Source: http://www.google.com/patents/US6464629?dq=6437692
Timestamp: 2014-07-11 01:26:53
Document Index: 670391313

Matched Legal Cases: ['art. 2', 'art.\n3', 'art. 4', 'art.\n20', 'art. 21', 'art.\n36']

Patent US6464629 - Method and apparatus for temporarily immobilizing a local area of tissue - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsThe invention is a method and apparatus for performing beating heart surgery, in which a single articulating arm supports multiple suction pods. Once the suction pods are applied to the heart surface, tightening a cable fixes the arm in place. Then, the suction pods may be spread apart from each other...http://www.google.com/patents/US6464629?utm_source=gb-gplus-sharePatent US6464629 - Method and apparatus for temporarily immobilizing a local area of tissueAdvanced Patent SearchPublication numberUS6464629 B1Publication typeGrantApplication numberUS 09/396,047Publication dateOct 15, 2002Filing dateSep 15, 1999Priority dateSep 15, 1998Fee statusPaidAlso published asCA2344393A1, CA2344393C, DE69935771D1, DE69935771T2, EP0993806A2, EP0993806A3, EP0993806B1, US6740028, US7201716, US20020161277, US20040167549, US20070123747, WO2000015119A2, WO2000015119A3, WO2000015119A9Publication number09396047, 396047, US 6464629 B1, US 6464629B1, US-B1-6464629, US6464629 B1, US6464629B1InventorsEric Boone, Jack Goodman, John D. Hall, William G. O'Neill, Vincent J. Testa, Eric Vroegop, Cornelius Borst, Hendricus J. Mansvelt-Beck, Paul F. Gr�ndemanOriginal AssigneeMedtronic, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (105), Non-Patent Citations (39), Referenced by (28), Classifications (14), Legal Events (6) External Links: USPTO, USPTO Assignment, EspacenetMethod and apparatus for temporarily immobilizing a local area of tissueUS 6464629 B1Abstract The invention is a method and apparatus for performing beating heart surgery, in which a single articulating arm supports multiple suction pods. Once the suction pods are applied to the heart surface, tightening a cable fixes the arm in place. Then, the suction pods may be spread apart from each other to tighten the surface of the cardiac tissue lying between the suction pods. In one embodiment, fixation of the arm as well as the spreading apart of the suction pods may occur concurrently or almost concurrently through the tensioning of a single cable. Additional embodiments of the method, system and its components are shown.
What is claimed: 1. A system for temporarily immobilizing an area of tissue comprising:
an articulating arm comprising a plurality of links, the arm having a proximal end and a distal end, the articulating arm having an articulating condition in which the links are free to move relative to one another so that the arm articulates, and a locked condition in which the links are locked relative to one another so that the arm is rigid; a paddle assembly connected to the distal end of the articulating arm and including first and second paddles each having means for engaging tissue, the first and second paddles being movable from an initial position and a spread position farther apart than the initial position for tensioning tissue between the first and second paddles; and spreading means, operable in a single operation, for changing the articulating arm from the articulating condition to the locked condition and moving of the first and second paddles from the initial position to the spread position so that the articulating arm is rigid when the first and second paddles are spread apart. 2. The system according to claim 1 wherein the spreading means includes a rotatable handle mounted adjacent the proximal end of the articulating arm, the single operation comprising rotating the handle to spread the first and second paddles from the initial position to the spread position and change the articulating arm from the articulating condition to the locked condition so that the articulating arm is rigid when the first and second paddles are spread apart.
3. The system according to claim 2 wherein the spreading means further includes:
a cable extending through the links of the articulating arm, the cable having a distal end and a proximal end coupled to the rotatable handle; a cable stop coupled to the distal end of the articulating arm and to the distal end of the cable, and a spreadable saddle coupled to the first and second paddles and to the distal end of the articulating arm, the spreadable saddle comprising a first inclined surface wherein the cable stop will slide upon the first inclined surface as the cable receives a first amount of tension from a first amount of rotation of the rotatable handle causing the articulating arm to change from the articulating condition to the locked condition, the spreadable saddle further comprising a second inclined surface wherein the cable stop will slide upon the second inclined surface as the cable receives a second amount of tension from a second amount of rotation of the rotatable handle causing the spreadable saddle to spread the first and second paddles apart. 4. The system according to claim 2 wherein the paddle assembly has a rotatable condition in which the paddle assembly is free to rotate relative to the articulating arm, and a locked condition in which the paddle assembly is locked in a position relative to the articulating arm; the spreading means further including:
a cable extending through the links of the articulating arm, a split ball coupled to the first and second paddles, the split ball being compressible to move the first and second paddles from the initial position to the spread position; a head link mounted on the distal end of the articulating arm; a sling holding the split ball against the head link, the sling being mounted on the head link for motion relative to the head between: (a) a first position in which the split ball is free to rotate relative to the sling and head link so that the paddle assembly is in the rotatable condition; and (b) a second position, wherein the split ball is compressed between the sling and head link to: (i) prevent rotation of the split ball relative to the sling and head link so that the paddle assembly is in the locked condition; and (ii) compress the split ball to move the first and second arms to the spread position; the sling being coupled to the distal end of the cable such that tightening of the cable by rotation of the rotatable handle causes the sling to move from the first to the second position, thereby causing the paddle assembly to change from the rotatable condition to the locked condition and the first and second paddles to move to the spread position. 5. The system according to claim 1 further comprising means for fixing the proximal end of the articulating arm to a stationary object.
6. The system according to claim 5 wherein the means for fixing the proximal end of the articulating arm to a stationary object comprises a clamp adapted to clamp on a retractor.
7. The system according to claim 1 further comprising means for dispensing a medicinal substance into the immobilized area of tissue.
8. The system according to claim 7 wherein the medicinal substance is selected from the group consisting of drugs, agents, anti-clotting agents, clotting agents, steroids, antibiotics, growth factors, genetically acting agents or anti arrhythmic agents.
9. The system according to claim 7 wherein the means for dispensing a medicinal substance includes a series of hollow tissue puncturing cleats located on a tissue-contacting bottom surface of the first paddle, the series of hollow tissue puncturing cleats being coupled to a dispensing reservoir containing the medicinal substance.
10. The system according to claim 1 wherein the means for engaging tissue includes a suction source, at least one suction port located along a tissue-contacting bottom surface of the first and second paddles, and a means for coupling the suction ports to the suction source.
11. The system according to claim 1 wherein the means for engaging tissue includes a series of ridges located along a tissue-contacting bottom surface of the first and second paddles.
12. The system according to claim 1 wherein the means for engaging tissue includes one or more burrs or barbs located along a tissue-contacting bottom surface of the first and second paddles.
13. The system according to claim 1 wherein the links vary in size along the length of the articulating arm, with the links in the most proximal portion of the articulating arm being largest, the links in the most distal portion the smallest and the middle portion somewhere in between.
14. The system according to claim 1 wherein the links each have a proximal end having a hemispherical indentation and a distal end having a hemispherical protrusion, wherein the hemispherical shapes of adjacent links are nearly identical, such that the links rotate smoothly against one another when the articulating arm is in the articulating condition.
15. The system according to claim 14 wherein a surface of the hemispherical protrusion and a surface of the hemispherical indentation has a roughened texture.
16. The system according to claim 14 wherein a surface of the hemispherical protrusion and a surface of the hemispherical indentation has a series of interlocking dimples and depressions.
17. The system according to claim 1 wherein the articulating arm is covered with a thin walled elastomeric sheath.
18. A system for temporarily immobilizing an area of tissue comprising:
an articulating arm comprising a plurality of links, the arm having a proximal end and a distal end, the articulating arm having an articulating condition in which the links are free to move relative to one another so that the arm articulates, and a locked condition in which the links are locked relative to one another so that the arm is rigid; a paddle assembly having a first paddle and a second paddle with the first and second paddles being spreadable from an initial position and a spread position farther apart than the initial position, the first paddle having a first tissue-contacting bottom surface for engaging tissue and the second paddle having a second tissue-contacting bottom surface for engaging tissue; a cable extending through the links of the articulating arm, the cable having distal and proximal ends, the distal end of the cable being connected to the paddle assembly; a cable tensioning mechanism connected to the proximal end of the cable and engaging the proximal end of the articulating arm to pull the cable relative to the articulating arm when the cable is tensioned to (a) pull the links of the articulating arm together to change the articulating arm from the articulating condition to the locked condition, and (b) move the first and second paddles from the initial position to the spread condition. 19. The system according to claim 18 wherein the cable tensioning mechanism includes a rotatable handle mounted adjacent the proximal end of the articulating arm and connected to the cable such that rotating the handle spreads the first and second paddles from the initial position to the spread position and changes the articulating arm from the articulating condition to the locked condition so that the articulating arm is rigid when the first and second paddles are spread apart.
20. The system according to claim 19 wherein the cable tensioning mechanism further includes:
a cable stop coupled to the distal end of the articulating arm and to the distal end of the cable, and a spreadable saddle coupled to the first and second paddles and to the distal end of the articulating arm, the spreadable saddle comprising a first inclined surface wherein the cable stop will slide upon the first inclined surface as the cable receives a first amount of tension from a first amount of rotation of the rotatable handle causing the articulating arm to change from the articulating condition to the locked condition, the spreadable saddle further comprising a second inclined surface wherein the cable stop will slide upon the second inclined surface as the cable receives a second amount of tension from a second amount of rotation of the rotatable handle causing the spreadable saddle to spread the first and second paddles apart. 21. The system according to claim 19 wherein the paddle assembly has a rotatable condition in which the paddle assembly is free to rotate relative to the articulating arm, and a locked condition in which the paddle assembly is locked in a position relative to the articulating arm; the cable tensioning mechanism further including:
a split ball coupled to the first and second paddles, the split ball being compressible to move the first and second paddles from the initial position to the spread position; a head link mounted on the distal end of the articulating arm; a sling holding the split ball against the head link, the sling being mounted on the head link for motion relative to the head between: (a) a first position in which the split ball is free to rotate relative to the sling and head link so that the paddle assembly is in the rotatable condition; and (b) a second position, wherein the split ball is compressed between the sling and head link to: (i) prevent rotation of the split ball relative to the sling and head link so that the paddle assembly is in the locked condition; and (ii) compress the split ball to move the first and second arms to the spread position; the sling being coupled to the distal end of the cable such that tightening of the cable by rotation of the rotatable handle causes the sling to move from the first to the second position, thereby causing the paddle assembly to change from the rotatable condition to the locked condition and the first and second paddles to move to the spread position. 22. The system according to claim 18 further comprising a clamp, adapted to clamp on a retractor, coupled to the proximal end of the articulating arm for fixing the articulating arm to a stationary object.
23. The system according to claim 18 further comprising a series of hollow tissue puncturing cleats for injecting a medicinal substance into the immobilized area of tissue, the hollow tissue puncturing cleats located on the tissue-contacting bottom surface of the first paddle, the series of hollow tissue puncturing cleats being coupled to a dispensing reservoir containing a medicinal substance.
24. The system according to claim 23 wherein the medicinal substance is selected from the group consisting of drugs, agents, anti-clotting agents, clotting agents, steroids, antibiotics, growth factors, genetically acting agents or anti arrhythmic agents.
25. The system according to claim 18 wherein the tissue-contacting bottom surface of the first and second paddles comprises one or more suction ports.
26. The system according to claim 18 wherein the tissue-contacting bottom surface of the first and second paddles comprises a series of ridges.
27. The system according to claim 18 wherein the tissue-contacting bottom surface of the first and second paddles comprises one or more burrs or barbs.
28. The system according to claim 18 wherein the links vary in size along the length of the articulating arm, with the links in the most proximal portion of the articulating arm being largest, the links in the most distal portion the smallest and the middle portion somewhere in between.
29. The system according to claim 18 wherein the links each have a proximal end having a hemispherical indentation and a distal end having a hemispherical protrusion, wherein the hemispherical shapes of adjacent links are nearly identical, such that the links rotate smoothly against one another when the articulating arm is in the articulating condition.
30. The system according to claim 29 wherein a surface of the hemispherical protrusion and a surface of the hemispherical indentation has a roughened texture.
31. The system according to claim 29 wherein a surface of the hemispherical protrusion and a surface of the hemispherical indentation has a series of interlocking dimples and depressions.
32. The system according to claim 18 wherein the articulating arm is covered with a thin walled elastomeric sheath.
33. A surgical method comprising the following steps:
providing a stabilization system comprising an articulating arm having proximal and distal ends, and first and second paddles mounted on the distal end of the articulating arm, each paddle having a tissue-engaging surface; accessing a desired area of tissue of a patient; placing the tissue-engaging surfaces of the first and second paddles upon the surface of the tissue to define an area of tissue to be stabilized between the first and second paddles; in a single operation, spreading of the first and second paddles to tension the area of tissue to be stabilized between the first and second paddles and locking the articulating, arm so that the articulating arm is rigid when the first and second paddles are spread apart; and performing a surgical procedure on or adjacent the area of tissue stabilized between the first and second paddles. 34. The surgical method of claim 33 further comprising fixing the proximal end of the articulating arm to a stationary object.
35. The surgical method of claim 33 wherein the tissue is tissue of a beating heart, the step of performing a surgical procedure on or adjacent the area of tissue stabilized between the first and second paddles comprising performing a surgical procedure on a beating heart.
36. The surgical method of claim 33 further comprising pulling suction through the tissue-engaging surfaces of the first and second paddles to grasp the tissue to the tissue-engaging surfaces.
37. The surgical method of claim 33 wherein the surgical procedure is performing a coronary artery bypass graft.
38. The surgical method claim 33 further comprising injecting a medicinal substance into the stabilized area of tissue.
39. A system for temporarily immobilizing an area of tissue comprising:
an articulating arm comprising a plurality of links, the arm having a proximal end and a distal end, the articulating arm having an articulating condition in which the links are free to move relative to one another so that the arm articulates, and a locked condition in which the links are locked relative to one another so that the arm is rigid; a cable extending through the links of the articulating arm, the cable having distal and proximal ends; a paddle assembly connected to the distal end of the cable, the paddle assembly having a rotatable condition in which the paddle assembly is free to rotate relative to the articulating arm, and a locked condition in which the paddle assembly is locked in a position relative to the articulating arm, the first paddle having a first tissue-contacting bottom surface for engaging tissue and the second paddle having a second tissue-contacting bottom surface for engaging tissue; a cable tensioning mechanism connected to the proximal end of the cable and engaging the proximal end of the articulating arm to pull the cable relative to the articulating arm when the cable is tensioned to (a) pull the links of the articulating arm together to change the articulating arm from the articulating condition to the locked condition, and (b) change the paddle assembly from the rotatable condition to the locked condition. 40. The system according to claim 39 wherein the cable tensioning mechanism comprises a rotatable handle mounted adjacent the proximal end of the articulating arm and connected to the cable such that rotating the handle tensions the cable to change (i) the articulating arm from the articulating condition to the locked condition and (ii) the paddle assembly from the rotatable condition to the locked condition.
41. The system according to claim 40 wherein the cable tensioning mechanism further comprises:
a ball coupled to the first and second paddles; a head link mounted on the distal end of the articulating arm;+
a sling holding the ball against the head link, the sling being mounted on the head link for motion relative to the head between: a first position in which the ball is free to rotate relative to the sling and head link so that the paddle assembly is in the rotatable condition; and a second position, wherein the ball is compressed between the sling and head link to prevent rotation of the ball relative to the sling and head link so that the paddle assembly is in the locked condition; the sling being coupled to the distal end of the cable such that tightening of the cable by rotation of the rotatable handle causes the sling to move from the first to the second position, thereby causing the paddle assembly to change from the rotatable condition to the locked condition. 42. The system according to claim 41 wherein the sling is generally U-shaped with two legs, the head link includes channels for slidably receiving the legs of the sling to allow the sling to move between the first and second position but preventing rotation of the sling relative to the head link.
43. The system according to claim 42 wherein the distal end of the cable has a tabbed element, and the sling has slots that receive the tabbed element to connect the sling to the distal end of the cable.
44. The system according to claim 43 further comprising a compression limiter mounted between the tabbed element and the head link for limiting compression of the ball.
45. The system according to claim 39 further comprising a clamp, adapted to clamp on a retractor, coupled to the proximal end of the articulating arm for fixing the articulating arm to a retractor.
46. The system according to claim 45 wherein the clamp comprises:
a mount attached to the proximal end of the articulating arm, the handle engaging the mount and the cable connecting to the handle through the mount; a jaw mounted on the mount, the mount and jaw defining a dovetail-shaped groove for receiving a retractor element, the jaw being spring biased relative to the mount to clamp the retractor element within the dovetail-shaped groove and being movable against the bias to release the retractor element; and a manually operable cam mechanism for locking the jaw relative to the mount. 47. The system according to claim 39 wherein the tissue-contacting bottom surface of the first and second paddles comprises one or more suction ports.
48. The system according to claim 39 wherein the tissue-contacting bottom surface of the first and second paddles comprises a series of ridges.
49. The system according to claim 39 wherein the tissue-contacting bottom surface of the first and second paddles comprises one or more burrs or barbs.
50. The system according to claim 39 wherein the links vary in size along the length of the articulating arm, with the links in the most proximal portion of the articulating arm being largest, the links in the most distal portion the smallest.
51. The system according to claim 50 wherein the links in portion of the arm intermediate the proximal and distal portion are intermediate in size between the links in the most proximal portion of the articulating arm and the links in the most distal portion.
52. The system according to claim 39 wherein the links each have a proximal end having a hemispherical indentation and a distal end having a hemispherical protrusion, wherein the hemispherical shapes of adjacent links are nearly identical, such that the links rotate smoothly against one another when the articulating arm is in the articulating condition.
53. The system according to claim 52 wherein a surface of the hemispherical protrusion and a surface of the hemispherical indentation has a roughened texture.
54. The system according to claim 52 wherein a surface of the hemispherical protrusion and a surface of the hemispherical indentation has a series of interlocking dimples and depressions.
55. The system according to claim 39 wherein the first and second paddles being spreadable from an initial position and a spread position farther apart than the initial position, the cable tensioning mechanism being connected via the cable to the paddle assembly to move the first and second paddles from the initial position to the spread condition.
This application claims benefit of Provisional No. 60/100,443 filed Sep. 15, 1998.
Current beating heart bypass surgery techniques demand relatively motionless epicardial tissue in the immediate vicinity of an anastomosis. Several systems are presently available which attempt to immobilize epicardial tissue in the immediate vicinity of an anastomosis through a simple mechanical fork. One of the many such systems presently available includes the Access� system available from CardioThoracic Systems Inc., Cupertino, Calif. Such a system stabilizes the heart by pressing a fork downwards onto the heart surface. Through this pressure the region of the epicardium between the fork is immobilized. Commercially available systems use short arms mounted to retractors in close proximity to the chest cavity. Mechanical fork systems only operate successfully on vessels that can be immobilized by applying pressure in a downward direction. These systems are very useful for operations on the anterior portion of the heart (such as the left anterior descending artery). However, fork systems are limited in their ability to maneuver a vessel into better view or for operating on the posterior portion of the heart. That is, fork systems are limited in their ability to �present� a vessel to the surgeon. This is a even greater drawback since fork systems stabilize only through compression, therefore often pushing downwards the are of surgical interest. In addition, compression of the heart can lead to diminished cardiac output, presenting a further risk to the patient's well-being. Finally, such systems, to date, have often featured rigid, inflexible arms which often interfere with the view or movements or both of the surgeon.
Suction stabilization systems, such as the Medtronic Octopus� Tissue Stabilizer and Accessories (available from Medtronic, Inc., Minneapolis, Minn. USA), use comparatively long, dual reusable articulating arms configured with clamps at their distal ends to secure suction based tissue stabilizers. During use, the arms are typically secured to a rail on the side of the operating table. The suction grips and immobilizes the surface of the heart. Additionally, the system allows the surgeon to manipulate the anastomosis site into better view by rotating and supporting the heart. The system also allows the surgeon to apply tension to the tissue between the stabilizers. Thus, the system is much more versatile than mechanical fork style systems. The suction paddles or pods can attach to and immobilize the heart, and can be used to manipulate the heart into better position so that the more difficult to reach vessels can be bypassed.
Many surgeons have used the Medtronic Octopus� Tissue Stabilizer system to perform as many as five or six vessel bypasses. Some surgeons, in fact, report using the product on 50-90% of their cases. Nonetheless such a system is still in need of improvement. For example, such a system was relatively more cumbersome to set up than desired, requiring each stabilization arm to be individually fixed or immobilized. Moreover, because each arm worked individually, spreading the arms relatively apart was more difficult than desired. Finally, because the degree of spreading was not limited in any way, surgeons could spread the paddles apart at greater distance than desired, causing one or both paddles to spontaneously lose capture of the tissue.
SUMMARY OF THE INVENTION The invention is a method and apparatus for performing beating heart surgery, in which a single articulating arm supports multiple suction paddles of pods. Once the suction pods are applied to the heart surface, tightening a cable fixes the arm in place. Then, the suction pods may be spread apart from each other to tighten the surface of the cardiac tissue lying between the suction pods. In one embodiment, fixation of the arm as well as the spreading apart of the suction pods may occur concurrently or almost concurrently through the tensioning of a single cable. Additional embodiments of the method, system and its components are shown.
FIGS. 1-A through 1-F show various views of the invention.
DETAILED DESCRIPTION OF THE PRESENT INVENTION The present invention is a method and apparatus for performing beating heart surgery, in which a single articulating arm supports multiple suction pods or other pods which may be used to grip or engage heart tissue and thus inhibit its motion. In one embodiment, once the suction pods are applied to the heart surface, tightening a cable fixes the arm in place. Then, the suction pods may be spread apart from each other to tighten the surface of the cardiac tissue lying between the suction pods. In one embodiment, fixation of the arm as well as the spreading apart of the suction pods may occur concurrently or almost concurrently the tensioning of a single cable. Additional embodiments of the system and its components are shown. Support for conventional aspects of the invention may be found in the enclosed documents, all of which are incorporated by reference in their entirety.
FIG. 1-A is a perspective view of a preferred embodiment of the invention. An articulating arm 20 is attached to support 24 on the proximal end of the arm, and terminates with tightening/spreading mechanism 21 at the distal end of the arm. On the opposite, more proximal, end of support 24 is handle 23. Distally beyond tightening/spreading mechanism 21 is a plurality (as shown, two) of suction paddles or pods 22, generally disposed along the same plane. Each suction pod 22 can be connected to a suction source or vacuum (Shown in FIG. 2) by a conventional connection 325 that lies at the proximal end of pod 22. Each pod and its suction ports disposed along the bottom surfaces 1 may be shaped and constructed in any acceptable manner, such as the same as those used in the Medtronic Octopus� tissue stabilizer. Clamp 26 lies below support 24 and is designed to attach the entire device to conventional surgical retractors and other similar equipment (not shown). The preferred embodiment shown in FIG. 1-A is illustrative but not intended to be limiting insofar as the scope of the invention is concerned. For example, the handle 23 is shown in a preferred and highly stylized embodiment, but any device which performs the functions of the handle as described below would suffice.
Articulating arm 20 comprises a plurality of �ball and socket� links. FIG. 1-B is a cross sectional view of a link used in the arm of the present invention. As seen, each link 120 has a hole 123 that passes through its center. Each link 120 comprises, on its distal end, a hemispherical protrusion 121; and on its proximal end, a hemispherical indentation 122. The hemispherical shapes of adjacent links are nearly identical, such that the links rotate smoothly against one another provided they are not under undue tension with each other.
Turning now to FIG. 1-C which is a partial view of a section of the links and cable showing the engagement of the cable with the side wall of the links as the arm is bent. A cable 40 passes through hole of all of the links and is connected between the handle 23 and the tightening/spreading mechanism 21. Rotation of handle 23 tightens the cable and causes the links to hold against each other in place. Immobilization of the links relative to each other during tightening of the cable is facilitated by the shape of the hole 123. As seen, hole is flared, having a larger opening with the surface of the hemispherical protrusion 121 and a smaller opening through the surface of the hemispherical indentation 122 The links, as seen in FIG. 1-A, vary in size along the length of the arm, with the links in the most proximal portion of the arm being largest, the links in the most proximal portion the smallest and the middle portion somewhere in between. In the preferred embodiment the links have the a following outer diameters and radius of curvature for the hemispherical protrusion and radius of curvature for the hemispherical indentation along each of these portions as follows:
Portion of arm
R1(inches)
R2(inches)
DIA(inches)
Most distal portion
Most proximal
The above dimensions are exemplary and other dimension may also be selected. In the preferred embodiment, the links are fabricated out of highly rigid engineered thermoplastics such as glass filled Ultem� (available from GE Plastics, Pittsfield, Mass.) Preferably the highly rigid engineered thermoplastics includes at least 20% glass fiber, and better still at least 30% glass fiber. This material offers stiffness comparable to metal systems, and yet can be manufactured at costs that allow for single use disposability. The cable is preferably a multi-stranded stainless steel cable having between approximately 7 to 19 strands. The links and cable may also be manufactured from other materials, including any other suitable highly engineered polymers including any number of available liquid crystal polymers for the links, as well as many other types of cables, including bundle stranded, braided or cabled titanium as well as Kevlar� for the cable.
The preferred embodiment also employs a textured surface molded or otherwise formed into the hemispherical features of the links. When the links are pulled together during tightening, the texturing causes an increase in coefficient of friction between the adjacent spherical surfaces. This has the highly desirable benefit of increasing overall system stiffness. This is depicted in FIG. 1-D which depicts the roughened surfaces between the ball and socket, such that in tension, the elements are more securely linked together. As seen, in the preferred embodiment, the texture provided is irregular, that is, the texture is non-uniform, and has an average height spanning approximately (peak to valley) of between 20 to 100 microns, with an average height (heightavg.) spanning approximately 40 microns preferred. As seen in FIG. 1-E, moreover, in an alternative embodiment texture may be provided through a symmetrical structure, depicted here as a series of interlocking dimples 127 and hemispheres 128. Other geometries may also be used, including both surface having the same elements, such as hemispheres, as well as other shapes, including notches or grooves, to name only a few.
In this embodiment, articulating arm links 120 have a decreasing outer diameter from the proximal portion to distal end portion of the arm. This is also seen in FIG. 1-A, where outer diameter of the most proximal link portion DMPL is larger is that the outer diameter of the middle link portion DMLP which, in turn, is larger is that the outer diameter of the most distal link portion DMDL. Decreasing the link diameter allows a lower profile assembly that improves the ability of the surgeon to use the device without unduly restricting accessibility to the surgical site while further ensuring adequate rigidity. In the preferred embodiment DMPL is approximately 0.75 inches, DMDL. is approximately 0.50 inches and the DMLP a outer diameter of approximately 0.625 inches, and the total arm length is approximately 10.25 inches with the pods and approximately 9 inches without the pods. Further, in the preferred embodiment most proximal link portion features 19 links, middle link portion features 4 links, and most distal link portion features 3 links.
FIG. 1-F is a view of the bottom of the suction pods 22. As seen, in the preferred embodiment four suction ports 133 in a row are featured, although the specific or exact number and position used may vary. Each suction port 133 has a suction aperture 132, each of which are preferably located at a position off-center from suction port 133. Suction apertures 132 are positioned off center from suction ports 133 so that if a large up welling of tissue is caused by the suction (which may occur as a blister or bell-shaped curve) the tissue will not immediately close off the suction by obstructing suction aperture 132, as it would if the aperture were in the center of suction port 133. In addition, each suction aperture 132 has a much smaller opening surface area diameter as compared to the diameter of suction port 133. This creates a high resistance pathway between suction port 133 and suction conduit 131 which permits the loss of a tissue-to-port seal in one suction port (and thus loss of fixation of the suction port to the tissue) to not also cause a precipitous pressure drop in the remainder of the suction ports. In the preferred embodiment suction port 133 has a diameter of 6 mm. while each suction aperture 132 has a opening surface area of approx 3 sq. mm. Each suction port, moreover, is generally straight sided. The above dimensions are exemplary and other dimension may also be selected.
Arm rigidity is further enhanced through the interplay between the multi-stranded cable riding on the inner diameter of the plastic segments. The multi-stranded cable riding on the inner diameter of the plastic segments induces additional friction which optimizes stability. As the cable is tensioned at high load values (>200 lb.), the cable digs into the inner diameter of the softer plastic of the segments. This is depicted above in regards to FIG. 1-C which is a partial view of a section of the links and cable showing the engagement of the cable with the side wall of the links as the arm is bent. Since the cable is striated with typically 7-19 strands, the result is a strong interlocking of cable and plastic segments. The interlocking of the stranded cable to the plastic segment increases the coefficient of friction between cable and plastic segment. This further locks up segments to each other since they cannot slide easily along the cable. Thus enhancing arm rigidity. Below sufficient cable tension, however, the cable does not dig into the links and cause the strong increase in coefficient of friction. Additional embodiments of the invention may also feature cables of greater surface roughness, as well as sheathing the cable in materials sheaths having a greater coefficient of friction than the cable itself. Such friction enhance sheaths are particularly believed useful where cables other than stranded cables are used, such as Kevlar� cables, as mentioned above.
Cable 40 terminates in tabbed element 13. Tensioning of the cable causes the tabbed element to move proximally, pulling back on sling 14. The sling wraps around the split ball 225 of pods, capturing the split ball. In its relaxed state, when the stainless cable is loose, relatively little friction exist between split ball 225, inner cavity of sling 14 and outer spherical surface of head link 12 so that split ball 225 is relatively able to be moved or rotated therein. In the preferred embodiment, the outside diameter of split ball is equal to the diameter of the spherical cavity defined within sling and head link, preferably these diameters are all approximately 0.193 inches. As the cable is tightened, however, the sling cinches down over the split ball compressing the split ball into the sling and head link 12. As the split ball 225 is compressed, the split 226 closes, causing suction pods 22 to splay angularly outward. In the hi preferred embodiment split ball 225 is made from non-glassed filled Ultem� (available from GE Plastics, Pittsfield, Mass.)
In a preferred embodiment, a compressible (preferably elastomeric) disk 15, is mounted between sling 14 and head link 12. The preferred material for disk 15 is silicone with a durometer of 80, although other materials or durometers or both may also be selected. Disk 15 preferably sits or mates into a compression limiter 41, depicted here as a stainless steel cup 41, which functions to limit the total amount to which the disk may be compressed. That is, disk 15 is sized to fit within cup so as to be able to be compressed an amount no greater than the depth of the cup. In the preferred embodiment, allowed to be compressed approximately no more than 0.040 inches. Of course, other sizes and material may also be selected. The identity, size, and other materials properties of the elastomeric disk 15 and cup (if used, for example, cup could be integrated into head link or cable tab) are chosen such that disk 15 it is crushed between head link 12 and sling 14 before the split ball is compressed. This causes articulating arm 20 to become fin before the spreading or other moving of the suction pods 22 begins, adding a desired degree of control to the system. Vacuum connections to suction pods 22 are made via barbed connections 325 at the proximal end of suction pods 22.
FIG. 8 is a perspective view of the third of three preferred embodiments for tightening/spreading mechanism 21. FIG. 9 is an exploded perspective view of the tightening components of FIG. 8. The embodiment of FIGS. 8 and 9 provides independent rotational spreading of i the suction pods (not shown in these two FIGS.) in any plane about a point of rotation at the center of the mechanism. When articulating arm 20 is loose, the suction pods 22 will move freely. Because the suction pods 22 are not linked together in this embodiment, they are able to conform to surfaces of the heart where the suction pods would not be co-planar. This provides more secure mounting of the suction pods on areas of the heart with small radii of surface curvature.
FIG. 10 depicts the relationship between rigidity of the articulating arm and the spreading apart of the suction pods 22 shown above in FIG. 1-A. As seen the present invention is designed so to provide a particular relationship between the rigidity of articulating arm and the spreading of suction pods. In the embodiment shown in FIGS. 6 & 7 the initial relationship between rigidity and spread is linear until a spreading point, seen here as Q, is reached. Thereafter a non-linear relationship is seen. In this embodiment there is thus a simultaneous change in the rigidity of the arm and the spreading of the pods.
FIGS. 11 & 12 depict the relationship of rigidity and spreadablity in a further embodiment of the present invention. As seen in this embodiment the articulating arm undergoes a transformation of rigidity from loose flexibility to form flexibility at time B1. Thereafter, at time B2 articulating arm undergoes a transformation of rigidity from firm to hard. Continuing tightening of the handle (which controls rigidity and spread in the embodiment shown in FIGS. 1-7) does not cause the arm to become appreciatively more rigid. In contrast, the spreadability of the suction pods is depicted in FIG. 12 and is seen, in particular, to occur at a lag from the transformation of rigidity. In particular, as seen at B1 the rigidity is increased from loose to firm while the spread of the suction pods does not occur until time C1 that is, turning of handle 23 to reduce the flexibility of the part of the articulating arm from loose to firm does not cause an appreciable spread until a time thereafter, here seen as C1 The particular relation between rigidity and spread may be selected to occur in any favorable matter. Practically speaking, the relationship between rigidity and spread may be a matter of choice which is best left to the surgeon. Thus, the present invention permits this relationship to be tailored as desired though the selection of among the following factors: in the present invention shown in FIG. 1-A and thereafter shown in particular regard in FIGS. 6 & 7, the relationship of rigidity and spread may be controlled through the particular design and selection of the arm links and texture, split ball and hinge, split ball and split or gap, washer and cup as well as any of their materials.
This is seen in FIGS. 13 through 21, which show the split ball 225 of the preferred embodiment (FIG. 13 through 16) and alternative designs. As seen FIG. 13 is a detailed perspective of split ball 225 shown assembled in a stabilization system. FIG. 14 is a plan view of the split ball 225 shown in FIG. 13 from an overhead position. This view shows the split or gap 226 within split ball and the hinge 227. The size of hinge 227 and split or gap 226 define the actuation of the pods mounted to the split ball and further the degree of force required. These elements, along with other elements of the present invention, may be tailored to provide the particular actuation and performance characteristics deemed suitable for a surgeon or surgeons. FIG. 15 is a cross sectional view of split ball 225 shown in FIG. 13 along line 15�15. In the preferred embodiment gap 226 has a minimum thickness T226 of between 0.010-0.100 inches, with 0.040 inches preferred, while hinge 227 has a thickness T227 of between 0.220-0.010 inches, with 0.110 inches preferred. FIG. 16 is a two dimensional plot of the gap along the outer surface of the split ball. As seen, in this embodiment, gap is symmetrical along the outer surface.
In a further embodiment of the present invention the segmented spreadable hinge 199 as well as spreadable hinge shown above in regards to FIGS. 6 & 7 may be provided such that the suction pods move in a non-parallel fashion. One embodiment of this non-parallel movement is shown in FIG. 23. As seen in a first, non-spread, orientation paddle 22L & 22R are disposed of first distance A apart. Once the spreading has been ignited through any of the various methods described above, paddles 22L & 22R reach the disposition of FIG. 24. As seen in this disposition the closes point the paddles have to one another is at their base or proximal positions and is at a distance A+X. The distal ends of the paddles are shown at a distance A+Y apart such that an angle faded exists between the longitude and the axis of each paddle. Embodiments which may be utilized to achieve such movement are those shown above. Likewise, FIG. 25 shows and additional embodiment in which the paddles start at a disposition where the distal ends are a distance B apart, and disposed at an angle alpha relative to one another. After movement paddles reach the disposition shown in FIG. 26, and are generally parallel to one another and are now at a distance B+Z apart. Embodiments which may be utilized to achieve such movement are those shown above. Likewise, FIG. 27 shows and additional embodiment in which the paddles start at a disposition where the paddles are a distance C apart. After movement paddles reach the disposition shown in either FIG. 28 or 29, and are generally angled at an angle beta relative to one another, having a distance at the distal end of either C+X or C+X2 and a proximal distance of either C or C+X1 Embodiments which may be utilized to achieve such movement are those shown above.
FIG. 30 depicts further alternative embodiment of the present invention. In this embodiment suction pods 22L & 22R may be spread and rotated such that they move from an orientation shown in FIG. 30, and have a distance A apart, to the orientation shown in FIG. 31. As seen in FIG. 31, at this point paddles 22L &22R are a minimal distance A+X1 apart at their proximal end an greater distance A+X2 apart at their distal end. Furthermore, the pods have had a relative rotation such that the bottom surface of the pods now define an angle sigma Such movement may be provided through, among other ways, the a split ball having a split which is non-symmetrical across the plane defined by the paddles, such as the split ball shown in FIG. 20.
FIG. 32 depicts a further alternative embodiment of the present invention. In particular, FIG. 32 is a sectional view across pod 22L shown in FIG. 22 along line O�O. As seen, in this embodiment, pod 22L features a suction port 33 open along the bottom surface of the suction pod. Suction port 33 further communicates with a suction aperture 31. In this embodiment the total height H of the pod is minimized because the suction aperture is located along side the suction port such that the aperture only exists at a point within the suction port no greater than the height of the suction port opening, that is the bottom of the suction port, depicted here as 33-b is relatively above, in this figure, suction aperture 34. H is between approximately 1 and 4 millimeters with 2-3 preferred.
FIGS. 38-40 depict an alternative embodiment of the present invention. As seen, suction pod 22 has a series of suction ports 33 as already described above. In this embodiment suction pod is made, however, from a malleable material such that the pod itself can be shaped by the surgeon prior to disposition of the pod onto the surface of the heart. It is believed that this malleability or conformability provides the surgeon with increased flexibility so as to shape the pod to be conformed into or around the surface of the particular area of the heart upon which he will operate. As seen malleable pod may further include a spring or other form of stiffening element or lockable member 190 which is still malleable to some degree. In the present invention this lockable member 190 would comprise a wound coiled spring, although other materials and devices may be used, including, but not limited to, straps, band, bands, interwoven metallic members, heat set plastics, to name some of other alternative materials and devices which may be used. In a first embodiment the malleable pod is constructed of PVC (poly vinyl chloride) 73 Shore A durometer and the lockable member is constructed from a hypotube made of MP35N metal alloy. In the preferred embodiment the hypotube used to carry suction to the suction ports and thus functions as a suction aperture. Alternately, the malleable pod formation permits the pod itself to be moved from its first orientation, as seen in FIG. 40 at 189 to the deformed position 188 shown at FIG. 40. Alternatively, pod may be manufactured from many other types of materials, including silicone rubber, polyurethane, to name only a few, while lockable member may be constructed form coiled conductors, polymeric strips, or strips or ribbons or springs made from nitinol.
The present invention may be especially suitable for performing a surgical operation on a patient utilizing the simultaneous spreading of the device′ paddles and the stiffening of the fixation arm. That is, this embodiment may permit use of the following method of performing a surgical procedure. First, the desired area of tissue is accessed, e.g. the heart and the coronary artery of interest is accessed. Next, a stabilization system is placed upon the surface of the tissue, e.g. a stabilization system as shown in FIGS. 1-3, 6-9 is placed upon the surface of the tissue, and in particular suction pods 22 is placed upon the surface of the tissue. Next, suction is introduced into each pod such that the surface of the tissue is captured by the first pod and the second pod. Next, the first pod and the second pod are caused to be spread relatively apart while the articulating arm 20 is concurrently caused to become stiff. In the illustrated embodiment of FIGS. 1-3 this may be accomplished by turning distal handle 23. As already described above, turning of distal handle causes tension to be applied to cable, causing in turn first paddle and second paddle to thereafter be spread relatively apart or otherwise moved (e.g. moved together, where the exact motion depends on the hinge design and the orientation of the pods or paddles) and also causing each of the links of the arm to be compressed together. The method may also be performed where the step of causing the articulating arm to become stiffer may be performed at either a time prior to or after the step of spreading relatively apart the first pod and the second pod. Thereafter a surgical procedure may be performed. Finally, the process is reversed and the patient is closed, as is well known in the art.
The particular embodiment shown in FIGS. 4 and 5 may be especially suitable for performing a surgical operation on a patient utilizing only the spreading aspect of the device′ paddles and not the stabilization through the stiffening of the fixation arm. That is, this embodiment may permit use of the following method of performing a surgical procedure. First, the desired area of tissue is accessed, e.g. the heart and the coronary artery of interest is accessed. Next, a stabilization system is placed upon the surface of the tissue, e.g. a stabilization system as shown in FIGS. 4 and 5 is placed upon the surface of the tissue, and in particular suction pods 22 is placed upon the surface of the tissue. Next, suction is introduced into each pod such that the surface of the tissue is captured by the first pod and the second pod. Next, the first pod and the second pod are caused to be spread relatively apart. In the illustrated embodiment this may be accomplished by turning wheel 5 to cause first paddle and second paddle to thereafter be spread relatively apart. Thereafter a surgical procedure may be performed. Finally, the process is reversed and the patient is closed, as is well known in the art. Thus this method does not require the use of a stiffened arm to provide for the further stabilization. Only the spreading of the paddles is used.
In a still further embodiment, shown here in FIG. 42, the bottom surface may feature a series of burrs or upraised barbs 656. These structures act as cleats which puncture or are introduced a small amount, between 0.25 to 1.5 millimeter beyond the surface of the tissue and into the tissue itself, more or less, and serve to enhance the friction or gripability between the tissue and the paddle. Moreover, still further, these structures may be made hollow and may be coupled to a dispensing reservoir containing drugs, agents or other desired medicinal substance (such as anti-clotting agents, clotting agents, steroids, antibiotics, growth factors, genetically acting agents or anti arrhythmic agents, to name only a few) so as to also be used to inject directly such substances into the tissue in the vicinity adjacent the surgical procedure, e.g. into the epicardium in the vicinity adjacent the anastomosis. Other than these features, all other aspects of this embodiment may be the same as shown already above.
FIG. 43 is a perspective view of an alternative embodiment for tightening/spreading mechanism 21. In this embodiment a series of spreadable wedges having a series of inclines which cooperate with a cable stop to provide a system wherein movement of the pos or paddles may be caused to occur concurrent with or following arm tightening. As seen cable stop 300 is positioned at the distal end of arm. Cable stop hold the distal end of cable, not seen in this FIG. Cable stop is generally a cube like structure, having a relatively sharp comer or edge which is disposed to ride along first inclined surface 303 or second inclined surface 305 of spreadable saddle 307. As seen first inclined surface 303 is disposed at a first angle on spreadable saddle while second inclined surface 305 is disposed at a second angle on spreadable saddle such that the first angle is relatively more flat or oblique in regards to the bottom surface of cable stop 300 when compared to the second angle. Through these inclines and their angular relation to the bottom surface and side edges of cable stop, the co-efficient of friction between the cable stop and the first inclined surface 303 and second inclined surface 305 will be different. In such a manner, a first tension to the cable will generally first cause the arm and its links to be pulled together, thereafter, once tension exceeds the required coefficient of friction and cable stop is moved to engage the second inclined surface will the spreadable saddle be caused to fully begin to spread. As can be seen, a hemispherical mounting 309 is disposed between saddle 307 and U-link 311 such that spreading of saddle pinches mounting and therefore causes movement of the attached pods or paddles (only one of which is depicted here in outline as 22.)
FIG. 45 is a still further embodiment of the present invention. In this embodiment all other features are the same as those described above in regards to FIG. I but for that the arm 420 is rigid, as opposed to the flexible arm shown above in FIG. 1. Rigid arm 420 may be used where the are in which the procedure is performed is extremely cramped. Arm 420, because it does not flex may have a much decreased diameter as compared to arm 20 (recall that the FIGS. Are not necessarily to scale.)
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