U.S. patent application number 11/111466 was filed with the patent office on 2005-12-08 for anatomical space access tools and methods.
This patent application is currently assigned to Medtronic, Inc.. Invention is credited to Bonner, Matthew D., Lokhoff, Nicolaas, Michels, Koen.
Application Number | 20050273129 11/111466 |
Document ID | / |
Family ID | 32174964 |
Filed Date | 2005-12-08 |
United States Patent
Application |
20050273129 |
Kind Code |
A1 |
Michels, Koen ; et
al. |
December 8, 2005 |
Anatomical space access tools and methods
Abstract
Medical devices and methods for accessing an anatomical space of
the body and particularly for penetrating the epicardium to access
pericardial space and the epicardial surface of the heart in a
minimally invasive manner employing suction are disclosed. The
distal end of a tubular access sleeve having a sleeve wall
surrounding a sleeve access lumen and extending between a sleeve
proximal end and a sleeve distal end having a plurality of suction
ports arrayed around the sleeve access lumen distal end opening is
applied against an outer tissue layer. Suction is applied through
the plurality of suction ports to a plurality of portions of the
outer tissue layer. A perforation instrument is introduced through
the sleeve access lumen to perforate the outer tissue layer to form
an access perforation into the anatomic space while the applied
suction stabilizes the outer tissue layer, whereby further
treatment drugs and devices can be introduced into the anatomic
space.
Inventors: |
Michels, Koen; (Maastricht,
NL) ; Lokhoff, Nicolaas; (Kerkrade, NL) ;
Bonner, Matthew D.; (Plymouth, MN) |
Correspondence
Address: |
Jeffrey J. Hohenshell
Medtronic, Inc.
7601 Northland Drive
Minneapolis
MN
55428
US
|
Assignee: |
Medtronic, Inc.
|
Family ID: |
32174964 |
Appl. No.: |
11/111466 |
Filed: |
April 21, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11111466 |
Apr 21, 2005 |
|
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10284771 |
Oct 31, 2002 |
|
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6890295 |
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Current U.S.
Class: |
606/185 |
Current CPC
Class: |
A61B 2017/306 20130101;
A61B 2017/3488 20130101; A61B 2017/00247 20130101; A61B 2018/00392
20130101; A61B 2017/3486 20130101; A61B 2017/00561 20130101; A61B
17/3415 20130101; A61B 17/3423 20130101 |
Class at
Publication: |
606/185 |
International
Class: |
A61B 017/34 |
Claims
1-33. (canceled)
34. A method of performing a medical procedure comprising: applying
suction through a plurality of suction ports to grasp the surface
of a tissue layer surrounding an anatomic space, the plurality of
suction ports being positioned at the distal end of a tubular
device and arrayed around a distal end opening of an access lumen
of the tubular device; introducing a penetration device through the
access lumen to the outer surface of the tissue layer; penetrating
the tissue layer to form a passage through the tissue layer and
into the anatomic space; withdrawing the penetration device from
the access lumen; and introducing a distal portion of a medical
device through the access lumen and the passage through the tissue
layer and into the anatomic space.
35. The method of claim 34 wherein the medical device is a
pacemaker lead.
36. The method of claim 34 wherein the medical device is a
defibrillator lead.
37. The method of claim 34 wherein the medical device comprises an
electrode.
38. The method of claim 34 wherein the medical device comprises a
needle.
39. The method of claim 34 wherein the medical device is a drug
delivery device.
40. The method of claim 34 wherein the medical device is a fluid
delivery device.
41. The method of claim 34 wherein the medical device is a fluid
removal device.
42. The method of claim 34 wherein the medical device is a cardiac
assist device.
43. The method of claim 34 wherein the medical device is a
catheter.
44. The method of claim 34 wherein the medical device is a
guidewire.
45. The method of claim 34 wherein the medical device is a
transmyocardial revascularization device.
46. The method of claim 34 wherein the medical device is a left
atrial appendage closure device.
47. The method of claim 34 wherein the medical device is an
ablation device.
48. The method of claim 34 wherein the medical device is a
scope.
49. The method of claim 34 wherein the medical device is a
dilator.
50. The method of claim 34 wherein the medical device is a
retraction device.
51. The method of claim 34 wherein the perforation device comprises
a knife.
52. The method of claim 34 wherein the penetration device comprises
a needle.
53. The method of claim 34 wherein the penetration device comprises
a stiff guidewire tip.
54. The method of claim 34 wherein the penetration device is an
electrosurgical cutting device.
55. The method of claim 34 wherein penetration device is a cutting
device.
56. The method of claim 34 wherein penetration device is a piercing
device.
57. The method of claim 34 wherein penetration device is a trocar
device.
Description
FIELD OF THE INVENTION
[0001] The present invention pertains to medical devices and
methods for accessing an anatomical space of the body and
particularly for entering the epicardium to access pericardial
space and the epicardial surface of the heart in a minimally
invasive manner.
BACKGROUND OF THE INVENTION
[0002] The human heart wall consists of an inner layer of simple
squamous epithelium, referred to as the endocardium, overlying a
variably thick heart muscle or myocardium and is enveloped within a
multi-layer tissue structure referred to as the pericardium. The
innermost layer of the pericardium, referred to as the visceral
pericardium or epicardium, clothes the myocardium. The epicardium
reflects outward at the origin of the aortic arch to form an outer
tissue layer, referred to as the parietal pericardium, which is
spaced from and forms an enclosed sac extending around the visceral
pericardium of the ventricles and atria. An outermost layer of the
pericardium, referred to as the fibrous pericardium, attaches the
parietal pericardium to the sternum, the great vessels and the
diaphragm so that the heart is confined within the middle
mediastinum. Normally, the visceral pericardium and parietal
pericardium lie in close contact with each other and are separated
only by a thin layer of a serous pericardial fluid that enables
friction free movement of the heart within the sac. The space
(really more of a potential space) between the visceral and
parietal pericardia is referred to as the pericardial space. In
common parlance, the visceral pericardium is usually referred to as
the epicardium, and epicardium will be used hereafter. Similarly,
the parietal pericardium is usually referred to as the pericardium,
pericardium will be used hereafter in reference to parietal
pericardium.
[0003] It is frequently medically necessary to access the
pericardial space to treat an injury, infection, disease or defect
of the heart, e.g., an occluded coronary artery, a defective heart
valve, aberrant electrical pathways causing tachyarrhythmias,
bacterial infections, to provide cardiac resynchronization therapy,
or to place epicardial pacing or cardioversion/defibrillation
electrodes against the epicardium or into the myocardium at
selected sites. It is necessary in these procedures to surgically
expose and cut through the pericardium to obtain access to the
pericardial space.
[0004] Highly invasive surgical techniques, referred to as a median
sternotomy (open-chest surgical exposure) or a thoracotomy, have
been typically employed to provide the surgeon access to the
pericardial space and the heart. A median sternotomy incision
begins just below the sternal notch and extends slightly below the
xyphoid process. A sternal retractor is used to separate the
sternal edges for optimal exposure of the heart. Hemostasis of the
sternal edges is typically obtained using electrocautery with a
ball-tip electrode and a thin layer of bone wax.
[0005] The open chest procedure involves making a 20 to 25 cm
incision in the chest of the patient, severing the sternum and
cutting and peeling back various layers of tissue in order to give
access to the heart and arterial sources. As a result, these
operations typically require large numbers of sutures or staples to
close the incision and 5 to 10 wire hooks to keep the severed
sternum together. Such surgery often carries additional
complications such as instability of the sternum, post-operative
bleeding, and mediastinal infection. The thoracic muscle and ribs
are also severely traumatized, and the healing process results in
an unattractive scar. Post-operatively, most patients endure
significant pain and must forego work or strenuous activity for a
long recovery period.
[0006] Many minimally invasive surgical techniques and devices have
been introduced In order to reduce the risk of morbidity, expense,
trauma, patient mortality, infection, and other complications
associated with open-chest cardiac surgery. Less traumatic limited
open chest techniques using an abdominal (sub-xyphoid) approach or,
alternatively, a "Chamberlain" incision (an approximately 8 cm
incision at the sternocostal junction), have been developed to
lessen the operating area and the associated complications. In
recent years, a growing number of surgeons have begun performing
coronary artery bypass graft (CABG) procedures using minimally
invasive direct coronary artery bypass grafting (MIDCAB) surgical
techniques and devices. Using the MIDCAB method, the heart
typically is accessed through a mini-thoracotomy (i.e., a 6 to 8 cm
incision in the patient's chest) that avoids the sternal splitting
incision of conventional cardiac surgery. A MIDCAB technique for
performing a CABG procedure is described in U.S. Pat. No.
5,875,782, for example.
[0007] Other minimally invasive, percutaneous, coronary surgical
procedures have been advanced that employ multiple small
trans-thoracic incisions to and through the pericardium,
instruments advanced through ports inserted in the incisions, and a
thoracoscope to view the accessed cardiac site while the procedure
is performed as shown, for example, in U.S. Pat. Nos. 6,332,468,
5,464,447, and 5,716,392. Surgical trocars having a diameter of
about 3 mm to 15 mm are fitted into lumens of tubular trocar
sleeves, cannulae or ports, and the assemblies are inserted into
skin incisions. The trocar tip is advanced to puncture the abdomen
or chest to reach the pericardium, and the trocar is then withdrawn
leaving the sleeve or port in place. Surgical instruments and other
devices such as fiber optic thoracoscopes can be inserted into the
body cavity through the sleeve or port lumens. As stated in the
'468 patent, instruments advanced through trocars can include
electrosurgical tools, graspers, forceps, scalpels,
electrocauteries, clip appliers, scissors, etc.
[0008] In such procedures, the surgeon can stop the heart by
utilizing a series of internal catheters to stop blood flow through
the aorta and to administer cardioplegia solution. The endoscopic
approach utilizes groin cannulation to establish cardio-pulmonary
bypass (CPB) and an intraaortic balloon catheter that functions as
an internal aortic clamp by means of an expandable balloon at its
distal end used to occlude blood flow in the ascending aorta. A
full description of an example of one preferred endoscopic
technique is found in U.S. Pat. No. 5,452,733, for example.
[0009] However, recently developed, beating heart procedures
eliminate the need for any form of CPB, the extensive surgical
procedures necessary to connect the patient to a CPB machine, and
to stop the heart. These beating heart procedures can be performed
on a heart exposed in a full or limited thoracotomy or accessed
percutaneously.
[0010] In such percutaneous procedures, the epicardium of the
beating or stopped heart is exposed to view typically by use of
grasping and cutting instruments inserted through one port to cut
through the pericardium surrounding the heart while the area is
viewed through the thoracoscope or endoscope inserted through
another port. The thoracoscopic approach typically requires the
placement of a chest tube and admission to the hospital for the
initial 1-2 post-operative days.
[0011] Therefore, much effort has been expended to develop medical
devices and techniques to access the pericardial space employing
such minimally invasive percutaneous procedures. One difficulty has
been that normally the pericardial space is so small or thin that
it is difficult to penetrate the pericardium using miniaturized
instruments capable of being introduced through a port to the site
without also puncturing the underling epicardium and thereby,
damaging the myocardium or a coronary vessel. Proliferative
adhesions occur between the pericardium and the epicardium in
diseased hearts and hamper access to the pericardial space
employing such minimally invasive percutaneous procedures. The
simple percutaneous approach can be used to penetrate the
pericardium to drain a large pericardial effusion, i.e., an
accumulation of too much fluid in the pericardial space that widens
the pericardial space. A spinal needle (18-20 gauge) and stylet
occluding the needle lumen are advanced incrementally in a
superior/posterior fashion through a small (2-4 mm) cutaneous
incision between the xyphoid and costal cartilage. Periodically,
the stylet is removed, and fluid aspiration is attempted through
the needle lumen. The advancement is halted when fluid is
successfully aspirated, and the pericardial effusion is then
relieved.
[0012] Methods and apparatus for accessing the pericardial space
for the insertion of implantable defibrillation leads are disclosed
in U.S. Pat. Nos. 5,071,428 and 6,156,009, wherein a forceps device
is used to grip the pericardium and pull it outward to form a
"tent". In the '428 patent, a scissors or scalpel is introduced to
cut the pericardium (pericardiotomy) under direct vision through a
sub-xyphoid surgical incision. The forceps device disclosed in the
'009 patent incorporates a mechanism for introducing electrical
leads or guidewires through the outwardly displaced pericardium. It
is difficult to introduce and use the forceps through the narrow
lumen of a port or sleeve, particularly if the pericardial fluid is
under pressure that makes the pericardium taut like an inflated
balloon.
[0013] Further methods and apparatus for accessing the pericardial
space for the insertion of devices or drugs are disclosed in U.S.
Pat. No. 6,423,051, wherein an access tube having a device access
lumen is provided with a plurality of hooks in the tube distal end
that can be used to hook into the pericardium to enable the lifting
and "tenting" of the pericardium. A cuffing instrument or sharpened
tip guidewire or the like can be advanced through the device access
lumen to perforate the pericardium.
[0014] Other methods and apparatus that are introduced through
percutaneously placed ports or directly through small
trans-thoracic incisions for accessing the pericardial space employ
suction devices to grip the epicardium as disclosed, for example,
in U.S. Pat. Nos. 4,991,578, 5,336,252, 5,827,216, 5,868,770,
5,972,013, 6,080,175, and 6,231,518. The suction device is
configured like a catheter or tube having a single suction lumen
and typically having a further instrument delivery lumen. The
suction lumen terminates in a single suction lumen end opening
through the device distal end in the '578, '252, '175, '770, and
'013 patents and through the device sidewall in the '216 and '518
patents. Certain of these patents recite that the applied suction
draws a "bleb," i.e., a locally expanded region of the pericardium,
into the suction lumen or a suction chamber at the device distal
end. A needle can then be advanced into the bleb and used to draw
off fluids or deliver drugs into the pericardial space, or the
like. In addition, it is suggested in these patents that treatment
devices including catheters, guidewires, and electrodes, e.g.,
defibrillation electrodes, can be advanced into the pericardial
space through a device introduction lumen for a variety of reasons.
Although theoretically plausible, the ability to reliably maintain
a vacuum seal against the pericardium when such treatment devices
are advanced can be problematic.
[0015] For these reasons, it would be desirable to provide
additional and improved methods and apparatus for the minimally
invasive access to a patient's pericardial space. The methods and
devices should be suitable for a wide variety of minimally invasive
approaches to the pericardium, including at least
intercostal/transthoracic and subxiphoid approaches, and the like.
The methods and devices should further provide for secure and
stable capture of the pericardium and permit the opening of a large
space or volume between the pericardium and epicardium. Such access
methods and apparatus should be useful for a wide variety of
procedures to be performed in the pericardial space, including
fluid withdrawal, drug delivery, diagnostic and therapeutic
electrophysiology procedures, pacemaker lead implantation,
defibrillator lead placement, transmyocardial revascularization,
transmyocardial revascularization with drug delivery, placement of
the left ventricular assist devices, placement of the arterial
bypass graphs, in situ bypass, i.e., coronary artery-venous
fistulae, placement of drug delivery depots, closure of the left
arterial appendage, and the like. At least some of these objectives
will be met by the invention described herein.
SUMMARY OF THE INVENTION
[0016] The present invention provides methods, apparatus, and kits
for accessing an anatomic space between an inner tissue layer and
an outer tissue layer. The phrase "anatomic space" is meant to
include any natural, potential, or created space or cavity within a
patient's body where it may be desirable to gain access for
surgical, diagnostic, therapeutic, lead delivery, visualization, or
any other purpose. The inner tissue layer may consist of a
membrane, a capsule or the adventia, muscularis and endothelial
layers of a hollow organ or vessel. The methods, apparatus, and
kits are particularly useful for minimally invasive access
procedures, but could also be used for accessing internal anatomic
spaces where initial access to the outer tissue layer is achieved
via open surgical procedures. The present invention will be
particularly useful for accessing a patient's pericardial space
between the epicardium and pericardium for performing a wide
variety of procedures, generally as set forth above. Other internal
organs that may be accessed include the intestines, fallopian
tubes, gall bladder, kidneys, and the like.
[0017] Apparatus and methods according to the present invention for
accessing an anatomic space between an accessible outer tissue
layer and an inner tissue layer utilize suction applied to the
outer tissue layer through a plurality of relatively small suction
ports at the distal end of a tubular access sleeve, e.g., a trocar
sleeve, applied against the outer tissue layer. The plurality of
suction ports are formed in the distal end surface of the wall of
the tubular access sleeve and are either flush with the end surface
or extend slightly distal to the end surface. The suction ports are
arrayed around the sleeve wall distal end and substantially
surround a device access lumen of the sleeve. Each of the plurality
of suction ports in the sleeve distal end communicates with a
suction manifold through a plurality of suction lumens in the
sleeve wall. The suction manifold can be coupled to a vacuum
source. Alternatively, each suction lumen or groups of suction
lumens can be coupled separately to a vacuum source through
individual valves, so that the loss of suction at any given suction
port does not affect the suction applied at other suction ports.
The applied suction stabilizes a ring of the outer tissue layer, so
that the outer tissue layer can be lifted away from the wall to
increase the anatomic space by lifting the proximal end of the
sleeve.
[0018] The plurality of suction ports arrayed around the sleeve
distal end provide more robust fixation to the outer tissue layer
than a single large area suction port due to their redundancy. At
least some of the plurality of suction ports readily engage the
tissue surface under low suction force to enable lifting of the
outer tissue layer. Engagement of tissue surface areas by all of
the suction ports is not necessary. Similarly, the loss of
engagement of some of suction ports with the tissue surface areas
does not result in complete loss of engagement as is the case when
an edge of a single large suction port releases from the tissue
surface of the outer tissue layer.
[0019] A perforation device, e.g., a knife, a needle, a stiff
guidewire tip, an electrosurgical cutting tool or other piercing or
cutting instrument, can then be introduced through the sleeve
access lumen to perforate the outer tissue layer and form an access
hole or perforation there through creating access into the anatomic
space while the access tube stabilizes the outer tissue layer.
Advantageously, there is no suction applied through the sleeve
access lumen that is necessary to maintain the attachment to the
outer tissue layer while it is being perforated or other
instruments are advanced through the perforation. The fixation of
the outer tissue layer is not lost when the outer tissue layer is
perforated. Moreover, it is simpler to advance instruments through
the sleeve access lumen from a proximal lumen end opening that is
exposed to the atmosphere.
[0020] In a further aspect of the present invention, a retention
mechanism is inserted through the sleeve access lumen and the
created access hole through the outer issue layer and deployed in
the anatomic space to inhibit retraction of the sleeve distal end
from contact against the outer surface of the outer tissue layer.
Additionally, the retention mechanism can be incorporated into an
access device or catheter inserted into the anatomic space and
deployed to bear against the inner surface of the outer tissue
layer.
[0021] The methods, apparatus and kits of the present invention can
advantageously be used to access the pericardial space between the
pericardium and epicardium. In a still further aspect of the
present invention, various devices are introduced into the
pericardial space for temporary treatment of the heart or
pericardial space or to complete a surgical procedure or for
permanent implantation against the epicardium or within the
pericardial space or within the myocardium or within a coronary
vein or artery.
[0022] The tubular access sleeve can be circular or oval or have
any other desirable cross-section shape. The tubular access sleeve
can be straight, curved for formed with a bend or formed of a
bendable material to be shaped by the user.
[0023] This summary of the invention has been presented here simply
to point out some of the ways that the invention overcomes
difficulties presented in the prior art and to distinguish the
invention from the prior art and is not intended to operate in any
manner as a limitation on the interpretation of claims that are
presented initially in the patent application and that are
ultimately granted.
BRIEF DESCRIPTION OF THE DRAWINGS
[0024] These and other advantages and features of the present
invention will be more readily understood from the following
detailed description of the preferred embodiments thereof, when
considered in conjunction with the drawings, in which like
reference numerals indicate identical structures throughout the
several views, and wherein:
[0025] FIG. 1 is an illustration of the preparation of a patient
for accessing the pericardial space through the use of a trocar
sleeve of the present invention;
[0026] FIG. 2 is a perspective view of a trocar sleeve of the
present invention associated with a trocar puncture rod that fits
into the trocar sleeve lumen to form a trocar for making a
percutaneous incision;
[0027] FIG. 3 is an expanded end view of the trocar sleeve distal
end depicting a plurality of suction ports in the trocar sleeve
distal end that are in communication with trocar sleeve lumens in
the sleeve wall; FIG. 4 is an expanded partial side view in partial
cross-section of the trocar sleeve wall exposing suction ports in
the trocar sleeve distal end in communication with trocar sleeve
lumens in the sleeve wall;
[0028] FIG. 5 is an expanded partial side view in partial
cross-section of the trocar sleeve wall exposing suction ports in
the trocar sleeve distal end in communication with trocar sleeve
lumens in the sleeve wall wherein the suction ports extend distally
from the trocar sleeve distal end to facilitate adherence to the
pericardium;
[0029] FIG. 6 is a schematic illustration of the advancement of the
trocar sleeve distal end into contact with the epicardium of the
heart of FIG. 1;
[0030] FIG. 7 is a schematic illustration of the application of
suction from the plurality of suction ports to the epicardium
enabling lifting of the epicardium to expand the pericardial
space;
[0031] FIG. 8 is a schematic illustration the insertion of a
cutting instrument through the sleeve access lumen to perforate the
pericardium during the application of suction from the plurality of
suction ports to the epicardium enabling lifting of the epicardium
to expand the pericardial space;
[0032] FIG. 9 is an illustration of the insertion of a cardiac
pacing lead through the sleeve access lumen into the pericardial
space during the application of suction from the plurality of
suction ports to the epicardium enabling lifting of the epicardium
to expand the pericardial space;
[0033] FIG. 10 is a schematic illustration of the insertion of a
further medical device through the sleeve access lumen into the
pericardial space and laterally along the epicardium to a selected
lateral site or the pericardial space during the application of
suction from the plurality of suction ports to the epicardium
enabling lifting of the epicardium to expand the pericardial
space;
[0034] FIG. 11 is a schematic illustration of the insertion of a
deflectable tip endoscope and light source for visualizing the
pericardial space laterally having an integral endoscope lumen
through which a medical device is advanced into the pericardial
space during the application of suction from the plurality of
suction ports to the epicardium enabling lifting of the epicardium
to expand the pericardial space; and
[0035] FIG. 12 is a schematic illustration of the insertion of a
retractor, particularly a balloon catheter, through the sleeve
access lumen into the expanded pericardial space to reinforce the
suction force, and the insertion of a medical device through a
precurved introducer.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0036] In the following detailed description, references are made
to illustrative embodiments of methods and apparatus for carrying
out the invention. It is understood that other embodiments can be
utilized without departing from the scope of the invention.
Preferred methods and apparatus are described for accessing the
pericardial space between the epicardium and the pericardium as an
example of accessing an anatomic space between an inner tissue
layer and an outer tissue layer, respectively.
[0037] The access to the pericardial space in accordance with the
present invention facilitates the performance of a number of
ancillary procedures. For example, the procedures include
introducing and locating the distal end of a catheter or guidewire
or an electrode of a cardiac ablation catheter or a pacing lead or
a cardioversion/defibrillation lead within the pericardial space
and attached to the epicardium or myocardium. Other possible
procedures include performing a coronary artery anastomosis in a
thoracoscopic CABG procedure, replacing a defective heart valve,
ablating aberrant electrical pathways in the atria to alleviate
atrial tachyarrhythmias, introducing drugs or anti-bacterial agents
into the pericardial space, relieving pericardial fluid pressure or
providing cardiac resynchronization therapy.
[0038] The preferred embodiments of the present invention are
incorporated into instruments referred to as "trocars" that are
usually used to penetrate or be driven through tissue to form a
wound or passage to an internal body organ or other structure. Such
trocars are therefore elongated, tubular, and axially stiff and
have a tissue penetrating distal end. Certain trocars are simply
one-piece rods of a prescribed diameter and length that are
advanced through tissue to form a passage and then removed so that
other instruments can be advanced through the passage.
[0039] Other trocars comprise a tubular outer sleeve, sometimes
referred to as a port or cannula or at times as the trocar itself,
having a sleeve access lumen extending between lumen end openings
at the sleeve proximal end and sleeve distal end, and an inner
puncture core or rod that fits within the sleeve access lumen. The
inner puncture rod typically has a tissue penetrating distal end
that extends distally from the sleeve distal end when the inner
puncture rod is fitted into the sleeve access lumen for use. The
two-piece assembled trocar can be advanced as a unit through body
tissue, and the inner puncture rod then removed leaving the trocar
sleeve in place to maintain a fixed diameter passage through the
tissue for use by other instruments.
[0040] For example, FIG. 1 illustrates the placement of instruments
for observation and accessing the pericardial space through an
incision in the pericardium 24 exposing the heart 30 to perform any
of the ancillary procedures listed above. The patient 12 is placed
under general anesthesia, and the patient's left lung is deflated
if necessary, using conventional techniques. The patient 12 is
placed in a lateral decubitus position on his right side, and
multiple small percutaneous incisions are to be made in the chest
wall for the receipt of surgical instruments. As used herein, the
term "percutaneous" refers to any penetration through the skin of
the patient, whether in the form of a small cut, incision, hole,
cannula, trocar sleeve or port or the like, that is preferably made
in an interstitial space between the ribs of the patient.
[0041] A trocar sleeve 14 is shown left in place in a first passage
10 that is made as described above in the chest wall of a patient
12 between the patient's 2nd rib and 6th rib, for example. The
selection of the exact location of the first passage 10 is
dependent upon a patient's particular anatomy.
[0042] Typically, the patient's left lung is deflated by
instruments advanced through the lumen of one of the trocar sleeves
to allow unobstructed observation of the pericardium 24 employing a
thoracoscope 16 inserted through the lumen of trocar sleeve 14. The
deflation is accomplished by drawing a vacuum through a lung tube
(not shown) that is inserted through the mouth or nose of the
patient 12 into the left lung of the patient 12. After deflation,
the peritoneal cavity is suffused with a gas, e.g., carbon
monoxide, to pressurize the cavity to keep it open and sterile. The
pressurized gas keeps the deflated lung away from the left heart so
that the left heart can be viewed and accessed and provides a
working space for the manipulation of the tools of the present
invention.
[0043] The thoracoscope 16 is then inserted into the lumen of the
trocar sleeve 14 to permit observation by a surgeon directly
through an eyepiece 18 or indirectly through incorporation of a
miniaturized image capture device, e.g., a digital camera, at the
distal end of the thoracoscope 16 or optically coupled to the
eyepiece 18 that is in turn coupled to an external video monitor
(not shown). The thoracoscope 16 also incorporates a light source
for illuminating the cavity with visible light so that the
epicardial surface can be seen directly or indirectly. The depicted
thoracoscope 16 is used to directly visualize the thoracic cavity
and obtain a left lateral view of the pericardial sac or
pericardium over the heart 30.
[0044] A two-piece trocar 22 of an embodiment of the present
invention depicted in FIG. 2 is employed to make a second
passageway 20 that is intercostal, i.e., between the ribs in this
illustration, and the second trocar sleeve 34 is left in place as
shown in FIG. 1. The second passageway 20 can be made in other
locations in order to more readily access more cephalad and/or
posterior sites of the left heart. The two-piece trocar 22 can be
inserted in a sub-xyphoid approach or any other suitable approach
through the chest wall, and the second trocar sleeve 34 left in
place. A third passageway may be made using a further trocar for
additional instrumentation or thoracoscopic observation or infusion
of sterilizing gas as well as later placement of a chest drainage
tube. Often, it will be advantageous to insert a fourth two-piece
trocar for introducing a clipping or suturing device into the
thoracic cavity through the lumen of the fourth trocar sleeve. In
each case, the trocar rods are removed leaving the trocar sleeves
in place.
[0045] The trocar 22 comprises the tubular outer trocar sleeve 34
and the puncture rod 54 that fits within the sleeve access lumen
36. The sleeve access lumen 36 is axially aligned with the
elongated axis of the outer trocar sleeve 34 and extends between
lumen end openings at the sleeve proximal end 38 and sleeve distal
end 40. The puncture rod 54 extends between a proximal stop 58 and
a tissue penetrating distal end 56 that extends distally from the
sleeve distal end 40 when the puncture rod 54 is fitted into the
sleeve access lumen 36 for use in making passageway 20. The
two-piece assembled trocar 22 can be advanced as a unit through the
chest wall between the ribs, and the puncture rod 54 can then
removed leaving the trocar sleeve 34 in place to maintain a fixed
diameter passage 20 through the chest wall for use by other
instruments. The advancement of the trocar 22 as an assembly is
carefully observed to ensure that the tissue penetrating distal end
56 is not advanced all of the way into contact with the pericardium
24.
[0046] In accordance with the present invention, the trocar sleeve
34 can then be advanced further into the passageway 20 to dispose
the sleeve distal end 40 against the pericardium. The trocar sleeve
34 is configured to apply suction from a vacuum source, which can
be a hospital operating room vacuum line or a simple hand operated
vacuum pump or syringe, against the pericardium to grip and tent a
portion of the pericardium 24 outward as the trocar sleeve is
retracted proximally. The tenting is visualized by the surgeon
through the thoracoscope 16. The parietal pleura is dissected and
the pericardial sac is opened by instrument 32 introduced through
the lumen of the second trocar sleeve 34.
[0047] The application of suction is accomplished through the
incorporation of a plurality N of suction ports, e.g., twelve
suction ports 42.sub.1- 42.sub.12, at the sleeve distal end 40 as
shown in FIGS. 3 and 4. The suction ports 42.sub.1- 42.sub.12 at
the sleeve distal end 40 communicate with a suction manifold 48
through at least one or a respective plurality of suction lumens,
e.g., a like number of suction lumens 46.sub.1- 46.sub.12, in the
sleeve wall 44. The suction lumens 46.sub.1-46.sub.12 can extend
the full distance between the suction manifold 48 and the suction
ports 42.sub.1-42.sub.12. Or the suction lumens 46.sub.1-46.sub.12
can be joined together into a single lumen or combined into a
lesser number of suction lumens at any point within or alongside
the sleeve wall between the sleeve distal end 40 and the suction
manifold 48. The manifold 48 can simply comprise an interior lumen
within the sleeve wall or an enlargement of the sleeve wall that is
coupled to the plurality of suction lumens 46.sub.1-46.sub.12.
[0048] The suction ports 42.sub.1-42.sub.12 are arrayed around the
sleeve distal end 40 and substantially surround the sleeve access
lumen 36 that is employed for device access into the pericardial
space. A side port 50 extends laterally from the manifold 48 and
has a standardized coupler for attachment with a vacuum source. It
is expected that a relatively low suction provided by a pump or a
manually operated syringe will suffice to enable lifting of the
pericardium to expand the pericardial space beneath the sleeve
distal end 40.
[0049] The trocar 22 is depicted as having a circular
cross-section, but it will be understood that the trocar 22 can
have a non-circular cross-section, e.g., an oval cross-section like
the oval-shaped cardiac cannula disclosed in commonly assigned U.S.
Pat. No. 6,146,371. Such an oval cross-section provides a minimum
diameter enabling ready insertion between the patient's ribs and a
maximum diameter that enlarges the area of the sleeve access lumen
36.
[0050] A distal section of the trocar sleeve wall 44 can be formed
of a softer material than the proximal section of the sleeve wall
44 to prove a sleeve distal end 40 that can conform somewhat to the
shape of the pericardium at a given site.
[0051] The sleeve distal end 40 can be at right angles to the axis
of the sleeve wall 44 as depicted in FIG. 4. Or the sleeve distal
end can be at a bevel or angle to the sleeve wall axis as shown,
for example, by sleeve distal end 40' in FIG. 11 to facilitate the
orientation of the sleeve distal end 40' to the pericardium when
inserted between the ribs or in a sub-xyphoid approach toward the
heart.
[0052] The number N of suction ports 42 can be selected as a
function of the diameter of the sleeve 34 and the thickness of the
sleeve wall 44 to optimize the function of lifting the pericardium
around the sleeve access lumen 36. For example, it has been found
that the number N of suction lumens 42 can number between 6 and
12.
[0053] Moreover, as illustrated in FIG. 5, it has been found
desirable to extend the suction ports distally of the sleeve distal
end 40 a few millimeters so as to facilitate drawing portions of
the pericardium into the distal suction ports 42.sub.1-42.sub.8 of
the suction lumens 46.sub.1-46.sub.8.
[0054] It will also be understood that a plurality of instruments
can be introduced at the same time through the sleeve access lumen
36. In particular, a guidewire can be first advanced through the
sleeve access lumen and into the pericardial space, and a further
dilator, catheter, medical electrical lead, or other instrument can
be introduced over the guidewire. The catheter can have a preformed
curved tip or a deflectable tip so that the catheter distal end can
be directed laterally within the pericardial space to enable
lateral deployment of a wire or medical electrical lead or other
instrument through the catheter lumen.
[0055] In addition, it may be desirable to insert a miniaturized,
flexible, illumination and visualization endoscope through the
sleeve access lumen 36 into the pericardial space to visually
examine the pericardial space and track advancement or use of a
catheter, medical electrical lead, or other instrument within the
pericardial space.
[0056] As illustrated in FIGS. 5-7, the applied suction (S)
stabilizes at least N discrete portions of a ring of the outer
tissue layer, i.e., the pericardium (P) in this exemplary
embodiment, so that the outer tissue layer can be lifted away from
the inner tissue layer, i.e., the epicardium (EP), by retracting or
lifting the trocar sleeve proximal end 38 to increase the anatomic
space, i.e., the pericardial space (PS). The increased pericardial
space PS' is created by lifting the sleeve distal end 40 while the
suction S grips the outer accessible surface of the pericardium as
shown in FIG. 7. Then, a cutting or perforation instrument 32,
e.g., a knife, scissors, a needle, a stiff guidewire tip, an
electrosurgical cutting tool or other piercing instrument shown
schematically in FIG. 8, can be introduced through the sleeve
access lumen 36. The perforation instrument 32 is then used to
perforate the pericardium P and form an access perforation (AP)
therethrough of a sufficient size to enable access into the
pericardial space PS' while the applied suction S continues to hold
the pericardium P and enable enlargement of the pericardial space
PS'.
[0057] FIG. 9 is an illustration of the insertion of a cardiac
pacing lead 60 through the sleeve access lumen 36 into the expanded
pericardial space PS' during the application of suction S from the
plurality of suction ports 42 to the epicardium EP enabling lifting
of the epicardium EP to expand the pericardial space PS'. The
cardiac pacing lead 60 can take any configuration, but the depicted
configuration is a small diameter, straight conductor, highly
flexible, screw-in epicardial lead having a fixation helix
extending in axial alignment with the lead body axis similar to
that depicted in commonly assigned U.S. Pat. No. 5,246,014, for
example. It should be appreciated that the small diameter and high
flexibility of the lead 60 render it too pliable for implantation
without stiffening or confinement in an introducer. The lead 60 is
therefore assembled into a system including an introducer 62 that
fits over the lead body and a catheter 64 that fits over introducer
62 and lead 60. The inner diameter of the sleeve access lumen 36 is
sufficiently large to receive the outer diameter of the catheter 64
when the assembly is inserted through it. The lead 60 terminates in
a distal, electrically uninsulated, helical, screw-in electrode 66
electrically connected to the conductor of lead 60. It is expected
that the assembly can be advanced laterally along the myocardium
with minimal expansion of the pericardial space PS'.
[0058] As further illustrated in FIG. 9, the distal end 68 of the
introducer 62 is shaped to engage the shank 67 of the helical
screw-in electrode 66 so that it can be rotated by rotation of the
proximal end of introducer 62 to screw the helical screw-in
electrode 66 through the epicardium EP and into the myocardium
(MC). In use, the trocar sleeve 34 is positioned as described above
with respect to FIGS. 5-8 so that the applied suction S and lift L
forms the expanded pericardial space PS'. The lead system is
assembled by sliding the introducer 62 over the lead body until the
distal end 68 of the introducer 62 firmly engages the screw-in
electrode 66. Although it is depicted in FIG. 9, the outer catheter
64 may or may not be employed since the sleeve access lumen
confines the introducer 62 and screw-in lead 60. The assembled lead
system is inserted through the sleeve access lumen 36 so that the
distal end 68 of the introducer 62 and screw-in electrode 66 are
disposed through the access perforation AP and within the expanded
pericardial space PS'. Rotational torque is imparted to the
proximal end of the introducer 62 to screw the helical screw-in
electrode 66 through the epicardium EP and into the myocardium
(MC). Then, the introducer 62 is retracted from the sleeve access
lumen 36.
[0059] Pacing and sensing threshold tests are conducted in the
conventional manner to determine that the implantation site is
suitable. If the thresholds are acceptable, the suction S is then
discontinued, and the trocar sleeve 34 can be removed from the
incision 20 of FIG. 1. The lead body and proximal connector of the
lead 60 can then be routed subcutaneously in a conventional manner
to the site of implantation of an to complete the implantation of
the cardiac pacemaker in the patient's body.
[0060] FIG. 10 schematically illustrates the insertion of a further
elongated medical device 70 comprising an instrument, catheter, or
medical electrical lead cardiac pacing lead, etc., through the
sleeve access lumen 36 into the expanded pericardial space PS' and
advancement of the instrument distal tip 72 laterally along the
epicardium EP to a selected lateral site of the expanded
pericardial space PS'. Suction S and lift L are applied as
described above to expand the pericardial space PS' during the
lateral advancement of the instrument distal tip 72.
[0061] The lateral advancement of the further elongated medical
device 70 is facilitated by inserting the trocar 22 through
incision 20 at an oblique angle to the pericardium P, which is
likely to be the case most of the time. The oblique approach can be
facilitated by providing an angled sleeve distal end 40' as shown
in FIG. 11 that is rotated in incision 20 until the angled sleeve
distal end 40' optimally engages against the outer surface of
pericardium P.
[0062] The lateral advancement of the further elongated medical
device 70 can also be facilitated by use of an introducer guide
wire or catheter having a deflectable distal tip or a curved distal
segment that is straightened when inserted into the sleeve access
lumen 36. The curve in the distal end or segment is restored when
the distal end or segment is advanced out of the distal end opening
of the sleeve access lumen 36 and into the expanded pericardial
space PS'.
[0063] FIG. 11 schematically illustrates the incorporation of these
features into an endoscope 80 advanced through the sleeve access
lumen 36 and having a deflectable distal segment 82 and an
introducer lumen through which the elongated medical device can be
introduced into the expanded pericardial space PS'. The endoscope
80 can incorporate any of the known deflectable tip control
mechanisms, an introducer lumen, a lamp or light pipe distal end 84
for illuminating the expanded pericardial space PS', and an image
capture device 86, e.g., a digital camera or a light pipe distal
end extending to an external image display. The external light
source comprises either a power supply or a lamp that is coupled
either through power conductors or a light pipe, respectively, 88
to the either the lamp or light pipe distal end, respectively, 84.
The external visual display is either coupled optically to the
light pipe or through a set of conductors 90 powering and receiving
data from the image capture device 86.
[0064] In use, the elongated medical device 70 is inserted into the
introducer lumen, the endoscope 80 is inserted into the sleeve
access lumen 36, and the right angle or angled trocar sleeve distal
end 40 or 40' is advanced and oriented against the pericardium P.
Suction S and lift L are applied as described above, and the
expanded pericardial space PS' is created.
[0065] The deflectable distal segment 82 of the endoscope 80 is
then advanced into the expanded pericardial space PS'. Light is
emitted into the expanded pericardial space PS' by lamp or light
pipe distal end 84, and the illuminated area is displayed via the
image capture device 86.
[0066] The distal segment 82 is preferably deflectable so that it
can be deflected to orient the introducer lumen distal end opening
laterally through movement of the push-pull wires at the endoscope
proximal end while observing the illuminated area of the expanded
pericardial space PS'. Once the desired orientation is achieved,
the distal end 72 of the elongated medical device 70 is advanced
laterally in the expanded pericardial space PS' and further in the
unexpanded pericardial space PS to a desired site.
[0067] It should be understood that certain of the features of the
endoscope 82 can be incorporated into the sleeve wall.
[0068] It may also be desirable to introduce a retention mechanism
into the expanded pericardial space PS' that reinforces the
attachment of the sleeve distal end 40 or 40' to the pericardium P
and inhibits retraction of the sleeve distal end 40 away from the
pericardium P. FIG. 12 is a schematic illustration of the insertion
of a retractor, particularly a balloon (or mechanical fixation)
catheter 100, through the sleeve access lumen 36 into the expanded
pericardial space PS' to reinforce the suction force. A precurved
introducer 110 is also illustrated introduced through the balloon
catheter lumen 102. The elongated medical device 70 is introduced
through the introducer lumen 112. It will be understood that the
precurved introducer 110 can be eliminated and that a retraction
mechanism can be employed with or incorporated into the endoscope
80 or lead delivery introducer 64. The balloon 104 is adapted to be
inflated to apply retraction force against the inner surface of the
pericardium P and press the pericardium P against the plurality of
suction ports illustrated in FIGS. 3-5 and described above. The
suction S can also be discontinued if the inflated balloon diameter
is sufficiently large to inhibit retraction of the balloon 104
through the access perforation AP. The balloon 104 is inflated and
deflated through an inflation/deflation lumen 106 in the sidewall
of the balloon catheter 100 in the conventional manner.
[0069] In use, the introducer distal segment 114 is straightened
and inserted into the balloon catheter lumen 102, and the
introducer 110 is advanced toward the balloon catheter distal end
108. The elongated medical device 70 is inserted into the proximal
end opening of the introducer lumen 112 and advanced to the
introducer distal end. The assembly of the balloon catheter 100,
the introducer 110, and the elongated medical device 70 is inserted
and advanced through the sleeve access lumen 36, and the right
angle or angled trocar sleeve distal end 40 or 40' is advanced and
oriented against the pericardium P.
[0070] The balloon 104 is then advanced into the expanded
pericardial space PS' and inflated as suction S and lift L are
applied as described above, and the expanded pericardial space PS'
is created. The curve in the introducer distal segment 114 is
restored as it is advanced out of the balloon catheter lumen 102.
The introducer 110 and elongated medical device 70 can be rotated
within the balloon catheter lumen 102 to aim the elongated medical
device in the desired direction. Then, the elongated medical device
distal end 72 is advanced out of the introducer lumen 112 and
laterally in the expanded pericardial space PS' and further in the
unexpanded pericardial space PS to a desired site.
[0071] Another retention mechanism that can be substituted for the
balloon 104 comprises expandable cages or fingers that can be
expanded outward and pulled back inward through use of push-pull
wires. Such an expandable cage retention mechanism is disclosed,
for example, in U.S. Pat. No. 5,402,772.
[0072] Or the retraction mechanism comprises flexible, pliant tines
formed of polyurethane or silicone rubber or shape memory alloy and
mounted near the catheter distal end to extend outward of the
catheter sidewall when located in the pericardial space PS'. Such
tines are adapted to readily fold inward during advancement of the
catheter distal end through the access perforation AP but resist
retraction back out through the access perforation AP unless the
catheter proximal end is retracted with sufficient force to fold
the tines inward. Suitable tine retention mechanisms are disclosed,
for example, in U.S. Pat. No. 5,300,107.
CONCLUSION
[0073] All patents and publications referenced herein are hereby
incorporated by reference in their entireties.
[0074] It will be understood that certain of the above-described
structures, functions and operations of the above-described
preferred embodiments are not necessary to practice the present
invention and are included in the description simply for
completeness of an exemplary embodiment or embodiments.
[0075] In addition, it will be understood that specifically
described structures, functions and operations set forth in the
above-referenced patents can be practiced in conjunction with the
present invention, but they are not essential to its practice. It
is therefore to be understood, that within the scope of the
appended claims, the invention may be practiced otherwise than as
specifically described without actually departing from the spirit
and scope of the present invention.
* * * * *