Circulatory support device with integrated cannula

Abstract

To provide a circulatory support device with an integrated cannula.SOLUTION: The circulatory support device comprises a cardiac pump. The circulatory support device includes a cannula having a proximal portion, an intermediate portion, and a distal portion. The proximal portion is coupled with the cardiac pump and extends distally from the cardiac pump. The intermediate portion is made of a braided mesh formed of a plurality of wires extending between the proximal portion and the distal portion. The circulatory support device comprises an adapter which couples the wires to the cardiac pump.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] The present disclosure relates to percutaneous circulatory assist devices. More particularly, the present disclosure relates to an integral braided cannula for a circulatory assist pump. [Background technology]

[0002] Circulatory assist devices assist the pumping action of the heart. These devices can be placed through a valve opening, such as the aortic valve. Blood flow through the circulatory assist device is an important factor when distinguishing between different types of circulatory assist devices. Summary of the Invention

[0003] The embodiments disclosed herein relate to circulatory assist devices having improved flow capabilities compared to conventional embodiments. Exemplary embodiments include, but are not limited to, the following examples.

[0004] Example 1 is a device for attachment to a heart pump, the device comprising an adapter configured to receive the heart pump, the adapter comprising an annular cross-section secured to the heart pump and a plurality of channels disposed about the adapter, the device comprising a cannula comprising a proximal portion, a distal portion, and an 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 secured to the tip element, and the device comprising a coating covering at least a portion of the braided mesh.

[0005] In Example 2, the device of Example 1, the proximal portion of the braided mesh comprises a tapered portion that increases in diameter from the proximal end of the tapered portion to the distal end of the tapered portion. In Example 3, the device of any one of Examples 1 or 2, wherein the braided mesh has a constant pitch.

[0006] In Example 4, the device of any one of Examples 1 or 2, wherein the braided mesh comprises a variable pitch. In Example 5, the device of any one of Examples 1-3, wherein the channel extends along an inner surface of the adapter.

[0007] In Example 6, the device of Example 5, the channel extends along the entire length of the adapter. In Example 7, in any one of the devices of Examples 1-6, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongated members extending from the distal cylindrical portion to the proximal cylindrical portion, and a groove extending through the thickness of the adapter separates each of the elongated members.

[0008] In Example 8, the device of any one of Examples 1-7, wherein at least one of the plurality of channels extends in the longitudinal direction. In Example 9, in the device of any one of Examples 1-8, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions extending between the distal and proximal cylindrical portions, 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, the device of any one of Examples 1-9, wherein the plurality of elements disposed through the channel is a plurality of loop elements. Example 11 is a method of manufacturing a device to be attached to a heart pump, the method comprising the steps of placing proximal ends of a plurality of wires through a plurality of channels of an adapter, braiding an intermediate portion of the plurality of wires to create a braided mesh, extending distal portions of the plurality of wires in a distal direction, coating at least a portion of the braided mesh, and bonding a distal end of the distal portion to a tip element.

[0010] In Example 12, the method of Example 11, wherein the braided mesh has a constant pitch. In Example 13, the method of Example 11 is performed where the braided mesh has a variable pitch. In Example 14, in the method of any one of Examples 11-13, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongate members extending from the distal cylindrical portion to the proximal cylindrical portion, and a groove extending through a thickness of the adapter separates each of the elongate members, and the step of placing the proximal ends of the plurality of wires through the plurality of channels comprises placing the proximal ends through the grooves.

[0011] In Example 15, in the method of any one of Examples 11-13, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions extending between the distal cylindrical portion and the proximal cylindrical portion, the intermediate cylindrical portion having a smaller diameter than the distal cylindrical portion, and the channel extending through a length of the distal cylindrical portion, and the step of placing the proximal ends of the plurality of wires through the plurality of channels comprises placing the proximal ends through the channel.

[0012] In Example 16, a device is provided for attachment to a heart pump, the device comprising an adapter configured to receive the heart pump and comprising an annular cross-section secured to the heart pump and a plurality of channels disposed about the adapter, the device comprising a cannula having a proximal portion, a distal portion, and an 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 secured to the tip element, and the device comprising a coating covering at least a portion of the braided mesh.

[0013] In Example 17, the device of Example 16, the proximal portion of the braided mesh comprises a tapered portion, the tapered portion increasing in diameter from the proximal end of the tapered portion to the distal end of the tapered portion.

[0014] In Example 18, the device of Example 16, the braided mesh has a constant pitch. In Example 19, the device of Example 16, the braided mesh has a variable pitch. In Example 20, the device of Example 16, wherein the channel extends along an inner surface of the adapter.

[0015] In Example 21, the device of Example 20, the channel extends along the entire length of the adapter. In Example 22, the device of Example 16, wherein at least one of the plurality of channels extends in a longitudinal direction.

[0016] In Example 23, the device of Example 16, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongate members extending from the distal cylindrical portion to the proximal cylindrical portion, and a groove extending through the thickness of the adapter separates each of the elongate members.

[0017] In Example 24, the device of Example 23, the elongate member extends along an inner surface of the distal cylindrical portion, the proximal cylindrical portion, or both. In Example 25, the device of Example 24, wherein the elongate member extends along the entire length of the distal cylindrical portion, the proximal cylindrical portion, or both.

[0018] In Example 26, in the device of Example 16, the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions extending between the distal and proximal cylindrical portions, 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, the device of Example 16, the plurality of elements is a plurality of loop elements. Example 28 is a method of manufacturing a device, the method comprising the steps of placing proximal ends of a plurality of wires through a plurality of channels of an adapter, braiding an intermediate portion of the plurality of wires to create a braided mesh, extending distal portions of the plurality of wires in a distal direction, coating at least a portion of the braided mesh, and bonding a distal end of the distal portion to a tip element.

[0020] In Example 29, the method of Example 28, wherein the step of braiding the intermediate portion comprises forming a tapered portion, the tapered portion increasing in diameter from a proximal end of the tapered portion to a distal end of the tapered portion.

[0021] In Example 30, the method of Example 28, wherein the braided mesh has a constant pitch. In Example 31, the method of Example 28 is performed wherein the braided mesh has a variable pitch. In Example 32, the method of Example 28, wherein the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and a plurality of elongate members extending from the distal cylindrical portion to the proximal cylindrical portion, and a groove extending through a thickness of the adapter separates each of the elongate members, and the step of placing the proximal ends of the plurality of wires through the plurality of channels comprises placing the proximal ends through the grooves.

[0022] In Example 33, the method of Example 28, wherein the adapter comprises a distal cylindrical portion, a proximal cylindrical portion, and one or more intermediate cylindrical portions extending between the distal and proximal cylindrical portions, the intermediate cylindrical portion having a smaller diameter than the distal cylindrical portion, and the channel extends through a length of the distal cylindrical portion, and the step of placing the proximal ends of the plurality of wires through the plurality of channels comprises placing the proximal ends through the channel.

[0023] In Example 34, the method of Example 28 further comprises attaching the adapter to the heart pump. In Example 35, the method of Example 28 is performed where the coating is silicone.

[0024] While multiple embodiments are disclosed, still other embodiments of the presently disclosed subject matter will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the disclosed subject matter. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0025] [Figure 1] 1 is a conceptual diagram of a circulatory assist device including a cannula and an adapter, according to an embodiment of the subject matter disclosed herein. [Diagram 2] 2 is a side view of the circulatory assist device 102 shown in FIG. 1 including a pump 103, according to an embodiment of the subject matter disclosed herein. [Diagram 3] 3 is a side view of a distal portion of the cannula shown in FIG. 2 according to an embodiment of the subject matter disclosed herein. [Figure 4] 3 is a side view of a proximal portion of the cannula and adapter shown in FIG. 2 according to an embodiment of the subject matter disclosed herein. [Figure 5A] 1 is a perspective view of an exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 5B] 5B is a side view of the example adapter of FIG. 5A having a wire element coupled thereto, according to an embodiment of the subject matter disclosed herein. [Figure 6A] 1 is a perspective view of another exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 6B] 6B is a side view of the example adapter of FIG. 6A having a wire element coupled thereto, according to an embodiment of the subject matter disclosed herein. [Figure 7A] 13 is a perspective view of yet another exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 7B] 7B is a side view of the example adapter of FIG. 7A including a wire loop according to an embodiment of the subject matter disclosed herein. [Figure 8] 13 is a perspective view of yet another exemplary adapter according to an embodiment of the subject matter disclosed herein. [Figure 9] 1 is another perspective view of an exemplary adapter including a wire loop according to an embodiment of the subject matter disclosed herein. [Figure 10] FIG. 2 is a side view of an exemplary mandrel used to form an exemplary cannula in accordance with an embodiment of the subject matter disclosed herein. [Figure 11] 11 is a side view of a distal portion of the exemplary mandrel shown in FIG. 10 according to an embodiment of the subject matter disclosed herein. [Figure 12] FIG. 2 is a side view of another exemplary mandrel used to form an exemplary cannula in accordance with an embodiment of the subject matter disclosed herein. [Figure 13] FIG. 13 is a side view of yet another exemplary mandrel used to form an exemplary cannula in accordance with an embodiment of the subject matter disclosed herein. [Figure 14A] 1 illustrates different pitches used in an exemplary mandrel according to embodiments of the subject matter disclosed herein. [Figure 14B] 1 illustrates different pitches used in an exemplary mandrel according to embodiments of the subject matter disclosed herein. [Figure 15] 1 shows a side view of an exemplary cannula having a membrane coating according to an embodiment of the subject matter disclosed herein. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0026] While the disclosed subject matter is amenable to various modifications and alternative forms, specific embodiments are shown by way of example in the drawings and will now be described in detail. However, it is not intended that the subject matter disclosed herein be limited to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives that are within the scope of the subject matter disclosed herein and are defined by the appended claims.

[0027] The embodiments disclosed herein include circulatory assist devices that have improved flow capabilities compared to conventional embodiments. 1 illustrates a conceptual diagram of a circulatory assist device 102 including a cannula 104 and an adapter 108, according to embodiments of the subject matter disclosed herein. The circulatory assist device 102 is shown positioned within a heart 110. According to embodiments, the circulatory assist device 102 may include a ventricular assist device, such as a pump (shown in FIG. 2 ), coupled to the cannula 104 by the adapter 108. The ventricular assist device is configured to pump blood from a left ventricle 112 of the subject into an aorta 114 of the subject. In embodiments, the circulatory assist device 102 may be used to treat cardiogenic shock and other heart failure modalities.

[0028] In some embodiments, a distal portion 116 of the circulatory assist device 102 is disposed within the left ventricle 112. An intermediate portion 118 of the circulatory assist device 102 extends through the aortic valve 120 such that a proximal portion 122 of the cannula 104 extends into the aorta 114. In some embodiments, the proximal portion 122 of the cannula 104 is coupled to an adapter 108, which is coupled to the circulatory assist device 102. In operation, the circulatory assist device 102 draws blood from the left ventricle 112 through the cannula 104 of the circulatory assist device 102 and expels it into the aorta 114. Additionally or alternatively, the circulatory assist device 102 may be used to facilitate pumping blood from some other aspect of the subject's vascular system into an adjacent portion of the vascular system.

[0029] Figure 1 is not intended to suggest any limitations on the scope of use or functionality of the embodiments of the present disclosure, nor should it be interpreted as having any dependency or requirement regarding any single component or combination of components shown therein. In addition, the various components shown in Figure 1 can be combined in multiple embodiments with various of the other components shown in the multiple embodiments (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0030] FIG. 2 illustrates a side view of the circulatory assist device 102 shown in FIG. 1, including a ventricular assist device 103, according to an embodiment of the subject matter disclosed herein. As discussed 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 embodiments, the braided mesh 124 may have various braid angles and / or varying braid angles, as described in more detail below. In embodiments, the proximal portion 126 of the braided mesh 124 may be tapered. The tapered proximal portion 126 may transition the braided mesh 124 from a larger diameter (e.g., 5 millimeters (mm) or more) 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 be reduced to a smaller diameter for delivery into the heart 110. Once placed within the heart 110, the braided mesh 124 can be expanded to its larger diameter. By being expandable to a diameter larger than its delivery configuration, the cannula 104 can provide a greater flow rate than could be provided by a non-expandable, smaller diameter cannula. In embodiments, the braided mesh 124 can be designed to sufficiently withstand a pressure gradient between the inside and outside of the cannula 104.

[0031] In some embodiments, the braided mesh 124 is coated with a membrane to form a channel through the cannula 104 from the distal portion 116 to the proximal portion 122. In some embodiments, the membrane can be silicone. In some embodiments, the cannula 104 is formed from a plurality of nitinol wires having a diameter of 0.008 inches. However, this is merely one example and other types of wires having other diameters can be used to form the cannula 104. Additionally or alternatively, wires having a variety of diameters can be used to form the cannula 104. In some embodiments, the cannula 104 can be formed from a variety of nitinol wires (e.g., 6 wire to 48 wire).

[0032] Figure 2 is not intended to suggest any limitations as to the scope of use or functionality of the embodiments of the present disclosure, nor should Figure 2 be interpreted as having any dependency or requirement regarding any single component or combination of components shown therein. Moreover, the various components shown in Figure 2 can be combined in embodiments with various of the other components shown therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0033] 3 illustrates a side view of the distal portion 116 of the cannula 104 shown in FIG. 2 according to an embodiment of the subject matter disclosed herein. In embodiments, at the distal end 132 of the braided mesh 124, the wires of the cannula 104 can include multiple wires 134 extending distally and coupled to a tip element 136. Spaces between the multiple wires 134 provide an entrance for blood to enter the cannula 104. Additionally or alternatively, the tip element 136 can prevent the aspiration of tissue into the cannula 104. Additionally or alternatively, the tip element 136 can be radiopaque to aid in determining proper positioning of the cannula 104. In embodiments, the tip element 136 can 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 appropriate location within the heart 110.

[0034] Figure 3 is not intended to suggest any limitations on the scope of use or functionality of the embodiments of the present disclosure, nor should Figure 3 be interpreted as having any dependency or requirement regarding any single component or combination of components shown therein. Moreover, the various components shown in Figure 3 can be combined in embodiments with various of the other components shown therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0035] 4 illustrates a side view of the cannula 104 and the proximal portion 122 of the adapter 108 shown in FIG. 2 according to an embodiment of the subject matter disclosed herein. In embodiments, the proximal portion 122 of the cannula 104 can have an annular cross-section and is coupled to the adapter 108. For example, the braided mesh 124 can include a plurality of wire elements 140 disposed through a channel of the adapter 108 to interlock the wires of the cannula 104 with the adapter 108, as described in more detail below. In embodiments, the plurality of wire elements 140 can be a plurality of wire loop elements. In embodiments, any of the wire loop elements discussed herein can be replaced with a linear element and / or other wire element. For example, the wire element 140 can be a linear element disposed through a channel of the adapter 108 and secured to the adapter 108 by an interference fit between the adapter 108 and the proximal portion 122 of the cannula 104. In embodiments, element 140 can be welded to adapter 108 and / or otherwise secured to the adapter, for example, with an adhesive, etc. Wire element 140 facilitates attachment of braided mesh 124 to adapter 108 while maintaining a low cross-sectional profile relative to proximal portion 122 of cannula 104.

[0036] In some embodiments, the adapter 108 may also be coupled to the ventricular assist device 103, thereby facilitating blood flow through the cannula 104. In some embodiments, the adapter 108 may be coupled to the ventricular assist device 103 by welding, soldering, a threaded fit, or the like.

[0037] Figure 4 is not intended to suggest any limitations on the scope of use or functionality of the embodiments of the present disclosure, nor should it be interpreted as having any dependency or requirement regarding any single component or combination of components shown therein. Moreover, the various components shown in Figure 4 can be combined in embodiments with various of the other components shown therein (and / or components not shown), all of which are considered to be within the scope of the present disclosure.

[0038] FIG. 5A illustrates a perspective view of an exemplary adapter 200, and FIG. 5B illustrates a side view of an exemplary adapter 200 with a wire element coupled thereto, according to an embodiment of the subject matter disclosed herein. Similar to the adapter 108, the adapter 200 can secure a cannula (e.g., the cannula 104) to a circulatory assist device (e.g., the circulatory assist device 102). As illustrated, the adapter 200 can have a generally annular cross-sectional profile with an inner diameter capable of receiving a circulatory assist device. In embodiments, the inner diameter of the adapter 200 can be configured to receive circulatory assist devices of different sizes. For example, the inner diameter of the adapter 200 can range from 0.167 inches to 0.185 inches. In other examples, the inner diameter of the adapter 200 can be less than 0.167 inches. In yet other examples, the inner diameter of the adapter 200 may be greater than 4.699 millimeters (0.185 inches).

[0039] In the illustrated embodiment, the adapter 200 also includes a number of channels 202 circumferentially disposed 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 that extends 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 channels 202. In some embodiments, the post 208 may secure a loop element of a cannula (e.g., the cannula 104) to the adapter 200. For example, as shown in FIG. 5B, a wire of the cannula may be disposed through a first channel 202 of the channels 202, around the proximal end 212 of the post 208, and through a second channel 202 of the channels 202 to form a wire loop 214. When the adapter 200 is coupled to the circulatory assist device 102 , the post 208 can provide an interference fit with the circulatory assist device 102 to prevent the wire loop 214 from being pulled out of the adapter 200 .

[0040] FIG. 6A illustrates a perspective view of another exemplary adapter 300 according to an embodiment of the subject matter disclosed herein, and FIG. 6B illustrates a side view of the exemplary adapter 300 with a wire element coupled thereto according to an embodiment of the subject matter disclosed herein. Similar to the adapter 108, the adapter 300 can secure a cannula (e.g., the cannula 104) to a circulatory assist device (e.g., the circulatory assist device 102). As illustrated, the adapter 300 can have a generally annular cross-sectional profile with an inner diameter capable of receiving a circulatory assist device. In embodiments, the inner diameter of the adapter 300 can be configured to receive circulatory assist devices of different sizes. For example, the inner diameter of the adapter 300 can range from 0.167 inches to 0.185 inches. In other examples, the inner diameter of the adapter 300 can be less than 0.167 inches. In yet other examples, the inner diameter of the adapter 300 may be greater than 4.699 millimeters (0.185 inches).

[0041] In embodiments, the adapter 300 can include a distal cylindrical portion 302 and a proximal cylindrical portion 304. In embodiments, the adapter 300 can also include a plurality of elongate members 306 extending between the distal cylindrical portion 302 and the proximal cylindrical portion 304. Additionally or alternatively, a groove 308 extending through the thickness of the adapter 300 can separate each of the elongate members 306. In embodiments, the distal cylindrical portion 302, the proximal cylindrical portion 304, and the plurality of elongate members 306 can be a monolithic member. Alternatively, the distal cylindrical portion 302, the proximal cylindrical portion 304, and / or the plurality of elongate members 306 can be separate members.

[0042] In embodiments, the adapter 300 includes a number of channels 310 circumferentially disposed on an inner surface 312 of the distal cylindrical portion 302, the proximal cylindrical portion 304, or both. In the illustrated embodiment, the channels 310 can 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] 6B, the channel 310 and / or the elongate member 306 can prevent a loop element of a cannula (e.g., cannula 104) from being pulled out of the adapter 300. For example, a wire of the cannula can be placed through a first channel 310 of the plurality of channels 310, around the elongate member 306, and through a second channel 310 of the plurality of channels 310 to form a wire loop 318. Placing the wire loop 318 around the elongate member 306 can prevent the wire loop 318 from being pulled out of the adapter 300.

[0044] FIG. 7A illustrates a perspective view of yet another exemplary adapter 400 according to an embodiment of the subject matter disclosed herein, and FIG. 7B illustrates a side view of the exemplary adapter 400 including a wire loop according to an embodiment of the subject matter disclosed herein. Similar to the adapter 108, the adapter 400 can secure a cannula (e.g., the cannula 104) to a circulatory assist device (e.g., the circulatory assist device 102). As shown, the adapter 400 can have a generally circular cross-sectional profile with an inner diameter capable of receiving the circulatory assist device. In embodiments, the inner diameter of the adapter 400 can be configured to receive circulatory assist devices of different sizes. For example, the inner diameter of the adapter 400 can range from 0.167 inches to 0.185 inches. In other examples, the inner diameter of the adapter 400 can be less than 0.167 inches. In yet other examples, the inner diameter of the adapter 400 may be greater than 4.699 millimeters (0.185 inches).

[0045] In embodiments, the adaptor 400 can include a distal cylindrical portion 402 and a proximal cylindrical portion 404. In embodiments, the adaptor 400 can also include a plurality of elongate members 406 extending between the distal cylindrical portion 402 and the proximal cylindrical portion 404. Additionally or alternatively, a groove 408 extending through the thickness of the adaptor 400 can separate each of the elongate members 406. In embodiments, the distal cylindrical portion 402, the proximal cylindrical portion 404, and the plurality of elongate members 406 can be a monolithic member. Alternatively, the distal cylindrical portion 402, the proximal cylindrical portion 404, and the plurality of elongate members 406 can be separate members.

[0046] In some embodiments, the adapter 400 includes a number of channels 410 circumferentially disposed on an inner surface 412 of the distal cylindrical portion 402, the proximal cylindrical portion 404, or both. In the illustrated embodiment, the channels 410 can 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 along only a portion of the length 416 of the proximal cylindrical portion 404, the proximal cylindrical portion 404 can have a relatively larger diameter disposed near a proximal end 418 of the adapter 400. Thus, a larger diameter circulatory assist device can be accommodated by the adapter 400 as compared to an embodiment in which the channels 410 extend along the entire length 416 of the proximal cylindrical portion 404. Alternatively, if the same size circulatory assist device is used in the two embodiments, the adapter 400 can have a smaller cross-sectional profile than if the adapter 400 included a channel 410 extending along the entire length 416 of the proximal cylindrical portion 404.

[0047] 7B, the channel 410 and / or the elongate member 406 can prevent a loop element of a cannula (e.g., cannula 104) from being pulled out of the adapter 400. For example, a wire of the cannula can be placed through a first channel 410 of the plurality of channels 410, around the elongate member 406, and through a second channel 410 of the plurality of channels 410 to form a wire loop 420. Placing the wire loop 420 around the elongate member 406 can prevent the wire loop 420 from being pulled out of the adapter 400.

[0048] FIG. 8 illustrates a perspective view of yet another exemplary adapter 500 in accordance with an embodiment of the subject matter disclosed herein. Similar to adapter 108, adapter 500 can secure a cannula (e.g., cannula 104) to a circulatory assist device (e.g., circulatory assist device 102). As illustrated, adapter 500 can have a generally annular cross-sectional profile with an inner diameter capable of receiving a circulatory assist device. In embodiments, the inner diameter of adapter 500 can be configured to receive circulatory assist devices of different sizes. For example, the inner diameter of adapter 500 can range from 0.167 inches to 0.185 inches. In other examples, the inner diameter of adapter 500 can be less than 0.167 inches. In yet other examples, the inner diameter of adapter 500 can be greater than 0.185 inches.

[0049] In some embodiments, the adapter 500 can include a distal cylindrical portion 502 and a proximal cylindrical portion 504. In some embodiments, the adapter 500 can also include one or more intermediate cylindrical portions 506 extending between the distal cylindrical portion 502 and the proximal cylindrical portion 504. In some embodiments, the distal cylindrical portion 502, the proximal cylindrical portion 504, and the one or more intermediate cylindrical portions 506 can be a monolithic member. Alternatively, the distal cylindrical portion 502, the proximal cylindrical portion 504, and / or the one or more intermediate cylindrical portions 506 can be separate members.

[0050] In embodiments, the adapter 500 includes a plurality of channels 508 circumferentially disposed in the distal cylindrical portion 502. In the illustrated embodiment, the channel 508 can extend along the entire length 510 of the distal cylindrical portion 502. In embodiments, a cannula wire can be positioned through a first channel 508 of the plurality of channels 508, around the proximal end 512 of the distal cylindrical portion 502, and through a second channel 508 of the plurality of channels 508 to form a wire loop that is prevented from being pulled out of the adapter 500.

[0051] FIG. 9 illustrates a perspective view of yet another exemplary adapter 600 in accordance with an embodiment of the subject matter disclosed herein. Similar to adapter 108, adapter 600 can secure a cannula (e.g., cannula 104) to a circulatory assist device (e.g., circulatory assist device 102). As illustrated, adapter 600 can have a generally annular cross-sectional profile with an inner diameter capable of receiving a circulatory assist device. In embodiments, the inner diameter of adapter 600 can be configured to receive circulatory assist devices of different sizes. For example, the inner diameter of adapter 600 can range from 0.167 inches to 0.185 inches. In other examples, the inner diameter of adapter 600 can be less than 0.167 inches. In yet other examples, the inner diameter of adapter 600 can be greater than 0.185 inches.

[0052] In some embodiments, the adapter 600 can include a distal cylindrical portion 602 and a proximal cylindrical portion 604. In some embodiments, the adapter 600 can also include one or more intermediate cylindrical portions 606 extending between the distal cylindrical portion 602 and the proximal cylindrical portion 604. In some embodiments, the distal cylindrical portion 602, the proximal cylindrical portion 604, and the one or more intermediate cylindrical portions 606 can be a monolithic member. Alternatively, the distal cylindrical portion 602, the proximal cylindrical portion 604, and / or the one or more intermediate cylindrical portions 606 can be separate members.

[0053] In embodiments, the adapter 600 includes a plurality of channels 608 circumferentially disposed in the distal cylindrical portion 602. In the illustrated embodiment, the channel 608 can extend along the entire length 610 of the distal cylindrical portion 602. In embodiments, a cannula wire can be positioned through a first one of the channels 608, around the proximal end 612 of the distal cylindrical portion 602, and through a second one of the channels 608 to form a wire loop 614 that is prevented from being pulled out of the adapter 500. In embodiments, the wire loop 614 can be positioned in a trough (directly below the wire loop 614) to prevent lateral movement of the wire loop 614.

[0054] FIG. 10 illustrates a side view of an exemplary mandrel 700 used to form an exemplary cannula, according to embodiments of the subject matter disclosed herein. As illustrated, the mandrel 700 includes a proximal portion 702 to which an adaptor 708 is coupled, an intermediate portion 704, and a distal portion 706. A proximal portion of a wire 712 (shown in FIG. 11) can be placed through a channel in the adaptor 708 to secure and maintain the wire 712 while braiding of the wire 712 is performed. In embodiments, the mandrel 700 also includes a plurality of protrusions 710. As shown in FIG. 11, which illustrates a side view of a distal portion of an exemplary mandrel, designated 700 in FIG. 10, the wire 712 can be wrapped and / or braided around the plurality of protrusions 710 to form the braided mesh (e.g., braided mesh 124) of the cannula (e.g., cannula 104). In embodiments, the intermediate portion 704 can include protrusions 710 having a constant pitch or a varying pitch.

[0055] FIG. 12 illustrates an exemplary mandrel 800 including protrusions 802 having a constant pitch, and FIG. 13 illustrates an exemplary mandrel 900 including protrusions 902 having a variable pitch. In some embodiments, the pitch angle is the angle formed by the two proximal edges of the protrusions and / or the two distal edges of the protrusions. For example, with reference to FIGS. 14A and 14B, two different pitch angles are shown. In FIG. 14A, protrusion 1002 has an edge 1004 that forms a pitch angle of 78 degrees. In comparison, protrusion 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 some 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 can facilitate greater dimetric strength while also facilitating less axial strength. In comparison, a smaller pitch angle can facilitate less dimetric strength while also facilitating greater axial strength. In some embodiments, the dimetric and / or axial strength can be configured for a given application of the cannula and / or selected to withstand pressure gradients between the inside and outside of the cannula.

[0057] Referring again to FIG. 10, intermediate portion 704 can include a tapered portion 714 that can be used to form a tapered proximal portion of the cannula (eg, tapered proximal portion 126).

[0058] In embodiments, once the wire 712 is braided through the prongs 710 to the distal end 716 of the prongs 710, all other wires 712 can be placed in a looped configuration and back through the prongs 710. Wires 712 that are not looped can be placed through a groove 718 in the distal portion 706. In embodiments, once the shape of the wire 712 is formed, the looped portion of the wire 712 or the entire wire 712 can be welded, affixed, stabilized, and / or heat treated to set the shape of the wire 712. The cannula can then be removed from the mandrel 700. After removing the cannula from the mandrel 700, the cannula can be coated with a membrane.

[0059] FIG. 15 illustrates 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 matter disclosed herein. In embodiments, the membrane can be silicone. As shown, the proximal portion 1204 includes a number of proximal wire portions 1206 extending proximally. In at least some embodiments, the proximal wire portions 1206 can extend longitudinally. 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 the circulatory assist device, as described above. In embodiments, the distal portion 1208 includes a number of distal wire portions 1210 extending distally. In at least some embodiments, the distal wire portions 1210 extend longitudinally. As discussed above, these wires 1210 can be coupled to tip elements (eg, tip element 136 discussed above).

[0060] (Additional Note) As a preferred embodiment, the technical ideas that can be understood from the above embodiment will be described below. [Appendix 1] 1. A device attached to a heart pump, comprising: The apparatus includes an adapter, the adapter comprising: an annular cross-sectional portion configured to receive the heart pump and secured to the heart pump; a plurality of channels disposed about the adapter; a distal cylindrical portion; and a proximal cylindrical portion; and A plurality of elongated members; a plurality of elongate members extending from the distal cylindrical portion to the proximal cylindrical portion, and a plurality of grooves extending through a thickness of the adapter separating each of the elongate members; The device comprises 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 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, the plurality of wires being secured to the tip element; the device comprising a coating covering at least a portion of the braided mesh; Device. [Appendix 2] 2. The device of claim 1, wherein the proximal portion of the braided mesh comprises a tapered portion that increases in diameter from the proximal end of the tapered portion to the distal end of the tapered portion. [Appendix 3] 3. The apparatus of claim 1 or 2, wherein the braided mesh has a constant pitch. [Appendix 4] 3. The device of claim 1 or 2, wherein the braided mesh has a varying pitch. [Appendix 5] 4. The apparatus of any one of claims 1 to 3, wherein the channel extends along an inner surface of the adapter. [Appendix 6] 6. The apparatus of claim 5, wherein the channel extends along the entire length of the adapter. [Appendix 7] 7. The device of any one of claims 1 to 6, wherein at least one of the plurality of channels extends in a longitudinal direction. [Appendix 8] 1. A device attached to a heart pump, comprising: The apparatus includes an adapter, the adapter comprising: an annular cross-sectional portion configured to receive the heart pump and secured to the heart pump; a plurality of channels disposed about the adapter; a distal cylindrical portion; and a proximal cylindrical portion; and 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 channel extending through a length of the distal cylindrical portion; The device comprises 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 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, the plurality of wires being secured to the tip element; the device comprising a coating covering at least a portion of the braided mesh; Device. [Appendix 9] 9. The apparatus of any one of claims 1 to 8, wherein the plurality of elements disposed throughout the channel are a plurality of loop elements. [Appendix 10] 2. A method of manufacturing a device according to claim 1, the method comprising: placing proximal ends of a plurality of wires through the plurality of channels of the adapter; braiding the intermediate portions of the plurality of wires to create the braided mesh; extending a distal portion of the plurality of wires in the distal direction; coating at least a portion of the braided mesh with the coating; coupling a distal end of the distal portion to the tip element; A method comprising: [Appendix 11] 11. The method of claim 10, wherein the braided mesh has a constant pitch. [Appendix 12] 11. The method of claim 10, wherein the braided mesh has a variable pitch. Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present disclosure. For example, while the embodiments described above refer to certain features, the scope of the present disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present disclosure is intended to encompass all such alternatives, modifications, and variations that are within the scope of the claims, together with all equivalents thereof.

Claims

1. 1. A circulatory assist device comprising: The circulatory assist device comprises a heart pump; The circulatory assist device comprises a cannula having a proximal portion, an intermediate portion, and a distal portion, the proximal portion coupled to and extending distally from the heart pump; the intermediate portion comprises a braided mesh formed from a plurality of wires extending between the proximal portion and the distal portion; the circulatory assist device includes an adapter coupling the plurality of wires to the heart pump. Circulatory support device.

2. The circulatory assist device of claim 1 , wherein the adaptor comprises an annular cross-section and a plurality of channels disposed about the adaptor.

3. The circulatory assist device of claim 2 , wherein the adapter is configured to surround the heart pump.

4. 4. The circulatory assist device of claim 2 or 3, wherein the plurality of channels extend along the entire length of the adapter.

5. The circulatory assist device of claim 4 , wherein the plurality of wires are disposed in a plurality of channels.

6. The circulatory assist device of claim 5 , wherein the plurality of wires are welded to the adapter.

7. 4. The circulatory assist device of claim 2 or 3, wherein the plurality of channels extend along an inner surface of the adapter.

8. The circulatory assist device of claim 7 , wherein the plurality of wires are welded to the adapter.

9. The circulatory assist device of claim 1 , wherein the braided mesh comprises a varying pitch.

10. The circulatory assist device of claim 1 , wherein the braided mesh comprises a constant pitch.

11. The circulatory assist device of claim 1 , wherein the plurality of wires extend distally from the braided mesh to a distal end thereof.

12. 4. The circulatory assist device of any one of claims 1 to 3, wherein the proximal portion comprises a tapered portion, the tapered portion increasing in diameter from a proximal end of the tapered portion to a distal end of the tapered portion.

13. The circulatory assist device of any one of claims 1 to 3, wherein the braided mesh is configured to expand from a delivery configuration to a deployed configuration.

14. 14. The circulatory assist device of claim 13, wherein the braided mesh in the deployed configuration has a diameter of 5 millimeters or greater.

15. The circulatory assist device of any one of claims 1 to 3, further comprising a coating covering at least a portion of the braided mesh.

16. 1. A circulatory assist device comprising: The circulatory assist device comprises a heart pump; The circulatory assist device comprises a distal tip; the circulatory assist device comprises a cannula extending between the cardiac pump and the distal tip; the cannula comprises a braided mesh formed from a plurality of wires; The circulatory assist device includes an adapter configured to couple the cannula to the heart pump, the adapter including a plurality of channels extending along an inner surface of the adapter; the wires are provided in the channels for securing the cannula wires to the heart pump; Circulatory support device.

17. The circulatory assist device of claim 16 , wherein the braided mesh comprises a varying pitch.

18. 17. The circulatory assist device of claim 16, wherein the braided mesh comprises a constant pitch.

19. 17. The circulatory assist device of claim 16, wherein the plurality of wires are welded to the adapter.

20. 20. The circulatory assist device of any one of claims 16 to 19, wherein the plurality of channels extend along the entire length of the adaptor.

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