WO1990007909A1 - Dilatation catheter assembly with cutting element - Google Patents

Dilatation catheter assembly with cutting element Download PDF

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Publication number
WO1990007909A1
WO1990007909A1 PCT/US1990/000337 US9000337W WO9007909A1 WO 1990007909 A1 WO1990007909 A1 WO 1990007909A1 US 9000337 W US9000337 W US 9000337W WO 9007909 A1 WO9007909 A1 WO 9007909A1
Authority
WO
WIPO (PCT)
Prior art keywords
cutting element
tissue
assembly
dilatable
bladder
Prior art date
Application number
PCT/US1990/000337
Other languages
French (fr)
Inventor
Ralph V. Clayman
Original Assignee
Applied Urology, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Applied Urology, Inc. filed Critical Applied Urology, Inc.
Publication of WO1990007909A1 publication Critical patent/WO1990007909A1/en

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Classifications

    • 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
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • 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
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • 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
    • A61B18/08—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by means of electrically-heated probes
    • A61B18/082—Probes or electrodes therefor
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22061—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
    • 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
    • A61B2017/22051—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22062—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 with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation to be filled with liquid
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00107—Coatings on the energy applicator
    • A61B2018/00148—Coatings on the energy applicator with metal
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00214—Expandable means emitting energy, e.g. by elements carried thereon
    • A61B2018/0022—Balloons
    • 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
    • A61B2018/00053—Mechanical features of the instrument of device
    • A61B2018/00273—Anchoring means for temporary attachment of a device to tissue
    • A61B2018/00279—Anchoring means for temporary attachment of a device to tissue deployable
    • A61B2018/00285—Balloons
    • 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
    • A61B2018/00386—Coronary vessels
    • 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
    • A61B2018/00404—Blood vessels other than those in or around the heart
    • A61B2018/00422—Angioplasty
    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/1213—Generators therefor creating an arc
    • 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
    • A61B18/1206—Generators therefor
    • A61B2018/1246—Generators therefor characterised by the output polarity
    • A61B2018/1253—Generators therefor characterised by the output polarity monopolar
    • 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
    • A61M3/00—Medical syringes, e.g. enemata; Irrigators
    • A61M3/02—Enemata; Irrigators
    • A61M3/0279—Cannula; Nozzles; Tips; their connection means

Definitions

  • the present invention is in the field of surgi ⁇ cal devices, particularly dilatation catheters. Specif ⁇ ically- it concerns a dilatation catheter whose expandable member carries a cutting element which concurrently in ⁇ cises the tissue being subjected to dilatation forces, thereby reducing trauma and damage to such tissue from the dilatation forces.
  • Dilatation catheters are used to dilate body vessels, orifices and conduits such as an artery narrowed by atherosclerotic plaque and/or fiberomuscular disease or to dilate a constricted or obstructed ureter or urethra. They basically consist of an elongated catheter having an inflatable balloon or bladder at or near its distal end. A guide wire or other axial support means is often included to improve the torque control or "steerability" of the apparatus.
  • the major advantage of dilatation catheter use over conventional surgery is that it is less invasive. Nonetheless, the tissue that is stressed is often also subjected to significant trauma. As the bladder expands, it exerts pressure on the surrounding tissue, causing the tissue to compress, deform and expand.
  • a principal object of the present invention is to provide a dilatation catheter that permits tissue to be stressed, even beyond its limit of deformability, without experiencing uncontrolled tearing and the undesirable conditions associated therewith.
  • the invention is a dilatation catheter assembly comprising in combination: an elongated tubular body hav ⁇ ing a distal end carrying a radially dilatable member adapted to dilate and exert pressure on surrounding body tissue; means for dilating the dilatable member and a cut- ting element carried on the exterior of the dilatable member that moves radially in concert with the exterior of the dilatable member that is adapted to incise said tis ⁇ sue, thereby reducing damage to said tissue from dilata ⁇ tion forces.
  • the novel catheter of the invention con ⁇ currently exerts pressure on the tissue and makes a clean, sharp incision in the tissue while the tissue is subjected to the dilatation forces exerted by the dilating member.
  • the incision allows the tissue to separate along a pre- determined path and in a relatively clean, trauma-free manner as compared to the uncontrolled tearing that occurs when using prior devices.
  • another aspect of the invention is a method for dilating a body conduit, vessel or orifice comprising: inserting thereinto a dilatation catheter assembly comprising an elongated tubular body having a distal end carrying a radially dilatable member adapted to dilate and exert pressure on surrounding body tissue and a cutting element carried on the exterior of the dilatable member; dilating the dilatable member to an extent that causes the tissue to be simultaneously stressed by the dilatable member and incised by the cutting member; radi ⁇ ally contracting the dilatable member to cause the dilat ⁇ able member and cutting element to disengage the tissue; and withdrawing the dilatation catheter assembly there- from.
  • Figure 1 is a partly cross-sectional, isometric view of one embodiment of the invention catheter.
  • Figure 2 is a cross-sectional view taken along line 2-2 of Figure 1.
  • Figure 3 is a perspective, schematic sectional view of a portion of another embodiment of the invention catheter positioned within a body conduit.
  • Figure 4 is a sectional, side view of the embod ⁇ iment of Figure 3 in its deflated state.
  • Figure 5 is a sectional side view of the embodi ⁇ ment of Figure 3 in its inflated state.
  • Figure 6 is a cross-sectional view along line 6-
  • Figure 7 is a sectional elevational view of another embodiment of the invention.
  • Figure 1 depicts a dilatation catheter assembly, generally designated 10, that may be used for dilating a body vessel or conduit, such as a ureter or urethra, to treat a blockage or other obstruction.
  • the main elements of catheter assembly 10 are: an adapter 11 that defines the proximal end 12 of the assembly and a site for various ports to the assembly; a catheter body 13 having a triple lumen 14 ( Figure 2); an inflatable balloon or bladder member 15; a stiffening stylet 16 that extends longitudinally within one of the three lumens of the catheter body; and a cutting element 17.
  • one of the three lumens 14 serves as an inflation/deflation passageway 18, a second carries stylet 16 and serves as a drainage/infusion passageway, and a third carries cutting element 17.
  • the adapter 12 serves as a site for a bladder inflation/deflation port 19 that is attached to a source of inflation medium (not shown) for inflating the bladder or a suction source (not shown) for deflating the bladder.
  • Port 19 has a valve 20 for regulating the inflation medium or suction, as the case may be.
  • Port 19 connects into the proximal end of an inflation/deflation passageway 18 that extends from the port 19 to the bladder.
  • the adapter also serves as a site for the drainage tube inlet/outlet port 22 and a cutting element port 23. The drainage port is connected to the proximal end of the lumen that carries the stylet 16.
  • the drainage port may serve as a site for removing fluid from the lumen or as a site for infusing fluid into the lumen.
  • the distal end of the catheter body has a series of drain holes 24 to facilitate flushing the lumen with fluid or voiding the bladder.
  • a "banana plug" cutting element connector 25 is affixed to the end of the cutting element port and the cutting element extends from the connector through the lumen of the catheter body and exits therefrom via an aperture 26 and continues along the exterior of the bladder.
  • the cutting element consists of a thin wire which has an external incising edge that faces outwardly from the bladder. Alternatively, the cutting element may be a sharp edge, beam, or cauterizing element.
  • the element/bladder is/are constructed (e.g., the element is flexible or expandable) such that the element is car ⁇ ried on the exterior of the bladder (at least when the bladder is inflated) but is not capable of incising the bladder.
  • the portion of the exterior of the bladder that is exposed to the element may carry a protec- tive cover (not shown) to further guard against the blad ⁇ der being incised by the element.
  • the element may be car ⁇ ried at a predetermined spacing from the bladder surface or directly on the surface. When carried on the surface the element may be an integral part of the surface or at ⁇ tached to the surface. If desired the cutting element may be extended/retracted manually via the connector into/out of the catheter body.
  • the distal end of the assembly includes a coudet tip 27.
  • a coudet tip 27 Such structure may not be necessary or desirable for dilating other conduits/ orifices.
  • the assembly may option ⁇ ally include another lumen and "Foley" type balloon (not shown) distally of the dilatation bladder to anchor the catheter in the bladder neck of the human body to facilitate correct positioning of the dilatation bladder and minimize the possibility of migration and displacement of the assembly.
  • One or more of the catheter assembly components may be made of radioopague materials to facilitate the visualization of the assembly by the physician during placement of the assembly in the body vessel/conduit.
  • the typical surgical procedure in which the catheter assembly 10 is employed involves the following steps. Normally a cytoscope is first inserted into the vessel/c ⁇ nduit/orifice to be dilated. Calibration devices may be inserted through the cytoscope to facilitate measuring the extent of the vessel/conduit/orifice being dilated. The dilatation catheter of Figure 1 is then inserted to the desired depth in the vessel/conduit. A cytoscope lens may then be inserted through the catheter body to allow visualization of the catheter and the bladder location.
  • Fluid may be infused throug the drainage tube or cytoscope to facilitate such visualiza- tion.
  • the bladder is inflated. Such inflation causes the cutting element to move radially ⁇ utwardly as the bladder surface expands radially until the cutting element contacts the surrounding tissue.
  • tissue is intended to include, without limitation, normal tissue, neoplastic tissue (tumors) or an obstruction such as plaque.
  • tissue is cut in a clean, concentrated fashion by the cutting element and the dilatation does not uncontrollably tear the tissue and cause excessive trauma and bleeding.
  • the inflated bladder provides the additional benefit of acting as a tamponade to reduce bleeding.
  • the bladder is deflated by connecting the inflation/deflation port to suction or atmospheric pres- sure and opening the inflation/deflation port valve thereto. Deflation of the bladder results in a simultane ⁇ ously radial retraction of the cutting element out of contact with the tissue.
  • the cutting element may be retracted via the connector 25. If desired, the element may be retracted prior to complete deflation of the bladder and/or the bladder reinflated and left in place to act as a tampon. Alternatively, the catheter is withdrawn from the vessel/conduit altogether.
  • Figures 3-6 depict another dilatation catheter assembly of the invention, generally designated 29, in use. Only the distal end of the assembly is shown. Adapter(s), inflation/deflation ports are not shown for convenience. • The distal end is defined by a closed end catheter tube 32 which carries an inflatable bladder member 33 on its exterior. The lumen 34 of tube 32 is connected to the source of inflation fluid/suction, as the case may be. The tube has a radial aperture 35 that opens into the lumen 36 of the bladder member. A pair of expandable ring-shaped members 37, 38 extend around the exterior of the bladder member near the distal and proximal ends thereof. One or more cutting elements 39 are affixed between the rings so that they extend longitudinally and outwardly therefrom.
  • Figures 3 (in solid line) and 4 show the as ⁇ sembly in its deflated state positioned within a vessel 42 partially obstructed by an obstruction 43.
  • pressurized fluid is passed through catheter tube lumen 34 and aperture 35 into the bladder lumen.
  • Inflation of the bladder in turn causes the ring members 37, 38 to expand and move the cutting element(s) 39 radially outward.
  • Figures 3 (phantom line), 5, and 6 show the bladder in an inflated state with the cutting element 39 incising the obstruction.
  • FIG. 7 shows yet another dilatation catheter assembly, generally designated 46, of the invention.
  • the assembly is shown in its deflated state.
  • This assembly is similar in structure to assembly 29 except that the assem ⁇ bly is housed within a sheath or introducer 47 and a cauterizing element 48 is connected to the cutting element 39.
  • the sheath permits the assembly to be introduced into the vessel in an unexposed manner, ejected from the end thereof for use, and retracted back into the sheath after use. The ejection and retraction may be achieved by relative longitudinal movement of the sheath, assembly, or both.
  • the heating element permits the cutting element (which in this instance must be made of a heat conducting material) to be heated to a temperature which allows the tissue to be both incised and cauterized.
  • the heating element is connected to a heat source/control, schematically shown at 49.

Abstract

A dilatation catheter assembly (10) which permits simultaneous dilatation and incision of tissue whereby trauma and damage to the tissue due to uncontrolled tearing is reduced or eliminated comprising an elongated tubular body (13) having a distal end that carries a dilatation bladder (15) and a cutting element (17) carried on the exterior of the bladder and that moves radially in concert with the exterior of the bladder as the bladder is inflated and deflated.

Description

DILATATION CATHETER ASSEMBLY WITH CUTTING ELEMENT
Description
Technical Field
The present invention is in the field of surgi¬ cal devices, particularly dilatation catheters. Specif¬ ically- it concerns a dilatation catheter whose expandable member carries a cutting element which concurrently in¬ cises the tissue being subjected to dilatation forces, thereby reducing trauma and damage to such tissue from the dilatation forces.
Background
Dilatation catheters are used to dilate body vessels, orifices and conduits such as an artery narrowed by atherosclerotic plaque and/or fiberomuscular disease or to dilate a constricted or obstructed ureter or urethra. They basically consist of an elongated catheter having an inflatable balloon or bladder at or near its distal end. A guide wire or other axial support means is often included to improve the torque control or "steerability" of the apparatus. The major advantage of dilatation catheter use over conventional surgery is that it is less invasive. Nonetheless, the tissue that is stressed is often also subjected to significant trauma. As the bladder expands, it exerts pressure on the surrounding tissue, causing the tissue to compress, deform and expand. The tissue, of course, has an inherent limit of deformability. When the dilation pressure causes the tissue to deform beyond that limit, the tissue tears apart with considerable damage, trauma, pain, and bleeding. A principal object of the present invention is to provide a dilatation catheter that permits tissue to be stressed, even beyond its limit of deformability, without experiencing uncontrolled tearing and the undesirable conditions associated therewith.
Disclosure of the Invention The invention is a dilatation catheter assembly comprising in combination: an elongated tubular body hav¬ ing a distal end carrying a radially dilatable member adapted to dilate and exert pressure on surrounding body tissue; means for dilating the dilatable member and a cut- ting element carried on the exterior of the dilatable member that moves radially in concert with the exterior of the dilatable member that is adapted to incise said tis¬ sue, thereby reducing damage to said tissue from dilata¬ tion forces. In use the novel catheter of the invention con¬ currently exerts pressure on the tissue and makes a clean, sharp incision in the tissue while the tissue is subjected to the dilatation forces exerted by the dilating member. The incision allows the tissue to separate along a pre- determined path and in a relatively clean, trauma-free manner as compared to the uncontrolled tearing that occurs when using prior devices.
Accordingly, another aspect of the invention is a method for dilating a body conduit, vessel or orifice comprising: inserting thereinto a dilatation catheter assembly comprising an elongated tubular body having a distal end carrying a radially dilatable member adapted to dilate and exert pressure on surrounding body tissue and a cutting element carried on the exterior of the dilatable member; dilating the dilatable member to an extent that causes the tissue to be simultaneously stressed by the dilatable member and incised by the cutting member; radi¬ ally contracting the dilatable member to cause the dilat¬ able member and cutting element to disengage the tissue; and withdrawing the dilatation catheter assembly there- from.
Brief Description of the Drawings
In the drawings, which are not to scale: Figure 1 is a partly cross-sectional, isometric view of one embodiment of the invention catheter.
Figure 2 is a cross-sectional view taken along line 2-2 of Figure 1.
Figure 3 is a perspective, schematic sectional view of a portion of another embodiment of the invention catheter positioned within a body conduit.
Figure 4 is a sectional, side view of the embod¬ iment of Figure 3 in its deflated state.
Figure 5 is a sectional side view of the embodi¬ ment of Figure 3 in its inflated state. Figure 6 is a cross-sectional view along line 6-
6 of Figure 5.
Figure 7 is a sectional elevational view of another embodiment of the invention.
In the drawings like parts are referred to by the same reference numerals.
Detailed Description of the Invention
Figure 1 depicts a dilatation catheter assembly, generally designated 10, that may be used for dilating a body vessel or conduit, such as a ureter or urethra, to treat a blockage or other obstruction. The main elements of catheter assembly 10 are: an adapter 11 that defines the proximal end 12 of the assembly and a site for various ports to the assembly; a catheter body 13 having a triple lumen 14 (Figure 2); an inflatable balloon or bladder member 15; a stiffening stylet 16 that extends longitudinally within one of the three lumens of the catheter body; and a cutting element 17. As seen in Figure 2, one of the three lumens 14 serves as an inflation/deflation passageway 18, a second carries stylet 16 and serves as a drainage/infusion passageway, and a third carries cutting element 17.
The adapter 12 serves as a site for a bladder inflation/deflation port 19 that is attached to a source of inflation medium (not shown) for inflating the bladder or a suction source (not shown) for deflating the bladder. Port 19 has a valve 20 for regulating the inflation medium or suction, as the case may be. Port 19 connects into the proximal end of an inflation/deflation passageway 18 that extends from the port 19 to the bladder. The adapter also serves as a site for the drainage tube inlet/outlet port 22 and a cutting element port 23. The drainage port is connected to the proximal end of the lumen that carries the stylet 16. The drainage port may serve as a site for removing fluid from the lumen or as a site for infusing fluid into the lumen. The distal end of the catheter body has a series of drain holes 24 to facilitate flushing the lumen with fluid or voiding the bladder. A "banana plug" cutting element connector 25 is affixed to the end of the cutting element port and the cutting element extends from the connector through the lumen of the catheter body and exits therefrom via an aperture 26 and continues along the exterior of the bladder. The cutting element consists of a thin wire which has an external incising edge that faces outwardly from the bladder. Alternatively, the cutting element may be a sharp edge, beam, or cauterizing element. The element/bladder is/are constructed (e.g., the element is flexible or expandable) such that the element is car¬ ried on the exterior of the bladder (at least when the bladder is inflated) but is not capable of incising the bladder. If desired, the portion of the exterior of the bladder that is exposed to the element may carry a protec- tive cover (not shown) to further guard against the blad¬ der being incised by the element. The element may be car¬ ried at a predetermined spacing from the bladder surface or directly on the surface. When carried on the surface the element may be an integral part of the surface or at¬ tached to the surface. If desired the cutting element may be extended/retracted manually via the connector into/out of the catheter body.
For use in urethral dilatation the distal end of the assembly includes a coudet tip 27. Such structure may not be necessary or desirable for dilating other conduits/ orifices. For urethral dilation, the assembly may option¬ ally include another lumen and "Foley" type balloon (not shown) distally of the dilatation bladder to anchor the catheter in the bladder neck of the human body to facilitate correct positioning of the dilatation bladder and minimize the possibility of migration and displacement of the assembly.
One or more of the catheter assembly components may be made of radioopague materials to facilitate the visualization of the assembly by the physician during placement of the assembly in the body vessel/conduit. The typical surgical procedure in which the catheter assembly 10 is employed involves the following steps. Normally a cytoscope is first inserted into the vessel/cσnduit/orifice to be dilated. Calibration devices may be inserted through the cytoscope to facilitate measuring the extent of the vessel/conduit/orifice being dilated. The dilatation catheter of Figure 1 is then inserted to the desired depth in the vessel/conduit. A cytoscope lens may then be inserted through the catheter body to allow visualization of the catheter and the bladder location. Fluid may be infused throug the drainage tube or cytoscope to facilitate such visualiza- tion. Once in position, the bladder is inflated. Such inflation causes the cutting element to move radially σutwardly as the bladder surface expands radially until the cutting element contacts the surrounding tissue. As used herein the term "tissue" is intended to include, without limitation, normal tissue, neoplastic tissue (tumors) or an obstruction such as plaque. Continued radial expansion of the bladder positions the cutting element and causes the bladder to exert pressure on the tissue. This combined cutting and dilating action results in the tissue being expanded without being torn due to a buildup of excess stresses within the tissue. Instead, the tissue is cut in a clean, concentrated fashion by the cutting element and the dilatation does not uncontrollably tear the tissue and cause excessive trauma and bleeding. The inflated bladder provides the additional benefit of acting as a tamponade to reduce bleeding.
After the vessel/conduit/orifice tissue is incised and dilated and the blockage/obstruction is relieved, the bladder is deflated by connecting the inflation/deflation port to suction or atmospheric pres- sure and opening the inflation/deflation port valve thereto. Deflation of the bladder results in a simultane¬ ously radial retraction of the cutting element out of contact with the tissue. Once the bladder is deflated the cutting element may be retracted via the connector 25. If desired, the element may be retracted prior to complete deflation of the bladder and/or the bladder reinflated and left in place to act as a tampon. Alternatively, the catheter is withdrawn from the vessel/conduit altogether. Figures 3-6 depict another dilatation catheter assembly of the invention, generally designated 29, in use. Only the distal end of the assembly is shown. Adapter(s), inflation/deflation ports are not shown for convenience. • The distal end is defined by a closed end catheter tube 32 which carries an inflatable bladder member 33 on its exterior. The lumen 34 of tube 32 is connected to the source of inflation fluid/suction, as the case may be. The tube has a radial aperture 35 that opens into the lumen 36 of the bladder member. A pair of expandable ring-shaped members 37, 38 extend around the exterior of the bladder member near the distal and proximal ends thereof. One or more cutting elements 39 are affixed between the rings so that they extend longitudinally and outwardly therefrom.
Figures 3 (in solid line) and 4 show the as¬ sembly in its deflated state positioned within a vessel 42 partially obstructed by an obstruction 43. In order to inflate the bladder, pressurized fluid is passed through catheter tube lumen 34 and aperture 35 into the bladder lumen. Inflation of the bladder in turn causes the ring members 37, 38 to expand and move the cutting element(s) 39 radially outward. Figures 3 (phantom line), 5, and 6 show the bladder in an inflated state with the cutting element 39 incising the obstruction.
Figure 7 shows yet another dilatation catheter assembly, generally designated 46, of the invention. The assembly is shown in its deflated state. This assembly is similar in structure to assembly 29 except that the assem¬ bly is housed within a sheath or introducer 47 and a cauterizing element 48 is connected to the cutting element 39. The sheath permits the assembly to be introduced into the vessel in an unexposed manner, ejected from the end thereof for use, and retracted back into the sheath after use. The ejection and retraction may be achieved by relative longitudinal movement of the sheath, assembly, or both. The heating element permits the cutting element (which in this instance must be made of a heat conducting material) to be heated to a temperature which allows the tissue to be both incised and cauterized. The heating element is connected to a heat source/control, schematically shown at 49. Modifications of the embodiments of the dilata¬ tion/incising catheter assembly described above that are obvious to those of skill in the surgical instruments art are intended to be within the scope of the following claims.

Claims

Claims
1. A dilatation catheter assembly comprising in combination: an elongated tubular body having a distal end carrying a radially dilatable member adapted to dilate and exert pressure on surrounding body tissue, means for dilating the dilatable member, and a cutting element car¬ ried on the exterior of the dilatable member that moves radially in concert with the exterior of the dilatable member that is adapted to incise said tissue, thereby reducing damage to said tissue from dilatation forces.
2. The assembly of claim 1 wherein the dilat¬ able member is an inflatable bladder that is adapted to be connected to a source of inflation fluid.
3. The assembly of claim 1 wherein the cutting element is permanently affixed to the exterior surface of the inflatable member.
4. The assembly of claim 1 wherein the cutting element is removably carried on the exterior of the in¬ flatable member.
5. The assembly of claim 1 wherein the cutting element is an integral component of the dilatable member.
6. The assembly of claim 1 wherein the cutting element comprises a thin wire.
7. The assembly of claim 1 including means for heating the cutting element to a temperature that permits incision and cauterization of the tissue.
8. The assembly of claim 1 including an open ended sheath in which the tubular body is housed and from which the tubular body may be ejected for use and into which the tubular body may be retracted after use.
9. A method for dilating a body conduit, vessel or orifice comprising: inserting thereinto a dilatation catheter assembly comprising an elongated tubular body having a distal end carrying a radially dilatable member adapted to dilate and exert pressure on surrounding body tissue and a cutting element carried on the exterior of the dilatable member; dilating the dilatable member to an extent that causes the tissue to be simultaneously stressed by the dilatable member and incised by the cut¬ ting member; radially contracting the dilatable member to cause the dilatable member and cutting element to dis- engage the tissue; and withdrawing the dilatation catheter assembly therefrom.
10. The method of claim 9 including the step of heating the cutting element while it is in contact with the incised tissue to a temperature that causes said tis¬ sue to be cauterized.
PCT/US1990/000337 1989-01-18 1990-01-18 Dilatation catheter assembly with cutting element WO1990007909A1 (en)

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US298,477 1989-01-18

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Cited By (37)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE4114826A1 (en) * 1991-05-07 1991-12-05 Eckart Dr Miche Opening flap of heart valve - involves wire which is guided by ultrasonic probe
US5196024A (en) * 1990-07-03 1993-03-23 Cedars-Sinai Medical Center Balloon catheter with cutting edge
US5209728A (en) * 1989-11-02 1993-05-11 Danforth Biomedical, Inc. Low profile, high performance interventional catheters
EP0565796A1 (en) * 1992-04-17 1993-10-20 Interventional Technologies Inc Stenosis dilatation device
US5256144A (en) * 1989-11-02 1993-10-26 Danforth Biomedical, Inc. Low profile, high performance interventional catheters
US5295958A (en) * 1991-04-04 1994-03-22 Shturman Cardiology Systems, Inc. Method and apparatus for in vivo heart valve decalcification
EP0600940A1 (en) * 1991-07-24 1994-06-15 Advanced Cardiovascular Systems, Inc. Low profile perfusion-type dilatation catheter
US5324263A (en) * 1989-11-02 1994-06-28 Danforth Biomedical, Inc. Low profile high performance interventional catheters
US5336234A (en) * 1992-04-17 1994-08-09 Interventional Technologies, Inc. Method and apparatus for dilatation of a stenotic vessel
WO1995002370A2 (en) * 1993-07-15 1995-01-26 Aws Shakir Mustafa Salim Tunnelling catheter
WO1995031142A1 (en) 1994-05-11 1995-11-23 Applied Medical Resources Corporation Angioplasty catheter system and method for making
EP0686014A1 (en) * 1993-02-23 1995-12-13 CARDIOVASCULAR & INTERVENTIONAL RESEARCH CONSULTANTS, INC. Thermal balloon angioplasty
EP0721766A1 (en) * 1995-01-10 1996-07-17 Interventional Technologies Inc Vascular incisor/dilator
US5624433A (en) * 1995-04-24 1997-04-29 Interventional Technologies Inc. Angioplasty balloon with light incisor
USRE35523E (en) * 1991-10-11 1997-06-03 Berger; J. Lee Percutaneous carpal tunnel plasty method
WO1997032525A1 (en) * 1996-03-06 1997-09-12 Cardiac Pathways Corporation Apparatus for creating linear lesions by ablation
US5713913A (en) * 1996-11-12 1998-02-03 Interventional Technologies Inc. Device and method for transecting a coronary artery
EP0832608A2 (en) * 1996-09-26 1998-04-01 Interventional Technologies Inc Balloon activated force concentrators for incising stenotic segments
US5895417A (en) * 1996-03-06 1999-04-20 Cardiac Pathways Corporation Deflectable loop design for a linear lesion ablation apparatus
US5997532A (en) * 1997-07-03 1999-12-07 Cardiac Pathways Corporation Ablation catheter tip with a buffer layer covering the electrode
US6010500A (en) * 1997-07-21 2000-01-04 Cardiac Pathways Corporation Telescoping apparatus and method for linear lesion ablation
US6015407A (en) * 1996-03-06 2000-01-18 Cardiac Pathways Corporation Combination linear ablation and cooled tip RF catheters
US6032077A (en) * 1996-03-06 2000-02-29 Cardiac Pathways Corporation Ablation catheter with electrical coupling via foam drenched with a conductive fluid
US6241666B1 (en) 1997-07-03 2001-06-05 Cardiac Pathways Corp. Ablation catheter tip with a buffer layer covering the electrode
US6258108B1 (en) 1996-09-13 2001-07-10 Interventional Technologies, Inc. Incisor-dilator with tapered balloon
US6522930B1 (en) 1998-05-06 2003-02-18 Atrionix, Inc. Irrigated ablation device assembly
US7754047B2 (en) 2004-04-08 2010-07-13 Boston Scientific Scimed, Inc. Cutting balloon catheter and method for blade mounting
US7758604B2 (en) 2003-05-29 2010-07-20 Boston Scientific Scimed, Inc. Cutting balloon catheter with improved balloon configuration
US7780626B2 (en) 2003-08-08 2010-08-24 Boston Scientific Scimed, Inc. Catheter shaft for regulation of inflation and deflation
US7887557B2 (en) 2003-08-14 2011-02-15 Boston Scientific Scimed, Inc. Catheter having a cutting balloon including multiple cavities or multiple channels
US7993358B2 (en) 2005-02-11 2011-08-09 Boston Scientific Scimed, Inc. Cutting balloon catheter having increased flexibility regions
US8038691B2 (en) 2004-11-12 2011-10-18 Boston Scientific Scimed, Inc. Cutting balloon catheter having flexible atherotomes
US8172864B2 (en) 2003-05-12 2012-05-08 Boston Scientific Scimed, Inc. Balloon catheter with improved pushability
CN103949002A (en) * 2014-05-04 2014-07-30 广东博迈医疗器械有限公司 Single-guide wire cutting balloon catheter
US8945047B2 (en) 2004-04-21 2015-02-03 Boston Scientific Scimed, Inc. Traction balloon
US10182841B1 (en) 2015-06-16 2019-01-22 C.R. Bard, Inc. Medical balloon with enhanced focused force control
CN111699016A (en) * 2020-04-30 2020-09-22 广东博迈医疗器械有限公司 Cutting device and cutting balloon

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SU938977A1 (en) * 1980-03-12 1982-06-30 Предприятие П/Я А-3903 Device for dissection of vessels walls
US4747405A (en) * 1984-03-01 1988-05-31 Vaser, Inc. Angioplasty catheter
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Cited By (54)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5209728A (en) * 1989-11-02 1993-05-11 Danforth Biomedical, Inc. Low profile, high performance interventional catheters
US5256144A (en) * 1989-11-02 1993-10-26 Danforth Biomedical, Inc. Low profile, high performance interventional catheters
US5324263A (en) * 1989-11-02 1994-06-28 Danforth Biomedical, Inc. Low profile high performance interventional catheters
US5196024A (en) * 1990-07-03 1993-03-23 Cedars-Sinai Medical Center Balloon catheter with cutting edge
US5320634A (en) * 1990-07-03 1994-06-14 Interventional Technologies, Inc. Balloon catheter with seated cutting edges
US5443446A (en) * 1991-04-04 1995-08-22 Shturman Cardiology Systems, Inc. Method and apparatus for in vivo heart valve decalcification
US5295958A (en) * 1991-04-04 1994-03-22 Shturman Cardiology Systems, Inc. Method and apparatus for in vivo heart valve decalcification
DE4114826A1 (en) * 1991-05-07 1991-12-05 Eckart Dr Miche Opening flap of heart valve - involves wire which is guided by ultrasonic probe
EP0600940A1 (en) * 1991-07-24 1994-06-15 Advanced Cardiovascular Systems, Inc. Low profile perfusion-type dilatation catheter
EP0600940A4 (en) * 1991-07-24 1994-07-20 Advanced Cardiovascular System Low profile perfusion-type dilatation catheter.
USRE35523E (en) * 1991-10-11 1997-06-03 Berger; J. Lee Percutaneous carpal tunnel plasty method
US5336234A (en) * 1992-04-17 1994-08-09 Interventional Technologies, Inc. Method and apparatus for dilatation of a stenotic vessel
EP0565796A1 (en) * 1992-04-17 1993-10-20 Interventional Technologies Inc Stenosis dilatation device
EP0686014A1 (en) * 1993-02-23 1995-12-13 CARDIOVASCULAR & INTERVENTIONAL RESEARCH CONSULTANTS, INC. Thermal balloon angioplasty
EP0686014A4 (en) * 1993-02-23 1996-11-06 Cardiovascular & Interventiona Thermal balloon angioplasty
WO1995002370A3 (en) * 1993-07-15 1995-03-09 Aws Shakir Mustafa Salim Tunnelling catheter
WO1995002370A2 (en) * 1993-07-15 1995-01-26 Aws Shakir Mustafa Salim Tunnelling catheter
WO1995031142A1 (en) 1994-05-11 1995-11-23 Applied Medical Resources Corporation Angioplasty catheter system and method for making
EP0721766A1 (en) * 1995-01-10 1996-07-17 Interventional Technologies Inc Vascular incisor/dilator
US5649941A (en) * 1995-01-10 1997-07-22 Interventional Technologies Inc. Improved vascular incisor/dilator
US5624433A (en) * 1995-04-24 1997-04-29 Interventional Technologies Inc. Angioplasty balloon with light incisor
US5895417A (en) * 1996-03-06 1999-04-20 Cardiac Pathways Corporation Deflectable loop design for a linear lesion ablation apparatus
US6032077A (en) * 1996-03-06 2000-02-29 Cardiac Pathways Corporation Ablation catheter with electrical coupling via foam drenched with a conductive fluid
US6119041A (en) * 1996-03-06 2000-09-12 Cardiac Pathways Corporation Apparatus and method for linear lesion ablation
US6015407A (en) * 1996-03-06 2000-01-18 Cardiac Pathways Corporation Combination linear ablation and cooled tip RF catheters
US5800482A (en) * 1996-03-06 1998-09-01 Cardiac Pathways Corporation Apparatus and method for linear lesion ablation
WO1997032525A1 (en) * 1996-03-06 1997-09-12 Cardiac Pathways Corporation Apparatus for creating linear lesions by ablation
US6258108B1 (en) 1996-09-13 2001-07-10 Interventional Technologies, Inc. Incisor-dilator with tapered balloon
EP0832608A3 (en) * 1996-09-26 1998-04-29 Interventional Technologies Inc Balloon activated force concentrators for incising stenotic segments
EP0832608A2 (en) * 1996-09-26 1998-04-01 Interventional Technologies Inc Balloon activated force concentrators for incising stenotic segments
US5713913A (en) * 1996-11-12 1998-02-03 Interventional Technologies Inc. Device and method for transecting a coronary artery
US5997532A (en) * 1997-07-03 1999-12-07 Cardiac Pathways Corporation Ablation catheter tip with a buffer layer covering the electrode
US6241666B1 (en) 1997-07-03 2001-06-05 Cardiac Pathways Corp. Ablation catheter tip with a buffer layer covering the electrode
US6010500A (en) * 1997-07-21 2000-01-04 Cardiac Pathways Corporation Telescoping apparatus and method for linear lesion ablation
US7959628B2 (en) 1998-05-06 2011-06-14 Atrionix, Inc. Irrigated ablation device assembly
US7276061B2 (en) 1998-05-06 2007-10-02 Atrionix, Inc. Irrigated ablation device assembly
US6522930B1 (en) 1998-05-06 2003-02-18 Atrionix, Inc. Irrigated ablation device assembly
US8617193B2 (en) 2003-05-12 2013-12-31 Boston Scientific Scimed, Inc. Balloon catheter with improved pushability
US8172864B2 (en) 2003-05-12 2012-05-08 Boston Scientific Scimed, Inc. Balloon catheter with improved pushability
US7758604B2 (en) 2003-05-29 2010-07-20 Boston Scientific Scimed, Inc. Cutting balloon catheter with improved balloon configuration
US7780626B2 (en) 2003-08-08 2010-08-24 Boston Scientific Scimed, Inc. Catheter shaft for regulation of inflation and deflation
US7887557B2 (en) 2003-08-14 2011-02-15 Boston Scientific Scimed, Inc. Catheter having a cutting balloon including multiple cavities or multiple channels
US7754047B2 (en) 2004-04-08 2010-07-13 Boston Scientific Scimed, Inc. Cutting balloon catheter and method for blade mounting
US8945047B2 (en) 2004-04-21 2015-02-03 Boston Scientific Scimed, Inc. Traction balloon
US9603619B2 (en) 2004-11-12 2017-03-28 Boston Scientific Scimed, Inc. Cutting balloon catheter having flexible atherotomes
US8361096B2 (en) 2004-11-12 2013-01-29 Boston Scientific Scimed, Inc. Cutting balloon catheter having flexible atherotomes
US8690903B2 (en) 2004-11-12 2014-04-08 Boston Scientific Scimed, Inc. Cutting balloon catheter having flexible atherotomes
US8038691B2 (en) 2004-11-12 2011-10-18 Boston Scientific Scimed, Inc. Cutting balloon catheter having flexible atherotomes
US9017353B2 (en) 2004-11-12 2015-04-28 Boston Scientific Scimed, Inc. Cutting balloon catheter having flexible atherotomes
US7993358B2 (en) 2005-02-11 2011-08-09 Boston Scientific Scimed, Inc. Cutting balloon catheter having increased flexibility regions
CN103949002A (en) * 2014-05-04 2014-07-30 广东博迈医疗器械有限公司 Single-guide wire cutting balloon catheter
US10182841B1 (en) 2015-06-16 2019-01-22 C.R. Bard, Inc. Medical balloon with enhanced focused force control
CN111699016A (en) * 2020-04-30 2020-09-22 广东博迈医疗器械有限公司 Cutting device and cutting balloon
CN111699016B (en) * 2020-04-30 2021-09-03 广东博迈医疗科技股份有限公司 Cutting device and cutting balloon

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