Source: https://patents.google.com/patent/US6959711B2/en
Timestamp: 2019-04-26 16:51:52+00:00

Document:
2004-12-02 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=26955284&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US6959711(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
This application is a continuation of U.S. patent application Ser. No. 09/864,794 entitled “Kit and Method for Use During Ventricular Restoration” filed on May 24, 2001, now U.S. Pat. No. 6,681,773, which claims the benefit of U.S. Provisional Patent Application Ser. No. 60/272,073 filed on Feb. 28, 2001.
The amount of blood pumped from the left ventricle divided by the amount of blood available to be pumped is referred to as the ejection fraction of the heart. Generally, a healthier heart has a higher ejection fraction. A normal heart, for example may have a total volume of one hundred milliliters and an ejection fraction of 60 percent. Under these circumstances, 60 milliliters of blood are pumped with each beat of the heart. It is this volume in the normal heart of this example that is pumped with each beat to provide nutrients including oxygen to the muscles and other tissues of the body.
Turning to FIG. 1, there is presented an overview method 100 for performing and using one embodiment of the present invention. A more complete discussion of this method will be presented below. The method 100 may use the following components: a shaping device 200 (FIG. 2 a), a patch 300 (FIG. 3 a), a sizer 402 a (FIG. 4 a), and a suture hook 520 (FIG. 5). Referring back to FIG. 1, at step 102, a surgeon determines the appropriate size for the patient's left ventricle based on the patient's height, weight, body surface area and other patient specific conditions. Once the patient's appropriate ventricle size has been determined, at step 104, the surgeon can then select the appropriate volume for the shaping device 200. At step 106, the surgeon opens up the chest cavity in a conventional manner. An incision is cut into the myocardial wall of an enlarged heart in step 108. At step 110, the surgeon identifies non-viable tissue. At step 112, the surgeon may remove all or some of the non-viable tissue (i.e., the dyskinetic and akinetic areas) of the myocardium. A continuous round stitch, known in the art as a Fontan stitch, may then be woven into the ventricle, at step 114. The stitch produces an annular protrusion, which forms an opening. At step 116, the shaping device 200 may be inserted into the ventricle through this opening. At step 118, the musculature of the myocardium may be pulled over the shaping device to form a left ventricle having a predetermined volume, shape and contour. The shaping device 200 may then be compressed and removed at step 120. At step 122, with the aid of the sizer 402 a, the surgeon may determine the preferred location of and size of the patch 300 which may be placed in the left ventricle. The patch 300 is then cut to size in step 124 and secured to the inside of the myocardium in step 126. At step 128, with the patch 300 suitably placed, the ventricle is closed by joining the myocardial walls over the patch.
In some embodiments, such as illustrated in FIG. 2 b, the shaping device may be an inflatable balloon 201, having a thickness of in the range of 0.02 to 0.08 inches, preferably 0.03 inches. A distal end of a filler tube 208 may be coupled to a point 207 along the exterior surface of balloon 201. For instance, the point 207 could be located approximately ⅓ along balloon's 201 length, as illustrated in FIG. 2 b. In other embodiments, the filler tube 208 may be coupled vertex 206. Such tubes are well known in the art, and illustratively may be made of materials such as PVC. A proximal end of the filler tube 208 may be connected to a fluid reservoir, such as a syringe 210 which may inject a pre-specified amount of fluid into the balloon 201 through the filler tube 208. Also coupled to the distal end of the filler tube 208 may be a fluid control device such a stopcock 212. The injection of fluid through the filler tube 208 inflates the balloon 201 to an inflated condition, as illustrated in FIG. 2 b. Once inflated, the fluid inside the shaping device may be prevented from escaping by locking the stopcock 212. This allows the balloon 201 to stay inflated with the proper volume, shape and contour during the reconstruction procedure.
The fluid pressure inside the balloon 201 may also be monitored by a pressure transducer, such as a piezoelectric transducer (not shown) coupled to the filler tube 208 with a y-connection (not shown). In other words, one lead of the y-connection would be coupled to a pressure monitor and the other lead would be coupled to the fluid source. Alternatively, the pressure monitor could be coupled to a three way stopcock (not shown), which would monitor the pressure on the filler tube side of the three way stopcock.
In another embodiment, the shaping device could have walls that are relatively thick and are coupled to foam spacers or thermoplastic polymer pads surrounding the exterior of the balloon. Turning now to FIG. 2 d, there is shown a section view of an embodiment having polymer pads 232 a through 232 l coupled to the exterior of a balloon 230. In a substantially inflated condition, polymer pads 232 a-232 l provide a plurality of contact points: “A” through “L”. Contact points “A” though “L”, if connected, would define a space of approximately the same volume occupied by the balloon 201 (FIG. 2 a). Consequently, the balloon 230 would need less fluid for inflation and the polymer pads 232 a through 232 l would also provide puncture resistance.
In yet another embodiment, the shaping device could be a balloon within a balloon. FIG. 2 e illustrates such an embodiment. A balloon 250 is generally shown in FIG. 2 e. The balloon 250 comprises an outer balloon 252 and an inner balloon 254. In one embodiment, the inner balloon 254 is inflatable with a fluid, such as saline solution fluid. As in other embodiments, the inner balloon 254 may be inflated through the filler tube 208. A space 256 between the inner balloon 254 and the outer balloon 252 may be pre-filled with a gel 258, such as a silicone gel or saline solution.
The shaping device 280 illustrated in FIG. 2 g is in an expanded condition. Running through the center of shaping device 280 is a main shaft 282. The main shaft 282 has a distal end 284 and a proximal end 286. At the distal end 284 is a joint 288. Coupled to the joint 288 is a series of back ribs 290 a though 290 h (only back ribs 290 a through 290 e are visible in FIG. 2 g). Back ribs 290 a through 290 h are connected to front ribs 292 a-292 h by hinges 294 a though 294 h (only front ribs 292 a-292 e and hinges 294 a-294 e are visible in FIG. 2 g). The proximal end of front ribs 292 a through 292 e are connected to a collar 296 through a series of hinges (not shown) radially spaced around collar 296. The use of hinges around collar 296 encourages front ribs 292 a-292 h to form a convex angle with respect to shaft 282 at collar 296.
FIG. 2 h shows the shaping device 280 in a collapsed position. In a collapsed position, back ribs 290 a-290 h and front ribs 292 a-292 h surround shaft 282 as illustrated in FIG. 2 j. FIG. 2 j is a section view cut transversely through shaft 282 and the front ribs 292 a-292 h. In operation, once the shaping device 280 is inserted into the left ventricle, a surgeon may slide collar 296 along shaft 282 towards distal end 284. The force exerted on collar 296 will cause the ribs to buckle radially outward as illustrated in FIG. 2 g. Eventually, the front ribs 292 a-292 h will bend under the applied force. Because the front ribs 292 a-292 h are under stress, they will tend to push the collar 296 towards proximal end 286. A lock 294 prevents any desired movement towards proximal end 286. Thus, the collar 296 is held firmly in place along shaft 282 by the front ribs 292 a-292 h exerting a force through collar 296 to lock 294. The lock 294 is spring (not shown) activated and is designed such that the collar 296 may easily slide over the lock when moving from the proximal end 286 to the distal end 284. When the surgeon is ready to remove the shaping device 280, the surgeon may collapse the shaping device 280 by pressing down on lock 294 which will allow the collar 296 to slide past the lock 294 towards the proximal end 286.
As will be explained in greater detail below, a patch is often used in the ventricle reconstruction procedure. A patch is made from sheet material and may be a variety of shapes, including circular, elliptical, or triangular, preferably sized and configured with a shape similar to a Fontan neck, as discussed below. As illustrated in FIG. 3 a, an elliptical patch 300 may have a length between 30 and 50 millimeters along a major axis 302 and a width along a minor axis 304 of between 20 and 30 millimeters. The preferable thickness of the patch is in the range of 0.3 to 0.7 mm. The water permeability is preferably less than 5 ml per cm sq. per minute at 120 mm Hg. The burst strength of the patch is preferably 30 to 35 kg/cm2. Finally, the 45° angle suture retention strength of the patch should be greater than 3 kg.
The markings may be radiopaque. Radiopaque markings are made from material that are impenetrable to radiation such as x-rays. Radiopaque markings may be applied to the patch material in a wide variety of methods. For instance, if the patch material is from a woven fabric, then radiopaque threads could be woven into the fabric at regular intervals. Such radiopaque threads could be metal and made from alloys of gold, nitinol, platinum, or stainless steel. Radiopaque threads could also be made of a biocompatible polymeric material mixed with a metal powder, such as barium sulfate. Radiopaque markings could also be imprinted onto the fabric with radiopaque ink. Such ink is available from Creative Imprints Inc., (Norton, Mass.).
Radiopaque threads might interfere with MRI scans because MRI is extremely sensitive to metal and metal can substantially mask MRI signals. However, if metal markings are made sufficiently small, they will show as bands in an MRI scan. Using metal fibers 0.1 mm to 0.05 mm to create the grid or pattern by weaving into the patch can make a patch MRI sensitive. Also, the metal can be applied to the patch by ion deposition which could deposit a layer of metal 0.01 mm thick onto the patch material. Small tubular strands filled with fatty acids could also be used as be used as MRI sensitive markings. Such strands could be woven into the patch material.
Turning now to FIG. 4 a, there is illustrated a set of sizers 402 a-402 d. The sizers 402 a-402 d are shaped to be the approximate size of the patch 300 (FIG. 3 a). Similar to the patch, the sizers 402 a-402 d will be of various geometries, length and width combinations. For illustrative purposes, the sizers 402 a-402 d discussed herein will be elliptical in shape. For posterior repairs to the ventricle, however, the sizers may have a general triangular shape. Referring back to FIG. 4 a, the length of the sizers along a major axis 403 may be in the range of 2 to 7 cm in length. The length along a minor axis 405 may be 1 to 5 cm in length. The sizers may have a connection 406 for attachment to a handle 404 (FIG. 4 b). The sizers 402 a-402 d can be made out of plastic or stainless steel or any rigid material. Four sizers 402 a-402 d are illustrated in FIG. 4 a, however, any number of sizers in a variety of could be provided.
Turning now to FIG. 4 b, the handle 404 may also be made from stainless steel, plastic or any other suitable material. The handle 404 includes a shaft 408 having a proximal end 410 and a distal end 412. The distal end 412 couples to the connection 406 of the sizers 402 a-402 d. The proximal end 410 is coupled to a hand grip 414. The hand grip 414 is sized to fit a human hand. Such hand grips are well known in the art. A surgeon may connect any of the sizers 402 a-402 d to the handle 404. The use of handle 404 with a sizer allows the surgeon to easily estimate the size of the opening to be patched by holding the sizer up to and into the opening. If the sizer is too small, another one may be selected. This process may be repeated until the surgeon feels he has a sizer of the correct shape and size. As will be explained in greater detail below, once the proper size has been determined the sizer may be placed on material and be used as a template to cut the patch 300 to the appropriate size.
In another embodiment, the sizers may have a cutting edge which can be used to cut the patch 300 to the appropriate shape. Turning now to FIG. 4 d, a sizer 430 is shown connected to the handle 408. In this embodiment, the sizer 430 may have a ridge 432 concentric to the shape of the sizer 430. The ridge 432 allows a surgeon to accurately estimate the size of the opening by placing the ridge 432 into the opening. The sizer 430 may also have a circumferential flange or lip 434 around the perimeter of the sizer to assist in defining the patch size. The patch will typically be slightly larger than the size of the opening. The width of the lip 434 will preferably have a constant width around its circumference, typically in the range between 5 and 8 centimeters. A cutting edge 436 may also be coupled to the perimeter of the lip. In operation, the surgeon may use the sizer as illustrated in FIG. 4 d to estimate the size of the opening, remove the sizer 430 from the handle 408, turn the handle over with respect to the handle 408, and reattach the sizer 430 to the handle 408. The cutting edge 436 may then be used to cut the patch material to the correct size and shape by pressing the cutting edge into the patch material.
FIG. 4 g illustrates yet another embodiment of a sizer. The sizer 460 may be a malleable wire 462 coupled to movable legs 464 a-464 d (464 a and 464 b are visible in FIG. 4 g). The moveable legs 464 a-464 d are coupled to a handle 466. The handle 466 includes a shaft 468 having a proximal end 470 and a distal end 472. The distal end 472 couples to the movable legs 464 a-464 d. The proximal end 470 is coupled to a hand grip 474. The hand grip 474 is similar to the handgrip 414 of FIG. 4 b. FIG. 4 h is a section view of the sizer 460 cut through the movable legs 464 a-464 d. The malleable wire 462 may be manipulated by the surgeon into any appropriate shape. Additionally, because one end 476 of the malleable wire 462 is free to slide past the moveable legs 464 a and 464 d, the perimeter of the shape formed by the wire may be lengthened or shortened as desired.
Turning now to FIG. 5 a, there is illustrated a patch holder 500. The patch holder 500 comprises a patch plate 502 coupled to legs 504 a-504 d (504 a and 504 b are visible in FIG. 5 a). The legs 504 a-504 d are coupled to a handle 506, which is similar to handle 466 discussed above. The patch plate 502 has an adhesive means on side 508, such as an adhesive backing or nylon hooks, which temporarily adheres to the patch. In operation, after a surgeon has constructed the appropriate patch, the surgeon may use patch holder 500 to place the patch into the opening, after suturing has begun, the patch holder may be removed, leaving the patch in place.
Referring now to FIGS. 7 a and 7 b, which illustrate generally a method 700 for performing and using at least one embodiment of the present invention. At step 702, a surgeon determines the appropriate size for the patient's left ventricle based on the patient's height, weight, body surface area and other patient specific conditions (as discussed previously in reference to FIG. 2 a). Once the patient's appropriate ventricle size has been determined, at step 704, the surgeon can then select the appropriate volume for the shaping device.
Alternatively, in cases of extensive nonfibrotic trabecular tissue on the lateral ventricle, another suture method can be placement of mattressed braided sutures over a pericardial strip from outside the ventricle to its interior through the inner oval of the patch. This procedure can be done in conjunction with other procedures such as: Mitral valve repair, ablation of ventricular arrhythmias for treatment of refractory ischemic ventricular tachycardia.
With the patch, suitably placed, in step 732, the suture line can be sprayed with a hemostatic agent or an agent can be applied to achieve better and instantaneous hemostasis. In step 734, the operative site can be closed by joining or folding over the myocardial walls. Care should be taken not to distort the right ventricle by folding the septum wall over the ventricular wall. Alternatively, the lateral wall can be disposed interiorly of the septum wall so a majority of the force on the patch is diverted to the lateral wall. These walls can be overlapped in close proximity to the patch in order to avoid creating any cavity between the patch and the walls.
A pacemaker comprises: (1) an implantable controller that sets the heart rate to the desired interval, and (2) two leads that deliver electrical impulses to specific regions of the heart (i.e., one lead is placed in the right atrium and the second lead in right ventricle) to artificially cause contractions of the ventricle at the appropriate time and synchronization. In contrast, BVPs have a third lead designed to conduct signals directly into the left ventricle. When using a BVP, one lead is placed in the right atrium, the second lead in right ventricle, and third lead is placed to pace the left ventricle (i.e., in a tributary of the coronary sinus in the left ventricle). Thus, with a BVP, simultaneous electrical impulses are given to both left and right ventricles so the time delay in traveling of electrical impulse is significantly reduced which aids in restoring the normal physiology of the heart and improves the pumping action of the heart.
2. The kit of claim 1, wherein the source for inflating the expandable shaper is a syringe coupled to the shaper.
3. The kit of claim 1, wherein the expandable shaper comprises elastomenc material.
4. The kit of claim 1, wherein the expandable shaper is configured to be expanded with a fluid.
5. The kit of claim 1, further comprising a pressure transducer, wherein the pressure transducer is configured to monitor a pressure inside the expandable shaper.
6. The kit of claim 1, further comprising a patch holder, wherein the patch holder is configured to place the heart patch on the heart, and wherein the patch holder is configured to be removed after suturing of the heart patch has begun.
8. The kit of claim 7, wherein the source for inflating the expandable shaper is a syringe coupled to the shaper.
9. The kit of claim 7, wherein the expandable shaper comprises elastomeric material.
10. The kit of claim 7, wherein the expandable shaper is configured to be expanded with a fluid.
11. The kit of claim 7, further comprising a pressure transducer, wherein the pressure transducer is configured to monitor a pressure inside the expandable shaper.
12. The kit of claim 7, further comprising a patch holder, wherein the patch holder is configured to place the heart patch on the heart, and wherein the patch holder is configured to be removed after suturing of the heart patch has begun.
14. The kit of claim 13, wherein the source for inflating the expandable shaper is a syringe coupled to the shaper.
15. The kit of claim 13, wherein the expandable shaper comprises elastomeric material.
16. The kit of claim 13, wherein the expandable shaper is configured to be expanded with a fluid.
17. The kit of claim 13, further comprising a pressure transducer, wherein the pressure transducer is configured to monitor a pressure inside the expandable shaper.
18. The kit of claim 13, further comprising a patch holder, wherein the patch holder is configured to place the heart patch on the heart, and wherein the patch holder is configured to be removed after suturing of the heart patch has begun.
a shaper having a size and shape substantially equal to the size and shape of an appropriate left ventricle, wherein the shaper is adapted to be temporarily placed in the left ventricle during the reconstructive surgery.
a source for inflating the shaper.
21. The kit of claim 20, wherein the source for inflating the expandable shaper is a syringe coupled to the shaper.
22. The kit of claim 20, wherein the expandable shaper comprises elastomeric material.
23. The kit of claim 19, wherein the pre-cut heart patches comprise pre-printed suture lines.
24. The kit of claim 19, further comprising a suture hook.
25. The kit of claim 23, further comprising a patch holder, wherein the patch holder is configured to place at least one heart patch on the heart, and wherein the patch holder is configured to be removed after suturing of the at least one heart patch has begun.
Athanasuleas, M.D. et al., "Restoration of Contractile Function in the Enlarged Left Ventricle by Exclusion of Remodeled Akinetic Anterior Segment: Surgical Strategy, Myrocardial Protection, and Angiographic Results", Journal of Cardiovascular Surgery, 1998, pp. 418-428.
C. L. Anthanasuleas et al., "Surgical Anterior Ventricular Endocardial Restoration (SAVER) in the Dilated Remodeled Ventricle After Anterior Myocardial Infarction" Journal of the American College of Cardiology, 2001, vol. 37, No. 5, p. 1199-1209.
Cooley, M.D. et al., "Intracavitary Repair of Ventricular Aneurysm and Regional Dyskinesia", Departments of Cardiovascular Surgery and Cardiology, Texas Heart Institute, Houston, TX, Jan. 1992, pp. 417-442.
Denton A. Cooley, M.D., "Ventricular Endoaneurysmorrhaphy: A Simplified Repair for Extensive Postinfarction Aneurysm", Journal of Cardiac Surgery, vol. 4, no. 3, 1989, pp. 200-205.
Di Donato et al., "Akinetic Versus Dyskinetic Postinfarction Scar: Relation to Surgical Outcome in Patients Undergoing Endoventricular Circular patch Plasty Repair" J Am Coll Cardiol, 1997, 29, No. 7, 1569-75.
Di Donato et al., "Early Hemodynamics Results of Left Ventricular Reconstructive Surgery for Anterior Walls Left Ventricular Aneurysm", The American Journal of Cardiology, vol. 69, Apr. 1, 1992, pp. 886-890.
Di Donato, M.D. et al., "Akinetic Versus Dyskinetic Postinfarction Scar: Relation to Surgical Outcome in Patients Undergoing Endoventricular Circular Patch Plasty Repair", American College of Cardiology, vol. 29, 1997, pp. 1569-1575.
Francis Fontan, M.D., "Transplantation of Knowledge", The Journal of Thoracic and Cardiovascular Surgery, 1990, pp. 387-395.
G. D. Buckberg, "Congestive Heart Failure: Treat the Disease, Not the Sympton-Return to Normalcy" J. Thorac Cardiovasc Surg, 2001, vol. 121, No. 4, p. 628-637.
G. E. Burch et al., "Angle of Traction of the Papillary Muscle in Normal and Dilated Hearts: A Theoretic Analysis of Its Importance in Mitral Valve Dynamics", American Heart Journal, Jul., 1972, vol. 84, No. 1, p. 141-144.
Gerald D. Buckberg M.D., "Commonality of Ischemic and Dilated Cardiomyopathy: Laplace and Ventricular Restoration", The UCLA Medical Center, Department of Surgery, Los Angeles, California, 1999, pp. 53-59.
Gerald D. Buckberg, M.D., "Surgery for Adult Cardiovascular Disease: Editorial: Defining the Relationship between Akinesia and Dyskinesia and the Cause of Left Ventricular Failure After Anterior Infraction and Reversal of Remoldeling to Restoration", 1998, pp. 47-49.
International Preliminary Examination Report for PCT/US02/16304 mailed Jul. 15, 2004.
International Search Report PCT/US02/16304 mailed Aug. 22, 2002.
Interview Summary for U.S. Appl. No. 09/864,510, mailed on Mar. 17, 2004.
Interview Summary for U.S. Appl. No. 09/864,794, mailed on Jul. 14, 2003.
James L. Cox, "Surgical Management of Left Ventricular Aneurysms: A Clarification of the Similarities and Differences Between the Jatene and Dor Techniques", Seminars in Thoracic and Cardiovascular Surgery, vol. 2, No. 2, Apr. 1997, pp. 131-138.
Office Action for U.S. Appl. No. 09/864,510, mailed May 7, 2003.
Office Action for U.S. Appl. No. 09/864,510, mailed on Feb. 19, 2004.
Office Action for U.S. Appl. No. 09/864,510, mailed on Nov. 8, 2002.
T. Kono et al., "Left Ventricular Shape is the Primary Determinant of Functional Mitral Regurgitation in Heart Failure" JACC Dec. 1992, vol. 20, No. 7. p. 1594-1598.
T. Shiga et al. "Deformation of Polyelectrolyte Gels under the Influence of Electric Field" Journal of Applied Polymer Science, 1990, 39, 2305.
U.S. Appl. No. 10/164,146, filed Jun. 5, 2002, Murphy et al.
V. Dor et al., "Endoventricular Patch Plast for Large L.V. Akinesia", Video tape from Centre de Cardio-Thoracique de Monaco, Sep. 1998.
V. Dor et al., "Endoventricular Patch Reconstruction in Large Ischemic Wall-Motion Abnormalities", The Centre Cardio-Thoracique<Monaco, 1999, pp. 46-52.
V. Dor et al., "Left Ventricular Aneurysm: A New Surgical Approach", Thoracic Cardiovascular Surgery 37, Jun. 16, 1988, pp. 11-19.
V. Dor et al., "Surgery For Acquired Heart Disease, Late Hemodynamic Results After Left Ventricular Patch Repair Associated with Coronary Grafting in Patients with Postinfarction Akinetic or Dyskinetic Aneurysm of the Left Ventricle", The Journal of Thoracic and Cardiovascular Surgery, Nov. 1995, pp. 1291-1301.
V. Dor, "Reconstructive Left Ventricular Surgery for Post-Ischemic Akinetic Dilatatin" Seminars in Thoracic Surgery, 1997, 9, No. 2, 139-145.
V. Dor, M.D. et al., "Endoventricular Patch Plasties with Septal Exclusion for Repair of Ischemic Left Ventricle: Technique, Results and Indications from a series of 781 cases", The Japanese Journal of Thoracic and Cardiovascular Surgery, 1998, pp. 389-398.
V. Dor, M.D. et al., "Ventricular Remodeling in Coronary Artery Disease", Centre Cardio-Thoracique de Monaco, 1997, pp. 533-537.
Vincent Dor, "Left Ventricular Aneurysms: The Endoventricular Circular Patch Plasty", Seminars in Thoracic and Cardiovascular Surgery, vol. 2, no. 2, Apr. 1997, pp. 123-130.
Vincent Dor, "Reconstructive Left Ventricular Surgery for Post-Ischemic Akinetic Dilatation", Seminars in Thoracic and Cardiovascular Surgery, vol. 2, no. 2, Apr. 1997, pp. 139-145.
Vincent Dor, "The Treatment of Refractory Ishemic Ventricular Tachycardia by Endoventricular Patch Plasty Reconstruction of the Left Ventricle", Seminars in Thoracic and Cardiovascular Surgery, vol. 2, no. 2, Apr. 1997, pp. 146-155.
Written Opinion for PCT/US02/16304 mailed on May 27, 2003.

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