Patent Description:
Known mechanical devices, such as left ventricle assist devices ("LVAD") or intra-aortic balloon pumps ("IABP") can be used to supplement the heart's pumping ability. LVADs are surgically implanted into the chest cavity and provide blood flow from left ventricle of the heart to the aorta. LVADs are often implanted in patients waiting for a heart transplant or as a temporary means to assist the patient in recovering from a temporary heart failure. In some instances, LVADs are implanted as a long-term solution for patients that are not eligible for a heart transplant. IABPs are catheter-based devices with a balloon that inflates inside the aorta when the aortic value is closed (i.e., during diastole) to force blood further into the circulatory system. These devices provide a temporary augmentation of the heart function via a balloon/pump internally connected to the driver outside the body via a catheter.

Intravenous pumps connected to a stent by means of strut elements are known in the prior art, e.g. <CIT>.

Although such circulatory-assist devices can effectively supplement the output of the heart, they are not without significant risks. For example, known methods for implanting LVADs require invasive surgical procedures. Specifically, some known methods of implanting LVADs involve open heart surgery (e.g., a midline sternotomy of the chest and utilization of cardiopulmonary bypass). Known methods of implanting circulatory assist devices often include surgical incisions into the heart, which may further weaken the heart. Moreover, because patients in need of a circulatory assist device are usually suffering from chronic congestive heart failure, they are often even more susceptible to complications during and after surgery. Accordingly, the survival rate for LVAD patients one year after implantation is only about <NUM> percent (<NPL>).

In addition to surgical risks, known circulatory-assist devices include components, such as the pump, that are implanted within the patient's body, and components, such as the controller and power source, that remain outside of the patient's body. The internal and external components are connected using electrical leads or a "driveline" that extends from inside of the body to the external power supply. Such connections are susceptible to infection and can further complicate the use of LVADs as a long-term solution.

To reduce the surgical risks associated with circulatory-assist devices and LVADs, there have been some attempts made to deliver pumps endovascularly, but these also have significant disadvantages. For example, because of the difficulty in traversing the aortic arch, some known procedures including implanting a pump in the descending aorta. Including the inflow cannula downstream of the aortic arch, however, minimizes the effects of the circulatory-assist system on the caudal regions of the patient.

Some known designs and methods include placing a pump within a cage, for example, a structure similar to a vena cava filter, and advancing the pump into the ascending aorta. Such methods, however, employ cages having "hooks" or other single points of attachment to the vessel wall. Accordingly, such systems are susceptible to downstream migration, tipping, and perforating the vessel walls (see, e.g., <NPL>). Moreover, the added weight of suspending a pump within such systems will likely exacerbate such issues.

Moreover, there are no effective techniques for the removal of such implanted pumps using endovascular procedures. For example, the likelihood of effective removal of system that includes a hook or anchor point in direct contact with the vessel wall can decrease with time. Specifically, support systems in direct contact can be subject to endothelialization of the anchor points, which increases the risk of perforating the vessel wall during removal.

Thus, a need exists for improved intracardiac pump assemblies and methods for implantation and removal of intracardiac pump assemblies using endovascular procedures.

The invention is defined by the appended clams. Embodiments not falling within the scope of the claims are exemplary. Intracardiac pump assemblies and methods for their implantation and removal are described herein. According to the invention, the apparatus includes an expandable member, a blood pump, and a set of struts. The expandable member is configured to transition from a collapsed configuration to an expanded configuration. The expandable member includes a set of flexible segments that form a tubular wall defining an interior volume. The flexible segments contact an inner surface of a blood vessel when the expandable member is in the expanded position. The expandable member includes a set of attachment portions. Each of the struts has a first end portion coupled to a housing of the blood pump. Each of the struts has a second end portion configured to be removably coupled to a corresponding attachment portion such that the blood pump can be removably coupled to the expandable member with at least a portion of the housing disposed within the interior volume of the expandable member. The second end portion of a strut from the plurality of struts is configured to be slidingly disposed within a slot defined by an attachment portion from the plurality of attachment portions. Alternatively, the second end portion of a strut from the plurality of struts defines the slot within which a protrusion of an attachment portion from the plurality of attachment portions is configured to be slidingly disposed.

In some embodiments not according to the invention, included for illustration purposes only, a method includes inserting into an entry blood vessel a retrieval sheath. The retrieval sheath is advanced through the entry blood vessel and to a target blood vessel. The retrieval sheath is then positioned about a proximal end portion of a blood pump from a blood pump assembly. The blood pump assembly includes the blood pump, an expandable member, and a set of struts. The expandable member includes a tubular wall in contact an inner surface of the target blood vessel and defining an interior volume. The expandable member includes a set of attachment portions. A first end portion of each strut is coupled to the blood pump, and a second end portion of each strut is coupled to a corresponding attachment portion such that at least a portion of the blood pump is within the interior volume of the expandable member and suspended within the target blood vessel. The method includes moving an end portion of the retrieval sheath distally relative to the blood pump to: A) remove the second end portion of each strut from its corresponding attachment portion, and B) place the blood pump and the set of struts within the retrieval sheath. The retrieval sheath, including the blood pump and the plurality of struts, is retracted from the target blood vessel.

Intracardiac pump assemblies and methods for their implantation and removal are described herein. According to the invention, the apparatus includes an expandable member, a blood pump, and a set of struts. The expandable member is configured to transition from a collapsed configuration to an expanded configuration. The expandable member includes a set of flexible segments that form a tubular wall defining an interior volume. The flexible segments contact an inner surface of a blood vessel when the expandable member is in the expanded position. The expandable member includes a set of attachment portions. Each of the struts has a first end portion coupled to a housing of the blood pump. Each of the struts has a second end portion configured to be removably coupled to a corresponding attachment portion such that the blood pump can be removably coupled to the expandable member with at least a portion of the housing disposed within the interior volume of the expandable member.

In some embodiments, an apparatus includes an expandable member, a blood pump, a power supply, and a set of struts. The expandable member is configured to transition from a collapsed configuration to an expanded configuration. The expandable member including a set of flexible segments that form a tubular wall defining an interior volume. The flexible segments are configured to contact an inner surface of a blood vessel when the expandable member is in the expanded position. The expandable member includes a set of attachment portions. The power supply is coupled to the blood pump and is configured to provide power to drive the blood pump. Each of the struts has a first end portion coupled to at least one of the blood pump or the power supply. Each of the struts has a second end portion configured to be removably coupled to a corresponding attachment portion such that the blood pump and the power supply can be removably coupled to the expandable member with at least one of a portion of the blood pump or a portion of the power supply disposed within the interior volume of the expandable member.

In some embodiments, kit includes a blood pump assembly and a set of expandable members. The blood pump assembly includes a housing and a set of struts. Each strut has a first end portion coupled to the housing. Each of the expandable members is configured to transition from a collapsed configuration to an expanded configuration. Each of the expandable members includes a set of flexible segments that form a tubular wall defining an interior volume. The flexible segments are configured to contact an inner surface of a blood vessel when the expandable member is in the expanded position. Each of the expandable members includes a plurality of attachment portions. Each of the struts has a second end portion configured to be removably coupled to a corresponding attachment portion of each expandable member such that the blood pump can be removably coupled to each expandable member with at least a portion of the housing disposed within the interior volume of the expandable member. The set of expandable members includes a first expandable member having a first size and a second expandable member having a second size. The first size is different than the second size.

In some embodiments not according to the invention, present for illustration purposes only, a method of implanting a blood pump assembly includes inserting into an entry blood vessel the blood pump assembly. The blood pump assembly includes a blood pump, an expandable member, and a set of struts. The expandable member includes a set of flexible segments that form a tubular wall defining an interior volume. The expandable member includes a set of attachment portions. A first end portion of each strut is coupled to the blood pump. A second end portion of each strut is removably coupled to a corresponding attachment portion such that at least a portion of the blood pump is within the interior volume of the expandable member. The inserting is performed when the expandable member is in a collapsed configuration. The blood pump assembly is advanced through the entry blood vessel and to a target blood vessel. The expandable member is then transitioned from the collapsed configuration to an expanded configuration such that the flexible segments contact an inner surface of the target blood vessel and the blood pump is suspended within the target blood vessel by the struts. The blood pump and the set of struts are configured to be removed from the target blood vessel by removing the second end portion of each strut from its corresponding attachment portion.

In some embodiments not according to the invention, present for illustration purposes only, a method includes inserting into an entry blood vessel a retrieval sheath. The retrieval sheath is advanced through the entry blood vessel and to a target blood vessel. The retrieval sheath is then positioned about a proximal end portion of a blood pump from a blood pump assembly. The blood pump assembly includes the blood pump, an expandable member, and a set of struts. The expandable member includes a tubular wall in contact an inner surface of the target blood vessel and defining an interior volume. The expandable member includes a set of attachment portions. A first end portion of each strut is coupled to the blood pump, and a second end portion of each strut is coupled to a corresponding attachment portion such that at least a portion of the blood pump is within the interior volume of the expandable member and suspended within the target blood vessel. The method includes moving an end portion of the retrieval sheath distally relative to the blood pump to: A) remove the second end portion of each strut from its corresponding attachment portion, and B) place the blood pump and the set of struts within the retrieval sheath. The retrieval sheath, including the blood pump and the plurality of struts, is retracted from the target blood vessel.

In some embodiments not according to the invention, present for illustration purposes only, a method includes inserting into an entry blood vessel a blood pump assembly that includes a blood pump, an inflow cannula, and an electrical lead. The blood pump assembly is advanced through the entry blood vessel and to an ascending aorta. The blood pump assembly is then affixed within the ascending aorta such that the inflow cannula is disposed through an aortic valve and within a left ventricle. The method further includes advancing a catheter through a superior vena cava and transseptally into the left ventricle. A proximal end portion of the electrical lead is captured, and a distal end portion of the lead is configured to be coupled to the blood pump. The proximal end portion of the electrical lead is retrieved through the superior vena cava, and is attached to a power supply located in a subcutaneous region of a body.

In some embodiments not according to the invention, present for illustration purposes only, a method includes inserting into an entry blood vessel a blood pump assembly that includes a blood pump and an inflow cannula. The blood pump assembly is advanced through the entry blood vessel and to an ascending aorta. The blood pump assembly is then affixed within the ascending aorta such that the inflow cannula is disposed through an aortic valve and within a left ventricle. The method further includes advancing a distal end portion of an electrical lead through a superior vena cava and transseptally into the left ventricle. The distal end portion of the lead is coupled to the blood pump. A proximal end portion of the electrical lead is configured to be coupled to a power supply located in a subcutaneous region of a body.

The term "about" when used in connection with a referenced numeric indication means the referenced numeric indication plus or minus up to <NUM> percent of that referenced numeric indication. For example, "about <NUM>" means from <NUM> to <NUM>.

The term "substantially" when used in connection with, for example, a geometric relationship, a numerical value, and/or a range is intended to convey that the geometric relationship (or the structures described thereby), the number, and/or the range so defined is nominally the recited geometric relationship, number, and/or range. For example, two structures described herein as being "substantially parallel" is intended to convey that, although a parallel geometric relationship is desirable, some non-parallelism can occur in a "substantially parallel" arrangement. By way of another example, a structure defining a volume that is "substantially <NUM> milliliters (mL)" is intended to convey that, while the recited volume is desirable, some tolerances can occur when the volume is "substantially" the recited volume (e.g., <NUM>). Such tolerances can result from manufacturing tolerances, measurement tolerances, and/or other practical considerations (such as, for example, minute imperfections, age of a structure so defined, a pressure or a force exerted within a system, and/or the like). As described above, a suitable tolerance can be, for example, of ± <NUM> percent of the stated geometric construction, numerical value, and/or range. Furthermore, although a numerical value modified by the term "substantially" can allow for and/or otherwise encompass a tolerance of the stated numerical value, it is not intended to exclude the exact numerical value stated.

As used herein, the term "set" can refer to multiple features or a singular feature with multiple parts. For example, when referring to set of walls, the set of walls can be considered as one wall with multiple portions, or the set of walls can be considered as multiple, distinct walls. Thus, a monolithically-constructed item can include a set of walls. Such a set of walls can include, for example, multiple portions that are either continuous or discontinuous from each other. A set of walls can also be fabricated from multiple items that are produced separately and are later joined together (e.g., via a weld, an adhesive, or any suitable method).

As used in this specification and the appended claims, the words "proximal" and "distal" refer to direction closer to and away from, respectively, an operator of the medical device or implant. Thus, for example, the end of an implant first contacting the patient's body (i.e., furthest away from the practitioner implanting the device) would be the distal end of the implant, while the end opposite the distal end would be the proximal end of the implant.

As used herein, the terms "blood vessel" or "vessel" include any structure within the body through which blood can flow to tissues and organs within the body, including any vein, artery, or capillary. For example, the term "blood vessel" can refer to a subclavian vein, a femoral artery, an ascending aorta, or any other structure within the human body.

For reference, <FIG> show various cross-sectional views of a human heart <NUM>, which is an organ that pumps blood through the body via the circulatory system. The blood provides oxygen and nutrients to the tissues and removes carbon dioxide and other wastes. The heart <NUM> has four chambers: two upper chambers (the left atrium <NUM> and the right atrium <NUM>) and two lower chambers (the left ventricle <NUM> and the right ventricle <NUM>). The right atrium <NUM> and the right ventricle <NUM> together make up the right heart and the left atrium <NUM> and left ventricle <NUM> make up the left heart. A wall of muscle called the septum <NUM> separates the two sides of the heart.

The heart has multiple valves that separate the chambers of the heart, and control the flow of blood through the various blood vessels through which blood flows into and out of the heart <NUM>. Specifically, the tricuspid valve <NUM> separates the right ventricle <NUM> from the right atrium <NUM>. Blood flows from the superior vena cava <NUM> and the inferior vena cava <NUM> and into the right atrium <NUM>. During diastole, the pressure in the ventricles drops, thus allowing the blood to flow from the right atrium <NUM> through the tricuspid valve <NUM> and into the right ventricle <NUM>. During systole, blood flows out of the right ventricle <NUM> and into the pulmonary arteries (the left pulmonary artery <NUM> is identified in <FIG>).

The mitral valve <NUM> separates the left ventricle <NUM> from the left atrium <NUM>. Oxygenated blood flows from the pulmonary veins and into the left atrium <NUM>. During diastole, the pressure in the ventricles drops, thus allowing the blood to flow from the left atrium <NUM> through the mitral valve <NUM> and into the left ventricle <NUM>. During systole, blood flows out of the left ventricle <NUM>, through the aortic valve <NUM> and into the aorta. The aorta includes the ascending aorta <NUM>, the aortic arch <NUM>, and the descending aorta <NUM> (see <FIG>). The aortic arch <NUM> supplies blood to the brachiocephalic artery <NUM>, the left common carotid artery <NUM> and the left subclavian artery <NUM>. Heartstrings (chordae tendinae) anchor the valves to the heart muscles. The sinoatrial nodes produce the electrical pulses that drive the heart contractions.

<FIG> are schematic illustrations of a blood pump assembly <NUM>, according to an embodiment. The blood pump assembly <NUM> is shown in a first configuration (<FIG>), a second configuration (<FIG> and <FIG>) and a third configuration (<FIG>). The blood pump assembly <NUM> includes a blood pump <NUM>, a set of struts <NUM>, and an expandable member <NUM>. The blood pump <NUM> can be any suitable device that pumps blood and provides the desired flow characteristics to supplement the output of the heart. For example, the blood pump <NUM> (and any of the blood pumps described herein) includes a pumping unit (not shown, e.g., an impeller, a roller, a balloon, or the like) enclosed within a housing <NUM>. The blood pump <NUM> produces any suitable blood flow rate, for example a flow rate of between <NUM> liters per minute and <NUM> liters per minute. In some embodiments, the blood pump <NUM> (or any of the blood pumps described herein) can produce a flow rate of between <NUM> liters per minute and <NUM> liters per minute. Moreover, the blood pump <NUM> (and any of the blood pumps described herein) can be configured to limit the amount of heat transfer into the blood, reduce and/or eliminate points of stasis, or the like. In some embodiments, the blood pump <NUM> can include a miniature axial heart pump. In some embodiments, the blood pump <NUM> (and any of the blood pumps described herein) can include a miniature pump similar to those developed by VADovations, Inc. , and disclosed in <CIT>, entitled "Heart Assist Device". In some embodiments, the assembly <NUM> can include a power supply (not shown) that is close-coupled to the blood pump <NUM>. Similarly stated, in some embodiments the assembly <NUM> (or any of the assemblies described herein) can include a power supply (battery, capacitance power supply, etc.) that can be disposed along with the blood pump <NUM> within the vasculature. In such embodiments, the assembly <NUM> (or any of the assemblies described herein) can also include a wireless charging system of the types shown and described herein (e.g., the wireless systems <NUM>, <NUM>).

The expandable member <NUM> is configured to transition from a collapsed configuration (<FIG>) to an expanded configuration (<FIG>), and includes a series of flexible segments <NUM>. The flexible segments <NUM> can be coupled together in any suitable pattern to form a tubular wall <NUM> having an outer surface <NUM> and an inner surface <NUM>, and that defines an interior volume <NUM>. The expandable member <NUM> can include any suitable number of flexible segments <NUM> in any suitable form, such as coiled members, longitudinal members, or the like. For example, in some embodiments, the flexible segments <NUM> can be braided or woven to produce the tubular wall <NUM> that can transition from the collapsed configuration to the expanded configuration. In some embodiments, the expandable member <NUM> can include multiple layers of flexible segments to produce the desired spring characteristics and strength. In yet other embodiments, the flexible segments <NUM> can be produced from a monolithic sheet of material (e.g., by a laser cutting process). Moreover, any the tubular wall <NUM> (and any of the tubular walls described herein) can have any suitable pore size (or arrangement of openings) so that the outer surface <NUM> provides the desired contact area within the bodily lumen. In this manner, as described herein, the expandable member <NUM> can be resistant to migration and can provide support for the blood pump <NUM> suspended within the interior volume <NUM>.

The expandable member <NUM> and the flexible segments <NUM> (and any of the expandable members described herein) can be constructed from any suitable material that provides the desired strength, spring characteristics and biocompatibility. For example, in some embodiments. The expandable member <NUM> (and any of the expandable members described herein) can be constructed from a metal, such as, for example, a medical grade stainless steel, a cobalt-based alloy, platinum, gold, titanium, tantalum, and/or niobium. In some embodiments, the expandable member <NUM> (and any of the expandable members described herein) can be constructed from a shape memory material, such as a nickel-titanium alloy (e.g., Nitinol®). In other embodiments, the expandable member <NUM> (and any of the expandable members described herein) can be constructed from a polymeric material, such as, for example, poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), poly(glycolide) (PGA), poly(L-lactide-co-D,L-lactide) (PLLA/PLA), polyethylene terephthalate (PET), poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), polydioxanone (PDS), Polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly(phosphazene)poly(D,L-lactide-co-caprolactone) PLA/PCL), poly(glycolide-co-caprolactone) (PGA/PCL), poly(phosphate ester), or the like.

As shown in <FIG>, when the blood pump assembly <NUM> is deployed within a blood vessel V and the expandable member <NUM> is in its expanded configuration, the outer surface <NUM> of the tubular wall <NUM> is in contact with the inner surface S of the blood vessel V. The expandable member <NUM> is sized and configured such that the outer surface <NUM> exerts a radially outward force on the inner surface S to maintain (or anchor) the expandable member <NUM> within the blood vessel. By providing the anchoring force circumferentially and along the axial length LC of the expandable member <NUM> (as opposed to multiple, discrete anchor points), the expandable member <NUM> and the blood pump assembly <NUM> are resistant to migration (i.e., movement along the longitudinal center line CL) within the blood vessel V. Similarly stated, the expandable member <NUM> distributes the radially outward anchoring force over the contact area of the outer surface <NUM>, thereby minimizing migration. This arrangement also minimizes and/or eliminates tipping (i.e., rotation about an axis non-parallel to the longitudinal center line CL). Moreover, by avoiding anchoring via discrete anchor points, the expandable member <NUM> and the blood pump assembly <NUM> reduces the likelihood of perforating the wall of the blood vessel V.

Referring to <FIG>, the expandable member <NUM> has a contact length LC over which the outer surface <NUM> of the tubular wall <NUM> is in contact with the inner surface S of the blood vessel V. The contact length LC can be any suitable distance to provide the desired anchoring and/or stability characteristics. For example, in some embodiments, the contact length LC can be equal to or greater than a length LP of the blood pump <NUM>. In other embodiments, the contact length LC can be less than a length LP of the blood pump <NUM>. For example, in some embodiments, the contact length LC can be at least about one quarter of the length LP of the blood pump <NUM>. In some embodiments, the contact length LC can be less than about three quarters of the length LP of the blood pump <NUM>. In some embodiments, the contact length LC can be less than about half of the length LP of the blood pump <NUM>. In some embodiments, the contact length LC can be less than about one quarter of the length LP of the blood pump <NUM>.

The expandable member <NUM> includes a series of attachment portions <NUM> to which a corresponding strut <NUM> can be removably and/or releasably coupled. In some embodiments, the attachment portions <NUM> (and any of the attachment portions described herein) can be a separate structure or mechanism that is coupled to the flexible segments <NUM> or tubular wall <NUM>. In other embodiments, the attachment portions <NUM> (and any of the attachment portions described herein) can be monolithically constructed with (or a portion of) the flexible segments <NUM> or tubular wall <NUM>. Although the expandable member <NUM> is shown as including four attachment portions <NUM>, in other embodiments, the expandable member <NUM> (and any of the expandable members described herein) can include any suitable number of attachment portions (e.g., between two and eight, between two and ten, or between two and <NUM>). Although the attachment portions <NUM> are shown as extending within the internal volume <NUM>, in other embodiments, the attachment portions <NUM> can be flush with the inner surface <NUM> of the tubular wall <NUM>. Similarly stated, in some embodiments, the tubular wall <NUM> and the set of attachment portions <NUM> define a continuous inner surface <NUM>.

The blood pump assembly <NUM> includes a set of struts <NUM>. Each strut <NUM> includes a first end portion <NUM> and a second end portion <NUM>. The first end portion <NUM> of each strut <NUM> is coupled to the pump <NUM>. More particularly, the first end portion <NUM> of each strut <NUM> is coupled to the housing <NUM> of the pump <NUM>. The first end portion <NUM> can be coupled to the housing <NUM> in any suitable manner. For example, in some embodiments, the first end portion <NUM> can be coupled by a pin joint or a ball joint, such that the strut <NUM> can rotate relative to the housing (e.g., when the expandable member <NUM> moves from its collapsed configuration to its expanded configuration). In other embodiments, the first end portion <NUM> can be coupled to the housing <NUM> by a band, weld joint, or adhesive. The second end portion <NUM> of each strut is removably coupled to its corresponding attachment portion <NUM> of the expandable member <NUM>. In this manner, the blood pump <NUM> can be removably coupled to the expandable member <NUM> by the set of struts <NUM>. More particularly, the blood pump <NUM> can be coupled to the expandable member <NUM> with at least a portion of the housing <NUM> disposed within the interior volume <NUM> of the expandable member <NUM>. Similarly stated, when the blood pump assembly <NUM> is in its first configuration and its second configuration, the blood pump <NUM> is suspended within the interior volume <NUM> by the set of struts <NUM>.

Because the second end portion <NUM> of each strut is removably (or releasably) coupled to the corresponding attachment portion <NUM>, the blood pump <NUM> and the struts <NUM> can be removed from the expandable member <NUM>. This arrangement allows the blood pump assembly <NUM> to be moved from the second configuration (<FIG> and <FIG>) to the third configuration (<FIG>). In this manner, the blood pump <NUM> and the struts <NUM> can be removed when the assembly <NUM> is within the body, for example, if the patient no longer needs the pump assembly <NUM>, if the blood pump <NUM> has malfunctioned, or the like. Moreover, as described in more detail below, the blood pump <NUM> and the struts <NUM> can be removed endovascularly by decoupling (or releasing) the struts <NUM> from the attachment portions <NUM>.

The struts <NUM> can be constructed from any suitable material that provides the desired strength to suspend the blood pump <NUM> within the blood vessel V. Moreover, the struts <NUM> are flexible and can change their length and/or orientation to allow the expandable member to transition from the collapsed configuration to the expanded configuration. For example, in some embodiments, the struts <NUM> can be constructed from a metallic material, such as, a medical grade stainless steel. In other embodiments, the struts <NUM> (and any of the struts described herein) can be constructed from a shape memory material, such as a nickel-titanium alloy (e.g., Nitinol®). In other embodiments, the struts <NUM> (and any of the struts described herein) can be constructed from a polymeric material, such as, for example, poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), poly(glycolide) (PGA), poly(L-lactide-co-D,L-lactide) (PLLA/PLA), polyethylene terephthalate (PET), poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), polydioxanone (PDS), Polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly(phosphazene)poly(D,L-lactide-co-caprolactone) PLA/PCL), poly(glycolide-co-caprolactone) (PGA/PCL), poly(phosphate ester), or the like.

In some embodiments, either of the attachment portions <NUM> or the second end portion <NUM> of the struts <NUM> can include a latch, a locking mechanism, or detent that maintains the struts <NUM> within the attachment portions <NUM> until a retrieval force threshold has been exceeded. This arrangement prevents the struts <NUM> from being inadvertently released or removed from the expandable member <NUM>.

Although the blood pump assembly <NUM> is shown as including four struts <NUM>, in other embodiments, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) can include any suitable number of struts (e.g., between two and eight, between two and ten, or between two and <NUM>).

In use, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) can be implanted into a patient's circulatory system to supplement the blood flow output of the heart. Because the blood pump <NUM> and the struts <NUM> can be removed from the expandable member <NUM>, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) is well suited for both short term and long term use. For example, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) can be implanted, and then removed within ten days, one month, two months, or less than one year when the patient no longer needs the circulatory assistance. As described herein, the blood pump <NUM> and the struts <NUM> can be removed (leaving the expandable member <NUM> behind) without obstructing the blood vessel. Similarly, when implanted for long-term use (e.g., one year, two years, or longer), the blood pump <NUM> and the struts <NUM> can be removed when there is a failure of the blood pump <NUM>, to replace the batteries (not shown) or the like.

To implant the blood pump assembly <NUM>, the assembly <NUM> is first inserted into an entry blood vessel (e.g., the femoral artery) endovascularly. Similarly stated, the assembly <NUM> is first inserted into an entry blood vessel (e.g., the femoral artery) using percutaneous and/or minimally invasive techniques. The blood pump assembly <NUM> is inserted when in its first (or collapsed) configuration, as shown in <FIG>. The blood pump assembly <NUM> is then advanced to a target blood vessel (identified as the blood vessel V in <FIG>). The target blood vessel V can be any suitable blood vessel, such as the descending aorta, the aortic arch, or the ascending aorta. The blood pump assembly <NUM> is then transitioned from its first (or collapsed) configuration to its second (or expanded configuration). When in the expanded configuration, the outer surface <NUM> of the tubular wall <NUM> contacts, engages and/or exerts a radially outward force upon the inner surface S of the blood vessel V, as described above. In this manner, the blood pump assembly <NUM> can be anchored in the desired location within the blood vessel V.

After being implanted, the blood pump <NUM> can be actuated (or powered) to supplement the blood flow provided by the patient's heart. In particular, the blood pump <NUM> (and any of the blood pumps described herein) can supplement the blood flow continuously or only during diastole. As shown in <FIG>, the blood pump <NUM> can receive an inlet blood flow FIN (e.g., via an inlet cannula, not shown) and produce an outlet blood flow FOUT. Because the blood pump <NUM> is suspended with the blood vessel V, the blood flow produced by the heart (e.g., during systole) can flow around the blood pump <NUM>, as shown by the arrow FBY.

When removal of the blood pump <NUM> is desired, the struts <NUM> can be detached from attachment portions <NUM> of the expandable member <NUM>, and the blood pump <NUM> and the struts <NUM> can be removed, as shown in <FIG>. This can be accomplished using any tools or by any of the methods described herein. In this manner, the only structure left in the blood vessel V is the expandable member <NUM>, which does not block the blood vessel V. By removing the struts <NUM> from the expandable member <NUM>, as opposed to removing the end portion of the struts <NUM> directly from the inner surface S of the blood vessel, the risk of perforation or tearing of the blood vessel V is minimized. Specifically, because implanted structure that is in direct contact with the inner surface S may be subject to tissue ingrowth, endothelialization, or the like, the arrangement of the assembly <NUM> provides a reliable way to remove the blood pump <NUM> via endovascular techniques and with minimal risk of damaging the blood vessel V.

Although the blood pump assembly <NUM> is shown as including one expandable member <NUM>, in other embodiments any of the blood pump assemblies described herein can include any number of expandable members that are removably coupled to a blood pump, a power supply or a set of struts. In this manner, the expandable assemblies can be positioned about the blood pump and/or power supply to produce the desired stability of the system (e.g., to minimize migration, tipping or the like). For example, <FIG> is a schematic illustration of a blood pump assembly <NUM>, according to an embodiment. Like the blood pump assemblies <NUM> and <NUM>, the blood pump assembly <NUM> can be transitioned between a first configuration (collapsed), a second configuration (expanded deployed) and a third configuration (pump retrieved). The blood pump assembly <NUM> includes a blood pump <NUM>, two sets of struts <NUM>, <NUM>', and two expandable members <NUM>, <NUM>'. The blood pump <NUM> can be any suitable device that pumps blood and provides the desired flow characteristics to supplement the output of the heart. For example, the blood pump <NUM> (and any of the blood pumps described herein) includes a pumping unit (not shown, e.g., an impeller, a roller, a balloon, or the like) enclosed within a housing <NUM>. An inflow cannula <NUM> is coupled to the distal end portion of the housing <NUM>, and the blood pump <NUM> produces an output flow in the direction indicated by the arrow AA in <FIG>. The blood pump <NUM> produces any suitable blood flow rate, for example a flow rate of between <NUM> liters per minute and <NUM> liters per minute. In some embodiments, the blood pump <NUM> (or any of the blood pumps described herein) can produce a flow rate of between <NUM> liters per minute and <NUM> liters per minute. Moreover, the blood pump <NUM> (and any of the blood pumps described herein) can be configured to limit the amount of heat transfer into the blood, reduce and/or eliminate points of stasis, or the like.

In some embodiments, the assembly <NUM> can include a power supply (not shown) that is also disposed within the housing <NUM>. In this manner, the assembly <NUM> (or any of the assemblies described herein) can include a power supply (battery, capacitance power supply, etc.) that can be disposed along with the blood pump <NUM> within the vasculature. In such embodiments, the assembly <NUM> (or any of the assemblies described herein) can also include a wireless charging system of the types shown and described herein (e.g., the wireless systems <NUM>, <NUM>).

The first expandable member <NUM> is coupled to the distal end portion of the housing <NUM>, and is configured to transition from a collapsed configuration to an expanded configuration. The first expandable member <NUM> includes a series of flexible segments <NUM> coupled together in any suitable pattern to form a tubular wall <NUM> having an outer surface <NUM> and an inner surface, and that defines an interior volume. The second expandable member <NUM>' is coupled to the proximal end portion of the housing <NUM>, and is configured to transition from a collapsed configuration to an expanded configuration. Like the first expandable member <NUM>, the second expandable member <NUM>' includes a series of flexible segments coupled together in any suitable pattern to form a tubular wall <NUM>' having an outer surface and an inner surface, and that defines an interior volume.

The expandable members <NUM>, <NUM>' can include any suitable number of flexible segments (e.g., the flexible segments <NUM>) in any suitable form, such as coiled members, longitudinal members, or the like. For example, in some embodiments, the flexible segments can be braided or woven to produce the tubular wall that can transition from the collapsed configuration to the expanded configuration. In some embodiments, the expandable member can include multiple layers of flexible segments to produce the desired spring characteristics and strength. In yet other embodiments, the flexible segments can be produced from a monolithic sheet of material (e.g., by a laser cutting process). Moreover, any the tubular walls <NUM>, <NUM>' (and any of the tubular walls described herein) can have any suitable pore size (or arrangement of openings) so that the outer surface provides the desired contact area within the bodily lumen, as described herein. In this manner, as described herein, the expandable members <NUM>, <NUM>' can be resistant to migration and can provide support for the blood pump <NUM> (and any power supply coupled within the housing <NUM>).

When in the expanded configuration, first expandable member <NUM> is spaced apart from the second expandable member <NUM>'. In this manner, the overall length of contact between the outer surfaces of the expandable members is greater than the sum of the contact length of each of the expandable members. As shown, the overall contact length (i.e., the length along the axial centerline CL from the distal-most portion of the first expandable member <NUM> to the proximal-most portion of the second expandable member <NUM>') is greater than the length of the pump <NUM> and/or the pump housing <NUM>. In this manner, the "two expandable member configuration" of the assembly <NUM> provides the desired anchoring and/or stability characteristics. For example, in some embodiments, a ratio between the overall contact length and the length of the blood pump <NUM> can be at least about <NUM>, <NUM>, <NUM>, <NUM> or <NUM>. The overall length can be limited by, for example, the flexibility to advance the blood pump assembly <NUM> within the vasculature of the patient (e.g., through the aortic arch) using endovascular techniques, as described herein. In other embodiments, the overall contact length can be less than the length of the blood pump <NUM>. For example, in some embodiments, a ratio between the overall contact length and the length of the blood pump <NUM> can be at least about <NUM>, <NUM>, or <NUM>.

When the blood pump assembly <NUM> is deployed within a blood vessel (not shown) and the expandable members <NUM>, <NUM>' are in their expanded configurations, the outer surfaces of the tubular walls <NUM>, <NUM>' can contact the inner surface of the blood vessel to maintain (or anchor) the expandable members <NUM>, <NUM>' within the blood vessel. By providing the anchoring force circumferentially and along the axial length of each expandable member <NUM>, <NUM>', as well as the overall contact length, the blood pump assembly <NUM> is resistant to migration (i.e., movement along the longitudinal center line CL) within the blood vessel. Similarly stated, the expandable members <NUM>, <NUM>' distribute the radially outward anchoring force over the contact area of the outer surfaces of each expandable member, thereby minimizing migration. This arrangement also minimizes and/or eliminates tipping (i.e., rotation about an axis non-parallel to the longitudinal center line CL). Moreover, by avoiding anchoring via discrete anchor points, the expandable member <NUM> and the blood pump assembly <NUM> reduces the likelihood of perforating the wall of the blood vessel.

The first expandable member <NUM> and the second expandable member <NUM>' each include a series of attachment portions <NUM>, <NUM>' to which a corresponding strut <NUM>, <NUM>' can be removably and/or releasably coupled. In some embodiments, the attachment portions <NUM>, <NUM>' (and any of the attachment portions described herein) can be a separate structure or mechanism that is coupled to the flexible segments or tubular wall <NUM>, <NUM>' of each expandable member. In other embodiments, the attachment portions <NUM>, <NUM>' (and any of the attachment portions described herein) can be monolithically constructed with (or a portion of) their respective flexible segments or tubular wall. Although the expandable members <NUM>, <NUM>' are shown as including two attachment portions <NUM>, <NUM>', in other embodiments, the expandable members <NUM>, <NUM>' (and any of the expandable members described herein) can include any suitable number of attachment portions (e.g., between two and eight, between two and ten, or between two and <NUM>). Although the attachment portions <NUM>, <NUM>' are shown as extending within the internal volume, in other embodiments, the attachment portions <NUM>, <NUM>' can be flush with the inner surface of the tubular walls <NUM>, <NUM>'. Similarly stated, in some embodiments, the tubular walls <NUM>, <NUM>' and the respective set of attachment portions <NUM>, <NUM>' define a continuous inner surface.

The blood pump assembly <NUM> includes two sets of struts <NUM>, <NUM>'. The first set of struts <NUM> correspond to the first expandable member <NUM> and the second set of struts <NUM>' correspond to the second expandable member <NUM>'. Each strut <NUM>, <NUM>' includes a first end portion and a second end portion. The first end portion of each strut <NUM>, <NUM>' is coupled to the pump <NUM> and/or the housing <NUM>. The first end portion can be coupled to the housing <NUM> in any suitable manner, such as a pin joint or a ball joint. In this manner, the struts <NUM>, <NUM>' can rotate or otherwise move relative to the housing (e.g., when the expandable members <NUM>, <NUM>' move from their collapsed configuration to their expanded configuration). In other embodiments, the first end portion of each strut can be coupled to the housing <NUM> by a band, weld joint, or adhesive. As shown, the struts <NUM>, <NUM>' are coupled to the housing <NUM> such that a longitudinal axis of the strut forms an acute strut angle θ with the axial centerline CL of the housing <NUM> (measured from the distal-most end of the axial centerline CL). Although the strut angle θ can change when the expandable members <NUM>, <NUM>' transition from their collapsed configuration to their expanded configuration, maintain the strut angle within a desired range can facilitate removal and/or collapsing of the struts during the removal process, as described herein. Although the strut angle θ is shown as being acute for both the first set of struts <NUM> and the second set of struts <NUM>', in other embodiments, the strut angle of the first set of struts <NUM> can be different than the strut angle of the second set of struts <NUM>'. For example, in some embodiments, the strut angle of the first set of struts <NUM> can be obtuse and the strut angle of the second set of struts <NUM>' can be acute. In other embodiments, the strut angle of the first set of struts <NUM> can be acute and the strut angle of the second set of struts <NUM>' can be obtuse. In yet other embodiments, the strut angle of the first set of struts <NUM> and the strut angle of the second set of struts <NUM>' can both be obtuse.

The second end portion of each strut <NUM>, <NUM>' is removably coupled to its corresponding attachment portion <NUM>, <NUM>'. In this manner, the blood pump <NUM> (and/or the power supply therein) can be removably coupled to the expandable members <NUM>, <NUM>' by the two sets of struts <NUM><NUM>'. Similarly stated, when the blood pump assembly <NUM> is in its first configuration and its second configuration, the blood pump <NUM> is suspended within the interior volume of the expandable members <NUM>, <NUM>' by the two sets of struts <NUM>, <NUM>'. Because the second end portion of each strut is removably (or releasably) coupled to the corresponding attachment portion, the blood pump <NUM> and the struts <NUM>, <NUM>' can be removed from the expandable members <NUM>, <NUM>' by any of the methods described herein.

In some embodiments, either of the attachment portions <NUM>, <NUM>' or the struts <NUM>, <NUM>' can include a latch, a locking mechanism, or detent that maintains the struts <NUM>, <NUM>' within the attachment portions <NUM>, <NUM>' until a retrieval force threshold has been exceeded. This arrangement prevents the struts <NUM>, <NUM>' from being inadvertently released or removed from the expandable member <NUM>, <NUM>'. Although the blood pump assembly <NUM> is shown as including two struts within each set of struts, in other embodiments, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) can include any suitable number of struts (e.g., between two and eight, between two and ten, or between two and <NUM>).

Although the housing <NUM> is described as including, in some embodiments, a close-coupled power supply, in other embodiments, a blood pump assembly can include a blood pump and a separately attached, but closely coupled power supply. In this manner, the power supply can be coupled along with the blood pump within the vasculature. This arrangement eliminates the need for passages, tubes, and/or wires to be extended outside of the body, and therefore this arrangement facilitates the long-term use of the pump assembly. Specifically, in some embodiments, a blood pump assembly includes a blood pump and power supply that are coupled by a flexible electrical lead that allows the pump and power supply to articulate relative to each other. In this manner, the assembly can be more easily advanced through tortuous passageways of the vasculature (e.g., the aortic arch). For example, <FIG> is a schematic illustration of a blood pump assembly <NUM>, according to an embodiment. Like the blood pump assemblies <NUM> and <NUM>, the blood pump assembly <NUM> can be transitioned between a first configuration (collapsed), a second configuration (expanded deployed) and a third configuration (pump retrieved). The blood pump assembly <NUM> includes a blood pump <NUM>, a power supply <NUM>, two sets of struts <NUM>, <NUM>', and two expandable members <NUM>, <NUM>'. The blood pump <NUM> can be any suitable device that pumps blood and provides the desired flow characteristics to supplement the output of the heart. For example, the blood pump <NUM> (and any of the blood pumps described herein) includes a pumping unit (not shown, e.g., an impeller, a roller, a balloon, or the like) enclosed within a housing <NUM>. An inflow cannula <NUM> is coupled to the distal end portion <NUM> of the housing <NUM>. The blood pump <NUM> produces any suitable blood flow rate, for example a flow rate of between <NUM> liters per minute and <NUM> liters per minute. In some embodiments, the blood pump <NUM> (or any of the blood pumps described herein) can produce a flow rate of between <NUM> liters per minute and <NUM> liters per minute. Moreover, the blood pump <NUM> (and any of the blood pumps described herein) can be configured to limit the amount of heat transfer into the blood, reduce and/or eliminate points of stasis, or the like.

As shown, the assembly <NUM> includes a power supply <NUM> that is coupled to the blood pump <NUM> by the electrical lead <NUM>. Specifically, the electrical lead <NUM> is coupled to the proximal end portion <NUM> of the housing <NUM> such that the blood pump <NUM> and the power supply <NUM> are axially aligned. Moreover, the electrical lead <NUM> is flexible such that the pump <NUM> and the power supply <NUM> can articulate relative to each other. In this manner, the assembly <NUM> can be more easily advanced through tortuous passageways of the vasculature (e.g., the aortic arch). The electrical lead <NUM> can have any suitable length such that the power supply <NUM> is closely-coupled to the blood pump <NUM>, while still maintaining the desired flexibility for implantation. For example, in some embodiments, the length of the electrical lead <NUM> is less than the length of the blood pump <NUM>. Specifically, in some embodiments, the length of the electrical lead <NUM> can be between about <NUM> and <NUM> of the length of the blood pump <NUM>. By maintaining a relatively short distance between the blood pump <NUM> and the power supply <NUM>, the assembly <NUM> can be implanted in the ascending aorta without the power supply obstructing the brachiocephalic artery, the left common carotid artery, or the left subclavian artery. In other embodiments, however, the length of the electrical lead <NUM> can be less than the length of the blood pump <NUM>.

The power supply <NUM> can include any suitable components of the types shown and described herein to provide power to the blood pump <NUM> within the vasculature. For example, the power supply <NUM> includes an energy storage member (not shown), such as a battery, a capacitance storage system, or the like. In some embodiments, the power supply <NUM> can also include a charging module that can be electromagnetically coupled to an external power supply (not shown). In this manner, the energy storage member (and the power supply <NUM>) can be recharged wirelessly, allowing for long term installation of the system. The charging module can include, for example, a receiving coil (not shown) configured to be electromagnetically coupled to an external power transmission coil (not shown). The charging module can be similar to any of the charging modules or systems shown and described herein (e.g., the wireless systems <NUM>, <NUM>).

The first expandable member <NUM> is coupled to the housing <NUM>, and is configured to transition from a collapsed configuration to an expanded configuration. The first expandable member <NUM> includes a series of flexible segments <NUM> coupled together in any suitable pattern to form a tubular wall <NUM> having an outer surface <NUM> and an inner surface, and that defines an interior volume. The second expandable member <NUM>' is coupled to the power supply <NUM>, and is configured to transition from a collapsed configuration to an expanded configuration. Like the first expandable member <NUM>, the second expandable member <NUM>' includes a series of flexible segments coupled together in any suitable pattern to form a tubular wall <NUM>' having an outer surface and an inner surface, and that defines an interior volume.

The expandable members <NUM>, <NUM>' can include any suitable number of flexible segments (e.g., the flexible segments <NUM>) in any suitable form, such as coiled members, longitudinal members, or the like. For example, in some embodiments, the flexible segments can be braided or woven to produce the tubular wall that can transition from the collapsed configuration to the expanded configuration. In some embodiments, the expandable member can include multiple layers of flexible segments to produce the desired spring characteristics and strength. In yet other embodiments, the flexible segments can be produced from a monolithic sheet of material (e.g., by a laser cutting process). Moreover, any the tubular walls <NUM>, <NUM>' (and any of the tubular walls described herein) can have any suitable pore size (or arrangement of openings) so that the outer surface provides the desired contact area within the bodily lumen, as described herein. In this manner, as described herein, the expandable members <NUM>, <NUM>' can be resistant to migration and can provide support for the blood pump <NUM> and the power supply <NUM>.

When in the expanded configuration, first expandable member <NUM> is spaced apart from the second expandable member <NUM>'. In this manner, the overall length of contact between the outer surfaces of the expandable members is greater than the sum of the contact length of each of the expandable members. As shown, the overall contact length (i.e., the length along the axial centerline CL from the distal-most portion of the first expandable member <NUM> to the proximal-most portion of the second expandable member <NUM>') is about the same as the length of the pump <NUM> and the power supply <NUM>. In other embodiments, however, a ratio between the overall contact length and the length of the collective length of the blood pump <NUM> and the power supply <NUM> can be at least about <NUM>, <NUM>, <NUM>, <NUM> or <NUM>. The overall length can be limited by, for example, the flexibility to advance the blood pump assembly <NUM> within the vasculature of the patient (e.g., through the aortic arch) using endovascular techniques, as described herein. In other embodiments, the overall contact length can be less than the collective length of the blood pump <NUM> and the power supply <NUM>. For example, in some embodiments, a ratio between the overall contact length and the collective length of the blood pump <NUM> and the power supply <NUM> can be at least about <NUM>, <NUM>, or <NUM>.

When the blood pump assembly <NUM> is deployed within a blood vessel (not shown) and the expandable members <NUM>, <NUM>' are in their expanded configurations, the outer surfaces of the tubular walls <NUM>, <NUM>' can contact the inner surface of the blood vessel to maintain (or anchor) the expandable members <NUM>, <NUM>' within the blood vessel. By providing the anchoring force circumferentially and along the axial length of each expandable member <NUM>, <NUM>', as well as the overall contact length, the blood pump assembly <NUM> is resistant to migration (i.e., movement along the longitudinal center line of the assembly) within the blood vessel. Similarly stated, the expandable members <NUM>, <NUM>' distribute the radially outward anchoring force over the contact area of the outer surfaces of each expandable member, thereby minimizing migration. This arrangement also minimizes and/or eliminates tipping (i.e., rotation about an axis non-parallel to the longitudinal center line CL). Moreover, by avoiding anchoring via discrete anchor points, the expandable member <NUM> and the blood pump assembly <NUM> reduces the likelihood of perforating the wall of the blood vessel.

The blood pump assembly <NUM> includes two sets of struts <NUM>, <NUM>'. The first set of struts <NUM> correspond to the first expandable member <NUM> and the second set of struts <NUM>' correspond to the second expandable member <NUM>'. Each strut <NUM>, <NUM>' includes a first end portion and a second end portion. The first end portion of each strut <NUM>, <NUM>' is coupled to the pump <NUM> and/or the housing <NUM>. The first end portion can be coupled to the housing <NUM> in any suitable manner, such as a pin joint or a ball joint. In this manner, the struts <NUM>, <NUM>' can rotate or otherwise move relative to the housing (e.g., when the expandable members <NUM>, <NUM>' move from their collapsed configuration to their expanded configuration). In other embodiments, the first end portion of each strut can be coupled to the housing <NUM> by a band, weld joint, or adhesive. The struts <NUM>, <NUM>' can be coupled to the housing <NUM> at any suitable strut angle θ with the axial centerline of the housing <NUM> or the power supply <NUM>.

The second end portion of each strut <NUM>, <NUM>' is removably coupled to its corresponding attachment portion <NUM>, <NUM>'. In this manner, the blood pump <NUM> and the power supply <NUM> can be removably coupled to the expandable members <NUM>, <NUM>' by the two sets of struts <NUM><NUM>'. Similarly stated, when the blood pump assembly <NUM> is in its first configuration and its second configuration, the blood pump <NUM> and the power supply <NUM> are suspended within the interior volume of the expandable members <NUM>, <NUM>' by the two sets of struts <NUM>, <NUM>'. Because the second end portion of each strut is removably (or releasably) coupled to the corresponding attachment portion, the blood pump <NUM>, the power supply <NUM>, and the struts <NUM>, <NUM>' can be removed from the expandable members <NUM>, <NUM>' by any of the methods described herein.

<FIG> are show a blood pump assembly <NUM>, according to an embodiment, that can be transitioned between a first configuration (collapsed), a second configuration (expanded and deployed) and a third configuration (pump retrieved). The blood pump assembly <NUM> is shown in the second configuration (<FIG>), and in various stages of being transitioned to the third configuration (<FIG>). The blood pump assembly <NUM> includes a blood pump <NUM>, a set of struts <NUM> (only one strut is labeled), and an expandable member <NUM>. The blood pump <NUM> can be any suitable device that pumps blood and provides the desired flow characteristics to supplement the output of the heart. For example, the blood pump <NUM> (and any of the blood pumps described herein) includes a pumping unit (not shown, e.g., an impeller, a roller, a balloon, or the like) enclosed within a housing <NUM>. The blood pump <NUM> produces any suitable blood flow rate, for example a flow rate of between <NUM> liters per minute and <NUM> liters per minute. In some embodiments, the blood pump <NUM> (or any of the blood pumps described herein) can produce a flow rate of between <NUM> liters per minute and <NUM> liters per minute. In some embodiments, the assembly <NUM> can include a power supply (not shown) that is close-coupled to the blood pump <NUM>, either within the housing <NUM> or within a separate housing (e.g., similar to the power supply <NUM> described above). Similarly stated, in some embodiments the assembly <NUM> (or any of the assemblies described herein) can include a power supply (battery, capacitance power supply, etc.) that can be disposed along with the blood pump <NUM> within the vasculature. In such embodiments, the assembly <NUM> (or any of the assemblies described herein) can also include a wireless charging system of the types shown and described herein (e.g., the wireless systems <NUM>, <NUM>).

The proximal end of housing <NUM> includes a proximal attachment portion <NUM> and an attachment band <NUM>. The proximal attachment portion <NUM> is used for retrieval of the pump, as described herein, and can include any mechanism for attaching the retrieval wire <NUM> to the pump <NUM> (see <FIG>). For example, in some embodiments, the proximal attachment portion <NUM> can include a hook, a threaded portion, a magnetic coupling mechanism, or the like. The distal end portion of the housing <NUM> is coupled to an inflow cannula <NUM>.

The expandable member <NUM> is configured to transition from a collapsed configuration (not shown) to an expanded configuration (<FIG>), and includes a series of flexible segments. The flexible segments include both longitudinal segments <NUM> and lateral segments <NUM> (see <FIG>), which can be coupled together in any suitable pattern to form a tubular wall <NUM>. The tubular wall <NUM> has an outer surface and an inner surface, and defines an interior volume, similar to that formed by the expandable members <NUM>, <NUM>, <NUM> described herein. The expandable member <NUM> can include any suitable number of flexible segments in any suitable form, such as coiled members, longitudinal members, or the like. For example, in some embodiments, the flexible segments (e.g., the lateral segments <NUM>) can be braided or woven to produce the tubular wall <NUM> that can transition from the collapsed configuration to the expanded configuration. In some embodiments, the expandable member <NUM> can include multiple layers of flexible segments to produce the desired spring characteristics and strength. In yet other embodiments, the flexible segments can be produced from a monolithic sheet of material (e.g., by a laser cutting process). Moreover, any the tubular wall <NUM> (and any of the tubular walls described herein) can have any suitable pore size (or arrangement of openings) so that the outer surface provides the desired contact area within the bodily lumen. In this manner, the expandable member can be resistant to migration and can provide support for the blood pump <NUM> suspended within the interior volume.

When the blood pump assembly <NUM> is deployed within a blood vessel (not shown) and the expandable member <NUM> is in its expanded configuration, the outer surface of the tubular wall <NUM> is in contact with an inner surface of the blood vessel. The expandable member <NUM> is sized and configured such that the outer surface exerts a radially outward force on the inner surface to maintain (or anchor) the expandable member <NUM> within the blood vessel. By providing the anchoring force circumferentially and along the axial length of the expandable member <NUM> (as opposed to multiple, discrete anchor points), the expandable member <NUM> and the blood pump assembly <NUM> are resistant to migration (i.e., movement along the longitudinal center line) within the blood vessel. This arrangement also minimizes and/or eliminates tipping (i.e., rotation about an axis non-parallel to the longitudinal center line). Moreover, by avoiding anchoring via discrete anchor points, the expandable member <NUM> and the blood pump assembly <NUM> reduces the likelihood of perforating the wall of the blood vessel.

The expandable member <NUM> includes a series of attachment portions <NUM> (only one is labeled) to which a corresponding strut <NUM> can be removably and/or releasably coupled. Although the attachment portions <NUM> are shown as being monolithically constructed along with the longitudinal segments <NUM>, in other embodiments, the attachment portions <NUM> (and any of the attachment portions described herein) can be a separate structure or mechanism that is coupled to the longitudinal segments <NUM> or tubular wall <NUM>. Moreover, because the attachment portions <NUM> are monolithically constructed as a part of the longitudinal segments <NUM>, the attachment portions <NUM> do not extend into or otherwise obstruct the interior volume of the expandable member. Similarly stated, the attachment portions <NUM> can be flush with (or form a continuous surface with) the inner surface <NUM> of the tubular wall <NUM>. In this manner, when the blood pump <NUM> is removed and the expandable member <NUM> is left within the body, the blood vessel will remain unobstructed. This arrangement also facilitates the implantation of a second blood pump assembly at the same location as (or on top of) the remaining expandable member. Although the expandable member <NUM> is shown as including six attachment portions <NUM>, in other embodiments, the expandable member <NUM> (and any of the expandable members described herein) can include any suitable number of attachment portions (e.g., between two and eight, between two and ten, or between two and <NUM>).

Referring to <FIG>, each attachment portion <NUM> defines a slot <NUM> within which the second end portion <NUM> of the corresponding strut <NUM> can be slidingly disposed. Moreover, each attachment portion <NUM> includes a shoulder <NUM> or "end stop" that resists movement of the second end portion <NUM> of the corresponding strut <NUM>. In this manner, when the assembly <NUM> is in the second (deployed) configuration, the second end portion <NUM> of each strut <NUM> is disposed within its corresponding slot <NUM>, and is in contact with the shoulder <NUM>. This arrangement prevents movement of the struts <NUM> in the direction indicated by the arrow BB in <FIG>. The direction BB is also the direction of blood flow, and thus, the force exerted by the flow of blood produced by the heart acts to maintain the second end portion <NUM> in contact with the shoulder <NUM>. Thus, when the assembly <NUM> is in the second (deployed) configuration, the second end portion <NUM> of each strut <NUM> is firmly and stably attached to the corresponding attachment portion <NUM>.

As described in more detail below, to remove the blood pump <NUM> and the struts <NUM>, a distal force (as indicated by the arrow CC) is applied to the struts <NUM>. When the distal retrieval force exceeds a threshold value, the second end portion <NUM> of the corresponding strut <NUM> can slide distally within the slot <NUM> to a position outside (and released from) the attachment portion <NUM>. In some embodiments, either of the attachment portions <NUM> or the second end portion <NUM> of the struts <NUM> can include a latch, a locking mechanism, or detent that maintains the struts <NUM> within their respective slots <NUM> until the retrieval force threshold has been exceeded. This arrangement prevents the struts <NUM> from being inadvertently released or removed from the expandable member <NUM>.

The blood pump assembly <NUM> includes a set of struts <NUM>. Each strut <NUM> includes a first end portion <NUM> and a second end portion <NUM>. The first end portion <NUM> of each strut <NUM> is coupled to the housing <NUM> by the attachment band <NUM>. In other embodiments, however, the first end portion <NUM> can be coupled by a pin joint or a ball joint, such that the strut <NUM> can rotate relative to the housing (e.g., when the expandable member <NUM> moves from its collapsed configuration to its expanded configuration). In other embodiments, the first end portion <NUM> can be coupled to the housing <NUM> by weld joint or adhesive.

As described above, the second end portion <NUM> of each strut is removably coupled within the slot <NUM> of its corresponding attachment portion <NUM> of the expandable member <NUM>. In this manner, the blood pump <NUM> can be removably coupled to the expandable member <NUM> by the set of struts <NUM>. More particularly, the blood pump <NUM> can be coupled to the expandable member <NUM> with at least a portion of the housing <NUM> disposed within the interior volume (not identified) of the expandable member <NUM>. In some embodiments, the second end portion <NUM> can include a hook, latch, or the like that engages the shoulder <NUM>. Similarly stated, in some embodiments, the second end portion <NUM> includes a protrusion having a longitudinal centerline that is offset from a centerline of the strut <NUM> (i.e., a curved or hooked portion). In some embodiments, the second end portion <NUM> of the struts <NUM> can include a latch, a locking mechanism, or detent that maintains the struts <NUM> within the slot <NUM> until a retrieval force threshold has been exceeded.

Because the second end portion <NUM> of each strut is removably (or releasably) coupled to the corresponding attachment portion <NUM>, the blood pump <NUM> and the struts <NUM> can be removed from the expandable member <NUM>. This arrangement allows the blood pump assembly <NUM> to be moved from the second configuration (<FIG>) to the third configuration (<FIG>). In this manner, the blood pump <NUM> and the struts <NUM> can be removed when the assembly <NUM> is within the body, for example, if the patient no longer needs the pump assembly <NUM>, if the blood pump <NUM> has malfunctioned, or the like. Moreover, the blood pump <NUM> and the struts <NUM> can be removed endoscopically by decoupling (or releasing) the struts <NUM> from the attachment portions <NUM>.

In use, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) can be implanted into a patient's circulatory system to supplement the blood flow output of the heart. Any suitable endovascular, minimally-invasive and/or percutaneous techniques can be used to implant the blood pump assembly <NUM>, according to any of the methods described herein. Moreover, because the blood pump <NUM> and the struts <NUM> can be removed from the expandable member <NUM>, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) is well suited for both short term and long term use. For example, the blood pump assembly <NUM> (and any of the blood pump assemblies described herein) can be implanted, and then removed within ten days, one month, two months, or less than one year when the patient no longer needs the circulatory assistance. As described herein, the blood pump <NUM> and the struts <NUM> can be removed (leaving the expandable member <NUM> behind) without obstructing the blood vessel. Similarly, when implanted for long-term use (e.g., one year, two years, or longer), the blood pump <NUM> and the struts <NUM> can be removed when there is a failure of the blood pump <NUM>, to replace the batteries (not shown) or the like.

To implant the blood pump assembly <NUM>, the assembly <NUM> is first inserted into an entry blood vessel (e.g., the femoral artery) endovascularly. Similarly stated, the assembly <NUM> is first inserted into an entry blood vessel (e.g., the femoral artery) using percutaneous and/or minimally invasive techniques. The blood pump assembly <NUM> is inserted when in its first (or collapsed) configuration. The blood pump assembly <NUM> is then advanced to a target blood vessel (not shown). The target blood vessel can be any suitable blood vessel, such as the descending aorta, the aortic arch, or the ascending aorta. The blood pump assembly <NUM> is then transitioned from its first (or collapsed) configuration to its second (or expanded configuration). When in the expanded configuration, the outer surface of the tubular wall <NUM> contacts, engages and/or exerts a radially outward force upon the inner surface of the blood vessel to anchor the blood pump assembly <NUM> within the blood vessel.

After being implanted, the blood pump <NUM> can be actuated (or powered) to supplement the blood flow provided by the patient's heart. In particular, the blood pump <NUM> (and any of the blood pumps described herein) can supplement the blood flow continuously or only during diastole. As shown in <FIG>, the blood pump <NUM> can receive an inlet blood flow via the inlet cannula <NUM> and produce an outlet blood flow. Because the blood pump <NUM> is suspended with the blood vessel, the blood flow produced by the heart (e.g., during systole) can flow around the blood pump <NUM>.

When removal of the blood pump <NUM> is desired, the struts <NUM> can be detached from attachment portions <NUM> of the expandable member <NUM>, and the blood pump <NUM> and the struts <NUM> can be removed. Referring to <FIG>, a retrieval tool <NUM> is advanced to the target blood vessel using endovascular techniques as described herein. The retrieval tool <NUM> includes a retrieval wire <NUM> and a retrieval sheath <NUM>. The retrieval wire is coupled to the proximal attachment portion <NUM>. As shown by the arrow EE in <FIG>, a proximal force can be exerted on the pump housing <NUM> to maintain the pump <NUM> within the blood vessel at a desired and/or constant position. The retrieval sheath <NUM> is advanced distally as shown by the arrow DD. An edge of the retrieval sheath <NUM> contacts the struts <NUM> as the sheath moves distally, thereby exerting a distal force upon the struts <NUM>. When the distal force is sufficient to overcome the retrieval force threshold (e.g., the resistance of the blood flow, the resistance of the detent, etc.), each of the struts <NUM> moves distally within the slots <NUM>, as shown by the arrow FF in <FIG>. Continued movement of the sheath <NUM> releases the struts <NUM> from their respective attachment portions <NUM>, and allows the blood pump <NUM> and the struts <NUM> to be enclosed within the sheath <NUM> for withdrawal from the body.

Removal in this manner leaves only the expandable member <NUM> with the blood vessel, which does not block the blood vessel. The design of the expandable member <NUM> can facilitate installation of a second (e.g., a replacement) pump assembly directly on top of the existing expandable member. Moreover, by removing the struts <NUM> from the expandable member <NUM>, as opposed to removing the end portion of the struts <NUM> directly from the inner surface of the blood vessel, the risk of perforation or tearing of the blood vessel is minimized. Specifically, because implanted structure that is in direct contact with the inner surface may be subject to tissue ingrowth, endothelialization, or the like, the arrangement of the assembly <NUM> provides a reliable way to remove the blood pump <NUM> via endovascular techniques and with minimal risk of damaging the blood vessel.

Although the attachment portions <NUM> are shown and described above as defining the slots <NUM> within which the second end portion <NUM> of the respective strut <NUM> is disposed, in other embodiments, the struts can define the slots within which a protrusion of the attachment portions are slidingly disposed. Moreover, any suitable detent or resistance mechanism can be included. For example, <FIG> shows an attachment portion <NUM>' that defines a slot <NUM>' within which a strut <NUM>' can be disposed. The attachment portion <NUM>' includes protrusions <NUM>' that resist the distal movement of the strut <NUM>' until a retrieval force threshold has been exceed.

<FIG> shows an attachment portion configured to enable a "twist-lock" type retrieval mechanism. In particular, <FIG> shows an attachment portion <NUM>" that defines a slot <NUM>" within which a strut <NUM>'' can be disposed. The slot <NUM>" is bounded by a proximal shoulder <NUM>'' that prevents proximal movement of the strut <NUM>'' and a twist-lock shoulder <NUM>'' that limits (but does not prevent) distal movement of the strut <NUM>" during retrieval. To remove the strut <NUM>" the strut <NUM>'' must be rotated as indicated by the arrow GG before it can be moved distally within the slot (arrow HH).

Although the blood pump assembly <NUM> is shown as including one set of struts <NUM> that is coupled to the proximal end portion of the housing <NUM>, in other embodiments, a blood pump assembly can include any number of struts that are coupled to the pump and/or the power supply in any suitable axial locations. For example, in some embodiments, a blood pump assembly can include multiple sets of struts that couple to the housing, the blood pump and/or the power supply at multiple different axial locations. In this manner, the assembly can reduce the likelihood of tipping and increase the stability of the blood pump within the vasculature. For example, <FIG> shows a blood pump assembly <NUM>, according to an embodiment, that can be transitioned between a first configuration (collapsed), a second configuration (expanded and deployed) and a third configuration (pump retrieved). The blood pump assembly <NUM> includes a blood pump <NUM>, a first set of struts <NUM> (only one strut is labeled), a second set of struts <NUM>' (only one strut is labeled), and an expandable member <NUM>. The blood pump <NUM> is similar to the blood pump <NUM> (and any other blood pump described herein), and is therefore not described in detail. The expandable member <NUM> is similar to the expandable member <NUM> in many respects, and is not described in detail. The expandable member <NUM> differs from the expandable member <NUM>, however, in that the expandable member <NUM> includes multiple sets of attachment portions (not identified), each corresponding to a strut within the different sets of struts <NUM>, <NUM>'. The attachment portions can be similar to the attachment portions <NUM> described above. The first set of struts <NUM> is coupled to the proximal end portion of the blood pump <NUM>, and the second set of struts <NUM>' is coupled to the central portion of the blood pump <NUM>. In this manner, the two sets of struts <NUM>, <NUM>' provide resistance against tipping.

In some embodiments, any of the blood pump assemblies shown and described herein can be implanted to any suitable target blood vessel endovascularly. <FIG> is a flow chart of a method <NUM> of implantation of a blood pump assembly, according to an embodiment not according to the invention, present for illustration purposes only. The method <NUM> is also illustrated in <FIG>, which show a schematic illustration of the method of implantation with the heart <NUM>. The method <NUM> can performed using any of the blood pump assemblies described herein. Although the schematic illustrations in <FIG> show a blood pump <NUM> (having an inflow cannula <NUM>) and an expandable member <NUM>, the method can be performed using any of the blood pump assemblies described herein.

The method <NUM> includes inserting into an entry blood vessel a blood pump assembly, at <NUM>. The blood pump assembly includes a blood pump (see e.g., blood pump <NUM>), an expandable member (see e.g., expandable member <NUM>), and a set of struts (not shown in <FIG>). The expandable member includes a set of flexible segments that form a tubular wall defining an interior volume, similar to any of the expandable members described herein. The expandable member includes a set of attachment portions. A first end portion of each strut is coupled to the blood pump, and a second end portion of each strut is removably coupled to a corresponding attachment portion such that at least a portion of the blood pump is within the interior volume of the expandable member. As shown in <FIG>, the inserting performed when the expandable member is in a collapsed configuration.

In some embodiments, the inserting optionally includes percutaneously inserting a catheter (see e.g., the catheter assembly <NUM> including the sheath <NUM>) that contains the blood pump assembly into the entry blood vessel. In some embodiments, the method includes inserting the blood pump assembly percutaneously into a femoral artery.

Although <FIG> show the implantation of a blood pump <NUM>, in some embodiments, the method <NUM> includes inserting a blood pump assembly that includes a power supply coupled to the blood pump and configured to provide power to drive the blood pump. For example, in some embodiments, the method includes inserting a blood pump assembly that includes an integrated power supply (e.g., the assembly <NUM>). In other embodiments, the method includes inserting a blood pump assembly that includes a close-coupled power supply (e.g., the assembly <NUM>).

The blood pump assembly is then advanced through the entry blood vessel and to a target blood vessel, at <NUM>. As shown by the arrow II in <FIG>, in some embodiments, the catheter assembly <NUM> can be advanced in a retrograde manner within the descending aorta, through the aortic arch and into the ascending aorta. Thus, in some embodiments, the target blood vessel is the ascending aorta, and the advancing can be performed until the inflow cannula (see cannula <NUM> in <FIG>) is advanced through the aortic valve and into the left ventricle.

The expandable member is then transitioned from the collapsed configuration to an expanded configuration such that the flexible segments contact an inner surface of the target blood vessel (e.g., the ascending aorta), at <NUM>. In this manner, the blood pump is suspended within the target blood vessel by the struts. The transitioning can be performed by any suitable method. For example, in some embodiments, the sheath <NUM> can be moved proximally, as shown by the arrow JJ in <FIG> to allow the expandable member to be moved outside of the sheath. In some embodiments, the tubular wall of the expandable member is constructed from a shape memory material such that the expandable member assumes its expanded configuration after being removed from the sheath <NUM>. In other embodiments, the catheter assembly <NUM> can include a balloon that is disposed at least partially within the interior volume of the expandable member. In such embodiments, the balloon can be inflated to exert a radially outward force on the tubular wall to urge the transition from the collapsed configuration to the expanded configuration.

As described herein, the blood pump and the struts are configured to be removed from the target blood vessel by removing the second end portion of each strut from the corresponding attachment portion. Thus, in some embodiments, the method <NUM> optionally includes removing the second end portion of each strut from the corresponding attachment portion from the plurality of attachment portions when the expandable member is in its expanded configuration within the target blood vessel, at <NUM>. The struts can be removed by any of the methods (or mechanisms) shown and described herein. For example, in some embodiments, the struts can be similar to the struts <NUM> and can be removed by the methods shown and described above with reference to the blood pump assembly <NUM>. In some embodiments, the method <NUM> optionally retrieving the blood pump and the plurality of struts from the target blood vessel, at <NUM>.

In some embodiments, any of the blood pump assemblies shown and described herein can be retrieved from any of the target blood vessels endovascularly. <FIG> is a flow chart of a method <NUM> of retrieving a blood pump assembly, according to an embodiment not according to the invention, present for illustration purposes only. The method <NUM> can performed using any of the blood pump assemblies described herein. For example, in some embodiments, the method of retrieval can be performed on the blood pump assembly <NUM> (and using the retrieval tool <NUM>) shown and described in <FIG>.

The method <NUM> includes inserting into an entry blood vessel a retrieval sheath, at <NUM>. The entry blood vessel can be, for example, a femoral artery. In other embodiments, however, the entry blood vessel can be any suitable vessel. Moreover, in some embodiments, the inserting can be performed percutaneously.

The retrieval sheath is then advanced through the entry blood vessel and to a target blood vessel, at <NUM>. The target blood vessel can be, for example, the ascending aorta. In other embodiments, however, the target blood vessel can be the descending aorta or any other vessel within the body.

The retrieval sheath is positioned about a proximal end portion of a blood pump from a blood pump assembly, at <NUM>. Referring to <FIG>, the blood pump assembly includes the blood pump, an expandable member, and a set of struts. The expandable member including a tubular wall in contact an inner surface of the target blood vessel and defining an interior volume. The expandable member includes a set of attachment portions. A first end portion of each strut is coupled to the blood pump, and a second end portion of each strut is coupled to a corresponding attachment portion such that at least a portion of the blood pump is within the interior volume of the expandable member and suspended within the target blood vessel.

An end portion of the retrieval sheath is moved distally relative to the blood pump. This operation is performed to A) remove the second end portion of each strut from the corresponding attachment portion and B) place the blood pump and the plurality of struts within the retrieval sheath. In some embodiments, movement of the end portion of the retrieval sheath distally relative to the blood pump causes removal of the second end portion of each strut from within a slot defined by the corresponding attachment portion. In some embodiments, movement of the end portion of the retrieval sheath distally relative to the blood pump includes rotating the blood pump and struts relative to the expandable member to "unlock" the struts from the corresponding attachment portion. In some embodiments, movement of the end portion of the retrieval sheath distally relative to the blood pump is accompanied by application of a proximal force to the blood pump to maintain the blood pump relative to the expandable member.

The retrieval sheath, including the blood pump and the plurality of struts, is then retracted from the target blood vessel, at <NUM>.

As described above, in some embodiments, any of the blood pump assemblies can include a self-contained and/or close coupled power supply. In this manner, the assembly can include a power supply (battery, capacitance power supply, etc.) that can be disposed along with the blood pump within the vasculature. The power supply (e.g., the power supply <NUM>) can include any suitable battery of different sizes, made from different material or cell packs. The battery can also be configured to be charged or discharged at slow or fast rate. In some embodiments, the internal power supply includes a re-chargeable battery or an ultra-capacitor. The power supply powers the electronics involved, pump, and other control circuitry for programming of the pump.

In some embodiments, any of the power supplies described herein can include and/or be coupled to a control system at the implant site or outside can perform power management and adjust for sleep mode, idle mode, activation and improved operational mode based on the history of use of the assembly.

In some embodiments, any of the assemblies described herein can also include an external power source, control system and/or wireless charging system. For example, the external power source (not shown) can be situated in proximity of the subject with implanted blood pump assembly containing the internal power supply. The external power source can be portable and can be placed near the patient within which the blood pump assembly is implanted. In some embodiments, any of the systems described herein can include a wireless power transmission system. The wireless power transmission system may be implemented using any suitable system architecture and resonator design. In some embodiments, the external power supply can charge the internal power supply wirelessly and by means of magnetic resonance as well. For example, <FIG> are schematic illustrations of applicable inductance and resonance technology that can be used with any of the systems described herein. Specifically, these figures show a portion of an internal power supply <NUM> and an external power / charging system <NUM>. Collectively, these systems include a pair of coils that include a receiving coil <NUM> and a transmitting coil <NUM>. The electromagnetic induction method operates based on the electromagnetic force that arises between coils in the presence of a magnetic flux. As shown in <FIG>, the magnetic field passes between the receiving coil <NUM> and the transmitting coil <NUM>. As will be appreciated by those skilled in the art, the receiving coil and transmitting coil can be off axis, as shown. As shown in <FIG>, power passes from the transmitting coil <NUM> to the receiving coil <NUM>. In some embodiments, the internal power supply can include a rectifier with a DC converter.

<FIG> is a block diagram of a wireless charging system <NUM> suitable to power any of the blood pump assemblies described herein. A rectifier IC <NUM> has a communication module and a controller <NUM> in communication with a rectifier <NUM> and a voltage conditioner <NUM>. The rectifier IC <NUM> is in communication with a transmitter IC <NUM> that has a power drive <NUM> and a DC input <NUM>. Power is transmitted from the transmitter IC <NUM> to the rectifier IC <NUM>. The system can be equipped with a charging system that employs magnetic resonance (resonant inductive coupling). The near field method transmits power wirelessly over a space utilizing resonance phenomena and the transmitter coil and receiver coil oscillates (or resonates) at the same frequency which is determine by the material and shape of the coil. In one configuration, the system uses magnetic induction and n another configuration magnetic resonance.

As will be appreciated by those skilled in the art, the system can operate under relevant standards, e.g. Alliance for Wireless Power (A4WP) for implementation in MI (Q!, WPC, etc.). Energy from the on-board coil is transferred to a capacitor, for example, which is transferred to an energy storage system such as a battery, and then to the implanted vascular pump. The configuration of the system allows for wireless charging. The system described capable of charging multiple implantable devices which have been deployed within the body (e.g., pace maker, pump, defibrillator, etc.). The controller is configured to monitor a fuel gauge or available energy level of the battery by communicating with the implanted system. Based on information provided to the controller, the implanted power supply can begin charging or charge on demand. The controller can be set by the user or the operator to charge on set schedules or based on energy storage level of the implanted power supply.

<FIG> is a block diagram that illustrates additional details of the wireless charging system <NUM>. The external system <NUM> provides for an improved configuration for wireless power transfer for biological applications by use of magnetic resonance, as described herein. In some embodiments, the external system can transmit sufficient power to charge a battery (e.g., the battery contained within the internal power supply, of the types described herein). The magnetic resonance charging can be activated by a user from outside of the body, by a power supply or implanted device signaling the power supply to get activated when the low energy storage level is sensed. To re-charge the power supply for the pump once the pump has been implanted, a wireless charger is brought into proximity to the exterior of the chest wall of a patient. As will be appreciated by those skilled in the art, magnetic resonance charging (or wireless charging) uses an electromagnetic field to transfer energy between two objects as shown in <FIG>. Energy is conveyed through magnetic resonance coupling to an electrical device, which then uses that energy to charge the device battery.

Although the blood pump assemblies have been shown and described here as including an implanted (also referred to as internal) power supply that is coupled within the target blood vessel, in other embodiments, any of the pump assemblies (and methods) described herein can include an implanted blood pump that is coupled to a power supply implanted within the body, but outside of the heart or the target blood vessel. For example, in some embodiments, the blood pump assembly <NUM> or <NUM> (or any other blood pump assemblies described herein) can include a blood pump coupled within the ascending aorta that is electrically coupled to a power supply that is implanted within the body, but outside of the heart, the aorta, or the like. For example, in some embodiments, a blood pump assembly can include a power supply that is superficially mounted (e.g., in a subclavicular region) of the body. In such embodiments, an electrical lead can be routed within the body to couple the blood pump and the power supply.

In some embodiments, such blood pump assemblies can include an electrical lead that is advanced transseptally through the right portion of the heart and into the left ventricle, where it is then coupled to a blood pump implanted within the ascending aorta. The blood pump can be implanted within the ascending aorta in accordance with any of the methods and systems described herein.

In some embodiments not according to the invention, present for illustration purposes only, a method includes routing an electrical lead from a power supply and transseptally into the left side of the heart. For example, <FIG> is a schematic illustration of and <FIG> is a flow chart illustrating a method <NUM> of coupling an electrical lead between an implanted extracardiac power supply and an intracardiac pump assembly, according to an embodiment not according to the invention, present for illustration purposes only. The method <NUM> can performed using any of the blood pump assemblies described herein. Although the schematic illustration in <FIG> shows a blood pump <NUM> having an electrical lead <NUM> that is retrieved using a snare <NUM>, the method can be performed using any of the blood pump assemblies described herein.

The method <NUM> includes inserting into an entry blood vessel a blood pump assembly, at <NUM>. The blood pump assembly including a blood pump, an inflow cannula, and an electrical lead. The blood pump assembly is then advanced through the entry blood vessel and to an ascending aorta, at <NUM>. The blood pump assembly is affixed within the ascending aorta such that the inflow cannula is disposed through an aortic valve and within a left ventricle, at <NUM>. The implanting and affixing of the blood pump assembly can be performed according to any of the methods described herein. For example, in some embodiments, the method <NUM> includes implanting and affixing a blood pump assembly that includes an expandable member (not shown in <FIG>).

A snare is then advanced through a superior vena cava and transseptally into the left ventricle, at <NUM>. This is shown in <FIG> by the snare <NUM>, which advances transseptally as shown by the arrow at the end of the snare. A proximal end portion of the electrical lead is then captured using the snare, at <NUM>. As shown in <FIG>, a distal end portion of the lead is configured to be coupled to the blood pump. The proximal end portion of the electrical lead is then advanced through the superior vena cava, at <NUM>. The method further includes attaching the proximal end portion of the electrical lead to a power supply located in a subcutaneous region of a body, at <NUM>.

Although the method <NUM> is shown as implanting the pump assembly with the electrical lead attached thereto, and then routing the lead back to the power supply, in other embodiments, the pump assembly can be implanted without the electrical lead, and the lead can be routed transseptally into the left ventricle and then coupled to the pump assembly. For example, <FIG> are schematic illustrations of and <FIG> is a flow chart illustrating a method <NUM> of coupling an electrical lead between an implanted extracardiac power supply and an intracardiac pump assembly, according to an embodiment not according to the invention, present for illustration purposes only. The method <NUM> can performed using any of the blood pump assemblies described herein. Although the schematic illustration in <FIG> shows a blood pump <NUM>' having an electrical lead <NUM>' that is manipulated and attached using a snare <NUM>', the method can be performed using any of the blood pump assemblies described herein.

The method <NUM> includes inserting into an entry blood vessel a blood pump assembly, at <NUM>. The blood pump assembly including a blood pump and an inflow cannula. The blood pump assembly is then advanced through the entry blood vessel and to an ascending aorta, at <NUM>. The blood pump assembly is affixed within the ascending aorta such that the inflow cannula is disposed through an aortic valve and within a left ventricle, at <NUM>. The implanting and affixing of the blood pump assembly can be performed according to any of the methods described herein. For example, in some embodiments, the method <NUM> includes implanting and affixing a blood pump assembly that includes an expandable member (not shown in <FIG>).

A distal end portion of an electrical lead through a superior vena cava and transseptally into the left ventricle snare is then advanced through a superior vena cava and transseptally into the left ventricle, at <NUM>. The distal end portion of the electrical lead is then coupled to the blood pump, at <NUM>. The proximal end portion of the electrical lead is configured to be coupled to a power supply located in a subcutaneous region of a body.

While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods described above indicate certain events occurring in certain order, the ordering of certain events may be modified. Additionally, certain of the events may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above.

For example, in some embodiments, any of the expandable members shown and described herein can include a marker portion (e.g., a marker band) configured to allow the practitioner to visualize the position of the expandable member within the blood vessel. Similarly, in some embodiments, any of the blood pumps, inflow cannulas, and electrical leads described herein can include a marker portion. In the manner, the practitioner can visualize the position of the components of the blood pump assembly to ensure the appropriate placement within the body. The marker portions can include any a radiopaque material, such as platinum.

Although shown and described as including a set of flexible segments, in other embodiments, the expandable member <NUM> (and any of the expandable members shown and described herein) can be monolithically constructed from a material sheet that is fabricated to include a series of pores, and that can transition from the collapsed configuration to the expanded configuration. For example, in some embodiments, any of the expandable members described herein can be a laser-cut expandable member.

For example, any of the expandable members described herein can be constructed from any suitable material or combination of different materials disclosed herein. Moreover, in some embodiments, at least a portion of any of the expandable members described herein (e.g., the expandable members <NUM>, <NUM>, <NUM>, <NUM> and <NUM>) can be coated. Such coatings can include, for example, a drug coating.

Any of the blood pump assemblies described herein can include one or more sensors to measure the cardiac output and activity level of the patient. Such sensors can include, for example, a flow sensor, an accelerometer, or the like. Moreover, any of the blood pump assemblies described herein can include a control system configured to receive one or more signals from the sensor(s) and adjust the output of the blood pump based on such signals.

In some embodiments, any of the blood pump assemblies described herein include a close-coupled (or internally mounted) power supply that can be recharged and/or powered by any suitable wireless method, such as, for example, by inductive coupling, capacitive coupling, or the like. Moreover, although the system <NUM> described above is shown as including one external transmission portion that is coupled to one internal power supply (e.g., within or closely-coupled to the blood pump), in other embodiments, any of the blood pump assemblies or systems described herein can include any number of intermediate structures to facilitate the desired power transfer. For example, in some embodiments, any of the blood pump assemblies described herein can include an external power supply, an internal receiving member (e.g., a pad, harvesting device, or the like) that is subcutaneously mounted, and an internal power supply (e.g., that is within or closely-coupled to the blood pump). In such embodiments, the internal receiving member can be mounted in the subclavicular region, and can be coupled to the power supply of a blood pump mounted within the ascending aorta via an electrical lead. In some embodiments, the electrical lead can be routed to the power supply of the blood pump transseptally according to the method <NUM> or the method <NUM> described herein.

Although the blood pump assemblies described herein include a close-coupled (or internally mounted) power supply that can be charged via inductive coupling and a magnetic field, in some embodiments, any of the assemblies described herein can be charged and/or powered via radiofrequency (RF) charging, with the ability to harvest energy by receiving via antenna on the device.

Although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination of any features and/or components from any of embodiments where appropriate. For example, any of the expandable members shown and described herein can be constructed from any of the materials described herein with respect to any other expandable member. Specifically, any of the expandable members described herein can be constructed from any suitable material that provides the desired strength, spring characteristics and biocompatibility. For example, in some embodiments, any of the expandable members described herein can be constructed from a metal, such as, for example, a medical grade stainless steel, a cobalt-based alloy, platinum, gold, titanium, tantalum, and/or niobium. In some embodiments, any of the expandable members described herein can be constructed from a shape memory material, such as a nickel-titanium alloy (e.g., Nitinol®). In other embodiments, any of the expandable members described herein) can be constructed from a polymeric material, such as, for example, poly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), poly(glycolide) (PGA), poly(L-lactide-co-D,L-lactide) (PLLA/PLA), polyethylene terephthalate (PET), poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,L-lactide-co-glycolide) (PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC), polydioxanone (PDS), Polycaprolactone (PCL), polyhydroxybutyrate (PHBT), poly(phosphazene)poly(D,L-lactide-co-caprolactone) PLA/PCL), poly(glycolide-co-caprolactone) (PGA/PCL), poly(phosphate ester), or the like.

Claim 1:
An apparatus, comprising:
an expandable member (<NUM>,<NUM>,<NUM>,<NUM>,<NUM>) configured to transition from a collapsed configuration to an expanded configuration, the expandable member including a plurality of flexible segments (<NUM>,<NUM>,<NUM>) that form a tubular wall defining an interior volume, the plurality of flexible segments configured to contact an inner surface of a blood vessel when the expandable member is in the expanded position, the expandable member including a plurality of attachment portions (<NUM>,<NUM>,<NUM>,<NUM>);
a blood pump (<NUM>,<NUM>,<NUM>,<NUM>,<NUM>,<NUM>) including a housing (<NUM>,<NUM>,<NUM>,<NUM>); and
a plurality of struts (<NUM>,<NUM>,<NUM>,<NUM>,<NUM>) each having a first end portion coupled to the housing, each strut from the plurality of struts having a second end portion configured to be removably coupled to a corresponding attachment portion from the plurality of attachment portions, such that the blood pump is configured to be removably coupled to the expandable member with at least a portion of the housing disposed within the interior volume of the expandable member,
characterized in that,
the second end portion of a strut from the plurality of struts is configured to be slidingly disposed within a slot defined by an attachment portion from the plurality of attachment portions.