WO2002065987A2

WO2002065987A2 - Production of platelet rich plasma and autologous procoagulant

Info

Publication number: WO2002065987A2
Application number: PCT/US2002/004717
Authority: WO
Inventors: Sherwin V. Kevy; May S. Jacobson; Lou Blasetti; Sheryl B. Sullivan; Steven F. Levesque
Original assignee: Harvest Technologies Corporation
Priority date: 2001-02-16
Filing date: 2002-02-19
Publication date: 2002-08-29
Also published as: WO2002065987A3

Abstract

An autologous gel is made from platelet rich plasma and serum obtained from the same single donor. The platelet rich plasma and serum are produced at the same time by a centrifuge adapted to received containers of blood configured to produce the respective components.

Description

PRODUCTION OF PLATELET RICH PLASMA AND AUTOLOGOUS PROCOAGULANT

TECHNICAL FIELD

[01]This invention relates to methods and apparatus for the preparation of autologous procoagulants, platelet rich plasma, and related compositions.

BACKGROUND

[02]Production of platelet rich plasma (PRP) is known. A known system for automated production of platelet rich plasma is described in published international patent application WO 00/61256, the entire disclosure of which is hereby incorporated by reference.

[03]Production of autologous thrombin is known from US 5,643,192. According to that patent, fibrinogen is precipitated from plasma and residual fibrinogen is removed the supernatant by clotting. The resulting serum is combined with calcium chloride and this is then combined with precipitated fibrinogen to make fibrin glue.

SUMMARY OF THE INVENTION

[04]In accordance with the invention a composition is produced that contains platelet rich plasma (PRP) and a procoagulant derived from whole blood. Such a composition may be used for a variety of applications. For example, combining the composition with bone graft material makes an effective bone paste. In the preferred embodiment, the PRP and the procoagulant are autologous whereby risks associated with pooled blood plasma or bovine thrombin are obviated.

[05]The autologous procoagulant comprises serum obtained by allowing whole blood obtained from the patient to clot and then separating the clots from the serum. The clots can be separated from the serum by rimming, filtration, or centrifugation and are preferably separated from the serum by centrifugation that is conducted simultaneously with the centrifugation of whole blood in the process for obtaining the PRP. In the preferred embodiment, the centrifugation of the blood for obtaining the serum is facilitated by an adaptor that fits into the centrifuge described in the aforementioned international application and receives a container of the whole blood. The adaptor fits into one trunion of the centrifuge while a processing disposable for obtaining the PRP fits in the other. The container for the whole blood is preferably an evacuated glass tube sold under the trademark "Vacutainer" but may also be a glass tube known as an SST and described in US 5,533,518 or another appropriate container.

[06]The adaptor is designed so that its physical characteristics match those of the processing disposable carried by the other trunion in the centrifuge, when the centrifuge is operating. To accomplish this, the weight distribution of the adaptor is such that when spinning its center of gravity is essentially at the same location with respect to the centrifuge axis as that of the processing disposable. Preferably, the adaptor is configured such that the product of the mass of the adaptor and that of the container of fluid and their radius of gyration in the centrifuge is approximately equal to the product of the mass of the processing disposable and that of the fluid and their radius of gyration.

[07]In the preferred embodiment the adaptor weighs approximately 92 grams and is configured to be received in a trunion that may also receive a two-chamber processing disposable. To ensure rotation of the trunion having the adaptor therein during the decant step one side of the trunion is weighted slightly. [08]During operation, the processing disposable is supplied with blood (45-55 ml), as described in the referenced international application, and placed in the centrifuge. The adaptor according to the invention is placed in the opposite trunion, and a container of the type that activates clotting factors and having the desired physiological fluid, such as whole blood, but possibly other blood components, is placed in the adaptor.. The preferred container is made of glass and initiates the clotting cascade. After the period of time that allows the blood in the container to clot, the centrifuge is operated to run the process described in the international application. The result is PRP in the processing disposable and serum in the container.

[09]Calcium chloride (10% solution) is added to the recovered serum from the container to form a procoagulant, which is then combined with the PRP to form a gel that may be combined with other materials. In one embodiment, the PRP and procoagulant are combined with powdered bone or bone matrix to form a semi-solid material that can be molded to fill voids in bones.

[10]The calcium chloride and serum may be in the ratio of two or three parts serum to one part calcium chloride and preferably three parts. The preferred ratio of PRP to procoagulant is ten parts PRP to one part procoagulant but ratios between 10: 1 and 3:1 have potential application.

[11] Applicants have found that the procoagulant serum has an extended half- life of up to six hours and that clotting times are clinically acceptable. At room temperature, clotting time is about three minutes. When the composition is warmed to about 37°C, clotting time decreases to about two minutes. While these clotting times are somewhat longer than that provided by known techniques using bovine thrombin, the additional time is not significant in light of the advantages achieved by the elimination of bovine thrombin and the use of autologous materials only.

[12]In yet another embodiment of the invention, propyl gallate is added to the composition to reduce clotting time even further.

BRIEF DESCRIPTION OF THE DRAWINGS

[13]The figure is an assembly view of an adaptor in accordance with invention and a fluid container.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIEMENT

[14] With reference to the drawing figure, an adaptor 2 is configured such that it can be placed in a trunion of the type that can also receive a processing disposable having two chambers. The adaptor is also configured to receive a fluid container 4, such as a Nacutainer® tube.

[15]The adaptor 2 is preferably made of delrin, an acetal homopolymer, and includes a first counterweight 6, a second counterweight 8 and a connector 10 connecting the upper portions of the two counterweights. The first part includes an open cylinder 12 for receiving the fluid container 4, and the second part not only fits in the trunnion but also provides strength to withstand the forces created during centrifugation. The adaptor is configured such that the weight distribution approximates that of a processing disposable having fluid therein whereby the balance of the centrifuge is optimized during use.

[16]The preferred process is as follows:

[17]Example 1 : Whole blood obtained from a patient is placed in a processing disposable. Whole blood obtained from the same patient is placed in a serum container and allowed to clot. Then the processing disposable and serum container are placed in a centrifuge, which is preferably that sold under the trademarks SmartPrep and Symphony. The centrifuge is operated to perform the process described in WO 00/61256. Such a process produces PRP of desired concentration and also separates the clots from the serum in the serum container. The serum is removed from the container and mixed with 10% CaCl in the ratio of three parts serum to one part CaCl₂ to provide autologous procoagulant. This autologous procaogulant is then mixed with the PRP, which is then used alone or combined with desired materials such as bone powder. The preferred mixture is ten parts PRP to one part autologous procoagulant.

[18]Example 2: The PRP is warmed to about 37°C for five minutes and mixed with the autologous procoagulant at the same ratio as in example 1. The clotting time of the mixture is approximately three to four minutes.

[19]Example 3: The PRP is mixed with propyl gallate and then mixed with autologous procoagulant in the noted ratio. This provides a reduced clotting time.

[20]Example 4: The PRP is mixed with propyl gallate and warmed to about 37° and them mixed with the autologous procoagulant in the noted ratio. The clotting time of the mixture is reduced to about one to two minutes.

[21]Modifications within the scope of the appended claims will be apparent to those of skill in the art.

Claims

70869-85We Claim:

1. A method for making a physiological product comprising the steps of obtaining whole blood from a donor, processing a first portion of said whole blood in a centrifuge to obtain a concentrated platelet product and simultaneously processing a second portion of said whole blood in said centrifuge to obtain serum, and mixing said concentrated platelet product and said serum to produce said physiological product.

2. A method according to claim 1 wherein said first and second portions are obtained from a single donor.

3. A method according to claim 1 further comprising the step of adding calcium ions to said serum.

4. A method according to claim 1 further comprising the step of warming said physiological product to a temperature higher than room temperature.

5. A method according to claim 4 wherein said temperature is about 37°C.

6. A method according to claim 3 further comprising adding propyl gallate to said physiological product.

7. A method according to claim 6 further comprising warming said physiological product to a temperature of about 37°C.

8. A method according to claim 1 wherein said step of processing a second portion of whole blood comprises adding said second portion of whole blood to a container that initiates clotting and subjecting said whole blood to centrifugation in said centrifuge after said whole blood has clotted.

9. A composition comprising a gel made from platelet rich plasma from a single donor and serum from said single donor. 70869-85

10. A composition according to claim 9 further comprising propyl gallate.

11. A composition according to claim 9 wherein said serum further comprises calcium chloride.

12. Apparatus comprising a first counterweight, a second counterweight, and a connector extending between upper parts of said first and second counterweights to secure them together, wherein said second counterweight provides a cavity configured to receive a container.

13. A method comprising placing the apparatus of claim 12 in a centrifuge, placing a processing disposable having blood therein in said centrifuge, placing a container having blood therein in a cavity in said apparatus, wherein said apparatus is configured to minimize imbalance in said centrifuge.