eclipse general technique guide - medshape...dual-pronged tip of the fork, grasp the end of the...

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PRODUCT OVERVIEW

IMPLANT SHEATH BULLET

DRIVE CANNULA

SUTURE CLEAT

KNOB LOCK

STRIKE PLATE

KNOB

DEPLOYMENT TRIGGER

TRIGGER LOCK

DISPOSABLE DEPLOYMENT GUN

The Eclipse Soft Tissue Anchor employs MedShape’s shape memory PEEK Altera® technology for soft tissue !xation procedures in the shoulder, elbow, knee, hand & wrist, and foot & ankle. Eclipse features a low-pro!le geometry that expands to compress soft tissue within the bone tunnel upon insertion. The non-rotational deployment provides several unique clinical advantages including strong !xation, easy insertion, proper maintenance of soft tissue orientation and tension, and protection of the soft tissue graft from laceration.

TIPSHEATH

BULLET EXPANDED PROFILE

COMPRESSED PROFILE

SHEATH

BULLET

INITIAL UNDEPLOYED SHAPE FINAL DEPLOYED SHAPE

ACCESSORY INSTRUMENTATION

Universal Tenodesis Procedure PackDisposable kit that contains instruments needed to aid in bone tunnel and soft tissue preparation.

1 " Soft Tissue Sizer2 " 2.4 mm SurgiBit® Stainless Steel Drill Tipped Passing Pin,

Laser Marked3 " Stainless Steel Tendon Fork, Laser Marked4 " 0.7 mm Suture Lasso

QuikWhip™#2 Co-Braid Ultra-High Molecular Weight Polyethylene Surgical Suture

High Tensile Strength Offered in Green and White/Green Co-Braid to help distinguish between soft tissue bundles

Looped design provides easy method to rapidly stitch soft tissue ends

Loaded with 51 mm straight round body needle for easy handling

Cannulated Drill and Reamers

Cannulated Drill, 4 mm, Laser Marked Cannulated Acorn Reamer, 5 mm, Laser Marked Cannulated Acorn Reamer, 6 mm, Laser Marked Cannulated Acorn Reamer, 7 mm, Laser Marked Cannulated Acorn Reamer, 8 mm, Laser Marked Cannulated Acorn Reamer, 9 mm, Laser Marked

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SIZING GUIDE

BONE TUNNEL & IMPLANT SIZINGThe Eclipse Soft Tissue Anchor is available in a range of sizes from 4 to 9 mm in diameter and 10 to 20 mm in length. Selecting the appropriate Implant size should take into account the tendon size and bone quality.

SELECTING BONE TUNNEL DIAMETERMeasure the tendon diameter using the MedShape Soft Tissue Sizer. The bone tunnel diameter should measure 1 mm larger than the tendon diameter. If the tendon measures in a half-mm increment (e.g. 5.5 mm), size the tunnel 1.5 mm larger than the tendon diameter.

SELECTING IMPLANT DIAMETERIn good, healthy bone where there is a suf!cient cortical layer, the Implant should measure 1 mm less than the tunnel diameter (e.g. for a 7 mm tunnel, select a 6 mm Implant).

In poor quality bone, the Implant diameter should equal the tunnel diameter (e.g. for a 7 mm tunnel, select a 7 mm Implant).

SELECTING IMPLANT LENGTHWhen anatomy permits, always select the Implant with the greatest length (e.g. 4x17 mm or 5x20 mm). The 10 and 12 mm length Implants should ONLY be used when there is not suf!cient bone anatomy to accommodate the 17 and 20 mm lengths, respectively.

SELECTING BONE TUNNEL LENGTHWhen drilling a blind bone tunnel, the tunnel should be drilled slightly deeper than the length of the Implant. For a 10 mm Implant, drill a 15 mm tunnel. For a 12 mm Implant, drill a 15 mm tunnel. For a 17 mm Implant, drill a 20 mm tunnel. For a 20 mm Implant, drill a 25 mm tunnel.

DEPLOYMENT GUIDE

STEP 1: PREPARE THE GRAFT

If performing a soft tissue reattachment or transfer, harvest the tendon(s) according to the surgeon’s preferred technique. Using the Soft Tissue Sizer, measure the diameter of the tendon and select the appropriate size Implant (Refer to Sizing Guide on page 4). Using QuikWhipTM #2 Surgical Suture, whipstitch the end of the tendon.

Note: If anchoring the tendon in a blind bone tunnel, tension the tendon and mark where the tendon aligns with the desired insertion site. Make a second marking where the tendon should reach the bottom of the bone tunnel. Using QuikWhipTM #2 Surgical Suture, whipstitch the region between the two markings and trim off any excess tendon.

STEP 2: PREPARE THE BONE TUNNEL

Determine the desired anatomical insertion site. Drill the 2.4 mm Drill Tipped Passing Pin to the appropriate depth by measuring directly off the laser marks of the Passing Pin (Refer to Sizing Guide on page 4 for recommended drill depth guidelines). Drill over the Passing Pin with a cannulated reamer 1 mm larger than the diameter of the tendon.

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DEPLOYMENT GUIDE

Step A: Tendon Fork

If a blind bone tunnel is drilled, the Tendon Fork can be used to insert the tendon PRIOR to Implant insertion. Using the dual-pronged tip of the Fork, grasp the end of the tendon-suture complex and push the tendon to the bottom of the bone tunnel. Verify that the tendon is inserted to the appropriate depth by reading the laser mark measurements on the Tendon Fork. Remove the Tendon Fork.

Note: To maintain tension on the tendon, the Fork may be left in place during the initial Sheath insertion (Step 4).

Step B: Passing Pin

If a transosseous tunnel is drilled, the Passing Pin can be used to insert and tension the tendon PRIOR to Implant insertion. With the drill tip of the Passing Pin placed inside the tunnel, thread the suture strands of the whipstitched tendon through the eyelet of the Passing Pin. Draw the tendon into the tunnel by pulling the Passing Pin completely through the tunnel until the suture strands emerge from the opposing side.

Note: Pull the suture strands to maintain tendon tension during Steps 3 - 6.

STEP 3: TENDON MANAGEMENTThere are three options available for managing and inserting the tendon depending on the type of bone tunnel drilled.

DEPLOYMENT GUIDE

STEP 4: POSITION THE IMPLANT

Refer to Sizing Guide on page 4 for selecting Implant size. Position the Sheath in the tunnel so that the compressed pro!le is adjacent to the tendon. Manually advance the Sheath into the tunnel until the Sheath is 1 - 2 mm sub-#ush. If necessary, lightly mallet the metal Strike Plate on the Gun Knob to assist in advancing the Sheath into the bone tunnel.

Note: To prevent possible damage to the Implant, ensure the trajectory of the Sheath is aligned with the tunnel axis.

Note: If extensive malleting is required to advance the Sheath, increase the tunnel size by 0.5 - 1 mm.

Step C: Suture Lasso

Alternatively, the Suture Lasso may be used for tendon management in a blind or transosseous tunnel. Feed the rod end of the Lasso through the Sheath, thread one suture strand through the Suture Lasso eyelet, and pull the suture strand through the Sheath. The second suture strand should run along the outside of the Implant Sheath. Adjust the tendon so that it rests in the compressed pro!le of the Sheath. Cleat the threads on the Suture Cleat and insert the Sheath and tendon simultaneously into the bone tunnel.

Note: After deployment, remember to uncleat the sutures before releasing the Gun from the Implant.

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DEPLOYMENT GUIDE

STEP 5 (Optional): ROTATE THE GUN BODY

If desired, push forward on the blue Knob Lock to allow free rotation of the Gun Body. The Gun Body can now rotate to the desired deployment position for surgeon comfort without disturbing Implant alignment in the tunnel. Push back on the Knob Lock to re-engage with the Gun Knob, preventing further rotation of the Gun Body.

STEP 6: DEPLOY THE IMPLANT

To release the Deployment Trigger, squeeze the Deployment Trigger while pulling down on the blue Trigger Lock. While maintaining slight forward pressure on the Gun, squeeze the Trigger to advance the Bullet into the Sheath. Signi!cant resistance to squeezing the Trigger indicates deployment. When the Trigger pull no longer exhibits resistance (i.e. bottoms out), the Implant is fully deployed (approximately 2 trigger pulls).

Note: Be sure to apply slight forward pressure while pulling the Trigger to ensure that the Implant remains seated in the tunnel.

DEPLOYMENT GUIDE

STEP 7: RELEASE THE GUN

Push forward on the Knob Lock. Turn the Knob counterclockwise until the Gun releases from the Implant.

STEP 8: FINAL FIXATION

Proceed with the procedure per surgeon preference.

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PRODUCT CATALOG

ECLIPSE SOFT TISSUE ANCHOR

SINGLE USE INSTRUMENTS

MedShape, Inc.1575 Northside Drive, NWSuite 440Atlanta, GA 30318T: 877-343-7016F: 877-343-7017

For further product information or to arrange a product demonstration, please contact your local MedShape representative or call Customer Service at 877-343-7016. You can also visit www.medshape.com.

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. © MedShape, Inc., 2015. All rights reserved. Printed in the USA.Protected by Patent No.: US 8,069,858. Other U.S. and International Patents Pending.MK-10133 Rev 00. Issued 12/2015. PEEK Altera is a registered trademark of MedShape, Inc.QuikWhip is a trademark of Medshape, Inc. SurgiBit® Technology is protected by US Patent No.: D523313, D523398, & US 7,892,2235 B2. Foreign patents and design application pending and granted. All other trademarks are trademarks of their respective owners or holders.

Part No. Description 1101-03-000 QuikWhip Green Co-Braid USP #2 Suture, Sterile

1101-04-000 QuikWhip White/Green Co-Braid USP #2 Suture, Sterile

1500-02-000 Universal Tenodesis Procedure Pack, Sterile

1500-01-040 Cannulated Drill, 4 mm, Sterile

1500-01-050 Cannulated Acorn Reamer, 5 mm, Sterile





Part No. Description 1500-00-0410 Eclipse, 4 x 10 mm, with Disposable Gun

1500-00-0417 Eclipse, 4 x 17 mm, with Disposable Gun









eclipse general technique guide - medshape...dual-pronged tip of the fork, grasp the end of the...

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