US20040010280A1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Device to create proximal stasis
Assignee: Ev3 Inc
•
Filing: 2002-07-12
•
Granted: —
•
Expires: 2022-07-12
Abstract
Abstract A method and system of performing an intravascular procedure at a treatment site in a vessel of a patient. A device creates a seal to prevent the flow of blood during the treatment of vascular disease. A seal may be formed between the distal inside diameter of a sheath or catheter such as a guide catheter as well as within a vessel, such as an artery or vein. An elongated device having a distal portion extending from the catheter and having a fluid impermeable membrane disposed about at least the distal end of the device is used to seal the vessel. The system includes a device to occlude blood flow and a distal protection device to filter or remove embolic debris.
Inventors
- 👤 Daniel Adams
- 👤 Richard Kusleika
- 👤 Kent Anderson
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 01:51
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/12; A61B17/12022; A61B17/12027; A61B17/1204; A61B17/12131; A61B17/12136; A61B17/22; A61B17/221; A61F; A61F2/00; A61F2/01; A61F2/013; A61B17/34; A61B17/3417; A61B17/3421; A61B17/3439; A61B17/00234; A61B2017/00238; A61B2017/00243; A61B2017/00247; A61B2017/00252; A61B2017/22051; A61B2017/22054; A61B2017/22065; A61B2017/22067; A61F2002/018; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0006; A61F2230/0063; A61F2230/0069; A61F2230/0073; A61F2230/008; A61F2230/0093; A61M; A61M25/00; A61M25/10; A61M2025/1043; A61M2025/1052
Claims Analysis
Total Claims: 49
Claim 1
Independent Claim
198 words
1 . A method of performing an intravascular procedure at a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel; advancing the guide catheter through the vessel until a distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into a lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; occluding the flow of blood through the vessel with the sealing device; after blood flow has been occluded advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to a location distal to the treatment site; deploying the distal protection device; withdrawing the distal sealing portion of the sealing device into the guide catheter; advancing a vascular treatment device through the guide catheter to the treatment site; and performing the intravascular procedure with the treatment device.
Claim 2
Dependent Claim
198 words
1 . A method of performing an intravascular procedure at a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel; advancing the guide catheter through the vessel until a distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into a lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; occluding the flow of blood through the vessel with the sealing device; after blood flow has been occluded advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to a location distal to the treatment site; deploying the distal protection device; withdrawing the distal sealing portion of the sealing device into the guide catheter; advancing a vascular treatment device through the guide catheter to the treatment site; and performing the intravascular procedure with the treatment device.
Claim 3
Dependent Claim
30 words
2 . The method of claim 1 wherein in the step of providing a sealing device the distal sealing portion is expandable from a delivery configuration to a deployed configuration.
Claim 4
Dependent Claim
52 words
3 . The method of claim 1 wherein in the step of providing a sealing device the proximal sealing portion has a first diameter and the distal sealing portion has a second diameter when extended from the distal end of the guide catheter, the second diameter being larger that the first diameter.
Claim 5
Dependent Claim
22 words
4 . The method of claim 1 wherein in the step of providing a sealing device the sealing device comprises metal wire.
Claim 6
Dependent Claim
21 words
5 . The method of claim 4 wherein in the step of providing a sealing device the metal wire comprises nitinol.
Claim 7
Dependent Claim
39 words
6 . The method of claim 1 wherein in the step of providing a sealing device the sealing device further comprises a control element connected adjacent at least one of the distal and proximal ends of the sealing device.
Claim 8
Dependent Claim
14 words
7 . The method of claim 6 wherein the control element comprises a wire.
Claim 9
Dependent Claim
14 words
8 . The method of claim 6 wherein the control element comprises a tube.
Claim 10
Dependent Claim
35 words
9 . The method of claim 6 wherein the control element comprises an elongate proximal portion of the sealing device having a length sufficient to extend outside the patient during advancement of the sealing device.
Claim 11
Dependent Claim
23 words
10 . The method of claim 1 wherein in the step of providing a sealing device the sealing device comprises a flexible membrane.
Claim 12
Dependent Claim
78 words
11 . The method of claim 1 wherein in the step of providing a sealing element the distal sealing portion comprises a flexible membrane which is folded into the lumen of the sealing device, wherein the sealing device further includes a deployment member, and wherein the step of occluding the flow of blood comprises advancing the deployment member through the lumen of the sealing device to push the folded membrane out of the lumen of the sealing device.
Claim 13
Dependent Claim
40 words
12 . The method of claim 1 wherein in the step of providing a sealing device the sealing device comprises at least one flow window between the lumen of the sealing device and an exterior surface of the sealing device.
Claim 14
Dependent Claim
45 words
13 . The method of claim 1 wherein in the step of providing a sealing device the distal sealing portion is expandable from a delivery configuration to a deployed configuration and wherein the sealing device includes means to delay expansion of the distal sealing portion.
Claim 15
Dependent Claim
21 words
14 . The method of claim 13 wherein the delay means includes longitudinal restraining elements positioned adjacent the distal sealing portion.
Claim 16
Dependent Claim
54 words
15 . The method of claim 1 wherein the step of advancing the sealing device comprises inflating a balloon portion of a balloon catheter in the lumen of the sealing device until the sealing device is secured to the balloon catheter and then advancing the balloon catheter through the lumen of the guide catheter.
Claim 17
Dependent Claim
37 words
16 . The method of claim 1 wherein in the step of providing a sealing device the sealing device includes means to bias the proximal sealing portion outwardly to seal against the lumen of the guide catheter.
Claim 18
Dependent Claim
15 words
17 . The method of claim 16 wherein the biasing means comprises a spring wire.
Claim 19
Dependent Claim
15 words
18 . The method of claim 16 wherein the biasing means comprises open cell foam.
Claim 20
Dependent Claim
21 words
19 . The method of claim 16 wherein the biasing means comprises a locally thinned portion of the proximal sealing portion.
Claim 21
Dependent Claim
59 words
20 . The method of claim 1 wherein the treatment site is located adjacent an ostium of the vessel and wherein in the step of providing a sealing device the distal sealing portion has a first section with a first diameter sized to seal the vessel proximal to the ostium and a second section with a second larger diameter.
Claim 22
Dependent Claim
133 words
21 . A method of occluding the flow of blood in a vessel of a patient comprising: introducing an elongate sheath into the vessel, the sheath having an inner wall defining a lumen extending therethrough; advancing the sheath through the vessel until a distal end of the sheath is at a desired location in the vessel; introducing a sealing device into the lumen of the sheath, the sealing device having a proximal sealing portion which seals against the inner wall of the sheath and a self-expanding distal sealing portion and having a lumen extending therethrough; and advancing the sealing device through the lumen of the sheath until the distal sealing portion extends from a distal end of the sheath and expands to seal against the wall of the vessel to occlude blood flow.
Claim 23
Dependent Claim
133 words
21 . A method of occluding the flow of blood in a vessel of a patient comprising: introducing an elongate sheath into the vessel, the sheath having an inner wall defining a lumen extending therethrough; advancing the sheath through the vessel until a distal end of the sheath is at a desired location in the vessel; introducing a sealing device into the lumen of the sheath, the sealing device having a proximal sealing portion which seals against the inner wall of the sheath and a self-expanding distal sealing portion and having a lumen extending therethrough; and advancing the sealing device through the lumen of the sheath until the distal sealing portion extends from a distal end of the sheath and expands to seal against the wall of the vessel to occlude blood flow.
Claim 24
Dependent Claim
80 words
22 . A sealing device for use in combination with a catheter to occlude fluid flow through a body lumen comprising an elongate body having a distal sealing portion and a proximal sealing portion and a lumen extending therethrough, the proximal sealing portion being sized to seal against a lumen of the catheter and the distal sealing portion being sized to seal against the body lumen when the distal sealing portion is extended from a distal end of the catheter.
Claim 25
Dependent Claim
80 words
22 . A sealing device for use in combination with a catheter to occlude fluid flow through a body lumen comprising an elongate body having a distal sealing portion and a proximal sealing portion and a lumen extending therethrough, the proximal sealing portion being sized to seal against a lumen of the catheter and the distal sealing portion being sized to seal against the body lumen when the distal sealing portion is extended from a distal end of the catheter.
Claim 26
Dependent Claim
89 words
23 . A system for occluding the flow of blood in a vessel of a human vascular system comprising: a catheter having proximal and distal ends and a lumen; and a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter.
Claim 27
Dependent Claim
89 words
23 . A system for occluding the flow of blood in a vessel of a human vascular system comprising: a catheter having proximal and distal ends and a lumen; and a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter.
Claim 28
Dependent Claim
137 words
24 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: a guide catheter having proximal and distal ends and a lumen; a sealing device having a distal sealing portion and a proximal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the guide catheter and the distal sealing portion being sized to seal against the wall of the vessel at a location proximal to the treatment site when the distal sealing portion is extended from the distal end of the guide catheter; and a distal protection device sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel distal to the treatment site.
Claim 29
Dependent Claim
137 words
24 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: a guide catheter having proximal and distal ends and a lumen; a sealing device having a distal sealing portion and a proximal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the guide catheter and the distal sealing portion being sized to seal against the wall of the vessel at a location proximal to the treatment site when the distal sealing portion is extended from the distal end of the guide catheter; and a distal protection device sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel distal to the treatment site.
Claim 30
Dependent Claim
130 words
25 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: a guide catheter having proximal and distal ends and a lumen; a sealing device having a lumen and having a proximal portion including proximal sealing means for sealing against the lumen of the guide catheter and a distal portion including distal sealing means for sealing against the wall of the vessel at a location proximal to the treatment site when the distal portion is extended from the distal end of the guide catheter; and a distal protection device sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel distal to the treatment site.
Claim 31
Dependent Claim
130 words
25 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: a guide catheter having proximal and distal ends and a lumen; a sealing device having a lumen and having a proximal portion including proximal sealing means for sealing against the lumen of the guide catheter and a distal portion including distal sealing means for sealing against the wall of the vessel at a location proximal to the treatment site when the distal portion is extended from the distal end of the guide catheter; and a distal protection device sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel distal to the treatment site.
Claim 32
Dependent Claim
213 words
26 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: a guide catheter having proximal and distal ends and a lumen; a sealing device having a distal sealing portion and a proximal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the guide catheter and the distal sealing portion being sized to seal against the wall of the vessel at a location proximal to the treatment site when the distal sealing portion is extended from the distal end of the guide catheter; a delivery catheter having distal and proximal ends and a lumen, the delivery catheter being sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel where its distal end is distal to the treatment site; and an elongate support member carrying an embolic protection device, the elongate support member and embolic protection device being sized to be slideably accommodated within the lumen of the delivery catheter, the embolic protection device being expandable from a delivery configuration when contained within the delivery catheter to a deployed configuration when extended from the distal end of the delivery catheter.
Claim 33
Dependent Claim
213 words
26 . A system for protecting a patient from emboli released during an intravascular procedure performed at a treatment site in a vessel of a patient comprising: a guide catheter having proximal and distal ends and a lumen; a sealing device having a distal sealing portion and a proximal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the guide catheter and the distal sealing portion being sized to seal against the wall of the vessel at a location proximal to the treatment site when the distal sealing portion is extended from the distal end of the guide catheter; a delivery catheter having distal and proximal ends and a lumen, the delivery catheter being sized to be delivered through the lumens of the guide catheter and sealing device to a location in the vessel where its distal end is distal to the treatment site; and an elongate support member carrying an embolic protection device, the elongate support member and embolic protection device being sized to be slideably accommodated within the lumen of the delivery catheter, the embolic protection device being expandable from a delivery configuration when contained within the delivery catheter to a deployed configuration when extended from the distal end of the delivery catheter.
Claim 34
Dependent Claim
245 words
27 . A method of performing an intravascular procedure at a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel, the guide catheter having proximal and distal ends and a lumen and a valve connected at the proximal end for opening and closing the lumen of the guide catheter to fluid flow; advancing the guide catheter through the vessel until the distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into the lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; blocking antegrade blood flow through the vessel with the sealing device; opening the valve on the guide catheter to create retrograde blood flow through the vessel; after antegrade blood flow has been blocked advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to a location distal to the treatment site; deploying the distal protection device; withdrawing the distal sealing portion of the sealing device into the guide catheter; advancing a vascular treatment device through the guide catheter to the treatment site; and performing the intravascular procedure with the treatment device.
Claim 35
Dependent Claim
245 words
27 . A method of performing an intravascular procedure at a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel, the guide catheter having proximal and distal ends and a lumen and a valve connected at the proximal end for opening and closing the lumen of the guide catheter to fluid flow; advancing the guide catheter through the vessel until the distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into the lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; blocking antegrade blood flow through the vessel with the sealing device; opening the valve on the guide catheter to create retrograde blood flow through the vessel; after antegrade blood flow has been blocked advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to a location distal to the treatment site; deploying the distal protection device; withdrawing the distal sealing portion of the sealing device into the guide catheter; advancing a vascular treatment device through the guide catheter to the treatment site; and performing the intravascular procedure with the treatment device.
Claim 36
Dependent Claim
229 words
28 . A method of performing an intravascular procedure at a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel, the guide catheter having proximal and distal ends and a lumen and a suction device connected to the lumen; advancing the guide catheter through the vessel until the distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into the lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; blocking antegrade blood flow through the vessel with the sealing device; operating the suction device to create retrograde blood flow through the vessel; after antegrade blood flow has been blocked advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to a location distal to the treatment site; deploying the distal protection device; withdrawing the distal sealing portion of the sealing device into the guide catheter; advancing a vascular treatment device through the guide catheter to the treatment site; and performing the intravascular procedure with the treatment device.
Claim 37
Dependent Claim
229 words
28 . A method of performing an intravascular procedure at a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel, the guide catheter having proximal and distal ends and a lumen and a suction device connected to the lumen; advancing the guide catheter through the vessel until the distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into the lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; blocking antegrade blood flow through the vessel with the sealing device; operating the suction device to create retrograde blood flow through the vessel; after antegrade blood flow has been blocked advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to a location distal to the treatment site; deploying the distal protection device; withdrawing the distal sealing portion of the sealing device into the guide catheter; advancing a vascular treatment device through the guide catheter to the treatment site; and performing the intravascular procedure with the treatment device.
Claim 38
Dependent Claim
109 words
29 . A system for creating retrograde flow of blood in a vessel of a human vascular system comprising: a catheter having proximal and distal ends and a lumen and a valve connected at the proximal end for opening and closing the lumen of the catheter to fluid flow; and a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter.
Claim 39
Dependent Claim
109 words
29 . A system for creating retrograde flow of blood in a vessel of a human vascular system comprising: a catheter having proximal and distal ends and a lumen and a valve connected at the proximal end for opening and closing the lumen of the catheter to fluid flow; and a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter.
Claim 40
Dependent Claim
99 words
30 . A system for creating retrograde flow of blood in a vessel of a human vascular system comprising: a catheter having proximal and distal ends and a lumen; a suction device connected to the lumen of the catheter; and a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter.
Claim 41
Dependent Claim
99 words
30 . A system for creating retrograde flow of blood in a vessel of a human vascular system comprising: a catheter having proximal and distal ends and a lumen; a suction device connected to the lumen of the catheter; and a sealing device having a proximal sealing portion and a distal sealing portion and a lumen, the proximal sealing portion being sized to seal against the lumen of the catheter and the distal sealing portion being sized to seal against the wall of the vessel when the distal sealing portion is extended from the distal end of the catheter.
Claim 42
Dependent Claim
166 words
31 . A method of delivering an embolic protection device to a desired location distal to a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel; advancing the guide catheter through the vessel until a distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into a lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; occluding the flow of blood through the vessel with the sealing device; and after blood flow has been occluded advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to the desired location distal to the treatment site.
Claim 43
Dependent Claim
166 words
31 . A method of delivering an embolic protection device to a desired location distal to a treatment site in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel; advancing the guide catheter through the vessel until a distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into a lumen of the guide catheter; advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter; occluding the flow of blood through the vessel with the sealing device; and after blood flow has been occluded advancing a distal protection device through the lumens of the guide catheter and the sealing device and through the vessel to the desired location distal to the treatment site.
Claim 44
Dependent Claim
120 words
32 . A method of occluding the flow of blood in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel; advancing the guide catheter through the vessel until a distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into a lumen of the guide catheter; and advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter and expands to seal against a wall of the vessel.
Claim 45
Dependent Claim
120 words
32 . A method of occluding the flow of blood in a vessel of a patient comprising: providing a sealing device having proximal and distal ends, a distal sealing portion and a proximal sealing portion and having a lumen extending therethrough; introducing a guide catheter into the vessel; advancing the guide catheter through the vessel until a distal end of the guide catheter is at a desired location proximal of the treatment site; introducing the sealing device into a lumen of the guide catheter; and advancing the sealing device through the lumen of the guide catheter until the distal sealing portion extends from the distal end of the guide catheter and expands to seal against a wall of the vessel.
Claim 46
Dependent Claim
16 words
33 . The system of claim 25 wherein the proximal sealing means comprises a spring wire.
Claim 47
Dependent Claim
16 words
34 . The system of claim 25 wherein the proximal sealing means comprises open cell foam.
Claim 48
Dependent Claim
91 words
35 . The system of claim 25 wherein a distance between a wall of the lumen of the sealing device and an exterior surface of a first section of the proximal portion defines a first wall thickness and wherein a distance between the wall of the lumen of the sealing device and an exterior surface of a second section of the proximal portion defines a second wall thickness which is less than the first wall thickness, the second section being biased radially outwardly, the proximal sealing means comprising the second section.
Claim 49
Dependent Claim
16 words
36 . The system of claim 25 wherein the distal sealing means comprises a self-expanding metal.
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