US20170100142A1 - Systems and methods for management of thrombosis - Google Patents
Systems and methods for management of thrombosis Download PDFInfo
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- US20170100142A1 US20170100142A1 US15/288,527 US201615288527A US2017100142A1 US 20170100142 A1 US20170100142 A1 US 20170100142A1 US 201615288527 A US201615288527 A US 201615288527A US 2017100142 A1 US2017100142 A1 US 2017100142A1
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Abstract
An aspiration system includes an aspiration catheter including a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of an elongate tubular member and into the vasculature of a subject, an elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member, a high pressure injection lumen extending within the elongate support member and having a distal end including a curved portion configured to change a direction of fluid flow by at least about 90°, at least one orifice located at the distal end of the high pressure injection lumen configured to allow liquid to be released into the lumen of the tubular aspiration member, and an annular seal carried by the tubular aspiration member and configured to create a liquid seal against the inner surface of the elongate tubular member.
Description
- This application claims the benefit of priority to U.S. Provisional Patent Application No. 62/239,795, filed on Oct. 9, 2015, and U.S. Provisional Patent Application No. 62/239,946, filed on Oct. 11, 2015, both of which are herein incorporated by reference in their entirety for all purposes. Priority is claimed pursuant to 35 U.S.C. §119.
- The field of the invention generally relates to an aspiration system for removing, by aspiration, undesired matter such as a thrombus from a fluid carrying cavity, duct, or lumen of the body, such as a blood vessel.
- Thrombosis is managed by pharmacologic means and by interventional means. These include thrombectomy, and combinations of thrombectomy with pharmacologic agents. Thrombectomy methods include breaking up and in many cases removing thrombus from a patient having thrombosis. Thrombectomy may be mechanical or non-mechanical, and may use catheter-based cutting or macerating elements, saline jets or aspiration of the thrombus.
- A treatment method for removing undesired matter such as thrombus from a blood vessel of a patient involves use of an aspiration catheter having elongate shaft formed with an aspiration lumen extending therein. An aspiration catheter may also include a guidewire lumen for placement of a guidewire, which is used to guide the aspiration catheter to a target site in the body. By applying a vacuum (i.e. negative pressure) to a proximal end of the aspiration lumen, for example, with a syringe having a hub that is connected to the proximal end of the aspiration catheter, the matter can be aspirated into an aspiration port at the distal end of the aspiration catheter, into the aspiration lumen, and thus be removed from the patient.
- In one embodiment, an aspiration system for removal of material from a lumen, cavity or duct of a patient includes an aspiration catheter having a proximal end and a distal end and configured to be inserted through a lumen of an elongate tubular member, the elongate tubular member configured for insertion into the vasculature of a subject and having a proximal end, a distal end, the lumen extending from the proximal end to the distal end, and an inner surface defined by the lumen, the aspiration catheter including a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of the elongate tubular member at the distal end of the elongate tubular member and into the vasculature of the subject, an elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member, a high pressure injection lumen extending within the elongate support member and having a proximal end adjacent the proximal end of the aspiration catheter and a distal end adjacent the distal end of the tubular aspiration member, the distal end of the high pressure injection lumen including a curved portion configured to change a direction of fluid flow through the high pressure injection lumen by at least about 90°, at least one orifice located at the distal end of the high pressure injection lumen configured to allow liquid injected through the high pressure injection lumen to be released into the lumen of the tubular aspiration member, and an annular seal carried by the tubular aspiration member and configured to create a liquid seal against the inner surface of the elongate tubular member.
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FIG. 1 is a side elevation view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 2 is a cross-sectional view taken along line 2-2 ofFIG. 1 . -
FIG. 3 is a sectional view of a standard aspiration system during aspiration. -
FIG. 4 is a sectional view of the embodiment ofFIGS. 1 and 2 during aspiration. -
FIG. 5 is a sectional view of a standard aspiration system during aspiration, with a guidewire in place through the lumens. -
FIG. 6 is a sectional view of the embodiment ofFIGS. 1 and 2 during aspiration, with a guidewire in place through the lumens. -
FIG. 7 is a view of the lumen cross-section in a standard aspiration catheter or in the distal tube of the embodiment ofFIGS. 1 and 2 . -
FIG. 8 is a view of the lumen cross section in a portion of a guiding catheter of the embodiment ofFIGS. 1 and 2 . -
FIG. 9 is a view of the lumen cross-section in a standard aspiration catheter or in the distal tube of the embodiment ofFIGS. 1 and 2 , with a guidewire in place through the lumen. -
FIG. 10 is a view of the lumen cross section in a portion of a guiding catheter of the embodiment ofFIGS. 1 and 2 , with a guidewire in place through the lumen. -
FIG. 11 is a view of an aspiration system according to an embodiment of the present disclosure during aspiration. -
FIG. 12 is a perspective view of a distal section of an aspiration (thrombectomy) catheter according to an embodiment of the present disclosure. -
FIG. 13 is a sectional view of an aspiration system according to an embodiment of the present disclosure prior to aspiration. -
FIG. 14 is a sectional view of an aspiration system according to an embodiment of the present disclosure during aspiration. -
FIG. 15A is a sectional view of an aspiration system according to an embodiment of the disclosure invention. -
FIG. 15B is a sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 15C is a sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 16 is a sectional view of an aspiration catheter according to an embodiment of the present disclosure. -
FIG. 17 is a cross-sectional view of the aspiration catheter ofFIG. 16 , taken through line 17-17. -
FIG. 18 is a partially sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 19 is a partially sectional view of aspiration system according to an embodiment of the present disclosure. -
FIG. 20 is a sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 21 is a sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 22 is a partially sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 23 is a partially sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 24 is a partially sectional view of an aspiration system according to an embodiment of the present disclosure. -
FIG. 25 is a perspective view of an aspiration system according to an embodiment of the present disclosure in use within a blood vessel. -
FIG. 26A is a perspective view of an embodiment of a catheter joint. -
FIG. 26B is a perspective view of a component of the catheter joint ofFIG. 26A . -
FIG. 27 . is a perspective view of an aspiration catheter assembled with a dipping process according to an embodiment of the present disclosure. -
FIG. 28 is a perspective view of a distal section of an aspiration (thrombectomy) catheter according to an embodiment of the present disclosure. -
FIG. 29 is a sectional view of an embodiment of a saline injection aspiration (thrombectomy) catheter according to an embodiment of the present disclosure, with a guidewire in place through the lumens. -
FIG. 30 is a plan view of a distal end of an alternative embodiment of the saline injection aspiration (thrombectomy) catheter ofFIG. 29 . -
FIG. 31 is a sectional view of the saline injection aspiration (thrombectomy) catheter ofFIG. 30 , taken along the line 31-31. -
FIG. 32 is a detail view of the saline injection aspiration (thrombectomy) catheter ofFIG. 31 withincircle 32. -
FIG. 33 is a perspective view of a distal section of a saline aspiration (thrombectomy) catheter according to an embodiment of the present disclosure. -
FIG. 34A is a cross-section of the saline injection aspiration (thrombectomy) catheter ofFIG. 33 , taken along theline 34A-34A. -
FIG. 34B is a cross-section of the saline injection aspiration (thrombectomy) catheter ofFIG. 33 , taken along theline 34B-34B. -
FIG. 35 is a perspective view of a proximal section of a saline aspiration (thrombectomy) catheter according to an embodiment of the present disclosure. -
FIG. 36 is a perspective view of a distal section of a saline aspiration (thrombectomy) catheter according to an embodiment of the present disclosure. -
FIG. 37 is a perspective view of a slotted mandrel according to an embodiment of the present disclosure. -
FIG. 38 is a cross-sectional view of the slotted mandrel ofFIG. 37 as used in a dipping process according to an embodiment of the present disclosure. -
FIG. 39 . is a top view of a marker band during an assembly process according to an embodiment of the present disclosure. -
FIG. 40 . is a perspective view of a marker band during an assembly process according to an embodiment of the present disclosure. -
FIG. 41 . is an end view of a marker band during an assembly process according to an embodiment of the present disclosure. -
FIG. 42 . is an end view of a marker band during an assembly process using the slotted mandrel ofFIG. 37 according to an embodiment of the present disclosure. -
FIG. 43 is a plan view of a system for aspiration according to an embodiment of the present disclosure. -
FIG. 44A is a detailed view of an aspiration monitoring system according to a first embodiment or the present disclosure. -
FIG. 44B is a view of an aspiration monitoring system according to a second embodiment of the present disclosure. -
FIG. 44C is a view of an aspiration monitoring system according to a third embodiment of the present disclosure. -
FIG. 45A is a sectional view of an aspiration catheter in a blood vessel prior to contact with a thrombus. -
FIG. 45B is a sectional view of an aspiration catheter in a blood vessel upon contact with a thrombus. -
FIG. 45C is a sectional view of an aspiration catheter during a loss of vacuum. -
FIG. 45D is a sectional view of thrombi being aspirated through an aspiration catheter. -
FIG. 46A is a graphic representation of pressure vs. time for the condition ofFIG. 45A . -
FIG. 46B is a graphic representation of pressure vs. time for the condition ofFIG. 45B . -
FIG. 46C is a graphic representation of pressure vs. time for the condition ofFIG. 45C . -
FIG. 46D is a graphic representation of pressure vs. time for the condition ofFIG. 45D . -
FIG. 47 is a plan view of a system for aspiration according to another embodiment of the present disclosure. -
FIG. 48 is a plan view of a system for aspiration according to another embodiment of the present disclosure. -
FIG. 49 is a detailed view of an aspiration monitoring system of the system for aspiration ofFIG. 48 . -
FIG. 50 is a plan view of a system for aspiration according to another embodiment of the present disclosure. -
FIG. 51 is a detailed view of an aspiration monitoring system of the system for aspiration ofFIG. 50 . -
FIG. 52 is a diagrammatic view of a system for aspirating thrombus according to an embodiment of the present disclosure. -
FIG. 53 is a diagrammatic view showing more detail of the proximal portion of the system for aspirating thrombus ofFIG. 52 . -
FIG. 54 is a diagrammatic view of the distal end portion of the system for aspirating thrombus ofFIG. 52 . -
FIG. 55A is a perspective view of an aspiration system according to an embodiment of the present disclosure in a first configuration. -
FIG. 55B is a perspective view of the aspiration system ofFIG. 55A in a second configuration. -
FIGS. 56A-56C are perspective views of an aspiration catheter according to an embodiment of the present disclosure in three different configurations. -
FIG. 57 is a perspective view of an aspiration catheter according to an embodiment of the present disclosure. -
FIG. 58 is a perspective view of a thrombectomy catheter according to an embodiment of the present disclosure. -
FIG. 59 is a perspective view of an aspiration catheter according to an embodiment of the present disclosure. -
FIG. 60 is a perspective view of an aspiration system according to an embodiment of the present disclosure. -
FIGS. 61A-61C are perspective views of an aspiration system according to an embodiment of the present disclosure in multiple configurations. -
FIG. 62 is a perspective view of an aspiration system according to an embodiment of the present disclosure. -
FIGS. 63A-63B are perspective views of an aspiration system according to an embodiment of the present disclosure. -
FIG. 64 is a perspective view of a component of an aspiration catheter according to an to an embodiment of the present disclosure. -
FIG. 65 is a perspective detail view of a portion of an aspiration catheter according to an embodiment of the present disclosure. -
FIG. 66 is a perspective view of a flow control system according to an embodiment of the present disclosure. -
FIG. 67 is a perspective view of a catheter system having a collapsible and expandable distal portion. -
FIG. 68A is a perspective view of a connection between a distal tube and a support member. -
FIG. 68B is a proximal end view of the connection inFIG. 68A . -
FIG. 69A is a view of a system for aspiration or fluid delivery. -
FIG. 69B is an end view of the distal end of the aspiration catheter of the system for aspiration or fluid delivery ofFIG. 69A . -
FIG. 70 is a detail view of the connection ofFIG. 69 . -
FIG. 71 is an alternative embodiment of the aspiration catheter ofFIG. 33 . -
FIG. 72 is an alternate embodiment of the aspiration catheter ofFIG. 33 . -
FIG. 73 is an alternate embodiment of the aspiration catheter ofFIG. 33 . - Referring first to
FIGS. 1 and 2 , the distal portion of an aspiration orthrombectomy system 100 is shown within ablood vessel 102 of a patient with thrombosis, including at least onethrombus 104. Theblood vessel 102 may comprise a vein or an artery. For example, theblood vessel 102 may comprise one or more veins of the legs, including, but not limited to the femoral or iliac veins, or one or more veins of the upper extremities, including, but not limited to the subclavian, internal jugular or axillary veins. Theblood vessel 102 may also comprise the inferior vena cava or superior vena cava. Theblood vessel 102 may comprise an artery including, but not limited to a pulmonary artery, a coronary artery, a cerebral artery, an internal carotid artery, a femoral artery, an iliac artery, or a renal artery. Thethrombectomy system 100 comprises athrombectomy catheter 106 and a guidingcatheter 108. The guidingcatheter 108 may, for example, have an outer diameter of 6 French, an inner lumen diameter of approximately 0.183 cm (0.072 inches), and have a total length of approximately 100 cm. Thethrombectomy catheter 106 is configured to be placed through theinner lumen 110 of the guidingcatheter 108. The guidingcatheter 108 may comprise a composite extruded and braided tubular structure, which has sufficient flexibility and pushability to reach atarget area 112. The guidingcatheter 108 may also have a pre-shaped tip. For example, the tip shape may aid in cannulating coronary arteries. Thethrombectomy catheter 106 comprises adistal tube 114 which is configured to be extendable out of theinner lumen 110 of the guidingcatheter 108, such that adistal end 116 of thedistal tube 114 can be advanced a desired length into theblood vessel 102 so that it can be placed adjacent thetarget area 112. Theproximal end 118 of thedistal tube 114 is configured to remain within theinner lumen 110 of the guidingcatheter 108, for example, at a region near thedistal end 120 of the guidingcatheter 108. In some embodiments, thethrombectomy catheter 106 includes aradiopaque marker 101, which may comprise a band secured to the thrombectomy catheter, and made from radiodense material, such as platinum, gold, or other similar materials. In some embodiments, thedistal tube 114 may be formed of polymeric materials containing radiopaque material, such as titanium dioxide (TiO2). - A sealing
member 124 is carried by theproximal end 118 of thedistal tube 114, and may comprise, for example, an annular seal attached to an outercylindrical surface 122 of thedistal tube 114. Thethrombectomy catheter 106 also comprises asupport member 126, for example a wire, a hypo tube, or a composite shaft, which is secured to thedistal tube 114 by adhesive, mechanical attachment or other manners described herein. Thesupport member 126 may be relatively stiff and may have a relatively small outer diameter so that it does not block thelumen 130 of thedistal tube 114. The sealingmember 124 is configured to seal off anannulus 142 between thedistal tube 114 and aninner surface 123 defined by theinner lumen 110 of the guidingcatheter 108 so that anextended lumen 128 is created, at least when a negative pressure gradient is placed between the proximal end 144 (FIGS. 4 and 6 ) of the guidingcatheter 108 and thedistal end 116 of thedistal tube 114. The negative pressure gradient may result by coupling avacuum source 146 to the proximal end of the guidingcatheter 108. For example, a y-connector 148 may be sealingly coupled to theproximal end 144 of the guidingcatheter 108, and thesupport member 126 may extend through the y-connector 148 and be sealed by the proximal seal 150 (e.g. hemostatic valve) of the y-connector 148. Thevacuum source 146 may be coupled to the side port 152 (e.g. luer) of the y-connector 148. In some embodiments, thevacuum source 146 may comprise a 20 ml syringe, 30 ml syringe, or a larger syringe, that is lockable in its evacuated condition. An example is the VacLok® syringe sold by Merit Medical Systems, Inc. of South Jordan, Utah. In some embodiments, the syringe may be attached to theside port 152 of the y-connector 148 via extension tubing known in the art. In use, when thedistal end 116 of thedistal tube 114 is extended out of thedistal end 120 of the guidingcatheter 108 into the vasculature and adjacent athrombus 104, and the sealingmember 124 is sealingly located within theinner lumen 110 of the guidingcatheter 108, the negative pressure gradient caused by the application of thevacuum source 146 causes thethrombus 104, or at least a portion thereof, to be aspirated through theextended lumen 128. While being aspirated, thethrombus 104, or a portion thereof, first enters thelumen 130 of thedistal tube 114 and then enters thelumen cross-section inner lumen 110 of the guidingcatheter 108, not already taken up by the support member 126 (FIG. 8 ), or by thesupport member 126 and a guidewire 134 (FIG. 10 ), if a guidewire is left in place within thelumens member 124 assures that blood 132 (FIGS. 1 and 2 ) will not enter into the extended lumen 128 (the combination oflumen 130 and thelumen cross-section 154 of the inner lumen 110) through location A. - Blood has a non-Newtonian viscosity, which is known to vary depending on the shear rate the blood experiences. The mean viscocity of blood can also be varied by factors including the amount of heparinization, or anti-coagulation, employed during an interventional procedure, which may include a thrombectomy procedure. Viscosities of around 0.0025 pascal-seconds (2.5 centipoise) have been measured in heparinized blood, and as heparinization may lower normal blood viscosity, embodiments of a sealing
member 124 presented herein substantially prevent a liquid having a viscosity as low as 0.0025 pascal-seconds from passing through the annular space between the guidingcatheter 108 and thedistal tube 114 in a distal to proximal direction and into theinner lumen 110 of the guidingcatheter 108 proximal to the sealingmember 124 when a sufficient vacuum pressure is applied to theinner lumen 110 of the guidingcatheter 108 to cause at least some aspiration. In some embodiments, the sufficient vacuum pressure may be about −34,474 pascal (−5 pounds per square inch) or lower. In some embodiments, the sufficient vacuum pressure may be about −46,662 pascal (−6.8 pounds per square inch) or lower. In some embodiments, the sufficient vacuum pressure may range between about −82,737 pascal (−12 pounds per square inch) and about −95,526 pascal (−14 pounds per square inch). In some embodiments, the sufficient vacuum pressure may be about −89,631 pascal (−13 pounds per square inch). -
FIG. 11 illustrates the fluid flow 156 (e.g. blood, thrombus, macerated thrombus) out of theproximal end 118 of the distal tube 114 (lumen 130) and through theinner lumen 110 of the guidingcatheter 108. In the embodiment of thethrombectomy system 100 illustrated inFIGS. 1 and 2 , thedistal tube 114 has alumen 130 configured for tracking over theguidewire 134. The guidewire 134 (e.g. 0.014″ coronary guidewire) may be used to guide thethrombectomy catheter 106 through theblood vessel 102, with thelumen 130 of thedistal tube 114 acting as a single-operator exchange lumen. In some embodiments, the length of thislumen 130 may be between 5 cm and 35 cm. In some embodiments, it may be between 10 cm and 30 cm. In some embodiments, it may be between 15 cm and 25 cm. In some embodiments, it may be about 25 cm. As illustrated inFIG. 12 , thedistal tube 114 may have askive 158 at itsdistal end 116 and/or askive 160 at itsproximal end 118. Theskives distal tube 114 and thus thethrombectomy catheter 106 through theblood vessel 102, including anythrombus 104 or atherosclerotic plaque (not shown), past thedistal end 120 of the guidingcatheter 108, and in and out of the y-connector 148, including theproximal seal 150. Second, theskives lumen 130 of thedistal tube 114, thus lowering resistance to flow, and allowing, for example, relatively larger pieces or portions of thrombus to enter thelumen 130. Thedistal tube 114 inFIG. 12 is depicted in a slightly curved state so that theopenings lumen 130 face the viewer, so that theskives - Returning to
FIG. 11 , the sealingmember 124 is shown as an annular seal with adistally facing lip 166. Anannular concavity 167 extends circumferentially around thedistal tube 114 between thedistally facing lip 166 and the outercylindrical surface 122 of thedistal tube 114. In some embodiments, the sealingmember 124 may be made from a number of elastomeric materials including silicone, EPDM, polyurethane, or thermoplastic elastomers, such as PEBAX or Santoprene®. The thin-walled construction of thedistal tube 114 allows a finite gap G between thedistal tube 114 and theinner lumen 110 of the guidingcatheter 108, while still maintaining a relativelylarge lumen 130 in thedistal tube 114, in some embodiments as large as about 0.152 cm (0.060 inches) or larger (for a 6F guiding catheter compatible thrombectomy catheter 106). In some embodiments, the gap G is 0.003″ or more on each side, and thethin lip 166 may have a thickness T of about 0.000635 cm (0.00025 inches) to about 0.00508 cm (0.0020 inches). In other embodiments, the thickness T may be between about 0.0019 cm (0.00075 inches) and about 0.0038 cm (0.0015 inches). On other embodiments, the thickness T may be between about 0.00254 cm (0.001 inches) and about 0.00317 cm (0.00125 inches). With a gap G on the order of 0.0076 cm (0.003 inches) or more per side, there would be a risk of some movement of thrombus or macerated thrombus through theannulus 142 in direction d, due to agitation, and perhaps into theblood vessel 102, creating a risk of embolization of a loose thrombus. However, the addition of thedistally facing lip 166 allows theannulus 142 to be completely sealed whenever the vacuum source 146 (FIGS. 4 and 6 ) is applied, causing suction within theinner lumen 110 of the guiding catheter, and thus a pressure P2 proximal to thedistally facing lip 166 that is less than the pressure P1 distal to thedistally facing lip 166. Because thedistally facing lip 166 is made from a flexible material, and/or has a relatively small thickness T, the positive pressure gradient from the P1 (distal) side to the P2 (proximal side) (P1−P2>0) will cause thedistally facing lip 166 to be forced against theinner wall 168 of the guidingcatheter 108, thus sealing it. The maximum outer diameter of thedistally facing lip 166 may actually be smaller than the inner diameter of theinner lumen 110 of the guidingcatheter 108, because it will flex (e.g., by moment M) from a first configuration (FIG. 13 ) to a second configuration (FIG. 14 ) when activated by the positive pressure gradient (ΔP=P1−P2), in order to seal off theannulus 142. The benefit of having adistally facing lip 166 whose maximum outer diameter is smaller than the inner diameter of theinner lumen 110 of the guiding catheter 108 (when not activated by pressure), is that during tracking of thethrombectomy catheter 106, when thevacuum source 146 is not being applied, there is no seal between thedistally facing lip 166 and theinner wall 168 of the guidingcatheter 108, and thus there is less axial friction, thus making it easier to track and slide the thrombectomy catheter freely (longitudinal translation), providing both low axial resistance to motion (less drag), and high precision of motion (better “feel”). Thus, thedistally facing lip 166 only expands when it is needed (i.e. during aspiration). In some embodiments, the distal facinglip 166 may be made using a dipping process. In some embodiments, the dipping process may be a polyurethane dipping process. In some embodiments thedistally facing lip 166 may be made from non-elastomeric materials, such polyolefins, nylon, as the pressure-activated sealing does not require elastomeric compression. In some embodiments, thedistally facing lip 166 may be bonded to thedistal tube 114 with adhesive, epoxy, or by thermal bonding methods. In some embodiments, the seal should be liquid tight, or water tight (saline tight), and in some embodiments need not be air tight (gas tight). In some cases liquid tight may be defined as not allowing any substantial amount of blood to pass through theannulus 142. The sealing may be aided by blood viscosity, the length of the annulus 142 (distal to the sealing member 124), and the dimension of the gap G (FIG. 11 ). For example, a higher blood viscosity,longer annulus 142 length, and a smaller gap G dimension each serve alone or in combination to increase the sealing capacity (decrease the possibility of fluid passage through the annulus 142). - In some embodiments, the distal facing
lip 166 is configured to maintain a seal when a positive pressure gradient (ΔP=P1−P2) of about 46,662 pascal (350 mm Hg) or higher is maintained. In some embodiments, the aspiration pressure may be maintained using a vacuum pump as thevacuum source 146. In some embodiments, the vacuum pump provides a relatively constant pressure gradient of about 46,662 pascal (350 mm Hg) to about 53,328 pascal (400 mm Hg). In some embodiments, a 20 ml to 60 ml syringe is evacuated in order to serve as thevacuum source 146. In some embodiments, a 30 ml syringe is evacuated in order to serve as thevacuum source 146. In some embodiments, the evacuated 30 ml syringe provides a plateau pressure gradient of about 75,993 pascal (570 mm Hg) to about 89,626 pascal (670 mm Hg). As described, heparinized blood tends to have a viscosity of about 0.0025 pascal-seconds (2.5 cP) or higher. In some embodiments, thedistally facing lip 166 is configured to seal against theinner wall 168 of the guidingcatheter 108 so that a 0.0025 pascal-seconds liquid will not significantly pass distal to proximal when a distal to proximal positive pressure gradient (ΔP=P1−P2) of 46,662 pascal (350 mm Hg) is applied. In some embodiments, thedistally facing lip 166 is configured to not seal against theinner wall 168 of the guiding catheter and thus not stop the passage of a liquid from proximal to distal (i.e. through the annulus 142) when a proximal to distal positive pressure gradient (ΔP=P2−P1) of 46,662 pascal (350 mm Hg) is applied. -
FIG. 6 illustrates the aspiration flow path andFIGS. 9 and 10 illustrate the lumen cross-sections 136 b, 154 b if theguidewire 134 is left in place during aspiration.FIG. 4 illustrates the aspiration flow path andFIGS. 7 and 8 illustrate the lumen cross-sections 136 a, 154 a if theguidewire 134 is not left in place during aspiration, for example, if it is removed. Starting with this latter “no guidewire” condition,FIG. 7 illustrates alumen cross-section 136 a, which may represented by alumen 138 of astandard thrombectomy catheter 140 inFIG. 3 , or by thelumen 130 of thethrombectomy catheter 106 of an embodiment of the present disclosure inFIG. 4 . A comparison between the flow characteristics of thestandard thrombectomy catheter 140 and the embodiment of thethrombectomy system 100 ofFIGS. 1 and 2 is presented below. - The standard Hagen-Poiseuille Law flow equation used to calculate the flow of fluids (e.g. blood and/or macerated thrombus) is:
-
- where L is the length of a particular flow path,
- ΔP is the pressure gradient between one end of the flow path and the other end of the flow path,
- D is the diameter of the flow path, and
- μ is the viscosity of the fluid.
- Because luminal cross-sectional areas are often non-circular, the term Hydraulic Diameter (DH) is often substituted for diameter D. Hydraulic Diameter (DH) represents the effective diameter of a circular cross-section that behaves the same as a non-circular cross-section. The Hydraulic Diameter (DH) equation is:
-
- where A is the cross-sectional area of the lumen, and
- p is the summation of the perimeter of all of the luminal walls on cross-section.
- Combining these two equations, the standard Hagen-Poiseuille Law flow equation for a particular Hydraulic Diameter (DH) is:
-
- Using the Ohm's Law analogy for fluid flow, produces the equation:
-
- where R is the Resistance (to fluid flow), given thus by the equation:
-
- As differing lumen cross-sections 136, 154 are arrayed serially in the systems being discussed, the serial resistance equation will be used, the equation being:
-
RT=R 1 +R 2 ±R 3 . . . - where RT is the total resistance, and
- R1, R2, R3, etc. are individual serial resistances.
- The intention is to compare the total (flow) resistance of a first thrombectomy system (RT1) with the total resistance of a second thrombectomy system (RT2). Thus, the constant 128/π can be removed from the comparative term, leaving μL/DH 4. Additionally, though blood is non-Newtonian, and thus may exhibit variance in viscosity at different shear rates, the variation of the effective viscosity of a thrombus/macerated thrombus/blood slurry is not expected to be significant among the different lumen conditions described. Therefore, the viscosity (μ) term may also be removed from the comparative term. This leaves a comparative term of:
- Comparative Flow Resistance (RC)=L/DH 4
- Comparative Flow Resistance (RC) can be calculated using the units (1/cm3).
- Returning to the
standard thrombectomy catheter 140 ofFIG. 3 , the entire length L1 of the catheter in some models is about 140 cm and has a circular cross-sectional diameter D1 of itslumen 138 of about 0.11 cm (0.042 inches). Because thelumen 138 is circular, 0.11 cm (0.042 inches) is also the Hydraulic Diameter (DH). In comparison, the embodiment of thethrombectomy system 100 ofFIG. 4 , includes a first length L2 representing the length of thedistal tube 114 of thethrombectomy catheter 106, and in one embodiment L2 is about 25 cm. In this particular embodiment, thelumen 130 of thedistal tube 114 may have a circular cross-sectional diameter D2 of itslumen 130 of about 0.15 cm (0.060 inches) Thethrombectomy system 100 is inserted through a guidingcatheter 108 having a lumen inner diameter of about 0.183 cm (0.072 inches) and a length of about 100 cm, thus having a flow length L3 of about 100 cm. Assuming asupport member 126 embodiment comprising a substantially rectangular cross-section stainless steel wire having a minor dimension of about 0.0305 cm (0.012 inches) and a major dimension of about 0.0508 cm (0.020 inches), the Comparative Flow Resistance (RC) may be calculated for thestandard thrombectomy catheter 140 and thethrombectomy system 100 in their “no guidewire” configurations ofFIGS. 3 and 4 , respectively. Table 1 demonstrates that the Comparative Flow Resistance (RC1) of thethrombectomy system 100 is only about 15% the Comparative Flow Resistance (RC2) of thestandard thrombectomy catheter 140. -
TABLE 1 Condition Rc1 (1/cm3) Rc2 (1/cm3) Rc1/Rc2 No Guidewire (FIGS. 3 and 4) 160,822 1,080,926 0.15 Guidewire (FIGS. 5 and 6) 320,704 1,080,926 0.30 - The
standard thrombectomy catheter 140 inFIG. 5 has aguidewire 134 within the length of itslumen 138. Thethrombectomy system 100 ofFIG. 6 has a 0.014″ diameter guidewire 134 (0.036 cm) within the length of thelumen 130 of thedistal tube 114 and theinner lumen 110 of the guidingcatheter 108. Thethrombectomy system 100 ofFIG. 6 also has asupport member 126 having cross-sectional dimensions of 0.0305 cm×0.0508 cm (0.012 inches×0.020 inches) within the length of theinner lumen 110 of the guidingcatheter 108. Table 1 demonstrates that the Comparative Flow Resistance (RC1) of thethrombectomy system 100 is only about 30% the Comparative Flow Resistance (RC2) of thestandard thrombectomy catheter 140. This means that at a particular negative pressure gradient, the aspiration flow rate through thethrombectomy system 100 can be as much as 3.33 times more than the aspiration flow rate through thestandard thrombectomy catheter 140. - A test was performed wherein a 30 ml vacuum was locked onto an extraction syringe, and sealed with a closed stopcock. The extraction syringe and stopcock were then attached to a catheter/catheter system and the tip of the catheter placed in a beaker of water. The stopcock was then opened and the time was measured for the 30 ml syringe to fill with water. The data is listed in Table 2.
-
TABLE 2 Time to fill 30 ml System syringe (seconds) Medtronic Export AP 25 Prototype with 25 cm long, 0.147 cm 7.2 (.058 inches) ID distal tube, and 0.0305 cm × 0.0508 cm (0.012 inches × 0.020 inches) support member in 0.183 cm (.072 inches) ID × 100 cm long guiding catheter − distal tube extending 25 cm from guiding catheter Prototype with 25 cm long, 0.147 cm 6.7 (.058 inches) ID distal tube, and 0.0305 cm × 0.0508 cm (0.012 inches × 0.020 inches) support member in 0.183 cm (.072 inches) ID × 100 cm long guiding catheter − distal tube extending 5 cm from guiding catheter - Published data using a similar 30 ml syringe water vacuum test shows Peak Extraction Rate (ml/sec) for several thrombus aspiration catheters. The peak extraction rate ranged from 0.94 ml/second to 1.71 ml/second (Table 3). Published in “Comparison of Dimensions and Aspiration Rate of the Pronto® V3, Pronto® LP, Export® XT, Export® AP, Fetch®, Xtract™, Diver C.E.™ and QuickCat™ Catheters” (
ML1623 Rev. F 12/09 c2009 Vascular Solutions, Inc.) In comparison, theprototype thrombectomy system 100 tested in the two conditions of Table 1, demonstrated an average extraction rate of 3.6 ml/second to 4.0 ml/second, 2.1 to 2.3 times the peak extraction rate of the highest performing catheter (Pronto V3) in the published data set. And it should be mentioned that the designs of the thrombus aspiration catheters of the Table 3 test data are such that there is no guidewire within their lumen (as inFIG. 3 ) during aspiration, and theprototype thrombectomy system 100 tested also did not have a guidewire within its lumens during testing (as inFIG. 4 ). In use, for aspirating body fluids and materials such as blood and thrombus, embodiments of thethrombectomy system 100 of the present disclosure have significantly higher potential to remove thrombus more quickly and more completely than astandard thrombectomy catheter 140, such as those represented in the published data. The amount of vacuum present at thelumen 130 at thedistal end 116 of thedistal tube 114 may be up to twice that (or more) of the amount of vacuum present at the distal tip of thelumen 138 of astandard thrombectomy catheter 140, which attests to larger forces pulling thethrombus 104 into thelumen 130. -
TABLE 3 Peak Extraction Rate (ml/sec) of water System evacuated by 30 ml syringe Pronto ® V3 (Vascular Solutions, Inc.) 1.71 Pronto ® LP (Vascular Solutions, Inc.) 0.94 Export ® XT (Medtronic, Inc.) 1.27 Export ® AP (Medtronic, Inc.) 1.44 Fetch ® (Medrad/Possis) 1.55 Xtract ™ (Volcano/Lumen Biomedical) 1.24 Diver C.E. ™ (Invatec) 1.04 QuickCat ™ (Spectranetics) 1.11 -
FIG. 15A illustrates an embodiment of thethrombectomy system 100, wherein thethrombectomy catheter 106 includes a sealingmember 124 that is an o-ring 174 having a custom cross-section having awider base portion 170 having a width W and awiper blade portion 172 having a width w, that is smaller than width W. Though the maximum outer diameter of the o-ring 174 of this embodiment should be larger than the inner diameter of theinner lumen 110 of the guidingcatheters 108 with which it is compatible (for sealable coupling), the thinner the width w of the wiper blade portion, the less drag and the greater feel is achieved. Thedistal tube 114 includes anannular groove 180, having a width large enough to seat thebase portion 170 of the o-ring 174. InFIG. 15A , thedistal tube 114 of thethrombectomy catheter 106 is shown with adistal skive 158, but without a proximal skive (160 inFIG. 12 ). As mentioned, numerous combinations of theskives FIG. 15B illustrates a closeup of an embodiment of thethrombectomy system 100, wherein thethrombectomy catheter 106 includes a sealingmember 124 that is an o-ring 174 having anx-shaped cross-section 178.FIG. 15C illustrates a closeup of an embodiment of thethrombectomy system 100, wherein thethrombectomy catheter 106 includes a sealingmember 124 that is an o-ring 174 having acircular cross-section 176. Numerous other o-ring cross-sections are contemplated. Theannular groove 180 has enough width to seat the corresponding o-ring cross-sections FIGS. 15B and 15C . A lip, such as thedistally facing lip 166 of the embodiment of thethrombectomy system 100 ofFIG. 11 , or a seal, such as the o-ring 174 having awiper blade portion 172 ofFIG. 15A , may have several optional embodiments in which their maximum outer diameter is constructed to different diameters in relation to the inner diameter of the guidingcatheter 108. For example, in some embodiments, the outer diameter may be in rubbing relation to the inner diameter of the guidingcatheter 108. In some embodiments, the outer diameter may be in touching relation to the inner diameter of the guidingcatheter 108. In some embodiments, the outer diameter may be in close clearance relation to the inner diameter of the guidingcatheter 108. In some embodiments, the outer diameter may be in a non-touching relation to the inner diameter (inner wall 168) of the guidingcatheter 108. In some embodiments, there may me multiple features, having a combination of these relationships (rubbing, touching, etc.). In some embodiments, the sealingmember 124 may be an inflatable balloon, whose diameter and/or inflation pressure may be controlled. - An
alternative thrombectomy system 105 is illustrated inFIGS. 16-17 and comprises anaspiration catheter 111. Theaspiration catheter 111 includes adistal tube 107 coupled to asupport member 109. Theaspiration catheter 111 is configured to be placed through a guiding catheter or any elongate tubular member, with thesupport member 109 extending proximally from the guiding catheter such that thesupport member 109 may be grasped and manipulated by a user, to move theaspiration catheter 111. Anannular seal 103 is configured to provide a liquid seal between thedistal tube 107 of theaspiration catheter 111 and an internal wall in the lumen of a guiding catheter, such as theinner wall 168 of the guidingcatheter 108 inFIG. 15A . In the embodiment ofFIGS. 16-17 , theannular seal 103 comprises an o-ring 113 which is carried on anexternal surface 115 of thedistal tube 107 of theaspiration catheter 111. In some embodiments, the o-ring 113 has an initial unstressed inner diameter which is less than an outer diameter of thedistal tube 107. The o-ring 113 comprises an elastic material, and thus, the o-ring 113 is distended and placed over theexternal surface 115 of thedistal tube 107. The o-ring 113 is thus carried by thedistal tube 107 in a stressed state which forms a seal between the o-ring 113 and theexternal surface 115 of thedistal tube 107. The o-ring 113 may additionally be secured to theexternal surface 115 of thedistal tube 107 so that it cannot be significantly moved longitudinally in relation to thedistal tube 107, for example, with adhesive or epoxy, or bookended between two separate lengths of shrink tubing that is shrunk over thedistal tube 107. In some embodiments, the o-ring 113 in its distended state may add between about 0.003 inches (0.076 mm) to about 0.008 inches (0.203 mm) over the outer diameter of thedistal tube 107. In some embodiments, anelastomeric coating 117 may be applied over the o-ring 113 and theexternal surface 115 of thedistal tube 107. Theelastomeric coating 117 may comprise a dip coating, such as a dip-coatable polyurethane, and may be applied to cover theexternal surface 115 at afirst side 119 adjacent the o-ring 113, and to asecond side 121 adjacent the o-ring 113. The elastomeric coating may have a thickness td of 0.001 inches (0.025 mm) or less, or about 0.0007 inches (0.018 mm), thus increasing the diameter over theexternal surface 115 or the outer diameter of the o-ring 113 by 0.002 inches (0.051 mm) or less, or by about 0.0014 inches (0.036 mm). In some embodiments, thedistal tube 107 has an outer diameter of between about 0.065 inches (1.65 mm) and about 0.069 inches (1.75 mm), or about 0.067 inches (1.70 mm). In some embodiments, the addition of both the o-ring 113 and theelastomeric coating 117, creates anannular seal 103 having an unstressed (uncompressed) outer diameter of between about 0.070 inches (1.78 mm) and about 0.074 inches (1.88 mm), or about 0.072 inches (1.83 mm). These particular embodiments may be appropriate for applications in the coronary arteries. Further embodiments are contemplated that are appropriate for other portions of the vascular anatomy, including blood vessels that on the average are larger or even smaller than the coronary blood vessels. The dimensions of the components described (o-ring 113,elastomeric coating 117, etc.) may be scaled accordingly. The range of catheter sizes may include catheter diameters of between about 2 French and about 12 French. - The
elastomeric coating 117 may be applied to thedistal tube 107 and o-ring 113 by dip coating in some embodiments, prior to the attachment of thesupport member 109 to thedistal tube 107. For example, a mandrel may be placed within thelumen 125 of thedistal tube 107 to support the structure of thedistal tube 107 and the preclude the dip coating material from being applied to aninner surface 127 of thelumen 125 of thedistal tube 107. Theproximal end 129 of thedistal tube 107 may then be dipped into the dip coating material up to a depth dd. The dippeddistal tube 107 and o-ring 113 may then be removed from the container of dip coating material so that a relatively thin layer of theelastomeric coating 117 may be allowed to form. In some embodiments, a two-part mixture is formed to initiate polymerization of the finalelastomeric coating 117. In other embodiments, a polymer may be dissolved or within a solvent, so that the solvent may evaporate from the material to form theelastomeric coating 117. Theelastomeric coating 117 serves to adhere to thedistal tube 107 on either end of the o-ring 113, and to secure the o-ring 113 to the distal tube. Suitable o-ring 113 materials include EPDM, silicone, Buna-N. Suitableelastomeric coatings 117 include polyurethane, santoprene. A significantly large range of durometers may be chosen for both the o-ring 113 and theelastomeric coating 117. In some embodiments, the o-ring 113 may even be a substantially non-elastomeric material, as theelastomeric coating 117 may be configured to provide sufficient compliance and/or elasticity. After theelastomeric coating 117 cures, forms or solidifies, the mandrel may be removed, and thesupport member 109 secured to thedistal tube 107. In some embodiments, a mandrel having a non-circular cross-section may be configured to be placed in thelumen 125 after thesupport member 109 has already been secured to thedistal tube 107, so that theelastomeric coating 117 may be subsequently applied without dip coating material being applied to aninner surface 127 of thelumen 125 of thedistal tube 107. The depth dd may vary from between 0.150 inches (0.38 cm) and the entire length of thedistal tube 107, which may be between about 2 cm and about 20 cm. Anannular seal 103 that comprises both the o-ring 113 and theelastomeric coating 117 has a more gradual change in outer diameter than anannular seal 103 comprising only the o-ring 113. A firstdiametric transition 131 and a seconddiametric transition 133 are shown inFIG. 16 , and can allow smooth longitudinal motion during engagement of theannular seal 103 with theinner wall 168 of the guiding catheter 108 (FIG. 15A ). In addition, theelastomeric coating 117 maintains the o-ring 113 securely on theexternal surface 115 of thedistal tube 107, and has good adherence to theexternal surface 115 because of a relatively large cylindrical adhesion or engagement area over the length equal to the dipping depth dd. In some embodiments, theelastomeric coating 117 may be instead replaced by a shrink tube that is shrunk over the o-ring and at least a portion of theexternal surface 115 of thedistal tube 107. The shrink tubing may comprise relatively low durometer PEBAX® shrink tubing. - In one embodiment, an aspiration system for removal of material from a lumen, cavity or duct of a patient includes an aspiration catheter having a proximal end and a distal end and configured to be inserted through a lumen of an elongate tubular member, the elongate tubular member configured for insertion into the vasculature of a subject and having a proximal end, a distal end, the lumen extending from the proximal end to the distal end, and an inner surface defined by the lumen, the aspiration catheter including a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of the elongate tubular member at the distal end of the elongate tubular member and into the vasculature of the subject; an elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member; and an annular seal carried by the tubular aspiration member and configured to create a liquid seal against the inner surface of the elongate tubular member, wherein the annular seal comprises an o-ring. In some embodiments the o-ring has an unstressed inner diameter and is carried by an external portion of the tubular aspiration member having an external diameter, and wherein the unstressed inner diameter of the o-ring is less than the external diameter of the external portion of the tubular aspiration member. In some embodiments, the annular seal further comprises an elastomeric coating covering an external portion of the o-ring and an external portion of the tubular aspiration member adjacent the o-ring. In some embodiments, the elastomeric coating comprises polyurethane. In some embodiments, the elastomeric coating is a dip coating. In some embodiments, the elastomeric coating has a thickness of less than 0.001 inches (0.025 mm). In some embodiments, the elongate support member comprises a metallic material. In some embodiments, the elongate support member comprises a hypo tube. In some embodiments, wherein the inner surface of the elongate tubular member is located adjacent the distal end of the elongate tubular member. In some embodiments, the elastomeric coating has a longitudinal length that is less than the longitudinal length of the tubular aspiration member.
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FIG. 18 illustrates an embodiment of athrombectomy system 100 having multiple sealingmembers 124, denoted by 124 a, 124 b, 124 c, 124 d, 124 e, and 124 f. In some embodiments, the sealingmembers 124 a-f may be annular seals, such as any of the embodiments described herein. In some embodiments, the guidingcatheter 108 may be from a different or unknown supplier and it may be difficult to know the true inner diameter of theinner lumen 110 along a significant length of the distal portion of the guidingcatheter 108. However, it may be possible for the user to measure the inner diameter at adistal portion 182 of the guiding catheter 108 (for example, using sterile pin or plug gauges). Themultiple sealing members 124 a-f make it possible to adjust the distance DE that theinner tube 114 extends from the guidingcatheter 108, while assuring a sealing relationship between the particular sealingmember 124 a-f and the inner diameter of the guidingcatheter 108 at thedistal portion 182. For example, when sealing member 124 a is sealingly engaged with the inner diameter of the guidingcatheter 108 at thedistal portion 182, DE is much shorter than when sealingmember 124 f is sealingly engaged with the inner diameter of the guidingcatheter 108 at thedistal portion 182. Thus, in use by the physician, thedistal end 116 of thedistal tube 114 can be brought into ideal position in relation to the thrombus 104 (FIGS. 1 and 2 ), for example, just proximal to thethrombus 104. Additionally, the short axial length of contact of each of the sealingmembers 124 a-f with theinner wall 168 of the guidingcatheter 108 summed together is much less than if the entire outercylindrical surface 122 of thedistal tube 114 were a cylindrical seal, and this lowers the drag and increases the feel. Multiple axial spaces 184 a-e, located between the sealingmembers 124 a-f, represent the majority of the length of thedistal tube 114, and thus gap G can be large enough (e.g. 0.0076 cm (0.003 inches) or greater per side) so that even in tortuosities of theblood vessel 102, where the catheters may be curved or angled, the drag is not unacceptably increased and the feel is not unacceptably decreased. -
FIG. 19 illustrates an embodiment of athrombectomy system 100 having one ormore sealing members 124 comprising ahydrogel 186 annularly attached around the outercylindrical surface 122 of thedistal tube 114 of thethrombectomy catheter 106. In some embodiments, the maximum outer diameter of the sealingmember 124 comprising ahydrogel 186 may be less than the inner diameter of theinner lumen 110 of the guiding catheter when the hydrogel is in a non-hydrated or substantially non-hydrated state. The maximum outer diameter of the sealingmember 124 comprising ahydrogel 186 may become greater than the inner diameter of theinner lumen 110 of the guiding catheter when the hydrogel is in a partially hydrated, substantially hydrated, or fully hydrated state. This feature allows thethrombectomy catheter 106 to be advanced with little drag down the guidingcatheter 108 while the sealingmember 124 comprising ahydrogel 186 is becoming hydrated. As the sealingmember 124 comprising ahydrogel 186 becomes substantially hydrated, the sealingmember 124 will likely be already placed at the location of choice in relation to thedistal end 120 of the guidingcatheter 108. In this position, the larger maximum outer diameter of the sealingmember 124 will seal against theinner wall 168 of theinner lumen 110 of the guiding catheter. In some embodiments, thehydrogel 186 has high lubricity in order to allow movement with minimal drag while the sealingmember 124 is in sealing relationship against theinner wall 168 of theinner lumen 110 of the guiding catheter. In some embodiments, the high lubricity is achieved by the hydrogel having a higher water holding capacity. In some embodiments, thehydrogel 186 has relatively lower lubricity in order to minimize accidental axial movement of the sealingmember 124 in relation to the guiding catheter. In some embodiments, the high lubricity is achieved by the hydrogel having a lower water holding capacity. In some embodiments, the hydrogel comprises p-HEMA. -
FIG. 20 illustrates an embodiment of athrombectomy system 100 having one ormore sealing members 124 coupled to theproximal end 118 of thedistal tube 114 of thethrombectomy catheter 106. In some embodiments, the one ormore sealing member 124 is secured to the outercylindrical surface 122 of thedistal tube 114. In some embodiments, the sealingmember 124 is a cone-shaped or bowl-shapedmembrane 190 configured to seal against theinner wall 168 of the guidingcatheter 108 at the wipeend 188. -
FIG. 21 illustrates an embodiment of athrombectomy system 100 having a sealingmember 124 which is formed from theproximal end 118 of thedistal tube 114 of thethrombectomy catheter 106. In some embodiments, the sealingmember 124 is formed by flaring theproximal end 118 of thedistal tube 114, so that aseal ring 192 is created, for sealing against theinner wall 168 of the guidingcatheter 108. -
FIG. 22 illustrates an embodiment of athrombectomy system 100 having a sealingmember 124 coupled to theproximal end 118 of thedistal tube 114 of thethrombectomy catheter 106. In some embodiments, the sealingmember 124 may comprise a cone-shaped or bowl-shapedstructure 194. In some embodiments, thestructure 194 may be formed from atubular braid 196. In some embodiments, thetubular braid 196 may be braided from metallic wires. In some embodiments, thetubular braid 196 may be braided from Nickel-Titanium wires. In some embodiments, thetubular braid 196 may be heat set into a cone shape or a bowl shape. In some embodiments, thetubular braid 196 may be dip coated. In some embodiments, thetubular braid 196 may be dip coated after having been heat set. In some embodiments, thetubular braid 196 may be dip coated with polyurethane. In some embodiments, thetubular braid 196 may be dip coated with silicone. In some embodiments, the dip coating material may form aseal ring 198 for sealing against theinner wall 168 of the guidingcatheter 108. In some embodiments, thetubular braid 196 is formed so that theseal ring 198 is forced against theinner wall 168 of the guidingcatheter 108. In some embodiments, the dip-coated, formedtubular braid 196 is sufficiently compressible that it can be pushed through theinner lumen 110 of a guidingcatheter 108.FIGS. 20-22 illustrate embodiments of athrombectomy catheter 106 in a condition when it is at least partially extended axially out of theinner lumen 110 of the guidingcatheter 108. In some embodiments, a stiffness transition member 197 (FIG. 22 ) may be incorporated into thedistal tube 114. In some embodiments, thestiffness transition member 197 may comprise a hypo tube that is spiral cut (e.g. laser cut) with decreasing pitch moving distally. Other cut patterns may be used, such as a series of partial circumferential cuts, or a zig-zag cut. A number of other methods known in the art may be used to create a transition in stiffness, such as use of composite materials, a transition of polymeric materials, or transitioning braids or coils. -
FIG. 23 illustrates an embodiment of athrombectomy system 100 having a sealingmember 124 which is theproximal end 118 of thedistal tube 114 of thethrombectomy catheter 106. In some embodiments, the entiredistal tube 114 comprises a windsock-like-member 200 having a taperedportion 204. Theproximal end 118 has an increased diameter and is supported radially by astent section 202. In some embodiments, thestent section 202 is a coil. In some embodiments, thestent section 202 is a laser machined metal tube. In some embodiments, thestent section 202 is a tubular braid. -
FIG. 24 illustrates an embodiment of athrombectomy system 100 having a sealingmember 124 which is coupled to theproximal end 118 of thedistal tube 114 of thethrombectomy catheter 106. Astructure 206 comprising two or more fingers 208 a-d is secured to theproximal end 118 of thedistal tube 114. In some embodiments, thestructure 206 is welded or secured using other methods to thesupport member 126. In some embodiments, thestructure 206 is flared outwardly towards the proximal end, leading to asealing ring 212. In some embodiments, thestructure 206 includes a covering 210 over the fingers 208 a-d. In some embodiments, the covering 210 is a membrane. -
FIG. 25 illustrates an embodiment of athrombectomy system 100 of the present disclosure being used in conjunction with the deployment of astent 214. In the method for performing this procedure with thethrombectomy system 100, the interventionalist (physician) places a guidingcatheter 108 into theblood vessel 102. For example, the interventionalist may place thedistal end 120 of the guidingcatheter 108 into the ostium of a coronary artery. The interventionalist may next place aguidewire 134 across anatherosclerotic lesion 218, which may or may not havethrombus 104. The interventionalist next tracks an embodiment of thethrombectomy catheter 106 of the present disclosure over theguidewire 134 and through the guidingcatheter 108, until thedistal end 116 of thedistal tube 114 exits the guiding catheter. The interventionalist the tracks thedistal end 116 of the distal tube to atarget area 112, for example, just proximal to the location of theatherosclerotic lesion 218. The sealingmember 124 is positioned within the guidingcatheter 108, so that it will be sealingly coupled to the guiding catheter at least while aspiration is being performed. The interventionalist then tracks adilatation catheter 216 over theguidewire 134, through the guidingcatheter 108, and across theatherosclerotic lesion 218. The vacuum source 146 (FIGS. 1 and 2 ) is coupled to theside port 152 of the y-connector 148, and thestent 214 is expanded by the dilatation balloon of thedilatation catheter 216 while the thrombectomy system performs aspiration. This lowers the possibility that residual thrombus (clot) is carried downstream, causing potential complications. It also lowers then possibility that residual thrombus remains trapped between thestent 214 and the now dilatedatherosclerotic lesion 218. When the interventionalist deems the result satisfactory, the interventionalist takes final fluoroscopic (or other) images, and then removes the devices. -
FIGS. 26A-26B illustrate an attachment joint 228 and method for joining/coupling thesupport member 126 to the distal tube of athrombectomy catheter 106 according to an embodiment of the present disclosure. A tapered half-pipe member 220 comprising a partial cylinder is secured at itslarge end 222 to theproximal end 118 of thedistal tube 114 by adhesive, epoxy, welding, soldering, embedding or other attachment methods. Thesmall end 224 of the tapered half-pipe member 220 is secured to thesupport member 126 by adhesive, epoxy, welding, soldering, embedding or other attachment methods. Though theskives FIG. 26 , they are compatible with this joining embodiment and method. The tapered half-pipe member 220 allows for a gradual transition that provides anopen area 226, so that flow is not compromised. In some embodiments, theouter radius 227 of the taperedhalf pipe member 220 is configured to substantially match the inner diameter of thedistal tube 114. In some embodiment, theinner radius 229 of the taperedhalf pipe member 220 is configured to substantially match the outer diameter of thedistal tube 114. These embodiments enable a close fit and thus a relatively low profile. -
FIG. 27 illustrates a dipping process for an attachment joint including but not limited to theattachment joint 228 ofFIG. 26 . After the attachment joint 228 is assembled, afirst dipping step 230 is performed over the majority of the length of thedistal tube 114. In some embodiments, thedistal tube 114 may comprise a lubricious inner tube layer, such as PTFE, and a spring coil inner layer around the PTFE inner tube layer. In some embodiments, a medium durometer dipping material, such as polyurethane or PEBAX, is applied to the distal tube. In some embodiments, the medium durometer material may have a durometer of about 63 D. Asecond dipping step 232 is performed with a low durometer material, such as polyurethane of PEBAX, to form a “Soft”tip 234. In some embodiments, the low durometer material may have a durometer of about 55 D. Athird dipping step 236 is performed with a high durometer material over the attachment joint 228. In some embodiments, thethird dipping step 236 is performed over most or all of the length of thesupport member 126. In some embodiments, the high durometer material may have a durometer of about 72 D. The result is a stiff,pushable catheter 106 that has a smooth transition at the attachment joint 228, a flexibledistal tube 114 for tracking through the blood vessel 102 (FIGS. 1, 2 and 25 ) and asoft tip 234 for atraumatic characteristics within theblood vessel 102. A maximizedlumen 130 cross-section area may be achieved in any of the embodiments resented herein by minimizing wall thickness and/or minimizing the thickness of any coating. Ultra-thin wall hypo tubes or polyimide tubes may be used in some embodiments. A dip coating of less than about 0.005 cm (0.002 inches) may be applied, and may include polyurethane. A dip coating of less than about 0.0025 cm (0.001 inches), or about 0.0018 cm (0.0007 inches) may be applied, and may include polyurethane. -
FIG. 28 illustrates an embodiment of athrombectomy catheter 106 of thethrombectomy system 100 having a sealingmember 124 that is radially compressed over acompressible section 242 of thedistal tube 114 during delivery through the guiding catheter 108 (FIG. 1 ). Thecompressible section 242 is held in a compressed state by adelivery sheath 238. In some embodiments, thedelivery sheath 238 has a sheath push and pullrod 240 coupled to a portion thereof. In use, thethrombectomy catheter 106 is delivered through the guidingcatheter 102 and into theblood vessel 102 by pushing thesupport member 126 and/or the sheath push and pullrod 240. When thedistal end 116 of thedistal tube 114 of thethrombectomy catheter 106 is located adjacent thetarget area 112 and theproximal end 118 of thedistal tube 114 is within theinner lumen 110 of the guiding catheter 108 (FIG. 2 ), traction (tension) is applied on the sheath push and pullrod 240 while compression is applied on thesupport member 126, thus causing thedelivery sheath 238 to be pulled proximally, and removed from thecompressible section 242 of thedistal tube 114, thus allowing thecompressible section 242 to expand, and seal against the inner wall 168 (FIG. 15A ) of the guidingcatheter 108. In some embodiments, thedelivery sheath 238 may be retracted completely and removed completely from the guidingcatheter 108. Though aguidewire 134 is not depicted inFIG. 28 , this embodiment, like the other embodiments, may be used with aguidewire 134, as known in the art. In some embodiments, thesupport member 126 may be coupled to thedistal tube 114 via aring 244. In some embodiments, thering 244 may be closer to thedistal end 116 of thedistal tube 114 than theproximal end 118. -
FIG. 29 illustrates athrombectomy system 300 which incorporates the high pressure injection of a liquid, for example sterile saline solution, in order to macerate and aspirate thrombus 104 (FIG. 1 ). A guidingcatheter 108 and a y-connector 148 having aproximal seal 150 and asideport 152 are coupled to avacuum source 146, as described in relation to the prior embodiments. Athrombectomy catheter 306 comprises adistal tube 314 having adistal end 316 and aproximal end 318, theproximal end 318 incorporating one ormore sealing members 324 for sealing off anannulus 342 between the guidingcatheter 108 and thedistal tube 114, as described in relation to the prior embodiments. Thedistal tube 314 has anaspiration lumen 330. A support/supply tube 368, having alumen 370, is coupled to thedistal tube 314. The support/supply tube 368 serves the same purpose as thesupport member 126 of the prior embodiments, but is also a conduit (via the lumen 370) for high pressure saline, which is injected from theproximal end 372 to thedistal end 374. The saline is supplied from a saline source 376 (e.g. saline bag, bottle) and pressurized by apump 378, through asupply tube 380 and through a luer connector 382 which is connected to aluer hub 384 coupled to the support/supply tube 368. In some embodiments, the support/supply tube 368 comprises a hypo tube. In some embodiments, the support/supply tube 368 comprises stainless steel or nitinol. - Turning to
FIGS. 30-32 , in some embodiments, the support/supply tube 368 may be coupled to thedistal tube 314 byattachment materials supply tube 368 has a closeddistal end 394, and has one ormore orifices 390 in itswall 392. In some embodiments, arapid exchange tube 398 having aguidewire lumen 396 and adistal tip 408 may be coupled to the side of thedistal tube 314, as seen inFIGS. 30 and 31 , although the embodiment ofFIG. 29 is shown with theguidewire 134 extending through theaspiration lumen 330 and theinner lumen 110. - After the user tracks the
thrombectomy catheter 306 through the guidingcatheter 108 and to thetarget area 112 in theblood vessel 102, thepump 378 is operated to inject high pressure saline through the support/supply tube 368. When the saline reaches the orifice (arrows 400), the saline is forced through the one ormore orifices 390 and into theaspiration lumen 330. In some embodiments, the saline forms one ormore jets 402 that impinge upon ininner wall 404 of theaspiration lumen 330, adjacent the one or more orifices 390. A high pressure is thus created in theaspiration lumen 330 adjacent theskive 358, forcingthrombus 104 into theaspiration lumen 330 in a direction generally shown byarrow 406. Thethrombus 104 is then carried by the positive pressure gradient from distal to proximal from theaspiration lumen 330 into theinner lumen 110 of the guidingcatheter 108 and out thesideport 152 of the y-connector 148 towards thevacuum source 146. In some embodiments, the one ormore jets 402 serve to break up and macerate thethrombus 104, aiding in its subsequent passage through thelumens thrombus 104 serves to lower its bulk viscosity, and thus aid in its passage through the catheter lumens with less resistance. In some embodiments, the one ormore orifices 390 are located a distance D from the mostproximal portion 410 of adistal opening 412 formed in theaspiration lumen 330 by theskive 358. In some embodiments, the distance D between the axial center of anorifice 390 and the mostproximal portion 410 of thedistal opening 412 is about 0.0508 cm (0.020 inches), or in some embodiments is 0.0508 cm±0.0076 cm (0.020 inches±0.003 inches). -
FIGS. 33-34B illustrate an alternative embodiment of the support/supply tube 368, wherein the support/supply tube 368 couples to thedistal tube 314 at theproximal end 318 of thedistal tube 314. Thedistal tube 314 includes awall 416 having alumen 414. The support/supply tube 368 is coupled to thelumen 414 so that saline supplied through the support/supply tube 368 then passes through thelumen 414 distally, and exits the one or more orifices 390. In some embodiments, thelumen 414 may be provided by a separate polyimide tube that is embedded in thewall 416. In some embodiments, aproximally facing lip 246, for example, an annular seal extending in both a radial and proximal direction, is sealingly coupled to thedistal tube 314. The high pressure saline injection through thelumen 370 of the support/supply tube 368, in combination with the vacuum source 146 (FIGS. 3-6 ), causes aspiration in a direction generally shown byarrow 406. The high pressure saline injection also creates an internal pressure P1 within theinner lumen 110 of the guidingcatheter 108 that is higher than the ambient pressure PA outside thedistal end 120 of the guidingcatheter 108. Because P1>PA, theproximally facing lip 246 is forced against theinner wall 168 of theinner lumen 110 of the guidingcatheter 108, sealing theannulus 142. In some embodiments, theproximally facing lip 246 is thin and made from a flexible material (as in thedistally facing lip 166 ofFIG. 11 ), thus aiding is ability to be forced against theinner wall 168. In some embodiments, other embodiments of the sealingmember 124 may be used, including, but not limited to, o-rings and hydrogel seals. In some embodiments, as seen inFIG. 34B , the distal end of the support/supply tube 368 may have an oval, elliptical or rectangular shape in order to allow a connection to thelumen 414 of thedistal tube 314 that does not significantly compromise the size of theaspiration lumen 330 of thedistal tube 314. -
FIG. 71 is an alternate embodiment of athrombectomy catheter 306 with the support/supply tube 368 ofFIG. 33 having a full distal curve 369 that reverses itself, such that theorifice 390A causes fluid to exit in a reverse direction. In some cases, the full distal curve may be approximately 180°. The full distal curve 369 is a continuous curve that gradually changes the direction of fluid that is flowing through thelumen 370 of the support/supply tube 368. “Direction of fluid” is defined as the direction that the majority of the fluid generally travels. In some embodiments, the reverse direction of exit is along the longitudinal axis in a proximal direction, as generally shown inFIG. 71 . The saline ejected from theorifice 390A may push and lubricate thrombus that is sucked into thedistal tube 314, thus maintaining continued aspiration.FIG. 72 is an alternate embodiment of the support/supply tube 368 ofFIG. 33 having an approximately 90°curve 371 that has anorifice 390B pointing towards theinner wall 391 of thedistal tube 314. In a further alternate embodiment illustrated inFIG. 73 , acurve 373 in the support/supply tube 368 is between about 90° and about 180°. In actuality, an angle anywhere between 90° and 180°, even including 90° or 180°, may be chosen. The angle of theparticular curve 373 inFIG. 73 is between 120° and 150°, or about 135°. The saline ejected from theorifice 390B may macerate the thrombus against theinner wall 391 of thedistal tube 314, thus maintaining continued aspiration. In some embodiments, theorifice curve 369, 371 may span about one centimeter or about one centimeter or less of longitudinal catheter length. Theproximally facing lip 246, shown in the embodiments ofFIGS. 71 and 72 , may be replaced by other annular seals disclosed herein. For example, theproximally facing lip 246 in the embodiments ofFIGS. 71 and 72 may be replaced by theannual seal 103 ofFIGS. 16-17 . For example,FIG. 73 illustrates anannular seal 103 comprising an o-ring 113 and having anelastomeric coating 117. Theelastomeric coating 117 covering the o-ring 113 forms a firstdiametric transition 131 and a seconddiametric transition 133. -
FIG. 35 illustrates an embodiment of thethrombectomy catheter 306 wherein thelumen 370 of the support/supply tube 368 may be decoupled from the luer hub 384 (FIG. 29 ) so that astylet 418 may be inserted down thelumen 370 in order to impart additional stiffness and pushability. In some embodiments, thestylet 418 comprises stainless steel. In some embodiments, the support/supply tube 368 is a circular cross-section hypo tube and has an outer diameter of about 0.0549 cm (0.0216 inches) and an inner diameter of about 0.0483 cm (0.019 inches). In some embodiments, thestylet 418 has a circular cross-section and has an outer diameter of between about 0.038 cm (0.015 inches) and about 0.0457 cm (0.018 inches). In some embodiments, thestylet 418 may have ahub 420 at its proximal end, in order to aid handling of thestylet 418 during insertion and removal. -
FIG. 36 illustrates an embodiment of thethrombectomy catheter 306 wherein thelumen 370 of the support/supply tube 368 is coupled to asmaller tube 422 within theaspiration lumen 330 of thedistal tube 314. In some embodiments, thesmaller tube 422 is a polyimide tube. In some embodiments, thesmaller tube 422 is a tapered polyimide tube, tapering to a smaller diameter as it extends distally to itsorifice 424. The support/supply tube 368 is also secured to aring 426, which in some embodiments is closer to thedistal end 316 than theproximal end 318 of thedistal tube 314. Thering 426 is also secured to thedistal tube 314. When the user pushes on the support/supply tube 368 at its proximal end, the force that in turn is applied to thering 426 serves to “pull” theproximal end 318 of thedistal tube 314, thus lessening the chances of compressing or deforming it. Theproximal end 318 of thedistal tube 314 includes anexpandable section 430 which may include atubular mesh 428. Thetubular mesh 428 may be encapsulated, for example by dipping in polyurethane of silicone, in order to create a sealedaspiration lumen 330 that extends from thedistal end 316 to theproximal end 318. In some embodiments, thering 426 may be constructed from a metal material, such as stainless steel or nitinol. In some embodiments, thering 426 may include radiopaque material, such as platinum, for visualization on fluoroscopy or x-ray. Thering 426, and its use as the point of application of pushing or pulling, may be incorporated into one of the embodiments of thethrombectomy catheters 106 that do not have high pressure saline injection, but only aspiration. In this case, the support/supply tube 368 need not be a tube or hypo tube, but may also be a solid round wire flat wire. - Because of their use of the
inner lumen 110 of the guidingcatheter 108 as a portion of the extended lumen 128 (FIG. 2 ), any of thethrombectomy systems thrombectomy catheter target area 112 depths. A single model ofthrombectomy catheter blood vessel 102 so that it is adjacent to thetarget area 112, but thevacuum source 146 is still coupled at the same location, on theside port 152 of the y-connector 148. A large range of models (e.g. different lengths) of thethrombectomy catheter thrombectomy catheter 106 and/or a single model ofthrombectomy catheter 306 may satisfy the majority of thrombectomy procedures performed in a particular catheterization laboratory or other health care facility, thus requiring a smaller area of shelf space. - An assembly process for an embodiment of a
thrombectomy catheter 306 is illustrated inFIGS. 37-42 . A slottedmandrel 440 having a longitudinally extendingslot 442 is shown inFIG. 37 .FIG. 38 illustrates a cross-section of the slottedmandrel 440 and several components placed over it during a placement step, in the following radial order:liner tube 444,saline lumen tube 448 having asaline lumen 446, and asupport layer 450. In some embodiments, the orifice may be pre-cut into thesaline lumen tube 448 and may be aligned during the placement step. In some embodiments, theliner tube 444 may comprise PTFE or other fluropolymers. In some embodiments, thesaline lumen tube 448 may comprise a polyimide tube. In some embodiments, thesupport layer 450 may comprise a tubular braid, one or more coils or a laser machined hypo tube. The slottedmandrel 440 with thecomponents composite structure 445 having anouter layer 447. The slottedmandrel 440 is then removed, during a removal step, and the ends of thesaline lumen tube 448 may be cut clean. As seen inFIGS. 39-42 , aradiopaque marker band 452 may be incorporated as part of the assembly by bonding theradiopaque marker band 452 to thesaline lumen tube 448 with an adhesive 454 or epoxy, aligning thesaline lumen tube 448 as inFIG. 42 , and then completing the assembly and the dipping process as described in relation toFIG. 38 . - Clogging of aspiration catheters, for example by large pieces of thrombus, is a common concern for users. Techniques to avoid clogging/choking of material within the catheter often involve rapidly, aggressively advancing the aspiration catheter or gently plucking at edges of a thrombus to insure only small pieces or portions are introduced at a time, pieces which are small enough to not clog or occlude the aspiration lumen. When a device becomes clogged during use, the potential for inadvertent dislodgment of thrombus downstream increases; this is referred to as distal embolism. As aspiration procedures of this type are often used in highly technical emergent settings, early clog detection of the aspiration catheter for the user during aspiration can contribute to the success of the procedure and clinical outcome. Some sources have reported that up to 50% of aspiration catheters used get clogged during use.
- The user may have difficulty determining whether there is a vacuum in the system or not. For example, the user may have difficulty determining whether the vacuum has been applied or not (e.g., the vacuum source has been turned on or off). Additionally, the user may have difficulty determining whether there has been a loss of vacuum in the system, for example because of the syringe (or other vacuum source) being full of fluid or because of a leak in the system. Blood is relatively opaque and can coat the wall of the syringe, thus making it difficult to determine when the syringe becomes full. This makes it difficult to determine whether sufficient vacuum is being applied to the aspiration catheter. The vacuum level may change to an unacceptable level even before the syringe becomes full. Extension tubing or other tubing may also cause a loss in vacuum in the system. Certain tubing kinks may be difficult for a user to see or identify. It is also difficult to determine whether there is an air leak in the system, which can be another cause for a loss of vacuum even before the syringe becomes full of the aspirated fluid.
- During the aspiration of thrombus with an aspiration catheter, it is difficult to identify when thrombus is actively being aspirated or when only blood is being aspirated. Typically, it is desired to not aspirate sizable quantities of normal blood from blood vessels, because of the importance of maintaining normal blood volume and blood pressure. However, when tracking the tip of an aspiration catheter in proximity to a thrombus, it is difficult to know whether the aspiration catheter has actively engaged a thrombus, whether it has aspirated at least a portion of the thrombus, or whether it is not engaged with the thrombus, and is only aspirating blood. Though some aspiration catheters, such as those used in the peripheral blood vessels or in an arterio-venous fistula, may be around 50 cm or even less, the tip of an aspiration catheter may in same cases be more than 90 cm from the hands of the user, or as much as 135 cm from the hands of the user, or in some cases as much as 150 cm, and the particular status of vacuum at the tip of the catheter is often not known by the user. A user may thus be essentially plunging a catheter blindly without significant, usable sensory feedback. The catheter may have an outer diameter up to or even greater than 6 French, and may be as high as 10 French or greater. The increased catheter outer diameter can cause some concern of potential trauma inside a blood vessel. The use of aspiration catheters can therefore be inefficient, and cause more blood removal than desired, causing a user to minimize the length of the therapy and in severe cases necessitating blood transfusion. An increased volume of normal blood being aspirated also means that the vacuum source (e.g. syringe) will fill in a shorter amount of time, thus required more frequent replacement of the vacuum source. Distal embolism may occur if the vacuum pressure is not sufficient, and yet the user is not aware.
- In some cases, a syringe that is completely or mostly full or blood and/or thrombus may continue to be used, though in this state, there is not sufficient pressure to effectively aspirate thrombus or unwanted material, thus causing inefficient use of time, and lengthening the procedure. In some cases, the user may not realize the plunger of the syringe has mistakenly not been pulled back (to evacuate the syringe). In some cases, the syringe itself may be defective, and a proper vacuum may not be achieved, without the user being aware. In some cases, kinked tubing, lines, or catheters may go unnoticed, because of bad visibility in a procedural laboratory, or simply from the extent of concurrent activities being performed. In many cases, the user's eyes are oriented or focused on a monitor, for example a fluoroscopic monitor or other imaging monitor, or a monitor with patient vital data. Though the user may be able to view flow through transparent or partially transparent lumens (such as extension tubing), in dim lighting with intermittent viewing, it is difficult for the user's mind to process flow of an opaque liquid (such as blood/thrombus). Even in good lighting with a focused eye, the movement of fluid through extension tubing may not present an accurate picture of the aspiration status, as the visual flow effect may be delayed in relation to the applied vacuum. More than one medical device personnel may be sharing sensory information with each other to attempt to build a current status in each other's minds of the aspiration procedure. When a user relies on another's interpretation, especially when either are multitasking, a false sense of the status may occur. A syringe attached to the aspiration catheter may cause kinking, for example, if placed on an uneven surface. The distal opening in an aspiration lumen of an aspiration catheter may be prone to aspirating directly against the wall of a blood vessel, thus being temporarily stuck against the vessel wall, and stopping flow throughout the aspiration lumen. In some cases, a vacuum that is too large may be accidentally or inappropriately applied to the aspiration lumen of the aspiration catheter, limiting effectiveness (for example, if it causes the walls surrounding the aspiration lumen to collapse and thus, cut off the significantly decrease the flow through the aspiration lumen). The syringes which are sometimes used as a vacuum source to connect to an aspiration lumen of an aspiration catheter may malfunction, and not be fully actuated/evacuated. But, even when the syringe is functioning correctly, it will tend to fill up at difficult to predict moments, and thus commonly have periods of no applied vacuum. In the cases wherein a portion of clot/thrombus is being aspirated through the aspiration lumen, a significant pressure drop may occur at the current position of the thrombus, and thus, a sufficient vacuum may only exist from the proximal end of the aspiration lumen and distally up to the point of the thrombus. Thus, an insufficient vacuum may exist at the distal end of the aspiration lumen, e.g., at the distal end of the aspiration catheter. The same situation may occur if there is an actual clog at some intermediate point within the aspiration lumen. In either of these conditions, because of the insufficient vacuum at the distal end of the aspiration lumen, there may be a risk of thrombus or emboli being send distally in the vasculature, which may cause occlusion, stroke, pulmonary embolism, or other disorders, depending upon the location of the intervention. With current apparati and techniques, these situations are very difficult to detect when they occur. It has been estimated that in as many as 50% of thrombus aspiration procedures, some sort of failure occurs.
- An
aspiration system 2 is illustrated inFIG. 43 and is configured to allow real time monitoring of catheter aspiration. Theaspiration system 2 comprises anaspiration catheter 4, a vacuum source 6, a valve 8,extension tubing 10, and anaspiration monitoring system 48 including an in-line pressure transducer 12. Theaspiration catheter 4 has aproximal end 14 and adistal end 16 and anaspiration lumen 18 extending from theproximal end 14 to thedistal end 16. Theaspiration lumen 18 may be sized for aspiration of thrombus, and in some embodiments may have an inner diameter of between about 0.38 millimeter (0.015 inches) and about 2.54 millimeters (0.100 inches). Theaspiration catheter 4 includes ahub 20 at its proximal end which may include afemale luer connector 22. Theaspiration lumen 18 at thedistal end 16 of theaspiration catheter 4 may include anangled orifice 24, which aids in the tracking through tortuous or occluded vasculature. In some embodiments, aguidewire lumen 26 is coupled to thedistal end 16 of theaspiration catheter 4, and is configured to track over aguidewire 28. The vacuum source 6 may comprise a syringe, and may be sized between 5 ml and 100 ml, or between 20 ml and 60. The vacuum source 6 may comprise a VacLok® syringe, made by Merit Medical, South Jordan, Utah. The vacuum source 6 may include abarrel 30 andplunger 32, with alock 34 which is configured to retain theplunger 32 in position in relation to thebarrel 30, for example, when theplunger 32 is pulled back in direction D to create a negative pressure (vacuum) inside thebarrel 30. In some embodiments, the vacuum source 6 may comprise any other type of evacuatable reservoir, or may comprise a vacuum pump. The vacuum source 6 is connected to theaspiration lumen 18 of theaspiration catheter 4 via theextension tubing 10 and the valve 8. In some embodiments, the vacuum source 6 may be connected directly to theaspiration lumen 18 of theaspiration catheter 4.Male luer connectors 36 andfemale luer connectors 38 are indicated inFIG. 43 . The valve 8 may be a standard two-way stopcock, as illustrated. - The
pressure transducer 12 of theaspiration monitoring system 48 is configured to be fluidly coupled between the vacuum source 6 and theaspiration catheter 4. InFIG. 44A , theaspiration monitoring system 48 is illustrated as a self-contained device of a first embodiment. Thepressure transducer 12 comprises ahousing 40 having acavity 42 extending between afirst port 44 and asecond port 46. In some embodiments, thefirst port 44 comprises a female luer and thesecond port 46 comprises a male luer. In some embodiments, thefirst port 44 comprises a female luer lock and thesecond port 46 comprises a male luer lock, each of which is attachable to and detachable from a corresponding luer lock of the opposite gender. Thefirst port 44 is configured to be coupled to the vacuum source 6, either directly, or with the valve 8 and/orextension tubing 10 connected in between. Thesecond port 46 is configured to be coupled to theaspiration lumen 18 of theaspiration catheter 4, for example, by coupling thesecond port 46 directly or indirectly to thehub 20 of theaspiration catheter 4. When theaspiration system 2 is used to aspirate body fluids and/or materials, for example blood and/or thrombus, the body fluids and/or materials are aspirated through theaspiration lumen 18 of the aspiration catheter from theangled orifice 24 at thedistal end 16 to thefemale luer connector 22 at theproximal end 14, then pass through thesecond port 46 of thepressure transducer 12 first, through thecavity 42, and then through thefirst port 44. Depending on the amount of amount of vacuum (negative pressure) applied by the vacuum source 6, and the amount of flow resistance and resulting pressure drop along theaspiration system 2, the pressure within thecavity 42 will vary. For example, a more viscous fluid like blood, or a fluid having solid, semi-solid, or gel-like particles or portions, will cause more flow resistance through the relativelysmall aspiration lumen 18 of theaspiration catheter 4 than would water or normal saline solution. Thus the pressure within thecavity 42 of thepressure transducer 12 will decrease (the amount of vacuum will increase) as the flow resistance in theaspiration lumen 18 increases. - For definition purposes, when speaking of the amount of vacuum, a pressure of, for example, −15,000 pascal (−2.18 pounds per square inch, or psi) is a “larger vacuum” than −10,000 pascal (−1.45 psi). Additionally, −15,000 pascal is a “lower pressure” than −10,000 pascal. Furthermore, −15,000 pascal has a larger “absolute vacuum pressure” than does −10,000 pascal, because the absolute value of −15,000 is larger than the absolute value of −10,000. In
FIG. 44A , avacuum sensor 50 is disposed within thecavity 42 of thehousing 40 and is in fluid communication with fluid that passes through thecavity 42. Thevacuum sensor 50 may be a standard pressure sensor or transducer, including a pressure sensor designed primarily for measuring positive pressure. It may use any type of pressure sensing technology known in the art, including MEMS Technology. In some embodiments, thevacuum sensor 50 is configured for highest accuracy and/or precision within the range of pressures between about 0 pascal to about −101,325 pascal (−14.70 psi), or between about −45,000 pascal (−6.53 psi) and about −90,000 pascal (−13.05 psi), or between about −83,737 pascal (−12 psi) and about −96,527 pascal (−14 psi). In some embodiments, the power requirement for the vacuum sensor may range from 2.5 volts DC to 10 volts DC. In some embodiments, thevacuum sensor 50 may be an analog gauge with an output voltage. In the self-contained embodiment of theFIG. 44A , thevacuum sensor 50 is powered by one ormore battery 52. Based on the power requirements of thevacuum sensor 50, and the power requirements of other components of theaspiration monitoring system 48 described herein, in some embodiments the one ormore battery 52 may range between 1.5 volts and nine volts. Also contained within the housing is ameasurement device 54, which in some embodiments may comprise a microprocessor. Themeasurement device 54 is coupled to thevacuum sensor 50 and receives signals from thevacuum sensor 50 indicative of real time measured pressure. In some embodiments, themeasurement device 54 includes amemory module 56 in which information is stored that may be used by themeasurement device 54, for example, in calculations. Information may include, for example, an array of one or more pressure values. In some embodiments, the array of one or more pressure values may be correlated with one or more different corresponding system models or catheter models. Thevacuum sensor 50 may be used in some cases for detecting the presence or amount of vacuum alone, for the purpose of monitoring whether the vacuum source 6 (e.g., syringe) is significantly full, and thus needs to be changed. Thevacuum sensor 50 may be used in some cases for detecting whether there is a vacuum in the system or not. For example, whether the vacuum has been applied or not (e.g., the vacuum source has been turned on or off). - One or
more communication devices aspiration monitoring system 48 and are coupled to themeasurement device 54. Each of the one or more communication devices 58 a-c are configured to generate a type of alert comprising analert signal 60 a-c, in response at least in part to activity and output of themeasurement device 54. In some embodiments, thecommunication device 58 a may include one or more LEDs (light emitting diodes) configured to generate a visible alert via avisible alert signal 60 a, such as light that is continuously illuminated, or is illuminated in a blinking pattern. In some embodiments, the LEDs may be oriented on multiple sides of thecommunication device 58 a, so that they may be easily seen from a variety of different locations. In some embodiments, lights other than LEDs may be used. Light pipes or other lighting conduits may also be incorporated in embodiments, to further place visual indicators at multiple locations and/or orientations. In some embodiments, thecommunication device 58 b may include one or more vibration generators configured to generate a tactile alert via atactile alert signal 60 b, which may include, but is not limited to, vibration or heat. In some embodiments, the vibration device may be similar to a video game controller. In some embodiments, the vibration generator may comprise a piezoelectric device which is configured to vibrate when a voltage is applied. In some embodiments, thecommunication device 58 c may include one or more sound generating devices configured to generate an audible alert via anaudible alert signal 60 c, such as a continuous noise, or a repeating noise. Thecommunication device 58 c in some embodiments may comprise a loudspeaker for generation of any variety of sounds, at any variety of frequencies (Hz) or sound pressures (dB) within the human audible range and/or human tolerance range. Thecommunication device 58 c may even be configured to generate sounds that are outside the human audible range in embodiments wherein the signal is intended to be felt as a vibration or other tactile sensation, instead of an audible sensation. In some embodiments, the sound generating device may comprise a buzzer which is configured to sound one or more audible pitches when a voltage is applied. In some embodiments a piezoelectric device, such as that described in relation to thecommunication device 58 b may also serve as a sound generating device, included ascommunication device 58 c. Thealert signal 60 a-c can at times serve as a “wake up” alarm for the user, in cases where the user has become too focused on other factors during the procedure. A user of anaspiration system 2 may desire to be notified of several conditions which may occur during use of theaspiration system 2. These potential conditions include, but are not limited to clogging, a loss of vacuum due to filling of the vacuum source 6 and or a breach, break or puncture in theaspiration system 2, and the engagement or aspiration of non-fluid, solid or semi-solid material such as thrombus. Theaspiration monitoring system 48 ofFIG. 44A is configured to alert users of anaspiration system 2 about real time status of theaspiration system 2, including operational conditions, which include: whether vacuum is being applied or not; flow conditions, which include whether a thrombus is engaged, whether a thrombus is being actively aspirated, whether the system is leaking air, whether the system is clogged, whether the vacuum source 6 is full and/or needs to be changed; or other potential set up issues. The real time feedback provided frees a user or operator from the need of excessive personal monitoring of the vacuum source 6,extension tubing 10, or other portions of theaspiration system 2, for improper or undesired flow or operation conditions, and thus allows the user to focus more attention on the patient being treated. The user is kept aware of whether a clot is being aspirated or has been aspirated, or whether there is a clog. Additionally, the user is kept aware of whether there is too large an amount of blood being removed from the patient, or whether there are fault conditions like system leak or tubing kink. A tubing kink distal to thevacuum sensor 50 may be identified (for example by an increase in measured vacuum) and a tubing kink proximal to thevacuum sensor 50 may be identified (for example, by a loss or degradation of vacuum). In some cases, the user may attempt to operate the catheter with a vacuum source 6 that is already full (and thus has no significant vacuum). In some cases, a user may even forget to open the valve 8 to begin suction, but the aspiration monitoring system, 48 can also identify that the system is not yet functioning, and communicate a list of potential errors or specific errors (for the particular pressure waveform measured). By having the real-time awareness of the many factors related to the operating status, the procedure is made safer, the time of the procedure may be reduced, and blood loss may be reduced. - The
pressure transducer 12 of theaspiration monitoring system 48 is configured to continuously measure and monitor the absolute pressure amplitude within the closed system of theaspiration system 2, and also is configured to measure and monitor the relative pressure over time to detect noteworthy flow changes within the flow circuit of theaspiration system 2. Some changes are discernible via absolute pressure measurement, while more subtle pressure deflections may be compared to a stored library in memory. Noteworthy conditions may be signaled to the user when appropriate. In some embodiments, the unfiltered signal may be amplified by an amplifier and filtered by a filter, for example, to increase the signal-to-noise ratio. Examples of the (background)noise 57 in an unfiltered signal can be seen inFIGS. 46A-46D (labeled inFIG. 46A ). In some embodiments, one or more algorithms may be used, as described herein, to identify particular conditions of interest. -
FIG. 44B illustrates a second embodiment of anaspiration monitoring system 62 having apressure transducer 12 having avacuum sensor 50 disposed within thecavity 42 of ahousing 40. Thevacuum sensor 50 may be powered by at least onebattery 52. In some embodiments, thepressure transducer 12 may be reusable, and may be configured to allow charging of thebattery 52, or of a capacitor (not shown) by direct charging methods, or by inductive power transfer methods and devices known in the art. Unlike theaspiration monitoring system 48 ofFIG. 44A , theaspiration monitoring system 62 ofFIG. 44B comprises ameasurement device 64,memory module 66, andcommunication device 68 which are external to thepressure transducer 12. Apower module 72, also external, may be used to power any of themeasurement device 64,memory module 66, orcommunication device 68. Thecommunication device 68 may be any of thecommunication device aspiration monitoring system 48 ofFIG. 44A , and are configured to product an alert via analert signal 70. Thecommunication device 68 may be portable so that it may be positioned close to the user. - In some embodiments, the
communication device 68 may be wearable by the user.FIG. 44C illustrates anaspiration monitoring system 78 which includes anantenna 80 coupled to ameasurement device 76. Themeasurement device 76 is similar to themeasurement device 54 of prior embodiments, except that it wirelessly sends acommunication signal 84 via theantenna 80 to a correspondingantenna 82 of acommunication device 74. In some embodiments, thecommunication device 74 comprises a wristband which the user wears, and which may include a vibration generator or heat generator. In some embodiments, thecommunication device 74 comprises an audio speaker which may be attached to equipment or even to the patient or user. In some embodiments, thecommunication device 74 comprises an audio speaker on an earpiece or earbud that the user may wear. In some embodiments, Bluetooth® communication technology may be used. The real time feedback supplied by theaspiration monitoring system 62 may decrease the time that theaspiration system 2 is actively aspirating without being engaged with a thrombus, thus minimizing the amount of nonthrombotic blood lost by aspiration. This may be particularly beneficial in larger bore catheters, for example in catheters having a diameter of 7 French or larger. The real time feedback may also minimize the amount of total time that catheters are tracked back-and-forth through the blood vessels, minimizing potential damage to the intima of the blood vessels, dissection of the blood vessels, or distal embolization. By lowering the risk of the aspiration catheter tip getting caught (via suction) against the blood vessel wall, the distal end of the aspiration lumen may be more aggressively designed for optimized aspiration characteristics. The technique of using the aspiration catheter may additionally be able to be performed in a more sophisticated manner, with continual or continuous knowledge of the vacuum status. For example, a piece of thrombus may be aspirated, followed by a “chaser” of blood aspiration, followed by another piece of thrombus, etc. -
FIG. 45A illustrates thedistal end 16 of anaspiration catheter 4 within ablood vessel 86 having at least onethrombus 88. Theaspiration catheter 4 is being advanced in a forward direction F, but thedistal end 16 of theaspiration catheter 4 has not yet reached theproximal extremity 94 of thethrombus 88. A vacuum source 6 (FIG. 43 ) has been coupled to theaspiration lumen 18 of theaspiration catheter 4 and activated (i.e. the valve 8 is open) causingblood 96 to be aspirated into the aspiration lumen 18 (arrows A). Turning toFIG. 46A , a correspondingcurve 98 is represented for the normal fluid (e.g. blood) vacuum over time for the condition ofFIG. 45A . Thecurve 98 represents vacuum pressure over time sensed by thevacuum sensor 50 of any of the embodiments presented. No leaks are present and no thrombus is being evacuated, and therefore thecurve 98 includes adownward slope 99 when the vacuum source 6 increases the vacuum up (lowers the pressure) within thecavity 42 of thepressure transducer 12 to a relatively steady state. Thesteady pressure curve 97 continues whileblood 96 is being aspirated. As the vacuum is decoupled from theaspiration lumen 18, for example by closing the valve 8 or by detaching any two of the ports (e.g. luers), or if the vacuum source 6 fills completely withblood 96, then anupward slope 95 is measured. - The
measurement device curve 97 with information stored in thememory module measurement device measurement device Communication device 58 a, for example a particular color LED, may be illuminated, or an LED may flash in a particular pattern or number of flashes.Communication device 58 b may create a characteristic sound, or may generate an audio message in a number of languages. For example, the audio message may state, “Thrombus encountered,” or “No thrombus encountered.” A different type of sound may be used for each of a plurality of “modes”: “Thrombus encountered,” “Actively flowing,” “No Vacuum.” For example, a buzzing sound for “Thrombus encountered,” a beep for “No vacuum,” etc. The various characteristics of sound that may be varied include, but are not limited to timbre, or sound quality, spectrum, envelope, duration, phase, pitch (frequency), and number of sounds (repetition).Communication device 58 c may vibrate or heat in a characteristic pattern, for example, a certain number of repetitions or a certain frequency between repetitions. The user may determine that an additional fluoroscopic image (e.g. angiography) or other imaging modalities may be necessary to better identify the location of thethrombus 88. -
FIG. 45B illustrates thedistal end 16 of anaspiration catheter 4 advanced to a position such that thedistal end 16 of theaspiration catheter 4 contacts theproximal extremity 94 of thethrombus 88. The correspondingcurve 93 inFIG. 46B represents vacuum pressure over time sensed by thevacuum sensor 50 of any of the embodiments presented. Thecurve 93 initially has adownward slope 99 followed by asteady pressure curve 97, as in the condition ofFIG. 45A , graphed inFIG. 46A , however, when thedistal end 16 of theaspiration catheter 4 contacts theproximal extremity 94 of thethrombus 88, if the aspiration causes a portion of the thrombus 88 (for example a large or relatively hard portion) to enter and become trapped in theaspiration lumen 18, then a clog condition occurs. A similar condition occurs if thedistal end 16 of theaspiration catheter 4 is caught on thethrombus 88 by the vacuum, with virtually nothing flowing through theaspiration lumen 18. In either condition, thecurve 93 includes a deviation (or disturbance) influid pressure 91. If the clog (or stuck condition) continues, then a flat,depressed pressure 89 is measured. - The
measurement device curve 93 with information stored in thememory module measurement device memory module pressure difference 81 less than this threshold does not result in themeasurement device alert signal 60 a-c, 70. In some embodiments, when thepressure difference 81 is greater than (or greater than or equal to) the pre-set pressure differential ΔP1, themeasurement device Communication device 58 a, for example a particular color LED, may be illuminated, or an LED may flash in a particular pattern or number of flashes.Communication device 58 b may create a characteristic sound, or may generate an audio message in a number of languages. For example, the audio message may state, “Clog Condition.”Communication device 58 c may vibrate or heat in a characteristic pattern, for example, a certain number of repetitions or a certain frequency between repetitions. When the user realizes that the clog condition is present, the user may pull on theaspiration catheter 4 and readvance it, in an attempt to contact a portion of thethrombus 88 that can be aspirated. If a portion of the thrombus is clogged in theaspiration lumen 18, and repositioning of theaspiration catheter 4 does not produce good results, theaspiration catheter 4 can be removed and theaspiration system 2 can be repurged, for example by a positive pressurization. -
FIG. 45C illustrates thedistal end 16 of theaspiration catheter 4 in a general situation during which a breach in theaspiration system 2 has occurred. For example, a break, leak, puncture, pinhole, loosening, or disconnection may cause air to be pulled into theaspiration lumen 18 of theaspiration catheter 4, thecavity 42 of thepressure transducer 12, of the interior of theextension tubing 10, valve 8, or vacuum source 6. As graphed in thecurve 85 ofFIG. 46C , adownward slope 99 and a subsequentsteady pressure curve 97 are measured, but at the point in time of thebreach 87 anupward slope 83 begins. - The
measurement device curve 85 with information stored in thememory module measurement device measurement device Communication device 58 a, for example a particular color LED, may be illuminated, or an LED may flash in a particular pattern or number of flashes.Communication device 58 b may create a characteristic sound, or may generate an audio message in a number of languages. For example, the audio message may state, “System Leak.”Communication device 58 c may vibrate or heat in a characteristic pattern, for example, a certain number of repetitions or a certain frequency between repetitions. Upon receiving the alert, the user will check the components of theaspiration system 2 and either fix the breach or replace one or more of the components of theaspiration system 2. For example, in some cases, the communication device 58 a-c, 74 may alert the user when themeasurement device -
FIG. 45D illustrates thedistal end 16 of theaspiration catheter 4 during the successful aspiration of pieces orportions 90 of thethrombus 88. In some cases, the pieces orportions 90 may follow atortuous path 92, due to disturbances or collisions with the inner wall of theaspiration lumen 18 while being pulled through theaspiration lumen 18. In some cases, the pieces orportions 90 may catch and slip within the inner wall of theaspiration lumen 18, for example, do to variance of the inner diameter of theaspiration lumen 18 along the length. Either of these situations can cause a corresponding series of increases and decreases in the pressure being sensed by thepressure transducer 12, while the pieces orportions 90 are traveling through theaspiration lumen 18. As graphed in thecurve 79 ofFIG. 46D , adownward slope 99 and a subsequentsteady pressure curve 97 are measured, but as the pieces orportions 90 ofthrombus 88 travel down theaspiration lumen 18 of theaspiration catheter 4, adeviation 77 of fluid pressure comprising a one or more decreases and increases in pressure (increases and decreases in vacuum pressure) is measured. As the pieces orportions 90 ofthrombus 88 exit the proximal end of theaspiration lumen 18 of theaspiration catheter 4, a secondsteady pressure curve 75 is measured. Theduration 67 of thedeviation 77 is the amount of transit of the particular significant pieces orportions 90 ofthrombus 88. Theduration 67 can range quite a bit, but in some cases may be less than a second or up to about 30 seconds. A single thrombus being aspirated may cause a single decrease in pressure (a blip) which is identified by themeasurement device portions 90 ofthrombus 88 are aspirated into and travel down theaspiration lumen 18 of theaspiration catheter 4, anotherdeviation 73 of fluid pressure comprising a one or more decreases and increases in pressure (increases and decreases in vacuum pressure) is measured. At the end of thecurve 79, the vacuum source 6 is shown filling completely withblood 96 and the pieces orportions 90 ofthrombus 88, and so anupward slope 95 is measured. - The
measurement device curve 79 with information stored in thememory module portions 90 ofthrombus 88 are actively being aspirated, as indeviation 77 anddeviation 73, and when the pieces or portions ofthrombus 88 are not being actively, or substantially, aspirated, as insteady pressure curve 97, thesteady pressure curve 75, and thesteady pressure curve 71. In some embodiments, themeasurement device memory module pressure difference 69 less than this threshold does not result in themeasurement device alert signal 60 a-c, 70. In some embodiments, when thepressure difference 69 is greater than (or greater than or equal to) the pre-set pressure differential ΔP2, themeasurement device Communication device 58 a, for example a particular color LED, may be illuminated, or an LED may flash in a particular pattern or number of flashes. In some embodiments, thecommunication device 58 a may comprise a light whose intensity increases proportionally with the pressure.Communication device 58 b may create a characteristic sound, or may generate an audio message in a number of languages. For example, the audio message may state, “Thrombus being aspirated.” In some embodiments,communication device 58 b may comprise one or more noises or beeps. In some embodiments, thecommunication device 58 b may comprise a particular series of beeps corresponding to each different condition. For example, three short beeps may correspond to no thrombus being aspirated, while five long, loud beeps may correspond to a system leak. In some embodiments, a plurality of different tones (pitches) may be used to alert a user about different conditions. As an example, a low pitch sound may be used for a first condition (e.g. no thrombus being aspirated) and a second, higher pitch sound may be used for a second condition (e.g. a system leak). In some embodiments, a plurality of different tones may be used to alert a user about a first condition and a second plurality (e.g. in a different combination, or with additional tones) may be used to alert a user about a second condition.Communication device 58 c may vibrate or heat in a characteristic pattern, for example, a certain number of repetitions or a certain frequency between repetitions. When the user realizes that the thrombus is being aspirated, the user may choose to advance (or retract) theaspiration catheter 4, for example with fluoroscopic visualization, along the length of thethrombus 88, in an attempt to continue the aspiration of thethrombus 88. In some cases, the user may choose to stop the advancement or retraction of theaspiration catheter 4 at a certain amount of time after the alert is generated, in order to allow the pieces orportions 90 ofthrombus 88 to completely exit theaspiration lumen 18. When themeasurement device steady pressure curve deviation measurement device alert signal 60 a-c, 70. For example, in some embodiments,communication device 58 b may send an audio message that states, “Thrombus no longer being aspirated.” When the user realizes that the thrombus is no longer being aspirated, the user may advance or retract the aspiration catheter, in an attempt to contact another portion of thethrombus 88 that can be aspirated. In some embodiments, thedeviation 77 may be positively identified as a true deviation indicating thrombus being actively aspirated,pressure difference 69 is between about 700 pascal and about 1700 pascal. In some embodiments, thedeviation 77 may be positively identified as a true deviation indicating thrombus being actively aspirated,pressure difference 69 is between about 1000 pascal and about 1300 pascal. In some embodiments, thedeviation 77 may be positively identified as a true deviation indicating thrombus being actively aspirated,pressure difference 69 is about 1138 pascal. Thepressure difference 69 may be measured by determining abaseline pressure 63 and apeak pressure 61 and determining the absolute value difference. For example: -
Absolute value difference (AVD)=|(−89,631 pascal)−(−90,769 pascal)|=1138 pascal -
Or for example: -
Absolute value difference (AVD)=|(−43,710 pascal)—(−45,102 pascal)|=1281 pascal - The pressure difference 81 (
FIG. 46B ) may also represent a deviation that may be identified in a similar manner, after which the communication device 58 a-c, 74 generates an appropriate alert, such as, “Clog condition.” - Because vacuum pressure is a negative pressure, the
peak pressure 61, as shown inFIG. 46D , is actually a lower number than thebaseline pressure 63. In some embodiments, themeasurement device duration 65 of a single one of the more or more decreases and increases in pressure in thedeviation 77. For example, in some embodiments, the deviation may be positively identified as a true deviation indicating thrombus being actively aspirated, if the duration is between about 0.001 seconds and about 0.50 seconds. In some embodiments, the deviation may be positively identified as a true deviation indicating thrombus being actively aspirated, if the duration is between about 0.005 seconds and about 0.10 seconds. In some embodiments, the deviation may be positively identified as a true deviation indicating thrombus being actively aspirated if the duration is between about 0.05 seconds and about 0.20 seconds. In some embodiments, themeasurement device deviation 77 after two or more decreases and increases in pressure are measured. In some embodiments, themeasurement device deviation 77 after five or more decreases and increases in pressure are measured. In some embodiments, themeasurement device deviation 77 after ten or more decreases and increases in pressure are measured. - The
baseline pressure 63 may in some embodiments be predetermined and may be stored in thememory module baseline pressure 63 may be stored in thememory module aspiration monitoring system baseline pressure 63 may also be input by the user prior to or during a particular procedure. In some embodiments, thebaseline pressure 63 may be determined or otherwise defined by themeasurement device baseline pressure 63 may be constructed as a moving average, such as a running average or rolling average. Several types of moving average may be used, including a simple moving average, a cumulative moving average, a weighted moving average, or an exponential moving average. In any of these cases, a threshold may be determined by themeasurement device determined baseline pressure 63 and a known pressure differential ΔP. In some cases, a pressure differential ΔP may even be calculated by themeasurement device determined baseline pressure 63 and a known threshold. - Insertion of the
pressure transducer 12 in line in either the embodiment ofFIG. 44A or the embodiment ofFIG. 44B does not measurably change performance characteristics of theaspiration system 2, because thecavity 42 is relatively short and has a relatively large inner diameter, and thus is not a significant source of fluid flow resistance. In some embodiments, the inner diameter may be between about 2.2 mm (0.086 inches) and about 3.2 mm (0.125 inches). In some embodiments, themeasurement device FIG. 44B , thepressure transducer 12 may be an off-the-shelf blood pressure monitor system, which is modified or augmented with other components. In some embodiments an off-the-shelf blood pressure monitor system may be used as the output of theaspiration monitoring system aspiration catheter 4 may have a pressure transducer in thedistal end 16. This pressure transducer may be used as thepressure transducer 12 of theaspiration monitoring system aspiration lumen 18. In some embodiments, the pressure sensor may be located anywhere within the aspiration lumen of the aspiration catheter. - In some embodiments, instead of an LED, the visual alert is provided by a
communication device 58 a comprising a display which displays visual messages of text in a particular language, for example, “Thrombus encountered,” “No thrombus encountered,” “Clog condition,” “System leak,” “Loss of vacuum,” “Thrombus being aspirated,” or “Thrombus no longer being aspirated.” The visual messages may be combined with any of the otheralert signals 60 a-c, 70 described herein. Theaspiration monitoring system aspiration system 2. One skilled in the art will recognize that by knowing the real time condition of theaspiration system 2, the user is able to immediately make changes to the procedure in order to optimize results, increase safety for the patient and/or medical personnel, reduce costs (e.g. number of vacuum sources 6 required), and reduce procedure time (also a cost benefit). Because the user is typically performing multiple tasks during an aspiration procedure, the sensory aid provided by theaspiration monitoring system aspiration monitoring system FIG. 44B ), which may comprise a data entry module, keyboard, or a series of buttons with a display. Theinput 59 may in some embodiments comprise an auditory input which accepts voice commands. Alternatively, the user may input information and control the aspiration monitoring system, 48, 62, 78 remotely. Some of the alerts which the user may select or deselect in theaspiration monitoring system aspiration system 2 is potentially blocked or clogged, or is flowing normally; whether thrombus has been contacted or not; whether a clog has occurred; whether the vacuum source 6 is adequate, or whether it has been depleted and requires replacement; whether there is a leak in theaspiration system 2; whether setup or connection of the components of theaspiration system 2 was done correctly or incorrectly; whether to advance the catheter distally; whether to retract the catheter; whether to continue moving the catheter at the same speed; whether to increase or decrease the speed of catheter advancement; whether thrombus is actively being aspirated; and whether thrombus stops being actively aspirated. As the user becomes familiar with theaspiration monitoring system aspiration monitoring system - In some embodiments, alternate power sources may be used, for example, standard AC power with or without an AC/DC convertor; direct connection to existing equipment (e.g. vacuum pumps, etc.); solar power. The
aspiration monitoring system pressure gauge 12, in order to determine, for example, a clog, or a change in the amount of vacuum. In some embodiments, theinput 59,power module 72,measurement device 64,memory module 66, and communication device 64 (e.g., ofFIG. 44B ) may all be incorporated into a single external device, which may in some cases be sold separately. In some embodiments, the external device may also have other functions, such as providing aspiration and/or injection (negative pressure and/or positive pressure) to a catheter. In other embodiments, the external device may comprise some, but not all of theinput 59,power module 72,measurement device 64,memory module 66, andcommunication device 68. For example, in some embodiments, a communication device 58 (FIG. 44A ) may replace theexternal communication device 68, and may be carried on theaspiration monitoring system 48, while theinput 59,power module 72,measurement device 64, memory module 66 (FIG. 44B ) are incorporated into a single external device. A number of combinations are possible, as described in more detail herein. - Though aspiration of thrombus has been described in detail, the
aspiration monitoring system - In some embodiments, the
aspiration system 2 is be provided to the user as a kit with all or several of the components described, while in other embodiments, only theaspiration monitoring system 48 is provided. Though discussion herein includes embodiments for aspiration of thrombus and blood, the definition of the word “fluid” should be understood throughout to comprise liquids and gases. A pressure transducer of an embodiment of the aspiration monitoring system presented herein may be located at a point along the aspiration lumen or any extension of the aspiration lumen (tubes, connectors, etc.). - In some embodiments, an additional or alternate sensor may be used to monitor flow conditions for the notification of the user, including, but not limited to: a Doppler sensor, an infrared sensor, or a laser flow detection device. In some embodiments, an externally-attached Doppler sensor may be employed. In some embodiments, an infrared sensor or a laser flow detection device may be employed around the
extension tubing 10. -
FIG. 52 is a diagrammatic figure depicting an assistedaspiration system 510. Theaspiration system 510 includes aremote hand piece 512 that contains afluid pump 526 and anoperator control interface 506. In one contemplated embodiment, thesystem 510 is a single use disposable unit. Theaspiration system 510 may also includeextension tubing 514, which contains afluid irrigation lumen 502 and anaspiration lumen 504, and which allows independent manipulation of acatheter 516 without requiring repositioning of thehand piece 512 during a procedure performed with theaspiration system 510.Extension tubing 514 may also act as a pressure accumulator. High pressure fluid flow from thepump 526, which may comprise a displacement pump, pulses with each stroke of thepump 526 creating a sinusoidal pressure map with distinct variations between the peaks and valleys of each sine wave.Extension tubing 514 may be matched to thepump 526 to expand and contract in unison with each pump pulse to reduce the variation in pressure caused by the pump pulses to produce a smooth or smoother fluid flow at tip ofcatheter 516. Any tubing having suitable compliance characteristics may be used. Theextension tubing 514 may be permanently attached to thepump 526 or it may be attached to thepump 526 by aconnector 544. Theconnector 544 is preferably configured to ensure that theextension tubing 514 cannot be attached to thepump 526 incorrectly. - An
interface connector 518 joins theextension tubing 514 and thecatheter 516 together. In one contemplated embodiment, theinterface connector 518 may contain afilter assembly 508 between high pressurefluid injection lumen 502 of theextension tubing 514 and a highpressure injection lumen 536 of the catheter 516 (FIG. 54 ). Thecatheter 516 and theextension tubing 514 may be permanently joined by theinterface connector 518. Alternatively, theinterface connector 518 may contain a standardized connection so that a selectedcatheter 516 may be attached to theextension tubing 514. In some embodiments, thefilter assembly 508 may be removably coupled to theextension tubing 514 by a quick disconnect connection. - Attached to the
hand piece 512 are afluid source 520 and avacuum source 522. A standard hospital saline bag may be used asfluid source 520; such bags are readily available to the physician and provide the necessary volume to perform the procedure. Vacuum bottles may provide thevacuum source 522 or thevacuum source 522 may be provided by a syringe, a vacuum pump or other suitable vacuum source. Thefilter assembly 508 serves to filter particulate from thefluid source 520 to avoid clogging of the highpressure injection lumen 536 and an orifice 542 (FIG. 54 ). As described herein, distal sections of the highpressure injection lumen 536 may be configured with small inner diameters, and to thefilter assembly 508 serves to protect their continuing function. By incorporating one of a variety ofcatheters 516 into the assistedaspiration system 510, for example with varying lumen configurations (inner diameter, length, etc.), a variety of aspiration qualities (aspiration rate, jet velocity, jet pressure) may be applied in one or more patients. These aspiration qualities can be further achieved by adjustment of thepump 526, to modify pump characteristics (flow rate, pump pressure). In some embodiments, thecatheter 516 may be used manually, for example, without thepump 526, and controlled by hand injection. The manual use of thecatheter 516 may be appropriate for certain patient conditions, and may serve to reduce the cost of the procedure. - In one contemplated embodiment, the
catheter 516 has a variable stiffness ranging from stiffer at the proximal end to more flexible at the distal end. The variation in the stiffness of thecatheter 516 may be achieved with a single tube with no radial bonds between two adjacent tubing pieces. For example, the shaft of thecatheter 516 may be made from a single length of metal tube that has a spiral cut down the length of the tube to provide shaft flexibility. Variable stiffness may be created by varying the pitch of the spiral cut through different lengths of the metal tube. For example, the pitch of the spiral cut may be greater (where the turns of the spiral cut are closer together) at the distal end of the device to provide greater flexibility. Conversely, the pitch of the spiral cut at the proximal end may be lower (where the turns of the spiral cut are further apart) to provide increased stiffness. A single jacket covers the length of the metal tube to provide for a vacuum tight catheter shaft. Other features ofcatheter 516 are described with reference toFIG. 54 , below. -
FIG. 53 is a diagrammatic view showing more detail of thehand piece 512 and the proximal portion of assistedcatheter aspiration system 510. Thehand piece 512 includes acontrol box 524 where the power and control systems are disposed. Thepump 526 may be a motor driven displacement pump that has a constant output. This pump displacement to catheter volume, along with the location of the orifice 542 (exit) of the catheterhigh pressure lumen 536 within the aspiration lumen 538 (FIG. 54 ), ensures that no energy is transferred to the patient from the saline pump as all pressurized fluid is evacuated by the aspiration lumen. Aprime button 528 is mechanically connected to aprime valve 530. When preparing the device for use, it is advantageous to evacuate all air from the pressurized fluid system to reduce the possibility of air embolization. By depressing theprime button 528, the user connects thefluid source 520 to thevacuum source 522 via thepump 526. This forcefully pulls fluid (for example 0.9% NaCl solution, or “saline”, no “normal saline”, or heparinized saline) through the entire pump system, removing all air and positively priming the system for safe operation. A pressure/vacuum valve 532 is used to turn the vacuum on and off synchronously with the fluid pressure system. One contemplatedvalve 532 is a ported one-way valve. Such a valve is advantageous with respect to manual or electronic valve systems because it acts as a tamper proof safety feature by mechanically and automatically combining the operations of the two primary systems. By having pressure/vacuum valve 532, the possibility of turning the vacuum on without activating the fluid system is eliminated. - The
operator control interface 506 is powered by a power system 548 (such as a battery or an electrical line), and may comprise anelectronic control board 550, which may be operated by a user by use of one ormore switches 552 and one ormore indicator lamps 554. Thecontrol board 550 also monitors and controls several device safety functions, which include over pressure and air bubble detection and vacuum charge. Apressure sensor 564 monitors pressure, and senses the presence of air bubbles. Alternatively, anoptical device 566 may be used to sense air bubbles. In one contemplated embodiment, the pump pressure is proportional to the electric current needed to produce that pressure. Consequently, if the electric current required bypump 526 exceeds a preset limit, the control board will disable the pump by cutting power to it. Air bubble detection may also be monitored by monitoring the electrical current required to drive the pump at any particular moment. In order for adisplacement pump 526 to reach high fluid pressures, there should be little or no air (which is highly compressible) present in thepump 526 or connecting system (including thecatheter 516 and the extension tubing 514). The fluid volume is small enough that any air in the system will result in no pressure being generated at the pump head. The control board monitors the pump current for any abrupt downward change that may indicate that air has entered the system. If the rate of drop is faster than a preset limit, the control board will disable the pump by cutting power to it until the problem is corrected. Likewise, a block in thehigh pressure lumen 536, which may be due to the entry of organized or fibrous thrombus, or a solid embolus, may be detected by monitoring the electrical current running thepump 526. In normal use, the current fluxuations of thepump 526 are relatively high. For example, the pump may be configured so that there is a variation of 200 milliAmps or greater in the current during normal operation, so that when current fluxuations drop below 200 milliAmps, air is identified, and the system shuts down. Alternatively, current fluxuations in the range of, for example, 50 milliAmps to 75 milliAmps may be used to identify that air is in the system. Additionally, an increase in the current or current fluxuations may indicate the presence of clot or thrombus within thehigh pressure lumen 536. For example, a current of greater than 600 milliAmps may indicate that thrombus it partially or completely blocking thehigh pressure lumen 536, or even theaspiration lumen 538. - A
vacuum line 556, connected to thevacuum source 522, may be connected to anegative pressure sensor 558. If the vacuum of thevacuum source 522 is low or if a leak is detected in thevacuum line 556, thecontrol board 550 disables thepump 526 until the problem is corrected. Thenegative pressure sensor 558 may also be part of asafety circuit 560 that will not allow thepump 526 to run if a vacuum is not present. Thereby acomprehensive safety system 562, including thesafety circuit 560, thepressure sensor 564 and/or theoptical device 566, and thenegative pressure sensor 558, requires both pump pressure and vacuum pressure for the system to run. If a problem exists (for example, if there is either a unacceptably low pump pressure or an absence of significant vacuum), thecontrol board 550 will not allow the user to operate theaspiration system 510 until all problems are corrected. This will keep air from being injected into a patient, and will assure that theaspiration system 510 is not operated at incorrect parameters. -
FIG. 54 is a diagrammatic view of thedistal end portion 568 of the assistedcatheter aspiration system 510, showing more details of thecatheter 516. Thecatheter 516 is a single-operator exchange catheter and includes ashort guidewire lumen 534 attached to the distal end of the device. Theguidewire lumen 534 can be between about 1 and about 30 cm in length, or between about 5 and about 25 cm in length, or between about 5 and about 20 cm in length, or approximately 13.5 cm in length. Anaspiration lumen 538 includes adistal opening 540 which allows a vacuum (for example, from vacuum source 522) to draw thrombotic material into theaspiration lumen 538. Ahigh pressure lumen 536 includes adistal orifice 542 that is set proximally ofdistal opening 540 by a set amount. For example,distal orifice 42 can be set proximally ofdistal opening 540 by about 0.0508 cm (0.020 inches), or by 0.0508 cm±0.00762 cm (0.020 inches±0.003 inches) or by another desired amount. Theorifice 542 is configured to spray across the aspiration lumen to macerate and/or dilute the thrombotic material for transport to vacuumsource 522, for example, by lowering the effective viscosity of the thrombotic material. The axial placement of thefluid orifice 542 is such that the spray pattern interaction with the opposing lumen wall preferably produces a spray mist and not a swirl pattern that could force embolic material out from thedistal opening 540. The system may be configured so that the irrigation fluid leaves the pump at a pressure of between about 3,447,378 pascal (500 psi) and about 10,342,135 pascal (1500 psi). In some embodiments, after a pressure head loss along thehigh pressure lumen 536, the irrigation fluid leavesorifice 542 at between about 4,136,854 pascal (600 psi) and about 8,273,708 pascal (1200 psi), or between about 4,481,592 pascal (650 psi) and about 5,860,543 pascal (850 psi). In some cases, it may be possible (and even desired) to use the assistedcatheter aspiration system 510 without operating thepump 526, and thus use thecatheter 516 while providing, for example, a hand saline injection via a syringe. Or, in some cases, the assistedcatheter aspiration system 510 may be used without thepump 526 attached, with the saline injections done by hand using a syringe through thehigh pressure lumen 536. If a clog occurs, the syringe may be removed and thepump 526 attached and initiated, for example, for the purpose of unclogging thehigh pressure lumen 536. - When normal blood flow is achieved after unblocking occlusions or blockages from atherosclerotic lesions and/or thrombosis, there is sometimes a risk of reperfusion injury. This may be particularly significant following thrombectomy of vessels feeding the brain for treatment of thromboembolic stroke, or following thrombectomy of coronary vessels feeding the myocardium. In the case of the revascularization of myocardium following a coronary intervention (e.g. thrombectomy). Reperfusion injury and microvascular dysfunction may be mechanisms that limit significant or full recovery of revascularized myocardium. The sudden reperfusion of a section of myocardium that had previously been underperfused may trigger a range of physiological processes that stun or damage the myocardium. Distal coronary emboli, such as small portions of thrombus, platelets and atheroma, may also play a part. Controlled preconditioning of the myocardium at risk has been proposed to limit the effect of reperfusion injury and microvascular dysfunction. The embodiments of the
thrombectomy systems -
FIGS. 55A and 55B illustrate athrombectomy system 600 comprising acatheter 606 and a guidingcatheter 608. Thecatheter 606 may be an aspiration or thrombectomy catheter as previously described, and may or may not comprise a proximal sealing member. Alternatively, thecatheter 606 may be used for partial or complete occlusion of the blood vessel distal of the guidingcatheter 608. One purpose for this use is for flow control, as described above, wherein thedistal tube 614 or another portion of thecatheter 606 may be expanded to partially or completely occlude a blood vessel for a period of time. Thecatheter 606 may be a combination of an aspiration catheter and a catheter for flow control or occlusion. For example, the distal end of thedistal tube 614 may provide some flow control in relation to the blood vessel wall, and the proximal end of thedistal tube 614 may provide engagement with the guiding catheter. The guidingcatheter 608 may, for example, have an outer diameter of 6 French, an inner lumen diameter of approximately 0.183 cm (0.072 inches), and have a total length of approximately 100 cm. Thecatheter 606 is configured to be placed through the inner lumen of the guidingcatheter 608. The guidingcatheter 608 may comprise a composite extruded and braided tubular structure, which has sufficient flexibility and pushability to reach a target area. The guidingcatheter 608 may also have a pre-shaped tip. For example, the tip shape may aid in cannulating coronary arteries. Thecatheter 606 comprises adistal tube 614 which is configured to be extendable out of the inner lumen of the guidingcatheter 608, such that adistal end 616 of thedistal tube 614 can be advanced a desired length into the blood vessel so that it can be placed adjacent the target area. Theproximal end 618 of thedistal tube 614 is configured to remain within the inner lumen of the guidingcatheter 608, for example, at a region near the distal end of the guidingcatheter 608. In some embodiments, thecatheter 606 includes a radiopaque marker, which may comprise a band secured to the thrombectomy catheter, and made from radiodense material, such as platinum, gold, or other similar materials. In some embodiments, thedistal tube 614 may be formed of polymeric materials containing radiopaque material, such as titanium dioxide (TiO2). - The
distal tube 614 comprises a tubular braided member whose diameter increases as the distal tube is made shorter (thedistal end 616 andproximal end 618 are brought toward one another) and whose diameter decreases as the distal tube is made longer (thedistal end 616 andproximal end 618 are moved away from one another). A tubular member of this type is sometimes referred to as a “Chinese finger trap.” A stretchable material (such as silicone or urethane) may be used in some embodiments to fill in the spaces between the woven filaments in order to make a water-tight wall. As in certain other embodiments presented herein, asupport member 626 is attached to theproximal end 618 of thedistal tube 614 and is used to track thecatheter 606 through the guidingcatheter 608 and through the vasculature. A push/pull member 605 is attached to thedistal end 616 of thedistal tube 614 and, like thesupport member 626, extends proximally, and out of the proximal end of the guidingcatheter 608 for access by a user. Thesupport member 626 and the push/pull member 605 each have sufficient tensile strength and sufficient column strength such that each can be pushed and/or pulled accordingly, to cause thedistal tube 614 to shorten or lengthen in length, thus changing its diameter. Thesupport member 626 and the push/pull member 605 are each also lockable in relation to each other at their proximal ends, for example, just proximal to the proximal end of the guiding catheter, such that they are no longer able to longitudinally move independent of each other. This locks thedistal tube 614 in its particular condition (diameter and length). Thecatheter 606 may be manipulated by the user so thatsupport member 626 is pulled while the push/pull member 605 is pushed, thus elongating thedistal tube 614 while decreasing its diameter (FIG. 55B ). In this configuration, thedistal tube 614 can be easily inserted through the guidingcatheter 608. Once in a desired location within the vasculature, thecatheter 606 may be manipulated by the user so thatsupport member 626 is pushed while the push/pull member 605 is pulled, thus shortening thedistal tube 614 while increasing its diameter (FIG. 55A ). If this is done while theproximal end 618 of thedistal tube 614 is within the distal tip of the inner lumen of the guidingcatheter 608, an extended lumen may be made, which includes the lumen of thedistal tube 614 and the inner lumen of the guidingcatheter 608. If theproximal end 618 of thedistal tube 614 has a ring of fill or coating material around its outer surface, for example, a stretchable material such as silicone or urethane, a seal may be created between the outer diameter of thedistal tube 614 and the inner diameter of the guidingcatheter 608. This is appropriate for an aspiration catheter mode. If flow control is desired, thedistal tube 614 may be shortened and expanded in the same manner to that it engages the wall of the blood vessel at a desired location. In some embodiments, the push/pull member 605 and/or thesupport member 626 are constructed from hypo tubing, including but not limited to stainless steel hypo tubing or nitinol hypo tubing. -
FIGS. 56A-56C show how the size of thedistal tube 614 may be manipulated to reach different specific diameters. Longitudinally-displacedmarkings support member 626 and/or the push/pull member 605, respectively, may indicate particular corresponding sizes (diameters or lengths) of thedistal tube 614. For example, inFIG. 56A , an approximately 5 French diameter configuration of thedistal tube 614 may be used for delivering it through the guidingcatheter 608. InFIG. 56B , an approximately 6 French diameter configuration of thedistal tube 614 may be used when it is tracked through the vasculature, for example, near a lesion site or target site. InFIG. 56C , an approximately 7 French diameter configuration of thedistal tube 614 may be used when it is expanded towards or against the wall of a blood vessel. One ormore loops 675 are configured to maintain the distance between thesupport member 626 and the push/pull member 605 in the radial direction (in relation to the distal tube 614). In some embodiments, the one ormore loops 675 may be located near theproximal end 618 of thedistal tube 614.FIGS. 56A-56C also show how in some embodiments, the push/pull member 605 may be constructed of flat wire. Thesupport member 626 may also be constructed of flat wire. -
FIG. 57 shows anadditional sleeve 607 which may be placed over thedistal tube 614 to further constrain its diameter for delivery through the guidingcatheter 608 and/or the vasculature. Thesleeve 607 may extend proximally and out the proximal end of the guidingcateteter 608 so that it can be pulled off in a proximal direction to allow thedistal sleeve 614 to expand. Thesleeve 607 may be used in addition to the push/pull member 605, or may be used in lieu of the push/pull member 605 and its utility in relation to thesupport member 626. In an alternative embodiment seen inFIG. 59 , thesleeve 607 may comprise an elongatedistal tube 617 which is coupled to a proximal wire orpusher member 619, this allowing a user to handle both theproximal wire 619 of thesleeve 607 and thesupport member 626 of thecatheter 606 while removing thesleeve 607 from the patient. This would aid in holding thedistal tube 614 at its desired location in the vasculature (and/or in the guiding catheter 608) while removing thesleeve 607. Aportion 621 of thedistal tube 614 which may remain distal of thesleeve 607 may comprise a non-expandable section. -
FIG. 58 illustrates a thrombectomy catheter which may share certain elements of the embodiments ofFIGS. 29-42 . In this particular embodiment, a high pressuresaline injection lumen 609 comprises two or more sections. As depicted, theinjection lumen 609 includes aproximal portion 685, amiddle portion 683 and adistal portion 681. Themiddle portion 683 is configured to telescope within theproximal portion 685 and thedistal portion 681 is configured to telescope within themiddle portion 683. Each portion may be constructed from precision tubing or hypo tubing, such as polyimide or nitinol, such that the difference in diameter between the opposing outer diameter and inner diameter of two neighboring tubes is very small, in order to create a capillary seal between the two. For example, in some embodiments the difference in diameters may be about 0.002 cm (0.0008 inches) or less, or in some embodiments about 0.001 cm (0.0004 inches) or less, or in some embodiments about 0.0005 cm (0.0002 inches) or less. This allows a section ofinjection lumen 609 that has a variable length, while being dynamically sealed, thus minimizing or eliminating any leakage at telescope points 611, 613, and allowing all or the vast majority of the injected saline to exit atexit port 615. In some embodiments, the capillary seal should be liquid tight, or water tight (saline tight), and in some embodiments need not be air tight (gas tight). A progressively smaller inner diameter from theproximal portion 685 to thedistal portion 681 helps to maintain a high pressure jet at the exit port 615 (maximum pressure), without requiring too large of a pump head pressure. During delivery (tracking) of the catheter, a stylet may be placed within theinjection lumen 609 in order to add stiffness, improve transition flexibility and protect the telescope points 611, 613 from damage. The stylet may be removed once the catheter is tracked to its desired location, and prior to the injection of saline and the aspiration of thrombus. In some embodiments, theproximal portion 685 may have an outer diameter of between about 0.0508 cm (0.020 inches) and 0.0732 cm (0.030 inches) or about 0.066 cm (0.026 inches). In some embodiments, themiddle portion 683 may have an outer diameter of between about 0.0305 cm (0.012 inches) and 0.0559 cm (0.022 inches) or about 0.0406 cm (0.016 inches). In some embodiments, thedistal portion 681 may have an outer diameter of between about 0.020 cm (0.008 inches) and 0.0406 cm (0.016 inches) or about 0.0305 cm (0.012 inches). In some embodiments, theproximal portion 685 may have an inner diameter of about 0.559 cm (0.022 inches), themiddle portion 683 may have an inner diameter of about 0.0483 cm (0.019 inches), and thedistal portion 681 may have an inner diameter of about 0.028 cm (0.011 inches). In thedistal portion 681, an inner diameter of between about 0.0229 cm (0.009 inches) and about 0.0381 cm (0.015 inches) optimizes the delivery volume, while minimizing the outer diameter of thedistal portion 681, thus maintaining the largest possible aspiration lumen cross-sectional area. In some embodiments, thedistal tube 614 is a Chinese finger trap (braided tubular member) as previously described, and thus, the telescoping of theinjection lumen 609 tubes allows the length change of thedistal tube 614 freely. In this embodiment or any of the embodiments herein, thedistal tube 614 may comprise a bumper of softer material at the distal end to add atraumatic characteristics. In alternative embodiments which do not require the telescoping of theinjection lumen 609, the multiple layers of different diameter tubes may still be used in order to create a transition from larger diameter to smaller diameter and from stiffer to more flexible moving from the proximal end to the distal end. The tube sections may in this case be adhesively, epoxy or heat bonded together, or may be friction fit.FIG. 64 illustrates possible dimensions and assembly of an embodiment. Theproximal portion 687 may comprise 0.066 cm×0.048 cm (0.026 inches×0.019 inches) stainless steel hypo tubing, for example, 304 series stainless steel. Themiddle portion 689 may comprise 0.066 cm×0.048 cm (0.016 inches×0.013 inches) nitinol tubing. Thedistal portion 691 may comprise polymeric tubing having a proximal outer diameter of about 0.028 cm (0.011 inches) tapering down distally to an outer diameter of about 0.028 cm (0.011 inches). Aradiopaque marker band 693 may be carried on the distal portion having the 0.028 cm (0.011 inches) outer diameter. In some embodiments the highpressure injection lumen 609 may be secured to the inner wall of thedistal tube 614, so that it will not severely flex or kink, and thus interfere with passage of aguidewire pressure injection lumen 609. The highpressure injection lumen 609 may be secured with adhesive or other equivalent techniques. -
FIG. 60 illustrates theproximal end 618 of an embodiment of thedistal tube 614 of thecatheter 606 having an expandingstructure 695 which seals against theinner diameter 643 of the guidingcatheter 608. This may seal via the size of its formed diameter or it may be expandable by the user, for example, by using the combination of thesupport member 626 and the push/pull member 605 described herein. -
FIGS. 61A-61C illustrate the flow control mode of thecatheter 606 for approaching and/or sealing against the blood vessel wall. In some embodiments, thedistal tube 614 may include a portion that has a diameter that is less than the blood vessel diameter. In these embodiments, the push/pull member 605 may be pulled and thesupport member 626 pushed in order to deliver thedistal tube 614 against the vessel wall (while the diameter is increased and the length is shortened). In other embodiments, thedistal tube 614 may include a portion that has a diameter that is about the same or larger than the blood vessel diameter. In these embodiments, the push/pull member 605 may be pushed and thesupport member 626 pulled in order to decrease the diameter (while increasing the length) to allow delivery down the guidingcatheter 608 and through the vasculature.FIG. 61B illustrates thedistal tube 614 extending from the guidingcatheter 608, and expanded to seal against the wall of theblood vessel 102.FIG. 61C illustrates thedistal tube 614 in a reduced diameter state configured for placement through theinner lumen 699 of the guidingcatheter 608. -
FIG. 62 illustrates an embodiment of thedistal tube 614 with the Chinese finger trap in which pulling on the push/pull member 605 causes thedistal tube 614 to invert at an inversion point 697. In some embodiments, the inversion may be done partially and may be used to cause an increase in the diameter of the distal tube 614 (for example, to perform flow control in the blood vessel). In some embodiments, the inversion may be done to remove thedistal tube 614 from the vasculature and into the guidingcatheter 608 or to remove the distal tube from the guidingcatheter 608. By pushing on the push/pull member 605, thedistal tube 614 may be delivered into a location in the blood vessel. -
FIGS. 63A-63B illustrate how both flow control and the coupling to the guidingcatheter 608 may be achieved using two different catheters, labeled inFIG. 63A asfirst catheter 661 andsecond catheter 663. The second catheter 663 (having support member 665) and the first catheter 661 (having support member 667) may each be delivered together within a larger delivery catheter 669 (having support member 671). After delivery through the guidingcatheter 608 and to or near a target site (for example a clot/thrombus and/or an atherosclerotic lesion), thedelivery catheter 669 is removed by pulling it proximally, and thefirst catheter 661 is positioned in theblood vessel 102 for flow control, and/or adjacent athrombus 104, and thesecond catheter 663 is positioned an a coupling manner to the guidingcatheter 608. -
FIG. 65 is an embodiment for acatheter 700 which also makes use of a distal tube using the Chinese finger trap braidedtubular member 714. In this embodiment, awire 702, for example a Nitinol wire, is telescopically located within a proximal 704. In some embodiments, a length of a moreflexible material 706, such as polyimide is attached distal of thewire 702 for a transition of flexibility. Theproximal end 718 of thedistal tube 714 has aseal section 724 for engaging with the guidingcatheter 608. The proximal end of thewire 702 extends proximally of the proximal end of theproximal tube 704. By pushing on theproximal tube 704 and pulling on thewire 702 at each of their respective proximal ends, a user may expand thedistal tube 714 for flow control (e.g. blocking or slowing down blood flow that is coming from the right side ofFIG. 65 to the left side ofFIG. 65 ). A thrombectomy procedure may be performed through the extended lumen comprising the lumen of the distal tube and the inner lumen of the guiding catheter. Any combination of the embodiments disclosed herein may be used to create a combination flow control and thrombectomy embodiment. The thrombectomy portion may include aspiration only, or may combine aspiration and saline injection. -
FIG. 66 illustrates a system forflow control 800 comprising a guidingcatheter 802 for delivery in ablood vessel 102 and aflow control catheter 808 having a self-expandable portion 804. Theflow control catheter 808 has alumen 810 for delivery of a fluid and is pushable and retractable by asupport member 812. Thesupport member 812 may comprise wire with a flat or round cross-section, or may comprise tubing, such as hypo tubing, including stainless steel, Nitinol, polyimide, or other materials. The self-expandable portion 804 is configured to create aseal 814 with theblood vessel 102. In some embodiments, amedicant 816 or drug is delivered through thelumen 810 from a proximal end of theflow control catheter 808 to adistal end 816. Theseal 814 enables themedicant 816 to be delivered into the blood vessel 102 (for example, into thrombus, atherosclerotic plaque, or into the blood vessel wall) with a relatively high concentration, and the self-expandable portion 804 by means of theseal 814 that limits the amount of blood flow that would otherwise dilute themedicant 816. Theseal 814 provided by the self-expandable portion 804 may also in some cases be used to limit the amount of downstream perfusion. This may be helpful in cases in which a stable mechanical environment is desired, such that significant blood flow does not alter the environment in which a procedure is being performed. The control of downstream perfusion may also minimize reperfusion injury by protecting distal tissue from any emboli that may be carried downstream by significant flow, or from the sudden perfusion of oxygen-rich blood in quantities which may create free radicals. Reperfusion injury may result from inflammation or oxidative damage, through the induction of oxidative stress. Though the self-expandable portion 804 may be used to reduce flow or perfusion of theblood vessel 102, in some cases, the self-expandable portion 804 need not entirely block the lumen of theblood vessel 102, thus allowing a controlled, reduced, and tolerable amount of perfusion at the critical period. The self-expandable portion 804 may also provide added support, for example to the guidingcatheter 802, and may serve to center thelumen 810 in theblood vessel 102. In certain embodiments, thelumen 810 may comprise one or more lumens, including at least one aspiration lumen. The self-expandable portion 804 may serve to keep the distal end of the aspiration lumen away from the blood vessel wall, and thus prevent damage to the blood vessel wall, and the keep the tip of thelumen 810 from being blocked (e.g., by the blood vessel wall). - In one embodiment, a system for delivery of a medicant or aspiration of blood or thrombus includes a flow control catheter having a proximal end and a distal end and lumen having a proximal end configured for user access external to a patient, and a distal port, a self-expandable member having an expanded state and a constricted state, and configured to be advanceable through the lumen of a guiding catheter in the constricted state, an elongate support member coupled to the distal end of the flow control catheter and configured to apply a distally-directed force to the distal end of the flow control catheter when a compressive load is applied to the elongate support member, wherein the self-expandable member is configured to move towards its expanded state within vasculature of the patient, when the self-expandable member is moved outside of the lumen of the guiding catheter. In some embodiments, the self-expandable member comprises flat wire. In some embodiments, the self-expandable member comprises round wire. In some embodiments, the self-expandable member comprises hypo tubing. In some embodiments, the self-expandable member comprises at least one of the materials selected from the list consisting of stainless steel, Nitinol, and polyimide. In some embodiments, the self-expandable member is a braided tubular construction. In some embodiments, the braided tubular construction is coated with an elastomeric material. In some embodiments, the lumen of the flow control catheter is configured to deliver a medicant. In some embodiments, the self-expandable member is configured to create a seal against an inner wall of a blood vessel.
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FIG. 67 illustrates acatheter 820 having anexpandable portion 822 having aproximal end 824 and adistal end 826. Theexpandable portion 822 may be self-expandable as described in relation toFIG. 66 , or may be expandable by use of asupport member 828 and a push/pull member 830, as described in relation toFIGS. 56A-56C . Representative dimensions in inches are shown for different sections of theexpandable portion 822. Thedistal end 826 may be twistable and untwistable about alongitudinal axis 832, such that atapered portion 834 may be created. The taperedportion 834 may have a length of between about one cm and about three cm, or may have a length of about 2 cm. Anintermediate portion 833 has a substantially constant expanded diameter, and may have a length of between about two cm and about ten cm, or may have a length of between about three cm and about five cm. A proximal flared portion 835 (in its expanded state) may have a diameter that increases proximally. The proximal flaredportion 835 may have a length of between about six cm and about twelve cm. In some embodiments, theintermediate portion 833 and the majority of the tapered portion 834 (in its untwisted state) have substantially the same outer diameter. In one particular embodiment, this outer diameter may be around 0.068 inches (1.7 mm). The tapered portion 834 (in its twisted state) may taper down from around 0.068 inches (1.7 mm) to around 0.032 inches (0.81 mm) to 0.035 inches (0.89 mm). The proximal flaredportion 835 may gradually increase to an outer diameter on the order of 0.100 inches (2.5 mm). The proximal flaredportion 835 may be collapsible/expandable on its own (without any changes to the taperedportion 834 or intermediate portion 833). For example, the proximal flaredportion 835 may be collapsible so that its entire length has an outer diameter of about 0.068 inches (1.7 mm) and expandable so that the outer diameter starts at about 0.068 inches (1.7 mm) and tapers up to about 0.100 inches (2.5 mm). The entireexpandable portion 822 may comprise a braided tubular structure and may be coated with an elastomeric material, for example, by a dipping process. - In one embodiment, an expandable catheter includes a proximal end and a distal end and a distal port, an expandable member having an expanded state and a constricted state, and configured to be advanceable through the lumen of a guiding catheter in the constricted state, a first elongate member coupled to the distal end of the expandable member and a second elongate support member coupled to the proximal end of the expandable member, wherein compression applied on the first elongate member coupled with tension applied on the second elongate member moves the expandable member towards its constricted state and tension applied on the first elongate member coupled with compression applied on the second elongate member moves the expandable member towards its expanded state. In some embodiments, the distal portion of the expandable member is configured to be twisted into a shape having a tapered diameter.
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FIGS. 68A-68B illustrate aconnection 840 between adistal tube 842 and asupport member 844 which may be utilized in many of the embodiments described herein. Thesupport member 844 transitions to asmaller diameter extension 843. In some embodiments, thesmaller diameter extension 843 extends from within an internal lumen 849 of thesupport member 844, with exterior of thesmaller diameter extension 843 bonded to the interior of thesupport member 844. Askive 845 is angled in relation to a line perpendicular to the longitudinal axis 851, to increase the cross-sectional area of anopening 841 of thelumen 847 of thedistal tube 842. In this manner, the flow through thelumen 847 is not significantly restricted by the cross-sections of thesupport member 844 and thesmaller diameter extension 843. -
FIG. 69A illustrates a system for forcedaspiration 853 including anIV bag 855, atubing set 857 including acassette 859 for coupling to a pump 861, and anaspiration catheter 863 having a y-connector 865, a highpressure delivery tube 867, and anexpandable aspiration lumen 869. Ahigh pressure lumen 871 of the highpressure delivery tube 867 is shown outputting into ajet 873, which flows into theexpandable aspiration lumen 869. Theexpandable aspiration lumen 869 includes anexpandable member 875 which may expand when there is a positive pressure (+P) created by thejet 873 within theexpandable aspiration lumen 869, thus increasing the cross-sectional area of theexpandable aspiration lumen 869 over a length between thedistal end 877 of theexpandable aspiration lumen 869 and a point more proximal at which a pressure drop reduces the pressure within the lumen so that theexpandable member 875 does not expand. Over this section, the volume of the expandedexpandable aspiration lumen 869 is thus increased, allowing for increased flow of the material (thrombus, blood, etc.) being removed. In some cases, aseal 814 may be made against thevessel wall 879 by theexpandable member 875, for example to control flow, though this is optional. The diameter of theexpandable member 875 when expanded may be selected by a user such thatexpandable member 875 does or does not seal against thevessel wall 879 when theexpandable member 875 is expanded. Theexpandable member 875 may be formed integrally with a tubular (non-expandable)portion 881 of theaspiration catheter 863, or may be attached by heat fusing, adhesive, epoxy, shrink tubing, or other joining methods. -
FIG. 69B illustrates theexpandable member 875 when it is not expanded. Thewall 885 of theexpandable member 875 is configured to be foldable into a two or more wings 883 a, 883 b, 883 c to lower its profile and aid is passage through other devices such asintroducer sheaths 897 or guiding catheters and through the vasculature itself. Returning toFIG. 69A , the y-connector 865 includes afirst port 887 which is fluidly coupled to theexpandable aspiration lumen 869, and asecond port 889 which is fluidly coupled to thehigh pressure lumen 871 of the highpressure delivery tube 867. In some embodiments one or both of theports first port 887 is shown coupled to avacuum source 891. A syringe is shown as thefluid source 891 inFIG. 69A , but a vacuum pump or vacuum bottle may instead be used. Anaspiration monitoring system 895 may incorporate any of theaspiration monitoring systems FIG. 69A coupled in such a manner that it is configured to sense a pressure within at least a portion of theexpandable aspiration lumen 869. Anextension tube 893 may be coupled between thevacuum source 891 and theaspiration monitoring system 895. Thecassette 859 may include a piston element such that thecassette 859 and the pump 861 act together as a piston pump for pumping high pressure fluid through thehigh pressure lumen 871 of the highpressure delivery tube 867. A catheter, cassette, and pump system or elements thereof may be utilized such as those disclosed in U.S. Patent Application No. 2015/0327875 to Look et al., published Nov. 19, 2015, which is incorporated herein by reference in its entirety for all purposes. - In an alternative, embodiment, the delivery tube may be used to inject a fluid (saline, drug, etc.) into the lumen of the blood vessel through the distal opening 913 of the
expandable aspiration lumen 869. TheIV bag 855 may be cooled by acooling system 915 in order to deliver cooled fluid, which may be used to cool the entire body of the patient (through circulation) or to selectively cool one or more organs or end structures. A drug may also be cooled to temporarily decrease its activity, or to delay its treatment effectiveness. Alternatively, the drug may be warmed to increase or accelerate its activity. -
FIG. 70 illustratesmateable connectors port 889, instead of standard luer connectors.Connector 903 is sealingly secured to arigid tube 905. Therigid tube 905 may comprise stainless steel, and may comprise hypo tubing. The opposite end of therigid tube 905 may be coupled to flexible tubing.Connector 901 is sealingly secured totubing 907 and includes acavity 909 which is sized to allow the free passage of adistal end 911 of therigid tube 905 when themateable connectors ring 917 is configured to seal over theouter diameter 919 of therigid tube 905. Theconnector 901 and theconnector 903 may include male and female snapping features 921, 923 in order to be able to releasably lock to each other, so that they may reliably maintain the seal between the o-ring 917 and therigid tube 905. In some embodiments, a single tubing set extending between theconnectors FIG. 69A ) includes a connector half, extension tubing, a pump cassette, tubing and a spike (e.g., to the IV bag). The embodiment ofFIGS. 69A-70 facilitates several key treatment modalities in ST segment elevation myocardial infarction (STEMI): platelet inhibition, clot removal, bleeding avoidance, stent apposition, and flow control. - In one embodiment, an aspiration system for removal of material from a lumen, cavity or duct of a patient includes an aspiration catheter having a proximal end and a distal end and comprising an expandable aspiration lumen, a high pressure injection lumen extending within the elongate support member and having a proximal end adjacent the proximal end of the aspiration catheter and a distal end adjacent the distal end of the aspiration catheter, at least one orifice located at the distal end of the high pressure injection lumen configured to allow liquid injected through the high pressure injection lumen to be released at or adjacent a distal end of the expandable aspiration lumen. In some embodiments, the expandable aspiration lumen has an expanded state and a non-expanded state, wherein at least some peripheral walls of the aspiration catheter surrounding the expandable aspiration lumen have a folded shape.
- Although several embodiments have been presented for breaking up or removing thrombus, general aspiration (with or without high pressure saline injection) of normal blood, or other liquids or deposits within the blood vessels, ducts or other tubular or non-tubular cavities of the body is contemplated as being within the scope of the embodiments of the present disclosure.
- Any of the embodiments described herein may utilize the thrombectomy cathteters and pumps described in U.S. Patent Application No. 2007/0073233 to Thor et al. (“Thor”) published Mar. 29, 2007, which is incorporated herein by reference in its entirety for all purposes.
- Any of the embodiments described herein may utilize the thrombectomy catheters described in U.S. Patent Application No. 2001/0051811 to Bonnette et al. (“Bonnette”) published Dec. 13, 2001, which is incorporated herein by reference in its entirety for all purposes.
- Any of the embodiments described herein may utilize the aspiration catheter and separator described in U.S. Patent Application No. 2014/0155931 to Bose et al. (“Bose”) published Jun. 5, 2014, which is incorporated herein by reference in its entirety for all purposes.
- Any of the embodiments described herein may utilize the aspiration catheter and separator described in U.S. Patent Application No. 2010/0204672 to Lockhart et al. (“Lockhart”) published Aug. 12, 2010, which is incorporated herein by reference in its entirety for all purposes.
- Any of the embodiments described herein may utilize the surgical instrument having a cutter described in U.S. Patent Application No. 2007/0225739 to Pintor et al. (“Pintor”) published Sep. 27, 2007, which is incorporated herein by reference in its entirety for all purposes.
- Other contemplated embodiments of an assisted
aspiration system 510 which may be utilized are disclosed in U.S. Patent Application No. 2010/0094201 to Mallaby (“Mallaby”) published Apr. 15, 2010, which is incorporated herein by reference in its entirety for all purposes. Other contemplated aspiration catheters which may be utilized are disclosed in U.S. Patent Application No. 2008/0255596 to Jenson et al. (“Jenson”) published Oct. 16, 2008, which is incorporated herein by reference in its entirety for all purposes. - While embodiments have been shown and described, various modifications may be made without departing from the scope of the inventive concepts disclosed herein.
Claims (20)
1. An aspiration system for removal of material from a lumen, cavity or duct of a patient, comprising:
an aspiration catheter having a proximal end and a distal end and configured to be inserted through a lumen of an elongate tubular member, the elongate tubular member configured for insertion into the vasculature of a subject and having a proximal end, a distal end, the lumen extending from the proximal end to the distal end, and an inner surface defined by the lumen, the aspiration catheter comprising:
a tubular aspiration member having a proximal end, a distal end, and a lumen, and configured to at least partially extend out of the lumen of the elongate tubular member at the distal end of the elongate tubular member and into the vasculature of the subject;
an elongate support member coupled to the tubular aspiration member and extending between the proximal end of the aspiration catheter and the proximal end of the tubular aspiration member;
a high pressure injection lumen extending within the elongate support member and having a proximal end adjacent the proximal end of the aspiration catheter and a distal end adjacent the distal end of the tubular aspiration member, the distal end of the high pressure injection lumen including a curved portion configured to change a direction of fluid flow through the high pressure injection lumen by at least about 90°;
at least one orifice located at the distal end of the high pressure injection lumen configured to allow liquid injected through the high pressure injection lumen to be released into the lumen of the tubular aspiration member; and
an annular seal carried by the tubular aspiration member and configured to create a liquid seal against the inner surface of the elongate tubular member.
2. The aspiration system of claim 1 , wherein the curved portion of the high pressure injection lumen is configured to change a direction of fluid flow through the high pressure injection lumen by approximately 180°.
3. The aspiration system of claim 1 , wherein the curved portion of the high pressure injection lumen and the at least one orifice are contained within a distal portion of the lumen of the tubular aspiration member.
4. The aspiration system of claim 1 , wherein the curved portion of the high pressure injection lumen spans about one cm or less along a longitudinal axis of the aspiration catheter.
5. The aspiration system of claim 1 , wherein the at least one orifice has an inner diameter less than 0.008 inches.
6. The aspiration system of claim 1 , wherein the at least one orifice has an inner diameter of between about 0.003 inches and about 0.004 inches.
7. The aspiration system of claim 1 , wherein the distal end of the high pressure injection lumen is located distally of the distal end of the elongate support member.
8. The aspiration system of claim 7 , wherein the aspiration catheter further comprises a tubular extension having a proximal end coupled to the distal end of the elongate support member such that the high pressure injection lumen extends serially through the elongate support member and the tubular extension.
9. The aspiration system of claim 8 , wherein the curved portion of the high pressure injection lumen and the at least one orifice are carried on a distal end of the tubular extension.
10. The aspiration system of claim 8 , wherein the elongate support member has a first outer diameter and the tubular extension has a second outer diameter, and wherein the first outer diameter is greater than the second outer diameter.
11. The aspiration system of claim 1 , wherein the annular seal comprises an o-ring.
12. The aspiration system of claim 11 , wherein the o-ring has an unstressed inner diameter and is carried by an external portion of the tubular aspiration member having an external diameter, and wherein the unstressed inner diameter of the o-ring is less than the external diameter of the external portion of the tubular aspiration member.
13. The aspiration system of claim 11 , wherein the annular seal further comprises an elastomeric coating covering an external portion of the o-ring and an external portion of the tubular aspiration member adjacent the o-ring.
14. The aspiration system of claim 13 , wherein the elastomeric coating comprises polyurethane.
15. The aspirational system of claim 13 , wherein the elastomeric coating is a dip coating.
16. The aspiration system of claim 13 , wherein the elastomeric coating has a thickness of less than 0.001 inches.
17. The aspiration system of claim 1 , wherein the elongate support member comprises a hypo tube.
18. The aspiration system of claim 1 , wherein the inner surface of the elongate tubular member is located adjacent the distal end of the elongate tubular member.
19. The aspiration system of claim 1 , wherein the proximal end of the tubular aspiration member comprises an angled proximal opening to the lumen of the tubular aspiration member.
20. The tubular aspiration member of claim 19 , wherein the lumen of the tubular aspiration member has a first cross-sectional area and the angled proximal opening of the lumen of the tubular aspiration member has a second cross-sectional area, and wherein the first cross-sectional area is less than the second cross-sectional area.
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US16/504,768 US11540847B2 (en) | 2015-10-09 | 2019-07-08 | Systems and methods for management of thrombosis |
US17/994,765 US20230090845A1 (en) | 2015-10-09 | 2022-11-28 | Systems and methods for management of thrombosis |
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Also Published As
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WO2017062927A2 (en) | 2017-04-13 |
US20230090845A1 (en) | 2023-03-23 |
US20190328410A1 (en) | 2019-10-31 |
US11540847B2 (en) | 2023-01-03 |
WO2017062927A3 (en) | 2017-05-11 |
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