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EP0556564A2 Expired / Lapsed EP ⏱️ 0.0 years remaining

System and method for the percutaneous transluminal delivery and retrieval of a prosthetic occluder

Assignee: CR Bard Inc
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Filing: 1993-01-15
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Granted: —
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Expires: 2013-01-15
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Abstract

Abstract A system and method for percutaneous transluminal delivery and retrieval of a collapsible prosthetic occluder (209) includes a front-end loading delivery device (12), a control assembly (14) and an introducer and retrieval sheath assembly (16). The front-end loading delivery device includes a tapering lumen portion (26) and a smaller diameter distal lumen portion. An infusion port (30) communicates with the distal lumen portion immediately adjacent the distal end of the tapering lumen portion. A valve assembly (36) seals the delivery device lumen proximally of the collapsed occluder. The distal end of the front-end loading delivery device is inserted into the proximal end of an introducer and retrieval sheath assembly. A control assembly advances the occluder through the front-end loading delivery device, the introducer and retrieval sheath assembly and into the defect site. The retrieval sheath assembly is less flexible than the introducer sheath and is sufficiently rigid to evert the deployed occluder when retracted thereagainst.

Inventors

  • 👤 George Bourne
  • 👤 George Duval
  • 👤 Dennis Goodine
  • 👤 Gerry Ouellette
  • 👤 Gregory R. Whittaker

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-10-23 11:16
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/0057; A61B2017/00575; A61B2017/00592; A61B2017/00606; A61B2017/00619; A61B2017/00623; A61B2017/00831; A61B2017/00902

Claims Analysis

Total Claims: 50
Claim 1
Independent Claim 110 words
A front-end loading delivery device for transluminal delivery of a collapsible prosthetic occluder, comprising: a main body having a distal end, a proximal end and a lumen extending therethrough, a portion of said lumen being tapered inwardly toward a smaller diameter distal portion; an infusion port extending through said main body and in direct communication with said distal portion of said lumen; and a collapsible prosthetic device having a first configuration larger than said distal portion of said lumen and a second configuration that is smaller than said distal portion of said lumen, said collapsible prosthetic device being moveable in said second configuration through said distal portion of said lumen.
Claim 2
Dependent Claim 110 words
A front-end loading delivery device for transluminal delivery of a collapsible prosthetic occluder, comprising: a main body having a distal end, a proximal end and a lumen extending therethrough, a portion of said lumen being tapered inwardly toward a smaller diameter distal portion; an infusion port extending through said main body and in direct communication with said distal portion of said lumen; and a collapsible prosthetic device having a first configuration larger than said distal portion of said lumen and a second configuration that is smaller than said distal portion of said lumen, said collapsible prosthetic device being moveable in said second configuration through said distal portion of said lumen.
Claim 3
Dependent Claim 31 words
The front-end loading delivery device recited in claim 1 wherein said distal end is constructed and arranged for insertion into a hub at the proximal end of an introducer sheath lumen.
Claim 4
Dependent Claim 28 words
The front-end loading delivery device recited in claim 1 wherein said infusion port opens into said lumen distal portion immediately adjacent said inwardly tapered portion of said lumen.
Claim 5
Dependent Claim 20 words
The front-end loading delivery device recited in claim 1 wherein said distal portion of said lumen has a uniform diameter.
Claim 6
Dependent Claim 15 words
The front-end loading delivery device recited in claim 1 wherein said main body is transparent.
Claim 7
Dependent Claim 24 words
The front-end loading delivery device recited in claim 1 further including a valve for sealing said lumen proximally of said smaller diameter distal portion.
Claim 8
Dependent Claim 42 words
The front-end loading delivery device recited in claim 6 wherein said valve includes a compressible gland having a tapered outer portion constructed and arranged to closely fit in a non-compressed state within a proximal end of said tapered portion of said lumen.
Claim 9
Dependent Claim 23 words
The front-end loading delivery device recited in claim 7 wherein said compressible gland further includes a cylindrical portion proximally of said tapered portion.
Claim 10
Dependent Claim 44 words
The front-end loading delivery device recited in claim 6 wherein said valve includes a cap threadably mounted to said proximal end of said main body and having a lumen extending therethrough and a compressible gland having a lumen in alignment with said cap lumen.
Claim 11
Dependent Claim 38 words
The front-end loading delivery device recited in claim 9 wherein one of said cap and said gland has an annular groove and the other of said cap and said gland has an annular projection fitted within said groove.
Claim 12
Dependent Claim 15 words
The front-end loading delivery device recited in claim 9 wherein said cap is internally threaded.
Claim 13
Dependent Claim 22 words
The front-end loading delivery device recited in claim 11 wherein said cap includes a locking step projection distally of said internal threads.
Claim 14
Dependent Claim 38 words
The front-end loading delivery device recited in claim 9 wherein the perimeter of said cap lumen and said gland lumen in a non-compressed state is smaller than the perimeter of said second configuration of said collapsible prosthetic device.
Claim 15
Dependent Claim 19 words
The front-end loading delivery device recited in claim 1 wherein said tapered portion of said lumen is conically shaped.
Claim 16
Dependent Claim 15 words
The front-end loading delivery device recited in claim 1 wherein said distal end is rigid.
Claim 17
Dependent Claim 122 words
A control assembly for percutaneous transluminal delivery of an article to a defect site, comprising: an elongated shaft having a proximal end, a flexible distal end and a lumen extending therethrough, said flexible distal end being bendable to conform to a shape of a body lumen adjacent to the defect site; a locking wire extending through said lumen of said elongated shaft having a proximal end and a bulbous shaped locking member at a distal end which is extendable beyond said flexible distal end of said elongated shaft; the inner perimeter of a portion of said flexible distal end of said elongated shaft being adapted to lockingly hold said bulbous locking member and a bulbous shaped locking member of an associated article.
Claim 18
Dependent Claim 122 words
A control assembly for percutaneous transluminal delivery of an article to a defect site, comprising: an elongated shaft having a proximal end, a flexible distal end and a lumen extending therethrough, said flexible distal end being bendable to conform to a shape of a body lumen adjacent to the defect site; a locking wire extending through said lumen of said elongated shaft having a proximal end and a bulbous shaped locking member at a distal end which is extendable beyond said flexible distal end of said elongated shaft; the inner perimeter of a portion of said flexible distal end of said elongated shaft being adapted to lockingly hold said bulbous locking member and a bulbous shaped locking member of an associated article.
Claim 19
Dependent Claim 27 words
The control assembly recited in claim 16 wherein said portion of said flexible distal end of said elongated shaft includes a distal tip of said elongated shaft.
Claim 20
Dependent Claim 31 words
The control assembly recited in claim 16 wherein said portion of said flexible distal end of said elongated shaft is less flexible than an adjacent portion of said flexible distal end.
Claim 21
Dependent Claim 32 words
The control assembly recited in claim 18 wherein said flexible distal end of said elongated shaft is formed of a plastic material and said less flexible portion further contains a metallic material.
Claim 22
Dependent Claim 19 words
The control assembly recited in claim 19 wherein said metallic material containing less flexible portion includes a metal sleeve.
Claim 23
Dependent Claim 52 words
The control assembly recited in claim 20 wherein said bulbous shaped locking member includes an enlarged spherical portion of said locking wire distal end and said metal sleeve has an inner diameter greater than the diameter of said enlarged spherical portion but less than twice the diameter of said enlarged spherical portion.
Claim 24
Dependent Claim 22 words
The control assembly recited in claim 16 wherein said bulbous shaped locking member includes an enlarged spherical portion of said distal end.
Claim 25
Dependent Claim 56 words
The control assembly recited in claim 16 further comprising a handle connected to said proximal end of said elongated shaft and including a moveable member connected to said proximal end of said locking wire for reciprocally advancing and retracting said bulbous shaped locking member relative to said portion of said flexible distal end of said shaft.
Claim 26
Dependent Claim 30 words
The control assembly recited in claim 23 wherein said handle includes telescoping distal and proximal portions and a stop for limiting the displacement of said telescoping distal and proximal portions.
Claim 27
Dependent Claim 43 words
The control assembly recited in claim 24 wherein said stop includes a groove extending through the surface of one of said telescoping distal and proximal portions and a projection extending into said groove from said other of said telescoping distal and proximal portions.
Claim 28
Dependent Claim 26 words
The control assembly recited in claim 23 wherein said handle further includes means for releasably locking said telescoping distal and proximal portions relative to one another.
Claim 29
Dependent Claim 114 words
A percutaneous transluminal introducer and retrieval sheath assembly, comprising: an introducer sheath having a proximal end, a flexible distal end which is bendable to conform to a shape of a body lumen adjacent a defect site and a lumen extending therethrough; a retrieval sheath removeably mounted about said introducer sheath and having a lumen extending therethrough adapted to slidably receive said introducer sheath, a distal end of said retrieval sheath being less flexible than said flexible distal end of said introducer sheath; a positioning wire extendable through and beyond said introducer sheath lumen and having a distal tip connected to an article to be retrieved having a configuration larger than said introducer sheath lumen.
Claim 30
Dependent Claim 114 words
A percutaneous transluminal introducer and retrieval sheath assembly, comprising: an introducer sheath having a proximal end, a flexible distal end which is bendable to conform to a shape of a body lumen adjacent a defect site and a lumen extending therethrough; a retrieval sheath removeably mounted about said introducer sheath and having a lumen extending therethrough adapted to slidably receive said introducer sheath, a distal end of said retrieval sheath being less flexible than said flexible distal end of said introducer sheath; a positioning wire extendable through and beyond said introducer sheath lumen and having a distal tip connected to an article to be retrieved having a configuration larger than said introducer sheath lumen.
Claim 31
Dependent Claim 33 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 27 wherein said distal end of said removeably mounted retrieval sheath is positioned proximally of said flexible distal end of said introducer sheath.
Claim 32
Dependent Claim 89 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 27 wherein said removeably mounted retrieval sheath is moveable from a first position wherein said less flexible distal end of said removeably mounted retrieval sheath is proximal of said flexible distal end of said introducer sheath and said distal tip of said positioning wire to a second position wherein said less flexible distal end of said removeably mounted retrieval sheath is distal of said flexible distal end of said introducer sheath and said distal tip of said positioning wire.
Claim 33
Dependent Claim 31 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 27 further comprising a valve for sealing said proximal end of said lumen of said introducer sheath about said positioning wire.
Claim 34
Dependent Claim 38 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 27 further comprising a flange fixed to a proximal end of said removeably mounted retrieval sheath and having a lumen therethrough adapted to slidably receive said introducer sheath.
Claim 35
Dependent Claim 22 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 31 wherein said flange is tapered inwardly towards a distal tip thereof.
Claim 36
Dependent Claim 17 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 32 wherein said tapering flange is cone-shaped.
Claim 37
Dependent Claim 29 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 31 wherein said flange is releasably connected to a projection supported by a proximal end of said introducer sheath.
Claim 38
Dependent Claim 22 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 34 wherein said projection is tapered inwardly towards a distal tip thereof.
Claim 39
Dependent Claim 29 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 35 wherein said flange includes a proximal end adapted to receive said tapered projection in a releasable tight-fitting relationship.
Claim 40
Dependent Claim 24 words
The percutaneous transluminal introducer and retrieval assembly recited in claim 36 wherein said proximal end of said flange is more flexible than said projection.
Claim 41
Dependent Claim 140 words
A percutaneous transluminal delivery assembly, comprising: a front-end loading delivery device having a proximal end, a distal end and a lumen extending therethrough, a portion of said lumen tapering inwardly towards a smaller diameter distal portion; an introducer sheath having a flexible distal end, a proximal end and a lumen extending therethrough, said distal end of said delivery device being removeably mountable to a hub at a proximal end of said introducer sheath; a positioning wire moveable through said lumen of said delivery device and said lumen of said introducer sheath and having a distal tip connected to a collapsible prosthetic occluder; a valve for sealing a proximal end of said lumen of said delivery device about said positioning wire; and a valve for sealing said proximal end of said introducer lumen about said distal end of said delivery device.
Claim 42
Dependent Claim 140 words
A percutaneous transluminal delivery assembly, comprising: a front-end loading delivery device having a proximal end, a distal end and a lumen extending therethrough, a portion of said lumen tapering inwardly towards a smaller diameter distal portion; an introducer sheath having a flexible distal end, a proximal end and a lumen extending therethrough, said distal end of said delivery device being removeably mountable to a hub at a proximal end of said introducer sheath; a positioning wire moveable through said lumen of said delivery device and said lumen of said introducer sheath and having a distal tip connected to a collapsible prosthetic occluder; a valve for sealing a proximal end of said lumen of said delivery device about said positioning wire; and a valve for sealing said proximal end of said introducer lumen about said distal end of said delivery device.
Claim 43
Dependent Claim 41 words
The percutaneous transluminal introducer assembly recited in claim 38 wherein said valve for sealing said introducer sheath lumen includes a cap threadably mounted to said introducer sheath, a compressible gland and a washer disposed between said cap and said compressible gland.
Claim 44
Independent Claim 68 words
A method of delivering a prosthetic device into the lumen of a percutaneous transluminal introducer sheath, comprising: collapsing the prosthetic device in the lumen of a delivery device; infusing fluid through a port extending into the delivery device and in communication with the delivery device lumen to remove air bubbles from the collapsed prosthetic device; and advancing the prosthetic device from the delivery device into the introducer lumen.
Claim 45
Independent Claim 68 words
A method of delivering a prosthetic device into the lumen of a percutaneous transluminal introducer sheath, comprising: collapsing the prosthetic device in the lumen of a delivery device; infusing fluid through a port extending into the delivery device and in communication with the delivery device lumen to remove air bubbles from the collapsed prosthetic device; and advancing the prosthetic device from the delivery device into the introducer lumen.
Claim 46
Dependent Claim 36 words
The method of delivering a prosthetic device to a percutaneous transluminal introducer sheath recited in claim 40 further comprising the step of sealing a proximal end of the delivery device lumen prior to said infusing step.
Claim 47
Dependent Claim 43 words
The method of delivering a prosthetic device into a percutaneous transluminal introducer sheath recited in claim 41 wherein said infusing step includes the step of infusing liquid into the delivery device lumen in a direction perpendicular to the axis of the prosthetic device.
Claim 48
Dependent Claim 26 words
The method of delivering a prosthetic device to a percutaneous transluminal introducer sheath recited in claim 40 wherein the prosthetic device includes an umbrella shaped occluder.
Claim 49
Independent Claim 77 words
A method of percutaneous transluminal retrieval of a prosthetic device, comprising: providing a prosthetic device which is larger than the lumen of a flexible introducer sheath and which extends distally of the flexible introducer sheath; providing a less flexible retrieval sheath about the flexible introducer sheath; and retracting the introducer sheath and the prosthetic device against the less flexible retrieval catheter until the prosthetic device collapses into a configuration which is removable through the retrieval sheath lumen.
Claim 50
Independent Claim 77 words
A method of percutaneous transluminal retrieval of a prosthetic device, comprising: providing a prosthetic device which is larger than the lumen of a flexible introducer sheath and which extends distally of the flexible introducer sheath; providing a less flexible retrieval sheath about the flexible introducer sheath; and retracting the introducer sheath and the prosthetic device against the less flexible retrieval catheter until the prosthetic device collapses into a configuration which is removable through the retrieval sheath lumen.

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