Source: http://www.docstoc.com/docs/56926452/Method-And-System-For-Organ-Positioning-And-Stabilization---Patent-7507235
Timestamp: 2014-10-21 16:46:17
Document Index: 502052521

Matched Legal Cases: ['art.\n2', 'art.\n3', 'art.\n6', 'art.\n7', 'art.\n9', 'art.\n51', 'art.\n54', 'art.\n55', 'art.\n58', 'art.\n59', 'art.\n61', 'art.\n103']

Method And System For Organ Positioning And Stabilization - Patent 7507235
United States Patent: 7507235
7,507,235
This invention provides a system and method for positioning, manipulating,
holding, grasping, immobilizing and/or stabilizing a heart including one
or more tissue-engaging devices, one or more suction sources, one or more
fluid sources, one or more energy sources, one or more sensors and one or
more processors. The system and method may include an indifferent
electrode, a drug delivery device and an illumination device. The
system&#39;s tissue-engaging device may comprise a tissue-engaging head, a
support apparatus and a clamping mechanism for attaching the
tissue-engaging device to a stable object. The system may be used during
various medical procedures including the deployment of an anastomotic
device, intermittently stopping and starting of the heart, ablation of
cardiac tissues and the placement of cardiac leads.
Keogh; James R. (Maplewood, MN), Jahns; Scott E (Hudson, WI), Colson; Michael A. (Chanhassen, MN), Guenst; Gary W. (Collegeville, PA), Olig; Christopher (Eden Prairie, MN), Pignato; Paul A. (Stacy, MN), Montpetit; Karen (Mendota Heights, MN), Daigle; Thomas (Corcoran, MN), Gubbin; Douglas H. (Brooklyn Park, MN), O&#39;Neill; William G. (Maple Grove, MN), Jolly; Katherine (Shoreview, MN)
10/156,315
606/32  ; 128/898
128/898 600/37
Wakikaido et al.
2004/0249368
2005/0203561
2005/0203562
WO 00/72912
Mien-Cheng Chen, M.D., et al., &quot;Radiofrequency and Cryoablation of Atrial Fibrillation in Patients Undergoing Valvular Operations,&quot; Annals of Thoracic Surgery, 1998:65:1666-1672. cited by other
Akira T. Kawaguchi, et al., &quot;Factors Affecting Rhythm After the Maze Procedure for Atrial Fibrillation&quot;, 1998; vol. 78, No. 5, pp. 1288-1296. cited by other
Enrique, J. Berjano, et al., &quot;Bipolar Electrosurgery with Long Electrodes for RF Coagulation of Atrial Tissue,&quot; Proceedings 19.sup.th International Conference--IEEE/EMBS Oct. 30-Nov. 2, 1997 Chicago, Ill. USA, pp. 2528-2530. cited by other
Yoshio Kosakai, M.D. et al., &quot;Cox Maze Procedure for Chronic Atrial Fibrillation Associated with Mitral Valve Disease,&quot; The Journal of Thoracic and Cardiovascular Surgery, 1994; vol. 108, No. 6, pp. 1049-1055. cited by other
Guiraudon et al., &quot;Surgical Ablation of Posterior Septal Accessory Pathways in the Wolf-Parkinson- White Syndrome by a Closed Heart Technique,&quot; Journal Thoracic Cardiovascular Surgery 92:406-413, 1986. cited by other
Cox et al., &quot;Modification of the Maze Procedure for Atrial Flutter and Atrial Fibrillation. I. Rational and Surgical Results,&quot; The Journal of Thoracic Cardiovascular Surgery 110:473-484, 1995. cited by other
Samuels, et al., &quot;The Electrophysiologist and the Cardiac Surgeon,&quot; Advances in Cardiac Surgery, Chapter 6, vol. 12, 2000, pp. 97-115. cited by other
Schmitt, et al., &quot;Recent Advances in Cardiac Mapping Techniques,&quot; Catheter-Ablative Techniques and the Implantable Cardioverter Defibrillator, 1999, pp. 149-156. cited by other.
This application claims priority to co-owned U.S. Provisional Patent
Applications Ser. No. 60/261,343 filed Jan. 13, 2001, Ser. No. 60/263,739
filed Jan. 24, 2001, Ser. No. 60/282,029 filed Apr. 6, 2001 and Ser. No.
60/286,952 filed Apr. 26, 2001, and is a continuation of application Ser.
No. 09/879,294 filed Jun 12, 2001, now U.S. Pat. 6,447,443, the
1.  A method of performing an electrode placement procedure on a patient&#39;s heart, comprising: providing a first tissue contact device comprising: a rigid tissue contact member sized and
shaped to fit through a small incision in a region of the patient&#39;s chest;  an illumination device coupled to the rigid tissue contact member;  a maneuvering apparatus having a rigid shaft and a handle;  and a remotely actuatable joint moveably coupling
the tissue contact member to the maneuvering apparatus;  introducing the rigid contact member of the first tissue contact device to the patient&#39;s thoracic cavity through a small incision in the patient&#39;s chest;  providing illumination;  actuating the
joint remotely from outside the thoracic cavity of the patient;  maneuvering the tissue contact member of the first tissue contact device to position pericardium away from a surface of the heart to create space between the surface of the heart and the
pericardium using the first tissue contact device, the space providing exposure of the heart;  providing a second tissue contact device comprising: a rigid tissue contact member having an ablation electrode;  and a maneuvering apparatus having a shaft
and a handle coupled to the rigid contact member;  introducing the rigid contact member of the second tissue contact device into the thoracic cavity of the patient through an incision in the region of the patient&#39;s chest;  and placing the ablation
electrode on or within the exposed heart.
2.  The method of claim 1 further comprising: stimulating the heart in order to adjust the beating of the heart.
3.  The method of claim 2 wherein the heart is stimulated by pacing.
4.  The method of claim 2 wherein the heart is stimulated by defibrillation.
5.  The method of claim 1 further comprising: sensing the electrical signals of the heart.
6.  The method of claim 1 further comprising: administering at least one drug to the heart.
7.  The method of claim 6 wherein the drug is selected from the group consisting of: a beta-blocker, a cholinergic agent, a cholinesterase inhibitor, a calcium channel blocker, a sodium channel blocker, a potassium channel agent, adenosine, an
adenosine receptor agonist, an adenosine deaminase inhibitor, dipyridaniole, a monoamine oxidase inhibitor, digoxin, digitalis, lignocaine, a bradykinin agent, a serotoninergic agonist, an antiarrythmic agent, a cardiac glycoside, a local anesthetic,
8.  The method of claim 1 further comprising: delivering one or more fluids to the heart.
9.  The method of claim 8 wherein the one or more fluids comprises at least one diagnostic agent, therapeutic agent or biological agent.
10.  The method of claim 1 further comprising: evaluating the hemodynamic condition of the heart with a sensor.
11.  The method of claim 1, further comprising: providing at least one fluid adjacent the electrode.
12.  The method of claim 1 further comprising: stimulating a nerve to adjust the beating of the heart to a first condition.
13.  The method of claim 12 wherein the first condition is a stopped condition.
14.  The method of claim 12 wherein the first condition is a slowed condition.
15.  The method of claim 12 further comprising: adjusting stimulation of the nerve to adjust the beating of the heart to a second condition.
16.  The method of claim 15 further comprising: stimulating the nerve a subsequent time in order to re-adjust the beating of the heart to the first condition.
17.  The method of claim 15 wherein the stimulation is stopped to achieve the second condition.
18.  The method of claim 15 wherein the second condition is a beating condition.
19.  The method of claim 15 further comprising: stimulating the heart in order to adjust the beating of the heart to the second condition.
20.  The method of claim 19 wherein the heart is stimulated by pacing.
21.  The method of claim 12 wherein the nerve is a vagal nerve.
22.  The method of claim 1 wherein the second tissue contact device is a suction assisted device.
23.  The method of claim 1 further comprising: providing at least one fluid adjacent the second tissue contact device.
24.  The method of claim 23 wherein the fluid is provided adjacent the ablation electrode.
25.  The method of claim 1 wherein the tissue contact member of the first or second tissue contact device comprises one or more hooks.
26.  The method of claim 1 wherein the tissue contact member of the first or second tissue contact device comprises one or more clamps.
27.  The method of claim 1 wherein the tissue contact member of the first or second tissue contact device comprises one or more barbs.
28.  The method of claim 1 wherein the tissue contact member of the first or second tissue contact device comprises a magnet.
29.  The method of claim 1 wherein the joint is a pivot that allows the tissue contact member of the first tissue contact device to rotate relative to the rigid shaft.
30.  The method of claim 1 wherein the joint is a hinge.
31.  The method of claim 1 wherein the tissue contact member of the first or second tissue contact device is shaped to conform to a surface of tissue.
32.  The method of claim 1 wherein the tissue contact member of the first or second tissue contact device is shapeable to conform to a surface of tissue.
33.  The method of claim 1 wherein the illumination device includes a light source.
34.  The method of claim 1 wherein the illumination device includes an illuminating material.
35.  The method of claim 1 wherein the illumination device includes a fiber optic conduit.
36.  The method of claim 1 wherein the illumination device includes a light pipe.
37.  The method of claim 1 wherein the illumination device includes a battery.
38.  The method of claim 1 wherein the illumination device provides UV light.
39.  The method of claim 1 wherein the illumination device provides IR light.
40.  The method of claim 1 wherein the illumination device provides visible light.
41.  The method of claim 1 wherein the illumination device includes a laser.
42.  The method of claim 1 wherein the illumination device includes a switch.
43.  The method of claim 1 wherein the first tissue contact device includes a LED.
44.  The method of claim 1 wherein the first or second tissue contact device is removably coupled to a flexible hose during the procedure.
45.  The method of claim 1 wherein the first or second tissue contact device is removably coupled to a flexible tube during the procedure.
46.  The method of claim 1 wherein the first or second tissue contact device is removably coupled to a flexible catheter during the procedure.
47.  The method of claim 1 wherein the first or second tissue contact member is guided into a desired position.
48.  The method of claim 1 wherein the first or second tissue contact member comprises one or more sensors.
49.  The method of claim 1 further comprising ablating a tissue of the heart to perform at least a portion of a MAZE procedure.
50.  The method of claim 1 wherein the step of placing the ablation electrode on the heart includes placing the ablation electrode on epicardial tissue of the heart.
51.  The method of claim 1 further comprising the step of guiding the first or second tissue contact device into a desired position using a guidance technique.
52.  The method of claim 51 wherein the guidance technique is a flouroscopic guidance technique.
53.  A method of performing an electrode placement procedure on a patient&#39;s heart, comprising: providing a first tissue contact device comprising: a rigid tissue contact member sized and shaped to fit through a small incision in a region of the
patient&#39;s chest;  an illumination device coupled to the rigid tissue contact member;  a maneuvering apparatus having a rigid shaft and a handle;  and a remotely actuatable joint moveably coupling the tissue contact member to the maneuvering apparatus;
introducing the rigid contact member of the first tissue contact device to the patient&#39;s thoracic cavity through a small incision in the patient&#39;s chest;  providing illumination;  actuating the joint remotely from outside the thoracic cavity of the
patient;  maneuvering the tissue contact member of the first tissue contact device to position pericardium away from a surface of the heart to create space between the surface of the heart and the pericardium using the first tissue contact device, the
space providing exposure of the heart;  providing a second tissue contact device comprising: a rigid tissue contact member having an energy transfer electrode;  and a maneuvering apparatus having a shaft and a handle coupled to the rigid contact member;
introducing the rigid contact member of the second tissue contact device into the thoracic cavity of the patient through an incision in the region of the patient&#39;s chest;  and placing the electrode on or within the exposed heart.
54.  The method of claim 53 further comprising stimulating the heart in order to adjust the beating of the heart.
55.  The method of claim 53 wherein the heart is stimulated by pacing.
56.  The method of claim 53 wherein the heart is stimulated by defibrillation.
57.  The method of claim 53 further comprising sensing the electrical signals of the heart.
58.  The method of claim 53 further comprising administering at least one drug to the heart.
59.  The method of claim 58 wherein the drug is a beta-blocker, a cholinergic agent, a cholinesterase inhibitor, a calcium channel blocker, a sodium channel blocker, a potassium channel agent, adenosine, an adenosine receptor agonist, an
adenosine deaminase inhibitor, dipyridamole, a monoamine oxidase inhibitor, digoxin, digitalis, lignocaine, a bradykinin agent, a serotoninergic agonist, an antiarrythmic agent, a cardiac glycoside, a local anesthetic, atropine, a calcium solution, an
agent that promotes heart rate, an agent that promotes heart contractions, dopamine, a catecholamine, an inotrope glucagon, a hormone, forskolin, epinephrine, norepinephrine, thyroid hormone, a phosphodiesterase inhibitor, prostacyclin, prostaglandin or
60.  The method of claim 53 further comprising delivering one or more fluids to the heart.
61.  The method of claim 60 wherein the fluid comprises a diagnostic agent, a therapeutic agent, a biological agent, or a combination thereof.
62.  The method of claim 53 further comprising evaluating the hemodynamic condition of the heart with a sensor.
63.  The method of claim 53, further comprising providing at least one fluid adjacent the electrode.
64.  The method of claim 53 further comprising stimulating a nerve to adjust the beating of the heart to a first condition.
65.  The method of claim 64 wherein the first condition is a stopped condition.
66.  The method of claim 64 wherein the first condition is a slowed condition.
67.  The method of claim 64 further comprising adjusting stimulation of the nerve to adjust the beating of the heart to a second condition.
68.  The method of claim 67 further comprising stimulating the nerve a subsequent time in order to re-adjust the beating of the heart to the first condition.
69.  The method of claim 67 wherein the stimulation is stopped to achieve the second condition.
70.  The method of claim 67 wherein the second condition is a beating condition.
71.  The method of claim 67 further comprising stimulating the heart in order to adjust the beating of the heart to the second condition.
72.  The method of claim 71 wherein the heart is stimulated by pacing.
73.  The method of claim 64 wherein the nerve is a vagal nerve.
74.  The method of claim 53 wherein the second tissue contact device is a suction assisted device.
75.  The method of claim 53 further comprising providing at least one fluid adjacent the second tissue contact device.
76.  The method of claim 75 wherein the fluid is provided adjacent the ablation electrode.
77.  The method of claim 53 wherein the tissue contact member of the first or second tissue contact device comprises one or more hooks.
78.  The method of claim 53 wherein the tissue contact member of the first or second tissue contact device comprises one or more clamps.
79.  The method of claim 53 wherein the tissue contact member of the first or second tissue contact device comprises one or more barbs.
80.  The method of claim 53 wherein the tissue contact member of the first or second tissue contact device comprises a magnet.
81.  The method of claim 53 wherein the joint is a pivot that allows the tissue contact member of the first tissue contact device to rotate relative to the rigid shaft.
82.  The method of claim 53 wherein the joint is a hinge.
83.  The method of claim 53 wherein the tissue contact member of the first or second tissue contact device is shaped to conform to a surface of tissue.
84.  The method of claim 53 wherein the tissue contact member of the first or second tissue contact device is shapeable to conform to a surface of tissue.
85.  The method of claim 53 wherein the illumination device includes a light source.
86.  The method of claim 53 wherein the illumination device includes an illuminating material.
87.  The method of claim 53 wherein the illumination device includes a fiber optic conduit.
88.  The method of claim 53 wherein the illumination device includes a light pipe.
89.  The method of claim 53 wherein the illumination device includes a battery.
90.  The method of claim 53 wherein the illumination device provides UV light.
91.  The method of claim 53 wherein the illumination device provides IR light.
92.  The method of claim 53 wherein the illumination device provides visible light.
93.  The method of claim 53 wherein the illumination device includes a laser.
94.  The method of claim 53 wherein the illumination device includes a switch.
95.  The method of claim 53 wherein the first tissue contact device includes a LED.
96.  The method of claim 53 wherein the first or second tissue contact device is removably coupled to a flexible hose during the procedure.
97.  The method of claim 53 wherein the first or second tissue contact device is removably coupled to a flexible tube during the procedure.
98.  The method of claim 53 wherein the first or second tissue contact device is removably coupled to a flexible catheter during the procedure.
99.  The method of claim 53 wherein the first or second tissue contact member is guided into a desired position.
100.  The method of claim 53 wherein the first or second tissue contact member comprises one or more sensors.
101.  The method of claim 100 further comprising ablating a tissue of the heart to perform at least a portion of a MAZE procedure.
102.  The method of claim 53 wherein the step of placing the electrode on the heart includes placing the electrode on epicardial tissue of the heart.
103.  The method of claim 53 further comprising the step of guiding the first or second tissue contact device into a desired position using a guidance technique.
104.  The method of claim 103 wherein the guidance technique comprises flouroscopy.  Description
This invention relates generally to a system and method for positioning an organ, and more particularly to a system capable of positioning, manipulating, stabilizing and/or holding a heart during cardiac surgery.  This invention also relates to a
positioning system and method that includes monitoring one or more chemical, physical or physiological characteristics of a bodily tissue or fluid during a medical procedure.
conduit to bypass the coronary obstruction and, thereby provide blood flow to the downstream ischemic heart tissues.  The procedure is generally lengthy, traumatic and subject to patient risk.  Among the risk factors involved is the use of a
cardiopulmonary bypass (CPB) circuit, also known as a &quot;heart-lung machine&quot;, to both pump blood and oxygenate the blood so that the patient&#39;s heart may be stopped during the surgery, with its function performed by the CPB circuit.
comprises two stitches to one side of the apex of the graft and the artery, a stitch through the apex and two stitches placed at the opposite side of the apex.  Again, suture loops are drawn up and the suture pulled straight through to eliminate
The proximal anastomosis of a saphenous vein graft to the aorta, i.e., an aortosaphenous vein anastomosis, is formed by first removing the pericardial layer that covers the aorta.  An occluding or side-biting clamp may be placed on the aorta at
heel portion of the graft and an additional five or six are necessary to complete the toe of the graft.  Finished proximal anastomoses typically have a &quot;cobra-head&quot; appearance.
It is essential for the surgeon to take steps to minimize the possibility of thrombosis, narrowing and/or premature closure of the anastomosis due to technical errors.  Some surgeons feel the proximal anastomosis must have a take-off angle of 45
degrees while other surgeons believe the take-off angle is not critical.  In addition, it was felt that intima-to-intima contact of the vessels at the anastomosis was critical for endothelization to occur, thereby making an ideal union of the vessels.
However, most surgeons now feel intima-to-adventitia contact is acceptable.  The main objective of the surgeon is to create an anastomosis with an expected long-term patency rate of greater than 5 to 10 years.  The creation of an anastomosis currently
One essential requirement for creating an anastomosis without error is adequate exposure of the target vessel.  Acute visualization of the vessel walls is mandatory in order to properly place each stitch and avoid inadvertently including the back
wall of the vessel in a stitch, which in effect narrows or completely occludes the vessel.  In order to achieve the required exposure most surgeons will employee blood-less field devices such as shunts, snares, and misted blowers.  Further, largely
applied at the weld site to enhance light absorption and minimize thermal damage to the surrounding tissue.  Using a dye that adsorbs light at a very specific frequency, a laser can be then used to selectively heat the dye and not the surrounding tissue. Photosensitive dyes used in laser welding procedures may or may not bind chemically to the tissue&#39;s proteins.  Unlike sutures or staples, laser welding may offer a water tight seal to hold bodily fluids in, thereby preventing blood loss, infections and
One component intra-luminal mechanical anastomotic devices are generally stent-like in design.  The graft and the target vessel, i.e., the aorta or coronary artery, are forced into tubular shapes by the device.  In general, the application of
both the graft and the target vessel may also occur during delivery of the device.  Extra sealing methods, e.g., tissue sealants, may be necessary to provide a leak-free anastomosis.  In addition, the size of the device is strongly related to the size of
the vessels.  Therefore, a range of devices and measurement of the vessels is necessary.
One component extra-luminal mechanical anastomotic devices generally require a delivery tool to position the coupling device in the recipient vessel.  One component extra-luminal mechanical coupling devices generally allow direct intima-to-intima
for two reasons: 1) solid grabbing of the vessel wall is necessary to evert an artery, thus one tip of the pair of pincers will roughly touch the intima; and, 2) eversion causes high strain (stretching), which will damage the arteries.  Another problem
is that skills are still necessary for proper eversion.  The surgeon has to estimate where to grab the vessel wall and how to lift it over one of the pins to obtain a symmetrical anastomosis.  A specially designed mounting tool may make the step of
mounting the graft onto the coupling device easier and may help to minimize damage to the graft.  In addition, care must be taken to avoid compression of tissue by the coupling device since compression can cause pressure necrosis.
One area which may create difficulties for the patient and extra expense and time for a stopped heart CABG procedure involves CPB.  In a CPB procedure all the patient&#39;s blood, which normally returns to the right atrium, is diverted to a system
which supplies oxygen to the blood and removes carbon dioxide from the blood and returns the blood, at sufficient pressure, into the patient&#39;s aorta for further distribution into the body.  Generally such a system requires several separate components,
Suction stabilization systems, such as the Medtronic Octopus.RTM.  Tissue Stabilizer and Accessories (available from Medtronic, Inc., Minneapolis, Minn.  USA), the current model being designated the &quot;Octopus 3.TM.  stabilization system&quot;, use
6,015,378, and co-assigned U.S.  patent applications Ser.  No. 09/396,047, filed Sep. 15, 1999, Ser.  No. 09/559,785, filed Apr.  27, 2000, and Ser.  No. 09/678,203, filed Oct.  2, 2000; and European Patent Publication No. EP 0 993 806.  The Octopus.TM.
It would be desirable to have an organ positioning system and method that comprises a device that engages organ tissue and allows a surgeon to easily position, manipulate, stabilize and/or hold an organ during a controlled intermittent asystole
It would further be desirable to have an organ positioning system and method that comprises a device that engages organ tissue and allows a surgeon to easily position, manipulate, stabilize and/or hold organ tissue during a medical procedure,
thereby providing adequate exposure, e.g., adequate visualization and/or access, to a surgical site.
It would further be desirable to have an organ positioning system and method which is capable of positioning, manipulating, stabilizing and/or holding an organ and/or tissue while controllably monitoring one or more chemical, physical or
physiological characteristics of a bodily tissue or fluid during a medical procedure.
One aspect of the present invention provides a system for positioning, manipulating, holding, grasping, immobilizing and/or stabilizing an organ, such as a heart.  The system may include one or more tissue-engaging devices, one or more suction
system may comprise a tissue-engaging head, a support apparatus and a clamping mechanism for attaching the tissue-engaging device to a stable object, such as a retractor that is fixed to a patient&#39;s chest.  A tissue-engaging device of the system may
comprise one or more energy transfer elements connected to an energy source, one or more sensors connected to a processor, one or more suction openings connected to a suction source, and/or one or more fluid openings connected to a fluid source.
a medical procedure.  The medical procedure may include deployment of one or more anastomotic devices, e.g., during a CABG procedure.  The medical procedure may include intermittently stimulating a vagal nerve and pacing a heart.  The medical procedure
may include ablating one or more tissues of a heart.  The medical procedure may include placement of a lead on or within a heart.  The method may include the use of suction to engage and position an organ, such as a heart.
FIG. 1 shows a schematic view of one embodiment of system 10 for positioning, manipulating, holding, grasping, immobilizing and/or stabilizing tissue in accordance with the present invention.  In this embodiment, system 10 is shown to comprise
tissue-engaging device 20, a suction source 30, a fluid source 40, an energy source 50, a sensor 60 and a processor 70.  System 10 may also include an indifferent electrode, a drug delivery device and/or an illumination device (all not shown in FIG. 1).
The indifferent electrode may be placed on the patient&#39;s body such as the back, thigh or shoulder or another site other than the suction site.  The drug delivery device may be used to deliver drugs to a patient.  The illumination device may be used to
illuminate a surgical site.
As shown in FIG. 2, in one embodiment of the present invention, tissue-engaging device 20 may comprise a tissue-engaging head 221, a support apparatus 222 and a clamping mechanism 223 for attaching device 20 to a stable structure, such as a
retractor (not shown in FIG. 2), that is fixed to a patient.  Tissue-engaging device 20 may also comprise one or more energy transfer elements, one or more connectors for connecting the one or more energy transfer elements to energy source 50, one or
more sensing elements, one or more connectors for connecting the one or more sensing elements to sensor 60, one or more suction openings, one or more conduits for providing suction from suction source 30 to the one or more suction openings, one or more
fluid openings, one or more conduits for providing fluid from fluid source 40 to the one or more fluid openings, and/or one or more connectors for connecting one or more components of tissue-engaging device 20 to processor 70.
Tissue-engaging device 20 and its components are preferably made of one or more biocompatible materials.  Biocompatible materials or biomaterials are usually designed and constructed to be placed in or onto tissue of a patient&#39;s body or to
hydroxapatite, epoxies, human or animal protein or tissue such as bone, skin, teeth, collagen, laminin, elastin or fibrin, organic materials such as wood, cellulose, or compressed carbon, and other materials such as glass, and the like.  Materials that
Tissue-engaging device 20 may comprise a tissue-engaging head.  The tissue-engaging head may be flexible thereby allowing the head to conform to the surface of target tissue.  The tissue-engaging head may be malleable thereby allowing a surgeon
to shape the head to conform to the surface of target tissue.  The tissue-engaging head may be rigid having a shape conforming to the surface of target tissue.  The tissue-engaging head may comprise a tissue contact surface.  The tissue contact surface
of the tissue-engaging head may be shaped or is shapeable to conform to the surface of the target tissue.
In one embodiment of the present invention, the tissue-engaging head of device 20 is formed of medical grade silicone rubber or thermoplastic elastomeric material (e.g., polyurethane).  Preferably, the material selected in this embodiment has a
low durometer (e.g., about 50) so that the tissue-engaging head may conform to the surface of the heart.  The material selected may be a substantially transparent or translucent material.  Further contemplated are embodiments in which the tissue-engaging
head is made of multiple materials of different durometers and properties, to form, for example, an endoskeleton or exoskeleton to provide varying degrees of stiffness and flexibility along different portions of the tissue-engaging head.
In one embodiment of the present invention, the tissue-engaging head may comprise one or more mechanical means for engaging and/or grasping tissue.  For example, the tissue-engaging head may comprise one or more hooks, clamps, screws, barbs,
sutures, straps, tethers and/or staples.  The tissue-engaging head may comprise a cuff or basket-type device designed to fit completely or partially around an organ, e.g., a heart.  The tissue-engaging head may comprise one or more chemical means for
engaging and/or grasping tissue.  For example, the tissue-engaging head may comprise tissue glue or adhesive.  The tissue-engaging head may comprise one or more coupling means for engaging and/or grasping tissue.  For example, a suction means in addition
to a mechanical means may be used to engage or grasp tissue.  A magnetic means may also be used to engage or grasp tissue.
In one embodiment of the present invention, the tissue-engaging head 221, as shown in FIG. 3, may comprise a plurality of legs that may flex to conform to the surface of the heart.  The legs of the tissue-engaging head may be arranged in
starfish-shaped configuration.  Preferably in this embodiment, there are 2-4 legs and, most preferably, there are 3 legs.  The legs may be generally arcuate, curving downwardly away from the attached ends of the legs to the free ends of the legs.  The
legs may be sufficiently flexible that they may bend to conform to flat or curved surfaces, facilitating use of the tissue-engaging head at the apex or elsewhere on the heart.
In use, the legs may allow the tissue-engaging head to be oriented to avoid placement over particular features of the heart anatomy, such as the cardiac arteries, or to avoid conflict with other surgical devices, such as a heart stabilizer of the
type sold under the trade designation &quot;OCTOPUS&quot; by Medtronic, Inc., Minneapolis, Minn., USA.
In one embodiment of the present invention, the tissue-engaging head of device 20 may be sufficiently resiliently flexible that it may flex to allow it to be pushed through a small incision, cannula or port.  Once inside the chest cavity, the
flexible head will return to its original shape.  For example, the legs may be configured and sufficiently flexible that they can be drawn against one another to a collapsed position for entering into a thoracic cavity through a small incision, cannula
or port in endoscopic and/or closed chest surgery.  In addition, to closed chest surgery, this invention is applicable to open chest/split sternum surgery, in particular open chest, beating heart surgery for repositioning the heart to improve access to
various coronary arteries.
One or more suction ports, openings, orifices, channels and/or elements 424 may be provided along a tissue contact surface or tissue-engaging face of suction head 221 in fluid communication with the legs to apply suction between the legs and the
surface of the heart to grasp the surface (see FIGS. 4 and 5).  One or more suction ports, openings, orifices, channels and/or elements may be positioned in or on each leg.
As shown in FIGS. 4 and 5, one or more tissue-engaging members or standoffs 425 may be provided within the tissue-engaging head to prevent vacuum channels from being closed off as tissue and the suction head are drawn together to allow continued
fluid communication along the vacuum channels.  In addition, one or more tissue-engaging members may be provided adjacent the orifice of a vacuum passageway to prevent the orifice and tissue being drawn together to close the orifice, thereby maintaining
fluid communication between the vacuum passageway and the vacuum channels.
FIGS. 6 and 7 illustrate one embodiment of a tissue-engaging suction head 221 in which a resiliently flexible flange 426 (also shown in FIG. 4) resiliently deforms against heart tissue 603 to form a seal to help maintain the vacuum in vacuum
channel 424.  The standoff or tissue-engaging member 425 limits how far suction head 221 may be pulled down toward the surface of the heart to maintain vacuum channel 424, as illustrated in FIG. 7.  tissue-engaging members may be elongated having a
direction of elongation extending generally radially with respect to an orifice.
The end of each flange may be beveled as illustrated in FIG. 4 so that the laterally outward edge of each end extends further than the laterally inward edge of each end.  Flange 426 may extend along substantially the entire periphery of suction
head 221, see FIG. 5, so that vacuum can be maintained in the area defined between flange 426, the body of suction head 221 and the surface of the heart.
Tissue-engaging head of device 20, may comprise one or more bumps 427, for example, located on the inner surface of resiliently flexible peripheral flange 426, see FIG. 4.  Most preferably, bumps 427 are generally hemispherical convex structures
forming an integral part of the inner surface of the peripheral flange 426.  When suction is pulled through vacuum channel 424, bumps 427 are pulled against the surface of an organ as flange 426 deforms against the surface of the organ, e.g., the
epicardium of the heart.  Bumps 427 help retain suction head 221 in place on the heart.  Bumps 427 may be arranged in an alternating pattern, aligned pattern or irregular pattern, for example.
Textures other than bumps are also contemplated, such as dimples, spikes, ridges, grooves (e.g., microgrooves), roughened texture (e.g., micro-textured), surface grain, strips, ribs, channels, ruts, embedding or adhering abrasive particles in or
on the surface, gluing or laminating the texture onto the surface, or other surface treatments, conditions or configurations that increase the grip of the inner surface of the tissue-engaging head on the epicardium.  It is also contemplated that the
other underside surfaces of the tissue-engaging head may be textured to increase surface area and/or gripping.  For example, a texture is preferably provided on the tissue-engaging members or standoffs 425, and this texture may be in the same form as the
texture on the inner surface of the peripheral flange 426 or a different gripping texture.  The texture may be formed by any suitable methods, such as by molding, chemical etching, roughening with sandpaper or other abrasives (e.g., sand blasting),
electrical means (such as EDM machining), thermal means, or laser etching, for example.
FIG. 2 illustrates one embodiment of the tissue-engaging head 221 in which tube fitting 224 includes a ninety degree bend.  Other tube fittings having other angles of bend are also contemplated.  The tube fitting 224 receives a vacuum line (not
shown in FIG. 2).  Tissue-engaging head 221 and tube fitting 224 may be free to rotate relative to the end of support arm 222.  FIG. 2 also illustrates yet one embodiment of tissue-engaging head 221 in which a filter element 225 is provided within the
tube fitting 224.  The filter element 225 preferably includes a through bore.
The tissue-engaging device 20 may include one or more fluid openings for delivery and/or removal of one or more fluids.  Tissue-engaging device 20 may include needles for injection of fluids, drugs and/or cells into organ tissue.  As shown in
FIGS. 8, 9 and 10, tissue-engaging device 20 may comprise catheter or cannula 810 for blood removal or delivery into an organ, e.g., a heart.  In the case of the heart, the cannula or catheter may be placed through the wall of the heart and into an
interior chamber of the heart comprising blood, for example, into the left ventricle.  Blood may be removed or delivered via a blood pump.  For example, tube fitting 811, which is in fluid communication with catheter or cannula 810, may be attached to a
CPB circuit or a cardiac assist circuit such as an LVAD circuit.  Tissue-engaging device 20 may include one or more openings for delivery or removal of one or more gases including smoke evacuation.
As mentioned earlier and as shown in FIG. 11, one or more tissue-engaging members or standoffs 425 may be provided within the tissue-engaging head to prevent vacuum channels from being closed off as tissue and the suction head are drawn together
to allow continued fluid communication along the vacuum channels.  Alternatively or in addition to standoffs, a porous screen, mesh and/or fabric 450 (as shown in FIG. 12) may be used to prevent the orifice and tissue being drawn together to close the
orifice, thereby maintaining fluid communication between the vacuum passageway and the vacuum channels.  The screen, mesh and/or fabric may engage or contact tissue.  The screen, mesh and/or fabric may be placed on top of standoffs.  The screen, mesh
and/or fabric may comprise a number of materials including metallic, ceramic and/or polymeric materials.  The screen, mesh and/or fabric may be made of a synthetic or natural material.  In one embodiment of the present invention, the mesh may be made of
a medical grade Dacron material.  As shown in FIG. 13, the screen, mesh and/or fabric may comprise bumps 451.  Alternatively or in addition to standoffs, a porous foam 452 (as shown in FIG. 14), e.g., a polymeric foam, or other porous material or
materials may be used to prevent the orifice and tissue being drawn together to close the orifice, thereby maintaining fluid communication between the vacuum passageway and the vacuum channels.
The tissue-engaging head may be made of one or more biodegradable materials, thereby allowing the head to be absorbed by the patient over time.
Tissue-engaging device 20 may comprise a maneuvering or support apparatus or means such as a shaft, a handle or an arm 222, as shown in FIGS. 2 and 8, connected to the tissue-engaging head to position the head to thereby position or hold tissue
such as the heart.  The support shaft, handle or arm may be rigid, flexible, telescoping or articulating.  The shaft, handle or arm may comprise one or more hinges or joints for maneuvering and placing device 20 against tissue.  The hinges or joints of
the maneuvering or support apparatus may be actuated remotely, for example with pull wires, from outside a patient&#39;s body.  The shaft, handle or arm may be malleable or shapeable.  The maneuvering or support means may be made of a shape memory alloy
wherein heat may be use to change the shape of the maneuvering or supporting means.
The support shaft, handle or arm may be of the type that can readily be changed between a flexible or articulating condition and a rigid condition.  For example, a support arm may comprise a plurality of rigid members that are free to articulate
relative to one another until a central cable pulls the rigid members together to lock the support arm in a rigid condition.  The cable is controlled, for example, by a handle that rotates to pull tension on the cable, thereby drawing the rigid members
together to lock them into position.  Each rigid member has opposite ends, one of which is concave and the other of which is convex (e.g., hemispherical).  The convex end of one rigid member fits into the concave end of the adjacent rigid member, and
allows the member to articulate relative to the adjacent member if the central cable has not been tensioned to lock the rigid members together.  Most preferably, the rigid members are not of uniform cross section, with the rigid members closer to the
distal end having a smaller cross section than the rigid members closer to the proximal end.  A suitable articulating mechanism could be similar to the type used in the &quot;OCTOPUS 3&quot;.TM.  tissue stabilization system sold by Medtronic, Inc., Minneapolis,
Minn.  USA.  See, also, the articulating arm mechanisms disclosed in U.S.  Pat.  Nos.  5,836,311; 5,927,284 and 6,015,378, co-assigned U.S.  patent application Ser.  No. 09/396,047, filed Sep. 15, 1999; and Ser.  No. 09/678,203, filed Oct.  2, 2000, and
European Patent Publication No. EP 0 993 806.
The tissue-engaging head of suction device 20 may be rigidly, permanently, moveably, or removeably coupled, connected or mounted onto the maneuvering or support apparatus or means.  For example, the head may be coupled via a hinge or joint to an
articulating support arm.  The head may be coupled, for example, to the maneuvering or support apparatus via one or more springs, hinges, joints and/or bellows.  The tissue-engaging head may be designed to be detachable or replaceable; for example, the
head may snap on and/or off the maneuvering or support apparatus.  Magnets, glues, screws and/or bolts may also be used to attach the tissue-engaging head to the maneuvering or support apparatus.  Also contemplated is use of sets of tissue-engaging heads
of different sizes and/or shapes.
The mechanism connecting the tissue-engaging head to the support arm may permit the head to rotate and/or pivot on one or more axes relative to the support arm.  For example, the tissue-engaging head may be permitted to rotate relative to the
support arm along a first axis, and the tissue-engaging head may be allowed to pivot relative to the support arm along a second axis generally perpendicular to the first axis.  The tissue-engaging head may be allowed to pivot and/or rotate along one or
more axes even after the support arm is locked into a rigid condition.
The mechanism connecting the tissue-engaging head to the support arm may comprise one or more resiliently-flexible suspension elements.  The tissue-engaging head and suspension element may be integrally molded of the same material.  As used
herein, &quot;integral&quot; or &quot;integrally molded&quot; refer to constructions in which one continuous piece is formed, rather than separate pieces that are connected together (e.g., mechanically or by welding or adhesive).  The suspension element may comprise a
bellows type structure that resiliently flexes to allow the tissue-engaging head to move in response to beating of the heart.  The suspension element may be expandable to allow the tissue-engaging head to stretch or move toward and away from the support
arm in response to the beating heart.  The suspension element may allow movement including rotational and twisting motions in one or more directions.
In one embodiment of the present invention, the suspension element comprises a bellows 226 (as shown in FIGS. 2 and 3) that flexes as the suspension element is stretched.  As the bellows is stretched, the effective spring rate of the suspension
element increases.  A suction and/or fluid passageway, conduit or lumen may extend through the bellows-type suspension element 226 (as shown in FIG. 4).  The bellows may provide the further advantage of keeping the one or more passageways, conduits or
lumens open through normal stretching of the bellows.  In an alternate embodiment, the suspension element comprises a two-stage or multi-stage bellows providing a varying spring rate between stages, as well as a high spring rate when the bellows is
Tissue-engaging device 20 may be fixed in position relative to a patient.  For example, the maneuvering or support apparatus of device 20 may be designed to attach to or lock onto one or more stable objects such as an operating table, a
retractor, an endoscopic port and/or a support arm of another tissue-engaging apparatus.  A retractor may be, for example, a sternal retractor or a rib retractor.  An endoscopic port may be, for example, a cannula, such as a trocar cannula placed in a
patient&#39;s chest.  A portion of a patient&#39;s skeletal system may also be considered a stable object.  FIG. 15 shows tissue-engaging device 20 locked onto a sternal retractor 150 fixed to a patient&#39;s chest.  In FIG. 15, tissue-engaging device 20 is shown
supporting a patient&#39;s heart while it is engaged or attached to the apex of the patient&#39;s heart.  The patient&#39;s heart may be beating or stopped.  FIG. 16 shows another embodiment of the present invention wherein support arm 162 of a first tissue-engaging
device 160 is attached or coupled via clamp 167 to support arm 164 of a second tissue-engaging device 163.  Clamp 167 may be designed to couple or attach onto a variety of stable objects including the support arms of various tissue-engaging devices.  The
second tissue-engaging device 163 is shown in FIG. 16 clamped onto a retractor 150 that is fixed to a patient&#39;s chest via clamp 165.  Retractor 150 is shown in FIG. 16 to comprise suture holders 168.  In FIG. 16, the first tissue-engaging device 160 is
shown supporting a patient&#39;s heart while head 161 of device 160 is engaged or attached to the apex of the heart; the second tissue-engaging device 163 is shown stabilizing or immobilizing an area of the heart while head 166 of device 163 is engaged or
attached to the surface of the heart.  In this embodiment of the present invention, the patient&#39;s heart may be beating or stopped.
The maneuvering or support apparatus may comprise one or more lumens or conduits for communicating suction and/or delivering and/or removing fluids and/or gases to the tissue-engaging head.  The one or more conduits or lumens may be connected to
at least one suction opening and/or fluid opening located on tissue-engaging device 20.
In one embodiment of the present invention, the maneuvering or support apparatus may be a suture, strap or tether.  For example, the tissue-engaging head of device 20 may be attached to one or more sutures, straps or tethers which may be affixed
or attached to a stable object such as a retractor.  For example, FIG. 17 illustrates a tissue-engaging device 170 comprising a suction head 221 and a vacuum tube 171, which provides vacuum to suction head 221 and provides a tether or means for
manipulating and holding suction head 221 to position and orient the heart.  FIG. 18 illustrates a tissue-engaging device 180 comprising a suction head 221, vacuum tube 171, and suture, line or strap 181 that provides a tether or means for manipulating
and holding suction head 221 to position and orient the heart.  The suture, line or strap may be retained in a suture guide, clamp or lock 168, for example, on a sternal retractor (as shown in FIG. 16), although it is also contemplated that it could be
retained on a rib retractor, port, cannula or other device or mechanism, or mounted on the patient, operating table or other stable or stationary object.
The tissue-engaging head may comprise one or more energy transfer elements positioned on, along, within or adjacent a tissue contact surface.  Energy transfer elements transfer energy to target tissue.  For example, energy transfer elements may
be conductive elements that may supply RF energy, microwave energy or ultrasound energy to target tissue.  Energy transfer elements may be, for example, laser elements for supplying laser light to target tissue or they may be cryo elements.  Two or more
energy transfer elements or conductive elements of tissue-engaging device 20 may be arranged in a biopolar arrangement wherein at least one element is used as a positive electrode and at least one element is used as a negative electrode.  One or more
energy transfer elements or conductive elements of tissue-engaging device 20 may be arranged in a monopolar arrangement wherein at least one element is used as one electrode and an indifferent electrode is placed elsewhere on the patient&#39;s body such as
the back, thigh or shoulder or another site other than the tissue-engaging device 20 site.
As shown in FIGS. 19 and 20, tissue-engaging head 221 may comprise one or more energy transfer elements or electrodes 190.  Electrodes 190 may be connected to energy source 50 (not shown in FIGS. 19 and 20) via electrically conductive wires or
leads 191.  One or more electrodes 190 may be positioned on one or more standoffs 425.  For example, FIG. 20 shows two electrodes 190 each positioned on a different standoff 425.  FIG. 21 shows six electrodes 190 positioned in pairs on three different
standoffs 425.  In another embodiment of the present invention, tissue-engaging head 221 may comprise lead 191 coupled to a perimeter electrode 190 positioned on or along flange 426 as demonstrated in FIGS. 22 and 23.  In another embodiment of the
present invention, tissue-engaging head 221 may comprise lead 191 coupled to a conductive screen or mesh electrode 190 as shown in FIGS. 24 and 25.  For example, the conductive screen or mesh may be made of a metallic material or a conductive polymeric
material or combinations thereof.  In addition, electrode 190 may or may not be positioned on standoffs.
Tissue-engaging device 20 may comprise one or more switches, e.g., a surgeon-controlled switch.  One or more switches may be incorporated in or on tissue-engaging device 20 or any other location easily and quickly accessed by the surgeon for
regulation of tissue-engaging device 20 by the surgeon.  A switch may be, for example, a hand switch, a foot switch, or a voice-activated switch comprising voice-recognition technologies.  A switch may be physically wired to device 20 or it may be a
Tissue-engaging device 20 may be slaved to suction source 30, fluid source 40, energy source 50, sensor 60 and/or processor 70.  For example, tissue-engaging device 20 may be designed to automatically stop engaging tissue when processor 70 sends
a signal to stop tissue engagement.  Tissue-engaging device 20 may include a visual and/or audible signal used to alert a surgeon to any change in tissue engagement and/or a visual and/or audible signal may be included in system 10.  For example, a
Tissue-engaging device 20 may be positioned and used, for example, through a thoracotomy, through a sternotomy, percutaneously, transvenously, arthroscopically, endoscopically, for example, through a percutaneous port, through a stab wound or
puncture, through a small incision, for example, in the chest, in the groin, in the abdomen, in the neck or in the knee, or in combinations thereof.  Tissue-engaging device 20 may be guided into a desired position using various guidance techniques, e.g.,
flouroscopic guidance techniques.
System 10 may include suction source 30 for providing suction to tissue-engaging device 20.  As shown in FIG. 26, tissue-engaging device 20 may be attached to a flexible or rigid hose or tubing 900 for supplying suction and/or fluids from a
suitable suction source and/or fluid source to the target tissue surface through suction and/or fluid elements, openings, orifices, or ports of device 20.  Tubing 900 may comprise one or more stopcocks 901 and/or connectors 902 such as luer connectors.
Suction may be provided to device 20 by the standard suction available in the operating room.  Suction source 30 may be coupled to tissue-engaging device 20 with a buffer flask 903 and/or filter 904 as shown in FIG. 27.  Suction may be provided at a
negative pressure of between 200-600 mm Hg with 400 mm Hg preferred.  As used herein, the terms &quot;vacuum&quot; or &quot;suction&quot; refer to negative pressure relative to atmospheric or environmental air pressure in the operating room.
Alternatively, suction may be provided via one or more manual or electric pumps, syringes, suction or squeeze bulbs or other suction or vacuum producing means, devices or systems.  Suction source 30 and/or tubing 900 may comprise one or more
vacuum regulators, resistors, stopcocks, connectors, valves, e.g., vacuum releasing valves, filters, conduits, lines, tubes and/or hoses.  The conduits, lines, tubes, or hoses may be flexible or rigid.  For example, a flexible suction line may be used to
communicate suction to device 20, thereby allowing device 20 to be easily manipulated by a surgeon.  Another method that would allow the surgeon to easily manipulate device 20 includes incorporation of suction source 30 into device 20.  For example, a
small battery operated vacuum pump or squeeze bulb may be incorporated into device 20.
Suction source 30 may be slaved to tissue-engaging device 20, fluid source 40, energy source 50, sensor 60 and/or processor 70.  For example, suction source 30 may be designed to automatically stop suction when processor 70 sends a signal to stop
suction.  Suction source 30 may include a visual and/or audible signal used to alert a surgeon to any change in suction.  For example, a beeping tone or flashing light may be used to alert the surgeon when suction is present.  Suction source 30 may be
slaved to a robotic system or a robotic system may be slaved to suction source 30.  Suction may be used to secure, anchor or fix tissue-engaging device 20 to an area of tissue.  The area of tissue may comprise a beating heart or a stopped heart.  Suction
may be used to remove or aspirate fluids from the target tissue site.  Fluids removed may include, for example, blood, saline, Ringer&#39;s solution, ionic fluids, contrast fluids, irrigating fluids and energy-conducting fluids.  Steam, vapor, smoke, gases
and chemicals may also be removed via suction.
System 10 may include fluid source 40 for providing fluids to tissue-engaging device 20.  Tissue-engaging device 20 may be attached to a flexible or rigid hose or tubing for supplying fluids from fluid source 40 to the target tissue through fluid
elements, openings, orifices, or ports of device 20.  Fluid source 40 may be any suitable source of fluid.  Fluid source 40 may include a manual or electric pump, an infusion pump, a peristaltic pump, a roller pump, a centrifugal pump, a syringe pump, a
syringe, or squeeze bulb or other fluid moving means, device or system.  For example, a pump may be connected to a shared power source or it may have its own source of power.  Fluid source 40 may be powered by AC current, DC current, or it may be battery
powered either by a disposable or re-chargeable battery.  Fluid source 40 may comprise one or more fluid regulators, e.g., to control flow rate, valves, fluid reservoirs, resistors, filters, conduits, lines, tubes and/or hoses.  The conduits, lines,
tubes, or hoses may be flexible or rigid.  For example, a flexible line may be connected to device 20 to deliver fluid and/or remove fluid, thereby allowing device 20 to be easily manipulated by a surgeon.  Fluid reservoirs may include an IV bag or
bottle, for example.
Fluid source 40 may be incorporated into tissue-engaging device 20, thereby delivering fluid or removing fluid at the target tissue site.  Fluid source 40 may be slaved to tissue-engaging device 20, suction source 30, energy source 50, sensor 60
and/or processor 70.  For example, fluid source 40 may be designed to automatically stop or start the delivery of fluid while tissue-engaging device 20 is engaged with tissue.  Fluid source 40 may be slaved to a robotic system or a robotic system may be
slaved to fluid source 40.
Fluid source 40 may comprise one or more switches, e.g., a surgeon-controlled switch.  One or more switches may be incorporated in or on fluid source 40 or any other location easily and quickly accessed by the surgeon for regulation of fluid
delivery by the surgeon.  A switch may be, for example, a hand switch, a foot switch, or a voice-activated switch comprising voice-recognition technologies.  A switch may be physically wired to fluid source 40 or it may be a remote control switch.  Fluid
source 40 and/or system 10 may include a visual and/or audible signal used to alert a surgeon to any change in the delivery of fluid.  For example, a beeping tone or flashing light may be used to alert the surgeon that a change has occurred in the
Fluids delivered to tissue-engaging device 20 may include saline, e.g., normal, hypotonic or hypertonic saline, Ringer&#39;s solution, ionic, contrast, blood, and/or energy-conducting liquids.  An ionic fluid may electrically tissue-engaging device
20 to tissue thereby lowering the impedance at the target tissue site.  An ionic irrigating fluid may create a larger effective electrode surface.  An irrigating fluid may cool the surface of tissue thereby preventing over heating or cooking of tissue
which can cause popping, desiccation, and charring of tissue.  A hypotonic irrigating fluid may be used to electrically insulate a region of tissue.  Fluids delivered to tissue-engaging device 20 may include gases, adhesive agents and/or release agents.
antiviral agent, a viral agent or component, a genetic agent, a ligand and a dye (which acts as a biological ligand) may be delivered with a fluid.  Biological agents may be found in nature (naturally occurring) or may be chemically synthesized.  Cells
and cell components, e.g., mammalian and/or bacterial cells, may be delivered with a fluid.
tissue-engaging device 20.  For example, a drug delivery device may be placed in contact with the inside surface of a patient&#39;s heart while tissue-engaging device 20 is placed or used on the outside surface of the patient&#39;s heart.
The drug delivery device may be slaved to tissue-engaging device 20, suction source 30, fluid source 40, energy source 50, sensor 60 and/or processor 70.  For example, a drug delivery device may be designed to automatically stop or start the
delivery of drugs during tissue engagement of tissue-engaging device 20.  The drug delivery device may be slaved to a robotic system or a robotic system may be slaved to the drug delivery device.
remote control switch.  The drug delivery device and/or system 10 may include a visual and/or audible signal used to alert a surgeon to any change in the delivery of drugs.  For example, a beeping tone or flashing light that increases in frequency as the
rate of drug delivery increases may be used to alert the surgeon.
deactivation of suction source 20 with the delivery of energy.
Energy source 50 may incorporate a controller or processor.  For example, the controller may process sensed information from a sensor.  The controller may store and/or process such information before, during and/or after a medical procedure.  For
example, the patient&#39;s tissue temperature may be sensed, stored and processed prior to and during a medical procedure.
Energy source 50 may be used to control the energy supplied to one or more energy transfer elements of tissue-engaging device 20.  Energy source 50 may also gather and process information from one or more sensors.  This information may be used to
adjust energy levels and times.  Energy source 50 may incorporate one or more switches to facilitate regulation of the various system components by the surgeon.  One example of such a switch is a foot pedal.  A switch may also be, for example, a hand
switch, or a voice-activated switch comprising voice-recognition technologies.  A switch may be physically wired to energy source 50 or it may be a remote control switch.  A switch may be incorporated in or on one of the surgeon&#39;s instruments, such as
surgical site retractor, e.g., a sternal or rib retractor, tissue-engaging device 20, or any other location easily and quickly accessed by the surgeon.  Energy source 50 may also include a display.  Energy source 50 may also include other means of
indicating the status of various components to the surgeon such as a numerical display, gauges, a monitor display or audio feedback.
Energy source 50 may incorporate a cardiac stimulator and/or cardiac monitor.  For example, electrodes used to stimulate or monitor the heart may be incorporated into tissue-engaging device 20.  Energy source 50 may comprise a surgeon-controlled
switch for cardiac stimulation or monitoring, as discussed earlier.  Cardiac stimulation may comprise cardiac pacing and/or cardiac defibrillation.  Energy source 50 may incorporate a cardiac mapping device for mapping the electrical signals of the
A visual and/or audible signal used to alert a surgeon to the completion or resumption of energy delivery, suction, sensing, monitoring, stimulation and/or delivery of fluids, drugs and/or cells may be incorporated into energy source 50.  For
the knee, or in combinations thereof.
Sensor 60 may comprise one or more switches, e.g., a surgeon-controlled switch.  One or more switches may be incorporated in or on a sensor device or any other location easily and quickly accessed by the surgeon for regulation of sensor 60 by the
surgeon.  A switch may be, for example, a hand switch, a foot switch, or a voice-activated switch comprising voice-recognition technologies.  A switch may be physically wired to sensor 60 or it may be a remote control switch.
Sensor 60 may include a visual and/or audible signal used to alert a surgeon to any change in the measured parameter, for example, tissue temperature, cardiac hemodynamics or ischemia.  A beeping tone or flashing light may be used to alert the
Sensor 60 may comprise one or more temperature-sensitive elements, such as a thermocouple, to allow a surgeon to monitor temperature changes of a patient&#39;s tissue.  Alternatively, sensor 60 may sense and/or monitor voltage, amperage, wattage
position.  Alternatively, sensor 60 may be any suitable blood gas sensor for measuring the concentration or saturation of a gas in the blood or tissues.  For example, sensor 60 may be a sensor for measuring the concentration or saturation of oxygen or
carbon dioxide in the blood or tissues.  Alternatively, sensor 60 may be any suitable sensor for measuring blood pressure or flow, for example a Doppler ultrasound sensor system, or a sensor for measuring hematocrit (HCT) levels.
Alternatively sensor 60 may be a biosensor, for example, comprising an immobilized biocatalyst, enzyme, immunoglobulin, bacterial, mammalian or plant tissue, cell and/or subcellular fraction of a cell.  For example, the tip of a biosensor may
Sensor 60 may be based on potentiometric technology or fiber optic technology.  For example, the sensor may comprise a potentiometric or fiber optic transducer.  An optical sensor may be based on either an absorbance or fluorescence measurement
Sensor 60 may be used to detect naturally detectable properties representative of one or more characteristics, e.g., chemical, physical, mechanical, thermal, electrical or physiological, of system 10 and/or a patient&#39;s bodily tissues or fluids.
For example, naturally detectable properties of patient&#39;s bodily tissues or fluids may include pH, fluid flow, electrical current, impedance, temperature, pressure, tension, components of metabolic processes, chemical concentrations, for example, the
absence or presence of specific peptides, proteins, enzymes, gases, ions, etc. Naturally detectable properties of system 10 may include, for example, pressure, tension, stretch, fluid flow, electrical, mechanical, chemical and/or thermal.  For example,
sensor 60 may be used to sense, monitor and/or control suction or vacuum delivered from suction source 30.  Sensor 60 may be used to measure suction between device 20 and tissue.  Sensor 60 may be used to sense, monitor and/or control fluid delivered
from fluid source 40.  Sensor 60 may be used to sense, monitor and/or control energy delivered from energy source 50.
Sensor 60 may include one or more imaging systems, camera systems operating in UV, visible, or IR range; electrical sensors; voltage sensors; current sensors; piezoelectric sensors; electromagnetic interference (EMI) sensors; photographic plates,
Sensor 60 may be incorporated into tissue-engaging device 20 or sensor 60 may be placed or used at a location differing from the location of tissue-engaging device 20.  For example, sensor 60 may be placed in contact with the inside surface of a
patient&#39;s heart while tissue-engaging device 20 is placed or used on the outside surface of the patient&#39;s heart.
predetermined sensor value, e.g., a particular suction value.
Sensor 60 may include a visual and/or audible signal used to alert a surgeon to any change in the one or more characteristics the sensor is sensing and/or monitoring.  For example, a beeping tone or flashing light that increases in frequency as
20 from fluid source 40 and/or the energy delivered to device 20 from energy source 50.  Alternatively, the control of suction source 30, fluid source 40 and/or energy source 50 based on output from processor 70 may be manual.
Processor 70 may include a visual display or monitor, such as, for example, a LCD or CRT monitor, to display various amounts and types of information.  By software control, the user may choose to display the information in a number of ways.  The
displaying a virtual representation of tissue-engaging device 20 on the monitor.
Alternatively, the monitor may display the voltage corresponding to the signal emitted from sensor 60.  This signal corresponds in turn to the intensity of a sensed parameter at the target tissue site.  Therefore a voltage level of 2 would
indicate that the tissue was, for example, hotter than when the voltage level was 1.  In this example, a user would monitor the voltage level and, if it exceeded a certain value, would turn off or adjust the energy source 50.
The display of processor 70 may alternatively be located on tissue-engaging device 20, suction source 30, fluid source 40, energy source 50 and/or sensor 60.  An indicator, such as an LED light, may be permanently or removeably incorporated into
tissue-engaging device 20, suction source 30, fluid source 40, energy source 50 and/or sensor 60.  The indicator may receive a signal from sensor 60 indicating that the tissue had reached an appropriate value, for example temperature.  In response, the
indicator may turn on, change color, grow brighter or change in any suitable manner to indicate that the flow of energy from energy source 50 should be modified or halted.  The indicator may also be located on tissue-engaging device 20, suction source
30, fluid source 40, energy source 50, sensor 60 and/or may be located on another location visible to the user.
Alternatively, the processor 70 may include an audio device that indicates to the user that the delivery of suction, fluids and/or energy should be halted or adjusted.  Such an audio device may be, for example, a speaker that broadcasts a sound
(for example, a beep) that increases in intensity, frequency or tone as a parameter sensed by sensor 60 increases.  The user may adjust, for example, turn down or turn off energy source 50 when the sound emitted reaches a given volume or level.  In
another embodiment, the audio device may also give an audible signal (such as the message &quot;turn off energy source&quot;), for example, when a parameter sensed by sensor 60 reaches a certain level.  Such an audio device may be located on tissue-engaging device
20, suction source 30, fluid source 40, energy source 50 and/or sensor 60.  The audio device may also be a separate device.
Processor 70 may comprise one or more switches, e.g., a surgeon-controlled switch.  One or more switches may be incorporated in or on processor 70 or any other location easily and quickly accessed by the surgeon for regulation of processor 70 by
the surgeon.  A switch may be, for example, a hand switch, a foot switch, or a voice-activated switch comprising voice-recognition technologies.  A switch may be physically wired to processor 70 or it may be a remote control switch.
In one embodiment of the present invention, system 10 may include an illumination device (not shown).  The illumination device may comprise one or more light sources and/or illuminating materials, e.g., glow-in-the-dark materials.  For example,
the tissue-engaging head of device 20 may comprise one or more glow-in-the-dark materials.  The illumination device may be based on fluorescence technologies.  The illumination device may comprise fiber optic technologies; for example a fiber optic
conduit may deliver light from a remote light source to an area adjacent tissue-engaging device 20 for illumination of a surgical site.
The illumination device may comprise a light pipe, for example, to illuminate the tissue-engaging head of device 20 and/or the surgical field adjacent device 20.  A transparent, semi-transparent or translucent tissue-engaging head may be
illuminated merely by placement of the end of a light pipe or other light source adjacent the tissue-engaging head of device 20.
The illumination source may be powered by AC current, DC current, or it may be battery powered either by a disposable or re-chargeable battery.  The illumination source may provide UV, IR and/or visible light.  The illumination source may be a
laser.  The illumination device may be incorporated into tissue-engaging device 20 or it may be incorporated into a separate device.  A separate illumination device may be positioned and used, for example, through a thoracotomy, through a sternotomy,
in combinations thereof.
The illumination device may comprise one or more switches, e.g., a surgeon-controlled switch.  One or more switches may be incorporated in or on the illumination device or any other location easily and quickly accessed by the surgeon for
regulation of the illumination device by the surgeon.  A switch may be, for example, a hand switch, a foot switch, or a voice-activated switch comprising voice-recognition technologies.  A switch may be physically wired to the illumination device or it
may be a remote control switch.
Tissue-engaging device 20, suction source 30, fluid source 40, energy source 50, sensor 60, processor 70, drug delivery device and/or illumination device may be slaved to a robotic system or a robotic system may be slaved to tissue-engaging
robotic systems may include head-mounted displays which integrate 3-D visualization of surgical anatomy and related diagnostic and monitoring data, miniature high resolution 2-D and 3-D digital cameras, a computer, a high power light source and a
standard video monitor.
thoracotomy approach.  The medical procedure may include the use of various robotic or imaging systems.  The medical procedure may be surgery on the heart.  Alternatively, the medical procedure may be surgery performed on another organ of the body.
The term &quot;medical procedure&quot; may mean any one or more medical or surgical procedures such as, for example cardiac surgery, performed with or without cardiopulmonary bypass (CPB) circuits, heart valve repair, heart valve replacement, MAZE
procedures, transmyocardial revascularization (TMR), CABG procedures, anastomosis procedures, non-surgical procedures, endoscopic procedures, non-invasive procedures, invasive procedures, port-access procedures, fluoroscopic procedures, beating heart
surgery, vascular surgery, neurosurgery, electrophysiology procedures, diagnostic and therapeutic procedures, ablation procedures, ablation of arrhythmias, endovascular procedures, treatment of one or more organs and/or vessels, treatment of the heart,
aneurysm repair, aortic aneurysm repairs, imaging procedures of the heart and great vessels, CAT scan procedures, MRI procedures, cardiograms, pharmacological therapies, drug delivery procedures, delivery of biological agents, gene therapies, cellular
therapies, cancer therapies, radiation therapies, genetic, cellular, tissue and/or organ manipulation or transplantation procedures, coronary angioplasty procedures, placement or delivery of coated or noncoated stents, LVAD procedures, lead placement
procedures, placement of cardiac reinforcement devices, placement of cardiac assistance devices, atherectomy procedures, atherosclerotic plaque manipulation and/or removal procedures, emergency procedures, cosmetic procedures, reconstructive surgical
procedures, biopsy procedures, autopsy procedures, surgical training procedures, birthing procedures, congenital repair procedures, and medical procedures that require positioning one or more organs and/or tissues.
In one embodiment of the present invention, as shown in FIG. 28, system 10 includes multiple tissue-engaging devices 20 each comprising a tissue-engaging head 221, an articulating support arm 222 and a mounting clamp 223.  Both devices 20 are
coupled to a suction source 30 that provides a negative pressure of about 400 mm Hg.  In this embodiment, suction source 30 is shown coupled to processor 70.  In this embodiment, both tissue-engaging devices 20 are clamped to retractor 150 that is fixed
to a patient&#39;s chest.  The head of the first device 20 is placed on the apex or left ventricle of the patient&#39;s heart.  Suction is provided to the first tissue-engaging device via tubing 900.  The head of the first device 20 is allowed to firmly engage
or grasp the surface of the heart.  The heart is positioned into the desired orientation.  For example, the heart may be positioned for providing access to lateral and/or posterior vessels of the heart.  Articulating arm 222 of the first device 20 is
locked into position when the heart is in the desired orientation via knob 950 thereby positioning and supporting the heart.  In this embodiment, the head of the second device 20 is placed on the surface of the patient&#39;s heart adjacent a coronary artery. Suction is provided to the second tissue-engaging device via tubing 900.  The head of the second device 20 is allowed to firmly engage or grasp the surface of the heart.  Articulating arm 222 of the second device 20 is locked into position via knob 951
thereby immobilizing the area of tissue adjacent the head of the second device 20.
As shown in FIG. 28, tissue-engaging head of first device 20 may comprise one or more electrodes connected via leads 191 to energy source 50.  In this embodiment, energy source 50 is shown coupled to processor 70.  The electrodes may be used for
pacing and/or defibrillation of the patient&#39;s heart.  Tissue-engaging head of first device 20 may also comprise one or more sensors for sensing the patient&#39;s ECG, for example, connected to processor 70 via conductor 952.  Second device 20 may comprise
one or more fluid openings for delivery of fluid from fluid source 40.  Fluid source 40 is coupled to second device 20 via tubing 953.  In this embodiment, fluid source 40 is shown coupled to processor 70.  As shown in this embodiment of the present
invention, processor 70 is coupled to a manual foot switch 954.  In addition, processor 70 comprises multiple displays 955 and knobs 956 for providing feedback and control.
As shown in FIG. 28, endotracheal tube 957 comprising one or more electrodes may be positioned in a patient&#39;s trachea.  Endotracheal tube 957 may be connected to a breathing regulator (not shown in FIG. 28).  The electrodes of endotracheal tube
957 may be used to stimulate the patient&#39;s vagal nerve thereby slowing or stopping the patient&#39;s heart.  The patient may be given drugs as described above to help stop the beating of the heart and/or to prevent &quot;escape&quot; beats.  Following vagal
stimulation, the heart may be paced via first device 20.  The electrodes of endotracheal tube 957 may be coupled to processor 70 and energy source 50 via leads 191.
In one embodiment of the present invention, a nerve stimulator may be used to electrically manipulate cardiac rhythm by stimulating the vagus nerve.  This vagal stimulation may produce asystole (slowing or stopping of the heart&#39;s beating.) Once
this induced asystole is stopped, i.e. once the vagal stimulation is stopped, the heart may be allowed to return to its usual cardiac rhythm.  Alternatively, the heart may be paced, thereby maintaining a normal cardiac output.  Vagal stimulation, alone
or in combination with electrical pacing, may be used selectively and intermittently to allow a surgeon to perform a medical procedure, such as a CABG procedure, and yet still allow the heart itself to supply blood circulation to the body while one or
more tissue-engaging devices 20 are used to position and/or stabilize an area of the heart.  For example, stimulation of the vagus nerve in order to temporarily and intermittently slow or stop the heart is described in U.S.  Pat.  No. 6,006,134 entitled
&quot;Method and Device for Electronically Controlling the Beating of a Heart Using Venous Electrical Stimulation of Nerve Fibers&quot;, Dec.  21, 1999, to Hill and Junkman and in U.S.  patent application Ser.  No. 09/670,441 filed Sep. 26, 2000, Ser.  No.
09/669,960 filed Sep. 26, 2000, Ser.  No. 09/670,370 filed Sep. 26, 2000, Ser.  No. 09/669,961 filed Sep. 26, 2000, Ser.  No. 09/669,355 filed Sep. 26, 2000 and Ser.  No. 09/670,369 filed Sep. 26, 2000.  These patents and patent applications are assigned
to Medtronic, Inc.  and are incorporated herein by reference.
FIG. 29 shows a flow diagram of one embodiment of the present invention.  The patient is prepared for a medical procedure at 700.  Once the patient is prepared, the heart is engaged and positioned using tissue-engaging device 20 of system 10
(Block 705).  Once the heart is positioned in a desired orientation, a nerve that controls the beating of the heart is stimulated to slow down or stop the contractions of the heart (Block 708).  Such a nerve may be for example a vagal nerve.  During this
time, one or more of a variety of pharmacological agents or drugs may be delivered to the patient.  These drugs may produce reversible asystole of a heart while maintaining the ability of the heart to be electrically paced.  Other drugs may be
administered for a variety of functions and purposes as described above.  Drugs may be administered at the beginning of the procedure, intermittently during the procedure, continuously during the procedure or following the procedure.
the body.  Following initial slowing or stopping of the heart, a medical procedure, e.g., CABG, ablation, lead placement and/or other procedure as described above, is begun (Block 710).  Following a brief interval of nerve stimulation while a medical
procedure is performed, nerve stimulation is ceased (Block 713) and the heart is allowed to contract.  A cardiac stimulator or pacemaker may be used to cause the heart to contract or the heart may be free to beat on its own (Blocks 722 and 724).  In one
embodiment of the present invention, tissue-engaging device 20 includes one or more electrodes, which may be used for pacing, coupled to energy source 50.  Processor 70 may control both cardiac and nerve stimulation.  For example, processor 70 may
automatically proceed to block 713 to cease nerve stimulation.  In addition, processor 70 may automatically begin cardiac stimulation.  If the medical procedure needs to continue or a new medical procedure is to be performed, the heart may be
repositioned if necessary or desired at Block 748.
FIG. 30 shows a flow diagram of one embodiment of the present invention.  The patient is prepared for a medical procedure at 700.  At this point, the heart may be engaged and positioned by tissue-engaging device 20 of system 10, for example, to
provide access to the posterior or backside of the heart (Block 705).  As seen in FIG. 29, heart positioning may occur throughout the entire procedure in a continuous or intermittent manner.  At Block 710, a medical procedure, e.g., a CABG procedure
comprising the use of a distal anastomotic device or other medical procedure as mentioned above, is begun.  At Block 717, it is determined if the heart needs to be repositioned.  For example, upon completion of a first anastomosis, e.g., via delivery of
a distal anastomotic device, the heart may be repositioned to provide better access for creation of a second anastomosis.  Again at Block 725, it is determined if the heart needs to be repositioned.  For example, upon completion of a second anastomosis,
e.g., via delivery of a distal anastomotic device, the heart may again be repositioned to provide access for creation of a third anastomosis.  During the medical procedure fluids may be delivered to tissue-engaging device 20 from fluid source 40.
Processor 70 may control the delivery of fluids from fluid source 40.
FIG. 31 shows a flow diagram of one embodiment of the present invention.  The patient is prepared for a medical procedure at 700.  At this point, the heart may be engaged and positioned by tissue-engaging device 20 of system 10, for example, to
provide access to the posterior or backside of the heart (Block 705).  As seen in FIG. 29, heart positioning may occur throughout the entire procedure in a continuous or intermittent manner.  At Block 706, the patient&#39;s hemodynamic condition may be
sensed and monitored, for example, the patient&#39;s ECG may be sensed and monitored by sensor 60 and processor 70.  At Block 707, it is determined if the heart needs to be repositioned.  Following repositioning of the heart (Block 723), if necessary, a
medical procedure is performed at Block 710.  The medical procedure, e.g., a CABG procedure comprising the use of a distal anastomotic device or other medical procedure as mentioned above, is begun.  At Block 711, it is again determined if the heart
needs to be repositioned.  For example, upon completion of a first anastomosis, e.g., via delivery of a distal anastomotic device, the heart may be repositioned to provide better access for creation of a second anastomosis located in a different location
from the first anastomosis.  Following repositioning of the heart (Block 723), if necessary, the medical procedure is continued at Block 720.
System 10 may be used for creating space in a surgical field.  For example, tissue-engaging device 20 may be used to grasp and position the pericardium away from the surface of the heart thereby creating space between the surface of the heart and
the pericardium.  This type of procedure may be termed &quot;tenting&quot;.  Tissue-engaging device 20 may be used to grasp and position a heart away from a rib cage, for example in an endoscopic procedure, thereby creating space for a surgeon to work between the
heart and the rib cage.  Tissue-engaging device 20 may be used to grasp and position a heart away from other adjacent or nearby organs thereby creating space for a surgeon to work.
In one embodiment of the present invention, as shown in FIG. 32, the medical procedure may include the use of one or more tissue stabilization devices, e.g., the &quot;OCTOPUS 3&quot;.TM.  which is marketed by Medtronic, Inc., Minneapolis, Minn.  USA.
See, also, tissue stabilizers disclosed in U.S.  Pat.  Nos.  5,836,311; 5,927,284 and 6,015,378, co-assigned U.S.  patent application Ser.  No. 09/396,047, filed Sep. 15, 1999; and Ser.  No. 09/678,203, filed Oct.  2, 2000, and European Patent
Publication No. EP 0 993 806.  These patents are assigned to Medtronic, Inc.  and are incorporated herein by reference.  As shown in FIG. 32, tissue-engaging device 20 of system 10 may be used in a medical procedure, e.g., a CABG procedure, in
combination with a tissue stabilizer 990.  As shown in FIG. 32, both devices may be attached to retractor 150 fixed to a patient&#39;s chest.
In one method of the present invention, as shown in FIG. 33, the medical procedure may include the use of one or more tissue ablation devices.  For example, see tissue ablation devices disclosed in U.S.  patent application Ser.  No. 09/844,220
filed Apr.  26, 2001, now U.S.  Pat.  No. 6,584,320, Ser.  No. 09/844,221 filed Apr.  26, 2001 and Ser.  No. 09/843,897 filed Apr.  26, 2001, now U.S.  Pat.  No. 6,558,382.  These patent applications are assigned to Medtronic, Inc.  and are incorporated
herein by reference.  As shown in FIG. 33, tissue-engaging device 20 of system 10 may be used in a medical procedure, e.g., an ablation procedure, in combination with a tissue ablation device 995.  Device 20 may be attached to retractor 150 fixed to a
patient&#39;s chest.  Tissue ablation devices may be used to ablate tissue located within a body cavity, such as the endocardial or epicardial tissue of the heart.  Other body organ tissue, such as the liver, lungs or kidney, may also be positioned and
ablated.  Other tissue types may be ablated including skin, muscle or even cancerous tissue or abnormal tissue growth.
Method and system for organ positioning and stabilization, Keogh, et al., James R. Keogh, Scott E Jahns, Michael A. Colson, Gary W. Guenst, Christopher Olig, Paul A. Pignato, Karen Montpetit, Thomas Daigle, Douglas H. Gubbin, William G. O'Neill, Katherine Jolly, Application number 10 156-315, Surgery, beating heart, Patent Application, local area, Surgical instrument, Medtronic, Patent Search, Patent Attorney, tree browser, Atrial Fibrillation, Blood coagulation test
This invention relates generally to a system and method for positioning an organ, and more particularly to a system capable of positioning, manipulating, stabilizing and/or holding a heart during cardiac surgery. This invention also relates to apositioning system and method that includes monitoring one or more chemical, physical or physiological characteristics of a bodily tissue or fluid during a medical procedure.BACKGROUND OF THE INVENTIONCoronary artery disease remains the leading cause of morbidity and mortality in Western societies. Coronary artery disease is manifested in a number of ways. For example, disease of the coronary arteries can lead to insufficient blood flow tovarious areas of the heart. This can lead to the discomfort of angina and the risk of ischemia. In severe cases, acute blockage of coronary blood flow can result in irreversible damage to the myocardial tissue including myocardial infarction and therisk of death.A number of approaches have been developed for treating coronary artery disease. In less severe cases, it is often sufficient to merely treat the symptoms, with pharmaceuticals, or treat the underlying causes of the disease, with lifestylemodification. In more severe cases, the coronary blockage can be treated endovascularly or percutaneously using techniques such as balloon angioplasty, atherectomy, laser ablation, stents, and the like.In cases where these approaches have failed or are likely to fail, it is often necessary to perform a coronary artery bypass graft (CABG) procedure. CABG surgery, also known as "heart bypass" surgery, generally entails the use of a graft orconduit to bypass the coronary obstruction and, thereby provide blood flow to the downstream ischemic heart tissues. The procedure is generally lengthy, traumatic and subject to patient risk. Among the risk factors involved is the use of acardiopulmonary bypass (CPB) circuit, also known as a "heart-lung machine", to both pump blood and oxygenate the blood