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Expandable Shape-Memory Polymers for Suture Anchors

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
88827
Program Year/Program:
2009 / SBIR
Agency Tracking Number:
AR056154
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
MEDSHAPE, INC.
1575 NORTHSIDE DR, STE 440 ATLANTA, GA 30318-4211
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 2
Fiscal Year: 2009
Title: Expandable Shape-Memory Polymers for Suture Anchors
Agency: HHS
Contract: 2R44AR056154-02
Award Amount: $839,860.00
 

Abstract:

DESCRIPTION (provided by applicant): This project will develop a shape-memory polymer suture anchor capable of dynamic expansion that will be specifically designed for patients with poor bone mass density. Suture anchors are screw or wedge-like devices tha t fasten into the bone and are used to secure a detached tendon back onto the bone. Rotator cuff repairs are common surgical procedures involving suture anchors to reduce pain and restore use to an injured shoulder. In 2007, over 460,000 rotator cuff repai rs were performed in the US using 1,030,000 suture anchors. Approximately 25 to 35% of rotator cuff repairs are considered unsuccessfully. A general challenge and constraint in rotator cuff repair is the large amount of soft cancellous bone where the ancho rs must be placed, which makes the anchors more susceptible to migration, loosening/tunnel widening, and pullout. Furthermore, a growing number of patients over 60 years of age are receiving rotator cuff repairs and suffer from osteoporosis. In recent stud ies, over 54% of patients over the age of 60 with shoulder pain had evidence of rotator cuff tears. Patients with poor bone mass densities are highly at risk of device failure as bone density have been correlated to the fixation strength of the suture anch ors. The proposed shape-memory suture anchor will be developed as a tap-in style device, in which the shape- memory effect will be mechanically activated to expand into a wing-shaped device and offer instant fixation. The main advantages of this device are its superior fixation strength in soft bone and increased cyclic performance due to the design's use of shape-memory polymers. The shape-memory suture anchor will also offer reduced complexity and time during installation as a tap-in device, which can uti lize a knotless suture approach. Knotless suture anchors instantly secure tendon fixation upon anchor insertion and do not require the surgeon to tie and pass knots of suture from the anchor to the tendon as in traditional anchors. The broad impact of this work will challenge the paradigm of how suture anchors are designed to work in soft bone by utilizing shape-memory materials and a model to predict pullout strength, which was developed in Phase I. This Phase II looks to continue and expand upon the feasi bility demonstrated and fundamental information obtained in the successful Phase I efforts of this project. The aims of the Phase II have specifically been designed to fundamentally investigate the design and performance of suture anchors while following a n aggressive path towards regulatory approval. The aims involve (1) finalizing the design, (2) developing instrumentation, (3) assessing biocompatibility, (4) validating sterilization, (5) validating performance, and (6) performing a pilot animal study to prove the use of shape-memory suture anchors in-vivo. The primary research team will consist of Chris Yakacki PhD (PI), who is an expert in shape-memory polymers and device testing; Ken Gall PhD, a full professor from Georgia Tech who specializes in shape- memory materials and medical device testing; and Reed Bartz MD, an orthopedic surgeon and expert in arthroscopic shoulder repair. PUBLIC HEALTH RELEVANCE: A growing percentage of the population is remaining physically active as they age. This project is re levant to this percentage of people that experience a debilitating injury such as a rotator cuff tear and suffer from poor bone quality. This project will provide a means to restore function to repaired injury sites with less occurrence of surgical failure and increase patient quality of life.

Principal Investigator:

Christopher M. Yakacki
3035794624
CHRIS@MEDSHAPESOLUTIONS.COM

Business Contact:

Christopher M. Yakacki
kurt.jacobus@medshapesolutions.com
Small Business Information at Submission:

MEDSHAPE SOLUTIONS, INC.
MEDSHAPE SOLUTIONS, INC. 1575 NORTHSIDE DR STE 440 ATLANTA, GA 30318

EIN/Tax ID: 126057814
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No