U.S. patent application number 12/803284 was filed with the patent office on 2011-12-29 for multiple function vascular device.
Invention is credited to Robert A. Palme, Gregory L. Townsend.
Application Number | 20110319905 12/803284 |
Document ID | / |
Family ID | 45353246 |
Filed Date | 2011-12-29 |
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United States Patent
Application |
20110319905 |
Kind Code |
A1 |
Palme; Robert A. ; et
al. |
December 29, 2011 |
Multiple function vascular device
Abstract
A multi-purpose vascular device defines a lumen allowing fluid
communication there through and has a coil with a side of the coil
winds having solid physical connections between the coil winds to
prevent the connected coil wind side from expanding following the
application of force by an actuating member which causes the
connected coil winds to have a predetermined configuration in an
unstressed state. The application of longitudinal force causes the
unconnected coil winds to expand, resulting in the vascular device
assuming a different configuration.
Inventors: |
Palme; Robert A.;
(Lindstrom, MN) ; Townsend; Gregory L.; (Motley,
MN) |
Family ID: |
45353246 |
Appl. No.: |
12/803284 |
Filed: |
June 23, 2010 |
Current U.S.
Class: |
606/127 |
Current CPC
Class: |
A61B 17/320758 20130101;
A61B 2017/22079 20130101; A61B 2017/00305 20130101; A61B 2017/00323
20130101; A61B 2090/08021 20160201; A61B 2017/00867 20130101; A61B
17/00234 20130101 |
Class at
Publication: |
606/127 |
International
Class: |
A61B 17/22 20060101
A61B017/22 |
Claims
1. A vascular device, comprising: a. a shaft defining a
longitudinal dimension, a lumen allowing fluid communication
through the shaft extending along the longitudinal dimension, a
proximal section and a distal section; b. the distal section
defining a weak side and a strong side; and c. an actuating member
attached to the distal section, the actuating member capable of
transmitting longitudinal force to the distal section; wherein
applying longitudinal force to the actuating member causes the weak
side of the distal section to increase in size while the strong
side maintains substantially the same size, resulting in the distal
section deflecting.
2. The vascular device of claim 1 wherein the actuating member is
attached to a distal end of the distal section.
3. The vascular device of claim 1 wherein the vascular device in a
non-stressed configuration has a straight configuration and
applying distal force to the actuating member causes the distal
section to deflect.
4. The vascular device of claim 1 wherein the vascular device in a
non-stressed configuration has a straight configuration and
applying proximal force to the actuating member causes the distal
section to deflect.
5. The vascular device of claim 1 wherein at least the distal
section comprises a coil defining a central space.
6. The vascular device of claim 5 wherein the strong side of the
distal section is prevented from assuming a larger size by a ribbon
attached to the coil, preventing the non-expandable side of the
coil from expanding when longitudinal force is applied to the
coil.
7. The vascular device of claim 6 wherein the ribbon is attached to
the coil at a flattened area configured into the coil.
8. A vascular device, comprising: a. a shaft defining a lateral
dimension, a longitudinal dimension, a proximal section, a distal
section having greater flexibility than the proximal section and a
lumen allowing access through the shaft extending along the
longitudinal dimension; b. the shaft at least partly defining a
coil, the coil further defining a distal end; c. an actuating
member attached to the coil, the actuating member capable of
transferring longitudinal force to the coil; and d. a side of the
coil winds being physically connected, defining a connected side,
to maintain the coil winds on the connected side in a constant
configuration preventing differential spacing resulting from the
application of longitudinal force and causing the connected coil
winds to have a predetermined configuration in an unstressed state;
wherein the application of longitudinal force to the actuating
member causes an unconnected side of the coil winds to expand,
resulting in the vascular device assuming a stressed configuration
having a different shape than the vascular device in the unstressed
configuration.
9. The vascular device of claim 8 wherein the device in the
unstressed state has a straight configuration and applying
longitudinal force to the actuating member causes the distal
section to deflect away from the longitudinal dimension.
10. The vascular device of claim 8 wherein the device in the
unstressed state has an angled configuration and applying
longitudinal force to the actuating member causes the distal
section to deflect toward the longitudinal dimension.
11. The vascular device of claim 8 further comprising the side of
the coil having connected coil winds being connected by a ribbon
attached to the coil.
12. The vascular device of claim 10 wherein the ribbon resides in a
recess formed into a section of the surface of the coil.
13. A vascular device, comprising: a. a shaft defining a lateral
dimension, a longitudinal dimension, a proximal section, a distal
section having greater flexibility than the proximal section and a
lumen allowing access through the shaft extending along the
longitudinal dimension; b. the shaft at least partly defining a
coil, the coil further defining a distal end; c. a flexible cutting
shaft extending through the lumen, the cutting shaft defining a
proximal end and a distal end, with a cutting burr attached to the
distal end of the cutting shaft; d. an actuating member attached to
the coil, the actuating member capable of transferring longitudinal
force to the coil; e. a side of the coil winds being physically
connected, defining a connected side, to maintain the coil winds on
the connected side in a constant configuration preventing
differential spacing resulting from the application of longitudinal
force and causing the connected coil winds to have a predetermined
configuration in an unstressed state; wherein the application of
longitudinal force to the actuating member causes an unconnected
side of the coil winds to expand, resulting in the vascular device
assuming a stressed configuration having a different shape than the
vascular device in the unstressed configuration.
14. The vascular device of claim 13 wherein the device in the
unstressed state has a straight configuration and applying
longitudinal force to the actuating member causes the distal
section to deflect away from the longitudinal dimension.
15. The vascular device of claim 13 further comprising the side of
the coil having connected coil winds being connected by a ribbon
attached to the coil.
16. The vascular device of claim 13 wherein the ribbon resides in a
recess formed into a section of the surface of the coil.
17. The vascular device of claim 13 wherein the cutting shaft is
made of superelastic nitinol.
18. The vascular device of claim 13 wherein at least the distal end
is covered by a sheath.
Description
FIELD OF THE INVENTION
[0001] The present invention relates to apparatus and methods for
performing surgical procedures that access hollow conduits of
mammalian anatomy. More particularly, the invention discloses a
multi-function device for navigating tortuous vascular pathways,
reaching and then crossing total occlusions in blood vessels.
BACKGROUND
[0002] Intracorporal medical devices have been developed and used
to navigate and access the tortuous vascular and other hollow
conduits of a mammalian body. Some of these devices include
guidewires, catheters, intravenous guidewires, stylets, intravenous
catheters and related devices like endoscopes and colonoscopes that
have a predetermined degree of flexibility and may have straight or
pre-formed, shaped ends to guide the device through the anatomical
conduit. Of the devices that are employed to reach vascular
blockages, each has certain advantages and disadvantages. Many fall
short of desired performance before reaching a vascular blockage
because of a device prolapse at a vascular bifurcation, an
inability to enter a bifurcation or be directed to the site of
therapy. Others may reach an occlusion but then require a different
device to be introduced before crossing the stenosis. The medical
industry has striven to reach a balance between the flexibility
required to negotiate around tortuous pathways and the rigidity
necessary to stabilize a catheter's advancement. Many products such
as intravenous interventional guidewires provide directability,
flexibility or stiffness but fail to do all or a combination at the
same time. These products typically have pre-formed flexible distal
ends that provide minimal directability but not true directability,
flexibility and stiffness combined, which would be the most useful
advantage. Additionally, most physicians must use a series of
different diameter guidewires to perform one procedure, creating a
procedure that costs additional time, money and risks patient
safety from vascular injury.
[0003] Accessing occlusions having relatively sharp angles and
passage constrictions using conventional guidewires having
pre-formed "J" shapes or angled distal ends requires rotating the
guidewire while simultaneously moving it proximally and distally.
This action can cause damage to the fragile endothelial cell layer
lining blood vessels. Additionally, conventional guidewires can
lose their ability to be rotated when the flexible distal ends
enter vessels of reduced diameter. Rotation of the guidewire
following inserting the distal end into a vessel having a reduced
diameter produces high frictional forces between the walls of the
small vessels and the guidewire. A desirable device would therefore
require reduced rotation and increased ability to advance in a
forward or distal direction through tortuous anatomies.
[0004] Another undesirable characteristic of conventional
guidewires is the inability to support a catheter at the flexible,
tapered, distal end. When a catheter is advanced toward a vascular
location in and close to a bifurcation, the catheter tends to
proceed in a straight line rather than following the guidewire,
defined as prolapse. Further, the natural pulsation of the vascular
system of a living animal can cause a conventional guidewire to
move into or out of the body during the procedure, thereby losing
its distal location.
[0005] An additional disadvantage of a general use catheter is that
it must be inserted into the body over a guidewire. Therefore, both
a catheter and a guidewire must be used to reach a targeted site
within the body. A single device that functions as an independent
guidewire or both a catheter and a guidewire would save procedural
time, reduce patient recovery time and cause less vascular damage
to the patient.
[0006] Still another disadvantage related to current practices
resides in the catheter itself. Conventional catheters typically
have totally open distal ends. Manufacturers have made efforts to
design catheters with soft distal ends to minimize the extent of
vascular damage when the open end engages the interior wall of
blood vessels. This scraping of the endothelial layer results in a
triggering of the auto immune system, causing clots to form at the
damage site. Also, the distal end of the catheter may become
clogged with material removed from the interior wall of the blood
vessels. It is apparent that this bolus of material will be
expelled from the distal catheter end when another device is
inserted through the catheter. An all-in-one device having a soft,
closed distal end that opens to allow other devices to be deployed
from the distal end and then re-closing when the devices are
withdrawn, would resolve this problem.
[0007] Once the occlusion is reached, the objective is to cross the
blockage with the guidewire or remove the guidewire and insert yet
another device to cut through the occlusion. This is inherently
disadvantageous in that additional time is required and a greater
risk of vascular damage or perforation of the vessel wall is
presented. Conventional devices used to cross the blockage are
generally stiffer than conventional guidewires and when inside the
catheter and reaching a bifurcation can cause the more flexible
catheter to move away from the target site and follow the guide
into the opposite branch of the bifurcation.
[0008] Physicians generally have four objectives when using such
vascular devices: (1) To reach the occlusion; (2) To reach the
occlusion without causing vascular damage; (3) To cross the
occlusion once it is reached; and (4) To reach the occlusion and
cross it in as little time as possible. A device able to accomplish
all four objectives would be extremely advantageous. It is not
uncommon for a physician to place a catheter somewhere in a vessel
and exchange the first guidewire with one or more secondary
guidewires having progressively stiffer distal ends to prevent
prolapse of the devices placed over the guidewire(s). Yet another
advantage would be having a guidewire stiff enough to be pushed and
yet be directed into branched vessels with minimal torquing. Still
another advantage would be a multi-function device able to carry a
second device that could bore its way through an occlusion.
[0009] Vascular occlusions defined as Chronic Total Occulsions are
blockages that can occur anywhere in a patient's vascular system,
including coronary, carotid, renal, iliac, femoral, cerebral,
popliteal and other peripheral arteries.
[0010] U.S. Pat. No. 4,676,249 to Arenas discloses a guidewire
having a moving internal member to provide stiffness when required,
but does not disclose a directable distal end or the ability to
cross occlusions. Another U.S. Pat. No. 5,542,434, discloses a
longitudinally movable core wire made of a memory metal alloy that
stiffens when subjected to thermal energy. This allows the wire to
become stiff and yet torquable when desired, but fails when a
catheter needs to be slid over the device. Both devices are
deficient when they reach an occlusion with heavily calcified
plaque in that they do not have the ability to bore through the
occlusion.
[0011] Using a conventional guidewire to reach the occlusion
requires a catheter to be pushed over the guidewire, the final
guidewire removed and then another device to be pushed through the
catheter and used to cross the blockage. Such devices are generally
known as percutaneous transluminal thrombectomy or artherectomy
devices. These devices have various means to cross the occlusion
and are singular devices lacking the ability to solely navigate the
vasculature. As an example, one such device is disclosed in U.S.
Pat. No. 6,945,951 and describes a thrombectomy catheter using high
velocity saline through jets that erode away the blockage and cross
an occlusion.
[0012] For all these and other reasons there is a clear need for a
single device that can vary its distal end, is relatively stiff,
has the ability to cross an occlusion and/or a feature that can
drill or bore its way through an occlusion.
SUMMARY
[0013] In one aspect, the invention is directed to a vascular
device including a shaft defining a longitudinal dimension, a lumen
allowing fluid communication through the shaft extending along the
longitudinal dimension and a proximal section and a distal section.
The distal section further defines a weak side and a strong side
and an actuating member is attached to the distal section, with the
actuating member being capable of transmitting longitudinal force
to the distal section. When longitudinal force is applied to the
actuating member, the weak side of the distal section increases in
size while the strong side maintains substantially the same size,
resulting in the distal section deflecting.
[0014] In another aspect, the invention is directed to a vascular
device including a shaft defining a lateral dimension, a
longitudinal dimension, a proximal section, a distal section having
greater flexibility than the proximal section and a lumen allowing
access through the shaft extending along the longitudinal
dimension. The shaft at least partly defines a coil, and the coil
further defines a distal end. An actuating member is attached to
the coil, and is capable of transferring longitudinal force to the
coil. A side of the coil winds is physically connected, defining a
connected side, which maintains the coil winds on the connected
side in a constant configuration preventing differential spacing
resulting from the application of longitudinal force and causing
the connected coil winds to have a predetermined configuration in
an unstressed state. When longitudinal force is applied to the
actuating member, an unconnected side of the coil winds expands,
resulting in the vascular device assuming a stressed configuration
having a different shape than the vascular device in the unstressed
configuration.
[0015] In a further aspect the invention is directed to a vascular
device, including a shaft defining a lateral dimension, a
longitudinal dimension, a proximal section, a distal section having
greater flexibility than the proximal section and a lumen allowing
access through the shaft extending along the longitudinal
dimension. The shaft at least partly defines a coil, with the coil
further defining a distal end. A flexible cutting shaft extends
through the lumen and defines a proximal end and a distal end, with
a cutting burr attached to the distal end of the cutting shaft. An
actuating member is attached to the coil and is capable of
transferring longitudinal force to the coil. A side of the coil
winds is physically connected and defines a connected side, which
maintains the coil winds on the connected side in a constant
configuration preventing differential spacing resulting from the
application of longitudinal force and causing the connected coil
winds to have a predetermined configuration in an unstressed state.
When longitudinal force is applied to the actuating member an
unconnected side of the coil winds expands, resulting in the
vascular device assuming a stressed configuration having a
different shape than the vascular device in the unstressed
configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a cross sectional centerline view taken along the
longitudinal axis of a vascular device of the present invention
having a hollow actuating member.
[0017] FIG. 1A is a cross sectional centerline view taken along the
longitudinal axis of the vascular device of FIG. 1, in a deflected
configuration, following the application of distal force to the
actuating member.
[0018] FIG. 1B is a cross sectional centerline view taken along the
longitudinal axis of the vascular device of FIG. 1, in a deflected
configuration, following the application of proximal force to the
actuating member.
[0019] FIG. 1C is a lateral cross section view of the guidewire of
FIG. 1 taken through the lines 1C-1C, illustrating the locations of
the non-expandable side and expandable side.
[0020] FIG. 2 is a cross sectional centerline view taken along the
longitudinal axis of a vascular device of the present invention
with a hollow conduit extending the length of the device and having
a fibrous polymer or metal actuating member.
[0021] FIG. 2A is a cross sectional centerline view of the
embodiment of the vascular device of FIG. 2 in a deflected
configuration following the application of proximal force.
[0022] FIG. 2B is a lateral cross section view of the guidewire of
FIG. 2 taken through the lines 2B-2B, illustrating the locations of
the non-expandable side and expandable side.
[0023] FIG. 3 is a cross sectional centerline view taken along the
longitudinal axis of an alternative embodiment of the vascular
device having a hollow actuating member, a handle and a cutting
burr.
[0024] FIG. 3A is a cross sectional centerline view of the
embodiment shown in FIG. 3 in a deflected configuration following
the application of distal force.
[0025] FIG. 3B is a cross sectional centerline view of the
embodiment shown in FIG. 3 in a deflected configuration following
the application of proximal force.
[0026] FIG. 3C is a lateral cross section view of the guidewire of
FIG. 3 taken through the lines 3C-3C, illustrating the locations of
the non-expandable side and expandable side.
[0027] FIG. 4 is a cross sectional centerline view taken along the
longitudinal axis of an alternative embodiment of the vascular
device having a hollow actuating member, a handle and a cutting
head which are covered by a sheath.
[0028] FIG. 4A is a side plan view of an embodiment of the vascular
device shown in FIG. 4.
[0029] FIG. 4B is a cross sectional centerline view of the
embodiment shown in FIG. 4 in a deflected configuration following
the application of distal force.
[0030] FIG. 4C is a cross sectional centerline view of the
embodiment shown in FIG. 4 in a deflected configuration following
the application of proximal force.
[0031] FIG. 4D is a lateral cross section view of the guidewire of
FIG. 4 taken through the lines 4D-4D, illustrating the locations of
the non-expandable side and expandable side.
[0032] FIG. 5A shows the vascular device of FIG. 3 in use following
introduction into a patient, approaching an obstruction at the
onset of treatment.
[0033] FIG. 5B shows the vascular device of FIG. 3 in use during
treatment.
[0034] FIG. 5C shows the vascular device of FIG. 3 in use following
completion of treatment.
[0035] FIG. 5D shows the vascular device of FIG. 3 in use with the
vascular device contained in a catheter used to aspirate debris
from the treatment site.
[0036] FIG. 5E shows a vascular device similar to that shown in
FIG. 4, having an angled cutting shaft, in use during
treatment.
DETAILED DESCRIPTION
[0037] Nomenclature [0038] 50 Catheter [0039] 400 Vascular Device
[0040] 402 Hollow Shaft [0041] 402a Proximal Termination of Hollow
Shaft [0042] 402b Distal Termination of Hollow Shaft [0043] 404
Actuating Member [0044] 406 Coil [0045] 406a Open Wound Coil
Section [0046] 406b Solid Coil Section [0047] 407 Distal Section
[0048] 408 Weld [0049] 410 Distal Lumen Opening [0050] 412 Proximal
End of Solid Coil Section [0051] 414 First Lumen [0052] 416 Second
Lumen [0053] 418 Ribbon [0054] 420 Cutting Head [0055] 422 First
Handle [0056] 423 Third Handle [0057] 424 Cutting Shaft [0058] 424a
Proximal End of Cutting Shaft [0059] 424b Distal End of Cutting
Shaft [0060] 425 Second Handle [0061] 426 Flattened Section of Coil
[0062] 428 Solder [0063] 430 Non-Expandable Side [0064] 432
Expandable Side [0065] 500 Vascular Device [0066] 502 Hollow Shaft
[0067] 504 Actuating Member [0068] 505 Sheath [0069] 506 Distal End
(of Vascular Device) [0070] 508 Slit [0071] 510 Coil [0072] 510a
Open Wound Coil Section [0073] 510b Solid Coil Section [0074] 512
Weld [0075] 514 First Lumen [0076] 516 Second Lumen [0077] 517
Distal Section [0078] 518 Ribbon [0079] 520 Cutting Head [0080] 524
Cutting Shaft [0081] 524a Proximal End of Cutting Shaft [0082] 524b
Distal End of Cutting Shaft [0083] 526 Flattened Section of Coil
[0084] 528 Solder [0085] 530 Non-Expandable Side [0086] 532
Expandable Side [0087] 534 First Handle [0088] 536 Second Handle
[0089] 600 Vascular Device [0090] 602 Coating [0091] 604 Actuating
Member [0092] 606 First Lumen [0093] 608 Coil [0094] 610 Second
Lumen [0095] 612 Ribbon [0096] 614 Open Coil Section [0097] 615
Flattened Section of Coil [0098] 616 Distal Closed Coil Section
[0099] 617 Distal Section (of Vascular Device) [0100] 618 Actuating
Member Attachment [0101] 620 Distal First Lumen Opening [0102] 622
Non-Expandable Side [0103] 624 Expandable Side [0104] 626 Handle
[0105] 628 Proximal Closed Coil Section [0106] 718 Cutting Shaft
[0107] 720 Cutting Head [0108] 722 Angle in Cutting Shaft [0109]
1000 Vascular Vessel [0110] 1002 Vascular Obstruction [0111] 1002a
Attached Obstruction [0112] 1002b Obstruction Debris [0113] 1400
Vascular Device [0114] 1410 Central Space [0115] 1412 Distal
Section [0116] 1412a Loose Wound Section [0117] 1412b Tight Wound
Section [0118] 1414 Coil [0119] 1415 Proximal Coil Section [0120]
1416 Flattened Section of Coil [0121] 1418 Ribbon [0122] 1420
Hollow Member [0123] 1422 Lumen [0124] 1424 Solder [0125] 1426
Coating [0126] 1428 Distal End of Vascular Device [0127] 1429
Proximal End of Coil [0128] 1430 Actuating Member [0129] 1432
Actuating Member Attachment [0130] 1434 Distal End of Coil [0131]
1436 Distal Lumen Opening [0132] 1438 Non-Expandable Side [0133]
1440 Expandable Side [0134] 1442 Handle
[0135] Definitions
[0136] "Anatomical Conduit" refers to a naturally occurring vessel
or duct within a patient's body.
[0137] "Distal" means further from the point controlled by the
operator (e.g., physician or technician) of a device.
[0138] "Distal Force" means force applied in a distal direction or
toward a distal end of the device.
[0139] "ePTFE" means expanded polytetrafluoroethylene.
[0140] "FEP" means fluorinated ethylene-propylene.
[0141] "Handle" means a device used to grip certain components of
the invention for the purpose of causing longitudinal movement of
additional components.
[0142] "Longitudinal Force" means either distal force or proximal
force.
[0143] "Prolapse" refers to an adverse event occurring when a
medical device does not follow the desired path at a vascular
bifurcation but instead where a relatively stiff device forces a
relatively less stiff device straight through the vessel, pulling
the less stiff device out of the side branch of the
bifurcation.
[0144] "Proximal" means closer to the point controlled by the
operator (e.g., physician or technician) of a device.
[0145] "Proximal Force" means force applied in a proximal direction
or toward a proximal end of the device.
[0146] "PTFE" means polytetrafluoroethylene.
[0147] Construction
[0148] The following detailed description is to be read with
reference to the drawings in which similar components in different
drawings have the same nomenclature. The drawings, which are not
necessarily to scale, show illustrative embodiments and are not
intended to limit the scope of the invention.
[0149] It should be noted that combinations of materials and
components described within this specification may be
interchangeable and anyone skilled in the art will understand that
a combination of materials or exchange of other materials to
accomplish the work of the invention will not depart from the
spirit of the invention. It is further understood that the
invention is not limited to vascular use and can also be applied to
use through an endoscope, gastroenterological procedures,
laparoscope, artherectomy procedures, urological procedures or
neurological procedures.
[0150] For the purpose of describing the actuation of the
embodiments of the invention 600, 1400 as described below, a handle
626, 1442 is used. The function of the handle 626, 1442 is to
contact the coated coil 608, 1414, move the actuating member 604,
1430 and provide greater control to the operator. Using the handle
626, 1442 allows the application of a longitudinal force (distal or
proximal) from a proximal end (unnumbered) of the device 600, 1400
to the attached actuating member 604 and proximal force to the
actuating member 1430, which causes a sliding motion. As described
in detail below, the application of longitudinal force causes a
distal section 617, 1412 of the vascular device 600, 1400 to
deflect. In the cases of the embodiments of the invention 400, 500
a first handle 422, 534, contacts the hollow shaft 402, 502 and is
attached to the actuating member 404, 504 allowing longitudinal
force to be applied to the distal section 407, 517, causing it to
deflect. A second handle 425, 536 is attached to a cutting head
420, 520 which distally extends from a distal lumen opening 410 or
a sheath 505 and manually rotated in procedures requiring plaque
removal.
[0151] FIG. 1 shows a cross sectional centerline view taken along
the longitudinal axis of a vascular device 600 having a first lumen
606 and a second lumen 610. The vascular device 600 can be used as
a guidewire or a catheter or as a combination of the two. The
presence of a first lumen 606 and a second lumen 610 allows the
device 600 to function as an aspiration device as well as a
catheter so that during a medical procedure it can be
simultaneously used to deliver other medical devices to a remotely
navigated anatomical site and to aspirate fluids. The device 600
can also be used for the delivery of therapeutic fluids through the
first lumen 606 to remote anatomical sites following navigation
using the device 600 as a guidewire. The device 600 includes a coil
608 defining a proximal open coil section 614 and a distal closed
coil section 616. A proximal closed coil section 628 extends
proximally of a distal coil section 617 and is wound in a
relatively closed coil configuration similar to the distal closed
coil section 616. In one embodiment, the coil 608 can be made from
a radiopaque material such as a platinum-nickel alloy that allows
the physician to visualize the position of the coil 608 using
radiological means, thereby navigating the vascular device 600 into
desired anatomical pathways with minimal forward motion. In a
manner similar to the other embodiments of the invention 400, 500
the device 600 is capable of deflecting by applying longitudinal
force to an actuating member 604 which causes the expandable side
624 of the coil 608 to expand while the non-expandable side 622 is
prevented from expanding by being fixedly attached to a ribbon 612
as explained below. The actuating member 604 can be made from a
variety of materials having sufficient strength to be able to cause
the distal section 617 to deflect and still be flexible enough to
move with the coil 608, including but not limited to stainless
steel alloys, nickel titanium alloys and reinforced polymeric
materials such as Kevlar.RTM. or fabric materials. An outer polymer
coating 602 covers the device 600 to the proximal point of
attachment (unnumbered) of the ribbon 612, leaving the open coil
section 614 exposed. The ribbon 612 is attached to the open coil
section 614 at a flattened section 615. Means of attaching the
ribbon 612 include but are not limited to adhesives, laser welding,
or soldering. When negative pressure is applied to the second lumen
610 the device 600 can be used as an aspiration device to remove
fluid or debris through the spaces between the open coil section
614, from an anatomical location the device 600 has been navigated
to. The distal closed coil section 616 is close or tight wound and
forms an area 618 for attaching a hollow actuating member 604. The
actuating member 604 can be made from a variety of materials having
sufficient strength to be able to cause the distal section 617 to
deflect and still be flexible to flex enough to curve with the coil
608, including but not limited to stainless steel alloys, nickel
titanium alloys and reinforced polymeric materials such as
Kevlar.RTM. or fabric materials. The first lumen 606 which extends
through the center of the actuating member 604 can also be used for
aspirating fluids or debris when negative pressure is applied to
the first lumen 606. Likewise, the first lumen 606 can be used for
delivery of drugs or therapeutic fluids when positive pressure is
applied. A coating 602 such as non-thrombogenic polymers, PTFE,
ePTFE, FEP, polyester, polyurethane, polyethylene, silicone or
hydrophilic may be applied over the proximal section (unnumbered)
of the coil 608 to improve sterility as well as enhancing the outer
smoothness of the guidewire 600, thereby causing less trauma to the
patient during introduction, the procedure itself and removal. In
one embodiment the coating 602 is applied to the coil 608 by
applying a polymer heat shrink tubing such as a PTFE, FEP, or
polyester, followed by the application of a proper amount of heat
or an appropriate length of time. In additional embodiments the
coating 602 is applied by dipping the guidewire 600 into a
dispersion polymer such as urethane or silicone, by spraying a
polymer such as PTFE, FEP, polyester or silicone or by a
co-extrusion process of a polymer such as PTFE, FEP, polyester,
urethane or silicone. An additional advantage of a coating 602 is a
reduction in adverse reactions due to adhesion of platelets,
proteins, cells or other fouling materials, which can cause fibrin
clot production.
[0152] When distal force is applied to the actuating member 604 by
the operator, as shown in FIG. 1A, the distal section 617 deflects
due to the non-expandable side 622 to which the ribbon 612 is
attached being prevented from expanding while allowing the
expandable side 624 to expand, resulting in the distal section 617
assuming a deflected configuration as best shown in FIG. 1A. As
shown in FIG. 1B, if proximal force is applied to the actuating
member 604 the distal section 617 is deflected in another direction
than when distal force is applied. This is due to the pitch of the
open wound coil section 614 having a relatively loose or open pitch
to the coil winds (unnumbered), which allows the coil winds
(unnumbered) on the expandable side 624, to be forced into a closer
configuration. If the actuating member 604 is coupled with an
actuating mechanism (not shown) such as a vernier type mechanism
(not shown) a predictable and variable amount of deflection can be
achieved with the application of a given amount of longitudinal
force. FIG. 1C shows a lateral cross section of the vascular device
600 taken through the lines 1C-1C and illustrates the locations of
the non-expandable side 622 and expandable side 624.
[0153] FIG. 2 is a cross sectional centerline view taken along the
longitudinal axis of a vascular device 1400 of the present
invention having a fibrous actuating member 1430 or metal actuating
member (not shown) attached 1432 to a distal end 1434 of a coil
1414 enabling the vascular device 1400 to deflect to an alternative
shape upon proximal force being applied to the actuating mechanism
1430. The vascular device 1400 can be used as a guidewire or a
catheter or as a combination of the two. The device 1400 includes a
coil 1414 defining a distal section 1412, further defining a loose
wound section 1412a and a tight wound section 1412b. A proximal
coil section 1415 extends proximally of the distal coil section
1412 and may be wound in a relatively closed coil configuration
similar to the tight wound section 1412b. In one embodiment, the
coil 1414 can be made from a radiopaque material such as a
platinum-nickel alloy that allows the physician to visualize the
position of the coil 1414 using radiological means, thereby
navigating the vascular device 1400 into desired anatomical
pathways with minimal forward motion. The coil 1414 extends between
a distal end 1434 and a proximal end 1429 and defines a central
space 1410 inside the coil winds. The coil 1414 defines a flattened
section 1416 towards the distal end 1434 which is configured to
receive a ribbon 1418 which is affixed to the coil 1414. The ribbon
1418 is made of a suitable metallic material such as austenitic
stainless steel alloy or a tungsten alloy such as
tungsten-molybdenum and tungsten-rhenium. In some instances,
iridium is added to the alloy to increase strength and
radiopaqueness. In another embodiment (not shown) the ribbon 1418
is not used and instead the deflectable distal section 1412 is
defined by a series of welds (not shown), gluing (not shown) or
mechanical fasteners (not shown) affixed to the coil winds. In an
alternative embodiment (not shown), the ribbon 1418 is replaced by
the application of a polymer fiber fused to coil 1414. The fiber
(not shown) is entangled into the coil 1414 by means of weaving in
and out of the coil winds and looping around the individual coil
winds to form a solid attachment after application of an adhesive.
The ribbon 1418 (or other means of securing) functions to bind
together the portions of the coil 1414 to which it is attached to
form a non-expandable side 1438 as best shown in FIG. 2B. Means of
attaching the ribbon 1418 to the flattened section 1416 include but
are not limited to adhesives, laser welding, or soldering. Thus,
when proximal force is applied to the actuating member 1430 by the
operator, the distal section 1412 will deflect due to the
non-expandable side 1438 of the coil 1414 to which the ribbon 1418
is attached being prevented from expanding while allowing the
expandable side 1440 to expand, resulting in the distal section
1412 deflecting from a straight configuration. If the actuating
member 1430 is coupled with an actuating mechanism (not shown) such
as a vernier type mechanism (not shown) a predictable and variable
amount of deflection can be achieved with the application of a
given amount of proximal force. It is also observed that along the
distal section 1412 the coil 1414 defines a loose wound section
1412a where it is wound at a lesser or looser pitch than the
remainder of the coil 1414, imparting a greater degree of
flexibility to the distal section 1412. Attached by solder 1424 or
other means to the coil 1414 at the distal end 1428 is a hollow
member 1420 which resides inside the central space 1410 and extends
the length of the vascular device 1400. The hollow member 1420
functions to add stiffness and stability to the vascular device
1400, while also defining a lumen 1422 which can be used for such
purposes as drug delivery, aspiration or as a general catheter. The
hollow member 1420 can be made from a variety of materials having
sufficient strength to be able to cause the distal section 1412 to
deflect and still be flexible enough to move with the coil 1414,
including but not limited to stainless steel alloys, nickel
titanium alloys and reinforced polymeric materials such as
Kevlar.RTM. or fabric materials. The actuating member 1430 can be
made of a polymeric material such as Kevlar.RTM. or other suitable
metallic material such as stainless steel and is attached by solder
1424 or other means to the distal end 1434 of the coil 1414 and
routed through the central space 1410 so as to be able to apply
proximal force to the distal section 1412, allowing an operator to
precisely deflect the distal section 1412 thereby enhancing the
steerability and overall maneuverability of the vascular device
1400. A coating 1426 such as non-thrombogenic polymers, PTFE,
ePTFE, FEP, polyester, polyurethane, polyethylene, silicone or
hydrophilic may be applied over the coil 1414 to improve sterility
as well as enhancing the outer smoothness of the guidewire 1400,
thereby causing less trauma to the patient during introduction, the
procedure itself and removal. In one embodiment the coating 1426 is
applied to the coil 1414 by applying a polymer heat shrink tubing
such as a PTFE, FEP, or polyester, followed by the application of a
proper amount of heat or an appropriate length of time. In
additional embodiments the coating 1426 is applied by dipping the
guidewire 1400 into a dispersion polymer such as urethane or
silicone, by spraying a polymer such as PTFE, FEP, polyester or
silicone or by a co-extrusion process of a polymer such as PTFE,
FEP, polyester, urethane or silicone. An additional advantage of a
coating 1426 is a reduction in adverse reactions due to adhesion of
platelets, proteins, cells or other fouling materials, which can
cause fibrin clot production.
[0154] As shown in FIG. 2A, if proximal force is applied to the
actuating member 1430 the distal section 1412 is deflected. This is
due to the expandable side 1440 being able to expand while the
non-expandable side 1438 is prevented from expanding. If the
actuating member 1430 is coupled with an actuating mechanism (not
shown) such as a vernier type mechanism (not shown) a predictable
and variable amount of deflection can be achieved with the
application of a given amount of longitudinal force. FIG. 2B shows
a lateral cross section of the vascular device 1400 taken through
the lines 2B-2B and illustrates the locations of the non-expandable
side 1438 and expandable side 1440.
[0155] FIG. 3 shows a vascular device 400 which can be used as a
guidewire or a catheter or as a combination of the two. A hollow
shaft 402 defines a first lumen 414 into which is fitted an
actuating member 404 which is itself hollow and defines a second
lumen 416. The hollow shaft 402 is proximally attached to a first
handle 422 which, as described above, is used to contact the device
400 as a whole. A third handle 423 is attached to the actuating
member 404 which provides longitudinal control over the position of
the actuating member 404. The hollow shaft 402 provides strength
and support to the vascular device 400 and defines a proximal
termination 402a, which is mounted within the first handle 422, and
a distal termination 402b. The hollow shaft 402 and actuating
member 404 can be made from a variety of materials having
sufficient strength to be able to cause the distal section 407 to
deflect and still be flexible enough to move with a coil 406,
including but not limited to stainless steel alloys, nickel
titanium alloys and reinforced polymeric materials such as
Kevlar.RTM. or fabric materials. The coil 406 defines an open wound
section 406a which is attached to and extends distally from the
distal termination 402b of the hollow shaft 402 to the proximal end
412 of a solid coil section 406b. The open wound section 406a is
further defined by the attachment of a ribbon 418 which in one
embodiment is attached to a flattened section 426 of the coil 406.
Means of attaching the ribbon 418 include but are not limited to
adhesives, laser welding, or soldering. In one embodiment, the coil
406 can be made from a radiopaque material such as a
platinum-nickel alloy that allows the physician to visualize the
position of the coil 406 using radiological means, thereby
navigating the vascular device 400 into desired anatomical pathways
with minimal forward motion. The vascular device 400 defines a
deflectable distal section 407 such that when longitudinal force is
applied to the actuating member 404 by the operator, the distal
section 407 deflects as a result of preventing the non-expandable
side 430, to which the ribbon 418 is attached, from expanding,
while allowing the expandable side 432 to expand, resulting in the
distal section 407 assuming a deflected configuration as best shown
in FIGS. 3A and 3B. The ribbon 418 is made of a suitable metallic
material such as austenitic stainless steel alloy or a tungsten
alloy such as tungsten-molybdenum and tungsten-rhenium. In some
instances, iridium is added to the alloy to increase strength and
radiopaqueness. In another embodiment (not shown) the ribbon 418 is
not used and instead the deflectable distal section 407 is defined
by a series of welds (not shown), gluing (not shown) or mechanical
fasteners (not shown) affixed to the coil winds. In an alternative
embodiment (not shown), the ribbon 418 is replaced by the
application of a polymer fiber fused to the open wound coil section
406a. The fiber (not shown) is entangled into the open wound coil
section 406a by means of weaving in and out of the coil winds and
looping around the individual coil winds to form a solid attachment
after application of an adhesive. The solid, distally located
section 406b of the coil 406 is created by the presence of welds
408 between the individual coil winds (unnumbered) which function
to prevent flexing of the solid section 406b from the application
of longitudinal force. The solid coil section 406b terminates at a
distal lumen opening 410 which is in fluid communication with the
second lumen 416 and can thus be used to either deliver or aspirate
substances from the anatomical area accessed by the device 400. The
actuating member 404 extends proximally from the first handle 422
allowing access to the second lumen 416 and distally to the
junction between the open wound section 406a and solid section 406b
of the coil 406, where it is attached by solder 428. Extending
through the second lumen 416 is a rotatably mounted, flexible
cutting shaft 424, defining a proximal end 424a and a distal end
424b which terminates distally with a cutting burr 420 mounted
thereon which is used to remove plaque or clots from a vessel. A
second handle 425 is distally attached to the cutting shaft 424 and
is manually rotated by the physician as needed, resulting in the
cutting burr 420 simultaneously rotating. Flexibility of the
cutting shaft 424 is preferably provided by making it of
superelastic nitinol, but it is also contemplated to be made of
stainless steel, glass-filled polymer or carbon-filled polymer.
[0156] When distal force is applied to the actuating member 404 by
the operator, as shown in FIG. 3A, the distal section 407 deflects
due to the non-expandable side 430 to which the ribbon 418 is
attached being prevented from expanding while allowing the
expandable side 432 to expand, resulting in the distal section 407
assuming a deflected configuration as best shown in FIG. 3A. As
shown in FIG. 3B, if proximal force is applied to the actuating
member 404 the distal section 407 is deflected in the opposite
direction as when distal force is applied. This is due to the pitch
of the open wound coil section 406a having a relatively loose or
open pitch to the coil winds (unnumbered), which allows the coil
winds (unnumbered) on the expandable side 432, to be forced into a
closer configuration. If the actuating member 404 is coupled with
an actuating mechanism (not shown) such as a vernier type mechanism
(not shown) a predictable and variable amount of deflection can be
achieved with the application of a given amount of longitudinal
force. FIG. 3C shows a lateral cross section of the vascular device
400 taken through the lines 3C-3C and illustrates the locations of
the non-expandable side 430 and expandable side 432.
[0157] FIG. 4 is a cross sectional centerline view taken along the
longitudinal axis of an alternative embodiment of the vascular
device 500 which is similar to the embodiment of the vascular
device 400 shown in FIGS. 3-3C, with the addition of a covering
sheath 505. The vascular device 500 can be used as a guidewire or a
catheter or as a combination of the two. The sheath 505 can be
insert molded and surrounds at least the distal section 517 of the
vascular device 500. The sheath 505 functions to make the device
500 more atraumatic, creating a safer device. A distal end 506 of
the sheath 505 defines a range of at least one and up to eight
slits 508 which are impressed across the center axis of the distal
end 506 and which function to enclose a cutting head 520 and
thereby protect delicate anatomical structures during introduction.
When the cutting head 520 or other medical device (not shown) is
deployed the slits 508 will open, becoming flaps (not shown),
allowing the physician to perform a medical procedure, such as
loosening and ultimately removing plaque from the interior surfaces
of artery walls. When the cutting head 520 or other medical device
(not shown) is pulled back into the second lumen 516 following
completion of the procedure, the flaps 508 may close (not shown) or
remain open still enclosing the cutting head 520, allowing the
device 500 to be removed in a manner less likely to cause
additional trauma to the patient.
[0158] As shown in FIG. 4 hollow shaft 502 defines a first lumen
514 into which is fitted an actuating member 504 which is itself
hollow and defines a second lumen 516. The hollow shaft 502 and
actuating member 504 are proximally attached to a first handle 534
which is used to contact the device 500 as a whole as well as
allowing longitudinal control over the position of the actuating
member 504. The hollow shaft 502 provides strength and support to
the vascular device 500 as a whole and defines a proximal
termination (unnumbered), which is mounted within the first handle
534. The hollow shaft 502 and actuating member 504 can be made from
a variety of materials having sufficient strength to be able to
cause the distal section 517 to deflect and still be flexible
enough to move with a coil 510, including but not limited to
stainless steel alloys, nickel titanium alloys and reinforced
polymeric materials such as Kevlar.RTM. or fabric materials. The
coil 510 defines an open wound section 510a which is attached to
and extends distally from the distal termination (unnumbered) of
the hollow shaft 502 to a proximal end (unnumbered) of a solid coil
section 510b. The open wound section 510a is further defined by the
attachment of a ribbon 518 which in one embodiment is attached to a
flattened section 526 of the coil 510. Means of attaching the
ribbon 518 include but are not limited to adhesives, laser welding,
or soldering. In one embodiment, the coil 510 can be made from a
radiopaque material such as a platinum-nickel alloy that allows the
physician to visualize the position of the coil 510 using
radiological means, thereby navigating the vascular device 500 into
desired anatomical pathways with minimal forward motion. The
vascular device 500 defines a deflectable distal section 517 so
that when longitudinal force is applied to the actuating member 504
by the operator, the deflectable distal section 517 deflects, as
described in detail below. The ribbon 518 is made of a suitable
metallic material such as austenitic stainless steel alloy or a
tungsten alloy such as tungsten-molybdenum and tungsten-rhenium. In
some instances, iridium is added to the alloy to increase strength
and radiopaqueness. In another embodiment (not shown) the ribbon
518 is not used and instead the deflectable distal section 517 is
defined by a series of welds (not shown), gluing (not shown) or
mechanical fasteners (not shown) affixed to the coil winds. In an
alternative embodiment (not shown), the ribbon 518 is replaced by
the application of a polymer fiber fused to the open wound coil
section 510a. The fiber (not shown) is entangled into the open
wound coil section 510a by means of weaving in and out of the coil
winds and looping around the individual coil winds to form a solid
attachment after application of an adhesive. The solid, distally
located section 510b of the coil 510 is created in this embodiment
by the presence of welds 512 between the individual coil winds
(unnumbered) which function to prevent flexing of the solid section
510b from the application of longitudinal force. The solid coil
section 510b terminates at a distal lumen opening (unnumbered)
which is in fluid communication with the second lumen 516 and can
thus be used to either deliver or aspirate substances from the
anatomical area accessed by the device 500. The actuating member
504 extends proximally from the first handle 534 allowing access to
the second lumen 516 and distally to the junction between the open
wound section 510a and solid section 510b of the coil 510, where it
is attached by solder 528. Extending through the second lumen 516
is a rotatably mounted cutting shaft 524, defining a proximal end
524a and a distal end 524b which terminates distally and is mounted
with a cutting head 520 and is used to remove plaque or clots from
a vessel. A second handle 536 is distally attached to the cutting
shaft 524 and is manually rotated by the physician as needed,
resulting in rotation of the cutting head 520. Flexibility of the
cutting shaft 524 is preferably provided by making it of
superelastic nitinol, but it is also contemplated to be made of
stainless steel, glass-filled polymer or carbon-filled polymer.
[0159] When distal force is applied to the actuating member 504 by
the operator, as shown in FIG. 4B, the distal section 517 deflects
due to the non-expandable side 530 to which the ribbon 518 is
attached being prevented from expanding while allowing the
expandable side 532 to expand, resulting in the distal section 517
assuming a deflected configuration as best shown in FIG. 4B. As
shown in FIG. 4C, if proximal force is applied to the actuating
member 504 the distal section 517 is deflected in another direction
as when distal force is applied. This is due to the pitch of the
open wound coil section 510a having a relatively loose or open
pitch to the coil winds (unnumbered), which allows the coil winds
(unnumbered) on the expandable side 532, to be forced into a closer
configuration. If the actuating member 504 is coupled with an
actuating mechanism (not shown) such as a vernier type mechanism
(not shown) a predictable and variable amount of deflection can be
achieved with the application of a given amount of longitudinal
force. FIG. 4D shows a lateral cross section of the vascular device
500 taken through the lines 4D-4D and illustrates the locations of
the non-expandable side 530 and expandable side 532.
[0160] FIG. 5A shows the vascular device 400 as shown in more
detail in FIG. 3 in use following introduction into a patient,
approaching an obstruction 1002 at the onset of treatment. It is
seen that the device 400 has been navigated to the obstruction 1002
in a vessel 1000 which requires opening. Cutting head 420 has been
deployed from the second lumen 416 to eventually bore through the
obstruction 1002 and it is observed that the distal end (unnumbered
this figure) of the device 400 is in the deflected configuration as
a result of applying distal force to the actuating member 404 which
allows the device to be precisely navigated through a tortuous
vascular pathway.
[0161] FIG. 5B shows the vascular device 400 in use during the
beginning of treatment. It is seen that the deployed cutting head
420 is being rotated and contacting the obstruction 1002. It is
further seen that some of the obstruction 1002b has been detached
from its main body following treatment.
[0162] FIG. 5C shows the vascular device 400 in use following
completion of treatment. It is seen that the obstruction 1002 has
been crossed and that some obstruction 1002a remains attached to
the vessel 1000 wall while other obstruction 1002b is detached and
has been removed.
[0163] FIG. 5D shows the vascular device 400 in use following
introduction into a patient, approaching an obstruction 1000 at the
onset of treatment, with the vascular device 400 contained in a
catheter 50 used to aspirate debris from the treatment site.
[0164] FIG. 5E shows a vascular device 500 similar to that shown in
FIG. 4 with an additional difference being a predetermined angle
722 formed into the cutting shaft 718. It is seen that the deployed
cutting head 720 extends from the slit 508 at the distal end 506 of
the sheath 505 and is being rotated and contacting the obstruction
1002. The angle 722 confers the advantage of allowing the physician
to rotate the proximal end (not shown) of the actuating member (not
shown) causing the cutting head 720 to move in an elliptical path
around the inner walls of the vessel 1000, cutting and removing
obstruction 1002. This allows the sheath 505 to remain stationary
and not rotated by the physician. A consistent deflection can be
maintained on the distal end 506 of the vascular device 500 and
held in the center axis of the vessel 1000. This advantage also
reduces the amount of vascular damage caused by required rotating
of conventional guidewires or cutting devices by the physician in
the process of navigating the device 500 through vascular
obstructions.
[0165] The outer diameter of the vascular device 400, 500, 600,
1400 is manufactured to dimensions that are industry standards for
certain medical procedures and can range from between approximately
0.006 inch to 0.121 inch which allows passage through a ten French
catheter at 0.131 inch outer diameter, as an example. The length of
the vascular device 400, 500, 600, 1400 is similarly manufactured
to conform to industry standards and may range between
approximately 10 centimeters to 300 centimeters as required by the
particular medical procedure.
[0166] Use
[0167] Using the vascular device 400, 500, 600, 1400 of the present
invention first requires removal from sterile packaging. Standard
surgical techniques are employed to incise the proper blood vessel
or bodily duct using an introducer having one or more sealed ports.
The introducer can range in diameter from 4 to 24 French depending
on the vessel or bodily duct size and location. Most procedures
performed for Percutaneous Transluminal Coronary Angioplasty (PTCA)
use a 6 to 10 French device passing through the introducer. A 6 to
10 French catheter having an open and blunt distal end can cause
vascular damage passing through the vessels. Therefore one
embodiment of the invention described herein discloses a rounded,
bulleted distal end. The introducer is placed into the vessel lumen
and is followed by insertion of a guidewire, catheter or other
medical device that can pass transluminally through the vessel to
the site of therapy. A rounded distal end will facilitate this task
with less vascular damage.
[0168] The vascular device 400, 500, 600, 1400 is then inserted
into the introducer and carefully navigated through the patient's
vasculature until the treatment site is reached. At that point,
either the vascular device 400, 500, 600, 1400 is used to complete
the procedure or another device is passed over or through the
vascular device 400, 500, 600, 1400. At the completion of the
procedure the vascular device 400, 500, 600, 1400 is disposed
of.
[0169] In the embodiments 400, 500 as described above, the
invention may be employed as a combination guidewire and
thrombectomy or atherectomy device to remove calcified plaque or
venous thrombosis. When these embodiments of the vascular device
400, 500 are used the physician places the distal end 410, 506 near
the obstruction and a radio opaque contrast material may be
injected into the artery through a lumen in the device, after which
the physician advances a second handle 425, 536 at the proximal end
(unnumbered) to deploy the cutting head 420, 520 at the distal end
410, 506 and slowly advance the device while manually rotating the
second handle 425, 536. Aspiration may be used to remove the debris
detached and displaced by the cutting head 420, 520. Upon
completion of the procedure, the vascular device 400, 500 is
removed and disposed of. These embodiments allow the physician to
navigate a single device to the diseased area and complete the
procedure in the shortest time with the least amount of vascular
damage.
[0170] While the invention as described above can be used as a
combination guidewire/thrombectomy/atherectomy device, it can also
be used a catheter. Most transfemoral coronary catheterization
employ between a 4 and 10 French catheter. Small arteries will
utilize around a 4 French catheter while larger arteries could
utilize up to a 10 French catheter. Cited by the Journal of the
American Medical Association, upward of three million cardiac
catheterizations are performed annually in the United States. A
device to reduce procedural time vascular damage would be an
economic advantage to the industry. The vascular device 400, 500,
600, 1400 may be applied to a variety of medical devices capable of
being introduced into the vasculature or other anatomy of a
patient. For example, the vascular device 400, 500, 600, 1400 could
be applied to singular guidewires, guidewire/catheter combination
(e.g., balloon angioplasty, stent deliver, drug delivery, fluid
delivery or fluid removal), as a conduit for atherectomy devices
and NUS catheters, laparoscopic and endoscopic devices, spinal or
cranial navigation devices, neurostimulation and cardiac
resynchronization leads, embolic protection devices, therapeutic
devices and other medical devices. When used for drug delivery the
invention finds utility by being able to remove fluid causing the
surrounding area to lose excess fluid. A drug can then be injected
and the affected area will more readily absorb the drug by the
osmotic difference in pressure. This allows the drug to remain at
the site rather than be carried away by the movement of
interstitial fluids.
[0171] The vascular device 600, 1400 finds further utility in the
implantation of neurostimulation or resynchronization leads which
are typically 30 to 60 cm long. Currently these leads must include
a large lumen for the insertion of a preformed stylet to steer the
lead to the target site. As the industry continues to reduce the
diameter of these leads to 4.1 French or less by removing the
stylet lumen, a device is needed to steer the leads to the target
site and allow the physician to rotate the lead (not shown) at the
proximal end to implant the lead. The vascular device 600, 1400
accomplishes this by providing an open lumen from the proximal end
(unnumbered) to the distal end 620, 1436 while allowing the distal
end 620, 1436 to be manipulatively deflected by the physician and
the proximal end of the lead manually rotated. Following
implantation of the lead the invention is removed and disposed
of.
* * * * *