Less-invasive devices and methods for treatment of cardiac valves

Devices and methods are provided for less-invasive surgical treatment of cardiac valves whereby the need for a gross thoracotomy or median sternotomy is eliminated. In one aspect of the invention, a delivery system for a cardiac valve prosthesis such as an annuloplasty ring or prosthetic valve includes an elongated handle configured to extend into the heart through an intercostal space from outside of the chest cavity, and a prosthesis holder attached to the handle for releasably holding a prosthesis. The prosthesis holder is attached to the handle in such a way that the holder, prosthesis and handle have a profile with a height smaller than the width of an intercostal space when the adjacent ribs are unretracted, preferably less than about 30 mm. In a further aspect, the invention provides a method for repairing or replacing a heart valve which includes the steps of introducing a prosthesis through an intercostal space and through a penetration in a wall of the heart, and securing the prosthesis to an interior wall of the heart, wherein each step is carried out without cutting, removing, or significantly retracting the ribs or sternum.

FIELD OF THE INVENTION 
The present invention relates generally to devices and methods for 
performing surgery on the heart. More specifically, the invention relates 
to less-invasive devices and methods for the surgical treatment of 
diseased heart valves. 
BACKGROUND OF THE INVENTION 
Heart valve disease is a widespread condition in which one or more of the 
valves of the heart fails to function properly. Diseased heart valves may 
be categorized as either stenotic, wherein the valve does not open 
sufficiently to allow adequate forward flow of blood through the valve, or 
incompetent, wherein the valve does not close completely, causing 
excessive backward flow of blood through the valve when the valve is 
closed. A heart valve may also be both stenotic and incompetent. Valve 
disease can be severely debilitating and even fatal if left untreated, 
particularly if the diseased valve is the mitral valve (between the left 
atrium and left ventricle) or the aortic valve (between the left ventricle 
and the aorta). According to recent estimates, more than 80,000 patients 
are diagnosed with aortic or mitral valve disease in U.S. hospitals each 
year. 
Various surgical techniques may be used to repair a diseased or damaged 
valve. One repair technique which has been shown to be effective in 
treating incompetence, particularly of the mitral and tricuspid valves, is 
annuloplasty, in which the effective size of the valve annulus is 
contracted by attaching a prosthetic annuloplasty ring to an interior wall 
of the heart around the valve annulus. The annuloplasty ring comprises an 
inner substrate of a metal such as stainless or titanium, or a flexible 
material such as silicone rubber or Dacron cordage, covered with a 
biocompatible fabric or cloth to allow the ring to be sutured to the heart 
tissue. The annuloplasty ring may be stiff or flexible, may be split or 
continuous, and may have a variety of shapes, including circular, 
D-shaped, C-shaped, or kidney-shaped. Examples are seen in U.S. Pat. Nos. 
4,917,698, 5,061,277, 5,290,300, 5,350,420, 5,104,407, 5,064,431, 
5,201,880, and 5,041,130, which are incorporated herein by reference. 
Annuloplasty rings may also be utilized in combination with other repair 
techniques such as quadrangular resection, in which a portion of a valve 
leaflet is excised, the remaining portions of the leaflet are sewn back 
together, and a prosthetic annuloplasty ring is then attached to the valve 
annulus to maintain the contracted size of the valve. Other valve repair 
techniques in current use include commissurotomy (cutting the valve 
commissures to separate the valve leaflets), shortening mitral or 
tricuspid valve chordae tendonae, reattachment of severed mitral or 
tricuspid valve chordae tendonae or papillary muscle tissue, and 
decalcification of the valve leaflets or annulus. Annuloplasty rings may 
be used in conjunction with any repair procedures where contracting or 
stabilizing the valve annulus might be desirable. 
In cases where a cardiac valve is not suited to repair, the valve may be 
replaced, by excising the valve leaflets of the natural valve, and 
securing a replacement valve in the valve position, usually by suturing 
the replacement valve to the natural valve annulus. Various types of 
replacement valves are in current use, including mechanical and biological 
prostheses, homografts, and allografts, as described in Bodnar and Frater, 
Replacement Cardiac Valves 1-357 (1991). A comprehensive discussion of 
heart valve diseases and the surgical treatment thereof is found in 
Kirklin and Barratt-Boyes, Cardiac Surgery 323-459 (1986). 
Using current techniques, most valve repair and replacement procedures 
require a gross thoracotomy, usually in the form of a median sternotomy, 
to gain access into the patient's thoracic cavity. A saw or other cutting 
instrument is used to cut the sternum longitudinally, allowing two 
opposing halves of the anterior or ventral portion of the rib cage to be 
spread apart. A large opening into the thoracic cavity is thus created, 
through which the surgical team may directly visualize and operate upon 
the heart and other thoracic contents. Alternatively, a thoracotomy may be 
performed on a lateral side of the chest, wherein a large incision is made 
generally parallel to the ribs, and the ribs are spread apart and/or 
removed in the region of the incision to create a large enough opening to 
facilitate the surgery. 
Surgical intervention within the heart generally requires isolation of the 
heart and coronary blood vessels from the remainder of the arterial 
system, and arrest of cardiac function. Usually, the heart is isolated 
from the arterial system by introducing an external aortic cross-clamp 
through a sternotomy and applying it to the aorta to occlude the aortic 
lumen between the brachiocephalic artery and the coronary ostia. 
Cardioplegic fluid is then injected into the coronary arteries, either 
directly into the coronary ostia or through a puncture in the ascending 
aorta, so as to arrest cardiac function. In some cases, cardioplegic fluid 
is injected into the coronary sinus for retrograde perfusion of the 
myocardium. The patient is placed on extracorporeal cardiopulmonary bypass 
to maintain peripheral circulation of oxygenated blood. 
Of particular interest in the present application are techniques for the 
repair and replacement of the mitral valve. The mitral valve, located 
between the left atrium and left ventricle of the heart, is most easily 
reached through the wall of the left atrium, which normally resides on the 
posterior side of the heart, opposite the side of the heart that is 
exposed by a median sternotomy. Therefore, to access the mitral valve via 
a sternotomy, the heart is rotated to bring the left atrium into an 
anterior position accessible through the sternotomy. An opening, or 
atriotomy, is then made in the right side of the left atrium, anterior to 
the right pulmonary veins. The atriotomy is retracted by means of sutures 
or a retraction device, exposing the mitral valve directly posterior to 
the atriotomy. One of the forementioned techniques may then be used to 
repair or replace the valve. 
An alternative technique for mitral valve access may be used when a median 
sternotomy and/or rotational manipulation of the heart are inappropriate. 
In this technique, a thoracotomy is made in the right lateral side of the 
chest, usually in the region of the fourth or fifth intercostal space. One 
or more ribs may be removed from the patient, and other ribs near the 
incision are retracted outward to create a large opening into the thoracic 
cavity. The left atrium is then exposed on the posterior side of the 
heart, and an atriotomy is formed in the wall of the left atrium, through 
which the mitral valve may be accessed for repair or replacement. 
Using such open-chest techniques, the large opening provided by a median 
sternotomy or right thoracotomy enables the surgeon to see the mitral 
valve directly through the left atriotomy, and to position his or her 
hands within the thoracic cavity in close proximity to the exterior of the 
heart for cannulation of the aorta and/or coronary arteries to induce 
cardioplegia, manipulation of surgical instruments, removal of excised 
tissue, and introduction of an annuloplasty ring or a replacement valve 
through the atriotomy for attachment within the heart. However, these 
invasive, open-chest procedures produce a high degree of trauma, a 
significant risk of complications, an extended hospital stay, and a 
painful recovery period for the patient. Moreover, while heart valve 
surgery produces beneficial results for many patients, numerous others who 
might benefit from such surgery are unable or unwilling to undergo the 
trauma and risks of current techniques. 
What is needed, therefore, are devices and methods for carrying out heart 
valve repair and replacement as well as other procedures within the heart 
and great vessels that reduce the trauma, risks, recovery time and pain 
that accompany current techniques. The devices and methods should 
facilitate surgical intervention within the heart or great vessels without 
the need for a gross thoracotomy, preferably through small incisions 
within intercostal spaces of the rib cage, without cutting, removing, or 
significantly deflecting the patient's ribs or sternum. In particular, the 
devices and methods should allow for removal of tissue from the thoracic 
cavity, as well as for introduction of surgical instruments, visualization 
devices, annuloplasty rings, replacement valves, and the like into the 
thoracic cavity, to facilitate heart valve repair and replacement. The 
devices and methods should enable the implantation of annuloplasty rings 
of various shape, size, and stiffness. In addition, the devices and 
methods should facilitate replacement of a heart valve with various types 
of prostheses, including mechanical and biological prostheses, homografts, 
and allografts. 
SUMMARY OF THE INVENTION 
The invention provides devices and methods for performing less-invasive 
surgical procedures within an organ or vessel, and particularly, within 
the heart and great vessels of the thoracic cavity. The devices and 
methods of the invention facilitate intervention within the heart and 
great vessels without the need for a median sternotomy or other form of 
gross thoracotomy, substantially reducing trauma, risk of complication, 
recovery time, and pain for the patient. Using the devices and methods of 
the invention, surgical procedures may be performed through percutaneous 
penetrations within intercostal spaces of the patient's rib cage, without 
cutting, removing, or significantly displacing any of the patient's ribs 
or sternum. The devices and methods are particularly well-adapted for 
heart valve repair and replacement, facilitating visualization within the 
patient's thoracic cavity, repair or removal of the patient's natural 
valve, and, if necessary, attachment of an annuloplasty ring or a 
replacement valve in the natural valve position. The invention facilitates 
valve repair with a variety of different annuloplasty rings, as well as 
valve replacement with any of a variety of replacement valves, including 
mechanical prostheses, bioprostheses, homografts, and allografts. 
According to the invention, access into the chest cavity and into the heart 
is obtained by means of small incisions, punctures, cannulae, trocars, or 
other percutaneous penetrations of minimal size positioned in the 
intercostal spaces between adjacent ribs of the rib cage. In this 
application, these percutaneous penetrations within intercostal spaces 
will be referred to as "intercostal ports". The intercostal ports utilized 
in the present invention will not require removal, cutting, or other 
modification of the ribs or sternum, and will generally avoid any 
significant retraction of the ribs, other than the incidental deflection 
of the ribs which may occur when a cannula, trocar, or other means of 
tissue retraction is placed in an intercostal space. Such retraction of 
ribs will generally be avoided entirely, and if occurring at all, will be 
limited to deflection of less than about one centimeter. Preferably, all 
such intercostal ports will have a width (or diameter, if round) of less 
than 30 mm in order to fit within an intercostal space without significant 
rib retraction, and in many cases will have a width of less than 12 mm so 
as to minimize trauma. 
In a first aspect, the invention provides a method of closed-chest repair 
of a heart valve. Utilizing the method of the invention, the patient's 
heart is arrested and cardiopulmonary bypass is established. The interior 
of the patient's chest cavity is viewed by means of a thoracoscope or by 
directly looking through a cannula or other retracting means positioned in 
an intercostal space. A knife or scissors is introduced through an 
intercostal port into the patient's chest, and the cutting means is used 
to first form an opening in the pericardium, then to form a cardiac 
penetration in a wall of the heart. One or more percutaneous cannulae, 
trocars, or other means of retracting tissue may be positioned in an 
incision or puncture within an intercostal space through which various 
instruments may be introduced into the chest cavity. These instruments may 
be positioned through the cardiac penetration to perform, for example, 
annuloplasty, quadrangular resection of valve leaflets, commissurotomy, 
reattachment of chordae tendonae or papillary muscle tissue, shortening of 
chordae tendonae, decalcification, and the like. Advantageously, all of 
these steps may be performed without cutting, removing, or substantially 
retracting the ribs or sternum, eliminating the pain, trauma, long 
recovery time, and complications associated with gross thoracotomy. 
The patient's heart is preferably arrested by occluding the patient's aorta 
between the patient's coronary ostia and the patient's brachiocephalic 
artery with an expandable member on a distal end of an endovascular aortic 
catheter introduced through a peripheral artery such as a femoral artery. 
Cardioplegic fluid is then delivered through a lumen in the catheter into 
the patient's aorta upstream of the expandable member to arrest cardiac 
function. Alternatively, or in addition to such antegrade cardioplegic 
fluid delivery, cardioplegic fluid may be delivered in a retrograde manner 
by means of a catheter positioned in the coronary sinus of the patient's 
heart. In an alternative approach, an external cross-clamp may be placed 
thoracoscopically on the aorta through a small incision or cannula in the 
patient's chest. Cardioplegic fluid may be delivered either through a 
cannula introduced thoracoscopically and inserted through the aortic wall, 
or through an endovascular aortic catheter extending from a peripheral 
artery into the ascending aorta upstream of the cross-clamp. 
In a preferred embodiment of the method, a prosthetic annuloplasty ring is 
introduced through an intercostal port and into an internal chamber of the 
heart, and the ring is attached to the heart wall around the annulus of 
the valve within the internal chamber. Usually, the valve will first be 
sized by introducing a sizing device through the intercostal port and into 
the heart through the cardiac penetration, and positioning the sizing 
device adjacent to the valve to measure its size. A valve sizing disk 
attached to an elongated shaft or handle may be used for this purpose. 
Once the valve size has been determined, sutures are inserted in the 
native valve annulus and an annuloplasty ring of appropriate size is 
selected. The ring is attached to an elongated handle and the ring is 
introduced through an intercostal port and through the cardiac penetration 
into the heart. The annuloplasty ring is then secured to the annulus of 
the heart valve, by tying knots in the sutures extracorporeally and 
pushing the knots into the heart with an elongated knot-pusher. The 
sutures are preferably applied to the annuloplasty ring outside of the 
chest cavity, and the ring is slid along the sutures through the 
intercostal port and cardiac penetration up to the valve annulus. The 
sutures are then tied and rimmed using thoracoscopic instruments. 
One advantage of the method of the invention is that it allows the surgeon 
to obtain access to the valve through an intercostal port and a cardiac 
penetration, assess the nature and extent of valve disease, and then 
decide whether to repair or replace the valve. If the disease is such that 
repair is inappropriate, the surgeon may elect to replace the valve with 
any of a variety of replacement valves. A valve replacement method 
according to the invention may include the step of removing all or part of 
the patient's natural heart valve by means of a cutting tool introduced 
through an intercostal port and through the cardiac penetration into the 
heart. The method further comprises the step of introducing a replacement 
valve through an intercostal port and through the cardiac penetration into 
the internal chamber of the heart. The replacement valve is then fastened 
within the heart, usually by means of a suturing instrument introduced 
through an intercostal port and through the cardiac penetration. As with 
the annuloplasty method described above, sutures are usually applied to 
the valve outside of the chest, and the valve is slid along the sutures 
into the heart. The sutures are then tied and trimmed. The method may 
further include the step of sizing the patient's heart valve before the 
replacement valve is introduced. In an exemplary embodiment, a sizing 
instrument is introduced through an intercostal port and through the 
cardiac penetration to measure the size of the valve annulus and to 
determine the size of the replacement valve. 
In order to suture the annuloplasty ring or replacement valve to the 
interior of the heart, the sutures are preferably applied to the heart 
tissue, drawn out of the patient's body through an intercostal port and 
then applied to the annuloplasty ring or replacement valve. The sutures 
may be radially arranged in spaced-apart locations about an organizer ring 
disposed outside of the patient's body. The sutures are then held in 
tension as the annuloplasty ring or replacement valve is introduced into 
the interior of the heart and positioned in the natural valve position. 
The annuloplasty ring or replacement valve may be introduced by means of a 
specialized holder attached to an elongated handle, or simply pushed along 
the sutures into the chest cavity by means of the surgeon's hands, then 
into the native valve position using conventional thoracoscopic 
instruments such as forceps or needle drivers. 
In a particularly preferred embodiment, the heart valve comprises a mitral 
valve which is disposed between the left atrium and left ventricle of the 
patient's heart. An intercostal port is created within an intercostal 
space in a right lateral portion of the patient's chest, usually within 
the third, fourth, or fifth intercostal space. From this intercostal port, 
a cardiac penetration may be formed in the wall of the left atrium at a 
location which is generally aligned with the intercostal port. In this 
way, surgical instruments may be introduced from the intercostal port in 
the right chest to form the cardiac penetration, repair or excise the 
patient's natural valve, and/or introduce and attach an annuloplasty ring 
or replacement valve. 
In a further aspect of the invention, a system is provided for repairing a 
heart valve. The system includes an annuloplasty device and a device 
holder for releasably holding the annuloplasty device to facilitate 
introducing it through an intercostal port and into the heart. The device 
holder includes connection means for connecting the holder to an elongated 
handle. The connection means is configured to connect to the handle such 
that the handle, holder, and annuloplasty device together have a profile 
with a profile height smaller than the width of the intercostal space, 
usually less than about 30 mm and preferably less than about 25 mm. The 
annuloplasty device has a bottom side which is positioned in contact with 
the wall of the heart around the heart valve when the device is implanted. 
The bottom side defines a first plane which is generally perpendicular to 
a longitudinal (axial) axis of the annuloplasty device. In an exemplary 
configuration, the connection means connects to the handle such that the 
longitudinal axis of the handle forms an angle with the first plane 
selected so that handle may be used to introduce the annuloplasty ring 
through the intercostal port without contacting or retracting the ribs 
adjacent the intercostal port. The angle will usually be about 
0.degree.+/-45.degree., and preferably 0.degree.+/-20.degree., but could 
also be outside of this range if the annuloplasty device is small relative 
to the size of the intercostal space. 
The holder also includes a means for retaining the annuloplasty device on 
the holder, such as retention sutures, a retaining clip, or a pivoting 
leaf on the holder. The system may further include means for releasing the 
annuloplasty device from the holder, such as a cutting device for cutting 
the retention sutures which hold the annuloplasty device on the holder, or 
other device for releasing the mechanism which secures the annuloplasty 
device to the holder. 
The annuloplasty device may be any of the commercially-available 
annuloplasty rings, may be either stiff or flexible, split or continuous, 
and may have any of a variety of shapes, including C-shaped, D-shaped, 
kidney-shaped, saddle-shaped racetrack-shaped, oval, semi-circular, and 
circular. The annuloplasty device may also be malleable or shapable into a 
desired shape, or may be flexible and resilient and secured in the heart 
in a shape which differs from its natural, unstressed shape. 
The valve repair system may further include an elongated handle having a 
distal end mounted to the device holder and a proximal end opposite the 
distal end. The handle is configured to introduce the annuloplasty device 
into the patient's heart through an intercostal port. Preferably, the 
handle is at least about 20 cm in length to allow positioning the 
annuloplasty device in the left atrium of the heart from a right lateral 
portion of the patient's chest. 
The handle may also include means for pivoting the annuloplasty device from 
a first orientation for introduction through the intercostal space to a 
second orientation for attachment in the patient's heart. The pivoting 
means is configured for actuation from a proximal end of the handle. In 
this way, the annuloplasty device may be introduced edge-first through the 
intercostal space, then pivoted about an axis generally perpendicular to 
the handle into an orientation suitable for attachment within the 
patient's heart, preferably wherein the first plane is perpendicular to 
the longitudinal axis of the handle. 
While a variety of mechanisms may be utilized for connecting the holder to 
the handle, in an exemplary embodiment, the handle has a tongue pivotably 
coupled to its distal end, a movable actuator coupled to its proximal end, 
and a rod or cable extending through a lumen in the handle connecting the 
actuator to the tongue. The tongue is received in an aperture in the 
device holder, and includes a spring catch or other means for retaining 
the tongue in the aperture. The aperture has an open proximal end, a 
distal end opposite the proximal end, and an axis therebetween defining 
the direction in which the tongue is received in the aperture. The 
aperture is preferably oriented so that the axis forms an angle of 
0.degree.+/-45.degree. relative to the first plane of the annuloplasty 
device, facilitating introduction through an intercostal port. In this 
way, the tongue may be aligned with the longitudinal axis of the handle 
for edge-first introduction of the annuloplasty device through the 
intercostal port, then pivoted to an appropriate angle, usually about 
90.degree., relative to the handle so that the first plane of the 
annuloplasty device is generally parallel to the interior wall of the 
heart to which it is to be attached. 
As an alternative to pivoting the annuloplasty device, the annuloplasty 
device and device holder may be flexible, collapsible, or compressible so 
that it may be deformed or constrained into a shape which allows the 
device and holder to be introduced through an intercostal space into the 
thoracic cavity. 
The system of the invention may also include a retraction means for 
retracting the chest wall tissue in a percutaneous penetration within an 
intercostal space, to facilitate introduction of instruments, 
visualization devices, valve sizers, annuloplasty devices, and replacement 
valves through the penetration without interference and without damaging 
tissue. The retraction means displaces the tissue around the percutaneous 
penetration to create a small opening, but does not significantly retract 
or deflect the ribs. The retraction means may comprise any of various 
types of tissue or wound retractors, but in a preferred embodiment 
comprises a cannula having a distal end positionable through the 
intercostal space and an inner lumen of sufficient size and shape to allow 
a replacement valve or annuloplasty device to be positioned through the 
cannula into the chest cavity. Preferably, the inner lumen has a width of 
between about 12 mm and about 30 mm, in order to allow the cannula to be 
positioned within the intercostal space with the ribs unretracted, while 
allowing the annuloplasty device or replacement valve to pass through the 
lumen with sufficient clearance. The inner lumen has a height of at least 
25 mm, and usually at least 35 mm, to permit introduction of the 
annuloplasty device or replacement valve. Usually, the height is larger 
than the width, in a preferred embodiment, at least about 1.5 times the 
width. In this way, the annuloplasty device or replacement valve may be 
introduced in an edge-first manner through the lumen of the cannula, then 
pivoted 90.degree. into a face-first orientation for attachment within the 
heart. 
Because the annuloplasty device or replacement valve may be attached within 
the heart with a plurality of individual sutures, the system may further 
include means for organizing sutures outside of the chest cavity. The 
suture organizing means preferably is attached to the proximal end of the 
access cannula described above, and comprises a plurality of slots 
arranged radially about the inner lumen of the cannula. In this way, as 
each suture is placed in the heart tissue, the free ends of the suture may 
be withdrawn through the lumen of the access cannula and placed in one of 
the slots. The free ends may then be placed through the sewing ring of the 
annuloplasty device or replacement valve, and the device or valve advanced 
through the inner lumen of the cannula and into the heart by sliding along 
the suture threads. 
Preferably, the annuloplasty device is premounted to the device holder and 
the two are sterilized and packaged together in a sterile pack. In this 
way, the pack may be opened in the sterile operating room environment with 
the annuloplasty device and holder ready for immediate use. In some 
embodiments, the elongated delivery handle, sizing disks, access cannula 
or other retraction means, suture organizer, and/or other system 
components may be included in the sterile pack with the annuloplasty 
device and holder. Alternatively, the annuloplasty device could be 
packaged separately from the device holder and the device mounted to the 
holder in the operating room at the time of the valve repair procedure. 
The delivery handle of the invention is configured not only for introducing 
the annuloplasty device through an intercostal port into the heart, but 
for introducing valve sizing devices and/or a replacement valve as well. 
In this way, the same handle may be used to first size the native valve, 
then to introduce an annuloplasty device to repair the mitral valve, or to 
introduce a replacement valve to replace the native valve. 
Accordingly, the invention also provides a device for sizing a valve which 
includes both an elongated handle and a sizing disk attached to the distal 
end of the handle. The sizing disk is configured to connect to the handle 
in an orientation in which the handle and the sizing disk together have a 
profile with a profile height smaller than the width of the intercostal 
space through which the sizing disk is introduced, usually less than about 
30 mm and preferably less than about 25 mm. In a preferred embodiment, the 
sizing disk is pivotably attached to the handle so that it may be 
introduced through the intercostal space in an edge-first orientation, and 
then pivoted into a face-first orientation for sizing the valve. The 
handle may have, as described above, a tongue pivotably mounted to its 
distal end which is received in an aperture on the sizing disk, allowing 
the sizing disk to be oriented with its face generally parallel to the 
longitudinal axis of the handle for introduction, then perpendicular to 
the longitudinal axis for sizing the valve. For sizing a valve for an 
annuloplasty repair, the sizing disk usually has a shape corresponding 
generally to the natural shape of the native valve annulus, which is 
roughly oval, kidney-shaped or D-shaped. The sizing disk also includes 
notches or markings to measure the spacing between the trigones or 
commisures of the valve. For valve replacement procedures, the sizing disk 
is preferably round, corresponding to the shape of the replacement valve 
sewing ring. 
The invention further provides a holder for a prosthesis for repairing or 
replacing a heart valve. The holder may be adapted for holding either an 
annuloplasty ring or a prosthetic heart valve. The holder includes a 
holder body having a top, a bottom, and a holder axis. A holding means is 
included on the holder body for releasably holding a prosthesis such that 
the central axis of the attachment ring of the prosthesis is approximately 
parallel to the holder axis. The holder further includes a connection 
means for connecting to an elongated handle for introducing the holder and 
prosthesis through an intercostal space. The connection means has a 
proximal end, a distal end, and a connection axis therebetween. The 
connection means is positioned on the holder body such that the connection 
axis is oriented at an angle relative to the holder axis selected so that, 
when the prosthesis is held by the holding means, the profile of the 
prosthesis and holder perpendicular to the connection axis has a height 
less than the width of the intercostal space, usually less than about 30 
mm and preferably less than about 25 mm. 
In a preferred embodiment, as described above, the handle has a pivotable 
tongue on its distal end, and the connection means comprises an aperture 
for receiving the tongue. The aperture has an open proximal end through 
which the tongue is received in a direction parallel to the connection 
axis. Alternatively, the connection means may comprise a threaded hole, 
snap fitting, luer fitting, threaded shaft, or tongue configured to 
connect to a complementary connector on the handle. Preferably, the 
connection means is removable from the handle to allow valve sizers, 
annuloplasty rings, and replacement valves to be interchanged on the same 
handle. However, the handle and holder may alternatively be permanently 
inseparably interconnected for dedicated use with a single annuloplasty 
device or replacement valve. 
A further understanding of the nature and advantages of the invention may 
be realized by reference to the remaining portions of the specification 
and the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
The present invention provides various devices and systems for 
less-invasive surgical treatment of cardiac valves, and methods of using 
the devices and systems. The systems may be adapted either for cardiac 
valve repair, wherein a prosthetic annuloplasty ring is attached to an 
internal wall of the heart around the native valve annulus, or for cardiac 
valve replacement, wherein the native valve is replaced with a replacement 
valve, usually a prosthetic valve. The system includes, as described in 
detail below, a delivery handle for positioning the repair or replacement 
prosthesis through an intercostal space and into the interior of the 
heart, and a prosthesis holder, preferably attached to the end of the 
delivery handle, for releasably holding the repair or replacement 
prosthesis. In various embodiments, the system may include the repair or 
replacement prosthesis itself, devices for sizing the native valve, 
devices for retracting tissue within an intercostal space to facilitate 
introduction of the prosthesis, devices for organizing the sutures used to 
attach the prosthesis within the heart, and other components. Each of 
these components will now be described, followed by a description of a 
preferred method of using the system in a patient. 
The system and method of the invention facilitate repairing or replacing a 
cardiac valve without requiring a median sternotomy or other gross 
thoracotomy, and without the substantial retraction of the ribs common in 
conventional open-chest valve treatment procedures. To accomplish this, 
the system is configured to operate through "intercostal ports," which, as 
discussed above, is used herein to include small incisions, punctures, or 
other types of percutaneous penetrations positioned in the intercostal 
spaces of the rib cage with the ribs in their natural, substantially 
unretracted positions. Cannulae, trocars, or other types of tissue 
retraction devices may be positioned in the percutaneous penetrations to 
facilitate introduction of instruments, visualization devices, prostheses, 
and the like, but these will generally be limited in size to the width of 
the intercostal space (e.g. less than about 30 mm), and will not require 
retraction of the ribs. In some cases, a slightly oversized cannula or 
retractor may be used, but even in these cases retraction of the ribs will 
be limited to less than about one centimeter. In this way, the pain, 
trauma, and complications associated with rib removal and/or gross rib 
retraction may be eliminated. 
FIGS. 1-4 illustrate a delivery handle for delivering a prosthesis mounted 
on a holder through an intercostal space and into the interior of the 
heart. As shown in FIG. 1, delivery handle 10 comprises a shaft 20 having 
a distal end 22 and a proximal end 24. A holder coupling 26 is mounted to 
distal end 22, and a handle 28 is mounted to proximal end 24. A slidable 
actuation button 30 is mounted to handle 28 and is linked to holder 
coupling 26 as described below, so that moving actuation button 30 pivots 
holder coupling 26. 
As shown in FIG. 2, in a preferred embodiment, holder coupling 26 comprises 
a base 32 mounted to distal end 22 of shaft 20. A bifurcated tongue 34 is 
pivotably mounted to base 32 by a transverse pin 36. A rod 35 extends 
through a lumen 37 in shaft 20 and is pinned to tongue 34 by a second 
transverse pin 39. A leaf spring 38 has a proximal crosspiece 40 attached 
to tongue 34, and a free distal end 42 to which is attached a catch 44 
stepped outwardly and upwardly from leaf spring 38 to define a 
proximally-facing surface 46. Catch 44 serves to retain a prosthesis 
holder on holder coupling 26, as described below. 
Shaft 20 and holder coupling 26 are configured for positioning through an 
intercostal port into the chest cavity (without retracting the ribs), and 
preferably have a cross-sectional of width less than about 30 mm. In an 
exemplary embodiment, shaft 20 is about 4-8 mm in diameter, and tongue 34 
has a transverse width of about 4-6 mm and a transverse height of about 
0.5-2.0 mm. Shaft 20 has a length selected so that holder coupling 26 may 
be positioned within the heart near the native valve to be repaired or 
replaced, with shaft 22 extending through the desired intercostal port and 
handle 28 disposed outside of the patient's chest. In a preferred 
embodiment, shaft 20 is configured to reach the mitral valve, disposed 
between the left atrium and left ventricle of the heart, from an 
intercostal port in the right lateral side of the patient's chest between 
the second and sixth intercostal spaces. For most cases, shaft 20 has a 
length of at least about 20 cm, and preferably at least about 30 cm, but 
may vary according to patient size and according to the valve to be 
repaired and the approach taken to access the valve. Shaft 20, handle 28, 
and holder coupling 26 are preferably made of stainless steel, titanium, 
aluminum, or a stiff biocompatible polymer. 
Referring now to FIGS. 3-4, rod 35 extends proximally from holder coupling 
26 through lumen 37 of shaft 20 into the interior 50 of handle 28, where 
it is attached to a lower portion of actuator button 30. Rod 35 is thus 
axially movable in tandem with actuator button 30. A lock button 52 is 
slidably mounted within a bore 54 in actuator button 30 and is biased 
upward by a coil spring (not illustrated). Lock button 52 includes an 
annular flange 56 having a tapered upper edge which engages an inner 
surface 58 of handle 28, holding lock button 52 in a downward position 
when actuator button 30 is in the proximal position of FIG. 3. When 
actuator button 30 is slid distally to the position of FIG. 4, flange 56 
is aligned with an aperture 59, allowing lock button 52 to be urged 
upward. In this position, actuator button 30 is prevented from moving 
proximally due to the engagement of flange 56 with a proximal surface 60 
of aperture 59 (best seen in FIG. 3). When it is desired to return 
actuator button 30 to the proximal position, lock button 52 is pushed 
downward until flange 56 clears proximal surface 60, allowing actuator 
button 30 to slide proximally. It should be noted that various types of 
actuators may be used for translating rod 35, such as levers, rotatable 
knobs, and push buttons. Moreover, the provision of lock button 52 is 
optional, and in some cases it may be more desirable to eliminate lock 
button 52 so that actuator button 30 is free to move distally and 
proximally without locking. Lock button 52 could also be configured to 
lock actuator button 30 in both the proximal and distal positions, or in 
various intermediate positions. 
When actuator button 30 is in the proximal position of FIG. 3, holder 
coupling 26 is preferably longitudinally aligned with the longitudinal 
axis of shaft 20. In this position, holder coupling 26 and shaft 20 have a 
transverse profile small enough that a prosthetic annuloplasty ring or 
valve on a holder, when mounted to holder coupling 26 as described below, 
may be positioned through an intercostal port into the chest cavity. 
Depending upon patient anatomy, patient size, prosthesis holder 
configuration, and prosthesis size, holder coupling 26 could be oriented 
at a range of angles between about 0.degree. and 45.degree. relative to 
the longitudinal axis of shaft 20 and still allow the prosthesis and 
holder to introduced through an intercostal port without significant 
retraction of the ribs. 
When rod 35 is translated distally by moving actuator button 30, holder 
coupling 26 pivots about pin 36 through an angle .theta. relative to the 
longitudinal axis of shaft 20, as shown in FIG. 4. In order to orient a 
prosthetic annuloplasty ring or valve optimally for attachment within the 
heart, angle .theta. is preferably about 90.degree., however, angle 
.theta. may be any angle between about 45.degree. and 135.degree., 
depending upon the particular valve being repaired or replaced, the 
location and size of the intercostal port through which delivery handle 10 
is introduced, and the anatomy of the patient. 
A cleaning port 62 is disposed in shaft 20 in communication with inner 
lumen 37 to facilitate delivery of a cleaning fluid into the interior 50 
of shaft 20 and handle 28. A plurality of drain holes 64 are provided in 
the lower side of handle 28 to allow cleaning fluid to drain from the 
handle. 
Holder coupling 26 is adapted for attachment to a valve sizing device or to 
a holder for a prosthetic annuloplasty ring or replacement valve. An 
exemplary embodiment of a holder for a prosthetic annuloplasty ring 
according to the invention is illustrated in FIGS. 5A-5C. Holder 70 
includes a holder body 72 having an outer edge 74 with a shape selected to 
match that which the annuloplasty ring is to assume when secured within 
the heart, such as D-shaped, C-shaped, kidney-shaped, semicircular, oval, 
or circular. A groove or channel 76 having an upper flange 73 extends 
around outer edge 74 on the lateral side of holder body 72 and has a size 
and shape selected to receive the annuloplasty ring in order to hold the 
annuloplasty ring on holder body 72. One or more suture holes 77 extend 
through holder body 72 through which a suture may be threaded and tied 
around the annuloplasty ring to secure it to the holder. A groove or ridge 
75 extends across top surface 78 transverse to the direction in which the 
retention sutures would be tied to holder 70. In this way, a knife may be 
guided by groove or ridge 75 to cut the sutures to release the ring from 
holder 70. Holder body 72 has a top surface 78 on which is disposed a 
handle coupling 80. In an exemplary embodiment, handle coupling 80 
comprises a slot 82 configured to receive holder coupling 26 on delivery 
handle 10. Slot 82 has an open proximal end 84 and an open distal end 86. 
Holder coupling 26 is received into slot 82 through proximal end 84 and 
slides into slot 82 until catch 44 extends outside of slot 82 through 
distal end 86, as described more fully below. 
Various exemplary annuloplasty rings which may be utilized in conjunction 
with holder 70 are illustrated in FIGS. 6A, 7A, and 8A. The annuloplasty 
rings preferably comprise a flexible, stiff, or deformable support ring 
covered by a fabric or mesh suitable for suturing the annuloplasty ring to 
heart tissue. The support ring may be a biocompatible metal such as 
stainless steel or titanium or a flexible material such as silicone rubber 
or Dacron cordage, depending upon the structural and performance 
characteristics desired in the ring. The overlying fabric or mesh may be a 
polyester knit fabric, polyester velour cloth, expanded 
polytetrafluoroethylene, or other biocompatible porous material with 
sufficient structural integrity to resist tearing when a suture is passed 
through it and secured to the heart. Holder 70 may be adapted for use with 
any of the various commercially available annuloplasty rings, including 
the Carpentier-Edwards.TM. Mitral Ring, the Carpentier PhySio.TM. Ring, or 
Cosgrove.TM. Ring available from Baxter Healthcare Corp., Edwards CVS 
Div., Irvine, Calif., the Sculptor.TM. or Duran.TM. Ring available from 
Medtronic, Inc. of Minneapolis, Minn., the Puig Massana.TM. Ring available 
from Sorin Biomedica of Salaggia, Italy, or the Biflex.TM. Ring available 
from St. Jude Medical, Inc. of St. Paul, Minn. Holder 70 is configured to 
hold annuloplasty rings of various shape and size. FIG. 6B illustrates a 
holder 70' adapted for holding the D-shaped split annuloplasty ring 90' 
shown in FIG. 6A, such as the Baxter, Inc. Carpentier-Edwards Mitral Ring. 
In FIG. 6C, annuloplasty ring 90' is mounted to holder 70', which is 
attached to holder coupling 26 of delivery handle 10. FIG. 7B illustrates 
a holder 70" adapted for holding the D-shaped continuous annuloplasty ring 
of FIG. 7A, such as the Baxter Carpentier PhySio.TM. Ring, or the 
Medtronic Sculptor.TM. Ring. FIG. 7C shows annuloplasty ring 90'" mounted 
to holder 70", which is attached to holder coupling 26 of delivery handle 
10. FIG. 8B illustrates a holder 70'" adapted for holding the C-shaped 
split or open annuloplasty ring 90'" of FIG. 8A, which may be the Baxter 
Cosgrove.TM. Ring. FIG. 8C illustrates holder 70'" holding annuloplasty 
ring 90'" and mounted to holder coupling 26 of delivery handle 10. 
Annuloplasty rings of various other shapes may also be used with the 
holder of the invention, including kidney-shaped, saddle-shaped 
racetrack-shaped, semicircular, circular, and others. In some cases, the 
annuloplasty ring 90 may be flexible and may have a shape in a natural, 
unstressed condition which is different than the shape of holder 70. For 
example, a circular ring could be held by a D-shaped holder. In this way, 
the ring conforms to the shape of holder 70 and is held in the shape it 
will be in when secured within the heart. Ring 90 may also be shapable or 
malleable so that it may shaped into the shape of holder 70 and/or 
reshaped when secured within the heart. 
As shown in FIG. 6A, annuloplasty ring 90' has a transverse height RH and a 
transverse width RW. In many cases, both transverse height RH and 
transverse width RW will be larger than the width of the intercostal space 
through which they are to be introduced. When mounted to holder 70, handle 
coupling 80 is adapted to receive holder coupling 26 such that an 
annuloplasty ring 90 can be attached to delivery handle 10 and introduced 
through an intercostal port without retraction of the adjacent ribs. In a 
preferred embodiment, slot 82 is parallel to a bottom side 88 of holder 
body 72, which is generally parallel to the plane contacting the bottom 
side of the annuloplasty ring when attached to holder 70. Such a 
configuration is illustrated in FIG. 9A, which schematically illustrates 
shaft 20 of delivery handle 10 positioning holder 70, to which is mounted 
an annuloplasty ring 90, within an intercostal space I between two ribs R 
(chest wall tissue is not shown for simplification). It may be seen that, 
when holder coupling 26 is longitudinally aligned with shaft 20, the 
bottom side 88 of holder 70, along with the plane containing the bottom 
side of annuloplasty ring 90, are parallel to the longitudinal axis of 
shaft 20 Alternatively stated, the longitudinal (or axial) axis of 
annuloplasty ring 90 is perpendicular to the longitudinal axis of shaft 
20. In this configuration, holder 70, annuloplasty ring 90 and delivery 
handle 10 have a transverse profile of minimum size to facilitate 
introduction through intercostal space I. In most adult patients, 
intercostal space I will have a width W between about 20 mm and 30 mm in 
the right lateral chest at the locations suitable for approaching the 
mitral or tricuspid valve. Thus, with annuloplasty ring 90 mated to holder 
70, the transverse height H between the bottom and top sides of holder 70, 
including the diameter shaft 20, will be less than about 30 mm, and 
preferably less than about 20 mm. 
In addition to the configuration shown in FIG. 9A, handle coupling 80 of 
holder 70 may have various alternative configurations, two of which are 
shown in FIGS. 9B and 9C. In the embodiments of FIGS. 9B-9C, slot 82 is 
oriented at an angle .alpha. relative to bottom side 88 of holder body 72 
(and the plane containing the bottom of annuloplasty ring 90 and 
perpendicular to the longitudinal axis of annuloplasty ring 90. Angle 
.alpha. is selected so that holder 70, with annuloplasty ring 90 mounted 
to it, may be attached to holder coupling 26 on shaft 20 and introduced 
through intercostal space I without retracting ribs R. Angle .alpha. may 
be either positive or negative relative to slot 82 (and the longitudinal 
axis of shaft 20), and is usually within a range of -45.degree. to 
+45.degree., and preferably -20.degree. to +20.degree.. The height H of 
holder 70 perpendicular to bottom surface 88 will be substantially less 
than intercostal width W, usually less than about 25 mm, and preferably 
less than about 20 mm, so that some clearance is provided between holder 
70 and the ribs R defining the intercostal space I. Once the holder and 
annuloplasty ring are through the intercostal space, delivery handle 10 
may be manipulated and holder coupling 26 pivoted so that annuloplasty 
ring 90 is in an orientation suitable for advancement into and attachment 
within the heart, as described more fully below. 
It should be noted that in some cases intercostal width W may be 
sufficiently large and the annuloplasty ring diameter (or width across the 
ring) sufficiently small that angle .alpha. could be as great as 
90.degree.--that is, bottom surface 88 (or the plane of ring 90) could 
form a right angle relative to the longitudinal axis of shaft 20--and ring 
90 could still be positioned through the intercostal space without 
retracting the ribs significantly. However, in most cases it will be 
advantageous to orient the ring at an angle somewhat less than 90.degree. 
relative to the longitudinal axis of shaft 20 to provide maximum clearance 
relative to the adjacent ribs and to allow the ring to be introduced 
through an intercostal port of minimum size. 
FIGS. 10A-10G illustrate a further embodiment of an annuloplasty ring 
holder according to the invention. In this embodiment, holder 420 includes 
a holder body 422 having a top surface 424 and a bottom surface 426. A 
handle coupling 428 is mounted to top surface 424, and includes an axial 
slot 430 for receiving holder coupling 26 on delivery handle 10. A flange 
432 extends around the top lateral edge of holder body 422. An 
annuloplasty ring 434, which may have various shapes, stiffnesses, and 
materials, is positionable around the lateral edge of holder body 422 
abutting flange 432. A pair of ring retention leafs 436 are rotatably 
coupled to holder body 422 by a bearing 438 so as to be rotatable about an 
axis parallel to the longitudinal axis of annuloplasty ring 434. Each ring 
retention leaf 436 has a pair of apertures 440 in a top surface thereof 
for engagement by a leaf actuation instrument 442, shown in FIG. 10G. Leaf 
actuation instrument 442 has an elongated shaft 444 long enough to reach 
the native valve position in the heart from outside of the chest cavity 
(e.g. about 30 cm), and a pair of prongs 446 at its distal end for 
insertion into apertures 440 in ring retention leafs 436. A stop 448 
extends downwardly from bottom surface 426 of holder body 422 to limit the 
rotation of ring retention leafs 436 beyond the open and closed positions. 
A lip 449 extends from bottom surface 426 to help retain ring 434 against 
flange 432. In this way, ring retention leafs 436 may be placed in the 
open position of FIGS. 10E-10F for placement of annuloplasty ring 434 on 
holder 420, and, using leaf actuation instrument 442, leafs 436 may be 
rotated into the closed position of FIGS. 10A-10C to trap ring 434 between 
leafs 436 and flange 432. After annuloplasty ring 434 has been secured 
around the native valve within the heart, leaf actuation instrument 442 
may be introduced through an intercostal port and inserted into apertures 
440 to rotate ring retention leafs 436 into the open position, releasing 
ring 434 from holder 420. 
An additional embodiment of an annuloplasty ring holder according to the 
invention is shown in FIGS. 11A-11C. Holder 450 comprises a holder body 
452 having a top surface 454 and a bottom surface 456. A handle coupling 
458 is mounted to top surface 454 and includes an axial slot 460 for 
receiving holder coupling 26 on delivery handle 10. A flange 462 extends 
around the top lateral edge of holder body 452, and a groove or channel 
464 extends around the lateral side of holder body 452 on a rearward 
portion thereof. An annuloplasty device 466, which again could be of 
various shapes, stiffnesses, and materials, may be positioned around 
holder body 452 in channel 464, so as to abut flange 462. A ring retention 
leaf 468 is hingedly mounted to bottom surface 456 by a suitable coupling 
means, such as a living hinge 470 or by a pinned hinge joint, whereby ring 
retention leaf 468 may be pivoted between the open position of FIG. 11A to 
the closed position of FIGS. 11B-11C. A pair of tabs 472 extend from an 
outer edge of ring retention leaf 468 such that, when leaf 468 is in the 
closed position of FIG. 11B, ring 466 is trapped between tabs 472 and 
flange 462. Ring retention leaf 468 is retained in the closed position by 
a pair of flexible catches 474 which may be deflected toward each other by 
applying a laterally-directed force. Each catch 474 has a tapered distal 
end 476 leading proximally to a step 478. Ring retention leaf 468 has a 
central opening 480 through which catches 474 may extend when leaf 468 is 
in the closed position, and a shelf 482 for engaging steps 478 to retain 
leaf 468 in the closed position. Thus, when leaf 468 is pivoted from the 
open position to the closed position, the tapered distal ends of catches 
474 engage leaf 468 at the edge of opening 480 and are urged inwardly as 
the leaf is closed. When leaf 468 is completely closed, steps 478 clear 
shelf 482 and catches 474 spring outwardly so that steps 478 engage shelf 
478, maintaining leaf 468 in the closed position. After annuloplasty ring 
466 has been secured around the native valve in the heart, thoracoscopic 
forceps or other elongated grasping device may be introduced through an 
intercostal port and used to squeeze catches 474 together, allowing leaf 
468 to open and releasing annuloplasty ring 466 from holder 450. 
Two additional embodiments of an annuloplasty ring holder assembly 
according to the invention are illustrated in FIGS. 12A-12B. In these 
embodiments, holder assemblies 100, 101 comprise a holder 102, 103 similar 
to the holders used with commercially-available annuloplasty rings, and an 
adaptor 104, 105 for attaching holder 102 to delivery handle 10. Holder 
102,103 is in some respects similar to holder 70 of FIGS. 5A-C, with the 
exception that, in place of handle coupling 80 of holder 70, holder 
102,103 has a hole 106, as in FIG. 12A, or a post 108, as in FIG. 12B, 
adapted for attachment to a conventional handle for use in open heart 
surgery. Hole 106 and post 108 are designed to attach to such a 
conventional handle in an orientation in which at least a distal portion 
of the handle is perpendicular to the top surface 110, 111 and bottom 
surface 112, 113 of holder 102, 103 (and the plane of the annuloplasty 
ring held by the holder). The longitudinal axes of hole 106 and post 108 
are thus perpendicular to surfaces 110, 111, 112, 113. A groove or channel 
114, 115 extends around the lateral edge of each of holders 102, 103 and 
is configured to receive an annuloplasty ring. 
Adaptors 104, 105, illustrated more clearly in FIGS. 13A-C and 14A-C, 
facilitate the attachment of a conventional angioplasty ring holder to 
delivery handle 10 of the invention. Adaptor 104 includes a 
downward-extending distal fitting 116 configured for insertion into a 
handle attachment hole in a holder like holder 102 of FIG. 12A. Adaptor 
104 further includes a proximally-extending proximal fitting 118 for 
attachment to holder coupling 26 of delivery handle 10. Distal fitting 116 
comprises a cylindrical member 120 with an annular groove 122 in which an 
O-ring 124 is disposed. Cylindrical member 120 may be inserted into hole 
106 in holder 102 and is retained therein by O-ring 124. Alternatively, 
for annuloplasty ring holders having a threaded handle attachment hole, 
cylindrical member 120 may have external threads to couple to the threaded 
hole. In a preferred embodiment, proximal fitting 118 comprises a slot 126 
having an open proximal end 128 through which holder coupling 26 is 
received and an open distal end 130 through which catch 44 may extend. As 
shown in FIG. 13C, the longitudinal axis of slot 126 is preferably 
perpendicular to the longitudinal axis of cylindrical member 120. However, 
as with holder 70 described above in connection with FIGS. 10 and 11, slot 
126 may be at a variety of angles relative to cylindrical member 120 so 
long as the annuloplasty ring held on holder 102 may be positioned through 
an intercostal space without significant retraction of the adjacent ribs. 
Usually, slot 126 is between about -45.degree. and +45.degree., and 
preferably -20.degree. to +20.degree., relative to the longitudinal axis 
of cylindrical member 120. 
Referring now to FIGS. 14A-14C, adaptor 105 comprises a distal fitting 132 
and a proximal fitting 134. In this embodiment, distal fitting 132 is 
adapted to attach to post 108 on holder 103, and comprises a cylindrical 
aperture 136 for receiving post 108. Cylindrical aperture 136 may include 
an internal O-ring (not shown) or may be tapered so as to frictionally 
engage post 108. Alternatively, if post 108 is externally threaded, 
aperture 136 may include internal threads to retain post 108 therein. 
Proximal fitting 134 preferably comprises a slot 138 having an open 
proximal end 140 and an open distal end 142 so as to receive holder 
coupling 26 of delivery handle 10 as described above in connection with 
adaptor 104. Again, slot 138 is preferably perpendicular to the 
longitudinal axis of aperture 136, but it may be at various other angles 
depending upon the size and shape of holder 103 and the annuloplasty ring 
it is designed to carry. 
While only two configurations of the adaptor and holder assembly of the 
invention are shown in FIGS. 12-14, it will be understood by those of 
ordinary skill in the art that various other configurations are possible 
to adapt virtually any of the annuloplasty ring holders currently 
available for attachment to delivery handle 10 of the invention. In most 
cases, this will simply require adapting the distal fitting of the adaptor 
for the particular handle attachment means utilized on the ring holder. 
Although the foregoing embodiments of holder 70 and adaptors 104, 105 have 
been shown as having a handle coupling in the form of a slot for receiving 
tongue 34 of delivery handle 10, various other types of handle/holder 
couplings may also be utilized. Various exemplary embodiments are 
illustrated in FIGS. 15-20. In the embodiments of FIGS. 15 and 16, holder 
coupling 26 on delivery handle 10 comprises a threaded aperture 150, and 
handle coupling 80 on holder 70 comprises a threaded shank 152 which may 
be threaded into aperture 150. In FIG. 15, the longitudinal axis of 
threaded shank 152 is parallel to holder body 72, while in FIG. 16, the 
longitudinal axis of threaded shank 152 is disposed at an angle relative 
to holder body 72, preferably between -45.degree. and +45.degree.. In 
FIGS. 17 and 18, holder coupling 26 comprises a threaded shank 154, and 
handle coupling 80 comprises a threaded aperture 156. The longitudinal 
axis of threaded aperture 156 may be parallel to holder body 72 as in FIG. 
17, or at an angle similar to threaded shank 152 of FIG. 16. 
Alternatively, the longitudinal axis of threaded aperture 156 may be 
perpendicular to holder body 72 as in FIG. 18, and threaded shank 154 may 
be mounted to shaft 20 so that the longitudinal axis of threaded shank 154 
is perpendicular to shaft 20. 
In the embodiment of FIGS. 19A-B, holder coupling 26 comprises a jaw 158 
having a pair of resilient, arcuate jaw members 160 forming a C-shape. 
Handle coupling 80 comprises a cylindrical post 162 with an annular 
channel 164 formed therein which is configured to receive jaw 158. In this 
way, jaw 158 is attached to post 162 by sliding jaw members 160 around 
post 162 within annular channel 164. Jaw 158 is slightly undersized 
relative to post 162, such that jaw members 160 flex outwardly as they are 
inserted into annular channel 164 and exert an inward force on post 162 to 
maintain a tight grip thereon. 
In still another embodiment, holder coupling 26 comprises a bayonet fitting 
166 having a cylindrical body 168 and a pair of radially extending tabs 
170. Handle coupling 80 comprises a cylindrical receptacle 172 having a 
pair of helical slots 174 in its sidewall for receiving tabs 170. In this 
way, bayonet fitting 166 may be inserted into receptacle 172 and twisted 
to form a tight attachment. 
It should be understood that the above are only some of the possible 
configurations for holder coupling 26 and handle coupling 80, and should 
not be taken to limit the range of possible interconnections between 
holder 70 and delivery handle 10. In addition to those described above, 
other possible connection means include luer fittings, snap fittings, 
spring-loaded catches, magnetic attachments, movable jaws on delivery 
handle 10 for grasping holder 70, and various others. In addition, holder 
70 may be permanently and non-removably attached to delivery handle 10. 
In order to select an annuloplasty ring of the correct size for the valve 
being repaired, the native valve must be sized. Sizing disks may be used 
for this purpose. As will be described more fully below, sizing disks of 
various sizes are positioned adjacent the native valve to be repaired 
until a disk of the proper size is identified. An annuloplasty ring of a 
corresponding size is then selected for attachment around the native 
valve. A similar technique is used for sizing a native valve for 
replacement with a prosthetic valve. Advantageously, the present invention 
provides devices and methods for sizing a native valve which may be 
utilized through an intercostal port, without retraction or removal of 
ribs. FIG. 21 illustrates a preferred embodiment of a sizing disk 
according to the invention. Sizing disk 180 comprises a disk body 182 
shaped similarly to the native valve annulus and having and having an 
upper face 183 and a lower face 185. Disk body 182 is preferably a 
transparent material such as polysulfone or polycarbonate such that the 
native valve is visible when the sizing disk is positioned in front of it. 
Two or more notches 184 or other markings may be disposed along a side of 
sizing disk 180 to facilitate measuring the spacing of the native valve 
trigones or commissures. Sizing disk 180 also includes a handle coupling 
186 for attaching the sizing disk to delivery handle 10. Handle coupling 
186 comprises, in a preferred embodiment, a slot 188 having an open 
proximal end 190 and an open distal end 192. Holder coupling 26 of 
delivery handle 10 is received into slot 188 through proximal end 190 and 
catch 44 extends out of slot 188 through distal end 192. Slot 188 is 
disposed at an angle relative to disk body 182 selected to allow sizing 
disk 180 to be introduced through an intercostal space using delivery 
handle 10 without retraction or removal of ribs. Usually the longitudinal 
axis of slot 188 is between -45.degree. and +45.degree., and is preferably 
parallel to, upper and lower faces 183, 185 of disk body 182. With this 
configuration, sizing disk 180 may be attached to holder coupling 26 of 
delivery handle 10 and introduced through an intercostal port with disk 
body 182 generally parallel to the longitudinal axis of shaft 20. Once 
within the chest cavity, sizing disk 180 may be pivoted relative to shaft 
20 into a perpendicular orientation such that the disk face is parallel to 
the native valve for the measurement thereof. Of course, like holder 70, 
handle coupling 186 may have a variety of other configurations, such as 
those of handle coupling 80 described above in connection with FIGS. 
15-20. 
A second embodiment of a native valve sizer according to the invention is 
illustrated in FIG. 22. In this embodiment, sizing disk 194 may be any of 
a variety of commercially-available sizing disks for use with the 
annuloplasty rings currently used in open heart surgery. Sizing disk 194 
has a disk body 196 with an upper face 198 and a lower face 200. Two or 
more notches 202 or other markings may be provided on a side of disk body 
196 for measurement of a native valve leaflet. A hole 204 is disposed in a 
central region of disk body 196 for attachment of the sizing disk to a 
conventional handle for use in open heart surgery. An adaptor 206 is 
further provided for attaching sizing disk 194 to delivery handle 10. In a 
preferred embodiment, adaptor 206 has a configuration like adaptor 104 
described above in connection with FIGS. 12-14. Adaptor 206 has a 
cylindrical member 208 extending downwardly and configured for insertion 
into hole 204. Cylindrical member 208 may include an O-ring 210 for 
securing the cylindrical member within hole 204. Alternatively, if hole 
204 has internal threads, cylindrical member 208 may have external 
threads. Other types of interconnections may also be used, such as a 
cylindrical aperture on adaptor 206 designed to receive a post or shank on 
sizing disk 194, like that described above in connection with holder 103 
of FIG. 12B. Adaptor 206 also has a handle coupling 212, which preferably 
comprises a slot 214 for receiving holder coupling 26 of delivery handle 
10. Slot 214 is preferably perpendicular to the longitudinal axis of 
cylindrical member 208, so as to be parallel to the upper and lower faces 
198, 200 of sizing disk 194 when connected to it. Slot 214 may be disposed 
at other angles as well, so long as sizing disk 194, when connected to 
adaptor 206 and delivery handle 10, may be introduced through an 
intercostal port without removing or significantly retracting the ribs. As 
with sizing disk 180 of FIG. 21, various other handle coupling 
configurations may also be utilized on adaptor 206. 
For cases in which valve repair is inappropriate, the invention also 
provides devices and methods for sizing a native valve which is to be 
replaced with a prosthetic valve. A replacement valve sizing disk 
according to the invention is illustrated in FIG. 23. Valve sizing disk 
220 includes a disk body 222 having an upper face 224 and a lower face 
226. Disk body 222 has a shape corresponding to that of the prosthetic 
valve to be used for replacing the native valve, and is usually circular. 
A handle coupling 228 is mounted to upper face 224. Handle coupling 228 
preferably comprises a slot 230 configured to receive holder coupling 26 
of delivery handle 10. Slot 230 has an open proximal end 232 through which 
coupling member 26 is received, and an open distal end 234 through which 
catch 44 may extend. The longitudinal axis of slot 230 is preferably 
parallel to upper and lower faces 224, 226 of disk body 222, but may be at 
other angles, usually between about -45.degree. and +45.degree., so long 
as sizing disk 220, when attached to coupling means 26 of delivery handle 
10, may be introduced through an intercostal space without retraction or 
removal of ribs. A multitude of alternative configurations for handle 
coupling 228 are also possible, including those described above in 
connection with FIGS. 15-20. 
When sizing disk 220 is attached to delivery handle 10 and positioned in 
the orientation of FIG. 24A, upper and lower faces 224, 226 are parallel 
to the longitudinal axis of shaft 20, and the combined profile of sizing 
disk 220 and shaft 20 is minimized to facilitate introduction through an 
intercostal port. Once positioned within the chest cavity, sizing disk 220 
may be pivoted into the orientation of FIG. 24B, wherein faces 224, 226 
are generally perpendicular to the longitudinal axis of shaft 20. In this 
orientation, sizing disk 220 may be positioned so that lower face 226 is 
facing the native valve to allow sizing disk 220 to be pushed in and out 
of and/or positioned within the native valve annulus to compare the native 
annulus size to the sizing disk size. This process is repeated using 
sizing disks of various diameters until the proper size is determined. 
FIG. 25 illustrates an alternative embodiment of a sizing disk assembly 
according to the invention, wherein an adaptor 236 is utilized for 
attaching a conventional sizing disk 238 to delivery handle 10. Sizing 
disk 238 may be any of a variety of sizing disks currently in use in open 
heart valve replacement surgeries, and has a shape corresponding to the 
shape of the prosthetic valve to be used for the replacement. Sizing disk 
238 has a hole 240 of rectangular cross-section suitable for attachment to 
a conventional handle utilized in open heart surgery. Adaptor 236 includes 
a rectangular tongue 242 configured for insertion into hole 240. A leaf 
spring catch 244 similar to catch 44 on delivery handle 10 is provided on 
tongue 242 to retain it within hole 240. Alternatively, sizing disk 238 
may have a post or shank extending upwardly from it, in which case 
cylindrical member 242 may have an internal aperture for receiving the 
post or shank. Adaptor 236 further includes a handle coupling 246, which 
preferably comprises a slot 248 having an open proximal end 250 for 
receiving holder coupling 26, and an open distal end 252 through which 
catch 44 may extend. The longitudinal axis of slot 248 is preferably 
perpendicular to the longitudinal axis of tongue 242 so that, when adaptor 
236 is connected to sizing disk 238, the slot is generally parallel to the 
face of the sizing disk. In this way, coupling member 26 of delivery 
handle 10 may be inserted through slot 248 and sizing disk may be oriented 
so that it is parallel to the longitudinal axis of shaft 20, thereby 
having a minimum profile for introduction through an intercostal port. 
Once the native valve has been sized for replacement, delivery handle 10 of 
the invention may also be used to deliver the replacement valve into the 
heart for attachment at the native valve position, using techniques 
described in detail below. In order to facilitate introducing the 
replacement valve through an intercostal space without retracting or 
removing ribs, the invention provides a replacement valve holder having an 
extremely small profile and adapted for attachment to delivery handle 10. 
A preferred embodiment of a valve holder according to the invention is 
shown in FIGS. 26A-26C. Valve holder 260 is adapted for holding a 
mechanical bileaflet valve prosthesis as shown in FIG. 28, which may be, 
for example, a bileaflet mitral or aortic valve prosthesis available from 
St. Jude Medical, Inc. of St. Paul, Minn., CarboMedics, Inc. of Austin, 
Tex., or Sorin Biomedica of Saluggia, Italy. In the example of FIG. 28, 
valve prosthesis 262 has an annular frame 264 and a sewing ring 266 
attached to frame 264 for attachment to an interior wall of the heart at 
the native valve position. Sewing ring 266 is covered by a fabric or mesh 
of e.g. Dacron to allow the prosthesis to be sutured to the heart tissue. 
A pair of parallel uprights 268 extend axially upward from frame 264. A 
pair of leaflets 270 having curved outer edges 272 and straight inner 
edges 274 are pivotably mounted to uprights 268. Leaflets 270 are movable 
between a closed position, in which straight inner edges 274 are 
contacting each other and curved outer edges are contacting the inner wall 
of annular frame 264, and an open position in which leaflets are spaced 
apart from each other and from annular frame 264. Frame 264, uprights 268 
and leaflets 270 are made of a rigid biocompatible polymer, metal or 
graphite coated with a thrombolytic material such as pyrolytic carbon. 
Referring again to FIGS. 26A-26C, valve holder 260 comprises a distal piece 
276 and a proximal piece 278 pivotably coupled together by two transverse 
pins 280, allowing distal piece 276 to pivot about a transverse axis 
relative to proximal piece 278, as shown in FIG. 27. Distal piece 276 has 
a top portion 282 which is bifurcated into two parallel side sections 
282A, 282B. Proximal piece 278 has a single top portion 284 disposed 
between side sections 282A, 282B. Pins 280 extend through side sections 
282A, 282B and into top portion 284. An axial slot 286 extends through top 
portion 284 in an axial direction, and is configured to receive holder 
coupling 26 on delivery handle 10. Axial slot 286 has an open proximal end 
288 through which tongue 34 is inserted and an open distal end 290 through 
which catch 44 may extend. A pair of transverse suture holes 287, 289 
extend through sides sections 282A, 282B and through top portion 284 for 
tying a retention suture, as described below. Distal piece 276 has a 
distal leg 292 extending downwardly from top portion 282 and having a 
distally-facing annular channel 294 for receiving a portion of annular 
frame 264 of valve prosthesis 262. Proximal piece 278 has a proximal leg 
296 extending downwardly from top portion 284 and having a 
proximally-facing annular channel 298 for receiving a portion of annular 
frame 264. When legs 292, 296 are pivoted into the position of FIG. 27, 
valve prosthesis 262 may be positioned over the legs, which are disposed 
between each valve leaflet 270 and annular frame 264. Legs 292, 296 may 
then be pivoted outwardly to seat annular frame 264 in channels 294, 298, 
as shown in FIG. 29. A suture 300 may then be tied through suture holes 
287, 289 to maintain distal piece 276 and proximal piece 278 in an outward 
position to retain valve prosthesis 262 thereon. 
FIGS. 30A-30B illustrate valve prosthesis 262 mounted to holder 260, which 
is attached to holder coupling 26 of delivery handle 10. In the 
introduction position of FIG. 30A, holder coupling 26 is aligned with the 
longitudinal axis of shaft 20, such that the plane containing the lower 
surface of sewing ring 266 is generally parallel to the longitudinal axis 
of shaft 20. Alternatively stated, the central longitudinal axis of valve 
prosthesis 262 is generally perpendicular to the longitudinal axis of 
shaft 20. In this position, the overall height H of holder 260, valve 
prosthesis 262, and shaft 20 is minimized to facilitate introduction 
through an intercostal port, with height H usually being less than about 
30 mm and preferably less than about 25 mm. Of course, some deviation from 
this orientation may be possible without hindering introduction through 
the intercostal port. For example, depending upon the size of the valve 
prosthesis relative to the width of the intercostal space, valve 
prosthesis 286 may be positioned as much as about +/-45.degree. from the 
position of FIG. 30A during introduction. Once valve prosthesis 262 has 
been introduced through the intercostal port, it may be pivoted into an 
orientation suitable for attachment at the native valve position within 
the heart. In the attachment orientation, the central longitudinal axis of 
valve prosthesis 262 will preferably be parallel to the longitudinal axis 
of shaft 20, such that the lower surface of sewing ring 266 is facing and 
parallel to the interior wall of the heart to which the valve will be 
attached. A variety of other angular orientations may also be used where a 
nonperpendicular approach to the valve has been taken, or in other 
appropriate circumstances. Advantageously, delivery handle 10 allows the 
valve prosthesis to be pivoted into a wide range of angular orientations 
according to the needs of each particular case. 
FIG. 30A also illustrates an important advantage of holder 260 of the 
invention. It may be seen that distal leg 292 and proximal leg 296 extend 
below the lower ends of valve leaflets 270. In this way, when valve 
prosthesis 262 is mounted to holder 260, leaflets 270 are protected from 
damage during introduction and placement. 
In the embodiment of FIGS. 26-30, valve holder 260 is attached to delivery 
handle 10 by means of axial slot 286 which receives holder coupling 26 on 
the handle. However, it will be understood to those of ordinary skill in 
the art that a variety of other handle attachment means may be used on the 
valve holder of the invention. Four exemplary alternative handle 
attachment means are shown in FIGS. 31-34. In FIG. 31, holder coupling 26 
on handle 10 comprises an internally-threaded aperture 302, and holder 260 
is attached to handle 10 by a threaded shank 304 extending proximally from 
proximal piece 278 which may be threaded into aperture 302. Shank 304 may 
be at a variety of angles relative to holder 260, but is preferably 
perpendicular to the longitudinal axis of the holder. In FIG. 32, a 
threaded shank 306 on holder 260 on the top of proximal piece 278 is 
generally parallel to the longitudinal axis of holder 260 for connection 
to a laterally-oriented internally-threaded aperture 308 on holder 
coupling 26. In FIG. 33, a threaded shank 310 on holder coupling 26 
couples to a threaded hole 312 in holder 260 which is perpendicular to the 
longitudinal axis of the holder. In FIG. 34, a threaded hole 314 is 
parallel to the longitudinal axis of the holder and connects to a 
laterally oriented threaded shank 316 on holder coupling 26. Various other 
handle connection mechanisms are also possible, including bayonet 
fittings, luer locks, spring-loaded catches, holder-gripping jaws on 
handle 10, and permanent, nondetachable linkages. The particular type of 
attachment means is not critical, so long as valve holder 260 may be 
connected to delivery handle 10 in an orientation which allows valve 
prosthesis 262 to be held on holder 260 and introduced through an 
intercostal port without removing or retracting the ribs. 
In addition to the bileaflet valve prosthesis illustrated in FIG. 28, the 
prosthesis holder and delivery system may also be adapted for use with a 
variety of other types of prosthetic valves, both mechanical and 
bioprosthetic. Various types of prosthetic valves useful with the 
invention are described in Jamieson, "Modem Cardiac Valve 
Devices--Bioprostheses and Mechanical Prostheses: State of the Art,"J. 
Card. Surg. 8:89-98 (1993). Mechanical valves which may be used include 
the caged-ball type such as the Starr-Edwards.TM. valve (Baxter Healthcare 
Corp., Edwards CVS Division, Irvine, Calif.), the tilting disk type such 
as the Medtronic-Hall.TM. valve (Medtronic, Inc., Minneapolis, Minn.), the 
Bjork-Shiley Monostrut.TM. valve (Shiley, Inc., Irvine, Calif.), the 
Omniscience.TM. valve (Omniscience Medical, Inc., Grove Heights, Minn.), 
as well as the bileaflet type such as the Baxter Duromedics.TM. Valve 
(Baxter Healthcare Corp., Edwards CVS Division, Irvine, Calif.), St. Jude 
valve (St. Jude Medical Inc., St. Paul, Minn.), Carbomedics valve 
(CarboMedics, Inc., Austin, Tex.), or Sorin valve (Sorin Biomedica, 
Saluggia, Italy). Bioprosthetic valves which may be placed using the 
devices and techniques of the invention include porcine aortic valves such 
as the Hancock II.TM. bioprosthesis (Medtronic, Inc., Minneapolis Minn.), 
the Carpentier-Edwards.TM. supraannular bioprosthesis (Baxter Healthcare 
Corp., Edwards CVS Division, Irvine, Calif.), the Carpentier-Edwards.TM. 
stentless bioprosthesis (Baxter Healthcare Corp., Edwards CVS Division, 
Irvine, Calif.), the St. Jude Bioimplant.TM. bioprosthesis (St. Jude 
Medical Inc., St. Paul, Minn.), or the Medtronic Intact.TM. bioprosthesis 
(Medtronic, Inc., Minneapolis, Minn.). Other valves which may be used 
include the Mitroflow.TM. bioprosthesis (Mitroflow International, Inc., 
Richmond, British Columbia, Canada), and the Carpentier-Edwards.TM. 
pericardial bioprosthesis (Baxter Healthcare Corp., Edwards CVS Division, 
Irvine, Calif.). The invention also facilitates valve replacement with 
homografts and allografts, polymeric valves, and a variety of mechanical 
and bioprosthetic valves not specifically listed here. 
The methods of repairing and replacing a diseased heart valve according to 
the invention will now be described with reference to FIGS. 35-46. The 
patient must first be prepared for surgery by inducing general anesthesia, 
establishing cardiopulmonary bypass, and inducing cardioplegic arrest. 
Devices and techniques for inducing cardioplegic and establishing 
cardiopulmonary bypass which may be used in conjunction with the method of 
the present invention are described in co-pending application Ser. Nos. 
08/282,192, filed Jul. 28, 1994, 08/159,815, filed Nov. 30, 1993, and 
08/173,899, filed Dec. 27, 1993, which are incorporated herein by 
reference. As described in those applications, after general anesthesia 
has been induced, cardiopulmonary bypass is initiated by placing a venous 
cannula in a major peripheral vein such as a femoral vein, and placing an 
arterial cannula in a major peripheral artery such a femoral artery. The 
venous and arterial cannulae are connected to a cardiopulmonary bypass 
system, which includes an oxygenator for oxygenating blood withdrawn from 
the patient through the venous cannula, a filter for removing emboli from 
the blood, and a pump for returning the blood to the patient's arterial 
system through the arterial cannula. 
With cardiopulmonary bypass established, cardioplegic arrest may be 
induced. Although conventional, open-chest external aortic cross clamping 
and aortic cannulation through the aortic wall may be utilized, 
closed-chest cardioplegia techniques are preferred. As described in the 
forementioned copending applications, cardioplegia may be induced on a 
closed-chest patient by introducing an aortic catheter into a femoral 
artery or other major peripheral artery, transluminally positioning the 
distal end of the aortic catheter in the ascending aorta, and expanding an 
expandable member such as a balloon on the distal end of the aortic 
catheter to occlude the ascending aortic lumen between the coronary ostia 
and the brachiocephalic artery. A cardioplegic agent, preferably 
comprising a potassium chloride solution mixed with blood, is then 
delivered through a lumen of the aortic catheter into the ascending aorta, 
where the cardioplegic fluid flows into the coronary arteries, perfusing 
the myocardium and arresting cardiac function. A venting catheter may also 
introduced into the right side of the heart or into the pulmonary artery 
from a peripheral vein, as described in copending application Ser. No. 
08/415,238, filed Mar. 30, 1995, which is incorporated herein by 
reference. In addition, a retrograde cardioplegia catheter may be 
introduced from another peripheral vein into the coronary sinus for 
delivering cardioplegic fluid into the coronary sinus under sufficient 
pressure to flow in a retrograde manner through the coronary veins to 
perfuse the myocardium, as described in copending application Ser. No. 
08/372,741, filed Jan. 12, 1995, which is incorporated herein by 
reference. 
As an alternative to these endovascular techniques, cardioplegic arrest may 
be induced by occluding the ascending aorta with a thoracoscopic 
cross-clamp positioned externally on the aorta through an intercostal port 
in the anterior chest. Cardioplegic fluid may then be delivered upstream 
of the clamp with a cannula intraluminally positioned in the aorta from a 
peripheral artery, or by penetrating the aortic wall with a cannula 
introduced thoracoscopically. Such techniques are described in copendig 
application Ser No. 08/173,899, filed Dec. 27, 1993, which has been 
incorporated herein by reference. 
In order to obtain access to the heart from the right lateral side of the 
chest, the right lung must be collapsed. This may be accomplished by 
inserting an endotracheal tube into the right main stem bronchus and 
applying a vacuum so as to deflate the lung. 
With cardiac function arrested and the patient's circulation supported by 
extracorporeal cardiopulmonary bypass, the patient is ready for the valve 
repair or replacement procedure. Referring to FIG. 35, a number of 
percutaneous cannulae, hereinafter referred to as "ports," are positioned 
in the anterior chest and right lateral chest to provide access into the 
chest cavity. In most cases, 3 to 5 ports are required, including a 
retraction port 332 located in the anterior chest over the right lateral 
wall of the right atrium, an oval port 334 located in the right lateral 
chest in the second, third, fourth, fifth or sixth intercostal space, and 
at least one instrument port 336 in the right lateral chest or anterior 
chest for introduction of instruments or visualization devices. Retraction 
port 332 and instrument ports 336 are configured for placement within an 
intercostal space without requiring retraction of the ribs, and are 
usually 5-12 mm in diameter. To introduce the ports, a small puncture or 
incision is made in the intercostal space at the desired location, and, 
with an obturator positioned in the lumen of the ports, they are advanced 
through the puncture or incision. 
Oval port 334, illustrated in FIG. 36A-36D, is also configured for 
placement within an intercostal space without retraction of ribs, and has 
a width of less than about 30 mm, and preferably less than about 25 mm. 
Oval port 334 has a percutaneous tube 340 having a flange 342 at its 
proximal end to engage the outside of the chest when the oval port is 
introduced. A plurality of tie-down holes 343 are provided in flange 342 
to facilitate securing oval port 334 to the patient by means of sutures or 
other tie-down means passed through holes 343. Percutaneous tube 340 has a 
length sufficient to extend from outside of the chest, through the 
intercostal space, and into the chest cavity just beyond the interior of 
the chest wall, the length typically being in the range of 30-50 mm. 
Percutaneous tube 340 has an inner lumen 338 with shape and dimensions 
selected to allow an annuloplasty ring or replacement valve on a holder to 
be introduced through it using delivery handle 10. Inner lumen 338 usually 
has a width of about 10-30 mm, and preferably 15-25 mm, and a height of 
about 25-75 mm, preferably 30-50 mm. The exact width and height will be 
determined by the width (or diameter) and height of the particular 
annuloplasty ring or replacement valve and holder being used in the 
procedure. It is usually desirable to begin the procedure with an oval 
port 334 of the minimum size necessary to assess the condition of the 
native valve and to allow introduction of valve sizing disks. For example, 
an oval port 334 having a width of about 15-.degree.mm may be used 
initially. When the size of the annuloplasty ring or prosthetic valve to 
be used has been selected, the smaller oval port may be replaced, if 
necessary, with a larger oval port to accommodate the prosthesis. 
Oval port 334 may also include a suture organizing ring 344 attached to 
flange 342 so as to surround inner lumen 338. Organizing ring 344 has a 
plurality of circumferentially-spaced radial slots 346 in which a suture 
thread may be received and retained by friction. Slots 346 have tapered 
upper ends 348 to allow a suture thread to be easily guided into the slot. 
Suture organizing ring 344 allows sutures placed in the heart for 
attachment of a prosthesis to be drawn through inner lumen 338 and 
temporarily placed in slots 346 so as to keep the sutures individually 
separated and untangled, as described more fully below. 
In order to facilitate introducing oval port 334 through a puncture or 
small incision between the ribs, an obturator 350 may be slidably inserted 
into inner lumen 338, as illustrated in FIGS. 37A-B. Obturator 350 
includes an oval shaft 352 positionable within inner lumen 338 and a 
tapered or pointed distal end 354 which extends distally of the distal end 
of percutaneous tube 340. A handle 356 is attached to the proximal end of 
oval shaft 352 and has a distal face 358 for engaging flange 342 on oval 
port 334. Handle 356 has shape and dimensions suitable for grasping in the 
hand of the user and applying a distally-directed force for percutaneous 
introduction. Once oval port 334 has been introduced through an 
intercostal space, obturator 350 is removed from inner lumen 338. 
In addition to the oval configuration shown, oval port 334 may have an 
inner lumen of various other shapes, including race-track, rectangular, 
trapezoidal, elliptical or circular. Alternatively, oval port 334 may be 
made of a flexible or deformable material to allow it to be shaped by the 
user or to conform to the shape of the intercostal space. In addition, 
other means of tissue retraction may be used in place of oval port 334, 
such as a 3-sided channel-shaped member, or a wound retractor having a 
pair of adjustable parallel blades which can be placed in an intercostal 
incision and used to create a space by widening the distance between the 
blades. All of these may fall within the scope of the invention to the 
extent they facilitate introduction of a prosthetic annuloplasty ring or 
valve through an intercostal space without significant retraction or 
removal of the ribs or sternum. 
Referring again to FIG. 35, with ports 332, 334, 336 in position, surgery 
within the chest cavity may begin. Much, if not all of the procedure may 
be carried out under direct vision by illuminating the chest cavity with a 
light source or light guide positioned in an instrument port or in the 
oval port and looking through the inner lumen of oval port 334 or through 
one of the instrument ports. Head-mounted surgical loupes specially 
designed for looking through a small incision or cannula may be utilized 
to facilitate direct vision through a port, such as the devices described 
in U.S. Pat. Nos. 4,836,188, 4,196,966, and 4,807,987, which are 
incorporated herein by reference. A fiberoptic bundle may also be attached 
to or embedded in the wall of one of instrument ports 336 or in 
percutaneous tube 340 of oval port 334 to transmit light into the chest 
from a light source outside the chest, in the manner disclosed in 
copending application Ser. No. 08/227,366, filed Apr. 13, 1994, which is 
incorporated herein by reference. In most cases, however, it will be 
desirable to introduce a thoracoscope 360 through an instrument port 336 
to provide additional illumination and visualization of the chest cavity, 
preferably by means of a video camera mounted to thoracoscope 360 which 
transmits a video image to a monitor (not shown in FIG. 35). Thoracoscope 
360 may comprise a rigid thoracoscope with a straight end or an angled end 
such as those available from, for example, Olympus Corp., Medical 
Instruments Division, Lake Success, N.Y. Alternatively, a thoracoscope 
with an articulated end steerable by means of an actuator at the proximal 
end of the device may be used, such as the Welch Allyn DistalVu.TM. 
(formerly Baxter DistalCam.TM. 360), available from Welch Allyn, Inc., of 
Skaneateles Falls, N.Y. 
Thoracoscopic surgical instruments are then introduced in order to form an 
opening in the pericardium, which surrounds the heart. If the right lung 
is not sufficiently collapsed, atraumatic retraction instruments may be 
introduced through one of the ports to push the lung posteriorly such that 
the pericardium is visible by looking through oval port 334 or through one 
of instrument ports 336. Thoracoscopic scissors 362 and graspers 364 are 
then introduced through oval port 334 or instrument port 336 and used to 
cut an opening in the pericardium P. Suitable thoracoscopic instruments 
for use in the method of the invention are described in copending 
application Ser. Nos. 08/281,962, filed Jul. 28, 1994, and Ser. No. 
08/194, 946, filed Feb. 11, 1994, which are incorporated herein by 
reference. 
With an opening formed in the pericardium, the right lateral wall of the 
left atrium is in a direct line of sight from the right lateral chest 
looking through inner lumen 338 of oval port 334. An atriotomy incision AI 
is then made in the left atrial wall W by means of thoracoscopic scissors 
362 and graspers 364 introduced through instrument ports 336 and/or 
through oval port 334, as illustrated in FIG. 38. Atriotomy AI is located 
between and just anterior to the pulmonary veins PV. 
Before making atriotomy incision AI, it may be advantageous to flood the 
thorax with cool carbon dioxide (CO.sub.2) and to maintain this CO.sub.2 
blanket around the heart throughout the procedure in order to help exclude 
air from the chest cavity and heart, thereby reducing the risk of trapped 
air embolism in the heart. In such cases, retraction port 332, oval port 
334 and instrument ports 336 may include gaseous seals like those used in 
laparoscopic trocar sleeves to prevent loss of C0.sub.2 from the chest 
cavity and/or introduction of air into the chest cavity. C0.sub.2 may be 
introduced through an insufflation tube introduced through one of these 
ports, or through an insufflation lumen extending through one of the 
ports. 
Referring to FIGS. 39-40, an endoscopic atrial retractor 366 is then 
inserted through retraction port 332, positioned in atriotomy Al, and 
pulled anteriorly so as to retract atriotomy AI open. A rake-type 
retractor with several collapsible blades 368 (best seen in FIG. 40), 
coupled to the end of an elongated handle 370 may be used for this 
purpose, as described in copending application Ser. No. 08/281,962, filed 
Jul. 28, 1994. Alternatively, a retractor having a single larger 
transverse blade which is attachable and removable from an elongated 
handle may be used, as described in copending application Ser. No. 
08/294,454, filed Aug. 23, 1994, which is incorporated herein by 
reference. The single blade may be introduced through inner lumen 338 of 
oval port 334 while the handle is introduced through retraction port 332, 
the blade then being attached to the handle within the chest cavity, and 
positioned within atriotomy AI to facilitate retraction. With atriotomy AI 
retracted, direct visualization of mitral valve MV is possible through 
inner lumen 338 of oval port 334, as shown in FIG. 40. 
Under either direct visualization through a port or video-based viewing 
using thoracoscope 360, the condition of mitral valve MV is then assessed 
to determine whether the valve may be repaired, or whether replacement of 
the valve is necessary. If the surgeon determines that repair is the more 
suitable option, a number of repair procedures may be performed, including 
annuloplasty, wherein an annuloplasty ring is attached around the native 
valve to contract the annulus, quadrangular resection, in which a portion 
of a valve leaflet is excised and the remaining portions of the leaflet 
are sewn back together, commissurotomy, wherein the valve commissures are 
incised to separate the valve leaflets, shortening of the chordae 
tendonae, reattachment of severed chordae tendonae or papillary muscle 
tissue, and decalcification of the valve leaflets or annulus. Several of 
these procedures may also be performed on the same valve. In particular, 
annuloplasty rings may be used in conjunction with any repair procedures 
where contracting or stabilizing the valve annulus might be desirable. 
In a preferred method of annuloplasty according to the invention, a 
prosthetic annuloplasty ring is introduced through oval port 334 and 
attached to an interior wall of the heart around the native valve annulus 
VA of mitral valve MV. In order to select an annuloplasty ring of the 
proper size, the native valve must be measured using a sizing device such 
as sizing disk 180 or 194 described above in connection with FIGS. 21-22. 
As illustrated in FIG. 39, sizing disk 180 is attached to coupling member 
26 on the distal end of delivery handle 10, and pivoted relative to shaft 
20 into an orientation appropriate for introduction through inner lumen 
338 of oval port 334. Preferably, in this orientation, the lower face 185 
of sizing disk 180 will be generally parallel to the longitudinal axis of 
shaft 20. Sizing disk 180 is then introduced through oval port 334 and 
through atriotomy AI using delivery handle 10, until the sizing disk is 
within the left atrium LA. Sizing disk 180 is then pivoted using actuator 
button 30 on handle 28 such that lower face 185 is facing mitral valve MV, 
approximately perpendicular to the longitudinal axis of shaft 20. Under 
visualization with thoracoscope 360 and/or direct vision through a port, 
sizing disk 180 is positioned adjacent or against mitral valve MV and the 
size of the native valve is measured, usually by measuring the width of 
the anterior leaflet AL (FIG. 40) by comparing the width of sizing disk 
180, and by measuring the spacing between the native valve commissures or 
trigones using notches 184 or other markings on sizing disk 180. Sizing 
disks of various sizes may be interchanged on delivery handle 10 and 
positioned adjacent mitral valve MV until the proper size has been 
determined. 
With an annuloplasty ring of the appropriate size identified, sutures are 
placed in or just outside of the native valve annulus VA, as illustrated 
in FIG. 40. Double-armed sutures 372 of braided polyester or Nylon and 
having a length of about 30-36 cm are preferred. Thoracoscopic needle 
drivers 374 may be used to grasp a curved suture needle 376 on one end of 
a suture 372, position the suture in left atrium LA through oval port 334 
or an instrument port 336, and drive needle 374 through valve annulus VA 
in the manner shown in FIG. 40. Appropriate thoracoscopic needle drivers 
are described in copending application Ser. Nos. 08/281,962, filed Jul. 
28, 1994, and Ser. No. 08/194, 946, filed Feb. 11, 1994, which have been 
incorporated herein by reference. Suture placement is visualized either by 
direct vision through oval port 334 or by using thoracoscope 360. Usually 
between 8 and 20 double-armed sutures 372 are placed in valve annulus VA. 
After being placed, suture needles 376 are drawn out of the chest cavity 
through inner lumen 338 of oval port 334, and sutures 372 are inserted 
into slots 346 in organizing ring 344. 
Sutures 372 are next placed through annuloplasty ring 90 on holder 70, as 
illustrated in FIG. 41. Holder 70 is attached to holder coupling 26 on 
delivery handle 10, which optionally may be held in a clamping fixture 380 
attached to the operating table 382. Each suture needle 376 is grasped in 
a needle driver 374 and passed through annuloplasty ring 90. Sutures 372 
may then be placed in a suture organizer, or a pair of hemostats (not 
shown) may be clamped onto each needle 376 and suspended from annuloplasty 
ring 90 to maintain tension on the sutures and prevent tangling. 
Annuloplasty ring 90 is then introduced through inner lumen 338 of oval 
port 334, as illustrated in FIG. 42. Holder 70 is pivoted relative to 
shaft 20 so that annuloplasty ring 90 will pass through inner lumen 338 
without interference, preferably in an orientation in which a plane 
containing the lower surface of annuloplasty ring 90 is parallel to the 
longitudinal axis of shaft 20. As annuloplasty ring 90 is advanced into 
the left atrium LA, tension is maintained on sutures 372 by organizer ring 
344 or by individual hemostats (not pictured) clamped onto each pair of 
needles 376 on sutures 372 so that the annuloplasty ring slides along the 
sutures up to the mitral valve MV. Once through oval port 334 and into the 
chest cavity, actuator button 30 on delivery handle 10 may be actuated so 
that annuloplasty ring 90 pivots into an orientation suitable for 
attachment within the left atrium LA, preferably in an orientation in 
which the lower surface of the annuloplasty ring is parallel to the mitral 
valve and perpendicular to the longitudinal axis of shaft 20. Annuloplasty 
ring 90 is positioned in contact with the interior wall of the left atrium 
in which sutures 372 have been placed so as to surround the native valve 
annulus VA. 
Holder 70 may then be removed from annuloplasty ring 90 by cutting any 
sutures used to retain ring 90 on the holder, and urging ring 90 out of 
channel 76 on the side of holder 70. Holder 70 and delivery handle 10 may 
then be removed from the chest cavity. 
Needles 376 are then trimmed from each suture 372, and, as illustrated in 
FIGS. 43-44, knots 384 are tied in each suture 372 and pushed into left 
atrium LA and against annuloplasty ring 90 by an endoscopic knot pusher 
386. Knot pusher 386 preferably comprises a knot pusher with a rounded 
distal end 388 and a single lateral eyelet 390, as disclosed in copending 
application Ser. No. 08/288,674, filed Aug. 10, 1994, which is 
incorporated herein by reference. This knot pusher is particularly 
well-adapted for the method of the invention due its long length and low 
profile, and due to the quickness with which knots can be tied and the 
ease with which they can be slid into the left atrium from outside of the 
chest cavity. After each suture 372 is tied securely against annuloplasty 
ring 90, the suture ends are trimmed off using thoracoscopic scissors 362. 
If neither annuloplasty nor any other repair procedure will adequately 
treat the diseased valve, the surgeon may elect to replace the native 
valve with a replacement valve. The techniques for introducing and 
securing a replacement valve within the heart will be analogous to those 
described above for annuloplasty ring 90, and are further described in 
copending application Ser No. 08/281,962, filed Jul. 28, 1994, which has 
been incorporated herein by reference. The native valve may be sized for 
replacement using valve sizing disks 220 or 238, shown in FIGS. 23-25, 
which are introduced into left atrium LA using delivery handle 10 by 
techniques similar to those described above for sizing mitral valve MV for 
an annuloplasty ring. Once a prosthetic valve 262 of the appropriate size 
is identified, thoracoscopic needle drivers 274 may be used to place 
sutures around the native valve annulus, in much the same way as described 
above for annuloplasty ring 90, using a mattress stitch or everted 
mattress stitch. As in the case of annuloplasty, the sutures are withdrawn 
from the body cavity through inner lumen 338 of oval port 334 and placed 
in slots 346 of organizing ring 344. Each suture is then placed through 
sewing ring 266 of prosthetic valve 262 outside of the chest cavity. 
Optionally, prior to suture placement, the valve leaflets of the native 
valve may be removed using thoracoscopic scissors 362. 
Prosthetic valve 262, held on valve holder 260 (described above in 
connection with FIGS. 26-34), is then attached to delivery handle 10 to 
facilitate delivery of the replacement valve through oval port 334 into 
left atrium LA. During introduction, prosthetic valve 262 is pivoted into 
an orientation in which it will pass through inner lumen 338 of oval port 
334 without interference, preferably with the longitudinal axis of sewing 
ring 266 approximately perpendicular to the longitudinal axis of shaft 20 
as shown in FIG. 30A. Once within the chest cavity, prosthetic valve 262 
is pivoted into an orientation suitable for attachment at the native valve 
position in the heart, preferably with the longitudinal axis of sewing 
ring 266 perpendicular to the interior wall of the heart to which the 
valve will be attached, and parallel to the longitudinal axis of shaft 20 
as shown in FIG. 30B. Prosthetic valve 262 may then be removed from holder 
260 by cutting retaining suture 300, and holder 260 and delivery handle 10 
are removed from the chest cavity. 
It may be necessary to seat the prosthetic valve firmly against the native 
valve annulus after holder 260 and delivery handle 10 have been removed. A 
valve seater 400, illustrated in FIG. 45A, may be utilized for this 
purpose. Valve seater 400 comprises an elongated rigid shaft 402, and a 
valve engaging tip 404 at its distal end. Valve engaging tip 404 has a 
concave end 406 radiused so as to match sewing ring 266, and is made of a 
soft polymer such as silicone rubber or thermoplastic elastomer (TPE) with 
a durometer in a range of 20 to 70 Shore A so that it can contact the 
prosthetic valve without damaging it. Valve seater 400 has a length of at 
least about 20 cm and usually at least 30 cm so as to reach the mitral 
position from outside the chest cavity via an intercostal port, and a 
diameter of less than about 25 mm, usually less than about 8 mm, so as to 
be positionable through an intercostal port. In this way, valve seater 400 
may be positioned through an intercostal port (e.g. oval port 334) and tip 
404 can be used to push against sewing ring 266 to seat the prosthetic 
valve against the native valve annulus. 
Knots are then formed in the sutures and pushed into the left atrium using 
thoracoscopic knot pusher 386. The sutures are then trimmed off above the 
knot using thoracoscopic scissors 362, as described above. 
Before or after the prosthetic valve has been secured in the heart, it may 
be necessary to test its leaflets to ensure they are functioning properly. 
A leaflet testing device as illustrated in FIG. 45B may be used for this 
purpose. Leaflet testing device 408 comprises a rigid shaft 410 and a 
leaflet-engaging tip 412 attached to the distal end of shaft 410. Shaft 
410 has a length of at least about 20 cm usually at least 30 cm, and a 
diameter of less than about 25 mm, usually less than about 8 mm, to reach 
the mitral position from outside the chest via a right lateral intercostal 
port. Tip 412 has a tapered distal end 414 configured to push lightly on 
each valve leaflet 270 (FIG. 28) to fully open the leaflet without 
interference with annular frame 264. Because valve leaflets 270 may be 
fragile and susceptible to damage, tip 412 is made of a soft polymer such 
as silicone rubber or thermoplastic elastomer (TPE) with a durometer in a 
range of 20 to 70 Shore A. In this way, leaflet testing device 408 may be 
introduced through oval port 334 and each leaflet of the valve prosthesis 
pushed gently distally to ensure the leaflets are opening properly. 
For certain types of heart valves prostheses, it may also be desirable to 
rotate the annular frame and valve leaflets relative to the sewing ring 
after the prosthesis has been secured in the heart. For this purpose, a 
specially designed valve rotator may be used. The valve rotator has an 
atraumatic rotator head for engaging the valve frame and/or leaflets 
similar to that disclosed in U.S. Pat. No. 5,403,305, which is 
incorporated herein by reference. However, rather than a socket which 
connects the head to a handle such that the face of the head is 
perpendicular to the handle, the rotator head used in the method of the 
present invention has a handle coupling like handle coupling 80 of FIGS. 
5A-5C. In this way the rotator head may be connected to holder coupling 26 
of delivery handle 10 so that it may be positioned in an edge-first 
orientation for introduction through an intercostal port, then pivoted 
into a face-first orientation for rotating the valve prosthesis. 
When annuloplasty ring 90 or replacement valve 262 has been secured within 
the heart, atriotomy AI may be closed, as illustrated in FIG. 46. 
Thoracoscopic needle drivers 374 may be used to grasp a curved needle 392 
on a suture 394, introduce suture 394 into the chest cavity through oval 
port 334 or an instrument port 336, and drive needle 392 through the left 
atrial wall to create a series of stitches across atriotomy AI. 
Alternatively, an endoscopic stapling device such as an AutoSuture.TM. 
Powered Multifire Endo TA60, available from United States Surgical Corp. 
of Norwalk, Conn., or an endoscopic fascia stapler, may be inserted 
through an anterior instrument port 336 and positioned around atriotomy AI 
to drive a series of staples into the atrial wall to close the atriotomy. 
The opening formed in the pericardium may be closed with sutures or staples 
in a manner similar to that used for closing atriotomy AI. However, in 
most cases, closure of the pericardium is not necessary, and the opening 
may be left in it without adverse effect. 
To complete the operation, cardiac function is restored by discontinuing 
delivery of cardioplegic fluid, terminating occlusion of the ascending 
aortic lumen, and perfusing the myocardium with warm blood. Preferably, 
where an aortic catheter has been used for aortic occlusion and 
cardioplegic fluid delivery, the expandable member on the distal end of 
the aortic catheter is deflated and warm blood is allowed to flow into the 
coronary arteries. If sinus rhythm is does not return immediately, 
electrical defibrillation may be used to stimulate the heart and/or pacing 
leads may be placed through a port into the heart muscle to pace the heart 
for a period of time postoperatively. Once the heart is beating normally, 
the aortic catheter may be removed from the patient, along with any 
venting catheter or retrograde cardioplegia delivery catheter which may 
have been used. Chest tubes may be inserted into the chest to provide 
drainage. The patient is then weaned from cardiopulmonary bypass, and the 
arterial and venous cannulae are removed from the patient. All venous and 
arterial punctures or cut-downs are closed. Any endotracheal tubes used 
for ventilation are removed. Retraction port 332, oval port 334, and 
instrument ports 336 are removed from the chest, and all intercostal 
incisions and punctures are closed. The patient is then recovered from 
anesthesia. 
It will be understood to those of ordinary skill in the art that, while the 
invention has been described specifically in the context of mitral valve 
repair and replacement, the devices and methods disclosed herein will have 
equal application to a number of other cardiac valves, including the 
aortic valve, the tricuspid valve, and the pulmonary valve. While the 
specific locations of these valves and the surgical approaches utilized to 
access these valves may differ from those described in detail above, the 
devices and methods described herein are easily adapted for use on valves 
other than the mitral without departing from the scope of the invention. 
For example, the tricuspid or pulmonary valves may be accessed similarly 
to the mitral valve through an intercostal port in the right lateral chest 
to access the right atrium (for the tricuspid valve) or the right 
ventricle (for the pulmonary valve), on the other hand, the aortic valve 
can be accessed from an intercostal port in the upper anterior chest via 
an incision in the ascending aorta. Moreover, although the devices and 
methods of the invention have been described in connection with specific 
types of prosthetic annuloplasty rings and replacement valves, these are 
given by way of example only. It should be understood that a wide variety 
of prostheses may be implanted using the devices and methods of the 
invention with little if any modification to the specific embodiments 
described above. 
Using the devices and methods of the invention, a cardiac valve may be 
repaired or replaced using minimally-invasive techniques which eliminate 
the need for a median sternotomy or other gross thoracotomy involving 
cutting, removal, or substantial retraction of the ribs or sternum. As a 
result, patient recovery is accelerated, pain and trauma are greatly 
reduced, and the morbidity and mortality of valve repair and replacement 
procedures may be decreased. Not only may this result in better outcomes 
and reduced costs for the thousands of patients who undergo cardiac valve 
surgery each year, but may allow thousands more suffering from valve 
disease to receive surgical treatment who would otherwise be unable or 
unwilling to tolerate the pain and trauma of open-heart valve surgery. 
While the above is a complete description of the preferred embodiments of 
the invention, various alternatives, modifications, additions, and 
substitutions are possible without departing from the scope thereof. 
Therefore, the above should not be taken as limiting the scope of the 
invention, which is defined by the following claims.