US5021043A — Method and catheter for dilatation of the lacrima…

Claim 1

Independent Claim 60 words

A method of restoring patency to an obstructed portion of the lacrimal system of a patient, comprising: providing a catheter having an inflatable member; inserting the catheter into the lacrimal system; positioning the inflatable member in the obstructed portion of the lacrimal system; and inflating the inflatable member to dilate the obstructed portion to restore patencY to the lacrimal system.

Claim 2

Independent Claim 60 words

A method of restoring patency to an obstructed portion of the lacrimal system of a patient, comprising: providing a catheter having an inflatable member; inserting the catheter into the lacrimal system; positioning the inflatable member in the obstructed portion of the lacrimal system; and inflating the inflatable member to dilate the obstructed portion to restore patencY to the lacrimal system.

Claim 3

Dependent Claim 45 words

The method of claim 1 wherein the provided catheter includes a visually perceivable marker having a known spaced relationship to one of the ends of the inflatable member, and positioning the inflated member includes aligning the marker relative to an opening into the lacrimal system.

Claim 4

Dependent Claim 17 words

The method of claim 2 wherein the marker is aligned relative to a punctum of the patient.

Claim 5

Dependent Claim 21 words

The method of claim 2 wherein the marker is aligned relative to the opening of the nasolacrimal duct into the nose.

Claim 6

Dependent Claim 22 words

The method of claim 2 wherein the marker is aligned relative to an ostium formed between the nose and the lacrimal sac.

Claim 7

Dependent Claim 51 words

The method of claim 1 wherein the provided catheter includes a lumen for receiving a guidewire, and inserting the catheter includes: passing a guidewire through a first opening into the lacrimal system, through the obstruction, and out a second opening of the lacrimal system; and advancing the catheter over the guidewire.

Claim 8

Dependent Claim 47 words

The method of claim 6 wherein advancing the catheter further includes positioning the distal end of the catheter proximate to the first opening, interlocking the proximal end of the catheter relative to the guidewire, and pulling the guidewire to draw the inflatable member into the lacrimal system.

Claim 9

Dependent Claim 28 words

The method of claim 6 further including initially passing a probe through the lacrimal system to determine a path between the first and second openings through the obstruction.

Claim 10

Dependent Claim 26 words

The method of claim 8 further including withdrawing the probe, installing a sleeve along the path, advancing the guidewire through the sleeve, and withdrawing the sleeve.

Claim 11

Dependent Claim 31 words

The method of claim 9 wherein installing the sleeve includes advancing the sleeve with a relatively rigid core along the path, and withdrawing the core while leaving the sleeve in position.

Claim 12

Dependent Claim 35 words

The method of claim 1 wherein inflating includes applying fluid under pressure to the balloon for a first period of time, deflating the balloon, and applying fluid under pressure for a second period of time.

Claim 13

Dependent Claim 18 words

The method of claim 11 wherein the first and second period of time are between 5-15 minutes each.

Claim 14

Independent Claim 186 words

A method of restoring patency to an obstructed portion of the lacrimal system of a patient, comprising: providing a catheter including: a catheter body having a proximal end and a distal end; an inflatable member formed of noncompliant material and disposed proximate to the distal end of the catheter body, the inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, the distal region attached to the distal end of the center region and the proximal tapered region attached to the proximal end of the center region; and at least one visually perceivable marker having a known spaced relationship from one of the distal end and the proximal end of the center region for enabling alignment of the inflatable member with the obstructed portion of the lacrimal system to be dilated; inserting the catheter into the lacrimal system; positioning the inflatable member in the obstructed portion of the lacrimal system by aligning the marker relative to an opening into the lacrimal system; and inflating the inflatable member to dilate the obstructed portion to restore patency to the lacrimal system.

Claim 15

Independent Claim 186 words

A method of restoring patency to an obstructed portion of the lacrimal system of a patient, comprising: providing a catheter including: a catheter body having a proximal end and a distal end; an inflatable member formed of noncompliant material and disposed proximate to the distal end of the catheter body, the inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, the distal region attached to the distal end of the center region and the proximal tapered region attached to the proximal end of the center region; and at least one visually perceivable marker having a known spaced relationship from one of the distal end and the proximal end of the center region for enabling alignment of the inflatable member with the obstructed portion of the lacrimal system to be dilated; inserting the catheter into the lacrimal system; positioning the inflatable member in the obstructed portion of the lacrimal system by aligning the marker relative to an opening into the lacrimal system; and inflating the inflatable member to dilate the obstructed portion to restore patency to the lacrimal system.

Claim 16

Dependent Claim 51 words

The method of claim 13 wherein the provided catheter includes a lumen for receiving a guidewire, and inserting the catheter includes: passing a guidewire through a first opening into the lacrimal system, through the obstruction, and out a second opening of the lacrimal system; and advancing the catheter over the guidewire.

Claim 17

Dependent Claim 47 words

The method of claim 14 wherein advancing the catheter further includes positioning the distal end of the catheter proximate to the first opening, interlocking the proximal end of the catheter relative to the guidewire, and pulling the guidewire to draw the inflatable member into the lacrimal system.

Claim 18

Dependent Claim 28 words

The method of claim 15 further including initially passing a probe through the lacrimal system to determine a path between the first and second openings through the obstruction.

Claim 19

Dependent Claim 48 words

The method of claim 16 further including: withdrawing the probe; installing a sleeve along the path by advancing the sleeve with a relatively rigid core along the path, and withdrawing the core while leaving the sleeve in position; advancing the guidewire through the sleeve; and withdrawing the sleeve.

Claim 20

Dependent Claim 29 words

The method of claim 13 wherein the catheter is inserted through a punctum and associated canaliculus, and then through an ostium formed between the nose and the lacrimal sac.

Claim 21

Dependent Claim 38 words

The method of claim 18 wherein a first visually perceivable marker is spaced 9-13 mm proximal to the proximal end of the center region, and positioning the inflatable member includes aligning the first marker relative to the punctum.

Claim 22

Dependent Claim 49 words

The method of claim 19 wherein the inflatable member is translucent, a second visually perceivable marker is located beneath the inflatable member at a distance of 4-6 mm distal to the proximal end of the center region, and positioning further includes aligning the second marker relative to the ostium.

Claim 23

Dependent Claim 63 words

The method of claim 13 wherein the catheter is inserted through an ostium formed between the nose and the lacrimal sac, and then through a canaliculus and its associated punctum, and a first visually perceivable marker is spaced 9-13 mm distal to the distal end of the center region, and positioning the inflatable member includes aligning the first marker relative to the punctum.

Claim 24

Dependent Claim 49 words

The method of claim 21 wherein the inflatable member is translucent, a second visually perceivable marker is located beneath the inflatable member at a distance of 4-6 mm proximal to the distal end of the center region, and positioning further includes aligning a second marker relative to the ostium.

Claim 25

Dependent Claim 22 words

The method of claim 13 wherein the catheter is inserted through a punctum and associated canaliculus, and then through the nasolacrimal duct.

Claim 26

Dependent Claim 56 words

The method of claim 23 wherein the inflatable member is translucent, a first visually perceivable marker is located beneath the inflatable member at a distance of 4-6 mm proximal to the distal end of the center region, and positioning further includes aligning the first marker relative to the opening of the nasolacrimal duct into the nose.

Claim 27

Dependent Claim 38 words

The method of claim 24 wherein a second visually perceivable marker is spaced 9-16 mm proximal to the proximal end of the center region, and positioning the inflatable member includes aligning the second marker relative to the punctum.

Claim 28

Dependent Claim 57 words

The method of claim 25 wherein the second marker is located 9-11 mm from the proximal end of the center region, and the catheter further includes a third marker located 14-16 mm proximal to the proximal end of the center region, and positioning the inflatable member includes aligning the second and third markers relative to the punctum.

Claim 29

Dependent Claim 43 words

The method of claim 26 in which a first dilatation is performed after the first marker is aligned relative to the opening of the nasolacrimal duct, and a second dilatation is performed after aligning the second and third markers relative to the punctum.

Claim 30

Dependent Claim 21 words

The method of claim 13 wherein the catheter is inserted through a punctum and associated canaliculus for dilatation of the canaliculus.

Claim 31

Dependent Claim 38 words

The method of claim 28 wherein a first visually perceivable marker is spaced 9-16 mm proximal to the distal end of the center region, and positioning the inflatable member includes aligning the first marker relative to the punctum.

Claim 32

Dependent Claim 31 words

The method of claim 13 wherein the catheter body of the provided catheter has a distal segment and a proximal segment, the distal segment being more flexible than the proximal segment.

Claim 33

Dependent Claim 14 words

The method of claim 30 wherein the distal segment includes a slender, flexible wire.

Claim 34

Dependent Claim 22 words

The method of claim 13 wherein the provided catheter includes a lubricious coating to facilitate inserting the catheter into the lacrimal system.

Claim 35

Dependent Claim 19 words

The method of claim 32 further including topically applying the coating to the catheter body and the inflatable member.

Claim 36

Dependent Claim 127 words

A catheter for dilating an obstructed portion of the lacrimal system of a patient, comprising: a catheter body having a proximal end and a distal end; an inflatable member disposed proximate to the distal end of said catheter body, said inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, said distal region attached to a distal end of said center region and said proximal tapered region attached to a proximal end of said center region; and at least one visually perceivable marker having a known spaced relationship from one of said distal end and said proximal end of said center region for enabling alignment of said inflatable member with the obstructed portion of the lacrimal system to be dilated.

Claim 37

Dependent Claim 127 words

A catheter for dilating an obstructed portion of the lacrimal system of a patient, comprising: a catheter body having a proximal end and a distal end; an inflatable member disposed proximate to the distal end of said catheter body, said inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, said distal region attached to a distal end of said center region and said proximal tapered region attached to a proximal end of said center region; and at least one visually perceivable marker having a known spaced relationship from one of said distal end and said proximal end of said center region for enabling alignment of said inflatable member with the obstructed portion of the lacrimal system to be dilated.

Claim 38

Dependent Claim 33 words

The catheter of claim 34 wherein a first visually perceivable marker is spaced 9-13 mm proximal to said proximal end of said center region for alignment relative to a punctum of the patient.

Claim 39

Dependent Claim 55 words

The catheter of claim 35 wherein said inflatable member is translucent and a second visually perceivable marker is located beneath said inflatable member at a distance of 4-6 mm distal to said proximal end of said center region for alignment relative to an ostium formed between the nose and the lacrimal sac of the patient.

Claim 40

Dependent Claim 18 words

The catheter of claim 36 in which said inflatable member has a diameter of 3-6 mm when inflated.

Claim 41

Dependent Claim 16 words

The catheter of claim 37 in which said inflatable member has a length of 5-10 mm.

Claim 42

Dependent Claim 32 words

The catheter of claim 34 wherein a first, visually perceivable marker is spaced 9-13 mm distal to said distal end of said center region for alignment with a punctum of the patient.

Claim 43

Dependent Claim 55 words

The catheter of claim 39 wherein said inflatable member is translucent and a second visually perceivable marker is located beneath said inflatable member at a distance of 4-6 mm proximal to said distal end of said center region for alignment relative to an ostium formed between the nose and the lacrimal sac of the patient.

Claim 44

Dependent Claim 50 words

The catheter of claim 34 wherein said inflatable member is translucent and a first visually perceivable marker is located beneath said inflatable member a distance of 4-6 mm proximal to said distal end of said center region for alignment relative to the opening of the nasolacrimal duct into the nose.

Claim 45

Dependent Claim 33 words

The catheter of claim 41 wherein a second visually perceivable marker is spaced 9-16 mm proximal to said proximal end of said center region for alignment relative to a punctum of a patient.

Claim 46

Dependent Claim 17 words

The catheter of claim 41 wherein said inflatable member has a diameter when inflated of 2-5 mm.

Claim 47

Dependent Claim 15 words

The catheter of claim 43 wherein said inflatable member has a length of 15-30 mm.

Claim 48

Dependent Claim 43 words

The catheter of claim 43 wherein said second marker is located 9-11 mm from said proximal end of said center region and said catheter further includes a third visually perceivable marker located 14-16 mm proximal to said proximal end of said center region.

Claim 49

Dependent Claim 38 words

The catheter of claim 34 wherein a first visually perceivable marker is spaced 9-16 mm proximal to said distal end of said center region for alignment relative to a punctum of the patient for dilatation of a canaliculus.

Claim 50

Dependent Claim 17 words

The catheter of claim 46 wherein said inflatable member has a diameter of 2-4 mm when inflated.

Claim 51

Dependent Claim 26 words

The catheter of claim 34 wherein said catheter body defines a first lumen for inflating said inflatable member and a second lumen for receiving a guidewire.

Claim 52

Dependent Claim 27 words

The catheter of claim 34 wherein said catheter body has a distal segment and a proximal segment, the distal segment being more flexible than the proximal segment.

Claim 53

Dependent Claim 14 words

The catheter of claim 49 wherein the distal segment includes a slender, flexible wire.

Claim 54

Dependent Claim 24 words

The catheter of claim 34 further including a lubricious coating disposed on said catheter body to facilitate inserting said catheter into the lacrimal system.

Claim 55

Dependent Claim 160 words

A catheter for dilating an obstructed portion of the lacrimal system of a patient, comprising: a catheter body having a proximal end and a distal end: an inflatable member formed of noncompliant material and disposed proximate to the distal end of said catheter body, said inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, said distal region attached to a distal end of said center region and said proximal tapered region attached to a proximal end of said center region; at least one visually perceivable dilatation marker disposed within said center region of said inflatable member for enabling alignment of said inflatable member with the obstructed portion of the lacrimal system to be dilated; and at least one visually perceivable insertion marker spaced from one of said distal end and said proximal end of said center region for enabling positioning of said inflatable member relative to an opening into the lacrimal system.

Claim 56

Dependent Claim 160 words

A catheter for dilating an obstructed portion of the lacrimal system of a patient, comprising: a catheter body having a proximal end and a distal end: an inflatable member formed of noncompliant material and disposed proximate to the distal end of said catheter body, said inflatable member having when inflated a center region, a distal tapered region and a proximal tapered region, said distal region attached to a distal end of said center region and said proximal tapered region attached to a proximal end of said center region; at least one visually perceivable dilatation marker disposed within said center region of said inflatable member for enabling alignment of said inflatable member with the obstructed portion of the lacrimal system to be dilated; and at least one visually perceivable insertion marker spaced from one of said distal end and said proximal end of said center region for enabling positioning of said inflatable member relative to an opening into the lacrimal system.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	1994-06-03	1994-12-03	1995-06-04	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	1998-06-03	1998-12-03	1999-06-04	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2002-06-03	2002-12-03	2003-06-04	$7700.00	Window Closed / Lapsed

Method and catheter for dilatation of the lacrimal system

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