Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—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
  • 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
  • A61M25/0067—Catheters; Hollow probes characterised by the distal end, e.g. tips
  • A61M25/0068—Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• • 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
  • 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
• • 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
  • 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
  • A61B2017/22065—Functions of balloons
• • 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
  • A61B2017/22072—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 instrument channel, e.g. for replacing one instrument by the other
  • A61B2017/22074—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 instrument channel, e.g. for replacing one instrument by the other the instrument being only slidable in a channel, e.g. advancing optical fibre through a channel
• • 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
  • A61B2017/22079—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 suction of debris
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
  • A61B2017/22082—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
  • A61B2017/22084—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2217/00—General characteristics of surgical instruments
  • A61B2217/002—Auxiliary appliance
  • A61B2217/005—Auxiliary appliance with suction drainage system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B2217/00—General characteristics of surgical instruments
  • A61B2217/002—Auxiliary appliance
  • A61B2217/007—Auxiliary appliance with irrigation system
• • 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
  • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
  • A61M2025/0042—Microcatheters, cannula or the like having outside diameters around 1 mm or less
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M2025/0183—Rapid exchange or monorail 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
  • A61M25/10—Balloon catheters
  • A61M25/1002—Balloon catheters characterised by balloon shape
  • A61M2025/1004—Balloons with folds, e.g. folded or multifolded
• • 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
  • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Definitions

• IDAC Infusion, Dilatation and Aspiration Catheter
• aspiration catheters It is known to remove thrombi or thrombotic material from blood vessels by means of so-called aspiration or suction catheters.
• the aspiration catheter is introduced and guided to the thrombotic site. Subsequently thrombotic material can be removed from the blood vessel via the aspiration catheter.
• the aspiration catheter is advanced for this purpose until its distal end reaches the area from which thrombotic material is to be aspirated.
• the material is now aspirated through the lumen of the suction catheter, e.g. using a Luer Lock syringe.
• a disadvantage of this method and the catheters designed for this purpose is that the thrombotic material agglomerated in the blood vessel may under certain circumstances be difficult to detach from the vessel wall.
• the detached agglomerates can be relatively bulky, so that a targeted suction through the aspiration catheter can be difficult.
• infusion catheters are known, by means of which saline solutions (saline solutions) for rinsing or medicaments (for example thrombolytic drugs) are supplied in order to remove dissolved thrombotic material or to dissolve thrombotic material (debris / plaque) from the vessel wall.
• saline solutions saline solutions
• medicaments for example thrombolytic drugs
• a disadvantage of these techniques is that, on the one hand, the effect of the medicament administered by a conventional infusion catheter, eg a microcatheter, which essentially consists of a lumen with a distal opening, is low due to dilution effects. For that reason, on the other hand, a large amount must be be supplied to the drug. However, the uncontrolled drug or detached thrombi may enter other areas of the bloodstream under these circumstances, which can lead to significant side effects such as strokes.
• the object of the invention is to provide a catheter which solves the problems mentioned and ensures a rapid and uncomplicated removal of thrombotic material.
• the system for removing thrombotic material from a blood vessel comprises an aspiration catheter and an infusion element, the infusion element having a delivery catheter for delivering a fluid and an expandable balloon connected to the delivery catheter, the balloon having openings and / or at least one (semi ) permeable wall portion for passage of the fluid, wherein the infusion member is movably receivable in a first lumen of the aspiration catheter and movable therethrough.
• the problem with conventional systems is that when a thrombolytic drug is delivered to a thrombotic vessel, incompletely dissolved thrombotic material and / or debris / plaque may be transported on, and may be elsewhere, e.g. can cause a stroke in the brain, hemorrhagic insult, or other complications.
• the solution according to the invention allows the balloon, initially within the first
• Lumens of the aspiration catheter is arranged, together with the
• thrombi are fixed to the vessel wall, on the other hand solved by the applied liquid, but can not migrate uncontrollably.
• the balloon is then dilated via the delivery catheter by adjusting the pressure and the amount of fluid, e.g. liquid drug (thrombolytic drug) is increased.
• fluid e.g. liquid drug (thrombolytic drug)
• the balloon Upon reaching a certain pressure, the balloon has reached a size where the outside of its wall abuts the wall of the blood vessel and the thrombi are fixed in place.
• the balloon When the outer skin / outside of the wall of the balloon abuts against the wall of the blood vessel, the balloon has an outside diameter (relative to a projection of the balloon normal to the vessel wall) that is larger than the inside diameter of the first lumen of the aspiration catheter.
• the balloon exerts a significant pressure on the vessel wall.
• dissolved thrombi are at least partially fixed by the balloon and can not be removed, on the other hand is due to the close contact and variable contact pressure of 2 to 10 bar, in particular at least 4 bar, in particular at least 6 bar between the outer wall of the balloon and vessel wall achieved extremely effective application of the drug.
• the openings and / or the (semi) permeable wall area are in particular designed in such a way that an atraumatic application of the fluid occurs at a predetermined fluid pressure.
• the contact pressure to be achieved is achieved by a high internal pressure of the liquid within the balloon of 2 to 10 bar, in particular of at least 4 bar, in particular of at least 6 bar.
• the openings In order to achieve sufficiently high pressures despite the openings in the balloon, the openings must be relatively small, in particular between 10 ⁇ and 100 ⁇ , preferably between 10 ⁇ and 60 ⁇ , more preferably between 20 ⁇ and 50 ⁇ .
• an effective application of the drug is achieved by a high number of small openings, so that a kind of liquid film or a slow wetting of the outside of the balloon occurs while an internal pressure between 2 to 10 bar is maintained.
• the balloon has an areal density of openings (i.e., openings per unit area) of said size of at least
• openings per cm 2 in particular at least 50 openings per cm 2, in particular at least 100 openings per cm 2, in particular at least 500 openings per cm 2, in particular at least 1000 openings per cm, in each case averaged over the entire outer surface of the balloon ( in the dilated state).
• openings are provided both in the proximal end near portion and in the distal end adjacent portion.
• substances which in a high concentration also dissolve old and / or large thrombi.
• these drugs could cause bleeding and other complications.
• the balloon may have at least 50 openings, in particular at least 100 openings, in particular at least 500 openings, in particular at least 1000 openings.
• the size of the balloon in terms of length, diameter, volume or surface - each in a dilated state - may vary.
• the length 1 may be between 10 mm and 20 mm for balloons for the coronary region, between 10 mm and 300 mm for balloons for the peripheral region.
• the diameter may be between 1 mm and 4 mm for balloons for the coronary area, and between 1 mm and 8 mm for the peripheral area.
• the diameter of the balloon may be about 1 mm.
• the infusion element is arranged in particular axially displaceable in the first lumen of the aspiration catheter.
• the infusion element itself can have a guide element, for example a guide wire, in order to be able to displace the infusion element within and out of the first lumen.
• the balloon is designed as a microballoon, which can be taken up in the first lumen of the aspiration catheter in the non-dilated state and passed through the first lumen.
• the balloon is only starting from a certain internal pressure, e.g. 2 bar, permeable to the drug. With the help of a pressure spray, higher internal pressures of up to 10 bar can be achieved. That Only after a certain pressure / volume drug is administered, in particular only when the outer skin already rests against the wall of the blood vessel.
• a certain internal pressure e.g. 2 bar
• the aspiration catheter has a proximal end and a distal end and a longitudinal axis, and the distal end is preferably bevelled.
• the system may include a guide member fixed to the aspiration catheter.
• the aspiration catheter preferably has a second lumen in which the guide element (e.g., guidewire) is at least partially embedded.
• the guide element e.g., guidewire
• the object is achieved by a balloon for a system as described, wherein the balloon has a plurality of openings having a diameter between 10 ⁇ and 100 ⁇ , in particular between 10 ⁇ and 60 ⁇ , in particular between 20 ⁇ and 50 ⁇ .
• the balloon may have a plurality of apertures having an average areal density (i.e., apertures per unit area) of at least 25 apertures per cm 2, more preferably at least 50 apertures per cm 2, more preferably at least 100
• Openings per cm 2 in particular at least 500 O "openings per cm 2, in particular at least 1000 openings per cm, have.
• the balloon may have at least 50 openings, in particular at least 100 openings, in particular at least 1500 openings, in particular at least 1000 openings.
• the balloon may also be constructed as a semipermeable balloon.
• the arrangement of the openings can also be determined by their average distance.
• the average distance is in the invention between the distance between adjacent openings 43 is on average less than 2 mm, preferably less than 1.4 mm, in particular less than 0.7 mm, more preferably less than 0.45 mm, in particular less than 0.3 mm.
• These values result from the density of the apertures over a unit area, as described above.
• arrangements of openings should also be protected in which the surface density, as stated above, is realized only over a certain area of the surface of the balloon. However, in these surface areas, the surface density of the openings (local) should be as indicated above. This means that the mean distance between adjacent openings, if the openings have a nearest neighbor, in these areas in the above areas.
• the design of the balloon and its openings effective application of the effective solution is achieved.
• the drug acts directly on the site to be treated. After delivery to the thrombus, the drug spreads throughout the bloodstream and has a systemic effect.
• the balloon is made of nylon, polyethylene terephthalate (PET), polyamide, polyethylene, and / or polyether block amides (PEBA). It may have openings as described above or at least partially made of (semi-) permeable material, which diffuses the liquid at a corresponding internal pressure or penetrate the membrane.
• PET polyethylene terephthalate
• PEBA polyether block amides
• the apertures are preferably made by laser treatment (e.g., laser cutting, punctiform apertures). In individual cases, however, it is also possible to use e.g. a mechanical formation of the openings take place.
• the internal pressure and thus the volume of the balloon are lowered to such an extent that it can be withdrawn through the first lumen of the aspiration catheter.
• a negative pressure is applied, which causes a collapse or folding of the balloon.
• the balloon is withdrawn through the first lumen, it substantially closes with the first lumen of the suction catheter.
• the result is a negative pressure (negative pressure) or a suction effect (Windkessel effect), the further already dissolved thrombotic material already in this early phase draws into the aspiration catheter and thus removed from the blood vessel.
• a device for generating a negative pressure or suction is connected at the proximal end of the aspiration catheter, e.g. a suction syringe (e.g., Luer Lock syringe) to remove as much of the remainder of the dissolved thrombotic material as possible.
• a suction syringe e.g., Luer Lock syringe
• the permeability is reversible or follows a hysteresis.
• the openings close below the first certain pressure again, so that the volume can be further reduced to a desired value.
• the transmittance disappears upon reaching a second predetermined pressure, which does not have to correspond to the first predetermined pressure.
• the permeability of the balloon does not change or only quantitatively when reducing the pressure.
• the method comprises the following steps: a) providing a system as described above; b) introducing the system into a blood vessel and bringing the distal end of the aspiration catheter to the site to be treated (with the infusion element disposed within the first lumen of the aspiration catheter); c) moving the balloon out of the first lumen of the aspiration catheter to the height of the site to be treated; d) Dilatation of the balloon by introducing a liquid and / or increasing the fluid pressure in the interior of the balloon, wherein from a certain internal pressure, the fluid passes through the balloon-formed openings out through the balloon wall (ie atraumatic application of the liquid at the site to be treated ); e) deflation and retraction of the balloon through the first lumen; and f) aspiration, ie, aspiration of thrombotic material from the blood vessel through the first lumen of the aspiration catheter.
• the balloon is preferably widened so that it bears against the inner wall of the blood vessel or presses against it with a predetermined pressure.
• Another system for removing thrombotic material from a blood vessel comprises an aspiration catheter having a first lumen for aspirating thrombotic material from a blood vessel and a guide member for introducing the aspiration catheter into the blood vessel, wherein the guide member (formed as aspiration catheter and / or or microcatheter) has a proximal end and a distal end and a third lumen through which fluids are transportable from the proximal end of the guide member to the distal end of the guide member.
• the guide member formed as aspiration catheter and / or microcatheter
• the guide element preferably has at least one infusion opening, which is formed in the region of the distal end of the guide element.
• the aspiration catheter has a longitudinal axis and the distal end may be chamfered.
• the guide element is fixed in particular on the aspiration catheter.
• the distal end of the guide member may protrude beyond the edge of the opening of the second lumen of the aspiration catheter.
• the cross section of the first lumen is in particular larger than the cross section of the second lumen.
• the guide element can be designed as a microcatheter and thus act as an infusion element.
• FIG. 1 A representation of an embodiment of the fiction, contemporary
• Figure 2 is a representation of the embodiment of Figure 1 in a second
• Figure 3 is a representation of the embodiment of Figure 1 in a third phase of the inventive method
• Figure 4 is a representation of the embodiment of Figure 1 in a fourth phase of the inventive method
• Figure 5 is a representation of the embodiment of Figure 1 in a fifth
• Figure 6 is an illustration of an embodiment of the Invention according to
• FIG. 7 A representation of a detail of the infusion balloon according to the invention from FIG. 6;
• FIG. 8 shows a second embodiment of the infusion
• FIG. 9 A cross section AA of the aspiration catheter according to FIG. 8.
• FIG. 1 shows a system 1 according to the present invention during a surgical procedure in a blood vessel B.
• the blood vessel B may in particular be a coronary vessel on whose wall a thrombus B (plaque) has deposited and forms a constriction to be treated.
• a thrombus B plaque
• the system 1 includes an aspiration catheter 2 having a first lumen 20, a distal end 21 (with a distal opening 210) and a proximal end with a proximal opening (not shown).
• a central axis 22 extends longitudinally between the proximal end and the distal end 21.
• the system 1 also includes a guidewire 3, which also has a proximal end (not shown) and a distal end 30.
• the guide wire 3 is arranged in a second lumen of the aspiration catheter 2.
• the guide wire 3 is immovably connected to the aspiration catheter 2 so that the guide wire 3 is not longitudinally displaceable with respect to the aspiration catheter 2. It protrudes beyond the distal opening of the second lumen.
• the surface defined by the edge of the opening 210 of the aspiration catheter 2 is inclined with respect to the axis 22 at an angle of approximately 45 °.
• an infusion element within the aspiration catheter 2 is an infusion element, with infusion balloon 4 collapsed at this time, having an interior / interior volume 40 delimited by a wall 41 and a delivery catheter 42.
• the balloon 4 is folded to have a low profile has, ie the cross-section is such that the balloon can be placed in the aspiration lumen and moved therethrough.
• Delivery catheter 42 is designed to deliver saline solution (saline) for rinsing or thrombolytic drug into interior space 40.
• saline solution saline
• the balloon 4 has an actuating element, for example a separate one
• the catheter 2 is introduced into the blood vessel by actuation of the guide wire 3 together with the (still folded) balloon 4, which is arranged in the first lumen 20 of the aspiration catheter 2 (namely in the aspiration lumen) until he reaches his destination position.
• the determination position is reached when the opening 210 is located a certain distance in front of the thrombus T.
• the distal end 21 of the catheter 2 in this position reaches the constriction (caused by the thrombus) to be treated.
• the balloon 4 is pushed out of the first lumen 21 until it is approximately at the level of the thrombotic site to be treated. There it is unfolded and / or dilated by introducing a drug via the delivery catheter 42.
• a pressure syringe is preferably used, which can generate correspondingly high and defined internal pressures in the interior 40 of the balloon 4.
• the drug M is, when the internal pressure of the drug has reached a certain limit, applied via a plurality of micro-openings 43 from the interior 40 of the balloon 4 in the blood vessel B. Due to the small diameter of the openings of 10 ⁇ to 100 ⁇ the drug M penetrates only slowly from the balloon interior 40 from.
• the drug wets more or less the outer side of the balloon wall 41. At the same time it is ensured by the formation of the openings 43 with the diameters mentioned that in the interior 40 a relatively high pressure of 2 bar to 10 bar is maintained. As a result, the balloon wall 41 presses against the region of the wall of the blood vessel B at which thrombotic material is deposited at high pressure.
• FIG. 3 shows the next phase of using the system 1, in which the volume of the internal space 40 is reduced by reducing the pressure of the medicament M in the interior 40 of the balloon 4.
• the balloon body 40 collapses and returns to approximately its original dimensions.
• the openings 43 may, but need not reversibly close (or along a hysteresis loop), so that from a certain internal pressure no drug is applied.
• the administered medicament M unfolds its effect, which is indicated by the dissolution or comminution of thrombotic material D.
• thrombotic material D h which bears against the outside of the wall 41, can adhere to this. Further thrombotic material D may be present dissolved in the blood vessel B.
• the balloon 4 is pulled through the opening 210 and the first lumen 21 to the proximal end of the aspiration catheter 4.
• the balloon is folded so that it has a low profile, i. the cross-section is such that the balloon fits into the aspiration lumen and can be withdrawn therethrough.
• the balloons 4 can produce a suction effect, indicated by the arrows of the debris particles D following the suction (wind boiler effect), and remove thrombotic material D from the blood vessel B through the first lumen 20.
• the thrombotic material D is sucked off via the first lumen 20.
• a suction device is attached to the proximal end of the aspiration catheter 4 (not shown). In this way, the remaining in the blood vessel B thrombotic material D is largely removed.
• FIG. 6 schematically shows the structure of a microballoon according to the invention.
• Infusion balloon 4 in a dilated state is the
• the balloon volume 40 has a Length 1 from 10 mm to 20 mm.
• the plurality of openings 43 are formed both in the proximal and in the distal part region of the balloon body 4. The introduced into the balloon 4 liquid should in particular also act in the distal region of the balloon.
• the internal volume 40 of the balloon 4 increases until, during treatment, the outside of the wall or skin 41 of the balloon 4 abuts the wall of the blood vessel and encloses thrombotic material there or pressed against the wall.
• the balloon has the following geometry: In the inflated state, the balloon is substantially cylindrical or tubular with a central axis Z and a radius of h / 2. At each end, the balloon 4 has an annular shoulder 44a and 44b, respectively. The annular shoulder has a radius which corresponds approximately to that of the outer shell of the cylindrical body. At the level of the shoulder 44a and 44b, respectively, a radiopaque marker 45a and 45b is arranged to allow localization of the balloon 4, in particular to ensure that the balloon is located in the area of the thrombus prior to inflation.
• the balloon body 40 has, distributed over the entire length 1 or at least over an effective range l e , which is at least 75% of the length 1, openings 43.
• a diameter d which lies between 10 ⁇ m and 100 ⁇ m.
• the diameter d increases so that the supplied medicament or the solution can slowly escape atraumatically above a certain limiting pressure.
• the number of openings is on average - based on the entire surface of the dilated balloon body 40 at least 25 openings per cm, preferably over
• the arrangement of the openings can also be determined by their average distance aj, a j , ....
• the average distance is in the invention between the distance ai, aj, .. between the openings 43 is on average less than 2 mm, preferably less than 1.4 mm, in particular less than 0.7 mm, more preferably less than 0, 45 mm.
• the total number of apertures formed in the balloon body 40 is over 50 apertures and may even be 100 apertures or more. These can be distributed more or less homogeneously over the wall 41.
• the internal pressure can be significantly increased without too much drug is applied in a short time and precludes the construction of a high internal pressure.
• the balloon can cause a greater expansion of the vessels and a greater pressure against the vessel wall by the increased internal pressure.
• a material for the preparation of the wall or skin 41 of the balloon body 40 / the balloon 4 is for example nylon.
• the diameter h is so small that the balloon can be arranged in the first lumen 21 of the delivery catheter 2 and moved through the first lumen 20 of the aspiration catheter 2.
• the size of the aspiration catheter or the cross-sectional area of the first lumen 20 must therefore be adapted to the cross-sectional area of the non-dilated balloon 4, i. in particular, the balloon body cross section must be smaller or lie in the size range of the cross section of the first lumen 21.
• the drug should be applied as atraumatic as possible.
• a pressure syringe is usually used instead of a normal (manual) syringe.
• the pressure spray not only larger pressures, but also defined pressures can be generated.
• the balloon dilates much more and it is greater pressure, for example, up to 10 bar, exerted on the arterial wall.
• the liquid is applied very targeted and plaques and Tromben be better resolved on the vessel wall.
• the balloon pressing against the wall holds loose plaque parts so that they can not be transported to other areas of the body.
• This type of application achieves multiple receptor binding compared to intravenous administration.
• the application can also be targeted locally.
• the application takes place, for example, for one minute.
• the arterial volume in the heart area is 1-2 ml. It is rinsed with 10 ml of saline solution or medication.
• FIG. 1 An alternative embodiment of the inventive system 1 is shown in FIG. 1
• the system 1 does not have a balloon 4 in this case. Instead, a liquid is applied via the guide element 3 of the aspiration catheter 2.
• the aspiration catheter 2 has a first lumen 20 (suction lumen), and a second lumen 23 for guiding the guide element 3.
• the guide member 3 extends between the proximal end (not shown) and the distal end portion 30, which projects beyond the opening 230 of the second lumen 23, a third lumen through which the drug M is administered in the second phase of the application.
• the distal end region 30 of the guide element for example, openings 33 through which the liquid can get into the blood vessel B.
• the guide element 3 is in this case designed as a microcatheter or infusion catheter with the third lumen for supplying the medicament to the openings 33 arranged in the distal region 30.
• FIG. 9 shows a section A-A from FIG. 8 for clarity.
• the first lumen 20 is used in this embodiment only for sucking the dissolved thrombotic material D (suction lumens 20).
• the second lumen 23 serves to receive the guide element 3 in a stationary manner.
• the latter has a third lumen for administering a liquid M.

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• 2015
  • 2015-03-17 DE DE202015002060.7U patent/DE202015002060U1/de not_active Expired - Lifetime
• 2016
  • 2016-03-15 JP JP2017567538A patent/JP2018508334A/ja active Pending
  • 2016-03-15 CN CN201680015120.6A patent/CN107548297A/zh active Pending
  • 2016-03-15 EP EP16712290.2A patent/EP3271001A1/de not_active Withdrawn
  • 2016-03-15 US US15/559,356 patent/US20180110533A1/en not_active Abandoned
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