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The Aqueduct 200 Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

The Aqueduct 200 Cervical Dilation Balloon Catheter is a balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The subject device is an updated version of the Aqueduct 100 Cervical Dilation Balloon Catheter cleared under K160664 that merges two separate dilation balloons into one balloon, removes the anchor balloon, replaces the four-way hub with a three-way hub, and removes the stylet from the shaft. The catheter consists of a 2-lumen shaft. One lumen inflates a cylindrical dilation balloon. A second lumen is for infusion of saline solution and also contains a camera and camera cable. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. Using visual feedback from the forward-looking camera and LED light source the physician advances the catheter through the cervical canal and identifies the end of the canal when entering the internal orifice of the uterus. When the physician identifies the orifice, the catheter is positioned inside the cervix. This aligns the cylindrical dilation balloon at the internal cervical os and external cervical os. The balloon is inflated with 12.5 ml of saline, providing gradual mechanical dilation of the cervix. The camera cable on the catheter connects to a camera module that provides power to the camera and allows connection to an HDMI port on a monitor to assess proper device placement during a clinical procedure. After 3 minutes of dilation of the internal and external orifices of the uterus, a controlled injection of 1-2.5 ml of saline may be made through the catheter infusion lumen which exits on the distal end of the catheter. Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed exiting through the external opening of the cervix. Optimal dilation of 8-9 mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes. The deflation of the balloon is conducted by attaching a luer lock syringe to the swabable valve and removing saline from the balloon. The subject device is packaged in a mylar/Tyvek pouch and ethylene oxide (EO) sterilized to a SAL 10-6. The packaged device has a shelf-life of 15 months.

The Aqueduct 100 Plus Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

The Aqueduct 100 Plus Cervical Dilation Balloon Catheter is a balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The subject device is an updated version of the Aqueduct 100 Cervical Dilation Balloon Catheter cleared under K160664 that merges two separate dilation balloons into one balloon, removes the anchor balloon, replaces the four-way hub with a three-way hub, and removes the stylet from the shaft. The catheter consists of a 2-lumen shaft. One lumen inflates a cylindrical dilation balloon. A second lumen is for infusion of saline solution. In use, the catheter is inserted through the vagina and cervical canal and into the uterus. The catheter is positioned inside the cervix. The user aligns the cylindrical balloon at the internal cervical os and external cervical os. The balloon is inflated with 12.5 ml of saline, providing gradual mechanical dilation of the cervix. After 3 minutes of dilation of the internal and external orifices of the uterus, a controlled injection of 1-2.5 ml of saline may be made through the catheter infusion lumen which exits on the distal end of the catheter. Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed exiting through the external opening of the cervix. Optimal dilation of 8-9 mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes. The deflation of the balloon is conducted by attaching a luer lock syringe to the swabable valve and removing saline from the balloon. The subject device is packaged in a mylar/Tyvek pouch and ethylene oxide (EO) sterilized to a SAL 10-6. The packaged device has a shelf-life of 15 months.

The CrossBay™ Cervical Dilator Catheter System is intended to be used whenever cervical softening and dilation is desired. Some examples are: - Treatment of cervical stenosis - IUD placement and removal - Placement of instruments for intrauterine radiotherapy - Endometrial biopsy - Global endometrial ablation - Uterine tissue removal - Uterine curettage - Diagnostic hysteroscopy - Operative hysteroscopy This device is not intended for use in the induction of labor.

The CrossBay Cervical Dilator Catheter System is a sterile, single use device composed of an inflation device, dilator catheter, everting membrane, and dilator balloon which enable softening and dilation of the cervical canal. The CrossBay Cervical Dilator Catheter System contains an Inflation Device and a Dilator Catheter that accesses the cervix using a hydraulic pressure-filled everting Membrane. The Inflation Device provides the hydraulic energy with saline supplied by the user. Once placed at the exocervix, the Dilator Catheter advances through the cervix by everting the Membrane through the endocervix. A Dilator Balloon is attached to the inner tube of the device that is positioned across the cervix when the everting Membrane is fully everted. The Inflation Device is then used to further pressurize the system to split open the everting Membrane to expose the Dilating Balloon. The Inflation Device is used to pressurize the Dilator Balloon to the prescribed level. Once dilated, the Dilator Catheter is removed from the cervix and the subsequent uterine cavity procedure can commence. The CrossBay Cervical Dilator Catheter with Dilator Balloon is provided in three sizes of 5mm, 7mm, and 9mm. The three sizes are identical except for the diameter of the Dilator Balloon when pressurized.

The Aqueduct 100 Cervical Dilation Balloon Catheter is intended to be used whenever cervical softening and dilation is desired. Some examples are: treatment of cervical stenosis, IUD placement and removal, Radium placement, drainage of uterine cavity, endometrial biopsy, uterine curettage, suction cannula aspiration, operative hysteroscopy.

The Aqueduct 100 Cervical Dilator is a triple-balloon cervical dilation catheter which enables the simultaneous dilation of both sides of the cervical canal. The catheter consists of a 3-lumen shaft. One lumen inflates an anchoring balloon. A second lumen inflates the 2 cylindrical dilation balloons. The third lumen is for infusion of saline solution and also contains a fixed stiffening stylet to add rigidity to the catheter. The stylet is permanently sealed within the infusion lumen. In use, the catheter is inserted through the vagina and cervical canal and into the uterus where the distal spherical balloon is inflated. The catheter is then withdrawn until the spherical balloon comes into contact with the internal orifice of the uterus, which positions and anchors the catheter within the cervix. This aligns the two cylindrical balloons at the internal cervical os and external cervical os. The balloons are inflated with saline providing gradual mechanical dilation of the cervix. After 3 minutes of dilation of the internal and external orifices of the uterus, a gentle, controlled injection of 1ml, and up to 2.5ml, of saline can be made through the catheter infusion lumen which exits between the two balloons (and inside the cervical canal). Evidence that cervical dilation is complete can be determined once droplets of the saline injection are observed entering through the external opening of the cervix. Optimal dilation of 8-9mm within the cervical canal is typically achieved following 5 minutes of balloon dilation. The entire procedure from catheter insertion to removal is completed in 6-7 minutes. The Aqueduct 100 Cervical Dilator is packaged in a mylar/Tyvek pouch and EO sterilized to SAL 10-6.

The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone. The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.

Dilapan-S is to be used whenever cervical softening and dilation is desired. Some examples are: - 1. Cervical stenosis - a. related to dysmenorrhea - b. considered a possible cause of infertility - c. resulting from cauterization or conization - 2. Placement and removal of intrauterine devices - 3. Induction of labor - 4. Radium placement - 5. Drainage of uterine cavity - 6. Endometrial biopsy - 7. Uterine curettage - 8. Suction cannula aspiration - 9. Operative hysteroscopy

DILAPAN-S is a hygroscopic cervical dilator that is manufactured from AQUACRYL, a proprietary hydrogel. The dilators are firm hygroscopic rods, similar in shape to natural laminaria tents. DILAPAN-S is capable of increasing in diameter on average from three (3) millimeters to 8.3-10 mm, or four (4) millimeters to 10-12.5 millimeters within 4-6 hours as they absorb moisture from the genital tract. In clinical trials, DILAPAN-S has been shown to dilate the cervix gradually. It may not be necessary to use general or local anesthetics during the insertion process, thereby eliminating their associated risks to the patient. A Marker String is tied securely to the handle of the DILAPAN - S, and is provided to indicate location. DILAPAN-S is capable of increasing its volume as it absorbs moisture from the genital tract through hygroscopic action. The volume of DILAPAN-S subsequently exerts radial pressure on the surrounding structures (uterine neck) to dilate progressively. Endocervical pressure on the uterine neck results in mechanical dilation and promotes cervical ripening through reversible cell dehydration and local endogenous prostaglandins release promoting collagen reorganization. DILAPAN-S is available in boxes of 10 or 25 dilators and in the following dimensions: 4mm x 65mm, 4mm x 55mm, 3mm x 55mm. Each DILAPAN - S is individually wrapped in a single foil pouch and is sterilized by gamma radiation.

The Cook® Cervical Ripening Balloon is indicated for mechanical dilation of the cervical canal prior to labor induction at term when the cervix is unfavorable for induction.

The Cook® Cervical Ripening Balloon is a double-balloon catheter designed to mechanically ripen the cervix prior to labor induction at term when the cervix is unfavorable for induction. The tip of the Cook® Cervical Ripening Balloon is placed through the vagina and the cervical canal into the uterus. The distal balloon is positioned against the internal cervical os and inflated with up to 80 mL of saline; the proximal balloon is positioned against the external cervical os and also inflated with up to 80 mL of saline. The Cook Cervical Ripening Balloon provides gradual mechanical cervical dilation by simultaneously providing pressure on the internal and external cervical os. In addition to the standard version, the Cook® Cervical Ripening Balloon is also available with a removable stylet to add rigidity to the catheter and aid in placement of the balloon through the cervix. The stylet runs the length of the catheter shaft of the Cook® Cervical Ripening Balloon in a separate lumen that is closed at the distal tip. The user removes the stylet from the device once the distal uterine balloon is above the level of the internal cervical os.

The Atad Pre-Induction Cervical Dilator is indicated for mechanical dilation of the cervical canal prior to labor induction a term when the cervix is unfavorable for induction.

The Atad Dilator is an 18Fr, 400mm, natural latex, three-lumen, double latex balloon catheter with a corresponding valve for each balloon and a disabled third lumen that is not intended to be used.

Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as Uterine curettage, Labor induction, IUD placement and removal, and Radium placement

This single use device is a hygroscopic laminaria cervical dilator designed to dilate (stretch open) the cervical os by cervical insertion of a cylindrical and expansible material into the cervical canal, made from the root of a seaweed (laminaria digitata). Laminaria expands when it absorbs moisture. The ability to increase in size slowly (usually 6 to 24 hours) is of advantage in physiologically dilating a closed body orifice such as the cervical canal. When used improperly, it may cause the patient major discomfort or uterine complications Laminaria is available in 2, 3, 4, 5, 6, 7, 8 and 9 mm diameter sizes with a length varving between 50 and 65 mm. Each laminaria is drilled and attached to a 75-95 mm string to facilitate removal from the cervical canal (the last digit of the product code reflects its size) Laminaria is intended for use whenever it is desirable to dilate the cervical canal, such as uterine or suction curettage, labor induction, IUD placement and removal, and Radium placement