Membrane and device for treating restless leg syndrome

Patent metadata

Field	Value
Publication number	US-11278651-B2
Application number	US-201816163123-A
Country	US
Kind code	B2
Filing date	Oct 17, 2018
Priority date	Oct 17, 2018
Publication date	Mar 22, 2022
Grant date	Mar 22, 2022

Abstract

The present disclosure relates to a hemodialysis membrane for the treatment of restless leg syndrome (RLS), especially in severe and very severe cases and/or in patients which suffer from kidney failure and already receive hemodialysis. The present disclosure therefore also relates to methods of treating restless leg syndrome. The treatment and method encompasses using a hemodialysis membrane which is characterized in that it comprises at least one hydrophobic polymer and at least one hydrophilic polymer and in that it has a MWRO of between 8.5 and 14.0 kD and a MWCO of between 55 kD and 130 kD.

First claim

The invention claimed is:

1. A method of treating restless leg syndrome (RLS) in a patient, said method comprising the steps of withdrawing and bypassing the blood of the patient in a continuous flow into contact with one face of a membrane, simultaneously passing dialysate solution in a continuous flow on the opposite face of the membrane, and returning the blood to the patient,
wherein the membrane has a MWRO of between about 8.5 kD and about 14.0 kD and a MWCO of between about 55 kD and about 130 kD as determined by dextran sieving before blood contact of the membrane, and
wherein the membrane comprises at least one polymer selected from the group of polymers consisting of polysulfone, polyethersulfone and polyarylethersulfone, and further comprising polyvinylpyrrolidone,
wherein treatment with the membrane reduces one or more RLS symptoms in the patient.

2. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the hollow fiber membrane is characterized in that it has a MWRO of between about 9.0 kD and about 14.0 kD and a MWCO of between about 55 kD and about 110 kD as determined by dextran sieving before blood contact of the membrane.

3. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the patient fulfills the International Restless Legs Syndrome Study Group (IRLSSG) consensus criteria.

4. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the patient has a IRLS score of 11-20 (moderate), 21-30 (severe) or 31-40 (very severe).

5. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the patient has a IRLS score of 11-20 (moderate).

6. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the patient has a IRLS score of 21-30 (severe).

7. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the patient has a IRLS score of 31-40 (very severe).

8. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the patient receives concomitant medication with a dopamine agonist.

9. The method of treating restless leg syndrome (RLS) according to claim 8 , wherein the dopamine agonist is Rotigotine.

10. The method of treating restless leg syndrome (RLS) according to claim 8 , wherein the dopamine agonist is ropinirole.

11. The method of treating restless leg syndrome (RLS) according to claim 8 , wherein the dopamine agonist is levodopa.

12. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the patient is a hemodialysis patient.

13. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the average effective pore size (radius) on the selective layer of the membrane as derived from the MWCO based on dextran sieving is above about 5.0 nm and below about 7.0 nm.

14. The method of treating restless leg syndrome (RLS) according to claim 2 , wherein the average effective pore size (radius) on the selective layer of the membrane as derived from the MWCO based on dextran sieving is above about 5.0 nm and below about 7.0 nm.

15. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the inner diameter of the membrane is below about 200 μm and the wall thickness is below about 40 μm.

16. The method of treating restless leg syndrome (RLS) according to claim 2 , wherein the inner diameter of the membrane is below about 200 μm and the wall thickness is below about 40 μm.

17. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the membrane is comprised in a fiber bundle which has a packing density of from about 53% to about 60% and wherein the fiber bundle comprises at least 80% crimped fibers.

18. The method of treating restless leg syndrome (RLS) according to claim 2 , wherein the membrane is comprised in a fiber bundle which has a packing density of from about 53% to about 60% and wherein the fiber bundle comprises at least 80% crimped fibers.

19. The method of treating restless leg syndrome (RLS) according to claim 1 , wherein the membrane is comprised in a fiber bundle which has a packing density of from about 53% to about 60% and wherein the fiber bundle consists of at least 80% crimped fibers.

20. The method of treating restless leg syndrome (RLS) according to claim 2 , wherein the membrane is comprised in a fiber bundle which has a packing density of from about 53% to about 60% and wherein the fiber bundle consists of at least 80% crimped fibers.

Assignees

• Gambro Lundia Ab

Inventors

• Bernardo Angelito A
• Rivera Florez Angela Sofia
• Nilsson Lars-Goran
• Sanabria Arenas Rafael Mauricio
• Bunch Barrera Alfonso

Classifications

• B01D71/68 Primary

  Polysulfones; Polyethersulfones · CPC title

• B01D69/081

  characterised by the fibre diameter · CPC title

• B01D69/08

  Hollow fibre membranes (manufacture of hollow fibres D01D5/24, D01F1/08) · CPC title

• A61M1/16 Primary

  with membranes · CPC title

• B01D63/02

  Hollow fibre modules · CPC title