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WO2008014849A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

Info

Publication number
WO2008014849A1
WO2008014849A1 PCT/EP2007/005499 EP2007005499W WO2008014849A1 WO 2008014849 A1 WO2008014849 A1 WO 2008014849A1 EP 2007005499 W EP2007005499 W EP 2007005499W WO 2008014849 A1 WO2008014849 A1 WO 2008014849A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
steel part
steel
nitinolteil
connecting sleeve
Prior art date
Application number
PCT/EP2007/005499
Other languages
German (de)
English (en)
Inventor
Peter Osypka
Original Assignee
Peter Osypka
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 Peter Osypka filed Critical Peter Osypka
Priority to EP07726125A priority Critical patent/EP2046205A1/fr
Publication of WO2008014849A1 publication Critical patent/WO2008014849A1/fr

Links

Classifications

    • 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
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00526—Methods of manufacturing
    • 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
    • A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
    • 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
    • A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00592—Elastic or resilient implements
    • 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
    • A61B2017/00575—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 for closure at remote site, e.g. closing atrial septum defects
    • A61B2017/00606—Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect

Definitions

  • the invention relates to a medical device such as Biop- er cannula or ASD closure with at least one made of steel or iron and connected thereto in the position of use, consisting of Nitinol part.
  • a part made of steel for example a tube of a biopsy cannula or device with a Nitinolteil, for example, an easily bendable end of such Biop- er cannula or The same or an existing Nitinol ASD closure with a Zu Norwaykatheder steel or iron or a corresponding alloy, although steel or iron and nitinol can not be welded together.
  • the steel part can be connected to the sleeve either in one piece or by welding or also by positive engagement, while this sleeve can be mechanically and / or positively connected to the nitmol part, which does not permit welding.
  • the steel part and the nitro moiety can thus be designed as continuous tube pieces, for example for forming a cannula, and touch each other at their front ends, and the one part can have at least one recess forming a hermetic intersection and the other part can fit into this recess, have axially projecting projection.
  • the two tubular or sleeve-like parts can fit together in the axial direction and thereby be permanently connected by the overlapping sleeve.
  • At least one overlapping connecting sleeve is arranged on the outside on one of the parts to be connected or on the outside on both parts to be joined.
  • the junction is protected by this overlapping connection sleeve against external mechanical effects, so that the risk that a projection is deflected from a recess, is almost impossible.
  • the steel part and the Nitinolteil in the connection region and the connecting sleeve have a circular cross-section.
  • Such a cross section is particularly easy to handle and requires no special orientation in the direction of rotation for the overlapping sleeve. This could possibly be appropriate and necessary if at the same time in the connection area Rotational security for this overlapping sleeve would be provided relative to the parts to be joined.
  • connection sleeve can at least in some areas have touch contact and / or a sliding or clamping seat with at least one of the parts to be connected or with both parts in the position of use. Accordingly, it can be arranged on the outside or on the inside of the parts to be joined and welded to the steel part, for example.
  • a particularly favorable definition of the overlapping connection sleeve in the connection region in the axial and in the rotational direction can provide that the overlapping connection sleeve and the Nitinolteil in the common overlap region in each case least one transversely or perpendicular to the sleeve center or sleeve axis arranged, extending through both parts at least partially or continuing opening or perforation or bore, in which a sleeve engages the Nitinolteil at least over a portion of the extension of the openings or holes or holes passing projection or pin or rivet, which produces positive connection with the connecting sleeve.
  • connection point can make a positive connection with the nitinol part via the connection sleeve, so that projections engaging in a recess in the axial direction can be assisted or even possibly avoided.
  • Such an arrangement is also particularly useful in the connection of an ASD closure with a steel sleeve part to which a Ein 1500katheder example, can be screwed axially.
  • the opening or perforation or bore in the overlap region and the projection or pin or rivet engaging therein can expediently extend radially to the connection sleeve. Accordingly easy is the attachment of both the hole and the pin.
  • the overlapping part of the connecting sleeve and the steel part can be positively connected in the axial direction and in the rotational direction by means of at least one projection or pin or rivet passing through both parts.
  • a mechanical connection with the aid of a transverse pin or the like can also take place in order to be able to transmit higher forces.
  • the overlapping sleeve may be provided on the outside and / or inside of the steel part and on the nitinol part, and the projection or pins or rivets may pass through the steel part or the nitinol part and all connection sleeves at least over part of the wall thickness.
  • a sleeve overlapping on the outside has a larger cross-section in the overlapping area than the part encompassed by it. At the same time it could overlap the other parts on the inside, if this in turn would have a larger cross-section.
  • both parts to be joined will have matching cross sections, so that the overlapping sleeve either engages on the outside over both parts or engages on the inside in both parts.
  • a sleeve on the outside and a second sleeve on the inside in the connection region, these overlapping could be provided in order to reinforce the mutual connection even better.
  • connection sleeve arranged on the outside can be radially inwards relative to areas adjacent thereto deformed or contracted and the connection sleeve can fill the extent of this collection completely or at least partially.
  • the outside of the connection sleeve may have the same external cross section as the steel part and / or the nitinol part adjacent to the joint and its neck.
  • At least one of the connecting sleeves can be made of steel, so that their welding to the steel part is particularly simple.
  • such a steel sleeve has a high strength, so that the rivet connection with the Nitinolteil is correspondingly stable.
  • such a sleeve supports the axially engaging in a recess projections in the radial direction outwardly and / or inwardly against deformation, so that a total of high-strength connection between the two parts of steel on the one hand and Nitinol on the other can be formed, although these both parts can not be welded.
  • Fig. 1 A partially longitudinally held medical device, namely a cannula, in particular a biopsy cannula, the tip of which consists of Nitinol and with a tube made of steel or iron or weldable
  • Metal is mechanically and positively connected at the joint joint, wherein the joint is overlapped on the outside by a connecting sleeve, which is welded to the tube,
  • Fig. 2 is a representation corresponding to Fig. 1 a modified embodiment in which the connecting sleeve in addition to the steel or metal tube riveted, wherein in addition an inner overlapping or supporting sleeve is provided for the connection area,
  • FIGS. 1 and 2 show a modified embodiment corresponding to FIGS. 1 and 2, in which the cannula tip and the tubular part butt together and the overlapping sleeve is also connected to the nitinol part by rivets, wherein an outer sleeve is provided for mutual connection, which is not only welded to the steel part, but additionally riveted,
  • FIG. 4 a further embodiment analogous to FIG. 2, wherein the cannula tip and the tubular metal or steel part are butt joined together and both parts are riveted to an outer and an inner connecting sleeve,
  • FIG. 5 shows an embodiment corresponding to FIG. 4, in which the connection region is deformed or drawn in radially inward so that the outer connection sleeve approximately corresponds in its outer diameter or outer cross section to that of the nitinol tip and the metal or steel part, as well as FIG
  • FIG. 6 shows a medical device as an ASD closure or occlusion device analogous to DE 103 38 702 B3, wherein a socket of this closure made of nitinol is connected to a sleeve-shaped steel part with a coaxial internal thread by riveting.
  • a socket of this closure made of nitinol is connected to a sleeve-shaped steel part with a coaxial internal thread by riveting.
  • a medical device can be a biopsy cannula according to FIGS. 1 to 5 and, according to FIG. 6, an ASD closure analogous to the occlusion device according to DE 103 38 702 B3.
  • these devices 1 each one consisting of steel or iron or other weldable metal part 2, hereinafter also referred to as “steel part”, and at least one of Nitinol existing part 3, hereinafter referred to as “Nitinolteil 3", said this Parts 2 and 3 are in the position of use, as shown in the embodiments, connected to each other, although Nitinol is not weldable, so it can not be easily welded to the "steel part" or Part 2.
  • connection point 4 of the steel part 2 and the Nitinolteils 3, tube or tube-shaped or as a nozzle or projection, also of solid material (Fig. 6) is formed.
  • connection point 4 at least one connecting sleeve 5 is provided, which covers or overlaps both the steel part 2 and the nitinol part 3.
  • the connecting sleeve 5 with the steel part 2 form fit, by screwing, by welding (Fig. 1 to 5) and / or by riveting (Fig. 2 to 5) or in one piece (Fig. 6) and in a manner to be described with the Nitinolteil 3 across, be mechanically and / or positively connected.
  • Figs. 1 and 2 it is shown that the steel part 2 and the Nitinolteil 3 itself positively connected to each other may be, so that the connection sleeve 5, the Nitinolteil 3 and the junction 4 only needs to overlap to produce a stable connection.
  • the steel part 2 and the Nitinolteil 3 are formed as a continuation of pipe sections, for example, to form a cannula or biopsy cannula.
  • the Nitinolteil 3 has at least one recess forming an undercut 6 and the other part, so the steel part 2 has a matching in this recess 6, axially projecting projection 7, of the recess 6 positively filling and produces positive engagement and tensile strength due to the undercuts 8 not only in the direction of rotation, but also in the axial direction.
  • both recesses 6 are arranged on the Nitinolteil 3, but also a reverse arrangement could be selected.
  • connection sleeve 5 overlaps this mutual connection and is fastened to the steel part 2 on one of the parts to be joined, in the exemplary embodiments according to FIGS. 1 and 2, and overlaps the connection point 4, so that the projection 7 is not radially deflected or moved bent outside and thereby can be moved out of the recess 6. Furthermore, thereby the projection 7 is protected against unwanted loading from the outside.
  • the steel part 2 and the Nitinolteil 3 at least in the connection region 4 as well as the connecting sleeve 5 has a circular cross-section.
  • connection point 4 is protected and reinforced.
  • the connecting sleeve 5 is only connected or welded to the steel part 2 by means of a weld 9 and according to FIG. 2 with them and the steel part 2 radially passing pins or rivets 10 is additionally connected, while the Nitinolteil 3 via the recess. 6 and the projection 7 is fixed thereto, it is provided in the embodiments according to FIGS.
  • connection sleeve 5 and the Nitinolteil 3 in the common overlap region in each case at least one or more circumferentially distributed, transversely or perpendicularly to the sleeve center or sleeve axis arranged, continuing openings or perforations or holes, in each of which the sleeve 5 and the Nitinolteil 3 by passing projection or pin or rivet 10 engages, which then produces between Nitinolteil 3 and connection sleeve 5 positive locking in the direction of rotation and especially in the axial direction, so that tensile strength is given.
  • FIG. 3 shows an arrangement in which the connecting sleeve 5 is both welded to the steel part 2 and connected via such rivets 10 and additionally riveted in accordance with the Nitinol part 3. If necessary, it would be possible for the pins or rivets 10 to be located in the region of the steel part 2. Because of the weld 9 also be waived. Conversely, with regard to the riveting with the steel part 2 could possibly be dispensed with the weld 9.
  • the openings or holes or holes in the overlap region and the engaging projection or pin or rivet 10 extend radially to the connecting sleeve 5, resulting in the simplest production.
  • the steel part 2 and the Nitinolteil 3 itself positively connected by means of the recess 6 and the projection 7 engaging therein and the connection point 4 is overlapped by the sleeve 4, which welded to the steel part 2 and / or by means Pins or rivets 10 may be connected in the embodiment of FIGS. 3 to 6 by the overlapping sleeve 5 and the Nitinolteil 3 by means of pins or rivets 10, while the sleeve 5 also connected to the steel part 2 in the ways already described can be.
  • the overlapping sleeve 5 can, as shown in allPolsbei- play, be provided on the outside of the steel part 2 and the Nitinolteil 3, but can also be provided on the inside or both outside and inside, according to Figures 2, 4 and 5, so that in this According to FIGS. 2, 4 and 5 two overlapping sleeves 5 are provided.
  • the projections or pins or rivets 10 then pass through all connecting or overlapping sleeves 5 and of course also the parts 2 or 3 located therebetween.
  • connection sleeve 5 directly or indirectly connectable areas of the steel part 2 and the matching in cross-section with the steel part 2 Nitinolteils 3 opposite thereto adjacent areas deformed radially inwardly or contracted, wherein the connection sleeve 5 at least partially fills the extent of this collection or the outside of this connection sleeve 5 in this embodiment has the same outer cross section as the steel part 2 and the Nitinolteil 3 adjacent to the connection point 4 and the retracted area.
  • connection sleeve 5 the medical device 1 thus does not have an enlarged outer dimension in the region of the mutual connection of the steel part 2 with the nitinol part 3, as is the case in the exemplary embodiments according to FIGS.
  • an inner connecting sleeve 5 is also provided for reinforcing the mutual connection and fastening.
  • the connecting sleeves 5 are made of steel, which allows a correspondingly good strength and power transmission.
  • connecting sleeve 5 is integrally connected to the steel part 2 and in turn arranged radially Pins or rivets 10 is attached to a Nitinol existing neck as Nitinolteil 3.
  • Nitinolteil 3 On the steel part 2 can be seen coaxially an internal thread 11 to which a Zulitekatheder or the like can be releasably attached.
  • the medical device for example a biopsy cannula or also an ASD closure or the like, has at least one part 2 consisting of steel, iron or weldable metal and a part 3 which is connected to it in the position of use and consists of nitinol, Nitinol is not weldable.
  • the connection point 4 of the steel part 2 and / or the Nitinolteils 3 is Rhausen- or sleeve-shaped or formed as a nozzle or projection, in particular projection of solid material or as a hollow projection and at least one connection sleeve 5 is provided, which the junction 4 and thus both the Steel part 2 and the Nitinolteil 3 detected and / or overlapped.
  • the connecting sleeve 5 can be positively connected to the steel part 2, by screwing and / or by welding and / or riveting or in one piece and with the Nitinolteil 3 mechanically and / or positively.
  • the steel part 2 and the Nitinolteil 3 itself be positively connected to each other.
  • the mutual connection can also be made additionally or exclusively via the connecting sleeve 5.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Insertion Pins And Rivets (AREA)

Abstract

L'invention concerne un dispositif médical (1), par exemple une canule à biopsie ou encore un obturateur de communication interauriculaire (CIA) ou similaire, comprenant au moins une pièce (2) en acier, en fer ou en métal soudable et une pièce (3) en nitinol, reliée à cette dernière en position d'utilisation, le nitinol n'étant pas soudable. Le point d'assemblage (4) de la pièce en acier (2) et/ou de la pièce en nitinol (3) est réalisé en forme de tube ou de douille, ou comme tubulure ou saillie, en particulier comme saillie en matériau plein ou comme saillie creuse, et au moins une douille d'assemblage (5) saisit et/ou chevauche le point d'assemblage (4) et donc non seulement la pièce en acier (2) mais aussi la pièce en nitinol (3). La douille d'assemblage (5) peut être liée à la pièce en acier (2) par complémentarité de forme, par vissage et/ou par soudage et/ou par rivetage ou en une pièce, et à la pièce en nitinol par chevauchement mécanique et/ou par complémentarité de forme. La pièce en acier (2) et la pièce en nitinol (3) elles-mêmes peuvent être assemblées par complémentarité de formes. Toutefois la liaison réciproque peut aussi s'effectuer en plus ou exclusivement par l'intermédiaire de la douille d'assemblage (5).
PCT/EP2007/005499 2006-07-29 2007-06-22 Dispositif médical WO2008014849A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07726125A EP2046205A1 (fr) 2006-07-29 2007-06-22 Dispositif médical

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102006035191.6 2006-07-29
DE200610035191 DE102006035191B4 (de) 2006-07-29 2006-07-29 Medizinische Vorrichtung

Publications (1)

Publication Number Publication Date
WO2008014849A1 true WO2008014849A1 (fr) 2008-02-07

Family

ID=38616304

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2007/005499 WO2008014849A1 (fr) 2006-07-29 2007-06-22 Dispositif médical

Country Status (3)

Country Link
EP (1) EP2046205A1 (fr)
DE (1) DE102006035191B4 (fr)
WO (1) WO2008014849A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8487210B2 (en) 2010-06-11 2013-07-16 W. C. Hereaus GmbH Joined dissimilar materials and method
US8569625B2 (en) 2009-12-22 2013-10-29 W. C. Heraeus Gmbh Joined dissimilar materials
CN106456141A (zh) * 2014-06-04 2017-02-22 奥林巴斯株式会社 接合构造和活检针

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9539670B2 (en) * 2010-05-25 2017-01-10 Creganna-Tactx Medical Joint for tubular materials

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0383159A1 (fr) * 1989-02-14 1990-08-22 Advanced Cardiovascular Systems, Inc. Fil de guidage extensible pour de opérations vasculaires
US5109867A (en) * 1991-04-19 1992-05-05 Target Therapeutics Extendable guidewire assembly
WO1998008432A1 (fr) * 1996-08-27 1998-03-05 C.R. Bard, Inc. Fil de guidage medical de faible masse, apte a recevoir et a transmettre un couple de torsion
US5782776A (en) * 1994-05-11 1998-07-21 Schneider A.G. Guidewire attachment assembly
US20020049392A1 (en) * 2000-10-20 2002-04-25 Demello Richard M. Composite guidewire
EP1325763A2 (fr) * 1996-10-22 2003-07-09 Terumo Kabushiki Kaisha Fil de guidage
US20060006649A1 (en) * 2004-06-25 2006-01-12 Galdonik Jason A Medical device having mechanically interlocked segments

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10338702B9 (de) * 2003-08-22 2007-04-26 Occlutech Gmbh Occlusioninstrument
GB0400571D0 (en) * 2004-01-12 2004-02-11 Angiomed Gmbh & Co Implant
DE102005022423B3 (de) * 2005-05-14 2007-01-18 Osypka, Peter, Dr.-Ing. Vorrichtung zum Einbringen eines Gegenstandes im Inneren eines Blutgefässes oder des Herzens

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0383159A1 (fr) * 1989-02-14 1990-08-22 Advanced Cardiovascular Systems, Inc. Fil de guidage extensible pour de opérations vasculaires
US5109867A (en) * 1991-04-19 1992-05-05 Target Therapeutics Extendable guidewire assembly
US5782776A (en) * 1994-05-11 1998-07-21 Schneider A.G. Guidewire attachment assembly
WO1998008432A1 (fr) * 1996-08-27 1998-03-05 C.R. Bard, Inc. Fil de guidage medical de faible masse, apte a recevoir et a transmettre un couple de torsion
EP1325763A2 (fr) * 1996-10-22 2003-07-09 Terumo Kabushiki Kaisha Fil de guidage
US20020049392A1 (en) * 2000-10-20 2002-04-25 Demello Richard M. Composite guidewire
US20060006649A1 (en) * 2004-06-25 2006-01-12 Galdonik Jason A Medical device having mechanically interlocked segments

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8569625B2 (en) 2009-12-22 2013-10-29 W. C. Heraeus Gmbh Joined dissimilar materials
US8835799B2 (en) 2009-12-22 2014-09-16 Heraeus Precious Metals Gmbh & Co. Kg Method of joining dissimilar materials
US8487210B2 (en) 2010-06-11 2013-07-16 W. C. Hereaus GmbH Joined dissimilar materials and method
CN106456141A (zh) * 2014-06-04 2017-02-22 奥林巴斯株式会社 接合构造和活检针
CN106456141B (zh) * 2014-06-04 2019-12-27 奥林巴斯株式会社 接合构造和活检针

Also Published As

Publication number Publication date
DE102006035191B4 (de) 2009-05-14
EP2046205A1 (fr) 2009-04-15
DE102006035191A1 (de) 2008-01-31

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