Method and device for treating blood cholesterol disorders

Inventors

Grifols Lucas, VictorGrifols Roura, Victor

Assignees

Grifols SA

Interested in licensing this patent?

MTEC can help explore whether this patent might be available for licensing for your application.

Publication Number

US-10624924-B2

Patent

Publication Date

2020-04-21

Expiration Date


Abstract

A method and device for treating cholesterol disorders includes administering at least one treatment regime including two or more rounds of plasmapheresis to a patient having abnormal total cholesterol, abnormal LDL levels and/or abnormal HDL levels prior to treatment. Treatment according to the method results in decreased LDL levels in patients having abnormal LDL levels and increased HDL levels in patients having abnormal HDL levels. Each subsequent round of plasmapheresis is conducted weekly, but no more than twice per week.

Core Innovation

The disclosed invention relates to plasmapheresis-based treating of blood cholesterol disorders by administering a treatment regime that includes a first round of plasmapheresis and one or more subsequent rounds. In each round, less than 1000 mL of blood from a patient is treated, the blood is separated into a plasma component and blood cellular components, and the blood cellular components are returned to the patient without the plasma component.

Subsequent rounds are conducted at least two days after a previous round, with scheduling described as weekly but no more than twice per week. The invention addresses patients or donors having abnormal cholesterol measures, including LDL greater than 130 mg/dL for reducing LDL and HDL less than 60 mg/dL, including abnormal total cholesterol, abnormal LDL, or abnormal HDL, for increasing HDL.

Reported outcomes include a decrease in LDL in patients with abnormal or high LDL and an increase in HDL in patients with abnormal or low HDL. A plasmapheresis device is also described for implementing the treatment regime, including a housing, a whole-blood entrance port, plasma or cell separation means, and exit ports for a plasma component and for returning the blood cellular components.

Claims Coverage

The partial content includes two independent methods that cover low-volume plasmapheresis for reducing LDL and increasing HDL. The inventive features combine patient selection based on cholesterol levels with separation of plasma from blood cellular components, return of the blood cellular components, and a minimum inter-round timing requirement for LDL reduction.

Low-volume plasmapheresis for LDL reduction with plasma removed

A method for reducing LDL in a patient having an LDL level greater than 130 mg/dL by identifying such a patient; administering a treatment regime with a first round and one or more subsequent rounds of plasmapheresis where less than 1000 mL of blood is treated in each round; each round separates the blood into a plasma component and blood cellular components and returns the blood cellular components without the plasma component; and subsequent rounds are conducted at least two days after a previous round.

Low-volume plasmapheresis for HDL increase with plasma removed

A method for increasing HDL in a patient having an HDL level less than 60 mg/dL, including abnormal total cholesterol, abnormal LDL, or abnormal HDL levels, by administering a treatment regime with a first round and one or more subsequent rounds of plasmapheresis where less than 1000 mL of blood is treated in each round; each round separates the blood into a plasma component and blood cellular components and returns the blood cellular components without the plasma component.

Across the independent claims, the inventive core is low-volume plasmapheresis in which the plasma component is separated and not returned, while blood cellular components are returned, paired with defined cholesterol-level-based patient selection. The LDL-reduction independent claim further requires that each subsequent round is conducted at least two days after a previous round.

Stated Advantages

Decrease in LDL in patients with abnormal or high LDL.

Increase in HDL in patients with abnormal or low HDL.

Low reported adverse symptoms.

No severe adverse effects.

Documented Applications

Treating blood cholesterol disorders by reducing LDL using a plasmapheresis treatment regime in patients having LDL greater than 130 mg/dL.

Treating blood cholesterol disorders by increasing HDL using a plasmapheresis treatment regime in patients having HDL less than 60 mg/dL with abnormal total cholesterol, abnormal LDL levels, or abnormal HDL levels.

JOIN OUR MAILING LIST

Stay Connected with MTEC

Keep up with active and upcoming solicitations, MTEC news and other valuable information.