EP0951252A2 - Procedes et appareil de greffe medicale - Google Patents

Procedes et appareil de greffe medicale

Info

Publication number
EP0951252A2
EP0951252A2 EP97945625A EP97945625A EP0951252A2 EP 0951252 A2 EP0951252 A2 EP 0951252A2 EP 97945625 A EP97945625 A EP 97945625A EP 97945625 A EP97945625 A EP 97945625A EP 0951252 A2 EP0951252 A2 EP 0951252A2
Authority
EP
European Patent Office
Prior art keywords
apparatus defined
aperture
tubular body
distal portion
longitudinal
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
EP97945625A
Other languages
German (de)
English (en)
Inventor
Daniel J. Sullivan
Thomas J. Bachinski
David S. Goldsteen
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.)
St Jude Medical ATG Inc
Original Assignee
Vascular Science 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
Priority claimed from US08/745,618 external-priority patent/US5976178A/en
Priority claimed from US08/844,992 external-priority patent/US6120432A/en
Application filed by Vascular Science Inc filed Critical Vascular Science Inc
Publication of EP0951252A2 publication Critical patent/EP0951252A2/fr
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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/07—Stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32056—Surgical snare instruments
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2/064—Blood vessels with special features to facilitate anastomotic coupling
    • 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
    • A61F2/954—Instruments specially adapted for placement or removal of stents or stent-grafts for placing stents or stent-grafts in a bifurcation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
    • A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
    • A61B2017/003—Steerable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
    • A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28—Surgical forceps
    • A61B17/29—Forceps for use in minimally invasive surgery
    • A61B2017/2926—Details of heads or jaws
    • A61B2017/2932—Transmission of forces to jaw members
    • A61B2017/2939—Details of linkages or pivot points
    • 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
    • A61B90/30—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
    • A61B2090/306—Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure using optical fibres
    • 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
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A61B2090/3614—Image-producing devices, e.g. surgical cameras using optical fibre
    • 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
    • A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • 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
    • 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • A61F2002/065—Y-shaped blood vessels
    • 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
    • A61F2002/826—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0067—Three-dimensional shapes conical
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M2025/0213—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body
    • A61M2025/0233—Holding devices, e.g. on the body where the catheter is attached by means specifically adapted to a part of the human body specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible

Definitions

  • This invention relates to medical grafting methods and apparatus, and more particularly to methods and apparatus for installing tubular bypass grafts intralumenally.
  • Goldsteen et al. U.S. patent application No. 08/745,618, filed November 7, 1996 shows, among other things, methods and apparatus for installing tubular bypass grafts mtralumenally.
  • the Goldsteen et al. reference is hereby incorporated by reference herein m its entirety.
  • the Goldsteen et ai. reference shows methods and apparatus m which each end of the graft site is approached separately and mtralumenally, penetrated, and then a longitudinal structure (e.g., element 150 in the Goldsteen et al. reference) is established between the ends of the graft site.
  • This longitudinal structure may extend mtralumenally all the way out of the patient's body from both ends of the graft site.
  • the graft is fed into the patient's body mtralumenally along the longitudinal structure until it is in the desired position extending from one end of the graft site to the other. Each end of the graft is then secured at respective end of the graft site and the longitudinal structure is withdrawn from the patient.
  • FIG. 1 is a simplified sectional view showing a portion of an illustrative procedure and related apparatus in accordance with this invention.
  • FIG. 2 is a simplified longitudinal sectional view of an illustrative embodiment of a portion of the FIG. 1 apparatus in more detail.
  • FIG. 3 is a simplified elevational view of a portion of the FIG. 2 apparatus, but with the depicted elements in a different physical relationship to one another .
  • FIG. 4 is a simplified longitudinal sectional view of an alternative embodiment of one component of the FIG. 2 apparatus.
  • FIG. 5 is a simplified longitudinal sectional view of an alternative embodiment of another component of the FIG. 2 apparatus.
  • FIG. 6 is a simplified elevational view of another alternative embodiment of the component shown in FIG. 5.
  • FIG. 7 is a simplified elevational view of an alternative embodiment of still another component shown in FIG. 2.
  • FIG. 8 is a simplified elevational view of an alternative embodiment of yet another component shown in FIG. 2.
  • FIG. 9 is a simplified longitudinal sectional view similar to a portion of FIG. 1 showing a later stage in the illustrative procedure depicted in part by FIG. 1.
  • FIG. 10 is a simplified sectional view of the apparatus shown in FIG. 9 without the associated tissue structure being present.
  • FIG. 11 is a simplified cross sectional view of an illustrative embodiment of further illustrative apparatus in accordance with this invention.
  • FIG. 12 is a view similar to FIG. 1 showing an even later stage in the illustrative procedure depicted in part by FIG. 9, together with related apparatus, all in accordance with this invention.
  • FIG. 13 is a view similar to FIG. 12 showing a still later stage in the illustrative procedure depicted in part by FIG. 12.
  • FIG. 13a is a simplified elevational view of an illustrative embodiment of structural details that can be included in apparatus of the type shown in FIGS. 11-13.
  • FIG. 14 is a view similar to FIG. 13 showing an even later stage in the illustrative procedure depicted in part by FIG. 13.
  • FIG. 15 is a simplified longitudinal sectional view of an illustrative embodiment of a portion of still further illustrative apparatus in accordance with this invention.
  • FIG. 15a is a simplified elevational view of a structure which can be used to provide part of the apparatus shown in FIG. 15.
  • FIG. 15b is a view similar to FIG. 15a showing more of the structure of which FIG. 15a is a part.
  • FIG. 15c is a view similar to FIG. 15b showing the FIG. 15b structure in another operational condition.
  • FIG. 15d is a simplified elevational view of an alternative structure which can be used to provide part of the apparatus shown in FIG. 15.
  • FIG. 15e is a view similar to FIG. 15d showing the FIG. 15d structure in another operational condition.
  • FIG. 15f is a simplified longitudinal sectional view of another alternative structure which can be used to provide part of the apparatus shown in FIG. 15.
  • FIG. 15g is a view similar to FIG. 15f showing the FIG. 15f structure in another operational condition.
  • FIG. 16 is a simplified elevational view of an illustrative embodiment of one component of the FIG. 15 apparatus.
  • FIG. 17 is a simplified longitudinal sectional view of an illustrative embodiment of another portion of the FIG. 15 apparatus.
  • FIG. 18 is a view similar to a portion of
  • FIG. 14 showing an even later stage in the illustrative procedure depicted in part by FIG. 14.
  • FIG. 19 is a view similar to FIG. 18 showing a still later stage in the FIG. 18 procedure.
  • FIG. 20 is a view similar to FIG. 19 showing an even later stage in the FIG. 19 procedure.
  • FIG. 21 is a view similar to another portion of FIG. 14 showing a still later stage in the FIG. 20 procedure .
  • FIG. 22 is a view similar to FIG. 21 showing an even later stage in the FIG. 21 procedure.
  • FIG. 22a is a view similar to FIG. 22 showing a still later stage in the FIG. 22 procedure.
  • FIG. 22b is a view similar to FIG. 22a showing an even later stage in the FIG. 22a procedure.
  • FIG. 23 is a view similar to FIG. 22b showing a still later stage in the FIG. 22b procedure.
  • FIG. 24 is a view similar to FIG. 23 showing an even later stage in the FIG. 23 procedure.
  • FIG. 25 is a simplified longitudinal sectional view of an illustrative embodiment of a portion of more apparatus in accordance with this invention.
  • FIG. 26 is a view similar to FIG. 20 showing a later stage in the FIG. 24 procedure.
  • FIG. 27 is a view similar to FIG. 26 showing a still later stage in the FIG. 26 procedure.
  • FIG. 28 is a view similar to FIG. 24 showing an even later stage in the FIG. 27 procedure.
  • FIG. 29 is a view similar to FIG. 28 showing a still later stage in the FIG. 28 procedure.
  • FIG. 30 is a view similar to FIG. 29 showing an even later stage in the FIG. 29 procedure.
  • FIG. 31 is a view similar to FIG. 14 showing the end result of the procedure depicted in part by FIG. 30.
  • FIG. 32 is a simplified longitudinal sectional view showing an end result similar to FIG. 31 but in a different context.
  • FIG. 33 is a simplified longitudinal sectional view showing a possible alternative construction of portions of the apparatus showing in FIG. 15.
  • FIG. 34 is a simplified elevational view (partly in section) showing another possible alternative construction of portions of the FIG. 15 apparatus .
  • FIG. 35 is a simplified longitudinal sectional view of the FIG. 34 apparatus in another operating condition.
  • FIG. 36 is a simplified elevational view of apparatus which can be used as an alternative to certain apparatus components shown in FIGS. 15 and 17.
  • FIG. 37 is a simplified elevational view (partly in section) showing additional components with the FIG. 36 apparatus.
  • FIG. 38 is a simplified longitudinal sectional view showing still another possible alternative construction of portions of the FIG. 15 apparatus .
  • FIG. 39 is a simplified elevational view showing in more detail a possible construction of a portion of the FIG. 38 apparatus.
  • FIG. 40 is a simplified elevational view of illustrative apparatus that can be used as an alternative to certain apparatus shown in other FIGS.
  • FIG. 1 shows a patient's aorta 30 with a coronary artery 20 branching off from the aorta.
  • a narrowing 22 in coronary artery 20 is obstructing blood flow from aorta 30 to downstream portions of the coronary artery, thereby preventing the patient's heart from receiving all the blood it needs for normal operation.
  • a bypass graft around narrowing 22 is needed, and one way to provide such a bypass is to add a graft conduit from aorta 30 (e.g., at location 34) to a downstream portion of coronary artery 20 (e.g., at location 24) .
  • elongated instrumentation 200 is introduced into the patient's circulatory system, preferably from a location remote from aorta 30.
  • instrumentation 200 may be introduced into the patient's circulatory system from a femoral artery, a brachial artery, or any other suitable location.
  • instrumentation 200 passes intralumenally along the patient's circulatory system until a distal portion 204 of instrumentation 200 is adjacent one end (e.g., 34) of the desired graft site.
  • Undepicted proximal portions of instrumentation 200 always remain outside the patient adjacent the point of introduction of the instrumentation so that the physician (a term which includes any technicians or other assistants) can control the instrumentation from outside the patient's body.
  • the depicted distal portions of instrumentation 200 are controlled remotely by the physician from outside the patient. Radiologic markers such as 206 may be provided on instrumentation 200 to aid the physician in properly locating the instrumentation in the patient.
  • FIG. 2 An illustrative construction of instrumentation 200 is shown in more detail in FIG. 2.
  • This FIG. shows the distal portions of elements 220, 230, 240, and 250 telescoped out from one another and from the distal end of outer member 210 for greater clarity. It will be understood, however, that all of these elements are initially inside of one another and inside outer member 210. Indeed, member 210 may be initially positioned in the patient without any or all of elements 220, 230, 240, and 250 inside, and these elements may then be inserted into member 210. Moreover, the number of members like 220, 230, etc., may be more or less than the number shown in FIG. 2, depending on the requirements of a particular procedure .
  • Outer member 210 may be a catheter-type member.
  • the distal portion of catheter 210 may carry two axially spaced annular balloons 212 and 214.
  • Proximal balloon 212 is inflatable and deflatable via inflation lumen 216 in catheter 210.
  • Distal balloon 214 is inflatable and deflatable via inflation lumen 218 in catheter 210.
  • Lumens 216 and 218 are separate from one another so that balloons 212 and 214 can be separately controlled.
  • Balloons 212 and 214 are shown substantially deflated in FIG. 2.
  • the distal end of catheter 210 may be tapered as shown at 211 in FIG. 4 to facilitate passage of catheter 210 through an aperture in aorta 30 as will be described below.
  • Sheath 220 is longitudinally movable relative to catheter 210.
  • the distal portion of sheath 220 may be tapered as shown at 222 in FIG. 5, and/or externally threaded as shown at 224 in FIG. 6.
  • Either or both of features 222 and 224 may be provided to facilitate passage of sheath 220 through an aperture in aorta 30 as will be described below. If threads 224 are provided, then sheath 220 is rotatable (either alone or with other components) about the longitudinal axis of instrument 200 in order to enable threads 224 to engage the tissue of the aorta wall and help pull sheath 220 through the aorta wall.
  • Tube 230 is longitudinally movable relative to sheath 220.
  • Tube 230 may also be rotatable (about the central longitudinal axis of instrument 200) relative to sheath 220, and the distal end of tube 230 may be threaded on the outside (as shown at 232 in FIG. 7) for reasons similar to those for which threading 224 may be provided on sheath 220.
  • Tube 230 is preferably controllable from its proximal portion (outside the patient) to deflect laterally by a desired amount to help steer, push, or twist instrument 200 to the desired location in the patient. Examples of illustrative steering techniques are discussed in more detail below in connection with FIGS. 11-13.
  • Coaxially inside tube 230 is tube 240.
  • Tube 240 is longitudinally movable relative to tube 230, and may be metal (e.g., stainless steel) hypotube, for example.
  • Screw head 242 is mounted on the distal end of tube 240 and is threaded (as indicated at 244) on its distal conical surface.
  • Tube 240 is rotatable (about the central longitudinal axis of instrument 200, either alone or with other elements) in order rotate head 242 and thereby use threads 244 in engagement with the tissue of the aorta wall to help pull head 242 through that wall as will be more fully described below. Because tube 240 is hollow, it can be used for passage of fluid or pressure into or out of the patient.
  • longitudinal structure 250 Coaxially inside tube 240 is longitudinal structure 250.
  • Longitudinal structure 250 is longitudinally movable relative to tube 240.
  • Structure 250 may also be rotatable (about its longitudinal axis) relative to tube 240 and/or other elements.
  • Structure 250 may be a wire with a distal end portion 252 that is resiliently biased to deflect laterally to one side. Wire portion 252 is kept relatively straight when it is inside tube 240 as shown in FIG. 2. But when wire portion 252 is pushed axially out the distal end of tube 240, it curves to one side as shown in FIG. 3.
  • the distal portion of structure 250 may be threaded as shown at 254 in FIG. 8 to help structure 250 thread its way through the wall of aorta 30.
  • All of components 210, 220, 230, 240, and 250 are controlled from outside the patient's body as is described in general terms above.
  • proximal balloon 212 When the distal portion of catheter 210 is at the desired location 34, proximal balloon 212 is inflated. Even when inflated, proximal balloon 212 is not large enough to block aorta 30.
  • wire 250 is pushed distally so that its distal portion emerges from the distal end of tube 240 and penetrates the wall of aorta 30 at location 34. This anchors the distal portion of instrument 200 to the aorta wall at the desired location. Because of its operation to thus anchor instrument 200, wire 250 is sometimes referred to as an anchor wire.
  • the rotatability of wire 250, as well as its resilient lateral deflection (FIG. 3) and/or threads 254 (FIG. 8), may be used to help get the distal end of the wire to the desired location 34 and firmly into the aorta wall at that location in order to achieve the desired anchoring of instrument 200.
  • tubes 230 and 240 are moved in the distal direction relative to wire 250 so that screw head 242 begins to follow wire 250 into and through the aorta wall.
  • at least tube 240 is rotated about its longitudinal axis so that threads 244 help to pull head 242 into and through the aorta wall.
  • the distal portion of tube 230 follows head 242 through the aorta wall. If provided, threads 232 and rotation of tube 230 may facilitate transfer of the aorta wall tissue from head 242 to tube 230.
  • sheath 220 When tube 230 is through the aorta wall, sheath 220 is moved distally relative to tube 230 so that a distal portion of sheath 220 follows tube 230 through the aorta wall. If provided, the distal taper 222 and/or threads 224 and rotation of sheath 220 help the distal portion of sheath 220 through the aorta wall. Then catheter 210 is advanced distally relative to sheath 220 so that a distal portion of catheter 210 follows sheath 220 through the aorta wall. Again, the distal taper 211 of catheter 210 (if provided) helps the distal portion of the catheter through the aorta wall.
  • Inflated proximal balloon 212 prevents more than just the portion of catheter 210 that is distal of balloon 212 from passing through the aorta wall. It should be mentioned that each time another, larger one of elements 240, 230, 220, and 210 is pushed through the aorta wall, the previously extended elements can be and preferably are either held stationary or pulled back proximally to prevent them from damaging body tissues outside the aorta. It should also be mentioned that threading such as 254, 244, 232, and 224 is entirely optional and can be omitted if the associated elements are made sharp enough and can be pushed distally sufficiently strongly to penetrate the aorta wall without the aid of threading and rotation.
  • distal balloon 214 When the distal portion of catheter 210 is through the aorta wall, distal balloon 214, which is now outside the aorta, is also inflated.
  • the axial spacing between balloons 212 and 214 is preferably small enough so that the aorta wall is clamped between these two balloons as shown in FIG. 9.
  • balloons 212 and 214 were inflated without the presence of the aorta wall, their appearance might be as shown in FIG. 10.
  • the close spacing of balloons 212 and 214, as well as their resilient bias toward one another, helps to anchor catheter 210 through the aorta wall and also to seal the aorta wall around the catheter.
  • Balloons 212 and 214 may be inflated by liquid or gas, and they may be specially coated to help improve the seal between catheter 210 and the aorta wall.
  • FIG. 11 A simplified cross sectional view of an illustrative steerable endoscopic instrument 300 is shown in FIG. 11.
  • instrument 300 includes one or more sheath structures such as 310a and 310b that are operable by the physician to steer the instrument by curvilinearly deflecting it laterally by a desired, variable amount.
  • sheath structures such as 310a and 310b that are operable by the physician to steer the instrument by curvilinearly deflecting it laterally by a desired, variable amount.
  • any other conventional steering elements may be provided and used.
  • Other examples of suitable steering structures are shown in Bachinski et al. U.S. patent application No.
  • a fiber optic bundle 320 for conveying light from outside the patient to the distal end of instrument 300 in order to provide illumination beyond the distal end of the instrument
  • another fiber optic bundle 330 for conveying an image from beyond the distal end of the instrument back to optical and/or video equipment outside the patient and usable by the physician to see what is beyond the distal end of the instrument
  • a lumen 340 with a longitudinal structure 150 i.e., a wire
  • Additional lumens such as 360 may be provided for such purposes as (1) introducing fluid that may help to clear the distal ends of fiber optic bundles 320 and 330, (2) introducing fluid for irrigating and/or medicating the patient, (3) suctioning fluid from the patient, etc.
  • the distal portion of steerable endoscopic instrument 300 is extended distally beyond the distal end of catheter 210 and steered by the physician until it is adjacent to the exterior of coronary artery portion 24.
  • the endoscopic features of instrument 300 are used by the physician to help steer the distal end of the instrument to the desired location.
  • Instrument 300 may also be provided with radiologic markers (like markers 206 on instrument 200 in FIG. 1) to additionally help the physician get the distal end of instrument 300 to the desired location.
  • the next step in the illustrative procedure being described is to extend longitudinal structure 150 from the distal end of instrument 300 so that it passes through the wall of coronary artery 20 at location 24 and into the lumen of the artery as shown in FIG. 13.
  • the distal end of longitudinal structure 150 may be sharply pointed.
  • the distal portion of longitudinal structure 150 may also be threaded (analogous to the threads 254 shown on the distal portion of longitudinal structure 250 in FIG. 8) and longitudinal structure 150 may be rotated about its longitudinal axis so that the threads engage the coronary artery wall tissue and pull longitudinal structure 150 into and through the coronary artery wall.
  • the distal portion of longitudinal structure 150 is preferably pushed sufficiently far down into the lumen of coronary artery 20 so that it does not inadvertently come out of the coronary artery.
  • FIG. 13a shows alternative apparatus that may be used to introduce the distal portion of longitudinal structure 150 into coronary artery 20 at location 24.
  • This apparatus includes a hypotube 370 that extends distally from the distal end of instrument 300.
  • Hypotube 370 may have a fixed amount of extension from instrument 300, or it may be selectively extendable from instrument 300. Hypotube 370 has a sharply pointed distal tip portion 372, the purpose of which will be described below. An illustrative size for hypotube 370 is about 0.015 inches in diameter.
  • Longitudinal structure 150 is disposed coaxially inside hypotube 370 and is axially and rotatably movable relative to hypotube 370.
  • the proximal portion 150a of structure 150 may be a wire having a diameter of about 0.009 inches.
  • a distal portion 150b of wire 150a may be ground down to produce a safety ribbon inside wire coil 150c.
  • An illustrative size for the wire of coil 150c is about 2 mils.
  • the proximal end of coil wire 150c is secured to wire 150a.
  • the distal end of coil wire 150c is secured to distal tip 150d, which is also secured to the distal end of safety ribbon 150b.
  • Elements 150b, 150c, and 150d cooperate to give longitudinal structure 150 a highly flexible distal portion.
  • the distal portion of longitudinal structure 150 may be distally extended from the distal portion of hypotube 370. This protects cutter tip 372 and also protects nearby tissue from the cutter tip.
  • Instrument 300 is controlled as described above in connection with FIG. 12 to position cutter tip 372 adjacent coronary artery portion 24. Longitudinal structure 150 is then retracted proximally to expose cutter tip 372. Next, cutter tip 372 is advanced to make a slit through coronary artery portion 24. With cutter tip 372 still in this slit, longitudinal structure 150 is moved distally relative to hypotube 370 so that the distal portion of structure 150 passes through the above-mentioned slit into the lumen of coronary artery 20. Once inside the coronary artery lumen, the distal portion of longitudinal structure 150 can be pushed farther down along that lumen.
  • Wire coil 150c can be used to threadedly engage the interior of the coronary artery where the coronary artery narrows down (farther along its length) to help releasably anchor the distal portion of structure 150 in the coronary artery.
  • This threaded engagement can be produced by rotating longitudinal structure 150 about its longitudinal axis when the longitudinal structure begins to encounter resistance to further distal pushing along the coronary artery.
  • this threaded engagement is reversible by rotating longitudinal structure 150 in the direction opposite to the direction which produces the threaded engagement.
  • the next step is to withdraw instrument 300 (including hypotube 370 if provided) from the patient by pulling instrument 300 back out through catheter 210.
  • instrument 300 including hypotube 370 if provided
  • Only longitudinal structure 150 from instrument 300 is left in the patient as shown in FIG. 14.
  • longitudinal structure 150 may be provided with radiologic markers 154 equally spaced along the length of its distal portion to help the physician determine by radiologic observation the actual length between location 24 and location 34. This enables the physician to determine the exact length of the graft tubing needed to connect locations 24 and 34.
  • the next phase of the illustrative procedure being described is to install a new length of tubing between regions 24 and 34.
  • the new length of tubing may be either an artificial graft, natural body organ tubing harvested from the patient's body, or a combination of artificial and natural tubing (e.g., natural tubing coaxially inside artificial tubing) .
  • the new tubing is to be natural tubing (e.g., a length of the patient's saphenous vein that has been harvested for this purpose) inside an artificial conduit.
  • both conduits can be delivered and installed simultaneously, or the outer artificial conduit can be delivered and installed first, and then the inner - I i
  • catheter 210 and longitudinal structure 150 (hereinafter referred to for convenience and simplicity of terminology as wire 150) to deliver an artificial conduit so that it extends between regions 24 and 34.
  • wire 150 The distal portion of an illustrative assembly 400 for doing this is shown in FIG. 15. (Several alternative constructions of this portion of the apparatus are shown in later FIGS, and described below.)
  • assembly 400 includes a threaded, conical, distal tip 412 mounted on a tubular member 410 (e.g., metal hypotube) through which wire 150 can freely pass. Additional details regarding various possible constructions of tip 412 are provided later with reference to FIGS. 15a-15g, but it should be mentioned here that in this embodiment tip 412 is selectively collapsible to facilitate its withdrawal from the patient after it has served its purpose.
  • a tubular member 410 e.g., metal hypotube
  • Another tubular member 420 is disposed concentrically around tubular member 410.
  • An inflatable balloon 422 is mounted on the distal end of tubular member 420.
  • Tubular member 420 includes an axially extending lumen (not shown in FIG. 15) for use in selectively inflating and deflating balloon 422. Balloon 422 is shown deflated in FIG. 15. Coaxially around tubular member 420 is an artificial graft conduit 430.
  • An illustrative embodiment of a suitable conduit 430 is shown in FIG. 16 and includes a tube formed of a frame 432 of a first highly elastic material (such as nitinol) with a covering 434 of a second highly elastic material (e.g., a rubber-like material such as silicone) substantially filling the apertures in the frame. Additional information regarding this possible embodiment of conduit 430 and other suitable artificial graft structures is provided in the Goldsteen et al .
  • this structure is extremely elastic, flexible, pliable, and resilient. For example, it can be stretched to a small fraction of its original diameter, and it thereafter returns by itself to its original size and shape without damage or permanent deformation of any kind.
  • this structure is distensible so that it may pulsate very much like natural circulatory system tubing in response to pressure waves in the blood flow. This helps keep the conduit open, especially if it is used by itself as the final graft conduit.
  • FIG. 17 shows how hooks 436 and flaps 438 are compressed radially inwardly and confined within conduit delivery tube 440, which coaxially surrounds conduit 430.
  • conduit 430 may be somewhat circumferentially compressed by tube 440.
  • FIG. 17 shows how flaps 438 are confined within conduit delivery tube 440.
  • FIG. 17 also shows how tubes 410, 420, and 440 extend proximally (to the right as viewed in FIG. 17) from the proximal end of conduit 430 so that the physician can remotely control the distal portion of assembly 400 from outside the patient.
  • assembly 400 is fed into the patient along wire 150 through catheter 210.
  • tip 412 reaches coronary artery portion 24, tip 412 is threaded into and through the coronary artery wall by rotating tube 410 and therefore tip 412.
  • the passage of tip 412 through the coronary artery wall opens up the aperture previously made by wire 150 in that wall. After tip 412 passes through the artery wall, that wall seals itself against the outside of the distal portion of conduit delivery tube 440 as shown in FIG. 18.
  • Conduit 430 is initially moved distally with components 410 and 412. This may be done by inflating balloon 422 so that it engages conduit 430, and then moving tube 420 distally with components 410 and 412. Distal motion of conduit 430 moves hooks 436 beyond the distal end of delivery tube 440, thereby allowing the hooks to spring out inside coronary artery 20 as shown in FIG. 19. This prevents the distal end of conduit 430 from being pulled proximally out of the coronary artery. If balloon 422 was inflated during this phase " of the procedure, it may be deflated before beginning the next phase.
  • the next step is to pull delivery tube 440 back slightly so that it is withdrawn from coronary artery 20. Then tube 420 is moved distally so that balloon 422 is radially inside the annulus of hooks 436. Balloon 442 is then inflated to ensure that hooks 436 are firmly set in coronary artery 20. Conditions are now as shown in FIG. 20. Cross sections of balloon 422 may be L-shaped when inflated (one leg of the L extending parallel to the longitudinal axis of conduit 430, and the other leg of the L extending radially outward from that longitudinal axis immediately distal of hooks 436) . This may further help to ensure that hooks 436 fully engage the wall of coronary artery 20. The next step is to deflate balloon 422.
  • delivery tube 440 is withdrawn proximally until flap 438a (but not flap 438b) is distal of the distal end of the delivery tube. This allows flap 438a to spring radially out as shown in FIG. 21. Tube 420 is then withdrawn until balloon 422 is just distal of flap 438a. Then balloon 422 is inflated, producing the condition shown in FIG. 21.
  • next steps are (1) to deflate distal balloon 214, (2) to proximally withdraw catheter 210 a short way, (3) to proximally withdraw tube 420 to press flap 438a against the outer surface of the aorta wall, and (4) to proximally withdraw delivery tube 440 by the amount required to allow flap 438b to spring out against the interior of catheter 210, all as shown in FIG. 22.
  • the hooks or barbs 439 on flap 438a are urged to enter the aorta wall tissue to help maintain engagement between flap 438a and the wall of the aorta.
  • Inflated bal oon 422 helps to set hooks or barbs 439 in the tissue when tube 420 is tugged proximally.
  • the next step is to insert the distal portion of delivery tube 440 into the proximal end of conduit 430 as shown in FIG. 22a.
  • the distal end of conduit 440 may be inserted all the way to the proximal end of balloon 422 (see FIG. 23 for a depiction of this) .
  • a purpose of this step is to subsequently help control the rate at which blood is allowed to begin to flow through conduit 430.
  • the next step is to proximally withdraw catheter 210 by the amount required to release flap 438b to spring out against the interior of the wall of aorta 30 as shown in FIG. 22b.
  • Catheter 210 may be subsequently pushed back against flap 438b as shown in FIG. 23 to help securely engage that flap against the aorta wall.
  • FIGS. 15a-15g Several illustrative embodiments of collapsible tips 412 are shown in FIGS. 15a-15g.
  • a frame of wire struts 412a extends radially out and proximally back from the distal end of hypotube 410 (see especially FIG. 15a) .
  • This frame is covered with a somewhat elastic polymer cover 412b (FIG. 15b) which is provided with threads as indicated at 412c.
  • threads 412c may be made of one or more spirals of nitinol wire or other metal.
  • another hypotube 410a (which is disposed around hypotube 410) is shifted distally relative to hypotube 410 to invert and collapse tip 412 as shown in FIG. 15c.
  • tip 412 has a central main portion 412e attached to hypotube 410.
  • main portion 412e Around the proximal portion of main portion 412e are a plurality of triangular shaped portions 412f, each of which is connected to main portion 412e by a hinge 412g.
  • the outer surface of the tip is threaded as indicated at 412h.
  • tip 412 may be made of a plastic polymer material, and hinges 412g may be so-called "living" hinges between the various masses of the polymer.
  • triangular portions 412f meet any resistance as tip 412 is withdrawn proximally, they pivot about their hinges 412g to the positions shown in FIG. 15e, thereby greatly reducing the circumferential size of the tip.
  • metal struts 412j are attached to the distal end of hypotube 410 so that they extend radially out and proximally back.
  • struts 412j are covered with a cover and threads like the cover 412b and threads 412c shown in FIG. 15b and described above.
  • a wire 412k connects a proximal portion of each strut 412j, through an aperture in hypotube 410, to the distal end of another hypotube 410b which is disposed inside hypotube 410. When wires 412k are relaxed as shown in FIG.
  • struts 412j extend radially out beyond the circumference of delivery tube 440.
  • hypotube 410b is pulled back proximally relative to hypotube 410 as shown in FIG. 15g. This causes wires 412k to pull struts 412j in so that the outer circumference of tip 412 is much smaller than the circumference of delivery tube 440.
  • natural body conduit e.g. a length of the patient's saphenous vein that has been harvested for this purpose
  • artificial conduit 430 After installation of the latter conduit.
  • An illustrative assembly 500 for delivering a length of natural body conduit to installed conduit 430 is shown in FIG. 25.
  • assembly 500 includes a tube 510 disposed around wire 150 so that tube 510 is freely movable in either direction along wire 150.
  • Tube 510 has an inflatable annular balloon 512a near its distal end and another inflatable annular balloon 512b spaced in the proximal direction from balloon 512a.
  • Tube 510 includes separate inflation lumens (not shown) for each of balloons 512 so that the balloons can be separately " inflated and deflated.
  • An annular collar structure or ring 520a is disposed concentrically around balloon 512a, and a similar annular collar structure or ring 520b is disposed concentrically around balloon 512b.
  • Balloons 512 may be partly inflated.
  • Each of rings 520 may have radially outwardly extending hooks or barbs 522.
  • a length of natural body conduit 530 (e.g., saphenous vein as mentioned earlier) extends from ring 520a to ring 520b around the intervening portion of tube 510. Hooks or barbs 522 may extend through the portions of conduit 530 that axially overlap rings 520.
  • a delivery tube 540 is disposed around conduit 530. In use, tubes 510 and 540 extend proximally (to the right as viewed in FIG. 25) out of the patient to permit the physician to remotely control the distal portion of assembly 500.
  • assembly 500 may include a spring coil (similar to coil 450 in FIG. 36) extending between rings 520 inside of conduit 530 to help hold conduit 530 open and out against delivery tube 540 or subsequently out against conduit 430.
  • balloons 512 may be both in the same tube 510, balloon 512a may be on a relatively small first tube, while balloon 512b is on a larger second tube that concentrically surrounds the proximal portion of the first tube.
  • the first and second tubes are axially movable relative to one another, thereby allowing the distance between balloons 512 to be adjusted for grafts 530 of different lengths. Illustrative apparatus of this kind is shown in Goldsteen et al .
  • Assembly 500 is employed by placing it on wire 150 leading into catheter 210. Assembly 500 is then advanced distally along wire 150 through catheter 210 and then into conduit 430 until the distal end of conduit 530 is adjacent the distal end of conduit 430 and the proximal end of conduit 530 is adjacent the proximal end of conduit 430. The condition of the apparatus at the distal end of assembly 500 is now as shown in FIG. 26. The condition of the apparatus at the proximal end of conduit 530 is as shown in FIG. 28.
  • the next step is to proximally withdraw delivery tube 540 so that the distal portion of conduit 530 and distal barbed ring 520a are no longer inside the distal portion of delivery tube 540.
  • distal balloon 512a is inflated to circumferentially expand ring 520a and to set hooks or barbs 522 through conduit 530 into the surrounding portion of conduit 430 and coronary artery wall portion 24.
  • FIG. 27 shows the condition of the apparatus at this stage in the procedure.
  • the next step is to continue to proximally withdraw delivery tube 540 until the proximal end of conduit 530 and proximal ring 520b are no longer inside tube 540 (see FIG. 29) .
  • proximal balloon 512b is inflated to circumferentially expand ring 520b and thereby set hooks or barbs 522 through conduit 530 into the surrounding portion of conduit 430 and aorta wall portion 34 (see FIG. 30) .
  • This provides a completed anastomosis of the proximal end of conduit 530 to aorta 30.
  • the next step is to deflate balloons 512a and 512b and proximally withdraw tube 510 and delivery tube 540 from the patient via catheter 210.
  • wire 150 is withdrawn from the patient by pulling it proximally from catheter 210.
  • catheter 210 is proximally withdrawn from the patient to conclude the procedure.
  • the bypass that is left in the patient is as shown in FIG. 31.
  • This bypass extends from aorta 30 at location 34 to coronary artery 20 at location 24.
  • the bypass includes natural body conduit 530 inside artificial graft conduit 430.
  • One end of the bypass is anchored and anastomosed to coronary artery 20 by hooks 436 and ring 520a.
  • the other end of the bypass is anchored and anastomosed to aorta 30 by flaps 438 and ring 520b.
  • bypass 620 is a same-vessel bypass around a narrowing 612 in vessel 610.
  • the various components of bypass 620 are identified using the same reference numbers that are used for similar elements in FIG. 31.
  • the invention is also applicable to procedures similar to any of those mentioned above, but for non-circulatory systems such as urological tubing.
  • FIGS. 15-15g are illustrative of only one of several possible approaches to providing a structure that can penetrate the wall of coronary artery 20 from outside the artery.
  • FIG. 33 Another example of a suitable structure is shown in FIG. 33.
  • FIG. 33 uses reference numbers with primes for elements that are generally similar to elements identified by the corresponding unprimed reference numbers in FIG. 15.
  • distal tip 412' has external threads 414 for helping to grip and dilate tissue such as the wall of coronary artery 20 as tip 412' is rotated about wire 150 by rotation of proximally extending tubular shaft 410'.
  • Threads 414 continue as threads 442 on the exterior of the distal portion of tube 440'.
  • Threads 414 also threadedly engage with threads 444 on the interior of the distal portion of tube 440'.
  • structure 410' can be removed from structure 440' by rotating structure 410' in the direction relative to structure 440' that causes threads 414 and 444 to cooperate to shift tip 412' proximally relative to structure 440'.
  • elements 410' and 412' can be pulled proximally out of the patient.
  • Tube 440' which remains in place through the coronary artery wall, can thereafter be used as a guide tube for delivery of a graft structure (such as 430 (FIGS. 15-17)) and associated instrumentation (such as structure 420 (e.g., FIGS. 15 and 17)) to the operative site.
  • FIGS. 34 and 35 Another illustrative alternative embodiment of some of the instrumentation shown in FIG. 15 is shown in FIGS. 34 and 35.
  • FIGS. 34 and 35 use reference numbers with primes for elements that are generally similar to elements identified by the corresponding unprimed reference numbers in FIG. 15.
  • struts 436' are connected to the distal end of a serpentine ring 439 which is connected in turn to the distal end of frame 432'.
  • Struts 436' are initially held in the form of a distally pointed cone by yieldable bands 437a, 437b, 437c, and 437d.
  • bands 437 may be made of a polymeric or other suitable yieldable material. Alternatively, bands 437 could be serpentine metal members that yield by becoming straighter. Bands 437 are initially strong enough to prevent struts 436' from flaring radially outward from conduit 430' as the struts are resiliently biased to do. However, bands 437 can be made to yield by inflating balloon 422' (on the distal end of tube 420') inside the annulus of struts 436'. Struts 436' can be forced through tissue such as the wall of coronary artery 20 in their initial cone shape.
  • tube 420' may be metal (e.g., stainless steel) hypotube which can transmit pushing force to the cone of struts 436' by inflating balloon 422' to trap the base of the cone between balloon 422' and tube 440. Additional pushing force may then also be applied via tube 440 itself.
  • balloon 422' is inflated inside the cone as shown in FIG. 35 to cause bands 437 to yield.
  • Bands 437 may be made progressively weaker in the distal direction to facilitate prompt yielding of distal bands such as 437a and 437b in response to relatively little inflation of balloon 422', whereas more proximal bands such as 437c and 437d do not yield until somewhat later in response to greater inflation of balloon 422'. This progression of yielding may help ensure that the annulus of struts flares out in the desired trumpet-bell shape of hooks inside the coronary artery.
  • FIGS. 34 and 35 illustrate the point that if the structure used to enlarge the initial hole (made by wire 150) through the wall of coronary artery 20 is sufficiently sharp, it may not be necessary to provide threads on and rotation of the structure. Instead, the hole-enlarging structure can simply be pushed through the coronary artery wall. This same principle applies to all embodiments of structures for penetrating the coronary artery wall and subsequently enlarging the opening in that wall (e.g., as in FIGS. 13, 15-15g, 33, and 36-39) .
  • FIGS. 36 and 37 illustrate another possible use of a cone structure like that shown in FIGS. 34 and 35, as well as illustrating other possible aspects of the invention.
  • FIGS. illustrate a structure that can be used to deliver an artificial graft conduit, or a natural graft conduit, or both an artificial graft conduit and a natural graft conduit simultaneously (e.g., with the natural conduit coaxially mside the artificial conduit) .
  • FIGS. 36 and 37 it is assumed that only natural graft conduit is being delivered, but it will be readily apparent that artificial graft conduit could be substituted for or added outside the natural graft conduit .
  • the cone of struts 436' is mounted on the distal end of a highly elastic coil spring 450.
  • the proximal end of coil 450 is attached to ring 460.
  • the cone of barbs 436' is provided with additional, relatively short, radially outwardly projecting hooks or barbs 436" near the proximal base of the cone.
  • hooks or barbs 436" extend into and/or through the distal portion of a length of graft tubmg 530, which (as has been mentioned) is assumed m this case to be natural body organ tubmg such as saphenous vein.
  • Ring 460 is similarly provided with radially outwardly extending hooks or barbs 462 which extend into and/or through the proximal portion of graft conduit 530. Ring 460 also includes resilient radially outwardly extending annular flaps 438a and 438b with hooks or barbs 439, all similar to correspondingly numbered elements m FIG. 16.
  • Spring 450 which is mside conduit 530 between the cone of barbs 436' and ring 460, helps to support and hold open the graft conduit.
  • Structure 420' (similar to structure 420' m FIGS. 34 and 35 and including balloon 422' as shown m those FIGS.) is disposed around wire 150 mside structures
  • Delivery tube 440 is disposed around conduit 530.
  • FIGS. 36 and 37 illustrates a structure which can be used to deliver and install natural body organ conduit without any full length artificial graft conduit being used.
  • the structure shown in FIG. 37 is delivered to the operative site via wire 150.
  • the cone of struts 436' is forced through the wall of coronary artery 20 and then flared radially outward inside the coronary artery to anchor the distal end of the graft conduit to that artery.
  • the distal end of delivery tube 440 is pulled back as needed to aid in attachment of the distal end of the graft structure.
  • proximal end of the graft structure is performed similarly to what is shown in FIGS. 21-24. Accordingly, with distal flap 438a just outside the wall of aorta 30, delivery tube 440 is pulled back proximally to expose that flap. Flap 438a is thereby released to spring out and engage the outer surface of the aorta wall. After that has occurred, proximal flap 438b is adjacent the inner surface of the aorta wall. Tube 440 is pulled back proximally even farther to expose flap 438b so that it can spring out and engage the inner surface of the aorta wall. Natural body organ graft 530 is now fully installed in the patient. Structures 436', 450, and 460 remain in place in the patient to help anchor the ends of graft conduit 530 and to help hold open the medial portion of that conduit .
  • coil 450 is optional. If coil 450 is used, its ends may or may not be attached to structures 436 and/or 460.
  • a coil like coil 450 can be used in other embodiments of the invention.
  • a coil like 450 could be used between rings 520a and 520b in embodiments like that shown in FIG. 25 to help hold open graft conduit 530 in that embodiment.
  • FIG. 38 uses reference numbers with double primes for elements that are generally similar to elements identified by the corresponding unprimed reference numbers in FIG. 15.
  • the distal end of artificial graft conduit 430" is attached to expandable ring 430a.
  • Elongated struts 436" extend distally from the distal end of ring 430a. The distal ends of struts 436" are turned back in the proximal direction and extend just far enough into the distal end of tube 420" to be releasably retained by that tube.
  • Struts 436" are resiliently biased to extend radially outward from ring 430a, but are initially restrained from doing so by the presence of their distal end portions in the distal end of tube 420".
  • struts 436" initially form a distally pointing cone that can be pushed through tissue such as the wall of coronary artery 20 in the same manner that has been described above in connection with FIGS. 34- 37.
  • Structure 420 which may be metal (e.g., stainless steel) hypotube with an inflatable annular balloon 422" near its distal end, may be used to help push the cone through the tissue.
  • each of struts 436" may be twisted 180° as shown m FIG. 39 before it enters the distal end of tube 420".
  • Ring 430a and struts 436" may be made of any suitable material such as any 300-ser ⁇ es stainless steel (e.g., 316L stainless steel). Another material that may be suitable for struts 436" is nitinol. As previously described embodiments, the elastic cover 434 that forms part of conduit 430" preferably extends to regions 430a and 436".
  • a catheter into coronary artery 20 during the procedure described above that includes FIG. 1 and related FIGS, m order to medicate the coronary artery, to introduce radiologic (e.g., fluroscopic) liquids into the coronary artery, etc.
  • radiologic e.g., fluroscopic
  • FIG. 40 shows a structure 700 that may be used as an alternative to an inflatable balloon for radially enlarging a surrounding structure such as a connector between a natural or artificial graft and a patient's body tissue.
  • structures like structure 700 may be used in place of one or more of balloons 422 (FIGS. 15 and 18-23), 512a/512b (FIGS. 25- 30), 422' (FIG. 35), or 422" (FIG. 38), or wherever else a generally similar radially enlargeable structure is needed.
  • Structure 700 includes an outer tube 710 (e.g., of metal hypotube) . Near the distal end of tube 710 pivotable members 720a and 720b are pivotally mounted on a pin 730 which extends transversely across tube 710. The proximal portions of members 710a and 710b are pivotally connected to links 740a and 740b, respectively. The proximal ends of links 740 are pivotally connected to the distal end of wire 750.
  • outer tube 710 e.g., of metal hypotube
  • Axially extending slots 760 are formed in diametrically opposite sides of tube 710 to allow members 720 and 740 to extend radially out of tube 710, for example, as shown in FIG. 40.
  • the distal ends of members 720 can be brought together by pulling wire 750 proximally relative to tube 710.
  • that portion of structure 700 can be radially enlarged (i.e., the distal portions of members 720 can be spread apart) by pushing wire 750 distally relative to tube 710.
  • Structure 700 is therefore another example of a selectively radially enlargeable structure that can be used in accordance with this invention.
  • one or more selectively inflatable balloons 780 may be disposed on structure 700. Each such balloon 780"preferably extends annularly around structure 700. (For greater clarity FIG. 40 only shows the rear half of annular balloon 780.) Balloon 780 and/or similar balloons may be used for such purposes as helping to hold a graft in position around structure 700 during use of structure 700 to transport the graft. Balloon 780 or like balloons may be selectively inflated via an inflation lumen which extends proximally from the balloon along component 710.
  • links 740 can start out more nearly partly overlapping the proximal portions of members 720. Then when wire 750 is pulled proximally relative to tube 710, the distal portions of members 720 will be spread apart.
  • radiologic elements and techniques are used for observation of the apparatus inside the patient may vary.
  • radiologic fluids may be injected into the patient through various lumens in the apparatus to help monitor the location of various apparatus components in the patient, and/or radiologic markers (of which the above-described markers such as 154 and 206 are examples) may be provided anywhere on the apparatus that may be helpful to the physician.

Abstract

L'invention concerne des procédés et un appareil pour acheminer et installer une nouvelle longueur de tubulure entre deux parties d'une tubulure d'un organe existant d'un patient et au moins une partie située à l'extérieur de ladite structure existante. Par exemple, la nouvelle longueur de tubulure peut être utilisée pour un pontage coronarien chez un patient. La nouvelle tubulure peut être un greffon artificiel, un greffon naturel (prélevé sur la patient) ou les deux. On achemine la nouvelle tubulure jusqu'au site à opérer et on l'installe à cet endroit principalement en passant dans la structure de l'organe tubulaire existante du patient, ce qui permet d'éviter toute chirurgie importante sur ce dernier.
EP97945625A 1996-11-07 1997-11-05 Procedes et appareil de greffe medicale Ceased EP0951252A2 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US745618 1996-11-07
US08/745,618 US5976178A (en) 1996-11-07 1996-11-07 Medical grafting methods
US08/844,992 US6120432A (en) 1997-04-23 1997-04-23 Medical grafting methods and apparatus
PCT/US1997/020244 WO1998019634A2 (fr) 1996-11-07 1997-11-05 Procedes et appareil de greffe medicale
US844992 2001-04-27

Publications (1)

Publication Number Publication Date
EP0951252A2 true EP0951252A2 (fr) 1999-10-27

Family

ID=27114493

Family Applications (1)

Application Number Title Priority Date Filing Date
EP97945625A Ceased EP0951252A2 (fr) 1996-11-07 1997-11-05 Procedes et appareil de greffe medicale

Country Status (4)

Country Link
EP (1) EP0951252A2 (fr)
JP (1) JP2001502588A (fr)
AU (1) AU5105798A (fr)
WO (1) WO1998019634A2 (fr)

Families Citing this family (27)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL124037A (en) 1995-10-13 2003-01-12 Transvascular Inc Device and system for interstitial transvascular intervention
EP0932426A4 (fr) 1996-02-02 2003-07-30 Transvascular Inc Methodes et dispositifs permettant de relier des ouvertures menagees dans des vaisseaux sanguins contigus ou d'autres structures anatomiques
US6149681A (en) * 1996-09-20 2000-11-21 Converge Medical, Inc. Radially expanding prostheses and systems for their deployment
US6432127B1 (en) 1996-10-11 2002-08-13 Transvascular, Inc. Devices for forming and/or maintaining connections between adjacent anatomical conduits
US6379319B1 (en) 1996-10-11 2002-04-30 Transvascular, Inc. Systems and methods for directing and snaring guidewires
JP2001503657A (ja) * 1996-11-08 2001-03-21 ハウザー，ラッセル，エイ． 径皮バイパス移植片および固着システム
US6241741B1 (en) 1998-03-09 2001-06-05 Corvascular Surgical Systems, Inc. Anastomosis device and method
US6110188A (en) * 1998-03-09 2000-08-29 Corvascular, Inc. Anastomosis method
US6475222B1 (en) * 1998-11-06 2002-11-05 St. Jude Medical Atg, Inc. Minimally invasive revascularization apparatus and methods
US6248117B1 (en) 1999-04-16 2001-06-19 Vital Access Corp Anastomosis apparatus for use in intraluminally directed vascular anastomosis
US6790229B1 (en) 1999-05-25 2004-09-14 Eric Berreklouw Fixing device, in particular for fixing to vascular wall tissue
AU7473200A (en) * 1999-08-31 2001-03-26 Cleveland Clinic Foundation, The Non-occlusive vascular bypass surgical methods and instruments
US6682540B1 (en) 1999-11-05 2004-01-27 Onux Medical, Inc. Apparatus and method for placing multiple sutures
US7118546B2 (en) 2000-01-11 2006-10-10 Integrated Vascular Interventional Technologies, L.C. Apparatus and methods for facilitating repeated vascular access
US6656151B1 (en) 2000-01-11 2003-12-02 Integrated Vascular Interventional Technologies, L.C. (Ivit, Lc) Vascular access devices and systems
US6595941B1 (en) 2000-01-11 2003-07-22 Integrated Vascular Interventional Technologies, L.C. Methods for external treatment of blood
WO2001051117A1 (fr) 2000-01-11 2001-07-19 Blatter Duane D Ballonnets d'occlusion vasculaire, dispositifs et systemes associes utilises pour acceder aux vaisseaux
US7131959B2 (en) 2003-01-23 2006-11-07 Integrated Vascular Interventional Technologies, L.C., (“IVIT LC”) Apparatus and methods for occluding an access tube anastomosed to sidewall of an anatomical vessel
US6554764B1 (en) 2000-11-13 2003-04-29 Cardica, Inc. Graft vessel preparation device and methods for using the same
AU2003231910A1 (en) * 2002-06-13 2003-12-31 Existent, Inc. Mechanical structures and implants using said structures
WO2003105922A2 (fr) 2002-06-13 2003-12-24 Existent, Inc. Systeme de fil guide
FR2845590B1 (fr) * 2002-10-10 2005-10-21 Jean Francois Garbe Dispositif de liaison entre une prothese et un conduit corporel et dispositif de connexion de deux conduits corporels disposes bout a bout
JP5495587B2 (ja) * 2009-03-09 2014-05-21 オリンパスメディカルシステムズ株式会社 医療機器
EP3179925B1 (fr) * 2014-08-12 2019-06-19 Anastomosis AS Anastomose minimalement traumatique
ES2924871T3 (es) * 2014-11-28 2022-10-11 Bebiler Yazilim Medikal Enduestriyel Tarimsal Arastirmalar Ve Tarim Urunleri Ticaret Ve Sanayo Ltd S Catéter que mantiene el flujo sanguíneo por derivación venosa
US20230233349A1 (en) * 2022-01-21 2023-07-27 Covidien Lp Apparatuses for stent delivery and positioning for transluminal application
US20230233313A1 (en) * 2022-01-21 2023-07-27 Covidien Lp Methods for stent delivery and positioning for transluminal application

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB1288033A (fr) * 1968-10-31 1972-09-06
US4418693A (en) * 1980-12-10 1983-12-06 Leveen Eric G Vein and tubing passer surgical instrument
US4592754A (en) * 1983-09-09 1986-06-03 Gupte Pradeep M Surgical prosthetic vessel graft and catheter combination and method
US5451204A (en) * 1988-07-22 1995-09-19 Yoon; Inbae Multifunctional devices for endoscopic surgical procedures
US5180362A (en) * 1990-04-03 1993-01-19 Worst J G F Gonio seton
US5507769A (en) * 1994-10-18 1996-04-16 Stentco, Inc. Method and apparatus for forming an endoluminal bifurcated graft
US5591226A (en) * 1995-01-23 1997-01-07 Schneider (Usa) Inc. Percutaneous stent-graft and method for delivery thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO9819634A3 *

Also Published As

Publication number Publication date
AU5105798A (en) 1998-05-29
JP2001502588A (ja) 2001-02-27
WO1998019634A2 (fr) 1998-05-14
WO1998019634A3 (fr) 1998-09-11

Similar Documents

Publication Publication Date Title
US6120432A (en) Medical grafting methods and apparatus
WO1998019634A2 (fr) Procedes et appareil de greffe medicale
US20020087046A1 (en) Medical grafting methods and apparatus
US6302905B1 (en) Medical grafting methods and apparatus
US7094248B2 (en) Medical grafting connectors and fasteners
US6475222B1 (en) Minimally invasive revascularization apparatus and methods
EP0951251B1 (fr) Dispositifs de fixation de greffes medicales
US6440163B1 (en) Medical anastomosis apparatus
WO1998055027A2 (fr) Procedes de pontage avec effraction minimale et appareil de replacement partiel d'un canal anatomique tubulaire

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 19990607

AK Designated contracting states

Kind code of ref document: A2

Designated state(s): AT BE CH DE DK ES FI FR GB GR IE IT LI LU MC NL PT SE

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC.

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: ST. JUDE MEDICAL ATG, INC.

17Q First examination report despatched

Effective date: 20031104

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN REFUSED

18R Application refused

Effective date: 20060616