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WO2024120556A1 - Kit pour la dilatation de canaux pour l'insertion de drains et de cathéters dans des cavités corporelles et des organes - Google Patents

Kit pour la dilatation de canaux pour l'insertion de drains et de cathéters dans des cavités corporelles et des organes Download PDF

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Publication number
WO2024120556A1
WO2024120556A1 PCT/CZ2023/050086 CZ2023050086W WO2024120556A1 WO 2024120556 A1 WO2024120556 A1 WO 2024120556A1 CZ 2023050086 W CZ2023050086 W CZ 2023050086W WO 2024120556 A1 WO2024120556 A1 WO 2024120556A1
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WO
WIPO (PCT)
Prior art keywords
dilator
channel
fixation device
dilatation
tube
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CZ2023/050086
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English (en)
Inventor
Lubos Sobotka
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fakultni Nemocnice Hradec Kralove
Original Assignee
Fakultni Nemocnice Hradec Kralove
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 Fakultni Nemocnice Hradec Kralove filed Critical Fakultni Nemocnice Hradec Kralove
Publication of WO2024120556A1 publication Critical patent/WO2024120556A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3415—Trocars; Puncturing needles for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • 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
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B2017/3433—Cannulas with different outer diameters of the cannula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3492—Means for supporting the trocar against the body or retaining the trocar inside the body against the outside of the body
    • 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
    • A61M27/00—Drainage appliance for wounds or the like, i.e. wound drains, implanted drains

Definitions

  • the present invention relates to a kit for inserting catheters (such as drains and cannulas) into body cavities and organs, which can be used for dilatation of channels into body cavities and some organs.
  • catheters such as drains and cannulas
  • the use of the kit is especially for individuals with infectious and necrotic foci in the abdominal cavity, retroperitoneum, chest cavity, as well as for dilation of channels into hollow organs (trachea, stomach, uterus, urinary system). Its intended use is also for laparoscopic surgery.
  • Use of said kit enables to dilate channels and entries more safely, leading to more efficient insertion of drains, performing laparoscopic surgeries and instrumental use in body cavities and necrotic foci, dilatation of openings into respiratory tract (tracheostomia), and for laparoscopic and robotic surgeries.
  • Drainage is the insertion of a drain (plastic tube) through the skin into a place with accumulated unwanted fluid (secretion, pus, blood, necrotic tissue, pancreatic juices, etc.).
  • the purpose of drainage is to remove this accumulated unwanted fluid from the body.
  • necrotic (dead) tissue is often necessary to remove necrotic (dead) tissue from the body, which can block the passage of the drain and thus invalidate its use.
  • drainage is performed by inserting a thin drain using an introducer. In case it is desirable to insert a larger drain, it is necessary to subsequently dilate the drainage channel to the required size.
  • Dilators are either rigid or flexible (especially pushes to dilatation - bougie).
  • the principle of both methods is the same, an increasingly larger dilator is introduced (either by using a guidewire or without a guidewire) into the channel to be dilated.
  • the disadvantage of the mentioned dilation method is the risk of damage to the surrounding tissues and the fact that it may not be possible to introduce a larger dilator into the channel, which may deform, because the dilator is inserted into an unreinforced channel (for example, a thick layer of subcutaneous tissue and muscle that needs to be dilated).
  • the state of the art thus far lacks a device that would enable an easy, gentle and cheap method of dilating a drainage channel, while minimizing damage of the surrounding tissue.
  • the aim of the present invention is to enable dilatation of narrow channels that are created after the insertion of thin drains by means of a puncture needle into a foci, a cavity or an organ (trachea, stomach).
  • the insertion controlled using ultrasound or X-ray methods.
  • the present device is intended for subsequent dilatation of the channel through which the thin drain is introduced.
  • a set of dilators is used for dilatation, and the method of dilatation is unique in that a larger dilator is introduced inside the narrower dilator, which enables to gradually and gently dilatate the channel without any damage to the surrounding tissues.
  • the distance (depth) to which said dilator is inserted is controlled with a fixation device (spacing ring). The fixation device enables to safely adjust the length of the channel being dilatated.
  • An object of the present invention is thus a kit for dilatation of channels for inserting drains into body cavities and organs, which comprises at least two channel dilators for inserting drains, which have mutually different outer diameters, and a fixation device (as described below) for securing the set depth of the dilated channel.
  • said kit comprises a plurality of channel dilators for inserting drains having their outer diameter gradually increasing in the range of from 5 mm to 20 mm, wherein the step of increase is preferably in the range of from 0,5 mm to 3 mm, more preferably the step of increase is preferably in the range of from 1 mm to 2 mm.
  • the set of dilators is intended for a single use.
  • the dilator of a channel formed after insertion of a thin drain has a shape of a tube (cylinder), which is provided with a dilatation slot along its entire length.
  • the elasticity of the material in combination with said longitudinal dilatation slot enables to enlarge the size (width) of the dilatation slot and thereby increasing the diameter of said tube.
  • the dilatation slot thus enables to insert a larger dilator into a narrower dilator, and thereby gradually increase the diameter of the drainage channel.
  • the dilator can therefore be flexibly opened along the dilatation slot.
  • the narrower dilator thus opens along the dilatation slot, thereby gently widening the channel.
  • the narrower dilator is removed, followed by inserting a further, larger dilator (preferably 0.5 to 3 mm larger) into the dilator currently inserted in the drainage channel. Said steps are repeated until the desired channel diameter is achieved.
  • the insertion depth (length of the dilated canal) is secured using the fixation device described below.
  • the insertion depth (the length of the channel to be dilatated) is controlled using the fixation device described below.
  • the drainage channel is thus reinforced by at least one dilator throughout the duration of the dilatation, so there is no risk of deformation of the channel by contraction or shift of the surrounding tissues.
  • the surface of the dilator tube is preferably smooth.
  • the edges of the dilatation slot can be smooth or they can be provided with a mutually complementary connecting means adapted to prevent the overlapping of the edges of the dilatation slot and thereby reducing the outer diameter of the dilator (the connecting means thus fixes the minimum diameter of the dilator tube).
  • Said complementary connecting means can be a set of recesses and protrusions (teeth) or a groove along one side of the slot and a longitudinal protrusion (tongue) along the other side. The tongue is inserted in the groove or the teeth and the recesses are inserted into each other.
  • the width of the dilatation slot is in the range of from 0 to 12 mm, depending on the diameter of the dilator. At rest, the width of the dilatation slot is typically 0 mm, while when a larger dilator is being inserted, the dilatation slot of the narrower dilator expands (depending on the diameter of the larger dilator) up to 12 mm. The flexibility of the dilator material allows this expansion without compromising its strength or causing it to rupture.
  • the wall thickness of the dilator tube is preferably in the range of from 0.5 to 2 mm, more preferably from 0.7 to 1.2 mm, even more preferably 1 mm.
  • the biocompatible plastic is selected from the group comprising polyethylene, polyamide (for example polyamide 12, PA 2200), polyurethane, Teflon, EVA (polyethylene vinyl acetate)), polyvinyl chloride (PVC), polypropylene (PP), low density polyethylene (LDPE), high density polyethylene (HDPE), polystyrene (PS), acrylonitrile butadiene styrene (ABS), methyl methacrylate-acrylonitrile- butadiene-styrene (MABS), polycarbonate (PC), polyoxymethylene (POM), thermoplastic elastomer (TPE).
  • polyethylene polyamide
  • PA 2200 polyurethane
  • EVA polyethylene vinyl acetate
  • PVC polyvinyl chloride
  • PP polypropylene
  • LDPE low density polyethylene
  • HDPE high density polyethylene
  • PS polystyrene
  • ABS acrylonitrile butadiene styrene
  • MABS methyl me
  • the outer diameter of the tube of the dilator is in the range of from 5 mm to 20 mm, for example 5, 7, 9, 11, 13, 15, 17, 19 or 20 mm.
  • the dilator further comprises a broadening, preferably of a conical shape, on one end of the tube. Said broadening facilitates insertion of the larger dilator into the narrower one, which is the principle of the here described dilatation.
  • the outer diameter of the broadening at its widest part is in the range of from 1.25 to 1.5-times the outer diameter of the tube.
  • the ratio of the length of the broadened portion to the total length of the dilator tube is in the range of from 1 :5 to 1 :30, preferably from 1 : 10 to 1 :20.
  • the tube of the dilator is provided with a stopper, provided on the outer wall of the tube.
  • the stopper prevents the insertion of one end (preferably of the broadened end) of the dilator into the drainage channel.
  • said stopper may be provided with information about the diameter of said dilator.
  • the stopper is made of the same material as the entire dilator of the drainage channel.
  • the information about the diameter of said dilator may be printed, glued, cast, etc. on the stopper. This facilitates the selection of successive sizes of dilators when performing dilatation of the drainage channel.
  • the stopper may be in the form of a protrusion, a flange or a rim.
  • the stopper may be used to hold the dilator, in which case it is preferred if the stopper is in a form of a protrusion in the shape of a plate or of a prism, for example a rectangular cuboid, with a surface area (plate or base of the prism) in the range of from 1 to 5 cm 2 , more preferably in the range of from 1,5 to 3 cm 2 .
  • the stopper is preferably located outside said broadening, i.e. on the straight outer wall of the tube (cylinder), at the region between the cylindrical and the broadened part of the dilator.
  • the dilator is a tube with length in the range of from 10 to 30 cm, made of polyethylene, polyamide, polyurethane, Teflon or EVA, said tube being provided with a dilatation slot along the entire length of the tube.
  • the dilatation slot is provided with mutually complementary groove along one side of the slot and a tongue along the other side. At rest, the tongue is inserted in the groove and the width of the dilatation slot is thus 0 mm.
  • the wall thickness of the dilator tube is in the range of from 0.5 to 1.2 mm, and the outer diameters of the dilator tubes range from 5 mm to 20 mm in 1 mm increments.
  • Said dilator is at one end provided with a broadening of a conical shape, wherein the outer diameter of the broadening at its widest part is in the range of from 1.25 to 1.5-times the outer diameter of the tube.
  • the ratio of the length of the broadened portion to the total length of the dilator is in the range of from 1 : 10 to 1 :20.
  • the dilator further contains a stopper in the form of a plate, provided with the information about the outer diameter of said dilator. Said stopper is located at the region between the cylindrical and the broadened part of the dilator.
  • the kit for inserting drains into body cavities and organs also includes a fixation device, suitable for adjusting the desired depth of the dilated channel.
  • the fixation device comprises a hollow cylindrical body provided, at one end, with a flange for positioning the fixation device on the body of the subject around the entry of the drainage channel, and, at the opposite end, with at least one protrusion for preventing the insertion of one (preferably the broadened) end of the dilator into the drainage channel.
  • the protrusion of the fixation device is complementary to the stopper of the channel dilator, wherein said protrusion is in this case configured to prevent the stopper of the dilator from passing through the fixation device.
  • the length of the cylindrical body of the fixation device is at least 3 cm, preferably in the range of from 4 to 10 cm, more preferably 5 cm.
  • the inner diameter of the cylinder of the fixation device is preferably in the range of from 10 to 30 mm. In order for the fixation device to be complementary to the dilator described above, the inner diameter of the cylinder of the fixation device must be larger than the outer diameter of the dilator.
  • the protrusion of the fixation device is complementary to the stopper of the dilator for dilating the drainage channel, said protrusion being configured to prevent the dilator stopper from passing through the fixation device.
  • the thickness of the wall of the cylindrical body of the fixation device is preferably in the range of from 2 to 4 mm.
  • the material of the fixation device is a biocompatible plastic, preferably selected from the group comprising polyethylene, polyamide (for example polyamide 12, PA 2200) polyurethane, Teflon, EVA, polyvinyl chloride (PVC), polypropylene (PP), low density polyethylene (LDPE), high density polyethylene (HDPE), polystyrene (PS), acrylonitrile butadiene styrene (ABS), methyl methacrylate-acrylonitrile-butadiene-styrene (MABS), polycarbonate (PC), polyoxymethylene (POM), thermoplastic elastomer (TPE).
  • PVC polyvinyl chloride
  • PP polypropylene
  • LDPE low density polyethylene
  • HDPE high density polyethylene
  • PS polystyrene
  • ABS acrylonitrile butadiene styrene
  • MABS methyl methacrylate-acrylonitrile-butadiene-styrene
  • PC poly
  • the position of the protrusion relative to the longitudinal axis of the cylindrical body of the fixation device is adjustable, for example by means of an adjustable flange.
  • the cylindrical body of the fixation device may be provided with a recess, for example a U-shaped recess, which allows the protrusion to be fixed against its rotation about the vertical axis of the cylinder.
  • a recess for example a U-shaped recess
  • the depth of said protrusions inwards of the cylinder is identical to the wall thickness of the fixation cylinder.
  • the adjustable flange will only allow vertical adjustment of the position of the protrusion relative to the longitudinal axis of the cylindrical body of the fixation device, but not its rotation.
  • the fixation device comprises at least two (preferably just two) protrusions, more preferably arranged opposite to each other and at the same distance from the plane of the flange. This arrangement allows the simultaneous prevention of the passage of one end of both the narrower and the larger dilator into the dilated channel during the insertion of the larger dilator into the narrower one. If both dilators are provided with a stopper at the same distance from the end of the dilator, the protrusions on the fixation device ensure that both dilators are inserted to the same depth in the tissue of the subject.
  • the cylindrical body of the fixation device is provided with at least two (preferably just two) recesses, for example a U-shaped recess to allow fixation of the projections against rotation about the vertical axis of the cylinder.
  • said two recesses are located opposite each other in the cylinder wall of the fixation device.
  • the cylindrical body of the fixation device is provided with at least two (preferably with just two) recesses, e.g. with a U-shaped recess, which enable fixation of the protrusions with regard to the rotation about the longitudinal axes of the cylinder.
  • said two recesses are provided opposite to each other in the wall of the cylinder of the fixation device.
  • Said kit for dilatation of channels for inserting drains into body cavities and organs may further comprise an external sterile packaging.
  • Both the dilator and the fixation device can be manufactured using conventional techniques such as 3D printing, mould casting, pressing, injection moulding, blow moulding, injection blowing, extrusion, thermoforming or turning.
  • the object of the present invention is also a method of dilatation of channels for inserting drains into body cavities and organs by using the above-described kit, wherein said method comprises the steps of: a) providing the kit for dilatation of channels for inserting drains into body cavities and organs defined above; b) performing skin incision and inserting the drain insertion tube using the drain introducer into the target organ; c) removing the drain introducer from the wound;
  • a skin incision is performed at the place where drainage is to be carried out.
  • a drain insertion tube is inserted into the incision using a drain introducer.
  • the drain introducer is then removed from the wound, and the fixation device is positioned (put on) so that its flange is positioned on the body of the subject around said insertion tube.
  • the height of the protrusion adapted to prevent the passage of the dilator through the fixation device is adjusted (i.e. the vertical distance of this protrusion from the flange of the fixation device is adjusted).
  • the dilator with the smallest diameter is placed from the outside around the insertion tube (a drain or a catheter) and inserted into the drainage channel along the insertion tube into the body of the subject, thereby causing the first dilation of the channel.
  • the depth of insertion of the dilator into the channel is regulated by the protrusion of the fixation device, which prevents deeper penetration of the dilator (the stopper of the dilator stops on the protrusion of the fixation device). Then, the drain insertion tube is removed from the body of the subject, and a dilator of a larger diameter than the first dilator is inserted into the introduced first dilator.
  • the insertion of the larger dilator into the narrower dilator is possible because of the longitudinal dilatation slot that flexibly opens.
  • the insertion of the larger dilator is thus achieved without any friction between the inner wall of the channel and the outer surface of the larger dilator.
  • the originally narrower dilator (the outer one of the two dilators) is removed from the channel, while the larger dilator stays inserted, thereby widening the channel.
  • the steps of inserting a larger dilator is repeated using gradually increasing outer diameter of the dilator until the required dimension of the drain channel is reached. Finally, the drain of the required diameter is inserted into the dilated channel, and the inserted dilator and fixation device are removed.
  • the above-described invention facilitates dilatation (increasing the diameter) of the channel during the insertion of a drain, so that during the dilatation the dilator does not directly rub against the inner wall of the tissue channel and thus does not cause damage to the tissue.
  • the larger dilator is introduced inside the narrower dilator (this is made possible by the dilatation slot, which opens up in the narrower dilator and thus widens the channel), and therefore no damage to the surrounding tissues occurs because the larger dilator does not rub its outer surface against the surrounding tissues during insertion, but only against the inner surface of the narrower dilator. Therefore, the diameter of the drainage channel gradually increases and the fixation device ensures that the dilator is only inserted to a predetermined depth.
  • the drainage channel is reinforced with at least one dilator throughout the dilatation, so that there is no risk of deformation of the channel by contraction or shift of the surrounding tissues.
  • Fig. 1 Detail of the dilatation slot, provided with mutually complementary recesses and protrusions.
  • Fig. 2 Demonstration of the introduction of a larger dilator into a narrower dilator, during which the dilatation slot widens.
  • Fig. 3 Dilator containing a conical broadening and a stopper.
  • Example 1 Manufacturing the dilator 1 and the fixation device 6
  • a set of 16 dilators 1 for dilating the drainage channel were constructed.
  • a schematic representation of the dilator is shown in Fig. 3.
  • the dilator was a 20 cm long tube 2, made of polyethylene, which was provided with a dilatation slot 3 along its entire length.
  • the dilators 1 were made using injection moulding.
  • the dilatation slot 3 was provided with a complementary groove along one side of the slot and a tongue along the other side. At rest state (when the tongue is inserted in the groove), the dilatation slot 3 had a width of 0 mm.
  • the wall thickness of the dilator tube 2 was 1 mm.
  • the outer diameter of the dilator tube 2 was graduated in 1 mm increments ranging from 5 mm to 20 mm.
  • the dilators 1 contained conical broadening 4 at one end, wherein the outer diameter of the broadening 4 at its widest part was 1.3 -times the outer diameter of the tube 2.
  • the length of the broadened part was 1 cm.
  • the dilator 1 was provided with a stopper 5 in the shape of a plate, stamped with information about the outer diameter of the particular dilator E The stopper 5 was located at the region between the cylindrical and the broadened part of the dilator 1.
  • the fixation device 6 was made by 3D printing. Polyamide 12 was used as the material.
  • This fixation device 6 (Fig. 4) consisted of a hollow cylindrical body 7, provided at one end with a flange 8 intended to be placed on the subject's body around the entry of the drainage channel, and at the opposite end with two protrusions 9 located on a rim and configured to prevent the stopper 5 of the dilator 1 from passing through the fixation device 6.
  • the length of the cylindrical body 7 of the fixation device 6 was 5 cm, and the inner diameter of the cylindrical body 7 of the fixation device 6 was 30 mm.
  • the wall thickness of the cylindrical body 7 of the fixation device 6_ was 3 mm.
  • the rim of the fixation device 6 was vertically adjustable by means of a screw, and its distance from the flange 8 could be adjusted.
  • the cylindrical body 7 of the fixation device 6 was provided with two U-shaped recesses.
  • the depth of these recesses towards the inside of the cylinder was identical to the wall thickness of the fixation cylinder, i.e. 3 mm.
  • the adjustable rim (flange) allowed only vertical adjustment of the position of the protrusions 9 relative to the longitudinal axis of the cylindrical body 7 of the fixation device 6, but not its rotation.
  • a set of three dilators 1 was produced in an analogous way (3D printing), the material in this case was polyamide 12. Their construction is shown in Fig. 1.
  • the dilator 1 was a 15 cm long tube 2, which was provided with a dilatation slot 3 along its entire length.
  • the dilatation slot 3 was provided with complementary teeth and recesses. At rest state, the dilatation slot 3 was 1 mm wide.
  • the wall thickness of the dilator tube 2 was 0.5 mm.
  • the outer diameter of the dilator tubes 2 was 5 mm, 8 mm and 10 mm.
  • Example 2 Dilating a channel and providing drainage in vitro - use on non -biological material The insertion of a larger dilator into a narrower dilator is shown in Fig. 2, with the expansion of the dilatation slot 3. The method of dilating the channel for introducing the drain into the body cavities and organs was performed in vitro with a set of 16 dilators 1 and the fixation device 6 according to Example 1 as follows:
  • a skin incision was performed and a drain insertion tube was inserted into the incision using a drain introducer.
  • the drain introducer was subsequently removed from the wound and the fixation device 6 according to Example 1 was placed (put on) onto the drain insertion tube so that its flange 8 was positioned on the body of the subject around said insertion tube.
  • the subject in this case was a combination of polyamide and foam.
  • the height of the protrusions 9 was adjusted by the rim to 4 cm above the surface of the subject.
  • a dilator 1 with the smallest diameter (5 mm) was placed onto the insertion tube from the outside and inserted into the channel along the insertion tube into the body of the subject. This caused the first dilatation of the channel.
  • the depth of insertion of the dilator 1 into the channel was controlled by the protrusion 9 of the fixation device 6, which prevented the stopper 5 of the dilator 1 from penetrating through the fixation device 6 (the stopper 5 of the dilator 1 stopped against the protrusion 9 of the fixation device 6).
  • the drain insertion tube was removed and a 6 mm diameter dilator 1 was inserted into the already inserted narrower dilator.
  • the insertion of the larger dilator into the narrower dilator was made possible by the longitudinal dilatation slot 3, which opened elastically. The insertion of the larger dilator thus occurred without any friction between the inner wall of the channel and the outer surface of the larger dilator.
  • the originally narrower dilator (the outer of the two dilators) was then removed from the channel, leaving only the larger dilator in place, thereby widening the channel.
  • the procedure for the insertion of the larger dilator was repeated with progressively increasing outer diameter of the dilator until the desired dimension for the drain was reached, which corresponded to the outer diameter of the largest dilator, i.e. 20 mm. Finally, a drain of the required thickness was introduced into the dilator 1, the introduced dilator 1 was removed and the fixation device 6 was removed as well.
  • Example 3 Dilatation of the channel and providing drainage in vitro on biological material The insertion of a larger dilator into a narrower dilator as shown in Fig. 2 was performed analogically as in Example 2.
  • the subject in this case was a sample of beef meat with a thickness of 3.5 cm.
  • the height of the protrusions 9 was adjusted using the rim to 4 cm above the surface of the subject.
  • a dilator 1 with the smallest diameter (5 mm) was placed onto the insertion tube from the outside and inserted into the channel along the insertion tube into the body of the subject. This caused the first dilatation of the channel.
  • the depth of insertion of the dilator 1 into the channel was controlled by the protrusion 9 of the fixation device 6, which prevented the stopper 5 of the dilator 1 from penetrating through the fixation device 6.
  • the drain insertion tube was removed and a 6 mm diameter dilator 1 was inserted into the already inserted narrower dilator.
  • the insertion of the larger dilator into the narrower dilator was made possible by the longitudinal dilatation slot 3, which opened elastically. The insertion of the larger dilator thus occurred without any friction between the inner wall of the channel and the outer surface of the larger dilator.
  • the originally narrower dilator (the outer of the two dilators) was then removed from the channel, leaving only the larger dilator in place, thereby widening the channel.
  • the procedure for the insertion of the larger dilator was repeated with progressively increasing outer diameter of the dilator until the desired dimension for the drain was reached, which corresponded to the outer diameter of the largest dilator, i.e. 20 mm. Finally, a drain of the required thickness was introduced into the dilator 1, the introduced dilator 1 was removed and the fixation device 6 was removed as well.
  • Example 4 Dilating a channel and providing drainage on a (dead) animal
  • the subject in this case was a piglet.
  • the height of the protrusions 9 was adjusted using the rim to 5 cm above the surface of the subject.
  • a dilator 1 with the outer diameter of 5 mm was placed onto the insertion tube from the outside and inserted into the channel along the insertion tube into the body of the subject. This caused the first dilatation of the channel.
  • the depth of insertion of the dilator 1 into the channel was controlled by the protrusion 9 of the fixation device 6, which prevented the stopper 5 of the dilator 1 from penetrating through the fixation device 6.
  • the drain insertion tube was removed and a 6 mm outer diameter dilator 1 was inserted into the already inserted narrower dilator.
  • the originally narrower dilator (the outer of the two dilators) was then removed from the channel, leaving only the larger dilator in place, thereby widening the channel.

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  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention se rapporte à un kit pour la dilatation de canaux pour insérer des drains ou des canules et des instruments chirurgicaux dans des cavités corporelles et des organes, comprenant au moins deux dilatateurs de canal à fente (1) ayant des diamètres externes différents, et un dispositif de fixation (6) pour ajuster la profondeur définie du canal dilaté, le dilatateur de canal (6) ayant une forme tubulaire, le diamètre externe du tube de dilatateur étant situé dans la plage allant de 5 mm à 20 mm, la largeur de la fente de dilatation étant située dans la plage allant de 0 à 12 mm, et le matériau dudit dilatateur et dispositif de fixation étant du plastique biocompatible. Le dispositif de fixation (6) est pourvu d'une bride (8) destinée à être positionnée sur le corps du sujet et, à l'extrémité opposée, d'une saillie (9) destinée à empêcher une insertion excessive du dilatateur (1).
PCT/CZ2023/050086 2022-12-07 2023-12-04 Kit pour la dilatation de canaux pour l'insertion de drains et de cathéters dans des cavités corporelles et des organes Ceased WO2024120556A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CZ2022-512A CZ2022512A3 (cs) 2022-12-07 2022-12-07 Dilatátor, fixační zařízení a sada pro zavádění drénu do tělesných dutin a orgánů
CZPV2022-512 2022-12-07

Publications (1)

Publication Number Publication Date
WO2024120556A1 true WO2024120556A1 (fr) 2024-06-13

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CZ2023/050086 Ceased WO2024120556A1 (fr) 2022-12-07 2023-12-04 Kit pour la dilatation de canaux pour l'insertion de drains et de cathéters dans des cavités corporelles et des organes

Country Status (2)

Country Link
CZ (1) CZ2022512A3 (fr)
WO (1) WO2024120556A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5275611A (en) * 1990-11-20 1994-01-04 Innerdyne Medical, Inc. Tension guide and dilator
US20110144687A1 (en) * 2009-12-10 2011-06-16 Kleiner Jeffrey Lateral Based Retractor System
US20160278755A1 (en) * 2008-12-18 2016-09-29 Imds Lateral access system for the lumbar spine
WO2018140371A1 (fr) * 2017-01-25 2018-08-02 Rmvidlund Llc Dispositifs d'accès et de fermeture de vaisseau sanguin et procédés d'utilisation associés
US20210338282A1 (en) * 2020-05-01 2021-11-04 Ethicon Llc Universal size multi-walled elastomer cannula depth limiter

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5275611A (en) * 1990-11-20 1994-01-04 Innerdyne Medical, Inc. Tension guide and dilator
US20160278755A1 (en) * 2008-12-18 2016-09-29 Imds Lateral access system for the lumbar spine
US20110144687A1 (en) * 2009-12-10 2011-06-16 Kleiner Jeffrey Lateral Based Retractor System
WO2018140371A1 (fr) * 2017-01-25 2018-08-02 Rmvidlund Llc Dispositifs d'accès et de fermeture de vaisseau sanguin et procédés d'utilisation associés
US20210338282A1 (en) * 2020-05-01 2021-11-04 Ethicon Llc Universal size multi-walled elastomer cannula depth limiter

Also Published As

Publication number Publication date
CZ2022512A3 (cs) 2024-06-19

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