Source: http://www.google.com/patents/US8073538?dq=5,867,764
Timestamp: 2018-01-21 01:24:45
Document Index: 717571642

Matched Legal Cases: ['art\n1', 'Application No. 200480033455', 'Application No. 200480033455', 'Application No. 07794897', 'Application No. 04', 'Application No. 04', 'Application No. 2006', 'Application No. 04', 'Application No. 04', 'Application No. 200480033455', 'Application No. 200480033455']

Patent US8073538 - Treatment of cardiac arrhythmia by modification of neuronal signaling ... - Google Patents
To control cardiac arrhythmias such as atrial fibrillation post-operatively, various non-ablative agents include polymers, fibroblasts, neurotoxins, and growth factors are introduced into one or more cardiac fat pads into the atrioventricular nodal fat pad in proximity to the autonomic ganglia therein....http://www.google.com/patents/US8073538?utm_source=gb-gplus-sharePatent US8073538 - Treatment of cardiac arrhythmia by modification of neuronal signaling through fat pads of the heart
Publication number US8073538 B2
Application number US 11/803,673
Also published as US8401641, US20080004662, US20120053510
Publication number 11803673, 803673, US 8073538 B2, US 8073538B2, US-B2-8073538, US8073538 B2, US8073538B2
Inventors Nicholas S. Peters, Mark Maciejewski, Todor N. Mazgalev
Original Assignee Cardio Polymers, Inc.
Patent Citations (36), Non-Patent Citations (75), Referenced by (3), Classifications (21), Legal Events (8)
Treatment of cardiac arrhythmia by modification of neuronal signaling through fat pads of the heart
US 8073538 B2
Another type of non-ablative agent is an injectable preparation of a neurotoxin. Useful neurotoxins include botulinum toxins such as Botulinum Type A, which is available from Allergan Inc. of Irvine, Calif. under the name BOTOX® Purified Neurotoxin Complex. Another botulinum toxin well known in the art is Botulinum Type B. We believe that when injected into a fat pad in proximity to a ganglionated plexuses, the botulinum toxin disrupts neuronal signaling in the autonomic ganglia. The effect is temporary, and the neurons generally recover in about three to six months.
Generally, a polymer is considered to be a chain of multiple units or “mers.” A polymer tolerated by the body may be delivered in the vicinity of ganglionated plexuses in the cardiac fat pads, where it primarily mechanically disrupts neuronal signaling. The most likely mechanisms for the intended therapeutic response are that the polymer functions as a mechanical barrier and that the volume of the polymer produces a pressure sufficient to suppress neuronal signaling. For post-operative treatment, a suitable polymer is injectable, illustratively via a standard 23 guage needle. It has a suitable viscosity characteristic or a suitably rapid gelling or solidification characteristic so that it remains generally at the intended location. Its viscosity at time of injection should be acceptable for injection, illustratively less than about 7.5 psi force required on a syringe. Its residence time and stiffness properties should be suitable to maintain suppression of neuronal signaling in the autonomic ganglia for a minimum of about five days, and should experience resorption or dissolution in less than about thirty days without significant metabolic byproducts. Illustratively, it should have a Compressive Modulus (Young's) of between about twelve and forty kPa. Its pH should be physiologic, and it should be sterile. A variety of polymers are suitable. Suitable fibrin sealants are available from a variety of manufacturers, such as Crosseal® and Quixil® fibrin sealant available from Omrix Pharmaceuticals of New York, N.Y., and HemaSeel Fibrin Sealant available from Haemacure Corporation of Sarosota, Fla. A suitable fibrin glue may also be made from cryoprecipitate, which is a source of autologous fibrinogen prepared from a subject's own plasma. Other suitable polymers include synthetic resorbable self-curing hydrogel materials. One such material is DuraSeal® sealant, which is available from Confluent Surgical of Waltham, Mass. The DuraSeal sealant is a polyethylene glycol based sealant. Another such material is CoSeal® surgical sealant, which is available from Angiotech Pharmaceuticals of Vancouver, British Columbia, Canada, and Baxter Healthcare Corporation of Fremont, Calif. The CoSeal surgical sealant is made of two synthetic polyethylene glycols or PEGs, a dilute hydrogen chloride solution, and a sodium phosphate/sodium carbonate solution. At the time of administration, the mixed PEGs and solutions form a hydrogel that adheres to tissue. Both the DuraSeal and CoSeal sealants polymerize within seconds and are broken down in the body within weeks due to hydrolysis. Other suitable polymers include cyanoacrylate glues. Other suitable polymers include polyethylene oxide (“PEO”), PEO-poly-l-lactic acid (“PLLA-PEO block copolymer”), poly(N-isopropylacrylamide-co-acrylic acid) (“poly(NIPAAm-co-Aac)”), a pluronic agent, and poly-(N-vinyl-2-pyrrolidone) (“PVP”). Other suitable polymers include sugars such as monosaccharides, disaccharides, and trisaccharides. A class of materials generally known as alginates are suitable polymers. Other suitable polymer include various beads and hydrogels which may be injected alone to mechanically disrupt neuronal signaling, or with other material to administer therapeutics along with mechanical disruption. The polymer-based beads and hydrogels may contain only polymer material, or may include cells such as stem cells, fibroblasts, or skeletal cells; proteins, plasmids, or genes; growth factors in either protein or plasmid form; chemo-attractants; fibrin factor (or fragment) E; RDG binding sites; various pharmaceutical compositions; neo-tissues; or other therapeutically beneficial materials; or any combination of the foregoing. Suitable polymers for beads and hydrogels include fibrin glue, collagen, alginates, and chitosan. Other suitable polymers include hyaluronic acid, sodium hyaluronate, and other formulations, Restylane Injectable Gel available from Q-Med of Scandinavia or from Medicis Aesthetics Holdings Inc., and Synvisc hyaluronic acid available from Gensyme. The polymer materials described herein generally illustrate certain broader classes of materials, which classes may contribute additional alternatives as would be apparent to one of ordinary skill. Where a compound is herein identified in relation to one or more embodiments described herein, precursors or analogs or derivatives thereof are further contemplated. For example, material structures that are metabolized or otherwise altered within the body to form such compound are contemplated. Or, combination materials that react to form such compound are also contemplated. Additional materials that are also contemplated are those which have molecular structures that vary insubstantial to that of such designated compounds, or otherwise have bioactivity substantially similar thereto with respect to the intended uses contemplated herein (e.g. removing or altering non-functional groups with respect to such bioactive function). Such group of compounds, and such precursors or analogs or derivatives thereof, is herein referred to as a “compound agent.” Similarly, reference herein to other forms of “agents”, such as for example “polymer agent” or “fibrin glue agent” may further include the actual final product, e.g. polymer or fibrin glue, respectively, or one or more respective precursor materials delivered together or in a coordinated manner to form the resulting material.
Eighteen human patients, fifteen of which were men, with a mean age of 66±8 years, a mean Euroscore of 4.1±2.6, and presenting for CABG and/or mitral valve surgery and with no previous history of AF were included in this study. SA and AV fat pads were defined using high frequency stimulation. CM-1 fibrin sealant formulation was injected into the defined fat pads during the planned surgical procedure. All patients underwent continuous cardiac telemetry for 96 hours post-operatively Holter was also obtained 14 and 30 days post-operatively. All 18 patients underwent successful injection of the CM-1 fibrin sealant formulation. Fourteen patients completed the 30 days, and sixteen patients completed the 14 days follow up. No major CM-1 fibrin sealant formulation related side effects were documented. Table 1 demonstrates the study results.
Mean EF (%) 58 ± 11
Combined CABG + mitral valve surgery 2/18 (11%)
Post OP persistent AF requiring none
AF at discharge none
Paroxysmal AF (>30 min duration) 4/18 (22%)
Paroxysmal AF of any duration 6/18 (33%)
Use of antiarrhythmic drug at discharge 1/18 (5.5%)
Control VS 6mA
Baseline 506 1157
Immediate 450 1100
30 min 464 1155
1 hr 30 min 462 756
2 hr 30 mim 469 593
3 hr 464 653
3 hr 30 min 474 678
Control VS 4mA VS 6mA
Baseline 500 564 806
Immediate 500 670 871
1 hr 487 544 990
2 hr 490 532 763
3 hr 520 538 703
4 hr 515 530 684
5 hr 513 512 622
AP AP + VS6mA AP + Vs7mA
Baseline 153 182 213
Immediate 140 180
30 min 155 176 205
1 hr 30 min 153 168 180
2 hr 30 min 157 166 178
3 hr 162 168 170
3 hr 30 min 157 165 174
AP AP + VS 4mA AP + VS 6mA AV block
Baseline 163 185 312 2:1 AVB
Immediate 162 177 250 2:1 AVB
1 hr 163 166 316 (−)
2 hr 163 163 227 (−)
3 hr 166 163 229 (−)
4 hr 164 163 200 (−)
5 hr 165 163 190 (−)
AF AF + VS7mA
Baseline 225 132
Immediate 210
30 min 210 90
1 hr 30 min 220 180
2 hr 30 min 185 156
3 hr 185 150
3 hr 30 min 190 165
AF AF + VS 4mA AF + VS 6mA
Baseline 210 108 48
Immediate 204 126 84
1 hr 216 180 52
2 hr 214 180 108
3 hr 216 180 78
4 hr 216 174 108
5 hr 218 204 120
GROUP <40% ≧40% & <90% ≧90% ANALYZED
Formulation 1 0 (0%) 1 (25%) 3 (75%) 4
Formulation 2 0 (0%) 1 (100%) 0 (0%) 1
Formulation 5 1 (25%) 0 (0%) 3 (75%) 4
Duraseal 0 (0%) 1 (33.3%) 2 (66.7%) 3
CoSeal 0 (0%) 0 (0%) 2 (100%) 2
TisSeel 2 (33.3%) 2 (33.3%) 2 (33.3%) 6
Saline 3 (75%) 1 (25%) 0 (0%) 4
GROUP <2mA >2mA No Induction ANALYZED
Formulation 1 2 (13.3%) 6 (40.0%) 7 (46.7%) 15
Formulation 2 3 (20.0%) 8 (53.3%) 4 (26.7%) 15
Formulation 5 2 (18.2%) 7 (63.6%) 2 (18.2%) 11
Duraseal 0 (0.0%) 5 (35.7%) 9 (64.3%) 14
CoSeal 2 (14.3%) 2 (14.3%) 10 (71.4%) 14
TisSeel 6 (40.0%) 2 (13.3%) 7 (46.7%) 15
Saline 10 (66.7%) 4 (26.7%) 1 (6.7%) 15
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U.S. Classification 607/14, 607/3, 424/78.08, 604/522
International Classification A61K31/74, A61M25/00, A61N1/00
Cooperative Classification A61M2039/1088, A61K38/1825, A61M2039/1083, A61N1/36114, A61M2210/125, A61K35/33, A61M5/19, A61N1/395, A61K38/4893, A61N1/3621
European Classification A61N1/36Z3J, A61K38/18, A61K38/18C, A61K38/48N
Owner name: SYMPHONY MEDICAL INC., CALIFORNIA
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Free format text: CORRECTIVE ASSIGNMENT TO CORRECT THE EXECUTION DATE PREVIOUSLY RECORDED ON REEL 021319 FRAME 0832.ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT OF US APPLICATION NUMBER 11/803,673 FILED ON MAY 15, 2007, FROM NICHOLAS S. PETERS TO SYMPHONY MEDICAL, INC.;ASSIGNOR:PETERS, NICHOLAS S.;REEL/FRAME:028349/0606