Abstract: Aspects herein relate to systems and methods for delivery of biologic agents to the central nervous system. In various embodiments, a method of administering a therapeutic agent to the central nervous system (CNS) is included. The method can include injecting a therapeutic agent into a first cerebrospinal fluid (CSF) region of the subject. The method can further include establishing fluid communication between a fluid reservoir and a second cerebrospinal fluid (CSF) region of a subject, the fluid having a hydraulic pressure at or above an intracranial pressure. The method can further include infusing a hyperosmotic fluid systemically. Other embodiments, including kits and systems are also included herein.

Abstract: Aspects herein relate to systems and methods for delivery of biologic agents to the central nervous system. In various embodiments, a method of administering a therapeutic agent to the central nervous system (CNS) is included. The method can include injecting a therapeutic agent into a first cerebrospinal fluid (CSF) region of the subject. The method can further include establishing fluid communication between a fluid reservoir and a second cerebrospinal fluid (CSF) region of a subject, the fluid having a hydraulic pressure at or above an intracranial pressure. The method can further include infusing a hyperosmotic fluid systemically. Other embodiments, including kits and systems are also included herein.

Abstract: Aspects herein relate to systems and methods for delivery of biologic agents to the central nervous system. In various embodiments, a method of administering a therapeutic agent to the central nervous system (CNS) is included. The method can include injecting a therapeutic agent into a first cerebrospinal fluid (CSF) region of the subject. The method can further include establishing fluid communication between a fluid reservoir and a second cerebrospinal fluid (CSF) region of a subject, the fluid having a hydraulic pressure at or above an intracranial pressure. The method can further include infusing a hyperosmotic fluid systemically. Other embodiments, including kits and systems are also included herein.

Abstract: Aspects herein relate to systems and methods for delivery of biologic agents to the central nervous system. In various embodiments, a method of administering a therapeutic agent to the central nervous system (CNS) is included. The method can include injecting a therapeutic agent into a first cerebrospinal fluid (CSF) region of the subject. The method can further include establishing fluid communication between a fluid reservoir and a second cerebrospinal fluid (CSF) region of a subject, the fluid having a hydraulic pressure at or above an intracranial pressure. The method can further include infusing a hyperosmotic fluid systemically. Other embodiments, including kits and systems are also included herein.

Abstract: Embodiments herein include polynucleotides, vectors and methods for the insertion and expression of transgenes. In an embodiment, a polynucleotide is included. The polynucleotide can include a JeT promoter or variant thereof, an intron sequence less than 400 bases in length, and a polynucleotide sequence encoding a polypeptide or protein operatively linked to the promoter. In an embodiment, a recombinant vector is included. The recombinant vector can include a JeT promoter or variant thereof, an intron sequence less than 400 bases in length, and a polynucleotide sequence encoding a polypeptide or protein operatively linked to the promoter. Other embodiments are also included herein.

Abstract: Techniques for delivering genetic material to a target tissue site of a patient via a leadless implantable medical device that includes a pump and a stimulation energy delivery element are described. In some examples, delivery of genetic material to the target tissue site causes transgene expression of tissue at the target tissue site, which may result in generation of new cells or modified properties of existing cells of the target tissue site, facilitating more effective and efficient treatment of a disorder of the patient.

Abstract: Embodiments herein include polynucleotides, vectors and methods for the insertion and expression of transgenes. In an embodiment, a polynucleotide is included. The polynucleotide can include a JeT promoter or variant thereof, an intron sequence less than 400 bases in length, and a polynucleotide sequence encoding a polypeptide or protein operatively linked to the promoter. In an embodiment, a recombinant vector is included. The recombinant vector can include a JeT promoter or variant thereof, an intron sequence less than 400 bases in length, and a polynucleotide sequence encoding a polypeptide or protein operatively linked to the promoter. Other embodiments are also included herein.

Abstract: The present invention is directed to systems and methods for delivering therapy for a cardiac disorder, wherein the system comprises a source for supplying a protein formulation containing a protein that is otherwise deficient in cardiac cells in a patient with a cardiac disorder, and a catheter having a proximal end and a distal end for delivering the protein formulation to the pericardial sac region of a human heart.

Abstract: A method for delivering optical stimulation comprises transfecting a target tissue with a light-sensitive channel protein sensitive to light in a wavelength range, delivering light in the wavelength range to the target tissue via an optical stimulation device, substantially simultaneously with delivering light to the target tissue, sensing bioelectric signals, determining a patient therapeutic state based on the bioelectric signals, and adjusting the delivery of the light to the target tissue based on the sensed patient therapeutic state.

Abstract: The present invention is directed to systems and methods for delivering therapy for a cardiac disorder, wherein the system comprises a source for supplying a protein formulation containing a protein that is otherwise deficient in cardiac cells in a patient with a cardiac disorder, and a catheter having a proximal end and a distal end for delivering the protein formulation to the pericardial sac region of a human heart.

Abstract: The present invention is directed to systems and methods for delivering therapy for a cardiac disorder, wherein the system comprises a source for supplying a protein formulation containing a protein that is otherwise deficient in cardiac cells in a patient with a cardiac disorder, and a catheter having a proximal end and a distal end for delivering the protein formulation to the pericardial sac region of a human heart.

Abstract: Methods for delivering first and second fluid compositions to a target location of a subject include delivering the first composition from reservoir of an implantable infusion pump and delivering the second composition through a catheter access port of the implantable infusion device. The access port and reservoir are fluidly coupled to a catheter having a delivery region implanted in the target region. The methods more fully realize the therapeutic potential of infusion devices having both an access port and a reservoir. Strategic use of different agents that compliment the function of each other delivered via either the access port or the reservoir can result in enhanced therapeutic potential.

Abstract: Techniques for delivering genetic material to a target tissue site of a patient via a leadless implantable medical device that includes a pump and a stimulation energy delivery element are described. In some examples, delivery of genetic material to the target tissue site causes transgene expression of tissue at the target tissue site, which may result in generation of new cells or modified properties of existing cells of the target tissue site, facilitating more effective and efficient treatment of a disorder of the patient.

Abstract: Techniques are described that allow an implantable device to sense gastric data and activity data from a patient, and estimate the patient's amount of energy consumed and energy expended based on the sensed data. A system provides feedback to the patient, a family member, or a doctor about the patient's energy consumed, energy expended, and net energy. The data may be provided in table or graphical format, and may show daily or weekly energy balance data or may show a trend of the daily or weekly energy data. The patient may receive feedback by an implanted alert module that provides and audio alert or a vibration alert. In addition, data acquired by the system may be used to adjust the patient's stimulation therapy parameters.

Abstract: The present invention is directed to methods and systems for the treatment of inborn genetic errors or other defects that cause deficiencies of active enzymes or proteins within the cells of the central nervous system. Such methods and systems generally comprise an implantable catheter system designed for the chronic delivery of specially formulated proteins to intrathecal, intracerebroventricular, and/or intraparenchymal regions of the central nervous system. The invention has application in the neuropathic aspects of the broad category of lysosomal storage diseases. These genetic based diseases are the result of insufficient enzyme activity to catabolize specific substances, which thereby accumulate in the cellular lysosomes.

Abstract: A method for delivering optical stimulation comprises transfecting a target tissue with a light-sensitive channel protein sensitive to light in a wavelength range, delivering light in the wavelength range to the target tissue via an optical stimulation device, substantially simultaneously with delivering light to the target tissue, sensing bioelectric signals, determining a patient therapeutic state based on the bioelectric signals, and adjusting the delivery of the light to the target tissue based on the sensed patient therapeutic state.

Abstract: Techniques are described that allow an implantable device to sense gastric data and activity data from a patient, and estimate the patient's amount of energy consumed and energy expended based on the sensed data. A system provides feedback to the patient, a family member, or a doctor about the patient's energy consumed, energy expended, and net energy. The data may be provided in table or graphical format, and may show daily or weekly energy balance data or may show a trend of the daily or weekly energy data. The patient may receive feedback by an implanted alert module that provides and audio alert or a vibration alert. In addition, data acquired by the system may be used to adjust the patient's stimulation therapy parameters.

Abstract: Techniques are described that allow an implantable device to sense gastric data and activity data from a patient, and estimate the patient's amount of energy consumed and energy expended based on the sensed data. A system provides feedback to the patient, a family member, or a doctor about the patient's energy consumed, energy expended, and net energy. The data may be provided in table or graphical format, and may show daily or weekly energy balance data or may show a trend of the daily or weekly energy data. The patient may receive feedback by an implanted alert module that provides and audio alert or a vibration alert. In addition, data acquired by the system may be used to adjust the patient's stimulation therapy parameters.

Abstract: A method for delivering a large molecule to the brain includes administering the large molecule via an intermittent bolus regimen intrathecally to a subject at a level of C3 or above. A method for delivering a large molecule to the brain includes rostrally advancing a catheter in the intrathecal space of a subject until a delivery region of the catheter is located at a level of C3 or above and delivering the large molecule via the delivery region. Employing aspects of such methods, a method for altering eating behavior is described.

Abstract: An intrathecal catheter for delivering fluid to, or withdrawing fluid from, the cerebrospinal fluid compartment of a patient, includes a proximal end and a distal portion. The distal portion has an outer diameter of about 1 mm or less, a bending stiffness of about 0.002 pounds per square inch or less, and a distal end. A delivery region is located between the proximal end and the distal end, and a lumen extends from the proximal end to the delivery region. The catheter may further include a coiled structure region to prevent dislodgement of the catheter from a tissue in which the coiled structure is implanted, for example the cisterna magna. The catheter may also include tines to anchor portions of the catheter, for example to a portion of the spinal canal.