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WO1992019161A1 - Sonde vasculaire - Google Patents

Sonde vasculaire Download PDF

Info

Publication number
WO1992019161A1
WO1992019161A1 PCT/US1992/000800 US9200800W WO9219161A1 WO 1992019161 A1 WO1992019161 A1 WO 1992019161A1 US 9200800 W US9200800 W US 9200800W WO 9219161 A1 WO9219161 A1 WO 9219161A1
Authority
WO
WIPO (PCT)
Prior art keywords
probe
vessel
stem
surgical probe
smooth
Prior art date
Application number
PCT/US1992/000800
Other languages
English (en)
Inventor
Francis Robicsek
Original Assignee
Bio-Vascular, 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 Bio-Vascular, Inc. filed Critical Bio-Vascular, Inc.
Publication of WO1992019161A1 publication Critical patent/WO1992019161A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12027—Type of occlusion
    • A61B17/1204—Type of occlusion temporary occlusion
    • A61B17/12045—Type of occlusion temporary occlusion double occlusion, e.g. during anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • 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
    • 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
    • A61B90/90—Identification means for patients or instruments, e.g. tags
    • A61B90/92—Identification means for patients or instruments, e.g. tags coded with colour
    • 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

Definitions

  • This invention relates generally to the design of surgical instruments and devices and more particularly to a combination vascular probe and retractor.
  • This vascular probe is inserted within the vascular system by cardiac, vascular and cardiovascular surgeons during cardiac or vascular surgery. It is used for medical procedures such as calibrating blood vessels, occluding blood vessels, and identifying stenotic lesions remote from the site of an anastomosis, among others.
  • Surgical instruments for the separation or obturation of tissue or ducts typically feature a generally blunt or conical tip, often mounted on a shaft, and generally having a discrete handle portion for grasping by the surgeon.
  • U.S. Patent 4,959,067 discloses a tissue separating bulbous tip on a flexible stem.
  • This device is intended for use in separating tissue and features a straight, elongated shaft having a handle portion at one end.
  • An associated flexible stem extending from this shaft provides controlled flexibility.
  • the stem terminates in a spherical tip which is designed to snap onto the end of the stem and held there by an adhesive.
  • this stem and tip may be integrally molded.
  • the handle and tips are preferably luminescent and colored to provide a visual indication of their positions when submerged in tissue.
  • the device has a main stem with a bar at one end.
  • the bar is formed by a pair of opposing arms.
  • a solid bulb is positioned at each end of the bar.
  • the bulbs are generally conical or bullet shaped and are intended to be inserted within a coronary artery through an incision made at the location where a bypass graft is to be affixed. In use, an incision is prepared in the wall of a blood vessel which is approximately equivalent in length to one arm of the bar.
  • a duct dilator is disclosed in U.S. Patent No. 3,196,876, issued to Maurice M. Miller on July 27, 1965. This device has two portions, each terminating in a bulbous region.
  • the substantially rigid handle portion is approximately ten inches long, while the attached malleable probe portion is about five inches long.
  • the malleable probe portion terminates in an enlarged oval tip.
  • a sleeve dilator having a central bore extends over the probe portion.
  • the sleeve dilators are dimensioned slightly larger than the diameter of the malleable probe, yet slightly smaller than the diameter of the enlarged oval tip.
  • the sleeve is pushed down over the handle and progressed forward over the entire length of the malleable probe until its tip reaches and is stopped by the probe's enlarged oval tip.
  • the sleeve dilators are available in a variety of signs wherein the tip end of each is also oval shaped and slightly enlarged.
  • the diameter of the tip of the first sleeve is about one millimeter larger than the diameter of the probe tip.
  • the probe tip is approximately three millimeters in diameter. The various sleeves may thus be progressively introduced until an appropriate dilation is attained.
  • U.S. Patent No. 2,221,138 issued on November 12, 1940 to F. C. Hendrickson, describes a tapered bougie for exploring and treating strictures. It has a tapered metal core formed of a plurality of fine wires. The number of these wires present within succeeding sections is reduced along the length of the device so as to give it a taper.
  • the tapered wires are comprised of a combination of spring wire and soft annealed wire in order to lend a memory property. This device can be attached to the end of another instrument and used as a dilator.
  • probes are useful in maintaining accuracy of suture placement, maintenance of a dry operative field (prevent retrograde/antegrade bleeding into an anastomotic site) , calibration of the internal diameter of an artery, localization and calibration of stenotic lesions remote from the anastomotic site, dilatation of stenotic areas, dilatation of the corners of anastomoses, clear identification of the lumen of a vessel, prevention of coronary air embolism, identification of the course of an artery and localization of major tributaries, and avoidance of trauma to an artery by obviating the need for tourniquets or clamps to occlude flow.
  • the probes described have a cylindrical, 45 cm long shaft with a blunt end design for receiving a removable, stainless steel stylet insert at one end and a smooth olive tip at the other end.
  • a selection of sizes is available for the olive tips, graduated in outer diameter from 1.0 to 3.5 mm.
  • the shafts are either 1.0 or 1.55 mm in diameter. They are constructed of a reinforced fiber (Dacron) covered by polyurethane. The tips of these probes are elongated and somewhat pointed. To further avoid trauma to an artery, a tip having a more rounded design is desirable.
  • a combined vascular probe and retractor can be inserted within the vascular system by cardiac, vascular and cardiovascular surgeons during a cardiac or a vascular surgical procedure. It is used to calibrate, retract or occlude blood vessels, identify stenotic lesions remote from the site of an anastomosis, and maintain a dry surgical field.
  • the device features a disposable, flexible, coated shaft having a calibrated occluder bulb at each end. It is comprised of a flexible material such as an acrylic substrate and is coated with a material such as polyurethane to reduce friction as it is advanced within the lumen of a blood vessel. It is available in a variety of tip sizes.
  • a further object of the present invention is to provide a new and improved method and apparatus for such probing within a vessel using a device that is more flexible than those available in the prior art.
  • a still further object of the present invention is to provide a new and improved method and apparatus for introducing a probe into a vessel that minimizes the size of the hole in a vessel wall required for such procedures and does not require stretching or pulling of the vessel wall to accomplish such introduction.
  • Yet another object of the present invention is to provide a new and improved method and apparatus which will enable movement of the probe upstream or downstream within a vessel without requiring that the surgeon remove the device and reinsert it through an additional hole in the vessel wall.
  • Figure 2 depicts an enlarged, partial, side cut-away view of the embodiment of Figure 1;
  • Figures 3A, 3B and 3C depict the preferred embodiment in situ.
  • FIG. 1 A preferred embodiment of the combined vascular probe and retractor is shown in Figure 1. Generally depicted as
  • the vascular probe of the present invention features a generally cylindrical shaft 12 having bulbous heads 14 and 16 disposed at opposing ends of the cylindrical shaft 12.
  • the shaft 12 is dimensioned to enable the probe to be bent without breaking and component materials have been selected accordingly, as described more fully hereinafter.
  • the vascular probe 10 is of unitary construction.
  • the components have a base coated with a polyurethane plastic.
  • the polyurethane coating is advantageous to reduce friction between the probe 10 and an internal wall of the vessel being treated.
  • the preferred length of the flexible, cylindrical shaft 12 can vary. A suggested range for the length of the shaft 12 is from approximately 4 cm to 90 cm. Shafts having lengths of 80 mm (3.150") or 45 cm (17") would, for example, be appropriate.
  • the diameter of the shaft preferably falls within a range between 0.5 mm and 1.0 mm.
  • Each of the bulbous heads 14 and 16 are dimensioned to fit within the vessel in which the device is to be used. Their exteriors are smooth and unencumbered by edges which might tear the vascular wall.
  • a variety of vascular probes 10 having differing head sizes is preferably made available to the surgeon so that the surgeon can select the size best suited for the particular application. Color coding can be used to help the surgeon differentiate between the various sizes offered.
  • An appropriate assortment of probes 10 would include heads 14 and 16 of varying diameters and lengths. Suitable diameters generally fall in the range of 1.0 mm (0.039”) to 2.5 mm (0.098"). Suitable lengths generally fall in the range of 3.91 mm (0.154") to 5.36 mm (0.211").
  • the vascular probe 10 can be made so that the heads 12 and 14 are of different sizes. This reduces the likelihood of needing to open a second sterilized package containing a probe, due to an inappropriate size selection.
  • an 80 mm (3.150") shaft 12 may be coupled at one end with a bulb 14 having a diameter of 1.0 mm (0.039”) and a length of 3.91 mm (0.154”) and coupled at its other end with a bulb having a length of 5.00 mm (0.197”) and a diameter of 1.50 mm (0.059").
  • a similar probe may be fitted at one end with a 2.00 mm (0.079”) diameter, 5.00 mm (0.197”) length bulb and at the other end with a 2.50 mm (0.098") diameter, and 5.36 mm (0.211") length bulb.
  • the shaft 12 to which these bulbs are attached may be either 80.0 mm (3.150") or 450.0 mm (17.72").
  • the particular combination of sizes to be used during a procedure is selected on the basis of the internal diameter of the host vessel and the length of shaft required for easy manipulation by the surgeon.
  • An additional feature of the present invention is the inclusion of a marking pattern 18 in the form of a premeasured scale inscribed along the length of the shaft 12. Such a scale provides the surgeon with a means for determining the precise distance from the insertion hole in a vessel wall to either tip of the probe.
  • the marking pattern 18 extends the full length of the shaft 12 from bulbous tip 14 to bulbous tip 16.
  • FIG. 2 shows a partial, enlarged, side cut-away view of the vascular probe of the present invention.
  • This view illustrates the base 20 of the bulb 14 and stem 12.
  • This base 20 may be acrylic or other flexible material, but one of radiopaque material such as titanium, nickel, or any precious metal may be preferred for some applications.
  • a coating such as polyurethane plastic coating 22 provides a smooth, biocompatible surface over the entire probe 10.
  • An example of the preferred coating material is Estane ® Polymer, available from the thermoplastics group of BF Goodrich's Specialty Polymers and Chemical Division, located in Brecksville, Ohio.
  • the Estane ® is particularly desirable for this application, since it has a tensile strength rated at 7300 psi and a Shore hardness of 46D.
  • FIGS 3A, 3B and 3C depict various placements of the vascular probe within a vessel.
  • the surgeon grasps the vascular probe 10 along the shaft 12 and inserts the bulb (14 or 16) of choice through an incision 24 that has been prepared in a vessel wall 26.
  • the appropriate bulb size is selected on the basis of the internal diameter of the host vessel.
  • the bulb is urged forward along the interior lumen of the vessel 26.
  • the shaft 12 is advanced within the vessel lumen until it encounters the resistance of an occlusion 28.
  • Reference to the scale 18 on the shaft 12 gives an indication of the precise distance between the occlusion 26 and the incision 24. It can further be used to determine that a newly formed anastomosis of a bypass vessel 30 is, in fact, distal to the occlusion 28.
  • the probe 10 can also be used as either a stent or a retractor, as shown in Figure 3B.
  • its bulb 14 may be manipulated to assist in suturing a graft, such as vessel 30, to ensure proper attachment. Flexion of the shaft 12 causes the bulb 14 to exert pressure on the wall of vessel 26. This pressure alters the conformation of the incision 24 by pulling at its edges.
  • the vessel 30, such as the saphenous vein, is then more easily matched to the incision in the vessel 26, such as the coronary artery.
  • Suture material 32 is looped through the adjoining edges of vessels 26 and 30 and pulled taut.
  • Figure 3C depicts the positioning of the probe 10 just prior to completion of the anastomosis and withdrawal of shaft 12 and bulb 14 from the incision 24 in vessel 26 at the point of junction with vessel 30.
  • easy withdrawal of the bulb 14 from the vessel 26 indicates that the distal anastomic lumen is of an appropriate dimension.
  • Double armed suture material 32 is used to close the remainder of the anastomosis after the bulb 14 is withdrawn.
  • the bulbs on the probe 10 can be used as vessel occluders. When a sufficiently sized bulb is placed upstream to a surgical site (not shown) , it may totally occlude the lumen of the vessel and thus allow maintenance of a dry surgical field.
  • the vascular probe of the present invention may be used for a variety of broad applications, such as vessel occlusion, measurement and retraction, in addition to its utility as a probe.

Landscapes

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

Abstract

Sonde vasculaire (10) se composant d'une tige flexible (12) et de deux embouts (14, 16) en forme de bulbe placés à chaque extrémité de la tige. Dans un premier mode de réalisation, le dispositif proposé est une sonde vasculaire-rétracteur. Cette sonde vasculaire-rétracteur peut être inséré dans le système vasculaire par des chirurgiens en cardiologie vasculaire lors d'une opération chirurgicale cardiovasculaire. Cette sonde est utilisée afin de calibrer des vaisseaux sanguins, de bloquer la circulation du sang dans les vaisseaux sanguins, et d'identifier les lésions dues à une sténose et éloignées du site d'une anastomose. Le dispositif est constitué d'une tige en acrylique, jetable, recouverte d'un polyuréthane souple comportant à chaque extrémité un bulbe fermé et calibré. On peut également utiliser d'autres matières de base telles que du métal opaque aux radiations. Ce revêtement tel que du polyuréthane est utilisé afin de réduire la friction au contact de la paroi du vaisseau. Ladite tige se trouve avec différentes tailles d'embouts.
PCT/US1992/000800 1991-04-30 1992-01-31 Sonde vasculaire WO1992019161A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US69334591A 1991-04-30 1991-04-30
US693,345 1991-04-30

Publications (1)

Publication Number Publication Date
WO1992019161A1 true WO1992019161A1 (fr) 1992-11-12

Family

ID=24784274

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1992/000800 WO1992019161A1 (fr) 1991-04-30 1992-01-31 Sonde vasculaire

Country Status (1)

Country Link
WO (1) WO1992019161A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996039077A1 (fr) * 1995-06-06 1996-12-12 Corvita Corporation Appareil de mesure endovasculaire, moyen de chargement et de deploiement
WO1999023955A1 (fr) 1997-11-12 1999-05-20 Robert Lazzara Dispositif de pontage vasculaire
WO2003022169A1 (fr) * 2001-09-12 2003-03-20 Scimed Life Systems, Inc. Systeme d'identification de dispositifs medicaux
JP5937729B1 (ja) * 2015-08-05 2016-06-22 メドフォースジャパン株式会社 医療用消息子の製造方法
CN109044468A (zh) * 2018-09-18 2018-12-21 南京思脉德医疗科技有限公司 一种血管封堵器用封血塞结构
JP6469814B1 (ja) * 2017-10-27 2019-02-13 メドフォースジャパン株式会社 血管縫合用内腔維持カテーテル

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3938504A (en) * 1974-10-30 1976-02-17 Dickinson Ben Wade O Iii Method for measuring vagina dimensions

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3938504A (en) * 1974-10-30 1976-02-17 Dickinson Ben Wade O Iii Method for measuring vagina dimensions

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1996039077A1 (fr) * 1995-06-06 1996-12-12 Corvita Corporation Appareil de mesure endovasculaire, moyen de chargement et de deploiement
US6273895B1 (en) 1995-06-06 2001-08-14 Corvita Corporation Method of measuring a body cavity
WO1999023955A1 (fr) 1997-11-12 1999-05-20 Robert Lazzara Dispositif de pontage vasculaire
WO2003022169A1 (fr) * 2001-09-12 2003-03-20 Scimed Life Systems, Inc. Systeme d'identification de dispositifs medicaux
JP5937729B1 (ja) * 2015-08-05 2016-06-22 メドフォースジャパン株式会社 医療用消息子の製造方法
JP6469814B1 (ja) * 2017-10-27 2019-02-13 メドフォースジャパン株式会社 血管縫合用内腔維持カテーテル
WO2019082573A1 (fr) * 2017-10-27 2019-05-02 メドフォースジャパン株式会社 Cathéter de maintien de lumière pour suturer un vaisseau sanguin
JP2019076639A (ja) * 2017-10-27 2019-05-23 メドフォースジャパン株式会社 血管縫合用内腔維持カテーテル
US11224431B2 (en) 2017-10-27 2022-01-18 Medforce Japan Co., Ltd. Lumen maintaining catheter for suturing blood vessel
CN109044468A (zh) * 2018-09-18 2018-12-21 南京思脉德医疗科技有限公司 一种血管封堵器用封血塞结构

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