Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/0291—Instruments for taking cell samples or for biopsy for uterus
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/0045—Devices for taking samples of body liquids
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
  • A61M25/0026—Multi-lumen catheters with stationary elements
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/007—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests for contrast media
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/3148—Means for causing or aiding aspiration or plunger retraction
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
  • A61M5/178—Syringes
  • A61M5/31—Details
  • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
  • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/10—Balloon catheters
  • A61M2025/1043—Balloon catheters with special features or adapted for special applications
  • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body

Definitions

• the present invention relates to a catheter, in particular to a balloon bearing three lumen catheter for simultaneous dispensing diagnostic fluids into a body cavity and retrieving a sample of the diagnostic fluid at the same time and a catheter apparatus employing same.
• Ovarian cancer is the leading cause of death from gynecologic malignancy in western civilized countries, with an estimated prevalence in Europe and the U.S.A. of 752,600 in 2007 and 59,828 deaths yearly.
• Treatment and survival of the patients depend primarily on the stage of the disease. Of all ovarian cancer patients only 25% are diagnosed at an early stage while the tumor is confined to the pelvis. In these cases the five-year survival rate is 80% to 90% and the disease can often be cured by the combination of surgery and chemotherapy and are increasingly frequently referred to as type I ovarian cancer.
• hysterosalpingography is a radiographic method for imaging the anatomical structures of the uterus and fallopian tubes.
• Hysterosalpingography involves inserting a fine flexible catheter through the cervical canal and injecting a contrast medium, such as an iodinated fluid, into the uterus. Radiography is then carried out to provide imaging information pertaining to the subject uterus.
• a contrast medium such as an iodinated fluid
• saline contrast hysterosonography Another well-known diagnostic procedure which entails the non-surgical entry into the uterus is called saline contrast hysterosonography.
• This procedure also employs a fine flexible catheter that is inserted into the cervical canal of the uterus.
• the catheter in this procedure enables the physician or technician to inject a sterile saline solution into the uterus to expand it so that an ultrasound scanner can be used to sonographically observe the uterus.
• the uterine cavity is in a sense a virtual space, because the anterior and posterior walls of the uterus are in direct contact to each other. Particularly in postmenopausal but also in non-pregnant premenopausal women the body of uterus containing the uterine cavity is very small.
• the cavity itself has a triangular shape measuring only app. 3 cm in length and app. 2 cm at the roof.
• a fluid gets dispensed into the cavity, it immediately evacuates through the fallopian tubes into the peritoneal cavity and the dispensed fluid cannot be retrieved anymore.
• the opening of catheters tend to get obstructed by loose tissue from the lining of the cavity called endometrium or by blood clots frequently present in the uterine cavity.
• a catheter is desired that has a very short tip to fit into the small space of the uterine cavity, that allows for simultaneous flushing of fluid into the uterine cavity and proximal tubes and aspirating the fluid at the same time, preventing the fluid to evacuate through the fallopian tubes.
• the channels should have more than one opening ideally pointing into different directions.
• a small balloon would be desirable.
• WO03033045 discloses a catheter with suction capability to obtain a biosample.
• the catheter is designed for collecting prostatic fluid from the prostatic urethra and/or the membranous urethra.
• the catheter exhibits biosample entry ports (25) which are positioned along the elongated body.
• the catheter has a urinary drainage port (26). Therefore, the catheter according to WO03033045 is not suitable to simultaneously dispense a diagnostic fluid and retrieve a sample of the dispensed fluid at once.
• PCT/EP2013/051899 discloses a non-invasive method for the diagnosis of adenocarcinoma or their precursor lesions of ovaries, fallopian tubes and endometrial lining in a female subject by analyzing cells of said subject wherein a uterine catheter designed for non-invasive rinsing of the uterine cavity and collecting a sample of the rinse.
• catheters of this design have a closed tip which makes it difficult to retrieve a sample of the dispensed fluid, representing a lavage of the fallopian tubes and uterus. Therefore, a catheter which allows for simple and reproducible retrieving a sample from the dispensed fluid is desirable.
• the catheter comprises an elongated body having two single lumens extending continuously from a proximal end up to the top of the tip at the distal end and a third lumen extending continuously from the proximal end to an inflatable balloon.
• Fig. 1 a and 1 b are a view of the catheter.
• Fig. 2a, b, c, and d are detailed sections of the tip.
• Fig. 3 is a view of the connecting element.
• Fig. 4 is a view of the proximal end of the catheter.
• Fig. 5 is a view of an applicator assembly.
• Fig. 6 is a view of two syringes fixed in the applicator assembly.
• Fig. 7 is a view of the applicator assembly with an adapter.
• Fig. 8 is a view of applicator assembly with the adapter and a lip.
• the present invention relates to a catheter useful for non-surgical entry into a uterus to dispense a diagnostic fluid therein and to retrieve simultaneously a sample from said dispensed fluid representing a lavage of the fallopian tubes and uterus, the catheter comprises:
• a balloon (9) disposed marginally adjacent to the distal end (3) of the elongated body (1 ) for fluid sealing the interior of the subject's uterus;
• lumens (4 and 5) extend from the proximal end (2) up to the distal end (3) of the elongated body
• lumen (6) extends from the proximal end (2) to the distal end (3) with an opening that lies proximally from the distal end (3) for inflating the balloon (9), and lumen (4) has an opening (4') at the top of the tip for dispensing a diagnostic fluid into the interior of a subject's uterus and tubes, and
• lumen (5) has an opening (5') at the top of the tip for retrieving a sample of said dispensed fluid of the interior of a subject's uterus representing a lavage of the fallopian tubes and uterus simultaneously.
• An embodiment of the invention is the catheter as described above, wherein the lumens (4 and 5) have additionally side openings (8) between the top of the tip and the balloon.
• a further embodiment of the invention is the catheter as described above, wherein the lumens (4 and 5) have connecting means for connecting syringes.
• a further embodiment of the invention is the catheter as described above, wherein the third lumen has a closure device (10) at the proximal end (2) for closing the lumen upon filling the balloon with said closure device at the proximal end.
• a further embodiment of the invention is the catheter as described above, wherein said closure device (10) is a blocking valve.
• a further embodiment of the invention is a kit for dispensing a diagnostic fluid and to retrieve a sample from the dispensed fluid from a subject's uterus, comprising - a catheter as described above,
• a further embodiment of the invention is the kit as described above, wherein said adapter has a lip (19).
• a further embodiment of the invention is the use of a kit as described above for screening a female population being at risk of endometrial cancer or suffering from premalignant changes of the endometrium or endometrial cancer.
• a further embodiment of the invention is the use of a kit as described above for screening a female population being at risk of ovarian cancer or suffering from premalignant changes of the ovary or ovarian cancer.
• a further embodiment of the invention is the use of a kit as described above for screening a female population being at risk of cancer of the fallopian tube or suffering from premalignant changes of the tube or tubal cancer.
• a further embodiment of the invention is a non-invasive method of collecting a sample for ex vivo diagnostic purposes by rinsing the uterine cavity and optionally the fallopian tubes of a subject with a lavage fluid and retrieving a cell sample from the rinse.
• Fig. 1 a and 1 b show a catheter with an elongated body (1 ) and three internal lumens (4, 5 and 6).
• Two lumens (4 and 5) extend to the distal end of the elongated body (1 ) with openings (4' and 5') at the top of the tip at the distal end.
• distal end refers to the end furthest from the person holding the apparatus
• proximal end refers to the end closest to the holder of the apparatus.
• the lumens (4 and 5) have side openings (8) adjacent to the tip of the catheter. The additional side openings (8) are located close to the tip of the catheter, in particular between the tip of the catheter and the balloon.
• the third lumen (6) ends relatively close to the distal end of the elongated body (1 ) where the balloon is disposed and communicates through the bore with the interior of the balloon (9).
• the balloon is adjacent to the tip of the catheter and seals the cervix which is a prerequisite to obtain a sample of the lavage solution.
• the balloon is made of expandable material. When deflated, the balloon (9) lies closely adjacent to the body, so as not to interfere with the insertion or withdrawal of the catheter. When the balloon is inflated by providing e.g. normal saline through the lumen (6) it seals the cervical canal.
• the elongated body does not contain any additional openings between the balloon and the proximal end of the elongated body (1 ).
• Fig. 2 shows frontal view (a) and lateral view (b), top view (c) and sections (A-A, B-B, C-C) (d) of the tip.
• Section B-B exhibits the two openings (4' and 5') of lumens (4 and 5) on the top of the tip (7).
• Section A-A exhibits the three lumens (4, 5 and 6) within in the elongated body (1 ).
• Fig. 3 shows a connecting element (1 1 ) at the proximal end (2) of the elongated body (1 ) in which the lumens (4, 5 and 6) are fixed.
• Fig. 4 shows the proximal end of the catheter, wherein the three lumens are extending the connecting element (1 1 ).
• the lumens (4 and 5) may be connected to syringes.
• the lumen (6) may bear a closing element, such as for example a blocking valve or a plug.
• the connection is normally made by supplying small coupling elements to connect the lumens to the syringes.
• Fig. 5 shows an applicator assembly for connecting two syringes.
• the applicator assembly consists of at least one guide bar (12) and two ports (13). In the ports (13) the flanges 16 and 17 of the syringes are affixed.
• Fig. 6 shows two syringes (14) and (15) affixed in the applicator assembly.
• One syringe (14) is empty, thus the plunger is in the zero position.
• the other syringe (15) is filled with a lavage fluid, for example with normal saline.
• Fig. 7 shows the applicator assembly with an adapter 18 for connecting the flanges 16 and 17 of the syringes (14) and (15).
• Fig. 8 shows the applicator assembly with the adapter 18, wherein the adapter has a lip (19) which allows for the application of the lavage fluid.
• the plunger of syringe (15) is moved to the zero position and the plunger of syringe (14) is pulled back.
• the plunger of the lavage fluid containing syringe By pushing on the plunger of the lavage fluid containing syringe, the fluid is slowly syringed into the uterine cavity and tubes. Simultaneously the plunger of the empty syringe is gently pulled out, sucking the fluid from the uterine cavity and tubes. While one tube slowly empties, the other slowly fills up.
• the adapter 18 with the lip (19) allows for simultaneous rinsing and sucking.
• two 10 ml syringes - one of them containing 10 ml of normal saline - are connected to the two lumens (4 and 5).
• the fluid is slowly syringed into the uterine cavity and tubes.
• the plunger of the empty syringe (14) is gently pulled out, sucking the fluid from the uterine cavity and tubes. While one tube slowly empties, the other slowly fills up.
• a cap is put on the filled syringe and the syringe is sent into the laboratory for diagnosis.
• the catheters used in this procedure typically have means for sealing off the uterus before or during injection of the fluid to prevent backflow into the vagina.
• One such means includes an inflatable intrauterine balloon made from an elastomeric material which is disposed adjacent the distal tip of the catheter.
• the balloon catheter is operated by inserting the distal tip thereof through the cervical canal and into the uterus with the intrauterine balloon deflated.
• the insertion of the distal tip operates to position the deflated intrauterine balloon in the uterus or cervical canal.
• the inflation syringe is used to inflate the balloon with air or saline to create a seal in the cervical canal and the injection syringe is used to inject the desired diagnostic fluid into the uterus.
• the uterus and the fallopian tubes are rinsed with the diagnostic fluid. Due to the specific design of the catheter, a sample of said diagnostic fluid could be obtained at the same time which is useful for further analysis.
• the present invention is a valuable contribution to a convenient, safe and cost-effective test possibly used for early diagnosis or in a screening program looking for cancer or precancerous lesions in women who have no symptoms of the disease.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Heart & Thoracic Surgery (AREA)
• Veterinary Medicine (AREA)
• Biomedical Technology (AREA)
• Engineering & Computer Science (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Hematology (AREA)
• Anesthesiology (AREA)
• Vascular Medicine (AREA)
• Surgery (AREA)
• Pulmonology (AREA)
• Biophysics (AREA)
• Molecular Biology (AREA)
• Pathology (AREA)
• Medical Informatics (AREA)
• Reproductive Health (AREA)
• Gynecology & Obstetrics (AREA)
• Child & Adolescent Psychology (AREA)
• Media Introduction/Drainage Providing Device (AREA)
• Surgical Instruments (AREA)
• Investigating Or Analysing Biological Materials (AREA)
• Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
• Endoscopes (AREA)
• Absorbent Articles And Supports Therefor (AREA)

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• 2014
  • 2014-05-30 NO NO14727217A patent/NO3003449T3/no unknown
  • 2014-05-30 CA CA2912147A patent/CA2912147C/en active Active
  • 2014-05-30 DK DK14727217.3T patent/DK3003449T3/en active
  • 2014-05-30 WO PCT/EP2014/061246 patent/WO2014191549A1/en not_active Ceased
  • 2014-05-30 EP EP14727217.3A patent/EP3003449B1/en not_active Not-in-force
  • 2014-05-30 SI SI201430748T patent/SI3003449T1/en unknown
  • 2014-05-30 HU HUE14727217A patent/HUE038720T2/hu unknown
  • 2014-05-30 PT PT147272173T patent/PT3003449T/pt unknown
  • 2014-05-30 HR HRP20180842TT patent/HRP20180842T1/hr unknown
  • 2014-05-30 ES ES14727217.3T patent/ES2671993T3/es active Active
  • 2014-05-30 PL PL14727217T patent/PL3003449T3/pl unknown
  • 2014-05-30 TR TR2018/07862T patent/TR201807862T4/tr unknown
  • 2014-05-30 US US14/647,073 patent/US10004484B2/en active Active

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