US20020165574A1
Expired / Lapsed
US
⏱️ 0.0 years remaining
Emboli protection devices and related methods of use
Assignee: St Jude Medical Cardiology Division Inc
•
Filing: 2001-08-29
•
Granted: —
•
Expires: 2021-08-29
Abstract
Abstract An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. The evacuation sheath assembly includes an elongated tube defining an evacuation lumen having proximal and distal ends. A proximal sealing surface is provided on a proximal portion of the tube and is configured to form a seal with a lumen of a guided catheter. A distal sealing surface is provided on a distal portion of the tube and is configured to form a seal with a blood vessel. Obturator assemblies and infusion catheter assemblies are provided to be used with the evacuation sheath assembly. A method of treatment of a blood vessel using the evacuation sheath assembly includes advancing the evacuation sheath assembly into the blood vessel through a guide catheter. Normal antegrade blood flow in the blood vessel proximate to the stenosis is stopped and the stenosis is treated. Retrograde blood flow is induced within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly. If necessary to increase retrograde flow, the coronary sinus may be at least partially occluded. Alternatively, antegrade flow may be permitted while flow is occluded at the treatment site.
Inventors
- 👤 Thomas Ressemann
- 👤 Steven Hackett
- 👤 Andrew Dusbabek
- 👤 Scott Olson
- 👤 Peter Keith
- 👤 Dennis Wahr
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-22 23:16
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/12; A61B17/12022; A61B17/12027; A61B17/1204; A61B17/12045; A61B17/12099; A61B17/12109; A61B17/12131; A61B17/12136; A61B17/22; A61B2017/12127; A61B2017/22051; A61B2017/22065; A61B2017/22067; A61B2017/22079; A61B2017/22082; A61B2017/22084; A61B2217/00; A61B2217/002; A61B2217/005; A61B2217/007; A61B90/00; A61B90/39; A61F; A61F2/00; A61F2/95
Claims Analysis
Total Claims: 84
Claim 1
Independent Claim
91 words
1 . A method of treatment of a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; stopping normal antegrade blood flow in the blood vessel proximate to the stenosis; advancing a therapeutic catheter into the blood vessel; treating the stenosis with the therapeutic catheter; advancing an infusion catheter to a location distal to the stenosis; infusing the blood vessel with a fluid supplied by the infusion catheter; and inducing retrograde flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.
Claim 2
Dependent Claim
91 words
1 . A method of treatment of a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; stopping normal antegrade blood flow in the blood vessel proximate to the stenosis; advancing a therapeutic catheter into the blood vessel; treating the stenosis with the therapeutic catheter; advancing an infusion catheter to a location distal to the stenosis; infusing the blood vessel with a fluid supplied by the infusion catheter; and inducing retrograde flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.
Claim 3
Dependent Claim
27 words
2 . The method of claim 1 , wherein advancing the infusion catheter includes advancing the infusion catheter through a distal end of the evacuation sheath assembly.
Claim 4
Dependent Claim
30 words
3 . The method of claim 1 , wherein stopping blood flow includes creating a first seal between a distal portion of the evacuation sheath assembly and the blood vessel.
Claim 5
Dependent Claim
31 words
4 . The method of claim 3 , wherein stopping blood flow further comprises creating a second seal between a guide catheter and a proximal portion of the evacuation sheath assembly.
Claim 6
Dependent Claim
21 words
5 . The method of claim 1 , wherein inducing retrograde flow includes applying a vacuum through the evacuation sheath assembly.
Claim 7
Dependent Claim
20 words
6 . The method of claim 1 , wherein treating the stenosis includes advancing an angioplasty catheter to the stenosis.
Claim 8
Dependent Claim
21 words
7 . The method of claim 1 , wherein treating the stenosis includes advancing a stent delivery system to the stenosis.
Claim 9
Dependent Claim
32 words
8 . The method of claim 1 , wherein inducing retrograde flow includes venting pressure in a collection device in fluid communication with the blood vessel with normal antegrade blood flow stopped.
Claim 10
Dependent Claim
20 words
9 . The method of claim 8 , wherein inducing retrograde flow further includes applying suction to the collection device.
Claim 11
Dependent Claim
16 words
10 . The method of claim 1 , wherein the blood vessel is a coronary artery.
Claim 12
Dependent Claim
17 words
11 . The method of claim 1 , wherein the blood vessel is a saphenous vein graft.
Claim 13
Dependent Claim
26 words
12 . The method of claim 1 , wherein the step of stopping normal antegrade flow is performed prior to advancing a device across the stenosis.
Claim 14
Dependent Claim
30 words
13 . The method of claim 1 , wherein infusing the blood vessel with a fluid includes delivering a fluid through at least one infusion port of the infusion catheter.
Claim 15
Dependent Claim
28 words
14 . The method of claim 1 , wherein infusing the blood vessel with a fluid includes delivering the fluid to a location distal to the treated stenosis.
Claim 16
Dependent Claim
23 words
15 . The method of claim 1 , wherein infusing the blood vessel with a fluid includes infusing saline into the blood vessel.
Claim 17
Dependent Claim
24 words
16 . The method of claim 1 , wherein infusing the blood vessel with a fluid includes infusing whole blood into the blood vessel.
Claim 18
Dependent Claim
24 words
17 . The method of claim 1 , wherein infusing the blood vessel with a fluid includes infusing radiopaque dye into the blood vessel.
Claim 19
Dependent Claim
39 words
18 . The method of claim 1 , wherein advancing the evacuation sheath assembly includes advancing the evacuation sheath assembly through a guide catheter, and further comprising applying a vacuum to the guide catheter prior to infusing the fluid.
Claim 20
Dependent Claim
27 words
19 . The method of claim 1 , further comprising inducing retrograde flow prior to advancing the infusion catheter to move debris proximal to the treated stenosis.
Claim 21
Dependent Claim
122 words
20 . A method for treating a blood vessel, comprising: positioning a guide catheter proximate to the blood vessel; positioning an evacuation sheath assembly within the blood vessel; stopping normal antegrade blood flow in the blood vessel proximate to the site; advancing an interventional catheter into the blood vessel to treat the site of the blood vessel; occluding blood flow at the site with the interventional catheter; permitting antegrade blood flow around the guide catheter and evacuation sheath assembly toward the treatment site while blood flow is occluded by the interventional catheter; and applying a vacuum to the evacuation sheath assembly to carry embolic debris and antegrade blood flow into the evacuation sheath while blood flow is occluded by the interventional catheter.
Claim 22
Dependent Claim
122 words
20 . A method for treating a blood vessel, comprising: positioning a guide catheter proximate to the blood vessel; positioning an evacuation sheath assembly within the blood vessel; stopping normal antegrade blood flow in the blood vessel proximate to the site; advancing an interventional catheter into the blood vessel to treat the site of the blood vessel; occluding blood flow at the site with the interventional catheter; permitting antegrade blood flow around the guide catheter and evacuation sheath assembly toward the treatment site while blood flow is occluded by the interventional catheter; and applying a vacuum to the evacuation sheath assembly to carry embolic debris and antegrade blood flow into the evacuation sheath while blood flow is occluded by the interventional catheter.
Claim 23
Dependent Claim
25 words
21 . The method of claim 20 , wherein stopping normal antegrade blood flow is performed prior to advancing a device across the treatment site.
Claim 24
Dependent Claim
23 words
22 . The method of claim 20 , further including applying a vacuum to the evacuation sheath assembly prior to occluding blood flow.
Claim 25
Dependent Claim
16 words
23 . The method of claim 22 , wherein the blood vessel is a coronary artery.
Claim 26
Dependent Claim
17 words
24 . The method of claim 22 , wherein the blood vessel is a saphenous vein graft.
Claim 27
Dependent Claim
23 words
25 . The method of claim 22 , further comprising treating the site in the blood vessel, the treating including inflating a balloon.
Claim 28
Dependent Claim
21 words
26 . The method of claim 25 , further comprising deflating the balloon after treating the area of the blood vessel.
Claim 29
Dependent Claim
20 words
27 . The method of claim 26 , wherein occluding blood flow includes re-inflating the balloon of the interventional catheter.
Claim 30
Dependent Claim
51 words
28 . The method of claim 22 , wherein stopping normal antegrade blood flow includes creating a first seal between a distal portion of the evacuation sheath assembly and the blood vessel and includes creating a second seal between a proximal portion of the evacuation sheath assembly and the guide catheter.
Claim 31
Dependent Claim
18 words
29 . The method of claim 28 , wherein permitting antegrade blood flow includes releasing the first seal.
Claim 32
Dependent Claim
23 words
30 . The method of claim 22 , wherein advancing the interventional catheter includes advancing the interregional catheter through the evacuation sheath assembly.
Claim 33
Dependent Claim
92 words
31 . An evacuation sheath assembly, comprising: an elongate hollow member having proximal and distal ends, first and second lumens, and first and second sealing members, wherein the proximal end is flared, and wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing members; and a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.
Claim 34
Dependent Claim
92 words
31 . An evacuation sheath assembly, comprising: an elongate hollow member having proximal and distal ends, first and second lumens, and first and second sealing members, wherein the proximal end is flared, and wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing members; and a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.
Claim 35
Dependent Claim
17 words
32 . The assembly of claim 31 , wherein the first and second sealing members are balloons.
Claim 36
Dependent Claim
17 words
33 . The assembly of claim 31 , wherein the first and second sealing members are elastomeric.
Claim 37
Dependent Claim
40 words
34 . The assembly of claim 31 , wherein the first sealing member is located on a proximal portion of the elongated hollow member and the second sealing member is located on a distal portion of the elongated hollow member.
Claim 38
Dependent Claim
87 words
35 . An evacuation sheath assembly, comprising: an elongate hollow member supported by a kink-resisting coil and having first and second lumens, and first and second sealing members, wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing members; and a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.
Claim 39
Dependent Claim
87 words
35 . An evacuation sheath assembly, comprising: an elongate hollow member supported by a kink-resisting coil and having first and second lumens, and first and second sealing members, wherein the first lumen is an evacuation lumen configured to be placed in fluid communication with a bloodstream and wherein the second lumen is an inflation lumen in fluid communication with at least one of the first and second sealing members; and a shaft in fluid communication with the inflation lumen and configured to connect to an inflation source.
Claim 40
Dependent Claim
28 words
36 . The assembly of claim 35 , wherein a distal end of the elongated hollow member is perpendicular to a longitudinal axis of the elongated hollow member.
Claim 41
Dependent Claim
27 words
37 . The assembly of claim 36 , wherein one of said first and second sealing members is adjacent the distal end of the elongated hollow member.
Claim 42
Dependent Claim
84 words
38 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; an obturator having a proximal end and a distal end, wherein the distal end includes a distal tip having a first tapering diameter; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein the evacuation sheath assembly has a second diameter greater than the first tapering diameter.
Claim 43
Dependent Claim
84 words
38 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; an obturator having a proximal end and a distal end, wherein the distal end includes a distal tip having a first tapering diameter; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein the evacuation sheath assembly has a second diameter greater than the first tapering diameter.
Claim 44
Dependent Claim
17 words
39 . The combination of claim 38 , wherein the distal tip is a flexible, steerable tip.
Claim 45
Dependent Claim
56 words
40 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein a proximal end of the evacuation lumen is flared.
Claim 46
Dependent Claim
56 words
40 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein a proximal end of the evacuation lumen is flared.
Claim 47
Dependent Claim
30 words
41 . The combination of claim 40 , wherein the flared end of the evacuation lumen is configured to isolate fluid communication between the blood vessel and the catheter lumen.
Claim 48
Dependent Claim
27 words
42 . The combination of claim 40 , wherein the flared end of the evacuation sheath assembly is configured to seal against the lumen of the catheter.
Claim 49
Dependent Claim
31 words
43 . The combination of claim 40 , wherein the first sealing member includes a proximal portion of the evacuation sheath assembly configured to seal against the lumen of the catheter.
Claim 50
Dependent Claim
24 words
44 . The combination of claim 40 , wherein the second sealing member is located on a distal portion of the evacuation sheath assembly.
Claim 51
Dependent Claim
18 words
45 . The combination of claim 40 , wherein the first and second sealing members include expandable surfaces.
Claim 52
Dependent Claim
28 words
46 . The combination of claim 40 , wherein the second sealing member is configured to create a seal between the evacuation sheath assembly and the blood vessel.
Claim 53
Dependent Claim
26 words
47 . The combination of claim 40 , wherein a distal end of the evacuation lumen is perpendicular to a longitudinal axis of the evacuation lumen.
Claim 54
Dependent Claim
22 words
48 . The combination of claim 47 , wherein the second sealing member is adjacent the distal end of the evacuation lumen.
Claim 55
Dependent Claim
86 words
49 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; an obturator having a proximal end and a distal end, wherein the distal end includes a balloon and distal tip having a first tapering diameter; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein the evacuation sheath assembly has a second diameter greater than the first tapering diameter.
Claim 56
Dependent Claim
86 words
49 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a catheter having a lumen; an obturator having a proximal end and a distal end, wherein the distal end includes a balloon and distal tip having a first tapering diameter; and an evacuation sheath assembly configured to move within the lumen of the catheter and having an evacuation lumen and first and second sealing members, wherein the evacuation sheath assembly has a second diameter greater than the first tapering diameter.
Claim 57
Dependent Claim
21 words
50 . The combination of claim 49 , wherein the balloon is configured to form a seal with the evacuation lumen.
Claim 58
Dependent Claim
21 words
51 . The combination of claim 49 , wherein the balloon is configured to expand a treatment site prior to treatment.
Claim 59
Dependent Claim
124 words
52 . A method of treatment of a blood vessel, comprising: advancing a guide catheter proximate to the blood vessel; advancing an evacuation sheath assembly through the guide catheter and into the blood vessel while retaining a proximal portion of the evacuation sheath assembly within the guide catheter; at least partially occluding the coronary sinus; creating a seal between a distal portion of the evacuation sheath assembly and the blood vessel; stopping normal antegrade blood flow within the blood vessel; treating a stenosis within the blood vessel; causing retrograde flow within the blood vessel to thereby remove embolic material dislodged during the treating and carried by the retrograde flow into the evacuation sheath assembly; and re-establishing normal antegrade blood flow within the blood vessel.
Claim 60
Dependent Claim
124 words
52 . A method of treatment of a blood vessel, comprising: advancing a guide catheter proximate to the blood vessel; advancing an evacuation sheath assembly through the guide catheter and into the blood vessel while retaining a proximal portion of the evacuation sheath assembly within the guide catheter; at least partially occluding the coronary sinus; creating a seal between a distal portion of the evacuation sheath assembly and the blood vessel; stopping normal antegrade blood flow within the blood vessel; treating a stenosis within the blood vessel; causing retrograde flow within the blood vessel to thereby remove embolic material dislodged during the treating and carried by the retrograde flow into the evacuation sheath assembly; and re-establishing normal antegrade blood flow within the blood vessel.
Claim 61
Dependent Claim
27 words
53 . The method of claim 52 , further comprising creating a second seal between the proximal portion of the evacuation sheath assembly and the guide catheter.
Claim 62
Dependent Claim
25 words
54 . The method of claim 52 , wherein at least partially occluding the coronary sinus includes advancing an occlusion catheter into the coronary sinus.
Claim 63
Dependent Claim
28 words
55 . The method of claim 52 , wherein at least partially occluding the coronary sinus includes expanding a balloon of an occlusion catheter within the coronary sinus.
Claim 64
Dependent Claim
67 words
56 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein the open distal end of the evacuation lumen is perpendicular to a longitudinal axis of the evacuation lumen.
Claim 65
Dependent Claim
67 words
56 . An evacuation sheath assembly, comprising: an elongated tube defining an evacuation lumen having open proximal and distal ends and an inflation lumen having an open proximal end and a closed distal end; and at least one inflatable sealing surface in fluid communication with the inflation lumen; wherein the open distal end of the evacuation lumen is perpendicular to a longitudinal axis of the evacuation lumen.
Claim 66
Dependent Claim
74 words
57 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a guide catheter having a lumen; an evacuation sheath assembly configured to move within the lumen of the guide catheter and having an evacuation lumen and first and second sealing surfaces; and an infusion catheter assembly having an infusion lumen and at least one infusion port, the infusion catheter assembly being configured to move within the evacuation lumen.
Claim 67
Dependent Claim
74 words
57 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a guide catheter having a lumen; an evacuation sheath assembly configured to move within the lumen of the guide catheter and having an evacuation lumen and first and second sealing surfaces; and an infusion catheter assembly having an infusion lumen and at least one infusion port, the infusion catheter assembly being configured to move within the evacuation lumen.
Claim 68
Dependent Claim
74 words
58 . An infusion catheter assembly comprising: a proximal shaft portion having a proximal infusion lumen; and a distal shaft portion connected to a distal end of the proximal shaft portion, the distal shaft portion including a distal infusion lumen in flow communication with the proximal infusion lumen, at least one infusion port, and a guidewire lumen, wherein the guidewire lumen is shorter than the combined length of the proximal and distal infusion lumens.
Claim 69
Dependent Claim
74 words
58 . An infusion catheter assembly comprising: a proximal shaft portion having a proximal infusion lumen; and a distal shaft portion connected to a distal end of the proximal shaft portion, the distal shaft portion including a distal infusion lumen in flow communication with the proximal infusion lumen, at least one infusion port, and a guidewire lumen, wherein the guidewire lumen is shorter than the combined length of the proximal and distal infusion lumens.
Claim 70
Dependent Claim
64 words
59 . A method of treatment of a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; maintaining elevated pressure in the coronary sinus; stopping normal antegrade blood flow in the blood vessel proximate to the stenosis; treating the stenosis; and inducing retrograde blood flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.
Claim 71
Dependent Claim
64 words
59 . A method of treatment of a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; maintaining elevated pressure in the coronary sinus; stopping normal antegrade blood flow in the blood vessel proximate to the stenosis; treating the stenosis; and inducing retrograde blood flow within the blood vessel to carry embolic material dislodged during treating into the evacuation sheath assembly.
Claim 72
Dependent Claim
24 words
60 . The method of claim 59 , wherein stopping normal antegrade blood flow is performed prior to advancing a device across the stenosis.
Claim 73
Dependent Claim
22 words
61 . The method of claim 59 , wherein maintaining elevated pressure in the coronary sinus includes preventing closure of venous valves.
Claim 74
Dependent Claim
25 words
62 . The method of claim 59 , wherein maintaining elevated pressure in the coronary sinus includes advancing an occlusion catheter into the coronary sinus.
Claim 75
Dependent Claim
26 words
63 . The method of claim 62 , wherein maintaining elevated pressure in the coronary sinus further includes inflating an occlusion balloon in the coronary sinus.
Claim 76
Dependent Claim
28 words
64 . The method of claim 59 , wherein maintaining elevated pressure in the coronary sinus includes occluding the coronary sinus prior to stopping normal antegrade blood flow.
Claim 77
Dependent Claim
37 words
65 . The method of claim 59 , wherein treating the stenosis includes inflating a stent balloon, and wherein maintaining elevated pressure in the coronary sinus includes occluding the coronary sinus prior to deflating the stent balloon.
Claim 78
Dependent Claim
59 words
66 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a guide catheter having a lumen; an evacuation sheath assembly configured to move within the lumen of the guide catheter and having an evacuation lumen and first and second sealing surfaces; and an infusion catheter assembly configured to move within the evacuation lumen.
Claim 79
Dependent Claim
59 words
66 . A combination for isolating fluid communication between a blood vessel and a catheter, comprising: a guide catheter having a lumen; an evacuation sheath assembly configured to move within the lumen of the guide catheter and having an evacuation lumen and first and second sealing surfaces; and an infusion catheter assembly configured to move within the evacuation lumen.
Claim 80
Dependent Claim
96 words
67 . A method of treating a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; creating a first seal between the blood vessel and the evacuation sheath assembly; advancing an interventional device across a stenosis to be treated; treating the stenosis; inducing retrograde flow at the stenosis; establishing a second seal between the blood vessel and the interventional device; releasing the first seal to permit antegrade blood flow toward the treatment site; and applying suction to carry embolic material dislodged during treating and the antegrade blood flow into the evacuation sheath assembly.
Claim 81
Dependent Claim
96 words
67 . A method of treating a blood vessel, comprising: advancing an evacuation sheath assembly into the blood vessel; creating a first seal between the blood vessel and the evacuation sheath assembly; advancing an interventional device across a stenosis to be treated; treating the stenosis; inducing retrograde flow at the stenosis; establishing a second seal between the blood vessel and the interventional device; releasing the first seal to permit antegrade blood flow toward the treatment site; and applying suction to carry embolic material dislodged during treating and the antegrade blood flow into the evacuation sheath assembly.
Claim 82
Dependent Claim
20 words
68 . The method of claim 67 , wherein treating the stenosis includes expanding a balloon of the interventional device.
Claim 83
Dependent Claim
23 words
69 . The method of claim 68 , wherein expanding the balloon includes forming a seal between the blood vessel and the balloon.
Claim 84
Dependent Claim
15 words
70 . The method of claim 69 , wherein inducing retrograde flow deflating the balloon.
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