Bifurcated connector system for coronary bypass grafts and methods of use

A system and method of use for effecting the bypass or other anastomosis of a portion of a native blood vessel, duct, lumen or other tubular organ within the body of a living being. The system includes a connector assembly and a deployment instrument for carrying the device to the desired position within the vessel, duct, lumen or tubular organ. The system includes a piercer-dilator instrument to form an opening in the wall of the vessel, duct, lumen or tubular organ into which the connector assembly is deployed by the deployment instrument. The connector assembly is at least partially formed of a resorbable material and includes movable members for securing it to the tissue of the vessel, duct, lumen or tubular organ contiguous with the opening. Other components may be included in the device for expediting the anastomosis procedure, with or without the use of sutures. Moreover, the system can be used to bypass of at least two coronary arteries by a common connection with the aorta utilizing at least two bypass grafts, a single upstream anastomosis connector, a pair of downstream anastomosis connectors, and a common bifurcated midstream anastomosis connector, for securement between the aorta and the coronary arteries.

BACKGROUND OF THE INVENTION 
This invention relates generally to medical devices and methods of 
performing surgical procedures and more particularly to the anastomosis of 
blood vessels, ducts, lumens or other tubular organs. 
Arterial bypass surgery is a common modality for the treatment of occlusive 
vascular disease. Such surgery typically involves a formal surgical 
incision and exposure of the occluded vessel followed by the joinder of a 
graft, e.g., a mammary artery, saphenous vein, or synthetic graft (all 
collectively referred to hereinafter as the "bypass graft"), to the 
occluded vessel(hereinafter the "native" blood vessel) distally 
(downstream) of the occlusion. The upstream or proximal end of the bypass 
graft is secured to a suitable blood vessel upstream of the occlusion, 
e.g., the aorta, to divert the flow of blood around the blockage. Other 
occluded or diseased blood vessels, such as the carotid artery, may be 
similarly treated. Moreover, similar procedures are conducted to place a 
graft between an artery and a vein in dialysis patients. 
While such surgical procedures are widely practiced they have certain 
inherent operative limitations. For example, sewing the graft to the host 
vessel, known as anastomosis, requires complex and delicate surgical 
techniques to accomplish the optimum result. Various complications must be 
avoided when anastomosing a bypass graft, whether it be a natural graft or 
a synthetic graft. For example, it is important that the juncture between 
the native vessel and the bypass graft form a smooth uniform transition 
without narrowing or regional irregularities which could tend to reduce 
blood flow. Moreover, any protuberances into the lumen could obstruct 
blood flow and may produce turbulence, thereby increasing the risk of 
clotting and/or restenosis. In addition, the difference in size between 
the typically larger internal diameter of the bypass graft and the 
typically smaller native artery may also produce unwanted turbulence in 
the blood. All of these characteristics can greatly diminish the 
effectiveness and patency of the graft. 
Various devices and methods of use have been disclosed for effecting 
anastomosis of blood or other vessels, ducts, lumens or other tubular 
organs. Examples of such devices and methods are found in U.S. Pat. Nos. 
2,127,903 (Bowen), 3,155,095 (Brown), 3,588,920 (Wesolowski), 3,620,218 
(Schmitt et al.), 3,683,926 (Suzuki), 4,214,586 (Mericle), 4,233,981 
(Schomacher), 4,366,819 (Kasler), 4,368,736 (Kasler), 4,470,415 (Wozniak), 
4,501,263 (Harbuck), 4,675,008 (Tretbar), 4,512,761 (Raible), 4,552,148 
(Hardy, Jr. et al.), 4,721,109 (Healy), 4,753,236 (Healy), 4,769,029 
(Patel), 4,851,001 (Taheri), 4,816,028 (Kapadia et al.), 4,854,318 (Solem 
et al.), 4,930,502 (Chen), 4,931,057 (Cummings et al.), 4,957,499 (Lipatov 
et al.), 5,156,619 (Ehrenfeld), 5,123,908 (Chen), 5,192,289 (Jessen), 
5,250,058 (Miller), 5,222,963 (Brinkerhoff et al.), 5,330,490 (Wilk et 
al.), 5,346,501 (Regula et al.), 5,364,389 (Anderson), 5,399,352 (Hanson), 
5,425,738 (Gustafson et al.), 5,425,739 (Jessen), 5,443,497 (Venbrux), 
5,445,644 (Pietrafitta et al.), 5,447,514 (Gerry et al.), 5,456,712 
(Maginot), 5,456,714 (Owen), 5,503,635 (Sauer et al.), 5,509,902 
(Raulerson), 5,571,167 (Maginot), 5,586,987 (Fahy) and 5,591,226 
(Trerotola et al.). 
In our copending U.S. patent application Ser. No. 08/861,584 filed on May 
22, 1997 entitled Anastomosis System And Method of Use, which is assigned 
to the same assignee as this invention and whose disclosure is 
incorporated by reference herein (hereinafter the "'584 application"), 
there is disclosed and claimed anastomosis systems and methods of use 
which overcome many of the disadvantages of the prior art. 
Notwithstanding the inventions of the '584 and '682 applications, a need is 
still deemed to exist for effecting the bypass of two or more vessels, 
ducts, lumens or hollow organs by means of a common anastomosis connector. 
OBJECTS OF THE INVENTION 
It is a general object of this invention to provide connection, e.g., 
anastomosis, systems for coronary bypass grafts and methods of use which 
furthers the state of the art. 
It is a further object of this invention to provide a system and method of 
use for quickly, easily and safely effecting the anastomosis of a 
bifurcated bypass graft to a native blood vessel e.g., the aorta, and two 
downstream native blood vessels, e.g., two coronary arteries. 
SUMMARY OF THE INVENTION 
These and other objects of the instant invention are achieved by providing 
a system for effecting the bypass of portions of at least two downstream 
native blood vessels, e.g., the left anterior descending coronary artery 
and the circumflex coronary artery, from an upstream native blood vessel, 
e.g., the aorta, within the body of a living being by use of at least two 
bypass grafts. The downstream native blood vessels and the upstream native 
blood vessel each have a wall with an opening provided therein. 
The system basically comprises a first upstream anastomosis connector for 
connection to the native upstream blood vessel and at least two downstream 
anastomosis connectors. The downstream anastomosis connectors are arranged 
for connecting the at least two bypass grafts to respective ones of the at 
least two downstream native blood vessels and to the upstream native blood 
vessel, e.g., the downstream ends of the bypass grafts are connected by 
associated snap-connector members to the downstream connectors. The 
upstream connector includes an internal portion arranged to be extended 
through the opening in the upstream blood vessel for communication with 
the interior of the upstream blood vessel and an external portion arranged 
to extend outside the upstream blood vessel. Similarly, each of the 
downstream anastomosis connectors includes an internal portion arranged to 
be extended through the opening in a respective downstream native blood 
vessel for communication with the interior of the respective downstream 
native blood vessel and a external portion arranged to extend outside the 
respective downstream native blood vessel, e.g., for snap-connection to 
the snap connector members at the downstream ends of the bypass grafts. 
The anastomosis connectors of the system are arranged to be coupled 
together to establish a path for carrying blood through the anastomosis 
connectors from the upstream native blood vessel through the at least two 
bypass grafts to the respective downstream native blood vessels. 
In a preferred embodiment of the invention the system also includes a 
midstream anastomosis connector having an inlet port and at least two 
outlet ports. The inlet port of the midstream anastomosis connector is 
arranged to be coupled, e.g., connected via another bypass graft and 
associated snap-connector members, to the external portion of the upstream 
anastomosis connector, while the outlet ports of the midstream anastomosis 
connector are arranged to be coupled, e.g., connected via associated snap 
connector members, to the upstream ends of respective ones of the bypass 
grafts.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS 
Referring now to the various figures of the drawing wherein like reference 
characters refer to like parts, there is shown at 20 in FIG. 1 a connector 
system constructed in accordance with the subject invention. The system 
can be used to effect the anastomosis of any two vessels, ducts, lumens or 
tubular organs. In fact, the system 20 can be used to form a fluid access 
port in any vessel, duct, lumen or tubular organ. 
One particularly useful anastomosis application of the subject system is 
for effecting the bypass of an occluded coronary artery. This may be 
accomplished by forming an anastomotic connection between a saphenous vein 
graft and the aorta upstream of the occluded coronary artery. The 
completed anastomotic connection between the bypass graft and the aorta is 
shown in FIG. 14, wherein the bypass graft is designated by the reference 
numeral 10 and the aorta by the reference numeral 12. 
The system basically comprises a first connector assembly 22 (FIGS. 1 and 
14), a deployment instrument 24 (FIGS. 1 and 12), a piercer-dilator 
instrument 26 (FIG. 2) and an introducer sheath 28 (FIGS. 2 and 7). The 
deployment instrument 24 will be described in considerable detail later. 
Suffice it for now to state that the instrument 24 is arranged to house a 
portion of the connector assembly 22 therein and to deploy it within an 
opening formed in the wall of the vessel, duct, lumen or tubular organ so 
that a fluid access port or an anastomosis connection can be completed. As 
will also be described later, the deployment instrument 24 is arranged to 
be used after the piercer-dilator instrument (or some other means not 
shown) has formed a small opening 14 (FIG. 2) in the wall of the vessel, 
duct, lumen or tubular organ 12 to which the fluid access port or 
anastomosis connection is to be made and the introducer sheath 28 has been 
located within that opening. 
Before describing the details of the piercer-dilator instrument 26, a brief 
description of the introducer sheath 28 is in order. To that end, as can 
be seen best in FIG. 7, the introducer sheath is of generally conventional 
construction and includes an elongated tubular body 30, e.g., an 8-14 
French tube. The tubular body is formed of a biocompatible material, such 
as plastic, and has an open distal end 32 and closed proximal end 34. The 
proximal end 34 is closed by means of a conventional hemostasis valve 
housing including a resilient valve member 36 disposed therein. A sealing 
cap 38 holds the valve member 36 in place and includes a central opening 
40 through which any suitable elongated member or instrument can be passed 
through the valve member 36 and the associated tube 30. As will be 
described hereinafter the piercer-dilator 26 is extended through the 
introducer sheath 28 and those two devices are used together to form the 
small opening 14 in the vessel, duct, lumen or tubular organ. Once the 
opening 14 has been formed, the piercer-dilator is removed from the sheath 
28 and the introducer instrument 24 with the connection assembly 22 
therein is passed through the introducer sheath to deploy the connector 
assembly. In order to prevent excessive penetration of the piercer-dilator 
into the vessel, duct, lumen or tubular organ during the formation of the 
opening 14 in the wall thereof, the introducer sheath 28 includes an 
annular stop 42 closely adjacent its open distal end 32. 
Turning now to FIG. 2, the details of piercer-dilator 26 will now be 
described. Thus, as can be seen therein, the piercer-dilator 26 basically 
comprises an elongated tubular body having a tapered distal end 44. A 
central passageway 46 extends down the entire length of the body 44. A 
needle-plunger 48 extends through the passageway and terminates at its 
distal end in a sharply pointed tip 50. The proximal end of the 
needle-plunger is in the form of an enlarged head or cap 52. A cup shaped 
member 54 is mounted on the proximal end of the tubular body 44 of the 
piercer-dilator 26. The cup shaped member 54 includes central bore recess 
56 arranged to receive one end of a helical compression spring 58. The 
other end of the helical spring engages the under surface of the cap 52. 
The spring is normally in its uncompressed state. It is shown in FIG. 2 in 
its compressed state, i.e., the state wherein the plunger cap 52 is 
pressed in the distal direction with respect to the cup shaped member 54. 
This action causes the piercing point 50 of the plunger to extend out of 
the opening at the tapered distal end of the dilator body 44. It is in 
this condition that the piercer-dilator is used to form the small opening 
14 in the wall of the vessel, duct, lumen or tubular organ to which the 
access port or anastomosis connection is to be made. To that end, the 
piercer-dilator 26 is introduced through the hemostasis valve in the 
introducer sheath 28 until its distal end extends slightly beyond the open 
free end 32 of the sheath 28. A stop (not shown) is provided to ensure 
that the tip of the needle-dilator body does not extend too far beyond the 
open end of the sheath. With the needle-dilator in place the plunger cap 
52 is pressed, i.e., moved distally with respect to the body of the 
piercer-dilator, whereupon the piercing point 50 extends out of the 
piercer-dilator. The exposed pointed tip 50 of the piercer-dilator 
instrument is then brought into engagement with the outer surface of the 
vessel, duct, lumen or tubular body, e.g., the aorta 12, at which the 
opening 14 is to be formed. The introducer sheath and the piercer-dilator 
are then pushed distally in through the wall of the vessel, duct, lumen or 
tubular organ, whereupon a small opening is formed. Further pushing of the 
needle-dilator into the opening enlarges it as the flared conical surface 
of the distal free end of the dilator body 44. Further pushing in the 
distal direction on the piercer-dilator instrument 26 and the introducer 
sheath 28 as a unit causes the distal end of the introducer sheath to 
enter into the opening 14. The combined piercer-dilator instrument and the 
introducer sheath are pushed inward until the stop 42 engages the outer 
surface of the wall of the vessel, duct, lumen or tubular organ. At this 
point, no further penetration can be made. Thus, the stop prevents the 
piercing tip from engaging the wall of the vessel, duct or lumen opposite 
the opening 14. Once the opening has been formed, the piercer-dilator 26 
can then be removed by retracting or pulling on it proximally to withdraw 
it out of the introducer sheath 28 while leaving the introducer sheath in 
place, such as shown in FIG. 7. The system 20 is now ready for the use of 
the deployment instrument 24 to deploy the connector assembly 22 through 
the opening 14 into the interior of the vessel, duct, lumen or tubular 
organ. 
Before describing the details of the deployment instrument 24, a 
description of the connector assembly 22 is in order given. To that end, 
as can be seen clearly in FIGS. 1, 3, 9 and 11, the connector assembly 22 
basically comprises a first connector member 60, an anchor member 62 and a 
second connector member. The first connector member and the anchor member 
are arranged to be deployed within the interior of the vessel, duct or 
lumen and then to be moved with respect to each other to assemble them in 
a manner whereupon the anchor member engages the interior of the vessel, 
duct, lumen or tubular organ contiguous with the opening 14 and a portion 
of the first connector member extends out through the opening 14 to 
provide a fluid access port or a connection point for the second connector 
member 64. In some applications, the first connector member and the anchor 
member can be used in and of themselves to form a fluid access port to the 
interior of the vessel, duct, lumen or tubular organ. 
As can be seen clearly in FIG. 3, the first connector member 60 and the 
anchor member 62 are coupled together by a positioning member, e.g., a 
flexible filament 66. The filament is preferably in the form of a 
conventional resorbable monofilament suture (or if desired a 
non-resorbable suture). 
The anchor member 62 is an elongated strip formed of a resorbable, somewhat 
rigid material, such as polyglactide, polyglycolide or copolymers thereof. 
Non-absorbable materials, e.g., stainless steel, can be used for the 
anchor member. Each end of the anchor member 62 is rounded at 70. The 
first connector member 60 basically comprises a tubular body, preferably 
formed of the same material as that forming the anchor 62, and having a 
central passageway 72 extending therethrough. One end of the tube 74 is in 
the form of an annular flange. The flange need not be annular, and thus 
may merely be a tab or projection. The other end of the tube is in the 
form of at least one undercut annular lip or detent 76 whose exterior 
surface is chamfered. The outer surface 78 of the tubular connector body 
60 between the flange 74 and the detent 76 is somewhat conical, i.e., is 
in the form of a surface which tapers from the flange 74 to the detent 76. 
The maximum outer diameter of the detent 76 of the connector member 60 is 
just slightly larger than the inside diameter of the hole 68 in the anchor 
member 62. A small aperture 80 extends radially outward from the central 
passageway 72 of the first connector member 60 through the annular flange 
74. 
As best seen in FIGS. 1 and 3, the filament 66 includes a pair of 
sequentially located sections 66A and 66B. In particular, section 66A 
extends from the proximal end of the deployment instrument 24 down the 
interior of that instrument through the central opening 68 in the anchor 
member 60, through the central passage 72 in the first connector member 60 
from whence it doubles back to merge with the filament section 66B. The 
section 66B extends through the aperture 80 back into the interior 
passageway 72 in the first connector member 60 and through the central 
opening 68 in the anchor member 62. From there the section 66B of the 
filament 66 extends in the proximal direction through the deployment 
instrument to the proximal end thereof. 
As mentioned earlier, the details of the deployment instrument will be 
described later, suffice it for now to state that this instrument includes 
a carrier 82 in the form of a tubular body in which the anchor member 62 
and the first connector member 60 of the connector assembly 22 are 
disposed. The carrier tube includes an open, free (distal) end 84. As can 
be seen in FIGS. 1 and 3, the first connector member 60 is disposed within 
the carrier tube 82 immediately adjacent the open distal end 84, while the 
anchor member 62 is disposed immediately proximally of the first connector 
member. 
The deployment instrument 24 also includes a guide-pusher assembly located 
within the carrier tube. The guide pusher assembly includes a tubular 
guide-pusher member 86 having a conical distal portion end 88. The free 
end 90 of the guide-pusher member includes a small opening communicating 
with the hollow interior of the guide-pusher and through which the 
filament sections 66A and 66B extend. The end 90 of the pusher member 86 
is located immediately adjacent the proximally located rounded distal end 
70 of the anchor member 62, when the anchor member is within the carrier 
tube in place as shown in FIGS. 1 and 3. 
Deployment of the first connector member 60 and anchor member 62 is 
accomplished by operating the guide-pusher assembly, as will be described 
later, to cause the guide-pusher member 86 to push on the proximal end 
portion 70 of the anchor member 62 which in turn pushes on the distally 
located connector member 60 to expel the first connector member 60 out of 
the open free end 84 of the carrier member and out of the open end 32 of 
the introducer sheath 28 into the interior of the vessel, duct, lumen or 
tubular organ. Continued pushing on the guide pusher 86 in the distal 
direction then ejects the anchor member 62 into the interior of the 
vessel, duct, lumen or tubular organ. 
In order to assemble the first connector member and anchor member and cause 
the detent end of the first connector member to be extended through the 
opening 14 in the wall of the vessel, duct, lumen or tubular organ, the 
two extending sections 66A and 66B of the filament 66 are retracted in the 
proximal direction, by means forming a portion of the instrument 24 to be 
described later. In particular, this retraction action on the filament 
sections pulls the first connector member toward the anchor member, 
whereupon the chamfered surface 76 of the first connector member enters 
into the central opening 68 in the anchor member. Continued retraction on 
the filament causes the anchor member to engage the interior surface of 
the vessel, duct, lumen or tubular organ contiguous with the opening 14 
with the central opening 68 in the anchor member overlying the opening 14. 
Continued retraction of the two filament sections pulls the first 
connector member further into the central opening 68 in the anchor member, 
whereupon the portions of the anchor member contiguous with the central 
opening ride up the surface 78 of the first connector member until the 
flange 74 of the first connector member abuts the distally directed top 
surface of the anchor member 62, as shown in FIGS. 9 and 10. The 
retraction of the first connector member through the central opening 68 in 
the anchor member 62 causes the chamfered proximal end of the first 
connector member to pass through the opening 14 in the wall of the vessel, 
duct, lumen or tubular organ 12, as shown in FIG. 10. During the 
retraction of the filament sections 66A and 66B, the guide-pusher member 
86 remains stationary so that its tapered distal end 88 enters into the 
central passageway 72 of the first connector member 60 when the first 
connector member is pulled through the opening 14 in the wall of the 
vessel, duct, lumen or tubular organ. Thus, the tapered end of the 
guide-pusher member 86 serves to guide or orient the first connector 
member 60 so that its central longitudinal axis is disposed generally 
perpendicularly to the wall of the vessel, duct, lumen or tubular organ 
12, as shown in FIG. 10. 
With the first connector member 60 and the anchor member 62 deployed as 
shown in FIG. 10, the system is now ready to complete the anastomosis. To 
that end, the second connector member 64 is pre-mounted on the distal end 
of any desired vessel, duct, lumen or tubular organ like that shown in 
FIG. 11. For example, as shown in FIG. 11, the connector 64 can be 
disposed and secured within the open distal end of a saphenous vein bypass 
graft 10. The second connector member basically comprises a hollow tubular 
member, formed of the same material as that of the first connector 60 and 
the anchor member 62. The distal end of the second connector 64 is in the 
form of an annular flange 92. The outer surface of the tubular connector 
64 proximally of the flange 92 is in the form of a slightly outwardly 
tapering conical surface 94, i.e., a surface whose diameter increases 
linearly in the proximal direction. A central passageway 96 extends 
through the length of the connector member 64, the proximal end of the 
passageway 96 forms a flared throat 98. Three annular undercut detent 
rings 100, 102 and 104 extend about the inter-periphery of the central 
passageway 96 at closely spaced locations adjacent the flanged distal end 
92 of the connector 64. The outer surface of each of these detents is 
chamfered and is arranged to cooperate and engage the chamfered surface of 
the detent 76 of the first connector member 60 to lock the two connector 
members together, as will be described later. The flared proximal end of 
the second connector 64 is located within the hollow interior lumen of the 
bypass graft 10 and is secured in place therein by plural stainless steel 
springs 106. The springs extend about the periphery of the distal end of 
the bypass graft to interpose that portion of the bypass graft tightly 
between the springs and the exterior surface 94 of the second connector 
member 64. Thus, the second connector member is fixedly secured to the 
distal end of the bypass graft. 
The bypass graft with the second connector member fixedly secured thereto 
as shown in FIG. 11 is arranged to be deployed or slid down over the 
deployment instrument 24, as will be described later, and over the 
guide-pusher member 86 like shown in FIG. 13, whereupon the flange 92 of 
the second connector member 64 abuts the exterior surface of the vessel, 
duct, lumen or tubular organ contiguous with the opening 14 therein. The 
undercut surface of the detent surface 76 of the first connector member 
engages one of the undercut surfaces of the three chamfered detent rings 
100, 102 or 104, with the particular detent being engaged being dependent 
upon the thickness of the wall of the vessel, duct, lumen or tubular 
organ. 
In the embodiment shown in FIG. 13, the undercut portion of the detent 76 
of the first connector member 60 engages the undercut portion of the 
detent ring 102 of the second connector member 64. This action effectively 
sandwiches the wall of the vessel, duct, lumen or tubular organ between 
the flange 92 of the second connector member 64 and the anchor member 62, 
thereby fixedly securing the connector assembly 22 in place within the 
opening 14, thereby completing the anastomosis. 
In accordance with a preferred embodiment of this invention, a washer 108 
is interposed between the flange 92 of the second connector member 64 and 
the outer surface of the wall of the vessel, duct, lumen or tubular organ 
contiguous with the opening 14 to prevent bleeding at the interface of the 
connector assembly and the opening 14 in the wall of the vessel, duct, 
lumen or tubular organ. The washer is preferably formed of a hemostatic 
material, e.g., collagen. 
As should be appreciated from the previous discussion, the embodiment of 
the connector assembly 22 described heretofore makes use of components 
which are coupled together, but not assembled. By that it is meant that 
the components are disposed with respect to each other so that they are 
held in a compact configuration within the carrier tube for expulsion into 
the interior of the vessel, duct, lumen or tubular organ. Once expelled 
they are movable or positionable with respect to each other and with 
respect to the wall of the vessel, duct, lumen or tubular organ to 
assemble them in their "deployed state." In the deployed state the 
portions are oriented with respect to each other so that they are 
resistant to accidental dislodgement within the opening in the wall of the 
vessel, duct, lumen or tubular organ. In particular, the anchor member, 
lying against the interior wall of the vessel, duct, lumen or tubular 
organ contiguous with the opening prevents the deployed connector assembly 
from falling out of that opening. 
In FIG. 4 there is shown an alternative embodiment of a connector assembly 
222 constructed in accordance with this invention. The assembly 222 is 
similar in many respects to the connector assembly 22, but in other ways 
differs. In this connection, the connector assembly 222 includes 
components which are preassembled so that they are connected to each other 
prior to deployment. These preassembled components are held in a compact 
or "stowed" state within the carrier tube 82 so that they can be ejected 
from the carrier tube as a unit into the interior of the vessel, duct, 
lumen or tubular organ. Once ejected, the connector assembly 222 can then 
be retracted in a similar manner to that described heretofore to bring a 
portion of it into engagement with the wall of the vessel, duct, lumen or 
tubular organ contiguous with the opening 14 while another portion extends 
out to that opening for connection to the second connector member 64. The 
connector assembly 222 basically comprises a first connector member 224, 
an anchor member 62 and a second connector member 64. The anchor member 62 
and the second connector member are identical to those components making 
up the connector assembly 22. Thus, in the interest of brevity, the 
details of the anchor component 62 and the second connector component 64 
will not be reiterated and the various portions of these components will 
be given the same reference numerals as given previously. 
The first connector member 224 is preferably formed of the same material as 
that of the anchor member 62. Moreover, the first connector member 224 
includes various portions which are constructed similar to the connector 
member 60 of connector assembly 22. Thus, in the interest of brevity, the 
portions of the first connector assembly 224 which are similar to those 
portions of the first connector 60 will be given the same reference 
numerals. In particular, the first connector member 224 is a tubular 
member having a central passageway 72 extending through it. The distal end 
of the connector member 224 is in the form of an annular flange 84 while 
the proximal end is in the form of a chamfered surface detent 76. The 
outer surface of the connector between the flange 84 and the detent 76 is 
of circular profile and extends through the central opening 68 in the 
anchor member 62 so that the connector member 224 is slidable 
longitudinally within that opening. The connector assembly 222 is arranged 
to be disposed in a compact or "stowed" position within the carrier tube 
82 of the deployment instrument. In particular, the connector 224 is 
centered within the opening 68 in the anchor 62, as shown in FIG. 4 to 
ensure that it has the smallest cross sectional profile for disposition 
within the carrier tube. 
A pair of apertures 226 extend radially inward through the flange 84 to 
enable the filament 66 to be coupled to the connector member 224. In 
particular, the filament section 66B extends through the open proximal end 
of the central passage 72 of the connector member 224 and out through one 
of the apertures 226. The filament section 66B extends into the other 
aperture 226. From that point, the filament section 66B extends through 
the passageway 72 and out the proximal end thereof. The proximal end 
portions of filament sections 66A and 66B extend through the guide-pusher 
and through the deployment instrument, as will be described later. 
Deployment of the connector assembly 222 is accomplished in a similar 
manner to that of connector assembly 22. In this regard, the guide-pusher 
assembly is used to push the assembled connector 224 and anchor 62 out of 
the carrier tube so that the preassembled connector member 24 and the 
anchor member 62 are located within the interior of the vessel, duct, 
lumen or tubular organ. Retraction of the filament sections 66A and 66B 
brings the proximal end of the connector member 224 back through the 
opening 14 in the wall of the vessel, duct, lumen or tubular organ. 
Moreover, retraction of the filament sections causes the top or proximal 
surface of the anchor member 62 to move into engagement with the inner 
surface of the vessel, duct, lumen or tubular organ contiguous with the 
opening 14, thereby causing the anchor member to "hang-up" on that 
surface. Further, retraction of the filament sections moves the connector 
member 224 with respect to the anchor member, i.e., it causes the 
connector member to slide through the hole 68 in the anchor member, so 
that more of the connector member 224 extends out of the opening in the 
wall of the vessel, duct, lumen or tubular organ until its flange 84 
engages the bottom or distal surface of the anchor member contiguous with 
the hole 68. At this time, the connector device 224 is fully deployed and 
ready for connection to the connector member 64 and the bypass graft 10 
connected to that connector. That connection is accomplished in the same 
manner as with the connector assembly 22 described earlier. 
In FIG. 5, there is shown another alternative embodiment 32 of a connector 
assembly constructed in accordance with this invention. The connector 
assembly 322 is somewhat similar to the connector assembly 222 in that it 
is preassembled, i.e., its first connector and anchor components are 
assembled or connected to each other, but are movable relative to each 
other during the deployment procedure. In the interest of brevity, the 
common components of the connector assembly 322 and connector assembly 222 
and connector assembly 22 will be given the same reference numerals and 
the details of their construction and operation will not be reiterated. 
Thus, as can be seen in FIG. 5, the connector assembly 322 basically 
comprises a first connector member 324 and an anchor member 326. The first 
connector member 324 and the anchor member 326 are an integral unit, with 
the anchor unit 326 being similar in construction to the anchor member 62. 
Thus, the anchor member includes a central hole 68. The first connector 
member 324 is a collapsible, e.g., a corrugated, tube having a central 
passageway 72 extending therethrough. The distal end of the corrugated 
tube 324 is in the form of a flange 328 which is received within a 
correspondingly shaped annular recess 330 extending about the hole 68 in 
the anchor member 326. The tube 324 is arranged to be held in its compact 
or "stowed" state as shown in FIG. 5 when it is within the carrier tube of 
the deployment instrument, and to be extended to its deployed state, as 
shown in FIG. 6, during its deployment. 
The proximal end of the collapsible corrugated tube 324 is in the form of 
an annular collar 332 forming a detent having a chamfered surface 76. The 
collar 332 is fixedly secured to the proximal end of the corrugated tube 
324. 
The anchor member 326 is preferably formed of a resorbable material, like 
that of the anchor members described heretofore. The corrugated tube may 
also be formed of the same resorbable material. Alternatively, it may be 
formed of any conventional biocompatible material, such as Dacron mesh, 
providing that it is impervious to the flow of liquid through it so that 
fluid flowing through the central passageway 72 will not leak out the wall 
of the corrugated tube 324 much like a synthetic vascular graft. 
A radially oriented aperture 334 is provided in the annular collar 332 
through which the filament 66 extends so that one filament section 66B 
extends from one side of the aperture while the other filament section 66A 
extends from the other. 
The connector assembly 322 is disposed within the carrier tube 82 in its 
compact state like that shown in FIG. 5, so that its anchor member is 
oriented parallel to the central longitudinal axis of the carrier tube and 
immediately distally of the distal end 90 of the guide-pusher member 86. 
The filament sections 66A and 66B extend back through the interior of the 
guide-pusher and through the deployment instrument. The connector assembly 
322 is ejected from the carrier tube in the same manner as described with 
reference to the connector assemblies 22 and 222. Once ejected into the 
interior of the vessel, duct, lumen or tubular organ, the two filament 
sections 66A and 66B are retracted. As will be described later, to draw 
the collar 332 of the connector assembly 332 back through the opening 14 
in the wall of the vessel, duct, lumen or tubular organ. Continued 
retraction of the filament sections cause the top or proximal surface of 
the anchor member 326 to engage the interior surface of the vessel, duct, 
lumen or tubular organ contiguous with the opening 14 to cause it to 
hang-up in the same manner as described earlier. Once the anchor hangs-up, 
continued retraction of the filament section cause the corrugated tube 324 
to stretch or straighten out, thereby increasing the length of the tube 
from the state shown in FIG. 5 to the state shown in FIG. 6. Once the 
connector assembly 322 is in the fully deployed state shown in FIG. 6, the 
second connector member 64 and the bypass graft 10 connected to it can be 
secured to the assembly 322 in the same manner as described heretofore. 
Referring now to FIGS. 1 and 12, the details of the deployment instrument 
24 will now be described. Thus, as can be seen the deployment instrument 
24 basically comprises the heretofore identified carrier tube 82 and the 
heretofore described pusher-guide assembly. That assembly includes the 
pusher-guide member 86 and an actuation assembly 110. 
The carrier tube 84 includes an annular ring or stop 112 secured about is 
outer periphery immediately adjacent the proximal end 114. The stop 112 is 
provided to ensure that the carrier tube of the deployment instrument is 
not extended too far into the introducer sheath 28. Thus, the stop is 
arranged to engage the rear wall 38 of the hemostasis valve when it is in 
proper position. 
The proximal end 114 of the guide tube is in the form of an inwardly 
extending, annular wall 116 having a central passageway 118 therein. The 
passageway 118 is adapted to closely receive the outer surface of the 
cylindrical portion of the pusher-guide member 86 to form a generally 
fluid-tight seal therebetween. The proximal end 120 of the pusher-guide 
member 86 is in the form of an inwardly extending annular wall 122 having 
a central passageway 124 therein. The central passageway 124 is arranged 
to closely receive a portion of the actuation assembly 110 (to be 
described hereinafter) to form a generally fluid tight seal therebetween. 
The actuation assembly 110 basically comprises an elongated cylindrical 
mandrel rod 126 having a central passageway 128 extending along its length 
between its open distal end 130 and its open proximal end 132. The 
passageway 128 communicates with the interior of the pusher-guide member 
86. An actuation cap 134 is mounted on the proximal end of the mandrel 
rod, with a helical compression spring 136 extends about the outer 
periphery of the hollow mandrel rod 126 interposed between the proximal 
end 120 of the pusher-guide tube 86 and a stop surface 138 forming the 
distal end of the actuation cap 134. The cap 134 basically comprises a 
pair of hollow tubular sections 140 and 142. The section 142 is disposed 
proximally of section 140 and is cup-shaped. The section 140 is fixedly 
secured to the mandrel rod 126 with the distal end of the filament section 
66B tightly interposed therebetween. In particular, filament sections 66A 
and 66B extend from the connector assembly 22 through the pusher-guide 
member 86 into the hollow interior of the mandrel rod 126 and out the 
proximal end opening 132 of the passageway 128 extending through the 
mandrel rod 126. The distal end portion of filament 66B extends under the 
cup-shaped cap section 142 and is trapped between the outer surface of the 
mandrel rod 126 and the inner surface of the cap shaped 140. The distal 
end of the filament section 66A also extends out the proximal end 132 of 
the passageway 128 and is trapped between the outer surface of the mandrel 
tube 128 and the inner surface of the cup-shaped portion 142 of the cap 
134. The cup-shaped portion 142 of the cap is removable for reasons to be 
described later. 
The cap 134 also includes a central aperture in its end wall in 
communication with the interior passageway 128 of the mandrel tube 126. A 
plug, formed of a resilient material, such as rubber, is releasably 
located within the aperture 144 to seal it. The aperture 144, with the 
plug removed serves as a means to enable the deployment instrument 24 to 
determine the location of the wall of the vessel, duct, lumen or tubular 
organ as will be described later. 
Operation of the deployment instrument 24 is as follows: 
The instrument is inserted into the introducer sheath after the sheath has 
been positioned with the piercer-dilator to form the opening 14 in the 
wall of the vessel, duct, lumen or tubular organ and the piercer-dilator 
has been removed. To that end, the deployment instrument is extended 
through the introducer sheath which is positioned as shown in FIG. 7 until 
the stop ring 112 on the deployment instrument 24 abuts the proximal end 
38 of the hemostasis valve of the introducer sheath 28, as shown in FIG. 
8. The cap 134 of the actuation assembly 110 is then pushed in the distal 
direction, thereby imparting movement in the distal direction to the 
pusher-guide tube 86 via the interposed spring 136. This action causes the 
free distal end 90 of the guide-pusher member to engage the proximal end 
of the anchor member 64 of the connector assembly 22 within the carrier 
tube 82. Continued pushing on the cap in the distal direction causes the 
pusher-guide member to eject the first connector member 60 and the anchor 
member 62 as described heretofore. Once the connector assembly's 
components are free of the guide tube and are located within the interior 
of the vessel, duct, lumen or tubular organ, the spring in attempting to 
assume its uncompressed natural state, applies tension to the filament 
sections 66A and 66B. In particular, the release of pressure on the cap 
136 allows the spring to move from its compressed state shown in FIG. 1 to 
a longitudinally expanded or uncompressed state shown in FIG. 12. Since 
the filament ends are trapped by the cap 134, this action pulls the 
filament sections in the proximal direction, thereby drawing the 
components 60 and 62 of the first connector assembly 22 into the deployed 
state shown in FIGS. 9 and 10. Once the components are in this state, the 
introducer sheath is withdrawn, i.e., pulled off the instrument, leaving 
the deployment instrument 24 in the position shown in FIG. 12. 
The second connector member 64 with the bypass graft 10 secured thereto is 
then threaded and slid down the instrument 24 over the actuation assembly 
and the pusher-guide tube to the position shown in FIG. 12. If a 
hemostatic washer 108 is used, as is preferable, that washer is threaded 
on the deployment instrument in advance of the second connector member 64. 
When the second connector member 64 and the associated bypass graft 10 are 
slid in a distal direction until the flange 92 either directly engages the 
anchor surface of the wall of the vessel, duct, lumen or tubular organ or 
indirectly engages it via an interposed hemostatic washer 108. One of the 
chamfered detents of the second connector member 64 will be engaged by 
chamfered detent 76 of the first connector member 60 to secure the first 
and second connector members together. 
Once the connector members 60 and 62 are connected together, the deployment 
instrument 24 can be removed to leave the anastomotic connection in 
position. To that end, the cup-shaped portion 142 of the actuating cap 134 
is removed, thereby freeing the proximal end of filament section 66A. The 
remaining portion 142 of the cap 146 is then pulled or withdrawn in the 
proximal direction to withdraw the deployment instrument from within the 
interior of the bypass graft 10. Since the proximal end of filament 
section 66A is no longer trapped but the proximal end of the filament 
section 66B is trapped by the cap section 140 retraction of the instrument 
24 causes the filament section 66A to move down the passageway 128 of the 
mandrel tube. Eventually, the free end of section 66A will pass through 
the aperture 80 in the first connector member 60 and from there will be 
pulled through the passageway 72 of that member and through the bypass 
graft interior until it exits the proximal end of the graft. At this 
point, the deployment instrument 24 will be fully removed from the 
anastomotic connection, leaving that connection in the state shown in FIG. 
14. 
The proximal end (not shown) of the bypass graft 10 can be secured to the 
occluded coronary artery (not shown) distally of the occlusion by any 
suitable technique. For example, the distal end of the bypass graft can be 
surgically connected to the coronary artery, or it can be connected 
utilizing means similar to that described herein introduced via an access 
port or slit (not shown) made in the wall of the bypass graft or by means 
such as taught in our co-pending U.S. patent application identified above. 
As mentioned earlier, the actuation cap 134 of the deployment instrument 24 
includes an aperture 144 which is sealed with a plug 146. The aperture 144 
enables one to determine if the deployment instrument is properly 
positioned with respect to the wall of the vessel, duct, lumen or tubular 
organ. This action is accomplished by removing the plug 146 from the 
aperture so if the instrument is disposed at the desired position it will 
be in communication with the interior of the vessel, duct, lumen or 
tubular organ. Accordingly, blood will be enabled to flow from the 
interior of the vessel, duct, lumen or tubular organ and through the 
hollow interior of the pusher-guide member, and the communicating 
passageway in the mandrel tube where it exits the proximal end of that 
passageway and through communicating port 144. Thus, when a drop of blood 
or other fluid appears at the port, the user of the instrument 24 knows 
that the device is in the desired position. The plug 146 can then be 
reinserted into the aperture 144 to seal it so that no further blood can 
gain egress through the instrument 24. 
It should be pointed out at this juncture that the piercer-dilator 
instrument 26 may be constructed to utilize a similar flashback 
construction to provide an indication of proper placement, by the egress 
of a drop of blood from the proximal end of the piercer-dilator. More 
likely, the formation of the opening in the wall of the vessel, duct, 
lumen or tubular organ will be preformed under direct vision. If a fluid 
flashback system is incorporated into piercer-dilator, or the introducer 
sheath, it will allow placement of the introducer sheath at a specific 
location within the vessel, duct, lumen or tubular organ without the need 
for direct observation. 
It must be pointed out at this juncture that it is contemplated that the 
connector assemblies of this invention could be actively assembled or 
deployed by manual pulling of the filament sections and pushing on the 
pusher member instead of using a spring loaded system like described 
heretofore. 
The bypass graft 10 is prepared by inserting the proximal end of the second 
connector member 64 into the open distal end of the graft section 10. The 
connector is held in place by use of one or more stainless steel spring 
clips 106. The spring clips and the second connector 64 are preferably 
available in different sizes to cater to different graft sizes. In 
particular, the spring clips 106 are sized to a predetermined inside 
diameter to limit the constriction of the graft which would otherwise 
cause necrosis of the interposed tissue due to excessive pressure. Other 
means can be utilized to secure the graft 10 to the second connector 
member 64. Such means may be a biocompatible adhesive, pre-knotted suture 
loops, sutures, c-clips, etc. 
The inside profile of the passageways of the connector assemblies of this 
invention are preferably designed to minimize turbulence and control the 
pressure of fluid flowing therethrough, such as disclosed in our 
heretofore identified co-pending patent application. It should also be 
pointed out that the various connector components of the connector 
assemblies of this invention can be coated with, or impregnated with 
chemicals, drugs, or other biologically active components to affect the 
nearby tissue or cells. Such active components could include, but are not 
limited to, anti-platelet drugs, antimicrobial agents, antibiotics, 
anti-thrombogenic materials, anti-oxidants, growth factors, growth 
hormones, genetic material, or seeded cells. 
It should be noted that the embodiments of the connector assemblies and/or 
the deployment instrument and/or the piercer-dilator instrument, and/or 
the introducer sheath as shown and described heretofore are merely 
exemplary. Thus, other constructions are contemplated. For example, the 
anchor member may be shaped other than a linear strip, e.g., it may be 
slightly arcuate or trough-shaped like that disclosed in our 
aforementioned copending application. The positioning member for the 
connector assemblies may comprise other types of components making use of 
at least one filament or may comprise other devices, such as a flexible 
wire having a balloon on its distal end. The connector assemblies and/or 
the components thereof need not be formed to be totally resorbable. Thus, 
none or only portions of such assemblies may be resorbable. 
In FIG. 15 there is shown by means of an illustration the anterior side of 
a human heart 2 which has had two occluded coronary arteries, namely, the 
left anterior descending 4 and the circumflex 6, bypassed by a bifurcated 
bypass graft composed of three graft sections 10A, 10B and 10C (to be 
described later) using an anastomosis connection system 200 constructed in 
accordance with one aspect of this invention. The system 200 basically 
comprises an upstream anastomosis connector 202, a pair of downstream 
anastomosis connectors 204 and 206 and an intermediate or midstream 
bifurcated anastomosis connector 208, so that both coronary arteries can 
be bypassed from a common, single connection point at the aorta. 
It should be pointed out at this junction that the system 200 may be used 
to bypass more than two coronary arteries via a single common connection 
to the aorta using the teachings of this invention. Thus, for example, the 
intermediate or midstream connector may be trifurcated, i.e., have one 
input passageway or port and three output passageways or ports 
communicating with the input passageway. That trifurcated anastomosis 
connector may be used to connect three bypass grafts sections to the 
common, single connection point at the aorta, and with the downstream ends 
of the three bypass graft sections being connected to respective coronary 
arteries downstream of the occlusions therein. Other anastomosis 
connectors for connecting more than three bypass graft sections to a 
common aortic connection point may be provided in accordance with this 
invention. 
Irrespective of how many bypass graft sections are to be connected to the 
common junction with the aorta, it is preferred that all of the 
anastomosis connectors used to achieve that end be formed of a resorbable 
material, like that described heretofore, although it is contemplated that 
some or all of the connectors of the system may be formed of 
non-resorbable, biocompatible materials depending upon the application 
desired. The upstream and downstream anastomosis connectors are preferably 
constructed in accordance with the teachings of either the '582 or '684 
applications, although they can be of different constructions as well, 
depending upon the desires of the surgeon and the particular anatomical 
structures to be encountered. 
Turning now to the exemplary embodiment of the anastomosis connector system 
shown in FIG. 15, it can be seen that the proximal tubular portion 202A of 
the upstream anastomosis connector 202 extends out of the opening (not 
shown) in the aorta through which it was placed. This outwardly extending 
portion may be linear, curved, angled, elbowed, etc., and may extend 
perpendicularly to the longitudinal axis of the aorta, or at some angle to 
it. In the embodiment shown the outwardly extending portion 202A is in the 
form of a right-angle elbow which includes a linear portion extending 
perpendicularly to the longitudinal axis of the aorta, and a free end 
extending parallel to that longitudinal axis. It is the free end of the 
portion 202A to which the bypass graft section 10A is connected. That 
graft section is similar to the grafts described heretofore. Moreover, the 
proximal end of the graft section 10A is connected to the free end of the 
anastomosis connector portion 202A via a snap-connector (like that 
disclosed earlier, e.g., connector 64) fixedly secured to the proximal end 
of the graft section 10A. A hemostatic, e.g., collagen, ring 210 may be 
provided extending about the periphery of the anastomosis connector 
portion 202A where it extends out of the opening in the aorta to prevent 
the leakage of blood at that interface. Alternatively, an adhesive or some 
other flowable or settable material may be used at this location to seal 
that interface. 
The distal end of the graft section 10A is connected via a similar 
snap-connector to the inlet passageway or port (to be described later) of 
the bifurcated anastomosis connector 208. The two other bypass graft 
sections 10B and 10C are connected to the two outlet passageways or ports 
(also to be described later) of the bifurcated anastomosis connector 208, 
via respective snap-connectors located at their respective proximal ends. 
The distal ends of the bypass graft sections 10B and 10C are connected via 
respective snap connectors to the downstream anastomosis connectors 204 
and 206, respectively. These downstream anastomosis connectors 204 and 206 
are constructed similarly to the upstream connector 202, except that as 
shown the outwardly extending tubular portion 204A of the downstream 
connector 204 is not in the form of an elbow. Rather it is linear in shape 
so that it extends perpendicularly to the longitudinal axis of the left 
anterior descending artery 4 downstream of the occlusion therein. The 
other downstream anastomosis connector 206 does include a tubular elbow 
shaped extending portion 206A, and that portion extends out of the opening 
in the wall of the circumflex artery 6 downstream of the occlusion 
therein. 
It should be noted that the choice of shape of the outwardly extending 
portions of the upstream and/or downstream anastomosis connector will be 
left up to the surgeon based on his/her desires and the anatomical 
structures involved. 
If desired, a hemostatic ring or an adhesive, glue or some other flowable, 
settable material may be used at the interface of either of the downstream 
anastomosis connectors and the opening in the wall of the artery through 
which they extend to effect the sealing of that interface. 
As can be seen in FIG. 15, the bifurcated midstream anastomosis connector 
208 comprises a generally Y-shaped hollow member having an input port 208A 
through which a central passageway (not shown) extends, and a pair of 
output ports 208B and 208C. Each of these ports includes a central 
passageway (not shown) extending therethrough. The three passageways are 
in fluid communication with one another at a smooth walled internal 
junction to minimize blood turbulence therein. Moreover, the cross 
sectional area of each of the passageways may be sized and shaped to 
further minimize blood turbulence. Thus, blood entering into the input 
port's passageway from the aortic connection will branch off and flow into 
each of the output passageways of the bifurcated anastomosis connector for 
passage via their respective ports and associated bypass graft sections to 
the respective coronary arteries to which the bypass graft sections are 
connected 
The deployment of the upstream anastomosis connectors may be accomplished 
in any manner desired in accordance with the teaching of this application 
or the '582 or '684 applications. Thus, for example, if the upstream 
(aortic) anastomosis connector 202 is constructed like the heretofore 
described anastomosis connector 22 it may be deployed by use of the 
instrument 24 in a similar manner to that described above. The bypass 
graft section 10A with a snap-connector 62 on its proximal end can then be 
snap-connected to the outwardly extending tubular portion 202A of the 
upstream anastomosis connector 202 using that instrument and in the same 
manner as described above. Each of the downstream anastomosis connectors 
204 and 206 can be similarly constructed to the upstream connector 202 and 
deployed in their respective coronary arteries 4 and 6 downstream of the 
occlusions in a similar manner. Once deployed the bypass graft section 10B 
with a snap-connector 62 on its proximal end can then be snap-connected to 
the outwardly extending tubular portion 204A of the downstream anastomosis 
connector 204 in the same manner as described above. Similarly, the bypass 
graft section 10C with the snap-connector 62 on its proximal end can be 
snap-connected to the outwardly extending tubular portion 206A of the 
downstream anastomosis connector 206. 
Once all of the bypass graft sections 10A-10C have be connected to their 
respective native arteries they can be connected to one another via the 
midstream bifurcated anastomosis connector 208. To that end the distal end 
of the bypass graft section 10A having a snap-connector 62 fixedly secured 
thereto can be snap-connected to a mating portion (not shown) constructed 
like detent 76 on the upstream port of the bifurcated anastomosis 
connector 208. The proximal end of the bypass graft section 10B having a 
snap-connector 62 fixedly secured thereto can be snap-connected to a 
mating portion (not shown) constructed like detent 76 on one of the 
downstream ports of the bifurcated anastomosis connector 208. In a similar 
manner the proximal end of the bypass graft section 10C having a 
snap-connector 62 fixedly secured thereto can be snap-connected to a 
mating portion (not shown) constructed like detent 76 on the other of the 
downstream ports of the bifurcated anastomosis connector 208. This 
completes the assembly of the bypass graft system to enable blood to flow 
from the aorta around the occluded coronary arteries to points downstream 
of the occlusions therein. 
Without further elaboration the foregoing will so fully illustrate our 
invention that others may, by applying current or future knowledge, adopt 
the same for use under various conditions of service.