US20140309561A1 - Methods and apparatus for determining fallopian tube occlusion - Google Patents
Methods and apparatus for determining fallopian tube occlusion Download PDFInfo
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- US20140309561A1 US20140309561A1 US14/316,466 US201414316466A US2014309561A1 US 20140309561 A1 US20140309561 A1 US 20140309561A1 US 201414316466 A US201414316466 A US 201414316466A US 2014309561 A1 US2014309561 A1 US 2014309561A1
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- cornua
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/43—Detecting, measuring or recording for evaluating the reproductive systems
- A61B5/4306—Detecting, measuring or recording for evaluating the reproductive systems for evaluating the female reproductive systems, e.g. gynaecological evaluations
- A61B5/4318—Evaluation of the lower reproductive system
- A61B5/4325—Evaluation of the lower reproductive system of the uterine cavities, e.g. uterus, fallopian tubes, ovaries
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
- A61B5/036—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs by means introduced into body tracts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12136—Balloons
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
- A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
- A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
- A61B5/6852—Catheters
- A61B5/6853—Catheters with a balloon
-
- 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
- A61M13/00—Insufflators for therapeutic or disinfectant purposes, i.e. devices for blowing a gas, powder or vapour into the body
- A61M13/003—Blowing gases other than for carrying powders, e.g. for inflating, dilating or rinsing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/42—Gynaecological or obstetrical instruments or methods
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1072—Balloon catheters with special features or adapted for special applications having balloons with two or more compartments
-
- 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
- A61M2025/1088—Balloon catheters with special features or adapted for special applications having special surface characteristics depending on material properties or added substances, e.g. for reducing friction
-
- 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
-
- 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
Definitions
- Tubes can be tied or “ligated,” blocked with mechanical devices such as clips or rings, or scarred closed with electric current.
- partial salpingectomy the fallopian tubes are cut and tied with suture material.
- the Pomeroy technique a widely used version of partial salpingectomy, involves tying a small loop of the tube and cutting off the top segment of the loop.
- Clips are used to block the fallopian tubes by clamping down and cutting off the blood supply to a portion of the tubes, causing a small amount of scarring or fibrosis that prevents fertilization from occurring.
- the two most common clips are the Filshie clip, made of titanium, and the Wolf clip (also known as the Hulka clip), made of plastic. Clips are simple to use, but each type requires a special applicator.
- Occlusion device applied transcervically such as the ESSURE® device manufactured by CONCEPTUS, INC. are also used to permanently block the fallopian tubes.
- Hysterosalpingography is a known method for determining whether a fallopian tube has been successfully occluded.
- the uterus is pressurized with a fluoroscopically visual fluid.
- a radiologist fluoroscopically monitors the fallopian tubes to see if the fluid escapes past the occluded portion. Fluid seen escaping and filling the fallopian tubes, for example near the ovaries would indicate that the fallopian tubes are not occluded and that the patient may still be fertile.
- HSG is problematic in that it requires a radiologist to be present and also requires the use of specialized equipment. Thus HSG also cannot be performed in a doctor's office.
- the invention includes in one embodiment a method to detect fallopian tube occlusion, including visually identifying the cornua of a fallopian tube through a transcervical approach, wherein the fallopian tube was subjected to a procedure to attempt to occlude the fallopian tube, coupling a device to a cornua to fluidly separate the cornua from the remainder of the uterus, pressurizing the cornua, and monitoring the pressurization of the cornua to determine if the fallopian tube is occluded.
- the device may be coupled to the cornua by an inflatable member of the device.
- the inflatable member may be coupled to the cornua by applying force against the cornua.
- the inflatable member may be coupled to the cornua by a applying a vacuum between the inflatable member and the cornua.
- the cornua may be inflated to a pressure greater than 500 mmHg.
- the method may be used with no fluoroscopic visualization of the procedure.
- the inflatable member is configured to separate the first cornua and a second cornua from the remainder of the uterus by occupying a uterine cavity.
- the inflatable member has at least one first lumen that is configured to pressurize the first cornua, the at least one first lumen extending through the inflatable member to align with the first fallopian tube.
- the inflatable member has at least one second lumen that is configured to pressurize the second cornua.
- the at least one second lumen extends through the inflatable member to align with a second fallopian tube and is capable of being activated simultaneously with the at least one first lumen.
- the invention includes in one embodiment a method to determine fallopian tube occlusion, comprising distending a uterus with a first fluid, the uterus including at least one fallopian tube and cornua of the fallopian tube, wherein the fallopian tube was subjected to a procedure to attempt to occlude the fallopian tube, visually identifying the cornua of a fallopian tube through a transcervical approach, coupling a device to the cornua to fluidly separate a sealed portion of the cornua from the remainder of the uterus, applying a vacuum to the sealed portion of the cornua to evacuate a first fluid in the sealed portion of the cornua, pressurizing the cornua with a second fluid, and monitoring the volume of the cornua to determine if the fallopian tube is occluded.
- the device may be coupled to the cornua by an inflatable member of the device.
- the inflatable member may be coupled to the cornua by applying force against the cornua.
- the inflatable member may be coupled to the cornua by a applying a vacuum between the inflatable member and the cornua.
- the cornua may be inflated to a pressure greater than 500 mmHg.
- the second fluid may be visually differentiated from the first fluid.
- the method may additionally include visually confirming that the second fluid does not leak into the first fluid past the device.
- the first fluid removed from the cornua portion may be measured.
- the fallopian tube may be determined to be permanently occluded by the implanted occlusion device by determining if there is more of the second fluid inserted in the evacuated portion of the cornua than of the first fluid removed from the evacuated portion of the cornua.
- the second fluid may be non-soluble with the first fluid.
- the method may be used with no fluoroscopic visualization of the procedure.
- FIG. 1 is a cross section of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device.
- FIGS. 2A-2C show cross sections of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device and a method to determine if the fallopian tube is fully occluded.
- FIGS. 3A and 3B show cross sections of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device and a method to determine if the fallopian tube is fully occluded.
- FIGS. 4A-4C show cross sections of devices which may be used to determine if a fallopian tube is fully occluded.
- FIGS. 5A-5D show cross sections of a uterus including a utero-tubal junction and cornua, and a method to determine if the fallopian tube is fully occluded, according to another embodiment.
- FIGS. 6A and 6B show cross sections of a uterus including a utero-tubal junction and cornua, and a method to determine if the fallopian tube is fully occluded, according to another embodiment.
- FIG. 7 shows a pump for providing pressure, according to one embodiment.
- FIGS. 8A and 8B show cross sections of various embodiments of devices which may be used to determine if a fallopian tube is fully occluded.
- FIGS. 9A-9D show catheter cross sections of various embodiments used to determine if a fallopian tube is fully occluded.
- the implant 106 includes a proximal portion that extends into the ostium or cornua 102 .
- the proximal portion of the implant 106 serves as a visual indicator of the placement of the implant 106 .
- Devices such as the ESSURE® device manufactured by CONCEPTUS, INC. include tail like visual indicators. Not all fallopian tube implants include such indicators. Even with a visual indicator, which shows only positive placement, the device may not fully occlude the utero-tubal junction 104 .
- FIG. 2A illustrates one embodiment of the invention for determining whether a fallopian tube is occluded.
- the fallopian tube shows a previously placed occlusion device 106 .
- a device 200 is shown coupled to the ostium or cornua 102 of a uterus.
- the device 200 may be delivered to the ostium or cornua 102 by a hysteroscope which is transcervically approached through the vagina of the patient.
- the uterus is also typically distended with a working fluid, such as saline.
- the cornua 102 is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor.
- the device 200 includes an a sealing member 210 to fluidly seal and separate a portion of the ostium or cornua 102 from the remainder of the uterus to create a sealed region.
- the sealing member 210 is preferably inflatable, although this is not a requirement of this embodiment of the invention. Force is applied by the operator of the device 200 to seal the sealing member 210 against the ostium or cornua 102 .
- the sealing member 210 has an inflated diameter of the cornua 102 so that a sealed region is created regardless of the expansion and contractions of the cornua 102 .
- the sealing member 210 includes a biocompatible adhesive 212 capable of creating a seal between the sealing member 210 and the endometrium of the uterus.
- the biocompatible adhesive 212 is located along an outer circumference of the sealing member 210 between the sealing member 210 and endometrial layer. It is understood that the adhesive 212 may be strategically applied in specific locations around the sealing member 210 circumference to ensure the sealing member 210 engages with the endometrium. It is also understood that the biocompatible adhesive 212 can be any known adhesive such as wet adhesives, synthetic, natural, bio-adhesives, hydrogels, resins or any other adhesive suitable for application in the uterus.
- the adhesive 212 is a temporary adhesive application and may remove a portion of the endometrium upon removal of the sealing member 210 . However, the adhesive 212 should not cause the removal of any portion of the myometrium upon removal of the sealing member 210 .
- FIG. 2B shows the device 200 applying a positive pressure through lumen 210 , as shown by the “+” marks, within a sealed portion of the cornua 102 .
- a pressure monitor such as a pressure gauge, is also coupled to the lumen 210 . Pressure is applied for a set amount of time, for example 30 seconds to 3 minutes, to determine if the sealed portion will hold pressure. If the sealed portion is able to maintain a desired amount of pressure for a predetermined amount of time, one may be able to positively determine whether the fallopian tube is fully occluded. A pressure drop will show that the fallopian tube is not fully occluded.
- the amount of pressure applied must be large enough to determine whether the fallopian tube is positively occluded.
- the fallopian tube may also be naturally and temporarily blocked. Past tests have determined that as much as 500 mmHg is required to remove a temporary blockage from a fallopian tube.
- a minimum pressure is about 50 mmHg while a maximum pressure is about 350 mmHg.
- an ideal range of pressure is about 90-120 mmHg. Care should be taken such that enough pressure is applied to the cornua 102 to determine whether the fallopian tube is positively occluded while preserving the temporarily blocked fallopian tube. Pressures greater than 500 mmHg may be applied in order to determine intentional fallopian tube occlusion, for example 700-2000 mmHg.
- This method is advantageous over previous method of determining whether a fallopian tube is occluded by previously implanted occlusion devices.
- Previous methods required pressurization of the entire uterus with a fluoroscopically visible fluid, known as Hysterosalpingography (HSG).
- HSG Hysterosalpingography
- a radiologist monitored the fallopian tubes via an x-ray device to determine if the fluoroscopically visible fluid leaks past the previously implanted occlusion devices.
- This prior art procedure is costly, because it requires the presence of a radiologist and specialized x-ray equipment.
- the current invention does not require fluoroscopic visualization of the procedure, and may be performed with a less specialized environment, such as a doctor's office.
- the sealing member 210 may also include an adhesive as previously described above.
- FIG. 2C shows an alternative embodiment of a method for determining whether a fallopian tube is occluded.
- the fallopian tube shows a previously placed occlusion device 106 .
- a device 220 is shown coupled to the ostium or cornua 102 of a uterus.
- the device 220 may be delivered to the ostium or cornua 102 by a hysteroscope which is transcervically approached through the vagina of the patient.
- the uterus is also typically distended with a working fluid, such as saline.
- the cornua is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor.
- FIG. 2C shows the device 200 applying a positive pressure through lumen 260 , as shown by the “+” marks, with in sealed portion of the cornua.
- a pressure monitor (not shown) as commonly known to ones skilled in the art, such as a pressure gauge, is also coupled to the lumen 260 . Pressure is applied for a set amount of time, for example 30 seconds to 3 minutes, to determine if the sealed portion will hold pressure. If the sealed portion is able to maintain a desired amount of pressure for a predetermined amount of time, one may be able to positively determine whether the fallopian tube is fully occluded. A pressure drop will show that the fallopian tube is not fully occluded.
- a bio-adhesive 262 may located on circumferential portions of the prominent sections of the sealing member 230 to ensure a sealed engagement between the sealing member 230 and the endometrium.
- FIG. 3A illustrates one embodiment of the invention for determining whether a fallopian tube is occluded.
- the fallopian tube shows a previously placed occlusion device 106 .
- a device 300 is shown coupled to the cornua 102 of a uterus.
- the device 300 may be delivered to the cornua by a hysteroscope which is transcervically approached through the vagina of the patient.
- the uterus is also typically distended with a working fluid, such as saline.
- the cornua is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor.
- the device 300 includes a sealing member 310 to fluidly seal and separate a portion of the cornua from the remainder of the uterus.
- the sealing member 310 is preferably inflatable, although this is not a requirement of this embodiment invention. Force is applied by the operator of the device 300 to seal the sealing member 310 against the cornua 102 . Alternatively the device 300 may use a vacuum to seal the sealing member 310 against the cornua such as shown in FIG. 2C .
- FIG. 3A shows the device 200 applying a negative pressure through a first lumen 320 , as shown by the “ ⁇ ” marks, within the sealed portion of the cornua. Distension fluid is then evacuated from the sealed portion and measured using a measuring device as known to one commonly skilled in the art, such as a marked syringe.
- the amount of fluid evacuated will typically be small, for example 1 cc or less, given that the volume of the sealed cornua is small.
- FIG. 3B shows a second lumen 330 supplying a second fluid to replace the distension fluid.
- the second fluid is pressurized in a device as described in FIGS. 2A-2C , however it is not necessary to monitor the pressure.
- the pressure may be mechanically set by a pressure source as known to one commonly skilled in the art, such as a syringe or pump coupled to a lockable leur, which is in turn coupled to lumen 330 .
- the volume of the second fluid applied is measured to determine if it is greater than the amount of distension fluid removed. If the volumes are equal or close, for example within 10%, then the fallopian tube is determined to be positively occluded by the occlusion device I.
- the volume of the second fluid is significantly greater than the amount removed, for example more than 20%, then the second fluid likely leaked past the utero-tubal junction and occlusion device 106 . Thus it follows that the occlusion device is not fully occluding the utero-tubal junction.
- the volume of the lumen 330 should be considered when calculating the volume of the second fluid applied into the evacuated portion of the cornua.
- the second fluid may be visually differentiated from the distension fluid, for example colored with a green dye. This aids in visually determining if any leaks exist between the sealing member 310 and cornua.
- the second fluid may also be non-soluble along with the distension fluid, for example bio-compatible vegetable or mineral oil. In that case, both the distension fluid and second fluid may be measured using the same container, e.g. a single syringe, without intermixing between the fluids.
- This method is advantageous over previous method of determining whether a fallopian tube is occluded by previously implanted occlusion devices.
- Previous methods required pressurization of the entire uterus with a fluoroscopically visible fluid, known as Hysterosalpingography (HSG).
- HSG Hysterosalpingography
- This embodiment does not require fluoroscopic visualization of the procedure, and may be performed with a less specialized environment, such as a doctor's office.
- FIG. 4A shows one embodiment of a catheter 400 for use in methods described herein.
- the catheter includes an inflatable member 410 , and a lumen 420 for pressurizing a cornua of a fallopian tube.
- the inflatable member 410 may be characterized as a circular shaped balloon.
- Balloon catheters, materials, and methods of construction are well known in the art, for example as shown in U.S. patents: U.S. Pat. No. 5,522,961, U.S. Pat. No. 6,585,687, and U.S. Pat. No. 6,024,722, all of which are respectively incorporated herein by reference in their respective entirety.
- Appropriate coupling devices such as elles (not shown) are coupled to the proximal portion of the catheter 400 for adding suitable pressures or vacuums to inflatable member 440 and the remaining lumens.
- the catheter is of a suitable working length for use in a transcervical environment, for example 400 mm.
- a back portion 482 of the inflatable member 410 is a concave shape. In another embodiment, the back portion 484 of the inflatable member 410 is a convex shape. A specific concave or convex shape can be selected depending on the curvature of the cornua.
- FIG. 4B shows one embodiment of a catheter 430 for use in methods described herein.
- the catheter includes an inflatable member 440 , and a lumen 450 for pressurizing a cornua of a fallopian tube. It is understood that the lumen 450 can also include a first and second lumen, as shown in FIG. 4C .
- the inflatable member 440 may be characterized as a circular shaped balloon with at least two prominent sections 440 a and 440 b . A vacuum space exists between sections 440 a and 440 b for application of a vacuum by lumens 460 for sealing the inflatable member to a cornua of a fallopian tube.
- Appropriate coupling devices such as elles (not shown) are coupled to the proximal portion of the catheter 430 for adding suitable pressures or vacuums to inflatable member 440 and the remaining lumens.
- the catheter is of a suitable working length for use in a transcervical environment, for example 400 mm.
- FIG. 4C shows one embodiment of a catheter 470 , and a first 476 and second 478 lumen, similar to the embodiment shown in FIG. 3A .
- the inflatable member 472 is characterized by a circular shape and two prominent radial portions 472 a , 472 b extending in a perpendicular direction transverse to the longitudinal axis of the first 476 and second lumen 478 .
- the first 472 a and second 472 b prominent portions form a circular vacuum space 474 which will engage the cornual wall, as already described.
- a vacuum suction is created within the vacuum space 474 through the vacuum lumen 480 .
- the same fluid distension technique can be applied to the catheter 470 through the first 476 and second 478 lumen, as already described in FIGS. 3A and 3B .
- FIG. 5A shows an arrangement 500 having an outer catheter or sheath 502 with a proximal end and a distal end being inserted into a uterus 510 with previously occluded portions 514 .
- the sheath 502 is made from a material such as stainless steel, Teflon, silicone, or other known materials and may be flexible or rigid. In one embodiment, the sheath 502 can have a length in a range of about 12 cm to about 25 cm and a diameter in a range of 0.4 cm to about 0.8 cm.
- the sheath 502 contains two inner catheters 504 .
- the two inner catheters 504 are shown in a collapsed position within the outer sheath 502 with respective balloon end portions 506 located near the distal end of the sheath 502 . As shown, the balloon end portions 506 are not inflated when located within the outer catheter or sheath 502 .
- an outer sheath balloon 508 is connected with the outer sheath 502 .
- the outer sheath balloon 508 remains in a deflated configuration upon insertion of the outer sheath 502 into the cervix.
- FIG. 5B shows the outer sheath 502 being inserted into the uterus so that a distal portion of the outer sheath 502 is located near the fundus region 512 of the uterus 510 .
- the inner catheters 504 are exposed by either advancing the inner catheters 504 or by retracting the outer sheath 502 .
- the balloon end portions 506 are in a deflated configuration when the inner catheters 504 are in a collapsed position.
- FIG. 5B illustrates the outer sheath balloon 508 being inflated to engage the walls of the cervical canal to create a sealed upper region of the uterus 510 .
- the engagement of the outer sheath balloon 508 prevents unwanted movement during subsequent procedures.
- the outer sheath balloon 508 is connected with a first air or fluid source 516 for inflating the outer sheath balloon 508 .
- the sheath 502 is also connected with a second air or fluid source 520 and a vacuum source 526 as will be discussed in further detail.
- FIG. 5C shows the inner catheters 504 being moved from a collapsed position to an open and extended Y-shaped position.
- the first catheter 504 a is movable to seal a first cornua 518 a and the second catheter 504 b is movable to seal a second cornua 518 b .
- the inner catheters 504 can be configured to create pressure within a respective cornua region 518 according to any of the embodiments previously described.
- the inner catheters 504 can be configured to apply a fluid distension technique according to any of the embodiments already described.
- FIG. 5C further shows a first balloon end portion 506 a being inflated by the first air or fluid source 516 .
- the air or fluid source can be a single source that can selectively allow air or fluid to flow to the outer sheath balloon 508 or the end balloon portions 506 through the use of a valve (not shown). It is understood that, in one embodiment, the outer sheath balloon 508 may not be necessary and may be removed or inactivated.
- separate air or fluid sources may be used.
- a separate air or fluid source 520 is provided to apply pressure or fluid distension to the cornua regions 518 a , 518 b through lumens within the inner catheters 504 as already described.
- the air source 520 is a hand pump with a gauge of pressure.
- the fluid source 520 is a syringe.
- a spring mechanism 522 is biased to expand the inner catheters 504 to an open Y-position.
- a wire 524 is connected with the spring mechanism 522 to activate or retract the spring mechanism 522 so that the inner catheters 504 can move from an open Y-position to a closed collapsed position.
- the user may pull on the wire 524 to cause the spring mechanism 522 to retract causing the inner catheters 504 to collapse. It is understood that a spring mechanism that expands upon pulling of the wire 524 may be provided.
- FIG. 5D further shows an embodiment 528 similar to FIG. 5C .
- the end balloon portions 506 have a vacuum cavity as described in FIGS. 2C , 4 B, and 4 C.
- the vacuum cavity engages the cornual walls and creates a sealed region for determining whether a fallopian tube is patent as previously described.
- a vacuum is created within the vacuum cavity through a vacuum source 526 and lumens within the catheter as previously described.
- the vacuum source 526 can also be utilized to deflate the outer sheath balloon 508 and end balloon portions 506 to a collapsed position for withdrawal from the uterus.
- a collapsed withdrawal position would be similar to the insertion configuration shown in FIG. 5A .
- FIG. 6A shows another embodiment 600 where a catheter or sheath 602 having similar dimensions as already described is inserted into the uterus 604 having occluded regions 614 .
- the sheath 602 has a proximal end and a distal end.
- FIG. 6A further shows the proximal end of the catheter including a uterine balloon 606 in a collapsed position.
- An outer sheath balloon 608 is shown in a collapsed position located at a mid-portion of the sheath 602 .
- the uterus balloon 606 is inserted through the cervix and into the uterus toward the fundus region.
- the uterine balloon 606 is connected with an air or fluid source 610 through a lumen of the catheter 602 .
- the uterine balloon 606 is also connected with a vacuum source 612 through a catheter lumen. It is understood that the outer sheath balloon 608 may be connected with the same air or fluid source 610 and vacuum source 612 for selective inflation and collapse. In one embodiment, the outer sheath balloon 608 may be inflated or collapsed independently from the uterine balloon 606 .
- FIG. 6B shows the same embodiment described in FIG. 6A when the uterine balloon 606 and outer sheath balloon 608 are expanded. It is understood that the outer sheath balloon 608 may be removed or inactive, according to one embodiment. However, as shown in FIG. 6B , the outer sheath balloon 608 is expanded to engage the cervical canal wall while the uterine balloon 606 fills the uterine cavity and engages with the cornual regions of the uterus 604 . In one embodiment, the balloon 606 may not conform or fill the entire uterine cavity but it is configured to provide a full engagement with the cornual regions of the uterus without filling the entire uterine cavity.
- the uterine balloon 606 also includes a first tube 616 and a second tube 618 within the inflated balloon 606 .
- the first tube 616 extends from a distal end of the catheter 602 to an upper corner region of the uterine balloon 606 to align with the tubal ostia.
- the first tube 616 includes a distal opening into the first sealed region 620 a of the uterus 604 .
- the second tube 618 includes a distal opening into the second sealed region 620 b of the uterus 604 to align with the tubal ostia.
- first 616 and second tubes 618 may remain flush with an outer surface of the uterine balloon 606 or may extend beyond the outer surface of the uterine balloon 606 protruding into the sealed regions 620 a , 620 b .
- the first 616 and second tube 618 are coupled to lumens within the catheter 602 , as will be described in further detail.
- a second air or fluid pressure source 622 creates a pressure within the first tube 616 , second tube 618 , and sealed regions 620 a , 620 b .
- a hand pump provides the necessary pressure.
- bio-adhesives may be strategically applied on the outer surface of the uterine balloon 606 to ensure the balloon 606 is engaged with the endometrium to create a sealed region.
- FIG. 7 shows an exemplary hand pump 700 for providing a pressure to the sealed regions 620 a , 620 b .
- the hand pump 700 includes a pump handle 702 , a dial 704 , a connecting piece 706 , and a relief valve 708 .
- the pump handle 702 is made of an elastic material such as rubber or silicone that compresses air when a user closes his or her grip. When a user releases his or her grip, the handle 702 returns to an initial uncompressed state.
- the dial 704 indicates to the user how much pressure is created within the sealed regions 620 a , 620 b . In one embodiment, a minimum pressure of 50 mmHg is provided or a maximum of 350 mmHg.
- An ideal pressure range is 90-120 mmHg to determine whether the fallopian tube is successfully occluded.
- a check valve 708 is connected with the hand pump 700 to allow excess pressure to escape when a predetermined value is reached.
- the check valve can be configured to release pressure above 350 mmHg to opening a fallopian tube or dislodging an implant. Therefore, when the user squeezes the pump handle 702 when the dial is reading 350 mmHg, the check valve releases any excess pressure.
- the connecting piece 706 is connected to a catheter 710 .
- the catheter 710 can be of the same configuration and type of any catheter described in this application.
- the dial 704 will indicate a pressure drop so the user will know the regions 620 a , 620 b are not sealed. It is understood that negative or positive pressure can be applied by the hand pump 700 and the pump may be an automatic pump, according to one embodiment.
- FIG. 8A illustrates an exemplary embodiment of a uterine balloon 800 similar to the one shown in FIG. 6B .
- the first 802 and second 804 tubes are shown protruding slightly beyond an outer surface 806 of the uterine balloon 800 .
- the inner wall 808 of the uterine balloon 800 defines an inflation cavity 810 where the air, water, saline, or other liquid fills the balloon 800 for inflation.
- the balloon 800 can be made from an elastic material such as silicone, latex, urethane, and other known flexible polymers.
- the uterine balloon 800 is slightly larger than a typical uterus size.
- the balloon 800 has an inflated width dimension 812 of 1.6-3.0 cm depending on the size of a patient's uterus.
- the inflated width dimension 812 is at least 3.0 cm to ensure the balloon seals and engages with the fundal width.
- the balloon 800 has an inflated length dimension 814 of 5-8 cm.
- the inflated length dimension 814 is at least 8 cm to ensure the balloon seals and engages the uterus length.
- the balloon can have an inflated width in a range from about 3-4 cm, a height in a range of about 5-7 cm, and a depth range of about 1-1.5 cm. A pressure of about 150-250 mmHg can be used to inflate the balloon.
- first 802 and second 804 tubes can be individually connected with a pressure source 816 such as the hand pump and gauge described in FIG. 7 .
- a pressure source 816 such as the hand pump and gauge described in FIG. 7 .
- the advantage of having an individual tube and gauge connection is that each fallopian tube can be verified independently of the other fallopian tube.
- a different pressure is provided in the first tube 802 and second tube 804 so that the individual verification of each tube can be easily achieved.
- more than one hand pump or gauge 816 can be connected with the balloon 800 .
- the first 802 and second 804 tubes can be made from a material including nylon, Teflon, silicone, tygon, polyethylene, and any other known flexible polymer.
- the tubal openings can be in the range of about 0.1-0.3 cm.
- FIG. 8B illustrates another embodiment of a uterine balloon 818 having the same shape and dimensions as described above.
- the uterine balloon 818 includes a first pair of tubes 820 and a second pair of tubes 822 extending from a distal end of the catheter 824 to a respective sealed region in alignment with a tubal ostia.
- the first 820 and second pair of tubes 822 together form a Y-shape as previously described.
- the first pair of tubes 820 include a first lumen 820 a and a second lumen 820 b .
- a negative pressure is applied through the first lumen 820 a within the sealed portion of the cornua.
- Distension fluid is evacuated from the sealed portion and measured using a measuring device 826 such as a marked syringe. It is understood that a separate syringe may be provided for each individual lumen or the same single syringe may be movable between each lumen. Again, a small amount of fluid can be evacuated such as 1 cc or less.
- the second lumen 820 b can supply a second fluid to replace the distension fluid.
- the volume of the second fluid applied is measured to determine if it is greater than the amount of distension fluid removed. As previously mentioned, if the volumes are equal or close (within 10%), the fallopian tube is determined to be positively occluded by the occlusion device.
- the second fluid is assumed to have leaked past the utero-tubal junction and occlusion device as previously described.
- FIGS. 9A-9D illustrate various catheter cross-sectional views that may be implemented in any of the embodiments previously discussed.
- FIG. 9A illustrates a catheter cross-section embodiment having a first lumen 902 , a second lumen 904 and a third lumen 906 within the outer sheath.
- the first lumen 902 is used to deliver air, fluid, saline, or any gas or liquid to inflate an outer sheath balloon 508 , 608 or end balloon 506 , 606 .
- the first lumen 902 may be used to evacuate or vacuum the air or fluid.
- the second 904 and third 906 lumen can be connected to inner catheters 504 , 616 or the inner catheters can be located within the second and third lumen.
- FIG. 9C shows yet another cross-sectional embodiment 920 having a first lumen 922 , a second lumen 924 , a third lumen 926 , a fourth lumen 928 , a fifth lumen 930 , a sixth lumen 932 , and a seventh lumen 934 .
- the first lumen 922 acts primarily as a vacuum source while the second lumen 924 operates to fill the outer sheath balloon with air or fluid.
- the third lumen 926 primarily operates to fill the end balloon portions or uterine balloon with air or fluid.
- the fourth lumen 928 and fifth lumen 930 operate to vacuum or evacuate a distension fluid.
- the sixth 932 and seventh lumen 934 operate to inject a second fluid into the sealed region as previously described.
- FIG. 9D shows another embodiment 936 having a first lumen 938 , a second lumen 940 , a third lumen 942 , a fourth lumen 944 , and a fifth lumen 946 .
- the first 938 , second 940 , and third lumen 942 operate in the same manner as the embodiment described in FIG. 9C .
- the fourth 944 and fifth 946 lumen are provided to supply a monitoring pressure to the sealed region to determine if a respective fallopian tube is patent.
- the fourth lumen 944 correlates to one sealed region and the fifth lumen 946 correlates to a second sealed region of the cornua.
- the lumens show are generally a circular shape, it is understood that the lumen passages can be a variety of cross-sectional shapes including semi-circles, squares, rectangles and any other known shape for delivering air or fluid to a cornua for determining whether a fallopian tube is occluded.
- a significant advantage of the embodiments of the present invention is that the fallopian tubes can be tested for patency either individually or simultaneously. Having both cornual regions tested simultaneously results in reduced testing time and minimizes patient discomfort.
Abstract
Devices and methods for determining fallopian tube occlusion. The methods may include determining fallopian tube occlusions through a pressurization or volumetric determination.
Description
- The present application is a continuation of U.S. patent application Ser. No. 14/042,047, filed on Sep. 30, 2013, entitled “METHODS AND APPARATUS FOR DETERMINING FALLOPIAN TUBE OCCLUSION”, which in turn is a continuation of U.S. patent application Ser. No. 12/577,108, filed on Oct. 9, 2009, entitled, “METHODS AND APPARATUS FOR DETERMINING FALLOPIAN TUBE OCCLUSION”, and issued as U.S. Pat. No. 8,585,616, both of which are incorporated herein by reference.
- 1). Field of the Invention
- The field of the invention relates to methods and apparatuses for determining fallopian tube occlusion.
- 2). Discussion of Related Art
- Female sterilization prevents pregnancy by occluding or mechanically blocking the fallopian tubes. There are several different occlusion techniques—tubes can be tied or “ligated,” blocked with mechanical devices such as clips or rings, or scarred closed with electric current.
- In partial salpingectomy, the fallopian tubes are cut and tied with suture material. The Pomeroy technique, a widely used version of partial salpingectomy, involves tying a small loop of the tube and cutting off the top segment of the loop.
- Clips are used to block the fallopian tubes by clamping down and cutting off the blood supply to a portion of the tubes, causing a small amount of scarring or fibrosis that prevents fertilization from occurring. The two most common clips are the Filshie clip, made of titanium, and the Wolf clip (also known as the Hulka clip), made of plastic. Clips are simple to use, but each type requires a special applicator.
- Tubal rings, like clips, also block the tubes mechanically. A very small loop of the fallopian tube is pulled through the stretched ring. When the ring is released, it stops the blood supply to that small loop. The resulting scarring blocks passage of the sperm or egg. The Yoon Ring, made of silicone, is widely used.
- Electrocoagulation uses electric current to coagulate or burn a small portion of each fallopian tube. Unipolar coagulation passes current through the forceps applied on the tubes, and the current leaves a woman's body through an electrode placed under her thigh. In bipolar coagulation, current enters and leaves a woman through two ends of the forceps.
- Occlusion device applied transcervically such as the ESSURE® device manufactured by CONCEPTUS, INC. are also used to permanently block the fallopian tubes.
- Hysterosalpingography (HSG) is a known method for determining whether a fallopian tube has been successfully occluded. In HSG, the uterus is pressurized with a fluoroscopically visual fluid. A radiologist fluoroscopically monitors the fallopian tubes to see if the fluid escapes past the occluded portion. Fluid seen escaping and filling the fallopian tubes, for example near the ovaries would indicate that the fallopian tubes are not occluded and that the patient may still be fertile. HSG is problematic in that it requires a radiologist to be present and also requires the use of specialized equipment. Thus HSG also cannot be performed in a doctor's office.
- The invention includes in one embodiment a method to detect fallopian tube occlusion, including visually identifying the cornua of a fallopian tube through a transcervical approach, wherein the fallopian tube was subjected to a procedure to attempt to occlude the fallopian tube, coupling a device to a cornua to fluidly separate the cornua from the remainder of the uterus, pressurizing the cornua, and monitoring the pressurization of the cornua to determine if the fallopian tube is occluded.
- The device may be coupled to the cornua by an inflatable member of the device.
- The inflatable member may be coupled to the cornua by applying force against the cornua.
- The inflatable member may be coupled to the cornua by a applying a vacuum between the inflatable member and the cornua.
- The cornua may be inflated to a pressure greater than 500 mmHg.
- The method may be used with no fluoroscopic visualization of the procedure.
- The inflatable member is configured to separate the first cornua and a second cornua from the remainder of the uterus by occupying a uterine cavity.
- The inflatable member has at least one first lumen that is configured to pressurize the first cornua, the at least one first lumen extending through the inflatable member to align with the first fallopian tube. The inflatable member has at least one second lumen that is configured to pressurize the second cornua. The at least one second lumen extends through the inflatable member to align with a second fallopian tube and is capable of being activated simultaneously with the at least one first lumen.
- The invention includes in one embodiment a method to determine fallopian tube occlusion, comprising distending a uterus with a first fluid, the uterus including at least one fallopian tube and cornua of the fallopian tube, wherein the fallopian tube was subjected to a procedure to attempt to occlude the fallopian tube, visually identifying the cornua of a fallopian tube through a transcervical approach, coupling a device to the cornua to fluidly separate a sealed portion of the cornua from the remainder of the uterus, applying a vacuum to the sealed portion of the cornua to evacuate a first fluid in the sealed portion of the cornua, pressurizing the cornua with a second fluid, and monitoring the volume of the cornua to determine if the fallopian tube is occluded.
- The device may be coupled to the cornua by an inflatable member of the device.
- The inflatable member may be coupled to the cornua by applying force against the cornua.
- The inflatable member may be coupled to the cornua by a applying a vacuum between the inflatable member and the cornua.
- The cornua may be inflated to a pressure greater than 500 mmHg.
- The second fluid may be visually differentiated from the first fluid.
- The method may additionally include visually confirming that the second fluid does not leak into the first fluid past the device.
- The first fluid removed from the cornua portion may be measured.
- The fallopian tube may be determined to be permanently occluded by the implanted occlusion device by determining if there is more of the second fluid inserted in the evacuated portion of the cornua than of the first fluid removed from the evacuated portion of the cornua.
- The second fluid may be non-soluble with the first fluid.
- The method may be used with no fluoroscopic visualization of the procedure.
- The invention is further described by way of example(s) with reference to the accompanying drawings, wherein:
-
FIG. 1 is a cross section of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device. -
FIGS. 2A-2C show cross sections of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device and a method to determine if the fallopian tube is fully occluded. -
FIGS. 3A and 3B show cross sections of a uterus including a utero-tubal junction and cornua, and a previously implanted fallopian tube occlusion device and a method to determine if the fallopian tube is fully occluded. -
FIGS. 4A-4C show cross sections of devices which may be used to determine if a fallopian tube is fully occluded. -
FIGS. 5A-5D show cross sections of a uterus including a utero-tubal junction and cornua, and a method to determine if the fallopian tube is fully occluded, according to another embodiment. -
FIGS. 6A and 6B show cross sections of a uterus including a utero-tubal junction and cornua, and a method to determine if the fallopian tube is fully occluded, according to another embodiment. -
FIG. 7 shows a pump for providing pressure, according to one embodiment. -
FIGS. 8A and 8B show cross sections of various embodiments of devices which may be used to determine if a fallopian tube is fully occluded. -
FIGS. 9A-9D show catheter cross sections of various embodiments used to determine if a fallopian tube is fully occluded. -
FIG. 1 shows across section 100 of an ostium orcornua 102 of a uterus. The ostium orcornua 102 is considered to be the flower like opening of a fallopian tube and lies between the greater uterus and the utero-tubal junction 104 (hereinafter, “UTJ”). A previously placedimplant 106 is shown placed in the UTJ. The function of the implant is to serve as a platform for encouraging tissue growth occlusion, as shown by the cross-hatched area. When the UTJ has been fully occluded by tissue growth, typically 3 months after implantation, the fallopian tube will no longer be viable for fertilization. The fallopian tube may also be sealed by other known operations, such as partial salpingectomy, electro-cauterization, or clips or rings applied externally to the fallopian tube. The methods and apparatuses described herein apply equally to all forms of tubal ligation. - The
implant 106 includes a proximal portion that extends into the ostium orcornua 102. The proximal portion of theimplant 106 serves as a visual indicator of the placement of theimplant 106. Devices such as the ESSURE® device manufactured by CONCEPTUS, INC. include tail like visual indicators. Not all fallopian tube implants include such indicators. Even with a visual indicator, which shows only positive placement, the device may not fully occlude the utero-tubal junction 104. -
FIG. 2A illustrates one embodiment of the invention for determining whether a fallopian tube is occluded. The fallopian tube shows a previously placedocclusion device 106. Adevice 200 is shown coupled to the ostium orcornua 102 of a uterus. Thedevice 200 may be delivered to the ostium orcornua 102 by a hysteroscope which is transcervically approached through the vagina of the patient. The uterus is also typically distended with a working fluid, such as saline. Thecornua 102 is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor. - As shown, the
device 200 includes an a sealingmember 210 to fluidly seal and separate a portion of the ostium orcornua 102 from the remainder of the uterus to create a sealed region. The sealingmember 210 is preferably inflatable, although this is not a requirement of this embodiment of the invention. Force is applied by the operator of thedevice 200 to seal the sealingmember 210 against the ostium orcornua 102. In one embodiment, the sealingmember 210 has an inflated diameter of thecornua 102 so that a sealed region is created regardless of the expansion and contractions of thecornua 102. - In one embodiment, the sealing
member 210 includes abiocompatible adhesive 212 capable of creating a seal between the sealingmember 210 and the endometrium of the uterus. In one embodiment, thebiocompatible adhesive 212 is located along an outer circumference of the sealingmember 210 between the sealingmember 210 and endometrial layer. It is understood that the adhesive 212 may be strategically applied in specific locations around the sealingmember 210 circumference to ensure the sealingmember 210 engages with the endometrium. It is also understood that thebiocompatible adhesive 212 can be any known adhesive such as wet adhesives, synthetic, natural, bio-adhesives, hydrogels, resins or any other adhesive suitable for application in the uterus. - In one embodiment, the adhesive 212 is a temporary adhesive application and may remove a portion of the endometrium upon removal of the sealing
member 210. However, the adhesive 212 should not cause the removal of any portion of the myometrium upon removal of the sealingmember 210. -
FIG. 2B shows thedevice 200 applying a positive pressure throughlumen 210, as shown by the “+” marks, within a sealed portion of thecornua 102. A pressure monitor, such as a pressure gauge, is also coupled to thelumen 210. Pressure is applied for a set amount of time, for example 30 seconds to 3 minutes, to determine if the sealed portion will hold pressure. If the sealed portion is able to maintain a desired amount of pressure for a predetermined amount of time, one may be able to positively determine whether the fallopian tube is fully occluded. A pressure drop will show that the fallopian tube is not fully occluded. - The amount of pressure applied must be large enough to determine whether the fallopian tube is positively occluded. The fallopian tube may also be naturally and temporarily blocked. Past tests have determined that as much as 500 mmHg is required to remove a temporary blockage from a fallopian tube. In another embodiment, a minimum pressure is about 50 mmHg while a maximum pressure is about 350 mmHg. In one embodiment, an ideal range of pressure is about 90-120 mmHg. Care should be taken such that enough pressure is applied to the
cornua 102 to determine whether the fallopian tube is positively occluded while preserving the temporarily blocked fallopian tube. Pressures greater than 500 mmHg may be applied in order to determine intentional fallopian tube occlusion, for example 700-2000 mmHg. - This method is advantageous over previous method of determining whether a fallopian tube is occluded by previously implanted occlusion devices. Previous methods required pressurization of the entire uterus with a fluoroscopically visible fluid, known as Hysterosalpingography (HSG). A radiologist monitored the fallopian tubes via an x-ray device to determine if the fluoroscopically visible fluid leaks past the previously implanted occlusion devices. This prior art procedure is costly, because it requires the presence of a radiologist and specialized x-ray equipment. The current invention does not require fluoroscopic visualization of the procedure, and may be performed with a less specialized environment, such as a doctor's office. The sealing
member 210 may also include an adhesive as previously described above. -
FIG. 2C shows an alternative embodiment of a method for determining whether a fallopian tube is occluded. The fallopian tube shows a previously placedocclusion device 106. Adevice 220 is shown coupled to the ostium orcornua 102 of a uterus. Thedevice 220 may be delivered to the ostium orcornua 102 by a hysteroscope which is transcervically approached through the vagina of the patient. The uterus is also typically distended with a working fluid, such as saline. The cornua is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor. - As shown, the
device 220 includes an a sealingmember 230 to fluidly seal and separate a portion of the cornua from the remainder of the uterus. The sealingmember 230 is preferably inflatable, although this is not a requirement of this embodiment of the invention. The sealingmember 230features sealing chambers 240 circumferentially surrounding the sealingmember 230. The sealing member may be defined by two prominent sections of the sealingmember 230. A vacuum is applied throughvacuum lumens 250 to positively seal the sealing member to thecornua 102. A vacuum source (not shown) as known to one commonly skilled in the art, such as a pump, is also coupled to thevacuum lumens 250. -
FIG. 2C shows thedevice 200 applying a positive pressure throughlumen 260, as shown by the “+” marks, with in sealed portion of the cornua. A pressure monitor (not shown) as commonly known to ones skilled in the art, such as a pressure gauge, is also coupled to thelumen 260. Pressure is applied for a set amount of time, for example 30 seconds to 3 minutes, to determine if the sealed portion will hold pressure. If the sealed portion is able to maintain a desired amount of pressure for a predetermined amount of time, one may be able to positively determine whether the fallopian tube is fully occluded. A pressure drop will show that the fallopian tube is not fully occluded. - This method is particularly advantageous because it allows an operator remove his hands from
device 220, while simultaneously maintaining a positive seal against the cornua. In one embodiment, a bio-adhesive 262 may located on circumferential portions of the prominent sections of the sealingmember 230 to ensure a sealed engagement between the sealingmember 230 and the endometrium. -
FIG. 3A illustrates one embodiment of the invention for determining whether a fallopian tube is occluded. The fallopian tube shows a previously placedocclusion device 106. Adevice 300 is shown coupled to thecornua 102 of a uterus. Thedevice 300 may be delivered to the cornua by a hysteroscope which is transcervically approached through the vagina of the patient. The uterus is also typically distended with a working fluid, such as saline. The cornua is visually identified using an image provided by hysteroscope, which may also be coupled to a monitor. - As shown, the
device 300 includes a sealingmember 310 to fluidly seal and separate a portion of the cornua from the remainder of the uterus. The sealingmember 310 is preferably inflatable, although this is not a requirement of this embodiment invention. Force is applied by the operator of thedevice 300 to seal the sealingmember 310 against thecornua 102. Alternatively thedevice 300 may use a vacuum to seal the sealingmember 310 against the cornua such as shown inFIG. 2C . -
FIG. 3A shows thedevice 200 applying a negative pressure through afirst lumen 320, as shown by the “−” marks, within the sealed portion of the cornua. Distension fluid is then evacuated from the sealed portion and measured using a measuring device as known to one commonly skilled in the art, such as a marked syringe. The amount of fluid evacuated will typically be small, for example 1 cc or less, given that the volume of the sealed cornua is small. -
FIG. 3B shows asecond lumen 330 supplying a second fluid to replace the distension fluid. The second fluid is pressurized in a device as described inFIGS. 2A-2C , however it is not necessary to monitor the pressure. The pressure may be mechanically set by a pressure source as known to one commonly skilled in the art, such as a syringe or pump coupled to a lockable leur, which is in turn coupled tolumen 330. - The volume of the second fluid applied is measured to determine if it is greater than the amount of distension fluid removed. If the volumes are equal or close, for example within 10%, then the fallopian tube is determined to be positively occluded by the occlusion device I.
- If the volume of the second fluid is significantly greater than the amount removed, for example more than 20%, then the second fluid likely leaked past the utero-tubal junction and
occlusion device 106. Thus it follows that the occlusion device is not fully occluding the utero-tubal junction. The volume of thelumen 330 should be considered when calculating the volume of the second fluid applied into the evacuated portion of the cornua. - The second fluid may be visually differentiated from the distension fluid, for example colored with a green dye. This aids in visually determining if any leaks exist between the sealing
member 310 and cornua. The second fluid may also be non-soluble along with the distension fluid, for example bio-compatible vegetable or mineral oil. In that case, both the distension fluid and second fluid may be measured using the same container, e.g. a single syringe, without intermixing between the fluids. - This method is advantageous over previous method of determining whether a fallopian tube is occluded by previously implanted occlusion devices. Previous methods required pressurization of the entire uterus with a fluoroscopically visible fluid, known as Hysterosalpingography (HSG). This embodiment does not require fluoroscopic visualization of the procedure, and may be performed with a less specialized environment, such as a doctor's office.
-
FIG. 4A shows one embodiment of acatheter 400 for use in methods described herein. The catheter includes aninflatable member 410, and alumen 420 for pressurizing a cornua of a fallopian tube. Theinflatable member 410 may be characterized as a circular shaped balloon. Balloon catheters, materials, and methods of construction are well known in the art, for example as shown in U.S. patents: U.S. Pat. No. 5,522,961, U.S. Pat. No. 6,585,687, and U.S. Pat. No. 6,024,722, all of which are respectively incorporated herein by reference in their respective entirety. Appropriate coupling devices, such as leurs (not shown) are coupled to the proximal portion of thecatheter 400 for adding suitable pressures or vacuums toinflatable member 440 and the remaining lumens. The catheter is of a suitable working length for use in a transcervical environment, for example 400 mm. - In one embodiment, a
back portion 482 of theinflatable member 410 is a concave shape. In another embodiment, theback portion 484 of theinflatable member 410 is a convex shape. A specific concave or convex shape can be selected depending on the curvature of the cornua. -
FIG. 4B shows one embodiment of acatheter 430 for use in methods described herein. The catheter includes aninflatable member 440, and alumen 450 for pressurizing a cornua of a fallopian tube. It is understood that thelumen 450 can also include a first and second lumen, as shown inFIG. 4C . Theinflatable member 440, may be characterized as a circular shaped balloon with at least two prominent sections 440 a and 440 b. A vacuum space exists between sections 440 a and 440 b for application of a vacuum bylumens 460 for sealing the inflatable member to a cornua of a fallopian tube. Appropriate coupling devices, such as leurs (not shown) are coupled to the proximal portion of thecatheter 430 for adding suitable pressures or vacuums toinflatable member 440 and the remaining lumens. The catheter is of a suitable working length for use in a transcervical environment, for example 400 mm. -
FIG. 4C shows one embodiment of acatheter 470, and a first 476 and second 478 lumen, similar to the embodiment shown inFIG. 3A . Again, theinflatable member 472 is characterized by a circular shape and two prominent radial portions 472 a, 472 b extending in a perpendicular direction transverse to the longitudinal axis of the first 476 andsecond lumen 478. The first 472 a and second 472 b prominent portions form acircular vacuum space 474 which will engage the cornual wall, as already described. A vacuum suction is created within thevacuum space 474 through thevacuum lumen 480. The same fluid distension technique can be applied to thecatheter 470 through the first 476 and second 478 lumen, as already described inFIGS. 3A and 3B . -
FIG. 5A shows anarrangement 500 having an outer catheter orsheath 502 with a proximal end and a distal end being inserted into auterus 510 with previouslyoccluded portions 514. Thesheath 502 is made from a material such as stainless steel, Teflon, silicone, or other known materials and may be flexible or rigid. In one embodiment, thesheath 502 can have a length in a range of about 12 cm to about 25 cm and a diameter in a range of 0.4 cm to about 0.8 cm. - The
sheath 502 contains twoinner catheters 504. The twoinner catheters 504 are shown in a collapsed position within theouter sheath 502 with respectiveballoon end portions 506 located near the distal end of thesheath 502. As shown, theballoon end portions 506 are not inflated when located within the outer catheter orsheath 502. - In addition, an
outer sheath balloon 508 is connected with theouter sheath 502. Theouter sheath balloon 508 remains in a deflated configuration upon insertion of theouter sheath 502 into the cervix. -
FIG. 5B shows theouter sheath 502 being inserted into the uterus so that a distal portion of theouter sheath 502 is located near thefundus region 512 of theuterus 510. Theinner catheters 504 are exposed by either advancing theinner catheters 504 or by retracting theouter sheath 502. Theballoon end portions 506 are in a deflated configuration when theinner catheters 504 are in a collapsed position. Upon reaching a desired position,FIG. 5B illustrates theouter sheath balloon 508 being inflated to engage the walls of the cervical canal to create a sealed upper region of theuterus 510. The engagement of theouter sheath balloon 508 prevents unwanted movement during subsequent procedures. Theouter sheath balloon 508 is connected with a first air orfluid source 516 for inflating theouter sheath balloon 508. Thesheath 502 is also connected with a second air orfluid source 520 and avacuum source 526 as will be discussed in further detail. -
FIG. 5C shows theinner catheters 504 being moved from a collapsed position to an open and extended Y-shaped position. The first catheter 504 a is movable to seal a first cornua 518 a and the second catheter 504 b is movable to seal a second cornua 518 b. Theinner catheters 504 can be configured to create pressure within a respective cornua region 518 according to any of the embodiments previously described. Moreover, theinner catheters 504 can be configured to apply a fluid distension technique according to any of the embodiments already described. -
FIG. 5C further shows a first balloon end portion 506 a being inflated by the first air orfluid source 516. In one embodiment, the air or fluid source can be a single source that can selectively allow air or fluid to flow to theouter sheath balloon 508 or theend balloon portions 506 through the use of a valve (not shown). It is understood that, in one embodiment, theouter sheath balloon 508 may not be necessary and may be removed or inactivated. In another embodiment, separate air or fluid sources may be used. In one embodiment, a separate air orfluid source 520 is provided to apply pressure or fluid distension to the cornua regions 518 a, 518 b through lumens within theinner catheters 504 as already described. In one embodiment, theair source 520 is a hand pump with a gauge of pressure. In another embodiment, thefluid source 520 is a syringe. - In one embodiment, a
spring mechanism 522 is biased to expand theinner catheters 504 to an open Y-position. Awire 524 is connected with thespring mechanism 522 to activate or retract thespring mechanism 522 so that theinner catheters 504 can move from an open Y-position to a closed collapsed position. In one embodiment, the user may pull on thewire 524 to cause thespring mechanism 522 to retract causing theinner catheters 504 to collapse. It is understood that a spring mechanism that expands upon pulling of thewire 524 may be provided. -
FIG. 5D further shows anembodiment 528 similar toFIG. 5C . However, theend balloon portions 506 have a vacuum cavity as described inFIGS. 2C , 4B, and 4C. The vacuum cavity engages the cornual walls and creates a sealed region for determining whether a fallopian tube is patent as previously described. A vacuum is created within the vacuum cavity through avacuum source 526 and lumens within the catheter as previously described. Thevacuum source 526 can also be utilized to deflate theouter sheath balloon 508 and endballoon portions 506 to a collapsed position for withdrawal from the uterus. A collapsed withdrawal position would be similar to the insertion configuration shown inFIG. 5A . -
FIG. 6A shows anotherembodiment 600 where a catheter orsheath 602 having similar dimensions as already described is inserted into theuterus 604 havingoccluded regions 614. Thesheath 602 has a proximal end and a distal end.FIG. 6A further shows the proximal end of the catheter including auterine balloon 606 in a collapsed position. Anouter sheath balloon 608 is shown in a collapsed position located at a mid-portion of thesheath 602. In a collapsed position, theuterus balloon 606 is inserted through the cervix and into the uterus toward the fundus region. Theuterine balloon 606 is connected with an air orfluid source 610 through a lumen of thecatheter 602. Theuterine balloon 606 is also connected with avacuum source 612 through a catheter lumen. It is understood that theouter sheath balloon 608 may be connected with the same air orfluid source 610 andvacuum source 612 for selective inflation and collapse. In one embodiment, theouter sheath balloon 608 may be inflated or collapsed independently from theuterine balloon 606. -
FIG. 6B shows the same embodiment described inFIG. 6A when theuterine balloon 606 andouter sheath balloon 608 are expanded. It is understood that theouter sheath balloon 608 may be removed or inactive, according to one embodiment. However, as shown inFIG. 6B , theouter sheath balloon 608 is expanded to engage the cervical canal wall while theuterine balloon 606 fills the uterine cavity and engages with the cornual regions of theuterus 604. In one embodiment, theballoon 606 may not conform or fill the entire uterine cavity but it is configured to provide a full engagement with the cornual regions of the uterus without filling the entire uterine cavity. - The
uterine balloon 606 has a triangular or heart-shaped configuration when inflated. The uterine cavity is expandable so that it may stretch or adjust to the inflateduterine balloon 606 so that two sealed regions 620 a, 620 b are created. The sealed regions 620 a, 620 b created are air tight or fluid tight if theoccluded areas 614 are not patent. Theuterine balloon 606 engages the fundus and the cornua of the uterus to create a sealed region. As mentioned, theuterine balloon 606 is inflatable with air, water, saline solution, or any other known fluid. - The
uterine balloon 606 also includes afirst tube 616 and asecond tube 618 within theinflated balloon 606. Thefirst tube 616 extends from a distal end of thecatheter 602 to an upper corner region of theuterine balloon 606 to align with the tubal ostia. Thefirst tube 616 includes a distal opening into the first sealed region 620 a of theuterus 604. Thesecond tube 618 includes a distal opening into the second sealed region 620 b of theuterus 604 to align with the tubal ostia. It is understood that the first 616 andsecond tubes 618 may remain flush with an outer surface of theuterine balloon 606 or may extend beyond the outer surface of theuterine balloon 606 protruding into the sealed regions 620 a, 620 b. The first 616 andsecond tube 618 are coupled to lumens within thecatheter 602, as will be described in further detail. - After the sealed regions 620 a, 620 b are created, a second air or
fluid pressure source 622 creates a pressure within thefirst tube 616,second tube 618, and sealed regions 620 a, 620 b. In one embodiment, a hand pump provides the necessary pressure. In another embodiment, bio-adhesives (as previously described) may be strategically applied on the outer surface of theuterine balloon 606 to ensure theballoon 606 is engaged with the endometrium to create a sealed region. -
FIG. 7 shows anexemplary hand pump 700 for providing a pressure to the sealed regions 620 a, 620 b. Thehand pump 700 includes apump handle 702, adial 704, a connectingpiece 706, and arelief valve 708. The pump handle 702 is made of an elastic material such as rubber or silicone that compresses air when a user closes his or her grip. When a user releases his or her grip, thehandle 702 returns to an initial uncompressed state. Thedial 704 indicates to the user how much pressure is created within the sealed regions 620 a, 620 b. In one embodiment, a minimum pressure of 50 mmHg is provided or a maximum of 350 mmHg. An ideal pressure range is 90-120 mmHg to determine whether the fallopian tube is successfully occluded. Acheck valve 708 is connected with thehand pump 700 to allow excess pressure to escape when a predetermined value is reached. For example, in one embodiment, the check valve can be configured to release pressure above 350 mmHg to opening a fallopian tube or dislodging an implant. Therefore, when the user squeezes the pump handle 702 when the dial is reading 350 mmHg, the check valve releases any excess pressure. The connectingpiece 706 is connected to acatheter 710. Thecatheter 710 can be of the same configuration and type of any catheter described in this application. Of course, if a fallopian tube is patent, thedial 704 will indicate a pressure drop so the user will know the regions 620 a, 620 b are not sealed. It is understood that negative or positive pressure can be applied by thehand pump 700 and the pump may be an automatic pump, according to one embodiment. -
FIG. 8A illustrates an exemplary embodiment of auterine balloon 800 similar to the one shown inFIG. 6B . The first 802 and second 804 tubes are shown protruding slightly beyond anouter surface 806 of theuterine balloon 800. Theinner wall 808 of theuterine balloon 800 defines aninflation cavity 810 where the air, water, saline, or other liquid fills theballoon 800 for inflation. Theballoon 800 can be made from an elastic material such as silicone, latex, urethane, and other known flexible polymers. In one embodiment, theuterine balloon 800 is slightly larger than a typical uterus size. In one embodiment, theballoon 800 has an inflatedwidth dimension 812 of 1.6-3.0 cm depending on the size of a patient's uterus. In another embodiment, theinflated width dimension 812 is at least 3.0 cm to ensure the balloon seals and engages with the fundal width. In one embodiment, theballoon 800 has an inflatedlength dimension 814 of 5-8 cm. In another embodiment, theinflated length dimension 814 is at least 8 cm to ensure the balloon seals and engages the uterus length. In yet another embodiment, the balloon can have an inflated width in a range from about 3-4 cm, a height in a range of about 5-7 cm, and a depth range of about 1-1.5 cm. A pressure of about 150-250 mmHg can be used to inflate the balloon. - As previously mentioned, the first 802 and second 804 tubes can be individually connected with a
pressure source 816 such as the hand pump and gauge described inFIG. 7 . The advantage of having an individual tube and gauge connection is that each fallopian tube can be verified independently of the other fallopian tube. In one embodiment, a different pressure is provided in thefirst tube 802 andsecond tube 804 so that the individual verification of each tube can be easily achieved. In one embodiment, more than one hand pump or gauge 816 can be connected with theballoon 800. - The first 802 and second 804 tubes can be made from a material including nylon, Teflon, silicone, tygon, polyethylene, and any other known flexible polymer. In one embodiment, the tubal openings can be in the range of about 0.1-0.3 cm.
-
FIG. 8B illustrates another embodiment of auterine balloon 818 having the same shape and dimensions as described above. Theuterine balloon 818 includes a first pair oftubes 820 and a second pair oftubes 822 extending from a distal end of thecatheter 824 to a respective sealed region in alignment with a tubal ostia. The first 820 and second pair oftubes 822 together form a Y-shape as previously described. - The first pair of
tubes 820 include a first lumen 820 a and a second lumen 820 b. As described inFIG. 3A , a negative pressure is applied through the first lumen 820 a within the sealed portion of the cornua. Distension fluid is evacuated from the sealed portion and measured using ameasuring device 826 such as a marked syringe. It is understood that a separate syringe may be provided for each individual lumen or the same single syringe may be movable between each lumen. Again, a small amount of fluid can be evacuated such as 1 cc or less. - The second lumen 820 b can supply a second fluid to replace the distension fluid. The volume of the second fluid applied is measured to determine if it is greater than the amount of distension fluid removed. As previously mentioned, if the volumes are equal or close (within 10%), the fallopian tube is determined to be positively occluded by the occlusion device.
- On the other hand, if the volume of the second fluid is significantly greater than the amount removed, the second fluid is assumed to have leaked past the utero-tubal junction and occlusion device as previously described.
- The second pair of
tubes 822 include a first lumen 822 a for removing distension fluid and a second lumen 822 b for replacing the fluid. The second pair oftubes 822 operate in the exact same manner as described above with respect to the first pair oftubes 820. -
FIGS. 9A-9D illustrate various catheter cross-sectional views that may be implemented in any of the embodiments previously discussed.FIG. 9A illustrates a catheter cross-section embodiment having afirst lumen 902, asecond lumen 904 and athird lumen 906 within the outer sheath. In one embodiment, thefirst lumen 902 is used to deliver air, fluid, saline, or any gas or liquid to inflate anouter sheath balloon end balloon first lumen 902 may be used to evacuate or vacuum the air or fluid. In one embodiment, the second 904 and third 906 lumen can be connected toinner catheters -
FIG. 9B shows anotherembodiment 908 having afirst lumen 910, asecond lumen 912, athird lumen 914, afourth lumen 916, and afifth lumen 918. Again, thefirst lumen 902 provides air or fluid to the balloons and may also evacuate or vacuum the air or fluid. The second 912 and third 914 lumens operate to evacuate a distension fluid from respective catheters, as previously described. The fourth 916 and fifth 918 lumens allow a replacement fluid to be injected into a sealed region, as previously described. -
FIG. 9C shows yet anothercross-sectional embodiment 920 having afirst lumen 922, asecond lumen 924, athird lumen 926, afourth lumen 928, afifth lumen 930, asixth lumen 932, and aseventh lumen 934. Thefirst lumen 922 acts primarily as a vacuum source while thesecond lumen 924 operates to fill the outer sheath balloon with air or fluid. Thethird lumen 926 primarily operates to fill the end balloon portions or uterine balloon with air or fluid. Thefourth lumen 928 andfifth lumen 930 operate to vacuum or evacuate a distension fluid. The sixth 932 andseventh lumen 934 operate to inject a second fluid into the sealed region as previously described. -
FIG. 9D shows anotherembodiment 936 having afirst lumen 938, asecond lumen 940, athird lumen 942, afourth lumen 944, and afifth lumen 946. The first 938, second 940, andthird lumen 942 operate in the same manner as the embodiment described inFIG. 9C . The fourth 944 and fifth 946 lumen are provided to supply a monitoring pressure to the sealed region to determine if a respective fallopian tube is patent. Thefourth lumen 944 correlates to one sealed region and thefifth lumen 946 correlates to a second sealed region of the cornua. - Although the lumens show are generally a circular shape, it is understood that the lumen passages can be a variety of cross-sectional shapes including semi-circles, squares, rectangles and any other known shape for delivering air or fluid to a cornua for determining whether a fallopian tube is occluded.
- A significant advantage of the embodiments of the present invention is that the fallopian tubes can be tested for patency either individually or simultaneously. Having both cornual regions tested simultaneously results in reduced testing time and minimizes patient discomfort.
- While certain exemplary embodiments have been described and shown in the accompanying drawings, it is to be understood that such embodiments are merely illustrative and not restrictive of the current invention, and that this invention is not restricted to the specific constructions and arrangements shown and described since modifications may occur to those ordinarily skilled in the art.
Claims (22)
1. A system for determining fallopian tube occlusion comprising:
means for distending a uterus with a first fluid, the uterus including a first cornua of a first fallopian tube;
means for coupling a device to the first cornua to fluidly separate a first sealed portion of the first cornua from the remainder of the distended uterus;
means for evacuating a first volume of the first fluid from the first sealed portion;
means for measuring the first volume of the first fluid;
means for supplying a second fluid to the first sealed portion;
means for measuring a second volume of the second fluid supplied to the first sealed portion;
means for comparing the first volume of the first fluid to the second volume of the second fluid to determine if the first fallopian tube is occluded.
2. The system of claim 1 , wherein the first fallopian tube is determined to be occluded if the second volume is within 10% of the first volume.
3. The system of claim 1 , wherein means for measuring the first volume comprise a marked syringe.
4. The system of claim 1 , wherein the means for measuring the second volume comprise a marked syringe.
5. The system of claim 1 , wherein measuring the first volume comprises measuring 1 cc or less.
6. The system of claim 1 , wherein the device comprises a first catheter, and coupling the device to the first cornua to fluidly separate the first sealed portion of the first cornua from the remainder of the distended uterus comprises:
expanding a first balloon end portion of the first catheter against the first cornua to engage the first cornua.
7. The system of claim 6 , further comprising:
means for expanding the first balloon end portion with a single air or fluid source.
8. The system of claim 6 , further comprising:
means for applying a vacuum to a first vacuum cavity in the first balloon end portion to further engage the first cornua.
9. The system of claim 1 , wherein the means for coupling the device to the first cornua to fluidly separate the first sealed portion of the first cornua from the remainder of the distended uterus comprise:
means for expanding a uterine balloon and engaging the first cornua with the expanded uterine balloon.
10. The system of claim 1 , wherein the second fluid is not soluble with the first fluid.
11. A catheter for use in a system for determining fallopian tube occlusion, comprising:
an elongated flexible portion having a proximal end and a distal end, the distal end configured for fluidly sealing a cornua of a fallopian tube in a uterus from the remainder of the uterus, the elongated flexible portion comprising:
an inflatable portion at the distal end, the inflatable portion configured to seal the cornua from the uterus when the inflatable portion is inflated;
a first lumen configured to receive a first fluid at the proximal end and deliver a first volume of the first fluid to the sealed cornua at the distal end;
a second lumen configured to evacuate at least a portion of the first volume of the first fluid at the distal end and evacuate the at least a portion of the first volume of the first fluid from the sealed cornua.
12. The catheter of claim 11 , wherein the inflatable portion comprises:
first and second radial portions extending in a substantially perpendicular direction transverse to the longitudinal axis of the elongated flexible portion, wherein the first and second radial portions form a substantially circular vacuum space between the catheter a wall of the cornua and are configured to engage the wall of the cornua.
13. The catheter of claim 12 , wherein the elongated flexible portion further comprises one or more additional lumens fluidly coupled to the substantially circular vacuum space, wherein the one or more additional lumens are configured to provide a vacuum source to the substantially circular vacuum space.
14. The catheter of claim 12 , further comprising:
a biocompatible adhesive on the outer circumference of one or both of the first and second radial portions where the radial portions engage the wall of the cornua.
15. A system for determining fallopian tube occlusion comprising:
an elongated substantially circular outer sheath configured for insertion into a uterus;
an outer sheath balloon surrounding a circumference of the outer sheath, the outer sheath balloon configured to fluidly seal the uterus when inflated;
a first and a second catheter substantially enclosed by the outer sheath, each catheter comprising:
an elongated flexible portion having a proximal end and a distal end, the distal end configured for fluidly sealing a cornua of a fallopian tube in the uterus, the elongated flexible portion including:
an inflatable portion at the distal end, the inflatable portion configured to fluidly seal the cornua from the uterus when the inflatable portion is inflated;
a first lumen configured to receive a first fluid at the proximal end and deliver a first volume of the first fluid to the fluidly sealed cornua at the distal end;
a second lumen configured to evacuate at least a portion of the first volume of the first fluid at the distal end and the second lumen is further configured to deliver the evacuated at least a portion of the first volume of the first fluid to the proximal end of the second lumen.
16. The system of claim 15 , wherein the proximal end of the second lumen is further configured for coupling to a measuring means, and the measuring means comprises a marked syringe.
17. The system of claim 15 , further comprising:
a first fluid source coupled to the proximal end of the first lumen of each of the first and second catheters.
18. The system of claim 15 , wherein each catheter further comprises:
first and second radial portions extending in a substantially perpendicular direction transverse to the longitudinal axis of the elongated flexible portion, wherein the first and second prominent radial portions form a substantially circular vacuum space, configured to engage a wall of a cornua of the uterus.
19. The system of claim 18 , wherein the elongated flexible portion of each catheter further comprises one or more additional lumens fluidly coupled to the substantially circular vacuum space, wherein the one or more additional lumens are configured to provide a vacuum source to the substantially circular vacuum space.
20. The system of claim 19 , further comprising:
a vacuum source coupled to the proximal end of the one or more additional lumens within each catheter.
21. The system of claim 15 , further comprising:
a biocompatible adhesive on the outer circumference of at least one of the first and second radial portions of each catheter, where the radial portions engage the wall of the cornua.
22. The system of claim 15 , wherein the further comprising:
a spring mechanism disposed between the first and catheter, the spring mechanism configured to expand the first and second catheters into a Y-position to facilitate placement of each of the first and second catheters into a respective first and second cornua of the uterus; and
a retractable member coupled to the spring mechanism, wherein the retractable member is configured to activate the first and second catheters into the Y-position, or retract the spring mechanism so that the first and second catheters are in a closed or collapsed position.
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US14/316,466 US20140309561A1 (en) | 2009-10-09 | 2014-06-26 | Methods and apparatus for determining fallopian tube occlusion |
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US14/316,466 US20140309561A1 (en) | 2009-10-09 | 2014-06-26 | Methods and apparatus for determining fallopian tube occlusion |
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Families Citing this family (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6309384B1 (en) | 1999-02-01 | 2001-10-30 | Adiana, Inc. | Method and apparatus for tubal occlusion |
US8123693B2 (en) | 2005-06-20 | 2012-02-28 | Conceptus, Inc. | Methods and devices for determining lumen occlusion |
US20100063360A1 (en) * | 2006-11-28 | 2010-03-11 | Adiana, Inc. | Side-arm Port Introducer |
US8231619B2 (en) * | 2010-01-22 | 2012-07-31 | Cytyc Corporation | Sterilization device and method |
US20120130272A1 (en) * | 2010-11-19 | 2012-05-24 | Hologic, Inc. | Lumen occlusion detection |
KR101558719B1 (en) * | 2011-01-25 | 2015-10-07 | 엔비전 메디컬 코포레이션 | Systems and methods for maintaining a narrow body lumen |
US9655557B2 (en) | 2011-02-04 | 2017-05-23 | Minerva Surgical, Inc. | Methods and systems for evaluating the integrity of a uterine cavity |
US20120316460A1 (en) * | 2011-06-07 | 2012-12-13 | Stout Christopher A | Fluid delivery system with pressure monitoring device |
US20140323859A1 (en) * | 2011-11-13 | 2014-10-30 | Nvision Medical Corporation | Device and process to confirm occlusion of the fallopian tube |
US20150272622A1 (en) | 2011-12-22 | 2015-10-01 | Previvo Genetics, Llc | Recovery and processing of human embryos formed in vivo |
US9216037B2 (en) | 2013-06-21 | 2015-12-22 | Previvo Genetics, Llc | Uterine lavage for embryo retrieval |
US9282995B2 (en) | 2011-12-22 | 2016-03-15 | Previvo Genetics, Llc | Recovery and processing of human embryos formed in vivo |
US20170128695A1 (en) * | 2013-05-29 | 2017-05-11 | Paul Speiser | Three lumen balloon catheter apparatus |
US20140378752A1 (en) * | 2013-06-21 | 2014-12-25 | Previvo Genetics, Llc | Uterine lavage for embryo retrieval |
US9364638B2 (en) | 2014-01-21 | 2016-06-14 | Cook Medical Technologies Llc | Adjustable vaginal anchor for uterine tamponade device and methods of using the same |
US11065146B2 (en) | 2014-11-24 | 2021-07-20 | Meditrina, Inc. | Systems and methods for permanent female contraception |
US10456019B2 (en) * | 2015-09-18 | 2019-10-29 | John Parry | Assessing fallopian tubal patency |
EP3938020A1 (en) * | 2019-03-15 | 2022-01-19 | Covidien LP | Devices for transcervical treatment of endometrial cancer and hyperplasia |
US20200305742A1 (en) * | 2019-03-27 | 2020-10-01 | Kamran Ghodsian | System and method for child-birth monitoring and assistance |
Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4351342A (en) * | 1981-06-10 | 1982-09-28 | Wiita Bruce E | Balloon catheter |
US5303719A (en) * | 1992-08-14 | 1994-04-19 | Wilk Peter J | Surgical method and associated instrument assembly |
Family Cites Families (46)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS5967969A (en) * | 1982-10-12 | 1984-04-17 | 住友ベークライト株式会社 | Cathetel stayed in cervical canal |
US5104377A (en) | 1989-08-10 | 1992-04-14 | C. R. Bard, Inc. | Uterine access device with automatic cervical adjustment |
US5352435A (en) | 1989-12-22 | 1994-10-04 | Unger Evan C | Ionophore containing liposomes for ultrasound imaging |
US6001335A (en) | 1989-12-22 | 1999-12-14 | Imarx Pharmaceutical Corp. | Contrasting agents for ultrasonic imaging and methods for preparing the same |
US5420176A (en) | 1990-06-01 | 1995-05-30 | Imarx Pharmaceutical Corp. | Contrast media for ultrasonic imaging |
US5562099A (en) | 1990-10-05 | 1996-10-08 | Massachusetts Institute Of Technology | Polymeric microparticles containing agents for imaging |
US5487390A (en) | 1990-10-05 | 1996-01-30 | Massachusetts Institute Of Technology | Gas-filled polymeric microbubbles for ultrasound imaging |
GB9106673D0 (en) | 1991-03-28 | 1991-05-15 | Hafslund Nycomed As | Improvements in or relating to contrast agents |
US5205290A (en) | 1991-04-05 | 1993-04-27 | Unger Evan C | Low density microspheres and their use as contrast agents for computed tomography |
DK0586524T3 (en) | 1991-06-03 | 1997-05-20 | Nycomed Imaging As | |
US5188595A (en) * | 1991-06-28 | 1993-02-23 | Laserscope | Method for enhanced retention of balloon catheter in body cavity |
ES2135466T3 (en) | 1992-03-06 | 1999-11-01 | Nycomed Imaging As | IMPROVEMENTS INTRODUCED IN CONTRAST AGENTS. |
US5674468A (en) | 1992-03-06 | 1997-10-07 | Nycomed Imaging As | Contrast agents comprising gas-containing or gas-generating polymer microparticles or microballoons |
WO1994006477A1 (en) | 1992-09-16 | 1994-03-31 | Holmes, Michael, John | Improvements in or relating to contrast agents |
US5370618A (en) | 1992-11-20 | 1994-12-06 | World Medical Manufacturing Corporation | Pulmonary artery polyurethane balloon catheter |
GB9318288D0 (en) | 1993-09-03 | 1993-10-20 | Nycomed Imaging As | Improvements in or relating to contrast agents |
ATE261744T1 (en) | 1994-01-06 | 2004-04-15 | Scimed Life Systems Inc | BALLOON CATHETER WITH THERMOPLASTIC POLYIMIDE BALLOON |
NO940711D0 (en) | 1994-03-01 | 1994-03-01 | Nycomed Imaging As | Preparation of gas-filled microcapsules and contrast agents for diagnostic imaging |
US5437629A (en) * | 1994-04-14 | 1995-08-01 | Bei Medical Systems | Fluid delivery system for hysteroscopic endometrial ablation |
US5800493A (en) | 1995-04-26 | 1998-09-01 | Gynecare, Inc. | Intrauterine ablation system |
US6705323B1 (en) | 1995-06-07 | 2004-03-16 | Conceptus, Inc. | Contraceptive transcervical fallopian tube occlusion devices and methods |
US6165442A (en) | 1996-02-19 | 2000-12-26 | Nycomed Imaging As | Thermally stabilized ultrasound contrast agent |
US6080129A (en) | 1996-12-23 | 2000-06-27 | Conceptus, Inc. | Method and apparatus for performing hysterosalpingography |
US5935098A (en) | 1996-12-23 | 1999-08-10 | Conceptus, Inc. | Apparatus and method for accessing and manipulating the uterus |
US5911252A (en) | 1997-04-29 | 1999-06-15 | Cassel; Douglas | Automated syringe filling system for radiographic contrast agents and other injectable substances |
US5935137A (en) | 1997-07-18 | 1999-08-10 | Gynecare, Inc. | Tubular fallopian sterilization device |
US6290672B1 (en) * | 1997-07-30 | 2001-09-18 | Mick Abae | Exploratory tubular sonogenic catheter |
IL121516A0 (en) | 1997-08-11 | 1998-02-08 | Novadent Ltd | Catheter |
US6012342A (en) | 1997-12-29 | 2000-01-11 | Cobe Cardiovascular Operating Co., Inc. | Plunger assembly for measuring occlusion pressure on a flexible tube |
US6709667B1 (en) | 1999-08-23 | 2004-03-23 | Conceptus, Inc. | Deployment actuation system for intrafallopian contraception |
US6585687B1 (en) | 2000-03-27 | 2003-07-01 | Cordis Corporation | Inflatable balloon catheter body construction |
US6648906B2 (en) | 2000-04-06 | 2003-11-18 | Innercool Therapies, Inc. | Method and apparatus for regulating patient temperature by irrigating the bladder with a fluid |
US6758831B2 (en) | 2001-09-24 | 2004-07-06 | Ethicon, Inc. | Device and method for aligning with the tubal ostium |
PL374188A1 (en) | 2002-05-09 | 2005-10-03 | Ultrast Llc | Medium for contrast enhancement use for ultrasonic, endoscopic and other medical examinations |
JP2006518649A (en) | 2003-02-24 | 2006-08-17 | ピーエルシー システムズ インク. | Methods and systems for the prevention of contrast media nephropathy |
US8048086B2 (en) | 2004-02-25 | 2011-11-01 | Femasys Inc. | Methods and devices for conduit occlusion |
US8052669B2 (en) | 2004-02-25 | 2011-11-08 | Femasys Inc. | Methods and devices for delivery of compositions to conduits |
US20050240211A1 (en) | 2004-04-21 | 2005-10-27 | Stefan Sporri | Apparatus and method for selectably treating a fallopian tube |
US8123693B2 (en) * | 2005-06-20 | 2012-02-28 | Conceptus, Inc. | Methods and devices for determining lumen occlusion |
US7918863B2 (en) | 2005-06-24 | 2011-04-05 | Conceptus, Inc. | Minimally invasive surgical stabilization devices and methods |
US20080167664A1 (en) * | 2006-12-12 | 2008-07-10 | Cytyc Corporation | Method and apparatus for verifying occlusion of fallopian tubes |
US9259233B2 (en) * | 2007-04-06 | 2016-02-16 | Hologic, Inc. | Method and device for distending a gynecological cavity |
US20090306538A1 (en) | 2008-05-06 | 2009-12-10 | Kamran Siminou | Use of a scalar value to assess neurological status |
US10070888B2 (en) | 2008-10-03 | 2018-09-11 | Femasys, Inc. | Methods and devices for sonographic imaging |
KR101647048B1 (en) | 2009-01-14 | 2016-08-09 | 삼성전자주식회사 | Method and apparatus for displaying information of living body |
US8434489B2 (en) | 2009-10-23 | 2013-05-07 | Conceptus, Inc. | Contraceptive devices and methods |
-
2009
- 2009-10-09 US US12/577,108 patent/US8585616B2/en not_active Expired - Fee Related
-
2010
- 2010-10-05 WO PCT/US2010/051515 patent/WO2011044155A1/en active Application Filing
-
2013
- 2013-09-30 US US14/042,047 patent/US8777876B2/en not_active Expired - Fee Related
-
2014
- 2014-06-26 US US14/316,466 patent/US20140309561A1/en not_active Abandoned
Patent Citations (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4351342A (en) * | 1981-06-10 | 1982-09-28 | Wiita Bruce E | Balloon catheter |
US5303719A (en) * | 1992-08-14 | 1994-04-19 | Wilk Peter J | Surgical method and associated instrument assembly |
Also Published As
Publication number | Publication date |
---|---|
US20140031634A1 (en) | 2014-01-30 |
US8585616B2 (en) | 2013-11-19 |
US20110087109A1 (en) | 2011-04-14 |
US8777876B2 (en) | 2014-07-15 |
WO2011044155A1 (en) | 2011-04-14 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |
|
AS | Assignment |
Owner name: BAYER HEALTHCARE LLC, NEW JERSEY Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:BAYER ESSURE INC.;REEL/FRAME:036283/0050 Effective date: 20150711 |