Patent US5120299A successfully refreshed from Google Patents.
US5120299A
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US
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Intra-aortic balloon assembly with hemostasis device
Assignee: Kontron Instruments Inc
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Filing: 1990-11-07
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Granted: 1992-06-09
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Expires: 2010-11-07
Abstract
Abstract An intra-aortic balloon assembly which includes an hemostasis device slidably mounted to a balloon catheter, and method for percutaneous insertion of such assembly. The hemostasis device provides a distal constant diameter segment dimensioned to minimize initial resistance to the insertion of the hemostasis device, integrated with a second proximal segment of larger constant diameter via a transition segment. The second constant diameter segment is proportioned to fill the opening in the patient's skin created by the insertion of the intra-aortic balloon and thereby stop any bleeding from the femoral artery at the insertion site. The method includes the steps of (1) percutaneously inserting the intra-aortic balloon into the femoral common artery, with or without the use of a tear-away insertion sheath, (2) removing the insertion sheath (if one is used) after insertion of the intra-aortic balloon assembly, and (3) inserting the hemostasis device into the patient's skin at the insertion site to stop bleeding which may occur upon sheathless insertion of the wrapped balloon or removal of the insertion sheath.
Inventors
- 👤 Edward J. Lombardi
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-11-05 10:40
CPC Classifications
A; A61; A61M; A61M39/00; A61M39/02; A61M39/06; A61M39/0606; A61M25/00; A61M25/01; A61M25/06
Claims Analysis
Total Claims: 15
Claim 1
Independent Claim
341 words
An intra-aortic balloon apparatus comprising: a balloon catheter having a proximal end and a distal end; an inflatable and deflatable balloon bladder sealidly attached to the distal end of said balloon catheter for percutaneous insertion into the femoral artery of patient; a hemostasis device having a proximal end and a distal end, said hemostasis device slidably mounted to said balloon catheter between said balloon bladder and said proximal end of said balloon catheter, said hemostasis device including: i) a first segment formed at said distal end of said hemostasis device having a constant outside diameter, said first segment being of a dimension which is as small as possible so as to pass through the opening made by the passage of said balloon bladder through the percutaneous insertion site and into said femoral artery; ii) a second segment for insertion into said percutaneous insertion site opening positioned proximally with respect to said first segment, said second segment having a constant diameter larger than the outside diameter of said first segment and being of a dimension so as to fill said opening to stop any bleeding from said femoral artery at said insertion site, yet permit blood flow along said femoral artery; iii) a transition segment connecting said first segment to said second segment, said transition segment having a dimension so as to allow essentially immediate transition from said first segment to said second segment during insertion of said hemostasis device into said percutaneous insertion site opening, yet at the same time minimize any resistance encountered during the insertion of said second segment through the patient's skin; iv) said hemostasis device having an inside diameter dimension so as to provide a clearance between the inside of said hemostasis device at said distal end and said balloon catheter of between about 2 to 3 thousandths of an inch; and sealing means releasably attached to the proximal end of said hemostasis device for preventing bleeding between said hemostasis device and said balloon catheter after insertion of said balloon bladder and hemostasis device in the patient.
Claim 2
Dependent Claim
341 words
An intra-aortic balloon apparatus comprising: a balloon catheter having a proximal end and a distal end; an inflatable and deflatable balloon bladder sealidly attached to the distal end of said balloon catheter for percutaneous insertion into the femoral artery of patient; a hemostasis device having a proximal end and a distal end, said hemostasis device slidably mounted to said balloon catheter between said balloon bladder and said proximal end of said balloon catheter, said hemostasis device including: i) a first segment formed at said distal end of said hemostasis device having a constant outside diameter, said first segment being of a dimension which is as small as possible so as to pass through the opening made by the passage of said balloon bladder through the percutaneous insertion site and into said femoral artery; ii) a second segment for insertion into said percutaneous insertion site opening positioned proximally with respect to said first segment, said second segment having a constant diameter larger than the outside diameter of said first segment and being of a dimension so as to fill said opening to stop any bleeding from said femoral artery at said insertion site, yet permit blood flow along said femoral artery; iii) a transition segment connecting said first segment to said second segment, said transition segment having a dimension so as to allow essentially immediate transition from said first segment to said second segment during insertion of said hemostasis device into said percutaneous insertion site opening, yet at the same time minimize any resistance encountered during the insertion of said second segment through the patient's skin; iv) said hemostasis device having an inside diameter dimension so as to provide a clearance between the inside of said hemostasis device at said distal end and said balloon catheter of between about 2 to 3 thousandths of an inch; and sealing means releasably attached to the proximal end of said hemostasis device for preventing bleeding between said hemostasis device and said balloon catheter after insertion of said balloon bladder and hemostasis device in the patient.
Claim 3
Dependent Claim
20 words
An intra-aortic balloon apparatus according to claim 1, wherein said first segment is about one-eighth of an inch in length.
Claim 4
Dependent Claim
20 words
An intra-aortic balloon apparatus according to claim 1, wherein said transition segment is about one-eighth of an inch in length.
Claim 5
Dependent Claim
18 words
An intra-aortic balloon apparatus according to claim 1, wherein said second segment is about three inches in length.
Claim 6
Dependent Claim
20 words
An intra-aortic balloon apparatus according to claim 1, wherein the overall length of said hemostasis device is about four inches.
Claim 7
Dependent Claim
362 words
An intra-aortic balloon apparatus comprising: a balloon catheter having a proximal end and a distal end; an inflatable and deflatable balloon bladder sealidly attached to the distal end of said balloon catheter for percutaneous insertion into the femoral artery of patient; a hemostasis device having a proximal end and a distal end, said hemostasis device slidably mounted to said balloon catheter between said balloon bladder and said proximal end of said balloon catheter, said hemostasis device including: i) a first segment formed at said distal end of said hemostasis device having a length of about one-eighth of an inch and a constant outside diameter, said first segment being of a dimension which is as small as possible so as to pass through the opening made by the passage of said balloon bladder through the percutaneous insertion site and into said femoral artery; ii) a second segment for insertion into said percutaneous insertion site opening positioned proxially with respect to said first segment, said second segment having a constant outside diameter larger than the outside diameter of said first segment and being of a dimension so as to fill said opening to stop any bleeding from said femoral artery at said insertion site, yet permit blood flow along said femoral artery; iii) a transition segment connecting said first segment to said second segment having a length of about one-eighth of an inch, said transition segment having a dimension so as to allow essentially immediate transition from said first segment to said second segment during insertion of said hemostasis device into said percutaneous insertion site opening, yet at the same time minimize any resistance encountered during the insertion of said second segment through the patient's skin; iv) said hemostasis device having an inside diameter dimension so as to provide a clearance between the inside of said hemostasis device at its distal end and said balloon catheter of no more than about 2 to 3 thousandths of an inch; and sealing means releasably attached to the proximal end of said hemostasis device for preventing bleeding between said hemostasis device and said balloon catheter after insertion of said balloon bladder and hemostasis device in the patient.
Claim 8
Dependent Claim
362 words
An intra-aortic balloon apparatus comprising: a balloon catheter having a proximal end and a distal end; an inflatable and deflatable balloon bladder sealidly attached to the distal end of said balloon catheter for percutaneous insertion into the femoral artery of patient; a hemostasis device having a proximal end and a distal end, said hemostasis device slidably mounted to said balloon catheter between said balloon bladder and said proximal end of said balloon catheter, said hemostasis device including: i) a first segment formed at said distal end of said hemostasis device having a length of about one-eighth of an inch and a constant outside diameter, said first segment being of a dimension which is as small as possible so as to pass through the opening made by the passage of said balloon bladder through the percutaneous insertion site and into said femoral artery; ii) a second segment for insertion into said percutaneous insertion site opening positioned proxially with respect to said first segment, said second segment having a constant outside diameter larger than the outside diameter of said first segment and being of a dimension so as to fill said opening to stop any bleeding from said femoral artery at said insertion site, yet permit blood flow along said femoral artery; iii) a transition segment connecting said first segment to said second segment having a length of about one-eighth of an inch, said transition segment having a dimension so as to allow essentially immediate transition from said first segment to said second segment during insertion of said hemostasis device into said percutaneous insertion site opening, yet at the same time minimize any resistance encountered during the insertion of said second segment through the patient's skin; iv) said hemostasis device having an inside diameter dimension so as to provide a clearance between the inside of said hemostasis device at its distal end and said balloon catheter of no more than about 2 to 3 thousandths of an inch; and sealing means releasably attached to the proximal end of said hemostasis device for preventing bleeding between said hemostasis device and said balloon catheter after insertion of said balloon bladder and hemostasis device in the patient.
Claim 9
Dependent Claim
18 words
An intra-aortic balloon apparatus according to claim 6, wherein said transition segment is about one-eighth inch in length.
Claim 10
Dependent Claim
18 words
An intra-aortic balloon apparatus according to claim 7, wherein said second segment is about three inches in length.
Claim 11
Dependent Claim
20 words
An intra-aortic balloon apparatus according to claim 8, wherein the overall length of said hemostasis device is about four inches.
Claim 12
Independent Claim
238 words
A method for percutaneous insertion of an intra-aortic balloon apparatus into a patient's body though a tear-away insertion sheath and into the femoral artery, wherein said intra-aortic balloon apparatus includes a balloon catheter having a proximal end and a distal end, an inflatable and deflatable balloon bladder sealidly attached to the distal end of the balloon catheter, and a hemostasis device slidably mounted to said balloon catheter, said hemostasis device having a first constant outside diameter segment formed at the distal end thereof configured and having a dimension so as to generate less initial resistance during insertion into the patient's skin, said hemostasis device further including a second constant outside diameter segment having a dimension so as to fill the opening in the patient's skin created by insertion of said balloon bladder thereinto to stop bleeding from said femoral artery at the insertion site, said method comprising the steps of: percutaneously inserting the balloon catheter into the patient's femoral artery through the tear-away insertion sheath; removing the tear-away insertion sheath from the body after insertion of said intra-aortic balloon apparatus; and sliding said hemostasis device along said balloon catheter into the opening in the patient's skin at the insertion site, and thence into the femoral artery until said second of said hemostasis device fills said opening so as to stop bleeding from the puncture in the femoral artery which may result when said tear-away insertion sheath is removed.
Claim 13
Independent Claim
238 words
A method for percutaneous insertion of an intra-aortic balloon apparatus into a patient's body though a tear-away insertion sheath and into the femoral artery, wherein said intra-aortic balloon apparatus includes a balloon catheter having a proximal end and a distal end, an inflatable and deflatable balloon bladder sealidly attached to the distal end of the balloon catheter, and a hemostasis device slidably mounted to said balloon catheter, said hemostasis device having a first constant outside diameter segment formed at the distal end thereof configured and having a dimension so as to generate less initial resistance during insertion into the patient's skin, said hemostasis device further including a second constant outside diameter segment having a dimension so as to fill the opening in the patient's skin created by insertion of said balloon bladder thereinto to stop bleeding from said femoral artery at the insertion site, said method comprising the steps of: percutaneously inserting the balloon catheter into the patient's femoral artery through the tear-away insertion sheath; removing the tear-away insertion sheath from the body after insertion of said intra-aortic balloon apparatus; and sliding said hemostasis device along said balloon catheter into the opening in the patient's skin at the insertion site, and thence into the femoral artery until said second of said hemostasis device fills said opening so as to stop bleeding from the puncture in the femoral artery which may result when said tear-away insertion sheath is removed.
Claim 14
Independent Claim
238 words
A method for sheathless percutaneous insertion of an intra-aortic balloon apparatus into a patient's body and into the femoral artery, wherein said intra-aortic balloon apparatus includes a balloon catheter having a proximal end and distal end, an inflatable and deflatable balloon bladder sealidly attached to the distal end of the balloon catheter, and a hemostasis device slidably mounted to said balloon catheter, said hemostasis device having a first constant outside diameter segment formed at the distal end thereof configured and having a dimension so as to generate less initial resistance during insertion into the patient's skin, said hemostasis device further including a second constant outside diameter segment with a dimension so as to fill the opening in the patient's skin created by insertion of said balloon bladder thereinto to stop bleeding from said femoral artery at the insertion site, said method comprising the steps of: forming an opening in the patient's skin and into the femoral artery and progressively dilating said opening to increase its size; inserting said intra-aortic balloon apparatus through said opening and up through the femoral artery to the vicinity of the aortic arch; and sliding said hemostasis device along said balloon catheter into said opening, and thence into the femoral artery until said second segment of said hemostasis device fills said opening so as to stop bleeding from the puncture in the femoral artery which may result when said intra-aortic balloon is inserted thereto.
Claim 15
Independent Claim
238 words
A method for sheathless percutaneous insertion of an intra-aortic balloon apparatus into a patient's body and into the femoral artery, wherein said intra-aortic balloon apparatus includes a balloon catheter having a proximal end and distal end, an inflatable and deflatable balloon bladder sealidly attached to the distal end of the balloon catheter, and a hemostasis device slidably mounted to said balloon catheter, said hemostasis device having a first constant outside diameter segment formed at the distal end thereof configured and having a dimension so as to generate less initial resistance during insertion into the patient's skin, said hemostasis device further including a second constant outside diameter segment with a dimension so as to fill the opening in the patient's skin created by insertion of said balloon bladder thereinto to stop bleeding from said femoral artery at the insertion site, said method comprising the steps of: forming an opening in the patient's skin and into the femoral artery and progressively dilating said opening to increase its size; inserting said intra-aortic balloon apparatus through said opening and up through the femoral artery to the vicinity of the aortic arch; and sliding said hemostasis device along said balloon catheter into said opening, and thence into the femoral artery until said second segment of said hemostasis device fills said opening so as to stop bleeding from the puncture in the femoral artery which may result when said intra-aortic balloon is inserted thereto.
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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) | 1995-06-09 | 1995-12-09 | 1996-06-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1999-06-09 | 1999-12-09 | 2000-06-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2003-06-09 | 2003-12-09 | 2004-06-09 | $7700.00 | Window Closed / Lapsed |