U.S. patent application number 10/188929 was filed with the patent office on 2003-01-09 for torqueable soft tip medical device and method of usage.
This patent application is currently assigned to PRECISION VASCULAR SYSTEMS, INC.. Invention is credited to Davis, Clark C., Snyder, Edward J., Turnlund, Todd H..
Application Number | 20030009208 10/188929 |
Document ID | / |
Family ID | 23168790 |
Filed Date | 2003-01-09 |
United States Patent
Application |
20030009208 |
Kind Code |
A1 |
Snyder, Edward J. ; et
al. |
January 9, 2003 |
Torqueable soft tip medical device and method of usage
Abstract
A medical device or intravascular device, and methods of use.
The devices may be tubular and may have a flexible polymer tip The
body may be nitinol and may have cuts part way through along its
length to facilitate bending The device may have a liner which may
extend through the tip or form the tip The device may have markers
readily visible on an X-ray viewer during insertion. The tip may
have an anti-collapsing structure and may be shaped before use to
perform a medical procedure such as treating an aneurysm. The
device may have a strong fiber through it for complete removal. The
method may include selecting the device, bending the tip, setting
the shape, and inserting the device into the patient's anatomy. The
shape of the tip may be set by heating with steam and then removing
a mandrel.
Inventors: |
Snyder, Edward J.; (Park
City, UT) ; Davis, Clark C.; (Holladay, UT) ;
Turnlund, Todd H.; (Park City, UT) |
Correspondence
Address: |
SNELL & WILMER
ONE ARIZONA CENTER
400 EAST VAN BUREN
PHOENIX
AZ
850040001
|
Assignee: |
PRECISION VASCULAR SYSTEMS,
INC.
WEST VALLEY CITY
UT
|
Family ID: |
23168790 |
Appl. No.: |
10/188929 |
Filed: |
July 3, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60302685 |
Jul 5, 2001 |
|
|
|
Current U.S.
Class: |
607/116 |
Current CPC
Class: |
A61M 25/0052 20130101;
A61M 25/0051 20130101; A61M 25/0054 20130101; A61M 25/0138
20130101; A61M 25/0053 20130101; A61M 2025/0081 20130101; A61M
25/005 20130101 |
Class at
Publication: |
607/116 |
International
Class: |
A61N 001/05 |
Claims
What is claimed is:
1. A medical device comprising: a body having a proximal end and a
distal end, said body having a plurality of cuts part way through
said body; and a tip extending from said distal end of said body,
said tip substantially comprising a non-metallic material
2. The device of claim 1, said tip being more flexible in bending
than said body.
3. The device of claim 1: said tip having a length that is greater
than one millimeter; and said tip having a length that is less than
1500 millimeters.
4. The device of claim 1: said tip having a length that is greater
than 10 millimeters, and said tip having a length that is less than
40 millimeters
5. The device of claim 1: said tip having an outside diameter that
is greater than 0.01 inches; and said tip having an outside
diameter that is less than 0.5 inches.
6. The device of claim 1: said tip having an outside diameter that
is greater than 0.030 inches; and said tip having an outside
diameter that is less than 0 040 inches.
7. The device of claim 1: said tip having an outside diameter that
is greater than 0.020 inches; and said tip having an outside
diameter that is less than 0 030 inches.
8. The device of claim 1: said tip having an outside diameter that
is greater than 0 015 inches; and said tip having an outside
diameter that is less than 0.025 inches.
9. The device of claim 1, said tip being configured to be custom
shaped by a person who will operate said device to perform a
medical procedure.
10. The device of claim 1, said body being substantially comprised
of metal.
11. The device of claim 10, said metal being super-elastic
nitinol
12. The device of claim 1: said body being substantially tubular;
and the device further comprising a substantially tubular liner
13. The device of claim 12: said liner extending at least from said
proximal end to said distal end; and said liner further extending
distal to said body.
14. The device of claim 13, said tip substantially comprising said
liner.
15. The device of claim 13, said liner being inside said body.
16. The device of claim 13: said tip further comprising a
substantially tubular end sleeve; and said end sleeve substantially
comprising polymer.
17. The device of claim 16: said end sleeve having a distal end;
said liner terminating substantially proximal to said distal end of
said end sleeve.
18. The device of claim 1: further comprising a substantially
tubular liner and said body being inside said liner
19. The device of claim 1: said body being substantially tubular;
the device further comprising a first liner and a second liner;
said first liner being inside said body; and said body being inside
said second liner.
20. The device of claim 19. said device further having an end
sleeve; said end sleeve being between said first liner and said
second liner.
21. The device of claim 1, said tip further comprising an
anti-collapsing structure.
22. The device of claim 21, said anti-collapsing structure
comprising at least one groove.
23. The device of claim 21, said anti-collapsing structure
comprising a coil
24. The device of claim 21: said anti-collapsing structure
comprising a coil; and said coil being at least partially in a
groove.
25. The device of claim 21, said anti-collapsing structure
comprising a braid.
26. The device of claim 1, said device comprising at least one
marker.
27. The device of claim 1, said device comprising two markers.
28. A medical device having a tensile strength, the device
comprising: a body having a proximal end and a distal end, said
body having a plurality of cuts part way through said body, and a
fiber extending through said body, said fiber being configured to
increase the tensile strength of the device.
29. The device of claim 28, said fiber substantially comprising one
or more materials selected from the group consisting of: polymers,
metals, carbon fibers, and ceramic fibers.
30. The device of claim 28: the device further comprising at least
one substantially tubular liner; said liner extending from said
proximal end at least to said distal end; said fiber being located
between said body and said liner.
31. The device of claim 30, said fiber being arranged substantially
in a zigzag configuration.
32. A method of treating a patient with a tubular medical device,
the patient having anatomy, the method comprising the steps of:
selecting a medical device, the device having a flexible tip;
shaping the tip, said shaping comprising bending, and inserting the
device into the anatomy, said inserting comprising axially
translating the device, rotating the device, and monitoring the
distal end.
33. The method of claim 32, the device having: a body having a
proximal end and a distal end, the body having a plurality of cuts
part way through the body; and the tip extending from the distal
end of the body, the tip substantially comprising a non-metallic
material.
34. The method of claim 32 further comprising the step, after said
shaping, of setting the shape of the tip.
35. The method of claim 34 said setting the shape comprising
heating the tip.
36. The method of claim 32 the device being substantially tubular
and comprising at least one substantially tubular liner, the liner
extending from the proximal end to the distal end.
37. The method of claim 32, the device being substantially tubular,
the method further comprising the step, after said shaping, of
removing a mandrel from the tip.
38. The method of claim 32 further comprising the step, after said
inserting, of performing a medical procedure using the device.
39. The method of claim 39, the procedure comprising treating an
aneurysm.
40. The method of claim 32, the tip having at lest one marker, said
monitoring comprising observing the marker
41. The method of claim 32, further comprising the step of removing
the device, the device having a fiber running substantially through
the device, the fiber being configured to assure complete removal
of the device.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims priority to U.S. Provisional
Application Serial No. 60/302,685, filed Jul. 5, 2001, entitled
"Catheter Guidewire Apparatus."
FIELD OF INVENTION
[0002] This invention relates generally to flexible medical devices
and methods of using them.
BACKGROUND OF THE INVENTION
[0003] Medical devices such as endovascular or intravascular
devices have been used for many years for purposes such as
performing medical procedures, including treating aneurysms. A
medical device such as an intravascular device may be introduced
into a patient's anatomy or vasculature at a relatively accessible
location, and guided through the patient's anatomy to the desired
location. X-ray fluoroscopy has been used to observe the tip of the
medical device and the device has been rotated at bifurcations in
the anatomy or vasculature before being pushed further to guide the
device to the desired location. Medical devices of this type may be
solid, for example, a guide wire, or may be hollow and tubular, for
example, a catheter Guide wires may be used to guide one or more
tubular intravascular devices to a particular location, and
catheters may be used, for instance, to deliver fluids, extract
fluids, or deliver various objects, agents, or devices to the
particular location.
[0004] In many applications it is desirable that a medical device
or intravascular device bend easily in order to allow it to make
the various bends and turns that are necessary to navigate through
the anatomy or vasculature, and in some cases also to minimize
trauma to the anatomy or vasculature. However, in many applications
it is desirable that the medical device be relatively stiff in
torsion in order to allow precise control of rotation in order to
guide the device through bifurcations in vasculature or around
obstacles. Accordingly, medical and intravascular devices have been
described that contain numerous cuts along their length to obtain
the desired flexibility in bending while maintaining relative
stiffness in torsion. Examples of such devices are described in
U.S. Pat. Nos. 5,690,120 and 5,833,632, both of which are
incorporated herein by reference in their entirety. An example of a
method of making such devices is described in U.S. Pat. No.
6,260,485 B1, which is also incorporated herein by reference in its
entirety.
[0005] In many applications, it is desirable that the tip of a
medical device be soft and bendable so as to minimize trauma to the
patient's anatomy and further facilitate negotiating bends and
turns in the anatomy or vasculature. Thus, a need exists for such a
soft and bendable tip. In addition, the tip of a medical device may
be bent or curved so that when the device approaches a bifurcation,
or other location where direction needs to be selected, the device
may be steered in the correct direction. In the past, tips were
bent or curved during initial fabrication of the device. However,
in at least some applications, a greater or lesser curvature may be
desirable. Accordingly, a need exists for a device wherein the
angle or radius of bending or curvature of the tip may be selected
by the operator of the medical device, for instance, by the medical
doctor performing a medical procedure with the medical device.
[0006] Furthermore, in many applications, it is desirable and
important that the entire device be removed after the procedure is
completed. Thus, it is desirable that the device have a strong and
reliable tensile strength throughout its length so that it does not
come apart when pulled out of the patient's anatomy or vasculature.
Accordingly, a need exists to improve and provide redundancy in the
tensile strength of a medical device to assure complete removal of
the device.
SUMMARY OF THE INVENTION
[0007] The present invention provides medical devices including
intravascular devices and methods of using medical devices and
intravascular devices. Medical devices in accordance with the
present invention may be, for example, a guide wire that may be
hollow. Features and objects of various embodiments of the present
invention include that the devices are flexible in bending, the
devices and methods minimize trauma to the patient's anatomy, and
the devices and methods assure complete removal of the medical
device.
[0008] Accordingly, in at least partial fulfillment of these
objects, an exemplary embodiment of the present invention includes
a medical device that may be an intravascular device, that has a
body with a proximal end and a distal end. The body may have a
plurality of cuts part way through. The device may also have a tip
extending from the distal end of the body, which may be
substantially made of a non-metallic material. The tip may be more
flexible in bending than the body, and may be configured to be
custom shaped by the person who will operate the device. The body
may be substantially comprised of metal, which may be super-elastic
nitinol. The body may be substantially tubular, and may have at
least one substantially tubular liner. The liner may extend from
the proximal end of the body to the distal end of the body, and may
further extend distal to the body. In some embodiments, the liner
may be inside the body and extend through the body, and in some
embodiments may further extend through the tip. In some
embodiments, the tip may be essentially the distal end of the
liner. In other embodiments, the tip may further have a tubular end
sleeve, which may be substantially comprised of polymer. The tip
may also have an anti-collapsing structure, which may be a groove,
a coil, or a braid. The device may also have at least one marker.
Some embodiments of the present invention include a fiber extending
through the body, which may be configured to increase the device's
tensile strength. The fiber may be substantially comprised of a
high-strength material, and may zigzag between the body and the
liner.
[0009] A further exemplary embodiment of the present invention
includes a method of treating a patient with a medical device. The
method may include the steps of selecting a medical device, which
may have a flexible tip; shaping the tip, for instance by bending
it; and inserting the device into the anatomy or vasculature. The
step of inserting the device may include axially translating the
device, rotating the device, and monitoring the distal end or tip.
The tip may be made of a nonmetallic material and may have at least
one marker to facilitate monitoring by observing it, for instance,
with X-ray fluoroscopy. The method may also have the step, after
the step of shaping, of setting the shape of the tip, for example,
by heating the tip. The device may be substantially tubular, and
the method may also include the step, after the step of shaping, of
removing a mandrel from the tip that had been previously inserted.
After the device is inserted into the anatomy or vasculature, the
method may include the step of performing a medical procedure using
the device, for example, treating an aneurysm. The method may
further include the step of removing the device, which may involve
using a fiber running substantially through the device. The fiber
may accordingly be configured to assure complete removal of the
device.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The figures in this document illustrate various exemplary
embodiments of the present invention. Embodiments of the present
invention may include part or all of the features shown in one of
these drawings, or may include features from two or more figures.
Embodiments of the present invention may also include features
described in the specification, or limitations to features
described in the specification. Furthermore, embodiments of the
present invention may include features that would be familiar to a
person of ordinary skill in the art having studied this
document.
[0011] FIG. 1 is a side view illustrating an embodiment of a
medical device in accordance with the present invention;
[0012] FIG. 2 is a detail isometric view illustrating a portion of
the body and liner of the medical device illustrated in FIG. 1;
[0013] FIG. 3 is a detail isometric view illustrating another
portion of the body and liner of the medical device illustrated in
FIG. 1;
[0014] FIG. 4 is an isometric view showing an exemplary embodiment
of the tip of a medical device in accordance with the present
invention;
[0015] FIG. 5 is a sectional side view further illustrating the
exemplary embodiment of the tip of the medical device shown in FIG.
4, illustrating the tip substantially comprising the liner;
[0016] FIG. 6 is an isometric view showing another exemplary
embodiment of the tip of a medical device in accordance with the
present invention;
[0017] FIG. 7 is a sectional side view further illustrating the
exemplary embodiment of the tip of the medical device shown in FIG.
6, illustrating, among other things, an end sleeve;
[0018] FIG. 8 is an isometric view showing additional features that
may be part of the tip of the medical device shown in FIG. 6,
including a fiber;
[0019] FIG. 9 is a sectional side view further illustrating the
additional features shown in FIG. 8;
[0020] FIG. 10 is an isometric view showing an exemplary embodiment
of an anti-collapsing structure and markers that may be part of the
tip of a medical device in accordance with the present
invention;
[0021] FIG. 11 is an isometric view showing another exemplary
embodiment of an anti-collapsing structure and markers that may be
part of the tip of a medical device in accordance with the present
invention;
[0022] FIG. 12 is a sectional side view further illustrating the
anti-collapsing structure and markers shown in FIG. 11;
[0023] FIG. 13 is an isometric view showing another exemplary
embodiment of an anti-collapsing structure and markers that may be
part of the tip of a medical device in accordance with the present
invention;
[0024] FIG. 14 is a side view illustrating an embodiment of markers
in accordance with the present invention;
[0025] FIG. 15 is a side view illustrating another embodiment of
markers in accordance with the present invention;
[0026] FIG. 16 is a detail sectional side view showing the
embodiment of markers illustrated in FIG. 14;
[0027] FIG. 17 is a detail sectional side view showing the
embodiment of markers illustrated in FIG. 15;
[0028] FIG. 18 is a side view illustrating setting the tip of an
exemplary embodiment of the present invention;
[0029] FIG. 19 is a cut-a-way side view illustrating using the bend
in the tip of a medical device in accordance with an exemplary
embodiment of the present invention to facilitate navigation
through a bifurcation in vasculature;
[0030] FIG. 20 is a cut-a-way side view illustrating using the bend
in the tip of a medical device in accordance with an exemplary
embodiment of the present invention to treat an aneurysm; and
[0031] FIG. 21 is a flow chart illustrating steps of an exemplary
embodiment of a method in accordance with the present
invention.
DETAILED DESCRIPTION
[0032] The present invention provides medical devices and
intravascular devices such as hollow guide wires, and methods of
using medical devices and intravascular devices. Exemplary
embodiments of medical devices in accordance with the present
invention may be flexible in bending, minimize trauma to the
patient's anatomy or vasculature, assure complete removal of the
medical device, or provide a combination of these features. Other
features may also be provided.
[0033] Accordingly, FIG. 1 illustrates an embodiment of a medical
device 100 in accordance with the present invention that includes a
body 105 that has a proximal end 107, a distal end 109, and an axis
(longitudinal axis) extending through the proximal end 107 and the
distal end 109. Medical device 100 may be, for example, an
endovascular or intravascular device. The body 105 may have a
plurality of cuts 110 (one of which is labeled 110 on FIG. 1) part
way through the body 105, and the cuts 110 may be approximately or
substantially perpendicular to the axis. The body 105 may have a
portion 112 without any cuts 110, a portion 113 with cuts 110
relatively far apart, and a portion 114 with cuts 110 relatively
close together. Exemplary embodiments of portions 113, and 114, and
cuts 110 are illustrated in more detail in FIGS. 2 and 3. Cuts 110
may be saw cut, notched, laser cut, ground, EDMed, etched, forged,
molded, or formed by another method suitable for shaping the
material from which body 105 is made. The geometry of cuts 110 may
be as shown, or in various embodiments may be of other geometries
forming openings through the wall of body 105. Returning to FIG. 1,
the spacing of cuts 110 may vary gradually from portion 113 to
portion 114, or the spacing may vary discreetly. In some
embodiments, the spacing of cuts 110 may be substantially uniform
throughout all or part of body 105. In some embodiments, the
geometry of cuts 110 may vary, for example, in width (in the
direction of the axis of body 105) or depth.
[0034] Still referring to FIG. 1, medical device 100 may further
include a tip 120 on the distal end of medical device 100, which
may extend from the distal end 109 of body 105. As will be
described in further detail below, tip 120 may substantially
comprise one or more non-metallic materials, for example, a polymer
material. Due in some embodiments to the properties of the material
from which it is made, its dimensions, or both, tip 120 may be more
flexible in bending than body 105. In other words, tip 120 may be a
flexible tip. In addition, as will be described in more detail
below, tip 120 may be configured to be custom shaped by the person
who will operate the device 100, for example, to perform a medical
procedure. Tip 120 may have its own distal end 111, for example on
the far distal end of device 100. Tip 120 may be marked, for
example, on the distal end 111 of tip 120, for example, with a
marker band, or other indication. The presence of this marking or
indication may be checked upon removal of device 100 from the
patient to verify that all of device 100 has been completely
removed. Tip 120 may be flared at distal end 111, for example, on
the inside, or may be rounded, for example to minimize trauma to
the anatomy or vasculature.
[0035] Referring to FIGS. 2 and 3, body 105 may be substantially
comprised of metal, which may be a nickel-titanium alloy (nitinol).
The nitinol may be a super-elastic nitinol, meaning its transition
temperature may be below the use temperature. In many embodiments
of the present invention, the use temperature may be human body
temperature or room temperature. In other embodiments, body 105 may
be a polymer material or stainless steel, or another material
suitable for the application. Body 105 may be substantially tubular
as shown, or in some embodiments, may be solid. Medical device 100
may further comprise a substantially tubular liner 203, which may
extend the length of body 105, for example from proximal end 107 at
least to distal end 109. Liner 203 may be located inside body 105
(as shown) or may be located outside body 105. Liner 203 may be
located inside body 105, for example, to make the inside of device
100 smoother to reduce friction or abrasiveness, for example, for
passing objects through the interior of device 100. Liner 203 may
be located outside body 105, for example, to make the outside of
device 100 smoother to reduce friction, abrasiveness, and trauma to
the anatomy or vasculature. Some embodiments of the present
invention may have two liners 203, one inside body 105 and one
outside body 105.
[0036] Liner 203 may lack many or all of the cuts 110 of body 105,
thus forming a barrier that may reduce or eliminate leakage between
the interior and exterior of body 105. In other words, liner 203
may seal cuts 110. Liner 203 may be made of an elastomeric
material. Liner 203 may be made of a polymer, such as a
polyethylene blend, or PTFE. Liner 203 may further extend distal to
body 105 (for example beyond distal end 109), for example, through
tip 120, and, as illustrated best in FIG. 5, in some embodiments,
may substantially comprise or form tip 120 As used herein, tip 120
substantially comprises liner 203 in embodiments where tip 120 is
comprised of part of liner 203, but tip 120 does not include a
separate end sleeve 726 (illustrated in FIG. 7). As used herein,
the statement that tip 120 substantially comprises liner 203 does
not mean that tip 120 does not have markers 122 and 123, or an
anti-collapsing structure (e.g. coil 1032 or braid 1333) (described
below).
[0037] End sleeve 726 may be substantially tubular and is
illustrated in FIGS. 6-13, and is a component of some embodiments
of medical device 100. End sleeve 726 may have the same or a
similar inside and outside diameter as distal end 109 of body 105
(illustrated best in FIG. 7), and may substantially comprise a
polymer material. End Sleeve 726 may, for example, be a lamination
of PEBAX, for instance, and may have a durometer hardness of 85A.
Various hardnesses may be preferred for various applications and
embodiments. End sleeve 726 may, in some embodiments, be attached
to body 105, for example, with an adhesive. In some embodiments of
tip 120, liner 203 and end sleeve 726 may be attached to each
other, for example with an adhesive (e.g. cyanoacrylate), or may
not be attached to each other, e.g. to promote flexibility of tip
120. Embodiments having two liners 203 (for example, a first liner
203 inside the body and a second liner 203 outside the body) may
have an end sleeve 726 disposed between the two liners 203. In
embodiments with either one or more liners, the end sleeve 726 may
extend beyond (distal to) the end or ends of one or more liners
203. In other words, one or more liners 203 may terminate
substantially proximal to the distal end 711 of end sleeve 726. As
used here, substantially proximal means at least 10 percent of the
length of tip 120 from the distal end 711 of end sleeve 726.
[0038] As illustrated in FIGS. 10-13, tip 120 of medical device 100
may further comprise an anti-collapsing structure, which may be
coil 1032 as illustrated in FIGS. 10-12 or braid 1333 as
illustrated in FIG. 13. The anti-collapsing structure (e.g. coil
1032 or braid 1333) may be located between liner 203 and end sleeve
726 as illustrated best in FIG. 12. In some embodiments, the
anti-collapsing structure may be one or more grooves 1035 as
illustrated in FIG. 12. Groove 1035 may be a helical groove
(shown), or may be a plurality of circular grooves, for example
circumferential to the axis of body 105 or medical device 100.
Groove 1035 may be cut in part of tip 120, for example, liner 203
or end sleeve 726 (shown). Groove 1035 may be cut on the inside
(shown) or the outside, depending on the embodiment. As would be
apparent to a person skilled in the art, the outside may be more
accessible for cutting groove 1035, particularly in smaller
diameter embodiments of device 100. Coil 1032 may be located inside
groove 1035 (for example, where groove 1035 is helical). In other
embodiments, groove 1035 may be hollow or may contain another
component or material. For example, in embodiments having a
plurality of circumferential grooves 1035, rings may be disposed in
grooves 1035, e.g. rings comprised of a metal or polymer, which may
have a substantially higher stiffness (e.g., modulus of elasticity)
than liner 203 or end sleeve 726.
[0039] Medical device 100 may comprise at least one tip marker 122
or 123 as illustrated in FIGS. 1 and 4-20. As illustrated, many
embodiments include two markers, marker 122 at the distal end 111
of tip 120 and marker 123 at the base of tip 120, for example, near
distal end 109 of body 105. As used herein, the statement that tip
120 substantially comprises a non-metallic material means, for
example, that liner 203 and exterior portion 726 (in embodiments
where provided) are not made of metal, but markers 122 and 123, and
anti-collapsing structure (e g coil 1032 or braid 1333) may be any
material including a metal. Markers 122 and 123 may be made of a
material such as platinum that is readily distinguishable with
X-ray fluoroscopy. Markers 122 and 123 may be short tubular sleeves
or bands as illustrated in FIGS. 4-10, 13, 14, and 16, or may be
coils as illustrated in FIGS. 11, 12, 15, and 17. In some
embodiments having an anti-collapsing structure that is a coil
1032, markers 122, 123, or both, may be formed from the same wire
as coil 1032, and may be integral therewith. For illustration, see
FIG. 11. In other embodiments, markers 122 and 123 may be coils but
may be separate components from coil 1032. The coils of markers 122
and 123 may be closer together (i.e. in the axial direction) than
the coils of coil 1032 as shown. The coils of markers 122 and 123
may, in fact, be touching each other or nearly touching. The
markers 122 and 123 may be located between liner 203 and end sleeve
726 as illustrated best in FIGS. 7, 9, and 12. Markers 122 and 123
may be covered all or in part by a material 528 (as illustrated
best in FIG. 5 for marker 123) that may be smooth, soft, slippery,
or some combination thereof to minimize trauma to the patient's
anatomy or vasculature 1990. Material 528 may be an adhesive, for
example, a UV adhesive. In some embodiments, for example, not
having an end sleeve 726, markers 122 and 123 may be located inside
liner 203 (as illustrated in FIG. 5 for marker 122).
[0040] There may be an interference fit between marker 122 or 123
and liner 203. And, there may be an interference fit between marker
122 or 123 and end sleeve 726. Such interference fits may hold
markers 122 and 123 in place. Markers 122 and 123 may also be held
in place with an adhesive, or may be thermally fused, i.e. by
melting a polymer such as a thermal plastic around marker 122 or
123. Material 528 shown in FIG. 5, for example, may be an adhesive
or a polymer. In some embodiments, markers 122, 123, or both may be
recessed in a groove 1651 as illustrated in FIGS. 14-17. Groove
1651 may be cut, for example, in body 105 as shown, but may
alternatively be cut in liner 203 or end sleeve 726, for further
example. Markers 122 and 123 may be short cylinders or sleeves as
illustrated in FIGS. 14 and 16, which may be crimped or swaged into
groove 1651 In another embodiment, illustrated in FIGS. 15 and 17,
markers 122 and 123 may be coils, which may be expanded to install
them in groove 1651. Markers 122 and 123 may be covered with a
material 528 as described above and as illustrated in FIGS. 15 and
17 to help hold markers 122 and 123 in place or to minimize trauma
to the patient's anatomy or vasculature 1990.
[0041] As illustrated in FIGS. 8-13, medical device 100 may have a
fiber 840 extending through body 105. Fiber 840 may be configured
to provide tensile strength (for example, redundant tensile
strength) to medical device 100 or increase its tensile strength,
for example, to assure complete removal of device 100 from the
patient. As used herein, being configured to increase the tensile
strength of device 100 includes increasing device 100's ultimate
tensile strength, and providing redundancy in the tensile strength
of device 100, for example, in case body 105, liner 203, or another
component or joint has less tensile strength than anticipated.
Thus, in some embodiments, fiber 840 may have a greater tensile
strength than the remainder of medical device 100, but in other
embodiments fiber 840 may have a lower tensile strength than a
properly manufactured and undamaged device 100. Fiber 840 may
substantially comprise a material selected for its high tensile
strength. Fiber 840 may be a polymer, a metal, a carbon fiber, a
ceramic fiber, or a combination of fibers. Fiber 840 may be formed
from a composite material, and the fibers of the composite material
may be substantially aligned in the axial direction of fiber 840.
Fiber 840 may, for example, be made of KEVLAR.
[0042] Fiber 840 may be located between body 105 and liner 203, and
may bend back and forth or zigzag, for example in a somewhat
sinusoidal pattern, be bunched, or wound in a spiral, so as to
avoid or minimize increasing the bending stiffness of medical
device 100 or maintain symmetrical bending properties of medical
device 100 around its longitudinal axis. For example, fiber may
zigzag back and forth over approximately 1/2 of the diameter of
device 100. This zigzag pattern may, for instance, continue along
one side of device 100, or may gradually spiral around device 100.
Fiber 840 may wind (for example winds 842) around at least part of
the components of tip 120, for instance, to help secure tip 120 to
fiber 840. For example, fiber 840 may wind (winds 842) around liner
203 (shown) or end sleeve 726. Fiber 840 may be secured, for
instance, to tip 120, for example, by being glued, twisted, or
tied. Some embodiments may have a plurality of fibers 840. For
example, in one embodiment device 100 may have two fibers 840 that
may zigzag, for example, on opposite sides, or may spiral in
opposite directions.
[0043] Various dimensions of tip 120 may be desirable for various
embodiments of the present invention. Specifically, in various
embodiments, tip 120 may be from as little as 1 millimeter in
length to as long as 1500 millimeters in length. Other embodiments
may even be outside of this range. Shorter lengths (e.g. as short
as 1 millimeter long) may, for example, provide a soft tip 120 for
medical device 100, which may reduce trauma to the patient's
anatomy, for example, compared with having no tip 120 at all.
Longer tips 120 may offer the other advantages described herein.
Some embodiments of the present invention may have a tip 120 that
is 10 to 40 millimeters long. For instance, embodiments of the
present invention may have a tip 120 that is 31 millimeters long,
and markers 122 and 123 may be 30 millimeters apart on embodiments
having such markers. Such lengths may offer the various features
and advantages described herein.
[0044] In addition, various outside diameters of medical device 100
may be desirable for various embodiments of the present invention.
Generally, body 105 may have an outside diameter in the range of
0.010 to 0.500 inches. Other embodiments may even be outside of
this range. For instance, some embodiments may be larger in
diameter. However, within the range identified, some embodiments of
the present invention may have a body with an outside diameter in
the range of 0.030 to 0.040 inches. For example, embodiments of the
present invention may have a body 105 with an outside diameter of
0.033 inches. Other embodiments may have a body with an outside
diameter in the range of 0.020 to 0.040 inches. Still other
embodiments may have a body with an outside diameter in the range
of 0.015 to 0.040 inches. In some embodiments, the diameter of body
105 may vary along its length, for example, with the largest
diameter at the proximal end 107 and the smallest diameter at the
distal end 109. The outside diameter of tip 120 may be similar or
less than the outside diameter of body 105, for instance, 0.033
inches.
[0045] Furthermore, various lengths of medical device 100 may be
desirable for various embodiments of the present invention. Medical
device 100 may be, for example, 155 centimeters long. Referring to
FIG. 1, portions 112 and 113 with cuts 110, and tip 120, may total,
for example, 48 centimeters long.
[0046] Turning now to methods of using, for example, medical device
100, FIG. 18 illustrates how tip 120 of medical device 100 may be
set in shape with steam 1848 and mandrel 1840 prior to using
medical device 100. FIG. 19 illustrates how the shape or curvature
of tip 120 may be used to navigate medical device 100 through a
bifurcation 1995 in the patient's anatomy or vasculature 1990. FIG.
20 further illustrates how the shape or curvature of tip 120 may be
used to treat an aneurysm 2092 in the patient's vasculature 1990.
Even further, FIG. 21 illustrates various steps of an exemplary
embodiment of a method in accordance with the present invention,
method 2100.
[0047] Method 2100 illustrates a method of treating a patient with
a medical device (e.g. device 100). First, the physician, for
example, may examine the patient (step 2161) to determine what the
problem is (e.g. an aneurysm) and plan the procedure (step 2163),
for example, to correct the problem. Method 2100 then generally
includes the step of selecting a medical device (step 2166), which
may have various attributes of medical device 100, described above
such as having a tip 120 or cuts 110. Selecting medical device 100
may include, for example, choosing the desired diameter and length
of device 100. Various other features may be selected, including
those features and embodiments described herein. Method 2100 also
includes shaping (step 2171) tip 120, which may comprise bending
tip 120; and inserting (step 2178) medical device 100 into anatomy
or vasculature 1990. Then the physician or operator may guide (step
2181) the device 100 through the anatomy or vasculature (e.g.
1990). Inserting (step 2178) or guiding (step 2181) may comprise
axially translating medical device 100, rotating medical device
100, and monitoring the distal end 109 or tip 120 (e.g. distal end
111) of medical device 100. For example, as illustrated in FIG. 19,
when medical device 100 approaches a bifurcation 1995, for
instance, in vasculature 1990, the operator may rotate the proximal
end 107 (shown in FIG. 1) of device 100 while monitoring or
observing marker 122 on distal end 111 of tip 120, and possibly
also marker 123, for example, with an X-ray viewer. When marker
122, and thus distal end of device 100 and tip 120 (distal end
111), is pointed toward the desired passageway of vasculature 1990,
the operator may then push medical device 100 further into
vasculature 1990 so that tip 120 goes into the desired
passageway.
[0048] Method 2100 may further comprise the step, after shaping tip
120 (step 2171), of setting (step 2173) the shape of tip 120.
Setting (step 2173) the shape may comprise heating tip 120, as
illustrated in FIG. 18. Medical device 100 may be substantially
tubular, and method 2100 may further comprise the step, after
shaping tip 120 (step 2171), of removing (step 2176) a mandrel 1840
from tip 120. Thus, tip 120 may be shaped (step 2171) by bending
tip 120 while a mandrel 1840 is inside tip 120. The mandrel 1840,
which may be wire, for example, stainless steel, will then hold the
shape of tip 120 while tip 120 is heated, for instance, with steam
1848 produced by steam source 1845. Thus, the operator or physician
who is about to perform the medical procedure (step 2183) with
medical device 100, may bend (step 2171) tip 120 based on the shape
needed for the particular procedure and the patient's particular
anatomy. The physician may then set the shape (step 2173) by
heating tip 120 with a steam source 1845 that may be readily
available. Then the physician may remove mandrel 1840 (step 2176),
leaving tip 120 with the desired shape, but flexible. Mandrel 1840
may have been inserted (step 2168) by the physician, or may have
been inserted by the manufacturer of device 100 before shipment to
the physician.
[0049] Method 2100 may further comprise the step, after inserting
medical device 100 into the anatomy or vasculature 1990 (step
2178), of performing a medical procedure step 2183) using medical
device 100. The medical procedure (of step 2183) may be, for
example, treatment of aneurisms, AVMs, bleeds, tumors, embolisms,
embolic stroke thrombolysis, and thrombolectomy. In an exemplary
embodiment, the procedure (of step 2183) may include treating an
aneurysm 2092 as illustrated in FIG. 20, for example, a cerebral or
brain aneurysm Such a treatment may involve, for example,
introduction of an agent such as a glue material through device
100, stenting, installation of a graft, or balloon immobilization.
Other procedures (of step 2183) may include obtaining access to the
uterus, fallopian tubes, urinary tract, sinuses, esophagus, lungs,
vertebroplasty, and gastroenterology. A gradual curvature of tip
120 is shown in FIG. 20; however, tip 120 may be shaped in radial
bends, for example from 5 degrees to 120 degrees or in other
complex shapes as needed by the physician. The length of tip 120
extending distal to the bend may be selected based on the size of
the aneurysm 2092, the size of the vasculature 1990, and other
factors
[0050] Method 2100, may further comprise the step of removing
medical device 100 (step 2186). This may involve using fiber 840
described above, for example, running substantially through medical
device 100. To remove medial device 100, the operator or physician
may pull on the proximal end 107 of medical device 100. If medical
device 100 should pull apart or break, for example, tip 120 should
separate from body 105, then fiber 840 may be utilized to
facilitate or assure complete removal of medical device 100,
including tip 120. To do so, the operator or physician may continue
pulling on proximal end 107. After the slack is taken up from fiber
840, fiber 840 will then pull on tip 120. Accordingly, Fiber 840
may be configured to facilitate or assure complete removal of
medical device 100. The physician may also provide post-procedure
care (step 2188) to the patient, for example, verifying that the
problem is corrected and that no complications have developed.
[0051] The above embodiments are illustrative of the present
invention, but are not intended to limit its scope. Numerous
modifications and alternative arrangements may be devised by those
skilled in the art without departing from the spirit and scope of
the present invention, and the appended claims are intended to
cover such modifications and arrangements.
* * * * *