Memory Staple. Surgical Technique

Transcription

1 Memory Staple Surgical Technique

2 Contents Product The Memory Staple is an ideal form of fixation for arthrodesis, osteotomy and fracture fixation. Made from Nitinol memory alloy, the BioPro Memory Staple is fully activated at 98.6 F (37 C), patient body temperature. Table of contents Indications & Contraindications 1 Implant Specifications 2 Instrument Specifications 3-4 Handling Instructions 5 Surgical Technique 6-8 Common Procedures 9 Implant Ordering 10 Instrument Ordering 11 Contact information Website: info@bioproimplants.com orders@bioproimplants.com Phone: (810) Fax: (810) Address: 2929 Lapeer Rd, Port Huron, MI 48060

3 Indications & Contraindications Indications for use: 1. Hand and foot bone fragment and osteotomy fixation and joint arthrodesis. Contraindications: 1. Comminuted bone surface which would militate against staple placement. 2. Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the staple. 3. Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation. Warning: Immobilization in addition to this internal fixation until bone healing should be achieved by routine methods (casting, splints, etc.) Reduction of the site should be achieved and maintained prior to implanting the staple. The compressive force of the staple closing should not be relied upon to achieve closure or reduction of the fracture line. This staple system has not been evaluated for safety and compatibility in the MR environment and has not been tested for heating or migration in the MR environment. Care and Caution: Inspect the sterile blisters used for the implants prior to use. Sterilization cannot be assured and staple should not be used if blister or seal is damaged. Staples should be stored at 75º F (24 C) or less. Staples should be cooled to 75º F (24 C) prior to removing from the shipping block. Placing staples at -4 F ( -20ºC) will return them to their original position. The staples are a single use device. Do not autoclave staples. Adverse Effects: Allergic reactions to metal (titanium or nickel) Delayed or Non-union of bone Delayed Healing Staples may break Staples may extruded or back out of the surgical site 1

4 Implant Specifications Bridge Width The Memory Staple is available in 17 standard sizes. Standard leg staples are utilized when a flush surface exists while the offset staples offer different leg lengths to accommodate uneven bone surfaces. Leg Length The S-Bend bridge of the Memory Staple ensures even compression across the fusion site, while maintaining a low profile against the bone. The Memory Staple is manufactured from Nitinol, a memory alloy. The staple will begin activation at 75 F (23.9 C) and is fully activated at 98.6 F (37 C), patient body temperature. This provides dynamic compression during the healing process. Bridge Width Wire Size Standard Legs Leg Length Wire Size 7mm 5mm 1.2mm 7mm 5mm 1.5mm 9mm 7mm 1.2mm 9mm 7mm 1.5mm 11mm 8mm 1.5mm 11mm 10mm 1.5mm 13mm 10mm 1.5mm 15mm 12mm 1.5mm 15mm 12mm 2.0mm 20mm 20mm 2.0mm 20mm 20mm 2.0x3.0mm 25mm 22mm 2.0x3.0mm 30mm 30mm 2.0x3.0mm Bridge Width Leg Length A Leg Length B Bridge Width Leg Length A Offset Legs Leg Length B Wire Size 11mm 15mm 13mm 1.5mm 11mm 17mm 15mm 1.5mm 11mm 19mm 17mm 1.5mm 18mm 18mm 15mm 2.0mm Wire Size 2

5 Instrument Specifications Adjustable drill guide An adjustable drill guide (ref 17681) is included in the instrument kit (ref 17707). The drill guide accommodates every staple size. Set the adjustable drill guide by pulling down on the set pin (green arrow), with the set pin pulled down slide the top guide bar (blue arrow) until the desired staple bridge width shows in the engraving window. 3

6 Instrument Specifications Single hole drill guide One single hole drill guide (ref 17656) and three angled drill guides (ref 17648/17649/17650) offer additional options during limited exposure procedures. 1.2MM 5mm Drill bits Ø1.4mm,1.8mm, 2.4mm, 3.0mm color coded drill bits are included in the instrument tray. The drill bits feature etched lines that indicate drill depth. 1.5MM 2.0MM 7mm 19mm 12mm 5mm 15mm 8mm 18mm 12mm Note: Etched lines only correlate with the adjustable drill guide and single hole drill guide. 3.0MM 20mm 15mm 22mm 30mm 20mm Instrument kit Instrument kit (ref 17707) includes all of the necessary instruments for implantation of any staple size. 4

7 Handling Instructions It is important to always handle the staple with hemostats, never by hand as this may result in premature activation. The instrument kit includes specially designed hemostats to securely handle all sizes of the Memory Staple. 5

8 Surgical Technique Step One: Prepare the surgical site and determine optimal staple size. Note The adjustable drill guide can act as a sizer when determining the correct staple size. (Fig 1) Fig 1 Step Two: Utilizing a provided drill guide, drill the distal hole. (Fig 2) Fig 2 6

9 Step Three: Insert the provided anchor pin in the distal hole to maintain position; drill the proximal hole. (Fig 3) Fig 3 Step Four: Utilizing a pair of hemostats, place the staple into the predrilled holes. (Fig 4) Caution It is important that the staple is always handled with hemostats, never by hand, as this may result in premature activation. Fig 4 7

10 Step Five: Use the appropriate size staple punch to ensure the staple is fully inserted and seated against the bone. (Fig 5) Fig 5 Step Six: After insertion, the staple should sit flush against the bone. (Fig 6) Staple compression will occur at body temperature, but may be hastened by irrigation with saline 98 F (37 C) to 100 F (38 C). Fig 6 8

11 Common Procedures Foot and Ankle: 1. Hallux IP Fusion: 9x7,11x8,11x10,13x10 2. Hallux MPJ Fusion: 13x10,15x12,18x18x15 3. Lesser PIPJ Fusion: 7x5, 9x7 4. Distal Metatarsal Osteotomies: 11x10,13x10x11x15x13 5. Base Wedge Osteotomies: 11x10,13x10,15x12, 18x18x15 6. Akin Osteotomies: 7x5 1.2mm,9x7 1.2mm 7. Cotton Procedure: 20x20,18x18x15 8. Lapidus Procedure 20x20,18x18x15 Dorsally / 15x12 Medially 9. Talonavicular Fusion: 18x18x15,20x Calcaneal Cuboid Fusion: 15x12,18x18x15,20x Dwyer Osteotomy: 20x20 Hand and Wrist: 1. DIP Fusion: 7x5,9x7 2. PIP Fusion: 7x5,9x7 3. MCP Fusion: 11x8,11x10,13x10 4. Capitate/Scaphoid Fusion: 11x8,11x10,13x10 5. Capitate/Lunate Fusion: 11x8,11x10,13x10 6. CMC Thumb Fusion: 11x8,11x10,13x10 7. Third Metacarpal/Capitate Fusion: 11x8,11x10, 13x10 8. Fifth Metacarpal/Hamate Fusion: 11x8, 11x10, 13x

12 Implant Ordering Standard Legs Bridge Width Leg Length Wire Size Drill Ø Color Code Item # 7mm 5mm 1.2mm 1.4mm Blue mm 5mm 1.5mm 1.8mm Green mm 7mm 1.2mm 1.4mm Blue mm 7mm 1.5mm 1.8mm Green mm 8mm 1.5mm 1.8mm Green mm 10mm 1.5mm 1.8mm Green mm 10mm 1.5mm 1.8mm Green mm 12mm 1.5mm 1.8mm Green mm 12mm 2.0mm 2.4mm Yellow mm 20mm 2.0mm 2.4mm Yellow mm 20mm 2.0x3.0mm 3.0mm Purple mm 22mm 2.0x3.0mm 3.0mm Purple mm 30mm 2.0x3.0mm 3.0mm Purple Offset Legs Bridge Width Leg Length A Leg Length B Wire Size Drill Ø Color Code Item # 11mm 15mm 13mm 1.5mm 1.8mm Green mm 17mm 15mm 1.5mm 1.8mm Green mm 19mm 17mm 1.5mm 1.8mm Green mm 18mm 15mm 2.0mm 2.4mm Yellow

13 Instrument Ordering ITEM # DESCRIPTION MEMORY STAPLE COMPLETE KIT ANCHOR PIN ANGLED STAPLE PUNCH LARGE STAPLE PUNCH SMALL STAPLE PUNCH LARGE STAPLE CLAMP SM STAPLE 4 3/4 BULLDOG HEMOSTAT DRILL GUIDE ADJUSTABLE DRILL GUIDE SINGLE HOLE DRILL GUIDE 7-9MM DRILL GUIDE 11-13MM DRILL GUIDE 15-18MM DRILL BIT XSM - 1.4MM DRILL BIT SM - 1.8MM DRILL BIT MD - 2.4MM DRILL BIT LG - 3.0MM MEMORY STAPLE INSTRUMENT TRAY 11

14 Notes

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16 Lapeer Road Port Huron, MI MKT24 00