
adaptor can be used to facilitate the transfer of the therapeutic
agent from the pump dispenser into the delivery apparatus. In
addition, the method for loading the medical device positioned in
the delivery apparatus can also include the step of pressurizing
the pump dispenser or other container containing the therapeutic
agent, prior to injecting or spraying the therapeutic agent into
the delivery apparatus to load the medical device with the
therapeutic agent. The pressurizing step may include activating a
pump to increase the pressure inside of a canister containing the
therapeutic agent. In another variation, the pressurizing step
comprises shaking a canister (e.g., an aerosol canister, etc.)
containing the therapeutic agent to increase the pressure in the
canister.
[0104] One skilled in the art having the benefit of this disclosure
would appreciate that some variations of the delivery apparatus
disclosed herein may be applicable for simultaneous delivery of a
therapeutic agent and a medical device into a pre-selected site
within a patient's body. The medical device chamber of the delivery
apparatus may be pre-loaded with a therapeutic agent, such that the
therapeutic agent and the medical device can be introduced into the
pre-selected site within the patient's body simultaneously. It
should also be appreciated that during the deployment of the
medical device, a therapeutic agent may also be injected through a
drug lumen in the delivery apparatus to infuse the deployment site
with a therapeutic agent.
[0105] As discussed above, the medical device disclosed herein may
be configured to serve as a carrier to deliver a therapeutic agent
onto a target site within a patient's body. For example, a method
utilizing a medical device as a gene therapy delivery platform is
described below. The delivery apparatus is configured to deliver
the medical device, which carries stem cells or a gene therapy
agent, to a pre-selected location within the patient's body. In one
variation, the medical device includes a stent covered with a
polymeric layer configured to absorb proteins, nucleic acid chains
and/or other large molecules is loaded in the delivery apparatus.
In one variation, while the stent is loaded in the delivery
apparatus, Vascular Endothelial Growth Factor-2 (VEGF-2) in the
form of naked DNA plasmid, a nonviral vector, is loaded into the
polymeric layer on the stent. With the VEGF-2 loaded on the stent,
the delivery apparatus is inserted into the patient's body to
deploy the stent at the pre-selected site. In another approach, the
gene therapy agent is loaded in a reservoir in the distal portion
of the delivery apparatus. Immediately prior to or during the
deployment of the stent, the gene therapy agent is then released
into the lumen of the delivery apparatus.
[0106] One skilled in the art having the benefit of this disclosure
would also appreciate that the delivery apparatus disclosed herein
is not limited for loading and/or coating a medical device with a
therapeutic agent for deployment inside a patient's body. Various
other chemicals, biochemical, and biologics may also be coated
and/or loaded onto a medical device for delivery into a patient's
body.
[0107] While the invention has been described in terms of
particular variations and illustrative figures, those skilled in
the art will recognize that the invention is not limited to the
variations or figures described. In addition, where methods and
steps described above indicate certain events occurring in certain
order, those skilled in the art will recognize that the ordering of
certain steps may be modified and that such modifications are in
accordance with the variations of the invention. Additionally,
certain of the steps may be performed concurrently in a parallel
process when possible, as well as performed sequentially as
described above. Therefore, to the extent there are variations of
the invention, which are within the spirit of the disclosure or
equivalent to the inventions found in the claims, it is the intent
that this patent will cover those variations as well. Finally, all
publications and patent applications cited in this specification
are herein incorporated by reference in their entirety as if each
individual publication or patent application were specifically and
individually put forth herein.
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