US4576142A
Expired / Lapsed
US
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Percutaneous intra-aortic balloon and method for using same
Assignee: Arrow Interventional Inc
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Filing: 1982-11-19
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Granted: 1986-03-18
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Expires: 2002-11-19
Abstract
Abstract An intra-aortic balloon assembly has a balloon whose distal end terminates in a tip and whose proximal end is joined and communicates with the interior of a catheter tube. A slender stylet extends rearwardly from the tip through the balloon and catheter tube. The balloon is arranged so that its longitudinal axis is significantly displaced from the stylet facilitating tight wrapping of the balloon about the stylet in a single spiral. The stylet may be affixed to the balloon and/or the catheter tube. Coupling means for rotating the stylet are provided for removing any undesired twisting experienced by the stylet during wrapping. The balloon is preferably pre-wrapped and is shipped to the user in the pre-wrapped condition. The balloon is retained in the wrapped condition by a removable holder having releasably joined holder halves encircling the wrapped balloon. Heat shrunk plastic sleeves retain the holder halves in the assembled state. The balloon is pushed out from the holder preparatory to its use, after which the sleeves may be cut away and the holder halves removed. The wrap may further be retained by immersing the balloon in a solution containing a sticky substance which holds the engaging surfaces of the wrapped balloon together. When the wrapped balloon is placed in the bloodstream, the sticky substance dissolves enabling the balloon to easily unwrap.
Inventors
- 👤 Peter Schiff
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 12:02
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1027; A61M25/1038; A61M25/1034; A61M25/104; A61M60/00; A61M60/10; A61M60/122; A61M60/126; A61M60/13; A61M60/135; A61M60/139; A61M60/20; A61M60/295; A61M60/40; A61M60/497; A61M60/80; A61M60/841; A61M60/843
Claims Analysis
Total Claims: 39
Claim 1
Independent Claim
143 words
A balloon assembly adapted for facilitating insertion in a vessel comprising: an elongated catheter tube; an elongated balloon having a proximal end joined to one end of said catheter tube and having an opposite, distal end terminating in a tip; a stylet having a distal end terminating in said tip and extending through said balloon and into said catheter tube; said balloon comprising a sleeve having a tapered distal and proximal end respectively joined to said tip and said catheter tube; said balloon assuming an annular cross-section when uninflated and being generally symmetric about an imaginary longitudinal axis; and said tapered distal and proximal ends joining said balloon to said tip and said catheter tube and aligning said stylet so that said stylet is substantially displaced from the longitudinal axis of said balloon to facilitate tight wrapping of the balloon about said stylet.
Claim 2
Dependent Claim
143 words
A balloon assembly adapted for facilitating insertion in a vessel comprising: an elongated catheter tube; an elongated balloon having a proximal end joined to one end of said catheter tube and having an opposite, distal end terminating in a tip; a stylet having a distal end terminating in said tip and extending through said balloon and into said catheter tube; said balloon comprising a sleeve having a tapered distal and proximal end respectively joined to said tip and said catheter tube; said balloon assuming an annular cross-section when uninflated and being generally symmetric about an imaginary longitudinal axis; and said tapered distal and proximal ends joining said balloon to said tip and said catheter tube and aligning said stylet so that said stylet is substantially displaced from the longitudinal axis of said balloon to facilitate tight wrapping of the balloon about said stylet.
Claim 3
Dependent Claim
25 words
The balloon assembly of claim 1 wherein the apex of each of said tapered balloon ends are both offset from said balloon longitudinal imaginary axis.
Claim 4
Dependent Claim
26 words
The balloon assembly of claim 1 wherein said tapered balloon ends have one tapered portion and one straight portion substantially forming a right angle imaginary cone.
Claim 5
Dependent Claim
63 words
The balloon assembly of claim 1 wherein the balloon has an oval cross-section defined by a pair of flat surface portions joined to a pair of curved portions, the ends of said balloon being adjacent one of said curved portions and being joined to said tip and catheter tube so that the stylet engages the interior surface of one of said curved portions.
Claim 6
Dependent Claim
45 words
The balloon assembly of claim 1 wherein the tapered ends of the balloon terminate in openings communicating with said tip and said catheter tube to place the stylet extending therethrough in close proximity with the interior surface along substantially the entire length of the balloon.
Claim 7
Dependent Claim
19 words
The balloon assembly of claim 4 wherein the remaining one of said curved portions is remote from said stylet.
Claim 8
Dependent Claim
14 words
The balloon assembly of claim 1 wherein said stylet is secured to said tip.
Claim 9
Dependent Claim
59 words
The balloon assembly of claim 7 further comprising coupling means joined to the proximal end of said catheter tube; said stylet extending through said catheter tube and into said coupling means; said coupling means including twisting means having a rotatable control knob; and the proximal end of said stylet being coupled to said twisting means for rotating said stylet.
Claim 10
Independent Claim
152 words
A method for preparing an intra-aortic balloon assembly for insertion into the body, said balloon assembly comprising a catheter tube and a balloon having a proximal end joined to the distal end of the catheter tube and having a distal end terminating in a tip; a stylet extending through said balloon and having a distal end terminating in said tip and a proximal end extending into the catheter tube; the balloon openings communicating with said tip and said catheter tube to hold the stylet is displaced from the longitudinal axis of the balloon, said method comprising the steps of: evacuating the balloon assembly sufficient to collapse the balloon so that the balloon assumes a flat tape-like cross-section, defined by a pair of flat portions joined at their ends along folds, said stylet lying against the interior of one of said folds; and wrapping the balloon in a tight spiral about the stylet.
Claim 11
Independent Claim
152 words
A method for preparing an intra-aortic balloon assembly for insertion into the body, said balloon assembly comprising a catheter tube and a balloon having a proximal end joined to the distal end of the catheter tube and having a distal end terminating in a tip; a stylet extending through said balloon and having a distal end terminating in said tip and a proximal end extending into the catheter tube; the balloon openings communicating with said tip and said catheter tube to hold the stylet is displaced from the longitudinal axis of the balloon, said method comprising the steps of: evacuating the balloon assembly sufficient to collapse the balloon so that the balloon assumes a flat tape-like cross-section, defined by a pair of flat portions joined at their ends along folds, said stylet lying against the interior of one of said folds; and wrapping the balloon in a tight spiral about the stylet.
Claim 12
Dependent Claim
53 words
The method of claim 9 wherein the wrapping step further comprises the steps of wrapping the balloon several times about the stylet; releasing and reapplying the vacuum condition and thereafter wrapping the balloon several more turns about the stylet; and repeating the last-mentioned step until the balloon is completely wrapped about the stylet.
Claim 13
Dependent Claim
17 words
The method of claim 10 further comprising the step of encasing the wrapped balloon in a holder.
Claim 14
Dependent Claim
26 words
The method of claim 11 further comprising the step of pushing the balloon out of the holder preparatory to insertion of the balloon into the body.
Claim 15
Dependent Claim
26 words
The method of claim 12 further comprising the step of inserting the distal end of the balloon into a sheath as it emerges from said holder.
Claim 16
Dependent Claim
26 words
The method of claim 13 further comprising the step of removing the holder from the balloon assembly after the balloon has completely emerged from the holder.
Claim 17
Dependent Claim
39 words
The method of claim 9 further comprising the step of introducing a lubricant into the interior of the balloon to facilitate sliding engagement between interior surfaces of the balloon as it is being wrapped to facilitate a tight wrap.
Claim 18
Dependent Claim
10 words
The method of claim 15 wherein the lubricant is water.
Claim 19
Dependent Claim
12 words
The method of claim 15 wherein the lubricant is a powdered lubricant.
Claim 20
Dependent Claim
44 words
The method of claim 9 further comprising the step of dipping the balloon into a solution containing a material which when dry, causes the adjacent external surfaces of the balloon to adhere to one another, said material being dissolved when placed in the bloodstream.
Claim 21
Dependent Claim
111 words
An intra-aortic balloon assembly comprising: an elongated balloon having an annular cross-section generally concentric about a longitudinal axis; said balloon having distal and proximal ends terminating in openings which are offset from said longitudinal axis; a catheter tube; the proximal end of said balloon being joined to the distal end of said catheter tube; the distal end of said balloon terminating in a tip; a stylet having a distal end positioned in said tip and extending through said balloon distal and proximal ends and into said catheter tube; said stylet extending generally along the centers of said distal and proximal ends and being offset from the longitudinal axis of said balloon.
Claim 22
Dependent Claim
111 words
An intra-aortic balloon assembly comprising: an elongated balloon having an annular cross-section generally concentric about a longitudinal axis; said balloon having distal and proximal ends terminating in openings which are offset from said longitudinal axis; a catheter tube; the proximal end of said balloon being joined to the distal end of said catheter tube; the distal end of said balloon terminating in a tip; a stylet having a distal end positioned in said tip and extending through said balloon distal and proximal ends and into said catheter tube; said stylet extending generally along the centers of said distal and proximal ends and being offset from the longitudinal axis of said balloon.
Claim 23
Dependent Claim
114 words
An intra-aortic balloon assembly comprising a catheter tube; an elongated balloon having an annular cross-section; the ends of said balloon terminating in openings; the intermediate portion of said balloon being substantially uniform in diameter, said openings having diameters substantially smaller than the diameter of said balloon intermediate portion; said openings being offset from said longitudinal axis; the proximal end of said balloon being joined to the distal end of said catheter tube; the distal opening of said balloon terminating in a tip; a stylet extending through said catheter tube, said proximal opening, said balloon, said distal opening and terminating in said tip; and said balloon openings positioning said stylet offset from said longitudinal axis.
Claim 24
Dependent Claim
114 words
An intra-aortic balloon assembly comprising a catheter tube; an elongated balloon having an annular cross-section; the ends of said balloon terminating in openings; the intermediate portion of said balloon being substantially uniform in diameter, said openings having diameters substantially smaller than the diameter of said balloon intermediate portion; said openings being offset from said longitudinal axis; the proximal end of said balloon being joined to the distal end of said catheter tube; the distal opening of said balloon terminating in a tip; a stylet extending through said catheter tube, said proximal opening, said balloon, said distal opening and terminating in said tip; and said balloon openings positioning said stylet offset from said longitudinal axis.
Claim 25
Dependent Claim
19 words
The intra-aortic balloon assembly of claim 20, wherein said stylet is affixed to the interior surface of said balloon.
Claim 26
Dependent Claim
19 words
The intra-aortic balloon assembly of claim 20 wherein said stylet is embedded in the wall of said catheter tube.
Claim 27
Dependent Claim
30 words
The intra-aortic balloon assembly of claim 20 wherein said catheter tube is comprised of inner and outer concentric tubes; and said stylet positioned between the engaging surfaces of said tubes.
Claim 28
Dependent Claim
18 words
The intra-aortic balloon assembly of claim 20 wherein a lubricant is provided in the interior of said balloon.
Claim 29
Dependent Claim
12 words
The intra-aortic balloon assembly of claim 24, wherein said lubricant is water.
Claim 30
Dependent Claim
14 words
The intra-aortic balloon assembly of claim 24, wherein said lubricant is a silicone powder.
Claim 31
Dependent Claim
58 words
The balloon assembly of claim 20 further comprising coupling means joined to the proximal end of said catheter tube; said stylet extending through said catheter tube and into said coupling means; said coupling means including twisting means having a rotatable control knob; the proximal end of said stylet being coupled to said twisting means for rotating said stylet.
Claim 32
Dependent Claim
133 words
An intra-aortic balloon assembly comprising a balloon having a distal end and a proximal end; a catheter tube having a distal end joined to the proximal end of said balloon; the distal end of the balloon terminating in a tip; a stylet extending between said tip and the proximal end of said catheter tube; the ends of the balloon being offset from the intermediate portion of said balloon to displace the stylet from the longitudinal axis of the balloon so that when the balloon is collapsed to a flat configuration defined by first and second flat portions joined by a pair of spaced elongated folds, said stylet is positioned adjacent the interior of one of said folds to facilitate the formation of one continuous spiral wrapping of the flattened balloon about the stylet.
Claim 33
Dependent Claim
133 words
An intra-aortic balloon assembly comprising a balloon having a distal end and a proximal end; a catheter tube having a distal end joined to the proximal end of said balloon; the distal end of the balloon terminating in a tip; a stylet extending between said tip and the proximal end of said catheter tube; the ends of the balloon being offset from the intermediate portion of said balloon to displace the stylet from the longitudinal axis of the balloon so that when the balloon is collapsed to a flat configuration defined by first and second flat portions joined by a pair of spaced elongated folds, said stylet is positioned adjacent the interior of one of said folds to facilitate the formation of one continuous spiral wrapping of the flattened balloon about the stylet.
Claim 34
Dependent Claim
15 words
The intra-aortic balloon assembly of claim 28 wherein said stylet is a hollow tubular member.
Claim 35
Dependent Claim
30 words
The intra-aortic balloon assembly of claim 29 wherein said tip has an opening communicating with the hollow interior of said tubular stylet to permit insertion of a guide wire therethrough.
Claim 36
Dependent Claim
48 words
The intra-aortic balloon assembly of claim 28 further comprising a locating indicia on the exterior of said catheter at a location sufficiently remote from said balloon to indicate the direction which the balloon extends away from said stylet to facilitate proper orientation of the balloon within the body.
Claim 37
Dependent Claim
52 words
The intra-aortic balloon assembly of claim 28 further comprising a locating indicia on the exterior of a coupling joined to said catheter at a location sufficiently remote from said balloon to indicate the direction which the balloon extends away from said stylet to facilitate proper orientation of the balloon within the body.
Claim 38
Dependent Claim
14 words
The apparatus of claim 32 wherein said sticky substance is nontoxic to the patient.
Claim 39
Dependent Claim
61 words
The intra-aortic balloon of claim 28 wherein a sticky substance is deposited upon the exterior surface of said balloon to cause the balloon, when wrapped after application of said substance, to retain said wrapped condition; and said sticky substance being dissolvable in the bloodstream to release the balloon from the wrapped condition when the wrapped balloon is inserted into the body.
References Cited (Backward Citations)
USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 1989-03-17 | 1989-09-16 | 1990-03-18 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 1993-03-17 | 1993-09-16 | 1994-03-18 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 1997-03-17 | 1997-09-16 | 1998-03-18 | $7700.00 | Window Closed / Lapsed |