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Claims  |
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What is claimed is:
1. A system for applying heat to a body site, the system comprising in
operative association:
(a) a medical device including an elongated light transmitting fiber having
a proximal end and a distal end, and a heat generating element defining a
cavity with vent means in flow communication with the cavity for
permitting gas to escape from the cavity, the element having a selectively
varying thickness and being mounted with respect to the distal end such
that light transmitted by the fiber to the element is converted into heat
by the element;
(b) a light source associated with the proximal end of the fiber for
providing sufficient light energy to raise the temperature of the element;
and
(c) temperature sensing means associated with the proximal end of the fiber
for measuring the temperature of the element.
2. The system of claim 1 wherein the light source is a laser.
3. The system of claim 1 wherein the temperature sensing means is a
pyrometer.
4. The system of claim 1 wherein the light source and temperature sensing
means are associated with the proximal end of the fiber by beam splitting
means.
5. The system of claim 1 including locking means for retaining the element
on the fiber.
6. The system of claim 1 wherein the medical device includes an elongated
tube carrying the fiber.
7. The system of claim 6 wherein the tube engages the heat generating
element to help retain the element on the fiber.
8. The system of claim 6 wherein the fiber is slidably received in the
tube.
9. The system of claim 6 wherein the tube carries blood flow occlusion
means.
10. The system of claim 1 wherein the heat generating element is formed as
a cylindrical member with a closed, rounded end having a selected
thickness, and a side wall with a thickness less than the thickness of the
end.
11. The system of claim 1 wherein the heat generating element includes a
selectively located peripheral notch formed therein to limit the transfer
of heat from the region distally of the notch to the region proximally
thereof.
12. A localized heat applying medical device for applying heat to a site in
a patient's lumen, the device comprising in operative association:
an elongated light transmitting conduit having a proximal end and a distal
end and a heat generating element defining a cavity with vent means
therein for permitting gas to escape from the cavity, the element being
mounted on the distal end such that light transmitted by the conduit to
the element is converted by the element into heat to raise the temperature
of the element and the element can then be contacted with material in the
patient's lumen to alter the material; the conduit and heat generating
element being adapted for insertion into the patient's lumen.
13. The medical device of claim 12 wherein the heat generating element is
made of metal.
14. The medical device of claim 12 wherein the conduit is a light
transmitting fiber.
15. The medical device of claim 14 wherein the distal end of the fiber is
received in the cavity defined by the heat generating element.
16. The medical device of claim 15 wherein the inside surface of the cavity
has been treated to increase its coefficient of emissivity.
17. The medical device of claim 12 wherein the exterior surface of the heat
generating element is provided with a coating of
poly(tetrafluoroethylene).
18. The medical device of claim 12 including locking means for retaining
the heat generating element on the distal end of the conduit.
19. The medical device of claim 18 wherein the locking means includes an
inwardly extending ridge on the element received in a groove defined by
the light transmitting conduit.
20. The medical device of claim 12 wherein the heat generating element has
a generally rounded exterior surface.
21. The medical device of claim 12 including an elongated tube having a
proximal portion and a distal portion, the tube carrying the light
transmitting conduit with the heat generating element beyond the distal
portion of the tube.
22. The medical device of claim 21 wherein the tube defines a fluid
passageway along its length.
23. The medical device of claim 22 further including centering means for
positioning the conduit generally along the central axis of the tube.
24. The medical device of claim 21 including blood flow occlusion means
carried by the tube adjacent the distal portion.
25. The medical device of claim 21 wherein the tube engages the element to
help retain the element on the conduit.
26. The medical device of claim 21 wherein the light transmitting conduit
is slidably carried by the tube.
27. The medical device of claim 12 wherein the light transmitting conduit
is flexible.
28. The device of claim 12 wherein the heat generating element is elongated
with a closed, rounded end having a selected thickness and a side wall
with a thickness less than the thickness of the end.
29. The device of claim 28 wherein the heat generating element includes a
peripheral notch formed therein to limit heat transfer from the region
distally of the notch to the region proximally thereof.
30. A localized heat applying medical device for applying heat to a site,
the device comprising in operative association:
(a) a flexible elongated light transmitting fiber having a proximal end and
a distal end, the distal end adapted to emit light transmitted by the
fiber;
(b) a metal heat generating element insertable into a lumen and defining a
cavity into which the distal end of the fiber is positioned and a light
receiving surface adapted to collect light emitted by the distal end of
the fiber, the element converting the light into heat, the element having
vent means in flow communication with the cavity for permitting gas to
escape from the cavity; and
(c) means for mounted the element onto the distal end of the fiber such
that light emitted by the distal end is received on the surface of the
element, the mounting means including at least one inwardly extending
peripheral ridge on the element which lockingly engages a corresponding
groove defined by the fiber.
31. The medical device of claim 30 wherein the light receiving surface of
the cavity has been treated to increase its coefficient of emissivity.
32. The medical device of claim 30 including an elongated tube having a
proximal portion and a distal portion, the tube carrying the light
transmitting fiber with the heat generating element beyond the distal
portion of the tube.
33. The medical device of claim 32 including an inflatable balloon carried
circumferentially about the tube adjacent the distal portion of the tube.
34. The medical device of claim 32 wherein the distal portion of the tube
engages the heat generating element.
35. The medical device of claim 34 wherein the tube defines a fluid
passageway along its length and the element defines at least one flute in
fluid communication with the passageway and opening outside the element.
36. The medical device of claim 32 wherein the fiber is slidably received
in the elongated tube.
37. The medical device of claim 36 wherein the tube includes three ridges
extending into the fluid passageway and centering the conduit within the
passageway.
38. The medical device of claim 31 further including an inflatable balloon
carried circumferentially about the tube adjacent the distal protion of
the tube, the interior of the balloon in fluid communication with a
channel defined by one of the ridges.
39. The medical device of claim 30 wherein the heat generating element is
elongated with a closed, rounded end having a selected thickness and a
side wall with a thickness less than the thickness of the end.
40. The medical device of claim 39 wherein the heat generating element
includes a peripheral notch formed therein to limit heat transfer from the
region distally of the notch to the region proximally thereof.
41. A medical device for applying heat to a site in a patient's body, the
device comprising in operative association;
(a) an elongated tube having a distal portion and defining a fluid
passageway along its length;
(b) an elongated light transmitting fiber slidably carried by the tube in
the passageway, the fiber having a proximal end and distal end; and
(c) a metal heat generating element mounted on the distal end of the fiber
such that light transmitted through the fiber is converted by the element
to heat, the element defining a cavity therein bounded in part by a
closed, rounded end of a selected thickness and a sidewall of a thickness
less than the thickness of the end, the element having vent means in flow
communication with the cavity for permitting gas to escape from the
cavity, the element being extendable beyond the distal portion of the
tube.
42. medical device of claim 41 including an inflatable balloon carried
circumferentially about the tube adjacent the distal portion of the tube.
43. The medical device of claim 41 wherein the element has a cross section
greater than the cross section of the passageway defined by the tube.
44. The medical device of claim 41 including locking means for retaining
the heat generating element on the distal end of the fiber.
45. The medical device of claim 41 wherein the distal end of the fiber is
received in said cavity defined by the heat generating element.
46. The medical device of claim 45 wherein the inside surface of the cavity
has been treated to increase its coefficient of emissivity.
47. The medical device of claim 41 wherein the exterior surface of the heat
generating element is provided with a coating of
poly(tetrafluoroethylene).
48. The medical device of claim 41 wherein the heat generating element
includes a peripheral notch formed therein to limit heat transfer from the
region distally of the notch to the region proximally thereof.
49. A method for removing at least a portion of material causing a
constriction or obstruction in a lumen, the method comprising the steps
of:
(a) providing a medical device having a heat generating element mounted on
the distal end of an elongated light transmitting fiber;
(b) positioning the distal end of medical device within the lumen with the
element in contact with the material;
(c) transmitting light energy through the fiber such that the element
becomes sufficiently hot to soften the material; and
(d) moving the element into the material so as to form or enlarge a channel
in the material.
50. The method of claim 49 including the step of introducing a liquid into
the lumen before light transmission.
51. The method of claim 50 including the step of introducing a
physiologically compatible gas into the lumen about the element after the
liquid has been introduced but before light transmission.
52. The method of claim 51 including the step of occluding the lumen prior
to introducing the liquid.
53. The method of claim 50 wherein the liquid is a radiopaque liquid.
54. The method of claim 49 including the step of introducing a gas into the
lumen about the element prior to light transmission.
55. The method of claim 54 wherein the gas is carbon dioxide.
56. The method of claim 49 wherein the light transmission begins before the
element is contacted with the material.
57. The method of claim 49 including producing the light energy to be
transmitted with a laser.
58. The method of claim 49 including the additional step of measuring the
temperature of element after light transmission.
59. The method of claim 58 wherein the temperature of the element is
measured with a pyrometer. |
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Claims  |
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Description  |
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TECHNICAL FIELD OF THE INVENTION
This invention relates to medical devices and procedures for applying
localized heat to a site in a patient's body for such purposes as removing
tissue or deposits or cauterizing tissue.
BACKGROUND OF THE INVENTION
Providing localized heat to a site in a patient's body has often been used
to cauterize a lesion to stop bleeding. Localized heat can also be used to
alter, remove, or destroy tissue in a patient's body. One example of such
localized heating is the treatment of a bleeding ulcer. An endoscope is
inserted through a patient's esophagus to view the bleeding site and
direct an electric powered heating element to contact the site and
cauterize the bleeding. Another example is the use of such heat to remove
neoplastic pulmonary tissue.
Unfortunately, electric heating elements can be difficult to manipulate and
generally heat up relatively slowly. The heating rate and maximum
sustainable temperature is limited by the electric current available to
the element. The available current in turn is limited by the size of the
wires leading to the element. Wire size limits access to body sites for
two reasons: larger wires cannot be inserted into small areas and
increased wire size also means a loss of flexibility.
The electric current passing through the wires also limits the regions in
the body in which such a device can be used. There is the threat of an
electric shock to the patient and the generated electric field about the
wires by flowing current can also have undesirable effects. One region
where such electric currents and fields could possibly be life threatening
is in the heart.
One proposal which heats the end of an endscope to avoid dew forming on a
window is shown in U.S. Pat. No. 4,279,246 to Chikama. That device heats
the window to about body temperature to prevent dew formation. However,
due to the design of the device, the heat generated on the window is
limited to about body temperature and therefore could not be used to alter
or destroy tissue.
Cardiovascular disease continues to be an ongoing problem, particularly in
complex societies. It has been estimated that every year more than
one-half million Americans die from cardiovascular disease. Another 3.5
million are believed to suffer some degree of incapacitation because of
this disease. A particularly serious problem is the progressive blockage
of a blood vessel by the collection or deposit of fatty material such as
arteriosclerotic plaque. The collected material at first constricts the
vessel, reducing blood flow to a relatively small channel. Eventually,
blood flow can be obstructed completely.
Various devices and methods have been proposed in an attempt to deal with
obstructed or constricted blood vessels. In one method, a balloon is
positioned within the constricted channel and inflated, compressing the
plaque into the vessel walls to widen the opening. This method is only
available when the constriction in the blood vessel is not so severe that
the remaining channel is too small for the deflated balloon. Compression
of the plaque into the vessel walls is not possible where the plaque has
become calcified and hard. Such a method is not even attempted in
completely obstructed vessels.
Accordingly, it would be desirable to provide a method and device which
avoids the shortcomings of the prior art yet provides an effective means
for delivering localized heat to a site within a patient's body. The heat
provided by such a device can be used to stop bleeding or remove body
tissue or material in a blood vessel, even a completely obstructed blood
vessel. For such a device, the heat should be quickly developed without
use of electrical current. Also, the device should be sufficiently small
so that it can be directed into a patient's body cavity or lumen such as a
blood vessel. It would also be desirable to provide rapid and accurate
measurement of the heat produced. The present invention meets these
desires.
SUMMARY OF THE INVENTION
The present invention contemplates a medical device, system and method for
applying localized heat to a site in a patient's body. The localized heat
provided in accordance with the present invention can be used for several
purposes such as cauterizing a lesion to stop bleeding, or to remove a
clot, or to remove an arteriosclerotic deposit from a blood vessel. The
heat available can also be used to create an open channel in a previously
occluded blood vessel.
Generally, the medical device embodying this invention includes a heat
generating element mounted on the distal end of an elongated light
transmitting conduit. A preferred conduit is a single flexible quartz
optical fiber. Light energy from an intense light source such as a laser
is transmitted through the conduit and emitted onto a light receiving
surface of the heat generating element. The light is converted by the
element to generate heat. The element can then be contacted with a
material in a patient's body such as a clot, deposit or tissue to alter
that material by melting, removing or destroying it. The heat generating
element preferably has a rounded exterior surface end and is retained on
the conduit by a locking means, such as a ridge on the element received in
a complementary groove on the conduit.
Since light is used to transfer energy to the heat generating element,
there are no electrical currents present which could possibly threaten the
patient. Also, far more energy can be conducted by light through an
optical fiber than by electricity through wires of the same diameter. The
use of an intense light from a laser allows a substantial amount of energy
to be rapidly transferred to the heat generating element for rapid
heating. This avoids the difficulties inherent in electrical systems,
including the presence of electrical currents and the relatively slow
heating of the element.
The medical device can be used as part of a system which also includes a
light source for providing sufficient light energy to raise the
temperature of the element to soften the deposit in a blood vessel, and
temperature sensing means associated with the light transmitting conduit
for monitoring the temperature of the element. The preferred light source
is a laser and the preferred temperature sensing means is a pyrometer.
Other such means can be utilized, however. The laser is activated to
transmit an intense light pulse through the conduit. The light is emitted
by the conduit onto the receiving surface of the heat generating element
which converts the light energy into heat. After the laser is deactivated,
the light or glow from the hot element is transmitted back through the
light transmitting conduit. This glow is then converted by the pyrometer
into a temperature reading or measurement.
The medical device can also be provided with an elongated tube which
carries the light transmitting conduit. The heat generating element
extends beyond the distal portion of the tube so it may be brought into
contact with the tissue or deposit to be heated. The tube helps guide the
conduit to the desired location and is particularly useful for providing
access to a blood vessel. The exterior of the tube can be provided with
blood flow occlusion means such as an inflatable balloon to selectively
stop the flow of blood. A fluid such as saline, a radiopaque liquid or
carbon dioxide can also be introduced through a passageway defined by the
tube.
A viewing system to permit viewing within the lumen or blood vessel can
also be provided as part of the medical device. Generally, the viewing
system includes a fiberoptic viewing bundle carried by the tube to provide
a view of the heat generating element and the tissue or obstruction about
to be contacted. A suitable clear flushing fluid can be introduced through
the passageway defined by the tube to provide improved viewing.
In use, the medical device is inserted into a patient's body such as by
positioning the distal end of the medical device within a blood vessel.
The element is contacted with a site such as a constriction, and light
energy is transmitted through the conduit to heat the element rapidly and
sufficiently to soften and open at least a portion of the constriction as
the element contacts the constriction and is urged forward. In one
preferred method aspect, the blood flow is occluded by the balloon and a
radiopaque liquid introduced into the vessel to allow fluoroscopic study
of the constriction and location of the medical device. It is particularly
preferred also to introduce a bubble of biologically compatible gas such
as carbon dioxide into the vessel about the element prior to the light
transmission. This avoids dissipation of heat into the liquid or blood
otherwise in contact with the element.
Numerous other advantages and features of the present invention will be
readily apparent to those skilled in the art from the following detailed
description of the preferred embodiments of the invention, the drawings,
and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic view of a system including a medical device embodying
the present invention;
FIG. 2 is an enlarged cross-sectional elevational view of the distal end
portion of the medical device of FIG. 1;
FIG. 3 is another enlarged elevational view, partly in section, of a
further alternative embodiment of the medical device shown received within
a blood vessel having a constriction;
FIG. 4 is an enlarged elevational view, partly in section, of the distal
end portion of a further alternative embodiment for the medical device;
FIG. 5 is further enlarged cross-sectional view taken generally along plane
5--5 of FIG. 4 showing the internal structure of the medical device of
FIG. 4;
FIG. 6 is an elevational view of a further alternative embodiment for the
medical device;
FIG. 7 is an enlarged cross-sectional view taken generally along plane 7--7
of FIG. 6 showing the internal structure of the medical device of FIG. 6;
and
FIG. 8 is a cross-sectional view of a still further embodiment for the
medical device.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
While this invention can be embodied in many different forms, there are
shown in the drawings and described in detail, preferred embodiments of
the invention. The present disclosure is an exemplification of the
principles of the invention and is not intended to limit the invention to
the embodiments illustrated.
The present invention is a medical device for delivering and applying
localized heat to a site in a patient's body. The heat can be used to stop
bleeding or remove or alter a material such as tissue or deposit in the
body. The material being altered can be any solid or semi-solid substance
found in the body including living tissue or deposits such as clots, fat
or arteriosclerotic plaque.
FIGS. 1 and 2 show a medical device 10 embodying the present invention and
including an elongated light transmitting conduit 12 such as an optical
fiber or a microwave channel or waveguide, having a proximal end 14 and a
distal end 16. A heat generating element 18 is mounted with respect to the
distal end 16 of the conduit 12 such that light transmitted by the fiber
is absorbed and converted by the element into heat. The light is emitted
by the distal end 16 of the conduit and is received and collected by a
light receiving surface 20 on the element 18. The element 18 is preferably
mounted on the distal end 16 of the conduit 12 and retained in that
position by appropriate means discussed in more detail below. Mounting the
element 18 directly on the conduit 12 insures that the light is properly
delivered and the element will not become disengaged from the conduit.
The conduit 12 is preferably a single, flexible light-transmitting fiber
such as used in fiberoptic devices and generally has a total exterior
diameter of about one millimeter or less. A single fiber generally has the
rigidity needed to press the element into a deposit or tissue. Larger or
smaller fibers can be used depending on the available area in a patient.
Generally, the single, light-transmitting fiber 13 includes a fiber core
22 surrounded by cladding 28. The internal reflection caused by the
cladding 28 should be such that the fiber 13 has a low divergence as the
light exits the distal end 16. The core 22 and the cladding 28 are made of
glass, e.g. silica quartz with a combined diameter of less than about 0.5
millimeter to about 1.0 millimeter. Substantially all of the light exiting
the distal end 16 should be directed forward to be absorbed by the light
receiving surface 20. This generates the majority of the heat at the
forward end of the heat generating element 18 where it is needed while
minimizing the heat on the rearward portions of the element where it could
otherwise be detrimental to the fiber 13.
To protect the fiber core 22 and cladding 28, the fiber also includes a
jacket 26 which surrounds the cladding 28 and is held in place by a resin
coating 24. The external jacket 26 is usually made of a flexible plastic
material such as poly(ethylene) or poly(tetrafluoroethylene). This also
provides a flexible and smooth surface allowing easy manipulation of the
medical device. Fiber optic bundles are not prefered since the glue
between individual fibers limits the amount of light which can be
transmitted without melting of the bundle.
The conduit 12 should be flexible yet sufficiently resilient so that it is
possible to push the conduit along a lumen to drive the heat generating
element 18 into and through an obstruction. One such suitable conduit is a
fiber optic having a core diameter of 0.4 millimeters which is marketed
under the trademark Med 400 by Quartz Products Corporation of Plainfield,
N.J.
The forward portion of the heat generating element 18 is preferably
generally rounded on its exterior surface to facilitate pressing the
element into and through softened body material. The heat generating
element can alternatively have other shapes as desired including oblong or
eccentric with respect to the axis of the fiber or even generally
crescent-shaped. Such an eccentric or oblong shape can be rotated to
generate an even larger channel through an obstruction. A crescent-shaped
element allows for fluid flow and viewing past the element.
The element 18 is preferably made of metal such as surgical stainless
steel, but could also be made of a combination of thermally conductive and
insulating material such as metal and ceramic. The inside light receiving
surface 20 is preferably treated, e.g., oxidized, to increase its
coefficient of emissivity to about 0.95 or greater to further increase the
absorption of light by the element 18. Alternatively, the surface 20 can
be treated by being coated by a material having a high coefficient of
emissivity such as lamp or carbon black. The exterior surface of the heat
generating element 18 is preferably coated with a non-stick or release
surface such as poly(tetrafluoroethylene) to provide easy release from the
tissue poly(tetrafluoroethylene) should only be used for operating
temperatures below about 300 degrees C.
The distal end 16 of the conduit 12 is preferably positioned or received in
cavity 30 defined by the rear portion of the heat generating element 18.
The element 18 can be retained on the distal end 16 by appropriate means
for mounting such as an adhesive, an appropriate locking means, or a
combination of both. The locking means is preferably at least one inwardly
extending, peripheral ridge 34 on the element 18 received in a
complimentary groove 36 defined by the conduit 12. The groove 36 should
extend into the jacket 26 but not into either the core 22 or the cladding
28. The adhesive such as hardened epoxy resin can be used to retain the
element 18 on the conduit 12 while the ridges 34 are crimped into the
groove. Since some adhesives may become ineffective under intense heat,
the locking means provides a backup to ensure the element remains in
place.
The heat generating element 18 has sufficient mass to avoid burn-through
during use. However, the mass is not so great as to materially slow its
heating rate. For this reason, it is advantageous to place the thickest
portion of material in the forward portion of the element 18 where the
light infringes. A minimum amount of space between the distal end 16 of
the fiber and the light receiving surface 20 of the element 18 reduces the
presence of other matter such as air or liquid which, if present in excess
may require venting due to expansion as a result of the heat generated.
Where such a space is provided, one or more vents are supplied to provide
communication between the space and the outside surface of the element to
the ambient surroundings.
The distal end 16 of the fiber is preferably spaced no more than 2
diameters of the core 22 away from the light receiving surface 20. Where
the core is about 0.5 millimeters, this spacing should be no more than
about 1 millimeter. This relatively close spacing insures that
substantially all of the light is received on the forward light receiving
surface 20 and is not dispersed on the inside side walls of the cavity 30.
The medical device can serve as part of a system which, as shown in FIG. 1,
includes a light source such as a laser associated with the proximal end
14 of the fiber 13. The light source is chosen to deliver sufficient light
energy to raise the temperature of the element 18 to soften material
causing an obstruction or to destroy tissue. The system further includes
temperature sensing means such as a pyrometer also associated with the
proximal end 14 of the fiber for measuring the temperature of the element
18. Both the light source and temperature sensing means can be associated
with the proximal end 14 of the fiber 13 by a beam splitting means 42. The
beam splitting means 42 can be a partial mirror or a system such as a
rotating or movable mirror. When the mirror is in a first position the
laser light is directed into the fiber 13. After the laser is deactivated,
the mirror is then placed in a second position to direct the resulting
radiation or glow of the element 18 emitted by the fiber proximal end 14
to the pyrometer.
The laser produces the light which is converted by the heat generating
element 18 into heat. The word light is used in its broad sense, meaning
electromagnetic radiation which propagates through space and includes not
only visible light, but also infrared, ultraviolet and microwave
radiation. The laser is preferably used intermittently with temperature
measurements made between uses. By monitoring the glow of the heated
element 18 it is also possible to provide an advance warning of
approaching burn-through where the element 18 has been provided with a
layer of different metallic or non-metallic material 46 embedded within
the forward portion of the element 18.
The light can enter the fiber continuously or intermittently, as desired,
to maintain the element 18 above a predetermined temperature such that it
is capable of softening a plaque deposit or cauterizing bleeding tissue.
Where the medical device is used in a blood vessel, rapid heating of the
element 18 is preferred since this allows the softening and removal of
obstructing material while minimizing the amount of heat transferred to
the tissues surrounding the blood vessel. A slower heating rate releases a
greater total amount of energy into the entire tissue area while a rapid
heating rate releases less total energy, but concentrates it in a small
area within the material to be softened and removed. The element can be
first heated i.e., light transmission begun, and then contacted with the
deposit. This minimizes heat dissipation into the surrounding tissue and
allows the element to reach a higher temperature before contact.
An alternative embodiment for the medical device 110 is shown in FIG. 3.
The medical device is shown received within a blood vessel 152 having a
deposit 154 which reduces the operative size of the blood vessel to a
relatively small constricted channel 156. The medical device 110 includes
a light transmitting conduit 112 and a heat generating element 118
substantially as described above. The element 118 includes an enlarged
head portion to create a channel of relatively larger diameter in the
deposit 154.
The medical device 110 also includes an elongated tube 158 having a
proximal portion (not shown) and a distal portion 162 and defining a
passageway 164 along its length. The elongated tube 158 allows for
positioning the light transmitting conduit 112 and heated element 118 in a
lumen such as blood vessel 152 by passing the tube through the skin and
muscle layers of the patient into the blood vessel. The conduit 112 is
slidingly received in the tube 158 so that it can be moved longitudinally
with respect to the tube and the element 118 extended beyond the distal
portion 162 of the tube. The element can be of such size that it may be
received within the passageway 164 during the placement of the device
within the blood vessel 152. The tube 158 is then first located in a
vessel and a conduit 112 with a relatively small heated element as shown
in FIG. 2 inserted into the tube 158.
Alternatively, the element 118 as shown in FIG. 3 can be relatively larger
in cross section than the passageway 164 to create a larger channel in an
obstruction. The heated element can even be larger than the outer diameter
of the tube 158 allowing the tube to be advanced progressively as the
element is repeatedly pressed forward to create a longer channel. When the
heated element is larger in cross section than the passageway 164, the
element can rest against the opening of the tube distal portion 162 during
insertion into the blood vessel.
The defined annular passageway 164 permits the introduction of fluid into
the blood vessel such as a radiopaque liquid which allows fluoroscopic
study of the size and location of the deposit 154 and the constricted
channel 156. The element 118, also radiopaque can also be fluoroscopically
tracked. The conduit 112 and tube 158 can also be provided with radiopaque
markings along their lengths for fluoroscopic tracking.
The tube 158 preferably carries a blood flow occlusion means such as an
inflatable balloon 166 positioned circumferentially about the tube on the
distal portion 162. The balloon 166 is preferably made of a suitable
flexible plastic material and is inflated to contact and seal with the
blood vessel wall by introducing a fluid such as carbon dioxide through a
channel 168 defined by a thickened wall of the tube 158. After the blood
vessel 152 has been occluded, a fluid such as a physiologically tolerable
flushing liquid can be introduced through passageway 164. Suitable liquids
include a saline solution, a dextrose solution, or an oxygen bearing
liquid which provides oxygen to tissue downstream of the balloon. A
radiopaque liquid can also be introduced for fluoroscopic viewing as
described above. A physiologically tolerable gas such as carbon dioxide
can also be introduced through the passageway 164 such that it surrounds
the element 118 with a temporary gas bubble to minimize dissipation of
heat from the element which otherwise would be directed into blood or
radiopaque liquid. This also avoids damage to the blood. The gas bubble or
introduced liquid can be withdrawn by suction through the passageway 164
after the procedure is over. Any debris generated can also be removed by
suction.
A still further alternative embodiment for the medical device 210 is shown
in FIGS. 4 and 5. As before, the heat generating element 218 is mounted on
the distal end 216 of the light transmitting conduit 212. The resin
coating 224 and jacket 226 have been trimmed back from the distal end 216
of the fiber 213 leaving a section of the clading 228 surrounding the
fiber core 222 open to the sides.
The removal of the resin coating 224 and jacket 226 from the end portion of
the fiber core 222 creates a spacing between the fiber core 222 and the
element 218. The air in this space serves as an insulator between the
element 218 and the fiber 213. Suitable other insulating materials can
also be located between the element and fiber. Directing substantially all
of the emitted light onto the light receiving surface 220 on the forward
portion of the element 218 together with this spacing minimizes the
conduction of heat from the element 218 to the jacket 226 of the conduit
212. To further limit the transfer of heat from the forward portion of the
element 218 toward the rearward portion, a section of reduced metal
thickness such as caused by a peripheral notch 272 can be provided.
Because there is less metal in the area of the notch 272, a lesser
cross-sectional area for heat conduction is available and there is less
transfer of heat per unit time toward the rearward portion of the elemen | | |