U.S. patent application number 10/785874 was filed with the patent office on 2005-05-05 for minimally invasive cardiac surgery procedure.
Invention is credited to Cosgrove, Delos M..
Application Number | 20050092333 10/785874 |
Document ID | / |
Family ID | 25181261 |
Filed Date | 2005-05-05 |
United States Patent
Application |
20050092333 |
Kind Code |
A1 |
Cosgrove, Delos M. |
May 5, 2005 |
Minimally invasive cardiac surgery procedure
Abstract
A minimally invasive approach for surgery on portions of the
heart and great vessels. A parasternal incision is made extending
across a predetermined number of costal cartilages, e.g., a right
parasternal incision extending from the lower edge of the second
costal cartilage to the superior edge of the fifth costal
cartilage. One or more costal cartilages, e.g., the third and
fourth, are then excised to provide access to the portion of the
heart or great vessels of interest, for example between a point
approximately three centimeters above supra annular ridge and the
mid ventricular cavity, and a desired procedure completed. A
minimally invasive procedure for repair or replacement of the
aortic valve is disclosed that includes making a transverse
incision of about 10 cm in length over the second or third
intercostal space in the thorax of the patient, dividing the
sternum transversely following the incision, retracting the
transversely divided sternum, exposing the ascending aorta, and
incising the ascending aorta to provide access to an area adjacent
the aortic valve.
Inventors: |
Cosgrove, Delos M.; (Hunting
Valley, OH) |
Correspondence
Address: |
EDWARDS LIFESCIENCES CORPORATION
ONE EDWARDS WAY
LEGAL DEPARTMENT
IRVINE
CA
92614
US
|
Family ID: |
25181261 |
Appl. No.: |
10/785874 |
Filed: |
February 23, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10785874 |
Feb 23, 2004 |
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10364212 |
Feb 10, 2003 |
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6732739 |
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10364212 |
Feb 10, 2003 |
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09770519 |
Jan 25, 2001 |
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6539945 |
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09770519 |
Jan 25, 2001 |
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08801494 |
Feb 18, 1997 |
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6182664 |
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08801494 |
Feb 18, 1997 |
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08603313 |
Feb 19, 1996 |
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5752526 |
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Current U.S.
Class: |
128/898 ;
623/2.11 |
Current CPC
Class: |
A61B 17/0218 20130101;
A61B 2017/00243 20130101; A61B 17/02 20130101; Y10S 623/902
20130101; A61F 2/2466 20130101; Y10S 623/914 20130101; A61F 2/2427
20130101; A61F 2/2445 20130101; A61B 17/00234 20130101; Y10S
623/922 20130101; Y10S 623/918 20130101 |
Class at
Publication: |
128/898 ;
623/002.11 |
International
Class: |
A61F 002/24 |
Claims
1-19. (canceled)
20. A surgical retractor for use in performing minimally invasive
cardiac surgery through an incision approximately 5 to 10 cm in
length, wherein said incision enables direct access to the heart
and is confined to a substantially rectangular area on the chest
and wherein said rectangular area extends approximately two inches
on either side of the sternum and from no higher than the first
intercostal space at the top to the sixth intercostal space at the
bottom, said retractor comprising: an elongated, malleable portion
of material having a distal end, a middle portion and a proximal
end; said distal end configured to have an angled planar edge
portion for holding heart tissue away form a surgical site in said
incision and to thereby decrease any visual obstruction to the
surgeon of said surgical site.
21. A surgical retractor as set forth in claim 20, wherein said
retractor is a hand held retractor.
22. A surgical retractor as set forth in claim 20, wherein said
retractor is attachable to a incision retracting platform.
23. A surgical retractor as set forth in claim 20, wherein said
distal end of said retractor is rounded so as to minimize trauma to
tissue during use of said retractor.
24. A surgical retractor as set forth in claim 20, wherein said
middle portion is substantially perpendicular to said planar
portion.
25. A surgical retractor as set forth in claim 24, wherein said
distal end is shorter in length than said middle portion.
26. A surgical retractor for use in performing minimally invasive
cardiac surgery through an incision approximately 5 to 10 cm in
length, wherein said incision enables direct access to the heart
and is confined to a substantially rectangular area on the chest
and wherein said rectagular area extends approximately two inches
on either side of the sternum and from no higher than the first
intercostal space at the top to the sixth intercostal space at the
bottom, said retractor comprising: a substantially circular,
radially compressible ring for placement in a chamber of the heart
through said incision; said ring having sufficient resiliency in
the radial direction to hold resected tissue of a heart chamber
away from a surgical site.
27. A surgical retractor as set forth in claim 26, wherein said
retractor has a substantially constant cross-sectional
diameter.
28. A surgical retractor as set forth in claim 26, wherein said
retractor has a substantially constant diameter.
29. A surgical retractor as set forth in claim 26, wherein said
retractor is sized to be placed within a space between a mitral
valve and a left atrial wall of a patient undergoing heart
surgery.
30. A kit of surgical instruments for use in performing minimally
invasive cardiac surgery trough an incision approximately 5 to 10
cm in length, wherein said incision enables direct access to the
heart and is confined to a substantially rectangular area on the
chest and wherein said rectangular area extends approximately two
inches on either side of the sternum and from no higher than the
first intercostal space at the top to the sixth intercostal space
at the bottom, said instrument comprising: a retrograde
cardioplegia cannula for introduction into the coronary sinus
through a peripheral vein such that said cannula is not visible
through said approximately 5 to 10 cm incision; an aortic occluding
balloon cannula for introduction through the sub-clavian artery
such that said cannula is not visible through said approximately 5
to 10 cm incision; an arterial return cannula and a venous return
cannula for introduction intraluminally into the arterial and
venous system, respectively, such that said cannulae are not
visible through said approximately 5 to 10 cm incision; a malleable
elongated retractor for holding resected tissue away from a
surgical site in said approximately 10 cm incision such that visual
obstruction to the surgeon is minimized; and, a substantially
circular, radially compressible retractor insertable into said
approximately 5 to 10 cm incision for holding resected tissue of a
heart chamber.
31. A kit set forth in claim 30, wherein said elongated retractor
has a distal end, a middle portion and a proximal end.
32. A kit as set forth in claim 31, wherein said distal end is
configured to have an angled planar edge portion for holding heart
tissue away from a surgical site in said incision and to thereby
decrease any visual obstruction to the surgeon of said surgical
site.
33. A kit as set forth in claim 31 wherein said distal end of said
elongated retractor is rounded so as to minimize trauma to tissue
during use of said retractor.
34. A kit as set forth in claim 32, wherein said middle portion of
said elongated retractor is substantially perpendicular to said
planar portion.
35. A kit as set forth in claim 32, wherein said distal end of said
elongated retractor is shorter in length than said middle
portion.
36. A kit as set forth in claim 30, wherein said circular retractor
has sufficient resiliency in the radial direction to hold resected
tissue of a heart chamber allay from a surgical site.
37. A kit as set forth in claim 30, wherein said circular reactor
has a substantially constant cross-sectional diameter.
38. A kit as set forth in claim 30, wherein said circular retractor
has a substantially constant diameter.
39. A kit as set forth in claim 30, wherein said retractor is sized
to be placed within a space between a mitral valve and a left
atrial wall of a patient undergoing heart surgery.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of U.S.
application Ser. No. 10/364,212 which is a divisional of U.S.
application Ser. No. 09/770,519, filed Jan. 25, 2001, which is a
continuation of U.S. application Ser. No. 08/801,494, filed Feb.
18, 1997, now issued as U.S. Pat. No. 6,182,664, which is a
continuation-in-part of U.S. application Ser. No. 08/603,313, filed
Feb. 19, 1996, now issued as U.S. Pat. No. 5,752,526.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to surgical procedures and,
more specifically, to minimally invasive procedures for mitral and
aortic valve repair or replacement surgeries including making small
access incisions in the sternal area.
[0004] 2. Description of the Related Art
[0005] Various types of surgical procedures are performed on the
heart and the great vessels. Many of such procedures, particularly
those involving the aorta, and aortic valve employ a gross
thoracotomy, e.g., a median sternotomy, in order to gain access to
the involved portion of the heart or vessel. In other words, the
procedures entail splitting open the patient's chest. Such
procedures cause significant trauma to the patient, and recovery
time.
[0006] An example is the conventional procedure for aortic valve
surgery. The patient is anesthetized, and the skin is incised from
the top of the sternum to a point located a predetermined distance,
e.g., approximately two inches, below the bottom of the sternum.
The sternum is then split longitudinally, using a saw or other
cutting implement. A spreader is placed within the chest cavity and
the opposing halves of the rib cage spread apart to expose the
thoracic cavity. The tissues around the heart are divided, opening
the pericardial sack. A cardiopulmonary bypass is initiated through
direct aortic and right atrial cannulation (that is, circulation to
a heart-lung machine is established through an arterial-returning
catheter disposed in the aorta and a venous drainage catheter in
the right atrium); the aorta is clamped (typically between the
brachycephalic artery and the coronary ostia) to exclude the heart
from the circulation. The cardiac function is then arrested, i.e.,
the heart is stopped by infusion of a cardioplegia fluid, such as a
cold potassium solution. The aorta is then opened. The valve is
then repaired, or if to be replaced, excised and a replacement
valve sewn in. Any air that may have accumulated in the heart
during the procedure is then removed from the heart and the aorta
closed with sutures. The clamp is then removed, patient weaned from
the heart-lung machine, tubes removed from the aorta, the sternum
wired back together and the skin closed with sutures.
[0007] Such procedures are particularly traumatic. Incisional pain
tends to require significant postoperative analgesia and
postoperative discomfort tends to result in significant patient
morbidity and lengthy hospital stays. In addition, because the
pericardial sack is opened underlying the sternum, after the
procedure the heart has a tendency to become adherent to the
sternum. This can be problematical in the event of subsequent
procedures.
[0008] The desirability of avoiding the use of median sternotomy,
and other gross thoracotomy procedures, in connection with surgery
on the heart and the great vessels has been recognized. For
example, techniques have been proposed in which a scope is inserted
through a percutaneous intercostal penetration in the patient's
chest (an incision between the ribs) to observe internal procedures
performed by instruments introduced into the chest with the scope,
or through cannula disposed in other intercostal spaces, i.e.,
between two adjacent ribs. Such techniques and instruments for
performing such techniques within the heart and great vessels is
described in International Publication WO 95/15715 by Sterman, et
al., published Jun. 15, 1995. However, such techniques require
special instrumentation and special skills to perform, and may
extend the time the heart is arrested and the duration of the
procedure.
SUMMARY OF THE INVENTION
[0009] The present invention provides a minimally invasive approach
for mitral or aortic valve surgeries. In accordance with one aspect
of the present invention, a parasternal incision is made extending
across a predetermined number of costal cartilages, e.g., a right
parasternal incision extending from the lower edge of the second
costal cartilage to the superior edge of the fifth costal
cartilage. One or more costal cartilages, e.g., the third and
fourth, are then excised to provide access to the mitral valve, and
a desired mitral valve repair or replacement procedure completed.
In accordance with another aspect of the invention an approximately
10 cm incision is made transverse to the sternum over the second
intercostal space. The sternum is then divided thereby exposing
access to the ascending aorta, and a desired aortic valve
replacement procedure completed.
[0010] A minimally invasive procedure for repair or replacement of
the aortic valve is disclosed that includes making a transverse
incision of about 10 cm in length over the second or third
intercostal space in the thorax of the patient, dividing the
sternum transversely following the incision, retracting the
transversely divided sternum, exposing the ascending aorta, and
incising the ascending aorta to provide access to an area adjacent
the aortic valve.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] A preferred exemplary embodiment of the present invention
will hereinafter be described with reference to the appended
drawing, wherein like denominations indicate like elements,
and;
[0012] FIGS. 1 and 1A are schematic illustrations depicting a human
chest and the disposition of a right parasternal incision in
connection with an aortic surgery procedure in accordance with the
present invention;
[0013] FIG. 2 is a pictorial illustration depicting the right
parasternal incision of FIG. 1 showing respective costal
cartilages;
[0014] FIG. 3 is a pictorial illustration depicting the right
parasternal incision of FIG. 1 after respective costal cartilage
units are excised and the incision retracted;
[0015] FIG. 4 is a schematic illustration depicting the disposition
of respective by-pass cannula employed in connection with an aortic
surgery procedure in accordance with the present invention;
[0016] FIG. 5 is a schematic illustration depicting an alternative
disposition of respective by-pass cannula employed in connection
with an aortic surgery procedure in accordance with the present
invention;
[0017] FIG. 6 is a pictorial illustration depicting the right
parasternal incision of FIG. 1 after the aorta is opened to expose
the aortic valve;
[0018] FIG. 7 is a pictorial illustration of injection of
cardioplegia into the coronary ostia;
[0019] FIG. 8 is a pictorial illustration depicting the right
parasternal incision of FIG. 1 after the aortic valve is removed,
with traction sutures placed at the commissures;
[0020] FIG. 9 is a pictorial illustration depicting insertion of an
aortic valve prosthesis;
[0021] FIG. 10 is a pictorial illustration depicting closure of the
aorta;
[0022] FIG. 11 is a pictorial illustration depicting the
disposition of temporary pacer leads and a drainage tube;
[0023] FIG. 12 is a pictorial illustration depicting a right
parasternal incision after respective costal cartilage units are
excised and the incision retracted;
[0024] FIG. 13 is a pictorial illustration depicting the surgery
field of FIG. 12 after an incision of the right atrium;
[0025] FIG. 13A is a pictorial illustration depicting an
alternative way of occluding the aorta;
[0026] FIG. 13B is a pictorial illustration depicting an
alternative way of occluding the aorta;
[0027] FIG. 14 is a pictorial illustration depicting the surgical
field of FIG. 12 after an incision of the inter-atrial wall;
[0028] FIG. 15 is a pictorial illustration depicting the surgical
field of FIG. 12 after the tissue has been retracted.
[0029] FIG. 15A and 15B are a pictorial illustration depicting
alternative ways of exposing the surgical field of FIG. 15;
[0030] FIG. 16 is a pictorial illustration of the performance of an
annuloplasty in the surgical field of FIG. 15;
[0031] FIG. 17 is a pictorial illustration of the performance of an
annuloplasty in the surgical field of FIG. 15;
[0032] FIG. 18 is a pictorial illustration of the completion of an
annuloplasty in the surgical field of FIG. 15;
[0033] FIG. 19 is a pictorial illustration of the closure of the
inter-atrial wall as incised in FIG. 14;
[0034] FIG. 20 is a pictorial illustration of the closure of the
right atrium as shown incised in FIG. 15;
[0035] FIG. 21 is a pictorial illustration of a transverse incision
across the sternum;
[0036] FIG. 22 is a pictorial illustration of the exposed surgical
field of the incision of FIG. 21;
[0037] FIG. 23 is a pictorial illustration of an incised aorta in
the surgical field of FIG. 22;
[0038] FIG. 24 is a pictorial illustration of a surgical procedure
on the aortic valve in the surgical field of FIG. 22;
[0039] FIG. 25 is a pictorial illustration of the replacement of an
aortic valve in the surgical field of FIG. 22;
[0040] FIG. 26 is a pictorial illustration of the closure of the
aorta in the surgical field of FIG. 22; and,
[0041] FIG. 27 is a pictorial illustration of the surgical field of
FIG. 22 after completion of the surgery.
DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0042] Referring now to FIG. 1, in a typical human, a sternum 10, a
planary bone structure centrally disposed in the chest, is
connected to a plurality of ribs 12 by respective costal cartilages
14.sub.R1, 14.sub.R2, 14.sub.R3, 14.sub.R4, 14.sub.R5, and
14.sub.L1, 14.sub.L2, 14.sub.L3, 14.sub.L4, 14.sub.L5. The heart
and great vessels are located within a tissue sack (pericardium),
located beneath the sternum, extending laterally under the costal
cartilages and ribs, with the aorta disposed in part underlying the
second and third right costal cartilages 14.sub.R2 and 14.sub.R3
and a portion of the right coronary artery located generally
underlying the vicinity of the fourth and fifth right costal
cartilages 14.sub.R4 and 14.sub.R5.
[0043] In accordance with one aspect of the present invention, it
has been determined that a surgery on portions of the heart and
great vessels located between a point approximately three
centimeters above the supra annular ridge and the mid-ventricular
cavity, can be effected with minimal invasion, without a median
sternotomy, or other gross thoracotomy, by, as illustrated in FIG.
1A, making a relatively short parasternal incision 16 extending
across a predetermined number of costal cartilage, e.g., a right
parasternal incision extending from the lower edge of the second
costal cartilage 14.sub.R2 to the superior edge of the fifth costal
cartilage 14.sub.R5 and removing one or more costal cartilages,
e.g., the third and fourth costal cartilages, 14.sub.R3 and
14.sub.R5. It has been determined that over a period of time the
chest wall in the area of the resected cartilages becomes stable
secondary to scarring of the remaining tissue. In effect, scar
tissue resulting from the procedure functionally replaces the
excised cartilage, providing a relatively rigid chest wall.
[0044] This procedure can be readily employed to perform operations
on structures located on portions of the heart and great vessels
located between a point approximately three centimeters above the
supra annular ridge and the mid-ventricular cavity. As will be more
fully described, the procedure is of particular utility with
respect to surgery to repair or replace the aortic valve. Further,
in some instances, the minimally invasive approach of the present
invention can be employed to effect a variety of other operations,
such as, for example, septal myectomy (excision of a portion of the
muscle just below the aortic valve to correct an obstruction to the
outflow of the heart); closure of a ventricular septal defect
(e.g., a congenital hole in the heart); and correction of
aneurysms.
[0045] The minimally invasive approach of the present invention is
particularly advantageous as compared to a median sternotomy. In
addition to decreased trauma to the patient, and the attendant
benefits, the minimally invasive technique provides additional
advantages in the event of repeat surgery. Since the pericardial
sack underlying the sternum is opened under the sternum in a median
sternotomy, after the procedure the heart has a tendency to adhere
to the sternum. This can be problematical in the event of
subsequent procedure; there is a risk of cutting into the heart
when sawing through the sternum during the subsequent operation. In
contradistinction, in the procedure according to the present
invention, the pericardium underlying the sternum remains intact,
normal tissue is retained between the sternum and the heart and
there is no risk of the heart adhering to the sternum. A series of
operations are relatively common in connection with correction of
congenital heart disease.
[0046] As noted above, the minimally invasive approach of the
present invention is of particular utility with respect to surgery
to repair or replace the aortic valve. Specifically, in the context
of exemplary surgery to replace an aortic valve, the patient is
anesthetized and intubated, and placed supine on the operating room
table. Preferably, defibrillator pads are placed on the patient's
back and anterior left chest, and a transesophageal
echocardiography probe is placed to access the etiology of the
aortic valve disease and to assist in removing air from the heart
after completion of the operation.
[0047] Referring to FIGS. 1 and 1A, a right parasternal incision is
made extending from the lower edge of the second costal cartilage
14.sub.R2 to the superior edge of the fifth costal cartilage. The
pectoral major muscle is divided, exposing the second, third, and
fourth intercostal spaces, and the third and fourth costal
cartilages 14.sub.R3 and 14.sub.R4 as shown in FIG. 2. The third
and fourth costal cartilages 14.sub.R3 and 14.sub.R4 are totally
excised (FIG. 1A). The right internal thoracic artery is ligated
just below the second costal cartilage 14.sub.R2 and just above the
fifth costal cartilage 14.sub.R5 Intercostal muscles and pleura are
incised lateral to the edge of the sternum, entering the right
pleural cavity. As shown in FIG. 3, the pericardium 18 is then
incised, exposing the ascending aorta 30, and is stitched back. The
incision is held open using a conventional chest retractor 34.
[0048] A cardiopulmonary by-pass is then established. Referring now
to FIG. 4, a common femoral artery 20 and vein 22 are exposed and,
after infusion of an anti-coagulant, e.g., heparinization, are
cannulated. Catheters 24 and 26 are placed in femoral artery 20 and
in femoral vein 22, respectively. Adequate venous drainage may be
obtained by utilizing a long venous cannula 26 disposed so that the
tip of the cannula passes through the right atrium 35 and
preferably into the superior vena cava 28 (FIG. 3). Alternatively,
as illustrated in FIG. 5, venous return can be effected by
introducing an appropriate catheter 50 into the right atrial
appendage 35. (The anatomy depicted in FIG. 5 illustrates the
results of additional steps in the procedure, as will be
explained). Catheters 24 and 26 direct the blood to a conventional
heart-lung machine (not shown) which oxygenates the blood and pumps
it back under pressure to the patient.
[0049] Referring to FIG. 6, after catheters 24 and 26 are placed,
the heart is excluded from circulation: aorta 30 is suitably
encircled with umbilical tape 72 and the ascending aorta 30 cross
clamped with a right angle clamp 74.
[0050] With continued reference to FIG. 6, the aorta is then
incised (along line 32, FIG. 3) to expose the coronary ostia 75 and
the aortic valve 76. Aortic valve 76 includes a plurality,
typically three, of leaflets (valve cusps) 78, joined at respective
commissures 80, and surrounded by a relatively fibrous aortic
annulus 82.
[0051] Cardiac function is arrested, by e.g., by administering
cardioplegia into the ascending aorta. Referring now to FIG. 7,
after performing the aortatomy, a suitable cardioplegia is
introduced into the left coronary artery. Preferably, a suitable
cardioplegia fluid, such as a cold potassium solution is infused
through a catheter 94 inserted in coronary ostia 75. Sutures 86 are
then suitably placed just above each commissure 80, and clamped
under tension to a drape (not shown) surrounding the operating
site. This elevates the aortic root (e.g., aortic annulus 82) into
the operative field.
[0052] Aortic valve 76 is then either repaired or replaced. For
example, referring to FIGS. 8 and 9, where a valve replacement is
effected, valve cusps 78 are excised, leaving aortic annulus 82
(FIG. 8; see also FIG. 5). A multiplicity of sutures 100 are then
placed through aortic annulus 82 about the periphery of the void
left by excision of the valve cusps 78 (FIG. 9). Sutures 100 are
then employed to secure a suitable replacement valve 102.
Replacement valve 102 may be, e.g., a bioprosthesis (cusps formed
from animal tissue coupled to a suitable peripheral sewing ring,
formed of e.g., polyester velour), a mechanical prosthesis (cusps
formed from e.g., pyrolytic carbon with a suitable peripheral
sewing ring 103, formed of e.g., polyester velour), or a homograft
(e.g., formed from human tissue which was frozen in liquid
nitrogen, then thawed). Attachment of the bioprosthesis and
mechanical prosthesis replacement valves are suitably facilitated
using a conventional insertion tool 104. Replacement valve 102 is
typically attached to aortic annulus 82 by passing sutures 100
through sewing ring 103 of the replacement. A vent is
intermittently placed into the left ventricle through the aortic
annulus as needed.
[0053] At the completion of the repair or replacement, the
aortatomy is closed with sutures 100, as shown in FIG. 10. Air is
then removed from the heart through the aorta with the assistance
of the transesophageal echocardiography probe; all air bubbles are
preferably removed from the heart by removing clamp 74 to restore
blood flow, and inflating the lungs, until blood flows through
sutures 110, then tightening the sutures.
[0054] Referring to FIG. 11, temporary pacemaker leads 120, 122 are
placed on the atrium and on the ventricle to facilitate temporary
pacing should it be necessary. The patient is weaned from
cardiopulmonary bypass, the femoral vessels are decannulated and
repaired, conventional right-sided pleural chest tubes 122 are
placed, and the femoral and right parastemal incisions are closed,
suitably by reapproximating the muscle, subcutaneous tissue and
skin, in layers.
[0055] In another aspect of the present invention, a similar
incision as that described above with reference to FIGS. 1, 1A and
2, can be used in performing surgery to repair or replace a mitral
valve. More specifically, referring to FIGS. 1A and 2, a
parasternal incision approximately 10 cm in length is made over the
third and fourth intercostal cartilages 14.sub.R3 and 14.sub.R3.
The pectoralis major muscle is then divided longitudinally,
exposing the third and fourth cartilages 14.sub.R3, 14.sub.R4. The
cartilages 14.sub.R3, 14.sub.R4 are completely resected and the
internal thoracic artery (not shown) is then ligated and divided.
The pericardium 18 is opened and suspended under tension to the
drapes of the patient.
[0056] Referring to FIG. 12, the resulting wound provides access
into the chest cavity and particularly exposes the first portion of
the ascending aorta 30, the superior vena cava 28 and the right
atrium 36. The wound also provides access for making a planned
incision 150 into the right atrium 36.
[0057] Referring to FIG. 13, prior to making the incision 150 into
the right atrium 36, the patient must be cannulated so that the
heart may be bypassed from blood flow during the surgery on the
heart. In that connection, a first cannula 152 is inserted directly
into the superior vena cava 28. A second cannula 210 (FIG. 23) may
be inserted into the inferior vena cava, either via the right
atrium 36 or via a venous cannula introduced through a femoral vein
as known in the art. Arterial return is established by a third
cannula 206 which may be inserted either directly into the
ascending aorta 30 as shown in FIG. 23 or through a femoral artery
as depicted in FIG. 4.
[0058] The cannulation configuration for heart bypass will be
dictated in large part by patient anatomy and physiology
particularly with regard to the size and placement of the heart
within the chest cavity, and the resulting effect of that anatomy
and physiology on the incision exposure. It is desirable, however,
to achieve as much of the bypass cannulation as possible through
the primary incision so as to reduce the number of incisions
otherwise made in the patient for peripheral cannulation as shown
in FIG. 14.
[0059] Once cannulation is complete, a cross clamp 160 is applied
to the ascending aorta 30 as shown in FIG. 14 to occlude blood
flow. Antegrade cardioplegia is then applied directly into the
ascending aorta proximal of the clamp via a cardioplegia catheter
162. Bypass is established and then the heart progressively
diminishes its beating activity until it ceases beating
altogether.
[0060] Referring to FIGS. 13A and 13B, it is appreciated that an
aortic occlusion balloon could alternatively be used to block the
ascending aorta for establishing bypass. In particular, an aortic
occlusion balloon catheter 161 could be introduced either through
the femoral artery, as shown in FIG. 13A, the sub-clavian artery as
shown in FIG. 13B or other vessel in a manner to position the
balloon between the coronary ostia and the brachycephalic artery of
the ascending aorta. Occlusion is achieved by inflating the balloon
so that the balloon contacts the internal wall of the aorta and
thereby blocks blood flow in the aorta. Cardioplegia may then be
introduced into the coronary ostia either directly through the
aorta as previously described or through a cardioplegia lumen
extending to a distal end of the aortic balloon catheter.
[0061] With further reference to FIG. 13B, it is appreciated that
under certain circumstances, in accordance with the method of the
present invention can be performed using a retrograde application
of cardioplegia. The retrograde cardioplegia catheter placed in the
coronary ostia through the jugular vein and the right atrium. It is
further appreciated that the type of cardioplegia used, whether
introduced antegrade or retrograde, will often be dictated by the
anatomy and physiology of the patient or by the preference of the
physician.
[0062] Once bypass is established, the incision 150 into the right
atrium 36 is made and the tissue draped back to expose the coronary
sinus 166 and intra-arterial septum 164 (FIG. 13). Additional
cardioplegia is introduced, as necessary, in a retrograde fashion
into the coronary sinus 166 with a retrograde cardioplegia catheter
168. The retrograde cardioplegia catheter 168 can be either a
conventional retrograde catheter or an occluding balloon catheter
to ensure proper introduction of the cardioplegia without leakage.
The stage is then set to cut the intra-atrial septum 164 along an
incision line 166 and thereby expose the dome of the left
atrium.
[0063] Referring to FIGS. 14 and 15, the incision 170 is made in
the intra-atrial septum 164 starting at the foramen ovale and
extending inferiorly and superiorly into the dome of the left
atrium. Hand-held refractors 172, 174 are then inserted into the
superior and inferior portions of the left atrium, respectively,
and used to pull the atrial tissue back and expose the mitral valve
176. Additionally, downward traction may be applied on the
posterior lateral left atrial wall 178 to provide better exposure
to the mitral valve 176. Referring to FIGS. 15A and 15B, a
deformable retractor 177, which may be manipulated into a shape
that grasps the tissue but does not obstruct the surgical field,
may be used to provide the downward traction on the posterior
lateral left atrial wall 178. In addition, to further expose the
surgical field, a flexible and resilient ring member 179 may be
inserted into the field between the valve 176 and the left atrial
wall. After the ring member is inserted, the ring 179 expands to
facilitate lifting the tissue away from the valve area requiring
surgery. The mitral valve 176 being fully exposed after achieving
the above-described configuration, repair or replacement of the
valve 176 may then be achieved in the conventional manner. By way
of example only, the procedure for completing the surgical method
after repair of a mitral valve is hereinafter described.
[0064] Referring to FIG. 16, after repair of the mitral valve 176,
an annuloplasty is performed. In particular, horizontal mattress
sutures 180 of multi-filament 2-0 are placed around the annulus of
the valve beginning with the fibrous trigone 182 and proceeding
around the posterior annulus of the opposite fibrous trigone 184.
The sutures 180 are then passed through the annuloplasty band 186
which is attached to a band holder or stent 188.
[0065] Referring to FIGS. 17 and 18, once placement of the sutures
is complete, the handle 190 of the stent 188 is released and the
stent 188 with the annuloplasty band 186 is guided into position
proximal to the mitral valve 176. The sutures 180 are tightened and
tied down thereby securing the annuloplasty band 186 into place.
The stent 188 is then released and removed from the band 186 thus
leaving the repaired valve 176.
[0066] It is appreciated that the use of other types of
annuloplasty rings are contemplated in the just-described surgery.
For example, annuloplasty rings that requires suturing around the
entire periphery of the ring (e.g., a Carpentier ring or a Duran
ring) may be used without departure from the invention.
[0067] Referring to FIG. 19, the incision 170 into the interatrial
septum is sutured 192 back together using continuous 4-0 Prolene or
other suitable suture material. Attempts are made to remove all air
from the left atrium and then the sutures 192 are tightened and
tied down.
[0068] De-airing of the left ventricle is also effected at this
time. In that connection, just prior to release of the aortic clamp
160, gentle suction may be applied on the cardioplegia cannula 162
in the ascending aorta 30. Weaning from the cardiopulmonary bypass
is then initiated. The retrograde cardioplegia cannula 168 is
removed as is the aortic clamp 162, thereby restoring blood flow.
The lungs are then inflated until blood flows through the sutures
192. Suction through the cardioplegia cannula may continue as
needed after the aortic clamp 162 is removed.
[0069] Referring to FIG. 20, the incision 150 in the right atrium
is also closed using continuous 4-0 Prolene or other suitable
suture material. Simultaneously, the heart is being observed to
ensure a return to normal cardiac function and to ensure the
absence of air bubbles within the heart chambers. If the heart
function returns properly, the cannulae are removed and the
incisions from the cannulae placement are repaired as needed and
sutured shut.
[0070] Four pacemaker wires 120 are placed percutaneously through
the chest onto the atrium and the ventricle to facilitate temporary
pacing should it be necessary. Conventional pleural chest tubes as
depicted in FIG. 11 may also be placed in the chest. The wound is
then closed by suitably reappoximating the muscle, subcutaneous
tissue and the skin, in layers.
[0071] Referring to FIG. 21, in another approach to minimally
invasive surgery in accordance with the present invention, the
patient is anesthetized in the supine position and intubated.
Defibrillator patches (not shown) are placed on the patient's back
and anterior left chest wall. A transesophageal cardiography probe
(not shown) is placed to assess the etiology of the tissue
requiring surgery, which by way of example only, is the aortic
valve in this embodiment. The cardiography probe is also useful in
the removal of air from the heart prior to completion of the
surgery.
[0072] Referring to FIGS. 21 and 22, a 10 cm transverse incision is
made over the second intercostal space. In certain circumstances,
it may be appropriate to make the incision over the third
intercostal space, depending on the location of the targeted
surgical area. The subcutaneous tissue and pectoralis muscles are
divided. The internal thoracic artery (not shown) is ligated and
divided bilaterally. The tissue is retracted and draped back to
better expose the surgical area. A sternal saw (not shown) is then
used to divide the sternum 204 transversely in alignment with the
original incision 200. A retractor 35, such as a Finochietto
retractor, is placed between the two bisected portions of the
sternum 204 and the sternum opened. The separation of the sternum
204 and the subsequent cutting and retracting of the pericardium
exposes the entire ascending aorta 30, the superior vena cava 28
and the tip of the right atrial appendage 36.
[0073] Referring to FIG. 23, the patient is cannulated for heart
bypass by inserting an arterial return cannula 206 directly into
the ascending aorta 30 and a venous drain cannula 208 into the
superior vena cava 28. A venous drain cannula 210 is also inserted
into the inferior vena cava through a percutaneous incision 212
proximal to the original incision opening.
[0074] Once cannulation is completed, the aorta 30 is occluded at a
position proximal, of the brachycephalic artery and distal of the
coronary ostia 222 with a cross-clamp 216 and bypass of blood flow
around the heart is initiated. As discussed previously, an aortic
occlusion balloon inserted through a femoral artery or sub-clavian
artery could also be used to block the aorta 30. A transverse
incision 218 is made in the aorta 30 from a position proximal to
the clamp 216 into the noncoronary cusp 220, which incision exposes
the coronary ostia 222 and the aortic valve 224.
[0075] Referring to FIG. 24, sutures 226 are placed at the top of
each commissure 228 of the valve 224 and draped under tension
outside the wound so as to elevate the valve 224, retract the aorta
30 and give a normal anatomical orientation to the aortic root.
Cardioplegia is then introduced into one of the coronary ostia 222
with an antegrade cardioplegia catheter 230. The cardiac activity
of the heart then progressively diminishes until the heart ceases
beating altogether.
[0076] Referring to FIG. 25, replacement of the aortic valve is
effected by excising the native aortic valve tissue and placing
sutures 232 around the annulus of the aortic root. The sutures 232
are then placed through the sewing ring of the aortic valve
prosthesis 234 which is attached to a valve holder 236. The
prosthesis 234 is then guided into location, the sutures 232
tightened and tied and the holder 236 removed.
[0077] Referring to FIGS. 25 and 26, the sutures 226 through the
commissures 228 are maintained in tension until closure of the
aorta 30 is begun in order to enable proper exposure of the field.
Closure of the aorta 30 is begun by applying a single layer of 4-0
Prolene or other suitable material to bring the edges of the
incision together. The sutures 226 attached to the commissures 228
are then cut.
[0078] Prior to completion of the closure of the aorta 30, care is
taken to remove air from the left ventricle. The lungs are inflated
and blood is allowed to flow into the aorta 30 by releasing the
clamp 216 which enables air to escape through the remaining open
portion of the incision, which portion is held open with a tool
240. The completeness of the air removal is monitored by
echocardiography.
[0079] Referring to FIG. 27, the patient is further weaned from
bypass and closure of the incision 218 is completed. Assuming
normal cardiac function returns, the patient is then decannulated
and the wounds from the cannulation repaired and closed. Two atrial
and two ventricular pacing wires 242, 244 are placed percutaneously
into the chest for pacing the heart if necessary. A pleural chest
tube 122 is also placed in the chest.
[0080] The retractor 35 is then removed and the sternum 204 is
closed with monofilament wire or any other suitable material. The
incision 200 is then closed by reapproximating the muscles, the
subcutaneous tissue and skin, in layers.
[0081] The minimally invasive valve surgery in accordance with the
present invention simplifies the cardiac surgery for surgeons and
provides beneficial results for patients. The operative procedure
allows for a relatively small, e.g., ten centimeter, incision that
makes opening and closing of the chest easier and faster without
compromising the surgical exposure or access to the surgical area.
Performing repairs or replacements through an incision in
accordance with the present invention simplifies the surgical
technique without increasing the difficulty of the procedure or the
technical ability required to perform aortic valve surgery.
Further, the smaller incision employed in the procedure results in
less bleeding, and a lesser area to become infected.
[0082] Moreover, not only does the smaller incision tend to cause
less incisional pain in patients, the absence of traumatic
retraction and the strain placed on the ribs from a gross
thoracotomy tends to also account for lower incisional pain.
Without incisional pain, patients require less postoperative
analgesia and are more easily ambulated allowing for earlier
discharge from the hospital. Decreased patient morbidity as a
result of decreased postoperative discomfort tends to result in
shorter length of hospital stays.
[0083] The foregoing is a description of preferred exemplary
embodiments and best mode of the invention contemplated by
applicant at time of filing the application. The invention is not
limited to the specific embodiments shown. Rather, the scope of the
invention is expressed in the appended claims.
* * * * *