U.S. patent application number 12/192950 was filed with the patent office on 2009-05-21 for variable stiffness guidewire systems.
This patent application is currently assigned to WRIGHT-AHN TECHNOLOGIES, LLC. Invention is credited to Sam Seunghae Ahn, Jay Ralph Wright.
Application Number | 20090131912 12/192950 |
Document ID | / |
Family ID | 40642725 |
Filed Date | 2009-05-21 |
United States Patent
Application |
20090131912 |
Kind Code |
A1 |
Wright; Jay Ralph ; et
al. |
May 21, 2009 |
Variable Stiffness Guidewire Systems
Abstract
A variable-stiffness guidewire system comprises an elongated
flexible guidewire having a body and a guidewire head that is
coupled to the body. The guidewire head is slidably moveable with
respect to a guidewire collar of the body to adjust a stiffness of
at least a portion of the guidewire. An insert is coupled to the
guidewire and positioned between the guidewire head and the
guidewire collar. The insert has a cross-sectional dimension no
larger than a diameter of the body. The insert is configured to
maintain a distance of the guidewire head from the guidewire collar
to maintain a desired stiffness in the at least a portion of the
guidewire.
Inventors: |
Wright; Jay Ralph;
(Temecula, CA) ; Ahn; Sam Seunghae; (Dallas,
TX) |
Correspondence
Address: |
Nixon Peabody LLP
200 Page Mill Road
Palo Alto
CA
94306
US
|
Assignee: |
WRIGHT-AHN TECHNOLOGIES,
LLC
Los Angeles
CA
|
Family ID: |
40642725 |
Appl. No.: |
12/192950 |
Filed: |
August 15, 2008 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61003404 |
Nov 15, 2007 |
|
|
|
61005745 |
Dec 7, 2007 |
|
|
|
Current U.S.
Class: |
604/524 |
Current CPC
Class: |
A61M 2025/0915 20130101;
A61M 25/09 20130101; A61M 2025/09116 20130101 |
Class at
Publication: |
604/524 |
International
Class: |
A61M 25/09 20060101
A61M025/09 |
Claims
1. A variable-stiffness guidewire system comprising: an elongated
flexible guidewire having a body and a guidewire head coupled to
the body, the guidewire including a guidewire collar proximal to
the guidewire head, the guidewire head slidably moveable with
respect to the guidewire collar of the body via a tensioning wire
to adjust a stiffness of at least a portion of the guidewire; and
an insert coupled to the guidewire and positioned between the
guidewire head and the guidewire collar, the insert having a
cross-sectional dimension no larger than a diameter of the body,
the insert configured to maintain a distance of the guidewire head
from the guidewire collar to maintain a desired stiffness in the at
least a portion of the guidewire.
2. The system of claim 1, wherein the insert further comprises a
cylindrical body having a first end and a second end opposite from
the first end, wherein the first end abuts the guidewire head and
the second end abuts the guidewire collar.
3. The system of claim 2, wherein the cylindrical body further
comprises an aperture running through the body between the first
and second ends, wherein at least a portion of the aperture is
configured to receive a tensioning wire of the guidewire
therein.
4. The system of claim 3, wherein the cylindrical body further
comprises a plurality of opposing faces adjacent to the aperture,
each face extending between the first and second ends of the body,
wherein a force applied on to either or both of the opposing faces
increases a diameter of the aperture.
5. The system of claim 2, wherein the cylindrical body is circular
in cross-section.
6. The system of claim 3, wherein the cylindrical body further
comprises a first portion and a second portion hingedly coupled to
one another and pivotably moveable with respect to one another
between an open position and a closed position.
7. The system of claim 2, wherein the cylindrical body further
comprises a ridge feature extending from an end of the cylindrical
body.
8. The system of claim 2, wherein the cylindrical body further
comprises a groove feature in an end of the cylindrical body.
9. A variable-stiffness guidewire system to be used with an
external medical device, the system comprising: an elongated
flexible guidewire having a body and a guidewire head coupled to
the body, the guidewire having a guidewire collar proximal to the
guidewire head, the guidewire head slidably moveable with respect
to the guidewire collar via a tensioning wire to adjust a stiffness
of at least a portion of the guidewire, the body configured to move
through a lumen of an external medical device; and an insert
coupled to the guidewire and positioned between the guidewire head
and the guidewire collar to maintain a desired stiffness in the at
least a portion of the guidewire, the insert having a
cross-sectional dimension such that a lumen of an external medical
device may be passed over the guidewire while the insert is coupled
therewith.
10. The system of claim 9, wherein the insert further comprises a
cylindrical body having a first end and a second end opposite from
the first end, wherein the first end abuts the guidewire head and
the second end abuts the guidewire collar.
11. The system of claim 10, wherein the cylindrical body further
comprises an aperture running through the body between the first
and second ends, wherein at least a portion of the aperture is
configured to receive a tensioning wire of the guidewire
therein.
12. The system of claim 10, wherein the cylindrical body further
comprises a plurality of opposing faces adjacent to the aperture,
each face extending between the first and second ends of the body,
wherein a force applied on to either or both of the opposing faces
increases a diameter of the aperture.
13. The system of claim 11, wherein the cylindrical body is
circular in cross-section.
14. The system of claim 13, wherein the cylindrical body further
comprises a first portion and a second portion hingedly coupled to
one another and pivotably moveable with respect to one another
between an open position and a closed position.
15. The system of claim 10, wherein the cylindrical body further
comprises a ridge feature extending from an end of the cylindrical
body.
16. The system of claim 11, wherein the cylindrical body further
comprises a groove feature in an end of the cylindrical body.
17. A tension maintaining insert for use with a variable-stiffness
guidewire having a guidewire head moveable with respect to a
guidewire collar of a guidewire body to control a stiffness of the
guidewire, the insert comprising: a cylindrical body having a
cross-sectional dimension no larger than a diameter of a body of a
guidewire, the cylindrical body configured to be positioned between
the guidewire head and the guidewire collar to maintain a stiffness
of the guidewire.
18. The insert of claim 17, wherein the cylindrical body further
comprises a first end and a second end opposite from the first end,
wherein the first end abuts the guidewire head and the second end
abuts the guidewire collar.
19. The insert of claim 18, wherein the cylindrical body further
comprises an aperture running through the body between the first
and second ends, wherein at least a portion of the aperture is
configured to receive a tensioning wire of the guidewire
therein.
20. The insert of claim 19, wherein the cylindrical body further
comprises a plurality of opposing faces adjacent to the aperture,
each face extending between the first and second ends of the body,
wherein a force applied on to either or both of the opposing faces
increases a diameter of the aperture.
Description
STATEMENT OF RELATED APPLICATIONS
[0001] The present application claims the benefit of priority based
on U.S. Provisional Patent Application Ser. No. 61/005,745, filed
on Dec. 7, 2007, and Provisional Patent Application Ser. No.
61/003,404, filed on Nov. 15, 2007, both in the name of inventors
Jay Wright and Samuel Ahn, and entitled "Variable Stiffness
Guidewire Systems."
TECHNICAL FIELD
[0002] The present disclosure relates generally to variable
stiffness guidewire systems.
BACKGROUND
[0003] FIG. 1A illustrates an example of an existing variable
stiffness guidewire system. As shown in FIG. 1A, the guidewire 10
is shown inside the aorta A of a patient, wherein the guidewire 10
is shown inserted through a proximal opening of a catheter hub 12
of a catheter 14 and extending out of a distal opening or lumen 16
of the catheter 14. The guidewire 10 shown in FIG. 1A has the
ability to obtain variable stiffness to allow it to travel through
different arterial branches and also be stable such that the weight
of the catheter 14 and/or other instruments (e.g. balloon catheter,
sensors) or drugs may be delivered to the desired location of the
patient during a medical procedure. The stiffness of the guidewire
10 is variably adjusted at the proximal end by the physician by
pulling a head (not shown) of the guidewire away a desired distance
from the coil body 18 of the guidewire. However, the head of the
guidewire 10 is small in diameter such that pulling the head away
from the coil body 18 usually requires the assistance of a tool
20.
[0004] As shown in FIG. 1A, the tool 20 is significantly larger
than the guidewire 10 which allows the user to comfortably
manipulate the tool 20 and guidewire 10. However, this
configuration of guidewire 10 and tool 20 is disadvantageous
considering that the tool 20 is relatively larger in diameter than
that of the guidewire 10. Thus, the relatively larger tool 20 does
not allow loading and/or unloading of other components over the
catheter 14 at its proximal end 12 without first removing the tool
20 from the guidewire 10. Removing the tool 20 may cause the loss
of tension between the head and coil body of guidewire 10, thereby
effectively causing loss in the desired stiffness and stability in
the guidewire to deliver the instruments or drugs to the desired
location within the patient.
[0005] Accordingly, a need exists for a variable stiffness
guidewire system and tool which allows adjusting of the guidewire
stiffness as well as maintaining that stiffness to allow loading
and unloading of instruments or drugs to the desired location
within the patient without losing or compromising the maintained
stiffness in the guidewire.
OVERVIEW
[0006] Systems for the flexible catheterization of arterial
branches by the percutaneous entry techniques and, more
particularly, such systems provide a variable stiffness guidewire
for advancement into the lumens of branched arteries, vessels and
cavities remote from the point of entry of the catheter. The
systems include removable devices for selectively maintaining
guidewire stiffness by maintaining tension after removal of the
actuator, or tool. Further, the system includes a mechanism for
selectively inserting the removable devices on the tensioned end of
the guidewire.
[0007] In an embodiment, a variable-stiffness guidewire system
comprises an elongated flexible guidewire having a body and a
guidewire head that is coupled to the body. The guidewire head is
slidably moveable with respect to a guidewire collar of the body to
adjust a stiffness of at least a portion of the guidewire. An
insert is coupled to the guidewire and positioned between the
guidewire head and the guidewire collar. The insert has a
cross-sectional dimension no larger than a diameter of the body.
The insert is configured to maintain a distance of the guidewire
head from the guidewire collar to maintain a desired stiffness in
the at least a portion of the guidewire.
[0008] In an embodiment, a variable-stiffness guidewire system to
be used with an external medical device. The system comprises an
elongated flexible guidewire which has a body and a guidewire head
coupled to the body. The guidewire head is slidably moveable with
respect to a guidewire collar of the body to adjust a stiffness of
at least a portion of the guidewire. The body is configured to move
through a lumen of an external medical device. An insert is coupled
to the guidewire and is positioned between the guidewire head and
the guidewire collar to maintain a desired stiffness in the at
least a portion of the guidewire. The insert has a cross-sectional
dimension such that a lumen of an external medical device may be
passed over the guidewire while the insert is coupled
therewith.
[0009] In an embodiment, a tension maintaining insert for use with
a variable-stiffness guidewire that has a guidewire head that is
moveable with respect to a guidewire collar of a guidewire body to
thereby control a stiffness of the guidewire. The insert comprises
a cylindrical body which has a cross-sectional dimension no larger
than a diameter of a body of a guidewire, the cylindrical body
configured to be positioned between the guidewire head and the
guidewire collar to maintain a stiffness of the guidewire.
[0010] In any or all of the embodiments, the insert further
comprises a cylindrical body having a first end and a second end
opposite from the first end, wherein the first end abuts the
guidewire head and the second end abuts the guidewire collar. The
cylindrical body further comprises an aperture running through the
body between the first and second ends, wherein at least a portion
of the aperture is configured to receive a tensioning wire of the
guidewire therein. The cylindrical body further comprises a
plurality of opposing faces adjacent to the aperture, each face
extending between the first and second ends of the body, wherein a
force applied on to either or both of the opposing faces increases
a diameter of the aperture. It is preferred that the cylindrical
body is circular in cross-section. In an embodiment, the
cylindrical body further comprises a first portion and a second
portion that are hingedly coupled to one another and pivotably
moveable with respect to one another between an open position and a
closed position. In an embodiment, the cylindrical body further
comprises a ridge feature extending from an end of the cylindrical
body. It is contemplated that the cylindrical body further
comprises a groove feature in an end of the cylindrical body.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The accompanying drawings, which are incorporated into and
constitute a part of this specification, illustrate one or more
examples of embodiments and, together with the description of
example embodiments, serve to explain the principles and
implementations of the embodiments.
[0012] In the drawings:
[0013] FIG. 1 illustrates a variable stiffness guidewire in
accordance with the prior art.
[0014] FIG. 2A illustrates a variable stiffness guidewire in
accordance with an embodiment.
[0015] FIG. 2B illustrates a perspective view of the proximal end
of the guidewire body in accordance with an embodiment.
[0016] FIG. 2C illustrates a side view of the distal end of the
guidewire body in accordance with an embodiment.
[0017] FIG. 2D illustrates an end view of the distal end of the
guidewire body in accordance with an embodiment.
[0018] FIGS. 3A-3B illustrate diagrams of guidewire tensioning tool
embodiments.
[0019] FIGS. 4A-4D illustrate detailed views of the guidewire
engagement mechanism in accordance with embodiments.
[0020] FIGS. 5A-5C illustrates perspective views of the guidewire
engaging feature of the tool in accordance with embodiments.
[0021] FIG. 6A illustrates a perspective view of the guidewire
engaging feature of the tool 200 in accordance with an
embodiment.
[0022] FIG. 6B illustrates a cross sectional view of the aperture
of FIG. 6A along section B-B in accordance with an embodiment.
[0023] FIG. 6C illustrates an alternate cross sectional view of the
aperture of FIG. 6A along section C-C in accordance with an
embodiment.
[0024] FIGS. 7-10 illustrate diagrams of tools in accordance with
different embodiments.
[0025] FIG. 11 illustrates a perspective view of a C-shaped
guidewire insert in accordance with an embodiment.
[0026] FIG. 12 illustrates a perspective view of a clamshell
guidewire insert in accordance with an embodiment.
[0027] FIGS. 13A-13C illustrate perspective views of a selectively
openable guidewire insert in accordance with an embodiment.
[0028] FIG. 13D illustrates a perspective view of a guidewire with
combinable cartridges in accordance with an embodiment.
[0029] FIG. 14 illustrates a perspective view of an insert
placement tool in accordance with an embodiment.
[0030] FIG. 15 illustrates a perspective view of self-maintaining
guidewire in accordance with an embodiment.
[0031] FIG. 16 illustrates a perspective view of self-maintaining
guidewire in accordance with an embodiment.
[0032] FIG. 17A illustrates a side view of a combined tensioning
and insert applicator deployment tool in accordance with an
embodiment.
[0033] FIG. 17B illustrates an elongated barrel tray in accordance
with an embodiment.
[0034] FIG. 18 illustrates a top view of the combined tensioning
and insert applicator deployment tool in accordance with an
embodiment.
[0035] FIG. 19 illustrates a broken view of a magazine for use in a
deployment tool in accordance with an embodiment.
[0036] FIGS. 20 and 21 illustrate operation of the magazine with
the deployment tool in accordance with an embodiment.
[0037] FIG. 22A illustrates a side view of a combined tensioning as
well as an cartridge applicator and removal tool in accordance with
an embodiment.
[0038] FIG. 22B illustrates operation of the magazine with the
removal tool in accordance with an embodiment.
[0039] FIG. 23A illustrates a perspective view of a guidewire with
integrated tension head and tension maintaining mechanism in
accordance with an embodiment.
[0040] FIG. 23B illustrates a perspective view of a guidewire with
integrated tension head and tension maintaining mechanism in
accordance with an embodiment.
[0041] FIG. 24 illustrates a side view of the integrated guidewire
tension maintaining head with a deployment tool in accordance with
such an embodiment.
DETAILED DESCRIPTION
[0042] Example embodiments are described herein in the context of a
variable stiffness guidewire system. Those of ordinary skill in the
art will realize that the following description is illustrative
only and is not intended to be in any way limiting. Other
embodiments will readily suggest themselves to such skilled persons
having the benefit of this disclosure. Reference will now be made
in detail to implementations of the example embodiments as
illustrated in the accompanying drawings. The same reference
indicators will be used throughout the drawings and the following
description to refer to the same or like items.
[0043] In the interest of clarity, not all of the routine features
of the implementations described herein are shown and described. It
will, of course, be appreciated that in the development of any such
actual implementation, numerous implementation-specific decisions
must be made in order to achieve the developer's specific goals,
such as compliance with application- and business-related
constraints, and that these specific goals will vary from one
implementation to another and from one developer to another.
Moreover, it will be appreciated that such a development effort
might be complex and time-consuming, but would nevertheless be a
routine undertaking of engineering for those of ordinary skill in
the art having the benefit of this disclosure.
[0044] In general, a variable stiffness surgical guidewire system
for use with a flexible catheter, the system includes an elongated
flexible guidewire and an actuator (also referred to as tool)
selectively coupleable to the proximal end of the flexible
guidewire for selectively controlling the stiffness of, at least,
sections thereof. The system can be used in, for example, medical
techniques for treating systems including vascular, urinary,
genital, gastro-intestinal, respiratory, biliary, and neurological
systems. Preferably, the system may also include a removable device
to selectively maintain guidewire stiffness by maintaining tension
after removal of the tool.
[0045] FIG. 2A illustrates a guidewire 100 in accordance with an
embodiment for use during a surgical procedure. As shown in FIG.
2A, the guidewire 100 is shown inside the aorta A of a patient,
wherein the guidewire 100 is inserted through a proximal opening 12
of a catheter 14 and extends out of a distal opening or lumen 16 of
the catheter 14. In contrast to the guidewire 10 in FIG. 1, the
guidewire 100 in FIG. 2A includes a tension wire 102 at its
proximal end as well as tension head 104 which is exposed and may
be manipulated by the user.
[0046] The tension head 104 is movable with respect to the body 106
of the guidewire 102. The guidewire 100 has a variable stiffness
feature in which the stiffness of the guidewire 100 varies
proportionally with the distance between the tension head 104 and
the coil body 106. Therefore, in operation, the stiffness a portion
or all of the guidewire 100 will increase as the tension head 104
is moved away from the body 106. In contrast, movement of the
tension head 104 in the opposite direction (toward the body 106)
will cause the stiffness of the guidewire 100 to decrease.
Maintaining the position of the tension head 104 with respect to
the body 106 at a particular position will maintain the stiffness
of the guidewire body 106. In particular, the construction of the
guidewire 100, as will be discussed in more detail below, allows
the distal end of the guidewire 100 to remain stationary while the
stiffness of the guidewire is increased.
[0047] FIG. 2B illustrates a perspective view of the proximal end
of the guidewire 100 in accordance with an embodiment. As shown in
FIG. 2B, the guidewire 100 includes a coil body 106, a tension wire
102 coupled to the body 106 extendable out of the body 106, and a
tension head 104 coupled to the tension wire 102. In addition, the
guidewire 100 is shown in FIG. 2B to preferably have a collar 108'
which represents a portion of the end of the coil body 104 that is
closest to the tension head 104.
[0048] In an embodiment, the collar 108' is formed by soldering and
metal flowing together 3-5 windings of the coil at the proximal end
of the coil body wire 106. Thereafter, it is preferred that the
soldered area is grounded and smoothed to create a smooth outer
circular body with a flat collar end 108 which is perpendicular to
the outer surface 108 of the collar in accordance with an
embodiment. The guidewire 100 benefits from construction of the
collar 108' as the collar 108' serves to increase the structural
stability as well as the ability to bear tension (and resulting
increased stiffness) enabled by soldering the end coils together.
The collar 108' also serves as a retaining wall which allows the
windings of the guidewire to contract and press against one another
when the stiffness of the guidewire 100 is increased. It should be
noted that soldering and metal flowing is one example of creating
the collar 108' and that any other appropriate method is
contemplated. It is also contemplated that the guidewire 100 not
use a collar 108' but some other member which serves the functions
of a retaining wall that allows the coil windings of the guidewire
100 to contract press together when an increase in stiffness of the
guidewire 100 is desired.
[0049] FIG. 2C illustrates a side view of the distal end of the
guidewire body in accordance with an embodiment. FIG. 2D
illustrates an end view of the distal end of the guidewire body in
accordance with an embodiment. As shown in FIGS. 2B and 2C, the
tension wire 102 preferably is comprised of one or more wires which
are wound together to form a coiled or cable type body, whereby the
coils of the tension wire 102 are opposite to the coils of the
outer body 106. The tension wire 102 has a proximal end and a
distal end, whereby the proximal end of the wire 102 is attached to
the tension head 104 as shown in FIG. 2B. In an embodiment, the
tension head 104 is separately manufactured from the tension wire
102 such that both components are coupled to one another. In an
embodiment, the tension wire 102 is formed with the tension head
104 being integrally formed therewith.
[0050] The distal end of the tension wire 102 is attached to the
distal end 109 of the body 106 of the guidewire 100. As shown in
FIGS. 2C and 2D, the distal end of the wire 102 is positioned at
the distal end 109' of the guidewire 100, whereby the outer body
106 is preferably crimped to securely mount the tension wire 102 to
the outer body 106. In particular, as shown in FIG. 2D, the crimped
areas 111 force the body 106 to apply a frictional force onto the
tension wire 102, thereby allowing the wire 102 and the body 106 to
withstand more tension force during stiffening of the guidewire 100
than previous soldering methods. Once the ends of wire 102 and
outer body 106 are crimped, the distal end 109 is preferably
smoothed by known methods (e.g. soldering, machining) to form a
smooth, rounded distal end 109 of the guidewire 100. In the
embodiment shown in FIG. 2D, an 8-point micro-crimp style tool may
be used to crimp the outer body 106 to the tension head 102, it
should be noted that any other appropriate tool may be
utilized.
[0051] As stated above, the coil windings of the tension wire 102
are opposite to that of the outer body 106 of the guidewire 100. In
an embodiment, the coil windings of the outer body 106 traverse
clockwise along the length of the body 106, whereas the coil
windings of the tension wire 102 traverse counterclockwise along
the length of the wire 102, or vice versa. The opposite windings of
the two members allow the distal end of the guidewire 100 to
maintain its dimensional stability while the guidewire 100 is
stiffened and under tension. Additionally, the opposed windings
allow the distal end of the guidewire 100 to maintain its location
with respect to its proximal end while under tension. Further, the
method of crimping the ends of the tension wire 102 and outer body
106 allows tension to be applied-to and released-from the guidewire
100 multiple times without crushing or damaging the outer body 106.
Accordingly, the preferred design of the guidewire 100 discussed
above specifically minimizes or avoids distal tip 109 deflection as
well as any tendency for the distal portion of the guidewire 100 to
straighten itself out with respect to the proximal end. By allowing
the distal portion 109 to maintain its position while the guidewire
100 is stiffened, the user is provided the positional stability to
deliver the necessary surgical instruments and/or medicine to be
delivered more consistently and accurately to the desired location
within the patient. It should be noted that the other figures
herein depicting the guidewire 100 may not show the coiled tension
wire 102 for clarity purposes.
[0052] An example of the construction for guidewire 100 is as
follows: the body 106 has an outer diameter of
0.035''.times.0.007'' of 304 sst wire.times.150 cm-300 cm long coil
body. Additionally, 5-10 coils located at the proximal end of the
outer body 106 are soldered together and polished or grounded to
form the collar 108' and collar end 108. With the outer diameter of
the collar 108' preferably having the same outer diameter as the
outer diameter of the coil body 106, and the inner diameter 103 of
the collar 108' having a slightly larger diameter than the outer
diameter of the tensioning wire 102, whereby the outer body 106
moves freely over the tension wire 102. One example of an
acceptable tension wire 102 has a 0.015'' outer diameter 304sst
monofilament tension core which provides excellent tensile strength
(approximately 70 lbs.) and acceptable stiffness.
[0053] A preferred example of the tension wire 102 is a cable-braid
wire which provides excellent tensional strength and stiffness and
superior positional stability of the distal end of the guidewire
100 when under tension. In an embodiment, left hand or right hand
wound coiled bodies of the guidewire 100 are acceptable for use
with left hand or right hand twist cables or monofilament core
wires. The oppositely configured outer coil body and tension wire
are such that the user experiences improved torsional stability
when the guidewire 100 is tensioned to a desired stiffness. This
configuration may be more favorable than others for certain
applications requiring, namely, additional torsional strength and
dimensional stability during the procedures.
[0054] Referring back to FIG. 2B, the tension wire 102 and head 104
are shown a distance away from the collar 108 and body 106 in a
default natural state. The guidewire 100 is designed such that the
body 106 will increase in stiffness as the head 104 (and wire 102)
is further actuated away from the collar 108. In contrast, the body
106 will decrease in stiffness as the tension head 104 (and wire
102) is moved toward the collar 108 of the body 106.
[0055] As stated, it is preferred that the head 104 is positioned a
certain distance from the collar in a default nature state, whereby
a portion of the wire 102 remains exposed outside the collar 108.
Alternatively, the head 104 abuts the collar 108 and the wire 102
is completely within the body 106 when the guidewire 100 is in the
default, natural state. For purposes of this description, it will
be assumed that the head 104 is positioned a certain distance from
the collar 108 and a portion of the wire 102 is exposed, as shown
in FIG. 2B, when the guidewire 100 is at its default natural
state.
[0056] As shown in FIG. 2A, the body 106 has a diameter D, whereby
the tension wire 102 has a diameter d.sub.w, and the tension head
104 has a width dimension w.sub.h. The diameter d.sub.w of the
tension wire 102 is preferably smaller than the diameter D of the
body 106. Additionally, it is preferred that the width w.sub.h of
the tension head 104 is greater than the diameter d.sub.w of the
tension wire 102 but preferably smaller than the diameter D of the
body 106. Considering that the inner diameter of the instrument or
drug carrying catheter is slightly larger than the diameter D of
the body, a smaller width dimension w.sub.h of the tension head 104
will ensure that the medical instruments and drug may be loaded or
unloaded directly over the head 104 of the guidewire 100 without
problems or resistance.
[0057] It should be noted that the tension head 104 is shown in
FIG. 2B to have a triangular shape. Although this is a preferred
shape, the tension head 104 may alternatively have any other shape
including, but not limited to, square, hexagonal, pentagonal,
trapezoidal, spherical, circular, etc. Considering that the head
104 is shown as triangular in the embodiment in FIG. 2A, the width
dimension w.sub.h is the length of a longest side (or any side if
the head 104 is an equilateral triangle). In an embodiment that the
head 104 is another shape, the width dimension w.sub.h is
preferably the length of the longest side of the shape.
[0058] FIG. 3A illustrates a diagram of a guidewire tensioning tool
in accordance with an embodiment. As shown in FIG. 3A, the tool 200
includes a body having a first portion 202A and a second portion
202B, whereby each portion has a pair of respective jaws 204A, 204B
and a pair of respective handles 206A, 206B coupled to one another
at a fulcrum 208. A spring-like member 210 is preferably coupled to
both sides 202A, 202B. The spring-like member 210 preferably
applies an inwardly directed force F.sub.s (as shown by the arrows)
which urges the handles 206A, 206B to move toward each other and
thereby urging the jaws 204A, 202B to move apart from one another
by default. It should be noted that although a regular spring 210
is shown in the Figures of the tool 200, it is contemplated that
any type of resilient material may be used in substitution to a
typical spring, including but not limited to, a leaf spring, foam,
elastics, etc.
[0059] The jaws 204A, 204B are configured to receive and engage the
tension head 104 of the guidewire 100. In particular, controlled
movement of the jaws 204A, 204B toward or away from one another
will result in the corresponding stiffness or flaccidness of the
guidewire body 106. As will be discussed, the jaw 204B preferably
includes a guidewire engagement feature which allows the jaw to
engage the tension head 104 during operation. Some example
embodiments of the guidewire engagement feature will now be
described in FIGS. 4A-4D.
[0060] FIG. 4A illustrates a detailed view of the guidewire
engagement feature in accordance with an embodiment. As shown in
FIG. 4A, the tool 200 has jaws 204A and 204B, whereby jaw 204A will
be referred to as the distal jaw 204A and jaw 204B will be referred
to as the proximal jaw 204B. The distal jaw 204A shown in FIG. 4A
has an open fork aperture 218 which allows the wire 102 to
vertically slip downward into the aperture 218 from the top surface
of the jaw 204A. In an embodiment, the jaw 204A has a flanged
portion 207 is maintains the position of the collar 108 and
prevents it from moving vertically upward the top surface of the
jaw 204A and disengaging from the jaw 204A. The aperture's 218
cross-sectional dimension is preferably smaller than the diameter
of the collar 108 such that the collar 108 remains to the outside
surface 220 of the distal jaw 204A. In an embodiment, the cross
sectional dimension of the aperture 218 is constant from the
outside surface 220 to the inside surface 222 of the distal jaw
204A. In an embodiment, as shown in FIG. 4D, the cross sectional
dimension of the aperture 218 is not constant from the outside
surface 220 to the inside surface 222, but instead has a recessed
portion 224 which allows the collar to sit within a portion of the
distal jaw 204A. In an embodiment, the aperture 218 has a tapered
shape in which the size of the aperture is larger near the outside
surface 220 than the inside surface 222.
[0061] FIGS. 4B and 4C illustrate different types of jaw
configurations. In FIG. 4B, the proximal jaw 204B has a open-ended
fork arrangement, such as a pliers beak, as with the distal jaw
204A. The flange 205' of the proximal jaw 204B prevents the head
104 from vertically running upward and disengaging from the jaw
204B. FIG. 4C illustrates the distal jaw having a tapered flange
207' design which also maintains the collar 108 again the outer
surface of the jaw 204A.
[0062] Additionally, the proximal jaw 204B preferably includes an
engaging aperture 230 therethrough which has a cross-sectional
dimension large enough to allow the tension head 104 to extend
through, whereby the tension head 104 engages the outer surface 228
when inserted through the engaging aperture 230 from the inner
surface 226 to the outer surface 228. However, once the tension
head 104 passes through the engaging aperture 230, the aperture 230
is selectively engaged with the tool 220, whereby the head 104 is
unable to pass through the aperture 230 back toward the collar body
108 until desired by the user.
[0063] FIGS. 5A-5C illustrates perspective views of the guidewire
engaging feature of the tool 200 in accordance with an embodiment.
It should be noted that although the engaging feature is described
within the context of the tool 200, the engaging feature may be
incorporated in any other of other devices described herein (e.g.
tools 1200, 1400, 1500 discussed below). As stated above, the
tension head 104 preferably has a triangular shape in an
embodiment. Similarly, in an embodiment, the engaging aperture 230
has a similar triangular shaped passage through the entire
thickness of the proximal jaw 204B and/or the distal jaw 204A, as
shown by the phantom lines in FIG. 5A. In FIG. 5A, the triangular
head 104 is shown passing through the aperture 230 from the inner
surface 226 to the outer surface 228 of the jaw 204B, whereby the
shape of the head 104 is in communication and registers with the
corresponding shape of the aperture 230. As such, the dimensions of
the aperture 230 are at least slightly larger than the dimensions
of the head 104 to allow the head 104 to traverse through the
aperture 230. In FIG. 5B, the head 104 traverses entirely through
the aperture 230 and is rotated about axis A, as shown by the
arrows, to allow the head 104 to be engaged with a tool 200, 1200
as discussed below. In an embodiment, the head 104 does not rotate,
but instead the jaw 204B is rotated to bring the combination to the
configuration in FIG. 5C.
[0064] In FIG. 5C, the head 104 is rotated 60 degrees out of
alignment with the aperture 230, whereby the head 104 is then urged
into frictional contact with the outer surface 228 of the jaw 204B
by the guidewire body 106. By being in frictional contact with the
outer surface 228 of the jaw 204B, the head 104 is thereby engaged
and in a locked position with the jaw 204B. To unlock and disengage
the head 104 from the tool 200, the head 104 is rotated 60 degrees
about axis A until it is aligned with the aperture 230, as shown in
FIG. 5A.
[0065] FIG. 6A illustrates a perspective view of the guidewire
engaging feature of the tool 200 in accordance with an embodiment.
It should be noted that although the engaging feature is described
within the context of the tool 200, the engaging feature may be
incorporated in any of the other devices described herein (e.g.
tools 1200, 1400, 1500). In an embodiment, the aperture 230'
includes a recessed portion 232 which is 60 degrees out of
alignment with the aperture 230' such that the head 104 is securely
seated within the recessed portion 232 when in the locked and
engaged position. The recessed portion 232 secures the head 104 and
prevents the head 104 from unintentionally rotating when engaged by
the jaw 204B' or any of the other devices described herein (e.g.
tools 1200, 1400, 1500). FIG. 6B illustrates a cross sectional view
of the aperture 230' along section B-B in accordance with an
embodiment.
[0066] FIG. 6C illustrates an alternate cross sectional view of the
aperture 232' in which the recess tapers outward toward the outer
surface 230'. In the embodiment in FIG. 6C, the rounded tapered
shaped recess 232' facilitates easier interfacing and engaging as
well as disengaging of the triangular head 104 from the aperture
232'.
[0067] Once the head 104 is engaged and in a locked position with
the tool 200, the guidewire 100 is then able to be manipulated
using the tool. Referring back to the tool embodiment shown in FIG.
3A, the tool 200 includes a stiffness adjustment mechanism 212
which serves to provide an equal and opposing force to the spring
210 to stabilize mechanical movement of the jaws 204A, 204B. The
embodiment of the adjustment mechanism 212 shown in FIG. 3A
comprises a nut 216 and one or more bolts 214A, 214B which are
coupled to the tool 200 in the embodiment shown in FIG. 3A. The
adjustment mechanism 212 operates by rotation of one or both of the
nuts 214A, 214B in predetermined directions which thereby causes
the bolt 216 to move transversely in the desired direction (as
shown by the arrow). For example, rotation of the nut 214A and/or
214B in a predetermined direction will cause the nut 216 to move
toward the fulcrum 208 and eventually abuts the middle body 218 of
the tool 200. Considering that the spring like member 210 urges the
handles 206A, 206B toward one another (and thus the jaws 204A, 204B
away from each other), the bolt 216, upon applying a counter force
to the middle body 218, will cause handles 206A and 206B to move
away from one another and ultimately force the jaws 204A, 204B of
the tool to move closer to one another. Considering that the
stiffness of the engaged guidewire 100 increases as the jaws 204A,
204B are moved apart from one another, the adjustment mechanism
212, by default or when not in use, presses against the middle body
218 and causes the handles 206A, 206B to be apart from one another
a maximum allowable distance. This allows the tool 200 to allow
easy manipulation of the guidewire 100. FIG. 3B illustrates the
preferred default position of the tool 200 in accordance with an
embodiment.
[0068] In operation, upon the head 104 of the guidewire 100 being
engaged by the tool 200, the user is able to manipulate the
adjustment mechanism 212 by pressing the handles 206A, 206B toward
each other and thereby moving the jaws 204A, 204B away from one
another. The gradual movement of the jaw 204B away from jaw 204A
forces the tension head 104 away from the collar 108 and thus
gradually increases the stiffness of the guidewire 100 to a desired
amount. In an embodiment, the tool 200 may include a caliper type
measuring feature which allows the user to know the amount of
stiffness the guidewire 100 is undergoing based on the measured
distance between the jaws 204A, 204B (FIG. 10).
[0069] FIG. 7 illustrates a diagram of a tool in accordance with an
embodiment. As shown in FIG. 7, the tool 300 is similar in design
and operation to the tool 200 described in FIGS. 3A and 3B. In
contrast to the tool 200, the tool 300 includes a hard stop
mechanism 312 configured to provide one or more fixed stops,
whereby each stop represents a predetermined distance between jaws
304A and 304B. The stop 312 shown in FIG. 7 is preferably fixed and
defines the maximum distance (and thus maximum stiffness in the
guidewire 100) which jaws 304A, 304B may be apart from one another
when the tension head 104 is engaged thereto. In operation, middle
body 318 is shaped such that it comes into contact with the stop
312 and thus does not allow handles 302A, 302B to be pressed toward
one another any further. In operation, the hard stop mechanism 312
allows the guidewire 100 to achieve three levels of stiffness: soft
or no stiffness when the guidewire 100 is not engaged to the tool
300, intermediate stiffness when the guidewire 100 is engaged to
the tool 300 but the handles 302A, 302B are not pressed together,
and maximum stiffness when the guidewire 100 is engaged to the tool
300 and the middle body 318 is pressing against the hard stop
312.
[0070] FIG. 8 illustrates a diagram of a tool in accordance with an
embodiment. As shown in FIG. 8, the tool 400 is similar in design
and operation to the tool 200 described in FIGS. 3A and 3B. In
contrast to the tool 200 in FIGS. 3A and 3B, the tool 400 includes
an adjustment mechanism 412 having a cam 414 configured to rotate
about a cam axle 416 and which includes one or more cam surfaces
418 which bear against the middle body 420 to move the jaws 404A,
404B toward or away from each other a predetermined distance. In
particular, the cam 414 shown in FIG. 8 includes three cam surfaces
418A, 418B, and 418C, the cam surfaces having respective radii,
r.sub.1, r.sub.2, r.sub.3 with respect to the cam axle 416. It
should be noted that any number of cam surfaces 418, including just
one, is contemplated. In the embodiment shown in FIG. 8, the three
radii of the cam surfaces 418A, 418B, and 418C are related as
follows: distance of r.sub.1 to axle <distance of r.sub.2 to
axle <distance of r.sub.3 to axle. Considering that the spring
410 urges the handles 402A and 404B toward one another, the cam 414
applies a force to the middle body which opposes the spring force
F.sub.S. Thus, if the cam 414 is actuated such that cam surface
418A having the largest radius, r.sub.3, is in contact with the
middle body, the cam 414 will force the handles 402A, 402B to move
away from one another the greatest distance. This results in the
jaws 404A, 404B being moved toward each other. In contrast, as the
cam 414 is actuated to a position where the cam surface 418A having
the smallest of the available radii, r.sub.1, is in contact with
the middle body, the cam 414 will force the handles 402A, 402B to
move toward one another. This results in the jaws 404A, 404B moving
away from one another tool 400, thereby effectively increasing the
stiffness in the guidewire 100.
[0071] FIG. 9 illustrates a diagram of a tool in accordance with an
embodiment. As shown in FIG. 9, the tool 500 is similar in design
and operation to the tool 200 described in FIGS. 3A and 3B. In
contrast to the tool 200 in FIGS. 3A and 3B, the tool 500 includes
an adjustment mechanism 512 having a detent assembly which
functions, somewhat analogously to a torque wrench, for allowing
the selection of maximum applied tension. The detent setting may be
set to a specific force (much like a torque wrench) such that once
the designated force to the tool handle exceeds the desired level,
the detent mechanism 512 activates and prevents further tensioning
of the guidewire. The detent mechanism 512 thus can act as a form
of a "safety" against over tensioning the guidewire.
[0072] FIG. 11 illustrates a perspective view of a guidewire insert
or cartridge in accordance with an embodiment. As shown in FIG. 11,
the cartridge (also referred to herein as an insert) 600 is
positioned between the head 104 and the collar 108 of the guidewire
body 106, whereby the cartridge 600 maintains the stiffness in the
guidewire 100 by maintaining the head 104 at a desired distance
from the collar 108. In particular, the cartridge 600 has a
cylindrical body having a proximal end 602 which abuts an inner
surface 105 of the guidewire head 104 and a distal end 604 which
abuts the guidewire's collar 108. In addition, the cartridge 600
has an inner diameter 606 substantially equal or slightly larger
than the diameter of the guidewire's tension wire 102. The
cross-section of the cartridge is preferably in the shape of a
trapezoid as shown in FIG. 11, although other shapes are
contemplated (e.g. C-shaped, square, triangular, etc.) With regard
to the embodiment in FIG. 11, the trapezoidal cross-section of the
cartridge produces two opposing sides 603 as well as two adjacent
faces 601. The opposing sides 603 allow the cartridge to be easily
grasped by an engagement tool (discussed below) whereas the
adjacent faces 601 allow the cartridge to be easily disengaged by
the disengaging tool (discussed below). The adjacent faces 601
preferably encompass 210 degrees of the wire 102, although other
angles are contemplated. This configuration (shown in FIGS. 20-22B)
allows the disengaging tool to push the faces 601 downward to
slightly increase the diameter 606 of the cartridge 600 to
disengage the cartridge 600 from the tension wire 102.
[0073] The cartridge 600 may be constructed of a durable, rigid,
yet slightly flexible material having a high longitudinal
compressive strength (e.g. Lexan, Plexiglas, Lucite, Perspex) so
that the cartridge 600 can flex open and snap into circumferential
position over the core wire 102 and later spring open when it is
pushed "away" from the core wire 102 so as to permit removal of the
cartridge 600.
[0074] It is preferred that the cartridge 600 is smaller than or
equal to the diameter of the guidewire's body 106 as well as the
cross section of the lumen of the instrument or drug carrying
catheters with which the guidewire 100 operates. Accordingly, the
cartridge 600 allows the user the freedom to load, unload, advance
and retract surgical devices over the proximal end of the guidewire
and cartridge 600 while the desired stiffness of the guidewire 100
is maintained without compromising the stiffness of the guidewire
100 and without removing the cartridge 600. Thus, the configuration
and dimensions of the cartridge 600 allows the tension of the
guidewire 100 to be maintained while the exchange of catheters,
balloons, stents and/or other surgical tools and medicine may occur
over the guidewire 100 without having to remove the cartridge 600
or exchange guidewires.
[0075] FIGS. 12 and 13A-13D illustrate perspective views of a
selectively openable guidewire insert 800 in accordance with an
embodiment. As shown, the insert 800 is positioned between the head
104 and the collar 108 of the guidewire body 106, whereby the
insert 800 maintains the stiffness in the guidewire 100 by
maintaining the head 104 at a desired distance (and desired
tension) from the collar 108. In particular, the insert 800 has a
cylindrical body having a proximal end 808 which abuts the
guidewire head 104 and a distal end 810 which abuts the guidewire's
collar 108 when the insert 800 is coupled to the tension wire 102.
In addition, as shown in FIG. 13A, the insert 800 has an inner
diameter 812 as well as an outer diameter 814, whereby the inner
diameter 812 is substantially equal or slightly larger than the
diameter of the guidewire's tension wire 102. It is preferred that
the outer diameter 814 of the insert 800 is smaller than or equal
to the diameter of the guidewire's body 106. Further, it is
preferred that the overall outer diameter of the insert 800 is
smaller in cross section than the lumen of the surgical components
with which the guidewire 100 operates. Accordingly, the insert 800
allows the user the freedom to load, unload, advance and retract
surgical devices over the proximal end of the guidewire and insert
800 while the desired stiffness of the guidewire 100 is
maintained.
[0076] As shown in FIG. 12, the insert 800 has a clam-shell
configuration having a lower portion 802 and an upper portion 804
coupled to one another at a hinge 806. The hinge 806 may be created
as an integral score in the insert's 800 material. This
configuration allows the insert 800 to be applied over the extended
wire 102 in an open position (as shown in FIG. 12) and then
actuated or snapped to a locked position by closing the clam shell
configuration around the extended wire 102. The material of the
insert 800 is durable and rigid to force the head 104 from the
collar 108 and thus maintain stiffness in the guidewire 100.
[0077] In operation, after the tool 200 moves the head 104 a
desired distance with respect to the collar 108 to achieve the
desired amount of stiffness, the clamshell-like insert 800 is
applied and secured around the tension wire 102 to maintain the
increased guidewire stiffness after the tool 200 is removed. As
discussed below, the upper and lower portions of the insert 800 may
be completely separated from one another prior to and/or after the
insert 800 is coupled to the tension wire 102.
[0078] FIG. 13A illustrates the clamshell insert 800 having a
snap-fit configuration in which the upper portion 804 includes one
or more male protrusions 818 and the lower portion 802 includes one
or more female receivers 816 which receive the male protrusions 818
to lock the insert 800 in the closed position. It should be noted
that the snap-fit configuration shown in FIG. 13A is an example
only and other appropriate locking mechanisms are contemplated. For
example, the lower and upper portions 802, 804 may be maintained in
the closed position by magnets, screws, etc. In addition, the
insert 800 may be made of any appropriate material which maintains
the head 104 at the desired distance from the collar 108. For
example, the insert 800 may be made of durable plastic, stainless
steel, aluminum, composite alloys, etc. Inserts 800 of different
length may be provided to sustain various amounts of stiffness in
the guidewire 100. In an embodiment, the insert 800 may be stamped
to have stiffness information on its outer surface to easily inform
the user as to how much tension the guidewire 100 will experience
upon the insert 800 being applied thereto. In an embodiment, the
insert 800 may be disposable and of one-time use, although the
insert 800 may alternatively be reused. It should be noted that the
above-described design of the insert 800 facilitates fast, simple
placement and removal.
[0079] FIG. 13B illustrates an embodiment in that the insert 800 is
shown almost closed over the tension wire 102. As shown in FIG.
13B, the insert 800 includes an opening 820 along which extends
from one end to the opposite end of the body, whereby the opening
remains even after the insert 800 is actuated to the closed
position. The opening 820 allows a corresponding tool to remove the
insert from the tension wire 104 by pulling the portions adjacent
to the opening 820 apart enough to increase the width of the
opening 820. Upon width of the opening 820 being large enough, the
insert 800 will then be able to be easily removed from tension wire
102. This allows the user to quickly remove the insert 800 to
adjust the stiffness of the guidewire 100. It should be noted that
the above-described design of the insert 800 facilitates fast,
simple placement and removal.
[0080] FIG. 13D illustrates a perspective view of a guidewire with
combinable cartridges in accordance with an embodiment. As shown in
FIG. 13D, the guidewire 100 includes an index groove 110 located on
the collar 108. In addition, the tension head 104 is shown to
include an index ridge 112, whereby the ridge 112 is configured to
fit completely into index groove 110 when the tension head 104
abuts the collar 108 when the guidewire 100 is in a relaxes natural
state.
[0081] In the embodiment in FIG. 13D, one or more cartridges 822
are shown coupled to the guidewire 100 whereby the cartridges are
shown consecutively linked to one another to maintain a specified
tension in the guidewire 100. In particular, cartridge to 822A and
cartridge 822B are coupled to one another and positioned end to end
between the tension head 104 and the collar 108 of the guidewire
100. As shown in FIG. 13D, cartridge 822A includes a cartridge
groove or detent 824A on the end proximal to the tension head 104
and a cartridge ridge or protrusion 826A on the opposite end.
Similarly, cartridge 822B includes a cartridge groove 824B on the
end which abuts the cartridge ridge 826A of cartridge 822A and a
cartridge ridge 826B on its opposite end, whereby the cartridge
ridge 826B fits within the index groove 110 of the guidewire 100.
It should be noted that the index ridge 112 and index groove 110 of
the guidewire 100 are not required to utilize the consecutive
cartridges having the indexed ridges and grooves. It should also be
noted that although two cartridges you shown in FIG. 13D, any
number of cartridges may be used with the guidewire. It is also
contemplated that any cartridge may have the same features (ridges
and/or grooves) on both ends. It should also be noted that the
groove and/or ridge features may be applied to any of the other
inserts discussed herein and is not limited to only the figures
which show them.
[0082] Cartridges 822A, 822B each have a length dimension such that
the guidewire 100 will undergo a certain amount of stiffness when
only one cartridge is used. However, as shown in FIG. 13D, the
guidewire 100 will undergo additional stiffness when both
cartridges are combined serially and placed over the tension wire
102 of the guidewire 100. This allows the user to variably adjust
the amount of stiffness desired on the guidewire 100 by adding or
removing cartridges 822 during the procedure. In an embodiment, the
cartridges are of equal length, although the cartridges may be of
varying lengths in an embodiment. In an embodiment, each cartridge
may be marked, or color-coded, with a value which represents the
amount of tension which the guidewire 100 would undergo when that
particular cartridge is coupled to the guidewire 100. In a further
embodiment, these values may be combined to provide a combined
tension value which represents the amount of tension which the
guidewire 100 would undergo when those combined cartridges are
coupled to the guidewire 100. As with the other cartridges
described herein, the cartridges in FIG. 13D preferably have an
outer diameter smaller than or equal to the outer diameter of the
guidewire body 106 to allow ease of loading and unloading of
instrument and drug catheters without compromising stiffness in the
guidewire 100.
[0083] FIG. 14 illustrates a perspective view of an insert
placement tool in accordance with an embodiment. As stated above,
the upper and lower portions of the insert 800 (FIG. 12) may be
completely separated from one another prior to and/or after the
insert 800 is coupled to the tension wire 102. In other words, the
upper 804 and lower portions 802 of the insert 800 (FIG. 12) may be
separate pieces which are not attached at a moveable hinge, but
instead include an attachment means which allow the portions 802,
804 to be attached together when coupled to the tension wire 102
and completely disattached from one another when not coupled to the
tension wire 102. Such an attachment means may be snap features,
magnets, screws, tacks, etc.
[0084] In FIG. 14, the insert placement tool 900 is utilized to
couple and/or remove the upper and lower portions 804, 802 with
respect to the tension wire 102. The tool 900 includes an upper
clasp 902 and a lower clasp 904 which are moveable with respect to
one another about the joint 906. A pair of handles 908A, 908B are
coupled to the joint 906 and are moveable to selectively operate
the clasps 902, 904 to move toward and away from one another.
[0085] In an embodiment, the claspers 902, 904 have a length
dimension which is smaller than the length of the upper and lower
portions 802, 804 of the insert 800. This allows the claspers 902,
904 to be placed between the jaws 204A, 204B of the extender tool
200 (FIG. 3A) to deliver the insert 800 to the tension wire 102
while the head 104 is extended away from the guidewire's collar
108. Once the claspers 902, 904 are placed over the tension wire
102, the user preferably actuate the handles 908A, 908B toward one
another to couple the upper and lower portions 802, 804 of the
cartridge 800 to one another and around the tension wire 102. The
insertion tool 900 thereby "snaps" the insert 800 over the tension
wire 102 and the tool 900 is then removed from between the tool's
jaws. In an embodiment, the clapsers 902, 904 do not deliver the
insert 800, but instead are themselves placed between the tension
head 104 and the collar 108 to maintain the stiffness of the
guidewire after the tool 200 is removed.
[0086] FIG. 15 illustrates a perspective view of self-maintaining
guidewire 1000 in accordance with an embodiment. As shown in FIG.
15, the guidewire 1000 includes an aperture 1010 (shown in phantom
lines) through the tension wire 1002. Although only one aperture
1010 is shown in FIG. 15, any number of apertures 1010 may be
configured along the tension wire 1002. The aperture 1010 is
configured to receive a setting pin 1012 therethrough, whereby the
guidewire 1000 is able to maintain the desired stiffness when the
setting pin 1012, inserted in the desired aperture 1010, abuts the
collar 1008. It is preferred that apertures 1010 are configured in
a spaced fashion such that the pin 1012 may be inserted into any of
the available apertures 1010 which correspond to the desired
stiffness which the user wants the guidewire 1000 to achieve.
[0087] FIG. 16 illustrates a perspective view of self-maintaining
guidewire 1100 in accordance with an embodiment. As shown in FIG.
16, the guidewire 1100 includes a foot 1110 which is configured
within a corresponding recess 1112 within the tension wire 100. The
foot 1110 is preferably urged upward away from the wire 1102 by a
spring 1114, such that the foot 1110 "pops out" when it is extended
out from within the body 1106 past the collar 1108. In operation,
once the tension wire 1102 is extended far enough from the
guidewire body 1106, the foot 1100 springs out from the recess 1112
and abuts the collar 1108 to maintain the position and tension of
the guidewire 1100. In an embodiment, the tension wire 1102 can be
retracted and the guidewire relaxed by pressing the foot 1100 back
into the recess 1112 using a tool (e.g. hemostat) and allowing the
tension head 1104 to retreat back toward the default position.
[0088] FIG. 17A illustrates a side view of a combined tensioning
and insert applicator tool in accordance with an embodiment. In
particular, the tool 1200 includes a handle member 1202, a trigger
member 1204, an elongated tray 1206, a collar interface 1210, and a
tension brace 1212. In an embodiment, the handle member 1202 is
designed to have a pistol grip and an elongated trigger member as
shown in FIG. 17A, however any other appropriate shape for the
handle 1202 and trigger member 1204 is contemplated.
[0089] A proximal end 1208 of the elongated tray 1206 is
mechanically and operably coupled to the handle 1202 and the
trigger 1204. The distal end of the tray 1206 terminates with a
collar interface 1210 which is configured to abut the collar 108 of
the guidewire body 106 when the tool 1200 is in operation. The
collar interface 1210 preferably includes a notch 1216 (FIG. 18)
through which the tension wire 102 passes while the tool 1200 is
operating with the guidewire 100. The elongated tray 1206 in the
embodiment shown in FIG. 17A has an open top in which the tension
brace 1212 is exposed. This embodiment allows the user to view the
tensioning of the guidewire and as well as movement of the tension
brace 1212 along the elongated tray 1206.
[0090] In contrast, FIG. 17B illustrates an elongated barrel tray
1206' which it is closed, whereby the interior of the tray cannot
be viewed by the user 1206'. As shown in FIG. 17B, the barrel tray
1206' has a notch feature 1216', preferably triangular in
cross-section, on its distal end which receives the tension wire as
well as the tension head and through which the tension wire 102
passes while the tool is operating with the guidewire 100.
[0091] The tool 1200 shown in the embodiment in FIG. 17A also
includes a tension brace 1212 which is adjustably moveable along
the elongated tray 1206 between the tray's 1206 proximal and distal
ends 1208, 1210. In particular, the tension brace 1212 is
configured to retract toward the proximal end 1208 as the trigger
1204 is squeezed. In an embodiment, the tension brace 1212 freely
moves along the tray 1206 in response to actuation of the trigger
1204. In an embodiment, the tension brace 1212 is urged toward the
distal end 1210 by spring 1215. In this embodiment, a rod 1217 is
coupled at one end to a rotating cam of the trigger 1204 and
another end is coupled to the brace 1212, whereby actuation of the
trigger 1204 overcomes the forces on the tension brace 1212 by the
spring 1215 to move the tension brace 1212 toward the proximal end
1208.
[0092] In an embodiment, the notch feature 1216 is configured to
receive a portion of the tension wire 102 therethrough along with
the tension head 104 when the tension brace 1212. The tension brace
1212 is preferably positioned proximal to the collar rest 1210 and
has a tension head 104 engaging aperture. In an embodiment, the
tension brace 1212 has the head engaging aperture as described
above in FIG. 5A-5C or 6A-6C, and the details of the engaging
apertures are not discussed again herein. It should be noted that
other configurations of head engaging apertures are
contemplated.
[0093] In the embodiment in FIG. 17A, the tool 1200 includes a
magazine 1214 configured to house one or more of the cartridge
inserts described above. The magazine 1214 is shown preferably
coupled to and positioned below the elongated tray 1206, although
it is contemplated that the magazine may be positioned above or to
the side of the elongated tray 1206. FIG. 20 illustrates an broken
view of an interior of the cartridge magazine 1214 in accordance
with an embodiment. In general, the cartridge magazine 1214
preferably houses the cartridge prior to coupling the cartridge to
the tension wire 102 of the guidewire 100. In an embodiment, the
cartridge magazine 1214 additionally or alternately retrieves and
stores the cartridge after the cartridge has been coupled to the
tension wire 102. As shown in FIG. 19, the magazine 1214 preferably
includes a lifter mechanism 1220 positioned within the magazine
1214 along with a cartridge inserter 1222 which is coupled to the
lifter mechanism 1220.
[0094] As shown in FIGS. 19-21, the lifter mechanism 1220
preferably comprises one or more sets of scissor members 1228 which
are coupled to one another about an axis, whereby each scissor
member 1228 includes a roller 1232 on its end. The scissor members
1228 preferably move along a receiving groove along the bottom
surface 1234 of the magazine 1214 such that the rollers 1232 move
along only one dimension within the magazine 1214. Alternatively,
the scissor members 1228 move along a smooth surface within the
bottom surface 1234 of the magazine 1214. In operation, the rollers
1232 move along the bottom surface 1234 toward one another to cause
the lifter mechanism to move upward toward the tray 1206. In an
embodiment, the lifter mechanism 1220 preferably urges the
cartridge inserter 1222 to move in an upward direction by the use
of a spring. In another embodiment, a separate actuating control
(not shown) external to the magazine 1214 is used to selectively
cause the lifter mechanism 1220 to move upward and/or downward with
respect to the tray 1206. Such an actuating control may be a
mechanical and/or electronic switch, lever, button or other
actuating means. In an embodiment, the magazine 1214 is capable of
easily being disengaged from the tool 1200. This allows the
magazine 1214 to be reloaded with one or more cartridges, or be
replaced with an already full magazine which is then coupled to the
tool 1200.
[0095] As shown in FIGS. 20 and 21, the cartridge inserter 1222 has
a U-shaped configuration, whereby angled ends of the inserter 1222
preferably come into contact the sides 603 of the cartridge 600
(See FIG. 11) and allow the inserter 1222 to securely hold and move
the cartridge 600 to engage the wire 102. The magazine 1214 is
preferably positioned underneath the elongated tray 1206, whereby
the tray 1206 includes an aperture 1226 in communication with the
interior of the magazine 1214 as shown in FIG. 20. In an
embodiment, the aperture 1226 has a length dimension along the
elongated tray 1206 to allow specific sized cartridges to pass
therethrough. In an embodiment, the aperture 1226 has a length
dimension which traverses the entire length of the elongated tray
1206 to allow any sized cartridges to pass therethrough. The
aperture 1226 allows the cartridge 800 to be deployed within the
magazine in an upward direction to come in contact with and couple
to the tension wire 102 as the tension wire 102 is extended by the
tension brace 1212. In an embodiment, the aperture 1226 constantly
remains open in the elongated tray 1206. In an embodiment, the
aperture 1226 has a door which selectively opens to allow the
cartridge to be deployed around the tension wire 102.
[0096] In operation, as shown in FIG. 20, the user operates the
tool 1200 by placing the collar rest 1210 against the collar 108 of
the guidewire 100. The tensioning head 104 is inserted through the
notch feature 1216 and is then engaged and locked with the tension
brace 1212. The tension brace 1212 may have any of the engaging
apertures described above. The user then gradually applies force to
the trigger 1204 to cause the tension brace 1212 to gradually move
from the collar rest 1210 toward the handle 1202. As the tension
brace 1212 moves toward the proximal end of the tray 1206 the
tensioning wire 102 extends and thus causes the guidewire to
increase in stiffness. Once the tension brace 1212 moves away from
the aperture 1226 a desired distance, the lifter mechanism 1220
preferably automatically actuates to cause the scissor members 1228
to move toward one another and cause the cartridge holder 1222 as
well as a cartridge 600 to move upward through the aperture 1226
and around the tension wire 102. In an embodiment, the user
operates a separate actuator mechanism to cause the lifter
mechanism 1220 to operate. Preferably, the quick upward movement of
the inserter 1222 and cartridge 600 causes the cartridge 600 to
snap around the tension wire 102, as shown in FIG. 21.
[0097] As stated above, the cartridge 600, once deployed, will
maintain the tension of the guidewire. This allows the user to
depress the trigger, which causes the tension brace 1212 to move
back toward the distal end of the elongated tray 1206 and abut the
end of the cartridge 600. The tension head 104 is then disengaged
from the tension brace 1212. The tool 1200 is then preferably
removed from the guidewire 100 to allow surgical tools and/or drugs
to be delivered along the tensioned guidewire via the guidewire's
proximal end.
[0098] FIG. 22A illustrates a side view of a combined tensioning as
well as an cartridge applicator and removal tool in accordance with
an embodiment. As with the tool discussed in FIGS. 17-21, the tool
1300 includes a handle member 1302, a trigger member 1304, a
closed, barrel-shaped elongated tray 1306, a collar interface 1310,
and a tension brace 1312. As with the embodiment in FIG. 17A, the
handle member 1302 is designed to have a pistol grip and an
elongated trigger member 1304, although any other appropriate shape
for the handle 1302 and trigger member 1304 is contemplated.
[0099] As with the embodiment in FIG. 17A, the tool 1300 includes a
magazine 1314 positioned below the barrel tray 1306 and is
configured to deploy a cartridge around the tension wire 102 of the
guidewire 100 when the tension head 104 is extended a desired
distance from the collar interface 1310. As with the embodiment in
FIG. 17A, the barrel tray 1306 may include an aperture in its
bottom surface which is in communication with the interior of the
magazine 1314. As stated above, the magazine 1314, upon actuation,
moves the cartridge 600 upwards through the aperture in the bottom
surface of the barrel tray 1306. Upon the cartridge 600 coming in
contact with the tension wire 102, the cartridge 600 couples to the
tension wire 102 to prevent the tension wire 102 from reverting
back to the collar 108 or the relaxed default position of the
guidewire 100.
[0100] In the embodiment in FIG. 22A, the tool 1300 also includes a
removal magazine 1316 preferably positioned above the barrel tray
1306. The removal magazine 1316 houses a removal mechanism that is
configured to remove an already deployed cartridge 600 from the
tension wire 102 when the cartridge 600 is no longer needed. In an
embodiment, the removal magazine 1316 is in communication with an
aperture in the top surface of the barrel tray 1306 to allow the
cartridge 600 to be removed from the tray 1306 and moved into the
removal magazine 1316.
[0101] In the embodiment in FIG. 22A, the lifter mechanism 1318
preferably comprises one or more sets of scissor members 1320 which
are coupled to one another about an axis. In an embodiment, each
scissor member 1320 includes a roller 1322 on its end. The scissor
members 1320 preferably move along a receiving groove along the top
surface 1324 of the magazine 1316 such that the rollers 1322 move
along only one dimension within the magazine 1316. Alternatively,
the scissor members 1320 move along a smooth surface of the top
surface 1324 of the magazine 1316. In operation, the rollers 1322
move toward one another to cause the lifter mechanism to move
downward toward the barrel tray 1306. In an embodiment, the removal
mechanism 1318 preferably urges the cartridge remover 1326 to move
in a downward direction via a spring. In another embodiment, a
separate actuating control (not shown) external to the magazine
1316 is used to selectively operate the removal mechanism 1318 when
the user desires. Such an actuating control may be a mechanical
and/or electronic switch, lever, button or other actuating
means.
[0102] FIG. 22B illustrates an end view of the tool 1300 with
removal mechanism 1318 in accordance with an embodiment. The insert
magazine 1314 is not shown in FIG. 22B for clarity purposes. In an
embodiment, the cartridge remover 1326 has a similar
cross-sectional shape to the inserter 1222 shown in FIGS. 20 and 21
in which the remover 1326 has a U-shaped configuration with angled
ends. The ends of the remover 1326 come into contact with the
slightly angled faces 601 of cartridge 600, whereby the pointed
ends press against the faces 601, as shown in FIG. 22B. As the ends
of the remover 1326 press against the faces 601, the forces cause
the faces 601 to the bend downward and outward with respect to the
aperture 606. Upon sufficient force being applied to the faces 601,
the movement of the faces 601 away from one another causes the
diameter of the aperture 606 to slightly increase, thereby allowing
the cartridge 600 to slip off of the tension wire 102, thereby
disengaging the cartridge 600 from the wire 102.
[0103] It should be noted that although an example is shown and
described as to the construction of the removal mechanism, any
appropriate construction which allows the cartridge remover 1326 to
move to the barrel tray 1306 and remove the cartridge 800 is
contemplated. It should be noted that although the figure shows two
separate magazines, one for insertion and one for removal of the
cartridge, is contemplated that one magazine may be used to perform
both insertion and removal functions in an embodiment. It should
also be noted that although the cartridge 600 is discussed in
relation with the embodiments in FIGS. 19-22B, any other shaped
cartridge may be used as a substitute with appropriately modified
inserter and/or remover devices.
[0104] In an embodiment, the magazine 1318 is capable of easily
being disengaged from the tool 1300. This allows one or more
cartridges collected by the magazine to be unloaded from the tool
1300. In an embodiment, the detaching feature allows a magazine
full of used cartridges to be replaced with an empty removal
magazine for continuing use. In an embodiment, the removal magazine
1318 includes one or more windows (not shown) to allow the user to
view inside the magazine 1318 and see the collected cartridges or
an aperture for the ejection of spent or used cartridges.
[0105] FIG. 23A illustrates a perspective view of a guidewire with
integrated tension maintaining mechanism in accordance with an
embodiment. As shown in FIG. 23A, the guidewire 1400 preferably
includes a body 1406 having a tension wire 1402 and a tension head
1404 coupled to a proximal end of the tension wire 1402.
[0106] The body 1406 has a diameter D, whereby the tension wire
1402 has a diameter d.sub.w, and the tension head 1404 has a width
dimension w.sub.h. The diameter d.sub.w of the tension wire 1402 is
preferably smaller than the diameter D of the body 1406.
Additionally, it is preferred that the width w.sub.h of the tension
head 1404 is greater than the diameter d.sub.w of the tension wire
1402 but preferably smaller than the diameter D of the body 1406.
The smaller width dimension w.sub.h of the tension head 1404 allows
the user to load and unload other surgical tools via the head 1404
and onto the coil body 1406 while simultaneously maintaining the
desired stiffness of the guidewire 1400.
[0107] The tension head 1404 has an integrated tension maintaining
mechanism 1410 in which the mechanism 1410 includes one or more
channels which are configured to house tensioning legs, as shown in
FIG. 23A. In the embodiment shown in FIG. 23A, the tension
maintaining mechanism 1410 includes channels 1412, 1414 and 1416,
each preferably located near the angles of the triangular head
1404, although placement of the channels can be anywhere on the
head 1404. In an embodiment, the channels 1412, 1414 and 1416
extend entirely through the tension head, whereby one or more of
the channels 1412, 1414 and 1416 have an aperture in surface 1432
and opposing surface 1434. In an embodiment, the channels 1412,
1414 and 1416 only extend out of surface 1434 of the tension head
1404.
[0108] The channels 1412, 1414 and 1416 preferably house respective
tension legs 1418, 1420, 1422 which are slidably moveable in and
out of the channels in a linear direction. Each tension leg has a
proximal end which preferably remains attached to the tension head
1404 and a distal end which comes in contact and abuts the collar
1408 of the guidewire 1400. When in the retracted mode, as with
legs 1420, 1422 in FIG. 23A, the legs 1420, 1422 remain within
their respective channels 1420, 1422 and preferably do not come
into contact with the collar 1408. In contrast, when the leg is in
the extended mode, as with tension leg 1418, the leg 1418 abuts the
collar 1408 and forces the tension head 1404 to remain positioned
away from the collar 1408 to ensure that the guidewire maintains
its desired stiffness. In an embodiment, it is contemplated that
the collar 1408 may include one or more detents 1430 which are
configured to receive the distal end of the respective tension leg.
The detents 1430 aid in stabilizing the tension leg in the extended
position and prevent the tension leg from slipping off the surface
of the collar 1408.
[0109] In an embodiment in which the mechanism 1410 utilizes more
than one tension leg, it is preferred that the tension legs have
different length dimensions, although this is optional. As shown in
FIG. 23A, tension leg 1420 has a greater length dimension compared
to leg 1422, but a smaller length dimension than leg 1418.
Considering that the stiffness of the guidewire 1400 is directly
proportional to the distance between the tension head 1404 and the
collar 1408, the guidewire 1400 will experience greater stiffness
when tension leg 1418 is in the extended position than when tension
leg 1420 is in the extended position. In comparison, the guidewire
1400 will experience less stiffness when tension leg 1422 is in the
extended position than when tension leg 1420 is in the extended
position. This allows the user to selectively choose which tension
leg to utilize based on the desired stiffness of the guidewire
1400.
[0110] The tension legs 1418, 1420, 1422 are preferably attached to
the channels at their proximal ends to prevent the legs 1418, 1420,
1422 from becoming disengaged from the tension head 1404. The
mechanism 1410 is configured to ensure that the extended tension
leg is able to withstand the forces which urge the tension head
1404 to move toward the collar 1408. In an embodiment, a spring
(not shown) within the tension head 1404 urges the tension leg to
the extended position, whereby the spring is rated with a constant
k such that the spring force will be higher than any opposite force
that urges head 1404 and collar 1408 toward one another.
[0111] In an embodiment, FIG. 23B, an actuator 1424 which is
attached to leg 1418 protrudes out of an elongated aperture 1426 in
the tension head 1404, whereby the user can slidably move the
actuator 1424 along an elongated aperture 1426 to slide the leg
1418 in or out of the head 1404. As shown in FIG. 23B, the
elongated aperture 1426 includes a stop detent 1428 in which the
actuator 1424 may be set to ensure that the leg 1418 remains in the
extended position to maintain the stiffness in the guidewire 1400.
In the example shown in FIG. 23B, the stop detent 1428 is
positioned at the end of the window 1426 closest to the tension
wire 1402, although one or more intermediate stop detents may be
configured at desired locations along the elongated aperture 1426
to allow the user to achieve various intermediate lengths of the
tension leg (and associated stiffness from the guidewire) by
locking the actuator 1424 in any of the desired intermediate
detents.
[0112] In an embodiment, the tension head 1404 is configured to be
rotatable about an axis oriented along the length of the tension
wire 1402. This would allow the user to simply rotate the tension
head 1404 to a desired position which may be less cumbersome for
the user to extend or retract a tension leg based on the
orientation of the guidewire 1400 during a procedure.
Alternatively, the tension head 1404 is not rotatable about the
tension wire 1402 and is fixedly coupled thereto.
[0113] In an embodiment, the integrated guidewire tension
maintaining head may be combined with a tool to actuate the tension
legs. FIG. 24 illustrates a side view of the integrated guidewire
tension maintaining head 1400 with deployment tool 1500 in
accordance with such an embodiment. The deployment tool 1500
preferably includes a handle member 1502, a trigger member 1504, an
elongated tray 1508, a tension brace 1506, and a collar interface
1510. Although the handle member 1502 is shown to have a pistol
grip and an elongated trigger member 1504, other appropriate shapes
for the handle 1502 and/or trigger member 1504 are
contemplated.
[0114] As shown in FIG. 24, the tension head 1404 is positioned
within the deployment tool 1500 between the handle 1502 and the
tension brace 1506. The handle 1502 preferably includes an
actuating pin 1512 positioned within a chamber 1514 therein,
whereby the pin 1512 preferably extends out of the handle 1502 when
the trigger 1504 is depressed. The tool 1500 preferably includes an
aperture 1516 on the handle 1502 which is in communication with the
pin chamber 1514. In an embodiment, the aperture 1516 is aligned
with a receiving aperture 1436 of the tension head 1404 such that
the pin 1512, upon being actuated, extends out of the chamber 1514
passes through aperture 1436 to press the tension leg 1418 out of
channel 1412. As stated above, the tension leg 1418 extends out of
head 1404 to the extended position in which the leg 1418 abuts the
collar 1408.
[0115] In the embodiment in FIG. 24, the tension leg 1418 separates
the distance between the tension head 1404 and the collar 1408. It
is contemplated that the tension brace 1506 may aid in separating
the tension head 1404 from the collar 1408 in that a combination of
the tension brace 1506 and tension leg 1418 maintain stiffness of
the guidewire. The tension brace 1506 preferably includes an
aperture which is aligned with the exit aperture 1438 of the
tension head 1404 such that the tension leg 1418 passes through the
tension brace 1506 and abuts the collar interface 1510.
[0116] As stated, the tension head 1404 is rigidly attached to the
tension wire 1402 and guidewire body 1406. In an embodiment, the
tension head 1404 is rigidly attached to the deployment tool 1500.
In an embodiment, the tension head 1404 is not rigidly attached to
the deployment tool 1500, whereby the deployment tool 1500 may be
used with different classes of guidewires having differently
dimensioned tension heads and/or tension legs.
[0117] It should be noted that the tension head 1404 is shown in
FIGS. 23 and 24 have a triangular shape. Although this is a
preferred shape, the tension head 1404 may alternatively have any
other shape including, but not limited to, square, hexagonal,
pentagonal, trapezoidal, spherical, circular, etc. It should be
noted that the tension legs are shown in the Figures as
bean-shaped, the tension legs may have any cross sectional shape,
such as square, circular, rectangular, etc. Although three channels
and tension legs are described above, it should be noted that any
number of channels and tension legs, such as one channel or leg,
are contemplated for a particular tension head.
[0118] While embodiments and applications have been shown and
described, it would be apparent to those skilled in the art having
the benefit of this disclosure that many more modifications than
mentioned above are possible without departing from the inventive
concepts disclosed herein. The invention, therefore, is not to be
restricted except in the spirit of the appended claims.
* * * * *