U.S. patent application number 11/408121 was filed with the patent office on 2006-11-16 for delivery system and devices for the rapid insertion of self-expanding devices.
Invention is credited to Charles Agnew, Jacob A. Flagle, David C. Lentz, Jeffry S. Melsheimer, Thomas A. Osborne, Dharmendra Pal, Fred T. Parker.
Application Number | 20060259118 11/408121 |
Document ID | / |
Family ID | 37115940 |
Filed Date | 2006-11-16 |
United States Patent
Application |
20060259118 |
Kind Code |
A1 |
Pal; Dharmendra ; et
al. |
November 16, 2006 |
Delivery system and devices for the rapid insertion of
self-expanding devices
Abstract
Delivery systems for self-expanding devices are provided having
a system proximal portion with a handle, an elongate middle section
delivery device with an outer sheath and inner compression member,
and a system distal portion including an outer guide channel member
with first and second end portions defining a guide channel that
slidably receives an inner guide channel member having a guide
channel, the guide channels being substantially aligned. A mounting
region for self-expanding devices is disposed radially between the
inner and outer guide channel members. The outer guide channel
member has a stepped profile from a first outer diameter to a
second smaller outer diameter located near a transition region
having a breech position opening for passage of a wire guide,
catheter, or other medical instrument. The outer member is axially
slideable relative to the inner member to deploy a self-expanding
device. Methods of using and manufacturing are also provided.
Inventors: |
Pal; Dharmendra;
(Wilmington, MA) ; Agnew; Charles; (West
Lafayette, IN) ; Flagle; Jacob A.; (Indianapolis,
IN) ; Lentz; David C.; (Bloomington, IN) ;
Melsheimer; Jeffry S.; (Springville, IN) ; Osborne;
Thomas A.; (Bloomington, IN) ; Parker; Fred T.;
(Unionville, IN) |
Correspondence
Address: |
BRINKS HOFER GILSON & LIONE/CHICAGO/COOK
PO BOX 10395
CHICAGO
IL
60610
US
|
Family ID: |
37115940 |
Appl. No.: |
11/408121 |
Filed: |
April 20, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60673199 |
Apr 20, 2005 |
|
|
|
Current U.S.
Class: |
623/1.11 |
Current CPC
Class: |
A61F 2/9517 20200501;
A61M 25/0045 20130101; A61F 2/95 20130101; A61M 25/005 20130101;
A61M 25/0662 20130101; A61M 25/0053 20130101 |
Class at
Publication: |
623/001.11 |
International
Class: |
A61F 2/06 20060101
A61F002/06 |
Claims
1. A delivery apparatus for the rapid insertion of medical devices,
comprising: a tubular inner guide channel member comprising a
distal first end portion having an entry port and a proximal second
end portion having an exit port and defining a guide channel
therebetween that is sized to slidably receive a wire guide, a
proximal stent restraint is disposed about and operatively coupled
to the inner guide channel member intermediate the inner guide
channel member first and second end portions, and a stent platform
is disposed about the inner guide channel member distal the
proximal stent restraint and proximal the inner guide channel
member entry port; and an outer guide channel member comprising a
distal first end portion having a distal opening and proximal
second end portion having an exit port and defining a guide channel
therebetween, the inner guide channel member second end portion,
the proximal stent restraint, and the inner guide channel member
stent platform being positioned within the guide channel of the
outer guide channel member intermediate the outer guide channel
member distal opening and exit port, and the outer guide channel
member being axially slideable relative to the inner guide channel
member, wherein the guide channel of the inner guide channel member
and the guide channel of the outer guide channel member are
substantially coaxially aligned, wherein the outer guide channel
member exit port is in fluid communication with the inner guide
channel member exit port.
2. The device of claim 1 further comprising an atraumatic tip
comprising a distal first end portion having an entry port and a
proximal second end portion having an exit port and defining a
guide channel therebetween, the atraumatic tip second end portion
being operatively coupled to the inner guide channel member first
end portion.
3. The device of claim 2 wherein the atraumatic tip guide channel
is in fluid communication with the guide channel of the inner guide
channel member
4. The device of claim 2 wherein the atraumatic tip second end
portion forms a distal stent restraint of the inner guide channel
member stent platform,
5. The device of claim 4 wherein the atraumatic tip first end
extends distally relative to the outer guide channel member distal
end.
6. The device of claim 5 wherein the outer guide channel member
distal opening is spaced from the atraumatic tip sufficient to
allow flushing.
7. The device of claim 1 wherein the outer guide channel member
exit port comprises a substantially breech position opening.
8. The device of claim 7 wherein the outer guide channel member
exit port is spaced proximally of the inner guide channel member
second end portion.
9. The device of claim 7 wherein the outer guide channel member
exit port is substantially aligned with a longitudinal axis of the
inner guide channel member.
10. A delivery apparatus for the rapid insertion of medical
devices, comprising: an inner guide channel member comprising a
distal first end portion having an entry port and a proximal second
end portion having an exit port and defining a guide channel
therebetween, and a stent platform disposed about the inner guide
channel member intermediate the entry port and the exit port; an
outer guide channel member comprising a distal first end portion
having a distal opening and proximal second end portion having an
exit port and defining a guide channel therebetween and sized to
slidably receive the inner guide channel member second end portion
and stent platform, the outer guide channel member comprising a
stent constraining inner surface intermediate the outer guide
channel member distal opening and exit port, the stent constraining
inner surface being located at or near the inner guide channel
member stent platform and being circumferentially spaced radially
from the inner guide channel member stent platform, and the outer
guide channel member comprising a stepped profile having a first
outer diameter intermediate the outer guide channel member first
and second end portions and a second smaller outer diameter
proximal to the outer guide channel member exit port, wherein outer
guide channel member is substantially coaxially slideable relative
to the inner guide channel member second end portion, and wherein
the outer guide channel member exit port is in fluid communication
with the inner guide channel member exit port.
11. The device of claim 10 wherein the outer guide channel member
exit port comprises a diameter substantially equal to the
difference between the outer guide channel member first outer
diameter and second smaller outer diameter.
12. The device of claim 10 wherein the outer guide channel member
further comprises a flushing port at or near the first end
portion.
13. The device of claim 10 wherein the outer guide channel member
comprises an inner layer, a coil forming a plurality of turns
positioned longitudinally around the inner layer with spacings
between the turns, and an outer layer comprising melt bonding
material positioned longitudinally around the coil and melt bonded
to the inner layer through the coil spacings.
14. A delivery apparatus for the rapid insertion of medical
devices, comprising: a system proximal portion comprising a handle
and a stylet slidably disposed therethrough; a middle section
delivery device comprising an elongate outer sheath and an elongate
inner compression member, the outer sheath comprising a proximal
end portion having an opening and a distal end portion having an
opening and defining a passageway therebetween, the outer sheath
proximal end portion being operatively coupled to the handle, and
the inner compression member having a proximal end operatively
coupled to the stylet, a middle section extending through the outer
sheath passageway, and a distal mating end portion; and a system
distal portion comprising an inner guide channel member and an
outer guide channel member, the inner guide channel member
including a distal first end portion having an entry port and a
proximal second end portion having an exit port and defining a
guide channel therebetween, the outer guide channel member axially
slidably receiving the inner guide channel member second end
portion and further comprising a distal first end portion and a
proximal second end portion, an entry port and an exit port
defining a guide channel therebetween, and a stepped profile having
a first outer diameter intermediate the outer guide channel member
first and second end portions and a second smaller outer diameter
located at or near the outer guide channel member second end
portion; wherein the system distal portion and middle section
delivery device are operatively coupled.
15. The device of claim 14 further comprising a self-expanding
deployment device mounting region disposed within the outer guide
channel member and comprising a proximal stent restraint, an inner
guide channel member stent platform, and an outer guide channel
member stent constraining inner surface.
16. The device of claim 15 further comprising a transition region
proximal to the self-expanding deployment device mounting region,
wherein the inner guide channel member exit port is in
communication with the outer guide channel member exit port and
comprising a breech position opening located proximal to the inner
member exit port.
17. The device of claim 14 wherein the guide channel of the inner
guide channel member and the guide channel of the outer guide
channel member are substantially coaxially aligned.
18. The device of claim 14 wherein the inner guide channel member
is tubular and comprises a longitudinal axis, and the outer guide
channel member exit port is substantially aligned with the inner
guide channel member longitudinal axis.
19. The device of claim 18 such that the inner guide channel member
longitudinal axis intersects the outer guide channel member exit
port without the inner guide channel member second end portion
bending more than about 15 degrees.
20. The device of claim 14 wherein the system distal portion and
middle section delivery device are operatively coupled by
operatively coupling the outer guide channel member second end
portion and the outer sheath distal end portion.
21. The device of claim 14 wherein the system distal portion and
middle section delivery device are operatively coupled by
operatively coupling the inner guide channel member second end
portion and the inner compression member distal mating end
portion.
22. The device of claim 14 wherein the system distal portion and
middle section delivery device are operatively coupled by a
bridging device.
23. The device of claim 14 wherein the system distal portion and
middle section delivery device are operatively coupled by an
insert.
24. The device of claim 14 wherein the system distal portion and
middle section delivery device are operatively coupled by an
integrally formed outer sheath and outer guide channel member.
25. A method of using a delivery apparatus for the rapid insertion
of medical devices for intracorporeal procedures, comprising the
steps of: providing a delivery system comprising a system proximal
portion having a handle and a stylet and intended to remain outside
a patient, a middle section delivery device having an outer sheath
with a passageway and an inner compression slidably received within
the outer sheath passageway, and a system distal portion having an
inner guide channel member with a guide channel, an outer guide
channel member axially slideable relative to the inner guide
channel member and having a guide channel substantially aligned
with the guide channel of the inner guide channel member and having
a stepped profile, the system distal portion further comprising a
self-expanding deployment device mounting region, a transition
region, and a proximal breech opening; loading a self-expanding
device in a radially compressed state into the stent mounting
region; sliding the system distal portion over a previously
positioned guiding device; retracting the outer guide channel
member proximally relative to the inner member so as to deploy the
self-expanding device.
Description
RELATED APPLICATIONS
[0001] The present patent document claims the benefit of the filing
date under 35 U.S.C. .sctn.119(e) of United States Provisional
Patent Application filed on Apr. 20, 2005 entitled, "Delivery
System and Devices for the Rapid Insertion of Self-Expanding
Devices," and having an application Ser. No. 60/673,199, the
disclosure of which is hereby incorporated by reference in its
entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to medical devices generally
used percutaneously or through a delivery apparatus (such as an
endoscope) for the delivery of self-expanding devices, as well as
methods of making and using such devices.
BACKGROUND OF THE INVENTION
[0003] This invention relates generally to medical devices and, in
particular, to a delivery system that employs a catheter device for
use with self-expanding devices such as stents, prosthetic valve
devices, and other implantable articles at a selected location
inside a patient's body. More particularly, the device includes a
flexible, kink-resistant middle section having an outer sheath and
inner compression member and having a distal end comprising an
inner guide channel member and an outer guide channel member, the
inner and outer guide channel members being configured to
facilitate rapid insertion of a wire guide and delivery of
self-expanding devices.
Self-Expanding Devices
[0004] Medical delivery and placement systems and tools have grown
out of the need for implanting medical devices in endovascular and
other body lumens of a patient. The present invention relates to
new and useful medical devices generally used percutaneously or
through an apparatus such as an endoscope for delivering a
particular type of implantable medical devices: self-expanding
devices. Types of self-expanding devices include various medical
devices, such as stents, prosthetic valve devices, and other
implantable articles for placement inside a patient's body.
Although use of the present invention is not limited to stents, a
discussion of stent technology provides a general and beneficial
introduction into the variety of self-expanding devices that the
present invention delivers and places in endovascular and other
body lumens.
[0005] Minimally invasive surgical stent technology has become
popular since the introduction of stents to the medical device
market in the United States in the early 1990s. For more than a
decade, stents have proven to provide an excellent means for
maintaining vessel patency, and have become widely accepted in the
medical field.
[0006] By way of background, stents are configured to be implanted
into body vessels having a passageway in order to reinforce,
support, repair, or otherwise enhance the performance of the
passageway. The term "passageway" is understood to be any lumen,
channel, flow passage, duct, chamber, opening, bore, orifice, or
cavity for the conveyance, regulation, flow, or movement of bodily
fluids and/or gases of an animal. As an example, stents have been
used in the passageways of an aorta, artery, bile duct, blood
vessel, bronchiole, capillary, esophagus, fallopian tube, heart,
intestine, trachea, ureter, urethra, vein, and other locations in a
body (collectively, "vessel") to name a few.
[0007] Depending on the vessel in which it is to be implanted, a
stent may come in a variety of different configurations. In
general, a stent may comprise a ring, or stack of rings, each ring
being formed of struts and apices connecting the struts, whereby
the stent defines an approximately tube-like configuration.
Furthermore, the stent perimeter, when viewing the stent end-on,
may define a structure roughly, but not exactly, resembling a round
cylinder if the struts are straight, because the struts follow a
straight line from the apex on one end of the strut to the apex on
the other end of the strut.
[0008] In addition to their having a variety of configurations,
stents also come in different types as defined by the way they
expand. For instance, various types of expandable stents have been
described that are self-expanding, balloon-expandable, or a
combination thereof where the stent is partially self-expanding and
partially balloon-expandable. Expandable stents are normally
evaluated, more or less, with respect to four performance criteria:
the radially outward expansile force that the stent exerts in the
vessel passageway on an interior surface of the vessel; the small
diameter to which the stent is capable of being compressed for the
insertion procedure; the ability of the stent to traverse curved
passageways; and the stability of the stent in being resistant to
migrating from its originally implanted position.
[0009] A balloon-expandable stent is generally mounted on an
expandable member, such as a balloon, provided on the distal end of
a delivery system, such as a catheter or tubular delivery device,
to be discussed more fully below. In operation, a physician or
other healthcare professional (collectively, "physician") inserts
the catheter into and navigates the catheter through a vessel
passageway by advancing the catheter to a desired location adjacent
the target site within the vessel passageway of a patient. In a
subsequent step, the physician pulls back a sheath or other
covering member to withdraw from and releasably expose the stent
for deployment. In another step, the physician inflates the balloon
to plastically deform the stent into a substantially permanent
expanded condition. The physician then deflates the balloon and
removes the catheter or delivery device from the patient's
body.
[0010] For a self-expanding stent, the stent is resiliently
compressed into a collapsed first, smaller diameter, carried by the
delivery system, and due to its construction and material
properties, the stent expands to its second, larger diameter upon
deployment. In its expanded configuration, the stent exhibits
sufficient stiffness so that it will remain substantially expanded
and exert a radially outward force in the vessel passageway on an
interior surface of the vessel.
[0011] One particularly useful self-expanding stent is the Z-stent,
introduced by Cook Incorporated, due to its ease of manufacturing,
high radial force, and self-expanding properties. Examples of the
Z-stent are found in U.S. Pat. Nos. 4,580,568; 5,035,706;
5,282,824; 5,507,771; and 5,720,776, the disclosures of which are
incorporated in their entirety. The Zilver stent, introduced by
Cook Incorporated, is another particularly useful self-expanding
stent due to its nitinol platform and use of the Z-stent design
properties. Examples of the Zilver stent are found in U.S. Pat.
Nos. 6,743,252 and 6,299,635, the disclosures of which are
incorporated in their entirety. By way of example only, one or more
of these designs have been utilized in stents for applications
involving the bronchioles, trachea, thoracic aortic aneurysms
(stent-graft), abdominal aortic aneurysms (stent-graft),
intestines, biliary tract, and prosthetic venous valve devices. The
Z-stent and Zilver stent are capable of being compressed, inserted
into a catheter or delivery device, pushed out into the passageway
of a vessel, and then self-expanded to help keep the vessel
passageway in an open state. A few of the embodiments of devices
using one of these stents are the Zilver.RTM. 518 biliary
self-expanding stent and the Zenith.RTM. AAA Endovascular Graft for
the endovascular treatment of an abdominal aortic aneurysm.
[0012] A stent of the self-expanding type, like the
balloon-expandable type, may assume a collapsed tubular
configuration having a smaller diameter and an expanded tubular
configuration having a larger diameter. In its collapsed smaller
diameter configuration, the stent can be constrained by a delivery
system in order to be positioned in the vessel passageway where
desired. The stent is then deployed by the delivery system and
expanded.
[0013] In both the self-expanding and balloon-expandable types of
stents (and combinations thereof), a delivery system for
percutaneous positioning of the stents in the vessel passageway may
use a wire guide. The physician uses the wire guide to maneuver a
portion of the delivery system through the vessel passageway and to
the desired position therein.
Wire Guide
[0014] A wire guide can be used to place a delivery system, such as
a catheter or tubular delivery device, into a vessel passageway
percutaneously. A physician may use a cannula or a needle as a way
of introducing the wire guide. For instance, the physician may
create an incision in the patient and then position the cannula in
the incision for the insertion of the wire guide. The typical wire
guide has proximal and distal ends. A physician inserts the distal
end into the proximal end of the cannula or needle and then out a
distal end of the cannula or needle, and thus into the vessel
passageway. Once inside the vessel, the wire guide may be advanced
and manipulated until the distal end of the wire guide reaches its
destination. Alternatively, the physician may place the cannula or
needle into any one of a variety of vessels, such as an artery,
bile duct, brachial vein, cephalic vein, or other vessel as
described above, and then may introduce the wire guide through the
needle into the vessel. In subsequent steps, the physician may
withdraw the needle over the wire guide and introduce a guide
catheter over the wire guide and into the patient.
[0015] Regardless of how the physician places the wire guide into a
vessel passageway for use with a traditional delivery system, the
physician must ensure that the catheter or other medical device has
the right length relative to the length of the wire guide.
Consequently, the catheter or other medical device will be inserted
over the wire guide to a precise length inside the patient so that
a distal end of the catheter or other medical device is positioned
at or near the distal end of the wire guide in proximity to a
target site for treatment, diagnosis, or medical intervention.
However, a long, straightened portion of the wire guide will remain
outside of the patient's body and may get caught on outside objects
and disturb the placement of the catheter.
[0016] Additional procedures that involve wire guides often require
exchanging of catheters or medical devices. For example, a catheter
may be used for the delivery of a self-expanding device such as a
stent. In that case, the stent may be deployed, the catheter
withdrawn and reloaded with an additional stent or replaced with a
separate catheter carrying another stent, or even exchanged for a
different medical device. This procedure may prove cumbersome and
time consuming, because as explained below, the overall length of a
wire guide in an over-the-wire delivery system needs to be
substantially longer than the length of the delivery catheter
(e.g., the wire guide may need to be twice as long as the
catheter). Furthermore, the proximal portion of the wire guide
outside the patient's body must remain a sterile field, but as
explained below, when the wire guide needs removing or the catheter
exchanging for another catheter or other medical device, then an
additional person in the operating room needs to hold onto the
proximal end of the wire guide to keep the wire guide straight and
to prevent unintended proximal or distal movement of the wire
guide.
Catheter
[0017] Many delivery systems employ a catheter, sheath, cannula,
introducer, or other medical delivery device or tube-like
structure, which must "slide over" the wire guide yet fit "within"
a guide catheter or a working channel of an endoscope or an
external accessory channel device used with an endoscope
(individually and collectively, "catheter"). The catheter comprises
a lumen for the wire guide. Generally stated, these delivery
systems may fall within two categories. The first category of
delivery systems to have been used, and consequently the first to
be discussed below, is commonly referred to as an "over-the-wire"
catheter system. The other category of delivery systems is
sometimes referred to as a "rapid exchange" catheter system. In
either system, a wire guide is used to position the delivery system
within a vessel passageway. The typical wire guide has proximal and
distal ends. A physician inserts the distal end into the vessel
passageway, advances, and maneuvers the wire guide until the distal
end reaches its desired position within the vessel passageway.
[0018] In the "over-the-wire" catheter delivery system, a physician
places the catheter over the wire guide, with the wire guide being
received into a lumen that extends substantially through the entire
length of the catheter. In this over-the-wire type of delivery
system, the wire guide may be back-loaded or front-loaded into the
catheter. In front-loading an over-the-wire catheter delivery
system, the physician inserts the distal end of the wire guide into
the catheter's lumen at or near the catheter's proximal end. In
back-loading an over-the-wire catheter delivery system, the
physician inserts a distal portion of the catheter over the
proximal end of the wire guide. The back-loading technique is more
common when the physician has already placed the wire guide into
the patient, which is typically the case today. In either case of
back-loading or front-loading an over-the-wire catheter delivery
system, the proximal and distal portions of the catheter will
generally envelop the length of the wire guide that lies between
the catheter first and second ends. While the wire guide is held
stationary, the physician may maneuver the catheter through the
vessel passageway to a target site at which the physician is
performing or intends to perform a treatment, diagnostic, or other
medical procedure.
[0019] Because this delivery system fits over the wire guide, the
replacement or exchange of catheters or medical devices requires
that the portion of the wire guide protruding from the patient's
body be longer than the replacement or exchanged catheter or
medical device. For instance, if 60 centimeters (cm) of the
catheter is to be inserted into the patient, then a wire guide will
need to be slightly longer than approximately 120 cm, because the
physician will need to hold or secure the proximal portion of the
wire guide (i.e., the portion extending out of the body) as the
delivery catheter is being back-loaded onto the wire guide.
Consequently, the overall length of the wire guide may need to be
at least more than 120 cm. Likewise, replacement or exchange of a
catheter or medical device requires that a physician secure the
proximal end of this lengthy wire guide while the catheter is
withdrawn from the patient until the distal end of the catheter is
then slipped off of the proximal end of the wire guide. This
procedure requires a considerable operational time when the
catheter is initially placed over the wire guide for insertion into
the patient and is withdrawn from the wire guide for exchange or
replacement. Furthermore, the extra wire guide length makes control
and manipulation of the wire guide difficult, cumbersome, and
usually requires an extra person in the sterile field of the
procedure to help control and protect the proximal end of the wire
guide.
[0020] Therefore, there is a need for an apparatus that enables a
user to quickly and easily advance a catheter over a wire guide.
The present invention solves these and other problems.
[0021] Another problem with conventional over-the-wire delivery
systems is tendency for the stent-carrying inner catheter to kink
during stent deploment. It should be understood in conceptual terms
how self-expanding devices (such as stents, prosthetic valve
devices, and other implantable articles) are generally deployed
from the delivery system. Using a self-expanding stent as an
example, inner and outer catheters are utilized for delivering the
implantable stent to a deployment site well within the vessel
passageway of the patient. The stent is releasably positioned on a
platform located at the distal end of a stent-carrying inner
catheter. On the platform, the stent is seated axially intermediate
optional distal and proximal radiopaque restraint markers and
sandwiched transversely (i.e., compressed) between the outer
catheter and the inner catheter.
[0022] Typically (using the self-expanding stent for illustration),
the stent-constraining outer catheter is withdrawn proximally over
the stent. As is conventional, "distal" means away from the
physician when the device is inserted into a patient, while
"proximal" means closest to or toward the physician when the device
is inserted into a patient. The outer catheter and inner catheter
must be flexible enough to navigate a vessel passageway. In
particular, the inner catheter may be susceptible to kinking when
the stent-constraining outer catheter is withdrawn to deploy the
self-expanding device, because the self-expanding device exerts
friction and drag on the interior surface of the stent-constraining
outer catheter, owing to the self-expanding device's radially
outward expansile force property as discussed above. Thus, the
self-expanding device and the stent-carrying inner catheter will be
prone to withdraw together with the stent-constraining outer
catheter. As a result, the inner catheter may be prone to kink upon
withdrawal of the outer catheter.
[0023] Therefore, there is a need for an apparatus that enables the
user to withdraw the stent-constraining outer catheter proximally
over the stent without causing the stent-carrying inner catheter to
move proximally or to kink. The present invention solves these and
other problems.
[0024] The present invention has enough flexibility to navigate
through the vessel passageway with an outer catheter, and an inner
compression member has sufficient stiffness to "push" the stent in
order to counter the urge for the stent (or a stent-carrying
catheter) to prolapse proximally with the withdrawing of the outer
guide channel member. As will be understood, "pushing" on the inner
compression member will keep a stent-carrying inner catheter (and
therefore the stent) from translating as a result of an outer
catheter being pulled over the stent; thereby "pushing" holds the
stent in place at the desired deployment site within the patient's
body.
[0025] Another aspect of the present invention is to design the
inner compression member so that it optionally has a dual
functionality. For instance, in addition to being a flexible and
sufficiently stiff member to resist kinking during stent
deployment, the inner compression member in one embodiment also
carries and removes fluids, where the term "fluid" is understood as
including but not limited to gases, air, water, contrast fluid,
oil, saline solution, blood sample, flushing solution, medication,
drug eluting therapeutic substance, or other liquid, gas, fluid, or
medium that is biocompatible or capable of being made
biocompatible.
[0026] Turning now to a delivery system that is sometimes referred
to as a "rapid exchange delivery system," the traditional rapid
exchange delivery system may be prone to the same susceptibility of
kinking as discussed above and, additionally, may be prone to kink
the wire guide as explained below. Like the over-the-wire delivery
system, the conventional rapid-exchange system utilizes an outer
catheter and an inner catheter, which are substantially co-axial.
The conventional rapid-exchange delivery system further comprises a
distal segment with a stent-carrying inner member. Unlike the
over-the-wire system where the wire guide is received into the
lumen of the inner catheter and extends the entire length of the
inner catheter, in the rapid exchange delivery system the wire
guide occupies a catheter lumen extending only through the distal
segment of the outer catheter.
[0027] With respect to the distal segment of the outer catheter in
a traditional rapid exchange delivery system, the wire guide enters
a distal section and, in particular, a lumen of a stent-carrying
inner catheter at a distal opening and exits the stent-carrying
inner catheter at a side opening proximal to the distal opening.
The wire guide in the conventional rapid exchange system bends
substantially and diverges significantly away from the longitudinal
axis of the stent-carrying inner catheter as it converges toward an
exit side port located in an outer wall of a stent-constraining
outer catheter. Thus, the wire guide enters the delivery system at
the distal portion of the inner catheter, exits the side opening in
the inner catheter and the side port of the outer catheter, and
then runs proximally along the outside surface of the outer
catheter wall and is substantially parallel with or "side-by-side"
with the inner catheter.
[0028] The bend that the wire guide goes through, in the
traditional rapid exchange system, as it passes from the lumen of a
stent-carrying inner catheter to the exit side port in the outer
wall of the stent-constraining outer catheter proximately causes
and contributes to added resistance (compared to a wire guide
experiencing substantially no or considerably reduced bending). For
instance, the wire guide turns significantly away from the
longitudinal axis of the lumen of the stent-carrying inner catheter
when the physician withdraws the outer catheter proximally to
remove, replace, or exchange the delivery system with a new
catheter containing another self-expanding stent or a different
medical device. As a result of its bending, the wire guide tends to
kink. A kink in the wire guide may cause difficulty during a later
step where, after the stent is deployed, the outer catheter during
withdrawal catches on the wire guide kink and pulls the distal end
of the wire guide away from the deployment site. Also, after the
delivery system is withdrawn from the proximal end of the wire
guide, the inner catheter may need to be reloaded onto the wire
guide (e.g., with an additional stent, or replaced with a catheter
carrying a different medical device) and will then encounter the
wire guide kink as the inner catheter moves distally.
[0029] Buckling and bowing, as two forms of kinking, of the distal
segment of the device may occur with a traditional design of a
rapid exchange delivery system in the vicinity where the wire guide
exits the inner catheter side opening and turns substantially
transverse to the inner catheter in order to leave the side exit
port of the relatively juxtaposed proximal opening in the
stent-carrying member and the side port in the outer wall of the
stent-constraining outer catheter. Owing to the transverse position
of the side opening in the outer wall of the stent-carrying inner
catheter and the transverse side exit port in the outer wall of the
stent-constraining outer sheath, there is an open cutout profile in
the traditional device that may have a tendency to buckle or bow at
the cutout when traversing within the narrow confines of the vessel
passageway. The tendency to buckle or bow may decrease with a
closure of the cutout by elongating the exit side port in the outer
wall of the stent-constraining outer catheter, but this may cause
weakness in pull strength or bending properties of the outer
catheter. Indeed, the outer catheter and the stent-carrying inner
catheter are basically of thin-wall construction: while increasing
the thickness of the walls at the location of the inner catheter
side opening and the outer catheter exit side port minimally
improves the level of resistance to buckling or bowing, this level
is still often considered unacceptable. In addition, increasing the
thickness of the walls is generally considered undesirable because
it necessitates the use of a larger delivery device or entry hole
in the patient than would otherwise be required (owing to the
increased profile of the catheter). Furthermore, the larger
catheter profile may also cause unnecessary irritation of the
patient's vessel, as well as limiting the size of the vessel in
which the delivery system may operate.
[0030] The present invention solves these and other problems by
providing a breech position opening.
[0031] Another challenge with the traditional design of a rapid
exchange delivery system is proper alignment of the stent-carrying
inner catheter side opening and the exit side port of the
stent-constraining outer catheter. Misalignment may occur during
several steps. For instance, the stent-carrying inner catheter and
the stent-constraining outer catheter may rotate or their relative
axial positions may shift during navigation and positioning of the
delivery system through the vessel passageway. Another example
where misalignment may occur is during the withdrawal of the
stent-constraining outer catheter. As the outer catheter retracts
proximally from the relative position of the stent-carrying inner
catheter to expose and to deploy the stent from the stent-carrying
platform, misalignment may result. Increasing the size of the exit
side port of the stent-constraining outer catheter alleviates some
of the alignment challenges but further increases the problems of
kinking, buckling, bending, and bowing as discussed above.
[0032] Thus, during positioning, operation, repeated use, or
patient movement, the stent-constraining outer catheter may be bent
or shifted axially or rotationally, thereby resulting in a kink in
the sheath or misalignment of the side opening of the
stent-carrying inner catheter and the side exit port of the outer
catheter's outer wall. A kinked or misaligned catheter may become
unusable and, even if useable may be difficult to straighten while
positioned in the body of a patient. Consequently, the sheath must
be manipulated within the patient's vessel passageway, giving rise
to an increased duration in the medical procedure. Alternatively,
the delivery system may need to be removed, leaving an enlarged,
bleeding opening which typically cannot be reused. Vascular access
must then be re-attempted at an alternative site, and the procedure
restarted. This can cause an unnecessary delay of time and, during
emergency procedures, may be life threatening. In addition, in some
cases, an acceptable alternative site is not available for
introducing another delivery device.
[0033] The present invention solves these and other problems by
providing a transition region for an inner guide channel member and
an outer guide channel member.
[0034] Therefore, it would be desirable to have a medical device
delivery system for self-expanding devices such as stents,
prosthetic valve devices, and other implantable articles inside a
patient's body, whereby a flexible, kink-resistant middle section
delivery device has an outer sheath and an inner compression
member, and a distal end of the device comprises an outer guide
channel member and inner guide channel member that comprise a
cooperatively kink-resistant wire guide lumen configured to
facilitate rapid insertion of a wire guide and delivery of a
self-expanding device. Consequently, it is desirable to have
medical systems and rapid insertion delivery devices for the
delivery of self-expanding devices as taught herein, and methods of
making and using such devices.
SUMMARY OF THE INVENTION
[0035] The present invention provides medical device delivery
systems for the rapid insertion of medical devices.
[0036] In one embodiment, an inner guide channel member has a first
end portion having an entry port and a second end portion having an
exit port and a guide channel therebetween and having an outer
surface for a stent platform intermediate the first and second end
portions. A proximal stent restraint is disposed about and
operatively coupled to the inner guide channel member intermediate
the inner guide channel member first and second end portions, and
the stent platform distal the proximal stent restraint and proximal
the inner guide channel member entry port. An outer guide channel
member has first and second end portions defining a channel
therebetween for receiving the inner guide channel member second
portion, wherein the guide channels are substantially aligned.
[0037] In another embodiment, an inner guide channel member has a
first end portion with an entry port and a second end portion with
an exit port and defining a channel therebetween and having a stent
platform intermediate the ports. An outer guide channel member has
first and second portions defining a channel sized to slidably
receive the inner guide channel member second end portion. The
outer guide channel member has a stent constraining surface
disposed about the inner guide channel member stent platform, and
has a stepped profile with a first outer diameter intermediate the
outer guide channel member first and second end portions, and a
second smaller outer diameter near the outer guide channel member
exit port. The exit ports are in fluid communication.
[0038] In still another embodiment, the delivery apparatus includes
a system proximal portion having a handle and stylet. A middle
section delivery device has an elongate outer sheath operatively
coupled to the handle, and an elongate inner compression member
having a proximal end and a distal mating end portion, the inner
compression member proximal end being operatively coupled to the
stylet. A system distal portion has an inner guide channel member
with a first and second end portion defining a channel, an outer
guide channel member axially slidably receiving the inner guide
channel member second end portion. The outer guide channel member
has an entry port and an exit port defining a guide channel
therebetween, and a stepped profile having a first outer diameter
intermediate the outer guide channel member first and second end
portions and a second smaller outer diameter located at or near the
outer guide channel member second end portion. The system distal
portion and middle section delivery device are operatively
coupled.
[0039] In still another embodiment, methods of using a delivery
apparatus for the rapid insertion of medical devices for
intracorporeal procedures are provided. A delivery system is
provided having a system proximal portion having a handle and a
stylet and intended to remain outside a patient, a middle section
delivery device having an outer sheath and an inner compression,
and a system distal portion having an inner guide channel member
and an outer guide channel member having a stepped profile, the
system distal portion further comprising a self-expanding
deployment device mounting region, a transition region, and a
proximal breech opening. A self-expanding device is loaded into a
radially compressed state at the stent mounting region. The system
distal portion is slide over a previously positioned guiding
device. The outer guide channel member is retracted proximally
relative to the inner member so as to deploy the self-expanding
device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0040] FIG. 1 is a schematic view, broken away, of a medical device
system according to one embodiment of the invention.
[0041] FIG. 2 is an exploded side view, broken away, of a proximal
portion of a medical device according to one embodiment of the
invention.
[0042] FIG. 2A shows longitudinally sectioned exploded side views
of a handle first connector and a handle second connector according
to one embodiment of the invention.
[0043] FIG. 2B shows a longitudinally sectioned side view of
operatively coupled first and second connectors according to FIG.
2A.
[0044] FIG. 2C shows a longitudinally sectioned side view of a
handle first connector and a handle second connector according to
FIG. 2B operatively coupling a strain relief member and/or an outer
sheath according to one embodiment of the invention.
[0045] FIG. 3 is a longitudinally sectioned view along a partial
length of an embodiment of a catheter used for an outer sheath of a
middle section delivery device and/or for an outer guide channel
member of a distal portion of a medical device according to the
invention.
[0046] FIGS. 4A and 4B are longitudinal sectional perspective side
views, broken away, of embodiments of an outer sheath for a middle
section delivery device comprising multifilar material.
[0047] FIG. 4C is an alternative embodiment of an outer sheath,
broken away, for a middle section delivery device comprising a
wrapped round coil.
[0048] FIG. 4D is an alternative embodiment of an outer sheath,
broken away, for a middle section delivery device comprising a
cable tubing or spiral cut cannula.
[0049] FIG. 4E is an alternative embodiment of an outer sheath,
broken away, for a middle section delivery device comprising a
cable tubing connected to spiral cut cannula.
[0050] FIG. 4F is an alternative embodiment of an outer sheath,
broken away, for a middle section delivery device comprising a
round braid.
[0051] FIG. 4G is an alternative embodiment of an outer sheath,
broken away, for a middle section delivery device comprising a flat
braid.
[0052] FIG. 5 is a schematic sectional side view, broken away, of
an integral outer sheath of a middle section delivery device and an
outer guide channel member of a distal portion of a medical device
according to the invention.
[0053] FIG. 5A provides a longitudinally sectioned schematic side
view, broken away, of a brace device for use in a middle section
delivery device and/or for bridging the middle section delivery
device and a distal portion of a medical device according to the
invention.
[0054] FIG. 5B shows a cross sectional view of FIG. 5A taken along
the lines 5B-5B.
[0055] FIGS. 5C through 5G show alternative perspective views of a
bridge associating a partial schematic middle section delivery
device and a partial schematic distal portion of a medical device
according to the invention, the bridge comprising a span.
[0056] FIGS. 5H through 5K show perspective schematic views of an
alternative embodiment of a bridge comprising a plurality of
spans.
[0057] FIG. 5L shows an insert having a flared end.
[0058] FIG. 5M shows an alternative embodiment of an insert.
[0059] FIG. 5N shows an embodiment of an insert having
perforations.
[0060] FIG. 5O shows an embodiment of an insert having slots.
[0061] FIG. 5P shows a schematic sectional side views, broken away,
of an outer sheath and an outer guide channel member bridged by
interfacing distal and middle inserts.
[0062] FIG. 5P shows a schematic sectional side views, broken away,
of an outer sheath and an outer guide channel member.
[0063] FIG. 5Q shows a schematic sectional side views, broken away,
of an outer sheath and an outer guide channel member bridged by
interfacing distal and middle inserts.
[0064] FIG. 5R illustrates a sectional side view, broken away, of
an embodiment of an insert according to FIG. 5O secured to one of
the outer sheath of the middle section delivery device or second
end of the outer guide channel member according to the
invention.
[0065] FIG. 5S illustrates a sectional side view, broken away, of
an embodiment of an insert according to FIG. 5N secured to one of
the outer sheath of the middle section delivery device or second
end of the outer guide channel member according to the
invention.
[0066] FIG. 5T illustrates a sectional side view, broken away, of
an embodiment of a bridging insert according to FIG. 5L secured to
one of the outer sheath of the middle section delivery device or
second end of the outer guide channel member according to the
invention.
[0067] FIG. 6 is a longitudinally sectioned view, broken away, of a
distal portion of medical device delivery system according to one
embodiment of the invention.
[0068] FIGS. 6A and 6B schematically represent cross sectional
views of melt bonding according to one embodiment of the invention,
where FIG. 6A shows components before melt bonding while FIG. 6B
shows the components after melt bonding.
[0069] FIG. 7 is a longitudinally sectioned view, broken away, of
an alternative embodiment of a distal portion of a medical device
delivery system according to one embodiment of the invention.
[0070] FIG. 8 is a longitudinally sectioned view of an embodiment
of a distal portion according to the invention, shown having a
portion of a wire guide.
[0071] FIG. 9 is a longitudinally sectioned view, broken away, of
another embodiment of a distal portion of a medical device delivery
system according to one embodiment of the invention.
[0072] FIGS. 9A, 9B, and 9C show cross sectional views of FIG. 9
taken along the lines 9A-9A, 9B-9B, and 9C-9C, respectively.
[0073] FIG. 10 is a longitudinal sectional side view of an
alternative embodiment of a distal portion of a device for the
rapid insertion of self-expanding stents according to the invention
shown in an un-deployed delivery state.
[0074] FIG. 11 is a view of FIG. 10 shown in one illustrative
deployed delivery state.
[0075] FIG. 12 is a cross sectional view of FIG. 10 taken along the
line 12-12.
[0076] FIGS. 13A, 13B, and 13C are alternative embodiments of cross
sectional views of FIGS. 10 and 11 taken along the line 13-13.
[0077] FIGS. 14A, 14B, 14C, 14D, 14E, and 14F are alternative
embodiments of cross sectional views of FIGS. 10 and 11 taken along
the line 14-14.
[0078] FIG. 15 is one embodiment of a cross sectional view of FIGS.
10 and 11 taken along the line 15-15.
[0079] FIG. 16 is a longitudinal schematic sectional side view,
broken away, of a portion of an embodiment of an outer guide
channel member according to FIG. 10.
[0080] FIG. 17 is a longitudinal schematic sectional side view,
broken away, of a portion of an embodiment of an inner compression
member and an inner guide channel member according to FIG. 10.
[0081] FIG. 18 is longitudinal sectional side view of an
alternative embodiment of a distal portion of a device for the
rapid insertion of self-expanding stents according to the invention
shown in an illustrative deployed delivery state, and shown with a
wire guide.
[0082] FIG. 19 is an alternative view of FIG. 18 shown in an
un-deployed delivery state, and shown with a wire guide.
[0083] FIG. 20 is a view of a portion of an embodiment of an outer
guide channel member depicted in FIG. 18.
[0084] FIG. 21 is a longitudinal schematic sectional side view,
broken away, of a portion of an embodiment of an inner compression
member and an inner guide channel member according to FIG. 18.
[0085] FIG. 22 is a longitudinal sectional side view of an
alternative embodiment of a distal portion of a medical device
according to the invention.
[0086] FIG. 23A is a cross sectional view of one embodiment of FIG.
22 taken along the line A-A.
[0087] FIG. 23B is a cross sectional view of one embodiment of FIG.
22 taken along the line B-B.
[0088] FIG. 24 shows a schematic side view of an inner compression
member according to an embodiment of the invention.
[0089] FIGS. 24A, 24B, and 24C show cross sectional views of FIG.
24 taken along the lines A-A, B-B, and C-C, respectively.
[0090] FIGS. 25A through 25C are longitudinal schematic sectional
views, broken away, of alternative embodiments of a distal portion
of a medical device according to the invention.
[0091] FIG. 26 is a block diagram illustrating a method of
providing a delivery system configured for rapid insertion delivery
of self-expanding devices.
[0092] FIG. 27 is a block diagram illustrating a method of
manufacturing an outer sheath, outer guide channel member, and/or
inner guide channel member for use with a delivery system
configured for rapid insertion delivery of self-expanding
devices.
[0093] FIG. 28 is a block diagram illustrating an alternative
method of manufacturing an outer sheath, outer guide channel
member, and/or inner guide channel member for use with a delivery
system configured for rapid insertion delivery of self-expanding
devices.
[0094] FIG. 29 is a block diagram illustrating a method of
assembling a middle section delivery device and distal portion for
use with a delivery system configured for rapid insertion delivery
of self-expanding devices.
DETAILED DESCRIPTION OF EMBODIMENTS
[0095] The present invention relates to medical devices, and in
particular to a delivery system configured for rapid insertion
delivery of self-expanding devices such as stents, prosthetic valve
devices, and other implantable articles inside a patient's body.
For conciseness and ease of description of the embodiments of the
invention, the term "stent" and its variations shall refer
individually and collectively (without limiting the invention) to
all self-expanding devices used with the invention, such as stents,
prosthetic valve devices, and other implantable articles inside a
patient's body. For the purposes of promoting an understanding of
the principles of the invention, the following provides a detailed
description of embodiments of the invention as illustrated by the
drawings as well as the language used herein to describe the
aspects of the invention. The description is not intended to limit
the invention in any manner, but rather serves to enable those
skilled in the art to make and use the invention. As used herein
the terms comprise(s), include(s), having, has, with, contain(s)
and the variants thereof are intended to be open ended transitional
phrases, terms, or words that do not preclude the possibility of
additional steps or structure.
[0096] In FIG. 1, an illustrative embodiment of a delivery system
10 having a host of uses, including for the rapid insertion of
self-expanding stents, is provided. The delivery system 10
comprises a system proximal portion 12, a middle section delivery
device 14, and a system distal portion 13 shown in a partially
deploying position.
System Proximal Portion 12
[0097] In the embodiment shown in FIG. 1, the proximal portion 12
remains outside of the patient's body. The proximal portion 12
comprises a handle 30 and an optional pusher stylet 20.
[0098] FIG. 1 depicts a schematic representation of the handle 30
and the optional pusher stylet 20 shown more particularly in FIG.
2. In general, a handle 30 retracts an outer guide channel member
(discussed below) of the distal portion 13 of the delivery system
10 to deploy an implantable prosthesis such as self-expanding,
balloon expandable, or non-expanding stents, prosthetic valve
devices, and other implantable articles (individually and
collectively, "stent," "stents," "implantable prosthesis," and
"implantable prostheses") at a selected location inside a patient's
body. The handle 30 may comprise any mechanical, electromechanical,
pneumatic, or hydraulic handle configured in communication
with--directly or indirectly through intervening parts--the distal
portion's outer guide channel member. Communication would include,
by way of illustration and not by way of limitation, a handle 30
that uses or is otherwise associated with, directly or indirectly,
an elongated mechanical wire, rod, shaft, cable, sheath, pneumatic
tube, or hydraulic pistons, cylinders and/or flow paths configured
for moving the outer guide channel member proximally in order to
deploy a stent.
[0099] FIG. 2 provides a schematic view, broken away, of a delivery
system 10 for rapid insertion of self-expanding stents, but could
be used with other implantable prostheses described above. The
delivery system 10 shown in FIG. 2 is one embodiment of the
proximal portion 12, middle section delivery device 14, and distal
portion 13 shown in a partially deploying position. The middle
section delivery device 14 extends distally from the proximal
portion 12, and a distal portion 13 extends to a position that is
distal the middle section delivery device 14. More particularly,
FIG. 2 shows an exploded view of the proximal portion 12 of the
delivery system 10 according to one embodiment of the invention,
with an emphasis on the handle 30 and the optional stylet 20.
Features of one embodiment of a handle 30 and pusher stylet 20 are
discussed below.
[0100] The handle 30 comprises any tubular structure having a
distal aperture 30'' and a proximal aperture 30', the apertures
defining a chamber 31 therebetween. In general, the handle 30 is a
component, instrument, mechanism, tool, device, apparatus, or
machine configured for directly or indirectly retracting an outer
guide channel member (discussed below) of the distal portion 13 of
the device to expose and, ultimately, to deploy a stent at a
selected location inside a patient's body.
[0101] The handle 30 is axially slideable relative to an elongate
(long) inner compression member 41 that comprises a proximal end 40
and a middle section 40'. As discussed more fully below, the inner
compression member 41 helps to keep the stent from moving
proximally with proximal movement of the handle 30, which handle
movement causes the outer guide channel member to withdraw
proximally over the stent in order to expose and thereby to deploy
the stent. Thus, the inner compression member helps to "push" the
stent or stent carrying inner guide channel member in order to
counter the urge for the stent or stent carrying member to prolapse
proximally with the withdrawing of the outer guide channel member.
As will be understood, "pushing" on the inner compression member
will keep the stent carrying inner guide channel member (and
therefore the stent) from translating as a result of an outer
sheath or outer guide channel member being pulled over the stent;
thereby "pushing" holds the stent in place at the desired
deployment site within the patient's body. In one embodiment, the
handle 30 is a unidirectional handle that is axially slideable
relative to the inner compression member 41 and/or the optional
pusher stylet 20 in order to deploy a stent. In one embodiment, the
inner compression member 41 is secured to a pusher stylet 20.
[0102] As shown in FIG. 2, one embodiment of a pusher stylet 20
comprises a proximal end 20', a distal end 20'', and a cannula 23
intermediate the proximal and distal ends 20', 20'', respectively,
and a receptacle 22. The cannula 23, as should be understood,
comprises any suitable hollow plastic or metal tube. As a hollow
tube, the cannula 23 optionally allows the inner compression member
41 to pass proximally through the cannula 23 and to the proximal
end 20' so that the inner compression member proximal end 40 (such
as a flared proximal end 40) may secure to a plug 21 that fits
within the receptacle 22, wherein FIG. 2 shows the proximal end
20', plug 21, and an optional securing material 28 are shown in an
exploded view relative to the receptacle 22 into which they may be
secured. Furthermore, the cannula 23 assists with keeping that
portion of the inner compression member substantially straight.
[0103] The stylet 20 is optional, because in an alternative
embodiment the physician may hold the inner compression member
proximal end 40' directly in order to "push" (e.g., hold
substantially stationary) the stent carrying inner guide channel
member (and therefore the stent). This controls the stent carrying
inner guide channel member and stent from translating as a result
of an outer sheath or outer guide channel member being pulled over
the stent, so that the stent remains at the desired deployment site
within the patient's body. Alternatively, the stylet 20 is any
stationary handle secured to the inner compression member 41 for
achieving the "pushing" (e.g., hold substantially stationary) of
the stent or stent carrying inner guide channel member while the
outer sheath or outer guide channel member are moved
proximally.
[0104] The stylet distal end 20'' is housed within the handle
chamber 31 and is flared or otherwise flanged sufficiently to be
larger than the handle proximal aperture 30' so as not to pull out
of the chamber 31. In one embodiment, the stylet distal end 20'' is
secured to the distal portion of the stylet cannula 23, while in
another embodiment the stylet distal end 20'' is formed integral
with the distal portion of the stylet cannula 23. Consequently, the
stylet distal end 20'' functions as a proximal stop that prevents
the stylet cannula 23 from backing all the way out the handle while
being axially slideable within the handle chamber 31. Thus, the
stylet 20 will not slide off the handle 30, if so desired. The
stylet distal end 20'' may also, in one embodiment, function as a
distal stop against a restraint 33 formed in the handle chamber 31
intermediate the handle proximal and distal apertures 30', 30'',
respectively, where intermediate should be understood to be any
position between, and not necessarily equidistant to, the handle
apertures 30', 30''. As a result of the stylet distal end 20'', the
handle 30 may slide axially the distance separating the handle
restraint 33 and the stylet distal end 20'', which has a maximum
distance of when the stylet distal end 20'' is abutting the handle
proximal aperture 30'.
[0105] A threaded tapered plug 21 and threaded tapered receptacle
22 optionally secure the inner compression member proximal end 40.
In one embodiment, the inner compression member proximal end 40 is
flared. Securing material 28, such as glue, adhesives, resins,
welding, soldering, brazing, chemical bonding materials or
combinations thereof and the like (collectively and individually,
"glue") may be used to keep the threaded tapered plug 21 from
backing out of the threaded tapered receptacle 22. A portion of the
cannula 23 and stylet distal end 20'' are received within the
handle chamber 31 distal to the handle proximal aperture 30' as
previously explained.
[0106] By optionally placing the inner compression member proximal
end 40 in mechanical communication with the plug 21 and receptacle
22, the gripping and "pushing" (e.g., hold substantially
stationary) on the stylet 20 (e.g., the receptacle 22) thereby
helps to keep the inner compression member 41 from moving away from
the distal portion 13 and, accordingly, counters the tendency for a
stent or stent carrying member to move proximally during withdrawal
of the outer guide channel member as will be explained below. Of
course, the inner compression member may be secured elsewhere by
the stylet 20, such as at or near the stylet distal end 20'' or
intermediate the stylet proximal and distal ends 20', 20'',
respectively, and the stylet distal end 20'' may extend to a
position at or near the distal end aperture 30'' of the handle
30.
[0107] FIG. 2 shows a middle section 40' that extends distally from
the proximal end 40 of the inner compression member 41. In one
embodiment, the middle section 40' passes through the handle 30
(and may pass through the cannula 23 and/or bushings housed within
the handle chamber 31 or other portions of the proximal portion
12). In one embodiment, the middle section 40' is elongate (at
least 50.0 cm or longer as described below) and extends to a
distance distally of the handle 30 and to a position at or near the
medical system delivery device distal portion 13. It should be
understood that, by describing the middle section 40' as passing
through the handle 30, the middle section 40' does not necessarily
need to pass proximally through the entire length of the handle 30,
such as in an embodiment (by way of example and not by way of
limitation) where the proximal end 40 of the inner compression
member 41 is secured to a distal portion of the cannula 23 and/or
the stylet distal end 20'' extending within the handle chamber 31
to a position at or near the handle restraint 33.
[0108] In addition to holding a threaded tapered plug 21 and
optionally the proximal end 40 of the inner compression member 41,
the threaded tapered receptacle 22 may secure the proximal portion
of the optional cannula 23. Glue 28' may be used at or near an
interface of the cannula 23 and distal aperture of the threaded
tapered receptacle 22. The glue 28' serves many functions, such as
to keep dust from settling within the threaded tapered receptacle
22, to make the cannula 23 easier to clean, and to give aesthetics
and a smooth feel to the device.
[0109] The handle 30 slidably receives the distal portion of the
cannula 23 within the handle aperture 30' and handle chamber 31. As
a result, the handle 30 is slidable relative to the stylet 20
(e.g., slidable relative to the threaded tapered plug 21, threaded
tapered receptacle 22, and the cannula 23). In use, the physician
grips the handle 30 in one hand and grips the stylet 20 (e.g., the
receptacle 22) in the other hand. The physician holds the stylet 20
relatively stationary, which prevents the inner compression member
and inner guide channel member and its stent carrying portion from
moving proximally, and then withdraws the handle 30 proximally
relative to the stationary stylet 20 and inner compression member
41. As a result, the physician is thereby retracting an outer guide
channel member (discussed below) of the distal portion 13 of the
delivery system 10 to expose and, ultimately, to deploy a stent
locatable at the distal portion 13 of the delivery system 10. The
handle 30 is in communication with--directly or indirectly through
intervening parts--the outer guide channel member at the distal
portion 13.
[0110] As shown in FIG. 2, some of those optional parts may include
the following: a first bushing 36 having an optional first bushing
flange 35; a second bushing 36' having an optional second bushing
flange 35'; an intermediate seal 37 intermediate the first and
second bushing flanges 35, 35', respectively; a second seal 37'
intermediate the second bushing flange 35' and a check flow body
38; and a detachable cap 39, such a Luer cap by way of example but
not by way of limitation. In one embodiment, one or both of the
intermediate seal 37 and the second seal 37' is from a class such
as an O-ring. In another embodiment, one or both of the
intermediate seal 37 and the second seal 37' is a cylinder or disk
with a center aperture, and may be made from material that
comprises an O-ring. The bushings 36, 36' are hollow plastic or
metal tubes that take up space within the handle 30 so that the
inner compression member has less room to buckle. Fully assembled
in one embodiment, the first bushing 36 is inserted within the
cannula 23 and the first bushing flange 35 is distal to and
abutting the handle restraint 33, which is sized to interfere with
the bushing flange 35 to prevent the bushing flange 35 from moving
proximal to the handle restraint 33. The second bushing flange 35'
is distal to and optionally abutting the bushing flange 35 so to
prevent it from moving proximal the first bushing flange 35, and
the second bushing 36' is inserted within an opening 139 of the
check flow body 38. The intermediate seal 37 and the second seal
37' help to prevent fluids that could be used with the device
(discussed below) from entering the handle chamber 31, which
directs fluids distally, which fluids may be conveyed through an
outer sheath 50 of the middle section delivery device 14 and system
distal portion 13. In one embodiment, the handle restraint 33 is
from a class such as a counterbore wherein the restraint 33
comprises, by way of example only and not by way of limitation, a
flat-bottomed cylindrical enlargement of the handle chamber 31
sized for receiving a first bushing flange 35, an intermediate seal
37, a second bushing flange 35', and/or a check flow body proximal
mating end 38'' intermediate the restraint 33 and the handle distal
aperture 30''.
[0111] The handle 30 and check flow body 38 operatively couple with
the handle distal aperture 30'' receiving a check flow body
proximal mating end 38'' and being secured together by any suitable
means, including but not limited to a crimp, friction fit, press
fit, wedge, threading engagement, glue, adhesives, resins, welding
(laser, spot, etc.), soldering, brazing, adhesives, chemical
bonding materials, or combinations thereof. In one embodiment, the
handle 30 comprises a coupling member 32 and the check flow body
proximal mating end 38'' comprises a coupling member 32', the
coupling members 32, 32' being complementary to hold the handle 30
and check flow body proximal mating end 38'' together. In one
embodiment, the coupling members 32, 32' may form complementary
threads. If it is desired to achieve quicker assembly for
manufacturing purposes, then the coupling members 32, 32' may be an
array of circumferential ridges that form an interference fit when
pressed together. If a one-time snap fit is desired, then the
coupling members 32, 32' may be circumferential ridges in the form
of barbs. In another embodiment, the handle 30 and check flow body
proximal mating end 38'' may be put together and taken apart for
servicing, in which case the coupling members 32, 32' may be
circumferential ridges in the form of knuckle threads (e.g.,
circumferential ridges forming complementary undulating waves). The
operatively coupled handle 30 and check flow body proximal mating
end 38'' according to these embodiments may be fixed such that they
do not rotate relative to each other, or may rotate while
preventing undesired axial separation.
[0112] During use, the detachable cap 39 may be detached or opened
and the device flushed with saline to remove air in order to help
keep air out of the patient. The intermediate seal 37 and the
second seal 37' ensure that any flushed fluid moves distally in the
device and does not back up into the handle 30, such as between the
handle restraint 33 and the first bushing 36, into the handle
chamber 31, or out the handle proximal aperture 30'. The detachable
cap 39 (such as a Luer cap) keeps saline from backing out of the
check flow body 38, air from flowing into the check flow body 38,
and blood from rushing out during periods of high blood pressure
inside the patient.
[0113] The medical device delivery systems 10 may be used to deploy
an implantable prosthesis that is a balloon expandable or
self-expanding stent, prosthetic valve device, or other implantable
articles provided on the distal portion of a delivery system. In
operation, a physician inserts the distal portion and at least a
portion of the middle section delivery device into a vessel
passageway, and advances them through the vessel passageway to the
desired location adjacent the target site within the vessel
passageway of a patient. In a subsequent step, the physician moves
the handle proximally, which withdraws the outer sheath and/or the
outer guide channel member and releasably exposes the stent for
deployment. In another step, the physician inflates the expandable
member, such as a balloon, positioned under the stent inner surface
to plastically deform the stent into a substantially permanent
expanded condition. The physician may inflate the expandable member
by injecting fluid such as saline from a syringe into the inner
compression member 41, via pusher stylet 20, through a Luer fitting
at the proximal end 20'. Therefore, the fluid is directed distally
to the expandable member, filling the expandable member chamber and
expanding the stent. The physician then deflates the balloon and
removes the catheter or delivery device from the patient's
body.
[0114] In one embodiment as shown in FIG. 2, the handle 30 further
comprises a check flow body distal mating end 38' and a connector
cap 39' (optionally detachable) secured to the check flow body
distal mating end 38', and a strain relief 29. In one embodiment,
the connector cap 39' is from a class of fasteners such as nuts,
and in one embodiment is a flare nut. The connector cap 39'
functions to hold (or assist in holding in combination with the
check flow body distal mating end 38') a flared proximal portion of
an outer sheath 50 and/or a flared strain relief 29 disposed about
(and optionally extending proximally from) that held portion of the
outer sheath 50. The strain relief member 29 provides a kink
resistant point where the outer sheath 50 connects to the connector
cap 39' and/or the check flow body distal mating end 38'.
[0115] The check flow body distal mating end 38' and connector cap
39' may be operatively coupled mechanically, chemically, and/or
chemical-mechanically. In one embodiment, the connector cap 39' is
crimped, friction fitted, press fitted, and/or wedged into
engagement onto the check flow body distal mating end 38'. In
another embodiment for example, the check flow body distal mating
end 38' and connector cap 39' are operatively coupled by glue,
adhesives, resins, welding (laser, spot, etc.), soldering, brazing,
adhesives, chemical bonding materials, or combinations thereof.
[0116] According to FIG. 2A, yet another embodiment of the
connector cap 39' comprises a handle first connector 130 and the
check flow body distal mating end 38' comprises a handle second
connector 132. According to FIG. 2A, the handle first and second
connectors 130, 132, respectively, function to operatively couple a
strain relief member 29 operatively coupled to the proximal portion
of the outer sheath 50 (discussed below). In one embodiment, the
handle first connector 130 is from a class of fasteners such as
nuts, and in one embodiment is a flare nut. Optionally, the distal
portion of the second bushing 36' is sized (but for the second
bushing flange 35') to be received within a check flow body
proximal opening 139 in communication with the second connector
132.
[0117] FIG. 2A shows an exploded longitudinally sectioned side view
of one embodiment of a portion of the handle comprising a first
connector 130 and a second connector 132. The handle first
connector 130 further comprises a proximal portion 134 and a distal
portion 136. An opening 138 at the proximal portion 134 and an
opening 140 at the distal portion 136 and define a lumen 133
therebetween. There is an engaging surface 142 at or near the
distal portion 136. A threaded first piece 146 is disposed within
the lumen 133 and intermediate the handle first connector distal
end opening 140 and proximal end opening 138. The handle second
connector 132 further comprises a proximal portion 135 and a distal
portion 137. An opening 141 at the distal portion 137 and check
flow body proximal opening 139 (e.g., FIG. 2) at the proximal
portion 135 define a lumen 131 therebetween. There is an engaging
surface 143 at or near the distal portion 137. A threaded second
piece 145 is disposed on the outside surface and intermediate the
handle second connector distal end opening 141 and the check flow
body proximal opening 139.
[0118] According to one embodiment shown in FIGS. 2A and 2B, the
second connector distal portion 137 is received within the first
connector proximal end opening 138. The first connector 130 and
second connector 132 are operatively coupled by a threading
engagement between the first connector threaded first piece 146 and
the second connector threaded second piece 145. Alternatively, the
first connector 130 and second connector 132 are operatively
coupled mechanically, chemically, and/or chemical-mechanically. In
one embodiment for example, the first connector 130 and second
connector 132 are crimped, friction fit, press fit, and/or wedged
into engagement. In another embodiment for example, the first
connector 130 and second connector 132 are operatively coupled by
glue, adhesives, resins, welding (laser, spot, etc.), soldering,
brazing, adhesives, chemical bonding materials, or combinations
thereof.
[0119] FIG. 2B shows the second connector threaded second piece 145
operatively coupled to the first connector threaded first piece 146
such that the second connector proximal portion 135 is proximal to
the first connector proximal portion 134 and the second connector
distal portion 137 is located at or near the first connector distal
portion 136. As shown in FIG. 2B, the second connector engaging
surface 143 is spaced proximal to the first connector engaging
surface 142 for receiving and compressing a strain relief member
second end portion therebetween.
[0120] FIG. 2C shows one embodiment of an optional strain relief
member 29 comprising a tubular first end portion 118 and a flared
second end portion 117. According to FIG. 2C, the medical device
delivery system includes an elongate outer sheath 50 (e.g., FIGS.
2, 2C, 3, 4A-4G, 5M, 5R-5T, 6, 7, 8, 9, 10-11, 18-19, 25A-25D).
Like elements from the previous drawings, embodiments, and
description from above are labeled the same. The term elongate is
used, not lexicographically but instead, to describe embodiments
according to the embodiment that measures at least about 50.0 cm or
measures within one of the ranges of lengths exceeding 50.0 cm and
as more fully discussed above.
[0121] More particularly, FIG. 2C shows that the outer sheath 50
comprises a proximal end portion 57 and a distal end portion 58.
The distal end portion 58 comprises an opening 52 and the proximal
end portion 57 comprises an opening 53; the openings define a
passageway 59 therebetween. In one exemplary embodiment according
to FIG. 2C, the strain relief member tubular first and second end
portions 118, 117, respectively, are disposed about and operatively
coupled to the outer sheath proximal end portion 157. In another
embodiment, the tubular first end portion portion 118 disposes
about the outer sheath proximal end portion 157 while the flared
second end portion portion 117 extends proximally from outer sheath
proximal end portion 157. In addition, the strain relief member
second end portion portion 117 and/or outer sheath proximal end
portion 57 comprise an opening 123 in fluid communication with the
outer sheath passageway 59.
[0122] By way of example only and not by way of limitation, the
terms "operatively coupling," "operatively coupled," "coupling,"
"coupled," and variants thereof are not used lexicographically but
instead are used to describe embodiments of the invention having a
point, position, region, section, area, volume, or configuration at
which two or more things are mechanically, chemically, and/or
chemical-mechanically bonded, joined, adjoined, connected,
associated, united, mated, interlocked, conjoined, fastened, held
together, clamped, crimped, friction fit, pinched, press fit tight,
nested, wedged, and/or otherwise associated by a joint, a junction,
a juncture, a seam, a union, a socket, a melt bond, glue,
adhesives, resins, welding (laser, spot, etc.), soldering, brazing,
adhesives, chemical bonding materials, implanted arrangement, or
combinations thereof.
[0123] FIG. 2C shows the strain relief member second end portion
117 and/or outer sheath proximal end portion 57 being operatively
coupled between the first connector 130 and the second connector
132, and the second connector lumen 131 being in fluid
communication with the outer sheath passageway 59. In one
embodiment, the strain relief member second end portion portion 117
and/or outer sheath proximal end portion 57 comprises a first
opposing surface 124 and a second opposing surface 125. The first
connector engaging surface 142 is disposed against the first
opposing surface 124 and the second connector engaging surface 143
is disposed against the second opposing surface 125, whereby the
strain relief member second end portion 117 and/or outer sheath
proximal end portion 57 becomes operatively coupled between the
first and second connector engaging surfaces 142, 143,
respectively. In one embodiment, the operatively coupled strain
relief member second end portion 117 and/or outer sheath proximal
end portion 57 is compressed (e.g., sandwiched) between the first
and second connector engaging surfaces 142, 143.
[0124] Thus, the check flow body 38 provides an optional three way
connector. The check flow body proximal mating end 38'' and handle
coupling member 32 are operatively coupled. The side port is
controlled by the detachable connector cap 39. The body distal
mating end 38' is operatively coupled to a second connector cap
39', or optionally the handle second connector 132 is received
within and operatively coupled to a handle second connector cap
130.
[0125] The foregoing description of a proximal portion 12 of a
medical device delivery system 10 according to one embodiment of
the invention may be one assembly during shipping, or may include a
two-part assembly or more. Otherwise stated, the stylet 20 and
handle 30 may be sold already combined or may be combined after
purchase by inserting the stylet cannula 23 into the handle at the
hospital via the threaded tapered plug 21 and threaded tapered
receptacle 22. An optional safety lock 34 helps to ensure against
unintentional actuation by preventing distal movement of the stylet
distal end 20'' by extending inwardly within the handle chamber 30
through a slot in the handle outer wall distal to the handle
proximal aperture 30'. Consequently, the optional safety lock 34
thereby maintains the handle 30 in an undeployed position until the
physician is ready to deploy an implantable prosthesis (e.g., a
self-expanding, balloon expandable, or non-expanding stent;
prosthetic valve devices, and other implantable articles) at a
selected location inside a patient's body.
Middle Section Delivery Device 14
[0126] A delivery system 10 as shown in FIGS. 1 and 2 comprises a
middle section delivery device 14. According to the invention, the
middle section delivery device 14 is intermediate the proximal
portion 12 (FIGS. 1, 2) and the distal portion 13 (FIGS. 1, 2) of
the delivery system 10. The term "intermediate" is intended to
describe embodiments of the invention whereby the middle section
delivery device 14 is intermediary, intervening, lying or occurring
between two extremes, or spatially in a middle position, state, or
nature--though not necessarily equidistant--between the distal tip
of the distal portion 13 and the proximal tip of the proximal
portion 12. Furthermore, the middle section delivery device 14 may
overlap or be partially inserted into a portion of the distal
portion 13 and/or the proximal portion 12. In another embodiment, a
portion of the middle section delivery device 14 (such as the
sheath 50 explained below) and the distal portion outer guide
channel member 80 (e.g., FIGS. 5M, 6, 7, 8, 9, 10-11, 16, 18-20,
22, 25A-25D) may be an elongate tubular catheter or Flexor.RTM.
sheath of integral construction.
[0127] According to the invention, a middle section delivery device
14 is a flexible, elongate (long, at least about 50.0 centimeters
("cm")) tubular assembly. In one embodiment, the middle section
delivery device 14 is from approximately 100.0 centimeters ("cm")
to approximately 125.0 cm for use when placing a distal portion 13
of the invention within a patient's body, although it may be sized
longer or shorter as needed depending on the depth of the target
site within the patient's body for delivering the stent. The term
"tubular" in describing this embodiment includes any tube-like,
cylindrical, elongated, shaft-like, rounded, oblong, or other
elongated longitudinal shaft extending between the proximal portion
12 and the distal portion 13 and defining a longitudinal axis. As
used herein and throughout to describe embodiments of the
invention, the term "longitudinal axis" should be considered to be
an approximate lengthwise axis, which may be straight or may at
times even be curved because the middle section delivery device 14,
for instance, is flexible and the distal portion 13 also may be
substantially or partially flexible.
[0128] A middle section delivery device 14 comprises an outer
sheath 50 (e.g., FIGS. 2, 2C, 3, 4A-4G, 5M, 5R-5T, 6, 7, 8, 9,
10-11, 18-19, 25A-25D). FIG. 2C shows that the outer sheath 50 is
generally tubular and comprises a proximal end portion 57 and a
distal end portion 58 and defining a passageway 59 therebetween
(e.g., FIG. 2C). In one embodiment, the distal end portion 58
comprises an opening 52 and the proximal end portion 57 comprises
an opening 53, which openings define the passageway 59. The middle
section delivery device 14 further comprises an elongate inner
compression member 41 (e.g., FIGS. 2, 2C, 6, 7, 8, 9, 9A-9C, 10,
11, 17-19, 20, 22, 24-24B). The outer sheath passageway 59 is
configured for slidably receiving the inner compression member 41,
a catheter, or other medical device.
[0129] FIG. 3 depicts an enlarged, longitudinally sectioned view
along a partial length of one embodiment of an outer sheath 50 for
use as the middle section delivery device 14, with the delivery
system's proximal and distal portions 12, 13, respectively, of the
device being removed for clarity. In one embodiment, the outer
sheath 50 comprises three layers: an inner layer 44 comprising
Teflon material; a middle layer comprising a stainless steel
circumferential spiral coil 43; and an outer layer 42 comprising a
nylon, a polyether block amide ("PEBA"), and/or other melt bonding
material discussed below. The outer layer 42 and inner layer 44
optionally may comprise a lubricious material, one example of which
includes a fluorocarbon such as polytetrafluoroethylene (PTFE), to
present a slideable surface to allow easier inserting and
retracting the middle section delivery device 14 for deploying a
self-expanding stent, as will be explained later.
[0130] The wall of the inner layer 44 of the outer sheath 50 has
sufficient radial rigidity to decrease any tendency of bulging,
kinking, and the like under an internal radial expansile force. In
other words, the inner layer 44 resists an inner object from
protruding or becoming embedded into the inner layer 44, which is
beneficial to the slideability of an outer sheath 50. The coil 43
may be compression fitted or wound around the inner layer 44. The
coil 43 includes a plurality of turns, and preferably includes
uniform spacings 43' between the turns of the coil 43. The coil 43
may be formed of any suitable material that will provide
appropriate structural reinforcement, such as stainless steel flat
wire or biologically compatible metals, polymers, plastics, alloys
(including super-elastic alloys), or composite materials that are
either biocompatible or capable of being made biocompatible.
[0131] Although the embodiment in FIG. 3 shows a flat ribbon shaped
wire coil 43, coils of other cross-sectional dimensions, such as
round wire, may also be used. When flat wire stainless steel is
used, the coil 43 is optionally formed from wire that is about
0.003 inches thick by about 0.012 inches wide. In one embodiment,
the turns of coil 43 are uniformly spaced 43' apart by
approximately 0.0118 inches. While FIG. 3 shows an embodiment that
uses coils 43 having uniformly spaced turns and a constant pitch,
this is not required and coils 43 may be spaced 43' by non-uniform
distances or at varying distances. In one embodiment, the ends of
coil 43 are positioned approximately 0.197 inches proximal to the
distal portion 13 and approximately 0.591 inches distal to the
proximal portion 12.
[0132] The outer sheath 50 for use with the middle section delivery
device 14, and the outer guide channel member 80 (e.g., FIGS. 5M,
6, 7, 8, 9, 10-11, 16, 18-20, 22, 25A-25D) and/or the inner guide
channel member 70 (e.g., FIGS. 6, 7, 8, 9, 10-11, 17-19, 21, 22,
25A-25D) for use with the distal portion 13, are available for
purchase from Cook Incorporated, of Bloomington, Ind. under the
trade name of "Flexor.RTM.." Examples of the Flexor.RTM. sheath
devices, materials, and methods of manufacturing them are found in
U.S. Pat. Nos. 5,700,253 and 5,380,304, the contents of which are
incorporated herein by reference. The Flexor.RTM. sheath is
particularly suited for the outer sheath 50 of the middle section
delivery device 14 and/or the outer guide channel member 80 of the
distal second end portion 13 due to its thin PTFE liner on the
inside wall of the inner layer 44, thin flat wire coil 43, and
Nylon and/or PEBA overcoat 42 that captures the coil 43 and PTFE
liner 44 and binds the structure together. The PTFE inner layer 44
of the Flexor.RTM. sheath resists an expansile inner object from
protruding or becoming embedded into the inner layer 44 and,
thereby, provides a slick, smooth surface that slides (e.g., across
the surface of a stent if the Flexor.RTM. sheath is used with the
distal portion 13 or across the surface of an inner compression
member 41 if the Flexor.RTM. sheath is used with the middle section
delivery device 14) relatively easily when retracted to expose,
release, and deploy the stent or allow the outer sheath 50 to move
relative to the inner compression member 41, and the outer guide
channel member 80 to move relative to the inner guide channel
member 70, during deployment of the stent.
[0133] As an alternative to purchasing the outer sheath 50 for use
with the middle section delivery device 14 and the outer guide
channel member 80 for use with the distal portion 13 from Cook
Incorporated, one may manufacture the outer sheath and outer guide
channel member from various component parts. For instance, one may
purchase a tubular inner layer 44 comprising a lubricious material
comprising a fluorocarbon such as polytetrafluoroethylene (PTFE or
Teflon) from Zeus, Inc. in Orangeburg, S.C., and dispose that inner
layer 44 over a mandrel. Alternatively, a sheet of material
comprising Teflon may be positioned on a mandrel and formed into a
tubular body for the inner layer 44 by any suitable means known to
one skilled in the art.
[0134] The tubular inner layer 44 (whether formed from a sheet on a
mandrel or purchased as a tube and slid onto a mandrel) may be
slightly longer than the desired length described above for the
outer sheath 50 and/or outer guide channel member 80, and slightly
longer than the mandrel. In one embodiment, the tubular inner layer
44 may extend about 5.0 cm from each mandrel end. As explained
below, the "loose" ends of the tubular inner layer 44 help during
manufacturing of the device.
[0135] The mandrel-tubular inner layer 44 assembly is prepared for
a middle layer comprising a stainless steel circumferential spiral
coil 43 as described above and available for purchase from Cook
Incorporated or Sabin Corporation in Bloomington, Ind. As
purchased, the coil 43 comes in a long, pre-coiled configuration
and will be cut by hand or machine to the desired length either
before or after winding the coil about the inner layer 44 to the
desired length. As an alternative, one may manufacture the coil
from raw material available from Fort Wayne Medical in Fort Wayne,
Ind., and process it into a spiral coil 43 shape.
[0136] The operator may apply the spiral coil 43 about the
mandrel-tubular inner layer 44 assembly by hand or machine. If by
hand, then an end of the spiral coil 43 may be started onto the
tubular inner layer 44 by any suitable means, for example, such as
hooking and winding (e.g., wrapping) the coil 43 around the tubular
inner layer 44 in a pigtailed manner at an initial position a
desired distance (e.g., 5.0 cm or more) from a first end of the
tubular inner layer 44 and to a terminating position that is a
desired distance (e.g., 5.0 cm or more) from a second end of the
tubular inner layer 44, and then cutting the coil 43 at the
terminating position before or after hooking the coil 43 onto the
inner layer 44. If by machine, then chucks, for instance, may hold
the opposing ends of the mandrel-tubular inner layer 44 assembly
while the spiral coil 43 is threaded through an arm on a machine
and started onto the tubular inner layer 44 at the initial position
as described above. As the chucks rotate, the inner layer 44
rotates, and the arm moves axially down the length of the inner
layer 44, thereby applying the coil 43 in a spiral configuration
about the inner layer 44. The machine arm moves to a terminating
position where the machine or operator cuts the coil before or
after hooking the coil 43 onto the inner layer 44.
[0137] An operator then applies an outer layer 42 about the
coil-inner layer-mandrel assembly. The outer layer 42 may comprise
a polyether block amide, nylon, and/or a nylon natural tubing
(individually and collectively, "PEBA" and/or "nylon"). The outer
layer 42 preferably has a tubular configuration that disposes about
(e.g., enveloping, surrounding, wrapping around, covering,
overlaying, superposed over, encasing, ensheathing, and the like) a
length of the coil-inner layer-mandrel assembly.
[0138] Heat shrink tubing, available from many suppliers, including
Zeus, Inc. in Orangeburg, S.C. for instance and also Cobalt
Polymers in Cloverdale, Calif., may be disposed about the outer
layer-coil-inner layer-mandrel assembly. Heating the assembly
causes the outer layer 42 to melt. The inner surface of the outer
layer 42 thereby seeps through spaces 43' in or between middle
layer coils 43 and bonds to both the outer surface of the inner
layer 44 and the coils 43. In one embodiment, the inner surface of
the outer layer 42 forms a melt bond 47 (explained below) to the
outer surface of the inner layer 44. Upon cooling, a solid-state
bond results such that the assembly comprises the three layers
discussed above. The operator removes the shrink wrap (e.g., by
cutting) and withdraws the mandrel. The operator may cut the
Flexor.RTM. sheath to a desired length for an outer sheath 50
and/or outer guide channel member 80.
[0139] The temperature, total rise time, and dwell time for the
heat shrink-outer layer-coil-inner layer-mandrel assembly will vary
depending on many factors including, for instance, the actual melt
bonding material that the outer layer 42 comprises, and also the
diameter of the desired Flexor.RTM. sheath. For example, the baking
parameters for a 2.5 French Flexor.RTM. sheath may be approximately
380 degrees Fahrenheit for about five minutes, while the baking
parameters for a 4 French Flexor.RTM. sheath may be approximately
380 degrees Fahrenheit for about six minutes.
[0140] In addition to the outer sheath 50, the middle section
delivery device 14 further comprises an inner compression member
41. The delivery device 14 (and, thus, the outer sheath 50 and
inner compression member 41) may be constructed to have any
diameter and length required to fulfill its intended purposes.
[0141] The outer sheath 50, for instance, may be available in a
variety of lengths, outer diameters, and inner diameters. In one
embodiment, the outer sheath 50 may have a substantially uniform
outer diameter in the range from approximately 2 French to
approximately 7 French, and in one embodiment the diameter is from
approximately 4 French to approximately 5 French in diameter.
Otherwise stated, the outer sheath 50 may range from about 0.010
inches to about 0.090 inches in diameter, and in one embodiment the
diameter is approximately 0.050 inches. Likewise, the passageway 59
may be available in a variety of diameters. In one embodiment, the
inner diameter ranges from about 0.032 inches to about 0.040
inches, and in a preferred embodiment the passageway 59 is
approximately 0.032 inches. The diameter may be more or less than
these examples, however, depending on the intended vessel
passageway for the device. For instance, a larger vessel passageway
(e.g., greater expandable inner diameter) may tolerate a bigger
device with an outer sheath 50 having a correspondingly greater
diameter. Conversely, a narrower vessel passageway may require a
thinner outer sheath 50. Likewise, the overall length may vary. In
one embodiment, the outer sheath 50 will have a length from about
50.0 cm (or about 19.685 inches) to about 125.0 cm (or about 49.213
inches), and more particularly between about 70.0 cm (or about
27.559 inches) and about 105.0 cm (or about 41.339 inches), and in
yet another embodiment the length is approximately 100.0 cm (or
about 39.370 inches).
[0142] The inner compression member 41 comprises an elongated
pusher bar, stiffening member, or stiff polymer that helps to
"push" the stent by pushing the stent carrying inner guide channel
member at or near the distal portion 13 in order to counter the
urge for the stent or stent carrying member to move as a result of
an outer sheath or outer guide channel member being pulled over the
stent; thereby "pushing" holds the stent in place at the desired
deployment site within the patient's body. The inner compression
member 41 "pushes" the stent by helping to prevent or minimize the
inner guide channel member from prolapsing, recoiling, kinking,
buckling, or moving; thereby keeping the inner guide channel
member's stent platform on which the stent is disposed (discussed
later) substantially stationary, for the most part, relative to the
proximal retraction of the distal outer guide channel member
(discussed below) that exposes and, thus, deploys the stent. The
phrase "at or near" as used herein to describe an embodiment of the
invention includes a location that is at, within, or a short
distance such as about 0.1 cm to about 15.0 cm, although other
ranges may apply, for instance from about 0.5 cm to about 10.0
cm.
[0143] The overall length of the inner compression member 41 may
vary, as desired. In one embodiment the inner compression member 41
has a length from about 50.0 cm to about 175.0 cm, and more
particularly between about 75.0 cm and 150.0 cm, and in one
embodiment the length is approximately 125.0 cm to about 140.0 cm.
A portion of the inner compression member 41 (e.g., the proximal
end 40 and/or middle section 40') may be contained within the
handle 30 and the stylet 20, as explained above (FIG. 2).
[0144] Likewise, the diameter or width of the inner compression
member 41 may vary. In one embodiment, the inner compression member
41 has a diameter or width ranging from about 0.010 inches to about
0.030 inches, by way of example only and not by way of limitation.
In one embodiment, the inner compression member 41 has a diameter
or width that is approximately 0.016 inches. The diameter or width
may be more or less than these illustrative ranges. For example, a
deeper target site within a patient may require a thicker inner
compression member 41 for greater push-ability, but may tolerate
lesser flexibility. In addition, the material that the inner
compression member 41 comprises determines whether a smaller and
more flexible inner compression member 41 will give suitable
flexibility, and also determines whether a wider inner compression
member 41 may have the flexibility of a thinner inner compression
member 41 made of different material. Furthermore, the inner
compression member 41 may have a curved transverse cross-section,
such as, for example, a circular cross-section, or it may have a
polygonal cross-section, such as, for example, a rectangular
cross-section. Alternatively, the transverse cross-section of the
inner compression member may include both curved and straight
portions. According to one embodiment, the inner compression member
41 may have a nonuniform diameter or width along its length. These
various diameters, widths, and cross-sections may occur at the
inner compression member proximal end 40, the inner compression
member middle section 40', and/or the inner compression member
distal mating end portion 48. It should be understood that the
diameter, width, and/or cross-section of the inner compression
member 41 may taper.
[0145] Also, an inner compression member 41 may have an outer
surface comprising a lubricious PTFE material and/or an inner
surface 44 of the outer sheath 50 may comprise a lubricious PTFE
material against the inner compression member 41, in order to allow
easy retraction of the outer sheath 50, which is in communication
with a distal outer guide channel member to deploy a self-expanding
stent, as will be explained later.
[0146] Generally, the inner compression member 41 and outer sheath
50 may optionally be approximately the same in length, and the
axial length of coil 43 will be less than the length of the inner
compression member and outer sheath. In one embodiment, however,
the inner compression member 41 comprises a proximal end 40 that
extends proximal relative to the outer sheath. In yet another
embodiment, the inner compression member extends to a position that
is distal the outer sheath. In still another embodiment, the inner
compression member 41 stops short of extending all the way to the
distal tip of the delivery system 10, and may stop generally from
10 to 40 cm short of the distal tip of the delivery system 10, and
in one embodiment it stops approximately 20 to 25 cm short of the
distal tip of the delivery system 10, where the distal end portion
of the inner compression member 41 is operatively coupled to a
proximal portion of an inner guide channel member.
[0147] As an alternative to a Flexor.RTM. sheath discussed above,
the outer sheath 50 may have a construction comprising multifilar
material, round wire, cable tubing, spiral cut cannula, cable
tubing connected to spiral cut cannula, round wire braid, flat
braid, and any equivalents thereto and/or combinations thereof.
FIGS. 4A through 4G are schematic views of alternative embodiments
of an outer sheath 50 for use as the middle section delivery device
14, with the delivery system's proximal and distal portions 12, 13,
respectively, of the device being removed for clarity.
[0148] In particular, FIGS. 4A and 4B illustrate alternative
embodiments of an outer sheath 50 comprising a construction of
multifilar material. The multifilar material is illustrated as
tubular but could also be other shapes, such as plastic or metal
cables or wires that are flat, rectangular, and the like. Such
multifilar material or tubing may be obtained, for example, from
Asahi-Intec USA, Inc. (Newport Beach, Calif.). Materials and
methods of manufacturing a suitable multifilar tubing are described
in Published U.S. Patent Application 2004/0116833 (Koto et al.)
having an application Ser. No. 10/611,664 and entitled,
"Wire-Stranded Hollow Coil Body, A Medical Equipment Made Therefrom
and a Method of Making the Same," the contents of which are
incorporated herein by reference. Use of multifilar tubing in a
vascular catheter device, for instance, is described in U.S. Pat.
No. 6,589,227 (Sonderskov Klint, et al.; Assigned to Cook
Incorporated of Bloomington, Ind. and William Cook Europe of
Bjaeverskov, Denmark), which is also incorporated by reference.
[0149] The middle section delivery device 14 of FIGS. 3 and 4A-4G
may taper distally to enhance flexibility in several ways. For
example, flexibility increases by decreasing the outer diameter of
the outer sheath 50. The portion of the outer sheath 50 having a
smaller diameter is more flexible than the portion having a larger
diameter. Such tapering also decreases the thickness of the outer
sheath wall. A grinding process or other suitable process is used
to reduce the outer diameter, as shown in FIG. 4B. Alternatively,
tapering may be used within the internal diameter of the outer
sheath 50, enhancing flexibility by decreasing wall thickness
without altering the outer diameter. A milling process or other
suitable process is used to reduce the wall thickness without
altering the outer diameter. The steepness and location of the
tapering is determined by the desired application of the delivery
system 10. For example, use of the device in coronary arteries will
typically benefit from a smaller outer diameter, compared to use of
the device in a bile duct, both for gross size and flexibility.
[0150] FIGS. 4C through 4E show alternative constructions of the
outer sheath 50. While the multifilar materials of FIGS. 4A-4B are
side-by-side and extend approximately longitudinally, FIG. 4C shows
an outer sheath 50 that is a wrapped round coil of an approximate
perpendicular pitch relative to the longitudinal axis outer sheath
50. FIG. 4D shows an outer sheath 50 that is a wrapped cable tubing
or spiral cut cannula wherein the coil, compared to FIG. 4C, has a
more acute pitch relative to the longitudinal axis of the outer
sheath 50. FIG. 4E shows that various constructions can be combined
for an outer sheath 50, such as one section constructed of the
wrapped round coil of FIG. 4C and one section constructed of the
cable tubing/spiral cut cannula of FIG. 4D. Other embodiments of an
outer sheath 50 comprise a plurality of round wire braids (e.g.,
strands) of suitable material weaved as in FIG. 4F or a flat
braided construction as in as in FIG. 4G. The term "plurality," as
used herein and throughout to describe embodiments of the
invention, means "two or more."
[0151] According to the embodiments of the outer sheath 50 shown in
FIGS. 3, 4A, 4B, 4C, 4D, 4E, 4F, and/or 4G may comprise a drug
eluting coating. This coating may comprise a therapeutic agent.
Types of agents may be active, such as a medicine utilized in the
medical procedure to, for example, assist with the healing process,
assist with reducing bacterial count, and otherwise assist with
delivering medication. Other types of agents may comprise inactive
coatings, such as AQ.RTM. hydrophilic. Still other agents may
comprise biodegradable polymers that are active, inactive, or
polymeric.
Operatively Coupling the Middle Section Delivery Device 14 and the
Distal Portion 13
[0152] Against the foregoing description of embodiments of the
proximal portion 12 and middle section delivery device 14 and
before discussing embodiments of the distal portion 13 of the
delivery system, the invention further comprises associating the
distal portion 13 and the middle section delivery device 14. These
ways of operatively coupling the middle section delivery device 14
and distal portion 13 allow the outer guide channel member 80 of
the distal portion 13 to move relative to the inner guide channel
member 70 of the distal portion 13. In particular, the outer sheath
50 of the middle section delivery device 14 may be operatively
coupled with the outer guide channel member 80 of the distal
portion 13. Also, the inner compression member 41 of the middle
section delivery device 14 may be operatively coupled with the
inner guide channel member 70 of the distal portion 13. Therefore,
the ways of constructing or joining the middle section delivery
device 14 and distal portion 13 as described below are merely
illustrations of non-limiting embodiments only.
[0153] In one embodiment, outer guide channel member 80 of the
distal portion 13 and the outer sheath 50 of the middle section
delivery device 14 may be constructed as comprising an integral
unit. In other words, the same outer body sheath 50 construction
shown and described in connection with FIGS. 4A-4G may comprise the
outer sheath 50 of the middle section delivery device 14 as
labeled, but it may also comprise an integral construction with the
outer guide channel member of the distal portion.
[0154] FIG. 5 shows an alternative embodiment of an integral
construction of the outer sheath 50 of the middle section delivery
device and the outer guide channel member 80. In one embodiment,
the outer sheath 50 and the outer guide channel member 80 comprise
a Flexor.RTM. sheath or equivalent device shown in FIG. 3 and
described above. While FIG. 5 shows an outer sheath and outer guide
channel member 50, 80, respectively, having a coil 43, however,
these outer bodies could use any other construction shown in FIGS.
4A-4G or combination thereof.
[0155] Moreover, where coil, multifilar material, weave, or braid
(as described in the context of FIGS. 4A through 4G) is used in
combination or individually, each may be continuous along the
length of the outer sheath 50 of the middle section delivery device
14 and outer guide channel 80 of the distal portion 13 in one
embodiment. In an alternative embodiment, a plurality of coils,
multifilar materials, weaves, or braids may be joined end-to-end by
a lap joint, brace, or other suitable means along the length of the
outer sheath 50 of the middle section delivery device 14 and outer
guide channel 80 of the distal portion 13. In a further alternative
embodiment, a plurality of coil, multifilar material, weave, or
braid may comprise a plurality of segments as where each segment is
joined end-to-end by a lap joint, brace, or other suitable means
along the length of the outer sheath 50 of the middle section
delivery device 14 and outer guide channel 80 of the distal portion
13.
[0156] Another embodiment may be used for constructing or joining
the middle section delivery device 14 and distal portion 13 in a
way that permits the outer guide channel member 80 of the distal
portion 13 to move relative to the inner guide channel member 70 of
the distal portion 13. In this embodiment, the outer sheath 50 of
the middle section delivery device 14 and the outer guide channel
member 80 of the distal portion 13 comprise a plurality of units.
Each unit may comprise the construction shown and described above
in connection with the discussion relating to FIGS. 4A through 4G
and/or FIG. 5. Moreover, the plurality of units, such as the distal
portion 13 and the middle section delivery device 14, may be
assembled or joined together in various ways described next.
[0157] In one assembly, the distal portion 13 and the middle
section delivery device 14 may be put together by any suitable
connector. By way of example, the middle section delivery device 14
and distal portion 13 may be put together with a lap joint or a
brace.
[0158] FIG. 5A provides a longitudinally sectioned schematic side
view, broken away, of a brace section 240 for use in associating
the middle section delivery device and a distal portion of a
medical device according to the invention. FIG. 5B shows a cross
sectional view of FIG. 5A taken along the lines 5B-5B.
[0159] According to FIGS. 5A and 5B, the brace section 240
comprises a puller 54 that can be used to connect or fasten two
structures. For instance, the puller 54 may be used to operatively
couple the middle section delivery device 14 and the distal portion
13. In general, the puller 54 represents any bridged reinforcement
piece of suitable material, such as stainless steel wire or other
alloy, with a proximal flattened end and a distal flattened end,
wherein the proximal flattened is placed between a Teflon inner
layer 242 and/or coil 243 and a nylon outer layer 244 of an outer
sheath 50 and wherein the distal flattened end is placed between a
Teflon inner layer 242 and/or coil 243 and a nylon outer layer 244
of an outer guide channel member. The puller 54 may be heat bonded
between the Teflon inner layer 242 and the nylon outer layer 244,
or it may be adhesively bonded to the Teflon inner layer 242 and
the nylon outer layer 244, or it may be welded, soldered, glued, or
lap jointed to the coil 243.
[0160] Also, the puller 54 may join a plurality of coils,
multifilar materials, weaves, or braids end-to-end. Furthermore,
the puller 54 may join a plurality of segments comprising a coil,
multifilar material, weave, or braid. Moreover, the puller 54, when
used with a "Flexor.RTM." sheath as an outer sheath 50 of a middle
section delivery device 14 as previously described, provides
additional strength anywhere support is needed to provide
structural integrity, such as when there is a gap between the
bridged components, or a reduced cross sectional area of a
component compromises that component's structural integrity.
[0161] FIGS. 5A and 5B show the brace section 240 comprising three
layers: an inner layer 242, a middle layer 243, and an outer layer
244. The inner layer 242 may comprise Teflon; the outer layer 244
may comprise nylon and/or PEBA; and the middle layer 243 may
comprise stainless steel circumferential coil. Heating the brace
section 240 to an appropriate temperature reduces the outer layer
inner surface 249 to a liquid state. Treating, mechanical or
chemical etching, sandblasting, or otherwise preparing the inner
layer outer surface 241 improves the bonding properties of the
inner layer outer surface 249. Consequently, the melted outer layer
inner surface 249 seeps through spaces in or between middle layer
coils 243 and bonds to both the inner layer outer surface 241 and
to the coils 243.
[0162] FIG. 9B shows that the brace section 240 may further
comprise one or more pullers 54. The pullers 54 may include, for
example, stainless steel flat wire. Optionally, a puller 54 may
overlap, weave, or braid with the middle layer coils 243. The
surface of the puller 54 may be treated, mechanical or chemical
etched, sandblasted, or otherwise prepared and the outer layer
inner surface 249 melted to bond the three layers 242, 243, 244 and
the puller 54 anywhere two structures need connecting or fastening,
or simply anywhere additional support is needed.
[0163] In one embodiment, the puller 54 is generally rectangular,
polygonal, or irregular in shape or cross section and is positioned
approximately parallel to a longitudinal axis 246 of the brace
section 240. Alternatively, the distal portion 13 and the middle
section delivery device 14 may be attached, adjoined, joined, or
combined by a brace section 240, wherein the puller 54 is a
mechanical connector selected from the group consisting of a wire,
inward protrusion, nuts and bolts, pins, clamp, pincher, hook,
fastener, joint, ring, sheath, ball and socket, full or partial
bearing, shaft, thread, cable, rod, bar, ball or hemispherical
ball, fulcrum, support, linkage, or other crimping, clutching,
gripping, joining, or holding mechanical holding materials, to name
a few illustrative examples of mechanical connectors for
operatively coupling the middle section delivery device 14 and the
distal portion 13 in accordance with an embodiment of the
invention. Other examples of a puller 54 include glue, adhesives,
resins, welding, soldering, brazing, adhesives, or chemical bonding
materials or combinations thereof. By way of further illustration,
the distal portion 13 and middle section delivery device 14 may be
attached by a puller 54 that is a stainless steel coil.
[0164] FIGS. 5C through 5K show the distal portion 13 and middle
section delivery device 14 are operatively coupled by a bridging
device 100 as in FIGS. 5C through 5K. For clarity, the distal
portion 13 and middle section delivery device 14 having a delivery
device 40 with an outer sheath 50 and inner compression member 41
are not shown in full in FIGS. 5C through 5K, and instead they are
only represented schematically as a truncated tubular distal
portion 13 and a truncated tubular middle section delivery device
14.
[0165] A bridging device 100 has a low profile and may vary in
length, thickness, and width. For example, the length may be from 1
cm to about 10 cm or more, and in one embodiment from about 2 cm to
about 6 cm, or it may correspond to the approximate length of the
self-expanding device in a compressed state or the approximate
length that the outer guide channel member may need to slide
relative to the inner guide channel member to deploy the
self-expanding device. Moreover, the low profile of the bridging
device 100--relative to the distal portion 13 or middle section
delivery device 14--facilitates the exiting of a wire guide from a
breech position opening 65 located at or near the rear, back, or
proximal part of the distal portion 13. The low profile and length
allow the physician to grab the exiting wire guide as needed. The
physician may desire to feed the exiting wire guide into another
instrument, into a passageway of the middle section, or through one
or more eyelets attached to maintain the wire guide the middle
section to substantially parallel with or side-by-side with the
middle section delivery device 14.
[0166] The bridging device 100 further comprises a link member 101'
joining the bridge to the distal portion 13 and a link member 101
joining the bridge to the middle section delivery device 14. The
link members 101, 101' may be any puller 54 described above for
assembling the middle section delivery device 14 and distal portion
13, where the puller 54 is a connector selected from the group
consisting of mechanical structures, chemical bonding materials
(resins, glue, adhesives, and the like), and welding (soldering,
brazing, and the like) materials or combinations. Certain
additional non-limiting examples of link members 101, 101' comprise
a nut, bolt, screw, thread, suture, cotter and pin, spring, full or
partial bearing, bearing surface, rivet, pin, shaft, thread, joint,
or other linkage or securing mechanism. Furthermore, a link member
101, 101' may join the bridging device 100 to an outer surface or
an inside surface of the middle section delivery device 14 or
distal portion 13.
[0167] The bridging device 100 may comprise a single span
construction or a plurality of spans. FIGS. 5C-5G show various
views of an embodiment of a bridging device 100 comprising a span
102 and link members 101, 101'. In alternative embodiments as shown
in FIGS. 5H-5K, the bridging device 100 comprises a first span 104
joined to the middle section delivery device 14 by a link member
101, and a second span 106 joined to the distal portion 13 by a
link member 101'. The first span 104 and second span 106 are joined
together by an articulation member 105.
[0168] The bridging device 100 may be made of any suitable material
used for the middle section delivery device 14 as described above
or used for the distal portion 13 as described below. The material
is resilient with sufficient column strength to be kink resistant.
Optionally, the bridging device 100 may be pliable, elastic,
twistable, and flexible. For illustration, only FIGS. 5F, 5I, and
5J are shown flexing, but the bridging device 100 of FIGS. 5C-5K
may all be made flexible (if desired). FIG. 5F shows the embodiment
flexing. FIG. 51 shows the embodiment with both first and second
spans 104, 106, respectively, flexing torsionally. FIG. 5J shows
the embodiment with the second span 106 flexing torsionally. The
flexibility of the bridging device 100 may be varied by the
materials used to construct the bridging device 100, depending on
the degree of flexibility desired.
[0169] Optionally, the span 102, first span 104, and second span
106 may articulate about link members 101, 101' as shown in FIGS.
5C-5G, and the articulation member 105 shown in FIGS. 5H-5K. When
articulation is desired, the link members 101, 101' and
articulation member 105 preferably comprise mechanical structures,
such as a nut, bolt, screw, thread, suture, cotter and pin, spring,
full or partial bearing, bearing surface, rivet, pin, shaft,
thread, joint, or other linkage or securing mechanism that allows
articulation. Furthermore, articulation may be controlled by
limiting the range of motion from a range within about 1 degree to
approximately 15 degrees.
[0170] Articulation, as used here, means that one or more of the
following pieces is moveable relative to one or more of the other
pieces: middle section delivery device 14, spans (102, 104, 106),
and distal portion 13. Articulation may include one or more degrees
of translational displacements and/or rotations. For instance, the
articulation may be axial, longitudinal, forward, backward,
orthogonal, lateral, transverse, rotational, pivotable, sloping
incline or decline, swinging, torsional, revolving, and other forms
of translation and/or rotation in an x, y, and/or z coordinate
system.
[0171] According to FIGS. 5L through 5O, a distal insert 220 and
proximal insert 230 may be used as an alternative embodiment of a
bridging device 100. The embodiments for FIGS. 5L through 5O may be
used for either or both the distal insert 220 and proximal insert
230, so alternative reference numerals are used, but are explained
separately below.
[0172] FIGS. 5L through 5O show examples of a distal insert 220
having an opening 283'' at a mating portion 222, an exit port 283'
at an interfacing portion 224, and the openings 283', 283''
defining a guide channel 281. Similarly, FIGS. 5L through 5O may
represent examples of a proximal insert 230 having an opening 233'
at a mating portion 232, an exit port 233 at an interfacing portion
234, and the openings 233', 233 defining a guide channel 231. The
inserts 220, 230 are generally tubular, and one embodiment is a
cannula.
[0173] FIG. 5L shows an example of an insert 220, 230 that has an
opening 283'', 233' at a flared mating portion 222, 232 for
securing to the outside of the outer sheath distal end and outer
guide channel member second end 58, 87, respectively. It should be
understood that the mating portions 222, 232 of the other FIGS. 5M
through 5O also may secure, however, either to the outer sheath
distal end or outer guide channel member second end 58, 87,
respectively. The inserts 220, 230 may comprise any of the
materials as previously described as making up the middle section
delivery device 14 or later described as making up the distal
portion 13. In one embodiment, the inserts 220, 230 are stainless
steel cannulas.
[0174] The lengths of the inserts 220, 230 may vary from about 10
to 40 mm. In an alternative embodiment, the lengths are
approximately 15 to 25 mm. In still another embodiment, the lengths
are approximately 20 mm. The diameters of the guide channel 281,
231 also may vary. In most cases, the diameter will range from
approximately 2 to 7 French, with a preferred embodiment from
approximately 4 to 5 French in diameter. The openings 283', 233 may
be at an angle between a range of zero to about 90 degrees relative
to an axis of the insert 220, 230, respectively.
[0175] FIGS. 5N and 5O, in addition to having an opening 283'',
233' at a mating portion 222, 232, and a port 283', 233 at an
interfacing portion 224, 234 defining a channel 281, 231, further
having perforations 208 and/or slots 209 intermediate the mating
portion 222, 232 and the interfacing portion 224, 234. The
perforations and slots 208, 209, respectively, which may be
laser-cut, machined, milled, or drilled. The slots 209 of FIG. 5O
increase the flexibility of the inserts 220, 230. In addition, both
the perforations and the slots 208, 209 optimize the bonding
retention properties for securing the inserts 220, 230 to the outer
member and outer sheath, respectively, especially where the mating
portions 222, 232 are dispose between an inner layer 44 and outer
layer 42 of the outer guide channel member or outer sheath 80, 50,
respectively. In other words, the materials that form the inner and
outer layers 44, 42 join during the welding process, thereby
securing the mating portions 222, 232 between the inner and outer
layers, as shown in FIGS. 5R and 5S.
[0176] FIG. 5P represents sectional side schematic views, broken
away, of an outer guide channel member 80 (discussed below) and an
outer sheath 50. The outer guide channel member 80 comprises a
second end portion 87 with an exit port 83 and a guide channel 81.
The outer sheath 50 comprises a distal end 58 with a distal opening
52 and having a passageway 59.
[0177] A distal insert 220 has an outer member mating portion 222
secured to an outer guide channel member 80, while a proximal
insert 230 has an outer sheath mating portion 232 bonded to the
outer sheath distal end 58. In one embodiment, the outer member
mating portion 222 of the distal insert may be secured to an inner
layer 44 within the outer member guide channel 81, while the outer
sheath mating portion 232 of the proximal insert 230 may be secured
to an inner layer 44 within the outer sheath passageway 59. In an
alternative embodiment, the mating portions 222, 232 of the distal
insert 220 and proximal insert 230 may be received by and secure to
the outer layer 42 of the outer guide channel member 80 and the
outer sheath 50, respectively.
[0178] As shown in FIG. 5Q, another embodiment comprises the mating
portions 22, 232 of the distal insert 220 and proximal insert 230
being disposed between an inner layer 44 and an outer layer 42 of
the outer guide channel member 80 and the outer sheath 50,
respectively, wherein the mating portion 232 is optionally located
distal to the outer sheath coil 43 and wherein the mating portions
222 is optionally located proximal to the coil 43 of the inner
guide channel member 80. Optionally, an inner layer 44 comprises
Teflon material and an outer layer 42 optionally comprises a nylon
and/or PEBA material. Also, the mating portions 222, 232 optionally
replace a middle layer, such as a coil 43, of the outer sheath
distal end 58 and outer guide channel member second end portion 87,
respectively. In one embodiment, the mating portions 222, 232 are
secured to the outer sheath distal end 58 (between the inner and
outer layers 44, 42, respectively) and outer member second end
portion 87 (between the inner and outer layers 44, 42,
respectively), respectively, by melt bonding during initial
construction of the outer sheath distal end 58 and outer member
second end portion 87. Alternatively, post construction of the
distal end 58 and the outer guide channel member second end portion
87, the mating portions 222, 232 may be secured between the inner
and outer layers 44, 42, respectively, of the outer sheath distal
end 58 and outer guide channel member second end portion 87,
respectively, by heat-bonding, for example.
[0179] FIG. 5Q further shows an interfacing portion 224 of the
distal insert 220 and an interfacing portion 234 of the proximal
insert 230. The insert interfacing ends 224, 234 are brought
together and operatively coupled by any suitable connection
selected from the group consisting of glue, adhesive, resin,
welding, fusing, soldering, brazing, wire, crimping, link member,
interlocking member, or other mechanical or chemical bonding
materials or combinations thereof. One example of welding includes
laser welding. In addition, the insert interfacing ends 224, 234
may be operatively coupled by a solid-state bond resulting from
heat-bonding, such as the melting and solidifying (fusing) of
material of the interfacing ends 224, 234, which allows the joining
of similar and dissimilar metals according to materials
science.
[0180] FIG. 5R shows a sectional side view, broken away, of a
device having mating portions 222, 232 of an insert 220, 230,
respectively, according to FIG. 5O secured to the second end
portion 87 of the outer guide channel member 80 or the distal end
58 of the outer sheath 50, respectively. The mating portions 222,
232 are disposed between an inner layer 44 and an outer layer 42 of
the outer guide channel member 80 and outer sheath 50,
respectively. A connector 209' is formed through the slot 209 via a
solid-state bond resulting from heat-bonding, such as the melting
and solidifying (fusing) of the material of the outer and inner
layers 42, 44.
[0181] FIG. 5S shows a sectional side view, broken away, of a
device having openings 283'', 233' at mating portions 222, 232 of a
distal insert and proximal insert 220, 230, respectively, according
to FIG. 5N secured to the second end portion 87 of the outer guide
channel member 80 or the distal end 58 of the outer sheath 50,
respectively. The mating portions 222, 232 are disposed between an
inner layer 44 and an outer layer 42 of the outer guide channel
member 80 and outer sheath 50, respectively. A connector 208' is
formed through the perforation 208 via a solid-state bond resulting
from heat-bonding, such as the melting and solidifying (fusing) of
the material of the outer and inner layers 42, 44.
[0182] FIG. 5T shows a section side view, broken away, of an
example of an insert 220, 230 according to an embodiment of FIG.
5L. The mating portion 222 is flared for securing around the second
end portion 87 of an outer guide channel member 80. Alternatively,
the flared mating portion 232 is configured to secure around distal
end 58 of the outer sheath 50. In both of these and like
embodiments, the mating portion 222, 232 may also secure around the
outer layer 42 or the inner layer 44 of the outer guide channel
member 80 or outer sheath 50.
[0183] Optionally, the inner compression member distal mating end
48 may be secured to a proximal insert 230 and an inner guide
channel member second end portion 77 may be secured to a distal
insert 220. The insert interfacing ends 224, 234 are brought
together and operatively coupled by any suitable connection
discussed above. Alternatively, the proximal insert 230 may be
omitted, and the distal insert interfacing end 224 may be
operatively coupled directly to the inner compression member distal
mating end 48 by glue, adhesive, resin, welding, fusing, soldering,
brazing, melt bonding, crimping, or other mechanical or chemical
bonding materials or combinations thereof.
System Distal Portion 13
[0184] Now turning to embodiments of a distal portion 13 of medical
device delivery systems according to the invention, FIGS. 6, 7, 8,
and 9 show the distal portion 13 to be a relatively tubular body.
Given the configuration of vessels, vessel passageways, a working
channel of an endoscope, or an external accessory channel device
used with an endoscope to be navigated, a mostly tubular distal end
with a distal tapered, rounded, chamfered, or arrowhead shape may
be better tolerated by the patient. Further, in certain
embodiments, the distal portion of the distal portion 13 may be
soft, rounded, and flexible so as to provide further protection for
and care to the patient.
[0185] FIG. 6 illustrates an embodiment of the distal end 13 of a
delivery system for the rapid insertion of self-expanding stents
(for example) comprising an inner guide channel member 70, an outer
guide channel member 80 axially slideable relative to the inner
guide channel member 70, a self-expanding deployment device
mounting region 90 (e.g., a stent mounting region), and a
transition region 60. As used in connection with describing
embodiments of the inner and outer guide channel members 70, 80,
respectively, the term "guide channel" is understood to be any
aperture, bore, cavity, chamber, channel, duct, flow passage,
lumen, opening, orifice, or passageway that facilitates the
conveyance, evacuation, flow, movement, passage, regulation, or
ventilation of fluids, gases, or a diagnostic, monitoring, scope,
catheter, other instrument, or more particularly a wire guide (FIG.
8) or another component of the distal end (e.g., an inner guide
channel member 70 relative to the outer member channel 81).
[0186] The distal end 13, according to the delivery system 10 and
shown in FIGS. 6, 7, 8, and 9, may be made of any suitable material
(natural, synthetic, plastic, rubber, metal, or combination
thereof) that is rigid, strong, and resilient, although it should
be understood that the material may also be pliable, elastic, and
flexible. By way of illustration only and not by way of limitation,
the distal end may comprise one or a combination of the following
materials: metals and alloys such as nickel-titanium alloy
("nitinol") or medical grade stainless steel, and/or plastic and
polymers such as polyether ether-ketone ("PEEK"),
polytetrafluoroethylene (PTFE), nylon and/or a polyether block
amide ("PEBA"), polyimide, polyurethane, cellulose acetate,
cellulose nitrate, silicone, polyethylene terephthalate ("PET"),
polyamide, polyester, polyorthoester, polyanhydride, polyether
sulfone, polycarbonate, polypropylene, high molecular weight
polyethylene, polytetrafluoroethylene, or mixtures or copolymers
thereof, polylactic acid, polyglycolic acid or copolymers thereof,
polycaprolactone, polyhydroxyalkanoate, polyhydroxy-butyrate
valerate, polyhydroxy-butyrate valerate, or another polymer or
suitable material. Where it will not contact the patient (e.g., it
is contained within a sheath, working channel of an endoscope, or
an external accessory channel device used with an endoscope), the
middle section delivery device 14 and distal end 13 do not need to
be biocompatible. In contrast, where there is the possibility of
patient contact, the material may need to be biocompatible or
capable of being made biocompatible, such as by coating, chemical
treatment, or the like.
[0187] The inner and outer guide channel members 70, 80,
respectively, may be made of any suitable material described above
for use with the distal end 13. In one embodiment, the inner guide
channel member 70 and the outer guide channel member 80 comprise
PEEK material, which has the advantage of softening under heat
before burning or degrading. PEEK tubing may be purchased from many
suppliers, such as Zeus, Inc. in Orangeburg, S.C. for instance.
[0188] Beginning with the inner guide channel member 70, a
description will follow relating to features common to embodiments
of a distal end 13 of a delivery system 10 for the rapid insertion
of "stents" according to the invention. The inner guide channel
member 70 is generally tubular and comprises a first end portion 78
and a second end portion 77 defining a wire guide channel 71
therebetween. Optionally, the inner guide channel member 70 is
configured to be slidably nested, fitted, secured, or otherwise
positioned within the outer guide channel member 80 such that at
least one of the inner guide channel member first or second end
portions 78, 77, respectively, is axially intermediate an outer
guide channel member first end portion 88 and an outer guide
channel member second end portion 87.
[0189] The first end portion 78 of the inner guide channel member
70 further comprises a wire guide entry port 72, and the second end
portion 77 has a wire guide exit port 73. The entry and exit ports
72, 73, respectively, define and are in communication via the wire
guide channel 71. A port, in describing an embodiment of an inner
guide channel member 70 and an outer guide channel member 80
according to the invention, includes any structure that functions
as an entry or exit aperture, cutout, gap, hole, opening, orifice,
passage, passageway, port, or portal. The inner guide channel
member entry port 72 is sized to receive a wire guide into the
inner member guide channel 71, and the inner guide channel member
70 is configured so that the wire guide may exit proximally out the
inner guide channel member exit port 73. Optionally, the exit port
73 is located at or near the transition region 60. In one
embodiment of the present invention, the inner guide channel member
70 is a cannula (or catheter) having an entry port 72 and an exit
port 73 as previously described and defining a guide channel 71
therebetween.
[0190] The inner guide channel member 70 further comprises an outer
self-expanding deployment device mounting region 90 (e.g., an outer
stent mounting region) positioned intermediate the inner guide
channel member entry and exit ports 72, 73, respectively. The
length of the inner guide channel member 70 of any of the
embodiments of the present invention may vary generally from about
10.0 to about 40.0 cm. In one alternative embodiment, the length of
the inner guide channel member 70 is approximately 15.0 to
approximately 25.0 cm. In another embodiment, the length of the
inner guide channel member 70 is approximately 20.0 cm. Also, the
length of the inner guide channel member 70 may depend on the
intended stent, and in another embodiment the length of the inner
guide channel member 70 is approximately 15.0 cm for an 8.0 cm
stent.
[0191] The inner guide channel member 70 further comprises inner
and outer diameters. In one embodiment, both diameters are
substantially uniform over the entire length of the inner guide
channel member 70. By way of example, an internal diameter 74 might
measure approximately 0.0205 inches at or near the inner guide
channel member proximal second end portion 77, at or near the inner
guide channel member distal first end portion 78, and intermediate
the first and second end portions 78, 77, respectively. Likewise,
an inner guide channel member 70 might have an outer diameter 75
that measures approximately 0.0430 inches. Thus, the outer diameter
75 might measure approximately 0.0430 inches at or near the inner
guide channel member proximal second end portion 77, at or near the
inner guide channel member distal first end portion 78, and
intermediate the first and second end portions 78, 77.
[0192] In an alternative embodiment to an inner guide channel
member 70 having a substantially uniform outer diameter 75 along
its length from about the second end portion 77 to about the first
end portion 78, the inner guide channel member may also comprise a
tapered outer diameter 76. In one embodiment, the inner guide
channel member tapers distally to a second outer diameter 76' at or
near the inner guide channel member first end portion 78 or
intermediate the inner guide channel member first and second end
portions 78, 77, respectively. The taper 76 has a decreased cross
section, diameter, width, height, area, volume, thickness, and/or
other configuration, shape, form, profile, structure, external
outline, and/or contour relative to the outer diameter 75. In other
words, the inner guide channel member second outer diameter 76' is
smaller in cross section, diameter, width, height, area, volume,
thickness, and/or other configuration, shape, form, profile,
structure, external outline, and/or contour than the outer diameter
75.
[0193] FIG. 6 further shows an optional atraumatic tip 170 coupled
to the inner guide channel member first end portion 78. Extending
distally from the inner guide channel member first end portion 78,
the atraumatic tip 170 is tapered, rounded, chamfered, or arrowhead
shape to be better tolerated by the patient. The atraumatic tip 170
comprises a distal first end portion 178 with a wire guide entry
port 172 and a proximal second end portion 177 with a wire guide
exit port 173, whereby the entry and exit ports define an
atraumatic tip guide channel 171. The ports 172, 173 and channel
171 are sized to slidably receive a wire guide.
[0194] The atraumatic tip second end portion 177, as shown in FIG.
4, may abut the outer guide channel member distal end portion 88
and, thereby, extend entirely distally beyond a distal opening 89
of the outer guide channel member first end portion 88. Optionally,
the outer guide channel member distal opening 89 is spaced from the
atraumatic tip 170 sufficient to allow delivery system to be
flushed with saline that exits the distal end to remove air in
order to help keep air out of the patient, as explained above. In
the alternative and as shown in FIG. 5, the atraumatic tip 170 may
be configured to have a second end portion 177 that is beveled such
that the atraumatic tip second end 172 is partially positioned
within the outer member guide channel 81 and partially proximal to
the outer guide channel member distal opening 89. The beveled
design of the atraumatic tip second end portion 177 forms a
proximal stop against the outer guide channel member distal opening
89 while permitting the atraumatic tip second end portion 177 to be
partially slidably nested, fitted, secured, or otherwise positioned
within the outer guide channel member first end portion 88 so that
the outer guide channel member first end portion 88 overlaps the
atraumatic tip 170 to form a suitable seal that substantially
occludes passage of a wire guide between the atraumatic tip 170 and
the distal opening 89 of the outer member first end portion 88
(FIG. 7). Furthermore, the atraumatic tip second end portion 177
comprises a stent distal restraint 93' as explained below.
[0195] In FIG. 6, the outer guide channel member 80 also is
generally tubular and comprises a first end portion 88 and a second
end portion 87. The outer guide channel member 80 further comprises
a wire guide entry port 82 proximal to the first end portion 88 and
a proximal wire guide exit port 83 located at or near the second
end portion 87. The entry and exit ports, 82, 83, respectively,
define a guide channel 81 of the outer guide channel member 80,
wherein the ports 82, 83 and channel 81 are sized to slidably
receive a wire guide. The entry port 82 is configured to receive a
wire guide into the outer member guide channel 81, and in one
embodiment, the entry port 82 is defined by the inner guide channel
member exit port 73. In that embodiment, the wire guide moves
proximally through the inner member guide channel 71 and egresses
from the inner guide channel member exit port 73, wherein the
proximal passage of the inner guide channel member exit port 73 is
designated as the outer guide channel member wire guide entry port
82. The outer guide channel member proximal wire guide exit port 83
is configured so that a wire guide may egress proximally out the
outer member exit port 83. In one embodiment, the outer guide
channel member distal opening 89 and exit port 83 define the guide
channel 81 therebetween.
[0196] In one embodiment, the Flexor.RTM. sheath, manufactured and
sold by Cook Incorporated of Bloomington, Ind., may be adapted for
use with the distal end 13 and/or the middle section delivery
device 14. Otherwise stated, the Flexor.RTM. sheath, as shown in
FIG. 3 and described above, may be provided for the distal end 13
and/or the middle section delivery device 14. For instance, the
distal end 13 may be constructed as comprising an integral
Flexor.RTM. sheath tube with the middle section delivery device 14.
Alternatively, a Flexor.RTM. tubing may be used for either the
middle section delivery device 14 or the distal end 13, or both.
Then, the separable middle section delivery device 14 and distal
end 13 may be attached, adjoined, joined, or combined as taught
herein above.
[0197] The Flexor.RTM. sheath has a PTFE inner lining 44 that
provides a slick, smooth surface for sliding the outer sheath 50
and/or the outer guide channel member 80 proximally. With regard to
the distal end 13, the outer guide channel member 80 slides
relative to the inner guide channel member 70, and a stent
constraining inner surface 92 of the outer guide channel member 80
would be the inner layer 44 described above, thereby resulting in
minimal friction to a stent 17 on the stent platform 91. The
slidable inner surface 92 of the Flexor.RTM. sheath exhibits a
second benefit of minimizing damage or misalignment to the stent.
Indeed, because self-expanding stents continuously exert an
expanding force against the inside surface 92 of the outer guide
channel member 80, any substantial friction or drag between the
stent and the inner surface 92 of the outer guide channel member 80
as the outer guide channel member 80 withdraws may damage the stent
or cause the stent to be deployed slightly off of the target
site.
[0198] The thin flat wire reinforcing coil 43 of the Flexor.RTM.
sheath provides the outer guide channel member 80 with the
necessary radial strength to constrain the stent over long periods
of storage time. In contrast, where the a stent constraining inner
surface 92 of an outer guide channel member 80 does not comprise
the Flexor.RTM. sheath inner layer 44 or equivalent, the stent over
time may tend to become imbedded in the inner surface 92 and, as a
result, interfere with retraction of the outer guide channel member
80 at the time of deployment. In an outer guide channel member 80
that comprises a Flexor.RTM. sheath, in addition to the inner layer
44 and the reinforcing coil 43, the outer guide channel member 80
has a Flexor.RTM. sheath outer layer 42. The outer layer 42
comprises nylon and/or PEBA to provide the necessary stiffness for
pushability, retraction, and control of the outer guide channel
member 80 to facilitate proper deployment of the constrained
self-expanding stent. Therefore, the Flexor.RTM. sheath is one
non-limiting example of an embodiment of an outer sheath 50 and/or
an outer guide channel member 80.
[0199] While FIG. 6 shows an outer guide channel member 80 having
the exit port 83 proximal to the entry port 82 in one embodiment of
the outer guide channel member 80, the relative axial distances
between the entry and exit ports 82, 83, respectively, vary when
the outer guide channel member 80 is in a non-deployed state versus
a deployed state, because the outer guide channel member 80 moves
axially relative to the inner guide channel member 70. Otherwise
stated, FIG. 6 shows an embodiment where the exit port 83 is
proximal to the entry port 82 in either a non-deployed stent
position or in a deployed stent position. In a non-deployed stent
position of another embodiment, however, the exit port 83 may be
substantially co-planar to or aligned with the entry port 82. In
the fully deployed stent position, the exit port 83 may likewise be
proximal, co-planar, or aligned with the entry port 82. Optionally,
the entry port 82 and exit port 83 are located at or near the
transition region 60 to be discussed below.
[0200] Furthermore, the outer guide channel member 80 has a stepped
84, 85 profile, whereby the outer guide channel member 80 comprises
a first outer diameter 84 intermediate the outer guide channel
member first and second end portions 88, 87, respectively, and a
second smaller outer diameter 85 located at or near the outer guide
channel member second end portion 87 in the vicinity of the
transition region 60 and the breech position opening 65. The
stepped 84, 85 profile includes an embodiment where the outer guide
channel member 80 transitions to the distal end portion 58 of the
outer sheath 50 of the middle section delivery device 14. In
describing embodiments of the invention, however, the stepped 84,
85 profile shall be discussed in reference to the outer guide
channel member 80 in particular, but it should be understood as
including a stepped 84, 85 profile in reference to the transition
region 60 of the distal end 13 relative to the middle section
delivery device 14 where the middle section delivery device 14 and
distal end 13 are formed from separate units such as, by way of
example only and not by way of limitation, separate "Flexor.RTM."
sheaths where one comprises a first outer diameter 84 and the other
comprises a second smaller outer diameter 85.
[0201] As shown in FIG. 6, the second smaller outer diameter 85 of
the outer guide channel member 80 is located proximal to the larger
first outer diameter 84 and, thereby, comprises a stepped 84, 85
profile. Having a second smaller outer diameter 85 reduces the
profile of the outer guide channel member 80 and/or the outer guide
channel member 80 transition to the middle section delivery device
14, which is advantageous in procedures involving narrow vessel
passageways, endoscope working channels, or accessory channels for
use with endoscopes. The difference in the first diameter 84 and
the second diameter 85 may vary. By way of illustration, the second
diameter 85 may be approximately one-fourth to approximately
nine-tenths that of the first diameter 84. In another embodiment,
the second diameter 85 may be about one-half that of the first
diameter 84. In another embodiment, the first diameter 84 is
roughly 5 French while the second diameter 85 is roughly 4
French.
[0202] In one embodiment of the stepped 84, 85 profile of the outer
guide channel member 80, the second smaller outer diameter 85 is
located at or near the outer guide channel member second end
portion 87. The second end portion 87 may decrease precipitously
from the first outer diameter 84 to the second smaller diameter 85.
In a precipitous step, the change from the diameters occurs over a
short length along the longitudinal axis of the distal end 13. In a
further example of a precipitous step, the plane formed by the exit
port 83 may be substantially perpendicular to the longitudinal axis
of the outer guide channel member 80. In an alternative embodiment,
the second end portion 87 may decrease gradually from the first
outer diameter 84 to the second smaller diameter 85. In a gradual
step, the change from the two diameters occurs over a length of
more than 1.0 millimeter ("mm") along the longitudinal axis of the
distal end 13 at or near the transition region 60 and breech
position opening 65, and in one instance this change occurs over a
length from about 1.0 mm to about 10.0 mm. In a further example of
a gradual step, the plane formed by the exit port 83 may be at an
angle other than 90 degrees relative to the longitudinal axis of
the distal end 13.
[0203] FIG. 6 also shows a breech position opening 65 located at or
near the second end portion 87 of the outer guide channel member 80
comprising the wire guide exit port 83. In other words, rather than
the exit port 83 being an aperture in a lateral sidewall of the
outer guide channel member 80 intermediate the first and second end
portions 88, 87, respectively, in a breech position opening 65
embodiment the exit port 83 is at the rear, back, or proximal part
of the distal end 13 at or near the outer member second end portion
87 and the stepped 84, 85 profile such that it opens in the
direction of the outer surface of the outer sheath 50.
[0204] The breech position opening 65 may be used for front-loading
and the more common procedure of back-loading a wire guide (or
catheter, for instance). In a back-loading procedure for a delivery
system having a breech position opening 65, the wire guide may pass
proximally through the guide channel 71 of the inner guide channel
member 70, proximally through the guide channel 81 of the outer
guide channel member 80, and leave the exit port 83 of the second
end portion 87 of the outer guide channel member 80 from a breech
position opening 65 in a rear, back, or proximal part of the distal
end 13. Conversely, in a front-loading procedure for a delivery
system having a breech position opening 65, the physician may feed
the wire guide distally into a breech position opening 65 at the
rear, back, or proximal part of the distal end 13 by entering the
exit port 83 of the second end portion 87 and the guide channel 81
of the outer guide channel member 80 and through the guide channel
71 of the inner guide channel member 70, where the wire guide may
exit from the wire guide entry port 72 of the inner guide channel
member 70 and/or wire guide entry port 172 of the atraumatic tip
170.
[0205] In a distal portion 13 having a breech position opening 65
that comprises an exit port 83 located at a breech position of the
transition region 60 according to the invention, the wire guide
does not need to make any sharp turns away from the longitudinal
axis of the guide channel 71 of the inner guide channel member 70
and/or the distal portion 13 generally that may result in kinking
of the wire guide. In one embodiment, the exit port 83 is spaced
proximally of the inner guide channel member second end portion 77
and is substantially (e.g., less than 30 degrees and preferably
less than 15 degrees) along the longitudinal axis of the inner
guide channel member 70 such that the longitudinal axis of the
inner guide channel member 70 intersects the exit port 83, runs
through the exit port 83, or the exit port 83 otherwise lies along
the plane of the longitudinal axis of the inner guide channel
member 70. In another embodiment, the exit port 83 is within the
plan form by the side walls of the outer guide channel member 80,
as opposed to a sideport that is within the sidewall of the outer
guide channel member 80, wherein the wire guide needs to may a
sharp turn away from the longitudinal axis of the guide channel 71.
In another embodiment, the breech position opening 65 comprises an
exit port 83 according to embodiments of the invention, as those
shown in FIGS. 6, 7, 8, and 9 (by way of example and not by way of
limitation) is located proximal to the inner guide channel member
second end portion 77 and may be transverse or angled relative to
the longitudinal axis of the tubular inner guide channel member 70
and/or the distal portion 13. In one embodiment, the wire guide
exit port 83 may be positioned at or near a breech position opening
65 of the distal portion 13, wherein the exit port 83 is located at
or near the rear, back, or proximal part of the outer guide channel
member 80 and/or second end portion 87; in other words, not
positioned exclusively on the side (e.g., outer circumferential
cylinder wall) or substantially a length of the side of the outer
guide channel member 80.
[0206] In FIG. 6, the breech position opening 65 comprises an exit
port 83 that is illustrated as being oblique, although other
configurations of the exit port may be utilized to aid the wire
guide in exiting the rear of the outer member. In one example, the
exit port 83 may form a plane substantially perpendicular to the
longitudinal axis of the outer guide channel member second end
portion 87. In another example, the plane formed by the exit port
83 may be at an angle other than 90 degrees relative to the
longitudinal axis of the distal end 13. Optionally, the oblique
exit port 83 of a breech position opening 65 has lateral walls 83a,
83b that act as guide rails to direct a wire guide proximally
toward the middle section delivery device 14 and to run along the
outside of the outer sheath 50.
[0207] The overall axial length of the exit port 83 of the breech
position opening 65 may vary. In one embodiment, the length is
approximately from about 1.0 mm to about 10.0 mm. Another
embodiment has a length of approximately 5.0 mm. The overall width
of the exit port 83 may also vary. In one example, the width of the
exit port is approximately 1 French. In yet another instance, the
width of the exit port 83 ranges from about 1 French to about 4
French. In another example, the width of the exit port 83 may be
the approximate difference between the first outer diameter 84 and
the second outer diameter 85 of the outer guide channel member 80.
In yet another embodiment, the exit port 83 comprises a diameter
defined as being substantially equal to the difference between the
outer guide channel member first outer diameter 84 and the outer
guide channel member second smaller outer diameter 85.
[0208] At the transition region 60, the exit port 73 of the inner
guide channel member 70 is in communication with the outer guide
channel member 80 wire guide entry port 82, while the second end
portion 77 is operatively coupled to the distal mating end 48 of
the inner guide channel member 70 as explained below. The length of
the transition region 60 may vary. For instance, the transition
region 60 may be approximately from about 0.5 cm to about 10.0 cm.
In another embodiment, the transition region 60 has the approximate
length of about 5.0 cm. Furthermore, the length of the transition
region 60 is variable: from a shorter axial length when the outer
guide channel member 80 is in a non-deployed axial position; to a
greater axial length when the outer guide channel member 80
retracts proximally to deploy the stent. Likewise, the overall
length of the transition region 60 varies in the embodiment where
the exit port 83 is distal to the entry port 82 when the outer
guide channel member 80 is in a non-deployed stent position,
compared to the initial length of the transition region 60 in an
embodiment where the exit port 83 is proximal to the entry port 82
when the outer guide channel member 80 is in a non-deployed stent
position.
[0209] In one use of the transition region 60 according to an
embodiment of the invention, the outer guide channel member entry
port 82 receives a wire guide from the inner guide channel member
exit port 73 and the wire guide thereby is received in the outer
member guide channel 81. At the transition region 60, the inner
member guide channel 71 and outer member guide channel 81 are
approximately aligned relatively coaxially in one embodiment.
Approximate alignment of the guide channels 71, 81 facilitates a
smooth transition of the wire guide. Smooth transition optimally
reduces any bending of the wire guide as the wire guide moves
proximally from the inner member guide channel 71 to the outer
member guide channel 81.
[0210] Several factors individually or collectively may further
ensure that the inner member guide channel 71 and outer member
guide channel 81 are approximately aligned relatively coaxially so
that the wire guide may find its way out the distal portion 13. The
breech position opening 65 is located in a longitudinally optimal
location at the rear, back rear, back, or proximal part of the
distal portion 13. Also, the breech position opening 65 is large
enough to provide an easy exit; if too large it compromises the
structural integrity of the outer guide channel member 80 and/or
the transition region 60, and a puller 54 as taught herein may be
needed. Furthermore, the inside shape of the breech position
opening 65 is conducive to receiving the wire guide and directing
it out, as with the [lateral walls 83a, 83b that act as guide rails
to direct a wire guide proximally toward the middle section
delivery device 14 and to run along the outside of the outer sheath
50, and/or with the overall axial length of the exit port 83 of the
breech position opening 65 from about 1.0 mm to about 10.0 mm and
alternatively approximately 5.0 mm, and/or the overall width of the
exit port 83 of approximately from about 1 French to about 4 French
or the difference in the first outer diameter 84 and the second
outer diameter 85. Furthermore, outer sheath 50 has a passageway
that is only large enough for the inner compression member 41 to
pass through but not large enough to provide a receptacle for the
wire guide as it is being fed through the distal portion 13.
[0211] Moreover, as the delivery system is being assembled, a
pseudo-wire guide may be threaded through the breech position
opening "backward" from normal. The pseudo-wire guide is then
threaded backward through the inner guide channel member 70. As the
outer guide channel member 80 and inner guide channel member 70 are
slid together longitudinally, the pseudo-wire guide ensures that
the inner guide channel member exit port 73 and the outer guide
channel member exit port 83 are rotationally aligned. Because the
outer guide channel member 80 is operatively coupled to the outer
sheath 50 and the inner guide channel member 70 is operatively to
the inner compression member 41, by connected the outer sheath
proximal end 57 and the inner compression member proximal end 40 at
the system proximal portion 12 as described above, this locks the
inner guide channel member exit port 73 and the outer guide channel
member exit port 83 into a properly aligned relationship. Then, the
pseudo-wire guide can be removed, or left to function as a shipping
fixture that is removed by the end user.
[0212] As shown in FIG. 6, the distal end 13 also comprises a
self-expanding deployment device mounting region 90. This mounting
region 90 may be used for implantable prosthesis such as expandable
(self-expanding, balloon expandable, or otherwise expanding) and
nonexpanding stents, prosthetic valve devices, and other
implantable articles for placement inside a patient's body (the
implantable prostheses being referred to individually and
collectively as "stents" without limiting the invention) and
therefore may be referred to as a stent mounting region to include
the foregoing implantable prostheses.
[0213] The stent mounting region 90 comprises a stent platform 91
on an outside surface of the inner guide channel member 70 located
at or near the inner guide channel member second end portion 78. In
describing embodiments of the invention, the platform 91 "at or
near" the inner guide channel member second end portion 78 includes
a region intermediate the inner guide channel member entry port 72
and the inner guide channel member exit port 73. The platform 91
may be any stent mounting surface, including but not limited to the
outside surface of the inner guide channel member 70, a recess, or
an indentation located at or near the first end portion 78 of the
inner guide channel member 70. In a non-deployed state, a
self-expanding stent for example (not shown) compresses against the
stent platform 91 and disposes around the outside of the inner
guide channel member 70.
[0214] The stent mounting region 90 controls the lateral movement
(e.g., transverse expansion away from the inner guide channel
member longitudinal axis) to avoid premature deployment of the
stent. In order to control the lateral movement of the stent, the
stent is sandwiched between the platform 91 on the inner surface of
the stent and the stent constraining inner surface 92 of the outer
guide channel member 80 to keep the stent in a compressed state.
Because the stent is bound from above by the inner surface 92 of
the outer guide channel member 80 and bound from below by the
platform 91 of the inner guide channel member 70, the stent
mounting region 90 maintains the stent in a substantially
compressed state and controls premature deployment of the
stent.
[0215] In addition to controlling a stent's lateral movement, the
stent mounting region 90 restrains the axial movement of a stent to
control the stent movement away from the target site. A proximal
restraint 93 controls proximal axial movement of the stent. In one
embodiment, the proximal restraint 93 is sized to be large enough
to make sufficient contact with the loaded proximal end of the
stent without making frictional contact with the inner surface 92
of the outer guide channel member 80. In addition to helping to
stop the stent's proximal movement in the non-deployed state, this
restraint 93 assists with "pushing" the stent out of the distal end
13 by helping to prevent the inner guide channel member 70 and/or
the stent disposed on the stent mounting region 90 from migrating
proximally when the outer guide channel member 80 retracts
proximally relative to the stationary inner guide channel member 70
in order to expose and deploy the stent. Optionally, the restraint
93 may be radiopaque so as to aid in stent positioning within the
vessel passageway at or near the target site within a patient. In
one embodiment, an optional distal restraint 93' is large enough to
make sufficient contact with the loaded distal end of the stent to
control axially distal movement of the stent. Similarly, in another
embodiment the proximal second end portion 177 of an optional
atraumatic tip 170 controls the stent's distal axial movement.
Indeed, because the medical device delivery system may be used for
deploying an implantable prosthesis that comprises balloon
expandable or non-expanding stents, prosthetic valve devices, and
other implantable articles at a selected location inside a
patient's body, the proximal restraint 93 and distal restraint 93'
control the axial distal movement of the implantable prosthesis.
Optionally, the distal restraint 93' and/or atraumatic tip 170 may
comprise radiopaque materials so as to aid in stent positioning
within the vessel passageway at or near the target site within a
patient.
[0216] FIG. 6 also illustrates that the inner compression member 41
and inner guide channel member second end portion 77 may be
operatively coupled by any suitable means. In one embodiment, a
melt bond 47 (described below) operatively couples an inner
compression member distal mating end 48 ("mating end 48") and the
second end portion 77 of the inner guide channel member 70. A melt
bond 47 provides surface-to-surface contact between an outer
engaging surface 48' of the mating end 48 and the inner guide
channel second end portion 77, thereby forming a more solid
connection between the inner compression member 41 and the inner
guide channel member 70.
[0217] In one embodiment, the inner compression member outer
engaging surface 48' may form a melt bond 47 to an inner surface
101 of the inner guide channel member second end portion 77.
Alternatively, the inner compression member outer engaging surface
48' may form a melt bond 47 to the outer surface 102 of the inner
guide channel second end portion 77. In yet another embodiment, the
distal mating end 48 of a solid inner compression member 41 as
shown in FIG. 6 is implanted 49 between (and/or melt bonded 47
between) inner and outer surfaces 101, 102, respectively, of the
inner guide channel member second end portion 77. In still another
embodiment, an insert body operatively couples the inner
compression member 41 and the second end inner guide channel member
70.
[0218] As used to describe an embodiment of the invention, melt
bonding 47 (for shorthand purposes in describing embodiments
according to the invention, melt bonding 47 includes implanting 49)
comprises any suitable means for melting, liquefying, making
semi-molten, making molten, softening, making tacky, fusing, or
making malleable, pliant, supple, moldable, ductile, or otherwise
penetrable by another component or fused to melt bonding material
comprising the other element. For instance, melt bonding 47
involves bringing two components together at an interface, wherein
one (or preferably both) of the component interfaces are in the
melted state. Strictly speaking, true melt bonding 47 requires that
both of the components be melted at the interface and that they may
be sufficiently chemically and physically compatible such that they
fuse together upon cooling.
[0219] The melt bonding materials comprising the two components may
be the same or substantially same materials. In the alternative,
the melt bonding materials may be different, so long as they have
substantially similar melting points at standard atmospheric
pressure such that the materials soften (or liquefy) under heat and
thereby fuse together in a solid state melt bond 47 joining the
first and second melt bonding materials of the components. If the
materials had melting points that were too different, then one
material may degrade or burn and the like before the second
material begins to melt.
[0220] Melt bonding 47 may be single layer interface whereby one
component interface/surface mates to a second component
interface/surface, or may be multi-layer interface whereby one
component is implanted 49 into a second component and then
surrounded by the second component. The chemical compatibility can
best be expressed in terms of having similar values for surface
energy and/or solubility parameter. In simple terms, similar
materials tend to have a mutual affinity and a greater propensity
to adhere to one another than do dissimilar materials. Melt bonding
includes bonding whereby one component is melted while the other
component is at or above its melting point.
[0221] Melt bonding materials may have different "melt bonding"
temperatures at which they soften and become almost tacky without
substantial degradation. Melt bonding materials are available from
vendors, including Zeus, Inc. in Orangeburg, S.C. for instance;
Cobalt Polymers in Cloverdale, Calif.; and under the trade name of
Pebax.RTM. PEBA from the Arkema Group. The melt bonding materials
may include one or a combination of a class of suitable materials
comprising nylon, nylon natural tubing, polyether block amide,
polyetheretherketone, thermoplastic,
acrylonitrile-butadiene-styrene copolymer, polypropylene,
polyamide, ionomer, polycarbonate, polyphenylene oxide,
polyphenylene sulphide, acrylic, liquid crystal polymer,
polyolefin, polyethylene acrylate acid, polyvinylidene fluoride,
polyvinyl, and polyvinyl chloride.
[0222] In one embodiment, PEEK material is used for the melt
bonding material. PEEK melts at about 633.degree. F., so the
material may be heated from about 628.degree. F. to about
638.degree. F. For instance, a radiofrequency loop heater may be
used for heating the melt bonding materials. Such a machine is
available from Magnaforce, Incorporated and sold under the name and
model Heatstation 1500. Another such machine is available from
Cath-Tip, Inc. and is sold under the model and name Cath-Tip II.
There is a rise dwell and cool down time for the process. The total
rise time is approximately 20 seconds and dwell time is
approximately 10 seconds. During the dwell time the temperature is
approximately 600.degree. F. In one embodiment where nylon or PEBA
are used, heating is at about 400.degree. F., with dwell time of
about 10 seconds.
[0223] FIGS. 6A and 6B present a schematic representation of a
cross section 105 of components before and after melt bonding
according to one embodiment of the invention. The cross section 105
of FIG. 6A, for example, represents an inner component 106, a
middle component 107, and an outer component 108. While all
components are shown having interfaces in abutting physical
contact, they need only be close enough to form a melt bond
therebetween. Indeed, as previously explained in connection with
the Flexor.RTM. sheath's outer layer 42 and inner layer 44, there
may even be a middle layer comprising a coil 43 having spacings 43'
through which the melt bonding material of the outer layer 42 may
move to be into contact with the inner layer 44.
[0224] In the example represented in FIG. 6A, the middle and outer
components 107, 108, respectively, are intended to be melt bonded.
The middle component 107 comprises a first melt bonding material
109 while the outer component 108 comprises a second melt bonding
material 109', which may be the same material or may be separate
materials that have similar melting points at atmospheric
pressure.
[0225] FIG. 6B shows some of the first melt bonding material 109 of
the middle component 107 moving into some of the second melt
bonding material 109' of the outer component 108. Likewise, some of
the second melt bonding material 109' of the outer component 108
moves into some of the first melt bonding material 109 of the
middle component 107. It should be noted that both of the first and
second materials 109, 109' need not move into the other. Rather,
the first and second materials 109, 109' need only bond at an
interface, with or without mixing and the like. By way of example,
the Flexor.RTM. sheath's outer layer 42 may melt to the middle
layer coil 43 (which has not melted) and bond to the outer surface
of the inner layer 44 with or without the outer surface of the
inner layer 44 melting into the outer layer 42.
[0226] FIG. 6B further shows that the first and second melt bonding
materials 109, 109', respectively, of the middle component 107 and
the outer component 108 or other components that have been melt
bonded, upon cooling to solid state will form a melt bond 47
operatively coupling the components and/or the melt bonding
materials that comprise the components. This results in additional
strength and helps to form a more solid connection to the melt
bonded components, because a solid-state bond results from using a
suitable form of heat for melting and solidifying (e.g., fusing
and/or cross-linking bonds formed at the melt bonded material
interfaces).
[0227] FIG. 7 illustrates a schematic view showing an alternative
embodiment of a distal portion 13 of a delivery system for the
rapid insertion of stents comprising an inner guide channel member
70, an outer guide channel member 80 axially slideable relative to
the inner guide channel member 70, a deployment device mounting
region 90 (e.g., a stent mounting region), and a transition region
60. Like elements from the previous drawings, embodiments, and
description from above are labeled the same. In this embodiment,
the inner compression member 41 optionally comprises a passageway
45 (e.g., hollow, having a lumen) that facilitates the conveyance,
ventilation, flow, movement, blockage, evacuation, or regulation of
medication and/or fluids or accommodates the insertion of a
diagnostic, monitoring, scope, or other instrument.
[0228] The tubular inner compression member 41 may have a uniform
inside diameter ranging from about 0.0527 to about 0.132 inches.
The wall thickness of the tubular inner compression member 41 is
approximately 0.0015 inch. These dimensions are illustrative only,
and the inner diameter and wall thickness may be constructed to be
of any size necessary to accomplish the purposes for which the
delivery system is to be employed (i.e., limited by the vessel
passageway or working channel in which the device is to be
used).
[0229] In addition, this inner compression member 41 has an
optional distal one-way valve 61. Thus, the valve 61 may serve a
dual function. First, a one-way valve is relatively resistant to
contamination from bodily fluids entering the inner compression
member passageway 45. Second, it allows the movement of medication
and/or fluids to exit distally the inner compression member 41
passageway 45 at or near the transition region 60 and may direct
medication and/or fluids into the inner member guide channel 71
and/or the outer member guide channel 81.
[0230] Indeed, the inner compression member passageway 45 may
facilitate using the medical device delivery system for deploying
an implantable prosthesis that comprise balloon expandable stents,
prosthetic valve devices, and other implantable articles
(individually and collectively, "stent") at a selected location
inside a patient's body. The stent is disposed at the deployment
device mounting region 90 intermediate the proximal restraint 93
and distal restraint 93' to control the axial distal movement of
the implantable prosthesis.
[0231] In one embodiment for using the delivery system with a
balloon expandable implantable prosthesis, the inner compression
member distal mating end portion engaging surface 48' operatively
couples to the inner guide channel member outer surface 102 (or is
welded to an outer surface of a metal cannula that has the inner
guide channel member second end portion 77 glued within the cannula
lumen), and an inflation member (e.g., a balloon) extends distally
from the inner compression member distal mating end portion and is
disposed over the proximal restraint 93 and distally about the
platform 91 of the stent mounting region 90 such that the balloon
is located under the stent. The stent is positioned within the
vessel passageway at or near the target site within a patient,
wherein the outer sheath 50 and outer guide channel member 80 is
axially slideable relative to the inner compression member 41 and
inner guide channel member 70 upon corresponding axial slideable
movement of the handle 30, thereby exposing and, ultimately,
deploying the stent from the stent mounting region 90. The stylet
20 may be adapted to receive a syringe for allowing inflation
fluid, such as saline, to travel from and through the proximal end
40 of the inner compression member 41 and out the valve 61 at the
distal end portion 48 in order to fill the inflation chamber of the
balloon. Therefore, balloon expands under the stent and, as a
result, the stent expands radially to plastically deform the stent
into a substantially permanent expanded condition. The physician
then deflates the balloon and removes the inner guide channel
member 70 and remainder of the delivery system from the patient's
body. This description of using the delivery system for balloon
expandable implantable prosthesis is given by way of example and
not by way of limitation. Alternatively, a tubular inflation fluid
carrying device is in the outer sheath passageway 59 and extends
from the system proximal portion 12 to the system distal portion 13
and operatively couples to an inflation member disposed under the
stent.
[0232] In one embodiment of the distal portion 13 of a delivery
system illustrated in FIG. 7, an internal joint 46 comprises a melt
bond 47 that operatively couples the inner guide channel member
distal mating end portion 48 and the second end portion 77 of the
inner guide channel member 70. For example, the inner compression
member outer engaging surface 48' may form a melt bond 47 to the
inner surface 101 (or alternatively to the outer surface 102) of
the inner guide channel member second end portion 77, as taught
above.
[0233] The embodiment shown in FIG. 7 also illustrates that the
exit ports 83 and 73 may have various configurations. First, these
exit ports curve, and second, compared to FIG. 4 they slope over a
longer overall axial length to aid the wire guide in exiting the
inner member and outer member, respectively. Furthermore, the exit
port 83 thereby has longer axial lateral walls 83a, 83b for acting
as guide rails to direct a wire guide proximally toward the middle
section 14 and to run along the outside of the outer sheath 50.
[0234] Moving to the atraumatic tip 170 as illustrated in FIG. 7,
this is a little less arrowhead-shaped compared to the atraumatic
tip 170 shown in FIG. 6. Instead, the atraumatic tip in FIG. 7 has
a second end portion 177 that comprises a right cylindrical tubular
configuration. Furthermore, the sides of the atraumatic tip second
end portion 177 are more uniformly parallel and do not form a
proximal stop against the outer guide channel member distal opening
89 as in a beveled embodiment of the atraumatic tip second end
portion 177 as illustrated in FIG. 6. The atraumatic tip second end
portion 177 optionally comprises a stent distal restraint 93' for
controlling distal axial movement of the implantable prosthesis
when the medical device delivery system is used for deploying
balloon expandable or non-expanding stents, prosthetic valve
devices, and other implantable articles at a selected location
inside a patient's body.
[0235] Turning now to FIG. 8, that figure shows a partially
sectioned distal portion 13 in accordance with an embodiment of the
device according to FIG. 7 with a wire guide 16 inserted therein.
In a back-loading procedure, the wire guide 16 enters the guide
channel 171 of the atraumatic tip 170 and travels proximally toward
the inner guide channel member 70. The wire guide 16 then enters
the inner member guide channel 71 and travels proximally toward the
outer guide channel member 80 via the entry port 82 and enters the
outer member guide channel 81 and out the exit port 83. The less
common front-loading procedure could be described as above but
conversely stated.
[0236] In FIG. 8, the inner and outer guide channels 71, 81,
respectively, are substantially aligned coaxially along an
approximate center longitudinal axis of the distal portion 13.
Because the channels 71, 81 are substantially aligned, the wire
guide 16 moves through the inner member guide channel 71 to the
outer member guide channel 81 and out the outer guide channel
member exit port 83 at or near the breech position opening 65 with
relatively little kinking, bending, buckling, or bowing. It should
be noted that for the ease of showing the wire guide 16, the wire
guide 16 proximal to the exit port 83 is shown slightly offset from
outer sheath 50, though the wire guide 16 may actually run along
the outside of the outer sheath 50 or in a groove (not shown) in
the outer sheath 50.
[0237] FIG. 9 illustrates a longitudinally sectioned side view
showing an alternative embodiment of a distal portion 13 of a
delivery system for the rapid insertion of stents comprising an
inner guide channel member 70, an outer guide channel member 80
axially slideable relative to the inner guide channel member 70, a
deployment device mounting region 90 (e.g., a stent mounting
region), and a transition region 60. Like elements from the
previous drawings, embodiments, and description from above are
labeled the same. This embodiment represents an alternative
embodiment of a joint 46 for operatively coupling the inner
compression member 41 and inner guide channel member 70 with a
cannula 95.
[0238] In one embodiment, the cannula 95 is a hollow, rigid tube,
cylinder, ring, cannula (with or without a trocar), or other
coupling device comprising metal such as medical grade stainless
steel or super-elastic alloys (e.g., nitinol) to name but a few
non-limiting examples. In one embodiment, the cannula 95 comprises
a generally right cylindrical configuration or is elliptical,
hyperbolic, parabolic, curved, polygonal, rectangular, or irregular
in shape or cross section. The cannula 95 is sized for receiving
the inner guide channel second end portion 77 and/or the inner
guide channel second end portion outer diameter 75. The outer
surface 102 of the inner guide channel second end portion 77 is
operatively coupled to an inner engaging surface of the securing
body 95 by glue, adhesives, resins, chemical bonding materials or
combinations thereof and the like (collectively and individually,
"glue"). By way of example only, the glue may be Loctite 4061
instant adhesive, formulated to polymerise rapidly in thin films
between two surfaces to form rigid thermoplastics. Loctite 4061
instant adhesive is a medical device adhesive particularly suitable
for a wide variety of substrates such as rubber, plastics, and
metals, ant it is available from the Loctite Corporation.
[0239] In addition to securing the outer surface 102 of the inner
guide channel member second end portion 77 to an inner engaging
surface of the cannula 95, the cannula 95 also operatively couples
the inner guide channel member distal mating end portion 48. An
outer engaging surface 48' of the mating end portion 48 is in an
abutting relationship (e.g., touching, in contact directly or by
intervening parts, or adjacent) to an outer engaging surface of the
cannula 95, and the mating end portion 48 and cannula 95 are
operatively coupled by any suitable means, including but not
limiting to welding, soldering, brazing, or fusing. Soldering and
brazing are used if a semi-permanent connection between the distal
mating end portion 48 and the cannula 95 is desired, because solder
or braze metals have a lower melting point than the metals that are
joined. Thus, when sufficient heat is applied to melt the solder or
braze metal, they form an alloy with the surfaces of the mating end
portion 48 and the cannula 95 and, upon solidification, thus form a
joint that can be unfastened during manufacturing (e.g., to redo in
the event of a poor connection) by reheating without destroying the
parts that have been joined. In contrast, welding involves melting
the outer engaging surface 48' of the mating end portion 48 and an
outer engaging surface of the cannula 95 at the interface, or
involves combining temperature and pressure so as to cause
localized coalescence. Consequently, in most instances higher
temperatures are involved than for soldering, and the union is
permanent.
[0240] Where the inner compression member distal mating end portion
48 and the cannula 95 are connected, an optional tube may be
disposed about the joint 46. The tubing has the advantage of
minimizing some of the sharp edges created by a welded, soldered,
or fused joint. In one embodiment, the tube is a melt bonding tube
disposed about and melt bonded to the joint 46. Whereas FIG. 9
shows the distal most tip of the distal mating end portion 48 flush
with (e.g., substantially co-planar) the distal end portion of the
cannula 95, it may alternatively be set back approximately 0.5 mm
proximally from the distal end portion of the cannula 95. The set
back arrangement allows solder, weld, or fusion to form a smooth
transition and fill the space between that distal end tip and the
cannula 95. This would also minimize the profile compared to
placing more of a circumferential solder, weld, or fusion about the
joint.
[0241] According to FIGS. 9, 9A, 9B, and 9C, the distal mating end
portion 48 comprises a contoured configuration 48'' that is
complementary to an outer engaging surface 95' of the cannula 95.
Thus, in an embodiment comprising a cannula 95 that is curved or
otherwise circular in cross-section, then FIG. 9A shows that the
contoured configuration 48'' is fluted so that the outer engaging
surface 48' is capable of being in an abutting relationship (e.g.,
touching, in contact directly or by intervening parts, or adjacent)
relative to a curved or circular outer engaging surface 95' of the
cannula 95. A fluted contoured configuration 48'' comprises any
curved, shoehorn shape, celery shape, semicircular shape, crescent
shape, wishbone shape, saddle shape, C-shaped, V-shaped, U-shaped,
or other arcuate configuration. In another embodiment, an outer
engaging surface 95' of the cannula 95 could have a flat portion,
and FIG. 9B shows that the contoured configuration 48'' is likewise
flat so that the outer engaging surface 48' is capable of being in
an abutting relationship (e.g., touching, in contact directly or by
intervening parts, or adjacent) relative to the flat portion of the
outer engaging surface of the cannula 95. Even when the outer
engaging surface 95' of the cannula 95 is curved or circular in
cross section, however, FIG. 9C shows that the inner compression
member contoured configuration 48'' could be flat, because the
soldering, brazing, or fusing may fill in the space between the
outer engaging surface 48' and a tangent that the flat
configuration 48'' forms to the curved portion of the outer surface
95' of the cannula 95. Similarly, if welding 96 is used, then the
flat configuration 48'' will form to a curved or circular outer
engaging surface 95' of the cannula 95.
[0242] In addition, the contoured configuration 48'' maintains low
profile, high-strength, and flexibility of the connection between
the inner compression member distal mating end portion 48 and the
cannula 95. The contoured configuration 48'' is in contrast to a
rounded inner compression member distal mating end portion 48,
which would have a greater diameter at the connection between the
inner compression member distal mating end portion 48 and the
cannula 95.
[0243] In order to create the contoured configuration 48'', the
inner compression member distal mating end portion 48 may be
formed, sheared, casted, or molded. By way of example only, forming
can be done both hot and cold (except for stamping, which is always
done cold) in order to modify the shape and/or physical properties
of the material comprising the inner compression member distal
mating end portion 48. Common forming processes include rolling the
distal mating end portion 48 (between one or two rollers),
stretching, forging, straight bending, and stamping.
[0244] FIGS. 10 and 11 illustrate an alternate embodiment of a
distal portion 13 of a delivery system for the rapid insertion of
self-expanding stents during deployment of a stent. In FIG. 8, the
distal portion 13 is in an un-deployed position, while FIG. 9
depicts the distal portion 13 in a deployed position after proximal
retraction of an outer guide channel member 80 relative to the
inner guide channel member 70. In other words, the wire guide 16
both enters the distal portion 13 and exits the distal portion 13
of the delivery system at a substantially straight path so as to
minimize kinking of the wire guide, and then runs proximally along
the outside surface of the outer sheath 50. The outer guide channel
member 80 has a stepped profile comprising a first outer diameter
and a proximal second smaller outer diameter in order to maintain a
low profile at the transition region, as has been previously
describe in detail in relation to FIGS. 6, 7, 8, and 9. Moreover, a
guide 51 helps to align the wire guide as it exits the distal
portion 13. For example, the guide 51 may comprise a U-shaped
recess or an eyelet for aligning and guiding the wire guide.
Furthermore, an optional groove 52 on the outside surface of the
outer sheath 50 helps support the wire guide as it runs alongside
the outside of the outer sheath.
[0245] FIGS. 12, 13A through 13C, and 14A through 14F show
embodiments (by way of illustration and not by way of limitation)
of several partial schematic cross sectional views of FIGS. 10 and
11. FIG. 12 is a cross sectional schematic view of the stent
mounting region 90 taken along lines 12-12 of FIG. 10. FIG. 12
shows a guide wire 16 along a longitudinal axis (in the plane of
the paper) of the tubular stent mounting region 90 and within the
inner guide channel member 70. A stent 17 surrounds the inner guide
channel member 70, and in turn an outer guide channel member 80
covers the stent 17.
[0246] FIGS. 13A through 13C are cross sectional schematic views
taken along lines 13-13 of FIGS. 10 and 11. FIG. 13A shows an inner
compression member 41, which comprises an elongated pusher bar,
stiffening member, or stiff polymer that helps to "push" the stent
out at or near the distal portion 13 by preventing prolapse,
recoil, kinking, or movement (collectively, "prolapse") of the
inner guide channel member 70 relative to the outer guide channel
member 80 during proximal retraction of the outer member to deploy
self-expanding stent. While the inner compression member 41 is
depicted at about 6 o'clock, that position is only illustrative,
and can be located elsewhere within the boundary defined by the
outer guide channel member 80. The inner compression member 41 may
also have other configurations. By way of illustration, those
configures include a winged-shaped inner compression member 41 as
in FIG. 13B, or a "D-shaped" inner compression member 41 as in FIG.
11C for bonding and for an increased lumen area for higher flow
with injecting fluids (the characteristics of which are described
below in more detail).
[0247] FIGS. 14A through 14F are alternate illustrative embodiments
of cross sectional schematic views taken along lines 14-14 of FIGS.
10 and 11. These figures show various embodiments of several
features, including additional embodiments of the inner compression
member 41, an optional guide 51, and various embodiments of the
guide channels 71, 81 of the inner and outer members 70, 80. These
figures and their corresponding features are discussed next,
starting with the inner compression member 41 embodiments.
[0248] By way of illustration and not by way of limitation, FIGS.
14A through 14F depict an inner compression member 41, such as a
pusher bar, of different configurations. In FIGS. 14A, 14B, and
14E, for instance, the inner compression member 41 is a pusher bar
represented as a rod-like structure having a generally circular
cross section. However, the inner compression member 41 may also
assume other configurations, such as a semicircular shape (FIG.
14C), an arcuate shape (FIG. 14D), a crescent shape (FIG. 14F), or
the winged-shape or "D-shaped" previously discussed in connection
with FIGS. 13B and 13C, respectively, to name a few examples of
alternate configurations. These configurations help to provide an
inner compression member 41 with increased column strength guarding
against prolapse and having a low profile.
[0249] More specifically, FIG. 14A depicts an optional guide 51,
which can take on numerous configurations so as to achieve the
function of aligning the wire guide as it exits proximally the
distal portion 13, such as a saddle or a shelf shape (FIG. 14A) or
a butterfly or dog bone shape (FIG. 14B) to name a few.
Additionally, it should be understood in FIG. 14A that the saddle
groove of the guide 51 could abut the inner compression member 41
(e.g., pusher bar) and allow limited passage of the wire guide
16.
[0250] Likewise, the guide channel 71 of the inner guide channel
member 70 and the guide channel 81 of the outer guide channel
member 80 may assume numerous configurations to ensure a low
profile at the distal end, and to guide the wire guide 16. These
configurations include but are not limited to spherical,
elliptical, crescent, saddle, slit, or wishbone shapes, such as by
way of illustration the co-axial channels 71, 81 of FIG. 14C, a
groove guide channel 71 leading to the interior lumen of channel 81
as shown in FIG. 14D, or the channels 71, 81 may be concentric
semi-circular channels as depicted in FIG. 14E. Additionally, the
diameters of channels 71, 81 need not be constant, and optionally
in certain embodiments may be tapered (reduced circumference).
[0251] FIG. 15 is an alternate illustrative embodiment of a cross
sectional schematic view taken along lines 15-15 of FIGS. 10 and 11
(absent the wire guide 16). This figure shows an inner compression
member 41 and an outer sheath 50. Furthermore, FIG. 15 illustrates
an optional groove 52 on the outside surface of the outer sheath 50
to help the wire guide run proximally alongside the outside of the
outer sheath.
[0252] FIG. 16 is an alternative embodiment of an outer guide
channel member 80 used in a delivery system for the rapid insertion
of self-expanding stents during deployment of a stent. The outer
guide channel member 80 is tubular and includes a wire guide entry
port 82 and a breech position opening 65 comprising a proximal wire
guide exit port 83, the entry and exit ports defining a guide
channel 81 of the outer guide channel member 80. The exit port 83
in this embodiment is slanted. The outer guide channel member 80
has a stepped 84, 85 profile comprising a first outer diameter 84
and a second smaller outer diameter 85 located proximal to the
larger first outer diameter 84. The second smaller outer diameter
85 offsets the added diameter of the wire guide as it leaves the
exit port 83 and runs proximally alongside the outside of the outer
sheath, thereby maintaining a negligible dimension to the profile,
which is a particular advantage in procedures involving narrow
vessel passageways.
[0253] FIG. 17 is an alternative embodiment of an inner guide
channel member 70 used in a delivery system for the rapid insertion
of self-expanding stents during deployment of a stent. The inner
guide channel member 70 in this embodiment is tubular and has a
distal arrowhead tip 70' that is rounded and chamfered to be better
tolerated by the patient. Formed from a suitable material
(discussed above), the distal tip 70' is soft, rounded, and
flexible so as to provide further safety to the patient. The inner
guide channel member 70 has a wire guide entry port 72 and a
proximal wire guide exit port 73 that define a guide channel 71.
The exit port 73 in this embodiment is transverse to an inner
compression member 41 and attached thereto by any suitable means,
such as welding, brazening, adhesives, wires, chemical
cross-linking, heat source, light source, radiofrequency, lasering,
or other energy source for attaching the inner guide channel member
70 to the inner compression member 41.
[0254] FIG. 18 shows a schematic sectional side view of an
alternative embodiment of a distal portion 13 of a delivery system
for the rapid insertion of self-expanding stents. This embodiment
further comprises a puller 54. Furthermore, this embodiment
comprises an inner guide channel member 70, an outer guide channel
member 80 axially slideable relative to the inner guide channel
member 70, and a stent mounting region 90 sandwiched between the
inner and outer guide channel members 70, 80, respectively.
Moreover, the outer member guide channels 71, 81 are substantially
aligned coaxially along an approximate center longitudinal axis.
Therefore, the wire guide 16 moves through the guide channel 71 to
the outer member guide channel 81 and out the outer member exit
port 83, and thereby egresses the breech position opening 65 (e.g.,
rear, back, or proximal part of the distal portion 13) with
relatively little kinking, bending, buckling, or bowing. The breech
position opening 65 is oversized to facilitate the wire guide 16
exiting the distal portion 13 with relatively little kinking,
bending, buckling, or bowing.
[0255] The puller 54 of the embodiment of the distal portion 13 of
FIG. 16 has a low profile relative to the first outer diameter 84
and a second smaller outer diameter 85 sufficient to provide a
stiffening element, a tension element, and an occlusion element.
Optionally, the puller 54 is sandwiched between an outer surface 47
of the inner compression member 41 and an inner surface 57 of the
outer sheath 50. Also, the puller 54 may be unattached but wedged
nearly immovably between the compression member outer surface 47
and the outer sheath inner surface 57, or it may be attached by
mechanical structures, chemical bonding materials, and welding
materials or combinations as described above in connection with the
bridge 100. Optionally, the puller 54 is tubular and surrounds a
portion of the inner compression member 41, in which case the
puller 54 may have a plurality of thicknesses sufficient to lift
the inner compression member 41 and occlude the wire guide 16 from
entering a passageway 45 of the inner compression member 41 or a
gap 55 (as described below). Furthermore, the puller 54 may be a
cutout ring, with the cutout located on the portion of the puller
closest to the exit port 83. In yet another embodiment, the puller
54 comprises a protuberance that lifts the inner compression member
41 and thereby occludes the wire guide 16 from the inner
compression member 41 passageway 45 or a gap 55 between the outer
sheath inner surface 57 and the compression member outer surface
47.
[0256] The puller 54 may vary in length and height. The length may
vary from about 1 to 10 cm, from about 2 to 6 cm, and in one
embodiment has a length of approximately 5 cm. Optionally, the
puller could run approximately the length of the middle section
delivery device 14, or about 125 cm, so long as the puller height
increases at or near the proximal wire guide exit port 83 of the
outer guide channel member 80 to lift the inner compression member
41 and occlude the wire guide 16. The overall height, as measured
from a longitudinal axis of the distal portion 13 at or near the
exit port 83, also may vary. In one embodiment, the height
approximately equals or slightly exceeds the absolute difference
between the outer diameter 84 and the inner diameter 85. In another
embodiment, the height is from about 0.2 French to about 2.0
French, and in another the height approximates 1 French.
[0257] As a stiffening element, the puller 54 reduces the flexing,
buckling, kinking, or bending of the distal end at or near the exit
port 83. Moreover, the puller 54 may be used where structural
integrity is compromised, as in a case where the exit port 83 is a
large longitudinal gap and reduced material, low profile, and
circumference at the breech position opening 65 as shown in FIG.
20. Optionally, the construction of a bridge 100, as already
explained, may be modified for a puller 54, which may comprise any
suitable material used for a bridge.
[0258] As an optional occlusion element, the puller 54 may lift the
inner compression member or the wire guide 16 in order to ensure
that the wire guide 16 does not enter a passageway 45 (e.g., FIG.
7) of an inner compression member and/or the passageway 59 (e.g.,
FIGS. 6, 7, 8, 9) of the outer sheath 50. In other words, the wire
guide 16 may unintentionally enter that inner compression member
passageway 45 (e.g., FIG. 7) or outer sheath passageway 59 (e.g.,
FIGS. 6, 7, 8, 9) as the wire guide exits proximally from the
proximal wire guide exit port 83 of the outer guide channel member
80. By lifting the inner compression member and occluding the wire
guide, the wire guide 16 exits the distal portion 13 in a position
exterior to the outer sheath 50.
[0259] FIGS. 18 and 19 illustrate deployment of an embodiment of a
distal portion 13 having a puller 54. In FIG. 19, the distal
portion 13 is in an un-deployed position, while FIG. 18 depicts the
distal portion 13 in a deployed position after proximal retraction
of an outer guide channel member 80 relative to the inner guide
channel member 70. The wire guide 16 enters the distal portion 13
and then exits from a breech position opening 65 of the delivery
system at a substantially straight path so as to minimize kinking
of the wire guide, and then runs proximally along the outside
surface of the outer sheath 50. At or near the exit port 83, the
puller 54 produces a lift that causes the wire guide 16 to be
guided toward the exit port 83 and leave the outer guide channel
80.
[0260] FIG. 20 shows an embodiment of an outer guide channel member
80 used in a distal portion 13 having puller 54. The outer guide
channel member 80 comprises a wire guide entry port 82 and a
proximal wire guide exit port 83 defining a guide channel 81. The
outer guide channel member 80 has a first outer diameter 84 and a
proximal second smaller outer diameter 85 at or near the breech
position opening 65. The exit port 83 in this embodiment is sloped
in this embodiment, although any of the previously discussed
configurations would be suitable. The puller 54 is positioned at or
near the exit port 83 and extends proximal thereto a length as
previously described.
[0261] FIG. 21 shows an embodiment of an inner guide channel member
70 used in a distal portion 13 having a puller 54 according to
FIGS. 18-20 and an inner compression member 41. The puller lifts
the distal end of the inner compression member 41 at an optional
ramp 61 of a slight angle or grade in a transition region 60. This
lift helps to ensure that the guide channel 71 of the inner guide
channel member 70 is approximately aligned and substantially
coaxial with the outer member guide channel 81 and/or the exit port
83 (FIGS. 18-20). Alignment helps to facilitate transition of the
wire guide and to direct the wire guide from the outer member wire
guide entry port 82, through the guide channel 81, and toward the
breech position opening 65 located at or near the rear, back, or
the proximal part of the outer member second end portion 87 as
illustrated in FIGS. 18, 19, and 20.
[0262] FIG. 22 shows still another embodiment of a delivery system
having a breech position opening 65 for the rapid insertion of
self-expanding stents. This embodiment has several features that
add to the utility and ease of aspirating the stent mounting region
90 where a stent is positioned about a stent platform 91 on the
outside surface located at or near the distal end of the inner
guide channel member 70 intermediate distal tip of the inner member
and a proximal restraint 93, and is sandwiched between the platform
91 and the inner surface 92 of the outer guide channel member 80,
which controls premature deployment of the stent.
[0263] In this embodiment, the distal portion 13 of the device
comprises a venting structure. A flushing port 94 is positioned at
the distal portion of the stent mounting region 90 to aspirate air
out from inside the delivery system and from around the outer guide
channel member 80, thereby reducing the chance of air embolisms. In
addition, there may be a flushing pathway 74 in the outer diameter
75 of the inner member between the stent platform 91 and the
proximal wire guide exit port 73, thereby improving flow of air out
of the system in the area of the stent during air aspiration. Also,
the flushing port 94 may be formed in the outer guide channel
member 80 intermediate the stent mounting region 90 and the exit
port 83. Furthermore, the outer guide channel member exit port 83
may comprise a slit 186 for the wire guide to exit the distal
portion 13. In one embodiment, the distal end of the inner
compression member 41 passageway 45 may comprise a valve 61 such as
a simple flap or diaphragm type valve as previously explained for
purging air from the interior of the delivery system in the area of
the stent, and in a closed position may also act as an optional
guide to direct the wire guide toward the slit 186. It should be
understood that these venting structures are optional, and that the
device may include one or more of these structures.
[0264] FIGS. 23A and 23B are cross sectional schematic views taken
along lines A-A and B-B, respectively, of FIG. 22. FIG. 23A shows
an outer guide channel member 80, an inner guide channel member 70
having a channel 71, and a longitudinal groove vent 74 in the outer
diameter of the inner guide channel member 70. FIG. 23B shows a
cross sectional view of the inner compression member 41 defining a
passageway 45, the outer guide channel member 80 having a guide
channel 81, and a slit 186 formed in the outer guide channel member
80. The structures of FIGS. 23A and 23B are illustrative, and
alternative structures consistent with the venting feature of FIG.
22 are contemplated as being within this description.
[0265] FIG. 24 is a schematic side view of an alternative
embodiment of an elongate inner compression member 41 at or near a
distal portion of a delivery system having a breech position
opening for the rapid insertion of self-expanding stents. The
distal end of the inner compression member 41 has an increasing
degree of flattening at or near the exit port 83 so as to allow
bending and room for the wire guide to pass.
[0266] The inner compression member 41 may have the dimensions
(diameter, length) a previously described. Similarly, the inner
compression member 41 may comprise the materials as previously
described. In one embodiment, the inner compression member 41
comprises a proximal end 40, a middle section 40', and a distal
mating end 48 having an outer engaging surface 48'. Like elements
from the previous drawings, embodiments, and description from above
are labeled the same.
[0267] The overall length of the distal mating end 48 may vary. In
one embodiment, it is from about 1.0 mm to about 10.0 mm. In
another embodiment, the distal mating end 48 is approximately 3.0
mm. Furthermore, the distal mating end 48 optionally comprises a
decreasing height 148 (FIGS. 24, 24B) discussed below. The
decreasing height 148 may extend along the length of the distal
mating end 48 to the distal mating end outer engaging surface 48'
and/or to a contoured configuration 48'' that is described below.
In one embodiment, the decreasing height 148 occurs along a length
of about 3.0 mm, while in another embodiment the decreasing height
148 occurs over a much shorter length, such as approximately 0.5
mm. The contoured configuration 48'' and outer engaging surface 48'
may occur along the entire length of the distal mating end 48 or
the decreasing height 148. Alternatively, the distal mating end 48
has a decreasing height 148 down to the contoured configuration
48'' and outer engaging surface 48', and in one embodiment the
decreasing height 148 is about 0.5 mm in length while the contoured
configuration 48'' and outer engaging surface 48' may extend
distally from the decreasing height 148 and measure approximately
2.5 mm in length, for a distal mating end 48 that is approximately
3.0 mm in overall length.
[0268] FIGS. 24A and 24B show cross sectional views of FIG. 24
taken along the lines 24A-24A and 24B-24B, whereby the inner
compression member 41 in FIG. 24A has an approximate height (e.g.,
outer diameter or thickness) of approximately 0.024 inches and FIG.
24B shows an embodiment of a decreasing height 148 from less than
about 0.24 inches to greater than about 0.08 inches, and in one
embodiment the decreasing height 148 is approximately 0.016 inches
from top 148' to bottom 148''. The term "decreasing height" and
variations thereof describe embodiments of the invention, rather
than any lexicographic definition. For instance, the inner
compression member distal mating end 48 may gradually decrease from
top 148' to bottom 148'' over the length of the mating end 48 in a
variety of ways. In other words, the distal mating end 48 may have
a portion that becomes gradually lesser in height (FIG.
24B)--relative to the inner compression member 41 (FIG. 24A)--in
the distal direction. A decreasing height 148 may result from or be
measured in a height, thickness, cross-section, diameter, width,
and/or other configuration, shape, form, profile, structure,
external outline, and/or contour that is lesser in height from the
top 148', from the bottom 148'', or as shown in FIG. 24B from both
the top 148' and the bottom 148''. It should be understood that the
top 148' and bottom 148'' may be relative, and the inventions
includes without limitation an embodiment where top 148' and bottom
148'' are viewed end-on, a side view, or any view along the x-axis
and y-axis from 0 to 2.pi. (e.g., including the top 148' designated
from 0 radians and bottom might be .pi. radians). In one
embodiment, the top 148' is the portion facing the outer engaging
surface 164 of the base securing section 154.
[0269] While the decreasing height 148 may have a gradually smaller
cross sectional area when compared to the cross sectional area at
the inner compression member 41 (FIGS. 24, 24A) that is proximal to
the distal mating end 48, the cross sectional area need not
decrease. For example, the width might increase inversely
proportional to the decrease in height as shown in FIG. 24B,
although if desired the increased width could be cut away,
machined, trimmed, chipped, planed, and the like. Also, this is not
to say that the distal mating end 48 may only decrease in height.
Indeed, the decreasing height 148 might extend to a position at or
near the contoured configuration 48'', which might increase in
height, such as with an upward curve or other configuration that
reverses to form a fluted embodiment, a flare, or upward
protrusion. Furthermore, the distal mating end 48 may comprise more
than one portion having a decreasing height, whereby the distal
mating end 48 decreases in height from top 148' to bottom 148'',
then increases in height from top 148' to bottom 148'', only to
decrease again along the length of the distal mating end 48.
[0270] According to the invention, the inner compression member
distal mating end 48 and/or outer engaging surface 48' further
comprise a contoured configuration 48'' that is generally
complementary to the cannula 95 (e.g., FIGS. 9, 9A, 9B, 9C) and/or
the second end of the inner guide channel member (e.g., FIGS. 6, 7,
8, 9) as previously described. FIG. 24C, by way of example and not
by way of limitation, an embodiment of a contoured configuration
48'' and an outer engaging surface 48' taken along the line
24C-24C. In FIG. 24C, the contoured configuration 48'' and outer
engaging surface 48' are both flat. While the contoured
configuration 48'' has decreased in height relative to the inner
compression member 41 shown in the background with a circular cross
section, the contoured configuration 48'' in FIG. 24C has an
increased width.
[0271] The decreasing height 148 and the contoured configuration
48'' may be achieved by swaging, stamping, forging, or rolling
between two rollers. For example, rolling the shaft between rollers
of a mill will help to prevent any lessening of strength (i.e.,
fatigue strength) that could result if the decreasing height 148
and/or the contoured configuration 48'' were machined. It should be
understood that the shape of the inner compression member 41 can be
chosen depending on the shape of the cannula 95, the outer guide
channel member 80, and/or the inner guide channel member 70, and
the decreasing height 148 and/or the contoured configuration 48''
(or other configurations) may vary along the longitudinal axis of
the inner compression member 41. Furthermore, the degree of
flatness of an inner compression member 41 can determine the
flexibility in a certain direction.
[0272] FIGS. 25A through 25C are schematic alternative embodiments
of a distal portion 13 of a delivery system having a breech
position opening 65 for the rapid insertion of self-expanding
stents according to the invention. In these embodiments, the distal
portion 13 has a stepped 84, 85 profile comprising a first outer
diameter 84 and a second smaller outer diameter 85. The distal
portion 13 further comprises an inner guide channel member 70, an
outer guide channel member 80 axially slideable relative to the
inner guide channel member 70, a stent mounting region 90, and a
transition region 60.
[0273] FIGS. 25A and 25C show a two-piece embodiment of an outer
sheath 50 and an outer guide channel member 80 joined by any
suitable means as previously described. At or near the transition
region 60, the inner guide channel member 70 has an inner sheath
flange 176 that engages the outer sheath outer edge 152 on the
outside surface of the outer sheath 50 at an overlapping engagement
region 160. Because the flange 176 and outer sheath edge 152
overlap at the overlapping engagement region 160, this arrangement
facilitates a wire guide 16 to run along the outside of the outer
sheath instead of entering a lumen of the outer sheath or inner
compression member lumen (not shown) of the outer sheath. During
deployment, the length of the overlapping engagement region 160
will diminish as the outer guide channel member withdraws
proximally. In the non-deployed state, the overlapping engagement
region 160 of FIG. 25A has a lesser length than that region 160 of
FIG. 259B. Therefore, the distal portion 13 of FIG. 25A should have
a reduced length relative to the distal portion 13 of FIG. 25B.
[0274] FIG. 25C shows an integral outer sheath 50 and outer guide
channel member 80 formed from a continuous tube with a first outer
diameter 84 and a second smaller outer diameter 85. Like FIGS. 25A
and 25B, at or near the transition region 60, the inner guide
channel member 70 has an inner sheath flange 176 that engages the
outer sheath outer edge 152 on the outside surface of the outer
sheath 50 at an overlapping engagement region 160.
Methods
[0275] Methods of manufacturing and of providing a medical device
for delivering a self-expanding stent are also provided.
[0276] FIG. 26 shows a block diagram illustrating a method 300 of
providing (step 302) a delivery system 10 for the rapid insertion
of self-expanding stents comprising a system proximal portion 12; a
middle section delivery device 14; and a system distal portion 13
having an inner guide channel member 70 with a guide channel 71, an
outer guide channel member 80 axially slideable relative to the
inner guide channel member 70 and having a guide channel 81
arranged relative to the inner member guide channel 71 to reduce
any bending of the wire guide as the wire guide moves proximally
from the inner member guide channel 71 to the outer member guide
channel 81, and a stepped 84, 85 profile; and wherein the system
distal portion 13 further comprises a self-expanding deployment
device mounting region 90 (e.g., a stent mounting region), a
transition region 60, and a proximal breech opening 65 located at
or near the rear, back, or proximal part 87 of the distal portion
13. A self-expanding device 17 is loaded (step 304) into a radially
compressed state at the stent mounting region 90. The distal
portion 13 is slid over (step 306) a guiding device such as a wire
guide, catheter, and the like either by back-loading or
front-loading. The outer guide channel member 80 is retracted (step
308) proximally relative to the inner member so as to deploy the
stent 17.
[0277] FIG. 27 is a block diagram illustrating a method 400 of
manufacturing the invention as an alternative to purchasing the
inner and outer guide channel members 70, 80 and/or the outer
sheath 50 from Cook Incorporated. A first rectangular sheet 401 and
a second rectangular sheet 401' of inner and outer member 70, 80
materials are provided (step 402)--each sheet 401, 401' having
opposing A and B sides and opposing C and D sides. Opposing sides A
and B of the first sheet 401 are joined (step 404) to form an inner
guide channel member 70 having an entry port 72 at a first end
portion 78 and an exit port 73 at a second end portion 77, the
ports 72, 73 defining a guide channel 71, and a self-expanding
deployment device mounting region 90 (e.g., a stent mounting
region) intermediate the first and second end portions 78, 77,
respectively. Adjacent corners of side C of the second sheet 401'
are cut and the opposing sides A and B joined (step 406) to form an
outer guide channel member 80 having an entry port 82 at a first
end portion 88 (side D) and exit port 83 at a second end portion 87
(side C), the ports 82, 83 defining a guide channel 81, with the
outer member having a stepped 84, 85 profile, whereby the outer
member comprises a greater first outer diameter 84 at the first end
portion 88 and a second smaller outer diameter 85 located at or
near the outer member second end portion 87. Alternatively, when
joining opposing sides of a rectangular sheet, features such as
entry ports 72, 82 and exit ports 73, 83 and guide channels 71, 81
can be shaped from the open ends. Also, the configuration of the
exit port, such as an oblique shape for the outer member exit port
83, may be stamped or cut away from the sheet after joining the
edges (e.g., sides) of the sheet. The inner member is slidably
joined (step 408) within the second member guide channel 81. In all
of these manufacturing methods, the inner and outer members 70, 80,
respectively, may vary in length given the different sizes of the
vessels and vessel passageways intended for the use of the
device.
[0278] FIG. 28 is a block diagram illustrating a method 500 of
manufacturing a sheath for use with the middle section delivery
device 14 and/or distal portion 13, as another alternative to
purchasing the outer sheath 50 or the inner and outer guide channel
members 70, 80 from Cook Incorporated. When forming the middle
section delivery device 14 or distal portion 13 from a sheet of
material (such as a material comprising Teflon) consistent with the
outer sheath 50 or one of the members 70, 80, a sheet of material
for the inner layer 44 may be formed into a tubular body on a
mandrel and then heated in an oven while inside a shrink tube.
(Step 502). After cooling, the shrink tube is peeled off and, if
the tubular body inner layer 44 is to be used as an inner
compression member 41 or an inner guide channel member 70, the
mandril is removed. For assembling the outer sheath or the outer
guide channel member 80, the tubular body inner layer 44 is left on
the mandril while a coil 43 is wrapped around the tubular body
inner layer 44. (Step 504). A sheet of material for the outer layer
42 is then formed around the coil 43 layer of the tubular body
inner layer 44, and the mandril pulled out. (Step 506). In order to
assemble an outer guide channel member 80 with an eccentric stepped
84, 85 profile (i.e., a reduction in outer diameter) in the area of
the proximal wire guide exit hole (e.g., the exit port 83), the
outer guide channel member 80 is formed from material of inner
layer 44 on a mandril having a larger diameter 85 for a first end
portion 88 and a second mandril having a smaller diameter 84 (or
one mandril of these diameters 85, 84) according to the Steps 502
and 504 (the coil 43 step). Then, an outer layer 42 of material,
such as a Nylon and/or PEBA overcoat, is extended across the
mandrel outer diameter and across a step down diameter (i.e., the
second smaller outer diameter 85 relative to the first outer
diameter 84) at the proximal end of the mandrel, the assembly is
heated and shrunk together and, once cooled, the mandril pulled
out, and the second end portion 87 cut, machined, or milled in
order to provide the outer member wire guide exit port 83 and the
optional lateral walls 83a, 83b. (Step 508). This results in a
one-piece, multiple diameter delivery system outer guide channel
member 80 that has the advantages of a reinforced type of
restraining sheath in the area of the stent. Thus, outer guide
channel member permits the wire guide to exit without adding to the
diameter of the outer member and, in fact, presenting a lower
profile at or near the exit port 83 of the outer member.
[0279] FIG. 29 is a block diagram illustrating a method 600 of
manufacturing a delivery apparatus for the rapid insertion of
self-expanding devices. A middle section delivery device 14 having
an inner compression member 41 and outer sheath 50 and a passageway
59 and having an insert 130 comprising an outer sheath mating
portion 132 secured at or near an outer sheath distal end 50' and
having an interfacing portion 134 and guide channel 133 (as
described above and shown in the figures) is provided (step 602). A
distal portion 13 has an outer guide channel member 80 with a
second end portion 87 and an insert 120 comprising a distal insert
mating portion 122 secured at or near an outer member second end
portion 87 and having an interfacing portion 124 and guide channel
81' (as described above and shown in the figures) is provided (step
604), the distal portion 13 further having an inner guide channel
member 70 with an guide channel 71; the outer guide channel member
80 axially slideable relative to the inner guide channel member 70
and having a guide channel 81 and a stepped 84, 85 profile; a
self-expanding deployment device mounting region 90 (e.g., a stent
mounting region); a transition region 60; and a proximal breech
opening 65 located at or near the rear, back, or second end portion
87 of the distal portion 13.
[0280] Materials and methods of manufacturing a suitable middle
section delivery device 14 and distal portion 13 are described in
Published U.S. Patent Application 2004/0116833 (Koto et al.) and in
U.S. Pat. No. 6,589,227 (Sonderskov Klint, et al.; Assigned to Cook
Incorporated of Bloomington, Ind. and William Cook Europe of
Bjaeverskov, Denmark). The contents of the patent and patent
application are incorporated herein by reference. Examples further
include a multifilar embodiment and a "Flexor.RTM. sheath" as
described above and shown in the figures, or other component.
Furthermore, the "Flexor.RTM. sheath," manufactured and sold by
Cook Incorporated of Bloomington, Ind., may be adapted for use with
the distal portion 13 and/or the middle section delivery device 14.
The Flexor.RTM. sheath, as previously described and shown in the
figures above, may be provided for the distal portion 13 and/or the
middle section delivery device 14. In step 606, the insert
interfacing ends 124, 134 are brought together (step 606). The
interfacing ends 124, 134 are secured by a connector 110 (step
608).
[0281] A method of manufacturing and of providing a medical device
for delivering a self-expanding stent need not be performed
sequentially. For instance, in method 300, a self-expanding device
17 may be loaded (step 304) before the delivery system 10 is
provided (step 302). In method 400, the adjacent corners of side C
of the second sheet 401' may be cut and the opposing sides A and B
joined (step 406) to form an outer guide channel member 80 before
the inner member is formed by joining opposing sides A and B of the
first sheet 401 (step 404). In method 600, the distal portion 13
may be provided (step 604) before providing the middle section
delivery device 14 (step 602).
[0282] It is intended that the foregoing detailed description of
the delivery system and devices for the rapid insertion of
self-expanding stents be regarded as illustrative rather than
limiting, and that it be understood that it is the following
claims, including all equivalents, that are intended to define the
spirit and scope of this invention. Terms are to be given their
reasonable plain and ordinary meaning. Also, the embodiment of any
figure and features thereof may be combined with the embodiments
depicted in other figures. Other features known in the art and not
inconsistent with the structure and function of the present
invention may be added to the embodiments.
[0283] While particular elements, embodiments and applications of
the present invention have been shown and described, it will be
understood, of course, that the invention is not limited thereto
since modifications may be made by those skilled in the art,
particularly in light of the foregoing teachings. Therefore, it is
therefore contemplated by the appended claims to cover such
modifications as incorporate those features which come within the
spirit and scope of the invention.
* * * * *