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EP0357338A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

Peripheral cardiopulmonary bypass and coronary reperfusion system

Assignee: Shiley Inc
•
Filing: 1989-08-24
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Granted: —
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Expires: 2009-08-24
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Abstract

Abstract An apparatus and system to arrest or reverse heart damage from myocardial infarction by using a peripheral, femoral-femoral full bypass along with the venting of the left ventricle wherein the rate at which blood is drawn from the femoral vein and the rate at which the left ventricle is vented are relate in a predetermined manner. The damaged area is treated with a cardioplegic solution; the blockage causing the heart attack is then removed by a thrombolytic solution or by angioplasty, while blood is prevented from entering the ventricle and from reactivating the heart from its at-rest condition. Normal blood flow is then restored, and the various catheters and bypass mechanisms removed. The system is also useful for peripheral cardiopulmonary bypass systems not involving the application of a cardioplegic solution. The catheters are specially designed for their function.

Inventors

  • 👤 Gerald D. Buckberg
  • 👤 Kenneth A. Jones
  • 👤 James V. Maloney, Jr.
  • 👤 Weldon D. West

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 11:33
CPC Classifications
A; A61; A61M; A61M1/00; A61M1/36; A61M1/3621; A61M1/3613; A61M1/3623; A61M1/3643; A61M1/3644; A61M1/3664; A61M25/00; A61M2025/0001; A61M2025/0003; A61M2205/00; A61M2205/33; A61M2205/3331; A61M2205/3344; A61M2205/3351; A61M2205/3355; A61M2205/36; A61M2205/366

Claims Analysis

Total Claims: 30
Claim 1
Independent Claim 186 words
An extracorporeal bypass apparatus having a venous catheter (10) for insertion into a femoral vein, such catheter being sufficiently long and flexible to reach the atrium area of a patient's heart and an arterial cannula (12), characterized in that there is provided a single pump (18) connected between the venous catheter and the arterial cannula for withdrawing blood from a patient through said venous catheter and pumping it into a patient through the arterial cannula; and a vent catheter (14) for insertion into an artery sufficiently long and flexible to reach the left ventricle of the heart, said vent catheter being connected in parallel with the venous catheter connected to the pump in a manner such that the negative pressure developed by said pump is applied to the venous catheter and the vent catheter, said venous catheter and said pump being constructed such that substantially all of the patient's blood which would normally be returned to the heart is bypassed through the venous catheter, and the blood reaching the left ventricle of the heart is withdrawn through the vent catheter so that the ventricle is decompressed.
Claim 2
Dependent Claim 186 words
An extracorporeal bypass apparatus having a venous catheter (10) for insertion into a femoral vein, such catheter being sufficiently long and flexible to reach the atrium area of a patient's heart and an arterial cannula (12), characterized in that there is provided a single pump (18) connected between the venous catheter and the arterial cannula for withdrawing blood from a patient through said venous catheter and pumping it into a patient through the arterial cannula; and a vent catheter (14) for insertion into an artery sufficiently long and flexible to reach the left ventricle of the heart, said vent catheter being connected in parallel with the venous catheter connected to the pump in a manner such that the negative pressure developed by said pump is applied to the venous catheter and the vent catheter, said venous catheter and said pump being constructed such that substantially all of the patient's blood which would normally be returned to the heart is bypassed through the venous catheter, and the blood reaching the left ventricle of the heart is withdrawn through the vent catheter so that the ventricle is decompressed.
Claim 3
Dependent Claim 46 words
The apparatus of Claim 1, wherein the negative pressure applied by said pump (18) to the venous catheter (10) and the vent catheter (14) is no greater than 200 mm Hg and said venous catheter can withdraw up to approximately 7 liters per minute of blood.
Claim 4
Dependent Claim 26 words
The apparatus of Claim 1, wherein the flow capacity through the venous catheter (10) is about 15 times greater than that of the vent catheter (14).
Claim 5
Dependent Claim 89 words
The apparatus of Claim 1 wherein said vent catheter (14) is a thin-walled flexible tube which has a coiled distal end (30), which is adapted to conform to a guidewire used in inserting the vent catheter, and a plurality of apertures (32) in the side wall of its distal end, and said catheter includes a pressure lumen (41) extending from the proximal end of the catheter to an inlet (41a) adjacent said apertures, the apertures being between the tip of the catheter and the inlet to the pressure lumen.
Claim 6
Dependent Claim 55 words
The apparatus of Claim 1, including a reservoir (25) having an inlet in communication with the output of said pump (18) and having an outlet in communication with the connection between said venous catheter (10) and said pump, and including means (44, 46) for adjusting the flow of liquid into and out of said reservoir.
Claim 7
Dependent Claim 111 words
The apparatus of Claim 1, including a blood cardioplegia delivery system, further characterized by a cardioplegia delivery pump (24) having an inlet connected to the output of said arterial pump (18); a source of cardioplegic liquid (26) connected as an input to said cardioplegia pump; and a coronary reperfusion catheter assembly including a catheter (16) connected to the output of said cardioplegia pump, the coronary reperfusion catheter being sufficiently long and flexible to be adapted to be inserted through a patient's artery to reach an area of the heart that has been deprived of blood so that a cardioplegia solution can be applied to that area before resuming normal blood flow.
Claim 8
Dependent Claim 44 words
The apparatus of Claim 6, wherein said reperfusion catheter assembly includes a guidewire (34) adapted to guide the reperfusion catheter through said area, and a guide catheter (62) through which said reperfusion catheter is inserted in reaching a point just short of said area.
Claim 9
Dependent Claim 21 words
The apparatus of Claim 1, wherein said venous catheter is made of ethylene-vinyl-acetate material with a thin-walled construction that resists kinking.
Claim 10
Dependent Claim 149 words
A percutaneous cardiopulmonary bypass apparatus, characterized in that there is provided a venous catheter (10) for insertion into a femoral vein; an arterial cannula (12) for insertion into an artery; an oxygenator (20); a pump (18) connected between the venous catheter and the oxygenator for withdrawing blood from a patient through said venous catheter and pumping it through the oxygenator and the arterial cannula into a patient; bridging non-dynamic reservoir (25) having an inlet connected to the output of said pumps and an outlet connected to the inlet of said pump; said catheter being sufficiently long and flexible to reach the atrium area of a patient's heart, said catheter having an interior diameter large enough to permit blood flow of 7 liters per minute with a negative pressure provided by said pump being no greater than 200 mm Hg, and said catheter being thin-walled, but non-kinkable with normal handling.
Claim 11
Dependent Claim 149 words
A percutaneous cardiopulmonary bypass apparatus, characterized in that there is provided a venous catheter (10) for insertion into a femoral vein; an arterial cannula (12) for insertion into an artery; an oxygenator (20); a pump (18) connected between the venous catheter and the oxygenator for withdrawing blood from a patient through said venous catheter and pumping it through the oxygenator and the arterial cannula into a patient; bridging non-dynamic reservoir (25) having an inlet connected to the output of said pumps and an outlet connected to the inlet of said pump; said catheter being sufficiently long and flexible to reach the atrium area of a patient's heart, said catheter having an interior diameter large enough to permit blood flow of 7 liters per minute with a negative pressure provided by said pump being no greater than 200 mm Hg, and said catheter being thin-walled, but non-kinkable with normal handling.
Claim 12
Dependent Claim 79 words
The apparatus of Claim 9, wherein said catheter (10) is made of ethylene-vinyl-acetate, is a French 26 size, has an inner diameter of about than 7 mm and has a plurality of holes (28) in its side wall extending from the distal end of the tip (27) far enough to not only draw blood from the atrium area of the heart, but to also draw blood from the portion of the vein draining the lower portion of the body.
Claim 13
Dependent Claim 143 words
A catheter (14) for use in decompressing a patient's heart in a peripheral system, said catheter characterized by a thin-walled, elongated tube to be inserted into the patient's artery and fed into the patient's heart, the distal end (30) of said tube being sufficiently flexible to permit its presence in the ventricle across the patient's aortic valve without causing distortion of the valve cusps and therefore avoiding valve insufficiency, said distal end having a plurality of openings (32) formed therein to conduct blood out of the patient's ventricle in response to a negative pressure being applied to the proximal end of the catheter, said openings being located in the side walls of said distal end in a pattern to insure that one or more holes will not be blocked by the walls of the ventricle when negative pressure is applied to the catheter.
Claim 14
Dependent Claim 143 words
A catheter (14) for use in decompressing a patient's heart in a peripheral system, said catheter characterized by a thin-walled, elongated tube to be inserted into the patient's artery and fed into the patient's heart, the distal end (30) of said tube being sufficiently flexible to permit its presence in the ventricle across the patient's aortic valve without causing distortion of the valve cusps and therefore avoiding valve insufficiency, said distal end having a plurality of openings (32) formed therein to conduct blood out of the patient's ventricle in response to a negative pressure being applied to the proximal end of the catheter, said openings being located in the side walls of said distal end in a pattern to insure that one or more holes will not be blocked by the walls of the ventricle when negative pressure is applied to the catheter.
Claim 15
Dependent Claim 68 words
The catheter of Claim 11, including an elongated pressure lumen (41) formed in a wall of said tube, said lumen having an inlet (41a) sufficiently close to the distal end (30) of the tube so as to be positioned within the patient's ventricle and extending to the proximal end of the tube with said openings located between said pressure lumen inlet and the distal tip of the catheter.
Claim 16
Dependent Claim 71 words
The catheter of Claim 12, wherein said pressure lumen inlet (41a) is about four inches from the tip of the tube, and wherein said tube is approximately size 15 French with an overall length of about 112 cm, and the interior of said tube is approximately .120 inch, and said openings (32) are approximately .050 inch in diameter and extend over a tube length of about an inch and a half.
Claim 17
Dependent Claim 225 words
Apparatus for withdrawing blood from a patient in a peripheral cardiopulmonary bypass system, characterized in that there is provided: a venous catheter (10) being sufficiently long and flexible to be inserted into a patient's femoral vein and fed through the venous system to the right atrium area of a patient's heart, said catheter having a plurality of openings (28) in its distal end to permit blood to be withdrawn into the catheter, and said catheter having a proximal end adapted to be positioned outside of the patient's body; a vent catheter (14) which is sufficiently long and flexible to be inserted through the patient's vascular system with the distal end (30) of the vent catheter being positioned in the left ventricle of the patient's heart and with the vent catheter having a proximal end located outside of the patient's body, said vent catheter having a plurality of openings (32) in its distal end for permitting blood in the ventricle to be withdrawn through the vent catheter; and tubing including an inlet (29) for connection to the proximal end of said venous catheter, a separate inlet (40) for connection to the proximal end of said vent catheter, and a single outlet in communication with said tubing inlets (29, 40) for connection to the inlet of a pump (18) adapted to apply negative pressure to said catheters.
Claim 18
Dependent Claim 225 words
Apparatus for withdrawing blood from a patient in a peripheral cardiopulmonary bypass system, characterized in that there is provided: a venous catheter (10) being sufficiently long and flexible to be inserted into a patient's femoral vein and fed through the venous system to the right atrium area of a patient's heart, said catheter having a plurality of openings (28) in its distal end to permit blood to be withdrawn into the catheter, and said catheter having a proximal end adapted to be positioned outside of the patient's body; a vent catheter (14) which is sufficiently long and flexible to be inserted through the patient's vascular system with the distal end (30) of the vent catheter being positioned in the left ventricle of the patient's heart and with the vent catheter having a proximal end located outside of the patient's body, said vent catheter having a plurality of openings (32) in its distal end for permitting blood in the ventricle to be withdrawn through the vent catheter; and tubing including an inlet (29) for connection to the proximal end of said venous catheter, a separate inlet (40) for connection to the proximal end of said vent catheter, and a single outlet in communication with said tubing inlets (29, 40) for connection to the inlet of a pump (18) adapted to apply negative pressure to said catheters.
Claim 19
Dependent Claim 80 words
The apparatus of Claim 14, wherein said vent catheter (14) includes a pressure lumen (41) formed in the wall of the vent catheter, with the distal end (41a) of the lumen being adapted to sense pressure within the patient's ventricle when in the ventricle, and the proximal end of the pressure lumen is adapted to be connected to a pressure indicator (39) to monitor the ventricle pressure and to provide an indication of any undesirable pressure build-up within the ventricle.
Claim 20
Dependent Claim 46 words
The apparatus of Claim 14, including a reservoir (25) having an outlet adapted to be connected to said tubing between said tubing outlet and said tubing inlets (29, 40), said reservoir having an inlet adapted to be connected to the outlet side of said pump (18).
Claim 21
Dependent Claim 27 words
The apparatus of Claim 16, including a flow control (44) on the outlet of said reservoir and a flow control (46) on the inlet to said reservoir.
Claim 22
Dependent Claim 135 words
A coronary reperfusion catheter (16) for use in providing cardioplegia to a patient's heart when used in connection with a peripheral cardiopulmonary bypass system, said catheter including a tube sufficiently long and flexible to be adapted to be inserted through an occlusion in the patient's artery to reach an area of the heart that has been deprived of blood so that a cardioplegic solution can be applied to that area before resulting normal blood flow, said tube having a tapered distal end (58) which permits insertion to said area and seals with the occlusion, and said tube having a plurality of holes (60) in said tapered end to permit cardioplegia to be applied to said area, the portion of the tube walls extending between said holes and the proximal end of the tube being imperforate.
Claim 23
Dependent Claim 135 words
A coronary reperfusion catheter (16) for use in providing cardioplegia to a patient's heart when used in connection with a peripheral cardiopulmonary bypass system, said catheter including a tube sufficiently long and flexible to be adapted to be inserted through an occlusion in the patient's artery to reach an area of the heart that has been deprived of blood so that a cardioplegic solution can be applied to that area before resulting normal blood flow, said tube having a tapered distal end (58) which permits insertion to said area and seals with the occlusion, and said tube having a plurality of holes (60) in said tapered end to permit cardioplegia to be applied to said area, the portion of the tube walls extending between said holes and the proximal end of the tube being imperforate.
Claim 24
Dependent Claim 56 words
The catheter of Claim 18, wherein said catheter (16) is about a 4.5 French size and the distal end (58) is of a reduced size of about 3 French, and wherein said holes are abcout .030 inch in diameter and are arranged in a spiral and extend about an inch from the tip of the catheter.
Claim 25
Dependent Claim 105 words
An extracorporeal heart bypass apparatus comprising a venous catheter (29), an arterial cannula (123) and a positive displacement pump (118) connected to apply negative pressure to said catheter to withdraw blood from a patient, characterized in that there is provided a compliance chamber (143) connected between said pump and said catheter to reduce the rate of change of negative pressure applied by said pump on said catheter; and a controller (119) to control the speed of said pump, said controller being responsive to the pressure in said compliance chamber so as to decrease pump speed with an increase in negative pressure in the compliance chamber.
Claim 26
Dependent Claim 105 words
An extracorporeal heart bypass apparatus comprising a venous catheter (29), an arterial cannula (123) and a positive displacement pump (118) connected to apply negative pressure to said catheter to withdraw blood from a patient, characterized in that there is provided a compliance chamber (143) connected between said pump and said catheter to reduce the rate of change of negative pressure applied by said pump on said catheter; and a controller (119) to control the speed of said pump, said controller being responsive to the pressure in said compliance chamber so as to decrease pump speed with an increase in negative pressure in the compliance chamber.
Claim 27
Dependent Claim 60 words
The apparatus of Claim 20, wherein said compliance chamber (143) comprises the space between an expandable reservoir (151) connected between said pump (118) and said catheter (129), and a closed housing (153) surrounding said reservoir wherein the pressure in the chamber being related to the pressure in the reservoir, said controller (119) being responsive to the pressure in said space.
Claim 28
Dependent Claim 28 words
The apparatus of Claim 20, including a pressure transducer sensing the pressure in said space, with the transducer (155) connected to provide its pressure information to said controller.
Claim 29
Dependent Claim 35 words
The apparatus of Claim 20, including a vent catheter (140) connected in parallel to said venous catheter (129) such that the negative pressure provided by said pump (118) is also applied to the vent catheter.
Claim 30
Dependent Claim 48 words
The apparatus of Claim 20, including a reservoir (125) bridging said pump (118) with said bridging reservoir having controls (144, 146) for increasing or decreasing the volume of fluid in the system, with said arterial cannula (123) for conducting the output of said pump to a patient's artery.

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