Patent GB513521A successfully refreshed from Google Patents.
US20020188276A1
Expired / Lapsed
US
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Apparatus and methods for clot dissolution
Assignee: Covidien LP
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Filing: 2002-05-08
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Granted: —
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Expires: 2022-05-08
Abstract
Abstract Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, aspirate clot and fluid, and allow passage of a guidewire. Optionally, the catheter may also include a mechanical agitator for further disrupt clot in the presence of the thrombolytic agent. A flow resistor in the catheter provides for infusion and/or aspiration to be concentrated primarily at a clot treatment area in a blood vessel while also providing optional infusion and/or aspiration distal to the treatment area. In some embodiments, infusion, aspiration and guidewire passage occur through a common lumen. The thrombolytic agent, such as tPA, streptokinase, or urokinase, is directly released into the clot at the point where the agitator is engaging the clot. In this way, the thrombolytic activity of the agent is enhanced and the dissolution of the clot is improved.
Inventors
- 👤 Michael Evans
- 👤 Denise Demarais
- 👤 Dino De Cicco
- 👤 Kelvin Ning
- 👤 Alexander Khairkhahan
- 👤 Tyler Strang
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:43
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/0021; A61B; A61B17/00; A61B17/22; A61B17/32; A61B17/3205; A61B17/3207; A61B17/320758; A61B17/320725; A61B2017/22051; A61B2017/22065; A61B2017/22067; A61B2017/22082; A61B2017/22084; A61M25/0067; A61M25/0068; A61M25/007; A61M25/01; A61M25/0105
Claims Analysis
Total Claims: 82
Claim 1
Independent Claim
114 words
1 . Apparatus for disrupting clot over a luminal length of a blood vessel, the apparatus comprising: a catheter body having a proximal end, a distal end, and at least one lumen, the lumen having a distal-end opening for allowing passage of a guidewire and fluid flow and at least one side opening proximal to the distal-end opening for allowing fluid flow, wherein the distal-end opening and the at least one side opening allow preferential fluid flow through the at least one side opening; and a first radially expandable body between the distal-end opening and the at least one side opening for inhibiting flow of clot beyond the luminal length of the blood vessel.
Claim 2
Dependent Claim
114 words
1 . Apparatus for disrupting clot over a luminal length of a blood vessel, the apparatus comprising: a catheter body having a proximal end, a distal end, and at least one lumen, the lumen having a distal-end opening for allowing passage of a guidewire and fluid flow and at least one side opening proximal to the distal-end opening for allowing fluid flow, wherein the distal-end opening and the at least one side opening allow preferential fluid flow through the at least one side opening; and a first radially expandable body between the distal-end opening and the at least one side opening for inhibiting flow of clot beyond the luminal length of the blood vessel.
Claim 3
Dependent Claim
34 words
2 . Apparatus as in claim 1 , further comprising a flow resistor between the distal-end opening and the at least one side opening for inhibiting fluid flow through the at least one lumen.
Claim 4
Dependent Claim
46 words
3 . Apparatus as in claim 2 , wherein the flow resistor inhibits flow such that between about 0.1% and about 20% of fluid flows through the distal-end opening and between about 80% and about 99.9% of fluid flows through the at least one side opening.
Claim 5
Dependent Claim
21 words
4 . Apparatus as in claim 2 , wherein the flow resistor comprises a cylindrical material having at least one channel.
Claim 6
Dependent Claim
16 words
5 . Apparatus as in claim 4 , wherein the cylindrical material comprises an elastomeric material.
Claim 7
Dependent Claim
28 words
6 . Apparatus as in claim 4 , wherein the outer diameter of the cylindrical material is equal to the inner diameter of the at least one lumen.
Claim 8
Dependent Claim
29 words
7 . Apparatus as in claim 4 , wherein the at least one channel comprises a cylindrical hole having an inner diameter sufficient to allow passage of the guidewire.
Claim 9
Dependent Claim
20 words
8 . Apparatus as in claim 4 , wherein the at least one channel comprises one or more flexible slits.
Claim 10
Dependent Claim
33 words
9 . Apparatus as in claim 4 , wherein the at least one channel comprises a valve for allowing passage of the guidewire and one or more holes for allowing passage of fluid.
Claim 11
Dependent Claim
20 words
10 . Apparatus as in claim 2 , wherein the flow resistor comprises a membrane with at least one aperture.
Claim 12
Dependent Claim
61 words
11 . Apparatus as in claim 2 , wherein the flow resistor comprises a ball valve for partially blocking flow of fluid through the at least one lumen, the ball valve having at least one channel, a ball, and a widened area within the channel into which the ball may be displaced to allow passage of a guidewire through the channel.
Claim 13
Dependent Claim
69 words
12 . Apparatus as in claim 2 , wherein the flow resistor comprises a compliant membrane coupled to the at least one lumen, the compliant membrane communicating with an inflation lumen, the inflation lumen communicating with an inflation port, wherein inflation via the inflation port and inflation lumen moves the compliant membrane to partially or wholly block fluid flow through the at least one lumen of the catheter body.
Claim 14
Dependent Claim
34 words
13 . Apparatus as in claim 1 , wherein a cross-sectional area of the distal-end opening is between about 0.1% and about 20% of a cross-sectional area of the at least one side opening.
Claim 15
Dependent Claim
33 words
14 . Apparatus as in claim 1 , wherein the at least one side opening comprises one opening in the at least one lumen and in a side wall of the catheter body.
Claim 16
Dependent Claim
36 words
15 . Apparatus as in claim 1 , wherein the at least one side opening comprises a plurality of spaced-apart openings in the at least one lumen and in a side wall of the catheter body.
Claim 17
Dependent Claim
41 words
16 . Apparatus as in claim 1 , wherein the at least one lumen comprises a first lumen communicating with the distal-end opening and the at least one side opening and a second lumen communicating with at least one additional opening.
Claim 18
Dependent Claim
35 words
17 . Apparatus as in claim 16 , wherein a guidewire passes through the first lumen, an agent is distributed through the first lumen, and one or more substances are aspirated through the second lumen.
Claim 19
Dependent Claim
35 words
18 . Apparatus as in claim 16 , wherein a guidewire passes through the first lumen, one or more substances are aspirated through the first lumen, and an agent is distributed through the second lumen.
Claim 20
Dependent Claim
26 words
19 . Apparatus as in claim 1 , further comprising means for distributing an agent through the distal-end opening and the at least one side opening.
Claim 21
Dependent Claim
44 words
20 . Apparatus as in claim 17 , 18 or 19 , wherein the agent is a member selected from the group consisting of a thrombolytic agent, a fibrinolytic agent, a calcium dissolving agent, a gene therapy agent, and a group GP IIb/IIIa Inhibitor.
Claim 22
Dependent Claim
30 words
21 . Apparatus as in claim 1 , further comprising an agitator near the distal end of the catheter body for agitating clot over the length of the blood vessel.
Claim 23
Dependent Claim
15 words
22 . Apparatus as in claim 21 , wherein the agitator comprises a mechanical agitator.
Claim 24
Dependent Claim
18 words
23 . Apparatus as in claim 21 , wherein the agitator agitates at a frequency of 0-20,000 Hertz.
Claim 25
Dependent Claim
18 words
24 . Apparatus as in claim 21 , wherein the agitator comprises a rotatable and/or axially translatable agitator.
Claim 26
Dependent Claim
41 words
25 . Apparatus as in claim 24 , wherein the agitator comprises a resilient element which may be radially constrained to have a low profile or may be freed from radial constraint to have an enlarged profile having a non-linear geometry.
Claim 27
Dependent Claim
29 words
26 . Apparatus as in claim 24 , wherein the agitator comprises a resilient element which may be axially shortened to assume an enlarged profile having a non-linear geometry.
Claim 28
Dependent Claim
32 words
27 . Apparatus as in claim 25 or 26 , wherein the resilient element has a non-linear geometry selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random.
Claim 29
Dependent Claim
17 words
28 . Apparatus as in claim 1 , wherein the first radially expandable body comprises a balloon.
Claim 30
Dependent Claim
17 words
29 . Apparatus as in claim 1 , wherein the first radially expandable body comprises a filter.
Claim 31
Dependent Claim
36 words
30 . Apparatus as in claim 1 , further comprising a second radially expandable body, proximal to the at least one side opening, for inhibiting flow of clot beyond the luminal length of the blood vessel.
Claim 32
Dependent Claim
78 words
31 . Apparatus for disrupting clot over a luminal length of a blood vessel, the apparatus comprising: a catheter body having a proximal end, a distal end, and at least one lumen; means near the distal end of the catheter body for distributing an agent from the at least one lumen over the length of the blood vessel; and means near the distal end of the catheter body for resisting fluid flow through the at least one lumen.
Claim 33
Dependent Claim
78 words
31 . Apparatus for disrupting clot over a luminal length of a blood vessel, the apparatus comprising: a catheter body having a proximal end, a distal end, and at least one lumen; means near the distal end of the catheter body for distributing an agent from the at least one lumen over the length of the blood vessel; and means near the distal end of the catheter body for resisting fluid flow through the at least one lumen.
Claim 34
Dependent Claim
43 words
32 . Apparatus as in claim 31 , further comprising means near the distal end of the catheter body for mechanically agitating clot over the luminal length of the blood vessel, the mechanical agitating means extending along a length of the catheter body.
Claim 35
Dependent Claim
37 words
33 . Apparatus as in claim 31 , wherein the flow resisting means comprises a cylindrical material for partially blocking flow of fluid through the at least one lumen, the cylindrical material having at least one channel.
Claim 36
Dependent Claim
28 words
34 . Apparatus as in claim 33 , wherein the outer diameter of the cylindrical material is equal to the inner diameter of the at least one lumen.
Claim 37
Dependent Claim
29 words
35 . Apparatus as in claim 33 , wherein the at least one channel comprises a cylindrical hole having an inner diameter sufficient to allow passage of the guidewire.
Claim 38
Dependent Claim
28 words
36 . Apparatus as in claim 33 , wherein the at least one channel comprises one or more flexible slits to allow passage of the guidewire and fluid.
Claim 39
Dependent Claim
33 words
37 . Apparatus as in claim 33 , wherein the at least one channel comprises a valve for allowing passage of the guidewire and one or more holes for allowing passage of fluid.
Claim 40
Dependent Claim
21 words
38 . Apparatus as in claim 31 , wherein the flow resisting means comprises a membrane with at least one aperture.
Claim 41
Dependent Claim
62 words
39 . Apparatus as in claim 31 , wherein the flow resisting means comprises a ball valve for partially blocking flow of fluid through the at least one lumen, the ball valve having at least one channel, a ball, and a widened area within the channel into which the ball may be displaced to allow passage of a guidewire through the channel.
Claim 42
Dependent Claim
70 words
40 . Apparatus as in claim 31 , wherein the flow resisting means comprises a compliant membrane coupled to the at least one lumen, the compliant membrane communicating with an inflation lumen, the inflation lumen communicating with an inflation port, wherein inflation via the inflation port and inflation lumen moves the compliant membrane to partially or wholly block fluid flow through the at least one lumen of the catheter body.
Claim 43
Dependent Claim
23 words
41 . Apparatus as in claim 31 , wherein the agent distributing means comprises a porous sheath disposed over the mechanical agitating means.
Claim 44
Dependent Claim
26 words
42 . Apparatus as in claim 41 , wherein the porous sheath is flexible and wherein the mechanical agitating means presses the sheath into the clot.
Claim 45
Dependent Claim
34 words
43 . Apparatus as in claim 31 , further comprising means for isolating at least one location on the catheter body to reduce blood flow through a region in a blood vessel being treated.
Claim 46
Dependent Claim
26 words
44 . Apparatus as in claim 43 , wherein the isolating means isolates both a proximal end and the distal end of the region being treated.
Claim 47
Dependent Claim
23 words
45 . Apparatus as in claim 44 , wherein the isolating means comprised a pair of axially spaced-apart balloons on the catheter body.
Claim 48
Dependent Claim
23 words
46 . Apparatus as in claim 31 , further comprising means for aspirating disrupted clot from a region around the mechanical agitation means.
Claim 49
Dependent Claim
78 words
47 . A method for disrupting clot over a luminal length of a blood vessel, said method comprising: positioning a catheter body at a location within the luminal length of the blood vessel, the catheter body having at least one lumen having a distal-end opening and at least one side opening; and infusing an agent through the distal-end opening and the at least one side opening, wherein the infusing occurs predominantly through the at least one side opening.
Claim 50
Dependent Claim
78 words
47 . A method for disrupting clot over a luminal length of a blood vessel, said method comprising: positioning a catheter body at a location within the luminal length of the blood vessel, the catheter body having at least one lumen having a distal-end opening and at least one side opening; and infusing an agent through the distal-end opening and the at least one side opening, wherein the infusing occurs predominantly through the at least one side opening.
Claim 51
Dependent Claim
22 words
48 . A method as in claim 47 , wherein positioning the catheter body includes passing the catheter body over a guidewire.
Claim 52
Dependent Claim
24 words
49 . A method as in claim 50 , wherein infusing the agent is performed with the catheter body remaining positioned over the guidewire.
Claim 53
Dependent Claim
18 words
50 . A method as in claim 47 , further comprising agitating the clot over the luminal length.
Claim 54
Dependent Claim
18 words
51 . A method as in claim 50 , wherein agitating the clot comprises mechanically agitating the clot.
Claim 55
Dependent Claim
23 words
52 . A method as in claim 50 , wherein agitating the clot comprises agitating the clot at a frequency of 0-20,000 Hertz.
Claim 56
Dependent Claim
30 words
53 . A method as in claim 50 , wherein agitating the clot comprises rotating and/or axially translating a radially expansible agitator within the blood vessel and against the clot.
Claim 57
Dependent Claim
38 words
54 . A method as in claim 53 , wherein the radially expansible agitator is resilient and radially constrained by the blood vessel so that the agitator presses against the clot as it is rotated and/or axially translated.
Claim 58
Dependent Claim
42 words
55 . A method as in claim 53 , wherein infusing the agent comprises delivering the agent through a porous sheath disposed over the agitator, wherein the agent is delivered to the clot while it is being mechanically disrupted by the agitator.
Claim 59
Dependent Claim
59 words
56 . A method as in claim 53 , wherein the agitator comprises a resilient tube which has a non-linear geometry when expanded against the clot, wherein infusing the agent comprises delivering the agent through a lumen of the tube to ports or porous regions distributed over the length of the tube which is in contact with the clot.
Claim 60
Dependent Claim
18 words
57 . A method as in claim 47 , wherein the luminal length is at least 3 cm.
Claim 61
Dependent Claim
16 words
58 . A method as in claim 47 , wherein the blood vessel is a vein.
Claim 62
Dependent Claim
38 words
59 . A method as in claim 58 , wherein the vein is selected from the group consisting of vena cava, iliac vein, femoral vein, popliteal vein, common iliac vein, external iliac vein, brachial vein, and subclavian vein.
Claim 63
Dependent Claim
16 words
60 . A method as in claim 47 , wherein the blood vessel is an artery.
Claim 64
Dependent Claim
37 words
61 . A method as in claim 60 , wherein the artery is selected from the group consisting of the internal iliac artery, external iliac artery, popliteal artery, coronary arteries, superficial femoral artery, and the brachial artery.
Claim 65
Dependent Claim
18 words
62 . A method as in claim 47 , wherein the blood vessel comprises one or more grafts.
Claim 66
Dependent Claim
40 words
63 . A method as in claim 47 , wherein infusing predominantly through the at least one side opening comprises partially blocking flow of the agent through the at least one lumen distal to the at least one side opening.
Claim 67
Dependent Claim
24 words
64 . A method as in claim 47 , further comprising isolating at least one end of the luminal length of the blood vessel.
Claim 68
Dependent Claim
24 words
65 . A method as in claim 64 , further comprising isolating both a proximal end and a distal end of the luminal length.
Claim 69
Dependent Claim
18 words
66 . A method as in claim 64 , wherein isolating comprises inflating at least one occlusion balloon.
Claim 70
Dependent Claim
18 words
67 . A method as in claim 64 , wherein isolating is performed prior to infusing the agent.
Claim 71
Dependent Claim
20 words
68 . A method as in claim 67 , wherein isolating is maintained until after infusing the agent has stopped.
Claim 72
Dependent Claim
24 words
69 . A method as in claim 47 , further comprising aspirating disrupted clot material from along the luminal length of the blood vessel.
Claim 73
Dependent Claim
23 words
70 . A method as in claim 69 , wherein aspirating disrupted clot and infusing the agent are performed through a common lumen.
Claim 74
Dependent Claim
35 words
71 . A method as in claim 69 , wherein the at least one lumen comprises two lumens, aspirating clot being performed through one lumen and infusing the agent being performed through the other lumen.
Claim 75
Dependent Claim
39 words
72 . A method as in claim 69 , wherein the clot material is agitated by an agitator supported by the catheter body, and wherein the disrupted clot material is aspirated through an aspiration lumen within the catheter body.
Claim 76
Dependent Claim
24 words
73 . A method as in claim 72 , wherein the disrupted clot material is aspirated using a pump disposed within the aspiration lumen.
Claim 77
Dependent Claim
39 words
74 . A method as in claim 69 , wherein the clot material is agitated by an agitator supported by the catheter body, and wherein the disrupted clot material is aspirated through an aspiration lumen of an aspiration catheter.
Claim 78
Dependent Claim
26 words
75 . A method as in claim 69 , further comprising providing reduced aspiration of fluid through the distal-end opening of the at least one lumen.
Claim 79
Dependent Claim
28 words
76 . A method as in claim 75 , wherein providing reduced aspiration comprises resisting fluid flow through the at least one lumen proximal to the distal-end opening.
Claim 80
Dependent Claim
55 words
77 . A method for disrupting clot over a luminal length within a blood vessel, said method comprising: isolating the luminal length from blood flow; infusing an agent along the luminal length; providing reduced infusion of the agent at a location distal to the luminal length; and mechanically agitating the clot along the luminal length.
Claim 81
Dependent Claim
55 words
77 . A method for disrupting clot over a luminal length within a blood vessel, said method comprising: isolating the luminal length from blood flow; infusing an agent along the luminal length; providing reduced infusion of the agent at a location distal to the luminal length; and mechanically agitating the clot along the luminal length.
Claim 82
Dependent Claim
28 words
78 . A kit comprising: a catheter having an agitator and a thrombolytic agent delivery means; and instructions for use according to the method of claim 47 .
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