BLOOD PRODUCT FOR PREVENTING SURGICAL ADHESION

Abstract

A method for preventing surgical adhesion between surfaces that are to be prevented uses a blood product having fibrin. The blood product can be a singled layered blood product having components from plasma, components added to initiate a coagulation process, and components created during the coagulation process. The products and methods can be used for preventing surgical adhesion, for stopping or reducing bleeding in an open surgical wound, and for treating surgical wounds.

Claims

1. A blood product for use in a method for preventing or reducing adhesion during surgery between surfaces where adhesion is to be prevented, comprising the steps of a. identifying surfaces that during surgery will be located close to each other, which surfaces are not intended to adhere to each other; and b. applying a blood product comprising a high concentration of fibrin at one or all of the identified surfaces.

2. A blood product for use in a method for surgical wound treatment comprising the steps of c. Cleaning the wound from foreign material; d. Removing fluids such as blood; e. Applying a blood product to the wound, so the blood product covers the complete wound bed ensuring contact between the blood product and the intact skin boundary surrounding the wound; and f. Covering the wound with a primary sheet; wherein the blood product is selected among: i. multilayered blood products comprising components from whole blood, especially thrombocytes and leukocytes, the blood product comprising a first layer, and a second layer, the first layer being adjacent to the second layer, the first layer defining a first outer surface of the blood product, the first layer comprising a majority of leukocytes and the second layer comprising a majority of thrombocytes; and wherein the blood product is oriented so the first layer is in direct contact with the wound; and ii. single layered blood products consisting of components from plasma, components added to initiate a coagulation process and components created during the coagulation process.

3. A blood product for use in a method for stopping or reducing bleeding in an open surgical wound comprising the steps of g. identifying the bleeding source; h. removing excess fluids such as blood from the area around the bleeding source; i. applying a blood product to the bleeding source; and j. maintaining the blood product in close contact with the bleeding source until bleeding is ceased or reduced; wherein the blood product is selected among: i. multilayered blood products comprising components from whole blood, especially thrombocytes and leukocytes, the blood product comprising a first layer, and a second layer, the first layer being adjacent to the second layer, the first layer defining a first outer surface of the blood product, the first layer comprising a majority of leukocytes and the second layer comprising a majority of thrombocytes; and wherein the blood product is oriented so the first layer is in direct contact with the bleeding source; and ii. single layered blood products consisting of components from plasma, components added to initiate a coagulation process and components created during the coagulation process.

4. The blood product according to any of claims 1-3, wherein the blood product comprise fibrin that have resistance against fibrinolysis.

5. The blood product according to claim 4, wherein the fibrin that have resistance against fibrinolysis comprises fibrin that has been polymerized in 3 dimensions and compressed to a thinner layer sheet.

6. The blood product according to any of the claims 1 to 5, wherein the blood product is reinforced by another structure such as a net (Vicryl net).

7. The blood product according to any of claims 1-6, wherein blood product comprises components from whole blood, especially fibrin, thrombocytes and leukocytes, the blood product comprising a first layer, a second layer and a third layer, the second layer being adjacent to the first layer and the third layer, the first layer defining a first outer surface of the blood product and the third layer defining a second outer surface of the blood product, the first layer comprising a majority of leukocytes, the second layer comprising a majority of thrombocytes and the third layer comprising a majority of fibrin.

8. The blood product according to any of claims 1-7, wherein the blood product consists of components from plasma, components added to initiate a coagulation process and components created during the coagulation process

9. The blood product according to any of claims 1-8, wherein the fibrin, thrombocytes and/or the leukocytes are autologous.

10. The blood product according to any of claims 1-9, wherein the blood product has been modified to extended storage.

11. The blood product according to claim 10, wherein one or more preserving components have been added to the blood product before freezing, freeze drying or drying.

12. A method for preventing or reducing adhesion during surgery between surfaces where adhesion is to be prevented, comprising the steps of a. identifying surfaces that during surgery will be located close to each other, which surfaces are not intended to adhere to each other; and b. applying a blood product comprising a high concentration of fibrin at one or all of the identified surfaces.

13. The method of claim 12, wherein the blood product comprise fibrin that have resistance against fibrinolysis.

14. The method of claim 13, wherein the fibrin that have resistance against fibrinolysis comprises fibrin that has been polymerized in 3 dimensions and compressed to a thinner layer sheet.

15. The method according to any of the claims 12-14, wherein the blood product is reinforced by another structure such as a net (Vicryl net).

16. The method according to claim 12, wherein blood product comprising components from whole blood, especially fibrin, thrombocytes and leukocytes, the blood product comprising a first layer, a second layer and a third layer, the second layer being adjacent to the first layer and the third layer, the first layer defining a first outer surface of the blood product and the third layer defining a second outer surface of the blood product, the first layer comprising a majority of leukocytes, the second layer comprising a majority of thrombocytes and the third layer comprising a majority of fibrin.

17. The method according to claim 12, wherein the blood product consists of components from plasma, components added to initiate a coagulation process and components created during the coagulation process.

18. The method of any of claims 12-17, wherein the fibrin, thrombocytes and/or the leukocytes are autologous.

19. The method according to any of claims 12-18, wherein the blood product has been modified to extended storage.

20. The method according to claim 19, wherein the blood product has been extended by freezing, freeze during or drying.

21. The method according to claim 20, wherein one or more preserving components have been added to the blood product before freezing, freeze drying or drying.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0107] FIG. 1 shows a scientist displaying the single layer patch prepared in Example 1.

[0108] FIG. 2 shows a rat where an incision has been made in the abdomen exposing the uterine horns. The contour of the uterine horns is highlighted by lines.

[0109] FIG. 3 shows a picture of a surgery on a pig, showing a Patch placed on bleeding lesion created on the liver and the bleeding was stopped after applying the patch.

[0110] FIG. 4 shows the progress of healing of a nasal surgical wound using the blood product according to the disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Example 1Preparation of Single Layer Patch

[0111] A frozen plasma bag (450 ml) containing human plasma was thawed and calcium chloride was added to initiate coagulation.

[0112] After coagulation was completed, determined by visual inspection, the outlet tube was opened in one end and the whole plasma bag was compressed, by placing a flat surface with a heavy weight on the bag.

[0113] After compression was complete and the bag was flat, the bag was opened, and the single layer patch removed from the bag.

[0114] The generated single layer patch is illustrated on FIG. 1.

Example 2

[0115] For this example, blood products in form of circular patches were prepared using the method described in example 3 of U.S. Pat. No. 8,980,301 B, which is incorporated by reference.

[0116] A laboratory rat was used for this example. The rat was anesthetized, and an incision made in the abdomen, so the uterine horns were exposed, see FIG. 2.

[0117] The two uterine horns were damaged by cauterizing the uterine horns. On the rat lefts side the lesion was covered with a patch, whereas no covering was applied on the right side.

[0118] After one week, the site was evaluated, and adhesion was clear on the right uterine horn that served as control and no adhesion on the left uterine horn treated with the patch.

Example 3

[0119] For this example, blood products in form of circular patches were prepared using the method described in example 5 in U.S. Pat. No. 8,980,301 B, which is incorporated by reference, except that Copolyester(PET) containers were used instead of polyamide containers.

[0120] A laboratory pig was used for this example. The pig was anesthetized, and an incision made in the abdomen, so the liver was exposed.

[0121] Cuts were made in the liver leading to bleeding from the wounds.

[0122] Patches were placed covering the bleeding lesions on the liver which led to a fast cessation of the bleeding, whereafter the surgical procedure could swiftly be resumed.

[0123] FIG. 3 shows the surgical incision with the patches covering the lesions.

[0124] In a control experiment where no patches were placed over the bleeding lesions, bleeding continued and thereby providing a challenge for the continued surgical procedure.

Example 4Nasal Skin Cancer Surgical Wound

[0125] A patient diagnosed with skin cancer on the nose wing participated in this example.

[0126] A blood sample was collected from the patient and a three layer blood product comprising a first layer comprising a majority of leukocytes, and a second layer comprising a majority of thrombocytes and a third layer comprising majority of fibrin was made by centrifugation according to the methods disclosed in WO 2010/020254A1. The blood product was collected as a patch and used for this example.

[0127] After the skin cancer was removed by surgery the wound was covered by the patch, securing that the patch was covering the whole wound bed and in contact with the intact skin surrounding the wound, and fastened by suture.

[0128] The healing of the wound was followed 3 months after the surgery, and it was seen that the wound healed well and after 3 months no scarring was observed.

[0129] FIG. 4 shows pictures of the wound immediately after the surgery, after the patch has been sutures, after suture removal and after 3 months.