US5935098A — Apparatus and method for accessing and manipulati…

Claim 1

Independent Claim 145 words

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, wherein the sleeve catheter includes an atraumatic occluding member near its distal end; introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while the occluding member on the sleeve catheter engages outside the cervix; inflating the balloon to seal against the cervix; introducing contrast media through the inner catheter into the uterus; imaging the uterus; and 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.

Claim 2

Independent Claim 145 words

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, wherein the sleeve catheter includes an atraumatic occluding member near its distal end; introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while the occluding member on the sleeve catheter engages outside the cervix; inflating the balloon to seal against the cervix; introducing contrast media through the inner catheter into the uterus; imaging the uterus; and 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.

Claim 3

Dependent Claim 61 words

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 the os at the entrance to a fallopian tube.

Claim 4

Dependent Claim 24 words

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

Claim 5

Dependent Claim 26 words

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 6

Dependent Claim 24 words

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 7

Dependent Claim 44 words

A method as in claim 1, 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 8

Dependent Claim 55 words

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 9

Dependent Claim 36 words

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 10

Dependent Claim 139 words

A uterine access catheter system comprising: an inner catheter having a proximal end, a distal end, an access lumen therebetween, and an inflatable balloon near the distal end; a sleeve catheter having a proximal end, a distal end, and a lumen therebetween sized to slidably receive the inner catheter, wherein the length of the sleeve catheter is less than the length of the inner catheter by at least 5 cm so that the distal end of the inner catheter can be introduced through a patient's cervix while the distal end of the sleeve catheter remains outside of the cervix; and an occluding member on the distal end of the sleeve catheter adapted to engage against the outside of a cervical os when the inner catheter passes through the cervix and the sleeve catheter is placed over the inner catheter.

Claim 11

Dependent Claim 139 words

A uterine access catheter system comprising: an inner catheter having a proximal end, a distal end, an access lumen therebetween, and an inflatable balloon near the distal end; a sleeve catheter having a proximal end, a distal end, and a lumen therebetween sized to slidably receive the inner catheter, wherein the length of the sleeve catheter is less than the length of the inner catheter by at least 5 cm so that the distal end of the inner catheter can be introduced through a patient's cervix while the distal end of the sleeve catheter remains outside of the cervix; and an occluding member on the distal end of the sleeve catheter adapted to engage against the outside of a cervical os when the inner catheter passes through the cervix and the sleeve catheter is placed over the inner catheter.

Claim 12

Dependent Claim 38 words

A uterine access catheter system as in claim 9, wherein the inner catheter further includes a hub at its proximal end, wherein the sleeve catheter may be introduced and removed over the distal end of the inner catheter.

Claim 13

Dependent Claim 89 words

A uterine access catheter system as in claim 10, wherein the inner catheter has an outside diameter in the range from 1 mm to 2.5 mm and a lumen diameter in the range from 0.5 mm to 1.5 mm, a length from 25 cm to 40 cm, and wherein the sleeve catheter has a lumen diameter in the range from 2 mm to 4 mm, an outside diameter in the range from 3 mm to 4.5 mm, and a length in the range from 15 cm to 25 cm.

Claim 14

Dependent Claim 31 words

A uterine access catheter system, as in claim 11, wherein the distal balloon is elastomeric and can be inflated to a width in the range from 10 mm to 15 mm.

Claim 15

Dependent Claim 48 words

A uterine access catheter system, as in claim 9, wherein the inner catheter is composed of a soft material having a hardness in the range from 65D to 75D, and the sleeve catheter is composed of a material having a hardness in the range from 70D to 80D.

Claim 16

Dependent Claim 22 words

A uterine access catheter system as in claim 9, wherein the stiffening rod is malleable over at least a distal portion thereof.

Claim 17

Dependent Claim 15 words

A uterine access catheter system as in claim 9, wherein the stiffening rod is resilient.

Claim 18

Dependent Claim 20 words

A uterine access catheter system as in claim 9, wherein the sleeve catheter is more rigid than the inner catheter.

Claim 19

Dependent Claim 20 words

A uterine access catheter system as in claim 9, wherein the sleeve catheter comprises a handle at its proximal end.

Claim 20

Dependent Claim 16 words

A uterine access catheter system as in claim 17, wherein the handle comprises a connectable fitting.

Claim 21

Independent Claim 176 words

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, wherein the sleeve catheter includes an atraumatic occluding member near its distal end; introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while the occluding member on the sleeve catheter engages outside the cervix; inflating the balloon to seal against the cervix; introducing contrast media through the inner catheter into the uterus; imaging 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 passing a falloposcope through a lumen of the fallopian catheter; and imaging the fallopian tube using the falloposcope.

Claim 22

Independent Claim 176 words

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, wherein the sleeve catheter includes an atraumatic occluding member near its distal end; introducing the catheter assembly through the patient's vagina so that the balloon is positioned past the cervix and in the uterus while the occluding member on the sleeve catheter engages outside the cervix; inflating the balloon to seal against the cervix; introducing contrast media through the inner catheter into the uterus; imaging 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 passing a falloposcope through a lumen of the fallopian catheter; and imaging the fallopian tube using the falloposcope.

Claim 23

Dependent Claim 24 words

A method as in claim 19, further comprising introducing contrast media through the fallopian catheter into the fallopian tube; and imaging the fallopian tube.

Claim 24

Dependent Claim 41 words

A method as in claim 19, further comprising advancing the sleeve catheter into the uterus; removing the inner catheter from the lumen of the sleeve catheter; and infusing of aspirating a fluid or material through the sleeve catheter into the uterus.

Claim 25

Dependent Claim 55 words

A method as in claim 19, 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 26

Dependent Claim 36 words

A method as in claim 22, 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 27

Independent Claim 136 words

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, (2) a sleeve catheter disposed coaxially over the inner catheter, wherein the sleeve catheter includes an atraumatic occluding member near its distal end, and (3) a stiffening rod that is removably received in a lumen of the inner catheter; introducing the catheter assembly through the patient's vagina with the stiffening rod in place in the inner catheter lumen so that the balloon is positioned past the cervix and in the uterus while the occluding member on the sleeve catheter engages outside the cervix; inflating the balloon to seal against the cervix; removing the stiffening rod; and introducing contrast media through the inner catheter into the uterus; imaging the uterus.

Claim 28

Independent Claim 136 words

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, (2) a sleeve catheter disposed coaxially over the inner catheter, wherein the sleeve catheter includes an atraumatic occluding member near its distal end, and (3) a stiffening rod that is removably received in a lumen of the inner catheter; introducing the catheter assembly through the patient's vagina with the stiffening rod in place in the inner catheter lumen so that the balloon is positioned past the cervix and in the uterus while the occluding member on the sleeve catheter engages outside the cervix; inflating the balloon to seal against the cervix; removing the stiffening rod; and introducing contrast media through the inner catheter into the uterus; imaging the uterus.

Claim 29

Dependent Claim 61 words

A method as in claim 24, 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 30

Dependent Claim 26 words

A method as in claim 24, further comprising: passing a falloposcope through a lumen of the fallopian catheter; and imaging the fallopian tube using the falloposcope.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2002-08-09	2003-02-08	2003-08-10	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2006-08-09	2007-02-08	2007-08-10	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2010-08-09	2011-02-08	2011-08-10	$7700.00	Window Closed / Lapsed

Apparatus and method for accessing and manipulating the uterus

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