Source: http://www.google.com/patents/US7275546?dq=system+for+measuring+web+traffic&ei=Lg8FT__TIIr-sQKzxaGRCg
Timestamp: 2014-07-10 07:08:43
Document Index: 421348503

Matched Legal Cases: ['art.\n3', 'art.\n5', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art.2']

Patent US7275546 - Anterior and inferior segment ventricular restoration apparatus and method - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsThe symptoms of congenital heart failure are addressed in this surgical procedure for mounting a patch in the ventricle of the heart to reduce ventricular volume. Placement of the patch is facilitated by palpating a beating heart to identify akinetic, although normal appearing, tissue. An apical patch...http://www.google.com/patents/US7275546?utm_source=gb-gplus-sharePatent US7275546 - Anterior and inferior segment ventricular restoration apparatus and methodAdvanced Patent SearchPublication numberUS7275546 B2Publication typeGrantApplication numberUS 10/811,542Publication dateOct 2, 2007Filing dateMar 29, 2004Priority dateMay 1, 1998Fee statusLapsedAlso published asDE60037182D1, DE60037182T2, EP1148821A1, EP1148821B1, US6221104, US6450171, US20040015046, US20040181126, US20080097147, WO2000042919A1Publication number10811542, 811542, US 7275546 B2, US 7275546B2, US-B2-7275546, US7275546 B2, US7275546B2InventorsGerald D. Buckberg, Constantine L. AthanasuleasOriginal AssigneeBuckberg Gerald D, Athanasuleas Constantine LExport CitationBiBTeX, EndNote, RefManPatent Citations (36), Non-Patent Citations (10), Referenced by (1), Classifications (16), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetAnterior and inferior segment ventricular restoration apparatus and methodUS 7275546 B2Abstract The symptoms of congenital heart failure are addressed in this surgical procedure for mounting a patch in the ventricle of the heart to reduce ventricular volume. Placement of the patch is facilitated by palpating a beating heart to identify akinetic, although normal appearing, tissue. An apical patch having an oval configuration facilitates return of the heart to a normal apical shape which enhances muscle fiber efficiency and a normal writhing pumping action. An inferior patch having a triangular configuration can also be used. The patches include a semi-rigid ring, and a circumferential rim to address bleeding. Patch placement is further enhanced by creating a Fontan-type neck and use of pledged sutures. Intraoperative vascularization and valve replacement is easily accommodated. Increased injection fraction, reduced muscle stress, improved myocardial protection, and ease of accurate patch placement are all achieved with this procedure.
1. A method for restoring the ventricular architecture of a heart having an anterior wall and an inferior wall, comprising the steps of:
creating an incision in the inferior wall of the heart to expose an inner surface of the ventricle of the heart;
forming a suture line around the inner surface of the inferior wall;
providing a ventricular patch having a sheet of biocompatible material and a triangular continuous ring fixed to the sheet and defining a central area of the patch inwardly of the ring and an outer rim of the patch outwardly of the ring;
sewing the continuous ring to the inner surface of the inferior wall so that the central area of the patch defines a portion of the ventricle of the heart; and
sewing the outer rim to the inner surface of the inferior wall outward of the continuous ring of the patch to inhibit the leakage of blood by the patch.
2. The method recited in claim 1, wherein the inferior wall includes a contracting region and a non-contracting region separated by a zone of separation, and the creating step includes the steps of
creating the incision in the non-contracting region of the inferior wall; and
opening the incision to expose an inner surface of the heart.
3. The method recited in claim 2, wherein the forming step includes the step of forming the suture line generally along the line of separation.
4. The method recited in claim 2, wherein the opening step includes the step of spreading the incision to create a triangular opening extending into the ventricle of the heart.
5. The method recited in claim 2, wherein the outer rim of the patch includes a generally constant width around the ring.
6. The method recited in claim 1, wherein the outer rim of the patch includes a generally constant width around the ring.
7. The method of claim 1, wherein the sheet of biocompatible material is in the shape of a triangle.
8. A method for restoring the ventricular architecture of a heart having an anterior wall and an inferior wall, comprising the steps of:
providing a ventricular patch including a sheet of biocompatible material with a continuous ring in the shape of a triangle fixed to the sheet and defining a central area of the patch inwardly of the ring and an outer rim of the patch outwardly of the ring;
sewing the ventricular patch to the inner surface of the ventricle so that the central area of the patch defines a portion of the ventricle of the heart; and
sewing the outer rim to the inner surface of the ventricle outward of the defined portion of the ventricle of the heart to inhibit blood from leaking from the ventricle.
9. The method of claim 8, wherein the outer rim of the patch includes a generally constant width around the central area of the patch.
10. The method of claim 8, wherein the sheet of biocompatible material is in the shape of a triangle.
11. A method for restoring the ventricular architecture of a heart having an anterior wall and an inferior wall, comprising the steps of:
providing a ventricular patch including a sheet of biocompatible material with a continuous ring of pliable material in a non-circular shape fixed to the sheet and defining a central area of the patch inwardly of the ring and an outer rim of the patch outwardly of the ring;
sewing the ventricular patch to the inner surface of the ventricle with first sutures so that the central area of the patch defines a portion of the ventricle of the heart; and
sewing the outer rim to the inner surface of the ventricle with second sutures outward of the first sutures and outward of the portion of the ventricle of the heart to inhibit blood from leaking from the ventricle.
CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 10/216,348, filed Aug. 9, 2002 now abandoned, which is a continuation of U.S. patent application Ser. No. 09/689,254, filed Oct. 11, 2000, U.S. Pat. No. 6,450,171, which is a continuation of U.S. patent application Ser. No. 09/235,664, filed Jan. 22, 1999, U.S. Pat. No. 6,221,104, which is a continuation-in-part of U.S. patent application Ser. No. 09/071,817, filed May 1, 1998, U.S. Pat. No. 6,024,096.
SUMMARY OF THE INVENTION The procedure of the present invention is preferably performed on a beating heart. This is believed to greatly improve the myocardial protection during the restoration process. The procedure further benefits from the beating of the heart by providing a palpable indication of preferred patch placement. As opposed to prior procedures, the primary intent is to exclude, not only the budging dyskinetic segments, but also the non-contracting akinetic segments of the heart which do not contribute to the pumping action. As a result, akinetic segments, despite a normal visual appearance, can be included for exclusion in this procedure. The process may include an endoventriclar Fontan suture, but the stitch will typically be placed in normal tissue with palpable guidance rather than in scar tissue and only a visual determination.
For inferior infarction, the endoventricular suture is placed to reform the triangle (i.e. septum, apex, inferior wall) that becomes enlarged by the noncontractile muscle after infarction. This muscle can either appear normal, be scarred trabecularly, or scarred completely to diverge from the normal triangular smaller size configuration. The intent is to �retriangulate� the inferior wall to its more normal configuration.
The use of a conical apical patch may avoid closure of the muscle of the excluded area over the patch to thereby allow the normal re-configuration to occur. For this reason, it may be desirable to make the rim of the patch (the border that is not connected to the interventricular chain) to be relatively wide. In this case, a 1-2 centimeter size will typically allow the material surface (i.e. pericardium fascia or other soft element) to be coated to remaining muscle for hemostatic purposes. Thus, the closure of the muscle over the patch can be avoided without limiting restoration of the apical configuration if bleeding occurs beneath the closed muscle.
FIG. 7 is a axial cross section view of the left ventricle showing the surgeon's hand palpating the mycardium to define an imaginary circumferential line of separation between viable and akinetic tissue;
FIG. 27 is a front elevation view similar to FIG. 26 and illustrating the preferred placement of basting sutures to retriangulate the inferior wall of the heart;
FIG. 28 is a front perspective view of a preferred embodiment of an inferior patch; being sutured to the heart of FIG. 27;
The shape of the normal heart 12 is of particular interest as it dramatically affects the way that the blood is pumped. It will be noted, for example, that the left ventricle 25, which is the primary pumping chamber, is somewhat elliptical, conical or apical in shape in that it is longer than it is wide and descends from a base 35 with a decreasing cross-sectional circumference, to a point or apex 37. The left ventricle is further defined by a lateral ventricle wall 38, and a septum 41 which extends between the atrium 18, 23, and between the ventricles 21, 25. The mitral valve 34 is situated in an antero-ventricular junction which extends laterally between the atrium 18, 23, and ventricles 21, 25. The �base� of the inferior muscle is also in this general location. This wide base 35 extends to the apex 37 on the inferior cardiac surface. In the area of the base 35, the muscle is relatively flat or slightly spherical compared to the curvilinear form in the anterior wall. The muscle fiber orientation is maintained at approximately 60 degrees from base 35 to apex 37 to maintain the torsional gradient which facilitates ejection. This orientation of fibers changes to accentuate ejection, with less twisting at the base 35 and more twisting at the apex 37.
Ventricular volume is not excessive or >100 ml/m2 left ventricular end systolic volume. The akinetic lateral wall may contain non-functional (contractile tissue) that is hibernating. This indicates viable tissue that improves contraction several months after complete revascularization or when ventricular volume is reduced to produce a more normal ventricular contour (i.e. ellipse). This recovery after revascularization can occur only when ventricular volume is not very large, or the left ventricular end systolic volume index >100 m/m2. This aspect of recovery of akinetic hibernating muscle is potentially important when the ventricular shape is changed surgically to go from a sphere (failing heart) to a conical or apical (more normal configuration) contour.
The sheet material 81 can have a generally fiat planar configuration, or can be shaped as a section of a sphere. The spherical shape can be achieved as illustrated in FIG. 12B by fixing the pericardium while it is stretched over a spherical die to form a concave surface 89.
The circumferential cross section view of FIG. 14 illustrates that the ring 87 may be enclosed in a tubular sheath 90 which may be formed from woven Dacron, and incorporated to promote tissue in growth to the patch 72.
It will be appreciated that many variations on these preferred embodiments of the patch 72 will be apparent, each having a generally non-circular sheet material, such as the material 81, and perhaps a somewhat flexible toroid or oval ring 87.
Another method for placement of the interrupted patch suture is illustrated in FIG. 22B. In this view, which is similar to FIG. 21, interrupted sutures 111 are directed through the entire ventricular wall 38 and exit the wall 38 in proximity to the protrusion 76 which forms the Fontan neck 78. These sutures 111 can also be anchored in a pledged strip 113 disposed on the outer surface of the heart 12 to further enhance the anchoring of these sutures 111.
When all of the interrupted sutures 105 have been placed around the circumference of the neck 87, the patch 72 can be moved from its remote location along the sutures 105 and into proximity with the oval neck 78. This step is illustrated in FIG. 22A where the patch 72 is embodied with the concave surface 89 facing the neck 78 and with the ring 87 disposed outwardly of the material 81. After the patch 72 has been moved into an abutting relationship with the neck 78, the interrupted sutures 105 can be tied as illustrated in FIG. 23.
It may be found that muscle function will be restored to some remote areas following the altered ventricular architecture. Although not fully understood, it is believed that this restoration procedure improves remote segmental myocardial contractility by reducing the wall tension and stress in the myocardium due to a reduction in ventricular volume. The stress equation states that�
Stress = P � R 2 ⁢ h where
A further advantage of this procedure relates to the incision 61 in the left ventricle 25 which also provides access to the mitral valve 34. Replacing this mitral valve 34 through the left ventricle 25 is much simpler than the present intra-atrial replacement procedure. Coronary artery bypass grafts also can be more easily accommodated intraoperatively. As a result, all of these repairs can be undertaken with greater simplicity and reduced time. While blood cardioplegia may be advantageously used for revascularization and valvular procedures, it would appear that the restorative procedure is best accomplished with continuous profusion of the beating open heart for cardiac protection.
A procedure similar to that previously discussed with respect to the anterior patch 72 can be used to restore ventricular architecture to the inferior wall 44 of the heart 12. This procedure is illustrated in the progressive views of FIGS. 25-31.
FIG. 25 illustrates the inferior wall 44 after the heart 12 has been lifted from the patient's chest and the apex 37 rotated upwardly, generally about the base 35 of the heart 12. Thus, the base 35 which is normally above the apex 37 is illustrated below the apex 37 in FIG. 25. Extending along the inferior wall 44 is the right coronary artery 120 which branches into the posterior descending artery 122. A blockage or occlusion 126 in the right coronary artery has resulted in ischemia producing a non-contractive region 128 which is illustrated by shading in FIG. 25. It is the purpose of this procedure relating to the inferior wall 44 of the heart to remove the non-contracting muscle of the region 128 from the ventricle and to restore the ventricular architecture as previously discussed.
This procedure is continued as illustrated in FIG. 26 by creating an incision in the inferior wall 44 in order to expose an inner surface 131 of the wall 44 and the interior regions of the left ventricle 25. Opening the incision exposes the septum 41 and an annulus or base 133 associated with the mitral valve 34. The incision will typically be made along the non-contracting region 128 from a papillary muscle 135 near the apex 37 to the annulus 133 of the mitral valve 34.
As the incision is opened and the non-contracting regions 128 on either side are laid back, a line of separation 137 can be located between the non-contracting region 128 and contracting regions designated generally by the reference numeral 140. Basting sutures 142 are placed generally along this line of separation 137. These basting sutures 142 include a base suture 143 which extends between pledgets 146 and 144 along the base 37. Similarly, lateral basting sutures 148 and 157 can be placed to extend along the line of separation 137 between pledgets 153 and 155, and pledgets 157 and 160, respectively. In an preferred orientation, the lateral basting sutures 148 and 157 meet at a basting apex 162 and diverge to individually intersect the basting sutures 142 at the base 37. Thus, the basting sutures 142, 148 and 157 form a triangle along the line of separation 137.
A patch 171 similar to the patch 72 previously discussed can be configured as illustrated generally in FIG. 28. This patch 171 can be formed from a sheet 173 of biocompatible material and a continuous ring 175 such as the ring 87 previously discussed.
With the inferior patch 171, the sheet material 173 can be made of pericardium or Dacron or fascia. The preferred material will be similar to that of the apical patch previously discussed, but can be autogenous, bovine, or porcelain pericardium. The sheet material 173 will preferably have a triangular shape as will the ring 175. In a preferred embodiment, the shape of the ring 175 is geometrically similar to that of the sheet material 173. Thus, when the ring 175 is disposed centrally of the sheet material 173, it defines a central area 177 and a circumferential rim 179 having a generally constant width around the central area 177. In preferred embodiments, the triangular central area 177 will have sizes such as 2�3�1 and 3�4�1. The width of the circumferential rim 179 will typically be in a range between 1 and 2 centimeters.
This patch 171 is particularly adapted for placement across the triangular opening defined by the basting sutures 142, 148 and 151 as illustrated in FIG. 28. In a preferred method, the ring 175 is sewn to the neck formed by the basting sutures 142, 148 and 151 by sutures 180 extending interiorly through pledgets 182. Similar sutures 183 can be placed to extend entirely through the inferior wall 44 and an exterior pericardial strip 184 in proximity to the lateral basting sutures 151.
With the patch 171 thus positioned, as illustrated in FIG. 30, the central area 177 partially defines the left ventricular chamber 25. However, the circumferential rim 179 remains exteriorly of the chamber 25 and extends along the inner surface 131 of the non-contracting region 128.
In a further step of this procedure illustrated in FIG. 30, the circumferential rim 179 can be fixed to the inner surface 131 by a running suture 186. In the manner previously discussed the circumferential rim 179 thus sutured to the non-contracting region 128 will inhibit any bleeding which may result from placement of the basting sutures 142, 148, 151 or the sutures 180 and 183 associated with placement of the patch 171.
As further support for the restoration procedure, a special suture needle is contemplated which has a proximal end and a distal end. The proximal end is generally straight and accounts for more than half of the length of the needle. The distal end is curved along a relatively large radius facilitating initial penetration of the thick heart wall. Placement of suture 183 can be further enhanced by providing in the patch kit a plurality of sizing disks which can be held in proximity to the triangulation suture in order to determine appropriate patch size. With this configuration, the needle can be easily introduced through the thick myocardium, but then pulled along a generally straight path as it is removed interiorly of the ventricle.
It is believed that cardioplegia arrest may be deleterious to ventricular function in the open ventricle because of nonuniform flow distribution. By avoiding this cardioplegia arrest and operating on a beating heart, aortic cross clamping as well as the use of inter-aortic balloons and ventricular assist devices can be avoided. Patch placement can be intraoperatively adjusted guided by echo or radio nucleotide data. Placement of the patch is further simplified by creation of the Fontan neck 78 or triangular neck, and use of interrupted felt or pericardial pledgeted sutures 105. The circumferential rim 93 associated with the patch 72 facilitates bleeding control without distortion of the patch 72. Finally, using a vest-over-pants closure of the excluded ventricle obliterates dead space and provides security against patch leaks and resultant expansion between the site of closure of the ejecting ventricle with the patch, and where the excluded muscle is closed by the excluded ventricle.
If the patch has a conical or elliptical contour, the parts over vent closure is excluded, so that progressive recovery of potentially hibernating muscle (previously akinetic) can occur so that the muscle itself forms the apex. The parts over vent closure may prevent this, and that is the reson for excluding it.
Within these wide objectives and parameters, there will be variations on the structure of the patch and the methods of restoration. Although the non-circular configuration of the sheet material and ring are believed to be critical, the shape of the patch 72 may vary widely to provide the best anatomical fit with the natural shape of the ventricle 25. The sheet material 81 may be composed of a variety of materials, both natural and artificial. These materials may be woven or nonwoven to achieve a desired structure for the sheet material 81. The ring 87 may similarly be formed from a variety of materials and provided with a variety of shapes in order to add structure to the patch 72 without interfering with the normal contractions of the heart 12. Variations of the steps of the associated restoration method might include mounting the patch with a convex surface facing the ventricular cavity, use of tissue adhesives are also contemplated for attaching sealing and otherwise fixing the patch 72 to the Fontan neck 78 or the triangular neck.
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