Patent Application
20250107812
All publications and patent applications mentioned in this specification are herein incorporated by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.
During medical procedures, especially procedures to be performed within the vasculature, the interventional or diagnostic medical device often has to be navigated through long and tortuous anatomy to reach the site of interest. This complicated navigation and resulting pathway to the treatment site requires highly flexible catheters, which typically results in poor control of the interventional or medical device once treatment is attempted at the destination. There are different optimal stiffnesses for the different activities of navigation and treatment. Heretofore, most catheter designers have tried to solve the problem of balancing stiffness for navigation and for treatment by creating devices whose stiffness is a compromise between those different activities.
Most transcatheter procedures rely on the use of a pre-placed guidewire to direct and navigate the catheter to the desired anatomy. For example, prior to deploying a stent in the coronary artery, a guidewire is advanced through the lesion to serve as a guide for the catheter carrying the stent. However, the use of guidewires may complicate these procedures, requiring extra steps, and may not provide appropriate stability and support when performing operations within the vasculature. Guidewires may also displace the catheter being guided, particularly when navigating through tortuous anatomy. Guidewires may need to be ‘swapped’ for sequentially different stiffness guidewires, which adds time, risk and cost. Guidewire displacement, including losing guidewire position, can affect the ability to place the catheter in the correct position and can significantly extend procedural difficulty, risk, and duration and may lead to complications and iatrogenic injury.
Moreover, guidewires and guide catheters are often not effective for large bore catheters (e.g., large bore catheters suitable for treating pulmonary embolisms) because the large bore catheter may not easily track over the guidewire through tortuous anatomy (e.g., through the right atrium, the tricuspid valve, the right ventricle, the pulmonary valve, and through the pulmonary bifurcations). These larger bore catheters can be quite stiff, which, when navigated amongst tortuous anatomy, create stored energy which can be released unpredictably, causing procedural uncertainty and potentially dangerous complications including iatrogenic injury. In general, stiffer catheters require stiffer guidewires, which have more clinical risks—including perforations—as compared to more flexible guidewires.
A catheter that can be placed in the anatomy in a flexible condition may be better able to conform to the anatomy. Once rigidized, the anatomical pathway is preserved, protecting the adjacent anatomy by limiting forces that straighten the access. In one example, a pathway developed by an access catheter may begin in a state of anatomical conformation, but subsequent instruments placed within the access catheter may increase the stiffness and straighten the sheath and adjacent anatomy. Isolating and preserving the anatomical pathway reduces the potential for iatrogenic injury and hemodynamic complications associated with impingement of certain anatomical structures like heart valves.
Vascular obstructions (clots) may be removed with multiple devices, including mechanical removal, hydraulics (pressurized fluid streams) and by aspiration. Aspiration systems apply vacuum along a lumen from a proximal low-pressure source (for example, a vacuum pump) to a distal opening. Along the luminal path, systems typically incorporate features such as valve(s), gage(s), disconnect(s), flush port(s), guidewire access port(s), clot capture(s), blood capture, filter(s), and system(s) for blood re-infusion. These lumens may be constant bore, or they may have regions that expand, including distally, to capture larger clots more easily, and to increase the local vacuum suction area. The lumens may be open bore, or they may have elements therewithin that serve to process, chop, dissolve, macerate, cut, slice, or otherwise reduce the clot's local cross-sectional area, such that it is more easily transported from its distal input to its proximal output.
In some cases, other, more difficult or complicated treatments, are required. For example, pulmonary embolism treatment may require thrombolytics, which may be expensive, may have potentially deadly complications, may require an ICU stay, and are not particularly effective for larger or older clots. In some cases pulmonary embolism treatment may require surgery, which may be traumatic and expensive, including a sternotomy and bypass, and may require an extended stay in the hospital, and prolonged recovery.
There is a need for methods and apparatuses that may provide a safer and more reliable pathway to internal treatment sites, and that may allow enhanced treatments once at the site.
Described herein are methods and apparatuses, including systems and devices, and in particular catheters and associated components, that may be used to provide access and support to one or more cardiovascular procedures, including in particular, described herein are methods and apparatuses to remove material (e.g., clot material) from a vessel. For example, described herein are rigidizing aspiration sheath catheters that are adapted for use within a subject's vasculature (e.g., blood vessels, heart, etc.). As used herein vascular may include any vascular region of the body, including, but not limited, to peripheral, neurovascular, etc. These apparatuses, e.g., rigidizing aspiration sheath catheters, may include an integrated valve (e.g., hemostasis valve region) to prevent or limit blood loss during the procedure without interfering with the ability of the apparatus to rigidizing/de-rigidize. These apparatuses may be sized and shaped for insertion into the vasculature. The rigidizing aspiration sheath catheters described herein may be converted between one or more flexible states that may be readily navigated through even a tortuous anatomy, and one or more more-rigid states, in which the shape (including any bends or curves) of the rigidizing aspiration sheath catheter is locked in position. Intermediate states may also be useful at certain times during the procedure. As used herein, the flexible state may be highly flexible and the rigid state is generally more rigid than the flexible state; in some examples the rigid state may be highly rigid.
The rigidizing aspiration sheath catheters described herein may be configured to apply aspiration (e.g., suction) directly through the lumen of the rigidizing aspiration sheath catheter and/or they may be configured to receive an aspiration catheter (which, in some examples, may or may not also be rigidizing). The rigidizing aspiration sheath catheters described herein may be adapted to locking or coupling to a distal end of a suction line, using a universal coupling, e.g., mating attachment connector, that mates with a mating attachment at a distal end of vacuum line; the same mating attachment may lockingly couple with a separate aspiration catheter that may be used with, including inserted into, a rigidizing aspiration sheath catheter. In some cases an aspiration catheter (or other device) may be inserted into the lumen of the rigidizing aspiration sheath catheter while still allowing aspiration to be applied through the lumen of the rigidizing aspiration sheath catheters. For example, the apparatus may include an aspiration line that engage with the proximal end of the rigidizing aspiration sheath catheters including the hemostasis valve to allow insertion (and form a seal around the inserted) aspiration catheter or other device.
The apparatuses described herein may address the problem of balancing different stiffnesses for navigation and for treatment by configuring and using devices or systems that may dynamically modulate their stiffnesses (‘dynamically rigidizing’ or ‘dynamically stabilizing’), from high flexibility to high stiffness, throughout the procedure, potentially as a function of location along the device shaft, with a fast, facile, and indefinitely large number of transitions between these variable stiffness states. As mentioned above, these apparatuses may have significant advantages as compared with standard catheters that are not dynamically rigidizing, and typically have a set, fixed stiffness, though those fixed stiffness values can vary by zone (typically the zones change along the catheter's length). The dynamically rigidizing apparatuses (including but not limited to dynamically rigidizing catheters and other components) described herein can have regions that are selectively rigidized, or the entire shaft can be rigidized or made flexible as one cohesive entity. A dynamically rigidizing catheter can be configured to have a substantially lower proximal stiffness than a typical catheter, which can be advantageous as the proximal zone navigates through anatomy that can be tortuous, calcific, and, in some instances, can extend through atrium, ventricles, and valves. In these instances, lower baseline stiffness puts lower load on localized anatomical features.
In general, the methods and apparatuses described herein are particularly useful for vascular indications, including cardiovascular, peripheral vascular, cerebrovascular, neurovascular, pulmonary vascular, thoracic vascular, abdominal vascular, lymphatic vascular, renal vascular, and/or genitourinary vascular. The rigidizing aspiration sheath catheter may be dynamically rigidized, e.g., switched between a rigid state and a flexible state. The rigidizing aspiration sheath catheter may also include a hemostatic valve region at the proximal end. The hemostatic valve region may be integrated into the rigidizing aspiration sheath catheter. In some examples the rigidizing aspiration sheath catheter may be rigidized using positive pressure; alternatively in some examples the rigidizing aspiration sheath catheter may be rigidized using negative pressure. In some examples the rigidizing aspiration sheath catheter may be rigidized by both negative and positive pressure.
Also described herein are aspiration catheters (which may be rigidizing or non-rigidizing), a suction line, including an in-line vacuum activation valve and a clot capture chamber. All of some of these components may be used together, e.g., as part of system, or each of them may be used separately and may be configured to include elements of particular use in removing clot material.
The apparatuses and methods described herein may be used for aspiration of clot material from any region of the vasculature, including (but not limited to) pulmonary embolism, peripheral (e.g., arterial embolism), central (e.g., cerebral thrombus), etc., including treatment of stroke.
The aspiration of clots can involve removal of blood. The blood must be captured, and in some cases the blood must be returned to the patient. The present invention contemplates methods to capture, store and return blood to the patient. These include the use of filters and containers that are capable of separating blood in a sterile field. The system also anticipates the use of standard cardiotomy reservoirs. Cardiotomy reservoirs are indicated for use in cardiopulmonary bypass circuits during surgery. Intended uses include an air-fluid separation chamber, a temporary storage reservoir for priming solutions, filtration of particulate materials (clots, blood cell aggregates, etc.). Design accommodations in the present system would allow these reservoirs to be uniquely adapted to an aspiration embolectomy system.
In general, the methods and apparatuses described herein may provide superior control of the catheter or catheters within the vasculature by using dynamic rigidization. For example, a rigidizing aspiration sheath catheter may be positioned at or near a target location within the body in the flexible configuration (or by shifting between a rigid and flexible state), but may be rigidized to provide stability to other components that may pass through and/or extend from the apparatus. These methods and apparatuses may be used with a guidewire, e.g., to help position and/or navigate the catheter, however it may be preferable to operate these apparatuses without the use of a guidewire. Thus, these methods and apparatuses may be used without a guidewire, as the position of the catheter may be maintained by rigidizing the rigidizing aspiration sheath catheter. Thus, the rigidizing aspiration sheath catheter may be both a conduit for delivery and/or removal of material within the vasculature and may provide a stable platform for performing all or part of the procedure, including clot material and further navigation.
The systems described herein, which may include the rigidizing aspiration sheath catheter, one or more additional catheters (e.g., aspiration catheters), rigidizing pressure source (e.g., insufflator, etc.), and vacuum line components (e.g., vacuum activation valve, clot capture chamber, etc.) may be configured to remain within the sterile field during a medical procedure using these apparatuses. For example, the rigidizing aspiration sheath catheter may be positioned within the body and used for multiple introductions and removal steps, typically without requiring the use of a guidewire. Aspiration without a guidewire enables larger luminal area (and therefore greater suction), it reduces guidewire risks, and enables for smoother clot transit, because the clot does not need to shear relative to the wire. This may allow the system to be operated within the limited sterile filed during the entire procedure.
Because a rigidized cannula creates a fulcrum at its tip, the behavior of otherwise flexible aspiration catheters or other flexible instruments is altered accordingly. Unlike a standard system that must be navigated and controlled from the access site (e.g. femoral artery), a device that is manipulated within a rigidized cannula has different control dynamics. The navigable portion of a flexible device is shortened, leading to improved local control. In addition, because of the repositioned fulcrum, the tip of the rigidizing cannula can be used as a pivot point. In this case, a tensioning member within the flexible device can be tensioned to cause the flexible device to flex at the fulcrum. Since the flexible device can be moved in and out of the device, the pivot point moves accordingly. A tensioning member within the flexible device can alter the orientation of the tip thereby improving its navigability.
A tensioning member in the flexible instrument is controlled by an actuator located near the handle of the instrument.
In general, these methods and apparatuses may be used as part of any appropriate medical procedure, in particular vascular procedures, such as, but not limited to, clot removal from the pulmonary vasculature, neurovasculature, coronary vasculature, or peripheral vasculature.
For example, described herein are apparatuses including one or more rigidizing aspiration sheath catheter. A rigidizing aspiration sheath catheter may include: an elongate flexible body comprising a plurality of layers, including a rigidizing layer and a compression layer (e.g., a bladder layer) that is configured to transition the rigidizing layer between a flexible state and a rigid state, and a lumen extending through the elongate flexible body; and a hemostasis valve region extending proximally from the elongate flexible body, the hemostasis valve region comprising a housing having a central bore that is continuous with the lumen, and comprising an annular seal within the central bore and at least one actuator movable coupled to the housing and configured to open and close the annular seal or to seal around a device positioned within the central bore, wherein the at least one actuator is sized and shaped to be used by one hand of a user.
The elongate flexible body may be configured to rigidize along all or portion of the length of the body. The elongate flexible body may generally be an elongate tubular body, and may be any appropriate length (e.g., between 0.5 m and 2 m, between 0.7 m and 1.5 m, etc.), and any appropriate outer diameter (e.g., between 4 French and 35 French, between 10 French and 28 French, between 20 French and 30 French, etc.). The elongate flexible body may be coated inside or outside with a lubricious (e.g., hydrophilic) coating or a hydrophobic coating (for example, parylene).
As will be described in greater detail here, the elongate flexible body may include a plurality of layers, including one or more support layers. For example, the plurality of layers may comprise an inner and/or outer wound coil layer. The coil wound layer may support the rigidizing layer(s) and/or may be configured to withstand the application of suction through the lumen.
Any of the rigidizing apparatuses, including the rigidizing aspiration sheath catheters and (in some examples) the aspiration catheters, described herein may include rigidizing layers or regions that engage with a compression layer (which may be or may include a bladder, e.g., “bladder layer”) that applies force to the rigidizing layer to rigidize the rigidizing layer or in some cases to de-rigidize (e.g., release from rigidization) the rigidizing layer. In some examples, these rigidizing apparatuses may include a rigidizing layer that could include a braid, knit, woven, chopped segments, randomly distributed or randomly oriented filaments or strands, engagers, links, scales, plates, segments, particles, granules, crossing filaments, or other materials forming the rigidizing layer. For example, the rigidizing layer may comprise multiple strand lengths or strand segments that cross over each other (e.g., as part of a braid, knit, woven, etc.); the compression layer may apply force to drive the crossing strand lengths or strand segments against each other. Although many of the examples shown herein are braids, any of these apparatuses may instead or in addition include a general rigidizing layer comprising crossing strand lengths or strand segments. The examples of rigidizing apparatuses described herein may use positive pressure and/or negative pressure (vacuum) to selectively and controllable rigidize. The examples of rigidizing apparatuses described herein may use pressure (positive pressure) together with negative pressure (vacuum), for example, by ‘pushing’ with positive pressure on one side of a membrane, and ‘pulling’ with vacuum on the other side of a bladder.
In general, the rigidizing aspiration sheath catheters described herein may include a lumen, which may be central or may be offset, that is configured to allow passage of a guidewire, a dilator, contrast, a divided lumen (‘double lumen’), and one or more additional devices (e.g., a suction catheter). In some examples the rigidizing aspiration sheath catheters described herein include a lumen that includes a lubricious internal coating or layer, and/or is formed of a lubricous material, such as a hydrophilic material. The lumen of the rigidizing aspiration sheath catheters may be any appropriate size (e.g., inner diameter). For example, the rigidizing aspiration sheath catheters may have an inner diameter that is between about 4 French and 35 French, between about 10 French and 20 French, between about 12 French and 18 French, etc. The inner diameter may be substantially uniform along the length of the lumen. In some examples the inner diameter may include one or more narrowing (tapered) regions along the length. For example in some examples the distal end region of the lumen may be conical, cone-shaped, or tapered. The geometric change may be tapered towards a larger diameter, or towards a smaller diameter. This geometric change may be a stable geometry, or it may be a compressible or collapsible geometry, for example, a nitinol-based conical structure that has an overlaid membrane “skin.”
The proximal end of the lumen of the rigidizing aspiration sheath catheter may be continuous with the central bore of the hemostasis valve region. Thus, the hemostasis valve region may generally seal off the entrance into the lumen of the rigidizing aspiration sheath catheter. The hemostasis valve region may be integral with the proximal end of the rigidizing aspiration sheath catheter and may be adapted for use with the rigidizing aspiration sheath catheter. For example, the hemostasis valve region may operate as a handle region the proximal end of the rigidizing aspiration sheath catheter and may include one or more controls for operating the rigidizing aspiration sheath catheter, allowing easy and intuitive operation of the rigidizing catheter. For example, the one or more actuators (and preferably a pair of actuators) for opening and/or closing the annular seal of the hemostasis valve region may be on the housing of the hemostasis valve region. The one or more actuators may be levers, and may be sized for hand-held operation. One or more controls for controlling rigidization, e.g., turning on/off pressure for rigidizing the elongate flexible body by applying pressure (positive or negative pressure) to the compression (e.g., bladder) layer, may be located on or adjacent to the housing of the hemostasis valve region. In some examples, the rigidizing aspiration sheath catheter may include a pressure inlet coupled to the housing that is configured to receive positive or negative pressure to transition the rigidizing layer between the flexible state and the rigid state. In some examples the hemostasis valve region comprises a bladder adapter configured to allow communication between a pressure source and the bladder layer to control rigidization of the elongate flexible body.
As mentioned, any of the rigidizing aspiration sheath catheters described herein may be configured to apply suction through the lumen of the rigidizing aspiration sheath catheter. In some cases the rigidizing aspiration sheath catheter may include a mating attachment connector proximal to the hemostasis valve region and configured to lockingly engage with a mating attachment of a suction line. This mating attachment connector may be a universal connector that is similar, or identical to, the mating attachment connector of the aspiration catheter. Thus, the same suction line may be attached (swapped between) the aspiration catheter and the rigidizing aspiration sheath catheter. Alternatively in some examples, the suction may be applied to both the rigidizing aspiration sheath catheter and an aspiration catheter within the lumen of the rigidizing aspiration sheath catheter (e.g., around the aspiration catheter).
Any of the rigidizing aspiration sheath catheters described herein may include an atraumatic tip at the distal end of the rigidizing aspiration sheath catheter. For example, the distal end (tip) region) may be formed of a relatively soft (e.g., low durometer) material and may be rounded.
As mentioned, the rigidizing aspiration sheath catheters described herein may be configured to rigidize by the application of pressure. For example, the application of positive or negative (vacuum) pressure. In some examples the elongate flexible body may be configured to transition from the flexible state to the rigid state upon application of positive pressure. In some examples the elongate flexible body is configured to transition from the flexible state to the rigid state upon application of negative pressure. In some examples the elongate flexible body is configured to transition from the flexible state to the rigid state upon application of negative pressure to one side of a bladder simultaneous with the application of positive pressure to the other side of a bladder.
For example, a rigidizing aspiration sheath catheter may include: an elongate flexible body comprising a plurality of layers, including a rigidizing layer and a compression layer that is configured to transition the rigidizing layer between a flexible state and a rigid state, and a lumen extending through the elongate flexible body; and a hemostasis valve region extending proximally from the elongate flexible body, the hemostasis valve region comprising a housing having a central bore that is continuous with the lumen, and comprising an annular seal within the central bore and at least one actuator movable coupled to the housing and configured to open and close the annular seal or to seal around a device positioned within the central bore, wherein the at least one actuator is sized and shaped to be used by one hand of a user; and a mating attachment connector proximal to the hemostasis valve region and configured to lockingly engage with a mating attachment of a vacuum line to apply suction within the lumen.
Also described herein are systems including any of these rigidizing aspiration sheath catheters. Each of the components of these systems may be used separately or in combination. These systems may include multiple versions of any of these components. For example a cardiovascular aspiration system (e.g., a system for aspiration of clot material) may include: any of the rigidizing aspiration sheath catheters described herein, any of the aspiration catheters described herein, and any of the suction lines (including all or some of the suction line components described herein).
As mentioned, the rigidizing aspiration sheath catheter may include: an elongate flexible body comprising a plurality of layers, including a rigidizing layer and compression layer that is configured to transition the rigidizing layer between a flexible state and a rigid state, and a lumen extending through the elongate flexible body, and a hemostasis valve region at a proximal end of the elongate flexible body, and comprising a housing having a central bore that is continuous with the lumen, and comprising a first annular seal within the central bore that is continuous with the lumen, and comprising an annular seal within the central bore and at least one actuator movable coupled to the housing and configured to open and close the annular seal or to seal around a device positioned within the central bore, wherein the at least one actuator is sized and shaped to be used by one hand of a user.
An aspiration catheter may be configured to be inserted through the central bore and into the lumen of the rigidizing aspiration sheath catheter, the aspiration catheter comprising a mating attachment connector at a proximal end. The aspiration catheter may be non-rigidizing. It may be of particularly high flexibility, in that it is engineered to operate within a rigidizing conduit. The region that extends beyond a rigidized catheter may therefore be particularly navigable, in a manner that would not be possible should be exist by itself and without the assistance of a dynamically rigidizing conduit. The aspiration catheter may be rigidizing (e.g., may include a plurality of layers, including a rigidizing layer and a compression (e.g., bladder) layer that is configured to transition the rigidizing layer between a flexible state and a rigid state). In some examples the aspiration catheter is steerable. For example, the aspiration catheter may include one or more actuating steering members. The actuating steering members may be any appropriate steering member, including mechanical steering members (e.g., one or more tendons, cables, wires, etc., actuators, etc.), pneumatic steering members, magnetic steering members, thermal steering members (e.g., using a shape memory alloy or shape memory polymers, etc.). Although the examples described herein include primarily actuating steering members comprising one or more cables, any appropriate actuating steering member may be used in any of these apparatuses and methods.
A vacuum line may include: a mating attachment at a distal end of vacuum line configured to lockingly engage with the mating attachment connector of the aspiration catheter. As mentioned, the mating attachment may be a universal attachment for coupling with one or more of the catheters of the system. For example, the mating attachment may include a bayonet-type attachment as well as one or more finger-grip regions enhancing the ease of use. The vacuum line may include vacuum tubing. Any of these apparatus may include a vacuum activation valve. This apparatus may be hand-triggered, comprising a handle and configured to open or close the vacuum line, wherein the hand-triggered vacuum activation valve is connected in-line with the mating attachment, wherein a proximal end of the vacuum line is further configured to couple to vacuum pump and blood collection chamber. This valve may be a roller mechanism that pinches the vacuum tubing locally.
In some examples the system includes a clot capture chamber that may be connected in-line with hand-triggered vacuum activation valve and may include a visualization chamber mounted above an exit port, wherein the exit port is connected to the proximal end region of the vacuum line. The clot capture chamber may include a removable tray within the visualization chamber. The removable tray may be sized to conform to an inner perimeter of the clot capture container. In some examples the clot capture chamber comprises a transparent lid, which may include one or more tabs. The tray may have a mesh size such that blood passes through, but clot does not. For example, the mesh may have a mesh size of between about 0.037 mm and about 6 mm (e.g., between about 0.05 mm and about 5 mm, between about 0.1 mm and about 4 mm, between about 0.2 mm and 3 mm, between about 0.3 mm and 2.5 mm, between about 0.5 mm and about 4 mm, between about 0.75 mm and about 4 mm, etc.).
As mentioned, any of these systems may include an aspiration catheter configured to be inserted through the central bore and into the lumen of the rigidizing aspiration sheath catheter, the aspiration catheter comprising a second mating attachment connector, wherein the mating attachment at the distal end of vacuum line is configured to lockingly engage with the second mating attachment connector or the first mating attachment connector. The aspiration catheter may comprise an aspiration lumen extending therethrough and an aspiration catheter hemostasis valve region at a proximal end.
For example, a system for clot aspiration may include a rigidizing aspiration sheath catheter comprising: an elongate flexible body comprising a plurality of layers, including a rigidizing layer and bladder layer configured to transition the rigidizing layer between a flexible state and a rigid state, and a lumen extending through the elongate flexible body; and a hemostasis valve region at a proximal end of the elongate flexible body, and comprising a housing having a central bore that is continuous with the lumen of the elongate flexible body, and comprising a first annular seal within the central bore that is configured to seal around a device positioned within the central bore, and at least one first actuator movable coupled to the housing and configured to open and close the annular seal, wherein the at least one or more actuators is sized and shaped to be used by one hand of a user, and a first mating attachment connector; an aspiration catheter configured to be inserted through the central bore and into the lumen of the rigidizing aspiration sheath catheter, the aspiration catheter comprising: an elongate aspiration body including an aspiration lumen extending therethrough; a hemostasis valve region at a proximal end of the aspiration catheter, the hemostasis valve region comprising a housing having an aspiration hemostasis valve central bore that is continuous with the aspiration lumen, and an annular seal within the aspiration hemostasis valve central bore configured to seal around a device positioned within the central bore, at least one second actuator movable coupled to the elongate aspiration body, and configured to open and close the annular seal, wherein the at least one second actuator is sized and shaped to be used by one hand of the user, and a second mating attachment connector; and a vacuum line comprising: a mating attachment at a distal end of vacuum line configured to lockingly engage with the first mating attachment connector or the second mating attachment connector; a hand-triggered vacuum activation valve comprising a handle and configured to open or close the vacuum line, wherein the hand-triggered vacuum activation valve is connected in-line with the mating attachment; a clot capture chamber connected in-line with hand-triggered vacuum activation valve, and comprising a visualization chamber mounted above an exit port, wherein the exit port is connected to the proximal end region of the vacuum line; and wherein a proximal end of the vacuum line is further configured to couple to vacuum pump and blood collection chamber.
In general, a method for removing clot material may include: advancing a rigidizing aspiration sheath catheter in a vessel while the rigidizing aspiration sheath catheter is in a flexible state so that a distal end of the rigidizing aspiration sheath catheter is near a clot material within a vessel, wherein the proximal end of the rigidizing aspiration sheath catheter comprises a hemostasis valve portion; transitioning the rigidizing aspiration sheath catheter from the flexible state to a more rigid state; and aspirating through the rigidizing aspiration sheath catheter in the more rigid state to remove the clot material.
For example, described herein are methods of using any of the apparatuses described herein. For example, described herein are methods of removing clot material that may include: advancing a rigidizing aspiration sheath catheter so that a distal end of the rigidizing aspiration sheath catheter is at or near a treatment location, wherein the proximal end of the rigidizing aspiration sheath catheter comprises a hemostasis valve portion; transitioning the rigidizing aspiration sheath catheter from a flexible state to a rigid state; inserting an aspiration catheter through a hemostasis valve portion of the rigidizing aspiration sheath catheter, wherein the aspiration catheter is coupled to a vacuum line; extending the aspiration catheter distally out of the rigidizing aspiration sheath catheter; and activating a handle of a hand-triggered activation valve that is in-line with the vacuum line to aspirate through the aspiration catheter.
Any of these methods may include observing a clot material aspirated through the aspiration catheter within a window of a clot capture chamber connected in-line with hand-triggered vacuum activation valve.
In general, these methods may include applying suction through the rigidizing aspiration sheath catheter instead of, or in addition to, applying suction through the aspiration catheter. For example, any of these methods may include coupling the vacuum line to the proximal end of the rigidizing aspiration sheath catheter and activating the handle of the hand-triggered activation valve that is in-line with the vacuum line to aspirate through the rigidizing aspiration sheath catheter.
As mentioned, these apparatuses may be used with or without a guidewire, either for the entire procedure or for the portion of the procedure following initially placing the rigidizing aspiration sheath catheter (e.g., rigidizing overtube). For examples, advancing the rigidizing aspiration sheath catheter may include advancing the rigidizing aspiration sheath catheter without the use of a guidewire. In some examples advancing the rigidizing aspiration sheath catheter comprises advancing the aspiration catheter distally relative to the rigidizing aspiration sheath catheter in the rigid state and steering a distal end of the aspiration catheter. The method may further include advancing the rigidizing aspiration sheath catheter in the flexible state over the aspiration catheter and rigidizing the rigidizing aspiration sheath catheter. In some examples advancing the rigidizing aspiration sheath catheter comprises advancing the aspiration sheath catheter with an obturator within a lumen of the rigidizing aspiration sheath catheter.
Any of these apparatuses and methods may include hemostasis valves built into the rigidizing aspiration sheath catheter. For example, a method may include actuating an actuator of the hemostasis valve portion to allow insertion of the aspiration catheter through its central bore.
For example, described herein are rigidizing aspiration sheath catheter apparatus that include a rigidizing elongate body (e.g., a pressure-rigidizing elongate body) that is integrated with a hemostasis valve at the proximal end. As mentioned, an apparatus may include: an elongate body comprising lumen extending therethrough, the elongate body further comprising a rigidizing layer and a bladder layer that are configured to transition the elongate body between a flexible state and a rigid state by the application of pressure; and a hemostasis valve region extending proximally from the elongate flexible body, the hemostasis valve region comprising a housing having a central bore that is continuous with the lumen, an annular seal within the central bore, and at least one actuator movably coupled to the housing and configured to open and close the annular seal or to seal around a device positioned within the central bore.
Any of these apparatuses may be systems that also include one or more aspiration catheters. The aspiration catheter may also include an integrated hemostasis region (e.g., at a proximal end). The proximal ends of the rigidizing aspiration sheath catheters and the aspiration catheters may be adapted to interchangeably engage with a suction (aspiration) line. Any of the rigidizing aspiration sheath catheters may be steerable or may be steered by using an obturator and/or guidewire. In some cases the rigidizing aspiration sheath catheter include one or more distal steering regions that may be steered from the proximal end, e.g., by pulling on a tendon. In some cases the obturator configured to fit into the rigidizing aspiration sheath catheter may be steerable. In some cases the obturator adapted to fit snugly into the rigidizing aspiration sheath catheter may adapt the rigidizing aspiration sheath catheter for use with a guidewire (e.g., the obturator may include a guidewire lumen).
The methods described herein may be methods for treatment of any cardiovascular disorder, including, but not limited to removing clot material from an artery or a vein, including but not limited to the neurovasculature, the coronary vasculature, the peripheral vasculature, or the pulmonary vasculature, including the pulmonary artery. For example, advancing the rigidizing aspiration sheath catheter to the treatment location may include advancing a distal end of the rigidizing catheter to a pulmonary artery of a patient.
Although in general, these methods and apparatuses describe the use of a rigidizing aspiration sheath catheter (rigidizing overtube) and one or more non-rigidizing aspiration catheters that may extend from the rigidizing aspiration sheath catheter, any of these methods and apparatuses may include a rigidizing (e.g., pressure rigidizing) aspiration catheter. Thus, in some cases both the rigidizing aspiration sheath catheter and the aspiration catheter may be rigidizing by the application of pressure (positive and/or negative pressure).
In general, these methods and apparatuses may hold the rigidizing overtube in a rigid state while applying suction (aspiration) through one or both of the rigidizing overtube and/or an aspiration catheter. This may be particularly, and surprisingly, advantageous, as it may prevent movement of the rigidizing aspiration sheath catheter (e.g., rigidizing overtube) within the lumen of the vessel, even when the distal tip of the rigidizing aspiration sheath catheter is near the vessel wall, and even at relatively high suction (e.g., flow rate). This may prevent latching of the rigidizing aspiration sheath catheter to the wall. Rigidizing the rigidizing aspiration sheath catheter may also prevent inadvertent movement of the aspiration catheter that may otherwise occur within the vessel when aspiration is applied.
All of the methods and apparatuses described herein, in any combination, are herein contemplated and can be used to achieve the benefits as described herein.
A better understanding of the features and advantages of the methods and apparatuses described herein will be obtained by reference to the following detailed description that sets forth illustrative embodiments, and the accompanying drawings of which:
Described herein are methods and apparatuses (e.g., devices, systems, etc.) for cardiovascular treatment. These methods and apparatuses may be configured for removal of clot material (e.g., for clot capture) by aspiration, and may include one or more rigidizing (e.g., dynamically rigidizing) catheters that can provide a platform for the aspiration system. Using a rigidizing system to navigate to locations within the vasculature, for example deep within the vasculature, can advantageously allow for creation of a stable pathway to the treatment site through which aspiration can be performed. Using a stable pathway can advantageously allow for enhanced kinematics of catheter based instruments used during interventional procedures. For example, in some embodiments, the system allows for 1:1 control of catheter-based instruments. Additionally, a stable pathway reduces the need for repeated navigation to the treatment site and repeated use of contrast during visualization of the navigation. These advantages of using a rigidizing system platform simplify procedures, greatly improve outcomes, and increase patient safety.
In general, these method and apparatuses may include a rigidizing (e.g., dynamically rigidizing) aspiration sheath catheter that may include an elongate flexible body having a plurality of layers, including one or more rigidizing layer and a compression layer (e.g., a bladder layer) configured to transition the rigidizing layer between a flexible state and a rigid state. The rigidizing aspiration sheath catheter may include a lumen extending through the elongate flexible body and an integrated hemostasis valve. The integrated hemostasis valve may be part of a hemostasis valve region at a proximal end of the elongate flexible body.
The dynamically rigidizing catheters described herein may be controllable switched between a highly flexible state and one or more (or a continuously increasing) stiff or rigid state(s). In some examples the rigidizing catheter may be configured so that the flexible states is the resting state (e.g., without a pressure differential being applied). In general, the flexible state may be a low resting energy state. That is, in its flexible state the catheter may exert very low forces on the anatomy. In its rigid state(s) the catheter may exert low forces on the anatomy, and when the catheter is released (either intentionally or accidentally) it may still have a low potential energy. Thus, the catheter may avoid or prevent movement recoil (e.g., “kick”, which may occur when transitioning to applying suction), and may stay in the same position. This may be particularly beneficial as compared to non-rigidizing devices that may have higher energy states (sometimes much higher), and that apply a recoil force that can injure the patient when released (either intentionally or accidentally).
These method and apparatuses may also include an aspiration catheter that may be inserted into the rigidizing aspiration sheath catheter, which may also include a hemostasis valve region. The aspiration catheter may be steerable (e.g., may include an actuating steering member). In some examples the aspiration catheter may be rigidizing as well.
In some examples the method and apparatuses described herein may include a vacuum line with one or more of: a hand-triggered vacuum activation valve and/or a clot capture chamber for visualizing and removing clot material aspirated by the system.
The rigidizing aspiration sheath catheter may be used with one or more obturators 132. In
The apparatus 1010 (e.g., system) in
Other system components may include tubing (suction line) connecting the rigidizing aspiration sheath catheter and/or aspiration catheter to a source of aspiration 124. The rigidizing aspiration sheath catheter and/or aspiration catheter may be connected view a sealing connection to the suction line, which may be connected in-line to a clot collection chamber 120, and/or a suction (e.g., vacuum) activation valve, which may be activated to apply the suction to the rigidizing aspiration sheath catheter and/or aspiration catheter. The apparatus may also include a blood collection chamber 122 before the source of aspiration 123 (e.g., suction pump). These components may be arranged between the rigidizing aspiration sheath catheter and/or aspiration catheter and the source of aspiration in any appropriate order.
For example,
The hemostatic seal region in this example includes a pair of actuators 1042 (shown as levers). Depressing levers 1042 can allow for release of a device (e.g., aspiration catheter) positioned within the rigidizing catheter 1030. When the levers are in their unbiased state, extending outwardly from the body of the seal 1032, the seal valve is closed (shown in
In
In some embodiments, the rigidizing aspiration sheath catheter inner lumen comprises a hydrophilic coating. This coating can help facilitate insertion of an obturator and other devices and accessories.
In some embodiments, an outer surface of the rigidizing aspiration sheath catheter comprises a hydrophobic coating. This type of coating can help facilitate smooth motion through an introducer sheath.
The rigidizing aspiration sheath catheter may have an inner lumen diameter of the lumen of about 0.03-0.6 in. In some embodiments, the rigidizing aspiration sheath catheter inner lumen diameter is about 0.16 in. This inner diameter allows compatibility with a 12F catheter. In some embodiments, the inner lumen diameter is about 0.2-0.3 in. This inner diameter allows compatibility with a 20F catheter. In some embodiments, the rigidizing catheter inner lumen is about 0.34 in. This inner diameter allows compatibility with a 26F catheter.
In some embodiments, the rigidizing catheter outer diameter is about 0.2-0.4 in. In some embodiments, the outer diameter is about 0.23 in. or about 18F. In some embodiments, the outer diameter is about 0.34 in. or about 26F. In some embodiments, the rigidizing catheter as a length of about 70-120 cm (or about 80-115 cm, or about 85-115 cm, etc.). In some embodiments, the rigidizing catheter has a minimum bend radius of about 1-2 in. (or about 1.5 in.).
The system can include an obturator 1084 which can be used during navigation of the rigidizing aspiration sheath catheter 1030. Examples of obturators are described in International Application No. PCT/US2023/062206, filed Feb. 6, 2023, the entirety of which is incorporated by reference herein. The obturator 1084 can comprise a connector 1062 at its proximal end. The obturator 1084 may be configured to be inserted into the rigidizing aspiration sheath catheter 1030 through the hemostatic seal. Once the obturator 1084 is completely inserted within the rigidizing aspiration sheath catheter 1030, the obturator can be rotated to lock it in place with respect to the hemostatic seal. The rotation of connector 1062 relative to a threaded connection 1064 on the hemostatic seal region may create a lock between the mating mechanism 1064 and corresponding mating mechanism 1066 (e.g., thread, bayonet connection, etc.) on the obturator connector 1062. In some embodiments, the connector and obturator are rotated about 90° relative to one another. Other amounts of relative rotation (e.g., about 30-360° are also contemplated).
As described in further details below, the rigidizing aspiration sheath catheter can be transitioned between a flexible and a rigid state upon application of pressure. In the flexible state, the rigidizing aspiration sheath catheter can be navigated (in some examples over a guidewire, though in some examples no guidewire is needed or used) through tortuous anatomy and vasculature. Once the rigidizing catheter has navigated to a desired location, transitioning the rigidizing aspiration sheath catheter to a rigid state preserves the shape of the catheter at the time of rigidization and provides a stable pathway for navigation of other accessories and tools through the catheter, again without requiring a guidewire (or without further use of a guidewire). The ability to transform the rigidizing aspiration sheath provides a number of advantages to the apparatuses described herein that are not realizable with existing apparatuses. In particular, in the flexible configuration the aspiration sheath may conform to the patient's anatomy, whereas a standard catheter is more rigid and therefore exerts a force that forces the anatomy to adapt to it; once converted to a rigid (or semi-rigid) state, the aspiration sheath may prevent or minimize force on the same anatomy, and my support operations from the aspiration sheath.
In some embodiments, the rigidizing aspiration sheath catheter can be configured to be at maximum rigidization about application of 6 atm of positive pressure. In some applications, maximum rigidization can occur with the application of 10, 20, 30, 40, or 50 atm. In some embodiments, the rigidizing catheter can be configured to be flexible upon application of negative pressure. In some embodiments, the rigidizing catheter (rigidizing aspiration sheath catheter) can be configured to be flexible without the application of pressure. Other configurations are also contemplated, as described in further detail below.
Any dynamically rigidizing structure may be used as part of the rigidizing aspiration sheath catheter described herein, or optionally the aspiration catheters. For example, variations of rigidizing aspiration sheath catheters (“rigidizing catheters”) that can be used with the aspiration system described herein can be long, thin, and hollow and can transition quickly from a flexible configuration (i.e., one that is relaxed, limp, or floppy) to a rigid configuration (i.e., one that is stiff and/or holds the shape it is in when it is rigidized). In some examples the rigidizing apparatus may include a plurality of layers (e.g., coiled or reinforced layers, slip layers, rigidizing layers, bladder layers, sealing sheaths, etc.) that can together form the wall of the rigidizing devices, which may be referred to as “layered rigidizing apparatuses.” Unless the context makes clear otherwise, the methods and apparatuses described herein may refer to any appropriate rigidizing device, including layered rigidizing apparatuses. For example, the rigidizing devices (members, apparatuses, etc.) described herein may be rigidized by jamming particles, by phase change, by interlocking components (e.g., cables with discs or cones, etc.) or any other rigidizing mechanism. The rigidizing devices can transition from the flexible configuration to the rigid configuration, for example, by applying a vacuum or pressure to the wall of the rigidizing device or within the wall of the rigidizing device. With the vacuum or pressure removed, the layers can easily shear or move relative to each other, including the rigidizing layer(s). With the vacuum or pressure applied, the layers can transition to a condition in which they exhibit substantially enhanced ability to resist shear, movement, bending, torque and buckling, thereby providing system rigidization. Examples of rigidizing layers that may be rigidized by the application of pressure (positive or negative pressure), may include layers formed of one or more filaments that cross over each other, e.g., in a braid, weave, knit, etc. The rigidizing layer may be organized (e.g., knit, braid, weave, etc.) or may be disorganized (e.g., a mixture of filament fragments of uniform or varying lengths), or some combination of these. The crossing filaments of the rigidizing layer may be adjacent to the bladder layer, which may be driven against the rigidizing layer to rigidize the device. The examples of rigidizing apparatuses described herein may use pressure (positive pressure) and/or negative pressure to selectively and controllably rigidize the apparatus. In general, the method described herein may be used with any appropriate rigidizing apparatus.
The rigidizing (e.g., selectively rigidizing) apparatuses described herein can provide rigidization for a variety of medical applications, including catheters, sheaths, scopes (e.g., endoscopes), wires, overtubes, trocars or laparoscopic instruments. The rigidizing devices can function as a separate add-on device or can be integrated into the body of catheters, sheaths, scopes, wires, or laparoscopic instruments. The devices described herein can also provide rigidization for non-medical structures.
An exemplary rigidizing apparatus is shown in
Exemplary rigidizing devices in a rigidized configuration are shown in
The rigidizing apparatuses (e.g., rigidizing aspiration sheath catheter, and in some case aspiration catheters) described herein can toggle between a rigid configuration and a flexible configuration quickly, and in some examples with an indefinite number of transition cycles. In some examples the degree of rigidization (e.g., the stiffness) of the apparatus may also be adjusted, for example, by adjusting the positive pressure (in examples that are rigidized by positive pressure) or vacuum (in examples rigidized by vacuum). As interventional medical devices are made longer and inserted deeper into the human body, and as they are expected to do more exacting therapeutic procedures, there is an increased need for precision and control. Selectively rigidizing devices (including selectively rigidizing overtubes) as described herein can advantageously provide both the benefits of flexibility (when needed) and the benefits of stiffness (when needed). Further, the rigidizing devices described herein can be used, for example, with classic endoscopes, colonoscopes, robotic systems, and/or navigation systems, such as those described in International Patent Application No. PCT/US2016/050290, filed Sep. 2, 2016, titled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE,” the entirety of which is incorporated by referenced herein.
The rigidizing aspiration sheath catheters described herein can additionally or alternatively include any of the features described with respect to International Patent Application No. PCT/US2016/050290, filed on Sep. 2, 2016, titled “DEVICE FOR ENDOSCOPIC ADVANCEMENT THROUGH THE SMALL INTESTINE,” published as WO 2017/041052, International Patent Application No. PCT/US2018/042946, filed on Jul. 19, 2018, titled “DYNAMICALLY RIGIDIZING OVERTUBE,” published as WO 2019/018682, International Patent Application No. PCT/US2019/042650, filed on Jul. 19, 2019, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” published as WO 2020/018934, and International Patent Application No. PCT/US2020/013937 filed on Jan. 16, 2020, titled “DYNAMICALLY RIGIDIZING COMPOSITE MEDICAL STRUCTURES,” the entireties of which are incorporated by reference herein.
The rigidizing devices described herein can be provided in multiple configurations, including different lengths and diameters. In some examples, the rigidizing devices can include working channels (for instance, for allowing the passage of typical endoscopic tools within the body of the rigidizing device), balloons, nested elements, and/or side-loading features.
For example, a rigidizing apparatus 100 (also referred to as an apparatus, e.g., system and/or device, including a rigidizable member) may be configured to be rigidized by the application of vacuum, e.g., negative pressure. These apparatuses may generally be formed of layers that are configured to form a laminates structure when negative pressure is applied, so that one or more braided or woven layers may be reversibly fused to a flexible outer layer that is driven against a more rigid inner layer.
The innermost layer 115 can be configured to provide an inner surface against which the remaining layers can be consolidated, for example, when a vacuum is applied within the walls of the rigidizing device 100. The structure can be configured to minimize bend force and/or maximize flexibility in the non-vacuum condition. In some examples, the innermost layer 115 can include a reinforcement element 150z or coil within a matrix, as described above. In the example shown in
The layer 109 can be a first rigidizing layer including braided strands 133 similar to as described elsewhere herein. The rigidizing layer can be, for example, 0.001″ to 0.040″ thick. For example, a rigidizing layer can be 0.001″, 0.003″, 0.005″, 0.010″, 0.015″, 0.020″, 0.025″ or 0.030″ thick. In some examples, as shown in
The layer 107 can be another radial gap layer similar to layer 111.
In some examples, the rigidizing devices described herein can have more than one rigidizing layer. For example, the rigidizing devices can include two, three, or four rigidizing layers. Referring to
The layer 103 can be another radial gap layer similar to layer 111. The gap layer 103 can have a thickness of 0.0002-0.04″, such as approximately 0.03″. A thickness within this range can ensure that the strands 133 of the rigidizing layer(s) can easily slip and/or bulge relative to one another to ensure flexibility during bending of the rigidizing device 100.
The outermost layer 101 can be configured to move radially inward when a vacuum is applied to pull down against the rigidizing layers 105, 109 and conform onto the surface(s) thereof. The outermost layer 101 can be soft and atraumatic and can be sealed at both ends to create a vacuum-tight chamber with layer 115. The outermost layer 101 can be plastic, a plastomer, or elastomeric, e.g., made of urethane. The hardness of the outermost layer 101 can be, for example, 30 A to 80 A. Further, the outermost layer 101 can have a thickness of 0.0001-0.01″, such as approximately 0.001″, 0.002, 0.003″ or 0.004″. Alternatively, the outermost layer can be plastic, including, for example, LDPE, nylon, or PEEK.
In some examples, the outermost layer 101 can, for example, have tensile or hoop fibers 137 extending therethrough. The hoop fibers 137 can be made, for example, of aramids (e.g., Technora, nylon, Kevlar), Vectran, Dyneema, carbon fiber, fiber glass, boron, basalt, polyester, or other plastic. Further, the hoop fibers 137 can be positioned at 2-50, e.g., 20-40 hoops per inch. In some examples, the hoop fibers 137 can be laminated within an elastomeric sheath. The hoop fibers can advantageously deliver higher stiffness in one direction compared to another (e.g., can be very stiff in the hoop direction, but very compliant in the direction of the longitudinal axis of the rigidizing device). Additionally, the hoop fibers can advantageously provide low hoop stiffness until the fibers are placed under a tensile load, at which point the hoop fibers can suddenly exhibit high hoop stiffness.
In some examples, the outermost layer 101 can include a lubrication, coating and/or powder (e.g., talcum powder) on the outer surface thereof to improve sliding of the rigidizing device through the anatomy. The coating can be hydrophilic (e.g., a Hydromer® coating or a Surmodics® coating) or hydrophobic (e.g., a fluoropolymer). The coating can be applied, for example, by dipping, painting, or spraying the coating thereon.
The innermost layer 115 can similarly include a lubrication, coating (e.g., hydrophilic or hydrophobic coating), and/or powder (e.g., talcum powder) on the inner surface thereof configured to allow the bordering layers to more easily shear relative to each other, particularly when no vacuum is applied to the rigidizing device 100, to maximize flexibility.
In some examples, the outermost layer 101 can be loose over the radially inward layers. For instance, the inside diameter of layer 101 (assuming it constitutes a tube) may have a diametrical gap of 0″-0.200″ with the next layer radially inwards (e.g., with a rigidizing layer). This may give the vacuum rigidized system more flexibility when not under vacuum while still preserving a high rigidization multiple. In other examples, the outermost layer 101 may be stretched some over the next layer radially inwards (e.g., the rigidizing layer). For instance, the zero-strain diameter of a tube constituting layer 101 may be from 0-0.200″ smaller in diameter than the next layer radially inwards and then stretched thereover. When not under vacuum, this system may have less flexibility than one wherein the outer layer 101 is looser. However, it may also have a smoother outer appearance and be less likely to tear during use.
In some examples, the outermost layer 101 can be loose over the radially inward layers. A small positive pressure may be applied underneath the layer 101 in order to gently expand layer 101 and allow the rigidizing device to bend more freely in the flexible configuration. In this example, the outermost layer 101 can be elastomeric and can maintain a compressive force over the braid, thereby imparting stiffness. Once positive pressure is supplied (enough to nominally expand the sheath off of the braid, for example, 2 psi), the outermost layer 101 is no longer is a contributor to stiffness, which can enhance baseline flexibility. Once rigidization is desired, positive pressure can be replaced by negative pressure (vacuum) to deliver stiffness.
A vacuum can be carried within rigidizing device 100 from minimal to full atmospheric vacuum (e.g., approximately 14.7 psi). In some examples, there can be a bleed valve, regulator, or pump control such that vacuum is bled down to any intermediate level to provide a variable stiffness capability. The vacuum pressure can advantageously be used to rigidize the rigidizing device structure by compressing the layer(s) of braided sleeve against neighboring layers. Braid is naturally flexible in bending (i.e., when bent normal to its longitudinal axis), and the lattice structure formed by the interlaced strands distort as the sleeve is bent in order for the braid to conform to the bent shape while resting on the inner layers. This results in lattice geometries where the corner angles of each lattice element change as the braided sleeve bends. When compressed between conformal materials, such as the layers described herein, the lattice elements become locked at their current angles and have enhanced capability to resist deformation upon application of vacuum, thereby rigidizing the entire structure in bending when vacuum is applied. Further, in some examples, the hoop fibers through or over the braid can carry tensile loads that help to prevent local buckling of the braid at high applied bending load.
The stiffness of the rigidizing device 100 can increase from 2-fold to over 50-fold, for instance 10-fold, 15-fold, or 20-fold, when transitioned from the flexible configuration to the rigid configuration. In one specific example, the stiffness of a rigidizing device similar to rigidizing device 100 was tested. The wall thickness of the test rigidizing device was 1.0 mm, the outer diameter was 17 mm, and a force was applied at the end of a 9.5 cm long cantilevered portion of the rigidizing device until the rigidizing device deflected 10 degrees. The forced required to do so when in flexible mode was only 30 grams while the forced required to do so in rigid (vacuum) mode was 350 grams.
In some examples of a vacuum rigidizing device 100, there can be only one rigidizing layer. In other examples of a vacuum rigidizing device 100, there can be two, three, or more rigidizing layers. In some examples, one or more of the radial gap layers or slip layers of rigidizing device 100 can be removed. In some examples, some or all of the slip layers of the rigidizing device 100 can be removed.
The rigidizing layers described herein can act as a variable stiffness layer. The variable stiffness layer can include one or more variable stiffness elements or structures that, when activated (e.g., when vacuum is applied), the bending stiffness and/or shear resistance is increased, resulting in higher rigidity. In some of the apparatuses described herein, the variable stiffness layer comprises one or more filaments forming a plurality of filament regions that cross over each other and are free to move (e.g., slide) relative to one another in the flexible configuration, but may be increasingly constrained in the rigidizing state(s) when applying pressure (positive and/or negative pressure), which in some examples may drive a bladder layer against and/or into the variable stiffness layer. Other variable stiffness elements can be used in addition to or in place of the rigidizing layer. In some examples, engagers can be used as a variable stiffness element, as described in International Patent Application No. PCT/US2018/042946, filed Jul. 19, 2018, titled “DYNAMICALLY RIGIDIZING OVERTUBE,” the entirety of which is incorporated by reference herein. Alternatively or additionally, the variable stiffness element can include particles or granules, jamming layers, scales, rigidizing axial members, rigidizers, longitudinal members or substantially longitudinal members.
The rigidizable apparatuses described herein may also be rigidized by the application of positive pressure, rather than vacuum. For example, referring to
For example,
The pressure gap 2112 can be a sealed chamber that provides a gap for the application of pressure to layers of rigidizing device 2100. The pressure can be supplied to the pressure gap 2112 using a fluid or gas inflation/pressure media. The inflation/pressure media can be water or saline or, for example, a lubricating fluid such as oil or glycerin. The lubricating fluid can, for example, help the layers of the rigidizing device 2100 flow over one another in the flexible configuration. The inflation/pressure media can be supplied to the gap 2112 during rigidization of the rigidizing device 2100 and can be partially or fully evacuated therefrom to transform the rigidizing device 2100 back to the flexible configuration. In some examples, the pressure gap 2112 of the rigidizing device 2100 can be connected to a pre-filled pressure source, such as a pre-filled syringe or a pre-filled insufflator, thereby reducing the physician's required set-up time.
The bladder layer 2121 can be made, for example, of a low durometer elastomer (e.g., of shore 20 A to 70 A) or a thin plastic sheet. The bladder layer 2121 can be formed out of a thin sheet of plastic or rubber that has been sealed lengthwise to form a tube. The lengthwise seal can be, for instance, a butt or lap joint. For instance, a lap joint can be formed in a lengthwise fashion in a sheet of rubber by melting the rubber at the lap joint or by using an adhesive. In some examples, the bladder layer 2121 can be 0.0002-0.020″ thick, such as approximately 0.005″ thick. The bladder layer 2121 can be soft, high-friction, stretchy, and/or able to wrinkle easily. In some examples, the bladder layer 2121 is a polyolefin or a PET. The bladder 2121 can be formed, for example, by using methods used to form heat shrink tubing, such as extrusion of a base material and then wall thinning with heat, pressure and/or radiation. When pressure is supplied through the pressure gap 2112, the bladder layer 2121 can expand through the gap layer 2111 to push the rigidizing layer 2109 against the outermost containment layer 2101 such that the relative motion of the braid strands is reduced.
The outermost containment layer 2101 can be a tube, such as an extruded tube. Alternatively, the outermost containment layer 2101 can be a tube in which a reinforcing member (for example, metal wire, including round or rectangular cross-sections) is encapsulated within an elastomeric matrix, similar to as described with respect to the innermost layer for other examples described herein. In some examples, the outermost containment layer 2101 can include a helical spring (e.g., made of circular or flat wire), and/or a tubular braid (such as one made from round or flat metal wire) and a thin elastomeric sheet that is not bonded to the other elements in the layer. The outermost containment layer 2101 can be a tubular structure with a continuous and smooth surface. This can facilitate an outer member that slides against it in close proximity and with locally high contact loads (e.g., a nested configuration as described further herein). Further, the outer layer 2101 can be configured to support compressive loads, such as pinching. Additionally, the outer layer 2101 (e.g., with a reinforcement element therein) can be configured to prevent the rigidizing device 2100 from changing diameter even when pressure is applied.
Because both the outer layer 2101 and the inner layer 2115 include reinforcement elements therein, the rigidizing layer 2109 can be reasonably constrained from both shrinking diameter (under tensile loads) and growing in diameter (under compression loads).
By using pressure rather than vacuum to transition from the flexible state to the rigid state, the rigidity of the rigidizing device 2100 can be increased. For example, in some examples, the pressure supplied to the pressure gap 2112 can be between 1 and 40 atmospheres, such as between 2 and 40 atmospheres, such as between 4 and 20 atmospheres, such as between 5 and 10 atmospheres. In some examples, the pressure supplied is approximately 2 atm, approximately 4 atmospheres, approximately 5 atmospheres, approximately 10 atmospheres, approximately 20 atmospheres. In some examples, the rigidizing device 2100 can exhibit change in relative bending stiffness (as measured in a simple cantilevered configuration) from the flexible configuration to the rigid configuration of 2-100 times, such as 10-80 times, such as 20-50 times. For example, the rigidizing device 2100 can have a change in relative bending stiffness from the flexible configuration to the rigid configuration of approximately 10, 15, 20, or 25, 30, 40, 50, or over 100 times.
Any of the rigidizing devices described herein can have a distal end section or sections with a different design that the main elongate body of the rigidizing device. As shown in
Referring to
Referring now to
The device may also include a port for coupling to a positive or negative pressure (e.g., tube 1038 in
In general, any of the apparatuses described herein may include a flush port. The flush port may be particularly advantageous, as it may allow for flushing of the catheter, and may also be used to inject contrast and for continuous hemodynamic measurements.
In
The amount of sealing achieved by the hemostasis valve 1170 can advantageously be dynamically adjusted during use (e.g., during a procedure with an aspiration catheter) by adjusting the position of the levers 1142, 1142′. For example, the user may feel the tactile feedback when operating the actuator, indicating the compression level of the soft annular elastomeric seal, and may adjust the seal, e.g., to reduce or increase drag on a medical device within the hemostatic valve as desired.
Devices to be inserted within the valve central bore 1172 and rigidizing catheter can comprise a proximal connector with a mating mechanism configured to attach to a corresponding mating mechanism 1164 at the proximal end of the valve 1132 to stabilize the device relative to the valve. In some embodiments, the mating mechanism comprises a bayonet feature. Other mating mechanisms (e.g., threaded connection) are also contemplated.
The amount of sealing achieved by the hemostasis valve region can advantageously be adjusted during use (e.g., during a procedure with an aspiration catheter) by adjusting the position of the levers 1242, 1242′. For example, the user may feel the tactile feedback when operating the actuator, indicating the compression level of the soft annular elastomeric seal, and may adjust the seal, e.g., to reduce or increase drag on a medical device within the hemostatic valve as desired.
The vacuum line connector 1206 can comprise a mating mechanism configured to attach to a corresponding mating mechanism 1264 at the proximal end of the valve to stabilize the device relative to the valve. In some embodiments, the mating mechanism comprises a bayonet feature. Other mating mechanisms (e.g., threaded connection) are also contemplated.
Also described herein are hand-triggered vacuum activation valves.
The hand-triggered valve 1300 includes a lower portion 1310 through which the vacuum line 1316 extends. A groove or channel 1308 configured to receive that vacuum line is shown in the section view of
Positioned above the lower portion is a handle 1302 comprising a loop extending distally from a proximal portion of the handle. The loop can be sized to be able to be gripped within the palm of a user. The lever 1304 extends proximally from a proximal portion of the hand-operated valve 1300. The lever 1304 is sized such that it can be actuated by one or more fingers of a user while the handle 1302 is being gripped within the palm of the user. A distance between the handle 1302 and the 1304 is selected to enable the lever 1304 to be actuated when the user is gripping the handle 1302. In some embodiments, the distance is about 0.3-1.5 inches. The loop (as shown in the side view) may comprise a number of shapes (polygonal, rectangular, ovular, etc.).
In
In some cases it may be helpful to store a vacuum activation valve 1300 with the control (e.g., lever 1304) in a closed/actuated position. This may prevent deformation of the valve (e.g., clamp, crip, etc.) mechanism and/or the channel 1316. For example,
The valve can have any appropriate length. In some examples the valve has a length of about 4-6 in (or about 3-5, 5-7, 5-6 in., etc.). The handle may be any appropriate length. For example, the length of the handle can be about 3-5 in. (or about 2-4 in., 4-6 in. 4-5 in., etc.). The length of the lever can be, e.g., about 3-5 in. (or about 2-4 in., 4-6 in. 4-5 in., etc.). The lever can be curved as shown in
Also described herein are clot capture chambers.
When under negative pressure from an attached vacuum source, the lid may be sealed to the container. To enable removal of the lid, a user may perform a vent to atmosphere to release the negative of pressure within the container. In some embodiments, this venting is controlled by a button 1408 positioned on the container.
The container 1402 can have a generally rectangular prism shape. Other shapes are also possible (e.g., square prism, elliptic cylinder, etc.). In some embodiments, the container 1404 comprises a length of about 3-5 in. (or about 2.5-5.5 in., 3.5-4.5 in., about 4 in., etc.). The container can have a width of about 1-3 in. (or about 0.75-3.25 in., 1.5-2.5 in., about 2 in., etc.). The container can have a depth of about 0.3-1.1 in. (or about-. 4-1.0 in., 0.5-0.9 in., 0.6-0.7 in., etc.).
Positioned within the container is a tray 1410.
The tray 1410 includes one or more intermediate surface(s) 1411 having apertures 1414 to allow for draining of blood and other fluids. In some embodiments, the intermediate surface comprises a screen or mesh like configuration. The apertures may be any sized to permit fluid (e.g., blood) to flow through, but retain clot material. The apertures (e.g., mesh) may be any appropriate size. For example, the apertures may be between about 0.037 mm and about 6 mm (e.g., between about 0.05 mm and about 5 mm, between about 0.1 mm and about 4 mm, between about 0.2 mm and 3 mm, between about 0.3 mm and 2.5 mm, between about 0.5 mm and about 4 mm, between about 0.75 mm and about 4 mm, etc.). In some examples the intermediate surface may include multiple layers of mesh having different mesh sizes in order to progressively filter out smaller and smaller clot sizes without clogging the chamber. The different layers may be separated by a gap (e.g., of between about 0.5 mm to 2 cm). These mesh regions may be removable to allow analysis and/or capture of the different size clots and/or cleaning (including sterilization).
The tray 1410 may include channels 1416 along two opposing sides to allow access to a vacuum lumen. The channels 1416 may be U-shaped. This shape may allow the channels to partially surround a vacuum aperture on a side of the container.
The tray can have a length of about 3-5 in. (or about 2.5-5.5 in., 3.5-4.5 in., about 4 in., etc.). The tray can have a width of about 1-3 in. (or about 0.75-3.25 in., 1.5-2.5 in., about 2 in., etc.). The tray can have a depth of about 0.3-1.1 in. (or about-. 4-1.0 in., 0.5-0.9 in., 0.6-0.7 in., etc.).
In some embodiments, the tray comprises a polymer, such as acrylonitrile butadiene styrene (ABS).
An exemplary method of using the aspiration system described herein comprises navigating through the vasculature to or near a desired clot treatment site using a guidewire (e.g., 0.014″ or a 0.035″ wire). A rigidizing catheter can then be advanced, in a flexible state, over the guidewire to or near the clot treatment site. Once at or near the site, the rigidizing catheter may be transitioned to the rigid state. An obturator can be used during advancement of the rigidizing catheter. At this point, the guidewire may be removed, if so desired. Removing the guidewire can advantageously free up space within the lumen of the rigidizing catheter.
Once the rigidizing catheter is in the rigid space, it creates a stable conduit or platform from which treatment can be initiated. An aspiration catheter can be advanced through the rigidizing catheter. The aspiration catheter can have a proximal connector configured to lock to the hemostasis valve of the rigidizing catheter. The aspiration catheter can have a bigger inner lumen than traditional aspiration catheters because the stable platform created by the rigidizing catheter reduces the need for the aspiration catheter to perform accurate navigation and allows it to have a larger central bore. As mentioned here, the rigidizing catheters described herein may provide sufficient support (e.g., mechanical integrity) to one or more additional devices or components to allow these additional components (guidewires, aspiration catheter, stent, heart valve, tools, etc.) to be more flexible than other components. The stiffness necessary for the control and operation of a standalone component may become redundant when used within the rigidizing catheters described herein, which may provide the mechanical support that is otherwise required in the standalone component.
In some embodiments, the aspiration catheter can be switched out for a different aspiration catheter (e.g., comprising a different size). The hemostasis valve can be actuated to release the first aspiration catheter and insert the second aspiration, allowing for a quick exchange of the aspiration catheters. The aspiration catheter handle can be actuated to release the first aspiration catheter from the vacuum line and a second aspiration catheter can be connected to the vacuum line.
In some embodiments, the aspiration catheter may be removed to allow for flushing of the aspiration line. The rigidization catheter maintaining the stable pathway to the treatment site allows for this flushing to occur without losing the catheter position.
In some embodiments, the method further comprises visualizing aspirated material through the transparent lid of the clot capture container. In some embodiments, the container may be vented, and the lid removed. The tray may be replaced with another clean tray, for example, if the container is getting full. Traditional aspiration systems do not allow for a large enough aspiration lumen size to aspirate enough material to require this replaceable tray feature. A single tray can be used throughout the procedure, or multiple trays can be used—for example, one tray for each suction attempt or for each clot removed.
In some embodiments, aspiration can be performed directly through the rigidizing catheter.
In general, the removal of clot material may result in the loss of large blood volumes. Blood loss can be associated with the duration of the aspiration and the proximity of the aspiration catheter tip to the clot. However, the methods and apparatuses described herein may be configured to minimize blood loss. For example, the use of rigidizing apparatuses as described herein may allow apparatuses to be positioned proximate to the clot, which may minimize the blood volume required to move the clot. The stabilization achieved with the rigidizing catheters described herein may improve access to the clot and leads to better engagement between the tip of the aspiration catheter and the clot, resulting in lower blood loss by virtue of early and improved clot engagement. In addition, the methods and apparatuses described herein may be used without the use of guidewires. In particular, the apparatuses described herein may be configured to accommodate a cardiotomy reservoir (e.g., a suction canister/blood filter), which may be integrated within a thrombectomy circuit as described herein.
The suction cannister may filter and/or treat the blood so that it may be reintroduced into the body. For example the suction canister 1222 may include filtration to remove clot material and/or may be treated with one or more agents to reduce or prevent infection and/or to reduce and prevent clotting (e.g., anticoagulants). As mentioned above, the optional clot capture 1220 device may also filter clot material before it reaches the suction canister 1222. In general the filtered and/or treated blood may be reintroduced back into the body either directly or indirectly, e.g., by first passing to a blood bag 1226. Supplemental blood may be provided.
In general, the sterility of the operating sterile field may be maintained by keeping all of these elements (e.g., the blood bag, suction cannister, clot capture device, handle, etc.) within the sterile field. Any or all of these components may be single-use and/or reusable (and sterilizable).
The rigidizing aspiration catheter may be inserted into an access site 1205 on the patient's body, such as the femoral artery. Note that any appropriate access region may be used (e.g., radial, ulnar, axillary, brachial, dorsalis pedis, posterior tibial). In
For example,
In some examples, after aspirating one or more times, by activating and releasing the extraction handle 1218, a state of vacuum may be re-established between extraction handle and the blood capture chamber 1222 (e.g., reservoir), including the portion of the blood return line up to the patient; a check valve may be included on the blood return line. Blood may be held by the blood capture region. In any of these examples, an optional blood return circuit may be included, as shown. In this example, the blood return circuit includes a return tubing line 1344.
In any of these methods, the rigidizing aspiration sheath catheter may be used to support a second catheter, an aspiration catheter, which may be inserted through the rigidizing aspiration sheath catheter, as described above. The rigidizing aspiration sheath catheter may be uncoupled from the suction line, the aspiration catheter inserted through the rigidizing aspiration sheath catheter (e.g., using the posterior hemostasis valve of the rigidizing aspiration sheath catheter) and the aspiration catheter coupled to the suction line, all while the rigidizing aspiration sheath catheter remains in the rigid configuration. Suction may then be applied through the aspiration catheter, while the rigidizing aspiration sheath catheter remains rigid, to support the aspiration catheter.
When it is time to reinfuse blood to the patient the vacuum may be removed (e.g., bringing the system to atmospheric pressure) which may be done by pressing a release control (e.g., button) on the clot capture chamber 1220, which may leak air into the system in a controlled manner. Air and any remaining blood may be in the clot capture chamber 1220 may be driven to the blood capture chamber/filter 1222. In some cases the lid of the clot capture chamber may be taken off to maintain this state. At this point, a user could use a syringe at the check valve to pump/reinfuse blood to the patient, or a more automated blood return may be used.
As mentioned, in some examples the blood return circuit may be direct, and may couple from the suction canister/blood filter directly back into the patient's body, as shown in
As mentioned, the order of the components of the blood circuit may be different.
As mentioned above, the methods and apparatuses described herein may also improve the steering (e.g., guidance) and operation of suction catheters applied through the rigidizing aspiration sheath catheters described herein. For example, the use of dynamic rigidization by the rigidizing aspiration sheath catheter provide a sable pathway through the vasculature of the body, and may be used without a guidewire, or with a highly flexible guidewire, where other systems may require the use of guidewire and/or more rigid guidewires. This is because the rigidizing aspiration sheath catheter may be frozen and/or locked (or in some cases just partially stiffened) into a shape or pathway that remains relatively fixed. In the stiffer configuration the apparatus may provide a reference platform against which the catheter inserted through the rigidizing aspiration sheath catheter (e.g., an aspiration catheter) may be driven. For example, when steering an aspiration catheter, one or more pull wires may be used to change the orientation of the catheter, including to angulate a tip; for the angulation to occur at the distal end of the catheter, the proximal end of the catheter must remain relatively stiff enough to overcome total tension of pull wire. Thus, this may limit the overall flexibility of the catheters used. In contrast the rigidizing aspiration sheath catheters described herein may provide the necessary support, when rigidized, to allow for the sufficient mechanical advantage. Thus, a highly flexible aspiration catheter may be used with a rigidizing aspiration sheath catheter that may support the proximal end of the more flexible aspiration catheter.
A rigidizing aspiration sheath catheter may also act as a stable platform to allow mechanical support for other devices, such as (but not limited to) graspers, imaging system, probes, guidewires, or the like. The distal end of the rigidizing aspiration sheath catheter, when rigidized, may act as a control point for such instruments.
Any of the apparatuses described herein may be used in a fully rigidized or partially rigidized configuration. For example, the rigidity of the rigidizing aspiration sheath catheters described herein may be adjusted by increasing or decreasing the applied pressure. Typically the higher the pressure (higher positive pressure in some examples), the more rigid the rigidizing aspiration sheath catheter can become. This may allow the rigidizing aspiration sheath catheter to be partially stiffened. Further, the fac that the rigidizing aspiration sheath catheter may be restored to a highly flexible configuration may allow these devices to be inserted and removed without risking damaging the subject's anatomy. In practice, excessively stiff systems typically lead to vascular and hemodynamic complications, and frequently prevent reliable access to anatomies at the end of tortuous pathways. The rigidizing aspiration sheath catheters described herein may avoid such concerns by providing an anatomically conformable pathway that does not rely on anatomical support and/or accommodation while greatly extending the reach and stability to anatomies that have been difficult to access. This may allow users (e.g., doctors, technicians, etc.) to better plan their maneuvers, without having to anticipate where the anatomy will be based on catheter movement), and may provide an added level of safety by reducing the urgency that may result from the uncertainty caused by a moving target.
The rigidizing aspiration sheath catheters may also protect the adjacent anatomy. Once the rigidizing aspiration sheath catheter device is located and rigidized within the body, subsequent instruments introduced through the system are less likely to straighten the access pathway leading to unintended forces on the adjacent anatomy. In its flexible state, the rigidizing aspiration sheath catheter typically follows the patient anatomy. In its rigid state, the rigidizing aspiration sheath catheter reduces the tendency for inadvertent changes in the pathway. For example, a conventional introducing catheter has a defined flexibility. That sheath may be placed through the heart and the heart may accommodate it. However, when additional instruments are passed through the traditional sheath, the stiffness increases and acts to stiffen the overall system. The resulting straightening can deleteriously affect adjacent anatomical structures, potentially increasing tension on the right ventricle or exacerbating tricuspid valve regurgitation. In contrast, once the rigidizing aspiration sheath catheter is placed and rigidized within the anatomy, the ability of any additional instruments to straighten the access pathway is greatly reduced or eliminated. Consequently, the patient remains hemodynamically stable after insertion and rigidizing of the rigidizing aspiration sheath catheter, because there will not be further changes in the anatomical pathway while the rigidizing aspiration sheath catheter is stabilized, and the anatomy is isolated.
In addition, the rigidizing aspiration sheath catheters described herein may allow multiple exchanges with inserted tools without losing position. This allows flexibility and opportunity by freeing the procedure from the requirements for a guidewire, and allows the use of highly “soft” or flexible guidewires (e.g., guidewires having a stiffness of 10 GPa or less, e.g., 9.5 GPa or less, 9 GPa or less, 8.5 GPa or less, 8 GPa or less, 7.5 GPa or less, 7 GPa or less, 6.5 GPa or less, 6 GPa or less, 5.5 GPa or less, 5 GPa or less, 4.5 GPa or less, 4 GPa or less, 4 GPa or less, 3 GPa or less, 2 GPa or less, 1 GPa or less, etc., where stiffness corresponds to the flexural modulus in gigapascals, GPa) than about than may otherwise be possible with other catheters and catheter sheaths. This may improve the safety of the procedure by reducing the potential for perforation or laceration associated with stiff and extra stiff guidewires. Because the rigidizing aspiration sheath catheter maintains is position, a role normally relegated to the guidewire, guidewires can be easily exchanged and replaced without loss of position.
The rigidizing aspiration sheath catheters described herein may be dynamically rigidized to allow rapid positioning and repositioning. Thus, complex catheter procedures are possible, and the rigidizing aspiration sheath catheter may reduce or eliminate ancillary motion due to a stack-up of various flexible systems by stabilizing the entire system in the rigid configuration. This may result in reduced overhead and may simplify endovascular procedures.
In general, the rigidizing aspiration sheath catheters described herein may be transitioned from a highly flexible configuration to a more rigid configuration. In the rigid state, the rigidizing aspiration sheath catheter may have a higher stiffness than other aspiration catheters, which may allow for significantly more robust operation, providing a functional advantage of the system over other devices. Localized flexural stiffness measurements on traditional aspiration catheters (e.g., stiffness at localized points along the length of the catheter) as compared to the rigidizing aspiration sheath catheter in a rigid configuration have shown that the EI (e.g., Young's modulus x bending moment of inertia), or measurement in units of lbf-inch2 show a significant difference. For example, table 1, below shows measured EI values of a 20 F aspiration catheter and a 26F rigidizing aspiration sheath catheter, compared with a commercially available suction catheter (“traditional” catheter, shown as an INARI™ 20 F catheter). The units in table 1 are stiffness EI (lbf-inch2):
The EI stiffness is the stiffness (ratio of bending moment to curvature change) one would get for a homogenous material shaft (like a wire) with a Young's modulus of E and a cross-section corresponding to I. The rigidizing aspiration sheath catheter tested are heterogenous in structure, but it is still valid to characterize them with an equivalent EI parameter.
Recall the rigidizing aspiration sheath catheter may be first delivered up the vessel in its flexible state over its own obturator. Its composite EI stiffness (2.7 lbf-in2) is well below that of the proximal portion of the commercial catheter when it is delivered with its obturator (EI stiffness is 6.81 lbf-in2) and slightly higher that the stiffness of the distal portion of the commercial catheter (EI stiffness is 2.17 lbf-in2). Note the distal portion of the rigidizing aspiration sheath catheter is not necessarily intended to reach the target anatomy, so that slight increase of stiffness (2.7 lbf-in2 vs 2.17 lbf-in2) isn't really a disadvantage. Once the rigidizing aspiration sheath catheter reaches its target location and accommodates to the anatomical curvature, it is rigidized and the obturator is removed after which the EI stiffness becomes 55.6 lbf-in2, which is significantly higher than the stiffness of the commercial catheter with its obturator removed. Even though it is 12.7 times stiffer than the commercial catheter (proximal region), it is applying only minimal or negligible compressive tractions to its surroundings in contrast to the commercial catheter which has stored elastic energy needed to keep it in a curved shape and is compressively impinging on its surroundings.
An aspiration catheter may then be delivered up the rigidized rigidizing aspiration sheath catheter (on its own obturator, which may be removed after reaching target). The distal portion of the aspiration catheter may protrude beyond the distal end of the rigidizing aspiration sheath catheter and traverse the tortuous pulmonary artery anatomy.
The EI stiffness for the distal portion of the Aspiration catheter (0.92 lbf-in2) is significantly lower than the EI stiffness for the distal portion of the commercial catheter (1.67 lbf-in2). This means the aspiration catheter will have an advantage over commercial catheter when accessing tortuous anatomy.
In general, the catheters described herein (e.g., the rigidizing aspiration sheath catheter) may be any appropriate length, including up to more than 100 cm (e.g., 110 cm or longer, 115 cm or longer, 120 cm or longer, 125 cm or longer, 130 cm or longer, 135 cm or longer, etc.).
As mentioned above, the apparatuses described herein may be configured as part of a robotic system or for use with robotic apparatuses. In some examples the rigidizing aspiration sheath catheter system may include an outer tubular member that is robotically controlled, such as a robotically controlled overtube and/or endoscope assembly.
In the system 3100 in
In general, these methods and apparatuses may also be configured to prevent or eliminate hemolysis during the procedure. For example, any of these apparatuses and methods may infuse air into the clot capture container at a control rate (e.g., more slowly/gradually than simply releasing/opening the system). This can be done by modulating diameter of hole beneath the venting button.
In any of these apparatuses a venting button may be positioned on top of the reservoir (e.g. the blood capture/filter chamber 1222). The venting button could be similar to the one shown in
It should be appreciated that all combinations of the foregoing concepts and additional concepts discussed in greater detail below (provided such concepts are not mutually inconsistent) are contemplated as being part of the inventive subject matter disclosed herein and may be used to achieve the benefits described herein.
The process parameters and sequence of steps described and/or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and/or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed. The various example methods described and/or illustrated herein may also omit one or more of the steps described or illustrated herein or include additional steps in addition to those disclosed.
A person of ordinary skill in the art will recognize that any process or method disclosed herein can be modified in many ways. The process parameters and sequence of the steps described and/or illustrated herein are given by way of example only and can be varied as desired. For example, while the steps illustrated and/or described herein may be shown or discussed in a particular order, these steps do not necessarily need to be performed in the order illustrated or discussed.
The various exemplary methods described and/or illustrated herein may also omit one or more of the steps described or illustrated herein or comprise additional steps in addition to those disclosed. Further, a step of any method as disclosed herein can be combined with any one or more steps of any other method as disclosed herein.
When a feature or element is herein referred to as being “on” another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being “directly on” another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being “connected”, “attached” or “coupled” to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being “directly connected”, “directly attached” or “directly coupled” to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed “adjacent” another feature may have portions that overlap or underlie the adjacent feature.
Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items and may be abbreviated as “/”.
Spatially relative terms, such as “under”, “below”, “lower”, “over”, “upper” and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as “under” or “beneath” other elements or features would then be oriented “over” the other elements or features. Thus, the exemplary term “under” can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms “upwardly”, “downwardly”, “vertical”, “horizontal” and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.
Although the terms “first” and “second” may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.
Throughout this specification and the claims which follow, unless the context requires otherwise, the word “comprise”, and variations such as “comprises” and “comprising” means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term “comprising” will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.
In general, any of the apparatuses and methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as “consisting of” or alternatively “consisting essentially of” the various components, steps, sub-components or sub-steps.
As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word “about” or “approximately,” even if the term does not expressly appear. The phrase “about” or “approximately” may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/−0.1% of the stated value (or range of values), +/−1% of the stated value (or range of values), +/−2% of the stated value (or range of values), +/−5% of the stated value (or range of values), +/−10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value “10” is disclosed, then “about 10” is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that “less than or equal to” the value, “greater than or equal to the value” and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value “X” is disclosed the “less than or equal to X” as well as “greater than or equal to X” (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point “10” and a particular data point “15” are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.
Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others. Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.
The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the subject matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive subject matter may be referred to herein individually or collectively by the term “invention” merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.
This patent application claims priority to U.S. provisional patent application No. 63/505,062, titled “RIGIDIZING ASPIRATION SYSTEMS AND METHODS,” filed on May 30, 2023 and herein incorporated by reference in its entirety.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2024/031789 | 5/30/2024 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63505062 | May 2023 | US |
