Patent US5695457A successfully refreshed from Google Patents.
US5695457A
Expired / Lapsed
US
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Cardioplegia catheter system
Assignee: Edwards Lifesciences LLC
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Filing: 1994-12-07
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Granted: 1997-12-09
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Expires: 2014-12-07
Abstract
Abstract A catheter system is provided for accessing the coronary ostia transluminally from a peripheral arterial access site, such as the femoral artery, and for inducing cardioplegic arrest by direct infusion of cardioplegic solution into the coronary arteries. In a first embodiment, the catheter system is in the form of a single perfusion catheter with multiple distal branches for engaging the coronary ostia. In a second embodiment, multiple perfusion catheters are delivered to the coronary ostia through a single arterial cannula. In a third embodiment, multiple perfusion catheters are delivered to the coronary ostia through a single guiding catheter. In a fourth embodiment, multiple catheters are delivered to the coronary ostia through a single guiding catheter which has distal exit ports that are arranged to direct the perfusion catheters into the coronary ostia. In each embodiment, the catheters are equipped with an occlusion means at the distal end of the catheter for closing the coronary ostia and isolating the coronary arteries from the systemic blood flow. The occlusion means can take the form of an inflatable occlusion balloon cuff, a tapered occlusion device or an O-ring encircling the distal end of the catheter. An optional ventricular venting catheter can be included in the system for venting blood and fluids from the left ventricle of the heart. The catheter system is combined with a femoral-to-femoral cardiopulmonary bypass system to provide a system for cardioplegic arrest and total cardiopulmonary support during minimally invasive cardiac surgical procedures.
Inventors
- 👤 Frederick G. St. Goar
- 👤 William S. Peters
- 👤 Philip C. Evard
- 👤 Stephen W. Boyd
- 👤 Craig L. Adams
- 👤 Richard L. Mueller, Jr.
- 👤 John H. Stevens
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 10:39
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/0067; A61M25/0068; A61F; A61F2/00; A61F2/02; A61F2/24; A61F2/2427; A61M1/00; A61M1/36; A61M1/3613; A61M1/3621; A61M1/3653; A61M1/3659; A61M25/0021; A61M25/0041; A61M25/01; A61M25/06; A61M25/0662; A61M25/10; A61B; A61B17/00; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B18/00; A61B2018/00053; A61B2018/00214; A61B2018/0022; A61B2018/00232; A61B2018/0025; A61B2018/00261; A61M25/0023; A61M25/0026; A61M25/003; A61M2025/0031; A61M2025/0034; A61M2025/0036; A61M2025/004; A61M25/0043; A61M2025/0057; A61M25/0074; A61M25/0075; A61M2025/0076; A61M2025/0078; A61M25/0082; A61M25/0084; A61M2025/0087; A61M25/02; A61M2025/028; A61M2025/1043; A61M2025/1047; A61M2025/1077; A61M2202/00; A61M2202/04; A61M2202/0468; A61M2202/047; A61M2205/00; A61M2205/11; A61M2205/36; A61M2205/366; A61M2210/00; A61M2210/12; A61M2210/125; A61M25/005; A61M25/008; A61M25/0105; A61M25/0125; A61M25/1002
Claims Analysis
Total Claims: 26
Claim 1
Independent Claim
200 words
A perfusion catheter for inducing cardioplegic arrest in a patient's heart, said perfusion catheter comprising: a shaft having a proximal end and a distal end, said distal end being sized for entering a patient's first coronary ostium, said catheter shaft having a length sufficient to allow said distal end to enter the first coronary ostium when said proximal end extends out of a peripheral artery of the patient; a first occlusion member mounted to the shaft, the first occlusion member being sized to occlude the first coronary ostium; a first lumen extending through the shaft, the first lumen having an inlet at said proximal end and a perfusion port positioned distal to said first occlusion member for infusing cardioplegic fluid into the patient's coronary ostium, and an arterial cannula having a distal end which is adapted for introduction into the peripheral artery of said patient and an infusion lumen communicating with an opening in said arterial cannula for infusing blood into said peripheral artery of said patient, said arterial cannula having a fitting configured to connect said infusion lumen to a cardiopulmonary bypass system for returning oxygenated blood to the patient; the shaft being slidably coupled to the arterial cannula.
Claim 2
Dependent Claim
200 words
A perfusion catheter for inducing cardioplegic arrest in a patient's heart, said perfusion catheter comprising: a shaft having a proximal end and a distal end, said distal end being sized for entering a patient's first coronary ostium, said catheter shaft having a length sufficient to allow said distal end to enter the first coronary ostium when said proximal end extends out of a peripheral artery of the patient; a first occlusion member mounted to the shaft, the first occlusion member being sized to occlude the first coronary ostium; a first lumen extending through the shaft, the first lumen having an inlet at said proximal end and a perfusion port positioned distal to said first occlusion member for infusing cardioplegic fluid into the patient's coronary ostium, and an arterial cannula having a distal end which is adapted for introduction into the peripheral artery of said patient and an infusion lumen communicating with an opening in said arterial cannula for infusing blood into said peripheral artery of said patient, said arterial cannula having a fitting configured to connect said infusion lumen to a cardiopulmonary bypass system for returning oxygenated blood to the patient; the shaft being slidably coupled to the arterial cannula.
Claim 3
Dependent Claim
36 words
The catheter of claim 1, wherein: said first occlusion member includes a first elastomeric balloon having an interior; and the shaft includes a first inflation lumen which communicates with the interior of said first elastomeric balloon.
Claim 4
Dependent Claim
16 words
The catheter of claim 1, wherein: said first occlusion member has a first conically tapered surface.
Claim 5
Dependent Claim
19 words
The catheter of claim 1, wherein: said first occlusion member includes a first toroidal O-ring encircling said first shaft.
Claim 6
Dependent Claim
18 words
The catheter of claim 1, further comprising: means for measuring a pressure distal to said first occlusion member.
Claim 7
Dependent Claim
29 words
The catheter of claim 1, wherein: said catheter shaft includes a pressure monitoring lumen which communicates with a port, said port being positioned distal to said first occlusion member.
Claim 8
Dependent Claim
29 words
The catheter of claim 1, wherein: said catheter shaft has a distal portion which is shaped in a configuration adapted to direct said distal end into a coronary ostium.
Claim 9
Dependent Claim
39 words
The catheter of claim 1, wherein: the first lumen is sized to provide a flow rate of a fluid containing blood and a cardioplegic agent of at least approximately 100 ml/min at a pump pressure not exceeding 350 mmHg.
Claim 10
Dependent Claim
50 words
The catheter of claim 1, wherein: said elongated catheter shaft includes a vent branch having a venting lumen which communicates with a venting port, the venting branch having a length sufficient to extend into the patient's left ventricle when the first occlusion member is positioned in the first coronary ostium.
Claim 11
Dependent Claim
18 words
The catheter of claim 9, wherein: the vent branch is slidable relative to a remainder of the shaft.
Claim 12
Dependent Claim
151 words
The catheter of claim 1, wherein: the shaft has a proximal portion, a first branch and a second branch; the first branch having a length, the first occlusion member being mounted to the first branch and the first lumen extending through the first branch; the second branch having a length, a second end and a second occlusion member, the second occlusion member being sized and configured to occlude a second coronary ostium of the patient, said second branch also having a second lumen which communicates with a second perfusion port positioned distal to said second occlusion member for infusing cardioplegic fluid distal to the second occluding member; the proximal portion of the shaft and the length of the first and second branches being sized so that the first and second occlusion members are positioned in the first and second coronary ostia, respectively, when the proximal portion extends through the peripheral artery.
Claim 13
Dependent Claim
31 words
The catheter of claim 11, wherein: said first branch is shaped to direct said first end into the patient's first coronary ostium when the proximal portion extends through the peripheral artery.
Claim 14
Dependent Claim
80 words
The catheter of claim 11, further comprising: a first guide wire insertable into said first lumen of said first branch, said first guide wire having sufficient rigidity to straighten said first branch when said first guide wire is inserted into said first lumen; and a second guide wire insertable into said second lumen of said second branch, said second guide wire having sufficient rigidity to straighten said second branch when said second guide wire is inserted into said second lumen.
Claim 15
Dependent Claim
20 words
The catheter of claim 11, further comprising: means for delivering cardioplegic fluid through said first lumen and said second lumen.
Claim 16
Dependent Claim
16 words
The catheter of claim 11, wherein: the first branch is slidable relative to the second branch.
Claim 17
Dependent Claim
303 words
A cardioplegia catheter system for occluding a patient's left and right coronary ostia, comprising: a first catheter having a shaft, a first occluding member and a first lumen, the shaft having a proximal portion, a distal portion, a proximal end and a distal end, said distal portion being shaped to enter a patient's right coronary ostium when the proximal portion extends through a peripheral artery, said shaft having a length sufficient to allow said distal end to enter the right coronary ostium when the proximal portion extends through a peripheral artery, the first occlusion member being mounted to the shaft and being sized to occlude the right coronary ostium, the first lumen extending through the shaft and having an inlet at said proximal end and a perfusion port positioned distal to the first occlusion member; a second catheter having a shaft, a second occluding member and a second lumen, the shaft having a proximal portion, a distal portion, a proximal end and a distal end, said distal portion being shaped to enter the patient's left coronary ostium when the proximal portion extends through the peripheral artery, said shaft having a length sufficient to allow said distal end to enter the left coronary ostium when the proximal portion extends through the peripheral artery, the second occlusion member being mounted to the shaft and being sized to occlude the left coronary ostium, the second lumen extending through the shaft and having an inlet at said proximal end and a perfusion port positioned distal to the second occlusion member; and an arterial cannula having a blood flow lumen configured to be coupled to an arterial return line of a cardiopulmonary bypass system for returning oxygenated blood to the patient; first and second catheters extending through the arterial cannula and being slidably coupled to the arterial cannula.
Claim 18
Dependent Claim
303 words
A cardioplegia catheter system for occluding a patient's left and right coronary ostia, comprising: a first catheter having a shaft, a first occluding member and a first lumen, the shaft having a proximal portion, a distal portion, a proximal end and a distal end, said distal portion being shaped to enter a patient's right coronary ostium when the proximal portion extends through a peripheral artery, said shaft having a length sufficient to allow said distal end to enter the right coronary ostium when the proximal portion extends through a peripheral artery, the first occlusion member being mounted to the shaft and being sized to occlude the right coronary ostium, the first lumen extending through the shaft and having an inlet at said proximal end and a perfusion port positioned distal to the first occlusion member; a second catheter having a shaft, a second occluding member and a second lumen, the shaft having a proximal portion, a distal portion, a proximal end and a distal end, said distal portion being shaped to enter the patient's left coronary ostium when the proximal portion extends through the peripheral artery, said shaft having a length sufficient to allow said distal end to enter the left coronary ostium when the proximal portion extends through the peripheral artery, the second occlusion member being mounted to the shaft and being sized to occlude the left coronary ostium, the second lumen extending through the shaft and having an inlet at said proximal end and a perfusion port positioned distal to the second occlusion member; and an arterial cannula having a blood flow lumen configured to be coupled to an arterial return line of a cardiopulmonary bypass system for returning oxygenated blood to the patient; first and second catheters extending through the arterial cannula and being slidably coupled to the arterial cannula.
Claim 19
Dependent Claim
23 words
The system of claim 16, wherein: the first and second catheters each include means for sensing a pressure distal to the occluding member.
Claim 20
Dependent Claim
28 words
The system of claim 16, wherein: the first and second catheters each include a second lumen having an outlet distal to the first and second occluding members, respectively.
Claim 21
Dependent Claim
188 words
A cardioplegia catheter for occluding a patient's left and right coronary ostia and delivering cardioplegic fluid to the left and right coronary arteries, comprising: a first branch including a cardioplege lumen, a first occluding member, and a shaft having a distal end and a proximal end, the first occluding member being configured to occlude the right coronary ostium, the first branch having a length sufficient to extend through a peripheral artery when the first occluding member is positioned in the right coronary ostium, the cardioplege lumen extending from the proximal end to an outlet positioned distal to the first occluding member; a second branch having a second occluding member and a second cardioplege lumen, the second branch being coupled to the first branch, the second branch having a second occluding member configured to occlude the left coronary ostium, the cardioplege lumen having an outlet positioned distal to the second occluding member; and an arterial return cannula having a blood flow lumen configured to be coupled to a cardipulmonary bypass system for returning oxygenated blood to the patient; a first branch being slidably coupled to the arterial return cannula.
Claim 22
Dependent Claim
188 words
A cardioplegia catheter for occluding a patient's left and right coronary ostia and delivering cardioplegic fluid to the left and right coronary arteries, comprising: a first branch including a cardioplege lumen, a first occluding member, and a shaft having a distal end and a proximal end, the first occluding member being configured to occlude the right coronary ostium, the first branch having a length sufficient to extend through a peripheral artery when the first occluding member is positioned in the right coronary ostium, the cardioplege lumen extending from the proximal end to an outlet positioned distal to the first occluding member; a second branch having a second occluding member and a second cardioplege lumen, the second branch being coupled to the first branch, the second branch having a second occluding member configured to occlude the left coronary ostium, the cardioplege lumen having an outlet positioned distal to the second occluding member; and an arterial return cannula having a blood flow lumen configured to be coupled to a cardipulmonary bypass system for returning oxygenated blood to the patient; a first branch being slidably coupled to the arterial return cannula.
Claim 23
Dependent Claim
63 words
The catheter of claim 19, wherein: the first branch has a distal portion shaped to position the first occluding member in the right coronary ostium when the first branch extends through the peripheral artery; and the second branch has a distal portion shaped to position the first occluding member in the left coronary ostium when the first branch extends through the peripheral artery.
Claim 24
Dependent Claim
16 words
The catheter of claim 19, wherein: the first branch is slidably coupled to the second branch.
Claim 25
Dependent Claim
24 words
The catheter of claim 19, further comprising: means for sensing a pressure distal to at least one of the first and second occluding members.
Claim 26
Dependent Claim
22 words
The catheter of claim 19, wherein: the first branch includes a second lumen having an outlet distal to the first occluding member.
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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) | 2000-12-08 | 2001-06-09 | 2001-12-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2004-12-08 | 2005-06-09 | 2005-12-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2008-12-08 | 2009-06-09 | 2009-12-09 | $7700.00 | Window Closed / Lapsed |