Implantable medical device for controlled fluid flow distribution among a plurality of treatment catheters
An implantable drug delivery system that includes a drug delivery device configured to deliver a fluid containing one or more pharmaceutical agents to a patient, a plurality of treatment catheters configured to be implanted within the body of a patient and transport the fluid to the two or more treatment sites, and a flow control hub including an inlet connector that fluidically connects to the drug delivery device to receive the fluid, a plurality of outlet connectors that couple to a respective catheter of the plurality of treatment catheters, and one or more flow restrictors that impede the flow of the fluid from the inlet connector to the plurality of outlet connectors to regulate a flow of the fluid through the plurality of treatment catheters under a selected flow distribution.
1 . An implantable drug delivery system configured to deliver one or more pharmaceutical agents to two or more treatment sites within a body of a patient, the system comprising:
a drug delivery device configured to deliver a fluid at a total volumetric flow rate, the fluid comprising the one or more pharmaceutical agents;
a plurality of treatment catheters configured to be implanted within the body of a patient and transport the fluid to the two or more treatment sites; and
a flow control hub configured to passively control and passively regulate a flow of the fluid under a selected flow distribution that divides the total volumetric flow rate of the fluid between the plurality of treatment catheters, each treatment catheter receiving a sub-portion of the total volumetric flow rate, the flow control hub comprising:
an inlet connector that fluidically connects to the drug delivery device to receive the fluid;
a plurality of outlet connectors that each couple to a respective catheter of the plurality of treatment catheters;
a single flow restrictor sized and positioned within a respective fluid pathway from the inlet connector to a respective outlet connector of the plurality of outlet connectors, the single flow restrictor providing a fixed flow restriction that is set before, during or after the system is implanted within the body of the patient and thereafter provides a fixed flow resistance that passively controls the flow of the fluid from the inlet connector to the plurality of outlet connectors and the plurality of treatment catheters under the selected flow distribution and thereby passively regulates and manages fluid flow through the treatment catheters to provide controlled flow rates and a controlled fluid distribution within the plurality of treatment catheters when using the drug delivery device due to a predominate pressure drop created by the single flow restrictor compared to pressure drops along the respective fluid pathway distal to the fixed flow restriction; and
an adjustment mechanism that controls a location of the fluid flowing from the inlet connector through the single flow restrictor to set the selected flow distribution, wherein the adjustment mechanism is configured to be magnetically adjusted percutaneously after implantation to adjust the selected flow distribution,
wherein a ratio of the sub-portions of the total volumetric flow rate flowing through the plurality of treatment catheters is determined by the selected flow distribution of the single flow restrictor within the respective fluid pathways.
2 . The drug delivery system of claim 1 , wherein the drug delivery device comprises a drug pump comprising:
a drug reservoir for receiving the one or more pharmaceutical agents;
a header comprising an outlet connector that fluidically connects to the inlet connector of the flow control hub; and
a pump mechanism configured to pump the fluid comprising the one or more pharmaceutical agents from the drug reservoir through the outlet connector; and
an optional access port disposed on an exterior housing of the drug pump, the access port comprising a self-sealing septum that enables a needle to access the drug reservoir percutaneously.
3 . The drug delivery system of claim 2 , further comprising an intermediate catheter having a proximal end that couples to the outlet connector of the drug delivery device and a distal end that couples to the inlet connector of the flow control hub.
4 . The drug delivery system of claim 2 , wherein the outlet connector of the drug delivery device couples to the inlet connector of the flow control hub.
5 . The drug delivery system of claim 1 , wherein the single flow restrictor comprise a sintered metal, a sintered polymer, a capillary tube, an orifice, circuitous pathway, or a combination thereof.
6 . The drug delivery system of claim 1 , wherein the pressure drop across the single flow restrictor is about 2 to about 10 psi for a flow rate of about 10 microliters/minute.
7 . The drug delivery system of claim 1 , wherein the single flow restrictor provides a theoretical flow resistance of at least 5 times greater than a theoretical flow resistance of each catheter of the plurality of catheters.
8 . The drug delivery system of claim 1 , wherein the single flow restrictor is the same to provide a substantially equal fluid flow distribution to the plurality of treatment catheters.
9 . An implantable drug delivery system configured to deliver one or more pharmaceutical agents to two or more treatment sites within a body of a patient, the system comprising:
a plurality of treatment catheters configured to be implanted within the body of a patient and transport one or more pharmaceuticals agent to two or more treatment sites; and
a drug delivery device configured to deliver a fluid comprising the one or more pharmaceutical agents to the patient through the plurality of treatment catheters, the drug delivery device delivering the fluid at a total volumetric flow rate, the drug delivery device comprising:
a drug reservoir for receiving the one or more pharmaceutical agents;
a header configured to passively control and passively regulate a flow of the fluid under a selected flow distribution that divides the total volumetric flow rate of the fluid between the plurality of treatment catheters, each treatment catheter receiving a sub-portion of the total volumetric flow rate, the header comprising a plurality of outlet connectors that each couple to a respective catheter of the plurality of treatment catheters;
a pump mechanism configured to pump the fluid comprising the one or more pharmaceutical agents from the drug reservoir through the outlet connectors; and
a single flow restrictor sized and positioned within a respective fluid pathway from an inlet connector to a respective outlet connector of the plurality of outlet connectors, the single flow restrictor providing a fixed flow restriction that is set before, during or after the system is implanted within the body of the patient and thereafter provides a fixed flow resistance that passively controls the flow of the fluid from the drug reservoir to the plurality of outlet connectors and the plurality of treatment catheters under the selected flow distribution and thereby passively regulates and manages fluid flow through the treatment catheters to provide controlled flow rates and a controlled fluid distribution within the plurality of treatment catheters when using the drug delivery device due to a predominate pressure drop created by the single flow restrictor compared to pressure drops along the respective fluid pathway distal to the fixed flow restriction; and
wherein the drug delivery device further comprises an adjustment mechanism that controls a location of the fluid flowing from the drug reservoir through the single flow restrictor to set the selected flow distribution,
wherein a ratio of the sub-portions of the total volumetric flow rate flowing through the plurality of treatment catheters is determined by the selected flow distribution of the single flow restrictor within the respective fluid pathways.
10 . The implantable drug delivery system of claim 1 , wherein the drug delivery device further comprises an access port disposed on an exterior housing of the drug delivery device, the access port comprising a self-sealing septum that enables a needle to access the drug reservoir percutaneously.
11 . The drug delivery system of claim 9 , wherein the pressure drop across the single flow restrictor is about 2 to about 10 psi for a flow rate of about 10 microliters/minute.
12 . The drug delivery system of claim 9 , wherein the single flow restrictor provides a theoretical flow resistance of at least 5 times greater than a theoretical flow resistance of each catheter of the plurality of catheters.
13 . The drug delivery system of claim 9 , wherein the single flow restrictor comprises a sintered metal powder or sintered polymer powder.
14 . An implantable medical device comprising:
a flow control hub configured to passively control and passively regulate a flow of fluid under a selected flow distribution, comprising:
an inlet connector configured to fluidically connect to a drug delivery device that delivers a fluid comprising one or more pharmaceutical agents to the inlet connector, the fluid being delivered at a total volumetric flow rate;
a plurality of outlet connectors each configured to fluidically connect to a respective treatment catheter; and
a single flow restrictor sized and positioned within a respective fluid pathway from the inlet connector to a respective outlet connector of the plurality of outlet connectors, the single flow restrictor providing a fixed flow restriction that is set before, during or after implantation of the hub within a body of a patient and thereafter provides a fixed flow resistance that passively controls the flow of the fluid from the inlet connector to the plurality of outlet connectors and the plurality of outlet connectors under the selected flow distribution and thereby passively regulates and manages fluid flow through the treatment catheters to provide controlled flow rates and a controlled fluid distribution within the plurality of treatment catheters when using the drug delivery device due to a predominate pressure drop created by the single flow restrictor compared to pressure drops along the respective fluid pathway distal to the fixed flow restriction; and
an adjustment mechanism that controls a location of the fluid flowing from the inlet connector through the single flow restrictor to set the selected flow distribution, wherein the adjustment mechanism is configured to be magnetically adjusted percutaneously after implantation to adjust the selected flow distribution,
wherein the selected flow distribution divides the total volumetric flow rate of the fluid between the plurality of outlet connectors, each outlet connector receiving a sub-portion of the total volumetric flow rate, and
wherein a ratio of the sub-portions of the total volumetric flow rate flowing through the plurality of outlet connectors is determined by the selected flow distribution of the single flow restrictor within the respective fluid pathways.
15 . The implantable medical device of claim 14 , wherein the single flow restrictor comprise a sintered metal, a sintered polymer, a capillary tube, an orifice, a circuitous pathway, or a combination thereof.
16 . The implantable medical device of claim 14 , wherein the pressure drop across the single flow restrictor is about 2 to about 10 psi for a flow rate of about 10 microliters/minute.
17 . The implantable medical device of claim 14 , wherein the fixed flow restriction is set before implantation.
18 . The implantable medical device of claim 14 , wherein the fixed flow restriction is set during or after implantation.
19 . The drug delivery system of claim 9 , wherein the fixed flow restriction is set before implantation.
20 . The drug delivery system of claim 9 , wherein the fixed flow restriction is set during or after implantation.
21 . The drug delivery system of claim 1 , wherein the fixed flow restriction is set before implantation.
22 . The drug delivery system of claim 1 , wherein the fixed flow restriction is set during or after implantation.
23 . The drug delivery system of claim 1 , wherein the ratio comprises an unequal distribution of the total volumetric flow rate between the plurality of treatment catheters.
24 . The drug delivery system of claim 1 , wherein the ratio comprises a 40:60, 30:70, or 20:80 distribution of the total volumetric flow rate between the plurality of treatment catheters.
25 . The implantable medical device of claim 14 , wherein the ratio comprises an unequal distribution of the total volumetric flow rate between the plurality of outlet connectors.