U.S. patent application number 10/543654 was filed with the patent office on 2007-03-08 for methods and apparatus for hemostasis following arterial catheterization.
This patent application is currently assigned to CardioDex, LTD.. Invention is credited to Shimon Eckhouse, Izhack Fabian, Eran Levi, Hayim Lindenbaum, Noam Mizrahi.
Application Number | 20070055223 10/543654 |
Document ID | / |
Family ID | 32853102 |
Filed Date | 2007-03-08 |
United States Patent
Application |
20070055223 |
Kind Code |
A1 |
Eckhouse; Shimon ; et
al. |
March 8, 2007 |
Methods and apparatus for hemostasis following arterial
catheterization
Abstract
A hemostasis device including a resistance heating element for
accelerating hemostasis, a blood resistance sensor and a blood
resistance indicator, operative to provide an indication of the
resistance at the resistance sensor of blood undergoing
hemostasis.
Inventors: |
Eckhouse; Shimon; (Haifa,
IL) ; Lindenbaum; Hayim; (Haifa, IL) ;
Mizrahi; Noam; (Mountain-View, CA) ; Fabian;
Izhack; (Nofit, IL) ; Levi; Eran; (Kfar
Vradim, IL) |
Correspondence
Address: |
PATTON BOGGS LLP
8484 WESTPARK DRIVE
SUITE 900
MCLEAN
VA
22102
US
|
Assignee: |
CardioDex, LTD.
Tirat-Hacarmel
IL
39032
|
Family ID: |
32853102 |
Appl. No.: |
10/543654 |
Filed: |
February 3, 2004 |
PCT Filed: |
February 3, 2004 |
PCT NO: |
PCT/IL04/00100 |
371 Date: |
October 6, 2006 |
Current U.S.
Class: |
606/28 ;
128/898 |
Current CPC
Class: |
A61B 2017/00601
20130101; A61B 2017/00654 20130101; A61B 2018/00214 20130101; A61B
2018/00589 20130101; A61B 2018/00898 20130101; A61B 17/0057
20130101; A61B 2018/0022 20130101; A61B 2017/00026 20130101; A61B
18/1492 20130101; A61B 2018/00422 20130101; A61B 18/08 20130101;
A61B 18/082 20130101; A61B 2018/00875 20130101 |
Class at
Publication: |
606/028 ;
128/898 |
International
Class: |
A61B 18/04 20060101
A61B018/04; A61B 19/00 20060101 A61B019/00 |
Foreign Application Data
Date |
Code |
Application Number |
Feb 4, 2003 |
US |
10358130 |
Jul 10, 2003 |
US |
10616887 |
Claims
1. A hemostasis device comprising: a resistance heating element for
accelerating hemostasis; a blood resistance sensor; and a blood
resistance indicator, operative to provide an indication of the
resistance at said resistance sensor of blood undergoing
hemostasis.
2. A hemostasis device according to claim 1 and also comprising a
power supply connected to said resistance heating element, said
resistance sensor and said resistance indicator.
3. A hemostasis device according to claim 2 and wherein said power
supply is operative to supply a relatively high level current to
said resistance heating element.
4. A hemostasis device according to either of claims 2 and 3 and
wherein said power supply is operative to supply a relatively low
level current to said resistance sensor.
5. A method for accelerating hemostasis of an artery of a patient
having a puncture after arterial catheterization, the method
comprising the steps of: following arterial catheterization,
introducing a hemostasis device, such that a forward end of said
hemostasis device lies exterior of the artery adjacent said
puncture; accelerating hemostasis by heating tissue in the vicinity
of said puncture, thereby shortening the time required for
hemostasis; and following hemostasis, removing said hemostasis
device from the patient.
6. A method according to claim 5 and also comprising inserting a
catheter introducer into said artery prior to said arterial
catheterization and wherein following said arterial
catheterization, said hemostasis device is introduced through said
catheter introducer.
7. A method according to any of claims 5-6 and also comprising
measuring the conductivity of blood in the vicinity of said
puncture during hemostasis.
8. A method for monitoring the progress of hemostasis of an artery
of a patient having a puncture after arterial catheterization, the
method comprising the steps of: following arterial catheterization,
introducing a hemostasis device, such that a forward end of said
hemostasis device lies exterior of the artery adjacent said
puncture; during hemostasis, measuring the heat conductivity of
blood in the vicinity of said puncture, thereby to provide an
output indication of the progress of hemostasis; and following
hemostasis, removing said hemostasis device from the patient.
9. A method according to claim 8 and also comprising the step of
inserting into an artery a catheter introducer prior to arterial
catheterization and wherein following said arterial
catheterization, said hemostasis device is introduced through said
catheter introducer.
10. A method according to either of claim 8 or claim 9 and also
comprising inflating a balloon to block said puncture, prior to
said hemostasis.
11. A method according to claim 10 and also comprising deflating
said balloon prior to removing said hemostasis device.
12. A hemostasis device comprising: a main shaft; at least one
balloon mounted on said main shaft; and at least one electrode,
mounted on said main shaft and being operable to supply an electric
current suitable for causing hemostasis.
13. A hemostasis device according to claim 12 and wherein said at
least one balloon comprises: at least one anchor balloon, disposed
at an end of said main shaft; and at least one peripheral balloon,
disposed at a location along said main shaft exterior to a wall of
said main shaft.
14. A hemostasis device according to claim 13 and wherein said at
least one peripheral balloon and a wall of an artery are configured
to delimit a region which is subject to hemostasis.
15. A hemostasis device according to any of claims 12-14 and also
comprising an electrical power source and a control module.
16. A hemostasis device according to claim 15 and wherein said
power source is an RF power supply.
17. A hemostasis device according to claim 16 and wherein said RF
power supply is operative to supply electrical power at RF
frequencies within a range of 0.1-10 watts at up to 25 volts.
18. A hemostasis device according to any of claims 15-17 and
wherein said control module is operative to measure at least one of
electrical current, blood resistance and blood temperature.
19. A hemostasis device according to any of claims 15-18 and
wherein said control module is operative to adjust power supplied
by said power source based on at least one measurement.
20. A hemostasis device according to any of claims 12-19 and
wherein said at least one electrode comprises a pair of
electrodes.
21. A method for producing hemostasis at an artery of a patient
having a puncture following arterial catheterization comprising:
introducing a hemostasis device comprising at least one electrode
into the vicinity of said puncture; supplying an electric current
to said at least one electrode, thereby heating a volume of blood
in the vicinity of said puncture, causing hemostasis; and
subsequently removing said hemostasis device from the patient.
22. A method according to claim 21 and wherein said introducing
comprises introducing via a catheter introducer.
23. A method according to either of claims 21 and 22 and wherein
said introducing also comprises inflating an anchor balloon
attached to an end of said hemostasis device.
24. A method according to any of claims 21-23 and wherein said
introducing comprises inflating a peripheral balloon.
25. A method according to claim 24 and wherein said removing said
hemostasis device comprises deflating said peripheral balloon.
26. A method according to any of claims 21-25 and wherein said
introducing comprises positioning said at least one electrode in
close proximity to a volume of blood.
27. A method according to any of claims 21-26 and wherein said
supplying comprises supplying electrical power at RF
frequencies.
28. A method according to claim 27 and wherein said electrical
power comprises electrical power in the range of 0.1-10 watts at up
to 25 volts.
29. A method according to any of claims 21-28 and wherein said
supplying also comprises adjusting said electric current based on a
feedback measurement.
30. A hemostasis device comprising: a main shaft; at least one
balloon mounted on said main shaft adjacent an end thereof; and a
hemostasis agent supply conduit operative to supply a hemostasis
agent at a location at an end of said main shaft beyond said at
least one balloon.
31. A hemostasis device according to claim 30 and also comprising
at least one heating assembly operative to provide heating at said
location.
32. A hemostasis device according to claim 31 and wherein said at
least one heating assembly comprises at least one electrode
disposed adjacent said location.
33. A hemostasis device according to claim 32 and wherein said at
least one electrode is disposed interiorly of said at least one
balloon.
34. A hemostasis device according to claim 32 and wherein said at
least one electrode is disposed exteriorly of said at least one
balloon.
35. A hemostasis device according to any of claims 31-33 and
wherein said at least one heating assembly comprises an electrical
resistive heating element.
36. A hemostasis device according to claim 35 and wherein said
electrical resistive heating element is disposed within said at
least one balloon.
37. A hemostasis device comprising: a main shaft; at least one
balloon mounted on said main shaft adjacent an end thereof; and at
least one RF electrode located at a location at an end of said main
shaft beyond said at least one balloon.
38. A hemostasis device according to claim 37 and also comprising a
hemostasis agent supply conduit operative to supply a hemostasis
agent at a location at an end of said main shaft beyond said at
least one balloon.
39. A hemostasis device according to claim 37 and wherein said at
least one RF electrode is disposed interiorly of said at least one
balloon.
40. A hemostasis device according to claim 37 and wherein said at
least one RF electrode is disposed exteriorly of said at least one
balloon.
41. A hemostasis device comprising: a main shaft; at least one
balloon mounted on said main shaft adjacent an end thereof; and at
least one resistive heating element located at a location at an end
of said main shaft beyond said at least one balloon.
42. A hemostasis device according to claim 41 and also comprising a
hemostasis agent supply conduit operative to supply a hemostasis
agent at a location at an end of said main shaft beyond said at
least one balloon.
43. A hemostasis device according to claim 42 and wherein said at
least one resistance heating element is disposed interiorly of said
at least one balloon.
44. A method for producing hemostasis at an artery of a patient
having a puncture following arterial catheterization comprising:
introducing a hemostasis device including at least one balloon
mounted adjacent an end of a shaft to a location in the vicinity of
said puncture; and supplying a hemostasis agent to said location at
said end of said shaft beyond said at least one balloon.
45. A method according to claim 44 and also comprising providing
heating at said location.
46. A method according to claim 45 and wherein said providing
heating includes locating at least one electrode adjacent said
location.
47. A method according to claim 46 and wherein said at least one
electrode is disposed interiorly of said at least one balloon.
48. A method according to claim 46 and wherein said at least one
electrode is disposed exteriorly of said at least one balloon.
49. A method according to any of claims 45-48 and wherein said
providing heating comprises providing electrical resistive
heating.
50. A method for producing hemostasis at an artery of a patient
having a puncture following arterial catheterization comprising:
introducing a hemostasis device including at least one balloon
mounted adjacent an end of a shaft to a location in the vicinity of
said puncture; and operating at least one RF electrode at said
location at said end of said main shaft beyond said at least one
balloon.
51. A method according to claim 50 and also comprising: supplying a
hemostasis agent to said location at said end of said shaft beyond
said at least one balloon.
52. A method according to either of claims 50 and 51 and wherein
said at least one RF electrode is disposed interiorly of said at
least one balloon.
53. A method according to either of claims 50 and 51 and wherein
said at least one RF electrode is disposed exteriorly of said at
least one balloon.
54. A method for producing hemostasis at an artery of a patient
having a puncture following arterial catheterization comprising:
introducing a hemostasis device including at least one balloon
mounted adjacent an end of a shaft to a location in the vicinity of
said puncture; and operating at least one resistance heating
element at said location at an end of said shaft beyond said at
least one balloon.
55. A method according to claim 54 and also comprising: supplying a
hemostasis agent to said location at said end of said shaft beyond
said at least one balloon.
56. A method according to either of claims 54 and 55 and wherein
said at least one resistance heating element is disposed interiorly
of said at least one balloon.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the priority of U.S. application
Ser. No. 10/358,130, filed Feb. 4, 2003, titled "METHODS AND
APPARATUS FOR HEMOSTASIS FOLLOWING ARTERIAL CATHETERIZATION", and
U.S. application Ser. No. 10/616,887, filed Jul. 10, 2003, titled
"METHODS AND APPARATUS FOR HEMOSTASIS FOLLOWING ARTERIAL
CATHETERIZATION".
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
resistance heating element for accelerating hemostasis, a blood
resistance sensor and a blood resistance indicator, operative to
provide an indication of the resistance at the resistance sensor of
blood undergoing hemostasis.
[0007] In accordance with another preferred embodiment of the
present invention the hemostasis device also includes a power
supply connected to the resistance heating element, the resistance
sensor and the resistance indicator. Additionally, the power supply
is operative to supply a relatively high level current to the
resistance heating element. Alternatively, the power supply is
operative to supply a relatively low level current to the
resistance sensor.
[0008] There is also provided in accordance with another preferred
embodiment of the present invention a method for accelerating
hemostasis of an artery of a patient having a puncture after
arterial catheterization, the method including the steps of
following arterial catheterization, introducing a hemostasis
device, such that a forward end of the hemostasis device lies
exterior of the artery adjacent the puncture, accelerating
hemostasis by heating tissue in the vicinity of the puncture,
thereby shortening the time required for hemostasis and following
hemostasis, removing the hemostasis device from the patient.
[0009] In accordance with another preferred embodiment of the
present invention the method also includes inserting a catheter
introducer into the artery prior to the arterial catheterization
and wherein following the arterial catheterization, the hemostasis
device is introduced through the catheter introducer. In accordance
with yet another preferred embodiment of the present invention the
method also includes measuring the conductivity of blood in the
vicinity of the puncture during hemostasis.
[0010] There is further provided in accordance with another
preferred embodiment of the present invention a method for
monitoring the progress of hemostasis of an artery of a patient
having a puncture after arterial catheterization, the method
including the steps of following arterial catheterization,
introducing a hemostasis device, such that a forward end of the
hemostasis device lies exterior of the artery adjacent the
puncture, during hemostasis, measuring the heat conductivity of
blood in the vicinity of the puncture, thereby to provide an output
indication of the progress of hemostasis and following hemostasis,
removing the hemostasis device from the patient.
[0011] In accordance with another preferred embodiment of the
present invention the method also includes the step of inserting
into an artery a catheter introducer prior to arterial
catheterization and wherein following the arterial catheterization,
the hemostasis device is introduced through the catheter
introducer.
[0012] In accordance with yet another preferred embodiment of the
present invention the method also includes inflating a balloon to
block the puncture, prior to the hemostasis. Additionally, the
method also includes deflating the balloon prior to removing the
hemostasis device.
[0013] There is still further provided in accordance with another
preferred embodiment of the present invention a hemostasis device
including a main shaft, at least one balloon mounted on the main
shaft and at least one electrode, mounted on the main shaft and
being operable to supply an electric current suitable for causing
hemostasis.
[0014] In accordance with another preferred embodiment of the
present invention the at least one balloon includes at least one
anchor balloon, disposed at an end of the main shaft and at least
one peripheral balloon, disposed at a location along the main shaft
exterior to a wall of the main shaft. In accordance with still
another preferred embodiment of the present invention the at least
one peripheral balloon and a wall of an artery are configured to
delimit a region which is subject to hemostasis.
[0015] In accordance with yet another preferred embodiment of the
present invention the hemostasis device also includes an electrical
power source and a control module. In accordance with another
preferred embodiment of the present invention the power source is
an RF power supply. Preferably, the RF power supply is operative to
supply electrical power at RF frequencies within a range of 0.1-10
watts at up to 25 volts. In accordance with another preferred
embodiment of the present invention the control module is operative
to measure at least one of electrical current, blood resistance and
blood temperature. Additionally or alternatively, the control
module is operative to adjust the power supplied by the power
source based on at least one measurement.
[0016] In accordance with still another preferred embodiment of the
present invention the at least one electrode includes a pair of
electrodes.
[0017] There is even further provided in accordance with another
preferred embodiment of the present invention a method for
producing hemostasis at an artery of a patient having a puncture
following arterial catheterization including introducing a
hemostasis device including at least one electrode into the
vicinity of the puncture, supplying an electric current to the at
least one electrode, thereby heating a volume of blood in the
vicinity of the puncture, causing hemostasis and subsequently
removing the hemostasis device from the patient.
[0018] In accordance with another preferred embodiment of the
present invention introducing includes introducing via a catheter
introducer. Additionally or alternatively, the introducing also
includes inflating an anchor balloon attached to an end of the
hemostasis device. In accordance with another preferred embodiment
of the present invention the introducing includes inflating a
peripheral balloon. Additionally, the removing the hemostasis
device includes deflating the peripheral balloon.
[0019] In accordance with still another preferred embodiment of the
present invention the introducing includes positioning the at least
one electrode in close proximity to a volume of blood.
[0020] In accordance with another preferred embodiment of the
present invention the supplying includes supplying electrical power
at RF frequencies. Additionally, the electrical power includes
electrical power in the range of 0.1-10 watts at up to 25 volts.
Alternatively or additionally, the supplying also includes
adjusting the electric current based on a feedback measurement.
[0021] There is also provided in accordance with yet another
preferred embodiment of the present invention a hemostasis device
including a main shaft, at least one balloon mounted on the main
shaft adjacent an end thereof and a hemostasis agent supply conduit
operative to supply a hemostasis agent at a location at the end of
the main shaft beyond the at least one balloon.
[0022] In accordance with another preferred embodiment of the
present invention the hemostasis device also includes at least one
heating assembly operative to provide heating at the location. In
accordance with still another preferred embodiment of the present
invention the at least one heating assembly includes at least one
electrode disposed adjacent the location. In accordance with
another preferred embodiment of the present invention the at least
one electrode is disposed interiorly of the at least one balloon.
Alternatively, the at least one electrode is disposed exteriorly of
the at least one balloon. In accordance with yet another preferred
embodiment of the present invention the at least one heating
assembly includes an electrical resistive heating element. In
accordance with still another preferred embodiment of the present
invention the electrical resistive heating element is disposed
within the at least one balloon.
[0023] There is further provided in accordance with still another
preferred embodiment of the present invention a hemostasis device
including a main shaft, at least one balloon mounted on the main
shaft adjacent an end thereof and at least one RF electrode located
at a location at an end of the main shaft beyond the at least one
balloon.
[0024] In accordance with another preferred embodiment of the
present invention the hemostasis device also includes a hemostasis
agent supply conduit operative to supply a hemostasis agent at a
location at an end of the main shaft beyond the at least one
balloon.
[0025] In accordance with yet another preferred embodiment of the
present invention the at least one RF electrode is disposed
interiorly of the at least one balloon. Alternatively, the at least
one RF electrode is disposed exteriorly of the at least one
balloon.
[0026] There is even further provided in accordance with yet
another preferred embodiment of the present invention a hemostasis
device including a main shaft, at least one balloon mounted on the
main shaft adjacent an end thereof and at least one resistive
heating element located at a location at an end of the main shaft
beyond the at least one balloon.
[0027] In accordance with another preferred embodiment of the
present invention the hemostasis device also includes a hemostasis
agent supply conduit operative to supply a hemostasis agent at a
location at an end of the main shaft beyond the at least one
balloon.
[0028] In accordance with yet another preferred embodiment of the
present invention the at least one resistance heating element is
disposed interiorly of the at least one balloon.
[0029] There is still further provided in accordance with another
preferred embodiment of the present invention a method for
producing hemostasis at an artery of a patient having a puncture
following arterial catheterization including introducing a
hemostasis device including at least one balloon mounted adjacent
an end of a shaft to a location in the vicinity of the puncture and
supplying a hemostasis agent to the location at the end of the
shaft beyond the at least one balloon.
[0030] In accordance with still another preferred embodiment of the
present invention the method also includes providing heating at the
location. In accordance with another preferred embodiment of the
present invention the providing heating includes locating at least
one electrode adjacent the location. Additionally, the at least one
electrode is disposed interiorly of the at least one balloon.
Alternatively, the at least one electrode is disposed exteriorly of
the at least one balloon. In accordance with yet another preferred
embodiment of the present invention the providing heating includes
providing electrical resistive heating.
[0031] There is also provided in accordance with another preferred
embodiment of the present invention a method for producing
hemostasis at an artery of a patient having a puncture following
arterial catheterization including introducing a hemostasis device
including at least one balloon mounted adjacent an end of a shaft
to a location in the vicinity of the puncture and operating at
least one RF electrode at the location at the end of the main shaft
beyond the at least one balloon.
[0032] In accordance with another preferred embodiment of the
present invention the method also includes supplying a hemostasis
agent to the location at the end of the shaft beyond the at least
one balloon. In accordance with yet another preferred embodiment of
the present invention the at least one RF electrode is disposed
interiorly of the at least one balloon. Alternatively, the at least
one RF electrode is disposed exteriorly of the at least one
balloon.
[0033] There is further provided in accordance with yet another
preferred embodiment of the present invention a method for
producing hemostasis at an artery of a patient having a puncture
following arterial catheterization including introducing a
hemostasis device including at least one balloon mounted adjacent
an end of a shaft to a location in the vicinity of the puncture and
operating at least one resistance heating element at the location
at an end of the shaft beyond the at least one balloon.
[0034] In accordance with another preferred embodiment of the
present invention the method also includes supplying a hemostasis
agent to the location at the end of the shaft beyond the at least
one balloon.
[0035] In accordance with still another preferred embodiment of the
present invention the at least one resistance heating element is
disposed interiorly of the at least one balloon.
BRIEF DESCRIPTION OF THE DRAWINGS
[0036] The present invention will be understood and appreciated
more fully from the following detailed description, taken in
conjunction with the drawings in which:
[0037] FIGS. 1A and 1B are simplified pictorial illustrations of
respective first and second modes of operation of a hemostasis
device constructed and operative in accordance with a preferred
embodiment of the present invention;
[0038] FIG. 2 is a simplified pictorial illustration of the
hemostasis device of FIGS. 1A and 1B during hemostasis;
[0039] FIGS. 3A and 3B are graphs illustrating the typical
conductivity levels measured by the hemostasis device when used in
the operating modes shown in FIGS. 1A and 1B, respectively;
[0040] FIG. 4 is a simplified illustration of a hemostasis device
constructed and operative in accordance with a preferred embodiment
of the present invention;
[0041] FIGS. 5A, 5B, 5C, 5D, 5E, 5F, 5G, 5H and 5I are simplified
illustrations of the operation of the apparatus of FIG. 4 in a
patient treatment context;
[0042] FIG. 6 is a simplified illustration of a hemostasis device
constructed and operative in accordance with another preferred
embodiment of the present invention;
[0043] FIGS. 7A, 7B, 7C, 7D, 7E, 7F, 7G, 7H, 7I and 7J 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;
[0044] FIGS. 8A, 8B, 8C and 8D are simplified illustrations of four
different states of inflation of the hemostasis device of FIGS.
7A-7J;
[0045] FIGS. 9A, 9B, 9C, 9D, 9E, 9F, 9G, 9H, 9I and 9J 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;
[0046] FIGS. 10A, 10B, 10C and 10D are simplified illustrations of
four different states of inflation of the hemostasis device of
FIGS. 9A-9J;
[0047] FIGS. 11A, 11B, 11C, 11D, 11E, 11F, 11G, 11H, 11I and 11J
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;
[0048] FIGS. 12A, 12B, 12C and 12D are simplified illustrations of
four different states of inflation of the hemostasis device of
FIGS. 11A-11J;
[0049] FIGS. 13A, 13B, 13C, 13D, 13E, 13F, 13G, 13H, 13I and 13J
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;
[0050] FIGS. 14A, 14B, 14C and 14D are simplified illustrations of
four different states of inflation of the hemostasis device of
FIGS. 13A-13J;
[0051] FIGS. 15A, 15B, 15C, 15D, 15E, 15F, 15G, 15H, 15I and 15J
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; and
[0052] FIGS. 16A, 16B, 16C and 16D are simplified illustrations of
four different states of inflation of the hemostasis device of
FIGS. 15A-15J.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0053] Reference is now made to FIGS. 1A and 1B, which are
simplified pictorial illustrations of a preferred embodiment of a
hemostasis device in respective first and second modes of
operation.
[0054] As seen in FIG. 1A, a hemostasis device 10 is inserted into
a catheter introducer 11, following arterial catheterization and
withdrawal of a catheter (not shown), such that a forward end 12 of
the hemostasis device 10 lies adjacent to and outside a puncture 14
in an artery 16. At least one external balloon 18 is preferably
disposed adjacent catheter introducer 11 and is shown in an
inflated orientation, wherein the balloon 18 forms a skirt
surrounding and sealing puncture 14 from the tissue external
thereto. At this stage blood normally fills artery 16 as well as
puncture 14, as well as the annular volume 20 surrounded by balloon
18 adjacent puncture 14 and forward end 12.
[0055] In accordance with another preferred embodiment of the
present invention, the at least one balloon 18 need not be
provided.
[0056] In accordance with a preferred embodiment of the present
invention, a resistance element 22 is disposed at a forward edge 24
of the forward end 12, and is coupled in series with an external
power supply 26 via conductors 28, which typically extend along the
length of the hemostasis device 10. Preferably, the series
connection includes a resistance indicator 30, which provides an
indication of the resistance at a resistance sensor 32.
[0057] As seen in FIG. 1A, a low level current, typically less than
0.1 ampere, is provided by external power supply 26 to enable the
resistance indicator 30 to monitor the progress of hemostasis, to
allow for timely removal of catheter introducer 11 and hemostasis
device 10 from the patient.
[0058] It is appreciated that the heat conductivity of the blood in
liquid form is measurably different from that of a blood clot
formed during hemostasis, as will be described hereinbelow with
reference to FIGS. 3A and 3B.
[0059] FIG. 1B illustrates the hemostasis device of FIG. 1A in a
second preferred mode of operation. As shown in FIG. 1B, a high
level electrical current, typically greater than 0.1 ampere, is
supplied via the external power supply 26 to resistance element 22.
The provision of this current causes heating of the blood adjacent
to the resistance element 22 and provides for accelerated
hemostasis. The provision of resistance indicator 30, connected to
resistance sensor 32, enables the monitoring of the progress of the
accelerated hemostasis, to allow for regulation of the current
provided to resistance element 22 over time, and to allow timely
removal of catheter introducer 11 and hemostasis device 10 from the
patient.
[0060] It is appreciated that the heat conductivity of the blood in
liquid form is measurably different from that of a blood clot
formed during hemostasis, as will be described hereinbelow with
reference to FIGS. 3A and 3B.
[0061] Reference is now made to FIG. 2, which is a simplified
pictorial illustration of hemostasis device 10 of FIGS. 1A and 1B
during hemostasis.
[0062] FIG. 2 shows the hemostasis device 10 of FIGS. 1A and 1B and
illustrates the different heat conductivity of the blood during the
various stages of hemostasis. As seen in FIG. 2, the blood flowing
through the artery 16 and adjacent the puncture 14 in the artery is
in liquid form, where its heat conductivity is greater than that of
the blood 40 which has begun to coagulate. Blood 40 is in a viscous
form, which has a heat conductivity greater than that of the blood
42, which has already begun to solidify into a blood clot.
Resistance sensor 32 is thus able to measure the process of
coagulation by measuring the heat conductivity of the adjacent
blood.
[0063] Reference is now made to FIGS. 3A and 3B, which are graphs
illustrating the typical conductivity levels measured by the
catheter introducer assembly when used in the operating modes shown
in FIGS. 1A and 1B, respectively.
[0064] FIG. 3A shows the heat conductivity of the blood over time,
in the mode of operation illustrated in FIG. 1A, where the blood is
in a liquid form at time T.sub.0, with relatively high heat
conductivity, where the heat conductivity decreases gradually over
time as the blood forms a clot at time T.sub.H.
[0065] FIG. 3B shows the heat conductivity of the blood over time,
in the mode of operation illustrated in FIG. 1B, where the blood is
heated to accelerate clotting. As seen in FIG. 3B, the heat
conductivity begins at time T.sub.0 in a liquid form with
relatively high heat conductivity, which decreases rapidly as the
blood is heated and the clotting occurs at an accelerated rate.
FIG. 3B also shows the heat conductivity curve over time shown in
FIG. 3A, which clearly illustrates the accelerated hemostasis
described in reference to FIG. 1B hereinabove, where T.sub.HA is
the accelerated hemostasis time and T.sub.H is the non-accelerated
hemostasis time.
[0066] Reference is now made to FIG. 4, which is a simplified
illustration of 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.
[0067] In accordance with a preferred embodiment of the present
invention, hemostasis device 100 comprises a main shaft 102, which
has an outer wall 104 and preferably includes at least three bores.
A first bore, designated generally by reference numeral 110,
extends along the main shaft 102 to an anchor balloon inflation
location 112. A second bore 120 extends along the shaft 102 to a
peripheral balloon inflation location 122. A third bore, designated
generally by reference number 130, contains an electrocoagulation
heating device 132 connected to an electrical power source and
control module 134 by a connector 136.
[0068] Disposed at an end of main shaft 102 at anchor balloon
inflation location 112 is an anchor balloon 140. Anchor balloon 140
is selectably inflated at anchor balloon inflation location 112, as
shown in FIG. 5C, via a stopcock 142 and associated conduit 144 in
fluid communication with main shaft 102 via a passageway 146 formed
in a 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.
[0069] Disposed adjacent the end of second bore 120 in fluid
communication with peripheral balloon inflation location 122,
exterior of wall 104, is a peripheral balloon 160. Peripheral
balloon 160 is selectably inflated at peripheral balloon inflation
location 112, as shown in FIG. 5E, via second bore 120, via a
stopcock 162 and associated conduit 164 that communicate with
second bore 120 via a passageway 166 formed in head element
150.
[0070] In accordance with a preferred embodiment of the present
invention, electrocoagulation heating device 132 comprises an
electrical conductor 170 connected to an electrocoagulation
electrode 176 at an extreme end 178 of third bore 130. A pair of
electrical cables 180 and 182 extends from electrical power source
and control module 134. In the illustrated embodiment, electrical
cable 180 serves as a power supply cable and is connected to
electrocoagulation heating device 132 by connector 136. Electrical
cable 182 serves as a return current cable and is preferably
connected to an electrode 184 attached to a body of a patient.
[0071] Electrical power source and control module 134 preferably
comprises a power supply, preferably an RF power supply source 186,
including a feedback measurement circuit 188. The feedback
measurement circuit 188 is preferably operative to measure current,
blood resistance or blood temperature and thereby determine
progress of hemostasis. The electrical power source and control
module 134 also preferably includes a microprocessor 190, operative
to adjust the power supplied to hemostasis device 100 according to
the blood temperature or other feedback measurement received from
feedback measurement circuit 188, in order to achieve optimal
coagulation of the blood.
[0072] In accordance with a preferred embodiment of the present
invention an operator actuation switch 192 is connected along
electrical cable 180. In accordance with another preferred
embodiment, switch 192 may be obviated and electrical cable 180
connected directly to connector 136.
[0073] Reference is now made to FIGS. 5A-5I, which illustrate
various steps in a preferred mode of operation of the apparatus of
FIG. 4.
[0074] FIG. 5A 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.
[0075] FIG. 5B shows the hemostasis device 100 inserted into 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.
5B, at this stage both anchor balloon 140 and peripheral balloon
160 are deflated.
[0076] Reference is now made to FIG. 5C, which shows initial
inflation of the anchor balloon 140, preferably by use of a syringe
220, communicating with first bore 110 via the interior of head
element 150, stopcock 142 and associated conduit 144. The inflated
anchor balloon 140 preferably has a cusp-type configuration as seen
with particularity in FIG. 5C.
[0077] 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. 5D.
[0078] As seen in FIG. 5E, initial inflation of the peripheral
balloon 160 is effected, preferably by use of a syringe 240
communicating with second bore 120 via head element 150, stopcock
162 and associated conduit 164.
[0079] Thereafter, as seen in FIG. 5F, the anchor balloon 140 is
deflated, preferably by operation of syringe 220, communicating
with first bore 110 via the interior of head element 150, stopcock
142 and associated conduit 144, and the peripheral balloon 160 is
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. 5F, 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.
[0080] At this stage, electric power is supplied to the electrode
176 to provide heating of the blood in region 250, causing
coagulation thereof, as seen in FIG. 5G. In accordance with the
illustrated embodiment of FIG. 4 and as shown in FIG. 5G, the
electric power is provided by actuation of switch 192. In
accordance with another preferred embodiment, switch 192 is
obviated, and the electric power is provided by connecting
electrical cable 180 (FIG. 4) directly to connector 136.
[0081] Preferably, the amount of electrical power supplied along
electrical cable 180 (FIG. 4) from electrical power source and
control module 134 to the electrocoagulation electrode 176 is
between 0.1-10 watts at up to 25 volts at RF frequencies.
[0082] Once acceptable hemostasis has occurred in region 250, the
peripheral balloon 160 is deflated, as shown in FIG. 5H, preferably
by operation of syringe 240 communicating with second bore 120 via
head element 150, stopcock 162 and associated conduit 164.
[0083] Thereafter, the hemostasis device 100 is entirely withdrawn
from the patient, leaving a region 260 of hemostasis outside of
artery 200, as shown in FIG. 5I.
[0084] Reference is now made to FIG. 6, which is a simplified
illustration of a hemostasis device constructed and operative in
accordance with another preferred embodiment of the present
invention. The embodiment of FIG. 6 is similar to that of FIG. 4,
except as described hereinbelow. Elements that occur in both
embodiments are identified by the same reference numerals.
[0085] In the embodiment of FIG. 6, electrocoagulation heating
device 132 comprises a pair of separate electrical conductors 300
extending along third bore 130 connecting electrical power source
and control module 134 to a pair of electrocoagulation electrodes
302 at end 178 of third bore 130. Electrical cables 180 and 182 are
both connected to electrocoagulation heating device 132 by
connector 136. The illustrated embodiment shows connector 136
directly connected to electrical cables 180 and 182.
[0086] In the embodiment of FIG. 6, the electrodes 302 may be
arranged in mutual coaxial arrangement or in mutual side-by-side
arrangement or in any other suitable arrangement.
[0087] Reference is now made to FIGS. 7A, 7B, 7C, 7D, 7E, 7F, 7G,
7H, 7I and 7J, which 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, and to FIGS. 8A, 8B,
8C and 8D, which are simplified illustrations of four different
states of inflation of the hemostasis device.
[0088] FIG. 7A shows a hemostasis device 400 for producing
hemostasis following arterial catheterization in accordance with
another preferred embodiment of the present invention. The
hemostasis device 400 is suitable for insertion via a conventional
catheter introducer (not shown) following completion of
catheterization and removal of the catheter from the catheter
introducer.
[0089] In accordance with a preferred embodiment of the present
invention, hemostasis device 400 comprises a main shaft 402, which
has first and second lumens 404 and 406. First lumen 404 extends
along the main shaft 402 to an anchor balloon inflation location
412. Second lumen 406 extends along the shaft 402 to a peripheral
balloon inflation location 422.
[0090] Disposed at an end of main shaft 402 at anchor balloon
inflation location 412 is an anchor balloon 440. Anchor balloon 440
is selectably inflated, as shown in FIGS. 8A-8D, via a stopcock 442
and associated conduit 444 in fluid communication with main shaft
402 via a passageway 446 formed in a head element 450. Head element
450 is fixed to main shaft 402 at an end thereof opposite the end
at which anchor balloon 440 is located.
[0091] Disposed adjacent the end of main shaft 402, in fluid
communication with peripheral balloon inflation location 422,
exterior of an outer wall 452 thereof, is a peripheral balloon 460.
Peripheral balloon 460 is selectably inflated, as shown in FIGS.
8A-8D, via second lumen 406, via a stopcock 462 and associated
conduit 464 that communicate with second lumen 406 via a passageway
466 formed in head element 450.
[0092] In accordance with a preferred embodiment of the present
invention, a coagulant agent supply conduit 470 extends through the
first lumen 404 and through a bore 472 formed along the length of
head element 450. Coagulant agent supply conduit 470 communicates
at one end thereof with a volume defined by inflation of the
peripheral balloon 460, between the balloon 460 and the outer
surface of an adjacent artery (not shown). At its opposite end,
conduit 470 communicates with a supply of coagulant agent (not
shown) via a stopcock 474 and associated conduit 476.
[0093] FIGS. 7B-7J illustrate various steps in a preferred mode of
operation of the apparatus of FIG. 7A. FIG. 7B illustrates the
hemostasis device 400 about to be inserted into an artery 500 via a
conventional catheter introducer assembly 502, following completion
of a catheterization procedure and withdrawal of a catheter (not
shown) from the catheter introducer assembly 502. The catheter
introducer assembly 502 conventionally includes a catheter
introducer sheath 504.
[0094] FIG. 7C shows the hemostasis device 400 inserted into the
catheter introducer assembly 502 such that the outer end of the
main shaft 402 extends into the artery 500 well beyond the end of
catheter introducer sheath 504. As shown with particularity in FIG.
7C, at this stage both anchor balloon 440 and peripheral balloon
460 are deflated, as seen clearly in FIG. 8A.
[0095] Reference is now made to FIG. 7D, which shows initial
inflation of the anchor balloon 440, preferably by use of a syringe
520, communicating with first lumen 404 via passageway 446
extending through the interior of head element 450, stopcock 442
and associated conduit 444. The inflated anchor balloon 440
preferably has a cusp-type configuration as seen with particularity
in FIGS. 7D and 8B.
[0096] Following inflation of the anchor balloon 440, the catheter
introducer assembly 502 and the hemostasis device 400 are both
withdrawn, such that the catheter introducer sheath 504 is removed
from artery 500 only when the anchor balloon 440 already engages
the interior wall of artery 500 in sealing engagement with the
aperture in the artery 500 through which the catheter introducer
sheath 504 is withdrawn and through which the main shaft 402
presently extends. This stage is shown in FIG. 7E.
[0097] As seen in FIGS. 7F and 8C, initial inflation of the
peripheral balloon 460 is effected, preferably by use of a syringe
540 communicating with second lumen 406 via passageway 466 in head
element 450, stopcock 462 and associated conduit 464.
[0098] Thereafter, as seen in FIGS. 7G and 8D, the anchor balloon
440 is deflated, preferably by operation of syringe 520,
communicating with first lumen 404 via passageway 446 in head
element 450, stopcock 442 and associated conduit 444, and the
peripheral balloon 460 remains fully inflated, which preferably
causes the extreme end of the main shaft 402 to be withdrawn from
the artery 500 to a location lying just outside the artery wall. As
seen in FIG. 7G, peripheral balloon 460 is preferably designed to
allow a limited volume of blood to collect outside of the artery
wall after the anchor balloon 440 is deflated. This volume of blood
is located in a region, indicated by reference numeral 550,
delimited by the engagement of peripheral balloon 460 with the
artery wall.
[0099] At this stage, a coagulant agent is preferably supplied to
the volume of blood at region 550, between the balloon 460 and the
outer surface of artery 500. The coagulant agent is supplied to
region 550 by conduit 470 from a supply of coagulant agent 552 via
stopcock 474 and associated conduit 476, as shown in FIG. 7H.
[0100] Once acceptable hemostasis has occurred in region 550, the
peripheral balloon 460 is deflated, as shown in FIGS. 7I and 8A,
preferably by operation of syringe 540, communicating with second
lumen 406 via passageway 466 in head element 450, stopcock 462 and
associated conduit 464.
[0101] Thereafter, the hemostasis device 400 is entirely withdrawn
from the patient, leaving a region 560 of hemostasis outside of
artery 500, as shown in FIG. 7J.
[0102] Reference is now made to FIGS. 9A, 9B, 9C, 9D, 9E, 9F, 9G,
9H, 9I and 9J, 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, and to FIGS. 10A,
10B, 10C and 10D, which are simplified illustrations of four
different states of inflation of the hemostasis device.
[0103] FIG. 9A shows a hemostasis device 600 for producing
hemostasis following arterial catheterization, in accordance with
yet another preferred embodiment of the present invention. The
hemostasis device 600 is suitable for insertion via a conventional
catheter introducer (not shown) following completion of
catheterization and removal of the catheter from the catheter
introducer.
[0104] In accordance with a preferred embodiment of the present
invention, hemostasis device 600 comprises a main shaft 602, which
has first and second lumens 604 and 606. First lumen 604 extends
along the main shaft 602 to an anchor balloon inflation location
612. Second lumen 606 extends along the shaft 602 to a peripheral
balloon inflation location 622.
[0105] Disposed at an end of main shaft 602 at anchor balloon
inflation location 612 is an anchor balloon 640. Anchor balloon 640
is selectably inflated, as shown in FIGS. 10A-10D, via a stopcock
642 and associated conduit 644 in fluid communication with main
shaft 602 via a passageway 646 formed in a head element 650. Head
element 650 is fixed to main shaft 602 at an end thereof opposite
the end at which anchor balloon 640 is located.
[0106] Disposed adjacent the end of main shaft 602 in fluid
communication with peripheral balloon inflation location 622,
exterior of an outer wall 652 thereof, is a peripheral balloon 660.
Peripheral balloon 660 is selectably inflated, as shown in FIGS.
10A-10D, via second lumen 606, via a stopcock 662 and associated
conduit 664 that communicate with second lumen 606 via a passageway
666 formed in head element 650.
[0107] Additionally, in accordance with a preferred embodiment of
the present invention, an electrical resistance heating element 680
is disposed interiorly of the anchor balloon 640. Preferably, the
resistance heating element 680 is formed of a foil or a wire which
is electrically coupled at opposite ends thereof to electrical
conductors which extend through the main shaft 602. In the
illustrated embodiment, a first conductor 682 is attached to a
first end 684 of resistance heating element 680 and preferably
extends through the first lumen 604, and a second conductor 686 is
attached to a second end 688 of resistance heating element 680 and
extends through the second lumen 606.
[0108] Electrical power is supplied to resistance heating element
680 via a switch 690, which couples first conductor 682 and second
conductor 686 to a source of electrical power. Heating of
resistance heating element 680 enhances hemostasis at the aperture
in the artery.
[0109] Reference is now made to FIGS. 9B-9J, which illustrate
various steps in a preferred mode of operation of the apparatus of
FIG. 9A. FIG. 9B illustrates the hemostasis device 600 about to be
inserted into an artery 700 via a conventional catheter introducer
assembly 702, following completion of a catheterization procedure
and withdrawal of a catheter (not shown) from the catheter
introducer assembly 702. The catheter introducer assembly 702
conventionally includes a catheter introducer sheath 704.
[0110] FIG. 9C shows the hemostasis device 600 inserted into the
catheter introducer assembly 702 such that the outer end of the
main shaft 602 extends into the artery 700 well beyond the end of
catheter introducer sheath 704. As shown with particularity in FIG.
9C, at this stage both anchor balloon 640 and peripheral balloon
660 are deflated, as seen clearly in FIG. 10A.
[0111] Reference is now made to FIG. 9D, which shows initial
inflation of the anchor balloon 640, preferably by use of a syringe
720, communicating with first lumen 604 via passageway 646
extending through the interior of head element 650, stopcock 642
and associated conduit 644. The inflated anchor balloon 640
preferably has a cusp-type configuration as seen with particularity
in FIGS. 9D and 10B.
[0112] Following inflation of the anchor balloon 640, the catheter
introducer assembly 702 and the hemostasis device 600 are both
withdrawn, such that the catheter introducer sheath 704 is removed
from artery 700 only when the anchor balloon 640 already engages
the interior wall of artery 700 in sealing engagement with the
aperture in the artery 700 through which the catheter introducer
sheath 704 is withdrawn and through which the main shaft 602
presently extends. This stage is shown in FIG. 9E.
[0113] As seen in FIGS. 9F and 10C, initial inflation of the
peripheral balloon 660 is effected, preferably by use of a syringe
740 communicating with second lumen 606 via passageway 666 in head
element 650, stopcock 662 and associated conduit 664.
[0114] Thereafter, as seen in FIGS. 9G and 10D, the anchor balloon
640 is deflated, preferably by operation of syringe 720,
communicating with first lumen 604 via passageway 646 in head
element 650, stopcock 642 and associated conduit 644, and the
peripheral balloon 660 remains fully inflated, which preferably
causes the extreme end of the main shaft 602 to be withdrawn from
the artery 700 to a location lying just outside the artery wall. As
seen in FIG. 9G, peripheral balloon 660 is preferably designed to
allow a limited volume of blood to collect outside of the artery
wall after the anchor balloon 640 is deflated. This volume of blood
is located in a region, indicated by reference numeral 750,
delimited by the engagement of peripheral balloon 660 with the
artery wall.
[0115] Preferably at this stage heating of the electrical
resistance heating element 680 is effected, preferably by an
operator closing switch 690, as shown in FIG. 9H. This heating
preferably continues for less than five minutes.
[0116] Once acceptable hemostasis has occurred in region 750, the
peripheral balloon 660 is deflated, as shown in FIGS. 9I and 10A,
preferably by operation of syringe 740, communicating with second
lumen 606 via passageway 666 in head element 650, stopcock 662 and
associated conduit 664.
[0117] Thereafter, the hemostasis device 600 is entirely withdrawn
from the patient, leaving a region 760 of hemostasis outside of
artery 700, as shown in FIG. 9J.
[0118] Reference is now made to FIGS. 11A, 11B, 11C, 11D, 11E, 11F,
11G, 11H, 11I and 11J, 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 and
to FIGS. 12A, 12B, 12C and 12D, which are simplified illustrations
of four different states of inflation of the hemostasis device.
[0119] FIG. 11A shows a hemostasis device 800 for producing
hemostasis following arterial catheterization, in accordance with
yet another preferred embodiment of the present invention. The
hemostasis device 800 is suitable for insertion via a conventional
catheter introducer (not shown) following completion of
catheterization and removal of the catheter from the catheter
introducer.
[0120] In accordance with a preferred embodiment of the present
invention, hemostasis device 800 comprises a main shaft 802, which
has first and second lumens 804 and 806. First lumen 804 extends
along the main shaft 802 to an anchor balloon inflation location
812. Second lumen 806 extends along the shaft 802 to a peripheral
balloon inflation location 822.
[0121] Disposed at an end of main shaft 802 at anchor balloon
inflation location 812 is an anchor balloon 840. Anchor balloon 840
is selectably inflated, as shown in FIGS. 12A-12D, via a stopcock
842 and associated conduit 844 in fluid communication with main
shaft 802 via a passageway 846 formed in a head element 850. Head
element 850 is fixed to main shaft 802 at an end thereof opposite
the end at which anchor balloon 840 is located.
[0122] Disposed adjacent the end of main shaft 802 in fluid
communication with peripheral balloon inflation location 822,
exterior of an outer wall 852 thereof, is a peripheral balloon 860.
Peripheral balloon 860 is selectably inflated, as shown in FIGS.
12A-12D, via second lumen 806, via a stopcock 862 and associated
conduit 864 that communicate with second lumen 806 via a passageway
866 formed in head element 850.
[0123] Additionally, in accordance with a preferred embodiment of
the present invention, a pair of mutually spaced electrodes 880 is
disposed interiorly of the anchor balloon 840. Alternatively,
electrodes 880 are disposed exteriorly of anchor balloon 840.
Preferably, the electrodes 880 are each formed to have a
configuration of a ball or knob and are each electrically coupled
to a corresponding electrical conductor which extend through the
main shaft 802. In the illustrated embodiment, a first conductor
882, which preferably extends through the first lumen 804, is
attached to a first electrode 880 and a second conductor 884 is
attached to a second electrode 880 and extends through the second
lumen 806.
[0124] Electrical power is supplied to electrodes 880 via a switch,
which couples first conductor 882 and second conductor 884 to an RF
power source 890. Heating of electrodes 880 enhances hemostasis at
the aperture in the artery.
[0125] Alternatively, a greater or lesser number of electrodes 880
may be employed. If only a single electrode 880 is provided, a
suitable reference electrode (not shown) is preferably associated
with a patient's body, such as underlying the patient.
[0126] Reference is now made to FIGS. 11B-11J, which illustrate
various steps in a preferred mode of operation of the apparatus of
FIG. 11A. FIG. 11B illustrates the hemostasis device 800 about to
be inserted into an artery 900 via a conventional catheter
introducer assembly 902, following completion of a catheterization
procedure and withdrawal of a catheter (not shown) from the
catheter introducer assembly 902. The catheter introducer assembly
902 conventionally includes a catheter introducer sheath 904.
[0127] FIG. 11C shows the hemostasis device 800 inserted into the
catheter introducer assembly 902 such that the outer end of the
main shaft 802 extends into the artery 900 well beyond the end of
catheter introducer sheath 904. As shown with particularity in FIG.
11C, at this stage both anchor balloon 840 and peripheral balloon
860 are deflated, as seen clearly in FIG. 12A.
[0128] Reference is now made to FIG. 11D, which shows initial
inflation of the anchor balloon 840, preferably by use of a syringe
920, communicating with first lumen 804 via passageway 846
extending through the interior of head element 850, stopcock 842
and associated conduit 844. The inflated anchor balloon 840
preferably has a cusp-type configuration as seen with particularity
in FIGS. 11D and 12B.
[0129] Following inflation of the anchor balloon 840, the catheter
introducer assembly 902 and the hemostasis device 800 are both
withdrawn, such that the catheter introducer sheath 904 is removed
from artery 900 only when the anchor balloon 840 already engages
the interior wall of artery 900 in sealing engagement with the
aperture in the artery 900 through which the catheter introducer
sheath 904 is withdrawn and through which the main shaft 802
presently extends. This stage is shown in FIG. 11E.
[0130] As seen in FIGS. 11F and 12C, initial inflation of the
peripheral balloon 860 is effected, preferably by use of a syringe
940 communicating with second lumen 806 via passageway 866 in head
element 850, stopcock 862 and associated conduit 864.
[0131] Thereafter, as seen in FIGS. 11G and 12D, the anchor balloon
840 is deflated, preferably by operation of syringe 920,
communicating with first lumen 804 via passageway 846 in head
element 850, stopcock 842 and associated conduit 844, and the
peripheral balloon 860 remains fully inflated, which preferably
causes the extreme end of the main shaft 802 to be withdrawn from
the artery 900 to a location lying just outside the artery wall. As
seen in FIG. 11G, peripheral balloon 860 is preferably designed to
allow a limited volume of blood to collect outside of the artery
wall after the anchor balloon 840 is deflated. This volume of blood
is located in a region, indicated by reference numeral 950,
delimited by the engagement of peripheral balloon 860 with the
artery wall.
[0132] Preferably, at this stage, heating of the electrode or
electrodes 880 is effected, preferably by an operator closing the
switch coupling the first conductor 882 and the second conductor
884 to RF power source 890, as seen in FIG. 11H. This heating
preferably continues for less than five minutes.
[0133] Once acceptable hemostasis has occurred in region 950, the
peripheral balloon 860 is deflated, as shown in FIGS. 11I and 12A,
preferably by operation of syringe 940, communicating with second
lumen 806 via passageway 866 in head element 850, stopcock 862 and
associated conduit 864.
[0134] Thereafter, the hemostasis device 800 is entirely withdrawn
from the patient, leaving a region 960 of hemostasis outside of
artery 900, as shown in FIG. 11J.
[0135] Reference is now made to FIGS. 13A, 13B, 13C, 13D, 13E, 13F,
13G, 13H, 13I and 13J, 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 and
to FIGS. 14A, 14B, 14C and 14D, which are simplified illustrations
of four different states of inflation of the hemostasis device.
[0136] FIG. 13A shows a hemostasis device 1000 for producing
hemostasis following arterial catheterization, in accordance with
yet another preferred embodiment of the present invention. The
hemostasis device 1000 is suitable for insertion via a conventional
catheter introducer (not shown) following completion of
catheterization and removal of the catheter from the catheter
introducer.
[0137] In accordance with a preferred embodiment of the present
invention, hemostasis device 1000 comprises a main shaft 1002,
which has first and second lumens 1004 and 1006. First lumen 1004
extends along the main shaft 1002 to an anchor balloon inflation
location 1012. Second lumen 1006 extends along the shaft 1002 to a
peripheral balloon inflation location 1022.
[0138] Disposed at an end of main shaft 1002 at anchor balloon
inflation location 1012 is an anchor balloon 1040. Anchor balloon
1040 is selectably inflated, as shown in FIGS. 14A-14D, via a
stopcock 1042 and associated conduit 1044 in fluid communication
with main shaft 1002 via a passageway 1046 formed in a head element
1050. Head element 1050 is fixed to main shaft 1002 at an end
thereof opposite the end at which anchor balloon 1040 is
located.
[0139] Disposed adjacent the end of main shaft 1002 in fluid
communication with peripheral balloon inflation location 1022,
exterior of an outer wall 1052 thereof, is a peripheral balloon
1060. Peripheral balloon 1060 is selectably inflated, as shown in
FIGS. 14A-14D, via second lumen 1006, via a stopcock 1062 and
associated conduit 1064 that communicate with second lumen 1006 via
a passageway 1066 formed in head element 1050.
[0140] In accordance with a preferred embodiment of the present
invention a coagulant agent supply conduit 1070 extends through the
first lumen 1004 and through a bore 1072 formed along the length of
head element 1050. Coagulant agent supply conduit 1070 communicates
at one end thereof with a volume defined by inflation of the
peripheral balloon 1060, between the balloon 1060 and the outer
surface of an adjacent artery (not shown). At its opposite end,
conduit 1070 communicates with a supply of coagulant agent (not
shown) via a stopcock 1074 and associated conduit 1076.
[0141] Additionally, in accordance with a preferred embodiment of
the present invention, an electrical resistance heating element
1080 is disposed interiorly of the anchor balloon 1040. Preferably,
the resistance heating element 1080 is formed of a foil or a wire
which is electrically coupled at opposite ends thereof to
electrical conductors which extend through the main shaft 1002. In
the illustrated embodiment, a first conductor, attached to a first
end 1084 of resistance heating element 1080, is defined by or on
the coagulant agent supply conduit 1070, which preferably extends
through the first lumen 1004, and a second conductor 1086 is
attached to a second end 1088 of resistance heating element 1080
and extends through the second lumen 1006.
[0142] Electrical power is supplied to resistance heating element
1080 via a switch 1090, which couples the first conductor, defined
by conduit 1070, and second conductor 1086 to a source of
electrical power. Heating of resistance heating element 1080
enhances hemostasis at the aperture in the artery. The operation of
the resistance heating element 1080 as aforesaid is advantageously
combined in this embodiment with the provision of a coagulation
agent as described hereinabove.
[0143] Reference is now made to FIGS. 13B-13J, which illustrate
various steps in a preferred mode of operation of the apparatus of
FIG. 13A. FIG. 13B illustrates the hemostasis device 1000 about to
be inserted into an artery 1100 via a conventional catheter
introducer assembly 1102, following completion of a catheterization
procedure and withdrawal of a catheter (not shown) from the
catheter introducer assembly 1102. The catheter introducer assembly
1102 conventionally includes a catheter introducer sheath 1104.
[0144] FIG. 13C shows the hemostasis device 1000 inserted into the
catheter introducer assembly 1102 such that the outer end of the
main shaft 1002 extends into the artery 1100 well beyond the end of
catheter introducer sheath 1104. As shown with particularity in
FIG. 13C, at this stage both anchor balloon 1040 and peripheral
balloon 1060 are deflated, as seen clearly in FIG. 14A.
[0145] Reference is now made to FIG. 13D, which shows initial
inflation of the anchor balloon 1040, preferably by use of a
syringe 1120, communicating with first lumen 1004 via passageway
1046 extending through the interior of head element 1050, stopcock
1042 and associated conduit 1044. The inflated anchor balloon 1040
preferably has a cusp-type configuration as seen with particularity
in FIGS. 13D and 14B.
[0146] Following inflation of the anchor balloon 1040, the catheter
introducer assembly 1102 and the hemostasis device 1000 are both
withdrawn, such that the catheter introducer sheath 1104 is removed
from artery 1100 only when the anchor balloon 1040 already engages
the interior wall of artery 1100 in sealing engagement with the
aperture in the artery 1100 through which the catheter introducer
sheath 1104 is withdrawn and through which the main shaft 1002
presently extends. This stage is shown in FIG. 13E.
[0147] As seen in FIGS. 13F and 14C, initial inflation of the
peripheral balloon 1060 is effected, preferably by use of a syringe
1140 communicating with second lumen 1006 via passageway 1066 in
head element 1050, stopcock 1062 and associated conduit 1064.
[0148] Thereafter, as seen in FIGS. 13G and 14D, the anchor balloon
1040 is deflated, preferably by operation of syringe 1120,
communicating with first lumen 1004 via passageway 1046 in head
element 1050, stopcock 1042 and associated conduit 1044, and the
peripheral balloon 1060 remains fully inflated, which preferably
causes the extreme end of the main shaft 1002 to be withdrawn from
the artery 1100 to a location lying just outside the artery wall.
As seen in FIG. 13G, peripheral balloon 1060 is preferably designed
to allow a limited volume of blood to collect outside of the artery
wall after the anchor balloon 1040 is deflated. This volume of
blood is located in a region, indicated by reference numeral 1150,
delimited by the engagement of peripheral balloon 1060 with the
artery wall.
[0149] At this stage, a coagulant agent is preferably supplied to
the volume of blood at region 1150, between the balloon 1060 and
the outer surface of artery 1100. The coagulant agent is supplied
to region 1150 by conduit 1070 from a supply of coagulant agent
1152 via stopcock 1074 and associated conduit 1076, as shown in
FIG. 13H.
[0150] Preferably also at this stage, heating of the electrical
resistance heating element 1080 is effected, preferably by an
operator closing switch 1090. This heating preferably continues for
less than five minutes.
[0151] Once acceptable hemostasis has occurred in region 1150, the
peripheral balloon 1060 is deflated, as shown in FIGS. 13I and 14A,
preferably by operation of syringe 1140, communicating with second
lumen 1006 via passageway 1066 in head element 1050, stopcock 1062
and associated conduit 1064.
[0152] Thereafter, the hemostasis device 1000 is entirely withdrawn
from the patient, leaving a region 1160 of hemostasis outside of
artery 1100, as shown in FIG. 13J.
[0153] Reference is now made to FIGS. 15A, 15B, 15C, 15D, 15E, 15F,
15G, 15H, 15I and 15J, 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 and
to FIGS. 16A, 16B, 16C and 16D, which are simplified illustrations
of four different states of inflation of the hemostasis device.
[0154] FIG. 15A shows a hemostasis device 1200 for producing
hemostasis following arterial catheterization, in accordance with
yet another preferred embodiment of the present invention. The
hemostasis device 1200 is suitable for insertion via a conventional
catheter introducer (not shown) following completion of
catheterization and removal of the catheter from the catheter
introducer.
[0155] In accordance with a preferred embodiment of the present
invention, hemostasis device 1200 comprises a main shaft 1202,
which has first and second lumens 1204 and 1206. First lumen 1204
extends along the main shaft 1202 to an anchor balloon inflation
location 1212. Second lumen 1206 extends along the shaft 1202 to a
peripheral balloon inflation location 1222.
[0156] Disposed at an end of main shaft 1202 at anchor balloon
inflation location 1212 is an anchor balloon 1240. Anchor balloon
1240 is selectably inflated, as shown in FIGS. 16A-16D, via a
stopcock 1242 and associated conduit 1244 in fluid communication
with main shaft 1202 via a passageway 1246 formed in a head element
1250. Head element 1250 is fixed to main shaft 1202 at an end
thereof opposite the end at which anchor balloon 1240 is
located.
[0157] Disposed adjacent the end of main shaft 1202 in fluid
communication with peripheral balloon inflation location 1222,
exterior of an outer wall 1252 thereof, is a peripheral balloon
1260. Peripheral balloon 1260 is selectably inflated, as shown in
FIGS. 16A-16D, via second lumen 1206, via a stopcock 1262 and
associated conduit 1264 that communicate with second lumen 1206 via
a passageway 1266 formed in head element 1250.
[0158] In accordance with a preferred embodiment of the present
invention a coagulant agent supply conduit 1270 extends through the
first lumen 1204 and through a bore 1272 formed in head element
1250. Coagulant agent supply conduit 1270 communicates at one end
thereof, via a coagulant agent aperture 1273, with a volume defined
by inflation of the peripheral balloon 1260, between the balloon
1260 and the outer surface of an adjacent artery (not shown). At
its opposite end, conduit 1270 communicates with a supply of
coagulant agent (not shown) via a stopcock 1274 and associated
conduit 1276. Coagulant agent aperture 1273 is clearly shown in
FIGS. 16A-16D.
[0159] Additionally, in accordance with a preferred embodiment of
the present invention, a pair of mutually spaced electrodes 1280 is
disposed interiorly of the anchor balloon 1240. Alternatively,
electrodes 1280 are disposed exteriorly of anchor balloon 1240.
Preferably, the electrodes 1280 are each formed to have a
configuration of a ball or knob and are each electrically coupled
to a corresponding electrical conductor which extend through the
main shaft 1202. In the illustrated embodiment, a first conductor,
attached to a first electrode 1280, is defined by or on the
coagulant agent supply conduit 1270, which preferably extends
through the first lumen 1204, and a second conductor 1286 is
attached to a second electrode 1280 and extends through the second
lumen 1206.
[0160] Electrical power is supplied to electrodes 1280 via a
switch, which couples the first conductor and the second conductor
1286 to an RF power source 1290. Heating of electrodes 1280
enhances hemostasis at the aperture in the artery. The operation of
the electrodes 1280 as aforesaid is advantageously combined in this
embodiment with the provision of a coagulation agent as described
hereinabove.
[0161] Alternatively, a greater or lesser number of electrodes 1280
may be employed. If only a single electrode 1280 is provided, a
suitable reference electrode (not shown) is preferably associated
with a patient's body, such as underlying the patient.
[0162] Reference is now made to FIGS. 15B-15J, which illustrate
various steps in a preferred mode of operation of the apparatus of
FIG. 15A. FIG. 15B illustrates the hemostasis device 1200 about to
be inserted into an artery 1300 via a conventional catheter
introducer assembly 1302, following completion of a catheterization
procedure and withdrawal of a catheter (not shown) from the
catheter introducer assembly 1302. The catheter introducer assembly
1302 conventionally includes a catheter introducer sheath 1304.
[0163] FIG. 15C shows the hemostasis device 1200 inserted into the
catheter introducer assembly 1302 such that the outer end of the
main shaft 1202 extends into the artery 1300 well beyond the end of
catheter introducer sheath 1304. As shown with particularity in
FIG. 15C, at this stage both anchor balloon 1240 and peripheral
balloon 1260 are deflated, as seen clearly in FIG. 16A.
[0164] Reference is now made to FIG. 15D, which shows initial
inflation of the anchor balloon 1240, preferably by use of a
syringe 1320, communicating with first lumen 1204 via passageway
1246 extending through the interior of head element 1250, stopcock
1242 and associated conduit 1244. The inflated anchor balloon 1240
preferably has a cusp-type configuration as seen with particularity
in FIGS. 15D and 16B.
[0165] Following inflation of the anchor balloon 1240, the catheter
introducer assembly 1302 and the hemostasis device 1200 are both
withdrawn, such that the catheter introducer sheath 1304 is removed
from artery 1300 only when the anchor balloon 1240 already engages
the interior wall of artery 1300 in sealing engagement with the
aperture in the artery 1300 through which the catheter introducer
sheath 1304 is withdrawn and through which the main shaft 1202
presently extends. This stage is shown in FIG. 15E.
[0166] As seen in FIGS. 15F and 16C, initial inflation of the
peripheral balloon 1260 is effected, preferably by use of a syringe
1340 communicating with second lumen 1206 via passageway 1266 in
head element 1250, stopcock 1262 and associated conduit 1264.
[0167] Thereafter, as seen in FIGS. 15G and 16D, the anchor balloon
1240 is deflated, preferably by operation of syringe 1320,
communicating with first lumen 1204 via passageway 1246 in head
element 1250, stopcock 1242 and associated conduit 1244, and the
peripheral balloon 1260 remains fully inflated, which preferably
causes the extreme end of the main shaft 1202 to be withdrawn from
the artery 1300 to a location lying just outside the artery wall.
As seen in FIG. 15G, peripheral balloon 1260 is preferably designed
to allow a limited volume of blood to collect outside of the artery
wall after the anchor balloon 1240 is deflated. This volume of
blood is located in a region, indicated by reference numeral 1350,
delimited by the engagement of peripheral balloon 1260 with the
artery wall.
[0168] At this stage, a coagulant agent is preferably supplied to
the volume of blood at region 1350, between the balloon 1260 and
the outer surface of artery 1300. The coagulant agent is supplied
to region 1350 by conduit 1270, via coagulant agent aperture 1273
from a supply of coagulant agent 1352 via stopcock 1274 and
associated conduit 1276, as shown in FIG. 15H.
[0169] Preferably, also at this stage, heating of the electrode or
electrodes 1280 is effected, preferably by an operator closing the
switch coupling the first conductor and the second conductor 1286
to RF power source 1290, as seen in FIG. 15H. This heating
preferably continues for less than five minutes.
[0170] Once acceptable hemostasis has occurred in region 1350, the
peripheral balloon 1260 is deflated, as shown in FIGS. 15I and 16A,
preferably by operation of syringe 1340, communicating with second
lumen 1206 via passageway 1266 in head element 1250, stopcock 1262
and associated conduit 1264.
[0171] Thereafter, the hemostasis device 1200 is entirely withdrawn
from the patient, leaving a region 1360 of hemostasis outside of
artery 1300, as shown in FIG. 15J.
[0172] 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.
* * * * *