Intra-pericardial drug delivery device with multiple-balloons and method for angiogenesis

Abstract

A catheter and a method for using the catheter for site specific delivery of agents to or collecting agents from biological spaces. The catheter includes an inner shaft longitudinally movable within and outer shaft, each shaft having at least one balloon and at least one lumen formed therein. The catheter prevents leaking through a membrane by sealing the tip passageway through the membrane with inflatable balloons on either side of the membrane. Further, the inflated balloons secure the position of the catheter relative to the biological membrane and biological space targeted for therapy or diagnosis.

What is claimed is:  
     
         1 . A catheter for delivering agents to a defined biological space in vivo comprising; 
 an inner catheter shaft defining at least one inner shaft lumen and having an inner shaft distal tip;    an outer catheter shaft defining at least one outer shaft lumen and having an outer shaft distal tip;    said inner catheter shaft longitudinally movable within and with respect to said outer catheter shaft; and    at least one deployable support member disposed on at least one of said inner catheter shaft and said outer catheter shaft.    
     
     
         2 . A catheter of  claim 1 , wherein said at least one deployable support member comprises at least one inflatable balloon in communication with at least one of said lumens of said inner shaft or said outer shaft.  
     
     
         3 . A catheter of  claim 2 , wherein said at least one deployable support member comprises said at least one inflatable balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         4 . A catheter of  claim 2 , wherein said at least one deployable support member comprises said at least: one inflatable balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         5 . A catheter of  claim 2 , wherein said at least one deployable support member comprises said at least one inflatable balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and said at least one deployable support member comprises said at least one inflatable balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         6 . A catheter of  claim 1 , wherein said at least one deployable support member comprises at least one deployable wire support in communication with at least one of said lumens of said inner shaft or said outer shaft.  
     
     
         7 . A catheter of  claim 6 , wherein said at least one deployable support member comprises said at least one deployable wire support disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         8 . A catheter of  claim 6 , wherein said at least one deployable support member comprises said at least one deployable wire support disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         9 . A catheter of  claim 6 , wherein said at least one deployable support member comprises said at least one deployable wire support disposed on said inner shaft and in communication with said at least one inner shaft lumen, and said at least one deployable support member comprises said at least one deployable wire support disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         10 . A catheter of  claim 1 , wherein said inner shaft distal tip is a needle.  
     
     
         11 . The catheter of  claim 1 , wherein said catheter disposes at least one port disposed proximate to the proximal portion of said catheter and in communication with one of said lumens in said inner shaft, and wherein said lumen is for delivery of an agent to a biological space.  
     
     
         12 . A catheter of  claim 11 , wherein the agent is a therapeutic agent.  
     
     
         13 . A catheter of  claim 11 , wherein the agent is a angiogenic agent.  
     
     
         14  A catheter of  claim 11 , wherein said at least one port is in communication with at least one of said lumens of said inner shaft or said outer shaft and wherein at least one of said lumens is for the inflation of said inflatable balloon.  
     
     
         15 . A catheter of  claim 11  wherein said at least one port is in communication with at least one of said lumens of said inner shaft or said outer shaft and wherein at least one of said lumens is for the deployment of said deployable wire support.  
     
     
         16 . A catheter of  claim 1 , wherein said inner shaft distal tip has orifices formed therein for the delivery of an agent from aid lumen of said shaft to the biological space.  
     
     
         17 . A catheter of  claim 11 , wherein at least one port is in communication with at least one of said lumens of said inner shaft or said outer shaft and wherein at least one of said lumens are for the inflation of said inflatable balloon.  
     
     
         18 . A catheter of  claim 11 , wherein a catheter further comprises at least one inflatable sealing balloon in communication with at least one of said lumens of said inner shaft or said outer shaft thereby providing the isolated delivery of an agent to a biological space.  
     
     
         19 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         20 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         21 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         22 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         23 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         24 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, and disposing said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         25 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         26 . A catheter of  claim 18 , wherein said-catheter disposes said at least one deployable support member comprising at least one-deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         27 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         28 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         29 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         30 . A catheter of  claim 18 , wherein said catheter disposes said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, and disposing said at least, one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         31 . A catheter of  claim 1 , wherein said outer shaft comprises a proximal pusher portion and a distal end portion and said proximal portion is retractable from said distal end portion to reveal said inner catheter shaft.  
     
     
         32 . A method for delivering agents to a defined biological space in vivo comprising: 
 providing a catheter comprising an outer catheter shaft defining at least one outer shaft lumen and having an outer shaft distal tip, and having an inner catheter shaft defining at least one inner shaft lumen and having an inner shaft distal tip, said inner catheter shaft disposed within and movable with respect to said outer catheter, and disposing at least one deployable support member disposed on at least one of said inner catheter shaft and said outer catheter shaft;    guiding said catheter to the surface of the biological space in vivo;    piercing a surface membrane of the biological space with said distal tip;    deploying at least one said deployable support member;    infusing an agent into the biological space;    retracting at least one said deployable support member; and    withdrawing said catheter from said biological space.    
     
     
         33 . The method of  claim 32 , wherein said deployable support member comprises at least one inflatable balloon in communication with at least one of said lumens of said inner shaft or said outer shaft.  
     
     
         34 . The method of  claim 33 , wherein said deployable support member comprises at least one inflatable balloon disposed on and in communication with at least one inner shaft lumen.  
     
     
         35 . The method of  claim 33 , wherein said deployable support member comprises at least one inflatable balloon disposed on and in communication with at least one outer shaft lumen.  
     
     
         36 . The method of  claim 33 , wherein said deployable support member comprises at least one inflatable balloon disposed on and in communication with at least one inner shaft lumen, and said deployable support member comprises at least one inflatable balloon disposed on and in communication with at least one outer shaft lumen.  
     
     
         37 . The method of  claim 32 , wherein said deployable support member comprises at least one deployable wire support in communication with at least one of said lumens of said inner shaft or said outer shaft.  
     
     
         38 . The method of  claim 37 , wherein said deployable support member comprises at least one deployable wire support disposed on and in communication with at least one inner shaft lumen.  
     
     
         39 . The method of  claim 37 , wherein said deployable support member comprises at least one deployable wire support disposed on and in communication with at least one outer shaft lumen.  
     
     
         40 . The method of  claim 37 , wherein said deployable support member comprises at least one deployable wire support disposed on and in communication with at least one inner shaft lumen, and at least one deployable support member comprises at least one deployable wire support disposed on and in communication with at least one, outer shaft lumen.  
     
     
         41 . The method of  claim 32 , wherein the biological space is the pericardial space.  
     
     
         42 . The method of  claim 32 , wherein the biological agent is a therapeutic agent.  
     
     
         43 . The method of  claim 32 , wherein the biological agent is an angiogenic agent.  
     
     
         44 . The method of  claim 32 , further comprising inflating at least one inflatable sealing balloon in communication with at least one of said lumens of said inner shaft or said outer shaft thereby providing the isolated delivery of an agent to a biological space.  
     
     
         45 . The method of  claim 44 , further comprising inflating a deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         46 . The method of  claim 44 , further comprising inflating a deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         47 . The method of  claim 44 , further comprising inflating a deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         48 . The method of  claim 44 , further comprising inflating a deployable support member comprising at least one inflatable balloon in communication with at least one said-outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         49 . The method of  claim 44 , further comprising inflating said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing-said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         50 . The method of  claim 44 , further comprising inflating said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, and disposing said at least one deployable support member comprising at least one inflatable balloon in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         51 . The method of  claim 44 , further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         52 . The method of  claim 44 , further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         53 . The method of  claim 44 , further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         54 . The method of  claim 44 , further comprising deploying a deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         55 . The method of  claim 44 , further comprising deploying said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing said at least one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing-balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         56 . The method of  claim 44 , further comprising deploying said at least one deployable support member comprising at least one deployable wire support in communication with at least one said inner shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, and disposing said at least-one deployable support member comprising at least one deployable wire support in communication with at least one said outer shaft and having said at least one inflatable sealing balloon disposed on said outer shaft and in communication with said at least one outer shaft lumen, thereby providing a supported and isolated infusion of an agent into a biological space.  
     
     
         57 . The method of  claim 32 , wherein said catheter further comprises a proximal pusher portion and a distal end portion and said proximal portion is retractable from said distal end portion to reveal said inner catheter shaft.  
     
     
         58 . A catheter for delivering agents to a defined biological space in vivo comprising: 
 an inner catheter shaft defining at least one inner shaft lumen and having an inner shaft distal tip;    an outer catheter shaft defining at least one outer shaft lumen and having an outer shaft distal tip;    said inner catheter shaft longitudinally movable within and with respect to said outer catheter shaft; and    at least one deployable support means disposed on at least one of said inner catheter shaft and said outer catheter shaft, said deployable supporting means providing securely positioned delivery of said agents to said biological space.    
     
     
         59 . A catheter of  claim 58 , wherein said at least one deployable supporting means comprises at least one inflatable balloon in communication with at least one of said lumens of said inner shaft or said outer shaft.  
     
     
         60 . The catheter of  claim 58 , wherein said deployable support means comprises at least one inflatable balloon disposed on and in communication with at least one inner shaft lumen.  
     
     
         61 . The catheter of  claim 58 , wherein said deployable support means comprises at least one inflatable balloon disposed on and in communication with at least one outer shaft lumen.  
     
     
         62 . The catheter of  claim 58 , wherein said deployable support means comprises at least one inflatable balloon disposed on and in communication with at least one inner shaft lumen, and at least one deployable support means comprises at least one inflatable balloon disposed on and in communication with at least one outer shaft lumen.  
     
     
         63 . The catheter of  claim 58 , wherein said deployable support means comprises at least one deployable wire support in communication with at least one of said lumens of said, inner shaft or said outer shaft.  
     
     
         64 . The catheter of  claim 58 , wherein said deployable support means comprises at least one deployable wire support disposed on and in communication with at least one inner shaft lumen.  
     
     
         65 . The catheter of  claim 58 , wherein said deployable support means comprises at least one deployable wire support disposed on and in communication with at least one outer shaft lumen.  
     
     
         66 . The catheter of  claim 58 , wherein said deployable support means; comprises at least one deployable wire support disposed on and in communication with at least one inner shaft lumen, and at least one deployable support means comprises at least one deployable wire support disposed on and in communication with at least one outer shaft lumen.  
     
     
         67 . The catheter of  claim 58 , wherein the biological space is the pericardial space.  
     
     
         68 . The catheter of  claim 58 , wherein the biological agent is a therapeutic agent.  
     
     
         69 . The catheter of  claim 58 , wherein the biological agent is an angiogenic agent.  
     
     
         70 . The catheter of  claim 58 , wherein said catheter further comprises at least one sealing means in communication with at least one of said lumens of said inner shaft or said outer shaft for providing the isolated delivery of an agent to a biological space.  
     
     
         71 . A catheter of  claim 70 , wherein said at least one sealing means is disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         72 . A catheter of  claim 70 , wherein said at least one sealing means is disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         73 . A catheter of  claim 70 , wherein said catheter disposes said at least one deployable support means in communication with at least one said inner shaft and having said at least one sealing means disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         74 . A catheter of  claim 70 , wherein said catheter disposes said at least one deployable support means in communication with at least one said outer shaft and having said at least one sealing means disposed on said inner shaft and in communication with said at least one inner shaft lumen.  
     
     
         75 . A catheter of  claim 70 , wherein said catheter disposes said at least one deployable support means in communication with at least one said inner shaft and having said at least one sealing means disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         76 . A catheter of  claim 70 , wherein said catheter disposes said at least one deployable support means in communication with at least one said outer shaft and having said at least one sealing means disposed on said outer shaft and in communication with said at least one outer shaft lumen.  
     
     
         77 . A catheter of  claim 70 , wherein said catheter disposes said at least one deployable support means in communication with at least one said inner shaft and having said at least one sealing means disposed on said inner shaft and in communication with said at least one inner shaft lumen, and disposing said at least one deployable support means in communication with at least one said outer shaft and having said at least one sealing means disposed on said outer-shaft and in communication with said at least one outer shaft lumen.  
     
     
         78 . The catheter of  claim 58 , wherein said catheter further comprises a proximal pusher portion and a distal end portion and said proximal portion is retractable from said distal end portion to reveal said inner catheter shaft.