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WO2001024683A2 - Calibreur de lesions interventionnel pour applications vasculaires et non vasculaires - Google Patents

Calibreur de lesions interventionnel pour applications vasculaires et non vasculaires Download PDF

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Publication number
WO2001024683A2
WO2001024683A2 PCT/US2000/027440 US0027440W WO0124683A2 WO 2001024683 A2 WO2001024683 A2 WO 2001024683A2 US 0027440 W US0027440 W US 0027440W WO 0124683 A2 WO0124683 A2 WO 0124683A2
Authority
WO
WIPO (PCT)
Prior art keywords
interventional
injury
radiopaque
distal
radiation source
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/US2000/027440
Other languages
English (en)
Other versions
WO2001024683A3 (fr
Inventor
Thomas K. Brooks
Richard M. Griffith
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.)
Novoste Corp
Original Assignee
Novoste Corp
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 Novoste Corp filed Critical Novoste Corp
Priority to AU11918/01A priority Critical patent/AU1191801A/en
Publication of WO2001024683A2 publication Critical patent/WO2001024683A2/fr
Publication of WO2001024683A3 publication Critical patent/WO2001024683A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1001—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy using radiation sources introduced into or applied onto the body; brachytherapy
    • A61N5/1002—Intraluminal radiation therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • A61N5/1048—Monitoring, verifying, controlling systems and methods

Definitions

  • the present invention generally relates to an elongated wire being capable of navigating the vascular system or intraluminal passageways of a patient and having radiopaque markers strategically placed along the distal end of the wire for use as a tool to accurately measure the injury length of a vessel or other intraluminal passageway that has been subjected to an interventional procedure, such as balloon angioplasty, atherectomy or stent placement, and to accurately position a catheter or other such device within a vessel or intraluminal passageway.
  • an interventional procedure such as balloon angioplasty, atherectomy or stent placement
  • Intraluminal passageways can experience stenosis, the narrowing or stricture of human passageways.
  • partial and complete blockage of vessels can be attributed to fatty and fibrous substances deposited in the vessel walls
  • Such blockages may be treated using any one of a number of devices and procedures that have the objective to eliminate or at least reduce the blockage and increase the cross-luminal diameter, thus increasing blood flow
  • the most common of such procedures is percutaneous transluminal coronary angioplasty (PTCA), which is more commonly referred to as balloon angioplasty
  • PTCA percutaneous transluminal coronary angioplasty
  • a balloon catheter is introduced into the vessel, the umnflated balloon at the distal end of the balloon catheter is positioned at the stenotic site, and the balloon is inflated Inflation of the balloon disrupts and compresses the plaque and fibrous tissue against the vessel wall and stretches the vessel wall, resulting in enlargement of the intraluminal passageway and increased blood flow
  • the balloon is then deflated and the balloon catheter is
  • Geographic Miss is most commonly a result of ( 1 ) incorrect positioning of the catheter and/or radiation source relative to the injury site; and/or (2) delivering less than the effective radiation source length.
  • the effective radiation source length is at least as long as the injury length but may be required to extend beyond the edge of the injury to compensate for "edge effect", which is defined as the situation where the proximal and distal ends of the injury length are underdosed due to the decaying dose rate that has been associated with the proximal and distal edges of the radiation source.
  • the length of an injury created during an interventional procedure is very difficult to determine.
  • a 20 mm balloon does not necessarily create a 20 mm injury site.
  • Balloon lengths are often longer than specified, and balloons lengthen as the inflation pressures increase. Multiple balloon inflations while repositioning the balloon catheter along the stenotic site may also result in long injury lengths greater than that of the balloon.
  • Length assessment can further be hindered by vessel foreshortening, heart movement, and the use of flawed or crude methodologies. An inaccurate length assessment correlates to an ineffective radiation source length, resulting in Geographic Miss. To optimize the effectiveness of radiation therapy for the prevention and treatment of restenosis, the occurrence of Geographic Miss must be eliminated.
  • a technique and/or tool for accurately and precisely measuring the interventional injury length, which has become a crucial element in determining the corresponding effective radiation source length.
  • the main objectiv e of the invention is to assist with the accurate and precise determination of the effective radiation source length that will deliver the prescribed radiation or brachytherapy dosage to a targeted site within a patient.
  • an interventional measu ⁇ ng tool that comprises an elongated wire having a proximal section, a distal section, and an intermediate section therebetween, and two oi more radiopaque markers affixed to the distal section of said elongated wire, said radiopaque markers spaced at predetermined distances that indicate to the user the effective length of the radiation source that will provide for effective radiation dosing of the targeted tissue being treated.
  • the wire may have sufficient stiffness and flexibility to navigate the vascular system of a patient
  • the first and second radiopaque markers are spaced about 30 mm apart ⁇ thu d ladiopaque marker may be added and spaced about 40 mm horn the first radiopaque marker, and a fourth radiopaque marker may be added and spaced about 60 mm fiom the first radiopaque marker
  • the wire may comprise a handle along its proximal section for easier manipulation and positioning of the wire within the body of a patient, and the handle may comprise a clip for gripping the distal end of said elongated wire for manageability when said tool is not in use
  • Figure 1 is a segmented plan view of the interventional injury sizing tool according to the present invention. DETAILED DESCRIPTION OF INVENTION
  • the interventional injury sizing tool 10 of the present invention is an elongated flexible solid w ire 1 1 having a proximal portion 12 of a uniform ⁇ diameter, a distal portion 16 of a smaller uniform diameter, and a tapered intermediate portion 14 that facilitates the transition from the larger diameter proximal portion 12 to the smaller diameter distal portion 16
  • Two or more radiopaque markers 18 are attached to the distal portion 16 of the wire 1 1 1
  • One of said maikers 1 8 is attached to the distal tip of the distal portion 16 and the additional 0 maikeis 18 are spaced at predetermined distances from said distal tip marker 18 to Li LJtt a iriLJsiii ing tool foi accurately sizing a v ascular or other intraluminal injury to determine the radiation source length for effective radiation treatment of the injured tissue
  • the interventional injury sizing tool 10 is used to measure the length of intraluminal injuries l esulting horn interventional procedures, such as balloon angioplasty, atherectomy, and stent placement Therefore, it is designed to be maneuverable w ithin the asculai system and othei intraluminal passageways for the alignment of injured tissue with the distal radiopaque maikers 18, as can be readily v isible via 0 fluoroscopy
  • the larger diameter proximal portion 12 and the tapered intermediate poition 14 pi ov ide the needed stiffness to advance the wire 1 1 through the vascular system or other intraluminal passageways of a patient without damaging the luminal oi cjthetei walls, depending on whether it is being inserted directly into the intraluminal passage ay or through a catheter
  • the injury sizing tool 10 When inserted into a catheter that is ⁇ housing a guidewire oi 014 inch diameter, the injury sizing tool 10 , however, preferably does not create a catheter
  • the tapered intermediate section 14 provides a smooth transition between the stiffer proximal section 12 and the flexible distal section 16
  • the dimensions of the injury sizing tool 10 are directlv related to the dimensions of the catheter with which the sizing tool 10 is inserted and the dimensions of the radioactive source to be used to irradiate injured tissue
  • the length of the injury sizing tool 10 is longer than the catheter so that when in place it extends outside the proximal end of the catheter for purposes of manipulation by the user
  • the proximal section 12 ⁇ t the mjuiy sizing tool 10 has an outer diameter that is at least oi somewhat larger than that of the radiation source to be used for radiation treatment, and the distal section 16 of the injury sizing tool 10 has a diameter smaller than that of the pioximal section 12 to increase its flexibility
  • the intermediate section 14 is initially the diameter of the proximal section 12 and tapers down to the smaller diameter of the flexible distal section 16 For example, if the radiation source has an outei diametei ol 025 inch and the diametei of the cathetei lumen tor receiving the radiation source is
  • wn e 1 1 can be of any metal, such as stainless steel or nitinol, oi polvmer as long as it provides the ⁇ ght amount of flexibility and pushabihty to deliver it through the vasculature of a patient
  • the material may vary along the length of the wire 1 1
  • the wire 1 1 can be coated with a mate ⁇ al having a low coefficient of friction s
  • Radiopaque markers 18 that are readily visible under fluoroscopy are permanently affixed to the distal portion 16 of the elongated wire 1 1 Once the injury sizing tool 10 is fully inserted into the intraluminal passageway, the proximal end of the most distal ladiopaque marker 18 is aligned with the distal end of the injured site, and the
  • Radiopaque markers 18 may be spaced at equal or varied distances along the distal portion 16 of the injury sizing tool 10 It is preferable, however, that the radiopaque markers 1 8 are spaced at distances that correspond to the different
  • an injury sizing tool 10 specifically designed for coronary applications may have a first radiopaque marker 18 at its distal tip a second ladiopaque markei 18 proximally spaced 30 mm from the first
  • the injury sizing tool 10 may have additional radiopaque maikei s 18 spaced at 80 mm and 120 mm from the first radiopaque maiker 18 at the distal tip of the distal portion 16
  • the radiopaque markers 18 of the injury sizing tool 10 are of the same length as the 30 radiopaque markeis on either end of the radiation source, such as the radiopaque markei seeds positioned on each end of a series of radiation source seeds as referenced herein by the disclosures of U S Patent Nos 5, 683, 345, issued November 4, 1997 and 5, 899, 882 issued May 4, 1999
  • the radiation source seeds and two marker seeds are maintained in an end to end configuration with the most distal marker seed abutting a distal wall that impedes the forward motion of the radiation source seeds
  • the interventional injury sizing tool 10 is properly positioned within the catheter when the tool's distal tip, which happens to be the distal tip of the first and most distal ladiopaque marker 18, maintains contact with the distal wall in the same way as does the radiation source during radiation treatment Having the radiopaque markers 18 equal in length to that of the radiopaque segments of the radiation source and having the distance
  • Radiopaque markers 18 may also be of the same diameter as the radiation source and its radiopaque markei sections Positioning an injury sizing tool 10 having radiopaque markers 1 8 of both the same length and diameter as the radiation marker sections of the radiation source has the advantage of simulating the movement of the radiation source through the catheter to its placement at the distal end of the catheter.
  • the injury sizing tool 10 cannot be advanced to the injury site then it stands to reason that the radiation source most likely would also be incapable of being fully advanced
  • the radiopaque markers 18 be of a diameter that allows for easy removal of the injury sizing tool 10 without significant displacement of the distal portion of the catheter, preferably no more than one millimeter deflection when the catheter is placed in a bend of no less than 25 inch in radius Any more deflection and the catheter is no longer withm proper position to provide effective radiation treatment
  • the radiopaque markers 18 may have a slightly larger outer diameter than the distal portion 16 of wire 1 1 , or the distal portion 16 may be undercut where the radiopaque markers 18 are permanently affixed, creating a uniform diameter along the entire length of the distal portion 16 of the wire 1 1
  • the radiopaque markers 18 are of a larger diameter than the distal portion 16 of the wire 1 1
  • non-radiopaque sections of l ⁇ the same outer diameter as the radiopaque markers 1 8 may reside in between the ladiopaque markers 18 to create a uniform diameter from the distal tip to the proximal end of the most proximal radiopaque marker 18
  • the radiopaque markers 18 can be bands oi coils made of any radiopaque material, such as gold, platinum, or platinum indium oi platinum tungsten alloys Although the radiopaque markers 1 8 could be
  • the radiopaque markers 18 are preferably welded to the distal end 16 of the wire 1 1 to create a strong and lasting bond
  • the injury sizing tool 10 may 20 hav e one or moie proximal depth markeis (not shown ) on the proximal wire portion 12 that gives the physician an indication of the working length of the catheter and vvheie it is within the intraluminal passageway
  • a handle (not shown) mav be securely attached to the proximal end of the wire 1 1 for 2s easiei manipulation and positioning of the injury sizing tool 10
  • a clip or slot mav be integrated into the handle to securely grip the distal end of the injury sizing tool 10 when not in use and outside the catheter The clip will make it easier to maintain the elongated injury sizing tool 10 in a coiled or other manageable position during shipping and handling
  • the main focus of the interventional injury sizing tool 10 is to provide a device that can accurately and precisely measure the length of an injured site to deliver the effective radiation source length and eliminate the occurrence of Geographic Miss.
  • the interventional injury sizing tool 10 has additional built in features for contributing to the overall improvement of the radiation therapy procedure.
  • the interventional injury sizing tool 10 can be inserted directly into the intraluminal passageway, directly into the radiation source lumen of a radiation delivery catheter prepositioned with the intraluminal passageway, or indirectly into the intraluminal passageway by being preinserted into the radiation source lumen of a radiation delivery catheter and carried to the injury site by placement of the catheter.
  • the built in design features come into play when the injury sizing tool 10 is being used in conjunction with a catheter.
  • the radiation sources may be a series of individual seeds. A series of steps are completed to deliver non-radioactive seeds to the distal end of the catheter as a trial run to determine the patency of the radiation source lumen of the catheter in use.
  • the injury sizing tool 10 By inserting the injury sizing tool 10 within the radiation source lumen of the catheter, either before or after the catheter is placed within the intraluminal passageway, the dummy run is no longer needed. Since the markers I S are of the same diameter as the radiation sources, successful placement oi ' the injury sizing tool 10 within the catheter ' s source lumen assures the physician that the lumen is patent and indicates successful placement of the radiation sources.
  • an advantage of pre-inserting the injury sizing tool 10 within the catheter prior to packaging is that it maintains the source lumen open during shipping and handling of the catheter and prevents the source lumens from becoming kinked or collapsed.
  • a radiation delivery catheter will be advanced over a prepositioned guidewire and through a prepositioned guide catheter to the intraluminal injury for treatment.
  • a hemostasis valve such as a Touhy Bourst valve, is clamped to the guide cathetei and is tightened down around the guide catheter and radiation delivery catheter until the space between the two is closed off preventing back flow of blood from escaping the proximal end of the guide catheter Overaggressive tightening of the hemostasis valve will constrict the delivery catheter's source lumen, reducing it to a diameter smaller than the radiation sources and either crushing the radiation sources or obstiucting their pathway
  • an injury sizing tool 10 having a proximal portion 12 of a larger diameter than the radiation source is inserted into the radiation source lumen of the delivery catheter, if not already prepackaged that way The hemostasis valve cannot constrict the catheter's radiation source lumen to a diameter less than that of the proximal portion
  • the interventional injury sizing tool 10 of the present invention can be used in conjunction with any catheter, radiation source, and radiation delivery system to assess the tieatment length and position needed for effective radiation treatment

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Pathology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Radiation-Therapy Devices (AREA)

Abstract

La présente invention concerne un outil de mesure permettant une évaluation exacte et précise de la longueur de source de rayonnement devant fournir la dose prescrite de rayonnement ou de brachythérapie au site visé de l'anatomie d'un patient. Ce calibreur interventionnel comprend un fil long définissant un segment proximal, un segment distal et un segment intermédiaire, et au moins deux marqueurs radio-opaques fixés au segment distal du fil long. Ces marqueurs radio-opaques respectent entre eux des distances qui indiquent à l'utilisateur la longueur efficace de la source de rayonnement qui apportera la dose efficace de rayonnement au tissu visé à traiter. Ce fil peut présenter une certaine rigidité et une certaine souplesse lui permettant la navigation dans le système vasculaire du patient. Pour l'une des réalisations, le premier marqueur radio-opaque et le deuxième marqueur radio-opaque respectent entre eux in intervalle d'environ 30 mm. Un troisième marqueur radio-opaque peut être ajouté à 40 mm du premier marqueur radio-opaque, ainsi qu'un quatrième marqueur radio-opaque à environ 60 mm du premier marqueur radio-opaque. En outre, le fil peut comporter une poignée le long de son segment proximal de façon à faciliter la manipulation et le positionnement du fil dans de l'anatomie du patient. En l'occurrence, cette poignée comporte une pince permettant de saisir l'extrémité distale du fil long pour la gérabilité du calibreur en dehors de son utilisation.
PCT/US2000/027440 1999-10-04 2000-10-04 Calibreur de lesions interventionnel pour applications vasculaires et non vasculaires Ceased WO2001024683A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU11918/01A AU1191801A (en) 1999-10-04 2000-10-04 Interventional injury sizing tool for vascular and non-vascular applications

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US15749699P 1999-10-04 1999-10-04
US60/157,496 1999-10-04

Publications (2)

Publication Number Publication Date
WO2001024683A2 true WO2001024683A2 (fr) 2001-04-12
WO2001024683A3 WO2001024683A3 (fr) 2001-06-14

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PCT/US2000/027440 Ceased WO2001024683A2 (fr) 1999-10-04 2000-10-04 Calibreur de lesions interventionnel pour applications vasculaires et non vasculaires

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AU (1) AU1191801A (fr)
WO (1) WO2001024683A2 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104757973A (zh) * 2015-04-10 2015-07-08 张志辉 一种诊断治疗用导管

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5465732A (en) * 1992-03-31 1995-11-14 Boston Scientific Corporation Fluoroscopically viewable multifilar calibrated guidewire and method of measuring occlusions with calibrated guidewires
US5409015A (en) * 1993-05-11 1995-04-25 Target Therapeutics, Inc. Deformable tip super elastic guidewire
US5479938A (en) * 1994-02-07 1996-01-02 Cordis Corporation Lumen diameter reference guidewire
US5606981A (en) * 1994-03-11 1997-03-04 C. R. Bard, Inc. Catheter guidewire with radiopaque markers

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104757973A (zh) * 2015-04-10 2015-07-08 张志辉 一种诊断治疗用导管
CN104757973B (zh) * 2015-04-10 2018-05-29 张志辉 一种诊断治疗用导管

Also Published As

Publication number Publication date
AU1191801A (en) 2001-05-10
WO2001024683A3 (fr) 2001-06-14

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