U.S. patent application number 15/801985 was filed with the patent office on 2018-05-03 for medical device positioner for remote catheter guidance systems.
The applicant listed for this patent is St. Jude Medical, Atrial Fibrillation Division, Inc.. Invention is credited to Mark B. Kirschenman, Eric S Olson.
Application Number | 20180116736 15/801985 |
Document ID | / |
Family ID | 50346123 |
Filed Date | 2018-05-03 |
United States Patent
Application |
20180116736 |
Kind Code |
A1 |
Olson; Eric S ; et
al. |
May 3, 2018 |
MEDICAL DEVICE POSITIONER FOR REMOTE CATHETER GUIDANCE SYSTEMS
Abstract
A medical device positioner for use with a remote catheter
guidance system (RCGS) is provided, which can address angular,
lateral and/or translational misalignment of an elongate medical
device between the RCGS and an access point on a patient's body.
Such a medical device positioner can include first and second tube
sections connected by a joint septum, with at least a portion of
the second tube section being adapted to be inserted into a
vascular system of a patient at an access point.
Inventors: |
Olson; Eric S; (Maplewood,
MN) ; Kirschenman; Mark B.; (Waverly, MN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
St. Jude Medical, Atrial Fibrillation Division, Inc. |
St. Paul |
MN |
US |
|
|
Family ID: |
50346123 |
Appl. No.: |
15/801985 |
Filed: |
November 2, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13790622 |
Mar 8, 2013 |
9827056 |
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15801985 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 39/10 20130101;
A61B 34/30 20160201; A61B 2034/301 20160201; A61M 2025/0175
20130101; A61B 2017/00477 20130101; A61M 25/0043 20130101 |
International
Class: |
A61M 25/00 20060101
A61M025/00; A61M 39/10 20060101 A61M039/10 |
Claims
1. A medical device positioner for use with a remote catheter
guidance system, the positioner comprising: a first elongate hollow
tube; a base connector attached to a proximal end of the first
elongate hollow tube, the base connector being configured to attach
to the remote catheter guidance system; a second elongate hollow
tube having a proximal end connected to a distal end of the first
elongate hollow tube, a portion of the second elongate hollow tube
being configured to be inserted into a vascular system of a patient
at an access point; a joint septum connecting the first elongate
hollow tube and the second elongate hollow tube; and a continuous
inner lumen inside the first and second elongate hollow tubes, the
inner lumen being configured to receive an elongate medical device
and allow axial movement of the elongate medical device through the
inner lumen.
2. The medical device positioner of claim 1, further comprising a
hemostasis valve positioned at the proximal end of the first
elongate hollow tube.
3. The medical device positioner of claim 1, wherein the first
elongate hollow tube is connected to the second elongate hollow
tube by insertion of the proximal end of the second elongate hollow
tube into the distal end of the first elongate hollow tube.
4. The medical device positioner of claim 1, wherein the first
elongate hollow tube is connected to the second elongate hollow
tube by insertion of the distal end of the first elongate hollow
tube into the proximal end of the second elongate hollow tube.
5. The medical device positioner of claim 1, further comprising an
annular suture ring disposed around and attached to the second
elongate hollow tube proximal to the portion adapted to be inserted
into a vascular system, the annular suture ring configured to be
secured to a patient's body at the access point.
6. The medical device positioner of claim 5, wherein the joint
septum is located next to the annular suture ring.
7. The medical device positioner of claim 5, wherein the joint
septum is located a distance proximally from the annular suture
ring.
8. The medical device positioner of claim 1, further comprising a
flexible jacket tube radially disposed around at least a portion of
the first elongate hollow tube.
9. The medical device positioner of claim 8, wherein the joint
septum is encompassed by the flexible jacket tube.
10. The medical device positioner of claim 8, wherein the flexible
jacket tube is constructed from one of: interlocking ball and
socket segmented tubing; spiral wound metal tubing; and skive cut
solid tubing.
11. The medical device positioner of claim 1, further comprising an
irrigation port located at the proximal end of the first elongate
hollow tube, the irrigation port configured to provide irrigation
to the inner lumen.
12. The medical device positioner of claim 1, wherein the elongate
medical device is one of a catheter, a fixed sheath and a
deflectable sheath.
13. An introducer for a catheter for use with a remote catheter
guidance system, the introducer comprising: a first hollow tube, at
least a portion of the first hollow tube being sized and configured
to be inserted into a vascular system of a patient at an access
point; an annular suture ring disposed around and attached to the
first hollow tube proximal to the portion adapted to be inserted
into a vascular system, the annular suture ring configured to be
secured to a patient's body at an access point; a second hollow
tube, the distal end of the second hollow tube axially connected to
the proximal end of the first hollow tube; a joint septum
connecting the first hollow tube and the second hollow tube; a
hemostasis valve attached to the proximal end of the second hollow
tube and configured to receive the catheter; attachment means
located on the proximal end of the second hollow tube for attaching
the introducer to the remote catheter guidance system; and a
flexible jacket tube radially disposed around at least a portion of
the second hollow tube; whereby the first hollow tube and second
hollow tube are configured to provide a guide for the catheter to
be inserted into the vascular system of a patient and the flexible
jacket tube is configured to align the catheter between the remote
catheter guidance system and an access point on a patient's body
before and during use of the remote catheter guidance system.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. patent application
Ser. No. 13/790,622, filed on Mar. 8, 2013, which is hereby
incorporated by reference in its entirety.
BACKGROUND
a. Field
[0002] The instant disclosure relates generally to guiding elements
for elongate medical devices used with remote catheter guidance
systems (RCGSs), and specifically to a positioner for guiding a
catheter during automated use of an RCGS.
b. Background Art
[0003] Electrophysiology (EP) catheters are used in a variety of
medical procedures, including, for example, diagnostic,
therapeutic, mapping and ablative procedures. Catheters are used to
correct conditions such as atrial arrhythmia, including for
example, ectopic atrial tachycardia, atrial fibrillation, and
atrial flutter. Typically, a catheter is manipulated through the
patient's vasculature to an intended site, for example, a site
within the patient's heart, and carries one or more electrodes,
which may be used for mapping, ablation, diagnosis, or other
treatments.
[0004] Advancing a catheter into a patient and to the intended site
generally requires a physician such as an electrophysiologist to
physically handle the catheter and move it into the patient. In a
conventional approach, an introducer is first inserted through the
skin surface at an access site on a patient's body and sutured to
the body to prevent motion relative to the patient. The
electrophysiologist then inserts a sheath for a catheter, or a
catheter alone, into the introducer opening at the access site and
threads it through the vasculature to a region of interest. The
sheath and/or catheter must be manually guided into the introducer
at the access site, which can include a hemostasis valve, at the
access point.
[0005] Recently, remote catheter guidance systems (RCGS) (or
robotically controlled medical device guidance systems) for one or
more medical devices have been used to facilitate precision control
of a medical device during a procedure. In general, these types of
systems carry out (as a mechanical surrogate) input commands of a
clinician or other end-user to deploy, navigate, and manipulate one
or more medical devices, such as, for example, a catheter and/or an
introducer or sheath for a catheter, or some other elongate medical
instrument. One exemplary remote catheter system is described and
depicted in U.S. patent application Ser. No. 12/347,811 (published
as United States patent application publication no. US 2009/0247993
A1) the entire disclosure of which is incorporated herein by
reference.
[0006] A conventional RCGS typically includes, among other
components, a manipulator assembly and one or more medical device
cartridges. Each medical device cartridge has a medical device
(e.g., a catheter or sheath) coupled therewith, and is configured
to be mounted on, or attached to, a corresponding manipulation base
of the manipulator assembly. When a medical device cartridge is
attached to the manipulation base, the manipulator assembly is
configured to maneuver the medical device associated with the
medical device cartridge by, for example, translating the device
cartridge back and forth in a linear fashion.
[0007] In addition to the increased precision control, another
benefit of an RCGS is that an electrophysiologist or other end-user
can operate the manipulation of a catheter through an input control
system while having access to a visualization system that displays,
for example, the location of the catheter. Such control system and
visualization system can be located at the patient site or at a
remote location.
[0008] The foregoing discussion is intended only to illustrate the
present field and should not be taken as a disavowal of claim
scope.
BRIEF SUMMARY
[0009] In various embodiments, a medical device positioner can be
provided for a remote catheter guidance system, the positioner
being configured to eliminate or minimize buckling of an elongate
medical device during automatic manipulation by the remote catheter
guidance system. One embodiment of such a medical device positioner
can include a base configured to attach to a remote catheter
guidance system and a first support member extending from the base.
The first support member can define a receiving portion that is
sized and configured to receive at least a portion of an elongate
medical device. The medical device positioner can include a second
support member that is movably coupled to the first support member
and also defines a second receiving area sized and configured to
receive at least a portion of the elongate medical device. The
medical device positioner can further include a hemostasis valve
positioned at the base.
[0010] In another embodiment, a medical device positioner can
include a base configured to attach to a remote catheter guidance
system and a substantially rigid first support member extending
from and pivotably attached to the base. The first support member
can define a receiving portion that is sized and configured to
receive at least a portion of an elongate medical device. The
medical device positioner can be attached to the base by means of a
ball and socket joint. A locking member radially disposed around
the first support member can also be included and the locking
member can be configured to secure at least a portion of an
elongate medical device in the receiving portion of the first
support member.
[0011] Another embodiment of a medical device positioner can
include a base configured to attach to a remote catheter guidance
system and a first support member extending from the base. The
first support member can include first and second tube sections, at
least a portion of the first tube section being adapted to be
inserted into a vascular system of a patient at an access point.
The second tube section can be located proximal to the first tube
section and there can be a joint septum connecting the first tube
section and the second tube section. The first and second tube
sections can be connected such that the proximal end of the second
tube section is inserted into the distal end of the first tube
section. Alternatively, the distal end of the first tube section
can be inserted into the proximal end of the second tube section.
The medical device positioner can also include an annular suture
ring attached to and around the first tube section and adapted to
be secured to a patient's body at an access point. A flexible
jacket tube can further be radially disposed around at least a
portion of the second tube section and can be constructed of, for
example, interlocking ball and socket segmented tubing, spiral
wound metal tubing or skive cut solid tubing. The medical device
positioner can further include an irrigation port located at the
proximal end of the second tube section.
[0012] Further embodiments to address the issues noted above are
also possible. For example, one embodiment includes a positioner
assembly for positioning an elongate medical device during use with
a remote catheter guidance system. The positioner assembly
comprises a positioner mount configured for attachment to the
remote catheter guidance system and a substantially rigid tube
pivotably attached to the positioner mount at the proximal end of
the rigid tube. The substantially rigid tube can be configured to
align the elongate medical device between the positioner mount and
an access point on a patient's body before and during use of the
remote catheter guidance system.
[0013] Another embodiment includes an introducer for a catheter for
use with a remote catheter guidance system. The introducer can
comprise first and second hollow tubes axially connected to each
other at a joint septum. A portion of the first hollow tube can be
adapted to be inserted into a vascular system of a patient at an
access point. An annular suture ring adapted to be secured to a
patient's body at an access point can be disposed around and
attached to the first hollow tube. The proximal end of the second
hollow tube can include a hemostasis valve for receiving a catheter
and means for attachment of the introducer to the remote catheter
guidance system. Further, a flexible jacket tube radially disposed
around at least a portion of the second hollow tube can be
included. The first and second hollow tubes provide a guide for the
catheter to be inserted into the vascular system of a patient,
while the flexible jacket tube is configured to align the catheter
between the remote catheter guidance system and an access point on
a patient's body before and during use of the remote catheter
guidance system.
[0014] The foregoing and other aspects, features, details,
utilities and advantages of the present disclosure will be apparent
from reading the following description and claims, and from
reviewing the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is an isometric diagrammatic view of a remote
catheter guidance system, illustrating an exemplary layout of
various system components.
[0016] FIG. 2 is a side view of an exemplary manipulator assembly
of the system illustrated in FIG. 1 coupled to a robotic support
structure.
[0017] FIG. 3 is an isometric view of another exemplary manipulator
assembly of the system illustrated in FIG. 1, including one
embodiment of a medical device positioner attached thereto.
[0018] FIG. 4 is an expanded view of one end of the exemplary
manipulator assembly of FIG. 3 and the attached medical device
positioner.
[0019] FIG. 5 is an isometric view of the medical device positioner
of FIG. 4, shown in an open and partially-extended position.
[0020] FIGS. 6a-6d are isometric views of the components of the
embodiment of a medical device positioner illustrated in FIG.
5.
[0021] FIG. 7a is an isometric view of the medical device
positioner illustrated in FIG. 5, shown in a closed and
fully-extended position.
[0022] FIG. 7b is an expanded view of a portion of the medical
device positioner illustrated in FIG. 7a, showing a locking
mechanism.
[0023] FIG. 7c is a view of the underside of the medical device
positioner illustrated in FIG. 7a.
[0024] FIG. 8 is an isometric view of another embodiment of a
medical device positioner, shown in an open position.
[0025] FIG. 9 is an isometric view of another embodiment of a
positioner mount for a medical device positioner.
[0026] FIG. 10 is an isometric view of the exemplary manipulator
assembly illustrated in FIG. 2, with another embodiment of a
medical device positioner attached thereto.
[0027] FIG. 11a is an isometric view of the medical device
positioner of FIG. 10.
[0028] FIG. 11b is a top view of the medical device positioner of
FIG. 11a.
[0029] FIG. 12 is a cross-sectional view along cut line A-A of the
medical device positioner of FIG. 11b.
[0030] FIG. 13a is an isometric view of another embodiment of a
medical device positioner.
[0031] FIG. 13b is a top view of the medical device positioner of
FIG. 13a.
[0032] FIG. 14 is a cross-sectional view along cut line B-B of the
medical device positioner of FIG. 13b.
DETAILED DESCRIPTION
[0033] Various embodiments are described herein to various
apparatuses. Numerous specific details are set forth to provide a
thorough understanding of the overall structure, function,
manufacture, and use of the embodiments as described in the
specification and illustrated in the accompanying drawings. It will
be understood by those skilled in the art, however, that the
embodiments may be practiced without such specific details. In
other instances, well-known operations, components, and elements
have not been described in detail so as not to obscure the
embodiments described in the specification. Those of ordinary skill
in the art will understand that the embodiments described and
illustrated herein are non-limiting examples, and thus it can be
appreciated that the specific structural and functional details
disclosed herein may be representative and do not necessarily limit
the scope of the embodiments, the scope of which is defined solely
by the appended claims.
[0034] Reference throughout the specification to "various
embodiments," "some embodiments," "one embodiment," or "an
embodiment," or the like, means that a particular feature,
structure, or characteristic described in connection with the
embodiment is included in at least one embodiment. Thus,
appearances of the phrases "in various embodiments," "in some
embodiments," "in one embodiment," or "in an embodiment," or the
like, in places throughout the specification are not necessarily
all referring to the same embodiment. Furthermore, the particular
features, structures, or characteristics may be combined in any
suitable manner in one or more embodiments. Thus, the particular
features, structures, or characteristics illustrated or described
in connection with one embodiment may be combined, in whole or in
part, with the features, structures, or characteristics of one or
more other embodiments without limitation given that such
combination is not illogical or non-functional.
[0035] It will be appreciated that the terms "proximal" and
"distal" may be used throughout the specification with reference to
a remote catheter guidance system manipulating one end of medical
device used to treat a patient. The term "proximal" refers to the
portion of the instrument closest to the remote catheter guidance
system and the term "distal" refers to the portion located furthest
from the remote catheter guidance system. It will be further
appreciated that for conciseness and clarity, spatial terms such as
"vertical," "horizontal," "up," "down," "top" and "bottom" may be
used herein with respect to the illustrated embodiments. However,
surgical instruments may be used in many orientations and
positions, and these terms are not intended to be limiting and
absolute.
[0036] Referring now to the drawings wherein like reference
numerals are used to identify the same or substantially similar
components in the various views, FIG. 1 illustrates one exemplary
embodiment of a remote catheter guidance system 10 (RCGS 10) for
manipulating one or more medical devices. The RCGS 10 can be used,
for example, to manipulate the location and orientation of
catheters and sheaths in a heart chamber or in another body cavity
or lumen. The RCGS 10 thus provides the user with a similar type of
control provided by a conventional manually-operated system, but
allows for repeatable, precise, and dynamic movements. For example,
a user such as a physician or electrophysiologist can identify
locations (potentially forming a path) on a rendered computer model
of the cardiac anatomy. The system can be configured to relate
those digitally selected points to positions within a patient's
actual/physical anatomy, and can thereafter command and control the
movement of the sheath and/or catheter to the defined positions.
Once at a specified target position, either the user or the system
can perform the desired diagnostic or therapeutic function. The
RCGS 10 can enable full robotic navigation/guidance and
control.
[0037] As shown in FIG. 1, the RCGS 10 can generally include one or
more monitors or displays 12, a visualization, mapping, and/or
navigation system 14, a human input device and control system
(referred to as "input control system") 100, an electronic control
system 200, a manipulator assembly 300 for operating one or more
device cartridges 400, and a manipulator support structure 500 for
positioning the manipulator assembly 300 in proximity to a patient
or a patient's bed.
[0038] The visualization, navigation, and/or mapping system 14 may
be configured to provide a number of advanced features, such as
visualization, mapping, navigation support and positioning (i.e.,
determine a position and orientation (P&O) of a sensor-equipped
medical device, for example, a P&O of a distal tip portion of a
catheter). In an exemplary embodiment, the system 14 may comprise
an impedance-based system, such as, for example, the EnSite.TM.
NavX.TM. system commercially available from St. Jude Medical, Inc.,
and as generally disclosed in U.S. Pat. No. 7,263,397" the entire
disclosure of which is incorporated herein by reference. In other
exemplary embodiments, however, the system 14 may comprise other
types of systems, such as, for example and without limitation: a
magnetic-field based system such as the Carto.TM. System available
from Biosense Webster, Inc., and as generally shown with reference
to one or more of U.S. Pat. Nos. 6,498,944, 6,788,967, and
6,690,963, the entire disclosures of which are incorporated herein
by reference, or the MediGuide.TM. Technology system available from
St. Jude Medical, Inc., and as generally shown with reference to
one or more of U.S. Pat. Nos. 6,233,476, 7,197,354, and 7,386,339,
the entire disclosures of which are incorporated herein by
reference; and a combination impedance-based and magnetic
field-based system such as the Carto 3 System also available from
Biosense Webster, Inc.
[0039] The input control system 100 may be configured to allow a
user, such as an electrophysiologist, to interact with the RCGS 10,
in order to control the movement and advancement/withdrawal of one
or more medical devices, such as, for example, a catheter and/or a
fixed sheath and/or a deflectable sheath (see, e.g., U.S. Patent
Publication No. 2010/0256558, and PCT/US2009/038597, published as
WO 2009/120982, the entire disclosures of which are incorporated
herein by reference). Generally, several types of input devices and
related controls can be employed, including, without limitation,
instrumented traditional catheter/sheath handle controls, oversized
catheter/sheath models, instrumented user-wearable gloves, touch
screen display monitors, 2-D input devices, 3-D input devices,
spatially detected styluses, and traditional joysticks. For a
further description of exemplary input apparatus and related
controls, see, for example, U.S. Patent Publication Nos.
2011/0015569 and 2009/0248042, the entire disclosures of which are
incorporated herein by reference. The input devices can be
configured to directly control the movement of the catheter and
sheath, or can be configured, for example, to manipulate a target
or cursor on an associated display.
[0040] The electronic control system 200 can be configured to
translate (i.e., interpret) inputs (e.g., motions) of the user at
an input device of the input control system 100 (or from another
source) into a resulting movement of one or more medical devices
(e.g., a catheter and/or a sheath). In this regard, the system 200
may include a programmed electronic control unit (ECU) in
communication with a memory or other computer readable media
(memory) suitable for information storage. It should be understood
that although the visualization, navigation, and/or mapping system
14 and the electronic control system 200 are shown separately in
FIG. 1, integration of one or more computing functions can result
in a system including an ECU on which can be run both (i) various
control and diagnostic logic pertaining to the RCGS 10 and (ii) the
visualization, navigation, and/or mapping functionality of system
14.
[0041] The manipulator assembly 300, in response to commands issued
by the electronic control system 200, can be configured to maneuver
the medical device(s) associated therewith (e.g., translation
movement, such as advancement and withdrawal of the medical
device(s)), as well as to effectuate distal end (tip) deflection
and/or rotation or virtual rotation. In an embodiment, the
manipulator assembly 300 can include actuation mechanisms/units
(e.g., a plurality of electric motor and lead screw combinations,
or other electric motor configurations) for linearly actuating one
or more control members (e.g., steering wires) associated with the
medical device(s) for achieving the above-described translation,
deflection and/or rotation (or virtual rotation). Further details
of a manipulator assembly can be found in U.S. Patent Publication
No. 2009/0247942, the entire disclosure of which is incorporated
herein by reference.
[0042] A device cartridge 400 can be provided for each medical
device controlled by the RCGS 10. For this exemplary description of
an RCGS, and as will be described in greater detail below, one
cartridge may be associated with a catheter and a second cartridge
may be associated with an outer sheath. However, in other exemplary
embodiments, a single medical device, and therefore, a single
cartridge, or more than two medical devices, and therefore, more
than two cartridges, may be used. Accordingly, embodiments wherein
more or less than two cartridges are employed remain within the
spirit and scope of the present disclosure. Furthermore, medical
device form factors other than cartridges 400 may be used with the
manipulation assembly 300. In any event, the cartridges (or other
medical device form factor) may be coupled, generally speaking, to
the RCGS 10 to allow for robotically-controlled movement. Further
details of a device cartridge can be found in U.S. Patent
Publication Nos. 2009/0247943 and 2009/0247944, the entire
disclosures of which are incorporated herein by reference.
[0043] FIG. 2 is a side view of an exemplary manipulator support
structure 500 (see U.S. Patent Publication No. 2009/0247944, the
entire disclosure of which was incorporated by reference above) for
supporting the manipulator assembly 300. The structure 500 can
generally include a support frame 502 including retractable wheels
504 and attachment assembly 506 for attachment to an operating bed
(not shown). A plurality of support linkages 508 can be provided
for accurately positioning one or more manipulator assemblies, such
as the manipulator assembly 300.
[0044] FIG. 3 is an illustration of one embodiment of the
manipulator assembly 300. With reference to FIGS. 2 and 3, the
manipulator assembly 300 includes a housing 302 and is configured
to serve, for example, as the interface for the mechanical control
of the movements or actions of one or more device cartridges, such
as catheter and sheath cartridges 402, 404. Each device cartridge
is configured to receive and retain a respective proximal end of an
associated medical device, for example catheter 406 and sheath 408.
The assembly 300 also includes one or more plurality of
manipulation bases (not shown) onto which the device cartridges are
mounted or attached. After mounting, the manipulator assembly 300,
through the manipulation bases, is capable of manipulating the
attached catheter and/or sheath.
[0045] In the illustrated embodiment of FIGS. 2 and 3, the catheter
and sheath cartridges 402, 404 are aligned with each other such
that catheter 406 can pass through sheath 408 in a coaxial
arrangement. Thus, sheath 408 can include a water-tight proximal
sheath opening 410 sized to receive the catheter 406 and to let the
catheter 406 pass therethrough. Overall, the manipulator assembly
300 is configured to allow not only coordinated movement but also
relative movement between catheter and sheath cartridges 402, 404
(and thus relative movement between catheter and sheath). The
manipulator assembly 300 of FIG. 3 is shown having only the sheath
408 attached to cartridge 404, but it should be understood that a
catheter 406 may be attached to cartridge 402, and inserted into
sheath 408 as shown in FIG. 2.
[0046] FIG. 4 illustrates the distal end of the manipulator
assembly 300, shown with sheath cartridge 404 and sheath 408,
simulating the insertion of sheath 408 into a patient's body. In a
typical use of an RCGS 10 for manipulation of a sheath 408 and
catheter 406, a conventional introducer 412 is first inserted into
the vasculature system of a patient. The sheath 408 (with catheter
406 inserted in sheath 408), is then inserted into the introducer
opening 414 and manually advanced to the desired general location
in the patient. The introducer 412 can further include an
irrigation port 413. The sheath 408 can then be manipulated by the
RCGS 10 through the manipulator assembly 300.
[0047] Angular, lateral or translational misalignment of the sheath
408 and the introducer opening 406 can result in increased friction
between the sheath 408 and the introducer opening 414 during
manipulation by the RCGS 10. The increased friction can cause the
sheath 408 to buckle or bind, potentially leading to the failure of
the sheath 408 or tearing of tissue at the site of the introducer
opening 414. Prior RCGS systems are susceptible to such
misalignment problems due to the fixed nature of both the sheath
cartridge 404, which holds the proximal end of the sheath 408, and
the patient, as well as the distance between any support for the
sheath 408 and the introducer opening 414. The risk that the sheath
408 may buckle can necessitate the presence of a physician or other
user during the procedure to manually guide the sheath 408 if
buckling does occur.
[0048] An embodiment of a medical device positioner to reduce or
eliminate the described problems is shown in FIG. 4. Positioner 416
provides support and direction to the sheath 408 (with or without
catheter 406 within it) between the cartridge 404 and the
introducer opening 414. The positioner 416 is pivotally mounted to
the manipulator assembly 300, allowing the sheath 408 to be better
aligned with the introducer opening 414. The positioner further
provides support for the sheath 408 at a distance substantially
closer to the introducer opening 414. These and other features help
reduce the amount of friction between the sheath 408 and introducer
opening 414, thus decreasing the risk of buckling to the sheath
408.
[0049] Shown in greater detail in FIGS. 5 and 6a-6d, positioner 416
consists of a positioner mount 418 for attachment to the
manipulator assembly 300, a barrel 420, a locking tube 422, a
support 424 and a barrel tip 426.
[0050] Barrel 420 consists of a tube portion 428 and a ball end
430. A slot 432 is located along the entire length of the barrel
420, through tube portion 428 and ball end 430. The slot 432 is
sized to accommodate a sheath 408 and/or catheter 406. Shoulder 433
is located between the tube portion 428 and ball end 430. An
orientation pin 434 can be located on the ball end 430, opposite
the slot 432. Attached at the end of the tube portion 428 opposite
the ball end 430 is barrel tip 426, which provides a tapered
opening for the slot 432 at the end of tube portion 428.
[0051] Positioner mount 418 includes socket 436, configured to
engage ball end 430 of barrel 420, creating a ball joint. As is
evident from the illustration in FIG. 5, the ball joint allows
barrel 420 to pivot about the socket 436 in both the y-axis and
z-axis directions, while also allowing it to rotate about the
x-axis. The size and shape of the socket 436 can be configured to
restrict the range of motion of the barrel 420 in the y-axis
direction. In the embodiment shown, positioner mount 418 further
includes orientation slot 438 which engages orientation pin 434 on
ball end 430 of barrel 420. When pin 434 is engaged in orientation
slot 438, the range of motion of barrel 420 in the z-axis direction
is limited and the ability of barrel 420 to rotate about the x-axis
is substantially restricted. The allowable range of motion of
barrel 420 in both the y-axis and the z-axis, and thus the
configuration of socket 436 and orientation slot 438, may depend on
the desired or allowable bending radius of sheath 408 and/or
catheter 406.
[0052] Positioner mount 418 further includes guide 440 configured
to engage and contain sheath 408. Socket 436 also includes guide
slot 437 which allows sheath 408 to pass from guide 440 to the slot
432 in barrel 420. The positioner mount 418 is attached to
manipulator assembly 300 through mounting clips 442, 444, located
on the positioner mount 418 opposite socket 436. The mounting clips
442, 444 engage mounting slots (not shown) in housing 302 of
manipulator assembly 300.
[0053] Continuing to refer to FIGS. 5 and 6a-6d, in an embodiment,
locking tube 422 is a hollow tube configured to be rotatably fitted
around the tube portion 428 of barrel 420. Locking tube 422
consists of a shaft 452 and a grip portion 454 that is designed to
facilitate a user manually rotating the tube lock 422 about the
tube portion 428. Locking tube 422 is secured on barrel 420 by the
shoulder 433 at one end and by barrel tip 426 at the other end of
the tube portion 428. A slot 453 is located on one side of locking
tube 422 along its entire axial length. The slot 453 is
substantially the same size as barrel slot 432 and is configured to
facilitate placement of the sheath 408 into the barrel 420 when
slot 453 is aligned with barrel slot 432.
[0054] Support 424 is an elongate member designed to provide
additional support to the sheath 408 at a distance distally beyond
the distal end of barrel 420. Support 424 consists at one end of
tube tabs 446, 447 sized to substantially surround locking tube
shaft 452 and capable of sliding or telescoping along locking tube
shaft 452 in an axial direction. At the other end of support 424 is
support guide 448 sized to hold sheath 408 while allowing it to
slide in an axial direction. Between tube tabs 446, 447 and support
guide 448 is support shaft 449 having a concave inside surface
which engages the outer surface of the locking tube shaft 452.
Support 424 may allow rotational movement of the locking tube 422
relative to the support 424. In another embodiment, support 424 is
configured with a lock tab 451 along the length of its internal
surface that engages a lock slot 455 located along the length of
the outer surface of the locking tube 422 opposite slot 453. When
lock tab 451 is engaged with lock slot 455 movement of the support
424 relative to the locking tube 422 is inhibited.
[0055] FIG. 5 illustrates the positioner 416 in an open position,
allowing for the placement of the sheath 408 into the positioner
416. In FIGS. 4 and 7a-7c the positioner 416 is shown in a closed
position (sheath 408 is not shown in FIGS. 7a-7c). In operation,
the positioner 416 is placed in the open position, with the locking
tube slot 451 aligned with the barrel slot 432. Ball end 430 of
barrel 420 is fitted into the socket 436 of positioner mount 418.
The sheath 408, with or without the catheter 406 inserted, is then
placed into the barrel slot 432 and snapped into support guide 448
and mount guide 440. The locking tube 422 can then be rotated about
barrel 420 ensuring that barrel slot 432 is covered by locking tube
shaft 452. FIG. 7c shows the underside of positioner 416 of FIG.
7a, with support 424 not shown. The underside view shows the
locking tube slot 453 rotated 180.degree. from barrel slot 432 when
in the locked position. In other embodiments, the locking tube 422
may be rotated less than 180.degree. about the barrel tube portion
428.
[0056] In the embodiment of FIG. 7b, locking tube 422 is secured in
a locked position by a locking detent 456, which engages the barrel
slot 432. Other mechanisms can be used to secure movement of
locking tube 422 relative to barrel 420. Once the sheath 408 is
secured in the positioner 416, the positioner mount 418 can be
locked into place on the manipulator assembly 300 with mounting
clips 442, 444. Alternatively, the positioner mount 418 can be
attached to the manipulator assembly 300 before ball end 430 is
fitted into socket 436 and/or before the sheath 408 is inserted
into barrel slot 432. Additionally, the sheath 408 may be inserted
into the introducer opening 414 before or after being fitted into
the positioner 416.
[0057] During operation of the positioner 416 as described in the
preceding embodiments, it is evident that the positioner 416 is in
contact with the sheath 408 or other medical device being guided
into a patient. Thus, the positioner 416 must be sterile prior to
use in a procedure. In an embodiment, the components of the
positioner 416 may be constructed of a disposable, lightweight
sterilized plastic using injection molding techniques. In another
embodiment, the components of the positioner 416 may be constructed
of reusable materials (such as stainless steel) which can be
re-sterilized for repeated use.
[0058] FIG. 8 is another embodiment of a positioner 516, in which
the positioner mount 418 is the same as in positioner 416. In the
illustrated embodiment, locking tube 522 is comprised entirely of
grip portion 554. All other aspects of positioner 16 are
substantially similar to positioner 416.
[0059] FIG. 9 illustrates another embodiment of a positioner mount
618 for use in the positioner 416 with all other components being
the same. Alternative positioner mount 618 is similar to positioner
mount 418 as it includes socket 636 for engaging ball end 430 of
barrel 420 and guide slot 637 allowing sheath 408 to access slot
432 in barrel 420. Positioner mount 618 further includes mounting
clips 642, 644 for attaching to housing 302 of manipulator assembly
300.
[0060] In the above described embodiments, misalignment of an
elongate medical device between a manipulator assembly of an RCGS
and an access point on a patient's body is addressed by a
positioner configured to pivot about a point on a distal end of the
manipulator assembly and to provide support at a distance between
the manipulator assembly and the access point. The described
positioner guides an elongate medical device from the manipulation
assembly to a patient, in spite of angular, lateral, or distance
misalignment. The positioner further allows a procedure to be set
up and removed without hindrance.
[0061] An alternative embodiment of a device to address the
identified misalignment problems is illustrated in FIGS. 10-12.
FIG. 10 shows a catheter guide 711 attached to housing 302 of
manipulation assembly 300. FIG. 11a is an isometric view of the
catheter guide 711 while FIG. 11b shows a top view of the catheter
guide 711. In this embodiment, catheter guide 711 comprises an
elongate introducer, or vascular guide section 713 at its distal
end, a proximal section 714, a transition section 715 between the
vascular guide section 713 and proximal section 714, and an inner
lumen 712 extending through the length of the catheter guide 711.
An annular stop ring 716 is located between the vascular guide
section 713 and the transition section 715. During a procedure, the
vascular guide section 713 is inserted into the vasculature of a
patient. The annular stop ring 716 is then sutured to the patient's
body, thus restricting internal vascular disturbance during setup
of the procedure and during use.
[0062] A hemostasis valve 718 is provided at the proximal section
714 of catheter guide 711 for receiving sheath 408 from cartridge
404. An irrigation port 719 is also located at the proximal section
714 to provide irrigation to the inner lumen 712 of the catheter
guide 711. The proximal section 714 further includes an attachment
area 720 configured to be attached to mounting clip 722, which
provides a means for attachment of the catheter guide 711 to
manipulator assembly 300. Mounting clip 722 can be permanently or
releasably attached to the manipulator assembly 300.
[0063] FIG. 12 shows a cross-sectional view of catheter guide 711
along line A-A shown in FIG. 11b. As shown, vascular guide section
713 comprises an elongate tube 724 which extends the length of
vascular guide section 713 and extends beyond the annular stop ring
716. Annular stop ring 716 is fixed to elongate tube 724 to provide
a fixed length internal to a patient. Transition section 715
comprises a semi-ridged positioning jacket 726 along the length of
transition section 715 between the suture ring 716 and the proximal
section 714. Transition section 715 further comprises an elongate
tube 728 extending from the hemostasis valve 718 through the
positioning jacket 726 to a point proximal of the distal end of the
transition section 715 and the suture ring 716. Located at the
distal end of elongate tube 728, and contained within positioning
jacket 726, is a joint septum 730 configured to receive the
proximal end of elongate tube 724. In use, when the proximal end of
elongate tube 724 is inserted into joint septum 730, a portion of
elongate tube 724 is inserted into the distal end of elongate tube
728.
[0064] The positioning jacket 726 provides flexibility and support
to the catheter guide 711 allowing for variances in the distance
and alignment between the hemostasis valve 718 (i.e., the catheter
introduction point) and the annular stop ring 716 (i.e., the patent
access point). To facilitate its flexibility, positioning jacket
726 may be constructed of various known types of adjustable tubing,
such as corrugated tubing, interlocking ball and socket segmented
tubing, spiral wound metal tubing and skive cut solid tubing.
[0065] Another embodiment of a catheter guide 711' is illustrated
in FIGS. 13a, 13b and 14, with most of the components being the
same as in catheter guide 711. In catheter guide 711', a joint
septum 732 is located at the proximal end of elongate tube 724' of
vascular guide section 713. Elongate tube 724' thus does not extend
into transition section 715. Rather, elongate tube 728' extends
beyond the distal end of positioning jacket 726 and, in use, is
inserted into joint septum 732. A portion of elongate tube 728'
thus extends into elongate tube 724'. In this embodiment, it is
evident that the elongate tube 724' of the vascular guide section
713 must have a larger inner diameter than the outer diameter of
elongate tube 728', while in the embodiment of FIG. 12, the outer
diameter of elongate tube 724 is smaller than the inner diameter of
elongate tube 728.
[0066] Although numerous embodiments of this disclosure have been
described above with a certain degree of particularity, those
skilled in the art could make numerous alterations to the disclosed
embodiments without departing from the spirit or scope of this
disclosure. All directional references (e.g., plus, minus, upper,
lower, upward, downward, left, right, leftward, rightward, top,
bottom, above, below, vertical, horizontal, clockwise, and
counterclockwise) are only used for identification purposes to aid
the reader's understanding of the present embodiments, and do not
create limitations, particularly as to the position, orientation,
or use of the embodiments. Joinder references (e.g., attached,
coupled, connected, and the like) are to be construed broadly and
may include intermediate members between a connection of elements
and relative movement between elements. As such, joinder references
do not necessarily infer that two elements are directly connected
and in fixed relation to each other. It is intended that all matter
contained in the above description or shown in the accompanying
drawings shall be interpreted as illustrative only and not
limiting. Changes in detail or structure may be made without
departing from the spirit of the disclosure as defined in the
appended claims.
[0067] Any patent, publication, or other disclosure material, in
whole or in part, that is said to be incorporated by reference
herein is incorporated herein only to the extent that the
incorporated materials does not conflict with existing definitions,
statements, or other disclosure material set forth in this
disclosure. As such, and to the extent necessary, the disclosure as
explicitly set forth herein supersedes any conflicting material
incorporated herein by reference. Any material, or portion thereof,
that is said to be incorporated by reference herein, but which
conflicts with existing definitions, statements, or other
disclosure material set forth herein will only be incorporated to
the extent that no conflict arises between that incorporated
material and the existing disclosure material.
* * * * *