U.S. patent application number 14/244134 was filed with the patent office on 2016-06-02 for anchoring guidewire and methods for use.
This patent application is currently assigned to Sanford Health. The applicant listed for this patent is Sanford Health. Invention is credited to Patrick W. Kelly.
Application Number | 20160151182 14/244134 |
Document ID | / |
Family ID | 54208737 |
Filed Date | 2016-06-02 |
United States Patent
Application |
20160151182 |
Kind Code |
A9 |
Kelly; Patrick W. |
June 2, 2016 |
Anchoring Guidewire and Methods for Use
Abstract
An anchoring guidewire and methods for use, where the anchoring
guidewire comprises: (a) an outer core, (b) an anchoring basket,
(c) a steerable tip, and (d) an actuator core. The outer core, the
anchoring basket and the steerable tip are axially aligned with one
another. Further, the actuator core may be movably disposed within
both the outer core and the anchoring basket and may be coupled to
the steerable tip.
Inventors: |
Kelly; Patrick W.; (Sioux
Falls, SD) |
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Applicant: |
Name |
City |
State |
Country |
Type |
Sanford Health |
Sioux Falls |
SD |
US |
|
|
Assignee: |
Sanford Health
Sioux Falls
SD
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20150282966 A1 |
October 8, 2015 |
|
|
Family ID: |
54208737 |
Appl. No.: |
14/244134 |
Filed: |
April 3, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61809134 |
Apr 5, 2013 |
|
|
|
Current U.S.
Class: |
623/1.23 |
Current CPC
Class: |
A61M 2025/09125
20130101; A61M 25/04 20130101; A61M 25/09 20130101; A61F 2/954
20130101 |
International
Class: |
A61F 2/954 20060101
A61F002/954 |
Claims
1. An anchoring guidewire, comprising: an outer core; an anchoring
basket; a steerable tip; and an actuator core, wherein the outer
core, the anchoring basket and the steerable tip are axially
aligned with one another, wherein the actuator core is movably
disposed within both the outer core and the anchoring basket,
wherein the actuator core is coupled to the steerable tip.
2. The anchoring guidewire of claim 1, wherein the anchoring basket
comprises a plurality of strips defined in the outer core adjacent
to the steerable tip, wherein the plurality of strips are
substantially straight in a first neutral state and bow out in a
radial direction in a second compressed state.
3. The anchoring guidewire of claim 1, wherein the anchoring basket
comprises a plurality of wires each with a proximal end and a
distal end, wherein each proximal end of the plurality of wires is
attached to a first holder and each distal end of the plurality of
wires is attached to a second holder, wherein the plurality of
wires are substantially straight in a first neutral state and bow
out in a radial direction in a second compressed state.
4. The anchoring guidewire of claim 3, wherein the first holder is
in mechanical communication with the outer core and the second
holder is in mechanical communication with the steerable tip.
5. The anchoring guidewire of claim 2, wherein the actuator core is
positioned to allow it to cause the anchoring basket to move
between the first neutral state and the second compressed
state.
6. The anchoring guidewire of claim 2, wherein the actuator core is
positioned to allow it to cause the steerable tip to advance
towards the outer core until the anchoring basket is in the second
compressed state.
7. The anchoring guidewire of claim 3, wherein the actuator core is
positioned to allow it to cause the second holder to advance
towards the first holder until the anchoring basket is in the
second compressed state.
8. The anchoring guidewire of claim 2, wherein the actuator core is
in mechanical communication with a releasable locking mechanism
configured to hold the anchoring basket in the second compressed
state.
9. The anchoring guidewire of claim 3, wherein in the second
compressed state, the second holder is positioned to allow it to
cause the steerable tip to advance away from the outer core until
the first neutral state is achieved.
10. The anchoring guidewire of claim 1, wherein the actuator core
has a stiffness such that the actuator core is capable of both
pushing and pulling the steerable tip.
11. The anchoring guidewire of claim 2, wherein the anchoring
basket has a diameter in the second compressed state ranging from
about 3 mm to about 70 mm.
12. The anchoring guidewire of claim 1, wherein the steerable tip
has a length in the range from about 5 mm to about 200 mm.
13. The anchoring guidewire of claim 1, wherein the outer core has
a diameter in the range from about 0.254 mm to about 0.9652 mm.
14. The anchoring guidewire of claim 1, wherein the length of the
anchoring guidewire ranges from about 120 mm to about 10,000
mm.
15. The anchoring guidewire of claim 1, wherein a plurality of
radiopaque markers are disposed on the outer core.
16. The anchoring guidewire of claim 1, wherein the plurality of
radiopaque markers are arranged such that the plurality of
radiopaque maker are spaced apart by 1 cm starting at a proximal
end of the anchoring basket and moving in a proximal direction up
to about 20 mm along the outer core.
17. A method for deploying an anchoring guidewire, the method
comprising: introducing the anchoring guidewire according to claim
1 into an arterial configuration; placing the actuator core under
tension and causing the steerable tip to advance towards the outer
core; and moving the anchoring basket from a first neutral state to
a second compressed state.
18. The method of claim 17, further comprising the steps of:
removing tension from the actuator core; and moving the anchoring
basket from a second compressed state to a first neutral state.
19. The method of claim 17, further comprising the step of: locking
the actuator core in place to hold the anchoring basket in the
second compressed state.
20. The method of claim 19 further comprising the step of:
unlocking the actuator core.
Description
RELATED APPLICATIONS
[0001] This application is a non-provisional of and claims priority
to U.S. Provisional Application No. 61/809,134 entitled "Anchoring
Guidewire," filed on Apr. 5, 2013, which is hereby incorporated by
reference in its entirety.
BACKGROUND OF THE INVENTION
[0002] Guidewires may be utilized to direct medical devices into a
desired target vessel for intervention. Conventional guidewire
methods and devices may include a steerable guidewire that is not
anchored in any way. When tortuous anatomies are involved, the
stiff device may work to straighten the guide wire as the device is
advanced over the curved portion of the guide wire and the
steerable guidewire may often slip back out of the target vessel
making it difficult to use the steerable guidewire as a coaxial
rail to guide a device into the appropriate vessel.
SUMMARY OF THE INVENTION
[0003] The present invention is directed to methods and apparatus
that may include an anchoring basket to anchor a guidewire to
vasculature prior to graft deployment. These features may thereby
improve the ease by which stent grafts can be placed in branched
vessels and increase the speed and success of complex cases, while
at the same time lowering the chance for complications. Anchoring
the guidewire to the subject's vasculature may have a stabilizing
effect for the tip of the catheter and afford greater stability and
confidence for the operator. Once the anchoring basket is deployed
it may be locked in place, securing the basket and may beneficially
allow blood to continue to flow through the basket and downstream.
Once anchored, the guidewire may be used as a common coaxial rail
for improved delivery of treatment devices such as bare metal
stents, covered stents, and other over-the-wire devices.
[0004] Thus, in a first aspect, the present invention provides an
anchoring guidewire comprising: (a) an outer core, (b) an anchoring
basket, (c) a steerable tip, and (d) an actuator core, where the
outer core, the anchoring basket and the steerable tip are axially
aligned with one another, and where the actuator core is movably
disposed within both the outer core and the anchoring basket, and
where the actuator core is coupled to the steerable tip.
[0005] In one embodiment, the invention may provide that the
anchoring basket comprises a plurality of strips defined in the
outer core adjacent to the steerable tip, where the plurality of
strips are substantially straight in a first neutral state and bow
out in a radial direction in a second compressed state.
[0006] In another embodiment, the invention may provide that the
anchoring basket comprises a plurality of wires each with a
proximal end and a distal end, where each proximal end of the
plurality of wires is attached to a first holder and each distal
end of the plurality of wires is attached to a second holder, where
the plurality of wires are substantially straight in a first
neutral state and bow out in a radial direction in a second
compressed state.
[0007] In a second aspect, the present invention also provides a
method for deploying an anchoring guidewire, the method comprising:
(a) introducing the anchoring guidewire according to the first
aspect of the invention into an arterial configuration, (b) placing
the actuator core under tension and causing the steerable tip to
advance towards the outer core, and (c) moving the anchoring basket
from a first neutral state to a second compressed state.
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1A is a side view of the anchoring guidewire in a
neutral state, in accordance with one embodiment of the
invention.
[0009] FIG. 1B is a side view of the anchoring guidewire in a
compressed state, in accordance with one embodiment of the
invention.
[0010] FIG. 2A is a side view of a locking mechanism in a neutral
state, in accordance with one embodiment of the invention.
[0011] FIG. 2B is a side view of a locking mechanism in a
compressed state, in accordance with one embodiment of the
invention.
[0012] FIG. 2C is a side view of a locking mechanism in a locked
state, in accordance with one embodiment of the invention.
[0013] FIG. 3 is a flow chart depicting functions that can be
carried out in accordance with example embodiment of the disclosed
methods.
DETAILED DESCRIPTION OF THE INVENTION
[0014] Exemplary methods and systems are described herein. It
should be understood that the word "exemplary" is used herein to
mean "serving as an example, instance, or illustration." Any
embodiment or feature described herein as "exemplary" is not
necessarily to be construed as preferred or advantageous over other
embodiments or features. The exemplary embodiments described herein
are not meant to be limiting. It will be readily understood that
certain aspects of the disclosed systems and methods can be
arranged and combined in a wide variety of different
configurations, all of which are contemplated herein.
[0015] Furthermore, the particular arrangements shown in the
Figures should not be viewed as limiting. It should be understood
that other embodiments may include more or less of each element
shown in a given Figure. Further, some of the illustrated elements
may be combined or omitted. Yet further, an exemplary embodiment
may include elements that are not illustrated in the Figures.
[0016] In a first aspect, as shown in FIGS. 1A-B, the present
invention may take the form of an anchoring guidewire 100
comprising: (a) an outer core 102, (b) an anchoring basket 104, (c)
a steerable tip 106, and (d) an actuator core 108. The outer core
102, the anchoring basket 104 and the steerable tip 106 may be
axially aligned with one another. Further, the actuator core 108
may be movably disposed within both the outer core 102 and the
anchoring basket 104 and may be coupled to the steerable tip 106.
The total length of the anchoring guidewire 100 may range from
about 120 mm to about 10,000 mm.
[0017] As used herein, with respect to measurements and
calculations, "about" means .+-.5%.
[0018] The outer core 102 may be made of, for example,
polyurethane, a polyurethane with tungsten, gold, nitinol,
platinum, stainless steel, stainless steel with nickel, tungsten or
any other suitable material. The outer core 102 may have a diameter
in the range from about 0.25 mm to about 1 mm, and preferably in
the range from about 0.254 mm to about 0.9652 mm. In some
embodiments, a plurality of radiopaque markers may be disposed on
the outer core 102. This plurality of radiopaque markers may be
arranged such that the plurality of radiopaque makers are spaced
apart by 1 cm, for example, starting at the proximal end of the
anchoring basket 104 and moving in a proximal direction in a range
up to about 20 mm along the outer core 102.
[0019] In one embodiment, the anchoring basket 104 may include a
plurality of strips defined in the outer core 102 adjacent to the
steerable tip 106. These strips may be created by laser cutting the
outer core 102. The strips may be substantially straight in a first
neutral state (as shown in FIG. 1A) and may bow out in a radial
direction in a second compressed state (as shown in FIG. 1B).
[0020] In another embodiment, the anchoring basket 104 may include
a plurality of wires each with a proximal end and a distal end.
This plurality of wires may be made of, for example, nitinol,
titanium, titanium alloys, various plastics or any other suitable
material. In one embodiment, each proximal end of the plurality of
wires may be attached to a first holder 110 and each distal end of
the plurality of wires may be attached to a second holder 112. In
an alternative embodiment, the plurality of wires may be coupled
directly to the outer core 102 and to the steerable tip 106. The
plurality of wires may be substantially straight in a first neutral
state (as shown in FIG. 1A) and bow out in a radial direction in a
second compressed state as the first holder 110 and second holder
112 are moved closer to one another (as shown in FIG. 1B). The
anchoring basket 104 may have a diameter in the second compressed
state ranging from about 3 mm to about 70 mm. The first holder 110
may be in mechanical communication with the outer core 102 and the
second holder 112 may be in mechanical communication with the
steerable tip 106. In some embodiments, the outer core 102 may be
physically coupled to the first holder 110 and the steerable tip
106 may likewise be physically coupled to the second holder
112.
[0021] The actuator core 108 may be movably disposed within the
outer core 102 and extend through the anchoring basket 104 such
that the actuator core 108 may be coupled to the steerable tip 106
and/or the second holder 112. In operation, the actuator core 108
may cause the anchoring basket 104 to move between the first
neutral state and the second compressed state. FIG. 1A illustrates
the first neutral state of the anchoring guidewire 100, and FIG. 1B
illustrates the second compressed state of the anchoring guidewire
100. In one embodiment, the actuator core 108 may be positioned to
allow it to cause the steerable tip 206 to advance towards the
outer core 102 until the anchoring basket 104 is in the second
compressed state. In another embodiment, the actuator core 108 may
be positioned to allow it to cause the second holder 112 to advance
towards the first holder 110 until the anchoring basket 104 is in
the second compressed state.
[0022] FIGS. 2A-2C illustrate an example locking mechanism in
accordance with one embodiment of the invention. Specifically, the
actuator core 108 may be in physical communication with a
releasable locking mechanism to hold the anchoring basket 104 in
the second compressed state. As shown in FIG. 2A, the releasable
locking mechanism may include a raised element or protrusion 114
coupled to the actuator core 108. In the first neutral state, the
raised element or protrusion 114 may be configured to fit within a
slot 116 in the outer core 102. As shown in FIGS. 2B-2C, as the
anchoring guidewire 100 moves from the first neutral state to the
second compressed state, the actuator core 108 and thereby the
raised element 114 may be pulled in a proximal direction relative
to the outer core 102, then rotated such that an interference fit
(shown in FIG. 2C) with the outer core 102 prevents the raised
element 114 from moving distally. The net result of this is that
the actuator core 108 may be locked in position and hold the
anchoring basket 104 in the second compressed state. When the
plurality of wires 105 of the anchoring basket 104 are in the
second compressed state, the wires 105 are spring-loaded such that
they seek to return to the first neutral state. As such, when a
tension in the actuator core 108 is removed, the second holder 112
is positioned to allow it to cause the steerable tip 106 to advance
away from the outer core 102 until the first neutral state is
achieved.
[0023] In one embodiment, the actuator core 108 may have a
stiffness such that the actuator core 108 may be capable of both
pushing and pulling the steerable tip 106. Here, the actuator core
108 and/or the spring force in the plurality of wires may cause the
wire anchor basket 104 to return to the first neutral state.
[0024] The steerable tip 106 may have various stiffness and
thickness to account for different use cases. For example, the
steerable tip 106 may be thinner and/or less stiff in a case where
the anchoring guidewire 100 must navigate a tight turn to advance
to the target vessel. In another example, the steerable tip 106 may
be thicker and/or stiffer in a case where the target vessel is less
delicate and there is a more direct route to the target vessel. The
steerable tip 206 may have a length in the range from about 5 mm to
about 200 mm.
[0025] FIG. 3 is a simplified flow chart illustrating a method
according to an exemplary embodiment. Although the blocks are
illustrated in a sequential order, these blocks may also be
performed in parallel, and/or in a different order than those
described herein. Also, the various blocks may be combined into
fewer blocks, divided into additional blocks, and/or removed based
upon the desired implementation.
[0026] At block 302, the method involves introducing the anchoring
guidewire according to any one of the foregoing embodiments into
any appropriate arterial configuration, including a synthetic
lumen. At block 304 the method involves placing the actuator core
under tension and causing the steerable tip to advance towards the
outer core. At block 306, the method involves moving the anchoring
basket from a first neutral state to a second compressed state. At
block 308, the method involves locking the actuator core in place
to hold the anchoring basket in the second compressed state. The
actuator core may be locked in place using the example locking
mechanism described above in relation to FIGS. 2A-2C, or through
some other locking mechanism. In another embodiment, the method may
further include the step of unlocking the actuator core. In still
another embodiment, the method may further include removing tension
from the actuator core and moving the anchoring basket from the
second compressed state to the first neutral state.
[0027] While various aspects and embodiments have been disclosed
herein, other aspects and embodiments will be apparent to those
skilled in the art. All embodiments within and between different
aspects of the invention can be combined unless the context clearly
dictates otherwise. The various aspects and embodiments disclosed
herein are for purposes of illustration and are not intended to be
limiting, with the true scope and spirit being indicated by the
following claims.
* * * * *