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WO1998000059A1 - Systeme d'implantation et de mesure et procede de reparation des aberrations vesiculeuses - Google Patents

Systeme d'implantation et de mesure et procede de reparation des aberrations vesiculeuses Download PDF

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Publication number
WO1998000059A1
WO1998000059A1 PCT/US1997/011666 US9711666W WO9800059A1 WO 1998000059 A1 WO1998000059 A1 WO 1998000059A1 US 9711666 W US9711666 W US 9711666W WO 9800059 A1 WO9800059 A1 WO 9800059A1
Authority
WO
WIPO (PCT)
Prior art keywords
vesicular
aberration
vessel
insert
scale
Prior art date
Application number
PCT/US1997/011666
Other languages
English (en)
Inventor
Dilip Bobra
Original Assignee
Dilip Bobra
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 Dilip Bobra filed Critical Dilip Bobra
Priority to AU37942/97A priority Critical patent/AU3794297A/en
Publication of WO1998000059A1 publication Critical patent/WO1998000059A1/fr

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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
    • A61F2/95—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
    • 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
    • A61B90/06—Measuring instruments not otherwise provided for
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0097—Visible markings, e.g. indicia

Definitions

  • This invention relates to medical devices. More particularly, this invention relates to medical devices for repairing soft tissue. In a further and more specific aspect, the instant invention relates to an implantation apparatus and system for aiding the repair of vesicular aberrations.
  • the human cardiovascular system is a closed tubular system in which blood, propelled by a muscular heart, flows through vessels to and from all parts of the body.
  • Two circuits, the pulmonary and the systemic, consist of arterial, capillary, and venous components.
  • venules As the venules continue to increase m size, they begin to exhibit the wall structure characteristic of arteries, though much thinner. Venules eventually lead to veins, which function to conduct blood from peripheral tissues to the heart. Veins tend to follow a course parallel to that of arteries, but are present in greater numbers. Arteries and veins are unfortunately prone to a variety of maladies which can inhibit the flow of blood ultimately causing substantial and serious bodily injury.
  • the coronary arteries which originate in the aorta and supply blood to the muscular tissue of the heart, can be susceptible to atherosclerosis which is characterized by the narrowing of the artery from the deposition of atheromatous plaques containing cholesterol and lipids.
  • the prior art has provided certain procedures for correcting atherosclerosis. If an artery is incompletely obstructed, medication can be used for clearing the obstruction. Another commonly used technique is to surgically bypass around the diseased portion with a vein segment if medication is not effective. Carbon dioxide endarectomy is also performed. In this operation, carbon dioxide is introduced directly into the obstructed coronary artery. The carbon dioxide tends to loosen the inner atheromatous core from the artery thereby restoring blood flow through the affected artery. In both procedures, a heart-lung machine s used to support the circulation. Although both of the above-mentioned procedures are exemplary, they are notably expensive, and patient recovery can be considerable, further adding to the expense.
  • balloon angioplasty the balloons can be inflated by compressed air at different controlled pressures. They are used for dilation of a partly obstructed coronary artery, with restoration of blood flow to the heart muscle, and of a severely obstructed heart valve. This procedure generally requires no anesthetic and, using specialized radiological imaging techniques, is sometimes done on an outpatient basis.
  • coronary arteries may be dilated in this way, with flattening of the atheromatous material against and into the arterial wall.
  • occlusive diseases are arteriosclerosis, arterial thrombosis, and arterial embolism.
  • Common nonocclusive maladies are arte ⁇ ovenous fistula, which is characterized as a penetrating injury resulting in an opening between an artery and its immediately adjacent vein, and aneurysms, which are characterized as the bulging of an arterial wall at a point of weakness. Aneurysms can result m pain and may occasion sudden death if they rupture. Like the corrective procedures described above in relation to the coronary arteries, they may similarly be used for correcting such occlusive diseases and arteriovenous fistula.
  • veins are similarly prone to occlusive and nonocclusive vesicular aberrations, such as blood clots and direct mechanical injury. Like the arteries, veins may similarly be repaired either medically, surgically, or perhaps with angioplasty if needed.
  • a repair apparatus or vesicular insert, that is introduced into the affected vessel for placement proximate a malodorous area.
  • the insert commonly referred to as a stent, is comprised of a mesh of shape retaining material operative for introduction into a vessel for distending the vessel outwardly for restoring the proper flow of blood through the vessel.
  • the stent is normally permanently introduced into the affected vessel, and results have been exemplary for the restoration of blood flown.
  • occlusive maladies and vessel constrictive maladies suitable for repair by the stent normally extend over a varying area or length of an affected vessel. Some of these maladies can be quite extensive in size, while others not so. Thus, stents having varying sizes are needed for vesicular maladies having varying sizes. In order to select an appropriately sized stent for effecting repair of a vesicular malady, one must guess the proper size and hope that it is suitably sized only after insertion within the affected vessel. If not properly sized, a variety of problems can and normally do occur.
  • an apparatus for ascertaining the extent of a vesicular aberration of a vessel of an animal such as a human being includes an insert having graduations receivable into and through the vessel for placement proximate the vesicular aberration.
  • the graduations are detectable and viewable by an imaging means for allowing a user to ascertain the extent of the vesicular aberration.
  • the apparatus may further include a catheter for introducing a repair apparatus through a bore of the insert suitably sized for placement proximate the vesicular aberration for effecting repair of the vesicular aberration.
  • the repair apparatus may be provided as a stent.
  • a system for ascertaining the extent of a vesicular aberration of a vessel of an animal is comprised of a measuring apparatus receivable into and through the vessel for placement proximate the vesicular aberration, the measuring apparatus having graduations.
  • the system further includes imaging means for viewing the graduations and the vesicular aberration for allowing a user to ascertain the extent of the vesicular aberration for the purpose of diagnosis.
  • a method of ascertaining the extent of a vesicular aberration of a vessel of an animal comprising the steps of providing a measuring apparatus, inserting the measuring apparatus into and through the vessel for placement proximate the vesicular aberration, and measuring the vesicular aberration with the use of an imaging means for projecting an image of the graduations and the vesicular aberration.
  • Still further provided is a method of repairing a vesicular aberration of a vessel of an animal comprising the steps of measuring the extent of the vesicular aberration, selecting a repair apparatus suitable for repairing the vesicular aberration, and implanting the repair apparatus proximate the vesicular aberration for effecting repair of the vesicular aberration.
  • Fig. 1 is a perspective v ew of an embodiment of an implantation and measuring apparatus for ascertaining the extent of a vesicular aberration and for introducing a repair element into a vessel;
  • Fig. 2 is the implantation and measuring apparatus of Fig. 1 shown as it would appear in use for introducing a stent into and through a vessel for repairing a vesicular malady;
  • Fig. 3 is a fragmented view of the implantation and measuring device of Fig. 1, further illustrating graduations formed therewith;
  • Fig. 4 is a perspective view of a monitor of a diagnostic imaging apparatus
  • Fig. 5 is a perspective view of a scanner of the diagnostic imaging apparatus operative for emitting electromagnetic radiation for allowing a user to view the internal structure of an animal on the monitor of Fig. 7;
  • F g. 6 is an enlarged view of a stent shown as it would appear carried upon an outer end of a catheter extending through an insert of the implantation and measuring device shown in Fig. 1; and
  • Fig. 7 is a view illustrating the implantation and measuring apparatus of Fig. 1 as it would appear inserted with the vessel of Fig. 2, and further illustrating how graduations carried by the implantation and measuring apparatus may be employed for ascertaining the extent of the vesicular malady.
  • Fig. 1 illustrates an implantation and measuring apparatus being generally designated by the reference character 20.
  • Apparatus 20 is comprised of an insert 25 herein defined as a hollow, flexible tube 26 for insertion into a body cavity, duct, or vessel of an animal such as a human being.
  • Tube 26 having a substantially elongate configuration and being suitably constructed of a substantially flexible material suitable for insertion into an animal, includes a substantially cylindrical outer surface 27, an open outer end 28, and an open inner end 29 having a finger flange 30 coupled thereto that a user may grip during use.
  • Tube 26 includes a substantially cylindrical inner surface (not shown) defining a bore 31 extending from second open end 29 to first open end 28.
  • Tube 26 further includes a scale 34 defined by graduations 35 carried by and extending along substantially the entire length of tube 26 from second end 29 to first end 28.
  • graduations 35 may be carried by other portions of insert 25 as suitably desired, graduations 35 are preferably formed upon substantially cylindrical outer surface 27 m equally spaced-apart and substantially linear alignment to coincide to a predetermined and preselected measuring scale for allowing a user to measure the extent or size of a particular object, the specific details of which will be herein specifically described as the detailed description ensues.
  • catheter 40 includes a hollow, flexible tube 41 for insertion into a body cavity, duct, or vessel of an animal such as a human being.
  • Tube 41 having a diameter less than the diameter of tube 26, a substantially elongate configuration and being suitably constructed of a substantially flexible material suitable for insertion into an animal, includes a substantially cylindrical outer surface 42, an open outer end 43 extendible through and beyond outer end 28 of insert 25, and an open inner end 44 having an attachment
  • Attachment 45 is detachably engagable to other medical instrumentation as desired by a medical practitioner for carrying out certain and specific medical procedures, details of which will not be herein specifically addressed as they will be readily apparent to those having ordinary skill.
  • Apparatus 20 may be employed for carrying out a wide variety of specific medical procedures. However, with respect to the instant discussion, application of apparatus 20 will be discussed in combination with the repair of a diseased or damaged region of a vessel such as a an occlusive and non-occlusive vesicular malady.
  • Fig. 2 illustrating a portion of a human leg 50 having a vessel 51 passing therethrough, which could be either an artery or a vein operative for communicating blood.
  • Vessel 51 is further shown damaged or afflicted with a vesicular aberration illustrated generally as a bulge in vessel 51 being generally designated at 52.
  • the outer ends 28 and 43 of apparatus 20 are shown having been inserted through an incision 53 formed through leg 50 and further nto and through vessel 51 for placement of outer ends 28 and 43 proximate vesicular aberration 52.
  • the object of the procedure being described is to effect repair of vesicular aberration 52 through the placement of a stent 54 at the location of vesicular aberration 52.
  • Stent 54 shown more completely in Fig. 6, is well known to those having ordinary skill for repairing specific vesicular aberrations, and is generally comprised of a framework 60.
  • Framework 60 includes a mesh 61 of shape retaining material comprising a plurality of filaments 62 coupled together in meshing engagement, filaments 62 being constructed of shape retaining stainless steel, or other shape retaining substance suitable for introduction into the human body.
  • Framework 60 includes a mesh 61 of shape retaining material comprising a plurality of filaments 62 coupled together in meshing engagement, filaments 62 being constructed of shape retaining stainless steel, or other shape retaining substance suitable for introduction into the human body.
  • 60 further includes a first open end 63, a second open end
  • Stent 54 is typical, and those having ordinary skill will readily understand that stent 54 is movable between a normal expanded configuration and a collapsed configuration, details of which are not shown in the drawings and will not be herein further discussed m great detail except to the extent necessary to provide a full and clear disclosure of the instant invention as herein specifically described.
  • Stent 54 is operative for repairing specific vesicular aberrations affecting blood vessels within either the arterial or venous components of the circulatory system.
  • the flow of blood through the arterial or venous components of the circulatory system of living organisms such as humans and certain other animal species can be impeded as a result of occlusive disorders, or nonocclusive disorders.
  • Occlusive disorders as previously discussed, are characterized as blockages or obstructions formed or deposited within a blood vessel.
  • Nonocclusive disorders can include aneurysms and arte ⁇ ovesicular fistula resulting from penetrating injury caused by a bullet or a sharp object. With placement of stent 54 within a vessel proximate the diseased or damaged region, repair may be effected.
  • a method of placing or introducing stent 54 proximate vessel 51 for effecting repair of a damaged or diseased portion of vessel 51 can be seen with reference back to Fig. 2.
  • catheter 40 having stent 54 carried thereon.
  • the positioning of stent 54 in vessel 54 would normally be carried out by first inserting outer end 28 of insert 25 into vessel 54 for placement proximate vesicular aberration 52.
  • stent 54 would be placed upon portions of catheter 40 proximate outer end 43 and then plunged through bore 31 of insert 25, outer end 43 of catheter 40 being further plunged or extended beyond outer end 28 of insert 25 for introduction of stent into vessel 51 proximate vesicular aberration 52 needing repair, clearly shown in Fig. 2.
  • stent 54 is removed from catheter 40 and catheter 40 then pulled back through insert 25.
  • catheter 40 When catheter 40 is removed, stent 54 assumes the normal expanded configuration as a result of the shape memory inherent with filaments 62.
  • filaments 62 impinge against the inner surface of vessel 51 thereby effecting repair of vesicular aberration 52.
  • stent 54 may be selectively housed about a balloon of a conventional balloon catheter and secured within a vessel by inflating the balloon, the balloon then deflated for removal from the vessel .
  • Graduations 35 which can be seen more fully in combination with Fig. 3, are employed for this purpose of measuring the extent of the vesicular aberration so that a properly sized stent 54 may be selected.
  • graduations 35 are provided to be detectable when inside and concealed by vessel 51 by means of a suitable imaging device. Although other means may be used, graduations 35, employed in combination with a suitable imaging device, are the preferred means of measuring vesicular aberrations.
  • stent 54 has been herein disclosed as a repair apparatus for repairing a specific variety of vesicular aberration, it will be readily understood that apparatus 20 may be used in combination with other repair devices currently used to aid in the repair of diseased or damaged portions of vessels.
  • Figs. 4 and 5 illustrate how a vesicular aberration can be measured prior to selection and subsequent implantation of a repair device for effecting repair of a diseased or damaged portion of a vessel.
  • Fig. 5 illustrates insert 25 and catheter 40 of apparatus 20 inserted within incision 53 formed through human leg 50 and vessel 51, and further inserted into and through portions of a vessel 51 (not shown in Fig. 5) .
  • diagnostic imaging apparatus 73 incorporates the use of electromagnetic radiation to produce images of internal structures of an animal for the purpose of accurate diagnosis. It will be readily understood by those having ordinary skill that diagnostic imaging is roughly equivalent to radiology, the branch of medicine that uses radiation to diagnose and treat diseases.
  • scanner 73 is placed proximate leg 71 and emits electromagnetic radiation into leg 71 providing an image of internal structures of leg 71, and apparatus 20, on a screen 75 of a conventional monitor 74 which is part of the diagnostic imaging apparatus 73.
  • the image, generally designated at 76, provided on screen 75 of monitor 74 can be seen as showing outer ends 28 and 43 of insert 25 and catheter 40, respectively, of apparatus 20 inserted within vessel 51 proximate vesicular aberration 52.
  • Graduations 35 detectable by scanner 72 and also shown in image 76 projected on monitor 74, are viewable on monitor 74 for measuring the extent or size of vesicular aberration 52 affecting vessel 51.
  • FIG. 7 illustrates a more detailed view of vesicular aberration 52 affecting vessel 51 as it might appear on screen 75 of monitor 74 with insert 25 of apparatus 20 placed therethrough.
  • graduations 35 may be positioned and viewed for measuring the length or extent of vesicular aberration 52 so that an appropriately size ⁇ stent 54 or other selecte ⁇ repair apparatus may be selected and then inserte ⁇ for placement proximate the vesicular aberration for effecting repair.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Vascular Medicine (AREA)
  • Transplantation (AREA)
  • Cardiology (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • High Energy & Nuclear Physics (AREA)
  • Optics & Photonics (AREA)
  • Radiology & Medical Imaging (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention porte sur un système d'implantation et de mesure qui permet de déterminer l'ampleur d'une aberration vésiculeuse d'un vaisseau d'un animal et de réparer ladite aberration. Ce système comprend un insert (25) gradué capable de pénétrer à l'intérieur du vaisseau et à travers celui-ci pour être placé à côté de l'aberration vésiculeuse, les graduations (35) pouvant être détectées et visualisées par un imageur grâce auquel l'utilisateur peut déterminer l'ampleur de l'aberration vésiculeuse, et un cathéter (40) permettant d'introduire un appareil de réparation dont la taille permet de le placer juste à côté de l'aberration vésiculeuse en vue de la réparation de l'aberration.
PCT/US1997/011666 1996-07-03 1997-07-02 Systeme d'implantation et de mesure et procede de reparation des aberrations vesiculeuses WO1998000059A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU37942/97A AU3794297A (en) 1996-07-03 1997-07-02 Implantation and measuring system and method for repairing vesicular aberrations

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US67585196A 1996-07-03 1996-07-03
US08/675,851 1996-07-03

Publications (1)

Publication Number Publication Date
WO1998000059A1 true WO1998000059A1 (fr) 1998-01-08

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AU (1) AU3794297A (fr)
WO (1) WO1998000059A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7464712B2 (en) 1997-06-27 2008-12-16 The Trustees Of Columbia University In The City Of New York Method and apparatus for circulatory valve repair

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4173228A (en) * 1977-05-16 1979-11-06 Applied Medical Devices Catheter locating device
US4431005A (en) * 1981-05-07 1984-02-14 Mccormick Laboratories, Inc. Method of and apparatus for determining very accurately the position of a device inside biological tissue
US5161536A (en) * 1991-03-22 1992-11-10 Catheter Technology Ultrasonic position indicating apparatus and methods
US5257636A (en) * 1991-04-02 1993-11-02 Steven J. White Apparatus for determining position of an endothracheal tube
US5318025A (en) * 1992-04-01 1994-06-07 General Electric Company Tracking system to monitor the position and orientation of a device using multiplexed magnetic resonance detection
US5425382A (en) * 1993-09-14 1995-06-20 University Of Washington Apparatus and method for locating a medical tube in the body of a patient
US5558091A (en) * 1993-10-06 1996-09-24 Biosense, Inc. Magnetic determination of position and orientation
US5592939A (en) * 1995-06-14 1997-01-14 Martinelli; Michael A. Method and system for navigating a catheter probe

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4173228A (en) * 1977-05-16 1979-11-06 Applied Medical Devices Catheter locating device
US4431005A (en) * 1981-05-07 1984-02-14 Mccormick Laboratories, Inc. Method of and apparatus for determining very accurately the position of a device inside biological tissue
US5161536A (en) * 1991-03-22 1992-11-10 Catheter Technology Ultrasonic position indicating apparatus and methods
US5257636A (en) * 1991-04-02 1993-11-02 Steven J. White Apparatus for determining position of an endothracheal tube
US5318025A (en) * 1992-04-01 1994-06-07 General Electric Company Tracking system to monitor the position and orientation of a device using multiplexed magnetic resonance detection
US5425382A (en) * 1993-09-14 1995-06-20 University Of Washington Apparatus and method for locating a medical tube in the body of a patient
US5558091A (en) * 1993-10-06 1996-09-24 Biosense, Inc. Magnetic determination of position and orientation
US5592939A (en) * 1995-06-14 1997-01-14 Martinelli; Michael A. Method and system for navigating a catheter probe

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7464712B2 (en) 1997-06-27 2008-12-16 The Trustees Of Columbia University In The City Of New York Method and apparatus for circulatory valve repair

Also Published As

Publication number Publication date
AU3794297A (en) 1998-01-21

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