Pump for endovascular use and related methods

Abstract

A pump is provided for endovascular use. In one embodiment, the pump includes an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation. The inner tubular housing has a sidewall with one or more openings for transmitting fluid flow in a radial direction relative to the axis of rotation. A controller may control operation of a motor for causing rotation of the agitator, and a sensor may be provided for supplying input to the controller for controlling the motor, such as based on a condition of the body.

Description

Docket No.: P-29904.W001DW 021944-00975PUMP FOR ENDOVASCULAR USE AND RELATED METHODSBACKGROUND

[0001] Chronic venous insufficiency, or CVI, is a condition commonly caused by the malfunctioning of incompetent valves in the veins. These incompetent valves make it difficult for the veins to deliver blood effectively from the legs to the heart. For example, in a normally functioning vein, one-way valves open when blood is pushed forward toward the heart, and then close in order to keep the blood moving in the right direction. When these valves do not function properly and fail to close, blood may flow backward in the vein. As a result, blood pools in the legs, and CVI occurs. The main causes for incompetent valves are vein dilation due to elevated pressures, which prevents normal leaflet coaptation, and deep vein thrombosis (DVT), which directly damages the valves.

[0002] The current treatment for incompetent valves in deep veins involves compression stockings but in more severe cases may involve invasive surgery. This is not only costly and complicated, but requires a long recovery time, often leading to negative outcomes, and is thus a generally undesirable option. Despite numerous attempts to develop artificial vein valves, currently none provides a workable solution that adequately restores competency to damaged veins. Even if able to restore proper venous flow under certain conditions, the use of artificial valves also presents additional challenges, such as thrombus formation in a stagnant flow environment, which may have deleterious consequences.

[0003] Accordingly, a need exists for an apparatus for endovascular use that addresses or overcomes these limitations. The apparatus would be deployable within deep veins and would be capable of reliable and repeatable positioning in a vein in order to achieve optimal flow and hemodynamics, as well as to protect it against impact and migration. The apparatus would also be adapted to provide flow assistance when mostDocket No.: P-29904.W001 DW 021944-00975 needed, such as when the patient is inactive, but not when such assistance is unnecessary, such as when the patient is active or in a supine position. Such control would enhance efficiency and result in a longer battery life, which life could be further enhanced by passively powering the apparatus. Overall, the apparatus would be useful to address the issue of CVI in a previously unknown manner without involved, invasive surgical procedures, and thus enhance efficiency in terms of the delivery of medical treatment, providing a significant overall benefit to societal good in terms of health outcomes.SUMMARY

[0004] An object of the disclosure is to provide a pump for endovascular use that addresses or overcomes the problems associated with incompetent veins, resulting in CVI and negative health outcomes. The pump would be deployable within deep veins using endovascular placement, and thus potentially avoid the need for invasive surgery. An external cage configuration allows for reliable and repeatable positioning of the pump in a vein, as well as to protect it against external compression and migration. A housing for an agitator for causing fluid flow provides for flow in a radial direction to achieve optimal flow and hemodynamics. Control involving a variety of sensor technologies allows the pump to provide flow assistance when most needed, such as when the patient is inactive, but not when such assistance is unnecessary, such as when the patient is active or in a supine position. Powering of the pump passively using arterial pressure reduces or eliminates reliance on an external power source. Such an external power source may additionally or alternatively power the pump, such as in an inductive manner. Overall, the pump addresses the issue of CVI without involved, invasive surgical procedures, and thus enhance efficiency in terms of the delivery of medical treatment, providing a significant overall benefit to societal good in terms of health outcomes.Docket No.: P-29904.W001 DW 021944-00975

[0005] According to a first aspect of this disclosure, an apparatus for use in a blood vessel in a body. The apparatus comprises a pump adapted for positioning within the blood vessel. The pump includes an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation. The inner tubular housing comprises a sidewall having one or more openings for transmitting fluid flow in a radial direction relative to the axis of rotation.

[0006] In one embodiment, a motor is connected to the housing for rotating the agitator. The pump may further include a retrieval hook connected to the housing or the motor. A controller may also be provided, which is adapted to control the motor, such as depending on a condition, such as orientation, of the body.

[0007] The pump may further include a sensor for providing input to the controller. The sensor may be selected from the group consisting of a gyrometer, a pressure sensor, a flow sensor, a current sensor, a timer, and combinations thereof. In one embodiment, the sensor comprises the pressure sensor or the flow sensor, and the controller is adapted to control the rotation speed of the motor based on a sensed amount of pressure or flow in the blood vessel. In this or another embodiment, the sensor is a timer for communicating with the controller to control the motor based on a time value indicative of the orientation of the body.

[0008] The pump may be adapted to be powered at least partially from a power source external to the body. Alternatively or additionally, the pump may be adapted to be powered at least in part by physical motion of the body. For example, the pump may be located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery including the fluid flow, connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery including the fluid flow, and / or connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery. In any case, the pump may be located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.Docket No.: P-29904.W001 DW 021944-00975

[0009] In these or other embodiments, the agitator comprises an impeller including a plurality of vanes connected to a tubular piece of material. The external cage may comprise a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the vessel. The apparatus may further include a remote control for regulating the operation of the pump. The external cage may comprise a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.

[0010] According to a further aspect of the disclosure, an apparatus for use in a blood vessel in a body is provided. The apparatus comprises a pump adapted for positioning within the blood vessel. The pump includes an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor. A controller is provided for controlling operation of the motor, and a sensor for providing input to the controller for controlling the motor based on a state of the body.

[0011] In one example, the sensor may be selected from the group consisting of a gyrometer, a pressure sensor, a flow sensor, a current sensor, a timer, and combinations thereof. In one embodiment, the sensor comprises the pressure sensor or the flow sensor, and the controller is adapted to control the rotation speed of the motor based on a sensed amount of pressure or flow in the blood vessel. In this or another embodiment, the sensor comprises the timer for communicating with the controller to control the motor based on a time value indicative of the orientation of the body.

[0012] The pump may be adapted to be powered at least partially from a power source external to the body. Alternatively or additionally, the pump may be adapted to be powered at least in part by physical motion of the body. The pump may be located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery, connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery, and / or connected wirelessly to receive electrical energy caused by rotation of an impeller locatedDocket No.: P-29904.W001 DW 021944-00975 in an artery. In any case, the pump may be located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.

[0013] In these or other embodiments, the agitator comprises an impeller including a plurality of vanes connected to a tubular piece of material. The external cage may comprise a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the vessel. The apparatus may further include a remote control for regulating the operation of the pump. The external cage may comprise a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.

[0014] According to yet another aspect of the disclosure, an apparatus for use in a blood vessel in a body is provided. The apparatus comprises a pump adapted for positioning within the blood vessel. The pump includes an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor. A controller is provided for controlling operation of the motor, and a generator is adapted to generate power for the operation of the motor based on physical motion of the body.

[0015] In one embodiment, the pump is located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery. In another embodiment, the pump is located in the blood vessel in the form of a vein, and connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery. In still a further embodiment, the pump is located in the blood vessel in the form of a vein, and connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery. In any case, the pump may be located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner. Alternatively or additionally, the generator comprises a piezoelectric generator. The apparatus may further include a remote control for regulating the operation of the pump. The external cage may comprise a first portion forDocket No.: P-29904.W001DW 021944-00975 enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.

[0016] Still a further aspect of the disclosure pertains to an apparatus for use in a blood vessel in a body. The apparatus comprises a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor. A controller is provided for controlling operation of the motor to cause intermittent flow of blood in the blood vessel. A sensor may also be provided for sensing for sensing pressure or flow in the blood vessel, and the controller is adapted to control the motor based on a sensed amount of pressure or flow in the blood vessel.

[0017] Related methods of using any disclosed apparatus for regulating blood flow in a vein are also described as part of this disclosure.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] The above and further advantages of the disclosure may be better understood by referring to the following description in conjunction with the accompanying drawings in which:

[0019] FIG. 1 is a side view of an endovascular pump according to one aspect of the disclosure.

[0020] FIG. 1A is a cross-sectional view taken along line 1A-1A of FIG. 1.

[0021] FIG. 2 is a side view of another embodiment of an endovascular pump according to the disclosure.

[0022] FIG. 3 is a perspective view of an external cage for the endovascular pump.

[0023] FIG. 3A is a cross-sectional view taken along line 3A-3A of FIG. 3.

[0024] FIG. 4 is a side schematic view of another embodiment of an endovascular pump.

[0025] FIG. 5 is control diagram for an endovascular pump

[0026] FIGS. 6, 7, and 8 are schematic views showing various forms of generators for generating power for an endovascular pump in situ.Docket No.: P-29904.W001 DW 021944-00975

[0027] FIG. 9 is a side view of another embodiment of an endovascular pump according to the disclosure.

[0028] FIGS. 10 and 11 are illustrations of a human body including an endovascular pump in a standing and supine position.

[0029] FIGS. 12 and 13 are illustrations of an endovascular pump installed in a vein associated with the calf muscle in a relaxed and contracted state, respectively.

[0030] FIGS. 14, 15, and 16 illustrate the formation of an impeller for use in the endovascular pump.

[0031] The dimensions of some of the elements in the drawings may be exaggerated relative to other elements for clarity or several physical components may be included in one or element. Further, sometimes reference numerals may be repeated among the drawings to indicate corresponding or analogous elements. Moreover, some of the items depicted in the drawings may be combined into a single function.DETAILED DESCRIPTION

[0032] In the following detailed description, numerous specific details are set forth to provide a thorough understanding of the disclosure in relation to various inventions. The disclosed embodiments may be practiced without these specific details. In other instances, well-known methods, procedures, components, or structures may not have been described in detail so as not to obscure the present invention.

[0033] The principles and operation of the apparatus and methods of the disclosure may be better understood with reference to the drawings and accompanying descriptions. The invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention is capable of other embodiments or of being practiced or carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purpose of description and should not be regarded as limiting.Docket No.: P-29904.W001 DW 021944-00975

[0034] Certain features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention that are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. The description provided below and in regard to the figures applies to all embodiments unless noted otherwise, and features common to each embodiment are similarly shown and numbered to the greatest extent possible to lend clarity, but should not be considered limiting in any respect.

[0035] Referring now to FIGS. 1 and 2, provided is a pump 10 adapted for endovascular use and, in particular, for placement in situ in a vein in which one or more valves have become incompetent to render flow assistance on a continuous or intermittent basis, and thereby essentially replace the resulting missing functionality. In the illustrated embodiment, the pump 10 includes an external cage 12 and an inner housing 14 connected thereto. The inner housing 14 at least partially encloses an agitator in the form of an impeller 16 rotatable about an axis of rotation X for pumping fluid along a vessel when the pump 10 is in situ. A motor 18 is also provided for rotating the impeller 16, which may be connected to the housing 14.

[0036] The housing 14 for enclosing the impeller 16 includes a sidewall having at least one opening 14a formed therein. This lateral opening 14a is in fluid communication with a tubular portion of the housing 14 in which the impeller 16 is located, and also with an open end 14b of the housing 14, as can be understood from the cross-sectional view of FIG. 1A. Thus, when the impeller 16 is oriented in a suitable manner and rotated as a result of a connection with the motor 18 (such as by way of a drive shaft 20 and suitable gearing, if desired), fluid (e.g., blood in the case of a blood vessel) is caused to flow from external to the housing 14, radially into the lateral opening 14a, and exit through the open end 14b, as indicated by action arrows F in FIG. 1. The pressure head generated by operation of the impeller 16 may vary depending on the application, and in one example would be approximately the pressure difference between two sets of valves in a veinDocket No.: P-29904.W001 DW 021944-00975 associated with the lower leg to ensure the desired outflow of blood results in a natural manner.

[0037] Turning to FIG. 3, an example of the external cage 12 is shown. The cage 12 in this example includes a plurality of struts 12a, such as four. The struts 12a may be generally symmetrical about a central axis coincident with the axis of rotation of the impeller when located therein. The ends of the struts 12a may be connected to tubular collars 12b, which may be sized and shaped to receive and engage the housing 14, as shown in FIGS. 1 and 2, thus forming a releasable but secure connection between the two structures.

[0038] The struts 12a and collars 12b may be fabricated using a variety of methods. For instance, these structures may be formed by cutting a tube of material, leaving the continuous ends to form the collars 12b. Then, the process involves moving the collars 12b toward each other to expand the struts 12a, thus forming the cage 12.

[0039] In such an arrangement, it can be appreciated that the outer surface of each strut 12a is generally planar, but slightly arcuate in cross-section taken in a transverse direction, as a result of being cut from a tube, as perhaps best understood from the cross-sectional view of FIG. 3A. This arrangement advantageously increases the surface area of each strut 12a that may make intimate contact with the similarly curved inner wall of the vessel in which the pump 10 is positioned, and thus further helps to prevent migration upon implantation in the endovascular space. As can be appreciated, the cage 12 also protects the housing 14 and impeller 16 therein from external interference or compression, which could interfere with the operation if not kept in check.

[0040] The cage 12 may take alternative forms besides that shown in FIG. 1. For example, in FIG. 4, the cage 12 comprises a network of crossing struts 12a. These struts 12a form a reticulated structure for capturing and containing the motor 18 and associated impeller 16 providing the pumping action for moving fluid through the vessel in which the pump 10 is positioned, and also help to prevent pump migration. The particularDocket No.: P-29904.W001 DW 021944-00975 arrangement of the struts 12a forming the cage 12 is not considered important, as long as fluid flow is not significantly impeded in a manner that would impact the ability of the pump 10 to provide the desired flow assistance via pumping action.

[0041] Delivery of the pump 10 to a location within a blood vessel may be achieved using an endovascular procedure. For instance, the pump 10 may be attached to a suitable catheter (not shown) and introduced into the vasculature for advancement to the desired location in a vein for providing flow assistance. To facilitate delivery, the struts 12a forming the cage 12 may be made of a flexible, resilient material, such as a polymer or metal, which allows the cage 12 to assume a collapsed configuration for delivery, and then expand once in situ (such as upon exiting a delivery sheath). In one particular version, the struts 12a are formed of a shape memory material, such as Nitinol, and thus may be expanded to the configuration for engaging the vessel as a result of a change of state, such as temperature. Implantation of the pump 10 may also be done via surgical procedure, but this may be less desirable in some situations versus endovascular delivery in view of the additional complexity that may result and potential for complications during any invasive surgical procedure.

[0042] Turning back to FIGS. 1 and 2, retrieval of the pump 10 may be facilitated by the presence of one or more retrieval hooks 17. These hook(s) 17 may be connected to the housing 14 or the motor 18, and as shown may be provided on either end of the pump 10 or elsewhere. A snare (not shown) may then be used to engage the hook(s) 17 and retrieve or reposition the pump 10 within the blood vessel.

[0043] Turning to FIG. 5, the motor 18 may be associated with a controller 22 for controlling its operation. The controller 22 thus regulates rotation of the impeller 16 and hence the pumping action provided (which may be on, off, or at a variety of speeds, and continuous or intermitted / impeded). The controller 22 may include a suitable driver 24 for driving the motor 18, which may comprise a three phase, brushless DC motor, for example. ioDocket No.: P-29904.W001 DW 021944-00975

[0044] The driver 24 may be associated with control logic 26 for controlling the operation of the motor 18. This control logic 26 may receive input from a sensor 28 for determining the conditions for controlling the operation of the motor 18 to maximize pumping efficiency and ensure operation in the optimal manner, as outlined further in the following description. The controller 22 may be integral with the pump 10, such as by being positioned on or within the housing 14, or as outlined further below, may be at a remote location for transmitting control signals via wired or wireless connection to a receiver associated with the pump 10.

[0045] Power for the motor 18 and controller 22 may be provided via an associated generator, which may comprise charge circuit 30, and may further include an onboard battery. In the illustrated example, the charge circuit 30 is adapted for inductive charging. In particular, the charge circuit 30 includes an input coil 32. An output coil 34 may be positioned in proximity to the input coil 32, but located outside of the body (note boundary B). In this manner, the pump 10 may be powered or charged from a location external to the body. Alternatively, power for the pump 10 may de generated or provided by an onboard non-rechargeable battery (e,g., Lithium Carbon Monofluoride), and the pump simply removed at the end of its service life.

[0046] Alternative or additional forms of generators for powering or charging the pump 10 may be utilized. For example, as shown in FIG. 6, the pump 10 when positioned in a first vessel, such as a vein V, may be energized by a mechanical connection to an impeller 36 placed in a second vessel, such as an artery A, which is caused to rotate as a result of fluid flow F therein. The connection may be established by a flexible transluminal drive shaft 38, which serves to transmit rotary motion from the impeller 36 generated by fluid pressure to the impeller 16 associated with the pump.

[0047] Another version is shown in FIG. 7. In this version, a motor 40 associated with an impeller 42 and an outer cage 44 is located in a first vessel, such as an artery A, to the pump 10 located in a second vessel, such as vein V. A conduit, such as wire 38,Docket No.: P-29904.W001 DW 021944-00975 transmits electrical energy generated from the back electromotive force of the motor 40 serves to provide energy for powering the pump 10.

[0048] Yet another version is shown in FIG. 8. In this version, the arrangement is similar to that of FIG. 7 , except instead of a wired connection, energy transfer is achieved wirelessly using near field resonant inductive coupling. Specifically, energy harvested from rotation of the impeller 42 is converted to electrical energy at high efficiency within a wire coil 46, and transferred via inductive coupling I to a wire coil 48 associated with the pump 10.

[0049] Still another alternative for a generator is to use a piezoelectric generator (not shown) for generating energy to power the pump 10. The piezoelectric generator may generate electrical energy for powering the pump 10 based on the motion of the body in which the pump 10 is implanted.

[0050] As noted above, the pump 10 may also be operated or controlled remotely, such as by the patient, clinician, or other relevant person rendering assistance. For example, as shown in FIG. 5, a remote control 47 external to the body (note line B) may communicate control signals to the control logic 26 of the pump 10. The communication may be achieved by transmitting the control signals via radiofrequency energy from a transmitter or otherwise wirelessly, which signals are received by the control logic 26, such as by way of an associated wireless receiver 49, and processed to regulate operation of the pump 10, and agitator 16 in particular. This may allow forthe on / off state, schedule of operation (such as by regulating the timer operation), speed, motor response to sensor output, or any other feature of the pump 10 to be controlled remotely.

[0051] As noted previously, control of the pump 10 may be reliant on the output of a sensor 28 associated therewith. For example, the sensor 28 may be one or more of a pressure sensor (such as a strain gauge located over a recess with known pressure in the side of the housing, such as at location Li in FIG. 4), a flow sensor (e.g., a piezoelectric flow sensor, which may be positioned at location L2 to detect flow at the housing 14), a motor current sensor (located on motor PCB), which can be used to measure the backDocket No.: P-29904.W001 DW 021944-00975 pressure of the pump (as the motor 18 will draw more current (input power) if it has to produce more output power (torque) to overcome the pressure at a particular set-point speed), or other forms of sensors (including a timer, as noted in the following description). In the case of a sensor 28 used for sensing pressure or flow, the result may be closed loop speed control of the motor 18 and thus the impeller 16, such as based on sensed hydrostatic pressure or flow rate sensing. In such case, as pressure or flow increases, rotational speed of the motor 18 may increase.

[0052] The control logic 26 may also be adapted to regulate the operation of the motor 18 to cause substantially intermittent flow, as would be the case if the venous valves were functioning normally. For example, the on / off state of the motor 18 may be regulated based on the sensor 28 sensing increased pressure or flow in the vessel, thus signaling a need for pumping assistance. When decreased pressure or flow is sensed, the motor 18 may be disabled or caused to idle, so that it does not meaningfully contribute to enhancing blood flow in the vessel.

[0053] An alternate embodiment of the pump 10 is shown in FIG. 9. In this version, the cage 12 comprises a plurality of portions, such as a forward portion 13 and a rearward portion 15. These portions 13, 15 may be separate from each other and connected to the housing 14 at corresponding end portions thereof, but could also form part of a single structure. Aside from engaging the vessel wall when expanded, as shown, the forward portion 13, as shown, surrounds the impeller 16, and thus protects it from external interference. The rearward portion when expanded provides a centering function to help ensure the axis of rotation is substantially aligned and generally parallel with the longitudinal axis of the vessel including the pump 10. When expanded, these portions 13, 15 may provide the pump 10 with a dog-bone or barbell shape when viewed from the side, with flared end portions and a lower profile central portion.

[0054] The sensor 28 may also comprise a gyrometer, which may be associated with the housing, such as at location L2 in FIG. 4. The gyrometer may be used to detect when the subject is in a vertical positon, as shown by body B in FIG. 10, versus a horizontalDocket No.: P-29904.W001 DW 021944-00975 position, as shown by body B' in FIG. 11, with the pump 10 shown being located in the upper leg or thigh region. In the horizontal position, the need for active pumping of blood may be eliminated, and so output from the gyrometer serving as sensor 28 may be used to turn off the pump 10, or else simply regulate it to operate at a lower idle speed to conserve energy. When the gyrometer as sensor 28 detects a change in position requiring flow assistance, such as to the vertical or standing position, the pump 10 may be activated or caused to operate at an increased speed to provide the desired flow assistance as needed to overcome the resulting effects of gravity.

[0055] The sensor 28 may also be one adapted to sense time or the passage of time and implement control of the motor 18 as a result. For example, the sensor 28 via the controller 22 could cause the motor 18 to turn off or run idle at times when the body is likely to be at rest and flow assistance is not required, such as during nighttime hours. The controller 22 based on the sensor 28 output could then activate or regulate the speed during times when the body is likely to be more active, when flow assistance is needed.

[0056] The detection of flow using the sensor 28 (pressure or flow) may also be used to regulate the operation of the pump 10. As an example when the pump 10 is used in the lower leg, and with reference to FIGS. 11 and 12, the calf muscles M when relaxed do not cause blood flow though an associated vein V, and thus operation of the pump 10 is not required. Hence, the pump 10 may be off, or operated at an idle speed, so that meaningful flow assistance is not provided.

[0057] When the calf muscles then contract, as indicated by M', such as during walking, running, pressing a pedal, or the like, blood is caused to flow through the associated vein V as a result of the contraction. The sensor 28 associated with the pump 10 may detect this increase in fluid flow or pressure, and activate the pump 10 to provide the desired assist function. Consequently, the pump 10 in terms of enhancing flow basically functions in a similar manner to the valves in the vein, if competent, by effectively creating a one-way valve.Docket No.: P-29904.W001 DW 021944-00975

[0058] The impeller 16 used may be of any form as desired to achieve the desired fluid flow in an efficient and effective matter. With reference to FIGS. 13, 14 and 15, one particular manner of forming an impeller 16 for use in connection with the pump 10 is illustrated. Slots 50 may be formed in a piece of tubular material 52, as shown in FIG. 13. The slots 50 may be elongated, and may be linear or non-linear (including possibly spiral or zig-zag). While shown as having a constant width, the width of the slots 50 may also be variable.

[0059] When the opposed ends of the tubular material 52 are moved inwardly towards each other, the remaining piece of material 54 between the slots 50 is caused to bow outwardly and thus form a vane 56, as shown in FIGS. 14 and 15. By forming pairs of slots 50 sequentially around the tubular material 52, a plurality of vanes 56 may be formed in this manner, thus forming the impeller 16.

[0060] Summarizing, this disclosure may relate to any of the following items in any combination:1. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation, the inner tubular housing comprising a sidewall having one or more openings for transmitting fluid flow in a radial direction relative to the axis of rotation.2. The apparatus of item 1, further including a motor connected to the housing for rotating the agitator.3. The apparatus of item 1 or item 2, further including a retrieval hook connected to the housing or the motor.4. The apparatus of any of items 1-3, further including a controller adapted to control the motor depending on an orientation of the body.Docket No.: P-29904.W001 DW 021944-009755. The apparatus of item 4, further including a sensor for providing input to the controller, the sensor being selected from the group consisting of a gyrometer, a pressure sensor, a flow sensor, a current sensor and a timer.6. The apparatus of item 5, wherein the sensor comprises the pressure sensor or the flow sensor, and the controller is adapted to control the rotation speed of the motor based on a sensed amount of pressure or flow in the blood vessel.7. The apparatus of item 5, wherein the sensor is the timer for communicating with the controller to control the motor based on a time value indicative of a state or orientation of the body.8. The apparatus of any of items 1-7, wherein the pump is adapted to be powered at least partially from a power source external to the body.9. The apparatus of item 8, wherein the pump is adapted to be powered at least in part by physical motion of the body.10. The apparatus of item 9, wherein the pump is located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery including the fluid flow.11. The apparatus of item 9, wherein the pump is located in the blood vessel in the form of a vein, and connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery including the fluid flow.12. The apparatus of item 9, wherein the pump is located in the blood vessel in the form of a vein, and connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery.13. The apparatus of any of items 1-12, wherein the pump is located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.14. The apparatus of any of items 1-13, wherein the agitator comprises an impeller including a plurality of vanes connected to a tubular piece of material.Docket No.: P-29904.W001 DW 021944-0097515. The apparatus of any of items 1-14, wherein the external cage comprises a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the vessel.16. The apparatus of any of items 1-15, further including a remote control for regulating the operation of the pump.17. The apparatus of any of items 1-16, wherein the external cage comprises a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.18. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor; a controller for controlling operation of the motor; and a sensor for providing input to the controller for controlling the motor based on a state of the body.19. The apparatus of item 18, wherein the sensor is selected from the group consisting of a gyrometer, a pressure sensor, a flow sensor, a current sensor and a timer.20. The apparatus of item 18 or item 19, wherein the sensor comprises the pressure sensor or the flow sensor, and the controller is adapted to control the rotation speed of the motor based on a sensed amount of pressure or flow in the blood vessel.21. The apparatus of item 18, wherein the sensor comprises the timer for communicating with the controller to control the motor based on a time value indicative of a state or the orientation of the body.22. The apparatus of any of items 18-21, wherein the pump is adapted to be powered at least partially from a power source external to the body.23. The apparatus of item 18, wherein the pump is adapted to be powered at least in part by physical motion of the body.Docket No.: P-29904.W001 DW 021944-0097524. The apparatus of item 23, wherein the pump is located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery.25. The apparatus of item 23, wherein the pump is located in the blood vessel in the form of a vein, and connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery.26. The apparatus of item 23, wherein the pump is located in the blood vessel in the form of a vein, and connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery. 1. The apparatus of any of items 1-26, wherein the pump is located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.28. The apparatus of any of items 18-27, wherein the agitator comprises an impeller including a plurality of vanes connected to a tubular piece of material.29. The apparatus of any of items 18-28, wherein the external cage comprises a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the vessel.30. The apparatus of item 18, further including a remote control for regulating the operation of the pump.31. The apparatus of item 18, wherein the external cage comprises a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.32. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor; a controller for controlling operation of the motor; and a generator adapted to generate power for the operation of the motor based on physical motion of the body.Docket No.: P-29904.W001 DW 021944-0097533. The apparatus of item 32, wherein the pump is located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery.34. The apparatus of item 32, wherein the pump is located in the blood vessel in the form of a vein, and connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery.35. The apparatus of item 32, wherein the pump is located in the blood vessel in the form of a vein, and connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery.36. The apparatus of any of items 32-35, wherein the pump is located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.37. The apparatus of item 32 or item 36, wherein the generator comprises a piezoelectric generator.38. The apparatus of any of items 18-37, wherein the external cage comprises a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the blood vessel.39. The apparatus of any of items 18-38, further including a remote control for regulating the operation of the pump.40. The apparatus of any of items 18-39, wherein the external cage comprises a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.41. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor; and a controller for controlling operation of the motor to cause intermittent flow of blood in the blood vessel.Docket No.: P-29904.W001 DW 021944-0097542. The apparatus of item 41, further including a sensor for sensing for sensing pressure or flow in the blood vessel, and the controller is adapted to control the motor based on a sensed amount of pressure or flow in the blood vessel.43. A method of regulating blood flow in a vein using the apparatus of any of items 1-42.

[0061] As used herein, the following terms have the following meanings: "A", "an", and "the" as used herein refers to both singular and plural referents unless the context clearly dictates otherwise. By way of example, "a compartment" refers to one or more than one compartment. "About," "substantially," or "approximately," as used herein referring to a measurable value, such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of + / - 20% or less, including + / - 10% or less, + / -5% or less, + / -1% or less, and + / -0.1% or less of and from the specified value, in so far such variations are appropriate to perform in the disclosed invention. However, it is to be understood that the value to which such modifiers refer is itself also specifically disclosed. Comprise", "comprising", and "comprises" and "comprised of" as used herein are synonymous with "include", "including", "includes" or "contain", "containing", "contains" and are inclusive or open-ended terms that specifies the presence of what follows e.g. component and do not exclude or preclude the presence of additional, non-recited components, features, element, members, steps, known in the art or disclosed therein.

[0062] Although the invention has been described in conjunction with specific embodiments, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it embraces all such alternatives, modifications, and variations that fall within the spirit and scope of the appended claims. All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, identification of anyDocket No.: P-29904.W001DW 021944-00975 reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure.

Claims

Docket No.: P-29904.W001DW 021944-00924IN THE CLAIMS1. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation, the inner tubular housing comprising a sidewall having one or more openings for transmitting fluid flow in a radial direction relative to the axis of rotation.

2. The apparatus of claim 1, further including a motor connected to the housing for rotating the agitator.

3. The apparatus of claim 2, further including a retrieval hook connected to the housing or the motor.

4. The apparatus of claim 2, further including a controller adapted to control the motor depending on a state of the body.

5. The apparatus of claim 3, further including a sensor for providing input to the controller, the sensor being selected from the group consisting of a gyrometer, a pressure sensor, a flow sensor, a current sensor, or a timer.

6. The apparatus of claim 5, wherein the sensor comprises the pressure sensor or the flow sensor, and the controller is adapted to control the rotation speed of the motor based on a sensed amount of pressure or flow in the blood vessel.

7. The apparatus of claim 5, wherein the sensor comprises the timer for communicating with the controller to control the motor based on a time value indicative of the state of the body.Docket No.: P-29904.W001DW 021944-009248. The apparatus of claim 1, wherein the pump is adapted to be powered at least partially from a power source external to the body.

9. The apparatus of claim 1, wherein the pump is adapted to be powered at least in part by physical motion of the body.

10. The apparatus of claim 9, wherein the pump is located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery including the fluid flow.

11. The apparatus of claim 9, wherein the pump is located in the blood vessel in the form of a vein, and connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery including the fluid flow.

12. The apparatus of claim 9, wherein the pump is located in the blood vessel in the form of a vein, and connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery.

13. The apparatus of claim 1, wherein the pump is located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.

14. The apparatus of claim 1, wherein the agitator comprises an impeller including a plurality of vanes connected to a tubular piece of material.

15. The apparatus of claim 1, wherein the external cage comprises a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the vessel.Docket No.: P-29904.W001DW 021944-0092416. The apparatus of claim 1, further including a remote control for regulating the operation of the pump.

17. The apparatus of claim 1, wherein the cage comprises a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.

18. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor; a controller for controlling operation of the motor; and a sensorfor providing input to the controllerfor controllingthe motor based on a state of the body.

19. The apparatus of claim 18, wherein the sensor is selected from the group consisting of a gyrometer, a pressure sensor, a flow sensor, a current sensor, and a timer.

20. The apparatus of claim 18, wherein the sensor comprises the pressure sensor or the flow sensor, and the controller is adapted to control the rotation speed of the motor based on a sensed amount of pressure or flow in the blood vessel.

21. The apparatus of claim 18, wherein the sensor comprises the timer for communicating with the controller to control the motor based on a time value indicative of the state of the body.

22. The apparatus of claim 18, wherein the pump is adapted to be powered at least partially from a power source external to the body.Docket No.: P-29904.W001DW 021944-0092423. The apparatus of claim 18, wherein the pump is adapted to be powered at least in part by physical motion of the body.

24. The apparatus of claim 23, wherein the pump is located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery.

25. The apparatus of claim 23, wherein the pump is located in the blood vessel in the form of a vein, and connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery.

26. The apparatus of claim 23, wherein the pump is located in the blood vessel in the form of a vein, and connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery.

1. The apparatus of claim 18, wherein the pump is located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.

28. The apparatus of claim 18, wherein the agitator comprises an impeller including a plurality of vanes connected to a tubular piece of material.

29. The apparatus of claim 18, wherein the external cage comprises a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the vessel.

30. The apparatus of claim 18, further including a remote control for regulating the operation of the pump.Docket No.: P-29904.W001DW 021944-0092431. The apparatus of claim 18, wherein the external cage comprises a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.

32. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor; a controller for controlling operation of the motor; and a generator adapted to generate power for operating of the motor based on physical motion of the body.

33. The apparatus of claim 32, wherein the pump is located in the blood vessel in the form of a vein, and mechanically connected to receive rotational energy caused by rotation of an impeller located in an artery.

34. The apparatus of claim 32, wherein the pump is located in the blood vessel in the form of a vein, and connected by a wire to receive electrical energy caused by rotation of an impeller located in an artery.

35. The apparatus of claim 32, wherein the pump is located in the blood vessel in the form of a vein, and connected wirelessly to receive electrical energy caused by rotation of an impeller located in an artery.

36. The apparatus of claim 32, wherein the pump is located in the blood vessel in the form of a vein, and is adapted to operate in an intermittent manner.

37. The apparatus of claim 32, wherein the generator comprises a piezoelectric generator.Docket No.: P-29904.W001DW 021944-0092438. The apparatus of claim 32, wherein the external cage comprises a plurality of struts elongated in a direction of the axis of rotation and having a generally planar outer surface for engaging the blood vessel.

39. The apparatus of claim 32, further including a remote control for regulating the operation of the pump.

40. The apparatus of claim 32, wherein the external cage comprises a first portion for enclosing the agitator and a second portion separate therefrom for orienting the housing in the blood vessel.

41. An apparatus for use in a blood vessel in a body, comprising: a pump adapted for positioning within the blood vessel, the pump including an external cage adapted for engaging the blood vessel and an internal tubular housing for an agitator rotatable about an axis of rotation by an associated motor; and a controller for controlling operation of the motor to cause intermittent flow of blood in the blood vessel.

42. The apparatus of claim 41, further including a sensor for sensing for sensing pressure or flow in the blood vessel, and the controller is adapted to control the motor based on a sensed amount of pressure or flow in the blood vessel.

43. A method of regulating blood flow in a vein using the apparatus of any of claims 1-42.

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