Inlet / outlet cannula

Abstract

Various aspects of this disclosure relate to apparatuses, systems, and methods that may include inflow or effluent cannulation devices. An inflow or effluent cannulation device may include a conduit having an outer surface and an inner surface; an inlet portion disposed at a first end of the conduit, the inlet portion including a plurality of elongated members disposed around the periphery of the inlet portion and configured to unfold against a tissue wall; and a graft portion covering and disposed between the plurality of elongated members and extending along the inner surface of the conduit.

Description

[0001] Cross-reference to related applications

[0002] This application claims the benefit of provisional patent application No. 62 / 969824, filed on February 4, 2021, the full text of which is incorporated herein by reference for all purposes. Technical Field

[0003] This disclosure relates generally to medical devices, and more specifically to inflow or outflow cannulas that may include tissue anchoring elements. Background Technology

[0004] Cannulation can create flow channels within a patient's body. For example, cannulation can be used to create flow channels into and out of organs such as the heart. Cannulation can be used to create inflow or outflow channels from the heart. In some cases, cannulation can be used in cardiac assist procedures to create inflow channels from the heart to increase blood flow from the heart to assist the patient's circulation. Anchoring structures can be used to place cannulation within organs such as the heart. Summary of the Invention

[0005] According to one example (“Example 1”), an inflow or outflow cannulation device includes: a conduit having an outer surface and an inner surface; an inlet portion disposed at a first end of the conduit, the inlet portion including a plurality of elongated members disposed around the periphery of the inlet portion and configured to spread against a tissue wall; and a graft portion covering the plurality of elongated members and disposed between the plurality of elongated members and extending along the inner surface of the conduit.

[0006] According to another example (“Example 2”) that goes further than the device in Example 1, the graft portion is disposed on the outer and inner surfaces of a plurality of elongated members.

[0007] According to another example (“Example 3”) that goes further than any of the devices in Examples 1-2, the graft portion is disposed along the inner surface of a plurality of elongated members and extends along the inner surface of the conduit to a second end of the conduit.

[0008] According to another example (“Example 4”) that goes further than the device in Example 3, the graft portion extends along the outer surface of a plurality of elongated members.

[0009] According to another example (“Example 5”) that goes further than any of the devices in Examples 1-3, the entry portion is configured to conform to the tissue wall and reduce its tissue erosion.

[0010] According to another example (“Example 6”) that goes further than any of the devices in Examples 1-5, the outer surface of the conduit is configured to reduce thrombus formation.

[0011] According to another example (“Example 7”) that is a further device relative to any of Examples 1-6, the inlet portion includes a funnel shape in the initial configuration and is configured to flatten (press) against the tissue wall and unfold.

[0012] According to another example (“Example 8”) that goes further than any of the devices in Examples 1-7, the device also includes a restraint ring arranged around a plurality of elongated members to maintain the inlet portion in a substantially cylindrical configuration and to allow the inlet portion to be released against the tissue wall to flatten (flatten) and unfold.

[0013] According to another example (“Example 9”) that goes further than the device in Example 8, the restraint ring is configured to slide away from the first end of the conduit in response to contact with the epicardial surface of the heart to allow release of the inlet portion.

[0014] According to another example (“Example 10”) that goes further than any of the devices in Examples 1-9, the device also includes a plurality of ring structures disposed along the outer surface of the outflow portion of the pipe.

[0015] According to another example (“Example 11”) that goes further than any of the devices in Examples 1-10, the inlet portion is configured to expand against the tissue wall in response to the fluid flow pressure of the heart chamber.

[0016] According to another example (“Example 12”) that goes further than any of the devices in Examples 1-10, the conduit includes an adjustable cannula portion having a threaded surface and a stop, and the stop is configured to travel along the length of the threaded surface to adjust the position of the inlet portion relative to the tissue wall.

[0017] According to one example (“Example 13”), an anchoring structure for inlet or outlet cannula includes: an inlet portion including a plurality of elongated members disposed around the periphery of the inlet portion and configured to spread against a tissue wall; an outlet portion disposed distal to the inlet portion and including an outer surface and an inner surface; and a graft portion covering the plurality of elongated members and disposed between the plurality of elongated members and extending along the inner surface of the outlet portion.

[0018] According to another example (“Example 14”) that goes further than the anchoring structure of Example 13, the inlet portion includes a funnel shape in the initial configuration and is configured to flatten (press) against the tissue wall and unfold.

[0019] According to another example (“Example 15”) that goes further than any of the anchoring structures in Examples 13-14, the graft portion is disposed on the outer and inner surfaces of a plurality of elongated members.

[0020] According to another example (“Example 16”) that goes further than any of the anchoring structures in Examples 13-15, the graft portion is disposed along the inner surface of a plurality of elongated members and extends along the inner surface of the outflow portion, and the graft portion extends along the outer surface of the plurality of elongated members.

[0021] According to another example (“Example 17”) that goes further than any of the anchoring structures in Examples 13-16, the inlet portion is configured to unfold against the tissue wall in response to the fluid flow pressure of the heart chamber.

[0022] According to one example (“Example 18”), a method of anchoring a cannula within a patient’s heart includes: setting an anchoring structure in a delivery configuration, the anchoring structure including a plurality of elongated members and a graft portion covering the plurality of elongated members and disposed between the plurality of elongated members; moving the anchoring structure within the heart; and allowing the anchoring structure to expand from the delivery configuration and unfold against a tissue wall.

[0023] According to another example (“Example 19”) that goes further than the method of Example 18, the method also includes setting constraint rings around a plurality of elongated members to maintain the anchoring structure in the delivery construction.

[0024] According to another example (“Example 20”) that goes further than the method of Example 19, the movement of the anchoring structure within the heart causes the restraint ring to slide around a plurality of elongated members, thereby allowing the release of the anchoring structure to flatten and unfold against the tissue wall in response to the fluid flow pressure within the heart chamber.

[0025] According to another example (“Example 21”) that goes further than the method of Example 20, moving the anchoring structure includes forcing the constraint ring against the epicardial surface of the heart to allow the release of the anchoring structure.

[0026] According to another example (“Example 22”) that goes further than the method of Example 18, the conduit includes an adjustable cannula portion having a threaded surface and a stop, the stop being configured to travel along the length of the threaded surface, and the method further includes adjusting the stop along the threaded surface to adjust the position of the inlet portion relative to the tissue wall.

[0027] According to one example (“Example 23”), a method for reducing thrombosis associated with a ventricular assist device includes: placing an anchoring structure within a patient’s heart, the anchoring structure including a plurality of elongated members and a graft portion covering and disposed between the plurality of elongated members; and pumping blood through the anchoring structure and through a conduit coupled to the anchoring structure.

[0028] The foregoing examples are merely illustrative and should not be construed as limiting or otherwise narrowing the scope of any inventive concept otherwise provided by this disclosure. Although several examples have been disclosed, other examples will become apparent to those skilled in the art from the following detailed description, which illustrates and describes illustrative examples of the invention. Therefore, the drawings and detailed description should be considered illustrative in nature and not restrictive in nature. Attached Figure Description

[0029] The accompanying drawings are included to provide a further understanding of the present disclosure, and the drawings are incorporated in and form a part of this specification, illustrating embodiments and, together with the description, serving to explain the principles of the present disclosure.

[0030] Figure 1 These are illustrations of example anchoring structures based on various aspects of this disclosure;

[0031] Figure 2A-2D It is an example cut pattern of the entry portion according to various aspects of this disclosure;

[0032] Figure 3 These are illustrations of example cannulation based on various aspects of this disclosure;

[0033] Figure 4 This is an illustration of an example inlet portion disposed within cardiac tissue according to various aspects of this disclosure;

[0034] Figure 5 These are example systems including inlet cannulas, outlet cannulas, and pumps, based on various aspects of this disclosure;

[0035] Figure 6A This is a side view of an example entry portion and constraint ring of a delivery structure according to various aspects of this disclosure;

[0036] Figure 6B It is in the delivery structure according to various aspects of this disclosure Figure 6A A top view of the entrance section and constraint ring shown;

[0037] Figure 6C It is in the second construction according to various aspects of this disclosure. Figures 6A-6B The side view of the entrance section and constraint ring shown;

[0038] Figures 7A-7C It is an illustration of the cutting pattern of the entrance portion according to various aspects of this disclosure;

[0039] Figure 8A This is a side view of an example cannula and inlet portion according to various aspects of this disclosure;

[0040] Figure 8BBased on all aspects of this disclosure Figure 8A A top view of the entrance section shown;

[0041] Figure 9A This is a side view of another example cannula and inlet portion according to various aspects of this disclosure;

[0042] Figure 9B Based on all aspects of this disclosure Figure 9A A top view of the entrance section shown;

[0043] Figure 10A This is a side view of another example cannula and inlet portion according to various aspects of this disclosure;

[0044] Figure 10B Based on all aspects of this disclosure Figure 10A A top view of the entrance section shown;

[0045] Figure 11 This is a perspective view of an adjustable cannula portion exemplified according to various aspects of this disclosure;

[0046] Figure 12A This is a side view of an exemplary adjustable cannula portion and inlet portion in a first configuration according to various aspects of this disclosure; and

[0047] Figure 12B It is in the second construction according to various aspects of this disclosure. Figure 12A The side view of the adjustable cannula section and the inlet section shown. Detailed Implementation

[0048] Definitions and Terms

[0049] This disclosure is not intended to be read in a restrictive manner. For example, the terms used in this application should be read broadly in the context of their meanings to be attributed to those skilled in the art.

[0050] Regarding imprecise terminology, the terms "about" and "approximately" are used interchangeably to refer to a measurement that includes the stated measurement value as well as any measurement value that is reasonably (comparably) close to the stated measurement value. As understood and readily determined by one of ordinary skill in the art, a measurement value reasonably close to the stated measurement value deviates from the stated measurement value by a reasonably small amount. Such deviations can be attributed to, for example, measurement errors, differences in measurement values ​​and / or manufacturing equipment calibration, human errors in reading and / or setting the measurement value, fine-tuning to optimize performance and / or structural parameters taking into account differences in measurement values ​​related to other components, specific implementation scenarios, imprecise adjustments and / or manipulations of the object by humans or machines, and / or the like. Where it is determined that such a reasonably small difference value would not be readily determined by one of ordinary skill in the art, the terms "about" and "approximately" can be understood as the value plus or minus 10%.

[0051] Description of various embodiments

[0052] Those skilled in the art will readily understand that various aspects of this disclosure can be implemented by any number of methods and apparatuses configured to perform the intended functions. It should also be noted that the accompanying drawings referenced herein are not necessarily drawn to scale, but may be enlarged to illustrate various aspects of this disclosure, and in this regard, the drawings should not be construed as limiting.

[0053] Various aspects of this disclosure relate to devices, systems, and methods that can be used to improve or assist cardiac function. The disclosed devices, systems, and methods generally include an anchoring structure or inlet portion of a cannula that can be placed within the patient's heart. The disclosed anchoring structure or inlet portion of the cannula can be used in conjunction with a pump system to increase blood flow within the patient.

[0054] Figure 1 This is an illustration of an example anchoring structure 100 according to various aspects of this disclosure. The anchoring structure 100 can be used for inlet or outlet cannulas. The anchoring structure 100 includes an inlet portion 102 comprising a plurality of elongated members 104 disposed around the periphery of the inlet portion 102. The plurality of elongated members 104 are configured to spread against tissue walls (e.g., as shown in the diagram). Figure 4 (As shown).

[0055] The anchoring structure 100 also includes an outflow portion 106, which is disposed distal to the inflow portion 102 and includes an outer surface and an inner surface. For example... Figure 1As shown, the graft portion 108 may cover and be disposed between a plurality of elongated members 104. Furthermore, the graft portion 108 extends along the inner surface of the outflow portion 106. The graft portion 108, disposed along the interior of the inflow portion 102 and the outflow portion 106, reduces thrombus formation along the inner surface. When the anchoring structure 100 is disposed within the patient, the inner surface is an internal lumen surface for blood flow. The graft portion 108, extending along the inner surfaces of the inflow portion 102 and the outflow portion 106, reduces surface disturbance along the blood flow surface of the anchoring structure 100.

[0056] In some cases, the graft portion 108 may also extend around the distal end of the inlet portion 102 and cover the outer surface of the inlet portion 102. In other cases, a second graft portion or layer may extend to cover the outer surface of the inlet portion 102. The graft portion 108 may extend between and within the spaces of the plurality of elongated members 104. In some cases, the graft portion 108 may be configured to stretch and recover (recover) in response to forces acting on the graft portion 108. Stretching can promote compliance. For further discussion of the material properties of the graft portion 108, reference may be made to U.S. Patent No. 4,877,661 (“House et al.”), which is incorporated herein by reference.

[0057] As shown, the inlet portion 102 may include a funnel shape in its initial configuration. In some cases, the shape of the plurality of elongated members 104 may be configured as a funnel shape. The inlet portion 102 may be configured to flatten against (lay flat on) the tissue wall and expand. In some cases, the inlet portion 102 may be configured to expand against the tissue wall in response to the fluid flow pressure of the heart chambers.

[0058] As discussed in further detail below, the anchoring structure 100 may be provided with an outflow or inflow cannula and connected to a pump. The anchoring structure 100 can contact the tissue wall of the patient's heart and stabilize the cannula. The anchoring structure 100 is configured to contact and conform to the tissue wall and provide an inlet for blood flow out of the heart. The anchoring structure 100 can reduce stagnation and thrombosis by maintaining contact with the tissue wall, as discussed in further detail below. A plurality of elongated members 104 can stabilize the anchoring structure 100 and the graft portion 108 can cover the entirety of the plurality of elongated members 104 to reduce tissue erosion.

[0059] Figure 2A-2D This is an example cut pattern of the entry portion according to various aspects of this disclosure. Multiple elongated members 104 may be made from... Figures 2A-2DAny one or a combination of the cutting patterns shown may be formed. The plurality of elongated members 104 may be formed from a flat sheet or tube of nitinol (NiTi). In some cases, the plurality of elongated members 104 may be formed from a polymeric material or a different biocompatible metal such as stainless steel. The plurality of elongated members 104 may include a non-invasive distal end 210. The distal end 210 of each of the plurality of elongated members 104 may be curved.

[0060] Furthermore, the pattern (style) forming multiple elongated components 104 can form an entrance portion or an anchoring structure, such as... Figure 1 and 3 As shown, for example, the number of the plurality of elongated members 104 can be as follows: Figure 2A-2D The changes are as shown. For example, Figure 2A The pattern shown includes 16 elongated components 104, and Figure 2B The pattern shown includes eight elongated members 104. The pattern can be formed to include any number of elongated members 104, such as 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 or somewhere in between.

[0061] Furthermore, as shown in the figure, the pattern includes a shoulder portion 212 from which multiple elongated members 104 extend. (Compare...) Figure 2A As shown in the pattern in -D, the height or length can vary. Furthermore, as compared... Figure 2A-2D As shown in the pattern, the spacing between the elongated members 104 can vary. The thickness of the tube or flat sheet used to form the elongated members 104 can be between 0.2 and 0.5 mm. Furthermore, as... Figure 1 and 3 As shown, these patterns can be formed into funnel structures to include an outer diameter of approximately 10 mm to 20 mm. The three-dimensional form of the patterns is, for example, in... Figures 7A-7C As shown in the image.

[0062] Figure 3 This is an illustration of an example cannula 320 according to various aspects of this disclosure. The cannula 320 can be used as an inflow or outflow cannula. The cannula 320 may include a conduit 322 having an outer surface and an inner surface. The cannula 320 may also include an inlet portion 102 disposed at a first end of the conduit 322. The inlet portion 102 may include a plurality of elongated members 104 disposed around the periphery of the inlet portion 102, these elongated members 104 being configured to unfold against (unfold on) a tissue wall.

[0063] The cannula 320 may also include a graft portion 108 that covers and is disposed between the multiple elongated members 104 and extends along the inner surface of the conduit 322. In some cases, the graft portion 108 is disposed on both the outer and inner surfaces of the multiple elongated members 104. Furthermore, the graft portion 108 may be disposed along the inner surface of the multiple elongated members 104 and extend along the inner surface of the conduit 322 to a second end 106 (or outflow portion) of the conduit. The graft portion 108 may also extend along the outer surface of the multiple elongated members 104.

[0064] The inlet portion 102 can contact the tissue wall of the patient's heart and stabilize the cannula 320. With the aid of elongated members 104 and graft portion 108, the inlet portion 102 can be configured to contact and conform to the tissue wall, providing an entry point for blood flowing out of the heart. The inlet portion 102 reduces stagnation and thrombosis by maintaining contact with the tissue wall without extending into the heart. Multiple elongated members 104 can stably anchor the structure 100, and the graft portion 108 can cover the entirety of the multiple elongated members 104 to reduce tissue erosion.

[0065] As shown in the figure, the inlet portion 102 includes a funnel shape in its initial structure and is configured to flatten against the tissue wall (lay flat on the tissue wall) and unfold (e.g., as shown in the figure). Figure 4 (As shown). The inlet portion 102 is configured to expand against the tissue wall in response to the fluid flow pressure of the heart chamber (expand on the tissue wall). Furthermore, as described above, the graft portion 108 may be disposed along the inner surface of a plurality of elongated members 104 and extend along the inner surface of the conduit 322. The graft portion 108 disposed along the interior of the inlet portion 102 and the conduit 322 can reduce thrombus formation along the inner surface. The inner surface is the luminal surface of blood flow within the cannula 320. The graft portion 108 extending along the inner surface of the inlet portion 102 and the conduit 322 can reduce surface disturbance along the blood flow surface of the cannula 320.

[0066] Multiple ring structures 324 may be provided along the outer surface of the outflow portion 106 of the conduit 322. The multiple ring structures 324 may be made of a biocompatible nonmetallic material, such as dense ePTFE. For further discussion of dense ePTFE, references can be made to U.S. Patent Nos. 5,843,171 (“Campbell et al.”) and 5,747,128 (“Campbell et al.”), which are incorporated herein by reference. The multiple ring structures 324 may enhance the torsional resistance and circumferential strength of the outflow portion 106 of the conduit 322.

[0067] In some cases, graft portion 108 may include a coating configured to minimize thrombotic reactions that may occur due to exposure of graft portion 108 to blood contact. In some cases, the coating may be a heparin coating. The heparin coating is used to bind heparin molecules to graft portion 108. Further discussion of heparin-coated graft portions 108 can be found in the specific teachings of U.S. Patent No. 6,461,665 (“Scholander”) regarding the antithrombotic activity of surface-immobilized heparin, which is incorporated herein by reference. In some cases, the heparin coating may be Bioactive surfaces ( BioActive Surface)( (Heparin surface).

[0068] In some cases, the heparin coating can be applied to the graft portion 108 in one or more layers. The chemical composition of the covering material in each layer can be the same or different. In some cases, the covering material is crosslinked with itself or other covering materials in other layers. The crosslinking bonds can be covalent or ionic. The heparin covering can be formed in at least one layer on at least a portion of the graft portion 108 and can be crosslinked to itself or other layers of the covering. The crosslinking can be covalent, ionic, or both. For reference to the application of the heparin layers to the graft portion 108, see U.S. Patent No. 9,399,085 (Cleek et al.), which is incorporated herein by reference.

[0069] In some cases, the graft portion 108 is configured to induce rapid inward tissue growth on at least a portion of its external (tissue contact) surface. In these cases, the construction or material properties of the graft portion 108 covering the outer surface of the entry portion 102 may differ from those of the internal graft portion 108. The graft portion 108 may be different layers of the same graft portion 108, or different second graft portions may be included externally. For inward growth, the graft portion 108 may have a microporous structure that provides a tissue inward growth scaffold for durable occlusion and supplemental anchoring strength for the plurality of elongated members 104.

[0070] In some cases, the cannula 320 may include a connecting section 330. The connecting section 330 can be used to seal and secure the cannula 320 having an opening formed in tissue. For example, when the cannula 320 is placed in the heart, an opening may be formed in the heart (ventricle or atrium). As described above, the inlet portion 102 is located on the inner wall of the heart tissue (again, as...). Figure 4 (As shown). The connecting section 330 can seal the opening and hold the cannula 320 in place. In some cases, a suture can be configured to pass through the connecting section 330 to secure the connecting section 330 to the cardiac tissue.

[0071] Figure 4 This is an illustration of an example inlet portion 102 disposed within cardiac tissue 450 according to various aspects of this disclosure. The inlet portion 102 includes a plurality of elongated members 104, wherein a graft portion 108 is attached to an outer surface (contacting the tissue wall 450) and an inner surface (e.g., Figure 4 As shown above, the graft portion 108 covers the space or gap between the elongated members 104.

[0072] like Figure 4 As shown, the inlet portion 102 contacts the tissue wall 450 in the unfolded configuration. With the aid of elongated members 104 and graft portion 108, the inlet portion 102 can be configured to contact and conform to the tissue wall, providing an inlet for blood flowing out of the heart. The inlet portion 102 can reduce stagnation (retention) and thrombosis by maintaining contact with the tissue wall without extending into the heart. Multiple elongated members 104 can stabilize the anchoring structure 100, and the graft portion 108 can cover the entirety of the multiple elongated members 104 to reduce tissue erosion. In some cases, the tissue wall 450 may be within the heart (e.g., left ventricle, left atrium, right ventricle, right atrium). Furthermore, the anchoring structure 100 may be located within an appendage of the heart (e.g., left atrial appendage).

[0073] Furthermore, as shown in the figure, the graft portion 108 may be disposed along the inner surface of a plurality of elongated members 104 and extend along the inner surface 452 of the conduit 322 to the second end (or outflow portion) of the conduit.

[0074] Figure 5 This is an example system including an inlet cannula 320, an outlet cannula 550, and a pump 200 according to various aspects of this disclosure; as described in detail above, the inlet cannula 320 may include an inlet portion 102 and may be coupled to the pump 200 at an outlet portion 106.

[0075] Pump 200 can typically be any pump 200 configured to drive or otherwise cause blood to flow through pump 200, from inlet portion 102 via cannula 320, and through outflow cannula 550. As shown, outflow cannula 550 may include multiple ring structures 552 to enhance torsional resistance and ring strength, as described above with reference to ring structure 324 on inflow cannula 320. The pump mechanism of pump 200 (also referred to herein as pump driver) can be, for example, a centrifugal pump, axial pump, positive displacement pump, pulsating pump, or other similar devices such as a worm gear drive mechanism or impeller. Pump 200 can be operated to draw blood from the left ventricle (or other heart chambers) and through pump 200.

[0076] In some embodiments, the system further includes a drive wire (drive line) 400. The drive wire 400 is a cable assembly configured to electrically connect a controller 500 located outside the patient's anatomy to the pump 200, or the drive wire 400 may be a rotating drive shaft. As discussed, the drive wire 400 may be guided through the patient's vascular system, then through the skin to its connection point with the controller 500, or to a subcutaneously implanted controller 500. The controller 500 is a module configured to control the operation of the pump 200. The controller 500 may include a battery for controlling the operation of the pump 200. In some cases, the controller 500 may be integrated into the pump 200, such that the system can be configured to operate without the drive wire 400, or without requiring an external extension of the drive wire 400.

[0077] Furthermore, the external control system can be configured to both control the operation of the pump and wirelessly (e.g., via a transdermal energy transfer system) power the pump. In some examples, transdermal energy transfer can be achieved through known methods such as those described in U.S. Patent No. 6,400,991. This configuration eliminates the need to guide the drive wire 400 through the vascular system and out through the percutaneous entry site, which can help minimize the risk of infection. In some examples, the pump 200 may include an "antenna" (or internal coil) configured for transdermal energy transfer ("TET"). In some examples, the external TET component may be worn around the torso, similar to a standard heart rate monitor, and additionally coupled to a power source (wall cell or high-capacity battery), such that the external TET component can operate to transfer energy transdermally to the antenna.

[0078] Figure 6A This is a side view of an example inlet portion 102 and a constraint ring 650 in a delivery configuration according to various aspects of this disclosure. As shown, the inlet portion 102 (which includes a plurality of elongated members 104 and a graft portion 108) is constrained by the constraint ring 650 in the delivery configuration and maintained as a substantially cylindrical configuration / shape. Figure 6B It is in accordance with various aspects of this disclosure and is part of the delivery structure. Figure 6A The top view of the entrance portion 102 and the constraint ring 660 shown.

[0079] The restraint ring 650 may be configured to slide away from the inlet end (e.g., the inlet end) of the conduit 322 in response to contact with the epicardial surface of the heart to allow release of the inlet portion. Figure 6C It is in the second structure, such as Figures 6A-6B The diagram shows a side view of the inlet portion 102 and the constraint ring 650, with the constraint ring 650 slid to release the inlet portion 102. In some cases, the inlet portion 102 (e.g., an anchoring structure) is... Figure 6AThe delivery construct shown is positioned within the patient's heart. An inlet portion 102 (e.g., an anchoring structure) moves within the heart and allows the inlet portion 102 to expand from the delivery construct against a tissue wall. An opening or aperture in the heart (or other tissue) may be formed prior to allowing the inlet portion 102 to move within the heart. In some cases, a restraint ring 650 may contact the outer surface of the heart or organ and slide away from one end of the inlet portion 102, thereby allowing the inlet portion 102 to be released to flatten (press) against a tissue wall and unfold (e.g., as shown) Figure 4 (As shown).

[0080] In some cases, actuating the inlet portion 102 involves forcing the restraint ring 650 against the epicardial surface of the heart to allow release of the inlet portion 102. The opening formed in the heart tissue may be smaller than the outer diameter of the restraint ring 650 to ensure that the restraint ring 650 does not enter the heart. In some cases, an actuator or wire may be attached to the restraint ring 650, allowing a physician to manually actuate the restraint ring 650.

[0081] Figures 8-10 illustrate various configurations of the cannula 320 and the inlet portion 102 consistent with various aspects of this disclosure. The different aspects of the inlet portion 102 between Figures 8-10 generally involve a number of elongated members as described in detail above.

[0082] Figure 11 This is a perspective view of an example adjustable cannula portion 1100 according to various aspects of this disclosure. As discussed in detail above, the adjustable cannula portion 1100 may form part of a cannula 320 (e.g., inflow or outflow). The adjustable cannula portion 1100 may include a stop 1102 movable along the length of the adjustable cannula portion 1100. In some cases, at least a portion of the outer surface of the adjustable cannula portion 1100 may be a threaded surface 1104. The stop 1102 may travel along the length of the threaded surface 1104. The stop 1102 may be positioned along the threaded surface 1104 at a desired location to adjust the amount of the adjustable cannula portion 1100 disposed within the patient's heart.

[0083] In some cases, the inlet portion 102 (as discussed in detail above) may be located at the first end 1106 of the adjustable cannula portion 1100. The conduit 322 (as discussed in detail above) may form part of the adjustable cannula portion 1100 and / or the second end 1108 of the adjustable cannula portion 1100.

[0084] Figure 12A This is a side view of an exemplary adjustable cannula portion 1100 and inlet portion 102 in a first configuration according to various aspects of this disclosure. Figure 12B It is in the second construction according to various aspects of this disclosure. Figure 12ASide view of the adjustable cannula portion 1100 and inlet portion 102 shown. (Compare) Figure 12A and Figure 12B As shown, the stop 1102 can be provided along the threaded surface 1104 along the length of the adjustable insertion portion 1100.

[0085] In some cases, the closer the stop 1102 is to the inlet portion 102, the less the inlet portion 102 is located within the heart. For example, as Figure 12A and Figure 12B As shown, a tissue wall 450 is disposed between the inlet portion 102 and the stop 1102. The closer the stop 1102 is disposed to the inlet portion 102, the less tissue wall 450 is disposed between the inlet portion 102 and the stop 1102. The slope (ramp) of the tissue wall 450 can affect the desired position of the stop 1102 along the threaded surface 1104. An adjustable cannula portion 1100 can facilitate or allow the desired position of the inlet portion 102 so that the cannula does not protrude substantially into the heart. In some cases, a customizable length can help reduce stagnation (retention) and thrombosis by maintaining contact between the inlet portion 102 and the tissue wall without extending into the heart. The stop 1102 can be configured to travel along the length of the threaded surface 1104 to adjust the position of the inlet portion 102 relative to the tissue wall 450. The threaded surface 1104 or other portions of the adjustable cannula portion 1100 and / or the stop 1102 may include locking features (e.g., tabs, friction engagement members) to hold and / or lock the stop 1102 in place along the threaded surface 1104.

[0086] Biocompatible materials, as discussed herein, can be used for graft components. In some cases, the graft may comprise a fluoropolymer, such as polytetrafluoroethylene (PTFE) polymer or expanded polytetrafluoroethylene (ePTFE) polymer. In some cases, the graft may be formed of, for example, but not limited to, polyester, silicone, urethane (polyurethane), polyethylene terephthalate, or another biocompatible polymer or combinations thereof. In some cases, bioabsorbable or bioresorbable materials, such as bioabsorbable or bioresorbable polymers, may be used. In some cases, the graft may comprise polyester, polyolefin, carboxymethyl cellulose fabric, polyurethane, or other woven, nonwoven, or film elastomers.

[0087] In addition, NiTi can be used as a material for frames or scaffolds (and any frames discussed herein), but other materials, such as, but not limited to, stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy (an Elgiloy nonmagnetic alloy), or any other suitable biocompatible materials and combinations thereof, can be used as frame materials. The hyperelasticity and flexibility of NiTi enhance the conformability of the scaffold. Furthermore, NiTi can be shaped to a desired form. That is, NiTi can be shaped such that when the frame is unconstrained, such as when the frame is deployed from a delivery system, it tends to self-expand into the desired shape.

[0088] In some cases, as discussed in detail above, the coating may include bioactive agents other than heparin or heparin alternatives. These agents may include, but are not limited to, vasodilators, anticoagulants, antiplatelet agents, and antithrombotic agents.

[0089] The invention of this application has been described above generally and with reference to specific embodiments. It will be apparent to those skilled in the art that various modifications and alterations can be made to the embodiments without departing from the scope of this disclosure. Therefore, the embodiments are intended to cover modifications and variations of the invention, provided they fall within the scope of the appended claims and their equivalents.

Claims

1. An inflow or outflow cannulation device, the device comprising: A pipe having an outer surface and an inner surface; An inlet portion, located at the first end of the pipe, includes a plurality of elongated members arranged around the periphery of the inlet portion and configured to abut against and conform to the tissue wall, wherein the plurality of elongated members are substantially flat on the tissue wall and extended. as well as The graft portion is disposed on the outer and inner surfaces of the plurality of elongated members such that the graft portion covers the plurality of elongated members and is disposed between the plurality of elongated members, and extends along the inner surface of the conduit.

2. The device as described in claim 1, characterized in that, The graft portion extends along the inner surface of the conduit to a second end of the conduit.

3. The device as described in any one of claims 1-2, characterized in that, The plurality of elongated members are interconnected at the first end and spaced apart from each other at the second end.

4. The device as described in any one of claims 1-2, characterized in that, The inlet portion is configured to reduce tissue erosion of the tissue wall.

5. The device as described in any one of claims 1-2, characterized in that, The outer surface of the pipe is configured to reduce thrombus formation.

6. The device as described in any one of claims 1-2, characterized in that, The inlet portion includes a funnel shape in its initial configuration and is configured to flatten and unfold against the tissue wall.

7. The device as described in any one of claims 1-2, characterized in that, It also includes a constraint ring arranged around the plurality of elongated members to maintain the inlet portion in a substantially cylindrical configuration and allow the inlet portion to be released against the tissue wall to flatten and unfold.

8. The device as claimed in claim 7, wherein, The constraint ring is configured to slide away from the first end of the conduit in response to contact with the epicardial surface of the heart, thereby allowing release of the inlet portion.

9. The device as described in any one of claims 1-2, characterized in that, It also includes multiple ring structures disposed along the outer surface of the outflow portion of the pipe.

10. The device as described in any one of claims 1-2, characterized in that, The inlet portion is configured to expand against the tissue wall in response to the fluid flow pressure within the heart chambers.

11. The device as described in any one of claims 1-2, characterized in that, The conduit includes an adjustable cannula portion having a threaded surface and a stop, and the stop is configured to travel along the length of the threaded surface to adjust the position of the inlet portion relative to the tissue wall.

12. An anchoring structure for inlet or outlet cannulas, comprising: The inlet portion includes a plurality of elongated members disposed around the periphery of the inlet portion, the plurality of elongated members being configured to unfold against and conform to the tissue wall, wherein the plurality of elongated members are substantially flat on the tissue wall and unfolded. An outflow portion is disposed on the distal side of the inlet portion and includes an outer surface and an inner surface; as well as The graft portion is disposed on the outer and inner surfaces of the plurality of elongated members such that the graft portion covers the plurality of elongated members and is disposed between the plurality of elongated members, and extends along the inner surface of the outflow portion.

13. The anchoring structure as described in claim 12, characterized in that, The inlet portion includes a funnel shape in its initial configuration and is configured to flatten and unfold against the tissue wall.

14. The anchoring structure as described in any one of claims 12-13, characterized in that, The inlet portion is configured to expand against the tissue wall in response to the fluid flow pressure within the heart chambers.

Images