Patent Application
20180303992
In certain disease states, the heart lacks sufficient pumping capacity to meet the needs of the body. This inadequacy can be alleviated by providing a mechanical pumping device referred to as a blood pump, one example of which is a ventricular assist device (“VAD”). A VAD, for example, acts in parallel with a patient's left ventricle to impel blood from the ventricle into the aorta, and thus supplements the pumping action of the heart.
A blood pump is typically connected, e.g., installed, outside of the heart. In the instance of a VAD, it may include an inlet cannula connecting the interior of the left ventricle to the intake of the pump. The VAD may also include an outlet tube connected between the outlet of the pump and the aorta. Once connected to a ventricle, the VAD and the heart act in parallel to pump blood from the left ventricle to the aorta. A blood pump in a typical human patient should be capable of providing substantial blood flow, as, for example, a few liters per minute or more, against a pressure head corresponding to the blood pressure of the patient. For example, one typical operating condition for a blood pump involves pumping 5 liters of blood flow at a pressure head of 75 mmHg. Pressure head is known as the difference in pressure between the outlet and the inlet of the pump, where a positive number indicates higher pressure at the outlet.
Implantable blood pumps should also be compact so as to facilitate mounting the pump within the patient's body. An implantable blood pump should further be efficient so as to minimize the power required to operate the pump, for example, by reducing the rotational speed needed to achieve a particular pressure head. Moreover, the pump should be designed to minimize damage to the patient's blood. It should limit the amount of blood subjected to relatively high shear stresses, for example, 150 Pa or more, so as to minimize the damage to components of the blood. Ideally, and in addition to these attributes, a blood pump should remain in operation for months or years to keep a patient alive, or indefinitely at least until the heart heals or a suitable donor heart becomes available if the heart does not heal.
One form of a blood pump is disclosed in U.S. Pat. No. 8,852,072. The pump includes a pump housing having an impeller and a diffuser disposed within the pump housing. The impeller has a linear body extending along an axis and blades projecting outwardly from the body and curving around the axis in a substantially helical pattern having a pitch angle which varies along the axial length of the impeller. A power source provides the means to actuate the impeller, causing it to impel blood axially in the housing in a downstream direction towards a linear diffuser. The diffuser includes vanes projecting radially outward from the body. The pump generates pressure head for blood entering through an inlet of the housing and exiting into the aortic valve. Although prior art pumps can generate pressure to pump blood, further improvements as described above would be desirable.
Accordingly, there is a need for an implantable blood pump which is sized so that a diffuser region of a housing having a diffuser disposed therein does not extend into an aortic valve when implanted in a ventricle. There is also a need for a pump which produces greater pressure head through the pump relative to prior art designs while simultaneously reducing shear stresses within the housing.
The present invention relates to blood pumps containing a diffuser and methods of manufacturing and using the blood pumps.
One aspect of the present invention provides an implantable blood pump. The pump includes a housing having an intake end and an outflow end, a cannulated tip extending from the outflow end of the housing, an impeller disposed in the housing, and a diffuser disposed in the housing. The diffuser includes a tapered body.
In one embodiment according to this aspect of the invention, the housing can have a first portion adjacent the intake end, a second portion adjacent the outflow end, and a third portion between the first and second portions. A cross-sectional area of the first portion can be greater than a cross-sectional area of the second portion. A cross-sectional area of the third portion can decrease in a direction from the first portion to the second portion. The housing can also be linear.
The diffuser can be disposed in the third portion of the housing. The first, second and third portions can be sized such that when the implantable blood pump is positioned within a left ventricle, only the second portion and the cannulated tip interact with an aortic valve. The cross sectional area of the first, second and third portions can be circular.
An inner surface of the third portion of the housing can taper toward the outflow end in parallel with a surface of the tapered body of the diffuser. This parallel taper can be such that the cross-sectional area of a flow path between the inner surface of the third portion and the diffuser is approximately the same at any point along a length of the tapered body of the diffuser.
In another embodiment, the tapered body of the diffuser can be a truncated cone shape. A cross-sectional area of the tapered body can be largest at an intake end of the tapered body.
A length of the diffuser can be between about 0.50 inches and less than 0.85 inches. The length of the diffuser can also be preferably about 0.55 inches. The diffuser can include a first conically shaped tip extending from the diffuser body towards the outflow end and a second conically shaped tip extending from the diffuser body towards an intake end. The volume of the tips is such that the first conically shaped tip has a volume smaller than a volume of the second conically shaped tip. A length of the first conically shaped tip can be about the same as a length of the second conically shaped tip, wherein such length is measured along a longitudinal axis of the tapered body.
The tapered body of the diffuser in this embodiment can further include at least one vane positioned along a surface defined along a length of the tapered body. The at least one vane can include a peak having a height extending outward in a perpendicular direction from the surface of the tapered body. The height can taper along the length of the tapered body in a direction toward the outflow end. The tapering of the at least one vane along the length of the tapered body can be relative to the surface of the tapered body or relative to a longitudinal axis of the diffuser. A thickness of the at least one vane can be about 0.03 inches.
Another aspect of the present invention provides a method of manufacturing an implantable blood pump. The method includes providing a cannulated tip, a housing having an intake end and an outflow end, an impeller disposed in the housing and a diffuser disposed in the housing. The diffuser includes a tapered body and has a length between about 0.50 inches and less than 0.85 inches. The method further includes attaching the cannulated tip to an outflow end of the housing.
In yet another aspect of the present invention, a method of pumping blood and minimizing exposure to shear stresses is provided. The method includes providing a housing having an intake end and an outflow end, a cannulated tip extending from the outflow end of the housing, an impeller disposed in the housing, and a diffuser disposed in the housing. The diffuser includes a tapered body and has a length between about 0.50 inches and less than 0.85 inches. Then, surgically inserting the pump into an anatomical location in the human body. After inserting the pump, driving the pump using a power source so that blood is drawn into the intake end of the housing and pumped to the outflow end of the housing and through the cannulated tip of the blood pump into the patient's aorta.
A more complete understanding of the present invention, and the attendant advantages and features thereof, will be more readily understood by reference to the following detailed description when considered in conjunction with the accompanying drawings wherein:
The term blood pump, pump or device, as used throughout, is intended to refer generally to pumps which may be used within the vasculature, such as within the heart, the aorta, the various arteries or veins, or the like, or adjacent to the vasculature, such as adjacent to the wall of the heart, or within the abdomen adjacent to the heart or other vasculature. Typically, such blood pumps are implanted into the left or right ventricle of the heart and can pump through the aortic valve or a bypass conduit. One exemplary type of blood pump is a ventricular assist device, commonly referred to as a VAD, that is positioned to supplement the pumping of blood from the left ventricle into the aorta. While the blood pump is discussed below relative to its use as a VAD, the blood pump of the present invention may be used and implanted in a variety of anatomical locations to supplement blood flow throughout the vasculature.
Referring to the drawings, wherein like reference numerals refer to like elements, there is shown in
Outflow cannula 30 is shown in
Outflow cannula 30 is straight and has an appropriate stiffness and hardness to accommodate the native heart and aortic root geometry and also to have non-traumatic contact with tissues. The outflow cannula 30 is sized so that its cross-sectional shape helps to minimize retrograde flow through the valve due to poor sealing of the tri-leaflets around the cannula, that is to say, minimize aortic valve insufficiency. The illustrated circular cross-sectional shape also minimizes aortic valve insufficiency. The diameter of the outflow cannula relative to the housing is as shown in
As seen in
Extension body 50 is shown in
The blood pump 10 also includes an anchoring element in the form of a ring 60. Ring 60 is adapted for mounting adjacent the apex of the patient's heart and includes a spherical socket adapted to engage the spherical ball 61 such that ring 60 is pivotally mounted to extension body 50 remote from pump housing 40. The anchoring element can be any known to those of ordinary skill, such as those described in U.S. Pat. No. 8,852,072.
The blood pump 10 is started by applying power from a power source. For example, pump 10 can be powered through electrical power provided by an external or implantable power source. Power for pump 10 can be provided in ways known to those of ordinary skill in the art. For example, see U.S. Pat. No. 8,852,072.
An impeller 90 is disposed within pump housing 40 shown in
Examples of impeller 90 are shown in U.S. Pat. Nos. 7,699,508; 7,972,122; 8,007,254; 8,419,609; 8,852,072; and U.S. Pat. Pub. No. 2015/0051438, all of which are incorporated by reference herein as if fully set forth herein.
A diffuser 80 is disposed within pump housing 40 as shown in
As shown in
As described above, a pump housing with a tapered outlet portion is shorter than a pump housing without a tapered outlet. For example, the pump housing including a tapered outlet portion 41 can be about 0.30 inches shorter than prior art implantable pumps. In another example, when the diffuser 80 is 0.55 inches in length, the pump housing is approximately 0.36 inches shorter than a pump housing disposed with a diffuser 0.85 inches in length.
Numerous advantages may be realized with the use of a blood pump that includes an original or orange impeller as disclosed in U.S. Pat. Pub. No. 2015/0051438, incorporated by reference herein as if fully set forth herein, and a diffuser 80 having a tapered diffuser body 82, helical vanes 84 extending outward therefrom and a pump housing with a tapered outlet portion 41. One advantage is improved hydraulic performance, i.e., a net increase in pressure head, through pump housing 40. Using a computational fluid dynamics (CFD) model, performance of diffuser 80 was evaluated relative to a diffuser having a linear body and at least one perpendicular blade (not shown) disposed in a pump housing shaped parallel with axis 11 (i.e., cylindrical housing, not shown). The latter type of diffuser will hereinafter be referred to as an “original” diffuser. The CFD model geometry was developed from the 3D SolidWorks model of the pump by simplifying the geometry to obtain the fluid domain and the corresponding walls. Steady state solutions were obtained for the fluid properties of 2.6 cP viscosity and 1045 kg/m3 density. For a blood pump having the original impeller operating at a rotational speed of 18000 rpm and a flow rate of 5 L/min, pressure head increased from 39 mmHg to 65 mmHg when diffuser 80 replaced original diffuser. Similarly, for an orange impeller at a rotational speed of 16000 rpm and a flow rate of 6 L/min, pressure head increased from 36 mmHg to 52 mmHg when diffuser 80 replaced original diffuser. Pressure head was improved with the use of diffuser 80 over a range of flow rates in combination with either the original impeller or orange impeller, as shown in
As another example, the improved performance of diffuser 80 in the blood pump was also established through a high-resolution stereograph (SLA) analysis. This analysis was performed using 40/60% water/glycerol solution which provided 2.7-2.8 cP fluid viscosity at 37 C. For an original impeller operating at a rotational speed of 16000 rpm and a flow rate of 5 L/min, pressure head increased from 6 mmHg to 40 mmHg when diffuser 80 replaced original diffuser. Pressure head was similarly improved at rotational speeds of 18000 and 20000 rpm, as shown in
Another advantage of diffuser 80 is reduced exposure to shear stresses above 150 Pa and reduced exposure to wall shear stresses less than 1 Pa for a given flow rate and a given pressure head relative to an original diffuser. This is shown in
Yet another advantage of the blood pumps of the present invention results from the pump having a tapered outlet portion of the pump housing. For example, a blood pump with a housing having a tapered outlet portion 41 may cause less tissue damage during implantation and while implanted and in operation than prior art blood pumps. The diameter of the pump housing 40 is sized so there may be little interaction, or even no interaction, between pump housing 40 and surrounding tissue, including valve leaflets, during operation of the pump 10. Put another way, only outflow cannula 30 extends outside of the left ventricle and into the aorta.
Finally, because pump housing 40 allows for a diffuser 80 of shorter length than with prior art blood pumps, outflow cannula 30 may be longer than would otherwise be possible. As a result, greater flexibility is available in the arrangement of pump components and positioning of the blood pump 10. The physical structure of the present invention also improves the ease of use of the pump 10.
Numerous variations and combinations of the features discussed above can be used, some of which are discussed below as examples.
In other embodiments, the outlet portion 41, the central portion 42 and the inlet portion 43 can be of different geometric shapes and different combinations of shapes. For example, the slope of taper of the outer and inlet portions may be steeper or shallower as desired, and may be the same as one another or different from one another. Further, the slope of taper of either of the housing portions may vary along its length (e.g., the slope of the taper of outlet portion 41 varies along its length).
In another embodiment, the outflow cannula 30 can be curved or otherwise nonlinear. The cross-sectional shape of the outflow cannula can be any shape known by those of ordinary skill in the art. For example, see U.S. Pat. No. 8,852,072.
In yet another embodiment, impeller can be disposed at least partially in inlet portion 43 and/or outlet portion 41.
In another embodiment, diffuser can be disposed at least partially in central portion 42.
In another embodiment, the vanes 84 of the diffuser body 82 can be tapered along the axial length of the body such that a peak at the top of the height of the vanes becomes closer to a surface of the body when moving from first end 86 toward second end 87. Alternatively, as illustrated in
In yet another embodiment, Ring 60 can be configured to allow for rotational and/or angular movement, or complete universal movement, of the blood pump 10 to accommodate the native heart movement.
In any of the above embodiments, an inner surface of the housing can taper in parallel to a surface of the body of the diffuser with a cross-sectional area representing the flow path remaining constant at different points along the length of the housing. The flow path surrounding the diffuser has a cross-sectional area measured by taking a cross-sectional area bounded by the inner surface of the housing and subtracting the cross-sectional area of the diffuser inside. The inner surface of the housing can also taper relative to the surface of the body moving toward the outlet end such that the cross-sectional area representing the flow path increases closer to the outlet end. Finally, the inner surface of the housing can converge with the surface of the body moving toward the outlet end such that the area representing the flow path decreases closer to the outlet end. As above, any or all of the tapers can also have a varying slope along their individual length, rather than a constant slope, such that the cross-sectional area representing a particular flow path will change according to the varying taper.
In any of the above embodiments, the first, second, and third portions can be monolithic with one another such that they are formed as a unitary construction during manufacture. Alternatively, the first, second and third portions of the linear housing can also be independent of each other. Also in any of the above embodiments, portions of the first and third portions can be monolithic. For example, the central portion 42 can be monolithic with the outlet portion 41. In one variation, the central and outlet portions can be monolithic while the inlet portion is formed separately such that the impeller and diffuser can be positioned within the housing and can be sealed therein by securing the inlet portion thereto.
In another aspect, a method is provided for manufacturing pump 10. In this method, a cannulated tip 20, a housing 40, an impeller 90 and a diffuser 80 are provided. The housing includes an intake end and an outflow end. The impeller 90 and the diffuser 80 are disposed in the housing 40 and the cannulated tip 20 is attached to the outflow end of the housing 40.
In yet another aspect, a method is provided wherein the implantable blood pump 10 is used to pump blood. In one embodiment of this method, ring 60, extension body 50, pump housing 40 and outflow cannula 30 can be provided as a pre-assembled monolithic unit to facilitate implantation. By way of example, the surgeon gains access to the heart, using a left subcostal or left thoracotomy incision exposing the left ventricular apex. A pledgeted purse string suture is then applied to the epicardium circumferentially over the pump insertion site. A list incision or an incision in the form of a cross or X, commonly referred to as a “crux” incision, is made through the apex of the heart into the interior of the left ventricle using a cutting instrument such as a scalpel. Pump housing 40, extension body 50 and outflow cannula 30 are then inserted through the crux incision or slit incision and positioned within the left ventricle so that cannula 30 extends through the aortic valve into the aorta. Ring 60 is positioned on the outside of the heart (not shown). See, for example, U.S. Pat. No. 8,852,072.
When the blood pump is in the implanted condition, ring 60 is mounted adjacent the apex of the patient's heart. Ring 60 and pump housing 40 are connected to extension body 50 remote from one another so that extension body 50 maintains pump housing 40 in position relative to ring 60. Extension body 50 is sufficiently rigid to maintain the pump housing 40 and outflow cannula 30 in position relative to the heart. The implant and positioning of ring 60 and extension body 50 provide secure positioning of the pump housing 40 and outflow cannula 30 relative to the heart.
In the implanted condition, the outflow cannula 30 projects through the aortic valve into the ascending aorta, but terminates proximal to the arch of the aorta. The shape of pump housing 40 and in particular outflow portion 41 ensures that only the outflow cannula 30 and tip 20 interact with the aortic valve when pump 10 is implanted. The location of pump 10 relative to anatomy can be any location known to those of skill in the art. For example, see U.S. Pat. No. 8,852,072.
Operation is facilitated with the pump implanted in the body of a patient, and with the pump housing 40 connected into the circulatory system as, for example, in the conventional manner for a blood pump, and impeller 90 is actuated using means known in the art and/or those described above. For example, through the use of a power source. The impeller 90 is actuated in a manner so that it spins in the forward circumferential direction. The spinning impeller 90 retrieves and pumps blood from inlet 43 in the downstream direction toward diffuser 80. The spinning impeller also imparts angular momentum to the blood around the central axis 11 of the impeller 90. The operation of impeller 90 can be by any means known to those of skill in the art. For example, see U.S. Pat. Pub. No. 2015/0051438. As the blood encounters the diffuser 80, this angular momentum is converted to axial momentum and pressure head. The one or more vanes 84 of diffuser 80 serve to reclaim the energy used to create the angular motion and convert that energy to useful pumping work. The blood passes through outlet 46 and then through outflow cannula 30 once it is downstream of the diffuser 80, and exits blood pump 10 via cannula tip 20 for further distribution into the arterial system via the aorta. The blood from the left ventricle can be pumped into the aorta through an aortic valve or a bypass conduit.
Advantages of the above method include that pressure head using blood pump 10 is improved relative to prior art blood pumps. Also, critical volume and critical area at shear stresses greater than 150 Pa and at wall shear stresses less than 1 Pa are minimized through the above method using pump 10. Yet another advantage is that the shape of the pump housing 40 in combination with the shape of the diffuser 80 in the above method minimizes damage to tissue surfaces and interaction of pump 10 with the aorta.
In further embodiments, the method described above can be employed using pump housing 40 having portions 41, 42 and 43 of varying shapes and combinations of shapes. In these and still further embodiments, diffuser 80 and the vanes 84 can vary in shape and size as described above.
In still further embodiments, the pump housing 40 can be monolithic and the ring 60, extension body 50 and outflow cannula 30 can be assembled at time of surgery. In a further embodiment, the pump housing 40 can be monolithic with one or more of the ring 60, extension body 50, and/or outflow cannula 30. Finally, in other embodiments, combinations of the portions of the pump housing 40 can be assembled at the time of surgery.
Any of the above embodiments can include an implantable blood pump 10 implanted in areas of the vasculature other than the left ventricle or in areas adjacent to the vasculature.
The invention described herein provides at least three advantages. First, an implantable blood pump including a tapered housing and a tapered diffuser with a length shorter than traditional diffusers still provides increased blood pressure through the pump and into a patient's bloodstream than what could be done using prior art pumps. This is evidenced by the performance of the pump relative to prior art pumps as shown in
All publications, provisional patent applications, patent application publications and issued patents cited above are incorporated herein by reference as if fully set forth herein.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
This application is continuation of patent application Ser. No. 14/822,360, filed Aug. 10, 2015, entitled IMPLANTABLE PUMP WITH TAPERED DIFFUSER REGION and is related to and claims priority to U.S. Provisional Patent Application Ser. No. 62/035,003, filed Aug. 8, 2014, entitled IMPLANTABLE PUMP WITH TAPERED DIFFUSER REGION, the entirety of which are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62035003 | Aug 2014 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 14822360 | Aug 2015 | US |
| Child | 16025177 | US |
