# US 6,080,129 A · Method and apparatus for performing hysterosalpingography

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- Number: US 6,080,129 A
- Document ID: US6080129A
- Status: Granted
- Kind: A
- Application number: 08/772,395
- Filed: 1996-12-23
- Granted: 2000-06-27
- Earliest claimed: 1996-12-23
- Assignees: Conceptus, Inc.
- Inventors: Michael W. Blaisdell
- Web page: https://patentgrep.com/patent/US6080129A

## CPC

- A61M 31/005: {for contrast media}
- A61B 2017/4216: {Operations on uterus, e.g. endometrium}
- A61B 2017/4233: {Operations on Fallopian tubes, e.g. sterilization (A61B2017/1125 takes precedence)}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61M 2210/1425: Uterine tubes
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A uterine access catheter system comprises an inner catheter and a catheter sleeve slidably disposed over the inner catheter. Initial access to the uterus is accomplished by positioning the inner catheter through the cervix with the sleeve remaining outside of the cervix. After inflating a balloon near the distal end of the inner catheter, contrast media can be injected and hysterosalpingography performed. Should the initial hysterosalpingography be unsuccessful, direct access to the fallopian tubes can be achieved by further inserting the sleeve catheter through the cervix, removing the inner catheter, and utilizing a uterine catheter and fallopian catheter for accessing the fallopian tubes.

## Claims

### Claim 1

A method for performing hysterosalpingography on a patient, said method comprising:
providing a catheter assembly including (1) an inner catheter having a balloon near its distal end and (2) a sleeve catheter disposed coaxially over the inner catheter;
introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while a distal end of the sleeve catheter remains outside of and proximal to the cervix;
inflating the balloon to seal against the cervix;
introducing contrast media through the inner catheter into the uterus;
imaging the uterus;
advancing a distal end of the sleeve catheter over the inner catheter through the cervix and into the uterus; and
withdrawing the inner catheter from the sleeve catheter to leave an access lumen in the sleeve catheter through the cervix into the uterus.

### Claim 2 (depends on 1)

A method as in claim 1, further comprising:
introducing a uterine catheter through the lumen of the sleeve catheter and into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removal from the sleeve catheter; and
guiding a distal end of the uterine catheter to a fallopian os at the entrance to a fallopian tube.

### Claim 3 (depends on 2)

A method as in claim 2, further comprising:
passing a fallopian catheter through a lumen of the uterine catheter and into the fallopian tube, wherein the uterine catheter remains within the sleeve catheter.

### Claim 4 (depends on 3)

A method as in claim 3, further comprising:
passing a falloposcope through a lumen of the fallopian catheter; and
imaging the fallopian tube using the falloposcope.

### Claim 5 (depends on 3)

A method as in claim 3, further comprising
introducing contrast media through the fallopian catheter into the fallopian tube; and
imaging the fallopian tube.

### Claim 6 (depends on 1)

A method as in claim 1, further comprising infusing or aspirating a fluid or material through a lumen of the sleeve catheter into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removed from the lumen of the sleeve catheter.

### Claim 7 (depends on 1)

A method as in claim 1, wherein the catheter system further comprises a stiffening rod that is removably received in a lumen of the inner catheter, wherein the stiffening rod is in place when the catheter system is introduced through the vagina and cervix and is removed prior to introducing contact media into the uterus.

### Claim 8 (depends on 7)

A method as in claim 7, wherein the stiffening rod is malleable and further comprising shaping a portion of the stiffening rod so that the inner catheter assumes a shape selected to match the patient's anatomy.

### Claim 9

A method for performing hysterosalpingography on a patient, said method comprising:
providing a catheter assembly including (1) an inner catheter having a balloon near its distal end and (2) a sleeve catheter disposed coaxially over the inner catheter;
introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while a distal end of the sleeve catheter remains outside of and proximal to the cervix;
inflating the balloon to seal against the cervix;
introducing contrast media through the inner catheter into the uterus;
imaging the uterus;
optionally advancing a distal end of the sleeve catheter over the inner catheter through the cervix and optionally withdrawing the inner catheter from the sleeve catheter to leave an access lumen in the sleeve catheter through the cervix into the uterus;
introducing a uterine catheter through the lumen of the sleeve catheter and into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removal from the sleeve catheter; and
guiding a distal end of the uterine catheter to the os at the entrance to a fallopian tube.

### Claim 10 (depends on 9)

A method as in claim 9, further comprising:
passing a fallopian catheter through a lumen of the uterine catheter and into the fallopian tube.

### Claim 11 (depends on 10)

A method as in claim 10, further comprising:
passing a falloposcope through a lumen of the fallopian catheter; and
imaging the fallopian tube using the falloposcope.

### Claim 12 (depends on 10)

A method as in claim 10, further comprising
introducing contrast media through the fallopian catheter into the fallopian tube; and
imaging the fallopian tube.

### Claim 13 (depends on 9)

A method as in claim 9, further comprising infusing of aspirating a fluid or material through the sleeve catheter into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removed from the lumen of the sleeve catheter.

### Claim 14 (depends on 9)

A method as in claim 9, wherein the catheter system further comprises a stiffening rod that is removably received in a lumen of the inner catheter, wherein the stiffening rod is in place when the catheter system is introduced through the vagina and cervix and is removed prior to introducing contact media into the uterus.

### Claim 15 (depends on 14)

A method as in claim 14, wherein the stiffening rod is malleable and further comprising shaping a portion of the stiffening rod so that the inner catheter assumes a shape selected to match the patient's anatomy.

### Claim 16

A method for performing hysterosalpingography on a patient, said method comprising:
providing a catheter assembly including (1) an inner catheter having a balloon near its distal end and (2) a sleeve catheter disposed coaxially over the inner catheter;
introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while a distal end of the sleeve catheter remains outside of and proximal to the cervix;
inflating the balloon to seal against the cervix;
introducing contrast media through the inner catheter into the uterus;
imaging the uterus;
optionally advancing a distal end of the sleeve catheter over the inner catheter through the cervix and optionally withdrawing the inner catheter from the sleeve catheter to leave an access lumen in the sleeve catheter through the cervix into the uterus; and
infusing of aspirating a fluid or material through the sleeve catheter into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removed from the lumen of the sleeve catheter.

### Claim 17 (depends on 16)

A method as in claim 16, further comprising:
introducing a uterine catheter through the lumen of the sleeve catheter and into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removal from the sleeve catheter; and
guiding a distal end of the uterine catheter to the Os at the entrance to a fallopian tube.

### Claim 18 (depends on 17)

A method as in claim 17, further comprising:
passing a fallopian catheter through a lumen of the uterine catheter and into the fallopian tube.

### Claim 19 (depends on 18)

A method as in claim 18, further comprising:
passing a falloposcope through a lumen of the fallopian catheter; and
imaging the fallopian tube using the falloposcope.

### Claim 20 (depends on 18)

A method as in claim 18, further comprising
introducing contrast media through the fallopian catheter into the fallopian tube; and
imaging the fallopian tube.

### Claim 21 (depends on 16)

A method as in claim 16, wherein the catheter system further comprises a stiffening rod that is removably received in a lumen of the inner catheter, wherein the stiffening rod is in place when the catheter system is introduced through the vagina and cervix and is removed prior to introducing contact media into the uterus.

### Claim 22 (depends on 21)

A method as in claim 21, wherein the stiffening rod is malleable and further comprising shaping a portion of the stiffening rod so that the inner catheter assumes a shape selected to match the patient's anatomy.

### Claim 23

A method for performing hysterosalpingography on a patient, said method comprising:
providing a catheter assembly including (1) an inner catheter having a balloon near its distal end and (2) a sleeve catheter disposed coaxially over the inner catheter;
introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while a distal end of the sleeve catheter remains outside of and proximal to the cervix;
inflating the balloon to seal against the cervix;
introducing contrast media through the inner catheter into the uterus;
imaging the uterus;
optionally advancing a distal end of the sleeve catheter over the inner catheter through the cervix and withdrawing the inner catheter from the sleeve catheter to leave an access lumen in the sleeve catheter through the cervix into the uterus; and
a stiffening rod that is removably received in a lumen of the inner catheter, wherein the stiffening rod is in place when the catheter system is introduced through the vagina and cervix and thereafter removed.

### Claim 24 (depends on 23)

A method as in claim 23, further comprising:
introducing a uterine catheter through the lumen of the sleeve catheter and into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removal from the sleeve catheter; and
guiding a distal end of the uterine catheter to the os at the entrance to a fallopian tube.

### Claim 25 (depends on 24)

A method as in claim 24, further comprising:
passing a fallopian catheter through a lumen of the uterine catheter and into the fallopian tube.

### Claim 26 (depends on 25)

A method as in claim 25, further comprising:
passing a falloposcope through a lumen of the fallopian catheter; and
imaging the fallopian tube using the falloposcope.

### Claim 27 (depends on 25)

A method as in claim 25, further comprising
introducing contrast media through the fallopian catheter into the fallopian tube; and
imaging the fallopian tube.

### Claim 28 (depends on 23)

A method as in claim 23, further comprising infusing of aspirating a fluid or material through the sleeve catheter into the uterus after the sleeve catheter has been advanced into the uterus and the inner catheter removed from the lumen of the sleeve catheter.

### Claim 29 (depends on 23)

A method as in claim 23, wherein the stiffening rod is malleable and further comprising shaping a portion of the stiffening rod so that the inner catheter assumes a shape selected to match the patient's anatomy.
