Body lumen fluid delivery device
A method and apparatus for fluid delivery enables navigation through tortuous, spatially restricted body anatomy to access narrow diameter body lumens for the continuous delivery of fluids, including therapeutic fluids, to the lumen in an atraumatic manner that avoids damage to the body lumen. The fluid delivery device can have a flexible conduit having a proximal end, a distal end, and a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal and distal ends, where the lumen transitions into a micro-lumen exiting through a port through which a high concentration of fluid injected into the lumen exits laterally out along an image viewable zone at the distal end of the flexible conduit. The flexible conduit has a maximum outer diameter sized sufficient to navigate narrow diameter body lumens.
1. A method for delivery of a fluid to a target body location, comprising:
providing a flexible conduit, wherein the flexible conduit comprises:
a proximal end, a distal end, an image viewable zone disposed along an exterior of the flexible conduit at a predetermined location suitable for delivery of a fluid from the device, the image viewable zone defined by one or more markers viewable in vivo by an imaging device; and
a lumen extending along an interior of the flexible conduit providing a fluid flow path between the proximal end and the distal end for a fluid injected into the conduit, the lumen transitioning into a micro-lumen exiting from the flexible conduit at a port at the image viewable zone, the port configured in such a way as to direct a relatively high concentration of fluid primarily laterally along the image viewable zone, wherein the micro-lumen has a maximum cross-sectional flow area of 0.01 mm, and wherein the flexible conduit has a maximum outer diameter of 1.1 mm or less;
advancing a guidewire to a target body location to be treated with a therapeutic fluid;
advancing the flexible conduit along the guidewire under image guidance utilizing the imaging device to view the image viewable zone until the distal end of the flexible conduit reaches a lumen within the target body location; and
supplying the fluid into the flexible conduit causing the fluid to exit through and out the port at the image viewable zone at a rate insufficient to damage tissue proximal to the device.
2. The method of claim 1 , wherein the imaging device utilizes image viewing technology in the form of one or more of radiography, magnetic resonance imaging, nuclear imaging, photo acoustic imaging, thermal imaging, or ultrasound.
3. A method for localized gene delivery, comprising:
providing a flexible conduit, wherein the flexible conduit comprises:
a proximal end and a distal end;
an image viewable zone disposed along an exterior of the flexible conduit at a predetermined location suitable for delivery of a fluid from the device, the image viewable zone defined by one or more markers viewable in vivo by an imaging device; and
a lumen extending along an interior the flexible conduit providing a fluid flow path between the proximal end and the distal end for a fluid injected into the conduit, the lumen transitioning into a micro-lumen exiting from the flexible conduit at a port at the image viewable zone, the port configured in such a way as to direct a relatively high concentration of fluid primarily laterally along the image viewable zone, wherein the micro-lumen has a maximum cross-sectional flow area of 0.01 mm, and wherein the flexible conduit has a maximum outer diameter of 1.1 mm or less;
advancing a guidewire to a target body location to be treated with a gene therapy vector;
advancing the flexible conduit along the guidewire under image guidance utilizing the imaging device to view the image viewable zone until the distal end of the flexible conduit reaches a lumen within the target body location;
supplying the fluid containing a first gene therapy vector into the flexible conduit at a first time point, causing the fluid to exit through and out the port at the image viewable zone for the localized delivery of the first gene therapy vector within the target body location at a rate insufficient to damage tissue proximal to the flexible conduit.
4. The method of claim 3 , wherein the supplied fluid contains multiple gene therapy vectors.
5. The method of claim 3 , wherein the gene therapy vector contains multiple transgenes.
6. The method of claim 3 , wherein the step of supplying the fluid containing the gene therapy vector is performed at multiple different time points over a period of time.
7. The method of claim 3 , further comprising optionally preflushing the flexible conduit with a serum albumin solution.
8. The method of claim 3 , further comprising supplying the fluid containing a second gene therapy vector into the flexible conduit at a second time point, causing the fluid to exit through and out the port at the image viewable zone for the localized delivery of the second gene therapy vector within the target body location at a rate insufficient to damage tissue proximal to the flexible conduit.
9. The method of claim 8 , further comprising supplying the fluid containing an n th gene therapy vector into the flexible conduit at an n th time point, where n is an integer greater than two, causing the fluid to exit through and out the port at the image viewable zone for the localized delivery of the n th gene therapy vector within the target body location at a rate insufficient to damage tissue proximal to the flexible conduit.
10. The method of claim 9 , wherein some of the n th gene therapy vectors contains the same transgene and some of the n th gene therapy vectors contains a different transgene.
11. The method of claim 3 , wherein the imaging device utilizes image viewing technology in the form of one or more of radiography, magnetic resonance imaging, nuclear imaging, photo acoustic imaging, thermal imaging, or ultrasound.