WO2005104781A2 - Thrombectomy and soft debris removal device - Google Patents
Thrombectomy and soft debris removal device Download PDFInfo
- Publication number
- WO2005104781A2 WO2005104781A2 PCT/US2005/014637 US2005014637W WO2005104781A2 WO 2005104781 A2 WO2005104781 A2 WO 2005104781A2 US 2005014637 W US2005014637 W US 2005014637W WO 2005104781 A2 WO2005104781 A2 WO 2005104781A2
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- catheter system
- infusate
- flexible catheter
- ofthe
- helical
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3203—Fluid jet cutting instruments
- A61B17/32037—Fluid jet cutting instruments for removing obstructions from inner organs or blood vessels, e.g. for atherectomy
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/77—Suction-irrigation systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/80—Suction pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00681—Aspects not otherwise provided for
- A61B2017/00685—Archimedes screw
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22038—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire
- A61B2017/22039—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with a guide wire eccentric
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22065—Functions of balloons
- A61B2017/22067—Blocking; Occlusion
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
- A61B2017/22084—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0177—Introducing, guiding, advancing, emplacing or holding catheters having external means for receiving guide wires, wires or stiffening members, e.g. loops, clamps or lateral tubes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M2025/0183—Rapid exchange or monorail catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/0069—Tip not integral with tube
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
- A61M25/007—Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
- A61M25/0082—Catheter tip comprising a tool
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
Definitions
- This application relates generally to medical instruments and methods of use to remove occlusive material from a vessel, duct or lumen within the body of a living being, specifically relating to the removal of thrombus or soft tissue clots from vascular or other lumens.
- a preferred embodiment more particularly concerns a device useful for clearing lumens relying on a device, incorporating at least one pumping means, to aspirate the debris, thereby clearing a partial or complete blockage ofthe vessel or lumen.
- Mechanical thrombectomy devices may be used to restore patency to a vessel that had been at least partially occluded by material.
- rotary catheters may employ a rotary cutting head, a rotating macerator or some homogenization device to remove the clot by the effects of a hydrodynamic vortex generated near the clot.
- some instruments repeatedly drum into the occlusive material, displacing and distorting the material in order to create a lumen therethrough, while leaving the material within the vessel.
- the rotation ofthe cutting head is stated as producing a "differential cutting” effect, whereupon the rotating blade creates a cutting action that removes the relatively hard deposits and selectively leaves the relatively soft tissue.
- Suction ports are provided to pull the hard particles produced by the cutting action into the catheter for removal at the proximal end thereof so that such particles do not flow distally ofthe catheter where they could have an adverse effect on the patients' body, as previously discussed.
- U.S. Patent No. 5,695,507 describes a helically wound coil wire, entrained within a catheter, that may be used to clear a thrombus blocked- vessel by causing the insoluble fibrous meshed strands of fibrin to wrap themselves around the helical wire.
- the fibrin ofthe thrombus material may be drawn to a port by suction applied at the proximal end, thereby engaging the fibrin with the rotating, wrapping action ofthe helical coil wire.
- the fibrin may become wrapped around the wire by the friction between the wire and the thrombus or the "whirling" effect ofthe rapidly rotating wire.
- catheters and methods of use for effecting the opening of a vessel, duct or lumen such as the opening of a atherosclerotic restriction (partial or total occlusion) in an artery.
- catheters are elongated flexible members of sufficient flexibility to enable them to be readily passed through the body ofthe patient to the situs ofthe atherosclerotic plaque in the artery to be opened.
- a working head is mounted at the distal end ofthe catheter and is arranged for high-speed rotation about the longitudinal axis ofthe catheter. In some embodiments the catheter may eject fluid at the working head to expedite the restriction-opening procedure.
- the rotation ofthe working head produces a powerful, toroidal shaped vortex contiguous, or adjacent, with the working head, which has the effect of recirculating any particles that may have been broken off from the material forming the arterial restriction so that the working head repeatedly impacts those particles to reduce their size.
- U.S. Patent 5,074,841 granted to Ademovic et al. there is disclosed a catheter device for performing an atherectomy.
- the device features an exposed series of slots in an outer housing, with a helical cutting blade rotating therein.
- the helical cutting blade in conjunction with the slots, serves to sever the material and the rotary motion draws the fragments towards a grinding face of a ferrule.
- the ground particulate material may then be directed into a pair of flushing lumens, and aided by saline delivered to the site through saline lumens, flushed away from the treatment site.
- Fig. 1 depicts a perspective view ofthe catheter assembly.
- Fig. 7B depicts a safety mechanism ofthe catheter assembly in a high pressure or open mode.
- the aspiration pump only features a helical pump mechanism coupled to a source of rotary power.
- the delivery of an infusate liquid may be accomplished by other methods, such as by high-pressure fluid delivery utilizing a reciprocating positive displacement pump in order to provide an adequate infusate liquid flow rate.
- the infusate fluid is pressurized by the rotating positive displacement action ofthe infusate pump 338, and the infusate fluid is thereby directed through port 330 into the hollow lumen core tube 342 ofthe aspiration pump 340 and is delivered at the distal end ofthe assembly (as will be discussed later).
- the assembly may incorporate a gear mechanism 28 or transmission operatively placed between the motor 26 and the drive shaft 12, wherein the gear mechanism serves to transfer a rotary power applied into rotation ofthe driveshaft 12 and the associated helical pump rotors (i.e., in a 1 : 1 ratio).
- the gearing mechanism may serve to amplify the torque or turning power available for rotating the helical pump mechanisms (by a reduction in gearing ofthe motor relative to the helical pump rotors (e.g., 2:1 or 3:1, etc); most preferably, the gearing mechanism may serve to increase effective gearing in order to increase the rotational speed ofthe driveshaft (e.g., 1 :2, 1:5, 1:50, etc.), so that a given number of turns by the motor will result in more turns ofthe helical pump rotors.
- a preferred embodiment features an increase in effective gearing to ensure that the small diameter helical pump rotors turning within the catheters are able to achieve adequate flow rates and pressures, as will be discussed.
- the helical pump rotors generally, and as utilized for the infusate pump and aspiration pump of this assembly, are designed to turn within a surrounding jacket (e.g., a catheter or lumen), such that as the turning ofthe helical rotor occurs, a positive displacement pumping action is produced by the spirally wound helical pump rotor.
- This principle is based on an Archimedes pump or screw pump system.
- the screw pump system is capable of compact, powerful delivery of a substance.
- the screw pump is also effective at delivery of fluids and particulates, and is relatively unimpeded by the presence of solid materials or foreign debris.
- the ability ofthe helical coil wire 23 to deliver fluid flow is a function of: (a) the rotation speed ofthe helix, (b) the swept volume ofthe helix (the swept volume ofthe helix being the volume of fluid entrapped between the coils of one pitch of the helix), and (c) the leakage or backwards flow along the helix due to the clearance between the helical coiled wire 23 and the infusate catheter jacket 5, as well as the clearance between the helical coiled wire 23 and the infusate core 9.
- the pump can act as a very stiff positive displacement pump, that is, it can deliver flow at a large range of output pressures regardless ofthe inlet pressure. Minimizing leakage is necessary to ensure suitable performance as a fluid delivery catheter system.
- the gap created through the distortion results in a greater tendency for backward leakage; furthermore, rotor turning resistance is increased due to greater friction through the narrowed dimension ofthe ovalized cross-section, and the rotor will resist the flexing force applied, creating more frictional losses.
- a device according to the present invention featuring reduced rotational velocity may be effective in achieving adequate pump flow rates.
- the helical coil pumps ofthe present invention may also feature variable windings or pitches ofthe coiled wires, in order to enhance flexibility or minimize vibrations, or achieve desired pumping characteristics.
- a helical infusate pump 38 having a helical rotor arranged to turn within the infusate catheter jacket 5.
- This rotor has an infusate core member9 having a helical coil member or wire 23 wound around at least a portion or portions ofthe length ofthe core.
- the infusate catheter jacket 5 and rotor extend proximally away from the driveshaft 12, and operatively coupled to a source of fluid (not shown) for infusate delivery.
- the aspiration rotor there is an aspiration core lumen 51, segments of which feature a helical coiled member 49 wrapped around the core lumen 51.
- the coiled member 51 is wound about a hollow central core lumen 51, but is not affixed thereon or affixed only at the proximal end ofthe coiled member 49, at or near the driveshaft 12.
- the torque ofthe driveshaft 12 is transferred along the length ofthe aspiration coiled member 49 to the working head 400 at the distal end ofthe assembly (an enlarged view of which is shown in Fig. 4, to be discussed later).
- the coiled member 49 is spirally wound in an orientation such that as it is rotated, the coil would seek to expand in diameter, tending to unwind, and effectively enhancing the seal ofthe coiled member 49 against the outer aspiration catheter jacket 53.
- the expanded coil member 49 is rotated, some wear occurs at the periphery ofthe coil wire, maintaining a cutting edge (as will be discussed later).
- the infusate may be a liquid (e.g., saline solution, buffer solution, water, etc.) delivered by the present invention in order to flush out debris.
- a contrast medium may be also be delivered as infusate in order to aid in guiding the catheter to the treatment site and direct the application ofthe present invention at the treatment site.
- Delivery of infusate may further include at least one biologically active agent or therapy (e.g., blood, or other oxygen carrying liquid, drugs/T- ⁇ eneficial agents, etc.), a non- exhaustive list of examples of biologically active agents that may be delivered are enumerated in Table 1. Table 1: Examples of Biological Active Ingredients
- Angiotensin Converting Enzyme Inhibitors Angiotensin II antagonists Anti-angiogenic agents Antiarrhythmics Anti-bacterial agents Antibiotics Erythromycin Penicillin Anti-coagulants Heparin Anti-growth factors
- Anti-rejection agents Rapamycin Anti-restenosis agents Adenosine A2A receptor agonists Antisense Antispasm agents Lidocaine Nitroglycerin Nicarpidine Anti-thrombogenic agents Argatroban Fondaparinux Hirudin GPIIb/IIIa inhibitors Anti-viral drugs Arteriogenesis agents acidic fibroblast growth factor (aFGF) angiogenin angiotropin basic fibroblast growth factor (bFGF) Bone morphogenic proteins (BMP) epidermal growth factor (EGF) fibrin granulocyte-macrophage colony stimulating factor (GM-CSF) hepatocyte growth factor (HGF) HIF-1 insulin growth factor- 1 (IGF-1) interleukin-8 (IL-8) MAC-1 nicotinamide platelet-derived endothelial cell growth factor (PD-ECGF) platelet-derived growth factor (PDGF) transforming growth factors alpha & beta (TGF-.alpha., TGF-beta.) tumor necros
- an infusate fluid containing a biologically active agent such as a drug (e.g. table 2), or a particulate or semi-solid material (e.g. table 3) that may serve a benefit upon exposure to the tissue in the region may be introduced as described previously through the infusate fluid. Additionally, the procedure may be performed such that as the catheter is withdrawn, a column of infusate fluid is left remaining in the treatment site.
- the column of infusate fluid is allowed to remain within the vessel for increased effectiveness ofthe treatment (such as through the longer delivery period of a biologically active agent to the tissue).
- the infusate fluid that remains in the region may allow increased opportunity for beneficial effect ofthe material or biologically active agent delivered in the infusate. This effect is especially noticeable in a situation where distal protection is utilized, as there is reduced or no through flow to quickly dissipate or remove the beneficial material.
- the aspiration pump is most preferably in the form of a helical pump, extending distally from the driveshaft 12 into the body, and is a positive displacement pump.
- the rotation ofthe drive shaft 12 causes the helical coiled member 49 to turn, resulting in conveyance of debris via screw pump fluid transport.
- the fluid flow rate for the delivery of infusate fluid may be at the same or different rate as the aspiration fluid flow. Most preferably the rate of aspiration is greater than that ofthe infusate delivery, in order to ensure complete removal of any debris generated. Care must be taken to prevent excessive blood loss and or collapse ofthe lumen due to unbalanced fluid flow rates.
- the adjustment device 55 in order to maintain the appropriate positional relationship between the distal end ofthe coiled member 49 and the working head 400.
- the working head shown in greater detail in Fig. 4, has at least one aspiration inlet port 404 and is operatively coupled to the aspiration catheter jacket 53, in which the coiled member 49 and the core member 51, together comprising the. aspiration pump rotor, are arranged to rotate.
- the adjustment mechanism 55 may include an inner threaded element 59 and outer threaded element 57.
- Rotating the outer threaded element 57 may result in distal movement relative to the inner threaded element 59 (i.e., unscrewing), the aspiration catheter jacket 53 is then driven distally, as the proximal end ofthe aspiration catheter jacket 53 is operatively coupled to the outer threaded element 57. Conversely, rotation in the opposite direction causes proximal movement ofthe aspiration catheter jacket 53, and reduces any gap between the distal end ofthe coiled member 49 and the end ofthe catheter jacket 53.
- the adjustment device allows control of friction between the rotating coiled member 49 inside the cap 402 ofthe working head 400 located at the distal end ofthe aspiration catheter jacket 53.
- the adjustment mechanism 55 allows the proper placement ofthe windings ofthe coiled member 49 within the working head.
- the ability to adjust the position ofthe working head 400 relative to the distal end ofthe coiled member 49 is beneficial in compensating for the effects of wear, bending and expansion of the coiled member 49. If the coiled member is significantly driven up against the inside surface ofthe working head while rotation is applied through the driveshaft 12, friction between the tip ofthe coiled member 49 and the working head 400 will reduce the rotation rate ofthe coiled member, in addition to causing excess wear and generating heat.
- an adjustment can be made to the positioning ofthe helical wire 49 relative to the inlet openings ofthe distal end, and ensure proper operation ofthe assembly.
- the design ofthe aspiration pump 40 having a rotating helical coil member 49 and core lumen 51 within a surrounding jacket 53 may also provide the benefit of separating the occlusive material into components (e.g., a fibrin component and a blood component). This may occur with one design ofthe assembly, where the rotation ofthe coiled member 49 entrains the thrombus material, causing a wrapping action ofthe fibrin making up the thrombus. Additionally platelet material is removed from the treatment site as well through the same aspiration forces, however the nature ofthe platelets does not result in the same winding result that occurs with fibrous material.
- components e.g., a fibrin component and a blood component
- the fibrin winding action may allow the device to effectively remove fibrin and other occlusive material that is entangled within the fibrin, further exposing additional occlusive material for removal by the device that would otherwise have been shielded. Additionally, the winding action of the fibrin facilitates the targeting of removal ofthe clot, and minimizing the impact ofthe device upon the vessel wall.
- the aspiration pump 40 may be activated concurrently with the operation ofthe infusate delivery pump 38.
- the flow rates ofthe infusate delivery pump 38 will be less than the flow rate ofthe aspiration pump 40 (e.g., 3 : 1 ratio of aspiration: infusion rates).
- the rate of infusate delivery can be equal to the rate of aspiration in order to minimize blood loss.
- the safety ofthe patient may require steps to prevent debris release, such as through the use of distal protection devices (e.g., balloons, umbrella filters, etc.) This serves to ensure that the complete removal ofthe debris occurs, and prevents the debris from traveling through the body or blood stream with potentially harmful or fatal results.
- distal protection devices e.g., balloons, umbrella filters, etc.
- the aspiration 40 and infusate 38 pumps are driven off a single driveshaft 12, the driveshaft being propelled by a force applied to the driveshaft (e.g., electric motor, air turbine, hydraulic, etc.).
- a force applied to the driveshaft e.g., electric motor, air turbine, hydraulic, etc.
- incorporation of a safety mechanism 62 may be beneficial.
- the activation ofthe driveshaft 12 may rotate both infusate 38 and aspiration pumps 40 concurrently, however infusate delivery through the distal end ofthe assembly may not be initiated until a safety mechanism 62 is actuated, as will be discussed.
- the safety mechanism 62 operates in response to a change in pressure in an evacuation chamber 60 in fluid communication with the lumen ofthe aspiration pump jacket 53.
- the positive displacement pumping action ofthe helical coiled member 49 draws in fluid and debris material from the treatment site, conveying the aspirant proximally, towards the proximal end ofthe aspiration pump, and eventually through to the evacuation chamber 60, resulting in a pressure increase therein.
- the safety mechanism of an embodiment features dual valves (first valve 64, and second valve 66) actuated mechanically in response to an increase in fluid pressure present in the evacuation chamber 60.
- first valve 64, and second valve 66 dual valves
- the infusate pathway to the treatment site through the hollow lumen ofthe aspiration core lumen 51 remains available for fluid flow; however, the path having the least fluid resistance is through the infusate bypass lumen 68 towards a waste reservoir.
- substantially all infusate fluid flow is through the first safety valve 64 opening, and is shunted towards the waste reservoir through waste lumen 56, rather than through the distal arm ofthe assembly comprising the aspiration catheter 53 into the body.
- the second safety valve 66 Upon actuation ofthe second safety valve 66, fluid flow from the evacuation chamber 60 towards the waste lumen 56 is allowed, and continues until the pressure actuating the second safety valve 66 drops below the pressure level required to maintain the second safety valve in an open state.
- the second safety valve may also be mechanically or electronically actuated.
- the second safety valve is a mechanical valve (e.g., a ball and spring check-valve arrangement) wherein the pressure within the evacuation chamber 60 causes the valve to open and allow fluid flow.
- the design ofthe safety mechanism 62 serves to prevent infusate delivery without a corresponding activity ofthe aspiration pump 50.
- As pressure created by the aspiration pump is required to enable the delivery of infusate to the treatment site, should the aspiration pump suffer a failure (e.g., due to breakage, clog, etc.) the infusate delivery is disabled as the aspiration pressure drops, and the infusate liquid is then shunted towards the a waste reservoir, rather than towards the patient.
- a warning mechanism for the operator may be incorporated, as most likely, the operator would otherwise be unable to determine if the aspiration pump 40 was not operating properly. This is due to the fact that the driveshaft 12 will continue to be driven by the source of power, actuating the pumping mechanism regardless of a clog or failure ofthe components.
- This warning mechanism could be accomplished through the incorporation of a cut-off switch to halt the operation ofthe device or more preferably a warning indicator (e.g., a light, sound, etc.) to alert the operator as to the condition ofthe safety mechanism, either relying on the actuation ofthe first safety valve, the second safety valve, or alternatively by an entirely independent pressure switch in the fluid pathway.
- An alternate embodiment ofthe safety mechanism may be incorporated into the present invention, in which the device is disabled (e.g., power to motor removed) if there is an imbalance or deviation from the desired pressures in the infusate and aspiration pump mechanism.
- a sensor, or monitor could be utilized to track and respond to deviations in operation ofthe aspiration pump (e.g., deviations in aspiration pressure, aspiration flow rate, etc.), thereupon triggering a responsive event, such as alerting the operator to a malfunction, and/or disabling the device, at least temporarily.
- a safety switch 8 that upon a deviation from a desired aspiration pressure, disables the automatic operation ofthe infusate pump.
- the safety mechanism 62 serves to prevent harm to the patient, such as may be accomplished by limiting the rate of flow (infusate and/or aspiration) from either or both ofthe infusion or aspiration pumps, or limiting or disabling the power source providing for the rotation ofthe infusion and/or aspiration rotor(s) ofthe catheter assembly.
- the safety mechanism 62 may also serve to prevent operation ofthe device at rotational speeds which might cause harm to the catheter assembly, were the temperatures not controlled.
- the safety mechanism is operated by a pressure generated by the operation ofthe catheter assembly.
- the safety mechanism responds to a change in pressure within an evacuation chamber 60, which is in fluid communication with the lumen ofthe aspiration pump jacket 53.
- Fig. 7A and 7B depict the evacuation chamber 60 as being directly connected to the aspiration catheter jacket 53, however, it is recognized that the evacuation chamber may be connected by a separate and distinct intervening lumen branching into the aspiration catheter jacket, or other methods of delivering pressure to the evacuation chamber as known in the art.
- a diaphragm 708 material may be caused to elastically expand in response to increasing pressure within the evacuation chamber 60. As the pressure within the evacuation chamber increases, the diaphragm translates this fluid pressure increase into motion, and as the diaphragm 708 distorts, it may activate a sensor or switch 706, as can be seen in Fig. 7B.
- the pressure increase within the evacuation chamber may be facilitated by a restriction at the outlet ofthe evacuation chamber, such as a regulator or a pressure sensitive valve.
- a restriction at the outlet ofthe evacuation chamber such as a regulator or a pressure sensitive valve.
- the regulator 710 may be a pressure sensitive valve, similar to a ball and spring checkvalve, or alternatively may be a pressure sensitive constriction which opens and closes in response to the pressures the regulator is exposed to.
- the regulator 710 features an elastomeric material, such as a spring 714, which may be coupled to a support 712, to affect the compression upon a deformable material making up at least a portion ofthe lumen.
- the regulator serves as a flow restriction to ensure that adequate pressure is preserved within the evacuation chamber 60 to maintain the elastic distortion ofthe diaphragm 708 as long as is necessary for proper operation ofthe device. It is recognized that the regulator need not completely block all fluid flow when closed, as long as fluid flow rates, while above a minimum level, will result in the necessary pressure increase within the evacuation chamber 60.
- the regulator 710 remains closed or nearly closed to fluid flow while there is low pressure within the evacuation chamber 60.
- the regulator 71 prevents the free flow of fluid until adequate pressure is achieved; and as the pumping ofthe aspiration helical pump continues, the pressure within the evacuation chamber increases, causing diaphragm distortion.
- the regulator responds to the pressure increase by allowing an amount of flow therethrough that matches the flow delivered by the pumping action, as is depicted in Fig. 7B.
- the regulator 710 and diaphragm 708 will compensate by reverting back to the low pressure mode, preferably in proportion to the decrease in pressure experienced within the evacuation chamber 60.
- the diaphragm disengages from the sensor, or alternatively triggers a second sensor (not shown), indicating a reduction in pressure within the chamber 60
- the device responds by at least partially disabling the catheter assembly, such as by reducing or eliminating the source of power, thereby reducing pumping speeds or completely eliminating any pumping action altogether.
- the assembly 1 features a working head 400 at the distal end ofthe assembly to be introduced into the patient for the procedure; examples ofthe working head are depicted in Figs. 4, 5, and 6.
- the working head 400 is operatively connected to the aspiration pump 40 of Fig. 2A.
- the working head features a cap 402 physically attached to the aspiration catheter jacket 53, and the helical coils ofthe aspiration coiled member 49 rotating within the cap.
- occlusive material 426 which may be a lesion, deposit or stenosis.
- occlusive material 426 which may be a lesion, deposit or stenosis.
- a distal protection measure 444 At or near the distal end ofthe guidewire may be a distal protection measure 444, as shown.
- the distal protection measure serves to prevent debris from traveling away from the treatment site, such as by preventing the free flow of fluid with a balloon (as shown) or alternatively, such as through the use of a filter mechanism to capture any debris or loosened occlusive material 426. It is recognized that the use ofthe device may not require the use of distal protection, relying on the safe aspiration of fluid and occlusive material through the operation ofthe aspiration pump as described earlier.
- FIG. 5 Another embodiment ofthe cap portion ofthe working head is depicted by Fig. 5.
- the cap 502 provides at least one aspiration inlet port 504 to be located at or near the distal end ofthe assembly, thereby allowing material to pass through the inlet port 504, and, with reference to Fig. 2A, into contact with the aspiration coiled member 49 comprising the rotor ofthe aspiration pump 40 within the aspiration pump jacket catheter 53.
- the cap 502 also features an infusate delivery port 506, and a guidewire following means 508.
- inlet ports An appropriate number and sizes of inlet ports will result in fragmentation of occlusive material into manageable sizes for the aspiration pump (i.e., less than the distance between adjacent windings ofthe coiled wire), and further provide for adequate flow rates generated by the rotation ofthe aspiration pump.
- the placement, number and size ofthe inlet ports may be varied, limited in size by the performance (e.g. adequate suction velocity) requirements as previously described, and also limited by the size or surface area ofthe working head.
- the inlet ports 404 have a sharp cutting edge forming the periphery ofthe port.
- any material drawn into the windings ofthe aspiration rotor will be cut by the sharpened edge ofthe inlet ports in a shearing action, forming fragments of a size capable of being conveyed by the aspiration pump.
- the inlet ports may sit flush with the outer diameter of the jacket, or alternatively, and preferably, countersunk in order to prevent contact of a sharpened cutting edge with non-targeted tissue.
- the countersinking process may inherently produce a scalloped cutting edge, as can be seen in the depiction of a counter sunk inlet port 404 of Fig. 4.
- Fig. 6 depicts an elevated profile view of another embodiment ofthe working head ofthe present invention.
- This embodiment while mechanically functioning in a similar manner to the embodiment described with reference to Fig. 4, features an alternative guidewire arrangement (to be discussed) having an atraumatic tip 616, and further has a band 620 arranged to fasten the working head 400 onto the aspiration catheter jacket 53.
- the band may be placed in a manner so that it restricts the independent movement ofthe working head 400, such as by being a crimp, or a polymer coating, such that the working head is attached.
- the band may be radiopaque, and serve as a marker to track the progress ofthe device during a procedure.
- cap 602 in this or another embodiment, may similarly serve as a radiopaque marker.
- a plurality of scalloped or countersunk aspiration inlet pores are provided, and allow for the drawing of debris and material into the windings ofthe aspiration pump, as described previously.
- a plurality of infusate delivery ports 406, are depicted in this embodiment in a radial orientation, though other arrangements may be beneficial.
- the aspiration coiled member 49 may also feature a cutting edge.
- the coiled member may be at least partially formed having an acute edge that acts upon the target tissue.
- the aspiration coiled member at or near the distal end ofthe assembly has a cross-section comprising at least one edge (e.g., planar, triangular, rectangular, square, etc.) that serves to sever the tissue against the inlet port 404, cap 402, or aspiration catheter jacket 53, macerating the material into manageable sizes for the aspiration pump as the coiled member rotates.
- the rotation ofthe coiled member may serve to sever the tissue against the aforementioned edge of an aspiration inlet port.
- the fibrin in the material may be further reduced into smaller fragments by the maceration as a consequence ofthe rotation ofthe cutting edge ofthe coiled member 49.
- the maceration occurs where thrombus material is further severed by the individual windings ofthe aspiration coiled member pinching the thrombus material against the inner surface ofthe cap 402 or the extraction catheter jacket 53.
- a cutting edge may be maintained upon the outside circumference ofthe coiled member, allowing it to more easily sever the tissue drawn in through the inlet port 404.
- the unwinding that occurs as the coiled member 49 is torqued also forces the coiled member outwards as it tends to unwind away from the central core lumen, and against at least one inlet port 404 at the distal end, further enhancing the ability ofthe assembly to fragment the occlusive material into more manageable fragment sizes.
- an aspiration pump 40 having a rotor with at least a portion ofthe length ofthe rotor (e.g., at or near the distal end ofthe aspiration rotor) having a diameter smaller than the inside diameter ofthe catheter jacket 53 in which the rotor resides, as this affords the opportunity for at least a portion ofthe rotor to move somewhat independently ofthe catheter jacket.
- an eccentric rotation ofthe distal end ofthe rotor is possible, such that, upon rotation, at least a portion ofthe aspiration coil wire 49 is directed firmly against the inside diameter ofthe aspiration catheter jacket.
- the aspiration core lumen preferably does not penetratre through to the distal end ofthe cap 402, and instead provides for a seal at the juncture ofthe aspiration core lumen and against the material ofthe cap, in order to prevent the infusate fluid from being drawn into the aspiration lumen by the action ofthe aspiration pump.
- the infusate fluid that is delivered through the aspiration core lumen is then directed into the cap for delivery through the infusate delivery ports 406 as described previously.
- the present invention may be operated either with or without a standard guidewire in place. If no guidewire is to be in place during operation ofthe instrument, a standard guidewire maybe utilized for the purposes of aiding the navigation ofthe device to the treatment site (e.g., through tortuous vasculature) using techniques known in the art. Once in place, the guidewire may be removed, in order to allow operation ofthe present invention. Alternatively, the device may be placed in position without the assistance of a standard guidewire, using catheterization techniques known in the art.
- the device may follow along a guidewire running through a central coaxial lumen within the device (not shown).
- the device navigates following a guidewire in a monorail fashion.
- the assembly travels alongside the guidewire, and at least a portion ofthe catheter is operatively coupled to the guidewire.
- the delivery ofthe assembly to the target site is accomplished by the assembly traveling alongside the pre-placed guidewire to arrive at the target destination.
- This monorail embodiment provides a further benefit for it allows a central bore ofthe aspiration core lumen to remain unobstructed for delivery of infusate.
- at or near the distal end ofthe device there is provided an opening for the guidewire to pass through, and ensures that device follows along the guidewire to arrive at the treatment site.
- the device is arranged to slidably follow the guidewire in monorail fashion, additionally there may be provided an additional exterior guidewire lumen 412 to ensure the device more closely tracks the path ofthe guidewire, in order to prevent harm to the vasculature ofthe patient.
- This may be accomplished by providing an exterior lumen side-by-side with the aspiration pump, for maintaining close proximity to the guidewire, the guidewire lumen having a distal end located proximately ofthe working head ofthe device.
- the cross-section ofthe device at the working end is minimized and flexibility is enhanced, further allowing the device to travel more tortuous bends without causing damage to the patient, as at least a portion ofthe guidewire near the distal end of the assembly is free to flex independently ofthe aspiration catheter jacket.
- the working head 500 featuring a cap 502 having at least one aspiration inlet port 504, an infusate delivery port 506, and a guidewire following means 508.
- the guidewire following means features an opening in the distal tip, through which a guidewire may be slidably arranged. In this manner, the catheter assembly can follow along the guidewire as the assembly is urged further into the body, in order to arrive at the treatment site.
- a flexible atraumatic tip 416 at the distal end ofthe working head 400 the atraumatic tip being operatively attached to the cap 402 ofthe working head.
- the means of attaching the working head may be through physically interlocking componets at the junction, or a restraining band may be utilized to maintain positional relationship. It is recognized that other means known in the art for attachment (such as adhesive, welding, are capable of functioning similarly to prevent dislodging ofthe distal tip material from the working head.
- the atraumatic tip 416 is preferably a compliant biocompatible material (e.g., nitinol, silicone, latex, PTFE, etc.), or a compliant material coated with a biocompatible coating to enhance slidability, and features an opening 408 at the distal end ofthe atraumatic tip through which a guidewire may be slidably arranged.
- the compliant atraumatic tip 416 is able to conform to the bend ofthe vessel, in order to help guide the catheter as it is urged further into the patient.
- the flexible atraumatic tip 416 may further feature a recessed area or channel 418 in order to accommodate a portion ofthe guidewire, further reducing the cross-sectional area ofthe atraumatic tip as it follows the guidewire.
- This embodiment enhances the ability ofthe device to navigate bends in na ⁇ ow vessels, without causing harm to the vessel, as the distal tip ofthe working head 400 with the flexible atraumatic tip 416 more easily navigates the bends and helps conform the vasculature to accept the passage ofthe assembly.
- This embodiment featuring a flexible atraumatic tip 416 may also feature the side-by-side guidewire lumen 412, as discussed above. As shown, the guidewire (not shown) would be free to flex independently ofthe device for a portion running alongside working head 400 ofthe device.
- the independently flexible portion ofthe guidewire would serve to ensure that the guidewire is not interfering with the bend ofthe catheter in traversing a sharp narrow bend in the vasculature, as the guidewire would be displaced alongside the bending ofthe catheter, rather than affixed on the outside or the inside ofthe bend, and further adding to the cross-section that needs to be bent in order to comply with the vasculature.
Abstract
Description
Claims
Priority Applications (4)
Application Number | Priority Date | Filing Date | Title |
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EP05756109A EP1747032B1 (en) | 2004-04-27 | 2005-04-27 | Thrombectomy and soft debris removal device |
CA002565452A CA2565452A1 (en) | 2004-04-27 | 2005-04-27 | Thrombectomy and soft debris removal device |
AU2005237620A AU2005237620A1 (en) | 2004-04-27 | 2005-04-27 | Thrombectomy and soft debris removal device |
JP2007510979A JP2007534450A (en) | 2004-04-27 | 2005-04-27 | Device for thrombectomy and removal of soft debris |
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US10/832,830 US7959608B2 (en) | 2004-04-27 | 2004-04-27 | Thrombectomy and soft debris removal device |
US10/832,830 | 2004-04-27 |
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WO2005104781A2 true WO2005104781A2 (en) | 2005-11-10 |
WO2005104781A3 WO2005104781A3 (en) | 2006-03-30 |
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PCT/US2005/014637 WO2005104781A2 (en) | 2004-04-27 | 2005-04-27 | Thrombectomy and soft debris removal device |
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EP (2) | EP2314329A1 (en) |
JP (1) | JP2007534450A (en) |
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CA (1) | CA2565452A1 (en) |
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EP1747032A4 (en) | 2008-01-09 |
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EP1747032B1 (en) | 2011-05-18 |
CA2565452A1 (en) | 2005-11-10 |
US20050240146A1 (en) | 2005-10-27 |
WO2005104781A3 (en) | 2006-03-30 |
EP1747032A2 (en) | 2007-01-31 |
AU2005237620A1 (en) | 2005-11-10 |
EP2314329A1 (en) | 2011-04-27 |
US20100145259A1 (en) | 2010-06-10 |
US7976528B2 (en) | 2011-07-12 |
US7666161B2 (en) | 2010-02-23 |
US7959608B2 (en) | 2011-06-14 |
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