|Publication number||US20040098042 A1|
|Application number||US 10/453,709|
|Publication date||May 20, 2004|
|Filing date||Jun 3, 2003|
|Priority date||Jun 3, 2002|
|Also published as||CA2486919A1, CA2486919C, EP1509144A1, EP1509144A4, US20070198060, US20130253538, WO2003101312A1, WO2003101312B1|
|Publication number||10453709, 453709, US 2004/0098042 A1, US 2004/098042 A1, US 20040098042 A1, US 20040098042A1, US 2004098042 A1, US 2004098042A1, US-A1-20040098042, US-A1-2004098042, US2004/0098042A1, US2004/098042A1, US20040098042 A1, US20040098042A1, US2004098042 A1, US2004098042A1|
|Inventors||Carol Devellian, Robert Carr|
|Original Assignee||Devellian Carol A., Carr Robert M.|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (99), Referenced by (21), Classifications (15), Legal Events (4)|
|External Links: USPTO, USPTO Assignment, Espacenet|
 This application incorporates by reference, and claims priority to and the benefit of, U.S. provisional application serial No. 60/385,274, which was filed Jun. 3, 2002.
 The invention generally relates to devices and related methods for treating intracardiac defects. More particularly, the invention provides an intracardiac occluder with a biological tissue scaffold, and related methods, for the percutaneous closure of intracardiac defects.
 The human heart is divided into four compartments or chambers. The left and right atria are located in the upper portion of the heart and the left and right ventricles are located in the lower portion of the heart. The left and right atria are separated from each other by a muscular wall, the intraatrial septum, while the ventricles are separated by the intraventricular septum.
 Either congenitally or by acquisition, abnormal openings, holes, or shunts can occur between the chambers of the heart or the great vessels, causing blood to flow therethrough. Such deformities are usually congenital and originate during fetal life when the heart forms from a folded tube into a four chambered, two unit system. The deformities result from the incomplete formation of the septum, or muscular wall, between the chambers of the heart and can cause significant problems. Ultimately, the deformities add strain on the heart, which may result in heart failure if they are not corrected.
 One such deformity or defect, a patent foramen ovale, is a persistent, one-way, usually flap-like opening in the wall between the right atrium and left atrium of the heart. Since left atrial pressure is normally higher than right atrial pressure, the flap typically stays closed. Under certain conditions, however, right atrial pressure exceeds left atrial pressure, creating the possibility for right to left shunting that can allow blood clots to enter the systemic circulation. This is particularly worrisome to patients who are prone to forming venous thrombus, such as those with deep vein thrombosis or clotting abnormalities.
 Nonsurgical (i.e., percutaneous) closure of patent foramen ovales, as well as similar intracardiac defects such as atrial septal defects, ventricular septal defects, and left atrial appendages, is possible using a variety of mechanical closure devices. These devices, which allow patients to avoid the potential side effects often associated with standard anticoagulation therapies, typically consist of a metallic structural framework that is combined with a synthetic scaffold material. The synthetic scaffold material encourages ingrowth and encapsulation of the device. Current devices typically utilize a polyester fabric, expanded polytetrafluoroethylene (ePTFE), IvalonŽ, or a metal mesh as the synthetic scaffold material. Such devices suffer, however, from several disadvantages, including thrombus formation, chronic inflammation, and residual leaks.
 The present invention provides a device for occluding intracardiac defects. The device includes a biological tissue scaffold, as opposed to a synthetic scaffold (e.g., a polyester fabric, ePTFE, IvalonŽ, or a metal mesh) as presently used by devices known in the art. In a preferred embodiment, the biological tissue scaffold is fabricated from collagen. In one embodiment, a specific type of biological tissue, derived from the tunica submucosa layer of the porcine small intestine, forms the tissue scaffold. As a result of this structure, the aforementioned disadvantages associated with the devices known in the art are minimized or eliminated.
 In one aspect, the invention provides an intracardiac occluder for percutaneous transluminal treatment of an intracardiac defect. The intracardiac occluder includes a proximal support structure supporting a proximal occlusion shell and a distal support structure supporting a distal occlusion shell. The distal support structure is coupled to the proximal support structure and at least one of the occlusion shells includes a biological tissue scaffold.
 Various embodiments of this aspect of the invention include the following features. The biological tissue scaffold may be a purified bioengineered type 1 collagen that may be derived from a tunica submucosa layer of a porcine small intestine. Further, in one embodiment, at least one of the support structures includes a corrosion resistant metal. Alternatively, at least one of the support structures includes a bioresorbable polymer or a biodegradable polymer. In yet another embodiment, the proximal support structure includes a plurality of outwardly extending proximal arms and the distal support structure includes a plurality of outwardly extending distal arms.
 In another aspect, the invention provides a method for percutaneous transluminal treatment of an intracardiac defect in a patient. The method includes providing an intracardiac occluder as described above, positioning the intracardiac occluder proximate the intracardiac defect, and engaging the intracardiac defect with the intracardiac occluder to substantially occlude the intracardiac defect.
 In one embodiment of this aspect of the invention, the intracardiac defect is engaged by positioning the proximal occlusion shell and the distal occlusion shell on different sides of the intracardiac defect. The intracardiac defect may be, for example, a patent foramen ovale, an atrial septal defect, a ventricular septal defect, or a left atrial appendage.
 In yet another aspect, the invention provides a method for making an intracardiac occluder for the percutaneous transluminal treatment of an intracardiac defect. The method includes providing an overall support structure and first and second biological tissue scaffolds. The overall support structure includes a proximal support structure and a distal support structure. The method further includes coupling the first biological tissue scaffold to the proximal support structure and coupling the second biological tissue scaffold to the distal support structure. In various embodiments of this aspect of the invention, the biological tissue scaffolds are sewn, laminated, or glued to the support structures.
 The foregoing and other objects, aspects, features, and advantages of the invention will become more apparent from the following description and from the claims.
 In the drawings, like reference characters generally refer to the same parts throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.
FIG. 1 is a cutaway view of a heart illustrating an intracardiac defect.
FIG. 2A is a top plan view of an intracardiac occluder according to an illustrative embodiment of the invention.
FIG. 2B is a cross-sectional view of the illustrative intracardiac occluder of FIG. 2A.
FIG. 3A is a top plan view of an intracardiac occluder according to another illustrative embodiment of the invention.
FIG. 3B is a side view of the illustrative intracardiac occluder of FIG. 3A.
FIG. 4 is a perspective view of an intracardiac occluder according to another illustrative embodiment of the invention.
 FIGS. 5A-5E illustrate the stages, according to an illustrative embodiment of the invention, for delivering an intracardiac occluder to an anatomical site in the body of a patient.
FIG. 6A illustrates the results from occluding an intracardiac defect with an intracardiac occcluder known in the art, 30-days after delivery of the intracardiac occluder.
FIG. 6B illustrates the results from occluding an intracardiac defect with an intracardiac occluder according to the invention, 30-days after delivery of the intracardiac occluder.
FIG. 7A illustrates the results from occluding an intracardiac defect with an intracardiac occcluder known in the art, 90-days after delivery of the intracardiac occluder.
FIG. 7B illustrates the results from occluding an intracardiac defect with an intracardiac occcluder according to the invention, 90-days after delivery of the intracardiac occluder.
 The present invention provides an intracardiac occluder for the repair of intracardiac defects, such as, for example, a patent foramen ovale, an atrial septal defect, a ventricular septal defect, and left atrial appendages. The intracardiac occluder includes a structural framework and a biological tissue scaffold adhered thereto.
FIG. 1 depicts a cutaway view of a heart 100. The heart 100 includes a septum 104 that divides a right atrium 108 from a left atrium 112. The septum 104 includes a septum primum 116, a septum secundum 120, and an exemplary intracardiac defect 124, which is to be corrected by the intracardiac occluder of the present invention, between the septum primum 116 and the septum secundum 120. Specifically, a patent foramen ovale 124 is shown as an opening through the septum 104. The patent foramen ovale 124 provides an undesirable fluid communication between the right atrium 108 and the left atrium 112. Under certain conditions, a large patent foramen ovale 124 in the septum 104 would allow for the shunting of blood from the right atrium 108 to the left atrium 112. If the patent foramen ovale 124 is not closed or obstructed in some manner, a patient is placed at high risk for an embolic stroke.
FIG. 2A depicts an intracardiac occluder 10 according to an illustrative embodiment of the invention. As shown, the intracardiac occluder 10 includes a proximal occlusion shell 18 (i.e., an occlusion shell that is closest to an operator of the intracardiac occluder 10 (e.g., a physician)), an opposite distal occlusion shell 20, and an overall support structure 16. The overall support structure 16 includes a proximal support structure 24, for supporting the proximal occlusion shell 18, and a distal support structure 34, for supporting the distal occlusion shell 20. In one embodiment, both the proximal support structure 24 and the distal support structure 34 include outwardly extending arms to support each of their respective occlusion shells 18, 20. As shown in FIG. 2A, for example, the proximal support structure 24 includes four outwardly extending arms 26 and the distal support structure 34 similarly includes four outwardly extending arms 36. In one embodiment, each outwardly extending arm is resiliently biased as a result of including three or more resilient coils 43 radially spaced from a center point 45. Alternatively, other resilient support structures could be used. In one embodiment, the eight arms 26, 36 are mechanically secured together by wire 52. Alternatively, other means, such as, for example, laser welding, may be used to secure the eight arms 26, 36 together. A cross-sectional view of the intracardiac occluder 10 illustrated in FIG. 2A, showing four arms 26, 36, is depicted in FIG. 2B.
FIGS. 3A and 3B depict an intracardiac occluder 10′ according to another illustrative embodiment of the invention. An overall support structure 16′ forms a clip and includes a proximal support structure 24′, for supporting a proximal occlusion shell 18′, and a distal support structure 34′, for supporting a distal occlusion shell 20′.
 An intracardiac occluder 10″ according to yet another illustrative embodiment of the invention is illustrated in FIG. 4. Again, an overall support structure 16″ forms a clip and includes a proximal support structure 24″, for supporting a proximal occlusion shell 18″, and a distal support structure 34″, for supporting a distal occlusion shell 20″.
 Alternatively, the overall support structure 16 may assume any shape or configuration to form the proximal support structure 24 and the distal support structure 34.
 In one embodiment, the overall support structure 16 is fabricated from a corrosion resistant metal, such as, for example, stainless steel, nitinol, or a nickel-cobalt-chromium-molybdenum alloy (e.g., MP35N). Alternatively, in other embodiments, the overall support structure 16 is fabricated from bioresorbable or biodegradeable polymers.
 In accordance with the present invention, the occlusion shells 18, 20, which are attached, as described below, to the proximal support structure 24 and the distal support structure 34, respectively, are made from a biological tissue scaffold. In a preferred embodiment, the tissue scaffold is fabricated from collagen. In one embodiment, a purified (acellular) bioengineered type 1 collagen derived from the tunica submucosa layer of the porcine small intestine forms the tissue scaffold. More specifically, the tunica submucosa layer, referred to hereinafter as the Intestinal Collagen Layer (“ICL”), is separated or delaminated from the other layers of the porcine small intestine (i.e., the tunica muscularis and the tunica mucosa) by any method known in the art. For example, a Bitterling sausage casing machine is used to perform the separation. Once mechanically separated from the other layers, the ICL is, in one embodiment, chemically cleaned to remove debris and other substances, other than collagen. For example, the ICL is soaked in a buffer solution at 4 degrees Celsius without the use of any detergents, or, alternatively, in a second embodiment, it is soaked with NaOH or trypsin. Other cleaning techniques known to those skilled in the art may also be used. After cleaning, the ICL is decontaminated. Any sterilization system for use with collagen, as known in the art, may be used. For example, a dilute peracetic acid solution, gamma sterilization, or electron-beam sterilization is used to decontaminate the ICL.
 Alternatively, collagenous tissue from the fascia lata, pericardium, or dura matter of pigs or other mammalian sources, such as, for example, cows or sheep, may form the tissue scaffold. Additionally, in making the occlusion shells 18, 20, two or more collagen layers may be bonded together and then cross-linked to produce a biocompatible material capable of being remodeled by the host cells.
 In one embodiment, the biological tissue scaffold is non-porous and prevents the passage of fluids that are intended to be retained by the implantation of the intracardiac occluder 10. In another embodiment, heparin is ionically or covalently bonded to the biological tissue scaffold to render it non-thrombogenic. In yet other embodiments, proteins or cells are applied to the biological tissue scaffold to render it non-thrombogenic and/or accelerate the healing process. Growth factors may also be applied to the biological tissue scaffold to accelerate the healing process.
 Referring again to FIG. 2A, the occlusion shells 18, 20 are, in one embodiment, generally square in shape. Alternatively, the occlusion shells 18, 20 may assume other shapes. The biological tissue scaffold forming the occlusion shells 18, 20 is strong and flexible. The occlusion shells 18, 20 therefore easily attach to the overall support structure 16 and, as explained below, withstand sheath delivery to an anatomical site in the body of a patient. In one embodiment, the occlusion shells 18, 20 are sewn, as at 22A, 22B, with any commonly used suture material (e.g., a polyester suture) that threads through the distal ends 54 of the respective arms 26, 36 of the proximal support structure 24 and the distal support structure 34. Alternatively, the occlusion shells 18, 20 are laminated, glued, or attached by, for example, hooks or thermal welding to the proximal support structure 24 and the distal support structure 34. In yet another embodiment, the occlusion shells 18, 20 are laminated to the overall support structure 16 and, additionally, to one another, such that the overall support structure 16 is encapsulated entirely within the occlusion shells 18, 20.
 FIGS. 5A-5E depict the stages for delivering the intracardiac occluder 10, according to an illustrative embodiment of the invention, percutaneously to an anatomical site in the body of a patient. Referring to FIG. 5A, a sheath 190 is first inserted into the intracardiac defect 186 as is typically performed by one skilled in the art. The intracardiac occluder 10 is then loaded into the lumen 188 of the sheath 190 and advanced throughout the lumen 188 until positioned at the distal end 192 of the sheath 190. Referring to FIG. 5B, the distal occlusion shell 20 of the intracardiac occluder 10 is released into the distal heart chamber 191 through the distal end 192 of the sheath 190. The distal occlusion shell 20 opens automatically and resiliently. The sheath 190 is then pulled back into the proximal heart chamber 193, as illustrated in FIG. 5C, to seat the distal occlusion shell 20 against the distal wall surface 194 of the intracardiac defect 186. The intracardiac defect 186 is thereby occluded from the distal side. As shown in FIG. 5D, the sheath 190 is then further withdrawn a sufficient distance to allow the proximal occlusion shell 18 to be released from the distal end 192 of the sheath 190. The proximal occlusion shell 18 opens automatically and resiliently to lie against the proximal surface 196 of the intracardiac defect 186, occluding the intracardiac defect 186 from the proximal side. The sheath 190 is then withdrawn from the patient's body, leaving behind the opened intracardiac occluder 10. As shown in FIG. 5E, the occlusion shells 18, 20 are positioned on either side of the intracardiac defect 186 and the intracardiac occluder 10 is permanently implanted within the body of the patient.
 FIGS. 6A-6B and 7A-7B depict comparative 30-day and 90-day results, respectively, for the percutaneous closures of interventionally created intracardiac defects in sheep. Specifically, FIGS. 6A and 7A depict the 30-day and 90-day results, respectively, when an exemplary intracardiac occluder known in the art, whose occlusion shells were fabricated from a polyester fabric (i.e., a synthetic scaffold material), is used to occlude the intracardiac defect. FIGS. 6B and 7B depict the 30-day and 90-day results, respectively, when the intracardiac occluder 10 of the instant invention, whose occlusion shells 18, 20 were fabricated from ICL, is used to occlude the intracardiac defect.
 As shown, the biological tissue scaffold of the intracardiac occluder 10 of the present invention increases the rate of tissue ingrowth and, consequently, decreases the time needed to completely close the intracardiac defect. Specifically, referring now to FIG. 7B, the intracardiac occluder 10 of the present invention is barely visible after 90-days. The surrounding tissue ingrowth nearly completely envelopes the intracardiac occluder 10. In comparison, referring now to FIG. 7A, the exemplary intracardiac occluder known in the art is still clearly visible after the same period of time.
 As also shown, the intracardiac occluder 10 of the present invention naturally adheres to, and seals completely along, the edge of the intracardiac defect in a manner that is much improved from the exemplary intracardiac occluder known in the art. Additionally, in one embodiment, the biological tissue scaffold of the intracardiac occluder 10 of the present invention is non-porous. As a result, the intracardiac occluder 10 decreases the likelihood of fluid (e.g., blood) leakage through the opening.
 Further advantages to the intracardiac occluder 10 of the present invention, in comparison to known intracardiac occluders, include decreased thrombogenicity, quicker endothelialization, superior biocompatibility, minimal foreign body reaction, decreased immunological and inflammatory responses, and no fibrosis.
 Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and the scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description but instead by the spirit and scope of the following claims.
|Cited Patent||Filing date||Publication date||Applicant||Title|
|US621092 *||Aug 25, 1897||Mar 14, 1899||jocelyn|
|US3562820 *||Aug 21, 1967||Feb 16, 1971||Bernhard Braun||Tubular sheet and strip form prostheses on a basis of biological tissue|
|US3874388 *||Feb 12, 1973||Apr 1, 1975||Ochsner Med Found Alton||Shunt defect closure system|
|US3875648 *||Apr 4, 1973||Apr 8, 1975||Dennison Mfg Co||Fastener attachment apparatus and method|
|US4006747 *||Apr 23, 1975||Feb 8, 1977||Ethicon, Inc.||Surgical method|
|US4007743 *||Oct 20, 1975||Feb 15, 1977||American Hospital Supply Corporation||Opening mechanism for umbrella-like intravascular shunt defect closure device|
|US4425908 *||Oct 22, 1981||Jan 17, 1984||Beth Israel Hospital||Blood clot filter|
|US4836204 *||Jul 6, 1987||Jun 6, 1989||Landymore Roderick W||Method for effecting closure of a perforation in the septum of the heart|
|US4902508 *||Jul 11, 1988||Feb 20, 1990||Purdue Research Foundation||Tissue graft composition|
|US4915107 *||Feb 27, 1989||Apr 10, 1990||Harley International Medical Ltd.||Automatic instrument for purse-string sutures for surgical use|
|US5021059 *||May 7, 1990||Jun 4, 1991||Kensey Nash Corporation||Plug device with pulley for sealing punctures in tissue and methods of use|
|US5108420 *||Feb 1, 1991||Apr 28, 1992||Temple University||Aperture occlusion device|
|US5192301 *||Sep 3, 1991||Mar 9, 1993||Nippon Zeon Co., Ltd.||Closing plug of a defect for medical use and a closing plug device utilizing it|
|US5222974 *||Nov 8, 1991||Jun 29, 1993||Kensey Nash Corporation||Hemostatic puncture closure system and method of use|
|US5275826 *||Nov 13, 1992||Jan 4, 1994||Purdue Research Foundation||Fluidized intestinal submucosa and its use as an injectable tissue graft|
|US5282827 *||Mar 5, 1992||Feb 1, 1994||Kensey Nash Corporation||Hemostatic puncture closure system and method of use|
|US5284488 *||Dec 23, 1992||Feb 8, 1994||Sideris Eleftherios B||Adjustable devices for the occlusion of cardiac defects|
|US5304184 *||Oct 19, 1992||Apr 19, 1994||Indiana University Foundation||Apparatus and method for positive closure of an internal tissue membrane opening|
|US5312341 *||Aug 14, 1992||May 17, 1994||Wayne State University||Retaining apparatus and procedure for transseptal catheterization|
|US5312435 *||May 17, 1993||May 17, 1994||Kensey Nash Corporation||Fail predictable, reinforced anchor for hemostatic puncture closure|
|US5411481 *||Oct 27, 1992||May 2, 1995||American Cyanamid Co.||Surgical purse string suturing instrument and method|
|US5413584 *||May 7, 1993||May 9, 1995||Ethicon, Inc.||"Omega"-shaped staple for surgical, especially endoscopic, purposes|
|US5417699 *||Dec 10, 1992||May 23, 1995||Perclose Incorporated||Device and method for the percutaneous suturing of a vascular puncture site|
|US5425744 *||Apr 18, 1994||Jun 20, 1995||C. R. Bard, Inc.||Occluder for repair of cardiac and vascular defects|
|US5433727 *||Aug 16, 1994||Jul 18, 1995||Sideris; Eleftherios B.||Centering buttoned device for the occlusion of large defects for occluding|
|US5480424 *||Nov 1, 1993||Jan 2, 1996||Cox; James L.||Heart valve replacement using flexible tubes|
|US5486193 *||May 1, 1995||Jan 23, 1996||C. R. Bard, Inc.||System for the percutaneous transluminal front-end loading delivery of a prosthetic occluder|
|US5507811 *||Nov 15, 1994||Apr 16, 1996||Nissho Corporation||Prosthetic device for atrial septal defect repair|
|US5540712 *||Jun 1, 1994||Jul 30, 1996||Nitinol Medical Technologies, Inc.||Stent and method and apparatus for forming and delivering the same|
|US5601571 *||May 22, 1995||Feb 11, 1997||Moss; Gerald||Surgical fastener implantation device|
|US5618311 *||Sep 28, 1994||Apr 8, 1997||Gryskiewicz; Joseph M.||Surgical subcuticular fastener system|
|US5620461 *||Jan 5, 1995||Apr 15, 1997||Muijs Van De Moer; Wouter M.||Sealing device|
|US5626599 *||May 1, 1995||May 6, 1997||C. R. Bard||Method for the percutaneous transluminal front-end loading delivery of a prosthetic occluder|
|US5634936 *||Feb 6, 1995||Jun 3, 1997||Scimed Life Systems, Inc.||Device for closing a septal defect|
|US5649950 *||May 1, 1995||Jul 22, 1997||C. R. Bard||System for the percutaneous transluminal front-end loading delivery and retrieval of a prosthetic occluder|
|US5709707 *||Nov 19, 1996||Jan 20, 1998||Children's Medical Center Corporation||Self-centering umbrella-type septal closure device|
|US5711969 *||Apr 7, 1995||Jan 27, 1998||Purdue Research Foundation||Large area submucosal tissue graft constructs|
|US5720754 *||Apr 28, 1995||Feb 24, 1998||Medtronic, Inc.||Device or apparatus for manipulating matter|
|US5725552 *||May 14, 1996||Mar 10, 1998||Aga Medical Corporation||Percutaneous catheter directed intravascular occlusion devices|
|US5733294 *||Feb 28, 1996||Mar 31, 1998||B. Braun Medical, Inc.||Self expanding cardiovascular occlusion device, method of using and method of making the same|
|US5733337 *||Apr 7, 1995||Mar 31, 1998||Organogenesis, Inc.||Tissue repair fabric|
|US5741297 *||Aug 28, 1996||Apr 21, 1998||Simon; Morris||Daisy occluder and method for septal defect repair|
|US5776162 *||Jan 3, 1997||Jul 7, 1998||Nitinol Medical Technologies, Inc.||Vessel implantable shape memory appliance with superelastic hinged joint|
|US5855614 *||May 7, 1996||Jan 5, 1999||Heartport, Inc.||Method and apparatus for thoracoscopic intracardiac procedures|
|US5861003 *||Oct 23, 1996||Jan 19, 1999||The Cleveland Clinic Foundation||Apparatus and method for occluding a defect or aperture within body surface|
|US5879366 *||Dec 20, 1996||Mar 9, 1999||W.L. Gore & Associates, Inc.||Self-expanding defect closure device and method of making and using|
|US5885619 *||Sep 16, 1997||Mar 23, 1999||Purdue Research Foundation||Large area submucosal tissue graft constructs and method for making the same|
|US5893856 *||Jun 12, 1996||Apr 13, 1999||Mitek Surgical Products, Inc.||Apparatus and method for binding a first layer of material to a second layer of material|
|US5902319 *||Sep 25, 1997||May 11, 1999||Daley; Robert J.||Bioabsorbable staples|
|US5904703 *||Nov 7, 1997||May 18, 1999||Bard Connaught||Occluder device formed from an open cell foam material|
|US6010517 *||Apr 8, 1997||Jan 4, 2000||Baccaro; Jorge Alberto||Device for occluding abnormal vessel communications|
|US6024756 *||Dec 22, 1998||Feb 15, 2000||Scimed Life Systems, Inc.||Method of reversibly closing a septal defect|
|US6056760 *||Jan 30, 1998||May 2, 2000||Nissho Corporation||Device for intracardiac suture|
|US6077291 *||Nov 26, 1996||Jun 20, 2000||Regents Of The University Of Minnesota||Septal defect closure device|
|US6079414 *||May 7, 1996||Jun 27, 2000||Heartport, Inc.||Method for thoracoscopic intracardiac procedures including septal defect|
|US6080182 *||Dec 19, 1997||Jun 27, 2000||Gore Enterprise Holdings, Inc.||Self-expanding defect closure device and method of making and using|
|US6171329 *||Aug 28, 1998||Jan 9, 2001||Gore Enterprise Holdings, Inc.||Self-expanding defect closure device and method of making and using|
|US6174322 *||Jul 31, 1998||Jan 16, 2001||Cardia, Inc.||Occlusion device for the closure of a physical anomaly such as a vascular aperture or an aperture in a septum|
|US6187039 *||Dec 10, 1997||Feb 13, 2001||Purdue Research Foundation||Tubular submucosal graft constructs|
|US6190353 *||Oct 11, 1996||Feb 20, 2001||Transvascular, Inc.||Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures|
|US6206895 *||Oct 6, 1999||Mar 27, 2001||Scion Cardio-Vascular, Inc.||Suture with toggle and delivery system|
|US6206907 *||May 7, 1999||Mar 27, 2001||Cardia, Inc.||Occlusion device with stranded wire support arms|
|US6206931 *||Aug 22, 1997||Mar 27, 2001||Cook Incorporated||Graft prosthesis materials|
|US6214029 *||Apr 26, 2000||Apr 10, 2001||Microvena Corporation||Septal defect occluder|
|US6217590 *||Jul 15, 1999||Apr 17, 2001||Scion International, Inc.||Surgical instrument for applying multiple staples and cutting blood vessels and organic structures and method therefor|
|US6228097 *||Jan 22, 1999||May 8, 2001||Scion International, Inc.||Surgical instrument for clipping and cutting blood vessels and organic structures|
|US6245080 *||Sep 22, 2000||Jun 12, 2001||Scion Cardio-Vascular, Inc.||Suture with toggle and delivery system|
|US6334872 *||Jul 7, 1997||Jan 1, 2002||Organogenesis Inc.||Method for treating diseased or damaged organs|
|US6342064 *||Dec 22, 1999||Jan 29, 2002||Nipro Corporation||Closure device for transcatheter operation and catheter assembly therefor|
|US6344049 *||Sep 12, 2000||Feb 5, 2002||Scion Cardio-Vascular, Inc.||Filter for embolic material mounted on expandable frame and associated deployment system|
|US6346074 *||Jun 12, 1996||Feb 12, 2002||Heartport, Inc.||Devices for less invasive intracardiac interventions|
|US6348041 *||Mar 29, 2000||Feb 19, 2002||Cook Incorporated||Guidewire|
|US6352552 *||May 2, 2000||Mar 5, 2002||Scion Cardio-Vascular, Inc.||Stent|
|US6355052 *||Feb 4, 1997||Mar 12, 2002||Pfm Produkte Fur Die Medizin Aktiengesellschaft||Device for closure of body defect openings|
|US6364853 *||Sep 11, 2000||Apr 2, 2002||Scion International, Inc.||Irrigation and suction valve and method therefor|
|US6375625 *||May 11, 2001||Apr 23, 2002||Scion Valley, Inc.||In-line specimen trap and method therefor|
|US6375671 *||Apr 17, 2000||Apr 23, 2002||Nipro Corporation||Closure device for transcatheter operations|
|US6379342 *||Apr 2, 1999||Apr 30, 2002||Scion International, Inc.||Ampoule for dispensing medication and method of use|
|US6379368 *||May 13, 1999||Apr 30, 2002||Cardia, Inc.||Occlusion device with non-thrombogenic properties|
|US6387104 *||Nov 12, 1999||May 14, 2002||Scimed Life Systems, Inc.||Method and apparatus for endoscopic repair of the lower esophageal sphincter|
|US6398796 *||Jan 10, 2001||Jun 4, 2002||Scion Cardio-Vascular, Inc.||Suture with toggle and delivery system|
|US6402772 *||Oct 17, 2001||Jun 11, 2002||Aga Medical Corporation||Alignment member for delivering a non-symmetrical device with a predefined orientation|
|US6551344 *||Jan 12, 2001||Apr 22, 2003||Ev3 Inc.||Septal defect occluder|
|US6712836 *||May 12, 2000||Mar 30, 2004||St. Jude Medical Atg, Inc.||Apparatus and methods for closing septal defects and occluding blood flow|
|US6726696 *||Jun 28, 2002||Apr 27, 2004||Advanced Catheter Engineering, Inc.||Patches and collars for medical applications and methods of use|
|US20020010481 *||Dec 20, 2000||Jan 24, 2002||Swaminathan Jayaraman||Occlusive coil manufacture and delivery|
|US20020019648 *||Apr 18, 2001||Feb 14, 2002||Dan Akerfeldt||Intra-arterial occluder|
|US20020026208 *||Dec 7, 2000||Feb 28, 2002||Medical Technology Group, Inc.||Apparatus and methods for delivering a closure device|
|US20020029048 *||Aug 31, 2001||Mar 7, 2002||Arnold Miller||Endovascular fastener and grafting apparatus and method|
|US20020032462 *||Jun 10, 1999||Mar 14, 2002||Russell A. Houser||Thermal securing anastomosis systems|
|US20020043307 *||Oct 23, 2001||Apr 18, 2002||Kiyoshito Ishida||Core wire for a guide wire comprising a functionally graded alloy|
|US20020052572 *||Sep 25, 2001||May 2, 2002||Kenneth Franco||Resorbable anastomosis stents and plugs and their use in patients|
|US20020077555 *||Jun 8, 2001||Jun 20, 2002||Yitzhack Schwartz||Method for anchoring a medical device between tissue|
|US20030028213 *||Jul 30, 2002||Feb 6, 2003||Microvena Corporation||Tissue opening occluder|
|US20030045893 *||Sep 6, 2001||Mar 6, 2003||Integrated Vascular Systems, Inc.||Clip apparatus for closing septal defects and methods of use|
|US20030050665 *||Sep 7, 2001||Mar 13, 2003||Integrated Vascular Systems, Inc.||Needle apparatus for closing septal defects and methods for using such apparatus|
|US20030059640 *||Aug 2, 2002||Mar 27, 2003||Denes Marton||High strength vacuum deposited nitinol alloy films and method of making same|
|US20030065379 *||Nov 4, 2002||Apr 3, 2003||Babbs Charles F.||Reduction of stent thrombogenicity|
|US20030100920 *||Sep 4, 2002||May 29, 2003||Akin Jodi J.||Devices and methods for interconnecting conduits and closing openings in tissue|
|Citing Patent||Filing date||Publication date||Applicant||Title|
|US7794474||Mar 21, 2002||Sep 14, 2010||The Trustees Of Columbia University In The City Of New York||Endovascular flexible stapling device|
|US7811297 *||Dec 8, 2006||Oct 12, 2010||Teledyne Scientific & Imaging, Llc||Actuable structures and methods of fabrication and use|
|US8025495||Aug 27, 2007||Sep 27, 2011||Cook Medical Technologies Llc||Apparatus and method for making a spider occlusion device|
|US8029532||Oct 9, 2007||Oct 4, 2011||Cook Medical Technologies Llc||Closure device with biomaterial patches|
|US8048110||Jun 24, 2008||Nov 1, 2011||The Trustees Of Columbia University In The City Of New York||Endovascular flexible stapling device|
|US8083768||Dec 27, 2011||Ensure Medical, Inc.||Vascular plug having composite construction|
|US8167905||Jun 17, 2008||May 1, 2012||The Trustees Of Columbia University In The City Of New York||Endovascular flexible stapling device|
|US8308752||Aug 27, 2007||Nov 13, 2012||Cook Medical Technologies Llc||Barrel occlusion device|
|US8480707 *||Jul 31, 2009||Jul 9, 2013||Cook Medical Technologies Llc||Closure device and method for occluding a bodily passageway|
|US8734483 *||Aug 27, 2007||May 27, 2014||Cook Medical Technologies Llc||Spider PFO closure device|
|US8979941 *||Aug 8, 2007||Mar 17, 2015||Coherex Medical, Inc.||Devices for reducing the size of an internal tissue opening|
|US20040230185 *||Feb 25, 2004||Nov 18, 2004||Cierra, Inc.||Energy based devices and methods for treatment of patent foramen ovale|
|US20050021016 *||Jun 21, 2004||Jan 27, 2005||Cierra, Inc.||Energy based devices and methods for treatment of anatomic tissue defects|
|US20050034735 *||Sep 18, 2003||Feb 17, 2005||Cierra, Inc.||Methods and apparatus for treatment of patent foramen ovale|
|US20050131401 *||Feb 2, 2005||Jun 16, 2005||Cierra, Inc.||Energy based devices and methods for treatment of anatomic tissue defects|
|US20050131460 *||Feb 7, 2005||Jun 16, 2005||Cierra, Inc.||Methods and apparatus for treatment of patent foramen ovale|
|US20090317441 *||Feb 7, 2007||Dec 24, 2009||Bilbo Patrick R||Bioengineered tissue constructs and cardiac uses thereof|
|US20100145382 *||Feb 16, 2010||Jun 10, 2010||Nmt Medical, Inc.||Tubular patent foramen ovale (pfo) closure device with catch system|
|US20130103061 *||Apr 25, 2013||John Harper||Device and method for treatment of incision or hernia|
|WO2008021969A2 *||Aug 9, 2007||Feb 21, 2008||Coherex Medical Inc||Methods, systems and devices for reducing the size of an internal tissue opening|
|WO2008036478A2 *||Aug 9, 2007||Mar 27, 2008||Coherex Medical Inc||Devices for reducing the size of an internal tissue opening|
|International Classification||A61B17/12, A61B17/08, A61B17/00|
|Cooperative Classification||A61B2017/00606, A61B2017/00575, A61B2017/00592, A61F2310/00365, A61B2017/1205, A61B17/12172, A61B17/12122, A61B17/0057|
|European Classification||A61B17/12P5H, A61B17/12P7W1, A61B17/00P|
|Oct 30, 2003||AS||Assignment|
Owner name: NMT MEDICAL INC., MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DEVELLIAN, CAROL A.;CARR, ROBERT M.;REEL/FRAME:014652/0319;SIGNING DATES FROM 20030930 TO 20031002
|Jul 22, 2009||AS||Assignment|
Owner name: SILICON VALLEY BANK,CALIFORNIA
Free format text: SECURITY AGREEMENT;ASSIGNOR:NMT MEDICAL, INC.;REEL/FRAME:022990/0295
Effective date: 20090626
|Dec 16, 2010||AS||Assignment|
Owner name: NMT MEDICAL, INC., MASSACHUSETTS
Free format text: RELEASE BY SECURED PARTY;ASSIGNOR:SILICON VALLEY BANK;REEL/FRAME:025641/0730
Effective date: 20101215
|Jun 20, 2011||AS||Assignment|
Owner name: W.L. GORE & ASSOCIATES, INC., ARIZONA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:NMT MEDICAL, INC. (BY AND THROUGH JOSEPH F. FINN, JR., ASASSIGNEE FOR THE BENEFIT OF CREDITORS OF NMT MEDICAL, INC.);REEL/FRAME:026503/0273
Effective date: 20110616