WO1999009890A1

WO1999009890A1 - Inflatable heart holder device

Info

Publication number: WO1999009890A1
Application number: PCT/US1998/015829
Authority: WO
Inventors: John D. Puskas
Original assignee: Emory University
Priority date: 1997-08-26
Filing date: 1998-07-29
Publication date: 1999-03-04
Also published as: AU8673098A

Abstract

Inflatable pads (1, 2) of certain shape are provided for holding the heart during surgery, particularly to give access to certain coronary vessels. These pads (1, 2) enable the surgeon to obtain easier access to the heart by placing the pads (1, 2) under the heart during surgery, thereafter inflating the pads (1, 2) in order to turn the heart between about 30 degrees, and about 90 degrees.

Description

INFLATABLE HEART HOLDER DEVICE

FIELD OF THE INVENTION

The present invention relates generally to the field of medical devices for cardiac surgery. The general purpose of this invention is to facilitate access to the coronary arteries during the performance of cardiac surgery. This is accomplished via use of a novel inflatable pad-like device which functions to turn the heart between about 30° and about 90°, to rotate the coronary arteries toward the surgeon.

BACKGROUND OF THE INVENTION

Typically coronary artery bypass graft (CABG) operations are performed by making a median sternotomy, a skin incision extending from the jugular notch to a point inferior to the xiphoid process. Further incision in made though the subcutaneous tissue and fascia to expose the sternal periostium. The sternum is separated longitudinally, and a sternal spreader is put in place. Access to the heart is obtained by opening the pericardium. The aorta and right atrium are cannulated, the patient is placed on cardiopulmonary bypass or heart-lung machine, and the aorta is then cross- clamped. Usually the heart is covered with cold saline and cold cardioplegia is injected into the aortic root. The heart is then manually retracted upward and toward the head. This enables the surgeon to perform a vascular graft to the posterior descending artery or the distal right coronary artery. Further retraction of the heart in a rightward direction is required to make an additional anastomosis to marginal branches of the circumflex coronary artery.

Thus, to obtain proper access to various portions of different coronary arteries at a number of sites on the heart, it is necessary to turn or rotate the heart into the proper position. Typically this is accomplished via vigorous manual retraction. While such retraction is possible and tolerable during cadiopulmonary bypass, it is not hemodynamically tolerated if coronary surgery is performed on the beating heart, i.e., without use of cardiopulmonary bypass and cardioplegic arrest. A newer approach, "beating heart" coronary bypass surgery, offers many advantages to the patient, and is less expensive.

This invention is an inflatable device, which offers the surgeon the considerable advantage of serving to gently hold and rotate the heart toward the midline, thereby enabling the surgeon to see and operate on the desired portion of the heart without vigorous manual retraction of the heart. This rotation is effected by inflation of the device such that the heart is turned typically between about 30° and about 90°. By turning the heart, the inflatable device gives the surgeon easier access to the various coronary arteries located at a number of sites on the epicardium.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1 A schematically illustrates a deflated heart holder in the form of a wedge. Figure IB schematically illustrates an inflated wedge positioned for insertion behind the heart.

Figure 1C schematically illustrates the cross-sectional view through C-C of the inflated heart holder illustrated in Figure IB.

Figure 2A schematically illustrates an inflated heart holder in the form of two attached pillows positioned for insertion behind the heart. Figure 2B schematically illustrates the cross-sectional view through B-B of the inflated heart holder illustrated in Figure 2A.

Figure 3 A schematically illustrates an inflated wedge with recess.

Figure 3B schematically illustrates the cross-sectional view through B-B of the inflated wedge with recess of Figure 3 A.

Figure 4A schematically illustrates an inflated, three chambered wedge with recess, positioned for insertion underneath the apex of the heart.

Figure 4B schematically illustrates an inflated, three chambered wedge with recess, positioned for insertion underneath the left ventricle of the heart.

Figure 4C schematically illustrates the cross-sectional view through C-C of the wedge of Figure 4 A and 4B.

Figure 5 A schematically illustrates a heart holder as a curved wedge with two chambers, which is secured to the heart with attached laces for insertion through the transverse sinus and behind the inferior vena cava.

Figure 5B schematically illustrates the cross-sectional view through B-B of the curved wedge of Figure 5 A.

DETAILED DESCRIPTION OF THE INVENTION The devices of the present invention are especially useful for performance of coronary bypass surgery on the beating heart without the use of cardiopulmonary bypass or cardioplegic arrest. Under these circumstances, vigorous manual retraction of the heart is not tolerated, as it produces hemodynamic instability. Additionally, gentle, controlled elevation and rotation of the heart on the inflatable devices of the present invention will present coronary blood vessels to the surgeon while allowing hemodynamic stability during "off-pump" coronary bypass surgery. This feature is suitable for thoracotomy or sternotomy.

The present invention relates to a device for holding a heart during surgery, comprising:

(a) an inflatable pad having at least two sides, said pad containing one or more chambers; and

(b) for each chamber, a stop cock connected to the inflatable pad by a tube, said device, when fully inflated, capable of turning the heart between about 30° and about 90° .

In one embodiment of the present invention, the inflatable pad is in the shape of a wedge of three sides.

In another embodiment of the present invention, the inflatable pad is in the shape of a curved wedge or quarter moon, with an inner tapering edge and an outer thick edge.

In another embodiment of the present invention, the device is further secured in place during surgery by one or more soft, flexible laces, one lace being secured to each end of the device by attachment means, one such lace threaded through the transverse sinus of the heart, and the other lace threaded under the inferior vena cava, said laces secured to securing means outside the pericardial space.

Heart Holder for Thoracotomy

One method of performing coronary bypass surgery is via an incision between the ribs, a thoracotomy. Access to the surface of the heart in this arrangement is limited typically to the left anterior descending coronary artery and its branches.

In one embodiment of the present invention, a heart holder is designed for the thoracotomy, as illustrated in Figures IB, 2 A, or 3B. This wedge-shaped inflatable device, with or without recess, has approximate dimensions according to the following table.

Dimension Range Preferred Range Preferred Length

Head-tail 15-20 cm 15.5-17 cm 16 cm

Width 6-10 cm 7-9 cm 8 cm

Height (max.) 6-10 cm 7-9 cm 8 cm

The wedge has a head to tail axis, and is typically oriented in the patient during surgery with the head portion of the wedge nearer the head of the patient, the tail portion of the wedge located distally to the head of the patient. The head-tail dimension of the wedge may vary between about 15 cm and about 20 cm, preferably between about 15.5 cm and about 17 cm, most preferably about 16 cm. Likewise with the width and height, according to the table above setting forth approximate dimensions. Height dimensions are given as maximum height lengths after substantially complete inflation. It will be understood that the surgeon may prefer to partially inflate the wedge, to height dimensions less than those provided in the Table above, e.g., about 3 or 4 cm. Heart Holder for Sternotomy

Another method of performing coronary bypass surgery is via an incision down the middle of the sternum, followed by spreading apart the opening to access the heart, a sternotomy. This approach allows access to all the coronary arteries, including the left anterior descending coronary artery and its branches, the left circumflex artery, and the right coronary artery.

In one embodiment of the present invention, a heart holder is designed for the sternotomy, as illustrated in Figure 5. This inflatable device is in the shape of a curved wedge or quarter moon or the like, and has approximate dimensions according to the following table.

Dimension Range Preferred Range Preferred Length

Head-tail 16-24 cm 18-22 cm 20 cm

Width 8-12 cm 8-10 cm 9- 10cm

Height (max.) 5-10 cm 7-9 cm 8 cm

The device can be oriented in a head to tail axis, e.g., it can be oriented in the patient during surgery with the head portion of the wedge nearer the head of the patient, the tail portion of the wedge located distally to the head of the patient. The head-tail dimension of the device may vary between about 16 cm and about 24 cm, preferably between about 18 cm and about 22 cm, most preferably about 20 cm. Likewise with the width and height, according to the table above setting forth approximate dimensions. Height dimensions are given as maximum height lengths after substantially complete inflation. It will be understood that the surgeon may prefer to partially inflate the moon-shaped device to height dimensions less than those provided in the Table above, e.g., about 3 or 4 cm

The devices of the present invention are made of any suitable material capable of expanding without stretching under pressurized gas. Rubberized cloth with a velour finish is commonly employed in head rests, and is particularly suitable because of its property of high surface friction when wet. The embodiments illustrated in the present invention are not intended to limit the scope of the invention. For example, baffles can be inserted into the devices at various points, and separately inflated to obtain finer control of the inflation process. To each air compartment is attached tubing, a stopcock or other switch means, and a source of pressurized air. According to one embodiment of the present invention, the heart holder is an inflatable pad in the form of a wedge of two air chambers, as illustrated by way of example in Figures 1A, IB and IC. This shape is preferably used in thoracotomies. Figure 1 A shows a deflated version, Figure IB an inflated version positioned for insertion behind the left ventricle of the heart. A cross-sectional view at C-C is shown in Figure IC. An upper chamber 1 and lower chamber 2 are joined, each chamber separately inflatable with an air source attached through tubing 3. The surgeon can readily manipulate the degree of inflation of each chamber separately, e.g., through attached valves 5. Once positioned behind the left ventricle, shown in the phantom line of the heart 6, the heart rests on the support surface 4, and thereby is turned between about 30° and about 90°. According to another embodiment of the present invention, the heart holder is an inflatable pad in the form of a pillow of two air chambers, as illustrated by way of example in Figures 2 A and 2B. This shape is preferably used in thoracotomies. Figure 2 A shows an inflated version positioned for insertion behind the left ventricle of the heart. A cross- sectional view at B-B is shown in Figure 2B. An upper chamber 1 and lower chamber 2 are joined, each chamber separately inflatable with an air source attached through tubing 3. The surgeon can readily manipulate the degree of inflation of each chamber separately, e.g., through attached valves (not shown). Once positioned behind the left ventricle, shown in the phantom line of the heart 6, the heart rests on the support surface, and thereby is turned between about 30° and about 90°.

According to another embodiment of the present invention, the heart holder is an inflatable pad in the form of a wedge of two air chambers with a recess or concavity adapted to the shape of the heart, as illustrated by way of example in Figures 3 A and 3B. This shape is preferably used in thoracotomies. Figure 3 A shows an inflated version positioned for insertion behind the left ventricle of the heart. A cross-sectional view at B-B is shown in Figure 3B. An upper chamber 1 and lower chamber 2 are joined, each chamber separately inflatable with an air source attached through tubing 3. The surgeon can readily manipulate the degree of inflation of each chamber separately, e.g., through attached valves 5. Once positioned behind the left ventricle, shown in the phantom line of the heart 6, the heart rests on the recess 7 of the support surface, and thereby is turned between about 30° and about 90°. According to another embodiment of the present invention, the heart holder is an inflatable pad in the form of a wedge of three air chambers with a recess or concavity adapted to the shape of the heart, as illustrated by way of example in Figures 4 A and 4B. This shape is preferably used in thoracotomies. In this embodiment, the air chambers are transversely oriented. Figure 4A shows an inflated version positioned for insertion behind the apex of the heart. Figure 4B shows an inflated version positioned for insertion behind the left ventricle of the heart. A cross-sectional view at C-C is shown in Figure 4C. Three chambers 8, 9, and 10 are joined, each chamber separately inflatable with an air source attached through tubing 3. The surgeon can readily manipulate the degree of inflation of each chamber separately, e.g., through attached valves (not shown). Once positioned behind the left ventricle, shown in the phantom line of the heart 6, the heart rests on the recess 7 of the support surface, and thereby is turned between about 30° and about 90°.

According to another embodiment of the present invention, the heart holder is an inflatable pad in the form of a curved wedge of two air chambers, as illustrated by way of example in Figures 3 A and 3B. This shape is preferably used in sternotomies. Figure 5A shows an inflated version positioned for insertion behind the left ventricle of the heart. A cross-sectional view at B-B is shown in Figure 5B. An upper chamber 11 and lower chamber 12 are joined, each chamber separately inflatable with an air source attached through tubing 3. The surgeon can readily manipulate the degree of inflation of each chamber separately, e.g., through attached valves (not shown). Once positioned behind the left ventricle, shown in the phantom line of the heart 6, the heart is turned between about 30° and about 90°. To secure placement of the curved wedge during surgery, particularly while the heart is beating, a lace 13 is attached at the head of the curved wedge, to be passed through the transverse sinus of the heart, whereas another lace 14 is attached at the tail of the curved wedge, to be passed under the inferior vena cava. Laces 13 and 14 may then be tied to a securing means located outside of the pericardial space, e.g., surgical equipment such as a sternal retractor.

While the forgoing specification teaches the principles of the present invention, with figures provided for the purpose of illustration, it will be understood that the practice of the invention encompasses all of the usual variations, adaptations, and modifications, as come within the scope of the following claims and its equivalents.

Claims

WHAT IS CLAIMED IS:

1. A device for holding a heart during surgery, comprising:

(b) for each chamber, a stop cock connected to the inflatable pad by a tube, said device, when fully inflated, capable of turning the heart between about 30┬░ and about 90┬░.

2. The device of claim 1, wherein said inflatable pad is in the shape of a wedge of three sides.

3┬╗ The device of claim 1, wherein said inflatable pad is in the shape of a curved wedge, with an inner tapering edge, and an outer thick edge.

4. The device of claims 2 or 3, wherein the device is further secured in place during surgery by one or more soft, flexible laces, one lace being secured to each end of the device by attachment means, one such lace threaded through the transverse sinus of the heart, and the other lace threaded under the inferior vena cava, said laces secured to securing means outside the pericardial space.