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US20040225257A1 - Single lumen balloon catheter apparatus - Google Patents

Single lumen balloon catheter apparatus Download PDF

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Publication number
US20040225257A1
US20040225257A1 US10869221 US86922104A US2004225257A1 US 20040225257 A1 US20040225257 A1 US 20040225257A1 US 10869221 US10869221 US 10869221 US 86922104 A US86922104 A US 86922104A US 2004225257 A1 US2004225257 A1 US 2004225257A1
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Prior art keywords
catheter
balloon
fluid
uterus
end
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US10869221
Inventor
Bernard Ackerman
Original Assignee
Bernard Ackerman
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0175Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1052Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector

Abstract

A catheter useful for non-surgical entry into a uterus to dispense a diagnostic fluid therein. The catheter includes a tubular body having a lumen extending from a first end thereof to a second end thereof. The lumen includes an external opening adjacent the first end for dispensing a diagnostic fluid into the interior of a subject uterus, and a balloon disposed marginally adjacent to the first end of the body for fluid sealing the interior of the subject uterus. The lumen further includes a second opening in fluid communication with the interior of the balloon for inflation thereof with the diagnostic fluid. In most applications, the catheter can be combined with a syringe to form a catheter apparatus.

Description

    FIELD OF THE INVENTION
  • [0001]
    The present invention relates to catheters, and in particular, to a balloon-bearing single lumen catheter for injecting diagnostic fluids into a body cavity and a catheter apparatus employing same.
  • BACKGROUND OF THE INVENTION
  • [0002]
    Diagnostic procedures which require a non-surgical entry into the uterus are well known. One such procedure known as hysterosalpingography, is a radiographic method for imaging the anatomical structures of the uterus and fallopian tubes. Hysterosalpingography involves inserting a fine flexible catheter through the cervical canal and injecting a contrast medium, such as an iodinated fluid, into the uterus. Radiography is then carried out to provide imaging information pertaining to the subject uterus.
  • [0003]
    Another well known diagnostic procedure which entails the non-surgical entry into the uterus is called hysterosonography. This procedure also employs a fine flexible catheter that is inserted into the cervical canal of the uterus. The catheter in this procedure enables the physician or technician to inject a sterile saline solution into the uterus to expand it so that an ultrasound scanner can be used to sonographically observe the uterus.
  • [0004]
    The catheters used in both procedures typically have means for sealing off the uterus after injection of the fluid to prevent backflow into the vaginal canal. One such means includes an inflatable intrauterine balloon made from an elastomeric material disposed adjacent the distal tip of the catheter. The catheter includes a first lumen that communicates with the interior of the balloon to enable inflation and deflation with an inflation syringe, and second lumen that is open at the distal tip of the catheter to enable injection of a desired diagnostic fluid into the uterus with a injection syringe.
  • [0005]
    The balloon catheter is operated by inserting the distal tip thereof through the cervical canal and into the uterus with the intrauterine balloon deflated. The insertion of the distal tip operates to position the deflated intrauterine balloon in the uterus. Once positioned, the inflation syringe is used to inflate the intrauterine balloon with air to seal block the cervical canal and the injection syringe is used to inject the desired diagnostic fluid into the uterus.
  • [0006]
    One problem associated with balloon catheters of this design is that they are relatively expensive to manufacture because they include two lumens and double syringes. Therefore, a less expensive balloon bearing catheter is needed.
  • SUMMARY OF THE INVENTION
  • [0007]
    A catheter used for non-surgically entry into a uterus to dispense a diagnostic fluid therein; the catheter comprising a tubular body having a lumen extending from a first end thereof to a second end thereof. The lumen includes an external opening adjacent the first end for dispensing a diagnostic fluid into the interior of a subject uterus, and a balloon disposed marginally adjacent to the first end of the body for fluid sealing the interior of the subject uterus. The lumen further includes a second opening in fluid communication with the interior of the balloon for inflation thereof with the diagnostic fluid.
  • [0008]
    The catheter is typically combined with a syringe to form a catheter apparatus if desired.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0009]
    The advantages, nature, and various additional features of the invention will appear more fully upon consideration of the illustrative embodiments now to be described in detail in connection with accompanying drawings wherein:
  • [0010]
    [0010]FIG. 1 is an elevational view of a catheter apparatus according to an embodiment of the invention;
  • [0011]
    [0011]FIG. 2 is a sectional view of the catheter of the apparatus;
  • [0012]
    [0012]FIG. 3A is a diagrammatic view of the catheter of the invention anchored in the cervical canal of a subject uterus;
  • [0013]
    [0013]FIG. 3B is a diagrammatic view of the catheter of the invention anchored in the uterine cavity of a subject uterus; and
  • [0014]
    [0014]FIG. 4 is an enlarged diagrammatic view of the distal portion of the catheter of the invention.
  • [0015]
    It should be understood that the drawings are for purposes of illustrating the concepts of the invention and are not necessarily to scale.
  • DETAILED DESCRIPTION OF THE INVENTION
  • [0016]
    [0016]FIG. 1 shows a catheter apparatus according to an embodiment of the invention. The catheter apparatus 10 is an inline assembly comprised of a flexible, single lumen catheter 11 and a conventional syringe 12. The catheter apparatus 10 is primarily intended for non-surgical entry into the uterine cavity, however, one of ordinary skill in the art will recognize its usefulness in other related procedures.
  • [0017]
    The catheter 11 of the apparatus 10 includes a flexible tubular body 16 which is preferably made from a clear polyurethane or like material. The body 16 has a distal end 17 and proximal end 18 and is threadedly disposed in a semi-rigid sheath 13 which is preferably made from polypropylene or any other suitable material. The sheath 13 has a distal end 24, a proximal end 25, and a length which is about 40% percent less than the length of the catheter body 16. The sheath 13 can be slidably moved back and forth along the catheter body 16 to uncover the distal portion of the body 16 to allow it to bend and flex freely or to cover it to prevent bending and flexing thus aiding the insertion of the catheter 11 in the vaginal canal. A conventional female Luer hub connector 14 is provided at the proximal end 18 of the catheter body 16 for detachably fluid coupling the syringe 12 (which should be equipped with a male Luer connector) to the catheter 11. An inflatable balloon 20 (shown in the deflated state) is affixed to and encloses a marginal distal end portion of the body 16. The balloon 20 can be of the type described in U.S. Pat. No. 5,624,399 issued to Bernard Ackerman the disclosure of which is incorporated herein by reference.
  • [0018]
    The balloon 20 taught in U.S. Pat. No. 5,624,399 is typically constructed from an elastomeric material such as polyurethane or any other elastomeric material having a Shure A durometer of between approximately 70 and 95. U.S. Pat. No. 5,624,399 further teaches attaching the balloon 20 to the body 16 so that its longitudinal axis L is longer than its transverse axis T upon initial inflation thereof. This allows the balloon 20 to be progressively transformed from an ellipsoidal shape to a spherical shape with increasing inflation pressure. The balloon 20 in the ellipsoidal shape as shown in FIG. 3A, can be used for occluding the cervical canal 32 of a subject uterus 31 thus preventing obstruction of the uterus 31 during imaging. If pain and/or cramping is experienced with the balloon 20 in the cervical canal 32, it can be moved into the uterine cavity 33 of the subject uterus 31 and further expanded into the spherical shape to block the opening 34 of the cervical canal 32 as shown in FIG. 3B to obviate the pain and/or cramping.
  • [0019]
    It should be understood that other embodiments of the invention can employ more conventional balloon designs. Such balloon designs typically inflate into a spherical shape and are made from latex.
  • [0020]
    [0020]FIG. 2 shows a cross-sectional view through the catheter 11 of the apparatus 10. As can be seen, the body 16 of the catheter 11 is constructed with a single lumen 21 that extends virtually the entire length thereof. The wall 19 of the lumen 21 includes a first slit 22 (best shown in FIG. 4) adjacent to the distal end 17 of the body 16. The first slit 22 allows the lumen 21 to communicate with the external environment to provide a fluid communication path for injecting a diagnostic fluid such as saline or a contrast dye into a the uterine cavity of a subject uterus. The lumen 21 also communicates with the interior of balloon 20 via a second slit 23 (best shown in FIG. 4) provided in the wall 19 of the lumen 21. The second slit 23 is equal to or up to 28 percent larger in area than the first slit 22 to provide a communication path for inflating the balloon 20 with diagnostic fluid as will be explained further on. In other embodiments of the invention, either one or both of the slits 22, 23 can be replaced with a correspondingly placed aperture(s).
  • [0021]
    The apparatus 10 is typically operated by moving the sheath 13 toward the distal end 17 of the catheter 11, to cover the most of the distal portion of the catheter body 16 (the balloon 20 should be deflated). The catheter 11 is then inserted into the vaginal canal so that the distal end 17 of the catheter 11 just enters the cervical canal of a subject uterus and the distal end 24 of the sheath 13 abuts against the end of the cervix. The catheter 11 is then threaded through the sheath 13 to position the balloon 20 in the cervical canal, or just past the cervical canal inside the uterine cavity of the uterus (FIG. 3A).
  • [0022]
    The syringe 12 of the apparatus 10, which is filled with a diagnostic fluid such as saline or a contrast dye, is then operated to inject the diagnostic fluid into the uterine cavity of the uterus. The fluid pressure generated within the lumen 21 by the operation of the syringe 12 causes the first slit 22 at the distal end 17 of the catheter body 16 to open and allow the diagnostic fluid to flow from the catheter 11 into the uterine cavity of the uterus. At the same time as the uterus is being filled with the fluid, back-pressure within the lumen 21 of the catheter 11 caused by restricted fluid flow through the first slit 22 causes the second slit 23 to open to allow fluid to enter and inflate the balloon 20, thus preventing leakage of fluid through the cervical canal.
  • [0023]
    Once the balloon 20 is inflated, the slits 22, 23 operate as check valves by automatically closing to prevent the balloon 20 from deflating. The inflated balloon 20 locks the position of the apparatus 10 and seals the uterine cavity to prevent leakage of the diagnostic fluid therefrom. Radiography or sonography can then be performed to provide imaging information pertaining to the subject uterus or fallopian tubes.
  • [0024]
    When it is desirable to deflate the balloon 20, the syringe 12 is uncoupled from the catheter 11 and the catheter is withdrawn slightly through the cervix. This causes the muscular tissue of the cervix to compress the balloon 20 slightly thus forcing the fluid in the balloon back into the lumen 21 of the catheter 11 through the slit 23. Once the balloon 20 is deflated, the catheter 11 of the apparatus 10 can be fully withdrawn from the uterus through the cervical canal.
  • [0025]
    While the foregoing invention has been described with reference to the above embodiments, various modifications and changes can be made without departing from the spirit of the invention. Accordingly, all such modifications and changes are considered to be within the scope of the appended claims.

Claims (23)

  1. 1. A catheter useful for non-surgical entry into a uterus to dispense a diagnostic fluid therein, the catheter comprising:
    a tubular body having a single lumen extending from a first end thereof to a second end thereof, the lumen having an external opening adjacent the first end for dispensing a diagnostic fluid into the interior of a subject uterus; and
    a balloon disposed marginally adjacent to the first end of the body for fluid sealing the interior of the subject uterus;
    the lumen having a second opening in fluid communication with the interior of the balloon for inflation thereof with the diagnostic fluid;
    wherein the external opening adjacent the first end generates a back-flow within the lumen which causes the fluid to enter and inflate the balloon through the second opening.
  2. 2. The catheter according to claim 1, wherein the body is flexible.
  3. 3. The catheter according to claim 2, further comprising a movable sheath that can be moved to a first position to cover a portion of the body to add rigidity thereto thus aiding in the insertion of the catheter, and which can be moved to a second position to uncover the portion of the body thus allowing it to bend and flex freely.
  4. 4. The catheter according to claim 1, wherein the balloon can be sequentially inflated into first and second predetermined shapes.
  5. 5. The catheter according to claim 4, wherein the first predetermined shape is substantially elliptical and the second predetermined shape is substantially spherical.
  6. 6. The catheter according to claim 4, wherein the balloon is made from polyurethane.
  7. 7. The catheter according to claim 1, wherein the balloon is made from polyurethane.
  8. 8. The catheter according to claim 1, wherein the second opening prevents fluid back-flow in the lumen to maintain inflation of the balloon.
  9. 9. A catheter apparatus useful for non-surgical entry into a uterus to dispense a diagnostic fluid therein, the catheter apparatus comprising:
    a catheter;
    a syringe for delivering the diagnostic fluid into the catheter;
    the catheter having a balloon disposed marginally adjacent to a first end thereof for fluid sealing the interior of the subject uterus, a single lumen extending from the first end to a second end of the catheter, the lumen having an external opening adjacent the first end for dispensing the diagnostic fluid into the interior of a subject uterus and a second opening in fluid communication with the interior of the balloon for inflation thereof with the diagnostic fluid;
    wherein the external opening adjacent the first end generates a back-flow within the lumen which causes the fluid to enter and inflate the balloon through the second opening.
  10. 10. The catheter apparatus according to claim 9, wherein the second opening prevents fluid back-flow in the lumen to maintain inflation of the balloon.
  11. 11. The catheter apparatus according to claim 9, wherein the catheter is flexible.
  12. 12. The catheter apparatus according to claim 11, further comprising a movable sheath that can be moved to a first position to cover a portion of the body to add rigidity thereto thus aiding in the insertion of the catheter, and which can be moved to a second position to uncover the portion of the body thus allowing it to bend and flex freely.
  13. 13. The catheter apparatus according to claim 9, wherein the balloon can be sequentially inflated into first and second predetermined shapes.
  14. 14. The catheter apparatus according to claim 13, wherein the first predetermined shape is substantially elliptical and the second predetermined shape is substantially spherical.
  15. 15. The catheter apparatus according to claim 13, wherein the balloon is made from polyurethane.
  16. 16. The catheter apparatus according to claim 9, wherein the balloon is made from polyurethane.
  17. 17. A method for making a catheter which is useful for non-surgical entry into a uterus to dispense a diagnostic fluid therein, the method comprising the steps of:
    providing a tubular body having a single lumen extending from a first end thereof to a second end thereof,
    creating an external opening adjacent the first end of the body, the external opening for dispensing a diagnostic fluid into the interior of a subject uterus;
    attaching a balloon marginally adjacent to the first end of the body, the balloon for fluid sealing the interior of the subject uterus; and
    creating a second opening in the lumen which is in fluid communication with the interior of the balloon for inflation thereof with the diagnostic fluid.
  18. 18. The method according to claim 17, further comprising the step of providing a syringe that delivers the diagnostic fluid into the catheter, the syringe and the catheter forming a catheter apparatus.
  19. 19. The method according to claim 17, wherein the second opening prevents fluid backflow in the lumen to maintain inflation of the balloon.
  20. 20. The method according to claim 17, wherein the catheter is flexible.
  21. 21. The method according to claim 20, further comprising the step of providing a movable sheath that can be moved to a first position to cover a portion of the body to add rigidity thereto thus aiding in the insertion of the catheter, and which can be moved to a second position to uncover the portion of the body thus allowing it to bend and flex freely.
  22. 22. The catheter according to claim 1, wherein the external opening has a predetermined area and the second opening has a predetermined area, the predetermined area of the second opening being greater than the predetermined area of the external opening.
  23. 23. The catheter apparatus according to claim 9, wherein the external opening has a predetermined area and the second opening has a predetermined area, the predetermined area of the second opening being greater than the predetermined area of the second opening.
US10869221 1999-11-24 2004-06-16 Single lumen balloon catheter apparatus Abandoned US20040225257A1 (en)

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US09449096 US6827703B1 (en) 1999-11-24 1999-11-24 Single lumen balloon catheter apparatus
US10869221 US20040225257A1 (en) 1999-11-24 2004-06-16 Single lumen balloon catheter apparatus

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US10869221 US20040225257A1 (en) 1999-11-24 2004-06-16 Single lumen balloon catheter apparatus

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040193108A1 (en) * 2001-07-03 2004-09-30 Bernard Ackerman Access catheter apparatus for use in minimally invasive surgery and diagnostic procedures in the uterus and fallopian tubes

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US6827703B1 (en) * 1999-11-24 2004-12-07 Coopersurgical, Inc. Single lumen balloon catheter apparatus
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US7549997B2 (en) * 2004-05-28 2009-06-23 Davis Jr Thomas William Body canal dilation system
US8647349B2 (en) 2006-10-18 2014-02-11 Hologic, Inc. Systems for performing gynecological procedures with mechanical distension
US8025656B2 (en) * 2006-11-07 2011-09-27 Hologic, Inc. Methods, systems and devices for performing gynecological procedures
US9392935B2 (en) 2006-11-07 2016-07-19 Hologic, Inc. Methods for performing a medical procedure
US20090270895A1 (en) * 2007-04-06 2009-10-29 Interlace Medical, Inc. Low advance ratio, high reciprocation rate tissue removal device
US9095366B2 (en) 2007-04-06 2015-08-04 Hologic, Inc. Tissue cutter with differential hardness
US8574253B2 (en) 2007-04-06 2013-11-05 Hologic, Inc. Method, system and device for tissue removal
US9259233B2 (en) 2007-04-06 2016-02-16 Hologic, Inc. Method and device for distending a gynecological cavity
WO2010008986A3 (en) * 2008-07-18 2011-04-21 Catharos Medical Systems, Inc. Methods and devices for endovascular introduction of an agent
US9587249B2 (en) * 2008-10-27 2017-03-07 Baxalta GmbH Models of thrombotic thrombocytopenic purpura and methods of use thereof
US9282995B2 (en) 2011-12-22 2016-03-15 Previvo Genetics, Llc Recovery and processing of human embryos formed in vivo
US20150272622A1 (en) 2011-12-22 2015-10-01 Previvo Genetics, Llc Recovery and processing of human embryos formed in vivo
US20130245664A1 (en) * 2012-03-14 2013-09-19 Raggio & Dinnin, P.C. Cervical dilator
CN102657546B (en) * 2012-05-16 2014-05-28 段华 Carrier barrier system applied to prevention and treatment of metrosynizesis
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US3983879A (en) * 1974-07-25 1976-10-05 Western Acadia, Incorporated Silicone catheter
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US5100382A (en) * 1988-10-24 1992-03-31 Valtchev Konstantin L Single channel balloon uterine injector
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US3983879A (en) * 1974-07-25 1976-10-05 Western Acadia, Incorporated Silicone catheter
US3926705A (en) * 1974-07-25 1975-12-16 Western Acadia Silicone catheter and process for manufacturing same
US4089337A (en) * 1976-12-01 1978-05-16 James H. Harris Uterine catheter and manipulator with inflatable seal
US4349732A (en) * 1980-01-07 1982-09-14 The Singer Company Laser spatial stabilization transmission system
US4349033A (en) * 1980-11-06 1982-09-14 Eden Robert D Intrauterine catheter
US4430076A (en) * 1982-02-04 1984-02-07 Harris James H Combined uterine injector and manipulative device
US4489732A (en) * 1982-09-20 1984-12-25 Hasson Harrith M Gynecological instrument
US4921479A (en) * 1987-10-02 1990-05-01 Joseph Grayzel Catheter sheath with longitudinal seam
US5259836A (en) * 1987-11-30 1993-11-09 Cook Group, Incorporated Hysterography device and method
US5423745A (en) * 1988-04-28 1995-06-13 Research Medical, Inc. Irregular surface balloon catheters for body passageways and methods of use
US5100382A (en) * 1988-10-24 1992-03-31 Valtchev Konstantin L Single channel balloon uterine injector
US5147335A (en) * 1989-08-24 1992-09-15 Board Of Regents, The University Of Texas System Transurethrovesical biopsy, amniocentesis and biological sampling guide
US5540658A (en) * 1994-06-27 1996-07-30 Innerdyne, Inc. Transcervical uterine access and sealing device
US5624399A (en) * 1995-09-29 1997-04-29 Ackrad Laboratories, Inc. Catheter having an intracervical/intrauterine balloon made from polyurethane
US6458096B1 (en) * 1996-04-01 2002-10-01 Medtronic, Inc. Catheter with autoinflating, autoregulating balloon
US6827703B1 (en) * 1999-11-24 2004-12-07 Coopersurgical, Inc. Single lumen balloon catheter apparatus

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20040193108A1 (en) * 2001-07-03 2004-09-30 Bernard Ackerman Access catheter apparatus for use in minimally invasive surgery and diagnostic procedures in the uterus and fallopian tubes

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