EP4093303A1 - Valvulotome - Google Patents

Valvulotome

Info

Publication number
EP4093303A1
EP4093303A1 EP21705106.9A EP21705106A EP4093303A1 EP 4093303 A1 EP4093303 A1 EP 4093303A1 EP 21705106 A EP21705106 A EP 21705106A EP 4093303 A1 EP4093303 A1 EP 4093303A1
Authority
EP
European Patent Office
Prior art keywords
basket
valvulotome
cutting
catheter
struts
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.)
Pending
Application number
EP21705106.9A
Other languages
German (de)
French (fr)
Inventor
Heinz Schade
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.)
Andramed GmbH
Original Assignee
Andramed 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 Andramed GmbH filed Critical Andramed GmbH
Publication of EP4093303A1 publication Critical patent/EP4093303A1/en
Pending legal-status Critical Current

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
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B17/32075—Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39—Markers, e.g. radio-opaque or breast lesions markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22097—Valve removal in veins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/08—Accessories or related features not otherwise provided for
    • A61B2090/0801—Prevention of accidental cutting or pricking
    • A61B2090/08021—Prevention of accidental cutting or pricking of the patient or his organs

Definitions

  • the invention relates to a valvulotome with a catheter tube and an expandable basket with cutting elements, the catheter tube being suitable for receiving the expandable basket in the non-expanded state.
  • Venous valves are suitable for obstructing the flow of blood, which is undesirable in the case of coronary vessels that supply the heart muscle with arterial blood.
  • certain endogenous veins which are usually taken from the patient's thigh area, have to be prepared beforehand for bypasses.
  • Dissection usually takes place in the patient's body some time before the bypass operation, if there is enough time, so that the corresponding vessels have time to recover and heal.
  • valvulotomes To remove venous valves in a patient's body, so-called valvulotomes are used, ie endovascular instruments that are inserted into the corresponding vessel and “strip” the venous valves with the help of laterally arranged cutting blades. Such an intervention is usually carried out with the aid of a catheter, which is guided on the distal lower leg via the groin or another access point into the corresponding vessel of the patient, and through which a known valvulotome is then transferred to the place of use.
  • the cutting elements of the valvulotome remove the venous valves that are over a basket-like structure near the tip of the valvulotome is drawn into the catheter and removed from the patient's body with the catheter and the valvulotome.
  • Such a valvulotome is known, for example, from WO 96/33662 A1, which is guided over a cable, has a basket as a spacer element, and cutting tools that are located in a cutting head in front of the basket. An atraumatic tip is located distally.
  • This valvulotome is guided to the place of use through a catheter, but cannot be controlled by itself. In particular, this valvulotome cannot be combined with a guide wire that is used for control purposes.
  • the basket and cutting elements are separated from one another, but must work together.
  • the cutting elements are movably arranged in a cutting head and are pressed against the vessel wall with the aid of the basket, which consists of spring elements.
  • a valvulotome is known in which the cutting blades are located on an expandable cutting basket, the cutting basket representing the distal end of a tube guided in a catheter.
  • the cutting basket can be received in the catheter in the non-expanded state.
  • the valvulotome has an inner guide wire for control and positioning.
  • a cuff serves as a distal limitation of the cutting basket and facilitates expansion.
  • valvulotomes which essentially consist of a spring cage which has cutting elements.
  • a valvulotome from LeMaitre which has been introduced into practice, is also catheter-guided and has a basket made of several struts with cutting elements integrated into the struts. These valvulotomes cannot be guided independently either.
  • the object of the invention is to create a valvulotome that can be guided independently to the place of use.
  • the valvulotome should be controllable to such an extent that the stripping process can be controlled by the attending physician and individually adapted to the diameter and condition of the patient's vein.
  • the basket of the valvulotome should remain free of internal elements in order to create a large volume for tissue remnants.
  • a valvulotome of the type mentioned at the outset in which the basket is fixed at the distal end of a wire element that runs in the catheter tube and in which the basket has an atraumatic and flexible tip distally.
  • the cutting basket and the atraumatic tip are made from a tube by laser cutting.
  • the tip is hollow.
  • the valvulotome according to the invention is guided in a conventional catheter with which it also works together.
  • the catheter is introduced into the vessel of a patient in the usual way and is controlled by the attending physician in the usual way via the wire element.
  • the wire element is not a conventional guide wire for placing the valvulotome, since it ends distally with the cutting basket of the valvulotome, that is, it is not guided into and through the cutting basket. It is only used to move the cutting basket.
  • the cutting basket is expandable, ie it can be guided in the catheter in its non-expanded form and expands into its expanded form outside of the catheter. For this reason it consists of a spring material, in particular made of a shape memory material, for example nitinol, which allows the extent of the expansion to be specified. For use, the cutting basket with the wire element is pushed out of the catheter.
  • the wire element must have both a certain flexibility and rigidity. It is therefore preferably a braided wire strand made of fine steel wires, which has sufficient rigidity to push the cutting basket out of the catheter and to pull it back into the catheter after the venous valves have been stripped. Because the wire element does not extend into the basket, there is enough space to accommodate the cut-off venous valves and to pull them back into the catheter with the basket. This has proven to be problematic in valvulotomes in which a guide wire is passed through the cutting head.
  • the distal end of the cutting basket is provided with an atraumatic tip which is designed to be soft in order to avoid damage to the vessel wall.
  • a spiral shape has proven to be very advantageous, i. H. the atraumatic tip is at least partially in the form of a helical spring.
  • the spirals of such a helical shape can be connected by struts in the manner of a universal joint.
  • Such a design is readily possible when the basket with the tip is manufactured from a tube by laser cutting.
  • the cutting basket and tip are preferably made in one piece, in particular from a suitable tube made of a shape memory material by laser cutting.
  • the atraumatic tip can have several arcs distally, which contribute to the soft formation of the tip and its atraumatic character. Preferred are three or four arcs which are bent inwardly towards the longitudinal axis of the tip.
  • This is used to control the valvulotome when it is introduced into a vessel and to facilitate positioning.
  • the valvulotome according to the invention is with its basket in the catheter, ie the basket takes a stretched one in the catheter Shape. Once released from the catheter, the basket will expand. The atraumatic tip of the cutting basket protrudes from the catheter; this makes it easier to control the valvulotome in the vessel. Control is therefore not carried out via a guide wire.
  • the basket has several struts that support the cutting elements.
  • the basket preferably has three struts, each with one or two cutting elements.
  • the design with three struts has the advantage that the basket centers itself in the vessel. With two cutting elements per strut, the cutting elements are on opposite sides of the strut, but point with their cutting edges in the same direction.
  • the struts of the basket are brought together distally in the atraumatic tip.
  • the tip and basket can be glued or welded, but they are preferably made in one piece by laser welding from a tube, in particular a tube made of a shape memory material.
  • the cutting elements preferably have hook-shaped cutting noses which run in the plane of the struts. In particular, the cutting noses are flanked by recesses in the struts, so that their cutting surface, in particular a cutting arc, remains in the longitudinal course of the struts.
  • the venous valves are then held in the recess from the cutting edge, cut by pulling back the valvulotome and then get into the inside of the basket and are pulled into the catheter with the basket.
  • Two cutting elements per strut simplify stripping.
  • the wire element is movably arranged in the catheter so that the basket can be advanced, rotated and withdrawn, also several times, in order to free the selected vein section from the venous valves.
  • the valvulotome according to the invention can have conventional radiopaque marker elements, which can be arranged in particular in the region of the distal end of the catheter tube. It goes without saying that the valvulotome according to the invention can be present in different sizes, for example with a 5F catheter and a cutting basket cut from a 4F nitinol tube.
  • the wire element is, for example, a steel wire strand with a thickness of 0.85 mm. It goes without saying that the term “distal” used here denotes the end of the valvulotome, catheter or wire element facing away from the attending physician, the term “proximal” the end facing the attending physician.
  • FIG. 2 a planar representation of the basket with 3 cutting elements and a point
  • FIG. 3 a planar representation of the basket with 6 cutting elements and a point
  • Fig. 4 a universal joint-like design of the tip.
  • FIG. 1 shows an inventive valvulotome together with the introducer 1, the handle 2 for moving the wire element 3.
  • the valvulotome consists primarily of the catheter tube 4, the wire element 3, the cutting basket 5 and the atraumatic, soft tip 8.
  • the cutting basket 5 is extended from the catheter tube 4, expanded and ready for use in a vein for stripping the venous valves. It has three struts 6, each provided with a cutting element 7.
  • the cutting basket 5 itself is provided with an atraumatic and soft tip 8 proximally.
  • Cutting basket 5 and tip 8 are made of the same material and are made in one piece.
  • the wire element 3 consists of a wire strand made of fine steel wires that are intertwined or twisted with one another. In this way, the wire element is given the necessary flexibility with simultaneous rigidity to move the cutting basket.
  • the wire strand 3 is welded to the proximal end of the cutting basket 5.
  • the catheter tube 4 consists of a conventional material and therefore does not require any further explanation.
  • the cutting basket 5 is expediently made of a shape memory material, in particular nitinol, which allows the basket to be given the desired shape so that it can stretch in the catheter tube and take on the impressed expanded shape after it has been extended from the catheter tube.
  • FIG. 2 shows a variant according to the invention of a cutting basket 5 with a distal tip 8 in a planar representation.
  • the basket portion shows three struts 6, each strut 6 carrying a cutting element 7.
  • the cutting edges 7 are designed as hook-shaped cutting noses and are curved in the proximal direction in the direction of the struts 6. They run in the plane of the respective strut.
  • the cutting noses 7 are flanked by recesses in the struts 6. When stripping the venous valves, the venous valves are then held by the recess in front of the cutting edge and cut by pulling back the valvulotome.
  • Proximal to the cutting basket 5 is a pipe segment 9 which is perforated three times and which is used to fix the wire braid 3 by welding and / or gluing.
  • atraumatic tip 8 Distal to the cutting basket 5 is the atraumatic tip 8, which has a spiral incision 10 and one in four
  • the tip 8 is formed from a tube.
  • the spiral circumferential incision 10 gives the tip 8 the property of a helical spring and thus the end arches 11 a certain elasticity.
  • the terminal arches 11 are bent inward, ie deformed in the direction of the tube axis, which prevents the tip 8 from coming into contact with the vessel wall.
  • 3 shows a variant of a cutting basket 5 with 2 cutting noses 7 each. These are located, somewhat offset, on opposite sides of the strut, the cutting edges point in the proximal direction. Two cutting edges per strut in this arrangement increase the "hit rate" when stripping the venous valves.
  • Fig. 4 shows the universal joint-like design of the incision 10 with webs 12 which bridge the incisions. Two webs 12 are expediently provided per turn, the webs 12 being offset from one another by 90 ° in adjacent turns.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Public Health (AREA)
  • Medical Informatics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Pathology (AREA)
  • Surgical Instruments (AREA)

Abstract

The invention relates to a valvulotome with a catheter tube (4) and an expandable basket (5) with cutting elements (7), wherein the catheter tube (4) is suitable for receiving the expandable basket (5) in the non-expanded state, in which the basket (5) is secured to the distal end of a wire element (3) that runs in the catheter tube (4), and the basket (5) distally has an atraumatically designed flexible tip (8).

Description

VALVULOTOM Die Erfindung betrifft einen Valvulotom mit einem Katheterrohr und einem expandierbaren Korb mit Schneidelementen, wobei das Katheterrohr geeignet ist, den expandierbaren Korb in nicht expandiertem Zustand in sich aufzunehmen. VALVULOTOME The invention relates to a valvulotome with a catheter tube and an expandable basket with cutting elements, the catheter tube being suitable for receiving the expandable basket in the non-expanded state.
Bei der Transplantation von körpereigenen Venen in den Herzkranzbereich zur Erstellung von Bypässen ist es erforderlich, die dafür bestimmten Venen zuvor von Venenklappen zu befreien. Venenklappen sind geeignet, den Blutfluss zu behindern, was bei Herzkranzgefäßen, die der Versorgung des Herzmuskels mit arteriellem Blut dienen, unerwünscht ist. Insofern müssen für Bypässe bestimmte körpereigene Venen, die zumeist aus dem Oberschenkelbereich des Patienten entnommen werden, zuvor präpariert werden. Eine solcheWhen transplanting the body's own veins into the coronary area to create bypasses, it is necessary to free the veins from the venous valves beforehand. Venous valves are suitable for obstructing the flow of blood, which is undesirable in the case of coronary vessels that supply the heart muscle with arterial blood. In this respect, certain endogenous veins, which are usually taken from the patient's thigh area, have to be prepared beforehand for bypasses. Such
Präparation findet in der Regel, wenn genügend Zeit bleibt, einige Zeit vor der Bypass-Operation im Körper des Patienten statt, so dass die entsprechenden Gefäße Zeit haben, sich zu erholen und zu verheilen. Dissection usually takes place in the patient's body some time before the bypass operation, if there is enough time, so that the corresponding vessels have time to recover and heal.
Zur Entfernung von Venenklappen im Körper eines Patienten werden sog. Valvulotome eingesetzt, d.h. endovaskuläre Instrumente, die in das entsprechende Gefäß eingeführt werden und mit Hilfe von seitlich angeordneten Schneidmessern die Venenklappen „strippen“. In der Regel erfolgt ein solcher Eingriff mit Hilfe eines Katheters, der am distalen Unterschenkel über die Leiste oder einen anderen Zugangsort in das entsprechende Gefäß des Patienten geführt wird, und durch den anschließend ein an und für sich bekanntes Valvulotom an den Einsatzort transferiert wird. Nach Verlassen des Katheters entfernen die Schneidelemente des Valvulotoms die Venenklappen, die über ein korbähnliches Gebilde in der Nähe der Valvulotomspitze in den Katheter gezogen und mit dem Katheter und dem Valvulotom aus dem Körper des Patienten entfernt werden. To remove venous valves in a patient's body, so-called valvulotomes are used, ie endovascular instruments that are inserted into the corresponding vessel and “strip” the venous valves with the help of laterally arranged cutting blades. Such an intervention is usually carried out with the aid of a catheter, which is guided on the distal lower leg via the groin or another access point into the corresponding vessel of the patient, and through which a known valvulotome is then transferred to the place of use. After exiting the catheter, the cutting elements of the valvulotome remove the venous valves that are over a basket-like structure near the tip of the valvulotome is drawn into the catheter and removed from the patient's body with the catheter and the valvulotome.
Ein derartiges Valvulotom ist beispielsweise aus der WO 96/33662 A1 bekannt, das über einen Kabel geführt wird, über einen Korb als Distanzelement verfügt sowie über Schneidwerkzeuge, die sich in einem Schneidkopf vor dem Korb befinden. Distal befindet sich eine atraumatische Spitze. Such a valvulotome is known, for example, from WO 96/33662 A1, which is guided over a cable, has a basket as a spacer element, and cutting tools that are located in a cutting head in front of the basket. An atraumatic tip is located distally.
Dieses Valvulotom wird durch einen Katheter an den Einsatzort geführt, ist aber nicht selbst steuerbar. Insbesondere ist dieses Valvulotom nicht mit einem Führungsdraht, der Steuerungszwecken dient, kombinierbar. This valvulotome is guided to the place of use through a catheter, but cannot be controlled by itself. In particular, this valvulotome cannot be combined with a guide wire that is used for control purposes.
Des Weiteren sind in diesem bekannten Valvulotom Korb- und Schneidelemente voneinander getrennt, müssen aber Zusammenwirken. Die Schneidelemente sind beweglich in einem Schneidkopf angeordnet und werden mit Hilfe des Korbs, der aus Federelementen besteht, gegen die Gefäßwand gepresst. Furthermore, in this known valvulotome, the basket and cutting elements are separated from one another, but must work together. The cutting elements are movably arranged in a cutting head and are pressed against the vessel wall with the aid of the basket, which consists of spring elements.
Aus der WO 2011/107 249 A1 ist ein Valvulotom bekannt, bei dem sich die Schneidklingen an einem expandierbaren Schneidkorb befinden, wobei der Schneidkorb das distale Ende eines in einem Katheter geführten Rohres darstellt. Der Schneidkorb kann in nicht expandiertem Zustand in den Katheter aufgenommen werden. Das Valvulotom verfügt über einen inneren Führungsdraht zur Steuerung und Positionierung. Eine Manschette dient als distale Begrenzung des Schneidkorbs und erleichtert die Expansion. From WO 2011/107 249 A1 a valvulotome is known in which the cutting blades are located on an expandable cutting basket, the cutting basket representing the distal end of a tube guided in a catheter. The cutting basket can be received in the catheter in the non-expanded state. The valvulotome has an inner guide wire for control and positioning. A cuff serves as a distal limitation of the cutting basket and facilitates expansion.
Nachteilig an dieser Ausführungsform ist der Platzbedarf des zweiten Rohrs und des Führungsdrahts, wobei letzterer die Aufnahmekapazität des Schneidkorbs für Gewebe begrenzt, da er durch den Schneidkopf hindurch geführt ist. Dies begrenzt das Aufnahmevermögen des Schneidkorbs und kann dazu führen, dass dieser wegen anhängender Gewebereste nicht in den Katheter zurückgezogen werden kann. Des Weiteren sind Valvulotome bekannt, die im Wesentlichen aus einem Federkorb bestehen, der Schneidelemente aufweist. Ein solches in die Praxis eingeführtes Valvulotome der Firma LeMaitre ist ebenfalls kathetergeführt und weist einen Korb aus mehreren Streben mit in die Streben integrierten Schneidelementen auf. Auch diese Valvulotome sind nicht selbstständig führbar. The disadvantage of this embodiment is the space required by the second tube and the guide wire, the latter limiting the capacity of the cutting basket for tissue, since it is guided through the cutting head. This limits the capacity of the cutting basket and can mean that it cannot be withdrawn into the catheter because of adhering tissue residues. Furthermore, valvulotomes are known which essentially consist of a spring cage which has cutting elements. Such a valvulotome from LeMaitre, which has been introduced into practice, is also catheter-guided and has a basket made of several struts with cutting elements integrated into the struts. These valvulotomes cannot be guided independently either.
Demgegenüber besteht die Aufgabe der Erfindung darin, ein Valvulotom zu schaffen, das selbstständig an den Einsatzort führbar ist. Des Weiteren soll das Valvulotom soweit steuerbar sein, dass der stripping-Vorgang vom behandelnden Arzt gesteuert und individuell an den Durchmesser und Zustand der Vene des Patienten angepasst werden kann. Insbesondere soll der Korb des Valvulotoms frei von inneren Elementen bleiben, um ein großes Aufnahmevolumen für Gewebereste zu schaffen. In contrast, the object of the invention is to create a valvulotome that can be guided independently to the place of use. Furthermore, the valvulotome should be controllable to such an extent that the stripping process can be controlled by the attending physician and individually adapted to the diameter and condition of the patient's vein. In particular, the basket of the valvulotome should remain free of internal elements in order to create a large volume for tissue remnants.
Diese Aufgabe wird mit einem Valvulotom der eingangs genannten Art gelöst, bei dem der Korb am distalen Ende eines Drahtelements festgelegt ist, dass in dem Katheterrohr verläuft und bei dem der Korb distal eine atraumatisch ausgestaltete und nachgiebige Spitze aufweist. This object is achieved with a valvulotome of the type mentioned at the outset, in which the basket is fixed at the distal end of a wire element that runs in the catheter tube and in which the basket has an atraumatic and flexible tip distally.
Insbesondere sind Schneidkorb und die atraumatische Spitze aus einem Rohr durch Laserschneiden gefertigt. Die Spitze ist damit wie der Schneidkorb hohl. Das erfindungsgemäße Valvulotom ist in einem herkömmlichen Katheter geführt, mit dem es auch zusammen wirkt. Der Katheter wird auf übliche Art und Weise in das Gefäß eines Patienten eingeführt und vom behandelnden Arzt auf übliche Art und Weise über das Drahtelement gesteuert. Bei dem Drahtelement handelt es sich aber nicht um einen herkömmlichen Führungsdraht zur Platzierung des Valvulotoms, da er distal mit dem Schneidkorb des Valvulotoms endet, also nicht in den Schneidkorb hinein und durch ihn hindurch geführt ist. Er dient ausschließlich zur Bewegung des Schneidkorbs. In particular, the cutting basket and the atraumatic tip are made from a tube by laser cutting. Like the cutting basket, the tip is hollow. The valvulotome according to the invention is guided in a conventional catheter with which it also works together. The catheter is introduced into the vessel of a patient in the usual way and is controlled by the attending physician in the usual way via the wire element. The wire element, however, is not a conventional guide wire for placing the valvulotome, since it ends distally with the cutting basket of the valvulotome, that is, it is not guided into and through the cutting basket. It is only used to move the cutting basket.
Der Schneidkorb ist expandierbar, d. h. er kann in nicht expandierter Form im Katheter geführt werden und weitet sich außerhalb des Katheters in seine expandierte Form auf. Aus diesem Grunde besteht er aus einem Federmaterial, insbesondere aus einem Formgedächtnismaterial, beispielsweise Nitinol, das es erlaubt, das Ausmaß der Expansion vorzugeben. Für den Einsatz wird der Schneidkorb mit dem Drahtelement aus dem Katheter hinausgeschoben. The cutting basket is expandable, ie it can be guided in the catheter in its non-expanded form and expands into its expanded form outside of the catheter. For this reason it consists of a spring material, in particular made of a shape memory material, for example nitinol, which allows the extent of the expansion to be specified. For use, the cutting basket with the wire element is pushed out of the catheter.
Das Drahtelement muss aus diesem Grund sowohl eine gewisse Flexibilität als auch Steifigkeit besitzen. Bevorzugt handelt es sich deshalb um eine geflochtene Drahtlitze aus feinen Stahldrähten, die hinreichend Steifigkeit besitzt, um den Schneidkorb aus dem Katheter hinauszuschieben und nach dem Stripping der Venenklappen wieder in den Katheter zurückzuziehen. Dadurch, dass das Drahtelement nicht in den Korb hineinreicht, bleibt dort genügend Platz, um die abgeschnittenen Venenklappen aufzunehmen und mit dem Korb in den Katheter hinein zurückzuziehen. Dies hat sich bei Valvulotomen, bei denen ein Führungsdraht durch den Schneidkopf geführt ist, als problematisch erwiesen. For this reason, the wire element must have both a certain flexibility and rigidity. It is therefore preferably a braided wire strand made of fine steel wires, which has sufficient rigidity to push the cutting basket out of the catheter and to pull it back into the catheter after the venous valves have been stripped. Because the wire element does not extend into the basket, there is enough space to accommodate the cut-off venous valves and to pull them back into the catheter with the basket. This has proven to be problematic in valvulotomes in which a guide wire is passed through the cutting head.
Erfindungsgemäß ist das distale Ende des Schneidkorbs mit einer atraumatischen Spitze versehen, die weich ausgebildet ist, um Schäden an der Gefäßwand zu vermeiden. Dabei hat sich eine Spiralform als sehr vorteilhaft erwiesen, d. h. die atraumatische Spitze hat zumindest partiell die Form einer Schraubenfeder. Die Spiralen einer solchen Schraubenform können dabei durch Streben nach Art eines Kreuzgelenks verbunden sein. Bei Fertigung des Korbs mit Spitze aus einem Rohr durch Laserschneiden ist eine solche Gestaltung ohne weiteres möglich. Vorzugsweise sind Schneidkorb und Spitze einstückig gefertigt, insbesondere aus einem geeigneten Rohr aus einem Formgedächtnismaterial durch Laserschneiden. According to the invention, the distal end of the cutting basket is provided with an atraumatic tip which is designed to be soft in order to avoid damage to the vessel wall. A spiral shape has proven to be very advantageous, i. H. the atraumatic tip is at least partially in the form of a helical spring. The spirals of such a helical shape can be connected by struts in the manner of a universal joint. Such a design is readily possible when the basket with the tip is manufactured from a tube by laser cutting. The cutting basket and tip are preferably made in one piece, in particular from a suitable tube made of a shape memory material by laser cutting.
Die atraumatische Spitze kann zusätzlich zu einer partiellen Spiralform distal mehrere Bögen aufweisen, die zur weichen Ausbildung der Spitze und ihrem atraumatischen Charakter beitragen. Bevorzugt sind drei oder vier Bögen, die in Richtung auf die Längsachse der Spitze einwärts gebogen sind. Dies dient der Steuerung des Valvulotoms bei der Einführung in ein Gefäß und erleichtert die Positionierung. Im Transportzustand befindet sich das erfindungsgemäße Valvulotom mit seinem Korb im Katheter, d. h. der Korb nimmt im Katheter eine gestreckte Form an. Nach Freisetzung aus dem Katheter spannt sich der Korb auf. Die atraumatische Spitze des Schneidkorbs ragt aus dem Katheter hinaus; dies erleichtert die Steuerung des Valvulotoms im Gefäß. Die Steuerung erfolgt also nicht über einen Führungsdraht. Der Korb weist mehrere Streben auf, die die Schneidelemente tragen. Vorzugsweise hat der Korb drei Streben mit jeweils einem oder zwei Schneidelementen. Die Ausführung mit drei Streben hat den Vorteil, dass sich der Korb im Gefäß selbst zentriert. Bei zwei Schneidelementen pro Strebe liegen die Schneidelemente auf gegenüberliegenden Seiten der Strebe, weisen dabei aber mit ihren Schneiden in die gleiche Richtung. In addition to a partial spiral shape, the atraumatic tip can have several arcs distally, which contribute to the soft formation of the tip and its atraumatic character. Preferred are three or four arcs which are bent inwardly towards the longitudinal axis of the tip. This is used to control the valvulotome when it is introduced into a vessel and to facilitate positioning. In the transport state, the valvulotome according to the invention is with its basket in the catheter, ie the basket takes a stretched one in the catheter Shape. Once released from the catheter, the basket will expand. The atraumatic tip of the cutting basket protrudes from the catheter; this makes it easier to control the valvulotome in the vessel. Control is therefore not carried out via a guide wire. The basket has several struts that support the cutting elements. The basket preferably has three struts, each with one or two cutting elements. The design with three struts has the advantage that the basket centers itself in the vessel. With two cutting elements per strut, the cutting elements are on opposite sides of the strut, but point with their cutting edges in the same direction.
Die Streben des Korbs sind distal in der atraumatisch ausgebildeten Spitze zusammengeführt. Spitze und Korb können dabei verklebt oder verschweißt sein, vorzugsweise sind sie aber einstückig durch Laserschweißen aus einem Rohr, insbesondere einem Rohr aus einem Formgedächtnismaterial, gefertigt. Die Schneidelemente haben vorzugsweise hakenförmige Schneidnasen, die in der Ebene der Streben verlaufen. Insbesondere sind die Schneidnasen von Rücksprüngen der Streben flankiert, sodass sie mit ihrer Schneidfläche, insbesondere einem Schneidbogen, im Längsverlauf der Streben verbleiben. Beim Strippen der Venenklappen werden die Venenklappen dann in dem von der Schneide liegenden Rücksprung gehalten, durch Zurückziehen des Valvulotoms gekappt und gelangen dann in das Korbinnere und werden mit dem Korb in den Katheter gezogen. Zwei Schneidelemente pro Strebe vereinfachen das Strippen. The struts of the basket are brought together distally in the atraumatic tip. The tip and basket can be glued or welded, but they are preferably made in one piece by laser welding from a tube, in particular a tube made of a shape memory material. The cutting elements preferably have hook-shaped cutting noses which run in the plane of the struts. In particular, the cutting noses are flanked by recesses in the struts, so that their cutting surface, in particular a cutting arc, remains in the longitudinal course of the struts. When stripping the venous valves, the venous valves are then held in the recess from the cutting edge, cut by pulling back the valvulotome and then get into the inside of the basket and are pulled into the catheter with the basket. Two cutting elements per strut simplify stripping.
Das Drahtelement ist im Katheter beweglich angeordnet, sodass der Korb vorgeschoben, gedreht und zurückgezogen werden kann, dies auch mehrfach, um den ausgewählten Venenabschnitt von den Venenklappen zu befreien. The wire element is movably arranged in the catheter so that the basket can be advanced, rotated and withdrawn, also several times, in order to free the selected vein section from the venous valves.
Das erfindungsgemäße Valvulotom kann übliche röntgendichte Markerelemente aufweisen, die insbesondere im Bereich des distalen Endes des Katheterrohrs angeordnet sein können. Es versteht sich, dass das erfindungsgemäße Valvulotom in verschiedenen Größen vorliegen kann, beispielsweise mit einem 5F-Katheter und einem Schneidkorb, der aus einem 4F-Nitinolrohr geschnitten ist. Das Drahtelement ist beispielsweise eine Stahldrahtlitze mit einer Stärke von 0,85 mm. Es versteht sich, dass der hier verwandte Begriff „distal“ das vom behandelnden Arzt abgewandte Ende des Valvulotoms, Katheters oder Drahtelements bezeichnet, der Begriff „proximal“ das dem behandelnden Arzt zugewandte Ende. The valvulotome according to the invention can have conventional radiopaque marker elements, which can be arranged in particular in the region of the distal end of the catheter tube. It goes without saying that the valvulotome according to the invention can be present in different sizes, for example with a 5F catheter and a cutting basket cut from a 4F nitinol tube. The wire element is, for example, a steel wire strand with a thickness of 0.85 mm. It goes without saying that the term “distal” used here denotes the end of the valvulotome, catheter or wire element facing away from the attending physician, the term “proximal” the end facing the attending physician.
Die Erfindung wird durch die beiliegenden Abbildungen näher erläutert. Es zeigen The invention is explained in more detail by the accompanying figures. Show it
Fig. 1: ein erfindungsgemäßes Valvulotom mit expandiertem Korb, 1: a valvulotome according to the invention with an expanded basket,
Fig. 2: eine flächige Darstellung des Korbs mit 3 Schneidelementen und Spitze, Fig. 3: eine flächige Darstellung des Korbs mit 6 Schneidelementen und Spitze, und FIG. 2: a planar representation of the basket with 3 cutting elements and a point, FIG. 3: a planar representation of the basket with 6 cutting elements and a point, and
Fig. 4: eine kreuzgelenkmäßige Gestaltung der Spitze. Fig. 4: a universal joint-like design of the tip.
Figur 1 zeigt ein erfindungsgemäßes Valvulotom zusammen mit der Einführschleuse 1, dem Griff 2 für die Bewegung des Drahtelements 3. Das Valvulotom besteht in erster Linie aus dem Katheterrohr 4, dem Drahtelement 3, dem Schneidkorb 5 und der atraumatisch ausgebildeten, weichen Spitze 8. Der Schneidkorb 5 ist in der Darstellung aus dem Katheterrohr 4 ausgefahren, expandiert und zum Einsatz in einer Vene zum Strippen der Venenklappen bereit. Er weist drei Streben 6 auf, jede mit einem Schneidelement 7 versehen. Der Schneidkorb 5 selbst ist proximal mit einer atraumatischen und weichen Spitze 8 versehen. Schneidkorb 5 und Spitze 8 bestehen aus dem gleichen Material und sind einstückig gefertigt. Das Drahtelement 3 besteht aus einer Drahtlitze aus feinen Stahldrähten, die miteinander verflochten oder verdrillt sind. Auf diese Art und Weise erhält das Drahtelement die nötige Flexibilität bei gleichzeitiger Steifigkeit, um den Schneidkorb zu bewegen. Die Drahtlitze 3 ist mit dem proximalen Ende des Schneidkorbs 5 verschweißt. Figure 1 shows an inventive valvulotome together with the introducer 1, the handle 2 for moving the wire element 3. The valvulotome consists primarily of the catheter tube 4, the wire element 3, the cutting basket 5 and the atraumatic, soft tip 8. The In the illustration, the cutting basket 5 is extended from the catheter tube 4, expanded and ready for use in a vein for stripping the venous valves. It has three struts 6, each provided with a cutting element 7. The cutting basket 5 itself is provided with an atraumatic and soft tip 8 proximally. Cutting basket 5 and tip 8 are made of the same material and are made in one piece. The wire element 3 consists of a wire strand made of fine steel wires that are intertwined or twisted with one another. In this way, the wire element is given the necessary flexibility with simultaneous rigidity to move the cutting basket. The wire strand 3 is welded to the proximal end of the cutting basket 5.
Das Katheterrohr 4 besteht aus einem herkömmlichen Material und bedarf daher keiner näheren Erläuterung. Der Schneidkorb 5 besteht zweckmäßigerweise aus einem Formgedächtnismaterial, insbesondere Nitinol, das es erlaubt, dem Korb die gewünschte Form aufzuprägen, sodass er sich im Katheterrohr strecken kann und nach dem Ausfahren aus dem Katheterrohr die aufgeprägte expandierte Form annehmen kann. The catheter tube 4 consists of a conventional material and therefore does not require any further explanation. The cutting basket 5 is expediently made of a shape memory material, in particular nitinol, which allows the basket to be given the desired shape so that it can stretch in the catheter tube and take on the impressed expanded shape after it has been extended from the catheter tube.
Fig. 2 zeigt eine erfindungsgemäße Variante eines Schneidkorbs 5 mit distaler Spitze 8 in flächiger Darstellung. Der Korbanteil zeigt drei Streben 6, wobei jede Strebe 6 ein Schneidelement 7 trägt. Die Schneiden 7 sind als hakenförmige Schneidnasen ausgebildet und in Richtung auf die Streben 6 nach proximal gekrümmt. Sie verlaufen in der Ebene der jeweiligen Strebe. Die Schneidnasen 7 sind von Rücksprüngen der Streben 6 flankiert. Beim Strippen der Venenklappen werden die Venenklappen dann von dem vor der Schneide liegenden Rücksprung gehalten und durch Zurückziehen des Valvulotoms gekappt. 2 shows a variant according to the invention of a cutting basket 5 with a distal tip 8 in a planar representation. The basket portion shows three struts 6, each strut 6 carrying a cutting element 7. The cutting edges 7 are designed as hook-shaped cutting noses and are curved in the proximal direction in the direction of the struts 6. They run in the plane of the respective strut. The cutting noses 7 are flanked by recesses in the struts 6. When stripping the venous valves, the venous valves are then held by the recess in front of the cutting edge and cut by pulling back the valvulotome.
Proximal zum Schneidkorb 5 befindet sich ein Rohrsegment 9, das dreifach durchbrochen ist und der Festlegung der Drahtlitze 3 durch Verschweißen und/oder Verkleben dient. Proximal to the cutting basket 5 is a pipe segment 9 which is perforated three times and which is used to fix the wire braid 3 by welding and / or gluing.
Distal zum Schneidkorbs 5 befindet sich die atraumatisch ausgebildete Spitze 8, die über einen spiralig umlaufenden Einschnitt 10 verfügt sowie ein in vierDistal to the cutting basket 5 is the atraumatic tip 8, which has a spiral incision 10 and one in four
Bögen 11 auslaufendes distales Ende. Die Spitze 8 ist, wie vorstehend ausgeführt, aus einem Rohr geformt. Der spiralig umlaufende Einschnitt 10 verleiht der Spitze 8 die Eigenschaft einer Schraubenfeder und damit den endständigen Bögen 11 eine gewisse Elastizität. Die endständigen Bögen 11 sind nach innen gebogen, d. h. in Richtung auf die Rohrachse umgeformt, was verhindert, dass die Spitze 8 mit der Gefäßwand in Kontakt kommt. Fig. 3 zeigt eine Variante eines Schneidkorbs 5 mit jeweils 2 Schneidnasen 7. Diese befinden sich, etwas versetzt, auf gegenüberliegenden Seiten der Strebe, die Schneiden weisen nach proximal. Zwei Schneiden pro Strebe in dieser Anordnung erhöhen die „Trefferquote“ beim Strippen der Venenklappen. Fig. 4 zeigt die kreuzgelenkartige Ausbildung des Einschnitts 10 mit Stegen 12, die die Einschnitte überbrücken. Zweckmäßig sind zwei Stege 12 pro Windung vorgesehen, wobei die Stege 12 in benachbarten Windungen um 90° gegeneinander versetzt sind. Arches 11 terminating distal end. As stated above, the tip 8 is formed from a tube. The spiral circumferential incision 10 gives the tip 8 the property of a helical spring and thus the end arches 11 a certain elasticity. The terminal arches 11 are bent inward, ie deformed in the direction of the tube axis, which prevents the tip 8 from coming into contact with the vessel wall. 3 shows a variant of a cutting basket 5 with 2 cutting noses 7 each. These are located, somewhat offset, on opposite sides of the strut, the cutting edges point in the proximal direction. Two cutting edges per strut in this arrangement increase the "hit rate" when stripping the venous valves. Fig. 4 shows the universal joint-like design of the incision 10 with webs 12 which bridge the incisions. Two webs 12 are expediently provided per turn, the webs 12 being offset from one another by 90 ° in adjacent turns.
- Patentansprüche - - patent claims -

Claims

Patentansprüche Claims
1. Valvulotom mit einem Katheterrohr (4) und einem expandierbaren Korb (5) mit Schneidelementen (7), wobei das Katheterrohr (4) geeignet ist, den expandierbaren Korb (5) in nicht expandiertem Zustand in sich aufzunehmen, dadurch gekennzeichnet, dass der Korb (5) am distalen Ende eines Drahtelements (3) festgelegt ist, das in dem Katheterrohr (4) verläuft und dass der Korb (5) distal eine atraumatisch ausgestaltete nachgiebige Spitze (8) aufweist. 1. Valvulotome with a catheter tube (4) and an expandable basket (5) with cutting elements (7), wherein the catheter tube (4) is suitable to receive the expandable basket (5) in the non-expanded state, characterized in that the Basket (5) is fixed at the distal end of a wire element (3) which runs in the catheter tube (4) and that the basket (5) distally has an atraumatic flexible tip (8).
2. Valvulotom nach Anspruch 1, dadurch gekennzeichnet, dass das Drahtelement (3) eine geflochtene Stahldrahtlitze ist. 2. Valvulotome according to claim 1, characterized in that the wire element (3) is a braided steel wire strand.
3. Valvulotom nach Anspruch 1 oder 2, dadurch gekennzeichnet, dass das Drahtelement (3) mit dem proximalen Ende des expandierbaren Korbs (5) verklebt und/oder verschweißt ist. 3. Valvulotome according to claim 1 or 2, characterized in that the wire element (3) is glued and / or welded to the proximal end of the expandable basket (5).
4. Valvulotom nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass die atraumatisch ausgebildete Spitze (8) und der expandierbare Korb (5) einstückig ausgebildet sind. 4. Valvulotome according to one of the preceding claims, characterized in that the atraumatic tip (8) and the expandable basket (5) are integrally formed.
5. Valvulotom nach Anspruch 4, dadurch gekennzeichnet, dass die atraumatisch ausgebildete Spitze (8) und der expandierbare Korb (5) aus einem Formgedächtnismaterial, vorzugsweise Nitinol bestehen. 5. Valvulotome according to claim 4, characterized in that the atraumatic tip (8) and the expandable basket (5) consist of a shape memory material, preferably nitinol.
6. Valvulotom nach Anspruch 5, dadurch gekennzeichnet, dass die atraumatisch ausgebildete Spitze (8) und der expandierbare Korb (5) aus einem Rohr geschnitten sind. 6. valvulotome according to claim 5, characterized in that the atraumatic tip (8) and the expandable basket (5) are cut from a tube.
7. Valvulotom nach Anspruch 6, dadurch gekennzeichnet, dass die atraumatisch ausgebildete Spitze (8) einen spiralförmig umlaufenden Einschnitt (10) aufweist. 7. valvulotome according to claim 6, characterized in that the atraumatic tip (8) has a spiral-shaped circumferential incision (10).
8. Valvulotom nach Anspruch 7, dadurch gekennzeichnet, dass Einschnitt (10) nach Art eines Kreuzgelenks mit Stegen (12) versehen ist. 8. Valvulotome according to claim 7, characterized in that the incision (10) is provided with webs (12) in the manner of a universal joint.
9. Valvulotom nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass der Korb (5) drei Streben (6) mit jeweils ein oder zwei Schneidelementen (7) aufweist. 9. Valvulotome according to one of the preceding claims, characterized in that the basket (5) has three struts (6) each with one or two cutting elements (7).
10. Valvulotom nach Anspruch 9, dadurch gekennzeichnet, dass die Streben (6) distal in der atraumatisch ausgebildeten Spitze (8) zusammengeführt sind. 10. valvulotome according to claim 9, characterized in that the struts (6) are brought together distally in the atraumatic tip (8).
11. Valvulotom nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass die Schneidelemente (7) hakenförmige Schneidnasen aufweisen, die in der Ebene der Streben (6) verlaufen, wobei die Schneidnasen von Rücksprüngen der Streben (12) flankiert sind. 11. Valvulotome according to one of the preceding claims, characterized in that the cutting elements (7) have hook-shaped cutting noses which run in the plane of the struts (6), the cutting noses being flanked by recesses of the struts (12).
12. Valvulotom nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass das Drahtelement (3) in dem Katheterrohr (4) beweglich geführt ist. 12. Valvulotome according to one of the preceding claims, characterized in that the wire element (3) is movably guided in the catheter tube (4).
13. Valvulotom nach einem der vorstehenden Ansprüche, dadurch gekennzeichnet, dass es ein röntgendichtes Markerelement im Bereich des distalen Endes des Katheterrohrs (4) aufweist. 13. Valvulotome according to one of the preceding claims, characterized in that it has a radiopaque marker element in the region of the distal end of the catheter tube (4).
- Zusammenfassung - - Summary -
EP21705106.9A 2020-01-22 2021-01-21 Valvulotome Pending EP4093303A1 (en)

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DE102020101456.2A DE102020101456A1 (en) 2020-01-22 2020-01-22 Valvulotome
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US5158564A (en) * 1990-02-14 1992-10-27 Angiomed Ag Atherectomy apparatus
US5658301A (en) 1995-04-26 1997-08-19 Vascutech, Inc. Self-centering valvulotome
DE102010009723A1 (en) * 2010-03-01 2011-09-01 Andramed Gmbh Guidewire / catheter guided valvulotome
US10039900B2 (en) * 2010-09-07 2018-08-07 Angiodynamics, Inc. Fluid delivery and treatment device and method of use
DE102013019890A1 (en) * 2013-11-28 2015-05-28 Bentley Innomed Gmbh Medical implant
CA3046543A1 (en) * 2016-03-14 2017-09-21 Universite Catholique De Louvain Device for clean excision of a heart valve
WO2018189593A2 (en) * 2017-04-10 2018-10-18 Limflow Gmbh Devices and methods for treating lower extremity vasculature

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