U.S. patent application number 15/596731 was filed with the patent office on 2017-08-31 for catheter with perforated tip.
The applicant listed for this patent is BIOSENSE WEBSTER, INC.. Invention is credited to Andres Claudio Altmann, Assaf Govari, Athanassios Papaioannou.
Application Number | 20170245927 15/596731 |
Document ID | / |
Family ID | 41061151 |
Filed Date | 2017-08-31 |
United States Patent
Application |
20170245927 |
Kind Code |
A1 |
Govari; Assaf ; et
al. |
August 31, 2017 |
CATHETER WITH PERFORATED TIP
Abstract
A medical device includes an insertion tube, having a distal end
for insertion into a body of a subject. A distal tip is fixed to
the distal end of the insertion tube and is coupled to apply energy
to tissue inside the body. The distal tip has an outer surface with
a plurality of perforations through the outer surface, which are
distributed circumferentially and longitudinally over the distal
tip. A lumen passes through the insertion tube and is coupled to
deliver a fluid to the tissue via the perforations.
Inventors: |
Govari; Assaf; (Haifa,
IL) ; Papaioannou; Athanassios; (Los Angeles, CA)
; Altmann; Andres Claudio; (Haifa, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
BIOSENSE WEBSTER, INC. |
Irvine |
CA |
US |
|
|
Family ID: |
41061151 |
Appl. No.: |
15/596731 |
Filed: |
May 16, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
12173150 |
Jul 15, 2008 |
9675411 |
|
|
15596731 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2018/1869 20130101;
A61N 7/022 20130101; A61B 18/18 20130101; A61B 2018/1425 20130101;
A61B 18/1815 20130101; A61B 2018/1861 20130101; A61B 2018/00577
20130101; A61B 18/1477 20130101; A61B 18/1492 20130101; Y10T
29/49826 20150115; A61B 2218/002 20130101 |
International
Class: |
A61B 18/14 20060101
A61B018/14; A61N 7/02 20060101 A61N007/02; A61B 18/18 20060101
A61B018/18 |
Claims
1. A medical device, comprising: an insertion tube, having a distal
end for insertion into a body of a subject at a treatment area; a
conductive hollow distal tip having a length and a thickness
between an inner surface and an outer surface, the conductive
hollow distal tip being fixed to the distal end of the insertion
tube and coupled to a generator, the conductive hollow distal tip
and the generator being configured to directly apply energy to
tissue at the treatment area inside the body, and wherein the
conductive hollow distal tip has a distribution of perforations
that extend from the inner surface to the outer surface, and
wherein at least a portion of the perforations are
circumferentially and longitudinally arranged over the outer
surface of the hollow distal tip and sized and configured to ensure
equal flow of a cooling fluid over the entire length of the
conductive hollow distal tip while not overloading the treatment
area with the cooling fluid; and a lumen passing through the
insertion tube and coupled to deliver the cooling fluid to the
tissue at the treatment area via the perforations.
2. The device according to claim 1, wherein the plurality of the
perforations comprises at least eight perforations.
3. The device according to claim 1, wherein the plurality of the
perforations comprises at least fifty perforations.
4. The device according to claim 1, wherein the perforations have a
diameter less than 0.5 mm.
5. The device according to claim 1, wherein the distribution of the
at least 50 perforations is a distribution of at least 96
perforations, each having a diameter less than or equal to
approximately 0.1 mm.
6. The device according to claim 1, wherein the perforations in the
distribution of perforations near the proximal end of the
conductive hollow distal tip are smaller than the perforations in
the distribution of perforations near the distal end of the
conductive hollow distal tip to ensure equal flow of the cooling
fluid over the length of the conductive hollow distal tip.
7. The device according to claim 1, wherein the outer surface of
the conductive hollow distal tip is configured to contact and apply
electrical energy to the tissue so as to ablate the tissue.
8. A medical apparatus, comprising: an elongate probe, for
insertion into a body of a subject, the elongate probe comprising:
an insertion tube, having a distal end for insertion into the body;
a conductive hollow distal tip having a length and an inner and
outer surface, which is fixed to the distal end of the insertion
tube and is coupled to an energy generator to directly apply energy
to tissue inside the body at a treatment area, and which has a
distribution of a plurality of perforations distributed through the
conductive hollow distal tip, and wherein at least a portion of
perforations are circumferentially and longitudinally arranged over
the outer surface of the conductive hollow distal tip and sized and
configured to ensure equal flow of a cooling fluid over the entire
length; a lumen passing through the insertion tube and in fluid
communication with the distribution of the perforations; and an
irrigation pump, for coupling to the lumen so as to supply the
cooling fluid via the lumen and the distribution of the
perforations to the tissue.
9. The apparatus according to claim 8, wherein the cylindrically
shaped outer surface of the conductive hollow distal tip comprises
a conductive material and is configured to contact the tissue, and
wherein the energy generator is coupled to supply electrical energy
to the conductive hollow distal tip in order to ablate the
tissue.
10. The apparatus according to claim 9, wherein the elongate probe
is configured for insertion through a blood vessel into a heart of
the subject for ablation of myocardial tissue in the heart.
11. The apparatus according to claim 8 wherein each perforation of
the distribution of the perforations is not greater than 0.2 mm in
diameter.
12. The apparatus according to claim 8 wherein the perforations in
the distribution of perforations near the proximal end of the
conductive hollow distal tip are smaller than the perforations in
the distribution of the perforations near the distal end of the
conductive hollow distal tip.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a Continuation of U.S. patent
application Ser. No. 12/173,150, filed Jul. 15, 2008, now U.S.
Patent Publication No. 2010/0030209, published Feb. 4, 2010, the
entire content of which is incorporated herein by reference.
FIELD OF THE INVENTION
[0002] The present invention relates generally to medical devices,
and specifically to cooling of tissue contacted by an invasive
probe within the body.
BACKGROUND OF THE INVENTION
[0003] In some medical procedures, energy is imparted to body
tissue locally, in a concentrated dose, and it is desirable to cool
the treatment area in order to reduce collateral tissue damage.
[0004] For example, cardiac ablation therapy is used to treat
arrhythmias by heating tissue with radio-frequency (RF) electrical
energy to create non-conducting lesions in the myocardium. It has
been found that cooling the area of the ablation site reduces
tissue charring and thrombus formation. For this purpose, Biosense
Webster Inc. (Diamond Bar, Calif.) offers the ThermoCool.RTM.
irrigated-tip catheter as part of its integrated ablation system.
The metal catheter tip, which is energized with RF current to
ablate the tissue, has a number of peripheral holes, distributed
circumferentially around the tip, for irrigation of the treatment
site. A pump coupled to the catheter delivers saline solution to
the catheter tip, and the solution flows out through the holes
during the procedure in order to cool the catheter tip and the
tissue.
SUMMARY OF THE INVENTION
[0005] Despite the general usefulness of irrigation in reducing
collateral tissue damage, the inventors have found that in some
cases, the tissue and treatment device in the vicinity of the
treatment area are not adequately or uniformly cooled. Problems may
arise, for example, due to blockage of the irrigation holes in the
treatment catheter.
[0006] Embodiments of the present invention that are described
hereinbelow provide multiple perforations in the distal tip of a
treatment device, such as a catheter or other probe. The
perforations are distributed both circumferentially and
longitudinally over the distal tip. The large number of
perforations and their longitudinal distribution help to ensure
adequate irrigation of the entire distal tip and treatment area and
thus reduce collateral tissue damage, as well as preventing
adhesion of the distal tip to the tissue.
[0007] There is therefore provided, in accordance with an
embodiment of the present invention a medical device, comprising an
insertion tube, having a distal end for insertion into a body of a
subject at a treatment area. A conductive hollow distal tip having
a length and a thickness between an inner surface and an outer
surface is fixed to the distal end of the insertion tube and
coupled to a generator. The conductive hollow distal tip and the
generator are configured to directly apply energy to tissue at the
treatment area inside the body. The conductive hollow distal tip
further includes a distribution of perforations that extend from
the inner surface to the outer surface, wherein at least a portion
of the perforations are circumferentially and longitudinally
arranged over the outer surface of the hollow distal tip and sized
and configured to ensure equal flow of a cooling fluid over the
entire length of the conductive hollow distal tip while not
overloading the treatment area with the cooling fluid. The medical
device further comprises a lumen passing through the insertion tube
and coupled to deliver the cooling fluid to the tissue at the
treatment area via the perforations.
[0008] There is additionally provided a medical apparatus,
comprising an elongate probe for insertion into a body of a
subject. The elongate probe includes an insertion tub, having a
distal end for insertion into the body. A conductive hollow distal
tip having a length is fixed to the distal end of the insertion
tube and is coupled to an energy generator to directly apply energy
to tissue inside the body at a treatment area. A distribution of a
plurality of perforations are distributed through the conductive
hollow distal tip, wherein at least a portion of perforations are
circumferentially and longitudinally arranged over the outer
surface of the conductive hollow distal tip and sized and
configured to ensure equal flow of a cooling fluid over the entire
length. The medical apparatus further includes a lumen passing
through the insertion tube and in fluid communication with the
distribution of the perforations, and an irrigation pump, for
coupling to the lumen so as to supply the cooling fluid via the
lumen and the distribution of the perforations to the tissue.
[0009] The present invention will be more fully understood from the
following detailed description of the embodiments thereof, taken
together with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] FIG. 1 is a schematic, pictorial illustration of a system
for cardiac ablation therapy, in accordance with an embodiment of
the present invention;
[0011] FIG. 2 is a schematic sectional view of the distal end of a
catheter in engagement with heart tissue, in accordance with an
embodiment of the present invention;
[0012] FIG. 3 is a schematic side view of the distal tip of a
catheter, in accordance with an embodiment of the present
invention; and
[0013] FIG. 4 is a schematic side view of apparatus used in
producing a perforated catheter tip, in accordance with an
embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS
[0014] FIG. 1 is a schematic, pictorial illustration of a system 20
for cardiac ablation therapy, in accordance with an embodiment of
the present invention. An operator 26 inserts a catheter 28 through
a blood vessel into a chamber of a heart 24 of a subject 22, and
manipulates the catheter so that a distal end 32 of the catheter
contacts the endocardium in an area that is to be treated. The
distal tip of the catheter is perforated to enable optimal
irrigation of the treatment area, as shown and described
hereinbelow. In other respects, however, system 20 resembles
systems for cardiac ablation treatment that are known in the art,
such as the above-mentioned Biosense Webster system, and the
components of such systems may be adapted for use in system 20.
[0015] After positioning distal end 32 at an ablation site, and
ensuring that the tip is in contact with the endocardium at the
site, operator 26 actuates a radio frequency (RF) energy generator
44 in a control console 42 to supply RF energy via a cable 38 to
distal end 32. Meanwhile, an irrigation pump 48 supplies a cooling
fluid, such as saline solution, via a tube 40 and a lumen in
catheter 28 to the distal end. Operation of the RF energy generator
and the irrigation pump may be coordinated in order to give the
appropriate volume of irrigation during ablation, so as to cool the
tip of the catheter and the tissue without overloading the heart
with irrigation fluid. A temperature sensor (not shown in the
figures) in distal end 32 may provide feedback to console 42 for
use in controlling the RF energy dosage and/or irrigation
volume.
[0016] FIG. 2 is a schematic sectional view of distal end 32 of
catheter 28 in engagement with endocardial tissue in heart 24, in
accordance with an embodiment of the present invention. The
catheter terminates in a distal tip 50, which is fixed to the
distal end of an insertion tube 60 of the catheter. The distal tip
typically comprises a conductive material, such as platinum, while
the insertion tube has an insulating flexible outer sheath. The
outer surface of the distal tip is penetrated by multiple
perforations 52, which are distributed over the surface of the
distal tip both longitudinally (i.e., along the direction parallel
to the longitudinal axis of catheter 28) and circumferentially
(along circumferences around the axis).
[0017] FIG. 3 is a schematic side view of distal tip 50, showing
details of perforations 52, in accordance with an embodiment of the
present invention. The distal tip is hollow, with an outer surface
66 that encloses an interior space 64. Perforations 52 extend from
the outer surface into the interior space. For cardiac ablation
applications, the distal tip shown in FIG. 3 is typically about 2.5
mm in diameter and 6 mm long, with a wall thickness in the distal
part of the tip of about 0.25 mm. These dimensions, however, are
given solely by way of illustration, and larger or smaller
dimensions may be used depending on application requirements. The
edges of the distal tip, at both the distal and proximal
extremities of the tip, are typically rounded in order to avoid
possible concentration of the RF electric field around the
edges.
[0018] Typically, distal tip 50 has at least eight perforations,
which are less than 0.5 mm in diameter, in order to distribute the
irrigation over the tip both longitudinally and circumferentially
without overloading the heart with the cooling fluid. The inventors
have found it advantageous, however, to have at least fifty
perforations in the distal tip, with diameters no greater that 0.2
mm. In the actual embodiment that is shown in FIG. 3, tip 50 has
ninety-six perforations, with diameters of approximately 0.1 mm.
The sizes of the perforations may optionally be varied over the
length of the distal tip to compensate for pressure variation and
ensure equal flow over the entire length. For this purpose, the
perforations at and near the most distal part of the tip may be
made larger than the more proximal perforations, which are nearer
to the fluid inlet.
[0019] Returning now to FIG. 2, the proximal end of distal tip 50
is closed off by a plug 54, which has a fluid inlet 56 feeding
interior space 64. A lumen 58 passing through insertion tube 60 of
catheter 28 conveys fluid from irrigation pump 48 (FIG. 1) to inlet
56, filling interior space 64. The fluid exits tip 50 through
perforations 52 to the surrounding tissue. A conductor conveys RF
energy from RF generator 44 to the conductive tip, which thus
serves as an electrode for delivering the energy in order to ablate
the tissue.
[0020] FIG. 4 is a schematic side view of apparatus used in
creating perforations 52 in distal tip 50, in accordance with an
embodiment of the present invention. In this embodiment, the
perforations in the tip are produced by electrical spark discharge.
Tip 50 is mounted in a suitable rotating jig 70 (such as a lathe
chuck). A needle electrode 72, such as a carbon needle, is held at
a potential of several thousand volts by a high-voltage power
supply 76. A motion assembly 74 gradually brings the needle
electrode into proximity with the point on the catheter tip at
which a perforation is to be made. The procedure is typically
carried out in a controlled gas environment (such as an argon
atmosphere). At a distance of about 1 mm, a spark jumps from the
electrode to the catheter tip. The discharge creates a small
perforation, typically about 100 .mu.m in diameter, in the tip. The
size of the hole may be controlled by varying the discharge
voltage.
[0021] Jig then rotates tip 50 so that the location of the next
perforation is positioned opposite needle electrode 72, and the
next perforation is created in similar fashion. The electrode is
shifted longitudinally along the catheter tip to make multiple sets
of holes, which are distributed longitudinally and
circumferentially over the catheter tip as described above.
[0022] This method of creating holes in distal tip 50 permits a
large number of holes to be made precisely and inexpensively,
without structurally weakening the catheter tip. It allows the
sizes of the irrigation holes to be controlled in production to
give precisely the desired volume of irrigation, without clogging
of the holes on the one hand or overloading of the heart with
irrigation fluid on the other.
[0023] Although the embodiments described above relate specifically
to catheters used in RF ablation treatment within the heart, the
principles of the present invention may similarly be applied to
other organs and in other types of therapy that involve application
of energy to body tissues. For example, a device with a similar
sort of irrigated tip may be used in therapies that involve
microwave-based or ultrasonic tissue heating.
[0024] It will thus be appreciated that the embodiments described
above are cited by way of example, and that the present invention
is not limited to what has been particularly shown and described
hereinabove. Rather, the scope of the present invention includes
both combinations and subcombinations of the various features
described hereinabove, as well as variations and modifications
thereof which would occur to persons skilled in the art upon
reading the foregoing description and which are not disclosed in
the prior art.
* * * * *