Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0133—Tip steering devices
  • A61M25/0136—Handles therefor
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
  • A61B10/02—Instruments for taking cell samples or for biopsy
  • A61B10/04—Endoscopic instruments, e.g. catheter-type instruments
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0133—Tip steering devices
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0133—Tip steering devices
  • A61M25/0138—Tip steering devices having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
  • A61M25/00—Catheters; Hollow probes
  • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
  • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
  • A61M25/0133—Tip steering devices
  • A61M25/0147—Tip steering devices with movable mechanical means, e.g. pull wires

Definitions

• heart surgery is an open-heart procedure conducted under general anesthesia, during which the heart is stopped and blood flow is controlled by a heartlung bypass machine.
• Traditional open surgery inflects significant patient trauma and discomfort and exposes the patient to a number of potential risks, such as an infection, stroke, renal failure, and adverse effects associated with the use of the heart-lung machine, for example.
• US 2018/0028779 A1 discloses an intravascular device delivery system that has an elongated member with a flexible hypotube.
• the hypotube can be rotationally keyed to a steerable catheter.
• the flexible hypotube includes one or more cuts to allow bending of the flexible hypotube within a first plane.
• the steerable catheter is steerable to bend the flexible hypotube within the first plane, and longitudinally movable relative to the flexible hypotube to allow distal movement of the steerable catheter relative to a distal end of the flexible hypotube.
• US 2018/0055636 A1 discloses a method of delivering a rigid intravascular device to a target location in a patient's heart includes positioning a distal tip of an elongated member of the intravascular device delivery system in a right atrium of a heart and moving the distal tip of the elongated member into a left atrium of the heart.
• a further object of the present disclosure is to provide a handle that facilitates using unilateral catheters.
• the method comprises: advancing the catheter through an opening punctured in a radial access opening, a femoral artery, a vein, or in a cubital vein towards the desired site, when reaching a curve or bifurcation in a blood vessel with a distal end of the catheter, pulling a pull wire of the catheter until a bend of a distal end of the catheter is detectable, rotating the catheter by rotating a handle of the catheter for aligning the radial orientation of the bend of the distal end of the catheter to correspond to a radial orientation of the curve or bifurcation in the blood vessel, pulling the pull wire by manually operating the handle of the catheter until the radius of the bend in the distal end of the catheter corresponds to a radius of the curve or bifurcation in the blood vessel, and pushing the handle for advancing the catheter through the curve or bifurcation.
• the method further comprises releasing the pull wire to straighten out the distal end of the catheter.
• the method comprises using a catheter according to above disclosure.
• Figure 1 is a perspective view of an embodiment of the catheter according to the present disclosure
• Figure 2 is the perspective view of the embodiment of the catheter in figure 1 without a flexible sheath
• Figure 3 is an enlarged part of the distal end of the catheter in figure 2
• Figure 4 is a sideview of the distal end of the catheter in figure 3
• Figure 5 is an exploded view of the distal part of the catheter in figure 3.
• Figure 9 is a partial cross section of the handle in figure 8.
• Figure 10 is an enlarged view of a part in figure 9,
• Figure 11 is a partial cross section of a handle according to an embodiment of the present disclosure.
• Figure 12 is a side view of a distal end of the catheter in bent state
• Figure 13 is a perspective view of a catheter with dilution apertures.
• DETAILED DESCRIPTION OF EXAMPLE EMBODIMENTS OF THE INVENTION The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which exemplary embodiments of the invention are shown. The invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided for thoroughness and completeness. Like reference character refer to like elements throughout the description.
• Figure 1 shows a flexible sheath 11 that is arranged on a flexible tube and enclosing a pull wire 8.
• a catheter 1 comprises a flexible and cylindrical hollow tube 2 at a distal end, wherein the flexible tube 2 has two opposite ends 3, 4, a first side 5 and a to the first side 5 opposite second side 6 extending between the two opposite ends 3, 4.
• the first side 5 has cutouts 7 along at least a part of its length, and wherein a pull wire 8 is arranged at the most distal end 3 and along the first side 5 of the flexible tube 2.
• the second side 6 has cutouts 9 along a corresponding length to the first side 5 and wherein the cutouts 7 on the first side are wider than the cutouts 9 on the second side 6.
• the pull wire 8 is arranged outside or externally of the flexible tube 2 which is part of allowing for these relatively small dimensions compared to prior art.
• the distance between the center of the cutouts 7 on the first side 5 is equal to the distance between the cutouts 9 on the second side 6 and the cutouts 7 on the first side 5 are also arranged directly opposite the cutouts 9 on the second side 6.
• One guard wire 10 is arranged on the catheter 1 to hold the pull wire 8 adjacent the flexible tube.
• the guard wire 10 is arranged circumferentially around the flexible tube 2. Further, one end of the guard wire 10 is attached to the distal end 3 of the flexible tube, the other end of the guard wire 10 is attached to the proximal end of the catheter, and the guard wire 10 is arranged in a coil around the flexible tube 2 between the distal end 3 of the flexible tube 2 and the proximal end of the catheter 1.
• the pull wire control 27 is movable between a distal position such that when in use and connected to a pull wire 8, the pull wire 8 connected to the holding device 26 is in a relaxed state, as in figure 9, and a proximal position in which the pull wire 8 is in a tense state such that the unidirectional catheter 1 is in a bent state.
• the pull wire control 27 is arranged circumferentially around the distal end 22 of the housing 24.
• the pull wire control 27 is turnably arranged such that it can be turned between a released state and a locked state. In the released state the pull wire control 27 is arranged such that it is movable between the distal position and the proximal position along the housing 24 to straighten or bend the catheter 1 , respectively.
• the holding device 26 is turnably arranged between a released state and a locked state together with the pull wire control 27, the holding device 26 having one periphery extension 29 that is possible to arrange in one of several recesses 30 arranged on the inside of the housing 24.
• the handle 21 comprises a spring 31 , wherein one end of the spring 31 is arranged in the housing 24 and the other end is arranged on the holding device 26 such that the holding device 26 is biased towards a locked state.
• a directing tube 32 is arranged at the distal opening 25 of and in line with the housing 24 and that pull wire control 27 is slidably arranged at its distal end 22 circumferentially around the directing tube 32.
• a protrusion 33 on the holding device 26 for connecting with a corresponding recess (not shown) on the inside of the pull wire control 27 and to thereby establish the connection between the pull wire control 27 and the holding device 26.
• Figure 12 shows the catheter 1 when the pull wire 8 is “pulled”, i.e. the distal section of the catheter or flexible tube 2 is bent.
• the cutouts 7 on the first side 5 are narrower in the bent state of the catheter 1 whereas the cutouts 9 on the second side 6 are slightly wider.
• the flexible tube 2 When the pull wire 8 is pulled the flexible tube 2 will bend with the pull wire 8 on the inside of the bend since it is placed on the first side 5 of the flexible tube 2 where the cutouts 7 are larger compared to the cutouts 9 on the second side 6. Thus, the flexible tube is biased to bend in the direction on the side where the pull wire 8 is arranged.
• the catheter is covered with a flexible sheath (11 in figure 1) and in order for this sheath not to be ripped or cut by the pull wire 8, a guard wire 10 is arranged in a coil round the flexible tube 2 such that the guard wire 10 keeps the pull wire 8 close to the flexible tube 2 when the catheter is in a bent state.
• the guard wire By having the guard wire, the thickness of the flexible sheath can be kept to a minimum and thus allowing for the small dimensions of the catheter 1.
• the pull wire 8 is released to straighten out the distal end 3 of the catheter 1.
• a further function of the present catheter 1 is to have dilution apertures 34 on the side at the distal end of the catheter in order to be able to release contrast agents.
• Figure 13 shows an example with such apertures 34.
• the apertures 34 should not be located on the outer curve of the deflectable part of the catheter 1 to avoid protrusion of small devices that are being fed through the catheter.

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Engineering & Computer Science (AREA)
• Veterinary Medicine (AREA)
• Public Health (AREA)
• General Health & Medical Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Biophysics (AREA)
• Pulmonology (AREA)
• Anesthesiology (AREA)
• Hematology (AREA)
• Surgery (AREA)
• Molecular Biology (AREA)
• Mechanical Engineering (AREA)
• Medical Informatics (AREA)
• Pathology (AREA)
• Radiology & Medical Imaging (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Media Introduction/Drainage Providing Device (AREA)

Applications Claiming Priority (3)

Publications (1)

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Family Applications (1)

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• 2023
  • 2023-03-23 CA CA3246475A patent/CA3246475A1/en active Pending
  • 2023-03-23 WO PCT/EP2023/057398 patent/WO2023180414A1/en not_active Ceased
  • 2023-03-23 CN CN202380042814.9A patent/CN119255836A/zh active Pending
  • 2023-03-23 EP EP23713111.5A patent/EP4496614A1/en active Pending
  • 2023-03-23 JP JP2024556408A patent/JP2025510116A/ja active Pending

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