HK1016052B - Apparatus for temporarily immobilizing a local area of tissue - Google Patents

Description

Device for temporarily fixing a local area of tissue

Technical Field

The present invention relates generally to surgical procedures on human tissues and organs. More particularly, the present invention relates to a method and apparatus for temporarily immobilizing a region of tissue motion, such as the heart wall, to permit surgery to be performed on that local region of tissue.

Background

Coronary artery disease has been a leading cause of morbidity and mortality in western society. Coronary artery disease can manifest itself in a number of ways. For example, coronary artery disease can result in insufficient blood flow to various regions of the heart. This may lead to symptoms such as angina pectoris and myocardial ischemia. In severe cases, severe blockage of arterial blood flow can result in the risk of unrecoverable damage to myocardial tissue, including myocardial infarction and death.

Various approaches to the treatment of coronary artery disease have been developed. In less severe cases, various symptoms are often treated by means of pharmaceutical agents or by changing lifestyle to treat the underlying cause. In more severe cases, coronary obstructions may be treated with, for example, balloon angioplasty (balloon angioplasty), atherectomy, laser ablation, stents (stents), and the like.

When these approaches fail or are likely to fail, it is often necessary to perform a coronary bypass graft. The procedure generally comprises the steps of: first, direct access to the heart is achieved. This is usually done by opening the chest cavity through a central sternotomy and spreading the left and right ribs apart; and the pericardial sac was opened to gain direct access to the heart.

One or more of the blood vessels used for the grafting procedure are then removed from the patient. This is usually accompanied by moving a mammary artery or a saphenous vein, but other graft vessels may be used.

Next, a cardiopulmonary bypass operation is performed. This typically requires arterial and venous cannulation to communicate blood flow to a cardiopulmonary machine, to bring body temperature down to 32 degrees celsius, cross-clamping of the aorta (cross-clamping), and cardioplegic perfusion of the coronary arteries to arrest cardiac activity and cool the heart to 4 degrees celsius. The heart is often required to stop beating or beating because the uninterrupted pumping motion caused by the beating of the heart will make it very difficult or even impossible to perform heart surgery in certain areas.

Once the heart stops beating, a graft can be connected to the relevant portion of a coronary artery (or arteries) and then disconnected from the cardiopulmonary bypass, allowing the heart to re-beat and the cannula removed. Finally the chest was closed.

Cardiopulmonary bypass is cumbersome to the patient and is particularly costly and time consuming to perform. In cardiopulmonary bypass, all of the blood normally returned to the right atrium of the patient is diverted to a system that provides oxygen to the blood and removes carbon dioxide, and then returns the blood to the patient's aorta with sufficient pressure for distribution to various parts of the body. Typically, such a system requires several separate components, including an oxygenator, several pumps, a container, a blood temperature control system, filters, and flow, pressure, and temperature sensors.

A problem during cardiopulmonary bypass is that the responder blood has a non-endothelial surface, i.e., a surface distinct from a blood vessel. In particular, blood exposure to the external surface can actually lead to humoral and cellular responses that activate all inflammatory responses and some slower specific immune responses. Other complex problems from cardiopulmonary bypass include: loss of red blood cells and platelets due to damage from shear stress. In addition, cardiopulmonary bypass requires the use of an anticoagulant, such as heparin. This increases the risk of bleeding. Finally, cardiopulmonary bypass sometimes requires additional transfusions to the patient. If from a blood supply source other than the patient, the additional blood may expose the patient to various diseases originating from the blood.

Because of the risks that can occur during cardiopulmonary bypass, others have attempted to perform coronary artery graft bypass surgery without cardioplegia and cardiopulmonary bypass. For example, "placement of coronary artery bypass graft without oxygenation Pump", published by Trapp and Bisarya at Annals Thorac. surg. Vol.19, pp.1 (1/1975) pages 1-9, is described herein as incorporating sufficient muscle by a sufficiently deep circular suture to place a region of the heart in suspension and prevent damage to the coronary arteries. Still more recently, Fanning et al, in Annals thorac. surg. vol.55 (2.1993) pages 486-9, have described "retrofittable coronary artery bypass grafting without cardiopulmonary bypass" also fixing the area of the bypass graft by means of stabilizing sutures.

While these approaches have met with some success, they often require the surgeon to have enhanced skill to properly fit, since even with sutures, the beating heart moves more than necessary continuously within the area of interest.

Summary of The Invention

It is therefore an object of the present invention to provide a method and apparatus for temporarily immobilizing a local area of tissue, such as a region of a beating heart, without the aid of stable sutures.

It is another object of the present invention to provide a method and apparatus for facilitating coronary artery bypass graft surgery on a beating heart.

It is a further object of the present invention to provide a method and apparatus for performing a coronary bypass graft that does not require the heart to stop beating, nor does the patient need to be connected to a cardiopulmonary bypass machine.

These and other objects are achieved by the present invention, which comprises a method and apparatus for temporarily immobilizing a localized region of tissue. In particular, the present invention provides a method and apparatus for temporarily immobilizing a local region of cardiac tissue that allows surgery to be performed on coronary vessels in the region without significantly degrading the pumping function of the beating heart. This local region of cardiac tissue is fixed to an extent sufficient to perform minimally invasive or microsurgical procedures within this region of the heart. The invention is characterized by a suction device that enables a fixation. The suction device is connected to a source of negative pressure. The suction device has a series of suction ports on one surface. The suction through the device maintains a certain suction effect at each suction opening. The device is shaped to conform to the surface of the heart. Thus, when the device is placed on the surface of the heart and suction is generated, it can be brought into engagement with the surface of the heart by means of the suction effect of the suction openings. The suction device is also fixed to a fixed object, such as an operating table or a sternum or rib retractor. Therefore, the heart region near the suction device can be temporarily fixed or stabilized with respect to the fixed object while maintaining the suction state. In such a manner, the coronary arteries can be immobilized even while the heart itself is still beating, thereby allowing a shunt graft to be attached to the coronary arteries. Furthermore, the suction device can be used in a conventional, open chest situation, or in a minimally invasive situation, such as endoscopy.

Brief description of the drawings

The foregoing and other aspects of the invention are best understood from the following detailed description of the invention when read in conjunction with the accompanying drawings. In the drawings:

FIG. 1 is a plan view of an apparatus for temporarily immobilizing a local area of cardiac tissue in contact with the heart by performing a small thoracotomy.

Fig. 2a and 2b show a first type of suction device used in fig. 1.

Fig. 3a and 3b show a second type of suction device used in fig. 1.

Fig. 4 is a longitudinal sectional view of a suction plate used in the present invention.

Fig. 5 is a cross-sectional view of a suction plate used in the present invention, taken along line 5-5 of fig. 4.

Fig. 6 is a longitudinal sectional view of a suction arm used in the present invention.

Fig. 7 is a plan view of a suction arm used in the present invention.

FIG. 8 is a detailed block diagram of a pair of expanded suction devices deployed on a heart.

Fig. 9 and 10 show the effect of the spread-apart motion (spread-apart motion) shown in fig. 8.

Fig. 11 is an example of motion in a plane parallel to the surface of the heart at a point on the heart tissue during the 1/2 breathing cycle when the heart is unconstrained, and also shows the motion at the same point on the heart tissue when using the suction devices.

Figure 12 is an enlarged view of figure 11 showing the movement of the same point on the heart tissue when using the suction devices.

Fig. 13 is another embodiment of the present invention.

FIG. 14 is a plan view of an apparatus for temporarily immobilizing a local area of heart tissue in contact with the heart through a median sternotomy procedure.

FIG. 15 is a side view of another embodiment of the present invention placed against the surface of the heart.

Fig. 16 is a bottom view of another embodiment of the device of the present invention shown in fig. 15.

FIG. 17 is a side view of yet another embodiment of the present invention placed against the surface of the heart.

Fig. 18 is a bottom view of yet another embodiment of the present invention.

Figure 19 is a cross-sectional view of a human body showing another method of accessing the surface of the heart, particularly using a less invasive trocar.

Fig. 20A is a cross-sectional view of a human body showing another embodiment of the present invention, particularly another embodiment of the fastening device.

Fig. 20B is a top view of the embodiment shown in fig. 20A.

Fig. 21 is a perspective view of a fastening device.

Fig. 22 shows a top view of the fastening device.

Figure 23 is a side view of another embodiment of a suction device.

Figure 24 is a further embodiment of a suction device.

FIG. 25 is a perspective view of another embodiment of a fixation device.

Fig. 26A is a bottom view of another embodiment of a suction plate for use in the fixture.

Fig. 26B is a perspective view of yet another embodiment of a suction plate for use in the fixture.

FIG. 27 is a perspective view of a rotating handle used to bend or orient the suction plate portion of the fixture.

Fig. 28 is a bottom view of another embodiment of a fixation device.

Fig. 29 is a plan view of a stretcher used in another embodiment of the invention.

Fig. 30 shows another embodiment of the stretcher.

Fig. 31 shows a further embodiment of the fastening device, in particular of the fastening device for fastening each suction plate to the operating table rail.

Figure 32 is a cross-sectional view of the arm shown in figure 31.

Fig. 33 shows a further embodiment of the invention, in particular a suction device substantially similar to that shown in fig. 13, but with the suction openings at the top of the suction plate.

The figures are not drawn to scale.

Detailed description of the preferred embodiments

Fig. 1 is a view of a fixation device 11 for temporarily fixing a region of cardiac tissue. In the preferred embodiment, the surgeon accesses a localized area of the heart through a small thoracotomy, preferably in the fourth or fifth intercostal space. An incision 10 of approximately 10 cm is made in the thorax between the two ribs (see dashed lines). The costal cartilage may be temporarily removed and the ribs around the incision may be spread apart slightly using a retractor (not shown) to provide adequate surgical access to the mammary arteries and heart. As shown, a pair of suction devices 12, 13 are inserted. The first suction device 12 is inserted through a small puncture wound 8 located approximately 10 cm below the incision 10 between the two ribs. The stab wound may be made in any acceptable manner. Once this surgery is completed, the stab wound may be used for thoracic drainage after closing the upper thoracic cavity. As described below in connection with FIG. 19, the suction device has a hood 180 made of latex rubber that fits over the tip as it penetrates the chest wall to prevent blood and tissue from entering the suction port and blocking the suction opening. After introduction of the suction device, the hood 180 is removed and the tip is positioned on the heart. The second suction device 13 is introduced through the incision 10 onto the surface of the heart. As shown, the tip of each suction device is finally placed in a certain local area of the heart tissue to be fixed, i.e. on each side of the coronary artery on which a graft will be made.

As shown, the suction devices 12, 13 are fastened to a stationary object, such as a surgical table 16, by fastening means 14, 15, respectively. Of course, other objects besides surgical tables may be used as fixation objects, including a floor, a ceiling, and even a part of the patient, such as the patient's skeletal system, e.g., the sternum. In this embodiment, each fastening device 14, 15 is a variable friction arm model 244, available from Manfrotto Nord, Inc. of Zona Industrial di Villapaiera, Feltre BL I-32032, Italy. Each fastening device 14, 15 has a series of toggles 17 which can be locked in position. Thus, the fastening means can lock the suction device in any desired position within the three-dimensional space. Although not shown, each fastening device (or each suction device or two suction devices) may also be connected to each other, so that a truss-type structure may be formed, thereby improving the overall rigidity of the fixing device 11.

The suction devices 12, 13 are connected to a suction source 114 via lines 20, 21. The suction source 114 is preferably a standard suction source of the type available in operating rooms and can be connected to the devices by means of two-liter buffer bottles (not shown) for each device. The suction pressure provided is a negative pressure of 200-600 mm Hg, preferably 400 mm Hg. As shown, each suction device basically has two parts, a suction plate 22 and an arm 23. Fig. 2 and 3 show the specific structure of the suction devices 12 and 13, respectively.

Referring now to fig. 2a and 2b, fig. 2a is a side view of a suction device 12 showing the suction device placed against the contours of the heart. As shown, the end of the suction device comprises a suction plate 22 and an arm 23 connected by a continuous hinge or neck 71. The suction plate 22 has a substantially planar surface which substantially conforms to the curvature of the heart 1 shown here in outline. In the preferred embodiment, the suction arm 23 is connected to the suction plate 22 so that the suction plate 22 can be rotated or bent to obtain a desired orientation with respect to the arm 23. This is done by the neck 71. The neck 71 is designed to be relatively bendable, that is, it can be bent by hand to a desired orientation, while the suction plate 22 and the arm 23 are rigid. In the preferred embodiment, the suction plate 22 and the suction arm 23 are both made of stainless steel 316, while the neck 71 is made of stainless steel 321. Of course, rather than the neck 71 being able to be adapted by hand as desired, other means may be provided to enable the suction plate 22 to move or rotate relative to the arm 23, such as locking hinges, as are well known in the art, and a remotely actuated joint. See, for example, U.S. patent No.5,374,277 to Hassler, the contents of which are incorporated herein by reference. It is believed that a remotely actuated hinge is particularly advantageous for a suction device used for endoscopic purposes. As shown, the arm 23 has a suction lumen 30 therethrough which communicates with the suction conduit 31 in the suction plate 22 via a neck lumen 72. The suction duct 31 in the suction plate 22 also leads through a suction aperture 32 (best seen in fig. 2 b) to a suction opening 33.

Fig. 2b is a bottom view of the suction device 12. As shown, in the preferred embodiment, four aligned suction ports 33 are used, although the specific or particular number and location may vary. Each suction port 33 has a suction hole 32, and each suction hole is preferably located at a position offset from the center of the suction port 33. The suction holes 32 are offset from the center of the suction port 33 so that if a large upwelling (possibly in the form of a blister or bell curve) of tissue occurs as a result of suction, the tissue does not immediately block suction by blocking the suction holes 32, but if the suction holes are centered in the suction port 33, the tissue immediately blocks suction by blocking the suction holes 32. Furthermore, the diameter of the suction holes 32 is much smaller than the diameter of the suction port 33, so that a relatively high resistance path is formed between the suction port 33 and the suction catheter 31, which results in a loss of sealing between the tissue and the suction port in one suction port (and thus in a loss of fixation of the suction port to the tissue) and also in a sharp pressure drop in the remaining suction ports. In the preferred embodiment, the diameter of the suction hole 32 is 2mm, and the diameter of the suction opening is 6 mm. As can be seen by comparing fig. 2A and 2B, the relatively straight side suction openings define a substantially flat surface across the end of each suction opening.

Referring now to fig. 3a and 3b, fig. 3a is a side view of the suction device 13 shown in fig. 1. As shown, the end of the suction device 13 includes a suction plate 22 and an arm 23 connected by a continuous hinge or neck 71. The suction plate 22 has a substantially flat surface that substantially conforms to the curvature of the heart 1. In the preferred embodiment, the suction arm 23 is connected to the suction plate 22 so that the suction plate 22 can be rotated or bent in any of three axes to achieve a desired orientation with respect to the arm. This is done by the neck 71. The neck 71 is substantially similar to that shown in figure 2a, except that the suction device 13 has a suction plate 22 angled with respect to the suction arm 23. In the preferred embodiment, the suction plate 22 of the suction device 13 is perpendicular to the suction arm 23, but other angular orientations are possible.

Fig. 3b is a bottom view of the suction device 13. As shown, in the preferred embodiment, the suction plate 22 of the suction device 13 is substantially similar to that shown in fig. 2 b. In the preferred embodiment, the diameter of the suction hole 32 is 2mm, and the diameter of the suction port 33 is 6 mm.

Fig. 4 is a longitudinal sectional view of the suction plate 22 used in the fixing device 11. As shown, the suction plate 22 has a series of suction ports 33, each of which is connected to a suction duct 31 through a suction hole 32. Each suction opening 33 has a substantially flat cylindrical side. Of course, other configurations may be used, such as a tapered suction port, a dome-shaped suction port, and so forth. As can be seen from this figure, the bottom or day end of each suction opening itself defines a generally flat surface across each suction opening end along the bottom surface of the suction plate. Furthermore, although the suction openings are shown as being interconnected or may define a continuous surface, it is also possible to arrange the suction openings such that: i.e. they are independent of each other and different from each other, but it is still possible that the door defines a flat surface along the bottom surface of the suction plate, along their ends.

Fig. 5 is a sectional view of the suction plate 22 taken along line 5-5 in fig. 4. As shown, the suction port 33 is connected to the suction duct 31 through the suction hole 32. The top of the suction plate 22 has a beveled or inclined surface 36. With this type of surface, the area 37 can be better accessed for surgery.

Fig. 6 is a longitudinal sectional view of the suction arm 23. The end 71 of the suction arm 23 has a neck 71 (not shown in this view) secured thereto. As shown, a suction chamber 30 is provided through the arm 23, said suction chamber communicating with the suction duct 31 in the suction plate 22 through a neck cavity 72 (shown in broken lines in the figure) of the neck 71. As shown in fig. 7, which is a plan view of the suction arm 23, the proximal end 75 has a series of raised ridges 76 to facilitate connection of a suction line from a suction source to the suction arm 23.

Figure 8 is a detailed block diagram of a pair of spaced apart suction devices 12, 13 positioned on the heart. As shown, the suction plates 22, 27 of each suction device are typically placed in an area 34 where temporary fixation of heart tissue is desired. When used as a coronary bypass graft, the region 34 will typically have a coronary artery 35 passing through it. The area 34 is located between the suction plates 22, 27. Once the suction plate is placed around the area 34, a suction effect may be created in the suction openings (not shown). The device can be secured and grasped to the heart tissue by this suction.

Once suction has been generated and the suction plates secured to the heart tissue, each suction device is expanded slightly in the direction of arrows 40, 41 to the position shown in figures 42, 43. This spreading effect can result in a tension in the region 34 of cardiac tissue between the two suction plates. This tension force may further fix the region 34, particularly in the Z-direction, i.e. perpendicular to the plane defined by the surface of the heart. This is shown in fig. 9 and 10.

As shown in FIG. 9, even with such movement of the two suction plates, the region of cardiac tissue located between the two suction plates still has some vertical movement, as indicated by arrow 50. When the two suction plates 22, 27 are slightly spread apart, resulting in a tension in the region 34 of tissue between the two suction plates, the amount of movement by which the region 34 between the suction plates 22, 27 is moved due to the tension is further reduced, in particular in the Z-direction, i.e. perpendicular to the surface of the heart 1, as shown in fig. 10. After the suction plates 22, 27 have been positioned and secured in this manner and the tissue region has been temporarily fixed, the coronary artery in this region can be operated on.

In this embodiment, the coronary anastomosis procedure may be performed using any of a number of acceptable end-to-side or side-to-side techniques. Of course, other methods of performing an anastomosis, such as those performed endoscopically, may be used.

Fig. 11 is an example of motion in a plane parallel to the surface of the heart at a point on the heart tissue during the 1/2 breathing cycle when the heart is unconstrained, and also shows the motion at the same point on the heart tissue when the suction device is used. Line 60 is a trace of the motion of a certain point of a certain tissue on the surface of the heart. As shown by line 60, a point on the surface of the heart moves about 15 millimeters in each direction. In general, each loop of motion shows the motion of a beating heart over one heart cycle. Thus, one heart cycle produces one loop 61. The next heart cycle creates a loop 62, but the position of the entire heart will shift slightly due to the inflation and deflation of the two lungs in relation to breathing. Line 63 shows the movement of the same point on the heart tissue when the suction device is placed near said region and the heart wall is fixed by means of the invention. As shown, the effect of the present invention is to minimize the amount of movement of the heart wall in this region, i.e., movement in each direction by approximately 1 mm. This can best be seen in fig. 12, which is an enlarged view of fig. 11, particularly line 63, as shown by the movement of the heart wall having been reduced to only slightly more than 1 mm using the present invention. The amount of movement in the region of the suction device is reduced so that the still beating heart can be operated on by means of an endoscope or any other minimally invasive procedure.

Fig. 13 is another embodiment of the present invention. As shown, the embodiment of FIG. 13 includes a suction sleeve 80 connected to an annular suction head 81 by means of a ball bearing head 84. The ball bearing head 84 may be configured to remotely drive the suction head 81 from a location outside the chest. The suction head 81 has a series of suction ports 82 disposed along a first planar surface. In the embodiment shown, the flat surface on which the suction openings 82 are provided is conical in shape, but other types of flat surfaces, such as truncated cones for example, may be used. The suction head 81 may be configured to: each half of the suction device is connected to a separate suction source. With such a configuration, if one half of the suction head 81 is out of contact with the surface, the other half of the suction head 81 remains in the captured state. The suction sleeve 80 is used as described above. That is, the suction sleeve 80 itself is connected to a suction source (not shown, but identical to the suction source 114) and is secured to a fixed point, such as an operating table or a retractor (also not shown). The suction action by the suction source and the suction sleeve 80 will cause each suction port 82 to apply suction to the heart tissue. With this construction, the heart tissue in the central position of the suction sleeve is fixed. The break or opening 83 allows a blood vessel to be implanted while allowing the suction tip 81 to be secured to cardiac tissue. Specifically, if a mammary artery has been grafted end-to-side into a coronary artery, the openings 83 allow the suction tip 81 to be removed from around the grafted artery.

Fig. 14 is a view of the device temporarily immobilizing a local region of cardiac tissue using an alternate approach to access the interior of the body for a preferred mini-thoracotomy. In particular, an incision 2 is made through the patient's sternum in the heart 1 and the chest is opened by means of a retractor 3 to gain access to the interior of the heart 1. Contact with the heart 1 is also affected by traction on the pericardium 4 in the area of the heart 1 where it will be operated on. As shown, the traction of the pericardium is accomplished by means of sutures 5.

As shown, the fixture 11 includes a pair of suction devices 12, 13 and a suction source 114. The suction devices 12, 13 are fixed to the patient, each being fixed to the retractor 3 by means of a pair of clamps 19. Of course, the suction devices 12, 13 can also be fixed to the operating table (not shown in this figure, but with a fastening device as described above). The suction device is connected to a suction source 114 by means of lines 20, 21. The suction source 114 is preferably a standard suction source available in the operating room and is connected to the suction device by means of a two-liter buffer bottle (not shown) for each suction device. The suction provided is a negative pressure of 200-600 mm Hg, preferably 400 mm Hg. As shown, each suction device has two parts, a suction plate 22 and an arm 23.

Referring now to FIG. 15, FIG. 15 is another embodiment of the suction device 12 showing the suction device placed against the heart. As shown, the end of the suction device includes a suction plate 22 and an arm 23. The suction plate 22 has a substantially flat surface which substantially conforms to the curvature of the heart 1, only the contour of the heart 1 being shown. The suction plate 22 is connected to an arm 23 by a pin 24. The pin 24 allows the suction plate 22 to rotate at a preferred angle with respect to the arm 23, as shown, in which arm 23 there extends a suction chamber 30 communicating with a suction duct 31 in the suction plate 22. The suction duct 31 in turn leads through a suction aperture 32 (best seen in fig. 4) to a suction port 33.

Fig. 16 is a bottom view of the suction device 12 shown in fig. 15. As shown, it features four aligned suction ports 33, but the specific or exact number and location of ports used may vary.

Figure 17 is a further embodiment of the suction device 12 showing a suction device placed against the contours of the heart. As shown, the suction device 12 is substantially the same as that shown in FIG. 2, except for the suture loop 73 (suture). The sewing coil 73 is a tightly wound spring secured to the top surface of the suction plate 22. If desired, the site of the coronary anastomosis can be further temporarily stabilized by capturing the superior cardiac flap with a suture of low traction. The loop of suture 73 may be temporarily secured in place by wedging the suture (stitch) between the interior of the loop of suture 73 as is well known in the art.

Figure 18 is a bottom view of yet another embodiment of the suction device 12. As shown, the suction device 12 is substantially identical to that shown in FIG. 2, except that an electrode 174 is provided along one side of the suction device 12. The electrodes 174 are connected by leads 175 to a pulse generator 176. The electrodes 174, leads 175 and pulse generator 176 may be arranged according to well-known methods and materials to pace, cardiovert or defibrillate the heart while the suction device 12 is secured to the surface of the heart.

FIG. 19 is a cross-sectional view of a human body illustrating another method of contacting a heart surface and utilizing the present invention to fixate a tissue region. As shown, the suction device 12 is introduced through a first puncture wound. As mentioned above, the suction arm 23 of the suction device 12 is fastened to a stationary body, such as the operating table 16, by means of the fastening device 14. A second suction device may be introduced through a second puncture wound to tightly immobilize a localized region of tissue. Each suction device has a hood 180 made of latex rubber that fits over the end of the suction device as it penetrates the chest wall, thereby preventing blood and tissue from entering the suction ports and blocking the suction holes. Two or more additional guide trocars 78 may be introduced so that the heart 1 may be endoscopically examined and brought into contact for surgery. In addition, the left lung 79 may also be partially recessed, thereby providing an unobstructed area within which various surgical instruments may be operated.

Fig. 20A is a cross-sectional view of a human body showing an embodiment of the present invention, and in particular, another embodiment of the fastening device. In this embodiment, the fastening means comprises a pair of retaining recesses (anchors) 201, 202 secured to an operating table 203 by means of a base 204. As shown, the table is connected to a base plate 205 by a base 204. Each pocket is attached to each side of the table with a pair of fasteners 206, 207. In the preferred embodiment, the fasteners are a pair of screws that engage a longitudinal slot within each of the recesses, thereby allowing inward, outward, and up and down adjustment of the recesses, as oriented in the joint. As shown, the retainers are designed to follow the contours of the patient 210, thereby providing a smooth surface upon which to perform the procedure. Each retaining pocket is connected to the retractor 3 by fasteners 211, 212. To the retractor 3 is connected a mounting rail 999, which is clearly visible in fig. 20B described below. Also associated with the mounting rails are a pair of slide-and-clamp type holders 12A. 13A or other holder for quick but secure attachment or detachment of an object, mounted within each holder is a pair of suction devices 12B, 13B as described above. In the preferred embodiment, each of the retainers is a strip of biocompatible metal, such as stainless steel, having a width of about 5-8 cm and a thickness of about 0.6-0.8 cm. As shown, located on each pocket floor is a truss. Specifically, each pocket has a drop member 216, 217 secured thereto, each drop member being connected by a pair of cross braces 218, 219. It will be appreciated that by this structure, the stability of the retainers, and thus the stability of the suction device mounted thereon, can be improved.

Fig. 20B is a top view of the embodiment shown in fig. 20A. As shown, a mounting rail 999 is mounted to the retention pockets 201, 202. In the present embodiment, the shape of the mounting rail is elliptical. As shown, the mounting rails are used to mount the slide-and-clamp type holders 12A, 13A and their corresponding suction devices. For greater accuracy, the mounting rails allow to mount the suction devices firmly, but also to move them conveniently in the operating field. Moreover, the oval shape is more adapted to correspond to the surgical field. Of course, other shapes, such as circular, or asymmetric shapes, may also be employed. Of course, other configurations of mounting rails, retractors and retainers are possible, such as a retractor integral with each retainer, or a mounting rail integral with the retractor or both, to mention just two of many possibilities for ease of illustration.

In use, retraction to access the heart and chest wall is performed prior to positioning of the retainers. Once access to the heart is established, the retractor is attached to each retention socket and each retention socket is then secured to the operating table. The retractor is then fixed relative to the operating table and may provide a fixed body to which the fixing means, featuring the pair of suction means 12B, 13B, may be connected.

Fig. 21 and 22 show a further embodiment of the suction device. Fig. 21 is a perspective view of a fastening device. As shown, in this embodiment, the fastening means comprises a pair of profiled rails 220, 221. As shown, each rail is connected to the table 203 by a series of screws 222, 223. Although not shown in fig. 21 and 22, another feature of each rail is a truss-like structure, as shown in fig. 20A, that is disposed below the operating table to provide additional rigidity and stability. As shown, each guide rail is also angled inwardly, toward the patient 210 (shown in outline in FIG. 20A). So that the surgeon has access to the top of the patient. The wall between each rail is a mounting member 224. The mount is adjustable along the guide rail. Each mount is also designed to have a suction device mounted thereon. In this way, the mounting member 224 and the rails 220, 221 may provide a fixed body to which the suction device may be mounted.

Fig. 22 shows a top view of the guide rails 220, 221 for positioning a suction device on the heart. As shown, in this embodiment, two suction devices 225, 226 are fastened to the mount using a pair of slide-and-clamp type holders 12A, 13A as described above.

Referring now to fig. 23, fig. 23 is a side view of another embodiment of the suction device 12. As shown, this embodiment of the suction device 12 features a suction opening 33 as already described above. Each suction opening is connected to a suction duct 31 via a suction aperture 32, which has also been described above. However, in this embodiment, the suction device may also distribute the irrigation fluid over the area of the heart to be anastomosed. As shown, the flushing fluid source 133 is connected to the flushing fluid conduit 135 by a flushing line 134. As shown, the flush hose is designed to be somewhat flexible so that it can be rotated and moved through several angles, and is preferably a braided stainless steel hose. The flush hose dispenses a flush fluid at its end. The irrigation fluid is preferably a warm saline mist that prevents desiccation of the exposed tissue. In addition, the fluid is dispensed under pressure, and thus the salt spray has a force by which the coronary arteries are kept open, thereby facilitating the anastomosis procedure. The suction device also has an irrigation fluid return conduit. As shown, the flush fluid return conduit includes a flush return port 140 that is connected to a flush return conduit 141. The irrigation return conduit is connected to a suction source to aspirate irrigation return tube 142 and thereby reliably remove irrigation fluid from the surgical field. Although the suction device is shown as an integral part, the irrigation system and suction system may or may not be part of the suction device.

Figure 24 is another embodiment of a suction device. As shown, the suction device features a suction port, a suction duct, and a suction aperture as described above. However, in this embodiment, the suction device also has an optical fiber 150, one end of which is connected to the area of the suction device where the anastomosis is to be performed, and which is also connected to a light source 151. In this manner, the suction device may provide additional light 152 to the area where the anastomosis is to be performed.

Fig. 25 is a perspective view of another embodiment of a fixation device 11. As shown, in this embodiment, each suction device is connected to a mounting beam 998 by a pair of retaining members 12A, 13A, as also shown in fig. 20A. The mounting beam 998 is characterized by two sections, each of which can be rotated independently, or spread apart, or both. In particular, the mounting beam has central threads 997, 996. The end of each central threaded member has a drive knob 994, 995. Each knob may move a suction device mounted to a portion of the mounting beam away from or toward the center of the mounting beam as indicated by arrow 993. The mounting beam 998 is mounted to a solid object, such as a retractor, mounting rail, or mounting arm, via a central arm 992. Each suction device can be further rotated relative to the mounting beam simply by moving each associated device, as indicated by arrows 991, 990. When only one fixing arm is used, the suction device can be fixed by means of the mounting beam. In this manner, the mounting beam may allow both devices to be secured to a stationary object and may allow both suction devices to be moved apart, thereby providing additional securement to a localized area of tissue, as described above in connection with fig. 8-10.

Fig. 26A is a bottom view of another embodiment of the suction plate 22 employed in the fixing device. As shown, the suction plate has a series of suction ports, each of which is connected to a suction duct through a suction aperture. In this embodiment, the suction plate is characterized in that it has five suction ports. An additional suction port is provided on the side of the suction plate not adjacent to the coronary artery or the general surgical target, and this additional suction port can increase the surface area for suction. The diameter of each suction port 33 is 6mm, and the diameter of each suction hole 32 is 2 mm.

Fig. 26B is a perspective view of the bottom of another embodiment of the suction plate 22 employed in the fixing device. As can be seen in this embodiment, the orientation of the suction plate 22 relative to the neck 71 and the arms 23 is 90 degrees. Of course, the orientation of the suction plate relative to the neck may also be at other angles than 90 degrees. In this embodiment, the suction plate is characterized in that it has four suction ports, but more or less suction ports may be provided. The diameter of each suction port was 6mm, and the diameter of each suction hole was 2 mm.

Fig. 27 is a perspective view of a rotating handle 161 used to bend or orient the suction plate 22 of the fixture. As described above, the neck 71 is designed to be relatively bendable with respect to the suction plate 22 and the arm 23. As shown, the handle 161 features openings 980 having the same shape and size as the suction plate so that the suction plate can be inserted therein. Another feature of the handle is a neck portion 982 and a grip portion 981. The neck and grip are sized to provide a lever against the opening 980 and thus the suction plate, neck and arms. In use, the suction plate is inserted into the opening. After insertion, the neck region may be flexed by control of the grip portion relative to the arm. The use of such a handle is advantageous in avoiding the surgeon from straining the muscles of the hand to be controlled, as compared to bending the device by hand.

Fig. 28 is a bottom view of another embodiment of the fixation device 11. As shown, the fixture features a pair of suction plates 171, 172, each connected to an arm by a continuous hinge or neck as described above. The arm is in turn connected to a stationary object as also described above. In this embodiment, the arms are further secured to each other using a spreader (spreader) 180. As described above, the separation of the arms is performed when the suction plates cooperate with the suction of the heart surface, thereby locally increasing cardiac tension and thereby damping or reducing the motion of the heart surface due to the intrinsic beating of the heart. The stretcher may also provide additional stability to the suction plate, as it may act as a truss-like element.

Referring now to fig. 29, the stretcher 180 includes a pair of rods 181, 182 interconnected by a wing nut 183. One bar features a coupling pin 184 and the other bar features a coupling slot 185. Each rod is further connected to each respective arm of the fixation device by a respective lumen 186, 187. In such a manner, each rod member can be firmly connected to each arm. Manipulation of the rods in the longitudinal direction as indicated by arrow 188 allows the arms, and thus the suction plates, to be reliably positioned relatively close to or apart.

Fig. 30 shows another embodiment of the stretcher 180. As shown, the stretcher features a pair of rods connected to each arm of a respective suction device as described above. The two rods are further interconnected by means of a transmission 190. The transmission is in turn connected to an electric motor 191. As shown, the motor is further connected to a power source 192. Connected to the motor and power source is a controller 193. The controller may automatically detect the amount of stretch in the suction device produced by the stretcher. In the preferred embodiment, the controller senses the amount of power or energy required by the motor to further extend the stretcher and thus separate the suction plates. When a threshold amount is reached, the controller shuts off power to the motor, thereby locking the stretcher in the present position. This feature allows the stretcher to automatically stretch the suction plates apart to a degree sufficient to dampen wall motion and not allow the stretcher to spread the suction plates too far apart causing a heart wall trapping phenomenon due to loss of suction. Of course, other designs for controlling the extension of the suction plate may be used, such as other mechanically or hydraulically driven or controlled systems.

Fig. 31 shows another embodiment of a fixing device, in particular, another embodiment of a fixing device for fixing suction plates. As shown, the system features a pair of arms 351, 352 having a ball and socket configuration. As shown, each arm is characterized in that it is provided at its free end with a holder 12A and 13A of the sliding and clamping type as described above. Each arm is mounted at both ends in a base 970, 971. Each base can be locked to one rail clamp 968, 969 that is locked to the rails 901, 902 at the side edges of the operating table 203. The bottom of the track clamp is provided with lock actuators 967, 968. The lock actuator may cooperate with the arm to lock the arm in place when the corresponding handle is rotated in one of the directions indicated by arrow 965. In particular, the locking actuator may tighten the cable within the respective arm, thereby locking the arm in place via the ball and socket arrangement. The bottom of each locking driver is provided with a truss. In particular, each locking actuator has a drop element 216, 217 secured thereto, each drop element being hinged to one another by a pair of cross braces 218, 219. The crossing struts may or may not be connected to each other at their midpoints. It will be appreciated that by virtue of the truss structure, the stability of the fixture, and thus the suction device mounted thereon, may be improved, as discussed earlier in connection with fig. 20A.

Figure 32 is a cross-sectional view of the arm shown in figure 31, particularly illustrating details of the ball and socket arrangement. Only one portion is shown in this figure to illustrate the ball and socket arrangement. Each tube 800 (several of which are used to create the arms) has an end configuration to match the shape of the sphere 801, i.e., the respective end of each tube has a hemispherical space with a radius corresponding to the outer surface of the sphere, so that a larger portion of the tube can contact the sphere than if the end of the tube were taken only straight. This geometry increases the surface area between the tube and the ball, thereby enhancing the stability of the arm when held in place. Each sphere 801 also has an inner sleeve 802. As shown, the inner liner is shaped to have a tapered opening 803 at each end. A pull cable 804 is provided along the length of the arm, particularly within each of the tubular elements and the ball. The cable is preferably constructed of (kevlar) and has a polyurethane coating and is fastened to one end of the arm so that by tightening the cable the ball and the tube portion are brought into contact with each other and secured to each other by friction. The operation of the arm is as follows. The tubular element can easily slide relative to the ball when there is no tension on the cable. However, the tension acting on the cable may increase the friction between the tube and the ball. Sufficient tension may cause the ball and tube to become immobile relative to each other. The taper in the bushing 802 allows the cable to maintain the same length regardless of the orientation of the tube element and ball. That is, if the arms are curved and have a certain radius of curvature, the taper allows the cable to maintain the same length. This allows the arm to be moved more easily and then locked into place.

Fig. 33 shows another embodiment of the invention, in particular a suction device substantially similar to that shown in fig. 13, but with the two sets of suction openings on top of the suction plate. As shown, each suction line has a cock 861, 862 so that one or both sets of associated suction ports can be disconnected individually from their suction sources. The arm 823 contains an internal lumen for each suction line, and ends from which the necks 871, 872 extend. As mentioned above, each neck is designed to be curved. A suction plate is mounted to the neck and features an annular array of suction ports located on an upper surface of the suction plate opposite the arm as shown. The suction plate is characterized by 16 suction openings, one group of 8 along one side 81 connected to one suction line and a second group of 8 along the other side 82 connected to the other suction line. With this arrangement, even if one side loses its ability to capture tissue and the other side is still connected to a source of suction, the pressure on that side is still on and the capture ability in that area is maintained. In the embodiment shown, the suction openings are arranged along a substantially conical plane at the top of the suction plate, but other types of planes, such as a truncated conical plane, may be used. The orientation of the suction ports along the top of the annular suction plate is particularly useful for accessing the back or dorsal surface of the heart to move or reposition the heart to better access difficult to access areas.

To facilitate exposure of the surgical site, a retractor, such as a spoon-shaped probe, in combination with a fixation device may also be used to remove other tissue from the surgical site.

As mentioned above, the present invention relates to a method and apparatus for immobilizing tissue. In the preferred embodiment, the invention is used to immobilize heart tissue during a coronary bypass graft procedure without cardiopulmonary bypass by opening or closing the chest cavity, however, other surgical techniques requiring immobilization of body tissue, such as organs like the stomach, gall bladder, and other body tissues like the eyes or skin, can also be performed using the invention. Furthermore, while the invention has been described in detail above with respect to a preferred embodiment and several variations thereof, it will be understood that various modifications or alterations may be effected within the scope of the appended claims. Such variations include alternative elements or components that perform substantially the same function, in substantially the same manner, to achieve substantially similar results as described above.

Claims (40)

1. An apparatus for temporarily immobilizing an area of tissue, comprising:

a member (12) having a lumen (30, 31) connected to a suction port (33) disposed along a first planar surface of the member, the lumen connected to a source of suction, suction applied to the lumen leading to the suction port; and

means (14, 15) for fixing said member to a fixed body; wherein said member comprises an arm (23) and a suction plate (22), said first surface being located on said suction plate for grasping a selected area of said tissue;

characterized in that it further comprises connection means (71) connecting said arm (23) and said suction plate (22) and allowing said suction plate (22) to move, rotate or lock with respect to said arm (23).

2. The device according to claim 1, wherein said connecting means comprises a freely movable neck (71) having a proximal end and a distal end, said distal end being connected to said arm (23) and said distal end being connected to said suction plate (22).

3. The device of claim 1, wherein said connecting means comprises a bendable portion.

4. The apparatus of claim 1, wherein said connecting means comprises a pin.

5. The device of claim 1, wherein said connection means comprises a ball and socket (84).

6. A device according to claim 1, characterized in that the suction plate (22) can be fixed to the arm (23) at an angle by means of the connecting means.

7. The device according to claim 1, characterized in that said first flat surface of said member (12) is curved.

8. The device according to claim 1, characterized in that the inner chamber (30, 31) extends through the arm (23) to the suction plate (22) and also through the arm to the suction opening (33) which is located on the suction plate (22).

9. The device of claim 1, said stationary body being an operating table (16).

10. Device according to claim 1, characterized in that said fixed body is a retractor (3).

11. The apparatus of claim 1, further comprising:

a second member (13) having a second suction opening (33), said second member being spaced from said first member (12) so as to define a fixed area therebetween;

a fastening means (14, 15) for fastening the first and second members to a fixed body, the fastening means being connected to the first and second members.

12. A device according to claim 11, wherein said second member (13) has a suction opening (33) arranged along said first flat surface.

13. A device according to claim 11 or 12, wherein the fastening means comprises a first variable friction arm (14, 15) having a first lockable toggle (17); and a second variable friction arm (14, 15) having a second lockable toggle (17).

14. The apparatus of claim 11 or 12, further comprising: a first suction source (114) connected to the first member and in communication with the suction port of the first member; and a second suction source (114) connected to the second member and communicating with the suction port of the second member.

15. The device of claim 11, further comprising a means (180) for spreading said first and second members apart.

16. The device of claim 15, wherein the means (180) for spreading the first and second members apart comprises a first rod secured to the first member, the first rod having a linear slot, and a second rod connected to the second member, the second rod having means for engaging the linear slot and securing the second rod to the first rod.

17. A device according to claim 15 or 16, wherein the means for spreading the first member apart from the second member comprises motor means (191) connected to the first and second rods for moving the first rod away from the second rod; a power unit (192) coupled to said motor unit to power said motor unit; and a control device (193) coupled to the motor means and the power means for controlling operation of the motor means.

18. The device of claim 1, wherein the member further comprises means (140, 141) for dispensing flushing fluid to an area immediately adjacent the member.

19. The device according to claim 18, wherein said member further comprises a means (142) for removing the flushing fluid dispensed by the means for dispensing flushing fluid.

20. The apparatus of claim 18 or 19, wherein the means for dispensing the flushing fluid further comprises means for dispensing the flushing fluid at a pressure.

21. The device of claim 1, wherein the member further comprises means (151) for transmitting light to an area proximate the member.

22. The device according to claim 1, wherein said means for fixing said structure to a fixed body comprise a shaped retention recess (201, 202) made of rigid, biocompatible material.

23. The device according to claim 22, characterized in that the fixing socket is fixed to an operating table (16).

24. The device according to claim 1, characterized in that said means for fixing said element to a fixed body comprise a first and a second shaped fixing socket (201, 202) made of rigid, biocompatible material, said first fixing socket being fixed to a first side of the operating table and said second fixing socket being fixed to a second side of the operating table.

25. The apparatus of claim 24, wherein the first and second recesses are connected by a truss (218, 219) connected to each of the bottom ends of a first and second recess, the truss being positioned below the operating table.

26. Device according to claim 24 or 25, characterized in that a retractor (3) is associated with said first and second retention pockets.

27. The device as in claim 24 or 25, wherein a mounting rail (999) is associated with said first and second retention pockets.

28. A device according to claim 26, characterized in that a mounting rail (999) is connected to the retractor (3).

29. The apparatus as claimed in claim 25, wherein the truss includes a first descending member (216) fixed to the first retaining recess (201) and a second descending member (217) fixed to the second retaining recess (202), and a first and a second brace (218, 219) are cross-coupled to each other and fixed to the first and the second descending members.

30. The device of claim 1 wherein the member has a first circular side including the first set of suction ports and a second circular side including the second set of suction ports, the member further having means for allowing the first and second sets of suction ports to be independently connected to and disconnected from the suction source.

31. The device according to claim 1, characterized in that the suction source (114) has a first suction line (20) and a second suction line (21), each suction line having a cock (861, 862) for selectively transmitting suction along each suction line, each suction line being connected to the member, the member having an arm with a first lumen into which the first suction line is connected and a second lumen into which the second suction line is connected, a first flexible neck (71) being connected to the first lumen and a second flexible neck being connected to the second lumen, and a ring having a first circular arm with a first set of suction openings and a second circular side with a second set of suction openings, the ring being connected to the first and second neck, suction in the first line can thus be transferred to the first set of suction openings and suction from the second line can be transferred to the second set of suction openings.

32. The apparatus of claim 1, wherein the means for securing the member to a stationary body comprises a mounting beam (998) having means for securing a member to the mounting beam, the mounting beam having a first portion and a second portion, means for spreading the first portion away from the second portion, and means for mounting the mounting beam to a stationary body.

33. The apparatus of claim 1 wherein the member has first, second and third suction ports in the first surface aligned with one another, each of the suction ports being in communication with a suction source, wherein suction from the suction source is directed to each of the suction ports.

34. The apparatus of claim 33 further comprising a fourth suction port in said first surface, said fourth suction port being positioned adjacent to the first, second and third suction ports, said first, second and third suction ports being positioned within said first surface in a first line with respect to each other.

35. The device according to claim 1, characterized in that said means for fixing said member to a fixed body comprise a ball and socket arm (800, 801).

36. The device of claim 35, wherein said socket arm comprises a first tube (800) connected at a first end to a spherical ball (801) having a spherical radius, said first end in the shape of a hemisphere having a radius substantially equal to the spherical radius.

37. The device of claim 36, wherein said ball has an interior cavity extending therethrough, a tapered bushing (802) having a passageway with a first diameter at a first end, a second diameter at a mid-section portion, and a first diameter at an end opposite said first end, said first diameter being greater than said second diameter is provided with said interior cavity.

38. The device of claim 1 wherein the means for securing the member to a fixture includes a ball and socket arm having a series of tube portions connected by a series of ball portions, the tube portions having ends that mate with the ball portions, each end being hemispherical in shape to correspond to each ball portion, a cable passing through the series of ball portions and the tube portions, each ball portion having means for maintaining equal lengths of cable inside the arm regardless of the orientation of any tube portion relative to an adjacent ball portion.

39. The device of claim 37, wherein the means for maintaining equal lengths of cable inside the arm regardless of the orientation of either tube portion with respect to the adjacent ball portion comprises a tapered bushing disposed within the interior cavity of the ball, the tapered bushing having a passageway with a first diameter at a first end portion, a second diameter at a middle portion, and a first diameter at an end opposite the first end portion, the first diameter being greater than the second diameter.

40. The device according to claim 1, wherein said tissue is epicardial tissue of a beating heart, said suction port (33) being adapted to suck on said tissue to grasp said tissue when suction is applied to said suction port (33).