Implantable heart pump system comprising improved apex heart connector and / or graft connector

Abstract

Systems and methods for improving the connection between a cardiac pump, such as a left ventricular assist device (LVAD), and the heart and / or a tube, such as a graft tube, are provided herein. A cardiac apex connector is described that includes a cylindrical housing and a ring support connected to the housing. The cardiac apex connector may include a suture ring to be connected to a patient's heart and a spring positioned within the cylindrical housing to engage a portion of the pump and secure the cardiac apex connector to the pump. Alternatively, a cardiac apex connector may include upper and lower housings having a lock positioned in a channel between the housings, and may include a handle and a ring such that the lock engages a portion of the pump. A quick-connect assembly for efficiently connecting a graft tube to an outlet of a heart pump using a flange having a through hole and a protrusion is also described.

Description

[0001] Cross - Reference to Related Applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 383,886, filed on November 15, 2022, and European Patent Application No. 22315288.5, filed on November 15, 2022, the entire contents of each of which are incorporated herein by reference. Technical Field

[0003] The present invention generally relates to implantable heart pump systems, and more particularly to implantable heart pump systems having an apex connector and / or a graft connector. Background Art

[0004] The human heart includes four main chambers having two ventricles and two atria. Generally, the right heart receives deoxygenated blood from the body into the right atrium and pumps it to the lungs via the right ventricle. The left heart receives oxygenated blood from the lungs into the left atrium and pumps it to the aorta via the left ventricle for distribution throughout the body. Due to many different diseases, including coronary artery disease, high blood pressure / hypertension, valvular regurgitation and calcification, damage to the myocardium due to infarction or ischemia, myocarditis, congenital heart disease, arrhythmias, or various infectious diseases, the left ventricle may become less effective and thus unable to pump sufficient oxygenated blood to the whole body.

[0005] For patients who have reached end-stage heart failure, treatment options are limited. In addition to continuing with the drug therapies commonly used during the earlier stages of heart failure, the typical recommendation is either a heart transplant or the implantation of a mechanical assist device. While a heart transplant can significantly extend a patient's life, patients often die while waiting on the waiting list for a suitable donor heart for months and sometimes years. Currently, the only alternative to a heart transplant is a mechanical implant. Although the design of mechanical implants has improved in recent years, typically such implants will extend a patient's life by at most a few years and involve multiple comorbidities.

[0006] One type of mechanical implant commonly used in patients with end-stage heart failure is a left ventricular assist device (LVAD). An LVAD is a surgically implanted pump that draws oxygenated blood from the left ventricle and pumps it directly into the aorta, thereby reducing the pumping workload of the left ventricle. LVADs are typically used as either "bridge-to-transplant" or "destination therapy". When used as bridge-to-transplant, an LVAD is used to extend the life of a patient waiting for a heart transplant. When a patient is not suitable for a heart transplant, an LVAD can be used as destination therapy, meaning definitive treatment for heart failure, to extend the patient's life or improve the patient's quality of life, but typically such extension is only for a few years.

[0007] The surgery for implanting an LVAD is complex and requires a highly skilled surgeon. A coring tool is typically used to perform a ventriculotomy of 1 to 2.5 cm in the apex of the left ventricle and introduce the pump inlet into the heart. The LVAD inlet cannula must be securely fixed to the heart tissue so that the inlet position is maintained within the ventricle during movement and anatomical displacement, including cardiac contraction, respiration, and patient bending. In addition, a graft must be connected from the LVAD to the patient's circulatory system (e.g., the aortic arch). During connection to the pump, the graft is typically prone to twisting, folding, and / or flattening when torsional movement is applied to the graft.

[0008] What is needed are further improved systems and devices for securely and effectively attaching an implantable heart pump (e.g., an LVAD) to the heart and for connecting a graft structure to the patient's circulatory system. SUMMARY OF THE INVENTION

[0009] The present disclosure provides systems and methods for improving the connection between an implantable heart pump (e.g., a left ventricular assist device (LVAD)) and the heart and / or a tube (e.g., a graft tube). For example, an apex connector is described that includes a cylindrical connector housing, a ring support coupled to the housing and having an inner opening with a diameter smaller than the inner opening of the connector housing, and a spring positioned within the inner opening of the housing. The ring support may further include a flange connected to a suture ring for connecting the apex connector to a portion of the patient's heart. The spring may be positioned within the connector housing and may be designed to engage a portion of the heart pump when the heart pump is inserted into the inner opening of the housing to connect the apex connector to the patient's heart.

[0010] Another apex connector is described that has an upper support connected to a lower support and a plurality of channels defined therebetween. The channels guide locks positioned within each channel. Each of the upper support and the lower support may have an inner surface defining a channel extending through the apex connector. A ring may surround the locks and may move the locks within the channels to extend partially beyond the inner surface. When the ring is in a closed position, the locks may engage a portion of the heart pump extending through the channels. The upper support may be connected to a suture ring to connect the apex connector and thus the heart pump to the patient's heart.

[0011] Describe yet another connector for quickly connecting a graft tube or other tube to the outlet of a heart pump or other cannula. The quick-connect assembly may include a connector portion that attaches to one end of the graft tube and has a flange with holes circumferentially distributed around the connector portion, and may further include a connector portion that attaches to one end of the outlet of the pump or other cannula, the connector portion having a set of protrusions for entering the holes in the flange of the connector portion attached to the graft tube. For example, the quick-connect assembly may allow a surgeon or other healthcare provider to quickly connect a graft tube to the outlet of the pump.

[0012] In one example, an assembly for connecting a graft tube to a blood pump includes: a graft assembly designed to couple to one end of the graft tube, the graft assembly forming a cylindrical structure that includes: an inner housing having a first outer surface and a second outer surface; an outer housing offset from the inner housing and defining a graft receiving region between a first inner surface of the outer housing and the first outer surface of the inner housing, and a pump receiving region between a second inner surface of the outer housing and the second outer surface of the inner housing; a flange extending from the cylindrical structure and having a plurality of through-holes circumferentially arranged; and a pump assembly designed to couple to a cannula of the blood pump, the pump assembly including: a cylindrical protrusion sized and designed to be received in the pump receiving region; and a set of protrusions extending from the cylindrical protrusion and designed to be received by and extend through a set of the plurality of through-holes of the flange.

[0013] The cannula may be the outlet of the blood pump, and wherein the cylindrical protrusion is designed to be rotatably coupled to the outlet of the blood pump such that when the cylindrical protrusion is coupled to the outlet of the blood pump, the pump assembly is free to rotate relative to the outlet of the blood pump. The cylindrical protrusion may include a sealing ring designed to form a liquid-tight seal between the graft assembly and the pump assembly. The pump assembly may be designed to rotate relative to the graft assembly when the cylindrical protrusion is received in the pump receiving region and the sealing ring maintains a liquid-tight seal. The pump assembly may further include a set of tabs extending from the set of protrusions, the set of tabs designed to be depressed to cause the set of protrusions to transition between an expanded position and a contracted position. The set of protrusions may be designed to move closer together when the set of tabs is in the contracted position and may be designed to move farther apart when the set of tabs is in the expanded position.

[0014] The set of protrusions can be designed to lock the pump assembly to the graft assembly when the set of protrusions extends through the set of through-holes of the flange. Each protrusion of the set of protrusions can have a first end with a first height and a second end with a second height that is greater than the first height. Each protrusion of the set of protrusions can have a circular profile. The graft receiving region can be designed to receive and couple to the one end of the graft tube to secure the graft assembly to the graft tube.

[0015] In one example, a method for connecting a graft tube to a heart pump via an assembly having a graft assembly and a pump assembly includes: positioning the graft assembly adjacent to the pump assembly, the graft assembly being designed to couple to one end of a graft tube and having a cylindrical structure and a flange extending from the cylindrical structure and having a plurality of through-holes; transitioning a set of tabs on the pump assembly to a compressed state, each of the set of tabs having a protrusion and each extending from the cylindrical protrusion of the pump assembly; with the tabs in the compressed state, aligning the protrusion of each of the tabs with the through-holes of the flange of the graft assembly; and extending the protrusion of each of the tabs through a corresponding one of the plurality of through-holes of the flange by transitioning the set of tabs to a expanded state while the protrusion of each of the tabs is aligned with the through-hole of the flange. When the protrusion of each of the tabs extends through the corresponding through-hole, the cylindrical protrusion can engage the cylindrical structure and be in fluid communication therewith.

[0016] The cylindrical structure of the graft assembly can include an inner housing and an outer housing, and a pump receiving region can be defined between the inner housing and the outer housing. When the protrusion of each of the tabs extends through a corresponding one of the plurality of through-holes of the flange, a portion of the cylindrical protrusion can be received by the pump receiving region. When the protrusion of each of the tabs extends through a corresponding one of the plurality of through-holes of the flange, the cylindrical structure of the graft assembly and the cylindrical protrusion of the pump assembly can form a liquid-tight seal between the graft tube and the cannula.

[0017] The method may further comprise: re-transitioning the set of tabs on the pump assembly to the compressed state; rotating the graft assembly relative to the pump assembly while the set of tabs is in the compressed state and while maintaining the liquid-tight seal between the graft tube and the cannula; and extending the protrusion of each of the tabs through a respective one of the plurality of through-holes of the flange by re-transitioning the set of tabs to the expanded state. The cylindrical protrusion may have a sealing ring, and when the cylindrical protrusion is received by the pump receiving area, the sealing ring may engage both the cylindrical protrusion and the cylindrical structure. The graft receiving area may be defined between the inner housing and the outer housing, and the graft receiving area may be designed to receive the end of the graft tube. The plurality of through-holes of the flange may be circumferentially arranged. Each of the plurality of through-holes may be circular in shape, and the protrusion of each of the tabs may have a circular profile. The protrusions of each of the tabs are positioned closer to each other when the set of tabs is in the compressed state than when each of the tabs is in the expanded state.

[0018] In one example, an apex connector for attaching a heart pump to the apex of a patient's heart includes: a housing having a first end with a first diameter and a second end with a second diameter less than the first diameter, the first end being designed to receive a portion of the heart pump and the second end being designed to engage a cannula of the pump that extends beyond the portion of the pump; a spring having an expandable portion designed to be disposed within the housing and a handle portion designed to extend through an aperture of the housing, the spring being designed to transition from an expanded position to a contracted position about a protrusion of the heart pump; and a suture ring coupled to the housing at the second end, the suture ring being designed to conform to the patient's heart and couple the apex connector to the patient's heart.

[0019] The housing may include a connector housing having the first end and a ring support having the second end, the connector housing being coupled to the ring support. The connector housing may have a plurality of pits designed to facilitate engagement with a support tool. The spring may be designed to be positioned within the connector housing, and the suture ring may be designed to be coupled to the ring support. The apex connector may further include a flange coupled to the housing at the second end and designed to be coupled to the suture ring. The flange may include a plurality of through-holes and may be angled away from the first end. The suture ring may include a silicone layer designed to surround at least a portion of the flange and enter the through-holes. The suture ring may include at least one layer of biocompatible felt and at least one layer of silicone. The suture ring may include a first layer of biocompatible felt, a second layer of silicone, and a third layer of biocompatible felt, the second layer of silicone being positioned between the first layer of biocompatible felt and the third layer of biocompatible felt. The spring may be designed to secure the housing to the heart pump when the spring is in the retracted position.

[0020] An apex connector for securing a heart pump to a patient's heart, the apex connector comprising: an upper support having a first inner surface and a lower surface; a lower support having a second inner surface and an upper surface designed to engage the lower surface of the upper support, the upper surface defining a plurality of channels; a plurality of locks each designed to move in a first direction within a respective one of the plurality of channels toward the second inner surface and selectively extend beyond the second inner surface, the plurality of locks being restricted by the upper support and the lower support from moving in a direction other than the first direction; a lock assembly comprising a ring and a handle, the handle being designed to transition the ring from an open position to a closed position, wherein the closed position of the ring causes the plurality of locks to move in the first direction to partially extend beyond the second inner surface.

[0021] The apex connector may further include a suture ring coupled to the upper support, the suture ring being designed to conform to the patient's heart and couple the apex connector to the patient's heart. The suture ring may be designed to be coupled to the patient's heart via one or more sutures. The suture ring may include silicone inserted between layers of biocompatible felt. The ring may be designed to push the plurality of locks through the respective channels of the plurality of channels such that each of the locks partially extends beyond the second inner surface. Each of the locks of the plurality of locks may be designed to engage a portion of the heart pump when the lock assembly transitions to the closed position to couple the apex connector to the heart pump.

[0022] The ring may include a first end and a second end, and the handle may be designed to rotate about the first end to vary the distance between the first end and the second end of the ring. The handle may include a slot, and the lock assembly may further include an arm that is connected to the second end of the ring at a main end and is designed to engage the slot of the handle at a secondary end. The second inner surface may include a seal ring recessed area, and the apex connector may further include a seal ring that is partially disposed within the seal ring recessed area. The cylindrical housing may have a plurality of pits that are designed to facilitate engagement with a support tool. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] Figure 1 Shows a side view of an exemplary implantable heart pump system including an apex connector, a suture ring, and a pump quick connector.

[0024] Figures 2A to 2E Shows a cross-sectional view and a perspective view of an apex connector including a suture ring, a connector housing, a ring support, and a spring.

[0025] Figures 3A to 3C Shows a top view and a bottom view of an apex connector including a suture ring, a connector housing, a ring support, and a spring, and a perspective view of the spring.

[0026] Figures 4A to 4C Shows a perspective view and a cross-sectional view of a support tube and a graft tube.

[0027] Figures 5A to 5C Shows a view of a graft tube connected to a support tube via a plurality of sutures.

[0028] Figure 6 Shows an antiseptic view of a graft quick connect assembly and a graft assembly.

[0029] Figures 7A to 7B Shows a perspective view of a graft quick connect assembly connected to a graft assembly.

[0030] Figures 8A to 8C Shows a perspective view of a collar cap and a fixed receiver.

[0031] Figures 9A to 9D Shows a perspective view of a collar cap and a graft assembly positioned within a fixed receiver.

[0032] Figure 10 Shows a perspective view of a graft connection assembly, a collar cap, a graft tube, and a support tube.

[0033] Figures 11A to 11D Shows a side view and a cross-sectional view of a graft connection assembly and a pump assembly.

[0034] Figures 12A to 12B Illustrate a perspective view and a cross-sectional view of a punching tool and an apex assembly.

[0035] Figures 13A to 13C Illustrate a perspective view and an exploded view of an apex assembly including a tightening assembly and a locking assembly.

[0036] Figures 14A to 14D Illustrate a perspective view of a heart pump system including a heart pump, an apex connector, a suture ring, a pump quick connector, a graft connection assembly, and a graft quick connector.

[0037] The foregoing and other features of the present invention will become apparent from the following description taken in conjunction with the accompanying drawings and the appended claims. Understanding that these drawings only depict several embodiments in accordance with the present disclosure and should not be considered as limiting its scope, the present disclosure will be described with additional specificity and detail by using the drawings. Detailed Description

[0038] The present invention relates to an implantable heart pump system particularly suitable for a left ventricular assist device (LVAD). The implantable heart pump system may include a pulsatile membrane pump suitable for long-term implantation in a patient with end-stage heart failure. The implantable heart pump may include: an apex connector having a suture ring for securely and effectively fixing the pump inlet to heart tissue; and / or a quick-connect graft connector for effectively connecting a graft to the heart pump in a manner that maintains the integrity of the graft and allows adjustment of the orientation of the graft relative to the pump while maintaining a seal with the pump.

[0039] Now refer to Figure 1 , and illustrate an exemplary implantable heart pump system. As Figure 1 shown, the implantable heart pump system 100 may include a heart pump 102, an apex connector 103, a suture ring 104, a pump quick connector 106, and a graft connection assembly 108. The heart pump 102 may be an implantable heart pump including a pulsatile membrane. For example, the heart pump 102 may be the implantable heart pump described in U.S. Patent No. 10,188,779 and / or U.S. Patent Application Publication No. 2023 / 0338728, the entire content of each of which is incorporated herein by reference. In one example, the heart pump 102 may be an LVAD, but it should be understood that the heart pump 102 may be any type of circulatory assist device.

[0040] The heart pump 102 may include a pump body 116, a pump inlet 112, and a pump outlet 114. The pump body 116 may include a flexible membrane and may move blood from the pump inlet 112 to the pump outlet 114. The pump inlet 112 may be cylindrical in shape and may extend from the top portion of the heart pump 102. The pump inlet 112 may be designed to extend into a blood chamber of the heart (e.g., the left ventricle). The pump outlet 114 may be cylindrical or oval in shape to minimize the pump height and may extend from the bottom portion of the pump 102. The pump outlet 114 may include a pump quick connector 106, which may be designed to quickly and effectively secure a flexible graft to the pump via a graft quick connector 118 extending from a graft connection assembly 108.

[0041] The apex assembly 103 may include a central aperture having an inner diameter greater than the outer diameter of the pump inlet 112. The apex assembly 103 may receive the pump inlet 112 and may rest on and / or be fixed to the top portion of the pump body 102. The apex assembly 103 may be the same as or similar to the Figures 2A to 2D apex assembly 200. The apex assembly 103 may include a suture ring 104, which may be designed to receive the pump inlet 112. The suture ring 104 may be the same as or similar to the Figures 2A to 2D suture ring 204 described in. The suture ring 104 may be made of a biocompatible material and / or may interface with heart tissue. The suture ring 104 may be connected to the heart via one or more sutures that connect the suture ring 104 to heart tissue.

[0042] Now referring to Figures 2A to 2D , the apex assembly 200 will be described. Now referring to Figure 2A , the apex assembly 200 may at least include an apex connector 202 and a suture ring 204. The apex connector 202 may include a connector housing 210, a ring support 212, and a spring 206. In one example, the apex connector 202 may be metallic (e.g., titanium, stainless steel, alloy, etc.). However, it should be understood that the apex connector 202 may be any type of rigid biocompatible material (e.g., plastic). The connector housing 210 may be annular in shape and may include a central aperture having a diameter through which an outlet of the heart pump or other cannula may be received. The connector housing 210 may include a lower lip 216 and an upper lip 218, which may be joined together by a connector body 220. The lower lip 216 may have an inner diameter that may be greater than the inner diameter of the upper lip 218. The connector housing 210 may have a diameter that may be greater than the diameter of the central aperture.

[0043] The spring 206 can be positioned within the connector housing 210, between the lower lip 216 and the upper lip 218. The spring 206 can include a circular portion (e.g., an expandable portion) connected to the tab 205, and the tab 205 can be a handle portion for applying a force to the spring 206 to change the diameter. For example, the tabs 205 can be forced to move together to apply an increased diameter of the spring 206 to allow insertion of the pump inlet. The spring 206 can be designed such that when no force is applied to the tab 205, the spring 206 exerts a constricting force on Figure 1 the outer diameter of the pump inlet 112 (e.g., when the spring 206 transitions from an expanded position to a constricted position). For example, the spring 206 can interface with a protrusion or other part of the heart pump. After the pump is inserted into the heart chamber, applying a force to the tab 205 releases the constricting force of the spring 206 on the pump inlet 112, such that the pump orientation and / or the depth of penetration into the heart chamber can be adjusted based on diagnostic imaging (e.g., echocardiography, fluoroscopy, or other methods). Once the pump inlet has been properly positioned, the force applied to the tab 205 can be released, such that the spring 206 will fix the axial orientation and position of the pump inlet. The tab 205 can include a notch feature to enable the compressive force applied to the tab to pull it together, to be applied by a suture tied between the two tabs. In this embodiment, the suture ties the tabs 205 together, maintaining the spring 206 in an open position to allow insertion of the pump inlet 112. An O-ring or other sealing feature on the pump inlet 112 can temporarily maintain the position of the pump inlet 112 by friction with the inner diameter of the ring support 212. With the temporary connection, the surgeon can adjust the pump position and orientation. Once in the optimal position, the surgeon can cut the suture that ties the tabs 205 together, releasing the restraint on the spring 206, which will then return to its natural conformation and exert a constricting force on the pump inlet 112. The tab 205 can extend outside the connector housing 210 via a window 207 in the connector housing 210. The spring 206 can be designed to transition between an upper portion and a lower portion such that a portion of the spring is positioned near the upper lip 218 and a different portion of the spring is positioned near the lower lip 216 simultaneously. Thus, the spring 206 can be fixed within the connector housing 210.

[0044] The connector housing 210 can be designed to support and / or connect to the ring support 212. For example, the ring support 212 can be connected and / or attached to the apex connector 202 via any well-known connection (e.g., threaded connection, welding, friction fit, etc.). The ring support 212 can be an annular shape and can include a flange 230 extending outward from the ring support 212. The flange 230 can extend around the circumference of the ring support 212 and can include a number of through-holes 232 spaced equidistantly around the flange 230. As Figure 2A shown, the flange 230 can be angled upward and / or can be positioned above the recessed portion of the upper lip 218.

[0045] The suture ring 204 may include a lower layer 241, an intermediate layer 247, and an upper layer 244. The lower layer 241 and / or the upper layer 244 may be of the same or different materials. The lower layer 241 and the upper layer 244 provide a soft fabric interface with the epicardial surface of the heart, have excellent properties for holding sutures, and may promote local hemostasis to reduce the risk of bleeding. For example, the lower layer 241 and / or the upper layer 244 may include a biocompatible felt (e.g., PTFE, polyester, or polyester felt). For example, the intermediate layer 247 may be a flexible layer made of a polymer such as silicone or polyurethane. The intermediate layer 247 may include a material that is harder than the felt to help maintain the position of the pump inlet 112 relative to the heart chamber to which the heart pump is connected. Materials such as silicone and polyurethane generally have poor sutureability and are prone to tearing if force is applied to sutures passing through such materials. However, the felt material alone lacks the mechanical integrity to prevent the heart pump from moving relative to the heart chamber. This may cause the pump inlet 112 to contact the endocardial surface of the heart, which may lead to aspiration of the heart chamber wall, arrhythmias, and even mechanical erosion of the pump inlet 112 into the heart tissue. Figure 2A The multi-layer embodiment shown combines the properties of the felt for sutureability and tissue contact with the mechanical rigidity required to achieve the improved function of the suture ring 204. The suture ring 204 may be made using an overmolding technique, whereby silicone or other polymer is injected or otherwise inserted (e.g., in liquid form) between the upper layer 244 and the lower layer, and allowed to surround the flange 230 and enter the through-hole 232 of the flange 230. The silicone may optionally be cured after insertion and / or injection. In this way, the suture ring 204 may be fixed to the ring support 212. Alternatively or additionally, the suture ring 204 may be fixed to the ring support 212 using any other well-known technique (e.g., sutures).

[0046] As Figure 2A and 2B shown, the suture ring 204 may have a concave or generally concave shape. Since the flange 230 is angled upward, the suture ring 204 may assume a concave shape when the intermediate layer 247 is fixed to the flange 230. It should be understood that the concave shape of the suture 204 may be desirable for suturing or otherwise fixing the suture ring 204 to the heart tissue at the apex of the heart. For example, the apex may be generally spiked or domed in shape, such that the concave shape of the suture ring 204 may receive and / or conform to the generally spiked and / or domed shape of the apex of the heart. It should be understood that the flange may be angled to properly interface the suture angle with the size and shape of the heart anatomy. The suture ring 204 may be cut or trimmed to the desired size by the implanting surgeon based on the size and shape of the patient's heart and the presence of scar tissue, calcification, or other damage in the heart wall, which may affect suture retention or optimal pump orientation and position.

[0047] Now refer to Figure 2B and illustrate a perspective view of the apex assembly 200. As Figure 2B shown, the connector housing 210 may include pits 240 that are equidistantly distributed circumferentially around the outer diameter of the connector housing 210. For example, the pits 240 may each have a radius of curvature and may together form a series of ridges 242. The pits 240 and / or the ridges 242 may be sized and shaped to receive the gripping ends of pliers. In one example, the pliers may be specifically designed to include ends that are sized and shaped to mate with the pits 240. It should be understood that the pliers may be used to grip the apex assembly 200 for implanting the apex assembly and / or the heart pump into the heart. Figure 2B Further illustrate the window 207, which allows the tab 205 to exit the connector housing 210.

[0048] Now refer to Figure 2C and illustrate a perspective cross-sectional view of the apex assembly 200 on the heart pump 250. The heart pump 250 may be the same as or similar to the heart pump 102 of Figure 1 . As Figure 2C shown, the heart pump 250 may include an inlet 223 and a top portion 254, and the top portion 254 may support and / or be connected to the connector housing 210. The inlet 223 may include one or more (e.g., two, three, four, etc.) seal rings 260. For example, the inlet may include a plurality of seal ring recesses (e.g., semi-circular notches) that are designed to receive a portion of the seal ring. The seal rings 260 and / or the corresponding notches may be positioned at different heights along the inlet 223. For example, the seal rings 260 and / or the corresponding notches may be positioned near the bottom of the inlet 223, as Figure 2C shown.

[0049] The seal rings 260 may be any well-known seal rings and / or O-rings, etc. One or more seal rings 260 may interface with the ring support 212 to form a seal that extends 360 degrees to prevent any fluid from escaping or leaking from the heart chamber. The ring support 212 may have a flat and / or smooth inner surface for minimizing contact with the seal rings 260. Although one seal ring 260 may be sufficient to form a seal with the ring support 212, it should be understood that positioning a plurality of seal rings along the inlet 223 provides multiple height options for the apex assembly 200 along the inlet 223. For example, depending on the patient's anatomy, it may be desirable to mate the ring support with a higher or lower seal ring on the inlet 223.

[0050] The pump 250 may include a receiving portion 262 that may extend or otherwise project from the top portion 254 of the heart pump 250. It should be understood that the receiving portion 262 may interface with the spring 206 and / or the connector housing 210 and may have an extended height for better manipulation of the height of the loop support 212 relative to the inlet 223. The receiving portion 262 may be cylindrical and / or annular in shape and may be sized to have an outer diameter received by the inner diameter of the connector housing 210. The outer diameter of the receiving portion 262 may optionally include an upper flange that may be designed to block upward movement of the spring 206 beyond a certain point. The spring 206 may be biased to close (e.g., decrease in diameter) and may thus be biased to clamp or otherwise grip the receiving portion 262. Since the spring 206 is restricted from moving upward relative to the flange 230 and the spring is restricted within the connector housing 210, the spring 206 may fix the connector housing 210 and thus the apex assembly 200 to the heart pump 250. The receiving portion 262 may have a smooth surface to maximize contact with and thus friction with the spring 206.

[0051] Now referring to Figure 2D , a perspective view of the apex assembly 200 is illustrated on the heart pump 250. As shown in Figure 2D , tabs 205 extending from the spring 206 exit the window 207 of the connector housing 210. The tabs 205 may be locked in place such that they cannot move closer to each other to increase the diameter of the spring 206. For example, a lock 266 may be designed to receive both tabs 205 and prevent each tab from moving closer to the other tab. The lock 266 may also be designed to apply a force that displaces the tabs 205 further apart, which in turn increases the constricting force applied by the spring 206 to the outer diameter of the pump inlet 223. A notch feature in the tab 205 that was previously available for applying a suture to maintain the spring 206 in an open position to facilitate pump insertion and optimal positioning may be used as a retaining feature for fixing the lock 266 in place. The lock 266 is inserted onto the tab 205 through a slot in the side of the lock 266. The angular width of the lock 266 relative to the central axis of the apex assembly 200 determines the amount of additional constricting force applied by the spring 206 to the pump inlet 223. By preventing the diameter of the spring 206 from increasing, the lock 266 may lock the spring 206 and thus lock the apex assembly 200 relative to the pump 250 in place.

[0052] Now referring to Figure 2E , a cross-sectional view of the heart pump 250 and the apex assembly 270 is illustrated, the apex assembly 270 may be similar to Figure 2A the apex assembly 200. As with Figure 2ASimilar to the apex assembly 200, the apex assembly 270 may include a suture ring (e.g., suture ring 278) to fix the apex assembly to cardiac tissue. The suture ring 278 may be the same as or similar to the suture ring 204 of Figure 2A and may be flat (as shown in Figure 2E ) or concave (as shown in Figure 2A ). For example, the suture ring 278 may include the same three-layer structure as the suture ring 204 of Figure 2A . The ring support 274 may include a flange with through holes or, alternatively, may include a flange with protrusions for fixing the polymer layer of the suture ring 278 to the ring support 274.

[0053] The ring support 274 may further include a lower recessed portion 280 having an inner diameter greater than the upper inner diameter 281 of the ring support 274 designed to interface with the inlet 223. The lower recessed portion 280 may be designed to receive the spring 272, which may be similar to the spring 206 of Figure 2A and may be designed to clamp or otherwise grip the exterior of the inlet 223. It should be understood that the inlet 223 may alternatively be an outlet of a blood pump (e.g., a heart pump) or any other cannula.

[0054] The ring support 274 may interface with and / or be connected to the connector housing 282 at the bottom portion of the ring support 274. The connector housing 282 may include an opening 286 near the bottom of the connector housing 282, which may include an inner diameter and / or inner surface designed to receive, conform to, and / or mate with the top portion 284 of the heart pump. The connector housing 282 may be connected to the ring support 274 via any well-known connection (e.g., threaded connection, welding, friction fit, etc.). As shown in Figure 2E , the ring support 274 may include a sealing ring 276, which is similar to the sealing ring 260 of Figure 2C but may be positioned in the recessed portion of the ring support 274. Alternatively or additionally, the inlet 223 may include a sealing ring 260 for forming a seal between the ring support 274 and the inlet 223.

[0055] Now referring to Figures 3A to 3B , the apex assembly 300 will be described. The apex assembly 300 may be the same as or similar to the apex assembly 200 of Figure 2A . For example, the apex assembly 300 may include: a suture ring 302, which may be the same as or similar to the suture ring 204 of Figure 2A ; a ring support 304, which may be the same as or similar to the ring support 230; a connector housing 306, which may be the same as that of Figure 2Ais the same as or similar to the connector housing 210; and a spring 308 and a tab 305, which can be the same as or similar to Figure 2A the spring 206 and the tab 205.

[0056] Now referring to Figure 3C , the spring 308 will be described. As Figure 3C shown in, the spring 308 can include a tab 305 for increasing the diameter of the spring 308. The spring 308 can include features 316, 318, and 320. The spring 308 can generally extend along a plane, and the feature 316 can cause the spring 308 to move downward in a direction generally perpendicular to the plane, the feature 318 can cause the spring 308 to move upward in a direction generally perpendicular to the plane, and the feature 320 can cause the spring 308 to move downward in a direction generally perpendicular to the plane. The change in the height of the spring caused by the features 316, 318, and 320 can enable the spring to maintain its position relative to the connector housing in which it is positioned.

[0057] Now referring to Figures 4A to 4C , the support tube 400 will be described. The support tube 400 can provide rigidity and support for at least a portion of a flexible fabric tube (i.e., a graft tube) extending from the outlet of a heart pump. The support tube 400 can be cylindrical in shape and can be made of any well-known biocompatible polymer or plastic. The support tube can be designed to be placed externally to surround a graft tube that can extend from the outlet of the pump to the patient's circulatory system (e.g., the aortic arch). The support tube 400 can be designed to be attached to the pump outlet or the pump body to maintain the axial position of the support tube 400 relative to the graft tube. The graft tube can be made of any well-known fabric and / or polymer material (e.g., polyester or ePTFE).

[0058] The graft tube can be allowed to bend and / or can be flexible. Since the graft tube can be flexible, it may be prone to kinking and / or compression, which may impede blood flow through the graft. The risk of kinking is high near the outlet of the heart pump because the heart pump outlet is rigid, and after connection to the outlet, the graft may immediately redirect upward (e.g., toward the aortic arch), which may cause the graft to crease or kink. To avoid obstruction of blood flow in the graft tube, the support tube can be positioned above the graft tube.

[0059] The support tube 400 may include one or more pleated sections 402, and the one or more pleated sections 402 may have an accordion-like structure. For example, the pleated section 402 may be designed to expand and / or contract in length. The gripping section 404 may be positioned between the pleated sections 402. The gripping section 404 may be in an annular shape and may include a relatively large through hole 406, and the through hole 406 may have a diameter that almost spans the entire length of the gripping section 404. The through hole 406 may be sized such that the fingertips of a user or a surgical instrument can easily interface with the through hole 406 to grip and / or rotate the support tube 400. The gripping section 404 may also be designed to provide strain relief, longitudinal bending, and / or torsion about the longitudinal axis of the support tube 400. The hole 406 may optionally be large enough for a surgeon or other healthcare provider to pinch the graft, or use a surgical instrument to compress or stabilize the graft, to squeeze biological fluid through the graft and / or deliver a needle and / or suture to the graft to remove air or release some biological fluid accumulated within the graft.

[0060] The support tube 400 may further include a connector section 408, and the connector section 408 may be in an annular shape. The connector section 408 may be connected to the graft tube. For example, the connector section 408 may be sutured or otherwise adhered to the graft tube, and the graft tube may be positioned within the inner surface of the support tube 400. In one example, a needle may be positioned through the connector section 408 such that a suture can connect the connector section 408 to the graft tube. The connector section 408 may be connected to a quick-connect mating structure on the outer surface and below the inner surface of the connector section 408, as Figure 6 illustrated in

[0061] Reference Figure 4C , the holes 403 may be positioned along the pleated section 402. For example, four rows of holes 403 may be longitudinally equally spaced along the support tube 400. It should be understood that the holes 403 may be smaller than the holes 406. The holes 403 may allow any fluid of the graft tube collected or exuded on the tube to escape through the holes 403. For example, the graft tube may be a fabric or other semi-porous material, and biological fluid may exude from the graft tube. In the absence of such holes, the biological fluid exuding from the wall of the graft tube may accumulate between the support tube 400 and the graft tube, resulting in compression and blockage of the graft tube.

[0062] Now referring to Figures 5A to 5C , the graft assembly 500 may include a graft tube 502 and a support tube 506. The graft tube 502 may have a diameter smaller than that of the support tube 504 and may be positioned within the support tube 504. The support tube 506 may be the same as or similar to the support tube 400 of Figures 4A to 4C . For example, the support tube 506 may include a gripping section 508, and the gripping section 508 may be the same as Figures 4A to 4Cis the same or similar to the grasping section 404. Additionally, the support tube 506 may include a pleated section 507 (which may be corrugated) and a connector section 510, which may be the same or similar to Figures 4A to 4C the pleated section 402 and the connector section 408 of

[0063] The graft tube 502 may be tubular in shape and may have an accordion structure to facilitate bending, rotation, and torsional movement. In one example, the graft tube 502 may be made of any well-known polymer, fabric, plastic, etc. The graft tube 502 may include one or more lines 512 that longitudinally extend along the graft tube 502. The lines 512 may indicate the degree of twist or rotation of the graft tube 502. For example, a surgeon or other healthcare technician connecting the graft tube to a pump outlet and / or a patient's circulatory system may quickly understand the degree of twist and / or bend of the graft tube 502 by looking at the lines 512. The support tube 504 may be transparent such that the lines 512 are visible through the support tube 504.

[0064] Now referring to Figure 5B and 5C , when the graft tube 502 is positioned within the support tube 504, the first end of the support tube 504 may be sutured to the first end of the graft tube 502. For example, a needle 521 may pierce both the support tube 520 and the graft tube 502 and may be used to connect the graft tube 502 to the support tube 504 using a suture (e.g., suture 530). Alternatively, the graft tube 502 may be connected to the support tube 504 via any other well-known method (e.g., adhesion, melting, sintering, etc.).

[0065] Now referring to Figure 6 , a graft assembly 600 including a support tube 604 and a graft tube 602 may be mated with a graft quick-connect assembly 610, which may be an integral piece or made of several pieces connected (e.g., welded, screwed, or otherwise attached) together. The graft assembly 600, support tube 604, and graft tube 602 may be the same or similar to the graft assembly 500, support tube 504, and graft tube 502 of FIG. 5. The graft quick-connect assembly 610 may include: an internal flange 612; an external flange 614, which may be threaded; an outer surface 616 that includes one or more notches 620; and a connector flange 618, which may include several holes 622 extending therethrough.

[0066] The inner flange 612 may extend within the inner diameter of the graft tube 602, and the outer flange 614 may extend over the outer diameter of the support tube 604. In one example, the support tube 604 may include a connector section 624 that may be sized to frictionally fit between the inner flange 612 and the outer flange 614. The graft quick-connect assembly 610 may be made of metal (e.g., titanium, stainless steel, alloy, etc.) and / or any other material (e.g., plastic) having rigid properties resistant to tensile forces.

[0067] Now referring Figures 7A to 7B to, the collar 715 and the graft assembly 702 and the graft quick-connect assembly 704 are described. The graft assembly 702 and the graft quick-connect assembly 704 may be the same as or similar to Figure 6 the graft assembly 600 and the graft quick-connect assembly 610. The collar 710 may be split into two pieces. The collar 710 may be positioned onto a connector section 708 that may be flat within a length equal to or similar to the length of the collar 710. The collar 710 may include a flange 712 that may extend inwardly from the inner radius of the collar 710.

[0068] Now referring Figure 7B to, the collar 710 is shown positioned onto the graft assembly 702, adjacent to the graft quick-connect assembly 704. As Figure 7B shown in, the collar 710 may form an annular structure that may be positioned on the connector section of the graft support of the graft assembly 702. The flange of the collar 710 may be positioned furthest from the graft quick-connect assembly 704 and may be designed to fill the space between the connector section and the pleated section.

[0069] Now referring Figures 8A to 8C to, the collar cap 800 and the fixing receiver 810 are depicted. The collar cap may be placed over Figure 7B the collar 710. The collar cap 800 may include notches 805 that may be four notches and / or depressions equally spaced around the circumference of the collar cap 800 at the bottom of the collar cap 800. The collar cap 800 may be inserted into the fixing receiver 810 that may have a through-hole with an inner diameter sized to receive the collar cap 800.

[0070] The fixing receiver 810 may include an inner diameter of a through-hole protrusion 815 near the bottom of the through-hole. The protrusion 815 may include four equally spaced protrusions. As Figure 8CAs shown, when the notch 805 of the collar cap 800 aligns with the protrusion 815 of the fixed receiver 810, the collar cap 800 can be sized to fit into the through hole of the fixed receiver 810. The notch 805 can be sized and shaped to receive the protrusion 815 such that the collar cap 800 fits flush with the fixed receiver 810. It should be understood that the fixed receiver 810 can be fixed and / or immovable relative to the collar cap 800. As Figure 8C shown, the collar cap 800 can include a threaded portion 820 that can be positioned at an opposite end of the notch 805, on the inner diameter of the collar cap 800.

[0071] Now referring to Figures 9A to 9C , a graft assembly 902 inserted into a graft quick connect assembly 904 that includes a collar 910 can be inserted into a fixed receiver 912 and a collar cap 900. The graft assembly 902, the graft quick connect assembly 904, and the collar 910 can be the same as or similar to Figures 7A to 7B the graft assembly 702, the graft quick connect assembly 704, and the collar 710. Additionally, the fixed receiver 912 and the collar cap 900 can be the same as or similar to the fixed receiver 810 and the collar cap 800 of FIG. 8.

[0072] As Figure 9B shown, the graft assembly 902, the graft quick connect assembly 904, and the collar 910 can be positioned into the collar cap 900 until the threaded portion 907 of the graft quick connect assembly 904 contacts and / or aligns with the threaded portion of the collar cap 900 (e.g., Figure 8C the threaded portion 820). Now referring to Figure 9C , the graft quick connect assembly 904 can be positioned above the fixed receiver 912 such that the notch 930 of the graft quick connect assembly 904 is exposed and accessible. The socket 940 can be a cylindrical structure having an inner diameter greater than the outer diameter of the graft quick connect assembly 904. The socket 940 can further include a protrusion 945 that can extend inwardly from the inner diameter of the socket 940 and can be designed to fit or otherwise interface with the notch 930 of the graft quick connect assembly 904 such that rotation of the socket 940 causes rotation of the graft quick connect assembly 904.

[0073] Now referring to Figure 9D , the socket 940 can include a receiver for fitting with a wrench for rotating the socket 940 relative to the fixed receiver 912. As the socket 940 rotates relative to the fixed receiver 912, the threads on the graft quick connect assembly (e.g., Figure 9B the threaded portion 907) relative to the threads of the collar cap (e.g., Figure 8CRotate the threaded portion 820) so that the graft quick connect assembly is fixed to the collar cap.

[0074] Now refer to Figure 10 , after applying a wrench to the socket to thread the graft quick connect assembly 1004 to the threads of the collar cap 1000, the graft connection assembly 1050 can be removed from the fixed receiver. As Figure 10 shown, the graft connection assembly 1050 can include the graft quick connect assembly 1004, the collar cap 1000, the graft tube 1022, and the support tube 1044. The graft tube 1022 and the support tube 1044 can be the same as or similar to Figure 6 the graft tube 602 and the support tube 604 of

[0075] Now refer to Figures 11A to 11D , depicting a graft connection assembly 1200 and a pump assembly 1201. The graft connection assembly 1200 can be the same as Figure 10 the graft connection assembly 1050 of Figure 6 . For example, the graft connection assembly 1200, which can form a cylindrical structure, can include a graft tube 1204 and a support tube 1202, and the graft tube 1204 and the support tube 1202 can be the same as Figure 6 the graft tube 602 and the support tube 604 of Figure 6 . The graft tube 1204 can be connected (e.g., via sutures) to the support tube 1202. The support tube 1202 can include a connection section 1206, and the connection section 1206 can be the same as

[0076] As Figure 11AAs shown, the graft quick-connect assembly 1200 may include an inner housing 1203 that includes an outer surface 1207 and an outer surface 1209. The inner housing 1203 may form an inner flange 1224 that may extend into the inner diameter of the graft tube 1204. The inner flange 1224 may include circumferential protrusions to enhance the connection to the graft tube 1204. One end of the graft tube 1204 (e.g., the connection section 1206) may be positioned in a graft receiving region defined between the inner surface 1211 and the outer surface 1207. In one example, the graft tube 1204 may optionally be adhered (e.g., glued) to the inner flange 1224. The inner flange may be transformed into a receiving flange 1212 that may have the same inner diameter as the inner flange 1224 but may have a different outer diameter. The inner diameter of the flange 1224 may be the blood contact portion of the graft quick-connect assembly 1208. Similarly, the inner diameter of the pump outlet 1230 may be the blood contact portion of the pump outlet. It should be understood that the pump outlet 1230 may alternatively be a pump inlet and / or any other cannula of a heart pump or a blood pump. Thus, the lumen surface may include a textured surface designed to hold adherent thrombus or a highly polished surface to prevent thrombus formation. The polished surface may be further enhanced by applying an antithrombotic coating (e.g., diamond-like carbon (DLC), titanium nitride (TiN), or a 2-methacryloyloxyethyl phosphorylcholine (MPC)-based surface treatment). The graft quick-connect assembly 1208 may further include an outer flange 1216 that may have an inner diameter greater than the outer diameter of the receiving flange 1212. The receiving flange 1212 and the outer flange 1216 together may define a receiving channel 1218. The receiving flange 1212 may extend into or otherwise connect to the connector flange 1210, which may include a number of holes extending therethrough.

[0077] A collar 1220 may be positioned over the connection section 1206 and may be two separate pieces. The collar 1220 may be the same or similar to the collar 710 of FIG. 7. The collar 1220 may include a flange 1221 that is the same as the flange 712 and may be positioned in a recessed portion of the support tube 1202 immediately before the connection section 1206. The collar cap 1222 may be the outer housing of the graft quick-connect assembly 1200 and may be positioned over the collar 1220 and may be the same as the Figure 10 collar cap 1000. The outer housing may include an inner surface 1211 and an outer surface 1213. As Figure 11A shown, the collar cap 1222 may be threadedly connected to the graft quick-connect assembly 1208 and the threaded connection 1225.

[0078] The pump assembly 1201 may include a pump outlet that may direct blood out of the pump and toward the graft tube 1204. The pump outlet may be cylindrical in shape or may be metallic (e.g., titanium, stainless steel, alloy, etc.). It should be understood that the pump outlet may be any type of biocompatible material. The pump outlet 1230 may include a recessed portion 1232 that may extend circumferentially around one end of the pump outlet 1230. A connector assembly 1234 may be connected to the pump outlet 1230. The connector assembly may include an inner assembly 1236 that may be cylindrical in shape (e.g., a cylindrical protrusion) and may include a protrusion that may be received by the recessed portion 1232 and may secure the inner assembly 1236 to the pump outlet 1230. Alternatively or additionally, the inner assembly 1236 may be welded, adhered, or otherwise connected to the pump outlet 1230. The inner assembly 1236 (e.g., including the cylindrical protrusion) may be received by a pump receiving area between an inner surface 1213 and an outer surface 1209.

[0079] The inner assembly 1236 may include an inner diameter and an outer diameter sized to extend into and be received by the receiving channel 1218. The inner assembly 1236 may further include a recessed portion 1237 that may be a circumferential recessed area for receiving a portion of the seal ring 1238. The seal ring 1238 and the receiving channel 1218 may form a liquid-tight seal with the outer surface 1213 to form a liquid-tight seal between the graft quick connect assembly 1200 and the pump assembly 1201. The seal ring 1238 may be any well-known seal ring or O-ring.

[0080] The outer assembly 1240 can be positioned around the outlet and can form one or more tabs. For example, the outer assembly 1240 can be of a cylindrical shape and / or can have a slit in the cylindrical shape to facilitate the formation of the outer assembly 1240. A space can be defined between the inner diameter of the outer assembly 1240 and the outer diameter of the outlet 1230. The outer assembly 1240 can be connected to the inner assembly 1236 only at the left side of the outer assembly 1240. For example, the outer assembly 1240 can be metallic and can be welded to the inner assembly 1236 at its left side. The right side of the outer assembly 1240 can be independent and can be compressed to reduce the diameter of the right side of the outer assembly 1240. The outer assembly 1240 can include tabs 1246 for compressing the right side of the outer assembly 1240. The outer assembly 1240 can further include a circular protrusion 1248, which can be connected to and / or extend from the tab 1246, and when the tab 1248 is compressed, can be moved inwardly toward the outlet 1230. As the tab 1246 transitions from an expanded position to a contracted position (e.g., via pinching), the circular protrusions 1248 can be moved closer to each other. The circular protrusions 1248 can be angled such that the left side has a diameter smaller than the right side. For example, the left side can have a height lower than the height of the right side. It should be understood that the circular protrusion 1248 can have a circular profile, or can be a protrusion of any other shape or design other than circular or cylindrical.

[0081] Now referring to Figure 11B , the graft connection assembly 1200 and the pump assembly 1201 can be mated such that blood can flow therebetween. For example, the inner assembly 1236 including the seal ring 1239 can be inserted into and received by a receiving channel 1218 defined by the receiving flange 1212 and the outer flange 1216 together. Other angled circular protrusions can be positioned into corresponding through-holes of the connector flange 1210. The flange 1210 can include circumferentially arranged through-holes. The circular protrusions can be sized to fit within the through-holes of the flange 1210 and extend through the through-holes of the flange 1210 to lock, connect, or otherwise secure the graft quick connection assembly 1200 to the pump assembly 1201. The outer assembly 1240 can transition from an expanded position to a contracted position to unlock or otherwise disconnect the graft quick connection assembly 1200 and the pump assembly 1201.

[0082] It may be desirable to release the circular protrusion 1248 from the connector flange 1210 to rotate the graft tube 1204 relative to the pump assembly 1201. However, as blood may flow through the graft connection assembly 1200, it is not desirable to disconnect the graft connection assembly 1200 from the pump assembly 1201. Instead, the graft connection assembly 1200 can be rotated relative to the pump assembly 1201 by compressing the tab 1246 to move the circular protrusion out of the corresponding through-hole of the connector flange 1210, without the need to disconnect the graft connection assembly 1200 from the pump assembly 1201. When the tab 1246 is compressed, the graft connection assembly can be rotated relative to the pump assembly 1201 while the seal ring 1239 maintains the seal between the receiving flange 1212 and the inner assembly 1236. Once the desired position of the graft connection assembly 1200 is reached, the tab 1246 can be released, and the circular protrusion can engage the corresponding through-hole of the connector flange 1210 to lock the graft connection assembly 1200 to the pump assembly 1201 to prevent any axial or rotational movement between the graft connection assembly 1200 and the pump assembly 1201.

[0083] Now referring to Figures 11C to 11D , a perspective view of the graft connection assembly 1200 and the pump assembly 1201 is depicted. As shown in Figure 11C , the connector flange 1210 can extend circumferentially and include a plurality of through-holes. Additionally, the seal ring 1239 can be positioned near the leftmost region of the inner assembly 1236. The circular protrusion 1236 can be an angled circular protrusion. In one example, another tab 1246 can be square-shaped. It should be understood that the outer assembly 1240 can include a reduced portion 1241, which can be a section of the outer assembly 1240 having a reduced length compared to the wing portion 1243 of the outer assembly 1240 having the tab 1246. It should be understood that the wing portion 1243 can have greater flexibility and / or be deformable by a greater amount compared to the reduced portion 1241.

[0084] Now referring to Figures 12A to 12B, a punching tool can be used to cut a hole in a patient's heart suitable for pump installation. For example, the punching tool 1280 can be sized to fit and attached to the apex assembly 1270. It should be understood that the apex assembly 1270 can be any apex assembly described herein (e.g., the apex assembly 1270). The punching tool can include a cutting portion 1296 for making a circular cut in the heart tissue (e.g., at the apex of the heart). The cutting portion 1296 can form a hole having a diameter sized to receive the inlet of the pump. In one example, the cutting portion 1296 can cut a hole approximately 90% of the diameter of the pump inlet. This slight reduction in the size of the ventriculotomy compared to the pump inlet diameter ensures that the heart tissue exerts a compressive force on the pump inlet to help prevent blood leakage from the heart chamber between the interface of the pump inlet and the heart tissue. The outer portion of the cutting anvil wall includes at least a transparent part to allow visualization of the core of the tissue that has been cut and captured by the cutting device before removing the punching tool from its position within the apex assembly 1270. Incomplete punching where a complete circular core of tissue that includes the full depth of the heart wall is not obtained can result in pump inlet misalignment, thrombus formation within the heart chamber, and other adverse effects. When the pump is implanted without using extracorporeal circulation, removing the punching tool from the apex assembly 1270 results in significant bleeding. Inspecting the cut tissue with the punching tool held in place using a suture ring allows confirmation of a proper punching procedure or allows re-punching of the tissue (i.e., repeating the ventriculotomy) to achieve a complete, circular, full-heart-wall-depth incision to assist in the optimal positioning of the pump relative to the patient's heart.

[0085] The surgeon can make a cruciform incision in the heart wall through the center of the suture ring and then insert the punching tool 1270 into the incision until the extended diameter portion of the anvil engages the suture ring. It should be understood that the cutting portion can be attached to a spring 1298 (e.g., to bias the cutting portion to a closed position). The punching tool 1280 can further include a handle 1292 to facilitate user control and grasping and can also include a knob 1294 that can be connected to the cutting portion 1296 and / or can be mechanically connected to the spring 1298. The user can squeeze the handle 1292 towards the knob 1294, compressing the spring 1298 and extending the cutting device into the heart chamber. The tip of the cutting device can be rounded to prevent damage to the internal structures of the heart chamber, especially the chordae tendineae. The cutting edge of the blade can similarly be oriented towards the endocardial surface of the heart wall to prevent accidental incision of the internal heart structures. After the cutting device is fully inserted, as the cutting device retracts through the spring 1298, the user can release the compressive force on the spring 1298 and rotate the knob 1294 to rotate the cutting portion 1296 to completely cut the tissue captured by the cutting device. For example, it may be necessary to rotate or actuate the cutting blade to completely cut through a 0.5 to 1.5 cm thick heart wall.

[0086] Reference Figures 13A to 13C , referring to the apex assembly 1300, which may include a suture ring 1302 that may be the same as or similar to the suture ring 204 of Figure 2A . The suture ring 1302 may be connected to a ring support 1306, which may be an upper support or may be connected to a connector housing 1304, which may be a lower support. The ring support 1306 may include an inner surface 1309 and a lower surface located below and orthogonal to the inner surface 1309. The connector housing 1304 may include an inner surface 1307 and an upper surface located above and orthogonal to the inner surface 1307. The inner surface 1307 may include a recessed area in which a seal ring 1317 may be positioned to form a liquid-tight seal with a portion of the heart pump extending into the channel or central aperture formed by the inner surface 1309 and the inner surface 1307. The connector housing may further include a recess similar to Figure 2A the recess 240 of Figure 2A . The connector housing 1304 and the ring support 1306 may be similar to the connector housing 210 and the ring support 212 of

[0087] Now referring to Figure 13C , the tightening assembly 1310 (which may be a locking assembly) may include posts 1311, each of which includes a tapered base within the ring support 1306 and extends therefrom, allowing a lock 1312 to slide inwardly and outwardly under the guidance of each tapered base that may form a channel, and the lock 1312 may move along the channel towards the inner surface of the connector housing 1304. The lock may be restricted by each tapered base, the upper surface of the connector housing, and the lower surface of the ring support 1306 from moving in all other directions. The lock 1312 may be guided inwardly by a tightening ring 1314, and the tightening ring 1314 may be tightened or loosened by a tab 1313 that may move between an open position and a closed position. In the closed position, the tab 1313 (which may be a handle) may tighten the ring 1311 to move the lock 1312 inwardly and tighten the pump inlet to fix the apex assembly 1300 to the pump inlet by friction.

[0088] The tab 1313 can be connected to one end of the tightening ring and can include a slider extending through a portion of the tab 1313. The arm 1319 can be connected to the second end of the tightening ring 1314 at one end of the arm 1319 and can be slidably connected to the slot of the tab 1313 at the second end of the arm 1319. In this way, the tab 1313 can be used to move the ends of the tightening ring 1314 farther apart or closer together. As the tightening ring moves to the closed position, where the two ends of the tightening ring are close to each other, the lock 1312 can be moved in the channel toward the inner surface of the connector housing 1304 and ultimately extend partially beyond the inner surface. In the closed position, the tightening ring 1314 can cause the lock 1312 to contact the cannula or other structure of the heart pump to fix the apex assembly 1300 to the heart pump.

[0089] Now refer Figure 14A to D to illustrate an exemplary implantable heart pump system. As Figure 14A shown in D, the implantable heart pump system 1400 can include a heart pump 1402, an apex connector 1403, a suture ring 1404, a pump quick connector 1406, a graft connection assembly 1408, and a graft quick connector 1418. The heart pump system 1400 can be the same as or similar to Figure 1 the heart pump system 100. The heart pump 1402, the apex connector 1403, the suture ring 1404, the pump quick connector 1406, the graft connection assembly 1408, and the graft quick connector 1418 can be the same as or similar to Figure 1 the heart pump 102, the apex connector 103, the suture ring 104, the pump quick connector 106, the graft connection assembly 108, and the graft quick connector 118.

[0090] For purposes of illustration and description, the foregoing description of the illustrative embodiments has been presented. Of course, it should be understood that the embodiments described herein are illustrative, and that components can be arranged, substituted, combined, and designed in a variety of different configurations, all of which are contemplated and fall within the scope of the present disclosure. It is not intended to be exhaustive or limiting with respect to the precise forms disclosed, and modifications and variations are possible in light of the above teachings, or may be acquired from the practice of the disclosed embodiments. The scope of the invention is intended to be defined by the appended claims and their equivalents.

Claims

1. An assembly for connecting a graft tube to a blood pump, the assembly comprising: A graft assembly configured to be coupled to one end of the graft tube, the graft assembly forming a cylindrical structure, the cylindrical structure comprising: An inner housing having a first outer surface and a second outer surface; An outer housing offset from the inner housing and defining a graft receiving region between a first inner surface of the outer housing and the first outer surface of the inner housing, and defining a pump receiving region between a second inner surface of the outer housing and the second outer surface of the inner housing; A flange extending from the cylindrical structure and having a plurality of through-holes arranged circumferentially; A pump assembly configured to be coupled to a cannula of the blood pump, the pump assembly comprising: A cylindrical protrusion sized and configured to be received in the pump receiving region; and A set of protrusions extending from the cylindrical protrusion and configured to be received by and extend through a set of the plurality of through-holes of the flange.

2. The assembly according to claim 1, wherein the cannula is an outlet of the blood pump, and wherein the cylindrical protrusion is configured to be rotatably coupled to the outlet of the blood pump such that when the cylindrical protrusion is coupled to the outlet of the blood pump, the pump assembly is free to rotate relative to the outlet of the blood pump.

3. The assembly according to claim 1, wherein the cylindrical protrusion includes a sealing ring configured to form a liquid-tight seal between the graft assembly and the pump assembly.

4. The assembly according to claim 3, wherein the pump assembly is configured to rotate relative to the graft assembly when the cylindrical protrusion is received in the pump receiving region and the sealing ring maintains a liquid-tight seal.

5. The assembly according to claim 1, wherein the pump assembly further includes a set of tabs extending from the set of protrusions, the set of tabs configured to be depressed to transition the set of protrusions between an expanded position and a contracted position.

6. The assembly according to claim 5, wherein the set of protrusions is configured to move closer together when the set of tabs is in the contracted position and is configured to move further apart when the set of tabs is in the expanded position.

7. The assembly according to claim 1, wherein the set of protrusions is configured to lock the pump assembly to the graft assembly when the set of protrusions extends through the set of through-holes of the flange.

8. The assembly according to claim 1, wherein each protrusion of the set of protrusions has a first end with a first height and a second end with a second height greater than the first height.

9. The assembly according to claim 1, wherein each protrusion of the set of protrusions has a circular profile.

10. The assembly according to claim 1, wherein the graft receiving region is configured to receive and couple to the one end of the graft tube to fix the graft assembly to the graft tube.

11. A method for connecting a graft tube to a heart pump via an assembly including a graft assembly and a pump assembly, the method comprising: positioning the graft assembly adjacent to the pump assembly, the graft assembly being configured to couple to one end of a graft tube and including a cylindrical structure and a flange extending from the cylindrical structure and having a plurality of through holes, the pump assembly including a cylindrical protrusion configured to couple to a cannula of the heart pump; transitioning a set of tabs on the pump assembly to a compressed state, each of the set of tabs having a protrusion and each extending from the cylindrical protrusion of the pump assembly; aligning the protrusion of each of the tabs with the through holes of the flange of the graft assembly when the tabs are in the compressed state; extending the protrusion of each of the tabs through a respective one of the plurality of through holes of the flange by transitioning the set of tabs to an expanded state when the protrusion of each of the tabs is aligned with the through holes of the flange, wherein when the protrusion of each of the tabs extends through the respective through hole, the cylindrical protrusion engages the cylindrical structure and is in fluid communication therewith.

12. The method according to claim 11, wherein the cylindrical structure of the graft assembly includes an inner housing and an outer housing, and a pump receiving region is defined between the inner housing and the outer housing.

13. The method according to claim 12, wherein a portion of the cylindrical protrusion is received by the pump receiving region when the protrusion of each of the tabs extends through the respective through hole of the flange.

14. The method according to claim 12, wherein the cylindrical structure of the graft assembly and the cylindrical protrusion of the pump assembly form a liquid-tight seal between the graft tube and the cannula when the protrusion of each of the tabs extends through the respective through hole of the flange.

15. The method according to claim 12, wherein the cylindrical protrusion has a sealing ring, and when the cylindrical protrusion is received by the pump receiving region, the sealing ring engages both the cylindrical protrusion and the cylindrical structure.

16. The method according to claim 12, wherein the graft receiving region is defined between the inner housing and the outer housing, and the graft receiving region is configured to receive the one end of the graft tube.

17. The method according to claim 11, wherein the plurality of through holes of the flange are circumferentially arranged.

18. The method according to claim 11, wherein the cylindrical protrusion and the sleeve are coaxial along a first axis, and when the cylindrical protrusion is coupled to the sleeve, the cylindrical protrusion is allowed to rotate relative to the sleeve along the first axis.

19. The method according to claim 11, wherein each of the plurality of through-holes is of a circular shape, and the protrusion of each of the tabs has a circular profile.

20. The method according to claim 11, wherein when the set of tabs is in the compressed state, the protrusions of each of the tabs are positioned closer to each other compared to when each of the tabs is in the expanded state.

21. An apex connector for attaching a heart pump to the apex of a patient's heart, the apex connector comprising: a housing including a first end having a first diameter and a second end having a second diameter smaller than the first diameter, the first end being configured to receive a portion of the heart pump, and the second end being configured to engage a sleeve of the pump extending beyond the portion of the pump; a spring having an expandable portion configured to be disposed within the housing and a handle portion configured to extend through an aperture of the housing, the spring being configured to transition from an expanded position to a contracted position about the protrusion of the heart pump; and a suture ring coupled to the housing at the second end, the suture ring being configured to conform to the patient's heart and couple the apex connector to the patient's heart.

22. The apex connector according to claim 21, wherein the housing includes a connector housing having the first end and a ring support having the second end, the connector housing being coupled to the ring support.

23. The apex connector according to claim 21, wherein the connector housing includes a plurality of pits configured to facilitate engagement with a support tool.

24. The apex connector according to claim 21, wherein the spring is configured to be disposed within the connector housing, and the suture ring is configured to be coupled to the ring support.

25. The apex connector according to claim 21, further comprising a flange coupled to the housing at the second end and configured to be coupled to the suture ring.

26. The apex connector according to claim 25, wherein the flange includes a plurality of through-holes and is angled away from the first end.

27. The apex connector according to claim 26, wherein the suture ring includes a silicone layer configured to surround at least a portion of the flange and enter the through-holes.

28. The apex connector according to claim 21, wherein the suture ring includes at least one layer of biocompatible felt and at least one layer of silicone resin.

29. The apical connector according to claim 28, wherein the suture ring comprises a first layer of biocompatible felt, a second layer of silicone, and a third layer of biocompatible felt, and the second layer of silicone is positioned between the first layer of biocompatible felt and the second layer of biocompatible felt.

30. The apical connector according to claim 31, wherein the spring is configured to fix the housing to the heart pump when the spring is in the contracted position.

31. An apical connector for fixing a heart pump to the apex of a patient's heart, the apical connector comprising: an upper support having a first inner surface and a lower surface; a lower support having a second inner surface and an upper surface configured to engage the lower surface of the upper support, the upper surface defining a plurality of channels; a plurality of locks, each configured to move in a respective one of the plurality of channels in a first direction toward the second inner surface and selectively extend beyond the second inner surface, the plurality of locks being restricted by the upper support and the lower support from moving in a direction other than the first direction; a lock assembly comprising a ring and a handle, the handle being configured to transition the ring from an open position to a closed position, wherein the closed position of the ring causes the plurality of locks to move in the first direction to partially extend beyond the second inner surface.

32. The apical connector according to claim 31, further comprising a suture ring coupled to the upper support, the suture ring being configured to conform to the patient's heart and couple the apical connector to the patient's heart.

33. The apical connector according to claim 32, wherein the suture ring is configured to be coupled to the patient's heart via one or more sutures.

34. The apical connector according to claim 32, wherein the suture ring comprises silicone inserted between layers of biocompatible felt.

35. The apical connector according to claim 31, wherein the ring is configured to push the plurality of locks through the respective channels of the plurality of channels so that each of the locks partially extends beyond the second inner surface.

36. The apical connector according to claim 35, wherein each of the locks of the plurality of locks is configured to engage a part of the heart pump when the lock assembly transitions to the closed position to couple the apical connector to the heart pump.

37. The apical connector according to claim 31, wherein the ring comprises a first end and a second end, and the handle is configured to rotate about the first end to change the distance between the first end and the second end of the ring.

38. The apical connector according to claim 37, wherein the handle comprises a slot, and the lock assembly further comprises an arm that is connected to the second end of the ring at a main end and is configured to engage the slot of the handle at a secondary end.

39. The apical connector according to claim 31, wherein the second inner surface includes a seal ring recessed area, and the apical connector further includes a seal ring partially disposed within the seal ring recessed area.

40. The apical connector according to claim 31, wherein the cylindrical housing has a plurality of pits configured to facilitate engagement with a support tool.

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