Patent US5738652A successfully refreshed from Google Patents.
US5738652A
Expired / Lapsed
US
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Retrograde delivery catheter and method for inducing cardioplegic arrest
Assignee: Edwards Lifesciences LLC
•
Filing: 1997-01-17
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Granted: 1998-04-14
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Expires: 2017-01-17
Abstract
Abstract A retrograde delivery catheter includes at its distal end a balloon configured to occlude the coronary sinus of a patient's heart, and has a length and flexibility which allow the distal end to be positioned in the coronary sinus with the proximal end extending transluminally to a peripheral vein such as an internal jugular vein and out of the body through a puncture therein. The delivery catheter has a delivery lumen extending between its proximal and distal ends which is configured to allow a cardioplegic fluid to be delivered at a flow rate of at least 200 ml/min with a pump pressure less than 300 mm Hg, thereby allowing cardioplegic arrest to be maintained using a blood cardioplegic fluid without causing excessive hemolysis. In a method of inducing cardioplegic arrest according to the invention, the patient is placed on cardiopulmonary bypass, the coronary arteries are isolated from remainder of the arterial system, and the delivery catheter is positioned transluminally in the coronary sinus from a peripheral vein. A cardioplegic fluid is then delivered to the coronary sinus through the delivery catheter at a flow rate of at least 200 ml/min and a pump pressure less than 300 mm Hg. The heart may be vented by withdrawing blood from the pulmonary artery through a catheter introduced through a peripheral vein, or withdrawing blood from the aortic root through an aortic catheter introduced through a peripheral artery.
Inventors
- 👤 Stephen W. Boyd
- 👤 John H. Stevens
- 👤 Philip C. Evard
- 👤 Craig L. Adams
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 13:22
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/28; A61B17/29; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2427; A61F2/243; A61F2/2433; A61M; A61M1/00; A61M1/36; A61M1/3621; A61M1/3653; A61M1/3659; A61M25/00; A61M25/0021; A61M25/0041; A61M25/01; A61M25/0105; A61M25/0133; A61M25/0147; A61M25/0152; A61M25/06; A61M25/0662; A61M25/10; A61B17/32; A61B17/320016; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B18/00; A61B2018/00053; A61B2018/00214; A61B2018/0022; A61B2018/00232; A61B2018/0025; A61B2018/00261; A61F2/2412; A61F2/2436; A61M1/3613; A61M25/0023; A61M25/0026; A61M25/003; A61M2025/0031; A61M2025/004; A61M25/0067; A61M25/0074; A61M25/0075; A61M2025/0076; A61M2025/0078; A61M2025/0161; A61M25/02; A61M2025/028; A61M2025/1043; A61M2025/1047; A61M2025/1052; A61M2025/1077; A61M2025/1095; A61M2202/00; A61M2202/04; A61M2202/0468; A61M2202/047; A61M2205/00; A61M2205/11; A61M2205/36; A61M2205/366; A61M2210/00; A61M2210/12; A61M2210/125; A61M2210/127; A61M25/0032; A61M25/0125; A61M25/1002
Claims Analysis
Total Claims: 32
Claim 1
Independent Claim
170 words
A method of inducing cardioplegic arrest of a patient's heart, the heart having an aorta leading away therefrom to a peripheral artery, coronary arteries in communication with the aorta, and a brachiocephalic artery in communication with the aorta downstream from the coronary arteries, the method comprising: providing a retrograde delivery catheter having an occluding member, the occluding member having a collapsed shape and an expanded shape, the retrograde delivery catheter also having a lumen and an outlet positioned distal to the occluding member for delivering a fluid to a patient's coronary sinus; inserting the retrograde delivery catheter through a peripheral vein in the patient; advancing the retrograde delivery catheter transluminally through the vein and into the patient's coronary sinus; expanding the occluding member to thereby occlude the patient's coronary sinus; and delivering a cardioplegic fluid comprising blood and a cardioplegic agent through the retrograde delivery catheter to the coronary sinus at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm Hg.
Claim 2
Independent Claim
170 words
A method of inducing cardioplegic arrest of a patient's heart, the heart having an aorta leading away therefrom to a peripheral artery, coronary arteries in communication with the aorta, and a brachiocephalic artery in communication with the aorta downstream from the coronary arteries, the method comprising: providing a retrograde delivery catheter having an occluding member, the occluding member having a collapsed shape and an expanded shape, the retrograde delivery catheter also having a lumen and an outlet positioned distal to the occluding member for delivering a fluid to a patient's coronary sinus; inserting the retrograde delivery catheter through a peripheral vein in the patient; advancing the retrograde delivery catheter transluminally through the vein and into the patient's coronary sinus; expanding the occluding member to thereby occlude the patient's coronary sinus; and delivering a cardioplegic fluid comprising blood and a cardioplegic agent through the retrograde delivery catheter to the coronary sinus at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm Hg.
Claim 3
Dependent Claim
18 words
The method of claim 1 wherein the cardioplegic fluid has a viscosity of at least about 3.0 centipoise.
Claim 4
Dependent Claim
35 words
The method of claim 1 wherein the cardioplegic fluid comprises a mixture of blood and a cardioplegic agent in a ratio of at least about two parts blood to one part cardioplegic agent by volume.
Claim 5
Dependent Claim
14 words
The method of claim 3 wherein the cardioplegic agent comprises an aqueous KCl solution.
Claim 6
Dependent Claim
24 words
The method of claim 1 wherein the cardioplegic fluid is cooled to a temperature of 3° C.-10° C. before delivery to the coronary sinus.
Claim 7
Dependent Claim
32 words
The method of claim 1 wherein the advancing step is carried out with the retrograde delivery catheter being introduced over a guidewire slidably positioned in a lumen in the retrograde delivery catheter.
Claim 8
Dependent Claim
34 words
The method of claim 1 wherein the retrograde delivery catheter has at least two bends in a distal portion thereof, the method further comprising straightening the at least two bends during the advancing step.
Claim 9
Dependent Claim
24 words
The method of claim 1 wherein the advancing step comprises using fluoroscopy to observe the position of the retrograde delivery catheter in the heart.
Claim 10
Dependent Claim
28 words
The method of claim 8 wherein the advancing step further comprises injecting a radiopaque contrast fluid through the retrograde delivery catheter to determine the position thereof using fluoroscopy.
Claim 11
Dependent Claim
95 words
The method of claim 1 further comprising the steps of: withdrawing blood from a peripheral vein; oxygenating the withdrawn blood from the peripheral vein; returning the oxygenated blood to a peripheral artery; and isolating the coronary arteries from the oxygenated blood returned to the peripheral artery; wherein the isolating step includes the steps of positioning an endoaortic catheter in a peripheral artery, advancing the endoaortic catheter into the aorta, and expanding an expanding member on the distal end of the endoaortic catheter to occlude an aortic lumen between the coronary arteries and the brachiocephalic artery.
Claim 12
Dependent Claim
29 words
The method of claim 10 wherein the step of venting comprises withdrawing fluid from the aortic lumen upstream of the expandable member through a lumen in the endoaortic catheter.
Claim 13
Dependent Claim
45 words
The method of claim 10 further comprising the step of venting the heart of fluid, wherein the venting step includes withdrawing fluid from a pulmonary artery through a venting catheter positioned in a peripheral vein and extending transluminally through the heart into the pulmonary artery.
Claim 14
Independent Claim
74 words
A method of delivering a fluid to a coronary sinus of a patient's heart, the method comprising: positioning a retrograde delivery catheter in a peripheral vein and advancing the retrograde delivery catheter transluminally into the coronary sinus; and delivering the fluid to the coronary sinus through a lumen in the retrograde delivery catheter, the lumen having a cross-sectional area of no less than 4 mm 2 at any location along the retrograde delivery catheter.
Claim 15
Independent Claim
74 words
A method of delivering a fluid to a coronary sinus of a patient's heart, the method comprising: positioning a retrograde delivery catheter in a peripheral vein and advancing the retrograde delivery catheter transluminally into the coronary sinus; and delivering the fluid to the coronary sinus through a lumen in the retrograde delivery catheter, the lumen having a cross-sectional area of no less than 4 mm 2 at any location along the retrograde delivery catheter.
Claim 16
Dependent Claim
16 words
The method of claim 13 wherein the fluid has a viscosity of at least 3.0 centipoise.
Claim 17
Dependent Claim
28 words
The method of claim 14 wherein the fluid is delivered at a flow rate of at least 200 ml/min. at a pump pressure of less than 300 mmHg.
Claim 18
Dependent Claim
27 words
The method of claim 13 wherein the fluid comprises a cardioplegic fluid, the method further comprising supporting the patient on cardiopulmonary bypass during the step of delivering.
Claim 19
Dependent Claim
25 words
The method of claim 13 wherein the step of positioning comprises using fluoroscopy to observe the position of the retrograde delivery catheter in the heart.
Claim 20
Dependent Claim
28 words
The method of claim 17 wherein the positioning step further comprises injecting a radiopaque contrast fluid through the retrograde delivery catheter to determine the position thereof using fluoroscopy.
Claim 21
Independent Claim
150 words
A method of inducing cardioplegic arrest of a patient's heart, the heart having an aorta leading away therefrom to a peripheral artery, coronary arteries in communication with the aorta, and a brachiocephalic artery in communication with the aorta downstream from the coronary arteries, the method comprising: providing a retrograde delivery catheter having an occluding member, the occluding member having a collapsed shape and an expanded shape, the retrograde delivery catheter having a lumen and an outlet positioned distal to the occluding member for delivering a fluid to the patient's coronary sinus; inserting the retrograde delivery catheter through a vein in the patient; advancing the retrograde delivery catheter transluminally through the vein and into the patient's coronary sinus; expanding the occluding member to occlude the patient's coronary sinus; and delivering a cardioplegic fluid comprising blood and a cardioplegic agent through the lumen of the retrograde delivery catheter to the coronary sinus.
Claim 22
Independent Claim
150 words
A method of inducing cardioplegic arrest of a patient's heart, the heart having an aorta leading away therefrom to a peripheral artery, coronary arteries in communication with the aorta, and a brachiocephalic artery in communication with the aorta downstream from the coronary arteries, the method comprising: providing a retrograde delivery catheter having an occluding member, the occluding member having a collapsed shape and an expanded shape, the retrograde delivery catheter having a lumen and an outlet positioned distal to the occluding member for delivering a fluid to the patient's coronary sinus; inserting the retrograde delivery catheter through a vein in the patient; advancing the retrograde delivery catheter transluminally through the vein and into the patient's coronary sinus; expanding the occluding member to occlude the patient's coronary sinus; and delivering a cardioplegic fluid comprising blood and a cardioplegic agent through the lumen of the retrograde delivery catheter to the coronary sinus.
Claim 23
Dependent Claim
47 words
The method of claim 19, wherein: the inserting step is carried out with the retrograde delivery catheter including a distal portion having an outer diameter of less than about 4.6 mm, the distal portion having a length of at least 50 cm proximal to the distal end.
Claim 24
Dependent Claim
49 words
The method of claim 19, wherein: the delivering step is carried out with the lumen being configured to deliver a fluid having a viscosity of at least about 3.0 centipoise at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm.
Claim 25
Dependent Claim
73 words
The method of claim 19, wherein: the inserting step is carried out with the retrograde delivery catheter including a shaft having at least a first bend near the distal end of the shaft to facilitate positioning the distal end in the coronary sinus, the first bend being in a range of about 20° to 70° from a longitudinal axis of a proximal portion of the retrograde delivery catheter proximal to the first bend.
Claim 26
Dependent Claim
59 words
The method of claim 19, wherein: the inserting step is carried out with the retrograde delivery catheter having a flexible, elongated shaft, the shaft having a first bend near the distal end of the shaft to facilitate positioning the distal end in the coronary sinus, the first bend being between 20 mm and 40 mm from the distal end.
Claim 27
Dependent Claim
67 words
The method of claim 19, wherein: the inserting step is carried out with the retrograde delivery catheter including a shaft having a first bend near the distal end of the shaft to facilitate positioning the distal end in the coronary sinus, the first bend being between 20 mm and 40 mm from the distal end, the shaft also having a second bend distal to the first bend.
Claim 28
Dependent Claim
117 words
The method of claim 19, wherein: the inserting step is carried out with the retrograde delivery catheter having configured to deliver a fluid having a viscosity of at least about 3.0 centipoise at a flow rate of at least 200 ml/min. and at a pump pressure of less than 300 mm, an inflation lumen extending through the shaft, the expandable member including an inflatable balloon having an interior in communication with the inflation lumen, the balloon being configured to be inflatable to a size larger than the coronary sinus, the retrograde delivery catheter further including pressure limiting means to maintain inflation pressure of the balloon below a predetermined value selected to avoid injury to coronary sinus tissue.
Claim 29
Independent Claim
210 words
A method of inducing cardioplegic arrest of a patient's heart, the heart having an aorta leading away therefrom to a peripheral artery, coronary arteries in communication with the aorta, and a brachiocephalic artery in communication with the aorta downstream from the coronary arteries, the method comprising: providing a retrograde delivery catheter having an occluding member, the occluding member having a collapsed shape and an expanded shape, the retrograde delivery catheter also having a lumen and an outlet positioned distal to the occluding member for delivering a fluid to a patient's coronary sinus; inserting the retrograde delivery catheter through a peripheral vein in the patient; advancing the retrograde delivery catheter transluminally through the vein and into the patient's coronary sinus; expanding the occluding member to thereby occlude the patient's coronary sinus; delivering a cardioplegic fluid comprising blood and a cardioplegic agent through the retrograde delivery catheter to the coronary sinus; positioning an aortic occlusion device in the patient's ascending aorta, the aortic occlusion device having an occluding member; expanding an expanding member on the distal end of the endoaortic catheter to occlude an aortic lumen between the coronary arteries and the brachiocephalic artery; and delivering the cardioplegic fluid to the patient's ascending aorta through a lumen in the aortic occlusion device.
Claim 30
Independent Claim
210 words
A method of inducing cardioplegic arrest of a patient's heart, the heart having an aorta leading away therefrom to a peripheral artery, coronary arteries in communication with the aorta, and a brachiocephalic artery in communication with the aorta downstream from the coronary arteries, the method comprising: providing a retrograde delivery catheter having an occluding member, the occluding member having a collapsed shape and an expanded shape, the retrograde delivery catheter also having a lumen and an outlet positioned distal to the occluding member for delivering a fluid to a patient's coronary sinus; inserting the retrograde delivery catheter through a peripheral vein in the patient; advancing the retrograde delivery catheter transluminally through the vein and into the patient's coronary sinus; expanding the occluding member to thereby occlude the patient's coronary sinus; delivering a cardioplegic fluid comprising blood and a cardioplegic agent through the retrograde delivery catheter to the coronary sinus; positioning an aortic occlusion device in the patient's ascending aorta, the aortic occlusion device having an occluding member; expanding an expanding member on the distal end of the endoaortic catheter to occlude an aortic lumen between the coronary arteries and the brachiocephalic artery; and delivering the cardioplegic fluid to the patient's ascending aorta through a lumen in the aortic occlusion device.
Claim 31
Dependent Claim
25 words
The method of claim 26 wherein the positioning step is carried out by passing the aortic occlusion device through a peripheral artery of the patient.
Claim 32
Dependent Claim
45 words
The method of claim 26 further comprising the step of venting the heart of fluid, wherein the venting step includes withdrawing fluid from a pulmonary artery through a venting catheter positioned in a peripheral vein and extending transluminally through the heart into the pulmonary artery.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2001-04-13 | 2001-10-13 | 2002-04-14 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2005-04-13 | 2005-10-13 | 2006-04-14 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2009-04-13 | 2009-10-13 | 2010-04-14 | $7700.00 | Window Closed / Lapsed |