CAVOPULMONARY ASSIST DEVICE AND ASSOCIATED METHOD
FIELD OF THE DISCLOSURE The present disclosure relates generally to intravascular implantable devices and methods for assisting blood flow of a patient.
BACKGROUND OF THE DISCLOSURE Some infants are born with only one functional heart ventricle instead of two. The ventricle is the muscular heart chamber that performs the work of pumping blood to the body (left ventricle) or to the lungs (right ventricle). If left untreated, infants born with only one functional ventricle will die. Conventionally, infants born with such a condition are treated surgically with a series of three surgical procedures. The first procedure is typically performed on newborn patients within two weeks from birth, the second procedure is performed at six to twelve months from birth, and the third procedure is performed at two to six years of age. The first surgical procedure has a survival rate of approximately 50-70%. The second and third procedures have generally higher survival rates. Conventionally, the second and third procedures cannot be performed in the newborn because these procedures divert the blood from the superior or inferior venae cavae directly into the arteries of the lungs, and thus passive blood flow must occur from the venae cavae through the lungs. In a newborn, the resistance of the arteries leading to the lungs is high. As a result, blood flow will not passively advance through the lungs. As currently practiced, the first procedure utilizes a shunt to divert blood from the aorta, where pressure is high, to the pulmonary arteries. The pressure from the aorta is high enough to push blood through the lungs. However, the use of
the shunt directly contributes the relatively high morbidity rate of the first procedure. The shunt creates a physiologic situation in which the blood flow to the body and the lungs must be delicately "balanced."
SUMMARY OF THE DISCLOSURE According to one aspect of the disclosure, a method of performing a cavopulmonary diversion procedure in a newborn patient includes the steps of positioning an inlet of a blood pump in a vena cava of the newborn patient, and anastomosing the vena cava to a pulmonary artery of the newborn patient. In certain implementations, the inlet of the blood pump is positioned in the superior vena cava. In other implementations, the inlet of the blood pump is positioned in the inferior vena cava. In yet other implementations, the blood pump is embodied with two inlets, one of which is positioned in the superior vena cava, the other of which is positioned in the inferior vena cava. In certain implementations, one or both of the venae cavae may be anastomosed to the right pulmonary artery. According to another aspect of the disclosure, an intravascular blood pump includes a housing, an impeller positioned in the housing, and an inflatable bladder positioned around a portion of the periphery of the housing. In certain implementations, the housing is cylindrically shaped, and the inflatable bladder extends around a portion of an outer circumferential surface of the cylindrically shaped housing. In other implementations, the inflatable bladder extends completely around the outer circumferential surface of the cylindrically shaped housing. According to yet another aspect of the disclosure, an intravascular axial blood pump is configured to draw blood from both opposite axial ends thereof. A flow deflector is positioned between the opposite axial ends of the pump and deflects blood radially outwardly therefrom.
In certain implementations, the pump is configured with (i) a first pump housing having a first inlet and a first outlet, and (ii) a second pump housing having a second inlet and a second outlet. The flow deflector is positioned between the first outlet and the second outlet. An impeller may be positioned in each pump housing. One or both of the pump housings may have an inflatable bladder positioned around a portion of the periphery thereof. In each of these or other implementations, the axial pump may include
(i) a first impeller configured to advance blood in a first direction, and (ii) a second impeller configured to advance blood in a second direction. The second direction is opposite the first direction. The flow deflector is positioned between the first impeller and the second impeller.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a diagrammatic view showing an intravascular blood pump operating to pump blood from the superior vena cava to the right pulmonary artery of a newborn patient; FIG. 2 is a simplified cross sectional view of an intravascular axial blood pump; FIG. 3 is a diagrammatic view showing an intravascular blood pump operating to direct blood flow from both the superior vena cava and the inferior vena cava to the right pulmonary artery of a newborn patient; and FIG. 4 is a simplified cross sectional view of an intravascular axial blood pump, note that the angle and helical orientation of the blades of the pump are not shown for clarity of description.
DETAILED DESCRIPTION OF THE DRAWINGS While the concepts of the present disclosure are susceptible to various modifications and alternative forms, specific exemplary embodiments thereof have been shown by way of example in the drawings and will herein be described in detail. It should be understood, however, that there is no intent to limit the disclosure to the particular forms disclosed, but on the contrary, the intention is to cover all modifications, equivalents, and alternatives following within the spirit and scope of the invention as defined by the appended claims. Referring now to FIGS. 1 and 2, there is shown a heart 10 of a newborn patient which has been treated with the concepts of the present disclosure. The concepts demonstrated in FIG. 1 are shown in the context of the treatment of a non-functional left heart ventricle such as in the case of, for example, hypoplastic left heart syndrome. However, the concepts demonstrated in FIG. 1 may also be used in the treatment of other ailments as well. As shown in FIG. 1, the superior vena cava 12 of the newborn patient is anastomosed to the right pulmonary artery 14. As such, blood is advanced from the superior vena cava 12 to the right pulmonary artery 14. To facilitate such advancement, a cavopulmonary assist device is implanted into the newborn patient. Specifically, an intravascular blood pump 16 is implanted into the superior vena cava 12 of the newborn patient. The blood pump 16 includes an inlet 18 that draws blood from the superior vena cava 12 and an outlet 20 which expels blood into the right pulmonary artery 14. It should be appreciated that although the entire blood pump 16 is shown positioned in the superior vena cava 12, a portion of the pump 16 (e.g., the outlet 20) may extend into the right pulmonary artery 14. The blood pump 16 may be embodied as any type of intravascular blood pump. One type of intravascular blood pump that may be used is an axial blood pump such as the axial blood pumps described in U.S. Patent No. 4,846,152 (with
some modification thereof). The entirety of U.S. Patent No. 4,846,152 is hereby incorporated by reference. An exemplary embodiment of a blood pump that may be utilized as the blood pump 16 is shown in FIG. 2. The blood pump 16 includes a pump body in the form of a cylindrically-shaped housing 22. An impeller 24 is positioned in the housing 22. In the exemplary embodiment of FIG. 2, the impeller 24 is embodied as a rotor 26 having a number of helically-arranged blades 28 extending therefrom. The rotor 26 rotates relative to a stator 30 which also has a number of helically-arranged blades 32 extending therefrom. The number, size, and orientation of the blades 28, 32 may be varied to fit the needs of a given pump design. The pump 16 is driven by a cable 36 which rotates within a sheath 38 that extends from the outside of the newborn patient's body. The cable 36 is driven by an external drive mechanism (not shown). The blood pump 16 has an inflatable bladder, such as a balloon 34, secured to an outer periphery of the housing 22. The balloon 34 may extend along only a portion of the axial length of the housing 22, as shown in FIG. 2. Alternatively, the balloon 34 may extend along the entire axial length of the housing 22. The balloon 34 may be configured to wrap around the entire outer circumferential surface of the housing 22. Alternatively, the balloon may wrap around only a portion of the outer circumferential surface of the housing 22. As shown in FIG. 1, the balloon 34 may be inflated or otherwise expanded into contact with the walls of the superior vena cava 12. This prevents blood recirculation around the implanted blood pump 16. It should be appreciated that the inflatable bladder described herein (e.g., the balloon 34) is but one exemplary device for preventing blood recirculation around the implanted blood pump 16. Other types of occlusive mechanisms for preventing blood recirculation around the pump 16 are also contemplated.
Referring now to FIGS. 3 and 4, there is shown the heart 10 of the newborn patient having been treated with additional concepts of the present disclosure. Similar to as described above in regard to FIG. 1, the concepts demonstrated in FIG. 3 are shown in the context of the treatment of a non-functional left heart ventricle such as in the case of, for example, hypoplastic left heart syndrome. However, the concepts demonstrated in FIG. 3 may also be used in the treatment of other ailments as well. As shown in FIG. 3, both the superior vena cava 12 and the inferior vena cava 42 of the newborn patient are anastomosed to the right pulmonary artery 14. As such, blood is advanced from both the superior vena cava 12 and the inferior vena cava 42 to the right pulmonary artery 14. To facilitate such advancement, a cavopulmonary assist device is implanted into the newborn patient. Specifically, an intravascular blood pump 46 is implanted into the newborn patient. The blood pump 46 includes a first inlet 48 that draws blood from the superior vena cava 12 and a second inlet 58 that draws blood from the inferior vena cava 42. As shown in FIG. 3, the inlets 48, 58 are on axial opposite ends of the pump 46 from one another. The blood pump 46 also includes a first outlet 50 and a second outlet 60, both of which expel blood into the right pulmonary artery 14. A flow deflector 62 directs pumped blood radially outwardly therefrom and into the right pulmonary artery 14. As with the pump of FIGS. 1 and 2, the blood pump 46 may be embodied as any type of intravascular blood pump. One type of intravascular blood pump that may be used is an axial blood pump such as the axial blood pumps described in U.S. Patent No. 4,846,152 (with some modification thereof). An exemplary embodiment of a blood pump that may be utilized as the blood pump 46 is shown in FIG. 4. The blood pump 16 includes a pump body in the form of a pair of cylindrically-shaped housings 72, 74. The axially outer ends of the housings 72, 74 define the inlets 48, 58, respectively, of the blood pump 46. The
axially inner ends of the housings 72, 74 define the outlets 50, 60, respectively, of the blood pump 46. An impeller 76, 78 is positioned in each of the housings 72, 74, respectively. In the exemplary embodiment of FIG. 4, the impellers 76, 78 are each embodied as a rotor 80 having a number of helically-arranged blades 82 extending therefrom. The rotor 80 rotates relative to a stator 88 which also has a number of helically-arranged blades 84 extending therefrom. The number, size, and orientation of the blades 82, 84 of the impellers 76, 78 may be varied to fit the needs of a given pump design. However, in the exemplary embodiment described herein, the rotor blades 82 and the stator blades 84 associated with the impeller 76 are oppositely angled relative to the rotor blades 82 and the stator blades 84 associated with the impeller 78. As such, when driven in the same direction by a common drive cable 36, the impellers 76, 78 direct blood in axial opposite directions from the pump inlets 48, 58 to the outlets 50, 60 of the blood pump 46, as shown by the arrows of FIG. 3. This common cable 36 rotates within a sheath 38 that extends from the outside of the newborn patient's body. The cable 36 is driven by an external drive mechanism (not shown). As shown in FIG. 4, the flow deflector 62 has a pair of oppositely facing annular surfaces 86. The diameter of each of the annular surfaces 86 increases gradually in a direction away from the stators 88. As such, blood exiting the outlets 50, 60 of the housings 72, 74 is directed radially outwardly into the right pulmonary artery 14. The blood pump 46 has an inflatable bladder, such as the balloon 34, secured to the outer periphery of the housings 72, 74. Similarly to as described above in regard to FIGS. 1 and 2, the balloons 34 may extend along only a portion of the axial length of the housings 72, 74, as shown in FIG. 4. Alternatively, the balloon 34 may extend along the entire axial length of one or both of the housings 72, 74. The
balloon 34 may be configured to wrap around the entire outer circumferential surface of the housings 72, 74. Alternatively, the balloon may wrap around only a portion of the outer circumferential surface of the housings 72, 74. As shown in FIG. 3, the balloons 34 may be inflated or otherwise expanded into contact with the walls of the superior vena cava 12 (in the case of the balloon 34 associated with the housing 72) and the walls of the inferior vena cava 42 (in the case of the balloon associated with the housing 74). This prevents blood recirculation around the implanted blood pump 46. It should be appreciated that the inflatable bladder described herein (e.g., the balloon 34) is but one exemplary device for preventing blood recirculation around the implanted blood pump 46. As with the pump 16, other types of occlusive mechanisms for preventing blood recirculation around the pump 46 are also contemplated. While the concepts of the present disclosure have been illustrated and described in detail in the drawings and foregoing description, such an illustration and description is to be considered as exemplary and not restrictive in character, it being understood that only the illustrative embodiments have been shown and described and that all changes and modifications that come within the spirit of the disclosure are desired to be protected. There are a plurality of advantages of the concepts of the present disclosure arising from the various features of the apparatus and methods described herein. It will be noted that alternative embodiments of each of the apparatus and methods of the present disclosure may not include all of the features described yet still benefit from at least some of the advantages of such features. Those of ordinary skill in the art may readily devise their own implementations of an apparatus and method that incorporate one or more of the features of the present disclosure and fall within the spirit and scope of the invention as defined by the appended claims.
For example, although described above in the context of newborns, the concepts of the present disclosure may also be utilized in the treatment of non- newborn patients. For instance, in particular regard to non-newborns, a blood pump similar to the blood pump 16 may be implanted in the inferior vena cava 42 to support cavopulmonary blood flow. In non-newborn patients that might need pump support, the drainage from the inferior vena cava 42 is a potential source of problems, thus, a unidirectional pump positioned in the inferior vena cava 42 may be utilized to provide mechanical flow support. Such a configuration would be similar to as shown in FIG. 1, except that the pump 16 would be positioned in the inferior vena cava 42 only. It should be appreciated that such an arrangement (i.e., a blood pump positioned in the inferior vena cava 42 only) is also contemplated for use in the treatment of newborns.