SOS BAKRI TAMPONADE BALLOON CATHETER The Simple Solution for Postpartum Hemorrhage Illustration by...

SOS BAKRI TAMPONADE BALLOON CATHETER

The Simple Solution for Postpartum Hemorrhage

Illustration by Lisa Clark

SOS Bakri Tamponade Balloon Catheter

COOK® Ob/Gyn

Contents

• Discussion• Introduction• Indications• Steps for Balloon Application• Comparison to Existing Manual

Treatments• References• Support Info


COOK® Ob/Gyn

Discussion

• Postpartum hemorrhage (PPH) is defined as bleeding that occurs immediately after the placenta is delivered.

• PPH remains in the top five causes of maternal death in both developed and developing countries.


COOK® Ob/Gyn

Discussion

• PPH is an emergent situation. The decision for appropriate treatment must be made in a matter of minutes.

• Patients with PPH can deteriorate very quickly.


COOK® Ob/Gyn

Discussion

• Estimates of the incidence of PPH range from as few as 1:100 to as frequent as 1:20.

• The indications for use of the SOS Bakri Balloon Catheter are for temporary management of lower uterine segment bleeding.Indicated in about one third of all PPH cases.


COOK® Ob/Gyn

Introduction

• Various management measures are utilized for control of bleeding.– Uterotonics– Packing– Manual Compression– Embolization– Hysterectomy


COOK® Ob/Gyn

Introduction

• The ideal choice for managing a patient’s postpartum hemorrhage:– Easily administered and removed.– Control of capillary/venous bleeding and

surface oozing.– Ability to gauge success of treatment in real

time.– Avoid hysterectomy to preserve the

patient’s reproductive potential.


COOK® Ob/Gyn

Introduction

• The SOS Bakri Tamponade Balloon by Cook Ob/Gyn:– Easily administered– Quickly ascertain effectiveness.– Able to gauge ongoing blood-loss through

inner lumen.– Removes easily without need for separate

surgical procedure.– Conservatively manages hemorrhage.


COOK® Ob/Gyn

Indications

• The SOS Bakri Balloon catheter is intended to provide temporary control or reduction of postpartum uterine bleeding when conservative management is warranted.


COOK® Ob/Gyn

Indications

• While the device is intended as a temporary means of establishing hemostasis in cases indicating conservative management of postpartum uterine bleeding, the application of this device should be concomitant with close monitoring for signs of arterial bleeding, atony bleeding, and/or disseminated intravascular coagulation (DIC).


COOK® Ob/Gyn

Contraindications

• The use of this product is contraindicated in the presence of:– Arterial bleeding requiring surgical

exploration or angiographic embolization.

– Uterine atony bleeding.– Cases indicating hysterectomy.– Pregnancy


COOK® Ob/Gyn

Contraindications (cont.)

• The use of this product is contraindicated in the presence of:– Cervical cancer– Purulent infections of the vagina,

cervix, or uterus.– Untreated uterine anomaly.


COOK® Ob/Gyn

Contraindications (cont.)

• The use of this product is contraindicated in the presence of:– Disseminated intravascular

coagulation.– A surgical site which would prohibit

the device from effectively controlling bleeding.


COOK® Ob/Gyn

Application

Vaginal Delivery -- Transvaginal Placement:– Determine uterus is clear of any retained

placental fragments, arterial bleeding, or lacerations.

– Determine approximate uterine volume by ultrasound or direct examination.

– Insert the balloon portion of the catheter in the uterus, making certain that the entire balloon is inserted past the cervical canal and internal ostium, under ultrasound guidance.


COOK® Ob/Gyn

Application

Vaginal Delivery -- Transvaginal Placement (cont.): Note: Avoid excessive force when inserting the balloon into the uterus.

–If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output.–To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.


COOK® Ob/Gyn

Application

Cesarean Delivery -- Transabdominal Placement:

– Determine uterus is clear of any retained placental fragments, arterial bleeding, or lacerations.

– Determine uterine volume by intraoperative direct examination or postoperative ultrasound examination.


COOK® Ob/Gyn

Application

Cesarean Delivery -- Transabdominal Placement (cont.):

– From above (via access of the Cesarean incision), pass the tamponade balloon, inflation port first, through the uterus and cervix.

– Have an assistant pull the shaft of the balloon through the vaginal canal, until the deflated balloon base comes in contact with the internal cervical ostium.


COOK® Ob/Gyn

Application


–Close the incision per normal procedure, taking care to avoid puncturing the balloon while suturing.–If not already indwelling, place a Foley catheter in patient bladder to collect and monitor urine output.


COOK® Ob/Gyn

Application


–To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.


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ApplicationInstructions for Balloon Inflation• Note: Always inflate the balloon with sterile

liquid. Never inflate with air, carbon dioxide, or any other gas.

• Note: Do not over-inflate the balloon. Please refer to product label for maximum inflation volume.

– Ensure that indwelling Foley is placed in patient bladder at this time.


COOK® Ob/Gyn

Application

Instructions for Balloon Inflation (cont.)– To ensure that the balloon is filled to the desired

volume, it is recommended that the predetermined volume of fluid be placed in a separate container, rather than solely relying on a syringe count to verify the amount of fluid that has been instilled into the balloon.

– Using the enclosed syringe, begin filling the balloon to the predetermined volume through the stopcock.


COOK® Ob/Gyn

Application

Instructions for Balloon Inflation (cont.)– Apply gentle traction to the balloon shaft to ensure

proper contact between the balloon and tissue surface. To maintain tension, secure the balloon shaft to the patient’s leg or attach to a weight, not to exceed 500 grams.

• Note: If balloon becomes dislodged due to shaft tension and cervical dilation, deflate, reposition, and re-inflate. Use of vaginal packing may be indicated at that time to aid in balloon placement.


COOK® Ob/Gyn

Application

Patient Monitoring– Once balloon is placed and is inflated, connect the

drainage port to a fluid collection bag to monitor hemostasis.

• IMPORTANT: To adequately monitor hemostasis, the balloon drainage port and tubing should be flushed clear of clots with sterile isotonic saline.– Patient should be monitored continuously for signs

of increased bleeding, uterine cramping, or a deteriorating condition.

– Patient monitoring should include, but not be limited to: Blood pressure, pulse, urine output, cramping, pallor, and active bleeding.


COOK® Ob/Gyn

Application

Patient Monitoring (cont.)• IMPORTANT: Signs of deteriorating or

non-improving conditions should indicate more aggressive treatment and management of patient uterine bleeding.

• IMPORTANT: This device is not a substitute for surgical management and fluid resuscitation of life-threatening

postpartum hemorrhage.


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Application

Balloon Removal• Maximum indwell time is twenty-four (24)

hours. Balloon may be removed sooner upon physician determination of hemostasis or need to apply more aggressive treatment.– Remove tension from balloon shaft.– Remove any vaginal packing.– Using an appropriate syringe, aspirate the contents

of the balloon until fully deflated.– Gently retract the balloon from the uterus and

vaginal canal and discard.– Continue to monitor the patient for signs of uterine

bleeding.


COOK® Ob/Gyn

Comparison

Bakri Balloon• Bakri balloon comes packaged

with syringe, and stores like other surgical tools.

• May be applied quickly and easily.

• Open inner lumen allows for direct measurement of ongoing blood loss.

• Silastic balloon conforms to uterine cavity decreasing chance of uterine trauma.

• Can be removed quickly without additional invasive procedure.

Uterine Packing• Nominal Material Cost

• Possible concealed hemorrhage

• No record of blood loss

• Potential uterine trauma during application.

• Removal post-treatment can require an additional trip to OR.


COOK® Ob/Gyn

Comparison

Foley Catheters

• Inexpensive, but are generally ineffective in a large, postpartum uterine cavity.

• The application of multiple Foleys is cumbersome and less effective than the Bakri Balloon.

– If applied individually without an overbag, Foleys do not readily conform to uterine anatomy.

– Foley’s applied jointly in a plastic covering or overbag, do not allow for proper drainage, and can conceal uterine hemorrhage.

• Contains latex

• Not indicated for management of PPH.

Sengstaken-Blakemore Balloon

• This is a naso-gastric balloon for tamponade of esophageal varicoceles and the introduction of contrast media.

• Does not necessarily take uterine shape.

• Expensive

• Contains latex

• Not indicated for management of PPH.


COOK® Ob/Gyn


COOK® Ob/Gyn

SOS Bakri TamponadeBalloon Catheter

• 100% Silicon (no latex)• Ductile shape allows it to conform to uterine anatomy

and shape.• It allows for hemostatic cushion application, and limits

clot adhesion.• The large diameter lumen in the shaft and multi-ported,

non-abrasive tip allows for constant drainage, so an ongoing uterine hemorrhage does not go undetected post-application

• Once deflated the Bakri Balloon is easily removed trans-vaginally without the need for an additional surgical procedure.

• Approved by the FDA for specific application to postpartum hemorrhage.


COOK® Ob/Gyn

Primary References

• Bakri YN, et al. Tamponade-balloon for obstetrical bleeding. Int. J. Gynecol. Obstet. 2001; 74: 139-42.

• G. S. Condous, et al. The “Tamponade Test” in the Management of Massive Postpartum Hemorrhage. Obstetrics and Gynecology (2003) vol. 101, no. 4:767-772.


COOK® Ob/Gyn

Support

• FDA 510K Cleared:– #K013597– Tamponade Uterine Balloon Catheter Set– Regulation number: 21 CFR 884.4530– Regulation Name: Obstetric-gynecologic

specialized manual instrument– Class: II– Product Code: 85 KNA– Approval Date: March 6, 2002– Order Number: J-SOS-100500


COOK® Ob/Gyn

Contact

COOK® Medical Incorporated750 Daniels Way, P.O. Box 4195Bloomington, IN 47402-4195 U.S.A.Phone: 812 339-2235Toll Free: 800 541-5591Toll Free Fax: 800 837-4130

www.cookmedical.com

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