Source: http://www.google.com/patents/US20060025800?dq=assignee:+google
Timestamp: 2017-10-20 07:20:56
Document Index: 565739079

Matched Legal Cases: ['art.\n1', 'art.\n12', 'art.\n18', 'art 900', 'art 900', 'art 900', 'art 900', 'art 900', 'art 900']

Patent US20060025800 - Method and device for surgical ventricular repair - Google Patents
Embodiments disclose a method for repairing a heart of a human. A method may include introducing a collapsed reinforcing element through the skin into the vascular system of the human. The method may include delivering the reinforcing element into a left ventricle through the arteries. Once inside the...http://www.google.com/patents/US20060025800?utm_source=gb-gplus-sharePatent US20060025800 - Method and device for surgical ventricular repair
Publication number US20060025800 A1
Application number US 11/158,293
Also published as WO2007001482A1
Publication number 11158293, 158293, US 2006/0025800 A1, US 2006/025800 A1, US 20060025800 A1, US 20060025800A1, US 2006025800 A1, US 2006025800A1, US-A1-20060025800, US-A1-2006025800, US2006/0025800A1, US2006/025800A1, US20060025800 A1, US20060025800A1, US2006025800 A1, US2006025800A1
Inventors Mitta Suresh
Original Assignee Mitta Suresh
Patent Citations (6), Referenced by (167), Classifications (13), Legal Events (6)
Method and device for surgical ventricular repair
US 20060025800 A1
Embodiments disclose a method for repairing a heart of a human. A method may include introducing a collapsed reinforcing element through the skin into the vascular system of the human. The method may include delivering the reinforcing element into a left ventricle through the arteries. Once inside the left ventricle, the reinforcing element may be expanded to an expanded shape. In certain embodiments, a reinforcing element may be used to structurally reinforce a portion of an endocardial surface of a heart. The reinforcing element may include a preshaped patch and/or a plurality of preshaped flexible conduits. The method may include deploying the reinforcing element soon after a myocardial infarction to inhibit naturally occurring remodeling of the heart. The reinforcing element may be deployed with or without the use of a shaper. In some embodiments, a reinforcement element may be positioned on/coupled to an external surface of a human heart. In some embodiments, a reinforcing element may include an externally positioned apparatus configured to substantially reshape a portion of an interior chamber of a heart.
1. An apparatus for reshaping at least a portion of a human heart, comprising:
a reinforcing element configured to attach to a portion of the epicardial surface of a left or right ventricle of the heart, wherein the reinforcing element is configured to change a size and/or shape of an interior space in a left or right ventricle.
3. The apparatus of claim 1, wherein the reinforcing element comprises one or more portions configured to facilitate post operative evaluation of a positioned reinforcing element.
6. The apparatus of claim 1, wherein the reinforcing element is attached to a portion of the epicardial surface using sutures.
7. The apparatus of claim 1, wherein the reinforcing element is attached to a portion of the epicardial surface using staples.
9. The apparatus of claim 1, wherein the reinforcing element is configured to inhibit expansion of an average of an endocardial surface over a cardiac cycle of the left or right ventricle.
10. The apparatus of claim 1, wherein the reinforcing element is configured to inhibit expansion of an endocardial surface such that normal contraction and expansion during a cardiac cycle of the heart remains substantially unimpeded.
11. The apparatus of claim 1, wherein the reinforcing element is configured to releasably attach to a portion of the epicardial surface of the heart.
12. The apparatus of claim 1, further comprising an adjustment mechanism, wherein the adjustment mechanism is configured, upon activation, to change a dimension of at least a portion of the reinforcing element.
13. The apparatus of claim 1, further comprising an adjustment mechanism, wherein the adjustment mechanism comprises an inflatable portion configured, upon activation, to change a dimension of at least a portion of the reinforcing element.
16. The apparatus of claim 1, further comprising an adjustment mechanism, wherein the adjustment mechanism is configured, upon activation, to change a dimension of at least a portion of the reinforcing element, and further comprising an engagement mechanism configured to inhibit the activated adjustment mechanism from moving.
17. The apparatus of claim 1, further comprising an activation mechanism, wherein the activation mechanism is configured to attach the reinforcing element to a portion of the surface of the heart.
18. The apparatus of claim 1, wherein the reinforcing element comprises a patch.
20. The apparatus of claim 1, wherein the reinforcing element comprises a patch, wherein the patch comprises two or more openings, wherein the openings are configured to allow elongated members to pass through the openings, and wherein upon activation the elongated members are configured to change a dimension of at least a portion of the reinforcing element, and to thereby change a dimension of at least a portion of the ventricle.
24. The apparatus of claim 1, wherein the reinforcing element comprises a patch, wherein the patch comprises a system of elongated members, and wherein upon activation the elongated members are configured to change a dimension of at least a portion of the reinforcing element, and to thereby change a dimension of at least a portion of the ventricle.
27. The apparatus of claim 1, wherein the reinforcing element comprises shape memory materials.
29. The apparatus of claim 1, wherein the portion of the epicardial surface comprises at least some scar tissue.
30. The apparatus of claim 1, wherein the portion of the epicardial surface comprises at least some infarcted tissue.
31-90. (canceled)
91. A method for reshaping at least a portion of a human heart, comprising:
attaching a reinforcing element to a portion of the epicardial surface of a left or right ventricle of the heart such that
a size and/or shape of an interior space in a left or right ventricle is changed.
92-113. (canceled)
114. The apparatus of claim 1, wherein the reinforcing element is configured to change from a first shape to a second shape upon activation changing a size and/or shape of an interior space in a left or right ventricle.
115. The method of claim 91, further comprising activating the reinforcing element such that the reinforcing element changes from a first shape to a second shape.
This application is a continuation-in-part of U.S. patent application Ser. No. 10/790,669 entitled “METHOD AND DEVICE FOR PERCUTANEOUS SURGICAL VENTRICULAR REPAIR” filed on Mar. 1, 2004, which is a continuation-in-part of U.S. patent application Ser. No. 10/235,295 entitled “METHOD AND DEVICE FOR PERCUTANEOUS SURGICAL VENTRICULAR REPAIR” filed on Sep. 5, 2002, which claims priority to U.S. Provisional Patent Application Ser. No. 60/317,197 entitled “DEVICE AND METHOD FOR ENDOSCOPIC SURGICAL VENTRICULAR REPAIR” filed on Sep. 5, 2001, and U.S. Provisional Patent Application Ser. No. 60/327,221 entitled “METHOD AND DEVICE FOR CLOSED CHEST PLACEMENT OF SEPTUM” filed on Oct. 5, 2001, the disclosures of which are hereby incorporated by reference.
In some embodiments, a system and/or method may be directed to supporting and or to reinforcing myocardial tissue in the region of an infarct site. The system and/or method may cover at least a section of an infarct site. The system may allow a heart to pump more efficiently. The system may inhibit continued remodeling of the akinetic and/or dyskinetic heart tissue. The system may inhibit dilated cardiomyopathy. The system may inhibit aneurismal tissue from forming. The system may inhibit any of the various complications these (and other) conditions may cause. The device may include a feature to stabilize, strengthen, bind, cross link, arrest, and/or delay the tissue remodeling process, or otherwise directly reinforce the infarcted myocardial tissue itself.
In some embodiments, a system may include a patch system. The patch system may include a mechanism for coupling the patch to human tissue (e.g., cardiac tissue). In some embodiments, a patch system may include therapeutic functions. Therapeutic functions may include systems (e.g., pharmaceutical agents) which assist in regenerating human tissue and function. A patch system may include direct therapeutic infusion systems. Therapeutic agents may be directed directly into and around infarcted myocardial tissue. Systems and/or methods may include thermal tissue treatment into and/or around infarcted myocardial tissue.
In some embodiments, a system may include a reinforcing element for reshaping at least a portion of a human heart. The reinforcing element may function to attach to a portion of the epicardial surface of a human heart. The reinforcing element may function to attach to a portion of the epicardial surface of a left or right ventricle of the heart. A reinforcing element may function to change a dimension of at least a portion of a human heart. In some embodiments, a reinforcing element may function to change a size and/or shape of an interior space in a left or right ventricle.
In some embodiments, a reinforcing element may attach to a portion of the epicardial surface of a left or right ventricle of the heart. The reinforcing element may change from a first shape to a second shape upon activation and thereby change a dimension of at least a portion of the ventricle.
In some embodiments, an epicardial surface of a human heart may include at least some scar tissue. In some embodiments, an epicardial surface of a human heart may include at least some infarcted tissue.
The reinforcing element may function to inhibit expansion of an average of an endocardial surface over a cardiac cycle.
In some embodiments, the reinforcing element may include one or more portions which facilitate post operative evaluation of a positioned reinforcing element. At least some of the portions of the reinforcing element which facilitate post operative evaluation may be MRI scan sensitive.
At least some portion of a reinforcing element may include one or more layers coupled together.
A reinforcing element may be coupled or attached to an epicardial surface of a heart in a variety of ways known to one skilled in the art. In some embodiments, a reinforcing element may be attached to an epicardial surface using sutures. The reinforcing element may be attached to a portion of the epicardial surface using staples. The reinforcing element may be attached to a portion of the epicardial surface using biocompatible adhesives. In some embodiments, a reinforcing element may function to releasably attach to a portion of the epicardial surface of the heart
In some embodiments, a reinforcing element may function to inhibit expansion of an average of an endocardial surface over a cardiac cycle of the left or right ventricle.
In some embodiments, a reinforcing element may function to inhibit expansion of an endocardial surface such that substantially normal contraction and expansion during a cardiac cycle of the heart remains substantially unimpeded. Normal contraction and expansion of a heart may be generally defined as contraction and expansion within desired parameters of a healthy heart as defined by a specific patients specifications (e.g., gender, age, height, weight).
In some embodiments, a reinforcing element may include an adjustment mechanism. The adjustment mechanism may function, upon activation, to change a dimension of at least a portion of the reinforcing element. In some embodiments, an adjustment mechanism may include an inflatable portion which functions, upon activation, to change a dimension of at least a portion of the reinforcing element. The inflatable portion may be positioned between an outer surface of the adjustment mechanism and the epicardial surface of the left or right ventricle. In some embodiments, a system may include an inflation mechanism. The inflation mechanism may be removably coupled to the inflatable portion of the reinforcing element. The inflation mechanism may function to convey fluids to the inflatable portion. Fluids may include gasses (e.g., air, inert gasses (e.g., nitrogen, argon)) and/or liquids (e.g., water, gels).
In some embodiments, a reinforcing element may include an adjustment mechanism (as described herein) and an engagement mechanism. The engagement mechanism may function to inhibit an activated adjustment mechanism from moving. The engagement mechanism may function to inhibit an activated adjustment mechanism from moving such that
In some embodiments, a reinforcing element may include an activation mechanism. The activation mechanism may function to attach the reinforcing element to a portion of the surface of the heart.
In some embodiments, a reinforcing element may include a patch. The patch may include two or more openings. The openings may allow elongated members to pass through the openings. Upon activation the elongated members may function to change a dimension of at least a portion of the reinforcing element, and to thereby change a dimension of at least a portion of the ventricle. In some embodiments, the elongated members may include staples. In some embodiments, elongated members may include sutures.
In some embodiments, a reinforcing element may include a patch. The patch may be formed from a system of elongated members. Upon activation the elongated members may change a dimension of at least a portion of the reinforcing element, and to thereby change a dimension of at least a portion of the ventricle. In some embodiments, the elongated members may be coupled to an adjustment mechanism. Upon activation of the adjustment mechanism the elongated members may change a dimension of at least a portion of the ventricle.
In some embodiments, a reinforcing element may be formed from shape memory materials (e.g., nitinol).
FIG. 1 depicts an embodiment of a method of repairing at least a portion of a human heart.
FIG. 2 a depicts an embodiment of a shaping device.
FIG. 2 b depicts an embodiment of a shaping device in an expanded condition.
FIG. 2 c depicts an embodiment of a shaping device in a collapsed condition.
FIG. 2 d depicts an embodiment of a shaping device in an expanded condition.
FIG. 2 e depicts an embodiment of a shaping device in a collapsed condition.
FIG. 3 a depicts an embodiment of a shaping device deployed within a human heart.
FIG. 3 b depicts an embodiment of a human heart before remodeling.
FIG. 4 depicts an embodiment of a shaping device deployed within a human heart.
FIG. 5 depicts an embodiment of a method of repairing at least a portion of a human heart.
FIG. 6 depicts an embodiment of a method of repairing at least a portion of a human heart.
FIG. 7 depicts an embodiment deployed within a human heart.
FIG. 8 a depicts an embodiment deployed within a human heart.
FIG. 8 b depicts an embodiment deployed within a human heart.
FIG. 8 c depicts an embodiment deployed within a human heart.
FIG. 8 d depicts an embodiment deployed within a human heart.
FIG. 9 depicts an embodiment of a newly infarcted left ventricle with anterior-apical scar.
FIG. 10 depicts an embodiment of the ventricle in depicted in FIG. 9.
FIG. 11 depicts an embodiment of the ventricle in depicted in FIG. 9 including a reinforcing element.
FIG. 12 depicts an embodiment of a ventricle including a reinforcing element after a period of time has passed since placement of the reinforcing element.
FIG. 13 depicts an embodiment of a reinforcing element.
FIG. 14 depicts an embodiment of a shaper that matches the object in FIG. 13.
FIG. 15 depicts an embodiment of a reinforcing element with a coupling mechanism in an activated/engaged state.
FIG. 16 depicts an embodiment of a portion of a reinforcing element including a sectional view of one conduit of the reinforcing element with a coupling mechanism in an inactivated/disengaged state.
FIG. 17 depicts an embodiment of a portion of a reinforcing element including a sectional view of the reinforcing element with coupling mechanism in an activated/engaged position.
FIG. 18 depicts an embodiment of a portion of a reinforcing element with a coupling mechanism in an inactivated/disengaged state.
FIG. 19 depicts an embodiment of a portion of a reinforcing element with a coupling mechanism in an activated/engaged state.
FIG. 20 depicts an embodiment of a portion of a reinforcing element with a coupling mechanism in an activated/engaged state positioned in a left ventricle of a heart wherein the portions of the coupling mechanism extend partially into an endocardial wall surface.
FIG. 21 depicts an embodiment of a portion of a reinforcing element with a coupling mechanism in an activated/engaged state positioned in a left ventricle of a heart wherein the portions of the coupling mechanism extend through an endocardial wall surface.
FIG. 22 depicts an embodiment of a portion of a reinforcing element with a coupling mechanism.
FIG. 23 depicts an embodiment of a portion of a reinforcing element with a coupling mechanism positioned in a left ventricle of a heart wherein the portions of the coupling mechanism extend through an endocardial wall surface.
FIG. 24 depicts an embodiment of a reinforcing element.
FIG. 25 depicts an embodiment of a reinforcing element cut to be placed in a patient.
FIG. 26 depicts an embodiment of a sectional view of a dilated heart with a reinforcing element.
FIG. 27 depicts an embodiment of a reinforcing element including an adjustment mechanism in an inactivated state.
FIG. 28 depicts an embodiment of a reinforcing element including an adjustment mechanism in an activated state.
FIG. 29 depicts an embodiment of a portion of a reinforcing element including a sectional view of the reinforcing element with adjustment mechanism in an inactivated/disengaged position.
FIG. 30 depicts an embodiment of a portion of a reinforcing element including a sectional view of the reinforcing element with adjustment mechanism in an activated/engaged position.
FIG. 31 depicts an embodiment of a reinforcing element.
FIG. 32 depicts an embodiment of a reinforcing element coupled to a portion of a human heart during use.
FIG. 33 depicts an embodiment of a method for positioning a reinforcing element.
FIG. 34 depicts an embodiment of a human heart including a depiction of infarcted tissue.
FIG. 35 depicts an embodiment of a human heart with an area of infarcted tissue.
FIG. 36 depicts an embodiment of a human heart with suture or staples coupled to the heart over the infarcted tissue.
FIG. 37 depicts an embodiment of a human heart with suture or staples coupled to the heart over the infarcted tissue, before and after the infarcted area has been reduced.
FIG. 38 depicts an embodiment of a human heart with suture or staples coupled to the heart over the infarcted tissue, before the infarcted area has been reduced.
FIG. 39 depicts an embodiment of a patch including openings.
FIG. 40 depicts an embodiment of a wire mesh patch.
FIG. 41 depicts an embodiment of a patch including coupling mechanisms.
FIG. 42 depicts an embodiment of a patch including an inflatable/expandable portion.
In some embodiments, a shaping device may be pre-shaped to generally model the appropriate volume and shape of the left ventricle, as is depicted in FIG. 2 a. Shaping device 200 may be used as a guide in reforming the left ventricle so that the reconstructed heart may be formed closer to the size and shape of the pre-enlarged heart. Consequently, the heart performs better post operatively than with conventional methods. As illustrated in FIG. 2 a, shaping device 200 may be conical or “tear drop” in shape. The length of shaping device 200 may vary with each patient and will typically be a function of the volume selected for the shaping device. The size, shape, and/or volume of shaping device 200 may vary according to individual patient specific needs. Shaping device 200 may be designed and manufactured for a specific patient's needs. In some embodiments, shaping device 200 may be manufactured in a variety of sizes, shapes, and/or volumes, from which a user may select an appropriate shaping device for a specific patient. Depending on the patient, the length may be between about three inches to about four inches to generally match the length of the pre-enlarged left ventricle. A doctor may select the appropriate volume for the shaping device by estimating the volume of the pre-enlarged left ventricle. Such selection procedures and shaping devices are discussed in U.S. patent application Ser. No. 09/864,510, filed on May 24, 2001 by the inventors, which is hereby incorporated by reference into this application.
In some embodiments, such as illustrated in FIG. 2 a, the shaping device may be inflatable balloon 202 coupled to filler tube 204. Such tubes are well known in the art, and illustratively may be made of plastic-type materials such as PVC. A proximal end of filler tube 204 may be connected to a fluid reservoir (not shown), which may be used to fill a pre-specified amount of fluid into balloon 202 through filler tube 204. A fluid reservoir may include, for example, a syringe. The injection of fluid through filler tube 204 inflates balloon 202 to an inflated condition.
In certain embodiments, a shaping device may include a wire skeleton or frame, as illustrated in FIG. 2 b. The wire frame could be made from surgical grade stainless steel, titanium, tantalum, and/or nitinol. Nitinol is a commercially available nickel-titanium alloy material that has shape memory and is super elastic. Nitinol medical products are available from AMF of Reuilly, France, and Flexmedics Corp., of White Bear Lake, Minn.
Shaping device 210 illustrated in FIG. 2 b is in an expanded condition. In this embodiment, main wire 212 may run through the center of shaping device 210. Coupled to the main wire may be a series of back ribs 214 a through 214 d. Back ribs 214 a through 214 d may be coupled to collar 216.
FIG. 2 c shows shaping device 210 in a collapsed position. In a collapsed position, back ribs 214 a-214 d surround main wire 212. During use, once shaping device 210 is inserted into the left ventricle, a user may cause collar 216 to slide along main wire 212 towards distal end 218 of the wire. The force exerted on collar 216 will cause the ribs to buckle radially outward as illustrated in FIG. 2 b to a predetermined shape.
Some embodiments may include a wire mesh system such as illustrated in FIG. 2 d. Wire mesh shaper 218 may be formed of a tubular fabric made from a plurality of wire strands. The wire strands forming wire mesh shaper 218 may have a predetermined relative orientation between the strands. Those skilled in the art will appreciate that the pick and pitch of the braided wires may be varied depending upon the desired density of the fabric. The tubular fabric may have metal strands which define two sets of essentially parallel generally spiraling and overlapping strands, with the strands of one set having a “hand”, i.e. a direction of rotation, opposite that of the other set. This tubular fabric is known in the fabric industry as a tubular braid.
Without any limitation intended, suitable wire strand materials may be selected from a group including a cobalt-based low thenrmal expansion alloy referred to in the field as ELGELOY, nickel-based high temperature high-strength “superalloys” (including nitinol) commercially available from, for example, Haynes International under the trade name HASTELLOY, nickel-based heat treatable alloys sold under the name INCOLOY by International Nickel, and/or a number of different grades of stainless steel. One important factor in choosing a suitable material for the wire strands is that the wires retain a suitable amount of the deformation induced by a molding surface when subjected to a predetermined heat treatment.
When the tubular braid, for example, is in its preformed relaxed configuration 218 as illustrated in FIG. 2 d, the wire strands forming the tubular braid will have a first predetermined relative orientation with respect to one another. As the tubular braid is compressed along its axis 222, the fabric will tend to flare out away from axis 222 conforming to the shape of the mold. When the fabric is so deformed the relative orientation of the wire strands of the metal fabric will change. After undergoing the shape memory process, the resulting medical device has a preset relaxed configuration 218 as illustrated in FIG. 2 d and a collapsed or stretched configuration 220 as illustrated in FIG. 2 e, which allows the device to be passed through a catheter or other similar delivery device.
A delivery device or catheter (not shown) may take any suitable shape. In some embodiments, a delivery device may include an elongated flexible metal shaft having a threaded distal end. The delivery device may be used to urge the wire mesh shaper 218 through the lumen of a catheter for deployment in a channel of a patient's body. When the device is deployed out the distal end of the catheter, the device may still be retained by the delivery device. Once wire mesh shaper 218 is properly positioned, the distal end of the catheter maybe pressed against the medical device and the metal shaft or guidewire may be rotated about its axis to unscrew the medical device from the threaded distal end of the shaft. The catheter and guidewire may or may not be withdrawn at this point.
As will be explained below, in some embodiments of a method, a patch maybe used in method 100. In an embodiment, the patch may be made from sheet material. The patch may be a variety of shapes, including circular, elliptical, or triangular in shape. In certain embodiments, a sheet material for a patch may be formed from a biocompatible synthetic material, for example, from polyester (e.g., Dacron (Hemoshield™) manufactured by the DuPont Corporation), or polytetrafluoroethylene (e.g., Gortex™). The sheet material may also be autologous pericardium, or some other fixed mammalium tissue such as bovine pericardium or porcine tissue. The biocompatible synthetic material patch may be collagen impregnated to assist in hemostasis, or it may be sprayed with a hemostatic sealant to achieve better and instantaneous hemostasis.
In some embodiments, on one side of a patch, there may be a means of adhering the patch to the endocardium or inside of the heart. The patch may have markings that enable the movement and position of the patch to be post-operatively observed and analyzed under imaging systems, such as for example Magnetic Resonance Imaging (“MRI”), x-ray machines, fluoroscopy and/or other external visualization methods for post-operative clinical evaluation. Such markings will allow identification of the patch and allow for analysis of the heart's contractility in future post-operative evaluations. The markings may be radiopaque. Such radiopaque markings are discussed in U.S. patent application Ser. No. 09/864,510, filed on May 24, 2001 by the inventors, which has been incorporated by reference into this application.
In a bypass procedure, the femoral vein and artery are cannulated to connect the patient to the cardiopulmonary bypass machine. After the bypass machine is running, the shaping device is manipulated to deploy from a collapsed state to an expanded shape. In some embodiments, markings on the controlling handle will provide feedback to the user on how the shaping device is positioned so that he knows where the patch is in relation to the ventricle. A positioning device on the shaping device will align with an anatomical landmark inside the ventricle (e.g., the aortic annulus) to provide another reference location for the shaping device. In 106, the shaping device may be deployed into an expanded condition, as shown in FIG. 3 a.
In 108, the wall of the ventricle may be imbricated over the shaping device, as shown in FIG. 3 b. The term “imbricating” as used in this application generally means to bring together two edges of the ventricle wall that have non-viable tissue between them and excluding this portion of the ventricle wall, which will basically reshape the ventricle. The shaping device may help determine which edges should be brought together. However, some non-viable tissue may be left in the ventricle in order to reshape the ventricle to the appropriate size and shape.
In order to imbricate or reform the ventricle wall over the shaping device, a molding instrument may be inserted into the chest through a small opening in an intercostal space to reach the epicardium. This molding instrument will allow the surgeon to press the ventricle wall against the shaping device to help reshape the ventricle, as shown in FIG. 3 b. This molding instrument may be withdrawn. A clasping instrument may be inserted. The molding instrument and clasping instrument may be one device. This clasping instrument will take portions or “bites” out of the ventricle wall starting at the edges of the area of non-viable tissue that needs to be excluded to restore the ventricle to its correct shape, size, and/or contour. The bites may be made with suture type devices, stapling devices, and/or clip type devices, for example. The clasping instrument may be partially closed to allow the user to ensure that he is properly shaping the ventricle onto the shaping device. If the user determines that he has the clasping instrument placed properly, the device will allow for full closure. The implements placed by the clasping instrument when closed will have pulled the ventricle wall over the shaping device and will maintain the ventricle's shape. Turning back to FIG. 1, once the shaping is complete, in 1 10, the shaping device may be collapsed and removed from the ventricle (112). In some embodiments, intraoperative imaging may be used during this procedure to aid the surgeon's view of the mandrel and/or ventricle interface.
FIG. 6 depicts an embodiment for a method of reinforcing a dilated portion of an endocardial surface of a human heart. In this embodiment, a user preoperatively determines the location, size, and shape of the area of the septum to be reinforced. The user determines which appropriate reinforcing element will match the patient needs. Such reinforcing elements may be made from biocompatible materials and may take many forms. For instance, a patch material (discussed above) may be used. Such materials may be encapsulated within a deploying and securing mechanism that would allow them to be attached to the septal wall. An example of a reinforcing element may include a device made from shape memory metal that has the shape of the area to be reinforced and has biocompatible material covering the metal framework. As discussed above, the metal frame may be made of shape memory materials. The metal frame may provide a means to secure the material. The material may give substance to the metal frame to resist the pressure in the left ventricle. The reinforcing element may have radiopaque markings. Radiopaque markings may be positioned in a pattern that allows them to be viewed and analyzed postoperatively. The radiopaque markings may have a shape that matches the area to be reinforced. The reinforcing element may be shaped to match the patient anatomy and extent of injury. The securing device may have a mechanism by which the reinforcing element may be secured to the septum along the border zone between viable and non-viable tissue. In certain embodiments, the reinforcing element may have a first surface and a second surface. The first surface may be adapted to match the dilated portion of the endocardium. The second surface may be adapted to match an appropriate shape of the left ventricle. Thus, the reinforcing element may be used to reshape the ventricle.
Turning back to FIG. 6, in 602, a user may insert a first catheter with a distal and proximal end percutaneously into a vasculature or vascular system (such as the jugular vein or the femoral vein) of the patient. The user may route a guidewire through a vein into the right ventricle in the vicinity of the area to be reinforced. With the guide wire in place, in 604, the surgeon may guide the first catheter into the right ventricle, as illustrated in FIG. 8 a. Once the first catheter is in place, in 606, an incision may be made into the septal wall. In one embodiment, the incision may be accomplished with the aid of a trocar. The trocar may be advanced along the guide wire and positioned at the point in the septum that is generally the central point of the thinned septal region. The trocar may be pushed through the thinned septal wall to create a path between the right and left ventricles.
In 608, the guidewire may be advanced into the left ventricle from the right ventricle and, if a trocar is used, it may be withdrawn. In 610, a second catheter may be inserted over the guidewire such that the second catheter is introduced into the left ventricle. However, the second catheter may be coupled to a reinforcing element, as described above. In 612, the reinforcing element may be deployed in order to reinforce the portion of the endocardial surface, as illustrated in FIG. 8 b. For instance, in the left ventricle side of the septum, one portion of the reinforcing element may be deployed with the edges of the device and securing mechanism resting on viable tissue of the septum at the border zone of the non-viable septal tissue. A second part of the securing mechanism may be deployed in the right ventricle and secured to the septal wall, as depicted in FIGS. 8 c and 8 d. A securing mechanism may be a type of mechanism used to occlude ventricular septal defects. NMT Medical (Massachusetts), W.L. Gore (Arizona) and AGA Medical Corporation (Minnesota) manufacture such devices. In 614, all components may be withdrawn from the right ventricle and the procedure is completed.
FIG. 10 depicts heart 900 after remodeling as a result of a myocardial infarction. Infarcted area 906 is depicted with the infarcted area thinned and the radius substantially increased. Thinning of infarcted area 906 and/or an increase in radius of the ventricle leads to an increase in wall stress. Also, the disfigured infarcted area 906 may result in global expansion of the ventricle. Note that radius 904 at the apex has increased and subsequently the volume of ventricular cavity 902 is substantially larger in FIG. 10 than in FIG. 9.
FIG. 16 depicts a cross sectional view of a portion of reinforcing element 908, including one conduit 910 and one elongated member 912. Elongated member 912 is depicted in a retracted/inactivated state in FIG. 16. Elongated member 912 may be formed from a substantially flexible material such that the distal end 914 may bend and flex so as to be positionable in conduit 910 when in a retracted state. When elongated member 912 is in an extended/activated state distal end 914 may change shape to a substantially inwardly curled state (as depicted in FIG. 17). Distal ends 914 in the substantially curled state may pierce tissue (when positioned in a portion of a heart) attaching reinforcing element 908 to the portion of the heart.
FIG. 19 depicts an embodiment of a portion of reinforcing element 908 with a coupling mechanism including coupling portions in an activated/engaged state. Upon penetrating tissue coupling portions 915 may be activated and change shape. Coupling portions may change shape into a second form as depicted in FIG. 19. The second form may inhibit extraction of the coupling portions from penetrated tissue, effectively attaching the reinforcing element to an endocardial surface of a heart.
Heat generated (∝) may be expressed in the equation: I2 R. Where I is Current, and R is electrical resistance of the device/material.
In some embodiments, distal ends of coupling portions may be positioned substantially in an endocardial surface of a ventricle upon positioning a reinforcing element. Once positioned one or more of the coupling portions may be activated changing the shape of the activated coupling portion from a first form to a second form. The second form may inhibit extraction of the distal ends of the activated coupling portions from the endocardial surface of the ventricle. FIG. 20 depicts an embodiment of a portion of reinforcing element 908 with a coupling mechanism in an activated/engaged state positioned in a left ventricle of a heart wherein portions 915 of the coupling mechanism extend partially into an endocardial surface surface.
Some embodiments may include an activation mechanism such as is depicted in FIGS. 16 and 17. Activation mechanism 916 may include a center region. The center region may function to couple at least two elongated members 912. The activation mechanism may be formed by coupling at least some of the proximal ends of the elongated members to each other. The activation mechanism may be formed by coupling at least two of the conduits to the center region. The conduits coupled to the center region may radiate out from the center region. In an inactivated state, as depicted in FIG. 16, the activation mechanism may include portions of elongated members 912 forming a convex shape. Activation mechanism 916 may be activated by applying pressure and inverting the convex shape to a concave shape. Inverting the convex shape to a concave shape pushes elongated members 912 further in and through conduits 910, extending distal ends 914 beyond the. distal ends of the conduits.
FIG. 24 depicts an embodiment of reinforcing element 908 which may be “cone shaped” similar to the lower portion of the left ventricle. This conical shape may be open at base 932 of the patch and have tip 934, which may function as a new apex after insertion into the patient.
In some embodiments, a tissue contact surface of a reinforcing element may be partially or completely concave, convex, flat, or a combination.
In some embodiments, a reinforcing element may be made and sold in a selection of stock sizes (e.g., based on size, ventricular volume reduction, distance from the ventricular septal apex, and/or other basis). The reinforcing element may be formed according to a particular patient using the Chase Medical SIMON system, and or any other suitable imaging and or evaluation means.
In some embodiments, a reinforcing element may include at least one suture, wire, rod, bar, band, sheet, ribbon, combination or other suitable structural device. Structural devices may be formed from shape memory or superelastic material (e.g., Nitinol), polymer, metal, metal alloy, or combination of the above materials, and/or any suitable material.
In some embodiments, a reinforcing element may have at least one hole, slot, groove, combination or other, at one or more locations, to modify/effect the flexibility, elasticity, or compression force of the reinforcing element.
In some embodiments, a reinforcing element may include, as a separate component, and/or a coating. The component or coating may be formed from barium sulfate, bismuth trioxide, tantalum, platinum, gold, a combination of the above, or other radiopaque substance. The component or coating may increase the visibility using fluoroscopy, and or to be used as a marker and or reference points.
FIG. 28 depicts an embodiment of reinforcing element 908 including adjustment mechanism 918 in an activated state. Upon attaching the reinforcing element to a portion of an interior/endocardial surface of a ventricle, the adjustment mechanism may be activated. In some embodiments, activating an adjustment mechanism may reduce the diameter/radius of the reinforcing element and consequently reduce the diameter/radius of the portion of the ventricle. Reduction of a diameter of a portion of an enlarged ventricle may reduce the diameter of the portion to a pre-enlarged diameter.
FIGS. 29 and 30 depict one embodiment of engagement mechanisms 920. In some embodiments, engagement mechanisms may be any mechanism that will substantially inhibit undesirable movement of an adjustment mechanism once the adjustment mechanism has been positioned by a user. In certain embodiments, for example, engagement mechanisms 920 may be coupled to one or more conduits 910 of reinforcing element 908. The engagement mechanisms may be positionable along at least a portion of the conduit to allow a user to adjust the activated position of the engagement mechanism relative to the deployed reinforcing element.
In some embodiments, sutures may be employed to couple a reinforcement element to a surface of a heart. Sutures may be applied manually by hand. Sutures may be applied using assistance, such as that provided by an auto suture device (e.g., Sutura SuperStich).
In some embodiments, biocompatible glues or adhesives may be used to couple a reinforcing element to a surface of a heart. The reinforcing element (e.g., patch) may have a biocompatible contact adhesive or other material to bond or secure the reinforcing element to the target tissue. Adhesives may be used to secure, or assist in securing together layers of a reinforcing element. The adhesive/bonding compounds/solutions may be added during the manufacturing process, just prior to deployment, and/or after the reinforcing element has been deployed. Bonding materials may be in the form of a liquid, semi solid, and/or solid.
Suitable bonding materials may include gels, foams and/or microporous mesh. Suitable adhesives may include acrylates, cyanoacrylates, epoxies, fibrin-based adhesives, other biological based adhesives, UV light and/or heat activated and/or other specialized adhesives. The adhesive may bond on initial contact, or take longer to bond, to allow repositioning if desired.
In some embodiments, an adhesive or glue may include a crystalline polymer that changes from a non-tacky crystalline state to an adhesive gel state when the temperature is raised from room temperature to body temperature. One example of such a material is available under the trade name Intillemer™ adhesive, available from Landec Corp. as well as composites and combinations thereof and combinations of other materials. Suppliers of surgical adhesives include, but aren't limited to, Plasto (Dijon, France), Haemacure (Montreal, Canada), Cohesion (Palo Alto, Calif.), Cryolife (Kennesaw, Ga.), TissueLink (Dover, N.H.), and others.
To increase the work time of the adhesive or allow repositioning of the device after it has been deployed, the adhesive may be blended with a material, such as a starch or other material, that dissolves and retards or delays bonding to allow repositioning of the device after it has been deployed. A degradable coating can be placed over the adhesive coating so that it degrades and exposes the adhesive to the target tissue.
In some embodiments, adhesives or glues may include hydrophilic gels (hydrogels), foams, gelatins, regenerated cellulose, polyethylene vinyl acetate (PEVA), as well as composites and combinations thereof and combinations of other biocompatible swellable or expandable materials.
In some embodiments, securing mechanisms may be employed to secure a reinforcing element to a surface of a heart. Securing mechanisms or anchors may inhibit movement and/or dislodgement upon being deployed into tissue. Securing mechanisms may include anchoring features. Anchoring features may include barbed anchor features. Anchoring features may include coiled anchor features. Anchoring features may assist securing mechanisms to inhibit movement of a reinforcement element after deployment. Securing mechanisms may be self-expanding. Securing mechanisms may be formed from shape memory or superelastic materials (e.g., polymer, metal, or metal alloys). Securing mechanisms may be formed from swellable materials. Securing mechanisms may be formed from any combination of discussed or other suitable materials.
In some embodiments, securing mechanisms may include one or more tissue perforating elements. Tissue perforating elements may assist in inhibiting movement of a reinforcing element. At least one perforating element may be inserted or otherwise attached, partially or completely through at least one tissue wall. The perforating element may be coated with a material to positively effect hemostasis, healing, and/or for any other purpose.
Reinforcing element 908 may be preshaped from biocompatible materials that substantially inhibit deformation of the reinforcing element. In some embodiments, an externally placed reinforcing element may be formed from one solid continuous piece of biocompatible material. In some embodiments, a reinforcing element may be formed from more than one type of material.
In some embodiments, a reinforcing element may be fabricated using several methods and processes including sintering, molding (e.g., injection molding), casting, adhesive bonding, laminating, dip coating, spraying as well as composites and combinations thereof and combinations of other suitable methods and processes.
In some embodiments, a reinforcing element may be formed from woven or knitted Dacron polyester. In some embodiments, a reinforcing element may be formed from woven or knitted biocompatible fabric. In some embodiments, a reinforcing element may be formed from polymer, metal, metal alloy, or a combination or other suitable material. Reinforcing elements may be formed from autogenous/autologous, and/or synthetic biocompatible materials. Synthetic biocompatible materials may include silicone, rubber, polyurethane, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), polyester, Dacron™, Mylar™, polyethylene, PET (Polyethylene terephthalate), polyamide, polyamide, PVC, Kevlar™ (polyaramid), polyetheretherketone (PEEK), polypropylene, polyisoprene, polyolefin, or a composite of these or other suitable materials.
In some embodiments, a reinforcing element may be partially or completely made from many different types of biodegradable/bioerodible/bioabsorbable materials. Biodegradable/bioerodible/bioabsorbable materials may include modified starches, gelatins, cellulose, collagen, fibrin, fibrinogen, connective proteins or natural materials (e.g., elastin), polymers or copolymers (e.g., polylactide [poly-L-lactide (PLLA), poly-D-lactide (PDLA)], polyglycolide, polydioxanone, polycaprolactone, polygluconate, polylactic acid (PLA), polylactic acid-polyethylene oxide copolymers, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids), poly(alpha-hydroxy acid)) or related copolymers of these materials, as well as composites and combinations thereof and combinations of other biodegradable/bioabsorbable materials.
A reinforcing element may be partially or completely fabricated from materials that swell or expand when they are exposed to a fluid (e.g., blood, another body fluid, or an infused fluid). These materials may include hydrophilic gels (hydrogels), foams, gelatins, regenerated cellulose, polyethylene vinyl acetate (PEVA), as well as composites and combinations thereof and combinations of other biocompatible swellable or expandable materials.
In some embodiments, a reinforcing element may include a surface coating. The surface coating may be formed from biocompatible materials. Applying a biocompatible surface coating to the reinforcing element may allow the reinforcing element to be formed from one or more potentially non-biocompatible materials. Non-biocompatible materials may be desirable for use due to other preferred properties (e.g., structural properties).
At least one coating may be located on a surface, as well as inside a reinforcement element. The reinforcement element may be coated with hydrophilic materials that are biologically inert and reduce surface friction (e.g., materials such as Parylene). One method to reduce surface tension for any metallic or metallic alloy elements or components of the reinforcement element is to chemically polish or electropolish those surfaces that will come in contact with blood or tissue. Sandblasting, beadblasting, or other known methods may be performed prior to polishing. Chemical polishing or electropolishing may reduce platelet adhesion because of the smooth surface that results. Chemical polishing and or electropolishing process may be used as an effective way to reduce the thickness of any metal or metal alloy device components.
The e.g., may incorporate one or more coatings, materials, compounds, substances, drugs, therapeutic agents, etc. that positively affect healing. Tissue adjacent the reinforcement element, at the tissue attachment site, at and or near where the reinforcement element is located may be positively affected by compounds incorporated into the reinforcement element. Compounds may be either incorporated into the structure forming the device, incorporated into a coating, contained within a reservoir on or inside the device, or a combination of locations. Thromoboresistance materials, antiproliferative materials, or other coatings intended to prevent thrombosis (acute and or chronic), hyperplasia, platelet aggregation, or other negative response, at or near the attachment of the reinforcement element may be incorporated and/or used in combination with the reinforcement element. The coatings, materials, compounds, substances, drugs, therapeutic agents, etc. may be used by themselves, and/or contained in a carrier such as a polymeric matrix, starch, or other suitable material or method. The coatings may be liquid, gel, film, uncured, partially cured, cured, combination or other suitable form.
Coatings on or in any component of the reinforcement element may be used to deliver therapeutic and pharmaceutic agents. Therapeutic and pharmaceutic agents may include (but are not limited to): antiproliferative/antimitotic agents including natural products such as vinca alkaloids (e.g., vinblastine, vincristine, and vinorelbine), paclitaxel, epidipodophyllotoxins (e.g., etoposide, teniposide), antibiotics (dactinomycin (actinomycin D) daunorubicin, doxorubicin and idarubicin), anthracyclines, mitoxantrone, bleomycins, plicamycin (mithramycin) and mitomycin, enzymes (e.g., L-asparaginase which systemically metabolizes L-asparagine and deprives cells which do not have the capacity to synthesize their own asparagine); antiplatelet agents such as G(GP) II.sub.b/III.sub.a inhibitors and vitronectin receptor antagonists; antiproliferative/antimitotic alkylating agents such as nitrogen mustards (mechlorethamine, cyclophosphamide and analogs, melphalan, chlorambucil), ethylenimines and methylmelamines (hexamethylmelamine and thiotepa), alkyl sulfonates-busulfan, nirtosoureas (carmustine (BCNU) and analogs, streptozocin), trazenes—dacarbazinine (DTIC); antiproliferative/antimitotic antimetabolites such as folic acid analogs (methotrexate), pyrimidine analogs (fluorouracil, floxuridine, and cytarabine), purine analogs and related inhibitors (mercaptopurine, thioguanine, pentostatin and 2-chlorodeoxyadenosine {cladribine}); platinum coordination complexes (e.g., cisplatin, carboplatin), procarbazine, hydroxyurea, mitotane, aminoglutethimide; hormones (e.g., estrogen); anticoagulants (e.g., heparin, synthetic heparin salts and other inhibitors of thrombin); fibrinolytic agents (e.g., tissue plasminogen activator, streptokinase and urokinase), aspirin, dipyridamole, ticlopidine, clopidogrel, abciximab; antimigratory; anti secretory (breveldin); anti-inflammatory: such as adrenocortical steroids (cortisol, cortisone, fluorocortisone, prednisone, prednisolone, 6.alpha.-methylprednisolone, triamcinolone, betamethasone, and dexamethasone), non-steroidal agents (salicylic acid derivatives i.e. aspirin; para-aminophenol derivatives (e.g., acetominophen; indole and indene acetic acids (e.g., indomethacin, sulindac, and etodalac)), heteroaryl acetic acids (e.g., tolmetin, diclofenac, and ketorolac), arylpropionic acids (e.g., ibuprofen and derivatives), anthranilic acids (e.g., mefenamic acid, and meclofenamic acid), enolic acids (e.g., piroxicam, tenoxicam, phenylbutazone, and oxyphenthatrazone), nabumetone, gold compounds (e.g., auranofin, aurothioglucose, gold sodium thiomalate); immunosuppressives: (e.g., cyclosporine, tacrolimus (FK-506), sirolimus (rapamycin), azathioprine, mycophenolate mofetil); angiogenic agents: vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF); angiotensin receptor blockers; nitric oxide donors; anti-sense oligionucleotides and combinations thereof; cell cycle inhibitors, mTOR inhibitors, and growth factor signal transduction kinase inhibitors. A clot promoter may be used, such as protamine sulphate or calcium hydroxide. Endothelial cells may also be added to the reinforcement element.
Therapeutic compounds/solutions may be blended with a reinforcement element's base materials during fabrication, applied just prior to deployment, and/or after the reinforcement element has been deployed. The therapeutic materials may be located on, through, and/or inside of the reinforcement element. Therapeutic materials may be located in holes, grooves, slots (or other indentations) and/or other designs. For example, the tissue contacting surface may have partial or complete holes, grooves, or other indentations, filled with a therapeutic substance, in contact with the host vessel tissue.
In some embodiments, a reinforcement element may be formed from multiple layers. The reinforcement element may include a reservoir. The reservoir may include therapeutic agents. Therapeutic agents may elute from the reservoir into tissue contacting a surface of the reinforcement element. In some embodiments, the reservoir may be connected to a tissue-perforating element or anchor.
A reinforcement element may be formed from any suitable material to stabilize, strengthen, cross link, arrest or delay the heart tissue remodeling process, or otherwise reinforce the infarcted myocardial tissue itself. A reinforcement element may include binding agents, collagen (e.g., through direct infusion, and or as a result of tissue heating), therapeutic substance, pharmacologic compounds or materials, radioactive material, genetic material (e.g., stem cells, etc.), a combination of any of the above, or any other suitable material(s).
Securing mechanisms such as coils, or other anchors may also have partial or complete holes, slots, grooves, or other openings filled with a therapeutic substance, or simply coated on the outside surfaces. Designs such as this may allow tissue direct contact with therapeutic substances, while maintaining the functional ability of the device or securing mechanism. Combinations of therapeutic substances or coatings may be used on the same device. For example, a more viscous (gel or other) therapeutic substance may be used to fill the partial or complete holes (or other) on the securing mechanisms, while the main body of the devise is coated with a less viscous (liquid) material. Therapeutic substances may be the same, or a combination of more than one type used on the device and/or securing mechanisms. The coatings may be designed to provide benefits acutely, and/or over a period of time. The coatings, materials, compounds, substances, therapeutic agents, etc. may be desired to be static, and/or eluting. The coatings, materials, compounds, substances, therapeutic agents, etc. may elute from the coated (or embedded) device (or component) over time and enter the surrounding and or adjacent tissue. The coatings, materials, compounds, substances, drugs, therapeutic agents, etc. may remain on the reinforcement element for at least three days, and up to approximately six months or longer.
Post device fabrication coating methods may include, but are not limited to, spin coating, RF-plasma polymerization, dipping, spraying, brushing, submerging the device into a beaker containing a therapeutic solution while inside a vacuum chamber to permeate the device material, etc.
A reinforcement element may be partially or completely fabricated from materials that swell or expand when they are exposed to a fluid (e.g., blood, another body fluid, or an infused fluid). These materials may include hydrophilic gels (hydrogels), foams, gelatins, regenerated cellulose, polyethylene vinyl acetate (PEVA), as well as composites and combinations thereof and combinations of other biocompatible swellable or expandable materials.
In some embodiments, a reinforcement element may be permanently or temporarily attached to the inside and/or outside of the heart (Percutaneous Transluminal and Surgical system versions). In some embodiments, a reinforcement element may be deployed using a delivery/deployment device (e.g., endoscope, catheter, or other suitable device). A delivery/deployment device may be advanced to the surface of the ventricle (inside and or outside of the heart).
In some embodiments, a reinforcement element may be employed using implanted marker elements (or other) as a guide. The reinforcement element may be deployed and positioned along the margins of the akinetic/dyskinetic tissue. The margins of the akinetic/dyskinetic tissue may be represented by the marker implants (using fluoroscopy or other suitable visualization method) and or other suitable method.
In some embodiments, a reinforcement element may be attached to a wall of a ventricle. Once a physician is satisfied with the placement of the reinforcement element, the delivery/deployment device may be withdrawn from the body and the access closed.
In some embodiments, a reinforcement element may be permanently or temporarily attached to the heart. For example, the reinforcement element may be removed after the active treatment/stabilization therapy has been completed. Heat and or therapeutic infusion may be made in the area of, and surrounding the, infarcted myocardial tissue, before, during and/or after the attachment of the reinforcement element. Heat methods may include a probe, catheter, or other suitable instrument with the capability to heat selected tissue. Methods of heating may include radio frequency (RF), ultrasound, microwave, laser, heat, localized delivery of chemical or biological agents and light-activated agents, combination or other suitable methods.
In some embodiments, a system for marking and evaluating at least a portion of a heart may include reference markers. Reference markers may be positioned using a deployment device. A deployment device may include a catheter-based version and/or surgical versions.
Reference markers may be positioned in heart tissue. Reference markers may be used to identify the margins between healthy and akinetic or dyskinetic heart tissues. Reference markers may be used to track disease progression. Reference markers may be used as a guide for plication, patch placement, or other reinforcement element location and attachment. Reference markers may be used as a guide to reinforce, support or exclude the akinetic/dyskinetic heart tissue from the healthy tissue.
The reference markers themselves may be in the form of at least one wire, rod, bar, a combination, or other suitable geometry and design. The reference markers may be formed from any material that is able to be visualized using fluoroscopy, ultrasound, MRI, or any other suitable visualization means.
A system may include a deployment device. The deployment device may include a catheter (or surgical instrument) capable of inserting reference markers along the margin between healthy and akinetic/dyskinetic heart tissue. The catheter may have a lumen with at least one preloaded reference marker. The reference marker may be deployed past the distal end of the deployment device, and into the heart tissue. The reference marker may be deployed by way of a proximal thumb-slide attached to a stylet that engages and advanced the proximal end of a reference marker.
The catheter or surgical instrument may include a fixed and or removable device which functions to evaluate adjacent tissue and to assist with the determination as to where the marking implant should be deployed and inserted into the margin tissue.
Akinetic/dyskinetic tissue location techniques may include using anatomical structures (e.g., as a guide), visualization/sensors, reference markers, or a combination of any of these methods. Systems which may be used to accomplish these various methods may include visualization, CARTO XP System (Biosense Webster—3D Ultrasound), fiber optic, fluoroscopic markers, intravascular ultrasound (2D IVUS), or MRI.
Methods may be employed which assist in confirming tissue contact between, for example, tissue and a deployment device and/or reference markers. Tissue contact may be confirmed using, for example, doppler sensor, electrical impedance, and/or ultrasonic transducer.
As noted above, one representative version of the tissue irradiating reinforcement element may apply ionizing radiation to the surface of the infarcted tissue. Optimally, the radiation has a range which extends through the ventricular wall but not significantly beyond. An example of a radioactive source that can apply this type of radiation dosing is a beta particle emitting radioisotope such as phosphorous-32 which has a range of approximately 3.5 mm for 90% of the electrons that it emits. Phosphorous-32 has a half-life of 14.3 days which means that it has a very high rate of specific activity. Even very small amounts of phosphorous-32 can provide a sufficiently high level of irradiation to the myocardial tissue. The radioactive patch would typically be an elongated flexible structure which can be applied in the region and covering the infarcted myocardial tissue. Typically, the radioactive bandage would extend for approximately 1 to 5 mm beyond the infarct area in all directions.
The radioactive patch may include a shield structure which surrounds the thin, elongated radioactive portion thus disallowing stray radiation to any surrounding or adjacent tissue. The purpose of the shield may be to absorb beta particles without the creation of a significant level of bremsstrahlung. Virtually any elastomer may serve that purpose. The shield may be a high density source which is placed to substantially reduce any stray radiation. The shield may typically be formed from a high density metal such as tungsten impregnated into any one of several elastomers. The purpose of the shield would be to absorb any photon emission caused by bremsstrahlung which resulted from a beta particle hitting the nucleus of some atom. If the radioactive source was a low energy x-ray emitter, the radiation shields might be combined into a single shield having a high density metal impregnated into some elastomer. A radiation dose applied to the inside, and or outside of the ventricular wall of between 500 and 3,000 cGy may be sufficient for most applications.
The heart wall reinforcing devices and accessories described herein (with or without modifications) can be used during cardiopulmonary supported, beating heart, stopped heart, open field, closed-chest, minimally invasive, port, endoscopic, laparoscopic and or robotically assisted surgery, any combination thereof, or other cardiovascular technique. The devices detailed in this system overview may be a hand-held device used through a median sternotomy, lateral thoracotomy, intercostals, port-access, mini-sternotomies, other less invasive approaches involving subxiphoid access, inguinal approaches, or sub-thoracic approaches adjacent the diaphragm. Alternatively, the systems described herein may be modified for catheter based applications by elongating the patch deployment shaft, altering the dimensions of the device, and incorporating other features tailored for intravascular access and internal heart deployment and tissue attachment.
In some embodiments, a reinforcing element may be attached to a portion of an external surface of a heart. A reinforcing element may be used to inhibit further deformation of at least a portion of a human heart. The reinforcing element may be positioned over infarcted tissue, coupling the reinforcing element to an external surface of the heart. Coupling the reinforcement element to an external surface of the heart such that a majority or all of the infarcted tissue is covered may inhibit further deformation of the heart. In some embodiments, the reinforcement element may be designed such that it covers all of the infarcted tissue as well as an area surrounding the infarcted tissue. The reinforcement element may extend, for example, 1 to 5 mm beyond the area of the infarcted tissue.
FIG. 34 depicts an embodiment of a human heart 900 including a depiction of infarcted tissue 938 in the shaded area of the heart with a border zone of tissue 940 surrounding the infarcted area of the heart. FIG. 35 depicts an embodiment of a human heart 900 with an area of infarcted tissue 938 as well as a broken line 942 indicating where a reinforcement element may be positioned and/or coupled to.
In some embodiments, upon positioning and coupling a reinforcement element to a portion of a heart, the reinforcement element may be employed to at least partially reshape a portion of the heart. FIG. 36 depicts an embodiment of a human heart 900 with suture or staples (embodiments of a reinforcement element 908) coupled to the heart over infarcted tissue 938. The reinforcement element may be employed to adjust the shape and/or volume of a portion of the heart. For example, the reinforcement element may be composed of sutures, the sutures may be tightened such that the infarcted tissue is drawn together as well as effectively reshaping the heart. FIG. 37 depicts an embodiment of a human heart 900 with suture or staples (embodiments of a reinforcement element 908) coupled to the heart over the infarcted tissue, before and after the infarcted area has been reduced. The outer portion of the shaded area represents the infarcted portion before adjustment 944 using the reinforcement element. The inner portion of the shaded area represents the infarcted portion after adjustment 946 using the reinforcement element (e.g., after the reinforcement element has been activated), “crimping” the infarcted tissue and reshaping the heart.
FIG. 38 depicts an embodiment of a human heart 900 with suture or staples (embodiments of a reinforcement element 908) coupled to the heart over the infarcted tissue 938 before the infarcted area has been reduced. FIG. 38 depicts an embodiment a reinforcement element using elongated members (e.g., sutures, staples) coupled together in a center of the reinforcement element. In this embodiment, radial forces may be used upon activation of the reinforcement element to reshape the heart.
FIGS. 39-42 depict different embodiments of reinforcement elements 908. FIG. 39 depicts an embodiment of a patch 908 including openings 948. Elongated members (e.g., sutures, staples) may be positioned (e.g., looped) through the openings in the reinforcement element and subsequently activated such that the heart is reshaped. FIG. 40 depicts an embodiment of a wire mesh patch 908. The wire mesh patch may include mechanisms to activate the patch such that the patch exerts pressure or force on the tissue it is coupled to such that the heart is reshaped. FIG. 41 depicts an embodiment of a patch 908 including coupling mechanisms. The coupling mechanisms may include barbs, hooks, and/or anchors.
In some embodiments, mechanisms used in combination with a reinforcement element may be used to assist in reshaping at least a portion of a heart. FIG. 42 depicts an embodiment of a patch 908 including an inflatable/expandable portion 950. In some embodiments a reinforcement element may include an inflatable portion. The inflatable portion may be positioned between the outer surface of the patch and the infarcted heart tissue. The reinforcement element may include an inflation mechanism 952 which functions to inflate the inflatable portion upon activation.
US9498584 * Oct 22, 2013 Nov 22, 2016 The Cleveland Clinic Foundation Apparatus and method for targeting a body tissue
US9498585 * Oct 22, 2013 Nov 22, 2016 The Cleveland Clinic Foundation Apparatus and method for targeting a body tissue
US20130123810 * Nov 14, 2012 May 16, 2013 Eleven Blade Solutions, Inc. Tissue repair assembly
US20140114244 * Oct 22, 2013 Apr 24, 2014 Bavaria Medical Technology, Canada Inc. Apparatus and method for targeting a body tissue
US20140114246 * Oct 22, 2013 Apr 24, 2014 Bavaria Medical Technology, Canada Inc. Apparatus and method for targeting a body tissue
US20150132251 * Jan 15, 2015 May 14, 2015 University Of Pittsburgh - Of The Commonwealth System Of Higher Education Biodegradable Elastomeric Patch for Treating Cardiac or Cardiovascular Conditions
US20150374933 * Oct 22, 2013 Dec 31, 2015 Bavaria Medical Technology, Canada Inc. Apparatus and method for targeting a body tissue
CN104720861A * Mar 3, 2015 Jun 24, 2015 上海形状记忆合金材料有限公司 Woven type volume reduction device
CN104936540A * Oct 22, 2013 Sep 23, 2015 美国克里夫兰临床基金会 Apparatus and method for targeting a body tissue
WO2009092021A1 * Jan 16, 2009 Jul 23, 2009 Nidus Medical, Llc Epicardial access and treatment systems
WO2011083460A3 * Jan 3, 2011 Dec 29, 2011 Assis Medical Ltd. Device system and method for reshaping tissue openings
Cooperative Classification A61F2/2487, A61B2017/00615, A61B2017/00579, A61B2017/00243, A61B17/0057, A61B2017/00632, A61B2017/00575, A61F2/2481
European Classification A61F2/24W2, A61F2/24W4, A61B17/00P
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:SURESH, MITTA;REEL/FRAME:017111/0542