EP4093303A1 - Valvulotome - Google Patents
ValvulotomeInfo
- 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
Links
- 238000005520 cutting process Methods 0.000 claims abstract description 71
- 210000001331 nose Anatomy 0.000 claims description 7
- 239000012781 shape memory material Substances 0.000 claims description 5
- 229910000831 Steel Inorganic materials 0.000 claims description 4
- HLXZNVUGXRDIFK-UHFFFAOYSA-N nickel titanium Chemical compound [Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ti].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni].[Ni] HLXZNVUGXRDIFK-UHFFFAOYSA-N 0.000 claims description 4
- 229910001000 nickel titanium Inorganic materials 0.000 claims description 4
- 239000010959 steel Substances 0.000 claims description 4
- 239000003550 marker Substances 0.000 claims description 2
- 210000002073 venous valve Anatomy 0.000 description 14
- 210000003462 vein Anatomy 0.000 description 6
- 238000003698 laser cutting Methods 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 210000001519 tissue Anatomy 0.000 description 2
- 238000003466 welding Methods 0.000 description 2
- 238000004026 adhesive bonding Methods 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 210000004013 groin Anatomy 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 210000004165 myocardium Anatomy 0.000 description 1
- 125000006850 spacer group Chemical group 0.000 description 1
- 231100000732 tissue residue Toxicity 0.000 description 1
- 210000000689 upper leg Anatomy 0.000 description 1
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.
Landscapes
- 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
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
DE102020101456.2A DE102020101456A1 (en) | 2020-01-22 | 2020-01-22 | Valvulotome |
PCT/EP2021/051240 WO2021148490A1 (en) | 2020-01-22 | 2021-01-21 | Valvulotome |
Publications (1)
Publication Number | Publication Date |
---|---|
EP4093303A1 true EP4093303A1 (en) | 2022-11-30 |
Family
ID=74595253
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP21705106.9A Pending EP4093303A1 (en) | 2020-01-22 | 2021-01-21 | Valvulotome |
Country Status (4)
Country | Link |
---|---|
US (1) | US20230052106A1 (en) |
EP (1) | EP4093303A1 (en) |
DE (1) | DE102020101456A1 (en) |
WO (1) | WO2021148490A1 (en) |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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 |
-
2020
- 2020-01-22 DE DE102020101456.2A patent/DE102020101456A1/en active Pending
-
2021
- 2021-01-21 EP EP21705106.9A patent/EP4093303A1/en active Pending
- 2021-01-21 US US17/794,397 patent/US20230052106A1/en active Pending
- 2021-01-21 WO PCT/EP2021/051240 patent/WO2021148490A1/en unknown
Also Published As
Publication number | Publication date |
---|---|
DE102020101456A1 (en) | 2021-07-22 |
WO2021148490A1 (en) | 2021-07-29 |
US20230052106A1 (en) | 2023-02-16 |
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Legal Events
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Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE |
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PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
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Effective date: 20220822 |
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AK | Designated contracting states |
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DAX | Request for extension of the european patent (deleted) | ||
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17Q | First examination report despatched |
Effective date: 20240403 |