TissueMend Arthroscopic Surgical Technique Arthroscopic Insertion of a Biologic Rotator Cuff Tissue Augment After Rotator Cuff Repair
Table of Contents Placement of suture anchors Placement of anteromedial and posteromedial free sutures Retrieval of suture limbs through lateral portal TissueMend attachment Reduction of TissueMend implant Retrieval of Mulberry knots Final repair TissueMend benefits 1 2 3 4 5 6 7 8
Arthroscopic Insertion of a Biologic Rotator Cuff Tissue Augment After Rotator Cuff Repair Richard M. Seldes, MD and Isaac Abramchayev, P.A. Corresponding Address: Richard M. Seldes, MD Director Department of Orthopaedic Surgery Forest Hills Hospital North Shore University - LIJ Health System 102-01 66th Road Forest Hills, NY 11375
Part A: Placement of Suture Anchors Step 1: Standard posterior, anterior and lateral portals are created, using large, clear cannulas. B A Step 2: Rotator Cuff is evaluated and repaired using standard technique. Step 3: Attachment of the rotator cuff to the humeral head is achieved using two double loaded suture anchors. One suture from each anchor is used for rotator cuff repair and the remaining suture is used for later fixation of TissueMend. Step 4: The suture limbs used for TissueMend fixation are left exiting through accessory portals. C D Note: * A & B represent the anteromedial and posteromedial sutures. * C & D represent the anterolateral and posterolateral sutures needed for tissue augment. 1
Part B: Placement of Anteromedial and Posteromedial Free Sutures Step 5: The arthroscope is placed in the lateral portal. B A Step 6: Using a curved suture passer, one free suture is passed through the anteromedial aspect of the repaired rotator cuff. This suture is placed at the medial-most aspect of the repair. Step 7: Both limbs of the suture are pulled through the anterior cannula. Step 8: Using a curved suture passer, one free suture is passed through the posteromedial aspect of the repaired rotator cuff. This suture is placed at the medial-most aspect of the repair. C D Step 9: Both limbs of the suture are pulled through the posterior cannula. Note: * A & B represent the anteromedial and posteromedial sutures. * C & D represent the anterolateral and posterolateral sutures needed for tissue augment. 2
Part C: Retrieval of Suture Limbs Through Lateral Portal Suture management is essential. Take care not to tangle sutures. Step 10: The arthroscope is placed in the posterior portal, with the posterior suture. B A Step 11: Using a suture grasper, one limb from the anterior cannula is retrieved through the lateral portal. Step 12: Once retrieved, the suture is tagged and placed in a secure, recognizable position. B A Step 13: Steps 11 and 12 are repeated for the anterior and posterior suture anchors. Each limb should be positioned in secure, recognizable location. C D Step 14: The arthroscope is placed in the anterior portal. C D Step 15: Steps 11 and 12 are repeated. Note: To aid in suture management, the diagram has been labeled with each of the four sutures (A, B, C, D) to guide in retrieval of suture limbs through lateral portal. 3
Part D: TissueMend Attachment B A C D A B C D Note: To aid in suture management, the diagram has been labeled with each of the four sutures (A, B, C, D) to guide in TissueMend attachment. Suture management is essential. Take care not to tangle sutures. Step 16: Pass the anteromedial suture from the lateral portal through the corresponding corner of the TissueMend device. Step 17: Once passed through the TissueMend, a large Mulberry knot is tied in the suture limb. Step 18: Repeat steps 16 and 17 for anterior, posterior and posteromedial suture limbs that remain in the lateral portal. 4
Part E: Reduction of TissueMend Implant B A C D Step 19: After tying all four Mulberry knots, a trocar is used to help push the tissue augment through the cannula. As you are pushing the TissueMend through the cannula, pull the four suture limbs from the anterior, posterior, and accessory portals. This maneuver reduces the TissueMend through the lateral cannula onto the repaired rotator cuff. 5
Part F: Retrieval of Mulberry Knots Step 20: After the TissueMend is passed through the cannula and reduced down to the repaired rotator cuff, the Mulberry knots are retrieved. C B A D Step 21: Upon retrieval of each individual Mulberry knot, each suture is tied arthroscopically (as shown by A, B, C, D) to secure each corner of the TissueMend device. 6
Part G: Final Repair After retrieval and subsequent tying of all 4 Mulberry knots, the repair is complete. 7
TissueMend Benefits Biocompatibility Analysis Fibroblast nuclei have migrated into TissueMend collagen matrix. Note the lack of fibrous encapsulation surrounding the implanted TissueMend collagen matrix. Note the lack of foreign reaction to the TissueMend collagen matrix. Figure 1 Fibroblast and supporting blood vessels within acellular collagen matrix Final Histology 15 month histology illustrates complete remodeling of TissueMend implant. Fiber orientation has transformed from a random assembly to the highly organized, parallel fibers seen in Figure 2. New tissue has completely integrated with host collagen at the margin of the original defect. Figure 2 Remodeling of implanted collagen device 8
Handling Characteristics TissueMend #2, non-resorbable suture single stitch, mattress technique Strength and Thickness: TissueMend is composed of a single layer of nondenatured collagen fibers. TissueMend is nominally 1mm thick. Suture pull out strength of TissueMend : 35.5 N. The collagen fibers of TissueMend are not chemically crosslinked. Strength: 20.0 MPa 10lb weight Hydration and Storage The TissueMend collagen matrix hydrates in only seconds, thus eliminating tedious wait time and enhancing efficiency in the operating room. TissueMend does not require refrigeration. TissueMend may be stored on the shelves of any hospital or operating room for 2 years. 9
Description TissueMend is a remodelable collagen scaffold derived from bovine skin to be used to reinforce soft tissues where weakness exists. The device is supplied sterile and is provided in sheet form to be trimmed and sutured by the surgeon to meet the individual patient s needs. Indications TissueMend is intended for surgical implantation to reinforce soft tissue where weakness exists and for the repair of damaged or ruptured soft tissue membranes. In addition, the device is intended to reinforce soft tissues that are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff surgery. Contraindictions TissueMend is not designed, sold, or intended for use except as indicated. TissueMend should not be used for patients with a known history of hypersensitivity to collagen or bovine products.
325 Corporate Drive Mahwah, NJ 07430 t: 201 831 5000 www.stryker.com The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings. Always refer to the package insert, product label and/or user instructions before using any Stryker product. Surgeons must always rely on their own clinical judgment when deciding which treatments and procedures to use with patients. Products may not be available in all markets. Product availability is subject to the regulatory or medical practices that govern individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area. The marks bearing the symbol TM are trademarks of Stryker. The marks bearing the symbol are registered trademarks of Stryker. TissueMend is a registered trademark of TEI BioSciences, Inc. Literature Number: LSP52 GC/GS 2.5m 05/05 Copyright 2005 Stryker Printed in USA