Source: https://patents.justia.com/patent/20040199183
Timestamp: 2020-07-07 00:27:45
Document Index: 572530176

Matched Legal Cases: ['art.\n45', 'art.\n48', 'art.\n49', 'art.\n63', 'art.\n66', 'art.\n67']

US Patent Application for Method and apparatus for circulatory valve repair Patent Application (Application #20040199183 issued October 7, 2004) - Justia Patents Search
Justia Patents Clip ApplierUS Patent Application for Method and apparatus for circulatory valve repair Patent Application (Application #20040199183)
[0024] FIG. 10 is a cross-sectional representation across line 10-10 of the adjustable grasper shown in FIG. 9;
[0039] The invention can perhaps be better appreciated by making reference to the drawings. In FIG. 1 a portion of the human heart is depicted showing a mitral valve 10, a left ventricle 12 and the distal end 14 of a grasper apparatus of the invention 16, which has been inserted through an incision 18 in left ventricle 12. Incision 18 is loosely sutured with sutures 20 to loosely hold distal end 18 and to prevent bleeding.
[0069] Alternatively the grasper can be introduced through a similar stab incision performed over the roof of the left atrium. The grasper will cross the valve and then be manipulated to revert to grasp the leaflets from the atrial side and place the suturing device, just as postulated from the transventricular approach. Once adequacy of repair is confirmed, the device is extracted and the atriotomy closed using conventional wound closure techniques.
[0076] Six adult sheep underwent ligation of OM2 and OM3 through a left thoracotomy to induce chronic ischemic MR. After 8 weeks, animals were placed on cardiopulmonary bypass. Using a posterior approach to the left atrium, a bow-tie repair was performed. A posterior suture annuloplasty (DeVega) served as control. Snares were placed on both repairs to allow alternate tightening during measurements. Ten 2-mm piezo-electric crystals were sutured around the MV annulus and at the bases and tips of the papillary muscles. Six crystals were secured to the apex (1), septum (1), and epicardial short axis of the left ventricle (4) for 3-dimensional sonomicrometry array localization (3D-SAL) imaging. 3D-SAL measurements were performed after weaning from cardiopulmonary bypass at baseline and with each type of repair. Echocardiography was used to measure MR, MV area, and fractional shortening. 1 TABLE 1 MR, mitral valve area, and fractional shortening MR FS MVA (cm2 ) Baseline 3.3 0.46 5.4 DeVega 1.4 0.53 3.9 Bow-tie 1.2 0.57 3.3 FS = fractional shortening; MVA = mitral valve area (planimetry). * P = 0.0159 vs. baseline ** P = 0.0079 vs. baseline
[0080] The charts of eleven patients (five males and six females) undergoing mitral valve repair in conjunction with a central leaflet suture (“bow-tie” repair) were reviewed. Patients were operated on between August 1996 and April 1997. Mean age was 68 years (range, 44 to 78). Etiology of mitral regurgitation (MR) was ischemic in nine patients and degenerative in two. Mitral regurgitation was attributed to ischemia if any of the following criteria proposed by Radford et al. was met: (1) rupture of a papillary muscle chord or head (n=3); (2) infarction of the papillary muscle in the absence of leaflet pathology (n=3); (3) clear history of new onset or worsening of mitral regurgitation after documented myocardial infarction (n=3).
[0081] The diagnosis of MR was established by echocardiography in 10/10 patients, and semiquantitatively graded as severe (4+), moderate/severe (3+), mild/moderate (2+), mild (1+), and trace. Left sided cardiac catheterization confirmed the presence of MR in nine patients and the presence of critical coronary artery disease (CAD) invariably involving the circumflex and posterior descending artery territories in all patients with ischemic MR. Preoperative diagnoses and hemodynamics obtained during catheterization are shown in Table 2. All patients were in NYHA class III or IV at the time of surgery. 2 TABLE 2 Preoperative diagnosis and hemodynamics. Patient Diagnosis Age CO PCWP v-wave 1 Unstable angina 59 4.2 30 80 2 CAD/torn post. chord 78 2.4 6 10 3 CAD 74 n/a 14 15 4 CAD/MIx3 64 n/a n/a n/a 5 Unstable angina/MIx2 44 4.0 26 41 6 Ischemic VSD 77 4.0 28 21 7 AI/MR 77 4.5 29 39 8 CAD/APM rupture 67 4.3 27 65 9 CAD/V-tach arrest 71 4.1 20 28 10 Degenerative MR 70 3.5 20 21 11 AMI/PPM rupture 67 4.1 33 60
[0083] With the patient under anesthesia, the valve is visualized on transesophageal echocardiogram (TEE) and the likely mode of failure determined, with special emphasis on the presence of leaflet prolapse and site and direction of the regurgitant jet. After the heart was stopped, a bulb syringe with cold saline is used to distend the left ventricle and confirm the mode of valve failure. A conventional repair using an annuloplasty right is generally performed and the valve is reinspected with saline injection. If the leaflet edges do not oppose each other in a concentric circle parallel to the annuloplasty ring, and continued regurgitation is observed, then a “bow-tie” repair is initiated. If the repair is performed from the transventricular or transaortic exposure, a single figure of eight 4-0 prolene suture is placed without screening leaflet eight 4-0 prolene suture is placed without screening leaflet coaptation. Using a 4-0 prolene suture, the anterior leaflet is attached to the corresponding posterior leaflet at the site of malapposition. The figure of 8 suture is placed through each leaflet just as the edge turns down to attach to the primary chordae. This is usually the most cephalad site where the 2 leaflets would touch during systole and creates the largest area of coaptation possible.
[0085] Six patients were operated on electively for worsening MR leading to intractable congestive heart failure or unstable angina. Four patients underwent emergent operation due to acute worsening of MR secondary to ischemic anterior papillary muscle rupture (n=2), acute MI with cardiogenic shock requiring intraaortic counterpulsation balloon, severe MR and malignant arrhythmias (N=1), and acute worsening of chronic degenerative MR (n=1). One patient had moderate (3+0 MR in association with critical aortic insufficiency. Mean degree of preoperative MR by echo was 3.5±0.7, with mean ejection fraction (EF) of 42%±17%. Nine patients underwent preoperative cardiac catheterization. Mean pulmonary capillary wedge pressure was 23 mmHg±8 mmHg, with mean atrial v-wave of 39 mmHg±25 mmHg; mean CO as measured by thermodilution technique was 3.9 1/min (range 2.4 to 4.5 1/min) (Table 2). Concomitant procedures performed at the time of MR included coronary artery bypass grafting (CABG) in eight patients. Of the two patients with a degenerative etiology of valvular disease, one required aortic valve replacement, whereas the second underwent posterior leaflet quadrangular resection and annuloplasty. Two patients, not included in this series, with end-stage congestive heart failure (CHF) secondary to ventricular dilation had “bow-tie” repairs during partial left ventriculectomy. Nine patients had a posterior ring annuloplasty as primary procedure for treatment of MR (Table 3). One patient required repair of ischemic ventricular septal defect (VSD) through a ventriculotomy, which made insertion of an annuloplasty ring impractical. This patient's mitral valve was successfully repaired with a “bow-tie” alone. A second patient presented with acute MR secondary to rupture of the anterior head of the ppm. Repair of the papillary muscle was performed using pericardial pledgets. Due to the lack of annular dilatation and persistence of MR a “bow-tie” suture was placed without an annuloplasty ring. Control of MR assessed intraoperatively by direct cold saline injection and TEE was satisfactory in all patients. 3 TABLE 3 Operative indications and concomitant procedures Patient Operative indication Other procedures 1 MR, unstable angina CABG, C-E#28 2 Torn post chord, MR Post quad resection, C-E #32 3 CAD, MR CABG, C-E#32 4 CAD, MR CABG, C-E#30 5 Unstable angina, MR CABG, C-E#28 6 Ischemic VSD, MR CABG 7 Critical AI, MR AVR, C-E#30 8 CAD, ALM rupture, MR CABG, C-E#26 9 CAD, MR CABG, C-E#28 10 MR, CHF C-E#30 11 PPM rupture, MR CABG, primary PPM repair
[0086] AVR-aortic Valve Replacement; C-E Cosgrove Ring; CHF Congestive Heart Failure; PPM Posterior Papillary Muscle
[0087] It will thus be seen that the objects set forth above, among those made apparent from the preceding description, are efficiently attained and, since certain changes may be made in the constructions set forth without departing from the spirit and scope of the invention, it is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not in a limiting sense.
[0088] It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.
[0089] 4 No. Component 10 mitral valve 12 left ventricle 14 distal end of grasper 16 grasper 18 incision 20 suture 22 anterior leaflet or cusp 24 posterior leaflet or cusp 26 anterior cusp distal section 28 posterior cusp distal section 30 jaw 32 closure loop 36 grasper end 38 percutaneous apparatus 40 jaw 42 joint 44 fastener holder 46 fastener clip 48 jaw 50 grasper end 52 jaw 54 joint 56 valve leaflet 58 protruding grasping surface 60 control number 62 upper anvil 64 lower anvil 66 staple type fastener 68 staple action rod 71 recess 72 anvil slanted surface 80 grasper 81 grasper sheath 82 jaw 84 jaw 86 rod 87 pivot point 88 pivot point 90 rod 92 rod 94 pivot 96 valve leaflet 98 sheath 100 drive mechanism 102 coil fastener 110 grasper device 112 jaw 114 sheath 116 fastener 118 grasping surface 120 leaflet 122 cooperating grasping surface 124 pusher 130 grasper device 132 jaw 134 closure member 136 grasping surface 138 closure crimper 140 rod distal end 142 device rod 144 valve leaflet 150 clip-type closure 152 valve leaflet 156 staple-type closure 158 valve leaflet 160 spiral closure 162 valve leaflet 164 barbed-clip closure 166 valve leaflet
1-28. (cancelled)
29. A method for repairing a circulatory valve having leaflets in a patient suffering from regurgitation or insufficiency, said method comprising the steps of:
(a) grasping two leaflets to immobilize said leaflets, wherein the patient's heart is not stopped; and
30. A method as in claim 29, wherein the patient suffers from insufficiency and the circulatory valve is a venous valve.
31. A method for repairing a circulatory valve having leaflets in a patient suffering from regurgitation or insufficiency, said method comprising the steps of:
(a) providing a grasper capable of grasping and coapting the leaflets of the valve;
(b) grasping and immobilizing the leaflets of the valve; and
(c) inserting a fastener into the leaflets to coapt the leaflets in a position which resolves the regurgitation or insufficiency.
32. A method as in claim 31, wherein the leaflets are grasped and immobilized while the heart is not stopped.
33. A method as in claim 31, wherein the patient suffers from insufficiency and the circulatory valve is a venous valve.
34. A method of repairing a circulatory valve in a patient, the valve having leaflets, the method comprising:
accessing the valve through a blood vessel or through a controlled-bleeding entry site in a wall of the patient's heart;
positioning distal sections of the leaflets together or substantially adjacent each other in a coapted configuration; and
securing the leaflets in the coapted configuration.
35. The method of claim 34, wherein the positioning step comprises grasping an exterior side of each leaflet.
36. The method of claim 34, wherein the distal sections of the leaflets are clamped together in the coapted configuration.
37. The method of claim 34, wherein the leaflets are fixed in opposition in the coapted configuration.
38. The method of claim 34, wherein the step of securing comprises applying a fastener to the leaflets.
39. The method of claim 38, wherein the fastener at least partially penetrates the leaflets.
40. The method of claim 39, wherein the fastener is selected from staples, coils, sutures, dual button fasteners, cufflink-like fasteners and clips.
41. The method of claim 34, wherein the step of securing comprises applying a clip to the leaflets.
42. The method of claim 41, wherein the clip does not fully penetrate the leaflets.
43. The method of claim 41, wherein the clip is U-shaped.
44. The method of claim 34, wherein the valve is in the heart.
45. The method of claim 44, wherein the valve is a mitral valve.
46. The method of claim 44, wherein accessing the valve through a controlled-bleeding entry site comprises placing an instrument through an incision in the heart wall and placing a suture around the incision to control bleeding therethrough.
47. The method of claim 44, wherein the step of accessing comprises positioning an instrument through a vein or artery into the heart.
48. The method of claim 47, wherein the step of accessing comprises introducing the instrument through an interatrial septum in the heart.
49. The method of claim 44, wherein the patient is off bypass during each step.
50. A method of repairing a circulatory valve in a patient, the valve having leaflets, the method comprising:
positioning a grasper near the valve through a blood vessel or through a controlled-bleeding entry site in a wall of the patient's heart;
grasping the leaflets with the grasper to position distal sections of the leaflets together or substantially adjacent each other in a coapted configuration; and
51. The method of claim 50, wherein the grasping step comprises grasping an exterior side of each leaflet.
52. The method of claim 50, wherein the distal sections of the leaflets are clamped together in the coapted configuration.
53. The method of claim 50, wherein the leaflets are fixed in opposition in the coapted configuration.
54. The method of claim 50, wherein the step of securing comprises applying a fastener to the leaflets.
55. The method of claim 54, wherein the fastener at least partially penetrates the leaflets.
56. The method of claim 55, wherein the fastener is selected from staples, coils, sutures, dual button fasteners, cufflink-like fasteners and clips.
57. The method of claim 54, wherein the fastener is applied by the grasper.
58. The method of claim 54, wherein the fastener comprises a portion of the grasper.
59. The method of claim 50, wherein the step of securing comprises applying a clip to the leaflets.
60. The method of claim 59, wherein the clip does not fully penetrate the leaflets.
61. The method of claim 59, wherein the clip is U-shaped.
62. The method of claim 50, wherein the valve is in the heart.
63. The method of claim 62, wherein the valve is a mitral valve.
64. The method of claim 62, wherein the grasper is positioned through an incision in the heart wall, the method further comprising placing a suture around the incision to control bleeding therethrough.
65. The method of claim 62, wherein the grasper is positioned through a vein or artery into the heart.
66. The method of claim 62, wherein the grasper is positioned through an interatrial septum in the heart.
67. The method of claim 62, wherein the patient is off bypass during each step.
Publication number: 20040199183
Patent Grant number: 7464712
Inventors: Mehmet C. Oz (Cliffside Park, NJ), Gerald M. Lemole (Huntingdon Valley, PA), Alan Lotvin (Upper Saddle River, NJ), Juan P. Umana (New York, NY), William Allen (Stratford, CT), Howard R. Levin (Teaneck, NJ)
Application Number: 10833659
Current U.S. Class: Clip Applier (606/142); Heart (623/904); Methods (128/898)
International Classification: A61B017/128; A61F002/24;