Search Results

The THD Procto Software System is a software that can be used: • In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image. • In Anoscopy exams, in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with an adequate resolution and their subsequent processing. • In anorectal manometry examinations, in order to view on a two-dimensional Pressure/Time graph the acquisition of the mean pressure signal transmitted by the THD Anopress device and subsequent processing (examination report and report printing) • Follow the clinical history, possible follow-ups of a patients

The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories and devices (endoanal probe, video camera and THD Anopress), is able to be applied for: - -Endoanal ultrasound (→ trans-rectal ultrasound / echography) - Anoscopy exams - -Manometry exams During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; During Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camero; During Manometry exams the THD Procto Software System allows the visualization and storage of patient data and examination results (anorectal manometry pressure values) as measured by THD Anopress device. The different modules and associated hardware devices cannot interfere with each other neither can work simultaneously.

The THD Procto Software is a software that can be used: · In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image. · In Anoscopy exams in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with a resolution greater than 1.1 MPx through USB protocol

The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories (endoanal probe and video camera), is able to be applied for: - Endoanal ultrasound (→ trans-rectal ultrasound / echography) - - -Anoscopy exams, During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; Durinq Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camera; The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below: - Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below - . Endoanal Ultrasound Module, which manages: - The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video - Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing, - The examination report (medical history, comments, conclusions) and the printing O - Anoscopy Exams module, which manages: - Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen - Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing - The examination report (medical history, comments, conclusions) and the printing o

The THD Anopress device must be used exclusively to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal on the specially designed THD Probes. THD Anopress must only be used by appropriately trained medical staff. Furthermore, the THD SensyProbe enables evaluation of rectal sensitivity and capacity and the ano-rectal inhibitory reflex through connection to a syringe and filling of the balloon on the probe with air. The THD Anopress with THD SensyProbe is intended to be used in adults only.

THD Anopress with THD SensyProbe is a handheld, portable anorectal manometry device for its use on patients requiring anorectal pressure studies and evaluation of functional rectal and pelvic diseases. The subject device consists of two main components: - . THD Anopress: This is the main unit with a keyboard for the selection of input command for pressure measurement and display for the visualization of detected pressure parameters in real time; - . THD Probes, grouped in THD PressProbe and THD SensyProbe - THD PressProbe is non-sterile disposable probe to be connected via the dedicated Luer-Lock connector to the THD Anopress. The probe is charged with air by the pump contained into the THD Anopress main unit and then is introduced into the anal canal of patient for the detection of pressure. - THD SensyProbe keeps the same characteristics of the THD PressProbe but it is additionally featured with a balloon positioned on the top of the introducer that is designed to be filled with air by the mean of a second inflation line and a Luer-Lock connection with a syringe. The inflation of the balloon with air allows the evaluation of the sensation thresholds of the lower rectum and to assess and trigger what is known as Recto Anal Inhibitory Reflex (RAIR). THD Anopress may be used in conjunction with a PC for data storage (not provided with THD Anopress). For this purpose, the PC requires installation of a dedicated program (Anopress SW) and the insertion of the Bluetooth Dongle accessory into the USB port. The Bluetooth dongle as well as Anopress SW are optionally provided by THD SpA. THD PressProbe membrane has a diameter varying from 14,4 mm (empty membrane) to 16,6 mm (membrane inflated to 150 mmHg). THD PressProbe is inflated to 150 mmHg, then it is inserted in the anal canal so that the sphincter exerts a compression on the membrane until 390 mmHg. THD SensyProbe membrane has the same diameter and performances as the THD PressProbe. The additional balloon positioned on the top of the introducer reaches a diameter of 70 mm when inflated with 200 ml of air. The allowed maximum inflation volume for distal end balloon is 180 ml of air.

The THD Anopress device must be used exclusively to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal on the specially designed THD Press Probe. THD Anopress may only be used by appropriately trained medical staff.

THD Anopress is a handheld, portable anorectal manometry device for measuring anal pressure, and especially the average sphincter tone, at the bedside on adult patients population. The subject device consists of two main components: - THD Anopress: This is the main unit with a keyboard for the selection of input command for pressure measurement and display for the visualization of detected pressure parameters in real time; - THD Press Probe: This is a non-sterile disposable probe to be connected via the dedicated Luer-Lock connector to the THD Anopress. The probe is charged with air by the pump contained into the THD Anopress main unit and then is introduced into the anal canal of patient for the detection of pressure. THD Anopress may be used in conjunction with a PC for data storage (not provided with THD Anopress). For this purpose, the PC requires installation of a dedicated program (Anopress SW) and the insertion of the Bluetooth Dongle accessory into the USB port. The Bluetooth dongle as well as Anopress SW are optionally provided by THD SpA THD PressProbe membrane has a diameter varying from 14,4 mm (empty membrane) to 16,6 mm (membrane inflated to 150 mmHg). THD Press Probe is inflated to 150 mmHg, then it is inserted in the anal so that the sphincter exerts a compression on the membrane until 390mmHg.

The THD Revolution is intended to be used for the surgical treatment of hemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique. The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits. THD Revolution and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorroidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD Revolution, it can be used in modality "Light Source", to support the different THD diagnostic devices.

Identically to the predicate devices K090009, K081429 e K070815, the THD Revolution is a 8 MHz continuous wave (CW) Doppler detector with a loudspeaker and a light source. Further, as the predicate device, the THD Revolution doppler is used with dedicated accessories (optical fiber and pneumatic foot pedal) and a dedicated kit containing a proctoscope, needle holder, knot tightener, sutures, doppler probe and Surgy proctoscope in order to allow the surgical operation through the Transanal Hemorroidal Dearterialization (THD) technique.

The THD N-Ano Anoscopes, are intended for physician use to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.

The disposable, not sterile THD N-ano anoscope is a disposable, not sterile anoscope with an integrated LED light source. The device is designed for the examination o the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures. The light source is integrated on the handle. Differently than predicate devices (Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope - K103647) disposable, not sterile THD N-ano Anoscope does not have any accessory and is available only "not sterile"

The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures by using additional accessories.

The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope are disposable, sterile rectoscopes, proctoscope and anoscopes with a light source which can be external or integrated on the handle. The devices are designed for the examination and treatment of anus (anoscopes) and the examination of rectum (proctoscopes and rectoscopes). The devices consist of plastic anoscopes, proctoscopes for diagnostic or therapeutic use. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctoscopes and Rectoscopes and Surgical Proctoscopes. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope includes both models which require the external light source and models which not require the external light source. In the latter case the light source is integrated on the handle. The external light source is provided as an accessory of the device family and it can be the THD Shining Light and the THD pen light.

The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope are disposable not sterile rectoscopes, proctoscopes and anoscopes with a light source external or integrated on the handle. The devices are designed for the examination and treatment of the anal (anoscopes) and rectum (proctoscopes and rectoscopes) examination. The devices consist of transparent plastic anoscope, proctoscope or rectoscope for diagnostic or therapeutic use. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctocope and Rectoscope and Surgical Proctoscopes. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope include both models which require the external light source and models which not require the external light source, in this case the light source is integrated on the handle. The external light source is provided as accessory of the family and it can be the THD Shining Light and the THD pen light.

The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.

The THD Bandy is an hemorthoidal ligator intended for pinching off hemorrhoidal nodule. The device is to be used in combination with a suction device, mounted on the basis of the THD Bandy. The THD Bandy consists of a ligation unit, a pusher and a cone. The ligation unit consists of a cylindrical housing connected with a trigger for the release of the elastic band or of the ligature. The hemorrhoidal nodule, trapped on the distal portion of the device, receive an elastic ring or a ligature in order to cut off the blood flow. The pusher and the cylindrical cone are provided in order to assist in the loading of the bands.

The family of THD disposable Anoscope, Proctoscope and Rectoscope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The family of THD Disposable Anoscope, Proctoscope and Rectoscope are designed for the examination and treatment of the anal (anoscope) and recturn (proctoscope and rectoscope) examination. The devices consist of transparent plastic anoscope. proctoscope or rectoscope for diagnostic or therapeutic use. The family of THD disposable Anoscopes, Proctoscopes and Rectoscope is made by 2 categories of devices: Diagnostic Anoscopes, Proctoscopes and Rectoscope and Surgical Proctoscopes. The family of THD disposable Anoscopes, Proctoscopes and Rectoscope consist of the evolution of the family of THD disposable Anoscope and proctoscope previously cleared (K080132). As in the previous submission, this family is provided with two accessories for illumination the "Shining Light" and the "pen light".