Devices and Methods for Perfusing an Organ

Abstract

The present invention provides devices and methods for use in the perfusion of organs and anatomical regions. In one aspect the present method provides a percutaneously deliverable device for supporting a vessel in a human or animal subject including means for supporting the vessel during delivery of a fluid thereto or collection of a fluid therefrom. In another aspect the invention provides a method for delivery or collection of a fluid to or from an organ or anatomical region in a human or animal subject, the method including the step of supporting a vessel associated with the organ or anatomical region. The devices and methods may be used to deliver, remove or recirculate a therapeutic agent to an organ or anatomical region.

1 . A percutaneously deliverable device for supporting a vessel in a human or animal subject including means for supporting the vessel during delivery of a fluid thereto or collection of a fluid therefrom. 
   
   
       2 . A device according to  claim 1  wherein the means for supporting the vessel is capable of maintaining patency of the vessel during delivery of the fluid thereto or collection of the fluid therefrom. 
   
   
       3 . A device according to  claim 1  wherein the means for supporting the vessel is capable of maintaining patency of the vessel where the fluid pressure in the vessel is less than the minimum pressure normally found in the vessel. 
   
   
       4 . A device according to  claim 1  including a collection catheter component. 
   
   
       5 . A device according to  claim 4  wherein where the device includes a collection catheter component, and the collection catheter component is attached to a pump, the pressure around the intake of the pump is equal to or less than about −90 mmHg. 
   
   
       6 . A device according to  claim 4  wherein where the device includes a collection catheter component, and the collection catheter component is attached to a pump, the pressure around the intake of the pump is equal to or less than about −100 mmHg to −115 mmHg 
   
   
       7 . A device according to  claim 4  wherein where the device includes a collection catheter component, and the collection catheter component is attached to a pump, the pressure around the intake of the pump is equal to or less than about −115 mmHg. 
   
   
       8 . A device according to  claim 4 , wherein the device includes a collection catheter component, and the collection catheter component is attached to a pump, the device is capable of preventing or delaying cavitation in the collection catheter component, or the pump, or a line connecting the collection catheter to the pump. 
   
   
       9 . A device according to  claim 1 , wherein the means for supporting the vessel is capable of maintaining patency of the vessel under conditions of high fluid flow rate in the vessel. 
   
   
       10 . A device according to  claim 9  wherein the fluid flow rate in the vessel is equal to or greater than a value selected from the group consisting of about 20 ml_per minute, 160 ml. per minute, 180 mL per minute., 200 ml_per minute, and 220 mL per minute. 
   
   
       11 . A device according to  claim 9  wherein the fluid flow rate substantially matches the rate of flow of fluid into the vessel from an anatomical region or organ. 
   
   
       12 . A device according to  claim 1 , wherein the means for supporting the vessel includes an expandable member deliverable in a collapsed condition to the vessel and expandable to support the vessel during delivery of fluid thereto or collection of fluid therefrom. 
   
   
       13 . A device according to  claim 12  wherein the expandable member is radially expandable. 
   
   
       14 . A device according to  claim 12  wherein the expandable member includes one or more loop portions, each of the one or more loop portions being attached at a first loop end to a distal end of a lumen, and at a second loop end to a stem extending through the lumen, the one or more loop portions having a collapsed condition in which they are substantially within the lumen, and wherein the one or more loop portions are controllably expandable by advancing the stem to eject the one or more loop portions from the lumen. 
   
   
       15 . A device according to  claim 14  including 2, 3, 4, 5, 6 or more loop portions. 
   
   
       16 . A device according to  claim 12 , wherein the expandable member has a configuration substantially as illustrated with reference to any one of the embodiments shown in accompanying  FIGS. 1   a  to  3  and  5  to  8   c.    
   
   
       17 . A device according to  claim 12 , wherein the expandable member is formed substantially of a material having shape memory properties. 
   
   
       18 . A device according to  claim 12 , wherein the expandable member is formed of a material having substantially super-elastic properties. 
   
   
       19 . A device according to  claim 12 , further including retention means to retain the expandable member in an expanded condition. 
   
   
       20 . A device according to  claim 4 , including means for substantially occluding flow from the vessel thereby allowing the collection catheter to collect substantially all flow entering the vessel. 
   
   
       21 . A device according to  claim 4 , including means for retaining the collection catheter at a distance from the vessel wall such that the lumen of the catheter is prevented from contacting the vessel wall thereby preventing trauma to the vessel wall and/or occlusion of the lumen of the catheter. 
   
   
       22 . A device according to  claim 21  wherein the means for retaining the collection catheter at a distance from the vessel wall is the means for supporting a vessel. 
   
   
       23 . A device according to  claim 12 , wherein the expandable member is capable of anchoring the device at a fixed location in the vessel thereby substantially preventing movement of the device. 
   
   
       24 . A device according to  claim 1 , further including an atraumatic guiding tip for guiding the expandable member into the vessel, such that in use the atraumatic tip makes substantially atraumatic contact with the vessel wall. 
   
   
       25 . A device according to  claim 24  wherein the atraumatic tip is provided 0.25 to 5 centimeters from a distal end of the expandable member. 
   
   
       26 . A device according to  claim 24  wherein the atraumatic tip is flexible, such that in use the tip deforms or deflects upon contact with a wall of the vessel such that trauma to the vessel wall is substantially avoided. 
   
   
       27 . A device according to  claim 24 , wherein the atraumatic tip is shaped, such that in use and upon contacting the vessel wall, trauma to the vessel wall is substantially avoided. 
   
   
       28 . A device according to  claim 24 , wherein the atraumatic tip is curved, such that in use and upon contacting the vessel wall, trauma to the vessel wall is substantially avoided. 
   
   
       29 . A device according to  claim 24 , wherein the atraumatic tip includes, is made from or is coated with a material having a low coefficient of friction. 
   
   
       30 . A device according to  claim 12 , wherein the expandable member is capable of being coupled to a distal region of a guidewire, and an atraumatic tip is provided at a distal end of the guidewire. 
   
   
       31 . A device according to  claim 30  wherein in use, a proximal end of the expandable member is fixedly coupled to the guidewire and a distal end of the expandable member is movable relative to the guidewire. 
   
   
       32 . A device according to  claim 12 , wherein in use, a distal end of the expandable member is fixedly coupled to the guidewire and a proximal end of the expandable member is movable relative to the guidewire. 
   
   
       33 . A device according to  claim 30  wherein the expandable member is integral with the guidewire structure. 
   
   
       34 . A device according to  claim 30  wherein a proximal end of the expandable member is coupled to a first length of a guidewire, and a distal end of the expandable member is coupled to a second length of the guidewire. 
   
   
       35 . A device according to  claim 1 , wherein the vessel is a blood vessel. 
   
   
       36 . A device according to  claim 35  wherein the blood vessel is a vein. 
   
   
       37 . A device according to  claim 36  wherein the vein is selected from the group consisting of a coronary vein (including the coronary sinus), an internal jugular vein, hepatic vein, a renal vein, a cephalic vein, an inferior vesical vein, a pulmonary vein, an internal iliac vein, a portal vein, a splenic vein, a femoral vein, a saphenous vein, a subclavian vein, an intercostal vein, an axillary vessel, a testicular vein, an ovarian vein and tributaries thereof. 
   
   
       38 . A device according to  claim 36  wherein the vein is associated with an organ selected from the group consisting of the heart, lung, liver, kidney, brain, intestine, testicle, ovary, spleen, stomach, prostate, and pancreas. 
   
   
       39 . A device according to  claim 36  wherein the vein is associated with an anatomical region selected from the group consisting of a limb, the pelvis, the chest, the breast and the mesenteric system. 
   
   
       40 . A device according to  claim 1 , including:
 a plurality of support members disposed in an array having an expanded state and a collapsed state, wherein in the collapsed state, the array is sized for delivery to the vessel through a lumen of a catheter, and wherein in the expanded state, the array is sized to be greater than an internal dimension of the catheter, wherein the support members are biased to the expanded state,   
   
   
       41 . A device according to  claim 40  wherein in the expanded state, the support members are substantially parallel to a longitudinal axis of the catheter. 
   
   
       42 . A method for delivery or collection of a fluid to or from an organ or anatomical region in a human or animal subject, the method including the step of supporting a vessel associated with the organ or anatomical region. 
   
   
       43 . A method according to  claim 42  wherein the vessel is maintained substantially patent during delivery of fluid thereto or collection of fluid therefrom. 
   
   
       44 . A method according to  claim 42  wherein the fluid pressure in the vessel is less than the minimum pressure normally found in the vessel. 
   
   
       45 . A method according to  claim 42 , including the step of placing a collection catheter in the vessel, and attaching a pump to the collection catheter. 
   
   
       46 . A method according to  claim 45  wherein the pressure around the intake of the pump is equal to or less than about −90 mmHg. 
   
   
       47 . A method according to  claim 45  wherein the pressure around the intake of the pump is equal to or less than about −100 mmHg to −115 mmHg 
   
   
       48 . A method according to  claim 45  wherein the pressure around the intake of the pump is equal to or less than about −115 mmHg. 
   
   
       49 . A method according to  claim 45 , wherein cavitation in the collection catheter component, or the pump, or a line connecting the collection catheter to the pump is substantially prevented or delayed. 
   
   
       50 . A method according to including the use of high fluid flow rate in the vessel. 
   
   
       51 . A method according to  claim 50  wherein the fluid flow rate in the vessel is equal to or greater than a value selected from the group consisting of about 20 ml_per minute, 160 ml_per minute, 180 mL per minute, 200 ml_per minute, and 220 mL per minute. 
   
   
       52 . A method according to  claim 50  wherein the fluid flow rate substantially matches the rate of flow of fluid into the vessel from an anatomical region or organ. 
   
   
       53 . A method according to  claim 45 , including the step of substantially occluding flow from the vessel thereby allowing the collection catheter to collect substantially all flow entering the vessel. 
   
   
       54 . A method according to  claim 42 , wherein the vessel is a blood vessel. 
   
   
       55 . A method according to  claim 54  wherein the blood vessel is a vein. 
   
   
       56 . A method according to  claim 55  wherein the vein is selected from the group consisting of a coronary vein (including the coronary sinus), an internal jugular vein, hepatic vein, a renal vein, a cephalic vein, an inferior vesical vein, a pulmonary vein, an internal iliac vein, a portal vein, a splenic vein, a femoral vein, a saphenous vein, a subclavian vein, an intercostal vein, an axillary vessel, a testicular vein, an ovarian vein and tributaries thereof. 
   
   
       57 . A method according to  claim 54  wherein the blood vessel is an artery. 
   
   
       58 . A method according to  claim 57  wherein the artery is selected from the group consisting of a coronary artery, a left or right vertebral artery, a left or right internal carotid artery, an inferior vesicle artery, an internal iliac artery, a renal artery, a gastric artery, a splenic artery, a superior or inferior mesenteric artery, an internal iliac artery, an internal mammary artery, an intercostal artery, a right or left testicular artery, a left or right ovarian artery, a pulmonary artery or tributaries thereof. 
   
   
       59 . A method according to  claim 54 , wherein the blood vessel is associated with an organ selected from the group consisting of the heart, lung, liver, kidney, brain, intestine, testicle, ovary, spleen, stomach, prostate, and pancreas. 
   
   
       60 . A method according to  claim 54 , wherein the blood vessel is associated with an anatomical region selected from the group consisting of a limb, the pelvis, the chest, the breast and the mesenteric system. 
   
   
       61 . A method according to  claim 42 , including the step of percutaneously delivering a device according to any one of  1  to  41 . 
   
   
       62 . A method of recovering fluid from a vessel having a net flow direction, the method including the steps of: placing a catheter into the vessel with an exposed central lumen of the catheter facing a direction of ongoing fluid flow in said blood vessel and with the catheter lumen connected to a source for drawing fluid out of the vessel; placing a support member in the vessel in close proximity to a distal tip of the catheter with the support member configured to oppose a wall of the vessel with a force sufficient to prevent collapse of the wall in response to pressures generated at the catheter tip. 
   
   
       63 . A method according to  claim 62  wherein the support member includes an array of elongate support arms, the method including placing the support device in the vessel with the arms substantially parallel to an axis of the catheter or vessel at the catheter tip with the arms opposing a length of the vessel wall. 
   
   
       64 . A method according to  claim 62  wherein the step of placing the support member in the vessel in close proximity to a distal tip of the catheter includes retaining part of the support member within the catheter.