U.S. patent application number 11/754722 was filed with the patent office on 2007-09-20 for method and device for accessing a pericardial space.
This patent application is currently assigned to G&L CONSULTING, LLC. Invention is credited to Mark Gelfand, Howard Levin.
Application Number | 20070219525 11/754722 |
Document ID | / |
Family ID | 36757619 |
Filed Date | 2007-09-20 |
United States Patent
Application |
20070219525 |
Kind Code |
A1 |
Gelfand; Mark ; et
al. |
September 20, 2007 |
METHOD AND DEVICE FOR ACCESSING A PERICARDIAL SPACE
Abstract
A method for accessing a pericardial space of a heart of a
mammalian patient is disclosed comprising: guiding a catheter
through a coronary sinus of the heart and to a cardiac vein;
advancing said catheter to a distal segment of the cardiac vein;
intentionally puncturing the vein with the catheter to access the
pericardial space, and performing a therapy or a diagnostic
procedure using the catheter an the puncture in the vein and using
the pericardial space.
Inventors: |
Gelfand; Mark; (New York,
NY) ; Levin; Howard; (Teaneck, NJ) |
Correspondence
Address: |
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON
VA
22203
US
|
Assignee: |
G&L CONSULTING, LLC
3960 Broadway
New York
NY
10032
|
Family ID: |
36757619 |
Appl. No.: |
11/754722 |
Filed: |
May 29, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11275792 |
Jan 30, 2006 |
7226440 |
|
|
11754722 |
May 29, 2007 |
|
|
|
60648277 |
Jan 31, 2005 |
|
|
|
Current U.S.
Class: |
604/508 |
Current CPC
Class: |
A61M 25/1011 20130101;
A61M 2025/1052 20130101 |
Class at
Publication: |
604/508 |
International
Class: |
A61M 31/00 20060101
A61M031/00 |
Claims
1. A method for accessing a pericardial space of a heart of a
mammalian patient comprising: advancing a catheter through a
coronary sinus of the heart, a cardiac vein and to a distal branch
of the cardiac vein; intentionally puncturing the distal branch of
the cardiac vein and a serous layer of a pericardium with the
catheter to access the pericardial space between the serous and a
fibrous layer of the pericardium, and performing a therapy or a
diagnostic procedure in the pericardial space using the catheter
extending through the puncture into the pericardial space.
2. A method as in claim 1 further comprising separating fibrous and
serous layers of the pericardium no later than when puncturing the
distal branch.
3. A method as in claim 2 further comprising inserting a tip of the
catheter between the fibrous and serous layers of pericardium.
4. A method as in claim 1 further comprising establishing fluid
communication with the pericardial space through a lumen in the
catheter, and infusing or withdrawing a fluid in or from the
pericardial space and from or to the lumen.
5. A method as in claim 4 further comprising sealing the punctured
distal branch.
6. A method as in claim 5 wherein sealing the branch occurs before
the infusion or withdrawal of fluid.
7. A method as in claim 1 wherein the therapy or diagnostic
procedure includes delivery of drugs to the pericardial space.
8. A method as in claim 1 wherein the therapy or diagnostic
procedure includes delivery of a genetic agent to the pericardial
space.
9. A method as in claim 1 wherein the therapy or diagnostic
procedure includes placement of electrodes into the pericardial
space.
10. A method as in claim 1 wherein the therapy or diagnostic
procedure includes infusion of fluid into the pericardial
space.
11. A method for accessing a pericardial space of a heart of a
mammalian patient comprising: advancing a catheter through a
coronary sinus of the heart, a cardiac vein and to a distal branch
of the cardiac vein; distending the distal branch of the cardiac
vein; intentionally puncturing the distal branch of the cardiac
vein with the catheter to access the pericardial space of the
pericardium, and performing a therapy or a diagnostic procedure in
the pericardial space using the catheter extending through the
puncture into the pericardial space.
12. A method as in claim 11 wherein distending the distal branch
separates fibrous and serous layers of the pericardium to
facilitate access to the pericardial space.
13. A method as in claim 11 wherein an expansion device attached to
the catheter expands to distend the distal branch.
14. A method as in claim 13 wherein the expansion device is a
balloon.
15. A method as in claim 11 wherein the distal branch is distended
before puncturing the distal branch.
16. A method for inserting an access device into a pericardial
space of a heart of a mammalian patient comprising: advancing a
catheter through a coronary sinus of the heart, a cardiac vein and
to a distal branch of the cardiac vein; distending the distal
branch of the cardiac vein; extending the access device from a
distal end of the catheter to intentionally puncture the distal
branch of the cardiac vein with the access device to access the
pericardial space of the pericardium, and inserting the access
device into the pericardial space; removing the catheter from the
patient and leaving at least a distal tip of the access device in
at least one of the pericardial space and distal branch of the
cardiac vein.
17. A method as in claim 16 wherein the access device includes at
least one of a wire, a fluid infusion catheter and an electrode
lead.
18. A method as in claim 16 wherein distending includes infusing a
fluid into the pericardial space to expand the pericardial
space.
19. A method as in claim 16 wherein further comprising extending
the access device from a lumen in the catheter to puncture the
distal branch of the cardiac vein.
20. A method as in claim 19 wherein the catheter extends from the
lumen through a side opening in the catheter.
Description
CROSS RELATED APPLICATIONS
[0001] This application is a continuation of application Ser. No.
11/275,792 filed Jan. 30, 2006 and claims the benefit of the filing
date of U.S. Provisional Patent Application 60/648,277 filed Jan.
31, 2005, both applications are incorporated herein by
reference.
BACKGROUND OF THE INVENTION
[0002] This invention relates to a method for accessing pericardial
space of the heart for delivery of medication or other therapy. It
also relates to intravascular catheters for accessing the
pericardial space of the heart.
[0003] The pericardium (also called pericardial sac or pericardial
complex) consists of an outer fibrous layer and an inner serous
layer. The fibrous pericardium is a flask-shaped, tough outer sac
with attachments to the diaphragm, sternum, and costal cartilage.
The serous layer is thin and is adjacent to the surface of the
heart. For the purpose of this disclosure references to the
pericardial membrane mean the fibrous pericardium and references to
the pericardial space mean the space between the outer (fibrous)
and the inner (serous) layers.
[0004] The pericardium serves as a protective barrier from the
spread of infection or inflammation from adjacent structures. The
distendable pericardial space produced by these layers normally
contains approximately 20 cubic centimeters (cc) of fluid with
electrolyte and protein profiles similar to plasma. Fluid serves as
a lubricant to allow unimpeded motion of the heart inside the sack.
Approximately 120 cc of additional fluid can accumulate in the
pericardium without an increase in pressure. Further fluid
accumulation can result in marked increases in pericardial
pressure, eliciting decreased cardiac output and hypotension
(cardiac tamponade).
[0005] Access to the pericardial space is desirable to provide a
variety of cardiac therapies, including delivery of drugs or
genetic agents, placement of electrodes, removal or infusion of
fluid for diagnostic analysis or therapy, or other purposes. A
variety of mechanisms have been developed for accessing the
pericardial space, ranging from a simple puncture by a large bore
needle to intricate catheter or cannula based systems provided with
sealing and anchoring mechanisms.
[0006] Access to the pericardial space in the prior art has been
disclosed as: piercing the pericardium from outside or inside the
heart, and piercing the wall of a heart chamber. Prior mechanisms
adapted to access the pericardial space by piercing the heart
chamber include U.S. Pat. No. 5,797,870 issued to March et al,
which discloses a catheter with a hollow helical needle to pierce
the wall of a heart chamber. Particularly in the context of access
to the pericardial space via the right atrium, it has been proposed
that the transvenous catheter pierce the right arterial wall, as in
U.S. Pat. No. 4,946,457 issued to Elliot and that the catheter
pierce the right arterial appendage as in U.S. Pat. No. 5,269,326
issued to Verrier. Access to the pericardial space from the
exterior of the body, accomplished by passing a cannula or catheter
type device through the chest wall and thereafter passing the
cannula or catheter through the pericardium into the pericardial
space is disclosed in U.S. Pat. No. 5,827,216 issued to Igo, U.S.
Pat. No. 5,336,252 issued to Cohen. These methods and mechanisms
are not best suited to access the pericardial space without surgery
and without piercing the wall of the heart so as to avoid danger of
excessive bleeding.
SUMMARY OF THE INVENTION
[0007] The inventive method, in one embodiment, comprises accessing
the pericardial space with a catheter guided to a coronary sinus
and into a coronary (cardiac) vein via the mammalian patient's
venous system. The catheter tip is advanced into a smaller distal
(distant) branch of the coronary venous tree that can be
sacrificed. The distal branch can be occluded with a catheter tip
balloon and isolated from the larger coronary venous tree. Fluid
can be infused through a catheter lumen to swell and extend the
isolated distal branch. A needle or a wire is introduced into the
resulting bubble formed by the extended isolated distal branch. An
access device such as a needle, wire or catheter pierces the wall
of the distal vein branch and enters the pericardial space.
[0008] Following the puncture, the distal vein branch can be filled
via a catheter with a clotting agent, biologic glue (bioglue) or
other sealing material to facilitate termination of bleeding. After
the distal branch of the vein is sealed, the balloon can be
deflated and the catheter removed if desired. There will be no
significant bleeding from the vein into the pericardial space. The
access device can be safely left in place with the distal tip of it
residing in the pericardial space and the proximal end available
for fluid communication with drug delivery devices, to fill
pericardial space with flowable material or to drain fluid. A
catheter or an electrode lead can be placed this way in the
pericardial space and connected to an implantable pump, a pacemaker
or an electric stimulator for a variety of applicable
therapies.
[0009] A method for accessing a pericardial space of a heart of a
mammalian patient is disclosed comprising: guiding a catheter
through a coronary sinus of the heart and to a cardiac vein;
advancing said catheter to a distal segment of the cardiac vein;
intentionally puncturing the vein with the catheter to access the
pericardial space, and performing a therapy or a diagnostic
procedure using the catheter in the puncture in the vein and using
the pericardial space. The method may further comprises extending
an access device of the catheter through the puncture and into the
pericardial space; and delivering a therapy to the pericardial
space through the catheter and the puncture, wherein the therapy
includes at least one of delivery of drugs or genetic agents to the
pericardial space, placement of electrodes into the pericardial
space, removal or infusion of fluid from the pericardial space. The
method may further comprise permanently sealing the distal segment
with the catheter and/or temporary sealing the distal segment by
expanding a balloon at a distal end of the catheter and thereafter
puncturing the vein. The permanent sealing the distal segment may
be by infusion of a bioglue or a clotting agent or delivery of heat
or RF energy. The method may comprise expanding an expandable
device at a distal section of the catheter to distend the distal
segment of the cardiac vein and then extending an access puncturing
and into the pericardial space, and thereafter extending an access
device from the catheter to puncture the vein.
[0010] A method for transvenously accessing a pericardial space
between a heart and a pericardium in a mammalian patient has been
developed, said method comprising: guiding a catheter downstream
through a coronary sinus and coronary vein to a region adjacent the
pericardial space, and intentionally accessing the pericardial
space with the catheter by penetrating the coronary vein, wherein
the catheter is inserted into a peripheral vein and guided to the
coronary sinus. The method may further comprise sealing the
coronary vein, wherein the seal is a temporary seal formed by
expanding a distal section of the catheter in the coronary vein or
a permanent seal of a distal segment of the coronary vein and the
catheter extends to the distal segment and is retracted from the
patient after sealing the distal segment. The permanent sealing is
achieved with an infusion of a bioglue or a clotting agent or
delivery of heat or RF energy.
[0011] The method may further comprise extending an access device
of the catheter through the puncture and into the pericardial
space, and delivering a therapy to the pericardial space through
the catheter and the puncture. The therapy may include at least one
of delivery of drugs or genetic agents to the pericardial space,
placement of electrodes into the pericardial space, removal or
infusion of fluid from the pericardial space.
[0012] The method may include accessing the pericardial space by
extending an access device from the catheter between a serous layer
and fibrous layer of a pericardium of the heart. The serous layer
and fibrous layers are separated by distending a distal segment of
the coronary vein with the catheter, such as using a balloon on the
catheter. The vein can be punctured after the layers are
separated.
SUMMARY OF THE DRAWINGS
[0013] A preferred embodiment and best mode of the invention is
illustrated in the attached drawings that are described as
follows:
[0014] FIG. 1 is a perspective view of a distal end of a catheter
inserted into a venous tree of a human heart to access the
pericardial space via a distal coronary vein branch.
[0015] FIGS. 2A, 2B, 2C, 2D, 2E and 2F are enlarged cross-sectional
views of the pericardial space to show the steps of inserting the
catheter into the space (2A), inflating a balloon on the catheter
to temporarily seal the space (2B), inserting an access device that
can be a therapeutic device into the pericardial space between the
pericardial membrane and heart muscle wall (2C), injecting a
permanent sealing material in the pericardial space (2D and 2E),
and removing the catheter while leaving the device in the
pericardial space (2F).
[0016] FIG. 3 illustrates an alternative embodiment of the catheter
having multiple lumens (shown in cross-section) and multiple
balloons wherein the catheter is inserted into the pericardial
space.
[0017] FIG. 4 is a side view of alternative catheter having a side
port through which exits the access device into the pericardial
space.
DETAILED DESCRIPTION OF THE INVENTION
[0018] For the proposed clinical use, the capability of the
preferred embodiment of the invention is to access the pericardial
space of the heat to deliver therapy such as drug substances and to
install catheters and electrode leads in that space.
[0019] FIG. 1 illustrates a guiding catheter 102 in the process of
accessing the pericardial space 108 formed by the heart 100 and the
pericardial membrane 101, which is the outer fibrous layer of the
pericardium. The catheter 102 is introduced into the coronary vein
103 through the coronary sinus of the heart (not shown). Both
femoral (from below) and jugular (from the top) venous approaches
are possible to access coronary sinus via a percutaneous puncture
of a peripheral vein. These approaches are commonly used in the
field of invasive cardiology. Catheters for Coronary Sinus
catheterization and temporary occlusion are known in invasive
cardiology. The distal catheter tip 106 is shown inside the branch
107. A smaller access device 109 is shown with its tip penetrating
inside the pericardial space 108. In this preferred embodiment the
access device 109 is a catheter for fluid delivery.
[0020] The catheter tip 106 has an opening for the passage of the
access catheter 109. The access catheter 109 is in the fluid
communication with the pericardial space. The proximal ends of the
catheters 102 and 109 can be connected to various extracorporeal
medical devices used to inflate and deflate the balloon 105 and for
delivery and withdrawal of substances (not shown). Catheter 102 is
a flexible hollow tube that can have multiple lumens inside. The
balloon 105 is used to occlude the lumen of the coronary vein to
isolate the distal vein branch 107. The catheter tip 106 traverses
the wall of the branch 107 at the puncture point 104. It is
understood that the access catheter 109 is shown as an
illustration. The access can be using any therapeutic device suited
for the particular therapy: an electrode lead such as an epicardial
pacemaker lead with electrodes known in the field of pacemakers and
cardiac pacing, a guidewire or a drug delivery catheter.
[0021] FIGS. 2A to 2F illustrate the steps of the method for
accessing the pericardial space using the catheter and the access
device. In FIG. 2A, the guiding catheter 102 is shown inserted into
the vein 103. The balloon 105 is shown deflated. The distal branch
107 of the vein 103 is not yet isolated. Pericardial membrane 101
tightly adheres to the surface of the heart muscle wall 110. The
vein 103 occupies space between the membrane 101 and the heart wall
110 and is therefore inside the pericardial space.
[0022] In FIG. 2B, the guiding catheter 102 is shown inserted into
the vein 103. The balloon 105 is inflated. The distal branch 107 of
the vein 103 is now isolated from venous circulation by the
balloon. The inflation of the balloon distended the pericardial
membrane 101. The membrane is less tightly adherent to the heart
wall 110. The pericardial space 108 is expanded around the balloon
and becomes more accessible. This local pericardial space so gained
is referred to as a bubble. Physiologic fluid such as saline can be
infused into the distal branch 107 at this stage of the procedure
to increase the bubble size by distending the walls of the distal
branch of the vein 107. The fluid can be a viscous biocompatible
fluid or a gel that will not run off as quickly as saline and will
allow the physician more time to take advantage of the bubble.
[0023] FIG. 2C shows the access device 109 puncturing the wall of
the distal vein branch 107 in the puncture location 104. The access
device 109 may be a flexible wire or a cannula equipped with a
relatively sharp tip. The tip need not be very sharp since it is
not intended to penetrate the tough pericardial membrane 101. It is
only intended to puncture soft and less resilient wall of the vein
and serous pericardium membrane adherent to the wall of the heart.
The pericardium (also called pericardial sac or pericardial
complex) consists of an outer fibrous layer 101 and an inner serous
layer 113. The access device 109 need not be very resilient either,
since it is expected that it will be deflected from the fibrous
membrane 101. The tip of the device 109 may curl into a pigtail
(not shown) after substantially exiting from the puncture to
prevent accidental perforation of the pericardial membrane. It is
expected that a medical imaging modality will be used to ensure
that the access device is in the pericardial space and did not
penetrate the chest. The physician needs not to be excessively
concerned with damage to the vein 107 since at the end of the
procedure it will be sacrificed and sealed.
[0024] FIG. 2D shows the bubble pericardial space 108 further
temporarily enlarged by the infusion of fluid 112 into the distal
vein 107. The guiding catheter 102 is equipped with additional
internal lumen 111 suitable for infusion of fluids. The fluid 112
can contain a radiocontrast agent to enhance visualization of the
bubble using the standard X-ray fluoroscopic technique commonly
used by interventional radiologists and cardiologists. If an MRI or
ultrasound visualization is used, appropriate contrast agents are
also available. The purpose of this step is to further stretch and
detach the membrane 101 from the heart wall.
[0025] It is understood that the access device 109 can be a
guidewire and that several therapeutic devices can be introduced
into the pericardial space using it as a guide. The puncture 104
can be gradually enlarged to accommodate larger devices. These
"over-the-wire" exchange techniques are widely used in invasive
cardiology and radiology.
[0026] FIG. 2E shows the step of sealing the puncture site 104 in
the wall of the vein 102. The access device (for example drug
delivery catheter) 109 is positioned in the pericardial space and
can be used to deliver therapy to the heart, but the balloon 105 is
not yet deflated and the guiding catheter 102 should not be
substantially pulled back yet in fear of significant bleeding. To
seal the puncture a sealing agent such as for example a clotting
agent or a bioglue 112 is injected into the distal vein branch 107
through the lumen 111 of the catheter 102. Alternatively the distal
tip of the catheter 102 can be equipped with electrodes and RF
energy can be used to cauterize and seal the distal vein 107.
Alternatively heat can be delivered to the blood in the vein to
clot it rapidly. Catheters to seal veins are known and used, for
example, to treat veins in the legs of patients for cosmetic
reasons. It can be envisioned that, after the sealing process is
started, the balloon 105 is deflated and that the catheter 102 is
slowly pulled back as the sealing agent is injected or the vein is
sealed by the application of energy.
[0027] FIG. 2F shows the vein 103 after withdrawal of the
introducer catheter 102. The access catheter 109 is left in place
to continue therapy. It can be pulled out if needed or left in
place similar to common heart pacemaker leads. The distal section
of the coronary vein 104 is filled with clot and/or bioglue and
will not bleed into the pericardial space.
[0028] FIG. 3 illustrates a more complex double balloon embodiment
of the catheter distal section. The double balloon provides a high
degree of isolation of the segment of the vein 107 where the
puncture 104 is made to contain bleeding. In addition the dumbbell
shape of the bubble space facilitates directing the access device
109 into the pericardial space. Lumen 115 can be used to infuse
fluid into the isolated segment of the coronary vein and to
aspirate fluid and blood if necessary.
[0029] FIG. 4 is a side view of catheter 102 in the coronary vein
103, and shows a view orthogonal to the view plane of FIGS. 2A to
F. The access device 109 exits the guiding catheter 102 sideways
using a side opening in the catheter shaft. This exit direction
facilitates directing and positioning of the access device 109.
[0030] The invention has been described in connection with the best
mode now known to the applicant inventors. The invention is not to
be limited to the disclosed embodiment. Rather, the invention
covers all of various modifications and equivalent arrangements
included within the spirit and scope of the appended claims. Common
to all the embodiments is that access is gained into the
pericardial space of a patient by puncturing and then sealing a
branch of a cardiac vein.
* * * * *