WO2004052215A1 - Dispositif pour implanter des elements d'occlusion - Google Patents

Dispositif pour implanter des elements d'occlusion Download PDF

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Publication number
WO2004052215A1
WO2004052215A1 PCT/DE2003/003855 DE0303855W WO2004052215A1 WO 2004052215 A1 WO2004052215 A1 WO 2004052215A1 DE 0303855 W DE0303855 W DE 0303855W WO 2004052215 A1 WO2004052215 A1 WO 2004052215A1
Authority
WO
WIPO (PCT)
Prior art keywords
compression spring
helical compression
section
predetermined breaking
breaking point
Prior art date
Application number
PCT/DE2003/003855
Other languages
German (de)
English (en)
Inventor
Frank Czerwinski
Original Assignee
Qualimed Innovative Medizinprodukte Gmbh
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 Qualimed Innovative Medizinprodukte Gmbh filed Critical Qualimed Innovative Medizinprodukte Gmbh
Priority to AU2003294631A priority Critical patent/AU2003294631A1/en
Publication of WO2004052215A1 publication Critical patent/WO2004052215A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
    • A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
    • A61B17/12113—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel within an aneurysm
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
    • A61B17/1214—Coils or wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00477—Coupling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
    • A61B2017/1205—Introduction devices
    • A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
    • A61B2017/12063—Details concerning the detachment of the occluding device from the introduction device electrolytically detachable

Definitions

  • the invention relates to a device for implanting occlusion agents according to the features in the preamble of claim 1.
  • a catheter is inserted subcutaneously from the groin into the vascular system and the aneurysm is probed.
  • the aneurysm can be filled by applying embolization materials. This removes the hemodynamic pressure from the vessel wall in order to avoid the risk of an aneurysm rupture and associated brain bleeding.
  • Platinum micro coils are preferably used as occlusion agents for embolization in neuroradiology.
  • a particular problem in the context of these so-called micro-spirals is the separation of the occlusion means from the carrier system after their placement.
  • electrolytic EP 726 745 B1
  • mechanical DE 93 20 840 111 separation processes.
  • mechanical separation processes certain coupling elements are required, which are relatively complex to manufacture on the one hand and on the other hand where premature, unwanted decoupling of the occlusion agent can easily occur, which leads to incorrect positioning and, in the worst case, to brain embolism.
  • a possibly sharp-edged coupling element which can lead to injuries at the implantation site, can also remain at the distal end of the carrier system.
  • Electrolysis results from the application of a positive direct current between 0.5 mA and 2 mA.
  • the negatively charged electrode is connected with a needle and grounded to the patient.
  • the electrolytic separation takes place within a period of about 10 seconds and a few minutes, the actual separation being indicated by a sudden increase in the voltage to 3.5 to 7.0 volts. In practice, however, it has been shown that fluctuations occur in the detachment time and that the voltage does not necessarily increase suddenly, so that the disconnection cannot be reliably recognized by the surgeon in some cases.
  • EP 726 745 B1 discloses a device for implanting occlusion coils with a guide wire, which has a single, discrete, electrolytically separable sacrificial member, which is provided at the distal end of a core wire.
  • the distal end of the core wire tapers and is surrounded for stabilization by a helical spring which is permanently connected to the core wire at its proximal end and is supported on the occlusion means at its distal end.
  • the object of the invention is to provide a device for implanting occlusion means, in which the access of blood to the predetermined breaking point is improved through a helical compression spring surrounding the transition section.
  • the radial plane spanned by the predetermined breaking point lies in the first longitudinal section of the helical compression spring.
  • the helical compression spring is not designed uniformly over its entire length, but has at least one first length section in which the distance between two adjacent turns is greater than in a second length section.
  • the predetermined breaking point can be designed to be electrolytically corrodible according to the features of patent claim 2.
  • the predetermined breaking point from a biodegradable material.
  • the synthetically produced polymers based on glycol (PGA) and lactic acid (PLA) are particularly suitable as biodegradable materials.
  • Other biodegradable polymers are poly (epsilon-caprolactone), poly (beta-hydroxybutyrate), poly (p-dioxanone), polyanhydrides, polyester urethane and polyorthoesters.
  • Poly-L-lactide (PLLA), polyglycolide, poly-D, L-cactide (PDLLA) can also be used as a biodegradable material.
  • the predetermined breaking point can also be designed in such a way that the transition section, with the incorporation of a biodegradable material, is attached to the proximal end of the occlusion agent in a positive or non-positive manner, the biodegradable material functioning as a kind of adhesive that erodes when it comes into contact with blood and releases the transition section. If the spring force emanating from the helical compression spring overcomes the forces prevailing in the predetermined breaking point, the occlusion agent is separated from the transition section.
  • the occlusion agent is separated by a combination of two mechanisms: first, the predetermined breaking point is weakened by electrolytic corrosion, whereupon the occlusive agent is torn off from the distal end of the transition section by supplying mechanical energy, namely the spring force emanating from the helical compression spring, and then is pushed away.
  • Pushing away also has the advantage that the helical compression spring extends through the relief and preferably projects beyond the distal end of the transition section, so that the predetermined breaking point lies protected inside the helical compression spring. Due to this push effect, the usually very sharp predetermined breaking point does not pose a danger to the immediately adjacent vessel walls and can be removed safely from the implantation space by withdrawing the guide wire.
  • predetermined breaking point is weakened by blood entry
  • this can be glued predetermined breaking points, e.g. can be solved by supplying thermal energy.
  • Known detachment methods by supplying electricity, laser radiation or vibrations are also possible.
  • positively or non-positively designed predetermined breaking points are conceivable, which can be activated, for example, by activating so-called memory alloys, e.g. Nitinol, can be solved.
  • non-positive connections are provided in which, for example, a biocompatible polymer clamps the distal end of the transition section, the polymer releasing this end with the application of energy so that the occlusion agent can be separated under the influence of the spring force.
  • Another advantage of the invention is that by pushing the occlusion agent away from the predetermined breaking point, the occlusion agent is abruptly separated, so that in the event of an electrolytic weakening, the predetermined breaking point place the electrolytic separation as a significant voltage fluctuation registered by the surgeon, so that he has certainty about the completion of the separation process.
  • a first longitudinal section and the predetermined breaking point are arranged offset to one another in the axial direction.
  • This configuration can be advantageous if a plurality of first length sections are provided alternating with second length sections, so that a certain blood exchange can take place through the inside of the helical compression spring, blood entering and exiting through the first length sections with a larger winding spacing.
  • the distance between two adjacent turns in the sense of the invention relates exclusively to spring arrangements not bent or bent about their longitudinal axis, but to helical compression springs in their unloaded, elongated configuration.
  • the distal end of the helical compression spring is preferably designed such that the spring force can be applied to the occlusion means as axially as possible. In the case of a flat radial contact surface of the occlusion means, this can be achieved by reducing the slope on the outgoing turn of the helical compression spring, so that the spring axis is at right angles on the contact surface.
  • This final Section of the helical compression spring is not to be understood as a second longitudinal section in the sense of the invention, but merely as a functionally dependent support area in which the winding spacing can be reduced depending on the configuration of the connection body. Longitudinal sections in the sense of the invention lie between these end regions, which may be adapted to the connecting bodies.
  • the distance between two adjacent turns is measured according to the distance measured within the surface line of the helical compression spring.
  • the surface line of the helical compression spring used in the context of the invention can be continuous or discontinuous in its course, that is to say also have jumps, in particular when transitioning from a first length section to a second length section.
  • Helical compression springs with a continuous surface line can be, for example, conical, double-conical or barrel-shaped helical compression springs, which may have a cylindrical intermediate part.
  • the outside diameter of the helical compression spring in the first length section can at least partially deviate from the outside diameter of the second length section, that is to say it can be larger or smaller on a part or have a completely different course (claim 6).
  • the outer diameter of the helical compression spring is preferably in the order of 0.1 mm to 2 mm (claim 7).
  • the helical compression springs can have an inconsistent wire diameter which both changes continuously over the entire longitudinal extent of the helical compression spring and also fluctuates as a function of the length sections, as is the subject of patent claim 8.
  • inconsistent wire diameters different distances between adjacent turns can also result from the wire diameter itself, while the pitch or the pitch of the helical compression spring remains the same.
  • the helical compression spring is made of a non-circular wire.
  • the wire can have, for example, an oval or also angular cross section.
  • the cross section can be rectangular, with a flattened wire, particularly in the confined space, depending on the configuration, being able to exert higher spring forces than a round wire.
  • An advantageous diameter range for the wire, in particular the round wire, of the helical compression spring is between 10 ⁇ m and 0.5 mm (claim 10).
  • a particularly economical to produce helical compression spring is seen in the features of claim 11, according to which the first longitudinal section is formed by strain hardening of a metallic helical compression spring.
  • the helical compression spring according to the invention can be formed, for example, from a cylindrical helical compression spring of constant winding spacing or with a constant pitch, a first length section being elongated beyond the material-specific yield point, so that work hardening takes place.
  • the first longitudinal section of the helical compression spring consists of a different material than the second longitudinal section (claim 12). It is conceivable that the helical compression spring consists at least partially, that is to say in a first or second length section, of a non-electrolytically corrodible metal (claim 13).
  • At least partial areas or longitudinal sections of the helical compression spring can consist of an electrically non-conductive polymer (claim 15)
  • the helical compression spring can at least partially be designed to be X-ray visible (claim 16).
  • X-ray visible materials for the helical compression spring or suitable particles are embedded in the material of the helical compression spring or are part of an electrically insulating coating.
  • Figure 1 shows an aneurysm bag in cross section, in which an occlusion agent is inserted through a catheter
  • FIG. 2 shows a greatly enlarged illustration of the distal end of an endovascular guidewire to which an occlusion device is attached;
  • FIG 3 shows another embodiment of the device according to the invention as shown in Figure 2;
  • Figure 4 is a cylindrical helical compression spring with inconsistent wire diameter
  • Figure 5 shows a double-cone helical compression spring with inconsistent
  • Figure 6 shows a partial section of a further embodiment of a helical compression spring with a non-circular wire cross-section.
  • FIG. 1 shows a device 1 for implanting occlusion means 2.
  • the device 1 is guided in a catheter 3, which in this embodiment is introduced into the aneurysm 4.
  • the occlusion means 2 is a wire helix 5 which is introduced into the aneurysm 4 through the catheter 3.
  • the occlusion means 2 or the wire helix 5 is fastened with its proximal end to a guide wire which is pushed through the catheter 3.
  • FIG. 2 shows the distal end 6 of the guide wire 7 in a greatly enlarged illustration.
  • the guide wire can be surrounded with an insulating coating for electrical insulation or can be provided with a shrink tube.
  • the distal end 6 has a tapered, conically configured transition section 8, which is surrounded at its distal end by a helical compression spring 9.
  • the proximal end 10 of the helical compression spring 9 is firmly connected to the transition section 8, for example welded.
  • the distal end 11 of the helical compression spring 9 bears against the proximal end 12 of the occlusion means or the wire helix 5, the proximal end 12 being provided with an end cap 13 attached to the wire helix 5 to avoid vascular lesions after detachment from the guide wire 7.
  • the distal end 14 of the transition section 8 has a very small cross section. This distal end 14 of the transition section 8 functions as a predetermined breaking point 15.
  • the predetermined breaking point 15 can, for example, be designed to be electrolytically corrodible or consist of a biodegradable material.
  • the radial plane of the predetermined breaking point 15, denoted by R, is located in a first length section 16 of the helical compression spring 9.
  • This first distal length section 16 adjoins a proximal second length section 17 of the helical compression spring.
  • the first length section 16 and the second length section 17 differ by the different distances A1, A2 of two adjacent turns of the respective length sections 16, 17.
  • the predetermined breaking point 15 which is particularly important in the case of electrolytically corrodible predetermined breaking points or in the case of predetermined breaking points made of biodegradable materials.
  • the helical compression spring 9 arranged under tension between the guide wire 7 and the proximal end 12 of the occlusion means 2 pushes the occlusion means 2 away, so that the predetermined breaking point 15 lies completely inside the helical compression spring 9 and injuries to the vessel walls are avoided.
  • FIG. 3 differs from the embodiment shown in FIG. 2 in that a further first length section 18 is provided on the helical compression spring 19 used.
  • first length sections 16, 18 and second length sections 17, 20 alternate, so that the access of blood into the interior of the helical compression spring 19 is further improved.
  • the blood flow in the first length section 18 enters the interior of the helical compression spring 19, penetrates the annular space in the region of the second length section 17 and can thus flow to the predetermined breaking point 15 in the axial direction and exits again radially between the turns of the first length section 16 ,
  • FIG. 4 shows an embodiment of a cylindrical helical compression spring 21 with an inconsistent wire diameter.
  • the wire diameter D is smaller in the first length sections 22 than in the central area of the helical compression spring 21, this area forming the second length section 23. Because of the larger wire diameter D, the distance A2 between two adjacent turns in the second length section 22 is smaller than in the first length sections 22.
  • FIG. 5 shows a barrel-shaped helical compression spring 24 with an inconsistent wire diameter.
  • the wire diameter D increases from the ends of the helical compression spring 24 to the center.
  • the first longitudinal section 25 is not in the region of the ends of the helical compression spring 24, but in the central region, whereas the second longitudinal sections 26 are arranged at the ends.
  • the outer diameter AD1, AD2 is different in each radial plane, in particular it is larger in the first length sections 25 than in the second length sections 26.
  • the embodiment in FIG. 6 shows a helical compression spring 27 made of flat wire.
  • the helical compression spring 27 has a first length section 28 and a second length section 29. In the second length section 29, the distance A2 between two adjacent turns is smaller than the distance A1 between two adjacent turns of the first length section.
  • the longitudinal sections 28, 29 are made of different materials.
  • the wire cross section is out of round. In the second length section 29 the wire cross section is square, in the first length section 28 the wire cross section is rectangular and larger than in the second length section 29. Because of the different materials and different geometries, the spring properties of the individual length sections 28, 29 are different. In particular, the windings effective for the spring force lie in the first longitudinal section 28.

Abstract

L'invention concerne un dispositif pour implanter des éléments d'occlusion (2) au moyen d'un fil conducteur (7), dont l'extrémité distale (6) est pourvue d'une partie de transition (8) s'effilant, comportant un point de rupture nominal (15) et entourée d'un ressort cylindrique de pression (9). Ce ressort cylindrique de pression (9), qui est précontraint, appuie avec son extrémité proximale (10) au moins indirectement contre le fil conducteur (7) pour fractionner le point de rupture nominal (15) et avec son extrémité distale (11) au moins indirectement contre l'élément d'occlusion (5). Ledit ressort cylindrique de pression (9) comporte au moins une première partie longitudinale (16), dans laquelle l'intervalle (A1) entre deux spires voisines est supérieur à celui existant dans une deuxième partie longitudinale (17), afin de faciliter l'écoulement du sang vers le point de rupture nominal (15). Le point de rupture nominal (15) est de préférence sensible à la corrosion par électrolyse, ou bien il est en matériau biodégradable.
PCT/DE2003/003855 2002-12-07 2003-11-20 Dispositif pour implanter des elements d'occlusion WO2004052215A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2003294631A AU2003294631A1 (en) 2002-12-07 2003-11-20 Device for implanting occlusion means

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE10257219A DE10257219B3 (de) 2002-12-07 2002-12-07 Vorrichtung zur Implantation von Okklusionsmitteln
DE10257219.4 2002-12-07

Publications (1)

Publication Number Publication Date
WO2004052215A1 true WO2004052215A1 (fr) 2004-06-24

Family

ID=31984456

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/DE2003/003855 WO2004052215A1 (fr) 2002-12-07 2003-11-20 Dispositif pour implanter des elements d'occlusion

Country Status (3)

Country Link
AU (1) AU2003294631A1 (fr)
DE (2) DE10257219B3 (fr)
WO (1) WO2004052215A1 (fr)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060200190A1 (en) * 2005-03-02 2006-09-07 Lorenzo Juan A Embolic coil with twisted wire
US20070073334A1 (en) * 2005-09-29 2007-03-29 Kamal Ramzipoor Combined electrolytic and mechanical separation background
US8152839B2 (en) 2005-12-19 2012-04-10 Boston Scientific Scimed, Inc. Embolic coils
US8101197B2 (en) 2005-12-19 2012-01-24 Stryker Corporation Forming coils
WO2007073550A2 (fr) 2005-12-19 2007-06-28 Boston Scientific Limited Spirales emboliques
EP2674114A1 (fr) * 2012-06-11 2013-12-18 Acandis GmbH & Co. KG Implant pour obturer des anomalies vasculaires et méthode pour produire un tel implant

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993016650A1 (fr) * 1992-02-24 1993-09-02 Regents Of The University Of California Fil endovasculaire detachable electrolytiquement et servant a la formation de thrombus
WO1995012367A1 (fr) * 1993-11-03 1995-05-11 Target Therapeutics, Inc. Jointure separable par voie electrolytique, pour dispositifs emboliques endovasculaires
WO1998009570A1 (fr) * 1996-09-03 1998-03-12 William Cook Europe A/S Dispositif intravasculaire d'embolisation
US5916235A (en) * 1997-08-13 1999-06-29 The Regents Of The University Of California Apparatus and method for the use of detachable coils in vascular aneurysms and body cavities
US6468266B1 (en) * 1997-08-29 2002-10-22 Scimed Life Systems, Inc. Fast detaching electrically isolated implant

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5122136A (en) * 1990-03-13 1992-06-16 The Regents Of The University Of California Endovascular electrolytically detachable guidewire tip for the electroformation of thrombus in arteries, veins, aneurysms, vascular malformations and arteriovenous fistulas

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1993016650A1 (fr) * 1992-02-24 1993-09-02 Regents Of The University Of California Fil endovasculaire detachable electrolytiquement et servant a la formation de thrombus
WO1995012367A1 (fr) * 1993-11-03 1995-05-11 Target Therapeutics, Inc. Jointure separable par voie electrolytique, pour dispositifs emboliques endovasculaires
WO1998009570A1 (fr) * 1996-09-03 1998-03-12 William Cook Europe A/S Dispositif intravasculaire d'embolisation
US5916235A (en) * 1997-08-13 1999-06-29 The Regents Of The University Of California Apparatus and method for the use of detachable coils in vascular aneurysms and body cavities
US6468266B1 (en) * 1997-08-29 2002-10-22 Scimed Life Systems, Inc. Fast detaching electrically isolated implant

Also Published As

Publication number Publication date
DE20315980U1 (de) 2004-03-04
DE10257219B3 (de) 2004-06-03
AU2003294631A1 (en) 2004-06-30

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