Medical occluder delivery systems
A delivery system is provided for delivering and deploying an implantable balloon-based occlusion device including an inflatable balloon. The delivery system includes a handle including a plunger slidingly disposed in a fluid-retaining chamber, and a proximal rotatable user-control knob. A fluid-conveyance lumen catheter is shaped so as to define a catheter fluid-conveyance lumen in fluid communication with the fluid-retaining chamber and the inflatable balloon when the fluid-conveyance lumen catheter is coupled to the inflatable balloon. A catheter lumen shaft is configured to be in reversible connection with the balloon-based occlusion device, longitudinally slidable with respect to the handle. Rotation of the knob in a first rotational direction concurrently expels at least some of the fluid from the fluid-retaining chamber into the inflatable balloon, via the catheter fluid-conveyance lumen, and shortens a length of the balloon-based occlusion device by proximally pulling the catheter lumen shaft. Other embodiments are also described.
1 . A delivery system for delivering and deploying an implantable balloon-based occlusion device that includes an inflatable balloon, the delivery system comprising:
a delivery handle, which comprises:
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; and
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; and
a catheter lumen shaft, which is configured to be 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.
2 . The delivery system according to claim 1 , wherein 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.
3 . The delivery system according to claim 1 , wherein the catheter lumen shaft is disposed within the catheter fluid-conveyance lumen.
4 . The delivery system according to claim 1 , wherein the fluid-retaining chamber is disposed within the delivery handle.
5 . The delivery system according to claim 1 , wherein the delivery handle further comprises a distal user control, which is configured to release the balloon-based implant from the delivery system.
6 . The delivery system according to claim 1 , wherein the delivery handle comprises a window opening, and wherein 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.
7 . The delivery system according to claim 1 , wherein the delivery handle comprises 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.
8 . The delivery system according to claim 7 , wherein the delivery handle comprises 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.
9 . The delivery system according to claim 1 , further comprising a cannula extension, having one end thereof which is connected at one end of the cannula extension in fluid communication with the fluid-retaining chamber.
10 . The delivery system according to claim 1 , wherein the delivery handle further comprises a length-maintaining fluid user-control knob, and wherein 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.
11 . The delivery system according to claim 1 , wherein the delivery handle further comprises 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.
12 . The delivery system according to claim 11 ,
wherein the delivery handle further comprises an actuator, connected to the catheter lumen shaft, and
wherein 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.
13 . The delivery system according to claim 12 , wherein 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.
14 . The delivery system according to claim 11 ,
wherein the delivery handle further comprises a plunger pusher and an actuator connected to the catheter lumen shaft, and
wherein 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.
15 . The delivery system according to claim 11 ,
wherein the delivery handle comprises a safety latch, which is configured to assume locked and unlocked states,
wherein 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
wherein 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.
16 . An occlusion system comprising the delivery system according to claim 1 , the occlusion system further comprising the balloon-based occlusion device.
17 . The occlusion system according to claim 16 , wherein the balloon-based occlusion device comprises 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.
18 . The occlusion system according to claim 17 , wherein the balloon-based occlusion device further comprises 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.
19 . A method for delivering and deploying an implantable balloon-based occlusion device that includes an inflatable balloon, the method comprising, 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 a delivery handle; and
thereafter, rotating a proximal rotatable user-control knob of the 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.
20 . The method according to claim 19 , further comprising, 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.