US20150343181A1 - Occlusion device and methods of using the same - Google Patents
Occlusion device and methods of using the same Download PDFInfo
- Publication number
- US20150343181A1 US20150343181A1 US14/293,536 US201414293536A US2015343181A1 US 20150343181 A1 US20150343181 A1 US 20150343181A1 US 201414293536 A US201414293536 A US 201414293536A US 2015343181 A1 US2015343181 A1 US 2015343181A1
- Authority
- US
- United States
- Prior art keywords
- occlusion
- occlusion device
- proximal
- distal
- occluding
- 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.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1002—Balloon catheters characterised by balloon shape
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B17/12027—Type of occlusion
- A61B17/12031—Type of occlusion complete occlusion
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B2017/00831—Material properties
- A61B2017/00853—Material properties low friction, hydrophobic and corrosion-resistant fluorocarbon resin coating (ptf, ptfe, polytetrafluoroethylene)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- 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, e.g. tourniquets
- 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, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
- A61B2017/1205—Introduction devices
- A61B2017/12054—Details concerning the detachment of the occluding device from the introduction device
-
- 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
- A61B2090/3966—Radiopaque markers visible in an X-ray image
Definitions
- the present invention generally relates to embolization or occlusion devices for the human and animal body.
- An embolization or occlusion device can be placed within the lumen or interior space of an organ or physiological conduit including arteries, veins, vessels, the bilary tree, the urinary tract, the alimentary tract, the tracheobronchial tree, the genitourinary system, and the cerebral aqueduct.
- Occlusion devices are used for a number of different purposes, all with the common feature that it is desired to limit or stop the free flow of fluid or blood in an area of the body.
- An endovascular field of application for occlusion devices for percutaneous, transluminal insertion using minimally invasive techniques is occlusion of an aneurism to prevent rupture of the vessel wall with resulting bleeding.
- Other applications include occlusion or treatment of varicose veins, occlusion of arteriovenous malformations (AVM), blocking of the blood flow to a tumor, and/or closure of traumatically conditioned blood flows caused by wounds, bodily injuries or gastrointestinal bleeding.
- AVM arteriovenous malformations
- Occlusion devices can be used in many different places in the vascular system and in vessels of differing sizes and geometries. Therefore, many different occlusion devices have been designed with various basic predetermined shapes and of varying sizes. Conventionally, the predetermined shape of the occlusion device is made so that the body of the device has a diameter of the same size or slightly larger than the relevant vessel lumen, so that the body of the device exerts an abutment pressure against the vessel wall. When it is desirable to quickly occlude a blood vessel, an inflatable balloon may be temporarily used.
- Another example of a more permanent occlusion device includes embolization coils, which may promote blood clots or tissue growth over a period of time, thereby occluding the body cavity and/or vessel lumen. Occlusion devices having other shapes and structures may also be used as necessary or desired, including but not limited to barrels, disks, wires and/or fibers.
- a delivery assembly including a guidewire and a catheter may be placed transluminally in the vascular system having its distal catheter end at the site of placement.
- the occlusion device When the occlusion device leaves the distal end of the catheter, it seeks to assume a predetermined shape within the vessel or alternatively, it can be mechanically expanded within the vessel. If the size and shape of the device are deemed suitable for the vessel geometry at the site of placement, the occlusion device is disconnected from the components of the delivery assembly and the assembly removed from the vasculature.
- Disclosed herein is an improved occlusion device for occluding a body lumen and/or vessel. Also disclosed is a delivery assembly and methods for placing and retrieving an occlusion device within a body vessel.
- an occlusion device for occluding a body lumen.
- the occlusion device comprises a proximal end, a distal end spaced from the proximal end along a longitudinal axis, and an occluding member disposed between the proximal end and distal end.
- the occluding member has a radially-outwardly expanded configuration and a contracted configuration.
- At least one biasing member is disposed within the occluding member and extends between the proximal and distal ends along a longitudinal axis, the biasing member having a contracted configuration and an extended configuration. When the occlusion member is in the expanded configuration the biasing member is in the contracted position and when the occlusion member is in the contracted configuration the biasing member is in the extended position.
- the occlusion device comprises a proximal end, a distal end spaced from the proximal end along a longitudinal axis and an occluding member disposed between the proximal end and distal end.
- the occluding member has a radially-outwardly expanded configuration and a contracted configuration.
- a first biasing member is disposed within the occluding member having a first end adjoined to the proximal end of the device, and a second biasing member is disposed within the occluding member having a first end adjoined to the distal end of the device.
- the second biasing member is configured to releasably engage the first biasing member.
- FIG. 1 is a partial section of a body vessel including one example of an occlusion device in a radially expanded deployed configuration therein.
- FIG. 2 is a partial section of the occlusion device of FIG. 1 in a collapsed delivery configuration within an outer sheath and a distal portion of one example of a delivery assembly.
- FIG. 3 is a partial section of another example of an occlusion device in a collapsed delivery configuration within an outer sheath and a distal portion of one example of a delivery assembly.
- FIG. 4 is a partial section of a body vessel including another example of an occlusion device in a radially expanded deployed configuration therein.
- FIG. 5 is a side view of one example of a delivery and retrieval assembly for use with an occlusion device.
- FIG. 6 is an exploded view of the delivery and retrieval assembly of FIG. 5 .
- FIG. 7 illustrates one example of the distal end of the a delivery device engaged with the occlusion device within a delivery sheath.
- FIG. 8 illustrates one example of a delivery sheath partially withdrawn and the distal end of a delivery device disengaged from the occlusion device.
- proximal and distal are used to refer to a position or direction towards the patient's heart and the terms “distal” and “distally” are used for a position or direction away the patient's heart when describing an occlusion device.
- downstream refers to the direction further from the heart
- upstream refers to the direction closer to the heart.
- proximal and distal when used herein in relation to instruments used in the procedure, such as a delivery assembly, delivery device, catheter, guide wire and the like, refer to directions closer to and farther away from the operator performing the procedure. Thus, a distal end of a delivery catheter or guide wire would be farther away from the operator, while the proximal end of a delivery catheter or guide wire would be closer to the operator.
- the occlusion device 10 includes a first or proximal hub 12 extending from a proximal end 14 to a distal end 16 and along a longitudinal axis 18 with a tubular wall 20 optionally defining a lumen 22 .
- a proximal end 26 of an occluding member 24 is attached to the proximal hub 12 and extends distally therefrom for attachment at its distal end 28 to a second or distal hub 30 .
- Distal hub 30 has a proximal end 32 and a distal end 34 , with a tubular wall 36 optionally defining a second lumen 38 .
- the occluding member 24 may define an interior volume or space 40 .
- at least a portion of member 24 forms an occlusive barrier when deployed within a body lumen and/or vessel 42 .
- occlusion member 24 may extend between the distal end 16 of the first (proximal) hub 12 and a proximal end 32 of the second (distal) hub 30 .
- a middle portion 44 of the occluding member 24 extends radially away from the longitudinal axis 18 when the device 10 is in an open configuration to form a wider diameter portion 46 .
- the wider diameter portion 46 of the occlusion member 24 is generally centered or formed within a middle section 44 of occluding member 24 , but alternatively, the wider diameter portion 46 may be off-center, such that it is located closer to one hub or the other as needed, depending, for example, on the particular use of the device 10 or the patient's unique anatomy.
- the wider diameter portion 46 extends radially outwardly for a wide enough distance so that at least a portion of the occlusion member 24 is substantially adjacent to and/or abuts the vessel wall when the device 10 is deployed within the body vessel 42 as shown in FIG. 1 and FIG. 4 .
- at least part of the occlusion member 24 such as wider diameter portion 46 , extends outwardly from the longitudinal axis 18 and achieves sufficient radial force against at least a portion of the vessel wall to hold and/or secure the device 10 in place so that risk of dislodgment and/or migration of the device 10 is substantially reduced or otherwise eliminated.
- the radially outward expansion of the device upon delivery and deployment is described in further detail below.
- the occlusion member 24 may taper radially inwardly from the wider diameter portion 46 to a more narrow diameter portions 48 , 50 at each of the respective proximal and distal ends 26 , 28 .
- the more narrow diameter portions 48 , 50 may be attached to one or both of the respective hubs 12 , 30 by various attachment means, including welding, adhesive, glue, friction fit or similar attachment members (e.g., screws, threads) or alternatively, member 24 may be integrally formed with one or both of the hubs 12 , 30 . As illustrated in FIG.
- the proximal and/or distal ends 26 , 28 of the occlusion member 24 may be crimped down or otherwise contracted radially inwardly so that they can be held by, inserted into or otherwise retained within the respective proximal and distal hubs 12 , 30 .
- the occlusion member 24 and/or one or both of hubs 12 , 30 may include anchoring members (not shown).
- the anchoring members may have any appropriate shape to keep the device 10 from moving or migrating within the body vessel 42 .
- the anchoring members may include a plurality of barbs.
- Other examples of the anchoring members may include hooks, roughened surfaces or other similar structures that may engage the vessel wall and serve to prevent migration or dislodgement of the device 10 after deployment in the vessel 42 .
- One or both of the proximal and/or distal hubs 12 , 30 may be formed at least partially from a radiopaque material, including, but not limited to stainless steel and/or gold, and/or radiopaque polymers or alloys or include one or more radiopaque markers to enhance visibility and placement during delivery, such as with a fluoroscope.
- a radiopaque material including, but not limited to stainless steel and/or gold, and/or radiopaque polymers or alloys or include one or more radiopaque markers to enhance visibility and placement during delivery, such as with a fluoroscope.
- one or both of the hubs 12 , 30 may be formed from a stainless steel cannula having a size in the range of about 0.300 mm to about 1.100 mm and preferably about 0.899 mm. As shown in FIGS.
- one or both of the hubs 12 , 30 and preferably the proximal hub 12 may include a rounded or smooth atraumatic tip 52 placed thereon.
- the atraumatic tip 52 is formed in a bullet-nose shape, but may also include other domed, smooth or rounded shapes.
- the atraumatic tip 52 may either be removably secured to the proximal hub 12 to aid in the placement and delivery of the device 10 in a desired location within a vessel or body lumen, after which time the tip 52 may be removed from the device 10 during and/or after deployment.
- the atraumatic tip 52 may be permanently secured to the proximal hub 12 such that it remains secured to the device 10 when it is deployed within a vessel 42 , or, in yet another alternative, the proximal hub 12 itself may be atraumatically shaped, smooth and/or rounded.
- An atraumatically shaped hub 12 and/or atraumatic tip 52 may facilitate the ease of delivery and placement of the device 10 in tortuous anatomy while also reducing or eliminating vessel damage or injury.
- the occluding member 24 may be a variety of structures including, but not limited to, one or more wires, coils, fabrics, fibers, flexible arcuate members, cages, screens, disks, walls and the like and may be constructed or formed from a single material or, alternatively, may be formed from a variety or combination of materials.
- at least a portion of occlusion member 24 may be formed of any suitable material that may be expanded, such as by mechanical expansion.
- at least a portion of the occlusion member may be formed from any suitable material that will result in a self-opening or self-expanding device 10 , such as shape memory material.
- Shape memory material that is heated (or cooled) above (or below) a transition temperature causes the material to undergo a phase transformation such that the material returns to its “remembered” state.
- a transition temperature causes the material to undergo a phase transformation such that the material returns to its “remembered” state.
- the device 10 when the device 10 is deployed in a body vessel 42 having a particular temperature the device 10 will transform to the remembered (expanded) state within the vessel 42 .
- it may be cooled (or, alternatively heated) to transform the material to a more malleable state, such that the device 10 can be more easily collapsed and pulled into a lumen of a catheter (re-sheathed) for removal.
- One shape memory alloy suitable for the present invention is Ni—Ti, also known as nitinol.
- occlusion member 24 is preferably formed of a woven mesh constructed of nitinol wire and a polyester fiber (polyethylene terephthalate commonly abbreviated PET, PETE) or referred to by the trade name Dacron®.
- the nitinol and polyester fiber mesh may be woven in any suitable combination or ratio, and in one example, the materials may be woven together in a ratio of 1:1 to form a mesh.
- the polyester fibers may act as a thrombogenic agent upon delivery and nesting of the device in a vessel 42 or body lumen.
- the occlusion member 24 may also be at least partially constructed of materials such as, but not limited to, nylon, rayon, biocompatible polyurethanes, polytetrafluoroethylene (known as PTFE or under the trade name Teflon®), and mixtures thereof.
- materials such as, but not limited to, nylon, rayon, biocompatible polyurethanes, polytetrafluoroethylene (known as PTFE or under the trade name Teflon®), and mixtures thereof.
- the occlusion member 24 may also include or incorporate yet another material such as a coating, or, as part of the woven mesh, a connective tissue material including extracellular matrix (ECM) comprised of small intestinal submucosa (SIS).
- ECM extracellular matrix
- the SIS may be used to temporarily adhere at least part of the occlusion member 24 to the walls of the body vessel 42 in which the device 10 is deployed. Since it may be desirable to only temporarily occlude the body vessel 42 , when the device 10 is deployed in the body vessel, host cells of the wall may adhere to a portion of the device 10 but will not differentiate, allowing for later retrieval of the device 10 from the body vessel 42 . However, in other applications where more permanent occlusion is desired, the device 10 may remain in place and the host cells of the wall may differentiate into the occlusion member 24 , eventually replacing the SIS with the host cells of the body vessel 42 .
- the device 10 When introduced into a body vessel 42 , the device 10 may be oriented such that the proximal hub 12 is directed into a direction of blood flow as indicated by the arrow 54 . Alternatively, the device may be introduced into the vessel in the opposite orientation such that the distal hub is oriented into a direction of blood flow, so in other words, the device may not be directionally dependent and can be introduced in a direction or orientation as necessary or desired depending on the procedure and/or location in the body. As previously mentioned, the device 10 , and in particular at least a portion of occlusion member 24 , is configured to prevent blood, emboli and other fluids from passing, thereby occluding the body vessel 42 .
- the occlusion member 24 extends radially around the longitudinal axis 18 thus forming an interior volume or space 40 .
- the interior space 40 may also include one or more additional structures (not shown) that form an additional barrier to fluid (such as blood).
- This may include, for example, one or more disk-like structures that lie substantially perpendicular to the longitudinal axis 18 , springs, coils and/or a plurality fibers extending radially with respect to the axis 18 . Any one or more of these additional occluding structures may be wholly contained within the volume 40 , and in other examples, may lie outside the volume 40 .
- the occlusion member 24 preferably collapses into a closed or radially inwardly contracted “delivery” configuration extending substantially along the longitudinal axis 18 during delivery of the device 10 .
- the device 10 is preferably disposed within an outer delivery sheath 56 of a delivery assembly 100 which retains the device 10 in its radially contracted state during delivery.
- the outer delivery sheath 56 has a tubular body 58 extending from a proximal part 62 to a distal part 60 .
- An inner member or catheter 64 is disposed within a sheath lumen 66 and is configured for axial movement relative to the outer sheath 56 .
- the inner catheter 64 may be any type of elongate pushing member including, for example, a rod, stylet, or the like.
- the device 10 is removably coupled to a distal portion 68 of the inner catheter 64 and is deployable through the distal end 60 of the outer delivery sheath 56 by means of the relative axial movement of the inner catheter 64 .
- the device 10 is not coupled to the inner catheter 64 but is merely pushed by the inner catheter 64 through the sheath 56 to a desired delivery location within a patient's body.
- the device 10 may be removably coupled to the inner catheter 64 in various ways.
- the distal portion 68 of the inner catheter 64 may be configured to engage at least one of the proximal and/or distal hubs 12 , 30 .
- the distal portion 68 may include a flexible threading coil for engaging the hub. Examples of a threading coil are disclosed in U.S. Pat. No. 5,725,534; U.S. Pat. No. 6,458,137 and/or U.S. Pat. No. 8,308,752; which are herein incorporated by reference.
- the device 10 may also be removeably coupled to the delivery assembly by other attachment mechanisms, including friction fit, fasteners or coupling appendages. As best shown in FIGS.
- the proximal and/or distal ends and/or hubs 12 , 30 may include a coupling mechanism 70 .
- the coupling mechanism 70 is formed on distal hub 30 and may be any complimentary feature appropriate for engaging the inner catheter 64 .
- the coupling mechanism 70 formed on the hub 30 may be a female opening, such as lumen 38 that may be threaded, an aperture, a slot, a recess, indentation, cut-out or the like, or alternatively, it may be a male structure, such as a flange, finger or projection that may, if desired, be threaded.
- the inner catheter 64 preferably includes a complimentary structure configured to engage with the coupling mechanism 70 on the hub 30 . As FIG. 2 and FIG.
- the hub 30 includes a female opening 72 , which is preferably formed as a recess or cut-out, that is shaped to receive a correspondingly shaped male projection 74 formed on the distal end 68 of the delivery catheter 64 .
- the male projection 74 can be generally described as having a “lollipop” shape which is received by a similarly shaped recess 72 formed in the hub 30 for capturing the lollipop 74 .
- other corresponding shapes including but not limited to square, rectangle, diamond or other shapes, forms or engageable structures formed on the hub 30 and on the catheter 64 may also be suitable which allow for the device 10 to be releasably secured to the delivery assembly 100 .
- the distal end 68 of the delivery catheter 64 comprises two “lollipop” shaped projections 74 extending therefrom.
- the two projections 74 may be diametrically opposed structures that are received by two correspondingly shaped recesses 72 formed in hub 30 .
- the delivery catheter 64 and projections 74 may be formed from the same material or alternatively, the projections 74 may be formed of a material different from that of the catheter 64 .
- the projections 74 are formed at least partially from a shape-memory alloy such as Nitinol. Thus, in a natural, relaxed state, the projections 74 flare radially outwardly at the distal-most end 75 .
- the projections 74 become radially outwardly flared such that the diameter formed between distal most ends 75 of projections 74 is greater than the diameter of the distal end 68 of delivery catheter 64 .
- the projections are pushed radially inwardly and urged into and “captured” by the correspondingly shaped recesses 72 formed in the hub. As illustrated in FIG.
- the projections 74 remain captured within recesses 72 , as the diameter between the distal-most ends 75 of the projections 74 is approximately the same as the diameter of the distal end 68 of the delivery catheter 64 when contained by the sheath.
- retraction of the sheath 56 and subsequent outward flaring of projections 74 results in the projections 74 being separated from the recesses 72 as FIGS. 4 and 8 show. This allows the occlusion device 10 to be uncoupled from the delivery catheter 64 and deployed at a desired location within a vessel.
- the device 10 can be repositioned or retracted from the vessel 42 .
- At least part of the occlusion member 24 extends radially outwardly from the longitudinal axis 18 when deployed such that it achieves sufficient radial force against at least a portion of the vessel wall 42 .
- Such radial outward expansion of the device 10 upon deployment may be achieved in several ways.
- one or more resilient inner central elongate member(s) 76 extends between the proximal and distal hubs 12 , 30 as shown in FIGS. 1 and 2 .
- one central elongate member 76 may include a coiled member or spring that extends substantially along the longitudinal axis 18 and may optionally define a third lumen (not shown) between the first and second lumens 22 and 38 of the first and second hubs 12 and 30 .
- a proximal end 78 of the spring 76 is secured to the proximal hub 12 and a distal end 80 of the spring 76 is secured to the distal hub 30 .
- the proximal and distal ends 78 , 80 of the spring 76 may be secured or adjoined to the respective hubs 12 , 30 by various suitable attachment mechanisms, including welding, adhesives, friction fit, threading and/or other attachment members.
- the spring 76 is preferably biased in a contracted condition, such that when in a relaxed state (e.g., upon deployment of device 10 when the delivery sheath 56 is retracted and removed), the ends 78 , 80 of the spring 76 contract towards each other, thus pulling the respective proximal and distal hubs 12 , 30 towards each other.
- the woven mesh of the occlusion member 24 extends radially outwardly at a location 44 that is generally centered between the respective hubs 12 , 30 to form a substantially elliptical, ovoidal or egg-shape as illustrated in FIG. 1 .
- the device 10 is generally self-expanding in that the central elongate member 76 contracts in its natural state when unsheathed, thus, promoting expansion of the occlusion member 24 .
- the contraction of the central elongate member 76 may alone provide a self-expanding device 10 .
- occlusion member 24 may also be constructed of a material having self-expanding properties (e.g. a woven mesh including nitinol, for example) which may radially self-expand in its natural relaxed state (e.g., when the delivery sheath 56 is retracted and removed).
- the self-expanding properties of central elongate member 76 alone and/or in combination with an occlusion member 24 that may also include self-expanding properties facilitates radial self-expansion of the device 10 within a vessel.
- the central elongate member 76 is also preferably longitudinally extensible such that it can be lengthened or stretched to facilitate a radially constricted delivery configuration of the device 10 as shown in FIG. 2 .
- the central elongate member 76 may be made from an appropriate resilient elastic material, including elastic polymer, stainless steel coil, a spring or any other appropriate flexible material that allows for longitudinal extension and contraction.
- the respective hubs 12 and 30 are extended away from each other in substantially opposing directions, thus longitudinally extending the central elongate member 76 .
- the occlusion member 24 becomes radially inwardly contracted into a more slender delivery profile within the sheath 56 . Withdrawal of the sheath 56 allows for the device 10 to radially outwardly self-expand within the vessel as shown in FIG. 1 and described in detail herein.
- radial outward expansion of the occlusion device 10 may be achieved by providing two separate inner central elongate members 82 , 84 coupled to each of the respective hubs 12 , 30 as shown in FIGS. 3 and 4 .
- the two central elongate members 82 , 84 may be in the form of springs or coils, or alternatively, two correspondingly shaped threaded members, one of which is configured to receive the other in a threadedly engaging manner.
- the two elongate members 82 , 84 preferably extend from each of the respective hubs 12 , 30 towards each other to a point where their respective terminating ends are adjacent, and/or abut as shown in FIG. 3 , and are capable of otherwise engaging each other as shown in FIG.
- One of the elongate members such as the distal member 84 illustrated in FIG. 4 , may be rotated relative to the other elongate member 82 . Such rotation may be achieved by rotation of the delivery catheter 64 by the user, which, in turn, causes rotation of the distal elongate member 84 . Rotation of the distal elongate member 84 causes the two elongate members 82 , 84 to engage each other (such as by one elongate member threadedly engaging the other elongate member) as illustrated in FIG. 4 which, in turn, pulls the respective hubs 12 , 30 towards each other along the longitudinal axis.
- the woven mesh of the occlusion member 24 becomes extended radially outwardly at a location generally between the respective hubs 12 , 30 to form a substantially elliptical, ovoidal or egg-shape as illustrated in FIG. 4 .
- rotation of distal elongate member 84 causes the elongate members 82 , 84 to unthread or otherwise disengage, thus moving the respective hubs 12 , 30 longitudinally away from each other, such that the occlusion member 24 may be returned to a radially-inwardly constricted delivery configuration, as illustrated in FIG. 3 and, if necessary or desired, the device 10 may be recaptured or resheathed for adjustment and/or relocation of the device 10 .
- FIGS. 5 and 6 depict a delivery assembly 100 for introducing and retrieving an occlusion device 10 for occluding a body vessel 42 .
- the delivery assembly 100 preferably includes an introducer sheath 102 that may be constructed from various flexible biocompatible materials such as polytetrafluoroethylene (PTFE), for percutaneously introducing an outer delivery sheath 56 into a body vessel 42 .
- PTFE polytetrafluoroethylene
- the introducer sheath 102 may have any suitable size, for example, between about three-french to twelve-french, depending on the particular use and location of delivery and deployment.
- the introducer sheath 102 serves to allow the outer delivery sheath 56 and an inner member or catheter 64 to be percutaneously inserted to a desired location in the body cavity and/or vessel 42 .
- the introducer sheath 102 receives the outer delivery sheath 56 and provides stability to the outer delivery sheath 56 as the outer delivery sheath 56 is advanced through the introducer sheath 102 to an occlusion area in the vasculature.
- the outer delivery sheath 56 has a hub 104 at its proximal end sized and configured to receive the inner catheter 64 and occlusion device 10 to be advanced therethrough.
- the size of the outer delivery sheath 56 may be based on the size of the body vessel 42 in which it percutaneously inserts, and the size of the device 10 .
- the assembly 100 may also include a wire guide 106 configured to be percutaneously inserted within the vasculature to guide the outer delivery sheath 56 to the occlusion area.
- the wire guide 106 provides the outer delivery sheath 56 with a path to follow as it is advanced within the body vessel 42 .
- the size of the wire guide 106 may be based on the inside diameter of the outer delivery sheath 56 and the diameter of the target body vessel 42 . In one non-limiting example, a wire having a size of about 0.018 inches to about 0.038 inches may be used.
- the wire guide 106 is removed and the occlusion device 10 , having a distal segment, end and/or hub 30 contacting, coupled to or otherwise releasably engaged with a distal portion 68 of the inner catheter 64 , is inserted into the outer delivery sheath 56 .
- the inner catheter 64 is advanced through the outer delivery sheath 56 for deployment of the device 10 through the distal end 108 to occlude the body vessel 42 during treatment of, for example, an aneurism.
- the distal portion 68 of the inner catheter 64 includes a coupling mechanism as previously described which, in one non-limiting example, comprises a male coupling or protrusion 74 generally in the shape of a lollipop for releasably engaging or otherwise coupling to a correspondingly female-shaped opening, aperture, cut-out, slot and/or recess 72 formed in distal hub 30 of the device 10 .
- the occlusion device 10 may be removably attached to the distal portion 68 of the inner catheter 64 in other known ways as previously mentioned, or in yet another example, the inner catheter 64 may not be attached to the device 10 , but instead, the inner catheter 64 may simply be used to push the device 10 through delivery sheath 56 to its desired deployment location.
- the device 10 and inner catheter 64 are coaxially advanced through the outer delivery sheath 56 in order to position the device 10 to occlude the body vessel 42 .
- the device 10 is guided through the outer delivery sheath 56 by the inner catheter 64 , preferably from the hub 104 , and exits from the distal end 108 of the outer delivery sheath 56 at a location within the vasculature where occlusion is desired.
- the device 10 may be retrieved and/or repositioned by positioning the distal end 108 of the outer delivery sheath 56 adjacent the deployed device 10 in the vasculature.
- the inner catheter 64 is advanced through the outer delivery sheath 56 until the distal portion 68 protrudes from the distal end 108 of the outer delivery sheath 56 .
- the distal portion 68 is coupled to a distal end or hub 30 of the device 10 , such as by female recess 72 of coupling mechanism 70 capturing male protrusion 74 , after which the inner catheter 64 is retracted proximally, drawing the device 10 into the outer delivery sheath 56 for repositioning and/or removal.
- occlusion device 10 provides easy, efficient, safe and dependable occlusion of a vessel and/or body lumen with improved stasis time and minimal risk of migration of the device 10 .
- occlusion device 10 may be provided in a variety of sizes, shapes, lengths and combinations thereof, thus providing an immediately deliverable design for achieving occlusive properties for multiple uses and varying locations of placement, serving unique patient anatomies and shortening occlusion and stasis times.
- the delivery assembly described above is merely one example of an assembly that may be used to deliver and deploy the occlusion device 10 in a body vessel.
- other apparatus, assemblies and systems may be used to deploy any embodiment of the occlusion device in a vessel, organ or body lumen as necessary or desired.
Abstract
Description
- The present invention generally relates to embolization or occlusion devices for the human and animal body.
- An embolization or occlusion device can be placed within the lumen or interior space of an organ or physiological conduit including arteries, veins, vessels, the bilary tree, the urinary tract, the alimentary tract, the tracheobronchial tree, the genitourinary system, and the cerebral aqueduct. Occlusion devices are used for a number of different purposes, all with the common feature that it is desired to limit or stop the free flow of fluid or blood in an area of the body.
- One example of an endovascular field of application for occlusion devices for percutaneous, transluminal insertion using minimally invasive techniques, is occlusion of an aneurism to prevent rupture of the vessel wall with resulting bleeding. Other applications include occlusion or treatment of varicose veins, occlusion of arteriovenous malformations (AVM), blocking of the blood flow to a tumor, and/or closure of traumatically conditioned blood flows caused by wounds, bodily injuries or gastrointestinal bleeding.
- Occlusion devices can be used in many different places in the vascular system and in vessels of differing sizes and geometries. Therefore, many different occlusion devices have been designed with various basic predetermined shapes and of varying sizes. Conventionally, the predetermined shape of the occlusion device is made so that the body of the device has a diameter of the same size or slightly larger than the relevant vessel lumen, so that the body of the device exerts an abutment pressure against the vessel wall. When it is desirable to quickly occlude a blood vessel, an inflatable balloon may be temporarily used. Another example of a more permanent occlusion device includes embolization coils, which may promote blood clots or tissue growth over a period of time, thereby occluding the body cavity and/or vessel lumen. Occlusion devices having other shapes and structures may also be used as necessary or desired, including but not limited to barrels, disks, wires and/or fibers.
- To deliver an occlusion device, a delivery assembly including a guidewire and a catheter may be placed transluminally in the vascular system having its distal catheter end at the site of placement. When the occlusion device leaves the distal end of the catheter, it seeks to assume a predetermined shape within the vessel or alternatively, it can be mechanically expanded within the vessel. If the size and shape of the device are deemed suitable for the vessel geometry at the site of placement, the occlusion device is disconnected from the components of the delivery assembly and the assembly removed from the vasculature.
- Disclosed herein is an improved occlusion device for occluding a body lumen and/or vessel. Also disclosed is a delivery assembly and methods for placing and retrieving an occlusion device within a body vessel.
- In one example, an occlusion device for occluding a body lumen is disclosed. The occlusion device comprises a proximal end, a distal end spaced from the proximal end along a longitudinal axis, and an occluding member disposed between the proximal end and distal end. The occluding member has a radially-outwardly expanded configuration and a contracted configuration. At least one biasing member is disposed within the occluding member and extends between the proximal and distal ends along a longitudinal axis, the biasing member having a contracted configuration and an extended configuration. When the occlusion member is in the expanded configuration the biasing member is in the contracted position and when the occlusion member is in the contracted configuration the biasing member is in the extended position.
- Another example of an occlusion device for occluding a body vessel is also disclosed. The occlusion device comprises a proximal end, a distal end spaced from the proximal end along a longitudinal axis and an occluding member disposed between the proximal end and distal end. The occluding member has a radially-outwardly expanded configuration and a contracted configuration. A first biasing member is disposed within the occluding member having a first end adjoined to the proximal end of the device, and a second biasing member is disposed within the occluding member having a first end adjoined to the distal end of the device. The second biasing member is configured to releasably engage the first biasing member.
-
FIG. 1 is a partial section of a body vessel including one example of an occlusion device in a radially expanded deployed configuration therein. -
FIG. 2 is a partial section of the occlusion device ofFIG. 1 in a collapsed delivery configuration within an outer sheath and a distal portion of one example of a delivery assembly. -
FIG. 3 is a partial section of another example of an occlusion device in a collapsed delivery configuration within an outer sheath and a distal portion of one example of a delivery assembly. -
FIG. 4 is a partial section of a body vessel including another example of an occlusion device in a radially expanded deployed configuration therein. -
FIG. 5 is a side view of one example of a delivery and retrieval assembly for use with an occlusion device. -
FIG. 6 is an exploded view of the delivery and retrieval assembly ofFIG. 5 . -
FIG. 7 illustrates one example of the distal end of the a delivery device engaged with the occlusion device within a delivery sheath. -
FIG. 8 illustrates one example of a delivery sheath partially withdrawn and the distal end of a delivery device disengaged from the occlusion device. - Throughout this specification the terms “proximal” and “proximally” are used to refer to a position or direction towards the patient's heart and the terms “distal” and “distally” are used for a position or direction away the patient's heart when describing an occlusion device. In the arterial system, downstream refers to the direction further from the heart, while upstream refers to the direction closer to the heart. The terms proximal and distal, when used herein in relation to instruments used in the procedure, such as a delivery assembly, delivery device, catheter, guide wire and the like, refer to directions closer to and farther away from the operator performing the procedure. Thus, a distal end of a delivery catheter or guide wire would be farther away from the operator, while the proximal end of a delivery catheter or guide wire would be closer to the operator.
- Referring now to
FIG. 1 , a first embodiment of an occlusion device is designated at 10. Theocclusion device 10 includes a first orproximal hub 12 extending from aproximal end 14 to adistal end 16 and along alongitudinal axis 18 with atubular wall 20 optionally defining alumen 22. Aproximal end 26 of anoccluding member 24 is attached to theproximal hub 12 and extends distally therefrom for attachment at itsdistal end 28 to a second ordistal hub 30.Distal hub 30 has aproximal end 32 and adistal end 34, with atubular wall 36 optionally defining asecond lumen 38. Theoccluding member 24 may define an interior volume orspace 40. Preferably, at least a portion ofmember 24 forms an occlusive barrier when deployed within a body lumen and/orvessel 42. - By way of example,
occlusion member 24 may extend between thedistal end 16 of the first (proximal)hub 12 and aproximal end 32 of the second (distal)hub 30. Amiddle portion 44 of theoccluding member 24 extends radially away from thelongitudinal axis 18 when thedevice 10 is in an open configuration to form awider diameter portion 46. In one example, thewider diameter portion 46 of theocclusion member 24 is generally centered or formed within amiddle section 44 ofoccluding member 24, but alternatively, thewider diameter portion 46 may be off-center, such that it is located closer to one hub or the other as needed, depending, for example, on the particular use of thedevice 10 or the patient's unique anatomy. Preferably, thewider diameter portion 46 extends radially outwardly for a wide enough distance so that at least a portion of theocclusion member 24 is substantially adjacent to and/or abuts the vessel wall when thedevice 10 is deployed within thebody vessel 42 as shown inFIG. 1 andFIG. 4 . Preferably, at least part of theocclusion member 24, such aswider diameter portion 46, extends outwardly from thelongitudinal axis 18 and achieves sufficient radial force against at least a portion of the vessel wall to hold and/or secure thedevice 10 in place so that risk of dislodgment and/or migration of thedevice 10 is substantially reduced or otherwise eliminated. The radially outward expansion of the device upon delivery and deployment is described in further detail below. - As further illustrated in
FIGS. 1 and 4 , theocclusion member 24 may taper radially inwardly from thewider diameter portion 46 to a morenarrow diameter portions distal ends narrow diameter portions respective hubs member 24 may be integrally formed with one or both of thehubs FIG. 1 , the proximal and/ordistal ends occlusion member 24 may be crimped down or otherwise contracted radially inwardly so that they can be held by, inserted into or otherwise retained within the respective proximal anddistal hubs - Optionally, the
occlusion member 24 and/or one or both ofhubs device 10 from moving or migrating within thebody vessel 42. The anchoring members may include a plurality of barbs. Other examples of the anchoring members may include hooks, roughened surfaces or other similar structures that may engage the vessel wall and serve to prevent migration or dislodgement of thedevice 10 after deployment in thevessel 42. - One or both of the proximal and/or
distal hubs hubs FIGS. 1-4 , one or both of thehubs proximal hub 12 may include a rounded or smoothatraumatic tip 52 placed thereon. In one example, theatraumatic tip 52 is formed in a bullet-nose shape, but may also include other domed, smooth or rounded shapes. Theatraumatic tip 52 may either be removably secured to theproximal hub 12 to aid in the placement and delivery of thedevice 10 in a desired location within a vessel or body lumen, after which time thetip 52 may be removed from thedevice 10 during and/or after deployment. Alternatively, theatraumatic tip 52 may be permanently secured to theproximal hub 12 such that it remains secured to thedevice 10 when it is deployed within avessel 42, or, in yet another alternative, theproximal hub 12 itself may be atraumatically shaped, smooth and/or rounded. An atraumatically shapedhub 12 and/oratraumatic tip 52 may facilitate the ease of delivery and placement of thedevice 10 in tortuous anatomy while also reducing or eliminating vessel damage or injury. - The occluding
member 24 may be a variety of structures including, but not limited to, one or more wires, coils, fabrics, fibers, flexible arcuate members, cages, screens, disks, walls and the like and may be constructed or formed from a single material or, alternatively, may be formed from a variety or combination of materials. In one example, at least a portion ofocclusion member 24 may be formed of any suitable material that may be expanded, such as by mechanical expansion. In other examples, at least a portion of the occlusion member may be formed from any suitable material that will result in a self-opening or self-expandingdevice 10, such as shape memory material. Shape memory material that is heated (or cooled) above (or below) a transition temperature causes the material to undergo a phase transformation such that the material returns to its “remembered” state. Thus, when thedevice 10 is deployed in abody vessel 42 having a particular temperature thedevice 10 will transform to the remembered (expanded) state within thevessel 42. To remove thedevice 10, it may be cooled (or, alternatively heated) to transform the material to a more malleable state, such that thedevice 10 can be more easily collapsed and pulled into a lumen of a catheter (re-sheathed) for removal. One shape memory alloy suitable for the present invention is Ni—Ti, also known as nitinol. - As shown in
FIG. 1 andFIG. 4 ,occlusion member 24 is preferably formed of a woven mesh constructed of nitinol wire and a polyester fiber (polyethylene terephthalate commonly abbreviated PET, PETE) or referred to by the trade name Dacron®. The nitinol and polyester fiber mesh may be woven in any suitable combination or ratio, and in one example, the materials may be woven together in a ratio of 1:1 to form a mesh. The polyester fibers may act as a thrombogenic agent upon delivery and nesting of the device in avessel 42 or body lumen. In an alternative embodiment, theocclusion member 24 may also be at least partially constructed of materials such as, but not limited to, nylon, rayon, biocompatible polyurethanes, polytetrafluoroethylene (known as PTFE or under the trade name Teflon®), and mixtures thereof. - In addition to a woven mesh of nitinol and a polyester fiber, the
occlusion member 24 may also include or incorporate yet another material such as a coating, or, as part of the woven mesh, a connective tissue material including extracellular matrix (ECM) comprised of small intestinal submucosa (SIS). In one particular embodiment, the SIS may be used to temporarily adhere at least part of theocclusion member 24 to the walls of thebody vessel 42 in which thedevice 10 is deployed. Since it may be desirable to only temporarily occlude thebody vessel 42, when thedevice 10 is deployed in the body vessel, host cells of the wall may adhere to a portion of thedevice 10 but will not differentiate, allowing for later retrieval of thedevice 10 from thebody vessel 42. However, in other applications where more permanent occlusion is desired, thedevice 10 may remain in place and the host cells of the wall may differentiate into theocclusion member 24, eventually replacing the SIS with the host cells of thebody vessel 42. - When introduced into a
body vessel 42, thedevice 10 may be oriented such that theproximal hub 12 is directed into a direction of blood flow as indicated by thearrow 54. Alternatively, the device may be introduced into the vessel in the opposite orientation such that the distal hub is oriented into a direction of blood flow, so in other words, the device may not be directionally dependent and can be introduced in a direction or orientation as necessary or desired depending on the procedure and/or location in the body. As previously mentioned, thedevice 10, and in particular at least a portion ofocclusion member 24, is configured to prevent blood, emboli and other fluids from passing, thereby occluding thebody vessel 42. As previously mentioned, theocclusion member 24 extends radially around thelongitudinal axis 18 thus forming an interior volume orspace 40. In one example, theinterior space 40 may also include one or more additional structures (not shown) that form an additional barrier to fluid (such as blood). This may include, for example, one or more disk-like structures that lie substantially perpendicular to thelongitudinal axis 18, springs, coils and/or a plurality fibers extending radially with respect to theaxis 18. Any one or more of these additional occluding structures may be wholly contained within thevolume 40, and in other examples, may lie outside thevolume 40. - As best shown in
FIGS. 2 and 3 , theocclusion member 24 preferably collapses into a closed or radially inwardly contracted “delivery” configuration extending substantially along thelongitudinal axis 18 during delivery of thedevice 10. For example, during delivery, thedevice 10 is preferably disposed within anouter delivery sheath 56 of adelivery assembly 100 which retains thedevice 10 in its radially contracted state during delivery. Theouter delivery sheath 56 has atubular body 58 extending from aproximal part 62 to adistal part 60. An inner member orcatheter 64 is disposed within asheath lumen 66 and is configured for axial movement relative to theouter sheath 56. Theinner catheter 64 may be any type of elongate pushing member including, for example, a rod, stylet, or the like. Thedevice 10 is removably coupled to adistal portion 68 of theinner catheter 64 and is deployable through thedistal end 60 of theouter delivery sheath 56 by means of the relative axial movement of theinner catheter 64. In another example, thedevice 10 is not coupled to theinner catheter 64 but is merely pushed by theinner catheter 64 through thesheath 56 to a desired delivery location within a patient's body. - The
device 10 may be removably coupled to theinner catheter 64 in various ways. For example, thedistal portion 68 of theinner catheter 64 may be configured to engage at least one of the proximal and/ordistal hubs distal portion 68 may include a flexible threading coil for engaging the hub. Examples of a threading coil are disclosed in U.S. Pat. No. 5,725,534; U.S. Pat. No. 6,458,137 and/or U.S. Pat. No. 8,308,752; which are herein incorporated by reference. Thedevice 10 may also be removeably coupled to the delivery assembly by other attachment mechanisms, including friction fit, fasteners or coupling appendages. As best shown inFIGS. 2 and 3 , the proximal and/or distal ends and/orhubs coupling mechanism 70. As illustrated, thecoupling mechanism 70 is formed ondistal hub 30 and may be any complimentary feature appropriate for engaging theinner catheter 64. Thecoupling mechanism 70 formed on thehub 30 may be a female opening, such aslumen 38 that may be threaded, an aperture, a slot, a recess, indentation, cut-out or the like, or alternatively, it may be a male structure, such as a flange, finger or projection that may, if desired, be threaded. Theinner catheter 64 preferably includes a complimentary structure configured to engage with thecoupling mechanism 70 on thehub 30. AsFIG. 2 andFIG. 3 illustrates, thehub 30 includes afemale opening 72, which is preferably formed as a recess or cut-out, that is shaped to receive a correspondingly shapedmale projection 74 formed on thedistal end 68 of thedelivery catheter 64. As shown there, themale projection 74 can be generally described as having a “lollipop” shape which is received by a similarly shapedrecess 72 formed in thehub 30 for capturing thelollipop 74. Of course, other corresponding shapes, including but not limited to square, rectangle, diamond or other shapes, forms or engageable structures formed on thehub 30 and on thecatheter 64 may also be suitable which allow for thedevice 10 to be releasably secured to thedelivery assembly 100. - As shown in more detail in
FIGS. 7 and 8 , thedistal end 68 of thedelivery catheter 64 comprises two “lollipop” shapedprojections 74 extending therefrom. The twoprojections 74 may be diametrically opposed structures that are received by two correspondingly shapedrecesses 72 formed inhub 30. Thedelivery catheter 64 andprojections 74 may be formed from the same material or alternatively, theprojections 74 may be formed of a material different from that of thecatheter 64. In one example, theprojections 74 are formed at least partially from a shape-memory alloy such as Nitinol. Thus, in a natural, relaxed state, theprojections 74 flare radially outwardly at thedistal-most end 75. Thus, whensheath 56 is retracted to expose thedistal end 68 of thedelivery catheter 64 as illustrated inFIG. 8 , theprojections 74 become radially outwardly flared such that the diameter formed between distal most ends 75 ofprojections 74 is greater than the diameter of thedistal end 68 ofdelivery catheter 64. However, when thedistal end 68 of thedelivery catheter 64 is sheathed such that thesheath 56 covers theprojections 74 as shown inFIGS. 3 and 7 , the projections are pushed radially inwardly and urged into and “captured” by the correspondingly shapedrecesses 72 formed in the hub. As illustrated inFIG. 7 , theprojections 74 remain captured withinrecesses 72, as the diameter between the distal-most ends 75 of theprojections 74 is approximately the same as the diameter of thedistal end 68 of thedelivery catheter 64 when contained by the sheath. In use, retraction of thesheath 56 and subsequent outward flaring ofprojections 74 results in theprojections 74 being separated from therecesses 72 asFIGS. 4 and 8 show. This allows theocclusion device 10 to be uncoupled from thedelivery catheter 64 and deployed at a desired location within a vessel. If recapture, repositioning and/or removal of thedevice 10 is desired, re-sheathing of thedistal end 68 of thedelivery catheter 64 and of the device 10 (by pushing the sheath distally) urges theprojections 74 radially inwardly and back into therecesses 72. With theprojections 74 again captured by therecesses 72 and held in position within thesheath 56, thedevice 10 can be repositioned or retracted from thevessel 42. - As mentioned above, at least part of the
occlusion member 24, such aswider diameter portion 46, extends radially outwardly from thelongitudinal axis 18 when deployed such that it achieves sufficient radial force against at least a portion of thevessel wall 42. Such radial outward expansion of thedevice 10 upon deployment may be achieved in several ways. First, in one example, one or more resilient inner central elongate member(s) 76 extends between the proximal anddistal hubs FIGS. 1 and 2 . In the example shown, onecentral elongate member 76 may include a coiled member or spring that extends substantially along thelongitudinal axis 18 and may optionally define a third lumen (not shown) between the first andsecond lumens second hubs proximal end 78 of thespring 76 is secured to theproximal hub 12 and adistal end 80 of thespring 76 is secured to thedistal hub 30. The proximal and distal ends 78, 80 of thespring 76 may be secured or adjoined to therespective hubs spring 76 is preferably biased in a contracted condition, such that when in a relaxed state (e.g., upon deployment ofdevice 10 when thedelivery sheath 56 is retracted and removed), the ends 78, 80 of thespring 76 contract towards each other, thus pulling the respective proximal anddistal hubs occlusion member 24 extends radially outwardly at alocation 44 that is generally centered between therespective hubs FIG. 1 . In other words, thedevice 10 is generally self-expanding in that the centralelongate member 76 contracts in its natural state when unsheathed, thus, promoting expansion of theocclusion member 24. The contraction of the centralelongate member 76 may alone provide a self-expandingdevice 10. However, as previously mentioned,occlusion member 24 may also be constructed of a material having self-expanding properties (e.g. a woven mesh including nitinol, for example) which may radially self-expand in its natural relaxed state (e.g., when thedelivery sheath 56 is retracted and removed). Thus, the self-expanding properties of centralelongate member 76 alone and/or in combination with anocclusion member 24 that may also include self-expanding properties, facilitates radial self-expansion of thedevice 10 within a vessel. - The central
elongate member 76 is also preferably longitudinally extensible such that it can be lengthened or stretched to facilitate a radially constricted delivery configuration of thedevice 10 as shown inFIG. 2 . As such, the centralelongate member 76 may be made from an appropriate resilient elastic material, including elastic polymer, stainless steel coil, a spring or any other appropriate flexible material that allows for longitudinal extension and contraction. When thedevice 10 is sheathed, therespective hubs elongate member 76. As a result, theocclusion member 24 becomes radially inwardly contracted into a more slender delivery profile within thesheath 56. Withdrawal of thesheath 56 allows for thedevice 10 to radially outwardly self-expand within the vessel as shown inFIG. 1 and described in detail herein. - In alternative example, radial outward expansion of the
occlusion device 10 may be achieved by providing two separate inner centralelongate members respective hubs FIGS. 3 and 4 . The two centralelongate members elongate members respective hubs FIG. 3 , and are capable of otherwise engaging each other as shown inFIG. 4 . One of the elongate members, such as thedistal member 84 illustrated inFIG. 4 , may be rotated relative to the otherelongate member 82. Such rotation may be achieved by rotation of thedelivery catheter 64 by the user, which, in turn, causes rotation of the distalelongate member 84. Rotation of the distalelongate member 84 causes the twoelongate members FIG. 4 which, in turn, pulls therespective hubs hubs occlusion member 24 becomes extended radially outwardly at a location generally between therespective hubs FIG. 4 . Similarly, rotation of distal elongate member 84 (such as by rotation of thecatheter 64 in the opposite direction) causes theelongate members respective hubs occlusion member 24 may be returned to a radially-inwardly constricted delivery configuration, as illustrated inFIG. 3 and, if necessary or desired, thedevice 10 may be recaptured or resheathed for adjustment and/or relocation of thedevice 10. -
FIGS. 5 and 6 depict adelivery assembly 100 for introducing and retrieving anocclusion device 10 for occluding abody vessel 42. As shown, thedelivery assembly 100 preferably includes anintroducer sheath 102 that may be constructed from various flexible biocompatible materials such as polytetrafluoroethylene (PTFE), for percutaneously introducing anouter delivery sheath 56 into abody vessel 42. Of course, any other suitable material for theintroducer sheath 102, orouter delivery sheath 56 may be used. Theintroducer sheath 102 may have any suitable size, for example, between about three-french to twelve-french, depending on the particular use and location of delivery and deployment. Theintroducer sheath 102 serves to allow theouter delivery sheath 56 and an inner member orcatheter 64 to be percutaneously inserted to a desired location in the body cavity and/orvessel 42. Theintroducer sheath 102 receives theouter delivery sheath 56 and provides stability to theouter delivery sheath 56 as theouter delivery sheath 56 is advanced through theintroducer sheath 102 to an occlusion area in the vasculature. As shown inFIGS. 5 and 6 theouter delivery sheath 56 has ahub 104 at its proximal end sized and configured to receive theinner catheter 64 andocclusion device 10 to be advanced therethrough. The size of theouter delivery sheath 56 may be based on the size of thebody vessel 42 in which it percutaneously inserts, and the size of thedevice 10. - As shown, the
assembly 100 may also include awire guide 106 configured to be percutaneously inserted within the vasculature to guide theouter delivery sheath 56 to the occlusion area. Thewire guide 106 provides theouter delivery sheath 56 with a path to follow as it is advanced within thebody vessel 42. The size of thewire guide 106 may be based on the inside diameter of theouter delivery sheath 56 and the diameter of thetarget body vessel 42. In one non-limiting example, a wire having a size of about 0.018 inches to about 0.038 inches may be used. - When a
distal end 108 of theouter delivery sheath 56 is at the desired location in thebody vessel 42, thewire guide 106 is removed and theocclusion device 10, having a distal segment, end and/orhub 30 contacting, coupled to or otherwise releasably engaged with adistal portion 68 of theinner catheter 64, is inserted into theouter delivery sheath 56. Theinner catheter 64 is advanced through theouter delivery sheath 56 for deployment of thedevice 10 through thedistal end 108 to occlude thebody vessel 42 during treatment of, for example, an aneurism. Preferably, thedistal portion 68 of theinner catheter 64 includes a coupling mechanism as previously described which, in one non-limiting example, comprises a male coupling orprotrusion 74 generally in the shape of a lollipop for releasably engaging or otherwise coupling to a correspondingly female-shaped opening, aperture, cut-out, slot and/orrecess 72 formed indistal hub 30 of thedevice 10. Alternatively, theocclusion device 10 may be removably attached to thedistal portion 68 of theinner catheter 64 in other known ways as previously mentioned, or in yet another example, theinner catheter 64 may not be attached to thedevice 10, but instead, theinner catheter 64 may simply be used to push thedevice 10 throughdelivery sheath 56 to its desired deployment location. - Following removal of the
wire guide 106, thedevice 10 andinner catheter 64 are coaxially advanced through theouter delivery sheath 56 in order to position thedevice 10 to occlude thebody vessel 42. Thedevice 10 is guided through theouter delivery sheath 56 by theinner catheter 64, preferably from thehub 104, and exits from thedistal end 108 of theouter delivery sheath 56 at a location within the vasculature where occlusion is desired. Likewise, thedevice 10 may be retrieved and/or repositioned by positioning thedistal end 108 of theouter delivery sheath 56 adjacent the deployeddevice 10 in the vasculature. Theinner catheter 64 is advanced through theouter delivery sheath 56 until thedistal portion 68 protrudes from thedistal end 108 of theouter delivery sheath 56. Thedistal portion 68 is coupled to a distal end orhub 30 of thedevice 10, such as byfemale recess 72 ofcoupling mechanism 70 capturingmale protrusion 74, after which theinner catheter 64 is retracted proximally, drawing thedevice 10 into theouter delivery sheath 56 for repositioning and/or removal. - The
occlusion device 10 and methods of use described herein provides easy, efficient, safe and dependable occlusion of a vessel and/or body lumen with improved stasis time and minimal risk of migration of thedevice 10. Advantageously,occlusion device 10 may be provided in a variety of sizes, shapes, lengths and combinations thereof, thus providing an immediately deliverable design for achieving occlusive properties for multiple uses and varying locations of placement, serving unique patient anatomies and shortening occlusion and stasis times. It is understood that the delivery assembly described above is merely one example of an assembly that may be used to deliver and deploy theocclusion device 10 in a body vessel. Of course, other apparatus, assemblies and systems may be used to deploy any embodiment of the occlusion device in a vessel, organ or body lumen as necessary or desired. - Throughout this specification, unless the context requires otherwise, the words “comprise” and “include” and variations such as “comprising” and “including” will be understood to imply the inclusion of an item or group of items, but not the exclusion of any other item or group items.
- While various embodiments of the invention have been described, it will be apparent to those of ordinary skill in the art that many more embodiments and implementations are possible within the scope of the invention. Furthermore, although various indications have been given as to the scope of this invention, the invention is not limited to any one of these but may reside in two or more of these combined together. Accordingly, the invention is not to be restricted except in light of the attached claims and their equivalents.
Claims (20)
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/293,536 US20150343181A1 (en) | 2014-06-02 | 2014-06-02 | Occlusion device and methods of using the same |
US15/728,710 US10299797B2 (en) | 2014-06-02 | 2017-10-10 | Occlusion device and methods of using the same |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/293,536 US20150343181A1 (en) | 2014-06-02 | 2014-06-02 | Occlusion device and methods of using the same |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/728,710 Division US10299797B2 (en) | 2014-06-02 | 2017-10-10 | Occlusion device and methods of using the same |
Publications (1)
Publication Number | Publication Date |
---|---|
US20150343181A1 true US20150343181A1 (en) | 2015-12-03 |
Family
ID=54700576
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/293,536 Abandoned US20150343181A1 (en) | 2014-06-02 | 2014-06-02 | Occlusion device and methods of using the same |
US15/728,710 Active US10299797B2 (en) | 2014-06-02 | 2017-10-10 | Occlusion device and methods of using the same |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US15/728,710 Active US10299797B2 (en) | 2014-06-02 | 2017-10-10 | Occlusion device and methods of using the same |
Country Status (1)
Country | Link |
---|---|
US (2) | US20150343181A1 (en) |
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20160324668A1 (en) * | 2015-05-08 | 2016-11-10 | Stryker European Holdings I, Llc | Vaso-occlusive devices |
WO2017172922A1 (en) | 2016-03-31 | 2017-10-05 | Surmodics, Inc. | Localized treatment of tissues through transcatheter delivery of active agents |
WO2019178579A1 (en) * | 2018-03-16 | 2019-09-19 | Boston Scientific Scimed, Inc. | Devices for vein closure |
US10426646B2 (en) | 2015-03-05 | 2019-10-01 | Cook Medical Technologies Llc | Pre-loaded delivery device with tri-fold proximal prosthesis attachment |
US10478591B2 (en) | 2015-03-05 | 2019-11-19 | Cook Medical Technologies Llc | Stent graft delivery device pre-loaded with a single wire for device tracking and cannulation |
US10729445B2 (en) | 2012-02-09 | 2020-08-04 | Stryker European Holdings I, Llc | Vaso-occlusive devices including a friction element |
US10874402B2 (en) | 2017-10-10 | 2020-12-29 | Boston Scientific Scimed, Inc. | Detachable RF energized occlusive device |
US11000287B2 (en) | 2017-08-15 | 2021-05-11 | Boston Scientific Scimed, Inc. | Occlusive medical device system |
US11154412B2 (en) | 2018-02-01 | 2021-10-26 | Boston Scientific Scimed, Inc. | Medical device release system |
US11191927B2 (en) | 2017-07-31 | 2021-12-07 | Boston Scientific Scimed, Inc. | Dilator with engagement region |
US11229439B2 (en) * | 2015-11-26 | 2022-01-25 | Femtos Gmbh | Band-shaped occlusion means |
US11284902B2 (en) | 2018-02-01 | 2022-03-29 | Boston Scientific Scimed, Inc. | Method of making a vascular occlusion device |
US11305387B2 (en) | 2019-11-04 | 2022-04-19 | Covidien Lp | Systems and methods for treating aneurysms |
US11633190B2 (en) | 2014-05-28 | 2023-04-25 | Stryker European Holdings I, Llc | Vaso-occlusive devices and methods of use |
US11672946B2 (en) | 2019-09-24 | 2023-06-13 | Boston Scientific Scimed, Inc. | Protection and actuation mechanism for controlled release of implantable embolic devices |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US11786388B2 (en) | 2021-03-12 | 2023-10-17 | Cook Medical Technologies Llc | Endovascular delivery systems with radial orientation mechanisms |
Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3834394A (en) * | 1969-11-21 | 1974-09-10 | R Sessions | Occlusion device and method and apparatus for inserting the same |
US5382259A (en) * | 1992-10-26 | 1995-01-17 | Target Therapeutics, Inc. | Vasoocclusion coil with attached tubular woven or braided fibrous covering |
US20050149109A1 (en) * | 2003-12-23 | 2005-07-07 | Wallace Michael P. | Expanding filler coil |
US20060085028A1 (en) * | 2004-10-18 | 2006-04-20 | Robert Boock | Vessel occlusion system |
US20110213403A1 (en) * | 2010-02-23 | 2011-09-01 | Maria Aboytes | Devices and methods for vascular recanalization |
US8088103B2 (en) * | 2008-11-03 | 2012-01-03 | Advanced Catheter Therapies, Inc. | Occlusion perfusion catheter |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DK175166B1 (en) | 1995-01-03 | 2004-06-21 | Cook William Europ | Method of manufacturing an assembly for placing an embolization coil in the vascular system and such assembly as well as an apparatus for advancing the assembly |
US6458137B1 (en) | 1999-05-26 | 2002-10-01 | Cook Incorporated | Assembly for positioning an embolization coil in the vascular system and a method of introducing a detachable embolization coil |
US8308752B2 (en) | 2007-08-27 | 2012-11-13 | Cook Medical Technologies Llc | Barrel occlusion device |
US9504474B2 (en) * | 2011-05-23 | 2016-11-29 | Stryker Corporation | Vaso-occlusive devices with in-situ stiffening |
-
2014
- 2014-06-02 US US14/293,536 patent/US20150343181A1/en not_active Abandoned
-
2017
- 2017-10-10 US US15/728,710 patent/US10299797B2/en active Active
Patent Citations (6)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3834394A (en) * | 1969-11-21 | 1974-09-10 | R Sessions | Occlusion device and method and apparatus for inserting the same |
US5382259A (en) * | 1992-10-26 | 1995-01-17 | Target Therapeutics, Inc. | Vasoocclusion coil with attached tubular woven or braided fibrous covering |
US20050149109A1 (en) * | 2003-12-23 | 2005-07-07 | Wallace Michael P. | Expanding filler coil |
US20060085028A1 (en) * | 2004-10-18 | 2006-04-20 | Robert Boock | Vessel occlusion system |
US8088103B2 (en) * | 2008-11-03 | 2012-01-03 | Advanced Catheter Therapies, Inc. | Occlusion perfusion catheter |
US20110213403A1 (en) * | 2010-02-23 | 2011-09-01 | Maria Aboytes | Devices and methods for vascular recanalization |
Cited By (27)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US10729445B2 (en) | 2012-02-09 | 2020-08-04 | Stryker European Holdings I, Llc | Vaso-occlusive devices including a friction element |
US11633190B2 (en) | 2014-05-28 | 2023-04-25 | Stryker European Holdings I, Llc | Vaso-occlusive devices and methods of use |
US10426646B2 (en) | 2015-03-05 | 2019-10-01 | Cook Medical Technologies Llc | Pre-loaded delivery device with tri-fold proximal prosthesis attachment |
US10478591B2 (en) | 2015-03-05 | 2019-11-19 | Cook Medical Technologies Llc | Stent graft delivery device pre-loaded with a single wire for device tracking and cannulation |
US20160324668A1 (en) * | 2015-05-08 | 2016-11-10 | Stryker European Holdings I, Llc | Vaso-occlusive devices |
US10159490B2 (en) * | 2015-05-08 | 2018-12-25 | Stryker European Holdings I, Llc | Vaso-occlusive devices |
US11751880B2 (en) | 2015-05-08 | 2023-09-12 | Stryker European Holdings I, Llc | Vaso-occlusive devices |
US10925612B2 (en) | 2015-05-08 | 2021-02-23 | Stryker European Holdings I, Llc | Vaso-occlusive devices |
US11229439B2 (en) * | 2015-11-26 | 2022-01-25 | Femtos Gmbh | Band-shaped occlusion means |
WO2017172922A1 (en) | 2016-03-31 | 2017-10-05 | Surmodics, Inc. | Localized treatment of tissues through transcatheter delivery of active agents |
US11191927B2 (en) | 2017-07-31 | 2021-12-07 | Boston Scientific Scimed, Inc. | Dilator with engagement region |
US11000287B2 (en) | 2017-08-15 | 2021-05-11 | Boston Scientific Scimed, Inc. | Occlusive medical device system |
US10874402B2 (en) | 2017-10-10 | 2020-12-29 | Boston Scientific Scimed, Inc. | Detachable RF energized occlusive device |
US11154412B2 (en) | 2018-02-01 | 2021-10-26 | Boston Scientific Scimed, Inc. | Medical device release system |
US11284902B2 (en) | 2018-02-01 | 2022-03-29 | Boston Scientific Scimed, Inc. | Method of making a vascular occlusion device |
US11109867B2 (en) | 2018-03-16 | 2021-09-07 | Boston Scientific Scimed, Inc. | Devices and methods for vein closure |
WO2019178579A1 (en) * | 2018-03-16 | 2019-09-19 | Boston Scientific Scimed, Inc. | Devices for vein closure |
US11672946B2 (en) | 2019-09-24 | 2023-06-13 | Boston Scientific Scimed, Inc. | Protection and actuation mechanism for controlled release of implantable embolic devices |
US11633818B2 (en) | 2019-11-04 | 2023-04-25 | Covidien Lp | Devices, systems, and methods for treatment of intracranial aneurysms |
US11541490B2 (en) * | 2019-11-04 | 2023-01-03 | Covidien Lp | Aneurysm treatment device |
US11504816B2 (en) | 2019-11-04 | 2022-11-22 | Covidien Lp | Systems and methods for treating aneurysms |
US11498165B2 (en) * | 2019-11-04 | 2022-11-15 | Covidien Lp | Systems and methods for treating aneurysms |
US11679458B2 (en) | 2019-11-04 | 2023-06-20 | Covidien Lp | Devices, systems, and methods for treating aneurysms |
US11685007B2 (en) | 2019-11-04 | 2023-06-27 | Covidien Lp | Devices, systems, and methods for treatment of intracranial aneurysms |
US11717924B2 (en) | 2019-11-04 | 2023-08-08 | Covidien Lp | Devices, systems, and methods for treatment of intracranial aneurysms |
US11305387B2 (en) | 2019-11-04 | 2022-04-19 | Covidien Lp | Systems and methods for treating aneurysms |
US11826863B2 (en) | 2019-11-04 | 2023-11-28 | Covidien Lp | Systems and methods for treating aneurysms |
Also Published As
Publication number | Publication date |
---|---|
US10299797B2 (en) | 2019-05-28 |
US20180028191A1 (en) | 2018-02-01 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US10299797B2 (en) | Occlusion device and methods of using the same | |
US11931277B2 (en) | Releasable delivery system | |
JP6113448B2 (en) | Displacement mechanism for tube device | |
US9107733B2 (en) | Removable blood conduit filter | |
US9011481B2 (en) | Vascular occlusion device having a jelly fish | |
JP5559063B2 (en) | Stent design for use with one or more trigger wires | |
US10722392B2 (en) | Methods for delivering and using a stent | |
US9675438B2 (en) | Dome-shaped vascular filter | |
US20120316638A1 (en) | Method and device for treating cerebrovascular pathologies and delivery system therefor | |
JP2022031893A (en) | Embolic device | |
CN115209833A (en) | Clot removal distal protection method | |
EP2942034B1 (en) | Implantation system for inserting a vein filter | |
US10004512B2 (en) | Occlusion device and method of use thereof | |
US20140277086A1 (en) | Umbrella inferior vena cava filter retrieval device |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: COOK MEDICAL TECHNOLOGIES LLC, INDIANA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE, INC.;REEL/FRAME:033096/0277 Effective date: 20140602 Owner name: MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE, INC Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BRADWAY, RYAN;HADLEY, RICK;KRATZBERG, JARIN;AND OTHERS;SIGNING DATES FROM 20140522 TO 20140602;REEL/FRAME:033095/0821 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |