EP1204441A2 - Procede de fonctionnement d'un dispositif de dilatation et dispositif de dilatation correspondant - Google Patents

Procede de fonctionnement d'un dispositif de dilatation et dispositif de dilatation correspondant

Info

Publication number
EP1204441A2
EP1204441A2 EP00979465A EP00979465A EP1204441A2 EP 1204441 A2 EP1204441 A2 EP 1204441A2 EP 00979465 A EP00979465 A EP 00979465A EP 00979465 A EP00979465 A EP 00979465A EP 1204441 A2 EP1204441 A2 EP 1204441A2
Authority
EP
European Patent Office
Prior art keywords
pressure
balloon
dilatation
dilatation catheter
generator
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Withdrawn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
EP00979465A
Other languages
German (de)
English (en)
Inventor
Hermann Monstadt
Gerd Hausdorf
H. Krause
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.)
Dendron GmbH
Original Assignee
Dendron GmbH
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 Dendron GmbH filed Critical Dendron GmbH
Publication of EP1204441A2 publication Critical patent/EP1204441A2/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Withdrawn legal-status Critical Current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
    • A61M25/10—Balloon catheters
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10181—Means for forcing inflation fluid into the balloon
    • A61M25/10182—Injector syringes
    • 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
    • A61M25/1018—Balloon inflating or inflation-control devices
    • A61M25/10184—Means for controlling or monitoring inflation or deflation
    • A61M25/10185—Valves

Definitions

  • the present invention relates to a method for operating a balloon dilatation catheter, which has a balloon catheter with an expandable dilatation balloon which is pressurized with pressure medium by a pressure generator via a pressure line.
  • the invention relates to a balloon dilatation catheter with a pressure generator for generating hydraulic pressure medium, which is connected to a dilatation balloon via a pressure line, for carrying out the aforementioned method.
  • the surgical method is known to widen the stenotic area by means of a dilatation catheter.
  • balloon catheters are used to carry out the dilatation, in which an expandable dilatation balloon is arranged at the distal end of a pressure tube.
  • An embodiment of such a balloon catheter is described, for example, in DE 195 33 601 A1.
  • this dilatation balloon is inserted directly into the stenotic section. There it is filled with pressure medium by a pressure generator, for example hydraulically with liquid or pneumatically with gas.
  • a pressure generator for example hydraulically with liquid or pneumatically with gas.
  • the pressure of this pressure medium is set to a predefined, constant value in order to ensure that the resulting dilatation force is exerted on the surrounding tissue to expand this stenotized vessel.
  • a working pressure between 6 and 12 bar is specified.
  • dilatation balloons with adapted expansion properties are used for different types and properties of stenoses.
  • all of the forms of dilatation catheters have in common the aforementioned operating method, namely the one-time dilatation by exposure to pressure medium under static working pressure. This also causes a static expansion of the narrowed vessel lumen in the area of the dilatation balloon.
  • Another application is the implantation of stents (vascular supports) with the help of dilatation balloons, which absorb the restoring forces of the surrounding tissue and in this way fix the lumen enlargement.
  • This static balloon dilation enables the application of stents, but at the same time has a number of disadvantages which result from the operating method of the balloon catheter.
  • the localized tear in the surrounding tissue produced by the static force can namely be the starting point for tearing through the entire wall and thus trigger a rupture or perforation. With blood vessels, bleeding from the vessel would be inevitable in this case. Wall weakness may also develop and aneurysms may subsequently develop.
  • Another risk of localized cracks is the dissection of individual wall layers, which either close the lumen themselves or indirectly lead to the laying of the lumen by activating the coagulation on the wall tear.
  • the present invention is based on the object of specifying a method for operating a balloon dilatation catheter and a dilatation catheter for carrying out this method, which enable the balloon dilatation to be carried out more gently and more tolerably.
  • the invention proposes a method for operating a balloon dilatation catheter, in which the dilatation balloon is dynamically acted upon with pressure medium with oscillating pressure.
  • the special feature of the operating method according to the invention is that the dilatation balloon is connected to a dynamically pulsating pressure generator which emits a sequence of hydraulic or pneumatic pressure pulses.
  • the expansion in the invention is additionally pulsed or oscillating.
  • the dilatation balloon is initially actively filled with pressure medium, so that it widens up to the apex of the pressure pulse.
  • pressure medium is again actively drawn out of the dilatation balloon until the lower apex is reached, so that its volume is reduced by the oscillation volume.
  • the pressure oscillation is consequently immediately converted into a periodic expansion and contraction of the dilatation balloon.
  • the oscillating pressure according to the invention is preferably static
  • Base pressure overlaid.
  • the dilatation balloon can be preloaded with defined force conditions.
  • the pulsating pressure is modulated so that a corresponding periodically changing force is exerted.
  • the stationary base pressure can be set variably, including over the treatment time. This also applies to the relationship between base pressure and oscillating pressure.
  • guideline values for the oscillation frequency between 0.5 and 50 Hz can be selected, while the pressure amplitude can be between 0.1 and 2 bar.
  • the particular advantage of the operating method according to the invention for a balloon dilatation catheter is that an oscillating force effect on the surrounding tissue is achieved by the oscillating pressure changes.
  • an alternating force acts on the surrounding tissue, and thus also in the stenotic area.
  • Stretchable balloons are also excited by the pressure oscillations themselves to diameter or volume oscillations. An alternating expansion of the surrounding tissue is thus achieved.
  • the oscillating, periodically changing force acts intermittently on the surrounding tissue, which results in a much more gentle expansion due to the given viscoelastic properties of the body tissue.
  • This form of force action causes a periodic, intermittent energy transfer, whereby the tensile stress of the tissue is not reached by the individual impulses, but rather a quasi-continuous expansion takes place due to the pulsating energy transfer to the tissue due to its viscoelastic and plastic properties.
  • the particular advantage is that tearing of the tissue, which can lead to rupture and perforation, is practically excluded.
  • the operating method according to the invention transmits kinetic energy to the surrounding biological tissue through the oscillation in addition to the static pressure. Due to the associated physiological effects, the expansion can be done with significantly less Expansion forces, i.e. static dilation pressures occur. In other words, this means that stenoses can be widened without the tensile stress of the
  • Tissue surrounding the dilatation balloon is exceeded, as is the case in principle with conventional dilatation methods.
  • the quasi-continuous expansion with lower maximum pressures is made possible in the method according to the invention by the fact that the oscillations generate micro-traumas or micro-tears in the vessel wall which, because of the uniform, additional introduction of energy, enable the lumen to be effectively expanded without the risk of wall rupture consists.
  • the method according to the invention is particularly advantageous for the implantation of balloon-expandable stents, which are pressed into the surrounding tissue with a very high static force in conventional methods, namely with special balloon catheters, which are fed with extremely high pressure - up to 20 bar. Thanks to the oscillating dilation that can be used with the operating method according to the invention, a corresponding force is exerted on the stent, so that the stent can be expanded and implanted at significantly lower maximum pressures.
  • a balloon dilatation catheter for performing the aforementioned method, with a pressure generator for generating hydraulic pressure medium, which is connected via a pressure line to a dilation balloon, is characterized according to the invention in that the pressure generator has a hydraulic pulsation device, of which the dilation balloon with oscillating hydraulic Pressure pulses can be applied.
  • a static pressure generator is preferably connected in parallel with the pulsation device and supplies a stationary base pressure which is pulsed by the pressure pulses.
  • the pulsation device has a piston syringe, the piston of which can be driven by an oscillation device.
  • This oscillation device can be designed, for example, as a pneumatic or electro-mechanical pulse generator, which periodically moves the plunger of the plunger syringe back and forth alternately with respect to the syringe cylinder, so that the pressure medium is pressed or pulled out into the dilatation balloon. The oscillating movement of the syringe plunger is consequently immediately transformed into an oscillating movement of the dilatation balloon.
  • the latter has a double-acting pneumatic cylinder which can be pressurized with compressed gas via a remotely controllable control valve.
  • the pneumatic cylinder forms a piston-cylinder unit, the piston of which is mechanically coupled to the piston of the piston syringe and can be precisely controlled by controlled intake of compressed air via the control valve with regard to piston stroke, force exerted and oscillation frequency.
  • the oscillating pressure medium volume is actively moved into and out of the oscillating balloon by the movement of the piston, so that the oscillation of the balloon is independent of the restoring force of the stretched balloon or of the surrounding tissue.
  • the pulse generator preferably contains a pressure regulator with a control circuit which detects the hydraulic pressure in the system via hydraulic pressure sensors and controls the control valve as a function thereof.
  • the control loop can be designed as an open or closed pressure control loop. While the open pressure control loop is particularly well suited for high oscillation frequencies, the closed pressure control loop enables high-precision control of the pressure in the dilatation balloon.
  • the hydraulic pressure in the system is detected via the pressure sensor and the measured value is sent to, for example
  • the oscillation device is preferably designed as a quartz oscillator. In order to control the pulsation device, resonant vibrations for the amplitude build-up of the oscillation and antiphase vibrations for the amplitude reduction are excited.
  • the static pressure generator which is hydraulically connected in parallel with the pulsation device, is preferably designed as a balloon inflation syringe. This is preferably a manually operated syringe.
  • the static hydraulic working pressure of the dilatation balloon is set manually by means of this static pressure generator, as is known from the conventional balloon dilatation.
  • the static pressure is variably adjustable and can be specified independently of the pulsatory pressure of the pulse generator. This has the additional advantage that in the event of a possible failure of the pulse generator, the dilation can still be carried out conventionally.
  • the dilatation balloon, the pressure line, the plunger syringe and the balloon inflation syringe are preferably disposable products provided sterile. This means that all components that come into contact with the patient are already in sterile form and can be used or replaced quickly and easily during use.
  • the pulsation device, that is the pulse generator, does not come into contact with the pressure medium and therefore does not have to be sterilized.
  • Figure 1 is a schematic representation of a device according to the invention.
  • Figure 2 is an illustration of a pneumatic
  • Pulse generator according to the invention.
  • FIG. 1 shows a schematic functional diagram of a balloon dilatation catheter according to the invention, which as a whole is provided with the reference number 1.
  • This has a pneumatic pressure source 2, one on it connected proportional valve 3 and a control valve 4, which controls a pneumatic pulse generator 5, which consists of a pneumatic cylinder 5a and a piston syringe 5b mechanically coupled therewith.
  • the hydraulic pressure lines drawn in bold, connect to the piston syringe 5b and lead to the dilatation balloon 6 via the catheter.
  • a balloon inflation syringe 7 and an electrical pressure sensor 8 are also connected to it.
  • the pressure sensor 8 is connected to a PI controller 9 via an electrical control line (shown in dashed lines). This controls the proportional valve 3, the maximum pressure being adjustable as the setpoint input 10 as the setpoint.
  • the control valve 4 which is designed, for example, as a 5/3-way valve, is periodically activated via a control unit 11.
  • the static pressure in the dilatation balloon 6 is first set manually using the balloon inflation syringe 7 and is monitored, for example, by the pressure sensor 8.
  • the actuation frequency of the control valve 4 which corresponds to the pulse frequency of the pneumatic pulse generator 5, is set on the control unit 11.
  • the resulting actuation of the pneumatic cylinder 5a actuates the plunger syringe 5b, which ensures that a pulsatory pressure is fed into the dilatation balloon 6.
  • a high-precision control of the balloon pressure takes place via the closed control loop with the pressure sensor 8, the regulator 9 and the proportional valve 3.
  • FIG. 2 shows the structure of the pneumatic pulse generator 5 with the double-acting pneumatic cylinder 5a and the piston syringe 5b in a particularly clear manner.
  • This is a sterile disposable piston syringe, the syringe piston of which is detachably coupled to the piston of the pneumatic cylinder 5a by means of a connecting piece 12.
  • the balloon inflation point 7, which is similar in structure to the piston syringe 5b, is over via a 3-way valve 13 a pressure hose shown schematically connected to the dilatation balloon 6.

Landscapes

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

Abstract

L'invention concerne un procédé de fonctionnement d'un cathéter de dilatation à ballonnet, lequel présente un cathéter à ballonnet doté d'un ballonnet extensible alimenté en agent de pression par un générateur de pression via une conduite de pression. Pour permettre une dilatation plus délicate et mieux tolérée du ballonnet, notamment une dilatation qui évite de blesser le tissu environnant, le ballonnet est alimenté de façon dynamique en agent de pression par pression oscillante. L'invention concerne également un cathéter de dilatation à ballonnet permettant de mettre en oeuvre ce procédé.
EP00979465A 1999-07-31 2000-07-31 Procede de fonctionnement d'un dispositif de dilatation et dispositif de dilatation correspondant Withdrawn EP1204441A2 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
DE19936162A DE19936162A1 (de) 1999-07-31 1999-07-31 Verfahren zum Betrieb einer Dilatationsvorrichtung und Dilatationsvorrichtung zur Durchführung des Verfahrens
DE19936162 1999-07-31
PCT/EP2000/007414 WO2001010491A2 (fr) 1999-07-31 2000-07-31 Procede de fonctionnement d'un dispositif de dilatation et dispositif de dilatation correspondant

Publications (1)

Publication Number Publication Date
EP1204441A2 true EP1204441A2 (fr) 2002-05-15

Family

ID=7916800

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00979465A Withdrawn EP1204441A2 (fr) 1999-07-31 2000-07-31 Procede de fonctionnement d'un dispositif de dilatation et dispositif de dilatation correspondant

Country Status (3)

Country Link
EP (1) EP1204441A2 (fr)
DE (1) DE19936162A1 (fr)
WO (1) WO2001010491A2 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019200201A1 (fr) 2018-04-12 2019-10-17 The Regents Of The University Of Michigan Système pour effectuer et commander une pression oscillatoire à l'intérieur de cathéters à ballonnet pour fracture de fatigue de calculs
EP4288136A4 (fr) 2021-02-04 2024-08-07 Amplitude Vascular Systems, Inc. Systèmes de cathéter à ballonnet pulsatile et leurs procédés d'utilisation

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4271839A (en) * 1979-07-25 1981-06-09 Thomas J. Fogarty Dilation catheter method and apparatus
DE3138620A1 (de) * 1981-09-29 1983-04-14 Adolf Dr.med. Ing.(grad.) 3000 Hannover Kuhl Dilatationsvorrichtung
US4446867A (en) * 1981-12-31 1984-05-08 Leveen Robert F Fluid-driven balloon catheter for intima fracture
CA2118886C (fr) 1993-05-07 1998-12-08 Dennis Vigil Methode et dispositif de dilatation de vaisseaux stenoses
US5472424A (en) * 1994-04-05 1995-12-05 Merit Medical Systems, Inc. Syringe with volume displacement apparatus
US5545133A (en) 1994-09-16 1996-08-13 Scimed Life Systems, Inc. Balloon catheter with improved pressure source
DE69513506T2 (de) * 1995-05-26 2000-03-30 Schneider (Europe) Gmbh, Buelach Ein pulsiertes Strömungsmedium anwendendes Stentausdehnungssystem
US5885244A (en) * 1997-05-14 1999-03-23 Cordis Corporation & University Of Miami Synchronous, pulsatile angioplasty system

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0110491A2 *

Also Published As

Publication number Publication date
WO2001010491A3 (fr) 2001-10-04
WO2001010491A2 (fr) 2001-02-15
DE19936162A1 (de) 2001-02-01

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