Source: http://www.google.com/patents/US6361519?dq=60/310,746
Timestamp: 2016-05-06 06:27:23
Document Index: 443432491

Matched Legal Cases: ['art.\n6', 'art.\n15', 'art.\n19', 'art.\n20', 'art.\n21', 'art.\n22', 'art.\n26', 'art.\n27', 'art.\n28', 'ART 2443', 'art 43', 'Art, 165', 'art 2443']

Patent US6361519 - Mesh tip myocardial implant - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsA method and apparatus for performing coronary artery bypass surgery establishes a channel leading directly from a chamber of a heart into a coronary artery. The coronary artery bypass procedure may be performed with or without cardiopulmonary bypass....http://www.google.com/patents/US6361519?utm_source=gb-gplus-sharePatent US6361519 - Mesh tip myocardial implantAdvanced Patent SearchPublication numberUS6361519 B1Publication typeGrantApplication numberUS 09/548,175Publication dateMar 26, 2002Filing dateApr 13, 2000Priority dateAug 13, 1996Fee statusLapsedAlso published asCA2262623A1, DE19735141A1, DE69717859D1, DE69717859T2, EP0959815A1, EP0959815B1, EP1312320A2, EP1312320A3, US5755682, US5944019, US6093166, US6123682, US6350248, US6454794, US6701932, US6913021, US6929011, US20020049486, US20020065478, US20020072699, US20030018379, US20040073157, US20040077990, US20040122347, US20050228334, US20060155239, WO1998006356A1Publication number09548175, 548175, US 6361519 B1, US 6361519B1, US-B1-6361519, US6361519 B1, US6361519B1InventorsMark B. Knudson, William L. GieseOriginal AssigneeHeartstent CorporationExport CitationBiBTeX, EndNote, RefManPatent Citations (62), Non-Patent Citations (61), Referenced by (87), Classifications (52), Legal Events (8) External Links: USPTO, USPTO Assignment, EspacenetMesh tip myocardial implant
US 6361519 B1Abstract
What is claimed is: 1. An apparatus for use in a coronary artery bypass procedure at a coronary vessel disposed lying at an exterior of a heart wall, the apparatus comprising;
a hollows blood flow conduit having a first end sized for being inserted into and retained within the cart wall of a heart chamber containing oxygenated blood with said first end sized to span a thickness of the heart wall with an opening of the first end in blood-flow communication with blood contained within the chamber, said first end having sufficient radial rigidity to resist collapse of said first end in response to contraction of said heart; the conduit having a second end sized for being inserted within the coronary vessel with an opening of the second end in blood flow communication with a lumen of the coronary vessel, said second end having an open cell structure within said vessel; and the conduit defining a blood flow path between the openings of the first and second ends. 2. An apparatus according to claim 1 wherein the conduit is a substantially L-shaped tube.
3. An apparatus according to claim 1 wherein the conduit is a substantially T-shaped tube.
4. An apparatus according to claim 1, wherein the first end of the conduit protrudes beyond an interior surface of the heart wall.
5. An apparatus according to claim 1 wherein the blood flow path closes at least once during a cycle of the heart.
6. An apparatus according to claim 5 wherein the conduit includes a valve to close during diastole.
7. An apparatus according to claim 1 wherein the second end is radially expandable within the vessel.
8. An apparatus according to claim 7 wherein the first end is radially expandable within the heart wall.
9. An apparatus for use in a coronary artery bypass procedure at a coronary vessel disposed lying at an exterior of a heart wall, the apparatus comprising;
a hollow blood flow conduit having a first end sized for being inserted into and retained within the heart wall of a heart chamber containing oxygenated blood with said first end sized to span a thickness of the heart wall with an opening of the first end in blood flow communication with blood contained within the chamber, said firs end having sufficient radial rigidity to resist collapse of said first end in response to contraction of said heart; the conduit having a second end sized for being inserted within the coronary vessel with an opening of the second end in blood flow communication with a lumen of the coronary vessel, said second end having an open cell structure within said vessel; and the conduit defining a blood flow path between the openings of the first and second ends, wherein the conduit includes a reservoir for accumulating blood from the conduit during periods of high blood pressure and for discharging accumulated blood into the conduit during periods of low blood pressure. 10. An apparatus according to claim 9, wherein the first end of the conduit protrudes beyond an interior surface of the heart wall.
11. A method for performing a coronary bypass procedure at a coronary vessel disposed lying on an exterior of a heart wall of a having a heart having a heart chamber, the method comprising:
A. selecting a hollow blood flow conduit having: a. a first end sized for being inserted into and retained within the heart wall of a heart chamber containing oxyenated blood with an opening of the first end in blood-flow communication with blood contained within the chamber; b. the conduit having a second end sized for being inserted into the coronary vessel with an opening of the second end in blood flow communication with a lumen of the coronary vessel, said second end having an open cell structure within said vessel; and c. the conduit defining a blood flow path between the openings of the first and second ends, B. inserting the first end of the conduit through the heart wall with the first end in blood flow communication with the heart chamber; C. placing the second end of the conduit into the vessel with openings of the open cell structure opposing an interior wall of the vessel. 12. A method according to claim 11 wherein the blood flow path is formed by placing the conduit through a deep wall of the coronary vessel.
13. A method according to claim 11 wherein the coronary vessel is a coronary artery.
14. A method according to claim 11 comprising closing the blood flow path once per cycle of the heart.
15. A method according to claim 11 wherein the blood flow path is closed during diastole.
16. A method according to claim 11 Wherein the second end is radially expanded within the vessel.
17. A method according to claim 16 wherein the first end is radially expanded within the heart wall.
18. The method of claim 11, wherein the heart is a human heart.
19. The method of claim 11, wherein the conduit remains in the heart.
20. The method of claim 11 further comprising the steps of: closing an incision made during insertion of the conduit and leaving the conduit in the heart.
21. The method of claim 11 further comprising the steps of: withdrawing a catheter used to deliver the conduit and leaving the conduit in the heart.
22. An apparatus for use in a coronary artery bypass procedure at a coronary vessel disposed lying at an exterior of a heart wall, the apparatus comprising;
a blood flow conduit having a first end sized for being inserted into and retained within the heart wall of a heart chamber containing oxygenated blood with said first end sized to span a thickness of the heart wall with an opening of the first end in blood-flow communication with blood contained within the chamber, said first end having a solid wall construction within said heart wall and sufficient radial rigidity to resist collapse of said first end in response to contraction of said heart; the conduit having a second end sized for being inserted within the coronary vessel with an openig of the second end in blood flow communication with a lumen of the coronary vessel, said second end having an open cell structure within said vessel; and tile conduit defining a blood flow path between the openings of the first and second ends. 23. An apparatus according to claim 22, wherein the first end of the conduit protrudes beyond an interior surface of the heart wall.
24. A method for performing a coronary bypass procedure at a coronary vessel disposed lying on an exterior of a heart wall of a heart having a heart chamber, the method comprising:
A. selecting a hollow blood flow conduit having: a. a first end adapted to be inserted into and retained within the heart wall of a heart chamber containing oxygenated blood with an opening of the first end in blood flow communication with blood contained within the chamber, said first end having a sufficient radial rigidity to resist collapse of said first end in response to contraction of said heart, wherein said first end remains open during both systole and diastole; b. the conduit having a second end sized to be inserted into the coronary vessel with an opening of the second end in blood flow communication with a lumen of the coronary vessel, said second end having an open cell structure within said vessel; and c. the conduit defining a blood flow path between the openings of the first and second ends; B. inserting the first end of the conduit through the heart wall with the first end in blood flow communication with the heart chamber; C. placing the second end of the conduit into the vessel with openings of the open cell structure opposing an interior wall of the vessel. 25. The method of claim 24, wherein the heart is a human heart.
26. The method of claim 24, wherein the conduit remains in the heart.
27. The method of claim 24 further comprising the steps of closing an incision made during insertion of the conduit and leaving the conduit in the heart.
28. The method of claim 24 further comprising the steps of: withdrawing a catheter used to deliver the conduit and leaving the conduit in the heart.
The present application is a continuation of U.S. patent application Ser. No. 09/055,488, filed Apr. 3, 1998, entitled CORONARY BYPASS IMPLANT now U.S. Pat. No. 6,093,166 and filed in the name of the same inventors as the present application, which is also a continuation of U.S. patent application Ser. No. 08/689,773, filed Aug. 13, 1996, entitled METHOD AND APPARATUS FOR PERFORMING CORONARY ARTERY BYPASS SURGERY, now U.S. Pat. No. 5,755,682 and filed in the name of the same inventors as the present application.
Arteriosclerosis is “a group of diseases characterized by thickening and loss of elasticity of arterial walls.” DORLAND'S ILLUSTRATED MEDICAL DICTIONARY 137 (27th ed. 1988). Arteriosclerosis “comprises three distinct forms: atherosclerosis, Monckeberg's arteriosclerosis, and arteriosclerosis.” Id.
The re-opening of the stenosed or occluded site can be accomplished by several techniques. Angioplasty, the expansion of areas of narrowing of a blood vessel, is most often accomplished by the intravascular introduction of a balloon-equipped catheter. Inflation of the balloon causes mechanical compression of the arteriosclerotic plaque against the vessel wall. Alternative intravascular procedures to relieve vessel occlusion include atherectomy, which results in the physical desolution of plaque by a catheter equipped (e.g. a cutting blade or high-speed rotating tip). Any of these techniques may or may not be followed by the placement of mechanical support and called a “stent,” which physically holds the artery open.
Depending upon the degree and number of coronary vessel occlusions, a single, double, triple, or even greater number of bypass procedures may be necessary. Often each bypass is accomplished by the surgical formation of a seperate conduit from the aorta to the stenosed or obstructed coronary artery, at a location distal to the diseased site. A major obstacle has been the limited number of vessels that are available to serve as conduits. Potential conduits include the two saphenous veins of the lower extremities, the two internal thoracic arteries under the sternum, and the single gastroepiploic artery in the upper abdomen. Theoretically, if all of these vessels were utilized, the procedure would be limited to a quintuple (5-vessel) bypass. Because of this, newer procedures using a single vessel to bypass multiple sites have evolved. However, this technique is fraught with its own inherent hazards, though. When a single vessel is used to perform multiple bypasses, physical stress(e.g., torsion) on the conduit vessel can result. Such torsion is particularly detrimental when this vessel is an artery.
While experimental procedures transplanting alternative vessels continue to be performed, in general clinical practice there are five vessels available to use in this procedure over the life of a particular patient. Once these “spare” vessels have been sacrificed, there is little or nothing that modern medicine can offer. It is unquestionable that new methods, not limited by the availability of such conduit vessels, are needed.
In the past, the normal contractions of the heart have usually been stopped during suturing of the bypass vasculature. This can be accomplished by either electrical stimulation which induces ventricular fibrillation, or through the use of certain solutions, called cardioplegia, which chemically alter the electrolytic milleau surrounding cardiac muscles. Stoppage of the heart enhances visualization of the coronary vessels, while removing the need for blood flow through the coronary arteries during the procedure. This provides the surgeon with a “dry field” in which to operate and create a functional anastomosis. After the coronary artery bypass procedure is completed, cardioplegia is reversed, and the heart electrically stimulated if necessary. As the heart resumes the systemic pumping of blood, the cardiopulmonary bypass is gradually withdrawn. The seperated sternal sections are then re-joined, and the overlying skin and saphenous donor site or sites (if opened) are sutured closed.
The conventional surgical procedures (such as those described above) for coronary artery bypass grafting using saphenous vein or internal thoracic artery via an open-chest approach have been described and illustrated in detail. See generally Stuart W. Jamieson, Aortocoronary Saphenous Vein Bypass Grafting, in ROB & S MITH's OPERATIVE SURGERY: CARDIAC SURGERY, 454-470 (Stuart W. Jamieson & Norman E. Shumway eds., 4th ed. 1986); LUDWIG K. VON SEGESSER, ARTERIAL GRAFTING FOR MYOCARDIAL REVASCULARIZATION: INDICATIONS, SURGICAL TECHNIQUES AND RESULTS 48-80 (1990). Conventional cardiopulmonary bypass techniques are outlined in Mark W. Connolly & Robert A. Guyton, Cardiopulmonary Bypass Techniques, in HURST's THE HEART 2443-450 (Robert C. Schlant & R. Wayne Alexander eds., 8th ed. 1994). Coronary artery bypass grafting, utilizing open-chest techniques but without cardiopulmonary bypass, is described in Enio Buffolo et al., Coronary Artery Bypass Grafting Without Cardiopulmonary Bypass, 61 ANN. THORAC. SURG. 63-66 (1996).
Methods of catheterization of the coronary vasculature, techniques utilized in the performance of angioplasty and atherectomy, and the variety of stents in current clinical have been described and illustrated. See generally Bruce F. Waller & Cass A. Pinkerton, The Pathology of Interventional Coronary Artery Techniques and Devices, in 1 TOPOL's TEXTBOOK OF INTERACTIONAL CARDIOLOGY 449-476 (Eric J. Topol ed., 2nd ed. 1994) ; see also David W. M. Muller & Eric J. Topol, Overview of Coronary Athrectomy, in 1 TOPOL's TEXTBOOK OF INTERVENTIONAL CARDIOLOGY at 678-684; see also Ulrich Sigwart, An Overview of Intravascular Stents: Old & New, in 2 TOPOL's TEXTBOOK OF INTERVENTIONAL CARDIOLOGY at 803-815.
With regard to the specification and claims of this application, the phrase “reduce reaction” is meant to indicate a reduction in tissue responses. This is meant to include, but not to be limited to, immune reactions, tissue scarring, blood clotting, and the like. The literature is replete with pharmaceuticals which can be either locally or systemically administered and which decrease the immune response to foreign bodies. These include corticosteroids, and the like. It is also well known in the literature that there are pharmaceutical agents which reduce scar tissue formation following injury. Newer published techniques to reduce re-stenosis in transplanted artificial vessels include coating such devices with non-immunogenic endothelial cells or fibroblasts. A common problem with transplanted vessels is blood clotting, and agents which reduce such clotting have been widely reported.
The phrase “reduce reaction” is also meant to indicate a reduction in the changes in arterial walls associated with the family of diseases known as arteriosclerosis. Arteriosclerosis is the most common cause of coronary artery occlusion and/or narrowing. Pharmaceutical agents which inhibit the formation of arteriosclerotic plaques have been discovered. Coating the device with agents which decrease the accumulation of such deposits can be beneficial in the prevention of re-stenosis.
With initial reference to FIGS. 2A, 2B, 2C, 2D and 2E, an embodiment of an apparatus according to the present invention is shown as a T-shaped stent 10. The stent 10 is hollow, and includes two axially-aligned intracoronary arms 14, 16 terminating at open ends 14 a, 16 a. An anchor arm 12 (having an open end 12 a) extends perpendicularly to arms 14, 16. The entire stent 10 is hollow to define a blood flow conduit 11 providing blood flow communication between open ends 12 a, 14 a and 16 a. As will be more fully discussed, arms 14 and 16 are adapted to be placed and retained within a lumen of a coronary artery on a downstream side of an occlusion with open ends 14 a, 16 a in blood flow communication with the lumen. The anchor arm 12 is adapted to extend through and be retained in a heart wall (e.g., a wall of the left ventricle) with the open end 12 a in blood flow communication with blood within the chamber. Accordingly, when so placed, the stent 10 defines a surgically-placed conduit establishing direct blood flow from the heart chamber to the artery. By “direct” it is meant that the blood flow does not pass through the aorta as occurs in traditional bypass procedures.
FIG. 2B illustrates use of an optional check valve 22 within the stent 10 and positioned in anchor arm 12. Check valves are well known and valve 22 permits flow only in the direction of arrow A (i.e., from open end 12 a to open ends 14 a, 16 a) while blocking reverse flow. Valve 22 is used to prevent the back-flow of blood from the coronary artery to the heart chamber. Valves sufficiently small to fit into arm 20 are within the skill of the art. For example, Wanpen Vongpatanasin et. al, Prosthetic Heart Valves, 335(6) N.E.J.M. 407-416 (Aug. 8, 1996) describes valves of 24 square millimeters.
FIG. 2C illustrates the use of check valve 22 as well as a second check valve 26 in arm 16 near the open end 16 a of the apparatus. The second check valve 26 permits blood flow only in the direction of arrow B. Valve 26 is used to prevent the back flow of blood in an upstream diretion within the coronary artery. For example, the coronary artery may not be completely obstructed and may have a reduced flow past an obstruction. The use of the T-stent 10 with axially alligned arms 14, 16 takes advantage of such reduced flow and supplements such flow with blood through anchor arm 12. As will be described, the stent 10 is placed with the arms 14, 16 in the lumen of the artery with opening 16 a positioned on the upstream side (i.e., nearest to, but still downstream of, the obstruction). Thus, valve 26 permits the utilization of normal blood flow while blocking back-flow.
While a T-shaped stent 10 is presently anticipated as most desirable, an L-shaped stent 10′ (FIGS. 1A, 1B, 1C) may be used to completely bypass the coronary obstruction. An L-shaped stent 10′ has an anchor arm 12′ with an open end 12 a′. Unlike stent 10, stent 10′ has only one intracoronary arm 14′ perpendicular to arm 12′. Arm 14′ has an open end 14 a′ and stent 10′ is hollow to define a continuous fluid pathway or conduit 11′ from end 12 a′ to end 14 a′. In application, arm 14′ is placed within the lumen of an artery. End 14 a′ faces downstream from an obstruction. Arm 12′ is placed through the heart wall with end 12 a′ in fluid communication with blood within the heart chamber. As illustrated in FIG. 1B, the anchor arm 12′ can include a check valve 22′ similar to valve 22 of stent 10.
Stent 10, 10′ may be rigid, or have varying flexibilities. FIGS. 3A , 3B and 3C demonstrate one embodiment where the anchor arm (i.e., elements 12, 12′ of FIGS. 1A and 2A) is comprised of a number of rings 17 surrounded by a membrane 18. In FIGS. 3A-3C, only anchor arm 20 is shown. It will be appreciated that anchor arm 20′ may be identically constructed. In the embodiment of FIGS. 3A-3C, the rings 17 can be constructed of teflon, and the surrounding membrane 18 can be constructed of a double-walled dacron sheath into which the teflon rings 17 are sewn. In this embodiment, the rings 17 provide structural strength. The structural strength maintains an open lumen or conduit 11 leading into the coronary artery by preventing the conduit 11 from collapsing by reason of contraction of the heart muscle surrounding the anchor arm 12. The series of rings 17 provide a degree of flexibility which allows a channel formed through the heart chamber muscular wall (receiving anchor arm 12) to be angled or curved. In addition, the flexability of the surrounding sheath 18 in concert with the rigid rings 17 will allow the anchor arm 12 to expand, FIG. 3B, and contract, FIG. 3C, with the contractions and relaxations of the surrounding cardiac musculature.
The apparatus of the present invention (as thus described) provides a path 11 through which blood flows from a chamber of a heart and into a coronary artery. Additionally, such a device can store blood under pressure for a period of time prior to its introduction into a coronary artery. As depicted in the embodiments of FIGS. 1C and 2D, this aspect of the apparatus 10, 10′ of the present invention is referred to as a capacitance pressure reservoir (CPR) 24, 24′.
The pressure gradient across the lumens 12 a, 12 a′, 14 a′, 16 a of the apparatus 10, 10′ of the present invention will vary over the cardiac cycle. For example, during systole, the contraction of the heart muscles will generate high relative pressures within the left ventricle. The pressures within the coronary arterioles and capillaries distal to the bypass site are also high during this time, due to the external compression of the contracting cardiac musculature surrounding these vessels. This is particularly true for the vessels of the microcirculation deep within the heart which serve the endocardium. The optional CPR 24, 24′ stores the pressurized blood during systole for delivery to the heart muscles via the coronary circulation during diastole when pressures are reduced. In essence, the CPR 24, 24′ serves a function similar to the elastic connective tissue of the thick-walled aorta. The necessary function of the CPR 24, 24′ is to store blood under higher pressure, and to later provide that stored blood to the microcirculation when the external pressures on that microcirculation are reduced.
As depicted in FIGS. 1C and 2D the check valves 22, 22′ n limits blood flow in the direction of A, which is from a chamber of a heart into the apparatus 10, 10′ via the lumen 11, 11′. The pressure on the blood within the chamber of a heart will be greatest when the surrounding cardiac musculature is in the contracting phase of the cardiac cycle. Because it is during this phase of the cardiac cycle that the external pressure on the coronary artery microcirculation is also highest, blood flow through the lumen 11, 11′ of the apparatus 10, 10′ could be limited. To counteract this tendency, the device 10, 10′ is equipped with a reservoir 24, 24′ which stores this pressurized blood flowing from a chamber of the heart during the cardiac contraction.
The reservoir, or CPR 24, 24′ is schematically illustrated in FIGS. 1C, 2D. It can be appreciated that the stent 10, 10′ is provided with a fluid passage 28, 28′ in communication with conduit 11, 11′. The passage 28, 28′ communicates with an expandable volume (or storage chamber) 27, 27′ defined by a movable wall 31, 31′ contained within a fixed housing 33, 33′. Springs 29, 29′ between wall 31, 31′ and housing 33, 33′ urge the wall 31, 31′ to move to reduce the size of volume 27, 27′. The springs 29, 29′ are pre-loaded to exert a force on wall 31, 31′ n less than a force exerted by blood within volume 27, 27′ during the contraction phase of the cardiac cycle, but greater than the force exerted by blood within volume 27, 27′ during the relaxation phase of the cardiac cycle.
The apparatus 10, 10′ is constructed in a manner which allows blood to flow into the storage chamber 27, 27′ of the apparatus 10, 10′ through the lumen 11, 11′ of arm 28, 28′ of the apparatus when the cardiac musculature is contracting. When blood is flowing into the storage chamber 27, 27′, the kinetic energy of the flowing blood is converted to potential energy, and stored in 29, 29′. During the relaxation phase of the cardiac musculature, the potential energy stored in 29, 29′ of the CPR 24, 24′ is then re-converted to kinetic energy in the form of blood flow out of the storage chamber 27, 27′ of the apparatus 10, 10′ via the lumen 11, 11′ of arm 28, 28′ of the apparatus.
While the CPR 24, 24′ is illustrated with a movable wall 31, 31′ and springs 29, 29′ to define a variable volume, other designs can be used. For example, the CPR 24, 24′ can be a balloon-like structure. As it fills with blood, the pressure on that blood increases through the stretching of an elastic component of a balloon. In another embodiment, the CPR, 24, 24′, can be a hollow bag, made of a material which is inelastic, but impermeable to liquids, and pliable similar to a plastic bag. When the heart contracts, blood is forced through lumen 11, 11′ n of arm 28, 28′ of the apparatus 10, 10′ of the invention into the collection bag. In this embodiment, the CPR, 24, 24′, is physically located in the potential space existing between the fibrous and serous layers of the pericardium. When the heart expands during the relaxation phase of the cardiac cycle, the increasing heart size within the fixed pericardial sac results in increasing external pressure on this collection bag. This increasing external pressure would then force blood to flow from the collection bag and back through the lumen 11′ 11′ of arm 28, 28′ of the device 10, 10′. The incorporation of a check valve 22, 22′ within the anchoring arm 12, 12′ of the device 10, 10′ would limit the flow of blood out of the device during diastole to the coronary artery via the lumen 11′ 11′ of arms 14 a, 14 a′, 16 a of the device, of the apparatus 10, 10′. Similarly, the incorporation of the check valve 26 within the intracoronary arm 16 of the T-shaped apparatus 10, when employed with the check valve 22 within the anchor arm 20 of the device 10, would limit the flow of blood out of the device during diastole to the portion of the coronary artery distal to the bypass site via the downstream lumen 11 of arm 14 a. The inner and outer cross-sectional diameters of a coronary artery decreases with the distance from the arterial origin. Eventually, the artery branches into a number of arterioles, which feed the capillary bed of the coronary arterial microcirculation.
The typical diameter of a lumen of a coronary artery is, in general, species specific; increasing with heart size. In humans, this lumen diameter is dependent upon which artery is being evaluated, but usually ranges from 2.5 to 4 mm in diameter, and decreases with distance from the aortic origin. In the preferred embodiment, the cross-sectional outer diameter of the intracoronary arms 14, 14′, 16 of the device of the present invention should effectively approximate the diameter of the lumen of the coronary artery being bypassed, at the bypass site. This allows the complete re-approximation of the previously opened superficial wall of the coronary artery during surgical closure, without high suture or staple tension resulting. In the most preferred embodiment, the outer diameter of the intracoronary arms 14, 14′, 16 of the device 10, 10′ of the present invention is equal to the diameter of the lumen of the coronary artery which is being bypassed, at the bypass location. When a CPR is placed, the artery wall may need to be expanded by the addition of a patch, such as dacron, well known in the art.
Also, due to smooth muscle relaxation and secondary vascular dilitation, the cross-sectional diameter of a lumen of a coronary artery will increase with the oxygen demand of cardiac muscle during times of stress. The cross-sectional inner diameter of the intracoronary arms 14, 14′, 16 of the device 10, 10′ of the present invention should effectively approximate that diameter necessary to provide adequate blood flow through the downstream lumen of the device 14 a, 14 a′ to effectively oxygenate the cardiac musculature normally supplied by the microcirculation of the coronary artery. In the preferred embodiment, the cross-sectional inner diameter of the intracoronary arms 14, 14′, 16 of the device 10, 10′ of the present invention should effectively approximate that diameter necessary to provide adequate blood flow through the lumen of the device to effectively oxygenate the cardiac musculature normally supplied by the microcirculation of the coronary artery during both times of cardiovascular resting and stress.
Prior to bypass surgery, an initial approximation of the required cross-sectional outer diameter of the intracoronary arms 14, 14′, 16 of the apparatus 10, 10′ of the present invention can be gained by standard radiographic techniques. Also, prior to bypass surgery, the appropriate opening pressure of a check valve 22, 22′ of the apparatus 10, 10′ of the present invention can be determined by the dynamic measurements of coronary artery pressure, blood flow, and heart chamber pressures through selective catheterization with standard techniques. See Minoru Hongo et al., 127(3) AM. HEART J. 545-51 (March. 1994).
During the coronary artery bypass procedure, the most appropriate sizing of the intracoronary arms 14, 14′, 16 of the device 10, 10′ of the present invention can be re-assessed. This can be accomplished by probing the distal and proximal aspects of the coronary artery at the chosen bypass site with blunt instruments of known outer diameters. Such sizing by probes is well-known in the literature. To facilitate the effective matching of the external diameter of the intracoronary arms 14, 14′, 16 of the device 10, 10′ of the present invention to the lumen 34 of the coronary artery to be bypassed, an assortment of devices of the present invention of various diameters can be available for the surgeon to select from.
General preparations for open-chest surgery in which cardiopulmonary bypass is not utilized have been published by Buffolo et al.,61 ANN. THORAC. SURG. 63-66 (1996). In one embodiment of the methods of the invention where an open-chest procedure without cardiopulmonary bypass is utilized, the patient can be prepared for surgery as outlined by Buffolo.
Buffolo et al. has reported an open-chest approach to the coronary arterial vasculature when performed without cardiopulmonary bypass. See Buffolo et al.,61 ANN. THORAC. SURG. 63-66 (1996). In one embodiment utilizing an open-chest approach without cardiopulmonary bypass, access to the coronary vasculature can be obtained as reported by Buffolo.
Through the methods of the present invention, the device 10, 10′ of the present invention, which provides blood from a chamber of a heart 43 directly into a coronary artery 30, is placed. To illustrate the invention, only placement of stent 10 is discussed. It will be appreciated that stent 10′ can be similarly placed. In addition, examples will be limited to the embodiment of the apparatus of the invention as illustrated in FIG. 2A.
Second, cardiopulmonary bypass is initiated by a variety of standard techniques as outlined by George Silvay et al., Cardiopulmonary Bypass for Adult patients: A Survey of Equipment and Techniques, 9(4) J. CARDIOTMORAC. VASC. ANESTH. 420-24 (August 1995).
Seventh, as shown in FIG. 5, the superficial wall 36 of the coronary artery 30 is longitudinally incised by standard techniques, such as incision with a scalpel, electrosurgical cutting device, or similar tool; taking care not to damage the deep wall of the artery. This initial incision can be lengthened, if necessary, to accommodate the intracoronary arms 14, 14′, 16 of the device 10, 10′, using standard tools such as fine angled scissors.
Tenth, through palpation, inspection, and probing of the distal and proximal coronary artery lumen 48, a device 10, 10′, of the present invention of appropriate dimensions is selected, as outlined above.
Eleventh, as illustrated in FIGS. 7 and 8, the anchor arm 12, 12′ of the apparatus of the present invention 10, 10′ is inserted into the formed channel 50. The one or two remaining arms 14, 14′, 16 of the device 10, 10′ are then seated within the lumen 48 of the coronary artery 30.
A closed chest approach according to the method of the present invention may use the stent 10, 10′ as described above. Such a procedure will now be described. Following this description, a closed chest approach using alternative embodiments of the apparatus of the invention will be described.
Seventh, in situations where the coronary artery can be directly viewed, the lumen 48 of the coronary artery is identified by palpation. Either under direct visualization, or under thoracoscopic guidance and using instruments manipulated through the trocar sheaths, the superficial wall 36 of the coronary artery is then longitudinally opened. As above, care is taken to leave the deep wall 40 of the artery undamaged. The incision 38 can be enlarged, as necessary, to accommodate the intracoronary arms 14, 14′, 16 of the device 10, 10′ of the present invention using fine angled scissors. This enlargement can be performed with standard surgical scissors under direct viewing through the window, or via other surgical instruments remotely manipulated following their insertion through the trocar sheaths.
Tenth, through direct and/or thoracoscopic inspection of the coronary artery lumen 48, or by probing as outlined above, an appropriately dimensioned device 10, 10′ of the present invention is selected. As in the case of the open-chest approach (outlined above), an array of devices 10, 10′ of various sizes can be available for the operation.
Eleventh, either under direct control and visualization, or by indirect manipulation and thoracoscopic viewing, the anchoring arm 12, 12′ of the apparatus 10, 10′ of the invention is inserted into the formed channel 50. By similar techniques the remaining intracoronary arm or arms 14, 14′, 16 of the apparatus 10, 10′ n are seated within the lumen 48 of the coronary artery 30 being bypassed. In one embodiment where the procedure is performed under thoracoscopic viewing, the device 10, 10′ can be introduced into the cardiac cavity through the space or window previously formed within the anterior inferior aspect of the left chest wall. In this embodiment, the device 10, 10′ can be grasped, once introduced into the chest cavity, by surgical instruments inserted through the trocar sheaths and remotely manipulated into position. In this manner the anchor arm 12, 12′ of the device 10, 10′ is then inserted into the channel formed 50 via the remote manipulation of these instruments.
Thirteenth, upon completion of placement of the device 10, 10′ of the present invention, the heart, if rotated, can be returned to its normal orientation.
The stent forming device 61 is a spiral sheet shown seperately in FIGS. 15A and 15B. Initially, the device 61 is a sheet formed in a spiral shape as shown in FIG. 15A to present a reduced diameter smaller than the diameter of the formed channel 50. In response to expanding forces (e.g., expansion of a balloon 60 within device 61), device 61 expands to a cylinder as shown in FIG. 15B. Interlocking tabs 61 a and recesses 61 b on opposing edges of the device 61 define a locking mechanism 62 to retain the device 61 in a cylindrical shape. The cylindrical shape of device 61 after expansion of the balloon 60, as shown in FIG. 15B, is larger in diameter than the spiral shape of device 61 prior to expansion of the balloon 60, as shown in FIG. 15A. The device 61 as expanded is sized to be retained within the formed channel 50 upon expansion.
This.third intraventricular catheter 70 is equipped with a hollow tube 71 on its distal tip which can interlock to the device 61 previously placed within the formed channel 50, as shown in FIGS. 17A and 17B.
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A61F2/07, A61B17/12P7, A61B17/12P1T2, A61F2/06, A61F2/90, A61F2/856, A61F2/06C, A61B17/11Legal EventsDateCodeEventDescriptionMar 18, 2003CCCertificate of correctionJan 28, 2004ASAssignmentOwner name: PERCARDIA, INC., NEW HAMPSHIREFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:HEARTSTENT CORPORATION;REEL/FRAME:014926/0339Effective date: 20031024Sep 26, 2005FPAYFee paymentYear of fee payment: 4Oct 3, 2006ASAssignmentOwner name: HORIZON TECHNOLOGY FUNDING COMPANY LLC, CONNECTICUFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:PERCARDIA, INC.;REEL/FRAME:018375/0912Effective date: 20060701Apr 29, 2008ASAssignmentOwner name: WILK PATENT DEVELOPMENT CORPORATION, NEW YORKFree format text: ASSET PURCHASE AGREEMENT;ASSIGNOR:PERCARDIA, INC.;REEL/FRAME:020876/0587Effective date: 20070116Nov 2, 2009REMIMaintenance fee reminder mailedMar 26, 2010LAPSLapse for failure to pay maintenance feesMay 18, 2010FPExpired due to failure to pay maintenance feeEffective date: 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