Patent Application
20230146949
The present application relates generally to medical device systems and methods, that employ a catheter delivery systems or other device and liquid inflation lumens.
There are several types of pathologic passageways within the body. If located in blood vessels or in the heart, such passageways can cause alteration of blood flow. Paravalvular leak is a common complication of patients undergoing implantation of either surgical or transcatheter prostheses. The left atrial appendage (LAA) is a cavity that presents in the left atrium of the heart. In patients with atrial fibrillation the passage and steadiness of blood within this cavity can cause thrombus formation, which increase the risk of stroke. The option to treat these defects percutaneously may offers safer solution for high-risk patients, without exposing them to risk related to open heart reoperation. New concepts and implementations of occlusion devices based on detachable balloon implants are being developed, which are specifically designed for paravalvular leak occlusion, LAA occlusion or other irregular cardiovascular defects target sites.
The delivery of these new occlusion devices requires transcatheter methods and techniques using elongated catheter tools to target and position the devices at the desired implantation area in the subject's body.
The delivery of a balloon-based implant to a desired target site requires the performance of several steps, including navigation, trajectory, inflation, deflation, activation, dislocation, deployment and retrieval of the implant. Various systems have been developed for the delivery of balloon implants to a desired target site, which may be able to perform some or all of these required steps, usually by mean of handle controls, knobs or manipulation during the procedure by the operator. Some of these steps should be performed in combination among them, for a proper implant deployment, but the activation of them by the operator is sometimes not reliable, stable and efficient.
Some embodiments of the present invention provide a delivery system for controlling the inflation, deflation, activation and deployment of a detachable balloon-based implant in medical procedures involving blood vessels, body cavities, cardiovascular defects occlusion, treatment of left atrial appendage, and the like.
In some applications of the present invention, a delivery system is provided for the control and deployment of a cardiovascular device, for occluding a cardiovascular defect or a gap between a medical device and adjacent body tissue. The delivery system is for use with a guidewire and a balloon-based occlusion device. The delivery system enables over-the-wire engagement of the cardiovascular defect, the adjustment of the length and orientation of the occlusion devices during deployment, and the inflation of the balloon chamber with saline or another filling fluid. The delivery system automates the balloon-based implant inflation and its shortening to the deployment configuration
The delivery system comprises a fluid-retaining chamber, which is delimited by a tubular barrel having a proximal end, a distal end, and an internal surface. A plunger is slidingly disposed in the fluid-retaining chamber, as a movable membrane to draw fluid into the fluid-retaining chamber and expel fluid out of the fluid-retaining chamber, thereby filling and unfilling the fluid-retaining chamber, respectively. The fluid-retaining chamber includes a port at a distal end of the fluid-retaining chamber. The port is optionally connected to a cannular extension tube which is in fluid flow communication with the fluid-retaining chamber. The cannular extension may be used during or after the activation of the plunger into the fluid-retaining chamber to insert additional fluid into the fluid-retaining chamber and consequently into the balloon-based implant. The fluid-retaining chamber is configured to expel fluid to an catheter fluid-conveyance lumen connected proximally to the fluid-retaining chamber and distally coupled to the balloon-based implant. The expulsion of fluid from the fluid-retaining chamber inflates a balloon of the balloon-based implant during its deployment.
For some applications, the delivery system further comprises an actuator disposed longitudinally slidable in a delivery handle, in series to the fluid-retaining chamber, connected to a catheter lumen shaft which is in direct connection with the balloon-based implant throughout all the handle components and the catheter shaft which is connected to the implant. The actuator is longitudinally movable with respect to the delivery handle components so as to shorten or elongate a length of the implant.
For some applications, the delivery handle further comprises a double-threaded tube which connects and couples the actuation of the plunger into the fluid-retaining chamber and the longitudinal sliding of the actuator, automating the expulsion of fluid from the fluid-retaining chamber into the balloon-based implant, the withdrawing of fluid into the fluid-retaining chamber from the balloon-based implant, and the concurrent shortening or elongation, respectively, of the implant length. The double-threaded tube is activated by the rotation of a proximal rotatable user-control knob of the delivery handle.
In some applications of the present invention, the delivery handle further comprises a fluid-retaining chamber sliding mechanism which allows the movement of the fluid-retaining chamber over the plunger independently from the double-threaded tube. The fluid sliding chamber is actuated by a proximal rotatable user-control knob positioned the delivery handle.
In some applications of the present invention, the delivery handle further comprises a locking toggle mechanism which limits the movement of the double-threaded tube within a pre-fixed motion range. The locking toggle mechanism, when released, allows the prosecution of double-threaded tube movement until its full range of motion. The locking toggle mechanism is activated by a mechanical motion of a toggling button positioned on the delivery handle.
The delivery system thus provides for more reliable, stable, efficient, and simple delivery of inflatable balloon-based implants, automating some or all of the deployment steps performed manually in conventional deployment systems. The delivery system thus may reduce occurrence of misuse and other operator related implantation errors, and may reduce the overall procedure time required, and therefore reduce patient discomfort and improve precision and procedural outcomes. The delivery system may also reduce the amount of effort required by the physician prior to and during use of the system, as well as ensure that the balloon-based implant is properly implanted and maneuvered during insertion into the target tissue, during inflation of the balloon of the balloon-based implant, and during its deployment.
The device may further comprise a guidewire/infusion lumen disposed parallel to the catheter fluid-conveyance lumen, such as within catheter fluid-conveyance lumen. The guidewire/infusion lumen is also in fluid communication with the internal channel of the inflatable balloon, and may be used for wires, guidewires or fluid agent passage from the proximal end of the delivery handle, to the distal end of the balloon-based implant. The guidewire may be placed at the beginning of the delivery procedure, to guide the catheter to the target area. The agent delivered through this guidewire/infusion lumen may be used for fluoroscopic contrast fluid injection to the distal outlet of the balloon-based implant, outside of the balloon-based implant, as the balloon inflates. Such a configuration may be advantageous to evaluate the adherence of the balloon-based implant to the surrounding target anatomy, in order for the operator to evaluate if to further inflate the balloon-based implant in order to achieve complete adherence to the anatomy. A syringe may be used for the agent insertion into this guidewire/infusion lumen.
The delivery system may further comprise a micro-pump in fluid communication with the extension cannula to provide controlled balloon inflation without shortening of the implant. Alternatively, the micro-pump may be in communication with the fluid-retaining chamber, in order to activate the sliding movement of the chamber plunger and the activation of the coupled thread mechanism; such a configuration may be desirable to provide consistency in dose rates, amounts, and pressures, as well in device shortening, with limited operator interaction.
In another application of the present invention, a method is provided for inflating a balloon-based implant using blood from the patient during an implantation procedure, which is collected distally within the catheter and proximally to the implant.
The catheter system is provided with a delivery catheter connected to the balloon-based implant. The delivery catheter is shaped so as to define a fluid-retaining chamber within its lumen. A fluid passage hole is configured within this fluid-retaining chamber, passing through the shaft and in direct communication with the blood stream. A plunger is disposed within this fluid-retaining chamber, able to slide longitudinally using a delivery handle. Retracting the plunger proximally draws blood into this fluid-retaining chamber. Once the fluid-retaining chamber is full with the patient blood, the fluid-retaining chamber is circumferentially rotated to align its fluid passage hole to the connecting entrance of the fluid inflation catheter within the shaft, which is connected to the balloon-based implant. Once the fluid communication between the fluid-retaining chamber and the inflation catheter is completed, the plunger may be distally moved to provide inflation to the balloon-based implant.
These steps are reversible and may be used for deflating the balloon-based implant. These steps may be performed also more than once in series, to provide more inflation volume to the balloon-based implant.
This other application of the present invention may be combined with the other applications of the present invention described above.
There is therefore provided, in accordance with an application of the present invention, a delivery system for delivering and deploying an implantable balloon-based occlusion device that includes an inflatable balloon, the delivery system including:
a fluid-retaining chamber, delimited by a tubular barrel having a proximal end, a distal end, and an internal surface;
a plunger, which is slidingly disposed in the fluid-retaining chamber so as to provide a movable membrane configured to draw fluid into the fluid-retaining chamber and expel the fluid from the fluid-retaining chamber, thereby filling and unfilling the fluid-retaining chamber, respectively;
a delivery handle, which includes a proximal rotatable user-control knob;
a fluid-conveyance lumen catheter, which is shaped so as to define a catheter fluid-conveyance lumen in fluid communication (a) with the fluid-retaining chamber and (b) with the inflatable balloon of the balloon-based occlusion device when the fluid-conveyance lumen catheter is coupled to the inflatable balloon;
a catheter lumen shaft, which is in direct reversible connection with the balloon-based occlusion device, longitudinally slidable with respect to the delivery handle to set a shortening or elongation of a longitudinal dimension of the balloon-based occlusion device;
an actuator, connected to the catheter lumen shaft; and
a double-threaded tube, which is connected to the proximal rotatable user-control knob, and which connects and couples actuation of the plunger into the fluid-retaining chamber and longitudinal sliding of the actuator, such that rotation of the proximal rotatable user-control knob:
For some applications, the catheter lumen shaft is disposed within the catheter fluid-conveyance lumen of the fluid-conveyance lumen catheter.
For some applications, the fluid-retaining chamber is disposed within the delivery handle.
For some applications, the delivery handle includes a delivery-handle fluid-conveyance lumen tube, which is shaped so as to define a delivery-handle fluid-conveyance lumen in fluid communication with the fluid-retaining chamber and the catheter fluid-conveyance lumen.
For some applications, the delivery handle includes a delivery-handle lumen shaft, which is disposed within the delivery-handle fluid-conveyance lumen, and which extends from the catheter lumen shaft and longitudinally slidable with respect to the delivery handle.
For some applications, the delivery handle further includes a distal user control, which is configured to release the balloon-based implant from the delivery system.
For some applications, the delivery handle includes a window opening, and an external surface of the fluid-retaining chamber is marked with a scale that is visible through the window opening, to enable a user to monitor an amount of the fluid present within the fluid-retaining chamber.
For some applications, the apparatus further includes a cannula extension, which is connected at one end of the cannula extension in fluid communication with the fluid-retaining chamber.
For some applications, the delivery handle further includes a plunger pusher, and the double-threaded tube is shaped so as to define: a first thread that is threadedly coupled to a corresponding second thread defined by the plunger pusher, and a third thread that is threadedly coupled to a corresponding fourth thread defined by the actuator.
For some applications:
the delivery handle includes a safety latch, which is configured to assume locked and unlocked states,
the safety latch, when in the locked state, blocks the double-threaded tube from completion of concurrently (a) expelling at least some of the fluid from the fluid-retaining chamber into the inflatable balloon and (b) shortening the length of the balloon-based implant, and
the safety latch, when in the unlocked state, allows further rotation of the proximal rotatable user-control knob in the first rotation direction to complete concurrently (a) expelling at least some of the fluid from the fluid-retaining chamber into the inflatable balloon and (b) shortening the length of the balloon-based implant.
For some applications, the delivery handle further includes a length-maintaining fluid user-control knob, and the delivery handle is configured such that rotation of the length-maintaining fluid user-control knob, in a first rotational direction, proximally moves the fluid-retaining chamber within the delivery handle while the plunger remains longitudinally stationary, thereby expelling additional fluid from the fluid-retaining chamber into the balloon of the balloon-based implant without changing the length of the balloon-based occlusion device.
For some applications, the delivery system further includes a delivery catheter that includes the fluid-conveyance lumen catheter and the catheter lumen shaft, and the fluid-retaining chamber is disposed within the delivery catheter, in a proximal or distal position along the delivery catheter. For some applications, the fluid-retaining chamber is shaped so as to define two sub-chambers, having a shaft opening allowing the collection of blood from the patient circulatory system into the fluid-retaining chamber, and the injection of the collected blood into the balloon-based occlusion device.
For some applications, an occlusion system is provided that includes the delivery system and further includes the balloon-based occlusion device. For some applications, the balloon-based occlusion device includes an actuating shaft, which is (a) disposed at least partially within the balloon, (b) connected to a distal end portion of the balloon, and (c) longitudinally moveable with respect to a proximal end portion of the balloon so as to set a distance between the distal and the proximal end portions of the balloon. For some applications, the balloon-based occlusion device further includes a locking mechanism, which is configured to assume locked and unlocked states, and which is configured, when in the locked state, to maintain, between the distal end portion of the balloon and the proximal end portion of the balloon, the distance set using the actuating shaft.
There is further provided, in accordance with an application of the present invention, a delivery system for delivering and deploying an implantable balloon-based occlusion device that includes an inflatable balloon, the delivery system including:
a delivery handle, which includes:
a fluid-conveyance lumen catheter, which is shaped so as to define a catheter fluid-conveyance lumen in fluid communication (a) with the fluid-retaining chamber and (b) with the inflatable balloon of the balloon-based occlusion device when the fluid-conveyance lumen catheter is coupled to the inflatable balloon; and
a catheter lumen shaft, which is in reversible connection with the balloon-based occlusion device, longitudinally slidable with respect to the delivery handle,
wherein the delivery handle is configured such that rotation of the proximal rotatable user-control knob in a first rotational direction concurrently (a) expels at least some of the fluid from the fluid-retaining chamber into the inflatable balloon of the balloon-based occlusion device, via the catheter fluid-conveyance lumen, and (b) shortens a length of the balloon-based occlusion device by proximally pulling the catheter lumen shaft.
For some applications, the delivery handle is configured such that rotation of the proximal rotatable user-control knob in a second rotational direction opposite the first rotational direction concurrently (a) withdraws at least some of the fluid into the fluid-retaining chamber from the inflatable balloon of the balloon-based occlusion device, via the catheter fluid-conveyance lumen, and (b) elongates the length of the balloon-based occlusion device by distally pushing the catheter lumen shaft.
For some applications, the catheter lumen shaft is disposed within the catheter fluid-conveyance lumen.
For some applications, the fluid-retaining chamber is disposed within the delivery handle.
For some applications, the delivery handle further includes a distal user control, which is configured to release the balloon-based implant from the delivery system.
For some applications, the delivery handle includes a window opening, and an external surface of the fluid-retaining chamber is marked with a scale that is visible through the window opening, to enable a user to monitor an amount of the fluid present within the fluid-retaining chamber.
For some applications, the delivery handle includes a delivery-handle fluid-conveyance lumen tube, which is shaped so as to define a delivery-handle fluid-conveyance lumen in fluid communication with the fluid-retaining chamber and the catheter fluid-conveyance lumen.
For some applications, the delivery handle includes a delivery-handle lumen shaft, which is disposed within the delivery-handle fluid-conveyance lumen, and which extends from the catheter lumen shaft and longitudinally slidable with respect to the delivery handle.
For some applications, the apparatus further includes a cannula extension, which is connected at one end of the cannula extension in fluid communication with the fluid-retaining chamber.
For some applications, the delivery handle further includes a length-maintaining fluid user-control knob, and the delivery handle is configured such that rotation of the length-maintaining fluid user-control knob, in a first rotational direction, proximally moves the fluid-retaining chamber within the delivery handle while the plunger remains longitudinally stationary, thereby expelling additional fluid from the fluid-retaining chamber into the balloon of the balloon-based implant without changing the length of the balloon-based occlusion device.
For some applications, the delivery handle further includes a double-threaded tube, which is connected to the proximal rotatable user-control knob, and which connects and couples actuation of the plunger into the fluid-retaining chamber and longitudinal sliding of the catheter lumen shaft.
For some applications:
the delivery handle further includes an actuator, connected to the catheter lumen shaft, and
the delivery handle is configured such that rotation of the proximal rotatable user-control knob in the first rotational direction activates the double-threaded tube to concurrently (a) expel at least some of the fluid from the fluid-retaining chamber into the inflatable balloon of the balloon-based occlusion device, via the catheter fluid-conveyance lumen, and (b) shorten the length of the balloon-based occlusion device by proximally moving the actuator, which in turn proximally pulls the catheter lumen shaft
For some applications, the delivery handle is configured such that rotation of the proximal rotatable user-control knob in a second rotational direction opposite the first rotational direction, activates the double-threaded tube to concurrently (a) withdraw at least some of the fluid into the fluid-retaining chamber from the inflatable balloon of the balloon-based occlusion device, via the catheter fluid-conveyance lumen, and (b) elongate the length of the balloon-based occlusion device by distally moving the actuator, which in turn distally pushes the catheter lumen shaft.
For some applications, the delivery handle further includes a plunger pusher and an actuator connected to the catheter lumen shaft, and the double-threaded tube is shaped so as to define: a first thread that is threadedly coupled to a corresponding second thread defined by the plunger pusher, and a third thread that is threadedly coupled to a corresponding fourth thread defined by the actuator.
For some applications:
the delivery handle includes a safety latch, which is configured to assume locked and unlocked states,
the safety latch, when in the locked state, blocks the double-threaded tube from completion of concurrently (a) expelling at least some of the fluid from the fluid-retaining chamber into the inflatable balloon and (b) shortening the length of the balloon-based implant, and
the safety latch, when in the unlocked state, allows further rotation of the proximal rotatable user-control knob in the first rotation direction to complete concurrently (a) expelling at least some of the fluid from the fluid-retaining chamber into the inflatable balloon and (b) shortening the length of the balloon-based implant.
For some applications, an occlusion system is provided that includes the delivery system and further includes the balloon-based occlusion device. For some applications, the balloon-based occlusion device includes an actuating shaft, which is (a) disposed at least partially within the balloon, (b) connected to a distal end portion of the balloon, and (c) longitudinally moveable with respect to a proximal end portion of the balloon so as to set a distance between the distal and the proximal end portions of the balloon. For some applications, the balloon-based occlusion device further includes a locking mechanism, which is configured to assume locked and unlocked states, and which is configured, when in the locked state, to maintain, between the distal end portion of the balloon and the proximal end portion of the balloon, the distance set using the actuating shaft.
There is still further provided, in accordance with an application of the present invention, a method for delivering and deploying an implantable balloon-based occlusion device that includes an inflatable balloon, the method including, using a delivery system:
filling, with fluid, a fluid-retaining chamber of the delivery system, the fluid-retaining chamber delimited by a tubular barrel having a proximal end, a distal end, and an internal surface, wherein a plunger is slidingly disposed in the fluid-retaining chamber so as to provide a movable membrane;
using a delivery catheter of the delivery system, advancing the implantable balloon-based occlusion device to a desired site in a body of a subject, the delivery catheter including (i) a fluid-conveyance lumen catheter, which is shaped so as to define a catheter fluid-conveyance lumen in fluid communication (a) with the fluid-retaining chamber and (b) with the inflatable balloon of the balloon-based occlusion device when the fluid-conveyance lumen catheter is coupled to the inflatable balloon, and (ii) a catheter lumen shaft, which is in reversible connection with the balloon-based occlusion device, longitudinally slidable with respect to the delivery handle; and
thereafter, rotating a proximal rotatable user-control knob of a delivery handle of the delivery system in a first rotation direction, such that that the delivery system concurrently (a) expels at least some of the fluid from the fluid-retaining chamber into the inflatable balloon of the balloon-based occlusion device, via the catheter fluid-conveyance lumen, and (b) shortens a length of the balloon-based occlusion device by proximally pulling the catheter lumen shaft.
For some applications, the method further includes, after rotating the proximal rotatable user-control knob in the first rotation direction, rotating the proximal rotatable user-control knob in a second rotational direction opposite the first rotational direction, such that the delivery system concurrently (a) withdraws at least some of the fluid into the fluid-retaining chamber from the inflatable balloon of the balloon-based occlusion device, via the catheter fluid-conveyance lumen, and (b) elongates the length of the balloon-based occlusion device by distally pushing the catheter lumen shaft.
For some applications, rotating the proximal rotatable user-control knob in the first rotation direction rotates a double-threaded tube of the delivery handle.
For some applications:
the delivery handle includes a safety latch, which is configured to assume locked and unlocked states, and
rotating the proximal rotatable user-control knob in the first rotation direction includes, while the safety latch is in the locked state, rotating the proximal rotatable user-control knob in the first rotation direction until the safety latch blocks the delivery system from completion of concurrently (a) expelling at least some of the fluid from the fluid-retaining chamber into the inflatable balloon and (b) shortening the length of the balloon-based implant.
For some applications, the method further includes, after rotating the proximal rotatable user-control knob in the first rotation direction until the safety latch blocks the delivery system from the completion:
assessing whether the balloon-based occlusion device is properly deployed; and
upon assessing that balloon-based occlusion device is properly deployed, transitioning the safety latch to the unlocked state, and further rotating the proximal rotatable user-control knob in the first rotation direction to complete concurrently (a) expelling at least some of the fluid from the fluid-retaining chamber into the inflatable balloon and (b) shortening the length of the balloon-based implant.
For some applications, the method further includes, after rotating the proximal rotatable user-control knob in the first rotation direction until the safety latch blocks the delivery system from the completion:
assessing whether the balloon-based occlusion device is properly deployed; and
upon assessing that balloon-based occlusion device has a desired length and the balloon of the balloon-based occlusion device does not contain a desired amount fluid, adjusting an amount of the fluid in the balloon of the balloon-based occlusion device by rotating a length-maintaining fluid user-control knob of the delivery handle to move the fluid-retaining chamber within the delivery handle while the plunger remains longitudinally stationary, thereby adjusting the amount of the fluid in the balloon of the balloon-based implant without changing the length of the balloon-based occlusion device.
For some applications, the method further includes using a distal user control of the delivery handle to release the balloon-based implant from the delivery system.
For some applications, filling the fluid-retaining chamber includes filling the fluid-retaining chamber from a fluid source external to the delivery system, via a cannula extension, which is connected at one end of the cannula extension in fluid communication with the fluid-retaining chamber.
The present invention will be more fully understood from the following detailed description of embodiments thereof, taken together with the drawings, in which:
Reference is also made to
For some applications, balloon-based implant 20 is a balloon-based occlusion device. For example, the balloon-based occlusion device may comprise a proximal LAA-orifice cover 21 and inflatable balloon 22, surrounded by a conformable balloon frame 23. Optionally, the balloon-based occlusion device be configured as described hereinabove with reference to
Delivery system 10 comprises a delivery handle 11 and a delivery catheter 16. Delivery handle 11 comprises a proximal rotatable user-control knob 31 that is configured to activate a double-threaded tube 46 within handle 11, as described hereinbelow with reference to
Delivery handle 11 further comprises a fluid-retaining chamber 41, which is delimited by a tubular barrel 34 having a proximal end 36, a distal end 38, and an internal surface 40. Delivery handle 11 further comprises a plunger 30 that is slidingly disposed in fluid-retaining chamber 41 so as to define a distal movable membrane 45 (i.e., a distal surface of the head of plunger 30) to draw fluid into fluid-retaining chamber 41 and expel fluid out of fluid-retaining chamber 41, thereby filling and unfilling fluid-retaining chamber 41, respectively. For example, the fluid may comprise saline. Optionally the fluid may comprise a contrast agent.
Optionally, an external surface of fluid-retaining chamber 41 is marked with a scale that is visible through a window opening on delivery handle 11, to enable a user to monitor the amount of fluid present within fluid-retaining chamber 41 within delivery handle 11.
As shown in
It is noted that because catheter lumen shaft 26 is typically disposed within catheter fluid-conveyance lumen 19, only a portion of the volume of catheter fluid-conveyance lumen 19 is available for passage of the fluid, i.e., the space between an inner surface of fluid-conveyance lumen catheter 18 and an outer surface of catheter lumen shaft 26.
As shown in
It is noted that because delivery-handle lumen shaft 37 is typically disposed within delivery-handle fluid-conveyance lumen 28, only a portion of the volume of delivery-handle fluid-conveyance lumen 28 is available for passage of the fluid, i.e., the space between an inner surface of delivery-handle fluid-conveyance lumen tube 35 and an outer surface of delivery-handle lumen shaft 37.
Typically, a proximal end of delivery-handle fluid-conveyance lumen tube 35 is coupled to port 48.
Delivery system 10 further comprises a cannula extension 33, which is connected at one end of the cannula extension in fluid communication with fluid-retaining chamber 41. The other end of cannula extension 33 is configured to be coupled in fluid connection with a fluid source, such as one or more conventional syringes 50. To this end, cannula extension 33 typically comprises a connector 61, such as a valve 62 (e.g., a 3-way valve) or a stopcock, which optionally comprises a valve. Cannula extension 33 may be used to fill fluid-retaining chamber 41 at the beginning of the implantation procedure, such as by creating a vacuum within fluid-retaining chamber 41 using a first one of syringes 50, changing a position of 3-way valve 62, and then injecting fluid into fluid-retaining chamber 41 using a second one of syringes 50. Optionally, cannula extension 33 may be used during or after the distal advancement of plunger 30 into fluid-retaining chamber 41, in order to insert additional fluid into fluid-retaining chamber 41 and consequently into balloon 22 of balloon-based implant 20.
For some applications, catheter lumen shaft 26 is shaped so as to define a catheter guidewire lumen 27 (labeled in
For some applications, as show in
As shown in
Actuator 44 is disposed longitudinally slidable in delivery handle 11, coupled to delivery-handle lumen shaft 37, which, as mentioned above, extends from catheter lumen shaft 26. Actuator 44 is longitudinally movable with respect to delivery handle 11 so to shorten or elongate balloon-based implant 20.
Delivery handle 11 is configured such that the rotation of proximal rotatable user-control knob 31 actuates plunger pusher 42 and actuator 44 by rotating double-threaded tube 46, such that rotation of proximal rotatable user-control knob 31:
The result of the first transition described above (caused by rotation of proximal rotatable user-control knob 31 in the first rotational direction) is to cause the distal sliding of distal movable membrane 45 of plunger 30 within fluid-retaining chamber 41 and the fluid inflation of balloon 22 of balloon-based implant 20, concurrently with the shortening of balloon-based implant 20 (e.g., balloon frame 23 thereof), which is connected to actuator 44 via catheter lumen shaft 26 and delivery-handle lumen shaft 37, to bring balloon-based implant 20 to fully-inflated and shortened deployed configuration 25, as shown in
The second transition described above (caused by rotation of proximal rotatable user-control knob 31 in the second rotational direction) is the opposite, namely concurrent (a) refilling of fluid-retaining chamber 41 with fluid from balloon 22 and (b) lengthening of balloon-based implant 20. This may be desired in order to reposition or remove the implant before completion of the implantation procedure, and/or in order to adjust the implant size to better match a cardiovascular defect.
Delivery handle 11 is configured such that the rotation of proximal rotatable user-control knob 31 moves plunger 30 within fluid-retaining chamber 41 in a first longitudinal direction by a first distance, and moves catheter lumen shaft 26 in a second longitudinal direction, opposite the first longitudinal direction, by a second distance. For some applications, a ratio of the first and the second distances remains constant over all possible degrees of the rotation proximal rotatable user-control knob 31. As a result, a ratio of (a) the volume of fluid transferred out of or into fluid-retaining chamber 41 and (b) a change in the length of the balloon-based implant 20 remains constant over all possible degrees of the rotation proximal rotatable user-control knob 31. This is typically the case during rotation of the proximal rotatable user-control knob 31 in both the first and the second rotational directions.
In this phase, a contrast medium fluid may be injected (such as from a syringe) into lumen entrance 14, through delivery-handle guidewire lumen 29 and catheter guidewire lumen 27, to exit distally to balloon-based implant 20, to visually evaluate by x-ray imaging the adherence of the balloon-based implant to the surrounding target anatomy.
The distal end of catheter lumen shaft 26 is decoupled from balloon-based implant 20, such as by rotation of catheter lumen shaft 26, e.g., by rotation of proximal lumen entrance 14. For example, the decoupling techniques described hereinbelow with reference to
Reference is made to
For some applications, activation of distal user control 32 disconnects balloon-based implant 20 from delivery catheter 16 and thus from delivery system 10. For example, distal user control 32 may comprise a rotatable knob, rotation of which disconnects balloon-based implant 20 from delivery catheter 16, in which case distal user control 32 may have a threaded connection with a tube of delivery handle 11, such that the rotation proximally moves outer implant-coupling tube 68 with respect to delivery handle 11. Alternatively, distal user control 32 may be slidable with respect to delivery handle 11, such that sliding of the user control in a proximal direction proximally moves outer implant-coupling tube 68 with respect to delivery handle 11.
For some applications, fluid-retaining chamber 41 has a maximum volume of 50 ml, e.g., 20 ml.
For some applications, plunger 30 has a length of between 5 mm and 25 mm, typically 10 mm, and distal movable membrane 45 has a diameter of between 5 mm and 30 mm, typically 15 mm.
For some applications, double-threaded tube 46 has a length of between 20 mm and 150 mm, typically 100 mm, when in a closed configuration, and/or a length of between 40 mm and 200 mm, typically 150 mm, when in an open configuration.
For some applications, double-threaded tube 46 has a diameter of between 5 and 40 mm, typically 15 mm.
For some applications:
Reference is now made to
Reference is also made to
Delivery system 110 comprises a delivery handle 111 and delivery catheter 16. Delivery handle 111 comprises proximal rotatable user-control knob 31 that is configured to activate a double-threaded tube 146 within handle 111. Optionally, delivery handle 111 further comprises distal user control 32 that is configured to release balloon-based implant 20 from delivery catheter 16, such as described hereinabove for delivery system 10 with reference to
Delivery handle 111 further comprises a fluid-retaining chamber 141. Delivery handle 111 further comprises plunger 30 that is slidingly disposed in fluid-retaining chamber 141 so as to define distal movable membrane 45 (i.e., a distal surface of the head of plunger 30) to draw fluid into fluid-retaining chamber 141 and expel fluid out of fluid-retaining chamber 141, thereby filling and unfilling fluid-retaining chamber 141, respectively. As described below, plunger 30 and fluid-retaining chamber 141 may longitudinally move with each other either by longitudinal movement of plunger 30 or by longitudinal movement of fluid-retaining chamber 141. For example, the fluid may comprise saline. Optionally the fluid may comprise a contrast medium.
For some applications, as show in
For configurations in which first and third threads 164A and 166A are both internal threads (as shown) or are both external threads (configuration not shown), typically first and third threads 164A and 166A have opposite directions of threading (i.e., one is right-handed and the other left-handed). First and third threads 164A and 166A may have the same pitch as each other, or different pitches from one another.
Actuator 144 is disposed longitudinally slidable in delivery handle 111, coupled to delivery-handle lumen shaft 37, which, as mentioned above, extends from catheter lumen shaft 26. Actuator 144 is longitudinally movable with respect to delivery handle 111 so to shorten or elongate balloon-based implant 20.
The rotation of proximal rotatable user-control knob 31 actuates plunger pusher 142 and actuator 144 by rotating double-threaded tube 146, such that rotation of proximal rotatable user-control knob 31:
The result of the first transition described immediately above is to cause the distal sliding of distal movable membrane 45 of plunger 30 within fluid-retaining chamber 141 and the fluid inflation of balloon 22 of balloon-based implant 20, concurrently with the shortening of balloon-based implant 20 (e.g., balloon frame 23 thereof), which is connected to actuator 44 via catheter lumen shaft 26 and delivery-handle lumen shaft 37, to bring balloon-based implant 20 to fully-inflated and shortened deployed configuration 25, as shown in
For some applications, delivery system 110 is configured to additionally inflate balloon 22 of balloon-based implant 20 without additionally concurrently shortening balloon-based implant 20, such as shown in the transition between
For some of these applications, delivery handle 111 further comprises a length-maintaining fluid user-control knob 180. Delivery handle 111 is configured such that rotation of length-maintaining fluid user-control knob 180, in a first rotational direction, proximally moves fluid-retaining chamber 141 within delivery handle 111 while plunger 30 remains longitudinally stationary, as shown in the transition between
Typically, rotation of length-maintaining fluid user-control knob 180 in a second rotational direction, opposite the first rotation direction, has the opposite effect, namely drawing some of the fluid from balloon 22 back into fluid-retaining chamber 141, without changing a length of balloon-based implant 20.
For example, delivery handle 111 may comprise a length-maintaining fluid actuator 182, which is in threaded communication with length-maintaining fluid user-control knob 180. Rotation of length-maintaining fluid user-control knob 180 in the first rotational direction causes proximal movement of length-maintaining fluid actuator 182, which in turn causes the above-mentioned proximal movement of fluid-retaining chamber 141 within delivery handle 111 while plunger 30 remains longitudinally stationary, as shown in the transition between
For some applications, balloon-based implant 20 is configured such that once it has been shortened to a predetermined length, balloon-based implant 20 becomes irreversibly locked at the predetermined length and a fluid port of the balloon closes, preventing addition or removal of fluid, in order to maintain proper implantation of the implant in the surrounding anatomy, for example using locking mechanism 340, described hereinbelow with reference to
To this end, in some applications, delivery handle 11 comprises a safety latch 186, which is configured to assume a locked state, such as show in
For example, safety latch may limit distal motion of an element of delivery handle 11, such as plunger pusher 142, e.g., a radially-directed tab 192 thereof.
Once safety latch 186 has been transitioned to the unlocked state, such as shown in
In addition, if it is desired to introduce additional fluid into balloon 22, such as to achieve greater adherence of balloon-based implant 20 with the surround anatomy, additional fluid may be introduced from cannula extension 33 into delivery-handle fluid-conveyance lumen 28 (distal to fluid-retaining chamber 141) and to balloon 22 of balloon-based implant 20.
Reference is now made to
Delivery catheter 216 comprises a double fluid-retaining chamber 13 and an inflation catheter 52 which is directly connected to balloon-based implant 20. Double fluid-retaining chamber 13 is shaped so as to define an opening 51 on its surface, which places in contact the surrounding of delivery catheter 216 with one of two internal sub-chambers of double fluid-retaining chambers 13.
An opening 51 through the external surface of double fluid-retaining chamber 13 allows the fluid surrounding this opening to enter proximal chamber 55. During a cardiovascular procedure this fluid is blood 60. Opening 51 and double fluid-retaining chamber 13 may be placed equally proximally or distally along delivery catheter 216. Blood 50 can enter proximal chamber 55 only when opening 51 and groove 53 are aligned with each other. A plunger 56 is positioned within proximal chamber 55 and it is placed distally at the beginning of the procedure, at a longitudinal position X.
As shown in
As shown in
As shown in
These steps are reversible and may be used for deflating balloon-based implant 20. These steps may be performed also more than once in series, to provide more inflation volume to balloon-based implant 20.
Reference is also made to
For some applications, occlusion device 20 comprises:
Occlusion device 20 is configured such that proximally longitudinally moving actuating shaft 334 expands balloon 22 in a radial or a lateral direction by shortening the distance between distal and proximal end portions 336 and 338 of balloon 22 to a desired distance.
Locking mechanism 340 is configured, when in the locked state, to maintain, between distal end portion 336 of balloon 22 and proximal end portion 338 of balloon 22, the distance set using actuating shaft 334.
For some applications, occlusion device 20 is shaped so as to define a fluid flow path 344 along (e.g., alongside, as shown) a portion of actuating shaft 334. Valve 342 is configured to selectively:
For some applications, occlusion device 20 is configured such that reduction of the distance, by proximal longitudinal movement of actuating shaft 334:
For some applications, the first predetermined distance does not equal the second predetermined distance. For example, the first predetermined distance may be less than the second predetermined distance, such that the proximal longitudinal movement of actuating shaft 334 first automatically transitions valve 342 from the open state to the closed state and subsequently automatically transitions locking mechanism 340 from the unlocked state to the locked state. Alternatively, the first predetermined distance may be greater than the second predetermined distance, such that this sequence is reversed.
Further alternatively, for some applications, the first predetermined distance equals the second predetermined distance, such that the proximal longitudinal movement of actuating shaft 334 simultaneously automatically transitions valve 342 from the open state to the closed state and automatically transitions locking mechanism 340 from the unlocked state to the locked state.
As described hereinabove, in order to cause the above-mentioned proximal longitudinal movement of actuating shaft 334, the delivery system comprises a catheter lumen shaft 26, which is releasably coupled a proximal end portion of actuating shaft 334. For example, a distal portion of catheter lumen shaft 26 may comprise a pull-shaft coupling 348, which may, for example, be shaped so as to define a thread that removably engages a corresponding thread defined by the proximal end portion of actuating shaft 334. Rotation of catheter lumen shaft 26 disengages shaft coupling 348 from the corresponding thread defined by the proximal end portion of actuating shaft 334.
Occlusion device 20 is configured to be releasably connected to the delivery system. Occlusion device 20 is configured such that fluid flow path 344 is coupled in fluid communication with the delivery system when occlusion device 20 is releasably connected to the delivery system, such as shown in
For some applications, actuating shaft 334 is shaped so as to define, at least in part, a distal tip 350 disposed at distal end portion 336 of balloon 22, as shown in
For some other applications, occlusion device 20 further comprises a distal tip disposed at distal end portion 336 of balloon 22, and actuating shaft 334 is connected to the distal tip (configuration not shown).
Alternatively or additionally, for some applications, occlusion device 20 further comprises a proximal base disposed at proximal end portion 338 of balloon 22, and actuating shaft 334 is moveable (e.g., longitudinally or rotationally) with respect to the proximal base (configuration not shown).
For some applications, valve 342 is disposed along actuating shaft 334, such as shown in
For some applications, occlusion device 20 further comprises a proximal tube 352, which is axially fixed with respect to proximal end portion 338 of balloon 22. Actuating shaft 334 is slidably disposed partially within proximal tube 352, e.g., so as to indirectly connect actuating shaft 334 to proximal end portion 338 via proximal tube 352. For some of these applications, occlusion device 20 is shaped so as to define fluid flow path 344 along the portion of actuating shaft 334, radially between an external surface of actuating shaft 334 and an internal surface of proximal tube 352, such as shown in
For some applications, valve 342 comprises a seal 354 around at least a portion of (e.g., entirely around) the external surface of actuating shaft 334. Valve 342 is configured to assume (a) the open state when seal 354 is disposed at one or more first axial positions 356A with respect to proximal tube 352 (one such first axial position is shown in
For some applications, seal 354, actuating shaft 334, and proximal tube 352 are arranged such that seal 354 blocks fluid flow out of a distal end 358 of proximal tube 352, at least when seal 354 is disposed at the one or more first axial positions 356A with respect to proximal tube 352, such as shown in
For some applications, a wall of proximal tube 352 is shaped so as to define one or more tabs 360 through the wall. The one or more tabs 360 are biased to flex radially inward. When valve 342 is in the open state, as shown in
For some applications, the external surface of actuating shaft 334 is shaped so as to define one or more protrusions 366 around at least a portion of (e.g., entirely around) actuating shaft 334. Proximal ends 362 of the one or more tabs 360 are shaped so as to prevent distal movement of the one or more protrusions 366 when the one or more protrusions 366 are disposed proximal to the proximal ends 362 of the one or more tabs 360, such as shown in
For some applications, occlusion device 20 further comprises a proximal LAA-orifice cover 21, which:
This indirect connection of proximal LAA-orifice cover 21 to balloon 22 generally prevents an anodic reaction between the typically super-elastic (e.g., Nitinol) material of frame 372 of proximal LAA-orifice cover 21 and the typically plastically deformable (e.g., stainless steel) material of struts 380, described hereinbelow. Such a reaction might have occurred if the two elements were instead welded or otherwise bonded together in contact with each other. (Connection of the elements via an independent and passive element, such as an internal tube or shaft, also does not cause such a reaction.) Alternatively, proximal LAA-orifice cover 21 is directly connected to balloon 22, such as if frame 372 comprises a different plastically-deformable material, such as titanium.
For some applications, occlusion device 20 further comprises orifice-support stent 290, described hereinbelow with reference to
For some applications, actuating shaft 334 is shaped so as to define a guidewire lumen 376 for slidingly receiving therein a guidewire and/or passage of fluid injected under pressure, such as contrast media injected from the proximal handle of the delivery tool to the distal end of the occlusion device. Alternatively, for other applications, actuating shaft 334 is not shaped so as to define a guidewire lumen.
For some applications, compliant balloon 22 comprises a compliant material selected from the group consisting of: polycaprolactone (PCL), polyglycolic acid (PGA), polylactic acid (PLA), and polydioxanone (PDO or PDS), silicone, polyurethane, polytetrafluoroethylene (PTFE), polymethylmethacrylate, polyether ether ketone (PEEK), polyvinyl chloride, polyethylene terephthalate, nylon, polyamide, polyamide, and polyether block amide (PEBA).
For some applications, balloon 22 has an average wall thickness of between 100 and 5000 microns. Alternatively or additionally, for some applications, balloon 22 has, at a thinnest portion of a wall of balloon 22, a thinnest wall thickness of between 20 and 500 microns.
For some applications, occlusion device 20 further comprises connecting struts 380 fixed to distal end portion 336 of balloon 22 and to proximal end portion 338 of balloon 22. Struts 380 may be disposed inside balloon 22, outside balloon 22, or some inside and some outside balloon 22. For some applications, struts 380 are arranged as a frame. For some applications, struts 380 are arranged in a cage-like arrangement. Typically, struts 380 comprise a plastically-deformable material, such as stainless steel or titanium. Typically, struts 380 help shape balloon 22 as the balloon chamber is inflated and/or the balloon is shortened.
Typically, occlusion device 20 is configured such that inflation of balloon chamber 332 plastically deforms connecting struts 380. For some applications, occlusion device 20 is configured such that shortening of balloon 22 plastically deforms connecting struts 380.
For some applications, struts 380 are configured such that inflation of balloon chamber 332 primarily causes radial deformation of struts 380, rather than deformation of the struts in a distal or proximal direction. To this end, first lateral portions 381A of struts 380 arranged along a lateral surface of balloon 22 may be more compliant than second end portions 381B of struts 380 arranged on a distal surface of balloon 22 and/or on a proximal surface of balloon 22. For example, first lateral portions 381A may be thinner than second end portions 381B, as shown in
Reference is now made to
Reference is also made to
For some applications, occlusion device 20 comprises a proximal connector 384 that is configured to releasably connect occlusion device 20 to a correspondingly configured distal connector 86 of the delivery system, such as described hereinabove with reference to
For some applications, distal connector 86 comprises one or more legs that engage one or more respective coupling sites (e.g., slots) of proximal connector 384, such as perhaps best seen in
Alternatively, proximal connector 384 is shaped so as to define a thread (configuration not shown).
Typically, a healthcare worker places the distal end of occlusion device 20 into the LAA, using delivery system navigation.
As shown in
For some applications, struts 380 are shaped so as to define a plurality of spikes 389 that are initially generally axially oriented, as shown in
Reference is now made to
For some applications, proximal LAA-orifice cover 21 is asymmetric about proximal tube 352, e.g., elliptical or with a radius greater in one direction than in the perpendicular direction.
For some applications, proximal LAA-orifice cover 21 is configured to have an adjustable greatest dimension measured perpendicular to proximal tube 352. For example, rotation of a proximal LAA-orifice cover 21 adjustment mechanism may adjust the greatest dimension.
For some applications, covering 374 of proximal LAA-orifice cover 21 is blood-permeable, so as to serve as filter for the passage of blood in and out of the LAA. For other applications, covering 374 is not blood-permeable, so as to create a secondary sealing of the LAA in addition to the sealing provided by balloon 22.
For some applications, proximal LAA-orifice cover 21 is bioresorbable and/or drug-eluting.
For some applications, occlusion device 20 is implanted to treat paravalvular leak, for example as described in
In the context of the present disclosure, the terms “distal” and “proximal” are used accordingly to their standard meaning in the field of percutaneous cardiovascular devices. The term “proximal” refers to those components of the device assembly which, when following a delivery catheter during percutaneous delivery, are closer to the end of the catheter that is configured for manipulation by the user (e.g., a delivery handle manipulated by a physician). The term “distal” is used to refer to those components of the device assembly that are more distant from the end of the catheter that is configured for manipulation by the user and/or that are inserted farther into the body of a patient.
The term “compliant” used herein in relation with balloons or with structural components implies a deformability that substantially follows an applied force. Accordingly, a “compliant balloon” means a balloon which progressively expands under the effect of increasing radial pressure as long as a certain burst pressure is not exceeded.
As used herein, the term “strut” means an elongate structural element which can be formed, e.g., a thin wire, rod, or thick-walled tube, all of which do not necessarily have a circular cross section.
In an embodiment, the techniques and apparatus described herein are combined with techniques and apparatus described in one or more of the following patent applications, which are assigned to the assignee of the present application and are incorporated herein by reference:
It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description.
The present patent application claims priority from U.S. Provisional Application 62/994,465, filed Mar. 25, 2020, which is assigned to the assignee of the present application and incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/IB2021/052474 | 3/25/2021 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 62994465 | Mar 2020 | US |
