U.S. patent application number 17/301425 was filed with the patent office on 2021-07-22 for method and apparatus for loading a guidewire into a connector with a valve.
The applicant listed for this patent is Corindus, Inc.. Invention is credited to Steven J. Blacker.
Application Number | 20210220624 17/301425 |
Document ID | / |
Family ID | 1000005495059 |
Filed Date | 2021-07-22 |
United States Patent
Application |
20210220624 |
Kind Code |
A1 |
Blacker; Steven J. |
July 22, 2021 |
METHOD AND APPARATUS FOR LOADING A GUIDEWIRE INTO A CONNECTOR WITH
A VALVE
Abstract
A guidewire introducer for loading a guidewire into a connector
with a valve. The guidewire introducer having a proximal end, a
distal end and a slit along a length of the guidewire introducer
between the proximal end and the distal end. The guidewire
introducer is sufficiently rigid to create a passageway to allow
the guidewire introducer to get past the valve without collapsing
and wherein the slit closes when the guidewire introducer is
inserted into the valve.
Inventors: |
Blacker; Steven J.;
(Framingham, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Corindus, Inc. |
Waltham |
MA |
US |
|
|
Family ID: |
1000005495059 |
Appl. No.: |
17/301425 |
Filed: |
April 2, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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15429985 |
Feb 10, 2017 |
10994102 |
|
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17301425 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/06 20130101;
A61B 34/00 20160201; A61M 39/10 20130101; A61M 25/09041
20130101 |
International
Class: |
A61M 25/09 20060101
A61M025/09; A61M 39/10 20060101 A61M039/10; A61M 39/06 20060101
A61M039/06; A61B 34/00 20060101 A61B034/00 |
Claims
1. A guidewire introducer for loading a guidewire into a connector
with a valve, the guidewire introducer comprising: a guidewire
introducer having a proximal end, a distal end and a slit along an
entire length of the guidewire introducer between the proximal end
and the distal end; the guidewire introducer being sufficiently
rigid to create a passageway to allow the guidewire introducer to
get past the valve without collapsing and wherein the slit closes
when the guidewire introducer is inserted into the valve; and the
guidewire introducer being removable from the guidewire using the
slit in the guidewire introducer without requiring the guidewire
introducer to be slid or threaded over a length of the guidewire to
a proximal end of the guidewire.
2. The guidewire introducer of claim 1, wherein the proximal end of
the guidewire introducer is tapered.
3. The guidewire introducer of claim 1, wherein the connector
includes a distal end and the distal end is connected to a guide
catheter.
4. The guidewire introducer of claim 1, wherein advancing the
guidewire through the guidewire introducer and through the
connector further comprises advancing the guidewire into a guide
catheter.
5. The guidewire introducer of claim 1, wherein the distal end of
the guidewire is flexible.
6. The guidewire introducer of claim 1, wherein the valve in the
connector is selected from a group of valves consisting of a
hemostasis valve, a bleed-back valve and a portion of a Tuohy Borst
adapter.
7. The guidewire introducer of claim 1, wherein the slit has a
spiral configuration along the length of the guidewire
introducer.
8. The guidewire introducer of claim 1, wherein at least a portion
of the slit springs open when the guidewire introducer is removed
from the valve.
9. The guidewire introducer of claim 1, wherein the guidewire
introducer is formed of a material having sufficient compliance to
allow the slit to close when the guidewire introducer is inserted
into the valve.
10. The guidewire introducer of claim 1, the slit overlaps itself
in response to insertion of the guidewire introducer into the
valve.
11. The guidewire introducer of claim 1, wherein the guidewire
introducer includes a first tapered portion proximate the proximal
end and a second tapered portion proximate the distal end, the
diameter of the first tapered portion decreasing from the proximal
end toward the distal end and the diameter of the second tapered
portion decreasing from the proximal distal end of the second
tapered portion toward the distal end of the second tapered
portion.
12. The guidewire introducer of claim 1, wherein portions of the
slit are open, with opposing edges of the portions of the slit
being spaced apart and out of mutual contact, prior to the
inserting of the guidewire introducer into a proximal end of the
connector and wherein positioning of the guidewire introducer into
the valve results in the portions of the slit closing.
13. The guidewire introducer of claim 12, wherein the slit closes
by overlapping itself in response to insertion of the guidewire
introducer into the valve.
14. The guidewire introducer of claim 12, wherein the opposing
edges of the portions of the slit are spaced apart by width greater
than or equal to a width of the guidewire prior to inserting the
guidewire introducer into the proximal end of the connector.
15. The guidewire introducer of claim 12, wherein the valve
constricts the portions of the slit to close the slit during
introduction of the portions of the slit into the valve.
16. The guidewire introducer of claim 12, wherein the slit closes
by overlapping itself in response to insertion of the guidewire
introducer into the valve.
17. A guidewire introducer for loading a guidewire into a connector
with a valve, the guidewire introducer comprising: a guidewire
introducer having a proximal end, a distal end and a slit along a
length of the guidewire introducer between the proximal end and the
distal end; wherein the guidewire introducer is sufficiently rigid
to create a passageway to allow the guidewire introducer to get
past the valve without collapsing and wherein the slit closes when
the guidewire introducer is inserted into the valve.
18. The guidewire introducer of claim 17, wherein the guidewire
introducer is formed of a material having sufficient compliance to
allow at least a portion of the slit to close when the guidewire
introducer is inserted into the valve and to spring open when the
guidewire introducer is removed from the valve.
19. The guidewire introducer of claim 18, wherein when the slit is
open opposing edges of the portions of the slit are spaced apart by
a width sufficient to allow a guidewire to be inserted into the
passageway through the slit.
20. The guidewire introducer of claim 19, wherein the slit extends
along an entire length of the guidewire introducer and wherein the
guidewire introducer may be removed from the guidewire using the
slit without requiring the guidewire introducer to be slid or
threaded over the length of the guidewire to a proximal end of the
guidewire.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 15/429,985, filed Feb. 10, 2017, titled METHOD AND APPARATUS
FOR LOADING A GUIDEWIRE INTO A CONNECTOR WITH A VALVE, which is
incorporated herein by reference in its entirety.
FIELD OF THE INVENTION
[0002] The present invention relates generally to the field of
catheter systems for performing therapeutic procedures and, in
particular, to a method and apparatus for loading a guidewire into
a connector with a valve.
BACKGROUND OF THE INVENTION
[0003] Catheters may be used for many medical procedures, including
inserting a guidewire, delivering a stent and delivering and
inflating a balloon. Catheterization procedures are commonly
performed for diagnosis and treatment of diseases of the heart and
vascular systems. The catheterization procedure is generally
initiated by inserting a guidewire into a blood vessel in the
patient's body. The guidewire is then advanced to the desired
location, most commonly in one of the heart vessels or elsewhere in
the vascular system. At this point, a catheter is slid over the
guidewire into the blood vessel and/or heart. In some procedures,
the catheter is a balloon catheter or stent delivery system that
when deployed at the site of the lesion allows for increased blood
flow through the portion of the coronary artery that is affected by
the lesion.
[0004] For manual insertion of a guidewire, the physician applies
torque and axial push force on the proximal end of a guidewire to
effect tip direction and axial advancement at the distal end.
Robotic catheter procedure systems have been developed that may be
used to aid a physician in performing a catheterization procedure
such as a percutaneous coronary intervention (PCI). The physician
uses a robotic system to precisely steer a coronary guidewire,
balloon catheter or stent delivery system in order to, for example,
widen an obstructed artery. While observing the coronary anatomy
using fluoroscopy, the physician manipulates a device, for example
a guidewire, in order to direct the device into the appropriate
vessels toward the lesion. A robotic catheter procedure system
includes drive mechanisms to drive various elongated medical
devices (e.g., guidewire, guide catheter, working catheter) used in
catheterization procedures to provide linear and rotational
movement of the elongated medical device.
[0005] During one type of catheter procedure, a guide catheter is
inserted into either a patient's femoral or radial artery through
an introducer and the guide catheter is positioned proximate the
coronary ostium of the patient's heart. During the procedure, the
guide catheter is used to guide other elongated medical devices
such as a guidewire or a balloon catheter into a patient.
Typically, the end of the guide catheter not inserted into the
patient is connected to a connector, such as a y-connector, with a
valve (e.g., a hemostasis valve) to allow introduction of an
elongated medical device and a contrast agent or medicine into a
lumen of the guide catheter. For example, a first leg of the
y-connector may be configured to receive a guidewire or other
elongated medical device and a second leg of the y-connector may be
configured to allow introduction of a contrast agent or medicine.
The first leg of a y-connector may also include a valve that
permits insertion or removal of the guidewire or other elongated
medical device but prohibits fluids from exiting the first leg. A
guidewire may have a flexible or floppy end which can be difficult
to insert past the valve in the connector. It would be desirable to
provide an apparatus and method for loading a guidewire into a
connector that allows the flexible end of the guidewire to advance
past a valve in the connector and that allows the guidewire
introducer to be removed proximate to the connector without having
to thread the guidewire introducer off the entire length of the
guidewire to the proximal end of the guidewire.
SUMMARY OF THE INVENTION
[0006] In accordance with an embodiment, a method for loading a
guidewire into a connector using a guidewire introducer includes
inserting a guidewire introducer into a proximal end of a
connector, the guidewire introducer having a proximal end, a distal
end and a slit along the length of the guidewire introducer between
the proximal end and the distal end, advancing the guidewire
introducer past a valve in the proximal end of the connector,
inserting a distal end of a guidewire into the proximal end of the
guidewire introducer, advancing the guidewire through the guidewire
introducer and through the connector, removing the guidewire
introducer from the connector so that the distal end of the
guidewire introducer is outside of the connector and proximate to
the proximal end of the connector and removing the guidewire
introducer from the guidewire using the slit in the guidewire
introducer.
[0007] In accordance with another embodiment, a guidewire
introducer for loading a guidewire into a connector with a valve
includes a body having a length, a proximal end and a distal end, a
slit having a spiral configuration along the length between the
proximal end and the distal end and a tapered portion at the
proximal end.
[0008] In accordance with another embodiment, a guidewire
introducer for loading a guidewire into a connector with a valve
includes a body having a length, a proximal end and a distal end, a
slit having a zig-zag configuration along the length between the
proximal end and the distal end and a tapered portion at the
proximal end.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] This application will become more fully understood from the
following detailed description, taken in conjunction with the
accompanying figures, wherein like reference numerals refer to like
elements in which:
[0010] FIG. 1 is a perspective view of an exemplary catheter
procedure system in accordance with an embodiment;
[0011] FIG. 2 is a perspective view of an exemplary y-connector in
accordance with an embodiment;
[0012] FIG. 3 is a perspective view of a y-connector and guide
catheter in accordance with an embodiment;
[0013] FIG. 4 is a perspective view of a guidewire introducer with
a lengthwise slit in accordance with an embodiment;
[0014] FIG. 5 is a perspective view of a guidewire introducer with
a spiral slit in accordance with an embodiment;
[0015] FIG. 6 is a perspective view of a guidewire introducer with
a spiral slit in accordance with an embodiment;
[0016] FIG. 7 illustrates a method for loading a guidewire into a
connector in accordance with an embodiment;
[0017] FIG. 8 is a perspective view of a guidewire introducer
positioned within a y-connector in accordance with an
embodiment;
[0018] FIG. 9 is a perspective view of a y-connector, guide
catheter; guidewire introducer and guidewire in accordance with an
embodiment;
[0019] FIG. 10 is a perspective view of a guidewire positioned
within a guidewire introducer in accordance with an embodiment;
[0020] FIG. 11 is a perspective view of a y-connector, guide
catheter, guidewire introducer and guidewire in accordance with an
embodiment; and
[0021] FIG. 12 is a perspective view of a y-connector, guide
catheter and guidewire in accordance with an embodiment.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0022] FIG. 1 is a perspective view of an exemplary catheter
procedure system in accordance with an embodiment. In FIG. 1, a
catheter procedure system 100 may be used to perform catheter based
medical procedures (e.g., a percutaneous intervention procedure).
Catheter based medical procedures may include diagnostic
catheterization procedures during which one or more catheters are
used to aid in the diagnosis of a patient's disease. For example,
during one embodiment of a catheter based diagnostic procedure, a
contrast media is injected onto one or more coronary arteries
through a catheter and an image of the patient's heart is taken.
Catheter based medical procedures may also include catheter based
therapeutic procedures (e.g., angioplasty, stent placement,
treatment of peripheral vascular disease, etc.) during which a
catheter is used to treat a disease. It should be noted, however,
that one skilled in the art would recognize that certain specific
percutaneous intervention devices or components (e.g., type of
guidewire, type of catheter, etc.) will be selected based on the
type of procedure that is to be performed. Catheter procedure
system 100 is capable of performing any number of catheter based
medical procedures with minor adjustments to accommodate the
specific percutaneous intervention devices to be used in the
procedure. In particular, while the embodiments of catheter
procedure system 100 described herein are explained primarily in
relation to the treatment of coronary disease, catheter procedure
system 100 may be used to diagnose and/or treat any type of disease
or condition amenable to diagnosis and/or treatment via a catheter
based procedure.
[0023] Catheter procedure system 100 includes lab unit 106 and
workstation 116. Catheter procedure system 100 includes a robotic
catheter system, shown as bedside system 110, located within lab
unit 106 adjacent a patient 102. Patient 102 is supported on a
table 108. Generally, bedside system 110 may be equipped with the
appropriate percutaneous intervention devices or other components
(e.g., guidewires, guide catheters, working catheters such as
balloon catheters and stent delivery systems, contrast media,
medicine, diagnostic catheters, etc.) to allow the user to perform
a catheter based medical procedure via a robotic system by
operating various controls such as the controls located at
workstation 116. Bedside system 110 may include any number and/or
combination of components to provide bedside system 110 with the
functionality described herein. Bedside system 110 includes, among
other elements, a drive assembly 114 (e.g., that may contain a
sterile, disposable portion) supported by a robotic arm 112 which
may be used to automatically advance a guidewire or working
catheter into a guide catheter seated in an artery of the patient
102.
[0024] Bedside system 110 is in communication with workstation 116,
allowing signals generated by the user inputs of workstation 116 to
be transmitted to bedside system 110 to control the various
functions of bedside system 110. Bedside system 110 may also
provide feedback signals (e.g., operating conditions, warning
signals, error codes, etc.) to workstation 116. Bedside system 110
may be connected to workstation 116 via a communication link that
may be a wireless connection, cable connections, or any other means
capable of allowing communication to occur between workstation 116
and bedside system 110.
[0025] Workstation 116 includes a user interface 126 configured to
receive user inputs to operate various components or systems of
catheter procedure system 100. User interface 126 includes controls
118 that allow the user to control bedside system 110 to perform a
catheter based medical procedure. For example, controls 118 may be
configured to cause bedside system 110 to perform various tasks
using the various percutaneous intervention devices with which
bedside system 110 may be equipped (e.g., to advance, retract, or
rotate a guidewire, advance, retract or rotate a working catheter,
advance, retract, or rotate a guide catheter, inflate or deflate a
balloon located on a catheter, position and/or deploy a stent,
inject contrast media into a catheter, inject medicine into a
catheter, or to perform any other function that may be performed as
part of a catheter based medical procedure). Drive assembly 114
includes various drive mechanisms to cause movement (e.g., axial
and rotational movement) of the components of the bedside system
110 including the percutaneous devices.
[0026] In one embodiment, controls 118 include a touch screen 124,
one or more joysticks 128 and buttons 130, 132. The joystick 128
may be configured to advance, retract, or rotate various components
and percutaneous devices such as, for example, a guidewire, a guide
catheter or a working catheter. Buttons 130, 132 may include, for
example, an emergency stop button and a multiplier button. When an
emergency stop button is pushed a relay is triggered to cut the
power supply to bedside system 110. Multiplier button acts to
increase or decrease the speed at which the associated component is
moved in response to a manipulation of controls 118. In one
embodiment, controls 118 may include one or more controls or icons
(not shown) displayed on touch screen 124, that, when activated,
causes operation of a component of the catheter procedure system
100. Controls 118 may also include a balloon or stent control that
is configured to inflate or deflate a balloon and/or a stent. Each
of the controls may include one or more buttons, joysticks, touch
screen, etc. that may be desirable to control the particular
component to which the control is dedicated. In addition, touch
screen 124 may display one or more icons (not shown) related to
various portions of controls 118 or to various components of
catheter procedure system 100.
[0027] User interface 126 may include a first monitor or display
120 and a second monitor or display 122. First monitor 120 and
second monitor 122 may be configured to display information or
patient specific data to the user located at workstation 116. For
example, first monitor 120 and second monitor 122 may be configured
to display image data (e.g., x-ray images, MRI images, CT images,
ultrasound images, etc.), hemodynamic data (e.g., blood pressure,
heart rate, etc.), patient record information (e.g., medical
history, age, weight, etc.). In addition, first monitor 120 and
second monitor 122 may be configured to display procedure specific
information (e.g., duration of procedure, catheter or guidewire
position, volume of medicine or contrast agent delivered, etc.).
Monitor 120 and monitor 122 may be configured to display
information regarding the position the guide catheter. Further,
monitor 120 and monitor 122 may be configured to display
information to provide the functionalities associated with a
controller of the system (e.g., located in workstation 116 or in
communication with workstation 116). In another embodiment, user
interface 126 includes a single screen of sufficient size to
display one or more of the display components and/or touch screen
components discussed herein.
[0028] Catheter procedure system 100 also includes an imaging
system 104 located within lab unit 106. Imaging system 104 may be
any medical imaging system that may be used in conjunction with a
catheter based medical procedure (e.g., non-digital x-ray, digital
x-ray, CT, MRI, ultrasound, etc.). In an exemplary embodiment,
imaging system 104 is a digital x-ray imaging device that is in
communication with workstation 116. In one embodiment, imaging
system 104 may include a C-arm (not shown) that allows imaging
system 104 to partially or completely rotate around patient 102 in
order to obtain images at different angular positions relative to
patient 102 (e.g., sagittal views, caudal views, anterior-posterior
views, etc.).
[0029] Imaging system 104 may be configured to take x-ray images of
the appropriate area of patient 102 during a particular procedure.
For example, imaging system 104 may be configured to take one or
more x-ray images of the heart to diagnose a heart condition.
Imaging system 104 may also be configured to take one or more x-ray
images during a catheter based medical procedure (e.g., real time
images) to assist the user of workstation 116 to properly position
a guidewire, guide catheter, stent, etc. during the procedure. The
image or images may be displayed on first monitor 120 and/or second
monitor 122. In particular, images may be displayed on first
monitor 120 and/or second monitor 122 to allow the user to, for
example, accurately move a guide catheter into the proper
position.
[0030] As used herein, the direction distal is the direction toward
the patient and the direction proximal is the direction away from
the patient. The terms up and upper refer to the general direction
away from the direction of gravity and the terms bottom, lower and
down refer to the general direction of gravity.
[0031] Bedside system 110 of catheter procedure system 100 may
include a connector that may be in communication with a guide
catheter, guidewire and a working catheter. The connector includes
a valve, e.g., a hemostasis valve. The following description
discusses embodiments with respect to a y-connector, however, it
should be understood that the connector may be any other type of
connector including a valve such as a straight connector (e.g., a
connector with a single leg). FIG. 2 is a perspective view of an
exemplary y-connector in accordance with an embodiment. In one
embodiment, y-connector 200 is a hemostasis valve. Y-connector 200
includes a valve body with a first leg 202 having a proximal end
204, a distal end 206 and a lumen extending between the proximal
end 204 and the distal end 206. A proximal port or opening 205 is
adjacent to the proximal end 204 and a distal port or opening 207
is adjacent the distal end 206. The first leg 202 defines a
longitudinal axis 210 extending from the proximal end 204 of the
first leg 202 to the distal end 206 of the first leg 202. The
y-connector 200 also includes a second leg 208 that is angled away
from the longitudinal axis 210 defined by the first leg 202. The
second leg 208 includes an internal lumen and is in fluid
communication with the lumen of the first leg 202.
[0032] The first leg 202 of y-connector 200 includes a valve
adjacent to the proximal end 204 that permits insertion and removal
of a percutaneous device such as a guidewire or working catheter
into the y-connector 200 and prohibits fluids from exiting the
proximal end 204 of the first leg 202. In one embodiment, the valve
may be a bleed-back valve that may be used to reduce the blood that
may be lost during an interventional procedure. The bleed-back
valve acts to allow an elongated device such as a guidewire to
extend therethrough but minimizes blood loss through the valve. In
another embodiment, the proximal end 204 of the first leg 202 may
include a Tuohy Borst adapter. Tuohy Borst adapters are known in
the art and operate to adjust the size of the opening 205 in the
proximal end 204 of the first leg 202 of the y-connector 200 to
minimize the risk that fluids may exit the proximal end 204 of the
first leg 202. For example, a Tuohy Borst adapter may be used to
adjust the size of the opening to zero to stop flow of fluid or may
be used to adjust to opening to hold onto or fixate an elongated
medical device (e.g., a guidewire) that is passing through it. In
another embodiment, the connector (e.g., y-connector 200) may
include both a bleed-back valve and a Tuohy Borst adapter. Other
types of adapters known in the art may be used with the y-connector
200 to adjust the size of the opening 205 in the proximal end 204
of the first leg 202.
[0033] The distal end 206 of the first leg 202 may be connected to
a guide catheter as shown in FIG. 3. In FIG. 3, a guide catheter
212 has a proximal end 214 and a distal end 216. The proximal end
214 of the guide catheter 212 is attached to the distal end 206 of
the first leg 202 of the y-connector 200. In one embodiment, the
distal end 206 of the first leg 202 is attached to the proximal end
214 of the guide catheter 212 such that the central lumen of
y-connector 200 is in fluid communication with the central lumen of
the guide catheter 212. The second leg 208 of the y-connector 200
provides a port for the introduction of fluids (e.g., contrast
media, medicine, etc.) into the lumen of the guide catheter 212. An
elongated medical device such as a guidewire or working catheter
may be advanced into the guide catheter 212 through the y-connector
200. For example, a guidewire (not shown) may be inserted into the
proximal end 204 of the first leg 202 and through the first leg 202
of the y-connector 200 into the lumen of the guide catheter
212.
[0034] A guidewire introducer may be used to facilitate insertion
of a guidewire into the y-connector and past the valve in the
proximal end of the first leg of the y-connector. FIG. 4 is a
perspective view of a guidewire introducer with a lengthwise slit
in accordance with an embodiment. The guidewire introducer 220
includes a proximal end 222 and a distal end 224. The proximal end
222 includes a tapered portion 228 to allow insertion of a
guidewire into the proximal end 222 of the guidewire introducer
220. The guidewire introducer 220 also includes a slit 226 that is
continuous along the entire length of the guidewire introducer 220
between the proximal end 222 and the distal end 224. In one
embodiment, the guidewire introducer 220 has sufficient rigidity to
allow the guidewire introducer 220 to go through the valve and
create a passageway to allow the guidewire introducer to go through
the valve and create a passageway to allow a guidewire to get past
the valve without collapsing or damaging the distal tip of the
guidewire. In one embodiment, the slit 226 may be configured to
close when it is inserted in the valve in a manner such as a spring
pin or to close and overlap itself in a manner such as a coiled
spring pin and then open again when removed from the valve. For
example, the compliance of the material used to construct the
guidewire introducer 220 may be selected to allow the slit 226 to
close or to overlap itself when the guidewire introducer 220 is
inserted into the valve and to allow the slit 226 to spring open
when the guidewire introducer 220 is removed from the valve. The
slit 226 may have a width that is similar to the width of the
guidewire, smaller than the guidewire or larger than the
guidewire.
[0035] As discussed further below, the slit 226 may be used to
remove the guidewire introducer 220 from over a guidewire without
requiring the guidewire introducer 220 be slid or threaded over the
length of the guidewire to a proximal end of the guidewire. In an
embodiment, the proximal end 222 of the guidewire introducer 220
may include a tab (not shown) that may be used to remove (e.g.,
pull the introducer off of a guidewire). The tab (not shown) may be
positioned on the tapered portion 228 opposite the slit 226. In
another embodiment, the guidewire introducer with slit includes a
spiral slit along the length of the guidewire introducer as shown
in FIGS. 5 and 6. In FIG. 5, the guidewire introducer 250 includes
a proximal end 252 and a distal end 254. The proximal end 252
includes a tapered portion 258 to allow insertion of a guidewire
into the proximal end 252. A slit 256 is provided along the length
of the guidewire introducer 250 between the proximal end 252 and
the distal end 254. The slit 256 is in a spiral configuration along
the length of the guidewire introducer 250. In FIG. 6, an
alternative spiral configuration of a slit 260 along the length of
the guidewire introducer 250 is shown. In another embodiment, the
slit along the length of the guidewire introducer between the
proximal end and the distal end may be a zig-zag configuration. In
yet another embodiment, the slit may be straight along a portion of
the length of the guidewire introducer (e.g., proximate the
proximal end) and then a spiral or zig-zag configuration along the
remaining portion of the length of the guidewire introducer towards
the distal end.
[0036] The following description of FIGS. 7-12 discusses
embodiments with respect to a y-connector, however, it should be
understood that the connector may be any other type of connector
including a valve (e.g., a hemostasis valve) such as a straight
connector (e.g., a connector with a single leg). FIG. 7 illustrates
a method for loading a guidewire into a connector in accordance
with an embodiment. At block 302, a guidewire introducer with a
slit is inserted into the proximal end of the first leg of the
y-connector. At block 304, the guidewire introducer is advanced
past the valve in the proximal end of the first leg of the
y-connector and towards the distal end of the first leg of the
y-connector. FIG. 8 is a perspective view of a guidewire introducer
positioned within a y-connector in accordance with an embodiment.
In FIG. 8, the guidewire introducer 220 is shown after insertion
into the proximal end 204 of first leg 202 of the y-connector 200.
The guidewire introducer 220 is advanced through the first leg 202
past the valve in the proximal end 204 and towards the distal end
206 of the first leg 202.
[0037] Returning to FIG. 7, at block 306, a distal end of a
guidewire is inserted into the proximal end of the guidewire
introducer. FIG. 9 is a perspective view of a y-connector, guide
catheter; guidewire introducer and guidewire in accordance with an
embodiment. In FIG. 9, a guidewire 230 incudes a distal end 232
that may be inserted into the proximal end 222 of the guidewire
introducer 220. In one embodiment, the distal end 232 of the
guidewire may be flexible or bendable to put a curve at the tip. In
another embodiment, the distal end of the guidewire may be
pre-shaped with a curve. Returning to FIG. 7, at block 308, the
distal end of the guidewire is advanced through the guidewire
introducer and y-connector into the guide catheter. FIG. 10 is a
perspective view of a guidewire positioned within a guidewire
introducer in accordance with an embodiment. In FIG. 10, the
guidewire 230 is shown after the distal end has been inserted into
the guidewire introducer 220 and through the y-connector 200 into
the guide catheter 212. The guidewire introducer 220 facilitates
advancement of the distal end 232 (shown in FIG. 9) of the
guidewire 230 past the valve in the proximal end 204 of the first
leg 202 of the y-connector 200.
[0038] Returning to FIG. 7, at block 310 once the guidewire is
advanced into the guide catheter, the guidewire introducer is
removed from the y-connector over the guidewire until the distal
end of the guidewire introducer is outside of the y-connector and
proximate to the proximal end of the y-connector. FIG. 11 is a
perspective view of a y-connector, guide catheter, guidewire
introducer and guidewire in accordance with an embodiment. In FIG.
11, the guidewire introducer 220 is shown after removal from the
y-connector 200. The guidewire introducer 220 is positioned over
the guidewire and the distal end 224 of the guidewire introducer
220 is proximate to the proximal end 204 of the y-connector 200.
Returning to FIG. 7, at block 312, the guidewire introducer is
removed from the guidewire via the lengthwise slit 226 (shown in
FIG. 11) in the guidewire introducer. FIG. 12 is a perspective view
of a y-connector, guide catheter and guidewire in accordance with
an embodiment. In FIG. 12, the guidewire introducer has been
removed and the guidewire 230 is positioned in the y-connector 200
and guide catheter 212. Referring to FIG. 4 and FIG. 11 The
guidewire introducer includes a first tapered portion proximate the
proximal end 222 and a second tapered portion proximate the distal
end 224, the diameter of the first tapered portion decreasing from
the proximal end 222 toward the distal end 224 and the dimeter of
the second tapered portion decreasing from a region proximal the
distal end 224 of the second tapered portion toward the distal end
224 of the second tapered portion.
[0039] This written description used examples to disclose the
invention, including the best mode, and also to enable any person
skilled in the art to make and use the invention. The patentable
scope of the invention is defined by the claims, and may include
other examples that occur to those skilled in the art. Such other
examples are intended to be within the scope of the claims if they
have structural elements that do not differ from the literal
language of the claims, or if they include equivalent structural
elements with insubstantial differences from the literal language
of the claims. The order and sequence of any process or method
steps may be varied or re-sequenced according to alternative
embodiments.
[0040] Many other changes and modifications may be made to the
present invention without departing from the spirit thereof. The
scope of these and other changes will become apparent from the
appended claims.
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