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WO2003039628A2 - Catheter a ballonnet non glissant - Google Patents

Catheter a ballonnet non glissant Download PDF

Info

Publication number
WO2003039628A2
WO2003039628A2 PCT/US2002/036347 US0236347W WO03039628A2 WO 2003039628 A2 WO2003039628 A2 WO 2003039628A2 US 0236347 W US0236347 W US 0236347W WO 03039628 A2 WO03039628 A2 WO 03039628A2
Authority
WO
WIPO (PCT)
Prior art keywords
balloon
vessel
distal end
proximal end
dilatation
Prior art date
Application number
PCT/US2002/036347
Other languages
English (en)
Other versions
WO2003039628A3 (fr
Inventor
Robert C. Farnan
Andrew M. Green
Original Assignee
Novoste Corporation
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 Novoste Corporation filed Critical Novoste Corporation
Priority to AU2002352660A priority Critical patent/AU2002352660A1/en
Publication of WO2003039628A2 publication Critical patent/WO2003039628A2/fr
Publication of WO2003039628A3 publication Critical patent/WO2003039628A3/fr

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
    • A61M25/10—Balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • 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
    • 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
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1086—Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves

Definitions

  • the present invention relates to dilatation balloon catheters of the type employed in percutaneous transluminal angioplasty procedures, and more particularly to dilatation balloons that have a reduced potential of slippage relative to the vessel wall or lesion when inflated in a vessel.
  • a PTA (percutaneous transluminal angioplasty) or PTCA (percutaneous transluminal coronary angioplasty) catheter is used to carry a dilatation balloon to a treatment site, where pressurized fluid is supplied to the balloon to expand the balloon against a stenotic lesion, which is characterized by the build-up of plaque.
  • a stenotic lesion which is characterized by the build-up of plaque.
  • PTA and PTCA balloons that are currently available in the market are designed with a smooth, homogenous surface, and the combination of a smooth balloon surface and the wet environment of a blood vessel creates this potential for balloon slippage. Additionally, when the balloon expands and forces against a more complex lesion (calcified lesion and in-stent restenosis), the lesion is less pliable and the forces exerted back on the balloon can be great enough to cause the balloon to shoot out of the lesion area.
  • Cutting balloons have recently shown clinical efficacy in preventing the reoccurrence of some types of restenosis (specifically calcified lesions and in-stent restenosis).
  • the cutting balloon is a coronary dilatation catheter with 3 to 4 atherotomes (microsurgical blades) bonded longitudinally on the balloon surface.
  • the atherotomes move radially and open the occluded artery by incising and compressing the arterial plaque in a controlled manner.
  • An additional advantage of the cutting balloon is that it maintains its position during inflation by using the metal blades on the external surface of the balloon to penetrate into the tissue and prevent the balloon from moving in relation to the vessel during the dilatation procedure.
  • the primary objective of the present invention is to provide a PTA or PTCA catheter with a non-slip balloon, a balloon with a reduced potential of slipping relative to the vessel wall during the dilatation procedure and further, to provide the advantage of a non- slip balloon without cutting blades or other penetrating means that may severely injure the vessel.
  • the PTA or PTCA balloon is to maintain its initial position during the dilatation procedure.
  • Additional objects of this invention are to provide for better controlled dilatation and gripping of vessel during an angioplasty procedure.
  • Another object of the invention is a balloon with surface characteristics to reduce balloon slipping or longitudinal movement relative to the vessel during dilatation.
  • the surface of a balloon can be textured with bumps, knurls, ridges, dimples, cords, raised areas, spirals, etc. arrange in any possible pattern.
  • a further object is to provide such balloons which, because of their exterior features, can be used in angioplasty procedures with a greater probability of success.
  • a further object of the invention is to provide such balloons with surface characteristics molded therein.
  • Fig. 1 is a perspective view of an angioplasty balloon catheter incorporating a non-slip balloon according to the present invention.
  • Fig. 2 is a perspective view of the non-slip balloon in its expanded state.
  • Fig. 3 is a perspective view showing a further embodiment of the present invention.
  • Figs. 4a-h are top and side views of alternate embodiments of the non-slip balloon of the present invention.
  • the present invention relates to balloons for percutaneous transluminal angioplasty (PTA), wherein a catheter with a balloon at the distal end is positioned within a bodily vessel or conduit and inflated to expand the vessel or conduit.
  • PTA percutaneous transluminal angioplasty
  • PTCA percutaneous transluminal coronary angioplasty
  • the dilatation catheter 10 incorporates a balloon 20 having surface characteristics that will prevent the balloon movement in relation to the vessel when the balloon is inflated during an angioplasty procedure. More specifically, a preferred embodiment of the present invention is shown in Figure 1.
  • Figure 1 displays a PTCA catheter 10 (could be a PTA catheter as well) with a unique balloon 20 having ribbed protrusions 22 incorporated therein.
  • the catheter 10 includes a shaft 12 having a proximal section 14, a distal section 16 and an intermediate section 18 therebetween.
  • the distal end of the distal section 16 may include a taper and be slightly smaller in diameter than the rest of the shaft 12.
  • a dilatation balloon 20 is affixed to the distal section 16 of the catheter shaft 12, and a luer hub 13 for insertion of the guide wire (not shown) and connection of an inflation media (not shown) is located at the proximal end of the catheter 10.
  • Extending distally a short distance from the proximal end of the catheter 10 and retained at one end by the luer hub 13 is a strain relief tube 15to prevent kinking of the catheter portion that remains outside the patient and is most susceptible to stresses and bends.
  • the catheter 10 can be of a coaxial design having an inner tube with a guide wire lumen and an outer tube with a balloon inflation lumen or can be composed of a multi-lumen tube having both guide wire and balloon inflation lumens extruded within a single tube.
  • the inflation lumen is fluidly connected to the balloon 20 for the introduction/removal of inflation media for the inflation and deflation of the balloon 20 attached to the distal end of the catheter shaft 12.
  • Any of the inner, outer or multi-lumen tube can be composed of up to three layers of material and can be reinforced with braids.
  • the catheter 10 shall be compatible with standard guide catheters or introducer sheaths.
  • the dilatation balloon 20 of the present invention incorporates a knurled surface for increased interference between the balloon 20 and the vessel wall or lesion so as to maintain the balloon 20, as initially placed by the ftiterventional Cardiologist, at the lesion to be treated.
  • the preferred knurled surface is a series of raised ridges or ribs 22 in a crisscross or braid like pattern molded into the working length 24 of the balloon, as seen in Figure 2.
  • the crisscross surface pattern of the balloon 20 shown in Figure 2 is a result of four integrated ribs 22 spiraled around the perimeter of the balloon 20. Each integrated rib 22 begins at one end of the balloon working length 24 and ends at the other end of the balloon working length 24.
  • the balloon molded ribs 22 have identical coil pitches, but each of their starting points are radially spaced 90 degrees apart at one end of the balloon working length 24, and each of their ending points are radially spaced 90 degrees apart at the other end of the balloon working length 24.
  • the elongated ribs 22 intersect to create X's radially and longitudinally along the working length 24 of the balloon 20.
  • the points of intersection 26 are preferably spaced 10 mm apart along each individual plane and 5 mm apart in different planes. The spacing or pitch does not necessarily change with balloon length; there will just be more crisscrosses and points of intersection 26 with longer balloon lengths. These points of intersection 26 are most crucial in creating interference between the balloon 20 and the vessel as they come into contact during inflation.
  • the crisscross intersections can be spaced closer together to create more points of intersection 26 and thus, increased interference to reduce balloon slipping.
  • the points of intersection 26 may also create natural folds in the balloon 20 for neatly folding the deflated balloon 20 around the catheter shaft 12.
  • the "knurl” pattern may range from as close as .1 inch up to 1 inch in spacing.
  • the preferred depth (protrusion) of "knurl” is from .005 inch to .015 inch with a phase ⁇ ranging from .010 inch to .030 inch.
  • any of 1, 2, 4, 8, and 16 integrated rib members 22 may be spiraled around the periphery of the balloon 20.
  • One member will create a spring coil pattern 32 as seen in Figure 3.
  • Two rib members will be spaced 180 degrees apart, eight rib members will be spaced 45 degrees apart and sixteen members will be spaced 22.5 degrees apart.
  • Dilatation balloons can be made from a variety of known materials and can be fabricated to be assembled on either a coaxial or multi-lumen catheter platform. Considerable art is already available on the use of balloon catheters and their fabrication. The preference for material selection is along the line of a high pressure, non-compliant material (such as PET or polyethylene terrathalate) or a semi-compliant, puncture resistant material (such as nylon).
  • a tacky coating (such as urethane) may be applied to the outer surface to enhance the frictional coefficient and aid in the deflation of the balloon. The coating can be selectively added to certain areas of the balloon, such as just the ribs.
  • the balloon 20 can be a multi-layered balloon with a non-compliant inner layer to a most compliant outer layer.
  • a most inner layer of PET which provides a higher pressure balloon
  • an outer layer of nylon which provides a more puncture resistant surface.
  • Ribs are not separate layer unless separate member adhered to balloon surface.
  • urethane can be added as a top layer in multi-layered blowing.
  • the balloon 20 may be from 1.5-12 mm in diameter (1.5 - 4 mm for coronary and 4-12 for peripheral vessels) (the diameter of the balloon 20 is the minor diameter of the balloon 20 and does not include the ribs 22 in the dimension) and 15-60 mm in length (15-40mm for coronary and up to 60mm for peripheral vessels).
  • the balloon inflation pressure will be form 8-20 atmospheres depending on the wall thickness of the balloon 20.
  • the dilatation balloon 20 is made using conventional balloon molding operations and additional pre and post molding operations.
  • the balloon making process includes (1) extruding a tubular parison of the chosen balloon material or materials; (2) positioning the tubular parison of material into a blow molding machine and conducting the blow molding operations, which include (a) heating the tubular parison of material to a certain transition temperature and longitudinally expanding or stretching the tubing; (b) inflating the balloon within the mold, which defines the dimensions and certain physical characteristics of the balloon; (c) possibly more longitudinal expanding of the balloon; (d) having the balloon reach its crystallizing temperature for effectively locking the molecular structure in place; and (e) cooling down the mold and the balloon inside the mold.
  • the surface characteristics of the balloon take the shape of the mold.
  • the dilatation balloon 20 is affixed to the distal section 16 of an elongated flexible tubular catheter 10.
  • its working length 24, i.e., its medial section exhibits a diameter substantially larger than that of the catheter shaft 12 on which it is mounted.
  • the proximal and distal stems 28 and 29 of the balloon 20 have diameters substantially equal to the diameter of the catheter body.
  • Proximal and distal tapered sections 30 and 31, referred to herein as "spheres" or “cones”, join the medial section 24 to the proximal and distal stems 28 and 29, respectively. Each sphere or cone diverges in the direction toward the medial section 24.
  • Fusion bonds or UN adhesives between the proximal and distal balloon stems 28 and 29 and the catheter form a fluid- tight seal to facilitate dilation of the balloon 20 when a fluid under pressure is introduced into it, via an inflation port formed through the wall of the catheter and in fluid communication with the inflation lumen of the catheter.
  • the balloon 20 can be molded to have other surface characteristics, such as small spheres, dimples, elongated rods, spirals, and cords, that will increase friction or interference between the balloon 20 and the vessel and reduce balloon slipping.
  • the raised surface characteristics may be created in the balloon material itself through the addition of carbon or Kevlar fibers in the material matrix.
  • FIG. 4 Another alternative can be seen in Figure 4 and has elements of certain shapes, such as spheres or rods, trapped between the balloon material layers.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention porte sur un ballonnet de dilatation présentant des caractéristiques de surface qui permettent de réduire le potentiel de glissement du ballonnet gonflé par rapport à la paroi du vaisseau sanguin qu'on est en train de traiter. Le ballonnet comprend une série de parties saillantes allongées en forme de ruban qui sont moulées dans celui-ci. Les parties saillantes en forme de ruban sont disposées selon une configuration entrecroisée et forment des points d'intersection le long du ballonnet. Ces points d'intersection créent une interférence entre le ballonnet et le vaisseau au moment où ils viennent en contact pendant le gonflage, et l'interférence augmentée génère une réduction du potentiel de glissement du ballonnet lorsqu'il est à l'état gonflé dans un vaisseau. Selon d'autres formes d'exécution, le ballonnet peut être pourvu d'une saillante en forme de ruban enroulée en spirale. D'autres ballonnets peuvent présenter des caractéristiques de surfaces diverses telles que des renflements, des molettes, des cannelures, des dépressions, des crêtes et des zones en relief.
PCT/US2002/036347 2001-11-09 2002-11-12 Catheter a ballonnet non glissant WO2003039628A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2002352660A AU2002352660A1 (en) 2001-11-09 2002-11-12 Balloon catheter with non-slip balloon

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US34589401P 2001-11-09 2001-11-09
US60/345,894 2001-11-09

Publications (2)

Publication Number Publication Date
WO2003039628A2 true WO2003039628A2 (fr) 2003-05-15
WO2003039628A3 WO2003039628A3 (fr) 2003-10-30

Family

ID=23356976

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2002/036347 WO2003039628A2 (fr) 2001-11-09 2002-11-12 Catheter a ballonnet non glissant

Country Status (2)

Country Link
AU (1) AU2002352660A1 (fr)
WO (1) WO2003039628A2 (fr)

Cited By (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005014099A1 (fr) 2003-07-14 2005-02-17 Scimed Life Systems, Inc. Ballon ancrable utilise a des fins d'angioplastie, et son procede de production
US7686824B2 (en) 2003-01-21 2010-03-30 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
US8080026B2 (en) 2003-01-21 2011-12-20 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
WO2012058423A1 (fr) 2010-10-27 2012-05-03 Cook Medical Technologies Llc Cathéter à ballonnet pour valvuloplastie
US20130138134A1 (en) * 2010-05-13 2013-05-30 Noel M. Elman Stent devices for support, controlled drug delivery and pain management after vaginal surgery
US9067045B2 (en) 2008-07-25 2015-06-30 Cook Medical Technologies Llc Balloon catheter and method for making same
US9173977B2 (en) 2010-04-19 2015-11-03 Angioscore, Inc. Coating formulations for scoring or cutting balloon catheters
US9351756B2 (en) 2010-09-21 2016-05-31 Angioscore, Inc. Method and system for treating valve stenosis
US9375328B2 (en) 2001-11-09 2016-06-28 Angioscore, Inc. Balloon catheter with non-deployable stent
US9586031B2 (en) 2005-05-11 2017-03-07 Angioscore, Inc. Methods and systems for delivering substances into luminal walls
US20180256863A1 (en) * 2014-05-13 2018-09-13 Cook Medical Technologies Llc Medical balloon assembly and method of making a medical balloon
US10086178B2 (en) 2001-11-09 2018-10-02 Angioscore, Inc. Balloon catheter with non-deployable stent
US10117668B2 (en) 2013-10-08 2018-11-06 The Spectranetics Corporation Balloon catheter with non-deployable stent having improved stability

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6129706A (en) * 1998-12-10 2000-10-10 Janacek; Jaroslav Corrugated catheter balloon

Cited By (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9375328B2 (en) 2001-11-09 2016-06-28 Angioscore, Inc. Balloon catheter with non-deployable stent
US11571554B2 (en) 2001-11-09 2023-02-07 Angioscore, Inc. Balloon catheter with non-deployable stent
US10086178B2 (en) 2001-11-09 2018-10-02 Angioscore, Inc. Balloon catheter with non-deployable stent
US8454636B2 (en) 2003-01-21 2013-06-04 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
US8080026B2 (en) 2003-01-21 2011-12-20 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
US10722694B2 (en) 2003-01-21 2020-07-28 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
US8721667B2 (en) 2003-01-21 2014-05-13 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
US7686824B2 (en) 2003-01-21 2010-03-30 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
US9962529B2 (en) 2003-01-21 2018-05-08 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
US7955350B2 (en) 2003-01-21 2011-06-07 Angioscore, Inc. Apparatus and methods for treating hardened vascular lesions
JP2007518448A (ja) * 2003-07-14 2007-07-12 ボストン サイエンティフィック リミテッド 血管形成術のための固定可能なバルーン及び製造方法
WO2005014099A1 (fr) 2003-07-14 2005-02-17 Scimed Life Systems, Inc. Ballon ancrable utilise a des fins d'angioplastie, et son procede de production
US11420030B2 (en) 2005-05-11 2022-08-23 Angioscore, Inc. Methods and systems for delivering substances into luminal walls
US10342960B2 (en) 2005-05-11 2019-07-09 Angioscore, Inc. Methods and systems for delivering substances into luminal walls
US10076641B2 (en) 2005-05-11 2018-09-18 The Spectranetics Corporation Methods and systems for delivering substances into luminal walls
US9586031B2 (en) 2005-05-11 2017-03-07 Angioscore, Inc. Methods and systems for delivering substances into luminal walls
US9861797B2 (en) 2008-07-25 2018-01-09 Cook Medical Technologies Llc Balloon catheter and method for making same
US10646698B2 (en) 2008-07-25 2020-05-12 Cook Medical Technologies Llc Balloon catheter and method for making same
US9067045B2 (en) 2008-07-25 2015-06-30 Cook Medical Technologies Llc Balloon catheter and method for making same
US9173977B2 (en) 2010-04-19 2015-11-03 Angioscore, Inc. Coating formulations for scoring or cutting balloon catheters
US10314947B2 (en) 2010-04-19 2019-06-11 Angioscore, Inc. Coating formulations for scoring or cutting balloon catheters
US10471184B2 (en) 2010-04-19 2019-11-12 Angioscore, Inc. Coating formulations for scoring or cutting balloon catheters
US20130138134A1 (en) * 2010-05-13 2013-05-30 Noel M. Elman Stent devices for support, controlled drug delivery and pain management after vaginal surgery
US9351756B2 (en) 2010-09-21 2016-05-31 Angioscore, Inc. Method and system for treating valve stenosis
US9364254B2 (en) 2010-09-21 2016-06-14 Angioscore, Inc. Method and system for treating valve stenosis
US10736652B2 (en) 2010-09-21 2020-08-11 Angioscore, Inc. Method and system for treating valve stenosis
US8685054B2 (en) 2010-10-27 2014-04-01 Cook Medical Technologies Llc Valvuloplasty balloon catheter
WO2012058423A1 (fr) 2010-10-27 2012-05-03 Cook Medical Technologies Llc Cathéter à ballonnet pour valvuloplastie
US10117668B2 (en) 2013-10-08 2018-11-06 The Spectranetics Corporation Balloon catheter with non-deployable stent having improved stability
US10485571B2 (en) 2013-10-08 2019-11-26 Angioscore, Inc. Balloon catheter with non-deployable stent having improved stability
US20180256863A1 (en) * 2014-05-13 2018-09-13 Cook Medical Technologies Llc Medical balloon assembly and method of making a medical balloon

Also Published As

Publication number Publication date
WO2003039628A3 (fr) 2003-10-30
AU2002352660A1 (en) 2003-05-19

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