Device for promoting delivery of a device with high-friction braid

Abstract

A delivery device for a transcutaneous medical device is disclosed herein. The delivery device includes a sheath member including a sheath wall, a sheath orifice formed at the sheath wall such that the sheath member is configured to receive a deployment portion of the transcutaneous medical device through the sheath orifice, and a tether assembly extending from the sheath wall; the sheath member is configured to removably cover the deployment portion; the tether assembly is configured to facilitate removal of the sheath member from covering the deployment portion and to facilitate extraction of the sheath member from a delivery lumen.

Description

Technical Field

[0001] This disclosure relates to delivery aids for percutaneous circulatory support devices. More specifically, this disclosure relates to delivery aids for integrated braided cannulas in circulatory support pumps. Background Technology

[0002] Circulatory support devices support the heart's pumping action. These devices can be positioned through valvular openings, such as, for example, the aortic valve. Typically, circulatory support devices have a polymer coating that, for example, protects the underlying components, such as the mesh of the circulatory support device. However, such a coating can make it difficult for the circulatory support device to travel through the lumen used to deliver such a device to the treatment site. Summary of the Invention

[0003] In Example 1, a delivery device for a percutaneous medical device includes: an occlusive member and a tethering assembly. The occlusive member includes an occlusive wall and an occlusive orifice formed in the occlusive wall such that the occlusive member is configured to receive a deployment portion of the percutaneous medical device through the occlusive orifice. The tethering assembly extends from the occlusive wall. The occlusive member is configured to removably cover the deployment portion with the occlusive wall. The tethering assembly is configured to facilitate removal of the occlusive member from the covered deployment portion and to facilitate extraction of the occlusive member from the delivery lumen.

[0004] In Example 2, the delivery device according to Example 1 is provided, wherein the tethering assembly is fixedly connected to the envelope member.

[0005] In Example 3, according to the delivery device described in Example 1 or 2, the tethering assembly includes a collar that connects the tethering assembly to the occlusal member; wherein the collar is optionally configured to inhibit movement of the occlusal member relative to the percutaneous medical device.

[0006] In Example 4, the delivery device according to any one of Examples 1 to 3, wherein the distal portion of the envelope member includes a fixing member configured to inhibit expansion of the distal portion of the envelope member when the fixing member is fixed and to allow expansion of the distal portion of the envelope member when the fixing member is released; and wherein the fixing member optionally includes silicone.

[0007] In Example 5, the delivery device according to any one of Examples 1 to 4, wherein the envelope member is a woven mesh envelope member; and wherein the envelope member optionally includes nitinol.

[0008] In Example 6, a delivery assembly for a percutaneous medical device includes a delivery tube and a delivery device. The delivery tube has an inner lumen configured to removably receive a deployment portion of the percutaneous medical device. The delivery device includes an occlusal member and a tethering assembly. The occlusal member includes an occlusal wall and an occlusal orifice formed in the occlusal wall such that the occlusal member is configured to receive the deployment portion of the percutaneous medical device through the occlusal orifice. The tethering assembly extends from the occlusal wall. The occlusal member is configured to removably cover the deployment portion with the occlusal wall. The tethering assembly is configured to facilitate withdrawal of the occlusal member from the covered deployment portion and from the delivery lumen.

[0009] In Example 7, the delivery assembly according to Example 6 is provided, wherein the tethering assembly is fixedly connected to the envelope member.

[0010] In Example 8, the delivery assembly according to Example 6 or 7, wherein the tethering assembly includes a collar that connects the tethering assembly to the occlusal member at the proximal end of the occlusal member; and wherein the collar is optionally configured to inhibit movement of the occlusal member relative to the percutaneous medical device.

[0011] In Example 9, the delivery assembly according to one of Examples 6 to 8, wherein the distal portion of the envelope member includes a fixing member configured to inhibit expansion of the distal portion of the envelope member when the fixing member is fixed, and to allow expansion of the distal portion of the envelope member when the fixing member is released.

[0012] In Example 10, the delivery assembly according to one of Examples 6 to 9 is wherein the envelope member is a woven mesh envelope member; and wherein the fixing member optionally includes silicone.

[0013] In Example 11, the delivery assembly is according to one of Examples 6 to 10, wherein the envelope component comprises nitinol.

[0014] In Example 12, a method of delivering a percutaneous medical device includes surrounding a deployment portion of the percutaneous medical device with a delivery device, the delivery device including: an occlusal member and a tethering assembly, the occlusal member including an occlusal wall, an occlusal orifice formed in the occlusal wall such that the occlusal member is configured to receive the deployment portion of the percutaneous medical device through the occlusal orifice, the occlusal member being configured to removably cover the deployment portion with the occlusal wall, the tethering assembly being configured to facilitate withdrawal of the occlusal member from the covered deployment portion and from a delivery lumen; inserting the deployment portion together with the occlusal member into a body cavity; and withdrawing the occlusal member from the body cavity.

[0015] In Example 13, the method according to Example 12 further includes withdrawing the deployment portion together with the envelope member into the delivery tube, and wherein inserting the deployment portion includes inserting the delivery tube into the body cavity and moving the deployment portion distally relative to the delivery tube such that the deployment portion is outside the delivery tube.

[0016] In Example 14, according to the method of Example 12 or 13, the distal portion of the envelope member includes a fixing member configured to inhibit expansion of the distal portion of the envelope member when the fixing member is fixed and to allow expansion of the distal portion of the envelope member when the fixing member is released, and wherein the tethering assembly is configured to transfer the fixing member from a fixed state to an unfixed state, wherein inserting the deployment portion together with the envelope member into the body cavity occurs when the envelope member is in a fixed state, and wherein the method further includes transferring a portion of the envelope member from a fixed state to an unfixed state.

[0017] In Example 15, according to one of Examples 12 to 14, the tethering assembly includes a collar that connects the tethering assembly to the sleeve member at the proximal end of the sleeve member, and wherein the sleeve opening is positioned distally relative to the collar.

[0018] In Example 16, a delivery device for a percutaneous medical device includes: an occlusive member and a tethering assembly, the occlusive member including an occlusive wall and an occlusive orifice formed therein such that the occlusive member is configured to receive a deployment portion of the percutaneous medical device through the occlusive orifice, the tethering assembly extending from the occlusive wall; the occlusive member being configured to removably cover the deployment portion with the occlusive wall; and the tethering assembly being configured to facilitate removal of the occlusive member from the covered deployment portion and to facilitate extraction of the occlusive member from the delivery lumen.

[0019] In Example 17, the delivery device according to Example 16 is provided, wherein the tethering assembly is fixedly connected to the envelope member.

[0020] In Example 18, the delivery device according to Example 16 includes a tethering assembly that connects the tethering assembly to the sealing member.

[0021] In Example 19, according to the delivery device of Example 18, the collar is configured to inhibit movement of the suffix member relative to the percutaneous medical device.

[0022] In Example 20, the delivery device according to Example 16, wherein the distal portion of the envelope member includes a fixing member configured to suppress expansion of the distal portion of the envelope member when the fixing member is fixed, and to allow expansion of the distal portion of the envelope member when the fixing member is released.

[0023] In Example 21, the delivery device according to Example 20 is wherein the envelope component is a woven mesh envelope component.

[0024] In Example 22, the delivery device according to Example 21 is provided, wherein the fixing member comprises silicone.

[0025] In Example 23, the delivery device according to Example 16 is provided, wherein the envelope component comprises nitinol.

[0026] In Example 24, a delivery assembly for a percutaneous medical device includes a delivery tube and a delivery device. The delivery tube has an inner lumen configured to removably receive a deployment portion of the percutaneous medical device. The delivery device includes an occlusal member and a tethering assembly. The occlusal member includes an occlusal wall and an occlusal orifice formed in the occlusal wall such that the occlusal member is configured to receive the deployment portion of the percutaneous medical device through the occlusal orifice. The tethering assembly extends from the occlusal wall. The occlusal member is configured to removably cover the deployment portion with the occlusal wall. The tethering assembly is configured to facilitate removal of the occlusal member from the covered deployment portion and from the delivery lumen.

[0027] In Example 25, the delivery assembly according to Example 24 is provided, wherein the tethering assembly is fixedly connected to the envelope member.

[0028] In Example 26, the delivery assembly according to Example 24 is provided, wherein the tethering assembly includes a collar that connects the tethering assembly to the sleeve member at the proximal end of the sleeve member.

[0029] In Example 27, the delivery assembly according to Example 26 is provided, wherein the collar is configured to inhibit movement of the clasp member relative to the percutaneous medical device.

[0030] In Example 28, the delivery assembly according to Example 24, wherein the distal portion of the envelope member includes a fixing member configured to suppress expansion of the distal portion of the envelope member when the fixing member is fixed, and to allow expansion of the distal portion of the envelope member when the fixing member is released.

[0031] In Example 29, the delivery assembly according to Example 28 is used, wherein the envelope component is a woven mesh envelope component.

[0032] In Example 30, the delivery assembly according to Example 29 is provided, wherein the fixing member comprises silicone.

[0033] In Example 31, the delivery assembly according to Example 24 is provided, wherein the envelope component comprises nitinol.

[0034] In Example 32, the method of delivering a percutaneous medical device includes surrounding a deployment portion of the percutaneous medical device with a delivery device, the delivery device including: an occlusal member and a tethering assembly, the occlusal member including an occlusal wall, an occlusal orifice formed in the occlusal wall such that the occlusal member is configured to receive the deployment portion of the percutaneous medical device through the occlusal orifice, the occlusal member being configured to removably cover the deployment portion with the occlusal wall, the tethering assembly being configured to facilitate withdrawal of the occlusal member from the covered deployment portion and from a delivery lumen; inserting the deployment portion together with the occlusal member into a body cavity; and withdrawing the occlusal member from the body cavity.

[0035] In Example 33, the method according to Example 32 further includes withdrawing the deployment portion together with the envelope member into the delivery tube, and wherein inserting the deployment portion includes inserting the delivery tube into the body cavity and moving the deployment portion distally relative to the delivery tube such that the deployment portion is outside the delivery tube.

[0036] In Example 34, according to the method of Examples 32, the distal portion of the envelope member includes a fixing member configured to inhibit expansion of the distal portion of the envelope member when the fixing member is fixed and to allow expansion of the distal portion of the envelope member when the fixing member is released, and the tethering assembly is configured to transfer the fixing member from a fixed state to an unfixed state, wherein the insertion of the deployment portion together with the envelope member into the body cavity occurs when the envelope member is in a fixed state, and wherein the method further includes transferring a portion of the envelope member from a fixed state to an unfixed state.

[0037] In Example 35, according to the method of Example 34, the tethering assembly includes a collar that connects the tethering assembly to the sleeve member at the proximal end of the sleeve member, and wherein the sleeve orifice is positioned distally relative to the collar.

[0038] 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 exemplary embodiments of the invention. Therefore, the drawings and detailed description should be considered illustrative and non-limiting. Attached Figure Description

[0039] Figure 1A A conceptual diagram of a circulatory support device according to some aspects of this disclosure is shown, the circulatory support device including a cannula and an adapter.

[0040] Figure 1B This disclosure illustrates some aspects of the present disclosure. Figure 1A Side view of a circulation support device, which includes a pump.

[0041] Figure 2A side view of the delivery component according to some aspects of this disclosure is shown.

[0042] Figure 3A Enclosure components according to some aspects of this disclosure are shown.

[0043] Figure 3B This disclosure illustrates some aspects of the present disclosure. Figure 3A The envelope component located around the deployment section.

[0044] Figure 3C A second example of a cover member 220 according to some aspects of this disclosure is shown.

[0045] Figure 4 A flowchart of a method according to some aspects of this disclosure is shown.

[0046] Although the invention can be modified in various ways and alternatives, specific embodiments have been shown by way of example in the accompanying drawings and described in detail below. However, the invention is not limited to the specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives that fall within the scope of the invention, as defined by the appended claims. Detailed Implementation

[0047] This invention relates to a cyclic support device having a reduced delivery force compared to conventional embodiments. For the purpose of facilitating an understanding of the principles of this disclosure, reference is now made to the examples shown in the accompanying drawings, which are described below. The examples shown herein are not intended to be exhaustive or to limit this disclosure to the precise forms disclosed in the detailed descriptions below. Rather, these exemplary embodiments are selected and described to enable those skilled in the art to utilize their teachings. Multiple (e.g., all) features in a given example used in all examples do not exceed the scope of this disclosure. Therefore, a figure should not be construed as having any dependency or requirement relating to any single component or combination of components shown herein. Furthermore, in the examples, various components shown in a given figure may be integrated with multiple (and / or components not shown) of other components shown herein, all of which should be considered within the scope of this disclosure.

[0048] Figure 1A A conceptual diagram of a circulatory support device 102 is shown according to an embodiment of the subject matter disclosed herein. The circulatory support device 102 includes a cannula 104 and an adapter 108. The circulatory support device 102 is shown disposed within the heart 110. According to an embodiment, the circulatory support device 102 may include a ventricular assist device (VAM). Figure 1B(As shown), such as a pump, which 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 to the subject's aorta 114. In embodiments, the circulatory support device 102 can be used to treat cardiogenic shock and other heart failure conditions.

[0049] In one embodiment, the distal portion 116 of the circulatory support device 102 is disposed in 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, and the adapter 108 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 of the circulatory support device 102, and releases it into the aorta 114. Additionally or alternatively, the circulatory support device 102 may be used to facilitate the pumping of blood from other aspects of the subject's vascular system to adjacent portions of the vascular system.

[0050] Figure 1B Embodiments based on the subject matter disclosed herein are shown. Figure 1A The side view of the circulatory support device 102 shown includes a ventricular assist device 103.

[0051] 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 embodiments, 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 embodiments, 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 can expand to its larger diameter. By expanding to a diameter larger than its delivery configuration, cannula 104 can provide a higher flow rate than a non-expandable, smaller-diameter cannula 104. In an embodiment, the braided mesh 124 may be designed to adequately withstand the pressure gradient between the inner and outer sides of cannula 104.

[0052] In one embodiment, the braided mesh 124 is coated with a film to form a conduit extending from the distal portion 116 to the proximal portion 122 through the cannula 104. In another embodiment, the film may be silicone. In another embodiment, the cannula 104 is formed from a plurality of nitinol wires having a diameter of 0.008”. However, this is merely an example, and other types of wires with other diameters may be used to form the cannula 104. Additionally 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 number of nitinol wires (e.g., 6 to 48 wires). Although protective, the film coated on the braided mesh 124 can have considerable external resistance, which has proven 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 lumen 206 during setup and / or operation.

[0053] Turn Figure 2 The diagram 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 shown from right to left in the diagram, and the distal direction is shown from left to right. Furthermore, in the following text, for the sake of simplicity, the percutaneous medical device 102 will be collectively referred to as 102, and the deployment portion 104 will be collectively referred to as 104. However, it should be noted that the use of delivery assemblies 200 having other percutaneous medical devices 102 and their deployment portions 104 is also contemplated and therefore does not exceed the scope of this disclosure.

[0054] Considering the resistant properties of the membrane, the delivery assembly 200 may include a guide 204, a delivery lumen 206 formed in the guide 204, and a delivery device 210 for assisting in the delivery of the percutaneous medical device 102. The delivery lumen 206 may be configured to removably receive the deployment portion 104 of the percutaneous medical device 102. For example, the guide 204 may receive the deployment portion 104 until it is inserted into the patient's vascular system. In some instances, the delivery lumen 206 is configured to restrain the deployment portion 104 or a combination of the deployment portion 104 and the delivery device 210 (e.g., by having a smaller diameter). In other instances, the delivery lumen 206 does not restrain the deployment portion 104 or a combination of the deployment portion 104 and the delivery device 210. The delivery device 210 may include an enveloping member 220 and a tethering assembly 230. The enveloping member 220 may be configured to removably cover the deployment portion 104 with an enveloping wall 222. The tethering assembly 230 can be configured to facilitate the removal of the sheath member 220 from the state of the covered deployment portion 104 and to facilitate the removal of the sheath member 220 from the delivery lumen 206.

[0055] As noted throughout, variations of this disclosure are contemplated. For example, while shown and discussed herein as including guide 204, some instances of delivery assembly 200 may exclude guide 204 or alternatively include differently shaped or formed members that function similarly to guide 204, and thus do not exceed the scope of this disclosure. Additionally, although shown closed at both ends, envelope member 220 may have one open end and one closed end, or two open ends. Even these examples are merely some that may be contemplated by those skilled in the art and will be understood in understanding this disclosure.

[0056] The resistance to insertion of the delivery device 210 into the delivery lumen 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 or shortly thereafter during initial insertion and lowest near delivery. As noted above, the percutaneous medical device 102 has considerable external resistance within the membrane, resulting in a high delivery force. Conventional measures to reduce the delivery force include lubricating and / or wetting one or more portions of the delivery assembly 200, such as the cannula 104, guide 204, or both. However, these measures can still result in an undesirable, relatively high delivery force. In some embodiments, the sheath member 220 can provide a lower delivery force than the percutaneous medical device 102. Additionally, the delivery force provided by the delivery device 210 can be lower than, for example, conventional lubrication measures. In this regard, the delivery force can be reduced by up to approximately 4 times in some embodiments, and by approximately 3 times, 2.5 times, 2 times, 1.5 times, etc., in other embodiments.

[0057] When positioned around a portion of the deployment portion 104, the sheath member 220 reduces the delivery force required to deliver the deployment portion 104 through the delivery lumen 206. The sheath member 220 may include a sheath wall 222, a sheath orifice 223 formed on the sheath wall 222, and a tethering assembly 230 extending from the sheath wall 222, the sheath orifice 223 being formed such that the sheath member 220 is configured to receive the deployment portion 104 of the percutaneous medical device 102 through the sheath orifice 223. During setup, the deployment portion 104 may be received in the sheath orifice 223 (e.g., at a distal, proximal, or intermediate location) such that a portion (e.g., all) of the deployment portion 104 is located within the sheath member 220. This configuration allows the deployment portion 104, together with the sheath member 220, to be inserted into the delivery lumen 206 with reduced delivery force. In these cases, the sheath member 220 may be adapted to the deployment portion 104 and the delivery lumen 206. As discussed further below, in one example, the tethering assembly 230 may be used to withdraw the sheath member 220 from the delivery lumen 206 only prior to deployment of the deployment portion 104 (e.g., by proximal movement via the tethering assembly 230). In these cases, the sheath member 220 is moved from covering or surrounding a portion of the deployment portion 104 to be withdrawn (e.g., by distal movement relative to the deployment portion 104) to expose the deployment portion 104.

[0058] Figure 3A and Figure 3B Various views of the delivery apparatus 210 according to some aspects of this disclosure are shown. Figure 3A A first example of envelope component 220 is shown. Figure 3B It shows Figure 3A Enclosure component 220 is located around deployment section 104. Figure 3C A second example of the envelope component 220 is shown.

[0059] In examples, as illustrated in these figures herein, the envelope member 220 is a braided mesh envelope member 220 made of a generally flexible material. In examples, the envelope member 220 includes nitinol (e.g., multiple nitinol strands) or other similar material surrounding an internal space, which may be large enough to accommodate the deployment portion 104. In this regard, the braided mesh envelope member 220 may be a deformable flexible structure such that manipulating one part of the braided mesh envelope member 220 manipulates another part of the braided mesh envelope member 220. As an example, the braided mesh envelope member 220 may initially be a generally tubular structure with opposing ends, and manipulated at the opposing ends such that the diameter of the braided mesh envelope member 220 decreases at the opposing ends while the diameter of the middle portion increases. In these cases, the shape of the longitudinal cross-section of the braided mesh envelope member 220 (e.g., truncated along the proximal and distal directions) may be generally elliptical. As a result, the braided mesh sheath member 220 fits relatively loosely onto the deployment portion 104, but not so loosely that, for example, no tightening occurs during the insertion of the braided mesh sheath member 220 together with the deployment portion 104 into the delivery lumen 206. Other types of cross-sections (e.g., eccentric, symmetrical, etc.), corresponding manipulations, and corresponding fits on the deployment portion 104 (e.g., binding fits) are contemplated and should not be considered beyond the scope of the invention.

[0060] The elastic portion secures the braided mesh envelope member 220 to the deployment portion 104. In one example, the distal portion of the envelope member 220 may include a retaining member 224 configured to inhibit expansion of the distal portion of the envelope member 220 when the retaining member 224 is secured, and to allow expansion of the distal portion of the envelope member 220 when the retaining member 224 is released. In one example, the retaining member 224 may include silicone or a similar material. In this regard, the retaining member 224 may be an elastic portion of the braided mesh envelope member 220 and may have a level of elasticity (e.g., radial elasticity) that withstands delivery forces to prevent unintentional expansion of the envelope member 220, thereby preventing premature release of the deployment portion 104 from the envelope member 220.

[0061] The delivery device 210 is constructed to accommodate various forces (e.g., delivery force and gripping force) experienced by the delivery device 210 during operation. In one example, the length of the tethering assembly 230 may be longer than the length of the guide 204, such that as the envelope member 220 is advanced through the guide 204 to the deployment site where the deployment portion 104 is deployed, the gripping amount of the tethering assembly 230 still extends from the proximal end of the guide 204. The tethering assembly 230 may be made of one or more materials, each of which is sufficiently rigid to withstand the delivery force and / or gripping force of the gripping amount experienced by the envelope member 220 when the deployment portion 104 is inserted (e.g., withdrawn) into the envelope member 220. The gripping force may be the force required to extend the retaining member 224. While in some cases the gripping force may be greater than the delivery force, in many cases the gripping force may be less than or equal to the delivery force.

[0062] In this example, the tethering assembly 230 may be integrally manufactured with the envelope member 220 or may be a separate component attached to the envelope member 220. When it is a separate component of the envelope member 220, the tethering assembly 230 may be attached to the envelope member 220 in various ways (e.g., fixedly or rigidly). Figure 3A and Figure 3B As seen in the first example, the tethering assembly 230 may include a collar 350 that connects the tethering assembly 230 to the sheath member 220 (e.g., along the sheath wall 222 or at a distal or proximal portion of the sheath member 220). This connection may be relatively rigid or semi-rigid. In this example, the collar 350 may be configured to inhibit movement of the sheath member 220 relative to the percutaneous medical device 102. For example, the deployment portion 104 (or an adjacent portion at the distal end of the catheter where the deployment portion 104 is located) may have a first diameter, and the collar 350 may have a second diameter smaller than that first diameter. Figure 3C As seen in the second example, the tethering assembly 230 can be connected to the sheath member 220 via an adhesive cap 360, which optionally separates the sheath member to one side, such that the sheath member tapers from its distal portion to its proximal portion. It should be noted that the adhesive cap 360 can optionally be disposed on the distal portion of the sheath member, so that a non-invasive adhesive cap is included at either end. The connection between the sheath member 220 and the tethering assembly 230 is configured (e.g., as...) Figures 3A to 3C In the case shown, the travel of the envelope member past the proximal end of the deployment portion 104 can be suppressed. In these cases, movement of the envelope member 220 relative to the deployment portion 104 can be temporarily suppressed (e.g., until a gripping force is applied to the tethering assembly 230).

[0063] During operation, the tethering assembly 230 can be configured to actuate the fixation member 224 between a fixed state and an unfixed state. For example, the tethering assembly 230 can actuate the fixation member 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 tethering assembly 230 can cause the fixation member 224 to expand by pulling the tethering assembly 230 in the proximal direction. In this regard, the fixation member 224 may be abutted against the deployment portion 104. In these cases, a radially outward force as the fixation member 224 gradually moves along a portion of the deployment portion 104 can assist in expanding the fixation member 224.

[0064] Additionally or alternatively, the tethering assembly 230 may be configured to facilitate the removal of the sheath member 220 from the state covering the deployment portion 104 and / or from the delivery lumen 206. For example, pulling the tethering assembly 230 in the proximal direction can proportionally move the sheath member 220. Initially, the sheath member 220 may be delivered in the state covering the deployment portion 104 (e.g., in a constrained configuration). When the sheath member 220 is in an extended configuration before deployment of the deployment portion 104, the tethering assembly 230 may be pulled using a gripping force, thereby facilitating proximal movement of the sheath member 220 so that it no longer covers the deployment portion 104. Then, additionally or alternatively, the tethering assembly 230 may be pulled using a gripping force, thereby facilitating the removal of the sheath member 220 from the delivery lumen 206.

[0065] While a single tether is used in some instances, the tether assembly 230 may include multiple tethers in other instances. For example, the multiple tethers may include a first tether and a second tether. The first tether may be configured to actuate the fixing member 224 from a fixed state to an unfixed state. The second tether may be configured to facilitate the withdrawal of the sleeve member 220 from the state of the covered deployment portion 104 and to facilitate the withdrawal of the sleeve member 220 from the delivery lumen 206. In some instances, the first tether 231 and the second tether 232 may include different materials, each better suited to its specific purpose. For example, the first tether may include a more rigid material than the second tether, and vice versa. In other instances, the first tether and the second tether may comprise substantially the same material.

[0066] This disclosure includes methods for delivering percutaneous medical devices. For example... Figure 4As shown, such a method 400 may include, in step 402, surrounding the deployment portion of a percutaneous medical device with a delivery device. This delivery device may be similar to those disclosed elsewhere herein, including delivery device 210. For example, the delivery device may include an occlusal member and a tethering assembly. The occlusal member may include an occlusal wall and an occlusal orifice formed at the occlusal wall such that the occlusal member is configured to receive the deployment portion of the percutaneous medical device through the occlusal orifice. The tethering assembly may extend from the occlusal wall. The occlusal member may be configured to removably cover the deployment portion with the occlusal wall. The tethering assembly may be configured to facilitate withdrawal of the occlusal member from the state covering the deployment portion and to facilitate withdrawal of the occlusal member from the delivery lumen. Method 400 may include, in step 404, inserting the deployment portion together with the occlusal member into a body cavity. Method 400 may include, in step 406, withdrawing the occlusal member from the body cavity.

[0067] Examples of method 400 may include a multi-step insertion process. In one example, method 400 may include withdrawing the deployment portion together with the envelope member into a delivery tube. In another example, inserting the deployment portion may include inserting the delivery tube into a body cavity and moving the deployment portion distally relative to the delivery tube such that the deployment portion is outside the delivery tube.

[0068] In an example, as noted above, the distal portion of the envelope member may include a fixation member configured to inhibit expansion of the distal portion of the envelope member when the fixation member is secured, and to allow expansion of the distal portion of the envelope member when the fixation member is released. The tethering assembly may be configured to transfer the fixation member from a secured state to an unsecured state. Inserting the deployment portion together with the envelope member into the body cavity may occur when the envelope member is in a secured state. Method 400 may include transferring a portion of the envelope member from a secured state to an unsecured state.

[0069] In an example, as noted above, the tethering assembly may include a collar that connects the tethering assembly to the sleeve member at the proximal end of the sleeve member. The sleeve orifice may be positioned distally relative to the collar.

[0070] It is understood that methods comprising one or more steps are not limited by the order listed in the claims unless there is an explicit or implied statement to the contrary in the specification or the claims themselves. It is also clear that the methods shown are merely some examples of the many disclosed instances, and certain steps may be added or omitted without departing from the scope of this disclosure. Such steps may include components incorporated into an apparatus, system, or method, or components thereof, as well as components known, conventional, and conventional in the art.

[0071] The connecting lines shown in the various figures contained herein are intended to represent 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 actual systems. However, benefits, advantages, problem solutions, and any element that causes any benefit, advantage, or solution to appear or become more apparent should not be construed as critical, essential, or fundamental features or elements. Therefore, the scope should not be limited except in the appended claims, where references to singular elements are not intended to mean “one and only one” unless expressly stated so, but rather to mean “one or more.” Furthermore, where phrases such as “at least one of A, B, or C” are used in the claims, it is intended that such phrases should be interpreted as meaning that: A may exist alone in one embodiment, B may exist alone in one embodiment, C may exist 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.

[0072] In the specific implementation herein, references to "an embodiment," "an embodiment," "example embodiment," etc., indicate that the described embodiment may include a particular feature, structure, or characteristic, but not every embodiment needs to include that particular feature, structure, or characteristic. Furthermore, such phrases do not necessarily refer to the same embodiment. Additionally, when a particular feature, structure, or characteristic is described in conjunction with an embodiment, it is claimed that, whether explicitly described or not, those skilled in the art will understand that the benefits of this disclosure affect such feature, structure, or characteristic in combination with other embodiments. After reading this specification, it will be apparent to those skilled in the art how this disclosure can be implemented in alternative embodiments.

[0073] Furthermore, none of the elements, components, or method steps disclosed herein are intended for public disclosure, whether or not they are expressly stated in the claims. The elements of the claims herein are not to be interpreted in accordance with 35 U.S.SC 112(f) unless expressly stated using the phrase “means for”. As used herein, the terms “comprising,” “including,” or any other variations thereof are intended to cover a non-exclusive inclusion, such that a process, method, article of manufacture, or apparatus that includes a list of elements may include not only those elements but also other elements not expressly listed or inherent to such process, method, article of manufacture, or apparatus.

[0074] While this disclosure has been described with exemplary designs, the invention may be further modified within the spirit and scope of this disclosure. Therefore, this application is intended to cover any variations, uses, or modifications of the invention utilizing its general principles. Furthermore, this application is intended to cover such deviations from the content of this disclosure in known or customary practice in the field to which this invention pertains.

[0075] Various modifications and additions may be made to the exemplary embodiments discussed without departing from the scope of the invention. For example, while the embodiments described above refer to specific features, the scope of the invention also includes embodiments with different combinations of features and embodiments that do not include all described features. Therefore, the scope of the invention is intended to cover all such alternatives, modifications, and variations that fall within the scope of the claims, as well as all their equivalents.

Claims

1. A system for delivering a transdermal medical device, the system comprising: A circulation support pump with expandable cannula; A sleeve member having a sleeve wall, the sleeve member being configured to removably cover the expandable cannula to hold the expandable cannula in a constrained configuration, wherein the diameter of the middle portion of the sleeve member is greater than the diameter of the proximal end and the distal end of the sleeve member; and A tethering assembly extending from the envelope wall; The tethering assembly is configured to facilitate removal of the sheath member from the cover of the expandable cannula and to facilitate extraction of the sheath member from the delivery lumen.

2. The system of claim 1, wherein the tethering assembly is fixedly connected to the sleeve member.

3. The system of claim 1, wherein the tethering assembly includes a collar connecting the tethering assembly to the occlusal member, wherein the collar is configured to inhibit movement of the occlusal member relative to the percutaneous medical device.

4. The system of claim 1, wherein the distal portion of the envelope member includes a fixing member configured to inhibit expansion of the distal portion of the envelope member when the fixing member is fixed, and to allow expansion of the distal portion of the envelope member when the fixing member is released; and wherein the fixing member comprises silicone.

5. The system of claim 1, wherein the envelope component is a woven mesh envelope component; and wherein the envelope component comprises nitinol.

6. A delivery assembly for a percutaneous medical device, the delivery assembly comprising: A delivery tube having an inner lumen configured to removably accommodate a deployment portion of the percutaneous medical device; and A delivery device comprising: a sleeve member having a sleeve wall, wherein the diameter of a middle portion of the sleeve member is greater than the diameter of a proximal end and a distal end of the sleeve member; and a tethering assembly extending from the sleeve wall, the sleeve member being configured to removably cover the deployment portion with the sleeve wall, and the tethering assembly being configured to facilitate extraction of the sleeve member from the covered deployment portion and from the delivery lumen.

7. The delivery assembly of claim 6, wherein the tethering assembly is fixedly connected to the envelope member.

8. The delivery assembly of claim 6, wherein the tethering assembly includes a collar connecting the tethering assembly to the occlusal member at a proximal end of the occlusal member, and wherein the collar is configured to inhibit movement of the occlusal member relative to the percutaneous medical device.

9. The delivery assembly of claim 6, wherein the distal portion of the envelope member includes a retaining member configured to inhibit expansion of the distal portion of the envelope member when the retaining member is secured, and to allow expansion of the distal portion of the envelope member when the retaining member is released.

10. The delivery assembly of claim 9, wherein the envelope member is a woven mesh envelope member; and wherein the fixing member comprises silicone.

11. The delivery assembly of claim 6, wherein the envelope member comprises nitinol.

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