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WO1997016125A1 - Valvulotomes - Google Patents

Valvulotomes Download PDF

Info

Publication number
WO1997016125A1
WO1997016125A1 PCT/US1996/013836 US9613836W WO9716125A1 WO 1997016125 A1 WO1997016125 A1 WO 1997016125A1 US 9613836 W US9613836 W US 9613836W WO 9716125 A1 WO9716125 A1 WO 9716125A1
Authority
WO
WIPO (PCT)
Prior art keywords
bulb
cutting
leading
vein
diameter
Prior art date
Application number
PCT/US1996/013836
Other languages
English (en)
Inventor
Eric D. Nelson
Original Assignee
W.L. Gore & Associates, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by W.L. Gore & Associates, Inc. filed Critical W.L. Gore & Associates, Inc.
Priority to AU69041/96A priority Critical patent/AU6904196A/en
Publication of WO1997016125A1 publication Critical patent/WO1997016125A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/32075—Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22097—Valve removal in veins

Definitions

  • This invention relates to the field of surgical devices used for vascular surgery and specifically for the disabling of venous valves.
  • proximal and distal are used herein to mean, respectively, nearer to or farther from the heart.
  • proximal and distal are used herein to mean, respectively, nearer to or farther from the heart.
  • ends of the device or components of the device as used in a living vein as the opposite ends of that vein are oriented with respect to the heart.
  • a rod is inserted through the distal incision and through the vein until it exits at the proximal incision.
  • a valve cutter is attached to the rod and a catheter is sutured to the valve cutter. The valve cutter is then drawn into the vein through the proximal incision. Fluid supplied by the catheter keeps the valve leaflets closed during the retrograde motion of the cutter through the vein from proximal to distal sites.
  • valvulotome An early commercially available valvulotome for the disruption of venous valves is the so-called "Mills retrograde valvulotome,” which consists of an elongated rod having an L-shaped end with a bulbous tip and a blade located between the bulbous tip and the elongated portion of the rod and facing in the direction of the elongated rod. The end of the valvulotome is passed through a valve and the instrument is then pulled in the reverse direction, causing the blade to cut through a valve leaflet. With this instrument, two or more passes are necessary for each valve set to insure that both valve leaflets are sufficiently destroyed to permit arterial flow of blood.
  • valvulotomes More recent designs of valvulotomes have evolved from work done by Dr. Peter Samuels into a form best described as a length of rod or cable having a pair of bulbs affixed to the proximal end of the rod or cable, the bulbs being separated by a relatively short length of the rod or cable. Both bulbs and the rod or cable share a common longitudinal axis.
  • the bulb at the very end of the rod or cable is commonly referred to as the cutting bulb and incorporates one or more cutting edges at the end of the cutting bulb opposite the extreme end of the device and closest to the other bulb, which is commonly referred to as the leading bulb.
  • the length of rod or cable /16125
  • both bulbs typically have tapered, pointed proximal ends so that they easily enter and pass through any venous valves encountered, the tapered, pointed bulb ends causing the valve to open around the passing bulbs.
  • the length of the rod or cable with the attached bulbs is then carefully withdrawn. The leading bulb then first encounters each valve. This bulb, having a distal end which is also tapered or pointed, again passes through the valve, this time in a direction opposite to that of normal blood flow through the vein.
  • the leading bulb holds the cutting bulb concentric within the vein with respect to the valve as a function of the respective diameters of the vein and the leading bulb.
  • the venous valve closes behind the leading bulb and around the short length of rod or cable connecting the two bulbs.
  • the cutting edge or edges of the cutting bulb encounter the valve and render the valve incompetent by preferably cutting the valve along its major axis while leaving the least possible amount of valve material attached to the luminal vein surface. This result has been difficult to achieve consistently with presently available devices of this type without also cutting into the lumen of the vein and causing luminal damage.
  • This luminal damage to the vein primarily results from the cutting edge of the cutting bulb catching on tributaries to the vein or on the lumen of the vein as it tapers.
  • the space between the leading bulb and cutting bulb of comrnercially available two-bulb valvulotomes of about 2.5 mm diameter and larger is excessive and the risk of damage to the vein is reduced and the performance of the valvulotome is considerably improved if the space between the two bulbs is less than 3.5 mm and preferably less than about 2.5 mm.
  • this distance should be greater than about 1.3 mm to maintain the cutting ability of the valvulotome.
  • 2.5 mm and larger diameter valvulotomes having this distance less than or equal to 2.5 mm considerably reduce the risk of the cutting edge inadvertently catching on a tributary vein or on the wall of the saphenous vein.
  • the distance should be greater than about 1.3mm in that lesser distances result in inadequate valve lysing, wherein significant valve remnants are left behind following lysing.
  • Previously described valvulotomes of about 2 mm diameter have specified relatively small bulb spacings of less than about 2.5 mm.
  • This bulb spacing distance is measured from the apex of the cutting edge of the cutting bulb closest to the leading bulb, to the point of largest diameter of the leading bulb closest to the cutting bulb, that is, the point at which the diameter of the leading bulb begins to taper and therefore reduce.
  • Figures IA and IB describe side views of valvulotomes of the present invention.
  • Figure 2A describes a side view that defines distance D between the cutting edge and the leading bulb for a valvulotome having a leading bulb with tapered sides.
  • Figure 2B describes a side view that defines distance D between the cutting edge and the leading bulb for a valvulotome having a leading bulb with a rounded distal end.
  • Figure 3 describes a side view showing a method of quantitatively evaluating valve lysis. DETAILED DESCRIPTION OF THE INVENTION
  • Figure IA describes a side view of a valvulotome JO of the present invention having a leading bulb ⁇ _ and a cutting bulb 14 attached to a length of rod or cable 20, typically a guidewire, at the proximal end £4 of the valvulotome 10.
  • the length of rod or cable £0 is most commonly in the form of a guidewire.
  • the two bulbs H and 1 are typically connected by a short length of rod l_ ⁇ , all sharing a common longitudinal axis £6.
  • Leading bulb H has a maximum diameter _ ⁇ and a point J_3 with respect to the longitudinal axis _& which represents the point of closest proximity of maximum diameter 3.. to the apex 16 of the cutting edge or edges of cutting bulb 14.
  • the present invention relates to the discovery that the effectiveness of a valvulotome is related to this distance D between closest point 13 of the maximum diameter 21 of leading bulb 12 and the cutting edge or edges 16 of the cutting bulb 14 closest to the leading bulb 12.
  • Figure IA describes a valvulotome having a cutting edge with multiple apexes 16 from which distance D is measured. Conversely, the cutting edge may be of circular form with only a single, continuous apex 16 as described by Figure IB. Distance D is measured from this single, continuous apex.
  • Figures IA and IB describe valvulotomes JJ) having leading bulbs 12 with straight sides that are parallel to the common longitudinal axis 6 wherein leading bulb end nearest the cutting bulb tapers abruptly from its maximum diameter 1 as it approaches the cutting bulb.
  • Figure 2A describes a valvulotome having a leading bulb with a slight, gradual taper wherein the largest diameter 3.2 occurs at the end opposite the cutting bulb 14.
  • Figure 2B describes a valvulotome having a leading bulb with a rounded end nearest the cutting bulb 14.
  • the distance between the cutting edge of the cutting bulb closest to the leading bulb and the point of the effective largest diameter of the leading bulb closest to the cutting bulb is measured as described by Figures 2A and 2B.
  • the distance, referred to in Figures 2A and 2B as distance D is measured along a first line 41 through the largest diameter 4 of the cutting bulb 14 and parallel to the common longitudinal axis _6.
  • Distance D extends from the cutting edge 1£ of the cutting bulb 14 that is closest to the leading bulb 12, to a point A defined as follows.
  • Point A lies at the Intersection of the first line 4_1 and a second line 43.
  • the second line 43 begins at point B defined by the intersection of the common longitudinal axis ⁇ and a third line 45 through and perpendicular to the common longitudinal axis 26 and through the at least one cutting edge Ji of the cutting bulb 14 closest to the leading bulb 12-
  • the second line 43 extends from point B through a tangent point T on the surface of leading bulb 12, wherein tangent point T is the closest possible tangent point to cutting bulb H.
  • leading bulb _Z is asymmetrical about the common longitudinal axis Z_ ⁇ then it is important that the third line 4j> extends through tangent point T which lies closest to cutting bulb.
  • distance D is preferably between 1.3 and 2.5 mm.
  • two stainless steel valvulotomes were made up using device geometries as shown by Figure IA and described in further detail by PCT Publication Number W093/20764.
  • Leading bulbs 12 and cutting bulbs 14 were provided with female screw threads intended to mate with male screw threads at both ends of connecting rod ⁇ _ ⁇ .
  • Distance D was then adjustable according to the degree of engagement of the screw threads.
  • the two valvulotomes differed in that one was provided with a maximum leading bulb diameter of 2 mm while the other was 3 mm. The maximum diameter of the leading bulb was the same as the cutting bulb for both devices.
  • Both devices were provided with cutting edges having four apexes and four recesses with the entire edge including apexes, recesses and points between being sharpened. It also is anticipated that a distance D between 1.3 and 2.5 mm will also be effective for valvulotomes of diameters larger than 3 mm. Distance D was adjusted to various dimensions for both the 2 mm and 3 mm diameter valvulotomes. For each chosen dimension for distance D, the effectiveness of each valvulotome was tested on cryopreserved human veins at room temperature. The effectiveness was determined by noting the number of times that any cutting edge of the valvulotome caught at any point within the lumen of the vein other than at the attachment point of venous valves. Effectiveness was also measured by opening each vein longitudinally after valve lysis and measuring how much ridge of any lysed valve remained as shown by Figure 3. Cryopreserved human veins were obtained from Northwest Tissue
  • veins had been obtained from donors 65 years of age or younger within 12 hours of death. Cryopreserved human vein has been found to substantially maintain the mechanical and physical properties of living human vein. No veins with a prior history of trauma, varicosity or infection were used. Veins having undistended inside diameters from 1.9 to 3.7 mm and lengths between 25 and 45 cm were used. The number of venous valves per vein ranged from zero to four with two or three being typical.
  • a cryopreserved vein with its proximal end marked was rewarmed in Lactated Ringer's Solution to room temperature and irrigated with the same solution containing 0.5% papaverine by volume. Extraneous tissue was dissected away and all side branches except the most proximal were 1 igated.
  • a second flushing catheter was connected to the remaining, most proximal tributary in order to provide a 100 mm Hg pressure head with the Lactated Ringer's Solution ensuring closure of the venous valves within the vein sample.
  • the proximal end of the vein was clamped off.
  • An inventive valvulotome was introduced to the vein sample distally and passed to the proximal end. The location of venous valves was noted during this procedure. After reaching the proximal end of the vein, the valvulotome was withdrawn by hand back toward the distal end of the vein while paying close attention to the force required to move the valvulotome through the vein and through venous valves as they were encountered by the cutting edge of the valvulotome.
  • valve lysis Following lysis of all valves from each vein, the flow of fluid from the pressure source out of the proximal end of the vein was noted as an indication of valve lysis.
  • a fiberscope was inserted into the vein from the distal end to confirm valve lysis. After removal of the fiberscope, the vein sample was cut open longitudinally for the entire length of the sample to allow inspection of valve lysis. As shown by Figure 3, the degree of valve lysis was evaluated by sliding the pointed tip 52 of a pair of Potts Tenoto y scissors _ ⁇ (Part No. 640280, WECK Surgical Instruments, Largo, FL) along the luminal surface of the longitudinally opened vein J5.
  • the table describes the undistended inside diameter of each vein sample tested, distance D for the valvulotome, the number of valves encountered in the vein sample, the number of valves considered to have been lysed by the valvulotome, the remaining amount of valve ridge as encountered by the scissors tip and the number of times the valvulotome caught at any point within the lumen of the vein other than at valve attachment points (number of hang- ups). For vein sample No. 2, the remaining amount of valve ridge was not recorded.
  • Samples A-C were veins lysed using 3 mm diameter valvulotomes having a bulb separation distance D of 6.0 mm. A total of eight valves were lysed from these three veins. Of these eight valves, two leaflets were left with ridges greater than 1 mm, and three hang-ups occurred, for a total of five failure incidents or 62.5 percent for eight valves.
  • Samples D-H were veins lysed using 3 mm diameter valvulotomes of the present invention having bulb separation distances of 1.3 to 2.5 mm. These valvulotomes were used to lyse a total of eleven valves from the five veins. One valve leaflet was left with a ridge dimension of greater than 1.0 mm and no hang-ups occurred, for a failure rate of 9 percent for the eleven valves from this group. Samples I-K were veins lysed using 3 mm diameter valvulotomes having a bulb separation distance D of 1.0 mm or less. A total of five valves were lysed with four valve leaflets having remaining ridges of greater than 1.0 mm and with no hang-ups, for a failure incidence of 80 percent.
  • the 3 mm valvulotomes having bulb separations in the inventive range were safer and more effective than were units with bulb separations outside of the inventive range.
  • the data for the 3 mm diameter valvulotomes were consistent with the 2 mm diameter valvulotome data, indicating that the preferred spacing of the valvulotome bulbs is independent of device diameter. The consistency of the data also indicate that similar results could be expected of valvulotomes of about 2.5 mm diameter.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Ces valvulotomes, d'un diamètre de 2,5 mm ou plus, présentent un bulbe de coupe, comprenant au moins un bord de coupe, et un bulbe frontal de ces deux bulbes étant reliés par leur axe longitudinal commun et séparés par une distance de 1,3 à 2,5 mm.
PCT/US1996/013836 1995-11-01 1996-08-28 Valvulotomes WO1997016125A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU69041/96A AU6904196A (en) 1995-11-01 1996-08-28 A valvulotome

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US55159195A 1995-11-01 1995-11-01
US08/551,591 1995-11-01

Publications (1)

Publication Number Publication Date
WO1997016125A1 true WO1997016125A1 (fr) 1997-05-09

Family

ID=24201889

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/013836 WO1997016125A1 (fr) 1995-11-01 1996-08-28 Valvulotomes

Country Status (2)

Country Link
AU (1) AU6904196A (fr)
WO (1) WO1997016125A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7717930B2 (en) 2004-02-27 2010-05-18 Cook Incorporated Valvulotome with a cutting edge
ITTO20090564A1 (it) * 2009-07-24 2011-01-25 Zeppi Augusto Dispositivo per il trattamento di malformazioni valvolari in vasi venosi periferici, quali ad esempio le vene giugulari interne, e relativo corredo
US8398663B2 (en) 2004-02-27 2013-03-19 Cook Medical Technologies Llc Valvulotome device and method
US8460331B2 (en) 1998-08-12 2013-06-11 Maquet Cardiovascular, Llc Tissue dissector apparatus and method
WO2015118603A1 (fr) * 2014-02-04 2015-08-13 隆俊 古屋 Lame coupante pour valvule veineuse et son procédé de fabrication
US9782191B2 (en) 2014-01-21 2017-10-10 Cook Medical Technologies Llc Cutting devices and methods
US9872693B2 (en) 2014-02-04 2018-01-23 Takatoshi Furuya Venous valve incising blades, manufacturing method of the same and artery revascularization treatment using the same
US10299770B2 (en) 2006-06-01 2019-05-28 Maquet Cardiovascular Llc Endoscopic vessel harvesting system components
US10507012B2 (en) 2000-11-17 2019-12-17 Maquet Cardiovascular Llc Vein harvesting system and method

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4019147A1 (de) * 1989-06-14 1991-02-07 Nobles Lai Engineering Inc Vorrichtung zum durchtrennen von venenklappen in situ und deren verwendung
US5139506A (en) * 1991-03-22 1992-08-18 Pilling Co. Valvulotome
WO1993020764A1 (fr) * 1992-04-09 1993-10-28 Uresil Corporation Sectionneur ameliore de valvules de sinus veineux
WO1995028888A1 (fr) * 1994-04-25 1995-11-02 Gore & Ass Valvulotome

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4019147A1 (de) * 1989-06-14 1991-02-07 Nobles Lai Engineering Inc Vorrichtung zum durchtrennen von venenklappen in situ und deren verwendung
US5139506A (en) * 1991-03-22 1992-08-18 Pilling Co. Valvulotome
WO1993020764A1 (fr) * 1992-04-09 1993-10-28 Uresil Corporation Sectionneur ameliore de valvules de sinus veineux
WO1995028888A1 (fr) * 1994-04-25 1995-11-02 Gore & Ass Valvulotome

Cited By (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9730782B2 (en) 1998-08-12 2017-08-15 Maquet Cardiovascular Llc Vessel harvester
US8460331B2 (en) 1998-08-12 2013-06-11 Maquet Cardiovascular, Llc Tissue dissector apparatus and method
US9700398B2 (en) 1998-08-12 2017-07-11 Maquet Cardiovascular Llc Vessel harvester
US8986335B2 (en) 1998-08-12 2015-03-24 Maquet Cardiovascular Llc Tissue dissector apparatus and method
US10507012B2 (en) 2000-11-17 2019-12-17 Maquet Cardiovascular Llc Vein harvesting system and method
US8398663B2 (en) 2004-02-27 2013-03-19 Cook Medical Technologies Llc Valvulotome device and method
US7717930B2 (en) 2004-02-27 2010-05-18 Cook Incorporated Valvulotome with a cutting edge
US11141055B2 (en) 2006-06-01 2021-10-12 Maquet Cardiovascular Llc Endoscopic vessel harvesting system components
US11134835B2 (en) 2006-06-01 2021-10-05 Maquet Cardiovascular Llc Endoscopic vessel harvesting system components
US10299770B2 (en) 2006-06-01 2019-05-28 Maquet Cardiovascular Llc Endoscopic vessel harvesting system components
WO2011010296A1 (fr) * 2009-07-24 2011-01-27 London Equitable Limited In Its Capacity As Trustee Of The Think Tank Trust Dispositif de traitement de malformations valvulaires dans des veines périphériques, telles que les veines jugulaires internes, et trousse associée
ITTO20090564A1 (it) * 2009-07-24 2011-01-25 Zeppi Augusto Dispositivo per il trattamento di malformazioni valvolari in vasi venosi periferici, quali ad esempio le vene giugulari interne, e relativo corredo
US10918408B2 (en) 2014-01-21 2021-02-16 Cook Medical Technologies Llc Cutting devices and methods
US9782191B2 (en) 2014-01-21 2017-10-10 Cook Medical Technologies Llc Cutting devices and methods
DE102015101418B4 (de) 2014-02-04 2018-05-30 Takatoshi FURUYA Venenklappenschneidvorrichtung sowie Verfahren zu deren Herstellung
US10799259B2 (en) 2014-02-04 2020-10-13 Takatoshi FURUYA Venous valve incising blades, manufacturing method of the same and artery revascularization treatment using the same
US9872693B2 (en) 2014-02-04 2018-01-23 Takatoshi Furuya Venous valve incising blades, manufacturing method of the same and artery revascularization treatment using the same
WO2015118603A1 (fr) * 2014-02-04 2015-08-13 隆俊 古屋 Lame coupante pour valvule veineuse et son procédé de fabrication

Also Published As

Publication number Publication date
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