Methods for making concentrated plasma and/or tissue sealant

• US 5,788,662 A
• Filed: 10/22/1996
• Issued: 08/04/1998
• Est. Priority Date: 12/07/1994
• Status: Expired due to Term

• Current Assignee: Plasmaseal LLC
• Original Assignee: Plasmaseal LLC
• Inventors: Dorian, Randel, Antanavich, Richard D.
• Primary Examiner(s): Kemmerer, Elizabeth C.
• Assistant Examiner(s): Romeo, David S.
• Application Number:
  US08/736,862
• Time in Patent Office: 651 Days
• Field of Search: 210/782, 422/44, 494/31, 494/33, 494/36, 494/45, 604/4, 604/6, 424/530
• US Class Current: 604/6.01
• CPC Class Codes: A61L 24/106 Fibrin; Fibrinogen
• CPC Class Codes: A61M 1/3693 using separation based on different densities of components, e.g. centrifuging
• CPC Class Codes: B01D 2323/30 Cross-linking
• CPC Class Codes: B01D 61/18 Apparatus therefor
• CPC Class Codes: B01D 63/16 Rotary, reciprocated or vibrated modules
• CPC Class Codes: B01D 67/0093 Chemical modification
• CPC Class Codes: B01D 67/00933 by addition of a layer chemically bonded to the membrane
• CPC Class Codes: B04B 2005/0478 with filters in the separation chamber
• CPC Class Codes: B04B 5/0442 with means for adding or withdrawing liquid substances during the centrifugation, e.g. continuous centrifugation

Abstract

An inexpensive device with a disposable cartridge for preparing tissue sealant is disclosed. The device is particularly applicable to stat preparation of autologous tissue sealant. A method of sealing tissue in which the tissue sealant is applied immediately after mixing platelet-rich plasma concentrate (from the device) with a solution of calcium and thrombin is also disclosed. Preparation in the operating room of 5 cc sealant from 50 cc patient blood requires less than 15 minutes and only one simple operator step. There is no risk of tracking error because processing can be done in the operating room. Chemicals added may be limited to anticoagulant (e.g., citrate) and calcium chloride. The disposable cartridge may fit in the palm of the hand and is hermetically sealed to eliminate possible exposure to patient blood and ensure sterility. Adhesive and tensile strengths are comparable or superior to pooled blood fibrin sealants made with precipitation methods. Antifibrinolytic agents (such as aprotinin) are not necessary because the tissue sealant contains high concentrations of natural inhibitors of fibrinolysis from the patient'"'"'s blood. The tissue sealant also contains patient platelets and additional factors not present in available fibrin sealants that promote wound healing.

Claims

1. A method for concentrating blood plasma, comprising:

(a) removing water and proteins from said plasma by contacting said plasma with a concentrator having a molecular weight cutoff of from 2 to 100 kDa to provide concentrated plasma, proteins being removed having a molecular weight smaller than the molecular weight cutoff of said concentrator; and

(b) separating said concentrated plasma from said concentrator.

2. The method of claim 1, wherein said concentrator comprises a material selected from the group consisting of a dextranomer, SEPHADEX, dextramine, polyacrylamide, BIO-GEL P, silica gel, a zeolite, DEBRISAN, cross-linked agarose, starch and alginate gel, either in free bead form or attached to a matrix or embedded into a disc.

3. The method of claim 1, wherein, prior to said contacting step (a), said concentrator is dry.