EP0565648A1 - Catheter a ballon a prise de dimensions - Google Patents

Catheter a ballon a prise de dimensions

Info

Publication number
EP0565648A1
EP0565648A1 EP92912140A EP92912140A EP0565648A1 EP 0565648 A1 EP0565648 A1 EP 0565648A1 EP 92912140 A EP92912140 A EP 92912140A EP 92912140 A EP92912140 A EP 92912140A EP 0565648 A1 EP0565648 A1 EP 0565648A1
Authority
EP
European Patent Office
Prior art keywords
balloon
opening
catheter
balloon catheter
reference marker
Prior art date
Legal status (The legal status 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 status listed.)
Withdrawn
Application number
EP92912140A
Other languages
German (de)
English (en)
Other versions
EP0565648A4 (en
Inventor
James E. Lock
Randall W. Davis
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CR Bard Inc
Original Assignee
CR Bard 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 CR Bard Inc filed Critical CR Bard Inc
Publication of EP0565648A1 publication Critical patent/EP0565648A1/fr
Publication of EP0565648A4 publication Critical patent/EP0565648A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/107—Measuring physical dimensions, e.g. size of the entire body or parts thereof
    • A61B5/1076—Measuring physical dimensions, e.g. size of the entire body or parts thereof for measuring dimensions inside body cavities, e.g. using catheters

Definitions

  • This invention relates to a balloon catheter constructed and arranged for sizing openings in body cavities.
  • Balloon catheters are well-known and have been put to various uses in vivo, including occlusion and angioplasty. More recently, balloon catheters constructed
  • a septal defect is an abnormal hole in the wall separating the left and right sides of the heart, either between the two atrial or the two ventricle chambers. The defect allows deoxygenated
  • the invention provides a catheter for sizing an opening in a body cavity.
  • the catheter includes a compliant balloon attached to the distal end of the catheter and a reference marker located on the catheter adjacent to the balloon.
  • the balloon preferably is constructed and arranged such that it is capable upon c inflation of conforming to the opening without substantially distorting the opening. The ability to conform to the opening without distorting it permits an accurate visual image of the opening to be detected (e.g., radiographically) .
  • the reference marker provides a scale i for determining the error resulting from the detection equipment (e.g. , error caused by magnification of a radiographic image) .
  • the reference marker preferably is a pair of highly radiopaque bands space at a preselected distance from one another.
  • Methods for sizing an opening ⁇ i c in a body cavity also are provided.
  • the balloon catheter of the invention is placed such that the balloon spans an opening, the balloon containing a fluid that permits detection of a represented size of the opening.
  • the represented size of the opening then is compared to the ?n reference markers located on the catheter adjacent to the balloon.
  • the balloon first is positioned adjacent the opening and is inflated to a diameter larger than the diameter of the opening. The balloon then is moved toward and into the opening until 5 the balloon spans and is centered within the opening.
  • the balloon is provided with a tapered neck, preferably a tapered proximal neck.
  • the methods and devices of the invention permit accurate determination of the sizes of body cavity Q openings, which determinations may be made quickly and easily during in vivo medical procedures.
  • FIG. 1 depicts a sizing balloon catheter 5 according to the invention.
  • FIG. 2 is an enlarged, cross-sectional view of the balloon of FIG. 1.
  • FIG. 3 is an enlarged, cross-sectional view of the catheter of FIG. 1 taken along lines 3-3.
  • FIG. 4 shows a balloon catheter of the invention with the balloon positioned distally of a defect, but uninflated.
  • FIG. 5 is the same as FIG. 4, except that the balloon is inflated.
  • FIG. 6 shows a balloon catheter of the invention with the balloon positioned across a defect and inflated.
  • the invention relates to methods and devices for determining in vivo the size of a body cavity opening.
  • body cavity opening it is meant a narrowed region within a body cavity, such as, a septal defect (e.g., atrial septal defect (ASD) or ventricular septal defect (VSD) ) .
  • a septal defect e.g., atrial septal defect (ASD) or ventricular septal defect (VSD)
  • ASD atrial septal defect
  • VSD ventricular septal defect
  • the balloon catheter of the invention is useful in connection with sizing openings in the vascular system.
  • the balloon catheter may also be useful in connection with sizing openings in other body cavities, such as urological, esophageal or gastroenterological cavities.
  • FIG. 1 A preferred embodiment of a cardiovascular sizing balloon catheter is shown in Fig. 1. This device is particularly useful for sizing ASD, VSD and other congenital defects.
  • the balloon catheter 10 is a three-lumen polyurethane catheter 12 with a latex balloon 14 attached to its distal end. Just proximal to the latex balloon 14 are a pair of radiopaque reference markers 16. At the proximal end of the device are a balloon leg 18 with a stop cock 20 for receiving a fluid to inflate the balloon and a guide wire leg 22 for receiving a guide wire (not shown) to guide the catheter to the desired location in the body.
  • the balloon according to the invention is complaint, that is, capable of elastic deformation, preferably at pressures of about 1-2 atmospheres.
  • the balloon is constructed and arranged so that it is capable of conforming upon inflation to a septal defect without substantially distorting the defect.
  • substantially distorting it is meant that only a minimal amount of distortion occurs.
  • the balloon is constructed and arranged such that it will conform to that part of the defect which is strong enough to provide a • jQ stable platform for an umbrella closure device. In this instance, some slight distortion of the septal defect would occur, and such slight distortion is considered to be embraced within the concept of a balloon that, upon inflation, does not substantially distort the septal • j c defect.
  • the balloon when inflated is lemon-shaped; the balloon when inflated has a gradual taper at least at its proximal end, is somewhat rounded through its middle and may be tapered at its distal end as well.
  • gradual taper it is meant that the balloon has a shape that it is capable of centering of the balloon as it is drawn into the opening, as will be described more fully below in connection with the methods of the invention.
  • a balloon having the desired shape when inflated may be formed by a coagulant dipping process using a mandrel.
  • the mandrel has the approximate inside shape of the balloon in its uninflated, noncollapsed state (Fig. 2) , accounting for shrinkage of the balloon after vulcanization.
  • the preferred balloon forming process Q involves vertically dipping the mandrel into a salt solution, withdrawing the mandrel from the salt solution, and allowing the solvent to evaporate to produce a semi- dry salt film on the mandrel.
  • the mandrel then is vertically lowered into a latex compound bath, held in the bath and withdrawn. The latex deposit is then vulcanized.
  • the speed of the dipping and the length of time that the mandrel is held in the baths will depend upon factors well known to those of ordinary skill in the art, such as for example the viscosity of the baths and chemical stability of the latex, keeping in mind the ultimate latex balloon c thickness desired. It should be understood that other latex forming methods well known to those of ordinary skill in the art can be employed to produce a latex balloon having the desired shape.
  • the balloon has a proximal neck 24 of increasing diameter in a distal direction, a mid-portion 26 of uniform diameter, and a distal neck 28 of decreasing diameter in a distal direction. These segments are flanked by a proximal portion 30 and distal portion 32.
  • the distal portion 32 is of uniform diameter and has an I.D. of about 0.074 inches, and an O.D. of about 0.084 inches, defining a wall thickness of about 0.005 inches.
  • the junction 34 of the distal portion 32 and the distal neck 28 has a radius of 0.06 inches.
  • the distal neck 28 extends from the distal portion 32 at an angle of about . 30°.
  • the mid portion 26 of the latex balloon 14 has an I.D.
  • the proximal neck 24 tapers gradually from the mid portion 26 to the proximal portion 30 at a radius of about 0.20 inches.
  • the proximal portion 30 has an I.D. of about 0.085 inches and an O.D. of about 0.093 inches, defining a wall thickness of about 0.004 inches.
  • the proximal neck 24 meets the proximal portion 30 at proximal junction 36. The distance from the distal junction 34 to the proximal junction 36 is about 0.550 inches.
  • the preferred balloon is made of latex and has a modulus at 500% elongation of about 390 psi, a tensile strength of about 5700 psi and an ultimate elongation at break of about 950%. It is preferred that the minimum -. c modulus at 500% elongation be at least 375 psi, the minimum tensile strength be at least 4500 psi and the minimum ultimate elongation at break be at least 750%.
  • the balloon, in its uninflated and collapsed state is capable of being passed through a 10F hole, but is unable to pass through an 8F hole.
  • the balloon c preferably is capable of sustaining 20CC inflation of fluid (e.g., water), and the inflated balloon should be free from windows (thin or weak spots) or other visual defects.
  • fluid e.g., water
  • the openings to be sized by such balloons typically are between 3mm and 30mm. It will be understood, of course, that openings larger and smaller would be sized preferably using balloons having different overall dimensions. The devices according to the invention, however, typically would be used to size openings of between about 1 mm and 25 mm.
  • the reference marker is a detectable marker of preselected length which may be used as a comparative value for estimating or even measuring the size of an opening.
  • the reference marker should be positioned close enough to the balloon so that the marker may be visualized along with the balloon on the same screen. To permit simultaneous viewing of the balloon and marker on typical radiographic equipment, the markers should be within 5 centimeters of the balloon and preferably within about 2 centimeters of the balloon.
  • the marker can be highly radiopaque, including those fabricated of gold, platinum, palladium and titanium.
  • the preferred reference marker is a pair of thin, highly radiopaque bands 16, of preselected width and spaced apart from one another at a preselected distance (one cm) .
  • Each reference marker 16 is a tantalum band having a width of about 0.040 inches, an inner diameter of about 0.084 inches and outer diameter of about 0.090 inches, thereby defining a thickness of about 0.003 inches.
  • the catheter of the preferred embodiment is a three-lumen, polyurethane catheter 12 shown in cross- 5 section in Fig. 3.
  • the catheter 12 has an outer wall 38 that is substantially cylindrical and three web walls 40 that divide the catheter into three lumens.
  • Two smaller lumens 42 are sized such that a circle 44 having a diameter of about 0.021 inches can fit within each of the XO lumens. These smaller lumens 42 are for inflating and deflating the balloon.
  • a larger lumen 46 is sized such that a circle 48 having a diameter of about 0.041 inches can fit within it. This larger lumen 46 is for receiving a guide-wire.
  • the thickness of the outer wall 38 and web X wall 40 is a minimum of about 0.006 inches, and the O.D.
  • the catheter is about 0.090 inches.
  • the catheter has a roundness of 0.086 inches minimum on any axis and 0.093 inches maximum on any axis.
  • the catheter was fabricated of polyurethane using conventional procedures.
  • the o catheter has a tensile strength at break of about
  • the tantalum bands are placed at a desired location on the shaft of the three-lumen polyurethane catheter. This is accomplished 0 by slightly stretching the catheter, not beyond the elastic limit of the material, and sliding the bands into place. Subsequent release of the catheter from the stretching allows the catheter to return to its original shape and dimension, thereby holding the tantalum bands in 5 place. Mandrels are used to maintain lumen patency.
  • openings or eyes communicating with the smaller lumens 42 are made through the outer wall 38 of the catheter 12 at the distal tip area to permit inflation and deflation of the balloon once the balloon is attached to the catheter.
  • These eyes were separated (as opposed to 5 skiving into both inflation lumens at the same location) , so as to decrease the likelihood of the latex balloon occluding the eyes during deflation. In other words, if the balloon were to obstruct the proximal eye during deflation, the distal eye would still be patent and - n available to complete the deflation process.
  • the distal tip area of the catheter is shrunk down to provide a lower-profile distal-tip area.
  • This may be accomplished using a silicone tubing sleeve.
  • the silicone tubing first is swelled in freon, and then is - c allowed to shrink upon the tip of the polyurethane catheter via air drying (freon vaporizes out) .
  • the tip area then is heated, and in particular the balloon lumens are heated up to the tip.
  • the silicone tubing next is removed by re-swelling the tubing with freon and sliding p ⁇ it off.
  • An appropriate sized mandrel maintains the larger lumen 46 patency.
  • the tip is trimmed to length and then is rounded off using abrasive stone or paper.
  • the balloon is attached to the distal end of the catheter by flipping or rolling the ends of the proximal 2 5 portion 30 and distal portion 34 toward one another to expose their inside surfaces.
  • a bead of adhesive is placed on the shaft at appropriate bond location. The ends are rolled or flipped back such that the inside surfaces of the proximal and distal end portions are in - solo contact with adhesive and are attached to the outside surface of the catheter.
  • the reference markers are coated with a biocompatible polyurethane composition to provide a smoother transition between the edges of the reference 5 markers and the catheter.
  • the edges of the balloon are also coated to provide a smoother transition.
  • a guidewire 50 first is positioned across a septal defect 52.
  • the balloon catheter 10 of the invention then 5 is advanced over the guidewire until the latex balloon 14 is positioned distal to the septal defect 52.
  • the balloon is inflated to a volume slightly larger than the defect, preferably using a 4:1 ratio of contrast medium to normal saline.
  • the recommended maximum balloon inflation is
  • n about 15cc.
  • the balloon when inflated has a gradual taper along its proximal neck.
  • This substantially funnel-shaped neck serves dual purposes; it acts to center the catheter (and therefore the balloon) within the
  • the balloon catheter 10 then is slowly withdrawn over the guidewire into the septal defect with the balloon inflated, until the balloon is positioned approximately centrally of the septal defect 52. If resistance is encountered manually y _- or is visualized, the balloon may be partially deflated. The balloon, when positioned across the defect in this manner, will conform to the shape of the septal defect, thereby forming the balloon into the shape of an hourglass.
  • the central portion of the hourglass shape or ⁇ "waist" of the balloon then represents the size of the opening defined by the septal defect.
  • the size of the opening then may be estimated or even measured directly on the screen of the radiographic equipment. 5

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Physics & Mathematics (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

Produits et procédés permettant de prendre les dimensions d'ouvertures se trouvant dans des cavités du corps. Les produits sont des cathéters dotés de ballons souples fixés à leurs extrémités distales, et de marqueurs de référence situés sur le cathéter à proximité des ballons. Le dispositif préféré est un ballon de prise de dimensions cardiovasculaires utilisé pour prendre les dimensions de défauts septaux, et il comprend un ballon en latex (14) présentant une partie conique proximale (24) ainsi qu'une paire de bandes radiopaques espacées (16) situées à proximité immédiate du ballon.
EP19920912140 1991-05-15 1992-05-12 Sizing balloon catheter Withdrawn EP0565648A4 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US70058991A 1991-05-15 1991-05-15
US700589 1991-05-15

Publications (2)

Publication Number Publication Date
EP0565648A1 true EP0565648A1 (fr) 1993-10-20
EP0565648A4 EP0565648A4 (en) 1994-07-06

Family

ID=24814097

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19920912140 Withdrawn EP0565648A4 (en) 1991-05-15 1992-05-12 Sizing balloon catheter

Country Status (2)

Country Link
EP (1) EP0565648A4 (fr)
WO (1) WO1992020280A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5885228A (en) * 1996-05-08 1999-03-23 Heartport, Inc. Valve sizer and method of use
EP0897285A4 (fr) * 1996-05-10 2000-03-08 Cardiovascular Concepts Inc Catheter et procede pour mesurer le diametre d'une lesion
US6241678B1 (en) * 1998-08-21 2001-06-05 Aga Medical Corporation Sizing catheter for measuring septal defects
US6210338B1 (en) * 1998-08-21 2001-04-03 Aga Medical Corp. Sizing catheter for measuring cardiovascular structures
US6533799B1 (en) 1999-04-27 2003-03-18 Ams Research Corporation Cavity measurement device and method of assembly
US7654264B2 (en) 2006-07-18 2010-02-02 Nellcor Puritan Bennett Llc Medical tube including an inflatable cuff having a notched collar
CN120021978B (zh) * 2025-04-24 2025-07-04 安忻(成都)医疗科技发展有限责任公司 一种宫腔测距装置

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3978863A (en) * 1974-06-06 1976-09-07 Bruce E. Fettel Expanding tip embolectomy catheter with indicator balloon
US4630609A (en) * 1981-05-14 1986-12-23 Thomas J. Fogarty Dilatation catheter method and apparatus
US4545390A (en) * 1982-09-22 1985-10-08 C. R. Bard, Inc. Steerable guide wire for balloon dilatation procedure
JPS62261371A (ja) * 1986-05-08 1987-11-13 テルモ株式会社 カテ−テル
US4836204A (en) * 1987-07-06 1989-06-06 Landymore Roderick W Method for effecting closure of a perforation in the septum of the heart
US5058603A (en) * 1988-08-09 1991-10-22 Asahi Kogaku Kogyo K.K. Length-measuring device and reference color display device for color tone adjustment for use in combination with endoscope
US5108369A (en) * 1990-03-15 1992-04-28 Diagnostic Devices Group, Limited Dual-diameter multifunction catheter

Also Published As

Publication number Publication date
WO1992020280A1 (fr) 1992-11-26
EP0565648A4 (en) 1994-07-06

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