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WO2020094620A1 - Appareil médical, élément auxiliaire pour une utilisation en tant que partie d'un tel appareil médical et d'un élément de liaison pour une utilisation en tant que partie d'un tel élément auxiliaire - Google Patents

Appareil médical, élément auxiliaire pour une utilisation en tant que partie d'un tel appareil médical et d'un élément de liaison pour une utilisation en tant que partie d'un tel élément auxiliaire Download PDF

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Publication number
WO2020094620A1
WO2020094620A1 PCT/EP2019/080196 EP2019080196W WO2020094620A1 WO 2020094620 A1 WO2020094620 A1 WO 2020094620A1 EP 2019080196 W EP2019080196 W EP 2019080196W WO 2020094620 A1 WO2020094620 A1 WO 2020094620A1
Authority
WO
WIPO (PCT)
Prior art keywords
lock
medical device
expansion element
expansion
blood vessel
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/EP2019/080196
Other languages
German (de)
English (en)
Inventor
Halil Krasniqi
Maic Strasser
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Priority to DE112019005561.5T priority Critical patent/DE112019005561A5/de
Publication of WO2020094620A1 publication Critical patent/WO2020094620A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0662—Guide tubes
    • A61M2025/0687—Guide tubes having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
    • 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
    • A61M25/0102—Insertion or introduction using an inner stiffening member, e.g. stylet or push-rod
    • 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
    • A61M25/06—Body-piercing guide needles or the like
    • A61M25/0606—"Over-the-needle" catheter assemblies, e.g. I.V. catheters

Definitions

  • auxiliary element for use as part of such a medical device and connecting element for use as part of such an auxiliary element
  • the invention relates to a medical device according to the preamble of claim 1, an auxiliary element for use as part of such a medical device according to claim 16 and a connecting element for use as part of such an auxiliary element according to claim 17.
  • a blood vessel (usually an artery) is punctured at one point and a sluice is inserted in sections into the blood vessel such that a first end of the sluice remains within the blood vessel during treatment and that a second end of the sluice is located outside the body .
  • This lock has a through opening.
  • the necessary instruments are brought into the interior of the artery by means of this lock. These instruments are usually located at the end of a wire that is pushed into the blood vessel.
  • stands can be set, blood vessels narrowed or expanded, or arterial calcifications can also be removed using micro-cutters.
  • the expansion elements are used in the form of balloons, which are pushed to the appropriate place by means of a wire and then filled with a saline solution via a hose that also extends through the lock.
  • Access is usually via a main artery in the groin, which must be punctured in a first step, then the first end of the Being able to position the sluice within the artery.
  • This method is known to the experts and in particular to the surgeons specializing in it and need not be explained in detail here.
  • the object of the present invention is to develop a generic medical device in such a way that a blood vessel can be treated on both sides of the puncture site during only one operation.
  • a medical device with the features of claim 1.
  • An auxiliary element for use with a lock for forming a medical device according to the invention is specified in claim 16.
  • a connecting element for use as part of such an auxiliary element is specified in claim 17.
  • the basic idea of the invention is to create a temporary pivot bearing body at the first end of the lock, by means of which the lock, the first end of which is located within the blood vessel, can be pivoted, where the pivot bearing body both slips out during the pivoting movement of the first end of the sheath as well as injury to the blood vessel is prevented.
  • the diameter of the swivel body must be naturally larger than the diameter of the second end of the lock. That is why it is designed as an expansion body (otherwise it would not fit through the lock).
  • a connecting element is provided, at the front end of which the expansion element is arranged.
  • the expansion element connects to the first end of the lock during its use, for which purpose the connecting element has a positioning means for positioning the connecting element with respect to the lock.
  • This positioning means can in particular be designed as a stop.
  • the positioning means of the connecting element could be part of a releasable snap-in connection.
  • stop bell-shaped In order to create good compatibility with existing locks, it may be preferable to make the stop bell-shaped.
  • the connecting element can have a connecting section, the length of which corresponds to the length of the through opening of the lock and thus generally also to the length of the lock itself.
  • this connecting section can be essentially rigid.
  • the expansion element in such a way that it automatically ("automatically") when it reaches its use position expanded state, for example because it is under tension.
  • the expansion element is an elastic balloon and the connecting element is or has a line leading into this balloon.
  • an actuating element is necessary, which in particular can be a piston-cylinder unit, that is to say a syringe.
  • An expansion element in the form of a balloon made of a rubber-elastic material has the advantage of being easy to manufacture and of great operational reliability. In principle, however, the use of a mechanical expansion element is also conceivable.
  • the expanded expansion element can be essentially round, but can also be designed in the form of a disk.
  • a mechanical expansion element this can be designed, for example, in the form of an “inverted umbrella”, so that in this case too, the pivot bearing body formed from the expanded expansion element has a convex surface for contact with the inner wall of the blood vessel.
  • the expansion element does not necessarily have to increase its volume when expanding (as is the case with a balloon), but it may also suffice that it expands when it expands its surface facing the blood vessel wall.
  • the connecting element has a shut-off valve, by means of which the connection between the actuating element and the balloon can be interrupted, so that an unintentional Visible reflux of liquid (usually a saline solution) from the balloon and thus premature reduction of the expansion element is excluded.
  • a shut-off valve by means of which the connection between the actuating element and the balloon can be interrupted, so that an unintentional Visible reflux of liquid (usually a saline solution) from the balloon and thus premature reduction of the expansion element is excluded.
  • the first end of the lock and / or the front end of the connecting section of the connecting element can carry a metal element, provided that these components do not consist of metal anyway.
  • the expansion element can consist entirely or partially of metal or can also carry a metal element.
  • the expansion element is a balloon, it is particularly preferable here that at the front end - preferably on the inside of the balloon - a small metal element is connected to the balloon, for example glued.
  • FIG. 2 the lock from FIG. 1 and a so-called soul, which is passed through the lock
  • Figure 3 shows an auxiliary element according to the invention for use with the
  • Figure 4 shows the auxiliary element of Figure 3 in a state in which its
  • Expansion element is expanded, 5 shows the lock of FIG. 1 in a state of use in which its first end is located within a blood vessel,
  • FIG. 6 shows the lock of FIG. 5 and the auxiliary element of FIG. 3, a connecting element of the auxiliary element being in a defined position with respect to the lock,
  • FIG. 7 that shown in FIG. 6, in a state in which the expansion element of the auxiliary element is in an expanded state
  • FIG. 8 to the one shown in FIG. 7 while carrying out a directional change, FIG. 13 changing the lock, FIG. 14 the lock as shown in FIG. 12 after the auxiliary element has been removed again.
  • FIG. 1 shows a so-called lock 10, as is known in the prior art.
  • This lock 10 extends from a first end 10a to a second end 10b and has a through opening which extends over the entire length of the lock 10, that is to say from the first end 10a to the second end 10b.
  • a front section 12 of the lock is designed essentially in the form of a straight tube and a rear section 14 of the lock 10 is widened with respect to this tubular front section 12.
  • the through opening widens, which facilitates the insertion of elements into the second end 10b of the lock 10.
  • FIG. 2 shows the lock of FIG. 10, a so-called core 20 being introduced into this lock 10. This has a greater length than the lock, so that when the core 20 is pushed through the lock 10, a tip 22 of the core 20 protrudes from the first end 10a of the lock 10 and a handle 24 of the core 20 outside the second End 10b of the Lock 10 is positioned (so in a way behind the lock). The tip 22 serves to puncture a blood vessel.
  • FIGS. 3 and 4 show a preferred exemplary embodiment of an auxiliary element 30 according to the invention, which is used together with the lock 10.
  • This auxiliary element 30 has three basic elements, namely a connecting element 40, an expansion element 50 in the form of a balloon and an actuating element 60 in the form of a piston-cylinder unit, ie in the form of a syringe.
  • the connecting element 40 can be regarded as consisting of a connecting section 42 and a connecting section 46.
  • the transition between these two sections is formed in the form of a stop 44, which is bell-shaped in the exemplary embodiment shown (and this is also preferred).
  • the connecting element 40 extends from a front end 42a (this is also the front end of the connecting section 42) to a rear end 46b (this is also the rear end of the connecting section 46).
  • the expansion element 50 that is to say the balloon in the exemplary embodiment shown, is arranged at the front end 42a.
  • FIG. 3 shows the expansion element 50 in the unexpanded state.
  • the unit comprising the lock 10 and the connecting section may have to withstand relatively large bending forces when reversing, as will be described later, it is advantageous to manufacture at least the connecting section 42 from a material of high rigidity, for example from metal. This also has the advantage of good visibility in an X-ray monitor.
  • a small metal element on the balloon, preferably at its front end.
  • it is preferably located on the inside of the balloon.
  • the actuating element 60 is either directly or via an intermediate piece, for example in the form of a hose, with the connecting element 40. In the latter case, this intermediate piece also belongs to the reel element 30.
  • the connecting element 40 is hollow throughout, so that liquid can be pressed by the actuating element 60 into the expansion element 50 designed as a balloon and pulled out of it again.
  • This connection can be interrupted by means of a shut-off valve which is arranged in the connection section 46.
  • the actuating lever 48 of this check valve is shown in the state “open” in FIG. 3.
  • the length of the connecting section 42 corresponds essentially to the total length of the lock 10 and the outer diameter of the connecting section 42 is somewhat smaller than the inner diameter of the front section 12 of the lock 10. This means that the connecting section 42 from the second end 10b of the lock 10 can be inserted into it until the stop 44 of the connecting element 40 bears against the second end 10b of the lock. In this state, the front end 42a of the connecting section 42 and thus also the (initially unexpanded) expansion element 50 - here the balloon - Arranged essentially flush at the first end 10a of the lock 10.
  • the expansion element (balloon) 50 can be brought into an expanded state.
  • the shut-off valve can be closed (FIG. 4).
  • FIG. 5 shows an initial state in which the first end 10a of the sluice 10 is located in a blood vessel B, in particular a main artery in the groin.
  • the lock 10 points in one direction, either in Towards the heart or towards a leg.
  • the lock 10 is “empty”, that is to say there is neither a soul 20 nor a wire in it.
  • the actuating element 60 is actuated so that the expansion element 50 reaches its expanded state.
  • the check valve is then guided into its ' closed position by means of the lever 48.
  • the orientation of the lock can now be reversed, wherein, as mentioned, the expanded expansion element 50 serves as a kind of bearing point.
  • the shut-off valve is opened again by means of the lever 48 and the saline solution is withdrawn from the balloon-shaped expansion element 50 by means of the syringe (see FIG. 13 in this regard).
  • FIG. 14 shows that the core 20 extends through the lock 10 again.
  • a contrast medium can be used to fill the balloon. Since both the balloon and the positioning element are filled with liquid - here with the liquid contrast agent - during rotation, very good monitoring of the rotation process is possible in this case by means of a suitable imaging method, in particular by means of X-ray.
  • parts of the "pivot bearing" can consist of metal, as has already been mentioned.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Appareil médical doté d'un sas s'étendant d'une première terminaison à une deuxième terminaison, qui présente une ouverture de passage s'étendant entre ces deux terminaisons et qui peut être introduit de telle façon dans un vaisseau sanguin (B) d'un homme ou d'un animal, que sa première terminaison se trouve dans le vaisseau sanguin (B) et sa deuxième terminaison se trouve à l'extérieur de l'homme ou de l'animal, et d'un élément auxiliaire, qui présente un élément de liaison présentant une terminaison avant et un élément d'expansion disposé au niveau de l'élément de liaison dans la zone de la terminaison avant de l'élément de liaison, de telle façon que l'élément d'expansion est déplaçable dans son état non expansé à travers l'ouverture de passage du sas avec la terminaison avant de l'élément de liaison à partir de la deuxième terminaison du sas, de sorte que l'élément d'expansion prend alors sa position d'utilisation et peut-être amené dans cette position d'utilisation dans un état expansé ou prend automatiquement un état expansé, l'élément de liaison présentant un agent de positionnement par rapport au sas, de sorte que lorsque l'agent de positionnement prend une position définie par rapport au sas et que l'élément d'expansion est expansé, l'élément d'expansion se raccorde à la première terminaison du sas, pour former ainsi un corps de palier rotatif disposé dans le vaisseau sanguin (B) pour le pivotement du sas.
PCT/EP2019/080196 2018-11-07 2019-11-05 Appareil médical, élément auxiliaire pour une utilisation en tant que partie d'un tel appareil médical et d'un élément de liaison pour une utilisation en tant que partie d'un tel élément auxiliaire Ceased WO2020094620A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
DE112019005561.5T DE112019005561A5 (de) 2018-11-07 2019-11-05 Medizinisches gerät, hilfselement zur verwendung als teil eines solchen medizinischen gerätes und verbindungselements zur verwendung als teil eines solchen hilfselementes

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE202018106333 2018-11-07
DE202018106333.2 2018-11-07
DE202018107159.9U DE202018107159U1 (de) 2018-11-07 2018-12-14 Medizinisches Gerät, Hilfselement zur Verwendung als Teil eines solchen medizinischen Gerätes und Verbindungselement zur Verwendung als Teil eines solchen Hilfselementes
DE202018107159.9 2018-12-14

Publications (1)

Publication Number Publication Date
WO2020094620A1 true WO2020094620A1 (fr) 2020-05-14

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Family Applications (1)

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PCT/EP2019/080196 Ceased WO2020094620A1 (fr) 2018-11-07 2019-11-05 Appareil médical, élément auxiliaire pour une utilisation en tant que partie d'un tel appareil médical et d'un élément de liaison pour une utilisation en tant que partie d'un tel élément auxiliaire

Country Status (2)

Country Link
DE (2) DE202018107159U1 (fr)
WO (1) WO2020094620A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5728134A (en) * 1996-09-17 1998-03-17 Barak; Shlomo Method and apparatus for hemostasis
US20020133123A1 (en) * 2001-03-14 2002-09-19 Cardiodex Balloon method and apparatus for vascular closure following arterial catheterization
EP1598016A2 (fr) * 1995-06-07 2005-11-23 Datascope Investment Corp. Fil-guide à barbe d'ancrage amovible
US20070021770A1 (en) * 1995-09-15 2007-01-25 Boston Scientific Scimed, Inc. Apparatus and Method for Percutaneous Sealing of Blood Vessel Punctures
US20090054926A1 (en) * 2007-08-21 2009-02-26 St. Jude Medical Puerto Rico B.V. Extra-vascular sealing device and method
CN107530532A (zh) * 2015-02-04 2018-01-02 斯瑞克欧洲控股有限责任公司 用于在患者的体内的管中实施治疗的装置和方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE7339606U (de) * 1974-01-31 Durst Ag Endoskop zur Untersuchung und Behandlung von Harnröhrenstrikturen
US4798586A (en) * 1987-04-09 1989-01-17 Cordis Corporation Method and apparatus for aiding dilatation catheterization
US5395349A (en) * 1991-12-13 1995-03-07 Endovascular Technologies, Inc. Dual valve reinforced sheath and method
US20140018732A1 (en) * 2011-01-10 2014-01-16 Spotlight Technology Partners Llc Apparatus and Methods for Accessing and Treating a Body Cavity, Lumen, or Ostium
US8956376B2 (en) * 2011-06-30 2015-02-17 The Spectranetics Corporation Reentry catheter and method thereof

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1598016A2 (fr) * 1995-06-07 2005-11-23 Datascope Investment Corp. Fil-guide à barbe d'ancrage amovible
US20070021770A1 (en) * 1995-09-15 2007-01-25 Boston Scientific Scimed, Inc. Apparatus and Method for Percutaneous Sealing of Blood Vessel Punctures
US5728134A (en) * 1996-09-17 1998-03-17 Barak; Shlomo Method and apparatus for hemostasis
US20020133123A1 (en) * 2001-03-14 2002-09-19 Cardiodex Balloon method and apparatus for vascular closure following arterial catheterization
US20090054926A1 (en) * 2007-08-21 2009-02-26 St. Jude Medical Puerto Rico B.V. Extra-vascular sealing device and method
CN107530532A (zh) * 2015-02-04 2018-01-02 斯瑞克欧洲控股有限责任公司 用于在患者的体内的管中实施治疗的装置和方法

Also Published As

Publication number Publication date
DE112019005561A5 (de) 2021-07-29
DE202018107159U1 (de) 2020-02-12

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