U.S. patent application number 11/791448 was filed with the patent office on 2010-09-09 for methods and apparatus for hemostasis following arterial catheterization.
This patent application is currently assigned to CARDIODEX LTD.. Invention is credited to Aharon Cohen, Shimon Eckhouse, Alon Getz, Fabian Izhack, Eran Levit, Noam Mizrahi.
Application Number | 20100228241 11/791448 |
Document ID | / |
Family ID | 32853102 |
Filed Date | 2010-09-09 |
United States Patent
Application |
20100228241 |
Kind Code |
A1 |
Eckhouse; Shimon ; et
al. |
September 9, 2010 |
METHODS AND APPARATUS FOR HEMOSTASIS FOLLOWING ARTERIAL
CATHETERIZATION
Abstract
A hemostasis device including a shaft having a forward end, at
least one anchor balloon mounted on the shaft at the forward end
and at least one electrical resistance heating element, mounted on
the main shaft forward of the at least one anchor element and being
operable to enhance hemostasis.
Inventors: |
Eckhouse; Shimon; (Haifa,
IL) ; Mizrahi; Noam; (Netanya, IL) ; Izhack;
Fabian; (Nofit, IL) ; Getz; Alon; (Haifa,
IL) ; Cohen; Aharon; (Tirat Hacarmel, IL) ;
Levit; Eran; (Tirat-Hacarmel, IL) |
Correspondence
Address: |
PATTON BOGGS LLP
8484 WESTPARK DRIVE, SUITE 900
MCLEAN
VA
22102
US
|
Assignee: |
CARDIODEX LTD.
Tirat Hacarmel
IL
|
Family ID: |
32853102 |
Appl. No.: |
11/791448 |
Filed: |
February 2, 2005 |
PCT Filed: |
February 2, 2005 |
PCT NO: |
PCT/IL05/00122 |
371 Date: |
July 23, 2009 |
Current U.S.
Class: |
606/29 |
Current CPC
Class: |
A61B 2017/00026
20130101; A61B 2018/00214 20130101; A61B 2018/00898 20130101; A61B
2018/0022 20130101; A61B 2018/00422 20130101; A61B 18/1492
20130101; A61B 18/08 20130101; A61B 18/082 20130101; A61B
2017/00654 20130101; A61B 2018/00875 20130101; A61B 17/0057
20130101; A61B 2018/00589 20130101; A61B 2017/00601 20130101 |
Class at
Publication: |
606/29 |
International
Class: |
A61B 18/08 20060101
A61B018/08 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 3, 2004 |
IL |
PCT/IL04/00100 |
Claims
1. A hemostasis device comprising: a shaft having a forward end; at
least one anchor balloon element on said shaft at said forward end;
and at least one electrical resistance heating element, mounted on
said shaft forward of said at least one anchor element and being
operable to enhance hemostasis.
2. A hemostasis device according to claim 1 and wherein said at
least one anchor element comprises an anchor balloon.
3. A hemostasis device according to either of claims 1 and 2 and
wherein said at least one electrical resistance heating element is
configured to be suitable for passage through a catheter introducer
for introduction thereof to a desired hemostasis location and to be
foldable over said forward end of said shaft and said at least one
anchor balloon during said passage.
4. A hemostasis device according to claim 3 and wherein said
electrical resistance heating element is configured to be foldable
over said forward end of said shaft in a manner that portions of
said electrical resistance heating element generally do not overlap
when so folded.
5. A hemostasis device according to any of the preceding claims and
wherein said electrical resistance heating element is configured to
define a plurality of leaves.
6. A hemostasis device according to claim 5 and wherein said
plurality of leaves are arranged generally in a four-leaf clover
configuration.
7. A hemostasis device according to any of the preceding claims and
wherein said electrical resistance heating element is resiliently
bendable to be foldable over said forward end of said shaft and to
extend radially outward from said shaft prior to and following
folding thereof.
8. A hemostasis device according to any of the preceding claims and
also comprising at least one peripheral balloon, disposed
rearwardly of said at least one anchor balloon along said shaft
9. A hemostasis device according to claim 8 and wherein said shaft
comprises at least a first lumen and a second lumen, said first
lumen being operative to supply fluid to said anchor balloon for
inflation thereof and said second lumen being operative to supply
fluid to said peripheral balloon for inflation thereof.
10. A hemostasis device according to any of the preceding claims
and wherein said electrical resistance heating element is formed of
foil.
11. A hemostasis device according to either of claims 8 and 9 and
also comprising a first and a second conductor operative to supply
electrical power to said electrical resistance heating element,
said first conductor extending through said first lumen and said
second conductor extending through said second lumen.
12. A method for accelerating hemostasis of an artery having a
puncture after arterial catheterization, the method comprising the
steps of: following arterial catheterization, introducing through a
catheter introducer a hemostasis device including a shaft having a
forward end, at least one anchor balloon mounted on said shaft at
said forward end and at least one electrical resistance heating
element, mounted on said shaft forward of said at least one anchor
element, such that a forward end of said hemostasis device lies
exterior of the artery adjacent a puncture in a wall of the artery;
accelerating hemostasis in the vicinity of said puncture by
operating said electrical resistance heating element, thereby
shortening the time required for hemostasis; and following
hemostasis, removing said hemostasis device from the patient.
13. A method according to claim 12 and wherein said at least one
anchor element comprises an anchor balloon.
14. A method according to either of claims 12 and 13 and wherein
said introducing said hemostasis device includes passing said
hemostasis device through said catheter introducer including
folding said at least one electrical resistance heating element
over said forward end of said shaft and said at least one anchor
balloon.
15. A method according to claim 14 and wherein said folding is such
that portions of said electrical resistance heating element
generally do not overlap when they are folded.
16. A method according to any of the preceding claims 12-15 and
wherein said electrical resistance heating element is configured to
define a plurality of leaves, and wherein said folding includes
folding of said leaves in a generally non-overlapping
arrangement.
17. A method according to any of the preceding claims 12-16 and
wherein during said folding said electrical resistance heating
element is resiliently bent and folded over said forward end of
said shaft and prior to and following said folding, said electrical
resistance heating element extends radially outward from said
shaft.
18. A method according to any of the preceding claims 12-17 and
wherein said hemostasis device also includes at least one
peripheral balloon, disposed rearwardly of said at least one anchor
balloon along said shaft and being arranged for operational
interaction with tunica intima, tunica media and tunica adventitia
portions of said artery and wherein said accelerating hemostasis
comprises: allowing a limited volume of blood to collect outside of
said artery in a region delimited by the engagement of said at
least one peripheral balloon with said artery, following deflation
of said anchor balloon; and employing inflation of said at least
one peripheral balloon to apply pressure to said artery to cause
said tunica intima, tunica media and tunica adventitia portions on
both sides of said puncture to be mutually engaged.
19. A method according to claim 18 and wherein said accelerating
hemostasis also comprises supplying electrical power to said
electrical resistance heating element which stimulates denaturation
of proteins in said tunica adventitia portion, thereby causing said
tunica adventitia portion to sealingly bridge said tunica media
portion at said puncture.
20. A method according to any of claims 12-19 and wherein said
accelerating hemostasis comprises supplying electrical power to
said electrical resistance heating element for less than 5 seconds.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is related to and claims priority of PCT
Application PCT/IL2004/000100, filed Feb. 3, 2004, the disclosure
of which is hereby incorporated by reference, entitled "METHODS AND
APPARATUS FOR HEMOSTASIS FOLLOWING ARTERIAL CATHETERIZATION" under
CFR section 1.78(a)(4) and CFR section 1.78(a)(5)(i).
FIELD OF THE INVENTION
[0002] The present invention relates to catheterization systems and
methodologies generally and more particularly to
post-catheterization closure.
BACKGROUND OF THE INVENTION
[0003] Various techniques are known for arterial catheterization.
Following arterial catheterization, it is necessary to promote
hemostasis quickly and without undue hardship for the patient.
[0004] Applicant's U.S. Pat. Nos. 5,728,134 and 6,048,358, and
Published PCT Patent Applications WO 98/11830 and WO 00/02488
describe methods and apparatus for hemostasis that greatly simplify
hemostasis and thus greatly reduce patient discomfort following
arterial catheterization. These patent documents, the disclosures
of which are hereby incorporated by reference, and the prior art
referenced therein are considered to represent the state of the
art.
SUMMARY OF THE INVENTION
[0005] The present invention seeks to provide improved systems and
methodologies for post-catheterization closure.
[0006] There is thus provided in accordance with a preferred
embodiment of the present invention a hemostasis device including a
shaft having a forward end, at least one anchor balloon mounted on
the shaft at the forward end and at least one electrical resistance
heating element, mounted on the main shaft forward of the at least
one anchor element and being operable to enhance hemostasis.
[0007] In accordance with a preferred embodiment of the present
invention the at least one anchor element comprises an anchor
balloon. Preferably, electrical resistance heating element is
configured to be suitable for passage through a catheter introducer
for introduction thereof to a desired hemostasis location and to be
foldable over the forward end of the shaft and the at least one
anchor balloon during the passage.
[0008] In accordance with another preferred embodiment of the
present invention, the electrical resistance heating element is
configured to be foldable over the forward end of the shaft in a
manner that portions of the electrical resistance heating element
generally do not overlap when so folded. Preferably, the electrical
resistance heating element is configured to define a plurality of
leaves. Optionally and preferably, the plurality of leaves are
arranged generally in a four-leaf clover configuration.
[0009] In accordance with yet another preferred embodiment of the
present invention the electrical resistance heating element is
resiliently bendable to be foldable over the forward end of the
shaft and to extend radially outward from the shaft prior to and
following folding thereof.
[0010] In accordance with a further preferred embodiment of the
present invention the hemostasis device also includes at least one
peripheral balloon, disposed rearwardly of the at least one anchor
balloon along the shaft.
[0011] In accordance with a still further preferred embodiment of
the present invention the shaft includes at least a first lumen and
a second lumen, the first lumen being operative to supply fluid to
the anchor balloon for inflation thereof and the second lumen being
operative to supply fluid to the peripheral balloon for inflation
thereof.
[0012] In accordance with yet a further preferred embodiment of the
present invention the electrical resistance heating element is
formed of foil.
[0013] In accordance with another preferred embodiment of the
present invention the hemostasis device also includes a first and a
second conductor operative to supply electrical power to the
electrical resistance heating element, the first conductor
extending through the first lumen and the second conductor
extending through the second lumen.
[0014] There is also provided in accordance with a preferred
embodiment of the present invention a method for accelerating
hemostasis of an artery having a puncture after arterial
catheterization, the method including the steps of following
arterial catheterization, introducing through a catheter introducer
a hemostasis device including a shaft having a forward end, at
least one anchor element mounted on the shaft at the forward end
and at least one electrical resistance heating element, mounted on
the shaft forward of the at least one anchor balloon, such that a
forward end of the hemostasis device lies exterior of the artery
adjacent a puncture in a wall of the artery, accelerating
hemostasis in the vicinity of the puncture by operating the
electrical resistance heating element, thereby shortening the time
required for hemostasis and following hemostasis, removing the
hemostasis device from the patient.
[0015] In accordance with a preferred embodiment of the present
invention the introducing the hemostasis device includes passing
the hemostasis device through the catheter introducer including
folding the at least one electrical resistance heating element over
the forward end of the shaft and the at least one anchor balloon.
Preferably, the folding is such that portions of the electrical
resistance heating element generally do not overlap when they are
folded.
[0016] In accordance with another preferred embodiment of the
present invention the electrical resistance heating element is
configured to define a plurality of leaves, and wherein the folding
includes folding of the leaves in a generally non-overlapping
arrangement. Preferably, during the folding the electrical
resistance heating element is resiliently bent and folded over the
forward end of the shaft and prior to and following the folding,
the electrical resistance heating element extends radially outward
from the shaft.
[0017] In accordance with a further preferred embodiment of the
present invention the hemostasis device also includes at least one
peripheral balloon, disposed rearwardly of the at least one anchor
balloon along the shaft and being arranged for operational
interaction with tunica intima, tunica media and tunica adventitia
portions of the artery and wherein the accelerating hemostasis
includes allowing a limited volume of blood to collect outside of
the artery in a region delimited by the engagement of the at least
one peripheral balloon with the artery, following deflation of the
anchor balloon and employing inflation of the at least one
peripheral balloon to apply pressure to the artery to cause the
tunica intima, tunica media and tunica adventitia portions on both
sides of the puncture to be mutually engaged.
[0018] In accordance with a still further preferred embodiment of
the present invention the accelerating hemostasis also includes
supplying electrical power to the electrical resistance heating
element which stimulates denaturation of proteins in the tunica
adventitia portion, thereby causing the tunica adventitia portion
to sealingly bridge the tunica media portion at the puncture.
Preferably, the accelerating hemostasis includes supplying
electrical power to the electrical resistance heating element for
less than 5 seconds.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] The present invention will be understood and appreciated
more fully from the following detailed description, taken in
conjunction with the drawings in which:
[0020] FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1G, 1H, 1I, 1J and 1K are
simplified illustrations of a hemostasis device constructed and
operative in accordance with another preferred embodiment of the
present invention and various stages of its operation in a patient
treatment context.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0021] Reference is now made to FIGS. 1A, 1B, 1C, 1D, 1E, 1F, 1G,
1H, 1I, 1J and 1K, which are simplified illustrations of a
hemostasis device constructed and operative in accordance with
still another preferred embodiment of the present invention and
various stages of its operation in a patient treatment context.
[0022] FIG. 1A shows a hemostasis device 100 for producing
hemostasis following arterial catheterization, in accordance with a
preferred embodiment of the present invention. The hemostasis
device 100 is suitable for insertion via a conventional catheter
introducer (not shown) following completion of catheterization and
removal of the catheter from the catheter introducer.
[0023] In accordance with a preferred embodiment of the present
invention, hemostasis device 100 comprises a main shaft 102, which
has first and second lumens 104 and 106. First lumen 104 extends
along the main shaft 102 to an anchor balloon inflation location
112. Second lumen 106 extends along the shaft 102 to a peripheral
balloon inflation location 122.
[0024] Disposed at an end of main shaft 102 at anchor balloon
inflation location 112 is an anchor element such as an anchor
balloon 140. Anchor balloon 140 is selectably inflated via a
stopcock 142 and associated conduit 144 in fluid communication with
first lumen 104 in main shaft 102 formed in head element 150. Head
element 150 is fixed to main shaft 102 at an end thereof opposite
the end at which anchor balloon 140 is located.
[0025] Disposed adjacent the end of main shaft 102 in fluid
communication with peripheral balloon inflation location 122,
exterior of an outer wall 152 thereof, is a peripheral balloon 160.
Peripheral balloon 160 is selectably inflated via second lumen 106,
via a stopcock 162 and associated conduit 164 formed in head
element 150.
[0026] Additionally, in accordance with a preferred embodiment of
the present invention, an electrical resistance heating element 180
is disposed forwardly of the anchor balloon 140. Preferably, the
resistance heating element 180 is formed of a foil which is
electrically coupled at opposite ends thereof to electrical
conductors which extend through the main shaft 102. In the
illustrated embodiment, a first conductor 182 is attached to a
first end 184 of resistance heating element 180 and preferably
extends through the first lumen 104, and a second conductor 186 is
attached to a second end 188 of resistance heating element 180 and
extends through the second lumen 106.
[0027] Preferably, the resistance heating element 180 has a
generally four-leaf clover configuration, as shown, including
radially extending leaves 190, which are preferably retained in
position at the end of main shaft 102 by a retaining disc 192.
Alternatively retaining disc 192 may be obviated. Electrical power
is supplied to resistance heating element 180 via a switch 196,
which couples first conductor 182 and second conductor 186 to a
source of electrical power. Heating of resistance heating element
180 enhances hemostasis at the aperture in the artery.
[0028] Reference is now made to FIGS. 1B-1J, which illustrate
various steps in a preferred mode of operation of the apparatus of
FIG. 1A.
[0029] FIG. 1B illustrates the hemostasis device 100 about to be
inserted into an artery 200 via a conventional catheter introducer
assembly 202, following completion of a catheterization procedure
and withdrawal of a catheter (not shown) from the catheter
introducer assembly 202. The catheter introducer assembly 202
conventionally includes a catheter introducer sheath 204 and an
entry funnel portion 205. FIG. 1B also shows in cross-section, the
catheter introducer sheath 204 extending through a puncture 206 in
the artery 200. It is seen that the tunica intima 208 and the
tunica media 210 as well as the tunica adventitia 212 are spread
apart at the puncture 206 by the presence therein of the catheter
introducer sheath 204.
[0030] FIG. 1C shows the hemostasis device 100 inserted into the
catheter introducer assembly 202 such that the leaves 190 are each
individually folded backwards over the end of the main shaft 102
and over balloons 140 and 160 and do not generally overlap each
other.
[0031] FIG. 1D shows the hemostasis device 100 inserted through the
catheter introducer assembly 202 such that the outer end of the
main shaft 102 extends into the artery 200 well beyond the end of
catheter introducer sheath 204. As shown with particularity in FIG.
1D, at this stage both anchor balloon 140 and peripheral balloon
160 are deflated. It is seen that the leaves 190 of the resistance
heating element 180 have returned to their generally planar
orientation, extending radially outward from main shaft 102.
[0032] Reference is now made to FIG. 1E, which shows initial
inflation of the anchor balloon 140, preferably by use of a syringe
220, communicating with first lumen 104 via the interior of head
element 150, stopcock 142 and associated conduit 144. The inflated
anchor balloon 140 preferably has a cusp-type configuration.
[0033] Following inflation of the anchor balloon 140, the catheter
introducer assembly 202 and the hemostasis device 100 are both
withdrawn, such that the catheter introducer sheath 204 is removed
from artery 200 only when the anchor balloon 140 already engages
the interior wall of artery 200 in sealing engagement with the
aperture in the artery 200 through which the catheter introducer
sheath 204 is withdrawn and through which the main shaft 102
presently extends. This stage is shown in FIG. 1F.
[0034] As seen in FIG. 1G, initial inflation of the peripheral
balloon 160 is effected, preferably by use of a syringe 240
communicating with second lumen 106 via head element 150, stopcock
162 and associated conduit 164.
[0035] Thereafter, as seen in FIG. 1H, the anchor balloon 140 is
deflated, preferably by operation of syringe 220, communicating
with first lumen 104 via head element 150, stopcock 142 and
associated conduit 144, and the peripheral balloon 160 remains
fully inflated, which preferably causes the extreme end of the main
shaft 102 to be withdrawn from the artery 200 to a location lying
just outside the artery wall. As seen in FIG. 1H, peripheral
balloon 160 is preferably designed to allow a limited volume of
blood to collect outside of the artery wall after the anchor
balloon 140 is deflated. This volume of blood is located, in a
region, indicated by reference numeral 250, delimited by the
engagement of peripheral balloon 160 with the artery wall.
[0036] It is noted that at this stage, the tunica intima 208 and
the tunica media 210 as well as the tunica adventitia 212 are no
longer spread apart at the puncture 206, inasmuch as the main shaft
102 is no longer present thereat and in response to pressure
applied to the artery 200 by inflated peripheral balloon 160.
[0037] Preferably at this stage heating of the electrical
resistance heating element 180 is effected, preferably by an
operator closing switch 196, as shown in FIG. 1I. This heating
preferably continues for less than five seconds.
[0038] Once acceptable hemostasis has occurred in region 250, the
peripheral balloon 160 is deflated, as shown in FIG. 1J, preferably
by operation of syringe 240, communicating with second lumen 106
via head element 150, stopcock 162 and associated conduit 164.
[0039] Thereafter, the hemo stasis device 100 is entirely withdrawn
from the patient, leaving a region 250 of hemostasis outside of
artery 200, as shown in FIG. 1K.
[0040] It is noted that at this stage, by virtue of denaturation of
the proteins thereof, the tunica adventitia 212 sealingly bridges
the tunica media at the region of the puncture 206. Preferably, the
operation of the electrical resistance heating element 180 does not
produce significant heating of the tunica media and tunica intima,
and does not produce heat-induced welding thereat, thus preventing
the formation of lesions thereat that could otherwise occur due to
excessive heating thereof.
[0041] It will be appreciated by persons skilled in the art that
the present invention is not limited by 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 and shown in the drawings as
well as modifications and further developments thereof which would
occur to a person of ordinary skill in the art upon reading the
foregoing description and which are not in the prior art.
* * * * *