Constrained delivery-hinge and constrained delivery-buckle

Abstract

A method of delivering a medical device includes surrounding a deployment portion of the medical device with a cannula, the cannula including a cannula wall and a fixing portion, the fixing portion being positioned on the cannula wall and actuable between a fixed state and an unfixed state, the cannula being configured to cover the deployment portion to be delivered together with the deployment portion and to facilitate its movement through a delivery cavity during delivery of the medical device, and being configured to radially move between an expanded and a constrained state via actuation of the fixing portion, such that the cannula is in a constrained state and an expanded state when the fixing portion is in the fixed and unfixed states, respectively; inserting the deployment portion and the cannula together into a body cavity, wherein the cannula is in the fixed state; changing the cannula from the fixed state to the unfixed state; and withdrawing the cannula from the body cavity.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of provisional application number 63 / 129,211, filed on December 22, 2020, which is incorporated herein by reference in its entirety. Technical Field

[0003] This field relates to delivery aids for percutaneous circulatory support devices. More specifically, the present invention relates to delivery sleeves for integrated braided cannulas in circulatory support pumps. Background Technology

[0004] Circulatory support devices support the heart's pumping action. These devices can be located through valvular openings, such as, for example, the aortic valve. Typically, circulatory support devices have a polymer coating, such as a protective mesh, for underlying components. However, this coating can make the circulatory support device resistant to travel through the lumen used to deliver such a device to the treatment site. Summary of the Invention

[0005] In Example 1, a delivery device for a percutaneous medical device includes a cannula and a tether assembly. The cannula includes a cannula wall and a fixing portion positioned on the cannula wall, and the fixing portion is actuable between a fixed state and an unfixed state. The cannula is configured to cover a deployment portion of the percutaneous medical device for delivery together with the deployment portion and to facilitate its movement through a delivery cavity during delivery of the percutaneous medical device. The cannula is also configured to move radially between a constrained state and an expanded state via actuation of the fixing portion, such that the cannula is in a constrained state when the fixing portion is in a fixed state and in an expanded state when the fixing portion is in an unfixed state. The tether assembly engages the cannula and is configured to actuate the fixing portion between a fixed state when the percutaneous medical device is being delivered and an unfixed state prior to deployment of the deployment portion of the percutaneous medical device. The tether assembly is also configured to facilitate withdrawal of the cannula from the covered deployment portion when the cannula is in the expanded state and to facilitate withdrawal of the cannula from the delivery cavity.

[0006] In Example 2, according to the delivery device of Example 1, the cannula is a restraining cannula configured to restrain the deployment portion such that the deployment portion is restrained when the percutaneous medical device is delivered and is unrestrained once the deployment portion has been deployed.

[0007] In Example 3, the conveying device according to any one of Examples 1 and 2, wherein the tether assembly includes a plurality of tethers, including a first tether and a second tether, wherein the first tether is configured to actuate the fixed portion from a fixed state to an unfixed state, and wherein the second tether is configured to facilitate the extraction of the sleeve from the covered deployment portion when the sleeve is in an expanded state, and to facilitate the extraction of the sleeve from the conveying cavity.

[0008] In Example 4, the conveying device according to any one of Examples 1, 2 and 3, wherein the sleeve includes a sheet having a first edge and a second edge; wherein the fixing portion includes removably fixing the first edge and the second edge; wherein removably fixing the first edge to the second edge includes tying the first edge and the second edge together; and wherein the tether assembly is configured to untie the first edge and the second edge.

[0009] In Example 5, the conveying device according to any one of Examples 1, 2 and 3, wherein the sleeve includes a film, and the fixing portion includes a divisible portion of the film; wherein the film is a single continuous film having a first edge and a second edge such that the first and second edges are opposite edges of the single continuous film; wherein the divisible portion includes the first and second edges; and wherein the tether assembly is configured to separate the first edge from the second edge.

[0010] In Example 6, the delivery device according to any one of Examples 1 to 5, wherein the cannula provides a lower delivery force than a percutaneous medical device.

[0011] In Example 7, a delivery assembly for a percutaneous medical device includes an introducer and a delivery device; the introducer is configured to removably receive a deployment portion of the percutaneous medical device within a delivery cavity of the introducer; and the delivery device for the percutaneous medical device includes a cannula and a tether assembly, the cannula including a cannula wall and a fixing portion, the fixing portion being positioned on the cannula wall and actuable between a fixed state and an unfixed state, the cannula being configured to cover the deployment portion of the percutaneous medical device for delivery together with the deployment portion during delivery of the percutaneous medical device and to facilitate its movement through the delivery cavity, the cannula also... The cannula is configured to move radially between an expanded state and a constrained state via actuation of a fixed portion, such that the cannula is in a constrained state when the fixed portion is in a fixed state and in an expanded state when the fixed portion is in an unfixed state; and the tether assembly engages the cannula and is configured to actuate the fixed portion between a fixed state when the percutaneous medical device is being delivered and an unfixed state before the deployment portion of the percutaneous medical device is deployed, the tether assembly being further configured to facilitate the withdrawal of the cannula from the covered deployment portion when the cannula is in the expanded state, and to facilitate the withdrawal of the cannula from the delivery cavity.

[0012] In Example 8, the delivery assembly according to Example 7 is provided, wherein the cannula is a constraint cannula configured to constrain the deployment portion such that the deployment portion is constrained during delivery of the percutaneous medical device and unconstrained once the deployment portion has been deployed.

[0013] In Example 9, the delivery assembly according to any one of Examples 7 and 8, wherein the tether assembly includes a plurality of tethers, including a first tether and a second tether, wherein the first tether is configured to actuate the fixed portion from a fixed state to an unfixed state, and wherein the second tether is configured to facilitate the extraction of the sleeve from the covered deployment portion when the sleeve is in an expanded state, and to facilitate the extraction of the sleeve from the delivery cavity.

[0014] In Example 10, the delivery assembly according to any one of Examples 7, 8 and 9, wherein the sleeve includes a sheet having a first edge and a second edge; wherein the fixing portion includes removably fixing the first edge and the second edge; wherein removably fixing the first edge to the second edge includes tying the first edge and the second edge together; and wherein the tether assembly is configured to untie the first edge and the second edge.

[0015] In Example 11, the delivery assembly according to any one of Examples 7, 8 and 9, wherein the sleeve includes a film, and the fixing portion includes a divisible portion of the film; wherein the film is a single continuous film having a first edge and a second edge such that the first and second edges are opposite edges of the single continuous film; wherein the divisible portion includes the first and second edges; and wherein the tether assembly is configured to separate the first edge from the second edge.

[0016] In Example 12, the delivery assembly according to any one of Examples 7 to 11, wherein the cannula provides a lower delivery force than a percutaneous medical device.

[0017] In Example 13, a method of delivering a percutaneous medical device may include surrounding a deployment portion of the percutaneous medical device with a cannula, the cannula including a cannula wall and a fixing portion positioned thereon and actuable between a fixed state and an unfixed state, the cannula being configured to cover the deployment portion of the percutaneous medical device to be delivered together with the deployment portion during delivery of the percutaneous medical device and to facilitate its movement through a delivery cavity, the cannula also being configured to move radially between an expanded state and a constrained state via actuation of the fixing portion, such that it is in a constrained state when the fixing portion is in a fixed state and in an expanded state when the fixing portion is in an unfixed state; and inserting the deployment portion of the percutaneous medical device together with the cannula into a body cavity, wherein the cannula is in a fixed state; changing the cannula from a fixed state to an unfixed state; and withdrawing the cannula from the body cavity.

[0018] In Example 14, according to the method of Example 13, it further includes inserting a percutaneous medical device together with a cannula into an implanter, and wherein inserting the deployment portion includes inserting the implanter into a body cavity and moving the deployment portion distally relative to the implanter such that the deployment portion is outside the implanter.

[0019] In Example 15, according to the method of any one of Examples 13 and 14, the tether assembly is configured to switch the cannula from a fixed state to an unfixed state and withdraw the cannula from the body cavity; wherein the first tether of the tether assembly is configured to switch the cannula from a fixed state to an unfixed state; and wherein the second tether of the tether assembly is configured to withdraw the cannula from the body cavity.

[0020] In Example 16, a delivery device for a percutaneous medical device may include a cannula and a tether assembly. The cannula includes a cannula wall and a fixing portion, the fixing portion being positioned on the cannula wall and actuable between a fixed state and an unfixed state. The cannula is configured to cover a deployment portion of the percutaneous medical device for delivery with the deployment portion during delivery of the percutaneous medical device and to facilitate its movement through a delivery cavity. The cannula is also configured to move radially between a constrained and expanded state via actuation of the fixing portion, such that the cannula is in a constrained state when the fixing portion is in a fixed state and in an expanded state when the fixing portion is in an unfixed state. The tether assembly engages the cannula and is configured to actuate the fixing portion between a fixed state when the percutaneous medical device is being delivered and an unfixed state prior to deployment of the deployment portion of the percutaneous medical device. The tether assembly is also configured to facilitate withdrawal of the cannula from the covered deployment portion when the cannula is in the expanded state and to facilitate withdrawal of the cannula from the delivery cavity.

[0021] In Example 17, the delivery device according to Example 16 is provided, wherein the cannula is a restraining cannula configured to restrain the deployment portion such that the deployment portion is restrained during delivery of the percutaneous medical device and is unrestrained once the deployment portion has been deployed.

[0022] In Example 18, the conveying device according to Example 16 is provided, wherein the tether assembly includes a plurality of tethers, including a first tether and a second tether, wherein the first tether is configured to actuate the fixed portion from a fixed state to an unfixed state, and wherein the second tether is configured to facilitate the extraction of the sleeve from the covered deployment portion when the sleeve is in an expanded state, and to facilitate the extraction of the sleeve from the conveying cavity.

[0023] In Example 19, the conveying device according to Example 16 is provided, wherein the sleeve comprises a sheet having a first edge and a second edge, and wherein the fixing portion comprises removably fixing the first edge and the second edge.

[0024] In Example 20, according to the conveying device of Example 19, removably securing the first edge to the second edge includes tying the first edge and the second edge together; and wherein the tether assembly is configured to untie the first edge and the second edge.

[0025] In Example 21, the conveying device according to Example 16 is provided, wherein the sleeve comprises a film, and the fixing portion comprises a divisible portion of the film.

[0026] In Example 22, the conveying device according to Example 21 is wherein the film is a single continuous film having a first edge and a second edge such that the first and second edges are opposite edges of the single continuous film; wherein the divisible portion includes the first and second edges; and wherein the tether assembly is configured to separate the first edge from the second edge.

[0027] In Example 23, the delivery device according to Example 16 is provided, wherein the cannula provides a lower delivery force than a percutaneous medical device.

[0028] In Example 24, a delivery assembly for a percutaneous medical device may include an introducer and a delivery device; the introducer is configured to removably receive a deployment portion of the percutaneous medical device within a delivery cavity of the introducer; and the delivery device for the percutaneous medical device may include a cannula and a tether assembly, the cannula including a cannula wall and a fixing portion, the fixing portion being positioned on the cannula wall and actuable between a fixed state and an unfixed state, the cannula being configured to cover the deployment portion of the percutaneous medical device so as to deliver it together with the deployment portion and facilitate its movement through the delivery cavity during delivery of the percutaneous medical device. The cannula is also configured to move radially between an expanded state and a constrained state via actuation of the fixed portion, such that the cannula is in a constrained state when the fixed portion is in a fixed state and in an expanded state when the fixed portion is in an unfixed state; and the tether assembly engages the cannula and is configured to actuate the fixed portion between a fixed state when the percutaneous medical device is being delivered and an unfixed state before the deployment portion of the percutaneous medical device is deployed, the tether assembly being further configured to facilitate the withdrawal of the cannula from the covered deployment portion when the cannula is in the expanded state, and to facilitate the withdrawal of the cannula from the delivery cavity.

[0029] In Example 25, the delivery assembly according to Example 24 is provided, wherein the cannula is a constraint cannula configured to constrain the deployment portion such that the deployment portion is constrained during delivery of the percutaneous medical device and unconstrained once the deployment portion has been deployed.

[0030] In Example 26, the delivery assembly according to Example 24 is provided, wherein the tether assembly includes a plurality of tethers, including a first tether and a second tether, wherein the first tether is configured to actuate the fixed portion from a fixed state to an unfixed state, and wherein the second tether is configured to facilitate the extraction of the sleeve from the covered deployment portion when the sleeve is in an expanded state, and to facilitate the extraction of the sleeve from the delivery cavity.

[0031] In Example 27, the delivery assembly according to Example 24 is provided, wherein the sleeve comprises a sheet having a first edge and a second edge, and wherein the fixing portion comprises removably fixing the first edge and the second edge.

[0032] In Example 28, the delivery assembly according to Example 27 is provided, wherein removably securing the first edge to the second edge includes tying the first edge and the second edge together; and wherein the tether assembly is configured to untie the first edge and the second edge.

[0033] In Example 29, the delivery assembly according to Example 24 is provided, wherein the sleeve comprises a film, and the fixing portion comprises a divisible portion of the film.

[0034] In Example 30, the conveying assembly according to Example 29 is provided, wherein the film is a single continuous film having a first edge and a second edge such that the first and second edges are opposite edges of the single continuous film; wherein the divisible portion includes the first and second edges; and wherein the tether assembly is configured to separate the first edge from the second edge.

[0035] In Example 31, the delivery assembly according to Example 24 is provided, wherein the cannula provides a lower delivery force than a percutaneous medical device.

[0036] In Example 32, a method of delivering a percutaneous medical device may include surrounding a deployment portion of the percutaneous medical device with a cannula, the cannula including a cannula wall and a fixing portion, the fixing portion being positioned on the cannula wall and actuable between a fixed state and an unfixed state, the cannula being configured to cover the deployment portion of the percutaneous medical device to be delivered together with the deployment portion during delivery of the percutaneous medical device and to facilitate its movement through a delivery cavity, the cannula also being configured to radially move between an expanded state and a constrained state via actuation of the fixing portion, such that it is in a constrained state when the fixing portion is in a fixed state and in an expanded state when the fixing portion is in an unfixed state; and inserting the deployment portion of the percutaneous medical device together with the cannula into a body cavity, wherein the cannula is in a fixed state; changing the cannula from a fixed state to an unfixed state; and withdrawing the cannula from the body cavity.

[0037] In Example 33, the method according to Example 32 further includes inserting a percutaneous medical device together with a cannula into an implanter, wherein inserting the deployment portion includes inserting the implanter into a body cavity and moving the deployment portion distally relative to the implanter such that the deployment portion is outside the implanter.

[0038] In Example 34, the method described in Example 32 is used, wherein the tether assembly is configured to switch the cannula from a fixed state to an unfixed state and withdraw the cannula from the body cavity.

[0039] In Example 35, according to the method of Example 34, the first tether of the tether assembly is configured to switch the cannula from a fixed state to an unfixed state; and the second tether of the tether assembly is configured to withdraw the cannula from the body cavity.

[0040] While several embodiments have been disclosed, other embodiments of the invention will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative embodiments of the invention. Therefore, the drawings and detailed description are to be regarded as illustrative rather than restrictive in nature. Attached Figure Description

[0041] Figure 1A A conceptual diagram of a cyclic support device including a cannula and an adapter according to various aspects of the present invention is depicted.

[0042] Figure 1B The invention describes aspects including a pump in Figure 1A The side view of the cyclic support device depicted in the figure.

[0043] Figure 2 A side view of a conveying assembly according to various aspects of the present invention is depicted.

[0044] Figure 3A A first example of a sleeve in a constrained configuration according to various aspects of the invention is depicted.

[0045] Figure 3B A first example of a sleeve in an expanded configuration according to various aspects of the present invention is depicted.

[0046] Figure 4A A second example of a sleeve in a constrained configuration according to various aspects of the invention is depicted.

[0047] Figure 4B The invention describes aspects of the invention in an expanded form. Figure 4A The second example of the sleeve in the example.

[0048] Figure 5 A flowchart illustrating methods according to various aspects of the present invention is provided.

[0049] While various aspects of the invention are adaptable to numerous modifications and alternatives, specific embodiments thereof have been shown by way of example in the accompanying drawings and will be described in more detail below. However, the invention is not limited to the particular embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims. Detailed Implementation

[0050] This invention includes a cyclic support device that has a reduced conveying force compared to conventional embodiments. To facilitate an understanding of the principles of the invention, reference is now made to the examples shown in the accompanying drawings, which will be described below. The examples disclosed herein are not intended to be exhaustive or to limit the invention to the precise forms disclosed in the detailed description below. Rather, these exemplary embodiments have been chosen and described to enable others skilled in the art to use their teachings. Having multiple (e.g., all) features in a given example used across all examples does not exceed the scope of the invention. Therefore, no single figure should be construed as having any dependency or requirement associated with any single component or combination of components shown herein. Additionally, in the examples, the various components depicted in a given figure may be integrated with various components in other components (and / or components not shown) depicted herein, all of which are considered to be within the scope of the invention.

[0051] Figure 1A A conceptual diagram depicts a circulatory support device 102 including a cannula 104 and an adapter 108, according to an embodiment of the subject matter disclosed herein. The circulatory support device 102 is shown disposed within a heart 110. According to an embodiment, the circulatory support device 102 may include a ventricular assist device (VAM). Figure 1B As shown in the diagram, a pump, such as a ventricular assist device, is connected to the cannula 104 via an adapter 108. The ventricular assist device is configured to pump blood from the subject's left ventricle 112 into the subject's aorta 114. In embodiments, the circulatory support device 102 can be used to treat cardiogenic shock and other modes of heart failure.

[0052] In one embodiment, the distal portion 116 of the circulatory support device 102 is positioned within the left ventricle 112. The intermediate portion 118 of the circulatory support device 102 extends through the aortic valve 120, such that the proximal portion 122 of the cannula 104 extends into the aorta 114. In another embodiment, the proximal portion 122 of the cannula 104 is coupled to an adapter 108, which in turn is coupled to the circulatory support device 102. During operation, the circulatory support device 102 draws blood from the left ventricle 112, through the cannula 104, and releases it into the aorta 114. Alternatively or additionally, the circulatory support device 102 may be used to facilitate the pumping of blood from certain aspects of a subject's blood vessels into adjacent portions of the vessels.

[0053] Figure 1B The following describes an embodiment of the subject matter disclosed herein, including a ventricular assist device 103. Figure 1A The side view of the cyclic support device 102 shown.

[0054] As described above, the cannula 104 may include a proximal portion 122, a middle portion 118, and a distal portion 116. The middle portion 118 may include a braided mesh 124 extending between the proximal portion 122 and the distal portion 116. In embodiments, the braided mesh 124 may have various braiding angles and / or different braiding angles, as explained in more detail below. In an embodiment, the proximal portion 126 of the braided mesh 124 may be tapered. The tapered proximal portion 126 allows the braided mesh 124 to transition from a larger diameter (e.g., greater than or equal to 5 millimeters (mm)) near the distal end 128 of the proximal portion 126 to a smaller diameter near the proximal end 130 of the braided mesh 124. In an embodiment, the braided mesh 124 may collapse to a smaller diameter for delivery into the heart 110. Once positioned within the heart 110, the braided mesh 124 may expand to its larger diameter. By being able to expand to a diameter larger than its delivery configuration, the cannula 104 can provide a greater flow rate than a non-expandable cannula 104 with a smaller diameter. In an embodiment, the braided mesh 124 may be designed to fully withstand the pressure gradient between the inside and outside of the cannula 104.

[0055] In one embodiment, the braided mesh 124 is coated with a membrane to form a conduit through the cannula 104 from the distal portion 116 to the proximal portion 122. In another embodiment, the membrane may be silicone. In another embodiment, the cannula 104 is formed from multiple nitinol wires with a diameter of 0.008”. However, this is only one example, and other types of wires with other diameters may be used to form the cannula 104. Alternatively or alternatively, wires with different diameters may be used to form the cannula 104. In another embodiment, the cannula 104 may be formed from a series of nitinol wires (e.g., 6 to 48 wires). While protective, the membrane coated on the braided mesh 124 may have a considerably resistive exterior, which may prove troublesome during delivery of the circulatory support device 102, for example, by increasing the delivery force required to advance the cannula 104 through the delivery cavity during setup and / or operation.

[0056] Turning Figure 2 The figure illustrates a delivery assembly 200 for a percutaneous medical device 102, such as a circulatory support device 102. The percutaneous medical device 102 includes a deployment portion 104, such as a cannula 104. For illustrative purposes, the proximal direction is from right to left in the figure, and the distal direction is from left to right in the figure. Furthermore, in the following text, for ease of description, the percutaneous medical device 102 will generally be referred to as 102, and the deployment portion 104 will generally be referred to as 104. However, it should be noted that it is also conceivable to use the delivery assembly 200 in conjunction with other percutaneous medical devices 102 and their deployment portions, and therefore does not depart from the scope of the invention.

[0057] Considering the resistivity of the membrane, the delivery assembly 200 may include an introducer 204, a delivery cavity 206 formed in the introducer 204, and a delivery means 210 for assisting in the delivery of the percutaneous medical device 102. The delivery cavity 206 may be configured to removably receive the deployment portion 104 of the percutaneous medical device 102. For example, the introducer 204 may receive the deployment portion 104 until it is inserted into a patient's blood vessel. The delivery means 210 may include a cannula 220 having a cannula wall 222, and a fixing portion 224 positioned at the cannula wall 222. The cannula 220 may be configured to cover the deployment portion 104 of the percutaneous medical device 102 to be delivered together with the deployment portion 104 and to facilitate its movement through the delivery cavity 206 during delivery of the percutaneous medical device 102. Again, it should be noted that the example shown is only one of many examples. Additionally or alternatively, the delivery means 210 may include a tether assembly 230, which may optionally include first and second tethers 231, 232. Further details of the conveying device 210 and its components are discussed below.

[0058] As noted throughout the text, variations of the invention are conceivable. For example, although shown and discussed in relation to inlet 204, it is conceivable, and therefore not beyond the scope of the invention, that some examples of the delivery assembly 200 may exclude inlet 204 or may instead include members of different shapes or formed in different ways, functioning similarly to inlet 204. Similarly, although depicted as closed at both ends, sleeve 220 may have one open end and one closed end, or both open ends. These examples are merely some of those contemplated and that will be understood by those skilled in the art upon mastering the invention.

[0059] The resistance to insertion of the delivery device 210 through the delivery cavity 206 can be defined as the delivery force. The delivery force can be a function of the insertion depth, such that the delivery force is highest at initial insertion or shortly after insertion and lowest near delivery. As noted above, the percutaneous medical device 102 has a considerably resistive exterior within the membrane, resulting in a high delivery force. Conventional measures to reduce delivery force include lubricating and / or wetting one or more parts of the delivery assembly 200, such as the cannula 104, the inserter 204, or both. However, these measures can still result in undesirably high delivery forces. In the example, the cannula 220 can provide a lower delivery force than the percutaneous medical device 102. Similarly, the delivery force provided by the delivery device 210 can also be lower than, for example, the delivery force provided by conventional lubrication measures. In this respect, in some examples, the delivery force can be reduced by up to about 4 times, and in other examples, by orders of magnitude of about 3 times, 2.5 times, 2 times, 1.5 times, etc.

[0060] In the example, the cannula 220 is a constraint cannula 220. In this respect, the cannula 220 can be configured to constrain the deployment portion 104 such that the deployment portion 104 is constrained during delivery of the percutaneous medical device 102 and unconstrained once the deployment portion 104 has been deployed. The deployment portion 104 can be resilient to radial compression in a direction generally orthogonal to the outer surface of the cannula wall 222. In these cases, the deployment portion 104 can have a nominal diameter when at rest and a constrained diameter smaller than the nominal diameter when constrained. In some such examples, prior to delivery and deployment, the cannula 220 can be rolled up around a portion of the percutaneous medical device 102 (e.g., the deployment portion 104) to constrain the deployment portion 104 to a constraint diameter (e.g., in the delivery configuration of the circulatory support device 102). Just before deployment, the cannula 220 can be unrolled to allow the deployment portion 104 to return to its nominal diameter. In other words, the deployment portion 104 can be surrounded by the sleeve 220 and be within the constrained diameter until the deployment portion 104 is to be deployed, at which point the sleeve 220 can release the deployment portion 104 to return to the nominal diameter.

[0061] During setup, to move from the nominal diameter to the constrained diameter, the deployment portion 104 can be pulled into the cannula 220. For example, the deployment portion 104 can be positioned adjacent to a first end of the cannula 220. The deployment portion 104 can then be retracted into the cannula 220 by pulling a portion of the percutaneous medical device 102, thereby moving the deployment portion 104 relative to the cannula 220. As the portion of the deployment portion 104 enters the cannula 220, it can gradually move from the nominal diameter to the constrained diameter.

[0062] Release of the sleeve 220 from the deployment portion 104 (whether constrained or unconstrained) can be controlled via the fixing portion 224 of the sleeve 220. As previously noted, the sleeve 220 may include a sleeve wall 222 and a fixing portion 224 positioned at the sleeve wall 222. The fixing portion 224 can be actuated between a fixed state and an unconstrained state. The sleeve 220 can be configured to move radially between a constrained configuration (e.g., when the sleeve 220 is rolled up, as discussed above) and an expanded configuration (e.g., when the sleeve 220 is unfolded, as discussed above) via actuation of the fixing portion 224, such that the sleeve 220 is in the constrained configuration when the fixing portion 224 is in the fixed state and in the expanded configuration when the fixing portion 224 is in the unconstrained state.

[0063] A tether assembly 230 with a suitable construction can be used to facilitate the release of the sleeve 220 prior to subsequent deployment and removal. In this regard, the tether assembly 230 can be attached (e.g., fixedly or removably) to the sleeve 220 to engage it. In the example, the length of the tether assembly 230 can be longer than the length of the inlet 204, such that the gripping amount of the tether assembly 230 remains protruding from the proximal end 130 of the inlet 204 as the sleeve 210 is advanced through the inlet 204 and reaches the deployment site where the deployment portion 104 is deployed. The tether assembly 230 can be made of one or more materials, each having sufficient rigidity to withstand the delivery forces experienced by the sleeve 220, the deployment portion 104 inserted into (e.g., withdrawn into) the sleeve 220, and / or the gripping forces on the gripping amount. The gripping force can be the force required to deploy the sleeve 220. While in some cases the gripping force may be greater than the conveying force, in many cases the gripping force may be less than or equal to the conveying force. In some examples of the conveying device 210, the tether assembly 230 and the sleeve 220 may comprise the same material and / or may be manufactured as a single piece. In other examples, the sleeve 220 and the tether assembly 230 are separate components of the conveying device 210.

[0064] During operation, the tether assembly 230 can be configured to actuate the fixed portion 224 between a fixed state and an unfixed state. For example, the tether assembly 230 can actuate the fixed portion 224 from a fixed state during delivery of the percutaneous medical device 102 to an unfixed state prior to deployment of the deployment portion 104 of the percutaneous medical device 102. For example, as discussed in further detail below, the tether assembly 230 can be used to deploy the cannula 220 by pulling the tether assembly 230 in a proximal direction. In these cases, the radially outward force as the deployment portion 104 returns from the constrained diameter to the nominal diameter can assist in deploying the cannula 220.

[0065] Alternatively or alternatively, the tether assembly 230 may be configured to facilitate the withdrawal of the sleeve 220 to avoid covering the deployment portion 104 and / or withdrawing it from the delivery cavity 206. For example, pulling the tether assembly 230 in a proximal direction can cause a proportional movement of the sleeve 220. Initially, the sleeve 220 may be delivered while covering the deployment portion 104 (e.g., in a constrained configuration). When the sleeve 220 is in an expanded configuration just before the deployment portion 104 is deployed, a gripping force can be used to pull the tether assembly 230, thereby facilitating the proximal movement of the sleeve 220 so that it no longer covers the deployment portion 104. Then, alternatively or alternatively, a gripping force can be used to pull the tether assembly 230, thereby facilitating the withdrawal of the sleeve 220 from the delivery cavity 206.

[0066] While in some examples a single tether is used, in others the tether assembly 230 may include multiple tethers. For example, the multiple tethers may include a first tether and a second tether. The first tether may be configured to actuate the secured portion 224 from a secured state to an unsecured state. The second tether may be configured to facilitate the removal of the sleeve 220 from its expanded position to avoid obstructing the deployment portion, and to facilitate the removal of the sleeve 220 from the delivery cavity 206. In some examples, the first and second tethers 231, 232 may include different materials, each more suitable for its specific purpose. For example, the first tether may include a more rigid material than the second tether, or vice versa. In other examples, the first and second tethers may include substantially the same material.

[0067] Figure 3A , 3B Figures 4A and 4B show various examples of the fixing portion of the sleeve 220 according to various aspects of the invention. Figure 3A A first example of the sleeve 220 in a constrained configuration is shown, and Figure 3B A first example of the sleeve 220 in an expanded configuration is shown. Figure 4A A second example of the sleeve 220 in a constrained configuration is shown, and Figure 4B A second example of the sleeve 220 in an expanded configuration is shown.

[0068] In the first example, such as Figure 3A and 3B As shown, the fixing portion 224 may include one or more cords 240 interwoven with the tether in the tether assembly 230. In the example, the sleeve 220 includes a sheet having a first edge 226 and a second edge 228, and the fixing portion 224 includes removably fixing the first edge 226 and the second edge 228. In the example, removably fixing the first edge 226 to the second edge 228 includes fastening the first edge 226 and the second edge 228 together. In this way, one or more cords 240 can be braided from a portion of the sleeve 220 extending from the first edge 226 to form a first series of loops 242, and cords 240 (e.g., the same cord 240 or another cord 240) can be braided from a portion of the sleeve 220 extending from the second edge 228 to form a second series of loops 244. The tether can be strung together using the first series of loops 242 and the second series of loops 244. With this configuration, the tether assembly 230 can be configured, for example, to untie the first edge 226 and the second edge 228 by pulling the tether towards the proximal side, so as to release the first and second series loops 242, 244 from the tether.

[0069] like Figure 4A and 4BA second example of the fixing portion 224 shown may include a sleeve 220 comprising a film; and a fixing portion 224 comprising a divisible portion of the film. In the example, the film is a single continuous film having a first edge 226 and a second edge 228 such that the first edge 226 and the second edge 228 are opposite edges of the single continuous film. The divisible portion may include the first edge 226 and the second edge 228, and the tether assembly 230 may be configured to separate the first edge 226 from the second edge 228. In the example, the first edge 226 and the second edge 228 may overlap (e.g., one on top of the other or vice versa), and a tether in the tether assembly 230 may pass through the overlap to hold it in place until the tether is removed. When the tether is pulled (e.g., using a gripping force), the first edge 226 and the second edge 228 no longer maintain the overlap and separate one from the other to open (e.g., similar to removing a pin from a hinge and pin connection).

[0070] This invention includes a method for delivering a transdermal medical device. For example... Figure 5 As shown, such a method 500 may include, in step 502, surrounding the deployment portion of a percutaneous medical device with a cannula, such as the cannula discussed above. The cannula may include a cannula wall and a fixing portion positioned on the cannula wall, the fixing portion being actuable between a fixed state and an unfixed state. The cannula is configured to cover the deployment portion of the percutaneous medical device to facilitate its delivery with the deployment portion and to promote its movement through a delivery cavity during delivery of the percutaneous medical device. The cannula is also configured to move radially between a constrained form and an expanded form via actuation of the fixing portion, such that the cannula is in a constrained form when the fixing portion is in a fixed state and in an expanded form when the fixing portion is in an unfixed state. In step 504, the method 500 may include inserting the deployment portion of the percutaneous medical device, along with the cannula, into a body cavity, wherein the cannula is in a fixed state. At step 506, the method 500 may include changing the cannula from a fixed state to an unfixed state. At step 508, the method 500 may include withdrawing the cannula from the body cavity.

[0071] Examples of method 500 may include a multi-step insertion process. First, as discussed earlier, the deployment portion may be withdrawn into the cannula. In an example, method 500 may include inserting the percutaneous medical device together with the cannula into the introducer. In an example, inserting the deployment portion may include inserting the introducer into the body cavity and moving the deployment portion distally relative to the introducer such that the deployment portion is outside the introducer.

[0072] In the example, as previously noted, the cannula may include a tether assembly configured to switch the cannula from a fixed state to an unfixed state and to withdraw the cannula from the body cavity. In the example, a first tether of the tether assembly may be configured to switch the cannula from a fixed state to an unfixed state; and a second tether of the tether assembly may be configured to withdraw the cannula from the body cavity.

[0073] It should be understood that the method including one or more steps and the order in which they are listed are not limitations on the claims unless expressly or implicitly stated otherwise in the specification or its claims. It is also understood that the methods described are merely some examples among the many disclosed examples, and certain steps may be added or omitted without departing from the scope of the invention. These steps may include those incorporated into an apparatus, system, or method or components thereof, as well as those recognized, conventional, and traditional in the art.

[0074] The connecting lines shown in the various figures contained herein are intended to illustrate exemplary functional relationships and / or physical connections between various elements. It should be noted that many alternative or additional functional relationships or physical connections may exist in a real system. However, any benefit, advantage, solution to a problem, and any element that may cause any benefit, advantage, or solution to occur or become more apparent should not be construed as a critical, essential, or necessary feature or element. Therefore, its scope is limited only by the appended claims, where reference to an element in the singular is not intended to mean "one and only one," but rather "one or more" unless explicitly stated otherwise. Furthermore, when phrases like "at least one of A, B, or C" are used in the claims, it is intended that such phrases be interpreted as: A exists alone in one embodiment, B exists alone in one embodiment, C exists alone in one embodiment, or any combination of elements A, B, or C may exist in a single embodiment; for example, A and B, A and C, B and C, or A and B and C.

[0075] In the detailed description herein, references to "an embodiment," "an example embodiment," "an exemplary embodiment," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic; however, each embodiment may not necessarily include that particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Moreover, when a particular feature, structure, or characteristic is described in conjunction with embodiments, it is believed that the advantages of the invention in affecting such feature, structure, or characteristic in conjunction with other embodiments are within the knowledge of those skilled in the art, whether explicitly described or not. After reading the description, it will be apparent to those skilled in the art how the invention can be implemented in alternative embodiments.

[0076] Furthermore, the elements, components, or method steps in this invention are not intended to be exclusive to the public, regardless of whether they are expressly referred to in the claims. Elements of the claims herein shall not be construed in accordance with 35 U.S.SC 112(f) unless the element is expressly described using the phrase “means for…”. As used herein, the terms “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that includes a list of elements includes not only those elements but may include other elements not expressly listed or inherent to such process, method, article, or apparatus.

[0077] While the invention has been described with exemplary design, further modifications are possible within its spirit and scope. Therefore, this application is intended to cover any variations, uses, or adaptations of the invention using its general principles. Furthermore, this application is intended to cover such deviations from the invention in known or customary practices within the field to which this invention pertains.

Claims

1. A conveying device for a circulating support device, the conveying device comprising: A sleeve, comprising a sleeve wall and a fixed portion, the fixed portion being positioned at the sleeve wall and actuable between a fixed state and an unfixed state, the sleeve being configured to cover a deployment portion of the circulatory support device for transporting together with the deployment portion and facilitating its movement through a transport cavity during transport of the circulatory support device, the sleeve being further configured to radially move between a constrained form and an expanded form via actuation of the fixed portion, such that the sleeve is in the constrained form when the fixed portion is in the fixed state and in the expanded form when the fixed portion is in the unfixed state; as well as A tethering assembly engages the sleeve and is configured to actuate the fixing portion between a fixed state when the circulation support device is being conveyed and an unfixed state before the deployment portion of the circulation support device is deployed. The tethering assembly is also configured to facilitate the withdrawal of the sleeve from covering the deployment portion when the sleeve is in the expanded configuration, and to facilitate the withdrawal of the sleeve from the delivery cavity. The fixing part includes one or more thin ropes intertwined with the ropes in the rope assembly to form multiple loops, and the ropes are strung through the multiple loops.

2. The conveying device of claim 1, wherein the sleeve is a constraint sleeve configured to constrain the deployment portion such that the deployment portion is constrained when the cyclic support device is conveyed and is unconstrained when the deployment portion has been deployed.

3. The conveying device of claim 1, wherein the tether assembly comprises a plurality of tethers, including a first tether and a second tether, wherein the first tether is configured to actuate the fixed portion from the fixed state to the unfixed state, and wherein the second tether is configured to facilitate the extraction of the sleeve from covering the deployment portion when the sleeve is in the expanded form, and to facilitate the extraction of the sleeve from the conveying cavity.

4. The conveying device of claim 1, wherein the sleeve comprises a sheet having a first edge and a second edge; wherein the fixing portion comprises removably fixing the first edge and the second edge; wherein removably fixing the first edge to the second edge comprises tying the first edge and the second edge together; and wherein the tether assembly is configured to untie the first edge and the second edge.

5. The conveying device according to claim 1, wherein the conveying force provided by the sleeve is lower than the conveying force of the circulating support device.

6. The delivery device according to any one of claims 1 to 5, wherein the circulatory support device includes a ventricular assist device configured to pump blood from the left ventricle of the subject into the subject's aorta.

7. The conveying device according to any one of claims 1 to 5, wherein in the constrained configuration, the sleeve is wound around the deployment portion, and in the expanded configuration, the sleeve is unfolded.

8. A conveying assembly comprising: The conveying device according to claim 1; as well as An inlet is configured to removably accommodate the deployment portion of the cyclic support device within the delivery cavity of the inlet.

9. The delivery assembly of claim 8, wherein the sleeve is a constraint sleeve configured to constrain the deployment portion such that the deployment portion is constrained when the cyclic support device is delivered and unconstrained when the deployment portion has been deployed.

10. The delivery assembly of claim 8, wherein the tether assembly comprises a plurality of tethers, the plurality of tethers including a first tether and a second tether, wherein the first tether is configured to actuate the fixed portion from the fixed state to the unfixed state, and wherein the second tether is configured to facilitate the withdrawal of the sleeve from covering the deployment portion when the sleeve is in the expanded configuration, and to facilitate the withdrawal of the sleeve from the delivery cavity.

11. The delivery assembly of claim 8, wherein the sleeve comprises a sheet having a first edge and a second edge; wherein the fixing portion comprises removably fixing the first edge and the second edge; wherein removably fixing the first edge to the second edge comprises tying the first edge and the second edge together; and wherein the tether assembly is configured to untie the first edge and the second edge.

12. The conveying assembly according to any one of claims 8 to 11, wherein the conveying force provided by the sleeve is lower than the conveying force of the circulating support device.

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