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The SIB Catheter is intended for the delivery of diagnostic contrast media agents into the female reproductive tract for examination of the uterus

The SIB Catheter consists of a 5 F balloon catheter with a single lumen polyurethane shaft with an end hole. The balloon inflates upon infusion of contrast media into the uterus. Increasing the infusion rate will cause the balloon to grow thereby occluding the cervical canal. Cessation of saline injection will cause the balloon to collapse.

Procedure trays containing components intended for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes (i.e. Hysterosalpingography or Hysterosonography).

The H/S Procedure Tray, Elliptosphere Procedure Tray and Multi-Purpose Tray contain components that can be used for conducting either Hysterosalpinography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and falopian tubes using ultrasound sonography). All components are provided sterile for single use only.

The H/S Catheter Set is used for the delivery of diagnostic contrast media agents in the female reproductive tract for examination of the uterus and fallopian tubes.

The H/S Catheter Set can be used for conducting either Hysterosalpingography (examination of the uterus and fallopian tubes using x-rays) or Hysterosonography (examination of the uterus and fallopian tubes using ultrasound sonography). All components are provided sterile for single use only.

Injection of saline in the examination of the uterus using ultrasound techniques.

The Tampa Hysterosonography set will consist of two parts: a single lumen catheter and a semi-rigid introducing sheath. The catheter will be available in a 5-French diameter with a length of 33 cm. The distal end will have either a side port or end port. The proximal end will be fitted with a female luer-lock hub. The catheter will be banded with non-toxic ink 7 cm. from the distal tip. The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and a wall thickness sufficient to provide semi-rigid flexibility. It is 16 cm. long, and flanged and rounded at the distal end to provide a non-traumatic surface to the tissues. The proximal end allows for temporary fixation over the proximal hub of the catheter.

The Modified Hysterosalpingography Set is to be used for the injection of contrast material in the examination of the uterus and fallopian tubes.

The Modified Hysterosalpingography Set consists of three parts: a double-lumen, balloon bearing catheter; a semirigid placement sheath, and a syringe to inflate the balloon. The double-lumen catheter will be available in two diameters, 5F and 7F, and is composed of a radiopaque flexible plastic tube 30cm. long. The distal end will have either a side port or end port. The balloon which is composed of a synthetic elastomer of a natural, clear polyurethane material is mounted 5 to 8 mm proximal to the The proximal end of the catheter is composed distal end. of a fitting leading to a bifurcation; one extension is for balloon inflation, the other for contrast injection. The semi-rigid sheath has an internal diameter to allow easy movement over the catheter and an outside diameter The length sufficient to provide semi-rigid flexibility. The distal end is flanged to provide a smooth is 20cm. non-traumatic surface to the tissues. The syringe is either a 3cc or 6cc size for the 5F or 7F catheter, respectively. The 3cc syringe has a vent at the 1.5cc graduation providing that volume for inflation of The recommended volume for the 7F balloon the 5F balloon. is 4.0cc.

The Ackrad IUI Set is intended for use in cases where the recipient has had difficulty in achieving pregnancy in the customary way.

The Ackrad IUI Set consists of two parts: a calibrating probe and an introducing catheter, each of which is accompanied by a placement sheath to aid in insertion. The calibrating probe is a clear flexible tube, closed and rounded at the distal tip. A movable stop is attached to assist in calibrating the depth of insertion. Five narrow bands, one cm apart, designate distances of 25, 26, 27, 28 and 29cm from the distal tip, with a wide band at 30cm from the tip. The proximal end is fitted with a two-cm length of large outside diameter tubing to serve as a handle. The diameter of the probe is 1.8 mm and the working length is 44.0 cm. The introducing catheter is identical to the calibrating probe except that the distal end has an end port or side port within 3 mm of the tip, and the proximal end is fitted with a standard female luer-lock hub. Both the probe and the catheter are composed of clear, naturally flexible polyurethane material. The movable stop is composed of clear polyvinyl chloride of a 55-60A durometer. Both the calibration probe and the catheter have a placement sheath through which they pass as an aid in insertion. The sheath is composed of rigid polypropylene material, 20 cm long with an inside diameter of 3.4 mm and an outside diameter of 4.6 mm. The distal end is rounded to minimize trauma. The ink used for the banding of the catheter and probe is No-tox no. M-1000, manufactured by the Colorcon Corp. of West Point, PA. The device functions as a means of accurately injecting the sperm into the uterus of the receptor patient. The calibrating probe is first used to measure the proper depth for insertion. Then sperm is introduced into the uterus via the catheter and expelled at the proper depth. The placement sheath allows both the probe and the catheter to be advanced through the cervix of the patient easily and non-traumatically without buckling or inadvertently touching the vagina.