Device and method for controlling in-vivo pressure

Abstract

A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particularly in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation mechanism may be provided, to remotely activate the adjustable flow regulation mechanism.

What is claimed: 
     
         1 . An implantable device comprising:
 a shunt body adapted for implantation in a septum between a left atrium and a right atrium; and   an adjustable flow regulating mechanism coupled to the shunt body, the adjustable flow regulating mechanism configured to set a blood flow rate within the shunt body as function of a pressure differential between the left atrium and the right atrium, the adjustable flow regulating mechanism further configured to regulate pressure in the left atrium and to set a blood flow rate through the shunt body as function of a pressure differential between the left atrium and the right atrium such that an increase in the pressure differential within a first pressure differential range results in a higher blood flow rate increase through the shunt body as compared to an identical increase in the pressure differential within a second pressure differential range.   
     
     
         2 . The implantable device of  claim 1 , wherein the adjustable flow regulating mechanism is configured to be controlled remotely by a control mechanism comprising at least one of wires, lines, springs, pins, cables, magnets, hooks, latches, electric mechanisms, pressure transducers, telemetry mechanisms, wireless mechanisms, pneumatic mechanisms, and motors. 
     
     
         3 . The implantable device of  claim 1 , wherein the second differential range has an upper limit of approximately 12 mmHg or a lower limit of approximately 20 mmHg. 
     
     
         4 . An implantable device for regulating pressure in a heart chamber, the implantable device comprising:
 a shunt body adapted for implantation in a septum between a left atrium and a right atrium; and   a valve coupled to the shunt body, the valve configured to set a blood flow rate within the shunt body as function of a pressure differential between the left atrium and the right atrium, the valve further configured to regulate pressure in the left atrium and to set a blood flow rate through the shunt body as function of a pressure differential between the left atrium and the right atrium such that an increase in the pressure differential within a first pressure differential range results in a higher blood flow rate increase through the shunt as compared to an identical increase in the pressure differential within a second pressure differential range.   
     
     
         5 . The implantable device of  claim 4 , wherein shunt body is configured to protrude into at least one of the right atrium and the left atrium. 
     
     
         6 . The implantable device of  claim 4 , wherein the valve comprises at least one leaflet. 
     
     
         7 . The implantable device of  claim 4 , wherein the valve comprises a duckbill valve. 
     
     
         8 . The implantable device of  claim 4 , wherein the implantable device is configured to treat a subject having congestive heart failure. 
     
     
         9 . The implantable device of  claim 4 , wherein the implantable device is configured to treat a subject having pulmonary hypertension. 
     
     
         10 . The implantable device of  claim 4 , wherein the second differential range has an upper limit of approximately 12 mmHg or a lower limit of approximately 20 mmHg. 
     
     
         11 . The implantable device of  claim 4 , wherein the shunt body is cylindrical. 
     
     
         12 . The implantable device of  claim 4 , further comprising a catheter configured to percutaneously deliver the implantable device to a hole through the atrial septum. 
     
     
         13 . The implantable device of  claim 12 , wherein the hole is punctured using a guidewire. 
     
     
         14 . The implantable device of  claim 13 , wherein the punctured hole is dilated using a dilator prior to delivering the implantable device. 
     
     
         15 . The implantable device of  claim 12 , wherein the catheter is configured to be delivered through a sheath having an end positioned in the left atrium. 
     
     
         16 . The implantable device of  claim 15 , wherein at least one of the catheter and the sheath comprise radiopaque markers configured for fluoroscopic visualization. 
     
     
         17 . The implantable device of  claim 4 , further comprising a support structure configured to support the shunt body in a hole through the atrial septum. 
     
     
         18 . The implantable device of  claim 17 , wherein the support structure comprises at least first and second support arms configured to respectively engage first and second sides of the atrial septum when deployed. 
     
     
         19 . The implantable device of  claim 18 , wherein the first and second support arms are substantially the same size as one another. 
     
     
         20 . The implantable device of  claim 17 , wherein the support structure comprises at least one of nickel-titanium and stainless steel.