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US20030139751A1 Expired / Lapsed US ⏱️ 0.0 years remaining

Apparatus and methods for clot dissolution

Assignee: Covidien LP
•
Filing: 2002-10-21
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Granted: —
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Expires: 2022-10-21
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Abstract

Abstract Clot disruption and dissolution are achieved using a catheter having the ability to infuse a thrombolytic agent, agitate the clot and agent, and aspirate broken-up clot from the blood vessel. 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
  • 👤 Jody Cimbalo
  • 👤 Stephen Leeflang

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 22:27
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/32; A61B17/3205; A61B17/3207; A61B17/320758; A61B17/22; A61M; A61M25/00; A61M25/0021; A61P; A61P9/00; A61B17/22004; A61B2017/00681; A61B2017/00685; A61B2017/22051; A61B2017/22054; A61B2017/22065; A61B2017/22067; A61B2017/22082; A61B2017/22084; A61B2017/320716; A61B2017/320766; A61M25/10; A61M2025/1043; A61M2025/1052; A61M25/0067; A61M25/0068; A61M25/007; A61M25/0074; A61M25/0075; A61M25/01; A61M25/0105; A61M39/00; A61M39/22

Claims Analysis

Total Claims: 57
Claim 1
Independent Claim 80 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, at least one lumen extending between said ends, a distal opening, and at least one side opening proximal to the distal-end opening; a first radially expandable occlusion body on the catheter body between the distal-end opening and the at least one side opening; and an agitator removable insertable into the catheter body lumen.
Claim 2
Dependent Claim 80 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, at least one lumen extending between said ends, a distal opening, and at least one side opening proximal to the distal-end opening; a first radially expandable occlusion body on the catheter body between the distal-end opening and the at least one side opening; and an agitator removable insertable into the catheter body lumen.
Claim 3
Dependent Claim 34 words
2 . Apparatus as in claim 1 , wherein the distal-end opening is configured to inhibit flow therethrough to preferential cause flow from the lumen to pass through the at least one side opening.
Claim 4
Dependent Claim 34 words
3 . Apparatus as in claim 2 , 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 5
Dependent Claim 46 words
4 . Apparatus as in claim 3 , 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 6
Dependent Claim 21 words
5 . Apparatus as in claim 3 , wherein the flow resistor comprises a cylindrical material having at least one channel.
Claim 7
Dependent Claim 16 words
6 . Apparatus as in claim 5 , wherein the cylindrical material comprises an elastomeric material.
Claim 8
Dependent Claim 28 words
7 . Apparatus as in claim 5 , wherein the outer diameter of the cylindrical material is equal to the inner diameter of the at least one lumen.
Claim 9
Dependent Claim 29 words
8 . Apparatus as in claim 5 , wherein the at least one channel comprises a cylindrical hole having an inner diameter sufficient to allow passage of the guidewire.
Claim 10
Dependent Claim 20 words
9 . Apparatus as in claim 5 , wherein the at least one channel comprises one or more flexible slits.
Claim 11
Dependent Claim 33 words
10 . Apparatus as in claim 5 , 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 12
Dependent Claim 20 words
11 . Apparatus as in claim 3 , wherein the flow resistor comprises a membrane with at least one aperture.
Claim 13
Dependent Claim 26 words
12 . Apparatus as in claim 11 , wherein the membrane is crowned with a concave surface facing toward the proximal end of the catheter body.
Claim 14
Dependent Claim 19 words
13 . Apparatus as in claim 12 , wherein the aperture has a cross-sectional area up to 1 mm.
Claim 15
Dependent Claim 15 words
14 . Apparatus as in claim 13 , wherein the aperture has an oval periphery.
Claim 16
Dependent Claim 61 words
15 . Apparatus as in claim 3 , 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 17
Dependent Claim 69 words
16 . Apparatus as in claim 3 , 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 18
Dependent Claim 34 words
17 . 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 19
Dependent Claim 28 words
18 . Apparatus as in claim 1 , wherein the at least one side opening consists of a single opening in a side wall of the catheter body.
Claim 20
Dependent Claim 38 words
19 . Apparatus as in claim 18 , wherein the single opening has a minimum width which is equal to at least 50% of the outer diameter of the catheter body at the location of the single opening.
Claim 21
Dependent Claim 24 words
20 . Apparatus as in claim 19 , further comprising a reinforcement sleeve over the catheter body at the location of the single opening.
Claim 22
Dependent Claim 29 words
21 . Apparatus as in claim 2 , wherein the at least one side opening comprises a plurality of spaced-apart openings in a side wall of the catheter body.
Claim 23
Dependent Claim 30 words
22 . 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 24
Dependent Claim 15 words
23 . Apparatus as in claim 22 , wherein the agitator comprises a mechanical agitator.
Claim 25
Dependent Claim 22 words
24 . Apparatus as in claim 23 , further comprising a driver which moves the agitator at a frequency of 1-20,000 Hertz.
Claim 26
Dependent Claim 18 words
25 . Apparatus as in claim 23 , wherein the driver rotates the agitator within the catheter body.
Claim 27
Dependent Claim 19 words
26 . Apparatus as in claim 23 , wherein the driver axially translates the agitator within the catheter body.
Claim 28
Dependent Claim 24 words
27 . Apparatus as in claim 23 , wherein the agitator assumes a non-linear geometry when inserted into the lumen of the catheter body.
Claim 29
Dependent Claim 25 words
28 . Apparatus as in claim 27 , further comprising a driver which rotates the agitator at a frequency from 1 Hz to 50 Hz.
Claim 30
Dependent Claim 22 words
29 . Apparatus as in claim 28 , wherein the driver allows manual axial translation of the driver within the catheter body.
Claim 31
Dependent Claim 28 words
30 . Apparatus as in claim 27 , wherein the a non-linear geometry is selected from the group consisting of helical, spiral, serpentine, zig-zag, alternating helical, and random.
Claim 32
Dependent Claim 18 words
31 . Apparatus as in claim 1 , wherein the first radially expandable occlusion body comprises a balloon.
Claim 33
Dependent Claim 24 words
32 . Apparatus as in claim 1 , further comprising a second radially expandable occlusion body proximal to the at least one side opening.
Claim 34
Dependent Claim 31 words
33 . Apparatus as in claim 32 , wherein the first and second radially expandable bodies are axially spaced-apart by a distance in the range from 5 cm to 50 cm.
Claim 35
Dependent Claim 28 words
34 . Apparatus as in claim 33 , wherein the catheter body has first and second inflation lumens connected to the first and second radially expandable bodies, respectively.
Claim 36
Dependent Claim 76 words
35 . A method for disrupting clot over a luminal length of a blood vessel, said method comprising: positioning a catheter body within the luminal length of the blood vessel; infusing a thrombolytic agent through a lumen of the catheter body into the luminal length of the blood vessel; and eccentrically rotating at least a portion of the catheter body within the luminal length of the blood vessel to agitate the thrombolytic agent within the clot.
Claim 37
Dependent Claim 76 words
35 . A method for disrupting clot over a luminal length of a blood vessel, said method comprising: positioning a catheter body within the luminal length of the blood vessel; infusing a thrombolytic agent through a lumen of the catheter body into the luminal length of the blood vessel; and eccentrically rotating at least a portion of the catheter body within the luminal length of the blood vessel to agitate the thrombolytic agent within the clot.
Claim 38
Dependent Claim 22 words
36 . A method as in claim 35 , wherein positioning the catheter body includes passing the catheter body over a guidewire.
Claim 39
Dependent Claim 25 words
37 . A method as in claim 35 , wherein infusing the thrombolytic agent is performed with the catheter body remaining positioned over the guidewire.
Claim 40
Dependent Claim 20 words
38 . A method as in claim 35 , wherein the catheter is rotated at a frequency of 1-20,000 Hertz.
Claim 41
Dependent Claim 31 words
39 . A method as in claim 35 , wherein rotating the catheter body comprises a radially expandable agitator within the catheter body to sweep the catheter body against the clot.
Claim 42
Dependent Claim 32 words
40 . A method as in claim 39 , wherein the radially expandable agitator is resilient and radially self-expanding so that it is constrained by the blood vessel as it is rotated.
Claim 43
Dependent Claim 21 words
41 . A method as in claim 40 , wherein the agitator has a non-linear geometry when expanded against the clot.
Claim 44
Dependent Claim 18 words
42 . A method as in claim 35 , wherein the luminal length is at least 3 cm.
Claim 45
Dependent Claim 16 words
43 . A method as in claim 35 , wherein the blood vessel is a vein.
Claim 46
Dependent Claim 38 words
44 . A method as in claim 43 , 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 47
Dependent Claim 16 words
45 . A method as in claim 35 , wherein the blood vessel is an artery.
Claim 48
Dependent Claim 37 words
46 . A method as in claim 45 , 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 49
Dependent Claim 18 words
47 . A method as in claim 35 , wherein the blood vessel comprises one or more grafts.
Claim 50
Dependent Claim 24 words
48 . A method as in claim 35 , further comprising isolating at least one end of the luminal length of the blood vessel.
Claim 51
Dependent Claim 24 words
49 . A method as in claim 48 , further comprising isolating both a proximal end and a distal end of the luminal length.
Claim 52
Dependent Claim 18 words
50 . A method as in claim 48 , wherein isolating comprises inflating at least one occlusion balloon.
Claim 53
Dependent Claim 23 words
51 . A method as in claim 48 , wherein isolating at least a distal end is performed prior to infusing the agent.
Claim 54
Dependent Claim 23 words
52 . A method as in claim 51 , wherein isolating at least one distal end is maintained until after agitating has stopped.
Claim 55
Dependent Claim 24 words
53 . A method as in claim 35 , further comprising aspirating disrupted clot material from along the luminal length of the blood vessel.
Claim 56
Dependent Claim 27 words
54 . A method as in claim 53 , wherein aspirating disrupted clot and infusing the agent are performed through a common lumen in the catheter body.
Claim 57
Dependent Claim 27 words
55 . A kit comprising: a catheter having an agitator and a thrombolytic agent delivery means; and instructions for use according to the method of claim 35.

References Cited (Backward Citations)

US5596005A Cited
US6156048A Cited
US6454775B1 Cited

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