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WO2003049794A1 - Appareil et procede permettant de determiner la longueur et la taille de stents a deployer dans des vaisseaux sanguins stenoses et d'effectuer le test de passage pour le port direct de stents - Google Patents

Appareil et procede permettant de determiner la longueur et la taille de stents a deployer dans des vaisseaux sanguins stenoses et d'effectuer le test de passage pour le port direct de stents Download PDF

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Publication number
WO2003049794A1
WO2003049794A1 PCT/SG2002/000285 SG0200285W WO03049794A1 WO 2003049794 A1 WO2003049794 A1 WO 2003049794A1 SG 0200285 W SG0200285 W SG 0200285W WO 03049794 A1 WO03049794 A1 WO 03049794A1
Authority
WO
WIPO (PCT)
Prior art keywords
marker
markers
distal end
catheter
gauging
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.)
Ceased
Application number
PCT/SG2002/000285
Other languages
English (en)
Inventor
Siam Soon Philip Koh
Ye Ping
John E. Shulze
Douglas Robert Savage
Dan Wang
Kok Wui Guan
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.)
Biosensors International Pte Ltd
Original Assignee
Biosensors International Pte Ltd
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 Biosensors International Pte Ltd filed Critical Biosensors International Pte Ltd
Priority to AU2002366628A priority Critical patent/AU2002366628A1/en
Publication of WO2003049794A1 publication Critical patent/WO2003049794A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
    • A61B1/00064—Constructional details of the endoscope body
    • A61B1/00071—Insertion part of the endoscope body
    • A61B1/0008—Insertion part of the endoscope body characterised by distal tip features
    • A61B1/00082—Balloons
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/06—Measuring instruments not otherwise provided for
    • A61B2090/061—Measuring instruments not otherwise provided for for measuring dimensions, e.g. length
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/37—Surgical systems with images on a monitor during operation
    • A61B2090/376—Surgical systems with images on a monitor during operation using X-rays, e.g. fluoroscopy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters

Definitions

  • the present invention relates in general to the field of catheters for use in non-surgical treatment of stenotic lesions in coronary artery. More particularly, the present invention relates to an apparatus and method for measuring and gauging the length and size of the intra-coronary stents to be used.
  • Catheters are well known and commonly used in the medical treatment of disorders. Catheters allow for access into organs, both solid and hollow, luminal/ductal passages and vascular structures enabling the delivery of diagnostic or therapeutic agents besides the drainage of accumulated bodily fluids or debris.
  • a wide range of catheters have been invented to access the arterial vasculature, in particular the coronary vessels, to treat stenotic artheromatous plaques.
  • Percutaneous Transluminal Coronary Angioplasty is now a widely used procedure. It involves the use of a catheter with a preformed "sausage- shaped" inflatable balloon at its distal end (commonly referred to as a balloon catheter) riding on a slender steerable guide wire to be delivered to the stenotic lesion site. The balloon is then inflated to re-open or dilate the artery so as to re-establish flow of blood. This procedure is sometimes referred to as "balloon angioplasty". The inflation of this balloon through a pressure gauge at the proximal end of the balloon catheter stretches and remodels the stenotic lesion site. In effect achieving a wider lumen in the artery that approximates its original luminal diameter. This method of balloon angioplasty has its attendant problems/complications dissection and restenosis.
  • Stents are metallic scaffoldings of varied designs that are implanted at stenotic lesion sites in arteries to achieve a more predictable and controlled result following balloon angioplasty.
  • Stents are commonly made of surgical stainless steel, "wire- meshed” like or netted in appearance that are commonly crimped onto the deflated balloon and delivered to the desired site for deployment. The balloon is then deflated and withdrawn from the artery. The stent remains in place, serving as a scaffolding for the newly opened or dilated artery.
  • balloon expandable stents are self-expanding stents, delivered via plain catheters but retained in position on it by a retaining outer sheath. Pulling back of such a sheath allows the deployment of a self expanding stent.
  • the use of stents have eliminated many of the complications associated with balloon angioplasty, and the additional strength of the stent keeps the artery open whilst in the healing process.
  • the gauging catheter mentioned here has an added feature that specifically addresses the issue of predicting the deliverability of higher profile stent delivery system, besides facilitating in the same gauging maneuver the subsequent passage of the stent delivery system.
  • the present invention provides a novel intracoronary lesion gauging catheter for accurately assisting in determining the length and size of a suitable stent to be deployed.
  • the distal end of the catheter is furnished with at least 4 radio-opaque markings or markers in a unique and novel arrangement which makes for ease of determination of length of the suitable stent to be used.
  • the markers also aid in the determination of the size or diameter of the stent.
  • the markings are arranged in the following manner: a first marker at distal end of catheter; a second marker positioned 5 m m proximally from first marker; a third marker positioned 3 mm proximally from second marker, and a fourth marker positioned 10 mm proximally from third marker.
  • the present invention also serves to function as a test of passage for direct stenting.
  • the same distal end of the gauging catheter is bulleted to simulate the profile of a stent and balloon assembly for this purpose.
  • Fig. 1 is a partial cut-away plan view of a gauging catheter according to one form of the present invention.
  • Fig. 2 shows an enlarged view of the distal end of the gauging catheter according to the present invention.
  • Fig. 3 shows a generic illustration of a typical marker according to one form of the present invention.
  • Fig. 4 shows a partial cut-away plan view of an Intracoronray Lesion Gauging Catheter according to the preferred form of the invention.
  • a gauging catheter 100 according to one form of the present invention comprises of a hub 102 at the proximal end, a flexible catheter tube 104, and a tip 106 at the distal end. At the distal end of the flexible catheter tube 104 are disposed a series of markers 110a to 11 Oe. A bulleted structure 108 is provided at the distal end to simulate the profile of a stent and balloon assembly.
  • the markers 110a to 110e are radio-opaque to allow viewing of the markers through fluoroscopy or similar technology.
  • the markers have been positioned in a unique and novel arrangement to allow for ease of matching of a suitable stent length to a lesion of a stenotic blood vessel.
  • the most popular and readily available stents are in the lengths of : 8mm, 13mm, 15mm, 18mm, 23mm, 25mm, 28mm, 33mm and 38mm.
  • the present invention allows the surgeon to easily match the markings on the gauging catheter to the lesion in the blood vessel.
  • the markers 110 are each 1mm in width with a distal edge 112 and a proximal edge 114.
  • the distance from the proximal edge 114 of the first marker 110a to the proximal edge 114 of the second marker 110b is 5 mm.
  • the distance from the proximal edge 114 of the second marker 110b to the proximal edge 114 of the third marker 110c is 3mm.
  • the distance from the proximal edge 114 of the third marker 110c to the proximal edge of the fourth marker 110d is 10mm, likewise between the fourth marker 110d to the fifth marker 110e.
  • the markers 110 are all 1mm in width and can be made of any radio-opaque materials. As such, the same lengths of 5mm, 3mm and 10 mm are achieved when measuring from the distal edge 112 of one marker to the distal edge 112 of the next marker 110.
  • the gauging catheter 100 is inserted into the diseased blood vessel and the distal end is introduced into the location of the lesion.
  • the surgeon can then match the markers 110 on the gauging catheter to the length of the lesion and determine the most suitable length of stent to be used.
  • the surgeon is in effect not so much taking a measurement of the lesion as to matching the best fit length of stent to be used.
  • the distortions of the image does not severely impair the surgeon's ability to match and compare the markers 110 to the lesion. This method is advantageously more intuitive and simpler to put into practice then taking an actual measurement of the lesion.
  • the markers 110 are all 1mm in length and provides a more accurate reference when estimating the size or diameter of stent required as compared to using the catheter diameter.
  • the invention also serves to simulate the profile of a crimped stent and balloon assembly and to function as a test of passage for direct stenting.
  • the bulleted structure 108 has a diameter of 0.049 inch or about 1.24 mm and a length of 18 mm. These dimensions are slightly larger than the typical crimped stent and balloon assembly. These dimensions have been deemed to produce the best results in terms of tractability and maneuverability of the bulleted structure in the blood vessel.
  • the length of the bulleted structure 108 also encompasses the first marker 110a to the fourth marker 110d.
  • the surgeon would introduce the gauging catheter 100 into the diseased blood vessel and attempt to push the bulleted structure 108 at the distal end of the catheter into the artery across the lesion. If successful, this would indicate to the surgeon that direct stenting is possible. Whereas inability to push the bulleted structure in would mean that a first balloon angioplasty is required before deployment of the stent.
  • the present invention thus advantageously allows the test of passage of a stent and balloon assembly for direct stenting.
  • the bulleted structure 108 could be made of a variety of materials and would not only provide the physical aspects in terms of dimensions, but also the flexibility and feel of the simulated stent and balloon assembly.
  • the present bulleted structure 108 is made of a combination of different grades of stiffness of a thermoplastic polyether which is commonly known as PEBAX.
  • PEBAX is also commonly used in the manufacture of catheters.
  • the gauging catheter 100 uses readily available materials for its construction and is typically simple and easily manufactured at a low cost.
  • the bulleted structure 108 should not be mistaken to be simply a slightly larger deflated balloon or a slightly inflated balloon of a balloon catheter.
  • a preferred example of the invention would be a Intracoronary Lesion Gauging Catheter.
  • the Intracoronary Lesion Gauging Catheter will specifically be used for treatment of a stenotic coronary artery.
  • Its design would be one based on the rapid exchange system.
  • the design comprises of a distal tubing 213 (usually made of nylon or PEBAX material) with a soft and flexible distal tip 206.
  • Mounted on the distal tubing are the markers 210a to 21 Oe. According to the invention the markers 210 are arranged in a "5-3-10-10" arrangement as described.
  • the distal tubing 213 is about 20 cm in length from the distal tip 206 and ends proximally in a guide wire hole 216.
  • the guide wire hole 216 and opening at distal tip 206 forms a channel for guide wire passage.
  • the distal tubing 213 is reinforced by a stylet 214 for a distance of 16 cm from the distal end of the hypotube.
  • the stylet 214 is typically a stainless steel wire. It maintains the shape and rigidity of the distal tubing 213 when inserting into the stenotic coronary artery.
  • a bulleted structure 208 encompasses the distal tubing 213 from the first marker 210a to the fourth marker 21 Od.
  • the bulleted structure 208 is about 1.24 mm in diameter and about 18 mm in length.
  • the bulleted structure 208 is hollow and has a perfusion hole 207 at its distal end.
  • a sleeve 212 continues from the bulleted structure 208 over the distal tubing 213 and is bonded to the catheter shaft 204.
  • the stylet 214 is also welded to the catheter shaft 204.
  • the catheter shaft 204 is made of a stainless steel hypotube. It is designed for optimum tractability during catheter insertion.
  • the hypotube is coated with a thin layer of PTFE materal.
  • the catheter shaft 204 is provided with a first marker 205a at distance of 90 cm from the distal tip 206.
  • a second marker 205b at a distance of 100 cm from the distal tip 206.
  • the proximal end of the catheter shaft 204 is bonded to a hub 202.
  • the hub 202 is provided with a female luer fitting for engaging with other instrument or medical devices.
  • the hub 202, catheter shaft 204, sleeve 212 and perfusion hole 207 at the distal end of the bulleted structure 208 form a channel for infusion of a contrast medium.
  • catheters are generally well known in the art, and the invention can be used in the many forms and types of catheters available. Some of the more common catheters are : over the wire systems, rapid exchange system or fixed wire systems. They may not necessarily be made up of only one flexible catheter tube, and may consist of a plurality of flexible tubes or lumens each serving a separate function. It would be apparent to one skilled in the art that the present invention may be modified or used in or with other types of catheter systems without departing from the scope of the invention.

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  • Health & Medical Sciences (AREA)
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  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Dentistry (AREA)
  • Transplantation (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Optics & Photonics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne un nouveau calibrage permettant de contribuer, avec précision, à la détermination de la longueur et de la taille d'un stent approprié qui doit être déployé. L'extrémité distale du cathéter comporte une série de marquages opaques aux rayons X dans un agencement unique et nouveau facilitant la détermination de la longueur du stent à utiliser. Les marquages contribuent également à la détermination de la taille du stent. L'invention est également utilisée pour la mise en oeuvre du test de passage en vue du port direct de stents. L'extrémité distale du cathéter de calibrage est de forme générale arrondie afin de simuler le profil d'un ensemble à stent et ballonnet pour un tel usage.
PCT/SG2002/000285 2001-12-12 2002-12-09 Appareil et procede permettant de determiner la longueur et la taille de stents a deployer dans des vaisseaux sanguins stenoses et d'effectuer le test de passage pour le port direct de stents Ceased WO2003049794A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002366628A AU2002366628A1 (en) 2001-12-12 2002-12-09 An apparatus and method for determining the length and size of stents to be deployed in a stenotic blood vessel and for test of passage for direct stenting

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SG200107782 2001-12-12
SG200107782-5 2001-12-12

Publications (1)

Publication Number Publication Date
WO2003049794A1 true WO2003049794A1 (fr) 2003-06-19

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PCT/SG2002/000285 Ceased WO2003049794A1 (fr) 2001-12-12 2002-12-09 Appareil et procede permettant de determiner la longueur et la taille de stents a deployer dans des vaisseaux sanguins stenoses et d'effectuer le test de passage pour le port direct de stents

Country Status (2)

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AU (1) AU2002366628A1 (fr)
WO (1) WO2003049794A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1700566A1 (fr) * 2005-03-10 2006-09-13 General Electric Company Système, méthode et formule pour le calcul de la mesure d'un stent
WO2010150145A1 (fr) 2009-06-23 2010-12-29 Koninklijke Philips Electronics N.V. Support de dimensionnement de dispositif lors d'interventions
US10543117B2 (en) 2015-02-20 2020-01-28 Cook Medical Technologies Llc Duet stent deployment system and method of performing a transjugular intrahepatic portosystemic shunting procedure using same
EP4445835A3 (fr) * 2017-02-24 2025-01-22 HeartFlow, Inc. Systèmes et procédés d'identification de caractéristiques de flux sanguin anatomiquement pertinentes chez un patient

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5479938A (en) * 1994-02-07 1996-01-02 Cordis Corporation Lumen diameter reference guidewire
WO1996039077A1 (fr) * 1995-06-06 1996-12-12 Corvita Corporation Appareil de mesure endovasculaire, moyen de chargement et de deploiement
JP2001070439A (ja) * 1999-09-07 2001-03-21 Kiisumakku:Kk 尿道ステント留置用ゲージ

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5479938A (en) * 1994-02-07 1996-01-02 Cordis Corporation Lumen diameter reference guidewire
WO1996039077A1 (fr) * 1995-06-06 1996-12-12 Corvita Corporation Appareil de mesure endovasculaire, moyen de chargement et de deploiement
JP2001070439A (ja) * 1999-09-07 2001-03-21 Kiisumakku:Kk 尿道ステント留置用ゲージ

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1700566A1 (fr) * 2005-03-10 2006-09-13 General Electric Company Système, méthode et formule pour le calcul de la mesure d'un stent
WO2010150145A1 (fr) 2009-06-23 2010-12-29 Koninklijke Philips Electronics N.V. Support de dimensionnement de dispositif lors d'interventions
US8655042B2 (en) 2009-06-23 2014-02-18 Koninklijke Philips N.V. Device sizing support during interventions
US10543117B2 (en) 2015-02-20 2020-01-28 Cook Medical Technologies Llc Duet stent deployment system and method of performing a transjugular intrahepatic portosystemic shunting procedure using same
EP4445835A3 (fr) * 2017-02-24 2025-01-22 HeartFlow, Inc. Systèmes et procédés d'identification de caractéristiques de flux sanguin anatomiquement pertinentes chez un patient

Also Published As

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