DSI PhysioTel Digital User Manual

PhysioTel®Digital Device

Surgical Manual

Surgical Implantation of the PhysioTel®Digital Blood

Pressure and Biopotential Telemetry Devices

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Acknowledgments
Vetbond® and Bair Hugger® are registered trademarks of 3M.

PhysioTel®Digital Device Surgical Manual

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: [phone] ● 1-800 262-9687

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Fax: [phone]

Website: www.datasci.com

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. This manual contains detailed procedures
for implantation of the TS-L11 and TS-L21 PhysioTel®Digital telemetry devices. The
techniques described are designed for large laboratory animals including dogs, primates
and swine but may be applicable to other, similar sized animals.

The PhysioTel®Digital Device Surgical Manual is intended for use by laboratory personnel
who will perform or assist in surgical procedures to implant PhysioTel®Digital devices. The
surgical procedures written in this manual are at a level of detail appropriate for persons
who have previous experience with surgical procedures. These devices should only be
implanted by a person who has previous surgical experience.

WARNING: The PhysioTel®Digital implantable device is not intended for use in humans. It
is a misuse of this device, and a possible violation of law, to use these devices in humans.

This Manual Contains the Following Sections:

 Required Supplies for the TS-L11 and TS-L21 Surgery
 Anesthesia and Analgesia Guidelines
 Peri-operative Antibiotics
 Device Description
 Surgical Preparation
 Device Handling
 Device Placement

o Intra-abdominal placement

 Intraperitoneal
 Subperitoneal

o Extra-abdominal placement

 Intramuscular
 Subcutaneous

 Systemic Blood Pressure Catheter Placement

o Mesenteric Artery
o Medial Saphenous/Femoral Artery
o Iliac Artery
o Thoracic Aorta

 Left Ventricular Pressure Catheter Placement

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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
 Appendix C: Care and Use
 Appendix D: Equipment and Supplies
 Appendix E: Checking the Offset of a Pressure Device

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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
 Sterile gloves, hair bonnet and face mask
 Sterile surgical gown
 Sterile gauze sponges-4 inches x 4 inches (10 cm x 10 cm)
 Sterile saline
 Sterile basin
 2% Lidocaine
 Elastic vessel loops
 2-0 * to 4-0 (Smaller or larger suture may be needed depending on size and species

used) non-absorbable, non swaged suture[MES1]

 2-0 to 4-0 (Smaller or larger suture may be needed depending on size and species

used) non-absorbable suture swaged on a tapered needle[MES2]

 2-0 or 4-0 (Smaller suture may be needed depending on size and species used)

absorbable suture material swaged on a tapered needle[MES3]

 2-0 to 4-0 (Smaller suture may be needed depending on size and species used)

absorbable surgical suture swaged on a cutting needle[MES4]

 14-gauge hypodermic needle *
 20-gauge hypodermic needle *
 Catheter introducer (i.e. vein pick)*

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 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

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Anesthesia and Analgesia Guidelines

Proper peri-operative pain control and anesthesia are critical to humane treatment of
laboratory animals. Each institution’s staff veterinarian should be contacted for proper
analgesic and anesthetic protocols and training before survival surgery is attempted.

The use of pre- and post-surgical analgesics is strongly encouraged for all surgical

manipulations performed on laboratory animals. “The proper use of anesthetics and
analgesics in research animals is an ethical imperative…The selection of the most

appropriate analgesic or anesthetic should reflect professional judgment as to which best
meets clinical and humane requirements without compromising the scientific aspects of the

research protocol.”

staff veterinarian.
Typically, the surgical procedure for the TS-L11 will require 60 minutes of surgical

anesthesia, and the surgical procedure for the TS-L21 device will require approximately
120 minutes of surgical anesthesia. Intermittent positive pressure mechanical ventilation is
required any time the thoracic cavity is opened, such as during placement of a left
ventricular pressure catheter. Appropriate use of this technique is essential, and should be
directed by the staff veterinarian. The surgical procedures described in this manual were
developed using inhalational anesthesia consisting of Isoflurane delivered in 100% Oxygen.
These recommendations are intended as a guide only and should be modified to the
individual animal and institution’s protocol.

1

Questions regarding the use of analgesics should be directed to your

Anesthetized animals are predisposed to hypothermia. The use of supplemental heat
sources such as warm water re-circulating heating pads or Bair Huggers® are important to
maintain baseline body temperature. Hypothermia will prolong the recovery period and may
result in animal loss.

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.

1

Guide for the Care and Use of Laboratory Animals, NRC, National Academy Press, 1996 [MES5]

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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. Questions regarding the use of antibiotics should be directed to the institution’s
staff veterinarian.

Due to the manipulation of the heart, there is a potential to induce an arrhythmia, and the
anesthetist may wish to be prepared to deliver antiarrhythmic agents as appropriate. The

choice and dose of agents should be determined through consultation with the institution’s

veterinarian.

Device Description

It is important that you are familiar with the device and its function before you attempt
implantation (see Figure 1).

Figure 1. PhysioTel®Digital Device[MES6]

The PhysioTel®Digital device measures pressure, a biopotential signal, temperature, and
physical activity in primates, dogs and swine and is a rectangular shaped device.

The devices consist of the following major components:

Device Body - The titanium housing containing:

 Pressure sensor: receives pressure fluctuations from the fluid-filled catheter

and sends the signals to the electronics module.

 Reusable electronics module: translates the pressure fluctuations,

biopotential signal and temperature into digitized signals and transmits them
to a receiver. It also interprets signals received from the laboratory software

and contains a magnetically activated switch that allows the device to be

switched on or off.

 Battery: provides the power supply for the electronics module.
 Suture aid: allows the surgeon to suture the device securely in place at the

implant site.

Pressure Catheter(s) - Polyurethane tubing that extends (25, 35 or 40 cm) out of the
device body and contains:

 Non-compressible fluid: relays pressure fluctuations to the sensor in the device

body.

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 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).

 Tip cover: removable section of silicone tubing that protects the catheter tip until it is

actually inserted into the desired vessel. Must be removed prior to catheter insertion.

 Systemic blood pressure catheter: containing a radio-opaque ring encircling the

distal end of the systemic blood pressure catheter (This is the channel 2 catheter on
the TS-L21 PhysioTel®Digital Device.)

 Left ventricular pressure catheter: containing a plastic suture collar near the tip, with

only the thin-walled section protruding beyond. The white suture collar will be
inserted until the suture groove is flush with the heart wall (see Figure 3).

It is important to be familiar with the catheter and its features. See the figure below for a
detailed diagram of each catheter.

Figure 2. The PhysioTel®Digital catheter

Figure 3. The Left Ventricular Catheter Tip With Collar[MES7]

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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). It is designed
to be introduced into the right jugular vein and fed into the cranial vena cava to collect the
ECG signal.

 Silicone tubing: provides insulation from external electrical activity.
 Solid tip on the negative lead: senses ECG signal within the vena cava, near the

base of the heart.

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Figure 4. [MES8]Solid Tip Biopotential Lead

Device Handling

ALWAYS handle the device with care supporting both the device body
and catheters from underneath when moving or placing the device.
Allowing the catheters to hit a solid surface can damage the pressure
sensor.

Before removing the device from its sterile package

Turn the device to the ON mode with a magnet and audibly verify proper device operation
with a DSI receiver.

1. Record the serial number of the device and ensure that the device has been identified
with the animal into which it will be implanted.

2. Measure and record the pressure offset. Refer to Appendix E for further information on

this process.

To Hydrate the Catheter

1. Open the sterile package by peeling back the white package cover from the clear plastic
tray. Do not discard the white package cover as it contains important device calibration

information. 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.

3. The catheter should be hydrated for approximately 30 minutes before implantation.

Note: The catheter is very hydrophilic and, if not hydrated, will absorb water from
the blood. This can cause the gel to recede due to catheter expansion and leave a
void at the tip of the catheter, which could increase the risk of blood clot
formation.

WARNING: Do NOT use surgical electrocautery on the animal once the
device is on the surgical tableimplanted into the animal. Use of
electrocautery once the ECG leads are implanted will cause failure of the
device!

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Preoperative Patient Preparation

1. Administer the appropriate surgical anesthesia.

2. Apply Artificial Tears eye ointment to each eye.

3. Remove the body hair liberally from all intended incision sites.

4. 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.

b. Begin each scrub in the center of the scrubbed area, over the planned incision

site, and scrub in a ‘bulls eye’ pattern toward the periphery, never going back to

the center with the same gauze sponge. The skin preparation should be
thorough but gentle to avoid unnecessary skin trauma.

c. The final application of scrub may be allowed to remain on the skin.

5. Once the animal and the surgeon have been prepped for surgery and a sterile field has

been established, the surgery is ready to begin.

For intra-thoracic procedures, the animal must be placed on a ventilator to maintain
respiration.

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Device Implantation

Device Body

Location

Dog

NHPs

Swine

Peritoneal cavity;

sutured to the inner

abdominal wall

Acceptable location

Acceptable location
(NHP must be > 2.5

kg)

Not recommended

Peritoneal cavity;

sutured between

the peritoneum and

the abdominal wall

muscles

Acceptable location

Acceptable location
(NHP must be > 2.5

kg)

Acceptable location

Intramuscularly

along the animal’s

flank

Acceptable location

Acceptable location

Acceptable location

Subcutaneously

along the dorsum or

flank

Acceptable location

Not recommended

Not recommended

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.

If core body temperature measurements are desired, the device must be placed in the
peritoneal cavity or subperitoneally (between the peritoneum and the abdominal muscle).
Direct placement of the device body in the abdomen of swine is not recommended due to
rare cases of engulfment and ingestion of the device by the swine’s gastrointestinal tract,.

Ttherefore subperitoneal placement is recommended in this species.

Other possible locations for placement of the device body include intramuscularly along the
animal’s flank or subcutaneously along the dorsum or the flank. Subcutaneous placement
is not generally recommended in pigs and NHPs since they are prone to picking and
rubbing the device when it is placed in this location.

For subcutaneous and intramuscular locations, the animal must be large enough to allow
the antennae to lie perpendicular to the device body to preserve signal quality and in
location that is not directly over bone since this can lead to skin necrosis and irritation. The
device must lie flat under the skin in a pocket that is large enough to accommodate the
device comfortably. However excessive pocket size predisposes to seroma formation.

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