U.S. patent application number 10/071056 was filed with the patent office on 2002-07-25 for device for sealing a vessel during coronary artery bypass surgery.
Invention is credited to Aldrich, William N., Baughman, Thomas L., Benetti, Federico J., Bennett, Brian J., Billig, Michael J., Fogarty, Thomas J., Frantzen, John J., Ginn, Richard S., Glines, Robert C., Green, Harry L., Morejohn, Dwight P., Regan, Brent, Reis, Eugene E., Salahieh, Amr, Sepetka, Ivan, Sherman, Benjamin, Skieller, Christian, Subramanian, Valavanur A., Taylor, Charles S., Weller, Gary B., Witt, William F..
Application Number | 20020099270 10/071056 |
Document ID | / |
Family ID | 27084504 |
Filed Date | 2002-07-25 |
United States Patent
Application |
20020099270 |
Kind Code |
A1 |
Taylor, Charles S. ; et
al. |
July 25, 2002 |
Device for sealing a vessel during coronary artery bypass
surgery
Abstract
The invention is methods and devices which a surgeon may use to
stabilize the beating heart during a surgical procedure on the
heart. Pursuant to the invention, a stabilizing device is
introduced through an opening in the chest and brought into contact
with the beating heart. By contacting the heart with the device and
by exerting a stabilizing force on the device, the motion of the
heart caused by the contraction of the heart muscles is effectively
eliminated such that the heart is stabilized and the site of the
surgery moves only minimally if at all. Typically, in separate
steps, the surgeon contacts the heart with the stabilizing means,
assesses the degree of movement of the anastomosis site, and exerts
a force on the stabilizing means such that the contraction of the
beating heart causes orgy minimal excess motion at the surgery
site. By fixing the position of the stabilizing means in a
configuration where the motion of the beating heart is effectively
eliminated, the surgeon is able to stabilize the beating heart for
the duration of the procedure. The stabilizing means may be
attached to a rigid support or may be attached to a semi-rigid
support which is rendered motionless mechanically, chemically, or
by human intervention. In certain preferred embodiments, the
stabilizing means is affixed to a semi-rigid support which is
caused to become rigid, by any of a variety of techniques, such
that the position of the stabilizing means becomes fixed by the
support, and the heart remains substantially motionless for the
duration of the procedure.
Inventors: |
Taylor, Charles S.; (San
Francisco, CA) ; Aldrich, William N.; (Redwood City,
CA) ; Baughman, Thomas L.; (Cupertino, CA) ;
Benetti, Federico J.; (200 Rosario, AR) ; Bennett,
Brian J.; (Menlo Park, CA) ; Billig, Michael J.;
(Cupertino, CA) ; Fogarty, Thomas J.; (Portola
Valley, CA) ; Frantzen, John J.; (Copperopolis,
CA) ; Ginn, Richard S.; (San Jose, CA) ;
Glines, Robert C.; (Cameron Park, CA) ; Green, Harry
L.; (Santa Cruz, CA) ; Morejohn, Dwight P.;
(Davis, CA) ; Regan, Brent; (Davis, CA) ;
Reis, Eugene E.; (San Jose, CA) ; Salahieh, Amr;
(Campbell, CA) ; Sepetka, Ivan; (Los Altos,
CA) ; Sherman, Benjamin; (Milpitas, CA) ;
Skieller, Christian; (Redwood City, CA) ;
Subramanian, Valavanur A.; (New York, NY) ; Weller,
Gary B.; (Los Gatos, CA) ; Witt, William F.;
(Palo Alto, CA) |
Correspondence
Address: |
BOZICEVIC, FIELD & FRANCIS LLP
200 MIDDLEFIELD RD
SUITE 200
MENLO PARK
CA
94025
US
|
Family ID: |
27084504 |
Appl. No.: |
10/071056 |
Filed: |
February 8, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10071056 |
Feb 8, 2002 |
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08789751 |
Jan 27, 1997 |
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6346077 |
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08789751 |
Jan 27, 1997 |
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08603758 |
Feb 20, 1996 |
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5894843 |
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Current U.S.
Class: |
600/204 |
Current CPC
Class: |
A61B 2017/2913 20130101;
A61B 2017/2825 20130101; A61B 17/3421 20130101; A61B 2017/00703
20130101; A61B 17/0206 20130101; A61B 17/0642 20130101; A61B
2017/0648 20130101; A61B 2017/2929 20130101; A61B 2017/00858
20130101; A61B 2017/1139 20130101; A61B 17/8076 20130101; A61B
17/02 20130101; A61B 17/12 20130101; A61B 2017/00539 20130101; A61B
17/00234 20130101; A61B 2017/0243 20130101; A61B 2017/00991
20130101; A61B 2017/349 20130101; A61B 90/00 20160201; A61B
2017/306 20130101; A61B 2017/00243 20130101; A61B 17/3423 20130101;
A61B 17/0218 20130101 |
Class at
Publication: |
600/204 |
International
Class: |
A61B 001/32 |
Claims
1. A device for use in a cardiovascular surgery on the beating
heart comprising: a means for stabilizing the beating heart
comprising a contact member shaped to engage the surface of the
beating heart.
2. The device of claim 1 wherein said contact member is attached to
a shaft means.
3. The device of claim 2 wherein said shaft means are affixed to a
stable support.
4. The device of claim 1 wherein said means for stabilizing the
beating heart are comprised of two individual contact members
having a greater overall thickness at their outer edges and a
passage therebetween.
5. The device of claim 1 wherein said contact members have a
friction material on the bottom surface.
6. The device of claim 5 wherein said friction material is
comprised of a diamond plate, nail bed, open pore foam, or textured
material.
7. The device of claim 5 wherein said bottom surface is releasably
affixed to said contact members.
8. The device of claim 5 wherein said bottom surface is provided
with a cushioning member having air or a fluid contained
therein.
9. The device of claim 1 wherein said means for stabilizing the
beating heart are a pair of substantially planar contact
members.
10. The device of claim 9 wherein said substantially planar contact
members are fixed in parallel orientation.
11. The device of claim 9 further comprising a counter contact
member affixed to an interconnecting shaft is affixed to said
contact members, wherein said counter-contact member and said
contact members are at opposite ends of a said interconnecting
shaft means affixed to said interconnecting shaft.
12. The device of claim 1 wherein said contact members have a
hollow portion containing a conformable material therein.
13. The device of claim 12 wherein said conformable material is
granular, a polymeric, or a gel.
14. The device of claim 13 wherein said contact member further
comprises a plurality of disk elements disposed within said hollow
portion of said contact member and a rigid member interconnecting
said disk elements.
15. The device of claim 1 wherein said contact member has a
plurality ports formed therein to receive the distal end of a shaft
means.
16. The device of claim 15 wherein said plurality of ports are
disposed about the periphery of the contact member and wherein said
plurality of ports are releasably connected to a single shaft
means.
17. The device of claim 15 further comprising a second shaft means
having a distal end adapted to engage said ports on said contact
members.
18. The device of claim 1 wherein said contact member is
annular.
19. The device of claim 18 wherein said annular contact member has
a fixture to receive a shaft means.
20. The device of claim 19 wherein said annular contact member has
a passage formed through the bottom surface thereof.
21. The device of claim 1 further comprising means for introducing
a positive or negative air pressure to said contact members.
22. The device of claim 21 wherein said means for introducing a
positive or negative pressure to said contact members is comprised
of a tube having a plurality of ports disposed therein.
23. The device of claim 21 wherein said contact member is further
comprised of a manifold disposed within the body of said contact
member and a plurality of ports in pneumatic connection with said
manifold.
24. The device of claim 21 wherein said contact member has a slit
in pneumatic connection with a positive or negative air pressure
source.
25. The device of claim 21 wherein said tube has a malleable
portion that is separable from said contact member and at least one
port disposed in said malleable portion.
26. The device of claim 21 wherein at least one port communicates a
positive pressure proximate to said contact members and a second
port communicates a negative pressure proximate to said contact
members.
27. The device of claim 21 wherein said positive or negative
pressure is communicated by a single tube having a distal end with
an opening proximate to said contact members and a proximal end
operably associated with a shaft means.
28. The device of claim 1 further comprising a light source
proximate to said contact members.
29. The device of claim 1 further comprising a surgical drape.
30. The device of claim 29 wherein said surgical drape is disposed
about the periphery of said contact members.
31. The device of claim 30 further comprising structural support
members affixed to said surgical drape.
32. The device of claim 29 wherein said surgical drape is affixed
to a shaft means.
33. The device of claim 32 wherein said surgical drape has a
retracted configuration wherein said drape is affixed to a shaft
means.
34. The device of claim 29 further comprising extensions attached
to said contact members and having a drape attachment means.
35. The device of claim 1 further comprising a mechanism for
attaching a source vessel to a target artery attached to said
contact members.
36. The device of claim 35 further comprising a vessel receiving
member affixed to said contact members.
37. The device of claim 36 further comprising a movable vessel
support member.
38. The device of claim 37 wherein said movable vessel support
member is mounted on a hinge and rotatable to align with said
vessel receiving member.
39. The device of claim 2 further comprising a source vessel holder
operably associated with said shaft means or said contact
members.
40. The device of claim 39 wherein said vessel retention means is
comprised of at least one clamp for gripping the distal end of a
source vessel.
41. The device of claim 1 further comprising a cannula.
42. The device of claim 41 wherein said cannula is a component of a
cannula assembly further comprising means for attaching said
cannula assembly to the chest.
43. The device of claim 41 wherein said cannula has a threaded
portion about the periphery thereof.
44. The device of claim 41 wherein said cannula is operably
associated with a cannula locking mechanism having means for
engaging adjacent ribs, and a locking mechanism to maintain said
locking mechanism in engagement with adjacent ribs.
45. A means for stabilizing the beating heart comprised of a
conical cannula having a distal end of a smaller diameter adapted
to engage said beating heart at a bottom surface thereof and a
proximal end having a larger diameter with an opening for
introducing surgical instruments to the surface of the beating
heart engaged by the distal end of said cannula.
46. The device of claim 1 wherein said contact members are formed
of a malleable material.
47. The device of claim 1 wherein said contact member is
retractable by rotation about a hinge connecting said contact
members to a shaft means.
48. The device of claim 40 wherein said contact member formed of a
material having a shape memory.
49. The device of claim 47 wherein a pair of contact members are
maintained in a retracted position in the interior of the hollow
portion of a shaft means.
50. The device of claim 49 wherein said contact members are
connected to a central shaft means by and wherein said central
shaft is movable in relation to the hollow portion of said shaft
means.
51. The device of claim 47 wherein a distal portion of each of two
contact members are affixed to a the distal end of a shaft means,
and a proximal portion of each contact member is affixed to the
distal end of a guide means.
52. The device of claim 47 wherein said contact members are affixed
to a plurality of struts at least two of which affix said contact
member to said shaft means opposite said hinge.
53. The device of claim 1 wherein said contact member is formed of
a single continuous wire.
54. The device of claim 52 wherein said single wire forms at least
one loop.
55. The device of claim 1 wherein said contact member is formed of
a helical coil.
56. The device of claim 54 wherein said helical coil is retractable
into the body of a shaft means.
57. The device of claim 54 wherein said helical coil further
comprises a spacing member disposed between the adjacent coils of
said helical coil.
58. The device of claim 1 wherein said contact member is
inflatable.
59. The device of claim 58 wherein said inflatable contact member
forms a substantially annular cuff.
60. The device of claim 59 further comprising separate contact
members disposed within the interior of said annular cuff.
61. The device of claim 58 wherein said inflatable contact member
is retracted within the hollow portion of a shaft means when
deflated.
62. The device of claim 1 when said contact members are formed of a
unitary shaft having a split portion at the distal end thereof.
63. The device of claim 62 wherein said split portion is joined at
a tip distal to said split portion.
64. The device of claim 2 wherein the length of said shaft means is
adjusted by independent motion of an internal shaft and an external
shaft.
65. The device of claim 64 wherein said shaft means has a ball
joint at the distal end thereof for positioning said contact
members.
66. The device of claim 65 wherein said ball joint is lockable by
rotation of said inner shaft.
67. The device of claim 2 wherein said shaft means has an
adjustable weight affixed thereto.
68. The device of claim 67 wherein said shaft means has a
counter-weight at a proximal portion thereof, and a fulcrum
attached to said shaft means at a point between said counterweight
and said adjustable weight.
69. The device of claim 2 wherein said contact members are attached
to said shaft means by being integrally formed from a distal
portion of a plurality of said shaft means wherein said distal
portion of said shaft means is shaped to engage the beating
heart.
70. The device of claim 69 wherein the distal ends of said
plurality of shaft means are attached by an interconnecting
member.
71. The device of claim 2 wherein said shaft means has a positive
or negative pressure source operably associated therewith.
72. The device of claim 2 wherein said shaft means has a light
source operably associated therewith.
73. The device of claim 1 wherein said contact members are further
comprised of a means for positioning epicardial tissue.
74. The device of claim 73 wherein said means for positioning
epicardial tissue is comprised of sutures attached to said
epicardial tissue and engaging said contact members.
75. The device of claim 74 wherein said sutures pass through
openings in said contact members.
76. The device of claim 73 wherein said means for positioning
epicardial tissue is comprised of open passages in said contact
members.
77. The device of claim 76 wherein said means for positioning
epicardial tissue is further comprised of a slidable member that
engages epicardial tissue in said open passages.
78. The device of claim 73 wherein said means for positioning
epicardial tissue is a functional clamp formed from crimping said
contact member about said epicardial tissue.
79. The device of claim 1 wherein said contact members are
rotatable circular rollers, wherein said rotatable circular rollers
are also a means for positioning epicardial tissue.
80. The device of claim 1 wherein a contact members is further
comprised of a frame, a spring mechanism, and a frame extension
operably connected to said frame and said spring mechanism.
81. The device of claim 80 wherein said frame extension has a
plurality of pins extending from the bottom surface thereof.
82. The device of claim 2 wherein a single shaft means is connected
to a single contact member.
83. The device of claim 82 wherein a pair of said shaft mean are
interconnected by a pivot at an intermediate point.
84. The device of claim 82 wherein the said shaft means is
adjustable along its length by continuous positioning of a first
portion of said shaft means which engages a second portion and
slides in relation thereto.
85. The device of claim 84 wherein said shaft means is further
comprised of a spring mechanism disposed between said first and
second portions of said shaft means.
86. The device of claim 1 wherein her comprising a plurality of
pins extending from the bottom surface of said contact member.
87. The device of claim 86 wherein said plurality of pins engage a
pair of contact members at a guide attached to each of said contact
members.
88. The device of claim 1 wherein said contact member is comprised
of the pair of plates having a deflected edge along one side
thereof and a shaft means affixed to the opposite side.
89. The device of claim 88 further comprising a lever member
positioned between the edge and the shaft means, and underneath
said stabilizer plate in contact with said beating heart.
90. The device of claim 89 further comprising a suture for tilting
said plate about said lever member when tension is exerted on said
suture.
91. The device of claim 1 further comprising a lockable mechanism
affixed to said contact members to depress epicardial tissue on
either side of a target vessel, wherein said lockable mechanism is
comprised of a block having a movable edge formed along one side
and which rotates about a support member, wherein said lockable
mechanism further comprises a hinge pin affixed to said block and
said contact member.
92. The device of claim 91 wherein said lockable mechanism further
comprises a locking member that fixes the position of said movable
edge.
93. The device of claim 1 wherein said means for stabilizing the
beating heart is comprised of a contact member having a shaft means
with a distal portion adapted to fit within an arteriotomy in a
target coronary artery.
94. The device of claim 93 wherein the distal portion of said shaft
means is a substantially cylindrical lumen positioned substantially
perpendicular to said shaft means.
95. The device of claim 91 wherein said substantially cylindrical
lumen has cuffs at the edges thereof for engagement with the
interior of the target artery.
96. The device of claim 1 wherein said contact member is
substantially planar and has a substantially rigid surface with a
centrally disposed opening for placement of a target artery.
97. The device of claim 96 further comprising an occluder extending
beneath the surface of the rigid surface for engagement with the
target coronary artery.
98. The device of claim 97 further comprising springed tissue
retractors comprised of a coiled spring affixed to the planar
surface of said contact member at one end at least one pin at the
opposite end for engaging epicardial tissue.
99. The device of claim 1 further comprising an artery occluder
comprised of a shaft with a blunt portion for engaging the target
artery and wherein said shaft is affixed to a connecting shaft
affixed to each of a pair of said contact members.
100. The device of claim 1 further comprising means for occluding
said target coronary artery.
101. The device of claim 1 further comprising means for occluding a
target coronary artery comprising a push bolt affixed to said
contact member and wherein said push bolt is positioned downward to
engage a target artery proximate to said contact member.
102. The device of claim 1 wherein said contact member is further
comprised of means for occluding a target artery comprised of a
roller having a portion positioned beneath said contact member.
103. The device of claim 1 wherein said contact member is further
comprised means for occluding a target artery comprised of a
movable clip affixed to said contact member, wherein said movable
clip may be positioned to occlude a target coronary artery
positioned proximate to said contact member.
104. The device of claim 2 comprising a pair of contact members and
means for occluding a target artery comprised of a movable shaft
within said shaft means, wherein the distal portion of said movable
shaft engages a target artery disposed between said contact
members.
105. The device of claim 100 wherein said means for occluding said
target artery is comprised of a flange protruding from said contact
member to permit a suture to be drawn about the flange.
106. The device of claim 105 further comprising a sliding shaft
that is traversed by said suture.
107. The device of claim 105 further comprising a movable rod
having a suture guide.
108. The device of claim 1 further comprising fixtures adapted to
receive surgical instruments.
109. The device of claim 108 wherein said fixtures are
magnetic.
110. The device of claim 2 wherein said shaft means have at least
one flexible joint.
111. The device of claim 110 wherein said flexible joint is between
said shaft means and a connecting shaft affixed to a pair of said
contact members.
112. The device of claim 110 wherein said flexible joint is between
said interconnecting shaft and said contact members.
113. The device of claim 110 further comprising a locking mechanism
at each flexible joint.
114. The device of claim 2 wherein said shaft means is a flexible,
lockable arm having a plurality of interconnecting links.
115. The device of claim 114 wherein said interconnecting links are
comprised of a ball portion and a receiving portion wherein said
ball portion fits conformably within said receiving portion and
wherein a cable passes within said interconnecting links.
116. The device of claim 114 wherein said flexible, lockable arm is
comprised of sphere joints and cylindrical tubes having a
tensioning cable passing within said interconnecting links.
117. The device of claim 114 having an inflatable internal balloon
passing within said interconnecting links.
118. The device of claim 114 wherein said flexible, lockable arm is
comprised of a plurality of curved segments interconnected by a
tensioning cable wherein each of said curved segments has an
interfacing surface having teeth adapted to engage the interfacing
surface of an adjacent curved segment to prevent rotation
therebetween.
119. The device of claim 118 further comprising bushings traversed
by said tensioning cable and shaped to fit within a recessed
portion of each of two of said interfacing surfaces.
120. The device of claim 2 wherein said shaft means is comprised of
a flexible shaft having means for fixing the position of said
flexible shaft.
121. The device of claim 119 wherein said means is comprised of a
granular material that fixes the position of said flexible shaft
rigid upon introduction of a negative pressure.
122. The device of claim 120 wherein said means is a plurality of
interconnected disks in a substantially parallel relationship
wherein the outer portion of said disks engages the inner surface
of the flexible shaft and wherein said disks are interconnected by
an internal tensioning cable.
123. The device of claim 120 wherein said means is a gel or polymer
which becomes substantially rigid upon exposure to light, heat, or
chemicals.
124. The device of claim 2 wherein said shaft means is comprised of
a plurality of adjustable links having retaining rings positioned
between said adjustable links,. and an elastomeric hydraulic medium
within said adjustable links.
125. The device of claim 124 further comprising means for exerting
a compressing force of said elastomeric hydraulic medium.
126. The device of claim 125 wherein said means is a pushrod having
a distal end engaging said elastomeric hydraulic medium.
127. The device of claim 120 wherein said flexible shaft is further
comprised of a plurality of strands contained therein and wherein
said means is a mechanism at the proximal end of said shaft means
for compressing said strands.
128. The device of claim 119 wherein said flexible shaft is further
comprised of fluid-filled lumens and wherein said means is a
fixture for sealing said lumens.
129. The device of claim 2 further comprising a fine adjustment
mechanism having a plurality of threaded cables traversing ports at
a proximal portion of a shaft means.
130. The device of claim 2 wherein said shaft means is affixed to a
stable support comprised of an access platform.
131. The device of claim 130 wherein said shaft means traverses a
ball joint affixed to said access platform.
132. The device of claim 2 wherein said shaft means is further
comprised of a spring-loaded mechanism having a spring disposed
about said shaft means wherein an end of said spring engages an
inner shaft and an opposite end of said spring engages an outer
shaft.
133. The device of claim 2 wherein said shaft means if further
comprised of a fluid-dampening mechanism having a chamber with an
internal plunger wherein said plunger has a piston with an annular
seal engaging the internal portion of said chamber.
134. The device of claim 132 wherein said spring mechanism abuts an
interconnecting shaft of said contact members at a distal end and
abuts an outer shaft at the proximal portion thereof.
135. The device of claim 2 wherein said shaft means is comprised of
an adjustable central shaft having a threaded portion, wherein
rotation of a thumbscrew at a proximal portion of said shaft means
engages the threaded portion of said central shaft.
136. The device of claim 2 wherein said shaft means is comprised of
an outer sleeve engaging a second shaft having a plurality of
splines at the exterior, wherein said outer sleeve and second shaft
surround a first internal shaft having a ball joint at the most
distal end thereof for positioning of said contact members, wherein
said first internal shaft further comprises threads to permit
adjustment by a handle.
137. The device of claim 136 further comprising a circular clip
abutting the distal portion of said outer sleeve and having inner
ridges engaging said ball joint.
138. The device of claim 2 wherein said shaft means is comprised of
a malleable shaft having passing through a fixture for attaching
said malleable shaft to a retractor.
139. The device of claim 2 wherein said shaft means is comprised of
a plurality of link members interconnected by a cable connected to
each linked member a pivotable attachment point, and wherein each
said linked members has a torsion spring connected to a hinge
displaced at the pivotable attachment points between said link
members.
140. The device of claim 2 wherein the position of said contact
members are adjustable by a plurality of positioning cables affixed
to a ball joint at the distal end of said shaft means and a
positioning handle at the proximal end of said shaft means.
141. The device of claim 140 wherein said positioning handle has a
recessed portion in the bottom thereof adapted to receive a post
extending from the proximal end of said shaft means 3.
142. The device of claim 141 wherein said shaft means is affixed to
a stable support.
143. The device of claim 2 wherein said shaft means has a pair of
curved stabilizing arms having a proximal and a distal portion
engaging a ratcheting fixture affixed to a retractor blade.
144. The device of claim 143 wherein said stabilizing arms are
comprised of a pair of curved shafts wherein the curved portion of
said shafts are intermediate to said proximal and distal ends.
145. The device of claim 2 wherein said shaft means are comprised
of a plurality of malleable shafts wherein one end of each of said
plurality of malleable shafts is affixed to a stable support and an
opposite end is affixed to a contact member.
146. The device of claim 145 wherein said proximal ends of at least
two malleable shafts are attached to opposing retractor blades and
the distal ends of said malleable shafts are attached to a contact
member.
147. The device of claim 2 further comprising an adjustable arm for
affixing said shaft means to a stable support.
148. The device of claim 147 wherein said shaft means is comprised
of a pair of parallel shafts which slide relative to an axle
contained in a tightening mechanism having a lock for tightening
said mechanism about the parallel shafts.
149. The device of claim 147 wherein said adjustable arm has an
adjustable slide mechanism allowing said shaft means to move
relative to said stable support, wherein said shaft means are
affixed to a stable support by said adjustable arm and wherein said
adjustable arm has a locking mechanism.
150. The device of claim 147 wherein said adjustable arm is
comprised of a ball joint traversed by said shaft means, a
tightening shaft for fixing the position of said ball joint, and a
locking mechanism for fixing the position of the shaft means
relative to said stable support.
151. The device of claim 2 wherein said shaft means is comprised of
upper and lower dual shaft members wherein said upper dual shaft
members are attached to said lower dual shaft members by an elbow
joint wherein the attachment point of said upper and lower shaft
members is a hinge in the body of said elbow joint, and wherein
said lower dual shaft members are affixed to said contact
member.
152. The device of claim 2 wherein said shaft means is comprised of
a plurality of individual shaft members connected by horizontal
rotating joints wherein a proximal portion of said shaft means is
affixed to a retractor blade and a distal portion is affixed to a
vertical shaft.
153. The device of claim 2 wherein said shaft means are affixed to
a retractor for adjustable positioning of said shaft means relative
to a retractor blade.
154. The device of claim 153 wherein said shaft means is comprised
of a lower shaft concentrically oriented within an upper shaft and
locking means for fixing the position of the lower shaft relative
to the upper shaft, wherein a proximal portion of said upper shaft
is affixed to a retractor blade.
155. The device of claim 153 wherein a plurality of adjustable
shafts have a distal end affixed to a contact member and a proximal
end affixed to a retractor blade.
156. The device of claim 153 wherein said shaft means is comprised
of a lockable, rotatable arm having a first hinge for rotation of
said arm relative to said retractor blade and a second hinge for
vertical positioning of said rotatable arm relative to said
retractor blade.
157. The device of claim 153 wherein said shaft means has an
adjusting knob affixed to a proximal end and a telescoping shaft
member extendable from said retractor blade and having a contact
member affixed to the distal end thereof.
158. The device of claim 153 wherein said shaft means is comprised
of a flexible central shaft having a handle at one end, wherein
said flexible shaft traverses a series of shaft guides wherein and
wherein the distal portion of said flexible central shaft is
affixed to said contact member.
159. The device of claim 158 wherein the most proximal shaft guide
is affixed to the cross member of a retractor.
160. The device of claim 158 wherein said shaft guides have a
predetermined curve to fix the position of said central shaft.
161. The device of claim 2 wherein said shaft means traverses the
body of a retractor and is held in place by an upper plate and a
lower plate wherein said upper and lower plate engage a sphere
traversed by said shaft means.
162. The device of claim 2 wherein said shaft means if comprised of
a curved shaft extending from a cross-arm of a retractor, wherein
said curved shaft extends from said cross-arm and has a length
sufficient to extend below the position of said retractor blades,
and wherein the distal portion of said shaft has substantially
horizontal shaft attached to said contact member.
163. The device of claim 2 wherein said shaft means is affixed to a
rib locking mechanism, wherein said rib locking mechanism provides
a stable support for said shaft means, and wherein said rib locking
mechanism is comprised of adjustable posts engaging opposite sides
of a rib proximate to a surgical incision.
164. The device of claim 163 wherein said rib locking mechanism is
comprised of a post that is slidably engaged within a slot formed
in said rib locking mechanism and that is positioned by a locking
latch.
165. The device of claim 2 wherein said shaft means is comprised of
a hollow unitary shaft wherein the bottom surface of said unitary
shaft engages the beating heart.
166. The device of claim 165 wherein said hollow shaft has a lower
cylindrical portion that splits into semi-cylindrical portions.
167. The device of claim 165 further comprising a plurality of
openings in the body of the hollow shaft.
168. The device of claim 165 wherein a pair of said contact members
are formed from the body of said hollow shaft and are rotatable
away from said body by a hinge.
169. The device of claim 165 wherein said hollow shaft has an
annular ring formed in the bottom portion of said hollow shaft, and
wherein said annular ring rotates about a movable rod to abut a
target artery.
170. The device of claim 169 wherein said annular ring has at least
one passage formed in said annular ring for positioning of a target
coronary artery therein.
171. The device of claim 1 wherein said means for stabilizing the
beating heart is comprised of an elongated sheath member.
172. The device of claim 171 wherein said elongated sheath member
has a plurality of support attachments that are air or
fluid-filled.
173. The device of claim 172 wherein said support attachments have
a lumen for providing air or fluid.
174. The device of claim 171 wherein said elongated sheet is
affixed to a crank at either end.
175. A means for positioning the beating heart comprising a
substantially flat, flexible sheet, having one side coated with a
hydrogen-like material for adherence to an epicardial surface.
176. The device of claim 175 wherein said sheet is a two-sided
structure having an interstitial space therebetween for perfusion
of a fluid.
177. The device of claim 2 wherein said shaft means is comprised of
a plurality of telescoping shafts having a distal end affixed to a
contact member and a proximal end affixed to hydraulic
actuator.
178. The device of claim 177 wherein each of said hydraulic
actuators is attached to a retractor blade and is affixed to a
hydraulic hose for remote actuation by a hand-activated switch.
179. The device of claim 2 wherein said shaft means is comprised of
a plurality of arms connected by friction joints.
180. The device of claim 179 wherein said friction joints are
comprised of an upper and lower housing surrounding a ball joint
wherein one of said upper and lower housing has a friction surface
disposed therein and the opposite housing has a friction engaging
means positioned to engage the friction surface.
181. The device of claim 179 further comprising a rotatable shaft
means having a central rod located within a housing and tongue
forming a ratchet mechanism to fix the position of the rotatable
shaft means.
182. The device of claim 181 wherein said rotatable shaft means are
affixed to contact members by a hinge.
183. The device of claim 179 further comprising a locking mechanism
attaching said shaft means to a retractor blade, wherein said
locking mechanism is released by an internal cam shaft actuated by
a handle.
184. The device of claim 2 wherein said shaft means is comprised of
a flexible slide having a contractible shaft at the distal end
thereof wherein said contractible shaft is attached to a contact
member, and wherein said flexible slide is shaped to be inserted
into a clip attached to a retractor blade.
185. The device of claim 184 further comprising hydraulic tubing
containing fluid to extend said contractible shaft.
186. The device of claim 1, 2, 3, 29, 35, 39, 41, 93, or 153
wherein said means for stabilizing the beating heart is disposable
and contained in a sterilized package.
187. The device of claim 175 wherein said means for positioning the
beating heart is disposable and contained in a sterilized
package.
188. The device of claim 1, 2, 3, 29, 35, 39, 41, 93, or 153
wherein said means for stabilizing the beating heat is sterilized
and completely enclosed within a container that prevents
contamination by microorganisms.
189. The device of claim 175 wherein said means for positioning the
beating heart is sterilized and completely enclosed within a
container that prevents contamination by microorganisms.
Description
[0001] Diseases of the cardiovascular system affect millions of
people each year and are a leading cause of death throughout the
world. The costs to society from such diseases is enormous both in
terms of the lives lost and in terms of the cost of treating
patients through traditional surgical techniques. A particularly
prevalent form of cardiovascular disease is a reduction in the
blood supply leading to the heart caused by atherosclerosis or
other condition that creates a restriction in blood flow at a
critical point in the cardiovascular system that supplies blood to
the heart. In many cases, such a blockage or restriction in the
blood flow leading to the heart is treated by a surgical procedure
known as a Coronary Artery Bypass Graft (CABG) procedure, which is
more commonly known as a "heart bypass" operation. In the CABG
procedure, the surgeon "bypasses" the obstruction to restore normal
blood flow to the heart by attaching an available source vessel to
an obstructed target coronary artery or by removing a portion of a
vein or artery from another part of the body, to use as a graft,
and by installing the graft at points between a source vessel and a
target artery to restore normal blood flow.
[0002] Although the CABG procedure has become relatively common,
the procedure itself is lengthy and traumatic and can damage the
heart, the cardiovascular system, the central nervous system, and
the blood supply itself. In a conventional CABG procedure, the
surgeon must make a long incision down the center of the chest, cut
through the entire length of the sternum, perform several other
procedures necessary to attach the patient to a heart-lung bypass
machine, cut off the blood flow to the heart, and then stop the
heart from beating in order to complete the bypass. The most
lengthy and traumatic surgical procedures are necessary, in part,
to connect the patient to a cardiopulmonary bypass (CPB) machine to
continue the circulation of oxygenated blood to the rest of the
body while the bypass is completed.
[0003] Although several efforts have been made to make the CABG
procedure less invasive and less traumatic, most techniques still
require cardiopulmonary bypass (CPB) and cardioplegia (stopping the
heart). The safety and efficacy of the CABG procedure could be
improved if the surgeon could avoid the need to stop the heart from
beating during the procedure, thereby eliminating cardiopulmonary
bypass and the lengthy and traumatic surgical procedures necessary
to connect the patient to a cardiopulmonary bypass machine to
sustain the patient's life during the procedure. In recent years, a
small number of surgeons have begun performing CABG procedures
using surgical techniques especially developed so that the CABG
procedure could be performed while the heart is still beating. In
such procedures, there is no need for any form of cardiopulmonary
bypass, no need to perform the extensive surgical procedures
necessary to connect the patient to a cardiopulmonary bypass
machine, and no need to stop the heart. As a result, the surgery is
much less invasive and the entire procedure can typically be
achieved through a small number, typically one or two,
comparatively small incisions in the chest.
[0004] Despite the advantages, the beating-heart CABG procedure is
not widely practiced, in part, because of the difficulty in
performing the necessary surgical procedures using conventional
surgical instruments. If specially designed instruments were
available so that the CABG procedure could be performed on the
beating heart, the beating-heart CABG procedure would be more
widely practiced and the treatment of cardiovascular disease in a
significant patient population would be improved.
[0005] As noted above, the CABG procedure requires that a fluid
connection for restoring the flow of blood be established between
two points to "bypass" a diseased or obstructed area to restore
blood flow to the heart. This procedure is known as an
"anastomosis." Typically, a source vessel, such as a source artery
with an unobstructed blood flow, i.e., the left internal mammary
artery (LIMA), or a bypass-graft having one end sewn to an
unobstructed blood source such as the aorta, is sewn to a target
occluded coronary artery, such as the left anterior descending
(LAD) artery or other vessel, that provides blood flow to the
muscles of the heart. Because the beating-heart CABG procedure is
performed while the heart muscle is continuing to contract and pump
blood, the anastomosis procedure is difficult to perform because
the heart continues to move while the surgeon is sewing the
anastomosis.
[0006] The specific part of the surgical procedure that creates the
anastomosis in the beating-heart CABG procedure requires placing a
series of sutures through extremely small vessels on the surface of
the heart and requires completing the anastomosis while the heart
muscle continues to beat to pump blood during the procedure.
Moreover, the sutures must be carefully placed so that the source
vessel or graft is firmly attached when the anastomosis is complete
and does not leak when blood flow through the vessel is
established. It is also important that the anastomosis procedure be
performed rapidly because the blood flow through the target
coronary artery may be temporarily interrupted or reduced to avoid
excessive blood loss. Also, the working space and visual access are
limited because the surgeon may be working through a small incision
in the chest or may be viewing the procedure on a video monitor if
the site of the surgery is viewed via a surgical scope.
[0007] In one current practice, the surgeon places sutures through
the heart tissue and, by exerting opposing tension on the sutures,
stretches the tissue surrounding the site of the anastomosis to
partially reduce the motion of the heart while the anastomosis is
completed. This approach is far from ideal. Alternatively, a
suction device may be attached to the surface of the heart to fix
the motion of the outer layer of surface tissue. In such cases, a
suction device typically has several ports incorporated into an
instrument that may be attached to the heart to apply a negative
pressure to the surface tissue. The negative pressure essentially
attaches the surface tissue to the apparatus thereby fixing the
position of a portion of the surface of the heart. Such devices are
described in co-pending U.S. patent application Ser. No.
603,328.
[0008] While the negative pressure approach may be effective in
fixing a portion of the surface tissue of the heart, the negative
pressure applied to cardiac tissue can result in temporary
hematomas at the site where the suction ports attach to the tissue.
Also, the exterior cardiac tissue is fixed in a configuration
defined by the shape of the instrument and the orientation of the
suction ports. While the heart continues to beat, the heart muscles
are contracting to pump blood, which results in the muscles
exerting a force directed away from the exterior tissue fixed by
suction.
[0009] The beating-heart CABG procedure could be greatly improved
if the heart could be stabilized during the procedure such that the
motion of the heart, particularly at the site of the anastomosis,
is mininized even though the heart continues to beat to supply
blood to the body. If effective means for stabilizing the beating
heart were available, the beating-heart CABG procedure could be
performed more easily, more rapidly, more safely, and with less
trauma to the patient.
SUMMARY OF INVENTION
[0010] The advantages provided to a surgeon by the instruments and
techniques of the invention allow the beating heart CABG procedure
to be performed more rapidly, with less trauma to the patient, and
enable a surgeon to perform a CABG procedure without CPB or
cardioplegia. This invention provides an alternative approach to a
suction apparatus by providing devices and methods for stabilizing
the motion of the heart using mechanical instruments specially
designed to apply a stabilizing force to the heart to minimize the
motion of the beating heart during a surgical procedure. The
invention enables a surgeon to readily and rapidly perform a
beating-heart CABG procedure thus avoiding the need for
cardioplegia or cardiopulmonary bypass. In particular, the methods
and devices described herein enable the surgeon to stabilize the
heart such that an anastomosis can be more readily accomplished by
enabling the surgeon to attach a source vessel or bypass graft to a
target coronary artery whose motion is minimized for the duration
of the surgical procedure.
[0011] Pursuant to the invention, a stabilizing device is
introduced through a suitable opening in the chest that provides
access to the beating heart. By contacting the heart with the means
for stabilizing the beating heart of this invention, and by
exerting a stabilizing force on the heart, the motion of the heart
caused by the contraction of the heart muscles is effectively
eliminated such that movement of the target artery at the site of
the anastomosis is minimized. The remainder of the heart may be
allowed to contract normally or may have additional devices in
place to support the heart or to restrain its motion. Additionally,
several of the devices of the invention may be used to position the
beating heart to provide an improved surgical field, to maintain
the heart in a preferred configuration for surgery, or to rotate
the heart to present distinct features of the heart to the
surgeon's visible and accessible surgical field.
[0012] An important advantage of this invention is derived from the
discovery that a new and effective technique can be described
herein and performed in surgery using the devices of the invention
to provide an advantageous technique for stabilizing or positioning
the beating heart during a surgical procedure. The procedure for
stabilizing the beating heart generally requires exerting a
stabilizing force on the beating heart using devices constructed as
described herein. Typically, in separate steps, the surgeon
contacts the heart with at least one component of the means for
stabilizing the beating heart of this invention, assesses the
degree of movement of the heart, particularly at the site of the
surgery, and positions the component of the stabilizing means
proximate to the site of the surgery such as a target coronary
artery of an anastomosis. With the functional portion of a
stabilizing means in place, the surgeon applies a stabilizing force
to the beating heart such that the portion of the instrument in
contact with the surface of the heart displaces the surface of the
heart a sufficient distance that the contraction of the heart does
not cause substantial motion, either vertical or horizontal, at the
surgery site. The stabilizing force is applied directly or
indirectly using at least one component of the stabilizing means of
the invention and is comprised of exerting a mechanical force onto
the beating heart, generally at a specific location such as a
target coronary artery and generally exerting force that is at
least partially applied in a direction perpendicular to the surface
of the beating heart. Thus, an important aspect of this invention
is the discovery that the beating heart may be effectively
stabilized for the purpose of a surgical procedure by using a
specially designed instrument as described herein to exert a
mechanical stabilizing force on the exterior of the heart,
particularly where the force is exerted proximate to the site of
the surgery. The stabilizing force may consist of a force that
resists the motion supplied by the beating heart, or additional
forces applied to the heart, or the stabilizing force.
[0013] By fixing the position of the stabilizing means in a
configuration where the motion of the beating heart is effectively
eliminated, the surgeon maintains the stabilizing force on the
beating heart for the duration of the procedure. To fix the
position of the means for stabilizing the beating heart, the
stabilizing means may be attached to a retractor used to separate
the ribs or to another fixed support. The stabilizing means may
also be attached to a comformable, flexible, or semi-rigid arm or
shaft means which is rendered substantially rigid mechanically,
chemically, or by human intervention. In certain preferred
embodiments, the stabilizing means has an adjustable shaft means
which may be oriented in several directions and has a fixture
adapted to be attached to a retractor. In a preferred technique of
the invention, the surgeon first performs a thoracotomy and
retracts the ribs using a retractor, which may then be locked in an
open position providing access to the beating heart. The surgeon
then contacts the surface of the heart with a component of the
stabilizing means, which has been provided with an adjustable
shaft, at a point proximate to the target coronary artery, and
exerts a stabilizing force on the means for stabilizing the beating
heart. By manipulating the adjustable shaft, the site of the
surgery will become substantially motionless. This force may be
advantageously applied, and the absolute amount of force minimized
with the additional feature of an adhesive or high-friction surface
on the component of the stabilizing means that contacts the beating
heart. At this point, the adjustable shaft means is fixed in
position, for example by being stably attached to the retractor,
thereby rendering the target coronary artery substantially
motionless for the duration of the procedure.
DESCRIPTION OF THE FIGURES
[0014] FIG. 1 is a means for stabilizing the beating heart having a
pair of substantially planar contact members which are oriented to
engage the heart proximate to the site at which a bypass will be
sewn.
[0015] FIG. 1 also shows the contact members attached to a shaft
means which may be adjustable in several directions and which may
be attached to a retractor or other fixed support structure.
[0016] FIG. 1A is a detail of the shaft means and the structure of
the adjustable positioning mechanisms.
[0017] FIGS. 1B through 1G are various configurations of a contact
member having a friction means which is preferably affixed to the
bottom surface of the contact member.
[0018] FIG. 2 is an example of a snap-on member affixed to the
bottom surface of a contact member for ease of manufacture and
disposability advantages.
[0019] FIG. 3 is an example of a stabilizing means of the invention
having an inflatable or fluid-filled cushioning member disposed
between the bottom surface of the contact member and the surface of
the beating heart.
[0020] FIGS. 4A through 4C are an embodiment of the invention
having weighted contact members that engage the beating heart, and
which may be part of a system to achieve stabilization of the heart
by applying a stabilizing force via a balanced mass having an
adjustable weight and counterweight configuration.
[0021] FIG. 4A shows the weighted contact member in cross
section.
[0022] FIG. 4B is the contact members having an opening disposed
therebetween for positioning of a vessel.
[0023] FIG. 4C shows the contact member coupled to a shaft that is
affixed to a fulcrum having an adjustable weight and a
counter-weight.
[0024] FIG. 5 is an embodiment of the invention having a
counter-contact member positioned opposite a pair of contact
members and having a shaft positioned at an intermediate point
therebetween.
[0025] FIGS. 6A and 6B are embodiments of the invention having
contact members which have a conformable shape, and where a
flexible or semi-rigid member may be passed through the body of the
contact member.
[0026] FIG. 7A is an embodiment of the contact member wherein the
contact member has ports for releasable attachment of the distal
end of a shaft means.
[0027] FIG. 7B is an embodiment wherein a plurality of ports are
disposed about the periphery of a contact member for releasable
attachment to the distal end of a shaft means.
[0028] FIG. 7C is an embodiment of the invention wherein a separate
shaft is provided having distal portions adapted to fit within
ports on a contact member.
[0029] FIGS. 7D and 7E are an embodiment of the invention wherein
the contact members are formed from the distal portion of a shaft
means for minimally invasive applications.
[0030] FIG. 7E shows an interconnecting member for joining the
distal portions of the shaft means.
[0031] FIG. 8 is an embodiment of the invention having a
substantially annular contact member which is affixed to a shaft
which is rotatable about the annular contact member and which may
be locked into position at a given point about the periphery of the
contact member.
[0032] FIGS. 9A through 9G are embodiments of the invention where a
positive or negative pressure is provided proximate to the contact
members.
[0033] FIG. 9H is an embodiment of the invention where a light
source is provided to illuminate the area that the beating heart
contacted by the contact members.
[0034] FIGS. 10A through 10C are embodiments of the invention where
a surgical drape is operably associated with the contact members to
provide an isolated visual field.
[0035] FIG. 11 is the contact members of the invention having an
associated apparatus to facilitate completing the anastomosis.
[0036] FIG. 12 is an embodiment of the invention where the shaft
means has associated therewith a separate vessel holder.
[0037] FIGS. 13A through 13E are a cannula assembly preferred for
providing minimally invasive access for the stabilizing means of
the invention.
[0038] FIG. 13A has screws for attaching the cannula assembly to
the chest wall.
[0039] FIG. 13B has a threaded portion about the periphery of the
cannula.
[0040] FIGS. 13C through 13E are a locking mechanism designed to
engage adjacent ribs.
[0041] FIG. 14 is a conical cannula having a smaller distal end to
engage the surface of the beating heart and a larger proximal
opening for introducing surgical instruments to the beating
heart.
[0042] FIGS. 15A and 15B are an embodiment of the invention
inserted through the chest wall in a minimally invasive fashion via
a cannula to bring the contact members into engagement with the
beating heart.
[0043] FIGS. 16A through 16E are an embodiment of the invention
design for minimally invasive insertion and removal of flexible
contact members whereby the contact members are maintained in a
retracted state within a hollow portion of a shaft and are deployed
upon extension of a central shaft.
[0044] FIGS. 17A through 17D are an additional embodiment providing
minimally invasive insertion and removal of the contact members of
the invention whereby individual contact members are rotated into
position by a hinge at the distal end of a shaft.
[0045] FIGS. 18A through 18D are contact members which are attached
to a guide that is positioned about a shaft such that downward
movement of the guide causes the contact members to be
deployed.
[0046] FIGS. 19A and 19B are contact members of the invention
attached to a shaft means by a plurality of struts that extend the
contact members into position.
[0047] FIGS. 20A through 20E are contact members of the invention
that are rotatable about the distal portion of a shaft means by a
plurality of hinges.
[0048] FIGS. 21A through 21C are an embodiment having contact
members formed from a unitary wire which is looped such that when
extended from a body of the device, the contact members are
deployed, and may be removed in a minimally invasive fashion by
withdrawing a portion of the wire into the body of the device.
[0049] FIGS. 22A through 22C are an embodiment of the invention
wherein the contact members are formed from a helical coil which
may be withdrawn into the hollow portion of a shaft for minimally
invasive insertion and removal.
[0050] FIGS. 23A and 23B are inflatable contact members that may be
deflated for insertion or removal by being drawn into the body of a
shaft.
[0051] FIGS. 24A and 24B are a contact member of the invention
formed from an inflatable annular cuff.
[0052] FIGS. 25A and 25B are contact members formed from the
divided portion of the distal end of a shaft.
[0053] FIGS. 26A through 26C are contact members having sutures
associated therewith for manipulation of a target artery.
[0054] FIGS. 27A and 27B are an intravessel stabilizer adapted to
fit within the target coronary artery.
[0055] FIGS. 28A and 28B are contact members of the invention
having means associated therewith for positioning said epicardial
tissue.
[0056] FIGS. 29A and 29B are contact members of the invention
having rotatable cylindrical rollers for collecting or spreading
epicardial tissue proximate to a target artery.
[0057] FIG. 30 is a means for stabilizing the beating heart having
a pair of contact members which are additionally comprised of a
spring-tensioned frame having an extension that engages and spreads
the tissue at the site of the surgery to better expose the coronary
artery.
[0058] FIGS. 31A and 31B are embodiments of the stabilizing means
having a single shaft means associated with each contact member and
where the shaft means are interconnected and can be moved
independently about a pivot such that the contact members spread
the surface tissue of the heart proximate to the target coronary
artery to increase exposure of the target artery at the site of the
anastomosis.
[0059] FIGS. 32A through 32C are embodiments of the invention
wherein the contact members have additional structures associated
therewith for retraction of epicardial tissues the epicardial
retractors may be comprised of pins which extend from the bottom
surface of the contact member.
[0060] FIGS. 33A and 33B are means for stabilizing the beating
heart comprising a system which incorporates the retractor which
spreads the ribs to provide surgical access to the heart. The
stabilizing means is comprised of a pair of stabilizing plates
which may be used together with a lever device to improve exposure
of the target coronary artery.
[0061] FIGS. 34A through 34D are an embodiment of the invention
having a lockable mechanism for depressing epicardial tissue on
either side of a target coronary artery.
[0062] FIG. 35 is a substantially planar stabilizing platform which
contacts the heart at a site proximate to and surrounding the
coronary vessel. The platform may also have associated therewith at
least one occluder which restricts or eliminates blood flow through
an artery and an associated device for spreading the tissue
proximate to the anastomosis.
[0063] FIG. 36 is an artery occluder comprised of a shaft portion
and having a blunt portion to engage a target artery.
[0064] FIGS. 37A through 37C are contact members having structures
associated therewith for occluding the target coronary artery.
[0065] FIGS. 38A and 38B are contact members of the invention
having a flange associated therewith for use with sutures that
surround the target vessel and may be used in connection with a
movable shaft or suture guide to occlude the target vessel.
[0066] FIG. 39 is an embodiment of the contact member of the
invention having one or more fixtures attached, preferably to a
planar surface thereof, and adapted to receive a surgical tool or
accessory such as scissors, forceps, or surgical needles for the
convenience of the surgeon during the anastomosis procedure.
[0067] FIG. 40 is an embodiment of the invention having flex joints
between the contact members, the interconnecting shaft, or the
shaft means to provide continuous positioning of the contact
members.
[0068] FIG. 41 is an embodiment of the invention having lockable
joints associated with the shaft means.
[0069] FIG. 42 is a flexible, lockable arm which allows positioning
in every direction to place and orient the contact members until
the requisite degree of stabilization is achieved at which point
the arm having a stabilizing means is fixed in position. The
flexible, lockable arm may be attached to a retractor and is caused
to become rigid when the entire stabilizing means is properly
positioned.
[0070] FIG. 43 is a conformable, lockable arm having hollow
cylinders and spheres and an inflatable balloon member disposed
therein to lock the arm into position.
[0071] FIGS. 44A and 44B are embodiments of the invention having
curved interlocking segments wherein teeth formed at the
interconnecting surfaces of each segment prevent rotation of the
respective segments.
[0072] FIGS. 45A and 45B are a flexible shaft having means
incorporated therein for fixing the position of the shaft.
[0073] FIGS. 46A through 46C are an embodiment of the invention
where a series of adjustable links have a elastomeric hydraulic
median disposed therein and where application of force causes the
elastomeric hydraulic median to become rigid and fixes the position
of the adjustable links.
[0074] FIG. 47 is an embodiment of the invention having a flexible
shaft with a plurality of strands located therein wherein locking
the strands in position at a distal portion causes the shaft to
become rigid.
[0075] FIG. 48 is a flexible shaft having a plurality of lumens
disposed therein such that sealing of the lumens fixes the position
of the flexible shaft.
[0076] FIG. 49 is a fine adjusting mechanism wherein a plurality of
treaded cables are attached to a proximal portion of a shaft means
whereby turning the threaded cables causes the proximal portion of
the shaft means to be adjusted.
[0077] FIGS. 50A and 50B are embodiments of the shaft means having
spring-loaded or air-damping mechanisms to restrict the vertical
motion of the shaft relative to a stable support.
[0078] FIGS. 51A and 51B are shaft means of the invention provided
with fine adjustment mechanisms for vertical positioning of the
shaft.
[0079] FIG. 52 is a malleable shaft that is mounted on a fixture
attached to a retractor blade and having a handle for vertical
positioning of the shaft.
[0080] FIG. 53 is a shaft means comprised of an adjustable arm
formed from several interlocking segments attached to a cable.
[0081] FIGS. 54A through 54C are an adjustable shaft means of the
invention wherein the position of the contact members are adjusted
by a positioning handle located at the proximal portion of the
shaft means and connected to a ball joint at the distal portion by
a plurality of positioning wires.
[0082] FIG. 55A is an embodiment of the stabilizing means of the
invention having stabilizer bars suspended from the bottom side of
a rib retractor wherein the stabilizer bars engage a ratchet
means.
[0083] FIG. 55B has malleable shafts attached to a retractor and to
the contact members.
[0084] FIGS. 56A through 56D are a shaft means of the invention
having mechanisms for adjustable positioning of the shaft relative
to a stable support.
[0085] FIG. 57 is an adjustable arm for attaching a shaft means of
the invention to a stable support wherein the shaft means passes
through a ball joint that is adjustable by a fixture on the arm and
wherein the arm is locked in place on the stable support by a latch
mechanism.
[0086] FIGS. 53A through 58C are embodiments of the shaft means of
the invention for adjustable positioning of the shaft means
relative to a retractor blade.
[0087] FIGS. 59A through 59C are adjustable shaft means of the
invention that extend from a retractor blade or a retractor arm and
are continuously positioned relative to the retractor blade or
retractor arm.
[0088] FIG. 60 is an embodiment having a central shaft with a
handle at the proximal end that is positioned by a plurality of
shaft guides which are preferably attached to a interconnecting arm
affixed to a retractor.
[0089] FIG. 61 is an embodiment of the stabilizing means of the
invention having a pair of plates operably associated with a rib
retractor and a sphere disposed between the plates to facilitate
orientation of the shaft means.
[0090] FIG. 62 is an embodiment of the invention having a shaft
means comprised of an arm which extends from the interconnecting
bar of a retractor to a position below the retractor blades and has
a substantially horizontal shaft.
[0091] FIG. 63 is the means for stabilizing the beating heart of
the invention operably associated with a rib locking mechanism.
[0092] FIG. 64 is the stabilizing means of the invention adapted to
be used as a means for positioning the beating heart, wherein the
means are operably associated with a rib locking mechanism.
[0093] FIGS. 65A through 65D are embodiments of the invention where
the shaft means is comprised of a unitary hollow shaft.
[0094] FIG. 66 is a means for stabilizing the beating heart having
a sheath member with several pliable support attachments associated
therewith which may include or be comprised of inflatable members
which are positioned at one or several locations surrounding the
heart and may have a lumen disposed within the sheath member for
the introduction of air or a biocompatible fluid.
[0095] FIG. 67 is a stabilizing means formed from a movable sheath
member that is attached at either end to cranks mounted on the arms
of a retractor.
[0096] FIGS. 68A through 68C are a device for advantageous
positioning of the heart comprised of a flexible sheet, preferably
having a hydrogel coating on one side.
[0097] FIG. 69 is an embodiment of the invention comprised of a
plurality of telescoping shafts having the contact member affixed
at their distal end and wherein the position of the telescoping
shaft is manipulated and fixed by a hydraulic actuators.
[0098] FIGS. 70A through 70D are an embodiment of the invention
having a conformable arm comprised of a plurality of friction
joints that are engaged when the motion of the beating heart
presses against the contact member.
[0099] FIGS. 71A through 71D are an embodiment of the invention
having a contractible shaft attached to a flexible slide. The
flexible slide is designed to be inserted into a seed-shaped clip
which may be attached to a retractor blade. The contractible shaft
is extended to engage the beating heart by application of hydraulic
pressure, for example, by a syringe that is preferably supplied
with a one-way releasable valve.
[0100] FIG. 72 is a view of the interior of the chest cavity during
a CABG procedure on the beating heart with the stabilizing means
operably associated with a retractor and being used in conjunction
with other surgical apparatus to facilitate completing the
anastomosis.
[0101] FIGS. 73 and 74 show the stabilizing means of the invention
having been introduced through a thoracotomy to contact the beating
heart to engage the heart tissue on either side of a target
coronary artery to which an anastomosis is sewn.
[0102] FIG. 75 is an embodiment of the invention having a pair of
shaft means operably associated with ball joints that are affixed
to opposing arms of a retractor.
DETAILED DESCRIPTION OF THE INVENTION
[0103] This invention is surgical instruments for stabilizing the
beating heart and methods for their use. The means for stabilizing
the beating heart are comprised of several alternative structures
at least one component of which engages the surface of the heart to
stabilize the beating heart during coronary surgery. The
instruments provide the capability to exert and maintain a
stabilizing force on the heart by contacting the heart with a
component of the stabilizing means and by functionally fixing the
position of the stabilizing means throughout the duration of a
surgical procedure.
[0104] The instruments and methods of the invention are preferably
used for stabilization of the beating heart during a minimally
invasive coronary artery bypass graft (CABG) operation which has
been specially developed to facilitate completion of an
anastomosis, to a target coronary artery for example by the
placement of a bypass graft or the connection of a source artery,
without requiring cardiac arrest such as cardioplegia or
fibrillation and without cardiopulmonary bypass (CPB). Although the
means for stabilizing the beating heart can be applied in different
surgical contexts, the devices described herein are most
advantageously employed in a CAEG procedure wherein only one or two
minimally invasive incisions are placed in the chest. The complete
structure of the stabilizing means of the invention may be provided
by any of several structural embodiments which stabilize the
beating heart while the minimally invasive surgical procedure is
performed. Discrete components of the stabilizing means may also
advantageously function in a multiple component system containing a
retractor, an occluder, a surgical blower or suction device, an
apparatus for holding the source artery, such as a LIMA holder, or
other like discrete or integrated surgical devices or instruments
that enable a surgeon to more efficiently complete the anastomosis.
While the devices disclosed herein each use mechanical means to
stabilize the beating heart, certain embodiments are designed to
operate on the entire heart while others have a more localized
effect and may be applied to the area immediately proximate to a
structure such as the target artery of the anastomosis. In each
instance, the beating heart is effectively stabilized at the area
where a surgical procedure is to be performed.
[0105] Surgical access to the beating heart may be achieved by
several conventional surgical procedures which have been developed
for traditional cardiac bypass surgery and the surgeon may thereby
obtain the advantages provided by this invention in any procedure
where the bypass is achieved on the beating heart without regard to
the surgical method of access to the heart. Preferably, the surgeon
takes additional measures to restrict the movement of the entire
heart within the chest cavity and may utilize certain embodiments
disclosed herein to position or orient the beating heart. For
example, an adjustable strap which may have inflatable cushions
attached to the straps, or having laces may be inserted beneath or
surrounding the heart. When access to the beating heart is achieved
by a sternotomy, at least part of the length of the sternum is
divided to expose the surface of the heart. Additionally, when the
pericardium is available, the pericardium may be incised and used
to position the beating heart. When available, the surgeon can use
the pericardium to raise and rotate the beating heart within the
chest cavity and maintain the position by suturing the pericardium
to the periphery of the incision.
[0106] In a preferred embodiment, minimally invasive access to the
beating heart is achieved by a thoracotomy, which is usually
created in the left side of the chest by a smaller incision between
the ribs, followed by insertion of a retractor between the ribs,
spreading of the ribs, and securing the retractor in an open
position to provide access to the source vessel and the target
coronary artery. The use of the pericardium to position the beating
heart as described above is particularly advantageous when the less
invasive thoracotomy is used to provide access to the heart. In
this procedure, an incision is created in the pericardium, which is
then sutured to the periphery of the thoracotomy. In this
configuration, the pericardium acts as a restraining sack to keep
the beating heart in a desired orientation to achieve the
anastomosis.
[0107] Once access to the heart is achieved, and the heart is
positioned if necessary, the means for stabilizing the beating
heart is introduced through the opening created by the thoracotomy
and at least one component of the stabilizing device of the
invention is brought into contact with the beating heart. The
surgeon then applies a stabilizing force to the beating heart via
the stabilizing means which may then be fixed in place by
attachment to a fixed support. When the rib retractor or platform
is fixed in an open position to expose the heart, the retractor
platform may also provide the stable support structure to which the
stabilizing means is affixed. When the position of the stabilizing
means is fixed by attachment to a stable support or to the
retractor platform, the stabilizing force is maintained for the
duration of the procedure.
[0108] Although the particular source vessel and target artery of
the anastomosis are determined clinically, a common minimally
invasive bypass procedure on the beating heart includes an
anastomosis which forms a connection between the left internal
mammary artery (LIMA) as the source artery, and the left anterior
descending artery (LAD) as the target artery. The LIMA to LAD
anastomosis is used as an example herein but it is readily
appreciated that the techniques and instruments described herein
may be applied to other procedures depending on the clinical
diagnosis and a patient's anatomy. To complete the anastomosis, the
surgeon must dissect a portion of the LIMA by separating it from
the internal chest cavity. Once dissection of the LIMA is achieved,
the surgeon may attach the dissected LIMA to the target coronary
artery, i.e., the LAD. In this example, the stabilizing means of
this invention would be used to stabilize the beating heart during
at least the portion of the procedure during which the surgeon
completes the anastomosis of the LIMA to the LAD.
[0109] The structure of the portion of the stabilizing means which
contacts the heart may include one or more contact members which
exert a stabilizing force on the heart proximate to the site of the
anastomosis. A pair of contact members may be plates or rectangular
members which are placed on either side of the target coronary
artery at the site of the anastomosis and which may have friction
means or tissue spreading or compressing apparatus associated
therewith. The contact members may also be provided by a platform
which may be substantially planar or which may be contoured to fit
conformingly on the surface of the heart. The stabilizing means may
also include a shaft means having several alternative embodiments
to facilitate adjusting the position and orientation of the
instrument. For example, the shaft means may have an adjustable
length and the axis of the shaft means may have at least one ball
joint disposed within its length such that the orientation of the
shaft means relative to another structure such as the contact
members or stable support may be continuously varied. As is
apparent from the description of the several embodiments, each of
the individual embodiments described and illustrated herein has
discrete components and features which may be readily separated
from or combined with the features of any of the other several
embodiments without departing from the scope or spirit of the
invention.
[0110] Referring to FIG. 1, a means for stabilizing the beating
heart is comprised of one or more, and preferably two, contact
members 1, which are attached to a rigid, or semi-rigid connecting
shaft 2 which is in turn connected to shaft means 3. The contact
members 1 may be substantially planar, may be slightly curved to
conform to the shape of the heart, or may be a non-conforming curve
to establish contact between only a portion of the contract member
1 and the beating heart. The contact members 1 may have any of
several alternate shapes including cylindrical members, members
formed into a U-shape, or may comprise a pair of substantially
parallel members spaced apart in a parallel configuration such that
a target artery can be positioned between the contact members. The
shape of the contact members may be varied depending on the
clinical assessment by the surgeon, the design of the other
features of the stabilizing means, or the design of other
instruments used to complete the anastomosis. In some embodiments,
as described herein, the contact members 1 may have apertures,
openings or attachments to facilitate connection with sutures or
other devices to achieve the requisite stabilization, occlusion of
the target vessel, or exposure of the target vessel. In a preferred
embodiment, a pair of substantially planar rectangular contact
members 1 are attached at one end to a continuous connecting shaft
2 and are oriented in a substantially parallel fashion such that a
target cardiac artery is positioned therebetween and passes along
the greater length of the contact members 1 when the stabilizing
means engages the heart. See FIGS. 72 through 74. The connecting
shaft 2 may be a continuous shaft for interconnection of the
contact members 1 without touching the artery or may include an
additional member which may be operated to contact the target
artery positioned between the contact members 1, see FIGS. 36
through 38, to occlude the passage of blood through the target
artery. The contact members 1, connecting shaft 2, and shaft means
3 may be composed of any non-toxic material such as a biocompatible
plastic or stainless steel, having sufficient tensile strength to
withstand a stabilizing force exerted on the heart via manipulation
or fixation of the shaft means 3 to cause the contact members 1 to
exert a stabilizing force on the beating heart. Also, while the
contact members 1 may each be connected to the connecting shaft 2
at one end, with the connecting shaft 2 operably attack to the
shaft means 3, each of the individual contact member embodiments
described and illustrated herein has discrete features which may be
readily separated from or combined with the features of any of the
other several embodiments, such as differing designs of the shaft
means, or other components of the invention by one of ordinary
skill in the art.
[0111] The shaft means 3 may be a simple rigid post or may be
comprised of a multi-component. system designed to be adjustable in
length and orientation at least one point along its length. Thus,
the length of the shaft means 3 and the orientation of the contact
members 1 at the distal (lower) end of the shaft means 3 can be
altered by the surgeon. Preferably, the length and orientation at
the shaft means 3 relative to the contact members 1 can be adjusted
by controls located at the proximal (upper) end of shaft means 3.
(As used herein, the term "distal" refers to a portion of a device
most proximal to the heart while the term proximal refers to the
opposite portion which may extend outside of the incision and which
is most often readily manipulated by the surgeon). This design
provides the advantage that the surgeon can introduce the
stabilizing means to the beating heart by placing the contact
members 1 on the surface of the heart, followed by the combination
of exerting a stabilizing force and locking the contact members 1
in place relative to the shaft means 3. Furthermore, the surgeon
may then lock the shaft means 3 into a fixed position by attachment
to a stable support such as the retractor, thereby maintaining the
stabilizing force for the duration of the procedure. In one
embodiment, the shaft means 3 has a housing 11 whose overall length
is adjustable by a telescoping release operated by an annular
thumbscrew 8 which tightens about the housing 11. The position and
orientation of the contact members 1 relative to the shaft means 3
is adjustable by virtue of a locking ball joint 5 which is
interposed between the connecting shaft 2 and which is located at
the distal end of shaft means 3. The locking ball joint 5 allows
the position of the shaft means 3 to be positioned with three
degrees of freedom relative to the contact members 1.
[0112] Referring again to FIG. 1, a locking ball joint 5 is
provided by including a block 6 within the shaft means 3 which
conformingly contacts the ball joint 5 and fixes the position of
the ball joint 5. Block 6 is compressed against ball joint 5 when a
threaded push block 7, connected to a long telescoping keyed shaft
and socket combination 9, and is actuated by means such as a
thumbscrew 8 at the upper end of the shaft means 3. In operation, a
rotation of the top thumbscrew 8 loosens the lower ball joint 5 to
allow continuous positioning of the shaft means 3 relative to the
contact members 1, and a counter-rotation locks the ball joint 5
into place, fixing the position of the contact members 1 relative
to shaft means 3.
[0113] The upper end of shaft means 3 may also have associated
therewith an upper ball joint 13 such that the shaft means 3 can be
oriented with four degrees of freedom relative to a fixed support
such as a retractor (not shown). The position and orientation of
the shaft means 3 may thus be fixed relative to the stable support
by a locking latch 14 or other conventional mechanism which
prevents movement of the upper ball joint 13. Either the shaft
means 3 or the retractor may contain the locking latch 14
surrounding the upper ball joint 13 or any like fixture to firmly
attach the shaft means 3 to a stable support, e.g., an anchor
portion 15 extending from the retractor (not shown).
[0114] Referring to FIGS. 1B through 1G, the contact members 1
preferably have friction means associated with their bottom surface
4 such that the contact members 1 more securely engage the beating
heart when a stabilizing force is exerted on the shaft means 3. The
friction means are preferably comprised of a textured surface
covering the bottom surface 4 of the contact member 1, and may be
comprised of several bio-compatible substances such as a textured
rubber, textured or ridged aluminum, stainless steel or the
like.
[0115] The friction means may also be affixed to or comprised of a
member disposed between the bottom surface 4 of the contact members
1 and the surface of the beating heart. In these embodiments, the
friction means is provided to facilitate stabilization of the
beating heart by maintaining close and conforming contact between
the contact member 1 and the beating heart and reducing the amount
of force necessary to be applied to the exterior of the beating
heart in order to achieve stabilization. Referring to FIGS. 1B and
1D through 1G, any number of different configurations and may have
a textured surface in a diamond plate, granular, nail-bed,
anti-skid, open foam, or other friction-providing configuration.
The geometric configuration of the surface, having one side affixed
to the contact member 1, may be flat, triangular, rectangular,
square, or circular. Alternatively, surfaces providing a functional
adhesive may be obtained using hydrogel, fibrogen, collagen,
hydroxy epitate, or other biocompatible material and may be
chemically etched, mechanically scored, or electrically
activated.
[0116] Referring to FIG. 2, one practical method for providing the
friction means is a separate member affixed to the bottom surface 4
of a contact member 1 comprising a snap-in member 16 having means
17 for removably attaching the snap-in member 16 to the bottom
surface 4 of the contact member 1. This removable attachment
feature may be readily provided by a post 18 affixed to each
snap-in member 16 and which fits engagingly in a port 19 formed in
the body of the contact member 1, or by other like configuration.
This embodiment offers several advantages in disposability and ease
of manufacture, particularly where it is desirable to provide an
adhesive or friction-providing member separately to the bottom
surface 4 of the contact member 1, and especially where the
friction or adhesive member is formed of a different material than
the body of the contact member 1. The bottom surface 4 of the
snap-in member 16 may have any of the configurations described
previously (See FIGS. 1B and 1D through 1G).
[0117] Given the delicacy of the epicardial cardiac tissue, and the
desire to avoid the possibility for damaging the heart as it beats
throughout the beating heart bypass procedure, and to avoid the
possibility that the stabilizing means might slip, the contact
members 1 of the invention may be provided with a
friction-providing and/or cushioning material at the lower or
bottom surface 4 of the contact member 1 to cushion the point where
the contact member(s) 1 engage the beating heart. For example, FIG.
3 shows an exemplary material 20 comprising a textured soft rubber
or fluid-filled member affixed to the bottom or lower surface 4 of
the contact members 1 to prevent damage to the heart tissue, and to
minimize slippage.
[0118] As noted above, a fundamental element of the invention is
the contact members which engage the surface of the beating heart,
in some embodiments proximal to the site of the anastomosis, to
directly apply the stabilizing force to the beating heart. The
actual shape, size, configuration, and relative orientation of the
contact members may vary without departing from the spirit of the
invention. For example, referring to FIGS. 4A and 4B, the contact
members 1 that engage the surface of the beating heart may be
provided by a solid structure 21, preferably a dense metal, which
provides an added weight to add to the stabilizing effect achieved
by contacting the beating heart with the stabilizing means of the
invention. This embodiment facilitates motion cancellation and
stabilization of the beating heart by adding additional weight
directly at the site where the contact member engages the beating
heart, which in this embodiment is at the site of the anastomosis.
As can be seen in FIG. 4B through line A-A of FIG. 4A, in this
embodiment, two contact members 1a, 1b engage the beating heart at
their lower or bottom surface 4, have a greater thickness at their
outer edges, and have an opening 22 positioned therebetween, and
which traverses the entire space between the contact members 1a, 1b
such that a vessel may be positioned therebetween.
[0119] FIG. 4C shows an integrated apparatus which may
advantageously apply the contact members 1 to the surface of the
beating heart by the action of a balance provided by an adjustable
weight 24 and counterweight 25 mourned on opposite ends of a shaft
26 mounted on a fulcrum 27 which is preferably affixed to a stable
support such as the operating table or an access platform providing
retraction during the surgery. By manipulating the adjustable
weight 24, varying degrees of stabilizing force may be applied to
the beating heart via shaft means 3 and the contact members 1. This
embodiment provides a continuously variable quantity of stabilizing
force directed downward by the positioning of the weights 24, 25
and the rotation of the shaft 26 about the point of the fulcrum 27.
Thus, in use, the surgeon may rest the contact members 1 on the
surface of the beating heart with a minimal force applied, and by
moving the adjustable weight 24 away from the fulcrum, cause
additional force to be applied, via the shaft means 3, and the
contact members 1, to the surface of the beating heart.
[0120] The positioning of the contact members 1 at the surface of
the beating heart to provide the requisite degree of stabilization
may be achieved by several techniques designed to apply a
mechanical force to the contact members that rest in a conformingly
fashion at the surface of the beating heart to substantially arrest
the movement in an atraumatic manner. The device shown in FIG. 5
has a pair of contact members 1a, 1b disposed in substantially
parallel fashion as in the embodiments previously described.
However, the device has an additional counter contact member 28
that also engages the surface of the beating heart, but does so at
a point slightly removed from the point of engagement of the other
contact members 1a, 1b which are preferably located at the site of
the anastomosis. Additionally, the shaft means 3 may be attached to
and be rotatable about a point 29 located between the contact
members 1a, 1b and the counter contact member 28 and preferably at
a point on the connecting shaft 2 that is slightly elevated. The
shaft means 3 is preferably rotatable, for example by virtue of a
ball joint 30, about the point 29 of contact thereby permitting the
contact members 1 to self-align and engagingly conform to the
surface of the beating heart. Moreover, in this embodiment, when a
stabilizing force is applied to the surface of the beating heart,
the force directed down the length of the shaft means 3 is not
centered over the site of the anastomosis. The counter contact
member 28 may also be configured to occlude the target vessel 31.
As with the other embodiments disclosed herein, an embodiment of
the type of FIG. 5 may be selected by the surgeon depending on the
particular clinical indication, the particular physiology of a
given patient, and/or the surgical environment dictated by the
access method used to gain access to the beating heart, for
example, sternotomy, thoracotomy, or puncture incision.
[0121] Thus, different surgical methods of access, different target
vessels, and the anatomical differences between individual
patients, may dictate the use of alternate embodiments of the
invention, typically at the discretion of the surgeon. For this
reason, contact members which are continuously adjustable, may be
particularly preferred for some clinical indications. For example,
FIGS. 6A and 6B show an embodiment of the invention having a
plurality of particles or beads 32 disposed within a substantially
flexible tubular structure or structures 33, and which may have a
vacuum lumen (not shown) located therein, to provide a contact
means 1 whose shape and position is adjustable. Preferably, the
flexible tube structure 33 has a malleable member 34 such as a wire
disposed along the length thereof to provide a structural memory
function and additional tensile strength. In the embodiment of FIG.
6A, the flexible tube 33 is a single unitary structure which can be
bent, typically in a U-shape configuration, to engage the surface
of the heart and may have plurality of discs 35 disposed along the
malleable member 34. Also, as illustrated by FIG. 6B, the
stabilizing means may be provided by a plurality of contact members
1a, 1b as otherwise described herein. As with the single unitary
structure of FIG. 6A, the plurality of the flexible contact members
1a, 1b may be provided with a plurality of beads or particles 32
disposed therein and may additionally have the ability to be
inflated selectively, or selectively deflated, to adjust or fix the
position of the contact members 1. When suction is applied via the
suction lumen, the particles 32 are compressed by atmospheric
pressure causing the tubular structure 33 to become rigid, thereby
fixing the information of the contact members 1.
[0122] As with the embodiments described above, adjustable
placement of the contact member may be particularly useful in a
minimally invasive procedure. Contact members that releasably
contact or are releasably attached to a shaft may be deployed by
separate insertion of the contact member, and a shaft or shafts
which may be independently introduced, manipulated, and withdrawn
to provide a stabilizing device held in place by pressure exerted
on the shafts while the anastomosis procedure is performed at which
time the contact members and shafts are removed in an atraumatic
manner. Referring to FIGS. 7A and 7B, a unitary contact member 1
has a plurality of recessed ports 36 adapted to receive the distal
end 37 of a shaft means 3, wherein the distal end 37 is shaped to
fit conformingly within the recessed port 36 and wherein the shaft
means 3 may be removably attached to the contact member 1. As seen
in FIG. 7B, this embodiment provides the advantage that the shaft
means 3 may be introduced through a plurality of very small
incisions such that several shaft means 3 may removably engage the
contact member 1 at the several points about the periphery of the
contact member 1 where the recessed ports 36 are formed in the
contact member 1 and receive the distal end 37 of a plurality of
shaft means 3.
[0123] FIG. 7C illustrates a separate removable shaft means 3a that
may be utilized with any of the embodiments of the contact members
1 previously described. In FIG. 7C, the separate shaft means 3a is
separately introduced and has a pair of distal ends 37 that engage
equivalently oriented and spaced ports 36 found in the contact
member 1 to provide an additional positioning and stabilizing
capability by manipulating the separate shaft means 3a when the
distal ends 37 engage the ports 36.
[0124] FIG. 7D is a simplified use of separate shaft means 3a
having an integral contact member 1 formed from the distal portion
38 of the separate shaft means 3a. In this embodiment, the separate
shaft means 3a are separately introduced into the surgical field
through minimally invasive puncture incisions and are separately
positioned to bring the distal portion 38 of each of the separate
shaft 3a to contact the surface of the heart. Referring to FIG. 7E,
the separate shafts 3a may be joined at the most distal tip by a
discrete interconnecting member 39 having openings 40 configured to
receive the most distal tip 37 of both of the separate shaft means
3a.
[0125] FIG. 8 is an additional embodiment of the contact members 1
of the invention generally comprised of an annular structure 41
which is rotatable relative to the shaft means 3 which is attached
at a point about the periphery of the contact member 1. In this
embodiment, a portion of the bottom surface 4 of the annular
portion 41 contacts the beating heart at a site proximate to the
target site for the anastomosis. The annular portion 41 of the
contact member 1 may be provided with a lockable fixture 42 which
engages the distal end of the shaft 43, where the shaft means 3
contacts the annular structure 41, to lock the shaft in place.
Alternatively, the shaft means 3 may rotate freely about the
periphery of the annular portion 41 of the contact member 1.
Preferably, a portion of the annular contact member 41 has a
passage 44 formed through the bottom surface 4 of the annular
contact member 41 where the target vessel 45 passes beneath the
annular contact member 41. Additionally, the annular contact member
41 may have substantially planar surfaces 46 which are generally
co-planar with the bottom surface 4 of the annular contact member
41 and have a rectangular opening therein for access to the target
vessel 45. Planar surfaces 46 may assist in providing stabilization
at the tissue proximate to anastomosis, and which also assist in
positioning the target vessel 45 relative to the annular contact
member 41.
[0126] The contact members of the invention may also be provided
with other related apparatus or fixtures that are commonly used in
traditional surgical procedures. Such structures or fixtures may be
operably associated with the body of the shaft means 3, the
interconnecting shaft 2, or the contact members 1.
[0127] Referring to FIGS. 9A through 9E, a suction (negative)
pressure or a blower (positive) pressure is useful to maintain a
clear and dry anastomosis site. The positive or negative pressure
may be provided to the contact member by a plurality of ports 47
formed in the body of the contact member. Each port is in pneumatic
communication with a lumen 48 that is in turn connected to a
suction or positive pressure source. Thus, by exerting either a
positive or negative pressure on lumen 48, the suction or positive
pressure is applied to the site of the anastomosis via ports 47. In
FIG. 9A, the ports 47 are disposed in the top surface of the
contact members 1 and have aligned openings in the direction of the
anastomosis site.
[0128] As shown in FIG. 9B, the plurality of ports 47 may be
provided in a discreet lumen 48 which is affixed to, and runs
longitudinally along, the length of the contact member 1. In this
configuration, the plurality of ports 47 are preferably disposed in
a linear configuration along one surface of lumen 48 to provide
negative suction pressure or a positive flow of pressure about the
surface of the contact member 1.
[0129] Referring to FIG. 9C, as mentioned above, the plurality of
ports 47 and the lumen 48 may be provided in a manifold-like
fashion wherein the openings of the plurality of ports 47 are
formed in the body of the contact member 1, as is the lumen 48
which is in communication with each port 47. As an alternate to the
plurality of ports 47, a single slot may be formed from the lumen
48, such that the slot runs along the greater length of the contact
member 1 as shown in FIG. 9D.
[0130] Referring to FIG. 9E, in a variation on the embodiment of
FIG. 9B, the lumen 48 may be provided as a malleable tube which is
separable from the contact member 1 along at least a malleable
portion 49 of said lumen 48. In this configuration, by manipulating
the malleable tube portion 49 of lumen 48, port(s) 47 may be
selectively positioned at any point proximate to the contact member
1.
[0131] Referring to FIG. 9F, a manifold similar to that shown in
FIG. 9C, may be provided within the body of the contact member 1 in
a configuration wherein the ports 47 are more closely associated
with the interconnecting shaft 2 or the shaft means 3. As in the
embodiment of FIG. 9C, the ports 47 are in communication with a
lumen 48 that runs the length of the shaft means 3 terminating in
the plurality of ports 47. As shown in FIG. 9F, the plurality of
ports 47 may apply the positive or negative pressure from the
portion of the interconnecting shaft 2 that joins the individual
contact members 1.
[0132] Referring now to FIG. 9G, as in FIG. 9E, a lumen 48 having a
malleable portion 49 may be provided for selective positioning of a
positive or negative pressure which may be applied at any point
proximate to the stabilizing means of the invention by manipulating
the position of the malleable portion 49 of the lumen 48 to
selectively position port 47.
[0133] In a similar structural configuration to FIGS. 9A through
9G, FIG. 9H supplies an incandescent or fiber optic light source
48a proximate to the contact members 1 by placing the light source
within the shaft means 3 to have an opening or lens to provide
light at the site of the stabilization.
[0134] An additional conventional surgical apparatus which may be
advantageously applied to the stabilizing means of the present
invention is a selectively positionable surgical drape that assists
in providing a dry and sterile field, and which assists the surgeon
during the procedure by visually isolating the site of the
anastomosis. FIG. 10A shows a retractable and extendable drape 50
surrounding shaft means 3. In the retracted configuration 51, shown
in phantom in FIG. 10A, the retractable drape is closely conformed
to the shaft means 3 to be unobtrusive. The drape 50 may be affixed
to the shaft means 3 by a washer element 52 that is directed
downward to deploy the drape 50. When the washer element 52 reaches
the maximum downward position, the retractable drape 50 is doubled
over to form a portion of a circular covering surrounding the
surgical site and generally opposite the area where the contact
members 1 abut the surface of the beating heart. An additional
embodiment, shown in FIG. 10B, has a surgical drape 50 affixed to
the outer portion of each contact member 1a, 1b. While this
configuration is not retractable, surgical drapes 50 as shown in
FIG. 10B may be provided with structural support members 53 that
provide tensile strength and shape to the surgical drape 50 and
which may provide supplemental stabilizing force by contacting the
beating heart about the periphery of the contact members 1a, 1b. An
additional configuration for surgical drapes 50 affixed to contact
members 1 is shown in FIG. 10C where a plurality of drape supports
protrude radially from several points about the periphery of the
contact members 1a, 1b an terminate in drape fastening means 54a at
their most distal portion. A portion of the drape 50 is attached to
each drape fastening means 54a to spread the drape over the
surgical site and may provide coverage extending in all directions
outward from the contact members 1.
[0135] Referring to FIG. 11, a mechanical fixture to facilitate
completing the anastomosis may be directly attached to the contact
member 1. A separate device to facilitate completing the
anastomosis is generally comprised of a hinged or rotatable vessel
support member 55 that permits selective positioning of the source
vessel, such as the distal end of an internal mammary archery or
the distal end of a venous or arterial graft, proximate to the
target vessel 56. The vessel support member 55 is oriented on the
contact member 1 such that the vessel source brought into direct
alignment with an arteriotomy formed in the target vessel 56, which
is disposed between the contact members 1. To facilitate the
completion of the anastomosis, a vessel receiving member 57 is
closely associated with the contact members 1 and generally
surrounds the arteriotomy in the target vessel 56. The vessel
support member 55 has an anastomosis coupling fixture 58 that is
attached to the distal end of the source vessel and is shaped to be
brought into engagement with the vessel receiving member 57. The
anastomosis coupling fixture 58 is attached to the periphery of the
IMA or graft such that when the vessel support member 55 is
positioned proximate to the arteriotomy, the vessel receiving
member 57 and the anastomosis coupling fixture 58 are brought into
alignment such that a fluid communication between the source vessel
59 and the target vessel 56 is established upon completion of the
anastomosis. Completion of the anastomoses is facilitated by an
automatic suturing securing mechanism 60 or other like apparatus
for tightening the sutures to join the two vessels. Preferably, the
vessel receiving member 57 and the anastomosis coupling fixture 58
are operably associated with a plurality of sutures 61 which
penetrate the periphery of the arteriotomy formed in target vessel
56 and connect the periphery of target vessel 56 to the periphery
of the source vessel 59. Thus, while simultaneously actuating the
vessel support member 55, the automatic suturing device 60 brings
the vessels into close conformity and completes the anastomosis
procedure to establish fluid communication between the source
vessel 59 and the target vessel 56.
[0136] Referring to FIG. 12, a separate member for conveniently
holding the source vessel may be provided without a dedicated
apparatus for completing the anastomosis. A malleable wire 62 is
operably affixed to the shaft means 3 or to the contact member (not
shown) and has a source vessel holder 63 such that the source
vessel 64 may be prepared and conveniently held at a point away
from the target vessel 56 until the surgeon is prepared to complete
the anastomosis. Preferably, the source vessel holder means 63 is
comprised of a clamp for gripping and maintaining the source vessel
64 in a preferred configuration prior to completing the
anastomosis, such as by separating or spreading the tissue attached
to the most distal portion of the source vessel 64 to maintain the
integrity and patency of the distal end of the source vessel
64.
[0137] As mentioned above, it is particularly preferred that the
instruments of the invention be used in a minimally invasive bypass
graft procedure wherein a minimal thoracotomy provides access to
the beating heart. A minimal thoracotomy is a small surgical
opening provided between the ribs and is formed, to the extent
possible, proximate to the target artery of the beating heart where
the anastomosis is to be formed. To provide access to the beating
heart via the minimal thoracotomy, the cannula may be disposed
between the ribs to provide access to the beating heart. Referring
to FIGS. 13A through 13E, alternate configurations for a cannula
disposed between adjacent ribs are shown. The embodiment of FIG.
13A has a cannula support bracket 67 having a plurality of holes
through which screws 66 may pass to provide means to attach the
assembly to the chest such as by placing the screws in adjacent
ribs 69a, 69b. The cannula receiving assembly 67 may have one slot
65 formed therein such that one of the screws 66 may slide therein
for spreading the adjacent ribs 69a, 69b apart. The cannula
receiving assembly 67 provides an opening between adjacent ribs 69a
and 69b such that the cannula 68 may be passed therethrough.
Referring to FIG. 13B, in an alternate embodiment, the cannula
receiving assembly 67 is replaced by a cannula 68 surrounded by a
large thread means 70. The distal end 71 of the cannula 68 may be
inserted between the ribs and rotated such that the thread means 70
cause cannula 68 to be advanced between the adjoining ribs 69a,
69b, and by virtue of the expanding diameter of the thread means
70, to spread adjoining ribs 69a, 69b apart while positioning the
cannula 68 therebetween. In yet a further embodiment, in FIG. 13C,
a cannula assembly 75 is provided having a claw mechanism comprised
of opposing blades 73 and interlocking member 72. Adjacent ribs
69a, 69b are engaged by opposing blades 73, and, by forcing the
cannula 68 downward, the opposing blades 73 rotate outwards until a
locking member 72 fixes the position of the opposing blades 73 in a
locked and opposing relationship as shown in FIGS. 13D and 13E.
Thus, by forcing cannula 68 downward, adjacent ribs 69a and 69b are
spread apart by opposing blades 73 and the cannula assembly 75 is
fixed in position by locking member 72 such that cannula 68 is
positioned to provide access to the beating heart.
[0138] A modified large diameter cannula having an extended
vertical height, may perform several functions in a minimally
invasive CABG procedure. For example, referring to FIG. 14, an
enlarged cannula 74 may be provided in the shape of an inverted
cone structure having an enlarged proximal opening 76 with an
enlarged diameter, and a distal opening 75 having a reduced
diameter and where said distal opening 75 abuts the surface of said
beating heart. By exerting a downward force on the inverted,
enlarged cannula 74, the inverted conical shape of the cannula 74
forcibly spreads adjacent ribs 69a, 69b, and provides a stabilizing
force when the distal portion 75 contacts the surface of the
beating heart. Surgical access to the stabilized heart is provided
through enlarged proximal opening 76.
[0139] FIGS. 15A and 15B show an embodiment of the invention in use
with a conventional cannula. In FIG. 15A, a conventional cannula 77
is inserted through a puncture incision in chest wall 80. The
distal end of the stabilizing means 78 (similar to FIGS. 31A and
31B below), is introduced in a contracted configuration through the
cannula 77 to bring the distal end thereof in contact with the
surface of the beating heart 79. Referring to FIG. 15B, the
stabilizing means of the invention are fully inserted through the
cannula 77 and manipulated to bring the contact members 1 into
contact with the surface of the beating heart 79. By manipulating
handles 81 of the stabilizing means, the contact members 1 are
spread apart at the surface of the beating heart to provide the
stabilizing function during the surgical procedure.
[0140] Where a minimally invasive procedure is employed, the means
for stabilizing the beating heart of the invention are preferably
provided in an embodiment where the contact members 1 that engage
the surface of the beating heart are inserted and withdrawn from
the surgical field in a position or a configuration having a
reduced dimensional profile, i.e., a reduced effective diameter
when inserted and removed from the thoracic cavity. For example,
these embodiments are particularly useful when the surgery is
performed through a plurality of puncture incisions.
[0141] In the embodiment of FIGS. 16A through 16E, a pair of
rectangular, and substantially planar contact members 1a, 1b are
disposed within a generally cylindrical main shaft 82. In the
retracted configuration shown in FIG. 16A, each contact member 1a,
1b is rolled into a collapsed, annular configuration to reduce the
effective diameter of the device by having the contact members 1a,
1b maintained within the shaft 82 when the device is inserted
through an incision. In this configuration, each contact member 1a,
1b is attached to a central shaft 83 by a connecting shaft 2 which
has a tensioning wire 84 or spring mounted to the connecting shaft
2 and the central shaft 83 to deploy each contact member 1a, 1b
when the central shaft 83 is extended from the substantially
cylindrical main shaft 82 in which the contact members 1a, 1b are
originally retained. Thus, in use, the contact members 1a, 1b are
maintained in the retracted annular configuration of FIG. 16A until
deployed within the surgical field as shown in FIGS. 16B through
16E, by extending the central shaft 83 downward causing the contact
members 1a, 1b to be deployed below the main shaft 82. The contact
members 1a, 1b unfold from their annular configuration and deploy
into their substantially planar shape as shown in FIG. 16C. The
contact members 1a, 1b rotate into position relative to the central
shaft 83 by the tension in wire or spring 84 which is preferably
disposed to act upon the connecting shaft 2 to cause contact
members 1a, 1b to be fixed in a substantially parallel position to
one another and substantially co-planar with the surface of the
beating heart as shown in FIGS. 16D and 16E.
[0142] Thus, FIG. 16A shows the contact members 1a, 1b in their
collapsed or retracted position. FIG. 16B shows the contact members
in the process of being deployed as the central shaft 83 is
extended from the bottom of the main shaft .82. FIGS. 16D and 16E
show the tensioning wire 84 for repositioning the contact members
1a, 1b in the desired position for use in surgery. FIG. 16C shows
the central shaft 83 filly extended from the bottom of the body of
the main shaft 82 causing the deployment of the contact members 1a,
1b into the desired configuration for stabilizing the beating
heart.
[0143] Preferably, the connecting shaft 2 joining the individual
contact members 1a, 1b is hinged 85, such that upon completion of
the anastomosis, the contact members 1a, 1b may be withdrawn by
pulling the central shaft 83 upward relative to the main shaft 82
and into the body of the device, thereby causing the contact
members 1a, 1b to be removable in a low-profile configuration.
[0144] Referring to FIGS. 17A through 17D, a similar strategy as is
shown in FIGS. 16A through 16E is used whereby a pair of contact
members 1a, 1b are deployed by a main shaft 86 within a hollow
portion of the body 87 of the device. In the embodiment shown in
FIGS. 17A through 17D, a pair of non-flexible contact members 1a,
1b may be provided to stabilize the beating heart in a minimally
invasive environment by containing the contact members 1a, 1b in a
body or housing 87 which is inserted through the minimally invasive
incision. In this embodiment, the contact members 1a, 1b are
mounted to a central shaft 86 by virtue of a pin or hinge 88 which
affixes the end of the contact members 1a, 1b to the central shaft
86 such that the contact members 1a, 1b may be deployed by rotating
around the pin or hinge 88 when the shaft 86 is extended downward
from the body 87 of the device. The opposite portion of the contact
members 1a, 1b (most distal from the hinge) may fit within a guide
fixture 89 concentrically associated with the central shaft 86 that
retains the contact members 1a, 1b in the desired configuration
prior to deployment. In use, the central shaft 86 telescopes from
an opening in the distal end of the body or housing 87 of the
device by a distance at least as great as the overall length of the
contact members 1a, 1b, at which point the contact members 1a, 1b
may be deployed and locked into position, for example, in an
orientation substantially perpendicular to the shaft as shown in
FIGS. 17A and 17C. Once fixed in position by locking mechanism 90
as shown in FIG. 17C, the central shaft 86 may be rotated using the
guide fixture 89 which is positioned downward to engage the contact
members 1a, 1b. Thus, the guide fixture 89 engages the contact
members 1a, 1b, the pin 88, or the locking mechanism 90, and by
applying mechanical force, the position of the contact members 1a,
1b may be adjusted. Upon removal, the central shaft 86 is withdrawn
into the body 87 of the device. Alternatively, the housing 87 may
disengage the locking mechanism 90 from the guide fixture 89
releasing the position of the contact members 1a, 1b thereby
allowing the contact members 1a, 1b to be returned to their
original or other configuration that allows the contact members 1a,
1b to be drawn into the body of the device 87 to facilitate
minimally invasive removal thereof.
[0145] FIGS. 18A through 18D are an analagous embodiment having
contact members 1a, 1b retained in the undeployed configuration
suitable for insertion through a minimally invasive incision. As
shown in FIGS. 18A and 18B, the contact members 1a, 1b may be
maintained in a retracted position such that the length of the
contact members 1a, 1b is substantially parallel to the central
shaft 92. The proximal end of each contact member 1a, 1b is affixed
to the guide fixture 93 while the distal end (below the hinge at
central portion 91) has the bottom surface 4 formed therein and is
affixed to the distal end of the central shaft 92. Referring to
FIG. 18C, the contact members 1a, 1b are deployed by the downward
motion of the guide fixture 93, such that the contact members 1a,
1b fold about the central portion 91. When the guide fixture 93 is
fully extended downward, the contact members 1a, 1b are formed of a
pair of two-part structures wherein the lower structure contains
the bottom surface 4.
[0146] FIGS. 19A and 19B are an additional embodiment having
foldable contact members 1a, 1b wherein a central shaft 94 is
affixed to a plurality of hinged struts 95 that are connected to
opposite ends of contact members 1a, 1b about a hinged central
portion 96. When the central shaft 94 is extended downward, the
hinged struts 95 deploy outward. As shown in FIG. 19A, the
individual contact members 1a, 1b fold at the central hinged
portion 96 to reduce the overall dimensional profile of the device
for minimally invasive insertion or removal. When fully deployed
(FIG. 19B), the contact members 1a, 1b are extendable to a
substantially planar configuration as with other embodiments
disclosed herein.
[0147] FIGS. 20A through 20E show the central shaft 97 and contact
members 1a, 1b with alternate configurations for positioning the
contact members for minimally invasive insertion and removal.
Referring to FIG. 20A, first hinges 98 are provided in the
connecting shaft 2 such that the contact members 1a, 1b can be
rotated approximately 90.degree. out of their co-planar
configuration. A second hinge 99 is provided between the shaft
means 3 and the connecting shaft 2 to tilt the distal end of the
contact members 1a, 1b downwards as shown in FIG. 20C. The
embodiments of FIGS. 20D and 20E are modified such that two
interconnecting shafts 2a, 2b maintain the contact members 1a, 1b
in slightly separate, yet parallel, vertical positions. A single
hinge 100 with a vertical axis of rotation allows the contact
members to be brought into close conformity before being tilted
downward.
[0148] FIGS. 21A through 21C show a deployable stabilizer of the
invention having contact members comprised of a single continuous
wire 101 that is deployable from within a housing or body 102 which
is ideally inserted through a minimally invasive incision. As shown
in FIG. 21A, the single continuous wire 101 may be coiled and
contained within the housing 102 such that the dimensional profile
of the stabilizer is minimized for insertion. The wire 101 which
forms the contact member(s) of this embodiment is preferably round
and smooth, and may be formed of a material such as Nitinol that is
collapsible, and deployable into a pre-determined shape. As can be
seen in FIG. 21B, following insertion, the wire 101 is extended
from the body 102 of the device to form at least one loop 103
wherein at least one side 104 of the loop 103 contacts the surface
of the heart. Preferably, at least two loops 103 extend from the
body 102 of the device and are formed from a single wire 101. In
this configuration, maximum stabilization is achieved if
substantial portions of the sides 104 of both loops 103 contact the
beating heart proximate to the target vessel. As in the previous
embodiments, the insertion and removal of the stabilizing device
through a very small incision is least traumatic when the
dimensional profile, or effective diameter, of the contact members
in a retracted configuration is not substantially greater than the
dimensional profile or diameter of the body 102 of the device.
Thus, as can be seen in FIG. 21C, the contact members of the
embodiment of FIGS. 21A through 21C are drawn upward by exerting
force on the wire 101, the contact members comprised of loops 103
are drawn into a configuration which is in alignment with the body
102 of the device such that their removal may be achieved through a
puncture incision with minimal additional trauma to the
patient.
[0149] In addition to a single continuous wire 101, the contact
members may be formed of a helical wire coil 105 as shown in FIGS.
22A through 22C. As in the embodiments described previously, the
contact members 1a, 1b are deployed by extending a tubular central
shaft 106 through a body or housing 107 of the device to deploy the
contact members 1a, 1b. The downward motion of the central shaft
106 is terminated by the contact between a stop 109 and the distal
end of the body 107. The contact members 1a, 1b are withdrawn into
the body 107 of the device upon completion of the surgical
procedure by pulling the central shaft 106 vertically through the
body 107 of the device. A predetermined curve in the helical coil
105 may be provided by spacing members 108 placed between adjacent
individual loops 105a and 105b of the helical coil 105. The central
locking wires or cables may be tensioned upon deployment to
increase the rigidity of the structure.
[0150] An additional configuration for minimally invasive insertion
and removal is shown in FIGS. 23A and 23B wherein the contact
members 1a, 1b are formed of an inflatable balloon 110 that is
pre-shaped to provide any desired configuration of the contact
members 1a, 1b FIG. 23A shows a pre-formed inflatable balloon 110
in an inflated state and extended from the housing 111. Inflation
is achieved by a central lumen 112 disposed within the central
shaft 111. FIG. 23B shows the inflatable balloon 111 in an
uninflated state for insertion or for removal.
[0151] Referring to FIGS. 24A and 24B, an inflatable contact member
may also be provided by a cuff 113 which is positioned such that
the circumference of the cuff 113 contacts the beating heart about
its periphery. Preferably, the target vessel 114 is positioned to
bisect an annular cuff 113 to provide maximum stabilization.
Additionally, referring to FIG. 24B, separate contact members 1a,
1b, as previously described herein, may be integrally formed with
the cuff 113 by mounting the contact members 1a, 1b in the wall of
the cuff 113 to extend into the interior thereof.
[0152] FIGS. 25A and 25B illustrate an embodiment of the invention
which provides minimal trauma to the patient during insertion and
removal of the 'stabilizing means by containing a simple stabilizer
in an instrument having a housing 115 with an extremely limited
cross-section such that the instrument can be inserted through an
extremely small incision. In this embodiment, the entire
stabilizing means is contained within the hollow housing 115 and is
comprised of a pair of contact members 1a, 1b which are joined at
the most distal end thereof. As can be seen in FIG. 25B, the
contact members 1a, 1b are formed from a unitary shaft 116 having a
divided portion 117 at the distal end such that upon deployment
from the housing 115 of the device, the divided portion 117 splits
into two contact members 1a, 1b joined at their most distal tip 118
and which may be brought into contact with the beating heart along
the divided portion 117 of the unitary shaft 116.
[0153] In addition to the friction means or cushioning members
described above in FIGS. 1B through 1G and FIG. 3, sutures may be
used to attach or position epicardial tissue relative to a contact
member 1 to enhance the stabilization function of the invention and
to position epicardial tissue or the target vessel of the
anastomosis. FIGS. 26A, 26B, and 26C are embodiments where means
for fixing the position of epicardial tissue is comprised of
sutures 119 used in combination with the contact members 1a, 1b to
stabilize and position tissue surrounding the site of an
anastomosis and the target cardiac artery. In FIG. 26A, a series of
sutures 119 is placed through the epicardial tissue (not shown) and
looped around the contact members 1a, 1b to effectively position
several points on the surface of the beating heart in fixed
relationship to the contact members 1a, 1b. In FIG. 26B, the
contact members 1a, 1b and optionally the shaft means 3 associated
therewith have passages 120 formed therein through which a suture
line 119 may be passed. In the particular example of FIG. 26B, a
single suture 119 is passed through the body of the shaft 3, exits
from within the first contact member 1a through a passage 120
formed therein, passes underneath the target vessel 121, emerges
from an opposite side of the target vessel 121, and enters a
passage 120 in the opposite contact member 1b joined to the first
contact member 1a by the connecting shaft 2. The suture 119 exits
the opposite contact member 1b again passes beneath the target
vessel 121, reenters the first contact member 1a at a separate
passage 120, and passes through the body of the first contact
member 1a and into the shaft means 3. In this configuration, the
suture lines may be manipulated by the surgeon from a remote
location, such as external to the incision in the chest, to
remotely position the vessel by drawing tension on the suture line
119. FIG. 26C shows a similar arrangement for the suture line 119
as in FIG. 26B, however in FIG. 26C, apertures 122 in the body of
the contact member 1 are used to select the direction of the suture
119 rather than having passages 120 which traverse the body of the
contact member 1. Also, in this or the other embodiments, a
separate sliding shaft 123 may be provided that gathers and is
traversed by the sutures 119. The step of drawing tension on the
suture line 119 is facilitated by advancing the sliding shaft 123
to abut the contact member 1 and exerting a small downward force on
the sliding shaft 123 while exerting an upward force to draw
tension on the suture line(s) 119. By maintaining downward force on
the sliding shaft 123, the target vessel 121 is raised while the
potential for displacing the contact member 1 is minimized because
the upward force exerted on the suture lines 119 is countered by
the downward force exerted on the sliding shaft 123.
[0154] Referring to FIGS. 27A and 27B, a modification of the
contact member 1 of the invention may be provided by a structure
formed at the distal end of the shaft means 3 and which is inserted
directly into the arteriotomy 124 formed in the target vessel. This
intravessel stabilizer 126 has a body designed to fit conformingly
about the interior of the target vessel, and may be in
communication (including fluid communication) with a hollow portion
of the shaft means 3. The body 126 of the intravessel stabilizing
means may be a substantially cylindrical lumen as shown in FIG. 27B
and should have an overall length which is greater than the length
of the incision creating the arteriotomy 125. Additionally, in the
embodiment of FIG. 27B, the intravessel stabilizer 126 may be
perpendicular to the shaft means 3 and have cuffs 127 at the distal
end of the body 126 to provide conforming engagement with the
interior of the target vessel. As shown in both FIGS. 27A and 27B,
this embodiment of the stabilizing means of the invention is
preferably used in connection with a plurality of sutures 128 that
penetrate edges of the target vessel about the circumference of the
arteriotomy 125. By exerting pressure on the shaft means 3 and the
plurality of sutures 128, the target vessel is stabilized, and its
position may be manipulated, to facilitate completion of the
anastomosis.
[0155] In addition to stabilization of the beating heart proximate
to the target vessel of the anastomosis, additional fixtures,
structures or elements associated with the contact members 1 can be
used to retract or fix epicardial tissue proximate to the target
vessel and the site of the anastomosis by using a means for
gripping epicardial tissue at the surface of the exterior of the
heart. The means for gripping may be provided by several different
embodiments. For example, FIG. 28A shows a functional clamp 128
formed by a crimping contact member 1 that has a fold 129 disposed
longitudinally at the center of the length of the contact member 1.
When force is applied to the sides of the contact member 1 opposite
the fold 129, the crimping action of the contact member 1 grasps
the epicardial tissue 130 at the heart surface 131 and contains it
within the folded contact member 132. In another embodiment, as
shown in FIG. 28B, a plurality of open passages 133 are provided in
a contact member 1 that has a slidable member 134 disposed within a
slot 135 formed within the contact member 1. When sufficient force
is exerted in a downward direction on shaft 3 to force epicardial
tissue 130 through the open passages 133, the slidable member 134
then may be actuated to grip the tissue 130 contained within the
open passages 133. By gripping a portion of epicardial tissue 130,
the tissue may be spread to more readily expose the target vessel
136 of the anastomosis.
[0156] A similar function is provided by a pair of contact members
1 that are formed of circular rollers 137 that lie longitudinally
parallel to the direction of the target vessel 136 as shown in
FIGS. 29A and 29B. The contact members 1 may be comprised of
movable rollers 137, belts, or pivoting surfaces that may be
rotated independently about an axis 138 dedicated to each contact
member 1 such that the epicardial tissue 130 is gathered or spread,
depending on the respective directions of rotation of the rollers
137, as desired at the surface of the heart to expose the target
vessel 136. As will be apparent to those skilled in the art, each
of these embodiments may be provided with contact members 1 that
are independently movable in a parallel, V-shaped, or other
adjustable configuration as described and illustrated herein.
[0157] Referring to FIG. 30, the contact members 1 may be further
comprised of a spring-tensioned frame 139 having a movable frame
extension 140 which may have pins or an associated friction means 4
at the bottom surface 4 of the contact members 1a, 1b to engage the
tissue proximate to the target artery. The movement of the frame
extension 140 is tensioned by a spring means 141 which draws the
frame extension 140 toward the contact member 1 after the frame
extension 140 has been manually positioned to engage the tissue.
The use of this embodiment of the invention is the sa me as is
described for the other embodiments herein, with the frame
extension 140 providing the improved exposure of the target artery
by retraction of the epicardial tissue. As with the other
embodiments, the contact members 1 may be attached at one end by a
connecting shaft 2 which is attached to a shaft means 3 as
described above. The connecting shafts 2 may also be positioned
relative to one another by a conventional threaded post 142 with a
positioning thumbscrew 143.
[0158] Referring to FIGS. 31A and 31B, the stabilizer means may
also be comprised of a single shaft means 3 connected to each
contact member 1. In a preferred embodiments the shaft means 3 are
interconnected at an intermediate pivot point 144 which permits the
contact members 1 to be continuously positioned in parallel fashion
relative to one another. The proximal (upper) portion of the
individual shaft means 3 may have grips adapted to be grasped by
the hand or may have an anchor portion 145 for attachment to a
retractor or other fixed support. As with the other embodiments
described herein, the length of the shaft means 3 may be adjustable
by a conventional telescope configuration. In such a configuration,
a first shaft 148 has a partially hollow segment 147 adapted to
receive the complimentary portion of the second shaft 148. Either
first 146 or second 148 shafts may be connected to the contact
members 1 and may each have a conventional interlocking mechanism
151 to fix the relative positions of the shafts. The shaft means 3
may also have a tensioning spring mechanism 150 having an axis 149
which is displaced between a portion of the shaft means 3 affixed
to the contact members 1 and the remainder of the shaft means 3. In
this configuration, the contact members 1 remain tensioned against
the heart proximate to the anastomosis site when the proximal end
of the shaft means 3 is affixed to a stable support. This
embodiment also preferably has a friction means as described above
affixed to the bottom surface 4 of each contact member 1. An
addition advantage of this embodiment is derived from the
capability to move the contact members 1 apart from one another in
a parallel configuration. Thus, the contact members 1 can first be
positioned to engage the surface of the heart tissue, followed by
the application of a stabilizing force in combination with
spreading or joining of the proximal (upper) end of the shaft means
3. Application of a stabilizing force causes the tissue on either
side of the target artery to be spread or compressed while the
heart is stabilized. Thus, by coincidentally spreading or joining
the proximal portion of the. shaft means 3, the epicardial tissue
engaged by the contact members 1 is stretched or compressed to
provide stabilization and improved exposure and positioning of the
target coronary artery.
[0159] Referring to FIGS. 32A through 32C, the contact members 1
may have associated therewith additional structures which serve to
position or retract epicardial tissue, at or around the surface of
the heart, particularly tissue in the vicinity of the site of the
anastomosis. Often, the surgeon wishes to retract the epicardial
tissue near the target vessel to increase exposure of the vessel
where the anastomosis is to be performed. Additionally, these
associated structures provide an additional amount of stabilization
by actually penetrating the tissue at the outer layer of the heart
and holding the tissue in close conformity to the contact
member.
[0160] Referring to FIG. 32A, epicardial tissue retractors are
provided by a series of curved pins 152 which generally extend from
one contact member 1a to the other 1b by virtue of a guide 153
attached to the bottom of each contact member 1 and which is
dedicated to a single pin 152. In this embodiment, a plurality of
pins 152 are substantially parallel to one another and may be
inserted and positioned to pass beneath the vessel where the
anastomosis is to be performed. In this fashion, the surgeon can
position the vessel, by virtue of the tissue engaged by the pins
152 and the contact members 1a, 1b in any direction. This
embodiment is particularly useful to vertically displace the
tissue, i.e., in a direction perpendicular to the shaft means
3.
[0161] An additional embodiment is shown in FIG. 32B, whereby a
plurality of short pins 154 extend down from the bottom surface 4
of the contact member 1 to enter the epicardial tissue. The short
pins 154 may extend in a direction substantially perpendicular to
the surface of the tissue and the bottom surface 4 of the contact
member 1, or may be angled outward to engage the tissue. The
advantages of this embodiment are best utilized with a stabilizing
means wherein the individual contact members 1a, 1b may be
selectively positioned such that the distance between the
individual contact members is varied. Thus, the contact members 1a,
1b can be brought into contact with the surface of the beating
heart followed by spreading the contact members 1a, 1b apart from
one another to provide retraction and spreading of the epicardial
tissue. This is readily achieved in the embodiment of FIG. 32B,
wherein a single shaft means is dedicated to each contact member
1a, 1b, respectively and the individual shafts are joined by an
intermediate pivot point 155.
[0162] A similar embodiment is shown in FIG. 32C, however, in this
embodiment, while each contact member 1a, 1b has a dedicated shaft,
the shaft 156 dedicated to the first contact member 1a is disposed
within a hollow shaft 157 dedicated to the second contact member
1b. In this configuration, each shaft 156, 157 may be individually
rotated about the other to provide a V-shaped retraction of the
epicardial tissue. In this embodiment, the epicardial retractor
pins 154 are preferably similar in structure and orientation to the
embodiment of FIG. 32B. The pins in both designs could
alternatively be curved or angled inward, and the contrast members
1 moved toward each other, providing a compression of the
epicardium to stabilize the tissue and present the anastomosis site
to best advantage. This action may also serve to occlude the blood
flow in the coronary artery, minimizing blood loss and obstructions
of the visual field.
[0163] Referring to FIGS. 33A and 33B, the stabilizer means may
comprise at least one stabilizer plate which is attached to a
stable support by the shaft means 3 and which may be used with a
lever member 158 for improving exposure at the target artery while
the anastomosis is completed. In this embodiment, the means for
stabilizing the beating heart comprises a left and right
stabilizing plate 159, 160 which are oriented to exert a downward
force on the epicardial tissue at either side of the target artery
at the anastomosis site and which may be substantially planar or
may be curved to conform to the surface of the heart. One or both
of the stabilizing plates 159, 160 may have an edge 161 deflected
downward along its length so that the edge 161 depresses the tissue
proximate to the artery to increase the exposure of the artery
during the completion of the anastomosis. Preferably, the edge 161
of the stabilizing plates 159, 160 has a separate lever member 158
running substantially parallel to the artery and on both sides
thereof. The top portion of each lever member 158 contacts the
underside of the stabilizing plates 159, 160. In this embodiment,
the lever member 158 is substantially cylindrical, traverses the
stabilizing plate along its length, and is oriented to be parallel
to the edge 161 of the stabilizing plate 159, 160. The lever member
158 is fixed in place, and may be affixed to the heart by a suture.
In such a configuration, each of the stabilizing plates 159, 160,
which is in contact with the lever member 158 along its length,
contacts the heart such that the edge 161 depresses the tissue on
both sides of the target coronary to restrict the movement of the
beating heart. The stabilizing plates 159, 160 can be attached to
one another or can move independendy as desired.
[0164] Opposite the edge 162, at a point separate from the lever
member 158, the stabilizing plates 159, 160 are connected to a
shaft means 3 which holds the stabilizing plates 159, 160 in
position and which may be manipulated relative to the lever member
158 to cause the edge 161 to engage the heart. The shaft means 3 is
preferably affixed to each stabilizing plate 159, 160 at a point
opposite the edge 161 and removed from the point where the lever
member 158 contacts the stabilizer plates 159, 160 at a location to
maximize leverage when the stabilizer plates 159, 160 are drawn
upwards at the point of attachment of the shaft means 3. The shaft
means 3 may be constructed as described elsewhere herein and should
be of sufficient length to facilitate manipulation of the shaft
means 3 by the surgeon. As noted, the shaft means may also be
attached to the retractor to fix movement of the stabilizing plates
159, 160 during the procedure.
[0165] In a preferred embodiment, the length of the shaft means 3
is adjustable relative to the retractor or other stable support.
For example, the shaft means 3 may be telescopic as described above
or may be comprised of a hollow post 163 which receives a rigid
shaft 164 which is in turn fixed to the retractor. The rigid shaft
164 may also be substantially hollow and may have a suture or other
line 165 passed therethrough and which also passes through the
length of the hollow post 163. In this configuration, one end of
the suture or line 165 is attached to the stabilizing plates 159,
160 and the other end extends through the hollow post 163 or the
rigid shaft 164 to a position where it may be manipulated by the
surgeon. The position of the. stabilizing plate 159, 160 may
thereby be remotely actuated. By drawing tension on the suture or
line 165, the stabilizing plate 159, 160 pivots about the lever
member 158 and the edge 62 of the stabilizer plates 159, 160
depress the tissue on either side of the target artery.
[0166] Referring to FIGS. 34A through 34E, a lockable mechanism may
be provided to depress tissue on either side of a target vessel by
a movable edge 176 formed along the edge of a block 177 which
rotates about a support member 178 by means of a hinge pin 179. The
support member 178 may be affixed to the upper surface of a contact
member as described herein or may itself comprise the contact
member. In use, as shown in FIG. 34B, the block 177 is rotated
about the support member 178 using hinge pin 179 until the movable
edge 176 contacts the surface of the heart parallel to the target
vessel 180 (FIG. 34C). The moveable edge 176 and block 177 are
fixed in place by depressing locking member 181 to force the block
177 to rotate until an interconnecting member 182 extends the block
177 and edge 17 to fully depress the tissue proximate to the target
vessel 180. At this point, and shown in FIG. 34D, the locking
member 181 fixes the interconnecting member 182 in an extended
position and is locked in place (FIG. 34E). The position of the
block 177 may be released by actuating the locking member 181 to
release the interconnecting member 182.
[0167] Due to the fact that the heart continues to beat during the
CABG procedures described herein, features of the invention which
provide the capability to manipulate the target vessel, and to
control the flow of blood therein, may greatly facilitate an
efficient completion of the anastomosis. For example, additional
components associated with the contact members 1 may be used to
occlude the target vessel during the anastomosis procedure. Any of
a variety of fixtures may be provided to operate in association
with the contact members of the invention in order to occlude the
vessel that is the target of the anastomosis.
[0168] Referring to FIG. 35, a stabilizing means 166 is comprised
of a contact member which is substantially planar and has a
substantially rigid surface 167 having a centrally disposed opening
168 in which the target artery of the anastomosis is positioned
longitudinally through the opening. At either or both ends of the
centrally disposed opening 168, an occluder 169 extends below the
surface 167 and engages the target artery to substantially reduce
or eliminates the flow of blood through the artery. The occluder
169 is a deformable member having a smooth outer surface for
adjustably contacting and depressing the target artery without
damaging the tissue. The planar surface 167 of the stabilizing
means also has an aperture 170 comprising an opening which
traverses the entire planar surface 167 so that the graft can be
passed through the aperture 170 when the anastomosis is completed.
The planar surface 167 may also provide a mounting surface for
springed tissue retractors 171 comprising a coiled spring 172
attached to the planar surface at one end and having a hook or pin
173 at the opposite end to engage and spread the tissue proximate
to the anastomosis site to improve the exposure of the target
artery. The planar surface 167 is attached to a post 174 which may
be attached to a stable support such as a rib retractor. The planar
surface 167 may also have at least one port 175 for receiving a
suture line.
[0169] Referring to FIG. 36, the stabilizing means may have
operably associated therewith an artery occluder 183, which is
preferably attached to the contact members 1 or to the connecting
shaft 2. The artery occluder 183 may comprise a semi-rigid member
which has a blunt portion 184, which may be positioned such that
the blunt portion 184 engages the target artery 185 and compresses
the target artery 185 to a point causing occlusion of the target
artery 185 passing between the contact members 1 such that the
blood flow through the artery is substantially reduced or
eliminated. Preferably, the occluder 183 has a shaft portion 186
which traverses the connecting shaft 2 such that the blunt portion
184 of the occluder may move from above the level of the target
artery 185 to a point below the level of the original vessel
sufficient to occlude the blood flow through the vessel.
[0170] Referring to FIG. 37A, a concentrically movable shaft 187 is
disposed within the shaft means 3 to which the contact members 1
are connected. In this embodiment, the target vessel 188 is
positioned directly between and parallel to the longitudinal or
greater length of the contact members 1. When so positioned, the
concentric shaft 187 within the main shaft means 3 may be pressed
downward such that the distal end 189 of the concentric shaft 187
encounters the vessel 188 and compresses the vessel, thereby
occluding the vessel 188 to substantially prevent the flow of blood
therethrough. This embodiment has the advantage that the amount of
occlusion is continuously variable by varying the force applied and
the distance by which the concentric shaft 187 is depressed
relative to the shaft means 3. FIG. 37B is a similar embodiment of
the invention whereby a means for occluding the vessel is affixed
directly proximate to the contact members 1. In the example of FIG.
37B, a pushbolt 196 is disposed on the connecting shaft 2 that
joins opposing contact members 1 and is generally positioned in a
raised portion thereof such that when the pushbolt 190 is not
deployed downward, the vessel remains in its native position when
oriented between the contact members 1. Occlusion of the vessel 188
is achieved by pressing the pushbolt 190 down until the lower
portion 191 engages the vessel 188 when the vessel 188 is disposed
between the contact members 1. This embodiment provides the ability
to occlude the vessel 188 both proximal and distal to an
arteriotomy 191 in the target vessel 188 at the site of the
anastomosis. Referring to FIG. 37C, a similar embodiment is
provided by a roller 192 or clip mechanism 193 which is affixed to
one or both contact members 1, for example by a hinge 194, which is
selectively movable, to contact the target vessel 188 at a point
either proximal or distal or both to the arteriotomy.
[0171] In addition to positioning the target vessel for performing
the anastomosis as shown in FIGS. 26A through 26C above, sutures
associated with the stabilizer may be used to occlude the vessel to
permit the anastomosis to be performed in a bloodless field.
Referring to FIGS. 38A and 38B, an embodiment of the invention may
have a flange 195 protruding from the contact member 1 to permit
silastic vessel loops or sutures 196 to be drawn about the target
vessel 197 and the flange 195. To occlude the vessel 197 the suture
196 is passed around the vessel 197 and drawn tight around the
flange 195. To facilitate occluding the vessel, a sliding shaft 198
may be used to surround the sutures 197 such that the suture lines
196 traverse the length of the sliding shaft 198 and extend out the
bottom to surround the vessel 197. In one embodiment, as shown in
FIG. 38B, the shaft 3 of the stabilizing means has a movable rod
198 having suture guides 199 disposed therein or operably
associated therewith for adjusting tension on the suture lines. The
movable rod 198 may be concentrically disposed within the shaft
means 3 such that downward pressure on the shaft means 3 and upward
pressure on the sliding shaft 196 draws tension on the sutures 196
to occlude the vessel 197.
[0172] FIG. 39 shows modifications to the upper surface of contact
members 1a, 1b of the invention wherein fixtures 201 are adapted to
provide a resting place or attachment point for other surgical
instruments such as scissors 202, forceps 203, or sutures and
suture needles 204 Preferably, the fixtures 201 are magnetic to
facilitate retaining metallic surgical instruments in conforming
contact with the upper surface of the contact member 1.
[0173] Referring to FIG. 40, the contact members 1 of the invention
and/or the shaft means 3 to which the contact members 1 are
attached may be provided with one or more flexible joints 205 that
permit positioning of either the contact members 1 or the shaft
means 3 about an axis. Preferably, the flex joint 205 may be
provided at the point where the shaft 3 engages the contact member
1 (not shown), at the point where the connecting shaft 2 engages
the shaft means 3, or at the point where the connecting shaft 2 is
attached to the contact members 1.
[0174] Thus, in the embodiment of FIG. 40, the flexible joint 205
provided at the point where the connecting shaft 2 is attached to
each contact member 1 allows the connecting shaft 2 and the shaft
means 3 to be tilted about an axis which is perpendicular to the
target vessel. The flexible joint 205 provided at the point where
the shaft means 3 is attached to the connecting shaft permits the
shaft 3 to be tilted from side-to-side relative to the connecting
shaft 2. In the embodiment of FIG. 40, or in the embodiments
described herein having hinges or flexible joints, the hinges or
flex joints may be replaced by conventional lockable joints 206, as
shown in FIG. 41, that are selectively locked and unlocked
mechanically as with forceps 207.
[0175] As can be seen, such occluders are similar to the
stabilizing contact members 1 described in several other
embodiments herein, and can be expected to provide significant
stabilization of the beating heart. These occluders can be used in
conjunction with other stabilizing means or independently. They may
be placed beside, rather than upon, the coronary artery to provide
stabilization without occlusion, if desired. In like fashion, most
of the contact members 1 of other embodiments will provide some
occlusion of blood flow if placed upon, rather than beside, the
target vessel.
[0176] As will be described in individual embodiments below, the
shaft means 3 may be attached, to or comprised of, a conformable
arm which is used to position the contact members against the
heart, and then to lock the stabilizing means in place once a
stabilizing force has been exerted. The conformable arm is flexible
and lockable and may have several configurations including a
plurality of links, segments, or universal joints in serial
configuration and having a cable fixture passed through the
interior of the links which causes the entire conformable arm to
become rigid by tightening the cable fixture. Also, the conformable
arm may be comprised of a synthetic gel or polymer contained within
a conformable cylindrical housing and which becomes rigid upon
exposure to light or heat, such as the commercially available Dymax
183-M. Where the shaft means 3 is further comprised of the
conformable arm, the conformable arm may be attached directly to
the connecting shaft 2 or the contact members 1.
[0177] Referring to FIG. 42, this embodiment of the invention is a
means for stabilizing the beating heart wherein the shaft means is
comprised of a flexible, lockable arm 208 having a plurality of
interconnecting link 209 which allow positioning of the flexible
arm 208 in every direction until the desired configuration is
achieved at which point the flexible arm 208 may be locked into
fixed configuration by tightening a cable fixture (not shown)
attached to a cable 210 running axially through the interconnecting
links 209. Each interconnecting link is comprised of a ball portion
211 and a receiving portion 212 such that the ball portion 211 fits
conformingly within the receiving portion 212. The proximate
(uppermost) end of the flexible, lockable 208 can be attached to a
stable support, or to the retractor. In a preferred embodiment, the
flexible, lockable arm 208 is a series of interconnecting links 209
having a cable 210 running through the center of each
interconnecting link 209 such that when tension is exerted on the
cable 210, the flexible, lockable arm 208 is fixed in a rigid
position. FIG. 42 also shows an embodiment of the invention wherein
the contact members 1 are comprised of a pair of substantially
parallel elements 1a, 1b which are positioned to receive a simple
snap fixture 213 which is affixed to the surface of the heart. In
this embodiment, the snap fixture 213 is positioned between the two
parallel elements 1a, 1b of the contact member 1, in order to fix
the position of the heart tissue relative to the contact members 1.
As in the above embodiment, the contact members 1 are preferably
oriented in a substantially parallel fashion with the target artery
of the anastomosis passing therebetween. The snap fixtures 213 are
affixed to the heart by a suture, wherein the suture line 214 may
then also be attached to the contact member 1 via a notch, which
may form a one-way locking mechanism to secure the suture line 214,
or may be attached to a circular post disposed in the body of the
contact member 1 (not shown). The suture line 214 then may be tied
through the notch or to the post in the contact member 1, to the
contact member 1a, 1b itself, or to the connecting shaft 2 to more
tightly secure the heart to the contact member 1. An additional
advantage of this embodiment is that the stabilizing means is
actually affixed to the cardiac tissue via the suture line 214,
such that when the heart is moving laterally or downward the artery
being stabilized remains immobile and the surface of the heart may
be lifted using the shaft means 3.
[0178] FIG. 43 shows an alternate embodiment of the flexible
lockable arm 208 attached to a retractor and having a series of
interconnecting links comprised of sphere joints 215 and
cylindrical tubes 216 and which may have a tensioning cable
traversing the length of the flexible, lockable arm as in the
design of FIG. 42. Additionally, these embodiments may have other
tensioning means such as an inflatable internal balloon 217 that
expands against the interior of the links rendering the individual
links immobile, and thereby locking the entire arm 208 into a fixed
position.
[0179] Additionally, the flexible, lockable arm 208 may be provided
by a plurality of curved or bent tubular segments 218 as shown in
FIG. 44A that are interconnected by an internal tensioning cable
210 or other tightening means. In the embodiment of FIG. 44A, the
curved or bent tubular segments 218 have interfacing surfaces 219
with teeth 220 such that when brought into conforming relationship,
the curved tubular segments 218 do not rotate relative to one
another due to the interlocking relationship of the teeth 220. See
FIG. 44B. As above, the flexible lockable arm 208 is fixed in
position by applying tension via a centrally disposed tensioning
cable 210 or other tensioning means such as a spring-loaded rod,
bolt, or wire. The interconnection between adjoining segments 218
may also be facilitated by brushings 221 that are disposed around
the wire 210 and are shaped to fit within a recessed portion 222 of
interfacing surface 219.
[0180] Referring to FIG. 45A, a continuously flexible, lockable arm
208 is provided by a hollow flexible shaft 223 having a material
224 disposed within which may become semi-rigid or stiff by a
variety of methods. In use, the contact members 1 are positioned at
the desired orientation relative to the beating heart, and the
material 224 inside the flexible shaft 223 is caused to be rendered
stiff or semi-rigid. The material 224 disposed within the flexible
shaft 223 may be an epoxy-type glue, a low melting temperature
metal with an electric heating wire 225 disposed therein, a fine
granular material or known chemicals which become semi-solid upon
exposure to light, heat, or chemical means. Where a fine granular
material is used, a mechanical compression fixture 226 or vacuum
suction may be provided to compress the material 224 to cause the
shaft 208 to become rigid.
[0181] Referring to FIG. 45B, additionally disposed within the
flexible shafts 223 may be a plurality of interconnected discs 227
which are substantially parallel and which engage the inner-surface
of the flexible shaft 223. As with the above-described embodiments,
the discs 227 may be interconnected by a wire 210 running the
length of the shaft. The plurality of discs 227 reduce shear forces
across the flexible shaft 223 and may provide separately activated
sections that provide for selective stiffening of the flexible
shaft along its length. As would be apparent to one of ordinary
skill in the art, a flexible lockable shaft may be provided by a
hybrid of the various embodiments described herein, such that
selective portions of the shaft may be rendered more or less
flexible as desired.
[0182] Referring to FIG. 46A, an adjustable shaft means 3 may also
be provided by a plurality of adjustable links 228 that are
connected to, or comprise, the shaft means 3. Preferably, the
adjustable links 228 are positioned at the distal end of shaft
means 3 and are connected to the connecting shaft 2, or directly to
the contact members 1. Referring to FIG. 46A, a plurality of curved
or bent links are provided, preferably at least three such links,
which are independently adjustable to provide multiple rotational
adjustments. The plurality of adjustable links 228 provides a
compact mechanism for positioning the contact members 1 throughout
a wide range of motion.
[0183] Referring to FIG. 46B, the links are independently rotatable
relative to the shaft means 3 and the shaft 2 connecting end
contact members 1 and to each other. The assembly formed of the
plurality of connected links may be lockable by providing an
elastomers liquid or gas shredded elastomer rubber, granulated
plastic, or tint rubber metallic ball bearings hydraulic medium
within the body of the links 228.
[0184] Referring again to FIG. 46A, an elastomeric hydraulic medium
229 is disposed within the adjustable links. The point of
interconnection between the adjustable links may have internal or
external retaining rings 230a, 230b and a means for compressing the
elastomeric hydraulic medium 229 that is operably associated with
the interior of the adjustable links 228 such that a force can be
exerted on the medium 229 to pressurize the medium to lock each
link 228 against the retaining rings 230a, 230b to fix the position
of each adjustable link 228 relative to the adjoining link, thereby
locking the entire assembly of the shaft means 3 into position.
[0185] Referring to FIG. 46C, a means for compressing the
elastomeric hydraulic medium may be provided by a pushrod 231 that
encounters the medium at its distal end, and which may be actuated
by a handle 233 attached to a screw 232 at the proximal end of the
shaft means 3. The handle 233 has a spring 234 disposed about a
piston to maintain a constant small force upon the medium 229. The
compression spring 234 in the proximal end of the shaft 3 provides
a minimal preloaded force on the pushrod 231 in the same direction
as when the handle engages the pushrod with screw 232. The force
provided by spring 234 allows repositioning of the contact members
1 in a non-locked state. Additionally, the handle 233 is threaded
into a housing 236 which is in turn threaded onto the shaft 3.
Rotating the housing 236 on the threaded shaft 3 provides for an
adjustment in the length of the shaft which in turn will adjust the
preload force that the above-mentioned spring maintains, as well
as, the axial position of the handle 233.
[0186] A flexible shaft may also be provided by the embodiment of
FIG. 47 having a plurality of substantially unstretchable strands
239 contained within a flexible outer shaft 240 that has a locking
means comprised of clamp 241 at the proximal end for compressing
the strands 239 at the proximal end and thus fixing the position of
the flexible shaft. Thus, by actuating the locking means comprised
of clamp 241 the strands 239 within the flexible shaft 240 are
compressed against one another, preventing an individual strand
from sliding relative to one another, thereby fixing the position
of the plurality of strands 239 and locking the contact members 1
in place.
[0187] The interior of the flexible shaft 240 may be provided with
several flexible substances which may be rendered solid by chemical
or mechanical means or may have sealed portions that cause the
flexible shaft 240 to become rigid or semi-rigid. For example, FIG.
48 has a flexible shaft 240 with a cable 210 running along its
length and plurality of fluid-filled lumens 242 disposed therein.
When the lumens 242 are not sealed, the contact members 1 may be
continuously positioned and the flexible shaft 240 set in any
configuration. When the desired orientation of the contact members
1 is achieved, the lumens 242 are sealed to fix the position of the
flexible shaft 240. Additionally, these lumens 242 may be
differentially pressurized or evacuated to adjust the position of
contact members 1.
[0188] Referring to FIG. 49, a fine adjustment mechanism is
provided by a plurality of threaded positioning cables 248 that
traverse threaded ports 244 of a proximal portion 243 of the shaft
means 3 and about the periphery of an end member 245 of the shaft.
The end member 245 of the shaft 3 is positioned at each of the
plurality of threaded ports 244 by turning the threaded cables 246.
By rotating the cables by knobs 247, the portion of the end member
245 of the shaft is moved either upward or downward relative to its
original position.
[0189] FIG. 50A shows the interior of a shaft means 3 of the
invention having a spring-loaded mechanism 249 in the proximal
portion thereof for damping the vertical motion of the proximal end
of an inner shaft 251. A spring 252 is mounted within the interior
of the proximal portion 253 of an outer shaft 254 such that when
the contact members 1 are lowered onto the beating heart, the
proximal end 250 of inner shaft 251 gently compresses the spring
252. The outer shaft 254 may be positioned downward until a point
of resistance is met at which the beating heart achieves adequate
stabilization. At that point, the outer shaft 254 may be fixed in
position, i.e. by attaching to the retractor or other stabilized
support 255 while the inner shaft 251 may move up and down in a
vertical direction. The oscillation of the inner shaft 251 is
dampened by the spring 252 mounted in the proximal portion 253 of
the outer shaft 254 or may be rendered motionless by lower
positioning of the outer shaft 254 relative to the surface of the
beating heart.
[0190] As shown in FIG. 50A, the spring mechanism 249 may also be
mounted at the distal portion of the shaft means 3 and the spring
252 may be external to a central shaft 256. An additional
configuration having a damped vertical motion is provided by a
fluid dampening mechanism consisting of a chamber 257 with a seal
260 having a plunger 258 for moving therein wherein said plunger
has a piston 261 having an annular seal 261a thereabout, such as a
rubber O-ring seal, that engages the internal portion of the
chamber 257 to substantially seal the passage of fluid. Piston 261
has one or more orifices 269 to restrict the flow of fluid
therethrough. Additionally, inside plunger 258 is a one-way valve
such as a spring-loaded ball 258a within a bypass passage 258b. As
an upward vertical force is imparted upon the central shaft 250,
the fluid dampening mechanism restricts the ability of the central
shaft 250 to move upward, while its downward motion is relatively
unrestricted, due to fluid flowing through bypass passage 258b.
[0191] Referring to FIG. 51A, the shaft means 3 depicted therein
has an adjustable central shaft 263 with a fine adjust capability
provided by a thumbscrew 264 which is rotatable about a threaded
portion 265 of the central shaft 263 and which is connected at the
most distal end to the contact members 1. Independent rotation of
the central shaft 263 is prevented by a stop 268. As in FIG. 1, the
shaft of this embodiment may be rotatably attached to a portion of
a retractor or stabilized support 266 by passing the shaft through
a ball and socket joint 267.
[0192] Referring to FIG. 51B, the contact members 1 are attached to
a partial portion of the shaft means 3 comprised of an outer sleeve
269 that extends to engage a second shaft 270 having a plurality of
splines 271 about the exterior. A first internal shaft 272 is
attached to a ball joint. 273 operably connected to the contact
members 1. The first internal shaft 272 is disposed inside both the
outer sleeve 269 and the second shaft 270 and has threads 274 to
permit adjustment by a handle 275 (which may be removable). At the
end of the threaded internal shaft 272, the ball joint 273 allows
the contact members 1 to rotate at the base of the shaft means 3.
The second shaft 270 is engaged through the outer sleeve 269 by the
splines 271 to keep the ball joint 273 from rotating. A circular
clip 275 has inner ridges 276 that pass through the outer sleeve
260 and maintain the ball joint 273 in a fixed position.
[0193] Referring to FIG. 52, a method for providing continuous and
adjustable positioning of the contact members 1 of the invention
may be readily provided by a malleable shaft 277 which is attached
to the contact members 1 and which may slide and be molded by hand.
In particular, the malleable shaft 277 may slide through a fixture
278 attached to a stable support such as a retractor blade 279 used
to open the surgical incision. The vertical positioning of the
device may be achieved by a handle 280 which is manipulated from
outside of the incision and causes a vertical portion 231 of the
malleable shaft 277 to slide through the fixture 278.
[0194] Referring to FIG. 53, an embodiment for the shaft means 3 of
the invention is shown having a plurality of linked members 282,
each of which is connected to the adjacent linked member 282 by a
hinge 283, and a torsion spring connected to each hinge (not shown)
and which are interconnected by a cable 284 connected to each
linked member 282, preferably at an attachment point 285 adjacent
to the hinges 283. By providing a plurality of discrete
interconnected linked members 282 with an arcuate shape, and by
providing an interconnecting cable 284, a curved shaft means 3 is
provided with the ability to coil and uncoil as the tension is
exerted, released, or reversed, on the cable 284. Preferably, the
most distal linked member 282 and the end of the cable 284 is
affixed to contact member(s) in any of the several embodiments
described previously.
[0195] To take advantage of the minimally invasive procedures
enabled by the invention, the positioning of the contact members 1
by manipulation of the configuration of the shaft means 3 may be
achieved remotely, i.e., from outside the incision, by any of a
variety of mechanisms attached to and operably associated with the
shaft means 3. Referring to FIGS. 54A through 54C, remote
manipulation of the positioning of the contact members 1 may be
provided by a shaft means 3 having a ball joint 286 at the distal
end thereof which is connected to the contact members 1 or the
connecting shaft 2. Continuous positioning of the ball joint 286
may be provided by a plurality of cables 287 which are affixed to
the ball joint at opposing points 288 at the exterior surface of
the ball joint 286. The ball joint 286 is maintained in a socket
289 at the distal end of the shaft means 3. The shaft means 3
itself may be rigid or flexible, or may be fixed into a
pre-determined position by the surgeon depending on the clinical
environment. Additionally, the shaft means 3 may be comprised of a
plurality of shafts, including an inner flexible shaft 290
contained within a rigid shaft 291 wherein the flexible shaft 290
extends above the rigid portion, terminating at the positioning
handle 292. The contact members 1 are positioned by means of the
plurality of cables 287 attached to the ball joint 286. The
plurality of cables 287 runs from the ball joint 286 through the
length of the shaft means and terminate in a positioning handle 292
at the proximal end of the shaft means 3. The shaft 3 may be of any
convenient length but is preferably long enough to extend the
positioning handle 292 to a point. sufficiently beyond the incision
that manipulation of the position of the contact members 1 does not
interfere with the surgeon's ability to visualize the surgical
site. Thus, each cable 287 has a distal portion affixed to the ball
joint 280, and a proximal portion affixed to a positioning handle
292 having the cables attached thereto. In one configuration, the
plurality of positioning cables 287 are affixed about a plurality
of attachment points 293, respectively, on the positioning handle
292.
[0196] In the embodiment of FIGS. 54B and 54C, the positioning
handle 292 has a recessed area 295 in the bottom surface and a post
294 disposed in the recessed area 295 about which the cables 287
are affixed at several points. The most proximal portion of the
positioning handle 292 is adapted to be grasped by the hand and may
be rotated about the post 294 to provide selective tension on the
cables 287, thereby repositioning the contact members 1 at the
distal end of the shaft means 3.
[0197] As is apparent from the foregoing description, an important
function of a shaft means is to selectively place the contact
members at the appropriate site on the beating heart, while
providing sufficient flexibility and positioning adjustability for
different clinical situations and for different surgical access
techniques. Also, the shaft is typically mounted or attached to a
stable support at a proximal end and typically at a point outside
the patient's chest. Thus, it is advantageous to provide a shaft
means having the ability to be positioned in several
configurations, particularly relative to a stable support such as a
surgical retractor or access platform which is used to provide
access to the beating heart.
[0198] Referring to FIGS. 55A and 55B, because the available access
and working space for the surgeon may be limited, certain
embodiments of the invention may be contained substantially within
the chest cavity. Preferably, such a stabilizing means is connected
to the rib retractor and may be affixed to one or both sides of the
opening created by spreading the ribs using the rib retractor.
[0199] Referring to FIG. 55A, rib retractor 296 is shown in an open
position whereby blades 297 engage and spread the ribs. A pair of
stabilizing bars 298 having a conventional ratchet means 299
attached at the end thereof are positioned beneath the retractor.
The ratchet means 299 is comprised of a plurality of teeth 300 on
the stabilizing bars 298 and a ratcheting aperture 301 permitting
one-way passage of the stabilizing bars 298 unless released by a
release mechanism. The stabilizing bars 298 are curved downward
such that as the bars are advanced through the ratchet means 299,
the lowermost portion of the stabilizing bars 298 engages the
beating heart 301a proximate to the anastomosis site.
[0200] Referring to FIG. 55B, the orientation of the portion of the
stabilizing means which engages the heart relative to the rib
retractor 296 is similar to the embodiment shown in FIG. 55A. In
this embodiment, a contact member 1 is attached on opposite ends to
at least two malleable supports 302 which are in turn attached to
the rib retractor 296. The malleable supports 302 are preferably
made of stainless steel bands which are woven in a mesh or have a
repeating serpentine configuration to allow for substantial
extension into the chest cavity. This configuration yields a
malleable support 302 with sufficient tensile strength to maintain
a stabilizing force at the anastomosis site while allowing the
surgeon to manipulate the malleable supports 302 within the chest
cavity to achieve the desired orientation relative to the beating
heart.
[0201] As noted above, at the upper end of the shaft means 3, the
shaft means 3 may be attached to a fixed support which may be any
surface or structure which does not move with the beating heart.
For example, the shaft means 3 may be attached to a fixture on the
retractor system used to spread the ribs for access to the heart or
may be attached to a fixed structure such as the surgical table or
associated aperture which is not connected to the patient. In a
preferred embodiment, the shaft means 3 is directly attached to a
component of the retractor system which is designed to receive the
shaft means 3 and to maintain the position and orientation of the
shaft means 3 during the procedure.
[0202] Referring to FIGS. 56A and 56B, an adjustable slide
mechanism is provided to the shaft means 3 such that the shaft
means can be continuously positioned relative to a retractor. For
example, in FIG. 56A, a curved shaft 303 traverses a ball joint 304
disposed at the end of an adjustable arm 305 which connects the
shaft means to the retractor 306 and is lockable relative to the
retractor 306. The curved shaft 303 traverses the ball joint 304,
as described previously, and is positioned by sliding the shaft 303
relative to the ball joint 304, providing the ability for the
contact members 1 to be positioned at any point within a given arc
as defined by the flexible shaft 303. Also, the entirety of the
curved shaft 303 may be positioned in a perpendicular direction
away from the length of the retractor blade 307 using the
adjustable arm 305. FIG. 56B shows a top view from A-A of the
adjustable arm 305 which may have a slot or groove formed in the
body thereof allowing continuous positioning until the arm is fixed
in position by a locking mechanism 308. Thumbscrew 312c locks the
position of ball 304 in member in place.
[0203] In FIG. 56C, the shaft means 3 is comprised of a pair of
parallel shafts 309 and 310 which slide around an axle 311 disposed
in a tightening mechanism 312 affixed to the retractor 313. The
position of the shaft means 3 relative to the retractor 313 is
adjustable by sliding the shaft means 3 along the axle 311. Moving
handle 311a causes a corresponding motion in the contact members 1.
Tightening thumbscrew 312c locks clamp members 312a, 312b onto port
312d and shafts 309, 310 simultaneously.
[0204] Referring to FIG. 57, an adjustable arm may be provided for
continuously adjusting the distance between the retractor or other
stable support and the shaft means of the means for stabilizing the
beating heart of the invention. At one end of the adjustable arm,
the shaft means 3 traverse a ball joint 314 which is contained in a
socket 315 formed in the body of the adjustable arm. The tightness
of the ball joint 314 may be adjusted by tightening a shaft 316
affixed to the socket 315 and which passes through the body 318 of
the adjustable arm. The tightening shaft 316 which is in turn
connected to a rotating knob 319 that may tighten or loosen the
ball joint 314 by tightening the socket 315 via the tightening
shaft 316. The distance between the shaft means 3 and the ball
joint 314 is also adjustable relative to the stable support 320 by
virtue of a slit or groove 321 formed in the body of the adjustable
arm. A locking mechanism 322 is disposed within the groove 321 such
that actuating a locking handle 323 fixes the position of the
adjustable arm by tightening the locking mechanism 322 about the
groove 321.
[0205] FIGS. 58A, 58B, and 58C are multiple segment shaft means 3
having alternate configurations to permit adjustable positioning.
FIG. 58A has an elbow joint 324 with a hinge attaching upper and
lower dual shaft members 325a, 325b, and 326a, 326b, such that the
upper and lower shafts members are continuously positioned relative
to a retractor or other stable support 327: The assembly may be
attached to the retractor and the lower dual blade shaft members
325a, 325b are attached to the contact members by rotating joints
328 while the upper dual shaft members 326a, 326b are attached to
the support by a second rotating joint 329. FIG. 58B has two shafts
which are positioned to extend in a horizontal plane by extending
from beneath a retractor blade 330 and by rotating around at least
one circular joint 331 disposed between a first and second shaft
332 and 333. At the end of the second shaft 333, the contact
members 1 may be provided with a third vertical shaft 334 having a
ball joint 335 disposed at a proximal end thereof and which is
affixed to the second shaft member 333.
[0206] One particularly useful feature of the shaft means of the
invention is the ability to extend the distal end of the shaft in a
continuous or telescopic fashion such that the contact members can
be continuously positioned downwards relative to the proximal end
of the shaft that is in turn attached to a retractor or other
stable support. The degree of downward extension may be provided by
several mechanical embodiments. FIG. 58C is a telescoping shaft
member 336 having a lower shaft 337 concentrically oriented within
an upper shaft 338 and a locking means 339 for fixing the position
of the lower shaft 337 relative to the upper shaft 338.
Additionally, the contact members 1 may be positioned by pivot 339
located at the proximal distal ends of the lower shaft 337. The
upper shaft 338 may also be positioned relative to the retractor
blade 330 by a tilting mechanism 340 that adjusts the angle of the
upper shaft 338 relative to the retractor blade 330.
[0207] Referring to FIGS. 59A, 59B, and 59C, the stabilizing means
of the invention may be provided by a plurality of adjustable
attachments that affix the proximal end of a shaft or shafts to a
retractor. For example, in FIG. 59A, a plurality of telescoping
shaft means 341 are affixed to several pivoted joints 342 or hinges
on a retractor blade 343 such that the contact members 1 can be
continually positioned in three dimensions relative to the
retractor blade 343 which grips one edge of an incision. When
retracted, the contract members 1 are contained entirely within a
recessed housing 343a formed in the retractor blade 343.
[0208] In the embodiment of FIG. 59B, a lockable rotatable arm 344
is provided that may be locked or unlocked to be positioned
vertically by a first hinge 345 and to swing or rotate around a
second hinge 346 wherein both hinges are mounted in a retractor arm
or a retractor blade 343.
[0209] In FIG. 59C, the shaft means has an adjusting knob 347
affixed to the proximal end of a telescoping shaft means 348 at a
point along the retractor arm 349 or the retractor blade 343. By
loosening the adjusting knob 347, the telescoping shaft means 348
may be extended or retracted relative to the retractor arm 349 and
the retractor blade 343 thereby allowing the contact members 1 to
swing into position to be brought into contact with the beating
heart.
[0210] In the embodiment of FIG. 60, a flexible central shaft 350
having a handle 351 at the most proximal end is disposed within at
least one shaft guide 352, and preferably a series of shaft guides
352, 353, and 354. The handle 351 is adapted to be held by the hand
and allows both rotation of the flexible central shaft 350 and
positioning of the contact members 1 by extension or retraction of
the handle 351. Any of the series of shaft guides 352, 353, and 354
may be straight or formed to have a predetermined curve to alter
the direction of the central shaft 350. A proximal shaft guide 354
may be integral with a retractor 355 used to open a surgical
incision. A particularly preferred low profile embodiment of FIG.
60 has a shaft guide 354 integrally associated with a cross-member
356 that connects the arms of retractor blades 357. The shaft means
3 at the distal end of the central shaft 350 may be straight or
curved and rigid or flexible as desired. To fix the position of the
central shaft 350, a lock mechanism 358 is provided, preferably at
a proximal portion of the central shaft 350, to fix the position of
the central shaft relative to the shaft guides 352, 353, and
354.
[0211] Referring to FIG. 61, as noted above, attachment to a rib
retractor is a preferred technique for fixing the position and
orientation of the stabilizing means. The stabilizing means of the
invention may therefore advantageously attached to a fixture
attached to a rib retractor 359 or may be configured to be directly
incorporated into the body of a portion of the rib retractor 359. A
surgical rib retractor 359 is generally comprised of a body 360
having blades 361 attached thereto, which engage the ribs and
spread the ribs when the retractor 359 is operated to move the
blades 361 apart from one another. The space created by the
retracted blades 361 provides access to the heart. Thus, once the
retractor 359 is locked into the open position, the stabilizing
means may be applied to the heart and a stabilizing force
maintained at the site of the anastomosis by fixing the position
and orientation of the shaft means 3 relative to the rib retractor
359. Referring again to FIG. 61, the shaft means 3 may traverse the
width of the body 360 of the retractor 359 and is held in place by
an upper plate 362 and a lower plate 363 having circular openings
364 therein through which the shaft means 3 passes and which
maintain the position of a sphere 365 positioned between the upper
plate 362 and lower plate 363. The size of the openings 364 is
larger than the diameter of the shaft means 3 but smaller than the
largest diameter of the sphere 365. Thus, the shaft means 3 passes
through the sphere 365 and may pivot about a point approximately at
the center of the sphere 365.
[0212] Referring to FIG. 62, the stabilizing means of the invention
may be provided by a shaft means 3 that extends from a cross-arm
366 connecting the individual arms 367 of a surgical retractor such
that the shaft means 3 extends between the arms 367 attached to the
retractor blades 368 and below the level of the retractor blades
368 such that the contact members 1 and separate shaft 369 is
positioned beneath the level of the retractor blades 368 and is
generally contained within the chest cavity. This embodiment is a
low profile design wherein a portion of the shaft means 3 extends
into the chest cavity and has a second substantially horizontal
shaft 369 extending from the distal end 370 thereof.
[0213] Referring to FIG. 63, the stabilizing means of the invention
may advantageously be provided with a rib locking mechanism 371
affixed to either side of a rib 372 to form a stable support for
shaft means 3 that extends from the rib locking mechanism 371 into
the chest cavity. The rib locking mechanism 371 is comprised of an
adjustable post 373 preferably disposed within a slot 376 formed in
the body of the rib locking mechanism 371 and is positioned between
two adjacent ribs 372, 373 and a blade 374 affixed to the opposite
side of the rib 372 most adjacent to the incision. The position of
the blade 374 is adjustable relative to the post 373 by sliding the
mechanism 371 along the slot 376 and fixing it in place with a
locking latch 373.
[0214] As noted herein, the embodiments of the stabilizing means of
the invention may also be used to position the heart to facilitate
performing the bypass surgery or any other cardiac procedure where
the position of the beating heart may be adjusted. Referring to
FIG. 64, the embodiment of FIG. 63 may be utilized as a heart
positioning device requiring only the modification that the shaft
means 3 affixed to an identical or equivalent rib locking mechanism
371a and the contact members 1 have a length and tensile strength
such that the contact members 1 can maintained in a position about
the periphery of the beating heart as desired.
[0215] In combination with the several designs for contact members
and related features described previously herein, the configuration
and construction of the element which is attached to the contact
members principally the shaft means, may partially comprise the
contact members and may be provided in several alternative designs
without departing from the spirit of the invention. As indicated
previously, certain variations may depend on the surgical demands
of a particular procedure, and will depend on the nature of the
surgical incision(s) used to access the beating heart. For example,
some embodiments of the invention are particularly useful where a
minimally invasive incision is created, and the procedure is
performed by introducing instruments through a cannula or a hollow
shaft that provides access to the heart. FIGS. 65A through 65D show
an embodiment of the invention whereby a means for stabilizing the
beating heart is provided that is integral or closely associated
with a hollow shaft 386 that defines a surgical field around the
site of the anastomosis. In FIG. 65A a hollow shaft 386 is provided
having a lower cylindrical portion 387 that splits into two
semi-cylindrical portions 388 and 388b that define the surgical
field for an anastomosis of a target vessel 389.
[0216] Preferably, the bottom surface 390 has an opening 391
through which the vessel 389 passes such that the vessel lies
within the opening 391 and within the larger space created by
splitting of the hollow shaft 386 to create the surgical field. In
this embodiment, instruments may be introduced either through the
hollow shaft portion 386 of the device or through the split portion
of the lower portion 387 of the shaft to provide stabilization and
access to the vessel 389. The opening action of the lower portion
387 of the shaft may be provided by a rotating shaft means 3 which,
when rotated, forces the lower portion 387 to split into the
semi-cylindrical portions 388a and 388b.
[0217] Referring to FIG. 65B, a unitary hollow shaft 392 may be
provided that contacts the beating heart about the bottom surface
390, to provide the stabilization function, and has a plurality of
openings 393 disposed in the body 394 thereof. Preferably at least
one passage 395 is provided in the bottom surface 390 such that the
target vessel 389 may be disposed within the passage 395. A second
passage 396 may be provided in the bottom surface 390 of the
unitary hollow shaft 392, preferably at an opposite end, such that
the vessel may pass through the openings 395, 396, or where a
single opening is provided (not shown) the edge of the bottom
surface opposite the opening 395 acts as an occluder. Larger
openings 397 in the body of the unitary shaft 392 may be provided
to enable the surgeon to have access to the target 389 vessel
through the body of the unitary shaft 392.
[0218] FIG. 65C is a hollow shaft element 398 having formed therein
a pair of contact members 1 of the type described previously, but
which fold out from the body 399 of the shaft by virtue of a hinge
or pivot 400 at the lower portion 401 of the shaft element 399. By
folding out the contact members 1, which are maintained
substantially integral to the shaft element during insertion of the
shaft element 398 through a surgical incision, the contact members
1 engage the surface of the beating heart and provide the
stabilization function. The surgeon may introduce instruments
through the hollow portion of the shaft element 398, or from
another direction to achieve the anastomosis.
[0219] Referring to FIG. 65D, the application of the stabilizing
force need not be applied directly below the surgical field created
by the shaft element 398. The embodiment of FIG. 65D has an annular
ring 402 formed in the bottom portion 391 of the shaft element 398
and that may rotate about the axis provided by a rod 403 or the
shaft means 3 passing through the wall of the shaft element 398,
and which is affixed to the annular ring 402. By rotating the rod
403, the annular ring 402 rotates out from under the bottom 391 of
the shaft element 398, and may be positioned to contact the surface
of the beating heart in an annular fashion adjacent and tangent to
the shaft element 398. As with other embodiments described herein,
the annular ring structure 402 that applies the stabilizing
function may have at least one passage 464 formed in the bottom
surface such that the vessel 389 may be positioned therein. The
passage 464 may pass through the entirety of the ring 402 making it
a "C" or "V" shaped contact member (not shown), which will allow
easy removal from the field after construction of the anastomosis
fastening the graft to the heart. Alternatively, the ring structure
402 may be cut or broken for removal if necessary.
[0220] Referring to FIG. 66, this embodiment of the stabilizing
means is comprised of an elongated sheath member 405 which wraps
around the heart in a strap-like fashion to restrict the motion of
the heart. This embodiment may be used with a thoracotomy providing
surgical access, but is particularly useful when access to the
beating heart is provided by a sternotomy. The sheath member 405 is
positioned to surround the heart and manipulated so that each end
of the sheath member 405 extends out of the chest cavity through
the sternotomy. If desired, at least one end of each sheath member
405 is attached to a retractor 406 to secure the position of the
sheath member 405. The sheath member 405 may have a plurality of
support attachments 407 which engage the exterior of the heart to
hold it in place. At the point where the support attachments 407
contact the surface of the heart, the support attachments 407 may
have friction means 4 (not shown) attached to the surface which is
in direct contact with the heart. The support attachments 407 may
have or be comprised of fluid-filled members 408 which cushion the
heart against the sheath member 405, and absorb the motion of the
heart while it is stabilized. Where the sheath member 405 has one
or more fluid-filled members 408, the sheath member 405 may also
include at least one lumen 409 for introduction of air or a
biocompatible fluid to the inflatable members 408, which may be
inflated separately or simultaneously. In the former instance, a
separate lumen 409 is provided for each inflatable member 408. The
insertion of the sheath member 405 into the chest cavity may be
performed while the inflatable members 408 are deflated and is
achieved manually or by a conventional guide and/or guide wire.
Each of the support attachments 407 may be permanently attached to
the sheath member 405 or may slide along the length of the sheath
member 405. Alternatively, alone or in combination with other
inflatable members, the inflatable member 408 is positioned
immediately proximate to the target coronary artery to achieve a
more localized stabilization. Thus, the inflatable members of the
invention may lie next to, or may surround, the heart of the target
coronary artery and may have openings or apertures placed in the
body thereof through which surgical procedures are performed. An
additional stabilizing force may be applied when the inflatable
member 408 fills the space between the heart and the enclosing
structure, such as the pericardial ling or the back of the ribs.
When the inflatable member 408 is appropriately inflated, the
target artery site may be pressed against a proximate stabilizing
structure, such as contact member 1, the back of edge of the
surgical incision. The fluid-filled or inflatable cushioning,
stabilizing, or positioning means could also be applied via a
rigid, malleable, deformable, or removable shaft, handle, mounting,
or inflation means.
[0221] Similarly, referring to FIG. 67, a strap 410 may be provided
which is arranged to pass over opposite retractor blades 411, to
pass underneath the heart, and which may be mounted at both ends to
a crank 412 for selective movement of the strap 411. By turning the
crank 412, or by otherwise manipulating the position of the strap
411, the heart may be rotated for selective positioning or to
provide access to various regions of the heart. The cranks 412 are
advantageously attached to the retractor used to maintain spreading
of the ribs in a minimally invasive thoracotomy.
[0222] As noted above, in addition to stabilization of the beating
heart, the devices and methods the heart. Additionally, as shown in
FIG. 68, an alternate to a continuous strap 411 is shown in FIGS.
68A, 68B, and 68C and is comprised of a substantially flat,
flexible sheet 413 positioned under the heart. One side of the
sheet 413 may have a hydrogel 414 coating, or a coating of a
similar material that adheres to the epicardial surface.
Preferably, the other side of the sheet 413 is smooth. In a
preferred embodiment, two sheets 413 are joined at their respective
edges to form an interstitial space (not shown) therebetween.
Perfusion of the interstitial space with fluid softens the hydrogel
414, allowing ready repositioning or removal of the sheets 413.
[0223] Depending on the nature of the surgical procedure, it may be
desirable to lock the contact members 1 in place by manipulating
their position from a location remote from the surgical field. In
the embodiment of FIG. 69, a plurality of telescoping shafts 415
are provided which engage a contact member 1 at their most distal
end. Preferably, each telescopic shaft 415 is affixed to a point on
the retractor blade 416, thereby allowing the telescopic shafts 258
to be collectively adjustable to position the contact members 1 at
any point within the range of movement of the telescoping shafts
415 within the surgical field. At the most proximal point of each
telescopic shaft 258, the shaft is affixed to the retractor blade
416 by virtue of a hydraulic actuator 417 that fixes the
orientation of each telescopic shaft 415 relative to the retractor
blade 416. Each hydraulic actuator 417 is attached to a lock valve
418 via non-expanding hydraulic hoses 419. Typically, the lock
valve comprises a reservoir 420 and a hand-activated switch 421 for
closing the lock valve 418 to lock the hydraulic actuators 417 into
position. Any number of telescopic shafts 415 may be provided,
however, it is preferable that a plurality of mounting points are
available at various locations on the retractor blade 418 such that
the surgeon can individually attach several, preferably at least
three, telescopic shafts 415 to the retractor blades 416 at the
locations best suited for each surgical procedure.
[0224] Referring to the embodiment of FIGS. 70A through 70D, a
stabilizing means is provided with a shaft means 3 comprised of a
plurality of arms connected by joints having selectively placed
friction surfaces associated therewith that freeze the joints and
adjustable arms into a set configuration when the contact members
are displaced upwards by the motion of the beating heart. Referring
to FIG. 70B, the retractor blade 416 has a locking mechanism 422
with an internal cam shaft 422a actuated by a handle 422b that
expands a first curved leaf spring 422c to fix the position of a
first shaft 424 relative to the retractor blade 416. As shown in
FIG. 70A, the first shaft 424 is attached to a first friction joint
425 permitting rotation of the joint about an axis perpendicular to
first shaft 424. Referring to FIG. 70C, the friction joint 425 is
comprised of a lower housing 426 affixed to the first shaft 424 and
an upper housing 427 affixed to a second shaft 428 which may be a
discrete cylindrical shaft as the first or may be an extension of
the housing of the friction joint 425. A ball pivot 429 is
positioned between the upper 427 and lower housing 426 to allow the
individual housings to rotate about each other. Either the upper
427 or lower 426 housing has disposed therein a friction surface
430, and the opposite housing has a friction engaging means such as
teeth 431. When either housing is displaced by tilting about the
ball pivot 429, the friction surface 430 contacts the friction
engaging means 431 and freezes the position of the friction joint
425. The second shaft may be connected to a second friction joint
432 having an equivalent construction to the first.
[0225] Referring to FIGS. 70A and 70D, a rotatable shaft means 433
is comprised of a central rod 434 disposed within a housing 438
having a ratcheting mechanism formed from tongues 435 engaging
teeth around said central rod 434 to fix the rotatable position of
the rotatable shaft means 433. The rotatable shaft means 433 is
connected to the contact members 1, for example, by a hinge 436
having a shaft 439 resistant to rotation by teeth (not shown)
engaged by molded tongues 437.
[0226] In the embodiment of FIGS. 71A through 71D, a retractor
blade 440 is adapted to receive a clip into which is inserted a
flexible slide having a contractible shaft means at the distal end
thereof and means for extending the contractible shaft. Referring
first to FIG. 71C, the assembly includes a C-shaped clip 441 for
attaching the stabilizing means to the retractor blade 440. The
clip has at least one groove 442 adapted to fit within a guide 443
formed in the retractor blade 440. The body of the clip 441 also
has a slot 444 around the outside of the curved portion as shown in
FIGS. 71A and 71B and in phantom in FIG. 71C for insertion of a
flexible slide 445. FIG. 71D shows the flexible slide 445 that fits
inside the slot 444 formed in the clip 441 such that the flexible
slide enters the clip 441 through the slot 444 and curves around to
conform to the shape of the clip 441. A block 440 is mounted at the
distal end of the flexible slide 445.
[0227] An extendable shaft means 447 is attached to the block 446
and has an unexpandable hydraulic tube 448 affixed thereto which is
in fluid connection with a syringe 449 or other such fluid
containing apparatus to apply hydraulic pressure through the tube
448 to extend the shaft means 447. Preferably, the syringe has a
one-way valve 450 with a release valve 451 such that hydraulic
fluid pressure is applied to progressively advance the extendable
shaft means 447, while the one-way valve 450 prevents the
extendable shaft means 447 from contracting. Upon completion of the
procedure, the hydraulic pressure is released by activating release
valve 451.
[0228] Referring to FIG. 71A, the surgeon would first insert the
clip 441 onto the retractor blade 440 by inserting the flexible
slide 445 into the slot 444. The flexible slide 445 is thereby
advanced from the top of the clip 441 through to the bottom until
the extendable shaft means 447 is in position to be extended to
bring the contact members 1 into conforming engagement with the
heart. With one hand, i.e., via the syringe 449, fluid is injected
into the extendable shaft 447 to cause the contact members 1 to
engage the heart. Note also that the guide 443 in the retractor
blade 440 may extend the length of the blade 455, allowing
selective positioning of the clip 441 along the blade 440.
[0229] Referring to FIG. 72, the means for stabilizing the beating
heart of the invention is shown in use together with a rib
retractor 452 and additional apparatus 453, 454 which may be used
during the beating heart CABG procedure. In use, the blades 455 of
the retractor separate the ribs, thereby providing an access space
for the introduction of surgical instruments, including the
stabilizing means of the invention. The stabilizing means is thus
brought into contact with the heart such that the contact members 1
are proximate to the target artery 456. A stabilizing force is
exerted in an amount sufficient to minimize motion of the beating
heart, including fixing the stabilizing means in place, preferably
by attachment to the rib retractor 452.
[0230] Referring to FIG. 73, the stabilizing means is comprised of
a pair of rectangular, substantially planar contact members 1,
which are placed proximate to a target artery 456. The shaft means
3 is conformable such that it may be conveniently attached to the
rib retractor 452. As shown in FIG. 73, the surgeon may readily
adjust the orientation and positioning of the connecting shaft 2
and the contact members 1 relative to the shaft means 3 while the
stabilizing means is in continuous contact with the heart by
manipulating the thumbscrew 457 at the proximal end of the
instrument. FIG. 74 shows a later stage of the procedure at a point
where the anastomosis is being completed by suturing at target
artery 456. The stabilizing means thus maintains a stabilizing
force at the anastomosis site for the duration of the
procedure.
[0231] As described above in several embodiments of the invention,
the stabilizing means may advantageously be integrated with a
related surgical device such as a retractor that is used to spread
the ribs in preparation for the cardiac surgery. FIG. 75 is an
embodiment of the invention having a pair of shaft means 3
integrated with the arms of a retractor 459 suitable for spreading
the ribs in a minimally invasive cardiac surgery. The stabilizing
means are comprised of shafts having adjustable links 459 as
previously described that provide for positioning of the contact
members 1. The shaft means 3 also traverse ball joints 460 that are
directly affixed to the arm 458 of the retractor blade, and
terminate with adjustable handles 460 for locking the position of
the shaft means 3 and contact members 1 in place.
[0232] As mentioned previously, it is the goal of the present
invention to provide an apparatus, or collection of apparatus, to
facilitate completing a minimally invasive CABG procedure on the
beating heart. Thus, each of the devices disclosed herein is
preferably provided in an integrated kit, having several individual
instruments packaged therein to provide the surgeon with each of
the instruments necessary to complete the anastomosis on the
beating heart. Since it is intended that the means for stabilizing
the beating heart as described herein, will be introduced directly
into the thoracic cavity, and brought into direct physical contact
with the beating heart, it is necessary that each of the devices
disclosed herein be subjected to the sterilization techniques
suitable for other surgical instruments. It is particularly
preferred that a substantial portion of the devices described
herein be formed of a biocompatible and sterilizable plastic and
maintained in a sterile container completely enclosing the
instrument whereby the container provides a barrier against
microorganisms and wherein the stabilizer means of the invention
and the container in which the instruments are packaged are
sterilized. Sterilization of the container and the instruments
contained therein may be provided by conventional sterilization
methods such as ETO gas, high temperature and pressure, or gamma
radiation. Preferably, the container is a sealable flexible bag
that may be sterilized either before or after having the
instruments of the invention sealed therein.
[0233] The particular examples set forth herein are instructional
and should not be interpreted as limitations on the applications to
which those of ordinary skill are able to apply this invention.
Modifications and other uses are available to those skilled in the
art which are encompassed within the spirit and scope of the
following claims.
* * * * *