Drug Delivery Systems and Methods

Abstract

Drug delivery systems and methods are disclosed herein. In some embodiments, a drug delivery system can be configured to deliver a drug to a patient in coordination with a physiological parameter of the patient (e.g., the patient's natural cerebrospinal fluid (CSF) pulsation or the patient's heart or respiration rate). In some embodiments, a drug delivery system can be configured to use a combination of infusion and aspiration to control delivery of a drug to a patient. Catheters, controllers, and other components for use in the above systems are also disclosed, as are various methods of using such systems.

1 . A catheter implantable into a body cavity of a patient, the catheter comprising:
 a body extending between a proximal end and a distal end;   at least one lumen extending within the body;   a distal outlet at the distal end of the body; and   a plurality of radial outlets staggered along the length of the body and arrayed about a circumference of the body.   
     
     
         2 . The catheter of  claim 1 , wherein the plurality of radial outlets have a total cross-sectional area less than a cross-sectional area of the distal outlet. 
     
     
         3 . The catheter of  claim 1 , wherein the distal outlet comprises staggered-bifurcated distal outlets. 
     
     
         4 . The catheter of  claim 3 , further comprising a control wire coupled to at least one of the staggered-bifurcated distal outlets, the control wire actuatable to bifurcate the staggered-bifurcated distal outlets in situ. 
     
     
         5 . The catheter of  claim 1 , wherein the at least one lumen comprises a plurality of lumens extending within the body. 
     
     
         6 . The catheter of  claim 5 , wherein the distal outlet comprises a plurality of distal outlets of the plurality of lumens disposed in an spiral configuration at the distal end of the body. 
     
     
         7 . The catheter of  claim 5 , wherein the plurality of radial outlets comprise a plurality of radial outlets of one or more of the plurality of lumens having varying sizes. 
     
     
         8 . The catheter of  claim 5 , wherein the plurality of radial outlets comprise a helical cut in one or more arcs of a side lumen of the plurality of lumens. 
     
     
         9 . The catheter of  claim 5 , wherein at least one of the plurality of lumens has a crescent or arc shaped transverse cross-section. 
     
     
         10 . The catheter of  claim 5 , wherein one of the plurality of lumens comprises a dedicated guidewire lumen configured to receive a removable guide wire therethrough. 
     
     
         11 . The catheter of  claim 1 , further comprising steerable wires extending within the body. 
     
     
         12 . The catheter of  claim 1 , wherein the body further includes radio-opaque marks disposed adjacent to one or more of: the distal outlet, a proximal end of the plurality of radial outlets, or a distal end of the plurality of radial outlets. 
     
     
         13 . The catheter of  claim 1 , wherein the body comprises a selectively expandable body. 
     
     
         14 . The catheter of  claim 13 , wherein the selectively expandable body comprises an outer sheath expandable from a first, bunched configuration to a second, extended configuration. 
     
     
         15 . The catheter of  claim 13 , wherein the selectively expandable body comprises a proximal portion configured to be wrapped around a subcutaneous port, such that rotation of the port causes the body to expand. 
     
     
         16 . The catheter of  claim 1 , further comprising a retention mechanism to selectively hold the body in a desired position within the body cavity. 
     
     
         17 . The catheter of  claim 16 , wherein the retention mechanism comprises a balloon having a first inflation state in which the balloon centers the body within the body cavity and allows fluid flow past the balloon and a second inflation state in which the balloon occludes the body cavity. 
     
     
         18 . The catheter of  claim 17 , wherein the balloon is coupled to the body adjacent to the proximal to control or limit flow in the distal direction or distal end to control or limit flow in the proximal direction. 
     
     
         19 . The catheter of  claim 17 , wherein the balloon comprises a plurality of balloons inflatable at the same time to control or limit flow between the balloons or to hold the therapeutic in the designated location 
     
     
         20 . The catheter of  claim 17 , wherein the balloon is fixed to the body. 
     
     
         21 . The catheter of  claim 16 , wherein the retention mechanism comprises a shape-memory wire extendable from a storage position within the body to a retention position in a preformed shape to anchor body within the body cavity. 
     
     
         22 . The catheter of  claim 1 , wherein the body comprises a multi-layer architecture including an inner liner layer, a reinforcement layer, and an outer-jacket 
     
     
         23 . The catheter of  claim 22 , wherein the reinforcement layer comprises a braided or coiled layer. 
     
     
         24 . The catheter of  claim 23 , wherein the reinforcement layer further comprises steering wires configured to navigate the body within the body cavity. 
     
     
         25 . The catheter of  claim 22 , wherein the multi-layer architecture comprises a structural layer having a pattern of perforations alternating with a hydrophilic or nano-porous layer allowing localized permeation. 
     
     
         26 . The catheter of  claim 25 , wherein the structural layer comprises two structural layers defining a reservoir therebetween. 
     
     
         27 . The catheter of  claim 25 , wherein the hydrophilic or nano-porous layer contains treatment configured to be released on contact with a predetermined fluid or with infusion pressure. 
     
     
         28 . The catheter of  claim 1 , wherein the body includes outwardly extending longitudinal ridges forming longitudinal channels on an exterior surface of the body to exterior create flow channels. 
     
     
         29 . The catheter of  claim 1 , further comprising one or more dosages of a therapeutic used to treat one or more of: Parkinson's, Friedreich's Ataxia, Canavan's disease, ALS, Congenital Seizures, Drevets Syndrome, pain, SMA, Tauopathies, Huntington's, Brain/Spine/CNS tumors, inflammation, Hunters, Alzheimer's, hydrocephalus, Sanfillippa A, B, Epilepsy, Epilepsy pre-visualase, PCNSL, PPMS, Acute disseminated encephalomyelitis, Rx of motor fluctuations in advanced Parkinson's patients, Acute repetitive seizures, Status epilepticus, ERT, or Neoplastic meningitis. 
     
     
         30 . The catheter of  claim 1 , further comprises one or more dosages of antisense oligonulceotides, Adeno Viruses, Gene therapy (AAVs and non-AAV) including gene editing and gene switching, Oncolytic immunotherapies, monoclonal and polyclonal antibodies, stereopure nucleic acids, small molecules, methotrexate, Edavaronc-conjugate, Conotoxin, abomorphinc, Prednisolone hcmisuccinate sodium, Carbidopa/Levodopa, tetrabenazine, BZD (Diazepam and Midazolam), Alphaxalone or other derivative, Cyclophosphamide, Idursulfase (Elaprase), Iduronidase (Aldurazyme), Topotecan, or Buslfan.