Hysterosalpingography and selective salpingography

• US 5,372,584 A
• Filed: 06/24/1993
• Issued: 12/13/1994
• Est. Priority Date: 06/24/1993
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ovamed Corporation
• Inventors: Smelser, Ricci, Decaria, Chris, Schenken, Robert S., Zink, John N., Kagan, Jonathan
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): CERMAK, ADAM
• Application Number:
  US08/083,133
• Time in Patent Office: 537 Days
• Field of Search: 604/54, 604/55, 604/174, 604/176, 604/178, 604/96-103, 606/192, 606/193, 606/119, 128/778, 128/656-658, 600/35
• US Class Current: 604/515
• CPC Class Codes: A61B 10/0291 for uterus A61B10/0045 takes precedence
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

An apparatus to establish access into the uterus and the fallopian tubes of a female for diagnostic or therapeutic procedures includes a cervical access catheter, an ostial access catheter insertable through the cervical access catheter, and a fallopian access catheter insertable through the ostial access catheter. The cervical access catheter incorporates a distally located intrauterine balloon which is inflatable after insertion into the uterus. The cervical access catheter also incorporates a cervical retention disk which can be slid into position against the anterior lip of the cervix to anchor the cervical access catheter into the cervical canal between the intrauterine balloon and the cervical disk. Once the cervical access catheter is properly anchored, the ostial access catheter is inserted through the cervical access catheter. The ostial access catheter has a guidable distal portion which, after the distal portion has passed through the cervical access catheter, can be positioned into the ostium of the fallopian tube. If desired, a contrast media can then be injected through the ostial access catheter. Further, if additional information is required, the fallopian access catheter can be inserted through the ostial access catheter and advanced into the fallopian tube for injection of a contrast media directly into the fallopian tube.

Claims

1. An apparatus for establishing access to the uterus and fallopian tube of a female which comprises:

cervical access means for establishing a working channel through the cervix into the uterus, said cervical access means being anchorable in the cervical canal for establishing fluid tight extracorporeal access into the uterus through said working channel;

ostial access means for establishing access into the ostium of a fallopian tube, said ostial access means being selectively insertable through said working channel of said cervical access means, said ostial access means formed with a lumen and having a distal end with a distal end portion adjacent said distal end, and having a proximal end with a proximal end portion adjacent said proximal end, said ostial access means being guidable to position said distal end thereof into the ostium of the fallopian tube;

fallopian access means for establishing access into the fallopian tube, said fallopian access means being selectively insertable through said lumen of said ostial access means for advancement of said fallopian access means into the fallopian tube; and

an O-ring mounted in said proximal portion of said ostial access means to establish a fluid seal between said ostial access means and said fallopian access means.

2. An apparatus as recited in claim 1 wherein said cervical access means is an elongated cervical access catheter having a distal end with a distal end portion adjacent thereto and having a proximal end with a proximal end portion adjacent thereto, and wherein said working channel extends through said cervical access catheter and wherein said cervical access catheter further comprises:

an inflatable intrauterine balloon located on said distal end portion of said cervical access catheter for passage through the cervical canal and inflation in the uterus;

a cervical retention disk slidably mounted on said cervical access catheter;

a fixation member attached to said cervical retention disk, said fixation member being slidably mounted on said cervical access catheter to position said disk against the anterior lip of the cervix while said inflatable balloon is in the uterus; and

a locking mechanism mounted on said fixation member to selectively grip said cervical access catheter for holding said fixation member in place on said cervical access catheter.

3. An apparatus as recited in claim 2 wherein said cervical access catheter further comprises:

an inflation lumen having a distal end and a proximal end, said distal end of said inflation lumen being connected with said inflatable intrauterine balloon for fluid communication therebetween;

a pilot balloon assembly connected in fluid communication with said proximal end of said inflation lumen;

a check valve connected in fluid communication with said pilot balloon assembly; and

an inflation syringe engageable with said check valve for simultaneously inflating said intrauterine balloon and said pilot balloon.

4. An apparatus as recited in claim 2 wherein said cervical access catheter includes a fluid seal mounted in said working channel in said proximal portion of said cervical access catheter to establish a fluid barrier between said cervical access catheter and said ostial access means and wherein said ostial access means is an ostial access catheter insertable through said working channel of said cervical access catheter to extend said distal end portion of said ostial access catheter beyond said distal end of said cervical access catheter, said distal end portion of said ostial access catheter being guidable for placement of said distal end of said ostial access catheter against the ostium of the fallopian tube.

5. An apparatus for establishing fluid communication with the uterus and fallopian tube of a female which comprises:

an elongated cervical access catheter for accessinq the cervix, said cervical access catheter being anchorable in the cervical canal for establishing extracorporeal access into the uterus, said cervical access catheter being formed with a working channel having a distal end with a distal portion adjacent thereto and having a proximal end with a proximal end portion adjacent thereto, said working channel extending through said cervical access catheter;

a first sealing means for establishing a fluid tight seal for said cervical access catheter, said first sealing means being mounted in said proximal portion of said working channel of said cervical access catheter;

an inflatable intrauterine balloon located on said distal end portion of said cervical access catheter for passage through the cervical canal and inflation in the uterus;

a cervical disk slidably mounted on said cervical access catheter;

a fixation member formed with said cervical disk, said fixation member being slidably mounted on said cervical access catheter to position said disk against the anterior lip of the cervix while said inflatable balloon is in the uterus;

a locking mechanism mounted on said fixation member to selectively grip said cervical access catheter for holding said fixation member in place on said cervical access catheter;

a first fluid source selectively engageable in fluid communication with said working channel;

an ostial access catheter for establishing access to the ostium of a fallopian tube, formed with a lumen, said ostial access catheter having a distal end and a distal end portion adjacent said distal end thereof and a proximal end and a proximal end portion adjacent said proximal end thereof, said ostial access catheter being insertable through said first sealing means into said working channel of said cervical access catheter to extend said distal end portion of said ostial access catheter beyond said distal portion of said cervical access catheter, said distal end portion of said ostial access catheter being preformed for guidable placement of said distal end of said ostial access catheter against the ostium of the fallopian tube;

a second sealing means for establishing a fluid tight seal for said ostial access catheter, said second sealing means being mounted in said proximal portion of said lumen; and

a second fluid source selectively engageable in fluid communication with said lumen of said ostial access catheter.

6. An apparatus as recited in claim 5 further comprising:

a fallopian access catheter for establishing access to the fallopian tubes, formed with a lumen, having a distal end and a proximal end, said fallopian access catheter being insertable through said second sealing means into said lumen of said ostial access catheter to extend said distal end of said fallopian access catheter beyond said distal end of said ostial access catheter, through the ostium of the fallopian tube and into the fallopian tube; and

a third fluid source selectively engageable in fluid communication with said lumen of said fallopian access catheter.

7. An apparatus as recited in claim 6 wherein said cervical access catheter further comprises:

an inflation lumen having a distal end and a proximal end, said distal end of said inflation lumen being connected with said inflatable intrauterine balloon for fluid communication therebetween;

a pilot balloon assembly connected in fluid communication with said proximal end of said inflation lumen;

a check valve connected in fluid communication with said pilot balloon assembly; and

an inflation syringe engageable with said check valve for simultaneously inflating said intrauterine balloon and said pilot balloon.

8. An apparatus as recited in claim 7 wherein said first sealing means is a Quad-ring mounted in said working channel in said proximal portion of said cervical access catheter to establish a fluid seal between said cervical access catheter and said ostial access catheter, and said second sealing means is an O-ring mounted in said lumen in said proximal portion of said ostial access catheter to establish a fluid seal between said ostial access catheter and said fallopian access catheter.

9. A method for establishing fluid communication with the uterus and fallopian tubes of a female using an apparatus including a fluid source, an elongated cervical access catheter for establishing access to the cervix, formed with a working channel, an inflatable intrauterine balloon located distally on said cervical access catheter, a check valve connected in fluid communication with said balloon, a fixation member formed with a cervical retention disk and having a manipulable locking mechanism, said fixation member being slidably mounted on said cervical access catheter;

an ostial access catheter for establishing access to the ostium of a fallopian tube, formed with a first lumen, said ostial access catheter being insertable through said working channel of said cervical access catheter and said ostial access catheter having a guidable distal end portion for placement of said distal end portion;

a fallopian access catheter for establishing access to the fallopian tubes, formed with a second lumen, said fallopian access catheter being insertable through said lumen of said ostial access catheter;

a fluid tight seal in said cervical access catheter working channel to establish a fluid barrier between said cervical access catheter and said ostial access catheter; and

a fluid tight seal in said lumen of said ostial access catheter to establish a fluid barrier between said ostial access catheter and said fallopian access catheter;

said method comprising the steps of;

inserting said intrauterine balloon through the cervical canal and into the uterus;

inflating said intrauterine balloon;

positioning said retention disk of said fixation member against the anterior lip of the cervix;

anchoring said cervical access catheter in the cervical canal by manipulating said locking mechanism of said fixation member; and

selectively engaging said fluid source in fluid communication with one of said working channel, said first lumen, or said second lumen, to inject fluid into the uterus or the fallopian tube.

10. A method as recited in claim 9 further comprising the steps of:

inserting said ostial access catheter through said working channel of said cervical access catheter;

Positioning said distal portion of said ostial access catheter against the ostium of a fallopian tube; and

selectively engaging said fluid source in fluid communication with said lumen of said ostial access catheter for injection of fluid into the fallopian tube.

11. A method as recited in claim 10 further comprising the steps of:

inserting said fallopian access catheter through said lumen of said ostial access catheter for advancing a portion of said fallopian access catheter into the fallopian tube; and

connecting said source of contrast media with said lumen of said fallopian access catheter for selective injection of fluid into the fallopian tube.

12. A method as recited in claim 9 wherein said apparatus includes a pilot balloon assembly located proximally on said cervical access catheter with an inflation lumen connecting said intrauterine balloon in fluid communication with said pilot balloon, and said method further comprises the steps of:

connecting an inflation syringe to said check valve for inflation of said intrauterine balloon; and

observing inflation of said pilot balloon for a visual indication of inflation of said intrauterine balloon.

13. An apparatus for establishing access to the uterus and fallopian tube of a female which comprises:

an elongated cervical access catheter for establishing a working channel through the cervix into the uterus, wherein said working channel extends through said cervical access catheter, said cervical access catheter having a distal end with a distal end portion adjacent thereto and having a proximal end with a proximal end portion adjacent thereto, said cervical access catheter being anchorable in the cervical canal for establishing fluid tight extracorporeal access into the uterus through said working channel;

an inflatable intrauterine balloon located on said distal end portion of said cervical access catheter for passage through the cervical canal and inflation in the uterus;

a cervical retention disk slidably mounted on said cervical access catheter;

a fixation member attached to said cervical retention disk, said fixation member being slidably mounted on said cervical access catheter to position said disk against the anterior lip of the cervix while said inflatable balloon is in the uterus;

a locking mechanism mounted on said fixation member to selectively grip said cervical access catheter for holding said fixation member in place on said cervical access catheter;

an ostial access catheter for establishing access into the ostium of a fallopian tube, said ostial access catheter being selectively insertable through said working channel of said cervical access catheter to extend said distal end portion of said ostial access catheter beyond said distal end of said cervical access catheter, said ostial access catheter formed with a lumen and having a distal end with a distal end portion adjacent said distal end, and having a proximal end with a proximal end portion adjacent said proximal end, said ostial access catheter being guidable to position said distal end thereof into the ostium of the fallopian tube;

a fluid seal mounted in said working channel in said proximal portion of said cervical access catheter to establish a fluid barrier between said cervical access catheter and said ostial access catheter;

fallopian access means for establishing access into the fallopian tube, said fallopian access means being selectively insertable through said lumen of said ostial access catheter for advancement of said fallopian access means into the fallopian tube; and

an O-ring mounted in said lumen in said distal portion of said ostial access catheter to establish a fluid seal between said ostial access catheter and said fallopian access means.

14. An apparatus as recited in claim 13 wherein said fallopian access means is a fallopian access catheter formed with a lumen having a distal end and a proximal end, said fallopian access catheter being insertable through said lumen of said ostial access catheter to extend said distal end of said fallopian access catheter beyond said distal end of said ostial access catheter, through the ostium of the fallopian tube and into the fallopian tube.

15. An apparatus as recited in claim 14 further comprising a fluid source selectively engageable with said working channel of said cervical assess catheter for injecting fluids into the uterus.

16. An apparatus as recited in claim 14 further comprising a fluid source selectively engageable with said lumen of said ostial access catheter for injecting fluids into the fallopian tube.

17. An apparatus as recited in claim 14 further comprising a fluid source selectively engageable with said lumen of said fallopian access catheter for injecting fluids into the fallopian tube.

18. An apparatus as recited in claim 14 further comprising a fluid access line attached to said cervical access catheter to establish fluid communication with said working channel, said fluid access line being joined in fluid communication with said working channel distally from said fluid seal.

19. An apparatus for establishing fluid communication with the uterus and fallopian tube of a female which comprises:

an elongated cervical access catheter for accessing the cervix, said cervical access catheter being anchorable in the cervical canal for establishing extracorporeal access into the uterus, said cervical access catheter being formed with a working channel having a distal end with a distal portion adjacent thereto and having a proximal end with a proximal end portion adjacent thereto, said working channel extending through said cervical access catheter;

an inflatable intrauterine balloon located on said distal end portion of said cervical access catheter for passage through the cervical canal and inflation in the uterus;

a cervical disk slidably mounted on said cervical access catheter;

a fixation member formed with said cervical disk, said fixation member being slidably mounted on said cervical access catheter to position said disk against the anterior lip of the cervix while said inflatable balloon is in the uterus;

a locking mechanism mounted on said fixation member having manipulable locking mechanism to selectively grip said cervical access catheter for holding said fixation member in place on said cervical access catheter;

a first fluid source selectively engageable in fluid communication with said working channel;

an ostial access catheter for establishing access to the ostium of a fallopian tube, formed with a lumen, said ostial access catheter having a distal end and a distal end portion adjacent said distal end thereof and a proximal end and a proximal end portion adjacent said proximal end thereof, said ostial access catheter being insertable through said first sealing means into said working channel of said cervical access catheter to extend said distal end portion of said ostial access catheter beyond said distal portion of said cervical access catheter, said distal end portion of said ostial access catheter being preformed for guidable placement of said distal end of said ostial access catheter against the ostium of the fallopian tube;

a second fluid source selectively engageable in fluid communication with said lumen of said ostial access catheter;

a fallopian access catheter for establishing access to the fallopian tubes, formed with a lumen, having a distal end and a proximal end, said fallopian access catheter being insertable through said second sealing means into said lumen of said ostial access catheter to extend said distal end of said fallopian access catheter beyond said distal end of said ostial access catheter, through the ostium of the fallopian tube and into the fallopian tube;

a third fluid source selectively engageable in fluid communication with said lumen of said fallopian access catheter;

an inflation lumen having a distal end and a proximal end, said distal end of said inflation lumen being connected with said inflatable intrauterine balloon for fluid communication therebetween;

a pilot balloon assembly connected in fluid communication with said proximal end of said inflation lumen;

a check valve connected in fluid communication with said pilot balloon assembly;

an inflation syringe engageable with said check valve for simultaneously inflating said intrauterine balloon and said pilot balloon;

a fluid sealing means mounted in said working channel in said proximal portion of said cervical access catheter to establish a fluid seal between said cervical access catheter and said ostial access catheter; and

an O-ring mounted in said lumen in said proximal portion of said ostial access catheter to establish a fluid seal between said ostial access catheter and said fallopian access catheter.