U.S. patent application number 14/204382 was filed with the patent office on 2014-09-18 for vibrating catheter and methods of use.
This patent application is currently assigned to VOLCANO CORPORATION. The applicant listed for this patent is VOLCANO CORPORATION. Invention is credited to David G. Miller.
Application Number | 20140276923 14/204382 |
Document ID | / |
Family ID | 51530994 |
Filed Date | 2014-09-18 |
United States Patent
Application |
20140276923 |
Kind Code |
A1 |
Miller; David G. |
September 18, 2014 |
VIBRATING CATHETER AND METHODS OF USE
Abstract
The invention provides a method of intravascular intervention
that includes inserting a catheter comprising an extended body into
a lumen within tissue of a patient, advancing the catheter to a
treatment site, vibrating a proximal end of the catheter with a
mechanical vibrator, and treating the treatment site while a distal
end of the catheter is vibrating.
Inventors: |
Miller; David G.; (North
Andover, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VOLCANO CORPORATION |
San Diego |
CA |
US |
|
|
Assignee: |
VOLCANO CORPORATION
San Diego
CA
|
Family ID: |
51530994 |
Appl. No.: |
14/204382 |
Filed: |
March 11, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61777394 |
Mar 12, 2013 |
|
|
|
61777407 |
Mar 12, 2013 |
|
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Current U.S.
Class: |
606/128 |
Current CPC
Class: |
A61B 17/3207 20130101;
A61M 25/0102 20130101; A61M 25/104 20130101; A61B 17/22012
20130101; A61B 17/2202 20130101 |
Class at
Publication: |
606/128 |
International
Class: |
A61B 17/22 20060101
A61B017/22; A61B 17/3207 20060101 A61B017/3207 |
Claims
1. A method of intravascular intervention, the method comprising:
inserting a catheter comprising an extended body into a lumen
within tissue of a patient; advancing the catheter to a treatment
site; vibrating a proximal end of the catheter with a mechanical
vibrator; and treating the treatment site while a distal end of the
catheter is vibrating.
2. The method of claim 1, wherein the mechanical vibrator comprises
a linear motor.
3. The method of claim 2, wherein linear motor comprises a mass
coupled to the motor by a spring.
4. The method of claim 2, wherein the linear motor comprises a pair
of eccentric rotatable weights.
5. The method of claim 1, wherein the mechanical vibrator comprises
a piezoelectric vibrator.
6. The method of claim 1, wherein the mechanical vibrator comprises
an ultrasonic actuator.
7. The method of claim 1, wherein the mechanical vibrator comprises
a non-resonant linear motor driving a mass.
8. The method of claim 1, wherein a distal portion of the guidewire
comprises a low-friction surface treatment.
9. The method of claim 1, further comprising advancing a guidewire
to a chronic total occlusion and advancing the catheter over the
guidewire.
10. The method of claim 9, wherein the catheter comprises a
balloon.
11. A device for intravascular intervention, the device comprising:
a catheter member comprising an extended body with a proximal end
and a distal end; a housing area at the proximal end; and a
mechanical vibrator coupled to the housing area.
12. The device of claim 11, wherein the mechanical vibrator
comprises a linear motor.
13. The device of claim 12, wherein linear motor comprises a mass
coupled to the motor by a spring.
14. The device of claim 12, wherein the linear motor comprises a
pair of eccentric rotatable weights.
15. The device of claim 11, wherein the mechanical vibrator
comprises a piezoelectric vibrator.
16. The device of claim 11, wherein the mechanical vibrator
comprises an ultrasonic actuator.
17. The device of claim 11, wherein the mechanical vibrator
comprises a non-resonant linear motor driving a mass.
18. The device of claim 11, wherein a distal portion of the
catheter comprises a low-friction surface treatment.
19. The device of claim 11, further comprising a guidewire within
the catheter.
20. The device of claim 19, wherein the catheter comprises a
treatment comprising a balloon or a stent.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of, and priority to,
U.S. Provisional Patent Application No. 61/777,394, filed Mar. 12,
2013, and also to U.S. Provisional Patent Application No.
61/777,407, filed Mar. 12, 2013, the contents of each of which are
incorporated by reference.
FIELD OF THE INVENTION
[0002] The invention generally relates to systems and methods for
intravascular intervention.
BACKGROUND
[0003] People die from heart attacks. Heart attacks can be caused
by the slow buildup of atherosclerotic plaque inside the blood
vessels. The buildup of plaque occludes the flow of blood, and thus
nutrients and oxygen, to a person's tissue and brain. Sometimes
chunks of the atherosclerotic plaque break away and flow through
the person's blood vessels. This can lead to serious and deadly
strokes and heart attacks. If the plaque buildup is extensive
enough, it will fully occlude the flow of blood, forming what is
called a chronic total occlusion or CTO. If a CTO is not opened up,
it can be fatal.
[0004] One approach to treating a CTO is to insert an intravascular
guidewire and use it to push across the CTO followed by a catheter.
Unfortunately, guidewires and catheters are subject to a lot of
friction. For example, where the guidewire extends through the
patient's convoluted blood vessels within a catheter, at each bend,
the catheter is curved, and the guidewire will typically be pushed
against the wall of the catheter (i.e., the inside wall at the apex
of the curve and the outside wall at the ends of the curve). The
friction causes numerous problems. First, it is difficult to slide
the guidewire to and through the CTO in a smooth deft motion
because the friction interferes. Second, since the guidewire will
not move until the friction is overcome, sometimes the guidewire
resists motion and then moves forward suddenly. Unfortunately,
crossing the CTO requires a lot of force but also precise control
over that force.
SUMMARY
[0005] The invention provides a catheter with a vibrating mechanism
attached that gives a physician great control over an intravascular
procedure by keeping the catheter in motion at times when the
vibrating mechanism is active with the result that the physician
need not overcome a coefficient of static friction. The physician
is at all times faced with a substantially uniform coefficient of
dynamic friction. This amount of friction quickly becomes familiar
to the physician and in fact aids the physician in gently
controlling the motion of the catheter in a smooth fashion. Since
static friction is removed, the catheter or guidewire does not jump
forward in fits and starts with a jerky and uncontrolled motion.
Additionally, the motion of the catheter draws fluid along the
surface of the guidewire (e.g., blood or exogenous contrast),
lubricating the surface. Fluid is drawn into the catheter, where
applicable. Where the guidewire lies against a vessel wall or the
plaque of a CTO, fluid is drawn into that interface, lubricating
it. The lubricated, vibrating guidewire thus is able to push
through the CTO in a smooth, controlled motion. This gives a
physician tools for crossing a CTO, opening up a patient's blood
vessels. Also, by crossing the CTO with a guidewire, a physician
can then use the guidewire to take the catheter across the CTO. The
catheter can be used to deliver treatments, such as angioplasty
balloons or stents. In this way, a catheter of the invention can be
used to resolve life-threatening plaque buildup and avoid heart
attacks.
[0006] In certain aspects, the invention provides a method of
intravascular intervention that includes inserting a catheter
comprising an extended body into a lumen within tissue of a
patient, advancing the catheter to a treatment site, vibrating a
proximal end of the catheter with a mechanical vibrator, and
treating the treatment site while a distal end of the catheter is
vibrating. The mechanical vibrator may include a linear motor, a
mass coupled to the motor by a spring, a pair of eccentric
rotatable weights, a piezoelectric vibrator, an ultrasonic
actuator, a non-resonant linear motor driving a mass, or a
combination thereof. A distal portion of the catheter may
optionally be given a low-friction surface treatment (e.g., such as
a coating of PTFE on an exterior or interior surface of the
catheter). In some embodiments, the method includes advancing the
catheter over a guidewire to a chronic total occlusion. The
catheter can be used to deliver a treatment such as a stent or
balloon.
[0007] In related aspects, the invention provides a device for
intravascular intervention that includes a catheter member
comprising an extended body with a proximal end and a distal end, a
torquer fixed to the proximal end, and a mechanical vibrator
coupled to the torque. The torque may include a pin vise. The
device may include a guidewire within the catheter. The catheter
can be used to deliver a treatment (e.g., with a balloon or a
stent).
BRIEF DESCRIPTION OF THE DRAWINGS
[0008] FIG. 1 shows a guidewire with catheter according to certain
embodiments.
[0009] FIG. 2 shows a reinforcement coil.
[0010] FIG. 3 depicts a linear motor.
[0011] FIG. 4 illustrates a catheter with a mechanical
vibrator.
[0012] FIG. 5 illustrates a catheter with mechanical vibrator with
a spring.
[0013] FIG. 6 shows use of a catheter and guidewire to approach an
occlusion.
[0014] FIG. 7 shows crossing an occlusion with a vibrating
catheter.
DETAILED DESCRIPTION
[0015] The invention generally relates to catheters that vibrate.
Systems and methods of the invention operate to decrease ambient
friction around a guidewire and catheter via a vibration motion of
the catheter. Additionally, the motion of the guidewire or catheter
can aid in crossing a CTO.
[0016] FIG. 1 shows an system 101 including a catheter 111 and a
guidewire 109 according to certain embodiments of the invention.
Catheter 111 includes a proximal portion 103 that is generally
outside of a patient during use and a distal portion 105 configured
for insertion into a patient. Guidewire 109 also includes a
proximal portion and a distal portion 105. Either catheter 111 or
guidewire 109 includes at least one optical fiber for photoacoustic
image as described herein. Proximal portion 103 may generally be
said to define a housing area in that guidewires, endoscopes, or
surgical implements may enter catheter 111 through proximal portion
103 and be housed, at least in part, within proximal portion
103.
[0017] Catheter 111 is capable of being delivered over a guidewire
109. In some embodiments (not pictured in FIG. 1), catheter 111 is
an intravascular balloon catheters as is used for such procedures
as balloon angioplasty, or percutaneous transluminal coronary
angioplasty (PTCA). Catheter 111 generally has an elongate tubular
shaft 111 with proximal portion 103 and distal portion 105, and may
include one or more passages or lumens. Use of pliable materials
provides flexibility or maneuverability, allowing a catheter to be
guided to a treatment site in a patient's blood vessels.
Preferably, a catheter of the invention has enough stiffness to
allow it to be pushed to a target treatment site, and accordingly,
an ability to optimize a balance of pliability versus stiffness or
pushability is beneficial to medical use. In certain embodiments,
catheter 111 includes a stiffening wire or coil, or a reinforcement
coil, to aid in transmitting the vibration form the proximal end to
the distal end. Additionally, a shaft of the catheter can be
provided that is capable of transmitting torque along an axis of
the shaft. Devices for cardiovascular intervention are discussed in
U.S. Pat. Nos. 6,830,559; 6,074,362; and U.S. Pat. No. 5,814,061,
the contents of each of which are incorporated by reference.
[0018] Catheter 111 could optionally include an angioplasty balloon
107 or other interventional device at distal portion 105 to expand
or dilate blockages in blood vessels or to aid in the delivery of
stents or other treatment devices. Blockages include the narrowing
of the blood vessel called stenosis.
[0019] Typically, a catheter 111 will include a guidewire lumen so
that the catheter may be advanced along a guidewire. Guidewire
lumen in a balloon catheter is described in U.S. Pat. No. 6,022,319
to Willard. Catheter 111 may include any suitable material such as,
for example, nylon, low density polyethylene, polyurethane, or
polyethylene terephthalate (PET), or a combination thereof (e.g.,
layers or composites). An inner surface of a guidewire lumen may
include features such as a silicone resin or coating or a separate
inner tube made, for example, of preformed polytetrafluoroethylene
(PTFE). The PTFE tube may be installed within the catheter shaft by
sliding it into place and then shrinking the catheter shaft around
it. This inner PTFE sleeve provides good friction characteristics
to the guidewire lumen, while the balance of the catheter shaft can
provide other desired qualities. Other suitable materials for use
in catheter 101 or an inner tube portion thereof include high
density polyethylene (HDPE) or combinations of material, for
example, bonded in multiple layers.
[0020] Catheter 111 may include coaxial tubes defining separate
inflation and guidewire lumens, for example, along a portion of, or
an entirety of, a length of catheter 111. A plurality of lumens may
be provided in parallel configuration or coaxial at one point and
parallel at another, with a twisting/plunging portion to affect a
transition between the parallel segment and the coaxial segment
(see., e.g., U.S. Pat. No. 7,044,964). Other possible
configurations include one or more of a guidewire tube or guidewire
lumen disposed outside of the balloon. Or the guidewire tube may be
affixed to and extend along the wall of the balloon. In some
embodiments, a proximal end of guidewire 109 is mounted in a
torquer device. Any torquer device may be used. For example, a
handle member may be fixed onto proximal end of guidewire 109 by
welding, adhesives, clamps, or other suitable means. In some
embodiments, the torque device comprises a pin vise.
[0021] FIG. 2 shows a reinforcement coil 114 for transmitting
vibration or torque along catheter 111. Coil 114 is preferably a
material that is more rigid than a remainder of a body of catheter
111. Any suitable material may be used for coil 114 such as, for
example, a plastic or polymer, a metal, or a nickel-titanium alloy
or other allow. Coil 114 is depicted as a helix. Other embodiments,
such as a woven mesh, are within the scope of the invention. In
some embodiments, reinforcement is provided by substantially linear
fibers extending along catheter 111. Preferably, catheter 111 is
coupled to a mechanical vibrator. Any suitable mechanical vibrator
can be used. In some embodiments, catheter 111 is connected to a
linear motor.
[0022] FIG. 3 depicts a linear motor 117. Linear motor 117 is an
electric motor that has an unrolled stator and unrolled rotor 119
that produces a linear force along its length. One suitable mode of
operation is as a Lorentz-type actuator, in which the applied force
is linearly proportional to the current and the magnetic field
(F=qv.times.B). One exemplary motor suitable for use as linear
motor is the linear motor sold under the name Dover MAB-100 Linear
Motor by Danaher Motion (Wood Dale, Ill.).
[0023] Any vibratory motor can be used. For example, vibration can
be induced by eccentric weight discs, piezoelectric material,
linear or rotary motors, non-vibrator motors that operate against a
non-uniform surface, or other means known in the art. Vibratory
mechanical devices that can be modified for use with the invention
are described in U.S. Pat. No. 8,336,643 to Harleman; U.S. Pat. No.
6,520,269 to Geiger; U.S. Pat. No. 5,780,958 to Strugach; and U.S.
Pat. No. 4,819,740 to Warrington, the contents of which are
incorporated by reference.
[0024] FIG. 4 illustrates a catheter 111 with a mechanical vibrator
provided by linear motor 117 connected to pin vise 113. Operation
of motor 117 imparts vibration to catheter 111. The vibration is
transmitted from a proximal portion of catheter 111 to a distal
portion (e.g., the distal tip). This can be aided by coil 114.
[0025] FIG. 5 illustrates a catheter 111 with mechanical vibrator
that includes a linear motor 117 fixed to catheter 111, which
drives a mass 202 connected via a spring 201 (partially disposed
behind catheter 111 within motor 117 in the view shown in FIG. 5).
A resonant spring-mass system is beneficial in that it can
accomplish good inertial vibration at low power.
[0026] In some embodiments, a rotating motor drives a gear pair of
eccentric rotating weights. This produces vibration in at least one
direction.
[0027] In certain embodiments, a non-resonant linear motor drives a
mass to produce vibration.
[0028] In some embodiments, vibration is provided by an ultrasonic
actuator or transducer. This may be beneficial where high frequency
vibration is desired and it provides a minimum displacement of
guidewire 109.
[0029] FIGS. 6-7 show use of guidewire 109 for crossing occlusion
152 (e.g., an atherosclerotic plaque) in a blood vessel treatment
site 151. As distal portion 105 of guidewire 109 approaches
treatment site 151 (such as a region of a blood vessel affected by
atherosclerotic plaque), a physician can optionally view site 151
on a monitor of an associated medical imaging instrument (not
pictured). Using mechanical vibrator 117, a distal portion of
catheter 111 is vibrated, as shown in FIG. 7. This keeps catheter
111 in motion at times when the vibrating mechanism is active with
the result that the physician need not overcome a coefficient of
static friction. The physician is at all times faced with a
substantially uniform coefficient of dynamic friction. This amount
of friction quickly becomes familiar to the physician and in fact
aids the physician in gently controlling the motion of the
guidewire in a smooth fashion. Since static friction is removed,
guidewire 109 does not jump forward in fits and starts with a jerky
and uncontrolled motion. Additionally, the motion of catheter 111
draws fluid along the surface of the guidewire (e.g., blood or
exogenous contrast), lubricating the surface. The lubricated,
vibrating guidewire 109 thus is able to push through the occlusion
152 in a smooth, controlled motion. This gives a physician tools
for crossing occlusion 152. Guidewire 109 can be used to deliver a
catheter carrying treatments, such as angioplasty balloons or
stents. Intravascular procedures are described in U.S. Pat. No.
8,361,097 to Patel; U.S. Pat. No. 8,298,149 to Hastings; and U.S.
Pat. No. 5,713,848 to Dubrul, the contents of each of which are
incorporated by reference.
[0030] Such vascular intervention procedures by catheter are often
performed in specialized clinical environments known as cath labs.
The catheterized intervention procedures described herein may be
performed with associated imaging procedures (e.g., using IVUS and
OCT instruments). Exemplary IVUS methods are discussed in U.S. Pat.
No. 8,289,284; U.S. Pat. No. 7,773,792; U.S. Pub. 2012/0271170;
U.S. Pub. 2012/0265077; U.S. Pub. 2012/0226153; and U.S. Pub.
2012/0220865. OCT systems and methods are described in U.S. Pub.
2011/0152771; U.S. Pub. 2010/0220334; U.S. Pub. 2009/0043191; U.S.
Pub. 2008/0291463; and U.S. Pub. 2008/0180683, the contents of each
of which are hereby incorporated by reference in their
entirety.
[0031] In some embodiments, guidewire 109 is used to deliver,
through the use of catheter 111, an angioplasty balloon. Generally,
a balloon will include a flexible, inelastic material designed to
expand. By this type of expansion, a balloon may impose pressures
of several atmospheres to expand the stenosis or may be used to
deploy a stent. After the balloon has been expanded, it is then
deflated and removed from the patient, allowing improved blood flow
through the vessel. Suitable materials may include polyvinyl
chloride (PVC), nylon, polyethylene terephthalate (PET),
polybutylene terephthalate (PBT) and copolyesters,
polyether-polyester block copolymers, polyamides, polyurethane,
poly(ether-block-amide) and the like. Balloons are described in
U.S. Pat. No. 7,004,963; U.S. Pub. 2012/0071823; U.S. Pat. No.
5,820,594; and U.S. Pub. 2008/0124495, the contents of each of
which are incorporated by reference. Balloon catheters are
described in U.S. Pat. No. 5,779,731 and U.S. Pat. No. 5,411,016,
incorporated by reference.
[0032] In some embodiments, the balloon includes artificial muscle
(electro-active polymer). Electro-active polymers exhibit an
ability to change dimension in response to electric stimulation.
The change may be driven by electric field E or by ions. Exemplary
polymers that respond to electric fields include ferroelectric
polymers (commonly known polyvinylidene fluoride and nylon 11, for
example), dielectric EAPs, electro-restrictive polymers such as the
electro-restrictive graft elastomers and electro-viscoelastic
elastomers, and liquid crystal elastomer composite materials. Ion
responsive polymers include ionic polymer gels, ionomeric
polymer-metal composites, conductive polymers and carbon nanotube
composites. Common polymer materials such as polyethylene,
polystyrene, polypropylene, etc., can be made conductive by
including conductive fillers to the polymer to create
current-carrying paths. Many such polymers are thermoplastic, but
thermosetting materials such as epoxies, may also be employed.
Suitable conductive fillers include metals and carbon, e.g., in the
form of sputter coatings. Electro-active polymers are discussed in
U.S. Pat. No. 7,951,186; U.S. Pat. No. 7,777,399; and U.S. Pub.
2007/0247033, the contents of each of which are incorporated by
reference.
[0033] In some embodiments, guidewire 109 is used to deliver,
through the use of catheter 111, a stent. Any suitable stent may be
used with device 101. One exemplary device for stent is the
Palmaz-Schatz stent, described, for example, in U.S. Pat. No.
4,733,665. Suitable stents are described in U.S. Pat. No.
7,491,226; U.S. Pat. No. 5,405,377; U.S. Pat. No. 5,397,355; and
U.S. Pub. 2012/0136427, the contents of each of which are expressly
incorporated herein by reference. Generally, a stent has a tubular
body including a number of intersecting elongate struts. The struts
may intersect one another along the tubular body. In a non-deployed
state, the tubular body has a first diameter that allows for
delivery of the stent into a lumen of a body passageway. When
deployed, the stent has a second diameter and deployment of the
stent causes it to exert a radially expansive force on the lumen
wall. Methods of using stents are discussed in U.S. Pat. No.
6,074,362; U.S. Pat. No. 5,158,548; and U.S. Pat. No. 5,257,974,
the contents of each of which are incorporated by reference. In
some embodiments, stent 161 includes a shape-retaining or shape
memory material such as nitinol and is self-expanding and thermally
activatable within a vessel upon release. Such devices may
automatically expand to a second, expanded diameter upon being
released from a restraint. See, e.g., U.S. Pat. No. 5,224,953, the
contents of which are incorporated herein by reference.
INCORPORATION BY REFERENCE
[0034] References and citations to other documents, such as
patents, patent applications, patent publications, journals, books,
papers, web contents, have been made throughout this disclosure.
All such documents are hereby incorporated herein by reference in
their entirety for all purposes.
EQUIVALENTS
[0035] Various modifications of the invention and many further
embodiments thereof, in addition to those shown and described
herein, will become apparent to those skilled in the art from the
full contents of this document, including references to the
scientific and patent literature cited herein. The subject matter
herein contains important information, exemplification and guidance
that can be adapted to the practice of this invention in its
various embodiments and equivalents thereof.
* * * * *