Abstract:
The present invention includes various embodiments of methods of circulating blood in a mammalian circulatory system, and various blood circulation assemblies adapted to perform such circulation. In one embodiment of the present invention, a blood circulation assembly includes a blood circulation device having an inlet and a discharge; a first cannula including a proximal portion in communication with the inlet, the proximal portion having a wall extending around a first longitudinal axis and having outer and inner faces, said inner face defining a bore, and a distal portion including an outer face tapering distally toward said axis and at least two openings extending from said outer face and merging with one another to form a hollow space within said distal portion, said hollow space communicating with said bore of said proximal portion; and a second cannula including a proximal portion in communication with the discharge, the proximal portion having a wall extending around a first longitudinal axis and having outer and inner faces, said inner face defining a bore, and a distal portion including an outer face tapering distally toward said axis and at least two openings extending from said outer face and merging with one another to form a hollow space within said distal portion, said hollow space communicating with said bore of said proximal portion.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a continuation of U.S. patent application Ser. No. 12/460,281, filed on Jul. 16, 2009, which claims the benefit of the filing date of U.S. Provisional Patent Application No. 61/135,004 filed Jul. 16, 2008, the disclosures of which are incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates generally to a cannula which may be used, in some embodiments, with a Ventricular Assist Device (“VAD”). 
         [0003]    In certain disease states, the heart of a human or other mammalian subject lacks sufficient pumping capacity to meet the needs of the body. This inadequacy can be alleviated by providing a mechanical pump referred to as a Ventricular Assist Device (“VAD”) to supplement the pumping action of the heart. The intake of the VAD may be equipped with an intake cannula having an interior bore. The VAD and intake cannula may be positioned such that at least a portion of the intake cannula is positioned within a ventricle or atrium. This portion of the intake cannula, typically at or near an end of the cannula, includes an intake region where the interior bore of the cannula communicates with the surroundings. Thus, the VAD can take in blood from within the ventricle. 
         [0004]    The discharge of a VAD may be connected to the interior bore of a discharge cannula. The discharge cannula has a discharge region, typically at or near an end of the cannula, where the interior bore of the cannula communicates with the surroundings. The discharge region is positioned in an artery or vein, most commonly in the aorta. Thus, the VAD can discharge blood through the discharge cannula into the artery or vein. 
         [0005]    Other arrangements use cannulas with other blood pumping devices in a generally similar fashion. In general, the intake region of an intake cannula, or the discharge region of a discharge cannula, can be positioned within a portion of the circulatory system such as a vein, artery or coronary chamber. 
         [0006]    The intake or discharge region of the cannula should resist movement caused by the flow of blood into or out of the cannula. This allows the cannula to remain stable and minimizes or prevents injury to the surrounding tissue, such as the wall or valve of the heart, or blood vessel. It is also desirable to minimize flow resistance through the cannula, and particularly the flow resistance of the intake or discharge region. Moreover, the flow pattern of the blood entering or leaving the cannula should minimize turbulence and eddying, which may destabilize the cannula as well as damage the flowing blood. Additionally, the intake or discharge region should be resistant to accidental blockage or suction which may occur if the intake or discharge region comes in contact with the heart or blood vessel wall. The intake or discharge region should be free of features such as sharp edges or projections which can damage the surrounding tissue. Also, the intake or discharge region should have a shape which can be formed readily. All of these factors, taken together, present a significant engineering challenge. Thus, there has been a need in the art for further improvement in cannula design. 
       SUMMARY OF THE INVENTION 
       [0007]    One aspect of the present invention provides a cannula for use with a blood circulation device such as a VAD, the cannula having a longitudinal axis and proximal and distal directions along the longitudinal axis. The cannula may include a proximal portion having a wall extending around the longitudinal axis and having outer and inner faces. The inner face may define a bore, the proximal portion may have dimensions transverse to the longitudinal axis, and the dimensions may be constant in the proximal and distal directions. Also, the cannula may have a distal portion having an outer face, continuous with the outer face of the proximal portion. The outer face of the distal portion may extend around and along the longitudinal axis, and the outer face of the distal portion may taper distally toward the longitudinal axis. The distal portion may include at least two openings extending from the outer face of the distal portion. The openings desirably merge with one another within the distal portion. The openings may communicate with the bore of the proximal portion. At least a portion of each opening may be axially aligned with the bore, such that a straight line extending through the opening parallel to the longitudinal axis extends, unobstructed by any part of the cannula, into the bore. 
         [0008]    As further discussed below, certain embodiments of the cannula according to this aspect of the invention provide a desirable combination of low flow resistance, stability in use, minimal damage to the blood and other desirable properties. 
         [0009]    Another aspect of the invention also provides a cannula for use with a blood circulation device. The cannula according to this aspect of the invention desirably has a longitudinal axis and proximal and distal directions along the axis. The cannula according to this aspect of the invention desirably includes a proximal portion having a wall extending around the longitudinal axis and having outer and inner faces, said inner face defining a bore, as well as a distal portion having one or more openings communicating with the bore of the proximal portion. The cannula according to this aspect of the invention preferably has ports extending through the wall of the proximal portion and communicating with the bore in the proximal portion. The ports preferably have aggregate resistance to fluid flow which is substantial in comparison to the aggregate fluid flow resistance of the openings. In a method according to yet another aspect of the invention, the cannula is positioned to extend through a valve of the circulatory system of a mammalian subject such as a human, and blood is supplied to the bore. A substantial portion of the blood, and desirably a majority of the blood passes out of the cannula through the opening. However, some of the blood passes out of the cannula through the ports. As further discussed below, this flow of blood can minimize contact of the cannula with the valve, and thus minimize injury to the valve. 
         [0010]    A further aspect of the invention provides an assembly including a VAD and a cannula as discussed above connected to the intake of the VAD or to the discharge of the VAD. 
         [0011]    These and other aspects of the present invention will be described in more detail below. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]    These and other objects, features and advantages of the present invention will be more readily apparent from the detailed description of embodiments set forth below, taken in conjunction with the accompanying drawings, in which: 
           [0013]      FIG. 1  is a fragmentary perspective view depicting of a cannula according to one embodiment of the present invention. 
           [0014]      FIG. 2  is a plan view of the cannula of  FIG. 1 , taken along viewing line  2 - 2  in  FIG. 1 . 
           [0015]      FIG. 3  is a sectional view taken along line  3 - 3  in  FIG. 2 . 
           [0016]      FIG. 4  illustrates a side view of the cannula of  FIGS. 1-3 , taken along line  4 - 4  in  FIG. 2 . 
           [0017]      FIG. 5  is a cross-sectional view of the cannula of  FIGS. 1-4 , taken along line  5 - 5  in  FIG. 2 . 
           [0018]      FIG. 6  illustrates a cross-sectional view of the cannula of  FIGS. 1-5 , taken along line  6 - 6  in  FIG. 1 . 
           [0019]      FIG. 7  is a diagrammatic view depicting a VAD in conjunction with two cannulas according to  FIGS. 1-6 . 
           [0020]      FIG. 8  is a diagrammatic sectional view depicting a cannula according to a further embodiment of the invention in conjunction with an anatomical structure. 
           [0021]      FIG. 9  is an idealized, fragmentary sectional view on an enlarged scale depicting the region indicated in  FIG. 8 . 
           [0022]      FIG. 10  is a diagrammatic, partially sectional view depicting the cannula of  FIG. 8  in a different orientation relative to the anatomical structure. 
       
    
    
     DETAILED DESCRIPTION 
       [0023]    Referring to  FIGS. 1-7 , one embodiment of a cannula extends generally along a longitudinal axis AL. The directions along the longitudinal axis are referred to herein as proximal and distal directions. As used herein, the distal direction is the direction away from the end of the cannula which will be attached to the VAD in service, and toward the end of the cannula which will be remote from the VAD in service. For example, in the assembly of  FIG. 7 , a VAD  101  has an intake  103 , a discharge  105  and one or more internal pumping elements (not shown) arranged to impel blood taken in through intake  103  out through discharge  105 . One cannula  10 A has a proximal end  111  connected to the intake  103  of the VAD and has a distal end or distal-most point  17  remote from the VAD. Another cannula  10 B has its proximal end  111  connected to the discharge  105  of the VAD and has a distal end  17  remote from the VAD. In each cannula  10 , direction D is the direction away from the proximal end  111 . The distal direction is also indicated by arrow D in  FIGS. 1 ,  4 , and  5 . The proximal direction is the opposite direction along axis AL. 
         [0024]    Each cannula  10  includes a proximal portion  11 . As best seen in  FIG. 1 , the proximal portion includes a wall  12  which has an outer face  13  and an inner face  14 . The wall  12  extends around axis AL. The inner face  14  define a bore  30  through the proximal portion which also extends along axis AL and which extends toward the proximal end  111  ( FIG. 7 ) of the cannula. 
         [0025]    Face  13  extends in a smooth curve around longitudinal axis AL. Stated another way, in a cross-section of proximal portion  11  looking along axis AL, such as in  FIG. 3 , the line representing face  13  is a smooth, curve. In the particular embodiment depicted, face  13  is generally in the form of a circular cylinder, and hence the curve of face  13  is a circle. Likewise, inner face  14  is also in the form of a circular cylinder, and hence wall  12  has uniform dimensions in all of the radial directions perpendicular to axis AL. Wall  12  and its faces may have other cross-sectional shapes as, for example, ellipse, egg-shape, or the like. Desirably, the cross-sectional shape is a smooth curve and both faces  13  and  14  are smooth and without sharp edges, features or surfaces. In the embodiment depicted, the proximal portion  11  is of constant diameter. Stated another way, the dimensions of the proximal portion  11  perpendicular to axis AL are constant in the proximal and distal directions. 
         [0026]    Each cannula  10  includes a distal portion  15 , distal to the proximal portion  11 . Distal portion  15  has outer face  16  which extends around and along axis AL. Outer face  16  may be continuous with outer face  13  of proximal portion  11 . Outer face  16  tapers distally towards axis AL to the distal-most point  17 . As illustrated in the Figures, the taper of outer face  16  may be, for example, parabolic, thus maintaining a smooth curve along the entire outer surface  16  and distal-most point  17 . Moreover, outer face  16  has a convex, smooth, dome-like shape at distal-most point  17 . The outer face  16  may alternatively have a taper that is, for example, shaped like a circle, oval or the like which may have steeper or more gentle slope than the parabolic shape illustrated in the figures. At each point along the longitudinal axis AL, outer face  16 , leaving aside the openings  20  discussed below, has a cross-sectional shape which is a smooth curve around axis AL. In the particular embodiment shown, outer face  16  is a surface of revolution about longitudinal axis AL, so that as seen in cross-section viewing along the axis, as in  FIG. 6 , outer face forms a circular curve, interrupted only by the openings  20 . 
         [0027]    Distal portion  15  has at least two openings extending from the outer face  16  and into the interior volume of distal portion  15 . In the particular embodiment shown, there are three openings  20   a ,  20   b  and  20   c . Within the interior volume of distal portion  15 , the openings  20   a ,  20   b , and  20   c  merge with one another. The merged openings define a hollow space which communicates with bore  30  of proximal portion  11 . 
         [0028]    As best seen in  FIG. 5 , opening  20   b  extends along an individual opening axis AO. Opening  20   b  is generally in the form of a circular cylinder concentric with opening axis AO. The opening axis AO is oblique to axis AL, such that axis AO slopes inward, in the proximal direction, towards axis AL. In the particular embodiment depicted, opening axis AO and longitudinal axis AL define an included angle α of about 30 degrees. 
         [0029]    Opening  20   b  has a bounding surface  21 . Bounding surface  21  includes a cylindrical portion  24  in which the bounding surface lies at a constant distance from opening axis AO. In a portion of the opening on the distal side of opening axis AO, the cylindrical portion  24  extends substantially from outer face  16  to the point where opening  20   b  merges with other openings. In a portion of the opening  20   b  on the proximal side of the opening axis, the bounding surface  21  includes an outer portion  22  adjacent outer face  16 . Outer portion  21  has a slope towards axis OA, when moving in an inward direction along axis OA towards axis AL. Also, on the proximal side of the opening axis, bounding surface  21  includes an inner portion  23 , remote from outer face  16 , which slopes away from axis AO when moving in an inward direction along axis AO towards axis AL. The bounding surface  21  of opening  20   b  desirably is substantially free of sharp angles, edges, surfaces or features. 
         [0030]    Each of the other openings  20   a  and  20   c  has the same configuration as opening  20   b  discussed above. As best seen in  FIG. 2 , the openings  20   a - c  are evenly spaced on outer face  16  around axis AL. Further, openings  20   a - c  may be positioned at the same location in the proximal and distal directions on distal portion  15 . Thus, in this configuration, the openings  20   a - c  are uniformly spaced on distal portion  15  to form a symmetrically shaped and evenly balanced distal portion  15 . 
         [0031]    The distal portion  15  includes a solid tip  27 , disposed distal to the openings  20 . The proximal surface of tip  27  is defined by the bounding surfaces  21  of the openings  20 . Thus, the bounding surfaces  21  define the boundary between the hollow interior volume of distal portion  15  and the solid tip  27  of distal portion  15 , as is illustrated in  FIGS. 5-6 . 
         [0032]    In the embodiment depicted, the intersecting bounding surfaces  21  of mutually-adjacent openings  20   a  and  20   c  form a partial arch  50   ac . In like manner, the intersecting bounding surfaces of openings  20   a  and  20   b  form another partial arch,  50   ab  ( FIG. 6 ) and the intersecting bounding surfaces of openings  20   b  and  20   c  form another partial arch  50   bc.    
         [0033]    Each partial arch  50  may have a first end  51  at or near the proximal end of distal portion  15  of the cannula  10 , adjacent to the proximal portion  11 . The partial arch  50  may also have a second end  52  positioned on or near the axis AL. In the particular embodiment illustrated, the second end  52  is distal to the first end  51 . The second ends  52  of the partial arches  50  meet at the same location on the axis AL to form a peak  57  on the axis AL, best seen in  FIGS. 1 and 5 . Stated another way, the solid tip  27  has a point or peak  57  pointing in the proximal direction on axis AL. Each partial arch  50  also may have an apex or distal-most point  53  positioned between the first and second ends  51  and  52  of each partial arch  50 , respectively. 
         [0034]    The distal region  15  also includes an inner tapered surface  55  which joins the inner face  14  of the proximal portion. Surface  55  slopes inwardly in the distal direction to its intersection with the bounding surfaces  21  of the openings. In the embodiment depicted, surface  55  is substantially frustoconical. 
         [0035]    Openings  20  have substantial area for fluid flow. As referred to herein, the area of an opening is the area of the projection of the opening onto a viewing plane parallel to axis AL, such as the plane of the drawing in  FIG. 4 . Desirably, the aggregate area of all of the openings is greater than or the cross-sectional area of bore  30 , i.e., the area of the bore as seen in a plane perpendicular to axis AL. 
         [0036]    As best seen in  FIGS. 2 and 5 , in the particular embodiment depicted, each opening  20  is arranged so that at least a portion of the opening is axially aligned with bore  30 . That is, an imaginary particle moving along a line Z parallel to longitudinal axis AL extending through the opening has an uninterrupted path into bore  30 . 
         [0037]    The cannula  10  may be composed of any material suitable for insertion into the body. For example, ceramics, metals, polymers, or the like may be used to manufacture or make the cannula  10  so long as the material is bio-compatible and minimally thrombogenic. Other materials may be used which may be thrombogenic, so long as a bio-compatible, non-thrombogenic coating is applied to the surface of the material. Alternatively or additionally, the material of construction, or the coating, may inhibit cell or plaque growth or attachment thereon. In the particular embodiment depicted, the material is selected so that the cannula has some flexibility. For example, the cannula may be formed from a polymer such as silicone, polycarbonate, urethane with silicone, polystyrene-polyisobutylene-polystyrene (SIBS), and may have a flexible reinforcement such as a spiral-wound wire in the proximal portion. The cannula may include radioopaque materials so that the position of the cannula can be detected in X-ray based imaging techniques such as conventional X-ray imaging, fluoroscopic imaging, CAT scanning and the like. The radioopaque materials can be in the form of discrete markers positioned at known locations on the cannula. Alternatively or additionally, the materials of construction of the cannula may be radioopaque, as for example, polymers can be rendered radioopaque by dispersing certain metallic compounds in the polymers. Alternatively or additionally, the cannula may include discrete markers or dispersed materials which can be detected by other imaging modalities. For example, gadolinium-containing materials can be detected readily in some magnetic resonance imaging procedures, with good contrast to the surrounding tissues. 
         [0038]    In the embodiment depicted in  FIG. 7 , one cannula  10 A as discussed above is attached to the intake  103  of a VAD  101 , so that the bore  30  of the proximal portion communicates with the intake  103  of the VAD. Thus, this cannula  10 A serves as the intake cannula on the VAD. The distal portion  15  of cannula  10 A serves as the intake region. The VAD and cannula  10 A may be positioned such that at least a portion of the cannula  10 A, which includes the distal portion  15 , is positioned within a chamber in the heart, typically within a ventricle. 
         [0039]    Cannula  10 B, which is identical to cannula  10 A, is connected to the discharge  105  of the VAD, and thus serves as a discharge cannula. The distal portion  15  of cannula  10 B forms the discharge region. The distal portion or discharge region of cannula  10 B is positioned in an artery, most commonly in the aorta. 
         [0040]    The cannula discussed herein can be used with any VAD. Depending on the design of the VAD and the application, only one cannula can be used as an intake cannula or discharge cannula. For example, where the intake of the VAD is positioned within the ventricle, an intake cannula may not be required. Where the discharge of the VAD is disposed within the aorta or other artery, a discharge cannula maynot be required. 
         [0041]    The design of the distal portion  15 , of the cannula is believed to promote stability of the distal portion during use, and to minimize movement of the distal portion caused by the flow of blood into or out of the cannula. In particular, it is believed that the flow of blood with a radial component of velocity tends to hold the distal portion of the cannula away from neighboring solid tissues such as the wall of an artery or the heart wall. For example, where the cannula is used as an outflow cannula, the flow of blood with a radially outward component of velocity is believed to have this effect. Depending on the application and on the stiffness of the cannula, the stability of the distal portion may allow positioning of the cannula without the need for auxiliary devices to hold the cannula away from the wall of the heart or artery. Moreover, even if the cannula rests against the wall of the heart or artery, it will not be blocked; at least one opening  20  typically will remain open. Also, the distal portion minimizes flow resistance through the intake or discharge region  15  of the cannula  10 , and thus may alleviate turbulence and eddying. The smooth bounding surfaces  21  of openings  20  also help to minimize turbulence and eddying of blood passing through the openings. 
         [0042]    The smooth outer faces  13  and  16 , and tapered distal portion  15 , facilitate insertion of cannula  10 , and help to assure that cannula  10  does not damage the surrounding body tissue. In particular, the tapered and rounded distal portion  15  is believed to contribute to the ease of insertion. The convex, smooth, dome-like shape at distal-most point  17  is believed to contribute to ease of insertion. The taper of distal portion  15  may act as a distracter to safely separate the surrounding tissue during insertion. 
         [0043]    Numerous variations of the features discussed above may be used. For example, the embodiments discussed above have only a single bore in the proximal section. The bore can be subdivided to provide a multi-lumen cannula, in which different lumens communicate with different openings  20 . 
         [0044]    The number of openings may be varied as, for example, to use two or four openings or more. The dimensions of the cannula may be selected according to the required flow volume. Merely by way of example, a cannula for carrying about 5 l/min of blood has a bore  30  of about 6 mm interior diameter. The slopes of bounding surface  21  may be varied. The bounding surfaces discussed above are well-suited for use either as an intake cannula or a discharge cannula. 
         [0045]    The cannula discussed above can be employed with devices other than VADs, as for blood circulation systems such as heart-lung machines, dialysis systems and the like. 
         [0046]    A cannula  110  according to a further embodiment of the invention ( FIGS. 8 and 9 ) has a proximal end  121 , a distal region  115 , and a proximal region  111  extending from the distal region  115  towards the proximal end  121 . The cannula is provided with openings  120 , which desirably are positioned in or near the distal region  115 . The cannula has a bore  130  extending through the proximal region  111  and communicating with the openings  120 . Merely by way of example, these features may be similar to the corresponding features of the cannulas discussed above with reference to  FIGS. 1-7 . 
         [0047]    Cannula  110  also has ports  101  extending through the wall  112  of the cannula in the proximal region  111 . Stated another way, ports  101  are disposed proximally of openings  120 . Ports  101  extend between the bore  130  of the cannula and the outer surface  113  of the proximal region of the cannula. The ports may be spaced apart from one another around the circumference of the cannula, and also may be spaced apart along the axial length of the proximal region. In the embodiment depicted, the ports are provided in a few rows spaced axially from one another, so that the ports  101  are distributed over only a small portion of the axial length of the proximal region  111 . Although the ports  101  are depicted as regularly spaced, circular holes, this is not essential. The ports  101  may be irregularly shaped, irregularly spaced, or both. For example, the wall  112  of the proximal section may incorporate a section formed from a porous material having numerous very small pores which constitute ports  101 . The ports  101 , in the aggregate, desirably have flow resistance which is substantial in comparison to the flow resistance of the openings  120  in aggregate. As used in this disclosure, the “flow resistance” of the ports in the aggregate means the number obtained by dividing the ΔP by the total flow of blood per unit time through the ports, where ΔP is the difference between the pressure within the bore and the pressure outside of the cannula. Likewise, the flow resistance of the openings in the aggregate is the number obtained by dividing ΔP by the total flow of blood per unit time through the openings. Thus, when the cannula is used as a discharge cannula as depicted in  FIGS. 8 and 9 , a substantial portion of the blood flowing into the proximal end  121  of the cannula flows out of the cannula through the openings  120 . For example, the aggregate flow resistance of ports  101  may be greater than the aggregate flow resistance of openings  120 , so that the majority of the blood will be discharged through openings  120 . In some embodiments, the ratio of the aggregate flow resistance of ports  101  to the aggregate flow resistance of openings  120  is 5:1 to 10:1 or more, so that the openings  120  carry about 80% to 90% or more of the blood flowing into the proximal end  121 . 
         [0048]    In use, the cannula  110  is positioned to extend through a valve V of the circulatory system. For example, valve V may be the mitral valve, tricuspid valve, aortic valve or other valve of the heart, or may be a valve in a blood vessel. Valve V has a plurality of leaves L, two of which (L 1  and L 2 ) are depicted in  FIG. 8 . The valve is arranged to open so as to accommodate natural blood flow in a forward or downstream direction indicated by arrow F N  in  FIG. 8 . When the valve is open to accommodate a pulse of blood flow, leaves L 1  and L 2  move away from one another as indicated in broken lines at L 1 ′ and L 2 ′ in  FIG. 8 . When the pressure of blood downstream from the valve (below the valve in  FIG. 8 ) is above the pressure upstream of the valve, the pressure urges leaves L 1  and L 2  back to a closed position in which the leaves abut one another so that the valve closes to block retrograde flow. Cannula  110  is positioned so that the portion of proximal region  111  having ports  101  is disposed in alignment with the valve V. When valve V is urged to the closed condition, leaves L 1  and L 2  are urged towards the outer surface  113  of the cannula. However, the blood flowing outwardly through the ports  101  tends to keep the leaves slightly away from the surface of the cannula. This tends to minimize damage to the valve caused by repeated or prolonged contact with the cannula. 
         [0049]    As depicted in  FIG. 8 , the cannula is positioned for forward flow, so that the direction of flow through the cannula is the same as the direction of natural forward or downstream flow F N . Thus, the distal region and openings  120  are positioned on the downstream side of valve V. As shown in  FIG. 10 , the cannula may be positioned in the opposite direction, with openings  120  on the upstream side of the valve, to provide retrograde flow. In this arrangement as well, discharge of blood through ports  101  acts to protect the leaves of the valve and limit or eliminate contact with the cannula. The ports  101  may be provided in cannulas having outlets and distal regions configured differently from those discussed above with reference to  FIGS. 1-7 . 
         [0050]    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 embodiments disclosed herein and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.