US5868768A
Expired / Lapsed
US
⏱️ 0.0 years remaining
Method and device for endoluminal disruption of venous valves
Assignee: Edwards Lifesciences Corp
•
Filing: 1997-04-04
•
Granted: 1999-02-09
•
Expires: 2017-04-04
Abstract
Abstract A method and device for cutting venous valve located within the lumen of a vein. The device comprises an elongate shaft of rigid or flexible construction and a valvulotome blade positioned on the distal end of said elongate shaft. The valvulotome blade comprises an elongate shank portion which is disposed substantially parallel to the longitudinal axis of the shaft, and a head portion which extends laterally from the shank portion of the blade. The head portion of the blade comprises an outer venous wall abutment surface and a proximal cutting surface. The venous wall abutting surface is a spaced distance from the proximal cutting surface such that the venous wall abutment surface may be forced into abutment with the venous wall and the device may be drawn through a venous valve such that the proximal cutting surface will cut the venous valve, but will not come into contact with the adjacent vein wall. The device may incorporate a mechanism, such as a protruding loop of wire, which will abut against the blood vessel wall so as to force the venous wall abutment surface of the valvulotome blade against the opposite wall of the vein or during the venous valve cutting procedure. The method of the invention provides for operation of the device to effect cutting of venous valve, and may be performed concurrently with an in situ side branch occlusion procedure. The method is preferably performed under angioscopic guidance, and the angioscope used for guidance of the method may be integrated with a separate side branch occlusion device to facilitate concurrent performance of the side branch occlusion procedure and the venous valve cutting procedure.
Inventors
- 👤 Jan Wicherski
- 👤 Stephen A. Sosnowski
Bibliographic Details
Application Number
—
Jurisdiction
US
Data Source
google_patents
Last Synchronized
2026-10-23 11:41
CPC Classifications
A; A61; A61B; A61B17/00; A61B17/32; A61B17/3205; A61B17/3207; A61B17/32075; A61B17/320016; A61B17/320036; A61B17/22; A61B2017/22097
Claims Analysis
Total Claims: 41
Claim 1
Independent Claim
228 words
A valvulotome device for cutting venous valves within the lumen of a vein, said device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; an elongate control member extending longitudinally through the lumen of said shaft; a valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body, and a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve; wherein said proximally retracted position and distally extended position extend along the same longitudinal axis.
Claim 2
Dependent Claim
228 words
A valvulotome device for cutting venous valves within the lumen of a vein, said device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; an elongate control member extending longitudinally through the lumen of said shaft; a valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body, and a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve; wherein said proximally retracted position and distally extended position extend along the same longitudinal axis.
Claim 3
Dependent Claim
13 words
The device of claim 1 wherein said shaft comprises a rigid tubular cannula.
Claim 4
Dependent Claim
14 words
The device of claim 1 wherein said shaft comprises a pliable tubular catheter body.
Claim 5
Dependent Claim
83 words
The device of claim 1 further comprising: a handpiece located at the proximal end of said shaft, said handpiece having a moveable actuator which is connected to the proximal end of said control member such that movement of said actuator in the proximal direction will cause said control wire and said valvulotome blade to move in the proximal direction, and movement of said actuator in the distal direction will cause said control wire and said valvulotome blade to move in the distal direction.
Claim 6
Dependent Claim
33 words
The device of claim 1 further comprising: a fluid infusion inlet fluidly connected to said lumen of said shaft member such that fluid may be infused through the lumen of said shaft member.
Claim 7
Dependent Claim
60 words
The device of claim 5 wherein said fluid infusion inlet comprises: a fluid infusion tube connected to the shaft member, said fluid infusion tube having a lumen formed therein in communication with said lumen of said shaft member, said fluid infusion tube being connectable to a fluid source to facilitate passage of fluid through the lumen of said shaft member.
Claim 8
Dependent Claim
82 words
The device of claim 1 wherein said valvulotome blade further comprises: a venous wall abutment surface formed on the outer surface of the head portion of said valvulotome blade, said venous wall abutment surface being a spaced distance from said proximal cutting edge such that, when said venous wall abutment surface is placed in contact with the luminal wall of a vein, said proximal cutting surface will be maintained a distance of 0.020-0.025 inches away from said luminal wall of said vein.
Claim 9
Dependent Claim
56 words
The device of claim 7 wherein said venous wall abutment surface is of a smooth, generally convex configuration such that, said venous wall abutment surface may be placed in abutting contact with the luminal wall of the vein, and longitudinally moved while maintaining said abutting contact, without causing trauma to the luminal wall of said vein.
Claim 10
Dependent Claim
115 words
The device of claim 1 further comprising: a lateral slot opening formed in said shaft near the distal end thereof, and forming a lateral passage out of the lumen in which said control member is positioned; and, a retainer member mounted in said shaft, said retainer member being configured and constructed to prevent said valvulotome blade from moving in the distal direction beyond a distal limit point; said lateral slot opening and said retainer member thereby cooperating to cause a portion of said control member to bulge in a first direction out of said lateral slot aperture upon continued distal advancement of said control member after said valvulotome blade has reached its distal limit point.
Claim 11
Dependent Claim
22 words
The device of claim 1 wherein said elongate control member comprises a wire which extends longitudinally through the lumen of said shaft.
Claim 12
Dependent Claim
33 words
The device of claim 10 wherein said wire comprises: a longitudinal wire core member; and, an outer wire coil member tightly helically wound around the outer surface of said longitudinal wire core member.
Claim 13
Dependent Claim
215 words
A valvulotome device for cutting venous valves within the lumen of a vein, said device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; a single elongate control member extending longitudinally through the lumen of said shaft; a single valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body, and a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve.
Claim 14
Dependent Claim
215 words
A valvulotome device for cutting venous valves within the lumen of a vein, said device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; a single elongate control member extending longitudinally through the lumen of said shaft; a single valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body, and a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve.
Claim 15
Dependent Claim
13 words
The device of claim 12 wherein said shaft comprises a rigid tubular cannula.
Claim 16
Dependent Claim
14 words
The device of claim 12 wherein said shaft comprises a pliable tubular catheter body.
Claim 17
Dependent Claim
83 words
The device of claim 12 further comprising: a handpiece located at the proximal end of said shaft, said handpiece having a moveable actuator which is connected to the proximal end of said control member such that movement of said actuator in the proximal direction will cause said control wire and said valvulotome blade to move in the proximal direction, and movement of said actuator in the distal direction will cause said control wire and said valvulotome blade to move in the distal direction.
Claim 18
Dependent Claim
33 words
The device of claim 12 further comprising: a fluid infusion inlet fluidly connected to said lumen of said shaft member such that fluid may be infused through the lumen of said shaft member.
Claim 19
Dependent Claim
60 words
The device of claim 16 wherein said fluid infusion inlet comprises: a fluid infusion tube connected to the shaft member, said fluid infusion tube having a lumen formed therein in communication with said lumen of said shaft member, said fluid infusion tube being connectable to a fluid source to facilitate passage of fluid through the lumen of said shaft member.
Claim 20
Dependent Claim
82 words
The device of claim 12 wherein said valvulotome blade further comprises: a venous wall abutment surface formed on the outer surface of the head portion of said valvulotome blade, said venous wall abutment surface being a spaced distance from said proximal cutting edge such that, when said venous wall abutment surface is placed in contact with the luminal wall of a vein, said proximal cutting surface will be maintained a distance of 0.020-0.025 inches away from said luminal wall of said vein.
Claim 21
Dependent Claim
56 words
The device of claim 18 wherein said venous wall abutment surface is of a smooth, generally convex configuration such that, said venous wall abutment surface may be placed in abutting contact with the luminal wall of the vein, and longitudinally moved while maintaining said abutting contact, without causing trauma to the luminal wall of said vein.
Claim 22
Dependent Claim
115 words
The device of claim 12 further comprising: a lateral slot opening formed in said shaft near the distal end thereof, and forming a lateral passage out of the lumen in which said control member is positioned; and, a retainer member mounted in said shaft, said retainer member being configured and constructed to prevent said valvulotome blade from moving in the distal direction beyond a distal limit point; said lateral slot opening and said retainer member thereby cooperating to cause a portion of said control member to bulge in a first direction out of said lateral slot aperture upon continued distal advancement of said control member after said valvulotome blade has reached its distal limit point.
Claim 23
Dependent Claim
22 words
The device of claim 12 wherein said elongate control member comprises a wire which extends longitudinally through the lumen of said shaft.
Claim 24
Dependent Claim
33 words
The device of claim 21 wherein said wire comprises: a longitudinal wire core member; and, an outer wire coil member tightly helically wound around the outer surface of said longitudinal wire core member.
Claim 25
Dependent Claim
273 words
A valvulotome device for cutting venous valves within the lumen of a vein, said device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; an elongate control member extending longitudinally through the lumen of said shaft; a valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising: an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body and having an inner edge; a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon, said cutting edge having a concave configuration; a venous wall abutment surface formed on the outer surface of the head portion of said valvulotome blade, with the cutting edge extending from the inner edge of the shank portion to a location which is a spaced distance from the outer-most extent of the venous wall abutment surface; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve.
Claim 26
Dependent Claim
273 words
A valvulotome device for cutting venous valves within the lumen of a vein, said device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; an elongate control member extending longitudinally through the lumen of said shaft; a valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising: an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body and having an inner edge; a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon, said cutting edge having a concave configuration; a venous wall abutment surface formed on the outer surface of the head portion of said valvulotome blade, with the cutting edge extending from the inner edge of the shank portion to a location which is a spaced distance from the outer-most extent of the venous wall abutment surface; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve.
Claim 27
Dependent Claim
13 words
The device of claim 23 wherein said shaft comprises a rigid tubular cannula.
Claim 28
Dependent Claim
14 words
The device of claim 23 wherein said shaft comprises a pliable tubular catheter body.
Claim 29
Dependent Claim
83 words
The device of claim 23 further comprising: a handpiece located at the proximal end of said shaft, said handpiece having a moveable actuator which is connected to the proximal end of said control member such that movement of said actuator in the proximal direction will cause said control wire and said valvulotome blade to move in the proximal direction, and movement of said actuator in the distal direction will cause said control wire and said valvulotome blade to move in the distal direction.
Claim 30
Dependent Claim
33 words
The device of claim 23 further comprising: a fluid infusion inlet fluidly connected to said lumen of said shaft member such that fluid may be infused through the lumen of said shaft member.
Claim 31
Dependent Claim
60 words
The device of claim 27 wherein said fluid infusion inlet comprises: a fluid infusion tube connected to the shaft member, said fluid infusion tube having a lumen formed therein in communication with said lumen of said shaft member, said fluid infusion tube being connectable to a fluid source to facilitate passage of fluid through the lumen of said shaft member.
Claim 32
Dependent Claim
59 words
The device of claim 23 wherein said venous wall abutment surface is a spaced distance from said proximal cutting edge such that, when said venous wall abutment surface is placed in contact with the luminal wall of a vein, said proximal cutting surface will be maintained a distance of 0.020-0.025 inches away from said luminal wall of said vein.
Claim 33
Dependent Claim
56 words
The device of claim 29 wherein said venous wall abutment surface is of a smooth, generally convex configuration such that, said venous wall abutment surface may be placed in abutting contact with the luminal wall of the vein, and longitudinally moved while maintaining said abutting contact, without causing trauma to the luminal wall of said vein.
Claim 34
Dependent Claim
115 words
The device of claim 23 further comprising: a lateral slot opening formed in said shaft near the distal end thereof, and forming a lateral passage out of the lumen in which said control member is positioned; and, a retainer member mounted in said shaft, said retainer member being configured and constructed to prevent said valvulotome blade from moving in the distal direction beyond a distal limit point; said lateral slot opening and said retainer member thereby cooperating to cause a portion of said control member to bulge in a first direction out of said lateral slot aperture upon continued distal advancement of said control member after said valvulotome blade has reached its distal limit point.
Claim 35
Dependent Claim
22 words
The device of claim 23 wherein said elongate control member comprises a wire which extends longitudinally through the lumen of said shaft.
Claim 36
Dependent Claim
33 words
The device of claim 32 wherein said wire comprises: a longitudinal wire core member; and, an outer wire coil member tightly helically wound around the outer surface of said longitudinal wire core member.
Claim 37
Independent Claim
468 words
A method for cutting venous valves within the lumen of a vein, said method comprising the steps of: a) providing a device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; an elongate control member extending longitudinally through the lumen of said shaft; a valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body, and a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve; b) causing said valvulotome blade of said device to be positioned in its proximally retracted position; c) inserting the elongate shaft of said device, distal end first, into the vein wherein said venous valves are to be cut; d) positioning said device such that the distal end of said shaft is slightly upstream of a first venous valve to be cut; e) moving the valvulotome blade to its distally extended position, and causing the blade to be positioned such that the head portion of said valvulotome blade is located downstream of the venous valve; f) moving the device in the proximal direction such that the proximal cutting edge of the valvulotome blade cuts a portion of said first venous valve; g) returning the valvulotome blade of said device to its proximally retracted position; h) rotating the device approximately 180°; i) positioning the device such that the distal end of the elongate shaft is slightly upstream of said first venous valve; j) moving the valvulotome blade of the device to its distally extended position such that the head portion of said valvulotome blade is positioned upstream of said venous valve; k) moving the device in the proximal direction such that the proximal cutting edge of said valvulotome blade cuts said first venous valve, thereby rendering said venous valve fully incompetent; and 1) concurrently positioning an angioscope within the vein and using the angioscope to visualize the positioning and use of said device during said cutting of said venous valves.
Claim 38
Independent Claim
468 words
A method for cutting venous valves within the lumen of a vein, said method comprising the steps of: a) providing a device comprising: an elongate shaft having a proximal end, a distal end, a longitudinal axis, and a lumen extending longitudinally therethrough; an elongate control member extending longitudinally through the lumen of said shaft; a valvulotome blade positioned on the distal end of said shaft and connected to the distal end of said control member, said valvulotome blade comprising an elongate shank portion which extends substantially parallel to the longitudinal axis of said shaft body, and a head portion which protrudes to one side of said shank portion, said head portion having a proximal cutting edge formed thereon; said valvulotome blade and said control member being longitudinally moveable, back and forth, relative to said shaft, such that said blade is alternately positionable in: i. a proximally retracted position wherein the proximal cutting edge of said blade is shielded by the distal end of said shaft; and, ii. a distally extended position wherein the proximal cutting edge of said blade is located a spaced distance ahead of the distal end of said shaft such that retraction of said blade, in the proximal direction, through a venous valve will cause the proximal cutting edge of said blade to cut said venous valve; b) causing said valvulotome blade of said device to be positioned in its proximally retracted position; c) inserting the elongate shaft of said device, distal end first, into the vein wherein said venous valves are to be cut; d) positioning said device such that the distal end of said shaft is slightly upstream of a first venous valve to be cut; e) moving the valvulotome blade to its distally extended position, and causing the blade to be positioned such that the head portion of said valvulotome blade is located downstream of the venous valve; f) moving the device in the proximal direction such that the proximal cutting edge of the valvulotome blade cuts a portion of said first venous valve; g) returning the valvulotome blade of said device to its proximally retracted position; h) rotating the device approximately 180°; i) positioning the device such that the distal end of the elongate shaft is slightly upstream of said first venous valve; j) moving the valvulotome blade of the device to its distally extended position such that the head portion of said valvulotome blade is positioned upstream of said venous valve; k) moving the device in the proximal direction such that the proximal cutting edge of said valvulotome blade cuts said first venous valve, thereby rendering said venous valve fully incompetent; and 1) concurrently positioning an angioscope within the vein and using the angioscope to visualize the positioning and use of said device during said cutting of said venous valves.
Claim 39
Dependent Claim
85 words
The method of claim 34 wherein said angioscope is incorporated into a side branch blocking device, said side branch blocking device being operative to effect in situ blocking of side branches which emanate from said vein, and wherein said method of claim 34 is performed in conjunction with the in situ blocking of said side branches, and wherein the angioscope incorporated into said side branch blocking device being used to visually observe both the side branch blocking procedure and the cutting of said venous valves.
Claim 40
Dependent Claim
122 words
The method of claim 34, further comprising the step of providing said device with: a lateral slot opening formed in said shaft near the distal end thereof, and forming a lateral passage out of the lumen in which said control member is positioned; and, a retainer member mounted in said shaft, said retainer member being configured and constructed to prevent said valvulotome blade from moving in the distal direction beyond a distal limit point; said lateral slot opening and said retainer member thereby cooperating to cause a portion of said control member to bulge in a first direction out of said lateral slot aperture upon continued distal advancement of said control member after said valvulotome blade has reached its distal limit point.
Claim 41
Dependent Claim
137 words
The method of claim 36, wherein the performance of steps E and F of said method further comprise causing a portion of said control member to protrude out of said lateral slot opening and into contact with the luminal wall of the vein so as to force the venous wall abutment surface of the head portion of the valvulotome blade into contact with the luminal surface of the vein during the performance during steps E and F of said method, and wherein the performance of step G of said method further comprises causing said control member to be retracted into said lateral slot opening and into the shaft of said device, thereby terminating the forcing of said venous wall abutment surface of the said head portion of the valvulotome blade against the luminal surface of the vein.
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USPTO Annuity & Maintenance Windows
| Annuity Stage | Window Opens | Payment Deadline | Surcharge Period Until | Estimated Fee | Status |
|---|---|---|---|---|---|
| 3.5 Years (Year 4) | 2002-02-08 | 2002-08-10 | 2003-02-09 | $2000.00 | Window Closed / Lapsed |
| 7.5 Years (Year 8) | 2006-02-08 | 2006-08-10 | 2007-02-09 | $3760.00 | Window Closed / Lapsed |
| 11.5 Years (Year 12) | 2010-02-08 | 2010-08-10 | 2011-02-09 | $7700.00 | Window Closed / Lapsed |