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US6544276B1 Expired / Lapsed US ⏱️ 0.0 years remaining

Exchange method for emboli containment

Assignee: Kardiametrix LLC
•
Filing: 1998-03-27
•
Granted: 2003-04-08
•
Expires: 2018-03-27
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Abstract

Abstract The present invention provides a method for exchanging catheters while containing emboli within a blood vessel such as a saphenous vein graft, coronary artery, carotid artery, or other similar vessels. A guidewire is inserted through the vasculature of a patient until it reaches a desired treatment site. A therapy catheter is then inserted over the guidewire until the distal end of the therapy catheter reaches the treatment site. The guidewire has a distally mounted balloon which is inflated to occlude the blood vessel. Then, the therapy catheter provides means for treating the vessel at the treatment site. After treatment, the therapy catheter is removed from the guidewire and exchanged with an aspiration catheter which rides over the guidewire until the distal end of the aspiration catheter reaches the treatment site. The aspiration catheter applies negative pressure to remove any emboli formed by the treatment procedure.

Inventors

  • 👤 Gholam-Reza Zadno Azizi

Bibliographic Details

Application Number —
Jurisdiction US
Data Source google_patents
Last Synchronized 2026-10-22 23:23
CPC Classifications
A; A61; A61M; A61M25/00; A61M25/10; A61M25/1018; A61M25/10184; A61F; A61F2/00; A61F2/01; A61F2/0108; A61B; A61B17/00; A61B17/12; A61B17/12022; A61B17/12027; A61B17/12036; A61B17/12099; A61B17/12109; A61B17/12113; A61B17/12131; A61B17/12136; A61B17/12168; A61B17/12172; A61B17/12181; A61B17/12186; A61B17/22; A61F2/013; A61M25/0009; A61M25/0043; A61M25/0054; A61M25/0067; A61M25/0074; A61M25/0075; A61M25/01; A61M25/09; A61M25/09016; A61M25/09033; A61M25/1011; A61M25/1027; A61M25/104; A61B2017/22051; A61B2017/22065; A61B2017/22067; A61B17/32; A61B17/3205; A61B17/3207; A61B2017/320716; A61F2/011; A61F2230/00; A61F2230/0002; A61F2230/0004; A61F2230/0006; A61M2025/0018; A61M2025/09008; A61M2025/09116; A61M2025/09125; A61M2025/09175; A61M2025/1015; A61M2025/1043; A61M2025/1052; A61M2025/1079; A61M2025/1081; A61M2025/1093; A61M25/0021; A61M25/0023; A61M25/0026; A61M25/005; A61M25/10185

Claims Analysis

Total Claims: 50
Claim 1
Independent Claim 342 words
A method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising the steps of: (a) delivering a guidewire having a proximal end and a distal end into the vasculature of a patient until the distal end is near to a treatment site in the blood vessel, the distal end of the guidewire having an occlusive device thereon, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of the blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel; (b) delivering a first therapy catheter comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the first therapy catheter is near to the treatment site; (c) performing a first therapy treatment which results in the presence of emboli in the blood vessel at the treatment site; (d) removing the first therapy catheter from the guidewire; (e) delivering a second therapy catheter comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the second therapy catheter is near to the treatment site; (f) performing a second therapy treatment which results in the presence of emboli in the blood vessel at the treatment site; (g) removing the second therapy catheter from the guidewire; (h) delivering an emboli removal device comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the emboli removal device is near to the treatment site; and (i) removing emboli from the blood vessel through a lumen of the emboli removal device; wherein the occlusive device is in its expanded state distal to the treatment site continuously at least from step (c) to step (i) to isolate the emboli at the treatment site.
Claim 2
Independent Claim 342 words
A method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising the steps of: (a) delivering a guidewire having a proximal end and a distal end into the vasculature of a patient until the distal end is near to a treatment site in the blood vessel, the distal end of the guidewire having an occlusive device thereon, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of the blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel; (b) delivering a first therapy catheter comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the first therapy catheter is near to the treatment site; (c) performing a first therapy treatment which results in the presence of emboli in the blood vessel at the treatment site; (d) removing the first therapy catheter from the guidewire; (e) delivering a second therapy catheter comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the second therapy catheter is near to the treatment site; (f) performing a second therapy treatment which results in the presence of emboli in the blood vessel at the treatment site; (g) removing the second therapy catheter from the guidewire; (h) delivering an emboli removal device comprising an elongate catheter shaft having a proximal end, a distal end, and at least one lumen, over the guidewire until the distal end of the emboli removal device is near to the treatment site; and (i) removing emboli from the blood vessel through a lumen of the emboli removal device; wherein the occlusive device is in its expanded state distal to the treatment site continuously at least from step (c) to step (i) to isolate the emboli at the treatment site.
Claim 3
Dependent Claim 14 words
The method of claim 1 , wherein the occlusive device is an inflatable balloon.
Claim 4
Dependent Claim 14 words
The method of claim 1 , wherein the occlusive device is a self-expanding member.
Claim 5
Dependent Claim 15 words
The method of claim 1 , wherein the occlusive device is a mechanically deployed member.
Claim 6
Dependent Claim 17 words
The method of claim 1 , wherein the first therapy catheter is delivered independently of the guidewire.
Claim 7
Dependent Claim 17 words
The method of claim 1 , wherein the first therapy catheter is delivered simultaneously with the guidewire.
Claim 8
Dependent Claim 22 words
The method of claim 1 , wherein the first therapy catheter is delivered while the occlusive device is in its nonexpanded state.
Claim 9
Dependent Claim 35 words
The method of claim 1 , wherein the first therapy catheter has a dilatation balloon with a first diameter mounted on its distal end for compressing plaque found on the walls of the blood vessel.
Claim 10
Dependent Claim 40 words
The method of claim 8 , wherein the second therapy catheter has a dilatation balloon with a second diameter larger than the first diameter mounted on its distal end for compressing plaque found on the walls of the blood vessel.
Claim 11
Dependent Claim 15 words
The method of claim 1 , wherein the emboli removal device is an aspiration catheter.
Claim 12
Independent Claim 290 words
A method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising the steps of: (a) delivering a guidewire having a proximal end and a distal end into the vasculature of a patient until the distal end is near to a treatment site in the blood vessel, the distal end of the guidewire having an occlusive device thereon, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of the blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel; (b) delivering a therapy catheter comprising an elongate catheter shaft having a proximal end and a distal end into the vasculature until the distal end of the therapy catheter is near to the treatment site; (c) actuating the occlusive device at a location distal to the treatment site from its nonexpanded state to its expanded state; (d) performing treatment on the treatment site with the therapy catheter, said treatment resulting in emboli in the vessel proximal to the actuated occlusive device; (e) removing the therapy catheter from the vasculature and from the guidewire; (f) delivering an emboli removal device having a proximal end and a distal end into the vasculature until the distal end of the emboli removal device is near to the treatment site and proximal to the occlusive device; (g) removing emboli from the treatment site with the emboli removal device; and (h) de-actuating the occlusive device; wherein the occlusive device is maintained in its expanded state continuously from step (c) through step (g) to isolate emboli to the treatment site proximal to the occlusive device.
Claim 13
Independent Claim 290 words
A method of performing treatment in a blood vessel while isolating emboli to a portion of the blood vessel, the method comprising the steps of: (a) delivering a guidewire having a proximal end and a distal end into the vasculature of a patient until the distal end is near to a treatment site in the blood vessel, the distal end of the guidewire having an occlusive device thereon, the occlusive device being actuatable between an expanded state in which the occlusive device engages at least a portion of the walls of the blood vessel, and a nonexpanded state in which the occlusive device does not engage the walls of the blood vessel; (b) delivering a therapy catheter comprising an elongate catheter shaft having a proximal end and a distal end into the vasculature until the distal end of the therapy catheter is near to the treatment site; (c) actuating the occlusive device at a location distal to the treatment site from its nonexpanded state to its expanded state; (d) performing treatment on the treatment site with the therapy catheter, said treatment resulting in emboli in the vessel proximal to the actuated occlusive device; (e) removing the therapy catheter from the vasculature and from the guidewire; (f) delivering an emboli removal device having a proximal end and a distal end into the vasculature until the distal end of the emboli removal device is near to the treatment site and proximal to the occlusive device; (g) removing emboli from the treatment site with the emboli removal device; and (h) de-actuating the occlusive device; wherein the occlusive device is maintained in its expanded state continuously from step (c) through step (g) to isolate emboli to the treatment site proximal to the occlusive device.
Claim 14
Dependent Claim 14 words
The method of claim 11 , wherein the occlusive device is an inflatable balloon.
Claim 15
Dependent Claim 14 words
The method of claim 11 , wherein the occlusive device is a self-expanding member.
Claim 16
Dependent Claim 15 words
The method of claim 11 , wherein the occlusive device is a mechanically deployed member.
Claim 17
Dependent Claim 16 words
The method of claim 11 , wherein the therapy catheter is delivered independently of the guidewire.
Claim 18
Dependent Claim 16 words
The method of claim 11 , wherein the therapy catheter is delivered simultaneously with the guidewire.
Claim 19
Dependent Claim 21 words
The method of claim 11 , wherein the therapy catheter is delivered while the occlusive device is in its nonexpanded state.
Claim 20
Dependent Claim 14 words
The method of claim 11 , wherein the therapy catheter is a dilatation catheter.
Claim 21
Dependent Claim 41 words
The method of claim 11 , wherein the therapy catheter performs treatment selected from the group consisting of stent delivery, drug delivery, atherectomy, shock wave generation, laser ablation, ultrasound ablation, vibration delivery and embolization element delivery for treatment of an aneurysm.
Claim 22
Dependent Claim 20 words
The method of claim 11 , wherein the therapy catheter includes a lumen which is sized to override the guidewire.
Claim 23
Dependent Claim 15 words
The method of claim 11 , wherein the emboli removal device is an aspiration catheter.
Claim 24
Dependent Claim 15 words
The method of claim 21 , wherein the aspiration catheter is delivered over the guidewire.
Claim 25
Dependent Claim 89 words
The method of claim 11 , further comprising, between steps (e) and (f), the steps of: (i) delivering a second therapy catheter comprising an elongate catheter shaft having a proximal end and a distal end into the vasculature until the distal end of the second therapy catheter is near to the treatment site; (j) performing treatment on the treatment site with the second therapy catheter, said treatment resulting in emboli in the vessel proximal to the actuated occlusive device; and (k) removing the second therapy catheter from the vasculature.
Claim 26
Independent Claim 211 words
A method for exchanging catheters while isolating emboli to a working area in a blood vessel, comprising: delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon; delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area; actuating the occlusive device at a location distal to the desired working area such that the device at least partially obstructs blood flow through the vessel; performing treatment in the working area with the first catheter while continuously maintaining actuation of the occlusive device, said treatment resulting in emboli within the working area isolated proximal to the occlusive device; removing the first catheter from the guidewire while continuously maintaining actuation of the occlusive device; delivering an aspiration catheter having a proximal and a distal end over the guidewire while continuously maintaining actuation of the occlusive device such that the distal end of the aspiration catheter is located within the working area; and applying negative pressure to the aspiration catheter to remove emboli isolated within the working area.
Claim 27
Independent Claim 211 words
A method for exchanging catheters while isolating emboli to a working area in a blood vessel, comprising: delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon; delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area; actuating the occlusive device at a location distal to the desired working area such that the device at least partially obstructs blood flow through the vessel; performing treatment in the working area with the first catheter while continuously maintaining actuation of the occlusive device, said treatment resulting in emboli within the working area isolated proximal to the occlusive device; removing the first catheter from the guidewire while continuously maintaining actuation of the occlusive device; delivering an aspiration catheter having a proximal and a distal end over the guidewire while continuously maintaining actuation of the occlusive device such that the distal end of the aspiration catheter is located within the working area; and applying negative pressure to the aspiration catheter to remove emboli isolated within the working area.
Claim 28
Dependent Claim 16 words
The method of claim 24 , wherein the first catheter is delivered independently of the guidewire.
Claim 29
Dependent Claim 16 words
The method of claim 24 , wherein the first catheter is delivered simultaneously with the guidewire.
Claim 30
Dependent Claim 18 words
The method of claim 24 , wherein the first catheter is delivered prior to actuating the occlusive device.
Claim 31
Dependent Claim 15 words
The method of claim 24 , further comprising removing the aspiration catheter from the guidewire.
Claim 32
Dependent Claim 18 words
The method of claim 28 , further comprising de-actuating the occlusive device prior to removing the aspiration catheter.
Claim 33
Dependent Claim 24 words
The method of claim 28 , further comprising delivering a second catheter over the guidewire and performing a second treatment to the blood vessel.
Claim 34
Dependent Claim 32 words
The method of claim 30 , further comprising re-actuating the occlusive device after delivering the second catheter over the guidewire and continuously maintaining actuation of the occlusive device during said second treatment.
Claim 35
Independent Claim 171 words
A method for exchanging catheters, comprising: delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon; delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area; expanding the occlusive device at a location distal to the desired working area such that the device at least partially obstructs blood flow through the vessel; performing treatment in the working area with the first catheter while continuously maintaining the occlusive device in its expanded state, said treatment resulting in emboli within the working area; removing the first catheter from the guidewire while continuously maintaining the occlusive device in its expanded state; delivering an emboli removal device over the guidewire while continuously maintaining the occlusive device in its expanded state; and removing said emboli from the working area.
Claim 36
Independent Claim 171 words
A method for exchanging catheters, comprising: delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon; delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area; expanding the occlusive device at a location distal to the desired working area such that the device at least partially obstructs blood flow through the vessel; performing treatment in the working area with the first catheter while continuously maintaining the occlusive device in its expanded state, said treatment resulting in emboli within the working area; removing the first catheter from the guidewire while continuously maintaining the occlusive device in its expanded state; delivering an emboli removal device over the guidewire while continuously maintaining the occlusive device in its expanded state; and removing said emboli from the working area.
Claim 37
Independent Claim 184 words
A method for exchanging catheters in a blood vessel, comprising: delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon; actuating the occlusive device at a location distal to the desired working area such that the occlusive device inhibits emboli from moving past the occlusive device; delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area; performing a first treatment in the working area with the first catheter while the occlusive device is actuated to inhibit emboli from moving past the occlusive device; removing the first catheter from the guidewire while the occlusive device is actuated; delivering a second catheter :over the guidewire while the occlusive device is actuated; and performing a second treatment in the working area with the second catheter while the occlusive device is actuated to inhibit emboli from moving past the occlusive device.
Claim 38
Independent Claim 184 words
A method for exchanging catheters in a blood vessel, comprising: delivering a guidewire having a proximal end and a distal end into the blood vessel until the distal end of the guidewire is near to a desired working area, the distal end having an occlusive device thereon; actuating the occlusive device at a location distal to the desired working area such that the occlusive device inhibits emboli from moving past the occlusive device; delivering a first catheter having a proximal end and a distal end over the guidewire until the distal end of the first catheter is near to the desired working area; performing a first treatment in the working area with the first catheter while the occlusive device is actuated to inhibit emboli from moving past the occlusive device; removing the first catheter from the guidewire while the occlusive device is actuated; delivering a second catheter :over the guidewire while the occlusive device is actuated; and performing a second treatment in the working area with the second catheter while the occlusive device is actuated to inhibit emboli from moving past the occlusive device.
Claim 39
Dependent Claim 22 words
The method of claim 33 , wherein the treatment performed by one of the first catheter and the second catheter is aspiration.
Claim 40
Dependent Claim 19 words
The method of claim 33 , wherein one of the first catheter and the second catheter deploys a stent.
Claim 41
Dependent Claim 21 words
The method of claim 35 , wherein the other of the first catheter and the second catheter is an infusion catheter.
Claim 42
Dependent Claim 16 words
The method of claim 36 , further comprising aspirating the working area to extract debris therefrom.
Claim 43
Dependent Claim 20 words
The method of claim 33 , wherein one of the first catheter and the second catheter is an infusion catheter.
Claim 44
Dependent Claim 21 words
The method of claim 33 , wherein one of the first catheter and the second catheter is a dilatation balloon catheter.
Claim 45
Dependent Claim 20 words
The method of claim 33 , wherein the actuating of the occlusive device is performed after delivering the first catheter.
Claim 46
Dependent Claim 11 words
The method of claim 33 , wherein the guidewire is hollow.
Claim 47
Dependent Claim 13 words
The method of claim 41 , wherein the occlusive device is a balloon.
Claim 48
Dependent Claim 13 words
The method of claim 33 , wherein the occlusive device is a filter.
Claim 49
Dependent Claim 11 words
The method of claim 43 , wherein the filter is self-actuating.
Claim 50
Dependent Claim 11 words
The method of claim 43 , wherein the filter is mechanically-deployed.

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