Delivery handle for a implant

Abstract

A delivery device for controllably delivering a plurality of implants (e.g., intravascular implants) is described herein. The delivery device can include a locking mechanism to prevent inadvertent implant deployment prior to initial use. The delivery device can also include a resheathing mechanism to allow resheathing of the inner core assembly prior to removal of the delivery device from the initial deployment site. The delivery device can also include a mechanism configured to prevent resheathing of an implant that has been partially deployed.

Description

Technical Field

[0001] This disclosure relates to a device that can be used to place one or more implants (e.g., but not limited to intravascular implants for treating vascular dissections within the vascular system of a subject) in the body of a subject. Technical Background

[0002] There are many medical conditions and surgeries that involve placing implants such as stents in the body to create or maintain pathways. There is a wide variety of stents for different purposes, from expandable coronary artery, vascular, and biliary implants to plastic stents used to allow urine to flow between the kidneys and bladder.

[0003] Stents are typically placed in the vascular system after medical procedures such as balloon angioplasty. Balloon angioplasty is commonly used to treat atherosclerotic obliterative disease (AOD), a leading cause of stroke, heart attack, limb loss, and death in the United States and the industrialized world. Atherosclerotic plaques form a hard layer along the arterial wall and can consist of calcium, cholesterol, dense thrombi, and cellular debris. As AOD progresses, the blood supply to a specific vessel is reduced or even blocked by a process. One of the most widely used methods for treating clinically apparent atherosclerotic plaques is balloon angioplasty, followed by stent placement.

[0004] US10449073B1 discloses a catheter having three concentric shafts, including an inner core, an outer sheath located on the inner core, and an external support shaft extending at least partially on the inner core and the outer sheath. The delivery device is actuated by rotation of a finger wheel coupled to a cylinder having multiple teeth, such that rotation of the finger wheel causes movement of the cylinder, causing the teeth of the cylinder to engage with the teeth of a timing belt, thereby causing movement of the outer sheath. A removable finger wheel locking element is provided to allow rotation of the finger wheel. Summary of the Invention

[0005] This invention is defined by the claims. This disclosure generally relates to means for delivering at least one implant (e.g., an expandable stent), and in some arrangements, to means for delivering multiple implants (e.g., expandable stents) at various target sites within a subject (e.g., within a diseased blood vessel), and examples of related methods are given. This disclosure includes a placement handle of a delivery device (e.g., a delivery catheter) designed to mechanically retract the outer sheath of the delivery catheter in a controlled manner to facilitate delivery or placement of one or more implants mounted on the core of the delivery catheter at spaced locations within a subject (e.g., within a single blood vessel, multiple different blood vessels, or multiple other locations within other body channels or lumens). The placement handle may include an ergonomic design that facilitates single-handed gripping by the operator. The placement handle advantageously improves usability by allowing the operator simple single-handed operation of the placement mechanism while maintaining proper placement accuracy of multiple implants and mitigating the possibility of unintentional, premature placement of implants. The placement handle also advantageously allows the operator to easily place any additional residual implant from the delivery catheter after the core has been re-sheathed at the first target site (at the same or different target sites).

[0006] According to several embodiments of this disclosure, the deployment handle advantageously includes a locking component configured to prevent or reduce the likelihood of premature, accidental deployment or delivery of any implant until the operator intentionally disables the locking mechanism to enable deployment. The locking component advantageously provides a safety feature that prevents or reduces the likelihood of unintentional deployment of any implant from the time of manufacture until the delivery catheter has been advanced into the appropriate target treatment site within the subject. According to several embodiments of this disclosure, the locking component (e.g., the locking lever of the locking component) provides the additional benefit of acting as a tensioner when the locking mechanism is disengaged. The locking mechanism can advantageously be disengaged (e.g., indicating that the device is ready for use) by a single step / action performed by the operator (e.g., pressing down or inward on the locking lever of the locking component), which can also be performed using a single finger or thumb of the operator.

[0007] Multiple embodiments of the deployment handle may include deployment or actuation components or mechanisms (e.g., a roller and belt assembly or a slider assembly) configured to facilitate the withdrawal of the outer sheath of the delivery catheter to deploy one or more implants from the inner core of the delivery catheter. The deployment or actuation components or mechanisms may be configured to allow only withdrawal and not re-insertion. For example, if the deployment or actuation components or mechanisms include a roller and belt assembly, the deployment handle may advantageously include a “reverse roll prevention” feature that allows only rotation of the roller and belt assembly in one direction of rotation (e.g., clockwise) and prevents rotation in the opposite direction of rotation (e.g., counterclockwise), thereby further mitigating unintentional deployment of the implant or damage to the implant or the subject’s body tissues (e.g., blood vessel walls). The deployment or actuation components or mechanisms may also provide the user with tactile and / or auditory feedback (e.g., a click that can be felt and heard) during operation of the deployment or actuation components (e.g., indicating that withdrawal is occurring and the rate of withdrawal).

[0008] According to several embodiments of this disclosure, after the deployment of one or more initial implants, an operator can re-sheath the distal end of the delivery catheter by using the deployment handle to actuate the re-sheath button on the deployment handle and pull back (e.g., in a direction proximal to the operator and away from the main housing body of the deployment handle) the re-sheath housing located proximally to the deployment handle. The deployment handle can be advantageously configured to prevent operation of the deployment mechanism of the deployment handle during the re-sheathing action to prevent unintentional deployment of the implant and / or damage to the implant or the subject's body tissues (e.g., vascular walls) or reduce the likelihood of such damage.

[0009] Once the delivery catheter has been removed from the first target treatment site (or completely from the subject's body), if the delivery catheter still contains an implant, the operator may choose to reinsert the delivery catheter to another target treatment site. To perform this operation, the operator may, for example, guide the delivery catheter to the new target treatment site, actuate the re-sheathing button with one hand, and push the re-sheath housing with the other hand (e.g., in a direction distal to the operator from the main housing body of the deployment handle) until the re-sheath housing engages again with the main housing body of the deployment handle. This operation causes the inner core assembly of the delivery catheter to exit the sheath to the same point, position, or configuration as it was stopped at after the initial implant placement at the first target treatment site before re-sheathing was performed. The deployment handle can then be used to facilitate the delivery of any additional remaining implants to the new target treatment site.

[0010] According to several embodiments of this disclosure, the delivery handle includes a flushing port to facilitate flushing of the various lumens of the delivery catheter prior to insertion into the subject, thereby preventing or reducing the likelihood of air bubbles or cavitation being delivered into the subject's body (e.g., within the subject's vascular system) and / or increasing lubrication. The internal components of the delivery catheter may be specifically configured to facilitate multiple fluid paths through all the multiple lumens and spaces of the delivery catheter, such that flushing fluid travels all the way to the distal end of the delivery catheter, and that air bubbles or cavitation and / or increased lubrication are not retained in the lumens, spaces, or gaps within the delivery catheter after proper flushing.

[0011] According to several embodiments of this disclosure, a delivery device (e.g., a delivery catheter) for delivering one or more implants includes an inner shaft comprising a proximal end and a distal end. The delivery device also includes an outer sheath having a proximal end, a distal end, and a lumen extending from the proximal end of the outer sheath to the distal end of the outer sheath. The outer sheath is movable relative to the inner shaft and / or vice versa. The delivery device also includes a deployment handle (e.g., a rotary deployment handle) configured to cause movement of the outer sheath relative to the inner shaft to facilitate delivery of one or more implants carried by the inner shaft at spaced-apart locations (e.g., within a single treatment area, such as a portion of a blood vessel, or within multiple different treatment areas, such as different blood vessels). The handle includes a deployment actuator (e.g., a fingerwheel configured to be rotated by a user in a first rotational direction, a slider mechanism configured to slide back and forth, or a trigger button configured to be pressed) configured to achieve movement of the outer sheath relative to the inner shaft to extrude a portion of the inner shaft.

[0012] In some embodiments of this disclosure, the handle also includes a locking component configured to prevent rotation of the finger wheel until the locking component is actuated by an operator (e.g., using a single step or operation rather than multiple steps or operations) to switch the finger wheel from a locked configuration (e.g., a configuration in which movement of the outer sheath relative to the inner shaft is impossible or prevented) to an unlocked configuration (e.g., a configuration in which movement of the outer sheath relative to the inner shaft is possible or not prevented).

[0013] The inner shaft of the delivery device may optionally include a lumen extending from the proximal end to the distal end of the inner shaft to facilitate on-wire tracking on the guidewire. Alternatively, the inner shaft may include a lumen extending only a portion of its length (e.g., in a quick-change configuration).

[0014] In some embodiments of this disclosure, the finger wheel is configured to rotate only in a first rotational direction and not in the opposite rotational direction.

[0015] In some embodiments of this disclosure, the delivery device may optionally include a re-sheathing assembly configured to facilitate manual re-sheathing of the inner shaft relative to the outer sheath by pulling the re-sheathing housing coupled to the inner shaft in a proximal direction.

[0016] According to several embodiments of this disclosure, a delivery device for delivering one or more implants includes an inner shaft comprising a proximal end and a distal end. The delivery device also includes an outer sheath having a proximal end, a distal end, and a lumen extending from the proximal end of the outer sheath to the distal end of the outer sheath. The outer sheath is movable relative to the inner shaft and / or vice versa. The delivery device also includes a rotary placement handle configured to cause movement of the outer sheath relative to the inner shaft to facilitate delivery of at least one implant carried by the inner sheath at spaced-out locations. The placement handle includes a roller configured to be rotated by a user in a first rotational direction to achieve movement of the outer sheath relative to the inner shaft, thereby disengaging a portion of the inner shaft. The roller is configured to rotate only in the first rotational direction (e.g., clockwise) and not in the opposite rotational direction (e.g., counterclockwise).

[0017] According to several embodiments of this disclosure, a delivery device (e.g., a delivery catheter) for delivering one or more implants includes an inner shaft and an outer sheath as described above. The delivery device also includes a deployment handle configured to cause movement of the outer sheath relative to the inner shaft to facilitate delivery of at least one implant carried by the inner sheath. The delivery device further includes a re-insertion assembly configured to facilitate re-insertion of the inner shaft relative to the outer shaft by manually pulling a re-insertion housing coupled to the inner shaft in a proximal direction. In other configurations, the re-insertion housing may be coupled to the outer sheath such that the outer sheath can be moved relative to the inner shaft for re-insertion.

[0018] The delivery device may also include a deployment actuator, such as a finger wheel, configured to be rotated by a user in a first rotational direction to move the outer sheath relative to the inner shaft, thereby disengaging a portion of the inner shaft. The finger wheel may be coupled to a belt / pulley assembly. The delivery device may optionally pre-load one or more implants onto the inner shaft.

[0019] According to several embodiments of this disclosure, a delivery device (e.g., a delivery catheter) for delivering multiple implants includes an inner shaft and an outer sheath, and a lumen extending from a proximal end of the outer sheath to a distal end of the outer sheath, with the inner shaft located within the lumen. The delivery device also includes a placement handle configured to cause movement of the outer sheath relative to the inner shaft to facilitate delivery of multiple implants carried by the inner shaft at spaced-apart locations. The placement handle includes an elongated main housing including a proximal end, a distal end, and a upper surface. The placement handle also includes a placement actuator configured to cause movement of the outer sheath relative to the inner shaft. The placement handle further includes a re-sheathing assembly configured to facilitate re-sheathing of the inner shaft after placement of one or more implants at a treatment area and before removal (or complete removal from the body) of the delivery device from the treatment area within the subject. The re-sheathing assembly includes a re-sheathing housing removably coupled to the proximal end of the main housing of the rotary deployment handle, a re-sheathing button positioned adjacent to the proximal end of the main housing and located distal to the re-sheathing housing, and a re-sheathing rack disposed within the main housing of the rotary deployment handle. The proximal end of the re-sheathing rack may be fixedly (e.g., permanently) coupled to the re-sheathing housing, and the inner shaft may be operably coupled to the re-sheathing housing such that retraction of the re-sheathing housing in a proximal direction away from the main housing causes the re-sheathing rack and the inner shaft to move in the proximal direction, thereby allowing the inner shaft to re-enter the outer sheath.

[0020] In some embodiments of this disclosure, the re-insertion button is configured to prevent longitudinal movement of the re-insertion housing and re-insertion rack unless the operator presses the re-insertion button into the main housing. A deployment actuator may include a finger wheel extending from the upper surface of the main housing. The finger wheel may include a plurality of teeth configured to engage links of a belt operatively coupled to the outer sheath to allow movement of the outer sheath relative to the inner shaft as the finger wheel rotates. In some embodiments of this disclosure, proximal movement of the re-insertion rack during re-insertion causes the finger wheel to be switched to a locked configuration, such that rotation of the finger wheel is prevented during re-insertion. The delivery device may optionally include one or more flushing ports extending proximal to the re-insertion housing to facilitate flushing of the lumen of the inner shaft and the lumen of the outer sheath. The inner shaft of the delivery device may include a lumen extending proximal to distal (e.g., to facilitate tracking of the delivery device located on the guidewire).

[0021] According to several embodiments of this disclosure, a delivery device for delivering one or more implants includes an inner shaft having a proximal end and a distal end. The delivery device also includes an outer sheath having a proximal end, a distal end, and a lumen extending from the proximal end of the outer sheath to the distal end of the outer sheath. The delivery device further includes a rotary placement handle configured to cause movement of the outer sheath relative to the inner shaft to facilitate delivery of at least one implant carried by the inner shaft (e.g., one implant, two implants, three implants, four implants, or more than four implants). The rotary placement handle includes a finger wheel and a belt and pulley assembly operably coupled to the finger wheel and the outer sheath, such that rotation of the finger wheel causes movement of the outer sheath relative to the inner shaft. The rotary placement handle also includes a locking assembly configured to: (a) cause the finger wheel to change from a locked configuration in which the finger wheel cannot rotate to an unlocked configuration in which the finger wheel can rotate, and (b) sufficiently tension the belt during the transition from the locked configuration to the unlocked configuration.

[0022] The deployment assembly may also include a shuttle or belt link that surrounds a portion of the length of the outer sheath. The shuttle may be engaged with the outer sheath and configured to cooperate or engage with the belt so that the outer sheath can be moved as the belt moves in response to the rotation of the pulley.

[0023] In some embodiments of this disclosure, the deployment handle further includes a ratchet, which includes teeth configured to be operably coupled to the teeth of the finger wheel. The angles of the teeth of the finger wheel and the teeth of the ratchet can be shaped and configured to prevent rotational movement of the finger wheel in a direction opposite to the normal operating direction of rotation (e.g., counterclockwise). In some embodiments of this disclosure, the deployment handle includes a ratchet, which includes teeth configured to be operably coupled to the teeth of the finger wheel to provide tactile feedback and / or an audible clicking sound to the operator when the operator rotates the finger wheel. The audible clicking sound can indicate to the operator the rate (e.g., speed) of deployment, thereby allowing the operator to slow down the deployment if necessary.

[0024] In some embodiments of this disclosure, the locking assembly includes a locking lever (e.g., a shelf lock). The locking lever includes a proximal portion extending from the main housing of the rotary dispenser handle and a distal portion fixedly coupled to the main housing of the rotary dispenser handle when the locking assembly is in a locked configuration. When the locking lever is in a locked configuration, the locking lever can conceal the dial.

[0025] The locking assembly may also include a locking plate comprising a proximal abutting surface configured to interface with a protrusion (e.g., a bump) of the locking lever. The locking plate may also include a plurality of engaging members (e.g., heads) configured to interface with one or more recesses between the gear teeth of the finger wheel to prevent rotation of the finger wheel when the locking assembly is in a locked configuration. The locking plate may be biased by a spring (e.g., a torsion spring) or other biasing member such as an elastic band to move proximal to the rotary release handle.

[0026] In some embodiments, when an operator presses the proximal end of the locking lever into the main housing, the locking assembly is switched to an unlocked configuration by disengaging the proximal abutment surface of the locking plate from the proximal abutment surface of the locking lever, thereby moving the locking plate proximally (as if it were spring-biased). This allows the proximal engagement member of one of the plurality of engagement members (e.g., the head) of the locking plate to disengage from the finger wheel (e.g., a gear tooth / recess), thereby allowing the finger wheel to rotate.

[0027] In some embodiments of this disclosure, the delivery device further includes a resheathing assembly configured to facilitate resheathing of the inner shaft before removing the delivery device from the delivery location within the subject's body. The resheathing assembly may include a resheathing housing removably coupled to a proximal end of the main housing of the rotary delivery handle, a resheathing button disposed adjacent to the proximal end of the main housing and located distal to the resheathing housing, and a resheathing rack disposed within the main housing of the rotary delivery handle.

[0028] In some embodiments of this disclosure, the re-insertion button is configured to prevent longitudinal movement of the re-insertion housing and the re-insertion rack unless the operator presses the re-insertion button into the main housing. The proximal end of the re-insertion rack may be fixedly coupled (e.g., permanently attached) to the re-insertion housing, and the inner shaft may be operably coupled to the re-insertion housing such that retraction of the re-insertion housing in a proximal direction away from the main housing causes the re-insertion rack and the inner shaft to move in a proximal direction, thereby allowing the inner shaft to re-enter the outer sheath.

[0029] The engaging protrusion at the distal end of the locking plate can be configured to engage with the distal end of the re-insertion rack, such that the locking plate is prevented from moving proximally when the re-insertion rack is in its most distal position within the main housing. In some embodiments, during re-insertion, as the re-insertion rack moves in the proximal direction, the engaging protrusion at the distal end of the locking plate is no longer constrained by the distal end of the re-insertion rack to prevent proximal movement, and thus moves in the proximal direction until the distal engaging member of the locking plate engages with one or more recesses between the teeth of the finger wheel, thereby preventing the finger wheel from rotating during re-insertion. As previously described, the locking plate can be biased by a spring or other biasing member to move in the proximal direction.

[0030] The rotary handle may also include multiple flushing ports extending outward from the proximal end of the rotary deployment handle to facilitate flushing of the lumen of the inner shaft and the lumen of the outer sheath. The inner shaft may include a lumen (e.g., a guidewire lumen) extending from the proximal end of the inner shaft to the distal end to facilitate wire delivery. The inner shaft may include multiple delivery platforms disposed along the inner shaft toward the distal end, each of the multiple delivery platforms including a recess extending distal to a radially projecting portion.

[0031] A system may include a delivery device as described herein in conjunction with a plurality of implants. Each of the plurality of implants may be positioned around a corresponding delivery platform among a plurality of delivery platforms. The system may be configured to place at least two of the plurality of implants at spaced-apart locations in a treatment area such that a minimal gap is provided in the treatment area between the distal end of the proximal implant and the proximal end of the distal implant, without requiring movement of the plurality of delivery platforms between the placement of the at least two implants. The plurality of implants may include at least two identical implants, or all of the plurality of implants may be identical. The plurality of implants may include implants of different shapes or sizes (e.g., lengths).

[0032] According to several embodiments, a method for delivering implants at multiple different treatment sites within a subject is given as an example. The method includes advancing a delivery catheter into a first treatment site within the subject. The delivery catheter includes an inner shaft and an outer sheath concentrically surrounding the inner shaft. The inner shaft and outer sheath are configured to move relative to each other (e.g., one can be axially translated forward or backward relative to the other). Multiple implants may be loaded at spaced-apart locations along the length of the inner shaft (during manufacturing or before use). The method further includes disembarking a first batch of one or more implants by proximally moving the outer sheath while keeping the inner shaft stationary, thereby placing the first batch of one or more implants (e.g., two implants) at the first treatment site within the subject. The method also includes re-sheathing a portion of the inner shaft corresponding to the location of the first batch of one or more implants by proximally moving the inner shaft while keeping the outer sheath stationary, thereby improving subject safety as the delivery catheter is moved to a second treatment site within the subject. Re-sheathing can be achieved by an operator pulling the re-sheath housing of a rotary deployment handle proximally. The method also includes advancing the delivery catheter to a second treatment site within the subject and disengaging a portion of the inner shaft corresponding to the position of the first batch of one or more implants by distally moving the inner shaft while keeping the outer sheath stationary, such that the distance between the distal end of the outer sheath and the distal end of the inner shaft is the same as the distance after the first batch of one or more implants was deployed. Disengagement can be achieved by the operator pushing the re-insertion housing of a rotary deployment handle distally. The method may also include disengaging a second batch of one or more implants by proximally moving the outer sheath while keeping the inner shaft stationary, and deploying a second batch of one or more implants (e.g., two implants) at the second treatment site within the subject. Disengagement can be achieved by the operator rotating a finger wheel.

[0033] The implant may include, but is not limited to, self-expanding intravascular implants. The first treatment site may be the location of one or more first vascular dissections, and the second treatment site may be the location of one or more second vascular dissections. The first and second treatment sites may be located in the same blood vessel or in different blood vessels (e.g., arteries, veins, capillaries). The implant may be delivered to more than two treatment sites. The treatment site may be located above or below the knee. Treatment sites are not limited to the leg but may include locations in the arm, coronary vascular system, neurovascular system, peripheral vascular system, coronary vascular system, or other vascular systems. Alternatively, the treatment site may be located in other body cavities, passageways, or pathways besides the vascular system. Attached Figure Description

[0034] For illustrative purposes, various embodiments are illustrated in the accompanying drawings and should not be construed as limiting the scope of the invention, wherein the same reference numerals always denote corresponding features in all similar embodiments.

[0035] Figure 1 This is a side view of a delivery device used to deliver multiple implants in a controlled manner.

[0036] Figure 2 yes Figure 1 A view of the distal end of the delivery device, where the outer sheath retracts to show multiple implants mounted on the inner shaft of the delivery device.

[0037] Figure 3 It shows that it can be used Figure 1 An example of a delivery device for delivering an intravascular implant. The intravascular implant is shown in a coiled or compressed state.

[0038] Figure 3A It is in an unconstrained or uncompressed state. Figure 3 A close-up view of a portion of the implant.

[0039] Figure 4 yes Figure 1 A perspective view of the rotary deployment handle of the delivery device.

[0040] Figure 5 It shows Figure 4 An exploded assembly diagram of several parts of the rotary deployment handle.

[0041] Figure 6 yes Figure 4 A side view of the rotary deployment handle, with the left side housing portion removed.

[0042] Figures 7A to 7D It shows Figure 4 Various configurations of the rotary deployment handle. Figure 7A and Figure 7B A side view of the internal components is shown when the finger wheel is in the locked configuration. Figure 7C and Figure 7D A side view of the internal components is shown when the finger wheel is in the unlocked configuration.

[0043] Figure 8 It shows Figure 4 The right-side view of the internal components of the rotary deployment handle, with the right-side housing portion removed. Figure 8A This is an exploded close-up view showing the interaction between the ratchet and the finger wheel of the rotary release handle.

[0044] Figure 9 yes Figure 4Left view of the rotary deployment handle, with the left side housing removed. Figure 9 The internal components involved in the resheathing function of the rotary deployment handle are shown. Figure 9A yes Figure 9 A close-up view of a portion of it.

[0045] Figure 10 yes Figure 4 The left-side view of the rotary deployment handle shows the internal components and the left-side housing portion has been removed. Figure 10A Close-up side sectional views of each internal component are shown. Figure 10B This is a close-up side view of the shuttle clamp that facilitates the connection of the belt and the shuttle. Figure 10C This is a close-up side sectional view of the flushing port of the rotary dispensing handle. Figure 10D and Figure 10E It is a close-up side cross-sectional view showing the fluid passage of the lumen of the delivery catheter, which facilitates fluid flushing.

[0046] Figures 11 to 15 It shows Figure 1 An example of how to use the delivery device. Detailed Implementation

[0047] A. Introduction

[0048] Based on several embodiments of this disclosure, apparatus and related methods for delivering one implant (e.g., one expandable stent) and / or multiple implants (e.g., multiple expandable stents) at various target sites within a subject (e.g., within a diseased blood vessel) are described herein. This disclosure includes descriptions of structural components and functions of various configurations or embodiments of a delivery device (e.g., a delivery catheter) with a rotary placement handle designed to mechanically retract the outer sheath of the delivery catheter in a controlled manner to facilitate the delivery or placement of one or more implants at spaced-apart locations within a subject (e.g., within a single blood vessel, multiple different blood vessel locations, or multiple other locations within other body channels or lumens).

[0049] Several embodiments of this disclosure are particularly advantageous because they include one, more, or all of the following advantages: (i) improved ease of use by allowing the operator simple one-handed operation of the placement mechanism; (ii) maintained accuracy in the proper placement of multiple implants; (iii) reduced likelihood of unintentional, premature placement of implants; (iv) efficient and simple placement of remaining implants from the delivery catheter after re-insertion has been performed (at the same or different target sites); (v) reduced likelihood of unintentional re-insertion of partially placed implants; (vi) reduced likelihood of damage to implants or body tissues; (vii) prevention of placement or delivery of any implants until the operator intentionally disables the shelf locking mechanism to enable initial implant placement; (viii) increased lubricity of the delivery catheter; and / or (ix) reduced likelihood of air bubbles being introduced into the subject's vascular system through the delivery catheter.

[0050] Multiple configurations of the placement handle for the delivery catheter may include a roller and belt assembly configured to facilitate the deployment of an implant from the inner core of the delivery catheter by unsheathing of the outer sheath. The placement handle may advantageously include features that allow only rotation of the roller and belt assembly in one direction of rotation (e.g., clockwise) and prevent rotation in the opposite direction of rotation (e.g., counterclockwise), thereby further mitigating unintentional placement of the implant or damage to the implant or the subject's body tissues (e.g., blood vessel walls). The placement handle may also include a locking mechanism configured to prevent rotation of the roller until the locking mechanism is actuated by the operator to change the roller from a default locked configuration (as set during initial manufacturing or assembly) to an unlocked configuration in which implant placement is permitted. The locking mechanism can be disengaged by a simple, single step or operation performed by the operator.

[0051] According to multiple embodiments, after deploying one or more initial implants, an operator can re-sheath the distal end of the delivery catheter (the exposed area of ​​the previously deployed implant) by actuating the re-sheathing button on the deployment handle and pulling back (e.g., proximal to the main housing body away from the deployment handle, or toward the operator) the re-sheath housing using the deployment handle. The deployment handle can be advantageously configured to prevent operation of the deployment mechanism of the deployment handle during the re-sheathing action, thereby again preventing unintentional deployment of the implant and / or damage to or reduction of the likelihood of damage to the implant or the subject's body tissues (e.g., vascular walls).

[0052] Once the delivery catheter has been removed from the primary target treatment site or completely from the subject's body, if the delivery catheter still contains an implant, or after the insertion of another implant, the operator may choose to reinsert the delivery device to another target treatment site. The deployment handle can then be used to facilitate the delivery of any of the remaining implants. The re-insertion process during the initial implant deployment facilitates the repositioning of the distal ends of the inner shaft and outer sheath to their respective positions before disengagement, thus improving efficiency and ease of use.

[0053] B. Delivery catheter

[0054] Figure 1 An embodiment of a delivery device 1 that can be used to sequentially deliver multiple implants 2 in a controlled manner is shown. The delivery device 1 may also be referred to herein as a delivery catheter. According to various embodiments, the delivery device 1 can be used in, but is not limited to, surgical procedures for treating atherosclerotic occlusive disease. The delivery device 1 can be used to deliver one or more implants 2 to a site of plaque accumulation (e.g., one, two, three, four, or more than four implants). The implants 2 can stabilize the site and / or keep the plaque from obstructing blood flow. It should be understood that although the delivery devices and methods described herein are primarily described with reference to vascular surgery and the treatment of vascular dissection, they can also be used to treat other conditions and other parts of the body. Furthermore, while the delivery device 1 has certain features particularly useful for delivering multiple implants, certain features of the delivery device can also be used in devices configured to deliver a single implant.

[0055] For ease of illustration, Figure 1The delivery device 1 has been shortened, highlighting the distal portion 4 and proximal portion 6 of the delivery device 1. The length of the delivery device 1 can vary as needed and / or desired. In various embodiments, the length can range from 50 cm to 250 cm (e.g., overlapping ranges from 50 cm to 100 cm, from 80 cm to 120 cm, from 100 cm to 200 cm, from 120 cm to 180 cm, from 140 cm to 160 cm, from 150 cm to 250 cm, from 180 cm to 220 cm, from 200 cm to 250 cm, or any value within the listed range). The proximal portion 6 includes a placement handle 10, which can be held with one hand by a physician or other medical professional during medical procedures. The proximal portion 6 can be configured in various ways, such as an integrated handle assembly (as shown) or a "pin and pull" configuration (not shown). The placement handle 10 can be used to control the delivery of one or more implants 2 (e.g., sequential or simultaneous delivery). The delivery device 1 also includes a catheter assembly 11 extending from the deployment handle 10 to the distal portion 4 of the delivery device 1. The delivery device 1 may optionally include a strain relief section 30 to facilitate the transition between the deployment handle 10 and the catheter assembly 11. The strain relief section 30 may take various forms and be made of various materials, such as polyolefins or other similar materials.

[0056] Figure 2 The distal portion 4 of the delivery device 1 and the catheter assembly 11 are shown. The catheter assembly 11 includes an outer sheath 12 and an inner core assembly 13. As shown, the inner core assembly 13 is loaded with six implants 2, each positioned at a dedicated delivery platform 8. Although Figure 1 and Figure 2 A delivery device 1 with six implants and six dedicated delivery platforms is shown, but delivery device 1 may include more or fewer implants 2 and delivery platforms 8 (e.g., 1, 2, 3, 4, 5, 7, 8, or more than 8 implants 2 and delivery platforms 8). The inner core assembly 13 may include one or more components. For example, the inner core assembly 13 may include an elongated inner shaft 26 comprising a lumen configured to facilitate coaxial advancement on a guidewire and a pusher tube 29 concentrically surrounding the elongated inner shaft 26 (e.g., coaxial with it). Figure 5 (As shown). In some embodiments, the actuator tube 29 may comprise a polyetheretherketone (PEEK) tube. However, other polymers or metals may also be used. The inner core assembly 13 may also include a delivery tube (e.g., delivery tube 51, described elsewhere herein).

[0057] Compare Figure 1 and Figure 2 It can be seen that in Figure 2The outer sheath 12 has been retracted by the distal end of the delivery device 1. This retraction of the outer sheath 12 reveals the delivery platform 8 and the corresponding implant 2 mounted on the inner core assembly 13. The implant 2 may be self-expanding and is shown in its compressed position, state, or configuration to indicate how it will be fitted into the delivery platform. In use, when in such a compressed position, state, or configuration, the outer sheath 12 may cover the implant 2. The outer sheath 12 may retract in a systematic, controlled manner to deploy one implant 2 at a time at one or more intended treatment sites or locations, as the implant 2 may self-expand once withdrawn from the outer sheath 12. Advantageously, the delivery device 1 can be used to implant relatively small implants that can be delivered to precise treatment locations and appropriately spaced to avoid overlap. It should be understood that the delivery device and the method given for example may also be used with other medical devices, including larger devices, and are not limited to use with the endoluminal or intravascular implant 2 described herein.

[0058] like Figure 2 As shown, the delivery catheter may include a distal end 38, which includes a tapered nasal cone and may be made of a soft material. According to several embodiments, the end 38 may advantageously serve as an expansion structure to non-invasively displace tissue and help guide the delivery catheter 1 through the vascular system or other body lumens, channels, or passages. The end 38 itself may be radiopaque, or may include radiopaque elements (not shown) contained within or near the end.

[0059] Figure 2 The document also illustrates multiple parts of one of the delivery platforms 8. Delivery platforms 8 may be identical or substantially identical, although other embodiments of this disclosure may have delivery platforms 8 of different sizes and configurations. A coiled or compressed implant 2 is shown in delivery platform 8. Similarly, implants positioned on delivery platform 8 may be identical or substantially identical, although implants 2 may be of different sizes and configurations in other embodiments of this disclosure.

[0060] As in Figure 2As can be seen, one or more delivery platforms 8 may be disposed on the inner shaft 26 adjacent to the distal portion 4 of the delivery catheter 1. Each delivery platform 8 may include a recess positioned between a pair of annular pusher bands 27. In the embodiment shown in this disclosure, the proximal annular pusher band 27A of the first platform 8A is also the distal annular pusher band 27A of the platform 8B disposed proximally adjacent to it. The annular pusher bands 27 have a larger outer diameter compared to the delivery platforms 8 at the recess. In some embodiments of this disclosure, the recess may be defined as an additional feature located near or between one or two annular pusher bands 27 and / or on the inner shaft 26, representing a smaller diameter region. In improved arrangements of the delivery catheter, the recess may be eliminated by providing another structure for axially securing the implant 2 along the inner shaft 26 (e.g., a stud or interlocking member engaging the corresponding implant 2).

[0061] One or more annular pusher bands 27 can also be used as radiopaque marking bands. For example, proximal and distal radiopaque marking bands can be provided to make the ends of the respective platforms 8 visible using standard angiography or other visualization techniques, and thus indicate to the user the position of the implant 2 on the delivery catheter 1. The annular pusher bands 27 can take any suitable form, including, for example, one or more of tantalum, iridium, and platinum materials. In some embodiments of this disclosure, the pusher bands 27 may be approximately 4 mm long and have recesses of approximately 12 mm between them. In such embodiments of this disclosure, the axial length of the implant (e.g., in a coiled configuration) between 4 and 15 mm (e.g., overlapping ranges between 4 and 12 mm, 8 and 12 mm, 4 and 9 mm, and 10 and 11 mm, or any value within the listed ranges, including 4.5 mm, 5.0 mm, 5.5 mm, 6.0 mm, 6.5 mm, 7.0 mm, 7.5 mm, 8.0 mm, 8.5 mm, 10.3 mm, 10.5 mm, 11 mm, 11.5 mm, and 12 mm) can be positioned between the pusher bands 27. In some embodiments, the pusher bands 27 can be between 50 and 70% of the size of the recess and / or implant. In some embodiments, the pusher bands 27 are approximately 60% of the size of the recess and / or implant. In other embodiments, the pusher bands 27 can be much smaller, between 10 and 20% of the size of the recess and / or implant. This is particularly likely for longer implants. In some embodiments, at least the proximal end of the pusher band 27 may have a radius to help reduce the likelihood of it getting stuck on the placed implant during retraction of the delivery catheter 1. The pusher band 27 may be in the range of 10% to 75% of the size of the recess and / or implant (e.g., between 10% and 20%, between 10% and 30%, between 15% and 30%, between 10% and 50%, between 20% and 50%, between 25% and 75%, between 30% and 60%, between 10% and 40%).

[0062] Reducing the length difference between the recess and the implant can improve implant placement accuracy, especially for implants with only one, two, three, or four rows of units. In some embodiments of this disclosure, a row of units can be defined as a pair of rings, and each ring can be formed by a series of pillars and vertices that can form a repeating pattern. In such embodiments, implants with one, two, three, or four rows of units can be formed by two, three, four, or five rings, respectively. In some embodiments of this disclosure, the recess can be longer than the implant by less than 1, 0.5, 0.4, 0.3, 0.25, or 0.2 mm. The implant can be any number of different sizes, for example, with axial lengths of 4, 5, 6, 6.5, 8, 10, or 12 mm.

[0063] Figure 3 and Figure 3A An exemplary embodiment of an implant 2 that can be delivered by delivery device 1 is shown. This is a relatively small intraluminal device, for example, one with only one row (such as...). Figure 3 and Figure 3A (As shown), two or three rows of units can be delivered at precise treatment locations and appropriately spaced to avoid overlap. Figure 3A It shows Figure 3 The flattened portion of the implant (e.g., an intravascular or intraperitoneal implant). It can be seen that the single-row unit 14 is formed by two concentric rings of corrugated struts 16 connected by a bridging member 18. In the illustrated embodiment, the bridging member 18 has a pair of anchors 20 and radiopaque markers 22. However, other embodiments of the implant do not include anchors. Multiple small intravascular implants can be used to treat single or multiple lesions. This can minimize the number of foreign bodies in the body while providing the required retention force. Various embodiments of the implant are described in more detail in the applicant’s related applications (e.g., U.S. Patent Application No. 13 / 179,458, filed July 8, 2011, published as US2012 / 0035705; U.S. Patent Application No. 13 / 749,643, filed January 24, 2013, published as US2013 / 0144375; U.S. Provisional Application No. 62 / 901,193, filed September 16, 2019; and PCT Application No. PCT / US2020 / 029351, filed April 22, 2020, published as WO2020 / 219567).

[0064] Each radiopaque marking can be press-fitted or forged into a circular orifice on the corresponding bridge member of the in-lumen device. Forging is a forging process in which the dimensions of the article are altered using a die (in which the article is forced). Forging is typically a cold working process; however, it is sometimes done as a hot working process. Forging is often the preferred method for precious metals because there is no material loss in the process. The radiopaque markings discussed herein concerning in-lumen devices and delivery devices can be made of any number of different materials, including gold, platinum, and tantalum.

[0065] In some configurations, the outer sheath 12 may be constructed as a laminate formed of a polymer extrusion and braided threads embedded in the polymer extrusion. Flexibility and stiffness can be controlled by the number of braided threads, the braiding pattern, and the braiding pitch. In one embodiment, the outer sheath 12 may be made of polyether block amide (PEBA), a thermoplastic elastomer (TPE) available under the trade name PEBAX.

[0066] In some configurations, the outer sheath 12 has a thinner inner liner made of polytetrafluoroethylene (PTFE) (e.g., TEFLON) or PEEK material. Any translucent marking strip 28 or other translucent material may be positioned between these two layers. In other embodiments of this disclosure, the translucent marking strip 28 or other translucent material may be embedded within one or more layers of the outer sheath 12. The width of the translucent marking strip 28 may range from 0.5 mm to 5 mm and may be positioned 0.5 mm to 10 mm proximal to the distal end of the outer sheath 12. In some embodiments of this disclosure, the translucent marking strip 28 may be 1 mm wide and positioned 6 mm proximal to the distal end of the outer sheath 12.

[0067] In some embodiments, the catheter assembly 11 includes an outer support shaft composed of PEEK or other extruded flexible polymer and configured to provide support for a smaller diameter outer sheath 12, thereby forming a triaxial catheter assembly. In some embodiments, the outer support shaft and inner shaft 26 are positioned proximally at the deployment handle 10, and the outer sheath 12 translates coaxially on the inner shaft 26 and within the outer support shaft. The diameter of the outer sheath 12 may taper from proximal to distal. The taper may be uniform along its entire length or may have a constant diameter portion that tapers along its length.

[0068] In other embodiments of this disclosure, the outer sheath 12 is formed of a sodium hypochlorite tube, such as a metal or plastic sodium hypochlorite tube. The flexibility and stiffness of the sodium hypochlorite tube outer sheath 12 can be controlled by a number of features, such as the bevel and frequency of the helical cuts along the length of the sodium hypochlorite tube. The bevel and frequency can be uniform or can vary along the length of the sodium hypochlorite tube. Different sections of the length of the sodium hypochlorite tube can be designed to be more flexible than other sections.

[0069] For example, delivery device 1 can be used as part of a surgical procedure to treat atherosclerotic occlusive disease. Delivery device 1 can be used to deliver one or more implants to the site of plaque accumulation; these implants may also be referred to herein as endovascular implants, such as stents. Intravascular implants can stabilize the site and / or keep the plaque plaque from obstructing blood flow. Delivery device 1 is positioned relative to a self-expanding endovascular implant (e.g., a stent). Figures 1 to 3AThe description is based on the delivery of those shown herein. It should be understood that although the implants and methods described herein are primarily referred to in relation to vascular surgery (e.g., above- or below-knee angioplasty) and intravascular implants, certain features and aspects of the embodiments disclosed herein can also be used to treat other parts of the body (e.g., other body lumens, channels, spaces, chambers) and / or to deliver other types of implants or medical devices (e.g., U-shaped staples, plugs, sutures, grafts, anchors). In some embodiments, the delivery device may be introduced via alternative delivery routes, not just intravascular (e.g., percutaneous, laparoscopic, endoscopic, open surgical methods).

[0070] C. Place handle

[0071] 1. Overview

[0072] Figure 4 yes Figure 1 A close-up perspective view of the rotary placement handle 10 at the proximal portion 6 of the delivery device. Figure 4The external components of the placement handle 10, visible to the operator, are shown. In the illustrated embodiment, the external components of the handle 10 include a main body housing 40, a locking lever 42, a ring wheel 44, a re-sheath housing 46, a re-sheath button 47, and flushing ports 48, 49. The main body housing 40 may be ergonomically shaped to facilitate one-handed grip by the operator. The locking lever 42 extends into an upper opening in the main body housing 40 and forms the upper proximal surface of the handle 10. The locking lever 42 may be part of a locking assembly configured to prevent unintentional placement of any implant until the operator intentionally disables the locking mechanism, which can be done by a single step or operation performed by the operator. The structural components and function of the locking mechanism will be described in more detail later. The ring wheel 44 extends from the upper surface of the locking lever 42. According to several embodiments of this disclosure, when the locking lever 42 is in the raised position, the locking lever 42 physically conceals the ring wheel 44, thereby indicating to the user or operator that the locking lever 42 must be pressed inward (e.g., downward) to use the delivery device 1. Locking lever 42 may include printed arrows or other markings to indicate to the operator to press inward (e.g., downward) onto locking lever 42 to initiate use. Grip 44 is a component of the deployment mechanism configured to retract the outer sheath 12 to facilitate the deployment of the implant 2. Re-sheath housing 46 is removably coupled to the proximal end of the main body housing 40 and facilitates re-sheathing by retracting the inner shaft 26 into the outer sheath 12 when the operator wishes to move the delivery device 1 to another location after the deployment of one or more implants. Re-sheath button 47 extends from the bottom surface of the main body housing 40 and enables / disables the re-sheathing function, as well as unsheathing after re-sheathing. The structural components and function of re-sheathing will be described in more detail later. Flushing ports 48, 49 extend from the proximal surface of re-sheath housing 46. Flushing ports 48, 49 are proximal Luer sleeves 50 ( Figure 5 The ports (shown in the diagram) facilitate flushing of the various cavities and spaces within the delivery device 1 before use, which will be described in more detail later.

[0073] Figure 5 An exploded assembly diagram of several components of an embodiment of the rotary deployment handle 10 is shown. (See attached diagram.) Figure 5 As shown, Figure 4The main housing 40 may include a two-part housing: a right housing portion 40A and a left housing portion 40B. The re-sheath housing 46 may also include a two-part housing: a right re-sheath housing 46A and a left re-sheath housing 46B. The two portions of the main housing 40 and the re-sheath housing 46 may be configured to snap together during assembly via various corresponding mating members. The inner shaft 26 is configured to be received within the distal opening of the proximal Luer sleeve 50. The delivery tube 51 is coaxially surrounding the inner shaft 26. In some embodiments, the delivery tube 51 may comprise stainless steel or other biocompatible polymers and / or metal materials. The locking assembly of the illustrated handle 10 includes a locking lever 42 and a locking plate 52.

[0074] like Figure 5 As further shown, the finger wheel 44 also comprises two parts: a right finger wheel 44A and a left finger wheel 44B. The deployment mechanism of the deployment handle 10 also includes a ratchet 54, a ratchet spring 55, a retraction belt 56, multiple pulleys 57, multiple shafts 58, and belt links or a shuttle 59. The shuttle 59 interfaces with or interacts with multiple components, including an outer sheath sleeve 59A, an O-ring 59B, and a shuttle clip 59C. Figure 5 Two additional components of the re-sheathing mechanism are also shown: a re-sheathing rack 60 and a re-sheathing button spring 61, which are configured to bias the re-sheathing button 47 to a default rest position that prevents re-sheathing from being performed or prevents it from being re-sheathed.

[0075] Figure 6 This is a side view of the rotary deployment handle 10, with the left housing portion 40B removed and showing several internal components of the assembled rotary deployment handle 10. Figure 6 The diagram shows the finger wheel 44, the locking lever 42 and locking plate 52 of the locking assembly / mechanism, the retraction belt 56, the pulley 57, the re-sheathing rack 60 and re-sheathing button 47 of the re-sheathing mechanism, and the flushing ports 48 and 49 of the proximal Luer sleeve 50.

[0076] Figure 6 The tension wheel 62, positioned below the locking lever 42, is also shown. Figure 6 As shown, the locking lever 42 is initially positioned in the locking configuration, with its proximal end protruding beyond the upper surface of the main housing 40. When the proximal end of the locking lever 42 is pressed downward into the main housing 40 by the operator, the tension wheel 62 also moves downward, thereby engaging the upper surface of the retraction belt 56 to properly tension the retraction belt 56, facilitating effective operation and rotation of the retraction belt 56 when actuated. The downward pressure on the proximal end of the locking lever 42 also disengages the finger wheel locking mechanism, allowing the finger wheel 44 to rotate, which will engage... Figures 7A to 7DA more detailed description follows. As shown, the retraction belt 56 is wound around pulley 57. To initiate the retraction of the outer sheath 12, the operator slowly rotates the finger wheel 44 (clockwise) in a proximal direction, causing the shuttle 59 and the outer sheath 12 (to which it is engaged) to linearly displace relative to the inner core assembly 13 containing the implant 2, thereby resulting in the placement of the implant 2. The inner cylinder of one of the finger wheels 44A, 44B may include teeth sized to correspond to the teeth along the retraction belt 56. As the finger wheel 44 is rotated, the operator will experience tactile feedback and hear a clear, audible click. The audible click provides the operator with a qualitative assessment of the rate (or speed) of sheath ejection, allowing the operator to adjust the rate. The right finger wheel 44A and the left finger wheel 44B are both interconnected and move together, so that the operator only needs to rotate one of them. The finger wheels 44A and 44B include gripping features (e.g., ridges and recesses) on their outer surfaces to facilitate easy rotation by the operator's thumb or fingers. The gripping features (e.g., ridges / recesses / textures) may exhibit slight directional characteristics to prompt the operator to rotate the finger wheel 44 in the correct direction (e.g., clockwise or towards the operator). In other embodiments, the finger wheel 44 may not include two separate finger wheel portions and may include a single, integral finger wheel.

[0077] The re-insertion button 47 includes teeth that engage with corresponding grooves in the re-insertion rack 60 when the re-insertion button 47 is in its default unpressed configuration. When the re-insertion button 47 is pressed inward (e.g., upward), the teeth of the re-insertion button 47 disengage from the re-insertion rack 60, thereby allowing the re-insertion rack 60 to move proximally and distally. After one or more implants have been placed, the operator can re-inserte the distal portion 4 of the catheter assembly 11 by pressing the re-insertion button 47 with one hand, which retracts the secondary sheath 46 away from the main sheath 40. This movement retracts the re-insertion rack 50 proximally (along with the re-insertion housing 46 and the proximal Luer socket 50 engaged with the inner core assembly 13). Thus, as the inner shaft 26 is pulled back (i.e., proximally), the distal portion of the inner core assembly 13 is covered (or re-inserted) by the previously pulled-back outer sheath 12.

[0078] Once the delivery device 1 has been removed from the treatment site (or completely removed from the subject's body), if implant 2 remains in the delivery device 1, the operator may choose to reinsert the delivery device 1 and advance it to another treatment site. To do this, the operator guides the delivery device 1 to the appropriate treatment site, presses the re-insertion button 47 with one hand, and pushes the re-insertion housing 46 with the other hand until the re-insertion housing 46 clicks back into place (e.g., the re-insertion housing 46 re-engages and is flush with the main housing). This operation causes the inner core assembly 13 to exit to the same location it left before being re-inserted, and standard fingerwheel operation can be resumed to place one or more remaining implants 2.

[0079] 2. Locking mechanism

[0080] Figures 7A to 7D This helps to illustrate the structural components and function of the locking mechanism of the rotary deployment handle 10. Figure 7A and Figure 7B A side view of the internal components is shown when the finger wheel 44 is in the locked configuration. The locking configuration can be the default configuration during assembly or the configuration in which the delivery device 1 is shipped to the consumer after manufacturing. The initial locking configuration advantageously prevents unintentional placement of the implant during the manufacturing process until the appropriate time when the operator wishes to place the implant on the target treatment site or location. The initial locking configuration may be referred to as a shelf-locking feature; for example, this means that the device 1 is locked when it is on a shelf before use.

[0081] like Figure 7A and Figure 7B As shown, the proximal portion of the locking lever 42 is raised above (e.g., not flush with) the upper surface of the main body housing 40 above the handle 10. The proximal end of the locking lever 42 includes a hook 72, which rests against the bottom edge of the upper surface of the main body housing 40 in the locking configuration. The locking plate 52 is biased to be pushed in the proximal direction by a torsion spring or other biasing member (not shown) that connects the left housing portion 40B to the locking plate 52. In the locking configuration, a boss or protrusion 74 provided on a triangular extension 75 extending downward from the lower edge of the proximal portion of the locking lever 42 abuts against the nearest edge of the upper portion 76 of the proximal portion of the locking plate 52, thereby preventing the locking plate 52 from moving proximally based on the bias of the torsion spring. Figure 7A The image shows the gap between the distal portion 73 of the locking plate 52 and the distal end of the re-sheathing rack 60. (See image for details.) Figure 7B As shown, when in the locked configuration / position, the proximal engagement member 77A of the locking plate 52 engages with the recess 79 between the corresponding tooth 78 of the internal gear of the finger wheel 44 to "lock" or prevent the finger wheel 44 from rotating.

[0082] Figure 7C and Figure 7D The diagram shows a side view of the internal components when the finger wheel 44 is in the unlocked configuration after the proximal portion of the locking lever 42 has been pressed down by the operator. Figure 7C As shown, in the unlocking configuration, hook 72 is positioned within the main body housing 40 as if it were in a different position than if it were in the main body housing 40. Figure 7A In a low to medium position, it is hooked into the pawl of the housing 40. When the proximal portion 42 of the locking lever 42 is pressed downward, the boss or protrusion 74 on the triangular extension 75 of the locking lever 42 no longer abuts against the nearest edge of the upper portion 76 of the proximal portion of the locking plate 52, thereby allowing the locking plate 52 to move proximally due to biasing force (e.g., torsion spring bias). Figure 7C As shown, there is no gap between the distal portion 73 of the locking plate 52 and the distal end of the re-insertion rack 60. Figure 7D As shown, since the locking plate 52 has moved proximally, the proximal engaging member 77A no longer engages with the gear teeth 78 or recess 79 of the finger wheel 44. Therefore, the finger wheel 44 rotates freely in this unlocked or neutral configuration. Figure 7D As shown, the locking plate 52 is not moved proximally enough to engage the distal engaging member 77B with the gear teeth 78 or recess 79 of the finger wheel 44. The engaging member 77 may also be referred to as the head of the locking plate 52.

[0083] 3. Ratchet and finger wheel mechanism

[0084] Go to Figure 8 and Figure 8A An embodiment of a mechanism for preventing the finger wheel 44 (and the retraction belt 56) from rotating in the opposite direction (e.g., counterclockwise) is shown and described. This mechanism advantageously prevents unintentional placement of the implant and / or damage to the implant or body tissue (e.g., blood vessel walls). Figure 8 This is a right-side view showing the internal components of the rotary deployment handle 10, with the right-side housing portion 40A removed. Figure 8A This is a close-up exploded view showing the interaction between the ratchet 54 and the finger wheel 44 of the rotary release handle 10. The outer or right side of the right finger wheel 44A includes a circular area formed by teeth 82, which engage with corresponding teeth 84 on the inner or left side of the ratchet 54. The ratchet 54 can be mounted on a boss in the right housing portion 40A (not shown) and a ratchet spring 55 (as shown). Figure 5 (As shown above).

[0085] When the finger wheel 40 rotates or rolls in a "normal" clockwise direction (i.e., towards the operator and towards the proximal end of the handle), the rotation causes the ratchet spring 55 to compress and the teeth 82 of the finger wheel to travel on the teeth 84 of the ratchet 54. This travel on the teeth 84 of the ratchet 54, with the defined movement of the finger wheel 54, produces a "ratcheting" or "clicking" sound, thus advantageously providing tactile and / or auditory feedback to the operator, and slowing the rotation to ensure more accurate results when placing implants and reducing the possibility of accidental implant placement.

[0086] When the finger wheel 44 attempts to rotate or roll in the opposite direction (i.e., away from the operator and toward the distal end of the handle), the angles of the teeth 82 of the finger wheel and the teeth 84 of the ratchet 54 are designed to prevent the finger wheel 44 from rotating in the opposite direction. According to several embodiments of this disclosure, this opposite rolling prevention feature advantageously prevents or reduces the likelihood of re-capturing a partially deployed implant, which could damage the implant or otherwise affect its proper function.

[0087] 4. Re-sheathing mechanism

[0088] Figure 9 and Figure 9A This helps to illustrate the structural components and functions of the re-sheathing mechanism of the deployment handle 10. Figure 9 yes Figure 4 The left-side view of the rotary deployment handle, with the left-side housing portion 40B removed. Figure 9AThis is a close-up view of the distal portion of the handle 10 when the resheathing function is activated. As previously described, to resheath the inner core assembly 13, the operator can press the resheathing button 47 inward and hold it in place, thereby overcoming the bias of the resheathing spring 61 and disengaging the teeth of the resheathing button 47 from the corresponding recess of the resheathing rack 60. As the resheathing button 47 is pressed, the resheathing rack 60 can be moved proximally by pulling the resheath housing 46 (also referred to as the resheathing handle) proximally (i.e., toward the operator). The resheathing button 47 can be pressed with the fingers (e.g., the thumb) of one hand while the resheath housing 46 is manually pulled back or retracted toward the operator with the other hand (e.g., with the thumb and forefinger of the other hand). The resheath housing 46 can be pulled until the operator feels a hard stop. The inner core assembly 13 (including, for example, a delivery tube 51 and an inner shaft 26) is engaged with a Luer sleeve 50 in the re-entry housing 46 (e.g., within the lumen of the flushing port 48). Therefore, retraction of the re-entry housing 46 causes the portion of the inner core assembly 13 including the inner shaft 26 (with the previously exposed implant area) (which was previously deployed out of the outer sheath 12) to be pulled back into the distal portion of the outer sheath 12, thereby re-entering the inner core assembly 13 (including the inner shaft 26). The re-entry function advantageously increases safety and reduces the likelihood of damage to body tissues or the implant when the delivery device 1 is removed from the target treatment site or from the patient's anatomy.

[0089] refer to Figure 9A During re-insertion, the proximal retraction of the re-insertion housing 46 and the re-insertion rack 60 causes the locking plate 52 to move proximally as well. Because the distal end of the re-insertion rack 60 no longer abuts against the protrusion extending from the distal portion 73 of the locking plate 52 as the re-insertion rack 60 moves proximally, the proximal bias applied by the torsion spring or other biasing member operably connected to the locking plate 52 causes the locking plate 52 to move proximally. This proximal movement of the locking plate 52 causes the distal engaging member 77B of the locking plate 52 to be received within a recess between the teeth of the gear of the finger wheel 44, effectively preventing rotation of the finger wheel 44 during re-insertion. This locking mechanism advantageously reduces the possibility of accidental implant placement during re-insertion and during subsequent dislodgement.

[0090] To redeploy any additional undeployed implant 2 remaining in the delivery device 1 (e.g., at a different target treatment site in the same patient after a clinical examination), the operator can press and hold the re-insertion button 47 again and push the re-insertion housing 46 distally (away from the operator) until the re-insertion housing 46 mates with or otherwise re-engages the proximal end of the main housing 40. Similarly, because the inner core assembly 13 is engaged to the Luer sleeve 50 within the re-insertion housing 46 (e.g., within the lumen of the fluid port 48), distal movement of the re-insertion housing 46 causes the inner core assembly 13 (including the inner shaft 26) to be re-"de-sheathed" to the same position or configuration as before "re-insertion" (e.g., the distal end relative to the outer sheath 12).

[0091] 5. Shuttle and flushing port operation

[0092] Figure 10 This is a left-side view of the rotary deployment handle 10, showing the internal components, with the left-side housing portion 40B removed. Figure 10 A shuttle 59 is shown engaging with a retractable belt 56 wound around a pulley 57. Figure 10 A side sectional view of the flushing ports 48, 49 of the proximal Luer sleeve 50 is also shown. The circled portion shows the engagement region 100, in which the internal conduit assembly 13 (including the inner shaft 26 and the delivery tube 51) is engaged within the proximal Luer sleeve 50 (e.g., within the lumen of flushing port 48 and / or flushing port 49).

[0093] Figure 10A A close-up side sectional view of each internal shuttle component is shown. The shuttle 59 houses the delivery tube 51, the engagement area 104 on the proximal end of the outer sheath 12, the outer sheath sleeve 59A, and the O-ring 59B. The delivery tube 51 protects the inner shaft 26 and forms a fluid path between the inner shaft 26 and the inner diameter of the delivery tube 51. The engagement area 104 is a designated area where the outer sheath 12 is engaged to the inside of the shuttle 59 during assembly / manufacturing. The O-ring 59B advantageously prevents or reduces the possibility of fluid backflow into the internal area of ​​the handle 10 and allows the delivery tube 51 to move within the O-ring 59B (e.g., slide, translate). The outer sheath sleeve 59A advantageously prevents or reduces the possibility of excessive movement of the O-ring 59B and prevents or reduces the possibility of excessive glue from the engagement area 104 reaching the O-ring 59B. Reference Figure 10B At the top of shuttle 59 is the retractable belt 56 which engages with and is held on shuttle 59 by shuttle clip 59C, which is fastened to the retaining wing of shuttle 59.

[0094] Figure 10CThis is a close-up side sectional view of the flushing ports 48 and 49 of the rotary deployment handle 10. As previously mentioned, the flushing ports 48 and 49 advantageously facilitate flushing of the lumens and spaces of the catheter 1 prior to use to prevent air bubbles and / or increase lubrication. For example, heparinized saline or other fluid flushing solutions can be introduced through each of the flushing ports 48 and 49. Reference Figure 10C The flushing of the fluid path in the catheter lumen (indicated by the arrows) begins with the fluid entering through the fluid flushing ports 48 and 49. As shown by the arrows, the fluid then enters between the inner shaft 26 and the delivery tube 51. Figure 10C The engagement region 107 of the delivery tube and the Luer sleeve 50 (e.g., in the lumen of the fluid port 48) is also shown. [Go to...] Figure 10D The fluid path then continues to the distal end of the actuator tube 29 (which in one embodiment includes a PEEK tube). Any fluid backflow within the shuttle 59 between the delivery tube 51 and the outer sheath 12 is channeled into a dead end using the O-ring 59B, thereby preventing or reducing the possibility of any fluid entering the handle. Figure 10D It also shows the combination Figure 10A The described joining region 104, wherein the outer sheath 12 is joined to the inside of the shuttle 59. (Reference) Figure 10E At the distal end of the actuator tube 59 (or PEEK tube), the fluid path continues to the distal end of the delivery catheter 1, and the shunt paths (one between the actuator tube 29 and the inner shaft 26, and another between the actuator tube 29 and the outer sheath 12) converge between the outer sheath 12 and the implant region (e.g., including the actuator band 27, the implant 2, and the bulge tube 28). Therefore, the delivery catheter 1 is advantageously constructed to allow fluid to flush from the fluid port all the way to the distal end of the delivery catheter 1 without creating internal leakage or significant fluid build-up or stagnant areas.

[0095] D. Example usage

[0096] Figures 11 to 15 Examples of methods of using delivery device 1 are shown. For example, implants delivered by device 1 can be used to treat various conditions, such as atherosclerotic occlusive disease. In some arrangements, the delivery device can be used to deliver one or more implants that can hold loose plaque and / or arterial tissue (dissection) to the vessel wall. In some arrangements, device 1 can be used to deliver one or more implants that can be used to treat residual stenosis in dissections or non-calcified, moderately calcified, or severely calcified lesions.

[0097] Various delivery methods and devices can be used for the placement of the implants described herein, some of which are described herein. For example, an implant according to any embodiment described herein can be delivered into a blood vessel using an intravascular insertion. Delivery catheters for different embodiments of the implant can be different or the same and can have features specifically designed for delivery of a particular implant. As mentioned above, delivery device 1 can be used to deliver a variety of different implants and is not limited to use with the specific implant shown or described herein. Figure 3 and Figure 3A It shows that it can be used with delivery device 1 and reference. Figures 11 to 15 Examples of implants used together with the methods shown and described. Figures 11 to 15 Another example of an implant is shown, which can be used with delivery device 1 and includes vertices that bend upwards or radially outwards or flip over. For simplicity, the different embodiments of the implant in the figure use the same number 2, even though the implant may not include the same features (e.g., curved vertices versus non-curved vertices).

[0098] As already mentioned, angioplasty or other types of surgery can be performed on blood vessels. Angioplasty can be performed on the diseased or blocked portion of a blood vessel. First, a cannula is inserted into the diseased blood vessel, and then a guidewire is advanced through the cannula to the desired location. In angioplasty with a balloon, the balloon catheter is advanced into the blood vessel along the guidewire and positioned at the location containing the blockage formed by plaque. The balloon can then be inflated at the desired location to compress the plaque and widen the blood vessel. The balloon can then be deflated and removed.

[0099] While widening the blood vessel, angioplasty may result in plaque dissection 114. Angiography can be performed post-angioplasty to visualize the vessel and determine if there is evidence of post-angioplasty dissection or surface irregularities. Delivery device 1 can be used to deliver an implant that can be used to secure plaque dissection 114 or other surface irregularities (e.g., remaining narrowed or stenotic portions of the vessel) to the lumen wall 117 when needed.

[0100] A delivery catheter 1, preloaded with one or more implants 2 (or other implants not shown or described herein) according to one or more embodiments described herein, can pass through a blood vessel 117 and be advanced along a guidewire to the treatment site. Figure 11In some embodiments, new or separate guidewires and cannulas may be used. With the treatment location visible, a distal marker may be positioned on the catheter assembly 11 or on the distal implant. The outer sheath 12 may be retracted to expose a portion of the implant 2. As already discussed, the outer sheath 12 may be retracted until the set point is reached, and then, if necessary, the position of the device 1 within the blood vessel may be adjusted to ensure precise placement of the implant 2. Figure 12 For example, the setting point could be exactly one of the exposed implants, part or all of the exposed ring, the exposed ring, or other markers visualized using imaging.

[0101] Implant 2 can then be released to the desired location within the blood vessel lumen. As previously discussed, simultaneous placement can be performed during the release of implant 2 in some embodiments. An additional implant 2 can then optionally be added as needed. Figure 13 The proximal or distal side is placed within the treatment segment of the blood vessel.

[0102] In some embodiments of this disclosure, precise placement of the implant 2 may begin when positioning the device 1 within the blood vessel 117, based on the location of markings on the catheter assembly 11 and / or the implant 2. Once positioned, one or more implants may then be deployed while the inner shaft 26 is held in place and the outer sheath 12 is slowly retracted.

[0103] After the placement of the second implant 2, an endovascular structure is formed in situ. In situ placement can be in any suitable vessel, such as any peripheral artery. The structure is not limited to only two implants 2. In fact, at least three, four, five, six, or more endovascular implants 2 (or any other implants described herein) can be provided in an endovascular structure formed in situ. In one embodiment, each of the plurality of implants has a length not exceeding about 14 mm. In one configuration, at least one of the implants, such as each of the implants, is spaced at least about 4 mm from an adjacent implant, or between about 4 mm and 8 mm, or between about 6 mm and 14 mm. While some embodiments of the implants have a length of 12 mm or less, other embodiments of the implants can be longer, for example, up to about 15 mm. Furthermore, adjacent implants 10 can be positioned close to or separated by 4 mm, particularly in vessels that are not easily bent or otherwise moved. In the various delivery devices / catheters described herein, the spacing between the implanted implants can be controlled to maintain a set distance or minimum distance between each implant. It can be seen that the delivery catheter and / or implants may include features that help maintain the desired distance between the implants. Maintaining proper spacing between implants helps ensure that they are distributed along the intended length and do not touch each other or cluster in specific areas of the treated blood vessel. This helps prevent kinking of the blood vessel in which they are located.

[0104] While in-situ constructions of one, two, or three implants may be suitable for certain indications, intravascular constructions with at least four, five, or six intravascular implants may be advantageous for treating loose plaques, vascular flaps, dissections, or other conditions that are significantly longer. For example, while most dissections are focal (e.g., axially short), a series of dissections may be considered and treated as a more elongated condition.

[0105] Alternatively, once the implant 2 is in place, the angioplasty balloon can be returned to the treatment site and inflated to expand the implant 2 to the desired expansion state. Figure 15 Implant 2 is shown in its final implantation state.

[0106] Delivery device 1 can be used to accurately deliver more than one intravascular implant to locations along the length of a plaque buildup site, where specific outward expansion forces are required to stabilize the site and / or to prevent dissections and / or plaque fragments from obstructing blood flow and / or to maintain the narrowing of the vessel within it. Over-stenting of the vessel can be avoided by using a series of implants. The reduction in cellular response compared to using a single stent in the same treatment area is believed to be achieved in part by reducing the surface area contact between the implant and the vessel lumen.

[0107] In several embodiments of this disclosure, one objective of the implants described herein, unlike conventional stents, is to minimize the amount of implanted foreign material while still providing focal treatment of the vascular condition, thereby minimizing vessel wall response and adverse restenosis. The implants may be designed with substantially less metal coverage and / or contact with the vessel surface, thereby causing less acute and chronic inflammation. Reduced contact area between the implanted material and the vessel wall is associated with a lower incidence of intimal hyperplasia and better long-term patency. The significantly reduced length along the axial distance of the vessel allows for more targeted treatment, associated with less foreign body coverage on the vessel surface, avoiding coverage of unwanted portions of the surface, and is associated with improved patency in both early and late stages of revascularization.

[0108] The delivery device 1 can be used to place implants only where needed to secure plaques damaged by balloon angioplasty or other mechanisms and / or multiple portions of a vessel that has undergone residual stenosis after balloon dilation, for example, in more calcified lesions. Advantageously, in several embodiments of this disclosure, the delivery device can be used to locally place more than one implant without overlap and selectively, for example, not extend into normal or less diseased arterial segments, rather than covering the entire treatment area. This allows the vessel to retain its natural flexibility, as there is minimal to no stenting when using small-profile implants locally, even when multiple implants are spaced apart along the treatment length.

[0109] While useful, embodiments of the delivery devices described herein are generally described in the context of delivering loose plaque and / or arterial tissue (dissection) against the vessel wall. Some advantages and features of the embodiments disclosed herein may be used in other applications, such as medical applications where it is desirable to deliver one or more implants to generate or maintain unobstructed blood flow in a vessel, or to address deformities or dissections in other body lumens or channels or chambers, or to address calcified lesions.

[0110] E. Conclusions and Terminology

[0111] While the apparatus described herein may be susceptible to various modifications and alternatives, specific examples of which have been shown in the accompanying drawings and described in detail herein. Furthermore, the disclosure of any particular feature, aspect, exemplary method, characteristic, feature, quality, attribute, element, etc., in conjunction with the implementation or embodiment herein may be used in all other implementations or embodiments set forth herein.

[0112] In some embodiments of this disclosure, the system or apparatus includes various features that exist as a single feature (as opposed to multiple features). For example, in one embodiment, the delivery device includes a single, integrated housing instead of multiple housing portions and / or a single, integrated finger ring instead of multiple finger ring portions. A single implant and / or a single radiopaque marking band (or other means for facilitating visualization) may also be included. Multiple features or components are provided in alternative embodiments. Furthermore, the structures described herein can be implemented as integrated components or separate components.

[0113] In some embodiments of this disclosure, the system or apparatus includes one or more of the following: means for controlling the mechanical placement of an implant (e.g., a belt / pulley assembly), various means for manually re-inserting and de-inserting the implant after initial placement (e.g., a re-insertion rack, a re-insertion button, and a re-insertion housing or handle), means for locking the operation of the placement mechanism, etc.

[0114] In the exemplary methods disclosed herein, actions or operations can be performed in any suitable order and are not necessarily limited to any specifically disclosed order, nor are they performed in the stated order. Various operations can be described as a series of discrete operations in a manner that aids in understanding certain embodiments of this disclosure; however, the order in which they are described should not be construed as implying that these operations are order-dependent. Section headings used herein are provided solely for readability purposes.

[0115] For the purpose of comparing the various embodiments of this disclosure, certain aspects and advantages of these embodiments have been described. Not all of these aspects or advantages are necessarily achieved through any particular embodiment. Thus, for example, embodiments may be implemented in a manner that achieves or optimizes one advantage or set of advantages without necessarily achieving other advantages or other sets of advantages.

[0116] Conditional language such as “may,” “can,” “may,” or “possibly,” unless explicitly stated otherwise or otherwise understood in the context as used, is generally intended to convey that certain embodiments include (while other embodiments do not) certain features, elements, and / or steps. Therefore, such conditional language is not generally intended to imply that a feature, element, and / or step is necessary in any way for one or more embodiments, or that one or more embodiments must include logic for determining whether such features, elements, and / or steps are included or will be performed in any particular embodiment, with or without user input or prompting.

[0117] Unless otherwise expressly stated, connective language such as the phrase "at least one of X, Y, and Z" is understood, along with the context, to generally convey that an item, term, etc., may be X, Y, or Z. Therefore, such connective language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z. Unless otherwise expressly stated, articles such as "a" or "an" should generally be interpreted as including one or more of the stated items.

[0118] The methods given herein for illustrative purposes may include certain actions taken by a practitioner; however, these methods may also include any third-party instructions, whether explicit or implicit, regarding these actions. For example, an action such as “deploying a self-expanding implant” includes “instructing the deployment of a self-expanding implant.” The terms “top,” “bottom,” “first,” “second,” “upper,” “lower,” “height,” “width,” “length,” “end,” “side,” “horizontal,” “vertical,” and similar terms may be used herein; it should be understood that these terms refer only to the structures shown in the accompanying drawings and are used solely to aid in the description of embodiments of this disclosure. The terms “proximal” and “distal” are opposite directional terms. For example, the distal end of a device or component is the end of the component that is furthest from the operator during normal use. Distal or end point does not necessarily mean an extreme distal end. Proximal end refers to the opposite end, or the end closest to the operator during normal use. The scope of this disclosure also covers any and all overlaps, subscopes, and combinations thereof. For example, descriptions of ranges such as 50 to 250 cm should be considered as having explicitly disclosed subranges such as 50 to 100 cm, 100 to 200 cm, 150 to 250 cm, etc., as well as individual numbers within that range, such as 50, 80, 90, 95, 100, 70.5, 90.5, and any whole or partial increments therebetween. Ranges also include numbers at range boundaries. For example, a range from 50 to 250 cm includes both 50 cm and 250 cm. Language such as “up to,” “at least,” “greater than,” “less than,” “between,” etc., includes the listed numbers. Numbers beginning with terms such as “about” or “approximately” include the listed numbers and should be interpreted on a case-by-case basis (e.g., as reasonably accurate as possible in this case, such as ±5%, ±10%, ±15%, etc.). For example, “about 4 mm” includes “4 mm.” Phrases beginning with terms such as “basically” include the listed phrases and should be interpreted on a case-by-case basis (e.g., as reasonably as possible in this case).

Claims

1. A delivery device (1) for delivering an implant (2), the delivery device comprising: The inner shaft (26) includes a proximal end and a distal end; An outer sheath (12) having a proximal end, a distal end, and a lumen extending from the proximal end of the outer sheath to the distal end of the outer sheath, the outer sheath being movable relative to the inner shaft; A rotary placement handle (10) is configured to move the outer sheath relative to the inner shaft to facilitate delivery of at least one implant carried by the inner shaft. The rotary deployment handle includes: Ring (44); A belt (56) and pulley (57) assembly, operably connected to the finger wheel and the outer sheath, such that rotation of the finger wheel causes movement of the outer sheath relative to the inner shaft; A resheathing assembly configured to facilitate manual resheathing of the inner shaft relative to the outer sheath by pulling the resheathing housing (46) connected to the inner shaft in a proximal direction; and The locking component is configured as follows: (a) Causing the finger wheel to change from a locked configuration where the finger wheel cannot rotate to an unlocked configuration where the finger wheel can rotate, and (b) Tensioning the belt during the transition from the locked configuration to the unlocked configuration; The locking assembly includes a locking lever (42) comprising a proximal end configured to extend from the main housing of the rotary deployment handle when the locking assembly is in a locked configuration, and a distal end fixedly coupled to the main housing of the rotary deployment handle; and The locking assembly further includes a locking plate (52) comprising a proximal abutment surface configured to connect with a protruding interface of the locking lever and a plurality of engaging members configured to connect with one or more recessed interfaces between the teeth of the finger wheel to prevent the finger wheel from rotating when the locking assembly is in the locking configuration, wherein the locking plate is spring-biased to move toward the proximal end of the rotary release handle.

2. The delivery device according to claim 1, wherein, The delivery device further includes a ratchet (54) comprising teeth (84) configured to operatively engage with the teeth (82) of the finger wheel, wherein the angles of the teeth of the finger wheel and the angles of the teeth of the ratchet prevent the finger wheel from rotating in a direction opposite to the normal operating direction of rotation.

3. The delivery device according to claim 1, wherein, When the operator presses the proximal end of the locking lever into the main housing, the locking assembly changes to the unlocking configuration by disengaging the protrusion of the locking lever from the proximal abutment surface of the locking plate. This causes the locking plate to move proximally, allowing the proximal engagement member of one of the plurality of engagement members of the locking plate to disengage from the finger wheel, thereby allowing the finger wheel to rotate.

4. The delivery device according to claim 1, wherein, The re-insertion assembly includes: The re-sheath housing (46) is removably attached to the proximal end of the main housing of the rotary deployment handle. A re-sheathing button (47) is configured to be adjacent to the proximal end of the main housing and located on the distal side of the re-sheathing housing; and A re-sheathing rack (60) is disposed within the main housing of the rotary deployment handle.

5. The delivery device according to claim 4, wherein, The re-sheath button is configured to prevent longitudinal movement of the re-sheath housing and the re-sheath rack unless the re-sheath button is pressed into the main housing by the operator.

6. The delivery device according to claim 5, wherein, The proximal end of the re-entry rack is fixedly connected to the re-entry housing, and the inner shaft is operably connected to the re-entry housing such that retraction of the re-entry housing in a proximal direction away from the main housing causes the re-entry rack and the inner shaft to move in a proximal direction, thereby allowing the inner shaft to re-enter the outer sheath.

7. The delivery device according to claim 6, wherein, The engagement protrusion at the distal end of the locking plate is configured to engage with the distal end of the re-sheathing rack, such that when the re-sheathing rack is in its farthest position within the main housing, the locking plate is prevented from moving proximally.

8. The delivery device according to claim 1 or 2, wherein, The delivery device also includes a plurality of flushing ports (48, 49) extending outward from the proximal end of the rotary deployment handle to facilitate flushing of the lumen of the inner shaft and the lumen of the outer sheath.

9. The delivery device according to claim 1 or 2, wherein, The inner shaft includes a lumen extending from the proximal end to the distal end.

10. The delivery device according to claim 1 or 2, wherein, The inner shaft includes a plurality of delivery platforms (8) disposed along the inner shaft toward the distal end, each of the plurality of delivery platforms including a recess extending distal to the radial protrusion.

11. A delivery device (1) for delivering an implant (2), the delivery device comprising: The inner shaft (26) includes a proximal end and a distal end; An outer sheath (12) having a proximal end, a distal end, and a lumen extending from the proximal end of the outer sheath to the distal end of the outer sheath, the outer sheath being movable relative to the inner shaft; A placement handle (10) configured to cause movement of the outer sheath relative to the inner shaft to facilitate delivery of at least one implant carried by the inner shaft, the placement handle comprising: A finger wheel (44), configured to be rotated by a user in a first rotation direction to achieve movement of the outer sheath relative to the inner shaft, thereby causing a portion of the inner shaft to extend out of the sheath; and The resheathing assembly is configured to facilitate manual resheathing of the inner shaft relative to the outer sheath by pulling the resheathing housing (46) connected to the inner shaft in a proximal direction. The re-insertion assembly includes: The re-sheath housing (46) is removably coupled to the proximal end of the main housing of the deployment handle. A re-sheathing button (47) configured to be adjacent to the proximal end of the main housing and located distal to the re-sheathing housing; and A re-sheathing rack (60) is disposed within the main housing of the deployment handle. Wherein, the proximal end of the re-entry rack is fixedly connected to the re-entry housing, and the inner shaft is operably connected to the re-entry housing, such that retraction of the re-entry housing in a proximal direction away from the main housing causes the re-entry rack and the inner shaft to move in a proximal direction, thereby allowing the inner shaft to re-enter the outer sheath; and During re-sheathing, the movement of the re-sheathing rack in the proximal direction causes the finger wheel to be placed in a locked configuration, thereby preventing the rotation of the finger wheel during re-sheathing.

12. The delivery device according to claim 11, wherein, The delivery device also includes one or more implants mounted on the inner shaft.

Images