WO2025051366A1 - Dispositif médical de blocage d'un vaisseau - Google Patents
Dispositif médical de blocage d'un vaisseau Download PDFInfo
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- WO2025051366A1 WO2025051366A1 PCT/EP2023/074604 EP2023074604W WO2025051366A1 WO 2025051366 A1 WO2025051366 A1 WO 2025051366A1 EP 2023074604 W EP2023074604 W EP 2023074604W WO 2025051366 A1 WO2025051366 A1 WO 2025051366A1
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- Prior art keywords
- medical device
- plug
- locking
- catheter
- elongate member
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/12—Surgical instruments, devices or methods for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels or umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12099—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder
- A61B17/12109—Occluding by internal devices, e.g. balloons or releasable wires characterised by the location of the occluder in a blood vessel
-
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
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- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
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- A61B17/1215—Coils or wires comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
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- A61B17/12131—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device
- A61B17/12168—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure
- A61B17/12172—Occluding by internal devices, e.g. balloons or releasable wires characterised by the type of occluding device having a mesh structure having a pre-set deployed three-dimensional shape
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- A61B2017/12086—Details concerning the detachment of the occluding device from the introduction device magnetically detachable
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- A61M25/00—Catheters; Hollow probes
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- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/1054—Balloon catheters with special features or adapted for special applications having detachable or disposable balloons
Definitions
- the present disclosure relates to medical devices for blocking and collapsing a blood vessel and medical device for blocking fluid flow through a vessel .
- Medical devices for restricting or blocking a vessel can be used in the treatment of a number of medical conditions which require blood flow through a blood vessel to be restricted or blocked .
- the blood vessel through which the flow of blood is to be restricted or blocked may be a vein .
- CVI Chronic Venous Insuf ficiency
- Such valve damage may occur as the result of aging, extended sitting or standing, or a combination of aging and reduced mobility .
- CVI may be treated by inserting a medical device into a damaged vein in order to block the flow of blood through that vein and thereby close that vein .
- collapsing the vein may result in improved restriction of blood flow through the vein . This will result in blood flow being rerouted to nearby healthy veins instead .
- the blood vessel through which the flow of blood is to be restricted or blocked may be an artery .
- the arteries feeding blood to the tumour may be blocked or restricted with a medical implant to starve the tumour o f blood, also known as tumor embolization .
- An abdominal aortic aneurysm (AAA) is a swelling or bulge in the aorta which can cause li fe-threatening bleeding i f it ruptures .
- Medical devices or implants may be inserted into arteries which feed the aneurysm in order to stop the flow of blood into the aneurysm .
- Such medical devices may also be utili zed in other medical procedures such as balloon-occluded retrograde transvenous obliteration (BRTO) , or as preparation for large vital organ or tissue resections .
- BRTO balloon-occluded retrograde transvenous obliteration
- these devices can suf fer from drawbacks such as migration, lack of control over the deployment of the device , and unsatis factory blocking or occlusion of the vessel .
- a medical device for blocking and collapsing a blood vessel .
- the medical device comprises a first catheter having a first plug positioned at a distal end thereof , wherein the first plug is an expandable plug and is detachable from the first catheter, and a second catheter having a second plug positioned at a distal end thereof , wherein the second plug is detachable from the second catheter .
- the first catheter is longitudinally moveable relative to the second catheter, and one of the first catheter or the second catheter comprises a suction lumen . In some embodiments , this may result in a medical device which can ef fectively collapse and block a blood vessel .
- suction lumen' is used to refer to a lumen of a catheter which is adapted for aspirating a fluid .
- the first catheter may be positioned at least partially within the second catheter .
- this may allow the first catheter to ef fectively move longitudinally relative to the second catheter .
- the first catheter may comprise the suction lumen .
- the first catheter may comprise a rigid ring at its distal end, proximally of the first plug .
- this may prevent the first catheter from collapsing during aspiration of the blood vessel .
- the rigid ring may be radiopaque .
- this may allow the position of the first plug and first catheter to be detected under fluoroscopy and thereby result in more accurate positioning of the medical device .
- the first expandable plug may have a radially collapsed configuration and a radially expanded configuration .
- the second plug may be an expandable plug and may have a radially collapsed configuration and a radially expanded configuration . In some embodiments , this may result in improved sealing between the second plug and the blood vessel .
- the first expandable plug, or the second expandable plug, or both the first and second expandable plugs may comprise a sel f-expanding mesh .
- this may provide for a simple and ef fective way to expand the first expandable plug and/or the second expandable plugs .
- the sel f-expanding mesh may be made from a shape memory material .
- the sel f-expanding mesh may be made from nitinol .
- the sel f-expanding mesh may be folded .
- this may allow the diameter of the first plug and/or the second plug to be reduced for improved passage and advancement through the vessel anatomy .
- the first expandable plug, or the second expandable plug, or both the first and second expandable plugs may further comprise a membrane .
- this may result in improved blocking or occluding of the vessel .
- the first expandable plug and/or the second expandable plug comprises one or more outer expandable rings and one or more membranes attached to the one or more outer expandable rings .
- this may provide for a simple and ef fective way to expand the first expandable plug and/or the second expandable plugs .
- the first expandable plug, or the second expandable plug, or both the first and the second expandable plugs may comprise a plurality of outer expandable rings arranged longitudinally and a plurality of membranes attached to the expandable rings .
- this may result in improved blocking or occluding of the vessel .
- the one or more outer expandable rings may be sel f-expanding rings .
- the sel f-expanding rings may be made from a shape-memory material .
- the sel f-expanding rings may be made from nitinol .
- the one or more outer expandable rings may be folded radially inwards to form a star shape .
- this may allow the diameter of the first and/or second plug to be reduced for improved passage and advancement through the vessel anatomy .
- the membrane may be made from PTFE .
- this may result in improved blocking or occluding of the vessel .
- the first expandable plug, or the second expandable plug, or both the first and the second expandable plugs may comprise a compressible material .
- Longitudinally compressing the compressible material may move the first expandable plug, or the second expandable plug, or both the first and the second expandable plug from the radially collapsed configuration to the radially expanded configuration .
- this may provide for a simple and ef fective way to expand the first and/or second expandable plugs .
- the first expandable plug, or the second expandable plug, or both the first and the second expandable plug may comprise a proximal plate and a distal plate positioned on opposite sides of the compressible material and a screw mechanism for compressing the compressible material between the proximal plate and the distal plate .
- the first expandable plug, or the second expandable plug, or both the first and the second expandable plugs may comprise an inflatable balloon having a one-way valve .
- this may allow the inflatable balloon to remain inflated when detached from the catheter .
- the first expandable plug and the second expandable plug may be made from a bioresorbable material .
- this may allow the first and second expandable plugs to remain in the body .
- the medical device may further comprise a vacuum pump connected to a proximal end of the suction lumen .
- this may provide an ef fective way to aspirate the blood vessel through the suction lumen .
- the medical device may further comprise a first detachment mechanism between the first plug and the first catheter .
- the first detachment mechanism may comprise a screw mechanism or a locking tab mechanism .
- this may provide an ef fective mechanism for detaching the first plug from the first catheter .
- the medical device may comprise a second detachment mechanism between the second plug and the second catheter .
- the second detachment mechanism may comprise a screw mechanism or a locking tab mechanism .
- this may provide an ef fective mechanism for detaching the second plug from the second catheter .
- a medical device for blocking fluid flow through a vessel .
- the medical device may comprise : an elongate member ; a plurality of longitudinally arranged fibers positioned around the elongate member, the plurality of longitudinally arranged fibers fixed to a distal end of the elongate member ; and one or more longitudinally moveable locking elements , each having an unlocked configuration and a locked configuration .
- the locking element In the unlocked configuration the locking element is longitudinally moveable relative to the longitudinally arranged fibers
- the locked configuration the locking element is locked to the longitudinally arranged fibers and configured to move the longitudinally arranged fibers relative to the flexible elongate member .
- this may result in a medical device which can be accurately positioned and deployed in a more controlled manner to ef fectively block fluid flow through a vessel or isolate a speci fic section of a vessel . In some embodiments , this may also result in a medical device which can be used in a number of vessels with di f ferent diameters to ef fectively block fluid flow through the vessel .
- the elongate member may be a wire or shaft .
- the longitudinally arranged fibers may comprise nitinol .
- this may allow the fibers to ef fectively deform and block fluid flow through the vessel .
- the one or more locking elements may be positioned around the plurality of longitudinally arranged fibers .
- the one or more locking elements may be moved between the locked configuration and the unlocked configuration by rotation .
- this may provide for a simple and ef fective way to move the locking elements between the locked configuration and the unlocked configuration .
- the one or more locking elements may each comprise a locking ring .
- the locking ring may have an inner surface comprising longitudinally arranged grooves or ridges for engaging the plurality of longitudinally arranged fibers .
- this may provide an ef fective way for the locking elements to be locked to the longitudinally arranged fibers in the locked configuration .
- the locking ring may comprise a plurality of holes for the plurality of longitudinally arranged fibers to pass through . In some embodiments , this may provide an ef fective way for the locking elements to be locked to the longitudinally arranged fibers in the locked configuration .
- the locking ring may comprise a central hole for the elongate member to pass through and the plurality of holes may be circumferentially positioned around the central hole .
- this may provide an ef fective way for the locking elements to be locked to the longitudinally arranged fibers in the locked configuration and moveable relative to the elongate member .
- the locking ring may have an outer surface with longitudinally arranged locking features for engaging corresponding locking features on a locking shaft .
- this may allow the locking elements to be ef fectively moved longitudinally and rotated by a locking shaft .
- the locking features may comprise longitudinally arranged grooves , ridges or protrusions .
- this may allow the locking elements to be ef fectively moved longitudinally and rotated .
- the wedge-shapes protrusions may provide ef fective longitudinal and circumferential engagement with protrusions of the locking shaft to provide ef fective longitudinal and rotational movement of the locking elements .
- the medical device may further comprise a locking shaft having locking features for engaging the one or more locking elements .
- the locking shaft may be positioned around the elongate member and the plurality of longitudinally arranged fibers and may be longitudinally moveable relative to the elongate member and the plurality of longitudinally arranged fibers .
- the locking features of the locking shaft may be configured to engage corresponding locking features on the locking element to move the locking element longitudinally and rotate the locking element to move the locking element between the unlocked and locked configuration .
- the locking features of the locking shaft may comprise radially inwardly extending grooves , ridges or protrusions .
- this may allow the locking shaft to longitudinally move the locking elements as well as rotate the locking elements to move them between the locked and the unlocked configuration .
- the locking features of the locking shaft may comprise longitudinally arranged grooves , ridges or protrusions .
- this may allow the coil to ef fectively move between the radially contracted configuration and the radially expanded configuration and provide ef fective occlusion of the vessel in the radially expanded configuration .
- the one or more coils may be made from nitinol , stainless steel or a polymer .
- this may provide ef fective occlusion of the vessel in the radially expanded configuration .
- Each of the one or more coils may be covered with a membrane .
- this may result in improved occlusion of the vessel .
- the membrane may be made from PTFE .
- the medical device may further comprise a first membrane positioned at a proximal end of the coil and a second membrane positioned at a distal end of the coil .
- this may result in improved occlusion of the vessel .
- the first membrane , or the second membrane , or both the first membrane and the second membrane may be made from PTFE .
- the medical device may comprises a control shaft attached to the coil stopper for longitudinally moving the coil stopper relative to the first elongate member .
- the first elongate member may be positioned within the control shaft or the control shaft may be positioned within the first elongate member .
- the one or more coils may comprise a first coil and a second coil positioned proximally of the first coil .
- this may provide for better occlusion of the vessel . In some embodiments , this may further allow a section of the vessel to be isolated .
- the medical device may further comprise a radiopaque marker or ultrasound marker positioned at a distal end of each of the one or more coils .
- this may allow for more accurate positioning of the medical device .
- the medical device may be configured to be removably attached to a catheter .
- this may allow the medical device to be used as a medical implant and remain in the body .
- the medical device may further comprise a screw mechanism at a proximal end for removably attaching to the catheter .
- this may provide a simple and ef fective way to detach the medical device from the catheter .
- FIG . 1 shows a device for blocking and collapsing a blood vessel according to one or more embodiments of the disclosure .
- FIGS . 2A to 2 F illustrate a method of using the device of FIG . 1 to block and collapse a vein .
- FIGS . 3A and 3B illustrate an embodiment of an expandable plug of the device of FIG . 1 in a radially collapsed configuration and a radially expanded configuration .
- FIGS . 4A and 4B illustrate another embodiment of the expandable plug of the device of FIG . 1 in a radially collapsed configuration and a radially expanded configuration .
- FIGS . 5A to 5C show a cross-sectional view of the expandable plug of FIGS . 4A and 4B in the radially expanded configuration, during the collapsing step, and in the radially collapsed configuration .
- FIGS . 6A to 6C show cross-sectional views of another embodiment of an expandable plug of the device of FIG . 1 in the radially expanded configuration, during the collapsing step, and in the radially collapsed configuration .
- FIGS . 7A and 7B illustrate an embodiment of a detachment mechanism for detaching the expandable plug of the device o f FIG . 1 .
- FIGS . 8A and 8B illustrate another embodiment of a detachment mechanism for detaching the expandable plug of the device o f FIG . 1 .
- FIGS . 9A and 9B shows a cross-sectional view of the detachment mechanism of FIG . 8A and 8B .
- FIGS . 10A to 10G show another device for blocking a vessel according to one or more embodiments of the disclosure , and illustrate a method of using the device to block a vessel .
- FIGS . 11A and 11B show cross-sectional views of an embodiment of the locking element of the device of FIGS . 10A to 10G in an unlocked configuration and a locked configuration .
- FIGS . 12A and 12B show cross-sectional views of another embodiment of the locking element of the device of FIGS . 10A to 10G in an unlocked configuration and a locked configuration .
- FIGS . I SA and 13B show cross-sectional views of the locking element of FIGS . 12A and 12B and a locking shaft in an unlocked configuration and a locked configuration .
- FIGS . 14A to 14C show another device for blocking a vessel in a radially contracted configuration and a radially expanded configuration, according to one or more embodiments of the disclosure .
- FIGS . 15A and 15B show another device for blocking a vessel in a radially contracted conf iguration and a radially expanded configuration, according to one or more embodiments of the disclosure .
- FIG . 1 shows a medical device 100 for blocking blood flow through a blood vessel and collapsing a blood vessel .
- the medical device includes a first catheter 110 and a first plug 120 positioned at a distal end of the first catheter 110 , with the first plug 120 being detachable from the first catheter 110 .
- the medical device 100 further includes a second catheter 130 and a second plug 140 positioned at the distal end of the second catheter 130 , with the second plug 140 being detachable from the second catheter 130 .
- the first plug 120 is expandable and may have a radially collapsed configuration and a radially expanded configuration . In the radially expanded configuration, the radial extent of the first plug is greater than in the radially collapsed configuration .
- the second plug 140 may also be expandable and may similarly have a radially collapsed configuration and a radially expanded configuration .
- the first catheter 110 and first plug 120 are longitudinally moveable relative to the second catheter 130 and second plug 140 .
- the first catheter 110 may be positioned within a lumen of the second catheter 130 and may be longitudinally moveable therein .
- the first catheter 110 has a suction lumen 111 for aspirating a blood vessel .
- the first catheter 110 may further comprise a rigid ring 150 positioned at a distal end of the first catheter 110 proximal of the first plug 120 .
- the rigid ring 150 may provide structural stability to the distal end of the first catheter 110 to prevent the first catheter 110 and the suction lumen 111 from collapsing during aspiration of a blood vessel .
- the rigid ring 150 may further be made from a radiopaque material , such as platinum-iridium, gold or tantalum, for example . This allows the distal end of the first catheter 110 to be detected and viewed under fluoroscopy to allow for accurate positioning of the medical device 100 in the blood vessel .
- a vacuum pump (not shown) may be connected to the proximal end of the suction lumen 111 and may provide negative pressure or a vacuum to the suction lumen 111 to allow the suction lumen 111 to aspirate a blood vessel .
- the first expandable plug 120 may comprise , for example , an inflatable balloon with a one-way valve , a compressible material which expands radially when compressed longitudinally, a sel f-expanding mesh, or a plurality o f expanding rings with a membranes .
- the second plug 140 may also be expandable and comprise , for example , an inflatable balloon with a one-way valve , a compressible material which expands radially when compressed longitudinally, a sel fexpanding mesh, or a plurality of expanding rings with membranes .
- the second plug 140 may be non-expandable .
- the first plug 120 and the second plug 140 may be made from a bioresorbable material which can degrade and be absorbed into the tissue of a patient over time .
- suitable bioresorbable materials include Poly ( 4- Hydroxybutyrate ) ( P4BH) or Poly ( lactic-co-glycolic acid) ( PLGA) .
- FIGS . 2A to 2 F illustrate a method of using the medical device 100 to collapse a blood vessel and block the flow o f fluid through the blood vessel .
- the blood vessel is a vein V and the medical device 100 may be used to treat a varicose vein, for example .
- the medical device 100 may similarly be used to treat an artery .
- the second plug 140 is then positioned at the other end o f the treatment site by moving the second catheter 130 relative to the first catheter 110 .
- the second plug 140 may be expanded from the radially collapsed configuration to the radially expanded configuration such that it engages the wall of the vein V and forms a seal therewith .
- the first catheter 140 is then detached from the first plug 120 and retracted such that the distal end of the first catheter 110 is positioned j ust distally of the second plug 140 .
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Abstract
L'invention concerne un dispositif médical pour bloquer et affaisser un vaisseau sanguin. Le dispositif médical comprend un premier cathéter ayant un premier bouchon positionné au niveau d'une extrémité distale de celui-ci, le premier bouchon étant un bouchon expansible et étant détachable du premier cathéter, et un second cathéter ayant un second bouchon positionné au niveau d'une extrémité distale de celui-ci, le second bouchon étant détachable du second cathéter. Le premier cathéter est mobile longitudinalement par rapport au second cathéter, et l'un du premier cathéter ou du second cathéter comprend une lumière d'aspiration.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2023/074604 WO2025051366A1 (fr) | 2023-09-07 | 2023-09-07 | Dispositif médical de blocage d'un vaisseau |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/EP2023/074604 WO2025051366A1 (fr) | 2023-09-07 | 2023-09-07 | Dispositif médical de blocage d'un vaisseau |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025051366A1 true WO2025051366A1 (fr) | 2025-03-13 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2023/074604 Pending WO2025051366A1 (fr) | 2023-09-07 | 2023-09-07 | Dispositif médical de blocage d'un vaisseau |
Country Status (1)
| Country | Link |
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| WO (1) | WO2025051366A1 (fr) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2431594A1 (fr) * | 2000-10-24 | 2002-09-12 | Martin Dieck | Dispositifs et procedes servant a traiter des malformations vasculaires |
| EP1768626B1 (fr) * | 2004-06-10 | 2012-08-22 | Conceptus, Inc. | Dispositifs medicaux et leurs procedes de production et d'utilisation |
| US20180028206A1 (en) * | 2015-04-10 | 2018-02-01 | Vimal Nanavati | Multi-Lumen Catheter for Cardiac Device Deployment |
| EP3470016A1 (fr) * | 2013-03-15 | 2019-04-17 | Metactive Medical, Inc. | Dispositif de corps expansible |
| US20210401597A1 (en) * | 2020-06-29 | 2021-12-30 | Neuravi Limited | Isolated stenting with distal self-expanding occlusion |
| WO2023051919A1 (fr) * | 2021-09-30 | 2023-04-06 | Clearstream Technologies Limited | Système d'embolisation |
-
2023
- 2023-09-07 WO PCT/EP2023/074604 patent/WO2025051366A1/fr active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CA2431594A1 (fr) * | 2000-10-24 | 2002-09-12 | Martin Dieck | Dispositifs et procedes servant a traiter des malformations vasculaires |
| EP1768626B1 (fr) * | 2004-06-10 | 2012-08-22 | Conceptus, Inc. | Dispositifs medicaux et leurs procedes de production et d'utilisation |
| EP3470016A1 (fr) * | 2013-03-15 | 2019-04-17 | Metactive Medical, Inc. | Dispositif de corps expansible |
| US20180028206A1 (en) * | 2015-04-10 | 2018-02-01 | Vimal Nanavati | Multi-Lumen Catheter for Cardiac Device Deployment |
| US20210401597A1 (en) * | 2020-06-29 | 2021-12-30 | Neuravi Limited | Isolated stenting with distal self-expanding occlusion |
| WO2023051919A1 (fr) * | 2021-09-30 | 2023-04-06 | Clearstream Technologies Limited | Système d'embolisation |
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