U.S. patent application number 14/020538 was filed with the patent office on 2014-03-06 for system for guide catheter control.
This patent application is currently assigned to CORINDUS, INC.. The applicant listed for this patent is Corindus, Inc.. Invention is credited to Steven J. Blacker.
Application Number | 20140066900 14/020538 |
Document ID | / |
Family ID | 50188488 |
Filed Date | 2014-03-06 |
United States Patent
Application |
20140066900 |
Kind Code |
A1 |
Blacker; Steven J. |
March 6, 2014 |
SYSTEM FOR GUIDE CATHETER CONTROL
Abstract
A system for the advancement or retraction of a guide catheter
has a base member, support, linear actuator and bedside support.
The base member has a hemostasis valve affixed which includes a
valve body with a first leg having a proximal port, a distal port
and a lumen with a linear axis extending between the proximal port
and the distal port. At least one valve is located in the lumen
adjacent the proximal port to permit an interventional device to be
passed therethrough. The valve body has a second leg extending at
an angle relative to the first leg and has a lumen in fluid
communication with the lumen of the first leg. The support is
affixed to the base member such that it functions to move the base
member and its affixed valve in concert with the movement of the
linear actuator along its linear axis. The liner actuator to which
the support is affixed has a linear axis along which it may be
advanced or retracted in a continuous or incremental manner. The
bedside support is slidingly affixed to the linear actuator to
allow the linear actuator to move relative to the bedside
support.
Inventors: |
Blacker; Steven J.;
(Framingham, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Corindus, Inc. |
Waltham |
MA |
US |
|
|
Assignee: |
CORINDUS, INC.
Waltham
MA
|
Family ID: |
50188488 |
Appl. No.: |
14/020538 |
Filed: |
September 6, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61697734 |
Sep 6, 2012 |
|
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|
61699711 |
Sep 11, 2012 |
|
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|
61832227 |
Jun 7, 2013 |
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Current U.S.
Class: |
604/510 ;
604/95.01 |
Current CPC
Class: |
A61M 25/0147 20130101;
A61M 25/0116 20130101; A61M 39/06 20130101; A61M 25/02 20130101;
A61M 25/0075 20130101; A61B 1/00133 20130101; A61M 25/09 20130101;
A61M 25/065 20130101; A61B 34/30 20160201; A61B 2034/301
20160201 |
Class at
Publication: |
604/510 ;
604/95.01 |
International
Class: |
A61M 25/02 20060101
A61M025/02; A61M 25/01 20060101 A61M025/01 |
Claims
1. An apparatus comprising: a base member to which is affixed a
hemostasis valve including a valve body with a first leg having a
proximal port, a distal port and a lumen with a linear axis
extending between the proximal port and the distal port, at least
one valve being located in the lumen adjacent the proximal port to
permit an interventional device to be passed therethrough, the
valve body including a second leg extending at an angle relative to
the first leg and having a lumen in fluid communication with the
lumen of the first leg,; a support which is affixed to the base
member; a liner actuator to which the support is affixed that has a
linear axis along which it may be advanced or retracted in a
continuous or incremental manner; and a bedside support to which
the linear actuator is slidingly affixed to allow the linear
actuator to move relative to the bedside support, wherein the
support functions to move the base member and its affixed valve in
concert with the movement of the linear actuator along its linear
axis.
2. The apparatus of claim 1 wherein a track is affixed to the
bedside support with a liner axis parallel to or coincident with
the linear axis of the linear actuator, extending from an end
proximal to the bedside support to a distal end which extends
toward a patient and carrying a channel extending along its linear
axis configured to contain a guide catheter in a portion of its
length.
3. The apparatus of claim 2 wherein the linear axis of the lumen of
the first leg of the hemostasis valve intersects the linear axis of
the track at an acute angle as measured from the vertex that
generally faces the support.
4. The apparatus of claim 3 wherein the linear axis of the track is
inclined at an acute angle to the horizontal with the portion
affixed to the bedside support being elevated relative to the its
distal end.
5. The apparatus of claim 4 wherein the opening of the channel in
the track is inclined at an acute angle to the horizontal.
6. The apparatus of claim 4 wherein the opening of the channel in
the track generally faces toward the hemostasis valve.
7. The apparatus of claim 4 wherein the linear axis of the lumen of
the first leg of the hemostasis valve is inclined at the same angle
to the horizontal as the linear axis of the track.
8. The apparatus of claim 2 wherein the hemostasis valve has a
rotating male luer lock connector rotatably connected to the first
leg proximate the distal port configured to secure a guide catheter
thereto, the rotating male luer lock connector having a driven
member configured to be rotatably driven by a drive mechanism.
9. An apparatus comprising: a base member which is configured to
have a hemostasis valve including a valve body with a first leg
having a proximal port, a distal port and a lumen with a linear
axis extending between the proximal port and the distal port, at
least one valve being located in the lumen adjacent the proximal
port to permit an interventional device to be passed therethrough,
the valve body including a second leg extending at an angle
relative to the first leg and having a lumen in fluid communication
with the lumen of the first leg affixed to it such that the distal
port would be directed toward a patient; a support which is affixed
to the base member; a liner actuator to which the support is
affixed that has a linear axis along which it may be advanced or
retracted in a continuous or incremental manner; and a bedside
support to which the linear actuator is slidingly affixed to allow
the linear actuator to move relative to the bedside support,
wherein the support functions to move the base member in concert
with the movement of the linear actuator along its linear axis and
wherein the linear axis of the lumen of the first leg of the
hemostasis valve intersects the linear axis of the linear actuator
at an acute angle as measured from the vertex that generally faces
the support.
10. The apparatus of claim 9 wherein a track is affixed to the
bedside support with a liner axis parallel to or coincident with
the linear axis of the linear actuator, extending from an end
proximal to the bedside support to a distal end which extends
toward a patient and carrying a channel extending along its linear
axis configured to contain a guide catheter in a portion of its
length.
11. The apparatus of claim 10 wherein the linear axis of the track
is inclined at an acute angle to the horizontal with the portion
affixed to the bedside support being elevated relative to the its
distal end.
12. The apparatus of claim 11 wherein the opening of the channel in
the track is inclined at an acute angle to the horizontal.
13. The apparatus of claim 12 wherein the opening of the channel in
the track generally faces toward the base member.
14. The apparatus of claim 11 wherein the base member is configured
to have the hemostasis valve affixed to it such that the linear
axis of the lumen of the first leg of the hemostasis valve is
inclined at the same angle to the horizontal as the linear axis of
the track.
15. A method of adjusting the placement of a guide catheter in the
blood vessel of a human patient comprising; providing a base member
which is configured to have a hemostasis valve including a valve
body with a first leg having a proximal port, a distal port and a
lumen with a linear axis extending between the proximal port and
the distal port, at least one valve being located in the lumen
adjacent the proximal port to permit an interventional device to be
passed therethrough, the valve body including a second leg
extending at an angle relative to the first leg and having a lumen
in fluid communication with the lumen of the first leg affixed to
it such that the distal port would be directed toward a patient;
providing a support which is affixed to the base member; providing
a liner actuator that has a linear axis along which it may be
advanced or retracted in a continuous or incremental manner and to
which the support is affixed in such a way that it functions to
move the base member in concert with the movement of the linear
actuator along its linear axis; providing a bedside support to
which the linear actuator is slidingly affixed to allow the linear
actuator to move relative to the bedside support; affixing the
hemostasis valve to the base member; affixing a guide catheter to
the distal port of the first leg of the hemostasis valve providing
a controller to control the linear actuator; and providing
instructions to the controller via a user input to advance or
retract the linear actuator along its longitudinal axis.
16. The method of claim 15 wherein a track is affixed to the
bedside support with a liner axis parallel to or coincident with
the linear axis of the linear actuator, extending from an end
proximal to the bedside support to a distal end which extends
toward a patient, affixed such that its linear axis intersects the
linear axis of the lumen of the first leg of the hemostasis valve
at an acute angle as measured from the vertex that generally faces
the support and carrying a channel extending along its linear axis
configured to contain a guide catheter in a portion of its
length.
17. The method of claim 16 wherein the linear axis of the track is
inclined at an acute angle to the horizontal with the portion
affixed to the bedside support being elevated relative to the its
distal end.
18. The method of claim 16 wherein the opening of the channel in
the track is inclined at an acute angle to the horizontal and a
portion of the guide catheter has been inserted into a portion of
this channel.
19. The method of claim 15 wherein the hemostasis valve has a
rotating male luer lock connector rotatably connected to the first
leg proximate the distal port and secured to the guide catheter,
the rotating male luer lock connector having a driven member
configured to be rotatably driven by a drive mechanism.
20. The method of claim 19 wherein a drive mechanism and a
controller for the drive mechanism are provided and instructions
are provide to the controller via a user input interface to rotate
the rotational drive motor, drive member and driven member to
rotate the guide catheter along its longitudinal axis.
Description
CROSS-REFERENCE TO RELATED PATENT APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/832,227, filed Jun. 7, 2013, entitled "GUIDE
CATHETER DRIVE", and U.S. Provisional Application No. 61/699,711,
filed Sep. 11, 2012, entitled "HEMOSTASIS VALVE AND SYSTEM FOR
GUIDE CATHETER CONTROL" and U.S. Provisional Application No.
61/697,734, filed Sep. 6, 2012, entitled "HEMOSTASIS VALVE FOR
GUIDE CATHETER CONTROL", all of which are incorporated herein by
reference in their entireties.
BACKGROUND
[0002] The present invention relates generally to the field of
catheter systems for performing diagnostic and/or intervention
procedures. The present invention relates specifically to a
hemostasis valve for guide catheter control in robotic catheter
system.
[0003] Vascular disease, and in particular cardiovascular disease,
may be treated in a variety of ways. Surgery, such as cardiac
bypass surgery, is one method for treating cardiovascular disease.
However, under certain circumstances, vascular disease may be
treated with a catheter based intervention procedure, such as
angioplasty. Catheter based intervention procedures are generally
considered less invasive than surgery.
[0004] During one type of intervention procedure, a guide catheter
is inserted into a patient's femoral artery and positioned
proximate the coronary ostium of a patient's heart. A guide wire is
inserted into the guide catheter typically through a hemostasis
valve and maneuvered through the patient's arterial system until
the guide wire reaches the site of the lesion. A working catheter
is then moved along the guide wire until the working catheter such
as a balloon and stent are positioned proximate the lesion to open
a blockage to allow for an increased flow of blood proximate the
lesion. In addition to cardiovascular disease, other diseases may
be treated with catheterization procedures.
SUMMARY OF THE INVENTION
[0005] In another embodiment a system for the advancement or
retraction of a guide catheter has a base member, support, linear
actuator and bedside support. The base member has a hemostasis
valve affixed which includes a valve body with a first leg having a
proximal port, a distal port and a lumen with a linear axis
extending between the proximal port and the distal port. At least
one valve is located in the lumen adjacent the proximal port to
permit an interventional device to be passed therethrough. The
valve body has a second leg extending at an angle relative to the
first leg and has a lumen in fluid communication with the lumen of
the first leg. The support is affixed to the base member such that
it functions to move the base member and its affixed valve in
concert with the movement of the linear actuator along its linear
axis. The liner actuator to which the support is affixed has a
linear axis along which it may be advanced or retracted in a
continuous or incremental manner. The bedside support is slidingly
affixed to the linear actuator to allow the linear actuator to move
relative to the bedside support.
[0006] In another embodiment a system for the advancement or
retraction of a guide catheter has a base member, support, linear
actuator and bedside support. The base member is configured to have
a hemostasis valve affixed which includes a valve body with a first
leg having a proximal port, a distal port and a lumen with a linear
axis extending between the proximal port and the distal port. At
least one valve is located in the lumen adjacent the proximal port
to permit an interventional device to be passed therethrough. The
valve body has a second leg extending at an angle relative to the
first leg and has a lumen in fluid communication with the lumen of
the first leg. The support is affixed to the base member such that
it functions to move the base member and its affixed valve in
concert with the movement of the linear actuator along its linear
axis. The liner actuator to which the support is affixed has a
linear axis along which it may be advanced or retracted in a
continuous or incremental manner. The bedside support is slidingly
affixed to the linear actuator to allow the linear actuator to move
relative to the bedside support. The linear axis of the lumen of
the first leg of the hemostasis valve intersects the linear axis of
the linear actuator at an acute angle as measured from the vertex
that generally faces the support.
[0007] In another embodiment a method of adjusting the placement of
a guide catheter in the blood vessel of a human patient is provided
which involves providing a base member, a support, a linear
actuator, a bedside support, a hemostasis valve, a guide catheter,
a controller and a user input. The base member is configured to
have a hemostasis valve including a valve body with a first leg
having a proximal port, a distal port and a lumen with a linear
axis extending between the proximal port and the distal port, at
least one valve located in the lumen adjacent the proximal port to
permit an interventional device to be passed therethrough, and a
second leg extending at an angle relative to the first leg and
which has a lumen in fluid communication with the lumen of the
first leg affixed to it such that the distal port would be directed
toward a patient. The support is affixed to the base member. The
liner actuator that has a linear axis along which it may be
advanced or retracted in a continuous or incremental manner and is
affixed to the support in such a way that the support functions to
move the base member in concert with the movement of the linear
actuator along its linear axis. The bedside support is slidingly
affixed to the linear actuator to allow the linear actuator to move
relative to the bedside support. The hemostasis valve is affixed to
the base member and a guide catheter is affixed to the distal port
of the first leg of the hemostasis valve. The controller controls
the linear actuator and is provided with instructions from a user
input to advance or retract the linear actuator along its
longitudinal axis.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 is an isometric view of a hemostasis valve.
[0009] FIG. 2 is a schematic view of a robotic catheter control
system.
[0010] FIG. 3 is an isometric view of a catheter bedside
system.
[0011] FIG. 4 is an isometric view of a catheter bedside
system.
[0012] FIG. 5 is an isometric view of a hemostasis valve and guide
catheter drive mechanism
[0013] FIG. 6 is a cross-sectional view a hemostasis valve.
[0014] FIG. 7 is a top view of the catheter bedside system of FIG.
2.
[0015] FIG. 8 is a side view of the catheter bedside system of FIG.
2.
[0016] FIG. 9 is an isometric view of the guide catheter drive
mechanism and track.
[0017] FIG. 10 is a cross sectional view of the track.
[0018] FIG. 11 is a top schematic view of the hemostasis valve,
guide wire, working catheter, and guide catheter.
[0019] FIG. 12 is a rear isometric view of the catheter bedside
system.
[0020] FIG. 13 is an alternative hemostasis valve and guide
catheter drive mechanism.
[0021] FIG. 14 is a partial side view of the hemostasis valve and
guide catheter.
[0022] FIG. 15 is a partial side view of an alternative guide
catheter hub and guide catheter drive mechanism.
[0023] FIG. 16 is an isometric view of a quick release for a
hemostasis valve.
[0024] FIG. 17 is a cross sectional view of a portion of the quick
release of FIG. 16. in an engaged position.
[0025] FIG. 18 is a cross sectional view of a portion of the quick
release of FIG. 16. in a disengaged position.
[0026] FIG. 19 is an isometric view of an extension member
rotatably coupling a male rotating luer lock of a hemostasis valve
which is affixed to the base which carries a drive member.
[0027] FIG. 20 is an exploded view of the guide catheter, extension
member and hemostasis valve of FIG. 19.
[0028] FIG. 21 is a cross-sectional view of FIG. 19 taken generally
along line 21-21.
[0029] FIG. 22 is another embodiment of a friction drive member
driving an outer surface of a rotating male luer lock of the
hemostasis valve.
DETAILED DESCRIPTION OF THE EXAMPLE EMBODIMENTS
[0030] Referring to FIG. 1, a Y-connector or hemostasis valve 34
includes a valve body with a first leg 38 having a proximal port
adjacent a proximal end 42 and a distal port adjacent a distal end
40. First leg 38 includes lumen extending between the proximal end
42 and the distal end 40. A valve 162 is disposed adjacent proximal
end 42. A rotating luer connector 48 is rotatably secured to first
leg 38 proximate distal end 40. Rotating luer connector 48 includes
a member 56 configured to be rotatably driven by a drive mechanism
of a robotic catheter system 10.
[0031] Referring to FIG. 2, a robotic catheter system 10 includes a
bedside system 12, a work station 14 including a controller 16, a
user interface 18 and display 20. Bedside system 12 is located
adjacent a patient bed 22 and an imaging system 24. Imaging system
24 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.).
[0032] In one embodiment, imaging system 24 is a digital x-ray
imaging device that is in communication with workstation 14.
Imaging system 24 is configured to take x-ray images of the
appropriate area of patient during a particular procedure. For
example, imaging system 24 may be configured to take one or more
x-ray images of the heart to diagnose a heart condition. Imaging
system 24 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 14 to properly position a guide
wire, guide catheter, and a working catheter such as a stent during
a procedure. The image or images may be displayed on display 20 to
allow the user to accurately steer a distal tip of a guide wire or
working catheter into proper position. As used herein the direction
distal is used to refer to the direction closer to a patient in the
intended use of the component and the term proximal is used to
refer to the direction further away to a patient in the intended
use of the component.
[0033] Referring to FIG. 3 bedside system 12 includes a guide
catheter mechanism 26, a working catheter mechanism 28 and a guide
wire mechanism 30. In one embodiment, working catheter mechanism 28
and guide wire mechanism 30 are of the type described in U.S. Pat.
No. 7,887,549 entitled "Catheter System" which is incorporated
herein in its entirety.
[0034] Referring to FIGS. 3-5 guide catheter mechanism 26 includes
a base 32 configured to releasably receive a hemostasis valve 34
and a guide catheter rotational drive 36. Base 32 may include a
quick release mechanism to releasably secure hemostasis valve 34 to
base 32. One embodiment of a guide catheter quick release is
disclosed in US application publication U.S. 2012/0179032 entitled
"Remote Catheter System With Steerable Catheter" which is
incorporated herein in its entirety.
[0035] Hemostasis valve 34 includes a first leg 38 having a distal
end 40 and a proximal end 42. A second leg 44 extends from first
leg 38 and is in fluid communication with first leg 38 such that a
fluid may be introduced into a proximate end 46 of second leg 44.
Hemostasis valve first leg 38 defines a longitudinal axis 50
extending from proximal end 42 of first leg 38 to distal end 40 of
first leg 38.
[0036] The distal end 40 of first leg 38 includes a rotating luer
connector 48 that is rotatably coupled to distal end 40 of first
leg 38. Rotating luer connector 48 includes an external surface 52
and an internal region 54 having a luer female interface to
releasably couple a guide catheter. Luer connectors are known in
the art and provide a fluid tight connection between a guide
catheter and a hemostasis valve. Luer connectors are covered by
standards such as ISO 594 (including sections 594-1 and 594-2) and
EN 1707.
[0037] In one embodiment external surface 52 of rotating luer
connector 48 includes a gear 56 that is driven by rotational drive
36. Rotational drive 36 includes a drive gear 58 operatively
connected to a motor 60. Gear 56 may be integrally formed with
rotating luer connector 48 and coupled with a drive gear 58 for
rotational movement of the rotating connector.
[0038] In another embodiment, gear 56 may be secured to the outer
surface of rotational luer connector 48 such that gear 56 rotates
along with the rotation of rotational luer connector 48 about
longitudinal axis 50 of the first leg 38 of hemostasis valve
34.
[0039] Gears 56 and 58 may be beveled gears or miter gears to
provide direct rotation of driven gear 56 from a shaft rotated by
motor 60 and extending along an axis 62 perpendicular to
longitudinal axis 50 of first leg 38 of hemostasis valve 34.
Referring to FIG. 1, gear 56 is beveled such that gear teeth 64
extend in a direction toward proximal end 42 and away from distal
end 40 of first leg 38. Additionally, in one embodiment driven gear
56 is located a distance from distal end 40 to permit attachment
and removal of a guide catheter from rotational luer connector 48.
Drive gear 58 is positioned below first leg 38 to permit easy
removal of the hemostasis valve 34 from base 32.
[0040] Motor 60 may be secured to base 32, such that drive gear 58
is located above a first surface 66 of base 32 and motor 60 is
located below an opposing second surface 68 of base 32. First
surface 66 being closer to first leg 38 than second surface 68 of
base 32.
[0041] Referring to FIG. 1 FIG. 6 second leg 44 of hemostasis valve
34 has a longitudinal axis 70 extending longitudinally along second
leg 44 from proximate end 46 to a distal end 72 adjacent first leg
38. A second leg working plane is defined by axis 50 of first leg
38 and axis 70 of second leg 44. In one embodiment hemostasis valve
34 is secured to base 32 such that the second leg working plane is
not perpendicular to the horizontal as defined by gravity. Rather
the second leg working plane forms an acute angle with respect to a
vertical plane permitting an operator access to proximate end 46 of
second leg 44. In one embodiment second leg working plane may be
co-planer with a horizontal plane. As discussed above, hemostasis
valve 34 may be releasably coupled to base 32 with a quick release
that allows removal of hemostasis valve 34 from base 32.
[0042] Referring to FIG. 5, base 32 includes a raised wall 74
extending upwardly from and perpendicular to surface 66. Wall 74
extends in a direction parallel to axis 50 of hemostasis valve 34,
when hemostasis valve 34 is secured to base 32. Wall 74 is
proximate a rear portion 76 of base 32 and distal a front portion
78 of base 32. Gear 58 being intermediate wall 74 and front portion
78 of base 32. A guide member 80 is secured to wall 74 and extends
in a direction substantially parallel to axis 50 when hemostasis
valve 34 is secured to base 32. Guide member 80 has a guide portion
82 configured to direct a portion of a guide catheter prior to the
guide catheter entering a sleeve 84.
[0043] Referring to FIG. 3 and FIG. 10 a track 86 includes a
channel 88. A set screw 90 or other type of fastener extends
through track 86 into channel 88 to secure sleeve 84. In one
embodiment sleeve 84 includes a first wall 92 and a second wall 94
and a third wall 96 extending from first wall 92 forming a cavity
98. An opening 100 is defined as the space between the two free
ends of second wall 94 and third wall 96. In another embodiment,
sleeve 84 may be formed by a single arcuate wall member having an
opening 100. A disposable sterile barrier sleeve such as a plastic
sleeve may be located about track 86 such that when sleeve 84 is
isolated from track 86. Sleeve 84 may be a single use device and
disposed of once a medical procedure using the sleeve is complete.
In another embodiment, no sleeve 84 is placed into channel 88,
rather a sterile barrier may be placed within channel 88 to isolate
a guide catheter from the walls of channel 88. In an alternative
embodiment, no sleeve or sterile barrier is employed and track 86
is a single use device that is discarded after use and replaced
prior to the use of the bedside system with another patient or for
another procedure.
[0044] Referring to FIG. 7 and FIG. 8 track 86 includes a distal
end 102 that is configured to be located proximate a patient, and
an opposing proximal end 104. A track longitudinal axis 106 is
defined by the longitudinal axis of the track 86 extending between
proximal end 104 and distal end 102. In one embodiment track
longitudinal axis 106 and hemostasis valve longitudinal axis 50
form an acute angle 108. In one embodiment angle 108 is preferably
between 25 and 45 degrees, and more preferably between 30 and 45
degrees. In one embodiment angle 108 is 30 degrees.
[0045] In one embodiment plane track longitudinal axis 106 forms an
acute angle 112 with a horizontal plane defined by gravity that
also represents the horizontal plane of a bed or procedural surface
that a patient lies on. Track longitudinal axis 106 and hemostasis
valve first leg longitudinal axis 50 form a plane 110. In one
embodiment plane 110 is at an acute angle 108 with respect to the
horizontal plane. In other embodiments, the angle formed between
plane 110 and the horizontal may be an acute angle different than
the angle formed by track longitudinal axis 106 and the horizontal
plane.
[0046] Referring to FIGS. 7 and 8 guide catheter mechanism 26 is
offset to one side of track 86, as a result plane 110 is not
perpendicular to the horizontal plane. In one embodiment guide
catheter mechanism 26 is located closer to an operator than track
86. Stated another way, when an operator operates guide catheter
mechanism 26 the operator will be closer to the guide catheter
mechanism than the track.
[0047] Referring to FIG. 3, in one embodiment, track 86, guide
catheter mechanism 26 and cassette 118 may be rotated downwardly
about axis y such that guide catheter mechanism 26 and cassette 118
are easier to access by an operator facing guide catheter mechanism
26 and cassette 118. In one embodiment, the vector shown as x is
perpendicular to the longitudinal axis 106 extends through channel
88 and forms an angle 166 below a horizontal plane. In one
embodiment angle 166 is 15 degrees below a horizontal plane as
defined by gravity. In one embodiment an operator is located
proximate a first side a patient's bed. A support is located on one
side of the bed typically opposite the first side. The cassette 118
and guide catheter mechanism 26 is closer to the first side of the
patient's bed than track 86. In this way, the operator or physician
has easy access to the cassette 118 and guide catheter mechanism
26. By tilting the cassette 118 and guide catheter mechanism
downwardly toward the patient's bed such that the portion of the
cassette 118 and guide catheter mechanism 26 closer to track 86 is
higher vertically than the portion of the cassette 118 and guide
catheter mechanism 26 that is furthest from track 86. Additionally,
by pivoting guide catheter mechanism 26 and cassette 118 from the
longitudinal axis 106 by angle 108, the guide catheter mechanism
and cassette 118 is located in a position that allows for access by
the operator and/or physician.
[0048] Track 86 is secured to a bedside support 114 and is
maintained in a fixed position relative to patient bed 22. Bedside
support 114 may be secured directly to a side of patient bed 22 or
may be secured to a floor mounted support that is either fixed
relative patient bed 22 or positioned on a floor proximate patient
bed 22 such that track 86 is in a fixed location with respect to
patient bed 22 or to a patient on patient bed 22 during a catheter
based procedure. In one embodiment, the orientation of track 86 may
be adjusted with respect to patient bed 22 so that angle 112 may be
adjusted as well. In another embodiment angle 112 may be between
ten degrees and forty five degrees and in one embodiment angle 112
may be thirty degrees.
[0049] Referring to FIG. 12 guide catheter mechanism 26 may be
secured to a linear actuator 116 to translate guide catheter
mechanism along an axis parallel to or co-linear with track axis
106. The linear actuator 116 may provide for discrete incremental
movement or may provide for continuous movement. In one embodiment
the linear actuator includes a rack and pinion and in another
embodiment includes a robotic arm. Linear actuator 116 moves
independently of track 86. As discussed above working catheter
mechanism 28 and guide wire mechanism 30 may be included in a
cassette 118 that is operatively removably secured to a base member
120. Base member 120 and guide catheter mechanism 26 may be
operatively secured to linear actuator 116 with a support 164, such
that guide catheter mechanism 26, working catheter mechanism 28,
and guide wire mechanism 30 are translated together along a linear
axis.
[0050] The operation of the guide catheter mechanism 26 during a
catheter procedure will now be described using an exemplary
embodiment. A patient in need of a catheter based procedure will
lie in a supine position on patient bed 22. An opening in the
femoral artery will be prepared for the introduction of a guide
catheter 122.
[0051] Track 86 will be positioned relative to the patient such
that distal end 102 of track 86 is located proximate the femoral
artery of the patient. Track 86 is covered with a sterile barrier
and a single used sleeve 84 is positioned in channel 88. Typically
track 86 will be covered with a sterile barrier prior to
positioning relative to the patient. As sleeve 84 is positioned in
channel 88 the sterile barrier is placed into channel 88 such that
the sterile barrier provides a guard against any fluids that may be
exposed on sleeve 84 from contacting track 86. Sleeve 84 has a
distal end 124 and a proximal end 126. Distal end 124 of sleeve 84
is located proximal distal end 102 of track 86. In one embodiment,
sleeve 84 may have certain geometry to provide for placement within
channel 88 of track 86 and to facilitate entry and removal of a
portion of guide catheter 122.
[0052] In one catheter procedure on the heart of a patient, a guide
catheter 122 of appropriate length is selected based on the size of
the patient. Guide catheter 122 has a proximal end 128 and a distal
end 130. In one embodiment, proximal end 128 is first connected to
rotating luer connector 48 of hemostasis valve 34. Distal end 130
is then manually inserted into the femoral artery of the patient
and positioned such that distal end 130 of the guide catheter 122
is located adjacent the ostium of the heart. It is also
contemplated that proximal end 128 of guide catheter 122 may be
connected to rotating luer connector 48 after distal end 130 is
positioned adjacent the ostium.
[0053] Once guide catheter 122 is properly positioned relative to
the patient's heart, a central portion 132 of guide catheter 122
located outside of the patient is placed within sleeve 84 by
pushing a central portion 132 of guide catheter 122 through opening
100 into cavity 98.
[0054] Referring to FIG. 9 and FIG. 11, an entering portion 134 of
guide catheter 122 will be exposed between distal end 102 of track
86 and the patient. Additionally, a connecting portion 136 adjacent
proximal end 124 of guide catheter 122 extends outwardly from
sleeve 84 and track 86 in a direction toward guide catheter
mechanism 26. In one embodiment, connecting portion 136 has
sufficient length to allow for the guide catheter hub to be
connected to rotating luer 52 and have sufficient length to bend
into track 86. Connecting portion 136 extends outwardly from sleeve
84 at angle between approximately 25 to 45 degrees and 30 in but
may be between 30 and 45 degrees and may be 30 degrees. Guide
portion 82 guides guide catheter from support 80 into track 86.
Guide portion 82 may include a curved surface to assist in the
transition of the guide catheter into track 86.
[0055] Proximal end 128 guide catheter 122 is connected to rotating
luer connector 48. In one embodiment, proximal end 128 of guide
catheter 122 is connected to rotating luer connector 48 of
hemostasis valve 34 prior to distal end 124 of catheter 122 being
inserted into the patient or prior to central portion 132 being
positioned within sleeve 84. Hemostasis valve 34 is secured to base
32 with a quick release mechanism 138 such that driven gear 56 is
engaged with drive gear 58. Driven gear 56 located on external
surface 52 of rotating luer connector 48 is moved in a direction
toward drive gear 58 to engage driven gear 56 with drive gear 58.
Quick release 138 is then closed to releasably capture hemostasis
valve 34. In an engaged position proximal end 46 of second leg 44
of hemostasis valve extends away from track 86 and having a
horizontal vector component. Stated another way in a preferred
embodiment, second leg working plane defined by axis 50 of first
leg 38 and axis 70 of second leg 44 does not define a plane that is
perpendicular to a horizontal plane defined by gravity or by a
horizontal plane defined generally by the top surface of the
patient's bed 22.
[0056] Guide Catheter mechanism 26 is moved linearly by linear
actuator 116 to allow proper alignment of proximal end 126 of guide
catheter 122 with guide catheter mechanism 26. Guide catheters are
typically sold with varying lengths and selected depending on the
size of the patient. However, since the length of the guide
catheter required varies from patient to patient, it may be
necessary to adjust the position of the hemostasis valve quick
release for each patient. In one embodiment hemostasis valve quick
release may be adjusted along an axis parallel to track axis 106
relative to base 32. In another embodiment, base 32 may be moved
along an axis parallel to track axis 106 to properly position
hemostasis valve 34 so that guide catheter 122 is properly
positioned relative to the patient.
[0057] Linear adjustment of hemostasis valve along an axis parallel
to track axis 106 may be done manually or may be controlled by user
interface 18 at work station 14 that is typically remote from
bedside system 12. Work station 14 communicates with bedside system
through a wireless or wired connection. In this embodiment, an
operator manipulates user interface 18 such as a joy stick or touch
screen to provide a control signal to a linear actuator motor to
move base 32 relative to track 86.
[0058] Once guide catheter 32 is secured to hemostasis valve 34 and
hemostasis valve 34 is secured to base 34 with quick release 138 a
guide wire 140 and/or working catheter 142 is introduced into the
proximal end 42 of first leg 38. Proximal end 42 of first leg 38
includes a valve member 162 such as a Tuohy Borst adapter. Tuohy
Borst adapters are known in the art and operate to adjust the size
of the opening in proximal end 42 of first leg 38 of hemostasis
valve 34 to minimize the risk that fluids may exit the proximal end
42 of first leg 38. Other types of adapters known in the art may
also be used with hemostasis valve 34 to adjust the size of the
opening in proximal end 42 of first let 38.
[0059] During a catheter procedure it may be necessary to reseat
distal end 124 of guide catheter 122 within the ostium of the
patient. An operator may rotate guide catheter 122 by providing a
control signal to motor 60 to rotate drive gear 58 in a clockwise
or counterclockwise direction. As a result driven gear 56 rotates
causing rotation of rotating luer connector 48 and rotation of
guide catheter 122. In addition to a requirement to rotate guide
catheter 122 it may also be necessary during a catheter procedure
to move guide catheter 122 along track axis 106 to properly
position distal end 124 of guide catheter 122. Work station may
also include a user interface such as a joy stick, button, touch
screen or other user interface to control a linear actuator to move
guide catheter mechanism 26 in a direction substantially parallel
to track axis 106. Movement in a first direction in parallel to
track axis will result in movement of guide catheter 122 further
into the patient and movement of the linear translator in an
opposing second direction will result in movement of guide catheter
122 outwardly from the patient.
[0060] If an operator wishes to remove guide catheter 122, working
catheter 142 and/or guide wire 140 during a catheter procedure, the
operator releases quick release 138 and removes hemostasis valve 34
along with guide catheter 122 and working catheter 142 and/or guide
wire 140. Central portion 132 of guide catheter 122
[0061] Working catheter 142 and guide wire 140 may be removed from
their respective working catheter mechanism 28 and guide wire
mechanism 30 as described in U.S. Pat. 7,887,549. Once guide
catheter 122, 140 hemostasis valve 34, working catheter 142 and
guide wire 140 are removed from guide catheter mechanism 26,
working catheter mechanism 28 and guide wire mechanism 30 an
operator may manipulate guide catheter 122, working catheter 142
and guide wire 140 manually.
[0062] Referring to FIG. 13 an alternative embodiment of a drive
for rotational luer connector includes a motor 144 rotating a first
pulley 146 driving a belt 148 such as a timing belt. Belt 148 is
connected to the outer surface 150 of a pulley 152 about the outer
surface 150 of a rotational luer connector 156. First pulley 146
may include a plurality of teeth that mesh with ribs on belt 148
and the outer surface 150 of rotational luer connector 154 also
include a plurality of teeth that mesh with ribs on belt 148. In
this manner control of motor 144 allows for controlled rotation in
a clockwise and counterclockwise of rotational luer connector 156
thereby rotating guide catheter 122 attached thereto. In one
embodiment pulley 152 and bevel gear 56 are integrally formed with
the outer surface of rotating luer connector. However, it is also
contemplated that a collet having an outer surface defining a
pulley or bevel gear may be secured to the outer surface of
rotating luer connector.
[0063] Referring to FIG. 14, in another embodiment, a luer
extension member 158 may act to connect proximal end 128 of guide
catheter 122 to rotating luer connector 48. Luer extension member
158 may include an outer surface having a gear 160 or pulley member
to be operatively connected to the rotational drive motor 60 via
drive gear 58. In this embodiment, the rotational drive motor is
operatively coupled to the outer surface of luer extension member
and not directly to the outer surface of the rotating luer
connector. This permits the use of presently available commercially
available hemostasis valves. Additionally in a further embodiment a
luer extension member may include a rotating portion such that the
distal end of the hemostasis valve need not have a rotational luer
connector but rather include a non-rotational luer connector.
Extension 158 includes a female luer connector on the distal end to
removably receive a male luer fitting on a guide catheter.
Extension 158 also includes a male luer connector on the proximal
end that is removably received within a female luer connector of a
rotating connector on a Hemostasis valve. Note that in one
embodiment, gear 160 is a beveled gear with teeth facing the
proximal end.
[0064] Referring to FIG. 15 in another embodiment, a hub of guide
catheter 122 may have gear formed therewith or attached thereto to
connect to a rotating luer of hemostasis valve 34.
[0065] Referring to FIG. 19, an extension member 158 is interposed
between a Y-connector or hemostasis valve 34 and a guide catheter
22. This extension member 158 interacts with the drive gear 58, the
guide catheter 122 and the Y-connector or hemostasis valve 34 to
impart rotation to the guide catheter 122 while isolating the valve
34 from rotational motion such that the position of the second leg
44 of the valve 34 does not change position when the guide catheter
122 is rotated. The bracket 190 interacts with the groove 182 in
the extension member 158 to provide it support as it rotates and is
itself secured to either base 32 or wall 74. The valve 34 is
supported by bracket 192 that is itself secured to either base 32
or wall 74. The two brackets 190 and 192 provide stability to the
longitudinal axis 50 of the valve 34. The proximate end 128 of the
guide catheter 122 provides a luer interlock with the extension
member 158. Guide member 80 and track 86 provide support for the
guide catheter 122 as it extends in the distal direction away from
the extension member 158 and toward the patient bed 22 shown in
FIG. 2. The extension member 158 is provided with a beveled gear
face 160 which can be rotated by the drive gear 58 to impart
rotation to the guide catheter 122, although other means can be
used to impart rotation to the extension member 158, such as that
illustrated in FIG. 22. The drive gear 58 is in turn rotated by
motor 60.
[0066] Referring to FIG. 20, the extension member 158 may be
composed of an inner piece 170 and an outer piece 180. The inner
piece 170 has a male luer lock 172 that interacts with receptacle
129 on the guide catheter 128 to provide a fluid tight connection.
It also has a female luer lock that forms a rotational fluid tight
seal with protuberance 41 on the valve 40. Piece 170 is
frictionally captured by the bore of outer piece 180 that has a
collar 184 that helps to define the groove 182 that interacts with
the bracket 190. Outer piece 180 also carries the beveled gear face
160. The frictional capture of inner piece 170 is such that outer
piece 180 can readily transfer rotational motion to it.
Alternatively, inner piece 170 and outer piece 180 could be molded
as a single article.
[0067] Referring to FIG. 21, the composite structure of guide
catheter 122, extension member 158 and valve 34 is shown along
section line 21-21 of FIG. 19. The second leg 44 of the valve 34
has a proximal end 46, a distal end 72 and a longitudinal axis 70
Inner piece 170 is nested inside the bore of outer piece 180. Male
luer lock 172 engages the receptacle 129 at the proximal end 128 of
the guide catheter 122 while female luer lock 174 forms a fluid
tight rotational seal with the protuberance 41 on the distal end 40
of the valve 34. There is a continuous fluid path from the
proximate end 42 of the valve 34 to the bore of the guide catheter
122.
[0068] Referring to FIG. 22, an alternative extension member 159
can be used to impart rotational motion to the guide catheter 122
without carrying gear teeth. The drive gear 58 drives gear 160 that
frictionally engages the outer surface of the extension member 159
with an O-Ring 200. The gear 160 could carry any means of
frictional transfer to interact with the alternative extension
member 159. The extension member 159 has a male luer lock 174 that
engages the valve 34 to form a rotational seal.
[0069] Further modifications and alternative embodiments of various
aspects of the invention will be apparent to those skilled in the
art in view of this description. Accordingly, this description is
to be construed as illustrative only. The construction and
arrangements, shown in the various exemplary embodiments, are
illustrative only. Although only a few embodiments have been
described in detail in this disclosure, many modifications are
possible (e.g., variations in sizes, dimensions, structures, shapes
and proportions of the various elements, values of parameters,
mounting arrangements, use of materials, colors, orientations,
etc.) without materially departing from the novel teachings and
advantages of the subject matter described herein. Some elements
shown as integrally formed may be constructed of multiple parts or
elements, the position of elements may be reversed or otherwise
varied, and the nature or number of discrete elements or positions
may be altered or varied. The features described herein may be
combined in any combination and such combinations are contemplated.
The order or sequence of any process, logical algorithm, or method
steps may be varied or re- sequenced according to alternative
embodiments. Other substitutions, modifications, changes and
omissions may also be made in the design, operating conditions and
arrangement of the various exemplary embodiments without departing
from the scope of the present invention.
* * * * *