Uterine manipulator Hystero-Swing®

Description
The instrument is designed for uterus manipulation. This handling allows to reach in complete safety the posterior cul-de-sac of Douglas and protects the surrounding vital organs (ureters, bladder, rectum…). Moreover, the particular shape of its bodies helps avoid carbonic gas leakage, differentiating it from other uterine manipulators.

Surgical excision with cervix removal

• Initially designed for complete hysterectomy, the Hystero-Swing® perfectly suits this intervention and especially for difficult cases, such as cervix cancer.

Surgical excision with preservation of the cervix

• Use of the Hystero-Swing® is extended to other interventions: supra-cervical hysterectomy, prolapse, colpotomies, cervix cancers, endometriosis of the recto-vaginal wall.

Assembly
The Hystero-Swing® is general-purpose and can be adapted to uterine anatomy. Before any operation, two measurements are necessary for appropriate use:

• 1 / Selection of the body's diameter
• 2 / Selection of the endo-uterine stem

Measurement and selection

• Selection of the body's diameter depends on the vaginal gauge; calibration is carried out with a speculum to visualize vaginal diameter and choose one of the three available sizes (Ø32, Ø36, Ø40 mm).
• Selection of the stem length is made after using a graduated hysterometer. Before introducing the endo-uterine stem, expand the uterus with a 6 mm Hegar’s bougie. Stem selection should follow the provided length table and be adjusted according to user experience.

Operating technique - assembly steps

• 1 / Assemble the suitable body by aligning the arrows (sealing washer optional) and attach the removable prehension handle.
• 2 / Insert the handling axis from the proximal side of the removable prehension handle.
• 3 / Assemble cervix washer only, or cervical screw with cervix washer depending on the operation. Turn the cervical screw to assemble the main handling axis through the cervix washer when required.
• 4 / Complete assembly with the appropriate stem determined by hysterometry.
• 5 / Before positioning, grease the body with sterile Vaseline to avoid vaginal tissue drying. Fastening is made with speculum and Pozzi clamp on the uterine cervix; insert the stem in the cervical canal while shifting the speculum, then introduce the body after withdrawal of the speculum.

Indications
The device is indicated for laparoscopic total hysterectomy (including complicated cases such as Douglas occlusions from pelvi-peritonitis sequelae, cesarean section antecedents, Wertheim intervention). It enables wide section of utero-sacral ligaments, protects the vaginal barrel, and facilitates visualization and internal division of the vagina for hemostasis near the ureters.

Prolapse and posterior colpotomy

• For prolapse (gynecological and digestive surgery): isolated rectoceles, complicated prolapses with cystoceles, rectoceles and elytroceles. The complete Hystero-Swing® is assembled without the cervical screw but with the cervix washer to present the retro-uterine cup and aid peritoneum dissection and levator ani opening.
• Posterior extractive colpotomy: assembled without cervical screw but with cervix washer to present the posterior vaginal wall safely.

Surgical treatment of rectovaginal wall endometriosis

• For uterine conservation, assemble the complete Hystero-Swing® without cervical screw but with the cervix stop joint washer.

Sub-total hysterectomy

• Assemble without cervical screw and cervix washer. Withdraw the Hystero-Swing® before section with diathermy knife.

Notes and warnings
In all cases the instrument is normally assembled with a cervical screw except for cancer cases where a uterine cervix stop joint washer without cervical screw must be used to avoid histological damage. When the cervix is gaping, use the cervical screw and cervix stop joint washer to avoid uterine perforation. It is recommended to choose an adapted stem length according to cavity measurement. General recommendations for cleaning, decontamination and sterilization are listed in the instructions for use according to DGS/R13/2011/449. WARNINGS: Avoid prolonged contact (electrical or ultrasonic bistoury) with the body of the uterine manipulator as prolonged contact can cause damage to the body.

References

• HYST02 — Complete uterine manipulator
• HYBC02 — Storage container and lid
• CA 045-40-01 + CI 520-10-09 — Third Arm and GEO-LOCK holder

Caractéristiques / spécifications techniques

• Commercial name: Hystero-Swing®
• Brand: THT bio-science
• Intended use: uterine manipulation for laparoscopic hysterectomy and related gynecological procedures (hysterectomy, prolapse repair, colpotomy, treatment of rectovaginal endometriosis, etc.)
• Available body diameters: Ø32 mm, Ø36 mm, Ø40 mm
• Stem selection: determined by hysterometry; uterus expanded with 6 mm Hegar’s bougie before stem insertion
• Assembly components: body (interchangeable), removable prehension handle, handling axis, cervical screw, cervix stop joint washer, optional sealing washer
• Recommended lubrication before positioning: sterile Vaseline
• Fastening method: speculum and Pozzi clamp on the uterine cervix
• Device references: HYST02 (complete device); HYBC02 (storage container and lid); CA 045-40-01 + CI 520-10-09 (accessories)
• Medical device classification: Class I medical device
• Cleaning/sterilization: follow instructions for use per DGS/R13/2011/449
• Warnings: avoid prolonged contact with electric/ultrasonic bistoury; withdraw device before diathermy knife; specific assembly rules for cancer cases to avoid histological damage and to prevent uterine perforation when cervix is gaping