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US7004173B2 Expired / Lapsed US ⏱️ 0.0 years remaining

Catheter system for vascular re-entry from a sub-intimal space

Assignee: Cordis US Corp
•
Filing: 2001-12-05
•
Granted: 2006-02-28
•
Expires: 2021-12-05
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Abstract

Abstract A catheter system and corresponding methods are provided for accessing a blood vessel true lumen from a sub-intimal plane of the vessel. The catheter system includes visualization elements for determining the orientation of the true lumen with respect to the sub-intimal plane at an identified entry site from a position in the sub-intimal plane. The entry site is distal to a chronic total occlusion (CTO). The catheter system also includes a system for physically securing tissue of the sub-intimal plane at the entry site to the catheter system. The attaching system reduces or eliminates catheter float within the sub-intimal space. The catheter system further includes re-entry devices to establish and maintain a path from the sub-intimal plane back into the vessel true lumen.

Inventors

  • 👤 Kurt D. Sparks
  • 👤 Jeffrey L. Emery
  • 👤 Brent D. Seybold
  • 👤 David J. Kupiecki
  • 👤 C. Danielle Pinson
  • 👤 Allen W. Madsen
  • 👤 Michael D. Keleher
  • 👤 Sergio Salinas
  • 👤 Benjamin J. Clark
  • 👤 Matthew R. Selmon

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-23 05:41
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/32; A61B17/3205; A61B17/3207; A61B17/320783; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/00247; A61B2017/00252; A61B17/22; A61B2017/22072; A61B2017/22074; A61B2017/22077; A61B2017/22094; A61B2017/22095; A61B90/00; A61B90/36; A61B90/37; A61B2090/378; A61B2090/3782

Claims Analysis

Total Claims: 25
Claim 1
Independent Claim 170 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port; determining a radial position of the true lumen with respect to the port at the target entry site from a position in the sub-intimal plane using an imaging device of the catheter system; and forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.
Claim 2
Independent Claim 170 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port; determining a radial position of the true lumen with respect to the port at the target entry site from a position in the sub-intimal plane using an imaging device of the catheter system; and forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.
Claim 3
Dependent Claim 15 words
The method of claim 1 , wherein the imaging device is a rotational imaging device.
Claim 4
Dependent Claim 14 words
The method of claim 1 , wherein the imaging device is an ultrasonic device.
Claim 5
Dependent Claim 17 words
The method of claim 1 , wherein the imaging device is an optical coherence tomography (OCT) device.
Claim 6
Dependent Claim 16 words
The method of claim 1 , wherein the incising element is integral to the imaging device.
Claim 7
Dependent Claim 20 words
The method of claim 1 , wherein the incising element is separate from and arranged concentrically outside the imaging device.
Claim 8
Dependent Claim 30 words
The method of claim 1 , wherein determining the radial position includes use of an imaging device that is a fixed integral part of a body of the catheter system.
Claim 9
Dependent Claim 21 words
The method of claim 1 , wherein determining the radial position includes use of a fluoroscopic marker on the catheter system.
Claim 10
Dependent Claim 19 words
The method of claim 8 , wherein the fluoroscopic marker is located on a body of the catheter system.
Claim 11
Dependent Claim 22 words
The method of claim 8 , wherein the fluoroscopic marker is located on one or more working elements of the catheter system.
Claim 12
Dependent Claim 36 words
The method of claim 1 , further comprising evacuating fluid from the sub-intimal space and securing the tissue separating the sub-intimal space from the true lumen at the port by applying vacuum to the catheter lumen.
Claim 13
Dependent Claim 37 words
The method of claim 11 , further comprising invaginating the tissue separating the sub-intimal space from the true lumen into the port and into a distal interior region of the catheter system upon application of the vacuum.
Claim 14
Dependent Claim 19 words
The method of claim 1 , further comprising advancing a working element into the true lumen through the incision.
Claim 15
Dependent Claim 21 words
The method of claim 13 , wherein the working element includes at least one of a guide wire and a cannula.
Claim 16
Independent Claim 137 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port; and forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.
Claim 17
Independent Claim 137 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port; and forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.
Claim 18
Independent Claim 164 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal excising element that is translatable across a portion of the port; determining a radial position of the true lumen with respect to the port at the target entry site from a position in the sub-intimal plane using an imaging device of the catheter system; advancing the internal excising element along a portion of the port; and excising an area of tissue separating the sub-intimal space from the true lumen using the internal excising element, the excised area of tissue generating a pathway from the sub-intimal space to the true lumen.
Claim 19
Independent Claim 164 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal excising element that is translatable across a portion of the port; determining a radial position of the true lumen with respect to the port at the target entry site from a position in the sub-intimal plane using an imaging device of the catheter system; advancing the internal excising element along a portion of the port; and excising an area of tissue separating the sub-intimal space from the true lumen using the internal excising element, the excised area of tissue generating a pathway from the sub-intimal space to the true lumen.
Claim 20
Independent Claim 131 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal excising element that is translatable across a portion of the port; advancing the internal excising element along a portion of the port; and excising an area of tissue separating the sub-intimal space from the true lumen using the internal excising element, the excised area of tissue generating a pathway from the sub-intimal space to the true lumen.
Claim 21
Independent Claim 131 words
A method for forming a pathway from a sub-intimal space of a blood vessel into a true lumen of the blood vessel, comprising: positioning a catheter system within the sub-intimal space at a position proximate to a target entry site into the true lumen, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal excising element that is translatable across a portion of the port; advancing the internal excising element along a portion of the port; and excising an area of tissue separating the sub-intimal space from the true lumen using the internal excising element, the excised area of tissue generating a pathway from the sub-intimal space to the true lumen.
Claim 22
Independent Claim 208 words
A method for establishing a pathway through a chronic total occlusion of a blood vessel, the pathway connecting a first region of a true lumen of the blood vessel which is proximal to the occlusion to a second region of the true lumen of the blood vessel distal to the occlusion via an extra-luminal pathway within the vessel, comprising: forming a track longitudinally from the first region of the true lumen through the occlusion and into a sub-intimal space distal to the occlusion; positioning a catheter system within the sub-intimal space using the track, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port; determining a radial position of the true lumen with respect to the port using an imaging device of the catheter system; and forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.
Claim 23
Independent Claim 208 words
A method for establishing a pathway through a chronic total occlusion of a blood vessel, the pathway connecting a first region of a true lumen of the blood vessel which is proximal to the occlusion to a second region of the true lumen of the blood vessel distal to the occlusion via an extra-luminal pathway within the vessel, comprising: forming a track longitudinally from the first region of the true lumen through the occlusion and into a sub-intimal space distal to the occlusion; positioning a catheter system within the sub-intimal space using the track, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system, the catheter system further including an internal incising element that is translatable across a portion of the port; determining a radial position of the true lumen with respect to the port using an imaging device of the catheter system; and forming an incision in tissue separating the sub-intimal space from the true lumen using the internal incising element, the incision having separate and distinct end points and forming a pathway between the sub-intimal space and the true lumen, wherein the tissue remains external to the port subsequent to forming the incision.
Claim 24
Independent Claim 201 words
A method for establishing a pathway through a chronic total occlusion of a blood vessel, the pathway connecting a first region of a true lumen of the blood vessel which is proximal to the occlusion to a second region of the true lumen distal to the occlusion via an extra-luminal pathway within the vessel, comprising: forming a track longitudinally from the first region of the true lumen through the occlusion and into a sub-intimal space distal to the occlusion; positioning a catheter system within the sub-intimal space using the track, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system; determining a radial position of the true lumen with respect to the port using an imaging device of the catheter system; applying a vacuum through the catheter lumen and the port, evacuating fluid from the sub-intimal space and bringing the sub-intimal tissue into intimate contact with the port; and advancing a working element through the port and through the tissue separating the sub-intimal space and the second region of the true lumen and generating a pathway from the sub-intimal space to the second region of the true lumen.
Claim 25
Independent Claim 201 words
A method for establishing a pathway through a chronic total occlusion of a blood vessel, the pathway connecting a first region of a true lumen of the blood vessel which is proximal to the occlusion to a second region of the true lumen distal to the occlusion via an extra-luminal pathway within the vessel, comprising: forming a track longitudinally from the first region of the true lumen through the occlusion and into a sub-intimal space distal to the occlusion; positioning a catheter system within the sub-intimal space using the track, the catheter system including at least one lumen in communication with at least one port in a distal region of the catheter system; determining a radial position of the true lumen with respect to the port using an imaging device of the catheter system; applying a vacuum through the catheter lumen and the port, evacuating fluid from the sub-intimal space and bringing the sub-intimal tissue into intimate contact with the port; and advancing a working element through the port and through the tissue separating the sub-intimal space and the second region of the true lumen and generating a pathway from the sub-intimal space to the second region of the true lumen.

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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) 2009-02-27 2009-08-29 2010-02-28 $2000.00 Window Closed / Lapsed
7.5 Years (Year 8) 2013-02-27 2013-08-29 2014-02-28 $3760.00 Window Closed / Lapsed
11.5 Years (Year 12) 2017-02-27 2017-08-29 2018-02-28 $7700.00 Window Closed / Lapsed

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