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Lipocast Biotech UK Lipogems Equine Standard Operating Procedure 007 - without videos

Lipogems Equine & Lipogems Canine
17 de Oct de 2017
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Lipocast Biotech UK Lipogems Equine Standard Operating Procedure 007 - without videos

  1. AUTOLOGOUS – SAFE – STERILE – ENZYME-FREE – SUSTANIBLE – SHARI’AH COMPLIANCE – CLINICALLY TESTED ENGINEERING CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. Lipocast Biotech UK Ltd Standard Operating Procedure for Lipogems Equine
  2. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. Part 1 – Set up Part 2 – Restraint and sedation of the horse Part 3 – Select site for adipose extraction Part 4 – Preparing the Lipogems kit Part 5 – Prepare the saline Part 6 – Making the incision Part 7 – Infiltration of the subcutaneous tissue Part 8 – Attaching the 13G cannula Part 9 – Pulling the plunger fully out Part 10 – Harvesting 15-30ml Part 11 – Leave the harvested material to stand vertically This set of instructions covers the clinical use of the Lipogems adipose processing system for use in therapy of equines. A power point presentation of this SOP with additional demonstration videos is also available. The instructions are divided into the following steps: Part 12 – Surgical skin preparation for treatment site Part 13 – Connect saline to Lipogems and remove air bubbles Part 14 – Attach 50ml syringe to connector Part 15 – Cleaning the lipoaspirate Part 16 – Concentrate the Lipogems Part 17 - Making the final surgical preparation Part 18 – Bandage using sterile dressing Do’s & Don’ts
  3. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. • Drugs for sedation, e.g. detomidine and butorphanol • 100 ml lignocaine/adrenaline solution (2% lidocaine and 0.002% adrenaline/epinephrine) • 1 x 500 ml bag of normal saline (0.9%) and 1 x 3 L bag of the same (or 2 x 2 L) • Local anaesthetic (mepivicaine 2%, 10-50 ml) for regional analgesia of limb prior to injection of tendon/ligament • Assorted syringes and needles (minimum 1 x 50 ml, 2 x 2 ml, 5 x10 ml, 18, 20, 21, 22 G needles), • Scalpel blade (#11 or 15) • Surgical scrub (povidone iodine) and spirit • Surgical (sterile) gloves • Sterile drape Part I Setup - You will need in addition to the Lipogems kit
  4. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. • Restrain the horse – preferably hand held by a competent groom or assistant • Sedate the horse - drugs for sedation; e.g. detomidine and butorphanol While it is not essential to have the horse in stocks, as the lipoaspiration procedure is well tolerated by the majority of patients, it may help in fractious horses or where the site to be infiltrated with Lipogems necessitates good restraint Part 2 – Restraint and sedation of the horse
  5. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. • Select site for adipose extraction using transcutaneous ultrasonography • The recommended site is around the tail head • Clip a square (approximately 5 x 5 cm) of hair 21 cm distant to this (we recommend dorsolaterally to the deepest fat tissue), approximately 13 cm from the midline on both sides of the tail head • Place a 2 ml bleb of local anaesthetic under the skin in the centre of this square and prepare the skin aseptically Part 3 - Select site for adipose extraction
  6. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. Part 4 – Preparing the Lipogems kit Open the Lipogems kit and lay out the cannulae and syringes and transfer the devices onto a sterile drape
  7. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. • Add 50 ml of local anaesthetic (2% lidocaine and 0.002% adrenaline/epinephrine) to a 500 ml bag of sterile normal saline • Fill the 50 ml syringes with the resulting solution Part 5 - Prepare the saline
  8. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. • Clip the area for the incision • Prepare the incision area with surgical scrub (povidone iodine) and spirit • Make a stab incision in centre of one patch of clipped and scrubbed skin with a No.15 scalpel blade Part 6 – Making the incision
  9. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. • Using the 20G cannula infiltrate the subcutaneous tissue in the region of deepest adipose tissue with 150 ml local anaesthetic/saline solution. This should fan out from the tail head towards the ischial tuberosity • Repeat on the other side of the tail head Part 7 - Infiltration of the subcutaneous tissue
  10. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. Part 8 - Attach 13G cannula and move whilst under vacuum • Attach the 13G cannula to the Vaclock syringe and insert subcutaneously towards the area infiltrated with saline/local anaesthetic • Pull the plunger half way and lock • Move the cannula backwards and forwards (as if you were playing a violin) • Taking care not let the cannula exit and lose vacuum
  11. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •As the Vaclock syringe fills, pull the plunger fully out and lock •Once full, transfer the contents to a 50ml syringe, which should be held vertically with the nozzle pointing downwards •The lipoaspirate will then float upwards •The underlying aqueous solution should be discarded •It is not necessary to staple the stab incisions at harvest sites Part 9 - Pulling the plunger fully out
  12. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •Repeat until it is no longer possible to aspirate solution from the site •Repeat at the second site on the other side of the tail head •You should aim to harvest 15-30 ml of lipoaspirate from each site Part 10 - Harvesting 15-30ml
  13. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. Once the aspiration procedure has been completed leave the harvested material to stand in one or more vertically held 50 ml syringes. Part 11 - Leave the harvested material to stand vertically
  14. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •Ready the site for infiltration by clipping hair •Place nerve blocks or other regional anaesthesia •Initial surgical skin preparation Part 12 - Surgical skin preparation for treatment site
  15. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •Tie a 3ltr bag of normal saline at head height and connect the Lipogems device. •With the grey end upper most allow saline to fill the chamber and display air. • If an air bubble remains, close the inlet clips and attach a 10 ml luer lock syringe to both the grey and blue ends of the canister •Draw 10 ml saline into the syringe on the blue end and close the inlet clip. With the air bubble in the centre of the uppermost grey filter rapidly inject the 10ml of saline to recover air in the upper syringe •Repeat until all air bubbles have been extracted and remove the 10 ml syringe •NB. THERE MUST BE NO AIR BUBBLES Part 13 - Connect saline to Lipogems and remove air bubbles
  16. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •Turn the device through 180 degrees so that the blue end is now uppermost •Take the 50 ml syringe containing lipoaspirate, eject any aqueous tissue, and attach to the connector blue end •Open the outlet clip and inject slowly taking care that fatty tissue does not extend beyond the ‘S’ in ‘LIPOGEMS’ on the side of the canister Part 14 - Attach 50ml syringe to connector
  17. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •Remove the 50 ml syringe and open the inlet clip and wash the lipoaspirate for around 45 seconds •Close the outlet then inlet clip and shake in a vertical motion for 15 seconds •Open inlet and then outlet clips and wash again for 45 seconds •Repeat cycles of shaking and washing until there are no traces of blood or aqueous material and only a clean lipoaspirate remains Part 15 – Cleaning the lipoaspirate
  18. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •With the grey end upper most, attach 10 ml luer lock syringes at both ends of the canister and open the inlet clip •Fill the syringe on the blue end with 10 ml saline and close the inlet clip. This should then be rapidly injected into the canister so that the Lipogems is ejected into the upper syringe •Repeat until all of the Lipogems have been extracted. By holding the harvest syringes vertically aqueous solution can be ejected and the Lipogems concentrated Part 16 - Concentrate the Lipogems
  19. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. Transfer Lipogems to 1 ml syringes for infiltration Make the final surgical preparation of the site for infiltration and inject Lipogems observing aspetic precausions Part 17 - Making the final surgical preparation
  20. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. When structures of the lower limb have been infiltrated bandage the limb using a sterile dressing over the site Following up: The horse or pony should be on box rest for 5 weeks or in a small coral if a stable is not an option. Ideally a pressure bandage should be applied during this time where possible. Scans should follow at 5 weeks before walk work and fitness plans are implemented. Part 18 - Bandage using sterile dressing
  21. CONFIDENTIAL: FOR INTERNAL USE ONLY. DO NOT DISTRIBUTE. •Don’t make the stab incision for harvesting too large as this will allow air to enter and ruin vacuum pressure •Do try to avoid contaminating the lipoaspirate with muscle •Do allow harvested lipoaspirate to stand so that aqueous infranatant can be discarded prior to microfracturing •Do ensure effective analgesia of any tendon/ligament to be injected – do this immediately after collection so that the ‘block can take’ while the lipoaspirate is being processed •Do eliminate all air from the Lipogems device, including the bubble in the giving set •Remember to harvest Lipogems with the grey end of the device uppermost •Do allow Lipogems to stand so that remaining aqueous infranatant can be discarded prior to injection •Inject Lipogems using a 1 ml luer lock syringe with a 20/21/22 G needle. Using a larger syringe and needle actually makes it more difficult to inject due to greater hydraulic pressures within the syringe •Administer NSAIDs for 5-7 days after the procedure Lipogems – Do’s & Don'ts
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