Patent Application
20070299423
The invention may be more completely understood in consideration of the following detailed description of various embodiments of the invention in connection with the accompanying drawings, in which:
While the invention is amenable to various modifications and alternative forms, specifics thereof have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention.
For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification.
All numeric values are herein assumed to be modified by the term “about”, whether or not explicitly indicated. The term “about” generally refers to a range of numbers that one of skill in the art would consider equivalent to the recited value (i.e., having the same function or result). In many instances, the terms “about” may include numbers that are rounded to the nearest significant figure.
The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).
As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term “or” is generally employed in its sense including “and/or” unless the content clearly dictates otherwise.
The following description should be read with reference to the drawings wherein like reference numerals indicate like elements throughout the several views. The drawings, which are not necessarily to scale, depict illustrative embodiments of the claimed invention.
The invention pertains generally to devices that are adapted to reduce movement that may otherwise be transmitted to a distal region of an elongate shaft such as a guidewire or a filterwire. Movement reduction may be accomplished in a variety of manners.
The hub 10 includes a distal end 16 that may, if desired, include a luer fitting that is adapted to be secured to any number of medical devices such as a guide catheter, and a proximal end 18. The proximal end 18 may be configured to permit access to the hub lumen 14 so that wires, catheters and the like may be advanced through the hub 10 and into a guide catheter that may, as noted, be secured to the distal end 16. In some instances, although not required, the proximal end 18 may include a rotating hemostatic valve. In some cases, as illustrated, the hub 10 may include a Y-adaptor 20 that can be used for injecting fluid and other uses as are known.
The hub 10 also includes a magnetic column 22. As will be discussed hereinafter, the magnetic column 22 may serve to stabilize or secure an elongate shaft such as a wire extending through the hub 10, in some instances, magnetic column 22 is positioned about or within the hub body 12 such that the magnetic column 22 at least partially surrounds the hub lumen 14. In some cases, the magnetic column 22 may extend at least about halfway around the hub lumen 14, or may even extend up to about three quarters of the way around the hub lumen 14. To put it another way, the magnetic column may, in some instances, extend from about 180 degrees to about 270 degrees around the hub lumen 14.
The magnetic column 22 may be formed from a single magnet, or may, as illustrated, include a number of individual magnets 24. In some cases, the magnet or magnets forming the magnetic column 22 may be molded within the hub body 12. In other instances, as will be discussed in greater detail hereinafter with respect to
Turning now to
The sheath 26 may function to reduce the magnetic field that would otherwise permeate the hub lumen 14 as a result of the presence of the magnetic column 22. The sheath 26 does not, properly speaking, shield or stop magnetic field lines from entering the hub lumen 14 in the manner that lead stops X-rays, for example. Rather, the sheath 26 reduces the magnetic field within the hub lumen 14 by providing an alternate route for the magnetic field lines to follow.
Magnetic field lines emanating from a magnet travel between the north pole of the magnet and the south pole of the magnet. In doing so, however, magnetic field lines will follow the path of least resistance. Air, for example, has a magnetic permeability of about 1. Some materials, however, have magnetic permeability values that are much, much higher. Magnetic field lines emanating from the magnetic column 22 will follow a high magnetic permeability material, if it is present, rather than extending through the air. Thus, forming the sheath 26 of a high magnetic permeability material means that when the sheath 26 is disposed within the hub lumen 14, the magnetic field lines emanating from the magnetic column 22 will travel through the walls of the sheath 26, rather than through the air or fluid within the hub lumen 14.
A variety of high magnetic permeability materials are known. Examples include METGLAS®, which is a commercially available material containing largely cobalt, along with relatively minor amounts of nickel, iron, silicon and boron. This material has a magnetic permeability as high as about 1,000,000 and is available in thicknesses as little as 0.00065 inches (16 microns). Other suitable materials include alloys containing substantial amounts of nickel.
In order for the magnetic column 22 to stabilize or otherwise secure or immobilize the wire 28, at least a portion of the wire 28 may include or be formed from a material that responds to magnetic fields. For example, certain stainless steel alloys are known in the art as being responsive to magnetic fields. The wire 28 itself may be formed of a magnetically-responsive material, or may include an insert or even a coating of such a material.
In some cases, only a proximal portion, i.e. the portion disposed within the hub 10 may include a magnetically-responsive material. Other portions of the wire 28 may be formed of any metallic or polymeric material possessing desired strength characteristics. Examples include carbon fiber, liquid crystal polymer, or even a fiber-reinforced polymer or polymer blend.
It will be recognized, then, that as long as the sheath 26 is disposed within the hub lumen 14 such that wire 28 passes through the sheath 26, the wire 28 will be at least partially shielded from the magnetic field lines emanating from magnetic column 22. As a result, the wire 28 may be moved relative to the hub 10. If the sheath 26 has been removed, however, the magnetically-responsive portion or portions of the wire 28 will respond to the magnetic field generated by the magnetic column 22, and the wire 28 may be held motionless with respect to the hub 10.
As illustrated, the sheath 26 is disposed within the hub lumen 14. In some cases, the sheath 26 may be removed by pulling the sheath 26 proximally through the proximal end 18 of the hub 10. It will be recognized that the sheath 26 may be formed of a material that is thin enough to be easily torn. Thus, in some instances, it may be useful to remove the sheath 26 by pulling the sheath 26 proximally through Y-adaptor 20, tearing the sheath 26 away from the wire 28.
One useful application for the hub 10 can be seen in
The embolic protection device 36 may include a filter loop 40 and a filter membrane 42 that is secured to the filter loop 40. In some cases, if desired, filter membrane 42 may be drilled (for example, formed by known laser techniques) or otherwise manufactured to include a plurality of openings 44. These holes or openings 44 can be sized to allow blood flow therethrough but restrict flow of debris or emboli floating in the body lumen or cavity.
In general, embolic protection device 36 may be adapted to operate between a first generally collapsed configuration and a second generally expanded configuration (as shown in
One or more struts 45 may extend between filter loop 40 and wire 28. Strut 45 may be secured at one end to the filter loop 40 and at the other end to the wire 28. Strut 45 may be secured at either end in any suitable manner, including soldering, laser welding, adhesives, or mechanically such as by wrapping one end of strut 45 several times about filter loop 40 and wrapping the other end of strut 45 several times about the wire 28. It will be recognized the configuration and even the number of struts 45 may be tailored and/or customized for a particular intervention.
In some cases, the wire 28, bearing the embolic protection device 36, may be extended through hub lumen 14 and through guide catheter 38 while the embolic protection device 36 is in its generally collapsed configuration. While extending the wire 28, it is contemplated that the sheath 26 remains within hub lumen 14 in order to at least partially reduce the magnetic field within the hub lumen 14 that would otherwise exist. As a result, the wire 28 may move relative to the hub 10.
Once the embolic protection device 36 has reached a desired location, it may be deployed by urging the embolic protection device 36 into its generally expanded configuration. Once the embolic protection device 36 has been deployed, the relative position of the wire 28, and hence the embolic protection device 36, may be stabilized by removing the sheath 26 from the hub lumen 14, as discussed previously with respect to
As illustrated thus far, the magnetic column 22 has been shown as being molded into the hub body 12. The magnetic column 22, as discussed, may be a single magnet or a number of individual magnets. In some instances, however, a magnetic column may be disposed exterior to the hub body 12.
The hinge 55 may be any suitable hinge that permits the magnetic column 54 to be movable between a position in which the magnetic column 54 is at least partially removed from the hub 46 (as illustrated) and a position in which the magnetic column 54 is disposed about the hub 46. Thus, it can be seen that the magnetic column 54 may be easily moved between the illustrated position in which a wire may be freely moved and a position in which wire movement is restricted or prevented.
While not illustrated, it is also considered that a magnetic column 60 (
The attachment section 72 may be adapted to secure the clamping apparatus 68 to a medical device such as a hub, a guide catheter, or the like. The attachment section 72 may include any suitable attachment mechanisms, such as an adhesive that permits securement to an appropriate medical device. In some instances, the attachment section 72 may provide mechanical attachment, such as a clamp, hook and loop securement, or the like, to an appropriate medical device.
The clamping section 74 includes a first clamp 76 and a second clamp 78. The first clamp 76 and the second clamp 78 may each be convertible between an open position in which an elongate medical device such as a catheter or other therapeutic device may fit through the clamp and a closed position in which a wire such as a guidewire or a filterwire is at least partially constrained from movement. The first clamp 76 and the second clamp 78 may each, independently, be either mechanically or electromagnetically activated.
The clamping apparatus 68 is configured to be used in conjunction with a catheter or similar device that includes a monorail section. In some instances, such a catheter may be referred to as a single operator exchange catheter or a rapid exchange catheter. Such catheters may have a relatively short guidewire lumen position at or near the distal end of the catheter. The guidewire lumen may be relatively short, such as, for example, about 10 to about 20 centimeters in length. This permits a physician or other professional to easily and quickly exchange one device for another over a single guidewire or filterwire.
The first clamp 76 and the second clamp 78 may, therefore, be positioned a distance apart that accommodates the monorail section of a catheter. In some instances, the first clamp 76 and the second clamp 78 may be fixedly secured to the body 70 and may be spaced apart an appropriate distance, as discussed. In some cases, it is contemplated that one of the first clamp 76 and the second clamp 78 may be fixedly secured to the body 70 while the other of the first clamp 76 and the second clamp 78 may be movably secured to the body 70. Thus, a physician or other profession may adjust the inter-clamp spacing in order to accommodate a particular exchange device.
An illustrative but non-limiting use of the clamping apparatus 68 is seen in
In use, the first clamp 76 may be closed to secure the wire 86 in position. Then, the exchange device 88 may be advanced over the wire 86 such that the wire 86 enters the distal end 90 and exits through the guidewire port 92. At this point, the monorail section of the exchange device 88 may be positioned between the first clamp 76 and the second clamp 78. The exchange device 88 may extend proximally radially apart from the wire 86 (as shown), or the exchange device 88 may remain parallel to the wire 86.
Next, the second clamp 78 may be closed to secure the wire 86 and the first clamp 76 may then be opened to permit the exchange device 88 to continue distally into the hub 80 and then into any appropriate guide catheter or other elongate device to which the hub 80 is secured. To subsequently remove the exchange device 88, the exchange device 88 may be moved proximally until the monorail section thereof is disposed between the first clamp 76 and the second clamp 78. The first clamp 76 may be closed to secure the wire 86, and the second clamp 78 may be opened to permit the exchange device 88 to continue moving proximally.
The anchor 100 may be formed of any suitable material and having any suitable dimensions. In some instances, the anchor 100 may have a largely cylindrical shape. In some cases, the anchor 100 may instead include two or more segments that are anchored at one end to the interior of the lumen 96 and that extend proximally within the lumen 96 at the other end thereof.
In
In some instances, the anchor 100 may be biased into the open configuration. Thus, if it is desired to restrain the wire 102 from movement, the hypotube 104 may be moved distally until the anchor 100 has been moved into the closed configuration. Subsequent proximal movement of the hypotube 104 may permit the anchor 100 to revert to the open configuration and thus permit the wire 102 to move once again.
In some cases, the anchor 100 may be moved into the closed configuration so that another device may be advanced through the guide catheter 94. As the anchor 100 is located close to the distal end 98 of the guide catheter 94, it can be seen that the anchor 100 may be used to constrain movement of the wire 102 while the new device is advanced quite a ways over the wire 102. Only once the new device is proximate the anchor 100 does the anchor 100 need to be moved back into the open configuration.
In the closed configuration, the inflatable balloon 116 extends a substantial distance into the lumen 110 such that the inflatable balloon 116 in fact restrains movement of the shaft 114. In the open configuration, the inflatable balloon 116 does not extend substantially into the lumen 110, and other devices may be advanced over the shaft 114 and over the inflatable balloon 116.
The shaft 114 may include an inner lumen (not illustrated) that is in fluid communication with an interior of the inflatable balloon 116 for purposes of inflating and deflating the inflatable balloon 116. Any suitable inflation fluid may be used. In some instances, saline may be an appropriate inflation fluid as saline is essentially incompressible, and is safe for the patient if there are any leaks.
In some cases, the inflatable balloon 116 may be inflated, or moved into the closed configuration, so that another device may be advanced through the guide catheter 108. As the inflatable balloon 116 is positioned close to the distal end 112 of the guide catheter 108, it can be seen that the inflatable balloon 16 may be used to constrain movement of the shaft 114 while the new device is advanced quite a ways over the shaft 114. Only once the new device is proximate the inflatable balloon 116 does the inflatable balloon 116 need to be deflated, or moved back into the open configuration.
In some instances, there may be a desire to immobilize the shaft 114 while not entirely sealing off the lumen 110 within the guide catheter 108. As shown in
The devices described herein may include a variety of different materials. These materials may include metals, metal alloys, polymers, metal-polymer composite, and the like, or any other suitable material. Some examples of suitable metals and metal alloys include stainless steel, such as 304V, 304L, and 316LV stainless steel; mild steel; nickel-titanium alloy such as linear-elastic or super-elastic nitinol, nickel-chromium alloy, nickel-chromium-iron alloy, cobalt alloy, tungsten or tungsten alloys, MP35-N (having a composition of about 35% Ni, 35% Co, 20% Cr, 9.75% Mo, a maximum 1% Fe, a maximum 1% Ti, a maximum 0.25% C, a maximum 0.15% Mn, and a maximum 0.15% Si), hastelloy, monel 400, inconel 825, or the like; other Co—Cr alloys; platinum enriched stainless steel; or other suitable material.
Some examples of suitable polymers may include polytetrafluoroethylene (PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylene propylene (FEP), polyoxymethylene (POM, for example, DELRIN® available from DuPont), polyether block ester, polyurethane, polypropylene (PP), polyvinylchloride (PVC), polyether-ester (for example, ARNITEL® available from DSM Engineering Plastics), ether or ester based copolymers (for example, butylene/poly(alkylene ether) phthalate and/or other polyester elastomers such as HYTREL® available from DuPont), polyamide (for example, DURETHAN® available from Bayer or CRISTAMID® available from Elf Atochem), elastomeric polyamides, block polyamide/ethers, polyether block amide (PEBA, for example available under the trade name PEBAX®), ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE), Marlex high-density polyethylene, Marlex low-density polyethylene, linear low density polyethylene (for example REXELL®), polyester, polybutylene terephthalate (PBT), polyethylene terephthalate (PET), polytrimethylene terephthalate, polyethylene naphthalate (PEN), polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI), polyphenylene sulfide (PPS), polyphenylene oxide (PPO), poly paraphenylene terephthalamide (for example, KEVLAR®), polysulfone, nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon), perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin, polystyrene, epoxy, polyvinylidene chloride (PVdC), polycarbonates, ionomers, biocompatible polymers, other suitable materials, or mixtures, combinations, copolymers thereof, polymer/metal composites, and the like.
In addition, the devices described herein may also be doped with or otherwise include a radiopaque material. Radiopaque materials are understood to be materials capable of producing a relatively bright image on a fluoroscopy screen or another imaging technique during a medical procedure. This relatively bright image aids the user of filtering device in determining their location. Some examples of radiopaque materials can include, but are not limited to, gold, platinum, molybdenum, palladium, tantalum, tungsten or tungsten alloy, plastic material loaded with a radiopaque filler, and the like.
The invention should not be considered limited to the particular examples described above, but rather should be understood to cover all aspects of the invention as set out in the attached claims. Various modifications, equivalent processes, as well as numerous structures to which the invention can be applicable will be readily apparent to those of skill in the art upon review of the instant specification
This application claims the benefit of U.S. Provisional Application No. 60/805,820, entitled “WIRE STABILIZATION,” filed Jun. 26, 2006, the entirety of which is herein incorporated by reference.
| Number | Date | Country | |
|---|---|---|---|
| 60805820 | Jun 2006 | US |
