Internal Devices

Abstract

The present invention relates to intracorporeal devices and methods, wherein at least one anatomical wall is an endocardial wall and at least one anatomical wall is an ectocardial wall. The present invention relates to an intracorporeal device 1 for assisting cardiac function in a patient, the intracorporeal device 1 being adapted and configured to be secured across at least two anatomical walls of the heart 2, 3, 4. The present invention also relates to a method for assisting cardiac function in a patient, the method comprising securing the intracorporeal device 1 across at least two anatomical walls of the heart 2, 3, 4, at least one anatomical wall being an endocardial wall and at least one anatomical wall being an ectocardial wall.

Description

[Technical Field]

[0001] The present invention relates generally to the field of medical and surgical devices. More particularly, the present invention relates to catheters and corresponding methods of using catheters. The present invention is particularly useful in the context of minimally invasive transcatheter and / or percutaneous procedures, such as those described in PCT Application No. International Publication No. EP2015 / 055578, entitled "PERCUTANEOUS SYSTEM, DEVICES AND METHODS," filed March 17, 2015, and expressly incorporated by reference in its entirety. [Background technology]

[0002] In International Application EP 2015 / 055578, the inventors describe an intracorporeal connector for fluid communication between a first anatomical compartment and a second anatomical compartment, in particular a ventricular assist system for enabling blood flow between a patient's left atrium and aorta. The system is implanted across the roof of the left atrium and the aortic wall and typically comprises two main components: an anchor or connector element and a fluid regulating device such as a pump.

[0003] The ventricular assist system is preferably delivered and implanted using a transcatheter system, such as that described in PCT Application No. International Publication No. EP 2015 / 055578, or International Publication No. EP 2016 / 082889, filed December 29, 2016, entitled "TRANSCATHETER INSERTION SYSTEM," PCT Application No. International Publication No. EP 2017 / 050275, filed January 6, 2017, entitled "CONNECTOR AND METHOD FOR COUPLING ANATOMICAL WALLS," and U.S. Patent Application Nos. 15 / 288642 and 15 / 288738, filed October 7, 2016, all of which are incorporated herein by reference.

[0004] The connector element includes a proximal portion, an intermediate portion, and a distal portion. The proximal portion includes a plurality of arms that abut the wall of the first compartment in the operational configuration, the intermediate portion includes a fluid conduit and is positioned across the anatomical wall in the operational configuration, and the distal portion includes a plurality of arms that abut the aortic wall in the operational configuration. The intermediate portion is adapted and configured to maintain contact between the two anatomical walls, while the distal and proximal arms are adapted and configured to maintain the structural integrity of the anatomical walls. This is particularly important because the connector is adapted and configured to safely support the fluid regulating device across an anatomical wall that is under pressure and prone to slippage due to, for example, the structure of the fluid regulating device itself, the pump, and blood flow generated by patient movement.

[0005] While the above-described ventricular assist systems can be safely implanted and successfully establish fluid flow, the size and structure of the heart are such that the fluid regulation device, and consequently the delivery and implantation methods and systems, must be adapted. The fluid regulation device typically includes a pump element, a motor element, and optionally a battery element (e.g., as described in PCT Application No. EP2016 / 069159, filed August 11, 2016), and, if necessary, a means for charging the battery. Space and maneuvering within the heart are limited, and miniaturization can only be considered to the extent that the efficiency of the fluid regulation device is not adversely affected. As the device size increases, it exerts greater pressure on the anatomical walls, potentially compromising their integrity. Therefore, there is a risk of trauma to the cardiac tissue, which can be dangerous and potentially fatal to the patient.

[0006] The object of the present invention is to alleviate the above problems. Summary of the Invention

[0007] According to a first aspect, there is provided a method for assisting cardiac function in a patient, the method comprising the step of securing an intracorporeal device across at least two anatomical walls of the heart, at least one anatomical wall being an endocardial wall and at least one anatomical wall being an ectocardial wall.

[0008] Thus, the intracorporeal device is securely fixed to the heart using a two-point anchoring system. The device is stabilized and pressure exerted on cardiac structures by the device and blood flow is shared, thereby reducing stress and risk of trauma to any single wall.

[0009] In the context of the present invention, "internal" means inside a patient's body, and "extracorporeal" means outside a patient's body. For example, an intracorporeal device or component is located within a patient's body, and an extracorporeal device or component is located outside a patient's body.

[0010] In the context of the present invention, "endocardial" means the inside of the heart, and "extracardial" means between the inside and outside of the heart, or outside of the heart. For example, an endocardial wall is an anatomical wall located inside the heart. Examples of an endocardial wall include, but are not limited to, the interatrial septum between the right atrium and the left atrium and the interventricular septum between the right ventricle and the left ventricle. An extracardiac wall can be an anatomical wall between the inside and outside of the heart, for example, the anatomical wall between the inside of the left atrium, right atrium, left ventricle, or right ventricle and the outside of the heart and even the aortic wall.

[0011] In a preferred embodiment, the intracardiac wall is the atrial septum, and the extracardiac wall is the wall of the left atrium, most preferably the roof of the left atrium. These anatomical walls are particularly useful for implanting a fluid regulating device that regulates fluid flow from the left atrium to the aorta. For example, in International Application EP 2015 / 055578, a fluid regulating device is inserted through a perforation in the atrial septum and then implanted on the roof of the left atrium, allowing blood to flow from an inlet located in the left atrium to an outlet located in the aorta. The left atrial and aortic walls are subjected to tension due to the implantation of the fluid regulating device itself and pressure due to fluid flow. By providing a second anchoring point, for example on the atrial septum, the device is stabilized, and the anatomical walls individually experience less pressure. Therefore, the risk of injury, trauma, and leakage is minimized. The atrial septum is preferred because it is generally rigid and robust enough to secure and support an intracardiac device, yet flexible enough to cushion movement during and after implantation. In addition, the atrial septum is often used as an insertion route and can be used as a second anchor point without the need for additional perforation.

[0012] Preferably, the method further includes a step of fixing the intracorporeal device across at least a third anatomical wall. More preferably, the third anatomical wall is a wall adjacent to the outer wall of the heart. In the context of the present invention, "adjacent walls" means "walls that are naturally physically close." For example, the two adjacent walls may be adjacent walls of two adjacent anatomical compartments, such as the wall of the left atrium and the wall of the aorta. In a preferred embodiment, the third anatomical wall is the wall of the aorta adjacent to the roof of the left atrium.

[0013] The present invention is particularly useful for establishing fluid flow between two anatomical compartments separated by at least two anatomical walls. As described in International Application EP 2015 / 055578, the anatomical walls are pressed into contact with each other by a delivery catheter or outer sheath, pierced, and secured together, for example, using a connector. When two anchor points are provided, pressure and tension are distributed and not concentrated on and around the connector.

[0014] Preferably, the intracorporeal device comprises a proximal portion to be disposed in a first anatomical compartment, an intermediate portion to be disposed in a second anatomical compartment, and a distal portion to be disposed in a third anatomical compartment. In a preferred embodiment, the proximal portion of the intracorporeal device is to be disposed in the right atrium, the intermediate portion is to be disposed in the left atrium, and the distal portion is to be disposed in the aorta. Thus, the intracorporeal device can be fixed to the atrial septum (between the proximal and intermediate portions) and the walls of the left atrium and aorta (between the intermediate and distal portions).

[0015] The location of the various elements of the intracorporeal device may be adapted and configured to assist fluid flow between any two compartments, as described in more detail below. In a preferred embodiment, the intracorporeal device is a fluid regulating device for assisting fluid flow from a second compartment to a third compartment, for example, from the left atrium to the aorta.

[0016] Preferably, the intracorporeal device is secured to one or more anatomical walls by a connector, which may be a separate connector or may be integrally formed or attached to the intracorporeal device.

[0017] Preferably, the connector comprises a neck to be positioned across one or more anatomical walls, a first plurality of arms extending from a first end of the neck, and a second plurality of arms extending from a second end of the neck. As described in applicant's previous applications cited herein, the arms are preferably movable from a transcatheter delivery configuration (e.g., in line with the neck) to an operating configuration (e.g., generally perpendicular to the neck).

[0018] In the case of separate connectors, the connector and / or the intracorporeal device comprises means for coupling the intracorporeal device to the connector.

[0019] Preferably, the connector is integrally formed with or coupled to the intracorporeal device. In this embodiment, the connector comprises means for connecting the intracorporeal device to an anatomical wall. For example, the intracorporeal device can comprise multiple arms extending from the intracorporeal device. Preferably, the arms are movable from a transcatheter delivery configuration (e.g., in line with the neck) to an operating configuration (e.g., generally perpendicular to the neck).

[0020] In a preferred embodiment, the intracorporeal device comprises means for securing the intracorporeal device to the connector. Preferably, the securing means comprises a plurality of arms extending from the intracorporeal device, preferably from the distal end of the intracorporeal device. The arms can be moved from a delivery configuration (e.g., extending generally longitudinally from the intracorporeal device) to an operational configuration (e.g., extending away from the longitudinal axis of the intracorporeal device). In the operational configuration, the securing arms can cooperate with the connector to anchor the intracorporeal device to the anatomical wall. Additionally, the securing arms can provide additional support to the wall tissue for fluid flow and / or the weight and bulk of the intracorporeal device.

[0021] Preferably, the intracorporeal device includes one or more recesses adapted and configured to receive one or more anatomical walls. In a preferred embodiment, the intracorporeal device includes an elongated or substantially cylindrical housing. The intracorporeal device may include a circumferential recess adapted to receive the anatomical wall therein, thereby securing the intracorporeal device to the wall. Preferably, the recess has sloped or curved walls to facilitate insertion into the recess of the anatomical wall.

[0022] According to a second aspect of the present invention, there is provided an intracorporeal device for assisting cardiac function in a patient, the intracorporeal device being adapted and configured to be anchored across at least two anatomical walls of the heart.

[0023] Preferably, at least one anatomical wall is an endocardial wall and at least one anatomical wall is an epicardial wall.

[0024] Preferably, the intracorporeal device is adapted and configured to be secured to one or more anatomical walls by a connector, said connector being integrally formed with or coupled to the intracorporeal device.

[0025] Preferably, the intracorporeal device is adapted and configured to be secured to one or more anatomical walls by a connector and a securing means, said connector being configured to be positioned across one or more anatomical walls, and said securing means being integrally formed with or coupled to the intracorporeal device.

[0026] Preferably, the fixation means comprises a plurality of arms extending from the intracorporeal device, for example from the distal end of the intracorporeal device.

[0027] Preferably, the intracorporeal device comprises one or more recesses adapted and configured to receive one or more anatomical walls.

[0028] Preferably, the intracorporeal device comprises a proximal portion intended to be positioned in a first anatomical compartment, an intermediate portion intended to be positioned in a second anatomical compartment, and a distal portion intended to be positioned in a third anatomical compartment.

[0029] Preferably, the intracorporeal device comprises a motor located in the proximal portion. Preferably, the intracorporeal device comprises one or more fluid inlet ports in the intermediate portion. Preferably, the intracorporeal device comprises a pump in the intermediate portion.

[0030] Preferably, the pump comprises an impeller and a pump housing, the impeller being disposed within the pump housing. The impeller is a rotatable element, commonly referred to as an axial impeller, that accelerates fluid outward from a center of rotation in a direction parallel to the impeller's major (longitudinal) axis. The impeller rotates about its major axis relative to the pump housing. Because the impeller is enclosed in the pump housing, the rotational speed of the impeller is converted into pressure when the outward movement of the fluid is restricted by the pump housing.

[0031] Preferably, the impeller has a tapered shape. The tapered shape increases from the proximal end of the impeller toward the center, then decreases toward the distal portion so that the cross section of the tapered impeller approaches an ellipse, with the major axis of the ellipse parallel to the major axis of the pump housing. The tapered shape of the impeller has the advantage of increasing fluid pressure within the pump housing. Therefore, fluid, such as blood, spends less time around heat-generating device components, such as the motor and various bearings within the intracorporeal device. This reduces the likelihood of fluid damage from heat generated by the device, which in turn reduces the likelihood of fluid coagulating and blocking the circulatory system. Therefore, the fluid cools the surfaces of the motor housing and internal pump elements.

[0032] Preferably, the intracorporeal device includes one or more fluid outlet ports in the distal portion. Depending on the compartment through which fluid enters or exits, one or more fluid inlet ports may be located in the proximal portion and / or the intermediate portion. In a preferred embodiment, the proximal portion of the intracorporeal device is intended to be located in the right atrium, the intermediate portion is intended to be located in the left atrium, and the distal portion is intended to be located in the aorta. In a most preferred embodiment, the intermediate portion includes one or more inlet ports and the distal portion includes one or more outlet ports, allowing fluid to flow from the left atrium to the aorta.

[0033] Preferably, the lengths of the intermediate and distal portions are designed so that one or more fluid inlet ports in the intermediate portion are positioned within the left atrium and one or more fluid outlet ports in the distal portion are positioned within the aorta.

[0034] Preferably, the intracorporeal device includes a static diffuser disposed within the distal portion of the intracorporeal device. Preferably, the diffuser is disposed between the impeller and one or more fluid outlet ports. Preferably, the diffuser is coupled to the end of the impeller via a bearing. Preferably, the diffuser is fixedly mounted within the pump housing so that the diffuser cannot rotate. Preferably, the diffuser and bearing support the impeller, allowing the impeller to rotate about its main axis, but the diffuser remains fixed within the pump housing. Advantageously, the diffuser increases fluid diffusion from the outlet of the device due to the angle and shape of the diffuser blades.

[0035] Preferably, the intracorporeal device comprises anchoring means arranged to anchor the intracorporeal device to the anatomical wall. Preferably, the anchoring means is at the end of the distal portion of the intracorporeal device.

[0036] Preferably, during use, the connector is positioned through the roof of the left atrium and the aortic wall. Preferably, the neck of the connector and / or the distal portion of the intracorporeal device forms a pericardial seal. Preferably, the neck of the connector acts as a docking means to assist in coupling the distal portion of the intracorporeal device across the anatomical wall and to the connector.

[0037] The fixation means may be, for example, a type of anchor / support member with several arms / tissue support members that can be deployed against the wall of the aorta to position and secure the distal portion of the device relative to the aorta and allow efficient fluid transfer through the device.

[0038] Preferably, the intracorporeal device comprises a static diffuser located at the end of the distal portion. This has the advantage of further increasing fluid diffusion at the outlet of the device, as the fixed blades assist in fluid diffusion. This also has the advantage of facilitating easier deployment of the device, as a guidewire and / or balloon can be attached to a guidewire holder on the static diffuser to allow for accurate placement within the human body.

[0039] Preferably, the intracorporeal device includes a motor coupling element arranged to couple the drive shaft of the motor to the pump. Preferably, the motor coupling element is arranged between the motor and the impeller. Preferably, the motor coupling element magnetically couples the drive shaft of the motor to the pump. This has the advantage that the motor and drive shaft can be easily removed from the rest of the intracorporeal device while maintaining a seal of the motor and drive shaft against fluid in the circulatory system. Thus, the component of the intracorporeal device that is most likely to require removal, modification, or replacement, such as the motor, can be easily removed and replaced while the rest of the intracorporeal device remains in place within the body.

[0040] Preferably, the motor coupling element axially couples the drive shaft of the motor to the pump, which has the advantage of simplifying the coupling between the drive shaft of the motor and the pump while maintaining a seal between the motor and the body fluid.

[0041] Preferably, the motor coupling element radially couples the motor drive shaft to the pump. Preferably, a portion of the motor coupling element surrounds and magnetically couples the elongated portion of the motor that houses the motor drive shaft. This has the advantage of increasing torque transmission between the drive shaft and the pump impeller. The radial configuration of the coupling magnetic force eliminates additional bearing loads and heat due to friction.

[0042] Preferably, the motor, drive shaft, and magnetic element at the end of the drive shaft are located within a sealed housing. This has the advantage that the motor can be placed within the circulatory system. If the elements discussed above were not located within a sealed housing, the fluid in the circulatory system could damage these elements and / or the elements could cause contamination of the fluid in the circulatory system.

[0043] Preferably, the portion of the motor coupling element partially surrounds the portion of the sealed housing that houses the magnetic elements, which has the advantage of promoting radial magnetic coupling and allowing fluid to flow between the motor coupling element and that portion of the sealed housing.

[0044] Preferably, there is a clearance space / gap between that portion of the motor coupling element and that portion of the sealed housing, which has the advantage of promoting fluid flow within the clearance space to prevent fluid damage.

[0045] Preferably, the interface of the motor coupling element is magnetically securable to the interface of the motor for coupling the motor drive shaft to the pump, and a fluid inlet is defined between said interfaces during coupling, which has the advantage of facilitating fluid flow between the interfaces so that fluid can enter gap spaces between the interfaces.

[0046] Preferably, a further interface of the motor coupling element couples with an interface of the impeller, which has the advantage of transferring the movement of the motor drive shaft to the impeller.

[0047] Preferably, the motor coupling element comprises one or more bore portions, which has the advantage of allowing fluid that has entered the clearance space to exit the motor coupling element, thereby cleaning the bearings inside the motor coupling element and not raising the temperature of the fluid to a point where it would be damaged.

[0048] Preferably, the one or more bore portions are boreholes and / or split arms that couple an interface of the motor coupling element to a respective impeller interface.

[0049] Preferably, in use, fluid flows between the motor interface and the motor coupling element interface and through one or more bore portions towards the impeller, which has the advantage of reducing heat in the bearings and preventing excessive heat from damaging the fluid.

[0050] Preferably, the one or more fluid inlet ports are disposed between the one or more bore portions and the impeller within the intermediate portion of the pump housing. This has the advantage of allowing fluid exiting the bore portions to mix with fluid entering the fluid inlet ports. Thus, excess heat absorbed by the fluid exiting the bore portions can be efficiently dissipated by the fluid entering through the fluid inlet ports.

[0051] Preferably, the intracorporeal device comprises a power source and control means. Preferably, the control means is coupled to the motor via a tapered portion. The tapered portion has the advantage of reducing strain on connectors between the motor and the power source and control means. Preferably, the tapered portion tapers down in dimension away from the proximal portion of the intracorporeal device.

[0052] Within the context of the present invention, the terms "proximal" and "distal" are used relative to the medical professional, e.g., the proximal end is the end closest to the medical professional and the distal end is the portion of the device that is first inserted into the patient.

[0053] Within the context of the present invention, transcatheter includes percutaneous, transatrial, transfemoral (through the leg), transapical (in the chest between the ribs), and transaortic (in the upper chest). Preferred embodiments are percutaneous systems, devices, and methods.

[0054] The invention will be further explained with reference to the drawings and figures. [Brief explanation of the drawings]

[0055] [Figure 1] FIG. 1 illustrates a method according to the present invention using a first intracorporeal device. [Figure 1A] FIG. 10 is another diagram illustrating a method according to the present invention of using the first intracorporeal device. [Figure 1B] FIG. 10 is another diagram illustrating a method according to the present invention of using the first intracorporeal device. [Figure 2] FIG. 10 illustrates a method according to the present invention using a second intracorporeal device. [Figure 3] 1 is a schematic diagram of an intracorporeal device incorporating fixation and control means according to the present invention; [Figure 4] FIG. 4 is a schematic view of the intracorporeal device from FIG. 3 without fixation means. [Figure 5A] 1 is a schematic diagram of the external appearance of an intracorporeal device without fixation or control means. [Figure 5B] 1 is a schematic diagram of the interior of an intracorporeal device without fixation or control means. [Figure 5C] FIG. 5C is a schematic diagram of a static diffuser utilized within the intracorporeal device of FIGS. 5A and 5B. [Figure 5D] FIG. 10 is a schematic diagram of an alternative impeller. [Figure 6A] 1 is a schematic cross-sectional view of an intracorporeal device utilizing radial coupling between a motor and a motor coupling element. [Figure 6B] 1 is a schematic cross-sectional view of an intracorporeal device utilizing an axial coupling between a motor and a motor coupling element. [Figure 7] FIG. 10 is a schematic diagram of a split arm from a motor coupling element. [Figure 8] 1 is an exploded schematic view of the components of the intracorporeal device. DETAILED DESCRIPTION OF THE INVENTION

[0056] The present invention has been described by way of examples and is provided for illustrative purposes only. These examples should not be construed as intended to limit the scope of protection defined in the claims. For example, while various embodiments have been described with respect to the heart and circulatory system, this is not intended to be limiting and is done so merely to provide examples of implementation. The embodiments disclosed herein may be utilized in any medical device implantable within the human body, e.g., the cardiovascular system, respiratory system, gastric system, nervous system, etc.; some examples include implantable pumps and drug delivery pumps. As used herein, the term "means" may be equivalently expressed as or substituted with the following terms: device, apparatus, structure, part, subpart, assembly, subassembly, machine, mechanism, article, medium, material, equipment, facility, system, body, or similar expressions.

[0057] Referring to FIG. 1, a method according to the present invention for supporting cardiac function in a patient is shown, comprising the step of fixing an intracorporeal device 1 across at least two anatomical walls of the heart, at least one anatomical wall being an endocardial wall and at least one anatomical wall being an ectocardial wall.

[0058] In this example, intracorporeal device 1 is secured across the interatrial septum 2 (an intracardiac anatomical wall), the roof of the left atrium 3 (an extracardiac anatomical wall), and the aortic wall 4 (i.e., a third anatomical wall). Intracorporeal device 1 comprises a proximal portion 5 that is disposed during use within the right atrium RA, an intermediate portion 6 that is disposed during use within the left atrium LA, and a distal portion 7 that is disposed during use within the aorta. A power and control cable 16 is coupled to an end of proximal portion 5.

[0059] The intracorporeal device 1 is generally cylindrical or comprises a generally cylindrical housing. A motor M is disposed within the proximal portion 5, and a pump P is disposed within the intermediate portion 6. The positions of the fluid inlet and outlet ports can be adjusted so that the fluid inlet port is formed within the first fluid supply compartment and the fluid outlet port is formed within the second fluid receiving compartment. In this example, the fluid inlet port 8 is formed within the intermediate portion 6, which is disposed within the left atrium LA, and the fluid outlet port 9 is formed within the distal portion 7, which is disposed within the aorta AO.

[0060] In an alternative embodiment, the motor M may be housed within the intermediate section 6. As a result, the proximal section 5 is no longer needed and is no longer located within the right atrium. Thus, only the power and control cables reside in the right atrium.

[0061] In Figure 1, intracorporeal device 1 includes a circumferential recess 10 between its proximal portion 5 and intermediate portion 6. The shape and dimensions of the recess are such that the atrial septum can be received within recess 10. Recess 10 can have sloped or curved walls, as shown in Figures 1A and 1B, respectively, to facilitate insertion of the atrial septum 2 into recess 10.

[0062] If the intracorporeal device 1 is to be secured to a single anatomical wall (e.g., the atrial septum 2), the recess 10 may be sufficient. However, if the intracorporeal device 1 is to be secured across two or more anatomical walls (e.g., the wall of the left atrium and the aortic wall 4), the connector 11 may be preferred. The connector 11 shown in FIG. 1 is a separate connector.

[0063] Connectors suitable for use in the context of the present invention are described in detail in International Application No. EP 2017 / 050275, U.S. Patent Application No. 15 / 288642, and U.S. Patent Application No. 15 / 288738. The connector 11 typically includes a neck 13 for fluid passage between two anatomical compartments, positioned across / through anatomical walls 3 and 4 during use, a first plurality of arms and / or blades 15 extending from the distal end of the neck 13 and resting against the wall of the receiving compartment during use, and a second plurality of arms and / or blades 14 extending from the proximal end of the neck 13 and resting against the wall of the supply compartment during use. The arms and / or blades are preferably integrally formed with or fixed to the distal end of the neck 13. During use, the arms and / or blades rest partially or entirely against the anatomical walls 3 and 4. The neck 13 also supports the intracorporeal device 1 when positioned across the anatomical walls 3 and 4. During use, (a portion of) the distal portion 7 on the intracorporeal device 1 is positioned through the neck 13 of the connector 11 and thus across the anatomical walls 3, 4. For example, the intracorporeal device may include a recess for receiving the neck of the connector. The dimensions of the neck 13 and the distal portion 7 of the intracorporeal device 1 are configured to form a pericardial cavity seal by coupling the distal portion 7 to the neck 13. Thus, the neck 13 facilitates sealing as well as docking the pump and supporting the intracorporeal device 1.

[0064] When the intracorporeal device is removed from the connector 11, the connector 11 forms a seal between the anatomical walls 3, 4 to prevent fluid diffusion between the two regions defined by said walls 3, 4.

[0065] This particular configuration secures the connector 11 to the anatomical walls 3, 4, allowing the connector 11 to maintain the anatomical walls 3, 4 in contact with one another while supporting the integrity of the anatomical walls 3, 4. Thus, the arms and / or blades act as tissue support members to support the integrity of the anatomical walls 3, 4.

[0066] The intracorporeal device 1 may be provided with one or more recesses, for example circumferential recesses, for receiving the neck 13 of the connector 11 therein.

[0067] Other means for securing the intracorporeal device 1 to the anatomical walls 2, 3, 4 are envisioned, including, but not limited to, tabs, hooks, arms, cushions, high friction surfaces, biologically active covers, and the like.

[0068] Referring to FIG. 2, an alternative method of securing the intracorporeal device 1 to the connector 11 is shown. Previously, referring to FIG. 1, the distal portion 7 of the intracorporeal device was coupled through / to the neck 13 of the connector 11, for example, by friction or by compression of the connector 11 (i.e., the connector 11 is preferably made from an expandable / compressible material). Alternatively, or in combination, several tissue support / securing members 12 may be coupled to the distal portion 7 of the intracorporeal device 1. When deployed, these tissue support / docking members 12 contact the aortic wall and further support the intracorporeal device 1 to the connector 11. Thus, the combination of the connector 11 and the tissue support / docking members 12 allows for enhanced support and the ability to easily couple and uncouple the distal portion 7 of the intracorporeal device 1 to the connector 11.

[0069] Referring to FIG. 3, a schematic diagram of an intracorporeal device 300 with associated fixation means 302 and control means 304 is shown. The fixation means 302 in this embodiment relates to the tissue support / docking member 12 described in connection with FIG. 2. The fixation means 302 comprises a coupler 330 attached to the proximal end of the fixation means 302. A number of pump docking members / support arms 306 are attached to the distal (opposite) end of the fixation means 302. FIG. 3 shows the fixation means 302 in a "deployed" position, with the number of pump docking members / support arms 306 extended generally perpendicular to the longitudinal axis of the intracorporeal device 300. During use, the pump docking members / support arms 306 abut a portion of the anatomical wall 4 (see FIGS. 1 and 2), e.g., the aortic wall, to position and secure the intracorporeal device 300 between the anatomical wall 3, 4 (see FIGS. 1 and 2) and the interior of the neck 13 of the connector 11.

[0070] The several pump docking members / support arms 306 act as tissue shields and pump protectors as the aortic wall is held away from the intracorporeal device 300 positioned inside the aorta. The several pump docking members / support arms 306 distribute pressure so that each individual docking member / arm does not damage the anatomical wall 4.

[0071] When the intracellular device 300 needs to be removed from over the anatomical walls 3, 4, the pump docking member / support arm 306 is repositioned to the "delivery" position, with the pump docking member / support arm 306 positioned generally parallel to the longitudinal axis of the intracellular device 300, allowing the device to be removed from the neck of the connector 11 (see FIG. 2). This has the advantage of allowing the intracellular device 300 to be removed without damaging the anatomical walls 3, 4 that are protected by the connector 11. Once the intracellular device 300 is removed, the connector 11 seals the space between the anatomical walls 3, 4 until the intracellular device 300 is reinserted.

[0072] In a preferred embodiment, delivery of the intracorporeal device 300 is via echo-guided transseptal and / or transaortic techniques for specific puncture sites, and echo-planes can be used for all puncture sites. Echo-planes are predefined projections / fields of view with predefined anatomical structures and angles to visualize specific regions of interest in a specific way. Echo-guided techniques can be, for example, intracardiac, transesophageal, or transthoracic.

[0073] Coupler 330 is positioned over the crown connector / coupling member (not visible) of intracorporeal device 300 and abuts end portion 332 of intracorporeal device 300 .

[0074] The control means 304 comprises a drive line 308 that houses cabling for powering and / or controlling the intracorporeal device 300. In this example, the control means 304 is coupled to a proximal portion 310 of the intracorporeal device 300 via a tapered portion 312. The tapered portion 312 tapers in size away from the proximal portion 310 of the intracorporeal device 300. The tapered portion 312 has the advantage of reducing strain on a connector interface (not shown) housed in a section 314 between the proximal portion 310 and the tapered portion 312. The connector interface couples the cabling within the control means 304 to a motor 316. The motor 316, the connector interface and the control means 304 form a sealed unit arranged to prevent fluid ingress.

[0075] A portion of the motor 316 is located within a rear portion 318 of the pump housing 320. The rear portion 318 of the pump housing 320 defines a number of irrigation holes 322, also referred to as bore portions, that allow fluid, such as blood, to flow through the rear portion 318 of the pump housing between a drive portion (not shown) of the motor 316 and a motor coupling element 324, which is partially visible in this view. A fluid inlet 326 is located within the rear portion 318 of the pump housing 320. Between the fluid inlet 326 and the fixation means 302 is an impeller (not shown) located within a front portion 328 of the pump housing 320.

[0076] A crown connector / coupling member (not shown) acts as the primary fluid outlet for intracorporeal device 300. A static diffuser 305 (partially visible) inside the crown connector / coupling member interferes with fluid flow to create the desired fluid flow from the primary outlet into the aorta. The crown connector / coupling member includes one or more fluid outlet ports 303.

[0077] In some other embodiments, such as the embodiment of Figure 1, the securing means 302 may be eliminated. In these embodiments, the crown connector / coupling member may also be eliminated. Thus, the diffuser 305 may be located within the distal end of the front portion 328 of the pump housing 320, rather than inside the crown connector / coupling member.

[0078] In this example, the distal portion of intracorporeal device 300 comprises fixation means 302 and a crown connector / coupling member (not shown), and during use, the distal portion resides within the aorta. The intermediate portion of intracorporeal device 300 comprises pump housing 320 with associated elements such as an impeller, and motor coupling element 324. The proximal portion of intracorporeal device 300 comprises the portion of the motor not within pump housing 320, portion 314, tapered portion 312, and control means 304.

[0079] Referring to FIG. 4, the intracorporeal device 300 from FIG. 3 is shown without the fixation means 302 coupled thereto. Thus, in this example, the crown connector / coupling member 331 can be seen in more detail. The crown connector 331 comprises a static diffuser 305 coupled to a sidewall of the crown connector 331. The diffuser comprises static blades 404 and a guidewire holder 402. During use, fluid flows over the static blades 404 of the static diffuser 305, and the blades are oriented to affect the direction of the fluid as it flows through the crown connector 331 and into one or more fluid exit ports 303. The guidewire holder 402 also allows for enhanced guidewire and / or balloon connectivity. For example, a guidewire (not shown) can be threaded through the guidewire holder 402 to enable precise placement of the intracorporeal device 300 within the human body, for example, via a catheter-based implantation method.

[0080] In some examples, the crown connector 331 can be eliminated and the static diffuser 305 can be located in the front portion 328 of the pump housing 320 .

[0081] Referring again to FIG. 4 , portion 314 is shown, allowing for the connector interface 406 to be seen. The connector interface 406 electrically couples the control means 304 to the rear end of the motor, thereby enabling power and / or control of the motor 316. The tapered portion 312 reduces strain on the connector interface 406. This is particularly important in the present invention because the intracorporeal device 300 must remain flexible. This is because, during use, the intracorporeal device 300 is implanted within the left and right atria and aorta of the heart via a catheter-based insertion system. As such, the intracorporeal device must be flexible enough to follow the directions of the arterial system. Portion 314 maintains the hermeticity of the motor 316 while allowing the coupling of the control means 304 and the motor 316 so that the motor can be implanted within the circulatory system of the human body.

[0082] Referring to Figure 5, a schematic diagram of intracorporeal device 500 is shown. In this example, power and control means are not shown. Furthermore, in this example, intracorporeal device 500 is shown without fixation means 302 or crown connector / coupling member 331. Thus, diffuser 534 is located at outlet 503 of intracorporeal device 500, rather than crown connector / coupling member 331 as shown in Figures 3 and 4.

[0083] Figure 5A shows an exterior view of intracorporeal device 500, while Figure 5B shows an interior view of intracorporeal device 500. Figure 5C shows diffuser 534, and Figure 5D shows an alternative impeller design.

[0084] The intracorporeal device 500 of Figure 5A comprises a motor 502 and a pump housing 504. A portion of the motor 502 is located within the pump housing 504. The intracorporeal device of Figure 5A comprises a proximal portion 506, an intermediate portion 508, and a distal portion 510, as previously discussed.

[0085] The portion of the pump housing 504 that houses parts of the motor comprises several bore portions which may also be flushing holes / slits 512. The pump housing 504 further comprises several fluid inlets 514.

[0086] Referring to FIG. 5B, it can be seen that a gap space 516 exists between the motor 502 and the motor coupling element 518. The dotted line represents the portion of the motor 502 that extends inside the motor coupling element 518. In this example, this portion is associated with an enclosed motor drive shaft 520. A bearing 522 couples the enclosed motor drive shaft 520 to the motor coupling element 518. The enclosed motor drive shaft 520 inside the motor coupling element 518 is of a smaller diameter than the motor coupling element 518, and the motor coupling element 518 is suspended around the enclosed motor drive shaft 520 with the aid of the bearing 522 and a magnetic field generated by one or more magnetic elements on the motor drive shaft 520 and within the motor coupling element 518. In this example, the enclosed motor drive shaft 520 inside the motor coupling element 518 includes a magnet or series of magnets (not shown) of a first polarity. The motor coupling element 518 includes a magnet or series of magnets of a second polarity, the first and second polarities being different. Thus, a clearance space is maintained between the portion of the enclosed motor drive shaft 520 inside the motor coupling element 518 and the portion of the motor coupling element 518 that surrounds the enclosed motor coupling element 518. This can be best seen in FIG.

[0087] The magnetic coupling between the magnets on the motor drive shaft 520 and the motor coupling element 518 has the advantage that the movement of the motor drive shaft 520 can be replicated by the motor coupling element 518 without exposing the motor drive shaft 520 to fluid. Again, this functionality can be better understood from Figure 6. This keeps the motor 502 sealed, allowing it to operate in a fluid environment.

[0088] An additional benefit of the magnetic coupling between the magnet on the motor drive shaft 520 and the motor coupling element 518 is that the motor 502 and any associated control means (not shown, see 304 in FIGS. 3 and 4 ) can be decoupled from the rest of the intracorporeal device 500 when the device is located within the body. Thus, portions of the intracorporeal device 500 that are likely to require removal, replacement, or modification, such as the motor 502 and cabling, can be removed and replaced while associated elements, such as the pump housing 504 and motor coupling element 518, remain in place within the body. This has the advantage of reducing movement and repositioning of the pump housing 504, which may be positioned between anatomical walls of the patient's heart, such as the left and right atria and aorta. Mechanical movement and / or repositioning of the pump housing 504 relative to the anatomical walls of the patient's heart may, in some circumstances, involve a risk of damage to said anatomical walls.

[0089] In this example, several split arms 524 surround bearing 522. The interface of split arms 524 couples motor coupling element 518 to impeller 526. Thus, motion of the magnet on motor drive shaft 520 can be transferred to impeller 526 without directly coupling the drive shaft of motor 502 or any other direct connection onto impeller 526. The split areas between arms 524 allow fluid to flow from interstitial space 516 and join with the fluid being pushed through impeller 526 via split arms 524.

[0090] In another example, the split arms 524 may be replaced by one or more boreholes in the motor coupling element. The boreholes and split arms may be collectively referred to as bore portions.

[0091] The arrangement of the motor 502 and motor coupling element 518 has several advantages, which are described below. During operation, the bearing 522 generates heat as it supports the movement of the motor coupling element 518 relative to the enclosed motor drive shaft 520. Fluid can flow through the clearance space 516 between the motor 502 and the motor coupling element 518 to cool the bearing 522. The split arms 524 and / or boreholes allow fluid to flow away from the bearing 522. Thus, fluid can flow through the wash holes 512 into the clearance space 516, cool the bearing 522, and mix with fluid being drawn into the impeller 526 via the fluid inlet 514. This allows the bearing 522 to cool without significantly increasing its temperature to a point where it could be damaged. Without the split arms 524 or boreholes, fluids such as blood would not be able to easily flow past the bearing 522. Therefore, heat transfer from the bearing 522 to the fluid would increase the temperature of the fluid, potentially causing damage. A two-degree increase in blood temperature can cause blood damage and / or clotting. These clots can migrate and move around the circulatory system, causing unwanted blockages.

[0092] In another example, the split arms 524 may be joined together to form a continuous arm. In this example, one or more bores may be present to allow for fluid flow from the motor coupling element 518.

[0093] Preferably, bearing 522 is formed from a ceramic material, which has the advantages of requiring less cooling as well as being resistant to heat buildup and wear, which in turn transfers less heat to the fluid, thereby reducing localized heating of the fluid and / or surrounding tissue.

[0094] As discussed above, the impeller 526 is coupled to the motor coupling element 518 via the segmented arms 524. In another example, the segmented arms are joined together and the impeller is coupled to the motor coupling element 518 via a continuous arm.

[0095] In operation, impeller 526 rotates about its axis 528, drawing fluid into the pump housing through fluid inlet 514 and split arms 524 (through gap space 516). Impeller 526 comprises a body 530 and a number of blades 532. Blades 532 push fluid past impeller 526 and into the pump housing at a velocity determined by the rotational speed of impeller 526.

[0096] Preferably, the body 530 of the impeller 526 is tapered, increasing from the motor coupling element 518 end to a mid-region of the impeller before decreasing again toward the outlet end of the intracorporeal device 500. The tapered body is thus elliptical in shape relative to the longitudinal axis of the impeller. The taper of the body 530 of the impeller 526 increases fluid pressure within the pump housing around the impeller 526. This results in less time for the fluid to spend around portions of the motor 502 that generate heat, thereby reducing blood damage / clotting in and / or around the intracorporeal device 500.

[0097] In this example, diffuser 534 is coupled to the outlet end of impeller 526 via bearing 536. Bearing 536 may be similar to bearing 522. Bearing 536 allows impeller 526 to rotate about its axis while being supported by diffuser 534. Diffuser 534 is coupled to a wall of housing 504 so as not to rotate. An end portion 538 of diffuser 534 is disposed at outlet 503 of pump housing 504.

[0098] As shown in FIG. 5C , the diffuser 534 comprises a body 539, several blades 535 coupled to the body 539, and a guidewire holder 541. The guidewire holder 541 allows a guidewire and / or balloon to be coupled to the intracorporeal device 500. Preferably, the diffuser comprises four blades 535. The blades 535 vary in thickness and orientation relative to the body 539 of the diffuser 534. The blades 535 curve either away from or toward the body 539. The thickness of the blades 535 varies as they move away from the body 539 of the diffuser. The thick / thin shape of the blades 535, combined with the angle of the blades 535, allows for optimal diffusion of fluid from the outlet of the intracorporeal device 500. Thus, the thickness, shape, and angle of the blades 535 are optimized to minimize blood damage and maximize pressure generation inside the intracorporeal device 500.

[0099] The overall operation of the intracorporeal device 500 will now be described. The hermetically sealed motor drive shaft 520 rotates about its longitudinal axis, causing the magnets on the motor drive shaft and the motor coupling element 518 to rotate relative to each other, which in turn causes the impeller 526 to rotate about its longitudinal axis while the diffuser 534 remains in a fixed position. During use, the proximal portion 506 is positioned within the right atrium. The intermediate portion 508, including the irrigation holes / slits 512 and the fluid inlet 514, is positioned within the left atrium. The distal portion, including the outlet of the intracorporeal device 500, is positioned within the aorta. Thus, the pump housing 504 is positioned between the wall of the left atrium 3 and the aortic wall 4 (see FIG. 1 ). The connector 11 seals the wall of the left atrium 3 and the aortic wall 4 around the pump housing 504, effectively providing a fluid seal. Thus, fluid, such as blood, can only flow between the wall of the left atrium 3 and the aortic wall 4 through the intracorporeal device 500 when the device is operating at full capacity. The impeller 530 draws fluid into the pump housing 504 via the fluid inlet 514, interstitial space 516, and associated split arms 524. The tapered design of the body 530 of the impeller 526 increases fluid pressure within the pump housing 504. The impeller blades 532 generate axial fluid flow through the impeller 526, and the diffuser 534 optimally directs fluid flow / diffusion to the exit of the pump housing 504 and into the aorta. As discussed above, the length of the pump housing 504 and components is designed so that one or more fluid inlet ports are in the left atrium and one or more fluid outlet ports are in the aorta.

[0100] In instances where the intracorporeal device 500 is operating at a partial capacity, for example to provide partial support to the patient's heart, there may be a partial flow of fluid, such as blood, through the left ventricle.

[0101] 5D , an alternative impeller 550 is shown. In this example, the alternative impeller, designated a “mixed flow” impeller 550, is shown coupled to a motor coupling element 518 via a split arm 524. The mixed flow impeller 550 comprises a first set of blades 552 and a second set of blades 554, the first set of blades 552 being longer than the second set of blades 554. The differently shaped and angled blade distribution gives the mixed flow impeller 550 an axial outlet as well as a partial radial outlet. Thus, the mixed flow impeller generates both axial and radial flow of fluid toward the outlet of the intracorporeal device 500. This has the advantage of increasing the efficiency of the intracorporeal device 500 because the mixed flow impeller 550 provides a higher output pressure compared to an axial flow impeller. A further advantage of the mixed flow impeller 550, in contrast to the impeller 530, is that an intracorporeal device 500 utilizing this impeller 550 does not require a diffuser 534, thereby reducing the overall length.

[0102] Optionally, a diffuser similar to diffuser 534 may be optionally coupled to mixed flow impeller 550 .

[0103] Figure 6A shows a schematic diagram of a radial coupling between a motor and a motor coupling element that may be utilized in an intracorporeal device, and Figure 6B shows a schematic diagram of an axial coupling between a motor and a motor coupling element that may be utilized in an intracorporeal device. Both Figures 6A and 6B include a diffuser 634 between the main outlet of the intracorporeal device 600, 640 and the impeller 632. Therefore, the fixation means 302 and the crown connector / coupling member 331 are not shown.

[0104] Referring to FIG. 6A, a cross section of an intracorporeal device 600 is shown. A motor 602 includes a motor drive shaft 604 that extends within a portion of the motor that is partially surrounded by a motor coupling element 606. The end of the shaft 604 includes a first set of magnets 608 of a first polarity. The first set of magnets 608 are housed within a sealed unit 610 that encapsulates the magnets 608 and the drive shaft. The motor coupling element 606 partially surrounds the sealed unit 610, and a second set of magnets 615 of opposite polarity is located within the motor coupling element 606. A bearing 612 rotatably couples the motor coupling element 606 to the sealed unit 610. The opposing magnetic fields generated by the first set of magnets 608 and the second set of magnets 615 attract each other, thus pulling the motor coupling element 606 toward the sealed unit 610. The magnets surround the entire periphery of the sealed unit 610 and the motor coupling element 606, such that there is an equal magnetic force that prevents the interfaces of the sealed unit 610 and the motor coupling element 606 from touching, thereby creating a gap space between the sealed unit 610 and the motor coupling element 606. During use, fluid, such as blood, flows into the gap space 614 between the motor 602 and the motor coupling element 606, through the gap space defined by the sealed unit 610 and the motor coupling element 606, and exits through the gap between the split arms 616. Thus, the bearing 612 is "washed" with fluid, preventing it from generating excessive heat. Due to the flow of fluid from the gap space 614 to the split arms 616, the bearing 612 does not generate localized heating or heat the fluid as it "washes" the bearing 612.

[0105] Additionally, fluid flows 617 into fluid inlet 618 and mixes with fluid 619 exiting between split arms 616. As discussed above, split arms 616 may be replaced with continuous arms having one or more boreholes to achieve the same fluid flow effect.

[0106] In this example, magnet 608 on drive shaft 604 rotates along the axis of shaft 604, resulting in an associated rotation of magnet 615 within motor coupling element 606. This radial coupling eliminates axial forces within the coupling assembly, resulting in a higher torque rating compared to axially coupled devices (discussed in FIG. 6B). Additionally, bearing 612 has less friction compared to axially coupled devices.

[0107] 6B, a cross section of an axially coupled intracorporeal device 640 is shown, comprising a motor housing portion 650 and a pump portion 651. In this example, a first magnet 652 of a first polarity is positioned on the end of a motor shaft 654 within the motor housing portion 650. A second magnet 656 of a second, different polarity is positioned opposite the first magnet within the pump portion 651, such that movement of the shaft 654, and therefore the first magnet 652, is replicated by the second magnet 656. This type of coupling is defined as an axial coupling.

[0108] A clearance space 670 is defined between the motor housing portion 650 and the pump portion 651, similar to that discussed with respect to Figure 6A. The clearance space allows fluid to flow 671 around bearings 672 that support the pump portion 651 relative to the motor housing portion 650.

[0109] An axial coupling is simpler to design than the radial coupling shown in Figure 6A. This type of indirect coupling maintains a sealed motor and allows torque transfer between the motor and impeller drive shaft 658. Additionally, an axial coupling is easier to manufacture because the magnetic elements are not as thin as those required for a radial coupling.

[0110] Referring to FIG. 7, an example of the split arm from FIG. 6 is shown. Split arm 702 couples impeller 704 to motor coupling element 706. The area / void between split arms 702 allows fluid to "wash" past bearings (not shown). Thus, fluid can flow in the gap space between the enclosed motor drive shaft (not shown) and motor coupling element 706. This has the advantage of cooling the device and maintaining fluid flow to prevent damage and / or solidification. Fluid output from the void in split arm 702 mixes with fluid drawn into the pump housing (not shown) during impeller rotation. The combined fluid flows axially through impeller 704.

[0111] Referring to Figure 8, there is shown an exploded view of intracorporeal device 800. The described components of Figures 6A and 6B are used to put the individual features into context.

[0112] The motor 802 includes a motor shaft 803, which is housed inside a sealed unit 804 and a sealing conduit 806. The sealed unit 804 corresponds to the sealed unit 610 of FIG. 6A. The sealed unit 804 is hollow to allow the motor shaft 803 and a magnet (not shown) to rotate within the sealed unit. The sealing conduit 806 houses the sealed unit 804 and a portion of a motor coupling element 812. In this example, the sealing conduit 806 provides the air gap 614 of FIG. 6A to allow fluid to enter the gap between the motor coupling element 606 and the sealed unit 610 from FIG. 6A.

[0113] The bearing 808 is associated with the bearing 612 from FIG. 6A and is positioned to rotatably couple the sealed unit 804 to the motor coupling element 812, thereby allowing rotation of the motor coupling element 812 about the bearing 808 axis. The magnetic component 810 is associated with the second magnet 615 located within the motor coupling element 606 from FIG. 6A. The magnetic component 810 is fixably attached to the motor coupling element 812 such that movement of the magnet in the sealed unit 804 is transferred to the motor coupling element 812. The impeller 814 is coupled to the motor coupling element 812 such that movement of the magnet in the sealed unit 804 is also transferred to the impeller 814. The diffuser 818 is coupled to the impeller 814 and to the pump housing 816 via bearings (not shown). The impeller 814 rotates about its longitudinal axis, while the diffuser 818 remains fixed. The pump housing 816 is disposed around the components, as shown with respect to FIG. 6A.

[0114] Optionally, the bearings discussed above, for example bearing 808, may be hydraulic bearings or a combination of ceramic and hydraulic bearings, where the base of the bearing (motor side) may be ceramic and the top of the bearing (outlet side) may be hydraulic.

[0115] Optionally, the diffuser 818 may be disposed within a crown connector / coupling member (not shown), such as the crown connector 331 from FIG.

[0116] Although the present invention has been described with respect to treatment from the left atrium to the aorta, the system and method may also be applied to other delivery sites, including, but not limited to, right atrium-to-aorta, vena cava-to-pulmonary artery, and vena cava-to-vena cava. Thus, the present invention may be broadly applied as a left ventricular assist device (LVAD), right ventricular assist device (RVAD), or biventricular assist device (BiVAD), for example, cardiopulmonary support (CPS), or intracorporeal membrane oxygenation (ICMO) or bubble oxygenation, or for treatment of other organs with pressure problems (e.g., gastric or neurological procedures). The present invention is versatile and therefore has a wide range of possible applications.

[0117] Thus, from the above description, it can be seen that the present invention provides a connector for establishing fluid communication between two anatomical compartments. This connector also allows a pump or other medical device to be securely implanted into one or more anatomical walls. This can be accomplished precisely and safely. The present invention provides a device that can establish fluid communication with minimal risk of blood leakage during the implantation procedure while providing support to the anatomical walls and tissues to prevent injury to the patient. [Item of invention] [Item 1] 1. A method for supporting cardiac function in a patient, comprising the step of securing an intracorporeal device across at least two anatomical walls of the heart, at least one anatomical wall being an endocardial wall and at least one anatomical wall being an ectocardial wall. [Item 2] Item 10. The method of item 1, wherein the at least one endocardial wall is the atrial septum and the at least one endocardial wall is the wall of the left atrium. [Item 3] Item 10. The method of item 1, comprising the step of anchoring the intracorporeal device across at least a third anatomical wall. [Item 4] 4. The method of any one of items 1 to 3, wherein the intracorporeal device comprises a proximal portion to be positioned in a first anatomical compartment, an intermediate portion to be positioned in a second anatomical compartment, and a distal portion to be positioned in a third anatomical compartment. [Item 5] 5. The method of claim 4, wherein the intracorporeal device is a fluid regulating device for assisting fluid flow from the second compartment to the third compartment. [Item 6] 6. The method of any one of items 1 to 5, wherein the intracorporeal device is secured to one or more anatomical walls by a connector. [Item 7] Item 7. The method of item 6, wherein the connector comprises a neck to be positioned across one or more anatomical walls, a first plurality of arms extending from a first end of the neck, and a second plurality of arms extending from a second end of the neck. [Item 8] Item 10. The method of claim 1, wherein the fixing means is integrally formed with or coupled to the intracorporeal device. [Item 9] Item 9. The method of item 8, wherein the fixation means comprises a plurality of arms extending from the intracorporeal device. [Item 10] Item 7. The method of item 6, wherein the intracorporeal device comprises one or more recesses adapted and configured to receive one or more anatomical walls. [Item 11] An intracorporeal device for assisting cardiac function in a patient, the intracorporeal device adapted and configured to be secured across at least two anatomical walls of the heart. [Item 12] Item 12. The intracorporeal device according to item 11, wherein at least one anatomical wall is an endocardial wall and at least one anatomical wall is an ectocardial wall. [Item 13] the intracorporeal device by a connector configured to be positioned across one or more anatomical walls; and Optionally, by fixation means integrally formed with or coupled to said intracorporeal device; Item 12. The intracorporeal device according to item 11, adapted and configured to be fixed to one or more anatomical walls. [Item 14] Item 14. The intracorporeal device according to item 13, wherein the fixing means comprises a plurality of arms extending from the intracorporeal device. [Item 15] Item 12. The intracorporeal device of item 11, wherein the intracorporeal device comprises one or more recesses adapted and configured to receive one or more anatomical walls. [Item 16] Item 12. The intracorporeal device of item 11, comprising a proximal portion to be positioned in a first anatomical compartment, an intermediate portion to be positioned in a second anatomical compartment, and a distal portion to be positioned in a third anatomical compartment. [Item 17] Item 17. The intracorporeal device of item 16, comprising a motor disposed within the proximal portion, one or more fluid inlet ports within the intermediate portion, a pump within the intermediate portion, and one or more fluid outlet ports within the distal portion. [Item 18] Item 18. The intracorporeal device of item 17, wherein the pump comprises an impeller and a pump housing, the impeller being disposed within the pump housing. [Item 19] Item 19. The intracorporeal device of item 18, wherein the impeller has a tapered shape that is greatest at a central portion of the impeller. [Item 20] Item 18. The intracorporeal device according to item 17, comprising a static diffuser disposed within the distal portion and in front of the one or more fluid exit ports. [Item 21] Item 17. The intracorporeal device according to item 16, comprising a coupling member at the end of the distal portion. [Item 22] 22. The intracorporeal device of claim 21, wherein the coupling member comprises a static diffuser. [Item 23] 22. The intracorporeal device according to item 21, wherein the coupling member facilitates coupling of the fixing means. [Item 24] 21. The intracorporeal device of claim 20, wherein the static diffuser is disposed between the impeller and the one or more fluid outlet ports. [Item 25] Item 18. The intracorporeal device of item 17, comprising a motor coupling element configured to couple a drive shaft of the motor to the pump. [Item 26] 26. The intracorporeal device of claim 25, wherein the motor coupling element magnetically couples the drive shaft of the motor to the pump. [Item 27] Item 27. The intracorporeal device of item 26, wherein the motor coupling element axially couples the drive shaft of the motor to the pump. [Item 28] Item 27. The intracorporeal device of item 26, wherein the motor coupling element radially couples the drive shaft of the motor to the pump. [Item 29] 26. The intracorporeal device of claim 25, wherein the motor, the drive shaft, and the magnetic element at the end of the drive shaft are located within a sealed housing. [Item 30] 30. The intracorporeal device of claim 29, wherein a portion of the motor coupling element surrounds a portion of the hermetically sealed housing that houses the magnetic element. [Item 31] Item 31. The intracorporeal device of item 30, wherein a gap space exists between the portion of the motor coupling element and the portion of the hermetic housing. [Item 32] 26. The intracorporeal device of claim 25, wherein the motor coupling element interface is magnetically securable to the motor interface for coupling the drive shaft to the pump, and an air gap exists between the interfaces during coupling. [Item 33] Item 33. The intracorporeal device of item 32, wherein, in use, the gap facilitates fluid flow between the motor interface and the interface of the motor coupling element. [Item 34] Item 33. The intracorporeal device of item 32, wherein a further interface of the motor coupling element couples to an interface of the impeller. [Item 35] Item 26. The intracorporeal device of item 25, wherein the motor coupling element comprises one or more bore portions. [Item 36] Item 36. The intracorporeal device of item 35, wherein the one or more bore portions comprise a borehole extending through the motor coupling element. [Item 37] Item 36. The intracorporeal device of item 35, wherein the one or more bore portions comprise split arms coupling the interfaces of the motor coupling element to respective impeller interfaces. [Item 38] Item 36. The intracorporeal device of item 35, wherein, in use, fluid flows between the motor interface and the interface of the motor coupling element and through the one or more bore portions toward the impeller. [Item 39] Item 36. The intracorporeal device according to item 35, wherein the one or more fluid inlet ports are disposed between the one or more bore portions and the impeller. [Item 40] Item 18. The intracorporeal device according to item 17, wherein the motor comprises a power source and a control means. [Item 41] Item 41. The intracorporeal device of item 40, wherein the power source and control means are coupled to the motor via a tapered portion.

Claims

1. An intracorporeal device (1) for supporting cardiac function in a patient, comprising: adapted and configured to be anchored across at least two anatomical walls of the heart using a two-point anchoring system; The intracorporeal device comprises a proximal portion (5) to be disposed in a first anatomical compartment, an intermediate portion (6) to be disposed in a second anatomical compartment, and a distal portion (7) to be disposed in a third anatomical compartment; The intracorporeal device comprises a motor (M) disposed in the proximal portion, one or more fluid inlet ports (8) in the intermediate portion, a pump (P) in the intermediate portion, and one or more fluid outlet ports (9) in the distal portion.

2. The intracorporeal device of claim 1 , wherein at least one anatomical wall is an endocardial wall and at least one anatomical wall is an ectocardial wall.

3. the intracorporeal device by a connector (11) configured to be placed across one or more anatomical walls; and Optionally, by fixation means integrally formed with or coupled to said intracorporeal device; The intracorporeal device of claim 1 , adapted and configured to be secured to one or more anatomical walls.

4. 4. The intracorporeal device of claim 3, wherein the fixation means comprises a plurality of arms (15) extending from the intracorporeal device.

5. The intracorporeal device of claim 1 , wherein the intracorporeal device comprises one or more recesses (10) adapted and configured to receive one or more anatomical walls.

6. The intracorporeal device of claim 1 , wherein the pump comprises an impeller (526) and a pump housing (504), the impeller being disposed within the pump housing.

7. The intracorporeal device of claim 6 , wherein the impeller comprises a tapered shape that is greatest at a central portion of the impeller.

8. The intracorporeal device of claim 1 , comprising a static diffuser (534) disposed within the distal portion and in front of the one or more fluid exit ports.

9. The intracorporeal device of claim 8 , wherein the static diffuser is disposed between the impeller and the one or more fluid outlet ports.

10. The intracorporeal device of claim 1 , comprising a motor coupling element (518) configured to couple a drive shaft of the motor to the pump.

11. The intracorporeal device of claim 10 , wherein the motor coupling element magnetically couples the drive shaft of the motor to the pump.

12. The intracorporeal device of claim 11 , wherein the motor coupling element axially couples the drive shaft of the motor to the pump.

13. The intracorporeal device of claim 11 , wherein the motor coupling element radially couples the drive shaft of the motor to the pump.

14. The intracorporeal device of claim 10 , wherein the motor, the drive shaft, and the magnetic element at the end of the drive shaft are located within a sealed housing.

15. The intracorporeal device of claim 14 , wherein a portion of the motor coupling element surrounds a portion of the hermetic housing that houses the magnetic element.

16. 16. The intracorporeal device of claim 15, wherein a gap space exists between the portion of the motor coupling element and the portion of the hermetic housing.

17. 11. The intracorporeal device of claim 10, wherein the motor coupling element interface is magnetically securable to the motor interface for coupling the drive shaft to the pump, and an air gap exists between the interfaces during coupling.

18. 18. The intracorporeal device of claim 17, wherein, in use, the gap facilitates fluid flow between the motor interface and the interface of the motor coupling element.

19. The intracorporeal device of claim 17 , wherein a further interface of the motor coupling element couples to an interface of the impeller.

20. The intracorporeal device of claim 10 , wherein the motor coupling element comprises one or more bore portions.

21. The intracorporeal device of claim 20 , wherein the one or more bore portions comprise a borehole extending through the motor coupling element.

22. 21. The intracorporeal device of claim 20, wherein the one or more bore portions comprise split arms that couple the interface of the motor coupling element to a respective impeller interface.

23. 21. The intracorporeal device of claim 20, wherein, in use, fluid flows between the motor interface and the interface of the motor coupling element and through the one or more bore portions toward the impeller.

24. 21. The intracorporeal device of claim 20, wherein the one or more fluid inlet ports are disposed between the one or more bore portions and the impeller.

25. The intracorporeal device of claim 1 , wherein the motor comprises a power source and a control means.

26. 26. The intracorporeal device of claim 25, wherein the power source and control means are coupled to the motor via a tapered portion.

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