WO2003082377A1 - Valve d'aspiration pour catheter - Google Patents

Valve d'aspiration pour catheter Download PDF

Info

Publication number
WO2003082377A1
WO2003082377A1 PCT/US2003/009514 US0309514W WO03082377A1 WO 2003082377 A1 WO2003082377 A1 WO 2003082377A1 US 0309514 W US0309514 W US 0309514W WO 03082377 A1 WO03082377 A1 WO 03082377A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
aspiration
suction
catheter
inlet
Prior art date
Application number
PCT/US2003/009514
Other languages
English (en)
Inventor
Michael Hogendijk
Original Assignee
Arteria Medical Science, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US10/112,807 external-priority patent/US6960189B2/en
Priority claimed from US10/138,013 external-priority patent/US7033336B2/en
Application filed by Arteria Medical Science, Inc. filed Critical Arteria Medical Science, Inc.
Priority to AU2003218438A priority Critical patent/AU2003218438A1/en
Publication of WO2003082377A1 publication Critical patent/WO2003082377A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A61M1/741—Suction control with means for varying suction manually
    • A61M1/7413—Suction control with means for varying suction manually by changing the cross-section of the line
    • A61M1/7415—Suction control with means for varying suction manually by changing the cross-section of the line by deformation of the fluid passage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/71—Suction drainage systems
    • A61M1/74—Suction control
    • A61M1/741—Suction control with means for varying suction manually
    • A61M1/7413—Suction control with means for varying suction manually by changing the cross-section of the line
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0074—Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
    • A61M25/0075—Valve means
    • A61M2025/0076—Unidirectional valves
    • A61M2025/0078—Unidirectional valves for fluid inflow from the body into the catheter lumen

Definitions

  • the present invention relates to an improved proximal catheter assembly, and more specifically, a catheter handle that is configured to provide a lumen of a catheter with substantially continuous natural aspiration and, optionally, suction-assisted aspiration that may be regulated using a self-limiting valve.
  • proximal catheter assembly that provides an appropriate level of retrograde flow at a treatment site to direct dislodged particles into a catheter for efficient removal without damaging the treatment vessel .
  • proximal catheter assembly that provides an external suction/infusion port that selectively may be used, in conjunction with natural aspiration techniques, to further influence flow in a treatment vessel .
  • proximal catheter assembly that is configured to minimize "back-bleed” that occurs when flow exits through a hemostatic port disposed at the proximal end of a catheter.
  • proximal catheter assembly having a check valve functionality to selectively enable the provision of either natural or suction assisted aspiration through a working lumen of a catheter.
  • a proximal catheter assembly that allows a catheter to achieve a substantially continuous rate of natural, physiologically-regulated aspiration through a working lumen of the catheter.
  • a proximal catheter assembly that provides an appropriate rate of retrograde flow at a treatment site to direct dislodged particles into a catheter for efficient removal, without damaging the treatment vessel.
  • a proximal catheter assembly that provides an external suction/infusion port that selectively may be used, in conjunction with natural aspiration techniques, to further influence flow in a treatment vessel.
  • a proximal catheter assembly that allows emboli to be filtered and blood reperfused into a patient's vessel to reduce blood loss.
  • a proximal catheter assembly having a relief valve functionality to regulate the rate of suction-assisted aspiration that may be provided through the working lumen of the catheter.
  • a proximal catheter assembly that is configured to enable two types of aspiration through a catheter lumen.
  • the proximal catheter assembly enables a substantially continuous rate of natural, physiologically-regulated aspiration through the catheter lumen using an arterial -venous shunt and, optionally, suction-assisted aspiration through the catheter lumen.
  • suction/infusion port may be used to selectively provide an antegrade flow, e.g., of a therapeutic drug or lytic agent .
  • a proximal catheter assembly of the device of the present invention comprises a handle that is coupled to a catheter, so that a working lumen of the catheter is in fluid communication with a bore of the handle.
  • the handle preferably comprises an external suction/infusion port and at least one hemostatic port, each of which are in fluid communication with the working lumen of the catheter.
  • the handle also is coupled to a blood outlet port that is in fluid communication with the working lumen, and preferably further comprises an inflation port that is in fluid communication with an inflation lumen of the catheter.
  • the blood outlet port coupled to the handle may be coupled to a venous return line, which is adapted to be disposed in a remote vein.
  • a pressure differential between venous and arterial pressure will cause blood to flow in a retrograde fashion in the artery.
  • blood in the artery flows into the working lumen, through the outlet port, and then through the venous return line, where it then is reperfused into the remote vein.
  • a filter may be disposed between the outlet port and the venous return line to remove any emboli prior to reperfusing blood into the remove vein.
  • This natural, physiologically-regulated aspiration through the outlet port coupled to the catheter handle preferably occurs before, during and after a medical procedure performed through the working lumen of the catheter to effectively remove thrombi and/or emboli from the vessel.
  • Additional suction selectively may be applied by coupling a syringe to the external suction/infusion port, to further influence aspiration of the vessel.
  • the syringe may be used to infuse saline, drugs or other therapeutic agents to the treatment site.
  • the hemostatic port coupled to the handle allows for the delivery of angioplasty, stent delivery systems or other devices to the treatment site.
  • the proximal catheter assembly further comprises a handle having a roller clamp valve.
  • a proximal catheter assembly comprises a check/relief valve configured to perform functions associated with conventional check valves and relief valves.
  • the check valve functionality allows the valve to regulate the direction of fluid flow by selectively enabling either natural or suction assisted aspiration through a working lumen of a catheter.
  • the relief valve functionality allows the valve to regulate the rate of suction-assisted aspiration that may be provided through the working lumen of the catheter.
  • the check/relief valve opens to allow blood to be drawn from tubing coupled to the venous return line.
  • relatively high rates of suction-assisted aspiration will not be imposed upon the working lumen and the patient's vessel, but rather will be mitigated by the check/relief valve.
  • FIG. 1 provides a top sectional view of a proximal catheter assembly in accordance with principles of the present invention
  • FIG. 2 provides a cross-sectional view along line A- -A of FIG. 1
  • FIGS. 3A-3B are, respectively, a top view and a top sectional view of an alternative embodiment of the present invention
  • FIGS. 4A-4C are, respectively, a side view and side sectional views of the proximal catheter assembly of FIGS . 3 ;
  • FIGS. 5A-5C are, respectively, two top views and a cross-sectional view illustrating a proximal catheter assembly having a check/relief valve provided in accordance with principles of the present invention
  • FIGS. 6A-6C illustrate a method of using the check/relief valve of FIGS. 5A-5C;
  • FIGS. 7A-7B are, respectively, top and cross- sectional views illustrating an alternative embodiment of the check/relief valve of FIGS. 5A-6C;
  • FIGS. 8A-8C illustrate a method of using the check/relief valve of FIGS. 7A-7B.
  • the present invention is directed to a proximal catheter assembly that is configured to enable natural aspiration through a catheter lumen and, optionally, suction-assisted aspiration or infusion through the catheter lumen.
  • the proximal catheter assembly of the present invention enables a substantially continuous rate of natural, physiologically-regulated aspiration through the lumen of the catheter by enabling fluid communication between the lumen of the catheter and a patient's venous vasculature.
  • the proximal catheter assembly also provides an external suction/infusion port that may be used in conjunction with a syringe, so that a physician further may influence the rate of aspiration through the lumen of the catheter.
  • the provision of substantially continuous retrograde flow and, optionally, selectively increased rates of retrograde flow at a treatment site facilitates removal of emboli during an interventional procedure while minimizing trauma to the treatment vessel .
  • the proximal catheter assembly preferably is provided with a check/relief valve configured to selectively provide either natural or suction assisted aspiration through the lumen, and further configured to regulate the rate of suction-assisted aspiration that may be provided through the lumen.
  • Proximal catheter assembly 10 is coupled to catheter 41 having proximal and distal ends and working lumen 58 extending therebetween.
  • Proximal catheter assembly 10 comprises handle 12 having proximal and distal ends, and bore 68 extending therebetween.
  • the proximal end of catheter 41 preferably is affixed within bore 68 near distal end 13 of handle 12, so that working lumen 58 of catheter 41 and bore 68 of handle 12 are in fluid communication with each other.
  • Handle 12 comprises external suction/infusion port 14, which is in fluid communication with bore 68 and working lumen 58 of catheter 41. External suction/infusion port 14 is configured to receive syringe 16, which may be used to induce enhanced aspiration or infusion through working lumen 58. [0038] Handle 12 preferably further comprises inflation port 20, which is in fluid communication with inflation lumen 63 of catheter 41. Inflation lumen 63 further is in fluid communication with occlusive element 42, e.g., a balloon that is disposed at the distal end of catheter 41, so that occlusive element 42 may be deployed via inflation port 20 and inflation lumen 63.
  • occlusive element 42 e.g., a balloon that is disposed at the distal end of catheter 41, so that occlusive element 42 may be deployed via inflation port 20 and inflation lumen 63.
  • Handle 12 is coupled to blood outlet port 26, which in turn preferably is coupled to a venous return line (not shown) that is adapted to be inserted into a patient's venous vasculature.
  • one-way check valve 22 may be disposed between handle 12 and blood outlet port 26, as shown in FIG. 1, to ensure that flow through the valve occurs exclusively in the direction indicated. For example, when flow is aspirated through catheter 41 via working lumen 58, that flow may enter and pass through one-way check valve 22, then flow through optional tubing 24 and through blood outlet port 26. However, one-way check valve 22 will not allow flow to occur through the valve in an opposite direction, i.e., from blood outlet port 26 into working lumen 58. For example, one-way check valve 22 may close when suction is being provided via syringe 16 to ensure that flow from blood outlet port 26 does not re-enter bore 68 and/or working lumen 58.
  • Handle 12 of proximal catheter assembly 10 further is coupled to at least one hemostatic port 18, e.g., a Touhy-Borst connector, which is per se known in the art.
  • Hemostatic port 18, bore 68 and working lumen 58 of catheter 41 are sized to permit the advancement of conventional angioplasty catheters, stent delivery systems, thrombectomy systems, and other devices to a vascular treatment site via working lumen 58.
  • proximal catheter assembly 10 may be used in conjunction with catheter 41 during a medical procedure to provide a substantially continuous rate of natural, physiologically-regulated aspiration through working lumen 58 and, optionally, suction-assisted aspiration.
  • catheter 41 may be disposed in a patient's artery and occlusive element 42 may be deployed.
  • the natural aspiration may be provided through working lumen 58 when a venous return line (not shown) , which is coupled to blood outlet port 26, is introduced into a remote vein.
  • this arterial -venous shunt allows blood flow in the patient's artery that is distal of occlusive element 42 to flow in a retrograde fashion through working lumen 58, through one-way check valve 22, through outlet port 26, through the venous return line and back into the remote vein.
  • This method which utilizes the difference between venous and arterial pressure, may be used to provide a substantially continuous rate of aspiration at a treatment site before, during and after a medical procedure, to ensure that emboli generated during the medical procedure are directed into working lumen 58 for safe removal.
  • a filter (not shown) may be coupled between blood outlet port 26 and the venous return line so that emboli may be removed and filter blood reperfused into the venous vasculature.
  • a medical procedure may be performed through hemostatic port 18 and working lumen 58.
  • additional suction-assisted aspiration may be provided at the treatment site via syringe 16. It is preferred that the additional suction provided by syringe 16 only is used in conjunction with the above-described natural aspiration technique for a limited period of time, e.g., at the time a vascular lesion is being traversed or disrupted, to ensure that trauma to the vessel wall due to the external suction is reduced.
  • syringe 16 may be used to temporarily establish antegrade flow, e.g., to infuse contrast agents, drugs, lytic agents or other therapeutic agents.
  • catheter 41 which may be used in conjunction with proximal catheter assembly 10, preferably comprises inner layer 60 covered with a layer of flat stainless steel wire braid 61 and polymer cover 62.
  • Inflation lumen 63 is disposed within polymer cover 62 and couples inflation port 20 to occlusive element 42.
  • a proximal end of working lumen 58 is in fluid communication with external suction/infusion port 14, hemostatic port 18, and blood outlet port 26, as described hereinabove with respect to FIG. 1.
  • FIGS. 3 an alternative proximal catheter assembly constructed in accordance with principles of the present invention is described.
  • FIG. 3A provides a top view of proximal catheter assembly 100, which is coupled to catheter 141 having proximal and distal ends and working lumen 158 extending therebetween.
  • Catheter 141 preferably is provided in accordance with catheter 41 of FIGS. 1-2.
  • Proximal catheter assembly 100 preferably comprises handle 110 and hub 112, each having proximal and distal ends. The distal end of hub 112 is configured to receive and sealingly engage the proximal end of catheter 141, as shown in a top sectional view in FIG. 3B.
  • Working lumen 158 of catheter 141 is in fluid communication with bore 113 of hub 112, which in turn is in fluid communication with lumen 136 of tubing 135, as described in detail with respect to FIGS. 4 hereinbelow.
  • Proximal catheter assembly 100 further comprises inflation port 120, which preferably is coupled to hub 112 and is in fluid communication with an inflation lumen of catheter 141, e.g., inflation lumen 63 of FIG. 1.
  • the inflation lumen of catheter 141 further is in fluid communication with occlusive element 142 disposed at the distal end of catheter 141, so that occlusive element 142 may be deployed via inflation port 120 and the inflation lumen.
  • Hub 112 of proximal catheter assembly 100 further is coupled to blood outlet port 126, which in turn is coupled to a venous return line (not shown) that is adapted to be inserted into a patient's venous vasculature, as described hereinabove.
  • one-way check valve 122 is disposed between distal hub 112 and blood outlet port 126 to ensure that flow through one-way check valve 122 occurs only in the direction indicated.
  • one-way check valve 122 preferably comprises ball 123 that is configured to plug an opening of one-way check valve 122, if necessary, to prevent flow from occurring from outlet port 126 into bore 113 and/or working lumen 158.
  • External suction/infusion port 114 is in fluid communication with working lumen 158 of catheter 141, as shown in FIGS. 4B-4C. External suction/infusion port 114 is configured to provide external suction through working lumen 158 when a syringe is coupled to port 114. Alternatively, as described hereinabove with respect to port 14 of the embodiment of FIG. 1, port 114 may be used to infuse fluid into the vessel.
  • Handle 110 further comprises at least one hemostatic port 118 that is in fluid communication with working lumen 158 of catheter 141.
  • Hemostatic port 118 and working lumen 158 are sized to permit the advancement of conventional angioplasty catheters, stent delivery systems, and thrombectomy systems to a vascular treatment site via working lumen 158.
  • handle 110 further comprises a section of tubing 135 that is disposed substantially within handle 110.
  • Tubing 135 comprises lumen 136 that is in fluid communication with hemostatic port 118, external suction/infusion port 114, bore 113 of hub 112 and working lumen 158 of catheter 141.
  • Handle 110 further comprises roller clamp valve 129, which is configured to selectively inhibit flow through handle 110.
  • Roller clamp valve 129 preferably comprises roller clamp 130 that is mounted on shaft 131, whereby shaft 131 is configured for longitudinal motion within angled slot 132, as shown from a top sectional view in FIG. 3B and from side sectional views in FIGS. 4B-4C.
  • Angled slot 132 is disposed within a portion of handle 110 and tapers from a proximal point in which it is substantially adjacent to tubing 135, as shown in FIG. 4B, to a distal point in which it is further away from tubing 135, as shown in FIG. 4C.
  • roller clamp 130 When roller clamp 130 is provided in a distal position within angled slot 132, it will not inhibit fluid transfer occurring within lumen 136 of tubing 135, as shown in FIG. 4B. However, when roller clamp 130 is disposed in a proximal position within angled slot 132, as shown in FIG. 4C, it impinges upon tubing 135 and inhibits flow within lumen 136. In effect, roller clamp valve 129 serves as a switch that allows a physician to selectively inhibit fluid transfer between working lumen 158 of catheter 141 and hemostatic port 118. By inhibiting flow through lumen 136 of tubing 135, roller clamp valve 129 may prevent "back-bleed" from occurring when hemostatic port 118 is open, e.g., when catheter 141 is advanced over a guidewire to a treatment site.
  • proximal catheter assembly 100 then may be used in conjunction with catheter 141 during a medical procedure to provide a substantially continuous rate of natural aspiration and, optionally, syringe-assisted aspiration via external suction/infusion port 114.
  • the preferred method for obtaining the substantially continuous rate of natural aspiration using proximal catheter assembly 100 is the same technique described hereinabove with respect to proximal catheter assembly 10 of FIG. 1, which disposes a venous return line in a remote vein and utilizes the difference between venous and arterial pressure to achieve retrograde flow at a treatment site.
  • proximal catheter assembly 200 preferably is constructed in accordance with proximal catheter assembly 100 of FIGS. 3A-4C, except as noted below.
  • Proximal catheter assembly 200 is coupled to catheter 241 having proximal and distal ends and working lumen 258 extending therebetween.
  • Catheter 241 preferably is constructed as described hereinabove with respect to catheter 41 of FIGS. 1-2.
  • Proximal catheter assembly 200 preferably comprises handle 210 and hub 212, each having proximal and distal ends.
  • Working lumen 258 of catheter 241 is in fluid communication with bore 213 of hub 212, which in turn is in fluid communication with handle 210, as described hereinabove with respect to the embodiment of FIGS. 3-4.
  • Hub 212 of proximal catheter assembly 200 further is coupled to tubing 224, which in turn preferably is coupled to a venous return line (not shown) that is adapted to be inserted into a patient's venous vasculature, as described hereinabove.
  • External suction/infusion port 214 is in fluid communication with working lumen 258 of catheter 241, as described in FIGS.
  • External suction/infusion port 214 is configured to provide external suction through working lumen 258 when a syringe is coupled to port 214.
  • port 214 may be used to infuse fluid into a vessel.
  • check/relief valve 222 is disposed within hub 212 and configured to perform functions associated with conventional check valves and relief valves, as described in FIGS. 6A-6C hereinbelow.
  • check/relief valve 222 may be provided as a separate component, i.e., not disposed within hub 212, so long as valve 222 is in fluid communication with tubing 224, working lumen 258, and external suction/infusion port 214 via bore 213.
  • Check/relief valve 222 preferably comprises frame 250 and at least one flap 252 affixed to interior surface 257 of frame 250, as shown in FIG. 5C from a cross-sectional view along line B--B of FIG. 5B.
  • a plurality of distinct, adjacent flaps 252 may be provided that are configured to be sealingly engaged with each other, as shown in FIG. 5C.
  • membrane 261 may be affixed about its perimeter to interior surface 257 of frame 250, whereby flaps 252 are formed from at least one lateral or longitudinal slit 253 disposed in membrane 261.
  • Check/relief valve 222 preferably comprises a circular configuration and is disposed within valve housing 237 of hub 212, which also preferably comprises a circular configuration. It is desirable that exterior surface 258 of frame 250 comprises a diameter that is slightly smaller than the diameter of interior surface 259 of valve housing 237, as shown in FIG. 5C, so that an insignificant amount of fluid is permitted to flow therebetween .
  • Check/relief valve 222 preferably further comprises first and second pivot pins 239 and 240, which are affixed to opposing ends of frame 250, as shown in FIG. 5C.
  • First and second pivot pins 239 and 240 are disposed within first and second bores 244 and 245 of valve housing 237, respectively. This permits frame 250 to rotate with respect to valve housing 237.
  • check/relief valve 222 preferably further comprises proximal and distal stops 246 and 247 that extend radially into channel 268 of valve housing 237. Proximal and distal stops 246 and 247 inhibit rotation of frame 250 with respect to valve housing 237, for purposes described hereinafter.
  • FIGS. 6A-6C a preferred method for using check/relief valve 222 is provided.
  • the arrows indicate the direction in which blood flows when the natural, physiologically-regulated flow is provided through working lumen 258 of catheter 241.
  • catheter 241 is disposed in a patient's artery and occlusive element 42 of FIG. 1 may be deployed. Natural aspiration may be established through working lumen 258 when a venous return line (not shown), which is coupled to tubing 224, is introduced into a remote vein.
  • this arterial-venous shunt allows blood flow in the patient's artery that is distal of occlusive element 42 to flow in a retrograde fashion through working lumen 258, through channel 268 of valve 222, into tubing 224, through blood outlet port 26 of FIG. 1, through the venous return line and back into the remote vein.
  • a filter (not shown) may be coupled between blood outlet port 26 of FIG. 1 and the venous return line so that emboli may be removed and filtered blood reperfused into the venous vasculature.
  • check/relief valve 222 assumes an "open position" wherein frame 250 is substantially parallel to blood flow, as shown in FIG. 6A. In the open position, check/relief valve 222 functions as a conventional check valve by permitting the flow of blood and emboli exclusively in the direction indicated, i.e., fluid is permitted to flow around frame 250 and into tubing 224.
  • check/relief valve 222 Referring now to FIG. 6B, operation of check/relief valve 222 is described where a physician applies a relatively low or moderate rate of suction- assisted aspiration via external suction/infusion port 214, e.g., using a syringe.
  • suction-assisted aspiration causes flow to occur in the direction indicated by the arrows in FIG. 6B .
  • Suction-assisted aspiration through bore 213 causes frame 250 of check/relief valve 222 to rotate about pivot pins 239 and 240 until the frame contacts proximal and distal stops 246 and 247.
  • Continued suction-assisted aspiration through bore 213 holds check/relief valve 222 in this "closed position, " so that frame 250 is substantially orthogonal to fluid flow through channel 268.
  • check/relief valve 222 functions as a conventional check valve by inhibiting flow through channel 268 when suction-assisted aspiration is applied via port 214.
  • check/relief valve 222 serves to ensure that the desired rate of suction-assisted aspiration is imposed upon the patient's vessel via working lumen 258, instead of aspirating fluid from tubing 224 and the venous return line.
  • a predetermined threshold i.e., a level that generally will not cause damage to a patient's vessel
  • flaps 252 of check/relief valve 222 are substantially sealingly engaged with adjacent flaps to inhibit fluid flow through frame 250. In the closed state, the suction force imposed upon flaps 252 by external suction/infusion port 214 does not overcome the rigidity of flaps 252.
  • flaps 252 of check/relief valve 222 assume an "open state," i.e., they no longer sealingly engage adjacent flaps. Instead, flaps 252 temporarily are drawn toward bore 213 by the excessive suction force, as shown in FIG. 6C. This forms a gap between adjacent flaps 252 and allows blood to flow between tubing 224 and bore 213 via channel 268, as indicated by the arrows in FIG. 6C.
  • check/relief valve 222 functions as a conventional relief valve when the rate of suction-assisted aspiration exceeds a predetermined threshold.
  • the relief feature of check/relief valve 222 allows blood to be partially drawn from tubing 224 and the venous line, which reduces the blood drawn from working lumen 258 and the patient's vessel. By mitigating the rate of excessively high suction-assisted aspiration imposed on the patient's vessel using check/relief valve 222, damage to the patient's vessel can be reduced.
  • flaps 252 of check/relief valve 222 transition from the open state of FIG. 6C to the closed state of FIG. 6B. This allows the desired rate of aspiration to be imposed exclusively upon working lumen 258. Additionally, when suction-assisted aspiration is no longer applied, check/relief valve 222 automatically transitions from the closed position of FIG. 6B to the open position of FIG. 6A to re-establish natural aspiration via tubing 224 and the venous line.
  • the rigidity of flaps 252 preferably is proportional to a predetermined aspiration threshold rate and may be tailored for each particular intervention. The rigidity of flaps 252 may be established or varied by varying the material properties of membrane 261.
  • check/relief valve 222 of the present invention may be used when apparatus 200 exclusively has a potential for suction-assisted aspiration, and is not capable of the natural, physiologically-regulated aspiration described hereinabove.
  • tubing 224 may be coupled to a fluid source, e.g., saline, in lieu of being coupled to the venous return line or the atmosphere. Then, saline will be drawn through tubing 224, into channel 268 and through bore 213 to mitigate the suction-assisted aspiration rate imposed within working lumen 258.
  • check/relief valve 322 comprises frame 350 and flaps 352, which preferably are provided in accordance with frame 250 and flaps 252 of FIGS. 5-6, respectively.
  • frame 350 comprises hinge 339 in lieu of pivot pins 239 and 240.
  • valve housing 337 preferably comprises inner ring 347 having aperture 348, in lieu of proximal and distal stops 346 and 347.
  • Frame 350 preferably comprises a circular configuration having enlarged side region 338.
  • Enlarged side region 338 may be coupled to hinge 339, e.g., a rod that is configured for rotational motion with respect to bore 345 of valve housing 337.
  • hinge 339 may comprise any suitable hinge that permits rotation of frame 350 between the positions depicted in FIGS. 8A-8B, for purposes described hereinafter.
  • FIGS. 8 the operation of check/relief valve 322 is described, and is substantially similar to the operation of check/relief valve 222 of FIGS. 6A-6C.
  • catheter 341 is disposed in a patient's artery and occlusive element 42 of FIG. 1 is deployed. Natural aspiration may be provided through working lumen 358 when a venous return line (not shown) , which is coupled to tubing 324, is introduced into a remote vein, as described hereinabove.
  • a venous return line (not shown)
  • valve 322 is provided in an "open position, " whereby frame 350 is substantially parallel to blood flow, as shown in FIG. 8A. In the open position, frame 350 does not substantially impede blood flow through channel 368.
  • check/relief valve 322 In the closed position, check/relief valve 322 functions as a conventional check valve to ensure that fluid is not drawn from tubing 324, when the rate of suction-assisted aspiration is below a predetermined threshold, but rather from the patient's vessel via working lumen 358, e.g., to remove emboli.
  • check/relief valve 322 When the rate of suction-assisted aspiration remains below the predetermined threshold, check/relief valve 322 remains in a "closed state, " whereby flaps 352 are substantially sealingly engaged with adjacent flaps to inhibit fluid flow through frame 350 and aperture 348. [0078] Referring now to FIG. 8C, the rate of suction- assisted aspiration introduced via the external suction/infusion port exceeds a predetermined aspiration threshold. The excessively high rate of suction-assisted aspiration causes flow through bore 313 to exert a suction force upon frame 350 and flaps 352 that exceeds the predetermined rigidity of flaps 352.
  • check/relief valve 322 This causes check/relief valve 322 to assume an "open state," i.e., whereby flaps 352 are not sealingly engaged with adjacent flaps. Flaps 252 temporarily are drawn toward bore 213 by the excessive suction force, as shown in FIG. 8C, to form a gap between adjacent flaps 252. This allows fluid from tubing 324 to be drawn toward bore 313. As described hereinabove, this relief feature of check/relief valve 322 allows blood to be partially drawn from tubing 324 to mitigate the excessively high rate of aspiration imposed upon working lumen 358 and a patient's vessel .

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un ensemble cathéter proximal (200) qui est configuré pour faciliter l'aspiration naturelle ou assistée par dépression à travers une lumière (258) de cathéter. L'ensemble cathéter proximal (200) comprend une valve polyvalente (222) configurée pour exécuter des fonctions associées aux soupapes de retenue et aux soupapes de sûreté classiques. La valve (222) est configurée pour réguler le sens de l'écoulement de fluide et pour réguler le débit de l'aspiration assistée par dépression par la lumière du cathéter. Lorsque le débit de l'aspiration assistée par dépression dépasse un seuil prédéterminé, la valve (222) s'ouvre pour permettre au fluide d'être aspiré de la tubulure couplée à l'ensemble cathéter proximal (200), ceci limitant les débits d'aspiration excessivement élevés imposés au vaisseau du patient.
PCT/US2003/009514 2002-03-29 2003-03-27 Valve d'aspiration pour catheter WO2003082377A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003218438A AU2003218438A1 (en) 2002-03-29 2003-03-27 Aspiration valve for catheter

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US10/112,807 2002-03-29
US10/112,807 US6960189B2 (en) 2002-03-29 2002-03-29 Proximal catheter assembly allowing for natural and suction-assisted aspiration
US10/138,013 US7033336B2 (en) 2002-03-29 2002-05-01 Proximal catheter assembly having a relief valve
US10/138,013 2002-05-01
US10/278,101 2002-10-21
US10/278,101 US7004931B2 (en) 2002-03-29 2002-10-21 Proximal catheter assembly having a self-limiting aspiration valve

Publications (1)

Publication Number Publication Date
WO2003082377A1 true WO2003082377A1 (fr) 2003-10-09

Family

ID=28678829

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/009514 WO2003082377A1 (fr) 2002-03-29 2003-03-27 Valve d'aspiration pour catheter

Country Status (2)

Country Link
AU (1) AU2003218438A1 (fr)
WO (1) WO2003082377A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11452841B2 (en) 2019-04-11 2022-09-27 Covidien Lp Aspiration catheter system

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4310017A (en) * 1980-01-30 1982-01-12 Burron Medical Inc. Backflow check valve for use with IV administration sets
US4668215A (en) * 1986-05-15 1987-05-26 Dexide, Inc. Irrigator-evacuator control for surgical procedures
US5453097A (en) * 1994-08-15 1995-09-26 Paradis; Joseph R. Control of fluid flow
US5496270A (en) * 1994-09-26 1996-03-05 Megadyne Medical Products, Inc. Tri-tubular suction irrigation device
US5919174A (en) * 1997-02-03 1999-07-06 Sorenson Critical Care, Inc. Suction valve assembly

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4310017A (en) * 1980-01-30 1982-01-12 Burron Medical Inc. Backflow check valve for use with IV administration sets
US4668215A (en) * 1986-05-15 1987-05-26 Dexide, Inc. Irrigator-evacuator control for surgical procedures
US5453097A (en) * 1994-08-15 1995-09-26 Paradis; Joseph R. Control of fluid flow
US5496270A (en) * 1994-09-26 1996-03-05 Megadyne Medical Products, Inc. Tri-tubular suction irrigation device
US5919174A (en) * 1997-02-03 1999-07-06 Sorenson Critical Care, Inc. Suction valve assembly

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11452841B2 (en) 2019-04-11 2022-09-27 Covidien Lp Aspiration catheter system

Also Published As

Publication number Publication date
AU2003218438A1 (en) 2003-10-13

Similar Documents

Publication Publication Date Title
US7004931B2 (en) Proximal catheter assembly having a self-limiting aspiration valve
US6960189B2 (en) Proximal catheter assembly allowing for natural and suction-assisted aspiration
CA2497858C (fr) Catheter comportant un element compliant configure pour la regulation des vitesses d'aspiration
EP1539275B1 (fr) Systeme d'aspiration du sang
US6855136B2 (en) Infusion catheter having an atraumatic tip
JP2024042080A (ja) 急性虚血性脳卒中を治療するための方法及びシステム
EP1289596B1 (fr) Systeme de protection contre l'embolisation pour interventions vasculaires
US8002725B2 (en) Embolic protection and plaque removal system with closed circuit aspiration and filtering
WO2000076390A3 (fr) Methodes et appareil a configuration plate permettant de reduire les risques d'embolie lors du traitement d'une affection de l'artere carotide
AU2002214653A1 (en) A multilumen catheter for minimizing limb ischemia
JP4865825B2 (ja) 頸動脈疾患の処置中に塞栓形成を軽減するための方法および低プロフィール装置
US20230149034A1 (en) System and methods for removing undesirable material within a circulatory system utilizing during a surgical procedure
WO2014204860A1 (fr) Procédés et systèmes pour le traitement d'un accident cérébral ischémique aigu
JP2011087971A (ja) 頸動脈疾患の処置中に塞栓形成を軽減するための方法および低プロフィール装置
WO2003082377A1 (fr) Valve d'aspiration pour catheter

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EC EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SK SL TJ TM TR TT TZ UA UG UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZM ZW AM AZ BY KG KZ MD RU TJ TM AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LU MC NL PT RO SE SI SK TR BF BJ CF CG CI CM GA GN GQ GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

WWW Wipo information: withdrawn in national office

Country of ref document: JP