Method of adjusting effective length of a stent and prosthetic delivery catheter assembly

Abstract

Methods of adjusting the effective length of a stent and prosthetic delivery catheter assemblies are disclosed. The methods include deploying a first portion of a stent from a stent deployment device, deploying a second portion of the stent from the stent deployment device, and shifting the stent deployment device relative to the first portion to change the effective length of the second portion.

Description

[0001] This application is a divisional application of patent application No. 201780055261.5, filed on September 28, 2017, entitled "A compliant member for receiving and assisting in the dispensing of vascular prostheses". Technical Field

[0002] This disclosure relates in its entirety to medical devices. More specifically, this disclosure relates to vascular prosthesis dispensing devices, including dispensing devices for self-deploying vascular prostheses (such as stents and stent grafts). Attached Figure Description

[0003] The embodiments disclosed herein will become more fully apparent from the accompanying drawings, the following description, and the appended claims. The drawings illustrate only typical embodiments, and these embodiments will be described with additional specificity and detail in conjunction with the drawings, in which:

[0004] Figure 1 It is a perspective view of the mixing device.

[0005] Figure 2 yes Figure 1 A cross-sectional view of a portion of the mixing device.

[0006] Figure 3A yes Figure 1 and Figure 2 A perspective view of the ratchet slider of the dispensing device.

[0007] Figure 3B yes Figure 3A A cross-sectional view of the ratchet slider.

[0008] Figure 4 yes Figure 1 and Figure 2 A side view of the carrier component of the dispensing device.

[0009] Figure 5 yes Figure 1 and Figure 2 A cross-sectional view of another part of the mixing device shown.

[0010] Figure 6 yes Figure 1 and Figure 2 A cross-sectional view of another part of the mixing device shown.

[0011] Figure 7 yes Figure 1 The front view of the dispensing device shows some of the cross-sections described herein.

[0012] Figure 8 yes Figure 1 A perspective view of the safety components of the dispensing device.

[0013] Figure 9 yes Figure 1 A side view of a portion of the delivery catheter assembly of the dispensing device.

[0014] Figure 10 yes Figure 1 A side view of another part of the delivery catheter assembly of the dispensing device.

[0015] Figure 11A This is a perspective view of another implementation of the dispensing device.

[0016] Figure 11B It was obtained along plane 11B-11B Figure 11A A cross-sectional view of a portion of the delivery catheter assembly of the dispensing device.

[0017] Figure 11C It was obtained along plane 11C-11C Figure 11A A cross-sectional view of a portion of the delivery conduit assembly of the dispensing device.

[0018] Figure 11D yes Figure 11A A side view of another part of the delivery catheter assembly of the dispensing device.

[0019] Figure 12A yes Figure 11A A side view of another part of the delivery catheter assembly of the dispensing device, wherein the prosthesis is in the first state.

[0020] Figure 12B yes Figure 12A The delivery catheter assembly is shown in a side view in the second state.

[0021] Figure 12C yes Figure 12A The delivery catheter assembly is shown in a side view in the third state.

[0022] Figure 13A This is a cross-sectional view as part of another embodiment of the delivery catheter assembly.

[0023] Figure 13B yes Figure 13A A side view of a portion of the delivery catheter assembly, with the outer sheath removed.

[0024] Figure 14 This is a perspective view of another implementation of the dispensing device.

[0025] Figure 15 yes Figure 14 A cross-sectional view of a portion of the mixing device.

[0026] Figure 16A yes Figure 14 and Figure 15A perspective view of the ratchet slider of the dispensing device.

[0027] Figure 16B yes Figure 16A A cross-sectional view of the ratchet slider.

[0028] Figure 17 yes Figure 14 and Figure 15 A side view of the carrier component of the dispensing device.

[0029] Figure 18 yes Figure 14 and Figure 15 A cross-sectional view of another part of the mixing device shown.

[0030] Figure 18A yes Figure 18 A partial cross-sectional view of a portion of the mixing device shown.

[0031] Figure 19 yes Figure 14 and Figure 15 A cross-sectional view of another part of the mixing device shown. Detailed Implementation

[0032] Dispensing devices can be configured to deliver and dispense medical devices within a patient's body. While specific examples described herein may refer to dispensing within the vascular system, similar concepts and devices can be used in a variety of other locations within the body, including placing and dispensing medical devices in: the gastrointestinal tract (including, for example, within the esophagus, intestines, stomach, small intestine, colon, and bile ducts); the respiratory system (including, for example, within the trachea, bronchi, lungs, nasal cavity, and sinuses); or any other location within the body, both within body cavities (e.g., the ureter, urethra, and / or any of the cavities discussed above) and other body structures.

[0033] Furthermore, while specific examples herein may refer to the dispensing of vascular prostheses (such as stents), the dispensing of various medical devices (including stents, stent grafts, shunts, grafts, etc.) is also within the scope of this disclosure. Additionally, the dispensing apparatus disclosed herein can be configured to deliver and dispense self-deploying medical devices, including stents configured to deploy within a body cavity during dispensing.

[0034] As used herein, delivery of a medical device generally refers to the placement of a medical device within the body, including the movement of the device along a body cavity to a treatment site. For example, delivery includes moving a coiled stent along a vascular lumen from an insertion site to a treatment site. Dispensing of a medical device refers to the placement of a medical device within the body, thereby causing the medical device to interact with the body at the treatment point. For example, dispensing includes releasing a coiled or otherwise restrained self-deploying stent from a dispensing device, thereby causing the stent to unfold and contact the lumen of the vascular system.

[0035] The dispensing devices within the scope of this disclosure can be configured to dispense medical devices progressively. Progressive dispensing can facilitate the desired placement of the medical device due to the degree of control provided to the physician during dispensing. For example, a physician may wish to dispense a portion of the stent before dispensing the remainder, to adjust placement within the vascular system, or to confirm the stent's position. Such a process can be iterative, in which the physician dispenses a portion of the stent, confirms placement, dispenses additional portions, reconfirms placement, etc., until the stent is fully dispensed.

[0036] The dispensing devices within the scope of this disclosure can be configured to provide visual, auditory, tactile, or other feedback related to the degree to which a medical device has been dispensed. Multiple types of feedback can enhance the physician's control over the procedure due to various indications regarding the position or degree of dispensing of the medical device.

[0037] Furthermore, the dispensing device within the scope of this disclosure can provide a degree of mechanical advantage during dispensing, such as by using levers to reduce the force required by the dispensing device. Therefore, the mechanical advantage can improve user comfort and level of control during use. Moreover, the dispensing device within the scope of this disclosure can be ergonomically designed to present an actuation input, configured such that a physician can directly engage and utilize the device without repositioning their hand or body. The dispensing device within the scope of this disclosure can also be configured for single-handed actuation and can be configured for two-handed use.

[0038] It should be readily understood that the components of the embodiments generally described and illustrated in the accompanying drawings can be arranged and designed in a variety of configurations. Therefore, the more detailed description of the various embodiments shown in the figures below is not intended to limit the scope of this disclosure, but merely to illustrate various embodiments. Although various aspects of the embodiments are presented in the drawings, the drawings are not necessarily drawn to scale unless explicitly indicated.

[0039] The phrases “connected to” and “linked to” refer to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interactions. Two components can be linked to each other even if they are not in direct contact. For example, two components can be linked to each other via an intermediate component.

[0040] The directional terms “proximal” and “distal” used in this article refer to their relative positions on a medical device. The proximal end of the device is defined as the end of the device that is closest to the physician when the physician is using the device. The distal end is the end of the device that is opposite to the proximal end along its longitudinal direction or the end furthest from the physician.

[0041] Similarly, although the specific implementation schemes described below may refer to the stent placement device, the concepts, devices and components discussed below can be similarly applied to the placement of a wide variety of medical devices in a wide variety of locations within the body.

[0042] Figure 1 A perspective view of the dispensing device 100 is provided. The dispensing device 100 includes a handle assembly 102 adjacent to the proximal end of the dispensing device 100. An elongated delivery catheter assembly 104 extends distally from the handle assembly 102 to a distal tip or delivery tip 174. The handle assembly 102 may provide proximal user input, wherein one or more components are configured to allow a physician to dispense or otherwise manipulate a stent disposed within the delivery catheter assembly 104.

[0043] In use, the handle assembly 102 can be positioned outside the patient's body, while the delivery catheter assembly 104 is advanced into the patient's body to a treatment location. For example, the delivery catheter assembly 104 can be advanced from an insertion site (e.g., a femoral or jugular vein insertion site) to a treatment location within the vascular system. As further detailed below, the delivery catheter assembly 104 can be configured to be advanced through bends, turns, or other structures within the anatomical structures of the vascular system. Similarly, as detailed below, a stent can be disposed within a portion of the delivery catheter assembly 104, thereby allowing a physician to dispense a stent from the distal end of the delivery catheter assembly 104 by manipulating one or more components of the handle assembly 102.

[0044] Figure 2 yes Figure 1 A cross-sectional view of a portion of the dispensing device 100. Specifically, Figure 2 yes Figure 1 A side view of a portion of the dispensing device 100, when the dispensing device 100 is as follows Figure 1 As shown in the positioning diagram, this portion is cut through a vertically extending section and intersects the longitudinal axis of the dispensing device 100. The longitudinal axis of the dispensing device 100 extends along the center of the delivery catheter assembly 104, including extending along the center of components of the delivery catheter assembly 104 that overlap with the handle assembly 102, such as the intermediate sheath 160. Figure 2 As shown.

[0045] As the handle assembly 102 is configured to be grasped or otherwise manipulated by a user and the delivery catheter assembly 104 is configured to extend along a longitudinal axis to a treatment location within the patient's body, the delivery catheter assembly 104 extends distally away from the handle assembly 102. The proximal direction is the opposite, relating to the direction defined along the longitudinal axis, extending from the distal tip 174 toward the handle assembly 102.

[0046] Figure 2 The various internal components of the handle assembly 102 are shown in cross-sectional view. A portion of the delivery catheter assembly 104 is also shown extending from the handle assembly 102. The handle assembly 102 includes a housing 110. As shown, the housing 110 surrounds certain parts of the handle assembly 102, thereby providing a gripping surface for the physician.

[0047] The housing 110 is operatively coupled to the actuator 120. The actuation of the actuator 120 relative to the housing 110 can be configured to engage a support, as further detailed below. In the illustrated embodiment, the actuator 120 is rotatably coupled to the housing 110 via a pin 112. The pin 112 extends from the housing 110 and may be integrally formed with one or more other portions of the housing 110. As shown, the pin 112 extends through a pin hole 122 in the actuator 120.

[0048] Other arrangements for operatively connecting actuator 120 and housing 110 are within the scope of this disclosure. For example, pin 112 may be integral with a portion of actuator 120 and may be received in an opening, sleeve, or bore formed in housing 110. Other types of designs for rotatable couplings (including separate connecting components, such as hinges) are also within the scope of this disclosure. Furthermore, compliant mechanisms (such as deformable flanges) may be used to rotatably connect actuator 120 and housing 110, including compliant couplings integrally formed with actuator 120, housing 110, or both. Additionally, slidably connecting an actuator (such as actuator 120) to a housing (such as housing 110) is also within the scope of this disclosure. Configurations in which actuator 120 is actuated by rotation, translation, or other displacement relative to housing 110 are within the scope of this disclosure.

[0049] Actuator 120 includes an input portion 121 extending from aperture 122. In the illustrated embodiment, the input portion 121 includes a surface that is at least partially exposed relative to housing 110. In operation, a user can manipulate actuator 120 by applying force to the input portion 121, such as... Figure 2 As indicated by the arrow marked "Input"; the input section 121 is generally oriented towards the dispensing device ( Figure 1The longitudinal axis of the actuator 120 is shifted (100 in the figure); and the actuator 120 is rotated about the pin 112 relative to the housing 110. The displacement of the actuator 120 caused by the force indicated by the arrow marked "input" corresponds to the "pressing down" of the actuator 120 or "pressing down of the actuator 120 relative to the housing 110".

[0050] The actuator 120 may also include a transmission arm 123 extending from the pin hole 122. The transmission arm 123 may be rigidly coupled to the input portion 121, including embodiments in which both the transmission arm 123 and the input portion 121 are integrally formed with the remainder of the actuator 120. The transmission arm 123 extends to a ratchet sliding engagement portion 124. As the actuator 120 rotates about the pin 112, pressure on the input portion 121 in the direction indicated by the arrow labeled "input" displaces the transmission arm 123.

[0051] Therefore, the depressurization of the input portion 121 causes displacement of the ratchet sliding engagement portion 124 relative to the housing 110. This displacement of the ratchet sliding engagement portion 124 can be understood as a rotation about the pin 112, which has a proximal translational component and a vertical translational component, because the rotation of the input portion 121 in the direction indicated by the arrow marked "input" will cause the ratchet sliding engagement portion 124 (relative to the housing 110) to be displaced both proximally and vertically.

[0052] A spring 115 may be disposed between the actuator 120 and the housing 110. The spring 115 may be configured to resist displacement of the actuator 120 in the direction indicated by the arrow marked "input," and may be configured to return the actuator to its original position after it has been pressed by the user. Figure 2 The relative positions are shown. When the handle assembly 102 is unconstrained, the spring 115 can therefore maintain (or return to) the relative position of the actuator 120 with respect to the housing 110, as shown. Figure 2 As shown.

[0053] In an exemplary embodiment, spring 115 engages with spring flange 125 of actuator 120 and spring protrusion 111 of housing 110. Spring protrusion 111 can provide a bearing surface for spring 115 offset from movable internal components of handle assembly 102, such as carrier 140, which is further detailed below. Although three spring protrusions 111 are shown in the illustrated embodiment, the use of more or fewer protrusions or other features such as ridges, flanges, shoulders, etc., is also within the scope of this disclosure.

[0054] The illustrated embodiment includes a leaf spring 115. Other biasing elements such as coil springs, piston assemblies, compliant mechanisms, etc., are also within the scope of this disclosure. In some cases, the compliant portions of one or both of the housing 110 and the actuator 120 can provide a biasing force similar to that provided by the spring 115. A leaf spring, such as spring 115, can be configured to provide a relatively constant biasing force as the actuator 120 is rotated or compressed relative to the housing 110, even though the spring 115 is under pressure.

[0055] As the actuator 120 is pressed down relative to the housing 110, the spring 115 is compressed and the ratchet sliding engagement portion 124 is displaced as described above. Similarly, the displacement of the ratchet sliding engagement portion 124 relative to the housing 110 can be understood as having a proximal component and a vertical component.

[0056] The ratchet sliding engagement portion 124 is operably coupled to the ratchet slider 130, such that displacement of the ratchet sliding engagement portion 124 also displaces the ratchet slider 130. The ratchet slider 130 can be constrained such that it is configured to displace only proximally or distally relative to the housing 110. Therefore, the operable coupling of the ratchet sliding engagement portion 124 to the ratchet slider 130 allows for sliding interaction between the ratchet sliding engagement portion 124 and the ratchet slider 130, such that only the proximal or distal component of the displacement of the ratchet sliding engagement portion 124 is transmitted to the ratchet slider 130. In other words, the ratchet slider 130 can be displaced in a direction parallel to the longitudinal axis of the dispensing device 100, while the input displacement can be at an angle to the longitudinal axis of the dispensing device 100. It should be noted that in Figure 2 In the configuration shown, safety member 180 prevents proximal displacement of ratchet slider 130. Safety member 180, including its removal, is discussed in more detail below. Therefore, the discussion herein regarding the displacement of ratchet slider 130 and related components should be understood as disclosure relating to the configuration of handle assembly 102, in which safety member 180 has been removed.

[0057] As the actuator 120 is pressed down relative to the housing 110, the ratchet slider 130 can thus be displaced proximally relative to the housing 110. One or both of the ratchet slider 130 and the actuator 120 may also interact with the housing 110, thereby creating a positive stop to prevent the pressing down of the actuator 120 and / or the proximal displacement of the ratchet slider 130. This positive stop may be an engagement flange, shoulder, lug, pawl, or other feature coupled to the housing 110, including features integrally formed on the housing 110.

[0058] Therefore, the full stroke of actuator 120 can correspond to the stroke from... Figure 2The unconstrained position shown is the displacement to positive stop caused by the interaction with the housing 110 when the actuator 120 is pressed down. Then, releasing the actuator 120 after full or partial stroke can cause the actuator 120 to return to the unconstrained state due to the biasing force provided by the spring 115. Figure 2 The unconstrained state shown refers to the lack of constraint due to user input. In this state, spring 115 can be partially compressed, and the interaction between actuator 120 and housing 110 prevents actuator 120 from rotating about pin 112 in the direction opposite to the compression of actuator 120 or in the return direction. In other words, the interaction between actuator 120 and housing 110 (or a feature of housing 110) can also produce a positive stop on the return motion of actuator 120.

[0059] refer to Figure 1 and Figure 2 Both actuator 120 and housing 110 can be coupled such that compression of external materials (such as a physician's hand or surgical drapes) is minimized when actuator 120 is depressed or retracted. For example, actuator 120 may include housing configured to engage with and slide into housing 110. Although the components may slide and rotate relative to each other, the interfaces of the components may be tight and / or smooth enough to minimize compression or other engagement of external materials. Such tight and / or smooth interfaces may refer to interactions at the edges of the actuator as actuator 120 moves into housing 110 and / or interactions at the portion of actuator 120 near pin 112 as actuator 120 returns to an unconstrained position.

[0060] Other examples Figure 1 and Figure 2 As shown, the input portion 121 of the actuator 120 may also include a ridge or other features to facilitate operation or gripping of the actuator 120 during use.

[0061] Refer again Figure 2 The ratchet slider 130 can therefore be displaced proximally during the depressoring of the actuator 120. Similarly, such displacement can correspond to a configuration in which... Figure 2 The safety member 180 shown has been removed. Due to the interaction between one or more carrier engaging ratchet lugs 136 on the ratchet slider 130 and the ratchet sliding engagement arm 146 connected to the carrier 140, the proximal displacement of the ratchet slider 130 can also cause the carrier 140 to shift proximally.

[0062] Figure 3A yes Figure 1 and Figure 2 A perspective view of the ratchet slider 130 of the dispensing device 100. Figure 3BIt is cut by a vertical plane set along the longitudinal centerline of the ratchet slider 130. Figure 3A A cross-sectional view of the ratchet slider 130. When the ratchet slider 130 is set... Figure 2 When the handle assembly 102 is inside the tumbler assembly, the cross section should intersect with the longitudinal axis of the dispensing device 100.

[0063] like Figure 2 , Figure 3A and Figure 3B As shown, the ratchet slider 130 may include a plurality of carrier-engaging ratchet lugs 136. The carrier-engaging ratchet lugs 136 may be spaced evenly apart along the longitudinal direction of the ratchet slider 130. In the drawings, exemplary carrier-engaging ratchet lugs are indicated by reference numeral 136, while the farthest carrier-engaging ratchet lug located at the distal end of the ratchet slider 130 is indicated by reference numeral 136a.

[0064] The ratchet slider 130 also includes a ratchet sliding safety opening 139 and an actuator engagement opening 134. These features will be discussed in more detail below.

[0065] As described above, the interaction between the ratchet sliding engagement portion 124 of the actuator 120 and the ratchet slider 130 allows the ratchet slider 130 to be displaced proximally relative to the housing 110. As the ratchet slider 130 displaces proximally relative to the housing 110, engagement between the carrier 140 and one of the carrier-engaging ratchet lugs 136 also allows the carrier 140 to displace proximally. Figure 2 In the configuration, the ratchet sliding engagement arm 146 of the carrier 140 engages with the farthest carrier engagement ratchet lug 136a.

[0066] Figure 4 yes Figure 1 and Figure 2 A side view of the carrier 140 of the dispensing device 100. (See attached image.) Figure 4 As shown, the ratchet sliding engagement arm 146 extends radially away from the longitudinal axis of the carrier 140. When the carrier 140 is positioned... Figure 2 When the carrier 140 is inside the handle assembly 102, the longitudinal axis of the carrier 140 is set along the longitudinal axis of the dispensing device 100.

[0067] Figure 5 yes Figure 1 and Figure 2 A cross-sectional view of a portion of the dispensing device 100 shown. Specifically, the actuator 120, ratchet slider 130, and carrier 140 are... Figure 5 The text is a mix of Chinese characters and symbols, making it difficult to translate accurately. It appears to be a collection of fragments related to various topics, including online gaming, and possibly even phonetic expressions. Figure 2 They are in the same relative position and along the same cross section.

[0068] See Figures 2 to 5During the compression of actuator 120 relative to housing 110, actuator 120 rotates about pin hole 122. This rotation causes displacement of ratchet sliding engagement portion 124 of actuator 120. Due to the interaction between ratchet sliding engagement portion 124 of actuator 120 and actuator engagement opening 134 of ratchet slider 130, the component of this displacement associated with the proximal displacement of ratchet sliding engagement portion 124 also causes ratchet slider 130 to translate proximally. In other words, the wall or surface defining actuator engagement opening 134 can contact ratchet sliding engagement portion 124, thereby causing ratchet slider 130 to shift when actuator 120 shifts.

[0069] Due to the interaction between the carrier engaging ratchet lug 136 and the ratchet sliding engagement arm 146, the proximal displacement of the ratchet slider 130 also causes the carrier 140 to shift proximally. In the illustrated embodiment, the distal surface of the ratchet sliding engagement arm 146 contacts the proximal surface of the farthest carrier engaging ratchet lug 136a. This contact applies a proximal force on the distal surface of the ratchet sliding engagement arm 146, thereby displacing the carrier 140 in a proximal direction. Therefore, the ratchet slider 130 and the carrier 140 will move proximally until the actuator 120 reaches the end of its stroke.

[0070] Figure 6 The outer shell 110 and the carrier 140 are in Figure 2 The sectional views shown are at the same relative positions. Figure 6 The cross-section extends along the longitudinal axis of the mixing device; however, Figure 6 The cross section is orthogonal to Figure 2 , Figure 3B and Figure 5 The cross-section extends horizontally.

[0071] like Figure 6 As shown, the carrier 140 includes a housing engagement arm 148 extending radially away from the longitudinal axis of the carrier 140. The housing 110 includes a plurality of carrier engagement housing lugs 118. Figure 6 In the figure, an exemplary carrier engagement housing lug is indicated by reference numeral 118, wherein the farthest carrier engagement housing lug is indicated by reference numeral 118a.

[0072] See Figures 2 to 6 As the interaction between the actuator 120, the ratchet slider 130, and the carrier 140 causes the carrier 140 to shift relative to the housing 110 (as shown and described above), the housing engagement arm 148 of the carrier 140 (as...) Figure 6 (As shown) will deflect radially inward due to contact with one of the lugs 118 of the carrier engagement housing. For example, from Figure 6Starting at the indicated position, as the interaction between the farthest carrier engagement ratchet lug 136a and the ratchet sliding engagement arm 146 of the carrier 140 pulls the carrier 140 proximally, the farthest carrier engagement housing lug 118a causes the housing engagement arm 148 to shift radially inward. The housing engagement arm 148 will continue to deflect radially inward until the distal end of the housing engagement arm 148 is positioned proximally to the farthest carrier engagement housing lug 118a, at which point the housing engagement arm 148 will return to its original position. Figure 6 The radially outward configuration is shown. The point on the proximal side of the outer housing engagement arm 148 moving to the farthest carrier engagement housing lug 118a can correspond to the stroke of the actuator 120, thereby causing engagement to occur at the end of the stroke between the outer housing engagement arm 148 and the next carrier engagement housing lug 118 (moving in the proximal direction), which can correspond to the contact between the ratchet slider 130 and / or the actuator 120 and the positive stop on the housing 110 defining the end of the stroke.

[0073] As the actuator 120 is released after its stroke, the interaction between the spring 115, the housing 110, and the actuator 120 will cause the actuator 120 to return to the unconstrained position as described above. Figure 2 (as shown in the diagram). Therefore, the corresponding rotation of actuator 120 about pin hole 122 will be associated with the displacement of ratchet sliding engagement portion 124, including a displacement component in the distal direction. Then, the interaction between ratchet sliding engagement portion 124 and actuator engagement opening 134 will be associated with the distal displacement of ratchet slider 130. Therefore, when actuator 120 is released at the end of its stroke, actuator 120, spring 115 and ratchet slider 130 return to the same position relative to the housing, as shown in the diagram. Figure 2 As shown.

[0074] However, when the actuator 120 returns to the unconstrained position, the interaction between the housing engagement arm 148 and the carrier engagement housing lug 118 prevents distal displacement of the carrier 140. Specifically, the distal surface of the housing engagement arm 148 contacts the proximal surface of the carrier engagement housing lug 118, and this interaction prevents the carrier 140 from returning to the pre-stroke position. In the exemplary stroke discussed above, the distal carrier engagement housing lug 118a displaces the housing engagement arm 148 during the stroke, and the housing engagement arm 148 engages with the distal carrier engagement housing lug 118a after the stroke. Subsequent strokes cause the carrier 140 to move in the proximal direction along the plurality of carrier engagement housing lugs 118.

[0075] As the actuator 120 returns to the unconstrained state, the radial inward displacement of the ratchet sliding engagement arm 146 of the carrier 140 allows the ratchet slider 130 to move distally relative to the carrier 140, since the engagement between the carrier 140 and the carrier engagement housing lug 118 prevents distal displacement of the carrier 140.

[0076] See Figures 2 to 6 For details, please refer to Figure 5 In the view, the distal displacement of the ratchet slider 130 relative to the carrier 140 creates an interaction between the carrier engaging ratchet lug 136 and the ratchet sliding engagement arm 146, resulting in a radially inward displacement of the ratchet sliding engagement arm 146. The proximal-facing surfaces of the carrier engaging ratchet lug 136 can be angled to facilitate this interaction. In the exemplary stroke discussed above, engagement between the distal carrier engaging ratchet lugs 136a causes the carrier 140 to shift in the proximal direction; during the return of the actuator 120, the next carrier engaging ratchet lug 136 (in the proximal direction) causes a radially inward displacement of the ratchet sliding engagement arm 146 until the ratchet sliding engagement arm 146 is proximal to the carrier engaging ratchet lug 136. At this point, the ratchet sliding engagement arm 146 returns to a radially outward position (with...). Figure 5 (Similar to the position shown), but the distal surface of the ratchet sliding engagement arm 146 now engages with the proximal side of the next carrier engagement ratchet lug 136 (again in the proximal direction). The displacement of the ratchet slider 130 sufficient to engage with the subsequent carrier engagement ratchet lug 136 corresponds to the magnitude of the ratchet slider 130 displacement, which corresponds to the return of the actuator 120. The subsequent return of the actuator 120 after its stroke causes the ratchet slider 130 to move, thereby allowing multiple carrier engagement ratchet lugs 136 to engage with the carrier 140 in series after the stroke.

[0077] Therefore, as described above, pressing the actuator 120 to its full stroke and then allowing it to return to an unconstrained position causes the carrier 140 to shift relative to the housing 110 in discrete increments, corresponding to the longitudinal distance between adjacent carrier-engaging housing lugs 118. With this progressive shift of the carrier 140, the interaction of the actuator 120 and the positive stops associated with the housing 110, carrier arms (e.g., ratchet sliding engagement arm 146 and housing engagement arm 148), and lugs (e.g., carrier-engaging housing lugs 118 and carrier-engaging ratchet lugs 136) can also be combined to provide tactile and auditory feedback to the user. Furthermore, one or more openings in the housing 110 allow the user to observe the relative position of the carrier 140, thus providing further feedback regarding the position of the carrier 140.

[0078] As detailed below, the relative position of the carrier 140 with respect to the housing 110 can be related to the degree of stent placement from the dispensing device 100. Therefore, during use of the dispensing device 100, visual, auditory, and tactile feedback regarding the position of the carrier 140 provides the user with information about stent placement. This information can be associated with increased control during placement, as the physician can quickly and intuitively infer the degree of stent placement.

[0079] As described above, tactile and / or auditory feedback is generated by the interaction of the carrier 140, the ratchet slider 130, the housing 110, and / or the actuator 120. For example, an auditory and / or tactile response may be present as the ratchet slider engagement arm 146 of the carrier 140 or the housing engagement arm 148 deflects radially inward and then returns outward.

[0080] The device can be configured to provide visual feedback or be associated with the relative placement of the stent. For example, in some embodiments, housing 110 may include an observation window to allow a physician to observe the position of carrier 140 relative to housing 110. Additionally, markings on housing 110 may correlate the position of carrier 140 with the degree of stent placement.

[0081] The displacement increments of the carrier 140 can be related to standard support lengths or units of measurement. For example, many support dimensions are set in 1cm increments. Therefore, the configuration of displacement increments on the carrier 140 (increments of 1cm) should be directly related to the support length in a 1:1 ratio. Any other ratio (including embodiments in which the stroke is related to a larger length (such as 2cm, 3cm, 4cm, or 5cm) or a smaller length (such as 0.01cm, 0.1cm, 0.25cm, 0.5cm, or 0.75cm)) is also within the scope of this disclosure.

[0082] In some embodiments, the interaction between the carrier 140, ratchet slider 130, housing 110, and / or actuator 120 may include additional carrier-engaging ratchet lugs 136 and / or carrier-engaging housing lugs 118. For example, the carrier-engaging ratchet lugs 136 may be spaced apart such that the ratchet slider 130 can be semi-continuously ratcheted relative to the actuator 120 and / or housing 110. (Refer to below) Figures 14 to 19 The dispensing device 400 shown in the diagram further describes such an implementation in detail.

[0083] The dispensing device 100 can be configured as a universal device that can operate on various stent lengths. In some embodiments, the physician can directly equate the number of strokes required to dispense the stent to the length of the stent loaded in the dispensing device 100 (e.g., four strokes for a 4 cm stent). Furthermore, a single design of the dispensing device 100 can be used with stents of different lengths, the maximum length of which is related to the maximum stroke length of the carrier 140.

[0084] The depressing nature of actuator 120 facilitates single-handed operation and is ergonomically designed. Firstly, the physician only needs one hand to grasp the dispensing device to depress the actuator, leaving the second hand free for other treatment needs. Furthermore, the direction in which the dispensing device is grasped (whereby the physician's hand extends laterally away from the longitudinal axis of the dispensing device and in a depressing lateral direction, which is, for example, opposite to a longitudinal grasp for actuation) can be ergonomic. Lateral grasping and input make it easier to present the dispensing device 100 when the delivery catheter assembly 104 is positioned within the patient, without requiring the physician to move into an awkward position relative to other treatment tools. Moreover, compared to finger triggers or similar actuation mechanisms, the input portion 121 of actuator 120 provides the physician with additional surfaces for grasping, thereby facilitating actuation using a larger portion of the physician's hand.

[0085] The progressive displacement of the carrier 140 can further facilitate partial stent deployment, thereby allowing physicians to deploy the stent in an incremental manner, which may allow for adjustment or confirmation of the stent's position between these increments.

[0086] Furthermore, the dispensing device 100 can be configured for use with the right or left hand, or for gripping and contacting the actuator 120 with fingers or palm without altering the design of the dispensing device 100. These features can further enhance user comfort and control. An observation window in the housing 110 for confirming position on the carrier 140 can be located on one or both sides of the housing 110 and can be associated with markings related to support length or other factors.

[0087] Furthermore, the relative lengths of the input portion 121 and the transmission arm 123 of the actuator 120 can be configured to provide a mechanical advantage when adjusting the support. This improves comfort and controllability during use. The ratio of the length of the input portion 121 (from its distal end to the pin hole 122) to the length of the transmission arm 123 (from the pin hole 122 to the ratchet sliding engagement portion 124) can be greater than or equal to 1.5:1, including 2:1, 2.5:1, 3:1, 3.5:1, or greater. This ratio relates to the mechanical advantage provided by the device. In some cases, the provided mechanical advantage can be 1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, or greater. In other words, the ratio of the travel length of the input portion 121 to the corresponding travel length of the ratchet sliding engagement portion 124 can be 1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, or greater. Therefore, the input force applied by the abutment input portion 121 can cause the ratchet sliding engagement portion 124 to apply a greater force on the ratchet slider 130. The ratio of the force applied to the ratchet slider 130 to the input force can be 1.5:1, 2:1, 2.5:1, 3:1, 3.5:1 or greater.

[0088] Figure 7 This is a front view of the mixing device 100, showing two cross-sections. Specifically, plane AA extends perpendicularly along the longitudinal axis of the mixing device 100, showing the exposed components viewed from right to left. Plane AA corresponds to... Figure 2 , Figure 3B and Figure 5 The cross-section. Plane BB also extends from the longitudinal axis of the dispensing device 100, although plane BB extends horizontally from it. Plane BB corresponds to Figure 6 The cross-section is viewed from top to bottom. The longitudinal axis of the dispensing device 100 lies in both planes AA and BB, where the line is defined as the intersection between these planes, which is the same as the longitudinal axis described herein.

[0089] Additionally, as described above, the dispensing device 100 may include a safety component 180. Figure 8 This is a perspective view of the safety member 180 of the dispensing device 100. The safety member 180 may be configured to have a circular or partially circular opening that is configured to engage with a portion of the outer surface of the dispensing device 100. (Reference) Figure 2 and Figure 8 Both, the safety member 180 may include a safety lug 189 extending through the ratchet sliding safety opening ( Figure 3A The safety lug 189 (not shown) and similar safety openings in the housing 110. When the safety lug 189 is positioned within these openings, it prevents proximal displacement of the carrier 140 and ratchet slider 130, thereby preventing unintentional stent dispensing. The safety member 180 can remain in place during the repositioning of the delivery catheter assembly 104 to the treatment area. Due to the interaction between the carrier 140, ratchet slider 130, and actuator 120, the safety member 180 also prevents displacement of the actuator 120 as the safety lug 189 extends through the openings.

[0090] In the illustrated embodiment, the safety lug 189 extends through the bottom of the housing 110 and the ratchet slider 130. In other embodiments, the safety lug 189 may extend through the top surface of the housing 110, interacting with the carrier 140 but not directly with the ratchet slider 130. However, preventing only proximal displacement on the carrier 140 will also prevent displacement of the ratchet slider 130 and the actuator 120 due to the interaction between these elements.

[0091] In some embodiments, the safety member 180 may be fastened to the dispensing device 100, or may include a slide switch or other element operatively coupled to the housing 110 or other components of the dispensing device 100. In the illustrated embodiment, the safety member 180 is removably coupled.

[0092] Figure 9 This is a side view of a portion of the delivery catheter assembly 104 of the dispensing device 100. Specifically, Figure 9 This is a side view of the distal segment of the delivery catheter assembly 104. Figure 10 It is the delivery catheter assembly 104 with Figure 9 A side view of a similar longitudinal segment is shown; however, the outer sheath has been removed. Figure 9 (150) to show other components.

[0093] See Figure 1 , Figure 2 , Figure 9 and Figure 10 The delivery catheter assembly 104 may be configured to dispense a support upon actuation of the dispensing device 100, as described above. The delivery catheter assembly 104 may include an outer sheath 102 extending from the handle assembly 150. The outer sheath 150 may be fixedly coupled to the carrier 140. The delivery catheter assembly 104 may also include an intermediate sheath 160 and an inner sheath 170, both disposed within the outer sheath 150 and both fixedly coupled to the housing 110. Therefore, proximal displacement of the carrier 140 relative to the housing 110 will cause proximal displacement of the outer sheath 150 relative to both the intermediate sheath 160 and the inner sheath 170.

[0094] The outer sheath 150 may include a shaft segment 156 extending distally from the carrier 140. At the distal end of the shaft segment 156, the outer sheath 150 may include a flexible region 154 extending distally from the shaft segment 156. Finally, the outer sheath 150 may include a strip-shaped compartment 152 extending distally from the flexible region 154. (e.g.) Figure 9 As shown, the strip-shaped compartment 152 can be transparent.

[0095] The shaft segment 156 of the outer sheath 150 may have a different stiffness and / or rigidity than the flexible zone 154 and / or the strip chamber 152. Flexibility toward the distal end of the outer sheath 150 can improve the trackability of the delivery catheter assembly 104 on the guidewire and can reduce trauma, while a stiffer shaft can be more resistant to kinking and / or transmit displacement and / or torque along the shaft segment 156.

[0096] The strip compartment 152 may be configured to hold a coiled or otherwise constrained support. Removing the strip compartment 152 from the support allows the support to self-unfold for deployment. The following are within the scope of this disclosure: the strip compartment 152 has any relative length; the flexible section 154 has any relative length; and the shaft segment 156 has any relative length. Therefore, in some cases, the constrained support may be located in one, two, or all three of these portions of the outer sheath 150. For example, in an exemplary embodiment, the annular space 176 (further described below) is configured to receive a portion of the coiled support extending along the strip compartment 152, as well as the flexible section 154 and the shaft segment 156. In other embodiments, the annular space 176 may be associated only with a segment of the strip compartment 152, meaning the device is configured to hold the coiled support only within that segment of the strip compartment 152.

[0097] The distal tip 174 of the delivery catheter assembly 104 may be coupled to and / or integrally formed with the inner sheath 170. The lumen 172 may extend along the inner sheath 170 from the proximal end of the dispensing device 100 to the distal tip 174. A Luer connector 113 coupled to the housing 110 may communicate with the lumen 172. Therefore, a guidewire may extend through the Luer connector 113, through the lumen 172, and beyond the distal tip 174. Furthermore, fluid introduced into the Luer connector 113 may be used to flush the lumen 172.

[0098] The inner sheath 170 may be secured to the outer casing, for example, at its proximal end. An intermediate sheath 160, also secured to the outer casing 110, may extend over a portion of the inner sheath 170. The intermediate sheath 160 and the inner sheath 170 may or may not be directly secured to each other. In some embodiments, the intermediate sheath 160 may slide snugly onto the inner sheath 170.

[0099] The inner sheath 170 may extend distally beyond the distal end of the intermediate sheath 160, creating an annular space 176 between the inner sheath 170 and the outer sheath 150 near the distal tip 174, thereby extending proximally to the distal end of the intermediate sheath 160. This annular space 176 may be configured to retain the curled support.

[0100] As the dispensing device 100 is manipulated to progressively displace the carrier 140 relative to the housing 110, the outer sheath 150 progressively displaces proximally relative to the inner sheath 170 and the intermediate sheath 160. The distal end of the intermediate sheath 160 interacts with the proximal end of the stent, thereby preventing the stent from being pulled back together with the outer sheath 150. Thus, the stent is progressively exposed and allowed to self-deploy and dispense.

[0101] In some embodiments, a fluid orifice 162 in the intermediate sheath 160 may extend through the walls of the intermediate sheath 160 and the inner sheath 170, forming fluid communication with the inner cavity 172. Therefore, the fluid orifice 162 can provide fluid communication between the annular space 176 and the inner cavity 172, as fluid within the inner cavity 172 can move through the fluid orifice 162 and into the annular space 176. This communication can be used to flush the annular space 176 during use, and it may be configured to remove air or other unwanted material from the annular space 176 or around the coiled support.

[0102] The distal tip 174 may include a flexible material and can be configured to be non-invasive. The distal tip 174 may include nylon, including Polyether block amide.

[0103] In some cases, braided or coiled reinforcements may be added to the outer sheath 150, the intermediate sheath 160, and / or the inner sheath 170 to increase resistance to kinking and / or elongation. The reinforcements may include stainless steel, nitinol, or other materials, and their cross-section may be circular, flat, rectangular, etc.

[0104] One, two, or all of the outer sheath 150, intermediate sheath 160, and / or inner sheath 170 may be configured to have varying hardness or other properties along their length. In some cases, the outer sheath 150 may be configured to have a proximal segment with a hardness between 72 and 100 on the Shore A scale, or greater than 100 on the Shore A scale. The hardness of the second portion of the outer sheath 150 may be 63 on the Shore D scale, and the hardness of the distal segment may be between 40 and 55 on the Shore D scale. Limitations of any one or any range of these values ​​may vary by 15 units in either direction. In some cases, the second portion may begin approximately six inches from the distal end of the outer sheath 150, and the distal end may begin approximately three inches from the distal end of the outer sheath 150. These segments may or may not correspond to the shaft segment 156, flexural zone 154, and strip chamber 152 as described above. The intermediate sheath 160 can be configured to have a hardness zone that varies within the same hardness and length range.

[0105] Any of the inner sheath 170, intermediate sheath 160, and outer sheath 150 may have different hardness or flexural regions along their length, and these regions may overlap in various ways to create a variety of stress / strain distributions throughout the delivery conduit assembly 104. Such overlap of regions can reduce the tendency for kinking, including the tendency for kinking at transition areas. Additionally, the outer shell 110 may be coupled to the strain relief member 116 (e.g., Figure 2 (As shown).

[0106] Any one of the outer sheath 150, the intermediate sheath 160, and the inner sheath 170 may be made of nylon, including Polyether block amides. Furthermore, during manufacturing, any of these components can be configured to have a low-friction outer surface by methods including “frosting” the material, blowing air across the material during extrusion, or by using additives during extrusion to reduce friction.

[0107] In some cases, during manufacturing, the distal tip 174 can be pulled to interfere with the outer sheath 150, thereby applying prestress to the inner sheath 170 under stress. This reduces any effects of material creep or elongation during sterilization, thus maintaining a tight nesting between the distal tip 174 and the outer sheath 150. Additionally, during manufacturing, the interface region between the outer sheath 150 and the carrier 140 can be configured with a tolerance zone, meaning the outer sheath 150 can be coupled to the carrier 140 at multiple points along the inner diameter of the carrier 140. This tolerance allows for the absorption of manufacturing variations or changes during assembly to ensure a tight nesting between the distal tip 174 and the outer sheath 150. The same tolerance fit can be applied to the inner sheath 170 and / or the intermediate sheath 160, where these components are coupled to the housing 110, including a mating area along the inner diameter of the Luer joint 113.

[0108] In some cases, the outer sheath 150 may include markings related to the degree to which the support has been fitted. These markings may correspond to the position of the outer sheath 150 relative to the housing 110. For example, as the outer sheath 150 is pulled into the housing 110, different markings are exposed and / or covered.

[0109] Additionally, in some cases, the dispensing device 100 may be configured such that the outer sheath 150 can be displaced distally after the stent is dispensed, so that the distal tip 174 is nested in the outer sheath 150 during withdrawal of the dispensing device 100 from the patient. Such configurations may include features of the handle assembly 102 that disengage the carrier 140 from one or more elements after stent dispensing.

[0110] Figures 11A to 11D An embodiment of a dispensing device 200, which is similar in some respects to the dispensing device 100 described above, is shown. Therefore, similar features are designated with similar reference numerals, wherein the first digit is increased to "2". For example, Figures 11A to 11D The illustrated embodiment includes a distal tip 274, which may in some respects be similar to... Figure 1 , Figure 9 and Figure 10 The distal apex 174. Therefore, the aforementioned disclosure regarding the features of similar markings may not be repeated below. Furthermore, Figures 1 to 10Specific features of the dispensing device 200 and related components shown may not be indicated or labeled in the accompanying drawings or discussed in detail in the following written description. However, such features may be clearly identical or substantially identical to features shown and / or described with respect to such embodiments. Therefore, the description of such features also applies. Figures 11A to 11D Feature parts of the dispensing device 200 and related components shown. Regarding... Figures 1 to 10 Any suitable combination and variation of the features described in the illustrated dispensing device 100 and related components can be used Figures 11A to 11D The dispensing device 200 and related components, and vice versa. This form of disclosure also applies to other embodiments shown in the subsequent figures and described below, where the first digit may be further increased.

[0111] Figure 11A This is a perspective view of the dispensing device 200. The dispensing device 200 includes a handle assembly 200 adjacent to the proximal end of the dispensing device 202. An elongated delivery catheter assembly 204 extends distally from the handle assembly 202 to a distal tip 274. The handle assembly 202 can provide proximal user input, wherein one or more components are configured to allow a physician to dispense or otherwise manipulate a prosthesis disposed within the delivery catheter assembly 204. As noted above, although specific examples herein may refer to prostheses such as stents, other prostheses are also within the scope of this disclosure, including but not limited to vascular prostheses, stents, stent grafts, shunts, grafts, etc.

[0112] Figure 11B It was obtained along plane 11B-11B Figure 11A A cross-sectional view of a portion of the delivery catheter assembly 204 of the dispensing device 200. Specifically, Figure 11B This is a cross-sectional view of the distal portion of the delivery catheter assembly 204. Figure 11C It was obtained along plane 11C-11C Figure 11A A cross-sectional view of a portion of the delivery catheter assembly 204 of the dispensing device 200. Figure 11D It is the delivery catheter assembly 204 with Figure 11B A side view of a similar longitudinal segment is shown; however, the outer sheath has been removed. Figure 11B (250) to show other components.

[0113] See Figures 11B to 11DThe delivery catheter assembly 204 may include an outer sheath 250. The delivery catheter assembly 204 may also include an intermediate sheath 260 and an inner sheath 270, each of which may be disposed within the outer sheath 250. Additionally, the inner sheath 270 may be disposed within the intermediate sheath 260. In some embodiments, the delivery catheter assembly 204 may not include the intermediate sheath 260. In some embodiments, the outer sheath 250 may be displaced relative to each of the intermediate sheath 260 and the inner sheath 270.

[0114] An annular space 276 may be disposed between each of the outer sheath 250 and the inner sheath 270. In some embodiments, the annular space 276, or a portion thereof, may be configured to receive / or retain a coiled or otherwise constrained support. Removing or displacing the outer sheath 250 from around the constrained support allows the support to self-unfold for deployment. Within the scope of this disclosure, the annular space 276 has any relative length. Thus, in some cases, the constrained support may be disposed along only a portion of the length of the annular space 276. In some other cases, the constrained support may be disposed along substantially the entire length of the annular space 276.

[0115] In various embodiments, the intermediate sheath 260 may be directly connected to the inner sheath 270. In various other embodiments, the intermediate sheath 260 may not be directly connected to the inner sheath 270. For example, the intermediate sheath 260 may be tightly slidably fitted onto the inner sheath 270.

[0116] As shown, the inner sheath 270 may extend distally beyond the distal end of the intermediate sheath 260, thereby creating or forming an annular space 276 between the inner sheath 270 and the outer sheath 250 near the distal tip 274. Furthermore, the annular space 276 may extend proximally from near the distal tip 274 to near the distal end of the intermediate sheath 260. The annular space 276 may be configured to maintain a coiled or constrained support.

[0117] The compliant member 290 may be disposed partially around or around the inner sheath 270. As shown, the compliant member 290 may be disposed around the circumference of the inner sheath 270. For example, the compliant member 290 may be coupled to a portion of the outer surface of the inner sheath 270. The compliant member 290 may also be disposed within a portion of the annular space 276. In some embodiments, the compliant member 290 may be configured to engage and / or retain a support or a restrained support. In other words, the compliant member 290 may at least partially grip, anchor, retain, and / or hold a support or a restrained support. In some embodiments, a support may be disposed around the compliant member 290, and then the support may be restrained, coiled, and / or loaded around the compliant member 290. Furthermore, a portion of the loaded support (e.g., the inner surface of the loaded support) may be imprinted within a portion of the compliant member 290 (e.g., the outer surface of the compliant member 290), as discussed in further detail below.

[0118] In some embodiments, the compliant member 290 may include two or more layers. In some embodiments, the compliant member 290 may include two or more materials. Each of the materials may have different or various properties, such as variations in thickness, stiffness, elasticity, etc. In some embodiments, the compliant member 290 may include an inner layer configured to adhere to or be coupled to the inner sheath 270 (e.g., the inner layer may be designed to optimally adhere to the inner sheath 270). Furthermore, the compliant member 290 may include an outer layer configured to conform to or imprint a support or constrained support. For example, the inner layer of the compliant member may include grafted polyolefins (e.g., The outer layer of the compliant component may include a thermoplastic elastomer (e.g., CHRONOPRENE). TM A portion of the inner sheath 270 may be made of polyether block amide (e.g., ) formed, and Inner layer can be with The inner sheath is joined or bonded (e.g., firmly bonded to it). In other words, Can be used in and Chronoprene TM The adhesive layer between each of them.

[0119] In some embodiments, the compliant member 290 may be configured to restrict or prevent longitudinal displacement of the constrained support. For example, the compliant member 290 may grip the constrained support, thereby restricting or preventing longitudinal displacement of the constrained support. In some embodiments, the compliant member 290 may be configured to restrict or prevent the constrained support from collapsing or folding (e.g., longitudinally folding over itself). For example, the compliant member 290 may provide axial support for the constrained support. Additionally, the compliant member 290 may be configured to partially surround one or more portions of the constrained support, meaning that the compliant member 290 may conform to at least a portion of the constrained support. For example, the compliant member 290 may conform to portions of the inner surface, shape, edge, and / or texture of the constrained support.

[0120] A constrained support (e.g., the inner surface of the constrained support) may be at least partially imprinted around the compliant member 290. In some embodiments, a helical support (e.g., a support having a helical support geometry) imprinted around the compliant member 290 may support the coil rows of the helical support. The imprinting of the helical support around the compliant member 290 may support each coil row of the helical support. In some other embodiments, a non-helical support (e.g., a support having a non-helical support geometry) imprinted around the compliant member 290 may support the coil rows of the non-helical support. The imprinting of the non-helical support around the compliant member 290 may support each coil row of the non-helical support.

[0121] In some embodiments, the presence of the compliant member 290 can increase the force required to shift or pull back the outer sheath 250 proximally. For example, the compliant member 290 and / or the restrained support disposed within the annular space 276 can induce or form a tighter fit between each of the inner sheath 270 and the outer sheath 250. However, at least in part due to the mechanical advantages available from the fitting device, as described above, the support can still be easily fitted by the user.

[0122] In various embodiments, the delivery catheter assembly 204 can be coupled to a dispensing device including an actuator, such that the actuator is similar to actuator 120. Actuator 120 can provide a mechanical advantage to the dispensing device. Furthermore, this mechanical advantage can assist a physician in using the dispensing device to dispense a stent positioned around the compliant member 290.

[0123] The compliant member 290 may be formed of one or more flexible, stretchable, moldable, tough, and / or soft materials. For example, the compliant member 290 may include one or more siloxanes, polyether block amides (e.g., ... ), thermoplastic elastomers (e.g., CHRONOPRENE) TM(and / or other suitable materials.) As discussed above, the compliance member 290 can be formed of a variety of materials (e.g., the compliance member 290 may comprise two or more layers). The compliance member 290 can be applied or disposed on the inner sheath 270 using impregnation, spraying, and / or reflow techniques. Other suitable methods for applying or disposing of the compliance member 290 to surfaces (e.g., the surface of the inner sheath 270) are also within the scope of this disclosure.

[0124] As shown, the compliant member 290 may extend longitudinally along a portion of the inner sheath 270 and / or through a portion of the annular space 276. The compliant member 290 may have a variable length. In some embodiments, the compliant member 290 may extend from near the proximal end of the distal tip 274 to a location near the distal end of the intermediate sheath 260. In some other embodiments, the compliant member 290 may extend along only a portion of the longitudinal distance between each of the proximal ends of the distal tip 274 and the distal end of the intermediate sheath 260. As shown, the distal end of the intermediate sheath may be located proximal to the compliant member 290.

[0125] The delivery catheter assembly 204 may be configured to receive and / or retain stents of varying lengths. In various embodiments, the length of the compliant member 290 may be greater than the length of the stent. In various other embodiments, the length of the compliant member 290 may be substantially equal to the length of the stent. In various other embodiments, the length of the compliant member 290 may be less than the length of the stent.

[0126] In some embodiments, the compliant member 290 may be longitudinally continuous along the length of the support. For example, the compliant member 290 may extend longitudinally along the entire length of the constrained support. In some embodiments, the compliant member 290 may be circumferentially continuous along the inner surface of the support. For example, the compliant member 290 may extend along the entire inner circumference of the constrained support.

[0127] The compliant member 290 can have varying hardness. In some embodiments, the hardness of the compliant member 290 can be about 10 to about 60 on the Shore A scale, about 15 to about 45 on the Shore A scale, about 20 to about 30 on the Shore A scale, about 23 to about 27 on the Shore A scale, or another suitable hardness. In some other embodiments, the hardness of the compliant member 290 can be about 25 on the Shore A scale.

[0128] The compliant member 290 may also have a range of wall thicknesses (e.g., the distance from the inner surface of the compliant member 290 to the outer surface of the compliant member 290). In some embodiments, the wall thickness of the compliant member 290 may be from about 0.0005 inches to about 0.050 inches, including from about 0.001 inches to about 0.050 inches or another suitable thickness.

[0129] In some embodiments, a compound or drug may be loaded in and / or on the outer surface of the compliance member 290. For example, an anticoagulant drug may be loaded in and / or coated thereon in the compliance member 290.

[0130] Similar to the discussion above regarding the distal tip 174, the distal tip 274 of the delivery sheath assembly 204 may be coupled to and / or integrally formed with the inner sheath 270. Furthermore, the inner cavity 272 may extend along the inner sheath 270 from the proximal end of the dispensing device 200 to the distal tip 274.

[0131] In some embodiments, the outer sheath 250 may be displaced proximally or progressively relative to each of the inner sheath 270 and the intermediate sheath 260. The distal end of the intermediate sheath 260 may engage or interact with the proximal end of the stent, thereby limiting or preventing the stent from being pulled back together with the outer sheath 250. Thus, the stent can be progressively exposed and allowed to self-deploy and adjust.

[0132] As discussed above with respect to the delivery catheter assembly 104, the outer sheath 250, the intermediate sheath 260, and / or the inner sheath 270 may be configured to have varying stiffness or other properties along their length.

[0133] Figure 13A This is a cross-sectional view as part of another embodiment of the delivery catheter assembly 304. Figure 13B This is a side view of a portion of the delivery catheter assembly 304, where the outer sheath ( Figure 13A (350) has been removed to show other components. As shown, the compliance member 390 may include a plurality of annular rings 392. Each of the annular rings 392 may be discrete or a single annular ring. In some embodiments, the annular rings 392 may be substantially uniformly spaced along a portion of the length of the inner sheath 370. In some other embodiments, the annular rings 392 may be spaced in an irregular pattern along a portion of the length of the inner sheath 370. In other words, the annular rings 392 may be intermittently arranged along a portion of the length of the inner sheath 370.

[0134] The annular rings 392 may be disposed partially around or around the inner sheath 370. As shown, each of the annular rings 390 of the compliance member 392 may be disposed around the circumference of the inner sheath 370. For example, each of the annular rings 390 of the compliance member 392 may be coupled to a portion of the outer surface of the inner sheath 370. In some embodiments, a subset of the annular rings 392 may completely surround the inner sheath 370, and another subset of the annular rings 392 may only partially surround the inner sheath 370.

[0135] Each of the annular rings 390 of the compliance member 392 may also be disposed within a portion of the annular space 376. In some embodiments, one or more of the annular rings 392 of the compliance member 390 may be configured to engage and / or retain a support or restrained support. In other words, one or more of the annular rings 392 of the compliance member 390 may at least partially grip, anchor, retain, and / or hold a support or restrained support.

[0136] In some embodiments, the stent may be disposed around: a first annular ring 392 configured to align with the distal end of the stent; a second annular ring 392 configured to align with the middle portion of the stent; and / or a third annular ring 392 configured to align with the proximal end of the stent. In some other embodiments, a plurality of annular rings 392 may be configured to align with only one of the distal, middle, or proximal ends of the stent. One or more annular rings 392 relative to other configurations (i.e., arrangements) of the stent are also within the scope of this disclosure.

[0137] The support can be constrained, rolled up, and / or loaded around one or more annular rings 392 of the compliance member 390. In addition, a portion of the loaded support (e.g., the inner surface of the loaded support) can be imprinted within a portion of one or more annular rings 392 of the compliance member 390 (e.g., the outer surface of one or more annular rings 392 of the compliance member 390).

[0138] A constrained support (e.g., the inner surface of a constrained support) may be at least partially imprinted around one or more annular coils 392 of the compliance member 390. In some embodiments, a helical support (e.g., a support having a helical support geometry) imprinted around one or more annular coils 392 of the compliance member 390 may support a coil row of the helical support. The imprinting of a helical support around one or more annular coils 392 of the compliance member 390 may support each coil row of the helical support. In some other embodiments, a non-helical support (e.g., a support having a non-helical support geometry) imprinted around one or more annular coils 392 of the compliance member 390 may support a coil row of the non-helical support. The imprinting of a non-helical support around one or more annular coils 392 of the compliance member 390 may support each coil row of the non-helical support.

[0139] As shown, the plurality of annular rings 392 of the compliant member 390 may extend longitudinally along a portion of the inner sheath 370 and / or through a portion of the annular space 376 (i.e., from the nearest annular ring 392 to the farthest annular ring 392). In some embodiments, the plurality of annular rings 392 of the compliant member 390 may extend from near the proximal end of the distal tip 374 to a position near the distal end of the intermediate sheath 360. In some other embodiments, the plurality of annular rings 392 of the compliant member 390 may extend along only a portion of the longitudinal distance between each of the proximal ends of the distal tip 374 and the distal end of the intermediate sheath 360. As shown, the distal end of the intermediate sheath 360 may be located proximal to the plurality of annular rings 392 of the compliant member 390.

[0140] The delivery catheter assembly 304 may be configured to receive and / or retain stents of varying lengths. In various embodiments, the length of the plurality of annular loops 392 of the compliant member 390 may be greater than the length of the stent (i.e., the length from the nearest annular loop 392 to the farthest annular loop 392). In various other embodiments, the length of the plurality of annular loops 392 of the compliant member 390 may be substantially equal to the length of the stent. In various other embodiments, the length of the plurality of annular loops 392 of the compliant member 390 may be less than the length of the stent.

[0141] Figure 12A yes Figure 11A A side view of the distal portion of the delivery catheter assembly 204 of the dispensing device 200 in a first state. Figure 12B and Figure 12C These are side views of the distal portion of the delivery catheter assembly 204 in the second and third states, respectively.

[0142] refer to Figure 12AThe support 35 can be constrained, coiled, or disposed around and / or within the annular space 276 of the compliant member 290. In a first state, as shown, the outer sheath 250 can be disposed above the support 35, thereby placing the support 35 in a constrained configuration. The constrained support 35 can extend only a portion of the compliant member 290 from the proximal end of the distal tip 274, thereby creating a gap or space along the compliant member 290 (e.g., between the proximal end of the constrained support 35 and the distal end of the intermediate sheath 260). In some embodiments, the constrained support 35 can extend substantially the entire length of the compliant member 290. In some other embodiments, the constrained support 35 can be longer than the compliant member 290. For example, in some cases, only a portion of the constrained support 35 is disposed within the compliant member 290.

[0143] Figure 12B The distal portion of the delivery catheter assembly 204 in its second state is shown. As shown, the distal portion of the delivery catheter assembly 204 can be positioned within a blood vessel 45 (e.g., a patient's blood vessel). For stent 35 deployment, the outer sheath 250 can be displaced proximally relative to the intermediate sheath 260, inner sheath 270, and / or the compliant member 290. For clarity, in Figure 12B and Figure 12C The pattern shown on the compliant member 290 is similar to, for example, in Figure 11D The pattern shown on the compliant member 290 differs in some respects. However, the provisions of this article... Figure 12B and Figure 12C The disclosure of the compliant component 290 and Figure 11D The compliance member 290 is related to this, and vice versa. In some embodiments, the outer sheath 250, the intermediate sheath 260, and / or the inner sheath 270 may be operatively coupled to the actuator, as discussed above with reference to the dispensing device 100. In some other embodiments, the outer sheath 250, the intermediate sheath 260, and / or the inner sheath 270 may be operatively coupled to the housing, as discussed above with reference to the dispensing device 100, and the housing may be operatively coupled to the actuator.

[0144] Furthermore, the displacement of the actuator can be configured to shift the outer sheath 250 relative to the inner sheath 270 and / or the intermediate sheath 260. As described above, some embodiments of the delivery catheter assembly 204 may exclude the intermediate sheath 260. Proximal displacement of the outer sheath 250 can expose a portion of the restrained stent 35, and thus the stent 35 can be at least partially configured. For example, with the compliance member 290 and a portion of the restrained stent 35 positioned distal to the distal end of the outer sheath 250, the distal portion of the stent 35 can be radially deployed and partially configured away from the compliance member 290.

[0145] In some embodiments, as described above, the dispensing device and / or actuator may be configured to dispense the stent 35 progressively. For example, the outer sheath 250 may be configured to displace proximally relative to the inner sheath 270, the compliance member 290, and the restrained stent 35 in a stepwise or incremental manner. In various embodiments, the compliance member 290 may facilitate or enhance the dispensing of the stent 35. For example, during the dispensing of the stent 35, the compliance member 290 may limit or prevent over-dispensing of the stent 35 (e.g., the stent 35 "jumping out" of the delivery catheter assembly 204 and / or the stent 35 jumping out of the inner sheath 270). Furthermore, for example, by limiting or preventing over-dispensing or jumping out of the stent, the compliance member 290 may enhance the accuracy of stent 35 dispensing.

[0146] In some embodiments, during stent 35 dispensing, the compliant member 290 can grip or support the constrained portion of the stent 35, thereby allowing the dispensing portion of the stent 35 to be pushed and / or shortened. For example, during stent 35 dispensing, the delivery catheter assembly 204 and / or dispensing device 200 can be moved or manipulated, thereby allowing a portion of the stent 35 (which is at least partially disposed in the compliant member 290) to be pushed and / or shortened.

[0147] In some embodiments, during stent 35 dispensing, the delivery catheter assembly 204 may be configured to adjust the length of the stent 35 (e.g., the stent 35 may be shortened), thereby allowing the user to select the length of the stent 35 based on characteristics such as patient anatomy (e.g., a customized length of the stent 35). In some embodiments, during stent 35 dispensing, the delivery catheter assembly 204 may have sufficient stiffness and / or dispensing control capability, thereby allowing the user to push and / or pull the stent 35 to control or determine the length of the stent 35. In various embodiments, the compliant member 290 may be configured such that the stent 35 can remain in communication (e.g., direct, physical communication) with the delivery catheter assembly 204 and / or the dispensing device 200 for the majority of stent 35 dispensing.

[0148] In some implementations, the stent may be configured to allow or permit nesting and / or extension of stent rows. For example, the stent may include multiple rows, each configured to be positioned around at least a portion of the outer surface of an adjacent row. This configuration can provide a stent in which the effective length of the stent can be adjusted during user deployment.

[0149] When fitting a portion of the stent 35, the stent 35 (e.g., the distal end of the stent 35) may be positioned against or engaged with the wall 47 of the blood vessel 45 (see example). Figure 12BPushing or pulling the stent 35 via the dispensing device 200 can compress the stent 35 (i.e., reduce the distance between the coils of the stent 35) and / or stretch the stent 35 (i.e., increase the distance between the coils of the stent 35) along a dispensed portion of the stent 35 that is not engaged with the wall 47. During such length adjustments, at least a portion of the undispensed portion of the stent 35 can be engaged by the compliant member 290. This configuration can provide the physician with enhanced flexibility during stent dispensing. For example, the physician can adjust the length of the stent 35 (e.g., by small adjustments) at or around branch vessels or other structures within the patient's body. Without the compliant member 290, the stent 35 may collapse or fold within the delivery catheter assembly 204 and / or the annular space 276 during the attempted length adjustments as described above.

[0150] Figure 12C The delivery catheter assembly 204 is shown in a third state, wherein the distal end of the outer sheath 250 has been displaced proximally relative to the proximal end of the stent 35. Therefore, in the third state, the stent 35 can be fully configured within the vessel 45. In some embodiments, the stent 35 can be configured such that it engages with or interacts with the wall 47 of the vessel 45.

[0151] This document discloses a method for preparing or loading a dispensing device 200. In some embodiments, the method of preparing the dispensing device 200 may include obtaining a delivery catheter assembly 204. The delivery catheter assembly 204 may include an outer sheath 250 and an inner sheath 270, wherein the inner sheath 270 is disposed within the outer sheath 250.

[0152] In some embodiments, the delivery catheter assembly 204 may further include an intermediate sheath 260 disposed between the outer sheath 250 and the inner sheath 270. Additionally, the distal end of the intermediate sheath 260 may be disposed proximal to the distal end of the outer sheath 250 and the distal end of the inner sheath 270.

[0153] In various embodiments, a method of preparing the dispensing device 200 may include applying a compliance member 290 to at least a portion of the inner sheath 270. For example, the compliance member 290 may be applied to an outer surface of the inner sheath 250, and the compliance member 290 may be coupled to the inner sheath 270. The compliance member 290 may be applied to the inner sheath 270 by at least one of impregnation, spraying, extrusion, reflow, or other suitable techniques.

[0154] As described above, the compliant member 290 may be configured to engage and / or retain the support 35. Furthermore, the support 35 may be disposed or positioned around at least a portion of the compliant member 290, and the support 35 may be constrained, coiled, or loaded within the compliant member 290.

[0155] The method of preparing the dispensing device 200 may further include placing an outer sheath 250 on a portion of the support 35. This configuration of the outer sheath 50 relative to the support 35 can help constrain the support 35 within the compliant member 290. When the support 35 is in the constrained configuration, the distal end of the intermediate sheath 260 may be positioned proximal to the proximal end of the compliant member 290.

[0156] A method for dispensing the stent 35 is also provided. In some embodiments, a delivery catheter assembly 204 may be obtained. The delivery catheter assembly 204 may include an outer sheath 250, an intermediate sheath 260, and an inner sheath 270. Furthermore, a compliance member 290 may surround a portion of the inner sheath 270. The method of dispensing the stent 35 may include positioning the stent 35 around the compliance member 290 and / or constraining the stent 35 within the compliance member 290. In various embodiments, the outer sheath 250 may also be disposed above the stent 35 (e.g., thereby constraining the stent 35 within a portion of the compliance member 290).

[0157] In some embodiments, the method of dispensing the stent 35 may further include displacing an actuator (e.g., an actuator operatively coupled to the delivery catheter assembly 204). The displacement of the actuator may be configured to displace the outer sheath 250 proximally relative to each of the compliance member 290 and the constrained stent 35, thereby partially dispensing the stent 35. As described above, the actuator 35 may be configured to progressively dispense the stent. Therefore, the method of dispensing the stent 35 may further include adjusting the position of the partially dispensed stent 35 after each actuator displacement. The actuator may be displaced and / or the position of the stent 35 may be adjusted until the stent 35 is fully dispensed. It will be understood that each of the methods provided herein may also be applied to the dispensing apparatus 100 and its components.

[0158] Figure 14 A perspective view of the dispensing device 400 is provided. The dispensing device 400 includes a handle assembly 400 adjacent to the proximal end of a dispensing device 402. An elongated delivery catheter assembly 404 extends distally from the handle assembly 402 to a distal tip or delivery tip 474. The handle assembly 402 may provide proximal user input, wherein one or more components are configured to allow a physician to dispense or otherwise manipulate a stent disposed within the delivery catheter assembly 404.

[0159] As discussed above with reference to the dispensing device 100, in use, the handle assembly 402 can be positioned outside the patient's body while the delivery catheter assembly 404 is advanced into the treatment location inside the patient's body. As detailed below, a stent can be disposed within a portion of the delivery catheter assembly 404, thereby allowing a physician to dispense a stent from the distal end of the delivery catheter assembly 404 by manipulating one or more components of the handle assembly 402.

[0160] Figure 15 yes Figure 14 A cross-sectional view of a portion of the dispensing device 400. Specifically, Figure 15 yes Figure 14 A side view of a portion of the dispensing device 400, when the dispensing device 400 is as follows: Figure 14 As shown in the positioning diagram, this portion is cut through a vertically extending section and intersects the longitudinal axis of the dispensing device 400. The longitudinal axis of the dispensing device 400 extends along the center of the delivery catheter assembly 404, including extending along the center of components of the delivery catheter assembly 404 that overlap with the handle assembly 402, such as the intermediate sheath 460. Figure 15 As shown.

[0161] As the handle assembly 402 is configured to be grasped or otherwise manipulated by a user, and the delivery catheter assembly 404 is configured to extend along a longitudinal axis to a treatment location within the patient's body, the delivery catheter assembly 404 extends distally away from the handle assembly 402. The proximal direction is the opposite, relating to the direction defined along the longitudinal axis, extending from the distal tip 474 toward the handle assembly 402.

[0162] Figure 15 The various internal components of the exposed handle assembly 402 are shown in cross-sectional view. A portion of the delivery catheter assembly 404 is also shown extending from the handle assembly 402. The handle assembly 402 includes a housing 410. As shown, the housing 410 surrounds certain parts of the handle assembly 402, thereby providing a gripping surface for the physician.

[0163] Actuator 420 is operatively coupled to housing 410. The manipulation of actuator 420 relative to housing 410 can be configured to engage a support, as detailed further below. In the illustrated embodiment, actuator 420 is rotatably coupled to housing 410 via pin 412. Pin 412 extends from housing 410 and may be integrally formed with one or more other portions of housing 410. As shown, pin 412 extends through pin hole 420 in actuator 422. Other arrangements for operatively coupling actuator 420 and housing 410, as discussed above with reference to actuator 120 and housing 110, are also within the scope of this disclosure.

[0164] Actuator 420 includes an input portion 422 extending from pin hole 421. In the illustrated embodiment, the input portion 421 includes a surface that is at least partially exposed relative to housing 410. In operation, a user can manipulate actuator 420 by applying force to the input portion 421, such as... Figure 15 As indicated by the arrow marked "Input"; the input section 421 is generally oriented towards the dispensing device ( Figure 14The longitudinal axis of the actuator 420 is shifted (400 in the middle); and the actuator 420 is rotated about the pin 412 relative to the housing 410. The displacement of the actuator 420 caused by the force indicated by the arrow marked "input" corresponds to the "pressing down" of the actuator 420 or "pressing down of the actuator 420 relative to the housing 410".

[0165] The actuator 420 may also include a transmission arm 422 extending from the pin hole 423. The transmission arm 423 may be rigidly coupled to the input portion 421, including embodiments in which both the transmission arm 423 and the input portion 421 are integrally formed with the remainder of the actuator 420. The transmission arm 423 extends to a ratchet sliding engagement portion 424. As the actuator 420 rotates about the pin 412, pressure on the input portion 421 in the direction indicated by the arrow labeled "input" displaces the transmission arm 423.

[0166] Therefore, the depressurization of the input portion 421 causes displacement of the ratchet sliding engagement portion 424 relative to the housing 410. This displacement of the ratchet sliding engagement portion 424 can be understood as a rotation about the pin 412, which has a proximal translational component and a vertical translational component, because the rotation of the input portion 421 in the direction indicated by the arrow marked "input" will cause the ratchet sliding engagement portion 424 (relative to the housing 410) to be displaced both proximally and vertically.

[0167] A spring 415 may be disposed between the actuator 420 and the housing 410. The spring 415 may be configured to resist displacement of the actuator 420 in the direction indicated by the arrow marked "input," and may be configured to return the actuator 420 to its original position after being pressed by the user. Figure 15 The relative positions are shown. When the handle assembly 402 is unconstrained, the spring 415 can therefore maintain (or return) the relative position of the actuator 420 with respect to the handle 410, as shown. Figure 15 As shown.

[0168] As the actuator 420 is pressed down relative to the housing 410, the spring 415 is compressed and the ratchet sliding engagement portion 424 is displaced as described above. Similarly, the displacement of the ratchet sliding engagement portion 424 relative to the housing 410 can be understood as having a proximal component and a vertical component.

[0169] The ratchet sliding engagement portion 424 is operably coupled to the ratchet slider 430, such that displacement of the ratchet sliding engagement portion 424 also displaces the ratchet slider 430. The ratchet slider 430 can be constrained such that it is configured to displace only proximally or distally relative to the housing 410. Therefore, the operable coupling of the ratchet sliding engagement portion 424 to the ratchet slider 430 allows for sliding interaction between the ratchet sliding engagement portion 424 and the ratchet slider 430, such that only the proximal or distal component of the displacement of the ratchet sliding engagement portion 424 is transmitted to the ratchet slider 430. In other words, the ratchet slider 430 can be displaced in a direction parallel to the longitudinal axis of the dispensing device 400, while the input displacement can be at an angle to the longitudinal axis of the dispensing device 400. It should be noted that in Figure 15 In the configuration shown, safety member 480 (similar to safety member 180) prevents proximal displacement of ratchet slider 430. Therefore, the discussion herein regarding the displacement of ratchet slider 430 and related components can be understood as disclosure relating to the configuration of handle assembly 402, in which safety member 480 has been removed.

[0170] When the actuator 420 is pressed down relative to the housing 410, the ratchet slider 430 can thus be displaced proximally relative to the housing 410. One or both of the ratchet slider 430 and the actuator 420 may also interact with the housing 410, thereby creating a positive stop to prevent the pressing down of the actuator 420 and / or the proximal displacement of the ratchet slider 430. This positive stop may be an engaging flange, shoulder, lug, pawl, or other feature attached to the housing 410, including features integrally formed on the housing 410. As shown, the positive stop may be located proximally to the proximal end of the ratchet slider 430. For example, the proximal end of the ratchet slider 430 may interact with a portion of the housing 410 (e.g., a flange, shoulder, etc.) located proximally to the proximal end of the ratchet slider 430. Therefore, during the depressing of the actuator 420, the handle assembly 402 can be configured to cause the ratchet slider 430 to move or "travel" as much as possible.

[0171] Therefore, when the actuator 420 is pressed down, the full stroke of the actuator 420 can correspond to the stroke from... Figure 15 The displacement shown is from the unconstrained position to the positive stop caused by the interaction with the housing 410. When the actuator 420 is pressed down, the partial stroke of the actuator 420 can correspond to the displacement from the unconstrained position to the positive stop caused by the interaction with the housing 410. Figure 15 The displacement from the unconstrained position shown to each and / or any position before positive stop caused by interaction with housing 410. Then, due to the biasing force provided by spring 415, releasing actuator 420 after full or partial stroke can cause actuator 420 to return to the unconstrained state. Figure 15The unconstrained state shown refers to the lack of constraint due to user input. In this state, spring 415 can be partially compressed, and the interaction between actuator 420 and housing 410 prevents actuator 420 from rotating about pin 412 in the direction opposite to the compression of actuator 420 or in the return direction. In other words, the interaction between actuator 420 and housing 410 (or a feature of housing 410) can also produce a positive stop on the return motion of actuator 420.

[0172] Continue to refer to Figure 15 During the depressurization of actuator 420, ratchet slider 430 can therefore be displaced proximally. Similarly, such displacement can correspond to a configuration where safety member 480 has been removed. Proximity displacement of ratchet slider 430 can also cause proximity displacement of carrier 440 due to the interaction between one or more carrier-engaging ratchet lugs 436 on ratchet slider 430 and ratchet sliding engagement arms 446 coupled to carrier 440. In some embodiments, carrier 440 may be coupled to outer sheath 450. For example, carrier 440 may be fixedly and / or rigidly coupled to outer sheath 450. In some embodiments, inner sheath 470 may be coupled to handle assembly 402. For example, inner sheath 470 may be fixedly and / or rigidly coupled to handle assembly 402.

[0173] Figure 16A yes Figure 14 and Figure 15 A perspective view of the ratchet slider 430 of the dispensing device 400. Figure 16B It is cut by a vertical plane set along the longitudinal centerline of the ratchet slider 430. Figure 16A A cross-sectional view of the ratchet slider 430. When the ratchet slider 430 is set... Figure 15 When the handle assembly 402 is inside the part, the cross section should intersect with the longitudinal axis of the dispensing device 400.

[0174] like Figure 15 , Figure 16A and Figure 16B As shown, the ratchet slider 430 may include a plurality of carrier-engaging ratchet lugs 436. The carrier-engaging ratchet lugs 436 may be spaced evenly apart along the longitudinal direction of the ratchet slider 430. As shown, the plurality of carrier-engaging ratchet lugs 436 may be arranged semi-continuously. For example, continuous carrier-engaging ratchet lugs 436 may be spaced apart by about 5 mm or less, about 4 mm or less, about 3 mm or less, about 2 mm or less, about 1 mm or less, or any other suitable distance. In the figures, exemplary carrier-engaging ratchet lugs are indicated by reference numeral 436, while the farthest carrier-engaging ratchet lug located at the distal end of the ratchet slider 430 is indicated by reference numeral 436a.

[0175] The ratchet slider 430 also includes a ratchet sliding safety opening 439 (similar to ratchet sliding safety opening 139). The ratchet slider 430 may also include an actuator engagement opening 434, which will be discussed in more detail below.

[0176] As described above, the interaction between the ratchet sliding engagement portion 424 of the actuator 420 and the ratchet slider 430 allows the ratchet slider 430 to be displaced proximally relative to the housing 410. As the ratchet slider 430 displaces proximally relative to the housing 410, engagement between the carrier 440 and one of the carrier-engaging ratchet lugs 436 also allows the carrier 440 to displace proximally. Figure 15 In the configuration, the ratchet sliding engagement arm 446 of the carrier 440 engages with the farthest carrier engagement ratchet lug 436a.

[0177] Figure 17 yes Figure 14 and Figure 15 A side view of the carrier 440 of the dispensing device 400. (See attached image.) Figure 17 As shown, the ratchet sliding engagement arm 446 extends radially away from the longitudinal axis of the carrier 440. When the carrier 440 is positioned... Figure 15 When the carrier 440 is inside the handle assembly 402, the longitudinal axis of the carrier 440 is set along the longitudinal axis of the dispensing device 400.

[0178] As shown, the ratchet sliding engagement arm 446 includes an angled portion or "toenail" portion 447 at its distal end. As shown, the angled portion 447 extends radially away from the longitudinal axis of the carrier 440 at an angle greater than the radial extension of the ratchet sliding engagement arm 446 relative to the longitudinal axis of the carrier 440. In some embodiments, the angled portion 447 can enhance the engagement between the ratchet sliding engagement arm 446 and a given carrier engagement ratchet lug 436 compared to a ratchet sliding engagement arm without the angled portion. For example, at least in part due to the semi-continuous arrangement of multiple carrier engagement ratchet lugs 436 (e.g., ...). Figure 16A and Figure 16B As shown, the angled portion 447 of the ratchet sliding engagement arm 446 allows or permits the ratchet sliding engagement arm 446 to radially deflect at least a portion of the ratchet slider 430, adjacent to or abutting, at or near a given carrier engagement ratchet lug 436. The angled portion 447 can provide clearance for the ratchet sliding engagement arm 446, thereby allowing the angled portion to engage the carrier engagement ratchet lug 436 (even when the spacing is close), while adjacent lugs do not interfere with the position of the ratchet sliding engagement arm 446 and prevent full engagement.

[0179] Figure 18 yes Figure 14 and Figure 15 A cross-sectional view of a portion of the dispensing device 400 shown. Specifically, the actuator 420, ratchet slider 430, and carrier 440 are... Figure 18 The text is a mix of Chinese characters and symbols, making it difficult to translate accurately. It appears to be a collection of fragments related to various topics, including online gaming, and possibly even phonetic expressions. Figure 15 They are in the same relative position and along the same cross section. Figure 18A yes Figure 18 A partial sectional view of a portion of the cross-sectional view. As shown, a portion of the ratchet slider 430 has been cut out in this view to show the engagement of the ratchet slider engagement 424 with the actuator engagement opening 434.

[0180] See Figures 15 to 18A During the compression of actuator 420 relative to housing 410, actuator 420 rotates about pin hole 422. This rotation causes displacement of ratchet sliding engagement portion 424 of actuator 420. Due to the interaction between ratchet sliding engagement portion 424 of actuator 420 and actuator engagement opening 434 of ratchet slider 430, the component of this displacement associated with the proximal displacement of ratchet sliding engagement portion 424 also causes ratchet slider 430 to translate proximally. In other words, when actuator 420 is displaced, the wall or surface defining actuator engagement opening 434 can contact ratchet sliding engagement portion 424, thereby causing ratchet slider 430 to displace.

[0181] Due to the interaction between the carrier engaging ratchet lug 436 and the ratchet sliding engagement arm 446, the proximal displacement of the ratchet slider 430 also causes the carrier 440 to shift proximally. In the illustrated embodiment, the distal surface of the angled portion 447 of the ratchet sliding engagement arm 446 contacts the proximal surface of the farthest carrier engaging ratchet lug 436a. This contact applies a proximal force on the distal surface of the angled portion 447 of the ratchet sliding engagement arm 446, thereby displacing the carrier 440 in a proximal direction. Therefore, the ratchet slider 430 and the carrier 440 will move proximally until the actuator 420 reaches the end of its stroke (e.g., partial or full stroke).

[0182] Figure 19 The outer shell 410 and the carrier 440 are in Figure 15 The sectional views shown are at the same relative positions. Figure 19 The cross-section extends along the longitudinal axis of the mixing device 400; however, Figure 19 The cross section is orthogonal to Figure 15 , Figure 16B and Figure 18 The cross-section extends horizontally.

[0183] like Figure 19 As shown, the carrier 440 includes a housing engagement arm 448 extending radially away from the longitudinal axis of the carrier 440. The housing 410 includes a plurality of carrier engagement housing lugs 418. Figure 19 In the figure, an exemplary carrier engagement housing lug is indicated by reference numeral 418, wherein the farthest carrier engagement housing lug is indicated by reference numeral 418a.

[0184] As shown, the housing engagement arm 448 includes an angled portion or "toenail" portion 449 at its distal end. As shown, the angled portion 449 extends radially away from the longitudinal axis of the carrier 440 at an angle greater than the radial extension of the housing engagement arm 448 relative to the longitudinal axis of the carrier 440. In some embodiments, the angled portion 449 can enhance the engagement between the housing engagement arm 448 and a given carrier engagement housing lug 418 compared to a housing engagement arm without the angled portion. For example, at least in part due to the semi-continuous arrangement of the plurality of carrier engagement ratchet lugs 418, the angled portion 449 of the housing engagement arm 448 can allow or permit the housing engagement arm 448 to radially deflect at or near a given carrier engagement housing lug 418, adjacent to or abutting at least a portion of the ratchet slider 430. Similar to the angled portion 447 discussed above, the angled portion 449 can provide a gap for the housing engagement arm 448, thereby allowing the angled portion 449 to engage the carrier engagement housing lug 418 (even when the spacing is close), while adjacent lugs do not interfere with the position of the housing engagement arm 448 and prevent full engagement.

[0185] See Figures 15 to 19 As the interaction between the actuator 420, the ratchet slider 430, and the carrier 440 causes the carrier 440 to shift relative to the housing 410 (as shown and described above), the housing engagement arm 448 of the carrier 440 (as...) Figure 19 (As shown) will deflect radially inward due to contact with one of the lugs 418 of the carrier engagement housing. For example, from Figure 19 Starting at the indicated position, as the interaction between the farthest carrier engagement ratchet lug 436a and the ratchet sliding engagement arm 446 of the carrier 440 pulls the carrier 440 proximally, the farthest carrier engagement housing lug 418a causes the housing engagement arm 448 to shift radially inward. The housing engagement arm 448 will continue to deflect radially inward until the distal end of the housing engagement arm 448 is positioned proximally to the farthest carrier engagement housing lug 418a, at which point the housing engagement arm 448 will return to its original position. Figure 19The radially outward configuration is shown. The point where the housing engagement arm 448 moves to the proximal side of the farthest carrier engagement housing lug 418a may correspond to the stroke of the actuator 420 (e.g., partial or full stroke), thereby causing engagement to occur at the end of the stroke between the housing engagement arm 448 and the next carrier engagement housing lug 418 (moving in the proximal direction). In some embodiments, each carrier engagement housing lug 418 (or at least a portion of each of the carrier engagement housing lugs 418) may be configured such that the position of the carrier engagement housing lug 418 corresponds to the position of the carrier engagement ratchet lug 436.

[0186] Furthermore, the stroke of actuator 420 can correspond to the displacement of carrier 440 as it passes through multiple carrier engagement housing lugs 418. For closely spaced carrier engagement housing lugs 418, actuator 420 can thus be configured to displace carrier 440 within a semi-continuous range as carrier 440 advances along the carrier engagement lugs 418. Partially pressing actuator 420 can cause carrier 440 to move along and through the carrier engagement housing lugs 418, and upon release of actuator 420, carrier 440 can remain engaged with the most recently passed carrier engagement lug 418. Therefore, the increment in displacement of carrier 440 can correspond to the spacing of the carrier engagement lugs 418, rather than the length of the stroke of actuator 420.

[0187] As the actuator 420 is released after its stroke, the interaction between the spring 415, the housing 410, and the actuator 420 will cause the actuator 420 to return to the unrestrained position as described above. Figure 15 (as shown in the diagram). Therefore, the corresponding rotation of the actuator 420 about the pin hole 422 will be associated with the displacement of the ratchet sliding engagement portion 424, including the displacement component in the distal direction. Then, the interaction between the ratchet sliding engagement portion 424 and the actuator engagement opening 434 will be associated with the distal displacement of the ratchet slider 430. Therefore, when the actuator 420 is released at the end of its stroke, the actuator 420, spring 415, and ratchet slider 430 return to the same position relative to the housing 410, as shown in the diagram. Figure 15 As shown.

[0188] However, when the actuator 420 returns to the unconstrained position, the interaction between the housing engagement arm 448 and the carrier engagement housing lug 418 prevents distal displacement of the carrier 440. Specifically, the distal surface of the angled portion 449 of the housing engagement arm 448 contacts the proximal surface of the carrier engagement housing lug 418, and this interaction prevents the carrier 440 from returning to the pre-stroke position. In the exemplary stroke discussed above, the distal carrier engagement housing lug 418a displaces the housing engagement arm 448 during the stroke, and the housing engagement arm 448 engages with the distal carrier engagement housing lug 418a after the stroke. Subsequent strokes cause the carrier 440 to move in the proximal direction along the plurality of carrier engagement housing lugs 418.

[0189] As the actuator 420 returns to the unconstrained state, the radial inward displacement of the ratchet sliding engagement arm 446 of the carrier 440 allows the ratchet slider 430 to move distally relative to the carrier 440, since the engagement between the carrier 440 and the carrier engagement housing lug 418 prevents distal displacement of the carrier 440.

[0190] See Figures 15 to 19 For details, please refer to Figure 18 In the view, the distal displacement of the ratchet slider 430 relative to the carrier 440 creates an interaction between the carrier engaging ratchet lug 436 and the angled portion 447 of the ratchet sliding engagement arm 446, causing the ratchet sliding engagement arm 446 to shift radially inward. The proximal-facing surfaces of the carrier engaging ratchet lug 436 can be angled to facilitate this interaction. During the depressurization of the actuator 420, engagement between the distal carrier engaging ratchet lugs 436a causes the carrier 440 to shift in the proximal direction; during the retraction of the actuator 420, another carrier engaging ratchet lug 436 (in the proximal direction) causes radially inward displacement of the ratchet sliding engagement arm 446 until the angled portion 447 of the ratchet sliding engagement arm 446 is proximal to the carrier engaging ratchet lug 436. At this point, the ratchet sliding engagement arm 446 returns to a radially outward position (with...). Figure 18 (Similar to the position shown), but the distal surface of the angled portion 447 of the ratchet sliding engagement arm 446 now engages with the proximal side of the other carrier engagement ratchet lug 436 (again along the proximal direction).

[0191] During the full stroke, engagement between the first carrier engaging ratchet lugs 436 allows the carrier 440 to shift in the proximal direction; during the return of the actuator 420, as the angled portion 447 of the ratchet sliding engagement arm 446 moves proximal relative to the plurality of carrier engaging ratchet lugs 436 during the full stroke, a plurality of subsequent carrier engaging ratchet lugs 436 (in the proximal direction) can cause a plurality of radially inward displacements of the ratchet sliding engagement arm 446. At this time, the angled portion 447 of the ratchet sliding engagement arm 446 returns to a radially outward position (with...). Figure 18 (Similar to the position shown), but the distal surface of the angled portion 447 of the ratchet sliding engagement arm 446 now engages with the proximal side of the second carrier engagement ratchet lug 436 (again in the proximal direction). In this configuration, multiple carrier engagement ratchet lugs 436 can be positioned between the first carrier engagement ratchet lug 436 engaged during the stroke and the second carrier engagement ratchet lug 436 engaged at the end of the same stroke. For example, one, two, three, four, five, six or more carrier engagement ratchet lugs 436 can be positioned between the first carrier engagement ratchet lug 436 engaged during a single stroke and the second carrier engagement ratchet lug 436 engaged at the end of a single stroke.

[0192] The displacement of the ratchet slider 430, sufficient to move it to engage with the subsequent carrier engagement ratchet lug 436, corresponds to the magnitude of the ratchet slider 430 displacement, which corresponds to the return of the actuator 420. A single return of the actuator 420 after at least a partial stroke can move the ratchet slider 430, thereby allowing multiple carrier engagement ratchet lugs 436 to engage with the carrier 440 in series during the stroke.

[0193] Therefore, as described above, pressing the actuator 420 to its full stroke and then allowing it to return to the unconstrained position causes the carrier 440 to shift relative to the housing 410 in discrete increments, corresponding to the longitudinal distance between the plurality of carrier engaging housing lugs 418. Pressing the actuator 420 to a partial stroke and then allowing it to return to the unconstrained position causes the carrier 440 to shift relative to the housing 410 in discrete increments, corresponding to the longitudinal distance between adjacent carrier engaging housing lugs 418.

[0194] As detailed below, the relative position of the carrier 440 with respect to the housing 410 can be related to the degree of stent placement from the dispensing device 400. Therefore, during use of the dispensing device 400, visual, auditory, and tactile feedback regarding the position of the carrier 440 provides the user with information about stent placement. This information can be associated with increased control during placement, as the physician can quickly and intuitively infer the degree of stent placement.

[0195] In some configurations, at least a portion of the elongated delivery catheter assembly 404 may be extended and / or stretched during use of the dispensing device 400. Configurations of the dispensing device 400 (e.g., including a semi-continuous arrangement of multiple carrier-engaging ratchet lugs 436) may allow or permit more than one increment of displacement of the carrier 440 relative to the ratchet slide 430. Furthermore, configurations of the dispensing device 400 may allow or permit fine-tuning of the stent. For example, the stent may be dispensed in increments of approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, or any other suitable increment.

[0196] The displacement increments of the carrier 440 can be approximately 0.5 mm, approximately 1 mm, approximately 2 mm, approximately 3 mm, approximately 4 mm, approximately 5 mm, approximately 10 mm, approximately 25 mm, approximately 50 mm, approximately 100 mm, or any other suitable displacement increment. The incremental displacement of the carrier 440 can further facilitate partial stent placement, thereby allowing physicians to incrementally place the stent, potentially adjusting or confirming the stent's position between these increments.

[0197] It is believed that those skilled in the art will make the fullest use of this disclosure using the foregoing description without further detailed description. The embodiments and implementations disclosed herein should be understood as illustrative and exemplary only, and not as limiting the scope of this disclosure in any way. It will be apparent to those skilled in the art, and those who benefit from this disclosure, that changes may be made to the details of the above embodiments without departing from the basic principles of this disclosure.

Claims

1. A prosthesis fitting device, comprising: The prosthesis delivery catheter assembly includes: Outer sheath; Inner sheath, the inner sheath being disposed within the outer sheath, the inner sheath comprising a first outer diameter; and A delivery tip, disposed at the distal end of the inner sheath, the delivery tip comprising: The distal part; Proximal portion; The lumen extends from the distal portion to the proximal portion; and A shoulder portion is disposed between the distal portion and the proximal portion, the shoulder portion having a transition from the distal portion to the proximal portion where the outer diameter of the delivery tip decreases. The proximal portion includes: A shaft, the shaft including a second outer diameter greater than the first outer diameter; and The proximal end includes a transition from the first outer diameter to the second outer diameter facing proximally. The delivery tip, from its distal end to its proximal end, comprises the following shape: an inclined conical surface deviating from the longitudinal axis of the delivery tip from the distal end to the shoulder; a transition where the outer diameter of the delivery tip decreases from the distal portion to the proximal portion; the axis; and a transition from the first outer diameter to the second outer diameter facing proximal. A compliant member, surrounding a portion of the outer surface of the inner sheath, is configured to engage a restrained prosthesis. The compliant member extends longitudinally along the entire length of the constrained prosthesis. The compliant component comprises an inner layer and an outer layer, the inner layer being configured to connect with the inner sheath, and the outer layer being configured to imprint the restrained prosthesis. The inner layer of the flexible component comprises grafted polyolefin. The outer layer of the flexible member comprises a thermoplastic elastomer, and The inner sheath is a polyether block amide; and An actuator operatively coupled to the outer sheath and configured to translate the outer sheath proximally relative to the restrained prosthesis to accommodate the restrained prosthesis.

2. The prosthesis fitting device according to claim 1, wherein, The proximal transition includes an inclined surface.

3. The prosthesis fitting device according to claim 1, in, The outer sheath includes an inner cavity, and The shaft can be disposed within the inner cavity.

4. The prosthesis fitting device according to claim 1, in, The inner sheath includes an inner cavity, and The delivery tip includes an inner cavity that communicates with the inner cavity of the inner sheath.

5. The prosthesis fitting device according to claim 1, wherein, The distal portion includes a radially inward tapering shape extending from the shoulder to the distal end of the distal portion.

6. The prosthesis fitting device according to claim 1, wherein, The delivery tip comprises nylon material.

7. The prosthesis fitting device according to claim 6, wherein, The nylon material is a polyether block amide.

Images