Device and method for processing and producing autologous platelet-rich plasma

Patent metadata

Field	Value
Publication number	US-9603986-B2
Application number	US-201314014542-A
Country	US
Kind code	B2
Filing date	Aug 30, 2013
Priority date	Aug 30, 2013
Publication date	Mar 28, 2017
Grant date	Mar 28, 2017

Abstract

A system and method are provided, including an integrated single-use kit, for processing whole blood to produce platelet rich plasma. A two stage spinning membrane separator, has a first stage for receiving whole blood and separating substantially all red blood cells from plasma and platelets, and a second stage for further separating platelet rich plasma from plasma. A first waste container is in fluid communication with the first stage of the separator for receiving separated red blood cells, while a second waste container is in fluid communication with the second stage of the separator for receiving separated plasma. An outlet line is in fluid communication with the second stage of the separator for receiving platelet rich plasma, and a reinfusion container is removably connected to the outlet line for receiving platelet rich plasma from the second stage of the separator.

First claim

The invention claimed is:

1. An integrated single-use kit forming a closed system for processing whole blood to produce platelet rich plasma comprising:
a two stage spinning membrane separator comprising a housing, first and second concentric, inner and outer membranes mounted interior of the housing, one of the membranes being rotatable relative to the housing and the other of the membranes being fixed relative to the housing, one of the membranes for separating substantially all red blood cells from plasma and platelets, and the other of the membranes for further separating platelet rich plasma from plasma, a central flow path interior of the inner membrane, an outer flow path defined by the housing and the outer membrane, and a gap defined between the inner membrane and the outer membrane;
an inlet line for flowing whole blood to the gap of the separator during a first stage of separation and to flow plasma and platelets separated from the whole blood during the first stage of separation back into the gap during a second stage of separation;
a first waste container in fluid communication with the gap for receiving separated red blood cells;
a second waste container in fluid communication with one of the central flow path and the outer flow path for receiving separated plasma;
an outlet line in fluid communication with the gap for receiving platelet rich plasma separated in the second stage of separation; and
a reinfusion container removably connected to the outlet line for receiving platelet rich plasma from the gap of the separator.

2. The kit of claim 1 , wherein the inlet line further comprises a connector for attaching a collection container thereto.

3. The kit of claim 1 wherein the reinfusion container comprises a syringe for withdrawing platelet rich plasma from the gap of the two stage spinning membrane separator through the outlet line and into the syringe.

4. The kit of claim 1 , wherein one of the inner and outer membranes comprises a filter membrane having an average pore size of from 4 um to 5 um and the other of the inner and outer membranes comprises a filter membrane having an average pore size of approximately 0.65 um.

5. The kit of claim 1 wherein the inner membrane is rotatable relative to the housing and the outer membrane is fixed relative to the housing.

6. A method for producing platelet rich plasma for reinfusion to a donor using the kit of claim 1 , comprising:
obtaining whole blood from the donor in a collection container;
connecting the collection container to the inlet line;
flowing whole blood from the collection container through the inlet line to the first stage of the two stage spinning membrane separator;
separating red blood cells from platelets and plasma in the first stage;
flowing separated platelets and plasma from the first stage to the second stage of the spinning membrane separator;
separating platelet rich plasma from plasma in the second stage of the two stage spinning membrane separator;
flowing the platelet rich plasma from the second stage of the spinning membrane separator through the outlet line to the reinfusion container; and
disconnecting the reinfusion container from the outlet line.

7. The method of claim 6 wherein the collection container comprises a first syringe associated with a first syringe pump for expressing the whole blood from the first syringe to the first stage of the two stage spinning membrane separator, and the reinfusion container comprises a second syringe associated with a second syringe pump for withdrawing platelet rich plasma from the second stage of the two stage spinning membrane separator through the outlet line and into the second syringe.

8. A two-stage system for filtering a cellular suspension, comprising:
A spinning membrane separator in accordance with claim 1 ; and
a motor coupled to the inner membrane for rotating the inner membrane relative to the housing and outer membrane at a rate sufficient to establish Taylor vortices in the gap.

9. The system of claim 8 further comprising selectively controllable valves for controlling the direction of flow through the inner and outer membranes.

10. The kit of claim 5 wherein the inner membrane substantially blocks red blood cells from passing therethrough, while allowing platelets and plasma to pass therethrough and the outer membrane substantially blocks platelets from passing therethrough while allowing plasma to pass therethrough.

11. The kit of claim 10 wherein the inner membrane has an average pore size of from 4 um to 5 um and the outer membrane has an average pore size of from approximately 0.65 um to 0.8 um.

12. The kit of claim 5 wherein the reinfusion container comprises a syringe for withdrawing platelet rich plasma from the gap of the two stage spinning membrane separator through the outlet line and into the syringe.

13. The kit of claim 5 wherein the inlet line further comprises a connector for attaching a collection container thereto.

14. The kit of claim 5 wherein the outer membrane substantially blocks red blood cells from passing therethrough, while allowing platelets and plasma to pass therethrough and the inner membrane substantially blocks platelets from passing therethrough while allowing plasma to pass therethrough.

15. The kit of claim 1 wherein the outlet line is configured to flow the red blood cells separated from the whole blood during the first stage of separation to the first waste container and to flow the platelet rich plasma separated from the plasma and platelets during the second stage of separation to the reinfusion container, and the kit further comprises a second outlet line in fluid communication with one of the central flow path and the outer flow path for flowing the plasma separated from the plasma and platelets during the second stage of separation to the second waste container.

Assignees

• Kusters Benjamin E
• Wegener Christopher J
• Min Kyungyoon
• Fenwal Inc

Inventors

• Kusters Benjamin E
• Wegener Christopher J
• Min Kyungyoon

Classifications

• A61M2205/103

  rotating · CPC title

• A61M2205/75

  with filters · CPC title

• B01D63/16

  Rotary, reciprocated or vibrated modules · CPC title

• A61M1/0218

  with filters · CPC title

• B01D2319/06

  Use of membranes of different materials or properties within one module · CPC title