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DSI PhysioTel Digital Manual

Blood pressure and biopotential telemetry devices
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PhysioTel®Digital Device
Surgical Manual
Surgical Implantation of the PhysioTel®Digital Blood
Pressure and Biopotential Telemetry Devices
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Summary of Contents for DSI PhysioTel Digital

  • Page 1 PhysioTel®Digital Device Surgical Manual Surgical Implantation of the PhysioTel®Digital Blood Pressure and Biopotential Telemetry Devices Error! No text of specified style in document.  1 Doc-To-Help Standard Template...
  • Page 2 Copyright 2012 Data Sciences International All Rights Reserved Printed in U.S.A. Part Number Rev. 01 Data Sciences International (DSI) 119 14th Street NW ● Suite 100 ● St. Paul, MN 55112 Telephone: (1-651) 481-7400 ● 1-800 262-9687 Fax: (1-651) 481-7417 Website: www.datasci.com...
  • Page 3 Introduction PhysioTel®Digital telemetry devices are surgically implanted into large laboratory animals to acquire multiple types of physiologic measurements, process the information and transmit the data via radio-frequency signals. The PhysioTel®Digital device can measure pressure (such as systemic blood pressure or intra-ventricular pressure), a biopotential (such as ECG) temperature and physical activity.
  • Page 4 o Trans-diaphragmatic Approach o Intercostal Thoracotomy Approach  Solid Tip ECG Lead Placement o Internal Jugular Vein o External Jugular Vein  Traditional ECG Lead Placement o Lead II o Base-Apex  Appendix A: Additional Device Information  Appendix B: Functional Specifications ...
  • Page 5 Required Supplies for the PhysioTel®Digital Surgery EQUIPMENT  Clippers  Supplemental heating  PhysioTel®Digital device  Ponemah 5.1 data collection system  Mechanical ventilator INSTRUMENTS  Details contained in Appendix D SUPPLIES  Surgical scrub (Chlorhexidine or Providine-Iodine scrub)  Sterile drapes ...
  • Page 6  Magnet *  Re-gel syringe  Vetbond ® Tissue adhesive (if placing systemic blood pressure catheter in iliac artery)  Gel loading micropipette tip or insulin syringe (if placing systemic blood pressure catheter in iliac artery) * Contained in starter kit Error! No text of specified style in document.
  • Page 7 For additional help in determining an appropriate anesthetic protocol, the staff veterinarian should be contacted. DSI has also prepared an Anesthesia Reference Manual as a guide to assist in choosing an appropriate anesthetic agent for a wide variety of common laboratory species.

  • Page 8: Device Description

    Peri-operative Antibiotics and Antiarrhythmic Medications The use of antibiotics may be elected at the discretion of the investigator. The combination of sterile device packaging and proper aseptic technique help increase the potential for successful surgical outcomes. Investigators should follow the guidelines of their own institution.
  • Page 9  Thin-walled section: tip of the catheter farthest from the device body that senses the dynamic portion of the pressure wave. It is designed to be completely inserted into the vessel or space where the desired pressure can be sensed. It contains biocompatible gel at the very tip, which prevents the non-compressible fluid from leaving the catheter and blood from clotting in the catheter tip (see Figure2).
  • Page 10 Biopotential Leads - Two silicon coated helices of medical grade stainless steel wire extending out of the device body. The positive (red) lead is designed to be cut to a length suitable for the biopotential signal to be monitored. The negative (clear) lead has a solid tip and is NOT meant to be cut (unless you require traditional lead placement).
  • Page 11 Also doDo not discard the sterile package as it can be used for eventual return of the device to DSI. 2. Place the device and catheter into a sterile basin with sterile saline warmed to body temperature. Do not heat the sterile saline higher than body temperature as this can result in clotting at the catheter tip once it is placed in the animal.
  • Page 12 Preoperative Patient Preparation Administer the appropriate surgical anesthesia. Apply Artificial Tears eye ointment to each eye. Remove the body hair liberally from all intended incision sites. Surgically scrub the incision sites with Chlorhexidine or Providine-iodine scrub. a. A series of at least three scrubs after all gross debris has been removed is recommended.
  • Page 13 Device Implantation Site Selection The PhysioTel®Digital device can be implanted either intramuscularly, subcutaneously, intraperitoneally or subperitoneally in animals weighing at least 2.5 kilograms. Possible locations for placement of the device body vary with the species and size of animal that is implanted and the physiologic parameters that will be measured.
  • Page 14 Intra-abdominal Placement: Intraperitoneal/Subperitoneal Intraperitoneal/subperitoneal placement is appropriate for canines and non-human primates weighing ≥ 2.5 kg. Due to potential device engulfment by the intestines, intraperitoneal placement is not recommended in swine; instead a modified subperitoneal approach is favored. The intraperitoneal/subperitoneal placement is particularly useful when the trans- diaphragmatic approach is used to access the heart for left ventricular pressure catheter placement, since access to the peritoneal cavity will have already been established.
  • Page 15 the device is placed on the left side of the alba the antennae will run along the linea alba the antennae will run along the abdominal wall, across the abdominal abdominal wall, across the abdominal incision, towards the right side of the incision, towards the right side of the abdomen.) abdomen.)
  • Page 16 Figure 7. PhysioTel®Digital Device Placed Intraperitoneally [MES11] 11. Next a small pocket should be tunneled in the subperitioneal space using blunt dissection with a mayo scissors or a straight hemostat to provide a secure location for the antenna to sit. 12.
  • Page 17 Subcutaneous Intramuscular 2a. Using a mayo scissors bluntly dissect 2b. Using a gridding technique, bluntly under the skin to form a pocket separate the superficial external abdominal approximately the size of the device body. oblique muscle along the fibers running craniodorsal to caudoventrally.
  • Page 18 placement of the antenna should also be closed using an intradermal/subcuticular pattern. Dorsal Recumbency Figure 11. Subcutaneous/Intramuscular Placement in Dorsal Recumbency Intramuscular Subcutaneous 1a. Place a longitudinal incision just axial (to 1b. Place a longitudinal incision just abaxial the inside of) the fold of the flank. Make the (to the outside of) the fold of the flank.
  • Page 19 of the heart. Remembering that during small nick in the intercostals muscles, being dorsal recumbency the animal’s heart very careful to center the incision midway shifts from its natural position so the between the cranial and caudal rib; this incision should be placed slightly prevents trauma to the intercostals nerve ventrally.
  • Page 20 4. Carefully remove the tip cover from the LV catheter (Channel 1, see description above). Removal of the tip cover should be done by alternating gentle traction and release. Take care to prevent gel loss due to compression of the catheter or sudden release of the tip cover.
  • Page 21 Figure 15: Puncture the heart wall 8. Withdraw the needle and insert a micro-mosquito hemostat into the hole. Open the hemostat slightly to expand the hole. 9. Grasp the overlap section of the catheter using a Ddebakey forceps, vessel cannulation forceps or gently using the hand.
  • Page 22 Figure 17: Left ventricular pressure signal 12. Once proper positioning is verified, draw the purse-string suture closed around the catheter. Ensure this suture is tight and multiple square knots are tied to prevent the catheter from withdrawing from the heart (see Figure 18). Figure 18.
  • Page 23 13. Tie one tail of each of the purse-string sutures to one tail of each of the suture aid sutures (this is why using different colored sutures can be helpful) to further secure the catheter in place. 14. Ensure that the catheter is placed securely in the heart wall and that all bleeding has stopped, and cut the stay suture aid suture and purse string suture tails.
  • Page 24 of the diaphragm closed. 19a. Make sure there are no leaks in the 19b. Next the muscle layers of the incision diaphragmatic closure, and that the should be closed in multiple discrete layers diaphragm maintains its concave using 2-0 to 4-0 absorbable suture material appearance following catheter removal.
  • Page 25 Figure 20. Medial Saphenous Artery Exposure [MES14] Mesenteric Artery Medial Saphenous/Femoral Artery 1a. Locate an intestinal artery running 1b. The pulse of the medial saphenous through the mesentery closely associated artery can be palpated on the inside of the with the vein and lymphatic vessel. Choose thigh with the hindlimb extended straight out an artery that has nearby collateral blood behind the animal and rotated externally so...
  • Page 26 sutures can be tied in loose knots to allow the suture to pass as it is inserted into the abdominal aorta. The proximal-most suture will be used to temporarily occlude blood flow when the artery is punctured (see Figure 21). Figure 21.
  • Page 27 6. Gently and slowly remove the tip cover using gentle traction and release, without touching the distal thin-walled sensing portion of the catheter. Take care to prevent gel loss due to compression of the catheter or sudden release of the tip cover. Always examine the catheter prior to implantation for gel loss or bubbles.
  • Page 28 1. Carefully locate and isolate the iliac artery. The paired iliac arteries are located in the caudal abdomen and branch directly off of the caudal abdominal aorta and can be palpated by first detecting the aortic pulse and moving caudally (see Figure 25). Figure 25.
  • Page 29 4. Fill four gel-loading micropipette tips with Vetbond tissue adhesive using capillary action and set aside. They will be used to dispense a very small amount of adhesive to seal the vessel. Using micropipettes to dispense the Vetbond will help control the amount of Vetbond applied to the artery.
  • Page 30 11. Secure the catheter that is outside the vessel near the entry site to the lumbar muscles in at least two locations using non-absorbable suture. If the catheter is not secured to nearby muscles there is a high risk that the catheter will back out of the vessel post- operatively, which would result in internal bleeding and loss of the blood pressure signal.
  • Page 31 nearby muscles there is a high risk that the catheter will back out of the vessel post- operatively, which would result in internal bleeding and loss of the blood pressure signal. Electrocardiogram (ECG) Lead Placement Positive Lead Placement The positive lead must be placed first so you can detect an ECG signal to guide placement of the negative solid tip lead.
  • Page 32 Figure 30. Lead II ECG Placement Figure 31. Base-apex ECG Lead Placement 1c. If the positive ECG lead will be placed epicardially, it will need to be directed to the thoracic cavity and placed prior to closure of the chest following left ventricular pressure catheter ±...
  • Page 33 Figure 32. ECG Lead Modification 3. Take the suture still attached to the ECG lead and use this to tack the loop to the underlying muscle/tissue. Anchor the exposed portion of the lead to the underlying muscle using at least 3 simple interrupted knots using 2-0 to 0 3-0 non-absorbable suture. You can also tack the lead along its course if you are concerned about tension.
  • Page 34 Figure 33. External Jugular Vein Figure 34. Internal Jugular Vein in Non-human Primate 2. Once the solid-tipped lead is exteriorized at the jugular incision via passing it through a cannula (as described above in device placement description), it’s time to prepare the vessel for cannulation.
  • Page 35 6. It is imperative to monitor the ECG signal while passing the negative lead. The appropriate location of the solid tip is dictated by the size of the P wave. The P wave will start out small and grow increasingly larger as it approaches the heart and may become negative when it is passed too far.

  • Page 36: Appendix A: Additional Device Information

    If the catheter must be cut, the device cannot be reused. Clean and sterilize the device with an approved enzyme detergent and sterilant before returning the device to DSI. For complete information on products and techniques approved for use with DSI devices, visit www.datasci.com. Product Return Information A detailed procedure for properly returning telemetry devices to DSI for exchange is provided on our website, www.datasci.com.

  • Page 37: Appendix B: Functional Specifications

    Appendix B: Functional Specifications Specifications PhysioTel®Digital Device Weight Volume Height Width Length Usable Catheter 35 cm*** Length Catheter Diameter Temperature Range Pressure Range Initial Accuracy Battery Life Intended Cage Size * Standard catheter length. Also available in 10 cm and 15 cm lengths. ** The diameter is 5.5 cm and the thickness is 1.5 cm.

  • Page 38: Appendix C: Device Care And Use Operational Modes

    Prior to returning TL devices for refurbishment we ask that they are cleaned and sterilized. For complete and current information on products and techniques approved for use with DSI devices, visit www.datasci.com Storage Storage of New Devices Carefully examine all devices when they arrive at your facility. Remove the packages containing the devices from the shipping boxes.
  • Page 39 Storage of On-Site Sterilized Devices Occasionally there may be a delay between the device removal from the animal and return to DSI for refurbishment. Proper storage of the on-site sterilized device is necessary to ensure that the unit will not be damaged.

  • Page 40: Appendix D: Equipment And Supplies

    Appendix D: Equipment and Supplies The surgical instruments, along with their part numbers from Fine Science Tools, are listed below. Part Number Description 11006-12 Adson Forceps-straight, serrated 11027-12 Adson-Brown Tissue Forceps-straight, with teeth 13019-14 Kelly Hemostat Forceps, curved 13018-14 Kelly Hemostat Forceps, straight 13009-12 Halsted Mosquito Forceps, curved 13008-12...
  • Page 41 Gel-loading micropipette tips (Part Number 02-707-83) can also be purchased from Fisher Scientific. Fisher Scientific: Telephone: (1-800) 766-7000 Fax: (1-800) 926-1166 Website: www.fishersci.com Error! No text of specified style in document.  41 Doc-To-Help Standard Template...

  • Page 42: Appendix E: Checking The Offset Of A Pressure Device

    Assign each device to a receiver, enter the calibration information, and assign an animal ID for each device through the Edit DSI Setup from the Hardware menu. Select the appropriate animal ID from the Select DSI Sources from the Hardware menu.
  • Page 43 After the device has been on for 1-4 hours, place the device in the packaging tray onto its assigned receiver. From the Setup menu, choose PD Setup... and change the analysis module to BP for the pressure channel in the Channel Input Setup screen. Close the Setup window and start an acquisition from Acquisition –...