Cannula-integrated circulatory support device
The braided cannula with a tapered expandable mesh and secure adapter system addresses flow capacity limitations in circulatory assist devices, enhancing blood flow and durability for improved heart support.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- BOSTON SCIENTIFIC SCIMED INC
- Filing Date
- 2025-01-08
- Publication Date
- 2026-06-15
Smart Images
Figure 0007874202000001 
Figure 0007874202000002 
Figure 0007874202000003
Abstract
Description
【Technical Field】 【0001】 The present disclosure relates to a percutaneous circulatory assist device. More specifically, the present disclosure relates to an integrated braided cannula for a circulatory assist pump. 【Background Art】 【0002】 Circulatory assist devices assist the pumping action of the heart. These devices can be placed, for example, through a valve opening such as the aortic valve. The blood flow through the circulatory assist device is an important factor when identifying different types of circulatory assist devices. 【Summary of the Invention】 【0003】 Embodiments disclosed herein relate to a circulatory assist device having improved flow capacity compared to conventional embodiments. Exemplary embodiments include, but are not limited to, the following examples. 【0004】 Example 1 is a device attached to a heart pump, the device comprising an adapter configured to receive the heart pump and having an annular cross-sectional portion fixed to the heart pump, and a plurality of channels disposed around the adapter, the device comprising a cannula having a proximal portion, a distal portion, and an intermediate portion, the intermediate portion comprising a braided mesh extending between the distal portion and the proximal portion, the proximal portion having a proximal end comprising a plurality of elements disposed through the channels, the distal portion comprising a plurality of wires and a tip element, the plurality of wires extending distally from the braided mesh to the tip element, the plurality of wires being fixed to the tip element, and the device comprising a coating covering at least a portion of the braided mesh. 【0005】 In Example 2, in the device of Example 1, the proximal portion of the braided mesh comprises a tapered portion, the tapered portion having an increasing diameter from the proximal end of the tapered portion to the distal end of the tapered portion. In Example 3, in any one of the devices of Example 1 or 2, the braided mesh has a constant pitch. 【0006】 In Example 4, the braided mesh has a variety of pitches in either the apparatus from Example 1 or 2. In Example 5, in one of the devices from Examples 1 to 3, the channel extends along the inner surface of the adapter. 【0007】 In Example 6, the channel extends along the entire length of the adapter, as in the device of Example 5. In Example 7, in any one of the devices from Examples 1 to 6, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongated members, the plurality of elongated members extending from the distal cylindrical portion to the proximal cylindrical portion, and grooves extending through the thickness of the adapter separate each of the elongated members. 【0008】 In Example 8, in one of the devices from Examples 1 to 7, at least one of the multiple channels extends in the longitudinal direction. In Example 9, in any one of the devices in Examples 1 to 8, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions, the one or more intermediate cylindrical portions extending between the distal cylindrical portion and the proximal cylindrical portion, the intermediate cylindrical portions having a smaller diameter than the distal cylindrical portion, and the channel extending through the length of the distal cylindrical portion. 【0009】 In Example 10, in any one of the devices from Examples 1 to 9, the multiple elements arranged through the channel are multiple loop elements. Example 11 is a method for manufacturing a device to be attached to a heart pump, the method comprising the steps of: positioning the proximal ends of a plurality of wires through a plurality of channels of an adapter; braiding the intermediate portions of the plurality of wires to create a braided mesh; extending the distal portions of the plurality of wires distally; coating at least a portion of the braided mesh; and connecting the distal ends of the distal portions to a tip element. 【0010】 In Example 12, the braided mesh has a constant pitch in the method of Example 11. In Example 13, the braided mesh has a variety of pitches in the method of Example 11. In Example 14, in any one of the methods in Examples 11 to 13, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongated members, the plurality of elongated members extending from the distal cylindrical portion to the proximal cylindrical portion, a groove extending through the thickness of the adapter separating each of the elongated members, and the step of aligning the proximal ends of a plurality of wires through a plurality of channels comprises aligning the proximal ends through the grooves. 【0011】 In Example 15, in any one of the methods in Examples 11 to 13, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions, the one or more intermediate cylindrical portions extending between the distal cylindrical portion and the proximal cylindrical portion, the intermediate cylindrical portions having a smaller diameter than the distal cylindrical portion, the channels extending through the length of the distal cylindrical portion, and the step of aligning the proximal ends of multiple wires through multiple channels comprises aligning the proximal ends through channels. 【0012】 Example 16 provides a device to be attached to a heart pump, the device comprising an adapter, the adapter having an annular cross-section configured to receive the heart pump and fixed to the heart pump, and a plurality of channels arranged around the adapter, the device comprising a cannula, the cannula comprising a proximal portion, a distal portion, and an intermediate portion, the intermediate portion comprising a braided mesh extending between the distal portion and the proximal portion, the proximal portion having a proximal end comprising a plurality of elements arranged through the channels, the distal portion comprising a plurality of wires and a tip element, the plurality of wires extending distally from the braided mesh to the tip element, the plurality of wires being fixed to the tip element, and the device comprising a coating covering at least a portion of the braided mesh. 【0013】 In Example 17, the apparatus of Example 16 has a tapered portion in the proximal part of the braided mesh, and the diameter of the tapered portion increases from the proximal end to the distal end. 【0014】 In Example 18, the braided mesh has a constant pitch in the apparatus of Example 16. In Example 19, the braided mesh has various pitches in the apparatus of Example 16. In Example 20, the channel extends along the inner surface of the adapter, as in the apparatus of Example 16. 【0015】 In Example 21, the channel extends along the entire length of the adapter, as in the device of Example 20. In Example 22, in the apparatus of Example 16, at least one of the multiple channels extends in the longitudinal direction. 【0016】 In Example 23, the device of Example 16 comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongated members, the plurality of elongated members extending from the distal cylindrical portion to the proximal cylindrical portion, and grooves extending through the thickness of the adapter separate each of the elongated members. 【0017】 In Example 24, in the apparatus of Example 23, the elongated member extends along the inner surface of the distal cylindrical portion, the proximal cylindrical portion, or both. In Example 25, in the apparatus of Example 24, the elongated member extends along the entire length of the distal cylindrical portion, the proximal cylindrical portion, or both. 【0018】 In Example 26, the device of Example 16 comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions, the one or more intermediate cylindrical portions extending between the distal cylindrical portion and the proximal cylindrical portion, the intermediate cylindrical portions having a smaller diameter than the distal cylindrical portion, and the channel extending through the length of the distal cylindrical portion. 【0019】 In Example 27, in the apparatus of Example 16, multiple elements are multiple loop elements. Example 28 is a method for manufacturing an apparatus, the method comprising the steps of: positioning the proximal ends of a plurality of wires through a plurality of channels of an adapter; braiding the intermediate portions of the plurality of wires to create a braided mesh; extending the distal portions of the plurality of wires distally; coating at least a portion of the braided mesh; and connecting the distal ends of the distal portions to a tip element. 【0020】 In Example 29, the method of Example 28 includes the step of braiding the intermediate portion, wherein the diameter of the tapered portion increases from the proximal end to the distal end. 【0021】 In Example 30, the braided mesh has a constant pitch in the method of Example 28. In Example 31, the braided mesh has various pitches in the method of Example 28. In Example 32, the method of Example 28 comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongated members, the plurality of elongated members extending from the distal cylindrical portion to the proximal cylindrical portion, grooves extending through the thickness of the adapter separating each of the elongated members, and the step of aligning the proximal ends of a plurality of wires through a plurality of channels comprises aligning the proximal ends through the grooves. 【0022】 In Example 33, in the method of Example 28, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions, the one or more intermediate cylindrical portions extending between the distal cylindrical portion and the proximal cylindrical portion, the intermediate cylindrical portions having a smaller diameter than the distal cylindrical portion, the channels extending through the length of the distal cylindrical portion, and the step of aligning the proximal ends of multiple wires through multiple channels comprises aligning the proximal ends through channels. 【0023】 Example 34 further includes the step of attaching the adapter to the heart pump in the method of Example 28. In Example 35, the coating is silicone in the method of Example 28. 【0024】 While multiple embodiments are disclosed, those skilled in the art will recognize from the following detailed description, which illustrates and describes exemplary embodiments of the disclosed subject matter, that still other embodiments of the disclosed subject matter will become apparent. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive. 【Brief Description of the Drawings】 【0025】 [Figure 1] Conceptual diagram of a circulatory assist device including a cannula and an adapter according to an embodiment of the subject matter disclosed herein. [Figure 2] Side view of the circulatory assist device 102 shown in FIG. 1 including the pump 103 according to an embodiment of the subject matter disclosed herein. [Figure 3] Side view of the distal portion of the cannula shown in FIG. 2 according to an embodiment of the subject matter disclosed herein. [Figure 4] Side view of the proximal portion of the cannula and adapter shown in FIG. 2 according to an embodiment of the subject matter disclosed herein. [Figure 5A] Perspective view of an exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 5B] Side view of the exemplary adapter of FIG. 5A with a wire element coupled thereto according to an embodiment of the subject matter disclosed herein. [Figure 6A] Perspective view of another exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 6B] [[ID=3,2]]Side view of the exemplary adapter of FIG. 6A with a wire element coupled thereto according to an embodiment of the subject matter disclosed herein. [[ID=,34]] [Figure 7A] Perspective view of yet another exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 7B] Side view of the exemplary adapter of FIG. 7A including a wire loop according to an embodiment of the subject matter disclosed herein. [Figure 8] Perspective view of yet another exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 9] Another perspective view of an exemplary adapter including a wire loop, according to an embodiment of the subject matter disclosed herein. [Figure 10] A side view of an exemplary mandrel used to form an exemplary cannula according to an embodiment of the subject disclosed herein. [Figure 11] A side view of the distal portion of an exemplary mandrel shown in Figure 10, according to an embodiment of the subject disclosed herein. [Figure 12] A side view of another exemplary mandrel used to form an exemplary cannula according to embodiments of the subject disclosed herein. [Figure 13] A side view of yet another exemplary mandrel used to form an exemplary cannula according to embodiments of the subject disclosed herein. [Figure 14A] This specification shows different pitches used in exemplary mandrels according to embodiments of the subject matter disclosed herein. [Figure 14B] This specification shows different pitches used in exemplary mandrels according to embodiments of the subject matter disclosed herein. [Figure 15] A side view of an exemplary cannula having a film coating, according to an embodiment of the subject disclosed herein, is shown. [Modes for carrying out the invention] 【0026】 The subject matter disclosed is adaptable to various modifications and alternative forms, but the drawings illustrate specific embodiments as examples, and these specific embodiments are described in detail below. However, it is not intended to limit the subject matter disclosed herein to the specific embodiments described herein. On the contrary, this disclosure is intended to encompass all modifications, equivalents, and alternative forms that fall within the scope of the subject matter disclosed herein and are defined by the appended claims. 【0027】 Embodiments disclosed herein include a circulating assist device having improved fluidity compared to conventional embodiments. Figure 1 shows a conceptual diagram of a circulatory assist device 102, including a cannula 104 and an adapter 108, according to an embodiment of the subject disclosed herein. The circulatory assist device 102 is shown positioned within the heart 110. According to the embodiment, the circulatory assist device 102 may include a ventricular assist device (shown in Figure 2), such as a pump, which is coupled to the cannula 104 by the adapter 108. The ventricular assist device is configured to pump blood from the patient's left ventricle 112 into the patient's aorta 114. In several embodiments, the circulatory assist device 102 can be used to treat cardiogenic shock and other heart failure modalities. 【0028】 In several embodiments, 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 several embodiments, the proximal portion 122 of the cannula 104 is coupled to an adapter 108, which 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 delivery of blood from any other aspect of the subject's vascular system into an adjacent portion of the vascular system. 【0029】 Figure 1 is not intended to imply any limitation on the scope of use or functionality of the embodiments of this disclosure. Figure 1 should also not be construed as having any dependence or requirement on any single component or combination of components shown therein. In addition, the various components shown in Figure 1 can be integrated in some embodiments with various other components (and / or components not shown) shown in those embodiments, all of which are considered to be within the scope of this disclosure. 【0030】 Figure 2 shows a side view of the circulatory support device 102 shown in Figure 1, including a ventricular support device 103, according to an embodiment of the subject matter disclosed herein. As described above, the cannula 104 may include a proximal portion 122, an intermediate portion 118, and a distal portion 116. The intermediate portion 118 may include a braided mesh 124 extending between the proximal portion 122 and the distal portion 116. In several embodiments, the braided mesh 124 may have various braiding angles and / or different braiding angles, as will be described in more detail later. In several embodiments, the proximal portion 126 of the braided mesh 124 may be tapered. The tapered proximal portion 126 may allow the braided mesh 124 to transition from the larger diameter near the distal end 128 of the proximal portion 126 (e.g., 5 millimeters (mm) or more) to the smaller diameter near the proximal end 130 of the braided mesh 124. In several embodiments, the braided mesh 124 may be reduced to a smaller diameter for delivery into the heart 110. When placed within the heart 110, the braided mesh 124 can be expanded to its larger diameter. Because the cannula 104 is expandable to a diameter larger than its delivery form, it can provide a greater flow rate than that which may be provided by a smaller, non-expandable cannula. In several embodiments, the braided mesh 124 can be designed to adequately withstand the pressure gradient between the inside and outside of the cannula 104. 【0031】 In several embodiments, the braided mesh 124 is coated with a membrane to form a groove through the cannula 104 from the distal portion 116 to the proximal portion 122. In several embodiments, the membrane may be silicone. In several embodiments, the cannula 104 is formed from multiple nitinol wires having a diameter of 0.2032 millimeters (0.008 inches). However, this is merely an example, and the cannula 104 can be formed using other types of wires having other diameters. Additionally or alternatively, the cannula 104 can be formed using wires having various diameters. In several embodiments, the cannula 104 can be formed from various nitinol wires (e.g., 6-wire to 48-wire). 【0032】 Figure 2 is not intended to imply any limitation on the scope of use or functionality of the embodiments of this disclosure. Figure 2 should also not be construed as having any dependence or requirement on any single component or combination of components shown therein. Furthermore, the various components shown in Figure 2 can, in embodiments, be integrated with various other components shown therein (and / or components not shown), all of which are considered to be within the scope of this disclosure. 【0033】 Figure 3 shows a side view of the distal portion 116 of the cannula 104 shown in Figure 2, according to an embodiment of the subject matter disclosed herein. In some embodiments, at the distal end 132 of the braided mesh 124, the wire of the cannula 104 may include a plurality of wires 134 that extend distally and are coupled to a tip element 136. The space between the plurality of wires 134 provides an entry point for blood to enter the cannula 104. Additionally or alternatively, the tip element 136 can prevent tissue aspiration into the cannula 104. Additionally or alternatively, the tip element 136 may be radiopaque to help determine the proper positioning of the cannula 104. In some embodiments, the tip element 136 may include an opening at its distal end 138, so that a guidewire can be passed through the opening to guide the cannula 104 to the proper location within the heart 110. 【0034】 Figure 3 is not intended to imply any limitation on the scope of use or functionality of the embodiments of this disclosure. Figure 3 should also not be construed as having any dependence or requirement on any single component or combination of components shown therein. Furthermore, the various components shown in Figure 3 can, in embodiments, be integrated with various other components shown therein (and / or components not shown), all of which are considered to be within the scope of this disclosure. 【0035】 Figure 4 shows a side view of the proximal portion 122 of the cannula 104 and adapter 108 shown in Figure 2, according to an embodiment of the subject disclosed herein. In some embodiments, the proximal portion 122 of the cannula 104 may have an annular cross-section and be coupled to the adapter 108. For example, the braided mesh 124 may include a plurality of wire elements 140, which are arranged through the channel of the adapter 108 so as to interlock the wires of the cannula 104 with the adapter 108, as will be described in more detail later. In some embodiments, the plurality of wire elements 140 may be a plurality of wire loop elements. In some embodiments, any of the wire loop elements considered herein may be replaced with linear elements and / or other wire elements. For example, the wire element 140 may be a linear element, which is arranged through the channel of the adapter 108 and is fixed to the adapter 108 by a crimp between the adapter 108 and the proximal portion 122 of the cannula 104. In several embodiments, the element 140 can be welded to the adapter 108 and / or fixed to the adapter in another manner, for example, using an adhesive. The wire element 140 facilitates the attachment of the braided mesh 124 to the adapter 108 while maintaining a small cross-sectional profile relative to the proximal portion 122 of the cannula 104. 【0036】 In several embodiments, the adapter 108 can also be connected to the ventricular assist device 103, thereby facilitating blood flow through the cannula 104. In several embodiments, the adapter 108 can be connected to the ventricular assist device 103 by welding, soldering, screw fitting, etc. 【0037】 Figure 4 is not intended to imply any limitation on the scope of use or functionality of the embodiments of this disclosure. Figure 4 should also not be construed as having any dependence or requirement on any single component or combination of components shown therein. Furthermore, the various components shown in Figure 4 can be integrated in embodiments with various other components shown therein (and / or components not shown), all of which are considered to be within the scope of this disclosure. 【0038】 Figure 5A shows a perspective view of an exemplary adapter 200 according to an embodiment of the subject disclosed herein, and Figure 5B shows a side view of an exemplary adapter 200 with a wire element coupled to it, according to an embodiment of the subject disclosed herein. Similar to adapter 108, adapter 200 can secure a cannula (e.g., cannula 104) to a circulatory support device (e.g., circulatory support device 102). As shown, adapter 200 may have a generally annular cross-sectional profile having an inner diameter capable of receiving a circulatory support device. In several embodiments, the inner diameter of adapter 200 can be configured to accommodate circulatory support devices of different sizes. For example, the inner diameter of adapter 200 may range from 4.2418 mm (0.167 inches) to 4.699 mm (0.185 inches). In other examples, the inner diameter of adapter 200 may be less than 4.2418 mm (0.167 inches). In other examples, the inner diameter of adapter 200 can exceed 4.699 millimeters (0.185 inches). 【0039】 In the illustrated embodiments, the adapter 200 also includes a plurality of channels 202 arranged circumferentially on the inner surface 204 of the adapter 200. In some embodiments, the channels 202 may extend along the entire length 206 of the adapter 200. In some embodiments, the channels 202 may form a post 208 extending from the distal end 210 of the adapter 200 to the proximal end 212 of the adapter 200. For example, one post 208 may be formed between two of the plurality of channels 202. In some embodiments, the post 208 can secure the loop element of a cannula (e.g., cannula 104) to the adapter 200. For example, as shown in Figure 5B, the wire of the cannula may be routed through a first channel 202 of the plurality of channels 202, around the proximal end 212 of the post 208, and through a second channel 202 of the plurality of channels 202, so as to form a wire loop 214. When the adapter 200 is coupled to the circulation assist device 102, the post 208 provides a tight fit with the circulation assist device 102, preventing the wire loop 214 from being pulled out of the adapter 200. 【0040】 Figure 6A shows a perspective view of another exemplary adapter 300 according to an embodiment of the subject disclosed herein, and Figure 6B shows a side view of an exemplary adapter 300 with a wire element coupled, according to an embodiment of the subject disclosed herein. Similar to adapter 108, adapter 300 can secure a cannula (e.g., cannula 104) to a circulatory support device (e.g., circulatory support device 102). As shown, adapter 300 may have a generally annular cross-sectional profile having an inner diameter capable of receiving a circulatory support device. In several embodiments, the inner diameter of adapter 300 can be configured to accommodate circulatory support devices of different sizes. For example, the inner diameter of adapter 300 may range from 4.2418 mm (0.167 inches) to 4.699 mm (0.185 inches). In other examples, the inner diameter of adapter 300 may be less than 4.2418 mm (0.167 inches). In other examples, the inner diameter of adapter 300 can exceed 4.699 millimeters (0.185 inches). 【0041】 In several embodiments, the adapter 300 may include a distal cylindrical portion 302 and a proximal cylindrical portion 304. In several embodiments, the adapter 300 may also include a plurality of elongated members 306 extending between the distal cylindrical portion 302 and the proximal cylindrical portion 304. Additionally or alternatively, grooves 308 extending through the thickness of the adapter 300 can separate each of the elongated members 306. In several embodiments, the distal cylindrical portion 302, the proximal cylindrical portion 304 and the plurality of elongated members 306 may be monolithic members. Alternatively, the distal cylindrical portion 302, the proximal cylindrical portion 304 and / or the plurality of elongated members 306 may be separate members. 【0042】 In several embodiments, the adapter 300 includes a plurality of channels 310 arranged circumferentially on the inner surface 312 of the distal cylindrical portion 302, the proximal cylindrical portion 304, or both. In the illustrated embodiment, the channels 310 may extend along the entire length 314 of the distal cylindrical portion 302 and / or the entire length 316 of the proximal cylindrical portion 304. 【0043】 Referring to Figure 6B, the channels 310 and / or the elongated member 306 can prevent the loop element of the cannula (e.g., cannula 104) from being pulled out of the adapter 300. For example, the wire of the cannula can be positioned to pass through the first channel 310 of the multiple channels 310, around the elongated member 306, and through the second channel 310 of the multiple channels 310 to form a wire loop 318. By positioning the wire loop 318 around the elongated member 306, the wire loop 318 can be prevented from being pulled out of the adapter 300. 【0044】 Figure 7A shows a perspective view of yet another exemplary adapter 400 according to an embodiment of the subject disclosed herein, and Figure 7B shows a side view of an exemplary adapter 400 including a wire loop according to an embodiment of the subject disclosed herein. Similar to adapter 108, adapter 400 can secure a cannula (e.g., cannula 104) to a circulatory support device (e.g., circulatory support device 102). As shown, adapter 400 may have a generally annular cross-sectional profile having an inner diameter capable of receiving a circulatory support device. In several embodiments, the inner diameter of adapter 400 can be configured to accommodate circulatory support devices of different sizes. For example, the inner diameter of adapter 400 may range from 4.2418 mm (0.167 inches) to 4.699 mm (0.185 inches). In other examples, the inner diameter of adapter 400 may be less than 4.2418 mm (0.167 inches). In other examples, the inner diameter of adapter 400 can exceed 4.699 millimeters (0.185 inches). 【0045】 In several embodiments, the adapter 400 may include a distal cylindrical portion 402 and a proximal cylindrical portion 404. In several embodiments, the adapter 400 may also include a plurality of elongated members 406 extending between the distal cylindrical portion 402 and the proximal cylindrical portion 404. Additionally or alternatively, grooves 408 extending through the thickness of the adapter 400 may separate each of the elongated members 406. In several embodiments, the distal cylindrical portion 402, the proximal cylindrical portion 404 and the plurality of elongated members 406 may be monolithic members. Alternatively, the distal cylindrical portion 402, the proximal cylindrical portion 404 and the plurality of elongated members 406 may be separate members. 【0046】 In several embodiments, the adapter 400 includes a plurality of channels 410 arranged circumferentially on the inner surface 412 of the distal cylindrical portion 402, the proximal cylindrical portion 404, or both. In the illustrated embodiment, the channels 410 may extend along the entire length 414 of the distal cylindrical portion 402 and / or along only a portion of the length 416 of the proximal cylindrical portion 404. By extending (the channels 410) along only a portion of the length 416 of the proximal cylindrical portion 404, the proximal cylindrical portion 404 may have a relatively larger diameter located near the proximal end 418 of the adapter 400. Thus, the adapter 400 can accommodate a larger diameter circulating aid compared to embodiments in which the channels 410 extend along the entire length 416 of the proximal cylindrical portion 404. Alternatively, if the same size circulatory support device is used in both embodiments, the adapter 400 may have a smaller cross-sectional profile than when the adapter 400 includes a channel 410 extending along the entire length 416 of the proximal cylindrical portion 404. 【0047】 Referring to Figure 7B, the channels 410 and / or the elongated member 406 can prevent the loop element of the cannula (e.g., cannula 104) from being pulled out of the adapter 400. For example, the wire of the cannula can be positioned to pass through the first channel 410 of the multiple channels 410, around the elongated member 406, and then through the second channel 410 of the multiple channels 410 to form a wire loop 420. By positioning the wire loop 420 around the elongated member 406, the wire loop 420 can be prevented from being pulled out of the adapter 400. 【0048】 Figure 8 shows a perspective view of yet another exemplary adapter 500 according to embodiments of the subject matter disclosed herein. Similar to adapter 108, adapter 500 can secure a cannula (e.g., cannula 104) to a circulatory support device (e.g., circulatory support device 102). As shown, adapter 500 may have a generally annular cross-sectional profile having an inner diameter capable of receiving a circulatory support device. In several embodiments, the inner diameter of adapter 500 may be configured to accommodate circulatory support devices of different sizes. For example, the inner diameter of adapter 500 may range from 4.2418 mm (0.167 inches) to 4.699 mm (0.185 inches). In other examples, the inner diameter of adapter 500 may be less than 4.2418 mm (0.167 inches). In yet another example, the inner diameter of adapter 500 may exceed 4.699 mm (0.185 inches). 【0049】 In several embodiments, the adapter 500 may include a distal cylindrical portion 502 and a proximal cylindrical portion 504. In several embodiments, the adapter 500 may also include one or more intermediate cylindrical portions 506 extending between the distal cylindrical portion 502 and the proximal cylindrical portion 504. In several embodiments, the distal cylindrical portion 502, the proximal cylindrical portion 504 and the one or more intermediate cylindrical portions 506 may be monolithic members. Alternatively, the distal cylindrical portion 502, the proximal cylindrical portion 504 and / or the one or more intermediate cylindrical portions 506 may be separate members. 【0050】 In several embodiments, the adapter 500 includes several channels 508 arranged circumferentially in the distal cylindrical portion 502. In the illustrated embodiment, the channels 508 can extend along the entire length 510 of the distal cylindrical portion 502. In several embodiments, the cannula wire can be positioned to pass through a first channel 508 of the several channels 508, around the proximal end 512 of the distal cylindrical portion 502, and through a second channel 508 of the several channels 508, thereby forming a wire loop that is prevented from being pulled out of the adapter 500. 【0051】 Figure 9 shows a perspective view of yet another exemplary adapter 600 according to embodiments of the subject matter disclosed herein. Similar to adapter 108, adapter 600 can secure a cannula (e.g., cannula 104) to a circulatory support device (e.g., circulatory support device 102). As shown, adapter 600 may have a generally annular cross-sectional profile having an inner diameter capable of receiving a circulatory support device. In several embodiments, the inner diameter of adapter 600 may be configured to accommodate circulatory support devices of different sizes. For example, the inner diameter of adapter 600 may range from 4.2418 mm (0.167 inches) to 4.699 mm (0.185 inches). In other examples, the inner diameter of adapter 600 may be less than 4.2418 mm (0.167 inches). In yet another example, the inner diameter of adapter 600 may exceed 4.699 mm (0.185 inches). 【0052】 In several embodiments, the adapter 600 may include a distal cylindrical portion 602 and a proximal cylindrical portion 604. In several embodiments, the adapter 600 may also include one or more intermediate cylindrical portions 606 extending between the distal cylindrical portion 602 and the proximal cylindrical portion 604. In several embodiments, the distal cylindrical portion 602, the proximal cylindrical portion 604 and the one or more intermediate cylindrical portions 606 may be monolithic members. Alternatively, the distal cylindrical portion 602, the proximal cylindrical portion 604 and / or the one or more intermediate cylindrical portions 606 may be separate members. 【0053】 In several embodiments, the adapter 600 includes several channels 608 arranged circumferentially in the distal cylindrical portion 602. In the illustrated embodiment, the channels 608 can extend along the entire length 610 of the distal cylindrical portion 602. In several embodiments, the cannula wire can be positioned to pass through a first channel 608 of the several channels 608, around the proximal end 612 of the distal cylindrical portion 602, and through a second channel 608 of the several channels 608 to form a wire loop 614 that is prevented from being pulled out of the adapter 500. In several embodiments, the wire loop 614 can be located in a trough (directly below the wire loop 614) to prevent lateral movement of the wire loop 614. 【0054】 Figure 10 shows a side view of an exemplary mandrel 700 used to form an exemplary cannula according to embodiments of the subject disclosed herein. As shown, the mandrel 700 comprises a proximal portion 702 to which an adapter 708 is coupled, an intermediate portion 704, and a distal portion 706. The proximal portion of the wire 712 (shown in Figure 11) can be positioned through a channel in the adapter 708 to fix and maintain the wire 712 while the braiding of the wire 712 is being carried out. In some embodiments, the mandrel 700 also includes a plurality of projections 710. As shown in Figure 11, which shows a side view of the distal portion of the exemplary mandrel shown in 700 in Figure 10, the wire 712 can be wrapped around and / or braided around the plurality of projections 710 to form a braided mesh (braided mesh 124) of the cannula (e.g., cannula 104). In some embodiments, the intermediate portion 704 may include projections 710 having a constant pitch or varying pitches. 【0055】 Figure 12 shows an exemplary mandrel 800 including projections 802 having a constant pitch, and Figure 13 shows an exemplary mandrel 900 including projections 902 having varying pitches. In some embodiments, the pitch angle is the angle formed by the two proximal edges and / or the two distal edges of the projection. Referring to, for example, Figures 14A and 14B, two different pitch angles are shown. In Figure 14A, projection 1002 has an edge 1004 that forms a pitch angle of 78 degrees. In comparison, projection 1102 has an edge 1104 that forms a pitch angle of 110 degrees. However, these are merely examples and are not intended to be limiting, and the pitch angle may range from approximately 30 degrees to 150 degrees. 【0056】 In several embodiments, the pitch angle can determine the dimetric and / or axial strength of a cannula (e.g., cannula 104). For example, a larger pitch angle makes it easier to achieve a greater dimetric strength while also easily achieving a lower axial strength. Conversely, a smaller pitch angle makes it easier to achieve a lower dimetric strength while also easily achieving a greater axial strength. In several embodiments, the dimetric and / or axial strength can be configured for a given application of the cannula and / or selected to withstand a pressure gradient between the inside and outside of the cannula. 【0057】 Referring again to Figure 10, the intermediate portion 704 may include a tapered portion 714 that can be used to form a tapered proximal portion of the cannula (e.g., tapered proximal portion 126). 【0058】 In several embodiments, once the wire 712 is braided through the projection 710 to the distal end 716 of the projection 710, all other wires 712 can be arranged to be looped and folded back and returned through the projection 710. The wires 712 that are not looped and folded back can be arranged through the groove 718 of the distal portion 706. In several embodiments, once the shape of the wire 712 is formed, the looped and folded portion of the wire 712 or the entire wire 712 can be welded, bonded, stabilized, and / or heat-treated to shape the wire 712. The cannula can then be removed from the mandrel 700. After the cannula is removed from the mandrel 700, it can be coated with a membrane. 【0059】 Figure 15 shows a side view of an exemplary cannula 1200 having a membrane coating 1202 removed from a mandrel (e.g., mandrel 700) according to embodiments of the subject disclosed herein. In some embodiments, the membrane may be silicone. As shown, the proximal portion 1204 includes a plurality of proximal wire portions 1206 extending in the proximal direction. In at least some embodiments, the proximal wire portions 1206 may extend in the longitudinal direction. These wires 1206 can be looped through an adapter (e.g., any one of the adapters 108, 200, 300, 400, 500, 600 described above) and then secured to a circulatory assist device. In some embodiments, the distal portion 1208 includes a plurality of distal wire portions 1210 extending in the distal direction. In at least some embodiments, the distal wire portions 1210 extend in the longitudinal direction. As described above, these wires 1210 can be coupled to a chip element (for example, the chip element 136 described above). 【0060】 (Note) As a preferred embodiment, the technical concept that can be understood from the above embodiment is described below. [Note 1] A device attached to a heart pump, The device includes an adapter, and the adapter is An annular cross-section portion configured to receive the aforementioned heart pump and fixed to the heart pump, Multiple channels arranged around the adapter, The distal cylindrical portion, The proximal cylindrical portion, Multiple elongated members and The adapter comprises a plurality of elongated members extending from the distal cylindrical portion to the proximal cylindrical portion, and a plurality of grooves extending through the thickness of the adapter separate each of the elongated members. The device comprises a cannula, the cannula comprising a proximal portion, a distal portion, and an intermediate portion, the intermediate portion comprising a braided mesh extending between the distal portion and the proximal portion, the proximal portion having a proximal end comprising a plurality of elements arranged through the channel, the distal portion comprising a plurality of wires and a tip element, the plurality of wires extending distally from the braided mesh to the tip element, and the plurality of wires being fixed to the tip element. The device includes a coating that covers at least a portion of the braided mesh. Device. [Note 2] The apparatus as described in Appendix 1, wherein the proximal portion of the braided mesh has a tapered portion, and the diameter of the tapered portion increases from the proximal end to the distal end of the tapered portion. [Note 3] The apparatus according to Appendix 1 or 2, wherein the braided mesh has a constant pitch. [Note 4] The apparatus according to Appendix 1 or 2, wherein the braided mesh has various pitches. [Note 5] The apparatus according to any one of the appendices 1 to 3, wherein the channel extends along the inner surface of the adapter. [Note 6] The apparatus as described in Appendix 5, wherein the channel extends along the entire length of the adapter. [Note 7] The apparatus according to any one of the appendices 1 to 6, wherein at least one of the plurality of channels extends in the longitudinal direction. [Note 8] A device attached to a heart pump, The device includes an adapter, and the adapter is An annular cross-section portion configured to receive the aforementioned heart pump and fixed to the heart pump, Multiple channels arranged around the adapter, The distal cylindrical portion, The proximal cylindrical portion, It comprises one or more intermediate cylindrical portions, the one or more intermediate cylindrical portions extending between the distal cylindrical portion and the proximal cylindrical portion, the intermediate cylindrical portions having a smaller diameter than the distal cylindrical portion, and the channel extending through the length of the distal cylindrical portion. The device comprises a cannula, the cannula comprising a proximal portion, a distal portion, and an intermediate portion, the intermediate portion comprising a braided mesh extending between the distal portion and the proximal portion, the proximal portion having a proximal end comprising a plurality of elements arranged through the channel, the distal portion comprising a plurality of wires and a tip element, the plurality of wires extending distally from the braided mesh to the tip element, and the plurality of wires being fixed to the tip element. The device includes a coating that covers at least a portion of the braided mesh. Device. [Note 9] The apparatus according to any one of the appendices 1 to 8, wherein the plurality of elements arranged through the channel are a plurality of loop elements. [Note 10] A method for manufacturing the apparatus described in Appendix 1, wherein the method is The steps include arranging the proximal ends of multiple wires through the multiple channels of the adapter, The steps include: braiding the intermediate portions of the plurality of wires in order to create the braided mesh; The steps include extending the distal portions of the plurality of wires in the distal direction, The steps include coating at least a portion of the braided mesh with the coating, The steps include: connecting the distal end of the distal portion to the tip element; A method that includes [a certain feature]. [Note 11] The braided mesh has a constant pitch, as described in Appendix 10. [Note 12] The braided mesh has various pitches, as described in Appendix 10. Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of this disclosure. For example, while the embodiments described above refer to certain features, the scope of this disclosure also includes embodiments having different combinations of features, and embodiments that do not include all of the features described. Accordingly, the scope of this disclosure is intended to encompass all such alternative forms, modifications, and variations within the scope of the claims, along with all their equivalents.
Claims
[Claim 1] A circulatory support device, The circulatory support device includes a cardiac pump, The circulatory support device comprises a cannula having a proximal portion, an intermediate portion, and a distal portion, the proximal portion being connected to the cardiac pump and extending distally from the cardiac pump, The aforementioned intermediate portion consists of a braided mesh formed from multiple wires extending between the proximal portion and the distal portion. The circulatory support device includes an adapter that connects the plurality of wires to the heart pump, The adapter comprises an annular cross-section and a plurality of channels arranged around the adapter. The aforementioned multiple wires are provided in multiple channels. Circulatory support device. [Claim 2] The circulatory support device according to claim 1, wherein the adapter is configured to surround the cardiac pump. [Claim 3] The circulation assist device according to claim 1 or 2, wherein the plurality of channels extend along the entire length of the adapter. [Claim 4] The circulation assist device according to claim 3, wherein the plurality of wires are welded to the adapter. [Claim 5] The circulation assist device according to claim 1 or 2, wherein the plurality of channels extend along the inner surface of the adapter. [Claim 6] The circulation assist device according to claim 5, wherein the plurality of wires are welded to the adapter. [Claim 7] The circulation assist device according to claim 1, wherein the braided mesh has various pitches. [Claim 8] The circulation assist device according to claim 1, wherein the braided mesh has a constant pitch. [Claim 9] The circulation assist device according to claim 1, wherein the plurality of wires extend distally from the braided mesh to its distal end. [Claim 10] The circulation assist device according to claim 1 or 2, wherein the proximal portion comprises a tapered portion, and the diameter of the tapered portion increases from the proximal end to the distal end of the tapered portion. [Claim 11] The circulation assist device according to claim 1 or 2, wherein the braided mesh is configured to expand from a delivery form to an unfolded form. [Claim 12] The circulation assist device according to claim 11, wherein the braided mesh in the deployed form has a diameter of 5 millimeters or more. [Claim 13] The circulation assist device according to claim 1 or 2, further comprising a coating that covers at least a portion of the braided mesh. [Claim 14] A circulatory support device, The circulatory support device includes a cardiac pump, The circulatory support device is equipped with a distal tip, The circulatory support device comprises a cannula extending between the cardiac pump and the distal end, The cannula consists of a braided mesh formed from multiple wires. The circulatory support device comprises an adapter configured to connect the cannula to the heart pump, the adapter comprising a plurality of channels extending along the inner surface of the adapter, The plurality of wires are provided in the plurality of channels to secure the plurality of wires of the cannula to the cardiac pump. Circulatory support device. [Claim 15] The circulation assist device according to claim 14, wherein the braided mesh has various pitches. [Claim 16] The circulation assist device according to claim 14, wherein the braided mesh has a constant pitch. [Claim 17] The circulation assist device according to claim 14, wherein the plurality of wires are welded to the adapter. [Claim 18] The circulation assist device according to any one of claims 14 to 17, wherein the plurality of channels extend along the entire length of the adapter.