Infusion system for creating micro-environments in a living body

Abstract

The invention provides implantable infusion systems, including apparatus and methods, for prolonged infusion of a carefully designed medicament composition to create and maintain a comprehensive microenvironment at a target area in a living body. The composition may include living cells to treat a particular disease and which deliver exogenous substances to maintain a microenvironment in the living body. The invention contemplates medicament compositions that include stem cells (neuro or otherwise), including homographs and allographs, adhesive peptides, substances which inhibit fiberblast growth, genetically modified cells which produce useful exogenous substances, nerve growth factor (NGF), previously harvested cells from a living body. In another aspect, the invention contemplates the replication of cells in a reservoir, for example, to keep cells alive in a dormant state until infusion.

1 . A method of delivering a medicament composition to a target area of a living body, comprising: 
 providing a device, the device comprising a first reservoir for containing a first portion of the medicament composition, a second reservoir for containing a second portion of the medicament composition and a catheter for delivering the first and second portions of the medicament composition from the first and second reservoirs to the target area of the living body;    providing the first portion of the medicament composition in the first reservoir, the first portion of the medicament composition comprising living cells;    providing the second portion of the medicament composition in the second reservoir, the second portion of the medicament composition comprising an agent that fosters growth of living cells; and    delivering the first and second portions of the medicament composition from the first and second reservoirs via the catheter to the target area of the living body.    
   
   
       2 . The method of  claim 1  wherein the agent in the second reservoir fosters stem cell growth into a particular desired mature cell type.  
   
   
       3 . The method of  claim 1  wherein one or more surfaces of the device are coated with materials that encourage cell preservation.  
   
   
       4 . The method of  claim 1  wherein one or more surfaces of the device are coated with materials that inhibit cell aggregation.  
   
   
       5 . The method of  claim 1  wherein the medicament composition is delivered via the catheter at a controlled rate.  
   
   
       6 . The method of  claim 1  wherein the device further comprises one or more pumps for delivering one or more portions of the medicament composition.  
   
   
       7 . The method of  claim 1  further comprising implanting the device.  
   
   
       8 . The method of  claim 1  wherein the medicament composition includes one or more agents selected from the group consisting of growth factor agents, fluid from embryonic tissue cells, genetically engineered agents, nerve growth factor, ciliary neuronotrophic factor, neuronotrophic factors, neurotrophic agents, neurite promoting factors, surface active agents, humoral agents, chemical agents causing or enhancing the regeneration process, collagen, laminin, fibronectin, living cells, Schwann cells, glial cells, dorsal root ganglia cells, neural crest cells, neural agents, supportive agents, motor nerve growth factor, adhesion molecules, neural cell adhesion molecules, N-Cadherin, fibrin, hormones, estrogen, testosterone, thyroid hormone, corticotropin, insulin, catalase, acidic fibroblast growth factor, basic fibroblast growth factor, forskolin, glia-derived protease inhibitor, ganglioside GM-1, insulin-like growth factor, isaxonine, leupeptin, muscle basal lamina pyronin, hyaluronic acid, neural progenitors, peptides, adhesive peptides, proteins, genetically modified cells, enzymes, co-factors, neurotransmitters, trophins, and previously harvested cells from a patient.  
   
   
       9 . The method of  claim 1  wherein the living cells are stem cells.  
   
   
       10 . The method of  claim 1  wherein the first portion of the medicament composition further comprises one or more agents that support living cells.  
   
   
       11 . The method of  claim 1  wherein the target area is tissue.  
   
   
       12 . The method of  claim 1  wherein the target area is an organ.  
   
   
       13 . The method of  claim 1  wherein the target area is bone.  
   
   
       14 . The method of  claim 1  wherein the target area is cartilage.  
   
   
       15 . The method of  claim 1  wherein the target area is a tendon.  
   
   
       16 . The method of  claim 1  wherein the target area is a nerve.  
   
   
       17 . The method of  claim 1  wherein the target area is a brain.  
   
   
       18 . The method of  claim 1  wherein the target area is an area of trauma.  
   
   
       19 . The method of  claim 1  wherein the target area is an area of trauma to the central nervous system.  
   
   
       20 . The method of  claim 1  wherein the medicament composition promotes the rebuilding of tissue structures.  
   
   
       21 . The method of  claim 20  wherein the tissue structures are selected from the group consisting of nerves, bone, cartilage, tendons and organs.  
   
   
       22 . The method of  claim 1  wherein the medicament composition promotes the regeneration of tissue structures.  
   
   
       23 . The method of  claim 22  wherein the tissue structures are selected from the group consisting of nerves, bone, cartilage, tendons and organs.  
   
   
       24 . A method of delivering living cells to an area of trauma in a patient, comprising: 
 providing a first catheter device containing living cells;    delivering the living cells via the first catheter device to the area of trauma in the patient;    providing a second catheter device containing a medicament composition that fosters the growth of cells; and    delivering the medicament composition via the second catheter device to the area of trauma in the patient to foster the growth of cells delivered via the first catheter device.    
   
   
       25 . The method of  claim 24  wherein the living cells are stem cells.  
   
   
       26 . The method of  claim 25  wherein the medicament composition fosters stem cell growth into a particular desired mature cell type.  
   
   
       27 . The method of  claim 24  wherein one or more surfaces of the first and second catheter devices are coated with materials that encourage cell preservation.  
   
   
       28 . The method of  claim 24  wherein one or more surfaces of the first and second catheter devices are coated with materials that inhibit cell aggregation.  
   
   
       29 . The method of  claim 24  wherein the cells are delivered via the first catheter device at a controlled rate.  
   
   
       30 . The method of  claim 24  wherein the medicament composition is delivered via the second catheter device at a controlled rate.  
   
   
       31 . The method of  claim 24  wherein the first catheter device comprises one or more pumps for delivering the cells.  
   
   
       32 . The method of  claim 24  wherein the second catheter device comprises one or more pumps for delivering the medicament composition.  
   
   
       33 . The method of  claim 24  wherein the first catheter device comprises a reservoir for containing the cells.  
   
   
       34 . The method of  claim 24  wherein the second catheter device comprises a reservoir for containing the medicament composition.  
   
   
       35 . The method of  claim 24  further comprising implanting the first catheter device.  
   
   
       36 . The method of  claim 24  further comprising implanting the second catheter device.  
   
   
       37 . The method of  claim 24  wherein the medicament composition includes one or more agents selected from the group consisting of growth factor agents, fluid from embryonic tissue cells, genetically engineered agents, nerve growth factor, ciliary neuronotrophic factor, neuronotrophic factors, neurotrophic agents, neurite promoting factors, surface active agents, humoral agents, chemical agents causing or enhancing the regeneration process, collagen, laminin, fibronectin, living cells, Schwann cells, glial cells, dorsal root ganglia cells, neural crest cells, neural agents, supportive agents, motor nerve growth factor, adhesion molecules, neural cell adhesion molecules, N-Cadherin, fibrin, hormones, estrogen, testosterone, thyroid hormone, corticotropin, insulin, catalase, acidic fibroblast growth factor, basic fibroblast growth factor, forskolin, glia-derived protease inhibitor, ganglioside GM-1, insulin-like growth factor, isaxonine, leupeptin, muscle basal lamina pyronin, hyaluronic acid, neural progenitors, peptides, adhesive peptides, proteins, genetically modified cells, enzymes, co-factors, neurotransmitters, trophins, and previously harvested cells from a patient.  
   
   
       38 . The method of  claim 24  wherein the first catheter device further contains one or more agents that support living cells.  
   
   
       39 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to tissue.  
   
   
       40 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to an organ.  
   
   
       41 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to bone.  
   
   
       42 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to cartilage.  
   
   
       43 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to a tendon.  
   
   
       44 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to nerve tissue.  
   
   
       45 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to brain tissue.  
   
   
       46 . The method of  claim 24  wherein the area of trauma in the patient is an area of trauma to central nervous system tissue.  
   
   
       47 . The method of  claim 24  wherein the delivery of the cells and the medicament composition promotes the rebuilding of tissue structures.  
   
   
       48 . The method of  claim 47  wherein the tissue structures are selected from the group consisting of nerves, bone, cartilage, tendons and organs.  
   
   
       49 . The method of  claim 24  wherein the delivery of the cells and the medicament composition promotes the regeneration of tissue structures.  
   
   
       50 . The method of  claim 49  wherein the tissue structures are selected from the group consisting of nerves, bone, cartilage, tendons and organs.  
   
   
       51 . A method for delivering a medicament composition to a target area of a living body, comprising: 
 placing a distal end of a catheter in the target area;    delivering through the catheter to the target area a first portion of the medicament composition comprising living cells from a first reservoir; and    delivering through the catheter to the target area a second portion of the medicament composition comprising an agent that fosters growth of the living cells from a second catheter.    
   
   
       52 . The method of  claim 51 , wherein the medicament composition comprises cells.  
   
   
       53 . The method of  claim 53 , wherein the medicament composition comprises cells selected from the group consisting of stem cells, embryonic tissue cells, genetically modified cells, Schwann cells, glial cells, dorsal root ganglia cells, neural crest cells, and neural progenitors.  
   
   
       54 . The method of  claim 53 , wherein the medicament composition comprises cells previously harvested cells from a patient  
   
   
       55 . The method of  claim 51 , wherein the medicament comprises a growth factor.  
   
   
       56 . The method of  claim 55 , wherein the medicament comprises a growth factor selected from the group consisting of nerve growth factor, ciliary neuronotrophic factor, motor nerve growth factor, acidic fibroblast growth factor, basic fibroblast growth factor, and insulin-like growth factor.  
   
   
       57 . The method of  claim 51 , wherein the medicament comprises a protein.  
   
   
       58 . The method of  claim 57 , wherein the medicament comprises a protein selected from the group consisting of laminin, fibronectin, collagen, N-Cadherin, and fibrin.  
   
   
       59 . The method of  claim 51 , wherein the medicament comprises a hormone.  
   
   
       60 . The method of  claim 59 , wherein the medicament comprises a hormone selected from the group consisting of estrogen, testosterone, thyroid hormone, corticotropin, and insulin.  
   
   
       61 . A method for delivering a medicament composition to a target area of a living body, comprising: 
 placing a distal end of a first catheter in the target area;    placing a distal end of a second catheter in the target area;    delivering through the first catheter to the target area a first portion of the medicament composition comprising living cells; and    delivering through the second catheter to the target area a second portion of the medicament composition comprising an agent that fosters growth of the living cells.    
   
   
       62 . The method of  claim 61 , wherein the medicament composition comprises cells.  
   
   
       63 . The method of  claim 62 , wherein the medicament composition comprises cells selected from the group consisting of stem cells, embryonic tissue cells, genetically modified cells, Schwann cells, glial cells, dorsal root ganglia cells, neural crest cells, and neural progenitors.  
   
   
       64 . The method of  claim 63 , wherein the medicament composition comprises cells previously harvested cells from a patient  
   
   
       65 . The method of  claim 61 , wherein the medicament comprises a growth factor.  
   
   
       66 . The method of  claim 61 , wherein the medicament comprises a growth factor selected from the group consisting of nerve growth factor, ciliary neuronotrophic factor, motor nerve growth factor, acidic fibroblast growth factor, basic fibroblast growth factor, and insulin-like growth factor.  
   
   
       67 . The method of  claim 61 , wherein the medicament comprises a protein.  
   
   
       68 . The method of  claim 67 , wherein the medicament comprises a protein selected from the group consisting of laminin, fibronectin, collagen, N-Cadherin, and fibrin.  
   
   
       69 . The method of  claim 61 , wherein the medicament comprises a hormone.  
   
   
       70 . The method of  claim 69 , wherein the medicament comprises a hormone selected from the group consisting of estrogen, testosterone, thyroid hormone, corticotropin, and insulin.  
   
   
       71 . A method for delivering a medicament composition to a target area of a living body from a device comprising a first reservoir housing a first portion of a medicament composition, a second reservoir housing a second portion of a medicament composition, and a catheter for delivering the first and second portions of the medicament composition from the first and second reservoirs to the target area of the living body, the method comprising: 
 delivering the first and second portions of the medicament composition from the first and second reservoirs via the catheter to the target area of the living body,    wherein the first portion of the medicament composition comprises living cells and the second portion of the medicament composition comprises an agent that fosters growth of the living cells.    
   
   
       72 . A method of delivering living cells to an area of trauma in a patient, comprising: 
 delivering the living cells to the area of trauma in the patient via a first catheter device; and    delivering a medicament composition that fosters the growth of cells via a second catheter device to the area of trauma in the patient to foster the growth of cells delivered via the first catheter device.