EP0892651A1 - Systeme de traitement ou de diagnostic pour le tissu cardiaque - Google Patents

Systeme de traitement ou de diagnostic pour le tissu cardiaque

Info

Publication number
EP0892651A1
EP0892651A1 EP96913986A EP96913986A EP0892651A1 EP 0892651 A1 EP0892651 A1 EP 0892651A1 EP 96913986 A EP96913986 A EP 96913986A EP 96913986 A EP96913986 A EP 96913986A EP 0892651 A1 EP0892651 A1 EP 0892651A1
Authority
EP
European Patent Office
Prior art keywords
catheter
delivery catheter
distal end
distal
patient
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.)
Withdrawn
Application number
EP96913986A
Other languages
German (de)
English (en)
Inventor
Randy J. Kesten
Carl J. Simpson
Michael Aita
Manuel A. Javier, Jr.
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.)
Eclipse Surgical Technologies Inc
Original Assignee
Cardiogenesis Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Cardiogenesis Corp filed Critical Cardiogenesis Corp
Publication of EP0892651A1 publication Critical patent/EP0892651A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
    • A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
    • A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
    • A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0041—Catheters; Hollow probes characterised by the form of the tubing pre-formed, e.g. specially adapted to fit with the anatomy of body channels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0218—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for minimally invasive surgery
    • 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
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • 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
    • A61B17/3203—Fluid jet cutting instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3478—Endoscopic needles, e.g. for infusion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • 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
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • 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
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
    • 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
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • 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
    • A61B2017/2901—Details of shaft
    • A61B2017/2905—Details of shaft flexible
    • 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
    • A61B2017/2927—Details of heads or jaws the angular position of the head being adjustable with respect to the shaft
    • 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
    • A61B2017/320004—Surgical cutting instruments abrasive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3488—Fixation to inner organ or inner body tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00392—Transmyocardial revascularisation
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system
    • A61M2210/125—Heart

Definitions

  • This invention is directed to elongated devices for therapeutic or diagnostic procedures in a wall of a patient's heart, particularly to the treatment of myocardial tissue experiencing ischemic conditions by revascularization of such myocardial tissue.
  • Myocardial revascularization typically involves formation of one or more channels in a patient's heart wall defining the heart chamber to allow oxygenated blood to flow from the left ventricle of the patient's heart through the endocardium into a patient's ischemic myocardial tissue.
  • the first trials of the revascularization process was made by Mirhoseini et al. See for example the discussions in Lasers in General Suroerv (Williams & Wilkins; 1 989), pp 21 6-223. Another early disclosure of this procedure is found in U.S. Patent 4,658,817 (Hardy). Both of these references describe revascularization procedures which require the chest wall to be opened and which include formation of the revascularization channels through the epicardium, myocardium and endocardium, i.e. the entire heart wall.
  • What has been needed is a system and method for delivering a channel forming device within the patient's heart chamber which provide for the accurate placement of the operative end of the channel forming device against a desired region of the endocardium at the desired orientation and the maintenance of the position of the device within the patient's heart chamber while the revascularization channel is being formed and the heart is beating.
  • the present invention satisfies these and other needs.
  • the present invention is directed to a system and method for delivering an elongated therapeutic or diagnostic device to the interior of a patient's heart chamber which provides access to a wide region of the patient's endocardium and accurately places and effectively holds the operative distal end of the device at a desired location within the patient's heart chamber.
  • a typical device may be used to form a channel into the wall defining the heart chamber or perform other ablation treatments and diagnosis.
  • the system also allows the position of the operative distal end of the device to be readily changed to facilitate performing therapeutic or diagnostic procedures at a plurality of locations within the heart chamber and at a desired orientation with respect to the patient's endocardium.
  • One presently preferred embodiment of the invention includes a first delivery catheter which has proximal and distal ends, a port in the distal end and an inner lumen extending within the catheter to the port in the distal end.
  • the first delivery catheter is provided with a preshaped distal section, or a distal section which can be deformed or shaped once positioned within the patient's heart chamber.
  • the embodiment also includes a second delivery catheter or sleeve longer than the first delivery catheter which is slidably and preferably rotatably disposed within inner lumen of the first catheter.
  • the second delivery catheter likewise has proximal and distal ends, a port in the distal end an inner lumen extending within the second catheter to the port in the distal end.
  • the distal section of the second delivery catheter may be straight, i.e. in line with the main catheter section but it is preferably provided with a preshaped distal section, or a distal section which can be deformed or shaped once positioned within the patient's heart chamber, so as to facilitate directing an elongated therapeutic or diagnostic device slidably disposed within the inner lumen of the second delivery catheter toward the region of the endocardium where the procedure is to be performed.
  • the orientation is preferably perpendicular or near perpendicular with the endocardial surface of the patient's heart wall.
  • a presently preferred elongated therapeutic or diagnostic device is a laser based optical fiber system for forming channels within the wall of the patient's heart.
  • the optical fiber system which is adapted to emit laser energy from its distal end, is slidably disposed within the inner lumen of the second delivery catheter and is long enough to extend out the distal end of the second delivery catheter to be able to engage tissue of the endocardium while forming the channel or performing other types of procedures.
  • the system is introduced into a peripheral artery, such as the femoral artery, and to be advanced through the patient's arterial system until the distal end of the first catheter is disposed within the patient's left ventricle or slightly down stream from the patient's aortic valve in the ascending aorta.
  • the first delivery catheter may be advanced through a previously introduced guiding catheter which has a distal end within the left ventricle or within the ascending aorta or over a previously positioned guidewire or catheter.
  • the second delivery catheter is rotatably and slidably disposed within the inner lumen of the first delivery catheter to facilitate the desired placement and orientation of the shaped or shapable distal extremity thereof within the left ventricle.
  • Perpendicularity or near perpendicularity of the elongated therapeutic or diagnostic device with respect to the inner endocardial surface of the heart chamber is usually required in order to effectively couple the ablation energy to the tissue.
  • such perpendicularity helps to maintain the position of the distal end of the device, particularly a channel forming device, against the tissue to be ablated or removed to form the channel. Otherwise, the operative tip of the therapeutic or diagnostic device tends to move laterally while the heart is beating resulting in mislocation of the channel, or ablated tissue or medical procedure.
  • Longitudinal and rotational movements of the first and second delivery catheters provides access to a wide region of the patient's endocardial surface and allows for the accurate placement of the operative end of the therapeutic or diagnostic device within the patient's left ventricle in a number of positions.
  • Extension of the second delivery catheter out the distal end of the first delivery catheter to engage the endocardium of the patient's heart can also ensure effective contact by providing more support to the therapeutic or diagnostic device.
  • the location of the distal end of the therapeutic or diagnostic device within the heart chamber and particularly with respect to the endocardial surface can be detected fluoroscopically by providing a radiopaque marker on the distal end of the device.
  • the use of dye injections out the port in the distal end of second delivery catheter or a radiopaque marker on the distal end of the second delivery catheter, or both may be employed to locate the distal end of the first and second delivery catheters.
  • Other means such as a variety of proximity detectors may be employed to detect contact between the distal end of the therapeutic or diagnostic device or the delivery catheters and the endocardium.
  • the distal sections of the first and second delivery catheters may be preformed into a desired shape so that they will provide a desired orientation for the delivery system when it extends into the patient's heart chamber.
  • the catheters may also be provided with control lines or other suitable means (e.g. a shape memory or a superelastic NiTi element) to deflect or otherwise shape the distal sections of the catheters once the distal extremity of the delivery system extends into the heart chamber.
  • suitable means e.g. a shape memory or a superelastic NiTi element
  • the guiding catheter (if used) and first delivery catheter are both preferably relatively stiff catheters so that the position of the therapeutic or diagnostic device will be maintained during the procedure even though the heart is beating.
  • the functions of the first and second delivery catheters can be combined into a single catheter, if the shape of the distal extremity of such a single catheter is controllable after the distal extremity is disposed within the patient's heart chamber.
  • the delivery system has an elongated main section and a distal extremity which extends within the patient's heart chamber which has a double bend.
  • the distal extremity has a proximal portion extending away from the main section at an angle and a distal portion extending away from the proximal portion of the distal extremity at an angle.
  • the proximal portion of the distal extremity extends away from the main catheter section at an angle of about 40° to about 1 20°, preferably about 60° to about 120°.
  • the distal portion of the distal extremity extends away from the proximal portion at an angle of about 40° to about 120°, preferably about 60° to about 120°.
  • the length of the proximal portion of the distal extremity may range from about 0.5 to about 3 cm, preferably about 1 to about 2 cm and the length of the distal portion may range from about 0.5 to about 2.5 cm, preferably about 0.5 to about 1 .5 cm.
  • the delivery system is in the form of a single catheter and a second version of this embodiment the delivery system has first and second delivery catheters as in the previously discussed embodiments.
  • the orientation of the distal portion in the first version may be in one direction for clockwise rotation of the main portion of the delivery system or in another opposite direction for counter clockwise rotation of the main portion.
  • the proximal portion of the delivery system is the distal extremity of the first delivery catheter and the distal portion of the delivery system is the distal section of the second delivery catheter which is slidably disposed within the inner lumen of the first delivery catheter.
  • a positioning sheath may be disposed within the inner most inner lumen of the delivery system which is extended to the surface of the heart wall, to further support the therapeutic or diagnostic device. However, if the delivery system has two changes in direction the advancement of a positioning sheath may become difficult.
  • the anatomy of the left ventricle can vary considerably as to dimensions and to shape from patient to patient.
  • the channel forming member with the first embodiment may not be able to be directed to the entire region in which channels are to be formed.
  • the shape of the guiding catheter or the first delivery catheter and the orientation thereof within the left ventricle can further complicate placement of the channel forming means or other therapeutic or diagnostic device.
  • the rotation of the first and second delivery catheters will ensure that the therapeutic or diagnostic can reach all or at the very least a major part of the region in which the device is to be operated.
  • the passageway formed into the myocardium may be used for other purposes.
  • therapeutic or diagnostic agents may be introduced into the channel for delivery to the patient's endocardium or myocardium.
  • the therapeutic or diagnostic agent may be incorporated into a biocompatible matrix deposited within the channel for delivery or release over an extended period.
  • the channel forming device may be removed and a catheter with an inner lumen extending the length thereof may be advanced through the inner lumen of the second delivery catheter until the distal end of the catheter extends into the channel formed in the wall of the patient's heart.
  • a therapeutic or diagnostic agent may then be delivered through the inner lumen of the catheter and out a port in the distal end into the channel such as described in copending application Serial No. 08.
  • the drug delivery catheter may be generally a simple elongated flexible tube with an inner lumen extending therein to a port or opening in the distal end of the catheter.
  • the outer dimensions are suitable to provide longitudinal movement of the drug delivery catheter within the second delivery catheter.
  • the distal extremity of the drug delivery catheter is preferably configured to readily fit into the channel formed in the endocardium and myocardium so that delivery of the therapeutic or diagnostic agent well into the channel is ensured.
  • the laser device may be replace with a RF energy or an ultrasonic energy delivery system which damages myocardial tissue without forming a channel.
  • injection of small quantities of chemical ablation media such as ethyl alcohol or phenol may likewise be used for similar results.
  • Fig. 1 is an elevational view of an embodiment of the delivery system of the invention disposed within the arterial system of a patient with the distal end of the system disposed within the patient's left ventricle.
  • Fig. 2 is a transverse cross-sectional view of the delivery system shown in Fig. 1 taken along the lines 2-2.
  • Fig. 3 is an elevational view of the system shown in Fig. 1 with the second delivery catheter extending out of the distal end of the first delivery catheter and the distal end thereof pressed against the endocardial layer.
  • Fig. 4 is an elevational view of the system shown in Fig. 1 with a channel forming device, in this case an optical fiber, extending out of the second delivery catheter and into a channel formed by laser energy emitted out the distal end of the optical fiber.
  • a channel forming device in this case an optical fiber
  • Fig. 5 is a schematic representation of the degrees of orientation of the first delivery catheter within the left ventricle of a patient's heart.
  • Fig. 6 is longitudinal cross-sectional view of the distal end of the optical laser shown in Fig. 4.
  • Fig. 7 is a perspective view of an alternative embodiment of the invention.
  • Fig. 8 is a perspective view of an embodiment which is the mirror image of the embodiment shown in Fig. 7.
  • Fig. 9 is an enlarged view of the embodiment shown in Fig. 8 with indications of orientations of the distal portions of the embodiment.
  • Fig. 10 is a elevational view of the distal portion of a channel forming device having an auger on the distal tip.
  • Fig. 1 1 is an elevational view of the distal portion of a channel forming device having an abrading member on the distal tip.
  • Fig. 1 2 is an elevational view of the distal portion of a channel forming device having a circular cutting blade on the distal tip.
  • Fig. 1 3 is an elevational view of the distal portion of a channel forming device having a resistance heated distal tip.
  • Fig. 14 is an elevational view of the distal portion of a channel forming device having a jet forming aperture in the distal tip.
  • Fig. 1 5 is a perspective view of an alternative embodiment of the invention.
  • Fig. 1 6 is an elevational view of an alternative distal section of the outer catheter shown in Fig. 1 5.
  • Fig. 17 is a transverse cross-sectional view of the outer catheter shown in Fig. 1 6 taken along the lines 1 7-17.
  • Fig. 18 is an elevational view of yet another alternative embodiment of the invention.
  • Fig. 19 is a transverse cross-sectional view of the embodiment shown in Fig. 18 taken along the lines 19-19.
  • Fig. 20 illustrates the positioning of the assembly of an embodiment of the invention within the patient's left ventricle with the discharge axis of the first catheter coinciding with the axis of the patient's left ventricle.
  • Fig. 21 illustrates the distal extremity of the delivery catheter system positioned against a patient's intraventricular septal wall.
  • Fig. 22 illustrates the position of the assembly similar to that shown in Fig. 21 except that the distal extremity of the delivery catheter system is disposed more centrally within the left ventrical. The accessible region of the patient's endocardium with the delivery system in this position, is shaded.
  • Fig. 23 depicts the assembly shown in Fig. 15 with the distal extremity of the outer delivery catheter at a large obtuse angle with respect to the main portion of the catheter.
  • Fig. 24 illustrates the assembly shown in Fig. 23 positioned within a patient's left ventricle to access the apical region of the patient's left ventricle which includes the lower interventricular septum region.
  • Fig. 25 illustrates the assembly shown in Fig. 23 with the inner catheter rotated about 180° from that shown in Fig. 23.
  • Fig. 26 illustrates the access gained to the upper portions of the patient's left ventricle by rotating the inner catheter which includes the upper portions of the patient's interventricular septum.
  • Figs. 1 -3 schematically illustrates one presently preferred delivery system 10 of the invention with a distal portion thereof disposed within the left ventricle 1 1 of a patient's heart 12.
  • the delivery system
  • a guiding catheter 13 includes a guiding catheter 13, a first delivery catheter 14 slidably and rotatably disposed within the inner lumen 1 5 of the guiding catheter and a second delivery catheter 1 6 which is slidably disposed within the inner lumen 17 of the first delivery catheter.
  • An optical fiber 18 with a laser focusing lens 20 is slidably disposed within the inner lumen 21 of the second delivery catheter 1 6.
  • the guiding catheter 13 may be of conventional construction which includes a inner lubricous lining 22, a braided fiber reinforcement 23 and an outer jacket 24 which may be formed of suitable polymeric material in a conventional manner, e.g. extruding onto the braided fiber reinforcement.
  • suitable polymers include polyethylene, polyurethane and the like.
  • the strands of the fiber reinforcement 23 may be stainless steel, or other suitable high strength materials including suitable polymeric materials.
  • the lubricous inner liner 22 may be formed of a suitable fluoropolymer such as poly(tetrafluoro)ethylene which is sold under the trademark Teflon ® .
  • the overall length of the guiding catheter 13 is about 70 to about 1 10 cm, the outer diameter is about 0.1 to about 0.1 5 inch (2.5-3.75 mm) and an inner diameter of about 0.07 to about 0.1 inch (1 .8-2.5 mm) .
  • the first delivery catheter 14 is formed in a similar manner as the guiding catheter 1 3 except that the outer diameter of the first delivery catheter is configured so that it can be readily moved longitudinally and readily rotated within the guiding catheter by manipulating the proximal end which extends out of the patient.
  • the overall length of the first delivery catheter 14 is about 10 to about 40 cm longer than the guiding catheter 13 to ensure that the distal end and the proximal end of the first delivery catheter extend out the distal end and the proximal end respectively of the guiding catheter so that movement of the distal end of the first delivery catheter can be effected by manipulation of the proximal end.
  • a pair of radiopaque markers 25 and 26 are provided on the distal end 27 of the first delivery catheter 14 to allow the fluoroscopic observation thereof by the attending physician to determine the location and the orientation of the distal end within the patient's left ventricle 1 1 .
  • the second delivery catheter 16 is an elongated polymeric tubular member which is formed of suitable thermoplastic polymers such as polyethylene, polyamide, polyether amide and polyurethane copolymer such as Pebax.
  • the overall length of the second delivery catheter 1 6 is greater than the overall length of the first delivery catheter 14 to allow movement of the distal end 28 of the second delivery catheter 1 6 by manipulation of its proximal end which extends out the proximal end of the guiding catheter which in turn extends out of the patient.
  • the length of the second delivery catheter 1 6 is typically about 10 to about 30 cm longer than the first delivery catheter 14.
  • the outer diameter of the second delivery catheter 1 6 is about 0.002 to about 0.008 inch (0.05-
  • a radiopaque band 30 may be provided on the distal end 28 of the second delivery catheter 1 6 to allow fluoroscopic detection of the distal end during the procedure.
  • the elongated optical fiber 1 8 is advanced out the port 32 in the distal end 28 of the second delivery catheter 1 6 to contact the surface of the endocardium 31 .
  • Laser energy is then directed through the optical fiber 18 out the lens 20 on the distal end of the optical fiber onto the endocardial tissue as shown in Fig. 4.
  • the axial force applied to the proximal end of the optical fiber 1 8 is preferably sufficient to ensure contact with endocardial and myocardial tissue as the channel 33 is being formed therethrough, but the force should not exceed the level which will cause the optical fiber to mechanically penetrate heart tissue. As shown in more detail in Fig.
  • the lens 20 on the optical fiber 18 has a cylindrical outer surface terminating in a convex distal tip 34.
  • the distal end of the optical fiber 1 8 extends into the interior of the lens 20 and preferably terminates at a location proximal to the internal aspheric or ogival shaped surface 35 so as to be in a light transmitting relationship therewith.
  • the distal end of the optical fiber 1 8 should be secured to the interior of lens 20 by suitable adhesive such as epoxy to prevent dislodgement of the lens when the device is disposed within the patient's body.
  • suitable adhesive such as epoxy
  • the overall length of the optical fiber 18 is longer than the second delivery catheter 1 6 and it is preferably configured to extend out of the second delivery catheter up to about 1 5mm, preferably about 1 to about 10 mm to form the channel 33.
  • the outer diameter of the lens 20 generally will be essentially about the same size as the desired diameter of the channel, e.g. about 0.5 to about 2 mm, preferably about 1 to about 1 .5 mm.
  • the optical fiber 18 should have a diameter of about 0.2 to about 0.4 mm to provide the flexibility required to pass through the passageway of the second delivery catheter 1 6, but it may require support such as described in copending application Serial No.
  • the optical fiber 18 may be a single fiber as describe above or a plurality of optical fibers.
  • the laser energy emitted from the lens 20 on the distal end of the optical fiber 18 may be emitted in a pulsatile manner ranging from about one to about 5 pulses or more during each heart beat.
  • the energy level per pulse typically ranges about 0.5 to about 3 joules, preferably about 0.8 to about 2 joules.
  • a higher laser energy level may be desirable when forming the channel in the endocardium than when forming the channel in myocardial tissue.
  • the universal movement of the distal ends of the first delivery catheter 14, the second delivery catheter 1 6 and the optical fiber 1 8 within the patient's left ventricle is illustrated in Figs. 1 and 5.
  • the guiding catheter 13 is preferably maintained stationary with its distal end either closely adjacent to the side of the aortic valve 36 within the ascending aorta (not shown) or within the interior of the left ventricle 1 1 as shown in phantom in Fig. 1 . If desired, the distal end of the guiding catheter 13 may be first inserted into the left ventricle where the first delivery catheter 14 is extended out the distal end of the guiding catheter and then withdrawn through the aortic valve 36 into the ascending aorta. The first delivery catheter 14 may be moved vertically within the heart chamber 1 1 by extending or withdrawing the catheter along the Z axis and be rotated about the Z axis as shown by angle ⁇ on the circular projection 37.
  • the deflection of the distal extremity of the first delivery catheter 13 from the Z axis, angle ⁇ may be formed or adjusted manually before inserting the first delivery catheter into the patient or it may be adjusted after positioning within the heart chamber, e.g. by providing one or more control lines (not shown) extending through the catheter and secured to the distal end 28 thereof in a manner which is widely practiced with electrophysiological type catheters..
  • the second delivery catheter may then be extended a distance r to contact the surface of the endocardium 31.
  • the guiding catheter 13 and the first delivery catheter 14 are both constructed to be relatively stiff to prevent significant movement thereof when the optical fiber 18 is advanced within the heart chamber 1 1 during channel formation. If needed, mechanical elements (not shown) extending from the guiding catheter 13 or the first delivery catheter 14 may be utilized to engage the endocardium surface on a side opposite the channel forming site to bolster the position of these catheters during the procedure.
  • the guiding catheter 13 may be shaped to ensure that the distal portion of the catheter is more or less centrally located within the ventricle 1 1 to allow complete rotation of the first delivery catheter within the heart chamber.
  • the guide catheter 13 is first introduced into the patient's arterial system, preferably by means of the Seldinger technique, (e.g. the femoral artery) and advanced through the arterial system including the aorta until the distal end of the guide catheter is disposed at a desired location either within the left ventricle 1 1 or in the ascending aorta downstream from the aortic valve.
  • the first delivery catheter 14, the second delivery catheter 16 and the optical fiber 18, or other channel forming device may then be advanced together or sequentially through the guiding catheter into the left ventricle.
  • the first delivery catheter 14 is advanced out of or withdrawn into the guiding catheter 13 (as shown in Fig.
  • the distal extremity of the first delivery catheter 14 is preshaped, the distal extremity forms the desired shape when exiting the guiding catheter 13. If means are provided to deflect the distal tip of the first delivery catheter 14, the deflection means may be employed to shape the distal extremity after it exits the guiding catheter to direct the distal end of the first delivery catheter toward the desired location on the endocardium.
  • the second delivery catheter 1 6 may be extended out the distal end 27 of the first delivery catheter 14 to engage the portion of the endocardium into which the channel 33 is to be formed.
  • the location of the distal end of the second delivery catheter can be detected fluoroscopically by means of the radiopaque marker 30.
  • the elongated channel forming device such as optical fiber 18 may then be advanced through the inner lumen 21 of the second delivery catheter 1 6 and out the port 32 in the distal end 28 thereof into the endocardium tissue to form the channel 33 therein.
  • pressure is applied to the channel forming means so as to maintain contact with the endocardial and myocardial tissue when forming the channel 33 of a desired length.
  • the channel forming device may be withdrawn and repositioned within the left ventricle 1 1 to form a channel at another location within the patient's heart wall.
  • Figs. 7-9 illustrate another presently preferred embodiment which includes a first delivery catheter 40 which has a main section 41 and distal extremity 42.
  • the distal extremity 42 has a proximal portion
  • the distal portion 44 is essentially
  • Optical fiber 1 80° from the distal portion 44 shown in Fig. 8.
  • Optical fiber 1 8 which is slidably disposed within the inner lumen 46, extends out the port 47 in the distal end of the catheter 40.
  • the portion of the optical fiber 45 which extends out of the distal end of the first delivery catheter 40 may be provided with reinforcement (not shown) on the exterior thereof.
  • a rotating auger type channel forming device 50 is shown in Fig. 10 which has a cutting head 51 with a spiral cutting edge 52 secured to the drive shaft 53 rotatably supported within the elongated housing 54.
  • abrasive type channel forming device 60 as shown in Fig. 1 1 which has an enlarged bulbous tip 61 which has abrasive material thereon and which is secured to the drive shaft 62 rotatably supported within the elongated housing 63.
  • Fig. 10 which has a cutting head 51 with a spiral cutting edge 52 secured to the drive shaft 53 rotatably supported within the elongated housing 54.
  • abrasive type channel forming device 60 as shown in Fig. 1 1 which has an enlarged bulbous tip 61 which has abrasive material thereon and which is secured to the drive shaft 62 rotatably supported within the elongated housing 63.
  • Fig. 10 which has a cutting head 51 with a spiral cutting edge 52 secured to the drive shaft 53 rotatably
  • Fig. 12 depicts a channel forming device 80 which has a distal tip 81 which is resistively or inductively heated by conductors 82 and 83.
  • the operating temperature of the distal tip 81 is maintained about 80° to about 1 10° C. which is sufficient to form the channel through the endocardium into the myocardium.
  • a thermocouple or other temperature sensing device 84 may be imbedded into the distal tip 81 to determine the temperature thereof.
  • the signal developed by the sensing device 84 may be used to control the electrical power to the distal tip 81 in a conventional manner.
  • FIG. 14 illustrates yet another type of channel forming device 90 wherein a high velocity fluid jet 91 emitted from a discharge nozzle 92 in the distal end of inner tubular member 93 is employed to form the channel.
  • debris from the channel forming operation is aspirated away from the site through the annular lumen 94 between the inner tubular member 93 and the outer tubular member 95 to avoid passage of such debris into the aorta and ultimately into the arterial system of the patient's brain which can result in a stroke or into the coronary artery system which can result in a myocardial infarct.
  • This embodiment includes an outer catheter 100 having a shaped distal section 101 , a port 102 in the distal end of the catheter and an inner lumen 103 extending within the outer catheter to the port in the distal end.
  • This embodiment also includes an inner catheter 104 slidably and rotatably disposed within the inner lumen 103 of the outer catheter 100 which has a shaped distal section 105, a port 106 in the distal end of the inner catheter and an inner lumen 107 extending therein to the port in the distal end.
  • An optical fiber assembly 108 is slidably disposed within the inner lumen 107 of inner catheter 104. Additional details of the optical fiber assembly 108 can be found in copending application Serial No. 08/584,957, filed January 1 1 , 1 996, entitled CHANNEL FORMING DEVICE WITH PENETRATING LIMITER, assigned to the present assignee which is incorporated herein by reference in its entirety.
  • the distal section 101 of the outer catheter 100 is at an angle with respect to the main shaft section 109 of the outer catheter of about 90° to about 180°, preferably about 135° to about 1 65° .
  • the distal section 105 of the inner catheter 103 is at an angle with respect to the main shaft section 1 10 of the inner catheter of about 45° to about 180° , preferably about 60° to about 130° .
  • the distal section 101 of the outer catheter 100 desirably orients the inner catheter 103 extending out the distal end of the outer catheter in the same direction as the axis of the heart chamber so that rotation of the inner catheter within the outer catheter points the distal section 105 of the inner catheter 104 in a generally perpendicular direction to the endocardium 1 1 1 defining the chamber. Longitudinal and rotational movement of the inner catheter 103 provides access to a large region of the endocardium 1 1 1 .
  • Figs. 17 and 18 illustrate a presently preferred embodiment wherein the outer catheter 100 is provided with a supereleastic metallic shaping member 1 12 to shape and support the distal section 101 of the outer catheter as shown.
  • the pseudoelastic properties of the support member 1 12 allow the distal section 101 to be readily straightened to facilitate entry and advancement through the patient's vasculature, but when the distal section 101 is no longer restrained in the heart chamber, the stress induced martensite phase of the NiTi alloy transforms back to the austenite phase and the remembered shape.
  • the shaped shaping member 1 1 2 causes the distal section 101 to take the shape remembered by the shaping member 1 12.
  • the pseudoelastic properties at body temperature require that the metallic member be predominantly in the austenite phase at or below body temperature.
  • the shaping member 1 12 may be in a martensite phase at body temperature with the curved memory of the austenite phase being activated by heating the shaping member by means of an electrical current or other means to raise the temperature of the metallic member to a temperature which is high enough to convert a predominant amount of the martensite phase to the austenite phase thereby causing the member to transform into the remembered curved shape.
  • the preferred alloy is an equiatomic alloy of nickel and titanium. See for example the alloy compositions and thermomechanical processing described in U.S. Patent No. 5,341 ,818 (Abrams et al. ) which is incorporated herein in its entirety by reference.
  • the nickel-titanium alloys and thermomechanical processing described in this patent would be suitable to manufacture the shaping member 1 10 so as to provide pseudoelastic properties at body temperature.
  • Figs. 1 8-1 9 depict a distal section 101 ' suitable for the outer catheter 100 which is formed of a pseudoelastic alloy such as described above.
  • the distal section 101 ' has a plurality of transverse slots 1 13 in the outer curved portion thereof to facilitate bending without kinking. Longitudinal slots 1 14 may also be provided along the side portion of the distal extremity 101 ' to further facilitate bending without kinking.
  • the distal section 101 ' may be formed of a shape memory alloy and be heated to the transformation temperature to generate the remembered shape.
  • the alloy composition and thermomechanical processing is chosen to ensure that the transformation temperature is less than 100°C, preferably less than 85°C.
  • Fig. 20 illustrates placement of the outer catheter 100 within the patient's left ventricle so that the main shaft section 1 10 of the inner delivery catheter lies along the ventricular axis 1 15.
  • the inner catheter 103 can be moved longitudinally and rotationally to facilitate perpendicular or near perpendicular orientation of the optical fiber with the endocardial surface when the optical fiber engages the endocardium 1 1 1 .
  • FIG. 21 depicts the distal extremity of the outer delivery catheter 100 in position against the interventricular septum 1 1 61.
  • Another advantage of an outer catheter 100 with a large angle bend between the main catheter section 109 and the distal section 101 is shown in Figs. 23 and 24, is the ability to access the apical area 1 1 8 within the left ventricle which has been shaded, including the lower regions of the interventricular septum.
  • the angle between the distal section 105 and the main section 1 10 of the inner delivery catheter 104 shown by double point arrow 1 19 can range from about 30° to about 180°. Withdrawal of the outer delivery catheter 100 and rotation of the inner delivery catheter 104 allows access to the upper portions of the heart chamber as shown in Figs. 25 and 26 including the upper portions of the interventricular septum 1 16.
  • the curvature between the bent and essentially straight portions of the delivery catheters generally must be great enough to allow for the passage of the therapeutic or diagnostic device through the inner lumen thereof. A radius of curvature from about 2 to about 30 mm has been found suitable in most instances.

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Abstract

La présente invention concerne un système servant à amener sur place l'extrémité active distale d'un appareil thérapeutique ou de diagnostic, système qui comprend une première sonde d'acheminement, de préférence logée, de façon à pouvoir coulisser et tourner, dans la lumière intérieure d'une sonde de guidage. Une deuxième sonde d'acheminement peut être logée, de façon à coulisser, dans une lumière intérieure de la première sonde d'acheminement et comporter une lumière intérieure réalisée de manière à recevoir, de façon qu'il puisse coulisser, un appareil allongé servant à la thérapeutique ou au diagnostic, tel qu'un dispositif formant un canal, par exemple une fibre optique reliée à une source de lumière laser. L'extrémité distale de la première sonde d'acheminement a, ou peut avoir, une forme telle, à l'intérieur de la cavité cardiaque du patient, qu'un mouvement longitudinal de la première sonde d'acheminement l'amenant dans la lumière intérieure de la sonde de guidage ou l'en retirant, et une rotation de la première sonde d'acheminement, facilitent le positionnement précis de l'extrémité distale de l'appareil thérapeutique ou de diagnostic à un ou plusieurs emplacements désirables à l'intérieur de la cavité cardiaque du patient. La deuxième sonde d'acheminement est sortie de la lumière intérieure de la première sonde d'acheminement jusqu'à ce que l'extrémité distale dépasse de celle de la première sonde d'acheminement et fournisse un passage au dispositif thérapeutique ou de diagnostic, pour qu'il entre en contact avec la surface endocardiaque en lui étant perpendiculaire ou sensiblement perpendiculaire. Dans l'un des modes de réalisation, la partie distale de la première sonde d'acheminement présente une double courbure pour faciliter l'approche de la surface de l'endocarde à angle droit dans certaines situations.
EP96913986A 1995-05-10 1996-05-09 Systeme de traitement ou de diagnostic pour le tissu cardiaque Withdrawn EP0892651A1 (fr)

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US43874395A 1995-05-10 1995-05-10
US438743 1995-05-10
US64685696A 1996-05-08 1996-05-08
PCT/US1996/006700 WO1996035469A1 (fr) 1995-05-10 1996-05-09 Systeme de traitement ou de diagnostic pour le tissu cardiaque
US646856 2003-08-22

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