Patent Grant
12171917
Thrombotic restrictions and occlusions within a patient's blood vessels are a significant medical problem and often require intervention to remove these restrictions and blockages to restore health to patients. While applicable to a wide range of vascular applications in both the arterial and venous systems, including a variety of small vessels, the following background illuminates the problems primarily through the example of patients suffering with Pulmonary Embolisms.
Venous thromboembolic disease (VTE) is a worldwide crisis. There are over 10 million cases of deep vein thrombosis (DVT) and pulmonary embolism (PE) diagnosed globally per year, with 1 million cases occurring in the United States and over 700,000 in France, Italy, Germany, Spain, Sweden, and the United Kingdom combined each year. There are approximately 60,000 to 100,000 deaths from PE in the United States each year. DVT and PE are part of the same continuum of disease, with over 95% of emboli originating in the lower extremities. When PE occurs, the severity depends on the embolic burden and its effect on the right ventricle as well as underlying cardiopulmonary comorbidities. Death can result from the acute increase in pulmonary artery (PA) pressure with increased right ventricular (RV) afterload and dysfunction.
Patients with high-risk pulmonary embolism (PE) were treated primarily with thrombolytic therapy delivered systemically or more locally through Catheter Directed Thrombolytics. These approaches result in multiple catheterization lab visits, lengthy hospital stays and often lead to bleeding complications. Newer approaches to PE treatment include single session thrombectomy treatments without the use of thrombolytics. These thrombectomy treatments include delivering a catheter into the PA to remove the thrombus through aspiration, and secondary tools may also macerate or disrupt the thrombus prior to aspiration. While thrombectomy results in fewer bleeding complications and reduced hospital stays compared to thrombolytics, there is much to be improved upon given the challenges of the procedure itself, including the ability to capture a broad spectrum of thrombus types and reduce the total volume of blood loss during the procedure.
The thrombectomy catheter is introduced through an introducer puncture in a large diameter vein. A flexible guide wire is passed through the introducer into the vein and the introducer is removed. The flexible guidewire provides a rail for a flexible guide catheter to be advanced through the right atrium into the right ventricle and into the pulmonary artery. The flexible guidewire is removed and replaced with a stiff guidewire. The large diameter thrombectomy catheter with support dilator is then advanced over the stiff guidewire to the pulmonary artery and the dilator is removed. If the large diameter thrombectomy catheter is not successful in accessing or aspirating thrombus in a more distal portion of the vessel, a smaller diameter catheter may be inserted through the large diameter catheter.
In addition, peripheral arterial occlusive (PAO) disease occurs in more than 4% of individuals over age 40 and markedly increases in incidence after the age of 70. Acute PAO is usually due to thrombosis of the peripheral vasculature and is associated with a significant risk of limb loss. In order to preserve the limb, therapy for acute PAO centers on the rapid restoration of arterial patency and blood flow such as through mechanical thrombectomy in procedures similar to those described above.
Clot aspiration using certain commercial vacuum-assisted thrombectomy systems may sometimes need to be terminated due to the risk of excessive blood loss by the patient, especially when using large aspiration catheters. During aspiration thrombectomy, when the catheter tip falls out of contact with the thrombus or other occlusive material, the tip is exposed to healthy blood and full flow of blood through the catheter ensues. Under such conditions, the total volume of blood loss is excessive, and in some cases, may result in premature termination of the procedure. For example, during a procedure when the catheter enters healthy blood and full aspiration flow ensues, the blood loss rate can be on the order of 20-30 cc per second with an 24 French size catheter. In order to minimize blood loss, the catheter should not run in unrestricted mode for more than approximately 10 to 15 seconds. The aggregate blood loss may reach an unacceptable level before sufficient clot is removed.
There is provided in accordance with one aspect of the present disclosure a blood reintroduction system. The blood reintroduction system can include a sterile canister configured to collect blood, an inlet configured to be fluidly connected to a first tubing in fluid communication with an aspiration system configured to apply aspiration to a vasculature of a patient, a first outlet configured to be fluidly connected to a second tubing in fluid communication with an aspiration pump, and/or any vacuum source such as a syringe, and a second outlet configured to interact with a blood reintroduction device. The blood reintroduction device can be configured to withdraw the blood collected inside the sterile canister. The blood reintroduction device can include a filter positioned inside a flow path extending through the second outlet.
In some aspects, the filter can be positioned anywhere between the sterile canister and the vasculature of the patient.
In some aspects the filter is positioned inside the sterile canister.
In some aspects, the filter is positioned outside the sterile canister.
In some aspects, the filter is in fluid communication with the syringe.
In some aspects, the filter is in fluid communication with patient tubing and/or a patient port.
The inlet may be configured to direct an incoming stream of blood along an inside surface of the canister. In one implementation, the canister may have a curved wall such as in a cylindrical canister. The inlet may be configured to direct an incoming stream of blood along a circumferential path along the inside surface of the canister.
In some aspects, the filter is positioned between a chamber defined by the sterile canister and an opening of the second outlet. The filter can be configured to filter the blood before the blood is withdrawn from the sterile canister via the second outlet.
In some aspects, the inlet can be positioned on an upper portion of the sterile canister.
In some aspects, the first outlet can be positioned on an upper portion of the canister.
In some aspects, the canister further includes a base defining a blood collection cavity.
In some aspects, the filter is at least partially disposed inside the cavity. The second outlet can be positioned adjacent to the cavity.
In some aspects, the blood reintroduction device includes a syringe.
In some aspects, the blood reintroduction device includes a venous line in fluid communication with vasculature of the patient. A pump fluidly connected to the venous line can be configured to advance the blood withdrawn from the sterile canister into the vasculature of the patient.
In some aspects, the aspiration system includes a thrombectomy catheter and an aspiration catheter configured to be advanced through the thrombectomy catheter.
In some aspects, aspiration from the aspiration pump or any vacuum source, such as a syringe, is configured to draw blood from the first tubing into the sterile canister.
In some aspects, a longitudinal axis of the second outlet is positioned at an acute angle relative to a base of the sterile canister.
In some aspects, a longitudinal axis of the second outlet is positioned at a right angle relative to a base of the sterile canister.
In some aspects, the first and second tubing are configured to permit the sterile canister to reside within a sterile field.
In accordance with another aspect of the present disclosure, there is provided a method of capturing blood for reintroduction into a vasculature of a patient during an aspiration procedure. The method can include providing a canister to be placed in fluid communication with the vasculature of a patient. The canister can include an inlet, a first outlet, and a second outlet. The method can also include applying aspiration to the canister via the first outlet, and aspirating blood from the patient and into the canister via a first tubing connected to the inlet. The method can include filtering the blood collected inside the canister using a filter positioned in fluid communication between an opening of the second outlet and at least a portion of an internal space of the canister. The method can include withdrawing filtered blood from the canister via the second outlet.
In some aspects, the method can include introducing the filtered blood withdrawn from the canister into the vasculature of a patient.
In some aspects, applying aspiration to the canister via the first outlet includes connecting the first outlet with an aspiration pump via a second tubing.
In some aspects, aspirating blood from the patient and into the canister via the first tubing connected to the inlet includes inserting a thrombectomy catheter into the vasculature of the patient and advancing an aspiration catheter inside the thrombectomy catheter.
In some aspects, filtering the blood collected inside the canister using the filter positioned between the opening of the second outlet and at least the portion of the internal space of the canister includes flowing the blood through the filter to cause filtering of solid material.
In some aspects, the solid material comprises a blood clot and/or a thrombus.
In some aspects, withdrawing filtered blood from the canister via the second outlet includes coupling a syringe to the second outlet and withdrawing blood into the syringe.
In some aspects, withdrawing filtered blood from the canister via the second outlet includes connecting a first end of a venous line into the vasculature of the patient and a second end of the venous line to the second outlet. The method can also include pumping the filtered blood through the venous line using a pump fluidly connected to the venous line.
In some aspects, filtering the blood collected inside the canister using the filter positioned between the opening of the second outlet and at least the portion of the internal space of the canister includes collecting solid matter inside the filter.
In some aspects, withdrawing filtered blood from the canister via the second outlet can be done without interrupting application of aspiration to the canister via the first outlet.
In some aspects, the method can include prefiltering the blood prior to aspirating the blood into the canister using a second filter positioned along the first tubing.
In some aspects, filtering the blood collected inside the canister using the filter includes filtering solid materials of a first size, prefiltering the blood prior to aspirating the blood into the canister using the second filter includes filtering solid materials of a second size. In some aspects, the second size can be greater than the first size. In some aspects, the solid materials can include a thrombus.
In some aspects, aspirating blood from the patient and into the canister can include positioning the inlet to direct a flow of blood to an interior wall of the canister.
In some aspects, aspirating blood from the patient and into the canister includes collecting the blood within a base of the canister, the base comprising a first portion and a second portion, the first portion comprising an inclined surface and the second portion defining a dip.
In some aspects, filtering the blood collected inside the canister using the filter includes positioning at least a portion of a distal end of the filter within the dip so that the distal end of the filter is in contact with the blood collected in the dip.
In accordance with another aspect of the present disclosure, there is provided a blood reintroduction system. The blood reintroductions system can include a housing having a chamber configured to collect blood, an inlet configured to fluidly connect the chamber to a first tubing in fluid communication with an aspiration catheter, a first outlet configured to fluidly connect the chamber to a second tubing in fluid communication with an aspiration pump, and a second outlet configured to interact with a blood reintroduction device.
In some aspects, the blood reintroduction system is configured to reside within a sterile field.
In some aspects, the blood reintroduction system can include a filter positioned between an interior portion of the housing and an opening of the second outlet.
In some aspects, the blood reintroduction device is configured to withdraw blood collected inside the housing.
In some aspects, the blood reintroduction device includes a syringe.
In some aspects, the second outlet includes a luer fitting.
In some aspects, the aspiration catheter is configured to apply aspiration to a vasculature of a patient.
In some aspects, the housing includes a base defining a floor. The floor can include a first portion and a second portion. The first portion can include an inclined surface and the second portion can define a dip. The inclined surface of the first portion can facilitate flow of the blood collected inside the housing towards the dip defined by the second portion.
In some aspects, the blood reintroduction system can further include a filter. The filter can include a proximal end and a distal end. The distal end of the filter can be positioned at least partially within the dip defined by the second portion of the floor.
In some aspects, the blood reintroduction device can be configured to withdraw blood collected inside the canister while aspiration is applied by the aspiration pump.
In some aspects, the blood reintroductions system can include a filter positioned between the inlet and the aspiration catheter, the filter configured to capture thrombus as blood flows through the first tubing.
In some aspects, the blood reintroduction device includes a second tubing comprising a first end and a second end, the first end connected to the second outlet and the second end in fluid communication with a vasculature of a patient.
In some aspects, the second tubing can be in fluid communication with a pump, the pump configured to move the blood from the chamber to the vasculature of the patient via the tubing.
In some aspects, the blood reintroduction device includes a filter assembly having a filter housing, a filter positioned inside the filter housing and a cap configured to secure the filter housing to the housing of the blood reintroduction system.
In some aspects, the cap can be movable between at least an open position where the filter housing is not secured to the housing of the blood reintroduction system, and a closed position where the filter housing is secured to the housing of the blood reintroduction system.
In some aspects, at least a portion of the filter assembly can be positioned within the chamber and wherein at least a portion of the filter is in contact with the blood when blood is collected inside the chamber.
In accordance with another aspect of the present disclosure, there is provided a canister for use in a blood reintroduction system. The canister can include a housing, a base including a floor, the floor defining an inclined surface and a blood collection low point. The housing and the base can define a chamber configured to collect blood. The canister can include an inlet configured to be fluidly connected to a first tubing in fluid communication with a thrombectomy catheter. The inlet can be oriented to direct flow of blood along an interior side wall of the housing. The canister can include a first outlet configured to be fluidly connected to a second tubing in fluid communication with an aspiration pump, and a second outlet configured to interact with a blood reintroduction device. The blood reintroduction device can be configured to withdraw the blood collected inside the chamber. The canister can include a filter disposed between an opening of the second outlet and the chamber.
In some aspects, the inlet and the first outlet are positioned on an upper portion of the housing.
In some aspects, the inlet and the first outlet are positioned in an elevated position relative to the second outlet.
In some aspects, the filter includes a proximal end and a distal end. The distal end of the filter can be positioned adjacent the blood collection low point.
In some aspects, the filter and a bottom surface of the base define an acute angle.
In accordance with another aspect of the present disclosure, there is provided a filter assembly for use in a blood reintroduction system. The filter assembly can include a filter housing including a proximal end and a distal end, a cap removably secured to the proximal end of the filter housing, and a filter including a proximal end and a distal end. The filter can be positioned inside the filter housing. The filter assembly can include a luer fitting secured to the cap and configured to be in fluid communication with a blood reintroduction device. The filter housing can be configured to be at least partially disposed inside a canister.
In some aspects, a longitudinal axis of the filter housing can be positioned at an acute angle relative to a base of the canister.
In some aspects, the filter includes a filter having a pore size between 20 and 200 microns.
Referring to
Thrombectomy catheter 102 comprises a proximal handle 106 having an elongate flexible tubular catheter body 108 extending distally therefrom. The proximal end 110 of the tubular body 108 may be permanently carried by the proximal handle 106 or may be provided with a releasable connector for detachable connection to a complementary connector on the handle 106.
In one implementation, the tubular body 108 or 152 or both are provided with a flexible neck 109 extending between proximal end 110 and a transition 111. The flexible neck 109 has a greater flexibility than the adjacent portion of the tubular body 108 distal to the transition 111. The flexible neck 109 may have a length of at least about 2 cm and often at least about 4 cm, but generally no more than about 20 cm or 10 cm or less.
The sidewall of the catheter body 108 within flexible neck 109 includes a helical coil 113 having adjacent filars spaced apart to both improve flexibility, and also allow visualization between adjacent windings of the coil. At least the flexible neck 109 includes a sidewall window such as the spaces between adjacent coil windings which may be in the form of an optically transparent outer tubular layer, such as any of a variety of optically transparent shrink tubing polymers. This allows visualization of clot through the side wall as it passes through the neck 109 before it enters the proximal handle. The transparent window on the larger catheter 108 also allows visualization of the distal tip of the inner catheter 152 as it passes the window. This may be facilitated by placing a visual marker on the distal end of the inner catheter 152 such as a colored annular band.
For example, in an implementation having a 24 French tubular body 108, the smaller tubular body 152 (e.g. 16 French catheter) may be provided with a visual indicium such as a white tip on the distal end, that can be visualized through the sidewall window as it passes through the flexible neck 109. The flexible neck 109 may also be provided on the catheter shaft 152.
The spring coil 113 may extend distally to a point of termination within about one or 2 cm of the transition 111, and, and one implementation, at the transition 111. Distally of the transition, the sidewall of tubular body 108 may include a tubular braid, importing greater stiffness and higher push ability than the helical coil 113.
The proximal end of the catheter may be provided with a rotation control such as a rotatable knob 115 which may be rotationally fixed to the catheter and rotatable with respect to the handle housing. This facilitates relative rotation between the catheter and the housing for any of the large or small bore catheters disclosed herein.
A central lumen extending through the tubular catheter body 108 is in communication with a flow path extending through the proximal handle 106 to a proximal access port 112. The flow path between the tubular catheter body 108 and the proximal access port 112 is preferably linear, to axially movably receive the second catheter 104 which may or may not be utilized in a given procedure. To accommodate the absence of second catheter 104 and seal the port 112, the proximal handle 106 is preferably provided with a homeostasis valve 114 such as a Thuohy-Borst valve.
A manifold switch 116 controls two way or three way a manifold valve (illustrated in
A filter assembly 120 includes housing 122 with a side wall 124, at least a portion of which includes a transparent window 126. Window 126 permits a viewing of the contents (e.g. aspirated clot) of a filter chamber 128, which contains a filter 130.
The filter assembly 120 is configured to place the filter 130 in the flow path between the tubular catheter body 108 and the aspiration tubing 118. Preferably the filter chamber can be closed to maintain negative pressure conveyed from a pump via aspiration tubing 118, or opened to permit insertion or removal of the filter 130. In the illustrated implementation, the filter assembly 120 is removably connected to the handle 106. A connector 134 such as a first thread on the housing 122 is releasably engageable with a complementary connector 136 such as a complementary thread on the handle 106. A vent (aperture) to atmosphere may be provided in communication with the filter chamber, to reduce foaming of blood in response to reduced pressure.
An implementation may include an integrated flow control module in the proximal handle 106. Thus, an adjustable flow regulator (not illustrated) may be positioned in the flow path, to enable controllable toggling of the aspiration between a low flow mode and a high flow mode. In the illustrated implementation, optional flow regulator is positioned downstream of the filter 130, and contained within the housing 122 of the filter assembly 120. A flow regulator control 132 is provided, to control the flow rate. Preferably, as has been discussed, the flow regulator is configured to regulate fluid flow through the flow path at a default low flow rate. Activation of the flow control 132 adjust the flow to the high flow rate mode. Flow control 132 may be a momentary button, slider switch, trigger, knob or other structure that is preferably defaulted to the low flow mode.
In any of the catheters disclosed herein, carrying the filter chamber 128 on the catheter or at least spaced apart from the remote vacuum pump and vacuum canister provides enhanced aspiration performance. The location of a conventional aspiration pump may be far enough away from the patient to require a length of aspiration tubing between the pump and the catheter to be as much as 50 inches or 100 inches or more. The pump typically includes an aspiration canister for blood collection. When aspiration is desired, a valve is opened to place the low pressure canister in communication with the catheter by way of the aspiration tubing, to aspirate material from the patient. But the length of the aspiration tubing operates as a flow restrictor, causing a delay between the time of activating the vacuum button and actual application of suction to the clot.
In some embodiments, the catheter handle 106 or 140 contains a filter chamber 128 for example, which is in communication with the vacuum canister on the pump by way of elongate aspiration tubing 118. The momentary aspiration control 117 is in between the filter chamber 128 and the catheter, which, in the default off position, allows the entire length of the aspiration tubing 118 and the filter chamber 128 to reach the same low pressure as the aspiration canister on the pump. The flow restriction between the pump canister 129 and the filter chamber 128 is greater than the flow restriction between the filter chamber 128 and the patient.
In an alternate configurations, 117 may be a vent to atmosphere which allows the clot canister to be evacuated. Element 142 can alternatively be an injection port such as for injecting contrast media, saline, or drugs.
Thus, the only remaining flow restrictor between a source of vacuum (filter chamber 128) and the patient is the relatively short aspiration pathway between the valve in the proximal handle and the distal end of the catheter. When the momentary aspiration control 117 is activated, the flow restriction and enclosed volume on the patient side of the filter chamber is low relative to the flow restriction and enclosed volume through aspiration tubing 118 on the pump side of the filter chamber 128.
This dual chamber configuration produces a rapid spike in negative pressure experienced at the distal end of the catheter upon activation of the aspiration control 117. The response time between activating the aspiration control 117 and realizing suction actually experienced at the clot is significantly faster and allows significantly higher initial flow than the response time realized in a conventional system having only a vacuum chamber located at the pump.
The spike of negative pressure experienced at the distal end of the catheter will fade as pressure equilibrium is reached between the filter chamber and canister. When the momentary aspiration control 117 is closed, the vacuum pump will gradually bring the pressure in the filter chamber 128 back down to the level in the vacuum canister at the pump.
A simplified fluid flow diagram is illustrated in
A blood reintroduction system 110′ can be positioned between the aspiration system 100 and the aspiration pump 50, as shown in
To facilitate the extraction of blood at the second outlet 104c′ (e.g., the extraction port) and to prevent air from being drawn into the syringe, the canister 102′ can include a tapering bottom portion. For example, the interior bottom portion of the canister 102′ can taper such as conically, narrow end towards the bottom portion, or otherwise inclined, to improve the flow of blood towards a low point of the canister 102′ in communication with the second outlet 104c′. Beneficially, this can improve the concentration of blood at or near the second outlet 104c′ allowing clinicians to extract blood from the canister 102′ via the second outlet 104c′. The canister 102′ can also include one or more support structures for maintaining an upright position or securing the canister to a patient and/or pole/bedrail. In some cases, the canister 102′ can include a downwardly extending skirt and/or legs to allow the canister 102′ to sit on a surface and remain in its upright position so that the outlet 104c′ communicates directly with the lowest point of the canister 102′. The body of the canister 102′ or support structures removably or permanently carried by the canister 102′ can also be shaped to conform to the shape of a patient's body. For example, a base of the canister 102′ can be contoured to sit across the top of a patient's legs. In some cases, the canister can include one or more support structures, such as a hook, for removably placing the canister on an IV pole and/or bedrail.
In some cases, the blood reintroduction system 110′ can include a flop tube (not shown). The flop tube can include weight on one end which can cause that end to gravitate towards a typically hemispherical bottom interior wall of the canister 102′ regardless of the orientation of the canister 102′. The weight of the flop tube can beneficially place the opening of the flop tube in contact with a bottom portion of the canister 102′ thus ensuring that the syringe draws fluids from a bottom a bottom portion of the canister 102′ and preventing the syringe from drawing air.
Blood extracted from the canister 102′ via the second outlet 104c′ can be reintroduced to a patient. For example, blood extracted by the extraction device, such as the syringe, can be injected directly or indirectly to a patient. In some cases, the blood can be injected into the vasculature of a patient. The blood can also be injected into a patient from the syringe to, for example, a venous line connected to a patient. In some cases, the blood reintroduction system 110′ can include a venous line (not shown) connected to a patient on one end and to the second outlet 104c′ on the other end. The venous line can beneficially facilitate fluid reinfusion into a patient by drawing blood collected inside the canister 102′ to the patient via the venous line. In such cases, it may not be necessary for clinicians to manually extract blood from the canister 102′ and reinfuse the blood to the patient. That is, blood collected inside the canister 102′ can be automatically reinfused by flowing though the venous line into the vasculature of a patient or a flow path into a vasculature of patient, such as flow path 32 which is described in relation to
Blood drawn into the canister 602 via the first aspiration tubing 618a can collect on a bottom portion of the canister 602. The second aspiration tubing 618b can place an upper air space within the canister 602 and an aspiration pump, such as aspiration pump 50 (as described in relation to
The interior surface of the canister 602 can include a coating to provide one or more of a variety of properties to the canister 602. In some instances, the coating may be configured to enhance visualization through at least a portion of the canister 602. The coating may be configured to inhibit blood accumulation or increase blood repellant properties. In some instances, the canister 602 may comprise a coating to inhibit foam formation during an aspiration procedure. The coatings may be located at least partially along an interior surface of the canister 602. The coating can be both hydrophobic and oleophobic. In some instances, the coating may have some hydrophilic features on a portion of the polymer to increase oleophobic properties.
The first aspiration tubing 618a and the second aspiration tubing 618b can include one or more valves. For example, the first aspiration tubing 618a and/or the second aspiration tubing 618b can include one or more stopcock valves 619. Opening and/or closing the stopcock valve 619 along the first aspiration tubing 618a and/or the second aspiration tubing 618b can beneficially allow users to control aspiration and/or the flow of blood through the first aspiration tubing 618a and/or the second aspiration tubing 618b. Opening the stopcock 619 can open the first aspiration tubing 618a and/or the second aspiration tubing 618b to atmosphere to facilitate withdrawal of blood by allowing venting of atmospheric air into the canister 602 regulate and/or equalize pressure while withdrawing blood via a syringe 620.
In some cases, the inlet 604a and the first outlet 604b can be positioned on a top portion of the canister 602. The inlet 604a and the first outlet 604b can be positioned on opposite ends of the canister 602. Positioning the first outlet 604b on a top portion of the canister 602 can beneficially prevent the first outlet 604b, which is in fluid connection with an aspiration pump, such as aspiration pump 50 which is described in relation to
The syringe 620 can be used to extract fluid 630 from the canister 602 via the second outlet 604c. This can beneficially allow users to withdraw fluids 630 (e.g., blood) collected inside the canister 602 for infusion into a patient without significant, or any, interruption in the aspiration procedure and/or any disconnection of any components of the blood reintroduction system 600. That is, a physician or user may simply engage the syringe 620 to the second outlet 604c at any point during the aspiration procedure to withdraw blood from the canister 602 and reintroduce the blood to the patient. This can allow blood to be withdrawn from the canister 602 while still applying aspiration to the canister 602 and/or any of the devices and/or components in fluid communication with the canister 602 (e.g., the first tubing 618a, the inlet 604a, an aspiration catheter, etc.). Positioning of the blood reintroduction system 600 within a sterile field can significantly reduce the risk of blood contamination prior to reintroduction of the blood into the patient.
Fluid 630 extracted from inside the canister 602 via the second outlet 604c can be reintroduced to a patient. For example, the fluid 630 extracted by the extraction device, such as the syringe 620, can injected directly or indirectly to a patient. In some cases, the fluid 630 can be injected into the vasculature of a patient. The fluid 630 can also be injected to a patient from the syringe 620 to, for example, a venous line connected to a patient. In some cases, the blood reintroduction system 600 can include a venous line (not shown) connected to a patient on one end and to the second outlet 604c on the other end. The venous line can beneficially facilitate fluid reinfusion into a patient by drawing fluid 630 collected inside the canister 602 to the patient via the venous line. In such cases, it may not be necessary for clinicians to manually extract fluid 630 from the canister 602 and reinfuse the fluid 630 to the patient. That is, fluid 630 collected inside the canister 602 can be automatically reinfused by flowing though the venous line into the vasculature of patient or a flow path into a vasculature of patient, such as flow path 32 which is described in relation to
In some cases, the blood reintroduction system 600 can include one or more filters. The one or more filters can be positioned upstream of the second outlet 604c, at the second outlet 604c, at the syringe 620, and/or along a flow path (e.g., a venous line between the second outlet 604c and the patient) before reinfusion of the fluid 630 to the patient. In some cases, the one or more filters can be positioned between a downstream opening of the second outlet 604c and an upstream internal space of the canister 602.
For example, the blood reintroduction system 600 can include a filter 640, as shown in in
Although reference is made to the filter 640 being positioned inside the cavity 606a of the base 606, the filter 640 can be positioned anywhere along a flow path extending from the inlet 604a to the second outlet 604. In some cases, the filter 640 can be positioned anywhere between the canister 602 and the vasculature of the patient. In some cases, the blood reintroduction system 600 can include more than one filter 640. For example, the system 600 can include a first filter positioned distal to the inlet 604a and a second filter proximal to the inlet 604b. The first and second filters can include the same or different filter ratings. For example, the first filter can include pores larger than the pores of the second filter. This can prevent clots and/or particles larger than a porosity of the first filter from reaching the canister 602. The use of two or more filters can beneficially prevent any solid material, such as a blood clots and/or thrombus, from reaching the second outlet 604c. In some cases, the first filter can be part or otherwise positioned within the handle 106 of the aspiration system 100 (as described in relation to
In some cases, a longitudinal axis of the second outlet 604c can incline from a plane defined by the base 606 at an angle. For example, a longitudinal axis L1 of the second outlet 604c and the base 606 can form an angle A1, as shown in
Like the blood reintroduction system 600, the blood reintroduction system 700 can include one or more filters. The one or more filters can be positioned upstream of the second outlet 704c, at the second outlet 704c, at a syringe, and/or along a flow path (e.g., a venous line between the second outlet 704c and the patient) before reinfusion of the fluid to the patient. In some cases, the one or more filters can be positioned between an outlet opening of the second outlet 704c and an internal volume of the canister 702. For example, the blood reintroduction system 700 can include a filter 740. The filter 740 can be positioned inside a cavity 706a of the base 706. In some cases, a shape and/or dimensions of the cavity 706a are larger than a shape and/or dimensions of the filter 740 to allow the cavity 706a to receive and secure the filter 740. The filter 740 can prevent solid matter, such as thrombus, collected inside the canister 702 from reaching the second outlet 704c. This can beneficially prevent solid matter from being extracted via the second outlet 704c using an extraction device, such as a syringe. The filter 740 can trap solid matter while allowing fluids (e.g., blood), to flow past the filter 740. In some cases, the second outlet 704c can include an extension tube 705 in fluid communication with the filter 740. The extension tube 705 can be sealed to one end of the filter 740, as shown in
In some cases, the second outlet 704c can extend from a base 706 at an angle. For example, a longitudinal axis L2 of the second outlet 704c and the base 706 can form an angle A2, as shown in
Like the blood reintroduction systems 600 and 700, the blood reintroduction system 800 can include one or more filters. The one or more filters can be positioned upstream of the second outlet 804c, at the second outlet 804c, at a syringe, and/or along a flow path (e.g., a venous line between the second outlet 804c and the patient) before reinfusion of the fluid to the patient. In some cases, the one or more filters can be positioned between a downstream opening of the second outlet 804c and an internal volume of the canister 802. For example, the blood reintroduction system 800 can include a filter 840. The filter 840 can be positioned inside a cavity 806a of the base 806. In some cases, a shape and/or dimensions of the cavity 806a are larger than a shape and/or dimensions of the filter 840 to allow the cavity 806a to receive and secure the filter 840. The filter 840 can prevent solid matter, such as thrombus, collected inside the canister 802 from reaching the second outlet 804c. This can beneficially prevent solid matter from being extracted via the second outlet 804c using an extraction device, such as a syringe. The filter 840 can trap solid matter while allowing fluids (e.g., blood), to flow past the filter 840. Like the blood reintroduction system 600, the blood reintroduction system 800 can include a cavity 822 positioned between the filter 840 and the second outlet 804c, as shown in
In some cases, a longitudinal axis L3 of the second outlet 804c and a base 806 can form an angle A3. Like the angle A2 of the blood reintroduction system 700, the angle A3 of the blood reintroduction system 800 can include a right angle relative to the plane of the base. For example, the angle A3 can be between about 90° and about 45°, between about 90° and about 75°, or between about 80° and about 70°. The angle A3 can ensure that the extraction mechanism (e.g., the needle) of the syringe can couple to the outlet port 804c on the cavity 822 without mechanical interference from the canister 802. This can beneficially allow the syringe to draw filtered fluid through the cavity 822 and prevent the syringe from drawing air.
Like the blood reintroduction systems 600, 700, and 800, the blood reintroduction system 900 can include one or more filters. The one or more filters can be positioned upstream of the second outlet 904c, at the second outlet 904c, at a syringe 920, and/or along a flow path (e.g., a venous line between the second outlet 904c and the patient) before reinfusion of the fluid (e.g., blood) to the patient. In some cases, the one or more filters can be positioned between an opening of the second outlet 904c and an internal space of the canister 902. For example, the blood reintroduction system 900 can include a filter 940. Unlike the filters 640, 740, and 840, of the blood reintroduction systems 600, 700, and 800, the filter 940 of the blood reintroduction system 900 can be positioned outside the canister 902. For example, the filter 940 can be positioned inside a canister connector 942. The canister connector 942 can extend from the base 906. The canister connector 942 can include a window 942a, such as a transparent side wall, to permit visualization of any debris trapped on an upstream surface of the filter membrane. In some cases, a shape and/or dimensions of the canister connector 942 are larger than a shape and/or dimensions of the filter 940 to allow the canister connector 942 to receive and secure the filter 940. The filter 940 can prevent solid matter, such as thrombus, collected inside the canister 902 from reaching the second outlet 904c. This can beneficially prevent solid matter from being extracted via the second outlet 904c using an extraction device, such as the syringe 920. The filter 940 can trap solid matter while allowing fluids, such as fluid (e.g., blood), to flow past the filter 940.
In some cases, a longitudinal axis L4 of the second outlet 904c and/or the canister connector 942, and the base 606 can form an angle A4, as shown in
A filter assembly 1140 is carried by and can be positioned at least partially inside the canister 1102. For example, the filter assembly 1140 can be positioned inside a canister connector 1152 at least partially formed by the canister 1102. In some cases, the canister connector 1152 can extend from the canister 1102. The base 1106 and the canister connector 1152 can form an acute angle similar or identical to angels A1 and/or A4, which are described in relation to
The filter assembly 1140 can also include a filter 1141. The filter 1141 can be positioned inside the filter housing 1142, as shown in
The cap 1144 can include a thread 1144a, as shown in
While the cap 1144 and the canister connector 1152 are illustrated with a threaded interlocking system, it will be understood that the cap 1144 and the canister connector 1152 may incorporate any suitable interlocking mechanism (e.g., an adhesive, snap-fit, interference fit, etc.) to engage the cap 1144 with the canister connector 1152. The interlocking mechanism can beneficially allow physicians and/or users to remove and replace the filter assembly 1140 and/or the filter 1141 if, for example, the filter 1141 gets clogged during use.
In some cases, the second outlet 1104c can include a valve such as a luer fitting. The second luer fitting can be secured to the cap 1144. Blood can be extracted from the canister 1102 via the luer fitting using an extraction device such as a syringe. The syringe can be similar or identical to syringes 620, and/or 920. The filter 1141 can prevent solid matter, such as thrombus, collected inside the canister 1102 from reaching the luer fitting. This can beneficially prevent solid matter from being extracted via the luer fitting using the extraction device. The filter 1141 can trap solid matter while allowing fluids (e.g., blood), to flow through the filter 1141 and into the extraction device.
In embodiments where the second outlet 1104c includes a luer fitting, the luer fitting can allow the second outlet 1104c to receive and secure other luer fitting. For instance, a syringe with a luer fitting can be connected and secured to the luer fitting of the second outlet 1104c. The luer fitting can beneficially allow for the precise control of withdrawal of fluids from the canister 1102. The luer fitting can also provide a secure connection to the syringe and/or tubing and prevent leaks at the second outlet 1104c. The luer fitting can include different sizes and dimensions to accommodate different syringes and/or tubing.
The filter 1141 allows absorption of fluids and extraction of the fluids using the extraction device (e.g., syringe) when the filter 1141 is in fluid contact with the fluids inside the canister 1102. To improve and maintain contact between the filter 1141 and the fluids collected inside the canister 1102, the distal end 1142b of the filter housing 1142 and the distal end of the filter 1141 can positioned at least partially in the low spot such as dip 1108 formed by the second portion 1107b of the floor 1107. The inclined surface of the first portion 1107a can facilitate flow of the fluids toward the dip 1108 formed by the second portion 1107b and allow the distal tip of the filter 1141 to contact the bottom-most part of the floor 1107. This can beneficially enhance contact between the distal tip of the filter 1141 and the fluids, thus allowing extraction of the fluids using the extraction device and preventing users from extracting air. The inclined first portion 1107a can allow any blood inside the canister 1102 to be immediately directed towards the dip 1108 where the filter 1141 is closest to the floor 1107.
A bottom edge of the filter 1141 can be transverse to a longitudinal axis of the filter housing 1142. In some cases, once the filter 1141 gets wet (e.g., the filter 1141 contacts the blood collected inside the canister 1102), it can absorb the blood collected in the canister 1102. This can beneficially allow the extraction device, such as a syringe, to withdraw blood from the filter 1141 even when only a portion of the filter 1141 is in contact with the blood inside the canister 1102. The proximity of the distal end of the filter 1141 to the dip 1108 reduces the amount of blood required for the filter 1141 to first contact the blood. In some cases, as little as 50 cc of blood may collect inside the dip 1108 before the blood contacts the distal end of the filter 1141.
A flow path extending between the dip 1108 and the second outlet 1104c can allow blood to collected at or near the dip 1108, flow through the filter 1141, and exit the canister 1102 via the second outlet 1104c. Physicians and/or users can extract blood from the canister 1102 using the syringe as long as any part of the filter 1141 is in contact with the blood collected in the dip 1108. The syringe can draw the blood absorbed by the filter 1141 through the sidewalls of the filter 1141 until the blood is drawn into the syringe via the second outlet 1104c. As blood is withdrawn using the syringe, any remaining blood inside the canister 1102 can flow to the dip 1108 where it can be absorbed by the filter 1141 and/or subsequently withdrawn using the syringe. This can beneficially prevent the blood from settling inside a portion of the canister 1102 where the blood may be prevented from being withdrawn using the syringe.
In any of the embodiments disclosed herein, blood can flow into the canister 1102 through an inlet aligned a top portion of the canister 1102. The blood can wash along the sidewall of the canister 1102. This can allow physicians and/or users to easily identify the presence of blood inside the canister 1102. The sidewalls of the canister 1102 can provide a smooth pathway (e.g., decrease sheer stress and/or improve laminar flow) for the blood to flow towards the floor 1107 which can beneficially prevent and/or decrease hemolysis. For example, the inlet 1104a can be oriented so that blood is directed to an interior of the sidewall of the canister 1102 as blood flows from the aspiration catheter into the canister 1102. This can allow a circumferential blood flow along the inter of sidewall. The circumferential blood flow can result in the blood flowing along the sidewall before eventually collecting on the floor 1107 of the canister 1107. The circumferential blood flow can beneficially minimize turbulence and/or splashes. In some cases, the flow of blood exiting the inlet 1104a can form a tangent relative to the interior of the sidewall.
Additional details of the filter assembly and related structures are illustrated in
The filter 130 is displaced downward with respect to a central longitudinal axis of the tubular sidewall 124, leaving the filter chamber 128 having a chamber height 129 at least as great as the inside diameter of a filter line aperture 330 leading to filter line 208. This allows clot to move from filter line 208 into the filter chamber 128 without restriction, and optimizes the volume of filter chamber 128 on top of the filter 130 for viewing through the window 126.
A connector 134 may be carried by the filter assembly 120, such as in the form of a bayonet mount, or other releasable attachment to the proximal handle housing. A first seal 332 such as an annular elastomeric ring may be provided between the tubular sidewall 124 and the complementary surface on the proximal handle housing.
A second vacuum aperture 328 is in communication with the first vacuum aperture 322 by way of the flow path 324. Second vacuum aperture 328 may be carried on an axially extending tubular projection 336 which may be removably received within a complementary recess on the proximal handle housing.
A second seal 340 such as an elastomeric ring may be provided surrounding the flow path 324, for providing a seal between the filter assembly and the proximal handle. In the illustrated implementation, the second seal 340 surrounds the tubular projection 336 and is configured to seal against an adjacent complementary surface on the proximal handle in the as mounted orientation.
Referring to
A complementary docking platform 350 is carried by the proximal handle, having complementary connector to connector 134 for rapid attachment and detachment of the filter assembly 120 from the proximal handle. In the illustrated embodiment, at least a first flange 352 may be received through an opening 354 on the filter assembly 120. Rotation of the filter assembly 120 moves the first flange into interference fit with a second flange 356 to secure the filter assembly 120 to the docking platform 350 on the proximal handle. Two or three or four or more similar flange and complementary opening pairs may be provided around the periphery of the components. In the illustrated implementation, the circumferential arc length of the flange and corresponding opening on one of the three pairs is greater than the other two pairs to function as a key, so that the filter assembly can only be secured to the docking platform in a single rotational orientation.
The docking platform 350 includes a filter line aperture 360 for communicating with filter line 208, and a vacuum line aperture 362 for placing the filter 130 in communication with a source of vacuum. The docking platform 350 may be connected to a two way valve 362 or a three way valve as is discussed elsewhere herein depending upon the desired functionality. The valve may carry a rotatable drive gear 304 to rotate the interior rotatable valve gate as is discussed in additional detail below. Alternatively, a lever or other control on the housing may be configured to rotate a shaft directly coupled to the rotatable part of the valve.
A valved flow path may also be provided for venting the filter chamber 128 directly to atmosphere. The valve may be opened such as by depressing a momentary button, which is biased in the closed direction. This can create an abrupt change in pressure at the distal end of the catheter, which may facilitate clot aspiration. This can also be used to discharge vacuum
Referring to
A steering dial 144 may be provided to place one or more steering wires under tension, to deflect a deflection zone near the distal end of the tubular body 152. A manifold switch 116 may be provided to control the flow of fluid as will be discussed below. The handle additionally comprises an aspiration control 117 such as a slider switch, for turning aspiration on or off. A max button 132 may be provided for delivering a momentary pulse of high aspiration rate as has been discussed.
Fluid flow through the thrombectomy system is controlled by manifold switch 116 (see, e.g.,
Patient line 202 may be placed in communication with a manifold line 204 by advancing the three-way valve 200 to a first position, such as to allow delivery of medications, contrast media or saline to the patient.
Adjustment of the three-way valve 200 to a second position can isolate patient line 202 and place the manifold in communication with the filter 206 via filter line 208. Activation of a vacuum pump will draw blood from the patient and through the filter 206 via vacuum line 210.
Further adjustment of the three-way valve 200 to a third position will place the manifold in communication with the vacuum line 210, such as to permit a saline flush of the filter 206. This third position may be eliminated depending upon the desired functionality.
One implementation of a suitable three-way valve 200 is illustrated in
In the rotational orientation of the rotatable gate 222 illustrated in
The third position is illustrated in
The foregoing selectivity may be achieved by spacing the three ports approximately 120 degrees apart around the circumference of the housing, to cooperate with the flow channel 224 end ports which are about 120 degrees apart around the circumference of the cylindrical gate 222. The gate 222 may be rotated within the housing 220 by a connector 236 extending through the housing 220 such as along the axis of rotation, and connected to a control 116 such as a rotatable knob, lever or slider switch with a rack and pinion drive assembly.
Each of the catheters disclose herein may be provided with a hemostasis valve on the proximal end, to allow selective closing of the central lumen to completely closed without any devices extending therethrough, from a sealed fit around devices of differing diameters such as a guide wire or a secondary catheter extending therethrough. One example of a suitable hemostasis valve is schematically illustrated in
Referring to
The flow path and tubular sidewall 254 extend between a first end 256 and a second end 258. First end 256 may be a port 112 (see, e.g.,
At least a portion 260 of the sidewall 254 is collapsible in response to external pressure. That portion 260 and optionally the full length of the tubular sidewall within valve 250 may be comprise a collapsible elastic tube such as silicone tubing, which is biased into an open lumen tubular configuration when unconstrained. A compression element such as filament 262 is configured to apply compressive force against the sidewall 254 to reduce the inside diameter of the flow path to provide a seal against itself (when completely closed with no devices extending therethrough) or against a device such as a guidewire or catheter extending therethrough. In the illustrated implementation, the filament 262 forms a loop 268 around the collapsible portion 260 of tubular sidewall 254. Retraction of a first tail portion 270 of the filament 262 away from the sidewall 254 constricts the diameter of the loop 268 thereby collapsing the portion 260 of the tubular sidewall as illustrated in
In the illustrated implementation, the first tail portion 270 of the filament 262 may be retracted by at least a first lever 264. Lever 264 may be connected to the frame 252 by a first pivot 266 and is attached to the tail portion 270 at an attachment point 272. Advance of the lever in a first direction places the filament under tension and reduces the inside diameter of the valve. Releasing the lever removes the tension and the collapsible portion 260 of the sidewall rebounds to its unconstrained, open lumen configuration.
In the illustrated implementation, a second lever 274 is attached to the frame 252 at a second pivot 276, and is attached to a second tail portion 278 of the filament 262. Each of the first and second tail portions may comprise a single filament or two or three or more parallel filaments. In the two filament configuration as illustrated, the filaments may be immovably secured to the lever, or may be a continuous filament, looped around a fulcrum 280. The loop 268 may comprise one or two or three or more revolutions around the tubular sidewall, depending upon the desired performance.
At least one lever 264 is provided with a spring 282 to bias the lever away from the tubular sidewall, constricting the inside diameter of the collapsible portion 260 into sealing engagement with a device extending therethrough, or to a completely closed configuration in the absence of a device. As illustrated, a second lever 274 may also be biased using the same spring or a second spring.
As illustrated in
Retraction of the tail portion 270 of filament 262 may alternatively be accomplished by winding the tail portion 270 around a rotatable spool such as a shaft or drum. Rotation of a knob or advance of a lever causes the spool to take up filament and collapse the sidewall.
An alternate configuration for the filament 262 is illustrated in
Compression of the first lever 264 and second lever 274 loosens the loop 268, allowing the lumen to resume patency. Releasing the levers allows the spring bias to reduce the diameter of the loop 268 as the first tail portion 270 and second tail portion 278 slide away from each other around the left and right fulcrums. Preferably, friction between the filament 262 and fulcrums are minimized, as by providing a lubricious oil such as silicone oil around the fulcrums at 280 and 272, as well as using Teflon braided line for the filament 262.
Various components of the aspiration system handle are schematically represented in context in
A steering mechanism 306 is provided to permit steering of the second catheter 152. Manually rotatable knob 148 allows manual rotation of a core wire and distal helical tip as has been discussed. The core wire axially movably extends across hemostasis valve 146. Alternatively, the core wire and tip (e.g., thrombus engagement tool 400) may be coupled to a motorized drive unit at the proximal end of the catheter system.
In certain implementations, an aspiration catheter such as a 16 French catheter is advanced transvascularly over a wire and/or through a larger diameter (e.g., 24 French aspiration catheter) to the treatment site. If the application of vacuum is not able to aspirate the clot into the 16 French catheter, an elongate flexible thrombus engagement tool may be advanced through the 16 French aspiration catheter, to facilitate retrieval of the clot.
Referring to
In one implementation illustrated in
Referring to
The helical thread 412 on this implementation may have a constant pitch throughout its length. The pitch may be within the range of from about 10 to about 20 threads per inch, or about 5 to about 10 threads per inch depending upon desired performance. Alternatively, the thread may have multiple pitches designed to engage, transport and grasp thrombus within the catheter lumen. A distal pitch may be less than a proximal pitch. The pitch may vary continuously along the length of the thread, or may step from a first, constant pitch in a proximal zone to a second, different pitch in a distal zone of the thread. The thread 412 may comprise a continuous single helical flange, or may have a plurality of discontinuities to produce a plurality of teeth or serrations, arranged helically around the core wire.
The side elevational profile or envelope scribed by the distal tip as it rotates may have a linear or nonlinear taper on one or both ends (e.g., football shaped) which provide varying diameter and thus clearance along its length from the generally cylindrical ID of the catheter lumen.
The maximum OD of the thread 412 is preferably smaller than the diameter of a sliding fit within the catheter lumen, and may generally be at least about 0.015 inches or 0.010 inches smaller than the catheter lumen ID. In some implementations, the Max OD of the tip may be significantly less than the inside diameter of the catheter lumen to allow more space for the thrombus, but still create significant grasping force via engagement of the helical threads with the thrombus. In one implementation, the maximum helical thread diameter is about 0.110 inches and the catheter lumen ID is about 0.275 inches (24F) (a 0.165 inch gap between the helical threads and catheter wall.
In certain applications, the Max OD of the tip is no more than about 35% or no more than about 40% or no more than about 60% of the ID of the catheter, to leave a substantial tip bypass flow path. Since this implementation does not have any centering structures for the tip 410 or shaft 402, the tip will normally be pushed to one side of the aspiration lumen. When a clot becomes lodged between the tip and the opposing wall of the catheter, manual rotation of the tip can engage the clot like a worm gear and either grasp the clot (e.g., by pinning it against the opposing catheter sidewall) for retraction or facilitate freeing the blockage and aid in ingestion of the clot into the catheter.
The profile of the tip 410 viewed along the axis of rotation may be circular, or may vary to create a non circular pattern around the axis of rotation. The tip as seen in an end elevational view thus exhibits a major diameter and a minor diameter. The minor diameter may be no more than about 95% or 90% or 80% or 70% of the major diameter, depending upon desired performance.
Referring to
The axial length of the advance segment 418 may be at least about 1 cm or 2 cm and in some implementations is within the range of from about 2 cm to about 4 cm. The axial length of the helical thread 412 along the longitudinal axis is typically within the range of from about 1 cm to about 5 cm and in certain implementations between about 2 cm and 3 cm.
The outside diameter of the advance segment 418 at distal tip 420 is generally less than about 0.024 inches, or less than about 0.020 inches and, in one implementation, is about 0.018 inches. The maximum outside diameter of the advance segment 418 and helical thread 412 may be within the range from about 0.020 to about 0.045 inches, and, in one implementation, is less than about 0.040 inches, such as about 0.035 inches. The advance segment, helical thread and trailing segment of the tip 410 may be molded over the flexible shaft 402 using any of a variety of polymers known in the catheter arts.
Referring to
In one implementation, the maximum OD of the thread 412 exceeds the maximum OD of the advance segment 418 by at least about 15% or 25% or 30% or more of the OD of the advance segment 418, to facilitate crossing the clot with the advance segment 418 and engaging the clot with the thread 412. The thread pitch may be within the range of from about 0.75 to about 0.30, or within the range of from about 0.10 and about 0.20, such as about 0.14 inches.
Preferably, the maximum OD of the tip 410 is less than about 60% or less than about 40% of the aspiration catheter ID at the distal end of the catheter, and may be within the range of from about 35% to about 55% of the catheter ID. In certain implementations, the maximum OD of the tip 410 may be within the range of from about 0.044 inches to about 0.041 inches within a catheter having a distal end ID within the range from about 0.068 inches to about 0.073 inches.
Depending upon the clinical application, it may be desirable to control the extent to which, if any, the distal tip 410 can extend beyond the distal end of the catheter. For example, distal extension of the distal end of the helical tip beyond the distal end of the catheter may be limited in some implementations to no more than about 5 mm or 3 mm or 1.5 mm or 1.0 mm or less. In other clinical environments the distal tip 420 may be permitted to extend at least about 2 cm or 3 cm and preferably as much as 4 to 8 cm beyond the catheter, but generally will be limited to extend no more than a preset distance such as 12 cm or 8 cm or 5 cm beyond the catheter depending upon desired performance. In one implementation, distal advance of the tip 410 is limited so that the distal end is within 2 cm or within 1 cm or no more than 0.5 cm in either the distal or proximal direction from the distal end of the aspiration catheter.
Distal advance of the tip 420 may be limited by providing mechanical interference at the desired distal limit of travel. In one implementation, a distal stop surface 440 on the handle 408 provides an interference engagement with a complementary proximal surface carried by the aspiration catheter through which the thrombus engagement tool 400 is advanced. Alternatively, a distal engagement surface can be carried anywhere along the length of the thrombus engagement tool 400, for sliding engagement with a complementary proximally facing stop surface carried by the catheter. Additional details may be found in U.S. patent application Ser. No. 17/036,258 filed Sep. 29, 2020 and entitled Embolic Retrieval Catheter, which is hereby expressly incorporated in its entirety herein by reference.
The limit on distal advance of the helical tip may include a first configuration in which distal advance is limited to a first position proximate the distal end of the evacuation catheter to prevent injury to the vascular wall. Upon a user initiated adjustment, the helical tip may be advanced to a second position farther out of the distal end of the catheter such as for inspection and cleaning purposes. This adjustment of the limiting mechanism may be locked out following cleaning or inspection, to limit distal travel to the first position to prevent an undesired degree of exposure of the helical tip element when the system is within the patient's vasculature. Any of a variety of movable interference levers of pins may be engaged to limit travel to the first position, or disengaged to allow travel to the second position.
Referring to
In general, the pitch of thread 412 may be within the range of from about 0.07 to about 0.11, and in one embodiment, is about 0.09. The width of the thread 412 measured along an axis that is perpendicular to a face of the thread may be within the range of from about 0.009 to about 0.04, and, in one embodiment, is about 0.02. The greatest major diameter of the thread 412 may be at least about 10%, or at least about 15%, or at least about 20% greater than the diameter of the proximal hub end of the tip 410 surrounding the cavity 442. In one implementation, the outside diameter of the proximal hub is about 0.090 inches and the outside diameter of the thread 412 is about 0.110 inches. The actual length of the tip 410 including the proximal hub may be within the range of from about 0.2 inches to about 0.8 inches and in some implementations within the range of from about 0.4 inches to about 0.6 inches.
The tip 410 may be manufactured in accordance with any of a variety of techniques known in the art, such as machining, etching, additive and/or subtractive processes. In one implementation, the tip 410 is molded from a polymer such as PEBAX, which may be a 55 D hardness. The PEBAX may include a radiopaque agent, such as bismuth sub carbonate, present in the range of from about 50% to about 70% by weight.
Any of the tip dimensions and configurations disclosed herein may be re-combined with any of the other tip dimensions, configurations, drive shafts and associated structures depending upon the desired clinical performance.
Referring to
A proximal exit port 494 in communication with the dilator guidewire lumen is oriented along the longitudinal axis of the dilator handle 480, such that a guide wire extending out of the exit port 494 lies along the first gripping surface 488. This allows a clinician to pin the guide wire to the gripping surface 488 using a finger such as a thumb, thereby enabling the dilator and the guide wire to be moved as a unit using one hand.
The dilator may be removably secured to the catheter such as by a retention clip 496 carried by the proximal end of the handle. A release such as a button or deformable interference snap fit may be provided to unlock the dilator handle from the housing, enabling the dilator to be proximally withdrawn from the catheter. In the illustrated implementation, a retention surface such as a proximal surface of a retention ring 497 carried by proximal end 486 of the body 482 provides an interference fit with the retention clip 496. This combines the dilator and handle/catheter into a single system. The paddle may be released from the retention clip by depressing at least a first button 506 and as illustrated also a second button 508 carried on the upper and lower sides of the retention clip housing, and proximally withdrawing the paddle.
This is the same connection and release dock for use with a thrombus engagement tool such as engagement tool 400 discussed in connection with
Once the distal limit has been released, the tip 410 may be distally advanced no more than about 4 cm and generally about 1 cm to 2 cm beyond the distal end of the catheter. This is intended to be accomplished once the thrombus engagement tool has been withdrawn from the patient, to allow visual inspection of the tip 410.
The engagement tool 400 may also be proximally retracted within the catheter, typically for less than about 3 cm or less than about 2 cm, and may be provided with a spring bias to return to approximate axial alignment between the distal end of the tip 410 and the distal end of the catheter.
A hemostasis clamp 500 may be provided, to hold the hemostasis valve open such as during shipping, or during the advance or withdrawal of devices therethrough. The hemostasis valve is opened by depressing at least a first control button, and in the illustrated implementation first and second control buttons positioned on opposing sides of the handle. The hemostasis clamp comprises a generally U shaped body 502 having a first arm 504 configured to depress a first button, and a second opposing arm (not illustrated) configured to depress a second button on an opposite side of the handle. The hemostasis clamp 500 may be removably retained on the handle by a friction fit, or an interference fit between the handle and the body which can be overcome by plastic deformation as the body is pulled away from the handle to release the hemostasis control buttons.
Referring to
This catheter-cannulated rail-guidewire assembly is intended to easily track through anatomical challenges more easily than the catheter. The catheter-rail-guidewire assembly then acts as a first stage of the catheter delivery system and enables the large diameter catheter or catheter system to be inserted and independently advanced over this first stage into a blood vessel (e.g. the femoral vein) percutaneously over a guidewire and advanced through potentially tortuous vasculature to the remote target location of interest without requiring advanced skills or causing kinking of the catheter.
The cannulated rail 561 may comprise a soft flexible cylindrical body having a guidewire lumen with a diameter of no more than about 0.040″ and an outside diameter no less than about 0.025″ or about 0.010″ smaller than the inner diameter of the large diameter catheter. Thus the wall thickness of the cannulated rail 561 is typically at least about 0.010″ less than the radius of the large diameter catheter and in some implementations at least about 0.120″ or more, depending upon the size of the annular space between the inside diameter of the catheter and the outside diameter of the guidewire.
The cannulated rail 561 may have an elongated tapered distal tip 562 that may project beyond the distal end 554 of the catheter 560. The thick sidewall of the cannulated rail 561 may comprise one or more flexible polymers, and may have one or more embedded column strength enhancing features such as axially extending wires, metal or polymeric woven or braided sleeve or a metal tube, depending upon the desired pushability and tracking performance along the length of the dilator.
Optionally, the proximal segment of the rail or dilator which is not intended to extend out of the distal end of the catheter may be a structure which is not coaxial with the guidewire, but a control wire which extends alongside the guidewire in the catheter and allows the distal tubular telescoping segment of the rail or dilator to be retracted or extended. (analogous to rapid exchange catheters) without the entire length of the rail structure being over the wire. This allows removal or insertion of the rail or dilator over a shorter guidewire because of the shorter coaxial segment tracking over the guidewire.
Catheter 560 may be provided with a proximal hub 520, having a port for axially movably receiving the rail 561 therethrough. The hub 520 may be provided with an engagement structure such as a first connector 522 for releasably engaging a second complementary connector 524 on a hub 526 on the proximal end of the rail 561. First connector 522 may comprise an interference structure such as at least one radially moveable projection 530, for releasably engaging a complementary engagement structure such as a recess 532 (e.g., an annular ridge or groove) on the hub 526. Distal advance of the rail 561 into the catheter 560 causes the projection 530 to snap fit into the recess 532, axially locking the catheter 560 and rail 561 together so that they may be manipulated as a unit.
The dilator is inserted through the hemostasis valve in the hub 520 of a large bore (e.g., 24F) catheter 560 and advanced through the catheter until the retention clip on the dilator hub 526 or catheter hub 520 snaps into the complementary recess on the other hub. In this engaged configuration, an advance segment along the flexible distal end of the 24F rail dilator 561 will extend at least about 5 cm or 10 cm, and in some implementations at least about 15 cm or 20 cm beyond the distal end 554 of the 24F catheter 560. The rail dilator and 24F catheter system are thereafter distally advanced over a previously placed guidewire and into the introducer sheath.
The dilator and catheter combination differentiate over prior systems both because of the flexibility of a distal zone of the dilator and greater length of the dilator than the corresponding catheter. Typically, a dilator is a uniform stiffness and length-matched to its catheter, with only a short atraumatic tip of the dilator extending beyond the distal end of the catheter. The dilator has a supportive proximal end and a flexible distal end, with a total dilator length much longer than the catheter 60 to enable, as an example, the following procedure.
In use, a guidewire 570 such as an 0.035″ guidewire is advanced under fluoroscopy using conventional techniques into a selected vessel. The cannulated rail 561, optionally with the catheter 560 mounted thereon, is loaded over the proximal end of the guidewire 570 and advanced distally over the wire until the distal end of the rail is in position at the target site.
The 24F catheter 560 is thereafter unlocked from the rail 561 and advanced over the rail 561 to the desired site, supported by the rail 561 and guidewire 570 combination. Because the uncovered advance section of the rail has already traversed the challenging tortuosity through the heart, the catheter 561 now just slides over the advance section of the rail for easy passage to the final target location. The supportive proximal zone and flexible distal advance section of the rail enables ease of delivery through the most challenging anatomy in, for example, a PE procedure going from the vena cava through the tricuspid and pulmonary valves of the heart into the central pulmonary artery without concern about damaging the tissue (atraumatic, flexible tip) or damaging the dilator (high kink resistance due to flexible, high wall thickness “solid” dilator construction.
The cannulated rail 561, or the cannulated rail 561 and the guidewire 570 combination, may thereafter be proximally withdrawn, leaving the large bore catheter 560 in position to direct a procedure catheter such as any of the aspiration catheters disclosed elsewhere herein to the target site.
Referring to
The core dilator 568 inside the SD catheter 541 and tubular dilator 570 between the two catheters may have an interlocking feature to create a single (SD+LD) catheter+(core+tubular) dilator system. For example, complementary connectors may be provided on hubs on the proximal ends of the system components.
The single (SD+LD) catheter+(core+tubular) dilator system may be pre-assembled and detachably interlocked at the proximal hub. Additional tubular dilators having a series of outside diameters and wall thicknesses may be provided such that the SD catheter may be used in combination with different diameter LD catheters. A LD catheter may be used with different SD catheters by providing tubular dilators having the same OD but a series of different inside diameters. The core+tubular dilators may simply be pulled proximally to withdraw both dilators as a single system, or the tubular dilator may be configured with a tab or handle at the proximal end and a slit, scoring, perforation or other mechanism so as to split, peel, or tear it along the longitudinal axis during withdrawal to allow the tubular dilator to peel from the SD catheter as it slides proximally out of the space between the LD and SD catheters.
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