U.S. patent application number 11/491346 was filed with the patent office on 2007-03-08 for method of treating a hollow anatomical structure with a thermal catheter.
Invention is credited to Brian Eugene Farley, Robert Gordon McRae, Russell Blake Thompson, Arthur Wayne Zikorus.
Application Number | 20070055326 11/491346 |
Document ID | / |
Family ID | 42118194 |
Filed Date | 2007-03-08 |
United States Patent
Application |
20070055326 |
Kind Code |
A1 |
Farley; Brian Eugene ; et
al. |
March 8, 2007 |
Method of treating a hollow anatomical structure with a thermal
catheter
Abstract
A working end of a catheter includes at least one therapeutic
element, such as a resistive heating element, usable to deliver
energy for ligating, or reducing the diameter of, a hollow
anatomical structure. In certain examples, the catheter includes a
lumen to accommodate a guide wire or to allow fluid delivery. In
certain embodiments, a balloon is inflated to place resistive
element(s) into apposition with a hollow anatomical structure and
to occlude the structure. Indexing devices and methods are also
disclosed for successively treating portions of the hollow
anatomical structure. In certain examples, marks along the catheter
shaft provide visual verification to the physician of the relative
position of the therapeutic element of the catheter. Embodiments of
indexing devices may include pairs of rings and/or hinged arms that
move a catheter a desired indexed position between successive
treatments.
Inventors: |
Farley; Brian Eugene; (Los
Altos, CA) ; Thompson; Russell Blake; (Los Altos,
CA) ; Zikorus; Arthur Wayne; (San Jose, CA) ;
McRae; Robert Gordon; (San Jose, CA) |
Correspondence
Address: |
KNOBBE MARTENS OLSON & BEAR LLP
2040 MAIN STREET
FOURTEENTH FLOOR
IRVINE
CA
92614
US
|
Family ID: |
42118194 |
Appl. No.: |
11/491346 |
Filed: |
July 21, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60780948 |
Mar 9, 2006 |
|
|
|
60701303 |
Jul 21, 2005 |
|
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Current U.S.
Class: |
607/96 ;
607/89 |
Current CPC
Class: |
A61B 90/39 20160201;
A61B 18/1492 20130101; A61B 2018/046 20130101; A61B 18/24 20130101;
A61B 2017/00119 20130101; A61B 2017/00123 20130101; A61B 2090/3945
20160201; A61B 2017/00026 20130101; A61B 2018/00666 20130101; A61B
2018/00791 20130101; A61B 18/082 20130101; A61B 2017/00132
20130101; A61B 2017/00084 20130101; A61B 2018/00636 20130101; A61B
2018/00827 20130101; A61B 18/20 20130101; A61B 2018/00779 20130101;
A61B 2090/3925 20160201; A61B 2090/3937 20160201; A61B 18/08
20130101; A61B 2090/0811 20160201 |
Class at
Publication: |
607/096 ;
607/089 |
International
Class: |
A61F 7/00 20060101
A61F007/00; A61F 7/12 20060101 A61F007/12; A61N 5/06 20060101
A61N005/06 |
Claims
1. A method of treating a hollow anatomical structure, said method
comprising: inserting an electrically driven heating element into
said hollow anatomical structure, said heating element extending
distally along a longitudinal axis of said element, said heating
element having a length and a width measured orthogonal to said
longitudinal axis, said length being greater than said width;
powering said heating element and thereby causing said heating
element to reach or exceed a minimal treatment temperature; moving
said heating element within said hollow anatomical structure along
a lengthwise direction of said hollow anatomical structure, and
maintaining said heating element at or above said minimal treatment
temperature while moving said heating element along said lengthwise
direction.
2. A method of treating a hollow anatomical structure in accordance
with claim 1, wherein said moving comprises moving said heating
element without stopping along a treatment length of said hollow
anatomical structure, said treatment length being greater than said
heating element length.
3. A method of treating a hollow anatomical structure in accordance
with claim 1, further comprising temporarily stopping or slowing
movement of said heating element when a temperature of said heating
element deviates from a target treatment temperature by more than 3
degrees Celsius.
4. A method of treating a hollow anatomical structure in accordance
with claim 1, wherein said minimal treatment temperature is an
internal temperature of said heating element.
5. A method of treating a hollow anatomical structure in accordance
with claim 1, wherein said minimal treatment temperature is a
temperature measured at or adjacent to said heating element.
6. A method of treating a hollow anatomical structure in accordance
with claim 1, wherein said minimal treatment temperature is
sufficient to cause durable reduction of the diameter of said
hollow anatomical structure.
7. A method of treating a hollow anatomical structure in accordance
with claim 1, wherein said minimal treatment temperature is
sufficient to cause absence of patency of said hollow anatomical
structure.
8. A method of treating a hollow anatomical structure in accordance
with claim 1, further comprising initiating movement of said
heating element after an initial delay after said minimal treatment
temperature is reached.
9. A method of treating a hollow anatomical structure in accordance
with claim 1, wherein said minimal treatment temperature is within
a range of 80-140 degrees Celsius.
10. A method of treating a hollow anatomical structure in
accordance with claim 1, wherein said minimal treatment temperature
is approximately 120 degrees Celsius.
11. A method of treating a hollow anatomical structure in
accordance with claim 1, wherein said minimal treatment temperature
is approximately 95 degrees Celsius.
12. A method of treating a hollow anatomical structure in
accordance with claim 1, wherein said heating element is coupled to
a shaft of a catheter.
13. A method of treating a hollow anatomical structure in
accordance with claim 12, further comprising delivering heated
fluid from a tip of said catheter while moving said heating
element.
14. A method of treating a hollow anatomical structure in
accordance with claim 13, further comprising passing said fluid
through a lumen of said catheter and heating said fluid with said
heating element as said fluid passes through said lumen before said
fluid exits said catheter tip.
15. A method of treating a hollow anatomical structure in
accordance with claim 1, wherein said length of said heating
element is at least equal to fifteen times said width thereof.
16. A method of treating a hollow anatomical structure in
accordance with claim 1, wherein said heating element is a coil
having a variable pitch.
17. A method of treating a hollow anatomical structure in
accordance with claim 12, wherein said heating element extends to a
distal end of said catheter.
18. A method of treating a hollow anatomical structure in
accordance with claim 12, further comprising applying laser light
to said hollow anatomical structure with said catheter.
19. A method of treating a hollow anatomical structure, said method
comprising: inserting an electrically driven heating element into
said hollow anatomical structure, said heating element extending
distally along a longitudinal axis of said element, said heating
element having a length and a width measured orthogonal to said
longitudinal axis, said length being greater than said width;
moving said heating element within said hollow anatomical structure
along a lengthwise direction of said hollow anatomical structure
while applying electrical power to said heating element within a
treatment power level range, and applying power to said heating
element within said treatment power level range while moving said
heating element along said lengthwise direction.
20. A method of treating a hollow anatomical structure in
accordance with claim 19, wherein said moving comprises moving said
heating element without stopping along a treatment length of said
hollow anatomical structure, said treatment length being greater
than said heating element length.
21. A method of treating a hollow anatomical structure in
accordance with claim 19, wherein said treatment power level range
is 20-40W.
22. A method of treating a hollow anatomical structure in
accordance with claim 19, wherein said heating element is coupled
to a shaft of a catheter.
23. A method of treating a hollow anatomical structure in
accordance with claim 22, further comprising delivering heated
fluid from a tip of said catheter while moving said heating
element.
24. A method of treating a hollow anatomical structure in
accordance with claim 23, further comprising passing said fluid
through a lumen of said catheter and heating said fluid with said
heating element as said fluid passes through said lumen before said
fluid exits said catheter tip.
25. A method of treating a hollow anatomical structure in
accordance with claim 19, wherein said length of said heating
element is at least equal to fifteen times said width thereof.
26. A method of treating a hollow anatomical structure in
accordance with claim 19, wherein said heating element is a coil
having a variable pitch.
27. A method of treating a hollow anatomical structure in
accordance with claim 22, wherein said heating element extends to a
distal end of said catheter.
28. A method of treating a hollow anatomical structure in
accordance with claim 22, further comprising applying laser light
to said hollow anatomical structure with said catheter.
29. A method of treating a hollow anatomical structure, said method
comprising: inserting an electrically driven heating element into
said hollow anatomical structure, said heating element extending
distally along a longitudinal axis of said element, said heating
element having a fixed profile in a plane orthogonal to a
longitudinal axis thereof; powering said heating element and
thereby causing said heating element to reach or exceed a minimal
treatment temperature; moving said heating element within said
hollow anatomical structure along a lengthwise direction of said
hollow anatomical structure, and maintaining said heating element
at or above said minimal treatment temperature while moving said
heating element along said lengthwise direction.
30. A method of treating a hollow anatomical structure in
accordance with claim 29, wherein said moving comprises moving said
heating element without stopping along a treatment length of said
hollow anatomical structure, said treatment length being greater
than a length of said heating element.
31. A method of treating a hollow anatomical structure in
accordance with claim 29, wherein said minimal treatment
temperature is sufficient to cause durable reduction of the
diameter of said hollow anatomical structure.
32. A method of treating a hollow anatomical structure in
accordance with claim 29, wherein said minimal treatment
temperature is sufficient to cause absence of patency of said
hollow anatomical structure.
33. A method of treating a hollow anatomical structure in
accordance with claim 29, wherein said heating element is coupled
to a shaft of a catheter.
34. A method of treating a hollow anatomical structure in
accordance with claim 33, further comprising delivering heated
fluid from a tip of said catheter while moving said heating
element.
35. A method of treating a hollow anatomical structure in
accordance with claim 34, further comprising passing said fluid
through a lumen of said catheter and heating said fluid with said
heating element as said fluid passes through said lumen before said
fluid exits said catheter tip.
36. A method of treating a hollow anatomical structure in
accordance with claim 33, further comprising applying laser light
to said hollow anatomical structure with said catheter.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of priority under 35
U.S.C. .sctn.119(e) of each of U.S. Provisional Application No.
60/780,948, filed on Mar. 9, 2006, entitled "SYSTEMS AND METHODS
FOR TREATING A HOLLOW ANATOMICAL STRUCTURE," and U.S. Provisional
Application No. 60/701,303, filed on Jul. 21, 2005, entitled
"RESISTIVE ELEMENT SYSTEM," each of which is hereby incorporated
herein by reference in its entirety and is to be considered a part
of this specification.
BACKGROUND
[0002] 1. Field
[0003] Certain disclosed embodiments relate to methods and
apparatus for applying energy to constrict and/or shrink a hollow
anatomical structure, such as a vein.
[0004] 2. Description of the Related Art
[0005] The human venous system of the lower extremities consists
essentially of the superficial venous system and the deep venous
system with perforating veins connecting the two systems. The
superficial system includes the long or great saphenous vein and
the small saphenous vein. The deep venous system includes the
anterior and posterior tibial veins which unite to form the
popliteal vein, which in turn becomes the femoral vein when joined
by the short saphenous vein.
[0006] The venous system contains numerous one-way valves for
directing blood flow back to the heart. Venous valves are usually
bicuspid Valves, with each cusp forming a sack or reservoir for
blood. Retrograde blood flow forces the free surfaces of the cusps
together to prevent continued retrograde flow of the blood and
allows only antegrade blood flow to the heart. When an incompetent
valve is in the flow path, the valve is unable to close because the
cusps do not form a proper seal, and retrograde flow of the blood
cannot be stopped. When a venous valve fails, increased strain and
pressure occur within the lower venous sections and overlying
tissues, sometimes leading to additional, limb-distal valvular
failure. Two venous conditions or symptoms which often result from
valve failure are varicose veins and more symptomatic chronic
venous insufficiency.
SUMMARY
[0007] Disclosed herein are systems and methods for ligating and/or
substantially occluding a hollow anatomical structure (HAS), such
as, for example, a vein. In particular, certain disclosed
embodiments include devices having a therapeutic element, such as a
resistive heating element, that is capable of directly applying
energy to the inner wall of the hollow anatomical structure. In
certain embodiments, this application of energy causes collagen
denaturation and shrinkage such that the HAS diameter is
substantially reduced and the HAS wall becomes thickened such that
the end result is generally a HAS "lumen" filled with fibrin
whereas fluid can no longer flow therethrough. Also disclosed are
indexing methods and devices that facilitate treatment of
successive portions of the hollow anatomical structure.
[0008] One embodiment comprises a catheter for use in treating a
hollow anatomical structure. The catheter comprises an elongated
shaft having a distal end and a proximal end; and an energy
application device located proximate the distal end of the shaft.
The energy application device has a first length. The catheter
further comprises a plurality of index markers located along the
shaft and proximal of the energy application device such that
consecutive index markers are spaced apart by a second length. The
second length comprises an indexing distance of the energy
application device.
[0009] In one variation of the catheter, the second length is
approximately equal to or slightly shorter than the first length.
In a further variation, the first length is between approximately 2
centimeters and approximately 10 centimeters and the second length
is between approximately 0.1 centimeter and approximately 1.5
centimeters less than the first length. In another further
variation, the first length is approximately 7 centimeters and the
second length is approximately 6.5 centimeters.
[0010] In some variations of the catheter, the shaft further
comprises a stop-treatment marker or a last-treatment marker
located proximal of the energy application device and distal of the
plurality of index markers. In a further variation, the
stop-treatment marker can include a plurality of warning markers
corresponding to a plurality of introducer lengths.
[0011] In some variations of the catheter, the plurality of index
markers can comprise any of the following: alphanumeric markers,
color-coded markers, geometrically coded markers, at least one
magnetic ink marker readable by an external sensor, or at least one
detent in the shaft.
[0012] In one variation of the catheter, at least a portion of the
catheter is sterile. In a further variation, a method can comprise
sterilizing the catheter.
[0013] In some variations of the catheter, the energy application
device can have an adjustable active length, and/or an active
region which is adjustable in size. In a further variation, the
energy application device comprises a heater element with a
plurality of separately operable heater sections which are arranged
longitudinally along the first length.
[0014] Another embodiment comprises a method for treating a hollow
anatomical structure. The method comprises inserting a catheter
having an energy application device having a first length and
indexing marks on the catheter shaft proximal to the energy
application device through an introducer sheath in a hollow
anatomical structure of a patient. The method further comprises
positioning the energy application device at a first treatment
location in the hollow anatomical structure. The method further
comprises, while the energy application device is at the first
treatment location of the hollow anatomical structure, withdrawing
the sheath or adjusting a reference point of the sheath until the
reference point of the sheath is aligned with one of the indexing
marks on the catheter shaft. The method further comprises applying
energy with the energy application device to the first treatment
location in the hollow anatomical structure; and positioning the
catheter at one or more subsequent treatment locations in the
hollow anatomical structure by moving the catheter shaft through
the sheath until another one or more of the indexing marks is
aligned with the reference point of the sheath. The method further
comprises applying energy with the energy application device to
each subsequent treatment location.
[0015] In some variations of the method, the reference point of the
sheath comprises the proximal end of the sheath, or an adjustable
reference marker.
[0016] In one variation, the method further comprises securing the
sheath with respect to the hollow anatomical structure before
moving the catheter to one or more subsequent treatment locations.
Securing the sheath can optionally comprise securing the sheath to
the patient.
[0017] Another embodiment comprises a method for treating a hollow
anatomical structure. The method comprises inserting a catheter
into a hollow anatomical structure of a patient. The catheter has
an energy application device with a first length. The method
further comprises applying energy, with the energy application
device, to a first treatment location of the hollow anatomical
structure. The method further comprises moving the catheter
proximally to one or more additional treatment locations of the
hollow anatomical structure, wherein each additional treatment
location is offset by an indexing length from the preceding
treatment location. The method further comprises applying energy,
with the energy application device, to the one or more additional
treatment locations of the hollow anatomical structure.
[0018] In one variation of the method, the indexing length is
approximately equal to or slightly shorter than the first
length.
[0019] In another variation of the method, moving the catheter
proximally comprises aligning an index marking on the catheter with
a reference point. The reference point can optionally be on an
introducer through which the catheter is inserted.
[0020] Another variation of the method further comprises monitoring
a temperature within the hollow anatomical structure.
[0021] In some variations of the method, applying energy to the
first location can comprise applying energy to the first location
at two distinct times, or applying energy to the first location for
a longer duration than to any one of the additional locations.
Where energy is applied to the first location for a longer
duration, the hollow anatomical structure can optionally have a
larger cross-sectional profile, as viewed along a longitudinal axis
of the hollow anatomical structure, in the first location than in
any of the additional locations. Where energy is applied to the
first location for a longer duration, the hollow anatomical
structure can comprise the great saphenous vein, and the first
location can be closer to the sapheno-femoral junction than is any
of the additional locations.
[0022] Another embodiment comprises an apparatus. The apparatus
comprises a catheter shaft extending from a proximal end to a
distal end; an energy application device proximate the distal end
of the catheter shaft; and markers along the length of the catheter
shaft. The markers are spaced apart at a multiple of the length of
the energy application device.
[0023] In one variation of the apparatus, the length of the energy
application device is between approximately 2 centimeters and
approximately 10 centimeters.
[0024] In another variation of the apparatus, the energy
application device is a resistive heating device. Such an energy
application device can optionally be a wound nichrome wire.
[0025] In another variation of the apparatus, the energy
application device comprises a Resistance Temperature Detector
(RTD) configured to sense the temperature of the energy application
device by a measurement of the impedance of the energy application
device.
[0026] In another variation of the apparatus, the energy
application device comprises one or more radio frequency (RF)
electrodes.
[0027] In another variation of the apparatus, the markers are
spaced apart at a fraction of the length of the energy application
device.
[0028] In another variation of the apparatus, at least a portion of
the apparatus is sterile. A method can comprise sterilizing the
apparatus.
[0029] Another variation of the apparatus further comprises at
least one temperature sensor.
[0030] In another variation of the apparatus, the energy
application device has an adjustable active length.
[0031] In another variation of the apparatus, the energy
application device has an active region which is adjustable in
size. Such an energy application device can optionally comprise a
heater element with a plurality of separately operable heater
sections which are arranged longitudinally.
[0032] Another embodiment comprises a method for treating a hollow
anatomical structure. The method comprises inserting a catheter
having a heating element coupled thereto, into a hollow anatomical
structure; energizing the heating element at a first treatment
position within the hollow anatomical structure; moving the
catheter an indexed distance in a proximal direction to an
additional treatment position within the hollow anatomical
structure; and energizing the heating element at the additional
treatment position.
[0033] In one variation of the method, the method further comprises
repeating (a) moving the catheter an indexed distance to an
additional treatment position, and (b) energizing the heating
element at the additional treatment position, until a desired
length of the hollow anatomical structure is treated.
[0034] In another variation of the method, the hollow anatomical
structure comprises a human vein.
[0035] Another variation of the method further comprises
determining the indexed distance with a plurality of markings along
a shaft of the catheter.
[0036] In another variation of the method, moving the catheter the
indexed distance comprises securing a proximal end of an indexing
device to a shaft of the catheter; and extending the proximal end
of the indexing device the indexed distance from a distal end of
the indexing device, thereby moving the catheter shaft by the
indexed distance from the distal end of the indexing device.
[0037] In another variation of the method, at least one of the
additional treatment locations slightly overlaps the preceding
treatment location.
[0038] In another variation of the method, energizing the heating
element at the first treatment position comprises energizing the
heating element at two distinct times.
[0039] In another variation of the method, energizing the heating
element at the first treatment position comprises energizing the
heating element for a longer duration than at any one of the
additional treatment positions. In this variation, the hollow
anatomical structure can optionally have a larger cross-sectional
profile, as viewed along a longitudinal axis of the hollow
anatomical structure, in the first treatment position than in any
of the additional treatment positions. In this variation, the
hollow anatomical structure can further optionally comprise the
great saphenous vein, and the first treatment position can be
closer to the sapheno-femoral junction than is any of the
additional treatment positions.
[0040] Another embodiment comprises a catheter for treating a
hollow anatomical structure. The catheter comprises an elongate
shaft; means for applying energy to a hollow anatomical structure.
The means for applying energy is secured to the shaft and has a
first length. The catheter further comprises a plurality of means
for indexing located along the shaft and proximal of the means for
applying energy. Each of the plurality of means for indexing is
spaced apart by a second length.
[0041] In one variation of the catheter, the second length is
approximately equal to or slightly less than the first length.
[0042] In another variation of the catheter, the means for applying
energy comprises a resistive heating device.
[0043] Another embodiment comprises a catheter for use in treating
a hollow anatomical structure. The catheter comprises an elongated
shaft having a distal end and a proximal end; and an energy
application device coupled to the shaft. The energy application
device has a first length. The catheter further comprises a
plurality of index markers located along the shaft and proximal of
the energy application device such that consecutive index markers
are spaced apart by a second length. The second length is equal to
the first length less a decrement. The decrement is between 1% and
15% of the first length.
[0044] In one variation of the catheter, the first length is
between 2 and 10 centimeters, and the decrement is between 0.1 and
1.5 centimeters.
[0045] In another variation of the catheter, the first length is
approximately 7 centimeters and the second length is approximately
6.5 centimeters.
[0046] In another variation of the catheter, the shaft further
comprises a stop-treatment marker located distal of the plurality
of index markers, and the stop-treatment marker is distinct from
the index markers.
[0047] In another variation of the catheter, the energy application
device comprises an electrically driven heater element.
[0048] In another variation of the catheter, the energy application
device has an energy coupling surface which extends along the first
length. In such a variation, the first length can be at least ten
times a width of the energy application device.
[0049] In another variation of the catheter, the energy application
device is configured to generate heat internally and transfer heat
radially outwardly away from a central longitudinal axis of the
energy application device.
[0050] Another embodiment comprises an introducer sheath. The
introducer sheath comprises a sheath lumen having a distal end
which is insertable into a hollow anatomical structure. The sheath
lumen extends generally along a luminal axis in a
distal-to-proximal direction. The introducer sheath further
comprises an adjustable reference marker connected to the sheath.
The longitudinal position, as measured along the luminal axis, of
the reference marker is adjustable.
[0051] In one variation of the introducer sheath, the adjustable
reference marker includes a flexible elongate member of variable
length that is attached to the proximal end of the sheath.
[0052] In another variation of the introducer sheath, the
adjustable reference marker is removably connected to the
sheath.
[0053] Another embodiment comprises a hollow anatomical structure
treatment system, which comprises the introducer sheath, and a
catheter shaft disposed in the sheath lumen. The catheter shaft
extends proximally past the reference marker, and has a plurality
of indexing marks. The reference marker is longitudinally
adjustable relative to the catheter shaft to permit alignment of
the reference marker with one of the indexing marks without need
for movement of the shaft relative to the sheath.
[0054] Another embodiment comprises a method of facilitating the
treatment of a hollow anatomical structure. The method comprises
initiating power delivery to an energy application device of a
hollow anatomical structure treatment device; and measuring an
operating parameter of the treatment device. The operating
parameter is relevant to energy coupling between the energy
application device and its surroundings. The method further
comprises determining whether the operating parameter satisfies a
first energy coupling condition within a first time interval
following the initiating; and, if the operating parameter does not
satisfy the first energy coupling condition within the first time
interval, providing a warning.
[0055] In one variation of the method, the operating parameter is a
measure of the temperature of at least a portion of the treatment
device. In such a variation, the operating parameter can optionally
be a measure of the temperature of at least a portion of the energy
application device.
[0056] In another variation of the method, the operating parameter
is a measure of the power delivered to the energy application
device.
[0057] In another variation of the method, the power delivery is
provided via an electric current in the energy application device.
In such a variation, the operating parameter can optionally be one
of the following: a measure of the electrical power delivered to
the energy application device; a measure of the electric current;
and/or a measure of the electrical impedance of the energy
application device. In such a variation, the energy application
device can optionally comprise a conducting coil.
[0058] In another variation of the method, the operating parameter
is a measure of the temperature of at least a portion of the energy
application device, and the first energy coupling condition
comprises meeting or exceeding a first target temperature value for
the temperature of at least a portion of the energy application
device. In such a variation, the first energy coupling condition
can optionally comprise meeting or exceeding the first target
temperature value within a prescribed period of time after
initiating power delivery.
[0059] In another variation of the method, the operating parameter
is a measure of the temperature of at least a portion of the energy
application device, and the first energy coupling condition
comprises absence of sudden changes to the temperature of at least
a portion of the energy application device.
[0060] In another variation of the method, the operating parameter
is a measure of the power delivered to the energy application
device, and the first energy coupling condition comprises a
delivered power magnitude which is substantially similar to a
reference waveform of expected power magnitude.
[0061] In another variation of the method, the operating parameter
is a measure of the power delivered to the energy application
device, and the first energy coupling condition comprises a rate of
change of the magnitude of power delivered to the energy
application device which is substantially similar to a reference
waveform of expected power delivered after achievement of a target
temperature value.
[0062] In another variation of the method, the power delivery is
provided via an electric current in the energy application device,
the operating parameter is a measure of the electric current, and
the first energy coupling condition comprises a delivered electric
current magnitude which is substantially similar to a reference
waveform of expected electric current magnitude.
[0063] In another variation of the method, the power delivery is
provided via an electric current in the energy application device,
the operating parameter is a measure of the electric current, and
the first energy coupling condition comprises a rate of change of
the magnitude of electric current delivered to the energy
application device which is substantially similar to a reference
waveform of expected electric current delivered after achievement
of a target temperature value.
[0064] In another variation of the method, the power delivery is
provided via an electric current in the energy application device,
the operating parameter is a measure of the electrical impedance of
the energy application device, and the first energy coupling
condition comprises a measured electrical impedance magnitude which
is substantially similar to a reference waveform of expected
electrical impedance of the energy application device.
[0065] In another variation of the method, the power delivery is
provided via an electric current in the energy application device,
the operating parameter is a measure of the electrical impedance of
the energy application device, and the first energy coupling
condition comprises a measured rate of change of the magnitude of
the electrical impedance of the energy application device which is
substantially similar to a reference waveform of expected
electrical impedance of the energy application device.
[0066] Another variation of the method further comprises
terminating or reducing power delivery to the energy application
device if the operating parameter does not satisfy the first energy
coupling condition within the first time interval.
[0067] In another variation of the method, the warning comprises a
message to adjust the environment of the hollow anatomical
structure treatment device within a patient. In such a variation,
the message instructs a user to adjust or improve compression of
the portion of the hollow anatomical structure containing the
treatment device.
[0068] Another variation of the method further comprises
determining whether the operating parameter satisfies a second
energy coupling condition within a second time interval following
the first time interval; and, if the operating parameter does not
satisfy the second energy coupling condition within the second time
interval, providing a warning. In such a variation, the method can
optionally further comprise terminating or reducing power delivery
to the energy application device if the operating parameter does
not satisfy the second energy coupling condition within the second
time interval.
[0069] Another embodiment comprises a method of facilitating the
treatment of a hollow anatomical structure. The method comprises
initiating power delivery to an energy application device of a
hollow anatomical structure treatment device; measuring two
operating parameters of the treatment device, the operating
parameters being relevant to energy coupling between the energy
application device and its surroundings; determining whether the
operating parameters satisfy a first energy coupling condition
within a first time interval following the initiating; and, if the
operating parameters do not satisfy the first energy coupling
condition within the first time interval, providing a warning.
[0070] In some variations of the method, the operating parameters
are the temperature of at least a portion of the energy application
device and the electrical impedance of the energy application
device. In such a variation, the energy application device can
optionally comprise a resistance temperature device; and the method
can further optionally comprise computing a temperature of the
energy application device based on the electrical impedance of the
energy application device, and the first energy coupling condition
can further optionally comprise correlation of the measured
temperature of the energy application device to the computed
temperature of the energy application device.
[0071] Another embodiment comprises an apparatus for use in
treating a hollow anatomical structure. The apparatus comprises an
energy application device adapted to receive power from a power
source, and a measuring device that measures an operating parameter
of the energy application device. The operating parameter is
relevant to energy coupling between the energy application device
and its surroundings. The apparatus further comprises a module in
communication with the measuring device. The module is configured
to determine whether the operating parameter satisfies a first
energy coupling condition within a first time interval following
the initiation of power delivery to the energy application device.
The apparatus further comprises a warning device in communication
with the module. The module is further configured to cause the
warning device to provide a warning if the operating parameter does
not satisfy the first energy coupling condition within the first
time interval.
[0072] In one variation of the apparatus, the operating parameter
is a measure of the temperature of at least a portion of the energy
application device.
[0073] In another variation of the apparatus, the operating
parameter is a measure of the power delivered to the energy
application device.
[0074] In another variation of the apparatus, the energy
application device is adapted to receive power via an electric
current. In such a variation, the operating parameter can
optionally be any of the following: a measure of the electrical
power delivered to the energy application device; a measure of the
electric current; and/or a measure of the electrical impedance of
the energy application device.
[0075] In another variation of the apparatus, the energy
application device comprises a conducting coil.
[0076] In another variation of the apparatus, the operating
parameter is a measure of the temperature of at least a portion of
the energy application device, and the first energy coupling
condition comprises meeting or exceeding a first target temperature
value for the temperature of at least a portion of the energy
application device. In such a variation, the first energy coupling
condition can optionally comprise meeting or exceeding the first
target temperature value within a prescribed period of time after
initiating power delivery.
[0077] In another variation of the apparatus, the operating
parameter is a measure of the temperature of at least a portion of
the energy application device, and the first energy coupling
condition comprises absence of sudden changes to the temperature of
at least a portion of the energy application device.
[0078] In another variation of the apparatus, the energy
application device is adapted to receive power via an electric
current, and the first energy coupling condition comprises a
delivered power magnitude which is substantially similar to a
reference waveform of expected power magnitude.
[0079] In another variation of the apparatus, the energy
application device is adapted to receive power via an electric
current, and the first energy coupling condition comprises a rate
of change of the magnitude of power delivered to the energy
application device which is substantially similar to a reference
waveform of expected power delivered after achievement of a target
temperature value.
[0080] In another variation of the apparatus, the energy
application device is adapted to receive power via an electric
current, the operating parameter is a measure of the electric
current, and the first energy coupling condition comprises a
delivered electric current magnitude which is substantially similar
to a reference waveform of expected electric current magnitude.
[0081] In another variation of the apparatus, the energy
application device is adapted to receive power via an electric
current, the operating parameter is a measure of the electric
current, and the first energy coupling condition comprises a rate
of change of the magnitude of electric current delivered to the
energy application device which is substantially similar to a
reference waveform of expected electric current delivered after
achievement of a target temperature value.
[0082] In another variation of the apparatus, the energy
application device is adapted to receive power via an electric
current, the operating parameter is a measure of the electrical
impedance of said energy application device, and the first energy
coupling condition comprises a measured electrical impedance
magnitude which is substantially similar to a reference waveform of
expected electrical impedance of the energy application device.
[0083] In another variation of the apparatus, the energy
application device is adapted to receive power via an electric
current, the operating parameter is a measure of the electrical
impedance of said energy application device, and the first energy
coupling condition comprises a measured rate of change of the
magnitude of the electrical impedance of the energy application
device which is substantially similar to a reference waveform of
expected electrical impedance of the energy application device.
[0084] In another variation of the apparatus, the module is further
configured to terminate or reduce power delivery to the energy
application device if the operating parameter does not satisfy the
first energy coupling condition within the first time interval.
[0085] In another variation of the apparatus, the module is further
configured to cause the warning device to provide a message to a
user of the apparatus to adjust the environment of the hollow
anatomical structure treatment device within a patient. In such a
variation, the message can optionally instruct a user to adjust or
improve compression of the portion of the hollow anatomical
structure containing the treatment device.
[0086] In another variation of the apparatus, the module is further
configured to determine whether the operating parameter satisfies a
second energy coupling condition within a second time interval
following the first time interval, and to provide a warning if the
operating parameter does not satisfy the second energy coupling
condition within the second time interval. In such a variation, the
module can optionally be further configured to terminate or reduce
power delivery to the energy application device if the operating
parameter does not satisfy the second energy coupling condition
within the second time interval.
[0087] Another embodiment comprises a method of avoiding
interference with heat treatment of a hollow anatomical structure
within a patient. The method comprises initiating power delivery to
an energy application device of a hollow anatomical structure
treatment device. The energy application device is disposed within
a hollow anatomical structure. The method further comprises
measuring an operating parameter of the treatment device. The
operating parameter is relevant to energy coupling between the
energy application device and its surroundings. The method further
comprises determining whether the operating parameter satisfies a
first energy coupling condition within a first time interval
following the initiating. The method further comprises taking
corrective measures to improve the energy coupling between the
energy application device and its surroundings, if the operating
parameter does not satisfy the first energy coupling condition
within the first time interval.
[0088] In some variations of this method, the operating parameter
can be any one or more of the following: a measure of the
temperature of at least a portion of the energy application device;
a measure of the power delivered to the energy application device;
and/or a measure of electrical impedance within a current path
associated with the delivery of power to the energy application
device.
[0089] In some variations of this method, the corrective measures
can comprise any one or more of the following: applying compression
in the vicinity of the hollow anatomical structure containing the
energy application device; adjusting the location or force of
existing compression in the vicinity of the hollow anatomical
structure containing the energy application device; and/or
verifying effective occlusion of flow within the hollow anatomical
structure in the vicinity of the energy application device.
[0090] Another embodiment comprises a method. The method comprises
sensing a temperature on or near at least a portion of a heat
application device of a hollow anatomical structure treatment
device; determining whether the temperature satisfies a required
initial temperature condition; receiving a request to initiate
power delivery to the heat application device of the hollow
anatomical structure treatment device; and performing a safety
procedure to interrupt a normal power-up process for the heat
application device, if the temperature does not satisfy the
required initial temperature condition.
[0091] In one variation of the method, the method further comprises
allowing a normal power-up process for the heat application device
to proceed if the temperature satisfies the required initial
temperature condition.
[0092] In another variation of the method, determining whether the
temperature satisfies a required initial temperature condition,
comprises determining whether the temperature has satisfied the
required initial temperature condition at any time during a
temperature sensing period. In such a variation, the temperature
sensing period can optionally begin after connection of the
treatment device to a power source. In such a variation, the
temperature sensing period can further optionally end before
delivery of therapeutic energy from the power source to the
treatment device.
[0093] In another variation of the method, the safety procedure
comprises preventing the initiation of power delivery to the heat
application device.
[0094] In another variation of the method, the safety procedure
comprises ceasing the delivery of power to the heat application
device.
[0095] In another variation of the method, the required initial
temperature condition comprises that the temperature meet or exceed
a minimum temperature. In such a variation, the minimum temperature
can optionally be any one or more of the following: significantly
above an expected ambient room temperature; substantially at an
expected internal temperature of the hollow anatomical structure to
be treated with the treatment device; and/or 5 to 10 degrees
Celsius lower than the normal physiologic internal temperature of a
hollow anatomical structure of the type normally treated with the
treatment device.
[0096] In another variation of the method, the required initial
temperature condition comprises that the temperature fall within an
acceptable temperature range. In such a variation, the acceptable
temperature range can optionally be any one or more of the
following: significantly above an expected ambient room
temperature; bracketing an expected internal temperature of the
hollow anatomical structure to be treated with the treatment
device; and/or bracketing a temperature which is 5 to 10 degrees
Celsius lower than the normal physiologic internal temperature of a
hollow anatomical structure of the type normally treated with the
treatment device.
[0097] Another variation of the method further comprises providing
a warning if the temperature does not satisfy the required initial
temperature condition.
[0098] Another variation of the method further comprises (a)
verifying that the heat application device is properly disposed
within a hollow anatomical structure of a patient; and (b) manually
overriding the safety procedure and initiating a power-up process
for the heat application device, if the temperature does not
satisfy the required initial temperature condition.
[0099] Another embodiment comprises an apparatus for use in
treating a hollow anatomical structure. The apparatus comprises a
heat application device adapted to receive power from a power
source; a user interface adapted to receive a request from a user
to initiate power delivery to the heat application device; a
temperature measuring device for measuring a temperature within or
near the heat application device; and a module in communication
with the temperature measuring device and the user interface. The
module is configured to determine whether a temperature measured by
the temperature measuring device satisfies a required initial
temperature condition. The module is further configured to follow a
safety procedure to interrupt a normal power-up process for the
heat application device if the temperature measured by the
temperature measuring device does not satisfy the required initial
temperature condition.
[0100] In one variation of the apparatus, the module is further
configured to follow a normal power-up process for the heat
application device if the temperature measured by the temperature
measuring device satisfies the required initial temperature
condition.
[0101] In another variation of the apparatus, the module is further
configured to determine whether the temperature has satisfied the
required initial temperature condition at any time during a
temperature sensing period.
[0102] In another variation of the apparatus, the safety procedure
comprises preventing the initiation of power delivery to the heat
application device.
[0103] In another variation of the apparatus, the safety procedure
comprises ceasing the delivery of power to the heat application
device.
[0104] In another variation of the apparatus, the required initial
temperature condition comprises that the temperature meet or exceed
a minimum temperature.
[0105] In another variation of the apparatus, the minimum
temperature is above an expected ambient room temperature
[0106] In another variation of the apparatus, the minimum
temperature is substantially at an expected internal temperature of
the hollow anatomical structure to be treated with the treatment
device.
[0107] In another variation of the apparatus, the minimum
temperature is 5 to 10 degrees Celsius lower than the normal
physiologic internal temperature of a hollow anatomical structure
of the type normally treated with the treatment device.
[0108] In another variation of the apparatus, the required initial
temperature condition comprises that the temperature fall within an
acceptable temperature range. In such a variation, the acceptable
temperature range can optionally be any one or more of the
following: significantly above an expected ambient room
temperature; bracketing an expected internal temperature of the
hollow anatomical structure to be treated with the treatment
device; and/or bracketing a temperature which is 5 to 10 degrees
Celsius lower than the normal physiologic internal temperature of a
hollow anatomical structure of the type normally treated with the
treatment device.
[0109] Another variation of the apparatus further comprises a
warning device in communication with the module, wherein the module
is further configured to cause the warning device to provide a
warning if the temperature does not satisfy the required initial
temperature condition.
[0110] In another variation of the apparatus, the user interface is
further adapted to receive a request from a user to manually
override the safety procedure; and the module is further configured
to initiate a power-up process for the heat application device upon
receiving a user request to manually override the safety
procedure.
[0111] In certain embodiments, a hollow anatomical structure
therapy system is disclosed which comprises: an energy application
device suitable for insertion into a hollow anatomical structure; a
power source in communication with the energy application device,
the power source comprising a processor and program instructions
executable by the processor such that the power source is operable
to: (a) deliver power to the energy application device during a
first power delivery phase; (b) measure time elapsing during power
delivery; (c) assess performance of the therapy system during the
first power delivery phase; and (d) if the performance of the
therapy system during the first power delivery phase is
satisfactory, deliver power to the energy application device during
a second power delivery phase.
[0112] In a further variation, the energy application device is
selected from the group consisting of an electrically driven
heating element, an electrode, and a laser.
[0113] In further variations, the energy application device
comprises an electrically driven heating element with an energy
coupling surface, the surface having a distal-to-proximal length
which is at least fifteen times a width of the heating element.
[0114] In further variations, the system further comprises a
catheter having a shaft to which the energy application device is
coupled.
[0115] In other variations, the system further comprises a
temperature sensor configured to sense at least one of (i) a
temperature of at least a portion of the energy application device,
and (ii) a temperature of tissue in thermal communication with the
energy application device.
[0116] In a further variation of the system, the program
instructions are executable by the processor such that the power
source is further operable to: deliver power to the energy
application device to reach a first treatment temperature; and
deliver power to the energy application device to reach a
subsequent second treatment temperature which is lower than the
first treatment temperature.
[0117] In a further variation of the system, the program
instructions are executable by the processor such that the power
source is further operable to determine expiration of the first
power delivery phase based on temperature measurement results
obtained by the temperature sensor.
[0118] In a further variation of the system, the first power
delivery phase is 10 seconds or less in duration.
[0119] In a further variation of the system, satisfactory
performance of the therapy system comprises reaching or exceeding a
target temperature within a time limit. In a further variation of
the system, the program instructions are executable by the
processor such that the power source proceeds to the second power
delivery phase only when the temperature sensor senses the target
temperature within the time limit. In a further variation of the
system, the program instructions are executable by the processor
such that the power source is further operable to determine
expiration of the first power delivery phase when the temperature
sensor senses a target temperature within a time limit. In a
further variation of the system, the time limit is six seconds or
less.
[0120] In a further variation of the system, the target temperature
is approximately 120 degrees Celsius.
[0121] In a further variation of the system, the combined duration
of the first power delivery phase and the second power delivery
phase is 60 seconds or less.
[0122] In certain embodiments, a hollow anatomical structure
therapy system is disclosed which comprises: a heat delivery device
suitable for insertion into a hollow anatomical structure; a power
source in communication with the heat delivery device, the power
source being programmed to: (a) deliver power to the heat delivery
device during a temperature ramp-up phase; (b)measure time elapsing
during power delivery; (c) monitor operation of the heat delivery
device; and (d)if the operation of the heat delivery device either
during or shortly after the temperature ramp-up phase is
acceptable, deliver power to the heat delivery device after the
temperature ramp-up phase.
[0123] In a further variation of the system, the heat delivery
device is selected from the group consisting of an electrically
driven heating element, an electrode, and a laser. In a further
variation of the system, the heat delivery device comprises an
electrically driven heating element with an energy coupling
surface, the surface having a distal-to-proximal length which is at
least fifteen times a width of the heating element.
[0124] Another variation of the system further comprises a catheter
having a shaft to which the heat delivery device is coupled.
[0125] Another variation of the system further comprises a
temperature sensor configured to sense at least one of (i) a
temperature of a portion of the heat delivery device, and (ii) a
temperature of tissue in thermal communication with the heat
delivery device.
[0126] In a further variation of the system, acceptable operation
of the heat delivery device during or shortly after the temperature
ramp-up phase comprises reaching or exceeding a target temperature
within a time limit. In a further variation of the system,
acceptable operation of the heat delivery device during or shortly
after the temperature ramp-up phase comprises falling below a
target temperature within a time limit. In a further variation of
the system, the combined duration of the temperature ramp-up phase
and a subsequent power delivery phase is 60 seconds or less.
[0127] In a further variation of the system, the power source is
further programmed to: deliver power to the heat delivery device to
reach a first treatment temperature; and deliver power to the heat
delivery device to reach a subsequent second treatment temperature
which is lower than the first treatment temperature.
[0128] In certain embodiments, a method of treating a hollow
anatomical structure is disclosed, the method comprising: inserting
a heat delivery device into a hollow anatomical structure;
delivering power to the heat delivery device during a temperature
ramp-up phase; measuring time elapsing during power delivery;
monitoring operation of the heat delivery device; and if the
operation of the heat delivery device during or shortly after the
temperature ramp-up phase is acceptable, delivering power to the
heat delivery device after the temperature ramp-up phase.
[0129] In a further variation, the method additionally comprises:
delivering power to the heat delivery device to reach a first
treatment temperature; and delivering power to the heat delivery
device to reach a subsequent second treatment temperature which is
lower than the first treatment temperature.
[0130] In a further variation of the method, the heat delivery
device is selected from the group consisting of an electrically
driven heating element, an electrode, and a laser. In a further
variation of the method, the heat delivery device comprises an
electrically driven heating element with an energy coupling
surface, the surface having a distal-to-proximal length which is at
least fifteen times a width of the heating element.
[0131] In a further variation, the method additionally comprises
measuring a temperature of at least one of (i) at least a portion
of the heat delivery device, and (ii) a portion of the hollow
anatomical structure being treated.
[0132] In a further variation of the method, monitoring operation
of the heat delivery device comprises determining whether the
measured temperature reaches or exceeds a target temperature within
a time limit. In a further variation of the method, operation of
the heat delivery device comprises determining whether the measured
temperature falls below a target temperature within a time limit.
In a further variation, the method additionally comprises
proceeding to deliver power to the heat delivery device after the
temperature ramp-up phase only when the target temperature is
reached or exceeded within the time limit. In a further variation,
the method additionally comprises proceeding to deliver power to
the heat delivery device after the temperature ramp-up phase only
when the target temperature falls below a target temperature within
a time limit.
[0133] In a further variation of the method, monitoring operation
of the heat delivery device comprises comparing a measurement of
electrical impedance with a reference waveform.
[0134] In a further variation, the method additionally comprises
displaying an instruction to adjust treatment of the hollow
anatomical structure if the operation of the heat delivery device
during the temperature ramp-up phase is not acceptable.
[0135] In a further variation of the method, displaying an
instruction to adjust treatment of the hollow anatomical structure
comprises displaying an instruction to adjust compression of the
hollow anatomical structure.
[0136] In a further variation of the method, the hollow anatomical
structure comprises a vein.
[0137] In certain embodiments, a method is disclosed for treatment
of hollow anatomical structures that comprises: inserting an
electrically driven heating element into the hollow anatomical
structure, the heating element extending distally along a
longitudinal axis of the element, the heating element having a
length and a width measured orthogonal to the longitudinal axis,
the length being greater than the width; powering the heating
element and thereby causing the heating element to reach or exceed
a minimal treatment temperature; moving the heating element within
the hollow anatomical structure along a lengthwise direction of the
hollow anatomical structure, and maintaining the heating element at
or above the minimal treatment temperature while moving the heating
element along the lengthwise direction. In a further variation, the
movement of the heating element may be initiated after an initial
delay after the minimal treatment temperature is reached.
[0138] In further variations of the method, the moving comprises
moving the heating element without stopping along a treatment
length of the hollow anatomical structure, and the treatment length
is greater than the heating element length. In other variations of
the method, the movement of the heating element may be temporarily
stopped or slowed when the temperature of the heating element
deviates from a target treatment temperature by more than 3 degrees
Celsius.
[0139] In further variations of the method, the minimal treatment
temperature may be an internal temperature of the heating element,
or may be a temperature measured at or adjacent tot the heating
element. In further variations of the method, the minimal treatment
temperature is sufficient to cause durable reduction of the
diameter of the hollow anatomical structure. In further variations
of the method, the minimal treatment temperature is sufficient to
cause absence of patency of the hollow anatomical structure. In
further variations of the method, the minimal treatment temperature
may be within a range of 80-140 degrees Celsius, and may be
approximately 120 degrees Celsius or approximately 95 degrees
Celsius.
[0140] In another variation of the method, the heating element is
coupled to a shaft of a catheter. In a further variation of the
method, heated fluid is delivered from a tip of the catheter while
moving the heating element. In other variations of the method, the
fluid may be passed through a lumen of the catheter, heating the
fluid with the heating element as the fluid passes through the
lumen before exiting the catheter tip.
[0141] In a variation of the method, the length of the heating
element is at least equal to fifteen times its width. In a further
variation of the method, the heating element extends to the distal
end of the catheter. In a further variation of the method, the
heating element may be a coil having a variable pitch.
[0142] In a further variation of the method, laser light is applied
to the hollow anatomical structure with the catheter.
[0143] In another embodiment, a method is disclosed for treatment
of hollow anatomical structures that comprises: inserting an
electrically driven heating element into the hollow anatomical
structure, the heating element extending distally along a
longitudinal axis of the element, the heating element having a
length and a width measured orthogonal to the longitudinal axis,
the length being greater than the width; moving the heating element
within the hollow anatomical structure along a lengthwise direction
of the hollow anatomical structure while applying electrical power
to the heating element within a treatment power level range, and
applying power to the heating element within the treatment power
level range while moving the heating element along the lengthwise
direction.
[0144] In a variation of the method, the moving comprises moving
the heating element without stopping along a treatment length of
the hollow anatomical structure, the treatment length being greater
than the heating element length.
[0145] In a variation of the method, the treatment power level
range is 20-40W.
[0146] In a variation of the method, the heating element is coupled
to a shaft of a catheter.
[0147] A variation of the method further comprises delivering
heated fluid from a tip of the catheter while moving the heating
element. Another variation of the method further comprises passing
the fluid through a lumen of the catheter and heating the fluid
with the heating element as the fluid passes through the lumen
before the fluid exits the catheter tip.
[0148] In a variation of the method, the length of the heating
element is at least equal to fifteen times the width thereof. In
another variation of the method, the heating element is a coil
having a variable pitch. In another variation of the method, the
heating element extends to a distal end of the catheter.
[0149] A variation of the method further comprises applying laser
light to the hollow anatomical structure with the catheter.
[0150] In another embodiment, methods are disclosed for treatment
of hollow anatomical structures comprising: inserting an
electrically driven heating element into the hollow anatomical
structure, the heating element extending distally along a
longitudinal axis of the element, the heating element having a
fixed profile in a plane orthogonal to a longitudinal axis thereof;
powering the heating element and thereby causing the heating
element to reach or exceed a minimal treatment temperature; moving
the heating element within the hollow anatomical structure along a
lengthwise direction of the hollow anatomical structure, and
maintaining the heating element at or above the minimal treatment
temperature while moving the heating element along the lengthwise
direction.
[0151] In a variation of the method, the moving comprises moving
the heating element without stopping along a treatment length of
the hollow anatomical structure, the treatment length being greater
than a length of the heating element.
[0152] In a variation of the method, the minimal treatment
temperature is sufficient to cause durable reduction of the
diameter of the hollow anatomical structure. In another variation
of the method, the minimal treatment temperature is sufficient to
cause absence of patency of the hollow anatomical structure.
[0153] In a variation of the method, the heating element is coupled
to a shaft of a catheter.
[0154] A variation of the method further comprises delivering
heated fluid from a tip of the catheter while moving the heating
element. Another variation of the method further comprises passing
the fluid through a lumen of the catheter and heating the fluid
with the heating element as the fluid passes through the lumen
before the fluid exits the catheter tip.
[0155] A variation of the method further comprises applying laser
light to the hollow anatomical structure with the catheter.
[0156] In one embodiment, an apparatus for treating a hollow
anatomical structure is disclosed that comprises: an elongate
shaft; a therapeutic energy application device coupled to the
shaft, the energy application device being sized for insertion into
a hollow anatomical structure; and at least one
visibility-enhancing element near the energy application
device.
[0157] In a variation of the apparatus, the therapeutic energy
application device is coupled to the shaft near a distal end of the
shaft.
[0158] In another variation of the apparatus, the
visibility-enhancing element is a light emitter. In a further
variation, the light emitter is a visible light emitter. In a
further variation, the light emitter is configured to direct light
radially outward, away from a longitudinal axis of the shaft. In a
further variation, a plurality of the light emitters are spaced
radially apart around the longitudinal axis. In a further
variation, the light emitter comprises an optical fiber connected
to a light generator.
[0159] In another variation of the apparatus, the
visibility-enhancing element is an ultrasound emitter. In a further
variation, the visibility-enhancing element is a portion of the
apparatus that is relatively highly reflective of ultrasound. In a
further variation, the visibility-enhancing element comprises at
least one gas bubble delivery port. In a further variation, the
visibility-enhancing element is a portion of an outer surface of
the shaft, which portion is configured to trap one or more gas
bubbles.
[0160] In another variation of the apparatus, the
visibility-enhancing element is a portion of the apparatus that is
relatively highly radiopaque.
[0161] In another variation of the apparatus, the energy
application device has a length greater than the width thereof.
[0162] In another variation of the apparatus, the energy
application device is an electrically driven heater element. In a
further variation, the electrically driven heater element is a
closed circuit heating element.
[0163] In another variation of the apparatus, the
visibility-enhancing element is configured to facilitate viewing a
position of the energy application device within the hollow
anatomical structure.
[0164] In another variation of the apparatus, at least one
visibility-enhancing element comprises one visibility-enhancing
element next to a proximal end of the energy application device,
and another visibility-enhancing element next to a distal end
thereof.
[0165] In another variation of the apparatus, the elongate shaft
includes a plurality of longitudinally spaced index markings. In a
further variation, the index markings are spaced apart by
approximately a length of the energy application device.
[0166] In another embodiment, an apparatus for treating a hollow
anatomical structure is disclosed that comprises: an elongate
electrically driven heater that extends from a distal end thereof
to a proximal end thereof; and a visibility-enhancing element
adjacent to one of the proximal and distal ends.
[0167] In a variation of the apparatus, the visibility-enhancing
element is configured to facilitate viewing a position of the
electrically driven heater within the hollow anatomical structure.
In a further variation, the visibility-enhancing element is a light
emitter.
[0168] In another variation of the apparatus, the
visibility-enhancing element is a portion of the apparatus that is
relatively highly reflective of ultrasound. In a further variation,
the visibility-enhancing element comprises a gas bubble delivery
port adjacent to one of the proximal and distal ends.
[0169] In another variation of the apparatus, the heater is coupled
to an elongate shaft having an outer surface, and the
visibility-enhancing element is a portion of an outer surface of
the shaft, which portion is configured to trap one or more gas
bubbles.
[0170] In another variation of the apparatus, the
visibility-enhancing element is a portion of the apparatus that is
relatively highly radiopaque.
[0171] In another variation of the apparatus, the electrically
driven heater has a length greater than the width thereof. In a
further version, the electrically driven heater is a closed circuit
heater.
[0172] In another embodiment, an apparatus for treating a hollow
anatomical structure is disclosed that comprises: an elongate
therapeutic energy source; a first visibility-enhancing element
adjacent to a proximal end of the elongate therapeutic energy
source; and a second visibility-enhancing element adjacent to a
distal end of the elongate therapeutic energy source.
[0173] In a variation of the apparatus, the first and second
visibility-enhancing elements are configured to facilitate viewing
a position of the therapeutic energy source within the hollow
anatomical structure. In a further variation, the first and second
visibility-enhancing elements are light emitters. In a further
variation, the first and second visibility-enhancing elements are
ultrasound emitters. In a further variation, the first and second
visibility-enhancing elements are portions of the apparatus that
are relatively highly radiopaque.
[0174] In another variation of the apparatus, the therapeutic
energy source has a length greater than the width thereof. In a
further variation, the therapeutic energy source has a fixed
profile in a plane orthogonal to a longitudinal axis of the
therapeutic energy source.
[0175] In certain embodiments, systems and methods are disclosed
for endovascular vein treatment using a catheter with an integrated
heating element.
[0176] In one embodiment, a catheter comprises an elongate shaft
and a resistive heating element located near the distal end of the
elongate shaft. A temperature-sensing element is located in
proximity to the resistive heating element and may be centered
along the length of the heating element or may be offset from
center. The resistive heating element may comprise a coil, and the
coil may be of a constant pitch wind or of a varying pitch.
[0177] In one embodiment, a catheter comprises an elongate shaft
and a resistive heating element located near the distal end of the
elongate shaft. A sheath is slidably disposed on the shaft. The
sheath and catheter are relatively movable between a first
configuration, in which the sheath substantially covers the entire
resistive heating element, and a second configuration in which the
sheath covers less than the entire resistive heating element. The
resistive heating element may comprise a coil, and the coil may be
of a constant pitch or of a varying pitch. In certain embodiments,
the sheath may have thermally-conductive and/or insulative
properties in order to maintain a particular heat output along the
heating element while the length of heat input to the HAS is
reduced.
[0178] In one embodiment, a catheter system comprises an elongate
shaft and an energy-emission element located near the distal end of
the elongate shaft. The energy-emission element optionally includes
a plurality of emission segments, and each of the segments is
independently operable to emit energy into the surroundings of the
energy-emission element. Optionally, the catheter system further
comprises a power source drivingly connected to the emission
segments. The power source is operable pursuant to a multiplexing
algorithm to deliver power to, and operate, the emission segments
in a multiplexed fashion. In one embodiment, the energy-emission
element comprises a resistive element such as a resistive coil. In
another embodiment, the energy-emission element comprises a radio
frequency (RF) emitter.
[0179] In another embodiment, a catheter system comprises an
elongate shaft and an energy-emission element located distal of the
elongate shaft. The energy-emission element has an effective axial
length along which the energy-emission element emits energy. In
certain embodiments, the effective axial length of the
energy-emission element is adjustable.
[0180] In another embodiment, a catheter comprises an elongate
shaft and an expandable shaft located on a distal portion of the
elongate shaft. A number of heater elements are expandable by a
balloon. The heater elements may have a wavy, sinusoidal and/or
serpentine configuration.
[0181] For purposes of summarizing the invention(s) disclosed
herein, certain aspects, advantages and novel features of the
invention(s) have been described herein. It is to be understood
that not necessarily all such advantages may be achieved in
accordance with any particular embodiment of the invention(s).
Thus, the invention(s) may be embodied or carried out in a manner
that achieves or optimizes one advantage or group of advantages as
taught herein without necessarily achieving other advantages as may
be taught or suggested herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0182] FIG. 1 illustrates an overall view of a resistive element
system usable to treat a hollow anatomical structure.
[0183] FIG. 2 illustrates one embodiment of a catheter sheath in a
partially retracted position usable with the resistive element
system of FIG. 1.
[0184] FIG. 3 illustrates a magnified view of an exemplary
embodiment of a therapeutic element of a catheter usable with the
resistive element system of FIG. 1.
[0185] FIG. 4 illustrates a cross-sectional side view of the
therapeutic element (i.e., working end) of the catheter of FIG.
3.
[0186] FIG. 5 illustrates a side view of another embodiment of a
working end of the catheter of FIG. 3.
[0187] FIG. 6 illustrates a side view of yet another embodiment of
a working end of the catheter of FIG. 3.
[0188] FIG. 7A illustrates a side view of yet another embodiment of
a working end of the catheter of FIG. 3, wherein the working end
comprises multiple treatment segments.
[0189] FIG. 7B is a table depicting an exemplary treatment cycle
usable with multiplexing the treatment segments of the catheter of
FIG. 7A.
[0190] FIG. 7C illustrates two views of an embodiment of a catheter
incorporating external fluid grooves and an external coil
electrode.
[0191] FIG. 7D illustrates an embodiment of a resistive element
system having multiple protruding resistive elements.
[0192] FIG. 7E illustrates a side view of a resistive element
system including an expandable balloon and a set of fluid
ports.
[0193] FIG. 8 illustrates another embodiment of a resistive element
device having an expandable electrode.
[0194] FIG. 9 illustrates yet another embodiment of a resistive
element device having an expandable braid electrode.
[0195] FIG. 10A illustrates an embodiment of a working portion of a
catheter body with individually expandable loops usable to treat a
hollow anatomical structure.
[0196] FIGS. 10B-10D illustrate other embodiments of a working
portion of a catheter body usable to treat a hollow anatomical
structure.
[0197] FIG. 11 illustrates an exemplary embodiment of an expandable
set of spline electrodes capable of conforming and contacting a
vein wall.
[0198] FIG. 12A illustrates an embodiment of the working portion of
a catheter having a conformable helical electrode axially coiled on
a shaft.
[0199] FIG. 12B illustrates the electrode of the device of FIG. 12A
being radially expanded by rotation of a distal catheter
portion.
[0200] FIG. 12C illustrates the electrode of the device of FIG. 12B
expanded and compressed distally to remove inter coil gaps.
[0201] FIG. 13A illustrates an exemplary embodiment of a strip
electrode coiled substantially normal to a catheter shaft axis.
[0202] FIG. 13B illustrates an exemplary embodiment of the device
of FIG. 13A uncoiled to flatten out the multiple strip
electrodes.
[0203] FIG. 14 illustrates an exemplary embodiment of an indexing
treatment system for hollow anatomical structures.
[0204] FIG. 15A illustrates an exemplary embodiment of a catheter
having markings usable with an embodiment of an indexing treatment
system for hollow anatomical structures.
[0205] FIG. 15B illustrates an exemplary embodiment of a catheter
having markings and illumination holes usable with an indexing
treatment system for hollow anatomical structures.
[0206] FIGS. 16A-16D illustrate another exemplary embodiment of a
catheter usable with an embodiment of an indexing treatment system
for hollow anatomical structures.
[0207] FIG. 16E illustrates another exemplary embodiment of a
catheter usable with an embodiment of an indexing treatment system
for hollow anatomical structures.
[0208] FIG. 16F illustrates a magnified view of an indexing portion
of the catheter of FIG. 16E.
[0209] FIG. 16G illustrates another exemplary embodiment of a
catheter usable with an embodiment of an indexing treatment system
for hollow anatomical structures.
[0210] FIG. 16H illustrates exemplary embodiments of introducers
usable with embodiments of an indexing treatment system for hollow
anatomical structures.
[0211] FIGS. 17A and 17B illustrate exemplary embodiments of
markings usable for visual verification of indexing positions of a
catheter.
[0212] FIGS. 18A and 18B illustrate other exemplary embodiments of
markings usable for visual verification of indexing positions of a
catheter.
[0213] FIG. 19 illustrates an exemplary embodiment of a movable
datum device usable with an indexing treatment system.
[0214] FIG. 20 illustrates another exemplary embodiment of a
movable datum device usable with an indexing treatment system.
[0215] FIGS. 21A-21D illustrates another exemplary embodiment of an
indexing device usable for treatment of a hollow anatomical
structure.
[0216] FIG. 22A illustrates an exemplary embodiment of an indexing
system having a sensor configured to detect markings on a catheter
shaft.
[0217] FIG. 22B illustrates another exemplary embodiment of an
indexing system having a sensor configured to detect detents on a
catheter shaft.
[0218] FIG. 23 illustrates an exemplary embodiment of an indexing
system having a temperature sensor.
[0219] FIG. 24 illustrates an exemplary embodiment of an indexing
system having multiple temperature sensors.
[0220] FIGS. 25A and 25B illustrate an exemplary embodiment of an
indexing device usable for facilitating manual indexed movement of
a catheter.
[0221] FIGS. 26A and 26B illustrate other exemplary embodiments of
indexing devices usable for facilitating manual indexed movement of
a catheter.
[0222] FIG. 27 illustrates an exemplary embodiment of an indexing
device having linkage arms usable for facilitating indexed movement
of a catheter.
[0223] FIGS. 28A and 28B illustrate other exemplary embodiments of
an indexing device having linkage arms usable for facilitating
indexed movement of a catheter.
[0224] FIGS. 29A-29E illustrate a method of using the indexing
device of FIG. 28A to perform an indexed movement of a catheter
during a treatment process.
[0225] FIGS. 30A and 30B illustrate exemplary embodiments of
automatic indexing systems including a mechanical indexing
handle.
[0226] FIGS. 31A-31D illustrate exemplary embodiments of indexing
systems having controls and/or a remote device to control power
applied by a therapeutic element during a treatment process.
[0227] FIG. 32 illustrates a screen shot of an exemplary embodiment
of a control system display usable with an indexing system.
[0228] FIG. 33 illustrates an exemplary flowchart of an indexed
treatment process.
[0229] FIGS. 34A-34C illustrate an exemplary flowchart of an
embodiment of a method of a system for treating hollow anatomical
structures.
[0230] FIG. 35 illustrates an exemplary graph depicting
temperature, power and resistance values during a treatment
process.
[0231] FIG. 36A illustrates another embodiment of an indexing
treatment system for hollow anatomical structures.
[0232] FIG. 36B illustrates another embodiment of an indexing
treatment system for hollow anatomical structures.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0233] The features of the systems and methods will now be
described with reference to the drawings summarized above. The
drawings, associated descriptions, and specific implementation are
provided to illustrate embodiments of the invention(s) disclosed
herein, and not to limit the scope of the disclosure.
[0234] In addition, methods and functions of treatment systems or
devices described herein are not limited to any particular
sequence, and the acts or blocks relating thereto can be performed
in other sequences that are appropriate. For example, described
acts or blocks may be performed in an order other than that
specifically disclosed, or multiple acts or blocks may be combined
in a single act or block.
[0235] FIG. 1 illustrates an embodiment of a resistive element
system 10 for applying energy to a hollow anatomical structure
(HAS) (e.g., the wall of the HAS). For example, a HAS may include,
but is not limited to, a vein, such as a greater saphenous vein, a
short saphenous vein, a tributary vein, a perforator vein, a
varicose vein, or the like. As illustrated, the resistive element
system 10 comprises a catheter 11. The catheter 11 includes a
catheter shaft 13, which may be used to maneuver a distal portion
14 of the catheter 11 into a desired placement within the HAS. In
certain embodiments, the catheter shaft 13 comprises a
biocompatible material having a low coefficient of friction. For
example, the shaft 13 may comprise PEEK, Polyethylene or
TEFLON.RTM.. In other embodiments, the shaft 13 may comprise
Polymide, HYTREL.RTM., PEBAX.RTM., nylon or any other such suitable
material.
[0236] In certain embodiments, the catheter shaft 13 is sized to
fit within a vascular structure that may be between approximately
one millimeter and approximately twenty-five millimeters in
diameter and, preferably, between approximately two millimeters and
approximately 18 millimeters. For instance, the catheter shaft 13
may have a maximum outer diameter of between approximately four
French and approximately eight French and, more preferably, between
approximately six French and approximately seven French. In yet
other embodiments, other sizes of catheters may be used. In certain
embodiments, the distal portion 14 transfers energy (e.g., heat)
directly to an inner wall of a HAS. The proximal end of the
catheter has a handle 15. In certain embodiments, the handle 15 may
include a connection 16 for interfacing with an energy source 18
and a port for fluid or guidewire passage (e.g., a 0.014'',
0.018'', 0.035'' or preferably a 0.025'' guidewire).
[0237] In certain embodiments, the energy source 18 comprises an
alternating current (AC) source, such as an RF generator. In other
embodiments, the energy source 18 comprises a direct current (DC)
power supply, such as, for example, a battery, a capacitor, or
other energy source such as would be used for microwave heating.
The energy source 18 may also incorporate a controller that,
through the use of a processor, applies power based at least upon
readings from a temperature sensor 12 or sensors (e.g., a
thermocouple, a thermistor, a resistance temperature device, an
optical or infrared sensor, combinations of the same or the like)
located in the working portion (e.g., therapeutic portion) of the
catheter 11. For example, the controller may heat the tissue of a
HAS or the therapeutic region of the catheter to a set temperature.
In an alternative embodiment, the user selects a constant power
output of the energy source 18. For example, the user may manually
adjust the power output relative to the temperature display from
the temperature sensor 12 in the working portion of the catheter
11.
[0238] FIG. 1 thus illustrates one embodiment of a hollow
anatomical structure therapy system. The system comprises an energy
application device suitable for insertion into a hollow anatomical
structure; a power source in communication with the energy
application device, the power source comprising a processor and
program instructions executable by the processor such that the
power source is operable to: (a) deliver power to the energy
application device during a first power delivery phase; (b) measure
time elapsing during power delivery; (c) assess performance of the
therapy system during the first power delivery phase; and (d) if
the performance of the therapy system during the first power
delivery phase is satisfactory, deliver power to the energy
application device during a second power delivery phase.
[0239] In variations of this system, the energy application device
may be an electrically driven heating element, an electrode, or a
laser. The electrically driven heating element may comprise a coil
or any other heating element structure known in the art, and is
provided with an energy coupling surface for applying energy to the
hollow anatomical structure being treated. In a further variation,
the distal-to-proximal length of the heating element along the
energy coupling surface is at least fifteen times the width of the
heating element. The electrode may be any electrode known in the
art suitable for applying energy to a hollow anatomical structure.
Furthermore, the laser employed may be any laser known in the art
to be suitable for applying energy to a hollow anatomical
structure.
[0240] In further variations of the system, the energy application
device may be coupled to the shaft of a catheter suitable for
insertion into a hollow anatomical structure such as a vein to
facilitate the placement of the energy application device within
the hollow anatomical structure. Conventional catheters sized to
access small vasculature that are known in the art may be employed
for this purpose.
[0241] In other variations of the therapy system, the system may
also comprise a temperature sensor configured to sense either or
both of (i) a temperature of at least a portion of the energy
application device, and (ii) a temperature of tissue in thermal
communication with said energy application device. The temperature
sensor may comprise a thermocouple, a thermistor, a resistive
temperature device (RTD) or a set of contacts that measures
resistance. FIG. 1 shows an example of this in which the
temperature sensor 12 is placed at the distal portion 14 of the
catheter 11.
[0242] In other variations of the system, the program instructions
are executable by the processor such that the power source is
further operable to: deliver power to the energy application device
to reach a first treatment temperature; and deliver power to the
energy application device to reach a subsequent second treatment
temperature which is lower than the first treatment temperature.
The program instructions may also be executable by said processor
such that the power source is further operable to determine
expiration of the first power delivery phase based on temperature
measurement results obtained by the temperature sensor. In one
variation, the first power delivery phase is 10 seconds or less in
duration. In a further variation, the program instructions are
executable by the processor such that the power source is further
operable to determine expiration of the first power delivery phase
when the temperature sensor senses a target temperature within a
time limit.
[0243] In further variations of the system, satisfactory
performance of the therapy system comprises reaching or exceeding a
target temperature within a time limit. In further variations, the
program instructions are executable by the processor such that the
power source proceeds to the second power delivery phase only when
the temperature sensor senses the target temperature within the
time limit. In one variation, the time limit is six seconds or
less. In a further variation, the target temperature is
approximately 120 degrees Celsius.
[0244] In other variations, the combined duration of the first
power delivery phase and the second power delivery phase is 60
seconds or less.
[0245] In other embodiments, the hollow anatomical structure
therapy system comprises: a heat delivery device suitable for
insertion into a hollow anatomical structure; a power source in
communication with said heat delivery device, the power source
being programmed to: (a) deliver power to the heat delivery device
during a temperature ramp-up phase; (b) measure time elapsing
during power delivery; (c) monitor operation of the heat delivery
device; and (d) if the operation of the heat delivery device either
during or shortly after the temperature ramp-up phase is
acceptable, deliver power to the heat delivery device after the
temperature ramp-up phase.
[0246] In further variations, the heat delivery device is selected
from the group consisting of an electrically driven heating
element, an electrode, and a laser. When the heat delivery device
comprises an electrically driven heating element, the heating
element may be provided with an energy coupling surface having a
distal-to-proximal length which is at least fifteen times the width
of the heating element.
[0247] In further variations, the system is provided with a
catheter having a shaft to which the heat delivery device is
coupled.
[0248] In further variations, the system is provided with a
temperature sensor configured to sense at least one of (i) the
temperature of a portion of the heat delivery device, and (ii) the
temperature of tissue in thermal communication with the heat
delivery device.
[0249] In further variations of the system, acceptable operation of
the heat delivery device during or shortly after said temperature
ramp-up phase comprises reaching or exceeding a target temperature
within a time limit. In other variations, acceptable operation of
said heat delivery device during or shortly after the temperature
ramp-up phase comprises falling below a target temperature within a
time limit. In another variation, the combined duration of the
temperature ramp-up phase and a subsequent power delivery phase is
60 seconds or less.
[0250] In another variation, the power source is further programmed
to: deliver power to the heat delivery device to reach a first
treatment temperature; and deliver power to the heat delivery
device to reach a subsequent second treatment temperature which is
lower than the first treatment temperature.
[0251] For example, in certain preferred embodiments, the energy
source 18 may comprise an RFGPlus.TM. RF generator supplied by VNUS
Medical Technologies, Inc. (San Jose, Calif.). In other
embodiments, the energy source 18 may comprise other types of RF or
energy-delivering generators usable to power the working portion of
the catheter 11. For example, details of RF generators that may be
used with the embodiments of the catheters disclosed herein are
further disclosed in the following patents, the entirety of each of
which is hereby incorporated herein by reference to be considered
part of this specification: U.S. Pat. No. 6,071,277, issued Jun. 6,
2000; U.S. Pat. No. 6,152,899, issued Nov. 28, 2000; U.S. Pat. No.
6,165,172, issued Dec. 26, 2000; U.S. Pat. No. 6,179,832, issued
Jan. 30, 2001; U.S. Pat. No. 6,200,312, issued Mar. 13, 2001; U.S.
Pat. No. 6,237,606, issued May 29, 2001; U.S. Pat. No. 6,258,084,
issued Jul. 10, 2001; U.S. Pat. No. 6,322,559, issued Nov. 27,
2001; U.S. Pat. No. 6,401,719, issued Jun. 11, 2002; U.S. Pat. No.
6,638,273, issued Oct. 28, 2003; U.S. Pat. No. 6,752,803, issued
Jun. 22, 2004; and U.S. Pat. No. 6,769,433, issued Aug. 3,
2004.
[0252] FIG. 2 illustrates another embodiment of a resistive element
system 20. As shown, a catheter 21 includes an outer retractable
sheath 22. The sheath 22 is advantageously used to protect the
device during placement, facilitate introduction of the device,
and/or adjust the exposed axial length of the resistive element 14
(i.e., therapeutic element) for a user-selected and/or variable
treatment length. For example, the sheath 22 may be used (e.g.,
pulled back (proximally) or pushed forward (distally)) to adjust
the length of the heated region of the resistive element 14 that is
exposed to a wall of the HAS. In certain embodiments, the sheath
may comprise a material or materials that insulates the inner wall
of the HAS from receiving thermal energy above a therapeutic
temperature and/or that conducts thermal energy away from the
resistive element to reduce build-up of heat surrounding the
portion of the resistive element that is covered by the sheath.
[0253] FIG. 2 further shows an optional sensor 23 coupled to the
sheath 22 and the shaft 13. In other embodiments, multiple sensors
are placed along the axial resistive element length. For example,
an energy source may advantageously monitor the individual sensors
and use data received therefrom for temperature feedback. In
another embodiment, a controller may monitor for high temperature
or low temperature signals. For example, an algorithmic process may
be used to control the current applied to the various wire coils,
thus maintaining a substantially axially-uniform temperature and/or
heat output.
[0254] FIG. 3 illustrates a catheter with a cross-section 4-4 of
the resistive element 14, which is further depicted in FIG. 4. In
one embodiment, a thermally-conductive tip 30 or extension near the
tip is used to extend heating toward the distal tip of the
catheter. In certain embodiments, optional features at or near the
distal tip and/or the proximal end of the heating coil may assist
in ultrasound visibility (e.g., a rough surface such as caused by
grit-blasting, or slots, holes or fins). FIG. 4 illustrates a
detailed cross-sectional portion of the resistive element 14 and
internal components of the catheter. As will be appreciated, the
distance between the illustrated adjacent coils of the resistive
element 14 may be of consistent or varied spacing.
[0255] The distal section of the catheter in FIG. 4 shows the
resistive element 14 covered by a sleeve 47. In one embodiment, the
sleeve 47 is a thin-walled tube from approximately 0.002 inch to
approximately 0.010 inch thick. In other embodiments, the sleeve 47
may have a wall thickness of less than 0.00025 inch or of more than
0.003 inch. In one embodiment, the sleeve 47 comprises a non-stick
material such as TEFLON.RTM. (FEP, PTFE) and/or a non-stick coating
such as silicone or a hydrogel. In other embodiments, the sleeve 47
may comprise PET (polyethylene terephthalate), polyimide or other
thin-walled sleeve material that remains substantially stable and
resists damage at temperatures well above the desired temperature
range. The sleeve material may also be preferably chosen to provide
uniformity of heating along the full length of the heating coil,
with a defined temperature offset (e.g., a predictable gradient
between the heating coil within the sleeve and the outer diameter
which is in contact with the HAS). The material selection process
of sleeve 47 may be determined by using polymers with nonconductive
or electrically insulative properties. In certain embodiments, it
may be desirable to maintain a property of the catheter surface
that gives the user tactile feedback of HAS shrinkage after
treatment (such as, for example, a detectable slight friction).
[0256] FIG. 4 also shows an internal lumen 48 of the catheter,
which communicates through an open lumen, such as from a distal tip
to a proximal handle. In one embodiment, the lumen 48 is used for
delivery of fluids, such as for example, saline, a venoconstrictor,
sclerosant, high-impedance fluid, physiologic tissue adhesive,
hydrogel, combinations of the same or the like. In addition, upon
completion of treatment, a sclerosant and/or a hydrogel may be
exuded from the distal catheter end, allowing for substantially
complete vessel occlusion. For example, the hydrogel may be
biocompatible or bioresorbable. In other embodiments, the hydrogel
may be displaced by the constriction of the HAS resulting from the
thermal injury response, which results in substantially complete
occlusion. In those sections of the HAS in which the fluid material
has not completely compressed the HAS wall, the fluid material may
be naturally resorbed by the body.
[0257] In yet other embodiments, the lumen 48 may also accommodate
a guide wire for catheter placement. In certain embodiments, the
lumen 48 may accommodate an optical fiber for additional laser
energy delivery and/or to provide guiding illumination to indicate
the location of the distal end of the catheter as transmitted and
visualized through tissue. In yet other embodiments, the lumen 48
may be of the Rapid Exchange variety to allow a guidewire to pass
through a distal portion of the catheter shaft.
[0258] In certain embodiments, the resistive element 14 of the
catheter is made of resistive wire that generates heat when an
energy source (e.g., energy source 18 of FIG. 1) is connected and
applied thereto. As shown in FIG. 4, the resistive element 14
comprises a wire having a round cross-section, wound on top of an
inner shaft layer or layers 46. In particular, the resistive
element 14 may comprise a round bifilar wire having an insulative
layer that holds wires together. In certain embodiments, the
insulative layer preferably comprises a polyimide or like material.
In certain preferred embodiments, a spacing of approximately
one-half the wire diameter exists between the insulative layers of
adjacent bifilar wires. As shown in FIG. 4, a temperature sensor
11, such as a thermocouple, is incorporated into the resistive
element by being located within a suitable gap between coil
windings.
[0259] In other embodiments, the cross-section of the resistive
element 14 may alternatively be oval, rectangular, or another
geometrical cross-section. Preferably, the relative resistance or
impedance of the resistive element 14 is designed to correlate to,
or match, the energy source. For example, the resistance of
resistive element 14 may be determined by a wire gage that relates
to the catheter diameter, the energy required during treatment,
and/or the energy source specifications. The resistive element 14
may comprise a wide variety of conductive materials, such as, for
example, nickel chromium (NICHROME.RTM.), Alloy 52, copper,
stainless steel, titanium, zirconium, NITINOL.RTM., ALUMEL.RTM.,
KANTHANAL.RTM., CHROMEL.RTM., KOVAR.RTM., combinations or alloys of
the same and the like. The material for the resistive coil or
resistive element 14 can be chosen to provide Resistance
Temperature Detector (RTD) functionality, wherein temperature is
indirectly measured as a function of impedance. Alloy 52 is
considered to be one material suitable for providing RTD
functionality to the resistive element 14.
[0260] The resistive element 14 illustrated in FIG. 4 is nearly a
close-pitch (or closed-wind) coil (i.e., with very little
inter-coil spacing). In one embodiment, an electrical connection,
such as soldering at the proximal end and/or the distal end of the
coil, couples the resistive element 14 to signal wires 49. As shown
in FIG. 4, the signal wires 49 are coupled at the distal end of the
resistance coil. For example, the signal wire 49 may connect at the
distal end of the resistive element 14 and run internally the
length of the catheter to a connector cable. In one embodiment, the
signal wires 49 extend from the proximal end of the coil. In such
an embodiment, the signal wire 49 is preferably a larger gage
copper wire (e.g., 28 to 34 gage) to reduce possible heating within
the main body of the catheter.
[0261] The radially outwardly disposed portions of the resistive
element 14 function as an energy coupling surface which extends
generally along the length of the resistive element. When the
resistive element 14 comprises a coil, the energy coupling surface
typically comprises the (roughly) cylindrical outer surface of the
coil, and extends from the proximal edge of the coil to the distal
edge thereof. In this example, the cylinder comprises an
energy-coupling surface in that substantially the entire cylinder
becomes heated and transfers heat to the surrounding portions of
the HAS in a typical treatment. Where additional, highly thermally
conductive portions are positioned longitudinally adjacent to the
coil, these outer surfaces of these portions can be considered part
of the energy coupling surface, if the adjacent portions reach a
treatment temperature during normal operation of the coil. Thus,
for coil-type resistive elements, the energy coupling surface
extends along the entire active portion of the coil, and along any
thermally active portions adjacent to the coil. Where the catheter
includes a coating (such as a lubricious coating) over the coil,
the outer surface of the coating can be considered an energy
coupling surface, as heat transfer to the HAS will take place where
portions of the HAS contact (or are otherwise in thermal
communication with) the outer surface of the coating.
[0262] When in the form of a resistive heating coil, the resistive
element 14 generates heat internally, within the winds of the coil,
and transfers heat radially outwardly to the HAS from the central
longitudinal axis of the coil/catheter. The heat is transferred via
the energy coupling surface (whether the outer coil surface itself
or a coating forms the energy coupling surface) to the inner wall
of the HAS, either through direct contact and conduction, or
through intervening media, such as fluids, etc.
[0263] In one embodiment, the resistive element 14 comprises a
constant, closed-pitch coil. Alternatively, the resistive element
14 may have a varying pitch and/or a varying inter-coil spacing.
For example, a varying coil pitch and/or spacing may be
advantageously used to vary the heat output over the axial length
of the resistive element 14. An axially (and/or radially) varying
heat output from the resistive element 14 may be useful in
providing a substantially uniform tissue and/or device temperature
during treatment.
[0264] For example, such a variation in coil pitch may be
advantageous in situations involving fluid flow within the HAS. In
such embodiments, wherein fluid runs from the direction of the
proximal end of the catheter towards the distal end of the
catheter, fluid tends to absorb heat output from the proximal
portion of the resistive element 14 to a greater degree than heat
output from the distal portion. Such may result in a reduction of
the heat actually applied to the wall of the HAS adjacent to the
proximal portion of the resistive element 14 relative to the
central and distal sections. As the fluid flows past the proximal
section of the resistive element 14, the fluid itself is heated.
The heated fluid then flows across the middle and distal sections
of the resistive element 14, thereby increasing the temperature of
treatment for these sections. Furthermore, a tighter wind pitch at
the ends of the resistance element 14 may balance any edge-effect
heating losses that may otherwise cause a drop in heat intensity at
the ends of the resistance element 14.
[0265] Certain embodiments, intended to counteract this uneven heat
distribution, comprise a close-pitch wind of the resistive element
14 in the proximal portion (providing a higher heat output in the
proximal portion), while the middle and distal sections have a
comparatively more open-pitch wind (i.e., the inter-coil spacing
increases in the distal direction). This configuration
advantageously decreases the heat output along portions of the coil
in order to compensate for the added heat from the proximal
adjacent sections. That is, the variable coil pitch may be used to
correct for higher temperatures of the middle sections of the
resistive element 14 in comparison with lower temperatures of the
end sections of the resistive element 14. A thermally-insulating
material (such as natural rubber, silicone, or an elastomer) may
also be used to shield the internal lumen 48 from heating and/or to
selectively reduce external heat transfer from the resistive
element 14.
[0266] In another embodiment, portions of the resistive element 14
having a close-pitch wind are used to heat larger portions of a HAS
(e.g., portions having a larger diameter) while portions of the
resistive element 14 having an increased coil spacing are used to
heat smaller portions of the HAS (e.g., portions having a smaller
diameter).
[0267] In other embodiments, the coil wind comprises more than one
radially displaced layer. For example, as shown in FIG. 5, a
resistive element 50 advantageously comprises two layers 54 and 55
of winds that are counter-wound to overlap. These layers 54 and 55
may also have a variable pitch over the axial length of the
catheter shaft. Such a configuration may be used to provide a
greater heating density and/or to provide more uniform heating if
the coil winds are spaced to increase the length of the heating
segment while using a limited length of coil wire.
[0268] In the embodiment shown in FIG. 6, the resistive element
comprises a bifilar wire coil, which is advantageous in processing
since it can be wound as a single filament. A bifilar wire also
maintains a substantially constant distance between the two
embedded wires, which can help to maintain accurate overall spacing
in order to provide uniform heat distribution. In some embodiments,
the wind of the bifilar wire coil may comprise a variable pitch, as
discussed previously. In certain embodiments, the bifilar wire coil
may also combine wire connections (i.e., connections between the
multiple wires in the wire coil) at one end of the catheter, such
as the proximal end. In certain embodiments, for example, the
distal end may also comprise an electrical connection between the
two wire ends in order to create a continuous loop. In alternative
embodiments, the bifilar wire may comprise more than two wires.
[0269] FIG. 6 shows a bifilar wire 60 coupled through solder joints
62 to signal wires 64 and 66. In certain embodiments, the joints 62
are spot welded or bonded with a conductive epoxy. In addition, the
signal wires 64 and 66 may extend internally through the catheter
shaft to a connector located at the proximal end (e.g., connector
16 of FIG. 1). FIG. 6 further shows one example of a variable wind
configuration, as discussed previously.
[0270] In other embodiments, energy is applied separately to each
wire of the bifilar wire coil. For example, applying energy
separately to each wire may be used to vary and control the power
and heat transferred from the device to the HAS. In one embodiment,
a single coil is used for a relatively smaller HAS, while a
plurality of coils are used with a relatively larger HAS.
[0271] In another embodiment, as shown in FIG. 7A, a resistive
element 70 comprises multiple coils or electrodes, which are
sequentially placed axially on the catheter shaft. For example,
FIG. 7A illustrates the resistive element 70 including eight such
coils, which are identified as elements 71-78. In certain
embodiments, each resistive element 71-78 may be individually
temperature controlled and/or may comprise a temperature sensor.
Alternatively, the resistive elements 71-78 may be used in a power
control mode that relies on manual energy control.
[0272] Alternatively, in embodiments having multiple resistive
elements, a temperature sensor is located on the most distal
resistive element (e.g., element 71) or other resistive element.
For example, the most distal resistive element may be used for the
initial treatment, and the successive coil electrodes may use the
same and/or a predetermined energy-time profile.
[0273] In certain embodiments, a method of use of the resistive
element 70 includes multiplexing through each of the resistive
elements 71-78 shown in FIG. 7A. The term "multiplex" as used
herein is a broad term and is used in its ordinary sense and
includes, without limitation, the energizing or heating of at least
one resistive element for a specific dwell time and cascading, or
moving, to another resistive element until a final resistive
element is reached or until a cycle is completed. In certain
embodiments, the cycle may then be repeated until the complete
treatment time is reached.
[0274] FIG. 7B depicts a table illustrating the use of the
resistive element configuration 70 shown in FIG. 7A. In one
embodiment, the resistive elements 71 through 78 are sequentially
energized for a dwell time of approximately 0.2 second. In the
example shown, three resistive elements are powered at one time. In
particular, the table has shaded blocks of time that represent the
time that energy is delivered to the specified resistive elements.
Since three resistive elements are powered at one time, and the
dwell time is 0.2 second, each resistive element is on for a total
of approximately 0.6 second during one cycle. As illustrated by the
table, for time 0 to time 0.2 second, resistive elements 71, 72 and
73 are energized. For time 0.2 second to 0.4 second, resistive
elements 72, 73 and 74 are energized. This process repeats by
stepping through the resistive element set. For the eight resistive
elements shown, one complete cycle takes approximately 1.6
seconds.
[0275] In one embodiment, to avoid overcooling a particular
resistive element, the cycle time is of a shorter duration and/or
the total number of resistive elements is limited. That is, in
certain embodiments, a resistive element may be re-energized before
substantial cooling takes place. In addition, in one embodiment, to
increase the treatment zone the catheter may comprise multiple
treatment zones, such as for example, groups of eight resistive
elements. Each group of eight resistive elements may treat the wall
of the HAS before energy is applied to the next group of resistive
elements. Alternative modes of multiplexing may also be employed.
For example, the number of adjacent resistive elements
simultaneously energized may vary. Also, the entire cycle may
re-start at the first energized resistive element or the most
recent energized resistive element. Another mode of multiplexing
may be accomplished while sensing the tissue impedance. Once a
certain impedance level is achieved, the next set of resistive
elements is then energized.
[0276] Alternatively, at least one of the eight resistive elements
71-78 is energized to treat the HAS until treatment is complete.
Then, the next resistive element(s) apply heat for a similar
treatment time, and so on, moving along the treatment zone. For the
eight resistive elements 71-78 illustrated in FIG. 7A, the
treatment may be for one cycle. For example, resistive element 71
may treat the HAS for approximately 20 seconds. Once resistive
element 71 has completed treatment, resistive element 72 repeats
the treatment for the same treatment time and energy settings. Such
a process may continue for resistive elements 73 through 78.
[0277] In other embodiments, other treatment cycles may be used.
For example, resistive elements 71 and 72 may concurrently treat
the HAS for approximately 20 seconds. Then resistive elements 73
and 74 may apply a similar treatment, and so forth, through
resistive elements 77 and 78 to complete the cycle.
[0278] FIG. 7C illustrates an embodiment of an electrically
resistive heating element 80 having an open pitch wind, but
omitting the depiction of an outer sleeve. In particular, FIG. 7C
shows a coil spacing greatly exaggerated in order to see details of
a catheter tube 82. In one embodiment, the inter-coil spacing is
selected to create a path for fluids. For example, an inner lumen
84 (which is shown as a single lumen, but may include multiple
lumens) of the catheter may deliver fluid to a HAS by pathways 86,
which are external surface features and radial holes
(intermittently spaced along the grooves) in the tube 82 wall. The
fluid may be a saline, a venoconstrictor or the like. In one method
for using the device 80 of FIG. 7C, the device 80 is placed in the
HAS. The HAS is then treated with a venoconstrictor via the
catheter lumen 84 and the pathways 86. The HAS is then treated by
heating the constricted wall of the HAS.
[0279] FIG. 7D illustrates an embodiment of a resistive heating
element 87 having separate and distinct protruding resistive
elements 88 made of resistive materials, such as, for example,
KANTHANAL.RTM., NICHROME.RTM., CHROMEL.RTM., ALUMEL.RTM.,
KOVAR.RTM., Alloy 52, titanium, zirconium, combinations or alloys
of the same or the like. In certain embodiments, a series of
resistive elements 88 is spaced axially along a catheter shaft 89,
wherein each of the resistive elements 88 comprises a
doubly-truncated-spherical body. In one embodiment, each resistive
element 88 may be further attached to a signal wire by solder, spot
weld or other like method. For example, the signal wire may run
internal to the catheter shaft 89 and attach to a cable and/or a
connector.
[0280] FIG. 7E illustrates another example of a working portion of
a catheter according to certain embodiments. The device shown has
the addition of a balloon 90 expanded by at least one port 91. As
shown, the balloon 90 is located proximate to a resistive element
92. The balloon 90 may be used in conjunction with the resistive
element 92 to occlude or substantially occlude a HAS. At least one
additional fluid port 93 proximal to the resistive element 92 may
also be used for fluid placement within the HAS.
[0281] In one embodiment, the catheter is placed in the HAS, and
then the balloon 90 is inflated through the at least one port 91.
Once the balloon 90 is inflated, the at least one fluid port 93
clears the HAS of native fluid, such as blood, distal to the
balloon 90 by injecting a displacing fluid, such as, for example,
saline. In one embodiment, the displacing fluid is followed by
another injection of a venoconstrictor, which reduces the lumen
size of the HAS prior to treatment. By a temporary reduction of the
size of the HAS, the treatment time used for the resistive element
92 is advantageously reduced, thereby resulting in a more effective
and safe treatment.
[0282] Expandable Resistive Element Devices
[0283] Serpentine
[0284] Another embodiment of a resistive element device 96 is shown
in FIG. 8, which incorporates an expandable resistive element 98 on
a balloon 100. In one embodiment, the balloon 100 is made of a
biocompatible material such as, but not limited to, silicone, PET,
urethane, latex, C-FLEX.RTM., combinations of the same or the like.
The balloon 100 is attached at one end to a catheter shaft 101 at
the working end of the catheter. In certain embodiments, both ends
of the balloon 100 are sealed on the shaft 101 and are
substantially fluid tight. The catheter shaft section within the
balloon 100 may also contain fluid ports (not shown). The ports may
be connected to lumen(s) which run internally to the shaft 101 to
the proximal end. The lumen(s) at the proximal end (e.g., at a
handle) may be further connected to luer components for external
fluid connections. These components may be used to expand and
collapse the balloon 100.
[0285] The illustrated resistive element 102 is advantageously a
serpentine component, which is placed circumferentially around the
exterior of the balloon 100 and catheter shaft 101. In one
embodiment, the resistive element 102 expands circumferentially as
the balloon 100 expands. In certain embodiments, the resistive
element 102 is made of NITINOL.RTM.. For example, the shape memory
aspect of NITINOL.RTM. may be advantageously utilized to help the
resistive element 102 remember its expanded or collapsed position.
In other embodiments, other nickel-based spring alloys, other
spring alloys, 17-7 stainless steel, Carpenter 455 type stainless
steel, beryllium copper, or other similar materials may be
used.
[0286] In an alternative embodiment, the resistive element 102 is
located within the wall of the balloon material or between two
layers of the silicone balloon material. This embodiment results in
the serpentine resistive element 102 being more integral to the
catheter device 96.
[0287] As shown, a temperature sensor 103 is also advantageously
attached to the resistive element 102 for temperature control
during application of energy to the HAS. In FIG. 8, the sensor 103
is shown attached near a proximal end of the resistive element 102
but may be attached at any point axially. In one embodiment, the
attachment of the sensor 103 is accomplished by soldering, bonding
or tying the sensor 103 onto the section of the resistive element
102. Ends 105 of the resistive element 102 are attached to signal
wires, which may run through an open lumen internal to the catheter
shaft 101 and may be connected to a connector cable. These signal
wires may be attached by solder (or previously discussed methods)
to the resistive element 102.
[0288] The embodiment of FIG. 8 shows the resistive element 102
being capable of being placed in apposition to the wall of a HAS
prior to treatment by use of the expanding balloon 100. Thus, one
device may be advantageously adjusted to fit multiple sizes of
hollow anatomical structures. In certain embodiments, the balloon
100 and resistive element 102 may also collapse during the last
portion of the treatment or as the treatment is completed. One
intent of collapsing the device 96 during the last portion of
treatment is to maintain apposition with the walls of the HAS while
allowing the tissue to shrink and/or constrict so as to occlude or
substantially occlude the structure.
[0289] For improved viewing of the balloon 100 during expansion, a
contrast medium may be used for fluoroscopy or for an ultrasonic
contrast. For example, micro bubbles may be employed as part of the
balloon fluid for expansion. Such a configuration may be applicable
to any expandable resistive element using a fluid filled
balloon.
[0290] In certain embodiments, the balloon 100 is capable of
displacing a substance, such as blood, from a treatment area. In
another embodiment, the balloon 100 is further capable of directing
heat toward the wall of a HAS by bringing at least a portion of the
resistive element 102 in proximity with, or in contact with, the
wall. In yet other embodiments, the balloon 100 is configured to
collapse in response to the collapsing or narrowing of the HAS
and/or is configured to collapse manually.
[0291] In one embodiment, an indicator in the handle of the
resistive element device 96 shows the state of inflation of the
balloon 100. For example, the indicator may comprise a substance or
display that moves axially to show deflation of the balloon 100.
For instance, the indicator may be coupled to the expandable member
(e.g., the balloon 100), such that expansion of the expandable
member causes corresponding changes (e.g., movement) of the
indicator. In other embodiments, the out-flowing saline is employed
in a pressure or level-gauge like configuration (e.g., a
thermometer-like configuration) to indicate the state of inflation
of the balloon 100.
[0292] Expandable Braid
[0293] FIG. 9 illustrates another embodiment of an expandable
resistive heating element device 108. The illustrated heating
element device 108 utilizes a metal braid wire 109 as the working
resistive element. In certain embodiments, the wire 109 is round
and/or made of NITINOL.RTM.. However, in other embodiments, the
braid wire 109 may be a flat wire and/or comprise another
spring-type or shape memory material as discussed above. The
elastic characteristics of NITINOL.RTM., in certain embodiments,
are beneficial to the method of expanding and collapsing the device
108. In one embodiment, the braid wire 109 is heat set in the
nearly fully expanded position. In other embodiments, a balloon 10
is used to expand the braid wire 109.
[0294] In one embodiment, the braid wire 109 is sleeved in
polyimide to isolate the multiple wires from each other where they
overlap. In other embodiments, other materials may be used, such
as, for example, TEFLON.RTM., urethane, and the like. In certain
embodiments, the braid component 109 may be created using standard
braiding technology. Alternatively, a single wire may be woven into
the braid component 109. The particular design of the braid 109 may
be selected for the overall resistance or impedance of the device
108 in view of the corresponding energy source being used.
[0295] The proximal and distal ends of the braid component 109 are
captured in a two-part crimp sleeve, 111 and 112, to anchor the
ends to a catheter tube 113 and a catheter tube stylet 114. The
braid wire 109 in this embodiment is expanded by the use of the
catheter tube stylet 114, which runs the internal axial length of
the catheter from the distal tip 112 to a proximal handle. In
certain embodiments, the proximal end of the stylet 114 passes
through a Touhy Borst type fitting on the catheter handle and
provides, in turn, a handle for stylet manipulation. In such an
embodiment, pushing the stylet 114 distally collapses the braid
wire 109 (illustrated in the upper portion of FIG. 9), while
pulling the stylet 114 expands the braid wire 109 (illustrated in
the lower portion of FIG. 9).
[0296] In the embodiment illustrated in FIG. 9, the balloon 110 is
placed internal to the braid wire 109 such that the ends of the
balloon 110 are distal to the crimp section 111 and proximal to the
crimp 112. As previously discussed, the balloon 110 may comprise
silicone, but the balloon 110 can be of other materials previously
identified. The balloon 110 then uses an internal lumen and side
port (not shown) of the catheter stylet 114 for inflation and/or
deflation.
[0297] It should be noted that, in certain embodiments, the
silicone balloon 110 may expand axially and radially when inflated.
This may cause the balloon 110 to become "S" shaped for a set axial
length of tubing, thus causing the braid wire 109 to have
non-uniform tissue apposition with the HAS. In such embodiments, to
compensate for this configuration, the balloon 110 may be
pre-stretched axially just prior to anchoring on the catheter
tubing to the stylet component 114. The stretched balloon 110 may
then expand radially with little to no axial expansion, depending
on the amount of pre-stretch performed. The balloon 110 may also be
used to occlude the HAS to impair blood flow and to remove blood
from the braid portion of the catheter. This creates a static fluid
volume and advantageously provides for a more efficient heat
treatment. Also, the balloon 110 may promote braid apposition with
the HAS. In other embodiments, the balloon 110 is at least
partially expanded and contracted through expansion and compression
of the ends 111 and 112.
[0298] In certain embodiments, a temperature sensor 115 is attached
to the braid wire 109 along its axial length. For example, the
sensor 115 may be used for temperature control during the
application of energy. Although the sensor 115 is shown attached
near the proximal end of the braid wire 109, the sensor 115 may be
located along other portions of the braid wire 109. In other
embodiments, more than one sensor 115 may be used.
[0299] In another embodiment, the balloon 110 is separate from the
braid device 109. For example, the balloon 1 10 may fit within the
lumen of the braid device 109, and the tips of both the braid
device 109 and the balloon 1 10 may connect and anchor to each
other. For example, the anchor mechanism may include a set of male
and female threads appropriately sized. Alternatively, the tips may
be anchored together by use of axially aligned holes in both tips,
through which a wire is placed and tied off. Alternatively, the
tips may be designed with a spring ball detent to anchor the tips
together. Alternatively, magnetic or electromagnetic materials of
opposite polarity may be used to align the tips and hold them
together.
[0300] Expandable Loop
[0301] Another embodiment of a resistive element system 118, which
is shown in FIG. 10A, utilizes at least one expandable loop 119
that emanates from a side of the main catheter shaft 120. In
particular, one end of the loop 119 is anchored to the catheter
shaft 120. The other end of the loop 119 passes through an opening
122 in a sidewall of the catheter shaft 120 and runs through the
catheter lumen to a handle at the proximal end of the catheter
shaft 120. In certain embodiments, this second end of the loop 119
functions as a stylet in order to manipulate the shape and/or size
of the loop 119.
[0302] In one embodiment, the loop 119 comprises a wire 123 that
coils around the main catheter body 120 with spaced attachment
points (such as, for example, by entering into and exiting from
segments of a lumen within the main catheter body 120). In such an
embodiment, by advancing the wire 123 the coils extend beyond the
main catheter body 120 as circular coils extending substantially
perpendicular to the axis of the main catheter body 120. In certain
embodiments, the wire 123 is generally circular in cross-section.
In one embodiment, the loop 119 is pre-shaped in order to extend
outward toward and/or to contact the calls of a HAS. Alternatively,
the wire 123 that forms the actual exposed loop 119 may be flat,
rectangular, ovular, or have other geometrical cross sections. In
one embodiment, rotating a stylet handle end of the loop 119
manipulates, or twists, the loop 119 toward or away from the
catheter shaft 120.
[0303] In certain embodiments, the loop 109 may comprise a
resistive element similar to the element 14 of FIG. 1. For example
the loop 109 may comprise a resistive element coil. In addition,
each loop 109 may have a temperature sensor on the resistive
element for use in temperature controlled energy delivery. In other
embodiments, each resistive element may be covered with a sleeve.
For example, the sleeve material may comprise PET, TEFLON.RTM.,
polyimide or other like material.
[0304] Wavy Expandable Length
[0305] Another embodiment of a resistive element system 126 is
shown in FIG. 10B and utilizes at least one expandable formed set
of bends. A main spline 127, as shown in more detail in FIG. 10D,
forms a backbone and is, in certain embodiments, made of
NITINOL.RTM.. In other embodiments, the spline 127 is made of other
nickel-based spring alloys, 17-7 stainless-steel, Carpenter 455
type stainless-steel, or beryllium copper or similar materials. As
shown in FIG. 10D, the illustrated spline 127 is wound with a
resistive wire 130, an example of which is discussed in more detail
with respect to FIG. 4. In certain embodiment, the device 126
illustrated in FIG. 10A may also include a temperature sensor.
Because the illustrated spline 127 slides into a tube 131, the
spline 127 may comprise an outer sleeve 132 made of TEFLON.RTM., or
other like material, for reduced frictional force.
[0306] In one embodiment, the spline 127 is straightened by
withdrawing it proximally into the tube 131. For example, the tube
131 may comprise an inner liner 134, which extends out of the tube
end and is formed into an outer lip 133, which is shown in more
detail in FIG. 10C. In addition, FIGS. 10A-10C show the wind of the
spline 127 as two-dimensional. However, a skilled artisan will
recognize from the disclosure herein that the spline 127 may also
comprise various three-dimensional shapes, such as for example, a
helical wind. The particular shape may be used to improve contact
of the heating element to the wall of a HAS during treatment.
[0307] Expandable Floating Ribbon
[0308] FIG. 11 illustrates another embodiment of a resistive
element device 135 using at least one expandable resistive element.
In the illustrated embodiment, pre-shaped splines 136 act as
individual resistive heating elements. The set of splines 136 is
attached radially about a catheter shaft 137. In certain
embodiments, the spline set 136 has at least one expandable
resistive element section. In FIG. 11, the illustrated device 135
has two expandable sections. As shown, the spline set 136 is
anchored at a midpoint 138, which preferably does not substantially
expand. A tip 139 and proximal end attached to the shaft 137 also
preferably do not substantially expand.
[0309] In certain embodiments, the device 135 is designed to
collapse by use of an outer sheath (not shown), which in FIG. 11
would be in a retracted position. For example, the sheath may be
used to help place the device 135 in the HAS and to help remove the
device 135 after treatment. One intent of the self-adjusting
splines 136 is to allow for expansion such that the splines 136 are
in apposition to tissue and adjust to any axial bends or curves in
the subject HAS. As the HAS is heated during treatment, the lumen
of the structure constricts and/or shrinks, and the spline set 136
adjusts and collapses concurrently with the lumen. This same
characteristic also gives the device 135 of FIG. 11 versatility, as
it is able to accommodate varying sizes of hollow anatomical
structures.
[0310] Alternatively, the device 135 comprises a stylet wire
similar to the braid device of FIG. 9 in order to collapse and
expand the pre-shaped splines. In such an embodiment, the splines
may be manually collapsed during treatment in order to follow the
occlusion of the HAS.
[0311] In certain embodiments, each spline 136 is made of a
resistive material as previously discussed. Alternately, at least
one spline 136 may have a resistive coil wire wrapped around it, as
is previously described. In certain embodiments, a temperature
sensor may also be attached to at least one spline 136 for
temperature controlled energy delivery.
[0312] In certain embodiments, one long expandable section makes up
the spline set 136. To support the length during treatment, a
balloon may be placed inside the spline set 136. For example, this
balloon may use an internal lumen of the catheter (not shown) for
inflation and deflation. Alternatively, as described for the braid
device, the balloon may be a separate device inserted into the long
expandable spline set 136.
[0313] As discussed previously with respect to the fixed diameter
resistive element, the spline resistive elements 136, when
individually wired for power, may also be used advantageously in
conjunction with a multiplexing process. Such an embodiment allows
for the sequential or "cascading" heating of specific resistive
element subsets of the spline set 136. Such multiplexing may
involve energizing at least one spline 136 for a specific dwell
time and then cascading or moving to the next adjacent spline(s)
136 until the end spline is reached. The cycle is then repeated
until the complete treatment time is reached.
[0314] Super Elastic Expanding Ribbon
[0315] FIGS. 12A-12C illustrate an embodiment of a treatment
catheter with a helical coil resistive element 140. For example,
the coil resistive element 140 may be manipulated from a collapsed
or small-diameter coil tightly wrapped around the circumference of
a catheter shaft (see FIG. 12A) into an expanded, large diameter
coil (see FIG. 12C). In one embodiment, the coil 140 comprises a
resistive material as discussed earlier. The expanded coil 140 may
also be in apposition with the wall of a HAS. In one embodiment,
the catheter shaft is made of two concentric tubes or shafts, 142
and 143. In such embodiments, the proximal tube 142 may be slightly
larger in diameter to fit over the distal tube 143. The distal tube
143 is capable of rotating about the catheter tube axis relative to
the proximal tube 142. In the illustrated embodiment, clockwise
rotation of the distal tube 143 expands the resistive element coil
140 (as shown in FIG. 12C), and counter-clockwise rotation of the
distal tube 143 collapses the resistive element coil 140 (as shown
in FIG. 12A).
[0316] FIG. 12A shows the initial collapsed position of the device
when, for example, the catheter is initially placed in the HAS.
FIG. 12B shows a mid-range of the radial expanding resistive
element coil 140, and FIG. 12C shows a final state of the device
completely expanded. In certain embodiments, the coil 140 is
adjusted to eliminate the inter coil spacing by being pushed
distally. The steps described may also be reversed to collapse the
device for new placement or for removal.
[0317] In one embodiment, for the distal tube 143 to rotate and
move axially, the distal tube 143 is connected to a torquable
stylet wire (not shown). This stylet may run internal to the
proximal tube 142 and/or the distal tube 143 and may be accessible
at a catheter handle. In one embodiment, the handle also locks the
stylet in position in order to maintain the resistive element in a
collapsed and/or expanded state.
[0318] In certain embodiments, the resistive element 140 is made of
NITINOL.RTM. having a shape memory property that returns the
resistive element 140 to its pre-shaped expanded coil form upon
heating. In such an embodiment, one end of the coil 140 may be
tethered to the catheter, such as for example, the proximal end.
The expanded coil 140 may also "auto collapse" as the HAS shrinks
and/or constricts during the treatment. In another embodiment, a
sheath is used to retrieve the coil 140 after treatment.
[0319] FIGS. 13A and 13B show an embodiment of an expandable flat
strip resistive element device 145 that includes radially expanding
coiled strips 146. As shown, the device 145 has at least one strip
resistive element 146. FIG. 13A shows the resistive element 146
collapsed (i.e., coiled tightly). By rotating a first stylet
component 147 in a clockwise direction, the illustrated resistive
element 146 winds up into a collapsed coil. Likewise, by rotating
the stylet wire 147 in a counter-clockwise direction, the
illustrated coil 146 expands and adjusts to be in apposition with a
wall of a HAS. A secondary stylet 148 is shown as a stationary
component (e.g., not rotatable). In other embodiments, the stylet
148 may also comprise a catheter tubing or component that attaches
to the end of the resistive element 146 and/or that is
rotatable.
[0320] FIG. 13B is an example of a 4-resistive element strip
version of the device 145 of FIG. 13A and is illustrated in a flat,
expanded position. In such an embodiment, the resistive element
strips 146 comprise resistive material as previously discussed.
Stylets 147 and 148 connect to the resistive element strips 146,
and the strips 146 heat up when energized. Alternatively, the
strips 146 may have resistive wire wrapped around them to form
coil-type resistive elements.
[0321] In certain embodiments, one or more temperature sensors, as
previously described, may also be attached to at least one strip
146 for temperature-controlled energy delivery. In addition, strip
resistive elements 146 may be used in conjunction with the
multiplexing process to heat specific subsets of the group of
resistive elements 146.
[0322] In an alternative embodiment, a resistive heating device can
be configured such that the resistive heating element also acts as
a resistance temperature device (RTD). Certain metals exhibit
predictably varying electrical resistance properties at varying
temperatures. If this relationship is known for a given resistive
heating element, a temperature of the element can be determined by
measuring an electrical resistance across it. Such a system may
advantageously eliminate the need for additional thermocouples or
other temperature sensing devices and/or may provide an independent
sensing of temperature for high-temperature situations.
[0323] Indexing
[0324] In some embodiments, it is desirable to provide a heating
element configures to treat a relatively short lengths of a HAS at
successive intervals. Such an embodiment can be progressively moved
through the HAS in a series of discrete steps from a first position
to a final position in order to treat a desired length of the HAS.
The process of moving a heating element through a HAS in a series
of discrete steps during treatment is referred to herein as
"indexing."
[0325] A general indexing process may proceed by providing an
elongate catheter with a relatively short-length heating element at
a distal portion thereof. The heating element and/or catheter may
be inserted through an introducer sheath into a HAS, such as, for
example, a vein. The heating element is advanced to a distal-most
position, and power is then applied thereto. The temperature of the
subject heating element is allowed to ramp up or increase to a
desired temperature and remains in place for a desired dwell time.
Once the desired dwell time is reached (e.g., the treatment for the
section is completed), the heating element can be powered down, and
the element can be indexed proximally to a second position, at
which point at least one of the ramp up, dwell, power down, and
indexing procedures may be repeated.
[0326] FIGS. 14 through 30B illustrate embodiments of short-length
heating elements and indexing systems. It should also be noted that
the devices and structures discussed previously herein may also be
used in an indexing system. For exemplary purposes, several of the
following embodiments are described with reference to a coil-type
resistive element.
[0327] For example, FIG. 14 illustrates one embodiment of an
indexing HAS treatment system 200 comprising an elongate catheter
202 extending through an introducer sheath 204, which includes a
hub 206, and a heating element 208 located at the distal end of the
catheter shaft 205.
[0328] In certain embodiments, the heating element 208 is an
electrically resistive heating element, including but not limited
to any of those described elsewhere herein, such as any of the
embodiments of the resistive element 14 described herein. For
example, the heating element 208 may comprise a single, bifilar or
other electrically resistive wire. The heating element 208 can also
comprise multiple, separately operable heater sections (as in the
resistive element 70), to provide a heating element 208 which has
an adjustable active length, or an active region which is
adjustable in size. FIG. 14 further illustrates an embodiment of
the heating element 208 comprising a wire having tightly-wrapped
coils around a hollow, elongate structure. Thus, the embodiment of
FIG. 14 can include a heating element 208 in the form of a coil
similar to that shown in partial section in FIG. 4 above. In other
embodiments, the heating element 208 may comprise a loose, tight,
or variable-pitch coil wound around a solid or hollow elongate
structure. In other embodiments, the heating element 208 is
composed of an electrically-resistive tube that can reach and
maintain high temperatures (e.g., a solid-state heater).
[0329] In certain embodiments, the heating element 208 has a
substantially short axial length. For example, in certain
embodiments, the heating element 208 has a length of between
approximately one centimeter and approximately ten centimeters.
Such a length is believed to be particularly advantageous for
embodiments utilizing manual, external compression to treat a HAS.
In certain preferred embodiments, the length of the heating element
208 is between approximately three centimeters and approximately
seven centimeters.
[0330] In certain embodiments, the heating energy delivered by the
heating element 208 of the system 200 is less than 100 watts. In a
more preferred embodiment usable in an indexing process, the
heating energy delivered by the heating element 208 is between
approximately ten watts and forty watts.
[0331] In certain embodiments, in order to accurately index the
heating element 208, it is desirable to provide a means for
repeatedly moving (or facilitating accurate, repeated repositioning
of) the heating element 208 proximally within an HAS undergoing
treatment by a desired distance. In certain embodiments, this
desired distance is less than the overall length of the heating
element 208 so as to effectively re-treat regions that may receive
less heat energy as a result of an uneven heating profile along the
axial length of the heating element 208. It may also be desirable
to treat more than once a portion of an initial and/or final
treatment region of the HAS in order to arrange for start- and
endpoints of the indexing distances to correspond with catheter
shaft markings or to arrange that, after the full series of indexed
treatments, the final HAS treatment region is in substantial
alignment with the end of the introducer sheath 204. It may also be
desirable to treat more than once a complete treatment region or
regions of the HAS (e.g., for the case of saphenous vein ablation,
double-treating the segment nearest the saphenofemoral junction, in
the region nearest a large tributary vessel, or at an aneurismal
vein segment). In addition, in certain embodiments, the system 200
includes means for preventing the heating element 208 from being
powered up while it is within the introducer sheath 204.
[0332] In certain embodiments, as illustrated for example in FIG.
15A, the catheter shaft 205 may comprise a plurality of markings
211 along the axial length thereof in order to assist in visual
verification of indexing positions. Such markings 211
advantageously assist a user in positioning and indexing the
heating element of the catheter 202 during treatment. For example,
the user may determine from the markings 211 how far the heating
element should be retracted during a treatment interval.
[0333] In certain embodiments, the physician uses the markings 211
to manually and selectively move the catheter 202 within a HAS of a
patient. For example, the catheter 202 may have an associated
therapeutic or heating element at the end thereof that extends
approximately seven centimeters in length. In such an embodiment,
the markings 211 may be spaced apart at approximately 6.5
centimeter intervals. When treating the patient, the physician may
use the markings 211 to manually withdraw along the HAS the
catheter 211 at 6.5 centimeter intervals between successive
treatments of the HAS. Such a 6.5 cm movement can be performed by
proceeding from a first state in which a first shaft marking 211 is
aligned with a fixed reference point (e.g., the proximal edge of
the introducer sheath hub 206 or other datum as discussed in
further detail below), then moving the catheter shaft 205
proximally (or distally) to reach a second state in which a
proximally (or distally) adjacent second shaft marking 211 is
aligned with the fixed reference point. In other embodiments, and
as discussed in more detail below, a device may be used to
automatically withdraw the catheter at the predetermined intervals
indicated by the markings 211.
[0334] In certain embodiments, the location of a therapeutic energy
application device, such as a heating element, within the HAS may
be indicated by a visibility-enhancing element. The
visibility-enhancing elements may be located at one or both ends of
the therapeutic energy application device, or may be located along
some or all of the length of the therapeutic energy application
device.
[0335] In some embodiments, the visibility-enhancing element may
facilitate the unmediated visualization of the location of the
therapeutic energy application device using the naked eye, as for
example in the case of through-tissue illumination. For example,
FIG. 15B illustrates an embodiment of a catheter that may
incorporate one or more light emitters such as optical fibers such
that an illuminating spot appears at one or both ends of the
therapeutic energy application device through illumination holes
212. Alternatively, the light emitters may be configured to direct
light radially outward away from the longitudinal axis of the
elongate catheter shaft. In certain embodiments, such light
emitters may be spaced radially apart around the longitudinal axis
of the elongate catheter shaft. The illumination may be powered by
a light emitting diode (LED) and battery within the handle of the
catheter, by an external light source that may be separate or
included as part of the power generator for therapeutic heating, or
by any other device known in the art for generating light, whether
electrically, chemically, or by any other known principle.
[0336] In some embodiments, the visibility-enhancing element may
facilitate the visualization of the location of the therapeutic
energy application device mediated by a viewing system, as for
example in the case of the use of ultrasound or radiation-based
viewing systems. Visibility-enhancing elements for use with an
ultrasound viewing system include, for example, a portion of the
apparatus that is rendered highly reflective of ultrasound. This
can be accomplished by, for example, applying a surface treatment
to a portion of the apparatus, such as at or near the therapeutic
energy application device, such that the surface more readily traps
gas microbubbles, which reflect ultrasound. Alternatively, the
portion can be produced using a specialized coating, comprising a
smooth biocompatible polymer coating containing effervescent
agents, that has a microbubble-generating effect. An example of
such a coating is Phyz.TM. coating. In a further embodiment, one or
more gas bubble delivery ports may be provided at or near the
therapeutic energy application device, to provide greater contrast
when viewing with ultrasound. Alternatively, the
visibility-enhancing element may comprise one or more ultrasound
emitters, which may employ any structure known in the art.
Furthermore, visibility-enhancing elements for use with a
radiation-based viewing system include, for example, portions of
the apparatus that are relatively highly radiopaque. In one
embodiment, for example, a radiopaque element may be applied at or
near the therapeutic energy application device. The radiopaque
element may comprise a single, elongate element, such as a wire,
wrapped around the therapeutic energy application device
substantially continuously along the entire length of the
therapeutic energy application device. Alternatively, the
radiopaque element may comprise a coating, plating or film adhered
to the coil along its length. The radiopaque materials used for
this radiopaque element may comprise, for example, platinum, gold,
tantalum, or any other radiopaque material known in the art.
[0337] Furthermore, in one embodiment, the therapeutic energy
application device has a length greater than the width thereof. In
another embodiment, the therapeutic energy application device is a
closed circuit therapeutic energy application device. In another
embodiment, the therapeutic energy application device has a fixed
profile in a plane orthogonal to the longitudinal axis of the
therapeutic energy application device.
[0338] FIGS. 16A-16D depict one embodiment of the HAS treatment
system 200 and a method of its use to treat a vein, such as the
great saphenous vein (GSV) as depicted, near its junction with the
femoral vein (FV), at the sapheno-femoral junction (SFJ). In other
embodiments the system 200 can be used to treat other HASs, such as
other veins.
[0339] In certain embodiments, and as depicted in FIG. 16A, the
introducer sheath 204 is first inserted through the patient's skin
S and manipulated until the distal end of the sheath 204 is within
the lumen of the GSV, and the hub 206 remains outside the skin
surface. Once the sheath 204 is in place, the catheter 202 is
passed distally through the lumen of the sheath 204, and into the
GSV until the distal tip of the heating element 208 is positioned
at or near the SFJ, as shown in FIG. 16A. To facilitate insertion
of the catheter 202, in certain preferred embodiments, the
introducer sheath may have a minimum inner diameter of
approximately 2.33 millimeters (approximately seven French). The
position of the heating element 208 can be monitored or confirmed
using appropriate corporeal vision techniques, such as, for
example, ultrasonic imaging.
[0340] In the embodiment of FIGS. 16A-16D, the catheter shaft 205
is marked with first, second, third and fourth marking sections
214, 215, 216, 217, which are marked on the shaft 205 in any of the
arrangements set forth herein (e.g., alternate colored and/or
cross-hatched sections, or a series of tick marks spaced apart from
each other by the desired indexing distance, and/or geometrically
coded markers of alternating or varying shape) so as to make the
distal and proximal edges of each section 214, 215, 216, 217 easily
visible by the user. Thus, the user can observe the marking
section(s) to determine the relative position of the heating
element 208 within a HAS and/or with respect to the introducer
sheath 204. Preferably, the axial length of each section 214, 215,
216, 217 is approximately equal to the length of the heating
element 208, less any intended overlap distance between treatments.
In one preferred embodiment, the heating element 208 is seven
centimeters in length and each section 214, 215, 216, 217 is 6.5 cm
in length. The shaft 205 can be varied in length so as to include
more or fewer sections than the four depicted in FIGS. 16A-16D.
[0341] Generally, the heating element 208 (or an energy coupling
surface thereof) can have a suitable axial length and the length of
each section 214, 215, 216, 217 can be the heating element length
(or energy coupling surface length) less a decrement which can be
between 1% and 15% of the heating element length. This decrement
corresponds to a treatment overlap length as explained above. In
some embodiments, the heating element 208 can be between 2 and 10
centimeters in length, and the decrement can be between 0.1 and 1.5
centimeters. In still other embodiments, the length of each section
214, 215, 216, 217 can be slightly greater than the length of the
heating element 208.
[0342] In addition, in certain embodiments the length of the
heating element 208 is greater than the width thereof. (The width
of the heating element is the greatest dimension (e.g., the
diameter) of a cross-section of the heating element 208 taken
orthogonal to the longitudinal axis.) The length of the heating
element can be, in various embodiments, at least ten times the
width thereof, or at least fifteen times the width thereof.
[0343] The sheath 204 depicted in FIGS. 16A-16D includes a
longitudinally adjustable datum device or reference point indicator
218, which can be employed to provide a fixed reference for the
position of the shaft 205 and heating element 208 as discussed in
further detail below. Preferably connected to the proximal end of
the hub 206, the reference point indicator 218 comprises a
reference point 218a which is longitudinally moveable relative to
the hub 206 via an adjustable section 218b, which in the depicted
embodiment comprises an accordion section. Alternatively, the
adjustable section 218b can comprise a threaded cylinder or other
threaded member (not shown) which engages threads on the hub 206 to
facilitate longitudinal movement of the reference point 218a via
rotation of the adjustable section 218b relative to the hub 206.
However implemented, the adjustable section 218b is preferably
transparent, or includes a transparent window or an opening to
permit the user to see the portion of the catheter shaft 205 that
passes through the adjustable section 218b proximal of the hub
206.
[0344] With resumed reference to the method depicted in FIGS.
16A-16D, once the catheter 202 is in place in the GSV with the
heating element 208 near the SFJ (FIG. 16A), the user adjusts the
reference point indicator 218 by aligning the reference point 218a
with the proximal edge of the first marking section 214. In FIG.
16B, this is depicted as a proximal movement of the reference point
218a relative to the catheter shaft 205, accomplished by
longitudinally stretching or extending the accordion section and
then fixing the reference point 218a in the correct position by any
suitable means. Where the adjustable section 218b comprises a
threaded cylinder or the like, the cylinder is rotated until the
reference point 218a reaches the correct position, where it is
fixed in position. Alternatively, the user may partially withdraw
the introducer sheath 204 proximally from the GSV until the sheath
hub 206 or reference point indicator 218 is aligned with an
indexing marking (e.g. an indexing marking 219a), shaft tick mark,
marking segment, etc.
[0345] Preferably, after alignment of the reference point indicator
218 or the proximal end of the sheath 204 with an indexing marking,
etc. as discussed above, the user secures the sheath 204 with
respect to the GSV, so that the sheath end or reference point
indicator 218 can serve as a fixed reference point for indexing of
the catheter 202. This can be accomplished by, for example,
securing the sheath 204 to the patient, which can comprise suturing
or taping the sheath to the skin of the patient near the insertion
site of the sheath.
[0346] The system 200 is now ready for use in treating the GSV as
follows. FIG. 16B shows the heating element 208 in an initial
treatment position near the SFJ. At this point, the user activates
the heating element 208 by cycling through the steps of powering up
the heating element 208, dwelling at a power or temperature state
(or series of states), and then powering down the heating element
208. Having completed the treatment cycle for an initial, distal
(e.g., limb-proximal) section of the GSV, the user may perform a
second treatment closest to the SFJ. The user then moves the
catheter shaft 205 and heating element 208 proximally by the
desired indexing distance (e.g., 6.5 cm), by moving the shaft
proximally until the proximal edge of the second marking section
(e.g., to the next tick mark) 215 is aligned with the reference
point 218a (FIG. 16C). The user then repeats the treatment cycle
with the heating element 208. Following the treatment cycle, the
user again moves the shaft 205 and heating element 208 proximally
by the indexing distance, pulling the shaft proximally until the
proximal edge of the third marking section 216 (e.g., to the next
tick mark) is aligned with the reference point 218a.
[0347] This sequence of treatment cycle-index-treatment cycle is
repeated until the desired length of the GSV (or other vein or HAS)
has been treated, at which point the catheter 202 and introducer
sheath 204 are removed from the treatment area.
[0348] In certain embodiments, the fourth or distal-most marking
section 217 indicates a "stop treatment zone" or a "last treatment
zone," which can be employed to prevent the heating element 208
from being withdrawn too far (e.g., into the introducer sheath
204). For example, the fourth marking section 217 may comprise a
band of a solid or patterned color such as red, yellow or other
color or pattern that contrasts with the base color or pattern of
the catheter shaft 205.
[0349] Furthermore, when implemented as a stop-treatment marker,
the fourth or distal-most marking section 217 preferably has a
length that is substantially equal to the length of the introducer
sheath 204 (rather than having a length equal to the desired
indexing distance as discussed above), which generally includes,
but is not limited to, the following lengths: five, seven and
eleven centimeters. In certain embodiments, a plurality of distinct
stop-treatment markers may be used on a single shaft 205, the
plurality of stop-treatment markers corresponding to the various
lengths of introducer sheaths usable with the catheter 202. When
employed, the stop-treatment marker is preferably distinct from the
indexing markers. For example, the stop-treatment marker can be of
a type, shape, length, color, pattern and/or configuration that
differs from that employed for the indexing markers.
[0350] Thus, when used as a stop-treatment marker, if the proximal
edge of the fourth or distal-most marking section 217 is pulled out
of the proximal end of the introducer sheath 204 (see FIG. 16D),
the user will know that the heating element 208 is positioned
within the introducer sheath 204. The user can then push the
catheter 202 distally until the stop-treatment marker is positioned
within the hub of the introducer sheath 204, thus avoiding damage
to the sheath 204 and/or heating element 208.
[0351] Where the catheter 202 employs a heating element 208 with an
adjustable active length or adjustable active region as discussed
above, the heating element can be operated with a shortened or
reduced active length or region to facilitate treating a "partial"
length of the HAS, which is shorter than the entire heating element
length. This is useful for treating a relatively short portion of
the HAS at the beginning and/or end of the treatment process.
[0352] In certain embodiments, the indexing process described with
reference to FIGS. 16A-16D allows a user to treat selected segments
of a HAS for successive periods of time. Furthermore, the markings
214-217 and the reference point indicator 218 of the introducer
sheath 204 advantageously allow the user to determine the relative
position of the heating element 208 within the HAS and/or with
respect to the introducer sheath 204 through a means external to
the body of the patient.
[0353] Although described with reference to particular embodiments,
other types or forms of markings may be used with embodiments of
the HAS indexing system described herein. For example, in certain
embodiments, it may be desirable to provide a unique marker to
indicate a final, proximal-most, indexed position so that the
corresponding heating element remains spaced from the introducer
sheath by a sufficient distance to prevent the sheath from
melting.
[0354] As mentioned above, the introducer sheath 204 advantageously
includes a longitudinally adjustable reference marker 218. The
sheath 204 has a lumen which extends from the distal tip of the
sheath (shown inserted within the GSV in FIG. 16A) to the proximal
edge of the hub 206. The sheath lumen extends generally along a
luminal axis in a distal-to-proximal direction, and a portion of
the catheter shaft 205 is depicted as passing through the sheath
lumen and along the luminal axis in FIGS. 16A-16D. As seen in FIGS.
16A-16B, the position of the reference marker 218a is
longitudinally adjustable relative to the sheath 204 in the
distal-to-proximal direction, along the luminal axis.
[0355] In one embodiment, the reference marker 218 is removably
coupled to the proximal end of the sheath 204, so that it can be
easily removed or attached for use as the surgical situation
demands. In further embodiments, any of the various reference
markers 218 described herein can be connected (either in a
removable fashion, or substantially permanently such as by integral
formation) to the proximal end of any of the sheaths 223a, 223b,
223c shown in FIG. 16H, or to the proximal end of any other
suitable sheath type. Advantageously, the longitudinally adjustable
nature of the reference marker 218 facilitates alignment of the
reference marker with one of the indexing markings on the shaft 205
without need for movement of the shaft 205 relative to the sheath
(or vice versa).
[0356] FIG. 16E illustrates another embodiment of a catheter 202'
usable to treat a HAS, according to certain embodiments. As shown,
the catheter 202' includes a set of markings to inform the user
when a heating element, or other therapeutic element, of the
catheter 202' is approaching an introducer sheath. In certain
embodiments, such markings advantageously prevent a user from
drawing the heating element into the introducer sheath, which may
cause damage (e.g., melting) to the sheath.
[0357] As shown, the catheter 202' includes indexing markings 219a
usable to successively treat predetermined lengths of a HAS, as is
described in more detail with reference to FIGS. 16A-16D. For
instance, the indexing markings 219a may correspond to the
locations of the edges of the first, second, third and fourth
marking sections 214, 215, 216, 217 of the catheter shaft 205
illustrated in FIGS. 16A-16D. In certain embodiments, the indexing
markings 219a are of a width easily visible by a user, such as for
example, approximately 0.2 centimeters.
[0358] In certain embodiments, the distance "a" between each of the
indexing markings 219a is approximately 6.5 centimeters. In such
embodiments, the length of the therapeutic element may extend
further than 6.5 centimeters, such as approximately seven
centimeters, such that there exists a slight overlap between
successive treatment portions. In certain embodiments, the catheter
202' may include approximately sixteen indexing markings 219a. In
yet other embodiments, other numbers of, or distances between,
indexing markings 219a may be used as appropriate. For instance, a
catheter with a shorter therapeutic section may utilize a shorter
distance between indexing markings.
[0359] Generally, in the catheter 202' of FIG. 16E the therapeutic
element or heating element (or an energy coupling surface thereof)
can have a suitable axial length and the distance "a" between each
of the indexing markings 219a can be the heating element length (or
energy coupling surface length) less a decrement which can be
between 1% and 15% of the heating element length. This decrement
corresponds to the desired treatment overlap length as explained
above. In some embodiments, the heating element can be between 2
and 10 centimeters in length, and the decrement can be between 0.1
and 1.5 centimeters. In still other embodiments, the distance "a"
between each of the indexing markings 219a can be slightly greater
than the length of the therapeutic element.
[0360] In addition, in certain embodiments the length of the
therapeutic element or heating element of the catheter 202' is
greater than the width thereof. (The width of the heating element
is the greatest dimension (e.g. the diameter) of a cross-section of
the heating element taken orthogonal to the longitudinal axis.) The
length of the heating element can be, in various embodiments, at
least ten times the width thereof, or at least fifteen times the
width thereof.
[0361] The illustrated catheter 202' further includes a warning
section 220 and at least one warning marking 219b that inform a
user that the associated therapeutic element is approaching the
introducer sheath through which the catheter 202' is inserted. For
instance, the warning section 220 may identify the position of the
catheter 202' relative to an introducer sheath during treatment of
a final section of the HAS. In certain embodiments, this final
section is the final full-length section (e.g., seven centimeters)
treated with the therapeutic section of the catheter 202'.
[0362] In certain embodiments, the warning section 220 includes a
distinct color and/or pattern that distinguishes the section 220
from other portions of the catheter 202'. For instance, the warning
section 220 may include a red or yellow color. In certain
embodiments, the warning section 220 may also be substantially the
same length as the marking sections identified by the indexing
markings 219a. For instance, a distance "b" may be approximately
6.5 centimeters.
[0363] The at least one warning marking 219b advantageously
identifies the furthest point(s) to which the catheter 202' may be
drawn without entering the introducer sheath. In particular, the
illustrated catheter 202' includes three warning markings 219b that
correspond to three different sized introducer sheaths (e.g., a
seven-centimeter sheath, an eleven-centimeter sheath and a
fifteen-centimeter sheath). These multiple markings allow for
flexibility and/or adaptability in use of the catheter 202' because
the user may appropriately manipulate and use the catheter 202'
with different-length sheaths.
[0364] In use, the warning markings 219b, in combination with the
warning section 220, inform a user when to stop drawing the
catheter 202' through the introducer. For instance, the user may
utilize the indexing markings 219a as he/she treats successive
portions of a HAS. During this treatment process, the user
incrementally draws the catheter 202' out of the associated
introducer. When the warning section 220 becomes visible, such as
when the warning section 220 as been fully drawn out of the
introducer (e.g., such that a distal end of the warning section is
substantially flush with an introducer hub), the user is informed
that the therapeutic element of the catheter 202' is near the
introducer sheath.
[0365] Subsequent warning markings 219b further alert the user as
to the final position(s) of the catheter 202' before the
therapeutic element enters the introducer sheath. As shown, each of
the warning markings 219b includes an associated alphanumeric
marking that corresponds to a certain-length introducer sheath. For
instance, the three illustrated warning markings 219b include the
numbers "7," "11" and "15," which correspond to, respectively,
warning markings for a seven-centimeter introducer sheath, an
eleven-centimeter introducer sheath and a fifteen-centimeter
introducer sheath.
[0366] For example, as shown, the warning markings 219b include a
first warning marking positioned a distance "d" from a distal end
of the catheter 202' and includes the alphanumeric character "7."
In certain embodiments, the distance "d" is preferably at least as
long as the sum of the length of the therapeutic section and the
length of the particular introducer sheath. For example, the
catheter 202' includes a therapeutic element with its proximal end
identified by an element marker 219c and having a length "c" of
approximately eight centimeters, which may include a one-centimeter
terminal portion at the distal end of the catheter 202' that is not
used for therapeutic treatment. In such an embodiment, the distance
"d" preferably would be at least fifteen centimeters in length.
Furthermore, in certain embodiments, the diameter of the
therapeutic element may be approximately 2.25 millimeters.
[0367] Moreover, the catheter 202' includes a second warning
marking positioned a distance "e" from the end of the catheter 202'
and including an alphanumeric character "11." The catheter 202'
also includes a third warning marking positioned a distance "f"
from the end of the catheter 202' including an alphanumeric
character "15." In embodiments wherein the catheter 202' includes a
therapeutic element with a length of approximately seven
centimeters, plus a one-centimeter terminal portion, the distance
"e" is at least nineteen centimeters, and the distance "f" is at
least twenty-three centimeters.
[0368] In certain embodiments, the catheter 202' has an overall
insertable length "g" of approximately 100 centimeters. In yet
other, embodiments, the catheter 202' may be shorter or longer as
appropriate. For example, the catheter 202' may have an overall
insertable length of approximately 60 centimeters.
[0369] In certain embodiments, the catheter 202' comprises a
flexible shaft and an inner lumen extending therethrough. For
instance, the lumen may be utilized for flushing the catheter 202'
prior to insertion of the catheter 202' into the patient and/or for
optional use of a guidewire to aid in navigation of the catheter
202' through the patient's venous anatomy.
[0370] Although FIG. 16E depicts one embodiment of the catheter
202', other embodiments may include fewer than or more than three
warning markings. For instance, another embodiment of the catheter
may include only warning markings corresponding to two introducer
sheath lengths, such as, for example, seven centimeters and,
preferably, eleven centimeters.
[0371] FIG. 16F illustrates a magnified view of a portion of the
catheter 202' depicted in FIG. 16E. In particular, FIG. 16F
illustrates the portion of the catheter 202' having the element
marker 219c, the three warning markers 219b and a portion of the
warning section 220.
[0372] FIG. 16G illustrates another embodiment of a catheter 202''
usable to treat a HAS, according to certain embodiments. Similar to
the catheter 202' of FIG. 16E, the catheter 202'' includes indexing
markings 219a, the warning section 220, warning markings 219b and a
therapeutic element 208. For example, in certain embodiments, the
therapeutic element 208 may comprise a heating element, such as a
resistive heating element.
[0373] FIG. 16H illustrates three different-sized introducers that
are usable in embodiments for treating a HAS. As shown, a first
introducer 223a includes an introducer sheath 231a coupled to a
fluid conduit 233a through an introducer hub 235a. In certain
embodiments, the introducer sheath 231a is inserted through the
patient's skin. A treatment catheter is then inserted into the
introducer hub 235a and through the introducer sheath 231a into a
HAS of the patient, such as a vein. The fluid conduit 233a further
allows for the insertion and/or removal of fluids, through the
introducer sheath 231 a, into and/or from the HAS. In certain
embodiments, the introducer sheath 231 a has a length of
approximately fifteen centimeters.
[0374] As further illustrated in FIG. 16H, a second introducer 223b
includes an introducer sheath 231b coupled to a fluid conduit 233b
through an introducer hub 235b. In certain embodiments, the
introducer sheath 231b has a length of approximately eleven
centimeters. A third introducer 223c includes an introducer sheath
231c coupled to a fluid conduit 233c through an introducer hub
235c. In certain embodiments, the introducer sheath 231c has a
length of approximately seven centimeters.
[0375] FIGS. 17A and 17B illustrate additional catheter shaft
markings usable for performing an indexed treatment process, such
as (but not limited to) the process depicted in FIGS. 16A-16D. FIG.
17A illustrates a catheter having regularly-spaced, alternating
colored and/or alternating light/dark lines that correspond to
desired indexing locations and/or distances. Such alternating
markers advantageously simplify the indexing process by removing
any need for counting individual centimeter-spaced markers on the
shaft. Furthermore, the alternating characteristics (e.g., color,
pattern) of the markings helps prevent repeated treatment of the
same area.
[0376] As shown, the catheter has a first set of markings 221 that
alternates with a second set of markings 222 along the length of
the catheter shaft. As shown in FIG. 17B, the marks may alternate
between red and white colors. The alternating markings may also
include reference symbols, numbers, letters such as "A" and "B," as
shown in FIG. 17A, or other marks in order to further distinguish
any given indexing position from the adjacent indexing
position(s).
[0377] As discussed above, the markings on the catheter shaft 202
of FIGS. 17A-17B may be arranged such that the index distances
defined between consecutive index step marks are actually shorter
than the length of the corresponding heating element. Again, this
encourages intentional overlapping of indexed treatments. For
example, for a heating element length of approximately seven
centimeters, the shaft markers 221, 222 (e.g., the distance between
consecutive A-A or B-B shaft marks) can be arranged to indicate a
6.5 centimeter index step, which may create a substantially
consistent 0.5 centimeter treatment overlap. Such an embodiment may
be particularly advantageous when the heating profile is not
consistent across the heating element (e.g., a lower temperature at
the outside edges of the heating element in comparison to the
temperature of a middle portion of a heating element).
[0378] Similar to the embodiments discussed above, the catheters of
FIGS. 17A-17B are used by being placed within a HAS at a desired
position for an initial treatment. When the initial treatment is
about to start, the physician or other user notes which catheter
shaft marking (e.g., which letter or color segment) is adjacent to
the proximal edge of the hub of the introducer sheath (or aligned
with whichever reference point or datum device is employed). If the
initial adjacent/aligned shaft marker segment is of a first type
(e.g., the mark 221 having the letter "A" with reference to FIG.
17A) then the start of the index step for the second treatment is
at the start of the next mark of the same type (e.g., the mark 221
having the letter "A" with reference to FIG. 17A) on the catheter.
This arrangement enables the physician to retract the heating
element of the catheter proximally by the desired indexing
distance, by moving the catheter until the opposing type of mark is
aligned with the hub edge or reference point. Alternatively, the
treatment process is started with "B" and each successive treatment
is indexed to the next "B" marker.
[0379] Where the proximal edge of the introducer sheath hub is
employed as the reference point for positioning and moving the
catheter, and if upon initial catheter placement in a HAS only a
partial length of a segment marked on the shaft initially extends
proximally out of the hub (similar to the situation in FIG. 16A,
but without the reference point indicator 218), then the physician
can simply perform a partial-length index step after the initial
treatment. In other words, the physician performs a first treatment
cycle with the heating element and catheter in its initial
placement in the HAS, and then moves the catheter proximally by a
partial index distance, until the proximal edge of the next
adjacent marked shaft segment is aligned with the proximal edge of
the introducer sheath. The usual treatment then proceeds, with one
or more "full-segment" treatments.
[0380] Alternatively, to address such a situation, the intervals
between the alternating shaft markers (e.g., markers 221 and 222,
or the distance between consecutive A-B shaft marks) may have a
length equal to approximately half of the desired index length in
order to reduce the length of a double-treated section, thereby
expediting the overall treatment process. With markers so arranged,
the first catheter movement stops at the first shaft marker
encountered, and subsequent catheter movements are a full index
distance in length proceeding to the next shaft marker of the same
type.
[0381] Still another way to address the "partial-segment" issue is
the use of an adjustable datum device, as described in more detail
above with respect to the reference point indicator 218 of FIGS.
16A-16D, and below with respect to FIGS. 19 and 20. These devices
may be used to designate an initial datum point or reference point
such that the second treatment is a full index distance from the
initial treatment (in other words, such that the catheter and
heating element move a full index distance between the initial
treatment and the second treatment). Nonetheless, as mentioned
above, a double treatment can be performed at the beginning and/or
at the end of the treatment procedure (e.g., during the initial
and/or final treatment interval) if it is determined that such a
double-treatment would have a beneficial effect on the overall HAS
treatment results.
[0382] FIG. 18A illustrates another embodiment of an indexing
system including a catheter 224 with regularly-spaced, numbered
marks that, when the catheter 224 is in use, correspond to indexing
locations and/or distances. The catheter 224 includes a heating
element 226 at the distal end of the catheter 224 and a sleeve 229
usable to identify the current indexing position. The illustrated
catheter 224 advantageously includes a shaft marked with numerical
values for use during the indexing process. For example, the
numerical values may correspond to the length of the catheter 224
portion extending within the HAS or may correspond to the distance
of (the proximal end of) the heating element 226 from (the distal
end of) the introducer sheath. In yet other embodiments, the
numerical values may correspond to the total length of the treated
portion of the HAS.
[0383] As further illustrated in FIG. 18A, the catheter 224 may
comprise major (e.g., five-centimeter-increment) markings 227 and
228 that include numerical values that increase proximally along
the catheter shaft 224. Between these major markings 227 and 228
there are additional shaft marks that comprise a repeated group of
the numbers (e.g., 1, 2, 3 and 4), letters (e.g., A, B, C and D)
and/or shapes (e.g., triangles, circles, diamonds and squares) to
designate lengths in between (or otherwise smaller than the
distance between) the major markings 227 and 228.
[0384] In some embodiments, different combinations or sets of
numerical markings may be used depending on the particular
treatment parameters (e.g., heat, time duration, length of HAS
treatment portion, and the like). In yet other embodiments, the
catheter 224 may comprise more than one movable position-indicating
sleeve 229. For example, a first reference marker may be used to
indicate the current position of the heating element 226, and a
second reference marker may be used to indicate how far the
catheter 224 should be re-inserted during a treatment process.
[0385] In certain embodiments, the position-indicating sleeve 229
is movable (e.g., slidable) along the shaft of the catheter 224.
For example, during a treatment process, a user may slide the
position-indicating sleeve 229 to the edge of a sheath in order to
highlight the desired current numerical value.
[0386] In certain embodiments, the shaft markings of HAS indexing
catheters as described herein are spaced at repeated intervals,
such as for instance one centimeter. In such embodiments, the major
increments (such as five centimeters) can have numbers that
increase proximally along the shaft. In use, the initial two
treatment locations within the HAS may overlap by as much as nearly
the full length of the catheter's heating element. In certain
embodiments, the increments marked on the catheter shaft may be in
fractional dimensions. For example, in certain embodiments using a
seven centimeter heating element, the increments marked on the
catheter shaft may be approximately 6.5 centimeters in length.
[0387] As shown in FIG. 18B, the distal-most position-indicating
sleeve 229 may be placed against an introducer sheath hub 225 to
highlight the current shaft marking-number for indexing. In such an
embodiment, if the treatment process is interrupted, the
position-indicating sleeve 229 records catheter position
information such that the physician can resume the treatment
process with the heating element in the correct position. In
certain embodiments, the sleeve 229 also is capable of remaining in
a selectively-fixed position (e.g., due to a friction fit) even
when the catheter 224 is temporarily removed from the introducer
sheath hub 225. In such embodiments, the physician is able to
advantageously continue a treatment process when returning or
replacing the catheter 224 into the introducer sheath hub 225. With
reference to FIG. 18B, a return of the catheter 224 having the
sleeve 229 highlighting the number "2" indicates that the next
treatment step is the next identical proximal marker (i.e., the
number "2" mark (obscured from view in the figure as it is covered
by the sheath) between major markings 227 and 228).
[0388] Each of the embodiments depicted in FIGS. 19 and 20
comprises a movable datum device or reference point indicator
usable for establishing a starting position for a first treatment,
or otherwise provide a fixed reference point for tracking the
position and movement of the catheter and heating element. FIG. 19
illustrates one embodiment of a datum device 230 coupled to an
introducer sheath hub 232 that serves as an attachment point to a
catheter 234. As shown, the datum device 230 includes a sleeve, or
body, 236 that includes a slot 238 running in an axial direction
such that the ends of the slot 238 do not extend beyond the length
of the sleeve 236. A pointer 240 is slidably positioned within the
illustrated slot 238. In certain embodiments, the pointer 240 is
advantageously mounted within the slot 238 such that there is
substantial resistance to sliding, so that the pointer 240 can
substantially maintain its position as a reference marker. In
certain embodiments, the sleeve or body 238 may comprise a
transparent or semi-transparent material, or may include portions
removed therefrom, such that index markings 242 on the catheter 234
can be seen as they approach the pointer 240.
[0389] In certain embodiments, prior to a first heating treatment,
the datum device 230 is adjusted to point at the nearest catheter
shaft marking 242. For example, a physician may slide the pointer
240 until it lines up with a shaft marking 242 visible through the
sleeve 238. This gives the physician a starting or reference point
so that a fixed-length or measured-length index step can be
performed by subsequently aligning other of the catheter markings
242 with the pointer 240. In certain embodiments, such a datum
device 230 advantageously facilitates accurate alignment of the
catheter 234 nearing fractions of a centimeter.
[0390] FIG. 20 illustrates an embodiment of a datum device 250
comprising an axially adjustable sleeve 252 provided adjacent to
the proximal end of a catheter 254. In particular, the adjustable
sleeve 252 is mountable to an introducer sheath hub 256. In certain
embodiments, the tubular sleeve 252 attaches directly to the
introducer sheath hub 256 and telescopes axially along the
longitudinal axis of the sheath hub 256. In such embodiments, the
sleeve 252 may preferably attach to the hub 256 using a snap fit, a
threaded-fit, or another like interface, such that the sleeve 252
maintains its location relative to the hub 256 during use.
[0391] In certain embodiments, a proximal end of the sleeve 252
functions as the datum pointer. In such embodiments, portions of
the sleeve 252 are preferably transparent or semi-transparent so
that catheter markings 260 may be observed as they approach, or are
substantially covered by, a reference marker 258 on the sleeve 252.
For example, the reference marker 258 may comprise a colored line,
or other identifying feature, that extends at least partially along
or near the proximal edge of the sleeve 252.
[0392] In use, the adjustable sleeve 252 advantageously provides an
adjustable datum or starting point from which each successive
indexing position can be measured. For instance, the sleeve 252 may
be coupled to the introducer hub 256 through a flexible (e.g.,
accordion-like) section that allows for extension/retraction of the
sleeve 252 axially along the catheter 254. In other embodiments,
the sleeve 252 may be movable (e.g., slidable) with respect to the
hub 256. In yet other embodiments, other arrangements may be used
as appropriate that allow for relative movement between the sleeve
252 and the hub 256 to provide for an adjustable return point. Such
embodiments provide a user with information relating to a relative
positioning of the catheter 254 and facilitates the prevention of a
heating element (e.g., at the end of the catheter 254) from
entering the introducer sheath. For example, in certain
embodiments, and as illustrated in FIG. 20, the datum device 250
may further include a "stop" mark that indicates to the user to
cease retracting the catheter into the sheath 256. Alternatively,
the user may partially withdraw a sheath such that a portion of the
sheath to be used as a datum (e.g., the proximal edge of the sheath
hub) is aligned with a catheter mark.
[0393] FIGS. 21A-21D illustrate an example of another embodiment of
a HAS indexing treatment device 270. In particular, FIG. 21A
illustrates the treatment device 270 as including a catheter 272
comprising a slidable outer sleeve 277 with hub 274 and as having
said outer sleeve 277 proximate a therapeutic element 280. For
example, the therapeutic element 280 may comprise a heating element
usable in the treatment of a HAS, such as in a method of treatment
similar to that described with reference to FIGS. 16A-16D. Thus, in
various embodiments, the therapeutic element 280 can comprise any
of the devices disclosed herein as suitable for use as the heating
element 208. The illustrated outer sleeve 277 further includes a
terminal portion 279. For instance, the terminal portion 279 may
comprise a different color and/or pattern than the remaining
portion(s) of the outer sleeve 277. For example, the terminal
portion 279 may be a red or yellow color to visually set apart the
terminal portion 279.
[0394] FIG. 21B illustrates an equivalent length of an introducer
sheath 282 next to the terminal portion 279 or the different color
and/or pattern section. As this section emerges from the stationary
introducer sheath 282, the physician is alerted to the proximity of
the therapeutic element 280 to the tip of the introducer sheath
278, which advantageously indicates the end of the indexed set of
treatments.
[0395] In certain embodiments, the therapeutic element 280 is
configured to limit travel of the outer sleeve 277, such as by
having an increased diameter and/or by providing a physical stop,
such as, for example, a ring attached to the proximal end of the
therapeutic element 280. In certain embodiments, the outer sleeve
277 is shorter in length than the main body of the catheter 272 by
approximately one index section.
[0396] In certain embodiments, during use just prior to the initial
treatment, the position of the outer sleeve 277 is adjusted (see
FIG. 21C) until a change in the markings on the outer sleeve 277 is
visible, as is shown in more detail in FIG. 21D. In such an
embodiment, a seal or anchor between the outer sleeve 277 and the
catheter 272 may be loosened and then the outer sleeve 277 moved
proximally relative to the catheter 272 while the main shaft of the
catheter 272 with heating element 280 remains stationary. Once the
introducer sheath 282-outer sleeve 277 interface reaches the next
index step transition, the seal or anchor between the outer sleeve
277 and the catheter 272 may be tightened. Such positioning
advantageously provides a user with a starting point such that
subsequent full indexed treatment steps can be more easily
performed.
[0397] FIG. 22A illustrates an embodiment of a portion of an
indexing system configured to facilitate the positioning of a
heating element during each indexing step. In particular, the
depicted embodiment provides automatic verification of a catheter
position within a HAS without requiring manual, visual or tactile
verification of the catheter position by the physician. In certain
embodiments, a plurality of mechanically, electrically or
magnetically detectable markings may be used to indicate to a
physician or to an electronic controller system that an indexing
position has been reached.
[0398] For example, as shown in FIG. 22A, a catheter shaft 290
includes a plurality of markings 292 that are detectable by a
sensor 294 to determine the relative position of the catheter shaft
290. In certain embodiments, the markings 292 comprise printed
magnetic ink marks that are detectable by a magnetic reading
sensor. In such embodiments, the sensor 294 may be placed adjacent
an introducer sheath hub and/or joined to a controller configured
to produce an audible or visible alert when each magnetic marker
passes underneath the sensor. This system allows for the index
distance to be tracked and indicated to the physician visually
and/or audibly without requiring the physician to observe the
markings 292 on the catheter 290. In certain embodiments, the
sensor 294 may further include an encoder, or other like circuitry,
that monitors the relative position of the catheter shaft 290
and/or number of index steps performed.
[0399] In an alternative embodiment, FIG. 22B shows a system 300
that uses a set of detents 302, or grooves, along a main body shaft
of a catheter 304. A sensor 306, which is configured to detect the
detents 302, is advantageously proximate the catheter main body
shaft 304. For example, in certain embodiments, the sensor 306 may
attach to an introducer sheath hub in order to hold the sensor 306
substantially stationary with respect to the hub. As the catheter
304 is moved proximally, a follower 308 of the illustrated sensor
306 physically "clicks" into each detent 302 that passes by the
sensor 306.
[0400] In certain embodiments, the follower 308 may advantageously
comprise a spring-loaded cam that provides an audible and tactile
resistance indicating proper index placement. In other embodiments,
the follower 308 may comprise a switch, or other like component,
connected to a system controller. Such a switch may inform the
system controller that the catheter 304 has been indexed to the
next position. The system controller may also alert the physician
that the catheter 304 is ready for treatment through audible and/or
visual indicators.
[0401] FIG. 23 illustrates an embodiment of a HAS treatment system
310 having a temperature sensor 312 placed on a catheter shaft 314.
In certain embodiments, the temperature sensor 312 comprises a
thermocouple, a thermistor, a resistive temperature device (RTD) or
a set of contacts that measures resistance. In certain embodiments,
the temperature sensor 312 is positioned on the catheter 314 at a
distance from a heating element 316 approximately equal to the
length of an introducer sheath 318. In certain embodiments, a
control system 320 may advantageously communicate with the
temperature sensor 312 through wired or wireless means.
[0402] In certain embodiments, the control system 320 monitors the
sensed temperature of the catheter 314 during treatment. For
example, the control system 320 may monitor the sensed temperatures
to determine when a treatment process has been completed. For
instance, when the temperature sensor 312 detects a significant
decrease in temperature relative to the patient's body temperature
(such as, for example, a decrease to room temperature caused by the
temperature sensor 312 leaving the HAS and entering the introducer
sheath), the control system 320 alerts the physician that the
treatment is complete. Such an alert may be, for example, in the
form of a visible light, and audible sound and/or another alert
signal.
[0403] FIG. 24 illustrates another embodiment of a HAS treatment
system 330, which includes a catheter distal section 332 having two
temperature sensors 334 and 336. The first temperature sensor 334
is positioned at or near a distal end 338 (e.g., approximately one
centimeter from the distal end 338) of a heating element 340, and
the second temperature sensor 336 is positioned at or near a
proximal end 342 (e.g., approximately one centimeter from the
proximal end 342) of the heating element 340. In embodiments in
which the heating element 340 comprises an electrically resistive
coil, one or more of the temperature sensors 334, 336 may be
positioned in the coil winds, such as, for example, approximately
one-half to approximately one centimeter from an end of the coil.
In certain embodiments, the temperature sensors 334, 336 preferably
communicate with a control system 344 configured to determine and
compare the temperatures at each end of the heating element
340.
[0404] Comparison of temperatures may be advantageous in detecting
heating with a portion of the heating element 340 within a sheath.
For instance, for the same power input along the length of the
heating element 340, a heating element portion within the sheath
may rise to a higher temperature relative to the heating element
portion outside the sheath. Furthermore, three or more temperature
sensors may be incorporated at the catheter distal section.
Alternatively, a thermocouple located proximal to the heating
element may be positioned to indicate a cooler air temperature as
the catheter shaft exits the introducer sheath.
[0405] In certain embodiments, the catheter 332 of FIG. 24 may be
placed in a HAS at a desired initial treatment site, which can be
located using any available technique. Energy can then be applied
to the HAS in an initial treatment step. After the initial
treatment, the catheter 332 is moved proximally, during which time
the control system 344 monitors the temperatures sensed by the two
temperature sensors 334, 336. In such a treatment, the section of
the HAS treated in the initial step may be at a higher temperature
than the surrounding portions of the HAS. A significant drop in the
temperature detected by the second sensor 336 relative to the
temperature detected by the first sensor 334 implies that the
heating element 340 has been at least partially moved proximally
out of the previously-heated region. Similarly, a significant drop
in the temperature (e.g., body temperature) detected by the first
temperature sensor 334 indicates that the heating element 340 has
been indexed to the next adjacent treatment position. In certain
embodiments, a power source may be manually activated or programmed
to automatically engage power once the heating element 340 reaches
its next indexed position.
[0406] In certain embodiments, by placing the temperature sensors
334, 336 between the ends 338, 342 of the heating element 340, the
indexed treatments may create an overlap of adjacent treatment
sections. In alternative embodiments, the temperature sensors 334,
336 may be positioned at or closer to the ends 338, 342 of the
heating element 340 in order to eliminate or reduce the amount of
overlap in adjacent indexing positions.
[0407] In other embodiments, rather than stopping the heating
element at a discrete series of treatment positions, as described
above, it is also possible to power the heating element to a target
temperature at or above a minimal treatment temperature and then
move the heating element along the complete treatment length of the
HAS substantially without stopping the movement of the heating
element while maintaining the treatment temperature. In one
embodiment, the movement of the heating element may begin after an
initial delay period that commences when the minimal treatment
temperature is reached.
[0408] In these embodiments, the therapeutic object is to conduct
treatment substantially continuously along the full length along
which the HAS is to be treated. Unplanned temporary stoppages of
the movement of the heating element, for example as a result of the
physician becoming distracted, the patient's position becoming
temporarily unfavorable, or for any other reason, are contemplated
within these continuous treatment embodiments. In other
embodiments, the movement of the heating element may be temporarily
slowed or stopped when the temperature of the heating element
deviates by a certain amount from the target temperature. In a
further embodiment, this deviation amount is 10 degrees Celsius or
less, and may be approximately 3 degrees Celsius in another
embodiment.
[0409] In one embodiment, the treatment temperature is an internal
temperature of the heating element, or is a temperature measured at
or adjacent to the heating element. In one embodiment, the minimal
treatment temperature is the temperature required to cause a
durable reduction of the diameter of the HAS, or to cause an
absence of patency in the HAS. This minimal treatment temperature
may be within a range of 80-140 degrees Celsius, and may be, for
example, approximately 120 degrees Celsius or approximately 95
degrees Celsius. Other minimal treatment temperatures are
contemplated, and may be appropriately set by one of skill in the
art depending on the conditions of use and the desired therapeutic
outcome.
[0410] In another embodiment, power is applied to the heating
element within a treatment power level range while the heating
element is moved along the treatment length of the HAS. In a
further embodiment, the treatment power level range is 20-40 W.
[0411] In one embodiment, the heating element may be elongated
along its longitudinal axis, and the treatment length of the HAS is
greater than the length of the heating element in the direction of
movement. In a further embodiment, the heating element has a length
that is at least fifteen times its width. In another embodiment,
the heating element has a length that is at least ten times its
width. In another embodiment, the heating element has a fixed
profile in a plane orthogonal to a longitudinal axis thereof.
[0412] In a further embodiment, the treatment method also
contemplates passing fluid through a lumen of the catheter to which
the heating element is coupled, thus heating the fluid, which then
exits at the catheter tip. The fluid may be saline, a
venoconstrictor, sclerosant, high-impedance fluid, physiologic
tissue adhesive, hydrogel, combinations of the same or the like.
The heating element may extend to the distal end of the catheter.
Furthermore, in one embodiment, the heating element may be a coil
with a varying pitch and/or spacing. The varying pitch or spacing
may be advantageously used to vary the heat output over the axial
length of the resistive element, for example in order to compensate
for the cooling effect of the fluid flow and maintain the treatment
temperature, to provide a greater treatment temperature at certain
areas of the coil for therapeutic reasons, or for any other reason
known in the art. In one embodiment, the coil pitch is varied so as
to provide a higher temperature at the proximal and distal end of
the treatment length of the HAS.
[0413] In a further embodiment, laser light is applied to the HAS
from the catheter to further reduce the patency of the HAS. In a
further embodiment, the light is applied from the distal end of the
catheter. The laser light may be generated by any means known to
those of skill in the art. For example, a 980 nm diode laser may be
employed, although generation of laser light having other
wavelengths, for example, within a range of 700-1100 nanometers, is
also contemplated.
[0414] FIGS. 25A and 25B illustrate embodiments of an indexing
device 350 usable with systems configured to facilitate regular
indexing movements of a catheter. For example, certain embodiments
of the device 350 may facilitate reproducible movement of a
catheter from a first position a subsequent indexed position.
[0415] As illustrated in FIG. 25A, the indexing device 350 includes
a pair of o-ring type donuts 352 and 354 configured to be movably
positionable on a catheter shaft. The donuts 352 and 354 are joined
together through a connector 356, such as a string. In other
embodiments, the donuts 352 and 354 may be connectable through
other flexible and/or collapsible devices such as, for example,
wires, springs, and the like.
[0416] As further illustrated in FIG. 25B, in certain embodiments,
during use the first donut 352 is positioned on a catheter 358
proximate an introducer sheath hub 359. In certain embodiments, the
first donut 352 is manually held against the introducer sheath hub
359. Alternatively, the first donut 352 may be configured to have
an interference fit or a mechanical luer lock fit to physically
and/or mechanically attach to the introducer sheath hub 359.
[0417] The second donut 354 is preferably permitted to move axially
along the length of the catheter 358. In certain embodiments, the
second donut 354 is further capable of gripping the catheter 358 to
move the catheter 358 axially as the second donut 354 is moved
toward the first donut 352. For example, the second donut 354 may
comprise a flexible or semi-flexible material that allows a user to
squeeze or apply pressure to the second donut 354 to grip the
catheter 358 extending therethrough.
[0418] In certain embodiments, at least one of the donuts 352, 354
comprises an elastic material. For example, at least one of the
donuts 352, 354 may comprise silicone, KRATON.RTM., urethane,
combinations of the same or the like. Such materials may
advantageously allow the donut to be pushed onto the catheter shaft
and to have an interference fit in order to help anchor the donut
in place until it is manually moved.
[0419] In certain embodiments, the device 350 is used to adjust the
position of the catheter 358 during the treatment of a section of a
HAS. For example, once the catheter 358 is placed in its initial
position such that a corresponding therapeutic element (e.g.,
heating element) is located at a desired initial treatment site,
both donuts 352, 354 are placed adjacent (such as by sliding at
least one of the donuts 352, 354) the introducer sheath hub 359. At
that point, the initial treatment process is performed.
[0420] Next, the catheter 358 is repositioned for the second
treatment process. In certain embodiments, the second donut 354 is
used to grip the catheter shaft 358 and both are moved in tandem
away (proximally) from the first donut 352 and introducer sheath
hub 359 until the movement of the second donut 354 and catheter
shaft 358 is arrested, or stopped, by the connector 356. At this
point, a therapeutic element of the catheter 358 is preferably in a
new adjacent section for the second treatment.
[0421] In certain embodiments, the connector 356 is preferably of a
length that corresponds to the length of the desired indexing step.
For example, in certain embodiments, the length of the connector
356 may be substantially the same as the length of the
corresponding therapeutic element. In yet other embodiments, the
length of the connector 356 may be shorter than the length of the
therapeutic element such that successive indexed treatments have a
partial overlap. In yet other embodiments, the length of the
connector 356 may be adjustable to facilitate use of the device 350
with different catheters having different sized therapeutic
elements or to facilitate the adjusting of the length of each
treated portion.
[0422] FIGS. 26A and 26B illustrate alternative embodiments of
indexing devices usable with systems configured to facilitate
regular indexing movements of a catheter. In particular, FIG. 26A
illustrates an indexing device 360 having a pair of elongated rings
361 and 362 connected by a rigid sliding rod 363. In the
illustrated embodiment, the rod 363 extends through openings 364
and 365 of the rings 361 and 362, respectively, and is preferably
configured to limit relative axial movement between the first ring
361 and second ring 362 beyond a predefined distance. As shown, the
rod 363 further comprises stops 366 at opposing ends of the rod 363
that are configured to limit travel of the first and second rings
361, 362. In particular, the stops 366 comprise a disk-shaped head
and are advantageously of a larger size than the openings 364 and
365 such that the openings 364, 365 cannot easily pass over the
stops 366.
[0423] As shown in FIG. 26A, the rings 361 and 362 further comprise
catheter openings 367 and 368, respectively, that allow for a
corresponding catheter to pass therethrough. Use of the indexing
device 360 is similar to the use of the indexing device 350
described with reference to FIGS. 25A-25B. That is, the elongated
rings 361, 362 are used similarly to the donuts 352, 354 to move a
catheter shaft a predefined distance, which distance is determined
by the length of the rod 363.
[0424] FIG. 26B illustrates an alternative embodiment of an
indexing device 370 that includes first and second rings 371 and
372 having a wish-bone like shape. In such an embodiment, the legs
of at least one of the rings 371, 372 may fit around the surface of
a catheter shaft. In certain embodiments, such a configuration
advantageously allows a user to more easily slide at least one of
the rings 371, 372 along the catheter shaft and to remove the
device 370 from the catheter shaft.
[0425] In certain embodiments, at least one of the rings 371, 372
comprises an elastic material. For example, at least one of the
rings 371, 372 may comprise silicone, KRATON.RTM., urethane,
combinations of the same or the like. Such materials may
advantageously allow the ring to be pushed onto the catheter shaft
and to have an interference fit in order to help anchor the ring in
place until it is manually moved. In certain embodiments, the rings
371 and 372 may be connectable by a sliding rod, a string, or other
like device as described in more detail above.
[0426] FIGS. 27, 28A and 28B further illustrate embodiments of
indexing devices employing various linkages to index a catheter by
a desired amount. FIG. 27 illustrates an indexing device 374
comprising a linkage with two arms 375 and 376. In certain
embodiments, the linkage arms 375, 376 are of substantially equal
length and are hingedly joined together at one end. In certain
embodiments, the range of movement of the linkage arms 375, 376 is
from approximately 0 degrees (e.g., the arms 375, 376 extending in
parallel directions) to approximately 180 degrees (e.g., the arms
375, 376 fully extended). In certain embodiments, the range of
motion of the arms 375, 376 may be limited by attached cylindrical
ends 377 and 378 coming together (e.g., at approximately 0 degrees)
and when the linkage arms 375, 376 are in tandem.
[0427] As shown, the first linkage arm 375 is connected to the
cylindrical end 377, and the second linkage arm 376 is connected to
the cylindrical end 378. In certain embodiments, the first and
second cylindrical ends 377, 378 are configured to anchor the
indexing device 374 to a catheter shaft. For example, the second
cylindrical end 378, which may be hingedly attached to the linkage
arm 376, may be configured to attach to an introducer sheath hub
associated with a catheter.
[0428] In certain embodiments, the first cylindrical end 377
comprises a grip structure 380 that is hingedly attached to the
linkage arm 375. For example, the grip structure 380 may allow the
first cylindrical end 377 to selectively maneuver along a catheter.
In certain embodiments, the grip structure 380 is configured to
straddle a catheter shaft. As shown, the grip structure 380 may
comprise an open section that allows reception of the catheter
therein without the need for threading the catheter through the
center of the grip structure 380. The open section advantageously
includes two tab-like extensions that a user may pinch (such as
with a thumb and a forefinger) to capture the catheter shaft. In
certain embodiments, the inner radial surface of the grip structure
380 may comprise, for example, a soft tacky type of silicone or
KRATON.RTM..
[0429] In certain embodiments, during use, the indexing device 374
is coupled to a catheter shaft such that the catheter shaft extends
through both the ends 377, 378. Prior to an initial treatment, the
end 378 is moved along the catheter shaft and brought proximate an
introducer hub, and the end 377 is moved adjacent the end 378.
After treatment of the section has been completed, the user grips
the end 377 and draws out the catheter until the device 374 is in a
fully extended position (e.g., the legs 375 and 376 are in line).
Such a full extension preferably corresponds to the index treatment
length. The user then loosens the grip of the end 377 on the
catheter shaft and moves the end 377 proximate the end 378. At this
point, a second treatment may be performed and the process is
repeated as appropriate.
[0430] In certain embodiments, the indexing device 374 may further
comprise a spring or elastic component (not shown) further linking
the two linkage arms 375 and 376 to keep the device 374 in a
preferred position when not in use. For example, such a preferred
position may include the grip structure 380 being located adjacent
to the second cylindrical end 378 and a corresponding introducer
sheath hub.
[0431] FIG. 28A illustrates another embodiment of an indexing
device 390 similar to the indexing device 374 of FIG. 27. As shown,
the indexing device 390 comprises two sets of arms. In particular,
the indexing device 390 comprises a top set of arms 392 and 394
that are hingedly connected by a first connector 396. The
illustrated indexing device 390 further comprises a bottom set of
arms 398 and 400 that are hingedly connected by a second connector
402.
[0432] The indexing device 390 also includes a first anchor 404
that is hingedly connected to the first top arm 392 and the first
bottom arm 398. Likewise, a second anchor 406 hingedly couples the
second top arm 394 and the second bottom arm 400. In certain
embodiments, the second anchor 406 comprises a structure similar to
the cylindrical end 378 of FIG. 27 and is configured to attach to,
or be included as part of, an introducer sheath hub.
[0433] In certain embodiments, at least one of the sets of linkage
arms 392, 394 and 398, 400 may also include a spring or elastic
component to keep the indexing device 390 in a preferred, or
default, position when not in use. In certain embodiments, the
preferred position may include the first and second anchors 404 and
406 substantially adjacent to an introducer sheath hub.
[0434] In certain embodiments, the two linkage arms sets are
preferably made of two structures of substantially equal length.
For example, all four linkage arms 392, 394, 398 and 400 may be of
a substantially equal length, with each pair being hingedly
attached together. In certain embodiments, the range of movement of
each hinged pair of arms is preferably from approximately 0 degrees
to approximately 180 degrees. In other embodiments, the range of
movement of the hinged arms of the device 390 may be limited to
narrower ranges as desired.
[0435] In certain embodiments, the first anchor 404, includes a
grip structure that is hingedly attached to arms 392 and 398. FIG.
28B illustrates further details of inner components of the first
anchor 404. In particular, FIG. 28B illustrates a portion of a
housing 408 of the first anchor 404. Within a housing 408 are two
rings 410 usable, for example, to grip a catheter shaft 412
extending through the first anchor 404. In certain embodiments, the
two rings 410 may provide an interference fit on the catheter shaft
412. When the first anchor 404, for example, is moved away from an
introducer sheath hub, the rings 410 may be moved toward a tapered
inner surface 414 of the housing 408, which may cause the rings 410
to tighten their fit on the catheter shaft 412. In certain
embodiments, the tapered inner surface 414 may be of an angle to
accommodate two rings of different sizes, a single ring, or more
than two rings, for improved gripping forces on the catheter shaft
412.
[0436] In certain embodiments, the first connector 396 and second
connector 402 advantageously facilitate movement of the indexing
device 390. For example, a user may press on one or both of the
connectors 396, 402 to extend the indexing device 390 such that the
angles between the sets of arms increase. Use of the indexing
device 390 may be similar to the method of use described with
reference to the indexing device 374 of FIG. 27.
[0437] FIGS. 29A-29E illustrate one method of use of the indexing
device 390. For example, a single indexing step during a treatment
process. In FIG. 29A, the indexing device 390 is in a default or
"zero point" position and is located on the catheter shaft 412 such
that the catheter shaft 412 extends though the first and second
anchors 404 and 406 of the indexing device 390. The first anchor
404 is located proximate the second anchor 406, which is adjacent a
hub of an introducer 418. In certain embodiments, the "zero point"
position corresponds to the position and/or configuration of the
indexing device 390 during treatment of a patient.
[0438] FIG. 29A further illustrates the catheter shaft 412
including several markings, including a first mark 420, a second
mark 422 and a third mark 424. As shown, the first anchor 404 of
the indexing device 390 is substantially aligned with the third
mark 424 on the catheter shaft 412.
[0439] FIG. 29B illustrates the position of the indexing device 390
during an indexing step. In particular, FIG. 29B illustrates the
indexing device 390 being in a partially extended position as a
result of pressure being applied to one or both of the connectors
396, 402. As the user presses one or both of the connectors 396,
402, the hinged arms of the indexing device 390 begin to extend
radially (i.e., the angles between each set of arms increases), and
the first anchor 404, which advantageously grips the catheter 412,
draws the catheter 412 from the introducer 418.
[0440] FIG. 29C illustrates the indexing device 390 in a fully
extended position such that the pairs of legs each have
approximately a 180 degree angle therebetween. In FIG. 29C, a
fourth mark 426 along the catheter shaft 412 also becomes visible
as it is drawn from the introducer 418.
[0441] FIG. 29D illustrates a configuration of the indexing device
390 as it returns to the "zero point" position. In particular,
during this return state, the first anchor 404 releases its grip on
the catheter 412 and slides toward the second anchor 406. Thus, the
catheter 412 remains substantially stationary during the indexing
device's return to the "zero point" position. In certain
embodiments, an elastic or spring-like mechanism causes the
indexing device 390 to automatically return to the "zero point"
position once pressure is released from one or both of the first
and second connectors 396 and 402.
[0442] FIG. 29E illustrates the final state of a single indexing
step during a treatment process. In particular, the indexing device
390 is returned to the "zero point" position. Furthermore, the
first anchor 404 is substantially aligned with the next catheter
mark (i.e., the fourth mark 426). At this point, a second indexed
treatment may be performed.
[0443] FIG. 30A illustrates another embodiment of an indexing
system 430 that comprises a mechanical indexing handle 432. In
certain embodiments, the indexing handle 432 is threaded over a
main body of a catheter 434. In certain preferred embodiments, the
indexing handle 432 is removable from the catheter 434.
[0444] As shown, the illustrated indexing handle 432 further
comprises a distal end 436 that may be configured to securely
attach to a hub of an introducer sheath. The indexing handle 432
further includes a trigger 438, the activation of which causes a
corresponding movement of the catheter 434 through the indexing
handle 432. For example, the indexing handle 432 may be configured
to incrementally move proximally the main body of the catheter 434
a set distance relative to the introducer sheath hub.
[0445] In certain embodiments, a catheter cable 440 extends from
the catheter 434 and is configured to communicate with a remote
generator. For example, the generator may provide energy to the
catheter 434 to activate a therapeutic element associated
therewith.
[0446] In certain embodiments, the indexing handle 432 has a set
trigger travel or a set index distance. As the trigger 438 is
activated, a gripping mechanism within the indexing handle 432
grasps the catheter 434 and moves the catheter 434 in a proximal
direction relative to the indexing handle 432, which preferably
remains stationary. At the end of the incremental movement of the
catheter 434, the inner mechanism of the indexing handle 432 then
releases the catheter 434 and returns to an initial position, such
as a "zero point" position, within the indexing handle 432.
[0447] In certain embodiments, the inner gripping mechanism
comprises a structure similar to the structures described with
reference to FIG. 28B. In yet other embodiments, the inner gripping
mechanism of the indexing handle 432 comprises a cam-action
component that is pushed against the main body of the handle 432 as
the component starts to pull the catheter 434 and then is released
at the end of the travel or index distance. In certain embodiments,
motive force for the catheter movement may be provided by a
motor-driven worm gear, a pneumatic piston, or other means.
[0448] Another embodiment of an index handle 450 is illustrated in
FIG. 30B. As shown, the index handle 450 comprises a first cable
452 and a second cable 454. In certain embodiments, the first cable
452 extends to a remote generator capable of supplying energy to
the catheter 456. The second cable 454 may extend from the indexing
handle 450 to a catheter 456.
[0449] In certain embodiments, the indexing handle 450 may include
one or more switches or controls for controlling power supplied by
the generator to the catheter 456. For example, the indexing handle
450 may include an ON/OFF button to remotely control the power from
the generator during treatment. In certain embodiments, the
indexing handle 450 may comprise a switch that signals the
generator to power up or power down.
[0450] FIGS. 31A-31D illustrate several embodiments that include a
remote switch usable to control the supplying of energy to a
catheter. In particular, FIG. 31A shows a catheter handle 460
connected through a cable 462 to a generator 464. The handle 460
further comprises a set of buttons 466 usable to control energy
supplied by the generator 464. Although two buttons are shown for
exemplary purposes, one or more buttons may be incorporated on the
handle 460.
[0451] FIG. 31B illustrates an alternative embodiment wherein a
catheter handle 470 is coupled through a cable 472 to a remote
switch 474 separate from the handle 470. In certain embodiments,
the cable 472 and a cable 476 from the generator couple to the
catheter handle 470. The remote switch 474 and/or switches on the
handle 470, for example, may be used to control the associated
generator.
[0452] FIG. 31C illustrates yet another embodiment showing a remote
switch 480 directly coupled through a cable 482 to a power
generator 484. Also shown is a separate cable 486 coupling the
generator 484 to an indexing handle 488. FIG. 31D illustrates a
similarly embodiment wherein a remote foot switch 490 is directly
coupled through a cable 492 to a generator 494. Also shown in FIG.
31D is a second cable 496 coupling the generator 494 to an indexing
handle 498.
[0453] Although described with reference to particular embodiments,
other configurations for indexing systems may be used for a
treatment process of a HAS. For example, communication between an
indexing device and a generator may take place through wired or
wireless (e.g., radio frequency) communications. In certain
embodiments, communications between one or more switches and/or
controls may take place through wired or wireless communication
channels.
[0454] FIG. 32 illustrates an embodiment of screen shot of an
interface 500 of an electronic control system usable with
embodiments of indexing systems disclosed herein. In certain
embodiments, software of the control system determines the length
and/or number of index steps performed and/or to be performed based
on the information input by the user. For example, relevant
information may include, but is not limited to, the length of the
inserted portion of the catheter and the overall length of the
introducer sheath from its tip to the back end of the hub.
Appropriate software modules may then be used to determine the
length of an index step so that successive treatments can
overlap.
[0455] As shown, the illustrated interface 500 includes multiple
display components to provide a user with information concerning a
treatment process and input devices for receiving information from
a user. In particular, the interface 500 includes a total elapsed
time display 502 that indicates how much time has passed since the
beginning of the procedure. An index elapsed time 504 indicates the
amount of time passed for a particular index treatment.
[0456] A temperature display 506 provides the temperature of the
current treatment, and an index step display 508 and a progress
display 509 indicate which step is currently being performed with
respect to the entire treatment process. In certain embodiments,
information for one or both of the index step display 508 and
progress display 509 is determined by a controller using physician
input relating to the length of the catheter portion inserted into
the introducer and/or the length of the introducer sheath.
[0457] Although the interface 500 is depicted with reference to a
particular embodiment, various other displays and/or input devices
may be used. Furthermore, not all display components depicted in
FIG. 32 need be part of the interface 500.
[0458] FIG. 33 illustrates a general flowchart of an indexing
treatment process 600, according to one embodiment. In certain
embodiments, the process 600 is carried out, at least in part, by
one of the indexing systems described previously herein.
[0459] As illustrated, the process 600 begins at Block 602 by
powering on an indexing treatment system. At Block 604, a generator
of the indexing system performs a self-check to determine, among
other things, if the generator is in proper condition to perform a
treatment. At block 606, the catheter is coupled to the generator
and a catheter identification check is performed to associate the
proper software to the treatment catheter. For example, a physician
may visually verify that the correct catheter has been selected, or
such verification may be performed automatically by a control
system, such as by electronically reading a tag associated with the
catheter.
[0460] At Block 608, a physician inputs data into the control
system indicating that the catheter has been inserted into a HAS of
a patient. Alternatively, the catheter and/or software may sense
body temperature as an indication that the device has been inserted
into the body. In certain embodiments, the physician inputs the
length of the inserted portion of the catheter. In other
embodiments, the physician may input a specific catheter marking
that is initially aligned with a introducer sheath associated with
the catheter.
[0461] At Block 610, the physician inputs into the control system
the length of the introducer sheath. At Block 612, the treatment
process begins. In certain embodiments, a therapeutic element, such
as a heating element, of the catheter is energized through the use
of at least one power generator. For example, the therapeutic
element may treat a section of the HAS through heat, RF energy, or
the like.
[0462] Following Block 612, Blocks 614, 616, 618, and 620 may be
performed concurrently or substantially concurrently. At Block 614,
an identification of the specific segment being treated is
displayed to the user. For example, the control system may
correlate a first segment with a number "1" and display this number
to the user, such as in a manner described with reference to the
display illustrated in FIG. 32. At Block 616, an identification of
the number of treated segments is displayed. At Block 618, a
temperature of the current treatment is displayed. At Block 620,
the power being currently used during the treatment is
displayed.
[0463] After the treatment for the specific segment has completed,
the process 600 proceeds with Block 622. At Block 622, the process
600 causes the generator to enter a standby mode such that little
or no power is applied to the therapeutic element of the catheter.
The process 600 then determines at Block 624 whether there are
remaining segments of the HAS to be treated. If there are segments
that remain to be treated, the process 600 proceeds with Block 626,
wherein the therapeutic portion of the catheter is moved to the
next segment and an input signal is provided to the control system
to begin the next indexed treatment. For example, in certain
embodiments, one of the indexing devices described previously
herein is used to adjust the catheter position between successive
indexing treatments. If there are no segments remaining to be
treated, the process 600 proceeds with Block 628, wherein the
physician powers down the generator.
[0464] Although the process 600 has been described with reference
to particular embodiments, the process 600 may be performed without
executing all the blocks illustrated in FIG. 33, or some of the
illustrated blocks may be modified. For example, either or both of
Blocks 608 and 610 may be performed automatically by the control
system. For instance, in certain embodiments, the control system
may monitor the length of the catheter portion inserted into the
HAS.
[0465] In addition, the order of the blocks illustrated in FIG. 33
may be modified in other embodiments. For example, the process 600
may perform any combination of Blocks 614, 616, 618 and 620
simultaneously or in any order to provide the user with the
pertinent information relating to the treatment process.
[0466] Certain methods of using an indexing HAS treatment system
will now be described. The methods described herein can employ any
suitable device described above or otherwise known to the skilled
artisan. In the methods described below, the direction "distal" or
"proximal" will generally refer to the catheter orientation,
wherein "distal" is toward the catheter end inserted into the body
and "proximal" is toward the end the user holds during
operation.
[0467] For example, in certain embodiments, an indexing method may
comprise inserting a heating element with a length of about five to
about seven cm into a distal-most section of a HAS to be treated.
For instance, for a saphenous vein, where the catheter is advanced
antegrade from the knee area to the groin area, the catheter-distal
direction is limb-proximal).
[0468] The heating element is then aligned with the starting
treatment location within the HAS. In certain embodiments, a
tumescent solution may be injected to surround and compress the HAS
(assisting in evacuation of fluid from within the HAS, providing a
thermal heat sink to protect surrounding tissue, and providing
anesthetic to the surrounding tissue). Compression of the HAS, such
as through manual compression by the physician, may also be
performed.
[0469] Power is then be applied to the heating element for a
desired length of time to treat the segment of the HAS adjacent to
the heating element. After a desired dwell time, the power supply
to the heating element can be reduced or shut off. With the power
off (or substantially reduced), the heating element may then be
indexed proximally (i.e., the heating element can be moved
proximally until the distal end of the heating element is adjacent
to the proximal end of the previously-treated segment of the
HAS).
[0470] An example of an index treatment includes treatment at a
temperature between approximately 95.degree. C. and approximately
150.degree. C. for a dwell time of approximately twenty seconds or
less. In a more preferred embodiment, the preferred index treatment
is performed at approximately 120.degree. C. for a dwell time of
approximately twenty seconds. The ramp time to temperature may be
approximately ten seconds or less, with a preferred time of
approximately four seconds or less. In certain embodiments, the
intent of a short ramp time is to advantageously reach and maintain
the treatment temperature quickly in order to apply heat to the HAS
in a highly-localized manner.
[0471] In certain embodiments, the HAS heating is advantageously
applied for a sufficient time to allow thermal conduction along
collagen-dense regions (such as a vein wall) to cause
fully-circumferential HAS (e.g., vein) wall shrinkage. In certain
embodiments, the heating element may be provided a constant power
input, independent of thermal measurement.
[0472] Once a section is treated, the distal therapeutic portion of
the catheter is moved to the adjacent section. In certain
embodiments, the indexing of the catheter provides an overlap
portion of approximately one centimeter or less to substantially
reduce or eliminate the number of under-treated sections or gaps as
mentioned earlier. This process is repeated until the treatment of
the HAS is complete. In some embodiments, an automatic mode may
provide a signal (visual and/or audible) to the user to alert them
when to move the catheter to the next treatment section.
[0473] In other embodiments, higher temperatures such as, for
example, approximately 200.degree. C. or approximately 500.degree.
C., at a shorter dwell time are also possible depending on
circumstances of the treatment. In yet other embodiments, the
treatment process may comprise a multi-step heating process, such
as a planned initial temperature overshoot followed by a lower
temperature. For example, the HAS may be treated at a first
temperature (e.g., approximately 110.degree. C.) for a first
portion of the process and a second temperature (e.g.,
approximately 95.degree. C.) for a second portion of the process.
Alternatively, a succession of heating and dwell periods may be
employed (e.g., ten one-second heating periods spaced by nine
one-second off periods, or five three-second heating periods at
approximately 140.degree. C. spaced by four one-second off periods)
to limit the spread of conductive heating such as in the case where
the dwell time may allow thermal relaxation. The total energy input
to the HAS, as dependant upon the power level over time, may
preferably be within the range of 40 to 200 Joules per centimeter
and, more preferably, within the range of 70 to 140 Joules per
centimeter.
[0474] In certain embodiments of the catheter system, fluid may be
injected through a lumen of the catheter to flow through a region
heated by the heating element such that the injected fluid becomes
heated to a therapeutic temperature (e.g., approximately
80-100.degree. C.) to extend the length of heating along the HAS.
The rate of fluid injection may be controlled by a fluid drip rate
within a drip chamber, by a fluid pump such as a peristaltic pump,
by regulated pressure input to the lumen optionally with a
resistive orifice, or by other means.
[0475] FIGS. 34A-34C illustrate one embodiment of a method of use
of a system for treating a HAS. In certain embodiments, the
treatment system may comprise one of the indexing treatment systems
disclosed herein, such as any of the catheters 202, 202', 900, 950.
For ease of description, each of FIGS. 34A-34C illustrates one of
three different processes or stages of the method of use. A skilled
artisan will recognize, however, that any of the described
processes/stages may be combined into a single process or stage
and/or may be subdivided into additional processes or stages.
[0476] In particular, FIG. 34A illustrates a catheter preparation
process 700 that begins with Block 702, wherein a user turns on a
generator. In certain embodiments, the generator may comprise an RF
generator, such as, for example, the RFGPlus RF generator. Once the
generator is turned on, an interface of the generator, such as a
display, may prompt the user to connect an appropriate treatment
device, such as one of the catheter devices disclosed herein, to
the generator.
[0477] At Block 704, the user couples the catheter device to the
generator. In certain embodiments, to determine if the catheter is
properly coupled to the generator and/or if the appropriate
catheter is being used, the generator may sense an identification
resistor or other identifying information associated with the
catheter. In yet further embodiments, the generator may also
determine from the identification information certain attributes
and/or operational characteristics of the attached catheter device.
For instance, the generator may determine the length of the
catheter being used (e.g., 60 or 100 centimeters). The generator
may also specify a certain logic set (e.g., program, or set of
default parameters) to associate with the catheter being used.
[0478] At Block 706, a temperature flag of the generator is raised
until a temperature of the attached catheter is greater than
33.degree. C. Such a flag, in certain embodiments, helps prevent a
user from powering-up the treatment system while the catheter is
still positioned outside the patient's body. For instance, the
temperature may be read from one or more temperatures sensors or
like devices positioned near or on a heating coil of the catheter.
Once the temperature of the catheter exceeds 33.degree. C., the
flag is preferably removed. If at some point during the treatment
of the patient the catheter temperature drops below approximately
25.degree. C., the generator may raise the flag again.
[0479] At Block 708, the generator interface displays that the
catheter device is properly connected to the generator. For
instance, the interface may display the message "DEVICE CONNECTED.
VERIFY TEMPERATURE." In certain embodiments, the message is
displayed for approximately five seconds. At Block 708, the
generator may also display the message "PRESS RF POWER BUTTON TO
ENTER READY MODE." In certain embodiments, an "RF ON" control
(e.g., button) of the generator remains dark (e.g., not lit or
highlighted) until the catheter is ready to receive power from the
generator.
[0480] At Block 710, the user inserts the catheter into the body of
the patient. At Block 712, the user activates the "RF ON" button on
the generator to enable power delivery to the catheter. At Block
714, in certain embodiments, a start treatment message is displayed
above the "RF ON" button, the "RF ON" button flashes green, and/or
a message is displayed reading "PRESS HANDLE BUTTON OR START RF
TREATMENT TO TREAT." The generator interface may also indicate a
total treatment time (such as the cumulative time of treatment of a
group of segments).
[0481] At Block 716, the user activates a control (e.g., a button)
on the handle of the treatment device or a start RF treatment
button on the generator to begin the RF treatment. At Block 718,
the catheter preparation process 700 determines if the low
temperature flag is raised or if it has been lowered. Such a
determination may advantageously indicate to the user if the
catheter device has been inserted into the patient's body. This may
help to prevent unintentional delivery of power with the catheter
device outside of the patient. If the low temperature flag is not
raised, the catheter preparation process 700 proceeds with Block
720.
[0482] At Block 720, the generator initiates delivery of power to a
therapeutic portion (e.g. a heating coil) of the catheter device.
In certain embodiments, the generator also provides one or more
indications to the user that delivery of power has initiated. For
instance, the "RF ON" button may turn white, the generator
interface may display a "STOP RF TREATMENT" option, the generator
may provide an audible tone, combinations of the same or the like.
In certain embodiments, the generator then begins to ramp up the
temperature of the catheter device to initiate treatment.
[0483] If at Block 718 the low temperature flag is raised, the
catheter preparation process 700 continues to Block 722. At Block
722, the generator interface displays "LOW TEMPERATURE. VERIFY
DEVICE IS IN THE BODY--PRESS OK OR HANDLE BUTTON TO CLEAR AND START
RF TREATMENT." At Block 724, the catheter preparation process 700
determines if the "OK" button or the handle button has been
pressed. If either button has been pressed, the catheter
preparation process 700 proceeds with Block 720. If neither button
was pressed, the catheter preparation process 700 continues with
Block 726. At Block 726, the process 700 determines if the cancel
button was pressed. If the cancel button was not pressed, the
catheter preparation process 700 returns to Block 722. If the
cancel button was pressed, the process 700 returns to Block
716.
[0484] Once RF power is initiated, the catheter preparation process
700 moves to a Phase 1 process 730, an embodiment of which is
illustrated in more detail by the flowchart of FIG. 34B. In certain
embodiments, the generator provides approximately forty watts of
power to the catheter device for approximately six seconds during
the Phase 1 process 730.
[0485] As illustrated, the Phase 1 process 730 begins with Block
732, wherein the generator interface displays the message "DEVICE
SHOULD REACH TARGET TEMPERATURE IN `X` SECONDS," wherein "X"
represents a time limit such as, for example, five seconds. In yet
other embodiments, other appropriate time limits may be used, such
as, for example, ten seconds.
[0486] At Block 734, the Phase 1 process 730 determines if the
temperature of the device has reached, for example, a set
temperature of 120.degree. C., 100.degree. C. or 83% of the set
temperature in less than three seconds. For instance, in certain
preferred embodiments, the set temperature is generally attained
within approximately 1.7 seconds after the initiation of power. If
the indicated temperature has not been reached in the allotted
time, the Phase 1 process 730 moves to Block 736, wherein the
generator may issue an audible and/or visual alert. For instance,
the generator display may show a message "ADVISORY: LOW
TEMPERATURE, HIGH POWER. ADJUST COMPRESSION." In certain
embodiments, the displayed message remains until the error
condition is corrected.
[0487] At Block 734, if the temperature reaches the appropriate
level within the allotted time, the Phase 1 process 730 continues
with Block 738. At Block 738, the Phase 1 process 730 determines if
the temperature of the device has reached the set temperature in
less than, for example, six seconds. If the temperature has not
reached the set temperature in less than six seconds, the Phase 1
process 730 returns to Block 736.
[0488] If the temperature has reached the set temperature in less
than six seconds, the Phase 1 process 730 proceeds with Block 740.
At Block 740, the generator interface displays the message "TARGET
TEMPERATURE REACHED--VESSEL HEATING IN PROGRESS." In certain
embodiments, at this point, the generator issues a Phase 2 tone and
maintains the current (e.g., set) temperature.
[0489] Returning to Block 736, once the error condition is cleared,
the Phase 1 process 730 moves to Block 742, wherein the generator
determines if the temperature of the catheter device has reached
approximately 119.degree. C. (approximately the set temperature) in
less than six seconds. If so, the Phase 1 process 730 proceeds with
Block 740.
[0490] If the catheter temperature has not reached the set
temperature in the allotted amount of time, the Phase 1 process 730
proceeds with Block 744. At Block 744, the RF power delivery is
terminated. In certain embodiments, the generator may issue a
termination beep and/or display the message "RF CYCLE STOPPED AT
"X" SECONDS. TARGET TEMPERATURE NOT REACHED." In certain
embodiments, this message may remain until any generator key is
pressed, the handle button is pressed, the RF treatment is resumed
at a new location, and/or after a ten-second time out. The Phase 1
process 730 then returns to Block 714 of the catheter preparation
process 700.
[0491] After Block 740, the Phase 1 process 730 continues with a
Phase 2 process 750, an embodiment of which is illustrated in more
detail by the flowchart of FIG. 34C. In certain embodiments, the
generator reduces the power output to the catheter device during
the Phase 2 process 750, which preferably lasts for approximately
fourteen seconds.
[0492] The Phase 2 process 750 begins at Block 752, wherein the
process 750 monitors (i) if the temperature of the catheter device
drops below 118.degree. C. (approximately the set temperature) for
more than two seconds or (ii) if the power exceeds twenty-four
watts for more than five seconds. Such conditions may occur, for
example, if there is too much fluid present in the treatment region
of the HAS (e.g., insufficient compression applied to the patient's
limb). In certain embodiments, such monitoring is performed until
the final five seconds of the Phase 2 process 750. Thus, such
embodiments of the process 750 ignore temperature decreases and/or
power increases during the final five seconds of the treatment.
[0493] If either condition described in Block 752 does occur, the
Phase 2 process 750 proceeds with Block 754, wherein the generator
interface displays the message "ADVISORY: LOW TEMPERATURE, HIGH
POWER. ADJUST COMPRESSION." In certain embodiments, when such a
condition is corrected, the generator clears the warning message.
Following Block 754, or if neither of the specified conditions
occurs at Block 752, the Phase 2 process 750 continues with Block
756. At Block 756, the generator provides an "end of cycle" alert
(e.g., a beep). In addition, in certain embodiments, a message on
the generator interface may read "PRESS HANDLE BUTTON OR START RF
TREATMENT TO TREAT." The Phase 2 process 750 then returns to Block
714 of the catheter preparation process 700 to begin another
treatment (e.g., a treatment of another section of the HAS).
[0494] FIGS. 34A-34C thus illustrate one embodiment of a method of
treating a hollow anatomical structure, comprising: inserting a
heat delivery device into a hollow anatomical structure; delivering
power to the heat delivery device during a temperature ramp-up
phase; measuring time elapsing during power delivery; monitoring
operation of the heat delivery device; and if the operation of the
heat delivery device during or shortly after said temperature
ramp-up phase is acceptable, delivering power to the heat delivery
device after said temperature ramp-up phase.
[0495] In variations of the method, the method further comprises:
delivering power to the heat delivery device to reach a first
treatment temperature; and delivering power to the heat delivery
device to reach a subsequent second treatment temperature which is
lower than said first treatment temperature.
[0496] In further variations of the method, the heat delivery
device is an electrically driven heating element, an electrode, or
a laser. When the heat delivery device comprises an electrically
driven heating element, an energy coupling surface of the heating
element may have a distal-to-proximal length which is at least
fifteen times the width of the heating element.
[0497] Further variations of the method additionally comprise
measuring a temperature of at least one of (i) at least a portion
of the heat delivery device, and (ii) a portion of the hollow
anatomical structure being treated. An example of this is shown in
FIG. 34B in Blocks 734, 738, and 742, which employ the temperature
data measured. In another variation of the method, monitoring
operation of the heat delivery device comprises determining whether
the measured temperature reaches or exceeds a target temperature
within a time limit. An example of this is shown in FIG. 34B in
Block 738, in which the process checks whether the temperature has
reached a set temperature (in one variation, 120.degree. C.). In
another variation, monitoring operation of the heat delivery device
comprises determining whether the measured temperature falls below
a target temperature within a time limit.
[0498] In a further variation, the method additionally comprises
proceeding to deliver power to the heat delivery device after the
temperature ramp-up phase only when the target temperature is
reached or exceeded within the time limit. An example of this is
shown in Block 744 in FIG. 34B, in which the power to the heat
delivery device is turned off when the set temperature is not
reached within a period of six seconds.
[0499] In another variation of the method, monitoring operation of
the heat delivery device comprises comparing a measurement of
electrical impedance with a reference waveform.
[0500] A further variation of the method additionally comprises
displaying an instruction to adjust treatment of the hollow
anatomical structure if the operation of said heat delivery device
during said temperature ramp-up phase is not acceptable. In a
further variation of this method, displaying an instruction to
adjust treatment of said hollow anatomical structure comprises
displaying an instruction to adjust the compression of the hollow
anatomical structure. An example of this is shown in FIG. 34B in
Block 736, in which a display indicates that compression should be
adjusted when the temperature has not reached 100.degree. C. within
three seconds, or 83% of the set temperature.
[0501] In a variation of the method, the hollow anatomical
structure is a vein.
[0502] Although the foregoing method of use has been described with
reference to particular embodiments, in other embodiments not all
of the disclosed blocks need be performed, or additional blocks may
be included. For example, different types of messages may be
displayed on the generator interface and/or on a computer display
coupled to the generator. In yet other embodiments, certain blocks
may be combined into a single block, or one or more blocks may be
subdivided into multiple blocks. In yet other embodiments, the
blocks may be performed in a different order than the order
described herein.
[0503] For example, in certain embodiments, the method of use
described herein further utilizes a process of detecting poor or
non-uniform HAS fluid evacuation (e.g., exsanguination) and tissue
contact with the heating element, such as can be achieved through
external compression. The detection process may include detecting
fluid evacuation and tissue contact with the associated heating
element by: measuring the ramp rate during heating; comparing
temperatures from multiple heat sensors along the heating element;
and/or determining the heating element temperature through RTD
detection of temperature by impedance and then comparing that
temperature to the temperature measured by at least one heat
sensor. Through such a detection process, the treatment system may
detect unfavorable conditions, such as, for example, the absence or
release of external compression and/or a portion of the heating
element being positioned within an introducer sheath. In yet other
embodiments, the thermal environment of the heating element may be
detected through providing an initial power pulse to the heating
element and then measuring the rate of temperature decay. Such a
characterization of the thermal environment may also advantageously
be used to detect if the heating element is positioned outside the
patient, such as during an accidental start before the catheter has
been properly inserted into the HAS.
[0504] In certain embodiments, a boiling sensor may also be
integrated into the catheter device, such as by providing at least
two electrodes on the exterior of the catheter and then measuring
the resistance to current flow between the two electrodes (e.g., to
indicate an air gap). In such embodiments, the power delivered by
the generator may be adjusted relative to the indication of
boiling, such as by reducing the delivered power when boiling
occurs.
[0505] It will also be understood that, in certain embodiments, one
or more blocks of the flowcharts illustrated in FIGS. 34A-34C may
be implemented by computer program instructions. For instance, the
computer program instructions may be provided to a processor of the
RF generator or other treatment device power source, a general
purpose computer, special purpose computer, or other programmable
data processing apparatus, such that the instructions, which
execute via the processor of the RF generator, power source,
computer or other programmable data processing apparatus, create
means for implementing the acts specified in the flowchart blocks.
In certain embodiments, the blocks may be executed by one or more
modules that comprise logic embodied in hardware or firmware of the
RF generator, computer, etc., or in software stored in the RF
generator, power source, computer, etc. It will be further
appreciated that hardware modules may comprise connected logic
units, such as gates and flip-flops, and/or may comprise
programmable units, such as programmable gate arrays or
processors.
[0506] The computer program instructions may also be stored in a
computer-readable medium that can direct the RF generator, power
source, a computer or other programmable data processing apparatus
to operate in a particular manner, such that the instructions
stored in the computer-readable medium produce an article of
manufacture including instruction means which implement the acts
specified in the flowchart blocks.
[0507] FIGS. 34A-B thus illustrate one embodiment of a method of
facilitating the treatment of a hollow anatomical structure. The
method involves (A) initiating power delivery to an energy
application device of a hollow anatomical structure treatment
device; (B) measuring an operating parameter of the treatment
device, the operating parameter being relevant to energy coupling
between the energy application device and its surroundings; (C)
determining whether the operating parameter satisfies a first
energy coupling condition within a first time interval following
the initiating; and (D) if the operating parameter does not satisfy
the first energy coupling condition within the first time interval,
providing a warning.
[0508] In variations of this method of facilitating treatment, the
measured operating parameter can be any one or combination of the
following: the temperature of at least a portion of the treatment
device; the temperature of at least a portion of the energy
application device; and/or the power delivered to the energy
application device. Where power is delivered to the energy
application device by electric current, the measured operating
parameter can be any one or combination of the following: the
electrical power delivered to the energy application device; the
magnitude of the electric current delivered to the energy
application device; and/or the electrical impedance of the energy
application device. Where power is delivered to the energy
application device by electric current, the energy application
device can comprise a conducting coil.
[0509] In further variations of this method of facilitating
treatment, where the measured operating parameter is the
temperature of at least a portion of the energy application device,
the first energy coupling condition can comprise meeting or
exceeding a first target temperature value for the temperature of
at least a portion of the energy application device; or meeting or
exceeding the first target temperature value within a prescribed
period of time after initiating power delivery. In FIG. 34B,
examples of this are shown in Block 734, where the process checks
for a target temperature (100 degrees C.) within a prescribed time
period (3 seconds) after initiation of power delivery; in Block
738, where the process checks for a different target temperature
(the "set" temperature which can be a desired treatment
temperature; in this case, 120 degrees C.) within a prescribed time
period (6 seconds) after initiation of power delivery; and in Block
742, where the process checks for a different target temperature
(approximately the set temperature) within a prescribed time period
(6 seconds) after initiation of power delivery.
[0510] In further variations of this method of facilitating
treatment, where the measured operating parameter is the
temperature of at least a portion of the energy application device,
the first energy coupling condition can comprise the absence of
sudden, relatively large changes to the temperature of at least a
portion of the energy application device. This particular variation
provides a method of or involving detecting sudden insufficient
compression of the portion of the HAS in which the energy
application device is positioned (or detecting the removal of
compression of the HAS), which increases fluid flow around the
energy application device and thereby drains heat from the energy
application device.
[0511] In further variations of this method of facilitating
treatment, where the measured operating parameter is the power
delivered to the energy application device, the first energy
coupling condition can comprise a delivered power magnitude which
is substantially similar to a reference waveform of expected power
magnitude; and/or a rate of change of the magnitude of power
delivered to the energy application device which is substantially
similar to a reference waveform of expected power delivered after
achievement of a target temperature value. To implement checking
for these energy coupling conditions, a reference waveform
(indicating magnitude vs. time) of expected power magnitude can be
stored in memory accessible to the power source (e.g. RF generator)
processor. The delivered power magnitude, and/or a rate of change
thereof, can be monitored, either continuously, intermittently, or
at selected "checkpoints," and compared to the reference waveform.
Substantial similarity (e.g. deviating no more than 1%, 5%, or 10%
at any point, in various embodiments) to the reference waveform
indicates normal power-up or operation of the energy application
device. In the variation where the energy coupling condition is a
delivered power magnitude substantially similar to the reference
waveform, this particular variation provides a method of or
involving detecting power-up of the energy application device in
air, the absence or insufficiency of local HAS compression at the
initiation of power delivery, and/or the absence or insufficiency
of local HAS compression later during power delivery, as these
conditions are associated with improper delivered power magnitude.
In the variation where the energy coupling condition is a rate of
change of delivered power magnitude substantially similar to the
reference waveform, this particular variation provides a method of
or involving detecting removal or insufficiency of local HAS
compression, and/or movement of the energy application device
during heating, as these conditions are associated with improper
delivered power magnitude.
[0512] In further variations of this method of facilitating
treatment, where the measured operating parameter is the electric
current delivered to the energy application device, the first
energy coupling condition can comprise a delivered electric current
magnitude which is substantially similar to a reference waveform of
expected electric current magnitude; and/or a rate of change of the
magnitude of electric current delivered to the energy application
device which is substantially similar to a reference waveform of
expected electric current delivered after achievement of a target
temperature value. To implement checking for these energy coupling
conditions, a reference waveform (indicating magnitude vs. time) of
expected electric current magnitude can be stored in memory
accessible to the power source (e.g. RF generator) processor. The
delivered electric current magnitude, and/or a rate of change
thereof, can be monitored, either continuously, intermittently, or
at selected "checkpoints," and compared to the reference waveform.
Substantial similarity (e.g. deviating no more than 1%, 5%, or 10%
at any point, in various embodiments) to the reference waveform
indicates normal power-up or operation of the energy application
device.
[0513] In further variations of this method of facilitating
treatment, where the measured operating parameter is the electrical
impedance of the energy application device, the first energy
coupling condition comprises a measured electrical impedance
magnitude which is substantially similar to a reference waveform of
expected electrical impedance of the energy application device;
and/or a measured rate of change of the magnitude of the electrical
impedance of the energy application device which is substantially
similar to a reference waveform of expected electrical impedance of
the energy application device. To implement checking for these
energy coupling conditions, a reference waveform (indicating
magnitude vs. time) of expected electrical impedance magnitude can
be stored in memory accessible to the power source (e.g. RF
generator) processor. The electrical impedance magnitude, and/or a
rate of change thereof, can be monitored, either continuously,
intermittently, or at selected "checkpoints," and compared to the
reference waveform. Substantial similarity (e.g. deviating no more
than 1%, 5%, or 10% at any point, in various embodiments) to the
reference waveform indicates normal power-up or operation of the
energy application device.
[0514] In further variations of this method of facilitating
treatment, if the operating parameter does not satisfy the first
energy coupling condition within the first time interval, power
delivery to the energy application device is reduced or terminated.
In FIG. 34B, examples of this are shown in Block 734, where failure
to satisfy the first energy coupling condition (temperature above
100 degrees C.) during a time interval (within 3 seconds after
initiation of power delivery) can lead to power shutdown in Block
744; and in Blocks 738 and 742, which also set forth energy
coupling conditions (target temperatures) and time intervals
(within 6 seconds after initiation of power delivery), wherein
failure to satisfy the coupling condition in the specified time can
also lead to power shutdown in Block 744.
[0515] In further variations of this method of facilitating
treatment, the warning provided (if the measured operating
parameter does not satisfy the first energy coupling condition
within the first time interval) comprises a message to adjust the
environment of the hollow anatomical structure treatment device
within the patient. Examples of this are shown in Blocks 736 and
754. Accordingly, one variation of the message can instruct a user
to adjust or improve compression of the portion of the hollow
anatomical structure containing the treatment device.
[0516] Further variations of this method of facilitating treatment
can also involve: determining whether the operating parameter
satisfies a second energy coupling condition within a second time
interval following the first time interval; and, if the operating
parameter does not satisfy the second energy coupling condition
within the second time interval, providing a warning. Examples of
this are shown in Blocks 738, 742 and 752. Still further variations
of this method can also involve terminating or reducing power
delivery to the energy application device if the operating
parameter does not satisfy the second energy coupling condition
within the second time interval. An example of this is shown in
Block 744.
[0517] Further variations of this method of facilitating treatment
can also involve taking corrective measures such as any one or more
of the following: applying compression in the vicinity of the
hollow anatomical structure containing the energy application
device; adjusting the location or force of existing compression in
the vicinity of the hollow anatomical structure containing the
energy application device; and/or verifying effective occlusion of
flow within the hollow anatomical structure in the vicinity of the
energy application device.
[0518] In further variations of this method of facilitating
treatment,- the energy application device comprises a resistance
temperature device; the method further comprises computing a
temperature of the energy application device based on the
electrical impedance of the energy application device; and the
first energy coupling condition comprises correlation of the
measured temperature of the energy application device to the
computed temperature of the energy application device. This
particular variation provides a method of or involving detecting
the presence of non-uniform temperature of the energy application
device, and/or detecting non-uniform or inadequate local HAS
compression, as these conditions are associated with lack of
correlation between measured temperature and computed temperature
of the energy application device.
[0519] In view of FIGS. 34A-B and the disclosure of treatment
devices such as the catheters 202, 202', 900 and 950, one
embodiment of apparatus for use in treating a hollow anatomical
structure comprises: (A) an energy application device adapted to
receive power from a power source; (B) a measuring device that
measures an operating parameter of the energy application device,
the operating parameter being relevant to energy coupling between
the energy application device and its surroundings; (C) a module in
communication with the measuring device, the module configured to
determine whether the operating parameter satisfies a first energy
coupling condition within a first time interval following the
initiation of power delivery to the energy application device; and
(D) a warning device in communication with the module, the module
further configured to cause the warning device to provide a warning
if the operating parameter does not satisfy the first energy
coupling condition within the first time interval.
[0520] In various embodiments, the energy application device can
comprise any of the heating elements, electrodes, therapeutic
devices, etc. disclosed herein, including but not limited to the
resistive element 14, the heating element 208, or therapeutic
element 280; or a laser, fluid-conducting heat exchanger, chemical
reaction chamber or any other device suitable to impart energy to
an HAS. The measuring device can comprise a thermocouple, a
thermistor, an RTD (which can be the energy application device
itself where the energy application device is an electrically
driven coil or other electrically driven heating element), a
photodetector, an ammeter, ohm meter, volt meter; or hardware or
software components of the treatment power source, RF generator,
computer, etc. The module can comprise hardware such as a treatment
power source, RF generator, computer, etc., or software executing
on any of these devices, or firmware, or a combination of hardware,
software and/or firmware.
[0521] FIG. 34A thus illustrates one embodiment of a method
comprising: (A) sensing a temperature on or near at least a portion
of a heat application device of a hollow anatomical structure
treatment device; (B) determining whether the temperature satisfies
a required initial temperature condition; (C) receiving a request
to initiate power delivery to the heat application device of the
hollow anatomical structure treatment device; and (D) if the
temperature does not satisfy the required initial temperature
condition, performing a safety procedure to interrupt a normal
power-up process for the heat application device.
[0522] As one example of determining whether the sensed temperature
satisfies a required initial temperature condition, in Block 718
the process checks for the presence of a low temperature flag,
which remains raised until the required initial temperature
condition (in this case, having sensed a temperature above 33
degrees C. since the catheter was plugged in, and/or currently
sensing a temperature above 33 degrees C.) has been satisfied. As
examples of receiving a request to initiate power delivery, Block
716 mentions two alternatives: sensing the press of a power
activation button on the catheter handle, or sensing the press of a
Start RF Treatment button or "softkey" on the power source. As an
example of performing a safety procedure, Blocks 722-726 show the
disabling of therapeutic power delivery start-up, the display of a
low temperature warning and prompt for the user to insert (or
verify insertion of) the energy application device, and the actions
to be taken if the user presses the power activation button on the
catheter or power source, or a cancel button.
[0523] One variation of this method involves allowing a normal
power-up process for the heat application device to proceed, if the
sensed temperature satisfies the required initial temperature
condition. One example of this is shown in Blocks 718-720, wherein
device power-up proceeds if the low temperature flag is not
raised.
[0524] In another variation of this method, determining whether the
temperature satisfies a required initial temperature condition
comprises determining whether the temperature has satisfied the
required initial temperature condition at any time during a
temperature sensing period. The temperature sensing period can
begin after connection of the treatment device to a power source
(Block 704), and/or end before delivery of therapeutic energy from
the power source to the treatment device (Block 720).
[0525] In further variations of this method, the safety procedure
can comprise preventing the initiation of power delivery to the
heat application device (e.g., Blocks 722-724), and/or ceasing the
delivery of power to the heat application device.
[0526] In further variations of this method, the required initial
temperature condition can be that the sensed temperature meet or
exceed a minimum temperature. The minimum temperature can be any
one or more of: significantly above an expected ambient room
temperature; substantially at an expected internal temperature of
the hollow anatomical structure to be treated with the treatment
device; and/or 5 to 10 degrees Celsius lower than the normal
physiologic internal temperature of a hollow anatomical structure
of the type normally treated with the treatment device.
[0527] In further variations of this method, the required initial
temperature condition can be that the sensed temperature fall
within an acceptable temperature range. The acceptable temperature
range can be any one or more of: significantly above an expected
ambient room temperature; bracketing an expected internal
temperature of the hollow anatomical structure to be treated with
the treatment device; and/or bracketing a temperature which is 5 to
10 degrees Celsius lower than the normal physiologic internal
temperature of a hollow anatomical structure of the type normally
treated with the treatment device.
[0528] Further variations of this method comprise providing a
warning if the sensed temperature does not satisfy the required
initial temperature condition. One example of this is seen in Block
722.
[0529] Further variations of this method comprise verifying that
the heat application device is properly disposed within a hollow
anatomical structure of a patient; and manually overriding the
safety procedure and initiating a power-up process for the heat
application device. One example of this is seen in Block 724.
[0530] In view of FIGS. 34A-B and the disclosure of treatment
devices such as the catheters 202, 202', 900 and 950, one
embodiment of apparatus for use in treating a hollow anatomical
structure comprises: (A) a heat application device adapted to
receive power from a power source; (B) a user interface adapted to
receive a request from a user to initiate power delivery to the
heat application device; (C) a temperature measuring device for
measuring a temperature within or near the heat application device;
(D) a module in communication with the temperature measuring device
and the user interface, the module configured to determine whether
a temperature measured by the temperature measuring device
satisfies a required initial temperature condition; wherein the
module is further configured to follow a safety procedure to
interrupt a normal power-up process for the heat application device
if the temperature measured by the temperature measuring device
does not satisfy the required initial temperature condition.
[0531] In various embodiments, the heat application device can
comprise any of the heating elements, electrodes, therapeutic
devices, etc. disclosed herein, including but not limited to the
resistive element 14, the heating element 208, or therapeutic
element 280; or a laser, fluid-conducting heat exchanger, chemical
reaction chamber or any other device suitable to impart heat energy
to an HAS. The temperature measuring device can comprise a
thermocouple, a thermistor, an RTD (which can be the energy
application device itself where the energy application device is an
electrically driven coil or other electrically driven heating
element), or a photodetector; or hardware or software components of
the treatment power source, RF generator, computer, etc. The module
can comprise hardware such as a treatment power source, RF
generator, computer, etc., or software executing on any of these
devices, or firmware, or a combination of hardware, software and/or
firmware.
[0532] FIG. 35 illustrates a graph 800 of exemplary embodiments of
power, time, and temperature measurements that may be encountered
during the treatment of a HAS of a patient. As illustrated, the
x-axis of the graph 800 plots a time (in seconds) of the treatment
process. The left y-axis of the graph 800 displays the temperature
values of the catheter (in .degree. C.) and power values of the
generator (in Watts). The right y-axis of the graph 800 illustrates
the impedance values of the heating element of the catheter device
(in Ohms) throughout the treatment.
[0533] As can be seen, the graph 800 comprises a temperature curve
802, a power curve 804 and an impedance curve 806 that each depicts
measurements during five treatments of a patient. In particular,
the graph 800 illustrates a treatment that initiates approximately
at a time 20 seconds. At this point, the power delivered by the
generator is ramped up to forty Watts, which causes a corresponding
increase in the temperature of the catheter device (e.g., to
approximately 120.degree. C.). In certain embodiments, the catheter
device reaches a target temperature of approximately 120.degree. C.
about 1.7 seconds after the power delivery is initiated.
[0534] After approximately six seconds, the power delivered by the
generator is reduced to twenty-five Watts, while the temperature of
the device remains at approximately 120.degree. for approximately
fourteen more seconds. Thus, the graph 800 illustrates, for
example, that to maintain a target temperature of 120.degree., the
generator need not maintain a constant power output of 40 watts
once the catheter device has reached the set (target) temperature.
As can also be seen from the graph 800, the impedance of the
catheter device has a direct relationship to the device
temperature. That is, as the temperature of the catheter device
(e.g., heating coil) increases, so does the impedance of the
catheter device. In certain embodiments, the graph 800 is
indicative of a use of a catheter device having a heating coil made
of Alloy 52.
[0535] The graph 800 also illustrates a double treatment of the
first portion of a HAS, which is shown by reference numeral 810. In
particular, the double treatment includes a re-application of power
at a time of approximately 45 seconds such that the temperature of
the catheter device does not cool to body temperature between
successive treatments. Rather, the temperature of the catheter
device drops to approximately 65.degree. C., at which point power
delivery is re-initiated. The temperature of the catheter device
increases again to approximately 120.degree. C. The graph 800 also
illustrates a third treatment 820, a fourth treatment 830, and a
fifth treatment 840. In certain embodiments, the third through
fifth treatments 820, 830 and 840 correspond to treatments in
different segments of the target HAS.
[0536] Accordingly, the graph 800 can be considered to depict a
method of treating an HAS in which multiple treatments are
administered to the HAS. The first treatment 810 is performed at
the distal-most treatment location within the HAS, and the second
through fourth treatments 820, 830, 840 are performed at
successively more proximal locations, as the catheter is moved
proximally between each treatment. As depicted, the first treatment
810 can involve applying energy to the first treatment location in
the HAS at two (or more) distinct times, and the subsequent
treatments 820, 830, 840, etc. can involve applying energy to the
subsequent treatment locations within the HAS only once.
Alternatively, multiple distinct energy applications can be
employed in any one or more of the subsequent treatments. Whether
one or multiple energy applications are employed in the first
treatment 810 (or in the subsequent treatments 820, 830, 840), in
certain embodiments, the treatment method depicted by the graph 800
can comprise applying energy to the first treatment location in the
HAS (in the first treatment 810) for a longer total duration than
to any one of the subsequent treatment locations (in the subsequent
treatments 820, 830, 840). This can be done in treatment situations
where the HAS has a larger cross-sectional profile, as viewed along
a longitudinal axis of the HAS, in the first treatment location
than in any one of the subsequent treatment locations. Such a
situation is often encountered when treating the GSV as depicted in
FIGS. 16A-l 6D, when the catheter is drawn proximally from the SFJ
as the treatment progresses. In this type of GSV treatment, the
first treatment location (the site of the first treatment 810) is
closer to the SFJ than is any of the subsequent treatment
locations.
[0537] FIG. 36A illustrates an embodiment of a catheter system 900
usable to treat a HAS of a patient, such as, for example, according
to the treatment methods described herein. The catheter system 900
includes a heating element 910, which may comprise any of the
heating elements or therapeutic elements described herein. Thus, in
various embodiments, the heating element 910 can comprise any of
the devices disclosed herein as suitable for use as the resistive
element 14, heating element 208 or the therapeutic element 280. The
catheter system 900 also includes indexing marks 912 to assist in
the positioning of the heating element 910 during successive
treatments of the patient. Warning lines 914 are also included on
the catheter shaft to indicate to a user the last treatment of the
catheter (e.g., to prevent power delivery while the heating element
is in an introducer sheath). The catheter system 900 also includes
adjustable markers 916 and a strain relief 920.
[0538] As is further depicted in FIG. 36A, a luer adaptor 922 is
positioned on the proximal end of the catheter system 900. In
certain embodiments, the luer adaptor is in fluid communication
with an internal lumen of the catheter, allowing for delivery of
fluid and/or passage of a guidewire. The system 900 further
includes an integrated cable 924 with an instrument cable connector
926 that couples to a generator, such as one of the RF generators
disclosed herein.
[0539] FIG. 36B illustrates a catheter system 950 similar to the
catheter system 900 of FIG. 36A. The catheter system 950 includes a
heating element 960, indexing marks 962, and warning lines 964 to
indicate the final treatment section of the catheter. In various
embodiments, the heating element 960 can comprise any of the
devices disclosed herein as suitable for use as the resistive
element 14, heating elements 208 or 910, or the therapeutic element
280. The catheter system 950 also includes adjustable markers 966,
a strain relief 970, a luer adaptor 972, an integrated cable 974,
and an instrument cable connector 976. The catheter system 950
further includes a start/stop switch 980. In certain embodiments,
the start/stop switch 980 allows a user to control the delivery of
RF power to the heating element 960 without having to activate a
control on an associated RF generator.
[0540] In certain embodiments, it may also be advantageous to limit
the number of times that a catheter device is clinically used. For
example, one or more methods may be employed by which the power
generator detects how many times a catheter has been used. For
instance, in certain embodiments, the catheter device may
incorporate a smart electronic signature or a radio frequency
identification (RFID) tag (such as, for example, in the handle). In
other embodiments, the catheter device may comprise an identifying
resistor with a fuse that is shorted by the initial energy
delivery. In such embodiments, the generator and/or computing
device associated therewith may maintain in memory data that
identifies that an unused device has been used for the first time
and that allows the device (a used device) to be used for a
particular period of time.
[0541] Except as further described herein, any of the catheters
disclosed herein may, in some embodiments, be similar to any of the
catheters described in U.S. Pat. No. 6,401,719, issued Jun. 11,
2002, entitled "METHOD OF LIGATING HOLLOW ANATOMICAL STRUCTURES;"
or in U.S. Pat. No. 6,179,832, issued Jan. 30, 2001, titled
"EXPANDABLE CATHETER HAVING TWO SETS OF ELECTRODES;" or in U.S.
patent application Ser. No. 11/222,069, filed Sep. 8, 2005,
entitled "METHODS AND APPARATUS FOR TREATMENT OF HOLLOW ANATOMICAL
STRUCTURES." In addition, any of the catheters disclosed herein
may, in certain embodiments, be employed in practicing any of the
methods disclosed in the above-mentioned U.S. Pat. Nos. 6,401,719
or 6,179,832, or the above-mentioned U.S. patent application Ser.
No. 11/222,069 filed Sep. 8, 2005. The entirety of each of these
patents and application is hereby incorporated by reference herein
and made a part of this specification.
[0542] For exemplary purposes, a method of treatment will now be
described with reference to embodiments of the treatment systems
described herein. In certain preferred embodiments, the treatment
method comprises endovascular vein treatment using a catheter with
an integrated heating element. The description of the treatment
method will be divided into three stages: a patient preparation
stage; a treatment stage and a follow-up stage. A skilled artisan
will recognize that the three different stages are for reference
purposes only and that, in other embodiments, the acts described
hereinafter may occur in different stages, in more than one stage,
and/or in a different order.
[0543] The treatment method begins with the patient preparation
stage. During this initial stage, a mapping of the veins intended
for treatment is performed. For instance, duplex ultrasound (DU)
imaging or other like methods may be used to map the vessels. In
certain embodiments, the mapping includes recording the diameters
of the veins for treatment. In certain embodiments, mapping further
includes noting the GSV track and depth, locations of significant
tributaries, aneurysmal segments and/or potential vein access
sites. An indelible marker may also be used to record particular
landmarks on the surface of the patient's skin. In certain
embodiments, the mapping is performed on the same day as the actual
vein treatment or may be performed prior to the treatment day.
[0544] Following mapping, a local anesthetic is optionally
administered at the vein access site. In certain embodiments, a
mild sedation may also be given to the patient. In certain
embodiments, it is also advantageous to avoid during this initial
stage certain factors (e.g., certain drugs, a cold environment,
patient anxiety, combinations of the same or the like) that may
induce venospasm, which may hinder the ability to access the target
vein.
[0545] The patient is then preferably positioned to facilitate vein
access, such as by positioning the patient so as to increase the
diameter of the target vein. For example, the patient's legs may be
positioned below the level of the patient's heart. As discussed in
more detail below, prior to and/or during treatment, the patient's
legs may then be moved to a horizontal position or preferably above
the level of the patient's heart to assist in reducing vein
diameter and/or reduce venous filling.
[0546] In certain embodiments, the physician accesses the target
vein via a percutaneous stick using, for example, an 18 gauge
(thin-walled) or a 19 gauge ultra thin-walled needle or via a small
cut-down. The physician then inserts an introducer sheath, such as,
for example, a seven-French introducer sheath with an
eleven-centimeter length, into the patient.
[0547] Prior to insertion of the catheter into the sheath, the
inner lumen of the catheter is preferably flushed with a
heparinized saline. The lumen is then capped, and the outer surface
of the catheter is wiped with saline, heparinized saline or other
like solution. Once the catheter is prepared and the introducer
sheath is properly positioned, the catheter is placed into the
introducer sheath, and the catheter tip is advanced to a point for
treating the target vein.
[0548] For example, in certain embodiments, the catheter may be
advanced to the saphenofemoral junction (SFJ), the tip of the
catheter being initially positioned just inferior to the osmium of
the superficial epigastric vein or, alternatively, one to two
centimeters distal to the SFJ. In certain embodiments, catheter
navigation to the treatment site may be performed using ultrasoud
guidance, palpation, and/or with a guidewire. For example, a 0.025
inch guidewire with a 150 or 260 centimeter length may be used to
navigate the catheter through the patient's venous anatomy. It may
also be advantageous to avoid advancing the catheter against
resistance from the vein so as to avoid vein perforation.
[0549] Following placement of the catheter, a local anesthetic may
be optionally administered, which may preferably include perivenous
tumescent anesthesia along the vein segment to be treated. In
embodiments in which the target vein is located near the skin
surface (e.g., less than one centimeter below the skin surface), a
sufficient subcutaneous distance between the vein and skin may be
created by tumescent infiltration of saline or dilute local
anesthetic solution. For instance, a 20 or 22 gauge, 3.5 inch long
spinal needle may be used for the tumescent fluid infiltration.
[0550] In certain embodiments, the treatment method further
includes using a tumescent infiltration of dilute local anesthetic
or saline into the perivascular space to create a circumferential
fluid layer around the vessel to be treated. For instance, a
sufficient volume of the fluid may be used to exsanguinate and/or
compress the vein to achieve apposition of the catheter heating
element and the vein wall. For example, the physician may-confirm
that the vein has been adequately compressed and that the tumescent
solution has infiltrated circumferentially around the vein by
scanning the entire treatment length with DU imaging.
[0551] In certain embodiments, the patient is advantageously placed
in the Trendelenburg position so that the leg with the target vein
is above the heart to facilitate vein collapse, apposition, and/or
exsanguination. In one embodiment, the treatment method further
includes partially withdrawing the introducer sheath until the
sheath hub and nearest catheter index line are aligned, while also
maintaining the catheter tip position. The physician then secures
the introducer sheath to the skin of the patient. In another
embodiment, a position datum is created in alignment with a
catheter index line, such as by drawing a line or placing a piece
of tape on the patient's skin.
[0552] In certain embodiments, the initial preparation stage of the
treatment method includes verifying the position of the catheter
tip using DU imaging or another appropriate method. For instance,
the physician may verify that the heating element of the catheter
is not positioned in the deep venous system. If a guidewire was
used to advance the catheter within the venous system, the
guidewire may then be removed.
[0553] The treatment stage follows the patient preparation stage.
To begin the treatment stage, and prior to energy delivery, the
physician preferably creates firm contact between the target vein
wall and the heating element by compressing the HAS segment to be
treated. For example, in certain embodiments, the physician may
manually apply pressure to the patient's leg in order to create the
desired contact. In other embodiments, the physician may wrap the
patient's leg with an elastomeric wrap (e.g., an Esmark bandage) to
create the desired contact along the full length of the catheter.
The treatment method may also advantageously comprise creating a
near-bloodless field for the catheter with little or no blood flow
past the heating element.
[0554] To obtain the near-bloodless field, the physician may
perform perivenous tumescent infiltration along with at least two
of the following: (1) exerting external compression along the
length of the heating element; (2) tightly wrapping the limb, such
as, for example, with an Esmark bandage; and (3) further
positioning the legs of the patient above the heart to facilitate
vein collapse, apposition and/or exsanguination. In certain
embodiments, the wrapping act need not be performed if a sufficient
volume of tumescent infiltration is used to exsanguinate the vein
and obtain apposition of the vein wall and catheter heating
element.
[0555] The physician then enables RF energy delivery by activating
an appropriate control (e.g., an "RF POWER" button) on the RF
generator. In certain embodiments, the generator includes an
indicator (such as a visual and/or audible indicator) to alert the
physician that the generator is ready to deliver energy. For
instance, the generator may include an RF control (e.g., an "RF
POWER" button) that blinks when energy delivery is enabled. In
certain further embodiments, if an error condition prevents energy
delivery from being enabled, the generator may further display an
error message, such as on a screen or like user interface.
[0556] Once energy delivery is enabled, the physician initiates
energy delivery by activating the appropriate generator control
(e.g., pressing a "Start RF" control on the generator) and/or
activating a control on the catheter handle (e.g., an optional
"START/STOP" button on the handle). RF energy delivery may be
automatically terminated by the generator when the treatment cycle
is complete, or alternatively the physician may terminate energy
delivery earlier by pressing the appropriate control(s) on the
generator and/or catheter handle.
[0557] Furthermore, in certain embodiments, the target vein is
advantageously compressed onto the full length, or substantially
full length, of the heating element during application of energy so
as to avoid inconsistent effectiveness and/or possible failure by
the catheter.
[0558] In certain embodiments, if a certain temperature is not
reached within a predetermined period of time (e.g., six seconds)
after initiation of the RF energy delivery, the treatment method
includes terminating the RF energy delivery, verifying the
effectiveness of flow occlusion and proper tip position, and
re-initiating treatment of the HAS segment. In such embodiments,
the inability to reach the set temperature within the predetermined
period of time may indicate that fluid flow or presence of fluid
within the vein is cooling the treatment segment. Furthermore,
continuous temperature readings below the set temperature may
result in incomplete treatment. If such occurs, the treatment
method may include stopping the treatment, reconfirming vessel
apposition to the catheter heating element, reconfirming the
absence of blood flow in the vessel segment to be treated, applying
more firm external compression if needed, and then retreating the
HAS segment.
[0559] Following the treatment time interval, the RF energy
delivery terminates automatically. The RF energy delivery may then
optionally be repeated in a given vein segment according to the
treatment procedures by the physician. Double-treatment, or
multiple treatments, of a vein segment may be desirable at the
first treatment nearest the SFJ, within an aneurismal vein segment,
or near a large sidebranch vessel. In certain embodiments of the
treatment method, it is preferable that the catheter is not
re-advanced through an acutely treated vein segment.
[0560] In certain embodiments, the RF energy delivery may result in
a target treatment temperature between approximately 100.degree. C.
and approximately 120.degree. C. (e.g., 100.degree. C., 110.degree.
C., or 120.degree. C.). The treatment time per vein segment may
have a duration of approximately ten seconds to approximately
thirty seconds (e.g., 10, 15, 20, 25, or 30 second intervals). In
certain preferred embodiments, a seven-centimeter vein segment is
treated at approximately 120.degree. C. for approximately twenty
seconds. Moreover, a 45-centimeter vein may be treated in
approximately three to five minutes.
[0561] After treatment of a particular segment is completed, the
treatment method comprises quickly withdrawing the catheter until
the next visible treatment index line is aligned with the hub of
the introducer sheath or other established datum. During such
withdrawal of the catheter, some friction may exist between the
vein wall and catheter after a heating cycle.
[0562] Once the catheter is re-positioned appropriately, the next
vein segment is treated in a manner similar to the treatment of the
first section. This process is repeated until all the vein segments
are treated. In certain embodiments, diagonal lines on the catheter
shaft are used to indicate the last full treatment segment (e.g.,
when the lines are visible outside the introducer sheath). In
certain embodiments, it is also advantageous to confirm that the
heating element is in the vein before the last treatment in order
to avoid energy delivery while the heating element is inside the
introducer sheath.
[0563] In certain embodiments, the treatment method further
comprises evaluating the treated vein segments to analyze the
treatment outcome. For example, the physician may utilize
ultrasound or other means to determine the extent of the treatment
of the vein by observing for reduced vein inner diameter,
thickening of the vein wall, and absence of blood flow or refluxing
blood flow.
[0564] When terminating the treatment stage, the physician disables
RF energy delivery by deactivating the appropriate control on the
RF generator (e.g., an "RF POWER" button), withdrawing the
catheter, removing the external compression, and obtaining
hemostasis at the access site.
[0565] After the treatment stage, the treatment process includes a
follow-up stage that comprises acts directed to facilitating and/or
expediting patient recovery. The follow-up stage may include
instructing the patient to ambulate frequently and/or to refrain
from strenuous activities or heavy lifting for several days.
Post-operative compression of the target limb is also recommended
for at least one week following the treatment.
[0566] In certain embodiments of the treatment process, a follow-up
examination is conducted within 72 hours of the treatment. Such an
examination may preferably include an assessment to ensure that
there is no thrombus extension into deep veins.
[0567] Although the foregoing treatment process has been with
respect to particular embodiments, in other embodiments, the acts
described herein may be combined, performed in a different order,
and/or may be omitted from the treatment process. Furthermore, in
certain embodiments, additional acts may be included in the
treatment process in order to assist in the treatment and/or
recovery of the patient.
[0568] Additional embodiments comprise methods of sterilization.
Certain such methods can comprise sterilizing, either terminally or
sub-terminally, any of the apparatus disclosed herein that are
intended for insertion into (or other contact with) the patient or
that are intended for use at or near the surgical field during
treatment of a patient. Any suitable method of sterilization,
whether presently known or later developed, can be employed.
[0569] Accordingly, certain methods comprise sterilizing, either
terminally or sub-terminally, any one or combination of the
following apparatus: the resistive element systems 10, 20 (with or
without a working end of the types depicted in FIGS. 4, 5-7A,
7C-7E, and 8-13B) and/or the catheters 11, 21 or sheath 22 thereof;
the HAS treatment system 200 and/or the catheters 202, 202' or
introducer sheath 204 thereof; the datum devices 230, 250 (with or
without a corresponding sheath 234/254 attached thereto); the HAS
indexing treatment device 270 and/or the catheter 272, introducer
hub 274 or outer sheath 277 thereof; the catheter shaft 290 with
markings 292; the catheter 304 with detents 302; the HAS treatment
system 310 and/or the catheter shaft 314 thereof; the HAS treatment
system 330; the indexing devices 350, 360, 370, 390; the indexing
system 430; the catheter handle 460; the catheter systems 900 and
950. Any suitable method of sterilization, whether presently known
or later developed, can be employed. For example, the method can
comprise sterilizing any of the above-listed apparatus with an
effective dose of a sterilant such as cyclodextrin (Cidex.TM.),
ethylene oxide (EtO), steam, hydrogen peroxide vapor, electron beam
(E-beam), gamma irradiation, x-rays, or any combination of these
sterilants.
[0570] The sterilization methods can be performed on the apparatus
in question while the apparatus is partially or completely
assembled (or partially or completely disassembled); thus, the
methods can further comprise partially or completely assembling (or
partially or completely disassembling) the apparatus before
applying a dose of the selected sterilant(s). The sterilization
methods can also optionally comprise applying one or more
biological or chemical indicators to the apparatus before exposing
the apparatus to the sterilant(s), and assessing mortality or
reaction state of the indicator(s) after exposure. As a further
option, the sterilization methods can involve monitoring relevant
parameters in a sterilization chamber containing the apparatus,
such as sterilant concentration, relative humidity, pressure,
and/or apparatus temperature.
[0571] In view of the foregoing discussion of methods of
sterilization, further embodiments comprise sterile apparatus.
Sterile apparatus can comprise any of the apparatus disclosed
herein that are intended for insertion into (or other contact with)
the patient or that are intended for use at or near the surgical
field during treatment of a patient. More specifically, any one or
combination of the following can be provided as a sterile
apparatus: the resistive element systems 10, 20 (with or without a
working end of the types depicted in FIGS. 5-7A, 7C-7E, and 813B)
and/or the catheters 11, 21 or sheath 22 thereof; the HAS treatment
system 200 and/or the catheters 202, 202', 202'' or introducer
sheath 204 thereof; the datum devices 230, 250 (with or without a
corresponding sheath 234/254 attached thereto); the HAS indexing
treatment device 270 and/or the catheter 272, introducer hub 274 or
outer sheath 277 thereof; the catheter shaft 290 with markings 292;
the catheter 304 with detents 302; the HAS treatment system 310
and/or the catheter shaft 314 thereof; the HAS treatment system
330; the indexing devices 350, 360, 370, 390; the indexing system
430; the catheter handle 460.
[0572] While certain embodiments have been described, these
embodiments have been presented by way of example only, and are not
intended to limit the scope of the disclosure. Indeed, the novel
methods and systems described herein may be embodied in a variety
of other forms; furthermore, various omissions, substitutions and
changes in the form of the methods and systems described herein may
be made without departing from the spirit of the disclosure.
[0573] A number of applications, publications and external
documents are incorporated by reference herein. Any conflict or
contradiction between a statement in the bodily text of this
specification and a statement in any of the incorporated documents
is to be resolved in favor of the statement in the bodily text.
* * * * *