AMNION AND CHORION CONSTRUCTS AND USES THEREOF IN SPORT INJURY SURGERIES

• US 20120010727A1
• Filed: 07/06/2011
• Published: 01/12/2012
• Est. Priority Date: 07/06/2010
• Status: Abandoned Application

• Current Assignee: Liventa Bioscience Incorporated
• Original Assignee: AFCell Medical
• Inventors: YOUNG, Robin R., JAY, Richard M.
• Application Number:
  US13/177,177
• Publication Number:
  US 20120010727A1
• Time in Patent Office: Days
• US Class Current: 623/23.72
• CPC Class Codes: A61F 2/08 Muscles; Tendons; Ligaments sutures A61B17/04
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: A61L 27/3641 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60

Abstract

Improved methods for sport injury surgeries are described. The improvement includes covering a damaged site of fascia with at least one of an amniotic fluid and a construct for use in surgical repair of the sport injury prior to wound closing. The construct contains an allograft comprising at least one layer of human amnion and chorion tissues and the construct has a size and shape suitable for covering the damaged site of fascia. The method improves fascial membrane repair, reduces complications and recovery time of sport injury surgeries.

Claims

1. A construct for use in surgical repair of a sport injury, the construct comprising an allograft comprising at least one layer of human amnion and chorion tissues, wherein the construct has a size and shape suitable for covering a damaged site of fascia.

2. The construct of claim 1 further comprising a frame that is disposable or implantable and resorbable.

3. The construct of claim 2, wherein the frame is rigid or semi rigid.

4. The construct of claim 1, having a shape selected from the group consisting of double wing shapes, single wing shapes, burn cover shapes, diamond shapes, articulating cup shapes, ligament, tendon and nerve tube shapes.

5. The construct of claim 1, having one or more rounded or flattened corners.

6. The construct of claim 1, further comprising one or more active agents for treatment of the sport injury.

7. The construct of claim 6, wherein the one or more active agents are selected from the group consisting of morphogenic proteins, small molecule compounds, pharmaceutical agents, anti-microbial agents, anti-inflammatory agent, agents that prevent scarring, adhesions and tethering of internal tissue of the sport injury site or the surgery site, and analgesics.

8. The construct of claim 1, wherein the human amnion and chorion tissues are obtained using a process comprising:

a. obtaining informed consent from pregnant females;

b. conducting risk assessment on the consented pregnant females to select an amnion donor;

c. procuring after birth placenta from the amnion donor; and

d. obtaining the human amnion and chorion tissues from the placenta.

9. A method of preparing a construct of claim 2, the method comprising drying the allograft comprising at least one layer of human amnion and chorion tissues on the frame.

10. A method of performing a surgical repair of a sport injury in a subject, comprising:

a. surgically repairing the sport injury in the subject; and

b. covering a damaged site of fascia with at least one of an amniotic fluid and a construct for use in surgical repair of the sport injury prior to wound closing,

wherein the damaged site of fascia results from at least one of the sport injury and the surgical repairing step, the construct comprises an allograft comprising at least one layer of human amnion and chorion tissues and the construct has a size and shape suitable for covering the damaged site of fascia.

11. The method of claim 10, further comprising applying one or more allografts comprising at least one layer of human amnion and chorion tissues over one or more suture lines and incisions resulting from the surgical repair to form a cover and barrier over the suture lines and the incisions.

12. The method of claim 10, wherein the sport injury comprises one or more selected from the group consisting of ACL injuries, Achilles tendon ruptures, frozen shoulder (adhesive capsulitis), ankle fractures and injuries, anterior and posterior cruciate ligament injury, chronic blister treatment, bursitis, carpal tunnel, cartilage injuries, elbow injuries, finger fractures, fractured clavicles, golfer'"'"'s elbow (medial epicondylitis), torn groin muscle, hamstring tears, hand ischemia, hip pointer, patellofemoral pain syndrome, lateral epicondylitis (tennis elbow), medial and lateral collateral ligament injury, plantar fasciitis, quadricep pulls and tears, rotator cuff tears, shoulder tendinitis and impingement.

13. The method of claim 10, wherein the construct further comprises a frame that is disposable or implantable and resorbable.

14. The method of claim 10, wherein the construct has a shape selected from the group consisting of double wing shapes, single wing shapes, burn cover shapes, diamond shapes, articulating cup shapes, ligament, tendon and nerve tube shapes.

15. The method of claim 10, wherein the construct has one or more rounded or flattened corners.

16. The method of claim 10, wherein the construct comprises at least one layer of human amnion and at least one layer of chorion.

17. The method of claim 10, further comprising administering to the subject one or more additional treatments to the sport injury.

18. The method of claim 10, wherein the amniotic fluid and the human amnion and chorion tissues are obtained using a process comprising:

a. obtaining informed consent from pregnant females;

b. conducting risk assessment on the consented pregnant females to select an amnion donor;

c. procuring the amniotic fluid from the amnion donor;

d. procuring after birth placenta from the amnion donor; and

e. obtaining the human amnion and chorion tissues from the placenta.

19. A kit comprising:

a. at least one of an amniotic fluid and a construct for use in surgical repair of a sport injury; and

b. instructions on how to use the amniotic fluid and the construct in the surgical repair,

wherein the construct comprises an allograft comprising at least one layer of human amnion and chorion tissues, the construct has a size and shape suitable for covering a damaged site of fascia.

20. The kit of claim 19, comprising a plurality of constructs for use in surgical repair of a sport injury, wherein at least two of the plurality of constructs have different shapes or sizes.