WO2006032290A2 - Systeme d'introduction pour implants - Google Patents

Systeme d'introduction pour implants Download PDF

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Publication number
WO2006032290A2
WO2006032290A2 PCT/EP2004/010611 EP2004010611W WO2006032290A2 WO 2006032290 A2 WO2006032290 A2 WO 2006032290A2 EP 2004010611 W EP2004010611 W EP 2004010611W WO 2006032290 A2 WO2006032290 A2 WO 2006032290A2
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
storage container
insertion device
implant
combination according
Prior art date
Application number
PCT/EP2004/010611
Other languages
German (de)
English (en)
Other versions
WO2006032290A3 (fr
Inventor
Achim Flesser
Ralph Bodenburg
Ronald Kontek
Original Assignee
Dendron 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 Dendron Gmbh filed Critical Dendron Gmbh
Priority to PCT/EP2004/010611 priority Critical patent/WO2006032290A2/fr
Publication of WO2006032290A2 publication Critical patent/WO2006032290A2/fr
Publication of WO2006032290A3 publication Critical patent/WO2006032290A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/958—Inflatable balloons for placing stents or stent-grafts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/9522—Means for mounting a stent or stent-graft onto or into a placement instrument

Definitions

  • the invention relates to a system for placing a medical implant in the body of a patient with a storage container, comprising an internally hollow tube for receiving the implant in the storage state, which can be passed through a catheter for introduction into the blood vessel system of the patient to its destination.
  • vascular constrictions stenoses
  • stents vascular endoprostheses, vascular stents
  • Gefäßwandaussackacks aneurysms
  • fistulas fistulas
  • balloon-sterilizable stents have been used.
  • self-expanding stents have proven that are made of shape memory materials. These have a grid or mesh structure and are first passed in the collapsed state through a catheter to the destination, where they widen due to the change in temperature (thermal shape memory effect) or by the elimination of the force exerted by the catheter mechanical (superelasticity).
  • the stent made of a shape memory material should initially be present as an elongated, highly compressed filament and only when it exits the catheter through
  • bearing tubes of the prior art are usually made of a comparatively soft material, so that the mesh structure of the stent can be virtually reproduced on the bearing tube. Due to this sticking, it may be difficult to push the stent out of the storage tube, and often only after repeated pulling back and forth.
  • a combination for placing a medical implant in the body of a patient with a storage container having an internally hollow tube for receiving the implant in the storage state wherein the combination further comprises a catheter end, which when connected to a catheter for insertion in the blood vessel system of the patient forms the proximal end of the catheter, so that the implant can be passed through the catheter to its destination, and an insertion device having an internally hollow tube, wherein the insertion device at at least one end of the tube with both the Katheterend Vietnamese is detachably connectable with at least one end of the bearing device in such a way that the implant with the aid of a guide wire located proximally on the implant or other insertion aid when connecting the storage container with the insertion of the storage container i n the introducer and, when connecting the introducer with the Katheterend Cambodia, which is simultaneously connected to the catheter, can be transferred from the introducer into the catheter.
  • Such a combination offers the possibility of storing a medical implant, for example a stent, in the storage device and of introducing it into the proximal end region of a catheter in a simple manner.
  • the implant is first transferred from the storage container into the insertion device, before the catheter end piece with catheter is connected to the insertion device after removal of the storage container, in order to be able to introduce the implant into the catheter.
  • the combination according to the invention also offers the possibility of introducing a medical implant alone into the proximal end region of a catheter without the help of other persons, without taking an excessive risk of damaging the implant during insertion.
  • the introducer can be fixed in the catheter endpiece so that it no longer moves in the axial direction in the catheter endpiece.
  • the storage container is delivered in a mold connected to the introducer, wherein in the storage container, the medical implant is located and located at the proximal end of the implant Guidewire extends through the inside hollow tube of the introducer.
  • This compilation can be packaged sterile and stored for a longer period of time.
  • the catheter end piece also belonging to the combination according to the invention is characterized in that it has a possibility for producing a releasable connection with the insertion device and at the same time can be connected to a catheter.
  • the catheter tip When the catheter tip is connected to the catheter, it forms the proximal end of the catheter.
  • This connection may be permanent, such that the catheter tip is part of the catheter itself, or temporarily.
  • the catheter end piece serves as an adapter for a catheter for the insertion device according to the invention.
  • a catheter which is permanently connected to the catheter end has the advantage that it is precisely matched to the combination according to the invention and can be used correspondingly directly.
  • Such a catheter may be supplied directly for use as part of the combination of the invention.
  • the connection to an additional catheter end piece is not necessary in this case, since this is already part of the catheter itself.
  • the catheter tails are adapters that can be connected to a commercially available catheter to form the proximal end of the catheter. This makes it possible to manufacture catheter end pieces so that they are adapted on the one hand for use with a particular catheter and on the other hand can be used as part of the combination according to the invention.
  • the adapters are conveniently provided with a label that provides information about which catheter they are used.
  • proximal and distal are understood to mean that “distal” refers to the orientation to the outside of the target organism, ie to the surgeon
  • occlusion helices serve the occlusion of body cavities or vessels such as arteries, veins, fallopian tubes or vascular malformations (eg vascular aneurysms).
  • occlusion coils are usually controlled with the aid of an endovascular guide wire in a catheter through the blood vessel system and advanced at the destination from the catheter into the cavity to be occluded and deposited there. Subsequently, the separation of the occlusion helix, which can be done in different ways. In particular, the process of electrolytic corrosion has proven itself.
  • the occlusion helix is transported with the aid of a proximally attached guidewire into the proximal end region of the catheter, where it is pushed out of the sheath.
  • This positioning is extremely difficult and can only be done in pairs.
  • the inner diameter of the storage container for receiving the implant is advantageous, it is advantageous to form the inner diameter of the storage container for receiving the implant larger than the inner diameter of the insertion device 5.
  • the larger inner diameter of the storage container must pass continuously into the smaller diameter of the insertion device, which can be done in various ways.
  • One possibility is to provide a portion in the hollow tube of the storage container in the direction of the end intended for connection to the insertion device, which tapers towards said end.
  • Another alternative or additional possibility is to conically form the transition from the storage container to the insertion device.
  • 25 storage container into the introducer is usually done by pulling on the proximal stent located on the guide wire, while the transfer takes place in the proximal end of the catheter by advancing the guide wire.
  • a guidewire instead of an ordinary guidewire other, essentially identical purposes serving insertion aids
  • Compression of the stent by pulling on the proximally attached guidewire is also advantageous in that it virtually eliminates the occurrence of bends during compression. This is due to the fact that the stent is the first in the proximal, with the guide wire connected area is compressed, where the stent is held under tension while pulling and therefore can not deviate from the target direction. In contrast, compressing the stent during advancement would risk bending or twisting of the stent in the initially compressed distal region, which is not secured by a guidewire.
  • the occlusion helixes may also be advantageous in the area of the occlusion helixes to make the inner diameter of the storage container larger than the inner diameter of the insertion device, since more and more occlusion helices are used, which are provided for the formation of a superordinate secondary structure in the aneurysm, which forces them after eliminating a constraint exerted by the catheter assume by itself. In such Okissesionschtln it may be useful to keep them in at least partially relaxed state in the storage container and only shortly before use to compress so that they can be passed through the catheter.
  • the implant Since the implant is received at the same end of the introducer of the storage container, where it is later delivered via the Katheterend Suite to the catheter, and the transition from the introducer into the Katheterend Stahl must be designed so that on the one hand the transfer by advancing the Guidewire is easily possible and on the other hand, the stent after introduction into the catheter has its intended compressed shape. To ensure this, the inner diameter of the catheter tip and the catheter should not be larger than the inner diameter of the introducer. In this way it is also ensured that the entire catheter lumen can be utilized for the implant. An additional enclosure around the implant, in particular the stent in order to keep it in a compressed form, is thus no longer necessary. By dispensing with an additional enclosure, the diameter of the catheter itself can be kept smaller, which is especially in the introduction of the catheter in particularly unelumige
  • Vessels is advantageous.
  • the preparation of the detachable connection between the introduction device and the storage container or catheter end piece can be produced in various ways familiar to the person skilled in the art. In particular, offers a plug and / or screw connection.
  • a connector can be made by 5 matched elements, for example by conical connectors and matched recordings.
  • Luer system is a standardized conical connection, in which a slightly conical connector is inserted into a designated lo recess in the counterpart.
  • a screwing system is often additionally used, which is called the Luer-Lock principle.
  • the male connection piece additionally has an internal thread, so that after being placed on the female connection piece, an i5 locking takes place by turning.
  • a luer-lock system is well known to those skilled in the field of medical technology, for example in the field of syringes and cannulas.
  • the introducer may have a male luer-lock connector while the catheter end and storage containers are provided with corresponding female luer connector counterparts.
  • Another possibility for producing the compounds is to provide the introducer with a conical element that can be inserted into a corresponding receptacle in the storage container and / or Katheterend published that a non-positive and / or positive connection is brought about. The positive engagement is thereby through each other
  • the surgeon only leaves the introducer in communication with the proximal end of the catheter at the beginning of the procedure and removes it after overcoming about half the way to the medical implant placement site.
  • the invention also contemplates the storage container, introducer and catheter endpiece for use as part of a combination as described above and a catheter permanently attached to such a catheter endpiece.
  • the invention is intended primarily for use in the treatment of humans but may well be applied to animals.
  • FIG. 1 shows a storage container according to the invention in cross section
  • Figure 1a shows an alternative embodiment of a storage container according to the invention in cross section
  • Figure 2 shows an insertion device according to the invention in cross section
  • Figure 2a shows an alternative embodiment of an insertion device according to the invention in cross section
  • Figure 3 shows a storage container according to the invention, which is connected to an insertion device according to the invention, in cross-section and the transfer of a stent from the storage container into the insertion device;
  • FIG. 4 shows a catheter end piece according to the invention, which is connected to an insertion device according to the invention, in cross section and the transfer of a compressed stent from the insertion device into the catheter end piece and
  • FIG. 5 shows an alternative catheter end piece according to the invention, which is provided with an alternative inventive
  • Insertion device is connected, in cross-section and the transfer of a compressed stent from the introducer into the
  • the storage container 1 of Fig. 1 consists primarily of a hollow tube 2 inside, which has a tapered transition 3 at the provided for the connection with the insertion device side, within which the inner diameter of the storage container 1 is significantly reduced.
  • An implant located in the storage container 1 is correspondingly compressed in its cross section when passing through the transition 3 and brought to a diameter as it is suitable for insertion into the insertion device.
  • the stent which usually has a grid or mesh structure, is stretched.
  • the Luer connector 4 On its outer side, the Luer connector 4 has a thread, so that a lock can be made when connected to a corresponding Luer-Lock connector.
  • the storage container 1 also includes gripping pieces 5, which improve the handling of the storage container 1.
  • an insertion device 6 is shown in cross section, which can be used in combination with the storage container 1 of FIG.
  • the insertion device also has an inside hollow tube 7, which serves to receive the stent in a compressed form.
  • the insertion device 6 comprises at its intended for connection to the storage container 1 end a Luer-lock connector 8, which serves the connection with the corresponding counterpart 4 of the storage container 1 and the Katheterend Cultures and is fixable by locking by means of the screw system ,
  • the insertion device 6 includes additional grips 9, which additionally improve the handling.
  • FIG. 1a an alternative embodiment of a storage container 1 is shown, which can be connected via a plug connection with the insertion device 6 of Fig. 2a.
  • the storage container 1 at its intended for connection to the insertion device 6 end a straight portion 13 into which a matching connector 12 of the insertion device 6 can be inserted.
  • Fig. 2a shows the corresponding insertion device 6 for the storage container 1 of Fig. 1a.
  • This has an elongated portion 12 which can be inserted into a designated recess 13 of the storage container 1, to connect the two parts together.
  • the insertion device 6 also has a union nut 8 in the manner of a Luer lock connection piece, which serves for fixing with the counterpart 4 of the storage container 1.
  • the elongate portion 12 may also be a tube which is fixedly connected to the insertion device 6.
  • plug connection does not have to be straight, as shown here, but may also have a cone shape.
  • FIG. 3 the connection of storage container 1 and insertion device 6 is shown.
  • an implant 14 in particular a stent, is located in the storage container 1, to which a guide wire 15 is attached in the proximal region.
  • This guide wire 15 extends through the lumen of the storage container 1 and the insertion device 6, so that the surgeon can pull the implant 14 by means of the guide wire 15 in the direction of the arrow 16 from the storage container 1 into the insertion device 6.
  • the implant 14 must pass the tapered portion 3, whereby the inner surfaces of the storage container 1 exert a corresponding force on the implant 14, which converts this into a compressed, elongated shape.
  • the implant 14 has a cross-section which is suitable for insertion into the insertion device 6 and ultimately also the catheter and essentially corresponds to the inner diameter of the insertion device 6.
  • FIG. 4 shows the transfer of the implant 14 from the insertion device 6 into the catheter end piece 17.
  • Catheter end piece 17 and insertion device 6 are in turn connected to each other by a luer lock connection system.
  • the compressed stent 14 is pushed by means of the proximally mounted guide wire 15 in the direction of the arrow 18 from the insertion device 6 into the catheter end piece 17.
  • the inner diameter of the inside hollow tube 7 of the introducer 6 is in line with the inner diameter of the Katheterend Swisslumens 19 so that the implant 14 no longer changes its cross section in the transfer.
  • the catheter tip 17 may be connected to a catheter (not shown) in the form of an adapter or may be an integral part of the catheter.
  • FIG. 5 shows the transfer of the implant 14 from the insertion device 6 into the catheter end piece 17 according to an alternative embodiment Embodiment shown.
  • the insertion device 6 has a conical element 10, which is suitable in a corresponding receptacle 20 in the catheter end piece 17.
  • the inner diameter of the inside hollow tube 7 of the insertion device 6 coincides with the inner diameter of the Katheterend Swisslumens 19.
  • the connection between the insertion device 6 and catheter end piece 17 is ensured by force and positive engagement. It makes sense that the storage container 1 should also have a recess corresponding to the receptacle 20.
  • the handling of this embodiment corresponds to that of FIG. 4th

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une combinaison permettant le positionnement d'implants médicaux (14) dans le corps d'un patient. Cette combinaison comprend un récipient de stockage (1) destiné à recevoir l'implant (14) en l'état stocké, une pièce d'extrémité de cathéter (17) formant, par liaison avec un cathéter, l'extrémité proximale du cathéter, et un dispositif d'introduction (6). Le dispositif d'introduction (6) peut être connecté amovible, aussi bien avec la pièce d'extrémité de cathéter (17), qu'avec le dispositif de stockage (1), de telle façon que l'implant (14) soit transférable, à l'aide d'un fil métallique de guidage (15) situé proximal sur l'implant (14), du récipient de stockage (1), dans le dispositif d'introduction (6) et, de ce dernier (6), dans le cathéter. La combinaison selon l'invention simplifie la manipulation lors de l'introduction d'un implant (14) dans un cathéter. En outre, un implant (14), en particulier un stent, peut être conservé pendant de plus longues périodes de temps, en un état de détente, sans compression, dans ledit récipient de stockage (1), si le diamètre intérieur du récipient de stockage (1) est plus grand que le diamètre intérieur du dispositif d'introduction (6) et que la lumière du cathéter.
PCT/EP2004/010611 2004-09-22 2004-09-22 Systeme d'introduction pour implants WO2006032290A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2004/010611 WO2006032290A2 (fr) 2004-09-22 2004-09-22 Systeme d'introduction pour implants

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2004/010611 WO2006032290A2 (fr) 2004-09-22 2004-09-22 Systeme d'introduction pour implants

Publications (2)

Publication Number Publication Date
WO2006032290A2 true WO2006032290A2 (fr) 2006-03-30
WO2006032290A3 WO2006032290A3 (fr) 2009-03-05

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Family Applications (1)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5676671A (en) * 1995-04-12 1997-10-14 Inoue; Kanji Device for introducing an appliance to be implanted into a catheter
US5725519A (en) * 1996-09-30 1998-03-10 Medtronic Instent Israel Ltd. Stent loading device for a balloon catheter
US6068635A (en) * 1998-03-04 2000-05-30 Schneider (Usa) Inc Device for introducing an endoprosthesis into a catheter shaft
US6090035A (en) * 1999-03-19 2000-07-18 Isostent, Inc. Stent loading assembly for a self-expanding stent
WO2000062711A1 (fr) * 1999-04-15 2000-10-26 Smart Therapeutics, Inc. Stent intravasculaire et procede de traitement de lesion d'un vaisseau neurovasculaire
US20030225445A1 (en) * 2002-05-14 2003-12-04 Derus Patricia M. Surgical stent delivery devices and methods

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5676671A (en) * 1995-04-12 1997-10-14 Inoue; Kanji Device for introducing an appliance to be implanted into a catheter
US5725519A (en) * 1996-09-30 1998-03-10 Medtronic Instent Israel Ltd. Stent loading device for a balloon catheter
US6068635A (en) * 1998-03-04 2000-05-30 Schneider (Usa) Inc Device for introducing an endoprosthesis into a catheter shaft
US6090035A (en) * 1999-03-19 2000-07-18 Isostent, Inc. Stent loading assembly for a self-expanding stent
WO2000062711A1 (fr) * 1999-04-15 2000-10-26 Smart Therapeutics, Inc. Stent intravasculaire et procede de traitement de lesion d'un vaisseau neurovasculaire
US20030225445A1 (en) * 2002-05-14 2003-12-04 Derus Patricia M. Surgical stent delivery devices and methods

Also Published As

Publication number Publication date
WO2006032290A3 (fr) 2009-03-05

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