Source: https://patents.google.com/patent/US20040181126
Timestamp: 2018-04-19 15:58:14
Document Index: 529233415

Matched Legal Cases: ['art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art 12', 'art.\n4']

US20040181126A1 - Anterior and inferior segment ventricular restoration apparatus and method - Google Patents
US20040181126A1
US20040181126A1 US10811542 US81154204A US2004181126A1 US 20040181126 A1 US20040181126 A1 US 20040181126A1 US 10811542 US10811542 US 10811542 US 81154204 A US81154204 A US 81154204A US 2004181126 A1 US2004181126 A1 US 2004181126A1
US10811542
US7275546B2 (en )
[0029]FIG. 1 is a perspective view of the abdominal cavity of a human body showing the heart in cross section;
[0030]FIG. 2 is a front plan view of the heart showing coronary arteries which feed the septum, apex and lateral wall of the myocardium;
[0031]FIG. 3 is a axial cross section view of the ventricular portions of the heart illustrating a dilated, generally spherical left ventricle;
[0032]FIG. 4 is an anterior elevation view of the heart with an incision into the left ventricle through dyskinetic scar tissue;
[0033]FIG. 5 is an anterior elevation view similar to FIG. 4 where the incision is made in marbled akinetic tissue;
[0034]FIG. 6 is an anterior elevation view similar to FIG. 5 illustrating the incision made in normal-looking akinetic tissue;
[0035]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;
[0036]FIG. 8 is a axial cross section view similar to FIG. 7 illustrating the palpating heart and a preferred zone of placement for a patch associated with the present invention;
[0037]FIG. 9 is an anterior elevation view similar to FIG. 4 and illustrating placement of a Fontan stitch in the ventricular wall;
[0038]FIG. 10 is an axial cross section view taken along lines 10-10 of FIG. 9 and illustrating a Fontan neck created by the Fontan stitch;
[0039]FIG. 11 is a side elevation view of the opening illustrated in FIG. 9 with the Fontan suture tightened to facilitate the natural oval formation of the opening;
[0040]FIG. 12A is a plan view of sheet material included in one embodiment of the patch associated with the present invention;
[0041]FIG. 12B is a cross section view taken along lines 12B-12B of FIG. 12A and illustrating the sheet material in a concave configuration;
[0042]FIG. 13 is a top plan view of a ring associated with the patch of the present invention;
[0043]FIG. 14 is a circumferential cross section taken along lines 14-14 of FIG. 13;
[0044]FIG. 15 is a top plan view showing the sheet material and ring combined to form one embodiment of the patch of the present invention;
[0045]FIG. 16 is a cross section view of the patch taken along lines 16-16 of FIG. 15;
[0046]FIG. 17 is a cross section view similar to FIG. 12B and illustrating the sheet material in a convex configuration;
[0047]FIG. 18 is a cross section view similar to FIG. 16 and illustrating the ring disposed on a concave surface of the sheet material;
[0048]FIG. 19 is a cross section view similar to FIG. 18 and illustrating the ring sandwiched between two pieces of the sheet material;
[0049]FIG. 20 is a cross section view similar to FIG. 19 and illustrating the ring sandwiched between two pieces of material, but having only a single layer in the center of the patch;
[0050]FIG. 21 is an anterior elevation view similar to FIG. 11 and illustrating the placement of pledgeted, interrupted sutures engaging the patch in a remote location;
[0051]FIG. 22A is an axial cross section view of the left ventricle illustrating the patch being moved along the interrupted sutures from the remote location to the Fontan neck;
[0052]FIG. 22B is a perspective view similar to FIG. 21 and illustrating an alternative method for placement of interrupted sutures;
[0053]FIG. 23 is an axial cross section view similar to FIG. 22 and illustrating the patch in its final disposition against the Fontan neck, and further illustrating use of the hemostatic rim to control bleeding;
[0054]FIG. 24 is an axial cross section view of the ventricular portion of the heart, with the patch mounted in place, the ventricle wall restored to its apical configuration, and the lateral ventricular wall closed in overlapping relationship with the septum wall next to the patch;
[0055]FIG. 25 illustrates a front elevation view of the heart after it has been lifted from the chest cavity and its apex has been rotated backwardly about its base to expose the inferior wall of the heart;
[0056]FIG. 26 is a front elevation view similar to FIG. 25 and illustrating an incising step in a method for patching the inferior wall of the heart;
[0057]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;
[0058]FIG. 28 is a front perspective view of a preferred embodiment of an inferior patch; being sutured to the heart of FIG. 27;
[0059]FIG. 29 is a front elevation view similar to FIG. 28 and illustrating final placement of the patch with a circumferential rim extending outwardly of the ventricle along the inner surface of the inferior wall; and
[0060]FIG. 30 is a front elevation view similar to FIG. 29 and illustrating final suturing of the circumferential rim to the inner surface of the inferior wall.
The heart 12 typically includes four chambers, a right auricle 18, a right ventricle 21, a left auricle 23 and a left ventricle 25. In general, the auricles 18 and 23 are receiving chambers which the ventricles 21 and 25 are pumping chambers. Each of these chambers 18-25 is associated with a respective function of the heart 12. For example, it is the purpose of the right auricle 18 to receive the deoxygenated blood returning in the veins of the body 10, such as the femoral vein 27. From the right auricle 18, the deoxygenated blood passes into the right ventricle 21 from which it is pumped through a pulmonary artery 30 to the lungs 14 and 16.
The muscles of the body, of course, include the heart muscle or myocardium which defines the various chambers 18-25 of the heart 12. This heart muscle also requires the nutrients and oxygen of the blood in order to remain viable. With reference to FIG. 2, it can be seen that the anterior or front side of the heart 12 receives oxygenated blood through a common artery 50 which bifurcates into a septal artery branch 52, which is directed toward the septum 41, and an anterior descending artery 54 which is directed toward the apex 37 and the lateral ventricle wall 38.
The body's reaction to ischemic infraction is of particular interest. The body 10 seems to realize that with a reduced pumping capacity, the ejection fraction of the heart is automatically reduced. For example, the ejection fraction may drop from a normal sixty percent to perhaps twenty percent. Realizing that the body still requires the same volume of blood for oxygen and nutrition, the body causes its heart to dilate or enlarge in size so that the smaller ejection fraction pumps about the same amount of blood. As noted, a normal heart with a blood capacity of seventy milliliters and an ejection fraction of sixty percent would pump approximately 42 milliliters per beat. The body seems to appreciate that this same volume per beat can be maintained by an ejection fraction of only thirty-percent if the ventricle 25 enlarges to a capacity of 140 milliliters. This increase in volume, commonly referred to as “remodeling” not only changes the volume of the left ventricle 25, but also its shape. The heart 12 becomes greatly enlarged and the left ventricle 25 becomes more spherical in shape losing its apex 37 as illustrated in FIG. 3. In this view, the stippled area of cross section shows the ischemic or infracted region of the myocardium.
The procedure of the present invention addresses the effects of myocardial infraction using a cardioprotective approach to restore the geometry of the left ventricle. This is not a “remodeling” procedure automatically produced by the body 10, nor a “reconstructive” procedure which leaves the heart with other than a normal geometry. Rather, this is a procedure which attempts to “restore” the normal geometry, and particularly the apical configuration of the left ventricle 25. The procedure reduces the volume of the left ventricle 25, but also increases the percentage of the ventricle wall which is viable. This greatly increases the ejection fraction of the heart and significantly reduces heart stress.
Many variations on the patch 72 will be apparent from the foregoing discussion. For example, as illustrated in FIG. 17, the sheet material 81 can be provided with a convex surface 95 facing the left ventricle 25 rather than the concave surface illustrated in FIG. 13. As illustrated in claim 18, the ring 87 can be disposed on either the interior or exterior side of the material 81.
Another method for placement of the interrupted patch suture is illustrated in FIG. 22B. In this view, which is similar to FIG. 51, 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. 22 where the patch 72 is embodied with the concave surface 90 facing the neck 78 and with the ring 87 disposed outwardly of the material 81. After the patch 17 has been moved into an abutting relationship with the neck 78, the interrupted sutures 105 can be tied as illustrated in FIG. 23.
With the patch 72 suitably placed, the operative site can be closed by joining the myocardial walls in a vest-over-pants relationship as illustrated in FIG. 24. Care should be taken not to distort the right ventricle 21 by folding the septum over the wall 41 ventricular wall 38. Alternatively, the lateral wall 38 can be disposed interiorly of the septum wall 41 so a majority of the force on the patch 72 is diverted to the lateral wall 38. These walls 38 and 41 can be overlapped in close proximity to the patch 72 in order to avoid creating any cavity between the patch 72 and the walls 38, 41. When air evacuation is confirmed by transesophageal echo, the patient can be weaned off bypass usually with minimal, if any, inotropic support. Decanulasation and closure is routine.
[0103]FIG. 24 is positioned in proximity to FIG. 3 in order to illustrate the dramatic difference between the pre-operative dilated heart of FIG. 3 and the post-operative apical heart of FIG. 24. For comparison it will again be noted that the dilated heart of FIG. 3 might typically have a left ventricular volume of 140 milliliters which might produce a blood flow of 42 milliliters with an ejection fraction of 30%. Comparing this with the postoperative heart of FIG. 24, it can be seen initially that the ventricular volume is reduced for example to 90 milliliters. The percentage of viable heart wall as opposed to akinetic heart wall is greatly increased thereby providing an increase in the ejection fraction, for example from thirty percent to forty-five percent. This combination results in a pumped blood volume of about 40 milliliters with each beat of the heart 12.
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
A further advantages 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 value 34 through the left ventricle 25 is much simpler than the present intra-aortic 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.
[0114]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 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 noti-contracting region 128.
a sheet of biocompatible material having a generally planar configurationlin the shape of a first triangle;
the circumferential region of the patch having a generally constant width around the central area of the patch.
3. 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; and
sewing the ventricular patch to the inner surface of the inferior wall along the suture line to restore the ventricular architecture of the heart.
4. The method recited in claim 3, wherein the providing step includes the step of:
forming the ventricular patch to include a sheet of biocompatible material and a continuous ring fixed to the sheet.
5. The method recited in claim 3, wherein the creating step includes the steps of:
creating the incision in a non-contracting region of the inferior walls,
opening the incision to expose an inner surface of the heart, the contracting region being separated from the non-contracting region by a line of separation.
6. The method recited in claim 5, wherein the forming step includes the step of:
forming the suture line generally along the line of separation.
US10811542 1998-05-01 2004-03-29 Anterior and inferior segment ventricular restoration apparatus and method Expired - Fee Related US7275546B2 (en)
US20040181126A1 true true US20040181126A1 (en) 2004-09-16
US7275546B2 US7275546B2 (en) 2007-10-02