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WO2025078016A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

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Publication number
WO2025078016A1
WO2025078016A1 PCT/EP2023/078357 EP2023078357W WO2025078016A1 WO 2025078016 A1 WO2025078016 A1 WO 2025078016A1 EP 2023078357 W EP2023078357 W EP 2023078357W WO 2025078016 A1 WO2025078016 A1 WO 2025078016A1
Authority
WO
WIPO (PCT)
Prior art keywords
curved cutting
cutting members
versions
curved
members
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
PCT/EP2023/078357
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English (en)
Inventor
Falah Redha
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.)
Individual
Original Assignee
Individual
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Filing date
Publication date
Application filed by Individual filed Critical Individual
Priority to PCT/EP2023/078357 priority Critical patent/WO2025078016A1/fr
Publication of WO2025078016A1 publication Critical patent/WO2025078016A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • 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
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00862—Material properties elastic or resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22079—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with suction of debris
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/221—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions
    • A61B2017/2215—Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions having an open distal end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • the technology relates to a medical device for removing material from a hollow anatomic structure and methods of removing material from a hollow anatomic structure.
  • Thrombolysis is the breakdown of blood clots using fibrolytics which targets fibrin; one of the main constituent of blood clots.
  • this treatment does not always provide effective and complete thrombus removal in a very short time, and may require additional therapeutic adjuncts. Moreover, this can lead to small pieces of the blood clot attached to the vessel walls remaining in the vessel after treatment.
  • the later stages of thrombus are more cellular and contain leukocytes, which develops a fibrotic collagenous framework that is more resistant to thrombolysis and therefore requires removal with a thrombectomy device instead.
  • Thrombectomy is a surgical procedure to remove a blood clot from blood vessels. The clot is removed and the blood vessel is repaired to restore the blood flow.
  • Thrombectomy devices typically include introducers, guide wires and a guiding catheter to navigate to the thrombus with the help of contrast media to reach the target vessels. Depending on the site, the size and the age of the thrombus, different methods and thrombectomy devices are available. These devices typically use aspiration or water jets to remove the thrombus from the vessels. Another approach to remove the thrombus is by capturing the thrombus through self-expanded stents, nets or spirals. However, these devices allow thrombus fragments (emboli) to travel downstream which can lead to blockage of other vessels.
  • Another approach to remove the thrombus from the blood vessel is a self-expandable cutting elements, such as those disclosed in US5725543, US5152773, US5282813, US5902313, US7645290 and US8795304.
  • the cutting elements contain finger like elements, which allow thrombus fragments (emboli) to travel downstream through the gaps in the finger like elements which can lead to blockage of other vessels.
  • Previous attempts to prevent downstream movement of thrombus fragments include a thrombectomy device with an expandable funnel, as disclosed in US2017303949 and US8506512, which expand to the blood vessel diameter to stop the blood flow and have the ability to capture the entire thrombus inside it without fragmentation.
  • thrombectomy devices with an expandable funnel, as disclosed in US2017303949 and US8506512, which expand to the blood vessel diameter to stop the blood flow and have the ability to capture the entire thrombus inside it without fragmentation.
  • these devices remove the clot wholly or entirely and do not fragment the thrombus, these devices are limited to a smaller size of thrombus that they can remove.
  • Devices for removing thrombi and/or emboli from vasculature can also be used to remove other foreign materials from a hollow anatomic structure, such as a cancerous tumour, to improve the patient’s health.
  • a medical device (1) for removing material (2) from a hollow anatomic structure (3) including: a first body (11) with a lumen; and a second body (12) with a lumen, wherein the second body is elongate, the second body having a collapsed configuration and an expanded configuration, and the second body (12) including curved cutting members (121 , 122), wherein in the collapsed configuration the curved cutting members (121 , 122) are at least partially disposed within the first body (1 1), and wherein in the expanded configuration distal portions (1213, 1223) of the curved cutting members (121 , 122) slide over each other to expand radially outwardly from their position in the collapsed configuration, such that the second body (12) forms a funnel in the expanded configuration and material entering the funnel is directed through at least one of the lumen of the first body (11) and the lumen of the second body (12).
  • the curved cutting members (121 , 122) may be attached at a distal end of another part of the second body (12).
  • the other part of the second body (12) may be a catheter.
  • each curved cutting member (121 , 122) may be attached to the other part of the second body (12) and may be narrower than the distal portion of the curved cutting member (121 , 122).
  • the curved cutting members (121 , 122) may be biased radially outwardly when the second body (12) is in the collapsed configuration.
  • each curved cutting members (121 , 122) may include at least one cutting edge (1211 , 1221).
  • each curved cutting member (121 , 122) may be located at a distal end of the curved cutting member (121 , 122).
  • each curved cutting member (121 , 122) may be angled inwardly towards a central longitudinal axis of the second body (12).
  • the at least one cutting edge may form a triangular- or saw-tooth arrangement.
  • the distal portions (1213, 1223) of the curved cutting members (121 , 122) may have a larger diameter relative to the diameter of the proximal portions (1212, 1222) of the curved cutting members (121 , 122).
  • Each curved cutting member (121 ,122) may be attached to the other part of the second body (12) by one or more extensions of the curved cutting member (121 , 122) which are received by the other part of the second body (12).
  • Each curved cutting member (121 , 122) may include a bridging member (14) which projects from an outer surface of the curved cutting member (121 , 122) and is received by the other part of the second body (12).
  • Each curved cutting member (121 , 122) may include a bridging member (14) which projects from an outer surface or may be attached to an inner surface of the curved cutting member (121 , 122).
  • the device may further include a third body (15) configured to release fluid into the hollow anatomic structure (3) and/or a volume defined by the second body (12)
  • the third body (15) may be configured to extend through the first body (11) and the second body (12).
  • the device may further include a spiral member (16) or self-expandable stent (17) configured to assist with the removal of the material from the hollow anatomic structure (3).
  • the first body (11) may include a catheter.
  • the first body (11) may include a marking ring (1 11) or band configured to show the position of the device (1) within the hollow anatomic structure (3).
  • the marking ring (1 11) may be a metallic ring.
  • the marking ring (111) may be a radiopaque band.
  • the curved cutting members (1212, 1222) may be configured to at least partially overlap each other.
  • Proximal portions (1212, 1222) of the curved cutting members (121 , 122) may be configured to remain within the lumen of the first body (11) with the second body (12) in the expanded configuration.
  • At least one of the curved cutting members (121 , 122) may be a different size and/or shape compared to another of the curved cutting members (121 , 122).
  • the device may further include a membrane member (19) in the form of a collar at least partially surrounding a proximal portion of the curved cutting members (121 , 122), wherein the membrane member (19) may be configured to inhibit the movement of material out of the funnel though gaps between the curved cutting members (19).
  • Each of the curved cutting members (121 , 122) may further define one or more slots (1214, 1224) through at least part of a depth of the curved cutting member (121 , 122).
  • the curved cutting members (121 ,122) may each include a gliding member (14) located on an outer surface of the cutting member (121 , 122) and protruding therefrom, the gliding member (14) may be configured to abut the first body (1 1) and to separate at least one other part of the curved cutting member (121 , 122) from contact with the first body (11).
  • the second body (12) may further include an attachment ring (1217) to which the curved cutting members (121 , 122) are attached.
  • the material (2) may include thrombi, emboli, atherosclerosis, restenosis or tumours, or any combination thereof.
  • Figure 1 shows a partial cutaway view of the device in the collapsed configuration in accordance with some versions of the technology
  • Figure 2 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology
  • Figure 4 shows a partial cutaway view of the device in the collapsed configuration in accordance with some versions of the technology
  • Figure 5 shows a partial cutaway view of the device in the collapsed configuration in accordance with some versions of the technology
  • Figure 6 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology
  • Figures 7-9 shows a transverse cross-sectional view of the device in accordance with some versions of the technology
  • Figure 10 shows a partial cutaway view of the device in the collapsed configuration in accordance with some versions of the technology
  • Figures11-12 shows a transverse cross-sectional view of the device in accordance with some versions of the technology
  • Figure 13 shows a view of the curved cutting member of the device in accordance with some versions of the technology
  • Figures 14A-D shows a curved cutting member of the device in accordance with some versions of the technology
  • Figure 15 shows a schematic representation of the curved cutting members of the device in the expanded configuration in accordance with some versions of the technology
  • Figure 16 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology
  • Figure 17 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology
  • Figure 18 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology
  • Figure 19 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology
  • Figure 20 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology
  • Figure 21 shows a partial cutaway view of the device in the expanded configuration in accordance with some versions of the technology.
  • the technology provides a medical device for removing material from a hollow anatomic structure.
  • the medical device may be introduced to the hollow anatomic structure (e.g. through an incision and through a thin flexible Introducer sheath) and may move along at least part of a length of the hollow anatomic structure to reach the location of the material to be removed.
  • the device may then be used to remove the material (or at least part of the material) and the device may be removed from the hollow anatomic structure either after, or with, removal of the material.
  • the medical device may include a first body with a lumen (i.e. a lumen defined, at least in part, by the first body, which may be referred to therefore as the first body lumen).
  • the first body may be, or may be part of, a catheter, for example (or an object, such as a marking ring attached to a catheter.
  • the material may then travel through the funnel formed by second body (e.g. by the curved cutting members) to be removed, for example, from the hollow anatomic structure via the lumen of the first body and/or the lumen of the second body.
  • second body e.g. by the curved cutting members
  • the curved cutting members of the device may be used to cut a thrombus to dislodge the thrombus (which is an example of the material) from a blood vessel (which is an example of the hollow anatomic structure).
  • the thrombus may travels through the funnel formed by the second body (e.g. by the expanded curved cutting members) to be removed from the blood vessel via the lumen of the first body and/or by the lumen of the second body.
  • the funnel of the device may prevent or substantially inhibit fragments of the thrombus, which may occur as the material is cut by the curved cutting members, from travelling downstream of the device and causing blockages elsewhere in the blood vessel, for example.
  • the device (1) may be configured to remove material (2) from the hollow anatomic structure (3).
  • the device (1) may include the first body (1 1) with the lumen (in other words, the first body (11) may at least partially define the lumen).
  • the first body (11) may surround the lumen but in some versions the first body (11) may only partially surround the lumen (for example, the first body (11) may be an open sided structure).
  • the first body may be a catheter, for example, a guiding catheter.
  • the first body may be a distal portion of the catheter (e.g. guiding catheter) and, in some versions, the first body may be an attachment located at the distal portion of the catheter (e.g. guiding catheter).
  • the first body (11) may include a marking ring (1 11) or band.
  • the marking ring (11) or band may be a marker to show the position of the device within the hollow anatomic structure (3).
  • the marking ring (11) may also or alternatively assist in facilitating the movement of the first body (11) through the hollow anatomic structure (3) - e.g. by providing a portion of the first body (11) with increased rigidity and/or by providing a rounded end portion for the first body (11).
  • the marking ring (11) may assist in facilitating movement of the second body (12) and curved cutting members (121 , 122) through the first body (1 1) (e.g. by reducing friction between the first body (11) and the second body (12)).
  • the marking ring (1 11) may be a metallic ring.
  • the marking ring (1 11) may be a radiopaque ring.
  • the marking ring (11) may be considered in some versions to be a part of the first body (1 1) of the device (1) or may be considered to be secured to the first body (11).
  • the marking ring (1 1) is secured to the first body (1 1) by embedding of the marking ring (1 11) in the first body (11) (e.g. by over moulding of first body (1 1) around the marking ring (11 1)).
  • the marking ring (11) is secured to the first body (11) by use of an adhesive or by welding.
  • the marking ring (111) may receive at least part of an end of the first body (11) and may be pinched to trap that part within the marking ring (11) to secure the marking ring (111) and the first body (11) together. Other methods of providing the marking ring (111) as part of or secured to the first body (11) are envisaged.
  • Figure 2 shows an example of the device (1) with the second body (12) in its expanded configuration.
  • this movement may be the result of the curved cutting members (121 , 122) being biased outwardly and, with the second body (12) in the collapsed configuration, outward movement of the curved cutting members (121 , 122) may be restrained (e.g. prevented or substantially inhibited) by the first body (11).
  • the curved cutting members (121 , 122) may abut the first body (11) (or the marking ring (1 11) in some versions) to restrain their movement outwardly under the outward bias (i.e. the biasing force).
  • the restraint provided thereby may be reduced or removed to allow for the outward movement of the curved cutting members (121 , 122).
  • This outward movement may be radial outward movement from the position of the curved cutting members (121 , 122) with the second body (12) in its collapsed configuration (and references to outward movement herein should be construed accordingly).
  • the distal portions (1213, 1223) of the curved cutting members (121 , 122) may move outwardly from their initial position (the initial position being their position when the second body (12) is in its collapsed configuration). (I don’t see or read that the curved cutting members (121 , 122) are elastic and or self-expandable)
  • the second body (12) forming the funnel and, in particular, the curved cutting members (121 , 122) forming the funnel.
  • the distal portions (1213, 1223) of the curved cutting members (121 , 122) by define an opening with a first diameter and the proximal portions of the curved cutting members (121 , 122) by define an opening with a second diameter.
  • the first diameter may be larger than the second diameter such that the curved cutting members (121 , 122) form the funnel.
  • the cutting edges (1211 , 1221) may be configured to cut or abrade (or otherwise sever) the material (2).
  • each curved cutting member (121 , 122) could take a number of different forms.
  • each curved cutting member (121 , 122) is curved across its width and a curve may be present throughout substantially an entire length of each curved cutting member (121 , 122).
  • the length of each curved cutting member (121 , 122) may be defined between its respective distal and proximal ends and the cutting edge (1211 , 1221) may be provided at the distal end thereof.
  • each curved cutting member (121 , 122) may be curved.
  • the provision of a narrower proximal portion (1212, 1222) compared to the distal portion (1213, 1223) may aid in the movement of the curved cutting members (121 , 122) radially outwardly - as described herein.
  • curved cutting members (121 , 122) which are narrower (i.e. which have a smaller width) at their proximal portions (1212, 1222) than at their distal portions (1213, 1223) may mean that it is the narrower proximal portions (1212, 1222) which are attached to another part of the second body (12) such as the catheter of the second body (12).
  • the proximal portions (1212, 1222) of the curved cutting members (121 , 122) may be attached to a distal portion of the catheter of the second body (12).
  • the curved cutting members (121 , 122) may be attached to a distal end of the catheter of the second body (12).
  • the proximal ends of the curved cutting members (121 , 122) may be attached to the distal end of the catheter of the second body (12).
  • the outward expansion of the distal portions (1213, 1223) may be restricted - as described herein - by the first body (11).
  • axial movement of the second body (12) to extend out of the first body (11) removes this restriction and permits the outward movement (or expansion) of the distal portions (1212, 1223) of the curved cutting members (121 , 122) - e.g. towards the expanded configuration.
  • the first body (1 1) may act on an outer surface of the curved cutting members (121 , 122) forcing them against the outward bias back to the collapsed configuration of the second body (12).
  • the outer surface of the curved cutting members (121 , 122) may slide past the distal portion of the first body (11) (or marking ring (111)) and may be in engagement therewith.
  • curved cutting members (121 , 122) may be used such that more outward biasing force may be provided by one curved cutting member (121 , 122) than by another.
  • one curved cutting member (121 , 122) may act on another to force that curved cutting member (121 , 122) outwardly.
  • the curved cutting members (121 , 122) may be attached for axial movement with another part of the second body (12), such as the catheter. This can allow the curved cutting members (121 , 122) to move in unison with each other.
  • the movement may be driven, for example, by movement of the catheter (for example) of the second body (12) with respect to the first body (11). That movement may be manually driven by the operator.
  • each curved cutting member (121 , 122) may be provided with such a bridge member (14).
  • the bridge member (14) may be integrally formed with the curved cutting member (121 ,122) or may be secured thereto by welding or adhering.
  • the bridge member (14) may extend from the proximal end of the curved cutting member (121 , 122) and may - in versions including projection ⁇ ) (1215,1225) - extend further than the or each projection (1215, 1225).
  • the bridge member (14) may be attached to the other part (e.g. the catheter) of the second body (12).
  • the bridge member (14) may be adhered, welded, or overmoulded, for example, in place with respect to the other part (e.g. the catheter) of the second body (12).
  • the bridge member (14) may be formed from a different material compared to the curved cutting member (121 , 122) and/or may be biased differently from the curved cutting member (121 , 122). This may enable the bridge member (14) to enhance or provide the outward biasing of the curved cutting member to which it is secured.
  • the bridge member (14) is provided on an outer or may be on the inner surface of the curved cutting member (121 , 122) to which it is attached. In some versions the bridge member (14) is attached between the curved cutting member (121 ,122) and the other part (e.g. the catheter) of the second body (12) under tension, such that the bridge member (14) biases the curved cutting member (121 , 122) outwardly. This may be provided in addition to other arrangements to provide this bias, as described herein, or as the only arrangement to provide the bias.
  • the device (1) may further include an attachment ring (1217), which may be part of the second body (12) and which may be located between the other part of second body (12) (e.g. the catheter) and the curved cutting members (121 , 122).
  • the attachment ring (1217) may be configured to aid attachment between the other part (e.g. the catheter) of the second body (12) and the curved cutting members (121 , 122).
  • the one or more projections (1215, 1225) and/or one or more bridge members (14) may be attached (e.g. welded or adhered) to the attachment ring (1217) instead of the catheter of the second body (12) directly, for example.
  • the attachment ring (1217) may be formed from stainless steel or any other biocompatible material.
  • Figure 14D shows the attachment ring (1217) version of the technology for one of the curved cutting members (121). Accordingly, in manufacture, the curved cutting members (121 , 122) may be attached to the attachment ring (1217) and then the attachment ring (1217) may be attached to the catheter of the second body (12).
  • the curved cutting members (121 , 122) may be spaced in an equidistant manner about the circumference of the other part (e.g. catheter) of the second body (12). Therefore, any projections (1215,1225) and/or bridge members may also be spaced in an equidistant manner (or in groups (e.g. one group for each curved cutting member (121 , 122)) which are arranged in an equidistant manner) around the circumference of the other part (e.g. the catheter) of the second body (12). In other words, the groups may be equidistantly arranged but the projections (1215,1225) and/or bridge members may not necessarily be so arranged.
  • the distal portions (1213, 1223) of the curved cutting members (121 , 122) may have a larger diameter relative to the diameter of the proximal portions (1212, 1222) of the curved cutting members (121 , 122).
  • the distal portions (1212, 1222) of the curved cutting members (121 ,122) will be wider than the proximal portions (1212, 1222) of the curved cutting members (121 , 122).
  • the curved cutting members (121 , 122) may at least partially overlap each other.
  • the distal portions (1213, 1223) may at least partially overlap, with the second body (12) in the expanded configuration. This overlap may help to ensure that the curved cutting members (1212, 1222) correctly return to the collapsed configuration (e.g. when the other part (e.g. the catheter) of the second body (12) is retracted back into the first body (11)).
  • the proximal portions (1212, 1222) of the curved cutting members (121 , 122) remain within the lumen of the first body (11) with the second body (12) in the expanded configuration. This may help to keep the distal portions (1213, 1223) at least partially overlapping.
  • the fully extended configuration of the second body (12) is defined with the distal portions (1213, 1223) at the maximum extent of their outward movement whilst still at least partially overlapping.
  • this extension of the curved cutting members (121 , 122) may be at a maximum and so referred to as a maximum extension of the curved cutting members (121 , 122) - with the aforementioned distance referred to as maximum extension distance, for example.
  • the distal portions of the curved cutting members (121 , 122) may expand outwardly (i.e. radially outwardly) to a maximum diameter of about 1 ,5mm to about 25 mm and the at least one cutting edge (1211 , 1221) of each curved cutting member (121 , 122) may define a diameter which is less than the maximum diameter of the curved cutting members (121 , 122).
  • the diameter defined by the cutting edges (1211 , 1221) of the curved cutting members (122, 122) may be referred to as a cutting edge diameter (and the cutting edge diameter may be less than the maximum diameter of the curved cutting members (121 , 122).
  • the second body (12) may be expanded towards the expanded configuration until this curved or rounded surface abuts an internal surface of the hollow anatomic structure (3).
  • the curved or rounded surface may, therefore, be viewed as a abutment or seal surface.
  • the curved or rounded surface is provided by a curve of the curved cutting members (121 , 122), which may be bent to provide this surface.
  • the curved or rounded surface may be provided by a respective protrusion from the curved cutting members (121 , 122) - which may be integrally formed with the curved cutting member (121 , 122) or attached (e.g. by adhesion or welding) thereto.
  • this angle may likewise be defined between a diameter of the funnel at the curved or rounded surface (i.e. the abutment or seal surface) and the angle of the cutting edge (1211 , 1221). In which case, this angle may be from about 85 degrees to about 5 degrees (or to about 10 degrees, to about 15 degrees, to about 20 degrees, to about 25 degrees, to about 30 degrees, to about 35 degrees, to about 40 degrees, to about 45 degrees, to about 50 degrees, to about 55 degrees, to about 60 degrees, to about 65 degrees, to about 70 degrees, to about 75 degrees, or to about 80 degrees).
  • the interior and exterior surfaces (i.e. inner and outer surfaces) of the curved cutting members (121 , 122) may be smooth to facilitate the forward gliding, expansion and retraction of the curved cutting members (121 , 122).
  • the smooth interior surfaces of the curved cutting members (121 , 122) will also aid the flow of material (2) from the hollow anatomic structure (3) through the first and second bodies (11 ,12).
  • the curved cutting members (121 , 122) may be coated in a low friction material or finished (e.g. polished) to have a low coefficient of friction.
  • This coating or finish may be provided on the inner and/or outer surfaces of the curved cutting members (121 , 122), for example.
  • a low friction coating materials like hydrophilic or hydrophobic polymers which can be applied by dip or spry coating techniques. Examples of these biocompatible hydrophilic and hydrophobic materials are polyvinyl alcohol copolymers and polyfluorinated polymers respectively.
  • the device (1) may be include a membrane member (19).
  • the membrane member (19) may serve, for example, to reduce the size of or substantially block the gaps between the curved cutting members (121 , 122) at the proximal portions (1212, 1222) thereof.
  • the gaps between the proximal end Part of the curved cutting members (121 ,122) can be covered with smaller (self-expandable) covering curved cutting members (123, 124) on both outer or may be the inner sides of the gaps.
  • the smaller covering curved cutting members (124) is not showing in the figure.
  • the materials which these curved cutting members (123,124) are made from the same materials as the curved cutting leaves (121 ,122) or may be from any biocompatible elastic or self-expandable materials
  • slots or windows (1214, 1224) Whilst these slots or windows (1214, 1224) have been depicted in relation to, for example, a version with a triangular- or saw-tooth cutting edge, the slots or windows (1214, 1224) may be provided in relation to other versions described herein.
  • the gliding member (14) may be located on the external surface of the curved cutting member (121 , 122) (e.g. facing the hollow anatomic structure (3)).
  • the gliding member (14) may extend from the proximal portion (1212, 1222) of the curved cutting member (121 , 122) to the distal portion (1213, 1223) of the curved cutting member (121 , 122).
  • the gliding member (14) may be helping for the curved cutting member (121 , 122) to expand radially outwardly. In some versions of the technology, the gliding member (14) may be located on the internal surface of the curved cutting member (121 , 122)
  • the gliding member (14) may be welded onto the curved cutting member (121 , 122) or may be adhered thereto or may be integrally formed therewith.
  • the gliding member (14) may be a thicker (e.g. deeper) portion of the curved cutting member (121 ,122) running from the distal portion (1213,1223) to the proximal portion (1212, 1222) with a reduced thickness portion (relative to that of the gliding member (14)) of the curved cutting member (121 , 122) on one or both sides of the gliding member (14).
  • the distal portion (1213) of the curved cutting members (121) may expand radially outwardly to a maximum diameter from about 1 ,5mm to about 30mm or from about 3mm to about 30mm , or from 15mm to about 30mm, or from about 10mm to about 25mm.
  • the abutment or seal surface may abut the inner surface of the hollow anatomic structure (3) and may press against this surface, the form of the abutment or seal surface being such that the cutting edge or edges (1211
  • the device (1) may include an aspiration arrangement. This can aid the removal of the material (2) from the hollow anatomic structure (3) via the first and/or second body (11 , 12).
  • the aspiration arrangement may draw the material (3) out of the hollow anatomic structure (3).
  • the second body (12) ofthe device (1) may include the aspiration arrangement.
  • the aspiration arrangement may include an aspiration catheter and/or an aspiration pump.
  • the aspiration of the material (2) may continue until all or substantially all of the material (2) has been removed from the hollow anatomic structure (3).
  • the aspiration arrangement may include a vacuum aspiration arrangement.
  • the aspiration arrangement may be connected in fluid communication with the second body (12) and, in particular, may be connected in fluid communication with the lumen defined by the second body (12).
  • the aspiration arrangement may be connected in fluid communication with the volume defined by the funnel with the second body (12) in the expanded configuration.
  • the device (1) may further include a third body (15) configured to release fluid, for example, water, from the device (1) into the hollow anatomic structure (3) and/or into the volume defined by the funnel and/or into a volume defined by the other part of the second body (12) (e.g. the catheter of the second body (12)) .
  • the third body (15) may be arranged to extend through the first body and the second body (11 ,12).
  • the third body (15) my be in the form of a tube and may be a water jet catheter.
  • the third body (15) may be configured to release fluid in a direction which may be through the lumen of the second body (12) away from the curved cutting blades (121 ,122). The release of fluid in this manner may cause a Venturi effect and a pressure depression, which may result in the fluid and the material (2) being sucked into the second body (12) (for removal to outside the body of which the hollow anatomic structure (3) is a part).
  • the fluid may be water or a saline solution, for example.
  • the catheter which may be in the form of a tube for example, may be secured (e.g. by an adhesive or welding) or may be integrally formed within a wall of the other part of the second body (12) (e.g. the catheter).
  • the device (1) may further include a spiral drive member (16) configured to assist with the removal of the material (2) from the hollow anatomic structure (3).
  • the spiral drive member (16) may be rotated (e.g. through the use of a motor which may be attached to a proximal end of the spiral drive member
  • the spiral drive member (16) may be provided within a tube and/or may be located within the other part (e.g. the catheter) of the second body (12). In some versions, the spiral drive member (16) is generally centrally located within the other part (e.g. catheter) of the second body (12). A distal end of the spiral drive member (16) may be located adjacent the distal end of the other part (e.g. the catheter) of the second body (12).
  • the spiral drive member (16) or the tube in which the spiral drive member (16) may be located may be supported within the other part (e.g. catheter) of the second body (12) by one or more arms (which may be radially extending arms of the second body (12)).
  • the device (1) may further include an expandable pushing member (17) which may be in the form of an expandable stent (17) (such as a self-expandable stent) or an inflatable balloon, for example.
  • the expandable pushing member (17) may be received within the other part of the second body (12) (e.g. the catheter) and may be received by the lumen of the second body (12), for example.
  • the expandable pushing member (17) may have a collapsed state and an expanded state.
  • the expandable pushing member (17) may be provided through the second body (12) when the second body (12) is generally adjacent the material (2).
  • the expandable pushing member (17) may be in its collapsed state at this point and may be pushed through and/or around the material (2), such as by axial movement of the expandable pushing member 17 with respect to the second body (12) towards the material (2), before being controlled to adopt the expanded state. This may be achieved by moving a part of the expandable pushing member (17) out of a tube of the expandable pushing member (17), wherein that part is biased towards the expanded state and was restrained by the tube from adopting the expanded state.
  • a wire attached to a first part of the expandable pushing member (17) (and which may form another part of the expandable pushing member (17)) may be retracted to move a section of the first part of the expandable pushing member (17) towards another to cause adoption of the expandable pushing member (17).
  • a fluid such as water or saline solution
  • the expanded or inflated part of the expanded pushing member (17) may be retracted back towards to the second body (12) to assist in moving the material (2) into the funnel. This may be achieved by the retraction of the tube or a wire attached to the expanded or inflated part of the expanded pushing member (17), for example, with respect to the second body (12) (e.g. through the second body (12)).
  • the expandable pushing member (17) may be returned to or towards its collapsed state (e.g. by action of the second body (17) thereon as it is retracted) for removal with the device (1).
  • the material (2) may include thrombi, emboli, atherosclerosis, restenosis or tumours, or any combination thereof.
  • the hollow anatomic structure (3) may include a blood vessel, a stent or a synthetic graft.
  • Neointima refers to scar tissue that forms within hollow anatomic structures (3) such as blood vessels, for example as a result of vascular injury. Neointima can reduce the width of the blood vessels, leading to an increased likelihood of thrombus formation.
  • the material (2) may be a thrombus and the hollow anatomic structure (3) may be a stent or synthetic graft which has neointima formation.
  • the thrombus may be cut and removed from the stent or synthetic graft using the device (1) and the neointima may subsequently or concurrently be cut and removed from the stent or synthetic graft using the device (1).
  • both the thrombus and the neointima may be removed from a stent concurrently using the device (1), As shown in Figure 20, for example, the device (1) may cut and remove thrombus (21) as well as the new intima (22), within a blood vessel, stent (32) or graft.
  • the electrical conductors may be coupled in electrical communication with the or each cutting edge (1211 ,1221).
  • the electrical conductors may be coupled in electrical communication with an electrical power supply, for example.
  • the curved cutting members (121 , 122) may be formed from one or more different materials.
  • these materials include self-expandable metal constructs, elastic materials, shape memory materials, metal alloys or polymeric materials and any combination thereof.

Landscapes

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

Abstract

Dispositif médical (1) pour retirer un matériau (2) d'une structure anatomique creuse (3), le dispositif médical (1) comprenant : un premier corps (11) avec une lumière ; et un second corps (12) avec une lumière, le second corps étant allongé, le second corps possédant une configuration repliée et une configuration déployée et le second corps (12) comprenant des éléments de coupe incurvés (121, 122), sachant que, dans la configuration repliée, les éléments de coupe incurvés (121, 122) sont au moins partiellement conçus à l'intérieur du premier corps (11) et que, dans la configuration déployée, les parties distales (1213, 1223) des éléments de coupe incurvés (121, 122) glissent l'une sur l'autre pour se multiplier radialement vers l'extérieur à partir de leur position dans la configuration repliée, afin que le second corps (12) forme un entonnoir dans la configuration repliée et que le matériau entrant dans l'entonnoir soit dirigé à travers au moins l'une des lumières du premier corps (11) et la lumière du second corps (12), sachant que chaque élément de coupe incurvé (121, 122) possède un degré de courbure plus important au niveau de la partie distale qu'au niveau de la partie proximale.
PCT/EP2023/078357 2023-10-12 2023-10-12 Dispositif médical Pending WO2025078016A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2023/078357 WO2025078016A1 (fr) 2023-10-12 2023-10-12 Dispositif médical

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2023/078357 WO2025078016A1 (fr) 2023-10-12 2023-10-12 Dispositif médical

Publications (1)

Publication Number Publication Date
WO2025078016A1 true WO2025078016A1 (fr) 2025-04-17

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Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5152773A (en) 1988-09-09 1992-10-06 Falah Redha Medical instrument
US5725543A (en) 1993-03-11 1998-03-10 Redha; Falah Medical instrument for atherectomy
US5902313A (en) 1994-03-09 1999-05-11 Redha; Falah Medical instrument for atherectomy
US7645290B2 (en) 2005-05-05 2010-01-12 Lucas Paul R Multi-functional thrombectomy device
US8430881B2 (en) * 2004-10-15 2013-04-30 Baxano, Inc. Mechanical tissue modification devices and methods
US8506512B2 (en) 2007-12-20 2013-08-13 Angio Dynamics Systems and methods for removing undesirable material within a circulatory system utilizing a balloon catheter
WO2013135792A1 (fr) * 2012-03-14 2013-09-19 Universite Catholique De Louvain Dispositif d'excision de valvule cardiaque
US8795304B2 (en) 2009-06-18 2014-08-05 Cardiovascular Systems, Inc. Atherectomy device, system and method having a bi-directional distal expandable ablation element
US20160270810A1 (en) * 2014-06-13 2016-09-22 InterShunt Technologies, Inc. Method and catheter for creating an interatrial aperture
WO2016154170A1 (fr) * 2015-03-26 2016-09-29 SPIRATION, INC., d/b/a OLYMPUS RESPIRATORY AMERICA Mécanisme de rétention d'échantillon de biopsie
US9775636B2 (en) * 2013-03-12 2017-10-03 Corvia Medical, Inc. Devices, systems, and methods for treating heart failure
US20170303949A1 (en) 2015-01-13 2017-10-26 Anaconda Biomed, S.L. Thrombectomy device, system and method for extraction of vascular thrombi from a blood vessel
WO2023172760A1 (fr) * 2022-03-10 2023-09-14 Intervene, Inc. Systèmes d'intervention et dispositifs et procédés associés

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5152773A (en) 1988-09-09 1992-10-06 Falah Redha Medical instrument
US5282813A (en) 1988-09-09 1994-02-01 Falah Redha Surgical apparatus for removal of deposits from vessels
US5725543A (en) 1993-03-11 1998-03-10 Redha; Falah Medical instrument for atherectomy
US5902313A (en) 1994-03-09 1999-05-11 Redha; Falah Medical instrument for atherectomy
US8430881B2 (en) * 2004-10-15 2013-04-30 Baxano, Inc. Mechanical tissue modification devices and methods
US7645290B2 (en) 2005-05-05 2010-01-12 Lucas Paul R Multi-functional thrombectomy device
US8506512B2 (en) 2007-12-20 2013-08-13 Angio Dynamics Systems and methods for removing undesirable material within a circulatory system utilizing a balloon catheter
US8795304B2 (en) 2009-06-18 2014-08-05 Cardiovascular Systems, Inc. Atherectomy device, system and method having a bi-directional distal expandable ablation element
WO2013135792A1 (fr) * 2012-03-14 2013-09-19 Universite Catholique De Louvain Dispositif d'excision de valvule cardiaque
US9775636B2 (en) * 2013-03-12 2017-10-03 Corvia Medical, Inc. Devices, systems, and methods for treating heart failure
US20160270810A1 (en) * 2014-06-13 2016-09-22 InterShunt Technologies, Inc. Method and catheter for creating an interatrial aperture
US20170303949A1 (en) 2015-01-13 2017-10-26 Anaconda Biomed, S.L. Thrombectomy device, system and method for extraction of vascular thrombi from a blood vessel
WO2016154170A1 (fr) * 2015-03-26 2016-09-29 SPIRATION, INC., d/b/a OLYMPUS RESPIRATORY AMERICA Mécanisme de rétention d'échantillon de biopsie
WO2023172760A1 (fr) * 2022-03-10 2023-09-14 Intervene, Inc. Systèmes d'intervention et dispositifs et procédés associés

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