Implantable ventricular assist devices and methods

Various aspects of the present disclosure are directed toward implantable medical devices, systems, and methods for cardiac assistance.

FIELD

The present disclosure relates generally to medical devices and more specifically to implantable ventricular assist devices and supporting structures configured to operate within a patient's vasculature and that can be minimally invasively delivered via a catheter.

BACKGROUND

Cardiac assist devices (CAD) generally relate to systems that include a pump that assists heart function without replacing the heart in order to improve hemodynamics. Depending on the needs and demands of the patient, the pump may be placed outside the patient's body (extra- or para-corporeal devices), or within the patient's abdomen such as in the pericardial cavity beneath or above the diaphragm (intracorporeal device). Attempts have also been made to place such pumps within the patient's vasculature, including within the heart itself.

SUMMARY

According to one example (“Example 1”), an implantable medical device for cardiac assistance includes a main body configured to deploy within the aorta and including a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; and a branch member configured to deploy within the access site to fluidly connect with the lumen of the main body and including a pump configured to force blood flow through the branch member and into the lumen of the main body.

According to another example (“Example 2”), further to the implantable medical device of Example 1, the branch member is configured to implant within an atrium or a ventricle of a patient.

According to another example (“Example 3”), further to the implantable medical device of Example 2, the pump is configured to increase blood flow into the aorta for cardiac assistance.

According to another example (“Example 4”), the implantable medical device of any one of Examples 1-2, the branch member includes a sealing element near a first end configured to engage a tissue wall of the atrium or the left ventricle.

According to another example (“Example 5”), further to the implantable medical device of Example 4, the sealing element comprises a polymeric material.

According to another example (“Example 6”), further to the implantable medical device of Example 4, the flange configured to engage the tissue wall in a fluid tight fluid communication between the branch member and the lumen of the main body.

According to another example (“Example 7”), the implantable medical device of any one of Examples 1-6, the access site in the main body includes a fenestration and the branch member is configured to seal within the fenestration to fluidly connect the branch and the main body.

According to another example (“Example 8”), the implantable medical device of any one of Examples 1-6, the device further includes a portal arranged within the main lumen aligned with the access site in the main body, and the branch member is configured to implant within the portal to fluidly connect the branch and the main body.

According to another example (“Example 9”), the implantable medical device of any one of Examples 1-8, the pump is removably coupled to the branch member.

According to another example (“Example 10”), further to the implantable medical device of Example 9, the pump is configured to anchor within the branch member.

According to another example (“Example 11”), the implantable medical device of any one of Examples 1-10, the branch is configured to implant within the aorta adjacent or between an aortic valve.

According to another example (“Example 12”), the implantable medical device of any one of Examples 1-11, the pump is powered remotely.

According to another example (“Example 13”), the implantable medical device of any one of Examples 1-12, the branch member is configured to couple the atrium and the aorta and allow independent motion of the atrium and the aorta.

According to another example (“Example 14”), the implantable medical device of any one of Examples 1-13, the pump is configured to deliver the blood flow through the branch member and into the lumen of the main body parallel to natural blood flow through the aorta.

According to one example (“Example 15”), a system for implanting an implantable medical device for cardiac assistance including a first catheter configured to deploy an implantable medical device within an aorta, the implantable medical device including a main body and a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; and a second catheter configured to deploy a branch member within the access site to fluidly connect with the lumen of the main body and including a pump configured to force blood flow through the branch member and into the lumen of the main body.

According to another example (“Example 16”), further to the system of Example 15, the second catheter is configured to deploy the branch member transapically.

According to another example (“Example 17”), further to the system of Example 15, the second catheter is configured to deploy the branch member transseptally.

According to another example (“Example 18”), the system of any one of Examples 15-17, the system also includes a puncture device configured to create an access site in the aorta and an access site in an atrium or ventricle, and wherein the second catheter is configured to deploy the branch member across the access site in the aorta and the access site in an atrium or left ventricle.

According to another example (“Example 19”), further to the system of Example, the second catheter includes a sheath configured to deploy a flange arranged with a distal end of the branch member, the flange configured to engage a tissue wall of the atrium or the ventricle in a fluid tight fluid communication between the branch member and the lumen of the main body.

According to one example (“Example 20”), method for implanting an implantable medical device for cardiac assistance includes arranging a first catheter within the aorta to deploy an implantable medical device within the aorta, the implantable medical device including a main body and a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; and arranging a second catheter within the access site to fluidly connect a branch member with the lumen of the main body, the branch member including a pump configured to force blood flow through the branch member and into the lumen of the main body.

According to another example (“Example 21”), further to the method of Example 21, the second catheter is configured to deploy the branch member transapically.

According to another example (“Example 22”), further to the method of Example 22, the second catheter is configured to deploy the branch member transseptally.

According to one example (“Example 23”), an implantable medical device for cardiac assistance includes a main body configured to deploy within an aorta, the main body including a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; a branch member configured to deploy within the access site to fluidly connect with the lumen of the main body and within a left atrial appendage of a heart; and a pump configured to force blood flow through the branch member and into the lumen of the main body.

According to another example (“Example 24”), further to the device of Example 23, the device also includes a stent structure coupled to the branch member or the pump and configured to stabilize the branch member or the pump within the left atrial appendage.

According to another example (“Example 25”), further to the device of Example 24, the branch member or the pump is arranged through an eyelet of the stent structure.

According to another example (“Example 26”), further to the device of Example 25, the stent structure includes an acorn shape or a shape that tapers toward a distal end.

According to one example (“Example 27”), an implantable medical device for cardiac assistance includes a branch member including a first end portion configured to deploy within a left atrial appendage of a heart and a second end portion configured to deploy within an aorta, the branch member being configured to interface with a pump to pass blood flow through a lumen of the branch member from the left atrial appendage into the aorta.

According to another example (“Example 28”), further to the device of Example 27, the devices also includes the pump configured to intake blood from the left atrial appendage and discharge the blood into the aorta.

According to another example (“Example 29”), further to the device of Example 28, the outflow of the pump is directly implanted into the aorta through the branch member.

According to another example (“Example 30”), further to the device of Example 29, the second end portion includes a flange configured to engage the tissue wall in a fluid tight fluid communication between the branch member and the tissue wall of the aorta.

According to another example (“Example 31”), further to the device of Example 30, the device also includes a stent structure coupled to the branch member and configured to stabilize the branch member or the pump within the left atrial appendage.

According to one example (“Example 32”), an implantable medical device for cardiac assistance includes a main body configured to deploy within the aorta and including a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; a branch member configured to deploy within the access site to fluidly connect with the lumen of the main body; and a pump arranged within a chamber of the heart and configured to force blood flow through the branch member and into the lumen of the main body.

According to another example (“Example 33”), further to the implantable medical device of Example 32, the branch member is arranged about a patient's heart.

According to another example (“Example 34”), further to the implantable medical device of Example 33, the pump is configured to implant within a left ventricle of the patient's heart and force blood flow through the branch member and into the lumen of the main body.

According to another example (“Example 35”), further to the implantable medical device of any one of Examples 32-34, the main body and the branch member form a non-surgical anastomosis with the aorta and the pump is configured to direct the blood flow into the aorta in line with or parallel to native flow.

According to one example (“Example 36”), an implantable medical device for cardiac assistance includes a pump configured to deploy within a pulmonary vein and including a lumen maintaining fluid flow through the pulmonary vein and configured to force blood flow through the lumen.

According to another example (“Example 37”), further to the implantable medical device of Example 35, the pump is configured to intake blood from the pulmonary vein and discharge the blood into the left atrium.

According to another example (“Example 38”), further to the implantable medical device of any one of Examples 35-36, the pump is configured to increase flow out of the pulmonary vein to increase cardiac output.

According to another example (“Example 39”), further to the implantable medical device of any one of Examples 35-38, the device also includes a driveline configured to power the pump and arranged out of the pulmonary vein into the left atrium and across a septum to exit a right side of the heart.

According to another example (“Example 40”), further to the implantable medical device of Example 39, the driveline exits a patient via an iliac vein.

According to one example (“Example 41”), a method for cardiac assistance includes arranging an implantable medical device between an aorta and a heart chamber of a patient, the implantable medical device including a pump configured to force blood flow from the heart chamber into the aorta; and forming a conduit of native tissue about the pump and between the aorta and the heart chamber.

According to another example (“Example 42”), further to the method of Example 41, forming the conduit of native tissue includes creating scarring or tissue ingrowth to form a tissue layer between the aorta and the heart chamber.

According to another example (“Example 43”), further to the method of any one of Examples 41-42, the pump includes a material arranged about an outer surface of the pump configured to facilitate tissue ingrowth.

According to another example (“Example 44”), further to the method of Example 42, the material includes at least one of Dacron and ePTFE.

According to an example (“Example 45”), a medical device for cardiac assistance includes a prosthetic valve comprising: a support frame, a plurality of leaflets coupled to the support frame and configured to open to allow forward flow therethrough and to occlude the support frame to prevent retrograde flow, and a pump arranged with the support frame and configured to force blood through the support frame.

According to another example (“Example 46”), further to the medical device of Example 45, the plurality of leaflets are configured to coapt about the pump arranged within the support frame.

According to another example (“Example 47”), further to the medical device of Example 46, the pump is arranged centrally within the support frame.

According to another example (“Example 48”), further to the medical device of any one of Examples 45-47, the device also includes a filter arranged at an outflow end of the support frame.

According to another example (“Example 49”), further to the medical device of Example 48, wherein the filter is arranged on an outflow end of the pump.

According to another example (“Example 50”), further to the medical device of any one of Examples 45-49, the prosthetic valve is configured to replace an aortic valve of a patient.

According to another example (“Example 51”), further to the medical device of any one of Examples 45-50, the prosthetic valve is configured to replace a mitral valve of a patient.

According to another example (“Example 52”), further to the medical device of any one of Examples 45-51, the prosthetic valve and the pump are configured to transcatheter delivery.

According to one example (“Example 53”), an implantable medical device for cardiac assistance includes a main body configured to deploy within the aorta and including a lumen maintaining fluid flow through the aorta; a branch member extending from the main body and configured to deploy within a chamber of the heart to fluidly connect the aorta and the chamber of the heart; and a pump arranged within the branch member and configured to force blood flow from the chamber of the heart through the branch member and into the lumen of the main body.

According to another example (“Example 54”), further to the medical device of Example 53, the branch member is integral with the main body.

According to another example (“Example 55”), further to the medical device of Example 53, the branch member is configured to telescope inwardly and outwardly relative to the main body.

According to one example (“Example 56”), a method of deploying the medical device of any one of Examples 53-55 includes deploying the main body within the aorta; creating openings in the aorta and in the chamber of the heart; and deploying the branch member across the aorta and the chamber of the heart.

According to one example (“Example 57”), an implantable medical device for cardiac assistance includes a main body configured to deploy within the aorta and including a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; and a branch member configured to deploy within the access site to fluidly connect with the lumen of the main body and interface with a pump to pass blood flow through the branch member into the main body.

According to another example (“Example 58”), further to the medical device of Example 57, the branch member is configured to anchor the pump within the branch member.

According to another example (“Example 59”), further to the medical device of Example 58, the branch member includes an attachment mechanism configured to anchor the pump within the branch member.

According to another example (“Example 60”), further to the medical device of any one of Examples 58-59, the branch member and the pump include complementary attachment mechanisms to anchor the pump within the branch member.

According to another example (“Example 61”), further to the medical device of any one of Examples 58-60, the branch member is configured to frictionally engage with the pump to anchor the pump within the branch member.

According to another example (“Example 62”), a method of deploying the medical device of any one of Examples 58-61 includes deploying the main body within the aorta; creating openings in the aorta and in the chamber of the heart; and deploying the branch member across the aorta and the chamber of the heart.

According to one example (“Example 63”) a medical device for cardiac assistance includes a prosthetic valve having a support frame configured to implant within the patient and interface with a pump to pass blood flow therethrough; and a plurality of leaflets coupled to the support frame and configured to open to allow forward flow therethrough and to occlude the support frame to prevent retrograde flow.

According to another example (“Example 64”), further to the medical device of Example 63, the support frame is configured to anchor the pump within the branch member.

According to another example (“Example 65”), further to the medical device of Example 64, the support frame includes an attachment mechanism configured to anchor the pump within the branch member.

According to another example (“Example 66”), further to the medical device of any one of Examples 64-65, the support frame and the pump include complementary attachment mechanisms to anchor the pump within the branch member.

According to another example (“Example 67”), further to the medical device of any one of Examples 63-64, wherein the support frame is configured to frictionally engage with the pump to anchor the pump within the branch member.

According to one example (“Example 68”), an implantable medical device for cardiac assistance includes a main body configured to deploy within the aorta and including a lumen maintaining fluid flow through the aorta; and a branch member extending from the main body and configured to deploy within a chamber of the heart to fluidly connect the aorta and the chamber of the heart and interface with a pump to pass blood flow through the branch member into the main body.

According to another example (“Example 69”), further to the medical device of Example 68, the branch member is configured to anchor the pump within the branch member.

According to another example (“Example 70”), further to the medical device of Example 69, the branch member includes an attachment mechanism configured to anchor the pump within the branch member.

According to another example (“Example 71”), further to the medical device of any one of Examples 69-70, the branch member and the pump include complementary attachment mechanisms to anchor the pump within the branch member.

According to another example (“Example 72”), further to the medical device of any one of Examples 66-71, the branch member is configured to frictionally engage with the pump to anchor the pump within the branch member.

According to one example (“Example 73”), an implantable medical device for cardiac assistance includes a stent-graft configured to deploy within a pulmonary vein and including a lumen maintaining fluid flow through the pulmonary vein and configured to interface with a pump to pass blood flow through the lumen.

According to another example (“Example 74”), further to the medical device of Example 73, further including the pump configured to intake blood from the pulmonary vein and discharge the blood into the left atrium.

According to one example (“Example 75”) an implantable medical device for cardiac assistance includes a main body configured to deploy within the aorta and including a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; a branch member configured to deploy within the access site to fluidly connect with the lumen of the main body; and a pump configured to force blood flow through the branch member and into the lumen of the main body and including an anchor element configured to removably fix the pump within the branch member.

According to another example (“Example 76”), further to the implantable medical device of Example 75, the anchor element is at least one hinge structure configured to articulate a portion of the pump and maintain the pump in an angled configuration.

According to another example (“Example 77”), further to the implantable medical device of Example 76, the pump includes a tubular portion and the hinge structure is arranged circumferentially within or about the tubular portion.

According to another example (“Example 78”), further to the implantable medical device of Example 77, the hinge structure includes a plurality of discrete rings configured to maintain the tubular portion in the angled configuration in response to an applied force.

According to another example (“Example 79”), further to the implantable medical device of Example 75, the anchor element is arranged on an external surface of the pump and configured to expand and engage an interior surface of the branch member.

According to another example (“Example 80”), further to the implantable medical device of Example 79, the anchor element is an expandable balloon configured to expand and engage an interior surface of the branch member.

According to another example (“Example 81”), further to the implantable medical device of Example 80, the expandable balloon is arranged circumferentially about the pump.

According to another example (“Example 82”), further to the implantable medical device of Example 79, the anchor element is spring arranged on the external surface of the pump and an expandable balloon is configured to collapse the spring in response to inflation.

According to another example (“Example 83”), further to the implantable medical device of Example 75, wherein the anchor element includes a plurality of flanges extending radially from an end portion of the pump.

According to another example (“Example 84”), further to the implantable medical device of Example 75, the device also includes a receiving structure arranged on an internal surface of the branch member and wherein the anchor element is configured to engage the receiving structure to removably fix the pump within the branch member.

According to another example (“Example 85”), further to the implantable medical device of Example 84, the anchor element is a stent and the receiving structure is configured to contain the stent to removably fix the pump within the branch member.

According to another example (“Example 86”), further to the implantable medical device of Example 84, the anchor element is a protrusion and the receiving structure is a shaped notch configured to contain the protrusion to removably fix the pump within the branch member.

According to another example (“Example 87”), further to the implantable medical device of Example 84, the anchor element is a first threaded member and the receiving structure is a second threaded member and the first threaded member and the second threaded member are configured to engage to removably fix the pump within the branch member.

According to another example (“Example 88”), further to the implantable medical device of any one of Examples 86-87, the pump is configured to facilitate engagement between the anchor element and the receiving structure.

According to an example (“Example 89”), an implantable medical device for cardiac assistance includes a main body configured to deploy within the aorta and including a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; and a pump configured to deploy within the access site and to force blood flow through the pump and into the lumen of the main body, the pump including an expandable braided structure configured to removably fix the pump within the main body.

According to another example (“Example 90”), further to the implantable medical device of Example 89, the expandable braided structure includes a snaring element configured to facilitate collapsing of the expandable braided structure in response to tension.

According to another example (“Example 91”), a method of deploying an implantable medical device for cardiac assistance includes arranging a main body within the aorta, the main body including a lumen maintaining fluid flow through the aorta and an access site in a sidewall of the main body providing access to the lumen of the main body; deploying a branch member within the access site to fluidly connect with the lumen of the main body; and anchoring a pump configured to force blood flow through the branch member and into the lumen of the main body with the branch member using an anchor element configured to removably fix the pump within the branch member.

According to another example (“Example 92”), further to the method of Example 91, the anchor element is at least one hinge structure configured to articulate a portion of the pump and maintain the pump in an angled configuration and anchoring the pump includes arranging the at least one hinge structure within the branch member.

According to another example (“Example 93”), further to the method of Example 91, the anchor element is arranged on an external surface of the pump and configured to expand and engage an interior surface of the branch member and anchoring the pump includes expanding and engaging the anchor element to engage the interior surface of the branch member.

According to another example (“Example 94”), further to the method of Example 91, the implantable medical device includes a receiving structure arranged on an internal surface of the branch member and anchoring the pump includes engaging the anchor element with the receiving structure to removably fix the pump within the branch member.

According to one example (“Example 95”), an implantable medical device for cardiac assistance includes a main body configured to be disposed within the aorta, the main body including a lumen operable to convey blood through the aorta; an access site in a sidewall of the main body operable to provide access to the lumen of the main body; and a branch member configured to be disposed within the access site to fluidly connect with the lumen of the main body, the branch member includes one or more anchor elements configured to interface with and secure a pump with the branch member.

According to another example (“Example 96”), further to the device of Example 95, the branch member is configured to be disposed within an atrium or a ventricle of a patient.

According to another example (“Example 97”), further to the device of Example 96, the device also includes the pump and the pump is configured to convey blood into the aorta from the atrium or ventricle for cardiac assistance through the branch member and into the main body.

According to another example (“Example 98”), further to the device of any one of Examples 95-97, the branch member includes a sealing element near a first end configured to engage a tissue wall of a left atrium or a left ventricle.

According to another example (“Example 99”), further to the device of Example 98, the sealing element includes a flange configured to engage the tissue wall.

According to another example (“Example 100”), further to the device of any one of Examples 95-99, the access site in the main body includes a fenestration, the branch member is configured to seal with the fenestration to fluidly connect the branch member and the main bod.

According to another example (“Example 101”), further to the device of any one of Examples 95-99, the device also includes a portal arranged within the main lumen that is aligned with the access site in the main body, and a first portion of the branch member is configured to be disposed within the portal to fluidly connect the branch member and the main body.

According to another example (“Example 102”), further to the device of any one of Examples 95-101, a second portion of the branch member is configured to be disposed within the access site to fluidly connect with the lumen of the main body and a left atrial appendage of a heart.

According to another example (“Example 103”), further to the device of Example 102, the device also includes a stent structure coupled to the branch member or the pump and configured to stabilize the branch member or the pump within the left atrial appendage.

According to another example (“Example 104”), further to the device of Example 103, the branch member or the pump is arranged through an eyelet of the stent structure.

According to another example (“Example 105”), further to the device of Example 104, the stent structure defines an acorn shape or a shape that tapers toward a distal end.

According to another example (“Example 106”), further to the device of Example 95, the branch member is arranged about a patient's heart.

According to another example (“Example 107”), further to the device of Example 95, the pump includes one or more pump anchor elements, wherein the one or more branch anchor elements are operable for cooperative engagement with the one or more pump anchor elements and configured to anchor the pump with the branch member.

According to another example (“Example 108”), further to the device of Example 95, the one or more branch anchor elements are configured to frictionally engage the branch member and the pump to anchor the pump within the branch member.

According to another example (“Example 109”), a system for implanting an implantable medical device for cardiac assistance includes a first catheter configured to deploy an implantable medical device within an aorta, the implantable medical device including a main body, the main body including a lumen operable to maintain fluid flow through the aorta, the main body including an access site in a sidewall of the main body providing access to the lumen of the main body; and a second catheter configured to deploy a branch member within the access site to fluidly connect with the lumen of the main body and including a pump configured to convey blood through the branch member and into the lumen of the main body.

According to another example (“Example 110”), further to the system of Example 109, the second catheter is configured to deploy the branch member transapically.

According to another example (“Example 111”), further to the system of Example 109, the second catheter is configured to deploy the branch member transseptally.

According to another example (“Example 112”), further to the system of any one of Examples 109-111, the system also includes a puncture device configured to create an access site in the aorta and an access site in an atrium or ventricle, and wherein the second catheter is configured to deploy the branch member across the access site in the aorta and the access site in an atrium or left ventricle.

According to another example (“Example 113”), further to the system of Example 112, the second catheter includes a sheath configured to deploy a flange arranged with a distal end of the branch member, the flange is configured to engage a tissue wall of the atrium or the ventricle in a fluid tight engagement.

According to one example (“Example 114”), an implantable medical device for cardiac assistance a pump configured to deploy within a pulmonary vein, the pump including a lumen configured to maintain blood flow through the pulmonary vein and configured to convey blood through the lumen.

According to another example (“Example 115”), further to the device of Example 114, the pump is configured to intake blood from the pulmonary vein and discharge the blood into the left atrium.

According to another example (“Example 116”), further to the device of any one of Examples 114-115, the pump is configured to increase flow out of the pulmonary vein to increase cardiac output.

According to another example (“Example 117”), further to the device of any one of Examples 114-117, the device also includes a driveline configured to power the pump, the driveline configured to extend out of the pulmonary vein into the left atrium and across a septum to exit a right side of the heart.

According to another example (“Example 118”), further to the device of Example 117, the driveline is operable to exit a patient via an iliac vein.

According to another example (“Example 119”) a method for cardiac assistance including arranging an implantable medical device between an aorta and a heart chamber of a patient, the implantable medical device including a pump configured to convey blood from the heart chamber into the aorta; and forming a conduit of native tissue about the pump and between the aorta and the heart chamber.

According to another example (“Example 120”), further to the method of Example 119, forming the conduit of native tissue includes creating scarring or tissue ingrowth to form a tissue layer between the aorta and the heart chamber.

According to another example (“Example 121”), further to the method of any one of Examples 119-120, the pump includes a material arranged about an outer surface of the pump configured to facilitate tissue ingrowth.

According to another example (“Example 122”), further to the method of Example 121, the material includes at least one of Dacron and ePTFE.

According to one example (“Example 123”), a medical device for cardiac assistance includes a support frame, a plurality of leaflets coupled to the support frame and configured to open to allow forward flow therethrough and to occlude the support frame to prevent retrograde flow, and a pump arranged within the support frame and configured to convey blood through the support frame.

According to another example (“Example 124”), further to the device of Example 123, the plurality of leaflets are configured to coapt about the pump.

According to another example (“Example 125”), further to the device of Example 124, the pump is arranged centrally within the support frame.

According to another example (“Example 126”), further to the device of any one of Examples 123-125, the device also includes a filter arranged at an outflow end of the support frame.

According to another example (“Example 127”), further to the device of Example 126, the filter is arranged on an outflow end of the pump.

According to another example (“Example 128”), further to the device of any one of Examples 123-127, the prosthetic valve is configured to replace an aortic valve of a patient.

According to another example (“Example 129”), further to the device of any one of Examples 123-128, the prosthetic valve is configured to replace a mitral valve of a patient.

According to another example (“Example 130”), further to the device of any one of Examples 123-129, the prosthetic valve and the pump are configured for transcatheter delivery.

According to another example (“Example 131”), an implantable medical device for cardiac assistance include a main body configured to deploy within an aorta, the main body including a lumen configured to maintain fluid flow through the aorta; a branch member extending from the main body and configured to deploy within a chamber of a heart to fluidly connect the aorta and the chamber of the heart; and a pump arranged within the branch member and configured to convey blood from the chamber of the heart through the branch member and into the lumen of the main body.

According to another example (“Example 132”), further to the device of any Example 131, the branch member is integral with the main bod.

According to another example (“Example 133”), further to the device of Example 132, the branch member is configured to telescope inwardly and outwardly relative to the main body.

According to another example (“Example 134”), an implantable medical device for cardiac assistance includes a stent-graft configured to deploy within a pulmonary vein and including a lumen configured to maintain fluid flow through the pulmonary vein, the stent-graft configured to receive blood through the lumen.

According to another example (“Example 135”), further to the device of Example 134, the stent-graft configured to interface with a pump, and the pump configured to convey blood from the pulmonary vein to a left atrium.

The foregoing Examples are just that, and should not be read to limit or otherwise narrow the scope of any of the inventive concepts otherwise provided by the instant disclosure. While multiple examples are disclosed, still other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative examples. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive in nature.

DETAILED DESCRIPTION

Definitions and Terminology

As the terms are used herein with respect to ranges of measurements “about” and “approximately” may be used, interchangeably, to refer to a measurement that includes the stated measurement and that also includes any measurements that are reasonably close to the stated measurement, but that may differ by a reasonably small amount such as will be understood, and readily ascertained, by individuals having ordinary skill in the relevant arts to be attributable to measurement error, differences in measurement and/or manufacturing equipment calibration, human error in reading and/or setting measurements, adjustments made to optimize performance and/or structural parameters in view of differences in measurements associated with other components, particular implementation scenarios, imprecise adjustment and/or manipulation of objects by a person or machine, and/or the like. In the event it is determined that individuals having ordinary skill in the relevant arts would not readily ascertain values for such reasonably small differences, the terms “about” and “approximately” can be understood to mean plus or minus 10% of the stated value.

Certain terminology is used herein for convenience only. For example, words such as “top”, “bottom”, “upper,” “lower,” “left,” “right,” “horizontal,” “vertical,” “upward,” and “downward” merely describe the configuration shown in the figures or the orientation of a part in the installed position. Indeed, the referenced components may be oriented in any direction. Similarly, throughout this disclosure, where a process or method is shown or described, the method may be performed in any order or simultaneously, unless it is clear from the context that the method depends on certain actions being performed first.

Description of Various Embodiments

Various aspects of the present disclosure are directed to systems and methods for improving or assisting the cardiac function of the heart. The disclosed systems and methods generally include an endoprosthesis having a pump within the patient's vasculature. The disclosed systems and methods also include a delivery system configured for transcatheter delivery of the pump and the branch member.

In the instant disclosure, the examples are primarily described in association with transcatheter cardiac applications involving the aorta (also referred to herein as ventricular assist), although it should be readily appreciated that the various embodiments and examples discussed herein can be applied in association with any known uses of ventricular assist devices, including for use within other regions of the heart or vasculature, as well as percutaneous procedures (e.g., laparoscopic) and/or surgical procedures. Cardiac assist devices, as discussed herein, may be beneficial for patients experiencing heart failure. The cardiac assist devices, consistent with various aspects of the present disclosure may include an implantable pump that forces or conveys blood from chambers of the heart (e.g., the right ventricle or left ventricle) to the rest of the body (e.g., via the aorta).

As shown inFIG.1, a system1000according to various embodiments includes a branch member100and a pump200disposed at least partially within the branch member100, and a retention element300configured to help maintain a position of the pump200within the branch member100. The branch member100may be a branch member100that forms a part of a branched implantable medical device as discussed in further detail below.

In certain instances, the branch member100may include a graft, a stent, or a combination of a stent and a graft. As discussed in further detail below, the branch member100may be a stent-graft device that is incorporated with a stent-graft device implanted into a patient's aorta thereby forming a branched implantable medical device. The branch member100may be a branch member coupled or joined to a main stent-graft device that is implanted in the aorta. In certain instances, the branch member100and pump200may act as a right ventricular assist device and increase blood flow into the pulmonary veins or arteries. In these instances, the main body208may be placed in the pulmonary artery with the branch member100be arranged in the atrium or ventricular as discussed in detail herein

In certain instances, the stent portion of a branch member100is defined by a plurality of interconnected strut elements. The stent portion of the branch member100may comprise, such as, but not limited to, elastically deformable metallic or polymeric biocompatible materials. The stent portion of the branch member100may comprise a shape-memory material, such as nitinol, a nickel-titanium alloy. Other materials suitable for the stent portion of the branch member100include, but are not limited to, other titanium alloys, stainless steel, cobalt-nickel alloy, polypropylene, acetyl homopolymer, acetyl copolymer, other alloys or polymers, or any other biocompatible (e.g., bio-absorbable) material having adequate physical and mechanical properties to function as the stent portion of the branch member100, as described herein. The stent portion of the branch member100may therefore be self-expanding and/or may be balloon expandable. That is, in various examples, the branch member100may be transitionable between a collapsed delivery configuration and an expanded deployed configuration.

In certain instances, the branch member100may be a stent that is partially covered with a graft material. The graft material of the branch member100may further include a graft material disposed thereabout (e.g., such as about an interior of or an exterior of the branch member100). In various embodiments, graft materials can include, for example, expanded polytetrafluoroethylene (ePTFE), polyester, polyurethane, fluoropolymers, such as perfluoroelastomers and the like, polytetrafluoroethylene, silicones, urethanes, ultra high molecular weight polyethylene, aram id fibers, and combinations thereof. Other embodiments for a graft member material can include high strength polymer fibers such as ultra-high molecular weight polyethylene fibers (e.g., Spectra®, Dyneema Purity®, etc.) or aramid fibers (e.g., Technora®, etc.). Some embodiments may comprise of a graft material only partially disposed about the branch member frame.

In certain instances, the system1000is configured such that the pump200can be removably coupled with the branch member100. In some examples, the pump200is removably coupled with the branch member100after the branch member100has been delivered and deployed within the patient's vasculature (e.g., a branch member of an implantable medical device). According to some implementations, the pump200is removable from the patient's vasculature without also requiring removal of the branch member100(e.g., such that the pump200may be replaced and/or such that removal of the system1000may be done minimally invasively).

The pump200is generally configured to drive or otherwise cause blood to flow across the pump200from an inflow side1004of the system1000to an outflow side1002of the system, such as along a direction of arrow1006. The pump mechanism (also referred to herein as a pump drive) of the pump200may be, for example, a centrifugal-action pump, an axial-action pump, or other similar device such as a worm-style drive mechanism, or impeller. The pump housing is configured to interface and engage with the branch member100. The pump200is situated within the deployed branch member100such that the pump200is operable to pump or drive blood across the pump200and into the aorta and out into the vasculature of the body. The pump200can be operated to draw blood from the left ventricle (or other heart chamber), blood across the pump200, and into the aorta and out through the vasculature of the body.

In certain instances, the system1000further includes a driveline400. The driveline400is a cable assembly that operates to electrically couple a controller500located external to the patient's anatomy with the pump200or the driveline400can be a rotating driveshaft. The driveline400may be routed through the patient's vasculature (e.g., exiting the heart through the apex of the left ventricle) and then out through the skin to where it is coupled with the controller500or to a subcutaneously implanted controller500. The controller500is a module that is configured to control the operation of the pump200. The controller500may include a batter to control operation of the pump200.

In certain instances, the driveline400may be routed through one of the left or right subclavian arteries, veins, or the left common carotid artery to a subclavian or other associated access. Alternatively, the driveline400may be routed through the descending aorta to a femoral or other associated access. In certain instances, the driveline400is associated with the retention element300, for example being routed through the retention element300or integral to the retention element300. In some examples where the driveline400is integral with the retention element300, the retention element300includes one or more connectors such that when the retention element300is coupled to the branch member100, the driveline400is electrically coupled with the pump200.

In some embodiments, the system1000may be configured to operate without the need for the driveline400, or the driveline400need not extend extracorporeally. That is, in some examples, an extracorporeal control system may be configured to both control the operation of the pump, and to power the pump wirelessly (e.g., through a transcutaneous energy transmission system). In some examples, transcutaneous energy transmission may be accomplished through known means of transcutaneous energy transmission, such as those described in U.S. Pat. No. 6,400,991. Such a configuration eliminates the need to route the driveline400through the vasculature and out through a percutaneous access site, which can help minimize a risk for infection. In instances where the system1000is arranged trans-apically, the driveline400may not exit the patient through the thoracic cavity. In some examples, the driveline400may be configured to be unplugged or decoupled from the pump200at its junction with the pump200. In some examples, decoupling the driveline400from the pump200includes decoupling or removing the retention element300. In some examples, the system1000may include an “antenna” (or internal coil) that is configured for transcutaneous energy transfer (“TET”). In some examples, an extracorporeal TET component maybe worn around the torso similar to a standard heart rate monitor, and additionally coupled to a power source (wall unit or high capacity battery) such that the extracorporeal TET component is operable to transmit energy transcutaneously to the antenna.

As noted above, system1000may be incorporated into a branch member configured to interface with an access site of a main body of an implantable medical device. The main body and branch member (include the system1000) may be compacted or collapsed to the delivery state prior to deployment with the main body of the implantable medical device as shown in further detail below.

The system1000may be used as an implantable medical device for cardiac assistance as shown inFIG.2. The system1000may be included with a main body208portion of an implantable medical device or with a branch member100that is coupled or joined to the main body208as discussed in further detail below. The implantable medical device is shown implanted in a patient's aorta204leading from a patient's heart202. The patient's heart202is a simplified diagram and includes the aortic valve206, the right atrium (RA), left atrium (LA), right ventricle (RV), and left ventricle (LV).

In certain instances, the implantable medical device includes a main body208configured to deploy within the aorta204. The main body208includes a lumen maintaining fluid flow through the aorta204. In addition, the main body208also includes an access site210in a sidewall of the main body208providing access to the lumen of the main body208. The access site210may be a fenestration created before or after implantation of the main body208. In addition, the main body208may include radiopaque markers arranged near adjacent the access site210to facilitate deployment. Further, the access site210may be deployed as facing away from the brachiocephalic, subclavian, and carotid arteries. The main body208may include a curvature or conform to a curvature of the aorta with the access site210being arranged opposite the curvature and thus be arranged as facing away from the brachiocephalic, subclavian, and carotid arteries.

The implantable medical device may also include a branch member100configured to deploy within the access site210to fluidly connect with the lumen of the main body208. The branch member100may include a pump200configured to convey (or force) blood flow through the branch member100and into the lumen of the main body208. The branch member100and pump200may include the structural and functional components described above with reference to system1000. In addition and as noted above, the pump200may be configured to increase blood flow into the aorta204for cardiac assistance. In certain instances, the pump200may be integrated into the main body208. In these instances, the main body208may lack an access site210and the pump200may increase blood flow within the aorta204.

As shown inFIG.2, the branch member100extends between the aorta204and the LA (e.g., forming an anastomosis between the two structures). In certain instances, the branch member100may be configured to implant within the RA or LV and connect to the main body208in the aorta204. Implanting the branch member100in the LA may facilitate heart failure patients having preserved ejection fraction. The branch member100and main body208may function as a cardiac assist device with the pump200forcing blood from one or more chambers of the heart into the aorta204. The branch member100, main body208, and pump200may be used to assist heart function for patients' having weakened hearts or heart failure.

As noted above, to facilitate coupling of the branch member100and the main body208, the access site210of the main body208fluidly connects with the lumen of the main body208. The access site210in the main body208may include a fenestration or a portal as discussed in further detail below with reference toFIG.4andFIG.5. To deliver the branch member100and connect the aorta204and the LA, a puncturing device (e.g., arranged through the access site210) creates a small access site in a tissue wall of the aorta204and the LA. The branch member100, for example, may include stent-and graft components (as noted above with reference toFIG.1) that allow for flexibility and relative motion between the aorta204and the LA (or LV). In certain instances, the branch member100is configured to couple the atrium (LA OR RA) and the aorta2014and allow independent motion of the atrium (LA OR RA) and the aorta204.

In addition, the branch member100and pump200combination provides direct increase of blood flow for cardiac assistance. Further, the branch member100and pump200preserves space within the LA (or LV) to facilitate natural pumping of the heart202, avoid interfering with valves of the heart202, and enable transcatheter implantation. The pump200may be configured to deliver the blood flow through the branch member100and into the lumen of the main body208parallel to natural blood flow through the aorta204. As discussed in further detail below, the branch member100and pump200may be collapsed to a delivery configuration of transcatheter delivery. Having the main body208arranged in the aorta204mitigates the risk of aortic dissection, protects the aortic wall from an increased fluid flow from the pump200, and may reduce risk of device deployment.

In addition and as noted above with reference toFIG.1, the pump200may be removably coupled to the branch member100. The pump200may be delivered with the branch member100or delivered separately after the branch member100is fluidically coupled to the main body208. The pump200may anchor within the branch member100. The pump200, for example, may have retractable anchors that extend after the pump200is forced from a delivery sheath as shown in further detail with reference toFIG.9. In the event that the pump200is replaced or removed, the anchors may retract inwardly from the branch member100as the branch member100is withdrawn into the delivery sheath. The branch member100may have a collar or that interfaces with the pump200. In other instances, the pump200and the branch member100may be correspondingly keyed to fix the pump200and the branch member100. The keying may occur by rotation of the pump200within a deployed branch member100.

As noted above, the main body208may be arranged within the aorta204and more specifically the ascending aorta. The main body208may protect the aorta204from the pump200shifting or shearing. In addition, the main body208may minimize tissue overgrowth near the pump200outlet and facilitate retrieval of the pump200.

FIG.3Ais an illustration of a delivery sheath314and a branch member100of an implantable medical device for cardiac assistance in a first configuration, according to some embodiments. The delivery sheath314may be used to facilitate delivery (e.g., along with a guidewire and/or delivery catheter) of the branch member100to connect the aorta and the left atrium (or left ventricle). As shown inFIG.3A, the branch member100is collapsed or constrained within the delivery sheath314. The branch member100may include a sealing element316near or at an end of the branch member100that is configured to engage a tissue wall of the atrium or the left ventricle.

As shown inFIG.3B, the sealing element316deploys when the branch member100is deployed from the delivery sheath314. The sealing element316may be collapsed against an exterior surface of the branch member100in the delivery sheath314and extend outwardly after the branch member100is deployed. In certain instances, the sealing element316may be arranged on both ends of the branch member100with one of the sealing elements316being configured to dock and seal the branch member100within a fenestration of a main body (as shown above with reference toFIG.2) and the other of the sealing elements316being configured to arrange and secure the branch member100to a tissue wall of the heart.

FIG.4is an illustration of a branch member100of an implantable medical device arranged within a portal418, according to some embodiments. The portal418may be arranged within a main body208of an implantable medical device for ventricular assist (e.g., as shown inFIG.2). The portal418may be aligned with an access site210in the main body208and the branch member100may be configured to implant within the portal418to fluidly connect the branch member100and the main body208.

In certain instances, portal418includes a support wall and secondary lumen having a first longitudinal orientation will therefore define a blood flow direction of the branch member100that is aligned with the blood flow direction of the main body208. The support wall of the portal418may include a stent and a graft component. Further details on internal support walls for supporting branch members extending through access sites in the main body are disclosed in U.S. Pat. No. 6,645,242 to Quinn.

FIG.5is an illustration of a branch member100and flange520, according to some embodiments. The flange520may be configured to engage a tissue wall522in a fluid tight fluid engagement between the branch member100and atrium or ventricle into which the branch member100is arranged. The flange520prevents leakage between the puncture made in the atrium or ventricle and the branch member100.

The flange520may be integrated with the branch member100or separately deployed and anchored with the branch member100. In certain instances, the flange520may be balloon expandable to deploy about the tissue wall522. The flange520may extend and flatten out around the tissue wall522after balloon or self-expansion after deployment from a delivery sheath314as discussed in detail above. The flange520may include a stent and/or a graft portion or may include a polymeric material.

FIG.6is an illustration of another implantable medical device for cardiac assistance, according to some embodiments. The implantable medical device is shown implanted in a patient's aorta204leading from a patient's heart202. The patient's heart202is a simplified diagram and includes the aortic valve206, the right atrium (RA), left atrium (LA), right ventricle (RV), and left ventricle (LV).

In certain instances, the implantable medical device includes a main body208configured to deploy within the aorta204. The main body208includes a lumen maintaining fluid flow through the aorta204. In addition, the main body208also includes a portal418coupled to the main body208providing access to the lumen of the main body208. The implantable medical device may also include a branch member100configured to deploy within the portal418to fluidly connect with the lumen of the main body208. The branch member100may include a pump200configured to convey blood through the branch member100and into the lumen of the main body208. The branch member100and pump200may include the structural and functional components described above with reference to system1000. In addition and as noted above, the pump200is configured to increase blood flow into the aorta204for cardiac assistance. In certain instances, the pump200may be integrated into the main body208. In these instances, the main body208may lack an access site210and the pump200may increase blood flow within the aorta204.

In addition, the branch member100may be configured to be disposed within the aorta adjacent or across the aortic valve208or between leaflets of the valve206. The branch member100may be configured to allow the aortic valve208to close about the branch member100to avoid backflow or leakage while utilized the pump200may increase blood flow within the aorta204. In certain instances, the branch member100includes a cannula624that extends from end of the branch member100with the cannula624being arranged within the aortic valve208.

FIG.7is an illustration of an example delivery system for an implantable medical device for cardiac assistance, according to some embodiments. The delivery system is shown utilizing both trans-apical access and trans-femoral access sites, which allows delivery of an implantable medical device with a branch member inside of the heart through manipulation of at least two portions or members of the delivery system from outside of the body from the respective trans-apical and trans-femoral access sites. As discussed in further detail below, the delivery system of the present disclosure is transcatheter-based and avoids open heart surgery that may be required for prior cardiac assistance devices.

The delivery system can, for example, be used to deploy an implantable medical device, such as a main body208for placement in the ascending portion of the aortic. A guidewire1206can be inserted through the trans-apical access site and into the left ventricle1010of the heart1100, as shown inFIG.10. The guidewire1206can be routed through the aortic valve1012, the aorta1014, a femoral artery of one of the legs, and out of the body via the trans-femoral access site (not shown), resulting in a “body floss” or “through-and-through” access configuration, wherein opposite terminal ends1205,1207of the guidewire1206extend outside of the body from respective trans-apical and trans-femoral access sites1102,1104.

A first catheter, generally indicated at1300, includes a leading end1306and an opposite trailing end1322. The first catheter1300has a guidewire lumen1310through which the guidewire1206can be routed. A first end1205of the guidewire1206can be inserted into the guidewire lumen1310at the leading end1306of the first catheter1300. The leading end1306of the first catheter1300can be fed into the vasculature through the trans-apical access site1102via the first introducer sheath1202. The first catheter1300can then be pushed along the guidewire1206in the direction indicated at1302until the leading end1306exits the trans-femoral access site (not illustrated). The trailing end1322of the first catheter1300remains outside of the body and extends from the first access site1102via the first introducer sheath1202. In this configuration, the catheter1300can be maneuvered by pushing or pulling the leading end1306and the trailing end1322of the first catheter1300from outside of the body.

A second catheter, generally indicated at1400, includes a leading end1406and an opposite trailing end1422. The second catheter1400has a guidewire lumen1410for receiving the guidewire1206therethrough. The second end1207of the guidewire1206can be inserted into the guidewire lumen1410at the leading end1406of the second catheter1400. The second catheter1400can be pushed along the guidewire1206until the leading ends306,306engage. Although shown with guidewires1206, the catheters1300,1400may be used within guidewires1206in certain instances.

The leading ends1306,1406of the first and second catheters1300,1400can be configured for matingly engaging or coupling to each other. Further, the leading ends1306,1406can be configured for releasably coupling to each other. The leading ends1306,1406of the first and second catheters1300,1400can be coupled to each other extra corporeal or in situ. Once the leading ends1306,1406are coupled, the trailing ends1322,1422of the first and second catheters1300,1400can be accessed outside of the body from the respective trans-apical access site1102and trans-femoral access site1104and pushed, pulled and rotated to axially and rotatably position a main body portion208of the implantable medical device at the treatment site.

The main body portion208can be releasably maintained or radially compressed toward a delivery configuration for endoluminal delivery by any suitable constraining means, such as a film constraining sleeve, a constraining tether or lattice, retractable sheath and the like as shown inFIG.7. Optionally, one or more constraining means or combination of constraining means can be configured to allow staged expansion through one or more intermediate expanded states leading to full deployment. The branch member100(not shown) may be similarly constrained.

Other surgical tools may be delivered through a third access point to the aorta through one of the major branch arteries along the aorta in connection with the deployment of the device at or in the heart or along the aorta. For example, a filter may be deployed to filter blood entering the branch arteries1016,1018,1020.

The catheters1300,1400may also deliver the main body208and the branch member100from femoral vein with trans-septal puncture or from apex of heart (trans apical puncture and through mitral up through aorta) or on the ventricle side as well. In certain instances, the main body208is delivery through the femoral artery and the branch is delivery from the femoral artery or vein.

In delivery the branch member100across the aorta1014and into the atrium or ventricle, one or both of the catheters1300,1400may include a puncturing device that creates access sites in the tissue wall of the aorta1014and the atrium or ventricle. In addition, one or both of the catheters1300,1400may include a delivery sheath (as noted above) that is pressed against the tissue when and after the access sites are created. Magnets or other coupling members in the delivery sheaths of the catheters1300,1400may attach together for deployment of the branch member100.

The catheters1300,1400may be used to deploy the main body208in the aorta1014and the branch member100across the aorta1014and into the atrium or ventricle. More specifically, the first catheter1300may deploy the main body208and the second catheter1400may deploy the branch member100. In other instances, the main body208can be deployed in the aorta1014and the branch member100can be deployed across the aorta1014and into the atrium or ventricle by using one of the catheters1300,1400with a trans-septal approach (across atrial septum into the left atrium) and the other of the catheters1300,1400using a femoral approach.

FIG.8Ais an illustration of a branch member according to some embodiments.FIG.8Bis an illustration of a pump, according to some embodiments.FIG.8Cis a cross sectional view of the branch member shown inFIG.8C, taken along line8A-8A.FIG.8Dis a cross sectional view of the pump shown inFIG.8B, taken along line8B-8B.

With reference now toFIG.8A, the branch member100generally includes a stent body102defining an exterior104and an interior106. The stent body102may be generally cylindrically shaped and configured to adopt a profile consistent with the vasculature within which is it deployed and expanded. In some examples, the stent body102is defined by a plurality of interconnected strut elements108or helically wound strut elements108.

For example, as shown inFIG.8B, the pump200, arranged within at least a portion of the branch member100or extending from the branch member100, generally includes a pump housing840and a pump drive element212. The pump housing840generally defines an exterior846and an interior844. The exterior846of the pump housing840is configured to engage and interface with the interior106of the branch member100such that the pump200can be coupled with the branch member100. The interior844of the pump housing840is configured to house or accommodate the pump drive element212such that the pump drive element212can move relative to the pump housing840to cause blood to flow through the pump200. In some examples, blood travels through the pump200within an annular space848that is defined between the pump drive element212and the pump housing840, although other pump configurations are contemplated and fall within the scope of the present disclosure provided that the pump housing can be configured to interface and engage with the branch member100. Thus, although the pump drive element212shown inFIG.8Bincludes a worm drive having a helical flange extending about a central shaft (e.g., an impeller configuration), the application should not be understood to be limited to such configuration, but should instead be understood to be operable with other pump drive configurations.

As mentioned above, in various embodiments, the pump200is receivable within the branch member100. As shown inFIGS.8C and8D, the each of the pump200and the branch member100include complementary features that facilitate the coupling of the branch member100with the pump200.

As shown inFIG.8C, the branch member100includes a plurality of pump locating features108a,108b, and108c. In this illustrated example, the pump locating features108a-108care channels or recesses that extend longitudinally along a longitudinal axis of the branch member100. In some examples, the pump locating features108a-108cextend parallel to the longitudinal axis of the branch member100. In some examples, one or more of the pump locating features108a-108cextend along less than all of the length of the branch member100. That is, in some examples, the pump locating features108a-108cextend only partially between the first end112and the second end114of the branch member100. In some such examples, one or more of the pump locating features108a-108cterminates at a location between the first and second ends112and114. This termination of the one or more channels or recesses of the pump locating features108a-108coperates as an abutment against which the pump housing840of the pump200can sit.

As explained further below, such a configuration provides that the pump housing840of the pump200may only be inserted into and removed from the branch member100in a unidirectional manner. For instance, when inserted into the branch member100, the pump200can be advance longitudinally along the branch member100until the pump housing840engages the termination point of the one or more channels or recesses of the pump locating features108a-108c. Moreover, when being removed from the branch member100, the pump200can only be withdrawn in a direction opposite from that direction in which the pump200was advanced when it was coupled to the branch member100. Securing the pump200within the branch member100in such a manner operates to prevent the pump200from being drawn through the branch member100.

As mentioned above, the pump housing840generally includes one or more features that are complimentary of the pump locating features108a-108cof the branch member100. With reference now toFIG.8D, the pump housing840is shown as including a plurality of stent engagement elements216a,216b, and216c. As shown, the stent engagement elements216a-216care features that protrude from the exterior of the pump housing840. The stent engagement elements216a-216cextend longitudinally along the exterior846of the pump housing840, such as parallel to a longitudinal axis of the pump housing840. In some examples, the stent engagement elements216a-216cextend between the first end218and the second end220of the pump housing840. In some examples, one or more of the stent engagement elements216a-216cmay extend beyond (or alternatively short of) one or more of the first and second ends218and220of the pump housing840. The stent engagement elements216a-216care generally complimentary in shape, size, and location and orientation of the pump locating features108a-108csuch that the stent engagement elements216a-216ccan be received within the pump locating features108a-108c.

As shown inFIGS.8C and8D, the stent engagement elements216a-216care formed as positive dovetail features while the pump locating features108a-108care formed as the complimentary negative dovetail features. Additionally, the stent engagement elements216a-216care shown as being evenly distributed circumferentially about the exterior846of the pump housing840, while the pump locating features108a-108care similarly evenly distributed circumferentially about the interior106of the branch member100.

It is to be appreciated that the interaction between the stent engagement elements216a-216cand the pump locating features108a-108coperates to help locate the pump200within the branch member100. For instance, the engagement between stent engagement elements216a-216cand the pump locating features108a-108c(the combination of which are referred to herein as alignment features) helps to align the pump200longitudinally with respect to the branch member100. Likewise, the engagement between stent engagement elements216a-216cand the pump locating features108a-108chelps to align the pump200coaxially with the branch member100.

Additionally, in various examples, this interaction also operates to prevent pitch/yaw/roll (e.g., rotation relative to the longitudinal axis of the branch member100) of the pump housing840relative to the branch member100during operation of the system1000, which provides the constraint necessary to allow the pump200to operate to drive blood flow across the pump200(e.g., the pump drive element212can rotate or be rotated relative to the pump housing840without the pump housing840also rotating).

In various examples, with the pump200properly aligned and seated within the branch member100, the pump housing840and the branch member100form a seal therebetween such that blood cannot flow between the pump housing840and the branch member100. In some examples, the pump housing840is suspended within the branch member100such that blood can flow either through/across the pump drive element842, or around the pump housing840. Such a configuration allows for blood flow around the pump in the case of a pump failure, and additionally provides favorable hemodynamics with regard to hem olysis and perfusion of the coronary arteries. In some examples, bypass blood flow (e.g., blood flow around the pump200may be facilitated by the branch member100, itself. For instance, in some examples, the branch member100may include an open celled stent structure, wherein the pump200is positioned within or suspended by the open celled stent branch member, which allows for blood to flow through and around the pump200(e.g., through the open cells of the stent branch member.

It is also to be appreciated that while the branch member100and the pump200shown inFIGS.8C and8Dinclude complementary alignment features that are in the shape of dovetails, various other sizes and shapes of such features are envisioned and can be implemented without departing from the spirit or scope of the present disclosure. For example, the dovetail geometry may be replaced with one or more of various alternative geometries, including but not limited to, triangles, squares, and polygons. Similarly, though theFIGS.8C and8Dshow three evenly distributed (e.g., positioned120degrees away from each other) alignment features (e.g., stent engagement elements216a-216cand pump locating features108a-108c), as little as one or two such alignment features may be used, or more than three such alignment features may be used. Likewise, where more than one alignment feature is used, such alignment features need not be evenly distributed about the interior/exterior of the branch member100and the pump housing840.

It should also be appreciated that while the alignment features shown inFIGS.8C and8Dextend longitudinally along the branch member100and the pump housing840, the alignment features may alternatively be arranged in a helical pattern. In such an alternative configuration, the pump200is coupleable with the branch member100by aligning the helical alignment features of the pump200and the branch member100with one another and then rotating the pump200and the branch member100relative to one another, such as about the longitudinal axis of the branch member100, for example.

It should also be appreciated that while the branch member100and the pump200shown inFIGS.8C and8Dare shown with the alignment features protruding from the exterior846of the pump housing840and as channels or recesses along the interior106of the branch member100, in some other examples, the alignment features may protrude from the interior106of the branch member100and be formed as recesses or channels along the exterior846of the pump housing840. Alternatively, the branch member100and the pump housing840may each include a combination of alignment features that protrude therefrom and that are formed as recesses or channels therein.

FIG.9shown a variety of additional configurations for the various components (e.g., the branch member100, the pump200, the retention element300, and the driveline400) of the systems disclosed herein. For instance, in some examples, the branch member100may include one or more support components (e.g., components “a” and “b”) that project radially inwardly and are configured to interface with and support the pump200within the branch member100, as shown. In some examples, the pump200may include one or more features that are complementary of the support components “a” and “b” of the branch member100, and that engage therewith to couple the pump200to the branch member100, such that the pump200is suspended within an interior of the branch member100(e.g., within a lumen defined by an interior of the branch member100). As shown, the pump200is coaxially aligned with the branch member100, wherein an exterior of the pump200is offset from an interior of the branch member100such that an annular void is defined between the interior of the branch member100and the pump200. In various examples, blood is operable to flow through such an annular void (e.g., in conjunction with, or as an alternative to blood flow through the pump200).

FIG.10is an illustration of an example branch member100with flanges520a,520b, according to some embodiments. The branch member100creates a fluidic connection between spaces or tissue structures such as the aorta and an atrium or ventricle as discussed in detail above. As shown, the branch member100includes flanges520a,520b. The flanges520a,520bmay be arranged to seal the branch member100within tissue structures or within a main body208of an implantable medical device as discussed above. In instances where the branch member100includes two flanges520a,520bas shown, the main body208includes a fenestration (either created after implantable or prior to implantation).

The branch member100includes a lumen46that extends longitudinally from a first end of the branch member100to a second end of the device40. The lumen46acts as a connection (e.g., a shunt passageway) between the main body208, implanted in the aorta, and the internal intestinal space of the heart (e.g., atrium or ventricle), such that the main body208is in fluid communication with the atrium or ventricle via the anastomosis device branch member100. The flange520bmay be configured to contact a tissue wall522as described in detail above. A wall44of the lumen46may be sized to interference fit with a pump200.

FIG.11is an illustration of another implantable medical device for cardiac assistance, according to some embodiments. The implantable medical device is shown implanted in a patient's aorta204, and more particularly within the descending aorta204, leading from a patient's heart202. The patient's heart202is represented as a simplified diagram and includes the aortic valve206, the right atrium (RA), left atrium (LA), right ventricle (RV), and left ventricle (LV).

In certain instances, the implantable medical device includes a main body208configured to deploy within the aorta204. The main body208includes a lumen maintaining fluid flow through the aorta204. In addition, the main body208also includes a portal coupled to the main body208providing access to the lumen of the main body208. The implantable medical device may also include a branch member100configured to deploy within the fenestration or portal (as described, respectively, above with reference toFIGS.2and6) to fluidly connect with the lumen of the main body208. Though shown coupled to the branch member100, in certain instances, the pump200may be integrated into, or otherwise coupled with the main body208.

As referenced above, the branch member100may include a pump200configured to convey blood through the branch member100and into the lumen of the main body208. The branch member100and pump200may include the structural and functional components described above with reference to system1000. In addition and as noted above, the pump200is configured to increase blood flow into the aorta204for cardiac assistance.

As shown inFIG.11, the pump200and/or branch member100may be arranged within a left atrial appendage (LAA) of the heart202. The branch member100may exit the LAA to couple to the main body208arranged within the descending aorta204. The main body208may be arranged within other portions of the aorta204. In certain instances, the pump200and branch member100include a sealing element316or flange (e.g., as shown inFIG.3B) to secure and position the pump200and branch member100within the LAA. In other instances, a stent structure1120may be coupled to the branch member100and/or pump200.

In certain instances and as shown, the stent structure1120may contact interior walls of the LAA. The stent structure1120, as shown in further detail inFIG.12, may stabilize the pump200and/or branch member100within the LAA. The stent structure1120may be configured to conform to the shape of the LAA (e.g., including an acorn or tapered shape). In addition, the stent structure1120may be at least partially covered by a membrane to seal off the LAA about the pump200and/or branch member100. The stent structure1120may include a central eyelet through which the pump200and/or branch member100are arranged. Further, the stent structure1120, which may include the membrane, lessens turbulent blood flow across the LAA to minimize the opportunity for thrombus formation. For further discussion and detail regarding some suitable designs for the stent structure1120, reference may be made to U.S. Patent Publication No. 2016/0331382 to Center et al, U.S. Pat. No. 9,554,806 to Larsen et al, and U.S. Patent Publication No. 2015/0005810 to Center et al, which discuss left atrial appendage medical devices.

In certain instances, the pump200may be coupled to a driveline400that is coupled to a controller configured to control the operation of the pump200. As shown inFIG.1, the driveline400may be routed through the heart202septum to the right atrium and through the vena cava.

In certain instances, the branch member100may include a portion that is arranged directly within the aorta204without the main body208. In certain instances, the branch member100includes a first end portion configured to deploy within the left atrial appendage of a heart and a second end portion configured to deploy within the aorta204. The branch member100, as discussed in detail above, is configured to interface with the pump200to pass blood flow through a lumen of the branch member100from the left atrial appendage into the aorta204. The branch member100may include a flange configured to engage a tissue wall of the aorta (e.g., as shown inFIG.5andFIG.10). The flange may be configured to engage the tissue wall in a fluid tight fluid communication between the branch member100and the tissue wall of the aorta204.

In certain instances, the branch member100(or pump200) may be anastomosed to the aorta204(e.g., using flanges). The pump200may be configured to intake blood from the left atrial appendage and discharge the blood into the aorta204. When the branch member100is directly coupled to the aorta204, the outflow of the pump200is directly to the aorta204through the branch member100.

FIG.12is an illustration of another implantable medical device for cardiac assistance arranged within a left atrial appendage and including a stent structure1120, according to some embodiments. As shown, the pump200and branch member100is arranged through the stent structure1120. The stent structure1120may include an occlusive face that is arranged near an ostium1222of the left atrial appendage. In addition and as shown, the stent structure1120includes frame components1226and a membrane1224covering the frame components.

FIG.13is an illustration of an example implantable medical device for cardiac assistance, according to some embodiments. The system1000may be used as an implantable medical device for cardiac assistance as shown inFIG.13. As shown inFIG.13, a main body208portion of an implantable medical device is arranged within a patient's aorta204leading from a patient's heart202. The patient's heart202.

The main body208includes a lumen maintaining fluid flow through the aorta204. In addition, the main body208also includes an access site210in a sidewall of the main body208providing access to the lumen of the main body208. The access site210may be a fenestration created before or after implantation of the main body208. In addition, the main body208may include radiopaque markers arranged near adjacent the access site210to facilitate deployment. Further, the access site210may be deployed as facing away from the brachiocephalic, subclavian, and carotid arteries. The main body208may include a curvature or conform to a curvature of the aorta with the access site210being arranged opposite the curvature and thus be arranged as facing away from the brachiocephalic, subclavian, and carotid arteries.

The implantable medical device may also include a branch member100configured to deploy within the access site210to fluidly connect with the lumen of the main body208. As noted above, to facilitate coupling of the branch member100and the main body208, the access site210of the main body208fluidly connects with the lumen of the main body208. The access site210in the main body208may include a fenestration or a portal.

As shown inFIG.13, the branch member100is arranged external to the heart202. In certain instances, the branch member100is arranged about a patient's heart202. The implantable medical device may also include a pump200arranged within a chamber of the heart202that is configured to convey blood through the branch member100and into the lumen of the main body208. In certain instances, the pump200is configured to be disposed within a left ventricle of the patient's heart202and convey blood through the branch member100and into the lumen of the main body208.

Implanting the branch member100to connect the pump200to the main body208in the aorta may function as a cardiac assist device with the pump200forcing blood from one or more chambers of the heart into the aorta204. The branch member100, main body208, and pump200may be used to assist heart function for patients' having weakened hearts or heart failure. In addition and as noted above, the pump200may be configured to increase blood flow into the aorta204for cardiac assistance.

To deliver the branch member100and connect the aorta204and the pump200, a puncturing device (e.g., arranged through the access site210) creates a small access site in a tissue wall of the aorta204. The branch member100may be arranged within the access site210after puncturing the aorta204(which may then be sealed (e.g., the main body208seals within and external to the aorta204by having an overlap between the branch member100and the access site210). The branch member100, for example, may include stent-and graft components (as noted above with reference toFIG.1) that allow for flexibility and relative motion between the aorta204and the pump200.

In addition, the branch member100and pump200combination provides direct increase of blood flow for cardiac assistance. The branch member100and pump200may be configured to deliver the blood flow through the branch member100and into the lumen of the main body208parallel to native blood flow through the aorta204. The branch member100, the main body208, and the pump200may be collapsed to a delivery configuration of transcatheter delivery. Having the main body208arranged in the aorta204mitigates the risk of aortic dissection, protects the aortic wall from an increased fluid flow from the pump200, and may reduce risk of device deployment

Arranging the main body208and the branch member100and pump200in this manner facilitates connection of a pump200to the aorta204without an additional open heart procedure. The main body208and the branch member100and pump200may be sutureless, percutaneous, and anastomotic. The main body208and the branch member100and pump200may also provide in-line (or parallel) flow that can reduce shear and turbulence which could damage the blood or consume blood proteins, and potentially reduces back-pressure on the heart. The main body208and the branch member100and pump200may also protects the aorta locally from shear-induced damage (e.g., dissection, intimal hyperplasia) and/or decouples the motion of the heart from the motion of the aorta204, allowing native motion while minimizing the risk of erosion or pull-out. In certain instances, the branch member100may be arranged directly within the aorta204without the main body208.

FIG.14is an illustration of an example implantable medical device for cardiac assistance for implantation into a pulmonary vein, according to some embodiments. The implantable medical device may be a pump200, or in other instances, the implantable medical device may be a pump200that deploys within a main body that may include a stent, graft, or stent-graft combination for implantation into a vessel of a patient. In certain instances, the implantable medical device is configured to deploy within a pulmonary vein350and the implantable medical device includes a lumen maintaining fluid flow through the pulmonary vein350. In certain instances, the pump200may be arranged within the vena cava (inferior or superior) to facilitate right ventricular assistance. The pump200may be arranged within a branch member100in certain instances and arranged within the vena cava. In other instances, the pump200(with or without the branch member100) may be arranged within the descending or thoracic aorta, or peripheral vessels to facilitate blood flow. In addition, the pump200(with or without the branch member100) may increase flow of other non-blood bodily fluids when placed in other areas of the body (e.g., urinary, biliary).

The implantable medical device may also include a pump200arranged within the main body of the implantable medical device that is configured to convey blood through the lumen of the main body. In certain instances, the pump200is configured to intake blood flow into the left atrium352. In addition, the pump200may be configured to increase flow out of the pulmonary vein350to increase cardiac output.

In certain instances, the pump200includes a driveline400configured to power the pump200. The driveline400may be coupled to the pump200and arranged out of the pulmonary vein350into the left atrium352and across a septum to exit a right side of the heart. In certain instances, the driveline400exits a patient via an iliac vein. The pump200may facilitate direct filing of the ventricles when the pump200is implanted in the pulmonary vein350. The pump200being implanted into the pulmonary vein350may facilitate increased pulmonary circulation, decrease risk of chronic obstructive pulmonary disease (COPD), increase cardiac output, and implant a cardiac assistance device using venous access, which can reduce access site complications as compared to arterial access.

In certain instances, the pump200may be used to facilitate flow within another vessel. The pump200may be implanted for vessel-vessel communication (e.g., percutaneous fistula creation). In addition, the pump200may include or be coupled to a drug delivery reservoir with the pump200pumping blood and a therapeutic drug within a patient. In other instances, the pump200may include a sensor used to sample blood within a patient. In addition, the sensor may be incorporated with the pump to measure blood flow and indicate the flow to a physician for monitoring.

FIG.15is an illustration of an example implantable medical device for cardiac assistance, according to some embodiments. As shown inFIG.15, a pump200is arranged between a patient's aorta204and a patient's heart202. The pump200, in certain instances, is arranged in the left atrium, right atrium or left ventricle. The pump200is configured to force blood flow from the heart chamber into the aorta204.

To seal the pump200in the heart202and the aorta204, a conduit of native tissue460about the pump and between the aorta and the heart chamber. In certain instances, the conduit of native tissue460may be formed by creating or tissue ingrowth to form a tissue layer between the aorta204and the heart202. The pump200may include a material arranged about an outer surface of the pump200that configured to facilitate tissue ingrowth. In certain instances, the material includes at least one of Dacron and ePTFE

The material may be a graft or covering component that can have a microporous structure that provides a tissue ingrowth scaffold. In certain instances, the covering component may include a fluoropolymer, such as an expanded polytetrafluoroethylene (ePTFE) polymer. In some examples, the covering component can be a membranous covering. In some examples the covering component can be a film. The covering component may be modified with covalently attached heparin or impregnated with one or more drug substances that are released in situ to promote wound healing. In some instances, the drug may be a corticosteroid, a human growth factor, an anti-mitotic agent, an antithrombotic agent, or dexamethasone sodium phosphate.

After the conduit of native tissue460is formed, the pump200may be removed. In certain instances, the conduit of native tissue460may be relined with another material (e.g., a membrane or graft material) after the conduit of native tissue460is formed.

FIG.16Ais a top view of an example implantable medical device for cardiac assistance for implantation as a heart valve, according to some embodiments.FIG.16Bis an illustration of the example implantable medical device shown inFIG.16Aarranged as a heart valve, according to some embodiments. The implantable medical device is a heart valve device that includes a support frame560. A plurality of leaflets562a-care coupled to the support frame560. The plurality of leaflets562a-care configured to open to allow forward flow therethrough and to occlude the support frame560to prevent retrograde flow. A pump200may also be arranged with the support frame560. The pump200may be configured to force blood through the support frame560.

In certain instances and as shown inFIG.16B, the plurality of leaflets562a-care configured to coapt about the pump200arranged within the support frame560. The pump200may be arranged centrally within the support frame560, with the leaflets562a-cclosing onto the pump200. The prosthetic valve (the support frame560and the leaflets562a-c) and the pump200may configured to transcatheter delivery. In certain instances, the prosthetic valve is configured to replace an aortic valve of a patient and in other instances, the prosthetic valve is configured to replace a mitral valve of a patient.

In certain instances, a filter564may be arranged on an outflow end of the support frame560. More specifically, the filter564may be arranged at the outflow end of the pump200. The filter564may facilitate protection against emboli passing through the support frame560.

A method of delivering the support frame560and pump200via a catheter can comprise providing a delivery catheter having an expandable support frame560in a collapsed state constrained over or within the delivery catheter at a distal end of the delivery catheter; passing the delivery catheter through the introducer sheath and into valve annulus; positioning the distal end of the delivery catheter so that the support frame560is properly positioned and oriented within the valve annulus; and expanding the support frame560at the valve annulus into contact therewith.

FIG.17is an illustration of an example implantable medical device600for cardiac assistance, according to some embodiments. System1000may form a portion of the implantable medical device600for cardiac assistance shown inFIG.17. For example, the implantable medical device600includes a main body208portion that is configured to be deployed within a patient's aorta leading from a patient's heart. The implantable medical device600may also include a branch member100extending from the main body208and configured to deploy within a chamber of the heart to fluidly connect the aorta and the chamber of the heart. In certain instances, the branch member100may be integral with the main body208. The branch member100may extend from an end portion of the main body208(as shown inFIG.17) or the branch member100may extend from circumferentially from the main body208.

The branch member100being integral with or forming a portion of the main body208may facilitate deployment of the main body208and the branch member100from same deployment location, direction, or using the same catheter device. In certain instances, the main body208may be arranged within the aorta via the femoral artery and into the aorta. After deploying the main body208, punctures may be made in the aorta and a chamber of the heart (atrium or ventricle) via the same femoral access. In certain instances, a guidewire used to deploy the main body208may be used to puncture tissue in the aorta and the chamber of the heart. Immediately after puncturing the aorta and the chamber of the heart, the branch member100may cross the aorta and the chamber of the heart. In certain instances, puncture and delivery of the branch member100may occur in the same action (e.g., using the same guidewire). Thus, leakage may be minimized by deploying the branch member100in an immediately sequence. In addition, the deployment and puncturing may occur using a singular delivery handle/system.

The implantable medical device600may also include a pump200(not shown). As discussed in detail above, the pump200may be arranged within the branch member100and configured to force blood flow from the chamber of the heart through the branch member100and into the lumen of the main body208. To deploy the pump200, the pump200may be arranged through the inferior vena cava (IVC), across the septum of the heart and deployed with the branch member100.

The main body208and the branch member100may include stent, graft, or stent and graft components. In addition, the branch member100may be configured to telescope inwardly and outwardly relative to the main body208. In certain instances, the branch member100may collapse and extend to alter a length of the branch member100.

FIG.18is an illustration of an example branch member100, according to some embodiments. As noted above, the branch member100may be configured to interface with a pump (not shown) to pass blood flow through the branch member100into the main body. In other instances, the branch member100may a support frame used in a prosthetic valve (e.g., as shown inFIGS.16A-B). The branch member100(or support frame) may be delivered to a target location and removably couple to a pump after the branch member100has been delivered and deployed within the patient (e.g., a branch member of an implantable medical device).

In certain instances, the branch member100(or support frame) may be configured to anchor the pump within the branch member. As shown inFIG.18, for example, the branch member100(or support frame) may include an attachment mechanism702that is configured to anchor the pump with the branch member100(or support frame). In certain instances, each of the branch member100(or support frame) and the pump may include complementary attachment mechanisms702,704to anchor the pump within the branch member100. In addition and alternatively to the attachment mechanism702or complementary attachment mechanisms702,704, the branch member100(or support frame) may be configured to frictionally engage with the pump to anchor the pump within the branch member100.

FIG.19Ais an illustration of a pump200and a hinge structure302in a first configuration, according to some embodiments. The hinge structure302may be the anchor element for the pump200. In certain instances, the hinge structure302is configured to articulate a portion of the pump200and maintain the pump200in an angled configuration as shown inFIG.19B. The hinge structure302may maintain the pump200at an angle after a force is applied to alter the configuration of the pump200.

In certain instances, the pump200includes a tubular portion304and the hinge structure302is arranged circumferentially within or about the tubular portion304. In addition, the pump200may have multiple hinge structures302arranged at different positions along a length of the tubular portion304. Multiple hinge structures302may facilitate bending of the tubular portion304at different angles and/or initiate bending at different portions along a length of the tubular portion304. Bending at the hinge structure302creates fixation between the pump200and the branch member100.

The hinge structure302may include a plurality of discrete rings configured to maintain the tubular portion304in the angled configuration in response to an applied force. In certain instances, the discrete rings of the hinge structure302may be metal stent-like structures. In addition, the hinge structure302may also be formed by a corrugated portion of the tubular portion304. The tubular portion304, along with a motor and impeller as described above with reference toFIG.1, may include a stent, a stent-graft, or a graft. In certain instances, the corrugated portion of the tubular portion304may be formed of a graft material. In addition and as noted above with reference toFIG.1, the pump200may include a driveline configured to couple to a controller that drives the pump200.

The pump200may be delivered into branch member100by a catheter. The catheter may be deflected to angle the hinge structure302. In instances where the pump200is to be removed, a catheter may be routed to the branch member100, and the hinge structure302may be un-articulated. The hinge structure302may engage with a branch member100arranged in a portal or a fenestration of a main body graft. In addition, the hinge structure302may be include a shape memory material (e.g., Nitinol) such that the hinge structure302is arranged in a substantially linear configuration (e.g., as shown inFIG.19A) during delivery but shape set into an elbow or angled configuration (as shown inFIG.19B). In these instances, the hinge structure302will deploy to the angled configuration after delivery and engage the branch member100.

FIG.20is an illustration of an example pump200and anchor element406, according to some embodiments. As shown inFIG.4, the anchor element406is arranged on an external surface of the pump200. The anchor element406may be configured to expand and engage an interior surface of a branch member.

In certain instances, the anchor element406is an expandable balloon408configured to expand and engage an interior surface of the branch member. The expandable balloon408may be coupled to an inflation/deflation pump410by way of a conduit412. The inflation/deflation pump410may be arranged internal or external to the patient and the conduit412may be routed similar to the driveline. In certain instances, the expandable balloon408may be arranged circumferentially about the pump200.

In certain instances, the anchor element406is or includes spring414arranged on the external surface of the pump200. The anchor element406may also include the expandable balloon408, which is configured to collapse the spring414in response to inflation. In certain instances, the expandable balloon408may be deflated to collapse the spring and close a gap between the pump200and the branch member.

In either instance, the expandable balloon408may be inflated and deflated to reposition the pump200. In addition, the expandable balloon408creates an interference fit between the pump200and the branch member. The expandable balloon408may be filled with liquid (e.g., saline, contrast medium) or air. in addition, the expandable balloon408may be backfilled with curing fluid that solidifies if the pump200is permanently implanted within the branch member100. the curing fluid may also be dissolvable such that the pump200is not permanently implanted within the branch member100.

FIG.21is an illustration of another example pump200and anchor element406, according to some embodiments. As shown inFIG.21, the anchor element406is arranged at an end portion516of the pump200. In addition, the anchor element406includes a plurality of flanges518extending radially from the end portion516of the pump200.

The flanges518may include a self-expanding material (e.g., Nitinol) that extend radially from the end portion516of the pump200. The pump200may be arranged within a delivery sheath and the flanges518may extend after the pump200is arranged out of the delivery sheath. In certain instances, the pump200may be arranged directly between the aorta and an atrium or ventricle with the flanges518deploying within the aorta without a main graft. In these instances, the flanges518may be configured to facilitate tissue ingrowth.

FIG.22is an illustration of an example branch member100, pump200, anchor element406, and receiving structure620, according to some embodiments. As shown inFIG.22, the pump200is arranged within and engaged with the branch member100. The pump200includes the anchor element406along an external surface of the pump200and the branch member100includes the receiving structure620along an internal surface of the branch member100. The anchor element406is configured to engage the receiving structure620to removably fix the pump within the branch member. In certain instances, the anchor element406is a stent622and the receiving structure620is configured to contain the stent622to removably fix the pump200within the branch member100.

In certain instances, the stent622is self-expanding after the pump200is arranged out of a delivery sheath. In addition, the stent622may be elastic such that movement of the pump200into the branch member100overcomes friction of the and receiving structure620and nests within the receiving structure620. The receiving structure620may include end portions640,642that produced outwardly and create nesting area of the stent622.

As shown, there are more than one of each of the stent622and the receiving structure620. In certain instances, the stent622and the receiving structure620may be discrete elements about the outer circumference of the pump200and the branch member100, respectively. There may be any number of the stent622and the receiving structure620including one, two, three, four, five, or more of each of the stent622and the receiving structure620. The number of receiving structure620and the number of stents622may be unequal in number. In certain instances, there may be a greater number of receiving structures620to facilitate docking of the stents622. In other instances, one or both of the stent622and the receiving structure620are discrete elements and the other of the stent622and the receiving structure620may be continuous. In certain instances, both the stent622and the receiving structure620are continuous. In addition, the stent622may be arranged on the internal surface of the branch member100and the receiving structure620may be arranged on the external surface of the pump200.

The stent622may be spring-like and may facilitate removal of the pump200from the branch member100. The pump200may include an engagement feature628that may be snared or grasped in removing the pump200from the branch member100. After gripping or grasping the engagement feature628, the pump200may be withdrawn and the elasticity of the stent622may temporarily collapse against the pump200and move past the receiving structure620.

FIG.23is an illustration of another example branch member100, pump200, anchor element, and receiving structure, according to some embodiments. In certain instances, the anchor element is a protrusion406and the receiving structure is a shaped notch620configured to contain the protrusion406may removably fix the pump200within the branch member100. The protrusion406may be arranged with the pump200and the shaped notch620may be arranged with the branch member100, as shown, protrusion406may be arranged with the branch member100and the shaped notch620may be arranged with the pump200.

The shaped notch620may be a j-shaped hook that facilitates torque locking between the branch member100and the pump200. The protrusion406may be arranged within the shaped notch620to releasably lock the branch member100and the pump200together.

In certain instances, the pump200is configured to facilitate engagement between the anchor element406and the notch620. As noted above with reference toFIG.1, the pump200is coupled to a controller. The controller may include options for different torques, speeds, rotations per minute (RPM), treatment schedules, or other parameters for the pump200. When initially arranged within the branch member100, a torque, speed, or RPMs may be selected that overcomes friction between the protrusion406and the shaped notch620to drive the protrusion406into locking engagement with the shaped notch620. In certain instances, the torque, speed, or RPMs may be higher than an operating torque, speed, or RPM to overcome friction between the protrusion406and the shaped notch620to drive the protrusion406into locking engagement with the shaped notch620.

FIG.24is an illustration of another example branch member100, pump200, anchor element, and receiving structure, according to some embodiments. In certain instances, the anchor element is a first threaded member406and the receiving structure is a second threaded member620. The first threaded member406and the second threaded member620may be oppositely threaded. In addition, the first threaded member406and the second threaded member620are configured to engage to removably fix the pump200within the branch member100. In other instances, the anchor element and the receiving structure may be magnetic instead of threaded features. In addition, the first threaded member406and the second threaded member620may be polymeric, balloon expandable, or self expanding.

In certain instances, the pump200is configured to facilitate engagement between the first threaded member406and the second threaded member620. As noted above with reference toFIG.1, the pump200is coupled to a controller. The controller may include options for different torques, speeds, or rotations per minute (RPM) for the pump200. When initially arranged within the branch member100, a torque, speed, or RPMs may be selected that threads of the first threaded member406and the second threaded member620are drive into locking engagement. In certain instances, the torque, speed, or RPMs may be higher than an operating torque, speed, or RPM to thread the first threaded member406and the second threaded member620together.

In certain instances, the pump200and the branch member100may be interference fit together. The anchor element406and the receiving structure620may be integral structures along a length of the branch member100and pump200to anchor the branch member100and pump200together. In addition, the anchor element406and the receiving structure620may be expandable elements to facilitate the friction or interference fit. In certain instances, the anchor element406and the receiving structure620are representative of a portion of the branch member100and pump200(e.g., sleeve, balloon, or swellable material) that expands after the pump200is pushed into place.

In addition and in certain instances, the branch member100(or pump200) may include a valve922at an outflow end of the branch member100. The valve922may close to prevent backflow through the pump200when the pump200is not in operation. The valve922may include a graft material, film, or a metal (e.g., Nitinol, stainless steel) or a combination thereof.

FIG.25is an illustration of a pump200and expandable braided structure940, according to some embodiments. The pump200is configured to deploy within the access site and to force blood flow through the pump200and into the lumen of the main body. The pump200includes an expandable braided structure940configured to removably fix the pump200within the main body. The braided structure940may be configured to expand within the main body that is implanted within an aorta204.

The braided structure940is configured to fixate the pump200within the main body or within the aorta204without the main body. The braided structure940may expand within a fenestration or portion of the main body. In certain instances, the braided structure940may expand to a diameter larger than the aorta204, vessel, main body, or portal into which the braided structure940is implanted. The braided structure940may also act as an integrated filter. In certain instances, the braided structure940may include a membrane.

The braided structure940may include a snaring element942configured to facilitate collapsing of the braided structure940in response to tension. The snaring element942may be formed by terminating ends of the braided structure940forming a ring or other snareable structure. In other instances, the snaring element942may be a loop or ball coupled to the braided structure940. Applying tension to the braided structure940collapses the braided structure940to enable removal and placement of the braided structure940.

FIG.26is an illustration of an example shunt270with flanges520a,520and a driveline400arranged through the shunt270, according to some embodiments. Similar to the branch member100with flanges520a,520bdiscussed above with reference toFIG.10, the shunt270is configured to engage a tissue wall522. The tissue wall522may be the septum of a patient's hear tor along another portion of the heart wall. In certain instances, the shunt270is configured to provide a lumen46for a driveline400.

The shunt270, as shown inFIG.26, may be positioned at a location along the tissue wall522of heart for the driveline400to cross and connect to a controller500, as described in detail above, at one end, with the other end connected to a pump200. In certain instances, the pump200may be located in another portion of the heart (e.g., left atrium connecting to the aorta) without an over docking mechanism such as the branch member100or other anchor system. In these instances, the shunt270may be used to anchor the driveline400.

In certain instances, the lumen46is sized equal to or substantially equal to a circumference of the drive400. In this manner, leakage does not occur through the lumen46. The lumen46being sized equal to or substantially equal to a circumference of the driveline400allows for anchoring therein by, for example, a fiction or interference fit. The shunt270may be formed of a graft, a support structure (such as stent), or a combination thereof. In certain instances, the shunt270may be a coil of wire or film that may tighten about the driveline400. In certain instances, the pump200may be directly or indirectly coupled to the shunt270as is explained in further detail below. In certain instances, the pump200being directly or indirectly coupled to the shunt270may establish a fluidic connection therebetween.

In certain instances, the flanges520a,520bmay include a barrel portion272that connects that flanges520a,520b. The flanges520a,520band the barrel portion272may be a uniform structure, in certain instances, and in other instances, the flanges520a,520band the barrel portion272may be separate structures coupled to attached together prior to implantation. Similar to the branch member100, the flanges520a,520band the barrel portion272may include stent components, graft components, or a combination of stent and graft components.

FIG.27is an illustration of another implantable medical device for cardiac assistance in a delivery configuration, according to some embodiments. As shown inFIG.27, a pump200is arranged in a collapsed configuration for delivery. The pump200includes one or more flanges520a,520b(one flange is shown on an end of the pump200for ease of illustration), as is described in detail above. The flange520ais collapsed toward the pump200in the delivery configuration. In certain instances, the flange520ais held in the collapsed configuration by a lock wire530or similar mechanism. As shown, an end portion580of the lock wire530may be wrapped about the flange520a. The flange520amay be release by pulling back on the lock wire530. In certain instances, the flange520amay be held within a nose cone590rather than or in addition to the lock wire530.

During delivery, the pump200and flange520ais delivered, and when satisfactory positioning is achieved (e.g., within branch member100), the lock wire530and/or the nose cone590is released.

In certain instances, the pump200and flange520amay be arranged such that the flange520aanchors the pump200within the atrial septum. The pump200may then be arranged across the pulmonary vein and configured to pull blood from the vein (and/or left atrium) thru the pump200for increased blood flow. The pump200may be arranged within a branch member100and within the pulmonary vein as is described in further detail above with reference toFIG.14. An opposite end of the pump200(the side not anchored within the pulmonary vein) may extend into the aorta as also described in detail above.

FIG.28is an illustration of a pump200and delivery sheath314, according to some embodiments. The pump200includes anchor elements406extending from an exterior surface of the pump200. The anchor elements406, as shown inFIG.28, are s-hook elements that fit around or are integrated with the pump200. The anchor elements406may be configured to either interference or friction fit the pump200within a branch member100, or the branch member100may include a receiving structure as described in detail above (e.g.,FIG.22).

In certain instances, a delivery sheath314may depress or crush the anchor elements406against the pump200to allow for the pump200to deploy and/or be removed from the branch member100.

In certain instances, a lock wire530may be arranged with and coupled to the pump200. The lock wire530may be extend along the driveline400. the lock wire530may form a portion of or can be integral with the driveline400, or the lock wire530may be arranged within the driveline400. The lock wire530may be pulled back to via the driveline400or separately from the driveline400to remove the pump200. The pump200may be replaced or a new pump200may be reinstalled to continue functionality of the cardiac assistance device. Pulling on the lock wire530overcomes the anchor elements406and may remove the pump200from the branch member100.

A biocompatible material for the graft components or membrane components, discussed herein, may be used. In certain instances, the graft may include a fluoropolymer, such as a polytetrafluoroethylene (PTFE) polymer or an expanded polytetrafluoroethylene (ePTFE) polymer. In some instances, the graft may be formed of a polyester, a silicone, a urethane, a polyethylene terephthalate, or another biocompatible polymer, or combinations thereof. In some instances, bioresorbable or bioabsorbable materials may be used, for example a bioresorbable or bioabsorbable polymer. In some instances, the graft can include Dacron, polyolefins, carboxy methylcellulose fabrics, polyurethanes, or other woven or film elastomers.

In addition, nitinol (NiTi) may be used as the material of the frame or stent (and any of the frames discussed herein), but other materials such as stainless steel, L605 steel, polymers, MP35N steel, polymeric materials, Pyhnox, Elgiloy, or any other appropriate biocompatible material, and combinations thereof, can be used as the material of the frame. The super-elastic properties and softness of NiTi may enhance the conformability of the stent. In addition, NiTi can be shape-set into a desired shape. That is, NiTi can be shape-set so that the frame tends to self-expand into a desired shape when the frame is unconstrained, such as when the frame is deployed out from a delivery system.

The invention of this application has been described above both generically and with regard to specific embodiments. It will be apparent to those skilled in the art that various modifications and variations can be made in the embodiments without departing from the scope of the disclosure. Thus, it is intended that the embodiments cover the modifications and variations of this invention provided they come within the scope of the appended claims and their equivalents.