Stent's two-stage deployment handle
The two-stage deployment handle with a lever and carriage mechanism addresses the challenge of high static friction in stent deployment by using a rotational and sliding mechanism to overcome friction and ensure controlled expansion.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- INSPIRE M D LTD
- Filing Date
- 2021-12-07
- Publication Date
- 2026-06-08
AI Technical Summary
Deploying expandable medical devices, such as stents, is challenging due to high static friction between the sheath and the device, especially after prolonged compression, making controlled and stable retraction difficult.
A two-stage deployment handle with a lever and carriage mechanism that provides mechanical advantage to overcome friction, allowing controlled retraction in two steps: a rotational movement followed by a sliding motion to expose the device.
Facilitates stable and controlled expansion of medical devices by overcoming frictional forces, ensuring the device is not exposed until the second stage, providing precise deployment.
Smart Images
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Abstract
Description
Technical Field
[0001] The present invention relates to the deployment of stents and other expandable devices within a subject's body.
Background Art
[0002] U.S. Patent No. 9,867,701 (Patent Document 1) describes a delivery device for a foldable artificial heart valve, including an operating handle and a catheter assembly. The operating handle may include a housing that defines a movement space therein, a carriage assembly that is longitudinally movable within the movement space, a deployment actuator that is coupled to the housing and rotatable relative to the housing, and a coupling assembly that is rotationally fixed to the deployment actuator. The catheter assembly may include a first shaft around which a compartment is defined and a distal sheath that is operably connected to the carriage assembly. Longitudinal movement of the carriage assembly within the movement space can move the distal sheath between a closed state and an open state. The coupling assembly may have an engagement position where rotation of the deployment actuator moves the carriage assembly and a release position where rotation of the deployment actuator does not move the carriage assembly.
[0003] U.S. Patent No. 9,198,788 (Patent Document 2) describes a delivery system for delivering and deploying a prosthesis into a body lumen, and a method of using the same. The delivery system enables the delivery system to be operated with one hand while maintaining the accuracy of delivery and deployment of the prosthesis. An exemplary embodiment of the delivery system includes a first sheath control on the housing such that it is accessible from outside the housing, the first sheath control being operably engaged with the sheath and controlling the movement of the sheath axially proximally with respect to the housing, thereby releasing at least a portion of the prosthesis.
[0004] U.S. Patent No. 5,591,196 (Patent Document 3) describes a method for intraluminal delivery and deployment of an expandable prosthesis in a site within a body cavity. The method includes the steps of placing the prosthesis on a support having at least two movable wings attached to a catheter, moving the catheter through a passage in the body to deliver the prosthesis to a desired location, and moving the wings radially outward to thereby deploy the prosthesis within the passage in the body.
[0005] U.S. Patent No. 7,976,574 (Patent Document 4) describes a delivery system that utilizes a handle assembly including an actuation mechanism which can initially provide sufficient mechanical advantage to overcome static friction when initiating the deployment of a medical device. The actuation mechanism includes components that help increase the speed of deployment as the physician continues to operate the actuation mechanism.
[0006] U.S. Patent No. 10,327,927 (Patent Document 5) describes a blood tube intervention device delivery system including a catheter with its proximal end attached to a handle, and a distal carrier segment for attaching a blood tube intervention device thereon. The retractable sheath is movable from a first position covering the distal carrier segment to a second position retracted proximally and not covering the distal carrier segment. The pull is attached to the retractable sheath and extends proximally from the retractable sheath toward the handle. The majority of the pull's length has a cross-sectional shape with a concave surface facing the longitudinal axis and a convex surface facing away from the longitudinal axis. The cross-sectional shape is wider than it is thick.
[0007] U.S. Patent Application Publication 2009 / 0138023 (Patent Document 6) describes an actuator handle for use in an implantable medical device deployment system. The actuator handle includes a first actuator and a second actuator for operating and controlling first and second retaining members of the deployment system to achieve the release of a medical device from the deployment system. [Prior art documents] [Patent Documents]
[0008] [Patent Document 1] U.S. Patent No. 9,867,701 [Patent Document 2] U.S. Patent No. 9,198,788 [Patent Document 3] U.S. Patent No. 5,591,196 [Patent Document 4] U.S. Patent No. 7,976,574 [Patent Document 5] U.S. Patent No. 10,327,927 [Patent Document 6] U.S. Patent Application Publication 2009 / 0138023 [Overview of the Initiative]
[0009] According to some embodiments of the present invention, a device is provided for retracting a sheath from an expandable medical device. The device comprises: a shell configured to be coupled to a longitudinal element; a carriage disposed within the shell and configured to be coupled to a sheath; and a lever protruding from the shell, configured to retract the sheath by rotating proximal to move the carriage proximal by a first distance while the distal end of the longitudinal element is in contact with the expandable medical device, and then sliding proximal following the proximal rotation to move the carriage proximal by a second distance.
[0010] In some embodiments, the carriage is configured to be coupled to the sheath via one or more other longitudinal elements.
[0011] In some embodiments, the carriage is: A port configured to receive the distal end of a syringe; and Ports and tubular lumen for fluid communication; Shaped to define, and The carriage is configured to connect to the sheath by gripping the sheath or another longitudinal element connected to the sheath within the lumen, so that the fluid injected from the syringe flows through the lumen to the sheath.
[0012] In some embodiments, the shell is shaped to define a slit, and the lever is configured to rotate and slide proximal within the slit.
[0013] In some embodiments, the shell has a distal arched portion and a proximal straight portion, the lever is configured to rotate proximal while protruding from the distal arched portion, and the lever is configured to slide proximal while protruding from the proximal straight portion.
[0014] In some embodiments, the first distance is between 5 and 10 mm.
[0015] In some embodiments, the carriage is an inner carriage, the measure further has an outer carriage, and the lever is rotatably coupled to the outer carriage and configured to move the inner carriage proximal by a first distance relative to the outer carriage, and to move the inner carriage proximal by a second distance together with the outer carriage.
[0016] In some embodiments, a stopper is further provided within the shell, the shell being coupled to the longitudinal element by the stopper being coupled to the inside of the shell and to the proximal end of the longitudinal element, and the lever being configured to move the carriage proximal until the movement of the carriage is stopped by the stopper.
[0017] In some embodiments, the axial position of the stopper is adjustable.
[0018] In some embodiments, the base of the lever is shaped to define at least one outwardly projecting protrusion, and the inner wall of the shell is shaped to define at least one inwardly projecting protrusion that aligns with the outwardly projecting protrusion while the lever is rotating in the proximal direction. While the lever is rotating in the proximal direction, the inwardly projecting protrusion prevents the base of the lever from sliding in the proximal direction.
[0019] In some embodiments, the lever is shaped to define at least one protrusion, and the carriage is shaped to define at least one recess configured to receive the protrusion following rotation of the lever.
[0020] In some embodiments, the carriage is shaped to define a distal L-shaped protrusion, and the lever includes two legs spanning the distal L-shaped protrusion such that, prior to rotation of the lever, the vertical proximal-facing surface of the distal L-shaped protrusion contacts the lever.
[0021] According to some embodiments of the present invention, a method for retracting a sheath from over an expandable medical device is provided. The method has the step of rotating a lever projecting from a shell of a handle in a proximal direction such that the lever moves a carriage disposed within the shell and coupled to the sheath a first distance in the proximal direction. The method further has the step of, after rotating the lever, sliding the lever in the proximal direction such that the lever moves the carriage a second distance in the proximal direction.
[0022] In some embodiments, the carriage is shaped to define a port and a lumen in fluid communication with the port, and the carriage is configured to couple to the sheath by gripping the sheath, or another longitudinal element coupled to the sheath, within the lumen, and The method has, prior to the step of rotating the lever, inserting a distal end of a syringe into the port; and The steps include: injecting fluid from a syringe into a port or lumen so that the fluid flows through the lumen and through the sheath; This further involves a step of rinsing off the sheath.
[0023] According to some embodiments of the present invention, a method is provided which includes the steps of: coupling a sheath to a carriage disposed within the shell of a handle; positioning an expandable medical device within the sheath; and coupling the proximal end of a longitudinal element to a stopper disposed within the shell at the proximal end of the carriage. The method further comprises the steps of: positioning an expandable medical device within a sheath; connecting the proximal end of a longitudinal element to a stopper positioned within the shell near the carriage; moving the stopper distally until the distal end of the longitudinal element contacts the expandable medical device; and, after moving the stopper distally, fixing the stopper in place.
[0024] In some embodiments, the inner wall of the shell is molded to define one or more tracks, and the step of moving the stopper distally includes the step of sliding the stopper distally along the tracks.
[0025] In some embodiments, the proximal end of the shell is shaped to define an opening, and the step of moving the stopper distally includes the step of pushing the stopper distally using an extrusion element inserted through the opening.
[0026] In some embodiments, the step of securing the stopper in place includes the step of securing the stopper in place by screwing the stopper into the shell. [Brief explanation of the drawing]
[0027] The present invention will be better understood from the following detailed description of its embodiments with reference to the following drawings: [Figure 1] This is a schematic diagram of a system for treating a subject according to several embodiments of the present invention. [Figure 2] This is a schematic diagram of a handle according to several embodiments of the present invention. [Figure 3] This is a schematic diagram of a handle according to several embodiments of the present invention. [Figure 4-5] Figure 4 is a schematic diagram of a portion of a handle, including a carriage and lever, according to several embodiments of the present invention. Figure 5 is a schematic diagram of a lever and shell, according to several embodiments of the present invention. [Figure 6] This is a schematic diagram of a longitudinal cross-section passing through the distal portion of a handle according to some embodiments of the present invention. [Modes for carrying out the invention]
[0028] (overview) Typically, deploying expandable medical devices such as stents involves retracting the sheath from above the device, exposing it and allowing it to expand. However, the amount of static friction between the sheath and the device can be relatively large, especially if the device has been compressed within the sheath for an extended period. As a result, retracting the sheath in a controlled and stable manner can be challenging.
[0029] To address this challenge, embodiments of the present invention provide a handle configured to deploy an expandable medical device in a two-step process. The handle comprises a lever and a carriage directly or indirectly coupled to a sheath. In the first stage of deployment, the lever is rotated to move the carriage proximally by an initial, relatively short distance. Subsequently, in the second stage of deployment, the lever is slid proximally, thus moving the carriage proximally by a larger, second distance.
[0030] Advantageously, the mechanical advantage provided by the lever during the first stage of deployment facilitates overcoming the frictional force between the sheath and the device. Furthermore, because the carriage movement is restricted during the first stage of deployment, the device is not exposed during this stage. Rather, the device is exposed only during the second stage of deployment in a controlled and stable manner.
[0031] (System description) First, refer to Figure 1, which is a schematic diagram of a system 20 for the treatment of a subject according to some embodiments of the present invention.
[0032] The system 20 comprises a sheath 24. As shown in the insertion portion 25 of Figure 1, which shows the contents of the sheath 24, the sheath is configured to include an expandable medical device 38 in a crimped (non-expanded) configuration. The device 38 may include, for example, a stent (e.g., a mesh stent or a covered stent), a diverter, an aneurysm graft, or a heart valve.
[0033] The system 20 further comprises a handle 22 for deploying the device 38 from a sheath 24 in a body cavity, such as a subject's blood tube. The handle 22 comprises a shell 44, which may be made of plastic or any suitable material, and a lever 40 protruding from the shell 44. When using the handle, a user, such as a physician, typically grasps the shell 44 with one hand, with the thumb of the hand resting on the head 94 of the lever. (Optionally, the head 94 may be shaped to define a ridge to prevent the thumb from slipping off the head.) Alternatively, the user may grasp the head 94 with the other hand.
[0034] Herein, we further refer to Figure 2, which is a schematic diagram of a handle 22 according to some embodiments of the present invention. A portion of the shell 44 is hidden from view in Figure 2 in order to expose the handle components contained within the shell.
[0035] The handle 22 includes a carriage 48 positioned within the shell 44 and configured to connect to the sheath 24. As will be further described below, by operating the lever 40, the user moves the carriage proximal, and thus retracts the sheath 24 from the medical device 38, causing the device to expand inside the body cavity.
[0036] Typically, the carriage is not directly coupled to the sheath but is coupled to the sheath via one or more longitudinal elements. For example, the inner wall of the sheath may be coupled to a rapid replacement tube 32, which may then be coupled to a flexible tube 30. The flexible tube 30 may then be coupled to a reinforcing tube 36, which may be coupled to the carriage. For example, as shown in Figure 6 (described below), the reinforcing tube 36 may be held within the lumen of the carriage by, for example, being bonded to the wall of the lumen. Typically, the flexible tube 30 has a length between 20 cm and 1.5 m so that the expandable device extends from outside the subject to the deployment site.
[0037] The shell 44 is configured to connect to the longitudinal element 26. When the lever retracts the sheath by moving the carriage proximal to the shell 44, the distal end of the longitudinal element 26 remains in contact with the expandable medical device. Thus, the longitudinal element 26 inhibits the contraction of the expandable medical device so that the sheath retracts from the expandable medical device (i.e., the longitudinal element provides a distal reaction force to the medical device).
[0038] Typically, the longitudinal element 26 comprises a flexible wire 27 distally connected to the distal tube 28. Typically, the flexible wire 27 has a length between 20 cm and 1.5 m.
[0039] Before deploying the expandable medical device, the sheath (along with the expandable medical device placed inside it) is typically navigated under fluoroscopy to the location where the device will be deployed. In some embodiments, the sheath is navigated along a guidewire. The guidewire can pass through a guidewire tube 34 that goes through a rapid replacement tube 32 and a distal tube 28.
[0040] Typically, the shell 44 is shaped to define a slit 50, and the lever 40 is configured to move proximal to the slit 50. In some embodiments, the system 20 includes a safety tab 42 which fits into the slit proximal to the lever 40, thereby locking the lever in place; in other words, preventing unintended movement of the lever. Before deploying the expandable medical device, the safety tab 42 is removed from the handle.
[0041] (Deployment of expandable medical devices) Advantageously, as described in the overview above, the handle 22 facilitates the two-stage deployment of the medical device 38.
[0042] During the first stage, the lever 40 is rotated proximal by the rotation indicator 52 as shown in Figure 2. (In the context of this application, including the claims, “proximal rotation” of the lever means rotation of the lever such that the lever head 94 moves proximal.) The rotation of the lever moves the carriage proximal by a first distance d1, which is between 5 and 10 mm in some embodiments. Advantageously, the mechanical advantage provided by the lever facilitates overcoming friction between the sheath and the expandable medical device.
[0043] Typically, in the first stage of deployment, the lever rotates until it contacts the upper surface 96 of the carriage 48, and the carriage prevents the lever from rotating any further.
[0044] In the second stage, the lever slides proximally, as shown in slide display 54 in Figure 2. When the lever is slid, the carriage moves proximally by a second distance d2.
[0045] Typically, the shell 44 is coupled to the longitudinal element 26 via a stopper 46, which is coupled to the inside of the shell (e.g., via a screw 57, as described below) and to the proximal end of the longitudinal element 26 (e.g., via an adhesive inserted through the shell). (The stopper 46 may consist of a piece of material such as a piece of plastic having any suitable shape.) During the second stage of deployment, the carriage 48 is moved proximal until the movement of the carriage is stopped by the stopper 46, for example, thanks to a projection 56 that protrudes upward from the carriage and fits into a complementary recess on the underside of the stopper.
[0046] Typically, the axial position of the stopper 46 (i.e., the position of the stopper along an axis running between the proximal and distal ends of the handle) is adjustable. For example, the inner wall of the shell may be molded to define one or more tracks 47, and the stopper may be configured to slide along the tracks 47. During the assembly of the system 20, the sheath is coupled to the carriage, the expandable medical device is placed inside the sheath, and the proximal end of the longitudinal element is coupled to the stopper. (The following three steps can be performed in any suitable order.) The stopper 46 is then moved distally until the distal end of the longitudinal element 26 contacts the expandable device. For example, the proximal end of the shell may be molded to define an opening 60, and the stopper may be pushed distally by an extrusion element (e.g., a finger or tool) inserted through the opening 60. The stopper is then secured, for example, by inserting a screw 57 through a screw hole 58 in the shell 44 and using the screw to screw the stopper into the shell.
[0047] Generally, expandable medical devices have a distance between the distal end of the device and the distal end of the sheath that is greater than d1 and d2. min-L is positioned within the sheath to be smaller than d2 min d2 is the minimum expected value of d2 after adjusting the stopper, and L is the length of the expandable medical device (e.g., 20, 30, 40, or 60 mm). Because the distance is greater than d1, even with minimal friction between the sheath and the medical device, the device will not come out of the sheath (even partially) in the first stage of deployment. In this case, the sheath is pulled back by d1. min Because it is less than -L, the medical device will exit the sheath in the second stage of deployment, even when there is maximum friction between the sheath and the medical device. In this case, the sheath is not retracted at all in the first stage.
[0048] Typically, the shell consists of a distal arched portion 62 and a proximal straight portion 64. The lever rotates proximally while protruding from the distal arched portion 62, and is typically configured so that the head 94 is at a short distance (e.g., 1–5 mm) from the distal arched portion. The lever further slides proximally while protruding from the proximal straight portion 64, and is typically configured so that the head 94 is at a small distance (e.g., 1–5 mm) from the proximal straight portion.
[0049] Advantageously, the distal arc portion 62 helps the user confirm the moment when the first stage of deployment is complete and the second stage begins. Furthermore, the distal arc portion can facilitate locking the lever before deployment, for example, using a safety tab 42.
[0050] Herein, we refer to Figure 3, which is another schematic diagram of the handle 22 according to some embodiments of the present invention. (As in Figure 2, a portion of the shell 44 is concealed so as not to expose the interior of the handle.) We also refer to Figure 4, which is a schematic diagram of a portion of the handle 22 including the carriage 48 and lever 40 according to some embodiments of the present invention.
[0051] Typically, the lever comprises a neck 41 extending along the longitudinal axis of the lever, and two legs 72 extending along the longitudinal axis of the lever between the neck 41 and the base 71 of the lever. (Thus, the neck 41 connects the legs 72 to the head 94.) Typically, these legs 72 are positioned on opposite sides of the neck 41, and the neck 41 aligns with the slit 50 (Figure 1) while the legs 72 are positioned on opposite sides of the slit below the shell. Thus, in the second stage of deployment, the shell restricts distal rotation of the lever.
[0052] In some embodiments, the leg 72 straddles the distal L-shaped projection 76 of the carriage 48. Before the lever rotates, the vertical proximal-facing surface 77 of the projection 76 contacts the lever, preventing the lever from sliding the carriage 48 in the proximal direction.
[0053] In some embodiments, the lever is shaped to define at least one projection 90, such as the projection 90 on each leg 72 of the lever. Furthermore, the carriage (particularly the upper surface 96) is shaped to define at least one recess 92 configured to receive the projection 90 following the rotation of the lever. For example, the carriage may be shaped to define two recesses 92, each recess 92 aligning with the respective leg 72, so that the recess is configured to receive the projection on the leg. Because the projection fits into the recess, the carriage does not slide proximally away from the lever during the second stage of deployment.
[0054] Typically, the carriage 48 is shaped to define one or more distal projections 68 that contact the lever 40. For example, the carriage may be shaped to define two projections 68, each contacting a different leg 72 of the lever. As the lever rotates, the lever pushes the projections 68, moving the carriage proximal. The distance d1—the distance the carriage 48 moves during the first stage of deployment—can be adjusted by changing the distance d3 between the axis of rotation of the lever and the projections 68. As d3 increases, d1 increases. (Note that the mechanical magnification of the lever d4 / d3; where d4 is the distance from the axis of rotation to the top of the lever; also changes with d3.)
[0055] As an alternative to or addition to the projection 68, the carriage may be molded to define one or more distally projecting racks, and the base 71 of the lever (including, for example, the base of each of the legs 72) may be molded to define one or more pinions that contact the racks. As the lever rotates, the pinions move the racks proximal, thereby moving the carriage.
[0056] It should be noted that, in addition to the distance between the axis of rotation and the point of contact between the lever and the carriage, the distance d1 is a function of the angle of rotation of the lever. In some embodiments, this angle is between 25 and 90 degrees.
[0057] Typically, the handle 22 further comprises an outer carriage 66. In such embodiments, the lever 40 is rotatably coupled to the outer carriage 66 and is configured to move the carriage 48 (which in such embodiments may be called the “inner carriage”) proximal to the outer carriage by a distance d1 (Figure 2) in the first stage of deployment. Subsequently, in the second stage of deployment, the lever moves the inner carriage proximal to the outer carriage by a distance d2.
[0058] In some embodiments, as shown in Figures 3-4, the outer carriage 66 comprises a first carriage wall 66a and a second carriage wall 66b coupled to each other by a distal carriage base 70. Alternatively, the outer carriage may have a single carriage wall coupled to the carriage base 70. The lever 40 is typically coupled to the carriage base 70. For example, the carriage base may include each pin 74 on the opposite side of the carriage base (or a single pin passing through the carriage base), and the base of each leg 72 is attached to the pin 74 such that the pin defines the axis of rotation of the lever.
[0059] In some embodiments, as shown in Figure 3, the outer carriage 66 is shaped to define at least one groove 78, and the inner carriage 48 is shaped to define at least one projection 80 configured to slide within the groove 78 during the first stage of deployment. During deployment, a lever moves the inner carriage proximal to the outer carriage. For example, each of the first carriage wall 66a and the second carriage wall 66b may be shaped to define their respective grooves 78, and the inner carriage may be shaped to define two projections 80 on opposite sides of the inner carriage, so that each projection slides. Alternatively, the inner carriage may be shaped to define at least one groove, and the outer carriage may be shaped to define at least one projection configured to slide within the groove during the first stage of deployment. Advantageously, the aforementioned grooves and projections guide the movement of the inner carriage within the outer carriage.
[0060] Similarly, the shell 44 may be shaped to define at least one groove 82, and the outer carriage 66 may be shaped to define at least one projection 84 configured to slide within the groove 82 while the lever moves the inner and outer carriages proximal to the shell during the second stage of deployment. Alternatively or additionally, the outer carriage may be molded to define at least one groove 86, and the shell may be molded to define at least one projection 88 configured to slide within the groove 86 during the second stage of deployment. For example, each of the first carriage wall 66a and the second carriage wall 66b may be shaped to define their respective projections 84, along with a pair of grooves 86 opposite the projection. Supplementarily, each wall of the shell may be shaped to define a groove 82 into which one projection 84 of the carriage wall slides, along with a pair of projections 88 opposite the groove, which slide within the groove 86 of that wall. Advantageously, the aforementioned grooves and protrusions guide the movement of the outer carriage within the shell.
[0061] In an alternative embodiment, the handle does not include an outer carriage. Rather, the carriage 48 comprises a proximal portion, a distal portion, and a compressible intermediate portion (e.g., including a spring) connecting the proximal portion to the distal portion. During rotation of the lever, the distal portion of the carriage moves toward the proximal portion of the carriage as the central portion is compressed. Subsequently, by sliding the lever, the entire carriage moves in the proximal direction.
[0062] Next, we refer to Figure 5, which is a schematic diagram of the lever 40 and shell 44 according to several embodiments of the present invention. (Other components of the handle, such as the carriage, are omitted from Figure 5.)
[0063] In some embodiments, the base 71 is shaped to define at least one outwardly projecting arcuate projection 98, and the inner wall of the shell is shaped to define at least one inwardly projecting arcuate projection 99. While the lever rotates, the projection 99 is aligned with the projection 98 so as to prevent the base of the lever from sliding proximally. For example, the base of each leg 72 may be shaped to define a respective projection 98, each of which aligns with a different respective projection 99 during the first stage of deployment. When the lever completes its rotation, the projection 98 drops below the projection 99, and as a result, the base of the lever slides freely proximally during the second stage of deployment.
[0064] (Clean the sheath) Here, we refer to Figure 6, which is a schematic diagram of a longitudinal cross-section passing through the distal portion of the handle 22 according to some embodiments of the present invention.
[0065] Typically, the carriage 48 is shaped to define a port 100, such as a female Luer port, configured to receive the distal end of a syringe 102 (for example, through the opening 106 of the shell). (The port 100 is shown in Figure 4.) Typically, the carriage 48 is further shaped to define a lumen 104 that is in fluid contact with the port 100.
[0066] In such embodiments, as described above with reference to Figures 1 and 2, the carriage is configured to connect to the sheath 24 (Figure 1) by gripping the sheath, or another longitudinal element (such as a reinforcing tube 36) connected to the sheath, within the lumen 104. Thus, prior to deployment of the medical device, the sheath can be washed with a fluid such as saline solution injected from a syringe 102. In detail, the fluid is injected into port 100 (and / or directly into lumen 104), and the fluid flows through the lumen into the sheath. For example, the fluid can flow through the sheath via lumen 104, reinforcing tube 36, flexible tube 30, and quick-replacement tube 32, which are coupled to the inside of the sheath as previously described with reference to Figure 1.
[0067] In some embodiments, as shown in Figure 6, the longitudinal element 26 passes through the lumen 104. In such embodiments, a seal 108, such as an O-ring, can be placed around the longitudinal element in the lumen 104 and near the port 100 to obstruct the flow of fluid through the proximal end of the lumen.
[0068] Those skilled in the art will understand that the present invention is not limited to those specifically shown and described herein. The scope of embodiments of the present invention includes, rather than any combination or subcombination of the various features described above, as well as variations and modifications thereof that are not found in the prior art and would be recognizable to those skilled in the art when reading the prior art. Documents incorporated by reference in this patent application are considered integral parts of the application. In the event of any conflict between definitions made expressly or implicitly herein and definitions in incorporated documents, the definitions herein shall prevail.
Claims
1. A device for retracting a sheath from above an expandable medical device: A shell configured to be joined to a longitudinal element; The outer carriage is positioned within the aforementioned shell; An inner carriage positioned within the outer carriage and configured to be coupled to the sheath; and A lever rotatably coupled to the outer carriage and protruding from the shell, While the distal end of the longitudinal element is in contact with the expandable medical device, The steps include: rotating the lever in the proximal direction to move the inner carriage proximal to the outer carriage by a first distance; and The steps include rotating the lever in the proximal direction, followed by sliding the lever in the proximal direction to move the inner carriage together with the outer carriage by a second distance in the proximal direction, A lever configured to retract the aforementioned sheath; An apparatus characterized by having the following features.
2. The apparatus according to claim 1, characterized in that the inner carriage is configured to be coupled to the sheath via one or more other longitudinal elements.
3. The aforementioned inner carriage is: A port configured to receive the distal end of a syringe; and The port and the lumen that communicates fluidly with it; Shaped to define, and The inner carriage is configured to connect to the sheath by gripping the sheath or another longitudinal element connected to the sheath within the lumen, so that the fluid injected from the syringe flows through the lumen through the sheath. The apparatus according to feature 1.
4. The apparatus according to any one of claims 1 to 3, characterized in that the shell is shaped to define a slit, and the lever is configured to rotate and slide proximally within the slit.
5. The apparatus according to any one of claims 1 to 4, characterized in that the shell has a distal arched portion and a proximal straight portion, the lever is configured to rotate in the proximal direction while protruding from the distal arched portion, and the lever is configured to slide proximal while protruding from the proximal straight portion.
6. The apparatus according to any one of claims 1 to 5, characterized in that the first distance is between 5 and 10 mm.
7. The apparatus according to any one of claims 1 to 6, further comprising a stopper within the shell, wherein the shell is configured to be coupled to the longitudinal element by the stopper being coupled to the inside of the shell and to the proximal end of the longitudinal element, and the lever is configured to move the inner carriage in the proximal direction until the movement of the inner carriage is stopped by the stopper.
8. The apparatus according to claim 7, characterized in that the axial position of the stopper is adjustable.
9. The base of the lever is shaped to define at least one outwardly projecting projection, and the inner wall of the shell is shaped to define at least one inwardly projecting projection that aligns with the outwardly projecting projection while the lever is rotating in the proximal direction, and while the lever is rotating in the proximal direction, the inwardly projecting projection prevents the base of the lever from sliding in the proximal direction. The apparatus according to any one of claims 1 to 8.
10. The apparatus according to any one of claims 1 to 9, characterized in that the lever is shaped to define at least one projection, and the inner carriage is shaped to define at least one recess configured to receive the projection following the rotation of the lever.
11. The apparatus according to any one of claims 1 to 10, wherein the inner carriage is shaped to define a distal L-shaped projection, and the lever has two legs that straddle the distal L-shaped projection such that the vertically proximal surface of the distal L-shaped projection contacts the lever before the lever is rotated.
12. A method, The steps include: connecting the sheath to the inner carriage located within the outer carriage located within the shell of the handle; The steps include: placing an expandable medical device within the sheath; The steps include: connecting the proximal end of a longitudinal element to a stopper located within the shell near the inner carriage; The steps include: positioning the expandable medical device within the sheath; connecting the proximal end of the longitudinal element to the stopper located within the shell near the inner carriage; and moving the stopper distally until the distal end of the longitudinal element contacts the expandable medical device; and The steps include: moving the stopper distally, fixing the stopper in a predetermined position; It has, The lever is rotatably coupled to the outer carriage and protrudes from the shell, The aforementioned lever is: While the distal end of the longitudinal element is in contact with the expandable medical device, The steps include: rotating the lever in the proximal direction to move the inner carriage proximal to the outer carriage by a first distance; and The steps include: rotating the lever in the proximal direction, then sliding the lever in the proximal direction to move the inner carriage together with the outer carriage by a second distance in the proximal direction until the movement of the inner carriage is stopped by the stopper; The aforementioned sheath is configured to be retracted, A method characterized by the following:
13. The method according to 12, characterized in that the inner wall of the shell is molded to define one or more tracks, and the step of moving the stopper distally includes the step of sliding the stopper distally along the tracks.
14. The method according to 12 or 13, characterized in that the proximal end of the shell is shaped to define an opening, and the step of moving the stopper distally includes the step of pushing the stopper distally using an extrusion element inserted through the opening.
15. The method according to any one of claims 12 to 14, characterized in that the step of fixing the stopper in a predetermined position includes the step of fixing the stopper in a predetermined position by screwing the stopper into the shell.