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US5261878A Expired / Lapsed US ⏱️ 0.0 years remaining

Double balloon pediatric ductus arteriosus stent catheter and method of using the same

Assignee: CALIFORNIA A CORP OF, University of, Regents of
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Filing: 1992-05-19
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Granted: 1993-11-16
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Expires: 2012-05-19
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Abstract

Abstract A cardiac catheter for use in maintaining the patency of the ductus arteriosus in infants is provided with two inflatable balloons, a distal end balloon and a stent balloon. Each balloon is independently inflatable. The stent is carried temporarily on the stent balloon and is delivered by the catheter to the site of the ductus arteriosus. Expansion of the stent balloon expands the stent and places it at the target site. The stent balloon is confidently and reliably placed in the ductus arteriosus by first inflating the distal end balloon and withdrawing the catheter until abuts the opening of the ductus arteriosus through which it has been previously disposed. When this abutment is realized, the stent balloon is necessarily positioned appropriately within the ductus arteriosus. While maintaining the inflation of the distal end balloon, the stent balloon is inflated and the stent placed. After placement, both the distal end balloon and stent balloon are deflated and the catheter withdrawn.

Inventors

  • 👤 Alvaro Galindo

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 14:19
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1011

Claims Analysis

Total Claims: 23
Claim 1
Independent Claim 116 words
A catheter for use in maintaining patency of the ductus arteriosus comprising: a catheter body having a proximal end and a distal end; an inflatable distal end balloon disposed on said distal end of said catheter body; an inflatable stent balloon disposed near said distal end of said catheter body proximate to said distal end balloon; means for selectively inflating said distal end balloon and stent balloon; and an expandable and permanently implantable stent disposed on said stent balloon, said expandable stent assuming a permanent expanded configuration upon inflation of said stent balloon, whereby said stent disposed on said stent balloon is adapted to be reliably and confidently positioned within said ductus arteriosus and installed therein.
Claim 2
Dependent Claim 116 words
A catheter for use in maintaining patency of the ductus arteriosus comprising: a catheter body having a proximal end and a distal end; an inflatable distal end balloon disposed on said distal end of said catheter body; an inflatable stent balloon disposed near said distal end of said catheter body proximate to said distal end balloon; means for selectively inflating said distal end balloon and stent balloon; and an expandable and permanently implantable stent disposed on said stent balloon, said expandable stent assuming a permanent expanded configuration upon inflation of said stent balloon, whereby said stent disposed on said stent balloon is adapted to be reliably and confidently positioned within said ductus arteriosus and installed therein.
Claim 3
Dependent Claim 15 words
The catheter of claim 1 wherein said distal end balloon is generally spherical when inflated.
Claim 4
Dependent Claim 36 words
The catheter of claim 1 wherein said distal balloon has a shape and size such that, when said distal balloon is inflated, it assumes a predetermined size, said predetermined size being greater than said ductus arteriosus.
Claim 5
Dependent Claim 16 words
The catheter of claim 1 wherein said stent balloon is generally cylindrical in shape when inflated.
Claim 6
Dependent Claim 25 words
The catheter of claim 4 wherein said stent balloon has a longitudinal length along the axis of said cylindrical shape approximately equal to said stent.
Claim 7
Dependent Claim 22 words
The catheter of claim 1 wherein said stent balloon further comprises a radiographic opaque marker at one end of said stent balloon.
Claim 8
Dependent Claim 24 words
The catheter of claim 6 wherein said stent balloon has a pair of radiopaque markers, one marker at each end of said stent balloon.
Claim 9
Dependent Claim 66 words
The catheter of claim 1 wherein said means for selectively inflating said distal end balloon and said stent balloon comprises a corresponding plurality of ports communicated through said catheter body, said ports being disposed at said proximal end of said catheter body and communicated through said catheter body to said distal end balloon and stent balloon at or near said distal end of said catheter body.
Claim 10
Dependent Claim 26 words
The catheter of claim 1 further comprising means for communicating with said distal end of said catheter body from said proximal end of said catheter body.
Claim 11
Dependent Claim 45 words
The catheter of claim 9 wherein said means for communicating comprises a port disposed at said proximal end of said catheter body, a lumen being disposed through said catheter body and a distal end port being defined at said distal end of said catheter body.
Claim 12
Independent Claim 188 words
A method of delivering a stent to the ductus arteriosus of an infant comprising the steps of: providing a catheter having a catheter body with a proximal and distal end, said distal end being provided with an inflatable distal end balloon and proximate thereto an inflatable stent balloon; disposing a stent on said stent balloon so that said stent is temporarily secured to said catheter; disposing said distal end through said ductus arteriousus of said infant, said distal end being disposed completely through said ductus arteriosus into an adjacent artery; inflating said distal end balloon; withdrawing said distal end of said catheter through said ductus arteriosus until said distal end balloon abuts the opening of said ductus arteriosus to thereby prevent further withdrawal; inflating said stent balloon while maintaining said distal end balloon in an inflated condition and in abutment to said opening of said ductus arteriosus, said inflating stent balloon disposing said stent in said ductus arteriosus; deflating said stent balloon and said distal balloon; and removing said catheter from said ductus arteriosus, whereby said stent is confidently and reliably delivered and disposed to said ductus arteriosus.
Claim 13
Independent Claim 188 words
A method of delivering a stent to the ductus arteriosus of an infant comprising the steps of: providing a catheter having a catheter body with a proximal and distal end, said distal end being provided with an inflatable distal end balloon and proximate thereto an inflatable stent balloon; disposing a stent on said stent balloon so that said stent is temporarily secured to said catheter; disposing said distal end through said ductus arteriousus of said infant, said distal end being disposed completely through said ductus arteriosus into an adjacent artery; inflating said distal end balloon; withdrawing said distal end of said catheter through said ductus arteriosus until said distal end balloon abuts the opening of said ductus arteriosus to thereby prevent further withdrawal; inflating said stent balloon while maintaining said distal end balloon in an inflated condition and in abutment to said opening of said ductus arteriosus, said inflating stent balloon disposing said stent in said ductus arteriosus; deflating said stent balloon and said distal balloon; and removing said catheter from said ductus arteriosus, whereby said stent is confidently and reliably delivered and disposed to said ductus arteriosus.
Claim 14
Dependent Claim 47 words
The method of claim 11 further comprising the steps of providing said stent balloon with at least one radiographic opaque marker to delineate an end of said stent balloon, and observing said radiographic opaque marker under fluoroscopy to corroborate disposition of said stent within said ductus arteriosus.
Claim 15
Dependent Claim 38 words
The method of claim 12 wherein said step of providing said stent balloon with a radiographic opaque marker comprises the step of providing said stent balloon with separate radiographic opaque markers at each end of said stent balloon.
Claim 16
Dependent Claim 32 words
The method of claim 11 where said step of inflating said distal end balloon inflates said distal end balloon to a size and shape which prevents its withdrawal through said ductus arteriosus.
Claim 17
Dependent Claim 33 words
The method of claim 11 where in said step of inflating said distal end balloon and said stent balloon, said balloons are inflated through ports provided at said proximal end of said catheter.
Claim 18
Dependent Claim 93 words
A catheter for maintaining the patency of the ductus arteriosus in an infant comprising: positioning means for physically determining the position of said catheter, said positioning means being adapted to determine said position of said catheter within said ductus arteriosus of said infant; an expandable and implantable stent capable of assuming a permanent expanded configuration; and delivery means for disposing and configuring said stent in said ductus arteriosus to permanently maintain its patency, whereby said stent is adapted to be confidently and reliably disposed in said ductus arteriosus without regard to fluoroscopic visibility.
Claim 19
Dependent Claim 93 words
A catheter for maintaining the patency of the ductus arteriosus in an infant comprising: positioning means for physically determining the position of said catheter, said positioning means being adapted to determine said position of said catheter within said ductus arteriosus of said infant; an expandable and implantable stent capable of assuming a permanent expanded configuration; and delivery means for disposing and configuring said stent in said ductus arteriosus to permanently maintain its patency, whereby said stent is adapted to be confidently and reliably disposed in said ductus arteriosus without regard to fluoroscopic visibility.
Claim 20
Dependent Claim 27 words
The catheter of claim 16 wherein said positioning means comprises a selectively actuatable element configurable into a uniquely determined position relative to position to said ductus arteriosus.
Claim 21
Dependent Claim 52 words
The catheter of claim 17 wherein said selectively activatable element is disposed on a distal end of said catheter and is selectively activated when said distal end is disposed through and beyond said ductus arteriosus, said element then being configured after activation to said uniquely determined position relative to said ductus arteriosus.
Claim 22
Dependent Claim 16 words
The catheter of claim 16 wherein said delivery means is independently operable from said positioning means.
Claim 23
Dependent Claim 44 words
The catheter of claim 16 wherein said delivery means comprises a stent adapted for disposition within said ductus arteriosus, said stent being temporarily fixed to said delivery means and adapted to be selectively disposed within said ductus arteriosus by activation of said delivery means.

References Cited (Backward Citations)

US4456011A Cited
US4771765A Cited
US4741328A Cited
US4794928A Cited
US4976692A Cited

USPTO Annuity & Maintenance Windows

Annuity Stage Window Opens Payment Deadline Surcharge Period Until Estimated Fee Status
3.5 Years (Year 4) 1996-11-15 1997-05-17 1997-11-16 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2000-11-15 2001-05-17 2001-11-16 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2004-11-15 2005-05-17 2005-11-16 $7700.00 Window Closed / Lapsed

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