WO2022129960A1 - Catheter - Google Patents

Catheter Download PDF

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Publication number
WO2022129960A1
WO2022129960A1 PCT/GR2021/000033 GR2021000033W WO2022129960A1 WO 2022129960 A1 WO2022129960 A1 WO 2022129960A1 GR 2021000033 W GR2021000033 W GR 2021000033W WO 2022129960 A1 WO2022129960 A1 WO 2022129960A1
Authority
WO
WIPO (PCT)
Prior art keywords
surgical tool
catheter
moving element
catheter shaft
moving
Prior art date
Application number
PCT/GR2021/000033
Other languages
French (fr)
Inventor
Giannis STEFANIDIS
Original Assignee
Stefanidis Giannis
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 Stefanidis Giannis filed Critical Stefanidis Giannis
Publication of WO2022129960A1 publication Critical patent/WO2022129960A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/3205Excision instruments
    • A61B17/3207Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0015Gastrostomy feeding-tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • A61J15/003Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters
    • A61J15/0038Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type
    • A61J15/0042Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters expandable, e.g. umbrella type inflatable
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • A61J15/0053Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin
    • A61J15/0061Means for fixing the tube outside of the body, e.g. by a special shape, by fixing it to the skin fixing at an intermediate position on the tube, i.e. tube protruding the fixing means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • A61J15/0073Multi-lumen tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00535Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated
    • A61B2017/00539Surgical instruments, devices or methods, e.g. tourniquets pneumatically or hydraulically operated hydraulically
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22038Implements 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 a guide wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22051Implements 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
    • A61B2017/22054Implements 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 with two balloons
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22051Implements 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
    • A61B2017/22065Functions of balloons
    • A61B2017/22069Immobilising; Stabilising
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22Implements 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
    • A61B2017/22082Implements 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
    • A61B2017/22084Implements 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0067Catheters; Hollow probes characterised by the distal end, e.g. tips
    • A61M25/0082Catheter tip comprising a tool
    • A61M2025/0096Catheter tip comprising a tool being laterally outward extensions or tools, e.g. hooks or fibres
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1011Multiple balloon catheters
    • A61M2025/1015Multiple balloon catheters having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system

Definitions

  • the present invention refers to a catheter.
  • the catheter of the present invention can also be characterized as a medical catheter.
  • Catheters have been used for years in many medical applications for humans and animals, as they provide access to the body in a minimally invasive way.
  • catheters are widely used in most endovascular applications. Due to their minimal invasive character, the treatment of blood vessel pathologies can be achieved without considerable postoperative pain and the need of a general anaesthesia during the operation or a long hospitalization of the patient.
  • An endovascular catheter is known from WO 2016 203277 A1.
  • the catheter comprises a catheter shaft, a first surgical tool, a second surgical tool and a first moving means.
  • the catheter shaft extends along a longitudinal axis.
  • the first surgical tool and the second surgical tool are movable relative to each other in the direction of the longitudinal axis.
  • the first surgical tool is movable on the catheter shaft in the direction of the longitudinal axis by the first moving means.
  • the second surgical tool may be movable on the catheter shaft in the direction of the longitudinal axis by a second moving means or fixed on the catheter shaft.
  • the first surgical tool and the second surgical tool are arranged on the catheter shaft and are movable relative to each other in the direction of the longitudinal axis.
  • the first surgical tool is movably arranged on the catheter shaft.
  • the first moving means is configured to move the first surgical tool on the catheter shaft in the direction of its longitudinal axis.
  • the second surgical tool may be either movably arranged or fixed on the catheter shaft.
  • a second moving means is configured to move the second surgical tool on the catheter shaft in the direction of its longitudinal axis.
  • the catheter of the present invention having two surgical tools, which are controllably movable relative to each other, has the advantage that a distance between the two surgical tools can controllably be adjusted. Further, the position of the first surgical tool relative to the catheter shaft can also be adjusted. Especially when both surgical tools, namely the first and the second surgical tool, are movable, a more precise adjustment of the distance between the two surgical tools as well as of the position of each of the surgical tools relative to the catheter shaft can be achieved. Depending on the initial relative distance between the two surgical tools when they are both located at their proximal position and on the ranges of their movement in the longitudinal direction of the catheter shaft, the catheter can be used in various medical applications as well as in patients with different anatomical characteristics and/or a different clinical condition.
  • the catheter of the present invention can advantageously be used as an endovascular, a gastrointestinal or a urological catheter.
  • the first surgical tool is a proximal surgical tool and the second surgical tool a distal surgical tool.
  • the first surgical tool is preferably closer to a proximal shaft end than the second surgical tool is to the proximal shaft end.
  • the second surgical tool is preferably closer to a distal shaft end than the first surgical tool is to the distal shaft end.
  • the catheter of the present invention may comprise more than two surgical tools, namely further surgical tools apart from the first surgical tool and the second surgical tool . Also in this case, like in the case of the catheter having the first surgical tool and the second surgical tool, it is sufficient for achieving the aforementioned advantages for the catheter of the present invention if at least one of the surgical tools is longitudinally movably arranged on the catheter shaft.
  • the catheter further comprises a third surgical tool that is fixed on the catheter shaft.
  • the first surgical tool and the second surgical tool are movably arranged on the catheter shaft and the third surgical tool is fixed on the catheter shaft.
  • the third surgical tool is arranged between the first surgical tool and the second surgical tool.
  • Any of the surgical tools of the catheter in particular the first surgical tool and/or the second surgical tool and/or the third surgical tool, can each be formed as an inflatable balloon, a cutting device, a stent, a stabilizing tool, a pressure sensor or any other tool that can be used in a surgical procedure, in which a catheter is used.
  • the cutting device can in particular be a blade, for example an atherectomy blade, or a Fallopian tube scraping wire (curretage wire for uterine curettage).
  • any combination of the aforementioned tools is possible. However, it is most preferable that at least one of the surgical tools is an inflatable balloon.
  • the first surgical tool being movably arranged on the catheter shaft is an inflatable balloon.
  • the catheter with the first surgical tool being an inflatable balloon has in addition to the advantage of the adjustment of the position of the balloon relative to the second surgical tool and to the catheter shaft the advantage of improving the characteristics of the catheter. This will be described in more detail in the following.
  • the balloon When the inflatable balloon is inflated inside a body lumen, the balloon is anchored to the wall defining the lumen and thus cannot be moved with respect to said wall. Therefore, applying a force to the first moving means is translated to a movement of the catheter shaft relative to the balloon.
  • the catheter may acquire greater pushability, since the needed propulsive force for moving the catheter shaft forward can be applied close to its tip.
  • pushability means the degree in which the force transmitted from a proximal shaft end part of the catheter shaft is translated into movement of a distal shaft end part (tip) of the catheter shaft, which depends on the transmission of the force along the body of the catheter shaft.
  • the term “pushability” means the ease of advancing the catheter inside a lumen, e.g. a blood vessel, and is indicative of the amount of force the distal shaft end part of the catheter shaft sees when a known force is being applied to the proximal end part of the catheter shaft.
  • crossability i.e. the ability to navigate the tip of the catheter shaft across narrow restrictions in the vasculature
  • the suggested catheter can be moved through a significant stenosis with greater force by using the propulsive force applied by the moving balloon when pushing the tip of the catheter shaft.
  • the catheter can offer maximal backup support to the guidewire and in addition, the greatest possible pushability, crossability and trackability over the guidewire in narrowed or blocked lumens and passages of the patient’s body.
  • the catheter shaft can provide backup support to the guidewire in the effort to move it through anatomically difficult areas of lumens of the human body, while - at the same time - it can be accurately repositioned, keeping the balloon inflated and anchored within the lumen.
  • the trackability of the catheter shaft over the guidewire is high, since once again the propulsive force of the balloon moving close to the tip of the catheter shaft is much greater. This is specifically advantageous in tortuous lumens, where the crossing of the catheter is hindered due to the multiplication of the friction between the catheter shaft and the lumen walls as well as between the catheter shaft and the guidewire caused by the existing tortuosity.
  • the second surgical tool is for example a cutting device such as an atherectomy blade fixed on the catheter shaft
  • the improvement of the catheter’s characteristics as described above results in in the cutting device being able to cut with more force.
  • the reason for this is that applying a pushing force to the balloon by the first moving means when the balloon is inflated and thus anchored to the walls of a body lumen is translated into a forward movement of the catheter shaft with a high force and thus to a forward movement with a high force also of the cutting device.
  • the first surgical tool is formed as a first inflatable balloon and the second surgical tool as a second inflatable balloon fixed or movably arranged on the catheter shaft
  • the improvement of the catheter’s characteristics as described above results in the ability of the catheter shaft to be forwarded through narrowed passages of the patient’s body in order to place the second inflatable balloon at the position of the stenosis.
  • the second inflatable balloon can advantageously be positioned inside the stenosis and then inflated in order to widen the narrowed passage.
  • the first surgical tool, the second surgical tool and the third surgical tool of the catheter are inflatable balloons.
  • the third surgical tool being fixed on the catheter shaft is arranged between the first surgical tool and the second surgical tool.
  • the catheter shaft preferably comprises an inflating fluid passing lumen that communicates with the inflatable balloon through an inflating fluid passing opening formed in a circumferential area of the catheter shaft.
  • the third surgical tool can be provided with inflating fluid through the inflating fluid passing lumen.
  • the catheter comprises a plurality of inflatable balloons fixed on the catheter shaft, the same inflating fluid passing lumen can be used for delivering inflating fluid to some or all of the inflatable balloons.
  • a plurality of inflating fluid passing openings is formed in the circumferential area of the catheter shaft, wherein the corresponding inflating fluid passing openings are in communication with the inflating fluid passing lumen.
  • the catheter may comprise one (separate) inflating fluid passing lumen per inflatable balloon.
  • the first surgical tool is formed as an inflatable balloon and the second surgical tool is fixed to the catheter shaft and formed as a cutting device.
  • the first surgical tool is formed as a stabilizing tool and the second surgical tool is a movable surgical tool and formed as an inflatable balloon.
  • the first moving means comprises a first moving element.
  • the first moving element is flexible, connected to the first surgical tool and arranged in a first moving means receiving lumen defined by a catheter shaft wall.
  • the first moving element is arranged in the first moving means receiving lumen in such a way that the first moving element is at least partially circumferentially supported by the catheter shaft wall so that the first surgical tool is movable by the first moving element in a direction from a proximal shaft end to a distal shaft end of the catheter shaft.
  • the first moving element is preferably hollow and in fluid communication with the first inflatable balloon.
  • the second moving means preferably comprises a second moving element.
  • the second moving element is flexible, connected to the second surgical tool and arranged in a second moving means receiving lumen defined by a catheter shaft wall.
  • the second moving element is arranged in the second moving means receiving lumen in such a way that the second moving element is at least partially circumferentially supported by the catheter shaft wall so that the second surgical tool is movable by the second moving element in a direction from a proximal shaft end to a distal shaft end of the catheter shaft.
  • the first/second moving element is/are movable in such a way that its movement causes a movement of the first/second surgical tool.
  • the first/second moving element is/are arranged in a way that it/they is/are laterally supported by the catheter shaft wall so that the first/second moving element, even though being itseif/themselves bendable, can push the first/second surgical tool.
  • the first/second moving element would, at least partially, bend when being moved in the direction from the proximal shaft end to the distal shaft end of the catheter shaft, i.e.
  • the first/second moving element is/are advantageously confined by the catheter shaft wall so that the first/second moving element functions as a stiffer element when being pushed, so that the first/second moving element can transmit its movement to the first/second surgical tool.
  • the catheter shaft wall acts as a restriction and support element for the first/second moving element so that the first/second moving element is/are supported throughout its/their movement in the first/second moving means receiving lumen such that this movement results in a corresponding movement of the first/second surgical tool.
  • the catheter shaft wall provides to the first/second moving element the stiffness that the first/second moving element inherently lacks/lack and hence needs/need in order to be able to move the first/second surgical tool.
  • the first/second moving element is/are capable of being bent, when the catheter, in particular the catheter shaft, is forwarded through curved paths, e.g. tortuous blood vessels, of the body of a patient.
  • the above-described arrangement of the first/second moving element for moving the first/second surgical tool has the advantage that the catheter may have a compact structure, as it is sufficient that the catheter shaft comprises only one moving means receiving lumen per movable surgical tool. More specifically, the present invention allows for a reduction of a maximum outer dimension, in particular a maximum outer diameter, of the catheter/catheter shaft compared to a catheter with a catheter shaft requiring two moving means receiving lumens per movable surgical tool. This in turn has the advantage that the catheter can be used in a large variety of applications and more particularly in applications where blood vessels, lumens and cavities of small dimensions of a human or animal body should be accessed.
  • a catheter with the same maximum outer dimension, in particular the same maximum outer diameter can be provided with more surgical tools than a catheter that requires two moving means receiving lumens per movable surgical tool.
  • the catheter provides a great flexibility in view of the spatial arrangement of the moving means receiving lumen(s) with respect to any further lumen(s) that might be formed in the catheter shaft, such as a lumen for transferring fluids therethrough and/or receiving a guidewire.
  • the catheter can be still bent as a whole.
  • the first/second moving element does/do not alter the flexible nature of the catheter as a whole.
  • a catheter is in particular understood as a device having a flexible (catheter) shaft for insertion into a body cavity, duct, canal, vessel or passageway of a patient and being configured to deliver to or withdraw fluids from a patient through its catheter shaft and/or distend a passageway and/or place a surgical tool at a target site inside the patient’s body in order to cause a modification of the body cavity, duct, canal, vessel or passageway.
  • the first/second surgical tool is/are connected to the first/second moving element at a distal portion and/or distal end of the first/second moving element.
  • the flexibility of the first/second moving element is such that a flexibility of the catheter shaft and/or the catheter with the first/second moving element is not more than 20%, preferably not more than 10%, most preferably not more than 5%, different, in particular larger, than a flexibility of the catheter shaft and/or the catheter without the first/second moving element.
  • the second moving element is preferably hollow and in fluid communication with the second inflatable balloon.
  • the first surgical tool may preferably be controllable by a first control means that is connected to the first moving element.
  • the first control means may advantageously comprise a first control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to the first moving element.
  • the first control casing is the component that a doctor using the catheter manipulates in order to control the first surgical tool.
  • the first moving element may be connected directly to the first control casing.
  • the first control means may comprise a first control element by which the first moving element is connected to the first control casing and which is formed as a stiff control element.
  • the first control means comprises the aforementioned first control element without the first control casing.
  • the first control element is the component that a doctor using the catheter manipulates in order to control the first surgical tool.
  • the first control casing is connected to the first moving element via a first proximal connection opening.
  • the second surgical tool may preferably be controllable by a second control means that is connected to the second moving element.
  • the second control means may advantageously comprise a second control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to the second moving element.
  • the second control casing is the component that a doctor using the catheter manipulates in order to control the second surgical tool.
  • the second moving element may be connected directly to the second control casing.
  • the first control means may comprise a second control element by which the second moving element is connected to the second control casing and which is formed as a stiff control element.
  • the second control means comprises the aforementioned second control element without the second control casing.
  • the second control element is the component that a doctor using the catheter manipulates in order to control the second surgical tool.
  • the first moving means may preferably further comprise a first distal piston and a first proximal piston, which are arranged in the first moving means receiving lumen.
  • a first space between the first distal piston and the first proximal piston is filled with an incompressible fluid.
  • the first moving element is further connected to the first distal piston.
  • the first moving element is arranged in the first moving means receiving lumen in such a way that the first moving element is at least partially circumferentially supported by the catheter shaft wall so that a movement of the first proximal piston in a direction from the proximal shaft end of the catheter shaft to the distal shaft end of the catheter shaft causes a movement of the first surgical tool.
  • the arrangement of the first moving element in the first moving means receiving lumen is such that a movement of the first proximal piston being transferred to the first distal piston via the incompressible fluid can be transferred to the first surgical tool via the first moving element.
  • the second moving means may preferably further comprise a second distal piston and a second proximal piston, which are arranged in the second moving means receiving lumen.
  • a second space between the second distal piston and the second proximal piston is filled with an incompressible fluid.
  • the second moving element is further connected to the second distal piston.
  • the second moving element is arranged in the second moving means receiving lumen in such a way that the second moving element is at least partially circumferentially supported by the catheter shaft wall so that a movement of the second proximal piston in a direction from the proximal shaft end of the catheter shaft to the distal shaft end of the catheter shaft causes a movement of the second surgical tool.
  • the arrangement of the second moving element in the second moving means receiving lumen is such that a movement of the second proximal piston being transferred to the second distal piston via the incompressible fluid can be transferred to the second surgical tool via the second moving element.
  • first/second flexible movement also apply to the embodiment of the catheter using an incompressible fluid between two pistons for transmitting a movement is advantageous as a controlled transmission of the movement between the pistons can be achieved.
  • a length of the first/second space filled with the incompressible fluid and a length of the first/second moving element in the direction of the longitudinal axis of the catheter shaft can be adapted to the application for which the catheter is intended.
  • the first/second space filled with the incompressible fluid can be chosen such that the first/second moving element has a smaller length, if the catheter is made to be used in lumens with large tortuosity.
  • the length of the first/second flexible element can be chosen to be shorter, if tortuous lumens should be accessed with the catheter. Further, the force being transferred from the first/second proximal piston to the first/second distal piston is independent from the speed of movement of the first/second proximal piston. As an incompressible fluid, water or a water solution can be used for filling the first/second space between the pistons.
  • a movement of the first/second proximal piston in a direction from the distal shaft end of the catheter shaft to the proximal shaft end of the catheter shaft effects a corresponding movement of the first/second surgical tool as the movement of the first/second proximal piston results in a build up of negative pressure in the first/second space between the first/second proximal piston and the first/second distal piston, what in turn causes the fluid and the first/second distal piston to be moved/pulled in the same direction with the first/second proximal piston.
  • the movement of the first/second distal piston is then transferable to the first/second moving element, which in turn pulls the first/second surgical tool connected thereto.
  • proximal piston and distal piston with regard to the first and second proximal pistons and the first and second distal pistons, respectively, mean that the respective proximal piston is closer to the proximal shaft end of the catheter shaft than the respective distal piston is to the proximal shaft end.
  • the respective distal piston is closer to the distal shaft end of the catheter shaft than the respective proximal piston is to the distal shaft end.
  • the first moving element when the first surgical tool is formed as a first inflatable balloon, the first distal piston and the first proximal piston are advantageously also hollow. Moreover, in addition to the first moving element being in fluid communication with the first surgical tool, the first moving element is preferably also in fluid communication with a first conduit that is arranged between the first distal piston and the first proximal piston.
  • the second moving element when the second surgical tool is formed as a second inflatable balloon, the second distal piston and the second proximal piston are advantageously also hollow. Moreover, in addition to the second moving element being in fluid communication with the second surgical tool, the second moving element is preferably also in fluid communication with a second conduit that is arranged between the second distal piston and the first proximal piston.
  • the term “at least partially” in the corresponding expressions “at least partially circumferentially supported” presented above in connection to the first/second moving element refers to the term "circumferentially”.
  • the first/second moving element is/are supported at least over a part of its whole circumference at a given cross-section.
  • the first/second moving element can be supported over its/their whole circumference at a given cross-section.
  • the at least partial circumferential support provided by the catheter shaft wall defining the first/second moving means receiving lumen means in particular that the support is provided by an inner portion, preferably an inner surface, of the catheter shaft wall facing the first/second moving means receiving lumen.
  • the first/second moving element is/are completely circumferentially supported by the catheter shaft wall. This means that the first/second moving element is supported over its/their whole circumference at a given cross-section.
  • the first/second moving element is/are longitudinally movably arranged in the first/second moving means receiving lumen. More particularly, the first/second moving element is/are extractably arranged in the first/second moving means receiving lumen. This means that the first/second moving element can be moved out of the first/second moving means receiving lumen due to the at least partial circumferential support by catheter shaft wall so that the first/second moving element can move the surgical tool.
  • the first/second moving means receiving lumen may preferably be configured such that it/they provides/provide over only a portion of its/their length or over its/their whole length the at least partial circumferential support to the first/second moving element.
  • the first/second moving element is/are advantageously flexible over its/their whole length. Furthermore, a flexibility of the first/second moving element may vary along its length. This allows the first/second moving element to be adapted to a respective application of the catheter.
  • the first surgical tool is preferably controllable by a first control means connected to the first proximal piston.
  • the first control means preferably comprises a first control element.
  • the first control element is formed as a stiff control element connected to or formed integrally with the first proximal piston.
  • the first control element is formed as a flexible control element connected to the first proximal piston and arranged in such a way that the first control element is at least partially circumferentially supported by the catheter shaft wall so that the first proximal piston is movable towards the distal shaft end of the catheter shaft by the first control element.
  • the first control means preferably further comprises a first control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to first control element.
  • the first control element is connected to the first control casing via a first proximal connection opening.
  • the second surgical tool is preferably controllable by a second control means connected to the second proximal piston.
  • the second control means preferably comprises a second control element.
  • the second control element is formed as a stiff control element connected to or formed integrally with the second proximal piston.
  • the second control element is formed as a flexible control element connected to the second proximal piston and arranged in such a way that the second control element is at least partially circumferentially supported by the catheter shaft wall so that the second proximal piston is movable towards the distal shaft end of the catheter shaft by the second control element.
  • the second control means preferably further comprises a second control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to second control element.
  • the second control element is connected to the second control casing via a second proximal connection opening,
  • a maximum cross-sectional area or a maximum outer dimension of the first moving element may be at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a minimum cross- sectional area or of a minimum inner dimension of the first moving means receiving lumen, respectively.
  • a maximum cross-sectional area or a maximum outer dimension of the second moving element may be at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a maximum cross-sectional area or of a minimum inner dimension of the second moving means receiving lumen.
  • At least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between a first end position and a second end position of the first/second flexible moving element has a cross-sectional area over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a cross-sectional area of the first/second moving means receiving lumen.
  • the first/second flexible moving element has over its whole length a cross- sectional area that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a cross- sectional area of the first/second moving means receiving lumen.
  • first/second moving means receiving lumen and at least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and second end positions of the first/second flexible moving element are each formed as a circular cylinder
  • at least said first/second flexible moving element portion has over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, a diameter that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the first/second moving means receiving lumen.
  • the first/second flexible moving element has over its whole length a diameter that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the first/second moving means receiving lumen.
  • a fit between the first/second flexible moving element and the first/second moving means receiving lumen is a clearance fit.
  • a length of a portion or the whole of the first/second flexible moving element means in particular a length of the portion or the whole of the flexible moving element in the direction of its longitudinal axis, respectively.
  • first/second flexible moving element portion means in particular the portion of the first/second flexible moving portion, that is arranged in the lumen during its movement from the first end position to the second end position or vice versa.
  • first/second flexible moving element and the first/second moving means receiving lumen By choosing the dimensional relationship of the first/second flexible moving element and the first/second moving means receiving lumen as presented, it can be ensured that most of the force with which the first/second flexible moving element is pushed can be transferred to the first/second surgical tool and cause it to move, in particular be pushed.
  • the term “substantially” in connection with the terms “cross-sectional area” and/or “diameter” means in particular that the first/second moving means receiving lumen and the first/second flexible moving element are produced within the technical tolerances of the method(s) used to manufacture said elements.
  • At least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and the second end positions of the first/second flexible moving element has over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, the same shape with the first/second moving means receiving lumen.
  • the first/second flexible moving element has over its whole length the same shape with the first/second moving means receiving lumen.
  • the first/second flexible moving element is arranged in the first/second moving means receiving lumen in such a way that the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and the second end positions of the first/second flexible moving element has over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, a shape that is complementary to a shape of the first/second moving means receiving lumen.
  • both the first/second flexible moving element and the first/second moving means receiving lumen have an elliptical cross-section
  • the first/second flexible moving element is arranged in the first/second moving means receiving lumen in such a way that a major axis and a minor axis of the first/second flexible moving element are aligned with a major axis and a minor axis of the first/second moving means receiving lumen, respectively.
  • At least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and the second end positions of the first/second flexible moving element, in particular the whole first/second flexible moving element, is formed as a circular cylinder.
  • the first/second moving means receiving lumen is formed as a circular cylinder.
  • the first surgical tool may preferably be connected directly to the first moving element and directly arranged on the catheter shaft.
  • the first surgical tool can be arranged on, in particular fixed to, a first tool-receiving casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft, and connected to the first moving element.
  • the first tool-receiving casing is arranged between the first flexible moving element and the first surgical tool.
  • the first surgical tool can also be directly connected to the first moving element.
  • the second surgical tool is preferably connected directly to the second moving element and directly arranged on the catheter shaft.
  • the second surgical tool can be arranged on, in particular fixed to, a second tool-receiving casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft, and connected to the second moving element.
  • the first tool-receiving casing is arranged between the second flexible moving element and the second surgical tool.
  • the second surgical tool can also be directly connected to the second moving element.
  • the first surgical tool is connected to the first moving means via a first distal connection opening formed in a circumferential area of the catheter shaft.
  • the second surgical tool When the second surgical tool is movable on the catheter shaft in the direction of the longitudinal axis by the second moving means, the second surgical tool is advantageously connected to the second moving means via a second distal connection opening formed in a circumferential area of the catheter shaft.
  • any movable surgical tool provided in the catheter is connected to its corresponding moving means via a corresponding distal connection opening formed in the circumferential area of the catheter shaft.
  • the number of movable surgical tools is equal to the number of moving means and to the number of the distal connection openings.
  • the catheter shaft further comprises at least one further lumen for receiving a guidewire and/or passing a substance, in particular, fluid therethrough, e.g. for delivering a fluid to a site of interest in the patient’s body and/or removing body or other fluids from the patient’s body.
  • the at least one further lumen comprises at least one guidewire receiving lumen and at least one substance passing lumen as separate lumens.
  • the catheter together with a guidewire can be characterized as a catheter assembly.
  • the at least one further lumen advantageously extends over a whole length of the catheter shaft.
  • a proximal end and a distal end of the at least one further lumen correspond to a proximal shaft end and a distal shaft end of the catheter shaft, respectively.
  • the at least one further lumen may extend a partial length of the catheter shaft.
  • the catheter shaft comprises at least one body fluid bypass opening.
  • the at least one body fluid bypass opening is formed in a circumferential area of the catheter shaft and is in fluid communication with the at least one further lumen.
  • the at least one body fluid bypass opening is arranged proximally to the first surgical tool, the first surgical tool being closer to the proximal shaft end of the catheter shaft than the second surgical tool (is to the proximal shaft end).
  • the first surgical tool and the second surgical tool are compared to each other a proximal surgical tool and a distal surgical tool, respectively.
  • the first surgical tool and the second surgical tool are inflatable balloons.
  • This configuration allows body fluids to distally enter the at least one further lumen and to proximally exit the at least one further lumen through the at least one body fluid bypass opening.
  • body fluids that flow in the body lumen in which the catheter is positioned can bypass the portion of the body lumen between the two inflatable balloons when these are inflated.
  • the exact position of the at least one body fluid bypass on the catheter shaft can be chosen according to the medical application for which the catheter is intended.
  • a part of the body fluids can exit the at least one further lumen at a desired position, while the rest of the body fluids can exit the at least one further lumen through an opening formed at the distal shaft end of the catheter shaft.
  • the catheter shaft may comprise a plurality of body fluid bypass openings.
  • the body fluid bypass openings can preferably be spaced from each other in the direction of the longitudinal axis and/or in a circumferential direction of the catheter shaft.
  • a part of the body fluids can be more evenly distributed proximally to the first surgical tool being formed as a balloon.
  • the body fluids can distally enter the at least one further lumen through an opening formed at the distal shaft end of the catheter shaft and/or at least one opening, in particular a plurality of openings, formed in a circumferential area of the catheter shaft distally to the second surgical tool being formed as a balloon.
  • the catheter shaft comprises at least one fluid delivering opening formed in a circumferential area of the catheter shaft and being in fluid communication with the at least one further lumen.
  • a fluid can be delivered in a targeted manner to a specific part of the patient’s body through the at least one fluid delivering opening.
  • the catheter shaft may comprise a plurality of fluid delivering openings.
  • the fluid delivering openings can preferably be spaced from each other in the direction of the longitudinal axis and/or in a circumferential direction of the catheter shaft.
  • the at least one fluid delivering opening is arranged between the first surgical too! and the second surgical tool, when the first surgical tool and the second surgical tool are inflatable balloons.
  • a fluid can be delivered to a part of the patient’s body between the balloons that can be isolated when the balloons are inflated.
  • the fluid can be provided only to the isolated part without mixing with any body fluids.
  • the fluid can be a medicament or a contrast agent.
  • the first/second moving element is/are preferably formed as a wire.
  • the term “wire” may also comprise a cable or any other flexible rod-shaped element.
  • the first/second moving element can be any element that can be bent, so that the catheter can be bent as a unit, when being forwarded through lumens and cavities of hollow organs of a patient's body.
  • the first/second control element when being flexible is/are preferably formed as a wire.
  • the term “wire” may also comprise a cable or any other flexible rod-shaped element.
  • the first/second control element when being flexible can be any element that can be bent, so that the catheter can be bent as a unit, when being forwarded through lumens and cavities of hollow organs of a patient’s body.
  • the first/second moving element and/or the first/second control element may be made for example from metal, plastic or a composite material.
  • the term “flexible” describing a component of the catheter, in particular the first/second moving element or the first/second control element when being formed as a first/second flexible control element means advantageously that the respective component is bendable by its own weight.
  • the term “flexible” means that the respective component cannot support/carry/bear its own weight without being bent when it is fixed at one of its ends and the other end is free. It is noted, however, that bending does not mean that the respective component collapses due its own weight when it is fixed at one of its ends and the other end is free. In other words, the flexible component may only partially carry its own weight.
  • the term “stiff” describing a component, in particular the first/second control element when formed as a first/second stiff control element advantageously means that the first/second control element is not bendable by its own weight.
  • the term “stiff” means that the first/second control element can support/carry/bear its own weight without being bent when it is fixed at one of its ends and the other end is free.
  • moving means can in particular be replaced by the term “movement transmitting means”.
  • movement transmitting means a means for transmitting a movement of the hand of a doctor or a movement of the control means, if such a control means is present in the catheter, being moved by a doctor using the catheter to the respective surgical tool is understood.
  • a movement transmitting means can also be understood as a force transmitting means for transmitting a force applied thereto, by the doctor using the catheter, to the respective surgical tool.
  • a first component being fixed to a second component means that there is no relative movement between the first component and the second component at their connection.
  • each of the movable components of the catheter comprises a first end position (proximal end position) and a second end position (distal end position). In the first end position, a distal end of a respective component is at its furthest position with respect to the distal shaft end of the catheter shaft, whereas in the second end position the distal end of a respective component is at its closest position with respect to the distal shaft end of the catheter shaft.
  • a respective component is movable between its corresponding first end position and its second end position.
  • the difference between the first end position and the second end position of the first/second surgical tool corresponds to the range of motion of the first/second surgical tool, in other words the maximum distance that the first/second surgical tool may cover during its movement.
  • the first/second moving element is extracted in its second end position and retracted in its first end position.
  • the first/second moving element is/are partially arranged inside the first/second moving means receiving lumen, when the first/second moving element is/are in its/their first end position corresponding to the first end position of the first/second surgical tool.
  • the first/second moving element may be partially arranged inside the first/second moving means receiving lumen.
  • the first/second moving means comprises/comprise the first/second proximal and distal pistons, it is also possible that the first/second moving element is/are arranged completely outside the first/second moving means receiving lumen in its second end position.
  • the first/second moving element is preferably partially arranged inside the first/second moving means receiving lumen between its/their first end position and second end position, i.e. between the first end position and the second end position of the first/second surgical tool.
  • the first/second control element can be, depending on the design of the catheter, partially or completely arranged in the first/second moving means receiving lumen in its/their second end position.
  • the first/second control element is/are arranged in the part of the first/second moving means receiving lumen that is not arranged inside the body of a patient, when the catheter is inserted in the patient’s body.
  • the first/second control element comprising a first/second control casing and the first/second moving element being connected to the first/second control casing by the first/second control element
  • the first/second control element is/are advantageously arranged at least partially, in particular completely, inside the first/second moving means lumen both in the second end position and in the first end position.
  • the formulation using a (slash) between two features of the catheter can be read as “and/or”.
  • the expression “the first/second moving element” can be read as “the first and/or second moving element”, which is equivalent to the expression “the first moving element and/or the second moving element”.
  • the present invention further refers to a method of use of the described catheter in a surgical procedure.
  • the method comprises the step of providing a previously described catheter.
  • a medical balloon that is inflatable comprising:
  • a first channel cross-section of the at least one channel is larger than a second channel cross-section of the at least one channel, in particular wherein the first channel cross-section is arranged at a first channel end, in particular a proximal channel end, and the second channel cross-section is arranged at a second channel end, in particular s distal channel end.
  • a medical balloon arrangement comprising at least two medical balloons according to any of items 11 to I9, in particular wherein the channels of the at least two medical balloons are connected to and in fluid communication with each other by a conduit.
  • a catheter comprising a medical balloon according to items 11 to I9 or a medical balloon arrangement of item 110.
  • the catheter of 111 further comprising a catheter shaft and/or a tool-receiving casing arranged on the catheter shaft and configured to receive the medical balloon, wherein the medical balloon is directly arranged on the catheter shaft or on the tool-receiving tool.
  • the medical balloon of item 11 has the advantage that it can be fixed inside a lumen or a cavity of a patient's body when it is inflated, while still allowing fluids to be exchanged between the area proximally to the lumen or the cavity and the area distally to the lumen or the cavity. This is in particular advantageous, when the medical balloon is intended to be used in an endovascular catheter, as this would allow at least a partial blood flow in the blood vessel.
  • the different designs of the channel of the medical balloon of item I2 or I3 allow the medical balloon to be used in various medical applications according taking into account the anatomical characteristics of the part of a patient’s body, in which the balloon will be placed.
  • a medical balloon according to either item I2 or I3 can be used in a catheter, which is stabilized by anchoring the balloon to the wall of the oesophagus or a blood vessel of a patient.
  • the inflated balloon is inflated inside the oesophagus or the blood vessel, respectively, while allowing e.g. saliva or blood, respectively, to pass through the channel.
  • a medical balloon according to item I3 might be preferred for example in a gastrointestinal catheter that needs to be prevented from being removed from the patient's body by inflating the balloon inside the stomach of a patient.
  • Another criterion for choosing between the medical balloon according to item I2 or I3 might be the flow characteristics of a fluid inside the part of the patient's body, in which the balloon will be placed.
  • the channel of a medical balloon according to item I2 will be closer to the wall of a body lumen of the patient than the channel of a corresponding medical balloon according to item I3, when the balloon is placed inside a body lumen.
  • the velocity of the fluid close to the wall is generally expected to be smaller than that in the middle of the body lumen.
  • a catheter according to item of I2 might be used when there is an adequate fluid flow in the body lumen
  • a medical balloon according to item I3 might be used when a weaker fluid flow occurs in the body lumen.
  • a first portion of the circumferential area of the medical balloon at a given cross-section has a larger dimension than a second portion of the circumferential area at the same cross-section.
  • the medical balloon may be particularly regarded as having a main region and two or more protruding regions protruding from the main region.
  • the protruding regions are the regions of the medical balloon intended to contact the wall of a body lumen or cavity of a patient, when the balloon is in its inflated state inside the body lumen or cavity.
  • the number of the protruding regions corresponds to the number of the recesses.
  • the medical balloon of item 14 is advantageous particularly in cases, in which a body fluid in a first body region being separated from a second body region by the balloon when inflated is desired or required to pass from the first body region to the second body region, while a body fluid present in the second body region should not be allowed to pass tot he first body region.
  • the first body region might comprise the oesophagus and the second body region the stomach of a patient. Saliva should be allowed to pass from the oesophagus to the stomach, when the medical balloon is anchored to the oesophagus wall, while the gastric contents should not be able to enter the oesophagus.
  • the selective fluid flow in only one or substantially in one direction can be achieved by the medical balloon of items 15 to 17.
  • the medical balloon of item 15 or 16 may have the advantage that a fluid passing through the channel might exit through a smaller or larger crosssection that that through which the fluid entered.
  • Providing two or more channels in the medical balloon of item 18 has the advantage that a larger fluid volume can be passed through the channels.
  • the arranging region for arranging the medical balloon on a component of a catheter in the medical balloon of item 19 may extend in the direction of the longitudinal axis of a component of a catheter shaft, in particular a catheter shaft or a tool-receiving casing arranged on the catheter shaft and configured to receive the balloon.
  • using the medical balloon arrangement of item 110 has the advantage that passing of fluid from a first region of the body proximally to the first medical balloon to a second region of the body distally to the second medical balloon or from said second region to said first region is made possible.
  • the medical balloon of items 11 to I9 can be used as the first surgical tool and/or the second surgical and/or the third surgical tool in a catheter according to the present invention, when any of these surgical tools is formed as an inflatable balloon . It is also possible that the medical balloon of items 11 to I9 is an independently tradable product.
  • figures 1 to 3 simplified schematic perspective views of a catheter with three surgical tools according to a first embodiment of the present invention
  • figure 4 a simplified schematic perspective view of a part of the catheter of the first embodiment
  • figure 5 a simplified schematic perspective view of a part of the catheter of the first embodiment
  • figure 6 a simplified schematic perspective view of a part of a catheter according to a second embodiment of the present invention
  • figures 7 to 9 simplified schematic views of an application of the catheter of the first or second embodiment
  • figure 10 a simplified schematic perspective view of a catheter according to a third embodiment of the present invention together with an application of said catheter
  • figure 11 a simplified schematic perspective view of a catheter with two surgical tools according to a fourth embodiment of the present invention
  • figure 12 a simplified schematic perspective view of a part of the catheter of the fourth embodiment
  • figure 13 a simplified schematic perspective view of a catheter with two surgical tools according to a fifth embodiment of the present invention
  • figure 14 a simplified schematic perspective view of a part of the catheter of the fifth embodiment
  • figure 15 a simplified schematic
  • Figures 1 to 5 show a catheter 100 according to a first embodiment of the present invention.
  • the catheter 100 comprises a catheter shaft 2, a first surgical tool 11 , a second surgical tool 12 and a third surgical tool 13.
  • the catheter shaft 2 extends along a longitudinal axis 500 from a proximal shaft end 29 to a distal shaft end 28. Further, the catheter shaft 2 comprises a main body 201 and a tip 202 attached to the main body 201.
  • the first surgical tool 11 and the second surgical tool 12 are movably arranged on the catheter shaft 2, while the third surgical tool 13 is fixed on the catheter shaft 2 and arranged between the first surgical tool 11 and the second surgical tool 12 in the direction of the longitudinal axis 500.
  • the first surgical tool 11 and the second surgical tool 12 are movable on the catheter shaft 2 in the direction of the longitudinal axis 500.
  • the first surgical tool 11 , the second surgical tool 12 and the third surgical tool 13 are movable relative to each other in the direction of the longitudinal axis 500.
  • the first surgical tool 11 is in particular a proximal surgical tool and the second surgical tool 12 a distal surgical tool.
  • the catheter 100 comprises a first moving means 31 and a second moving means 32, respectively.
  • the first moving means 31 is formed as a first moving element 310 and the second moving means 32 as a second moving element 320.
  • Both the first moving element 310 and the second moving element 320 are flexible and preferably formed as wires.
  • the first moving element 310 is connected to the first surgical tool 11 and arranged in a first moving means receiving lumen 21 defined by a catheter shaft wall 20. Accordingly, the second moving element 320 is connected to the second surgical tool 12 and arranged in a second moving means receiving lumen 22 defined by the catheter shaft wall 20.
  • the first and second moving means receiving lumens 21 , 22 are better shown in figures 2 and 4.
  • the first surgical tool 11 is fixed to/loaded on a first tool-receiving casing 61 , which is connected to the first moving element 310.
  • the first moving element 310 is connected to the first surgical tool 11 by the first tool-receiving casing 61.
  • the first tool-receiving casing 61 is longitudinally movably, in particular slidably, arranged on the catheter shaft 2.
  • the tool-receiving casing 61 and the first surgical tool 11 can be moved as a unit by the first moving element 310 in the direction of the longitudinal axis 500 of the catheter shaft 2.
  • the second surgical tool 12 is fixed to/loaded on a second tool-receiving casing 62, which is connected to the second moving element 320.
  • the second moving element 320 is connected to the second surgical tool 12 by the second tool-receiving casing 62.
  • the second tool-receiving casing 62 is longitudinally movably, in particular slidably, arranged on the catheter shaft 2 and connected to the second moving element 320.
  • the tool-receiving casing 62 and the second surgical tool 12 can be moved as a unit by the second moving element 320 in the direction of the longitudinal axis 500 of the catheter shaft 2.
  • first surgical tool 11 and/or the second surgical tool 12 are formed such that the first surgical tool 11 and/or the second surgical tool 12 is/are directly movably arranged on the catheter shaft 2.
  • first surgical tool 11 is directly connected to the first moving element 310 and/or the second surgical tool 12 is directly connected to the second moving element 320.
  • the catheter shaft 2 comprises a first distal connection opening 271 and a second distal connection opening 272.
  • the first distal connection opening 271 and the second distal connection opening 272 are in particular formed as recesses in a circumferential area of the catheter shaft 2, through which the first moving element 310 and the second moving element 320 are connected to the first tool-receiving casing 61 and the second tool-receiving casing 62, respectively.
  • the catheter 100 For controlling the movement of the first surgical tool 11 and the second surgical tool 12, the catheter 100 comprises according to figures 1 and 2 a first control means 71 and a second control means 72, respectively.
  • the first surgical tool 11 is controllable by the first control means 71
  • the second surgical tool 12 is controllable by the second control means 72.
  • the first control means 71 is formed as a first control casing 710 and the second control means 72 as a second control casing 720.
  • the first control casing 710 is particularly directly connected to the first moving element 310 and the second control casing 720 to the second moving element 320.
  • Both the first and the second control casings 710, 720 are longitudinally movably, in particular slidably, arranged on the catheter shaft 2.
  • the catheter shaft 2 comprises a first proximal connection opening 261 and a second proximal connection opening 262.
  • the first proximal connection opening 261 and the second proximal connection opening 262 are in particular formed as recesses in a circumferential area of the catheter shaft 2, through which the first moving element 310 and the second moving element 320 are connected to the first control casing 710 and the second control casing 720, respectively.
  • a movement of the first control casing 710 is transmittable by the first moving element 310 to the first surgical tool 11
  • a movement of the second control casing 720 is transmittable by the second moving element 320 to the second surgical tool 12.
  • moving the first control casing 710 in a direction from the proximal shaft end 29 to the distal shaft end 28 causes a movement of the first surgical too! 11 in the same direction.
  • moving the second control casing 720 in the direction from the proximal shaft end 29 to the distal shaft end 28 causes a movement of the second surgical tool 12 in the same direction.
  • the first moving element 310 is arranged in the first moving means receiving lumen 21 in such a way that the first moving element 310 is at least partially circumferentially supported by the catheter shaft wall 20 so that the first surgical tool 11 is movable by the first moving element 310 in the direction from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2.
  • the second moving element 320 is arranged in the second moving means receiving lumen 22 in such a way that the second moving element 320 is at least partially circumferentially supported by the catheter shaft wall 20 so that the second surgical tool 12 is movable by the second moving element 320 in the direction from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2
  • the at least partial circumferential support of the first moving element 310 and the second moving element 320 by the catheter shaft wall 20 enables them, even if they are formed as flexible moving elements, to cause a movement of the first surgical tool 11 and the second surgical tool 12, respectively.
  • the first moving means receiving lumen 21 and the first moving element 310 have the same shape and are each formed in particular as a circular cylinder.
  • the first moving element 310 has a diameter (outer diameter) that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the first moving means receiving lumen 21.
  • figure 5 shows only a part of the catheter shaft wall 20 needed to define and graphically represent the first moving means receiving lumen 21 .
  • the same configuration also applies to the second moving means receiving lumen 22 and the second moving element 320. That is, the second moving means receiving lumen 22 and the second moving element 320 have the same shape and are each formed in particular as a circular cylinder.
  • the second flexible moving element 320 has a diameter (outer diameter) that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the second moving means receiving lumen 22.
  • all surgical tools 11 , 12, 13 are formed as inflatable balloons.
  • the first surgical tool 11 is formed as a first inflatable balloon
  • the second surgical tool 12 as a second inflatable balloon
  • the third surgical tool 13 as a third inflatable balloon.
  • the first moving element 310 is hollow and in fluid communication with the first inflatable balloon.
  • inflating fluid can flow into the first moving element 310 (denoted by arrow 311 in figure 5) and exit through it (denoted by arrow 312 in figure 5) in order to be delivered to the first inflatable balloon.
  • the first tool-receiving casing 61 and the first control casing 710 are each provided with a respective opening in order to enable the flow of the inflating fluid into and out of the first moving element 310.
  • the second moving element 320 is hollow and in fluid communication with the second inflatable balloon.
  • inflating fluid can flow into the second moving element 320 and exit through it in order to reach the second inflatable balloon.
  • the second tool-receiving casing 62 and the second control casing 720 are each provided with a respective opening in order to enable the flow of the inflating fluid into and out of the second moving element 320.
  • the catheter shaft 2 comprises an inflating fluid passing lumen 23.
  • the inflating fluid passing lumen 23 communicates with the third inflatable balloon through an inflating fluid passing opening 230 formed in a circumferential area of the catheter shaft 2.
  • the inflating fluid passing lumen 23 advantageously extends from the proximal shaft end 29 to the position of the third inflatable balloon.
  • the catheter shaft 2 comprises a further lumen 24.
  • the further lumen 24 can be used for receiving a guidewire 200 and/or for passing fluid, for example body fluids, therethrough.
  • the further lumen 24 advantageously extends from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2.
  • figure 3 schematically represents a part of the catheter 100 of figure 2 that extends from the distal shaft end 28 to an area of the catheter shaft 2 between the first distal connection opening 271 and the second proximal connection opening 262. That is why in figure 3 all four lumens 21 , 22, 23 and 24 are shown.
  • Figure 6 refers to a catheter 100 according to a second embodiment of the present invention.
  • the catheter 100 according to the second embodiment differs from the catheter 100 according to the first embodiment in the configuration of the first moving means 31 and the first controls means 71 as well as that of the second moving means 32 and the second control means 72 for moving and controlling the first surgical tool 11 and the second surgical tool 12, respectively.
  • the first moving means 31 and the second moving means 32, and the first control means 71 and the second control means 72 comprise same components, respectively, so that figure 6 refers to the components of said means with regard to both the first surgical tool 11 and the second surgical tool 12. It is noted that figure 6 shows only a part of the catheter shaft wall 20 needed to define and graphically represent the first moving means receiving lumen 21 or the second moving means receiving lumen 22.
  • the first moving means 31 in the catheter 100 of the second embodiment comprises apart from the first moving element 310 a first distal piston 81 and a first proximal piston 91.
  • the first distal piston 81 and the first proximal piston 91 are arranged in the first moving means receiving lumen 21 .
  • a first space 111 between the first distal piston 81 and the first proximal piston 91 is filled with an incompressible fluid. It can be seen from figure 6 that the first moving element 310 is connected to the first distal piston 81.
  • a movement of the first proximal piston 91 in the opposite direction causes due to the build-up of negative pressure in the first space 111 the first distal piston 81 and thus also the first surgical tool 11 to be moved in the direction from the distal shaft end 28 to the proximal shaft end 29.
  • the first surgical tool 11 is pulled by the first moving element 310 towards the proximal shaft end 29.
  • the first control means 71 comprises apart from the first control casing 710 a first control element 711.
  • the first control element 711 can be formed as a stiff control element connected to or formed integrally with the first proximal piston 91.
  • the first control element 711 can be formed as a flexible control element connected to the first proximal piston 91.
  • the first control element 711 is preferably arranged in the first moving means receiving lumen 21 in such a way that the first control element 711 is at least partially circumferentially supported by the catheter shaft wall 20 so that the first proximal piston 91 is movable towards the distal shaft end 28 of the catheter shaft 2 by the first control element 711.
  • the first control element 711 can be formed like the first moving element 310.
  • the first distal piston 81 , the first proximal piston 91 and the first control element 711 are also hollow. Further, a first conduit 121 is arranged between the first distal piston 81 and the first proximal piston 91 and establishes fluid communication between the first moving element 310 and the first control element 711.
  • the second moving means 32 in the catheter 100 of the second embodiment comprises apart from the second moving element 320 a second distal piston 82 and a second proximal piston 92.
  • the second distal piston 82 and the second proximal piston 92 are arranged in the second moving means receiving lumen 22.
  • a second space 112 between the second distal piston 82 and the second proximal piston 92 is filled with an incompressible fluid.
  • the second moving element 320 is connected to the second distal piston 82.
  • a movement of the second proximal piston 92 in the opposite direction causes due to the build-up of negative pressure in the second space 112 the second distal piston 82 and thus also the second surgical tool 12 to be moved in the direction from the distal shaft end 28 to the proximal shaft end 29.
  • the second surgical tool 12 is pulled by the second moving element 320 towards the proximal shaft end 29.
  • the second control means 72 comprises apart from the second control casing 720 a second control element 721.
  • the second control element 721 can be formed as a stiff control element connected to or formed integrally with the second proximal piston 92.
  • the second control element 721 can be formed as a flexible control element connected to the second proximal piston 92.
  • the second control element 721 is preferably arranged in the second moving means receiving lumen 22 in such a way that the second control element 721 is at least partially circumferentially supported by the catheter shaft wall 20 so that the second proximal piston 92 is movable towards the distal shaft end 28 of the catheter shaft 2 by the second control element 721.
  • the second control element 721 can be formed like the second moving element 320.
  • the second distal piston 82 and the second proximal piston 92 are also hollow.
  • the second control element 721 is provided with a respective opening so that fluid communication can be established between the second control element 721 and the second control element 720.
  • a second conduit 112 is arranged between the second distal piston 82 and the second proximal piston 92 and establishes fluid communication between the second moving element 320 and the second control element 721.
  • first moving means 31 and the second moving means 32 of the catheter 100 of the first embodiment or the second embodiment comprise same components, respectively, it is also possible that the first moving means 31 of a catheter 100 according to the present invention is formed like the first moving means 31 of the catheter 100 of the first embodiment and the second moving means 32 like the second moving means 32 of the catheter 100 of the second embodiment or vice versa.
  • first control means 71 and the second control means 72 are also possible.
  • FIGS 7 to 9 show an advantageous application, in which the catheter 100 of the first or the second embodiment of the present invention can be used.
  • the catheter 100 is shown inside a blood vessel 900, in particular the descending aorta, in different states.
  • the first inflatable balloon corresponding to the first surgical tool 11 and the second inflatable balloon corresponding to the second surgical tool 12 are placed at their closest position to the third inflatable balloon corresponding to the third surgical tool 13. It is reminded that the first inflatable balloon and the second inflatable balloon are movably arranged on the catheter shaft 2 of the catheter 100, whereas the third inflatable balloon is fixed on the catheter shaft 2.
  • the first inflatable balloon can be characterised as a proximal balloon, the second inflatable balloon as a distal balloon and the third inflatable balloon as a middle balloon.
  • the first inflatable balloon and the second inflatable balloon are at their furthest position from the third inflatable balloon, while they are still inflated.
  • the catheter 100 can be used as a blood pump, in particular an intra-aortic balloon pump.
  • the doctor first inserts the catheter 100 into the patient’s body, for example through the femoral artery, and forwards the catheter 100 until it reaches the ascending aorta. This is done with all inflatable balloons being deflated (figure 7). At the beginning of or just prior to the next diastolic phase of the heart, the doctor inflates all the inflatable balloons and starts moving the first and second, now inflated, balloons away from each other and from the third, now inflated, balloon (figures 8 and 9).
  • the first inflated balloon and the second inflated balloon act as pistons that push blood to the periphery of the patient’s body.
  • the doctor deflates all the balloons and starts moving the first and second, now deflated, balloons towards the third, now deflated, balloon, in order to prepare for the next diastolic phase of the heart.
  • the inflatable balloons are deflated during the systolic phase of the heart, blood being pumped by the heart can pass by the catheter 100.
  • a cardiac output can greatly be increased, while more parts of the human body can be supplied with blood at the same time.
  • the movement of the first and second inflatable balloons is mechanically supported due to the fixed arrangement of the third inflatable balloon on the catheter shaft 2.
  • Figure 10 shows a catheter 100 according to a third embodiment of the present invention together with an advantageous application of said catheter 100.
  • the catheter 100 according to the third embodiment differs from the catheter 100 according to the first or the second embodiment in that the catheter 100 comprises a plurality of body fluid bypass openings formed in a circumferential area of the catheter shaft 2 proximally to the first inflatable balloon corresponding to the first surgical tool 11.
  • the body fluid bypass openings are in fluid communication with the further lumen 24.
  • the catheter 100 according to the third embodiment can advantageously be used for the treatment of an abdominal aortic aneurysm.
  • An abdominal aortic aneurysm is a localized enlargement of the abdominal aorta such that the diameter is usually greater than 3 cm or more than 50% larger than normal.
  • An abdominal aortic aneurysm usually causes no symptoms, except during rupture.
  • the vessel wall of the abdominal aortic aneurysm is covered by an intraluminal thrombus, which generally does not preclude blood flow.
  • the catheter 100 according to the third embodiment has the great advantage that it can be used by any endovascular surgeon in any medical centre with an angiography suite and immediately stabilizes the patient by stopping the blood loss and restoring blood perfusion to lower limbs and internal organs.
  • an abdominal aortic aneurysm 903 is covered by an intraluminal thrombus 902 and has a rupture 901.
  • the surgeon needs to insert the catheter 100 of the present embodiment into the abdominal aorta, position the first inflatable balloon 11 and the second inflatable balloon 12 at a distal end and a proximal end of the aneurysm 903, respectively, and inflate them, so that the area of the blood vessels 900 comprising the aneurysm 903 is isolated and blood loss through the rupture 901 can be prevented.
  • the third inflatable balloon being arranged between the first and the second inflatable balloons is also inflated in order to better stabilize the catheter 100 inside the aneurysm 903.
  • the catheter 100 does not comprise the third inflatable balloon.
  • Blood flowing in an area proximally to the aneurysm 903 may enter the further lumen 24 (denoted by arrow 904) and exit the further lumen 24 in an area distally to the aneurysm 903 through the plurality of body fluid bypass openings 280 (denoted by the plurality of arrows 905).
  • the body fluid bypass openings 280 can be arranged on the catheter shaft 2 in such a way, that blood can be directed to different parts of the patient’s body.
  • Figures 11 and 12 refer to a catheter 100 according to a fourth embodiment of the present invention.
  • the catheter 100 according to the fourth embodiment differs from the catheter 100 according to the first or second embodiment in that the catheter 100 according to the fourth embodiment comprises only the first surgical tool 11 and the second surgical tool 12 being formed as inflatable balloons.
  • the third surgical tool 13 being an inflatable balloon in the catheter 100 of the first or the second embodiment is here omitted. Due to this, also the inflating fluid passing opening 230 and the corresponding inflating fluid passing lumen 23 are omitted. It is noted that the first moving means 31 , second moving means 32, first control means 71 and second control means 72 can be formed as the ones of the catheter 100 of the first or the second embodiment.
  • the first further lumen 24 preferably communicates with a fluid delivering opening 290 formed in a circumferential area of the catheter shaft 2 between the first surgical tool 11 and the second surgical tool 12.
  • the first further lumen 24 is used as a fluid passing lumen. Therefore, the first further lumen 24 preferably extends from the proximal shaft end 29 to the position of the fluid delivering opening 290.
  • a fluid can be delivered to an area of a body lumen isolated by the first and second inflatable balloons.
  • the second further lumen 24 can be used for receiving a guidewire 200 as well as passing fluid therethrough, when the guidewire 200 is removed.
  • the second further lumen 24 can be characterised as a guidewire receiving and fluid passing lumen 24. Therefore, the second further lumen 24 preferably extends from a proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2.
  • the second further lumen 24 can be used for passing body fluids therethrough.
  • Figures 13 and 14 refer to a catheter 100 according to a fifth embodiment of the present invention.
  • the catheter 100 according to the fifth embodiment differs from that of the first or second embodiment in that the catheter 100 according to the fifth embodiment comprises only one movable surgical tool formed as an inflatable balloon, namely the first surgical tool 11 .
  • the second surgical tool 12 of the catheter 100 in the present embodiment is fixed on the catheter shaft 2.
  • the second surgical tool 12 is also here formed as an inflatable balloon.
  • the second surgical tool 12 of the catheter 100 of the present embodiment corresponds to the third surgical tool 13 of the catheter 100 according to the first or second embodiment.
  • the catheter 100 of the fourth or the fifth embodiment can be used in an angiography procedure explained based on figure 15.
  • a contrast agent is delivered inside the blood vessel 900 through the first further lumen 24 and the fluid delivering opening 290 (denoted by arrows 907).
  • the first inflatable balloon and the second inflatable balloon are inflated. This results in the isolation of the region of interest from the rest of the blood vessel 900. Thereby, the maximum possible concentration of the contrast agent in the isolated region of interest can be achieved.
  • blood flow in the blood vessel 900 is not obstructed, as blood can flow through the second further lumen 24.
  • the second further lumen 24 can be omitted from the catheter 100 according to the fourth or fifth embodiment, as an angiography procedure does not last long and thus it is not crucial to maintain blood flow in the blood vessel 900 during the procedure.
  • the catheter 100 of the fourth or the fifth embodiment can also be used in a thrombolytic procedure explained based on figure 16.
  • An area of the blood vessel 900, in which an intraluminal thrombus 902 has been built up, can be isolated by inflating the first inflatable balloon and the second inflatable balloon.
  • a thrombolytic fluid can directly be delivered to the intraluminal thrombus 902 through the fluid delivering opening 290 communicating with the first further lumen 24 without being washed away by the blood flow in the blood vessel 900.
  • the maximum possible concentration of the thrombolytic fluid in the isolated region of interest can be achieved.
  • An additional advantage of isolating the area of the blood vessel 900, in which the intraluminal thrombus 902 is formed is that the smaller pieces, into which the thrombus 902 is split after the initial effect of the thrombolytic fluid, can remain between the inflated balloons at first. Thus, they can be further reduced in size so that they do not pose a threat for the patient when they return to the normal blood circulation.
  • a plurality of fluid delivering openings 290 can be provided in the circumferential area of the catheter shaft 2, as shown in figure 16.
  • body fluid bypass openings 280 can be provided in the circumferential area of the catheter shaft 2 proximally to the first inflatable balloon in order to obtain a more targeted delivery of blood in the blood vessel 900.
  • a catheter 100 according to a sixth embodiment of the present invention together with an advantageous application of the catheter 100 is presented.
  • a first difference between the catheter 100 according to the sixth embodiment and that of the fourth embodiment is that the first surgical too! 11 in the catheter 100 according to the sixth embodiment is not an inflatable balloon but a stabilizing tool.
  • the first surgical tool 11 is a proximal surgical tool.
  • a second difference lies in that the catheter 100 according to the sixth embodiment comprises only one further lumen 24 that preferably extends from the proximal shaft end 29 to the distal shaft end 28.
  • the further lumen 24 corresponds to the second further lumen 24 of the catheter 100 of the fourth embodiment.
  • the fluid delivering opening 290 and the corresponding further lumen 24 provided in the catheter 100 of the fourth embodiment are omitted in the catheter 100 of the present embodiment.
  • the catheter 100 of the present embodiment can be used in a gastrostomy, which is a surgical procedure used for providing a route for tube feeding if needed for four weeks or longer, and/or to vent the stomach for air or drainage.
  • said route for tube feeding can be provided by the catheter 100 of the present embodiment and in particular from the above-described further lumen 24.
  • the surgeon first inserts the catheter 100 through the abdomen 908 and the stomach 909, until the inflatable balloon corresponding to the second surgical tool 12 (distal surgical tool) is positioned inside the stomach 909. During this step, the inflatable balloon is in its deflated state.
  • the balloon is inflated and the first control casing 710 and the second control casing 720 controlling the movement of the stabilising tool and the balloon, respectively, are manipulated such that the abdomen 908 and the stomach 909 are pressed tightly against each other.
  • the catheter shaft 2 By keeping the first control casing 710 and the second control casing 720 stable and moving the catheter shaft 2 forward, i.e. towards the inner lumen of the stomach 909, the catheter shaft 2, in particular its distal shaft end 28, can be positioned at the region of interest inside the stomach 901. At the same time, the abdomen 908 and the stomach 909 can maintain their position relative to each other.
  • food can be provided through the further lumen 24 to the stomach.
  • Figure 19 shows a catheter 100 according to a seventh embodiment of the present invention.
  • the catheter 100 according to the seventh embodiment differs from the catheter 100 according to the fourth embodiment in that the second surgical tool 12 of the catheter 100 of the seventh embodiment is not an inflatable balloon but a cutting device.
  • the cutting device is formed as an atherectomy blade used for cutting away an atheroma in a blood vessel.
  • the doctor inserts the catheter 100 in the blood vessel, while the inflatable balloon corresponding to the first surgical tool 11 is in its deflated state.
  • the doctor Inflates the inflatable balloon, thereby anchoring it to the wall of the blood vessel. Then, the catheter shaft 2 is pushed towards the atheroma. The force, with which the catheter shaft 2 is pushed, is transferred close to the tip 202 of the catheter shaft 2 and therefore also to the atherectomy blade being fixed to the catheter shaft 2 close to the tip 202.
  • the atheroma can easily be cut away from the blood vessel.
  • Figure 20 shows an inflatable balloon (medical balloon) 1000 directly arranged on a catheter shaft 2. That is, the inflatable balloon 1000 is not fixed to a tool-receiving casing being longitudinally movably arranged on the catheter shaft 2, but is itself longitudinally movably arranged on the catheter shaft 2.
  • the inflatable balloon 1000 advantageously has a form that completely surrounds the catheter shaft 2.
  • the inflatable balloon is barrel-shaped.
  • the inflatable balloon 1000 can also have other forms, e.g. be formed as donut or a hollow cylinder.
  • the first inflatable balloon corresponding to the first surgical tool 11 and/or the second inflatable balloon corresponding to the second surgical tool 12 of the previously described embodiments can also be directly arranged on the catheter shaft 2 in a movable manner like the balloon 1000 of figure 20.
  • the first moving element 310 and/or the second moving element 320 is/are directly connected to the first inflatable balloon and/or the second inflatable balloon via the first distal connection opening 271 and/or the second distal connection opening 272, respectively.
  • Figure 21 shows another example of an inflatable balloon (medical balloon) 1000.
  • the inflatable balloon 1000 comprises two channels 1003 that extend from a proximal balloon end 1001 to a distal balloon end 1002 for allowing a flow of fluid therethrough in its inflated state.
  • the channels 1003 are formed as recesses in a circumferential area of the balloon 1000.
  • the channels 1003 are formed such that fluid can flow substantially in one direction or only in one direction through each channel 1003.
  • a first channel cross-section (cross-sectional area) at a first channel end 1006 of each channel 1003 is larger than a second channel cross-section (cross-sectional area) at a second channel end 100/ ot the corresponding channel 1003.
  • the first channel end 1006 corresponds to a proximal channel end and the second channel end 1007 response to a distal channel end.
  • each channel 1003 has a tapered form between the first channel cross-section and the second channel cross-section, in other words between the proximal channel end and the distal channel end.
  • the inflatable balloon 1000 further comprises an arranging region 1005 for arranging the medical balloon the component of the catheter.
  • the component can be a tool-receiving casing arranged on a catheter shaft of the catheter or the catheter shaft itself.
  • Figure 22 shows another example of an inflatable balloon (medical balloon) 1000.
  • the difference between the balloon 1000 of figure 22 and that of figure 21 is that the channels 1003 of the balloon 1000 of the present example are not formed as recesses in the circumferential area of the balloon 1000, but extend through an inner space of the balloon 1000.
  • One of the channels 1003 has a tapered formed between the first channel cross-section and the second channel cross-section, in other words between the proximal channel end and the distal channel end.
  • fluid can flow, depending on the ratio of the first cross-section to the second cross-section, substantially or only in the direction from the proximal channel end to the distal channel end of the channel 1003.
  • the other channel 1003 has a cylindrical form, but is provided with a one-way valve 1008 at its distal channel end.
  • the one-way valve can be formed for example as a flap.
  • fluid can flow only in the direction from the proximal channel end to the distal channel end of the channel 1003.
  • first inflatable balloon corresponding to the first surgical tool 11 and/or the second inflatable balloon corresponding to the second surgical tool 12 and/or the third inflatable balloon corresponding to the third surgical tool 13 of the previously described embodiments can be formed as the balloon 1000 of figures 21 and 22.

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Abstract

The present inventions refers to a catheter, comprising a catheter shaft (2) that extends along a longitudinal axis (500), a first surgical tool (11), a first moving means (31) and a second surgical tool (12). The first surgical tool (11) and the second surgical tool (12) are movable relative to each other in the direction of the longitudinal axis (500). The first surgical tool (11) is movable on the catheter shaft (2) in the direction of the longitudinal axis (500) by the first moving means (31). The second surgical tool (12) may be movable on the catheter shaft (2) in the direction of the longitudinal axis (500) by a second moving means (32) or fixed on the catheter shaft (2).

Description

CATHETER
Description
The present invention refers to a catheter. The catheter of the present invention can also be characterized as a medical catheter.
Catheters have been used for years in many medical applications for humans and animals, as they provide access to the body in a minimally invasive way.
For example, catheters are widely used in most endovascular applications. Due to their minimal invasive character, the treatment of blood vessel pathologies can be achieved without considerable postoperative pain and the need of a general anaesthesia during the operation or a long hospitalization of the patient. An endovascular catheter is known from WO 2016 203277 A1.
It is an object underlying the present invention to suggest a compact catheter with a high design flexibility that can be used in a variety of medical applications.
The solution to said object is achieved by a catheter with the combination of features of the independent claim. The dependent claims contain advantageous embodiments and aspects of the invention.
In particular, the catheter comprises a catheter shaft, a first surgical tool, a second surgical tool and a first moving means. The catheter shaft extends along a longitudinal axis. The first surgical tool and the second surgical tool are movable relative to each other in the direction of the longitudinal axis. The first surgical tool is movable on the catheter shaft in the direction of the longitudinal axis by the first moving means. The second surgical tool may be movable on the catheter shaft in the direction of the longitudinal axis by a second moving means or fixed on the catheter shaft.
In other words, the first surgical tool and the second surgical tool are arranged on the catheter shaft and are movable relative to each other in the direction of the longitudinal axis. Here, the first surgical tool is movably arranged on the catheter shaft. The first moving means is configured to move the first surgical tool on the catheter shaft in the direction of its longitudinal axis. The second surgical tool may be either movably arranged or fixed on the catheter shaft. When the second surgical tool is movably arranged on the catheter shaft, a second moving means is configured to move the second surgical tool on the catheter shaft in the direction of its longitudinal axis. Thus, by providing a first moving means and a second moving means, the first surgical tool and the second surgical tool can be moved independently from each other. It is apparent that for moving the first surgical tool, the first moving means is connected to the first surgical tool. Accordingly, in order to move the second surgical tool, the second moving means is connected to the second surgical tool.
The catheter of the present invention having two surgical tools, which are controllably movable relative to each other, has the advantage that a distance between the two surgical tools can controllably be adjusted. Further, the position of the first surgical tool relative to the catheter shaft can also be adjusted. Especially when both surgical tools, namely the first and the second surgical tool, are movable, a more precise adjustment of the distance between the two surgical tools as well as of the position of each of the surgical tools relative to the catheter shaft can be achieved. Depending on the initial relative distance between the two surgical tools when they are both located at their proximal position and on the ranges of their movement in the longitudinal direction of the catheter shaft, the catheter can be used in various medical applications as well as in patients with different anatomical characteristics and/or a different clinical condition. Further advantages such as the isolation of a part of a body lumen, the increase of the catheter’s most important characteristics such as the pushability, trackability and crossability, the stabilization of a body region or the application of force to one or more body regions can be achieved by appropriately choosing the first surgical tool and the second surgical tool. The catheter of the present invention can advantageously be used as an endovascular, a gastrointestinal or a urological catheter.
Preferably, the first surgical tool is a proximal surgical tool and the second surgical tool a distal surgical tool. This means that the first surgical tool is preferably closer to a proximal shaft end than the second surgical tool is to the proximal shaft end. In other words, the second surgical tool is preferably closer to a distal shaft end than the first surgical tool is to the distal shaft end.
It is noted that the catheter of the present invention may comprise more than two surgical tools, namely further surgical tools apart from the first surgical tool and the second surgical tool . Also in this case, like in the case of the catheter having the first surgical tool and the second surgical tool, it is sufficient for achieving the aforementioned advantages for the catheter of the present invention if at least one of the surgical tools is longitudinally movably arranged on the catheter shaft.
Preferably, the catheter further comprises a third surgical tool that is fixed on the catheter shaft. According to an advantageous embodiment of the present invention, the first surgical tool and the second surgical tool are movably arranged on the catheter shaft and the third surgical tool is fixed on the catheter shaft.
Preferably, the third surgical tool is arranged between the first surgical tool and the second surgical tool. Any of the surgical tools of the catheter, in particular the first surgical tool and/or the second surgical tool and/or the third surgical tool, can each be formed as an inflatable balloon, a cutting device, a stent, a stabilizing tool, a pressure sensor or any other tool that can be used in a surgical procedure, in which a catheter is used. The cutting device can in particular be a blade, for example an atherectomy blade, or a Fallopian tube scraping wire (curretage wire for uterine curettage). In the framework of the present invention, any combination of the aforementioned tools is possible. However, it is most preferable that at least one of the surgical tools is an inflatable balloon.
In this respect, it is most preferred if the first surgical tool being movably arranged on the catheter shaft is an inflatable balloon. The catheter with the first surgical tool being an inflatable balloon has in addition to the advantage of the adjustment of the position of the balloon relative to the second surgical tool and to the catheter shaft the advantage of improving the characteristics of the catheter. This will be described in more detail in the following.
When the inflatable balloon is inflated inside a body lumen, the balloon is anchored to the wall defining the lumen and thus cannot be moved with respect to said wall. Therefore, applying a force to the first moving means is translated to a movement of the catheter shaft relative to the balloon. In particular, with the help of the inflatable balloon, the catheter may acquire greater pushability, since the needed propulsive force for moving the catheter shaft forward can be applied close to its tip. The term “pushability” means the degree in which the force transmitted from a proximal shaft end part of the catheter shaft is translated into movement of a distal shaft end part (tip) of the catheter shaft, which depends on the transmission of the force along the body of the catheter shaft. In other words, the term “pushability” means the ease of advancing the catheter inside a lumen, e.g. a blood vessel, and is indicative of the amount of force the distal shaft end part of the catheter shaft sees when a known force is being applied to the proximal end part of the catheter shaft. With respect to crossability, i.e. the ability to navigate the tip of the catheter shaft across narrow restrictions in the vasculature, the suggested catheter can be moved through a significant stenosis with greater force by using the propulsive force applied by the moving balloon when pushing the tip of the catheter shaft. When a guidewire is further provided in the catheter, the catheter can offer maximal backup support to the guidewire and in addition, the greatest possible pushability, crossability and trackability over the guidewire in narrowed or blocked lumens and passages of the patient’s body. More specifically, the catheter shaft can provide backup support to the guidewire in the effort to move it through anatomically difficult areas of lumens of the human body, while - at the same time - it can be accurately repositioned, keeping the balloon inflated and anchored within the lumen. In particular, the trackability of the catheter shaft over the guidewire is high, since once again the propulsive force of the balloon moving close to the tip of the catheter shaft is much greater. This is specifically advantageous in tortuous lumens, where the crossing of the catheter is hindered due to the multiplication of the friction between the catheter shaft and the lumen walls as well as between the catheter shaft and the guidewire caused by the existing tortuosity.
When in addition to the first surgical tool being formed as an inflatable balloon the second surgical tool is for example a cutting device such as an atherectomy blade fixed on the catheter shaft, the improvement of the catheter’s characteristics as described above results in in the cutting device being able to cut with more force. The reason for this is that applying a pushing force to the balloon by the first moving means when the balloon is inflated and thus anchored to the walls of a body lumen is translated into a forward movement of the catheter shaft with a high force and thus to a forward movement with a high force also of the cutting device.
If, according to another embodiment of the catheter, the first surgical tool is formed as a first inflatable balloon and the second surgical tool as a second inflatable balloon fixed or movably arranged on the catheter shaft, the improvement of the catheter’s characteristics as described above results in the ability of the catheter shaft to be forwarded through narrowed passages of the patient’s body in order to place the second inflatable balloon at the position of the stenosis. The second inflatable balloon can advantageously be positioned inside the stenosis and then inflated in order to widen the narrowed passage.
According to an advantageous embodiment, the first surgical tool, the second surgical tool and the third surgical tool of the catheter are inflatable balloons. Here, it is preferable that the third surgical tool being fixed on the catheter shaft is arranged between the first surgical tool and the second surgical tool. The use of a catheter with such a configuration can provide results of paramount importance for the survival of a patient in the case of treating an abdominal aortic aneurysm.
When the third surgical tool is an inflatable balloon, the catheter shaft preferably comprises an inflating fluid passing lumen that communicates with the inflatable balloon through an inflating fluid passing opening formed in a circumferential area of the catheter shaft. Thus, the third surgical tool can be provided with inflating fluid through the inflating fluid passing lumen. If the catheter comprises a plurality of inflatable balloons fixed on the catheter shaft, the same inflating fluid passing lumen can be used for delivering inflating fluid to some or all of the inflatable balloons. In this case, a plurality of inflating fluid passing openings is formed in the circumferential area of the catheter shaft, wherein the corresponding inflating fluid passing openings are in communication with the inflating fluid passing lumen. Alternatively, the catheter may comprise one (separate) inflating fluid passing lumen per inflatable balloon. According to another embodiment of the present invention, the first surgical tool is formed as an inflatable balloon and the second surgical tool is fixed to the catheter shaft and formed as a cutting device.
According to another embodiment of the present invention, the first surgical tool is formed as a stabilizing tool and the second surgical tool is a movable surgical tool and formed as an inflatable balloon.
Preferably, the first moving means comprises a first moving element.
Advantageously, the first moving element is flexible, connected to the first surgical tool and arranged in a first moving means receiving lumen defined by a catheter shaft wall. The first moving element is arranged in the first moving means receiving lumen in such a way that the first moving element is at least partially circumferentially supported by the catheter shaft wall so that the first surgical tool is movable by the first moving element in a direction from a proximal shaft end to a distal shaft end of the catheter shaft.
When the first surgical tool is formed as a first inflatable balloon, the first moving element is preferably hollow and in fluid communication with the first inflatable balloon.
When the second surgical tool is a movable surgical tool being movable on the catheter shaft in the direction of the longitudinal axis by the second moving means, the second moving means preferably comprises a second moving element.
Advantageously, the second moving element is flexible, connected to the second surgical tool and arranged in a second moving means receiving lumen defined by a catheter shaft wall. The second moving element is arranged in the second moving means receiving lumen in such a way that the second moving element is at least partially circumferentially supported by the catheter shaft wall so that the second surgical tool is movable by the second moving element in a direction from a proximal shaft end to a distal shaft end of the catheter shaft.
By being at least partially circumferentially supported by the catheter shaft wall as described above, the first/second moving element is/are movable in such a way that its movement causes a movement of the first/second surgical tool. In other words, the first/second moving element is/are arranged in a way that it/they is/are laterally supported by the catheter shaft wall so that the first/second moving element, even though being itseif/themselves bendable, can push the first/second surgical tool. Should not have been for the circumferential support of the first/second moving element provided by the catheter shaft wall, the first/second moving element would, at least partially, bend when being moved in the direction from the proximal shaft end to the distal shaft end of the catheter shaft, i.e. pushed, and thus would not be able to move the first/second surgical tool. To put it differently, the first/second moving element is/are advantageously confined by the catheter shaft wall so that the first/second moving element functions as a stiffer element when being pushed, so that the first/second moving element can transmit its movement to the first/second surgical tool. Thus, the catheter shaft wall acts as a restriction and support element for the first/second moving element so that the first/second moving element is/are supported throughout its/their movement in the first/second moving means receiving lumen such that this movement results in a corresponding movement of the first/second surgical tool. In particular, the catheter shaft wall provides to the first/second moving element the stiffness that the first/second moving element inherently lacks/lack and hence needs/need in order to be able to move the first/second surgical tool. However, the first/second moving element is/are capable of being bent, when the catheter, in particular the catheter shaft, is forwarded through curved paths, e.g. tortuous blood vessels, of the body of a patient.
The above-described arrangement of the first/second moving element for moving the first/second surgical tool has the advantage that the catheter may have a compact structure, as it is sufficient that the catheter shaft comprises only one moving means receiving lumen per movable surgical tool. More specifically, the present invention allows for a reduction of a maximum outer dimension, in particular a maximum outer diameter, of the catheter/catheter shaft compared to a catheter with a catheter shaft requiring two moving means receiving lumens per movable surgical tool. This in turn has the advantage that the catheter can be used in a large variety of applications and more particularly in applications where blood vessels, lumens and cavities of small dimensions of a human or animal body should be accessed. By requiring only one moving means receiving lumen per movable surgical tool, a catheter with the same maximum outer dimension, in particular the same maximum outer diameter, can be provided with more surgical tools than a catheter that requires two moving means receiving lumens per movable surgical tool. Furthermore, the catheter provides a great flexibility in view of the spatial arrangement of the moving means receiving lumen(s) with respect to any further lumen(s) that might be formed in the catheter shaft, such as a lumen for transferring fluids therethrough and/or receiving a guidewire.
Further, due to the flexible nature of the first moving element, and in particular of also the second moving element, when the second surgical tool is a movable surgical tool, the catheter can be still bent as a whole. Thus, the first/second moving element does/do not alter the flexible nature of the catheter as a whole. It is noted that in the framework of the present invention, a catheter is in particular understood as a device having a flexible (catheter) shaft for insertion into a body cavity, duct, canal, vessel or passageway of a patient and being configured to deliver to or withdraw fluids from a patient through its catheter shaft and/or distend a passageway and/or place a surgical tool at a target site inside the patient’s body in order to cause a modification of the body cavity, duct, canal, vessel or passageway.
Advantageously, the first/second surgical tool is/are connected to the first/second moving element at a distal portion and/or distal end of the first/second moving element.
Preferably, the flexibility of the first/second moving element is such that a flexibility of the catheter shaft and/or the catheter with the first/second moving element is not more than 20%, preferably not more than 10%, most preferably not more than 5%, different, in particular larger, than a flexibility of the catheter shaft and/or the catheter without the first/second moving element.
When the second surgical tool is formed as a second inflatable balloon, the second moving element is preferably hollow and in fluid communication with the second inflatable balloon.
Here, the first surgical tool may preferably be controllable by a first control means that is connected to the first moving element.
In particular, the first control means may advantageously comprise a first control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to the first moving element. The first control casing is the component that a doctor using the catheter manipulates in order to control the first surgical tool. The first moving element may be connected directly to the first control casing. Alternatively, the first control means may comprise a first control element by which the first moving element is connected to the first control casing and which is formed as a stiff control element. However, it is also possible that the first control means comprises the aforementioned first control element without the first control casing. In this case, the first control element is the component that a doctor using the catheter manipulates in order to control the first surgical tool.
Preferably, the first control casing is connected to the first moving element via a first proximal connection opening.
Accordingly, the second surgical tool may preferably be controllable by a second control means that is connected to the second moving element.
In particular, the second control means may advantageously comprise a second control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to the second moving element. The second control casing is the component that a doctor using the catheter manipulates in order to control the second surgical tool. The second moving element may be connected directly to the second control casing. Alternatively, the first control means may comprise a second control element by which the second moving element is connected to the second control casing and which is formed as a stiff control element. However, it is also possible that the second control means comprises the aforementioned second control element without the second control casing. In this case, the second control element is the component that a doctor using the catheter manipulates in order to control the second surgical tool.
In addition to the first moving element, the first moving means may preferably further comprise a first distal piston and a first proximal piston, which are arranged in the first moving means receiving lumen. A first space between the first distal piston and the first proximal piston is filled with an incompressible fluid. Here, the first moving element is further connected to the first distal piston. The first moving element is arranged in the first moving means receiving lumen in such a way that the first moving element is at least partially circumferentially supported by the catheter shaft wall so that a movement of the first proximal piston in a direction from the proximal shaft end of the catheter shaft to the distal shaft end of the catheter shaft causes a movement of the first surgical tool. This means that the arrangement of the first moving element in the first moving means receiving lumen is such that a movement of the first proximal piston being transferred to the first distal piston via the incompressible fluid can be transferred to the first surgical tool via the first moving element.
Apart from the second moving element, the second moving means may preferably further comprise a second distal piston and a second proximal piston, which are arranged in the second moving means receiving lumen. A second space between the second distal piston and the second proximal piston is filled with an incompressible fluid. Here, the second moving element is further connected to the second distal piston. The second moving element is arranged in the second moving means receiving lumen in such a way that the second moving element is at least partially circumferentially supported by the catheter shaft wall so that a movement of the second proximal piston in a direction from the proximal shaft end of the catheter shaft to the distal shaft end of the catheter shaft causes a movement of the second surgical tool. This means that the arrangement of the second moving element in the second moving means receiving lumen is such that a movement of the second proximal piston being transferred to the second distal piston via the incompressible fluid can be transferred to the second surgical tool via the second moving element.
The advantages presented above in view of the first/second flexible movement also apply to the embodiment of the catheter using an incompressible fluid between two pistons for transmitting a movement is advantageous as a controlled transmission of the movement between the pistons can be achieved. In addition, a length of the first/second space filled with the incompressible fluid and a length of the first/second moving element in the direction of the longitudinal axis of the catheter shaft can be adapted to the application for which the catheter is intended. For example, the first/second space filled with the incompressible fluid can be chosen such that the first/second moving element has a smaller length, if the catheter is made to be used in lumens with large tortuosity. On the other hand, the length of the first/second flexible element can be chosen to be shorter, if tortuous lumens should be accessed with the catheter. Further, the force being transferred from the first/second proximal piston to the first/second distal piston is independent from the speed of movement of the first/second proximal piston. As an incompressible fluid, water or a water solution can be used for filling the first/second space between the pistons.
It is noted that a movement of the first/second proximal piston in a direction from the distal shaft end of the catheter shaft to the proximal shaft end of the catheter shaft effects a corresponding movement of the first/second surgical tool as the movement of the first/second proximal piston results in a build up of negative pressure in the first/second space between the first/second proximal piston and the first/second distal piston, what in turn causes the fluid and the first/second distal piston to be moved/pulled in the same direction with the first/second proximal piston. The movement of the first/second distal piston is then transferable to the first/second moving element, which in turn pulls the first/second surgical tool connected thereto.
It is further noted that the terms “proximal piston” and “distal piston” with regard to the first and second proximal pistons and the first and second distal pistons, respectively, mean that the respective proximal piston is closer to the proximal shaft end of the catheter shaft than the respective distal piston is to the proximal shaft end. In other words, the respective distal piston is closer to the distal shaft end of the catheter shaft than the respective proximal piston is to the distal shaft end.
In addition to the first moving element being hollow, when the first surgical tool is formed as a first inflatable balloon, the first distal piston and the first proximal piston are advantageously also hollow. Moreover, in addition to the first moving element being in fluid communication with the first surgical tool, the first moving element is preferably also in fluid communication with a first conduit that is arranged between the first distal piston and the first proximal piston.
In addition to the second moving element being hollow, when the second surgical tool is formed as a second inflatable balloon, the second distal piston and the second proximal piston are advantageously also hollow. Moreover, in addition to the second moving element being in fluid communication with the second surgical tool, the second moving element is preferably also in fluid communication with a second conduit that is arranged between the second distal piston and the first proximal piston.
At this point, it is noted that the term “at least partially” in the corresponding expressions “at least partially circumferentially supported” presented above in connection to the first/second moving element refers to the term "circumferentially". This means that the first/second moving element is/are supported at least over a part of its whole circumference at a given cross-section. In particular, the first/second moving element can be supported over its/their whole circumference at a given cross-section. Moreover, it is noted that the at least partial circumferential support provided by the catheter shaft wall defining the first/second moving means receiving lumen means in particular that the support is provided by an inner portion, preferably an inner surface, of the catheter shaft wall facing the first/second moving means receiving lumen.
Preferably, the first/second moving element is/are completely circumferentially supported by the catheter shaft wall. This means that the first/second moving element is supported over its/their whole circumference at a given cross-section.
Advantageously, the first/second moving element is/are longitudinally movably arranged in the first/second moving means receiving lumen. More particularly, the first/second moving element is/are extractably arranged in the first/second moving means receiving lumen. This means that the first/second moving element can be moved out of the first/second moving means receiving lumen due to the at least partial circumferential support by catheter shaft wall so that the first/second moving element can move the surgical tool.
The first/second moving means receiving lumen may preferably be configured such that it/they provides/provide over only a portion of its/their length or over its/their whole length the at least partial circumferential support to the first/second moving element.
The first/second moving element is/are advantageously flexible over its/their whole length. Furthermore, a flexibility of the first/second moving element may vary along its length. This allows the first/second moving element to be adapted to a respective application of the catheter.
In the embodiment of the catheter having the first proximal piston and the first distal piston as described above, the first surgical tool is preferably controllable by a first control means connected to the first proximal piston.
The first control means preferably comprises a first control element. According to an embodiment, the first control element is formed as a stiff control element connected to or formed integrally with the first proximal piston. According to an alternative embodiment, the first control element is formed as a flexible control element connected to the first proximal piston and arranged in such a way that the first control element is at least partially circumferentially supported by the catheter shaft wall so that the first proximal piston is movable towards the distal shaft end of the catheter shaft by the first control element. In particular, the first control means preferably further comprises a first control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to first control element. Preferably, the first control element is connected to the first control casing via a first proximal connection opening.
In the embodiment of the catheter having the second proximal piston and the second distal piston as described above, the second surgical tool is preferably controllable by a second control means connected to the second proximal piston.
The second control means preferably comprises a second control element. According to an embodiment of the invention, the second control element is formed as a stiff control element connected to or formed integrally with the second proximal piston. According to an alternative embodiment, the second control element is formed as a flexible control element connected to the second proximal piston and arranged in such a way that the second control element is at least partially circumferentially supported by the catheter shaft wall so that the second proximal piston is movable towards the distal shaft end of the catheter shaft by the second control element. In particular, the second control means preferably further comprises a second control casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft and connected to second control element. Preferably, the second control element is connected to the second control casing via a second proximal connection opening,
Preferably, a maximum cross-sectional area or a maximum outer dimension of the first moving element may be at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a minimum cross- sectional area or of a minimum inner dimension of the first moving means receiving lumen, respectively.
Accordingly, a maximum cross-sectional area or a maximum outer dimension of the second moving element may be at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a maximum cross-sectional area or of a minimum inner dimension of the second moving means receiving lumen.
It is preferred that at least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between a first end position and a second end position of the first/second flexible moving element has a cross-sectional area over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a cross-sectional area of the first/second moving means receiving lumen. Most preferably, the first/second flexible moving element has over its whole length a cross- sectional area that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a cross- sectional area of the first/second moving means receiving lumen.
In particular, when the first/second moving means receiving lumen and at least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and second end positions of the first/second flexible moving element are each formed as a circular cylinder, it is preferred that at least said first/second flexible moving element portion has over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, a diameter that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the first/second moving means receiving lumen.
Most preferably, when the first/second moving means receiving lumen and the whole flexible first/second moving element are each formed as a circular cylinder, it is preferred that the first/second flexible moving element has over its whole length a diameter that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the first/second moving means receiving lumen. Advantageously, a fit between the first/second flexible moving element and the first/second moving means receiving lumen is a clearance fit.
It is noted that when referring to the shape of a portion or the whole of the first/second flexible moving element, the shape of a main body of the first/second flexible moving element that extends in the direction of its longitudinal axis, without taking into account any potential protrusions that may act as connecting portions of the flexible moving element with a further component of the catheter, i.e. when the first/second flexible moving element substantially extends along its longitudinal axis, is in particular meant within the scope of the present invention. Thus, a length of a portion or the whole of the first/second flexible moving element means in particular a length of the portion or the whole of the flexible moving element in the direction of its longitudinal axis, respectively.
It is further noted that the term “at least the first/second flexible moving element portion” means in particular the portion of the first/second flexible moving portion, that is arranged in the lumen during its movement from the first end position to the second end position or vice versa.
By choosing the dimensional relationship of the first/second flexible moving element and the first/second moving means receiving lumen as presented, it can be ensured that most of the force with which the first/second flexible moving element is pushed can be transferred to the first/second surgical tool and cause it to move, in particular be pushed. The term “substantially” in connection with the terms “cross-sectional area” and/or “diameter” means in particular that the first/second moving means receiving lumen and the first/second flexible moving element are produced within the technical tolerances of the method(s) used to manufacture said elements.
Preferably, at least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and the second end positions of the first/second flexible moving element has over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, the same shape with the first/second moving means receiving lumen. Most preferably, the first/second flexible moving element has over its whole length the same shape with the first/second moving means receiving lumen.
Preferably, the first/second flexible moving element is arranged in the first/second moving means receiving lumen in such a way that the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and the second end positions of the first/second flexible moving element has over at least a part of its whole length, i.e. over only a part of its whole length or over its whole length, a shape that is complementary to a shape of the first/second moving means receiving lumen. For example, if both the first/second flexible moving element and the first/second moving means receiving lumen have an elliptical cross-section, the first/second flexible moving element is arranged in the first/second moving means receiving lumen in such a way that a major axis and a minor axis of the first/second flexible moving element are aligned with a major axis and a minor axis of the first/second moving means receiving lumen, respectively.
According to an advantageous embodiment, at least the first/second flexible moving element portion that is movably arranged or arrangeable/movable in the first/second moving means receiving lumen between the first and the second end positions of the first/second flexible moving element, in particular the whole first/second flexible moving element, is formed as a circular cylinder.
Preferably, the first/second moving means receiving lumen is formed as a circular cylinder. The first surgical tool may preferably be connected directly to the first moving element and directly arranged on the catheter shaft. Alternatively, the first surgical tool can be arranged on, in particular fixed to, a first tool-receiving casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft, and connected to the first moving element. The first tool-receiving casing is arranged between the first flexible moving element and the first surgical tool. In addition, the first surgical tool can also be directly connected to the first moving element. The second surgical tool is preferably connected directly to the second moving element and directly arranged on the catheter shaft. Alternatively, the second surgical tool can be arranged on, in particular fixed to, a second tool-receiving casing that is longitudinally movably, in particular slidably, arranged on the catheter shaft, and connected to the second moving element. The first tool-receiving casing is arranged between the second flexible moving element and the second surgical tool. In addition, the second surgical tool can also be directly connected to the second moving element.
Advantageously, the first surgical tool is connected to the first moving means via a first distal connection opening formed in a circumferential area of the catheter shaft.
When the second surgical tool is movable on the catheter shaft in the direction of the longitudinal axis by the second moving means, the second surgical tool is advantageously connected to the second moving means via a second distal connection opening formed in a circumferential area of the catheter shaft.
Preferably, any movable surgical tool provided in the catheter is connected to its corresponding moving means via a corresponding distal connection opening formed in the circumferential area of the catheter shaft. In this case, the number of movable surgical tools is equal to the number of moving means and to the number of the distal connection openings.
Preferably, the catheter shaft further comprises at least one further lumen for receiving a guidewire and/or passing a substance, in particular, fluid therethrough, e.g. for delivering a fluid to a site of interest in the patient’s body and/or removing body or other fluids from the patient’s body. It is also possible that the at least one further lumen comprises at least one guidewire receiving lumen and at least one substance passing lumen as separate lumens. The catheter together with a guidewire can be characterized as a catheter assembly.
The at least one further lumen advantageously extends over a whole length of the catheter shaft. In other words, a proximal end and a distal end of the at least one further lumen correspond to a proximal shaft end and a distal shaft end of the catheter shaft, respectively. Alternatively, the at least one further lumen may extend a partial length of the catheter shaft.
According to an advantageous embodiment of the present invention, the catheter shaft comprises at least one body fluid bypass opening. The at least one body fluid bypass opening is formed in a circumferential area of the catheter shaft and is in fluid communication with the at least one further lumen. The at least one body fluid bypass opening is arranged proximally to the first surgical tool, the first surgical tool being closer to the proximal shaft end of the catheter shaft than the second surgical tool (is to the proximal shaft end). In other words, the first surgical tool and the second surgical tool are compared to each other a proximal surgical tool and a distal surgical tool, respectively. The first surgical tool and the second surgical tool are inflatable balloons. This configuration allows body fluids to distally enter the at least one further lumen and to proximally exit the at least one further lumen through the at least one body fluid bypass opening. Thereby, body fluids that flow in the body lumen in which the catheter is positioned can bypass the portion of the body lumen between the two inflatable balloons when these are inflated. The exact position of the at least one body fluid bypass on the catheter shaft can be chosen according to the medical application for which the catheter is intended. Thus, a part of the body fluids can exit the at least one further lumen at a desired position, while the rest of the body fluids can exit the at least one further lumen through an opening formed at the distal shaft end of the catheter shaft. In particular, the catheter shaft may comprise a plurality of body fluid bypass openings. The body fluid bypass openings can preferably be spaced from each other in the direction of the longitudinal axis and/or in a circumferential direction of the catheter shaft. Thus, a part of the body fluids can be more evenly distributed proximally to the first surgical tool being formed as a balloon. It is noted that the body fluids can distally enter the at least one further lumen through an opening formed at the distal shaft end of the catheter shaft and/or at least one opening, in particular a plurality of openings, formed in a circumferential area of the catheter shaft distally to the second surgical tool being formed as a balloon.
According to an advantageous embodiment of the present invention, the catheter shaft comprises at least one fluid delivering opening formed in a circumferential area of the catheter shaft and being in fluid communication with the at least one further lumen. Thus, a fluid can be delivered in a targeted manner to a specific part of the patient’s body through the at least one fluid delivering opening.
In particular, the catheter shaft may comprise a plurality of fluid delivering openings. Thus, depending on the arrangement of the fluid delivering openings in the circumferential area of the catheter shaft, a more targeted supply of fluid at several positions in the patient’s body can be achieved. The fluid delivering openings can preferably be spaced from each other in the direction of the longitudinal axis and/or in a circumferential direction of the catheter shaft.
Preferably, the at least one fluid delivering opening is arranged between the first surgical too! and the second surgical tool, when the first surgical tool and the second surgical tool are inflatable balloons. Thus, a fluid can be delivered to a part of the patient’s body between the balloons that can be isolated when the balloons are inflated. Thereby, the fluid can be provided only to the isolated part without mixing with any body fluids. For example, the fluid can be a medicament or a contrast agent.
The first/second moving element is/are preferably formed as a wire. The term “wire” may also comprise a cable or any other flexible rod-shaped element. However, the first/second moving element can be any element that can be bent, so that the catheter can be bent as a unit, when being forwarded through lumens and cavities of hollow organs of a patient's body.
The first/second control element when being flexible is/are preferably formed as a wire. The term “wire" may also comprise a cable or any other flexible rod-shaped element. However, the first/second control element when being flexible can be any element that can be bent, so that the catheter can be bent as a unit, when being forwarded through lumens and cavities of hollow organs of a patient’s body.
The first/second moving element and/or the first/second control element may be made for example from metal, plastic or a composite material.
In the framework of the present invention, the term “flexible" describing a component of the catheter, in particular the first/second moving element or the first/second control element when being formed as a first/second flexible control element, means advantageously that the respective component is bendable by its own weight. In other words, the term “flexible” means that the respective component cannot support/carry/bear its own weight without being bent when it is fixed at one of its ends and the other end is free. It is noted, however, that bending does not mean that the respective component collapses due its own weight when it is fixed at one of its ends and the other end is free. In other words, the flexible component may only partially carry its own weight. Accordingly, in the framework of the present invention, the term “stiff" describing a component, in particular the first/second control element when formed as a first/second stiff control element, advantageously means that the first/second control element is not bendable by its own weight. In other words, the term “stiff” means that the first/second control element can support/carry/bear its own weight without being bent when it is fixed at one of its ends and the other end is free.
Within the framework of the present invention, the term “moving means” can in particular be replaced by the term “movement transmitting means”. By the term “movement transmitting means”, a means for transmitting a movement of the hand of a doctor or a movement of the control means, if such a control means is present in the catheter, being moved by a doctor using the catheter to the respective surgical tool is understood. In particular, within the scope of the present invention, a movement transmitting means can also be understood as a force transmitting means for transmitting a force applied thereto, by the doctor using the catheter, to the respective surgical tool.
It is noted that, within the scope of the present invention, a first component being fixed to a second component means that there is no relative movement between the first component and the second component at their connection. It is further noted that each of the movable components of the catheter comprises a first end position (proximal end position) and a second end position (distal end position). In the first end position, a distal end of a respective component is at its furthest position with respect to the distal shaft end of the catheter shaft, whereas in the second end position the distal end of a respective component is at its closest position with respect to the distal shaft end of the catheter shaft. A respective component is movable between its corresponding first end position and its second end position. In particular, the difference between the first end position and the second end position of the first/second surgical tool corresponds to the range of motion of the first/second surgical tool, in other words the maximum distance that the first/second surgical tool may cover during its movement. Further, in particular, the first/second moving element is extracted in its second end position and retracted in its first end position.
Advantageously, the first/second moving element is/are partially arranged inside the first/second moving means receiving lumen, when the first/second moving element is/are in its/their first end position corresponding to the first end position of the first/second surgical tool. Preferably, when the first/second moving element is/are in its/their second end position corresponding to the second end position of the first/second surgical tool, the first/second moving element may be partially arranged inside the first/second moving means receiving lumen. However, when the first/second moving means comprises/comprise the first/second proximal and distal pistons, it is also possible that the first/second moving element is/are arranged completely outside the first/second moving means receiving lumen in its second end position. In other words, it can be said that the first/second moving element is preferably partially arranged inside the first/second moving means receiving lumen between its/their first end position and second end position, i.e. between the first end position and the second end position of the first/second surgical tool.
In the case of the first/second control means comprising the first/second control element being stiff as described above, the first/second control element can be, depending on the design of the catheter, partially or completely arranged in the first/second moving means receiving lumen in its/their second end position. In this case, it is noted that the first/second control element is/are arranged in the part of the first/second moving means receiving lumen that is not arranged inside the body of a patient, when the catheter is inserted in the patient’s body.
In the case of the first/second control means comprising a first/second control casing and the first/second moving element being connected to the first/second control casing by the first/second control element, the first/second control element is/are advantageously arranged at least partially, in particular completely, inside the first/second moving means lumen both in the second end position and in the first end position. It is noted that the formulation using a (slash) between two features of the catheter can be read as “and/or”. For example, the expression “the first/second moving element” can be read as “the first and/or second moving element”, which is equivalent to the expression “the first moving element and/or the second moving element”.
The present invention further refers to a method of use of the described catheter in a surgical procedure. The method comprises the step of providing a previously described catheter.
In the following, a medical balloon and a catheter with such a medical balloon are disclosed:
11. A medical balloon that is inflatable, comprising:
• a proximal balloon end,
• a distal balloon end, and
• at least one channel extending from the proximal balloon end to the distal balloon end for allowing a flow of fluid therethrough in the inflated state of the medical balloon.
12. The medical balloon of item 11 , wherein the at least one channel is formed as a recess in a circumferential area of the medical balloon.
13. The medical balloon of item 11, wherein the at least one channel extends through an inner space of the medical balloon.
14. The medical balloon of any of items 11 to I3, wherein the channel is formed such that fluid can flow substantially in one direction or only in one direction through the channel.
15. The medical balloon of any of items 11 to I4, wherein a first channel cross-section of the at least one channel is larger than a second channel cross-section of the at least one channel, in particular wherein the first channel cross-section is arranged at a first channel end, in particular a proximal channel end, and the second channel cross-section is arranged at a second channel end, in particular s distal channel end.
16. The medical balloon of item I5, wherein the at least one channel has a tapered form between the first channel cross-section and the second channel cross-section.
17. The medical balloon of any of items I4 to I6, wherein a one-way valve is arranged at the first channel cross-section or the second channel cross-section.
18. The medical balloon of any of items II to 17, wherein the at least one channel comprises two or more channels. 9. The medical balloon of any of items 11 to I8, further comprising an arranging region for arranging the medical balloon on a component of a catheter. 110. A medical balloon arrangement, comprising at least two medical balloons according to any of items 11 to I9, in particular wherein the channels of the at least two medical balloons are connected to and in fluid communication with each other by a conduit.
111. A catheter, comprising a medical balloon according to items 11 to I9 or a medical balloon arrangement of item 110.
112. The catheter of 111 , further comprising a catheter shaft and/or a tool-receiving casing arranged on the catheter shaft and configured to receive the medical balloon, wherein the medical balloon is directly arranged on the catheter shaft or on the tool-receiving tool.
The medical balloon of item 11 has the advantage that it can be fixed inside a lumen or a cavity of a patient's body when it is inflated, while still allowing fluids to be exchanged between the area proximally to the lumen or the cavity and the area distally to the lumen or the cavity. This is in particular advantageous, when the medical balloon is intended to be used in an endovascular catheter, as this would allow at least a partial blood flow in the blood vessel.
The different designs of the channel of the medical balloon of item I2 or I3 allow the medical balloon to be used in various medical applications according taking into account the anatomical characteristics of the part of a patient’s body, in which the balloon will be placed. For example, a medical balloon according to either item I2 or I3 can be used in a catheter, which is stabilized by anchoring the balloon to the wall of the oesophagus or a blood vessel of a patient. Here, the inflated balloon is inflated inside the oesophagus or the blood vessel, respectively, while allowing e.g. saliva or blood, respectively, to pass through the channel. On the other hand, a medical balloon according to item I3 might be preferred for example in a gastrointestinal catheter that needs to be prevented from being removed from the patient's body by inflating the balloon inside the stomach of a patient. Another criterion for choosing between the medical balloon according to item I2 or I3 might be the flow characteristics of a fluid inside the part of the patient's body, in which the balloon will be placed. For example, the channel of a medical balloon according to item I2 will be closer to the wall of a body lumen of the patient than the channel of a corresponding medical balloon according to item I3, when the balloon is placed inside a body lumen. The velocity of the fluid close to the wall is generally expected to be smaller than that in the middle of the body lumen. Thus, a catheter according to item of I2 might be used when there is an adequate fluid flow in the body lumen, whereas a medical balloon according to item I3 might be used when a weaker fluid flow occurs in the body lumen.
In the medical balloon of item I2, a first portion of the circumferential area of the medical balloon at a given cross-section has a larger dimension than a second portion of the circumferential area at the same cross-section. Especially when the medical balloon has two or more channels formed as recesses in its circumferential area, the medical balloon may be particularly regarded as having a main region and two or more protruding regions protruding from the main region. Here, the protruding regions are the regions of the medical balloon intended to contact the wall of a body lumen or cavity of a patient, when the balloon is in its inflated state inside the body lumen or cavity. The number of the protruding regions corresponds to the number of the recesses.
The medical balloon of item 14 is advantageous particularly in cases, in which a body fluid in a first body region being separated from a second body region by the balloon when inflated is desired or required to pass from the first body region to the second body region, while a body fluid present in the second body region should not be allowed to pass tot he first body region. For example, the first body region might comprise the oesophagus and the second body region the stomach of a patient. Saliva should be allowed to pass from the oesophagus to the stomach, when the medical balloon is anchored to the oesophagus wall, while the gastric contents should not be able to enter the oesophagus.
The selective fluid flow in only one or substantially in one direction can be achieved by the medical balloon of items 15 to 17. Furthermore, the medical balloon of item 15 or 16 may have the advantage that a fluid passing through the channel might exit through a smaller or larger crosssection that that through which the fluid entered.
Providing two or more channels in the medical balloon of item 18 has the advantage that a larger fluid volume can be passed through the channels.
The arranging region for arranging the medical balloon on a component of a catheter in the medical balloon of item 19 may extend in the direction of the longitudinal axis of a component of a catheter shaft, in particular a catheter shaft or a tool-receiving casing arranged on the catheter shaft and configured to receive the balloon.
When a catheter should comprise at least two medical balloons, using the medical balloon arrangement of item 110 has the advantage that passing of fluid from a first region of the body proximally to the first medical balloon to a second region of the body distally to the second medical balloon or from said second region to said first region is made possible.
It is noted that the medical balloon of items 11 to I9 can be used as the first surgical tool and/or the second surgical and/or the third surgical tool in a catheter according to the present invention, when any of these surgical tools is formed as an inflatable balloon . It is also possible that the medical balloon of items 11 to I9 is an independently tradable product. These and further details, advantages and features of the present invention will be described based on embodiments of the invention and by taking reference to the accompanying figures. It is shown in: figures 1 to 3 simplified schematic perspective views of a catheter with three surgical tools according to a first embodiment of the present invention, figure 4 a simplified schematic perspective view of a part of the catheter of the first embodiment, figure 5 a simplified schematic perspective view of a part of the catheter of the first embodiment, figure 6 a simplified schematic perspective view of a part of a catheter according to a second embodiment of the present invention, figures 7 to 9 simplified schematic views of an application of the catheter of the first or second embodiment, figure 10 a simplified schematic perspective view of a catheter according to a third embodiment of the present invention together with an application of said catheter, figure 11 a simplified schematic perspective view of a catheter with two surgical tools according to a fourth embodiment of the present invention, figure 12 a simplified schematic perspective view of a part of the catheter of the fourth embodiment, figure 13 a simplified schematic perspective view of a catheter with two surgical tools according to a fifth embodiment of the present invention, figure 14 a simplified schematic perspective view of a part of the catheter of the fifth embodiment, figure 15 a simplified schematic view of an application of the catheter of the fourth or fifth embodiment, figure 16 a simplified schematic view of a further application of the catheter of the fourth or fifth embodiment, figures 17 and 18 simplified schematic perspective views of a catheter with two surgical tools according to a sixth embodiment of the present invention together with an application of said catheter, figure 19 a simplified schematic perspective view of a catheter with two surgical tools according to a seventh embodiment of the present invention, figure 20 a simplified schematic perspective view of an inflatable balloon according to an example, figure 21 a simplified schematic perspective view of an inflatable balloon according to a further example, and figure 22 a simplified schematic perspective view of an inflatable balloon according to a further example.
In the following, embodiments and uses of the present invention are presented in detail by taking reference to accompanying figures 1 to 22. Identical or equivalent features and features which act identically or equivalently are denoted with the same reference signs. For the sake of conciseness, a detailed description of the elements and components is not repeated in each case of their occurrence. It is also noted that the figures are not necessarily drawn to scale.
Figures 1 to 5 show a catheter 100 according to a first embodiment of the present invention.
As can be seen from figure 1 , the catheter 100 comprises a catheter shaft 2, a first surgical tool 11 , a second surgical tool 12 and a third surgical tool 13.
The catheter shaft 2 extends along a longitudinal axis 500 from a proximal shaft end 29 to a distal shaft end 28. Further, the catheter shaft 2 comprises a main body 201 and a tip 202 attached to the main body 201.
The first surgical tool 11 and the second surgical tool 12 are movably arranged on the catheter shaft 2, while the third surgical tool 13 is fixed on the catheter shaft 2 and arranged between the first surgical tool 11 and the second surgical tool 12 in the direction of the longitudinal axis 500. In particular, the first surgical tool 11 and the second surgical tool 12 are movable on the catheter shaft 2 in the direction of the longitudinal axis 500. Thus, the first surgical tool 11 , the second surgical tool 12 and the third surgical tool 13 are movable relative to each other in the direction of the longitudinal axis 500. The first surgical tool 11 is in particular a proximal surgical tool and the second surgical tool 12 a distal surgical tool.
As shown in figures 3 and 4, for moving the first surgical tool 11 and the second surgical tool 12, the catheter 100 comprises a first moving means 31 and a second moving means 32, respectively. In particular, the first moving means 31 is formed as a first moving element 310 and the second moving means 32 as a second moving element 320. Both the first moving element 310 and the second moving element 320 are flexible and preferably formed as wires.
The first moving element 310 is connected to the first surgical tool 11 and arranged in a first moving means receiving lumen 21 defined by a catheter shaft wall 20. Accordingly, the second moving element 320 is connected to the second surgical tool 12 and arranged in a second moving means receiving lumen 22 defined by the catheter shaft wall 20. The first and second moving means receiving lumens 21 , 22 are better shown in figures 2 and 4.
Specifically, the first surgical tool 11 is fixed to/loaded on a first tool-receiving casing 61 , which is connected to the first moving element 310. In other words, the first moving element 310 is connected to the first surgical tool 11 by the first tool-receiving casing 61. The first tool-receiving casing 61 is longitudinally movably, in particular slidably, arranged on the catheter shaft 2. Thus, the tool-receiving casing 61 and the first surgical tool 11 can be moved as a unit by the first moving element 310 in the direction of the longitudinal axis 500 of the catheter shaft 2.
Accordingly, the second surgical tool 12 is fixed to/loaded on a second tool-receiving casing 62, which is connected to the second moving element 320. In other words, the second moving element 320 is connected to the second surgical tool 12 by the second tool-receiving casing 62. The second tool-receiving casing 62 is longitudinally movably, in particular slidably, arranged on the catheter shaft 2 and connected to the second moving element 320. Thus, the tool-receiving casing 62 and the second surgical tool 12 can be moved as a unit by the second moving element 320 in the direction of the longitudinal axis 500 of the catheter shaft 2.
It is, however, also possible that the first surgical tool 11 and/or the second surgical tool 12 are formed such that the first surgical tool 11 and/or the second surgical tool 12 is/are directly movably arranged on the catheter shaft 2. In this case, the first surgical tool 11 is directly connected to the first moving element 310 and/or the second surgical tool 12 is directly connected to the second moving element 320.
Referring now to figure 4, the catheter shaft 2 comprises a first distal connection opening 271 and a second distal connection opening 272. The first distal connection opening 271 and the second distal connection opening 272 are in particular formed as recesses in a circumferential area of the catheter shaft 2, through which the first moving element 310 and the second moving element 320 are connected to the first tool-receiving casing 61 and the second tool-receiving casing 62, respectively.
For controlling the movement of the first surgical tool 11 and the second surgical tool 12, the catheter 100 comprises according to figures 1 and 2 a first control means 71 and a second control means 72, respectively. In other words, the first surgical tool 11 is controllable by the first control means 71 , while the second surgical tool 12 is controllable by the second control means 72.
In particular, the first control means 71 is formed as a first control casing 710 and the second control means 72 as a second control casing 720. The first control casing 710 is particularly directly connected to the first moving element 310 and the second control casing 720 to the second moving element 320. Both the first and the second control casings 710, 720 are longitudinally movably, in particular slidably, arranged on the catheter shaft 2.
Referring back to figure 4, the catheter shaft 2 comprises a first proximal connection opening 261 and a second proximal connection opening 262. The first proximal connection opening 261 and the second proximal connection opening 262 are in particular formed as recesses in a circumferential area of the catheter shaft 2, through which the first moving element 310 and the second moving element 320 are connected to the first control casing 710 and the second control casing 720, respectively.
Due to the above described configuration, a movement of the first control casing 710 is transmittable by the first moving element 310 to the first surgical tool 11 , while a movement of the second control casing 720 is transmittable by the second moving element 320 to the second surgical tool 12.
More particularly, moving the first control casing 710 in a direction from the proximal shaft end 29 to the distal shaft end 28 causes a movement of the first surgical too! 11 in the same direction. Accordingly, moving the second control casing 720 in the direction from the proximal shaft end 29 to the distal shaft end 28 causes a movement of the second surgical tool 12 in the same direction.
To this end, the first moving element 310 is arranged in the first moving means receiving lumen 21 in such a way that the first moving element 310 is at least partially circumferentially supported by the catheter shaft wall 20 so that the first surgical tool 11 is movable by the first moving element 310 in the direction from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2. Accordingly, the second moving element 320 is arranged in the second moving means receiving lumen 22 in such a way that the second moving element 320 is at least partially circumferentially supported by the catheter shaft wall 20 so that the second surgical tool 12 is movable by the second moving element 320 in the direction from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2
Thus, the at least partial circumferential support of the first moving element 310 and the second moving element 320 by the catheter shaft wall 20 enables them, even if they are formed as flexible moving elements, to cause a movement of the first surgical tool 11 and the second surgical tool 12, respectively.
As can be seen in particular from figure 5, the first moving means receiving lumen 21 and the first moving element 310 have the same shape and are each formed in particular as a circular cylinder. For achieving the at least partial circumferential support of the first moving element 310, it is preferred that the first moving element 310 has a diameter (outer diameter) that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the first moving means receiving lumen 21. It is noted that figure 5 shows only a part of the catheter shaft wall 20 needed to define and graphically represent the first moving means receiving lumen 21 .
Preferably, the same configuration also applies to the second moving means receiving lumen 22 and the second moving element 320. That is, the second moving means receiving lumen 22 and the second moving element 320 have the same shape and are each formed in particular as a circular cylinder. For achieving the at least partial circumferential support of the second moving element 320, it is preferred that the second flexible moving element 320 has a diameter (outer diameter) that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the second moving means receiving lumen 22.
In this embodiment, all surgical tools 11 , 12, 13 are formed as inflatable balloons. In other words, the first surgical tool 11 is formed as a first inflatable balloon, the second surgical tool 12 as a second inflatable balloon and the third surgical tool 13 as a third inflatable balloon.
For inflating the first inflatable balloon, the first moving element 310 is hollow and in fluid communication with the first inflatable balloon. Thus, inflating fluid can flow into the first moving element 310 (denoted by arrow 311 in figure 5) and exit through it (denoted by arrow 312 in figure 5) in order to be delivered to the first inflatable balloon. To this end, the first tool-receiving casing 61 and the first control casing 710 are each provided with a respective opening in order to enable the flow of the inflating fluid into and out of the first moving element 310.
Accordingly, for inflating the second inflatable balloon, the second moving element 320 is hollow and in fluid communication with the second inflatable balloon. Thus, inflating fluid can flow into the second moving element 320 and exit through it in order to reach the second inflatable balloon. To this end, the second tool-receiving casing 62 and the second control casing 720 are each provided with a respective opening in order to enable the flow of the inflating fluid into and out of the second moving element 320. For inflating the third inflatable balloon, the catheter shaft 2 comprises an inflating fluid passing lumen 23. The inflating fluid passing lumen 23 communicates with the third inflatable balloon through an inflating fluid passing opening 230 formed in a circumferential area of the catheter shaft 2. As can be seen from figure 2, the inflating fluid passing lumen 23 advantageously extends from the proximal shaft end 29 to the position of the third inflatable balloon.
Further, the catheter shaft 2 comprises a further lumen 24. The further lumen 24 can be used for receiving a guidewire 200 and/or for passing fluid, for example body fluids, therethrough. The further lumen 24 advantageously extends from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2.
Contrary to the further lumen 24 and the inflating fluid passing lumen 23, which extend as described from the proximal shaft end 29 of the catheter shaft 2, it becomes apparent from figure 2 that a respective proximal end of the first moving means receiving lumen 21 and the second moving means receiving lumen 22 is spaced apart from the proximal shaft end 29. It is noted that figure 3 schematically represents a part of the catheter 100 of figure 2 that extends from the distal shaft end 28 to an area of the catheter shaft 2 between the first distal connection opening 271 and the second proximal connection opening 262. That is why in figure 3 all four lumens 21 , 22, 23 and 24 are shown.
Figure 6 refers to a catheter 100 according to a second embodiment of the present invention.
The catheter 100 according to the second embodiment differs from the catheter 100 according to the first embodiment in the configuration of the first moving means 31 and the first controls means 71 as well as that of the second moving means 32 and the second control means 72 for moving and controlling the first surgical tool 11 and the second surgical tool 12, respectively. Preferably, the first moving means 31 and the second moving means 32, and the first control means 71 and the second control means 72 comprise same components, respectively, so that figure 6 refers to the components of said means with regard to both the first surgical tool 11 and the second surgical tool 12. It is noted that figure 6 shows only a part of the catheter shaft wall 20 needed to define and graphically represent the first moving means receiving lumen 21 or the second moving means receiving lumen 22.
The first moving means 31 in the catheter 100 of the second embodiment comprises apart from the first moving element 310 a first distal piston 81 and a first proximal piston 91. The first distal piston 81 and the first proximal piston 91 are arranged in the first moving means receiving lumen 21 . A first space 111 between the first distal piston 81 and the first proximal piston 91 is filled with an incompressible fluid. It can be seen from figure 6 that the first moving element 310 is connected to the first distal piston 81. Due to the at least partial circumferential support of the first moving element 310 as described above with respect to the catheter 100 of the first embodiment and the incompressible fluid in the first space 111 between the first distal piston 81 and the first proximal piston 91 , a movement of the first proximal piston 91 in the direction from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2 causes a movement of the first surgical tool 11 in the same direction. A movement of the first proximal piston 91 in the opposite direction, in other words the direction from the distal shaft end 28 to the proximal shaft end 29 of the catheter shaft 2, causes due to the build-up of negative pressure in the first space 111 the first distal piston 81 and thus also the first surgical tool 11 to be moved in the direction from the distal shaft end 28 to the proximal shaft end 29. Here, the first surgical tool 11 is pulled by the first moving element 310 towards the proximal shaft end 29.
In order to control the movement of the first proximal piston 91 and consequently that of the first surgical tool 11 , the first control means 71 comprises apart from the first control casing 710 a first control element 711. The first control element 711 can be formed as a stiff control element connected to or formed integrally with the first proximal piston 91.
Alternatively, the first control element 711 can be formed as a flexible control element connected to the first proximal piston 91. Here, the first control element 711 is preferably arranged in the first moving means receiving lumen 21 in such a way that the first control element 711 is at least partially circumferentially supported by the catheter shaft wall 20 so that the first proximal piston 91 is movable towards the distal shaft end 28 of the catheter shaft 2 by the first control element 711. In particular, the first control element 711 can be formed like the first moving element 310.
In order to deliver inflating fluid to the first surgical tool 11 being an inflatable balloon (first inflatable balloon), in addition to the first moving element 310 being hollow, the first distal piston 81 , the first proximal piston 91 and the first control element 711 are also hollow. Further, a first conduit 121 is arranged between the first distal piston 81 and the first proximal piston 91 and establishes fluid communication between the first moving element 310 and the first control element 711.
Accordingly, the second moving means 32 in the catheter 100 of the second embodiment comprises apart from the second moving element 320 a second distal piston 82 and a second proximal piston 92. The second distal piston 82 and the second proximal piston 92 are arranged in the second moving means receiving lumen 22. A second space 112 between the second distal piston 82 and the second proximal piston 92 is filled with an incompressible fluid. The second moving element 320 is connected to the second distal piston 82. Due to the at least partial circumferential support of the second moving element 320 as described above with respect to the catheter 100 of the second embodiment and the incompressible fluid in the second space 112 between the second distal piston 82 and the second proximal piston 92, a movement of the second proximal piston 92 in the direction from the proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2 causes a movement of the second surgical tool 11 in the same direction. A movement of the second proximal piston 92 in the opposite direction, in other words the direction from the distal shaft end 28 to the proximal shaft end 29 of the catheter shaft 2, causes due to the build-up of negative pressure in the second space 112 the second distal piston 82 and thus also the second surgical tool 12 to be moved in the direction from the distal shaft end 28 to the proximal shaft end 29. Here, the second surgical tool 12 is pulled by the second moving element 320 towards the proximal shaft end 29.
In order to control the movement of the second proximal piston 92 and consequently that of the second surgical tool 12, the second control means 72 comprises apart from the second control casing 720 a second control element 721. The second control element 721 can be formed as a stiff control element connected to or formed integrally with the second proximal piston 92.
Alternatively, the second control element 721 can be formed as a flexible control element connected to the second proximal piston 92. Here, the second control element 721 is preferably arranged in the second moving means receiving lumen 22 in such a way that the second control element 721 is at least partially circumferentially supported by the catheter shaft wall 20 so that the second proximal piston 92 is movable towards the distal shaft end 28 of the catheter shaft 2 by the second control element 721. In particular, the second control element 721 can be formed like the second moving element 320.
In order to deliver inflating fluid to the second surgical tool 12 being an inflatable balloon (second inflatable balloon), in addition to the second moving element 320 being hollow, the second distal piston 82 and the second proximal piston 92 are also hollow. In addition, the second control element 721 is provided with a respective opening so that fluid communication can be established between the second control element 721 and the second control element 720. Further, a second conduit 112 is arranged between the second distal piston 82 and the second proximal piston 92 and establishes fluid communication between the second moving element 320 and the second control element 721.
Though the first moving means 31 and the second moving means 32 of the catheter 100 of the first embodiment or the second embodiment comprise same components, respectively, it is also possible that the first moving means 31 of a catheter 100 according to the present invention is formed like the first moving means 31 of the catheter 100 of the first embodiment and the second moving means 32 like the second moving means 32 of the catheter 100 of the second embodiment or vice versa. The same applies also to the first control means 71 and the second control means 72.
Figures 7 to 9 show an advantageous application, in which the catheter 100 of the first or the second embodiment of the present invention can be used.
In figures 7 to 9, the catheter 100 is shown inside a blood vessel 900, in particular the descending aorta, in different states. In figure 7, the first inflatable balloon corresponding to the first surgical tool 11 and the second inflatable balloon corresponding to the second surgical tool 12 are placed at their closest position to the third inflatable balloon corresponding to the third surgical tool 13. It is reminded that the first inflatable balloon and the second inflatable balloon are movably arranged on the catheter shaft 2 of the catheter 100, whereas the third inflatable balloon is fixed on the catheter shaft 2.
In the state of the catheter 100 shown in figure 7, all inflatable balloons are deflated.
In the state of the catheter 100 shown in figure 8, all inflatable balloons are inflated, while the first inflatable balloon and the second inflatable balloon have been moved away from the third inflatable balloon. The first inflatable balloon can be characterised as a proximal balloon, the second inflatable balloon as a distal balloon and the third inflatable balloon as a middle balloon.
In the state of the catheter 100 shown in figure 9, the first inflatable balloon and the second inflatable balloon are at their furthest position from the third inflatable balloon, while they are still inflated.
By appropriately combining a movement of the first and second inflatable balloons relative to each other and to the third inflatable balloon in their inflated or deflated state, the catheter 100 can be used as a blood pump, in particular an intra-aortic balloon pump.
To this end, the doctor first inserts the catheter 100 into the patient’s body, for example through the femoral artery, and forwards the catheter 100 until it reaches the ascending aorta. This is done with all inflatable balloons being deflated (figure 7). At the beginning of or just prior to the next diastolic phase of the heart, the doctor inflates all the inflatable balloons and starts moving the first and second, now inflated, balloons away from each other and from the third, now inflated, balloon (figures 8 and 9). Thus, blood that already exists in the ascending aorta due to the previous systolic phase of the heart is being pumped by the first inflated balloon towards the legs of the patient and by the second inflated balloon towards the heart and the head of the patient. In other words, the first inflated balloon and the second inflated balloon act as pistons that push blood to the periphery of the patient’s body. When the next systolic phase of the heart begins or just prior to that, the doctor deflates all the balloons and starts moving the first and second, now deflated, balloons towards the third, now deflated, balloon, in order to prepare for the next diastolic phase of the heart. As al! the inflatable balloons are deflated during the systolic phase of the heart, blood being pumped by the heart can pass by the catheter 100.
Due to the provision of two movable inflatable balloons, namely the first and the second inflatable balloons, in the catheter 00, a cardiac output can greatly be increased, while more parts of the human body can be supplied with blood at the same time. The movement of the first and second inflatable balloons is mechanically supported due to the fixed arrangement of the third inflatable balloon on the catheter shaft 2.
Figure 10 shows a catheter 100 according to a third embodiment of the present invention together with an advantageous application of said catheter 100.
The catheter 100 according to the third embodiment differs from the catheter 100 according to the first or the second embodiment in that the catheter 100 comprises a plurality of body fluid bypass openings formed in a circumferential area of the catheter shaft 2 proximally to the first inflatable balloon corresponding to the first surgical tool 11. The body fluid bypass openings are in fluid communication with the further lumen 24.
The catheter 100 according to the third embodiment can advantageously be used for the treatment of an abdominal aortic aneurysm.
An abdominal aortic aneurysm is a localized enlargement of the abdominal aorta such that the diameter is usually greater than 3 cm or more than 50% larger than normal. An abdominal aortic aneurysm usually causes no symptoms, except during rupture. In 70% to 80% of the patients with an abdominal aortic aneurysm, the vessel wall of the abdominal aortic aneurysm is covered by an intraluminal thrombus, which generally does not preclude blood flow. It is generally accepted that the sooner a patient with a ruptured abdominal aortic aneurysm is operated, the more chances the patient has to survive, as the massive haemorrhage from the rupture of the abdominal aortic aneurysm results in a massive internal bleeding and blood loss that usually leads to the death of the patient. On the other hand, a surgical treatment of the abdominal aortic aneurysm rupture carries a high morbidity and mortality rate, since such a procedure most of the times takes place only many hours after diagnosis, as not all medical centres are capable of performing such surgical procedures and therefore the patient has to be first transferred to a specialised hospital. Thus, for the most successful outcome, an early diagnosis and a prompt treatment of the abdominal aortic aneurysm rupture are essential. As soon as a rupture of the abdominal aortic aneurysm has occurred, death is inevitable unless the bleeding can be stopped and blood flow to the lower body can be promptly restored within the first few hours after the diagnosis.
The catheter 100 according to the third embodiment has the great advantage that it can be used by any endovascular surgeon in any medical centre with an angiography suite and immediately stabilizes the patient by stopping the blood loss and restoring blood perfusion to lower limbs and internal organs.
Referring back to figure 10, the blood vessel 900 shown therein the abdominal aorta of a patient. As can further be seen, an abdominal aortic aneurysm 903 is covered by an intraluminal thrombus 902 and has a rupture 901.
In order to treat the abdominal aortic aneurysm, the surgeon needs to insert the catheter 100 of the present embodiment into the abdominal aorta, position the first inflatable balloon 11 and the second inflatable balloon 12 at a distal end and a proximal end of the aneurysm 903, respectively, and inflate them, so that the area of the blood vessels 900 comprising the aneurysm 903 is isolated and blood loss through the rupture 901 can be prevented. The third inflatable balloon being arranged between the first and the second inflatable balloons is also inflated in order to better stabilize the catheter 100 inside the aneurysm 903. However, it is also possible that the catheter 100 does not comprise the third inflatable balloon.
Blood flowing in an area proximally to the aneurysm 903 may enter the further lumen 24 (denoted by arrow 904) and exit the further lumen 24 in an area distally to the aneurysm 903 through the plurality of body fluid bypass openings 280 (denoted by the plurality of arrows 905). Thus, blood flow is not or at least not completely obstructed during treatment of the abdominal aortic aneurysm 903. In particular, the body fluid bypass openings 280 can be arranged on the catheter shaft 2 in such a way, that blood can be directed to different parts of the patient’s body.
Figures 11 and 12 refer to a catheter 100 according to a fourth embodiment of the present invention.
The catheter 100 according to the fourth embodiment differs from the catheter 100 according to the first or second embodiment in that the catheter 100 according to the fourth embodiment comprises only the first surgical tool 11 and the second surgical tool 12 being formed as inflatable balloons.
In other words, the third surgical tool 13 being an inflatable balloon in the catheter 100 of the first or the second embodiment is here omitted. Due to this, also the inflating fluid passing opening 230 and the corresponding inflating fluid passing lumen 23 are omitted. It is noted that the first moving means 31 , second moving means 32, first control means 71 and second control means 72 can be formed as the ones of the catheter 100 of the first or the second embodiment.
A further difference between the catheter 100 of the fourth embodiment and that of the first or second embodiment lies in that the catheter 100 of the fourth embodiment comprises two further lumens 24.
The first further lumen 24 preferably communicates with a fluid delivering opening 290 formed in a circumferential area of the catheter shaft 2 between the first surgical tool 11 and the second surgical tool 12. Thus, the first further lumen 24 is used as a fluid passing lumen. Therefore, the first further lumen 24 preferably extends from the proximal shaft end 29 to the position of the fluid delivering opening 290. Through the fluid delivering opening 290, a fluid can be delivered to an area of a body lumen isolated by the first and second inflatable balloons.
The second further lumen 24 can be used for receiving a guidewire 200 as well as passing fluid therethrough, when the guidewire 200 is removed. In other words, the second further lumen 24 can be characterised as a guidewire receiving and fluid passing lumen 24. Therefore, the second further lumen 24 preferably extends from a proximal shaft end 29 to the distal shaft end 28 of the catheter shaft 2. In particular, the second further lumen 24 can be used for passing body fluids therethrough.
Figures 13 and 14 refer to a catheter 100 according to a fifth embodiment of the present invention.
The catheter 100 according to the fifth embodiment differs from that of the first or second embodiment in that the catheter 100 according to the fifth embodiment comprises only one movable surgical tool formed as an inflatable balloon, namely the first surgical tool 11 .
Contrary to the catheter 100 of the first or second embodiment, the second surgical tool 12 of the catheter 100 in the present embodiment is fixed on the catheter shaft 2. The second surgical tool 12 is also here formed as an inflatable balloon. In particular, the second surgical tool 12 of the catheter 100 of the present embodiment corresponds to the third surgical tool 13 of the catheter 100 according to the first or second embodiment.
The catheter 100 of the fourth or the fifth embodiment can be used in an angiography procedure explained based on figure 15.
During an angiography procedure, a contrast agent is delivered inside the blood vessel 900 through the first further lumen 24 and the fluid delivering opening 290 (denoted by arrows 907). In order to avoid that the contrast agent is washed away by the blood flow in the blood vessel 900 and thus achieve that the contrast agent is targeted at the region of interest, for example the smaller blood vessels 906 communicating with the blood vessel 900, the first inflatable balloon and the second inflatable balloon are inflated. This results in the isolation of the region of interest from the rest of the blood vessel 900. Thereby, the maximum possible concentration of the contrast agent in the isolated region of interest can be achieved.
At the same time, blood flow in the blood vessel 900 is not obstructed, as blood can flow through the second further lumen 24.
It is noted that the second further lumen 24 can be omitted from the catheter 100 according to the fourth or fifth embodiment, as an angiography procedure does not last long and thus it is not crucial to maintain blood flow in the blood vessel 900 during the procedure.
The catheter 100 of the fourth or the fifth embodiment can also be used in a thrombolytic procedure explained based on figure 16.
An area of the blood vessel 900, in which an intraluminal thrombus 902 has been built up, can be isolated by inflating the first inflatable balloon and the second inflatable balloon.
Thus, a thrombolytic fluid can directly be delivered to the intraluminal thrombus 902 through the fluid delivering opening 290 communicating with the first further lumen 24 without being washed away by the blood flow in the blood vessel 900. Thereby, the maximum possible concentration of the thrombolytic fluid in the isolated region of interest can be achieved. An additional advantage of isolating the area of the blood vessel 900, in which the intraluminal thrombus 902 is formed, is that the smaller pieces, into which the thrombus 902 is split after the initial effect of the thrombolytic fluid, can remain between the inflated balloons at first. Thus, they can be further reduced in size so that they do not pose a threat for the patient when they return to the normal blood circulation.
In order to deliver thrombolytic fluid to multiple areas of the intraluminal thrombus 902 at the same time, a plurality of fluid delivering openings 290 can be provided in the circumferential area of the catheter shaft 2, as shown in figure 16.
Furthermore, blood flow in the blood vessel 900 is not obstructed, as blood can flow through the second further lumen 24. In addition, body fluid bypass openings 280 can be provided in the circumferential area of the catheter shaft 2 proximally to the first inflatable balloon in order to obtain a more targeted delivery of blood in the blood vessel 900.
In figures 17 and 18, a catheter 100 according to a sixth embodiment of the present invention together with an advantageous application of the catheter 100 is presented. A first difference between the catheter 100 according to the sixth embodiment and that of the fourth embodiment is that the first surgical too! 11 in the catheter 100 according to the sixth embodiment is not an inflatable balloon but a stabilizing tool. The first surgical tool 11 is a proximal surgical tool.
A second difference lies in that the catheter 100 according to the sixth embodiment comprises only one further lumen 24 that preferably extends from the proximal shaft end 29 to the distal shaft end 28. In particular, the further lumen 24 corresponds to the second further lumen 24 of the catheter 100 of the fourth embodiment. Further, the fluid delivering opening 290 and the corresponding further lumen 24 provided in the catheter 100 of the fourth embodiment are omitted in the catheter 100 of the present embodiment.
As can be seen from figures 17 and 18, the catheter 100 of the present embodiment can be used in a gastrostomy, which is a surgical procedure used for providing a route for tube feeding if needed for four weeks or longer, and/or to vent the stomach for air or drainage.
More specifically, said route for tube feeding can be provided by the catheter 100 of the present embodiment and in particular from the above-described further lumen 24.
To this end, the surgeon first inserts the catheter 100 through the abdomen 908 and the stomach 909, until the inflatable balloon corresponding to the second surgical tool 12 (distal surgical tool) is positioned inside the stomach 909. During this step, the inflatable balloon is in its deflated state.
Then, the balloon is inflated and the first control casing 710 and the second control casing 720 controlling the movement of the stabilising tool and the balloon, respectively, are manipulated such that the abdomen 908 and the stomach 909 are pressed tightly against each other.
By keeping the first control casing 710 and the second control casing 720 stable and moving the catheter shaft 2 forward, i.e. towards the inner lumen of the stomach 909, the catheter shaft 2, in particular its distal shaft end 28, can be positioned at the region of interest inside the stomach 901. At the same time, the abdomen 908 and the stomach 909 can maintain their position relative to each other.
In particular, food can be provided through the further lumen 24 to the stomach.
Figure 19 shows a catheter 100 according to a seventh embodiment of the present invention.
The catheter 100 according to the seventh embodiment differs from the catheter 100 according to the fourth embodiment in that the second surgical tool 12 of the catheter 100 of the seventh embodiment is not an inflatable balloon but a cutting device. In particular, the cutting device is formed as an atherectomy blade used for cutting away an atheroma in a blood vessel. For this purpose, the doctor inserts the catheter 100 in the blood vessel, while the inflatable balloon corresponding to the first surgical tool 11 is in its deflated state.
When the catheter shaft 2 has reached the atheroma, the doctor inflates the inflatable balloon, thereby anchoring it to the wall of the blood vessel. Then, the catheter shaft 2 is pushed towards the atheroma. The force, with which the catheter shaft 2 is pushed, is transferred close to the tip 202 of the catheter shaft 2 and therefore also to the atherectomy blade being fixed to the catheter shaft 2 close to the tip 202.
Thus, the atheroma can easily be cut away from the blood vessel.
Figure 20 shows an inflatable balloon (medical balloon) 1000 directly arranged on a catheter shaft 2. That is, the inflatable balloon 1000 is not fixed to a tool-receiving casing being longitudinally movably arranged on the catheter shaft 2, but is itself longitudinally movably arranged on the catheter shaft 2. The inflatable balloon 1000 advantageously has a form that completely surrounds the catheter shaft 2. In particular, the inflatable balloon is barrel-shaped. However, the inflatable balloon 1000 can also have other forms, e.g. be formed as donut or a hollow cylinder.
The first inflatable balloon corresponding to the first surgical tool 11 and/or the second inflatable balloon corresponding to the second surgical tool 12 of the previously described embodiments can also be directly arranged on the catheter shaft 2 in a movable manner like the balloon 1000 of figure 20. In this case, the first moving element 310 and/or the second moving element 320 is/are directly connected to the first inflatable balloon and/or the second inflatable balloon via the first distal connection opening 271 and/or the second distal connection opening 272, respectively.
Figure 21 shows another example of an inflatable balloon (medical balloon) 1000.
The inflatable balloon 1000 comprises two channels 1003 that extend from a proximal balloon end 1001 to a distal balloon end 1002 for allowing a flow of fluid therethrough in its inflated state.
In particular, the channels 1003 are formed as recesses in a circumferential area of the balloon 1000.
The channels 1003 are formed such that fluid can flow substantially in one direction or only in one direction through each channel 1003.
To this end, a first channel cross-section (cross-sectional area) at a first channel end 1006 of each channel 1003 is larger than a second channel cross-section (cross-sectional area) at a second channel end 100/ ot the corresponding channel 1003. As can be seen from figure 21 , the first channel end 1006 corresponds to a proximal channel end and the second channel end 1007 response to a distal channel end.
Thus, each channel 1003 has a tapered form between the first channel cross-section and the second channel cross-section, in other words between the proximal channel end and the distal channel end.
The inflatable balloon 1000 further comprises an arranging region 1005 for arranging the medical balloon the component of the catheter. The component can be a tool-receiving casing arranged on a catheter shaft of the catheter or the catheter shaft itself.
Figure 22 shows another example of an inflatable balloon (medical balloon) 1000.
The difference between the balloon 1000 of figure 22 and that of figure 21 is that the channels 1003 of the balloon 1000 of the present example are not formed as recesses in the circumferential area of the balloon 1000, but extend through an inner space of the balloon 1000.
One of the channels 1003 has a tapered formed between the first channel cross-section and the second channel cross-section, in other words between the proximal channel end and the distal channel end. Thus, fluid can flow, depending on the ratio of the first cross-section to the second cross-section, substantially or only in the direction from the proximal channel end to the distal channel end of the channel 1003.
The other channel 1003 has a cylindrical form, but is provided with a one-way valve 1008 at its distal channel end. The one-way valve can be formed for example as a flap. Thus, fluid can flow only in the direction from the proximal channel end to the distal channel end of the channel 1003.
It is noted that the first inflatable balloon corresponding to the first surgical tool 11 and/or the second inflatable balloon corresponding to the second surgical tool 12 and/or the third inflatable balloon corresponding to the third surgical tool 13 of the previously described embodiments can be formed as the balloon 1000 of figures 21 and 22.
The depicted and described features and further properties of the invention's embodiments can arbitrarily be isolated and recombined without leaving the gist of the present invention.
In addition to the foregoing description of the present invention, for an additional disclosure explicit reference is taken to graphic representation of figures 1 to 22. Reference signs list
2 catheter shaft
20 catheter shaft wall
21 first moving means receiving lumen
22 second moving means receiving lumen
23 inflating fluid passing lumen
24 further lumen
28 distal shaft end
29 proximal shaft end
31 first moving means
32 second moving means
61 first tool-receiving casing
62 second tool-receiving casing
71 first control means
72 second control means
81 first distal piston
82 second distal piston
91 first proximal piston
92 second proximal piston
100 catheter
111 first space
112 second space
121 first conduit
122 second conduit
200 guidewire
201 main body
202 tip
230 inflating fluid passing opening
261 first proximal connection opening
262 second proximal connection opening
271 first distal connection opening
272 second distal connection opening
280 body fluid bypass opening
290 fluid delivering opening 310 first moving element
311 arrow
312 arrow
320 second moving element
500 longitudinal axis
710 first control casing
711 first control element
720 second control casing
721 second control element
900 blood vessel
901 rapture
902 intraluminal thrombus
903 abdominal aortic aneurysm
904 arrow
905 arrow
906 blood vessel
907 arrow
908 abdomen
909 stomach
1000 inflatable balloon
1001 proximal balloon end
1002 distal balloon end
1003 channel
1004 inner space
1005 arranging region
1006 first channel end
1007 second channel end
1008 one-way valve

Claims

Claims
1. A catheter (100), comprising:
• a catheter shaft (2) that extends along a longitudinal axis (500),
• a first surgical tool (11),
• a second surgical tool (12), and
• a first moving means (31),
• wherein the first surgical tool (11) and the second surgical tool (12) are movable relative to each other in the direction of the longitudinal axis (500), wherein the first surgical tool (11 ) is movable on the catheter shaft (2) in the direction of the longitudinal axis (500) by the first moving means (31), and wherein the second surgical tool (12) is movable on the catheter shaft (2) in the direction of the longitudinal axis (500) by a second moving means (32) or wherein the second surgical tool (12) is fixed on the catheter shaft (2).
2. The catheter (100) of claim 1 , wherein the catheter (100) further comprises a third surgical tool (13) that is fixed on the catheter shaft (2).
3. The catheter (100) according to claim 2, wherein the third surgical tool (13) is arranged between the first surgical tool (11) and the second surgical tool (12).
4. The catheter (100) according to any of the preceding claims, wherein a respective surgical tool (11 , 12, 13) is formed as an inflatable balloon or a cutting device or a stabilizing tool.
5. The catheter (100) of any of claims 2 to 4, wherein the third surgical tool (13) is formed as an inflatable balloon and the catheter shaft (2) comprises an inflating fluid passing lumen (23) that communicates with the inflatable balloon through an inflating fluid passing opening (230) formed in a circumferential area of the catheter shaft (2).
6. The catheter (100) of any of the preceding claims, wherein: the first moving means (31) comprises a first moving element (310), wherein the first moving element (310) is flexible, connected to the first surgical tool (11) and arranged in a first moving means receiving lumen (21 ) defined by a catheter shaft wall (20), wherein the first moving element (310) is arranged in the first moving means receiving lumen (21 ) in such a way that the first moving element (310) is at least partially circumferentially supported by the catheter shaft wall (20) so that the first surgical tool (11) 40 is movable by the first moving element (310) in a direction from a proximal shaft end (29) of the catheter shaft (2) to a distal shaft end (28) of the catheter shaft (2), in particular wherein the first surgical tool (11) is formed as a first inflatable balloon and the first moving element (310) is hollow and in fluid communication with the first inflatable balloon, and/or wherein: the second surgical tool (12) is movable on the catheter shaft (2) in the direction of the longitudinal axis (500) by the second moving means (32) and the second moving means (32) comprises a second moving element (320), wherein the second moving element (320) is flexible, connected to the second surgical tool (12) and arranged in a second moving means receiving lumen (22) defined by a catheter shaft wall (20), wherein the second moving element (320) is arranged in the second moving means receiving lumen (22) in such a way that the second moving element (320) is at least partially circumferentially supported by the catheter shaft wall (20) so that the second surgical tool (12) is movable by the second moving element (320) in a direction from a proximal shaft end (29) of the catheter shaft (2) to a distal shaft end (28) of the catheter shaft (2), in particular wherein the second surgical tool (12) is formed as a second inflatable balloon and the second moving element (320) is hollow and in fluid communication with the second inflatable balloon. The catheter (100) of claim 6, wherein the first surgical tool (11) is controllable by a first control means (71) that is connected to the first moving element (310), wherein in particular the first control means (71) comprises a first control casing (710) that is longitudinally movably, in particular slidably, arranged on the catheter shaft (2) and connected to the first moving element (310), wherein the first moving element (310) is connected directly to the first control casing (710) or wherein the first control means (71) comprises a first control element (711) by which the first moving element (310) is connected to the first control casing (710) and which is formed as a stiff control element, and/or wherein the second surgical tool (12) is controllable by a second control means (72) that is connected to the second moving element (320), wherein in particular the second control means (72) comprises a second control casing (720) that is longitudinally movably, in 41 particular slidably, arranged on the catheter shaft (2) and connected to the second moving element (320), wherein the second moving element (320) is connected directly to the second control casing (720) or wherein the second control means (72) comprises a second control element (721) by which the second moving element (320) is connected to second control casing (720) and which is a formed as a stiff control element. The catheter (100) of claim 6, wherein: the first moving means (31 ) further comprises a first distal piston (81 ) and a first proximal piston (91), wherein the first distal piston (81) and the first proximal piston (91) are arranged in the first moving means receiving lumen (21) and a first space (111 ) between the first distal piston
(81) and the first proximal piston (91) is filled with an incompressible fluid, and wherein the first moving element (310) is further connected to the first distal piston (81 ), wherein the first moving element (310) is arranged in the first moving means receiving lumen (21) in such a way that the first moving element (310) is at least partially circumferentially supported by the catheter shaft wall (20) so that a movement of the first proximal piston (91) in a direction from the proximal shaft end (29) of the catheter shaft (2) to the distal shaft end (28) of the catheter shaft (2) causes a movement of the first surgical tool (11), in particular wherein the first distal piston (81) and the first proximal piston (91) are hollow and wherein the first moving element (310) is further in fluid communication with a first conduit (121 ) that is arranged between the first distal piston (81) and the first proximal piston (91), and/or wherein: the second moving means (32) further comprises a second distal piston (82) and a second proximal piston (92), wherein the second distal piston (82) and the second proximal piston (92) are arranged in the second moving means receiving lumen (22) and a second space (112) between the second distal piston (82) and the second proximal piston (92) is filled with an incompressible fluid, wherein the second moving element (320) is further connected to the second distal piston
(82), wherein the second moving element (320) is arranged in the second moving means receiving lumen (22) in such a way that the second moving element (320) is at least partially circumferentially supported by the catheter shaft wall (20) so that a movement of the second proximal piston (92) in the direction from the proximal shaft end (29) of the catheter shaft (2) to the distal shaft end (28) of the catheter shaft (2) causes a movement of the second surgical tool (12), in particular wherein the second distal piston (82) and the second proximal piston (92) are hollow and wherein the second moving element (320) is further in fluid communication with a second conduit that is arranged between the second distal piston (82) and the second proximal piston (92). The catheter (100) of claim 8, wherein: the first surgical tool (11) is controllable by a first control means (71) connected to the first proximal piston (91), wherein the first control means (71) comprises a first control element (711 ) that is formed as a stiff control element connected to or formed integrally with the first proximal piston (91) or that is formed as a flexible control element connected to the first proximal piston (91) and arranged in such a way that the first control element (711) is at least partially circumferentially supported by the catheter shaft wall (20) so that the first proximal piston (91) is movable towards the distal shaft end (28) of the catheter shaft (2) by the first control element (711), in particular wherein the first control means (71) further comprises a first control casing (7 0) that is longitudinally movably, in particular slidably, arranged on the catheter shaft (2) and connected to first control element (711), and/or wherein: the second surgical tool (12) is controllable by a second control means (72) connected to the second proximal piston (92), wherein the second control means (72) comprises a second control element (721 ) that is formed as a stiff control element connected to or formed integrally with the second proximal piston (92) or that is formed as a flexible control element connected to the second proximal piston (92) and arranged in such a way that the second control element (721 ) is at least partially circumferentially supported by the catheter shaft wall (20) so that the second proximal piston (92) is movable towards the distal shaft end (28) of the catheter shaft (2) by the second control element (721), in particular wherein the second control means (72) further comprises a second control casing (720) that is longitudinally movably, in particular slidably, arranged on the catheter shaft (2) and connected to second control element (721). The catheter (100) of any of claims 6 to 9, wherein: at least the first flexible moving element portion that is movably arranged in the first moving means receiving lumen (21) between a first end position and a second end position of the first flexible moving element (310) has a cross-sectional area over at least a part of its whole length that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a cross-sectional area of the first moving means receiving lumen (21), and/or at least the first flexible moving element portion that is movably arranged in the first moving means receiving lumen (21) between a first end position and a second end position of the first flexible moving element (310) has over at least a part of its whole length the same shape with the first moving means receiving lumen (21), in particular wherein at least said first flexible moving element portion and the first moving means receiving lumen (21) are formed as circular cylinders, in particular wherein at least said first flexible moving element portion has over at least a part of its whole length a diameter that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the first moving means receiving lumen (21 ), and/or the first flexible moving element (310) is arranged in the first moving means receiving lumen (21) in such a way that the first flexible moving element portion that is movably arranged in the first moving means receiving lumen (21) between a first end position and a second end position of the flexible moving element (310) has over at least a part of its whole length a shape that is complementary to a shape of the first moving means receiving lumen (21 ); and/or wherein: 44 at least the second flexible moving element portion that is movably arranged in the second moving means receiving lumen (22) between a first end position and a second end position of the second flexible moving element (320) has a cross-sectional area over at least a part of its whole length that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a cross-sectional area of the second moving means receiving lumen (22), and/or at least the second flexible moving element portion that is movably arranged in the second moving means receiving lumen (22) between a first end position and a second end position of the second flexible moving element (320) has over at least a part of its whole length the same shape with the second moving means receiving lumen (22), in particular wherein at least said second flexible moving element portion and the second moving means receiving lumen (22) are formed as circular cylinders, in particular wherein at least said second flexible moving element portion has over at least a part of its whole length a diameter that is at least 80%, more preferably at least 85%, even more preferably at least 90%, even more preferably at least 95%, most preferably substantially 100%, of a diameter of the second moving means receiving lumen (22), and/or the second flexible moving element (320) is arranged in the second moving means receiving lumen (22) in such a way that the second flexible moving element portion that is movably arranged in the second moving means receiving lumen (22) between a first end position and a second end position of the flexible moving element (320) has over at least a part of its whole length a shape that is complementary to a shape of the second moving means receiving lumen (22). The catheter (100) of any of claims 6 to 10, wherein the first surgical tool (11) is connected directly to the first moving element (310) and directly arranged on the catheter shaft (2), or wherein the first surgical tool (11) is arranged on, in particular fixed to, a first tool-receiving casing (61) that is longitudinally movably, in particular slidably, arranged on the catheter shaft (2), and connected to the first moving element (310), and/or wherein the second surgical tool (12) is connected directly to the second moving element (320) and directly arranged on the catheter shaft (2), or wherein the second surgical tool 45
(12) is arranged on, in particular fixed to, a second tool-receiving casing (62) that is longitudinally movably, in particular slidably, arranged on the catheter shaft (2), and connected to the second moving element (320). The catheter of any of the preceding claims, wherein the first surgical tool (11 ) is connected to the first moving means (31 ) via a first distal connection opening (271 ) formed in a circumferential area of the catheter shaft (2), and/or wherein the second surgical tool (12) is movable on the catheter shaft (2) in the direction of the longitudinal axis (500) by the second moving means (32), wherein the second surgical tool (12) is connected to the second moving means (32) via a second distal connection opening (272) formed in a circumferential area of the catheter shaft (2). The catheter (100) according to any claims 6 to 12, wherein the first moving element (310) is formed as a wire and/or wherein the second moving element (320) is formed as a wire. The catheter (100) of any of the preceding claims, wherein the catheter shaft (2) comprises at least one further lumen (24) for receiving a guidewire and/or passing a substance, in particular fluid, therethrough. The catheter (100) of claim 14, wherein the catheter shaft (2) comprises at least one body fluid bypass opening (280) formed in a circumferential area of the catheter shaft (2) and being in fluid communication with the at least one further lumen (24), wherein the at least one body fluid bypass opening (280) is arranged proximally to the first surgical tool (11 ), the first surgical tool (11 ) being a proximal surgical tool and the second surgical tool (12) being a distal surgical tool, and wherein the first surgical tool (11) and the second surgical tool (12) are formed as inflatable balloons, and/or wherein the catheter shaft (2) comprises at least one fluid delivering opening (290) formed in a circumferential area of the catheter shaft (2) and being in fluid communication with the at least one further lumen (24), in particular wherein the at least one fluid delivering opening (290) is arranged between the first surgical tool (11) and the second surgical tool (12), the first surgical tool (11) and the second surgical tool (12) being formed as inflatable balloons.
PCT/GR2021/000033 2020-12-18 2021-05-20 Catheter WO2022129960A1 (en)

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